Frequently Asked Questions

1. Is biotechnology making agriculture and food "unnatural"?
All agriculture besides the niche organic market requires some sort of enhancement. Plants on modern farms need fertilizer, to grow, and protection, such as herbicide or pesticide, to grow to maturity. With biotechnology, plants can be developed that require none of these.
People already have been eating genetically modified fruits and vegetables for generations without realizing it. If you eat tomatoes, then you eat genetically modified food. "Natural" tomatoes in the wild are small, green, and bitter. Selective crossbreeding has occurred for over one hundred years, but now genetic modification is done more selectively with greater knowledge and precision.
2. Does biotechnology provide any benefit to consumers?
Yes, there are considerable benefits to consumers. Cheaper, more effective pharmaceuticals developed through biotechnology deliver concrete benefits to thousands of patients every day. Biotech agricultural products, created through techniques fundamentally related to those used for pharmaceuticals, offer increased yield -- which leads to lower costs -- increased nutritional content, reduced spoilage, and reduced pesticide use. (In the U.S. 2 million fewer tons of pesticide were used in 1998 because of bio-engineered cotton's resistance to weevils). Research is underway towards the development of products with more direct benefits to consumers, such as, for example, bananas fortified with vaccines.
In terms of the environment, bioremediation benefits society through the use of bio-engineered bacteria to clean up oil spills. Biotechnology is producing new biodegradable materials to replace non-degradable plastics. Eventually, biotechnology offers the promise of a replacement for fossil fuels. As in the food area, the chances of realizing the environmental promises of biotechnology are reduced by exaggerated fears of this promising technology.
But, the research into improved second and third generation biotechnological products will slow down or cease if the market for the first generation of products dries up.
3. Are biotechnologically engineered products safe? How is a consumer to know?
To date, no harmful effects to consumers from biotechnologically engineered products have been demonstrated. There can be risks associated with all foods and biotech products are already subject to intense scrutiny. When it was discovered in the course of research that a Brazil nut gene being used in the development of a new biotech product carried allergens, work on the product ceased long before the product would have reached the marketplace. Finally, in the United States we have a tried and true method of protecting consumer interests - the lawsuit. None have been won against biotechnological products.
4. Does biotechnology have any real benefits for developing countries?
Critics of biotechnology maintain that it offers nothing for the developing world but further subjugation to multi-national companies. The problem of hunger, critics argue, involves politics and the distribution of food, not the means of agriculture. Solve the political problems of the developing world first, they say, which would then ensure delivery of the food supply, which theoretically is ample for the world's population.
By 2025, it is estimated that the world's population will exceed eight billion, one billion of whom will be under-nourished if current trends continue. Feeding this expanding world will require an eighty per cent increase in the average yield of cereals from the amount in 1990. This increase must come primarily from greater biological yields, since we believe expanding planting areas or irrigation are not options, given the already heavy demand on our fragile ecosystem.
Below are some examples of innovations in biotechnology that offer promise for the developing world.
-- Vitamin A deficiency afflicts 1.4 billion women and 800 million children, causing poor growth, high rates of infection, respiratory diseases and blindness. The Rockefeller Foundation and the Swiss Federal Institute of Technology together are developing new strains of rice, a staple in developing countries, that will be fortified with Vitamin A and iron. How will the new "golden rice" be delivered to those in need? Companies have waived their intellectual property rights to enable the Swiss Institute to offer its "golden rice" free of charge and without restriction for non-commercial use in Asia, Africa, and Latin America. It will be ready for planting within five years.

• Tuskeegee University, in Alabama, is developing an improved sweet potato, a staple in sub-Sahara Africa and South Asia, which will have much higher protein and amino acids necessary for healthy growth among children.
• High Quality Corn, a biotechnologically engineered product distributed by the Carter Center, is already being planted and is demonstrably improving health in countries such as Ghana, where it serves as a healthy, single food source for mothers weaning their babies.
• Hepatitis B is a major health problem in Africa. Cornell University scientists have found a way to modify bananas to include hepatitis B vaccine, reducing the cost per dose from $200 to 10 cents, and eliminating the need for medical personnel to administer.

Per Pinstrup-Anderson, Director General of the International Food Policy Research Institute, has put it: "It is unethical to withhold solutions to food problems that cause children to die."
5. Does biotechnology involve a risk of "Geneflow"?
There is genuine concern that biotechnologically altered plants might have an effect on the environment by the spread of their pollen altering neighboring wild plants. The key point is that pollen can only affect very closely related plants. The thousands of acres of Bt cotton in the U.S. have no "geneflow" effect because there are no plants genetically similar enough to cotton for cotton pollen to have any effect on them. Field studies on sweet potatoes have shown some geneflow to wild sweet potatoes planted deliberately nearby, but much less than predicted by researchers.
6. Can biotech discoveries be patented?
Yes. But this does not mean that the holder of the patent "owns" the biological basis of the discovery.
A patent is a legal device for granting an inventor or discoverer a period of exclusivity or monopoly over an invention, so that the inventor/discoverer can benefit from the invention/discovery without having it copied or imitated.
Patent terms vary between countries, although the period is being harmonized at 20 years under the GATT.
An invention or discovery must be novel and involve an inventive step in order to be patentable. It must also be industrially applicable, that is, it must have a useful purpose. The requirement for an inventive step ensures that the invention or discovery is different from what has been previously known. Because of the novelty and inventive step requirement, traditional knowledge is by definition not patentable. All major industrialized countries now routinely grant patents for living organisms, including yeasts, bacteria, viruses, mammalian cell lines, and plants. Claims to human beings, including embryos, are either explicitly excluded by clauses in legislation, or are regarded as contrary to other laws and therefore not allowable.
Patentable biotechnological inventions include living organisms (other than humans); cell lines; vaccines; antigens; antibodies; pharmaceutical formulations; starter cultures for wine, cheese, and beer; fermentation products, such as antibiotics, foods and beverages; methods of waste treatment; bioremediation of polluted soil or water; and chemical processes using enzymes or living organisms.
The existence of a patent does not affect research in the field. A patent covers only the commercial use of an invention or discovery. Research is either specifically exempted by law, or is held by the courts not to be an infringing activity. The only exception is that, in most countries, clinical and field trials performed in order to obtain regulatory approval are an infringement.
7. What is biotechnology?
Agricultural biotechnology is a collection of scientific techniques, including genetic engineering, used to create, improve, or modify plants, animals, and microorganisms. Before the development of biotechnology techniques, scientists worked to improve plants and animals for human benefit by using conventional techniques, such as selective breeding.
Modern techniques now enable scientists to move genes (and therefore desirable traits) in ways they could not before -- and with greater ease and precision.
"Genetically-modified organisms" (GMOs) is the term used by some countries to identify products produced through modern biotechnology. Since animal and plant hybridization and fermentation have involved genetic modification for over a century, U.S. regulators prefer the term "biotech" products.
Ten years of experience with commercialization of biotech food products in the United States and related numerous and ongoing findings, show that biotech foods developed to date present no unique food safety risks.
8. What does biotechnology do?
Some of the goals of modern biotechnology include endowing a conventional product with a trait that enhances its nutritional composition or a host plant with a desirable trait (such as pest or drought resistance) that enhances a plant's yield. For example, genes from a common microbe found in the soil and widely-used by organic farmers as a pesticide, Bacillus thuringiensis (Bt), can be inserted into the DNA of corn or other plants, to make the plant noxious to specific insect pests. The full possibilities of biotech are only now emerging as research continues.
9. How it is regulated in the United States.
For over a decade, U.S. biotech seed developers have submitted new seed varieties to the U.S. Department of Agriculture and U.S. Environmental Protection Agency for review and cooperated with these agencies to monitor environmental impact in field tests.
The U.S. review process uses a science-based approach to risk assessment. Once they have successfully passed the review, all seeds (biotech and non-biotech) are sold domestically and internationally with identifying transportation and handling documentation for planting and/or crossbreeding (with previously approved biotech and non-biotech varieties).
The U.S. Department of Agriculture reviews biotech seeds, crops in the field, and animals for slaughter.
The U.S. Environmental Protection Agency reviews the safety of pesticidal proteins in biotech products.
The United States Food and Drug Administration reviews foods produced from crops, animals and fish that are products of biotech processes.
All foods and processed foods in the U.S., including foods from bioengineered plants, have to comply with all the provisions of the Federal Food, Drug, and Cosmetic Act, including provisions covering safety and labeling.
In addition, the Food and Drug Administration has established a process by which companies can consult on food safety and labeling issues on new products before bringing them to market.
Under U.S. law, biotech foods are not commercialized unless they meet the same rigorous safety standards as their traditional counterparts.
10. Where it is used.
In 1998, 25 percent of U.S. corn acreage, 38 percent of soybean acreage, and 45 percent of cotton acreage were planted with biotech varieties. This represented a total of over 45 million acres, up 250 percent from 1997 levels. Worldwide, over 69 million acres of biotech crops were planted in 1998 (15 percent in developing countries).
Field tests are being conducted on over 50 new food, fiber, and feed crops.
11. What are the potential benefits for the consumers?
Biotechnology is expected to increase crop yields by 20% for smallholder farmers profitably without degrading natural resources. Since the world's population is expected to double to more than 10 billion people by 2030, using biotechnology to increase crop yields for land currently in agricultural use will ensure a more secure sustainable agricultural future.
Traits beneficial to humans could be added to plants. For example, corn, soybeans, canola, and other plants are being modified to reduce the saturated fat content of cooking oils derived from these plants. Potatoes are being modified to absorb less fat while frying. "Nutriceuticals" are being developed, including fruits and vegetables containing higher levels of certain nutrients such as Vitamins C and E, and beta carotene, to help reduce risk of chronic diseases such as some cancers and heart disease. Rice is being produced with an improved protein profile to include higher levels of the essential amino acid, lysine.
Edible vaccines are under development. For example, the May 1998 edition of Nature Medicine magazine reported on the clinical trial of the first edible vaccine introduced into potatoes (and hopefully bananas in the future). The results showed promise for the treatment of intestinal diseases in developing nations, the article reported.
Traits harmful to human health can be eliminated, too. For example, allergen-causing proteins can be removed from foods, including rice.
Biotech foods have the potential to help lower food prices through future advances that can enhance the production, distribution, packaging, and handling of biotech food products.
Biotech is providing new technologies for traditional production, such as brewing, baking and cheese making. It has already improved products vital to food making such as enzymes, proteins, and vitamins. For example, Rennin, an enzyme used to make cheese traditionally taken from the lining of calves' stomachs after slaughter, has now been reproduced in bacteria.
12. What are the potential benefits for the environment?
Some biotech crops could decrease the need for pesticides and herbicides to control pests, weeds, and plant diseases and allow more selective application of agricultural chemicals. For example, genes from a common microbe found in the soil and widely-used by organic farmers as a pesticide, Bacillus thuringiensis (Bt), can be inserted into the DNA of corn or other plants, to make the plant noxious to specific insect pests.
Biotechnology could provide enhanced resistance to natural climatic variations and lessen reliance on water source management. Plants could be made to withstand, for instance, a drop in temperature and frost by modifying their production of linoleic acid.
Biotech could decrease the pressure on natural resources such as tropical forests by making marginal lands (now fallow owing to salts, metal, acids) productive.
Biotech crops can potentially preserve the land's ability to support continued farming by reducing the need for tillage, which causes both soil and water runoff and soil nutrient depletion.
13. What are the potential benefits for farmers?
Taking advantage of the advances in the agricultural sciences can increase profitability for farmers. Biotechnology has improved the quality of seed grains and the ability to produce bigger harvests from land currently in cultivation. Increased yields and reduced chemical and labor costs would increase income for farmers.
Reductions in the use of pesticides and herbicides would lessen farm workers' exposure to toxic agricultural chemicals.
(The following questions and answers were compiled and written by
the State Department of the United States of America.)
14. Why make GM crops?
Traditionally, a plant breeder tries to exchange genes between two plants to produce offspring that have desired traits. This is done by transferring the male (pollen) of one plant to the female organ of another.
This cross breeding, however, is limited to exchanges between the same or very closely related species. It can also take a long time to achieve desired results and frequently, characteristics of interest do not exist in any related species.
GM technology enables plant breeders to bring together in one plant useful genes from a wide range of living sources, not just from within the crop species or from closely related plants. This powerful tool allows plant breeders to do faster what they have been doing for years-generate superior plant varieties-although it expands the possibilities beyond the limits imposed by conventional plant breeding.
15. Who produces GM crops?
Most of the research on transgenic crops has been carried out in developed countries, mainly in North America and Western Europe .
Recently, however, many developing countries have also established the capacity for genetic engineering.
In developed countries, the new life science companies have dominated the application of GM technology to agriculture. These include Aventis, Dow AgroSciences, DuPont/Pioneer, Monsanto/Pharmacia & Upjohn, Novartis, and Astra-Zeneca.

16. What is GM crop?
A GM or transgenic crop is a plant that contains a gene(s) that has been artificially inserted instead of the plant acquiring it through pollination.
The inserted gene (known as the transgene) may come from another unrelated plant or from a completely different species.
The resulting plant is said to be “genetically modified” although in reality all crops have been “genetically modified” from their original wild state by domestication, selection, and controlled breeding over long periods of time.
 
17. How are GM crops made?
Gm foods are made through a process known as genetic engineering. Genes of commercial interest are transferred from one organism to another. Two primary methods currently exist for introducing transgenes into plant genomes.
The first involves a device called a ‘gene gun'. The DNA to be introduced into the plant cells is coated onto tiny particles. These particles are then physically shot onto plant cells. Some of the DNA comes off and is incorporated into DNA of the recipient plant. The second method uses a bacterium to introduce the gene(s) of interest into the plants DNA.
 
18. What are the potential benefits of GM plants? 
In the developed world, there is clear evidence that the use of GM crops has resulted in significant benefits. These include:

• Higher crop yields
• Reduced farm costs
• Increased farm profit
• Improvement in the environment

These “first generation” crops have proven their ability to lower farm-level production costs. Now, research is focused on “second generation” transgenic crops that will feature increased nutritional and/or industrial traits. These crops will benefit the consumers. Examples include:

• Rice enriched with iron and vitamin A
• Potatoes with higher starch content
• Edible vaccines in maize and potatoes
• Maize varieties able to grow in poor conditions
• Healthier oils from soybean and conola

19. Where are GM crops currently grown?
In 1994, Calgene's delayed-ripening tomatoes (Flavr-Savr TM ) became the first genetically modified food crop to be produced and consumed in an industrialized country. Since then several countries have contributed to more than a 20-fold increase in the global area of transgenic crops.
The area planted to GM crops shot up from 1.7 million hectares in 1996 to 11 million in 1997 to 27.8 million 1998 to 39.9 million in 1999 and to 43 million in 2000. Countries that grow transgenic crops include Argentina , Australia , Bulgaria , Canada , China , France , Germany , Mexico , Ukraine , and the USA .
 
20. Are GM plants appropriate for developing countries?
While the debate over transgenic crops has taken place mainly in the developed nations in the North, the South stands to benefit from any technology that can increase food production, lower food prices, and improve food quality.
In conditions where there is often not enough food to go around and where food prices directly of the population, the potential benefit of GM crops cannot be ignored. It is true that nutritionally enhanced foods may not be a necessity in developed countries but they could play a key role in helping to alleviate malnutrition in developing countries.
Although, the potential benefits of GM crops are large in developing countries, they come at an expensive price. Most developing lack the scientific capacity to assess the biosafety of transgenic crops, the economic expertise to evaluate their worth, the regulatory capacity to implement guidelines for safe deployment, and the legal systems to enforce and punish transgressions in law. Fortunately, several organizations are working to build local capacity to manage the acquisition, deployment and monitoring of GM crops.
 
21. What are the potential risks of GM crops?
Of course, every new emerging technology, there are potential risks. These are:
•  The danger of unintentionally allergens and other antinutrition factors in foods
•  The likelihood of transgenes escaping from cultivated crops into wild relatives
•  The possibility that transgenic crops may generate antibiotic resistance in livestock or humans
•  The potential for pests to evolve resistance to the toxins produced by the GM crops
•  The risks of these toxins affecting nontarget pests.
Where legislation and regulatory institutions are in place, there are elaborate steps to precisely avoid or mitigate these risks. It is the obligation of the technology innovators (i.e., scientists), producers and the government to assure the public of the safety of the novel food that they offer as well as their benign affect on the environment.
There are also risks that are neither caused nor preventable by the technology itself. An example of this type of risk is the further widening of the economic gap between developed countries (technology users) versus developing countries (nonusers). These risks, however, can be managed by developing technologies tailor made for the needs of the poor and by instituting measures so that the poor will have access to the new technologies.