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,...
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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...
June 14, 2019
APHIS Proposes Revised Regulatory Framework Regarding The Movement Of Certain Genetically Engineered
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’...
April 19, 2019
USDA APHIS Reopens Public Comment Period On The dEIS And PRA
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...