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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...

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...

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...

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...

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....

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...

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,...

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...

 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...

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...

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...

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...

By Lynn L. Bergeson The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a proposed rule on June 6, 2019, on the movement of certain genetically engineered (GE) organisms.  84 Fed. Reg. 26514.  The proposed rule would revise the regulations regarding the movement, including the importation, interstate movement, and environmental release of certain GE organisms in response to advances in genetic engineering and APHIS’...

By Lynn L. Bergeson On April 12, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the reopening of the public review and comment period for the draft Environmental Impact Statement (dEIS) and the preliminary Pest Risk Assessment (PRA). These two documents have been prepared in response to a permit application from a company requesting the environmental release of genetically engineered (GE) Citrus tristeza virus (CTV). The...

By Lynn L. Bergeson On April 3, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced a request for comments on two documents related to the potential deregulation of a canola variety genetically engineered (GE) to convert oleic acid to docosahexaenoic acid (DHA) and eicosapentaeonic acid (EPA), as well as for resistance to an imidazolinone herbicide. The documents are a draft Environmental Assessment (dEA) and a draft Plant Pest...

By Lynn L. Bergeson On March 19, 2019, USDA’s Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) announced the delay of the spring release for BRS’ updated permitting system in APHIS eFile.  The release is now expected to occur in mid-summer 2019, with periodic updates provided by APHIS BRS as the anticipated release approaches.  In its announcement, APHIS BRS highlighted its commitment to bringing a permitting system that takes...

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) signaled on June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.”  The EIS will have a significant impact on how APHIS chooses to amend its regulation of GE...

By Lynn L. Bergeson and Carla N. Hutton The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) signaled on June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.”  The EIS will have a significant impact on...

By Lynn L. Bergeson On June 26, 2018, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced it was seeking public comment on a draft Environmental Assessment (EA) and a preliminary Plant Pest Risk Assessment (PPRA) prepared in response to a petition from Nuseed Americas Inc. (Nuseed) to deregulate a canola variety genetically engineered to convert oleic acid to docosahexaenoic acid (DHA).  83 Fed. Reg. 29742.  APHIS will...

By Lynn L. Bergeson On May 11, 2018, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of a draft Environmental Impact Statement (EIS) for public review and comment. This document evaluates the possible environmental impacts from a potential approval of a permit to release a genetically engineered (GE) Citrus tristeza virus (CTV) through Florida.  This GE plant virus would be used as a biological control...