All Published Articles

Lynn L. Bergeson, "EPA Working on Test Rule for Multi-Wall Carbon Nanotubes/TSCA Section 8(a) Rule for Several Nanoscale Substances," NanoBusiness Alliance Newsletter, Issue 8, June 18, 2009.

As you may know, twice each year the U.S. Environmental Protection Agency (EPA) publishes a detailed listing of all matters on which it is working. The document is referred to as the Semiannual Regulatory Agenda, and is published each spring and fall. The most recent spring issue was published on May 11, 2009.

Lynn L. Bergeson, "Anti-Terrorism Mandates Face Major Revision: Prospective legislation may put more emphasis on inherent safety," Chemical Processing, June 2009.

Congress is currently focusing on a key piece of legislation to reauthorize the Chemical Facility Anti-Terrorism Standards (CFATS), set to expire on October 4. This may lead to measures that are more far reaching and have a more significant impact upon the chemical industry.

Lynn L. Bergeson, "EPA Updates IRIS Process, Again," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 10, No. 4, June 2009.

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 scientific integrity of the IRIS process.”

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.

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 how best to prepare for effective chemical regulation reform. 

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.

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. 

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