GMOs and Bioengineered Food – Laws and Regulations

You have a right to know what is in your food.

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.

Roundup Ready Soybean Field
Roundup Ready Soybean Field – Photo Credit Monsanto

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.

U.S. Office of Science and Technology Policy (OSTP) LogoPresident 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.

  1. 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.
  2. 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.
  3. 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)

U.S. Environmental Protection Agency (EPA) LogoThe 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

U.S. Food and Drug Administration (FDA) LogoThe 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

U.S. Department of Agriculture (USDA) LogoThe 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.

Genetically Engineered AquAdvantage Salmon Compared to Atlantic Salmon
Genetically Engineered AquAdvantage Salmon Compared to Atlantic Salmon of Same Age – Photo Credit AquaBounty

The law:

  • 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.

Cheeseburger with French Fries on Wooden Table
Do this cheeseburger and fries contain GMOs? You may never know. Photo Credit iStock/nitrub

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.
  • Quick Response (QR) CodeThere 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

Related Posts

References

  1. 2017 Coordinated Framework for Biotechnology Products –White House OSTP, 01/04/17 (p. 4)
  2. Preparing for Future Products of Biotechnology – U.S. National Academies of Sciences, Engineering, and Medicine, 2017 (p. 10)
  3. Summary of the Federal Insecticide, Fungicide, and Rodenticide Act – U.S. Environmental Protection Agency

Resources

Find it in the Federal Register – Government Transparency

Information is available at your fingertips.

The Federal Register enables you to learn about proposed regulations and participate in the decision-making process of the U.S. federal government. I like that.

The purpose of the Federal Register is to be a source for and a record of the official actions of the executive branch of the U.S. government. Information is compiled into a consistent format that is published and made available to the public, in print and online, each business day (except federal holidays).

The Federal Register contains executive orders and proclamations issued by the president, rules and regulations that federal agencies are proposing, implementing, or repealing, and public notices about hearings, meetings, and federal grant applications.

After browsing a few issues of the Federal Register, I realized that it offers an early warning system of sorts by providing a heads up on what federal agencies are considering doing before they actually do it (and afterward, too.)

This empowers you and me to get involved early in issues that we care about by writing, calling, or emailing our elected officials, attending public meetings, and/or making public comments on specific items (anonymously if preferred).

Now, I subscribe to the Federal Register and receive a daily summary in my email inbox and you can, too.

In this post, you will have an opportunity to learn a little about the history of the Federal Register and then look at an example from the Friday, April 20, 2018 issue, which prompted this post. Here is a hint. What does the Tax Cuts and Jobs Act of 2017 have to do with opening up the Arctic National Wildlife Refuge for oil and natural gas exploration?

A Brief History of the Federal Register

The Federal Register got its start during the Great Depression of the 1930s.

When Franklin D. Roosevelt became the 32nd president of the United States in 1933, he immediately set about trying to fulfill his campaign promise of creating a New Deal for Americans who were suffering from the worst economic crisis in the country’s history. Between his executive orders and legislation from Congress, there was an onslaught of new programs, rules, and regulations resulting in a mountain of documents.

Back then, everything was printed on paper with little consistency in format and there were limited ways to make the information available to the public and other government agencies leaving many people in the dark. For instance, federal agencies found it difficult to keep track of their own documents and companies complained that they could not comply with regulations that they did not know existed.

Two pieces of legislation made substantial inroads into taming the document chaos and making information more accessible.

The National Archives Act of 1934 created a new agency responsible for taking custody of original federal government documents, archiving them, and making them available for public inspection. Later they were put in charge of publishing the Federal Register in conjunction with the Government Printing Office.

The Federal Register Act of 1935 required that certain documents be printed and distributed in a uniform and timely manner in a new publication called the Federal Register. The documents were to include: presidential proclamations and executive orders; documents the president determined to have general applicability and legal effect; documents required to be published by Act of Congress; and documents authorized to be published by regulations.

Federal Register, Volume 1, No. 1, March 14, 1936
Federal Register, Volume 1, No. 1, March 14, 1936

A feature of the law was that no document could be used against any person unless it had been published in the Federal Register first. That also meant that people could not claim ignorance of rules and regulations anymore.

One way for people to keep current was to pay $10.00 a year for a Federal Register by mail subscription.

The first Federal Register rolled off the printing press on March 14, 1936.

This 16-page publication was mostly taken up by regulations from the Treasury Department pertaining to the newly passed Social Security Act. It also included a presidential executive order with extensive directions about enlarging the Cape Romain Migratory Bird Refuge in South Carolina and a cryptic notice from the Department of Agriculture about a public hearing scheduled to address the regulation of milk handling in St. Louis, Missouri.

Since its inception in 1936, the Federal Register system has expanded and evolved.

In 1937, Congress passed an amendment to the Federal Register Act providing for a codification of regulatory documents resulting in the Code of Federal Regulations that exists today. Regulations in the Code are organized into fifty subject areas called Titles, such as Title 7 – Agriculture, Title 21 – Food and Drugs, and Title 40 – Protection of Environment.

The Administrative Procedure Act of 1946 was important because it made the rulemaking process (creating regulations) more transparent to the public. This law requires federal agencies to publish notices and information in the Federal Register about proposed rulemaking and provide an opportunity for the public to comment before the final rules can be put into effect.

The Federal Register system entered the Internet age in 1992 when the Federal Register became available via an electronic bulletin board. Nowadays, the Federal Register and the Code of Federal Regulations have their own websites and everything is available online as well as in print.

These are just a few of the highlights of the history of the Federal Register. If you are interested in more in-depth information, there are links in the resource section below.

Next is a current example of the Federal Register.

Federal Register, Volume 83, No. 77, April 20, 2018

Earlier in the post, I posed the question, “What does the Tax Cuts and Jobs Act of 2017 have to do with opening up the Arctic National Wildlife Refuge for oil and natural gas exploration?” You may already know the answer. If not, read on.

Arctic National Wildlife Refuge Coastal Plain Looking Toward Brooks Range Mountains - Photo Credit USFWS
Arctic National Wildlife Refuge Coastal Plain Looking Toward Brooks Range Mountains in Alaska – Photo Credit USFWS

You are probably familiar with President Trump’s promise to reduce corporate tax rates in hopes that with more money in their pockets companies will create jobs for Americans. Congress pushed through and passed the Tax Cuts and Jobs Act of 2017 on December 22, 2017, so the president could sign it before Christmas.

Buried on page 182 of the 185-page Tax Act is a prime example of pork barrel politics in action, which is when a completely unrelated item is tacked onto a bill because it would not have had enough support in Congress to pass on its own.

This add-on to the Tax Act makes a small but significant amendment to the Alaska National Interests Lands Conservation Act of 1980, which specifically prohibits the production of oil and gas from the Arctic National Wildlife Refuge (ANWR) unless authorized by an Act of Congress.

The Tax Act provided the necessary Act of Congress and directed the Bureau of Land Management (BLM) to open up the 1.6 million acres of the ANWR known as the Coastal Plain for an oil and natural gas leasing program.

By law, the BLM is required to prepare an Environmental Impact Statement (a report) before they can implement a new oil and gas leasing program. They are also required to inform the public of their intention to do so via the Federal Register and to provide an opportunity for public comment.

Thanks to the early warning provided by the Federal Register, this issue is now on my radar screen. I decided to take advantage of the opportunity to get in on the ground floor so to speak by making a public comment on the website where the BLM is accepting comments. Please consider joining me and making your own comment.

BLM ANWR Coastal Plain Oil and Gas Program EIS Notice Public Comment

After reading this post, I hope you have gained an appreciation for the value of the Federal Register and will take a few minutes to create your own account and subscription. The sign-up link is in the upper right-hand corner of the Federal Register website.

Featured Image at Top: Little Kid Wearing a Pith Helmet Lying in the Grass Looking through Binoculars – Photo Credit iStock/Maartje van Caspel

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Resources