STS DEBATE

GMOs: ARE THEY GOOD OR BAD?

INTRODUCTION

A genetically modified organism, or GMO, is an organism that has had its DNA
altered or modified in some way through genetic engineering. (livescience.com)

They are produced using scientific methods that include recombinant DNA technology
and reproductive cloning. In reproductive cloning, a nucleus is extracted from a cell of
the individual to be cloned and is inserted into the enucleated cytoplasm of a host egg (an
enucleated egg is an egg cell that has had its own nucleus removed). The process
results in the generation of an offspring that is genetically identical to the donor
individual.
GMOs produced through genetic technologies have become a part of everyday life,
entering into society through agriculture, medicine, research, and environmental
management. (britannica.com) Julia M. Diaz & Judith L. Fridovich-Keil

GMOs are already very common in the farming industry. The most common genetic
modifications are designed to create higher yield crops, more consistent products,
and resist pests, pesticides and fertilizer. (livescience.com) Marc Lallanilla

Benefits of GMO
(sciencing.com) Nola Moore

benefits to producers
GMOs can have many benefits for food producers. Plants can be designed to be insect-
resistant, heartier or to grow under more extreme conditions. Animals can be modified to
give more meat or milk, or to grow faster. This results in higher yields for farmers and
better products. One example is slow-ripening tomatoes, which can be stored longer,
hold up better to transportation and still provide superior taste and texture for consumers
and manufacturers.

benefits to humans
In places where food is scarce or difficult to grow, plants and animals can be modified to
provide more nutrients and grow better under harsh conditions. Scientists have added
vitamins and minerals to staples like rice and corn to fight malnourishment in
underdeveloped countries. Plants are more drought-resistant and easier to grow. Many
plants are designed to use less pesticides and chemicals to grow, which means less
exposure to these potentially toxic substances for farmers and consumers.

benefits to the environment

Many GMOs are tailored for specific environmental conditions, which means saving water
in drought-prone areas and less use of chemicals. Higher yields and more efficient
growth mean that the same amount of food is produced on less land, using fewer natural
resources. Plants and animals become resistant to certain environmentally specific
pathogens and insects, which reduces the chance of losing a crop to disease.

HEALTH
(inside.batellete.org) biotechnology expert Josh Arnold, Ph.D.

GMOs are tested for safety and allergen potential before they go to market.
In the United States, GM food products must be rigorously tested before they can be sold
—far more so than conventionally bred crops. The testing process can take 7-10 years,
and must include evaluations of potential risks to humans and livestock as well as
potential risks to wildlife and the environment.
Part of the testing includes nutritional analysis and protein analysis and
characterization. In these studies, researches look at the proteins and peptides
expressed in the bioengineered organism compared to the original. This allows
researchers to identify any new proteins created by the GM crop that could produce an
allergic reaction or other adverse effect. Battelle helps companies conduct many of the
required studies, including allergen testing for GMO products.
In fact, GM food products are among the most tested products in history.
A meta-study of more than 1,700 peer-reviewed studies found no evidence that GMO
crops produce adverse affects in humans or livestock. And a recent review of 29
years of livestock health and productivity statistics—looking at relevant data from both
before and after the introduction of genetically engineered feed and covering more than
one billion animals—concluded that GM feed is every bit as safe and nutritious as non-
GM.
Based on peer-reviewed evidence, the World Health Organization, the American
Medical Association and the British Royal Society, among others, have all
concluded that foods containing GM ingredients are as safe as the same foods
containing ingredients from crop plants modified by conventional techniques.

(bestfoodfacts.org)

What are the health risks of eating GMO foods? Are GMO foods less nutritious? Do they
cause allergies? What foods are GMOs? To address our reader’s concerns, we put these
questions before a panel of experts:

Peggy Lemaux, Cooperative Extension Specialist at the University of California –

Berkeley
Wayne Parrott, Professor in the Department of Crop and Soil Sciences College of
Agricultural & Environmental Sciences University of Georgia, University of Georgia
Bruce Chassy, Professor of Food Microbiology and Nutritional Sciences; Executive
Associate Director of the Biotechnology Center; Assistant Dean for Science
Communications in the College of Agricultural, Consumer and Environmental Sciences,
University of Illinois – Urbana/Champaign
Martina Newell-McGloughlin, Director, University of California Systemwide
Biotechnology Research and Education Program (UCBREP), Co-Director, National
Institutes of Health Training Program in Biomolecular Technology, Co-Director, NSF
IGERT CREATE Training Program, and Adjunct Associate Professor, Department of Plant
Pathology at the University of California-Davis.
——————————————————-
Are GMO fruits and vegetables less nutritious than non-GMO or organic fruits and
vegetables?

Dr. Lemaux: “That’s a good question! Foods that have been genetically modified undergo
testing for safety, health and nutrient value. The nutritional value of GMO foods is tested
and compared against non-GMO foods. Numerous studies have shown no nutritional
differences between commercially available GMO and non-GMO foods. In fact,
genetic modification can improve the nutritional content of some foods, for example,
low linoleic acid canola oil that can reduce trans-fat content. In these cases, the foods
must be labeled to show the nutritional differences according to FDA policy.”

Dr. Chassy: “Recent reviews have concluded that there is no difference in nutrient
quality between organic and non-organic produce. Some disagree because they
believe (not based on science, but rather, personal beliefs) that organic matter derived
from living organisms provides a vital life force to crops that cannot be supplied by
inorganic chemical fertilizers. This is just not the case when we look at this based on
research. This thinking has transitioned into a belief by some that organic is more
nutritious, which has simply not been proven.”
—————————————————-
Do GMOs cause allergies?

Dr. Lemaux: “GM foods that are in the grocery stores (commercially available) are not
likely to cause allergic reactions any more so than non-GM foods. Food allergies are
nothing new, and under the FDA’s biotechnology food policy, GMO foods must be labeled
as such if the genetic information comes from one of the eight most common allergy-
causing foods, unless the new food is shown to be allergy-free. Those foods are dairy,
eggs, fish, shellfish, tree nuts, wheat, soybeans, and peanuts. All GMO foods undergo
food safety testing that focuses on the source of the gene or protein product that
has been introduced into the food. Even so, no food product can be deemed 100%
safe, whether it be conventional (non-GMO), GMO or organic. For example, peanuts
can cause severe allergies regardless of how they’re grown – so they would be considered
unsafe for some people.’

Are there health risks associated with consuming GMOs?

Dr. Newell-McGloughlin: “No. GMOs are more thoroughly tested than any product
produced in the history of agriculture. We use many methods to introduce desired traits
– to try to get specific characteristics into our crops. With GMOs, they are thoroughly
tested before any product is released into the marketplace. In all the risk assessments in
over 15 years of field research and 30 years of laboratory research, there hasn’t
been a single instance where there was a health risk associated with a GMO
product.”
————————————————
Science Magazine: U.S expert panel says genetically modified crops are safe to eat
Some believe that the FDA’s research on GMOs’ impacts on health is flawed. What
are your thoughts on that?

Dr. Parrott: “Although there is no indication that the FDA has made a wrong call on
any GM product, the point remains that we are in a global economy. Thus, it is not
just FDA who approves these foods, but also FoodCanada, the European Food
Safety Authority, the Food Standards for Australia and New Zealand, and various
agencies in Japan and Korea, among others. It is one thing to say that FDA ’s
procedures might be flawed; it is another to say every major food safety agency is
flawed. Thus far, I am not aware of any situation whereby one agency gave a GM product
a clean bill of health and another failed to do so.”

PRODUCTION
(gmo.geneticliteracyproject.org)
USDA Animal and Health Inspection Service, shows the variety of GMO crops that have
been approved in the US:
- corn
- soybean
- cotton
- potato
- papaya
- squash
- canola
- alfalfa
- apple
- sugar-beet
The adoption rate in the US of GM corn, soybeans and cotton has been overwhelming
since their introduction in 1996. Today, more than 90% of corn, soybeans and cotton
(cottonseed oil is often used in food products) is grown from genetically modified
seeds. Farmers choose biotech seeds for a variety of reasons. They help manage weeds,
control insects, prevent crop diseases, increase productivity or enhance nutritional content.

(en.m.wikipedia.org)

In 2013, GM crops were planted in 27 countries; 19 were developing countries and 8

were developed countries. 2013 was the second year in which developing countries grew
a majority (54%) of the total GM harvest. 18 million farmers grew GM crops; around 90%
were small-holding farmers in developing countries.[1]

Country 2013– GM planted area (million hectares) Biotech crops

US 70.1 Maize, Soybean, Cotton, Canola,
Sugarbeet, Alfalfa, Papaya, Squash

Brazil 40.3 Soybean, Maize, Cotton

Argentina 24.4 Soybean, Maize, Cotton

India 11.0 Cotton

Canada 10.8 Canola, Maize, Soybean, Sugarbeet

Total 175.2 ——

In recent years GM crops expanded rapidly in developing countries. In 2013

approximately 18 million farmers grew 54% of worldwide GM crops in developing
countries.
REGULATION

(Agricultural Biosecurity) Dr. Jonathan Tucker

Regulation of GM crops in the United States is divided among three regulatory agencies:
the Environmental Projection Agency (EPA), the Food and Drug Administration
(FDA), and the U.S. Department of Agriculture (USDA). Each of these agencies
regulates transgenic crops from a different perspective.

EPA regulates biopesticides, including Bt toxins, under the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA). If a crop is genetically engineered to carry a gene
for a Bt toxin, EPA requires the developer to verify that the toxin is safe for the
environment and conduct a food-safety analysis to ensure that the foreign protein is
not allergenic.

FDA is responsible for regulating the safety of GM crops that are eaten by humans
or animals. According to a policy established in 1992, FDA considers most GM crops as
“substantially equivalent” to non-GM crops. In such cases, GM crops are designated as
“Generally Recognized as Safe” under the Federal Food, Drug, and Cosmetic Act
(FFDCA) and do not require pre-market approval. If, however, the insertion of a transgene
into a food crop results in the expression of foreign proteins that differ significantly in
structure, function, or quality from natural plant proteins and are potentially harmful to
human health, FDA reserves the authority to apply more stringent provisions of FFDCA
requiring the mandatory pre-market approval of food additives, whether or not they are the
products of biotechnology.

(forbes.com) Dr. Ray Dobert - Regulatory Policy Lead at Monsanto

“GMOs go through a rigorous regulatory process to ensure they’re safe to go to market. In

fact, the regulatory review process alone can take more than three years to grant
approval of a new GM crop product, and overall it typically takes over 13 years for a
new trait to go from an idea to the field.”

Research and testing: The first steps in the regulatory process for GM
crops
Long before developers submit genetically modified (GM) crops to U.S. regulatory
agencies and other global agencies for review, they conduct many years of research and
testing, regulated field trials and internal reviews of these crops.

Developers conduct extensive tests to make sure the GM crop contains the same
components and levels of nutrients as its conventional varieties. Specifically, the GM
crop is analyzed to make sure that, compared to conventional crops, it has similar levels of
protein, carbohydrates, fat, amino acids, fiber and vitamins, as well as a variety of other
components.

Any gene that is added to the GM crop is thoroughly studied and characterized.
Scientists examine how the gene works, conduct environmental and ecological
assessments in the lab and field, and confirm that there are no health concerns posed
by the gene and/or the protein produced by the gene. This includes thorough testing to
verify that any such proteins do not introduce a new food allergen. Because existing food
crops are recognized as safe, the tests on the GM crop must demonstrate that it is not
substantially altered from the non-GM crop in terms of its use as food or feed, or in terms
of its environmental safety. This is referred to as “substantial equivalence.”

The review process: The EPA, FDA and USDA evaluate GM crop safety
Next, GM products are examined by regulatory agencies around the world. In fact,
the U.S. framework for regulation has been in place since 1986 when the Office of Science
and Technology Policy (OSTP) established the “Coordinated Framework”. This policy
document established the roles and responsibilities of the Environmental Protection
Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of
Agriculture (USDA), and articulated how they would use existing laws related to food and
feed safety, crop introduction and pesticides to regulate GMOs.

Under the Framework, the USDA evaluates whether the plant is safe to grow, the FDA
evaluates whether the food derived from GM plants are safe to eat, and the EPA
evaluates certain GM plants that are resistant to pests for environmental safety.
Collectively these three agencies regulate all stages of the development of GM
plants from initial field trials through commercialization. In addition to the safety
assessments conducted by U.S. regulators, similar reviews are conducted by over a
hundred regulators around the world. Only after this process is complete are farmers
allowed to grow a new GM crop product in the United States.

The Coordinated Framework lays out these general principles and responsibilities for each
agency:

1. USDA regulates the importation, movement and confined field trials of GMOs via
permitting and notification processes. Once adequate data has been collected the
product developer can petition the USDA to deregulate a particular GM product.

2. FDA has authority over the safety of all food, food ingredients and animal feeds.
The FDA has a consultation process to assure that GM food and feed products are
as safe as their conventional counterparts that are already on the market. While the
consultation process with the FDA is voluntary, all of the GM products on the market have
gone through this process. In addition, the FDA has the authority to recall any food or
ingredient it finds is not safe for consumption.

3. EPA has regulations that require evaluation and registration of all pesticidal
products including GM crops, like Bt crops, that are used to repel or kill pests.

A regulatory process that evolves alongside science and government

policy
At the time that the Framework was established, regulators acknowledged that it should be
“expected to evolve in accord with the experiences of the industry and the agencies, and,
thus, modifications may need to be made.” Since then, numerous modifications and
updates have been made to reflect the increased experience and familiarity with GM crops
as they are grown by farmers on millions of acres. Just earlier this year, OSTP issued a
call to the regulatory agencies to once again look at their policies and regulations, and with
input from the public, recommend what changes might help the Framework continue to
function smoothly in the coming decades.
This regulatory process continues to evolve and has proven to be effective in
assessing the safety of the many GM crop products that are now available to
farmers. In the nearly 20 years that these products have been on the market, they
have delivered numerous benefits to growers and the environment and have not
had a single documented instance of harm to human or animal health.