All Knowledge & Insights By Date

On August 2, 2016, Lynn L. Bergeson, Managing Partner of B&C, presented the webinar "New TSCA's Impact on Biotechnology," with the National Academies of Sciences, Engineering, and Medicine (NAS). This webinar, available for free on the NAS website, includes an overview of TSCA updates resulting from the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Ms. Bergeson focused specifically on how these updates could impact the regulation of biotechnology,...

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On August 18, 2016, Chemical Watch quoted the Bergeson & Campbell, P.C. (B&C®) memorandum, “TSCA: Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards,” in an article examining the conflict between the U.S. Environmental Protection Agency’s (EPA) Significant New Use Rule (SNUR) proposal and the revised Occupational Safety and Health Administration's (OSHA) Hazard Communications Standard (HCS). US agency's notice...

The U.S. Environmental Protection Agency (EPA) has made much of its “Next Generation Compliance” initiative, created “to increase compliance with environmental regulations by using advances in pollutant monitoring and information technology combined with a focus on designing more effective regulations and permits to reduce pollution.” This involves more effective regulations and permits that include built-in compliance mechanisms, such as continuous monitoring for stationary sources;...

On August 11, 2016, the U.S. Environmental Protection Agency (EPA) convened a public meeting to solicit comments prior to development of a proposed rule to implement the revised Section 26 fees provision under the new Toxic Substances Control Act (TSCA).  Public comments may be submitted through regulations.gov in docket EPA-HQ-OPPT-2016-0401 until August 24, 2016. During the meeting, EPA solicited public comment in particular on the following five issues: To be able to...

It is the author’s view that the central failing of old TSCA was its inability to produce the testing needed by EPA to assess and understand the hazards, exposures, and risks of existing chemicals. New TSCA makes important changes to the authority available to EPA to compel industry to generate the information needed by EPA to meet the purposes articulated under the new law. This paper briefly reviews the issues and problems that EPA encountered in using old TSCA for this purpose, discusses...

The Frank R. Lautenberg Chemical Safety for the 21st Century Act, P.L. 114-182, significantly amends the Toxic Substances Control Act (TSCA). The Act was signed into law by President Obama on June 22, 2016. The date of signature is both the date of enactment and of entry into force of amended TSCA. New TSCA fundamentally changes the U.S. Environmental Protection Agency's (EPA) approach to evaluating and managing industrial chemicals, including genetically engineered microorganisms. The body of...

The U.S. Environmental Protection Agency (EPA) today released a pre-publication version of a Federal Register notice to be issued on August 16, 2016, extending the deadline to submit comments on draft Pesticide Registration Notice (PRN) 2016-X from August 15, 2016, to September 14, 2016.  A discussion of draft PRN 2016-X, which proposes to update Section 5 of PRN 97-2, and to clarify and update criteria by which EPA classifies crops as “minor...

On August 9 and August 10, the U.S. Environmental Protection Agency (EPA) held two public meetings to obtain input prior to development of a proposed rule for chemical risk evaluation (August 9) and a proposed procedural rule regarding prioritization of chemicals for further risk evaluation (August 10) under the new Toxic Substances Control Act (TSCA).  Bergeson & Campbell, P.C.’s (B&C®) Oscar Hernandez, Ph.D. and Richard E. Engler, Ph.D. were in attendance,...

On August 3, 2016, 24 farmer and public interest organizations wrote to the Obama Administration expressing their disappointment with the direction that the White House Office of Science and Technology Policy (OSTP) has taken with the proposed modernization of the Coordinated Framework for Regulation of Biotechnology (Coordinated Framework). The letter argues that an overly permissive regulatory framework for genetically engineered (GE) products has resulted in negative consequences, and that GE...