Agricultural biotechnology is a collection of
scientific techniques, including genetic engineering, that are used to create,
improve, or modify plants, animals, and microorganisms. Using conventional
techniques, such as selective breeding, scientists have been working to improve
plants and animals for human benefit for hundreds of years. Modern techniques
now enable scientists to move genes (and therefore desirable traits) in ways
they could not before—and with greater ease and precision.
How can biotechnology help farmers and consumers?
Combating human diseases—The first
biotechnology products were medicines designed to address human diseases.
Insulin, used to treat diabetics, and blood clot-busting enzymes for heart
attack victims are now produced easily and cheaply as a result of biotechnology.
New research by USDA's Agricultural Research Service (ARS) finds that transgenic
animals may be a new source of valuable hormones and drugs to treat emphysema
and infections in babies.
Promoting human health—Researchers are
creating ways to boost the nutritional value of foods using biotechnology.
Combating animal diseases—Biotechnology
helped produce a vaccine that protects animals in the wild against rabies and a
vaccine for "shipping fever" of cattle, the biggest killer of beef
cattle in feedlots.
Fighting hunger by resisting plant diseases
and increasing crop yields—Biotechnology can help farmers increase crop
yields and feed even more people. For example, an ARS scientist used
biotechnology to pinpoint a gene that could help wheat, a major food staple,
grow on millions of acres worldwide that are now hostile to the crop. ARS
scientists have also developed an experimental potato hybrid that contains genes
to resist a new, more virulent strain of the so-called "late blight,"
the disease that caused the Irish potato famine in the 1840s.
Helping the environment by reducing pesticide
use—Biotechnology can help farmers reduce their reliance on insecticides
and herbicides. For example, Bt cotton, a widely grown biotech crop, kills
several important cotton pests.
What are the safety considerations with
Breeders have been evaluating new products
developed through agricultural biotechnology for
centuries. In addition to these efforts, the
United States Department of Agriculture (USDA),
the Environmental Protection Agency (EPA), and
the Food and Drug Administration (FDA) work to
ensure that crops produced through genetic
engineering for commercial use are properly
tested and studied to make sure they pose no
significant risk to consumers or the
Crops produced through genetic engineering
are the only ones formally reviewed to assess
the potential for transfer of novel traits to
wild relatives. When new traits are genetically
engineered into a crop, the new plants are
evaluated to ensure that they do not have
characteristics of weeds. Where biotech crops
are grown in proximity to related plants, the
potential for the two plants to exchange traits
via pollen must be evaluated before release.
Crop plants of all kinds can exchange traits
with their close wild relatives (which may be
weeds or wildflowers) when they are in
proximity. In the case of biotech-derived crops,
the EPA and USDA perform risk assessments to
evaluate this possibility and minimize potential
harmful consequences, if any.
Other potential risks considered in the
assessment of genetically engineered organisms
include any environmental effects on birds,
mammals, insects, worms, and other organisms,
especially in the case of insect or disease
resistance traits. This is why the USDA's Animal
and Plant Health Inspection Service (APHIS) and
the EPA review any environmental impacts of such
pest-resistant biotechnology derived crops prior
to approval of field-testing and commercial
release. Testing on many types of organisms such
as honeybees, other beneficial insects,
earthworms, and fish is performed to ensure that
there are no unintended consequences associated
with these crops.
With respect to food safety, when new traits
introduced to biotech-derived plants are
examined by the EPA and the FDA, the proteins
produced by these traits are studied for their
potential toxicity and potential to cause an
allergic response. Tests designed to examine the
heat and digestive stability of these proteins,
as well as their similarity to known allergenic
proteins, are completed prior to entry into the
food or feed supply.
To put these considerations in perspective,
it is useful to note that while the particular
biotech traits being used are often new to crops
in that they often do not come from plants (many
are from bacteria and viruses), the same basic
types of traits often can be found naturally in
most plants. These basic traits, like insect and
disease resistance, have allowed plants to
survive and evolve over time.
Why has biotechnology become a trade issue?
Some people may not feel comfortable with new
technology. They may worry about environmental, social and economic consequences—real or simply feared. Particularly in Europe, these consumer concerns have
led to a resistance toward biotechnology-derived plants and food, though not
medicine. European consumer concerns may also be bolstered by a historic
distrust in their governments' ability to ensure the safety of the food supply
after the "mad cow" scare and more recent dioxin contamination.
Consequently, European governments have been slow to approve and permit the importation of
biotechnology-derived products, even if they have been proven safe to human and
animal health and the environment. This has created friction with the United
States and other trading partners, who believe sound science should be the basis
of regulatory systems.
The failure of other countries to develop
consistent and science-based regulatory processes governing biotechnology has
the potential to constrain scientific innovation and disrupt trade. USDA
recognizes and appreciates differences in the political, social, and cultural
situations in countries around the world. However, regulatory processes must be
predictable and transparent if they are to be understood and trusted by industry
and the public.
Which Federal agencies regulate agricultural biotechnology?
The Federal government has a well-coordinated
system to ensure that new agricultural biotechnology products are safe for the
environment and to animal and human health. While these agencies act
independently, they have a close working relationship.
- USDA's Animal and Plant Health Inspection
Service (APHIS) is responsible for protecting American agriculture against
pests and diseases. The agency regulates the field testing of genetically
engineered plants and certain microorganisms. APHIS also approves and
licenses veterinary biological substances, including animal vaccines, that
may be the product of biotechnology.
- USDA's Food Safety and Inspection Service (FSIS)
ensures the safety of meat and poultry consumed as food.
- The Department of Health and Human Service's
Food and Drug Administration (FDA) governs the safety and labeling of drugs
and the nation's food and feed supply, excluding meat and poultry.
- The Environmental Protection Agency (EPA)
ensures the safety and safe use of pesticidal and herbicidal substances in
the environment and for certain industrial uses of microbes in the
- The Department of Health and Human Service's
National Institutes of Health have developed guidelines for the laboratory
use of genetically engineered organisms. While these guidelines are
generally voluntary, they are mandatory for any research conducted under
Federal grants and they are widely followed by academic and industrial
scientists around the world.
What is APHIS's role in regulating biotechnology?
APHIS is the government's lead agency regulating
the safe testing, under controlled circumstances, of biotechnology-derived, new
plant varieties. A company, academic or research institution, non-profit
organization or public sector scientist wishing to field test or move (via
importation or interstate movement) a
biotechnology-derived plant must generally obtain APHIS approval before
If someone wants to test a biotechnology-derived plant,
what do they do?
Applicants ask APHIS for permission to allow
field testing (environmental release). They provide information about the plant,
including all new genes and gene products, their origin, the purpose of the
test, how the test will be conducted, and specific precautions to be taken to
prevent the escape of pollen, plants, or plant parts from the field test site.
An APHIS scientific reviewer evaluates the possible environmental impacts of the
proposed field test. The possible impact of new plant varieties on endangered or
threatened species is considered. Non-target species, those not meant to be
directly impacted by the new plant, are also taken into account.
In an effort to streamline the permit process,
most applicants can now use a simplified procedure in which they notify APHIS
before they plan to move or field test a biotech crop. APHIS then has 30 days to
review the notification prior to any testing. These field tests are still
required to meet all the same safety standards as trials that are approved
through the permit process.
Are other precautions taken if testing is approved?
If testing is approved, APHIS personnel and state
agriculture officials may inspect the field test site before, during, or after
the test to ensure that is conducted and managed safely.
What is necessary for commercial production of a biotech plant?
Generally, before a genetically engineered crop
can be produced on a wider scale and sold commercially, its creators must
petition APHIS for a "determination of non-regulated status," which
requires the submission of more information than a field test permit request.
APHIS must be provided scientific details about the genetics of the plant, the
nature and origin of the genetic material used, information about indirect
effects on other plants, field test reports, and even information unfavorable to
the petition. All petitions are published in the Federal Register and the public
is given time to comment. APHIS grants the petition only if it determines that
the plant poses no significant risk to other plants in the environment and is as
safe to use as more traditional varieties.
What does "determination of non-regulated status" mean?
This is a determination by APHIS that the new
plant should be treated like any other plant and, therefore, may be grown,
tested, or used for traditional crop breeding without any additional APHIS
action. Essentially, this determination permits the plant to be widely grown and
Does APHIS regulate other actions with biotechnology-derived plants?
Authorizations are also required for the movement
into the United States or between states of any genetically engineered organism
that is a potential plant pest. And, some developers of the very few biotech
plants that are not regulated by APHIS may seek a voluntary courtesy permit,
which may make it easier to move or field test the plant.
How widespread are biotech crops?
With APHIS approval, over 5,000 field trials have
been safely conducted since 1987. About 40 new agricultural products have
completed all the federal regulatory requirements (from all relevant agencies)
and may be sold commercially. They range from longer-lasting tomatoes to
According to the USDA's National Agricultural
Statistics Service (NASS), biotechnology
plantings as a percentage of total crop
plantings in the United States in 2004 were
about 46 percent for corn, 76 percent for
cotton, and 85 percent for soybeans. NASS
conducts an agricultural survey in all states in
June of each year. The report issued from the
survey contains a section specific to the major
biotechnology derived field crops and provides
additional detail on biotechnology plantings.
The most recent report may be viewed at the
For a summary of these data, see the USDA
Economic Research Service data feature at:
The USDA does not maintain data on
international usage of genetically engineered
crops. The independent International Service for
the Acquisition of Agri-biotech Applications (ISAAA),
a not-for-profit organization, estimates that
the global area of biotech crops for 2004 was
81.0 million hectares, grown by 8.25 million
farmers in 17 countries - a significant increase
over 2003 when 67.7 million hectares were grown
by 7.0 million farmers in 18 countries. The 2004
increase of 13.3 million hectares is the second
highest annual increase of biotech crops on
record. ISAAA reports various statistics on the
global adoption and plantings of biotechnology
derived crops. The ISAAA website is
What is the role of the EPA?
EPA approves new herbicidal and pesticidal
substances. EPA also issues permits for large scale testing of herbicides and
biotechnology-derived plants containing new pesticidal substances. In deciding
whether to register a new pesticide, EPA considers human safety, the fate of the
substance in the environment, the safety for humans, its effectiveness on the
target pest, and any effects on other, so-called "non-target" species.
What is the role of the FDA?
FDA ensures that foods derived from new plant
varieties are safe to eat, holding them to the same high standard of safety as
any more traditional food product.
Biotechnology and U.S. Agricultural
Trade Main Page