On May 14, 2020, APHIS announced the availability of the Final Rule for its biotechnology regulations 7 CFR part 340. The SECURE rule, which stands for Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient, is the first comprehensive revision of APHIS’ biotechnology regulations since they were established in 1987. The revisions enable APHIS to regulate organisms developed using genetic engineering for plant pest risk with greater precision and reduces regulatory burden for developers of organisms that are unlikely to pose plant pest risks. The SECURE Rule was published in the Federal Register on May 18, 2020.
WHY DOES APHIS REGULATE ORGANISMS DEVELOPED USING GENETIC ENGINEERING?
PLANT PEST RISK DEFINED
Like the preexisting regulations, APHIS’ SECURE rule regulates the importation, interstate movement, and environmental release of certain organisms developed using genetic engineering that may pose a pest risk to plants. The SECURE rule revises the preexisting regulations to account for advances in genetic engineering and our understanding of the plant pest risk posed by organisms developed using genetic engineering.
APHIS’ rule was final when it published in the Federal Register on May 18, 2020. The new rule’s provisions take effect on key dates through October 1, 2021.
The SECURE rule represents a new approach for regulating organisms developed using genetic engineering. It establishes a clear, consistent, and risk-based regulatory framework for products developed using genetic engineering that provides regulatory relief and better focuses regulatory resources on potential areas of risk.
Our years of experience have increased our understanding of the science of biotechnology and the potential risks of biotechnology products to plant health. Under the revised regulation, the biotechnology community can expect reduced regulatory burden and processes that allow us to more efficiently and effectively protect agriculture and foster technological advancement. The biotechnology community will have to learn some new processes and meet new requirements in accordance with the implementation schedule. We are available to support you through this process. It is our goal to minimize regulatory burden and help you comply with our regulations.
Consumers and the public can expect to see us continue to regulate organisms developed using genetic engineering in a manner that protects plant health and U.S. agriculture. We will continue to support all forms of agriculture—conventional, organic, and products improved through biotechnology—to be sure we can help fulfill food security, improve resource use, and meet other important needs of the 21st century for our Nation and for the world.