The SECURE Rule: New Regulations for Crop Biotechnology in the United States

摘要

In May 2020, the US Department of Agriculture enacted new regulations to govern genetically engineered organisms. The 2020 Rule focuses on the products of biotechnology and is designed to accommodate future innovation. The Rule defines genetic engineering broadly, but establishes exemptions from regulation, including certain organisms developed with innovative plant breeding techniques such as genome editing. It allows developers to determine that their new organisms are exempt, with a voluntary USDAprocess to confirm the exemption. A new Regulatory Status Review uses scientific risk assessment to determine whether an organism poses a plausible plant pest risk and is therefore subject to regulation. Organisms that pose plant pest risks, products intended for pharmaceutical or industrial use, and certain other GE organisms require permits for interstate movement, import, or release into the environment. The 2020 Rule reduces the regulatory burden for developers whose organisms are unlikely to posea plant pest risk and reserves stricter USDA oversight for organisms that pose risk. Criticisms of the 2020 Rule focus on exemptions and self determination and on the possible impact of the Rule on trade.