August 9, 2000
Fact Sheet
Food Safety - Regulating Plant Agricultural Biotechnology in the U.S.
Following is a fact sheet on the U.S. regulation of agricultural
biotechnology products that has been released by the Department of
State. It was prepared in cooperation with the Department of
Agriculture, Environmental Protection Agency, Food and Drug
Administration, U.S. Agency for International Development, Department
of Commerce and the Office of the U.S. Trade Representative.
Consumers worldwide are rightly concerned about the safety of the
foods they eat. This concern has intensified with advancements in
bioengineered foods. Under a policy developed in 1986, three lead
federal agencies -- the U.S. Department of Agriculture's Animal and
Plant Health Inspection Service (USDA-APHIS), the Department of Health
and Human Services' Food and Drug Administration (FDA), and the
Environmental Protection Agency (EPA) -- have the responsibility for
implementing the nation's biotechnology regulatory framework. Within
this framework, the U.S. regulatory process is constantly being
reassessed and refined for all foods, both bioengineered and
traditional.
The United States has more than a decade of experience in regulating
bioengineered foods. About 50 varieties of bioengineered food crops
have gone through the U.S. government regulatory procedures, and
thousands of foods containing ingredients from these bioengineered
crops are currently on the U.S. market. This fact sheet outlines the
five regulatory procedures that occur from the time a scientist has an
idea for a potentially marketable bioengineered plant product to when
the product finally ends up in the local food market.
Pre-submission Discussions
Biotech regulation at the federal level starts as the product nears
the first field test after development in the laboratory. Early in the
process, the developer of a new plant line discusses the product with
the three regulatory agencies to determine the kinds of data and
information that will be necessary to support the regulatory review.
While not required, these pre-submission consultations are strongly
encouraged so as to avoid problems and delays later.
Field Trials Approvals
USDA-APHIS regulates the development and field testing of genetically
engineered plants. Plant breeders normally do several years of field
testing to evaluate virtually every element involved in growing a new
variety that has been developed in the laboratory or greenhouse --
from its ability to resist disease to a variety of individual
characteristics about the plant. USDA-APHIS regulations cover this
field testing since they provide procedures for obtaining a permit or
for providing notification prior to importation, interstate movement,
or release of a "regulated" article into the United States. Regulated
articles are living organisms, primarily plants and microorganisms,
and products altered or produced through genetic engineering that
could be considered plant pests or that could pose some risk to
plants. Even if a developer only wants to ship genetically engineered
seed interstate, USDA-APHIS must be notified.
To satisfy USDA-APHIS regulatory requirements, a field test must be
conducted in such a way that neither the genetically engineered plant
nor its offspring establishes or survives beyond the field trial in
either the agricultural or nonagricultural environment. Specific
precautions must be taken to prevent the escape of pollen, plants, or
plant parts from the field-test site. The field-test plot must be
monitored the following year to assure that no "volunteer" plants
survive and grow on the plot. In addition, once USDA-APHIS approves a
new biotechnology-derived plant for field testing, agency officials
and their state counterparts may inspect the field-test site before,
during and after a test to ensure that the test is conducted and
managed safely.
Petitioning USDA-APHIS For "non-regulated Status"
After several years of laboratory and field testing, a developer may
decide to commercialize the genetically engineered plant variety and
petition USDA-APHIS to be released from regulatory oversight.
Following review of all materials -- from field-test reports to the
scientific literature and disease lists -- USDA-APHIS will make a
determination that the product is no longer a "regulated article" if
the new plant variety poses no significant risk to other plants in the
environment and is as safe to use as more traditional varieties. This
determination enables the new plant to be cultivated, tested or used
for crop breeding without any additional USDA-APHIS action. Both the
petition and the accompanying environmental assessment developed by
USDA-APHIS are published and made available for public comment. This
process normally takes about 10 months once the agency receives all
the information it needs. Civil and criminal penalties can be levied
for failure to comply with USDA-APHIS regulations. In making its
determination, USDA-APHIS examines potential environmental
consequences such as:
- Possible plant pest consequences. USDA-APHIS examines the biology
of the plant (i.e., is the plant an annual or perennial, where does it
grow naturally, what is its life cycle), the genetics of the plant,
and the nature and origin of the genetic material used. It also
examines the genetically engineered plant's possible effects on other
organisms in the environment and on agricultural products, assessing
its potential for creating plant pest risk such as new virus diseases,
altered disease and pest susceptibilities of the new plant and the
potential for gene transfer to a wild plant relative that might create
a weed problem.
- Possible consequences to other organisms. USDA-APHIS must consider
whether the biotech crop can affect wildlife, including birds and
mammals that could feed on crops. The effects on beneficial organisms
such as bees, endangered species, and other non-target organisms are
also evaluated. This analysis includes looking at the consequences of
adding the new gene, such as the production of new enzymes or changes
to plant metabolism.
- Possible weed consequences. USDA-APHIS considers whether the
modified crop has the potential to become a weed. It examines the
unmodified crop plant for weediness characteristics such as ease of
seed dispersal, whether seeds survive over winter, and the viability
of the seeds. Then the new traits that have been introduced are
evaluated for their potential to enhance the weediness of the plant.
EPA Regulation of Crops with Pest Control Properties
If a plant is genetically engineered to express a protein with pest
control properties, the Environmental Protection Agency has oversight
responsibilities throughout the development, commercialization, and
post-commercialization phases. An example would be corn (maize)
expressing a protein to control corn borer, often referred to as Bt
corn. In the case of herbicide-tolerant crops, the plant itself does
not have pest control properties but is made to resist a chemical that
would normally kill it. For these plants, EPA not only looks at the
environmental safety of a herbicide, but also determines whether
applying the herbicide poses risks to food or feed safety that would
require specific labeling and determines the maximum residue levels
("tolerances") that would be safe for the public to consume. In those
cases, detailed herbicide residue data must be submitted for the
herbicide-tolerant crop.
Development phase: When a developer of a pesticidal plant variety
seeks to conduct nonfood and non-feed trials on greater than 10 acres
of terrestrial or one acre of aquatic use, the developer consults with
EPA staff regarding data necessary to obtain a testing permit (termed
an "Experimental Use Permit," or EUP) and data that should be
generated during EUP testing for the next step, which is a review to
determine whether a product can be registered for use as a pesticide
in the United States. EUPs are required at the development phase for
all crops that may enter the food supply. EUP applications must
provide "sufficient" information to allow for a determination that the
proposed uses will not result in "unreasonable adverse effects," as
defined in the U.S. pesticide law. Field tests during an EUP are
usually required to be carried out with strict containment measures to
reduce environmental and human health concerns (e.g., crop destruction
after field testing). The law allows EPA 120 days to make a
determination on issuance of an EUP. The public is invited through
published notices to comment on the EUP request.
Commercialization phase: Unless specifically exempted, all pesticides,
including those contained within living plants, must be reviewed by
and registered with EPA before they can be sold or distributed. For
registration of pesticides, EPA must consider data on all potential
human and environmental risks and find that the pesticide "will not
generally cause unreasonable adverse effects." It generally takes a
year for EPA to review a "complete" information package for the
product and reach a decision. A complete package typically includes
information on product characterization, health effects (toxicology),
non-target organism effects, and the fate of the pesticide in the
environment. Insect resistance management -- the likelihood of insects
to develop a resistance to the bioengineered plant -- also is
evaluated. Public comment is invited again.
Product characterization. For example, EPA considers the source of
the gene, how the gene is expressed, the biology of the recipient
plant, and the nature of the pesticide produced.
Health effects. Dietary intake is presumed to be a major route of
exposure for food and feed plants bioengineered to produce pest
control substances. For all food or feed plants producing pesticidal
substances, EPA examines data on acute oral studies obtained through
laboratory experiments using mice. EPA also assesses potential
allergenicity and digestibility of the new pesticidal protein.
Environmental fate. EPA reviews data on the rate of degradation of
the pesticidal protein in plant tissue in the soil. EPA considers any
potential for gene transfer to weedy or wild relatives by
cross-pollination as well as the geographic proximity of the
cultivation area to related cultivars or weedy relatives that can
cross-pollinate.
Effects on non-target organisms. For bioengineered plants,
pesticidal substances (usually a protein) are contained within the
plant. Thus, exposure of non-target organisms to the pesticidal
substance occurs mainly when non-targets feed on the pesticidal
plants. EPA considers whether the introduced pesticidal substance is
toxic to wildlife, beneficial insects, fish, or other organisms and,
if so, whether those organisms will be exposed to the protein. For
example, Bt proteins have been tested at doses typically 10 to 100
times the expected exposure from the pesticidal plant. The tests are
carried out with a range of non-target insects such as honeybees,
green lacewing, ladybird beetles, and parasitic wasps, and with other
organisms such as earthworms, fish, birds and rodents.
In addition to data requirements for pesticide registration, EPA must
review all animal and human dietary risks of the pest control protein
to determine whether a tolerance limit should be set on the amount of
protein in food derived from the improved plant. Public comment is
invited. If there is already substantial data on the safety of the
protein and a history of safe use, the developer may request an
exemption from the tolerance requirement. Such exemptions are not
automatically granted.
Post-commercialization phase: The U.S. pesticide law gives EPA
authority to amend or revoke existing registrations in the event
"unreasonable adverse effects" have been observed. In addition, EPA
can impose new measures as new information becomes available. For
example, for purposes of insect resistance management, beginning in
the 2000 crop year, growers must plant an area of non-Bt corn equal to
20 percent of their acreage, along with their Bt corn seeds. For Bt
corn grown in cotton areas, farmers must plant at least 50 percent
non-Bt corn. This provides what is called a "refuge" and is used to
manage the genetics of pest insect populations to prevent the
development of resistance to Bt in insects feeding on the corn.
FDA Review of Food and Feed Safety
The Department of Health and Human Services' Food and Drug
Administration has the responsibility for the safety of foods and
feeds. FDA meets with the developer of a product and provides guidance
as to what studies FDA considers appropriate to ensure food and feed
safety. This process may begin before, during, or after the developer
has initiated field studies or discussions with the other agencies,
depending on the kinds of questions the developer or FDA may have
about the product.
Developers send FDA documents summarizing the information and data
they have generated to demonstrate that a bioengineered food is as
safe its conventional counterpart. The documents describe the genes
they use; whether they are from a plant whose food is known to produce
allergic reactions in some people; the characteristics of the proteins
made by the genes, including their biological function; their relative
safety in humans and animals; and how much of them will be found in
the food. Developers tell FDA whether the new food contains the
expected levels of nutrients or toxins and any other information about
the safety and use of the product.
The type of studies a developer will perform will vary depending on
the characteristics of the food product and the kinds of modifications
introduced into the food crop. The studies generally examine whether
the introduction of the genetic material into the plant caused any
unexpected effects by analyzing the composition of the food, paying
particular attention to levels of known toxicants and significant
nutrients. In the case of a new protein, they check to determine
whether:
- It is substantially the same as other proteins commonly present in
food and whether it is present in comparable levels.
- It comes from a commonly allergenic food, such as milk, eggs,
wheat, fish, tree nuts and legumes. If so, it would be presumed to be
an allergen unless the sponsor could demonstrate otherwise to FDA's
satisfaction. If the developer could not demonstrate that the protein
was not an allergen, the agency either would require that the food be
labeled to indicate the presence of the allergen or, in situations in
which labeling would not be considered adequate to ensure safety, the
agency would not allow marketing of the food.
- It is rapidly digested to minimize the likelihood that it will
become allergenic.
The current FDA consultation process described above is voluntary,
although, to date, all companies have made use of it prior to
commercializing any bioengineered food in the United States. FDA is
planning to publish a proposed regulation that will, when finalized,
make it mandatory for a developer wishing to market a bioengineered
food product to notify and provide information about the food to FDA
at least 120 days before marketing. At the end of this process, if FDA
is satisfied with the information it has received and has found no
safety or other regulatory concerns pertaining to the food, FDA will
provide a letter to the developer confirming that it has no more
questions related to the food and feed safety of the product.
To make sure that consumers also have access to product information,
FDA will post information and the agency's conclusions on the FDA Web
site, consistent with applicable disclosure laws.
However, should concerns arise after a product is on the market, FDA
has the authority to remove immediately any food from the market that
it deems unsafe.
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