Oversight of Nanomaterials Lags

Posted on December 30, 2011 by Leslie Carothers

The cover of Time magazine’s recent issue on inventions depicts a motorized hummingbird, a mini-machine, enabled by nanotechnology, that can mimic the bird’s flight capability and conduct surveillance operations.  Other nanomaterial inventions --using particles at the scale of one billionth of a meter-- include an industrious particle that can hunt down and kill cold viruses.  Amen to that.  As the science of nanomaterials continues to amaze, how are we doing on the governance front to be ready to manage its potential risks to health and the environment? 

The departure of Steve Owens, EPA Assistant Administrator for Prevention, Pesticides, and Toxic Substances, concludes a notable effort to address governance issues in the nano realm; but at the end of 2011, major initiatives to obtain the information needed for a credible oversight program remain incomplete. Under the prior administration, EPA  requested voluntary submittal of data from nanomaterial producers.  About 30 organizations submitted data on 130 materials.  Not surprisingly, only a handful accepted the invitation to conduct voluntary testing for EPA.  The results satisfied no one.  Under Mr. Owens, EPA developed a package of proposed rules under the Toxic Substances Control Act (TSCA) including a Section 4 test rule, a significant new use rule under Section 5 addressing nanomaterials based on chemical substances listed in the TSCA inventory and a Section 8(a) information gathering rule.  These proposals have been under review at OMB’s Office of Regulatory Information and Review (OIRA) for over a year.   

Meanwhile, OIRA, along with the Office of Science and Technology and the Office of the Trade Representative, issued a 5 page memorandum in June, 2011, to provide policy guidance for the multiple federal agencies dealing with nanomaterials under legal oversight authorities.  The memorandum describes the many benefits of nanomaterials, while also acknowledging the need for further scientific work on health and environmental issues as a predicate for appropriate risk management actions.  The only sign that the writers recognize any legal issues complicating action under TSCA or other statutes is a statement  that some statutes may limit mandatory reporting or information gathering to circumstances “where a risk or harm has already been identified,” TSCA’s well known catch-22 in establishing test rules.    This observation is followed by a Delphic reference to agencies’ need “to explore other legally available means to obtain the information necessary to assess risk and possible harms.”  What this means for EPA’s pending proposals is anybody’s guess. 

Information reporting rules for nanomaterials are not easy to develop. EPA must define categories of materials to be reported on, the types of products and facilities to be covered, and the level of detail on product composition and potential impacts from emissions or disposal needed to understand exposures while minimizing the burden of reporting.  In other countries such as France and Canada, efforts  to set mandatory reporting rules have been bedeviled by definitional issues.  France has also faced the challenge of, harmonizing its rules with the European Union’s chemical regulation scheme.   Canada’s Health Agency recently issued a policy statement with a working definition for nanomaterial for use in data reporting at some future time under its existing legal authorities.
                                                 
EPA’s ability to obtain basic information on the production and use of important categories of nanomaterials remains a prerequisite for minimal oversight of the nanomaterials industry offering some assurance to the public that if health or environmental risks are identified by research, they can be addressed without undue delay.  The program begun by Mr. Owens ought to move forward for public review and comment. 

 

Leslie Carothers
Scholar-in-Residence and Adjunct Professor
Pace Law School



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