The system for regulating transgenic crops in the U.S.
is complex and evolving. We first describe the current
system, then mention several studies or proposals that
may affect how this system is modified. For additional
information and links, a good starting point is the
web site "United States Regulatory Agencies Unified
Biotechnology Website" (http://usbiotechreg.nbii.gov/).
Transgenic crops are regulated at every stage in their
development, from research planning through field testing,
food and environmental safety evaluations, and international
marketing. These are the major regulators of transgenic
Institutional Biosafety Committee
Most research institutions have an IBC, which monitors
potentially hazardous biological research and ensures
compliance with biological safety procedures. At Colorado
State University, for example, researchers must notify
IBC if planning to work with recombinant DNA in any
form. Depending on the nature of the work, a Biosafety
Level is assigned. For transgenic plants, the appropriate
level would be BL1-P to BL4-P, depending on the potential
risk of a specific transgene. Precautions required for
these four biosafety levels are as follows:
BL1-P - Basic containment level. Restricted
access to greenhouse; insect, weed, and rodent control
mechanisms; screens recommended.
BL2-P - For agents of moderate potential hazard.BL1-P
requirements, plus: Concrete floor; screens restricting
movement of small insects, but not pollen; autoclave
to sterilize transgenic material before removal. CSU's
new plant biotechnology greenhouse is a BL2-P facility.
BL3-P - For agents of serious potential hazard.
BL2-P requirements, plus: Collection and sterilization
of liquid runoff; sealed windows; ventilation filters;
Security fence; protective clothing.
BL4-P - For work with extremely hazardous agents,
including certain exotic plant pathogens. Similar to
BL3-P but even more stringent.
More details and interpretation of the NIH safety guidelines
for transgenic plants and associated organisms is available
An informative guide to growing transgenic organisms
in greenhouses has been written by Traynor
et al. (2001).
Animal and Plant Health Inspection Service (APHIS)
of USDA (http://www.aphis.usda.gov/brs/)
Under the Federal Plant Pest Act, APHIS must determine whether
a transgenic plant variety is likely to become a pest,
i.e., to have negative agricultural or environmental
effects. The agency regulates the import, transportation,
and field testing of transgenic seeds and plants through
notification and permitting procedures, as explained
For most common crops, researchers simply notify
APHIS of their intention to transport or field test
a transgenic plant. Certain criteria must be met
for the introduced gene, including:
stable integration in the plant's chromosomes
non-pathogenic to animals or humans
unlikely to be toxic to other non-target organisms
low risk of creating new plant viruses
For less common crops and for genes or traits posing
a greater risk, researchers must file a formal application
for permission to transport or plant the material.
Field testing, typically conducted in many locations
and several years, requires procedures to minimize spread
of the transgene and keep it out of the food supply.
To commercialize a transgenic plant, the researcher
petitions APHIS for non-regulated status. This requires
extensive data on the introduced gene construct, effects
on plant biology, and effects on the ecosystem, including
spread of the gene to other crops or wild relatives.
After the crop is on the market, APHIS has the authority
to halt its sale if there is evidence that the plant
is becoming a pest. Does APHIS have the authority to
regulate ALL transgenic plants, or only those deemed
to have the potential to become plant pests? An April
2000 report by the National Academy of Sciences (http://books.nap.edu/catalog/9795.html;
see NAS Committee Report)
felt that some transgenic plants might not fall under
APHIS's current regulatory oversight, and recommended
that the agency clarify its scope of coverage.
Food and Drug Administration (FDA) (http://www.fda.gov/oc/biotech/default.htm)
The FDA has
authority under the Federal Food, Drug, and Cosmetics
Act to determine the safety of foods or food ingredients.
FDA staff consult with the plant developer, review safety
and nutritional data, and request additional data considered
appropriate for each product. If the introduced gene
is from a known allergenic source, then the transgenic
food must be assessed for allergenicity. For example,
if a gene from peanut (which causes allergic reactions
in some people) were introduced into soybean, the FDA
would require extensive allergenicity tests. Additional
investigation may be required for transgenic crops if
At the end of the consultation and review process,
FDA sends a letter to the developer stating that the
agency is satisfied with the data regarding food safety
of the product. Information on completed consultations,
including the FDA's letter to the developer and the
FDA's final memorandum, is available at http://www.cfsan.fda.gov/~lrd/biocon.html.
After a product is on the market, FDA has authority
to order its removal if the food is deemed unsafe.
Critics of the FDA's regulation of transgenic foods
believe that the voluntary nature of the consultation
process between FDA and crop developers is inadequate.
Although all companies to date have consulted extensively
with FDA staff and presented large amounts of data on
food safety satisfying FDA's concerns, the lack of a
formal review and approval process prevents that data
from being part of the public record, and may reduce
In late 1999, the FDA held a series of three meetings
to seek public comment on FDA's regulatory policies
and on suitable means to provide information to the
public about transgenic products in the food supply.
Transcripts of the meetings are available at the FDA's
web page on bioengineered foods, listed above. Additional
information is available from FDA's Center for Food
Safety and Applied Nutrition (http://vm.cfsan.fda.gov/~lrd/biotechm.html).
Environmental Protection Agency
transgenic plants that are engineered for pest resistance,
e.g., Bt insect resistant corn or virus resistant squash.
In EPA terminology, these plants contain "plant-incorporated
protectants" (also known as "plant-pesticides"). EPA's
authority to regulate transgenics is based on three
The Federal Insecticide, Fungicide, and Rodenticide
Act grants the authority to regulate the distribution,
sale, use, and testing of plants and microbes containing
The Federal Food, Drug, and Cosmetics Act
empowers EPA to regulate pesticide content of foods.
Under the Toxic Substances Control Act,
EPA regulates commercial use of genetically engineered
microorganisms, e.g., a bacterium that allows a
plant to fix nitrogen or produce a novel chemical.
To implement its oversight of transgenic crops, EPA
Examines data characterizing the plant-incorporated
protectant, e.g., the biochemical nature of the
product, its mode of action, and the time and tissues
in which the product is expressed.
Reviews environmental effects (both risks and benefits)
of the proposed plant-incorporated protectant, including
effects on non-target organisms and environmental
May require a "resistance management plan", measures
to slow down development of resistance in the target
Determines whether the introduced gene or its product
are toxic, typically based on toxicity testing in
Sets tolerance levels for pesticide residues, if
there is evidence of toxicity. Because of lack of
toxicity in plant-incorporated protectants evaluated
to date, they have been exempt from this requirement.
Regulates new uses of existing pesticides, such
as use of herbicides together with herbicide-resistant
OSTP proposes updates to U.S. regulatory system
In August 2002, the U.S. Office of Science and Technology
Policy formally proposed several changes in the way
USDA, FDA, and EPA regulate biotechnology-derived crops.
The main points of the proposed actions are
- To encourage biotech crop developers to submit
protein safety information (especially concerning
allergenicity and toxicity) at an earlier stage in
the evaluation process than currently practiced.
- To strengthen field testing protocols for certain
types of biotechnology-derived products to minimize
the potential for gene flow to seed and commercial
- To establish procedures to address potential intermittent,
low level presence in food or feed of new proteins
that have not completed regulatory review.
Published in the Federal Register, Vol. 67, No. 149.
FR Doc. 02-19746, Filed 8-1-02.
NAS Committee Report
In April 2000, a U.S. National Academy of Sciences
panel released a report calling for changes in the regulatory
process for transgenic crops. The report, authored by
the Committee on Genetically Modified Pest-Protected
Plants, National Research Council, is entitled "Genetically
Modified Pest-Protected Plants: Science and Regulation"
(http://books.nap.edu/catalog/9795.html). As indicated
by the title, the report addressed only transgenic varieties
engineered to protect plants from insects and diseases.
Among the conclusions in the 261-page report:
There is no evidence that foods produced from transgenic
crops currently on the market are unsafe as a result
of the inserted genetic material.
Pest-resistant transgenic plants are useful in
reducing the amount of chemical pesticides applied,
and may therefore lead to greater biodiversity in
Regulatory agencies (USDA, FDA, and EPA) should
more closely coordinate their regulatory and approval
activities, and should make the process more open
to the public.
Long-term impacts of transgenic crops on ecosystems
and human health should be monitored.
Two EPA categorical exemptions should be revoked:
(1) for plants with viral coat protein genes to
provide virus resistance; and (2) for plants transformed
with genes from a sexually compatible plant. The
panel felt that these categories of transgenic crops
could have negative effects in some cases, and should
not be exempted from a rigorous evaluation.
Better methods of identifying potential allergens
should be developed.
Clinton Administration initiatives on ag biotech
A series of steps to strengthen science-based regulation
of ag biotech products was announced by the Clinton
Administration on May 3, 2000. These initiatives include:
A 6-month assessment of federal environmental regulations
pertaining to agricultural biotechnology, to be
conducted by the Council on Environmental quality
and the Office of Science and Technology Policy.
A proposed requirement by the Food and Drug Administration
(FDA) that it be informed at least 120 days before
GM crops or products are placed on the market. This
will replace the current voluntary consultation
process. (On Jan. 17, 2001, FDA formally proposed
this change in regulations.) (Food and Drug Administration
Center for Food Safety and Applied Nutrition http://vm.cfsan.fda.gov/~lrd/biotechm.html)
Development of FDA guidelines for voluntary labeling
of foods containing or not containing transgenic
ingredients. (On Jan. 17, 2001, FDA formally proposed
this guidelines.) (Food and Drug Administration
Center for Food Safety and Applied Nutrition http://vm.cfsan.fda.gov/~lrd/biotechm.html)
An expanded competitive grants program by USDA
and FDA on health and safety issues.
Improved public education activities on the nature
of the US regulatory process.
USDA Committee Begins 2-Year Review
In March 2000, Secretary of Agriculture Dan Glickman
convened a 38-member panel to review USDA's role in
developing and regulating transgenic crops. The committee,
which includes scientists, farmers, and representatives
of consumer groups and seed companies, is expected to
take two years to complete its assignment. Among the
issues the panel will address are the use of "terminator"
technology, developed by USDA to prevent unauthorized
reproduction of transgenic seeds.
In addition to federal regulation, some states require
additional review and approval of transgenic crops at
the state level. State agencies work together with APHIS
to monitor transgenic field testing.
At present, Colorado does not require a separate state
review of transgenic crop varieties. A description of
Minnesota's regulation of transgenic crops is available
In this age of global trade, international agreements
can have a major impact on regulating the movement of
products between countries. Two developments that may
effect the import and export of transgenic crops and
food are described below.
World Trade Organization (WTO) members have
agreed to a wide range of policies aimed at creating
and maintaining free and open international trade. For
example, if a country blocks import of beef produced
with growth hormones, an exporting country could file
a protest with the WTO. WTO's position on transgenic
food products has not been finalized, but will likely
be very important in regulating the future trade in
A landmark International Biosafety Protocol
to regulate international trade of genetically modified
organisms (GMOs) was approved by representatives of
130 countries at a meeting in Montreal, Canada in January,
2000. The agreement, an outgrowth of the Convention
on Biological Diversity (Rio Earth Summit, 1992), was
hailed as a step forward by both proponents and opponents
of transgenic crops. The protocol still requires ratification
by 50 nations before it goes into effect. Its major
International shipments that "may contain" transgenic
food products must be so labeled. The exact nature
of the genetic modification need not be specified,
but the agreement calls for negotiations on more
specific labeling requirements in the future. This
labeling provision applies only to large-scale shipments,
and does not affect labeling requirements on consumer
products, which are determined by each country.
Governments may use the so-called "precautionary
principle" to bar import of a transgenic product
even in the absence of conclusive evidence that
the product is not safe. However, the protocol does
not override other international agreements, including
the WTO, which requires that import decisions be
To assist countries in making import decisions,
a database will be established to make available
uniform information on transgenic crop varieties.
Perhaps most importantly, the protocol establishes
an international framework for regulating international
trade in transgenic crops, and demonstrates that
a balance can be found between different points
of view in this often polarized debate.