All Published Articles

J. Brian Xu, M.D., Ph.D., DABT® and Scott J. Burya, Ph.D., "FCM regulations in China and the US - a comparison," CW+ AsiaHub, July 18, 2018.

While the intention of food contact regulations in both China and the US is to protect public health, the approaches taken, the obligations for industry and other facets of the regulations differ in notable ways. This article overviews the two regulatory systems, highlighting key similarities and differences between the emerging regulatory regime in China and the established US Food and Drug Administration (FDA) food contact regulations.

Lynn L. Bergeson, "EFSA Publishes New Guidance on Nanotechnologies in Food and Feed," Nanotechnology Now, July 5, 2018.

The European Food Safety Authority (EFSA) issued a July 4, 2018, press release announcing the availability of new guidance on how to assess the safety of nanoscience and nanotechnology applications. The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011. 

Lynn L. Bergeson, "EPA Eyes Nonylphenol Ethoxylates," Chemical Processing, June 20, 2018.

The U.S. Environmental Protection Agency (EPA) expanded on June 12, 2018, the list of chemicals subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxics Release Inventory (TRI). The list now includes a category containing 13 nonylphenol ethoxylates (NPE). NPEs are nonionic surfactants used in a variety of industrial applications and consumer products including adhesives, wetting agents, emulsifiers, stabilizers, dispersants, defoamers, cleaners, paints and coatings. The final rule will apply for the reporting year beginning January 1, 2019, with the first reporting forms due July 1, 2020. This development will impact chemical stakeholders in a range of commercial applications, as explained below.

Lynn L. Bergeson, "Environmentally Sound," Manufacturing Today, May 29, 2018.

On March 16, 2018, the U.S. Environmental Protection Agency (EPA) proposed to add hazardous waste aerosol cans to the category of “universal wastes” regulated under the federal Resource Conservation and Recovery Act (RCRA) regulations, codified at Title 40 of the C.F.R., Part 273. 83 Fed. Reg. 11654. According to EPA, this action would benefit the many manufacturing facilities and others that generate and manage large quantities of hazardous waste aerosol cans.

Lynn L. Bergeson, "USDA Eyes Bioengineered Food Standard," Chemical Processing, May 21, 2018.

On May 4, 2018, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) proposed a rule to establish the first ever National Bioengineered Food Disclosure Standard (NBFDS) mandated by Congress in 2016. This column discusses the proposal, what it intends to achieve, and its implications.

Lynn L. Bergeson, "EPA Continues to Investigate Engineered Nanomaterials in Industrial Wastewater Discharge," Nanotechnology Now, May 2, 2018.

On May 2, 2018, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing publication of its Final 2016 Effluent Guidelines Program Plan. The Plan describes EPA's Clean Water Act rulemakings and other actions intended to control industrial wastewater pollution. 

Lynn L. Bergeson, "TSCA tips for European chemical stakeholders," Elements, the Magazine of Chemicals Northwest, Spring, 2018.

Changes to the Toxic Substances Control Act (TSCA) occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act have fundamentally changed the way the US Environmental Protection Agency (EPA) reviews new and assesses existing chemical substances in surprising and subtle ways. Our 26-professionals TSCA practice in Washington, D.C. has been “doing TSCA” for a very long time. We offer our European colleagues practical insights into the new law and EPA’s implementation efforts. As we represent many European companies that have business interests in the U.S., our views are offered from a practical perspective.

Lynn L. Bergeson, "EPA Proposes TSCA User Fees," Environmental Quality Management, Volume 27, Issue 3, Spring 2018.

We all knew it was coming, and the proposal has finally arrived. On February 8, 2018, the US Environmental Protection Agency (EPA) announced that EPA Administrator Scott Pruitt signed a proposed rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA). As amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides the EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law” (EPA, 2018a, p. 1). This column summarizes the proposal and explains why it is significant.

A downloadable and printable version of this article is available here

Lynn L. Bergeson, "Chemical Compliance: Deadline Looms for Prop 65," Chemical Processing, April 20, 2018.

In just a few short months, on August 30, 2018, the California Office of Environmental Health Hazard Assessment (OEHHA) revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations will come into force. By then, companies must be compliant with the revised regulations for consumer product, occupational and environmental exposures.

Lynn L. Bergeson, "OECD Evaluates Application of In Vitro Methods for Human Hazard Assessment in OECD Testing Program for Safety of Manufactured Nanomaterials," Nanotechnology Now, March 29, 2018.

The Organization for Economic Cooperation and Development (OECD) has published a March 23, 2018, report entitled Evaluation of in vitro methods for human hazard assessment applied in the OECD Testing Programme for the Safety of Manufactured Nanomaterials.

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