March 19, 2021

House Subcommittee Holds Hearing on “Brain Drain: Rebuilding the Federal Scientific Workforce

The House Science, Space, and Technology Subcommittee on Investigations and Oversight held a hearing on March 17, 2021, on “Brain Drain:  Rebuilding the Federal Scientific Workforce.”  The Subcommittee heard from the following witnesses: Ms. Candice Wright, Acting Director, Science, Technology Assessment, and Analytics, U.S. Government Accountability Office (GAO);  Mr. Max Stier, President and Chief Executive Officer (CEO), Partnership for Public Service;  Dr. Andrew...
March 19, 2021

Petition Filed in D.C. Appellate Court Seeking Review of EPA’s Conditional Registration of Aldicarb for Use on Oranges and Grapefruit in Florida

On March 3, 2021, the Farmworker Association of Florida, Environmental Working Group, and Center for Biological Diversity petitioned the U.S. Court of Appeals for the District of Columbia Circuit for review of the U.S. Environmental Protection Agency’s (EPA) order registering the use of the pesticide aldicarb on oranges and grapefruit in Florida as set forth in: EPA’s January 12, 2021, “Registration Decision for the Uses on Oranges and Grapefruit in Florida, Aldicarb”;...
March 18, 2021

Is Everything Carcinogenic? — A Conversation with Jane S. Vergnes, Ph.D. and Richard E. Engler, Ph.D.

This week, I sat down with Dr. Jane Vergnes, Director of Toxicology and Vice President, Scientific Affairs, here at B&C and its consulting affiliate, The Acta Group (Acta®), and Dr. Richard Engler, Director of Chemistry, at B&C and Acta.  We discussed the provocative question “is everything carcinogenic?”  In asking this question, Jane and Rich discuss the marketing and labeling implications of a cancer classification for a chemical substance found as an...
March 18, 2021

EPA Announces Settlement Resolving Alleged TSCA Reporting Violations

The U.S. Environmental Protection Agency (EPA) announced on March 15, 2021, a settlement requiring Western Reserve Chemical Corp. (WRCC) in Stow, Ohio, to pay a $357,000 civil penalty for violations of chemical data reporting regulations under the Toxic Substances Control Act (TSCA).  EPA claims that from 2012 to 2015, WRCC failed to submit data reports for 18 chemical substances as required by TSCA.  According to EPA, WRCC imports various chemicals for businesses that formulate rubber,...
March 18, 2021

Gov4Nano Conducting “Data Sharing and FAIR Data Use Survey”

Gov4Nano is a Horizon 2020 project that aims to design an effective risk governance process for nanotechnologies, including improving the availability of nano-relevant data.  To meet its aims, Gov4Nano is conducting a “Data Sharing and FAIR Data Use Survey” to obtain views and opinions from data users and producers on data availability and sharing and how these can be improved.  Gov4Nano seeks to determine how barriers to data availability can be lowered and incentives for data...
March 17, 2021

Comments on Final PBT Rules Due May 17, 2021

As reported in our March 9, 2021, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  On March 16, 2021, EPA announced that comments on the final rules are...
March 17, 2021

Lynn L. Bergeson, “The importance of regulatory diligence in funding,” Financier Worldwide, April 2021.

Lawyers counselling companies in the biotechnology, biopesticide and related crop protection and industrial biotechnology areas appreciate the critically important role federal agencies play in ensuring the success of start-up businesses. Federal agencies, including the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA), among others, wield enormous power over businesses that require premarket product approval. While we product approval practitioners know...
March 16, 2021

EFSA Begins Public Consultation on Draft Updated Guidance on Assessing the Exposure of Operators, Workers, Residents, and Bystanders in Risk Assessment for Plant Protection Products

The European Food Safety Authority (EFSA) announced on March 15, 2021, that it has begun a public consultation on a draft updated Guidance on the assessment of exposure of operators, workers, residents, and bystanders in risk assessment for plant protection products (PPP).  According to EFSA, the Guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of the regulatory risk assessment for PPPs.  The Guidance is based on...
March 15, 2021

Canada Adjusts Fees for New Substance Notifications Effective April 1, 2021

Under Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers).  The amount of the fee is dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted, and other services being requested (e.g., confidential search on the Domestic Substances List (DSL) or Non-Domestic Substances List (NDSL) or masked name...
March 14, 2021

Lynn L. Bergeson, “Better Understand TSCA’s Long Reach,” Chemical Processing, March 14, 2021.

If anyone on planet Earth thinks the Toxic Substances Control Act (TSCA), as amended, is not commercially consequential, think again. The implementation of the 2016 amendments by the U.S. Environmental Protection Agency (EPA) is triggering tremendous commercial disruption. The EPA’s March 8, 2021, announcement seeking comment on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, and, importantly, granting a rare “No Action Assurance”...