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Chloe Marie Research Specialist

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Federal GMO Labeling Legislation

The following materials represent various statutes and regulations that have been enacted or promulgated by the federal government. While the Center makes every effort to update and provide current resources, be aware that statutory and regulatory language is subject to change. As a result, the Center offers no warranty or other guarantee regarding the timeliness or accuracy of the information presented.

The Coordinated Framework for Regulation of Biotechnology

On June 26, 1986, the White House Office of Science and Technology Policy (OSTP) issued the Coordinated Framework for the Regulation of Biotechnology, providing comprehensive guidelines and ensuring that the U.S. Department of Agricultural (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) effectively coordinate and oversee the marketing and safety of agricultural biotechnology products.  

The Coordinated Framework for Regulation of Biotechnology aims to coordinate and harmonize the regulatory regimes of the federal agencies involved in biotechnology products without enacting new laws, leveraging existing statutes to streamline the process. The existing statutes covered within the regulatory framework include: 

  • The Plant Protection Act (7 U.S.C. § 7701 et seq.) 
  • The Animal Health Protection Act (7 U.S.C. § 8301 et seq.) 
  • The Virus-Serum-Toxin Act (21 U.S.C. § 151 et seq.) 
  • The Federal Meat Inspection Act (21 U.S.C. § 601 et seq.) 
  • The Poultry Products Inspection Act (21 U.S.C. § 451 et seq.) 
  • The Egg Products Inspection Act (21 U.S.C. § 1031 et seq.) 
  • The Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) 
  • The Public Health Service Act (42 U.S.C. § 201 et seq.) 
  • The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. § 136 et seq.)  

The Office of Science and Technology Policy (OSTP) issued an update to the 1986 Coordinated Framework on February 27, 1992, outlining a science-based, risk-oriented approach for overseeing the introduction of biotechnology products into the environment.  

On July 2, 2015, the Executive Office of the President (EOP) issued a memorandum titled “Modernizing the Regulatory System for Biotechnology Products.” This memorandum directed the USDA, FDA, and EPA to conduct a thorough review and update of the Coordinated Framework for Regulation of Biotechnology, with a focus on three key aspects:

  • Analyzing the roles and responsibilities of the federal agencies in the biotechnology regulatory process. 
  • Creating a robust long-term strategy to enhance the federal regulatory system’s ability to evaluate risks related to future biotechnology products.
  • Commissioning an external and independent analysis of the future regulatory landscape for biotechnology products. 

On September 16, 2016, the White House released a proposed update to the Coordinated Framework for the Regulation of Biotechnology accompanied by a National Strategy for Modernizing the Regulatory System for Biotechnology Products, outlining forthcoming measures to address new types of products resulting from advances in science and technology within the regulatory system. Additionally, the White House announced the commissioning of a study titled “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System,” conducted by the National Academy of Sciences. 

On January 9, 2017, the White House released the Final Version of the 2017 Update of the Coordinated Framework for the Regulation of Biotechnology, clarifying the existing roles and responsibilities of the key agencies involved in regulating biotechnology products. 

The National Bioengineered Food Disclosure Standard

On July 29, 2016, Congress passed the 2016 Act (P.L. 114-216), amending the Agricultural Marketing Act of 1946 and instructing the U.S. Department of Agriculture (USDA) to establish a mandatory uniform national disclosure standard for foods that are or may be bioengineered.  

 The Act defines bioengineered food as “food that contains genetic material that has been modified through in vitro recombinant DNA techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.”  

On December 21, 2018, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published in the Federal Register a final rule establishing the National Bioengineered Food Disclosure Standard. 

Effective since February 19, 2019, the final rule:  

  • Preempts state and local genetic engineering labeling requirements. 
  • Applies to food manufacturers, importers, and certain retailers involved in packaging and labeling food for retail sale or selling bulk food items. 
  • Exclusions from the rule include restaurants, similar retail food establishments, and small food manufacturers with annual receipts below $2,500,000.  
  • Does not apply to foods regulated under the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), or Egg Product Inspection Act (EPIA), including pork, beef, sheep, goat, catfish, chicken, turkey, domesticated birds, and egg products.  
  • Food derived from animals fed bioengineered feed and food and ingredients certified under the National Organic Program are also exempt from disclosure.  
  • Allows a tolerance level of 5% for “inadvertent” or “technically avoidable” bioengineered substances in each ingredient.

Additional information on the rule can be found in the USDA AMS webinar titled “Overview of the National Bioengineered Food Disclosure Standard” dated February 2019.  

Movement of Certain Genetically Engineered Organisms 

On May 18, 2020, the U.S. Department of Agriculture (USDA) issued a final rule, titled “Movement of Certain Genetically Engineered Organisms”—also known as the SECURE rule—which updated the regulations governing the movement of genetically engineered organisms to reflect advancements in genetic engineering. The rule aims to alleviate the regulatory burden for developers working with organisms that are deemed unlikely to pose risks to plants. The rule became effective on August 17, 2020.