Order Code RL30198
CRS Report for Congress
Received through the CRS Web
Food Biotechnology in the United States:
Science, Regulation, and Issues
Updated January 19, 2001
Donna U. Vogt
Specialist in Social Sciences
Congressional Science Fellow
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress
Food Biotechnology in the United States:
Science, Regulation, and Issues
The use of biotechnology to produce genetically engineered foods can potentially
provide greater yields of nutritionally enhanced foods from less land with reduced use
of pesticides and herbicides. This technology has both critics and supporters.
Concerns presented to Congress include potential detrimental effects to human and
animal health and the environment, and violation of religious customs. Supporters,
including individual companies, trade organizations, scientific professional societies,
and academic groups, promote benefits such as enhanced crop yields, better
nutritional content in food, less pesticide use, and greater agricultural efficiency. They
want Congress to defend the U.S. competitive position in export trade of food
biotechnology products. Calls for “right-to-know” labeling or other federal
regulatory requirements, on the other hand, spark concerns about possibly impeding
innovation and adding costs.
In the United States, the regulation of biotechnology food products does not
differ fundamentally from regulation of conventional food products. Three federal
agencies are primarily responsible for the regulation of genetically engineered foods
— the Food and Drug Administration (FDA), the Environmental Protection Agency
(EPA), and the U.S. Department of Agriculture (USDA). Each federal agency is
assigned certain regulatory responsibilities. FDA provides voluntary pre-market
consultations with food companies, seed companies, and plant developers (which they
propose to make mandatory) to ensure that biotechnology derived foods meet
regulatory standards for safety. USDA’s Animal and Plant Health Inspection Service
(APHIS) licenses field testing of crops prior to commercial release of newly
developed plant strains. EPA registers pesticides in U.S. commerce (including plants
engineered to produce pesticides) and establishes levels at which pesticides in foods
are permitted. The White House outlined this multi-agency approach to regulating
the products of biotechnology in a 1986 document entitled Coordinated Framework
for Regulation of Biotechnology.
Some critics are concerned about genes from genetically modified plants
escaping into the environment through cross fertilization. Others fear the potential
overuse of Bt, a natural insecticide, will cause insects to develop resistance to its toxic
effects. They want more testing on the long-term environmental and health impact
of crops that are altered to produce it. Plus they want the government and academic
institutions to conduct independent testing to verify industry data. Industry groups,
however, contend that current regulations more than adequately ensure human health
and safety. The United States is leading the world in privately funded
biotechnological research, genetically modified products, and sales of the technology.
During the last days of the Clinton Administration, FDA published a proposed rule
changing the way the agency currently regulates bioengineered foods, and published
a draft of a guidance document that will advise the biotechnology industry on how to
label its food products. In addition, EPA published final rules on how the agency will
regulate bioengineered crops, called pest-incorporated protectants.
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
The Science of Genetic Engineering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Use of Biotechnology to Produce Food . . . . . . . . . . . . . . . . . . . . . . . . . . .
Genetically Modified Whole Food Products . . . . . . . . . . . . . . . . . . . .
Future Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Federal Responsibilities for Regulating Genetically Modified Foods . . . . . . . . . . 6
Food and Drug Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
U.S. Department of Agriculture (USDA), Animal and Plant Health
Inspection Service (APHIS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
U.S. Department of Agriculture, Food Safety and
Inspection Service (FSIS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Environmental Protection Agency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
EPA’s Final Plant-Incorporated Protectant Regulation . . . . . . . . . . . 16
Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labeling for Public Health and Religious Practices . . . . . . . . . . . . . . . . . .
Public Health Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Religious Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Environmental Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bt Resistance and Intervention Strategies . . . . . . . . . . . . . . . . . . . . .
Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Economic Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
International Trade Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Concluding Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
List of Tables
Table 1. Overview of Agency Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Table 2. EPA Registered Plant-Incorporated Protectant . . . . . . . . . . . . . . . . . 15
Table 3. Exemptions of Viral Coat-Proteins from Requirements of a Tolerance 16
Food Biotechnology in the United States:
Science, Regulation, and Issues
Genetic modification of agricultural crops promises the availability of food
products with more desirable traits, such as higher quantities of vitamins or lowered
amounts of saturated fats for consumers, reduced use of pesticides and other
chemicals for environmentalists, and increased yields for growers. Traditional plant
breeding, the conventional method to modify plants’ genes, has produced similar
benefits. But recent biotechnological innovations allow scientists to select specific
genes from one plant or animal and introduce them into another to confer desirable
traits. This produces the new plant or animal more quickly than conventional
methods, and creates plants and animals with traits not found previously in nature.
Proponents argue that advances in genetics and new technologies can produce foods
with greater yields to feed the growing world population in the 21st century. Critics
are concerned that this technology produces uncertainties about potential long-term
impacts on public health and the environment, and increases problems related to
The federal government under statute and through regulation attempts to ensure
that food manufacturers produce safe products. However, some Members of
Congress have asked whether federal regulations adequately manage genetic
engineering risks to public health and safety, and the environment. Nine bills
introduced into the 106th Congress asked that the Administration pay more attention
to these risks. Similar bills are likely to be introduced into the 107th Congress which
will call for the same additional scrutiny and research.
This report discusses the science of food biotechnology, and the federal structure
by which it is regulated. Because U.S. farmers are adopting this technology at a rapid
rate, some observers advocate a more active role for the federal government to ensure
that farmers have equal access to this technology. Others believe that federal officials
should play a more active role in protecting the environment, funding more research,
and participating in international trade negotiations to ensure that trade continues to
expand for genetically engineered crops. Trading partners often label food products
that have been genetically modified as genetically modified organisms (GMOs). Many
of those partners have labeling requirements for GMOs to allow consumers the “right
to know” their food content.
Several congressional committees oversee federal governance of genetically
engineered foods and biotechnology. In the Senate, food biotechnology issues are
considered by the Committees on Agriculture, Nutrition, and Forestry; Health,
Education, Labor and Pensions; Environment and Public Works; and Governmental
Affairs. In the House, food biotechnology issues are considered by the Committees
on Agriculture; Energy and Commerce; Government Reform; and Science. The
Appropriations Committees of both the House and Senate have oversight
responsibility on how the major federal agencies set and enforce policies affecting the
safety of genetically engineered foods.
The Science of Genetic Engineering
Biotechnology is defined as the use of biological processes for the development
of products such as foods, enzymes, drugs, and vaccines. Biotechnology is the new
label for a process that humans have used for thousands of years to ferment foods
such as beer, wine, bread, and cheese. In these cases, biological processes are used
to alter raw food products to produce more stable foods. Presently, the term
biotechnology is used to describe genetically engineered foods that contain genes
modified by modern technologies.
When plants breed in the wild, genetic changes occur spontaneously and result
in a haphazard transfer of a large number of genes within closely related species.
Traditional plant breeding is more selective and creates plants with improved yields
or some other desirable trait among closely related species. Often, unwanted genes
conferring undesired characteristics may be transferred along with the desired
characteristics. Breeding itself takes time due to the need to backcross each plant to
eliminate undesirable traits.
Modern genetic engineering gives greater control of the process and transfers
specific genetic material into the cells of a plant. This method can reduce the
likelihood of unexpected results. Also, plant breeders can use the newer genetic
techniques to move genes among unrelated species to yield plants with novel traits
that could not be produced by traditional breeding.
Several techniques are employed by genetic engineers. All involve DNA transfers
from one plant or animal to another. DNA, deoxyribonucleic acid, is the chemical
from which genes are constructed. Specialized laboratory techniques, generally
referred to as recombinant DNA (rDNA) techniques are used to manipulate DNA
isolated from animal, plant, or microbial cells and to introduce the engineered DNA
sequences into another organism. The laboratory techniques of genetic engineering
may involve direct cellular uptake of DNA, forced introduction of DNA into a cell,
or the use of a non-pathogenic carrier to transmit genetic material into a cell.
Additionally, some microbial cells in immediate contact can transfer DNA directly
from one cell to another. Plants may also be genetically modified by fusion of whole
After plant cells are genetically modified, tissue culture techniques are used to
encourage growth of the modified cells into whole plant systems with leaves, stems,
Grosser, J., and F. Gmitter. “Protoplast Fusion And Citrus Improvement.” Plant Breeding
Reviews, (Ed., J. Janick), v. 8, Chap.10. Timer Press, Portland, OR.,1990.
and roots. New food plant characteristics depend on which genes are transferred,
whether these genes are switched on (expressed), and the interaction between genes
and the cellular environment in which they reside.
Use of Biotechnology to Produce Food
The first wave of agricultural biotechnology food products is not substantially
different from those foods already familiar and available to consumers. These modified
agricultural commodities have, for the most part, directly benefitted agricultural
producers with increased yields and reduced production costs. According to an
industry trade association, genetically engineered food crops planted and marketed
by U.S. farmers include corn, canola, rice, tomatoes, potatoes, and soybeans.
Peppers, sunflowers and peanuts are in the pipeline for approval. Other genetically
engineered food crops, such as sugar beets, wheat, squash, papayas, berries, bananas,
and pineapples, have been developed in laboratories, and will go through the approval
process for marketing within the next few years. Non-food plants that are being
genetically modified include trees, for pulp wood, and cotton, although cotton seed
oil may be used in food products.
Genetically Modified Whole Food Products. Some of the products
referred to above have been genetically modified to be either resistant to pesticides,2
or to make their own pesticides. Those modified to resist pesticides allow farmers to
use a herbicide for weed control without killing the food crop. This use reduces
competition from weeds for nutrients and increases yields. Other products of
bioengineering produce insecticides within their cells. Crops such as corn, cotton, and
potatoes, have been genetically engineered to make their own pesticide.
Farmers rapidly accepted these genetically engineered field crops with increasing
acreage of herbicide resistant crops. The use of these plants reduces the need to
plow, decreases the amount of chemical herbicide needed, produces higher yields, and
can deliver a cleaner and higher grade of grain and product.3 Of the total 1998 crop,
approximately 25% of planted corn was genetically modified, 38% of planted
soybeans, 45% of cotton, and 42% of canola.4 In 1999 the percentage of acres
The term “pesticide” is the general category of substances that are toxic to pests; herbicides,
insecticides, and rodenticides are all pesticides.
James, Clive. “Global Review of Commercialized Transgenic Crops.” International Service
for the Acquisition of Agri-biotech Applications Briefs, no. 8, 1998, ISAAA: Ithaca, NY.
Statistics come from the following sources: Terri Dunahay. Economic Research Service,
January 20, 1999; A.S. Moffat. “Toting Up the Early Harvest of Transgenic Plants.”
Science, v. 282. p. 2176-2178; M. Pollan. “Playing God in the Garden.” New York Times
Magazine, October 25, 1998. p. 44-51, 62-63, 92-93; R. Ortiz. “Critical Role of Plant
Biotechnology for the Genetic Improvement of Food Crops: Perspectives for the New
Millennium.” Electronic Journal of Biotechnology, v. 1, no. 3, December 15, 1998.
[http://www.ejb.com]; J. Bernice. “Medicine Man.” Farm Journal, mid-January 1998. p. 22;
Genetic Engineering News, February 1, 1999: “Cancer Vaccine Made in a Plant-based
System”, p. 1 were collected from: Science (1998), v. 282, p. 2176; Michael Pollan, N.Y.
Times Magazine, October 1998; R. Ortiz, Electronic J. Biotechnology, v. 1, no. 3, December
planted with corn grew to 37% but declined to 25% in 2000. In 1998 in the United
States, herbicide tolerant soybeans became the dominant bioengineered crop, with 4.1
million acres planted (about 36% of the total U.S. acreage planted in soybeans). In
1999, bioengineered soybean plantings increased to 47% and continued to increase
to 54% in 2000. Cotton has followed a similar trend. Herbicide resistant crops of
soybeans, corn, and cotton accounted for most of the acreage planted in biotech
Various companies have targeted different genetic modifications to produce
tomatoes that remain firm for a longer time and are reputedly more flavorful than
traditional tomatoes. Calgene’s Flavr Savr tomato was one of the first genetically
engineered consumer-ready foods to receive federal approval for production and
marketing in the United States (see text box on page 9). Another tomato engineered
by Zeneca, used for production of a reduced-price tomato paste for sale in the United
Kingdom, was withdrawn due to consumer protests.
Biotechnology is also used to produce experimental “transgenic” animals, in
which the genetic material has been deliberately modified and to produce “clones” in
which animals are reproduced artificially but the DNA is not modified. In agriculture,
transgenic animals may be altered to produce higher yields of specific products (meat,
milk, etc.) or to bring about commodities with enhanced characteristics, such as less
cholesterol or reduced fat content. Although cloning has been used to reproduce
animals for scientific purposes since the 1950s, its usefulness for the reproduction of
identical livestock animals was only recently investigated. In 1995, sheep were cloned
from embryonic cells in Scotland. In 1996, a substantial breakthrough followed when
a sheep, Dolly, was cloned from an adult, nonembryonic cell.5 Japanese scientists are
creating high-value beef cattle through cloning. They have successfully cloned at least
19 calves from adult bovine cells. Because the cost of some premium beef roasts can
be between $100 and $200 per pound in Japan, the Japanese cattle industry can
support the expense of cloning prize beef cattle.6 But even with those prices, the cost
of genetically engineering cattle on a large scale could be prohibitive.
At this time, most of the research on transgenic animals in agriculture is
experimental. The Biotechnology Industry Organization (BIO), an industry trade
organization, estimates that the only transgenic animals that will be marketed within
the next 6 years are transgenic fish that can grow to market size more rapidly than
traditional farm-raised fish. Experiments are also being conducted to produce
transgenic animals that yield human pharmaceuticals such as vaccines, growth
hormones, blood-clotting factors, monoclonal antibodies and other drugs.
15, 1998. [http://www.ejb.com]; S.D. Moore. “Agro-chemical Rivalry Heats Up:
AHP-Monsanto Pact Raises Pressure.” The Wall Street Journal Europe, June 5-6, 1998, p.
Wilmut, I., A. E. Schnieke, J. McWhir, A.J. Kind, and K.H.S. Campbell. “Viable Offspring
Derived from Fetal and Adult Mammalian Cells.” Nature, v. 385, February 1997. p.
Normile, Dennis. “Bid for Better Beef Gives Japan a Leg Up on Cattle.” Science, December
11, 1998. p. 1975-1976.
Enhancement of milk from cows, goats and sheep to contain these drugs is the target
of much of this research.7
Animal products also have been changed by biotechnology. A food processing
agent, chymosin (also called rennin) is an enzyme required to manufacture cheese.
It was the first genetically engineered food additive to be used commercially.
Traditionally, processors obtained chymosin from rennet, a preparation derived from
the fourth stomach of milk-fed calves. Scientists engineered a non-pathogenic strain
(K-12) of E. coli bacteria for large-scale laboratory production of the enzyme. This
microbiologically produced recombinant enzyme, identical structurally to the calf
derived enzyme, costs less and is produced in abundant quantities. Today about 60%
of U.S. hard cheese is made with genetically engineered chymosin.8 In 1990, FDA
granted chymosin “generally-recognized-as-safe” (GRAS) status based on data
showing that the enzyme was safe.9 The final enzyme product is purified by removing
potentially harmful substances, including the gene for antibiotic resistance used to
engineer the microorganism that produces chymosin.
Bovine somatotropin (BST), also known as bovine growth hormone (BGH),
occurs naturally in cows. When recombinant bovine somatotropin (rBST), is injected
supplementally into dairy cattle, milk production may increase 10% to 15% (see text
box). Genetically engineered microorganisms produce a consistent and affordable
supply of this hormone as opposed to isolating the compound from limited bovine
sources. According to an industry trade association, it is possible that up to 30% of
U.S. dairy cows are injected with recombinant BST to increase milk yield.10
Future Products. Experts indicate that the “second wave” of genetically
modified food products will target consumer and animal health issues and improve the
nutrition content of certain foods. For example, vitamin A shortages that are a
significant health concern in developing countries could be addressed by increasing
the vitamin A content in canola oil. Genetically engineered soybeans, peanuts, and
sunflowers may contain reduced levels of saturated fats or have altered fatty acid
compositions for enhanced health benefits and to improve vegetable oil stability
without the need for chemical hydrogenation. (Hydrogenation is used to create fats
that are solid at room temperature — margarine, solid Crisco, etc.) Fruits may also
Charles, Craig. “Near-term Benefits of Cloning Likely To Be Medical.” Washington Post,
March 29, 1997.
BIO: Website of the Biotechnology Industry Organization, Washington, D.C.
FDA classifies food additives into four categories: GRAS additives (generally- recognizedas-safe) are exempt from regulation because their extensive use has produced no known
harmful effects; direct additives are intentionally added to foods; prior-sanctioned substances
are substances which were approved by FDA or USDA before the passage of the 1958 food
additives amendment to the FFDCA (Section 409, 21 U.S.C. 348); and indirect additives,
sometimes called food contact substances, are often trace substances that leach from
packaging materials and migrate to food during processing or storage.
BIO: Website of the Biotechnology Industry Organization, Washington, D.C.
be genetically engineered to contain vaccines. These fruits could be delivered without
special care to developing countries which often don’t have refrigeration necessary
for current vaccines.11 Genetically engineered salmon, trout, and flounder achieve
market size in half the time of non-genetically engineered fish. Commercialization of
such fish may help curtail over-fishing of native fish, as well as reduce consumer
prices. In addition, scientists are using genetic engineering to make high-value
products, such as special oils and chemicals. Rapeseed plants have been genetically
modified to produce 35% more of a fatty acid, laurate, for use in soaps, detergents
and other household items. Other plants and animals are being engineered to produce
pharmaceuticals, specialty chemicals, and biologic agents.
Federal Responsibilities for Regulating Genetically
During the 1970s, the development of new techniques for transferring genes
raised concerns about potential hazards. At the Asilomar Conference in February
1975, scientists working with this technology tried to reach a consensus to selfregulate research involving rDNA technology until its safety could be assured. The
National Institutes of Health (NIH) became involved in 1976 when it published
research guidelines using rDNA techniques. Until 1984, the NIH Recombinant DNA
Advisory Committee was the primary federal entity that reviewed and monitored
DNA research. However, a legal challenge forced the Reagan Administration to
consider and propose policies to guide activities of federal agencies responsible for
reviewing biotechnology research and its products.12 In 1984, the White House
Office of Science and Technology Policy (OSTP) published the “Coordinated
Framework for Regulation of Biotechnology,” a framework proposing that genetically
engineered products would continue to be regulated according to their characteristics
and novel features and not by their method of production. It also proposed that new
biotechnology products be regulated under the existing web of federal statutory
authority and regulation.13
In 1986, OSTP finalized this framework. The framework identified lead agencies
to coordinate activities when and if jurisdictions overlapped. For example, the Food
and Drug Administration (FDA) is responsible for regulating food and feeds in the
market that have been modified through genetic engineering. The U.S. Department
of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS),
regulates importation, interstate movement, and environmental release of transgenic
plants that contain plant pest components. It licenses, through permits, the field
Tacket, Carol O. “Vaccines from Edible Plants,” paper presented at the 1998 FDA Science
Forum, Biotechnology: Advances, Applications and Regulatory Challenges. Washington,
December 8, 1998.
Foundation on Economic Trends v. Heckler, 587 F. Supp 753 (D.C. 1984) 756 F.2d 143
U.S. Congress. OTA. New Developments in Biotechnology — Field Testing Engineered
Organisms, Genetic and Ecological Issues, no. 3, OTA-BA-350, May 1988. Washington,
GPO, 1988. p. 60.
testing of food crops prior to commercial release. But agencies’ responsibilities
overlap as some plants have been modified to contain plant-pesticides. The
Environmental Protection Agency (EPA) registers certain pesticides produced in
transgenic plants prior to their distribution and sale and establishes pesticide
tolerances for residues in foods.14 APHIS and EPA together established that APHIS
would regulate the plant itself, particularly those plants engineered to resist herbicides,
and EPA would regulate the pesticide used on the herbicide resistant plant. They also
together established procedures to review and approve field tests of modified plants
and microorganisms. FDA has post-market authority to remove a food from the
market. Table 1 shows an overview of federal agencies’ responsibilities.
Table 1. Overview of Agency Responsibilities
Reviews for Safety
Food, feed, food additives, veterinary
Safe to eat
Plant pests, plants, veterinary biologic
Safe to grow
Microbial/plant pesticides, new uses of
existing pesticides, novel
Safe for the environment.
Safety of a new use of a
Source: This data was compiled from tables found at the APHIS website:
Food and Drug Administration
The Federal Food, Drug, and Cosmetic Act (FFDCA) gives FDA broad authority
to regulate foods by prohibiting the entry into interstate commerce of adulterated or
misbranded foods. It is the legal responsibility of food manufacturers to produce
foods that are not adulterated, unsafe, filthy, or produced under unsanitary conditions.
FDA has authority to inspect foods and food facilities, both domestic and imported,
to ensure that they are manufactured and held under acceptable conditions and are
properly labeled. FDA can seize products or request that they be removed from the
market if they do not meet federal requirements.
The Act also requires that “food additives” not be marketed unless they have
received approval from FDA. But substances added to foods that are considered
generally-recognized-as-safe or GRAS substances do not need agency approval. First
articulated in the OSTP framework document in 1986, FDA determined in 1992 that
bioengineered foods pose the kinds of scientific and regulatory issues that are not
substantively different from those raised by non-bioengineered foods. Thus, FDA
EPA defines “plant-pesticides” as a “pesticidal substance that is intended to be produced and
used in a living plant, or in the product thereof, and the genetic material necessary for the
production of such a pesticidal substance.” The DNA is not itself a pesticide. The plant uses
the DNA to produce a pesticidal substance which is toxic to pests.
regulates foods that have been genetically modified or engineered no differently than
foods created by conventional means.
In a May 1992 policy statement FDA described how its regulatory authority
applies to new plant varieties and derived food products, including those developed
through genetic engineering. The agency decided that companies developing
genetically engineered foods would have to go through a special review in FDA only
! the gene transfer produces unexpected genetic effects;
! the levels of toxicants in the food are significantly higher than present in other
edible varieties of the same species;
! nutrients in the bioengineered food differ from those in traditional varieties;
! the sources of the newly introduced genetic material come from a food plant
associated with allergies;
! the food from the new variety differs significantly in composition from food of
! the food contains marker genes that theoretically may reduce the therapeutic
effects of clinically useful antibiotics;
! the plants are developed to make substances like pharmaceuticals or polymers,
and will also be used for food; or
! the food to be used for animal feed has changes in nutrients or toxicants.
So far, most genetically modified foods have not required pre-market approval,
although a few have had their composition changed significantly such that they were
labeled differently. Most proteins from genes transferred into foods to give them new
traits are either GRAS or otherwise exempt from regulation. A GRAS substance is
excluded from the definition of a food additive.15
FDA has, however, instituted a voluntary consultation process whereby the
developer can resolve any safety or regulatory issues prior to marketing. The agency
has proposed keeping this process voluntary when it published a proposed rule in
January 2001. The proposed rule would require that a food company notify the
agency 120 days prior to marketing a bioengineered food and supply the agency with
safety test data. FDA strongly urges companies to consult the agency prior to the
mandated notification deadline in order to ensure agreement on the types of safety
testing that will be needed. By the end of 2000, developers had consulted with FDA
officials on 44 products: 12 times for corn; 5 for tomatoes; 8 for canola; 5 for cotton
seed; 4 for potatoes; 3 for soybeans; 2 each for sugar beets and squash; and once for
flax, radicchio, and papaya.
Affirmation petitions for “generally-recognized-as-safe” (GRAS) status must be filed to gain
FDA’s formal agreement with a sponsor’s independent determination that a substance is
GRAS. FDA considers that bioengineered substances intentionally added to food are food
additives. FDA must review and approve any food additives that do not have GRAS status
before foods containing new additives can be introduced onto the market.
Case Study of a Commercial Genetically Modified Food: Flavr Savr Tomato
Although a few corporations have made substantial, long-term investments in the application of
biotechnology to foods, not all genetically modified foods are commercially successful. Calgene’s Flavr Savr
tomato, for example, had limited technical success and did not meet commercial expectations. Calgene genetically
modified a strain of tomato to reduce activity of a particular enzyme (polygalacturonase) that affects softening of
outer tissue during ripening. Because the genetically modified tomato had less of this enzyme, it could remain
longer on the vine prior to harvest thereby enhancing its tomato flavor. However, Calgene chose to manipulate
genetically a tomato strain that had qualities more useful for processing than for the fresh market. The Flavr Savr
never achieved commercial success because it cost more and did not taste better than competing cheaper tomatoes.
After its founding in 1980, Calgene conducted basic molecular biology research to investigate optimum
techniques for the genetic manipulation of foods. In the mid 1980s, Campbell Soup co. decided to support
Calgene’s research efforts to produce a genetically modified tomato, presumably for use in Campbell’s products.
In 1989, officials at Calgene initiated discussions with FDA regarding the regulatory status of the tomato. FDA
responded in 1992 by publishing its policy on foods derived from transgenic plants. Essentially, FDA decided to
regulate genetically modified foods as any other food derived from traditional practices. The genetic technology
needed to alter the tomato used an antibiotic marker that produced very small amounts of a non-tomato protein in
Flavr Savr. According to FDA, the protein was viewed as a food additive since it changed the tomato’s
composition. Calgene officially petitioned FDA in January 1993 to allow the presence of this protein as a food
additive. In May 1994, FDA approved Calgene’s petition.
This approval opened the way for commercial marketing of the Flavr Savr tomato. However, in 1993 with
significant public opposition to the genetically engineered tomato Campbell Soup Co. decided not to use
genetically modified tomatoes in its products. Calgene then began efforts to market Flavr Savr as a freshmarket
tomato rather than for use in processing. However, the tomato bruised easily and was less firm than expected.
This characteristic caused production, transportation, and distribution problems. Competition from new tomato
strains bred by traditional methods was an additional obstacle.
As reports of problems with commercialization of Flavr Savr grew, Calgene’s financial condition weakened.
In June 1995, Monsanto acquired a 49.9% equity stake in Calgene through the purchase of Calgene stock. In
August 1996, Monsanto acquired controlling interest in Calgene. Monsanto emphasized other research programs
at Calgene and subsequently moved control of Flavr Savr to another of its subsidiaries, Gargiulo Inc. in Naples,
FL. According to industry sources, Gargiulo discontinued the effort to commercialize Flavr Savr.
In contrast, a British company, Zeneca, succeeded in marketing a genetically modified tomato in England.
Now grown in California and processed into tomato paste for sale in the United Kingdom (U.K.), the Zeneca
tomato has a label declaring that the paste is produced from genetically modified tomatoes. This product has since
been withdrawn from the market because of consumer protests.
Development of this tomato used genetic technology virtually identical to that used by Calgene. Zeneca
chose to genetically modify similar ripening-related enzymes in a tomato strain that had desirable processing
characteristics. The Zeneca tomato yields a paste that is perceived as thicker and more flavorful than other tomato
pastes. When combined with a comparatively low price plus marketing efforts through established market chains
in England, this product has become the best selling tomato paste in the U.K.
Source: J.H. Maryanski. “FDA’s Policy For Foods Developed By Biotechnology.” Genetically Modified Foods:
Safety Issues (Ed.s, Engel, Takeoka and Teranishi). American Chemical Society, Symposium Series 605, Ch. 2,
p. 12-22; “Biotechnology of food.”
FDA Backgrounder . May 1994.
[http://www.fda.gov/opacom/backgrounders/ biotech.html.]; M. Schechtman, Animal and Plant Health Inspection
Service, USDA. “Assurance of Environmental Biosafety for Agricultural Products Derived through Modern
Biotechnology: The Case Study of a Delayed Ripening Tomato. “ The Organization for Economic Co-Operation
and Development Environment Monograph No. 107, Report of the OECD Workshop on The Commercialization
of Agricultural Products Derived Through Modern Biotechnology. [www.oecd.org/ehs/mn107sc.htm.]; M. Groves.
“The Cutting Edge.” Los Angeles Times, August 18, 1997; S. Lehrman. “Biotech Tomato Bruised.” San
Francisco Examiner, January 10, 1993.
On a food product’s label, the FFDCA requires producers of foods to describe
the product by its common name and reveal important facts associated with claims
made or suggested. The agency interprets the FFDCA as not giving it authority to
mandate labeling based solely on a consumer’s “right to know” the method of
production if the final product is considered “safe.” Therefore, the agency does not
mandate labeling to indicate the method by which a new variety was developed (e.g.,
that it was genetically engineered). However, the FFDCA does require that all
information on labels be truthful and not misleading. Special labeling may be required
if the developed food significantly differs from its conventional counterpart such that
the common name would no longer apply. For example, FDA required the renaming
of a soybean oil whose fatty acid composition had been altered by engineering. The
new name, “high oleic acid soybeans,” describes what is different about the oil but not
its production method.
FDA requires special labeling for foods if they pose special safety or usage
issues. For example, if a food had a new protein introduced into it to which people
were allergic, FDA would require the label to reveal that information. In its 1992
policy statement, the agency noted that labeling would be required if genes were
introduced from foods that were commonly allergenic, unless the developer could
scientifically demonstrate that the protein was not responsible for the allergenicity of
the original food. Examples of commonly allergenic food include milk, eggs, wheat,
shellfish, tree nuts, and legumes. In one case, a developer demonstrated that DNA
transferred to soybeans from a Brazil nut caused the production of a protein
responsible for an allergic reaction. Consequently, the private developer discontinued
research on that particular modified soybean. FDA has asked that developers of
genetically modified food demonstrate that the introduced proteins do not share
structural similarity to known allergens and are not resistant to digestive enzymes and
On January 18, 2001, FDA published in the Federal Register a “Draft Guidance
for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been
Developed Using Bioengineering” and is seeking comments. In this document, FDA
reaffirmed that it believes most genetically engineered foods are substantially
equivalent to their conventional counterparts, and it decided it would not require
special labeling of all bioengineered foods because it believes that the use of
bioengineering, or its absence, does not itself cause a material difference in the food.
However, the agency did suggest that because of the strongly divergent views on
labeling, manufacturers may consider providing more information about bioengineered
food. The information given, however, must be shown to be truthful and not
misleading. To avoid false or misleading statements16 about the absence of
bioengineered ingredients (because there are no established threshold levels of
bioengineered constituents or ingredients in foods), or to avoid implying that one food
is superior to others, FDA suggests not using statements such as “GM free” or
“biotech free.” The agency does suggest the word “biotechnology” is preferred by
U.S. Dept. of Health and Human Services. Food and Drug Administration. “Draft
Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been
Developed Using Bioengineering.” Federal Register, v. 66, no. 12, January 18, 2001. p.
some consumers over “genetic engineering” or “genetic modification.” It also claims
that if validated testing is available, it can be used to verify whether the label is
truthful. Or manufacturers could keep records to document the reasons why a food’s
label is truthful. Comments on the draft guidance are requested.
That same day, January 18, 2001, FDA proposed to make mandatory a
notification system whereby a food company would notify the agency 120 days prior
to releasing a genetically engineered food onto the market.17 Along with the
notification must be data that show that the is safe. FDA is not proposing to require
that genetically engineered foods undergo a “food additive” review — the extensive
pre-market approval process. The agency is encouraging industry to consult FDA
about the types of tests that could be needed to prove safety. FDA would then have
time to review the company supplied data and would make it available to the public
for comment. Proprietary information would not however be released to the public.
Critics of this proposed rule think that independent testing of the safety data is
necessary to restore consumer confidence in this food. They assert that the testing
should be done either by the agency or independent contractors but not by the
company that has a vested interest in showing only the product’s safety.
U.S. Department of Agriculture (USDA), Animal and Plant
Health Inspection Service (APHIS)
APHIS issues permits for the importation and domestic interstate shipment of
certain plants, animals, and microbes that have the potential for creating pest problems
in domestic agriculture. The agency has historically regulated pests that attack plants
— any living stage of any insect, mite, nematode, slug, snail, protozoa, and/or other
invertebrate animal, bacteria, fungi, or parasitic plant or reproductive part. It is also
interested in viruses — infectious substances that would directly or indirectly injure
or cause disease or damage plants or plant parts or any processed, manufactured, or
other plant products.18
For new plants that could become pests, APHIS issues site specific permits for
field tests or for release into the environment. The agency reviews permit applications
and prepares an environmental assessment in which it evaluates the probable
environmental impact of the release. The permit application process requires that the
developer disclose information about the development of the plant and that
appropriate facilities and control measures are in place during transport and field tests.
If the agency reaches a “Finding of No Significant Impact” (FONSI), a permit is
issued.19 Before decisions are made, APHIS seeks concurrence with states on
U.S. Dept. of Health and Human Services. Food and Drug Administration. “ Premarket
Notice Concerning Bioengineered Foods”( Proposed Rule). Federal Register, v. 66, no. 12,
January 18, 2001. p. 4706-4738, to amend 21 CFR Parts 192 and 592.
7 CFR 340, et seq.
U.S. Congress. OTA. New Developments in Biotechnology — Field Testing Engineered
Organisms. Genetic and Ecological Issues, no. 3, OTA-BA-350, May 1988. Washington,
GPO, 1988. Chapter 3.
In 1993, APHIS introduced an expedited procedure for approving limited
permits so that field testing of six crops could begin without a completed formal
application that included an environmental assessment. For genetically engineered
plants that meet certain eligibility requirements and performance standards, the
sponsoring company need only submit a “notification” letter to the agency, a modified
and abbreviated application which describes the gene, where the tests will take place,
and the characteristics of the plant. The agency has 30 days to process the application
before the sponsor can proceed with the field test. In 1997, APHIS expanded the
expedited procedure to cover many more crops; by 1998, 99% of all applicants used
the expedited process.
After tests are completed and an application is submitted, APHIS has 120 days
to decide whether the product poses a risk of being a plant pest and whether a
product is ready for full “release” onto the market. APHIS then completes an
environmental assessment before making its decision.
Case Study of a Genetically Modified Hormone: rBST
Bovine somatotropin (BST), also referred to as bovine growth hormone (BGH), is produced within
the pituitary gland of all cows. It helps in the lactation process and is a normal trace constituent of milk.
Farmers inject doses of the genetically modified hormone (called commercially Posilac) into cows to
enhance milk yields and lengthen the lactation cycle. The result is an increase in milk yields of up to 15%.
Prior to the 1980s, BST treatments were experimental and costly, since extractions of bovine tissues were
the only source of the compound. With recombinant DNA technology, the supply of recombinant BST
(rBST or rBGH) is more abundant and less expensive.
Critics are concerned that excessive amounts of rBST could compromise human and animal safety.
They state that FDA did not provide adequate review of data to establish safety of the product prior to its
approval. Six scientists within Health Canada, the Canadian federal agency involved in approving drugs,
contend that the drug may not be safe for human consumption. However, the expert panel charged by
Health Canada to review the drug found no risks to human safety. On January 14, 1999, Health Canada
rejected approval of rBST based on concerns for animal health.
In June 1992, a joint expert committee of FAO/WHO concluded that rBST is safe for use and that
Maximum Residue Limits (MRLs) are unnecessary. After a second review in February 1998, the
committee arrived at the same conclusion. On March 10, 1999, the EU Scientific Committee on Animal
Health and Animal Welfare recommended that the current EU ban on the use of rBST should continue in
In 1989, Monsanto petitioned FDA’s Center for Veterinary Medicine to approve an rBST product
as a new animal drug. The review process took 4 years and was more extensive than most approval
processes due to the controversial nature of the product. In August 1990, FDA published a review of data
on rBST and concluded that it “presents no increased health risk.” An August 1992 GAO report suggested
that there may be an increase in mastitis in cows treated with rBST. The report also suggested there could
possibly be indirect human health effects from residues of antibiotics used to treat cows for mastitis (udder
infections). On March 31, 1993, an advisory committee of FDA’s Center for Veterinary Medicine
concluded that adequate safeguards are in place to prevent unsafe levels of antibiotic residues from
entering the milk supply due to increased mastitis in rBST treated cows.
FDA approved the rBST product, Posilac, on November 5, 1993, with the stipulation that its
developer, Monsanto, conduct a post approval monitoring program (PAMP) to provide further information
related to possible effects on animal health experienced by rBST treated cows. FDA publishes occasional
PAMP updates to summarize clinical manifestations associated with rBST treated cows. Since 1994, there
have been 1,235 reports of adverse reactions in cows treated with Posilac although FDA states “the
reported clinical manifestations are known to occur in dairy cattle not supplemented with Posilac.” It also
indicates that the number and types of reported effects raise no new animal health concerns.
On February 7, 1994, FDA offered interim guidance on labeling of milk from untreated cows, since
some companies wanted to label their milk products as “BST-free.” Products may be labeled as coming
from animals not treated with rBST, but since BST is a normal constituent of milk, FDA determined that
it is misleading to label milk as “BST-free.” In May 1994, FDA’s Food Advisory Committee and
Veterinary Medicine Advisory Committee discussed whether foods derived from cows given supplemental
rBST should be labeled as such. The committee report states “deliberations indicate that any method for
instituting labeling for food from BST-supplemented cows would have to resolve many difficult scientific
and policy questions.” In 1999, FDA requires no labeling of milk products produced from cows
supplemented with rBST.
On December 15, 1998, the non-profit Washington, D.C.-based Center for Food Safety petitioned
FDA to withdraw approval of rBST citing possible health effects not addressed by FDA. As of January
2001 this issue is pending within the agency.
U.S. Department of Agriculture, Food Safety and
Inspection Service (FSIS)
Developers of transgenic animals must submit data to FSIS to prove that the
livestock and poultry involved in biotechnology experiments are not adulterated and
can be slaughtered and sold as food with other beef and poultry. Prior to approving
slaughter and sale, FSIS inspectors look at the number, age, sex, and other factors.
The ultimate disposition of transgenic animal carcasses, whether by rendering,
slaughter for food, or other disposal is of concern to regulators.20
Environmental Protection Agency
The EPA regulates pesticides. Pesticides are broadly defined as any substance
or mixture of substances intended for “preventing, destroying, repelling, or
mitigating” pests. EPA currently refers to “plant-pesticides,” now called “plantincorporated protectants,” as plants that produce pesticides within their tissues.21
Scientists have also genetically engineered plants that are resistant to specific
herbicides. Although herbicide resistant plants are not “plant-incorporated
protectants,” they are subject to EPA regulation since they can affect the use of
EPA regulates plant-incorporated protectants, under the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA) and FFDCA. Under FIFRA, EPA
determines the risk the pesticide substance in the plant poses to humans and the
environment and approves registration of those substances for particular uses that will
not generally cause unreasonable adverse effects. This determination involves
balancing risks from the pesticide with benefits associated with its use.22 A pesticide
(including a plant-incorporated protectant) cannot be sold or distributed in the United
States unless it is registered with EPA.
If the plant producing the plant-incorporated protectant is a food crop, EPA
must establish a “safe level” of pesticide residue allowed, a tolerance level, under the
authority of Section 408 of the FFDCA. A “safe level” of the pesticide residue is
defined as that level at which there is “a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including all anticipated
At the FDA Science Forum on December 9, 1998, Dr. Steve Sundlof of the Food and Drug
Administration stated that appropriate disposition of transgenic animals is becoming a concern
as their numbers increase. He recommended that companies needing to dispose of carcasses
consult with Center for Veterinary Medicine.
EPA has proposed new nomenclature in the Federal Register,”Plant-Pesticides, Proposed
Rule, Supplemental Notice of Availability of Information,”April 23, 1999 (v. 64, no.78) to
amend 40 CFR parts 152, 174 and 180.
International Life Sciences Institute, Health and Environmental Sciences Institute. An
Evaluation of Insect Resistance Management in Bt Field Corn: A Science-Based Framework
for Risk Assessment and Risk Management. Washington, D.C. 1998.
dietary exposures and all other exposures for which there is reliable information.”23
Because no tests of the registered (approved) plant-incorporated protectant have
shown toxicity to humans so far, EPA has given them an exemption from the
requirement for a tolerance level. 24
Table 2. EPA Registered Plant-Incorporated Protectant
Bt Cry 1Ac
Bt Cry 9C
Potato Leaf Roll Virus Potato
Source: Environmental Protection Agency, Biopesticides and Pollution Prevention Division.
EPA has registered few plant-incorporated protectants. Table 2 shows that EPA
has registered three genetically modified crops containing plant-incorporated
protectant: potatoes, cotton, and corn (including field corn, sweet corn, and
popcorn). Table 3 shows that EPA has exempted from the requirement for a
tolerance several genetically engineered viral coat proteins that can be used in food
commodities. So far, all but one EPA-approved products contain a “Bt” deltaendotoxin. The delta-endotoxins are proteins, one of the many toxins that may be
naturally produced by the bacterium, Bacillus thuringiensis, and are species-specific,
affecting only certain insects. They are also virtually harmless to humans and animals.
When a susceptible insect consumes the protein, its digestion is severely disrupted,
further feeding stops, and the pest eventually dies, usually within 2 days.
Section 408 of the FFDCA as amended by the Food Quality Protection Act of 1996.
40 CFR 180.1155. The plant-incorporated protectant registered so far contain Bacillus
thuringiensis, listed in Table 2, and have exemptions from the tolerance requirements.
Table 3. Exemptions of Viral Coat-Proteinsa from Requirements
of a Tolerance
Viral Coat Proteins
Watermelon Mosaic Virus-2 and Zucchini Yellow Mosaic Virus — in or on Asgrow
line ZW20 of Cucurbita pepo L.
Potato Virus Y — in or on all food commodities
Potato Leaf Roll Virus — in or on all food commodities
Zucchini Yellow Mosaic Virus — in or on all food commodities
Watermelon Mosaic Virus-2 — in or on all food commodities
Papaya Ringspot Virus — in or on all food commodities
Cucumber Mosaic Virus — in or on all food commodities
Source: Environmental Protection Agency, Biopesticides and Pollution Prevention Division.
Viral coat proteins are components of the outer cell wall that encloses a virus’ genetic material.
Expression of the coat protein in the plant confers resistance to the virus by a mechanism
known as cross-protection.
In 1994, EPA proposed a rule to refine its regulatory oversight of plantincorporated protectant. As a part of the rule, EPA included in its definition both the
plant-incorporated protectant and the genetic material transferred into the plant.
Under this rule, EPA proposed to exempt several categories of plant-incorporated
protectant from FIFRA and FFDCA section 408 requirements.25 Under this rule, EPA
proposed to exempt: (1) plant-incorporated protectants derived from plants sexually
compatible with the recipient plant; (2) plant-incorporated protectants that act by
primarily affecting the plant;26 and (3) plant-incorporated protectants based on a coat
protein from a plant virus. These rules were designed to exempt certain categories of
substances that EPA believes are low risk based on familiarity and presence in the
food supply, e.g., plant hormones and coat proteins from plant viruses. The agency
believed that these proposed exemptions would result in little or no effects on plants
produced by conventional plant breeding. They could, however, affect research into
innovative plants, according to critics, because of the additional regulatory burden
that the rule would represent. The rule was finalized on January 18, 2001.
EPA’s Final Plant-Incorporated Protectant Regulation. In the January
18, 2001 final rule, EPA clarified three regulations governing plant-incorporated
protectants. With this regulation, EPA intends to ensure that plant-incorporated
protectants derived from genetically engineering will meet federal safety standards
under both the FFDCA and FIFRA. EPA will also set food tolerances for residues of
40 CFR 152.20
An example of a plant-pesticide acting to affect the plant would be the modification of hairs
on tomato plants to inhibit aphids from feeding on the plant.
plant-incorporated protectants (or give exemptions) found in foods. The agency also
exempted from registration plant-incorporated protectants derived from conventional
breeding of sexually compatible plants and genetic material necessary for the
production of plant-incorporated protectants. The final rule did not exempt plantincorporated protectants derived through genetic engineering from sexually
compatible plants; plant-incorporated protectants that act primarily by affecting the
plant; and plant-incorporated protectants based on viral coat proteins. Both these
exemptions were questioned in the National Academy of Sciences report, published
in April 2000, entitled “Genetically Modified Pest-Protected Plants: Science and
Regulation.” EPA has asked for comments on the report’s recommendations.
In September 2000, StarLink corn containing a Cry9C protein, a protein
approved only for use in animal feed, turned up in taco shells. Without approval for
human use, or exemption from approval, the Cry9C protein is considered an
adulterant. The current regulatory system would still not necessarily have caught this
adulterant in human food, even if there had been a mandatory notification and labeling
program. The incident and subsequent problems with StarLink corn being found in
shipments that would have been used in food, however, has led EPA to state
publically that it will probably never again allow the entry of bioengineered products
onto the market that cannot be used in human food. The incident also led FDA to
develop sampling and testing guidance for the industry so that testing results could
be used to verify the labeling of corn with or without the Cry9C protein.
Congress’ attention will likely be drawn to a number of biotechnology issues due
to public concern. Issues include concerns about public health, religious issues,
labeling, the environment, the economic impact of this technology, and international
Labeling for Public Health and Religious Practices
Public Health Concerns. Many consumers express wariness of new
“supercrops” and novelty foods, fearing that introduced genes could prove allergenic
or harmful to human health. For example, if new genes inadvertently caused a plant
to produce toxins at higher levels than are present naturally, there could be long-term
health consequences for humans.27 Some consumers are worried that a gene
In August 1998, Dr. Arpad Pusztai, a scientist from the United Kingdom, told a television
team that a potato that he had genetically engineered to contain a lectin (a naturally occurring
insect resistant protein) had led to harmful health effects in rats. (The 10-day feeding trials
showed rats with weakened kidney, thymus, spleen, stomach wall, and immune system
damage. The rats’ brain size decreased.) His research was disowned by the institute for
which he worked and he was forced to resign. On February 16, 1999, The Guardian reported
that 21 scientists who reviewed the data from the experiments found it credible and protested
this treatment. Michael Sean Gillard, Laurie Flynn, and Andy Rowell. “Food Scandal
Exposed.” The Guardian, February 12, 1999. p.1. Other scientists think that the quality of
introduced into plants to protect against pests could also cause the plant to alter its
pollen, thereby affecting the health of humans prone to some sensitivities.
Some critics are dismayed 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.28 Critics have asked that more tests be
conducted for chronic effects prior to products being placed on the market to ensure
that all uncertainties regarding human health be explored.29 Proponents argue that
additional testing of genetically engineered foods is unnecessary because all foods
must meet the same federal safety standards regardless of whether they are genetically
There is a growing movement among consumer groups that advocate the
labeling of all genetically modified foods (GMO foods) that were produced through
the process of genetic engineering. This position reflects a policy of “consumer
sovereignty” or the “right to know,” which supports the disclosure of all relevant
information on a label so consumers may make food choices based on their own
Religious Practices. Others, particularly religious groups, are concerned
that foods might contain genes from animals, such as swine prohibited by some
religions, and they maintain that they have a right to know if foods contain those
genes.31 Both the kosher (Jewish) and halal (Muslim) communities have mechanisms
in place to determine which products are acceptable to their adherents, and thus have
not concerned themselves with secular labeling issues.32 However, both Orthodox
Rabbis and Muslim leaders have ruled that simple gene additions that lead to one or
the potatoes fed to the rats may not have been consistently monitored and may itself have
caused these problems (“Seeds of Discontent,” The Economist, February 20, 1999, p. 75-77.)
FDA typically uses data generated by individual companies to make regulatory decisions for
food additives, drugs, medical devices, and biologics.
Lehman, H. and J.F. Hurnik, “Concerns about the Ethics of Genetic Modification.” Paper
presented at the Fifth World Congress on Genetics Applied to Livestock Production, August
7-12, 1994. Proceedings, v. 20, as found at:
Thompson, Paul B. “Food Biotechnology’s Challenge to Cultural Integrity and Individual
Consent.” Hastings Center Report, v. 27, no. 4, July-August 1997. p. 34-38.
Flamm, Eric. Office of Policy, Food and Drug Administration, conversation with authors,
January 28 , 1999. Mr. Flamm also said that the arguments about religious freedom issues
are theoretical so far because there are no products on the market that insert genes from
animals into plant species.
Regenstein, Joe, Professor of Food Science, Cornell University, conversation with the
authors, February 12, 1999.
a few new components in a species are acceptable for kosher and halal law.33 The
Muslim community has not yet resolved whether a gene derived from swine is an
exception to the above acceptance. For example, both groups have raised no
objection to the use of bioengineered chymosin (rennin) in the production of cheese.
The status of more significant changes in the genetic makeup of species remains to be
decided. However, cloning, in particular, raises serious ethical/moral issues for
religious leaders of all faiths. That discussion has involved a much broader range of
clergy within the respective communities as well as other communities without dietary
Labeling. Currently, no federal agency requires foods to be labeled as
genetically modified. One reason is because the agency sees these products as
substantiallly equivalent to traditional food products. This assumption has been
supported by the courts. Under Vermont’s 1995 mandatory rBST labeling rule
retailers rather than producers paid the expense of enforcement to ensure that all milk
produced using rBST was so labeled. A federal appeals court overturned this
requirement, and since the spring of 1997, Vermont has authorized voluntary labels
for rBST-free dairy products.34
On January 18, 2001, FDA published a draft guidance for the industry giving
examples of how the food industry could label foods that have or have not been
developed using bioengineering. The guidance suggests that consumers prefer labels
that explain why it was used in the food or how it is different from traditional food.
The guidance suggests that all labels be “value-neutral.” It also suggests that using the
terms “GMO-free” or “not genetically modified” labeling could be misleading because
such a label implies there is a zero level of bioengineered material which is almost
always impossible to verify. The phrase “derived from biotechnology “ would explain
that the claim is being made and would allow consumers a choice about whether to
purchase products produced by the new technology, to make better judgements about
the compliance of the food product with ethical and religious beliefs, and lessen
objections to its use.35 Critics of this draft say that all labeling should be mandatory,
not voluntary. They also claim that if the food companies are not forced to label
genetically engineered foods, if there are health or safety problems, it would be more
difficult to trace illnesses stemming from a particular bioengineered food.
The food industry generally opposes all biotech labeling because consumers may
interpret these to be “warning labels,” implying that the foods produced through
Chaudry, M.M. and J.M. Regenstein. “Implications of Biotechnology and Genetic
Engineering for Kosher and Halal Foods.” Trends in Food Science Technology, v.5, 1994.
Kolodinsky, Jane, Qingbin Wang, and David Conner. “rBST Labeling and Notification:
Lessons from Vermont.” Choices, third quarter 1998. p. 38-40. U.S. Court of Appeals for
the Second Circuit. No. 876, August Term, 1995. (Argued: November 2, 1995 Decided:
August 8, 1996) Docket No. 95-7819.
Some have suggested that the industry use USDA’s organic food labeling regulations,
currently under development, as one way of telling consumers that foods are free of
biotechnology products. Comment by Alan Goldhammer, scientific director of BIO, February
biotechnology are less safe or nutritious than conventional foods. Food production
interests believe that consumers, thinking that a product is different from conventional
foods, may not gain the benefits from foods that have been modified genetically
because they are uneasy with the technology and may not try the products. The
industry supports FDA’s reasoning in the draft guidance.36
Defenders of the agencies’ policies suggest that to date genetically modified
foods are similar to non-GMO foods and are easily regulated under the current policy
structure. If they are substantially different, these foods must be regulated as if they
were food additives and receive FDA approval before being marketed. They state
that current GMOs are not a risk as no scientific evidence shows an effect on human
or animal health. For instance, most plant toxins are acute toxins and are well known,
and tests have been developed to detect them quickly.37 So defenders argue that there
are no proven long-term health consequences for humans. However, few long-term
studies have been completed.
On May 27, 1998, FDA was sued by a group of concerned citizens over the
agency’s “traditional” policy on the sale of genetically modified foods (Alliance for
Bio-Integrity v. Shalala, D.D.C., No. 1:98CV01300, May 27, 1998). The group
claimed that FDA’s refusal to require labeling and safety testing raises health and
environmental concerns and makes it difficult to comply with religious dietary laws.
The suit identified 36 genetically modified foods being consumed daily without the
knowledge of U.S. consumers. The suit cited both the First Amendment’s protection
of religious freedom and the Religious Freedom Restoration Act of 1993, which
requires that federal laws or regulations not impede the free exercise of religion. The
plaintiffs said that FDA’s policy failed to abide by the public notice and comment
procedures of the Administrative Procedures Act, and allowed genetically modified
foods into the marketplace without being identified as such. The suit also claimed
that FDA’s policy is a burden to consumers’ abilities to follow religious dietary laws.
The lawsuit challenged FDA’s policy that genetically modified foods are considered
safe unless they contain substances identified in the 1992 policy which are allergens
or would change the character of the food. The plaintiffs want the agency to carry out
the same testing and safety evaluations conducted for food additive petition approval
because, they argue, changes that might occur as a result of genetic engineering might
include unwanted, unpredictable new toxins and/or carcinogens, elevated levels of
inherent toxins and/or carcinogens, and/or degradation of nutritional quality. In
The agencies have authority under existing laws to regulate these new products in the same
manner as those developed through traditional agricultural and food processing. Food
companies have not been required to disclose their method of development on the label. For
example, sweet corn does not need to be labeled “hybrid sweet corn” because it was developed
through cross-hybridization. Nor did FDA require special labeling for the Flavr Savr tomato,
because the new tomato is not significantly different from conventional tomatoes. If a new
food contains a protein derived from a food that commonly causes allergic reactions, and the
developer cannot demonstrate that the protein is not an allergen, labeling is mandatory to alert
sensitive consumers, because they would not expect to be allergic to the food.
International Food Biotechnology Council, “Biotechnologies and Food: Assuring the Safety
of Foods Produced by Genetic Modification,” Regulatory Toxicology and Pharmacology, v.
12, 1990. p. S1- S196.
particular, they wanted FDA to require the labeling of these foods because the foods
have been changed “materially” and allegedly violate the FFDCA. The suit stated that
“FDA is permitting unpredictable changes to the characteristics of certain foods which
may be difficult for consumers to detect.”38 On August 7, 1998, FDA, through the
Department of Justice, asked the U.S. District Court for the District of Columbia to
dismiss this case because it felt that such charges are not unique to genetic
engineering and the same changes occur in foods that have not been modified. On
September 29, 2000, the Court accepted FDA’s view that genetically engineered
foods did not need special labeling because of consumer demand or because of the
process used to develop these foods. Nor did the court require premarket approval
of the food.39
Proponents of bioengineered crops claim that genetic modification can be less
harsh on the environment than other technologies. They suggest that fewer
agricultural chemicals might be needed to grow pesticide tolerant or insect resistant
crops and that land would need less repeated tilling, which could lead to less erosion
and soil infertility.40 Supporters of genetic modification think that new developments
contribute to environmentally sustainable development and greater food production.
While they believe government regulatory efforts adequately ensure consumer and
environmental health, they are aware of growing consumer concerns and some want
to increase transparency of the regulatory and development process.
Critics have expressed strong concerns about the long-term risks and
consequences of cross-pollination and of the disruption to the “cellular ecology” of
plants. They state that the U.S. policy is based on the assumption of safety but there
is little research on ecological or food safety risks. Scientists have shown that
genetically modified rapeseed (canola) pollen was spread to wild radish weed relatives
in nearby fields. The experiment demonstrated that it was possible to create new
strains of weeds resistant to herbicides.41 If such weeds emerged widely, farmers
would need new, different, or stronger herbicides to counter their spread. Such super
weeds could severely decrease crop productivity. Furthermore, some scientists have
expressed concern that the widespread use of genetically engineered plants could alter
Dern, Adrienne. “Justice Department Asks Court to Dismiss Lawsuit Challenging FDA’s
Policy on Genetically Engineered Foods,” Food Chemical News, August 31, 1998. p. 10-13.
FDA Talk Paper: “U.S. District Court Dismisses Genetically Engineered Food Law Suit
Against FDA.” October 6, 2000.
Doyle, John J. and Gabrielle J. Persley, eds. Enabling the Safe Use of Biotechnology:
Principles and Practice, Environmentally Sustainable Development Studies and Monograph
Series No. 10 (Washington, D.C.: The World Bank, 1996). p. 7. Also several biotechnology
companies modified corn to contain Bt, to kill the corn borer and other pests. The corn borer
causes huge losses. Corn with Bt had a 7% increase in yield per acre, bringing the farmer,
on average, an increased net return per acre of $16.88. Moffat, Anne Simon. “Toting Up the
Early Harvest of Transgenic Plants,” Science, v. 282, December 18, 1998. p. 2176-2178.
Brookes, Martin. “Running Wild,” New Scientist, v. 160, no. 2158, October 31, 1998. p.
the ecology of natural plant communities and of wildlife food chains. Certain seed
and herbicide companies agree with these critics, their point of view shaped by the
possibility of development of “super weeds,” rendering their products useless.42
Bt Resistance and Intervention Strategies. Concerns revolve around
plants engineered to produce within their cells an insecticide called Bt that is produced
naturally by strains of the bacterium Bacillus thuringiensis. The release of a study
that showed in a laboratory that Bt corn pollen when eaten by Monarch butterfly
larvae kill or stunt their growth engendered public concern.43 Another concern is that
large scale planting of crops containing Bt might lead to faster resistance development
by insects. Critics of this technology state that large-scale production of engineered
corn, soybeans and other foods will cause pests to develop resistance to Bt, thereby
limiting its usefulness. It is not unusual for insects to develop resistance to pesticides
that have been used for long periods of time. Organic farmers, in particular, are
concerned because they do not have as many crop protection tools available as
conventional farmers, and the loss of effectiveness of Bt could be a serious blow to
their production. Due to these concerns, on February 18, 1999, Greenpeace, the
Center for Food Safety, and some organic farmers sued EPA over its registrations of
plant-incorporated protectant.44 The suit calls on EPA to cancel all existing
registrations for Bt crops, to cease the approval process for any new registrations, and
to perform an environmental impact assessment analyzing the cumulative impacts
from the current registrations.
Prior to these complaints, EPA determined that resistance to Bt can be slowed
by requiring farmers to plant significant numbers of non-Bt seeds near the genetically
modified resistant plants in designated separate areas called “refuges.” The non-Bt
plants allow pests to grow that will not develop Bt resistance. Since these pests will
interbreed with their counterparts that eat Bt plants, there is less likelihood that a
resistant super-pest could develop. If the “refuge” system is used by farmers, EPA
Critics also worry about altered organisms causing unpredictable and costly environmental
damage over extended eco-ranges for sustained periods, and point to the cases of Dutch Elm
disease, myxomatosis, and gypsy moths to illustrate their point of organisms spreading
uncontrollably . Supporters claim that these invaders were not disease-causing GMOs, but
were unpredicted consequences of unplanned introductions into new environments. Given
multiple ecological problems related to farming practices such as nutrient runoff, for which
there are no liability claims, it seems inappropriate to supporters that GMOs are lumped into
these arguments. Critics suggest, however, that because genetically modified plantincorporated protectant may be unsafe, their release into the environment is irreversible and
unpredicted consequences may be hard to mediate. U.S. Congress, Office of Technology
Assessment, New Developments in Biotechnology — Field Testing Engineered Organisms,
Genetic and Ecological Issues, no. 3, OTA-BA-350 (Washington, DC, May 1988) chapter
Kaesuk Yoon, Carol. “Altered Corn May Imperil Butterfly, Researchers Say,” New York
Times, May 20, 1999. p. A1 and A20.
See website: [http://www.icta.org/legal/bt2.htm]
estimates that the eventual development of resistance to Bt by insect pests could be
extended 10 or more years.45
EPA now requires the use of insect resistance management (IRM) plans for some
crops. EPA originally granted all the plant-incorporated protectants conditional
registrations. With the registrations for corn and cotton to expire in 2001, as a
condition of re-registration, companies will be required to develop effective IRM
plans for these crops. Most re-registration applications have been submitted, and
EPA is evaluating the information and could impose new conditions. Critics of the
technology want mandatory IRM plans, for they claim that if the plans are voluntary,
farmers will either not plant the nonresistant refuges or plant refuges that are too
small to be effective.46
There is a voluntary IRM plan in place for potatoes, as recommended by a 1995
scientific advisory panel, and Monsanto is requiring compliance by growers who
contract with it for the seeds.47 Ongoing evaluation of IRM may result in additional
There is agreement, however, that toxic anti-pest substances produced by plants
used for food must be proven safe. EPA points to an example of potato leaves that
naturally contain a pesticidal substance that could cause birth defects. Since humans
do not eat potato leaves, there is no need to regulate the substance; however, if
spinach were genetically modified to contain the potato-leaf toxin, regulation would
Liability. There is also concern about liability. Who would pay if other crops
or fields were ruined because of cross-pollination with these new seeds? An opponent
Environmental Protection Agency. Scientific Advisory Panel on Bacillus thuringiensis (Bt)
Plant-incorporated protectant. Transmittal of the final report of the FIFRA Scientific
Advisory Panel on Bacillus thuringiensis (Bt) Plant-incorporated protectant and Resistance
Management. Meeting held on February 9-10, 1998. (Docket Number: OPPTS-00231).
As part of the ongoing discussions with EPA and USDA, major see developers (accounting
for more than 90% of the U.S. Bt seed corn market) have proposed that by the year 2000, they
will require growers in contracts to plant 20% to 50% of their acreage in non-genetically
engineered varieties. The agreement among the seed companies calls for a 20% refuge
requirement in primary cotton-growing areas, with the minimum rising to 50% where Bt corn
is grown in proximity to Bt cotton. “Industry Plan for Bt Resistance Management Gets Mixed
Reaction,” Food Regulation Weekly, v, 18, January 1999. p. 3-5.
EPA is considering this proposal among its other options for implementation of IRM
requirements. In the spring of 1999, EPA and USDA are planning a joint workshop to
examine existing Bt crop IRM, including methods, implementation, grower’s incentives,
remedial actions if insect resistance is discovered, and compliance and enforcement issues.
They are also interested in supporting the development and implementation of six to ten
USDA Regional Pest Management Centers.
contains a statement, “We require every grower who decides to plant YieldGard corn to sign
an agreement to establish a refuge adjacent to his or her YieldGard acreage to ensure a
population of susceptible corn borers to mate with any naturally resistant borers that survive
exposure to the Bt.”
of biotechnology, Jeremy Rifkin, says, “The insurance industry has quietly let it be
known that it would not insure the release of genetically engineered organisms into
the environment against the possibility of widespread environmental damage, because
the industry lacks a risk-assessment science — a predictive ecology — with which
to judge the risk of any given introduction.”48 According to Dr. L. Val Giddings, Vice
President for Food and Agriculture, Biotechnology Industry Organization, the
industry representatives directly dispute this claim, and say there is insurance
Critics are concerned about the growing presence of large agricultural
conglomerate companies controlling the supply of seeds containing bioengineered
traits. Growers’ profits from bioengineered crops more than tripled from 1996 to
1997.49 In 1996, U.S. farmers had planted mostly Bt cotton, Bt corn, and herbicide
tolerant soybeans. In 1997, they expanded acreage for those crops and added
herbicide tolerant cotton and potatoes.50 Planted acreage has continue to increase for
all crops except corn. Adoption rates vary by year, crop product, and location. They
depend on the level of infestation of a targeted pest. They also depend on world
commodity prices and the kind of corn that importers are willing to accept.
Supporters of this technology cite convenience and lower costs as the main reasons
for high farmer adoption rates.51 But critics complain about the consolidation of
patent ownership of this new technology which they believe constitutes monopolistic
power in the marketplace. Their distrust is based in part on concern about the
dependency such concentration brings to the agricultural sector and the possible abuse
from such control.
The reasons for this concern vary. The concentration of control of patents in
agricultural biotechnology raises concerns for some farmers and consumers that
multinational corporations want to simplify the regulatory processes of governments
to gain easier approval for their products without adequate review. Because so much
of the technology is held by private companies, some regulators and researchers are
concerned about how difficult it can be to obtain necessary information for
Others are concerned that large companies can conduct field experiments, sell
seeds to farmers, and market genetically engineered products without appropriate
Rifkin, Jeremy. “Genesis II; Commercial Prospects of Genetic Engineering and
Biotechnology,” Across the Board, v. 35, no.6, June, 1998. p. 29.
Beachy, Roger N. Statement Presented to the House Committee on Agriculture,
Subcommittee on Risk Management, Research and Specialty Crops, on behalf of the Council
for Agricultural Science and Technology, March 3, 1999.
James, Clive. “Global Review of Commercialized Transgenic Crops: 1998,” International
Service for the Acquisition of Agri-Biotech Applications Briefs, no. 8, ISAAA: Ithaca, NY;
in 1997, profits totaled $315 million, up from $92 million in 1996.
Riley, Peter A. and Linwood Hoffman. “U.S. Farmers Are Rapidly Adopting Biotech
Crops,” Agriculture Outlook, August 1998. p. 21-24.
attention to tests for the safety of consumers and the environment. Critics want more
testing before farmers expand their planted acreage. There is uncertainty about how
much testing is required, whether it should focus on the new genes themselves or on
the substances they produce in the plant. Federal agencies can ensure adequate safety
testing of biotechnology products by requiring companies to review impacts or by
conducting tests for themselves. The FDA proposed rule, discussed earlier, could
mandate that industry submit this data. However, others feel that independent testing
is necessary to validate the safety of the food product.
There also appears to be concern about how much control companies wield over
research in food and agricultural biotechnology. Companies hold patents and own
specific germplasm52 and research techniques needed for plant research. Some
companies claim partial ownership of a food product created using their patented
technologies. Biotechnology researchers have raised concerns that some private
company scientists are not permitted to share innovations in research.
Most food biotechnology research is financed with private, not public, money,
and the total amount spent is confidential. One newspaper reported that Monsanto
estimates that research and development time and costs to create a commercial
product are about 10 years and about $300 million. For every genetically engineered
seed that goes to field trials, 10,000 have failed along the way.53 Corporations charge
steep prices for this technology, claiming the need to recoup their investment to be
able to research the third and fourth wave of products.
Most identifiable public funding for food biotechnology research for plant
genome research is being sponsored by the U.S. Department of Agriculture (USDA).
The Clinton Administration did not track federal food and agricultural biotechnology
funding of research as a line item in federal budget analyses. Consequently, the total
amount of public funding for this research is unclear.54
Public research funding under the authority of the Bayh-Dole Act of 198555
allows universities receiving grants for plant genomics research to hold the intellectual
property rights for any useful discoveries. The Act has accelerated the linkages
between university research and the creation of consumer products and contributed
to the international competitiveness of U.S. industries. It has also encouraged
research on minor-use crops.
Germplasm refers to the basic genetic material of a species. There are germplasm “banks,”
for a variety of different life forms, where representative species are stored so that they can
be reproduced for future studies that require their genetic material.
Weiss, Rick. “Seeds of Discord,” Washington Post, February 3, 1999. p. A1 and A6.
Gabriel, Cliff, Deputy to the Associate Director of the Science Division, Office of Science
and Technology Policy. The White House, conversations with the authors. February 23,
Bayh-Dole Act, P.L. 96-517, §6(a), December 12, 1980, 94 Stat. 3019 (35 §§200 to 212);
P.L. 98-620, Title V,§501, November 8, 1984, 98 Stat. 3364 (35§§201 to 203, 206 to 208,
210, 212); P.L. 99-502, §9(c), October 20, 1986, 100 Stat. 1796 (35 § 210).
International Trade Issues
At the present time, the United States is leading the world in biotechnological
research, development of genetically modified organisms (GMO’s as they are called
internationally), and sales of the technology worldwide. The United States has no
immediate challengers to this trading position. Some trade experts suggest that
trading partners whose policies strongly reflect consumer concerns about the new
technology are merely attempting to allow their own domestic industry time to
develop a competitive position in this trade. For example, the European Union (EU)
has now required that all GMOs be labeled as such, and has severely limited imports
of food containing genetically engineered crops and foods. The United States,
however, claims that there is not scientific basis to presuppose that genetically
modified food products are more risky or substantially different from other products.
U.S. officials believe that decisions on trade should be science-based and U.S.
regulatory policy reflects this thinking. Such competition for leadership in
biotechnology has influenced trade relationships among U.S. trading partners. Japan
has diminished its import of U.S. corn after finding StarLink in their imports.
Recombinant DNA technology is producing revolutionary changes in agriculture.
Supporters of this technology emphasize the potential benefits from these changes
including the promise of higher yields and nutritionally enhanced foods from
genetically modified commodities with reduced environmental impact. Opponents of
the use of rDNA technology in agriculture are concerned about possible hazards to
human, animal, and environmental health. They advocate more safety testing and
labeling of products. Many are concerned about the possible consolidation and control
of agricultural biotechnology by a handful of multinational corporations.
Since the technology potentially can provide greater yields, farmers are rapidly
planting genetically modified seeds. As the U.S. experience with this new technology
grows, it may become necessary to amend regulatory policies to protect public safety
and the environment while allowing genetically modified crop development to
progress. The agencies involved in regulating genetically modified foods (FDA,
APHIS, and EPA) are implementing policies based upon a 1986 framework document
that coordinates their regulatory activities for biotechnology products. This
framework applies the same set of regulations to all food products and does not
differentiate between foods that are produced with rDNA technologies and those that
are produced by traditional methods. However, with the January 18, 2001 proposed
rule, making mandatory the current voluntary consultation process whereby the
industry now must formally notify the agency 120 days before releasing a food
product onto the market. The proposed rule also lists the safety test data that must
accompany the notification.
Although the United States is leading the world in the production and sales of
genetically engineered products, a few foreign countries have resisted or diminished
their U.S. commodity imports because of concerns over the safety of these
bioengineered crops. Some suggest that foreign countries’ resistance to genetically
engineered crops can be traced to their desire to allow their domestic industry time
to develop a competitive position in this trade and the growing unease in international
trade relationships over the fast adoption by U.S. farmers of bioengineered crops.
Others argue that Congress could exercise more oversight over the regulation of these
food crops, fund more public research, and encourage the Administration to negotiate
the easing of trade barriers and harmonizing standards. Congress will be closely
monitoring these events.