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April 4, 2000


National Academy Report on Ag Biotech


- http://www.agbioworld.org, http://agbioview.listbot.com

U.S. Regulatory System Needs Adjustment As Volume and Mix of
Transgenic Plants Increase in Marketplace

(The National Academy of Sciences, USA has just release this
important report today on biotech. The full report can be accessed at
http://www.nas.edu/. ------ Date: April 5, 2000 Contacts: Bill
Kearney, Media Relations Associate, Megan O'Neill, Media Relations
Assistant (202) 334-2138; e-mail )

WASHINGTON -- Even given the strengths of the U.S. system governing
transgenic plants, regulatory agencies should do a better job of
coordinating their work and expanding public access to the process as
the volume and mix of these types of plants on the market increase,
says a new report from the National Academies' National Research
Council. The committee that wrote the report emphasized it was not
aware of any evidence suggesting foods on the market today are unsafe
to eat as a result of genetic modification. And it said that no
strict distinction exists between the health and environmental risks
posed by plants genetically engineered through modern molecular
techniques and those modified by conventional breeding practices.

The committee called on the U.S. Environmental Protection Agency
(EPA), U.S. Department of Agriculture (USDA), and Food and Drug
Administration (FDA) to quickly come to an agreement on each agency's
role in regulating plants that have been genetically modified to
resist pests. It also said that any new rules should be flexible so
they can easily be updated to reflect improved scientific

"Public acceptance of these foods ultimately depends on the
credibility of the testing and regulatory process," said committee
chair Perry Adkisson, chancellor emeritus and distinguished professor
emeritus, Texas A&M University, College Station. "The federal
agencies responsible for regulating transgenic plants have generally
done a good job, but given the current level of public concern and
following our review of the data, it is the committee's belief that
the agencies must bolster the mechanisms they use to protect human
health and the environment. However, I must also emphasize that we
believe it is the properties of a genetically modified plant -- not
the process by which it was produced -- that should be the focus of
risk assessments."

As the volume of transgenic products increases, more research will
be needed to examine and better detect their effects on human health
and the environment so that the agencies will have a more refined
scientific basis for making decisions, the committee said.

Improving Pest Resistance

Farmers have been trying to minimize their losses from crop pests
for hundreds of years by using conventional breeding practices, such
as hybridization, to develop crops with desirable traits. Some types
of worms cause an estimated $7 billion in crop losses per year in the
United States; the damage from insects is even more severe. In the
past two decades, scientists have used the tools of advanced
molecular biology to more precisely alter plants to be pest
resistant. Scientists use these methods to introduce genes that endow
plants with pesticidal traits, creating what are known as transgenic
pest-protected plants. These genes may come from similar, sexually
compatible species or from completely unrelated organisms. Transgenic
plants have been grown commercially since 1995, and their use has
increased dramatically since then. In 1999 alone, more than 70
million acres of transgenic crops were planted in the United States.

But some scientists and members of the public have expressed concern
that the genetic engineering of plants could result in unsafe foods,
do irreparable harm to beneficial organisms, and spur the
uncontrollable growth of weeds. Given the dramatic increase in
commercial planting of genetically engineered crops and the safety
concerns they raise, the Research Council decided to initiate a
review of the scientific data on potential health and environmental
risks and the use of this data in the regulatory process.

Health-Related Concerns

Thus far, only in very rare circumstances have pest-protected plants
caused obvious health or environmental problems. For example,
although a human allergic reaction to a new gene product has never
been documented for a commercially available transgenic
pest-protected plant, one such incident did occur at the research
stage. In that study, people with a known allergic reaction to Brazil
nuts experienced a similar reaction when they were exposed in
skin-prick tests to soybeans containing a gene transferred from the
Brazil nut.

Priority should be given to developing improved methods for
identifying potential allergens, specifically focusing on new tests
relevant to the human immune system and on more reliable animal
models, the committee said. Changes in plant physiology and
biochemistry should be monitored during the development of
pest-protected plants. And because the potential exists for
transgenic plants to have increased levels of toxic plant compounds,
EPA, USDA, and FDA should create a coordinated database that lists
information about natural plant compounds of dietary or toxicological
concern, to aid researchers who monitor concentrations of these
compounds in such plants.

Environmental Concerns

In examining ecological concerns, the committee looked at the
possibility that transgenic plants could affect organisms which are
not the target of the pesticidal trait, the potential transfer of
novel genes from one type of plant to another, and the evolution of
new strains of immune pests.

Both conventional and transgenic pest-protected crops could impact
so-called nontarget species, such as beneficial insects, but that
impact is likely to be smaller than that from chemical pesticides,
the committee said. In fact, when used in place of chemical
pesticides, pest-protected crops could lead to greater biodiversity
in some geographical areas. The committee called for more research to
examine these issues.

The highly publicized report of monarch butterflies being poisoned
by pollen from genetically engineered corn is an example of an issue
that needs to be researched further and will require rigorous field
evaluations, the committee said. In that particular report,
researchers showed that pollen from corn which had been genetically
engineered to produce Bacillus thuringiensis (Bt) toxins -- a type of
insecticide -- slowed the growth, and sometimes killed, monarch
caterpillars when enough pollen was placed on milkweed leaves fed to
them in a laboratory. Follow-up studies are needed in the field where
pollen density might be lower and the toxin might be deactivated by
environmental factors.

Concern also surrounds the possibility that genes for resisting
pests might be exchanged among cultivated crops and their weedy
relatives, potentially exacerbating weed problems -- a high-cost
nuisance for farmers and potential threat to the ecosystem. The
committee recommended further research to identify plants with weedy
relatives, to assess rates at which pest-resistance genes might
spread, and to develop techniques that decrease this likelihood.

Another ecological concern is the potential for pests to evolve and
develop a resistance to plants that have been genetically modified to
kill them. The committee concluded that the ability of pests to adapt
and develop resistance should continue to be evaluated. Such an
occurrence could have a number of potential environmental and health
consequences, including a return to the use of more harmful chemical
pesticides. Strategies to manage the development of resistance in
pests should be encouraged for all uses of a pesticide, be it in a
spray form or produced by a plant.

Improving the Regulatory Framework

To improve coordination, EPA, USDA, and FDA should develop a
memorandum of understanding for regulating transgenic pest-protected
plants that identifies regulatory issues within the purview of each
agency as well as issues for which more than one agency has
responsibility, the committee said. The memorandum also should
establish a process to ensure appropriate and timely exchange of
information between agencies. For 14 years, the agencies have
formulated policies for genetically modified foods under guidelines
set forth in the 1986 Coordinated Framework for the Regulation of
Biotechnology. The framework gives each agency a role in setting
safety standards based on legal jurisdictions at the time. But the
committee said the scope of each agency's oversight needs to be
clarified, especially when a new product is to be reviewed by more
than one agency.

Additionally, the committee took issue with exemptions in EPA's
proposed 1994 rule for regulating certain transgenic pest-protected
plants. EPA proposes to grant categorical exemptions for all plants
that have been given a new gene from a sexually compatible plant, and
for plants expressing proteins that are derived from a virus, known
as viral-coat proteins. But in the first instance, the committee said
that in some cases the transfer and manipulation of genes between
sexually compatible plants could potentially increase human and
environmental exposure to high levels of toxins. Secondly, while
plants with viral-coat proteins may be safe to eat, there are
environmental issues to consider because of their potential to
crossbreed with weedy relatives. The committee urged EPA to
reconsider its plans to grant categorical exemptions for these
transgenic plants.

The committee also recommended that the agencies monitor ecological
impacts of pest-protected crops on a long-term basis to ensure the
detection of problems that may not have been predicted from tests
conducted during the registration and approval process.

A more open and accessible regulatory process is needed to aid the
public in understanding the benefits and risks associated with
transgenic pest-protected plants, the committee concluded. To
increase access to the process, existing Web sites for the
coordinated framework should be expanded to include more detailed
information and to link all of the agencies' decisions for any
particular product.

The committee's work was funded by the National Research Council,
which is the principal operating arm of the National Academy of
Sciences and the National Academy of Engineering. The three, along
with the Institute of Medicine, constitute the National Academies.
They are private, nonprofit institutions that provide science,
technology, and health policy advice under a congressional charter. A
committee roster follows.

Pre-publication copies of Genetically Modified Pest-Protected
Plants: Science and Regulation are available from the National
Academy Press at the mailing address in the letterhead; tel. (202)
334-3313 or 1-800-624-6242. The cost of the report is $50.00
(prepaid) plus shipping charges of $4.50 for the first copy and $.95
for each additional copy. Reporters may obtain a copy from the Office
of News and Public Information at the letterhead address (contacts
listed above).

NATIONAL RESEARCH COUNCIL Board on Agriculture and Natural Resources

Committee on Genetically Modified Pest-Protected Plants

Perry Adkisson* (chair) Distinguished Professor Emeritus Department
of Entomology, and Chancellor Emeritus Texas A&M University College

Stanley Abramson Member Arent Fox Kintner Plotkin & Kahn, PLLC
Washington, D.C.

Stephen Baenziger Eugene W. Price Professor Department of Agronomy
University of Nebraska Lincoln

Fred Betz Senior Scientist Jellinek, Schwartz & Connolly Inc. Arlington, Va.

James Carrington Professor Institute of Biological Chemistry
Washington State University Pullman

Rebecca Goldburg Senior Scientist Environmental Defense New York City

Fred Gould William Neal Reynolds Professor Department of Entomology
North Carolina State University Raleigh

Ernest Hodgson William Neal Reynolds Professor Department of
Toxicology North Carolina State University Raleigh

Tobi Jones Special Assistant for Special Projects and Public
Outreach Department of Pesticide Regulation California Environmental
Protection Agency Woodland

Morris Levin Professor Center for Public Issues in Biotechnology
University of Maryland Biotechnology Institute Baltimore

Erik Lichtenberg Professor Department of Agricultural and Resource
Economics University of Maryland College Park

Allison Snow Associate Professor Department of Evolution, Ecology,
and Organismal Biology Ohio State University Columbus


Jennifer Kuzma Study Director

* Member, National Academy of Sciences