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

In a prior rant, I raised the concern that EPA would oppose the use of new cleanup technologies based on nanotechnologies on the basis of the precautionary principle. I may not have been exactly on the mark, but I was pretty close. On Thursday, the NRDC announced that it has filed suit challenging EPA’s decision to issue a conditional registration of a nanosilver-based antimicrobial agent. The NRDC asserts that EPA’s use of the conditional registration process is “illegal,” apparently because EPA does not have sufficient information to justify a conclusion that use of the nanosilver products do not cause “unreasonable adverse effects to human health and the environment.” According to the NRDC, EPA’s decision is

just the most recent example in a long line of decisions that treats [sic] humans and our environmental as guinea pigs for these untested pesticides.

As noted in my prior post, there is a difference between regulating in spite of uncertainty – which can frequently be justified – and regulating because of uncertainty, which is deeply troubling. Nanomaterials hold great promise in a wide number of fields, including many uses – such as antimicrobials – focused on protecting public health and the environment. 

What is the basis for keeping these materials off the market just because we haven’t proved that they don’t pose a risk?

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

As EPA begins to regulate nanomaterials more aggressively, but as concerns remain regarding EPA regulatory efforts, private efforts to regulate nanomaterials continue. ASTM recently announced that it is forming a new subcommittee on Nano-Enabled Consumer Products. The focus of the subcommittee will be on uses of nanomaterials containing silver. In particular, ASTM noted that it would be considering the following possibilities:

Standards for measurement of silver in textiles and liquids (including atomic spectroscopy to  assess mass)

Standards for evaluating the form of silver in textiles and liquids (including: electron microscopy to evaluate size, shape and chemical composition; ultraviolet-visible spectrophotometry to evaluate size using surface plasmon resonance absorbance)

Standards for assessment of nanosilver exposure potential from use of textile and liquid consumer products (including: release from consumer products in biological fluids [skin surface, lung, gastrointestinal tract]; release from consumer products in environmental matrices [air, water, soil] throughout a product lifecycle).

There is little doubt that nanomaterials are a brave new world – one which indeed scares some people, notwithstanding nanotechnology’s promise. We are also entering into a brave new world of nanotechnology regulation – one which scares me a bit, notwithstanding my recognition that some careful regulation of nanomaterials may be appropriate.

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

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

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