All Knowledge & Insights By Date

By Lynn L. Bergeson and Carla N. Hutton   President Joseph Biden’s September 12, 2022, Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative directs the U.S. Department of Commerce’s (DOC) Bureau of Economic Analysis (BEA) to assess “the feasibility, scope, and costs of developing a national measurement of the economic contributions of the bioeconomy.” As reported in our March 30, 2023, blog item, BEA released a March 2023 report on...

On April 4, 2023, Bloomberg Law quoted Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), regarding the U.S. Environmental Protection Agency's (EPA) process for reviewing new chemicals. Chemical manufacturers should anticipate the EPA’s reviews of new chemicals to take a year or more, not the 90-180 days mandated by the law, said Richard Engler, director of chemistry at Bergeson & Campbell, P.C. Yet “the agency is improving,” he said. TSCA...

The U.S. Environmental Protection Agency (EPA) will hold training on May 23, 2023, on Generalized Read-Across (GenRA), a publicly available tool that uses an automated approach to make reproducible read-across predictions of toxicity. EPA states that read-across “is a commonly used data gap filling technique whereby endpoint information for one substance is used to predict the same endpoint for another substance, supported by structural or other feature similarities.” According to EPA,...

By Lynn L. Bergeson and Carla N. Hutton   As part of the National Biotechnology and Biomanufacturing Initiative, the U.S. Department of Defense (DOD) announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. As reported in our March 30, 2023, blog item, on March 22, 2023, DOD released its Biomanufacturing Strategy to guide these...

On March 29, 2023, the Internal Revenue Service (IRS) published a notice of proposed rulemaking (NPRM) relating to the Superfund excise taxes imposed on certain chemicals and certain imported substances, effective July 1, 2022. 88 Fed. Reg. 18446. There are two separate Superfund chemical excise taxes: a tax on the sale or use of “taxable chemicals” and a tax on the sale or use of imported “taxable substances.” The NPRM contains proposed regulations under Sections 4661, 4662, 4671,...

The U.S. Environmental Protection Agency (EPA) announced on March 23, 2023, that it is seeking public nominations of scientific and technical experts that EPA can consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of the “2023 Draft Supplement to the 1,4-Dioxane Risk Evaluation.” 88 Fed. Reg. 17566. EPA states that it will release the draft supplement for public review and comment in June 2023. EPA also plans to...

By Lynn L. Bergeson and Carla N. Hutton As reported in our March 30, 2023, blog item, on March 22, 2023, the White House Office of Science and Technology Policy (OSTP) released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals. The report includes five sections, each presenting goals that highlight what could be possible with the power of biology. The goals set ambitious national targets for the next two decades to...

WEBINAR -- TOP TSCA TOPICS: Cumulative Risk, NAMs, Risk Evaluations, CBI, And More!, May 17, 2023, 11:00 a.m. – 12:00 p.m. (EDT), Via Webinar: Panelists Anna Lowit, Senior Science Advisor, Office of Pollution Prevention and Toxics (OPPT), and Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will discuss New Approach Methodologies (NAM), cumulative risk assessment methodologies, systematic review procedures, new approaches to new chemical...

Bergeson & Campbell, P.C.’s (B&C®) March 22, 2023, webinar, “Extended Producer Responsibility (EPR) Regulations,” is now available for on-demand viewing. During this one-hour webinar LeRoy (Lee) C. Paddock, Distinguished Professorial Lecturer of Environmental Law at the George Washington University Law School; Edith G. Nagy, Regulatory Consultant, B&C; and Lynn L. Bergeson, Managing Partner, B&C, discuss the history and evolution of EPR legislation,...