Order Code IB10131
CRS Issue Brief for Congress
Received through the CRS Web
Agricultural Biotechnology:
Overview and Selected Issues
Updated June 4, 2004
Geoffrey S. Becker
Resources, Science, and Industry Division
Congressional Research Service ˜ The Library of Congress

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CONTENTS
SUMMARY
MOST RECENT DEVELOPMENTS
BACKGROUND AND ANALYSIS
Adoption of Biotechnology in Agriculture
Current Applications
U.S. Food Products Containing GE Crops
Future GE Applications
“Input” Traits
“Output” Traits
Regulation and Oversight
Coordinated Framework for Regulation of Biotechnology
USDA’s Animal and Plant Health Inspection Service (APHIS)
Food and Drug Administration (FDA)
Environmental Protection Agency (EPA)
Assessments of Current Policy
Global Trade Concerns
Biotech Wheat
U.S.-EU Dispute
The Biosafety Protocol
GMOs in the Developing World
Other Selected Issues
Food Safety and Labeling
Environmental Concerns
Plant-Based Pharmaceuticals from Biotechnology
In Congress

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Agricultural Biotechnology: Overview and Selected Issues
SUMMARY
Since the first genetically engineered
which also are now taking effect, will con-
(GE) crops (also known as genetically modi-
tinue to discriminate against U.S. exports.
fied or GM crops) became commercially
Also, there is debate over whether agricultural
available in the mid-1990s, U.S. soybean,
biotechnology will improve (according to
cotton, and corn farmers have been rapidly
proponents) or undermine (according to oppo-
adopting them. As adoption has spread, the
nents) food security in developing countries.
policy debate over costs and benefits has
intensified.
In the 108th Congress, interest continues
in the trade impacts and regulation of agricul-
Issues include the impacts of GE crops
tural biotechnology. For example, the confer-
on the environment and food safety, and whe-
ence report to accompany the Consolidated
ther GE foods should be specially labeled.
Appropriations Act for FY2004 (H.Rept. 108-
Underlying these issues is the question of
401; P.L. 108-199) notes that $3.3 million is
whether U.S. regulation and oversight of
provided to USDA for “cross-cutting trade
biotechnology — with various responsibilities
negotiations and biotechnology resources.”
spread primarily among the U.S. Department
After the U.S. action against the EU morato-
of Agriculture (USDA), the Food and Drug
rium was filed, the Senate passed a resolution
Administration (FDA), and the Environmental
in support (S.Res. 154), on May 23, 2003. A
Protection Agency (EPA) — remain appropri-
similar House measure (H.Res. 252) was
ate, particularly as newer applications (e.g.,
passed on June 10, 2003. Pending bills by
biopharmaceuticals) emerge that did not exist
introduced by Representative Nick Smith
when the current regulatory regime was estab-
(H.R. 2447, H.R. 3472) would create an
lished. Relatedly, USDA’s Animal and Plant
interagency task force to promote the benefits
Health Inspection Service has been seeking
of agricultural biotechnology.
comments on its biotechnology oversight
regulations; on January 23, 2004, it published
On the other hand, a series of bills (H.R.
a notice of intent to prepare an environmental
2916, H.R. 2917, H.R. 2918, H.R. 2919, H.R.
impact statement evaluating its rules.
2920, H.R. 2921) introduced by Representa-
tive Kucinich would prescribe a variety of
Some U.S. agricultural export destina-
legislative changes intended to mandate label-
tions, notably the European Union (EU), have
ing of GE foods; broaden FDA oversight;
taken a more restrictive approach to regulating
protect producers from possible legal and
agricultural biotechnology than the United
environmental risks from agricultural biotech-
States, presenting obstacles for U.S. farm
nology; prohibit unapproved U.S. exports of
exports. Now before the World Trade Organi-
GE plants and animals; and tighten rules for
zation (WTO) is a U.S. complaint regarding
producing and handling GE pharmaceutical
the EU’s de facto moratorium, in place since
and industrial crops, among other things.
1998, on approvals of new GE crops. Even
though the EU says it has ended its morato-
Hearings on issues related to agricultural
rium (by approving in May a GE variety of
biotechnology were held in the House Agri-
canned sweet corn for import), U.S. agricul-
culture Committee on March 26 and June 17,
tural interests are concerned that new, stricter
2003. One of the panel’s subcommittees will
EU rules for labeling and tracing GE products,
hold a hearing on the topic on June 23, 2004.
Congressional Research Service ˜ The Library of Congress

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MOST RECENT DEVELOPMENTS
The biotechnology industry and those in U.S. agriculture who support it continue to face
challenges in winning acceptance of genetically modified organisms (GMOs). For example,
U.S. officials in March were pressing ahead with a challenge in the World Trade
Organization (WTO) to a longstanding moratorium in the European Union (EU) on
approvals of new GMO crops — even though EU authorities now claim that the moratorium
has ended with their approval, in May, of a GE variety of canned sweet corn imports. U.S.
agricultural groups also are urging the Administration to bring a separate WTO case against
the EU for what they say are its equally unfair and unworkable new rules for segregating and
labeling GM foods, feeds, and crops.
Market resistance may have contributed to a May 2004 decision by Monsanto to
discontinue efforts to win regulatory approval of a genetically modified wheat variety.
On the other hand, the Food and Agriculture Organization (FAO) of the United Nations
has given qualified support to agricultural biotechnology. FAO said in a May report that it
can benefit the poor if farmers in developing countries could gain more access to it to
complement other needed agricultural improvements.
At home, USDA’s Animal and Plant Health Inspection Service (APHIS) is reviewing
public comments it received on its January 23, 2004, Federal Register notice of intent to
prepare an environmental impact statement evaluating its biotechnology oversight
regulations. Observers expect that the agency could propose a number of potentially major
rule changes.
Congress continues to monitor closely all of these activities, and has passed resolutions
supporting U.S. international efforts on agricultural biotechnology. In the FY2004 USDA
appropriation, Congress increased funding both for U.S. international negotiations on
biotechnology and for the department’s office that regulates the field testing and
commercialization of new GM crops. The Administration’s FY2005 budget proposal
includes another increase for biotechnology regulation.
BACKGROUND AND ANALYSIS
Adoption of Biotechnology in Agriculture1
Farmers have always modified plants and animals to improve growth rates and yields,
create varieties resistant to pests and diseases, and infuse special nutritional or handling
characteristics. Such modifications have been achieved by crossbreeding plants and animals
with desirable traits, through hybridization and other methods.
1 Unless noted, sources for this issue brief include various materials by the U.S. Department of
Agriculture’s Economic Research Service and Animal and Plant Health Inspection Service, the Pew
Initiative on Food and Biotechnology; and the Biotechnology Industry Organization (BIO).
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Now, using recombinant DNA techniques, scientists can genetically modify plants and
animals by selecting individual genes that carry the desirable trait (e.g., resistance to a pest
or disease) from one organism, and inserting them into another, sometimes very different,
organism, that can be raised for food, fiber, pharmaceutical, or industrial uses.
Since genetically engineered (GE, sometimes called genetically modified or GM) crop
varieties first became commercially available in the mid-1990s, U.S. soybean, cotton, and
corn farmers have been rapidly adopting them in order to lower production costs and raise
crop yields. Proponents point to a so-called second generation of GE commodities that could
shift the focus of biotechnology from the “input” side (i.e., farm production benefits) to the
“output” side (i.e., consumer benefits), including products offering enhanced nutritional and
processing qualities, and industrial and pharmaceutical uses. Future products could be
livestock as well as crop-based. Critics, meanwhile, complain that biotechnology companies
generally have not yet delivered the consumer benefits they have been promising for years.
Nonetheless, the growth of biotechnology has spawned a number of public policy
questions. What are the environmental and food safety impacts of GE crops and animals?
What challenges and opportunities are exporters of GE crops finding in an increasingly
global marketplace? Is the current U.S. regulatory framework, which is based primarily upon
statutory authorities enacted before the rise of agricultural biotechnology, still adequate?
Current Applications
In 2003, GE crops were planted on an estimated 167 million acres worldwide. The total
number of countries growing such crops had reached 18 by 2003, but most of the acreage
was highly concentrated among four crops (soybeans, corn, cotton, and canola) and five
countries. Sixty-three percent of global acreage was in the United States; 21% was in
Argentina; and most of the rest was in Canada (6%), Brazil, and China (4% each).2
In the United States, about 60 GE versions of 13 different plants were approved by
APHIS for commercial use through early 2004, although most of the crops are not widely
planted.3 Three crops dominate. Eighty-six percent of all U.S. soybean, 76% of all upland
cotton, and 46% of all corn acres are expected to be planted with GE seed varieties in 2004,
according to USDA’s National Agricultural Statistics Service (NASS; see Table 1). U.S.
GE plantings continue to rise; 2003 acreages were 81% for soybeans, 73% for cotton, and
40% for corn. Almost all commercial applications are for production agriculture: weed and
insect control are by far the most widespread uses of GE crops here and abroad.
Herbicide-tolerant (HT) crops are engineered to tolerate herbicides that would
otherwise kill them along with the targeted weeds. These include so-called “Roundup
Ready” or HT soybeans, HT upland cotton, and to a lesser extent, HT corn.
2 International Service for the Acquisition of Agri-biotech Applications (ISAAA), Global Status of
Commercialized Transgenic Crops: 2003. For information on developments in Brazil, where GM
crops were planted illegally prior to 2003, see CRS Report RS21558, Genetically Engineered
Soybeans: Acceptance and Intellectual Property Rights Issues in South America.
3 Source: Information Systems for Biotechnology at Virginia Tech. Its website links to both U.S.
and international databases for field tests and approved GMOs; see [http://www.isb.vt.edu/].
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Insect-resistant crops effectively have the pesticide inserted into the plants themselves
to control insect pests for the life of the crop. Crops relying on Bt (Bacillus thuringiensis,
a soil bacterium) predominate. These insect-resistant varieties are most prevalent in upland
cotton to control tobacco budworm, bollworm, and pink bollworm; and corn to control
earworm and several types of corn borers.
Table 1. U.S. Acreage in Major GE Crops, 1996 and 2004 (Prospective)
Soybeans
Upland
Cotton
Corn
Million
Pct. of all
Million
Pct. of all
Million
Pct. of all
acres
soy acres
acres
cotton acres
acres
corn acres
1996
4.2
7%
2.2
17%
2.9
4%
2004
64.9
86%
10.8
76%
36.3
46%
Source: USDA-NASS, Prospective Plantings, various issues.
Other crops approved for commercialization include varieties of flax, papaya, potatoes,
radicchio, rapeseed, rice, squash, sugar beets, tobacco, and tomatoes. However, these are
either not on the market or not widely planted. In addition, several non-crop products are
available, notably in dairy production. Chymosin, a biotechnology-produced enzyme, is used
widely in cheese production. Bovine somatotropin (BST; also known as bovine growth
hormone) is a naturally occurring protein that can be produced in greater quantities through
genetic engineering. The GE version of BST was first approved by the U.S. Food and Drug
Administration (FDA) in 1993. More than 30% of all U.S. dairy cows are administered BST
to boost milk production (by an estimated 10%-15%).
U.S. Food Products Containing GE Crops4
Even though only 13 different GE plants have been approved for commercial use in the
United States, at least 60% of all U.S. foods likely contain some GE material. That is largely
because two such plants — corn and soybeans, where farmers have widely adopted GE
varieties — are used in many different processed foods. U.S. biotechnology rules do not
require segregation and labeling of GE crops and foods, so long as they are substantially
equivalent to those produced by more conventional methods (see “Regulation and
Oversight,” below).
Soy-based ingredients include oil, flour, lecithin and protein extracts; corn-based
ingredients include corn meal and corn syrups, used in many processed products. Canola oil
(mostly imported from Canada, where GE-canola is grown) and cottonseed oil are used in
cooking oils, salad dressings, snack foods, and other supermarket items. No GE-produced
animals are yet approved for human consumption, although cheeses may contain chymosin,
and dairy products may have been produced from milk containing GE-BST.
4 Sources include Cornell University, Genetically Engineered Organisms Public Issues Education
Project (GEO-PIE), website at [http://www.comm.cornell.edu/gmo/who.html]; and Colorado State
University’s Transgenic Crops: An Introduction and Resource Guide, at [http://www.colostate.edu/
programs/lifesciences/TransgenicCrops/index.html].
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Because most other government-approved GE crops are not being grown commercially,
few other GE-derived foods are reaching consumers. Possible exceptions are some zucchini
and yellow squash varieties, which few farmers are growing, and Hawaiian papayas, although
most U.S. papayas are non-GE imports from Brazil, Mexico, and the Caribbean. Calgene’s
FlavrSavr tomato, first marketed to consumers from 1995 to 1997, was withdrawn after
Calgene determined that the varieties being grown were not of consistently high quality. GE
potato varieties may have peaked several years ago at 2%-3% of the market, but were
discontinued by the seed developer in 2001 mainly after several fast food and snack food
companies declined to buy them. GE sugar beets, rice, flax, and radicchio have received
government approval but have not been commercially marketed, presumably due largely to
perceived producer or consumer unease with them.
Analysts say some farmers are wary of planting GE crop varieties because their
customers may be worried about their safety. Biotechnology supporters contend that such
concerns are unfounded because scientific evidence has found that GE crop varieties are safe,
and that foreign governments are simply using such concerns to maintain barriers to imports.
Future GE Applications5
“Input” Traits. For farmers, insect-resistant and herbicide-tolerant GE varieties are
under development for other crops, including wheat (see below), alfalfa, peanuts, sunflowers,
forestry products, sugarcane, apples, bananas, lettuce, strawberries, and eventually other
fruits and vegetables. Other traits being developed through genetic engineering include
drought and frost tolerance, enhanced photosynthesis, and more efficient use of nitrogen.
Tomatoes that can be grown in salty soils, and recreational turf grasses that are herbicide
tolerant, pest resistant, and/or more heat and drought tolerant also are under development.
“Output” Traits. For processors and consumers, a range of GE products may be on
the horizon, such as oilseeds low in saturated fats; tomatoes with anti-cancer agents; grains
with optimal levels of amino acids; rice with elevated iron levels; and rice with beta-
carotene, a precursor of Vitamin A (“golden” rice). Other future products could include
“low-calorie” sugar beets; strawberries and corn with higher sugar to improve flavor; colored
cotton; improved cotton fiber; delayed-ripening melons, strawberries, raspberries, and other
produce (such tomatoes already are approved); and naturally decaffeinated coffee. Critics
point out that biotechnology advocates have been forecasting the adoption of various
“output” traits for some time, but few are actually reaching the marketplace.
Plants being developed but not yet commercialized could become “factories” for
pharmaceutical compounds, to be extracted and purified for human and animal health uses
(among concerns are whether they could “contaminate” food crops; see “Plant-Based
Pharmaceuticals from Biotechnology” later in this report). Future transgenic livestock also
might yield pharmaceuticals and/or human organ and tissue replacements. Other transgenic
livestock traits might include more rapid growth, less fat, disease resistance, and longer
useful lives. Awaiting government approval are GE salmon that require as little as half the
usual time to grow to market size; other such fish could follow later.
5 Sources: ERS, Economic Issues in Agricultural Biotechnology (AIB-762), February 2001 (table,
page 19); BIO; and Colorado State University.
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Regulation and Oversight
Coordinated Framework for Regulation of Biotechnology
The basic federal guidance for regulating biotechnology products is the Coordinated
Framework for Regulation of Biotechnology (51 Fed. Reg. 23302), published in 1986 by the
White House Office of Science and Technology Policy (OSTP). A key principle is that
genetically engineered products should continue to be regulated according to their
characteristics and unique features, not according to their production method — that is,
whether or not they were created through biotechnology. The framework provides a
regulatory approach intended to ensure the safety of biotechnology research and products,
using existing statutory authority and previous agency experience with traditional breeding
techniques. The three lead agencies are USDA’s Animal and Plant Health Inspection Service
(APHIS), the Food and Drug Administration (FDA), and the Environmental Protection
Agency (EPA).
USDA’s Animal and Plant Health Inspection Service (APHIS). APHIS
regulates the importation, interstate movement, and field testing of GE plants and organisms
that are or might be plant pests under the Plant Protection Act (PPA; 7 U.S.C. §7701 et seq.).
APHIS regulates animal biologics (i.e., viruses, serums, toxins for animal vaccines) under
the Virus, Serum, and Toxins Act (21 U.S.C. 151 et seq.). Specifically, GE plants that are
or might be plant pests are considered “regulated articles” under APHIS regulations (7 CFR
340-340.9). APHIS authorization must be obtained prior to import, interstate movement, or
environmental release, including field testing.
More specifically, a “regulated” plant cannot be introduced into the environment —
even field tested — unless its developer obtains APHIS authorization through either the (1)
permit process or (2) notification process. Permits impose restrictions on movement and
planting to prevent escape of plant material that may post a pest risk. Sponsors follow
APHIS guidance on testing and movements to ensure that the plant will not damage
agriculture, human health, or the environment. Plant-based pharmaceuticals virtually always
must be developed under the permit process. However, most other GE crops have been
developed under the notification option, an expedited procedure that is less rigorous than
permitting. Notification can be used in lieu of permitting when the plant species is not
considered a noxious weed (or weed in the release area) and other APHIS standards are met.
Regardless of the process chosen, after testing is completed, a developer next seeks
“non-regulated status” from APHIS, the typical route to full commercialization and no
further formal oversight. The developer must provide APHIS with extensive information on
plant biology and genetics, and potential environmental and plant pest impacts that may
result from the modification. APHIS conducts a formal environmental assessment (EA) and
has public comment periods before deciding whether to approve the developer’s request for
“non-regulated status.”
Food and Drug Administration (FDA). FDA regulates food, animal feed additives,
and human and animal drugs, including those from biotechnology, primarily to ensure that
they pose no human health risks, mainly under the Federal Food, Drug and Cosmetic Act
(FFDCA; 21 U.S.C. §301 et seq.) and the Public Health Service Act (42 U.S.C. §201 et seq.).
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Under the FFDCA, all food and feed manufacturers must ensure that the domestic and
imported products they market are safe and properly labeled. All domestic and imported
foods and feeds, whether or not they are derived from GE crops, must meet the same
standards. Any food additive, including any introduced through biotechnology, cannot be
marketed before it receives FDA approval. However, additives that have been determined
to be “generally recognized as safe” (GRAS) do not need such preapproval.
To help sponsors of foods and feeds derived from GE crops comply, FDA encourages
them to participate in its voluntary consultation process. All GE-derived products now on
the U.S. market have gone through this process. With one exception, none of these foods
and feeds were considered to contain a food additive, and so they did not require approval
prior to marketing. However, a May 1992 FDA policy statement notes that GE foods must
undergo a special review under certain conditions, such as if the gene transfer produces
unexpected genetic effects, changes the nutrients or toxicant levels from the food’s
traditional variety, might contain an allergen from another crop, or would be used to host a
pharmaceutical or industrial substance, for example.6
Environmental Protection Agency (EPA). EPA must approve the use of all
pesticides, including those genetically engineered into plants, which it terms “plant-
incorporated protectants” (PIPs). EPA essentially determines a PIP’s environmental safety
through its authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA;
7 U.S.C. §136 et seq.). Also, under the FFDCA, the EPA establishes tolerances (i.e., safe
levels) for pesticides in foods. Pre-commercial regulation is through a system of
notifications for small-scale field tests or Experimental Use Permits for larger field tests. As
for any pesticide, EPA requires the manufacturer of a PIP to obtain a registration through a
regulatory process intended to ensure its safe use environmentally.
In practice, all three agencies have more detailed procedures than those described above
for monitoring and approving the development and commercialization of GE crops and
foods, particularly if they are for new uses (e.g., pharmaceuticals). However, the fundamental
policy assumption since 1986 has been that the biotechnology process poses no unique or
special risks; therefore it demands no new laws beyond those that already govern the health,
safety, efficacy, and environmental impacts of more traditional production methods.
Assessments of Current Policy
The biotechnology industry, leading U.S. agricultural groups, and many scientific
authorities continue to subscribe to this longstanding U.S. policy approach. They cite various
studies in asserting that there is no evidence that current GE crops have harmed the
environment or human health. These studies include the National Academy of Sciences/
National Research Council (NAS/NRC) 2002 report Environmental Effects of Transgenic
Plants: The Scope and Adequacy of Regulation; the NAS/NRC 2000 report Genetically
Modified Pest-Protected Plants: Science and Regulation; the Council for Agricultural
Science and Technology (CAST) 2001 report Evaluation of the U.S. Regulatory Process for
Crops Developed Through Biotechnology and the CAST 2002 report Comparative
6 See the FDA biotechnology website at [http://www.cfsan.fda.gov/~lrd/biocon.html#policy]; and
CRS Report RL30198, Food Biotechnology in the United States: Science, Regulation, and Issues.
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Environmental Impacts of Biotechnology-derived and Traditional Soybean, Corn, and
Cotton Crops.
While these reports generally conclude that current GE crops likely pose no greater risks
than conventional varieties, they have suggested a number of administrative or regulatory
changes that might be adopted to improve oversight. Critics have gone further, raising
questions about whether the current laws themselves remain adequate to protect human
health and the environment, particularly as emerging GE applications — such as plant-based
pharmaceuticals and industrial compounds, and transgenic animals, including insects —
increasingly challenge the agencies’ regulatory capabilities. They see gaps in the existing
pre-market approval processes, and in post-market oversight of GE crops, that they contend
may expose humans and the environment to unwarranted risks. These critics believe that
only new legislation can clarify agency roles and strengthen their regulatory authority,
particularly over future novel GE applications. (For additional discussion, see “Food Safety
and Labeling” and “Environmental Concerns” under “Other Selected Issues.”)
A number of agricultural organizations, while not necessarily clamoring for new laws,
have expressed wariness about some new biotechnology products now awaiting approval.
Among other concerns, they worry about consumer acceptance, potential difficulties
exporting these varieties to countries demanding the segregation and labeling of GMOs (or
their outright prohibition), and the potential for inadvertently mixing GE with non-GE crops.
A related question is how to assess liability if such mixing does occur, or if GE plants prove
harmful to the environment. For example, to what extent if any should biotechnology
companies share liability with producers and others who use their products?
All sides of the debate appear to agree that whatever policy course is pursued in the
future, it should provide for a clear, predictable, trusted regulatory process.7
Utilizing its current legislative authorities, APHIS has taken a number of actions over
the past several years intended to improve regulatory oversight. These have included
consolidation of its activities under a new Biotechnology Regulatory Services office;
development of a compliance and enforcement unit to ensure GE developers’ adherence to
the rules, and, in 2003, the publication of more stringent permit conditions for GE-derived
plants for pharmaceuticals and industrials (see “Plant-Based Pharmaceuticals from
Biotechnology,” below). USDA also increased its oversight budget for FY2004 and is
requesting a further FY2005 increase from Congress.
More recently, APHIS announced that it is considering whether to overhaul its existing
biotechnology regulations. In the January 23, 2004, Federal Register, the agency published
a notice of its intent to prepare an environmental impact statement evaluating these
regulations, and requesting public comments (accepted through April 13, 2004) on a number
of possible changes. These include whether to broaden APHIS’s regulatory scope to cover
GE plants that may pose a noxious weed risk or that may be used as biological control
agents; whether to establish new categories for field testing that delineate requirements based
upon relative levels of potential risk; and whether to change (e.g., strengthen) its
7 The various arguments are explored at length in an April 2004 Pew Initiative report, Issues in the
Regulation of Genetically Engineered Plants and Animals. See [http://pewagbiotech.org/].
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environmental reviews and permit conditions for GE plants for pharmaceuticals and
industrials, and differentiate between food and non-food crops for these products. APHIS
also solicited comments on ways that it might ease its requirements for lower-risk products.
Global Trade Concerns
The U.S. approach to agricultural biotechnology regulation contrasts with that of many
major trading partners. For example, the European Union (EU), Japan, South Korea, China,
New Zealand, and Australia either have or are establishing separate mandatory labeling
requirements for products containing genetically modified ingredients; in many of these
countries, consumer and official attitudes toward GE foods are more skeptical. Differing
regulatory approaches have arisen at least partly because widely accepted international
standards are still evolving. Meanwhile, some U.S. exports have been disrupted and trade
tensions have grown, as discussed below.8
Biotech Wheat
Such concerns have been crystalized by the prospective introduction of a GE variety of
herbicide-tolerant wheat. Monsanto had asked the U.S. and Canadian governments for their
approval, and other GE wheat varieties also have been under development. Some producers
want to plant the wheat when it becomes available; others fear rejection by foreign customers
of not only GE wheat, but all U.S. and Canadian wheat, out of concern that even non-GE
shipments might unintentionally contain some GE grain. The latter group wants developers
and regulators to wait for more market acceptance before releasing GE wheat varieties.
Market resistance likely contributed to a decision by St. Louis-based Monsanto to
discontinue its efforts to win regulatory approval of a genetically modified wheat variety.
Monsanto announced its decision on May 10, 2004, noting that after a portfolio review and
“dialogue with wheat industry leaders, we recognize the business opportunities with
Roundup Ready spring wheat are less attractive relative to Monsanto’s other commercial
priorities.”
In early 2003, a group of U.S. wheat producers had petitioned the Administration to
conduct a more thorough assessment of the environmental impacts of the Monsanto request;
27 farm, religious, and consumer advocacy organizations endorsed the petition in early 2004.
Underlining these concerns, Japanese consumer groups in March 2004 reportedly told U.S.
8 See also CRS Report RL31970, U.S. Agricultural Biotechnology in Global Markets: An
Introduction. This issue brief does not discuss the trade challenges encountered by the
biotechnology companies themselves. Among other problems, besides foreign resistance to
agricultural biotechnology in general, these companies also face often divergent laws on
international property rights (IPR), where their patent or plant breeding rights in one country may
be nonexistent in another. In the developing world in particular, the policy challenge is to find a
balance between companies’ IPR and the ability to use the new technologies. For details, see
International Food Policy Research Institute, Biotechnology and Genetic Resource Policies, Briefs
1-6, January 2003; CRS Report RL31568, Plants, Patents, and Seed Innovation in the Agricultural
Industry; and CRS Report RL31132, Multinational Patent Acquisition and Enforcement: Public
Policy Challenges and Opportunities for Innovative Firms.
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officials in wheat-dependent North Dakota that their country would not import any U.S.
wheat products if the Monsanto application was approved.9
U.S.-EU Dispute
Another controversial trade case is the U.S. complaint against the EU’s de facto
moratorium, in place since 1998, on approvals of new GE crops. In May 2003, the United
States, Canada, and Argentina initiated a case before the World Trade Organization (WTO).
U.S. agricultural interests contend that the moratorium not only has blocked exports such as
corn and other products to the EU, but also has fueled unwarranted concerns about the safety
of agricultural biotechnology throughout the world. The United States and its allies argue
that the EU moratorium violates WTO rules stating that a country’s actions to protect health
and the environment must be scientifically based, and approval procedures must be operated
without undue delay. The WTO named a panel on March 4, 2004, to consider the case; their
decision is expected later this year.
EU officials have told the United States that their cautious approach to regulating
agricultural biotechnology is necessary to restore confidence among European consumers,
who have become much more wary of changes in how their food is produced, particularly
after a series of major food safety crises there that were not related to GE crops. At the same
time, EU officials assert that they have shown good faith in moving as quickly as possible
to restart the approval process. On January 28, the European Commission, the EU executive
body, took steps that it said soon would lead to the approval of the first new GM products.
Subsequently, in May 2004, the Commission approved a GE variety of canned sweet corn
for import. Some U.S. interests countered that the moratorium will not effectively end until
the EU clears several more of some 30 GE food and agricultural products still awaiting
regulatory approval — and EU member states actually implement the approvals.
Also, the current case does not involve the EU’s new regulations, also now taking
effect) to require most food, feed, and processed products from genetically modified GMOs
to be labeled, even if they no longer contain detectable traces of GM material (meat and
livestock products generally are exempt). GE-based products also must be segregated from
non-GE products, with documentation. U.S. agricultural interests argue that, even if and
when the moratorium is lifted, the new labeling and traceability rules are themselves
unworkable and unnecessary, and can mislead consumers by wrongly implying that
GM-derived products are inherently different than non-GM foods or pose safety concerns.10
The Biosafety Protocol
The Cartagena Biosafety Protocol, an outgrowth of the 1992 Convention on Biological
Diversity (CBD), was adopted in January 2000 and took effect in 2003. The United States
is not a party to the 1992 CBD, and therefore cannot be a party to the protocol. However,
because its shipments to ratifying countries will be affected, it has actively participated in the
negotiations over the protocol text and in countries’ preparations for implementation.
9 Sources include Food Chemical News, various issues; Cornell University GEO-PIE; and several
news wire service reports.
10 See CRS Report RS21556, Agricultural Biotechnology: The U.S.-EU Dispute.
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The protocol, which nearly 90 countries have ratified, permits a country to require
formal prior notifications from countries exporting biotech seeds and living modified
organisms (LMOs) intended for introduction into the environment. The protocol requires
that shipments of products that may contain LMOs, such as bulk grains, be appropriately
labeled and documented, and provides for an international clearinghouse for the exchange
of LMO information, among other provisions. The United States objects to implementing
measures, approved during an international conference in Kuala Lumpur in February 2004,
that would mandate what it says are overly detailed documentation requirements and that
would potentially expose exporters to unwarranted liability damages if imported GMOs harm
the environment or human health. These and other rules could disrupt U.S. exports, U.S.
government and industry officials believe.11
GMOs in the Developing World
In 2002, the United Nations (UN) World Food Program (WFP) announced an appeal
for food aid to meet the needs of some 14 million food-short people in six southern African
countries, Lesotho, Malawi, Mozambique, Swaziland, Zambia, and Zimbabwe. However,
a debate over the presence of genetically modified corn in U.S. food aid shipments made the
provision of food aid more difficult and costly. Some of the countries expressed reluctance
to accept unmilled GE corn on account of perceived environmental and commercial risks
associated with potential introduction of GE seeds into southern African agriculture. Zambia
refused all shipments of food aid with GE corn out of health concerns as well. In late March
2004, Angola said it too would ban imports of GE food aid, including thousands of tons of
U.S. corn, despite a need to feed approximately 2 million food-short people there.
The United States has blamed EU policies for southern African countries’ views on
food aid containing GE products. President Bush, for example, has stated that EU
governments, because of their policies on GE products, are hindering the cause of ending
hunger in Africa. The United States maintains that genetically modified crops are safe to eat
and that there is little likelihood of GE corn entering the food supply of African countries for
several reasons, including the fact that bioengineered varieties of corn are not well adapted
to African growing conditions.
Also, there is debate over the potential contribution of biotechnology to food security
and agricultural development in developing countries. Critics of biotechnology argue that
the benefits of biotechnology in developing countries have not been established and that the
technology poses unacceptable risks or problems for developing countries’ agriculture.
Critics suggest that intellectual property rights (IPR) protection impedes development and
dissemination of GE crops in developing countries and also gives multinational companies
control over developing country farmers. Proponents, however, say that the development of
GE technology appears to hold great promise, with the potential to complement other, more
traditional research methods, as the new driving force for sustained agricultural productivity
in the 21st century. They maintain that IPR difficulties have been exaggerated.
11 Sources include CRS Report RL30954, Biosafety Protocol for Genetically Modified Organisms:
Overview; and various USDA and U.S. State Department background materials on the protocol.
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The UN’s Food and Agriculture Organization (FAO) recently gave a qualified
endorsement of agricultural biotechnology in The State of Food and Agriculture 2003-2004.
FAO said that biotechnology including genetic engineering “can benefit the poor when
appropriate innovations are developed and when poor farmers in poor countries have access
to them on profitable terms. Thus far, these conditions are only being met in a handful of
developing countries.” Biotechnology research and development should complement other
agricultural improvements that give priority to the problems of the poor, and the public sector
should direct more resources to such improvements, FAO said, adding: “Regulatory
procedures should be strengthened and rationalized to ensure that the environment and public
health are protected and that the process is transparent, predictable and science-based.”
Other Selected Issues
Food Safety and Labeling
Many consumers may be wary of GE foods out of fear that introduced genes could
prove allergenic, introduce increased toxicity, or otherwise be harmful to human health.
Some critics express concern that FDA is placing all the responsibility on manufacturers to
generate safety data, as it does normally under its pre-market approval system, and is
reviewing only the conclusions of industry-sponsored studies, rather than conducting its own
tests. They also believe that the process lacks transparency and adequate public scrutiny of
data. Others defend the current system. They counter that additional testing and oversight
are unnecessary because all foods must meet the same rigorous federal safety standards
regardless of whether or not they are genetically engineered.
U.S. policy also does not require GE-derived foods to be so labeled as long as they are
substantially the same as their more conventional counterparts. Nonetheless, some consumer
groups continue to seek mandatory labeling of all GE foods. These groups argue that U.S.
consumers, like their EU counterparts, should have an opportunity to see all relevant
information on a label so that they can make food choices based on their own views about
its perceived quality or safety. The food industry generally opposes compulsory biotech
labeling. One of its concerns is that consumers might interpret GE labels as “warning labels”
implying that the foods are less safe or nutritious than conventional foods, even though the
preponderance of science indicates otherwise. The industry also has pointed out that
mandatory labeling would require development of a costly and possibly unattainable system
to ensure that GE and non-GE foods remain segregated from the farm to the store, with no
added benefit to the consumer. The industry has asserted that if consumers want to purchase
GE-free products, the market will support a voluntary system, as exists for organic foods
(where rules already prohibit GE foods to carry the “organic” label).
A closely related issue is the so-called adventitious presence (AP) of GE material in
non-GE crops. In general terms, AP refers to any incidental appearance of very small
amounts of foreign material in a commodity, which can occur at any time during production,
harvesting, storage, or marketing. In the grain business, even shipments of the highest grades
are permitted to contain some specified low levels of unwanted material, such as weeds,
damaged kernels, and/or stems and leaves. Corn graded No. 1, for example, may contain up
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to 2% foreign material. As more crops and acreage are devoted to GE varieties, it becomes
increasingly difficult, if not impossible, to avoid their trace presence in non-GE varieties.
Moreover, no internationally recognized standards exist for what amounts, if any, of AP
GE material should be permitted in a non-GE crop, especially if that crop or a food derived
from it will be labeled as non-GE. In the absence of such standards, individual countries are
establishing their own, often varying, thresholds. The lack of consistent, scientifically sound
standards is confusing consumers and disrupting trade, the biotech industry has asserted. For
example, the new EU regulation sets a tolerance level for non-GE foods, feeds, and
processed products at 0.9%. All products with more than 0.9% must be labeled as GM. U.S.
agricultural interests consider the EU regulation in particular to be unworkable and
discriminatory. EU officials counter that their standards not only are reasonable but also
are being demanded by consumers. (See also “U.S.-EU Dispute,” above.)
In its January 23 notice, APHIS asked for comments on if, and how, its regulations
should address the AP question for GE plant material. Questions include whether such
presence should be exempt from regulation, what thresholds (levels) of AP might be
acceptable, and under what conditions.
Environmental Concerns
Supporters of biotechnology claim that GE crops offer environmental advantages over
conventionally produced organisms. They note that the technology is more precise than
traditional methods like crossbreeding. The latter methods transfer unwanted and
unanticipated characteristics along with the desired new traits from one organism to another.
Biotechnology also has made it possible to apply fewer and less toxic chemical herbicides
and insecticides and to reduce soil tillage (thereby decreasing erosion and improving soil
fertility), supporters of the technology assert.
Critics counter that genetic engineering is not like traditional breeding. It creates crop
and animal varieties that would not otherwise occur in nature, posing unpredictable risks to
the environment (and to human health), they point out. Because they are living organisms,
GE crops are difficult to control, greatly increasing the potential for escaping into the
environment, crossbreeding with and overtaking wild species, and generally disrupting the
natural ecosystem, critics believe. For example, GE, herbicide-tolerant seeds or pollen could
inadvertently create “superweeds” that out-compete cultivated or wild plants, critics argue.
A 2002 NAS/NRC report stated that it could find no new distinctions between the types
of environmental risks posed by GE plants and those posed by more conventionally bred
crops (and that, in fact, there is a need to re-evaluate the potential environmental effects of
the latter). The study concluded that the current APHIS regulatory system for biotechnology
has improved substantially since it was first initiated and is more rigorous than the
environmental oversight for other agricultural products and practices. The study did find
areas of concern, including the need for greater transparency and public input into the
regulatory process, and for more ecological monitoring after GE plants are approved and
enter the marketplace.
A more recent NAS/NRC report cited studies to conclude that some GE organisms are
viable in natural ecosystems and can breed with wild relatives. The report urged developers
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of GE organisms to consider biological techniques such as induced sterility in order to
prevent transgenic plants and animals from escaping into the environment. “Because no
single bioconfinement method is likely to be 100% effective,” and because few are well-
developed, such developers should create a redundant system by using more than one method
of containment. The report called for more research to improve both containment methods
and public confidence in regulation.12
Plant-Based Pharmaceuticals from Biotechnology
Worldwide, hundreds of GE plants are under development for use as “factories” for
pharmaceuticals (and other industrial compounds). GE pharmaceuticals might include, for
example, vaccines or medicines for forms of cancer, infectious diseases, cardiovascular and
nervous system diseases, metabolic disorders, and agents of biowarfare. Proponents believe
plant-based pharmaceuticals will provide a far more cost-effective alternative to conventional
pharmaceutical production, which now requires major investments both in large volumes of
purified culture mediums and in manufacturing plants. Plant-based pharmaceuticals, on the
other hand, could be easily incorporated into the existing agricultural infrastructure,
providing a significant new source of farm income, they believe.13
However, critics are concerned about impacts on the food supply if food crops like corn
(the most widely planted U.S. crop, an intensively researched plant for biotechnology, and
also an airborne pollinator) are “pharmed.” In 2002, for example, material from GE-altered
corn plants that had been test-planted in a prior growing season in Nebraska for
pharmaceutical use (for ProdiGene, Inc.) was inadvertently mixed with some 500,000
bushels of soybeans, which had to be quarantined by USDA to keep them out of the food
supply. USDA officials observed that the soybeans never reached the food or feed supply,
evidence that current regulatory oversight is effective.
Nonetheless, concerns persist among both consumer groups and the food manufacturing
industry about producing GE plant-made pharmaceuticals in food crops. Some want 100%
prevention systems in place before the first product is commercialized. Some of these groups
suggest that only non-food crops should be used for GE plant-made pharmaceuticals, or that,
at a minimum, pharmaceutical crops should be banned from agricultural areas where food
and feed crops are produced. Other potential issues include whether manufacturers of plant-
based pharmaceuticals will be able to maintain consistency in dosages and overall quality,
and unanticipated environmental problems (e.g., threatening endangered species).14
12 NAS/NRC, respectively, Environmental Effects of Transgenic Plants: The Scope and Adequacy
of Regulation, 2002; and Biological Confinement of Genetically Engineered Organisms, 2004.
Among numerous other studies that examine environmental impacts and the adequacy of regulation
are Council for Agricultural Science and Technology, Comparative Environmental Impacts of
Biotechnology-derived and Traditional Soybean, Corn, and Cotton Crops, June 2002; and Pew
Initiative on Food and Biotechnology, Post-Market Oversight of Biotech Foods — Is the System
Prepared? (prepared for Pew by Resources for the Future), April 2003.
13 Also see CRS Report RS21418, Regulation of Plant-Based Pharmaceuticals.
14 The 2004 NAS/NRC report observed that an organism widely used for food “probably would be
a poor choice as a precursor for an industrial compound” unless it were strictly confined. Alternative
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Responding to such concerns, APHIS published in the March 10, 2003, Federal
Register a notice tightening permit conditions for its 2003 field tests of GE plants with
pharmaceutical and industrial traits. The changes included (1) doubling the minimum
distance allowed between traditional corn fields and test sites of pharmaceutical or industrial
corn; (2) for all pharmaceutical crops (corn and other), doubling fallow zones around test
sites; (3) restricting what can be grown on a test site and fallow zone in the next growing
season; (4) using dedicated machinery (e.g., harvesters, planters) and storage facilities only
for pharmaceutical production — adequate cleaning for other uses is no longer acceptable;
(5) sumitting for APHIS approval equipment cleaning and seed cleaning and drying
procedures; (6) increasing APHIS field site inspections from one per season to five per
season plus two visits the following year to look for any volunteer plants; (7) more record-
keeping and training requirements. APHIS issued a letter on January 14, 2004, aimed at
clarifying and updating its previous guidance on permits.
In Congress
In the 107th Congress, lawmakers included both in the 2002 farm law (P.L. 107-171) and
in trade promotion legislation (P.L. 107-210) provisions aimed at supporting use of GE farm
products, including new programs to challenge foreign barriers to U.S. exports of such
products and to educate the public on GE-based foods. In the 108th Congress, the conference
report to accompany the Consolidated Appropriations Act for FY2004 (H.Rept. 108-401;
P.L. 108-199) notes that $3.3 million is provided to USDA for “cross-cutting trade
negotiations and biotechnology resources.” The measure also includes approximately $5
million for APHIS’s office of Biotechnology Regulatory Services.
After the Administration launched its formal challenge of the EU GM moratorium, the
Senate on May 23, 2003, passed by unanimous consent a resolution (S.Res. 154) in support
of the action. A similar House measure (H.Res. 252) was passed on June 10, 2003, by a
suspension vote of 339-80. Pending are bills by Representative Nick Smith (H.R. 2447, H.R.
3472) to create an interagency task force to promote the benefits of agricultural
biotechnology.
A more wary approach is reflected in a series of bills introduced by Representative
Kucinich. His bills (H.R. 2916, H.R. 2917, H.R. 2918, H.R. 2919, H.R. 2920, H.R. 2921)
would prescribe a variety of legislative changes intended to mandate labeling of GE-based
foods, broaden FDA oversight, protect producers from any potential legal and environmental
risks from agricultural biotechnology, prohibit unapproved U.S. exports of GE plants and
animals, and tighten rules for producing and handling GE pharmaceutical and industrial
crops, among other things.
A hearing on biotechnology is scheduled for June 23, 2004, before a subcommittee of
the House Agriculture Committee. The Committee had held hearings on the topic on March
26 and June 17, 2003.
14 (...continued)
nonfood host organisms should be sought, the report concluded.
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