Biotech Regulation Under Fire in the USA

May 22, 2000
Volume 78, Number 21


Public interest groups, some government officials are concerned that
testing regime for transgenic organisms is inadequate

Bette Hileman
Chemical & Engineering News

Washington, DC

Over the past two years, environmental and consumer groups have shown
increasing concern that the tests required for approval of genetically
modified organisms might be inadequate to protect health and the
environment. These groups are also concerned that biotech organisms are not
being monitored sufficiently after approval to measure what long-term
cumulative effects they may be having on wild plants and on animals and
human health.

Some government officials say the regulatory system for certain engineered
organisms that are under rapid development is ill defined or nonexistent.
It is not clear which federal agency has jurisdiction over certain classes
of organisms, such as plants that produce industrial chemicals, so
premarket tests for them have not yet been formulated. Observers also claim
that laws written for other purposes are being stretched to absurd lengths
to cover certain transgenic products like engineered salmon.

To remedy this situation, critics favor a major revision of the federal
framework for biotechnology regulation or the passage of new legislation
that would clearly delineate which agency has jurisdiction over the various
classes of organisms. The proper agency would then lay out the general
outlines of testing that the modified organisms would undergo before
approval. "It is time to rethink the roles of each agency and try to
separate boosterism from critical science," says Charles Benbrook, former
director of the National Academy of Sciences' Board on Agriculture and head
of Benbrook Consulting Services , Sandpoint, Idaho, a firm that deals with
agricultural biotech and sustainable agriculture issues.

However, many government officials continue to insist that the regulatory
framework for bioengineered organisms is adequate to protect health and the
environment. "We believe that our policies and processes in this area are
well grounded in science and that we have an excellent track record in
applying our policy," says Joseph A. Levitt, director of the Food & Drug
Administration's Center for Food Safety & Applied Nutrition . "We believe
that our oversight has been substantive, credible, and appropriate."

Three agencies currently regulate genetically engineered products under
several statutes designed to regulate pesticides, animal drugs, industrial
chemicals, conventional crops, and meat. The framework was devised in the
late 1980s and has not undergone fundamental reform since then. As a
result, "agricultural biotechnology is still regulated by a patchwork of
rules and programs with different requirements and underlying
philosophies," says Jane Rissler, senior staff scientist with the Union of
Concerned Scientists .

The Environmental Protection Agency regulates genetically engineered
microbial pesticides and crops engineered to resist insects under the
Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) and other
transgenic microbial products under the Toxic Substances Control Act.

FDA, which decided in the late 1980s that most genetically engineered foods
are not subject to regulation as food additives under the Food, Drug &
Cosmetics Act (FDCA), established an advisory process under which
industries consult with the agency about any human health risks from
transgenic foods. Until very recently, the consultations were voluntary.
Now they are mandatory.

The Department of Agriculture regulates transgenic crops under the Plant
Pest Act and engineered poultry and livestock under meat inspection laws.
For crops, USDA issues permits certifying that the plant is not a pest.

When a transgenic product does not obviously fit under one of these
statutes, the agencies consult on an ad hoc basis and decide where it
belongs. For example, FDA is now in the process of approving a fast-growing
transgenic salmon under the animal drug provisions of FDCA. FDA's reviewing
of environmental risk is a kind of "ludicrous stretching of the law," says
Anne R. Kapuscinski, a professor in the department of fisheries and
wildlife at the University of Minnesota.

Because of the variety of statutes used, the testing and information
requirements for various classes of organisms are vastly different. For
example, plants that produce a pesticide, such as corn engineered with the
Bacillus thuringiensis gene (Bt corn), are subject to a fairly strict
testing regime under FIFRA. This means that the product developer must
submit raw health and safety test data to EPA. These data are publicly
available during a 30-day notice and comment period before the crop is

For herbicide-resistant plants, FDA is the primary regulator. It conducts
consultations with the developer under FDCA in which the developer submits
only summaries of tests to FDA, and no information is readily available to
the public until after the consultation process, says Laura M. Tarantino,
deputy director of FDA's Office of Pre-Market Approval. FDA does not
publish agency-backed conclusions on the safety of genetically engineered
food, she says.

If a plant is not intended for human consumption and is not modified to
contain a pesticide, USDA is the primary agency involved in regulating it.
It issues de facto commercial permits in the form of determinations that
the plants are not pests and need no further regulation. At the same time,
it does an environmental assessment of the plant under the National
Environmental Policy Act (NEPA) . Some EPA officials say NEPA requires only
that an assessment and disclosure of impacts be done. Thus, USDA could
allow a technology that harms the environment to go forward if the
technology also produces benefits. Transgenic trees, whose pollen can often
drift hundreds of miles, will be regulated by USDA, and critics fear these
will be subject to very little scrutiny under NEPA.

Although the regulatory framework sounds uncoordinated, the involvement of
three agencies actually has a plus side, according to a government official
who does not want to be identified. The interaction among the three
agencies provides checks and balances, which are an advantage, she explains.

One of the biggest mistakes made in the regulation of transgenic organisms,
critics say, was FDA's decision to consider them "substantially equivalent"
to conventional organisms. This conclusion led to a very weak approval
process with no mandatory testing requirements for effects on human health.

Michael Hansen, research scientist at the Consumer Policy Institute, the
research arm of Consumers Union, argues that transgenic foods present
unique risks and therefore should be required to achieve a standard of
safety at least as strong as that for food additives. "Conventional plant
breeding shuffles around aberrant versions [alleles] of the same genes,
which basically are fixed in chromosomal locations as a result of
evolution," he says. "With genetic engineering, one inserts genes on an
essentially random basis, using a gene 'gun' or other techniques, into a
plant's chromosomes," he explains. "Frequently, the genes come from living
things with which the host organisms would never cross in nature," he notes.

The identity of the transferred material may be completely known. But,
Hansen says, the process of insertion of genetic material involves a number
of unpredictable elements: the number of inserts of transgenic DNA, their
precise position on a chromosome, and their functional and structural
stability. The most important of these is the random or semirandom location
of the genetic insert, he says. The insertion site can affect expression of
the inserted transgene itself as well as the expression of the genes in the
recipient organism, he explains.

"If the material inserts itself into the middle of an important gene, that
gene would functionally be turned off," Hansen states. For example, "if the
turned-off gene happens to code for a regulatory protein that prevents the
expression of some [natural] toxin, the net result of the insertion would
be to increase the level of that toxin."

Another difference between transgenic and conventional plants is that the
transgenic plants on the market contain a promoter from the cauliflower
mosaic virus that is inserted along with the desired transgene, Hansen
says. This promoter responds to signals--from other genes and from the
environment--that tell it when to switch on, and it enables the plant to
express the gene product. "But it may also change the gene expression
patterns in the recipient organism over long distances upstream and
downstream from the insertion site," he notes.

The unpredictability of the genetic engineering process can lead to a
number of adverse consequences, such as the production of a toxin that does
not normally occur in the plant, Hansen says. For example, tobacco plants
engineered to produce -linolenic acid also produced high quantities of the
toxic compound octadecatetraenoic acid [Nat. Biotechnol., 14, 639 (1996)].
Also, the response of the promoter and transgene to extreme environmental
conditions may be responsible for sudden crop failure, he says.

Furthermore, biotech crops developed thus far contain antibiotic resistance
marker genes that are not found in conventional crops. Because these marker
genes could conceivably move into bacteria and make them resistant to
antibiotics and because they are not necessary for plant function, they
should be removed before the crop is grown commercially, Hansen says.

Because of these unpredictable phenomena, Hansen wants FDA to require
additional data, including the total number of inserts of transgenic DNA,
the exact chromosomal position of each insert, the structure of each
insert, and a genetic map of at least 10,000 base pairs of the flanking
host genome DNA on either side of the insert. FDA should also require
information on the transgene's stability and its level of expression during
the growing season and over successive generations, he says.

Hansen, as well as FDA, says that better methods of testing the
allergenicity of transgenic crops are needed because virtually every gene
transfer results in the production of some new protein. The gene products
of transgenes could be novel allergens that people will start reacting to,
he says. Also, allergens can be transferred via genetic engineering from
foods that cause allergic reactions to foods that are safe. Currently,
companies test the novel gene products to see if they are digestible and if
they have a molecular sequence similar to known allergens. "Everyone agrees
that research on allergenicity testing is needed," Tarantino says.

Environmental groups are calling for the labeling of transgenic food so
that if people become allergic to a particular food, they will have some
way of knowing what they are reacting to. But, Tarantino insists, labeling
would not help because most foods contain a mixture of ingredients.

Benbrook wants tests required for the expression levels of the gene
products in different plant tissues. This would help in the development of
resistance management plans for insect-resistant plants, such as Bt corn,
he says. "To have any idea of what effect Bt corn pollen might have on
monarch caterpillars, you need to know the expression levels of Bt in the
pollen," he explains.

Environmental and consumer groups are also calling for long-term monitoring
of the effects of transgenic crops on the environment. If the crop is a
pesticidal plant like Bt corn, they want to know much more than its effects
on target insects, such as the corn borer, and the primary predators of
those insects. (This information is now required.) They want to know
effects on birds and on insects related to the target insect, such as the
monarch caterpillar. Also, because Bt is exuded from the roots of Bt corn
and lasts for months in the soil, environmentalists say tests of Bt's
effect on plant soil ecology should be done.

Recently, there has been a great deal of controversy over transgenic
salmon. The developer, a Canadian company called Aqua Bounty Farms, is
seeking FDA approval for the salmon. The fish is engineered with genes from
an ocean flounder to produce growth hormone all year round rather than just
in the warm months. It grows four to six times faster than conventional
salmon during the first year and reaches market size in 18 months, says
Elliot Entis, chief executive officer of A/F Protein Inc., the biotech firm
that owns Aqua Bounty Farms.

If FDA allows it, the transgenic salmon may be raised in net enclosures in
the ocean called net pens. Critics fear that transgenic salmon will escape
from net pens--just as farm-raised ordinary salmon routinely escape--and
mate with wild populations, destroying the gene pool of the wild fish.

Bioengineered salmon grow four to six times faster than conventional salmon
and reach market size in 18 months.

However, Entis says, his fish will be made 100% sterile before they are put
in net pens with a process that makes the fish triploid, rather than
diploid. Rebecca Goldburg, senior scientist with Environmental Defense,
says this process is likely to fail. "Past experience with trying to make
fish sterile with triploidy has not been very successful."

According to Kapuscinski, the only way to make sure fish are 100% sterile
is to examine each one individually with an automated process that costs
about 10 cents per fish. But this added expense would make salmon farming
uneconomical, Entis says.

Some critics say FDA lacks the expertise to evaluate effects of the salmon
on wild populations. FDA has the ability to conduct environmental reviews,
because it often investigates the environmental impact of new drugs,
counters John Matheson, senior regulatory review scientist at FDA's Center
for Veterinary Medicine.

The salmon assessment is a prime example of the need for a stronger
regulatory framework, Kapuscinski says.

Changes in the framework may be under way. In April, a report from the
National Research Council concluded that the pesticidal plants now on the
market are safe but suggested areas where testing of future products should
be strengthened. And in early May, the Clinton Administration decided to
review the regulatory system for transgenic organisms under leadership from
the White House Council on Environmental Quality. Acting on a request from
Secretary of Agriculture Dan Glickman, the National Research Council set up
a standing committee on agricultural biotechnology. The committee will
establish panels, some of which will study the adequacy of the regulatory

Products in search of a regulator

Several biotechnology products now under development have no current
regulatory home. For example, the Environmental Protection Agency , the
Food & Drug Administration, and the Department of Agriculture have not yet
decided who will regulate crop plants engineered to produce industrial
chemicals such as plastics precursors, says James Alwood, biotech
coordinator for the Toxic Substances Control Act . "Everyone is looking
around saying someone needs to look at these plants in some way," he says.
A decision will need to be made soon because Monsanto and DuPont are
heavily involved in research on these plants, he explains.

Similarly, the agencies have not decided what to do about plants
bioengineered to absorb and detoxify industrial wastes, Alwood says.
Regulations have to be devised for these plants because they are designed
to soak up hazardous chemicals, he explains. Another regulatory hole is
disposal of animals engineered to produce drugs. USDA is looking at them as
potential food and feed ingredients after they can no longer be used to
generate drugs, he says.

"It would be helpful if everyone had a clearer understanding of who
regulates the various products," Alwood says. "None of the statutes out
there were really designed to work with transgenic plants and animals," he
notes. Some regulators "would love new legislation," he says, so they would
not have to try "to keyhole the old laws to make them fit." He adds,
"Plants and animals present a whole different problem" than chemicals do.

Suzanne Wuerthele, EPA Region 8 biotech coordinator in Denver, points out
that the regulation of crops engineered to produce pharmaceuticals presents
difficult challenges that are not well addressed by any of the statutes.
"Here is a scary issue," she says. "Imagine growing in a rural community a
plant with pollen that contains a hormone. Would people inhale pollen that
is biologically active? What would be the effect on animals? What about the
effects on farmworkers? How do we put the right review in the right
agency?" she asks.

Actually, this is much more than a theoretical issue. So far, at least 50
field trials of plants engineered to produce pharmaceuticals have taken
place. Field trials of transgenic corn varieties that produce drugs are
going on in open, unmarked, unfenced fields, and the pollen is free to
drift into adjacent areas.

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