All Published Articles

Lynn L. Bergeson and Michael F. Cole, "Food and Drug Administration’s Regulation of Nanotechnology," Daily Environment Report, Sep. 22, 2008.

The Food and Drug Administration is considering further implementation of the recommendations made by its Nanotechnology Task Force in July 2007. The authors of this article note that nanotechnology will be a fact of life for FDA-regulated products for years to come. They say nanotechnology is an important issue, but only one among many that FDA must address, and FDA’s limited resources must be allocated sensibly. The authors suggest FDA build on existing databases and correlate the information from submissions required for certain products. When the facts clearly warrant it, the authors recommend FDA issue guidance documents that set forth the issues to address in making filing determinations, but the need for such filings should follow the established, existing framework unless and until that framework is proven inadequate.

Lynn L. Bergeson, "EPA Seeks Big Help with Nanomaterials Data," Chemical Processing, October 2008.

The nominal deadline to submit basic information on nanoscale materials under the Nanoscale Materials Stewardship Program (NMSP) of the U.S. Environmental Protection Agency (EPA) was July 28. While the deadline has passed, EPA is encouraging entities to submit information on an ongoing basis. The program objectives and how EPA will use the information to assess additional regulatory steps applicable to nanoscale materials deserve some attention.

Lynn L. Bergeson, "The New Business of Nanotechnology: Exploring Commercial Opportunities and Risks," Environmental Claims Journal, April 2008.

There is an Alice-in-Wonderland awe associated with nanotechnology. While the technology is both exciting and hopeful for many good reasons, for businesses, and the lawyers who counsel them, the lack of certainty in areas involving potential risk is unsettling. The U.S. Environmental Protection Agency (EPA) is only now beginning to think through how best to apply the authority it has under the traditional environmental statutes, and to adopt regulatory programs and policies to address the potential risks and regulatory challenges nanotechnology invites. While research is progressing briskly on key hazard and exposure nanotechnology issues, much remains to be done leaving commercial applications of nanotechnology in new, unsettled waters. This article identifies some of these challenges and the non-conventional, innovative ways that lawyers, business managers, risk assessors, and others must embrace to manage risk and avoid liability effectively.

Lynn L. Bergeson, "Good Governance: Evolution of the Nanoscale Materials Stewardship Program," Nanotechnology Law & Business, Winter 2007.

Governance issues are seldom the subject of wide consensus, and the question of how best the U.S. Environmental Protection Agency (EPA) should obtain needed information and data on the human health and environmental implications of nanoscale materials is no exception. EPA has considered the issue carefully and believes, with good reason, that a voluntary approach makes the most sense at this time. Not everyone agrees, however, and some urge EPA to exercise its statutory authority under the Toxic Substances Control Act (TSCA) to mandate the submission of information and data, and to do so quickly. This article discusses the origins and current status of EPA’s voluntary Nanoscale Materials Stewardship Program (NMSP), outlines the key issues EPA confronted in developing the Program, and discusses the reasons why it is critically important for nanotechnology stakeholders to participate in the Program early and robustly. While stakeholders may not agree on what is the best way for EPA to obtain information on nanoscale materials, there is broad consensus that NMSP participation is critically important to maintain the public trust and confidence in this emerging technology, to provide EPA with needed information and data, and to demonstrate that potentially more burdensome rulemaking initiatives are not needed to achieve these goals. 

Lynn L. Bergeson, "The EPA’s Toxic Substances Control Act: What you must know," Environmental Expert Newsletter, November 2007.

Does the nanoscale substance you are producing or using require approval under the U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA)? It does if it’s new. But what exactly is “new?” 

Lynn L. Bergeson, co-author, "TSCA and Engineered Nanoscale Substances," Sustainable Development Law and Policy, Fall 2007.

Nanotechnology is now the subject of much excitement and attention, with applications proliferating quickly. Thus, engineered nanoscale materials’ (“ENM”) implications for human health and the environment, and the critical need for governments throughout the world to get the policy and regulatory framework right has garnered much attention. Most would agree that the ultimate goal for society is to enable nanotechnology to realize its potential while effectively addressing the pertinent environment, health, and safety (“EHS”) issues associated with ENM.

Lynn L. Bergeson, "EPA Issues Draft NMSP Concept Paper and TSCA Inventory Paper," Small Times Magazine, August 10, 2007.

The EPA's recently released paper, TSCA Inventory Status of Nanoscale Substances -- General Approach, is important for developers of nanotechnologies. Nanomaterials that meet the Toxic Substances Control Act (TSCA) definition of "chemical substance" are subject to TSCA reporting requirements because they may exhibit properties different from the same substances in the bulk scale. A chemical substance means, in relevant part, "any organic or inorganic substance of a particular molecular identity." 

Lynn L. Bergeson, "TSCA Inventory Status of Nanoscale Substances a Must-Read for Materials Developers," Small Times Magazine, August 10, 2007.

The EPA's recently released paper, TSCA Inventory Status of Nanoscale Substances -- General Approach, is important for developers of nanotechnologies. Nanomaterials that meet the Toxic Substances Control Act (TSCA) definition of "chemical substance" are subject to TSCA reporting requirements because they may exhibit properties different from the same substances in the bulk scale. A chemical substance means, in relevant part, "any organic or inorganic substance of a particular molecular identity." 

Lynn L. Bergeson, "EPA Issues Draft NMSP Concept Paper and TSCA Inventory Paper," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 8, No. 3, August 2007.

On July 12, 2007, the U.S. Environmental Protection Agency (EPA) published in the Federal Register three separate notices related to the long-awaited Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA). All of the notices and accompanying documents are available online.

Lynn L. Bergeson, "Changing the Guard: Implications of the Democratic Midterm Election Win on Environment, Energy, and Resources Legislation," Environmental Quality Management, Spring 2007.

The November 2006 mid-term elections portend a number of significant Congressional changes. There is no doubt that Democratic leadership in both the House and Senate will shake things up. Some in the business community are buckling their seat belts and preparing for a bumpy ride. Here are a few thoughts on the shape of things to come.

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