Federal/EPA Regulatory Policy

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, "Citizens Challenge EPA," Chemical Processing, March 21, 2018.

A petition filed under Section 21 of the Toxic Substances Control Act (TSCA) was one of the first actions reviewed by a federal district court since TSCA was substantially rewritten in June 2016.The rulings described below pose interesting and potentially formidable challenges for TSCA stakeholders.

Lynn L. Bergeson and Bethami Auerbach, "Innovation, Consumer Products, and Legal Risk: Points to Consider," Paper presented at the 2017 Retail Law Conference, October 12, 2017.

Products that embody tried, true, and especially cutting-edge technologies are generally embraced by retailers as sure-fire pathways to marketing success. What’s not to like about best sellers and newer, faster, cleaner, or otherwise improved products? Sometimes overlooked is what is hidden behind the technology curtain -- what is the secret sauce that makes the product faster, cleaner, or better? In marketing products with new modes of action and spiffy new attributes, retailers are part of a product liability chain of which they need to be aware. This paper provides an overview of emerging legal and practical issues pertinent to the inclusion of technologies supporting products marketed to the public.

Lynn L. Bergeson, James V. Aidala, Jr., Charles M. Auer, Richard Engler, and Oscar Hernandez, "Practitioner Insights: Enhancing TSCA Reform Implementation," BNA Daily Environment Report, August 2, 2017.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act significantly amended the Toxic Substances Control Act. The act, which has been in force for just over a year, made substantive changes to multiple sections of TSCA that are proving to be even more consequential than anticipated (new TSCA is identified as Pub. L. No. 114-182 and old TSCA was identified as Pub. L. No. 94-469).

This paper, authored principally by former EPA officials and a practicing TSCA lawyer, all with long experience under old TSCA, provides suggestions for new approaches or ‘‘fixes’’ that could assist the agency and interested groups in moving toward smoother implementation of the new law, achieving policy goals, and ensuring greater transparency. These suggestions are presented in no particular order and in the spirit of urging other stakeholders to also think of creative ways to ensure that new TSCA fulfills Congress’s mandate to develop an effective domestic chemical management program.

Lynn L. Bergeson and Timothy D. Backstrom, "Appellate Court Vacates Conditional Nanosilver Registration," ABA Section of Environment, Energy, and Resources PCRRTK Newsletter, Volume 18, Issue 5, August 2017.

On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of a nanosilver pesticide product and vacated that conditional registration. NRDC v. EPA, No. 15-72308. The Natural Resources Defense Council (NRDC), the Center for Food Safety (CFS), and the International Center for Technology Assessment (ICTA) filed petitions in 2015 asking the court to set aside EPA’s final order granting a conditional registration for a nanosilver containing antimicrobial pesticide product named NSPW-L30SWS (NSPW). The court vacated the conditional registration because, according to the court, “EPA failed to support its finding that NSPW was in the public interest.”

Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala, "EPA’s Evaluation and Determination of Epidemiological Data for Chlorpyrifos," ABA Section of Environment, Energy, and Resources PCRRTK Newsletter, Volume 18, Issue 5, August 2017.

Among the many legal, regulatory, and policy issues being watched closely by pesticide registrants as the U.S. Environmental Protection Agency’s (EPA) long and contentious review of chlorpyrifos registrations continues is the controversy concerning when EPA may appropriately apply a tenfold uncertainty factor pursuant to the Food Quality Protection Act (FQPA 10X). This issue centers around EPA’s novel and unprecedented use of epidemiological data and the statutory requirements that govern EPA’s determination that sufficient uncertainty exists to warrant applying the FQPA 10X, not only to chlorpyrifos itself, but to all organophosphate (OP) pesticide products. This issue has drawn much attention and concern from pesticide registrants, and from other interested parties. The issues directly affecting chlorpyrifos have played out not only in EPA’s registration review process for chlorpyrifos, but also in a court challenge to EPA’s decision.

Lynn L. Bergeson, "The Final Rule," Manufacturing Today, July 21, 2017.

The U.S. Environmental Protection Agency (EPA) issued on Jan. 12, 2017, a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. This column summarizes the rule.

Lynn L. Bergeson, "EPA Issues TSCA Framework Rules," Chemical Processing, July 18, 2017.

The U.S. Environmental Protection Agency (EPA) issued in June final framework rules under the Toxic Substances Control Act (TSCA). Each is summarized in the article.

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