Archives

January 9, 2023

APHIS Announces Final Regulatory Status Review Guide

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced on December 22, 2022, that it posted its final Regulatory Status Review (RSR) guide. The RSR guide details the information requirements and process for submitting an RSR request under the revised biotechnology regulations at 7 C.F.R. Part 340. Under the revised regulations, developers may request a permit and/or an RSR of a...
October 24, 2022

APHIS Issues RSR Responses under Revised Biotechnology Regulations for Modified Corn and Potato Plan

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on October 21, 2022, that it recently reviewed a corn plant and a potato plant that were modified using genetic engineering to determine whether they present an increased pest risk as compared to unmodified plants. APHIS has posted its Regulatory Status Review (RSR) responses on its website, as required under 7 C.F.R....
October 11, 2022

APHIS Issues RSR Responses under Revised Biotechnology Regulations

By Lynn L. Bergeson and Carla N. Hutton   On September 7, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it reviewed a new tomato from Norfolk Plant Sciences. The tomato was modified to alter its color and enhance its nutritional quality. APHIS found the plant is unlikely to pose an increased plant pest risk compared to other cultivated tomatoes and is not subject to regulation under...
September 1, 2022

USDA’s APHIS Announces New Microbes Q&A and Updated Confirmation Request Guidance

On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS...
September 1, 2022

USDA’s APHIS Announces New Microbes Q&A and Updated Confirmation Request Guidance

 On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS...
September 1, 2022

USDA’s APHIS Announces New Microbes Q&A and Updated Confirmation Request Guidance

By Lynn L. Bergeson and Carla N. Hutton   On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: “Questions & Answers — Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover...
May 22, 2020

Final SECURE Rule Will Update And Modernize USDA’s Biotechnology Regulations

By Lynn L. Bergeson On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and...
April 17, 2020

USDA Report States That Brexit Will Not Change Policies Affecting GE Plants

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 9, 2020, the U.S. Department of Agriculture (USDA) published a report titled “Agricultural Biotechnology Annual,” which argues that under any scenario, the United Kingdom’s (U.K.) separation from the EU (Brexit) is unlikely to change policy or trade in genetically engineered (GE) industries. According to the report prepared by USDA’s Jennifer Wilson, given the fact that the EU is the U.K.’s trading partner...
March 6, 2020

FDA Announces Educational Initiative To Inform Consumers Of GE Foods

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 4, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with EPA and the U.S. Department of Agriculture (USDA), launched a new initiative called “Feed Your Mind” to help consumers better understand genetically engineered (GE) foods. Consisting of science-based information, the initiative’s features include a wide range of resources designed to teach consumers, health care professionals, and students...
September 6, 2019

ELI To Host Webinar On Genetic Engineering

On September 11, 2019, from 12:00 p.m. to 1:30 p.m. (EDT), the Environmental Law Institute (ELI) will host a webinar titled “Genetic Engineering: The Good, The Bad, and The Necessary.” The webinar is designed to cover the vast possibilities offered by genetic engineering in a world where regulatory officials face increasing pressure to guarantee global food security. Along with the many possibilities associated with genetic engineering, however, there are great concerns about the...