Law and the Environment : Environmental Lawyer & Attorney : Foley Hoag Law Firm : Boston, Washington D.C.

The BNA reported today that the Massachusetts Office of Technical Assistance and Technology has developed a guidance document identifying considerations for the safe development of engineered nanoparticles, or ENPs. As many of my readers know, I am deeply suspicious of regulatory agency guidance documents. Guidance is often used as a short-cut so that the agency can avoid notice and comment rule-making. Moreover, it’s generally one-sided; agencies refuse to be bound by guidance, because “it’s only guidance,” but street level bureaucrats effectively treat the guidance as regulations, so that the regulated community is effectively deprived of the flexibility that guidance is supposed to provide.

I’m pleased to say, however, that the OTA guidance appears to be a thoughtful, measured approach to safe handling of ENPs. My view is apparently corroborated by the NanoBusiness Alliance, which, according to the BNA, supports the guidance.

In this case, the guidance clearly is not a trick to avoid notice and comment rule-making. It will be issued by the OTA, which has no regulatory authority. Instead, the guidance appears to advance two goals. First, offers a simple compendium of generally reasonable steps to take to minimize the risks associated with the manufacture, handling, use, and disposal of ENPs. Second, it is intended to be a confidence builder. As the OTA notes, “increasing confidence and trust can enhance commercial prospects” for ENPs.

I certainly expect some kind of robust regulatory regime focused on ENPs down the road. However, it’s important, in this nascent state of the technology, that advocates of the precautionary principle not be in a position impose regulations that could stifle the development of a set of technologies that have so much promise in so many fields – including environmental protection. In this context, guidance such as that set forth by the OTA seems an appropriate effort at facilitating appropriate management practices without unduly burdening nanotechnology business.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

As I have previously noted, Cass Sunstein, now head of the Office of Information and Regulatory Affairs at OMB under Obama, has called the precautionary principle “deeply incoherent.” Why? Because, as Sunstein notes, “costly precautions inevitably create risks.”

I hope that Sunstein is as troubled as I am by the news, reported recently by Inside EPA, that Mathy Stanislaus, head of EPA’s Office of Solid Waste & Emergency Response, has said that implementing the precautionary principle is a key to EPA’s environmental justice efforts.

When Stanislaus says that “we can’t wait until we have all the conclusive interpretive science to make a decision,” I agree with him, but that’s not the precautionary principle, that’s just a willingness to regulate under uncertainty, which has been a bedrock of environmental law.

However, the precautionary principle is something different and much more insidious. It’s not “regulate in spite of uncertainty” – it’s “regulate because of uncertainty.” It seems to stem from an almost Luddite fear of new technology and, as Sunstein points out, a philosophical view that nature is good and man-made is bad.

Stanislaus is head of OSWER. Is he going to oppose use of new cleanup technologies based on nanotechnology, because the precautionary principle says that we don’t know that nanomaterials are safe?

Stanislaus wants to “operationalize the precautionary principle.” Be worried, be very worried.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Earlier this month, EPA released its semi-annual regulatory agenda. True policy wonks can review the agenda here. There are always some nuggets buried in the agenda. This agenda includes two proposed rules governing nanotechnology. They are:

A reporting rule under § 8(a) of TSCA. The rule would require persons who manufacture nanoscale materials to notify EPA of information concerning production volume; methods of manufacture and processing; exposure and release information; and available health and safety studies.

A test rule under § 4(a) of TSCA. The proposed rule would apply to “certain multi-wall carbon nanotubes and nanosized clays and alumina.”

Since the entire point of nanomaterials is that they act differently than the same materials as sizes beyond the nanoscale, it is certainly conceivable that such differences could include impacts on human health and the environment. EPA can therefore reasonably propose rules such as described in the regulatory agenda, requiring testing and reporting. My concern is that EPA not leap to conclusions. EPA often has to regulate under uncertainty; I just don’t want the agency to regulate simply because of uncertainty. Nanomaterials hold the promise of contributing to the solution of numerous environmental problems, even aside from their overall economic promise. 

If EPA were to obstruct the development and use of nanomaterials on the basis of the precautionary principle, the environment, as well as the economy, would likely suffer. Since Cass Sunstein, head the Office of Information and Regulatory Affairs at OMB, has called the precautionary principle “deeply incoherent,” let’s hope that EPA will proceed cautiously, gathering information necessary to determine if regulations are necessary, but not rushing willy-nilly to throw roadblocks in the way of such promising technology.

• Email This
• Print
• Comments
• Trackbacks
• Share Link