July 24, 2018

APHIS/USDA Prepare to Revise Regulations Pertinent to Genetically Engineered Organisms

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) signaled on June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.”  The EIS will have a significant impact on how APHIS chooses to amend its regulation of GE...
July 19, 2018

EPA Convenes Public Hearing on Proposed Rule:  Strengthening Transparency in Regulatory Science

On July 17, 2018, the U.S. Environmental Protection Agency (EPA) convened a public hearing on the proposed rule “Strengthening Transparency in Regulatory Science.” Stakeholder testimony was scheduled for the three sessions: 8:00 a.m. to 12:00 p.m., 12:00 p.m. to 4:00 p.m., and 4:00 p.m. to 8:00 p.m. Bergeson & Campbell, P.C. (B&C®) attended the morning session. A few takeaways from the meeting include: The proposed rule, issued on April 30, 2018, originally had a comment...
July 13, 2018

Recent Federal Developments – July 2018

Available On-Demand – TSCA At 2: An Update On Implementation And Hot Topics: A recording of “TSCA at 2: An Update on Implementation and Hot Topics,” the third webinar in the 2018 Chemical Policy Summit Series, is now available. This webinar featured news and updates on Toxic Substances Control Act (TSCA) implementation from Nancy B. Beck, Ph.D., D.A.B.T.®, Deputy Assistant Administrator, U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution...
July 2, 2018

NAS Publishes Report on Biodefense in the Age of Synthetic Biology

On June 19, 2018, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a press release announcing the availability of a final report entitled Biodefense in the Age of Synthetic Biology. According to the National Academies, the final report concludes that “[s]ynthetic biology expands the possibilities for creating new weapons — including making existing bacteria and viruses more harmful — while decreasing the time required to...
June 28, 2018

EPA Releases Final Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program.  Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with a deadline of not later than two years after enactment.  Release of the final Strategic Plan occurred on the second anniversary of enactment of...
June 26, 2018

EPA Issues Guidance on Creating Generic Names for Confidential Chemical Substance Identity Reporting under TSCA

Bergeson & Campbell, P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018. Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online.  This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next. On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance...
June 25, 2018

EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) published a prepublication version of the final rule regarding reporting requirements for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where “mercury” is defined as “elemental mercury” and “a mercury compound” (mercury). Section 8(b)(10)(B) of the Toxic Substances Control Act (TSCA), as amended by the Frank...
June 22, 2018

EPA Celebrates Anniversary of Lautenberg Act by Releasing Final CBI Guidance, Animal Testing Strategy, and Final Mercury Reporting Rule

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule. As noted in our June 29, 2016, memorandum, “TSCA Reform: EPA Publishes First Year Implementation Plan,” the Lautenberg Act...
June 21, 2018

EPA Issues Final Guidance on Points to Consider When Preparing TSCA New Chemical Notifications

The U.S. Environmental Protection Agency (EPA) issued on June 20, 2018, guidance intended “to improve transparency with the public and with companies seeking Agency review of their new chemical substances under the Toxic Substances Control Act (TSCA).” EPA states that the guidance, entitled Points to Consider When Preparing TSCA New Chemical Notifications (Points to Consider Guidance), “promotes early engagement and communication, and enhances overall understanding of EPA’s...
June 15, 2018

Recent Federal Developments – June 2018

Lynn L. Bergeson, Richard E. Engler, Ph.D., And Susan M. Kirsch Contribute To ABA SEER’s The Year In Review 2017: Bergeson & Campbell, P.C. (B&C®) is pleased to announce the publication of The Year in Review 2017: Environment, Energy, and Resources Law by the American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER). The Year in Review 2017 provides an annual summary of developments in environmental, energy, and resources law....