September 22, 2008

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Lynn L. Bergeson, “FDA’s Regulation of Nanotechnology: Will the New Draft Guidance Help Industry?,” Nanotechnology Law & Business, Volume 8, Issue 3.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