9.2: Regulation of Plant GMOs

Food Ingredients

Although the FDA has little regulatory control over food before it goes to the market, what it does have control over is food ingredients, such as food additives. Food additives include intentional components added to food as well as unintentional additives from the manufacturing process.

All food additives are approved before use – a list of approved food additives can be found on the FDA website. Any substance that the FDA considers ‘Generally Recognized as Safe (GRAS)’ does not need to be approved before use. https://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm091048.htm

"GRAS" is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive. https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras

Regulation of Agricultural Biotechnology

FDA regulates the safety of food for humans and animals, including foods produced from genetically engineered (GE) plants. Foods from GE plants must meet the same food safety requirements as foods derived from traditionally bred plants. While genetic engineering is sometimes referred to as “genetic modification” producing “genetically modified organisms (GMOs),” FDA considers “genetic engineering” to be the more precise term. www.fda.gov/food/food-new-plantvarieties/consumer-info-about-food-geneticallyengineered-plants

Figure \(\PageIndex{1}\): Genetically engineered plums to resist plum pox carried by aphids. Image by Agriculture Research Service, public domain.

What are Genetically Engineered (GE) Organisms?

Crop improvement happens all the time, and genetic engineering is just one form of it. We use the term “genetic engineering” to refer to genetic modification practices that utilize modern biotechnology. In this process, scientists make targeted changes to a plant’s genetic makeup to give the plant a new desirable trait. For example, two new apple varieties have been genetically engineered to resist browning associated with cuts and bruises by reducing levels of enzymes that can cause browning.

Humans have been modifying crops for thousands of years through selective breeding. Early farmers developed cross-breeding methods to grow numerous corn varieties with a range of colors, sizes, and uses. For example, the garden strawberries that consumers buy today resulted from a cross between a strawberry species native to North America and a strawberry species native to South America.

Why Genetically Engineer Plants?

Developers genetically engineer plants for many of the same reasons that traditional breeding is used. They may want to create plants with better flavor, higher crop yield (output), greater resistance to insect damage, and immunity to plant diseases. Traditional breeding involves repeatedly cross-pollinating plants until the breeder identifies offspring with the desired combination of traits. The breeding process introduces many genes into the plant. These genes may include the gene responsible for the desired trait, as well as genes responsible for unwanted characteristics. Genetic engineering isolates the gene for the desired trait, adds it to a single plant cell in a laboratory, and generates a new plant from that cell. By narrowing the introduction to only one desired gene from the donor organism, scientists can eliminate unwanted characteristics from the donor’s other genes. Genetic engineering is often used in conjunction with traditional breeding to produce the genetically engineered plant varieties on the market today.

Am I Eating Food from Genetically Engineered Plants?

The planting of genetically engineered (GE) crops was allowed for the first time in the United States in 1995. Today, it is estimated that over 90% of soy, and over 80% of cotton and canola products come from genetically modified crops. Genetically modified crops were created to improve productivity and cut costs by improving insect resistance, virus resistance, herbicide tolerance, and similar issues that affect commercial crops.

The majority of GE plants are used to make ingredients that are used in other food products. Such ingredients include corn starch in soups and sauces, corn syrup used as a sweetener, corn oil, canola oil, and soybean oil in mayonnaise, salad dressings, bread, and snack foods.

Voluntary Pre-Market Engagement for New Plant Varieties

In the 1992 policy on new plant varieties, FDA recommended that developers consult with FDA about bioengineered foods under development; since the issuance of the 1992 policy, developers have routinely done so. To date, FDA's interactions with developers have taken three forms: biotechnology final consultations, new protein consultations, and rarely, the establishment of a food master file or submission of a food additive petition.

In the Federal Register of January 18, 2001 (the premarket notification proposal; 66 FR 4706, available as text and 193 KB PDF), FDA proposed a rule that would require that developers submit a scientific and regulatory assessment of the bioengineered food 120 days before the bioengineered food is marketed. In the premarket notification proposal, FDA recommended that developers continue the practice of consulting with the agency before submitting a premarket notice.

A developer who intends to commercialize a bioengineered food may meet with the FDA to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food in an initial consultation. With or without an initial consultation, a developer may submit to FDA a summary of its scientific and regulatory assessment of the food (the final consultation). Submissions to the agency under the 1997 guidance are designated biotechnology notification files (BNF). FDA evaluates the submission and responds to the developer by letter. FDA maintains an inventory of Biotechnology Consultations on Food from GE Plant Varieties, which includes the agency's response to the developer and the text of the agency's final memorandum regarding the submission.

1. Biotechnology Consultations: www.fda.gov/food/submissions...-consultations
2. New Protein Consultations: https://www.fda.gov/food/submissions...-consultations
3. Food Additive Petitions: www.fda.gov/food/submissions-bioengineered-new-plantvarieties/food-master-files-food-additive-petitions

Regulatory Agencies for GE Crops

The FDA regulates human, and animal food from genetically engineered (GE) plants the same way they regulate all food. The existing FDA safety requirements impose a clear legal duty on everyone in the farm to table continuum to market safe foods to consumers, regardless of the process by which such foods are created. It is unlawful to produce, process, store, ship, or sells to consumers unsafe foods.

Three federal agencies evaluate new crop varieties developed using genetic engineering: the FDA, the USDA, and the EPA. www.fda.gov/food/food-new-plant-varieties/how-fda-regulates-foodgenetically-engineered-plants

1. FDA: Evaluates food and feed safety. The FDA’s Center for Food Safety and Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM) evaluate new GE crops. They look for increased allergens, toxins, and changes in nutrition or composition. The FDA's main concerns here are threats to human health through food and threats to animal health through feed. What the FDA is comparing these genetically modified products is their unmodified counterpart. The FDA may then issue a statement about the modified food's substantial equivalence but does not approve the food as "safe," per se.
2. USDA: Ensures agricultural and environmental safety. The USDA, through the Biotechnology Regulatory Service (BRS) office of the Animal and Plant Health Inspection Service (APHIS), regulates all GE crops before commercial release. The USDA's primary concern is whether the new plant will harm agriculture or the environment. The USDA's authority over these matters is derived from the Plant Protection Act of 2000.
3. EPA: Evaluates food safety and environmental issues associated with new pesticides. The EPA regulates GM crops that have altered pesticide characteristics. Bt GM corn is an example of a product that the EPA would evaluate. Bt corn is genetically modified to contain what’s known as a “Plant Incorporated Protectant” (PIP). In other words, the Bt corn produces its insecticide. The EPA evaluates this type of product for its impact on the environment and human health.

Test Your Knowledge!

Visit the EPA website: http://www.epa.gov/ The EPA is currently responsible for regulating GE plants. Why do you think the EPA is concerned about GE plants? What is the Food Quality Protection Act?