Archives

January 3, 2024

APHIS Reopens Comment Period on Proposed Additional Exemptions for Plants Modified or Produced Through Genetic Engineering

As reported in our November 16, 2023, blog item, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) proposed on November 15, 2023, five new types of genetic modifications a plant can contain and be exempt from the regulations for the movement of organisms modified or produced through genetic engineering because such modifications could otherwise be achieved through conventional breeding methods. 88 Fed. Reg. 78285. Comments were due December 15,...
November 16, 2023

APHIS Proposes Five Additional Exemptions for Plants Modified or Produced Through Genetic Engineering

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) proposed on November 15, 2023, five new types of genetic modifications a plant can contain and be exempt from the regulations for the movement of organisms modified or produced through genetic engineering because such modifications could otherwise be achieved through conventional breeding methods. 88 Fed. Reg. 78285. According to APHIS’s November 14, 2023, press release, the proposed exemptions...
October 20, 2023

APHIS Releases Revised Draft and Response to Comments on Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering

On October 13, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of a revised draft of the Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering under 7 CFR Part 340 and a Response to Comments on the first draft of the Guide, published on March 23, 2023. APHIS’s Biotechnology Regulatory Services (BRS) received comments on a range of issues and grouped the comments...
August 23, 2023

CRS Updates Report on USDA’s SECURE Rule to Regulate Agricultural Biotechnology

The Congressional Research Service (CRS) published an updated report on August 4, 2023, on the U.S. Department of Agriculture’s (USDA) Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. The revisions note that USDA’s Animal and Plant Health Inspection Service’s (APHIS) five-year Strategic Plan for fiscal years (FY) 2023-2027 states that “one of its objectives is to ensure the safe development of agricultural biotechnology products using a...
July 31, 2023

APHIS 2022 Impact Report Includes Summary of Biotechnology Activities

By Lynn L. Bergeson and Carla N. Hutton   On July 12, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the release of its 2022 impact report. The 2022 impact report lists the following biotechnology activities: Fully implemented USDA’s revised biotechnology regulations, which allow APHIS to focus oversight on products that may pose a risk and reduce regulatory burden for developers of organisms that are unlikely to...
July 11, 2023

USDA Reviews Soybean, Tomato, and Potato Plants Modified Using Genetic Engineering

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 June 27, 2023, that it recently reviewed soybean, tomato, and potato plants modified using genetic engineering. APHIS reviewed the plants to determine whether they presented an increased plant pest risk compared to similar cultivated soybean, tomato, and potato plants: InnerPlant modified two soybean plants and one tomato plant to...
May 3, 2023

APHIS Releases New Strategic Plan for 2023-2027, Includes Biotechnology Objectives

By Lynn L. Bergeson and Carla N. Hutton   On April 25, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it published a new five-year strategic plan. According to APHIS, it incorporates input it received from stakeholders on the strategic framework, a summarized version of the plan that it published in June 2022. The plan includes six strategic goals that focus on working to: Protect agriculture from...
April 12, 2023

APHIS Seeks Comment on Draft Environmental Documents for Deregulation of Corn Developed Using Geneti

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 April 10, 2023, that it is inviting public comment on a draft Environmental Assessment (EA) and draft Plant Pest Risk Assessment (PPRA). 88 Fed. Reg. 21602. APHIS states that it produced these documents in response to a petition from Pioneer Hi-Bred International, Inc. seeking deregulation of a corn variety developed using...
March 23, 2023

APHIS Accepting Public Comments on Draft Guide for Submitting Permit Applications for Microorganisms Developed using Genetic Engineering

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 23, 2023, the availability of a draft guide detailing the information requirements and process for submitting permit applications for microorganisms developed using genetic engineering. The draft Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering under 7 CFR Part 340 is intended to assist developers with preparing a...
March 23, 2023

APHIS Accepting Public Comments on Draft Guide for Submitting Permit Applications for Microorganisms

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 March 23, 2023, the availability of a draft guide detailing the information requirements and process for submitting permit applications for microorganisms developed using genetic engineering. The draft Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering under 7 CFR Part 340 is intended to...
January 9, 2023

APHIS Announces Final Regulatory Status Review Guide

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 plant developed using genetic engineering that APHIS has not...
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...
October 7, 2022

APHIS BRS Will Hold Annual Stakeholder Meeting on December 8, 2022

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) will hold its annual Stakeholder Meeting on December 8, 2022. BRS will offer in-person, at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland 20737, and virtual options for attendance. Attendees will hear updates about BRS’s implementation of the revised biotechnology regulations,...
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...
August 31, 2021

APHIS Announces Draft Regulatory Status Review Guide Available for Public Comment

On August 25, 2021, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its release of a draft guide detailing the information requirements and process for submitting a Regulatory Status Review (RSR) request. Developers of certain genetically modified organisms may use the RSR process to determine the regulatory status of the organisms. The draft guide is open for public comment for 60 days. APHIS also will host a webinar to...
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...