Order Code RL32809
CRS Report for Congress
Received through the CRS Web
Agricultural Biotechnology:
Background and Recent Issues
March 7, 2005
Geoffrey S. Becker
Specialist in Agricultural Policy
Resources, Science, and Industry Division
Congressional Research Service ˜ The Library of Congress

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Agricultural Biotechnology:
Background and Recent Issues
Summary
Since the first genetically engineered (GE) crops (also called GM [genetically
modified] crops, or GMOs, genetically modified organisms) became commercially
available in the mid-1990s, U.S. soybean, cotton, and corn farmers have rapidly
adopted them. As adoption has spread, there have been policy debates over the costs
and benefits of GE products.
Issues include the impacts of GE crops on the environment and food safety, and
whether GE foods should be specially labeled. Underlying these issues is the
question of whether U.S. regulation and oversight of biotechnology — with
responsibilities spread primarily among the U.S. Department of Agriculture (USDA),
the Food and Drug Administration (FDA), and the Environmental Protection Agency
(EPA) — remain appropriate, particularly as newer applications (e.g., biopharma-
ceuticals — drugs manufactured with the use of GE crops or animals) emerge that
did not exist when the current regulatory regime was established.
Some U.S. agricultural export markets, notably the European Union (EU), have
taken a more restrictive approach to regulating agricultural biotechnology than the
United States, presenting obstacles for U.S. farm exports. Now before the World
Trade Organization (WTO) is a U.S. complaint regarding the EU’s de facto
moratorium on approvals of new GE crops from 1998 to 2004. Even though the EU
says it has ended its moratorium (with its May 2004 approval of a GE variety of corn
for import), U.S. agricultural interests are concerned that stricter EU rules for
labeling and tracing GE products could continue to discriminate against U.S. exports.
(Under U.S. rules, GE crops do not have to be distinguished from non-GE crops.)
Also, there is debate over whether agricultural biotechnology will improve
(according to proponents) or undermine (according to opponents) food security in
developing countries.
Congress generally has been supportive of GE agricultural products, although
some Members have expressed wariness about their adoption and regulation. The
109th Congress will likely continue to follow trade developments, particularly the
U.S.-EU dispute, as well as U.S. regulatory mechanisms for approving biotech foods.
This CRS report, which will not be updated unless significant policy changes
occur, replaces CRS Issue Brief IB10131, Agricultural Biotechnology: Overview and
Selected Issues. For additional information about agriculture and biotechnology,
contact Tadlock Cowan, Analyst in Agricultural Policy, at (202) 707-7600.

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Contents
Adoption of Biotechnology in Agriculture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Current Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
U.S. Food Products Containing GE Crops . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Future GE Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
“Input” Traits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
“Output” Traits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Regulation and Oversight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Coordinated Framework for Regulation of Biotechnology . . . . . . . . . . . . . . 5
USDA’s Animal and Plant Health Inspection Service (APHIS) . . . . . . 5
Food and Drug Administration (FDA) . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Environmental Protection Agency (EPA) . . . . . . . . . . . . . . . . . . . . . . . 6
Assessments of Current Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Global Trade Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Biotech Wheat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
U.S.-EU Dispute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
The Biosafety Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
GMOs in the Developing World . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Other Selected Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Food Safety and Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Environmental Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Plant-Based Pharmaceuticals from Biotechnology . . . . . . . . . . . . . . . . . . . 15
In Congress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
List of Tables
Table 1. U.S. Acreage in Major GE Crops, 1996 and 2004 . . . . . . . . . . . . . . . . . . 2
Table 2. USDA Biotechnology Related Programs . . . . . . . . . . . . . . . . . . . . . . . 17
Portions of this report were contributed by Barbara A. Johnson, formerly Analyst
in Agricultural Policy, CRS Resources, Science, and Industry Division.

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Agricultural Biotechnology:
Background and Recent Issues
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.
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 (creating traits that benefit crop production, such as pest resistance) to
the “output” side (creating traits that benefit consumers, such as lower-fat oils).
These second generation products could offer 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 limitations 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?
1For inquiries about agriculture and biotechnology, contact Tadlock Cowan at (202) 707-
7600. This CRS report replaces CRS Issue Brief IB10131, Agricultural Biotechnology:
Overview and Selected Issues. Unless noted, sources for this report include various
materials by USDA’s Economic Research Service and Animal and Plant Health Inspection
Service, the Pew Initiative on Food and Biotechnology, various issues of Food Chemical
News, a weekly trade publication, and the Biotechnology Industry Organization (BIO).

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CRS-2
Current Applications
In 2004, GE crops were planted on an estimated 200 million acres worldwide.
The total number of countries growing such crops had reached 17 by 2004, but most
of the acreage was highly concentrated among four crops (soybeans, corn, cotton, and
canola) and five countries. The United States had 59% of global acreage, Argentina
20%, and Canada (6%), Brazil (6%), and China (5%) most of the rest.2
In the United States, over 60 GE versions of 13 different plants were approved
by APHIS for commercial use through late 2004, although most of the crops are not
widely planted.3 Three crops dominate: soybeans, cotton, and corn. Eighty-six
percent of all U.S. soybean, 76% of all upland cotton, and 46% of all corn acres were
planted with GE seed varieties in 2004, according to USDA’s National Agricultural
Statistics Service (NASS; see Table 1). Almost all current commercial applications
benefit the production side of 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 HT soybeans, HT
upland cotton, and to a lesser extent, HT corn. Many of these are referred to as
“Roundup Ready” because they are engineered to resist Monsanto’s glyphosate
herbicide, marketed under the brand name “Roundup.”
Insect-resistant crops effectively have the pesticide inserted into the plants
themselves to control insect pests for the life of the crop. Many of these crops have
been genetically engineered with Bt (Bacillus thuringiensis, a soil bacterium), which
has a naturally occurring pesticide. These insect-resistant varieties are most prevalent
in upland cotton to control tobacco budworm, bollworm, and pink bollworm; and in
corn to control earworm and several types of corn borers.
Table 1. U.S. Acreage in Major GE Crops, 1996 and 2004
(acres in millions)
Soybeans
Upland Cotton (UC)
Corn
% of all
% of all
% of all
Acres
soy acres
Acres
UC acres
Acres
corn acres
1996
4.2m
7%
2.2m
17%
2.9m
4%
2004
64.9m
86%
10.8m
76%
36.3m
46%
Source: USDA-NASS, Prospective Plantings, various issues; ISAAA (see footnote 2).
2 International Service for the Acquisition of Agri-biotech Applications (ISAAA), Global
Status of Commercialized Biotech/GM Crops: 2004. Accessed at [http://www.isaaa.org/]
on January 21, 2005. 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.
3Source: 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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CRS-3
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. Reports suggest that 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
With 13 different GE plants 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, as 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.
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; they 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.
4Sources include Cornell University, Genetically Engineered Organisms Public Issues
Education Project (GEO-PIE), website at [http://www.geo-pie.cornell.edu/crops/eating.
html], accessed on January 21, 2005; USDA’s Animal Plant and Health Inspection Service,
Petitions of Nonregulated Status Granted or Pending by APHIS, at [http://www.aphis.usda.
gov/brs/not_reg.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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CRS-4
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 reviews have found approved GE
crop varieties to be 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 and transfats; 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, bananas, 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. The compounds would 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,”
below). Some varieties of plants under development could also produce
“bioindustrials,” including plastics and polyurethane. 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 for food use are
GE salmon that require as little as half the usual time to grow to market size; other
such fish could follow later.6
5Sources: “Review of Agricultural Biotechnology,” hearing before the Subcommittee on
Conservation, Credit, Rural Development, and Research of the U.S. House Committee on
Agriculture, June 23, 2004 (Serial No. 108-34); BIO; Colorado State University; and ERS,
Economic Issues in Agricultural Biotechnology (AIB-762), February 2001 (table, p. 19), at
[http://www.ers.usda.gov/publications/aib762/].
6So far one GE fish, the “Glofish,” has been marketed in the United States. It is an aquarium
fish that is not approved for consumption. For more on genetically engineered fish, see CRS
Report RS21996, Genetically Engineered Fish and Seafood.

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CRS-5
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 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, or 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

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CRS-6
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.). 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 undergone this process. With one exception,
none of these foods and feeds were considered to contain a food additive, so they did
not require approval prior to marketing. However, a May 1992 FDA policy statement
still in force notes that GE foods must undergo a special review under certain
conditions, such as if the gene transfer produces unexpected genetic effects, changes
nutrients or toxicant levels from the food’s traditional variety, might contain an
allergen from another crop, or would be used to host an industrial or pharmaceutical
substance, for example.7 In November 2004, FDA published draft guidance under
which developers can choose to provide FDA with any information about new
proteins they are using in the early stages of crop development. FDA can then
perform an “early food safety evaluation” to deem whether the proteins would be safe
for human consumption if low levels of it crossed into the food supply. FDA
believes that any potential risk from the low-level presence of such material in the
food supply would be limited to the possibility of it containing or consisting of a new
protein that might be an allergen or toxin.8 FDA accepted comments on the draft
guidance through January 24, 2005.
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
7See 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.
8Allison A. Freeman, “FDA Proposes Safety Approval Program for Field Trials,”
Greenwire, November 24, 2004; FDA, “FDA Proposes Draft Guidance for Industry for New
Plant Varieties Intended for Food Use,” FDA Talk Paper, November 19, 2004, at
[http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01327.html].

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CRS-7
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, prominent U.S. agricultural groups, and many
scientific authorities continue to subscribe to the current coordinated framework
described above. 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 Institute of Medicine/National Research Council 2004 report Safety of
Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects;
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 Environmental
Impacts of Biotechnology-derived and Traditional Soybean, Corn, and Cotton Crops.
These reports generally conclude that current GE crops likely pose no greater
risks than conventional varieties, that each GE product should be assessed on a case-
by-case basis, and that the current U.S. regulatory framework is adequate. However,
the reports have suggested a number of administrative or regulatory changes that
might be adopted to improve oversight.
Critics, including some consumer and environmental groups, 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 new legislation could
clarify agency roles and strengthen their regulatory authority, particularly over future
novel GE applications.
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 outright prohibition of GMOs), and the potential for
inadvertently mixing GE with non-GE crops. One related question is the definition
of “mixing” and whether there should be a threshold de minimis amount of GE
material permissible in non-GE material. A second 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?

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CRS-8
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.9
Utilizing its current legislative authorities, USDA’s 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 (BRS) office; development of a compliance and enforcement unit to ensure
GE developers’ adherence to the rules, and the publication of more stringent permit
conditions for GE-derived plants for pharmaceuticals and industrials (see
“Plant-Based Pharmaceuticals from Biotechnology,” below).
APHIS has been 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 (EIS) evaluating these
regulations, and requesting public comment 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 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 (i.e., strengthen) its
environmental reviews and permit conditions for GE plants producing
pharmaceuticals and industrials. APHIS also solicited comments on ways that it
might ease its requirements for lower-risk products. The agency received over 3,000
comments on its proposal.10 As of this writing, APHIS had not yet issued a draft EIS.
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, 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.11
9The 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/].
10Personal communication, APHIS Legislative and Public Affairs Office, August 2, 2004.
11See also CRS Report RL31970, U.S. Agricultural Biotechnology in Global Markets: An
Introduction. This report 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
(continued...)

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CRS-9
Biotech Wheat
Such trade concerns have been apparent in the debate over whether to introduce
(commercialize) GE herbicide-tolerant wheat. Monsanto had asked the U.S. and
Canadian governments for their approval, and other GE wheat varieties had been
under development. Some producers wanted to plant the wheat as soon as it became
available; others feared 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 wanted developers and
regulators to wait for more market acceptance before releasing GE wheat varieties.
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. officials in wheat-dependent North
Dakota that their country would not import any U.S. wheat products if the Monsanto
application was approved.12
This resistance likely contributed to a decision by Monsanto to discontinue its
efforts to win regulatory approval of a genetically modified wheat variety. Monsanto
announced its decision on May 10, 2004. Although Monsanto withdrew its
applications for regulatory approval from EPA and APHIS, it did not withdraw its
FDA application. FDA subsequently approved the application in July 2004.
However, FDA approval alone is not sufficient to bring the GM wheat to market.
U.S.-EU Dispute
Another trade case is the U.S. complaint against the EU’s former de facto
moratorium 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 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 further 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 in spring
2005.13
11(...continued)
Resource Policies, Briefs 1-6, January 2003; and CRS Report RL31568, Plants, Patents,
and Seed Innovation in the Agricultural Industry.
12Sources include Food Chemical News, various issues; Cornell University GEO-PIE; and
several news wire service reports.
13Ag Biotech Reporter, “WTO Meeting Summary,” Vol. 21, Issue 9, September 30, 2004.

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EU officials have told the United States that the EU’s cautious approach to
regulating agricultural biotechnology is necessary to restore confidence among
European consumers, who have become much more wary of changes in food
production, after a series of major food safety crises 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. In May 2004, the EU
approved a GE variety of canned sweet corn for import. In July 2004, it also
approved the importation of a second GE corn variety for animal feed, and approved
imports of the same variety for use in food in October 2004.
However, the EU deadlocked on whether to allow imports of a different variety
of corn in November 2004, and some of its member countries have passed bans on
certain EU-approved GM products. At least one EU country, Germany, has
addressed the issue of potential liability from GM crops — passing a law in
November 2004 that holds farmers who plant GM crops liable for damages to nearby
non-GM fields (even if the GM farmers adhered to planting instructions and
regulations). 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.
The WTO case does not involve the EU’s new “labeling and traceability”
regulations, in effect as of April 2004, to require most food, feed, and processed
products from GMOs to be labeled (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 the EU regularly
approves GMOs, the 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.14
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.
The protocol, which 114 countries had ratified as of March 1, 2005, 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. According
14See CRS Report RS21556, Agricultural Biotechnology: The U.S.-EU Dispute.

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CRS-11
to the United States, the measures would mandate overly detailed documentation
requirements and 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.15
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 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 Angolans.
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.16 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.
In Asia, particularly China and India, governments view GMOs as a way to
produce more food for burgeoning populations, despite some in-country opposition.
China has been researching GMOs since 1986, and may approve GE rice within the
next two years. If so, it would be the first time a GE plant was used widely as a
staple food, and may influence the decisions of other Asian countries with regard to
accepting GE foods.17
In the debate over the potential contribution of biotechnology to food security
in developing countries, critics argue that the benefits of biotechnology in such
countries have not been established and that the technology poses unacceptable risks.
They also suggest that intellectual property rights (IPR) protection gives
multinational companies control over developing country farmers. Proponents 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
15Sources include CRS Report RL30594, Biosafety Protocol for Genetically Modified
Organisms: Overview; and various USDA and U.S. State Department background materials.
16U.N. Wire, “Bush, EU Spar Over Genetically Modified Foods,” June 24, 2003, at [http://
www.unwire.org/].
17“China Could Be First Nation to Approve Sale of GM Rice,” Science, 306:1458-1459
(November 26, 2004).

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CRS-12
force for sustained agricultural productivity in the 21st century. They maintain that
IPR difficulties have been exaggerated.
The Food and Agriculture Organization (FAO) of the United Nations has given
a qualified endorsement of agricultural biotechnology. FAO said that biotechnology
“can benefit the poor when appropriate innovations are developed and when poor
farmers in poor countries have access to them.... 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, 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.”18
Other Selected Issues
Food Safety and Labeling
In the United States, 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.
In July 2004, the Institute of Medicine and the National Research Council
(IOM/NRC) of the National Academies of Science released a report generally
supporting the proponents’ view. The IOM/NRC found that food safety should be
assessed based on the composition of the altered food (e.g. whether it contains new
compounds, unusually high levels of nutrients, or other significant traits) rather than
how the food was produced (by genetic engineering or conventional methods).
However, the IOM/NRC determined that the safety of modified foods should be
assessed on a case-by-case basis and cautioned that scientists’ current ability to
predict adverse consequences of genetic changes is limited.19
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
18Food and Agriculture Organization, The State of Food and Agriculture 2003-2004, at
[http://www.fao.org/documents/show_cdr.asp?url_file=/docrep/006/y5160e/y5160e00.htm].
19Press release, “Composition of Altered Food Products, Not Method Used to Create Them,
Should Be Basis for Federal Safety Assessment,” The National Academies, July 27, 2004.
At [http://www4.nationalacademies.org/news.nsf/isbn/0309092094?OpenDocument].

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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 labeling. It contends that consumers might
interpret GE labels as “warning labels” implying that the foods are less safe or
nutritious than conventional foods, when the industry believes 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 from being called
“organic”).
In the House Appropriations Committee report on the FY2005 agriculture
appropriations bill (H.R. 4766, H.Rept. 108-584), the committee called on the FDA
to finalize guidance for manufacturers who wish to label their products as containing
(or not containing) ingredients developed through biotechnology. The Senate report
on its version of the FY2005 appropriation (S. 2803) did not comment on this issue.
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 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 have existed for what
amounts, if any, of 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, AP
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-GM 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, 2004, 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. Major grain and
biotechnology industry organizations responded by urging the FDA, EPA and APHIS
to establish a policy governing AP.

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Environmental Concerns
Biotechnology advocates 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 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.20 In May 2004, a separate report by University of Arizona and Texas
A&M University researchers confirmed the spread of GE corn into a nearby field of
20NAS/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.

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CRS-15
non-GE corn.21 In September 2004, a team of researchers from the Environmental
Protection Agency confirmed the spread of GE grass pollen to non-GE grass up to
13 miles away, much further than previous studies would have indicated.22
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.23
Critics are concerned about impacts on the food supply if 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).24
21 “Contamination of refuges by Bacillus thuringiensis toxin genes from transgenic maize,”
Charles F. Chilcutt and Bruce E. Tabashnik, Proceedings of the National Academy of
Sciences, May 18, 2004, 752-7529.
22Proceedings of the National Academy of Sciences, “Evidence for landscape-level, pollen-
mediated gene flow from genetically modified creeping bentgrass with CP4 EPSPS as a
marker,” Watrud et al., at [http://www.pnas.org/cgi/doi/10.1073/pnas.0405154101].
23Also see CRS Report RS21418, Regulation of Plant-Based Pharmaceuticals.
24The 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 nonfood host organisms should be sought, the report concluded.

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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) submitting 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.25
In Congress
Congress generally has been supportive of GE products, although some
Members have expressed wariness about their adoption and concerns about how they
are regulated. The 109th Congress will likely continue to follow trade developments,
particularly the U.S.-EU dispute, as well as U.S. regulatory mechanisms for
approving biotech foods.
In the 108th Congress, 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. Also in the 108th
Congress, Representative Nick Smith introduced bills (H.R. 2447, H.R. 3472, H.R.
4651) to create an interagency task force to promote the benefits of agricultural
biotechnology. Both bills were referred to the House Agriculture Committee, but no
subsequent action was taken on them.
Other members have taken a different approach in proposing bills related to
food and agricultural biotechnology. Representative Kucinich introduced a series of
bills during the 108th Congress (H.R. 2916, H.R. 2917, H.R. 2918, H.R. 2919, H.R.
2920, H.R. 2921) that would have prescribed 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.
Senator Durbin introduced a bill, S. 2546, to require premarket consultation and
approval for GE foods at the FDA. These bills were referred to various committees,
but no further action was taken on them by the 108th Congress.
Congress has provided funding for a variety of biotechnology-related activities
at USDA, primarily through regular annual appropriations measures. The most
25This guidance is available at [http://www.aphis.usda.gov/brs/pdf/011404.pdf].

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recent is the Consolidated Appropriations Act for FY2005 (P.L. 108-447, H.Rept.
108-792). USDA spending for biotechnology related programs totals approximately
$307 million per year (see Table 2). Of the total, approximately $220 million is for
various types of research (mainly through the Department’s Agricultural Research
Service and the Cooperative State Research, Education, and Extension Service).
A hearing on biotechnology was held on June 23, 2004, before a subcommittee
of the House Agriculture Committee. The hearing focused on the use of
biotechnology in agriculture and products currently under research. The committee
also held a hearing on March 26, 2004, regarding trade barriers for agricultural
biotechnology products. Additional hearings are possible in the 109th Congress.
Table 2. USDA Biotechnology Related Programs
(dollars in thousands)
Agency/Primary Activity
2004 Actual
2005 Est.
Agricultural Marketing Service (development of testing
$3,705
$4,048
and certification service)
Agricultural Research Service (biological research and
$178,956
$177,703
infrastructure)
Animal and Plant Health Inspection Service (regulatory
$9,956
$11,708
oversight
Cooperative State Research, Education, and Extension
$102,083
$101,169
Service (biological research)
Economic Research Service (social impact research) $750
$750
Foreign Agricultural Service (international activities
$3,872
$4,008
Forest Service (biological research)
$3,394
$3,169
Grain Inspection, Packers, and Stockyards
$2,602
$2,550
Administration (instrumentation/equipment)
Office of the Chief Economist (risk assessment)
$125
$125
Office of the Secretary (biotechnology and trade
$1,640
$1,627
activities)
TOTAL
$307,083
$306,857
Source: USDA, unpublished table, provided February 15, 2005.

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