The U.S. Environmental Protection Agency (EPA) announced on May 21, 2009, that it has reformed the Integrated Risk Information System (IRIS), again. According to EPA, the revisions are intended to “revitalize the program and ensure its scientific quality, integrity, transparency and timeliness.” In a May 21, 2009, memorandum, Administrator Jackson states that recent changes, including procedures formalized in an April 21, 2008, memorandum, “have reduced the transparency, timeliness, and...
April 21, 2009
Lynn L. Bergeson, “What’s New in Nanotechnology Regulations,” Manufacturing Today, Spring 2009.
Over the last several months, there have been a number of significant nano regulatory developments. The U.S. Environmental Protection Agency (EPA) released on Jan. 12, 2009, its interim report on the Nanoscale Materials Stewardship Program (NMSP). On Jan. 22, 2009, the California Department of Toxic Substances Control (CDTSC) issued a data call-in for certain nanoscale substances....
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...
January 1, 2009
Lynn L. Bergeson, “Legislators Set Agenda for Change,” Chemical Processing, January 2009.
Regulations are expected to target the chemical industry in 2009. The new Administration and Congress promise an eventful new year — It may result in significant changes in direction for regulation of chemicals by the U.S. Environmental Protection Agency (EPA). Here’s a look at possible trends....
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...
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....
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...
November 1, 2007
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?” ...