By Lynn L. Bergeson On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s Plant and Animal Biotechnology Innovation Action Plan (Action Plan). Focused on FDA’s risk-based regulatory framework, the Action Plan aims at securing confidence in the safety and performance of plant and animal-based products for consumers,...
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March 29, 2019
FDA’s Premarket Voluntary Plant Biotechnology Consultation Program Provides Opportunity For Develope
By Lynn L. Bergeson In a recent statement prepared by U.S. Food and Drug Administration’s (FDA) Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, and by Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards. Plant biotechnology consists of methods...
November 2, 2018
FDA Releases Statement On A New Plant And Animal Biotechnology Innovation Action Plan
By Lynn L. Bergeson On October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and animal biotechnology innovation. Aimed at ensuring the safety of plant and animal biotechnology products and avoiding unnecessary barriers to future innovation, the Action Plan focuses on three key priorities: Advancing public health by promoting...
By Lynn L. Bergeson On August 2, 2018, the Trump Administration’s Principal Deputy Director of the U.S. Fish and Wildlife Service, Gregory J. Sheehan, reversed an Obama era 2014 policy on the use of biotechnology on wildlife refuges. On July 17, 2014, the Obama Administration issued a memorandum prohibiting the use of genetically modified biotechnology crops to feed wildlife and the use of neonicotinoid pesticides in agricultural practices. This ban was issued in response to...
April 6, 2018
USDA Issues Statement On Plant Breeding Innovation Techniques That Include Genome Editing
By Lynn L. Bergeson On March 28, 2018, Secretary of the U.S. Department of Agriculture (USDA) Sonny Perdue issued a statement providing clarification on USDA’s oversight of plants produced through innovative new breeding techniques that include techniques called genome editing. The announcement states that under its biotechnology regulations, USDA “does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding...
January 19, 2018
Rural Prosperity Task Force Presents Findings To President Trump
By Lauren M. Graham, Ph.D. On January 8, 2018, U.S. Secretary of Agriculture Sonny Perdue presented to President Donald Trump the findings of the Interagency Task Force on Agriculture and Rural Prosperity. The Task Force was established in 2017 following an Executive Order by President Trump to ensure the informed exercise of regulatory authority that impacts agriculture and rural communities. According to the report, over 100 actions organized around five key topic areas,...
By Kathleen M. Roberts On November 8, 2017, the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) issued a statement soliciting applications for its Biotechnology Risk Assessment Research Grants Program. The program aims to support the generation of new information that will assist federal regulatory agencies in making science-based decisions about the effects of introducing genetically engineered (GE) organisms, including microorganisms,...
November 10, 2017
B&C, BCCM Publish Article On Microbial TSCA Compliance
By Lauren M. Graham, Ph.D. Industrial Biotechnology recently published a special issue to highlight the advances and challenges in algae-based products and applications. The article, written by B&C® Consortia Management, L.L.C. (BCCM) affiliate Bergeson & Campbell, P.C. (B&C®) Managing Partner, Lynn L. Bergeson; B&C Senior Chemist, Richard E. Engler, Ph.D.; and BCCM Manager, Lauren M. Graham, Ph.D., examines the complex regulatory domain and discusses the...
October 27, 2017
Congressmen Send Bipartisan Letter On Regulating Agricultural Biotechnology To USDA, FDA, EPA
By Lauren M. Graham, Ph.D. On October 17, 2017, Congressman Jimmy Panetta (D-CA), Congressman Neal Dunn, M.D. (R-FL), and 77 additional House members sent a bipartisan letter to the U.S. Department of Agriculture (USDA), U.S. Food and Drug Administration (FDA), and U.S. Environmental Protection Agency (EPA) to urge the agencies to work together to promote innovative new technologies aimed at increasing crop yields and reducing the cost of production. According to Congressman Panetta,...
October 13, 2017
FDA Announces Meeting, Calls For Comments On FDA/USDA Agricultural Biotechnology Education And Outre
By Lauren M. Graham, Ph.D. On October 12, 2017, the U.S. Food and Drug Administration (FDA) announced two public meetings regarding its Agricultural Biotechnology Education and Outreach Initiative. The meetings will be held in Charlotte, North Carolina, on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California, on November 14, 2017, from 8:00 a.m. to 1:00 p.m. (PST). FDA states the purpose of the public meetings is “to provide the...