Supplementary Memorandum from United States
Department of Agriculture
US REGULATION: PROCESS
11. Would you explain the procedure the USDA
uses to (a) approve field trials and (b) permit commercialization
of a new genetically-modified crop?
What is the legal status of an "deregulated"
or exempted crop? Do you still monitor such crops in any way?
Are these "traceable"? If the exempted crop were to
prove to be a problem, is there any way of withdrawing the exemption?
A. Approve field trials
The Animal and Plant Health Inspection Service
(APHIS) of the USDA, as part of its overall responsibilities to
protect American agriculture against pests and diseases, exercises
oversight for the importation, interstate movement, and the field
testing of most genetically engineered organisms, particularly
most new plant varieties, and assures that these new varieties
are as safe to use in agriculture as traditional varieties (the
term "genetically engineered" means those organisms
derived through the use of recombinant DNA techniques).
The development process for a new test organism
typically involves steps in which the new organism (which we call
a "regulated article") leaves the lab in which it's
developed and is imported or moves interstate or is planted in
the open environment. Those actions require permission from APHIS,
in essence a certification that the action will be performed in
a safe manner. As testing proceeds, an applicant gathers information
typically to establish for him/herself that the product has the
new intended property, and also gathers information to demonstrate
that the organism is safe to grow in the environment. When enough
information is gathered, the applicant petitions APHIS for a Determination
of Nonregulated Status.
USDA procedures provide different options for
the conduct of field trials. Our regulatory approach incorporates
the use of performance standards which focus on results, rather
than design standards. For example, APHIS has two options
under which applicants can seek regulatory approval to conduct
field trials. One is our notification procedure, under which there
are clear eligibility criteria for its use and performance standards
for assurance of safety. The other is our original, traditional
permitting procedure which continues to be required for some field
trails that are not covered under notification, such as those
involving genes encoding products intended for pharmaceutical
The streamlined notification alternative does
not compromise safety. Field tests under either option must be
performed at comparable levels of confinement and care, standards
that we have spelled out clearly. These standards have been demonstrated
to be both sufficient to ensure that field tests are safely conducted
and also achievable in practice. The standards have been met in
each of the field trials involving transgenic plants that have
been conducted in the US and its territories.
Under notification, it is the applicant's responsibility
to certify that he or she will adhere to a set of performance
standards. USDA officials, as well as our State counterparts,
have the option to inspect test sites at any time to verify that
those standards are being met and maintained. We never lose the
option of requiring additional information from an applicant about
the conduct of the trial if we have some concern that in the particular
instance a performance standard may be difficult to meet.
B. Permit (allow) commercialization of new engineered
As a point of clarification, we use the term
"permit" for field testing and "petition"
for the process of deregulation of an engineered plant.
As field testing proceeds, an applicant gathers
information typically to establish for him/herself that the product
has the new intended property, and also gathers information to
demonstrate that the organism is safe to grow in the environment.
When enough information is gathered, the applicant petitions APHIS
for a Determination of Nonregulated Status. APHIS announces receipt
of the petition, solicits public comment, and reviews the submitted
petition information as well as other scientific information our
If we agree, we issue the determination, along
with a Finding of No Significant Impact under the main environmental
statute in the United States, called the National Environmental
Policy Act (NEPA). All Federal regulatory agencies have to comply
with NEPA for any regulatory action that they take. Once such
a Determination of Nonregulated Status is issued, the new variety
or plant line may be treated, from USDA's perspective, like any
other variety of the crop: i.e., it may be grown, tested, or enter
traditional crop breeding programs without any other special oversight
on the part of APHIS. Once any other requirements from other agencies
(such as the FDA or EPA) are satisfied, it can enter into commerce
and be sold or, if it's a commodity like corn, perhaps mixed in
silos with other varieties.
In the US, therefore, new products destined
for commodity streams are grown by farmers, shipped to silos or
grain elevators, and shipped either directly to processors, or
to container ships and then to processors, with each of those
steps again usually based on independent contracts between two
independent entities. These steps are only regulated by the standard
procedures that govern the shipment of the unmodified commodity.
C. What is the legal standing of a deregulated
Once such a Determination of Nonregulated Status
is issued, the new variety may be treated, from USDA's perspective,
like any other variety of the crop: it may be grown, tested, or
enter traditional crop breeding programs without any other special
oversight on our part. A new variety is not used as food or feed
unless the applicant has completed the consultation with FDA.
If the plant is pest resistant or herbicide tolerant, EPA approval
of the plant, or changes to the list of allowed uses for the particular
herbicide, may also be required.
D. Do you monitor such crops?
To date, no post commercialization monitoring
has been found to be necessary and therefore has not been required
E. Are these traceable?
The USDA does not require that applicants provide
us any unique molecular tag that would allow identification of
a specific engineered seed in a mixture of engineered and nonengineered
F. If there is a problem with a crop, is there
a way of withdrawing the exemption?
Yes, USDA has the authority to regulate any
plant that poses a plant pest risk.
12. Why did the US decide to use existing laws
to regulate the products of biotechnology? Why did the US develop
new regulations under these laws?
The United States believes that the use of existing
health and safety laws provided more immediate regulatory protection
and certainty than was possible with new legislation specific
to biotechnology. Moreover, there did not appear to be an alternative,
unitary statutory approach because the broad spectrum of products
obtained through genetic engineering cuts across many different
types of products regulated by different agencies. The United
States believes that the new techniques of genetic engineering
are an extension of biotechnology in general and, thus, new products
developed through these techniques are extensions of existing
13. Could there be any GM plants which would
not require surveillance of any kind from the USDA; for example,
a flower modified by using a gene gun?
In the sense of "surveillance" as
A regulated article is an organism that has
been genetically engineered (using recombinant DNA techniques)
from a donor organism, recipient organism, vector or vector agent
that is a plant pest or contains plant pest components. Other
genetically engineered organisms may be regulated articles if
they have been genetically engineered using unclassified organisms
or if APHIS determines that the genetically engineered organism
is a regulated article.
Thus, somaclonal variants and protoplast fusion
techniques do not meet our definition of "genetically engineered."
Some generically engineered plants do not contain any plant pest
components. For field testing, however, companies do submit voluntarily
for APHIS' approval for field testing of all engineered plants,
irrespective of whether they contain plant pest components. To
date, all commercialized engineered plants have met the definition
of regulated article and have been reviewed by APHIS.
14. Can you explain the different responsibilities
of the USDA, the EPA and the FDA when considering the use of GM
products? Does an applicant apply to each agency, or is there
a central "clearing house" for the producti.e.,
does deregulation by the USDA imply clearance for food, feed or
The Agencies primarily responsible for regulating
biotechnology in the United States are the US Department of Agriculture
(USDA), Environmental Protection Agency (EPA), and the Food and
Drug Administration (FDA). Products are regulated according to
their intended use, with some products being regulated under more
than one agency.
Before commercialization, genetically engineered
plants/organisms must conform with standards set by State and
Federal marketing statutes such as State seed certification laws,
the Federal Food, Drug, and Cosmetic Act (FFDCA), the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic
Substances Control Act (TSCA), and the Federal Plant Pest Act.
There are no national requirements for varietal registration of
Each US agency regulates GM products under separate
statutory authority. Therefore, firms apply separately to the
relevant agency depending on the nature or characteristics of
Here are some examples of common types engineered
plants and which Agency has regulatory responsibility. This information
is available at United States Unified Home page for biotechnology
|New trait/organism||Regulatory review|
|Viral resistance in food crop||USDA
||Safe to grow|
|EPA||Safe for the environment
|FDA||Safe to eat
|Herbicide tolerance in food crop||USDA
||Safe to grow|
|EPA||New use of companion herbicide
|FDA||Safe to eat
|Herbicide tolerance in ornamental crop
||USDA||Safe to grow|
|EPA||New use of companion herbicide
|Modified Oil content in food crop||USDA
||Safe to grow|
|FDA||Safe to eat
|Modified flower color ornamental crop||USDA
||Safe to grow|
A. APHIS responsibilities
Within USDA, the Animal and Plant Health Inspection Service
(APHIS) is responsible for protecting US agriculture from pests
and diseases. Under the authority of the Federal Plant Pest Act,
APHIS regulations provide procedures for obtaining a permit or
for providing notification, prior to "introducing" a
regulated article in the United States. Regulated articles are
considered to be organisms and products altered or produced through
genetic engineering that are plant pests or that there is reason
to believe are plant pests. The act of introducing includes any
movement into (import) or through (interstate) the United States,
or release into the environment outside an area of physical confinement.
The regulations also provide for a petition process for the determination
of nonregulated status. Once a determination of nonregulated status
has been made, the product (and its offspring) no longer requires
APHIS review for movement or release in the United States.
B. EPA responsibilities
In the area of agricultural biotechnology, EPA currently
regulates the following types of products: "plant-pesticides",
EPA's term for substances in plants (and the genetic material
necessary to produce them) that humans intend to use to prevent,
destroy, repel or mitigate a pest; used for example to protect
crop plants in the field or for post-harvest protection; plant-pesticides
in food; microorganisms used as pesticides; microorganisms used
for enhanced nitrogen fixation.
Plant-pesticides: The term "plant-pesticides"
is the designation EPA gives the substances (and the genetic material
necessary to produce them), that plants produce for protection
against pests. In 1994, EPA made the interpretation that these
substances, produced and used in living plants, are pesticides
if humans intend to use them for "preventing, destroying,
repelling or mitigating any pest".
EPA regulates use of pesticides, including plant-pesticides,
under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) through a registration process. No person may distribute
or sell in the United States any pesticide that is not registered
or exempted from the requirement of registration. Before a pesticide
can be registered, it must be shown that when used in accordance
with widespread and commonly recognized practice, it will not
generally cause unreasonable adverse effects to human health or
Since 1994, EPA has registered eight plant-pesticides. To
date, the plant-pesticides registered by EPA have been insecticidal
proteins, of bacterial origin, which are regulated under FIFRA
when they are formulated in products to be sprayed/dusted on plants.
Under FIFRA, EPA performs an assessment of both risks and benefits
associated with use of the pesticide using data submitted to EPA
by registrants, and on other available information from scientific
literature. Under its approach, EPA registers the plant-pesticide
for use in a crop. It does not regulate the plant, per se.
For example, EPA has registered a delta-endotoxin from the bacterium
Bacillus thuringiensis for use in cotton against certain
lepidopteran pests (certain caterpillars and moths).
EPA is also responsible for regulating plant-pesticides in
food under section 408 of the Federal Food, Drug, and Cosmetic
Act (FFDDCA). Before food containing a plant-pesticide can be
marketed, FIFRA and FFDCA require that EPA establish a tolerance
(i.e., a limit on the amount of pesticide residue that may be
in food) or establish an exemption for the plant-pesticide from
the requirement of tolerance. Food includes articles used for
food or drink by humans or other animals. A food containing a
plant-pesticide may not be moved in interstate commerce without
an appropriate tolerance or an exemption from the requirement
of a tolerance.
EPA is currently using regulations originally drafted for
chemical pesticides to regulate plant-pesticides. EPA wishes to
issue regulations specifically tailored to plant-pesticides. In
1994, EPA proposed several regulations to begin this tailoring
for plant-pesticides. EPA intends to issue these regulations in
final form in 1998.
FIFRA gives EPA the authority to issue "Experimental
Use Permits" (EUP) to allow field testing in order to gather
the data necessary for registration. Under current regulations,
potential registrants apply for a permit when the testing occurs
on 10 acres or more of land (or one surface acre of water). EPA
has issued a number of EUPs for field testing of plant-pesticides.
Microorganisms used as pesticides: FIFRA gives EPA
the authority to regulate all pesticides, no matter how they were
made or their mode of action. The first registration of a microorganism
used as a pesticide occurred in the United States in 1948. To
date, hundreds of pesticide formulations, based on some 20 different
microorganisms, have been registered. Regulations appropriate
to the characteristics of microbial pesticides are in place under
both FIFRA and FFDCA section 408.
The FFDCA section 408 requirements apply to microbial pesticides
in food. Regulations for field testing of microbial pesticides
are in place.
Micro organisms used for enhanced nitrogen fixation:
EPA regulates this type of product under the Toxic Substances
Control Act (TSCA) when the micro organism is "new"
within the meaning of TSCA. "New" micro organisms are
those formed by deliberate combinations of genetic material from
organisms classified in different taxonomic genera. TSCA excludes
from its jurisdiction products covered by FFDCA and FIFRA. Thus,
it does not cover pesticides, foods, drugs or cosmetics. In the
area of agricultural technology, the only product EPA has reviewed
to date are micro organisms used for enhanced nitrogen fixation.
EPA has, however, reviewed micro organisms used for other types
of applications, e.g., bioremediation and production of speciality
TSCA gives EPA broad authority to gather information on and
evaluate the risks of chemical substances and mixtures of chemical
substances. It also gives the Agency the authority to regulate
identified risks. EPA has made the interpretation that living
organisms are mixtures of chemical substances and thus subject
EPA's regulations for micro organisms under TSCA address
both field testing and commercial use.
C. FDA responsibilities
The FDA is responsible for food safety and labelling for
all foods, food ingredients, and additives (domestic and imported),
except for meat and poultry products which are regulated by the
USDA. Thus, the FDA's responsibility includes all fruits, vegetables,
cereals, and by-products such as vegetable oils and food starch;
milk; fin fish and shell fish; and flavours, preservatives, sweeteners,
and other additives used in food. The FDA also regulates drugs
used in animals, including food producing animals (e.g., rBST
used to increase milk production) and human drugs and biologicals
produced from plants and animals.
D. Does deregulation by the USDA imply clearance for food,
feed or drug use?
FFDCA does not give EPA the authority to delegate its responsibilities
for plant-pesticides in food or feed to USDA. EPA has not delegated
its responsibility under FIFRA for plant-pesticides or micro organisms
to USDA. In the case of FDA, deregulation by APHIS does not imply
clearance as food, feed, or drug.
16. Does the US only assess products for safety, or would
other issues be considered? Could a permit be refused, or growing
conditions imposed, if an adverse impact on the environment were
thought possible? By whom?
Would the US take into account the presence of alternative
equivalent products already on the market? Does your risk assessment
consider the risk to the non-agricultural environment and could
a permit be refused if an adverse impact on the environment were
thought possible? If this is not the responsibility of USDAAPHIS,
whose responsibility is it?
APHIS' analyses are based on the principle that: the environmental
risk that may be posed by a certain use of a particular organism
will depend on: the properties of the organism, the way the organism
is to be used (including whether the organism is to be used under
containment or in the context of an environmental release), and
safeguards that are built into experimental design or conditions
We have worked closely with member countries of the Organisation
for Economic Co-operation and Development, the OECD, and in other
fora, to bring about international consensus on the safe development,
testing, and use of genetically modified plants and microorganisms.
In performing risk assessments, we have recognised that it
is necessary to identify, and focus in on, specific issues that
are potential components of risk based on the particular organisms
in question or the particular use; for example, plants intended
for use in agriculture, or to be eaten as food, or used to make
ingredients in food. To identify these risk components, it is
necessary to start with a good understanding of the existing traditional
knowledge base and of the procedures that are routinely carried
out in the course of developing any new crop variety that is released
for commercial use. This knowledge serves as a baseline to decide
whether any identified risk is significantly changed in potential
magnitude from any well-known one that is part of established
How are environmental risk assessments performed? Broadly
speaking, we follow Annex 3 of the UNEP Guidelines for Safety
in Biotechnology, which lays out the broad steps in biosafety
review. These can be paraphrased as:
(2) assessing actual risks that may arise from the
(3) determining how identified risks can be managed
and whether to proceed with proposed action;
(4) comparing the assessed risks with those posed by
actions with comparable organisms.
In our risk assessment processes, we focus on the key concept
of familiarity. In 1989 National Research Council, an arm of the
US National Academy of Sciences, published its report entitled,
"Field Testing Genetically Modified Organisms." One
conclusion reached was that the use of plants modified by classical
breeding techniques for field testing has a history of safe use.
That crops modified by engineering should pose risks no different
from those modified by classical genetic methods or similar
traits. Thus, if the genetically modified plant is phenotypically
similar to a plant that has been (or could be) bred by traditional
breeding techniques this parallel association is called familiarity.The
concept of familiarity allows regulators to draw on past experience
with introduction of modified plants into the environment. Familiar
does not necessarily mean safe. It does mean that the level of
risks associated with the introduction of new pest resistance
genes into plants by classical methods and the evaluation of new
cultivars by national variety registration agencies, has made
the introduction into the environment of these types of modified
plants of negligible risk. Other important familiarity factors
are whether the plant is new to the particular environment where
it is intended to grow, the nature of the trait (gene), and that
the evaluations should be made on a case-by-case basis. All engineered
crop plants that have been commercialised in the United States
to date have been grown in the same environment that their nonmodified
progenitors were grown in. The OECD has also recognised the concept
of familiarity as a basis for evaluation of genetically modified
What are the sorts of issues that we concern ourselves with,
with respect to genetically engineered plant species? The types
of safety issues that are raised by these plants are no different
in kind from those with which we are already familiar from traditional
breeding, though the magnitude of any particular risk may differ.
Apart from the case where the introduction of a wholly new species
into a specific environment is under consideration, the environmental
issues with respect to plants center around their potential for
survival, and even more particularly, the potential for enhanced
Specifically, do the introduced traits specifically affect
the ability of the plant to survive stresses, or to disseminate
pollen or other propagules, or to confer increased survival on
those propagules, or to resist particular pests known to play
a major role in limiting the plant's survival outside of cultivation?
Gene movement, however, is not in and of itself a risk. Genes
move freely around via pollen, and interbreeding between compatible
species is a matter of statistics, wind currents, and pollinators.
USDA's focus is on the specific trait, potential recipients of
that trait, and the potential effects.
EPA will refuse to register a pesticide if the Agency determines
use of the product could result in an unreasonable adverse effect.
EPA also has the authority to make a registration conditional
on the use of specified growing conditions. Such conditions would
be imposed if the Agency determined that the conditions were needed
to ensure that no unreasonable adverse effects occurred. EPA statutes
give EPA authority to address all aspects of the environment.
17. Do the US agencies accept products without further scrutiny
that have undergone safety assessment procedures in other countries?
For example, would you accept products from (a) Canada; (b) Mexico;
NIH Guidelines explicitly indicate that products in confinement
would be acceptable if the safety assessments are equivalent to
those supposedly done in US laboratories.
USDA/APHIS has allowed commodities that have undergone safety
assessments in Canada to enter the US for processing (not for
planting). Our approval was based on our experience with similar
types products and our analysis of the Canadian decision document
on these commodities. Since we have had bilateral negotiation
with Canada for more than a decade, and Canada has reviewed many
of the same products that we have, we have a deep understanding
of the similarities in our review processes. Our approval was
contingent on completion of the food safety consultation process
for the commodity at FDA (the plants were not engineered to produce
a substance with pesticide activity).
In addition, APHIS has allowed carnations engineered for
altered flower color to be imported as cut flowers. In their customary
use, these cut flowers are virtually nonviable. Regulated articles
must be viable.
Under FIFRA, no person may distribute or sell in the United
States any pesticide that is not registered or exempted from the
requirement of registration. Thus, pest resistant, genetically
modified seeds being imported into the United States to be planted
would need to comply with the registration requirements under
FIFRA. Commodities, not intended to be planted (i.e., used as
a pesticide) would not have the same requirements under FIFRA
as imported seeds.
Under FFDCA, a food containing pesticide residues may not
be moved in interstate commerce without an appropriate tolerance
or an exemption from the requirement of a tolerance. Under TSCA,
an importer must submit a notice to EPA 90 days before importation
The FDA believes that it is prudent practice for firms, both
domestic and foreign, to consult with the FDA regarding GM products
prior to commercial distribution in the US. Products that comply
with the Federal Food, Drug, and Cosmetic Act may be imported
into the US. The FDA has published guidance for industry and procedures
by which firms may consult with the FDA.
18. Is there any procedure for consulting neighboring countries
prior to approval for commercialisation? For example, would the
US consult Mexico before crops are approved where Mexico is the
center of origin?
Note for questioner: All the maize in the world originates
from Mexico and many Mexican plants and weeds are thus related
to it. Pollen could blow across the border from the US or farmers
could illegally carry plants across the border into Mexico. The
chance of the GM maize crossing with Mexican relatives is thus
much higher than anything that might happen in the US and it follows
that the super weed problem is potentially much greater than,
for example, between the US and Canada. "Genetic pollution"
is also an issue.
For more than a decade, USDA/APHIS has had yearly bilaterals
with Canada and Mexico (individually) on issues related to field
testing and commercialization of engineered plants. Other discussions
have been held trilaterally as members of NAPPO (North American
Plant Protection Organisation). USDA has conducted workshops to
share its experiences in reviewing transgenic plants during field
testing and commercialization phases.
For those countries with which the US shares ocean borders,
USDA has participated in ongoing bilateral discussions on biotechnology
and the environment with Directorate General XI of the European
Commission. As a member of the US/EU Biotechnology Technical Working
Group, USDA has been very active in sponsored workshops on environmental
reviews associated with field testing and commercialisation.
USDA has also been an active member in APEC, participating
in similar workshops on evaluating environmental safety prior
to commercialisation of transgenic plants.
USDA/APHIS provides list of all field tests and plants under
review for deregulation at our home page http://www.aphis.usda.gov/biotech/.
This list is updated daily.
19. Can a crop be given permission for commercialization
in one part of the USA and not in another due to climactic or
other scientific reasons?
What conditions could be applied if this were a federal requirement?
Could any individual State refuse to allow cultivation of a GM
crop even though permission had been given nationally, or could
they impose stricter conditions than those imposed under Federal
To date, all USDA approved engineered plants can be grown
anywhere in the US. The USDA has authority to restrict movement
of plants for scientific-based (e.g., phytosanitary) reasons.
The deregulation of an engineered plant by APHIS is just the first
step in its ultimate commercialization. EPA can geographically
restrict the authorization of pesticides within the United States.
Besides EPA and FDA oversight, some plants may have to be further
tested under the State variety registration laws. All engineered
plants must meet the same State imposed regulation for the specific
plants. For example. all engineered potatoes must meet pathogen
EPA has issued a registration for a plant-pesticide (in corn)
allowing seed containing the plant-pesticide to be sold to farmers
in most of the United States for planting, except for some cotton
growing areas in the southern United States. This geographic limitation
on sales was placed on the registration to reduce selection pressure
on an insect pest that feeds on both corn and cotton. This measure
was taken to attempt to manage the tendency of insect pests to
become resistant to pesticides, in this case resistance to a delta-endotoxin
from the bacterium Bacillus thuringiensis (Bt).
20. If many farmers choose to grow a GM variety to the exclusion
of others, there may be a reduction in agricultural biodiversity.
Are you (or the EPA) concerned about this, and what can be done
to maintain diversity?
In the early 1970s, the US National Academy of Sciences addressed
the question, "How uniform genetically are the crops upon
which the nation depends and how vulnerable are they to epidemics?
Their answer was that "most major crops are impressively
uniform genetically and impressively vulnerable." For example,
53 per cent of the cotton crop is planted to only three varieties
and 71 per cent of the corn to six varieties. APHIS believes that
most of the major crops are just as genetically uniform, if not
more so, than they were 25 years ago. The factors that govern
farmer acceptance of new crop varieties are not in any way unique
to GM varieties. Rather, the introduction of new genes by engineering
could tend to diversify the genetic makeup of major crops in the
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High Oleic Acid Soybeans (Produced by DuPont Agricultural
Products)These soybeans produce an oil containing higher
levels of oleic acid, (82-85 per cent) than found in currently
available soybean oil (24 per cent) and also containing lower
levels of saturated fat. The oil will fit applications that require
stability without the need of chemical hydrogenation.
High pH Tolerant Corn Hybrids (Produced by Garst Seed
Company)These corn hybrids are capable of growing successfully
on the severely alkaline soils that characterise the western United
States corn belt.
Gray Leaf Spot Resistant Corn Hybrids (Produced by Garst
Seed Company)Corn hybrids tolerant to the disease Cercospora
~spp., which attacks corn hybrids in the central and southeastern
G-StacTM Corn Hybrids (Produced by Garst
Seed Company)Corn hybrids featuring "stacked"
genes providing multi-task capability. For example, hybrids that
contain genes for the control of European corn borer (Bt), genes
for resistance to Liberty herbicide and genes for resistance to
imidazolone herbicide all in the same corn hybrid.
Chymogen® (Produced by Genencor International and
Marketed by Chr. Hansen's)Chymogen is the biotechnology-produced
version of an enzyme (chymosin) found in calves that makes milk
curdle to produce cheese. Because it is produced through biotechnology,
it is purer, more plentiful and eliminates variability in the
quality and availability of calves' stomachs. It is used in approximately
60 per cent of all hard cheese products made today.
Bollgard® Insect-Protected Cotton (Produced by Monsanto)Introduced
in 1996, cotton with Monsanto's Bollgard gene is protected against
cotton bollworms, pink bollworms and tobacco budworms.
New Leaf® Insect-Protected Potato (Produced by Monsanto)Introduced
in 1995, the NewLeaf potato is the first commercial crop to be
protected against insect pest through biotechnology. Thanks to
a gene from a variety of the Bt bacteria, the NewLeaf Potato is
resistant to the Colorado potato beetle.
Posilac® Bovine Somatotropin (Produced by Monsanto),
Recombinant Bovine Somatotropin, (rBST)rBST is a naturally
occurring protein hormone in cows that induces them to produce
milk. rBST improves milk production as much as 10 to 15 per cent
and is now used by farmers whose herds represent over 30 per cent
of the nation's cows. It was approved by the FDA in 1993.
Roundup® Ready Cotton (Produced by Monsanto)Approved
in 1996, Roundup Ready cotton tolerates both topical and post-directed
applications of Roundup herbicide.
Roundup Ready® Soybeans (Produced by Monsanto)Introduced
in 1996, Roundup Ready soybeans allow growers to apply Roundup
herbicide over the top during growing season. The result is dependable,
superior weed control with no effect on crop performance or yield.
YieldGard® Insect-Protected Corn (Produced by Monsanto)The
YieldGard gene provides control of the European corn borer throughout
the corn planting season.
NatureGard® Hybrid Seed Corn (Produced by Mycogen)These
corn plants express a protein toxic to European corn borer that
will allow for less use of insecticides.
Chy Max® (fermentation-derived) (Produced by Pfizer,
Marketed by Chr Hansen's)Chy Max® is another version
of chymosin, an enzyme that causes milk to coagulate. It is an
advanced fermentation ingredient that is of higher purity, quality
and activity than natural rennet.
VitroGraft® Grapevine Plants (Produced by Vinifera,
Inc, a wholly owned subsidiary of Epitope, Inc)VitroGraft®
grafted grapevine plants represent the highest-quality planting
material available to the US grapevine industry. Rootstock and
scion materials are in-house disease tested and grafted using
proprietary green-grafting techniques.
Increased Pectin Tomatoes (Produced by Zeneca Plant Sciences)Tomatoes
that have been genetically modified to remain firm longer and
retain pectin during processing into tomato paste.
Source: BIO Member Survey
AGRICULTURAL BIOTECHNOLOGY PRODUCTS EXPECTED ON THE MARKET
WITHIN SIX YEARS
Genetically Engineered Cotton Fiber (Produced by Agracetus,
Inc.)This biotech product will have enhanced fiber
performance, reduce dye-shop pollution and improve textile manufacturing
Liberty LinkTM Soybean, Cotton Canola,
Sugar Beet and Rice (Produced by AgrEvo®)These Liberty
Link TM crops will be available in Canada and/or the
United States. Like Liberty LinkTM corn, when used
together with LibertyTM herbicide, they will allow
farmers greater flexibility and environmental soundness in weed
Seed Link Corn (Produced by AgrEvo®)These
plants provide a more reliable pollination control system for
corn seed production. The use of the Seed Link System eliminates
the need for hand or mechanical detasseling.
Insect-Protected Corn (Produced by AgrEvo®/Plant Genetics
System)These plants express a protein toxic to various
Lepidopteran pests,which allow less insecticide usage. Unlike
insect-protected crops on the market today, the toxin in these
plants binds to a different site in the insect's mid-gut, providing
an advantage to insect-resistance management programs.
IMITM Wheat Seed (Produced by American
Cyanamid)American Cyanamid is co-operating with universities,
public and private laboratories and seed companies to develop
wheat varieties tolerant to imidazoline herbicides. Imidazolinone
herbicides are flexible, environmentally friendly and provide
contact and residual control of weeds common to wheat production,
including ones not controlled by currently registered wheat herbicides.
IMITM Rice Seed (Produced by American Cyanamid)American
Cyanamid is co-operating with universities, public and private
seed companies to develop rice varieties tolerant to imidazolinone
herbicides. Imidazolinone herbicides are flexible, environmentally
friendly and provide superior contract and residual control of
IMITM Sugar Beet Seed (Produced by American
Cyanamid)American Cyanamid is co-operating with universities
and seed companies to develop sugar beet varieties tolerant to
imidazolinone herbicides. Imidazolinone herbicides are flexible,
environmentally friendly and provide superior contact and residual
control of weeds.
BXN plus Bt Cotton (Produced by Calgene, Inc)These
cotton plants will require less chemical herbicide and insecticide
to lower grower input costs and to achieve greater crop yield.
Initial varieties are in field trials. Market introduction is
planned for 1998.
Insect-Protected Tomatoes (Produced by Calgene, Inc)These
tomato plants will require less chemical insecticides to achieve
High-Stearate Oil (Produced by Calgene, Inc)High-stearate
oil is an ingredient in margarine, shortenings and other food
ingredients that would not require hydrogenation, thus reducing
High-Myristate Oil (Produced by Calgene, Inc)This
will be a less-expensive and more-abundant source of raw materials
for soaps and detergents.
Medium Chain Fatty Acids/Medium Chain Triglycerides (Produced
by Calgene, Inc)This will be a less-expensive source
of raw materials for high-performance lubricants, nutritional
formulas and high-energy foods.
High Sweetness Tomato (Produced by Calgene, Inc)Tomato
plants that produce high-flavor tomatoes.
Disease-Resistant Strawberry (Produced by Calgene, Inc)Strawberry
plants that give improved crop yields and longer shelf life.
High Sweetness Strawberry (Produced by Calgene, Inc)High
quality fresh strawberries with improved flavor.
Genetically Engineered Fruits and Vegetables with Longer
Post-Harvest Shelf Life (Produced by Agritope, Inc, a wholly owned
subsidiary of Epitope, Inc.)Using ethylene-control
technology, Agritope, Inc, has created delayed-ripening, longer-lasting
tomatoes, raspberries and strawberries.
AquaAdvantage® Salmon, Tilapia, Trout, Flounder (Produced
by A/F Protein)The AquaAdvantage® salmon, tilapia,
trout and flounder have the capability of growing from egg to
market size (eight to 10 lb) in one to one and a half years. Conventional
fish breeding techniques require three years to bring a fish to
market. This new salmon could make fish more plentiful, decrease
overfishing of wild salmon and lower consumer costs. A/F Protein
expects to introduce the AquaAdvantage® salmon within four
to six years to a public for whom salmon is an increasingly popular
Ripening-Controlled Cherry Tomatoes (Produced by DNAP
Holding Corporation)Using the same technology as in
its Endless SummerTM fresh market tomato, the company
has developed cherry tomatoes with longer market life, improved
flavor and better harvest traits through ripening control.
Seedless Mini-Melon (Produced by DNAP Holding Corporation)This
mini-melon is specially bred for its convenient single-serve size
Sweeter Peas (Produced by DNAP Holding Corporation)Sugar
snap peas have been modified for sweeter flavor and higher yield
by controlling the conversion of sugar to starch using Transwitch®
technology. Pea plants are currently in field evaluations.
Firmer Peppers (Produced by DNAP Holding Corporation)This
sweet pepper has been modified using Transwitch® technology
to remain firmer after harvest. Pepper plants are currently in
Sweeter Peppers (Produced by DNAP Holding Corporation)This
pepper has been modified to be sweeter and tastier by overexpressing
a gene for sweetness. Pepper plants are in early stages of seed
increase and field evaluation.
Ripening-Controlled Bananas and Pineapples (Produced by
DNAP Holding Corporation)Using the same ripening control
technology as in its Endless SummerTM tomato, the company
is developing banana and pineapple varieties with extended market
Strawberry (Produced by DNAP Holding Corporation)The
company is improving the market life of fresh strawberries by
using Transwitch® technology to keep fruit firmer after harvest
and adding genes to resist disease.
High-Solids Potato (Produced by Monsanto)Monsanto
has developed a higher-solids (or starch content) potato by introducing
a starch-producing gene from a soil bacteria into a potato plant.
With the reduction in the percentage of water in the genetically
improved potato, less oil is absorbed during processing, resulting
in a reduction of cooking time and costs, better-tasting french
fries and an economic benefit to the processor.
Roundup Ready® Canola (Produced by Monsanto)Roundup
Ready canola allows growers to apply Roundup® herbicide over
the top of the crop during the growing season, for superior weed
control with enhanced crop safety.
Roundup Ready® Sugar Beets (Produced by Monsanto)Roundup
Ready sugar beets are tolerant of Roundup Ready® herbicide
and provide growers with a new weed-control option while the crop
Roundup Ready® Corn (Produced by Monsanto)Roundup
Ready corn allows over-the-top applications of Roundup® herbicide
during the growing season for superior weed control.
New-Leaf® Y Insect- and Virus-Protected Potatoes (Produced
by Monsanto)These potatoes protect themselves against
the Colorado potato beetle and the potato virus Y.
Second-Generation Bollagard® Insect-Protected Cotton
(Produced by Monsanto)This cotton controls insect pests,
like the original Bollagard cotton, but uses a different mode
of action to help growers manage insect-resistance concerns.
High-Stearate Soy Oil (Produced by Monsanto)This
is a functional oil with healthier properties for margarines and
shortenings. High-stearate oil requires no hydrogenation and contains
no trans-fatty acids, which increase cholesterol.
Bt Sunflower, Soyabeans, Canola and Wheat (Produced by
Mycogen Corp.)These crops will express a protein toxin
providing protection against various caterpillar and beetle pests.
Fresh Market Tomato (Produced by Zeneca Plant Sciences)Zeneca
is modifying the tomatoes for enhanced flavor, color and increased
antioxidant vitamin content.
Banana (Produced by Zeneca Plant Sciences)Zeneca
is developing an inherent resistance to Black Sigatoka and modifying
ripening characteristics in bananas. This will reduce the need
for chemical fungicides as well as improve the agronomics of production
and the quality to the consumer.
Modified Lignin in Paper Pulp Trees (Produced by Zeneca
Plant Sciences under separate agreements with Shell Forestry and
Nippon Paper)By making lignin easier to remove from
cellulosethe primary ingredient in paperpaper makers
can make high quality paper with less energy and bleaching, which
results in benefits to both the paper processor and the environment.
Source: BIO Member Survey
BIOPESTICIDES, HERBICIDE RESISTANCE AND NATURAL PROTECTIONS
are in use today. Biopesticide products are based on natural
agents such as microorganisms and fatty acid compounds. They are
toxic only to targeted pests (such as the European corn
borer) and do not harm humans, animals, fish, birds and beneficial
insects. In addition, because biopesticides act in unique ways,
they can control pest populations that have developed tolerance
to chemical pesticides.
One of the most common microorganisms used in biologically
based pesticides is the Bacillus thuringiensis, or Bt bacterium.
Several of the proteins produced by the Bt bacteria, principally
in the coating the bacteria forms around itself, are lethal to
individual species of insects. By using Bt bacteria in pesticide
formulations, target insects can be eliminated without relying
on chemically based pesticides.
It is also possible to use pheromones in pest control. Pheromones
are naturally occurring substances that insects produce to attract
mates. In pest control, pheromones are used to attract insects
away from crop plants. In recent years, for example, pheromone-based
traps were used to control fruit fly infestations in California.
European corn borers, one of the most prevalent pests, costs the
nation $1.2 billion in crop damage each year.
Planting conditions good for crop plants will also sustain
unwanted weeds that can reduce crop yield. To prevent this, herbicides
are sprayed on crops. Often, herbicides must be applied several
times during the growing cycle, at great expense to the farmer
and possible harm to the environment.
Using biotechnology, it is possible to make crop plants
tolerant of specific herbicides. When the herbicide is sprayed,
it will kill the weeds but have no effect on the crop plants.
This lets farmers reduce the number of times herbicides have
to be applied and reduces the cost of producing crops and damage
to the environment.
We can, today, transplant the genetic information that makes
a given bacteriumsuch as the Bt bacteriumlethal
only to a specific insect (but not to humans or animals) into
plants on which that insect feeds. The plant that once was
a food source for the insect now kills. This process, which
has no effect whatsoever on humans or other species, means that
it becomes less necessary to spray crops with chemical pesticides
to control infestations.
BIOPESTICIDE PRODUCTS CURRENTLY ON THE MARKET
LaginexTM Bioinsecticide (Produced by
AgraQuest, Inc)This product is effective for controlling
a wide range of mosquito larvae in rice, wetlands and other bodies
Disease Free KleentekTM (Produced by
Crop Genetics International)This product increases
yield of sugar per acre.
Spod-XTM (Produced by Crop Genetics
International)Spod-XTM uses a naturally
occurring insect virus to control the beet armyworm. The beet
armyworm is becoming resistant to many chemical insecticides.
Spod-XTM is safer to use and better for the environment.
AspireTM (Produced by Ecogen)AspireTM
is a biofungicide used to protect fresh produce from post-harvest
rot. It is used on citrus, pome fruits, berries and grapes. The
active ingredient is a naturally occurring yeast that is harmless
to all nontargeted organisms.
Condor® Bioinsecticide (Produced by Ecogen)This
product is effective against the tobacco budworm, cotton bollworm,
the soybean looper, velvetbean caterpillar, green clover worm,
gypsy moth and spruce budworm.
Cutlass® Bioinsecticide (Produced by Ecogen)This
is a broad-spectrum bioinsecticide effective against the beet
armyworm, cabbage looper, diamondback moth, cabbage webworm and
Otinem® Insecticide, Bee-scent® and
No-Mate® (Produced by Ecogen).
AQ-10® (Produced by Ecogen)AQ-10®
is a biofungicide that protects crops from powdery mildew. It
is used on strawberries, grapes, tomatoes, cucurbits and ornamentals.
It reduces the use of conventional fungicides.
Mattch® (Produced by Mycogen)Controls
broad spectrum of caterpillars in vegetables, field crops, nuts,
grapes, turf, stored grain, and ornamental and nursery crops.
MVP® (Produced by Mycogen)This product
is used on tree fruits and nuts, vines, cotton and vegetables
to control leaf-eating caterpillar pests.
M-PerilTM (Produced by Mycogen)This
product is used on corn to combat the European corn borer.
M-PedeTM (Produced by Mycogen)M-PedeTM
is used on fruits, vegetables, grapes and ornamentals to resist
soft-body insects and powdery mildew.
DeMosstm (Produced by Mycogen)This product
is used on roofs, buildings, sidewalks and greenhouses to resist
moss, algae and lichens.
Thinex® (Produced by Mycogen)This
product is used for blossom thinning in apples, pears and fruits.
M/C®(Produced by Mycogen)MC is used
on vegetables to control various caterpillar pests.
Source: BIO Member Survey
BIOPESTICIDE PRODUCTS EXPECTED ON THE MARKET WITHIN THREE
QST 153 Biofungicide (AgraQuest, Inc.)For diseases
of grapes, vegetables and fruit (downy mildews, bunch rot, gray
mold and brown rot).
QST 177 Biofungicide (AgraQuest, Inc.)For diseases
of grapes, other fruits and vegetables, turf and ornamental (powdery
mildew, gray mold, scab and damping off).
QST 776 Insect Repellent (AgraQuest, Inc.)Natural
product for repelling mosquitoes, ticks, and other biting insects.
EcologixTM Cockroach Bait (Produced
by Dominion Biosciences)This is the first commercial
product developed from a unique insect growth regulator technology.
It is highly effective in eliminating insect populations, yet
completely nontoxic to users, pets and the environment.
LeoneTM Biofungicide (Produced by Dominion
Biosciences)This product controls a number of plant
diseases by relying on highly active, antimicrobial redator bacteria.
These naturally derived biochemicals offer a new mode of action
for effective and safe control of disease-causing micro-organisms.
CrymaxTM (Produced by Ecogen)CrymaxTM
is a genetically engineered bioinsecticide that is very effective
against a broad range of pests. It will be used on vegetables,
trees, nuts and vines.
EG7826TM (Produced by Ecogen)This
will be a genetically modified insecticide that will control the
fall armyworm, a major insect pest affecting sweet corn.
ScytheTM Herbicide (Produced by Mycogen)This
is used for horticulture and landscape management to combat a
broad spectrum of weeds.
Source: BIO Member Survey.
BT-BASED AND OTHER BIOLOGICAL CONTROL AGENTS
A number of products are in development that will control
insects as well as conventional insecticides, thereby reducing
the use of these products.
Bt technology is used to develop and specially formulate
a line of biotoxin and fatty acid-based products for field testing
in the poultry and livestock industries.
Mycogen, Ecogen and Ciba Geigy Ag Group are three of the
companies developing these products.
Biculovirus Insecticides (Produced by American Cyanamid)These
products express insect-specific toxins and control Lepidopteran
pests at levels similar to chemical insecticides.
Agree® (Produced by Ciba Geigy Ag GroupCiba
Crop Protection)This is a Bt-based bioinsecticide designed
to control pests that affect tobacco, corn and soybean plants.
Design® (Produced by Ciba Geigy)Design®
is a Bt-based bioinsecticide for cotton and soybeans.
Exhibit® (Produced by Ciba Geigy)Exhibit®
is a parasitic nematode for control of insects on ornamental plants
M-Press (Produced by Mycogen)This product will
be used to control the fall army worm in sweet corn and other
Source: The Biotechnology Industry Organisation
INSECT-, VIRUS- AND HERBICIDE-RESISTANCE PLANTS UNDER
Herbicide-Tolerant Plants (Produced by American Cyanamid)American
Cyanamid is working within universities, public and private laboratories
and seed companies to develop a number of crop plants to tolerate
imidazolinone herbicides. This tolerance lets farmers use flexible,
environmentally friendly herbicides while achieving cost-effective
contact and residual control of weeds.
Crops under development for tolerance to imidazolinone herbicides
Herbicide-Tolerant Plants (produced by Monsanto)Monsanto
has genetically modified a number of crop plants to tolerate its
Roundup® herbicide. This natural tolerance lets farmers reduce
herbicide applications while achieving cost-effective broad-spectrum
weed control using a product well known for its favourable environmental
Crops tolerant to Roundup® Herbicides
Bt Cotton, Alfalfa, Canola and Sunflower (Produced by
Mycogen)Plants that express a protein toxic to various
insect pests, which will allow for less use of insecticides.
HOW AGRICULTURAL BIOTECHNOLOGY IS REGULATED
Since combining specific genes from donor and host plants
does not alter the basic nature of the host plant, the result
of genetic modification is predictable and can be carefully controlled.
As with any new variety of food, the developers test extensively
for safety, quality and other factors.
The Food and Drug Administration (FDA) is responsible
for approving the safety of all foods and new food ingredients.
In addition, all producers are required to ensure the safety and
quality of anything they introduce into the food supply.
The US Department of Agriculture (USDA) and the
Environmental Protection Agency (EPA) impose safety requirements
and/or performance standards on the development of pesticides,
herbicides and genetically modified test crops. Examples of tests
include crops with improved disease resistance and animal vaccines
produced from biotech microorganisms.
The EPA regulates the use of chemicals, including pesticides
in the environment. With this authority, EPA must approve any
field test of biotech products with new properties.
The FDA may require that genetic modifications that significantly
alter the nutritional value of the host food, use genetic material
from outside the traditional food supply or use known allergens
be subject to strict premarket testing and regulatory oversight.
The FDA also requires that any genetically modified food
product that significantly alters the host food's nutritional
value or uses material from a known allergen be clearly labeled.
For example, any product that used a gene from a peanut, which
is a potential allergen, would be subject to testing and labeling
requirements. The FDA also has the authority to order unsafe products
off the market.
Antisense technology involves taking the gene in the tomato that
is responsible for softening, creating a duplicate of that genetic
sequence in reverse and inserting it in the tomato. The new genetic
information effectively turns off the softening process, which
allows the tomato to ripen longer on the plant. Back
Somaclonal variation is a biotechnology process that involves
breaking a plant sample down to its individual cells, putting
the cells in a growth medium and regenerating new plant clones
from the cells. The new plants will have a broad diversity of
characteristics. The new plants with the desired characteristics
are then used to create new plant lines through traditional breeding
A biopesticide is any material of natural origin used in pest
control derived from living organisms, such as bacteria, plant
cells or animal cells. Back