Sunday, September 20, 2015

USDA, FDA, and EPA: How's That Working for You?

[Food and Technology, Business and Politics]

When I think about biotech in relation to our foods, both in regards to the genetically engineered products themselves and the chemical protocols that accompany them, I ponder the efficacy of our various governmental agencies overseeing and regulating this field – USDA, FDA and EPA. From there, I am reminded of a phrase used by the popularized TV personality psychologist Dr. Phil, “How’s that working for you?”  I think that is a question each of us should be asking ourselves.

When trying to understand what roles various governmental agencies have in the oversight and regulation of genetically engineered products, one can quickly find themselves going down the proverbial ‘rabbit hole’ while attempting to navigate our massive and complex regulatory system.  This article attempts to bring relevant detail forwards, yet also distill this information into some very simple points.

In the United States, when deciding whether or not a genetically engineered (GE) product is safe for the environment and for consumption, the primary regulating agencies involved are:
  • United States Department of Agriculture (USDA) – ensures that biotech products are safe for agriculture and the environment.
  • United States Environmental Protection Agency (EPA) – focuses primarily on chemicals use such insecticides and herbicides.
  • Food and Drug Administration (FDA) - centered on food and feed safety. Once called the Food, Drug and Insecticide Administration.
All three agencies (USDA, FDA, and EPA) overlap in their responsibilities, but each also has unique duties.

What follows is an overview of these three agencies in greater detail and primarily in the context of GE products including both production and consumption:

United States Department of Agriculture (USDA)

The USDA is a regulatory agency that monitors and regulates the use of biotechnology for agricultural purposes. They have the responsibility of reviewing data generated from field trials to determine whether a product or crop would have the potential to become a plant pest or cause any detrimental effects on the environment. Genetically engineered herbicide-tolerant crops are included in this because they do not actually produce a pesticide, which would be the responsibility of the EPA (discussed below). Instead, herbicide-tolerant crops are engineered to produce a protein which are resistant to a specific herbicide sprayed on them. An example of this is glyphosate-tolerant (e.g., Roundup Ready) soybean, corn, and canola.

The USDA is comprised of several agencies that are all designed to advise different groups to meet their specific needs. A relevant example is the Animal and Plant Health Inspection Agency (APHIS). The Animal and Plant Health Inspection Agency regulates the movement, importation, and field testing of genetically engineered organisms through permitting and notification procedures. APHIS also is responsible for inspecting veterinary biologics production. In fact, as just one agency within the USDA, APHIS has a very broad focus including:
  • Animal Health
  • Animal Welfare
  • Biotechnology Regulatory Services (BRS)
  • Marketing and Regulatory Programs Business Services (MRPBS)
  • Civil Rights
  • Emergency Response
  • Imports and Exports
  • International Services
  • Plant Health
  • Science Services
  • Tribal Relations
  • Wildlife Damage
To further illustrate how wide and deep this division of the USDA is, the APHIS’ scientific facilities include the:
•          Center for Plant Health Science and Technology, where scientists evaluate risks associated with the introduction of plant pests and develop methods to exclude, detect, and manage invasive plant pests and weeds;
•          Centers for Epidemiology and Animal Health, where multidisciplinary specialists track emerging animal health threats, monitor U.S. livestock management and production, design comprehensive animal health surveillance programs, and conduct risk assessments to identify situations that could impact the health of U.S. animal agriculture;
•          National Wildlife Research Center, the world’s only research center devoted entirely to the development of methods for effective wildlife damage management;
•          National Veterinary Services Laboratories (NVSL), the Nation’s premier animal health diagnostic laboratory and a World Animal Health Organization reference laboratory for animal diseases of importance to the Americas; 
•          Foreign Animal Disease Diagnostic Laboratory, a high-security biocontainment facility, part of the NVSL, where experts diagnose and develop tests for foreign animal diseases that threaten U.S. animal agriculture, as well as maintain forensic capabilities that can be used in the event of potential bioterrorist releases;
•          National Animal Health Laboratory Network, an extensive and integrated system of Federal, State, and university laboratories that provide animal disease diagnostic services in both routine and emergency situations, including bioterrorism events;
•          Center for Veterinary Biologics, the Nation’s sole laboratory involved in the testing and regulation of commercial veterinary biologics (vaccines and diagnostic kits) in the United States; and the
•          Center for Animal Welfare, where APHIS specialists collaborate with a diverse network of external partners and experts to serve as a national and international resource for animal welfare science, training, education, and policy strategy.

A few other agencies included within the USDA are the Forest Service, Risk Management Agency, and Agricultural Research Service.

The USDA APHIS unit that plays the most critical role in the evaluation and regulation of transgenic organisms is the office of Biotechnology Regulatory Services (BRS). In the regulation of genetically engineered organisms, BRS is critical part of a science-based federal regulatory framework to protect America's agricultural resources and the broader environment. The work of BRS is coordinated across four program divisions; Policy Coordination Programs, Biotechnology Risk Analysis Programs, Regulatory Operations Programs, and Resource Management Programs. Each program plays a unique role in accomplishing BRS goals.

Environmental Protection Agency (EPA)

The EPA’s mission is to protect the quality and health of the environment. In terms of protecting the environment from biotechnology products, their main focus is on the regulation of pest management products. There are three categories of pesticides the EPA reviews for registration. The three pesticide categories are antimicrobials, biopesticides, and conventional pesticides. Before a pesticide can be used, it has to be approved by the EPA to ensure that is it not harmful to humans or the environment. For this article, we will focus on the EPA’s role in regulating biopesticides, specifically Plant-Incorporated Protectants (PIPs). Biopesticides consist of biochemical pesticides, microbial pesticides, and PIPs. Plant-Incorporated Protectants are pesticidal substances produced by plants containing added genetic material. When regulating PIPs, the EPA regulates the new protein and its genetic material, not the plant itself.  However, it is worth noting that protocols accompanying some GE crops include the use of controversial chemicals such as various formulations containing glyphosate or 2,4-D.

Food and Drug Administration (FDA)

The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. Additionally, the FDA has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.  Finally, the FDA plays a significant role in the Nation’s counterterrorism capability. They fulfill this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

The following is a list of traditionally-recognized product categories that fall under the FDA’s regulatory jurisdiction; however, this is not an exhaustive list.  In general, the FDA regulates:
Foods, including:
•      dietary supplements
•      bottled water
•      food additives
•      infant formulas
•      other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products)
Biologics, including:
•      vaccines
•      blood and blood products
•      cellular and gene therapy products
•      tissue and tissue products
•      allergenics
Medical Devices, including:
•      simple items like tongue depressors and bedpans
•      complex technologies such as heart pacemakers
•      dental devices
•      surgical implants and prosthetics
Veterinary Products, including:
•      livestock feeds
•      pet foods
•      veterinary drugs and devices
Drugs, including:
•   prescription drugs (both brand-name and generic)
•   non-prescription (over-the-counter) drugs
Electronic Products that give off radiation, including:
•   microwave ovens
•   x-ray equipment
•   laser products
•   ultrasonic therapy equipment
•   mercury vapor lamps
•   sunlamps
Cosmetics, including:
•   color additives found in makeup and other personal care products
•   skin moisturizers and cleansers
•   nail polish and perfume
Tobacco Products, including:
•   cigarettes
•   cigarette tobacco
•   roll-your-own tobacco
•   smokeless tobacco

Biotech crops go through rigorous testing for several years before they are ever put on a farmer’s field. In the U.S., there are nine steps in the regulatory process that usually take seven to ten years to complete, which is a far more lengthy process than any conventionally derived food ever goes through. The USDA/APHIS is responsible for ensuring that any released organisms are safe and will not pose any negative effects on the environment, whereas the EPA evaluates the safety of transgenic plants containing PIPs. They consider where and how the protein is produced in the plant and its potential to be toxic to humans and other organisms.

Before pesticides can be marketed, the EPA considers factors regarding PIPs such as: 
- Risks to humans 
- Risks to non-target organisms and the environment 
- Gene flow potential 
- Insect resistance management plans 
The EPA also requires certain tests to be conducted to identify any risks to humans and the environment. These tests are listed below. 
- Identification of new genetic material and all new proteins 
- Mammalian toxicity testing of all new proteins 
- Comparison of new proteins to known toxins and allergens 
- Toxicity testing on birds, fish, earthworms, insects such as bees, ladybird beetles, and lacewings 
- Toxicity testing on insects related to target insect pests 

Length of time required for the new proteins to degrade in the environment
The development of a transgenic plant requires researchers to meet with one or more regulatory agency (EPA, USDA/APHIS, or FDA) to discuss the outline of the projects and decide which studies will be necessary to ensure safety of the end product. Throughout the study the developer sends the data of the ongoing research to the appropriate agency. For many biotech crops, the product then goes through a deregulation process in which the USDA/APHIS reviews the data received from the developer and decides whether or not the transgenic plant causes a negative outcome in the environment by genetically crossing with native species or out-competing them. They also try to ensure that the transgenic plant does not have any negative effects on wildlife, and does not become a “super-weed.” The overall goal of the regulatory agencies is to ensure that biotech crops are as safe as their non-genetically modified counterparts.

Successfully Preventing a “Super-weed” and Insect Resistance?

A “super-weed” can occur in two ways: (1) when pollen from a genetically modified crop pollinates a weedy relative and that weedy relative then becomes resistant to the herbicide that was originally produced to kill it, and (2) when an herbicide-tolerant crop escapes cultivation and becomes a weed. For this reason, the EPA developed a regulatory framework to help ensure that the appropriate tests are done to maintain that biotech crops are safe for the environment.

The infestation of superweeds has more than doubled since 2009, according to Dow Chemical, which also states that an estimated 70 million acres of U.S. farmland are infested with pesticide-tolerant weeds that cost roughly $1 billion in damages to crops so far.

In an email response to, a Dow spokesperson wrote: "We agree with our critics that with unvarying use of the same model of weed control action ... weeds will adapt. We differ from critics however, in that we believe the best way to promote responsible use of weed control technology is to provide growers with the broadest practicable range of weed control options."

Weed resistance to Roundup has forced farmers to turn to higher-risk herbicides such as 2,4-D, one of the components of Agent Orange used in the Vietnam War. As a supposed solution to the Roundup-resistance, biotech companies have genetically engineered corn and soybeans to be tolerant of 2,4-D. As the biotech companies try to get these new crops approved, scientists and organizations worry what effect that will have on the environmental, air, and water. The study from Environmental Sciences Europe projects that if these new crops are approved, the volume of 2,4-D sprayed could increase herbicide usage by about another 50%.

Other companies making grains resistant to herbicides include Pioneer, Syngenta and Monsanto, the world's largest producer of GMOs.

A concern with insect resistant crops, such as Bt corn, is that insects feeding upon the corn will eventually become resistant to the transgenic plant, defeating the purpose of growing the insect-resistant plant. The EPA has taken precautions to help prevent this scenario by suggesting that farmers who grow genetically engineered crops to also grow conventional crops nearby as “refuges” where insects aren’t exposed to the genetically modified crop that contain insect resistance. In theory this allows non-resistant insects to continue breeding and remain present in the environment, and mate with any resistant survivor of the genetically modified crop. A non-resistant insect that mates with a resistant insect helps to ensure that the dominant gene of non-resistance evolves from one generation to the next, which maintains a population of insects that will still be susceptible to the insect-resistant crops.

However, in the last several years, farmers and scientists have found rootworms with resistance to Bt corn. A study published in Proceedings of the National Academy of Sciences by entomologists at Iowa State University and the University of Illinois asserts numerous incidents in different states across the US of resistant rootworm.[8][9] Initially, the rootworm was only resistant to one of the three varieties of Bt corn. However, scientists have now found resistance to a second variety as well. In addition, developing resistance to one variety increases the chance of developing resistance to a second. So the effort of biotech companies to create new genetically engineered seeds with “stacked traits” in one doesn’t seem like a solution that will be effective in the long run.

To help combat the problem, scientists say larger refuges with non-Bt corn need to be planted as well as planting different crops year to year. While an advisory panel to the EPA back in 2002 said that 50 percent of each corn field should have only non-Bt corn, the biotech companies and EPA managed to merely recommend that 5 to 20 percent be dedicated to non-Bt corn.


Governmental regulatory bodies and practices in the US may not be as effective as we think (or hope). Contrary to the claim made by the biotech companies producing and patenting the genetically modified seeds, our herbicide and pesticide use has actually increased since the adoption of GMO crops. A study published by Environmental Sciences Europe found that between the years 1996 and 2011, herbicide use in the United States increased by 527 million pounds. Pesticide use is estimated to have increased by 404 million pounds, about 7%.  Additionally, the true toxicity of herbicides such as glyphosate, dicamba and 2,4-D is only now coming to light.

Similarly, the EPA has only made recommendations regarding the planting ration of Bt and non-Bt corn, and just as environmental scientists have predicted, we now have increasingly rampant infestations of Bt resistant rootworms.

Once again, this is the information I have been able to collect, but it would be best if you would do your own research and come to your own conclusions.