Biotechnology
in the United States
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This
page was developed to provide information on issues in biotechnology at a
national level. This page covers:
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Each section begins with a brief summary and
is followed by links to
relevant articles and other websites providing more detailed
information.
History
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Genetic engineering became
a possibility with the discovery in the early 1970s of a method to extract
genes and insert them into another organism’s DNA. The combined work of
Herbert Boyer at the
University of California at San Francisco and Stanley Cohen at Stanford,
led to the creation in 1978 of the first transgenic
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organism, an E. Coli
bacterium with the human insulin gene. The 1982 development of the Polymerase
Chain Reaction (PCR) enabled scientists to multiply gene sequences in vitro,
and greatly stimulated research.
By 1985,
field testing of genetically engineered plants resistant to
insects, viruses, and bacteria was underway. Only a year later, the EPA
approved the release of the first genetically modified crop,
herbicide-resistant tobacco. In the same year, scientists developed
herbicide-resistant soybeans, which were to become the single most
important GM crop by the mid-1990s.
In 1987,
Calgene, Inc. patented a DNA sequence that extended the shelf life of
tomatoes. Calgene conducted the first field trials of
herbicide-resistant cotton in 1990. That year also saw the much publicized
creation of the first transgenic dairy cow by GenPharm
International. For the consumer, 1990 marked the initiation of
biotech foods, with the sale of a cheese made using GM
microorganisms.
With growing
public awareness of biotechnology, the US government
began to play an increasingly visible role in regulating biotechnology. In
response to consumer concern, in 1993, the FDA stated that genetically
engineered foods did not require special regulation, as they were “not
inherently dangerous.” That was followed in 1994 by FDA approval of the
first GM crop, the Flavr Savr tomato, a Calgene product. In 1996, the
sale of herbicide-resistant soybeans was permitted in the US.
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This information was
gathered from the following two websites:
“A Brief History of
Food” in Food Biotechnology Teaching Guide
A University of Kentucky Cooperative
Extension Publication
http://www.ca.uky.edu/agc/pubs/brei/brei3tg/brei3tg.htm
Timeline of US
Biotech, from Access Excellence http://www.accessexcellence.org/AB/BC/1977-Present.html
Other sites with information on the development of
agricultural biotechnology:
A Timeline of Biotechnology, from BIO
http://www.bio.org/timeline/timeline.html
Rhizobium Meliloti
Field Tests
Interesting report on field trials
of GMOs http://www.accessexcellence.org/AB/BA/Rhizobium_Meliloti_
Tests.html
FDA’s Review Process
for the Flavr Savr Tomato http://vm.cfasn.fda.gov/~lrd/biotechn.html
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The USDA
has approved more than 50 bio-engineered crops by for use by farmers,
including corn, tomato, soybean, cotton, potato, rapeseed (canola), squash,
beets, papaya, rice, flax, and chicory. In 1999, 36% of the corn, 55% of
the soybean, and 60% of the cotton grown in the US were from bio-engineered
varieties.
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The American consumer now finds these GM crops
in thousands of processed foods. Delayed-ripening tomatoes stay fresh longer
in the supermarket, and soybeans with reduced levels of saturated fat produce
healthier cooking oils. Herbicide-resistant corn is an ingredient in many
prepared foods.
Many more transgenic crops are in the process
of being developed. Researchers are attempting to develop a corn cultivar
resistant to corn rootworm, one of the most serious corn pests. Improved
nutrition is also a major area of research. Scientists are currently
investigating the possibility of increasing Vitamin A in tomatoes and rice,
and Vitamin E in canola. Bananas are being investigated as a vehicle for
vaccines against infectious diseases. Environmental concerns over turfgrass
management have led to the search for genes that would reduce growth rate,
improve drought tolerance, and improve pest resistance.
As a mandated part of the approval process,
transgenic crops undergo field testing. In 2001, there were about 13,000
field tests in the United States, with each test often involving multiple
sites.
There are currently 455 agricultural
biotechnology companies in the United States. Most research institutions are
internally regulated by institutional biosafety committees which enforce
safety standards in biological research.
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This information was
gathered from the following websites:
Acreage data on
biotech crops, 1999
Lists acreage and percentage of US market in 1999 of corn, cotton,
soybeans, potatoes,canola
http://www.bio.org/food&ag/1999Acreage.html
Crops no longer regulated by the USDA
Search by organism, institution, phenotype,
date range.
http://www.nbiap.vt.edu/cfdocs/biopetitions1.cfm
Ag biotech products on the market
Describes trait, gene, company, year for each
product
http://www.bio.org/food&ag/approvedag98.html
Transgenic products
on the market
Describes beneficial product traits by crop.
http://www.bio.org/food&ag/transgenic_products.html
Charts of field test
release locations in US
recorded by state, &
searchable by year (or to date)
http://www.nbiap.vt.edu/cfdocs/biocharts1.cfm
Field tests of GMOs
by state
Step1: select all field tests
Step 2: select location
www.nbiap.vt.edu/cfdocs/fieldtests1.cfm
Future Transgenic
Products http://www.colostate.edu/programs/lifesciences/TransgenicCrops
/future_page.html
Agricultural Biotech
Companies
Searchable by company name, state, or
classification (eg plant ag,
animal ag, aquaculture)
http://www.nbiap.vt.edu/cfdocs/companies1.cfm
Institutional
Biosafety Committees
Searchable by state or institution
http://www.nbiap.vt.edu/cfdocs/ibcs1.cfm
Other links with
current information
Biotech centers in
US
educational, organizations, industry,
can search by region or state.
http://www.bio-link.org/centers.htm
US National Policy
on Biotechnology
(from AgBioTech Net)
links to news reports on nat’l policies
on biotech
http://www.biotech-info.net/policy.html#national
State Policies on
Biotechnology
(from AgBioTech Net)
links to news reports on state policies
on biotech
http://www.biotech-info.net/policy.html#state
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Regulation:
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Regulation
of bio-engineered food crops in the United States is a joint effort of the
United States Department of Agriculture (USDA), the Environmental
Protection Agency EPA), and the Food and Drug Administration (FDA). Each
agency is responsible for a different part of the review process. The USDA
has primary responsibility for determining if a new
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product is safe to grow,
while the EPA reviews the product for potential impact on the environment.
The FDA meanwhile is concerned with protecting the consumer and has final
authority to declare if a product is safe to eat. To date, approximately 50
bio-engineered food crops have been approved through this process, and have
found their way into thousands of processed foods.
Since biotechnology is still a relatively
new technology, there is much debate as to the adequacy of the current
regulatory process. Various committees and independent authors have reviewed
the process and made recommendations for improvement. Currently, the US
determines the level of testing required through an assessment of a new
crop's "substantial equivalence" with a pre-existing crop. This
approach requires less rigorous testing than the European system, which
examines each product for risks.
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This information was
gathered from the following websites:
The US Regulatory
Oversight in Biotechnology webpage:
A clear chart of the division of
responsibility in the regulatory process
http://www.aphis.usda.biotech/OECD/usregs.htm
The US Department of
State:
A comprehensive fact sheet (5 pp) describes the process of regulation.
http://usinfo.state.gov/topical/global/biotech/00080901.htm
Other links with
regulatory information:
Breeding Distrust: An Assessment and Recommendations
for Improving the Regulation of Plant Derived Genetically Modified Foods
By the Consumer Federation of America
http://www.biotech-info.net/Breeding_Distrust.html
“Genetically
Modified Pest-Protected Plants: Science and Regulation”
Report of Committee on Genetically
Modified Pest-Protected Plants,
National Research Council, calling for changes in regulatory process.
http://books.nap.edu/catalog/9795.html
“Biosafety
Regulation”
Chapter 2 in Transgenic Crops
Compares US and EU Regulatory Approaches.
http://www.winrock.org/Transgenic.pdf
USDA Biotechnology
Site
Official USDA site, provides a
description of laws and process.
http://www.aphis.usda.gov/biotechnology
USDA policy news
Interesting news and reports.
http://www.biotech-info.net/policy.html#usda
EPA
Describes the
3 statutes under which the EPA regulates BT products.
http://www.epa.gov/scipoly/oscpbiotech.htm
EPA Policy News
News and media reports.
http://www.biotech-info.net/policy.html#epa
Comments on EPA
Policy
Other viewpoints on EPA decisions.
http://www.biotech-info.net/EPA_comments.html
FDA
http://vm.cfsan.fda.gov/~lrd/biotech.html
List of links to FDA reports, policies
on biotechnology.
FDA’s Statement of
Policy; Food Derived From New Plant Varieties
http://vm.cfsan.fda.gov/~lrd/bioqa.html
FDA’s Policy on
Genetically Modified Food, Slide Presentation http://vm.cfsan.fda.gov/~comm/afdo2k.html
FDA Policy news
News and media coverage.
http://www.biotech-info.net/policy.html#fda
FDA Hearings and
Testimony
http://www.biotech-info.net/FDA_hearings.html
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Concerned
Groups:
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Although the majority of American consumers are more accepting of
biotechnology products than their European counterparts, much unease and
outright opposition exists to the use of biotechnology. Concerns range from
environmental safety to human health to ethics. There are several groups that
are lobbying for mandatory labeling of food containing genetically modified
products. It is not the intention of this site to promote any
viewpoint. We provide here a listing of admittedly anti-biotechnology
sites, for the fair representation of American attitudes.
Breeding Distrust: An Assessment and
Recommendations for Improving the Regulation of Plant Derived genetically
Modified Foods.
Report of Food policy Institute,
Consumer Federation of America, 2001
http://www.biotech-info.net/Breeding_Distrust.html
Keep Nature Natural
A campaign for labeling of genetically
engineered food.
http://www.keepnatural.org/
Genetic
Engineering and its Dangers
Compiled by Dr. Ron Epstein, San Francisco State University.
http://online.sfsu.edu/%7Erone/GE%20Essays/gedanger.htm
Greenpeace
biotechnology site
http://www.greenpeace.org/~geneng/
The Campaign to
Label Genetically Engineered Food http://www.thecampaign.org/
The Center for Food
Safety
Aims to ensure testing and regulation
of genetically modified foods.
http://www.centerforfoodsafety.org/
The Council for
Responsible Genetics
non-profit,
non-governmental organization dedicated to fostering public debate about new
genetic technologies.
http://www.gene-watch.org/
Biotechcentury.org
A
project of the Foundation on Economic Trends.
http://www.biotechcentury.org/current.html
Genetic Engineering and Intellectual Property
Rights Resource Center
Lists of concerned organizations,
events, and resources
http://www.sustain.org/biotech/
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