Last month, the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars published Terry Davies’ thoughtful paper "EPA and Nanotechnology: Oversight for the 21st Century." 

Among other notable credentials, Davies is a former EPA official from the Bush I administration and before that had a hand in drafting the plan that created EPA as well as in drafting the Toxic Substances Control Act (TSCA) back in the 1970s.  His paper contains five sections: (I) Setting an Agenda; (II) The Current Situation; (III) Tools for Dealing with Nano; (IV) EPA in the 21st Century; and (V) Next Steps. 

Each section of the paper is thoughtful and warrants separate coverage and comment, which I will not attempt here.  Of primary interest to our readers are most likely the five pages on "Reforming Regulation" which appear in the "Tools for Dealing with Nano" section.  In these pages Davies sets forth eight new possible federal regulatory approaches to nanotechnology.  The eight approaches which are not mutually exclusive follow:

1.  Collaborative Regulation:  Under this approach nanomanufacturers would be required to develop a sustainability plan under criteria and rules jointly created by EPA, FDA, USDA, CSPS and possibly other federal agencies.  These rules would contain three primary elements: (i) a life-cycle assessment of all potential environmental impacts presented by each nanomaterial or product; (ii) comprehensive toxicity and exposure data related to the particular material and its use; (iii) specific risk management steps taken by the manufacturer– including product labeling — along with an explanation of why the steps are adequate to protect against unacceptable risks. 

Under this approach, the sustainability plan would not be subject to government review or approval unless a concerned citizen petitioned for review or the government suspected the plan was fundamentally flawed in some respect.  Manufacturers would be required to update the plan on a period basis.  There would be severe penalties for noncompliance.

2.  Voluntary Plan With Strict Liability:  Under this approach nanoproducts would not be subject to premarket approval, but manufacturers would be strictly liable for any adverse health or environmental caused by their products.  The government would be authorized to sue for damages and would be given sufficient resources to monitor and detect any adverse health or environmental effects.

3.  Disclosure-Based Approaches:  Davies points to Berkeley, California’s recent nanotechnology ordinance as an example of this approach.  We have previously posted some of our thoughts about the Berkeley approach here, here, here, here, herehere, and here.  Davies also argues that this approach could contain a nano labeling requirement.

4.  Labeling and Liability:  Under this approach nanomanufacturers would be required to notify the EPA before they market nanoproducts to the public and the products would wear a label saying they employed nanotechnology.  If the products contained nanoparticles in "free form," there would be a safety screening process before marketing would be allowed, post-marketing monitoring, and a bonding requirement to cover potential liability.

5.  Trust But Verify:  The federal government would collaborate with industry trade associations to create general codes of conduct governing the uses of nanomaterials in that industry.  Trade associations would adopt these codes and compliance would be verified by the EPA or its agent.  The EPA would also be responsible for promulgating nano-specific safety tests and safeguards which would be incorporated into the codes.  The codes would also be applicable to businesses who are not part of any trade association.

6.  Coalition:  Davies suggests this approach would be structured much like the DuPont/Environmental Defense Nano Risk Framework.  Here are some previous posts about the framework: a, b, c.  Companies that complied with the framework would be entitled to label their products accordingly.

7.  Regulation with Reward:  Under this approach the EPA would establish nano-specific safety testing requirements.  If a company’s product passed these tests it could carry an EPA approved label.  If it failed the tests, the manufacturer would have to submit a risk management plan for approval by EPA.  This approach also provides other minor perks to compliant companies.

8.  Exposure-based Regulation:  Here, manufacturers would submit life-cycle exposure assessments for each product they make which would be reviewed by a variety of government agencies who would then determine what steps are needed to limit or manage potential adverse exposure.  The government could require companies to conduct any toxicity and/or ecological testing necessary for the government to make its determination.