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

GMOs and Bioengineered Food – Historical Milestones

From peas to trees.

Scientists wielding high tech tools like garden trowels, watering cans, and fountain pens launched the genetic engineering age, long before the advent of GMOs and bioengineered food.

I wonder what early genetic engineers would think about today’s biotech industry. Would they feel proud or dismayed about how their own contributions to science have led us, in part, to where we are today?

This is the second post in a series of posts aimed at helping you learn about GMOs (genetically modified organisms) and bioengineered food without shocking headlines or industry spin. In the first post, GMOs and Bioengineered Food – What is It? you were introduced to genetic engineering terms and got a glimpse into how it works. This post will cover a bit of background and history. Other posts will address U.S. laws and regulations (including the pending labeling standard) and environmental issues.

For this post, I selected some of the historical milestones that I found particularly interesting (with some emphasis on food) beginning with the man recognized as the “father of modern genetics,” Gregor Mendel. If you are a history buff or just want more history, check out the links in the references and resource sections.

1866 – Dawn of Modern Genetics

Gregor MendelAustrian monk, Gregor Mendel, presented his paper Experiments on Plant Hybridization.

He had discovered that plant and animal offspring inherit traits from their parents via what we now call genes. Mendel accomplished this by growing 28,000 pea plants between 1856 and 1863, observing seven traits for each generation of plants, and painstakingly recording data (by hand). Unfortunately, as often happens with new scientific breakthroughs, the scientific community, mostly ignored his work until decades later, after he had died.1, 2

1868 – What is this Slimy Stuff?

Friedrich Meischer, a trained physician, and researcher was the first person to isolate the substance we now call DNA.

He conducted his experiments using white blood cells from bandages supplied by a nearby hospital. The molecule he identified came from the nucleus of the cell so he called it nuclein. Meischer published his findings in a paper with the catchy title, On the chemical composition of the pus cells. It would take decades before other scientists realized that the substance Meischer discovered is what carries genetic information and for it to be named deoxyribonucleic acid (DNA).3

1952 – It is Confirmed, DNA is Responsible for Inheritance

Alfred Hershey and Martha Chase conducted experiments confirming that DNA is the genetic material responsible for inheritance.

Martha Chase and Alfred Hershey
Martha Chase and Alfred Hershey – Photo Cold Spring Harbor Laboratory Archives

Previously, some scientists had suggested that DNA carried genetic material but many believed that protein in cells was responsible for inheritance.4

1963 – International Food Safety Standards Get Their Start

The Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) began working on the Codex Alimentarius (Latin, meaning food law or code).

Their purpose was to establish voluntary international food standards to address the growing international food trade and to help ensure food safety, quality, and fair trade practices. Now, guidelines related to biotechnology are included in the Codex.5

1970 – One Weed Killer to Rule Them All

A chemist working at Monsanto named John E. Franz discovered that a glyphosate molecule could be used to create a herbicide that would kill virtually any plant it came in contact with.

A few years later, Roundup hit the market.6

1973 – Pick and Choose DNA

Herbert Boyer and Stanley Cohen demonstrated that they were able to cut and splice strands of DNA from one organism to another organism.

Recombinant DNA is the general name for DNA created by combining at least two strands of DNA. Sometimes, it is called chimera DNA because DNA from different species can be combined like a bacteria and a plant.7

1975 – Hold On, Safety First

140 people, mostly biologists, attended a conference on recombinant DNA at Asilomar State Beach in Monterey County, CA.

Maxine Singer, Norton Zinder, Sydney Brenner, and Paul Berg at Asilomar Conference on rDNA in 1975
Maxine Singer, Norton Zinder, Sydney Brenner, and Paul Berg at Asilomar Conference on Recombinant DNA in 1975 – Photo National Academy of Sciences

These experts came together to talk about the potential dangers of biotechnology and to establish guidelines for conducting experiments safely and keeping them contained.8

1980 – You Can Patent Life

The U.S. Supreme Court ruled that Ananda Mohan Chakrabarty, a scientist working for General Electric, could patent a bacterium he had genetically modified to break down crude oil to help mitigate oil spills.

For the purposes of patent law, the fact that this bacterium was a living organism did not make any difference.9

1982 – It All Began with a Drug

Eli Lilly submitted a request for the U.S. Food and Drug Administration (FDA) to approve their new genetically engineered insulin drug called Humulin in May 1982.

Five months later, in October 1982, the FDA made history by becoming the first U.S. regulatory agency to approve a genetically engineered product for human use.10, 11

1990 – Say Cheese

A genetically modified enzyme for making cheese was the first product ever approved by the FDA for human consumption.

The review process took 28 months.12

1992 – Extended Shelf Life Tomato

Calgene’s FLAVR SAVR tomato crossed its first regulatory hurdle when the U.S. Department of Agriculture (USDA) deregulated it meaning Calgene could grow as many FLAVR SAVR tomatoes as the wanted in outdoor fields unrestricted and unregulated.

The FLAVR SAVR tomato had been genetically engineered to improve its shelf life after being picked. It was the first genetically engineered food crop to receive USDA approval.13

1995 – Plants Make Their Own Insecticide

The U.S. Environmental Protection Agency (EPA) got involved in regulating genetically engineered plants when some plants were genetically modified with Bacillus thuringiensis (Bt), a naturally occurring soil bacterium that is toxic to certain insects.

In 1995, the EPA registered the first “Bt plant-incorporated protectants” for use in the United States. This included Bt corn, Bt cotton, and Bt potatoes.14, 15

1996 – Roundup Ready Crops

Roundup Ready Soybeans Logo
Monsanto

A year after the EPA approved the first insecticide-producing crops; the first herbicide-resistant seeds became commercially available.

In 1996, a million acres of Roundup Ready soybeans were grown in the United States. This meant that farmers could spray their crops with Roundup herbicide to kill weeds in their fields without harming their crops.16

1999 – Rice for the Greater Good

Biologists Ingo Potrykus and Peter Beyer unveiled Gold Rice, which they co-invented to produce beta-carotene in hopes of preventing vitamin A deficiency in millions of children in disadvantaged countries.

This scientific breakthrough was the start of a complex and lengthy patent, regulatory, and acceptance journey that continues to this day.17, 18, 19

2003 – International Biosafety Cooperation

On September 11, 2003, after more than a decade of work, The Cartagena Protocol on Biosafety went into force becoming the first international treaty governing the movements from one country to another of living modified organisms (LMOs) that are created through biotechnology.

To date, 172 countries, not including the United States, have ratified the protocol.20

2007 – The Butterfly Seal

Non-GMO Project LogoTwo grocery stores got together to develop their own non-GMO policy and founded the nonprofit Non-GMO Project.

The organization grew and collaborating with FoodChain ID and other stakeholders created a Non-GMO Project Standard and Product Verification Program. Over 43,000 products now display the Non-GMO Project butterfly logo.21

2009 – Pharm Animals

The FDA approved ATryn the first drug produced by a genetically engineered animal, a goat in this case.

ATryn is made from the milk of goats that have been genetically modified to produce a plasma protein for treating blood-clotting disorders. 22

2013 – CRISPR Critters

MIT scientist Feng Zhang published the first method to engineer CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) to edit the genome in mouse and human cells.

Feng Zhang and Patrick Hsu in MIT Lab
Feng Zhang and Patrick Hsu in MIT Lab – Photo Justin Knight

CRISPR is an alternative to other existing genome editing technologies.23, 24

2015 – Did You Know a Fish Gene is a Drug?

On November 24, 2015, the FDA gave the go-ahead to AquaBounty Technologies, Inc. “for an opAFP-GHc2 rDNA construct at the α-locus in the EO-1α lineage triploid, hemizygous, all-female Atlantic salmon (Salmo salar) known as AquAdvantage Salmon,” which grows about twice as fast as a wild salmon.

The FDA regulates genetically engineered animals as veterinary drugs claiming that genes inserted into animals meet the definition of a drug.25, 26

2016 – Put a Label on It

On July 29, 2016, the United States Congress passed the National Bioengineered Food Disclosure Standard (Public Law 114-216) amending the Agricultural Marketing Act of 1946 (7 U.S.C. 1621).

The USDA is finalizing the labeling standard for implementation on January 1, 2020.27

2018 – Bringing Back the American Chestnut Tree

Researchers at State University of New York (SUNY) have been developing a genetically engineered American chestnut tree to combat a fungus blight that has killed billions of American chestnut trees on the east coast of the United States.

Charles Maynard and William Powell with Transgenic American Chestnut Tree Seedling
Charles Maynard and William Powell with a Genetically Engineered American Chestnut Tree Seedling – Photo State University of New York

Their intent is to outcross the genetically engineered trees with wild trees to create a wild version resistant to the blight. SUNY recently published the results of two greenhouse studies that evaluated belowground interactions between the genetically engineered tree and organisms found in their native ecosystems.28, 29, 30

I hope you found at least a few of the above genetic engineering historical milestones interesting and informative. The next post in this series will cover some of United States laws and regulations including the pending bioengineered food-labeling standard.

Featured Image at Top: Fountain Pen Drawing a Line on Paper – Photo Credit iStock/jmimages

Related Posts

References

  1. Gregor Mendel – Wikipedia
  2. Experiments in Plant Hybridization (1865) – by Gregor Mendel, 1866
  3. Friedrich Miescher – Discoverer of DNA – Friedrich Miescher Institute for Biomedical Research
  4. Hershey–Chase Experiment – Wikipedia
  5. Codex Alimentarius: International Food Standards – Food and Agriculture Organization of the United Nations and the World Health Organization
  6. The History of Roundup – Monsanto
  7. Genetic and Genomics Timelines: 1973 – Genome News Network
  8. Asilomar Conference on Recombinant DNA – Wikipedia
  9. Can We Patent Life? – by Michael Specter, The New Yorker, 04/01/13
  10. A New Insulin Give Approval for Use in U.S. – by Lawrence K. Altman, The New York Times, 10/30/18
  11. Celebrating a Milestone: FDA’s Approval of First Genetically-Engineered Product – by Suzanne White Junod, Ph.D., FDA Historian, September-October 2007
  12. FDA Approves Bioengineered Cheese Enzyme – by Malcolm Gladwell, The Washington Post, 03/24/90
  13. Now, We Bring You…the Engineered Tomato – by Donna K. Walters, Los Angeles Times, 10/17/92
  14. EPA’s Regulation of Bacillus thuringiensis (Bt) Crops – U.S. Environmental Protection Agency, May 2002
  15. E.P.A. Approves Three Genetically Altered Crops – by The Associated Press, The New York Times, 04/11/95
  16. Food Fight: GMOs and the Future of the American Diet, by McKay Jenkins, published by Avery, 2017 (p. 58)
  17. Golden Rice Project
  18. Scientist At Work: Ingo Potrykus; Golden Rice in a Grenade-Proof Greenhouse – By Jon Christensen, The New York Times, 11/21/00
  19. Golden Rice meets food safety standards in three global leading regulatory agencies – Press Release, International Rice Research Institute (IRRI), 05/25/18
  20. The Cartagena Protocol on Biosafety – Convention on Biological Diversity, United Nations Environment Programme
  21. Non-GMO Project – History
  22. F.D.A. Approves Drug From Gene-Altered Goats – by Andrew Pollack, The New York Times, 02/06/09
  23. Questions and Answers about CRISPR – Broad Institute (includes a 2-minute video)
  24. CRISPR Timeline – Broad Institute
  25. New Animal Drugs in Genetically Engineered Animals; opAFP-GHc2 Recombinant Deoxyribonucleic Acid Construct – U.S. Federal Register, 11/24/15
  26. Genetically Engineered Salmon Approved for Consumption – by Andrew Pollack, The New York Times, 11/19/15
  27. National Bioengineered Food Disclosure Standard (Public Law 114-216) – United States Congress, 07/29/16
  28. ESF’s American Chestnut Trees Make Return in NY – State University of New York, 05/06/15
  29. SUNY ESF researchers growing 10,000 blight-resistant American chestnut trees – by Katelyn Faubel, State University of New York College of Environmental Science and Forestry, 04/09/18
  30. Transgenic American Chestnuts Do Not Inhibit Germination of Native Seeds or Colonization of Mycorrhizal Fungi – by Andrew E. Newhouse, Allison D. Oakes, Hannah C. Pilkey, Hannah E. Roden, Thomas R. Horton, and William A. Powell WA, Frontiers in Plant Science, 07/19/18

Resources