Except for the 2016 bioengineered (BE) food labeling law, the U.S. has no federal laws specific to GMOs (genetically modified organisms) or biotechnology.
However, that does not mean that there is no regulation of the biotech industry or the products they create.
In the United States, three federal agencies, the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and Department of Agriculture (USDA), are largely responsible for ensuring that bioengineered food, drugs, plants, animals, and other products are safe for people, agriculture, and the environment.
This post will give you an overview of some of the U.S. laws that are used to regulate bioengineered food (including the pending labeling standard) and provide links to resources so you can learn more if you want to.
This is the third post in a series of posts about GMOs and bioengineered food. The first two posts, GMOs and Bioengineered Food – What is It? and GMOs and Bioengineered Food – Historical Milestones, introduced you to genetic engineering and provided a historical framework. The last post will look at potential environmental issues.
How Does the Federal Government Regulate GMOs and Bioengineered Food?
When Congress enacts a law, they state what they want to be accomplished (either broadly or in detail) and they grant authority to one or more federal agencies to carry out the law.
In turn, the federal agency or agencies charged with implementing the law establish policies and issue formal regulations through what is called the rulemaking process, which includes informing the public via the Federal Register and allowing public comment at various points in the process.
Before we talk about laws and regulations, it might be helpful to understand a little bit about how the EPA, FDA, and USDA coordinate their regulatory activities.
Coordinated Framework for the Regulation of Biotechnology
During the 1970s and early 1980s, the regulatory arena for biotech products was chaotic with federal agencies acting inconsistently, overriding each other, and approving products without following existing laws.
This exacerbated fears the public was already voicing about the safety and ethics of genetic engineering technologies and products as well as worries about the impact they might have on society and the environment. Many scientists shared these concerns advocating for caution and research safety standards. Companies trying to get approval to conduct field tests outside of their controlled laboratories or to bring products to market were frustrated by the confusing and inconsistent regulatory process.
Although Congress held hearings and considered enacting biotechnology-specific legislation, they failed to do so.
President Ronald Reagan was not a fan of regulatory controls, but in 1984, he allowed the White House Office of Science and Technology Policy to form a working group to develop a coordinated system for regulating biotechnology using existing laws.
When the Coordinated Framework for the Regulation of Biotechnology was issued on June 26, 1986, it contained a matrix showing which agency was responsible for regulating what and policy statements from the EPA, FDA, and USDA describing how each agency regulates products of biotechnology.
Until 2017, the Framework had only been updated once, in 1992, to reaffirm that federal oversight “focuses on the characteristics of the biotechnology product and the environment into which it is being introduced, not the process by which the product is created.”1
In July 2015, the Obama administration issued a memorandum to the EPA, FDA, and USDA directing the agencies to update the Framework, develop a long-term strategy, and commission an independent report, which they did.
- The National Strategy for Modernizing the Regulatory System for Biotechnology Products published in September 2016 describes the federal government’s long-term strategy for ensuring the regulatory system is equipped to assess future risks.
- The January 4, 2017 release of the updated Coordinated Framework for the Regulation of Biotechnology includes the agency’s current roles and responsibilities, methods for coordinating activities and sharing information, and several case studies that outline the regulatory process for various hypothetical genetically engineered products like a plum with pesticide properties or algae for biofuel.
- The National Academy of Sciences published their report entitled Preparing for Future Products of Biotechnology on June 28, 2017. The 212-page report is worth reading; however, this excerpt from page 10 sums it up nicely.2
“The pipeline of biotechnology products likely to emerge over the next decade probably will result in disruptive innovations and significant societal impacts; a carefully balanced, coordinated approach toward future biotechnology products that incorporates input from stakeholders—including interested and affected parties, relevant federal agencies, and nontraditional product developers—will be required.”
Overview of Laws for Regulating Bioengineered Food
In general, the EPA, FDA, and USDA are each responsible for regulating the aspects of biotechnology products that fall under their area of responsibility and authority to ensure bioengineered food and other products are safe for human health and the environment (EPA), safe for people to eat and drink (FDA), and safe to grow in agricultural settings and forests (USDA).
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
The EPA uses a registration process to regulate the sale, distribution, and use of all pesticides including what are called plant-incorporated protectants, which are genetically engineered plants that produce their own pesticides. Registered pesticides must be reviewed at least every 15 years.
A pesticide may be registered if it will generally not cause, “(1) any unreasonable adverse effects to man or the environment taking into account the economic, social and environmental costs and benefits of the use of a pesticide, or (2) a human dietary risk from residues that result from the use of a pesticide in or on any food.”3
The FIFRA also gives the EPA authority to require permits for companies wanting to test their products on more than 10 acres of land or one surface acre of water. Smaller scale experiments do not require permits.
Toxic Substances Control Act (TSCA)
The EPA is required to conduct a pre-manufacturing review of all new chemical substances to prevent their manufacturing, processing, distribution, use, or disposal from presenting an unreasonable risk to people and the environment.
In 2016, the TSCA was amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which added a new requirement. Now, the EPA is required to determine that new chemical substances are safe before they go on the market.
The TSCA excludes food, food additives, drugs, cosmetics, medical devices, pesticides (but not pesticide intermediates), tobacco, nuclear materials, and firearms from EPA jurisdiction because they are covered by other laws.
Federal Food, Drug and Cosmetic (FD&C) Act
The FDA regulates a wide variety of products under the FD&C Act, including human and animal foods, dietary supplements, cosmetics, human and veterinary drugs, human biological products, and medical devices.
Under the FD&C Act, a substance (which could be a GMO) that is intentionally added to food is considered a food additive. Unless the substance is generally recognized as safe (GRAS) for its intended use, it requires premarket approval from the FDA, which offers a voluntary consultation process to help address safety and regulatory issues during early stages of product development.
Genetically engineered animals are regulated by the FDA under the “new animal drug” provision of the law, which makes it illegal to introduce a new animal drug into the market without FDA approval. So-called new animal drugs include animals genetically engineered to produce pharmaceuticals for human use (e.g. insulin) or food for human consumption (e.g. salmon).
The FD&C Act gives the EPA authority to set tolerances for pesticide residues on food for people and animals.
Protection and Inspection Acts
The Animal Health Protection Act, Plant Protection Act, and Virus-Serum-Toxin Act give the USDA regulatory oversight over products that are pests or could cause disease in livestock animals, are deemed plant pests or noxious weeds, or are veterinary biological products used to prevent, diagnose, and treat animal diseases.
If the USDA conducts a risk assessment and determines that a GMO is unlikely to pose a plant pest risk, then it is no longer subject to provisions of the Plant Protection Act, although it might be subject to other regulations.
The Federal Meat Inspection Act, Poultry Products Inspection Act, and Egg Products Inspection Act give the USDA authority and responsibility for ensuring that the United States’ commercial supply of meat, poultry, egg products, and certain farm-raised fish, in interstate commerce, is safe, wholesome, and correctly labeled.
The FDA oversees the safety of substances added to meat, poultry, and egg products under the FD&C Act, while the USDA considers whether the use of such substances is suitable under the various Inspection Acts.
National Environmental Policy Act (NEPA)
NEPA, passed by Congress in 1969, requires all branches of the federal government to consider the environment prior to undertaking any major federal action that significantly affects the environment. Each agency has its own guidelines about what constitutes a major federal action, which could be approving a bioengineered food or other product.
National Bioengineered Food Disclosure Standard (NBFDS)
President Obama signed the National Bioengineered Food Disclosure Standard (public law 114-216) on July 29, 2016.
- Provides a definition of bioengineering as it relates to food.
- Requires the Secretary of Agriculture to establish a national mandatory bioengineered (BE) Food disclosure standard.
- Pertains only to food and drink for human consumption.
- Pertains only to food and drink that already requires labeling by either the FDA or USDA.
- Prohibits food products from animals being considered BE just because they eat BE food themselves.
- Prohibits any state from establishing their own BE food labeling standards and overturns state laws previously passed (e.g. Vermont).
- Exempts food served in restaurants and food manufacturers with less than $2.5M in annual revenue.
National Bioengineered Food Disclosure Standard Proposed Rule
The USDA published their NBFDS proposed rule (regulation) on May 4, 2018, and allowed the public to comment until July 3, 2018.
Notable features of the proposed rule are:
- The percentage and predominance of BE ingredients will be used to determine whether a food requires BE disclosure or not.
- Only foods on a list created by the USDA will be subject to disclosure. The proposed list includes canola, corn, soybeans, cotton, sugar beets, non-browning apples, papaya, potatoes, and some squashes. The list will be updated annually.
- Highly refined ingredients like oil and sugar produced from BE plants such as corn and sugar beets may end up being excluded from disclosure.
- There are three options for BE food disclosure on food and packaging: text stating the food is BE or may contain BE ingredients, a symbol, or an electronic or digital link you scan with your smartphone (if you have one) to go to a website for more information.
- Although failing to make a BE food disclosure is prohibited, Congress did not authorize the USDA to enforce the law other than to conduct audits and hearings. There is no provision for penalties for non-compliance.
- Manufacturers have until January 1, 2022, to comply with the law.
After reading this post, I hope you feel at least a little informed about how the EPA, FDA, and USDA regulate bioengineered food. In the next and final post of this series, we will look at environmental issues and concerns.
Featured Image at Top: Meshed Gears that Say Rules, Regulations, Compliance, Policies, and Standards – Photo Credit iStock/EtiAmmos
- Environmental Impact of Eating Meat
- GMOs and Bioengineered Food – What is It?
- GMOs and Bioengineered Food – Historical Milestones
- GMOs and Bioengineered Food – Pesticide Proliferation
- Organic Food – Healthy Soil is Good for the Environment
- Organic Food – History
- Organic Food – USDA National Organic Program
- Organic Food – USDA Rules and Regulations
- Organic Food – What Does the USDA Organic Label Mean?
- Vat Meat, Cultured Meat, In Vitro Meat – Would You Eat It?
- 2017 Coordinated Framework for Biotechnology Products –White House OSTP, 01/04/17 (p. 4)
- Preparing for Future Products of Biotechnology – U.S. National Academies of Sciences, Engineering, and Medicine, 2017 (p. 10)
- Summary of the Federal Insecticide, Fungicide, and Rodenticide Act – U.S. Environmental Protection Agency
- 1986 Coordinated Framework for Biotechnology Products – White House OSTP, 06/26/86
- 2017 Coordinated Framework for Biotechnology Products –White House OSTP, 01/04/17
- Agricultural Biotechnology – U.S. Department of Agriculture
- Agricultural Biotechnology: Background, Regulation, and Policy Issues – by Tadlock Cowan, Congressional Research Service, 07/20/15
- BE Disclosure & Labeling – U.S. Department of Agriculture, Agricultural Marketing Service
- Biotechnology Guidance Documents & Regulatory Information – U.S. Food and Drug Administration
- EPA’s Regulation of Biotechnology for Use in Pest Management – U.S. Environmental Protection Agency
- FDA Has Determined That the AquAdvantage Salmon is as Safe to Eat as Non-GE Salmon – Press Release, U.S. Food and Drug Administration, 11/19/15
- Federal Food, Drug and Cosmetic (FD&C) Act – Wikipedia
- Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) – Wikipedia
- Food from Genetically Engineered Plants – U.S. Food and Drug Administration
- Frank R. Lautenberg Chemical Safety for the 21st Century Act – Wikipedia
- Genetically Engineered Salmon – by Harold F. Upton and Tadlock Cowan, Congressional Research Service, 12/08/15
- Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System – White House press release, 01/04/17
- Keeping Consumers in the Dark: How the National Bioengineered Food Disclosure Standard Threatens Transparency and Food Security – by Robin M. Nagele, Jurimetrics, 07/12/17
- Memorandum for Heads of Food and Drug Administration, Environmental Protection Agency, and Department of Agriculture – White House OSTP, 07/02/15
- National Bioengineered Food Disclosure Standard (public law 114-216) – U.S. Government Printing Office, 07/29/16
- National Bioengineered Food Disclosure Standard Proposed Rule – U.S. Federal Register, 05/04/18
- National Environmental Policy Act – Wikipedia
- National Strategy for Modernizing the Regulatory System for Biotechnology Products – White House OSTP, September 2016
- Policy: Reboot the debate on genetic engineering – by Jennifer Kuzma, Nature, 03/09/16
- Preparing for Future Products of Biotechnology – U.S. National Academies of Sciences, Engineering, and Medicine, 2017
- Public Interest Advocacy Group Sues Trump Administration Over Unlawfully Keeping GMO Labeling Documents Secret – Press Release, Center for Food Safety, 07/11/18
- Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture – by Emily Marden, Boston College Review, Volume 44, 2003
- Secretary Perdue Issues USDA Statement on Plant Breeding Innovation – Press Release, U.S. Department of Agriculture, 03/38/18
- Study of Electronic or Digital Link Disclosure: A Third-Party Evaluation of Challenges Impacting Access to Bioengineered Food Disclosure – by Deloitte, July 2017 on behalf of U.S. Department of Agriculture
- The U.S. Regulations for Biotechnology Are Woefully Out of Date – by Brooke Borel, Slate, 04/21/17
- Toxic Substances Control Act (TSCA) – Wikipedia
- Updating Biotechnology Regulations – Press Release, U.S. Department of Agriculture, 06/29/18
- Who Approved the Genetically Engineered Foods Coming to Your Plate? No One. – by Mike Orcutt, MIT Technology Review, 04/21/16