U.S. Ponders Rules On Biotech Food, Despite Scientific
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U.S. Ponders Rules On Biotech Food, Despite Scientific Findings
Investor's Business Daily. Tuesday April 25, 2000
Last month, biotech stocks tumbled after
President Clinton and British Prime Minister Tony Blair announced
that biotech companies should make "raw fundamental data"
public. After Clinton clarified his statement, some stocks rebounded.
But biotechnology may not recover as easily from new rules on the way
this year from U.S. regulatory agencies. And stocks may not be the
only casualties. In the next two months, observers believe the Food
and Drug Administration is likely to put more burdens on makers and
growers of foods from biotechnology, even if those products
haven't been shown to pose greater risks than ordinary food.
This may push up costs and "make
biotechnology impossible to apply to the world's food production
needs," said Henry Miller, former head of the FDA's now-defunct
Office of Biotechnology and senior research fellow at the Hoover
Institution. Over 1,000 scientists, including Nobel Laureates James
Watson and Norman Borlaug, have signed a statement praising
biotechnology as having the potential to feed the developing world,
make food more nutritious and protect the environment by reducing the
use of chemicals and acreage to grow crops.
The FDA is now taking another look at its 1992
policy on new food crops: a policy based on the findings of
scientific groups like the National Academy of Sciences that
biotechnology isn't inherently more dangerous than common breeding
techniques. Under this policy, new plant varieties are only subject
to FDA review or labeling if they create new substances that aren't
"generally recognized as safe." "Up to this point, we
are standing by our 1992 policy," said FDA environmental
scientist Jeanette Glew, but she confirmed that parts of the rule may
change in the next two months.
The FDA's policy was recently praised by a congressional report from
the chairman of the House Science Subcommittee on Basic Research,
Nick Smith, R-Mich. "(The) FDA should maintain its current
science-based policy of regulation based on the characteristics of a
food product, and not by the means by which it was created,"
concluded the report, "Seeds of Opportunity." The report
also criticized Agriculture Department and Environmental Protection
Agency rules that, unlike the FDA policy, "discriminate against
the products of biotechnology" and "create disincentives
for researchers and plant developers."
But pressure from anti-biotech activists and European countries
import biotech products may sway the FDA to change course. Even some
industry groups want more rules. The National Food Processors
to make the FDA's voluntary consulting process for those who come up
plants mandatory to "increase public confidence," said its
president, John Cady,
at last week's National Food Policy Conference in Washington.
The NFPA has argued that this won't change things that much, since
biotech companies already consult with the FDA anyway. But Miller
NFPA's position a "shortsighted, fatuous view." The move,
he added, "reverses the FDA's risk-based
approach and embraces the myth that there's something special and
something more worrisome about biotechnology." Miller said the
mandate also undercuts the U.S.' ability to defend biotech in trade
disputes. He noted that at the recent meeting in Japan of the Codex
Alimentarius Commission, which sets food safety standards for the
World Trade Organization, FDA officials made no attempt to defend the
agency's current policy of not singling out biotech crops for special
Some see more restrictions coming. "It gives the FDA added
power, and it could be abused in time," said Gregory Conko, a
food expert at the Washington-based
Competitive Enterprise Institute. Already, Consumers Union Washington
co-director Mark Silbergeld uses the "consumer
confidence" argument to call for
labeling of nearly all foods with biotech ingredients - even if there
apparent safety concerns. But C.S. Prakash, head of Tuskegee
for Plant Biotechnology Research, says that could be costly.
regulations in whatever form to appease some consumers is not the
right thing to
do," Prakash said. "Who's going to bear the cost for all
that? Why do I have to
pay an increased amount for cornflakes I buy this morning just
sections of society demand (it)?"
Prakash notes that the FDA already requires labeling if a biotech
food contains a known allergen or different nutritional content. He
adds that "no food is
entirely risk-free." But biotech "creates a whole host of
new risks," argued
Joseph Mendelson, legal director of the Center for Food Safety. The
suing the FDA to force it to require labeling and premarket approval
biotech food crops. "When you genetically engineer one of the
plants it's not a
precise science," he said. "You don't know whether it's
going to potentially
create a new toxin or rev up an existing toxin to a point where it's
powerful and dangerous than it had been previously."
Prakash responds that common cross-breeding techniques mix thousands
genes together with sometimes unknown results. New varieties of
grown celery have been linked to rashes in farm and grocery workers.
opposition to biotechnology takes on almost religious overtones. Wes
president of the Salina, Kan.-based Land Institute, compared biotech
the Biblical story of "partaking of the fruit of the tree of
knowledge and being
denied access to the tree of life." In January, he argued for
wisdom path" rather than the "path of human
Yet much of what today is called nature has been shaped largely by
wheat, corn (maize), rice, oats, barley and wild rye grass, were very
plants from the staple crops of today," wrote Encyclopaedia
editorial vice president, Charles Van Doren, in "A History of
original wild plants were hardy, but unaltered they could not have
enough grain to feed the hunger of the human race."