July 22, 2008

Lynn L. Bergeson, “FDA’s Regulation of Nanotechnology: Will the New Draft Guidance Help Industry?,” Nanotechnology Law & Business, Volume 8, Issue 3.

The U.S. Food and Drug Administration’s (FDA) approach to nanotechnology is the subject of intense interest for at least three reasons. First, many promising and visible applications of nano-technology include cosmetics, sunscreens, pharmaceuticals, dietary supplements, and medical devices. These products are subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act (FFDCA). Second, FDA faces unique challenges in regulating products of nanotechnology be-cause of the...
July 1, 2008

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....
April 1, 2008

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...
December 21, 2007

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...
September 21, 2007

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...
August 10, 2007

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...
August 10, 2007

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...
August 1, 2007

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....
March 21, 2007

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....
March 1, 2007

Lynn L. Bergeson, panel expert, “Emerging Environmental Risk: A Global View,” Risk Talk: Environmental Risk, Vol. 1, Issue 2.

This edition of Risk Talk focuses on emerging environmental risks from a global perspective. From local pollution problems to global warming, companies face a wide variety of environmental risks. The increasingly global economy requires that companies adopt a comprehensive environmental risk management strategy. Properly executed, such a strategy can give a company a competitive advantage. ...
March 1, 2007

Lynn L. Bergeson and Joseph E. Plamondon, “TSCA and Engineered Nanoscale Substances,” Nanotechnology Law & Business, March 2007.

The federal law that regulates new and existing chemical substances, including engineered nanoscale chemical substances, is the Toxic Substances Control Act (TSCA). While there is much debate over how the U.S. Environmental Protection Agency (EPA) should deploy its significant TSCA authority to address potential risks to human health and the environment posed by engineered nanoscale materials, there is no doubt that EPA is already doing so. This article provides a general overview of TSCA as...
October 1, 2006

Lynn L. Bergeson, “ABA SEER’S Review of Existing Laws and Nanotechnology,” Gradient Corporation EH&S Nano News, October 2006.

The American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER) offered to brief representatives of the US Environmental Protection Agency’s (EPA) Office of General Counsel on legal and regulatory issues arising in connection with the application of existing statutory and regulatory authorities to engineered nanoscale materials. SEER prepared briefing documents on each statute, and a separate briefing document on innovative governance mechanisms. Each document...
September 21, 2006

Lynn L. Bergeson, “Environmental Accountability: Keeping Pace with the Evolving Role of Responsible Environmental Corporate Stewardship,” Environmental Quality Management, Autumn 2006.

This “Washington Watch” column outlines the concept of environmental accountability, provides a summary overview of the many mechanisms that are included within this broad topic, and discusses the role that environmental accountability plays in influencing corporate business standards pertinent to environmental performance. As government resources earmarked for more traditional environmental enforcement and compliance-assistance initiatives continue to dwindle, environmental...
September 1, 2006

Lynn L. Bergeson and Michael F. Cole, “NanoBioConvergence—Emerging Diagnostic and Therapeutic Applications,” Bioprocessing & Biopartnering 2006: Featuring NanoBiotechnology, 2006.

Many people regard nanotechnology as a “stand-alone” technology. While the technology itself is of great interest, the most intriguing aspect of nanotechnology is that it is increasingly being utilised as an integral part of a more complicated convergence matrix. The intersection of nanotechnology, biotechnology, information technology, and cognitive science, otherwise referred to as ‘NBIC convergence’, is leading to the development of nanobiotechnology products that promise to...
July 1, 2006

Lynn L. Bergeson, “Small Sensors Promise Big Impact,” Chemical Processing, July 2006.

. In the past year, there has been an appreciable upswing in new products developed and commercialized pertinent to “intelligent” water monitoring tools and devices involving nanotechnology. Because many environmental applications of nanotechnology will almost certainly revolutionize the science, law, and regulation of water pollution, readers are urged to keep abreast of this fast-changing area....
June 21, 2006

Lynn L. Bergeson, “Key Environmental Issues: Views from Inside the Beltway and Beyond,” Environmental Quality Management, Summer 2006.

With the mid-term elections fast approaching, the Bush Administration is probably feeling a bit unsettled about its ability to defend its record on environmental accomplishments. The Bush Administration’s record on environmental accomplishments is, according to most environmental groups, weak if not downright bad. This column identifies several key environmental issues that may elicit potential voter response. ...
April 1, 2006

Lynn L. Bergeson, “Nanotechnologies and FIFRA,” Gradient Corporation EH&S Nano News, April 2006.

This column explores applications of nanotechnologies in the agricultural sector, and a few of the issues the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) is now considering regarding nanotechnologies and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)....
April 1, 2006

Lynn L. Bergeson and Michael F. Cole, “FDA Regulation of Food Packaging Produced Using Nanotechnology,” Food Safety Magazine, April/May 2006.

Food packaging materials must comply with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Nanopackaging for the most part involves the use of materials that are not intended to have any effect on the food in the package, but may contact the food if the material migrates from the packaging. Such materials are regulated as indirect food additives or food contact substances. There are precedents that permit the marketing of indirect food...
March 21, 2006

Lynn L. Bergeson, “Nanoscale Materials and TSCA:  EPA’s NPPTAC Recommends a Framework for a Voluntary Program,” Environmental Quality Management, Spring 2006.

The U.S. Environmental Protection Agency (EPA) National Pollution Prevention and Toxics Advisory Committee (NPPTAC) forwarded to EPA Administrator Stephen L. Johnson on November 22, 2005, its document entitled Overview of Issues for Consideration by NPPTAC. The Overview of Issues document sets forth NPPTAC’s “analysis and views” on a framework for a voluntary program on existing engineered nanoscale materials. The framework is intended to complement the new nanoscale chemicals requirements...
February 1, 2006

Lynn L. Bergeson, “EPA’s NPPTAC Recommends Framework for Voluntary Nanomaterials Program,” ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 7, No. 1, February 2006.

In November 2005, the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) forwarded to U.S. Environmental Protection Agency (EPA) Administrator Johnson its document entitled Overview of Issues for Consideration by NPPTAC. The Overview of Issues document sets forth the NPPTAC’s analysis and views on a framework for an approach to a voluntary program for existing engineered nanoscale materials. The framework is intended to complement the approach to the new nanoscale chemicals...
February 1, 2006

Michael F. Cole, “RFID, Nano-Tools and the Electronic Safety Net: Nanotechnology may revolutionize the use of RFID in the battle against counterfeit drug imports,” Health & Personal Care Magazine, February 2006.

Radio frequency identification (RFID) technology is revolutionizing the business of tracking inventory and, soon, the U.S. Food and Drug Administration (FDA) will use it to combat counterfeit drugs. The challenges of RFID adoption, in turn, might act as an additional impetus to the development of nanotechnology solutions. FDA views RFID as the most promising technology to combat the flow of counterfeit drugs to U.S. consumers, and encourages the adoption of RFID by manufacturers and...
December 21, 2005

Lynn L. Bergeson, “GAO Recommends TSCA Improvements, and a Senate Bill Responds with a Proposal,” Environmental Quality Management, Winter 2005.

In June 2005, the Government Accountability Office (GAO) issued a report critical of the federal government’s ability under the Toxic Substances Control Act (TSCA) to assess and prevent risks from new and existing chemical substances. Release of the GAO report coincided with the introduction by Senators Frank Lautenberg and James Jeffords of the Kid Safe Chemicals Act (S. 1391), a bill intended to improve children’s health by reducing exposure to harmful toxic chemicals in everyday...
October 21, 2005

Lynn L. Bergeson, “EPA Considers How Best to Regulate Nanoscale Materials,” Environmental Quality Management, Autumn 2005.

In a May 10, 2005, Federal Register notice, EPA announced, in an understated way, its decision to convene a public meeting on ‘nanoscale materials.’ The meeting notice represents the Agency’s first public foray into harnessing some of nanotechnology’s promise within a regulatory framework created almost three decades ago with the enactment of the Toxic Substances Control Act (TSCA)....