The regulatory framework for overseeing agricultural products developed using biotechnological processes can involve up to three United States (US) agencies. These are, the US Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).
Each agency has a specific role in assuring the safety of products created using biotechnology. The USDA, specifically the Animal and Plant Health Inspection Service (APHIS), is responsible for products that may pose a risk to plant and animal health, including ensuring that veterinary biologics are safe and effective. The FDA is concerned with food and feed safety, with food safety being shared with the USDA Food Safety and Inspection Service (FSIS). The FDA is also concerned with drug safety. Finally, the EPA regulates biotechnology products that involve pesticides or act as pesticides and some new biotechnology microorganisms.
These agencies have always worked together, to some degree, but this executive order was designed to streamline the process. To achieve this, a single web portal is being created for collating and sharing all biotechnology regulatory information.2 The EPA and FDA have indicated that they welcome a risk-based scientific approach, as modernization was already being considered.3
APHIS has previously required notification and permits for these products – prior to them being planted commercially, field research needed to be performed to ascertain if they might cause harm. In August 2019, the USDA APHIS proposed a regulatory change that effectively limits oversight of genetically engineered and gene edited crops, allowing no oversight for the majority of crops.4 Despite the organization receiving many requests for alterations, the virtually unchanged regulation was finalized on May 18, 2020. Crop developers are now allowed to self-determine if their biotechnological products are regulated, creating a lack of transparency and allowing potential safety issues.5 Additionally, some gene editing practices will not be considered biotechnological changes.
This creates several potential problems for the US farming sector, as other countries employ strict rules regarding GMO food and feed products. While some markets require clear labeling and transparency, others either restrict or prohibit them.6 Controlling non-approved GMO food and feed can be difficult, as demonstrated in the US, where non-approved GMO wheat has been found growing in uncultivated fields.7
A lack of transparency and the risk of having unknown biotechnologically altered food or feed mixed into non-modified products may make US imports less attractive for foreign buyers. The President of the United States acknowledges this difficulty in his executive order, commanding the commission to develop, “an international strategy to remove unjustified trade barriers and expand markets for products of agricultural biotechnology.”
With a global network of experts, dedicated laboratories, and an advanced regulatory database (SGS Digicomply), SGS offers a comprehensive range of services to help operators in the food and feed sector navigate the complex regulations regarding agricultural biotechnology. We offer testing, certification, and traceability services, including laboratory testing capabilities using next generation sequencing. Our solutions let you demonstrate to your clients that your products are safe and comply with national and international regulations.
Global Food Inspection Technical Manager
t: +1 973 461 1493
1 Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products
2 The Unified Website for Biotechnology Regulation
3 FDA, USDA and EPA Announce Joint Platform to Streamline Information about Agricultural Biotechnology Products & Modernizing the Regulatory System for Biotechnology Products
4 Trump Administration’s USDA Limits Oversight of Genetically Engineered and Gene Edited Crops
5 Movement of Certain Genetically Engineered Organisms
6 Foods Produced by Recombinant DNA Techniques & Genetically Modified Organisms
7 USDA Investigates Unapproved GMO Wheat Found in Washington State