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Volume X, Number 264

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Biobased & Renewables Federal News Update - August 7 2020

EPA OIG Finds Safer Choice Program Would Benefit From Formal Goals And Additional Oversight

On June 30, 2020, EPA’s Office of Inspector General (OIG) released a report on its audit to determine whether the Safer Choice program effectively meets its goals and whether the program achieves quality standards through its product qualification, renewal, and required audit processes. OIG states that EPA’s Safer Choice program does not have formal goals included in the FY 2018-2022 EPA Strategic Plan, and the program has not reported results for FYs 2018-2019. The program does have internal, non-outcome-oriented goals, however, which it is generally achieving. The Safer Choice program’s goal is to add 200 Safer Choice products to the program and 25 chemicals to the Safer Chemical Ingredients List each year. According to OIG, in FY 2019, EPA added 265 products and 24 chemicals. OIG states that by not including formal goals for the Safer Choice program in EPA reports while continuing to receive Congressional funding and support, EPA limits not only accountability to Congress and the public, but also the extent that the program can use performance management information to make policy, budget, and management decisions. OIG notes that the Safer Choice program has general controls in place for the required Safer Choice audit process, and EPA reviews audit summaries and corrective actions provided by third-party profilers (TPP). EPA does not routinely review all supporting documentation, however, relying on TPPs to review and retain these documents. Additionally, the Safer Choice program does not have procedures in place to conduct any formal performance reviews of TPPs or oversight reviews of TPP partner audits. According to OIG, without periodic audit oversight, including full reviews of supporting documents and formal performance reviews of TPPs, EPA risks approving products that do not comply with the Safer Choice Standard. OIG recommends that the Assistant Administrator for Chemical Safety and Pollution Prevention develop and publish adequate Safer Choice program goals and performance measures, establish and implement procedures for formal audit oversight of TPPs, amend its memorandums of understanding with TPPs to require performance reviews conducted by EPA, and collect and document TPP audit supporting information.

USDA Requests Comments On Update To Bioengineered Foods List

On July 24, 2020, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) announced its solicitation for comments and feedback on recommendations to update the List of Bioengineered Foods as it pertains to the National Bioengineered Food Disclosure Standard. Comments are due by August 24, 2020.

FDA DHHS Announces 2021 Biosimilar User Fee Rates

On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. The fees assessed are used by FDA for certain activities in connection with biosimilar biological product development, review of applications for approval of biosimilar biological products, and approval of product applications. The established fees will apply from October 1, 2020, through September 30, 2021.

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 220

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

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