January 1, 2009

Lynn L. Bergeson, “Chemical Regulation: Preparing to Address the Challenges Ahead,” Environmental Law Reporter, January 2009.

The environment has enjoyed unprecedented attention as a presidential campaign issue. While climate change, energy, and resource issues dominate, chemical regulation reform is plainly a topic gathering steam. As we approach a new year, a new Administration, and a new Congress, there is much to consider. Issues pertinent to chemical management are complicated, the rhetoric is strident, and areas on which stakeholders agree appear to be few and far between. This Article offers a few thoughts on...
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 correlate the...
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Lynn L. Bergeson, “FDA’s Regulation of Nanotechnology: Will the New Draft Guidance Help Industry?,” Nanotechnology Law & Business, Volume 8, Issue 3.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...