DuPont and Environmental Defense jointly launched their Nano Risk Framework this morning at the Woodrow Wilson International Center for Scholars. Two speakers from each principal introduced the framework, and were then followed by a panel discussion including three speakers representing other nanotechnology stakeholders.
Gwen Ruta, Director, Corporate Partnership Programs, ED spoke first regarding how the framework’s underlying partnership came into existence. She indicated that ED first became interested in nanotechnology because of its potentially promising environmental and energy saving applications. As it explored those areas, ED also became aware of potential EHS concerns surrounding the manufacturing and use of engineered nanomaterials. ED then looked for a possible corporate partner to address nano-related EHS issues in an attempt to make sure the industry, "gets it right the first time," unlike what Ms. Ruta believes transpired with CFCs, DDT, and asbestos.
Ms. Ruta indicated ED then approached DuPont and learned the corporation felt the same way ED did about addressing nano-related EHS issues earlier rather than later. Ms. Ruta further indicated that even though DuPont and ED may have different approaches, they were able to use those differences to create a strong partnership that takes advantage of divergent perspectives. She noted the framework is being implemented at an early stage in nanotechnology development and is not simply an afterthought. Ms. Ruta concluded by characterizing the framework as a "stepping stone" for future nano-related EHS efforts, a "challenge" to other companies to make similar efforts, and a challenge to EPA/FDA/OSHA to make progress on nano-related regulatory issues and fund more nano-related EHS research.
Linda Fisher, Vice President and Chief Sustainability Officer, DuPont next provided her perspective on the framework. She hoped that implementing the framework may avoid some of the pitfalls familiar to the biotechnology industry, and believed it should also provide helpful guidance to EPA as it considers how to regulate engineered nanomaterials. Additionally, Ms. Fisher indicated that DuPont has made the framework mandatory for all of its own internal products and processes using nanomaterials, and gave examples of three specific instances in which DuPont has already used the framework: (1) to evaluate a titanium dioxide material used in plastics to protect against sun penetration; (2) to evaluate the use of carbon nanotubes in certain polymer composites; and (3) to evaluate the use of zero-valent iron for environmental remediation purposes. Regarding this last instance, Ms. Fisher indicated that applying the framework showed DuPont that it lack sufficient information about some aspects of the project. DuPont then made the decision to put off pursuing a pilot test of the project until further information could be gathered. Finally, Ms. Fisher indicated that the framework is not intended to be a substitute for government regulation, although she encouraged EPA to take the framework into consideration when determining how to regulate engineered nanomaterials.
Scott Walsh, Project Manager, Corporate Partnerships Program, Environmental Defense and Terry Medley, Global Director of Corporate Regulatory Affairs, DuPont, then jointly presented an overview of the Nano Risk Framework itself. These two individuals were the team leaders for the partnership process and were repeatedly commended for all of their hard word. A link to the actual framework document is here. Messrs Walsh and Medley characterized the framework as “comprehensive, practical, and flexible.” They noted that the six step framework was designed to be applied to a variety of nanomaterials in a variety of processes/products, and is not intended to be a "one size fits all" document. To this end, Messrs Walsh and Medley noted the framework allows a company to use "reasonable worst case scenario" assumptions when existing EHS data does not exist. They also stated that at the end of the day, the framework requires the implementation of "expert judgment" and is very flexible in this regard. They also addressed criticism regarding the possible costs posed by the framework to small and mid-sized businesses. Messrs Walsh and Medley indicated the framework was designed to be flexible enough to keep costs down. To this end, they pointed to three case studies DuPont has undertaken, initial summaries of which are posted on the Nano Risk Framework website. Final versions of these case studies (when posted) are promised to include cost and labor estimates for the three above-mentioned specific situations.
The Nano Risk Framework itself is 85 pages long. We cannot cover it in full here. Nevertheless, the six basic analytical steps in the framework are:
1. Describe the nanomaterial and its intended application.
2. Create a thorough life-cycle profile of the specific nanomaterial and its intended applications. This step looks at three specific issues within the life-cycle analysis process: (a) material properties; (b) hazards; and (c) exposure possibilities.
3. Evaluate the risk posed by the particular nanomaterial in all reasonably foreseeable uses. This step requires using existing EHS data if it available. If unavailable, companies can either analogize to similar materials for which such data is available or assume a "reasonable worst case scenario."
4. Assess the risk presented by the above evaluation.
5. Make a decision about whether to proceed with the process/product, limit its scope, or stop based on the above risk assessment.
6. Review, adapt, and modify the above process as needed. This step also includes identifying specific triggers for new reviews based in part on changes in use, amount used, and/or available EHS data.
The three subsequent panel discussion speakers were:
Sean Murdock, Executive Director, NanoBusiness Alliance : Mr. Murdock applauded the robust nature of the framework and commented on how theoretically it should be equally applicable to a variety of existing chemicals that are far more hazardous than engineered nanomaterials. He also attempted to dispel the myth that most nanotechnology companies are small, unsophisticated "start-ups." He explained that many companies take EHS issues very seriously and have hired industrial hygienists and other consultants to assist them on these issues. While Mr. Murdock had questions concerning how expensive the framework might be to implement, he also believes that it provides a good first step in the right direction .
Jim Willis, Chair, Organization for Economic Co-operation and Development (OECD), Working Party on the Manufacture of Nanomaterials: Mr. Willis briefly explained the six nanotechnology projects OECD currently has underway. Here is a link to a report describing those various projects.
Andrew Maynard, Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars: Mr. Maynard believes the framework is important because it is the first comprehensive guidance document to recommend specific steps in EHS analysis related to nanomaterials. He also stated some of the largest challenges confronting the nano-industry are to move beyond a "chemical mindset" when it comes to regulation, the need to "ask the right questions in the first place" when evaluating EHS-regulatory and governance issues, and the need to mine existing nano-related EHS data for application to the situations currently confronted.
The Woodrow Wilson Center intends to post a webcast of the entire event here soon.