FDA Internal Documents Show Scientists' Disagreements Over Safety of GE Foods

December 1, 1999

Documents Show Officials Disagreed on Altered Food


WASHINGTON -- Several Food and Drug Administration officials have disagreed
with the agency's conclusion that genetically engineered foods can be
regulated in the same way as conventional food varieties, according to
internal agency memorandums read Tuesday at a public hearing.

One of the memorandums, which were written in the early 1990s, accuses the
agency of siding with industry and giving short shrift to consumers. An
advocate of labels on genetically modified food, Steven M. Druker, obtained
the documents in a lawsuit and read them at a hearing about the safety and
labeling of such foods.

The agency says there is no difference between foods modified by genetics
engineering and foods modified by traditional breeding practices. But it
organized a series of three hearings to listen to the public and a range of
panelists on the subject.

Druker made public a 1992 memorandum from Dr. Linda Kahl, a compliance
officer, to Dr. James Maryanski, the agency's Biotechnology Coordinator,
that shows the range of views that existed within the agency itself.

"The process of genetic engineering and traditional breeding are different,
and according to the technical experts in the agency, they lead to different
risks," Dr. Kahl wrote. "There is no data that addresses the relative
magnitude of risk -- for all we know, the risks may be lower for genetically
engineered foods than for foods produced by traditional breeding. But the
acknowledgment that the risks are different is lost in the attempt to hold
to the doctrine that the product and not the process is regulated."

In a separate memorandum, Dr. Louis Pribyl, an F.D.A. microbiologist,
commenting on the draft of the Federal Register notice on bioengineered
foods, reiterated Dr. Kahl's point and added that an agency document "read
very pro-industry, especially in the area of unintended effects." It is
"industry's pet idea," he said that "there are no unintended effects that
will raise the F.D.A.'s level of concern." But time and again, he said,
"there is no data to back up their contention."

Pribyl also said the document "contains very little input from consumers and
only a few answers for their concerns."

Maryanski said in an interview that the concerns of agency scientists were
old news and that the comments the scientists made were in response to an
agency request for them. "Those views were taken into account," he said.

The internal documents came to light because of a lawsuit filed against the
agency by the Alliance for Bio-Integrity, founded by Druker, a lawyer who is
the organization's executive director. Druker is conducting a one-man
campaign to force the agency to institute mandatory, rigorous safety testing
of all genetically engineered food and require labeling. Safety testing and
labeling are now voluntary.

Druker, a panelist at the hearing Tuesday, was joined by Carol Tucker
Foreman, director of the Food Policy Institute of Consumer Federation of
America, and Dr. Rebecca Goldberg, a senior scientist with the Environmental
Defense Fund, in calling for labeling and testing.

Dr. Goldberg said "the agency has not squarely placed the burden of proof on
industry to demonstrate the safety of new food, which had historically been
required in the past."

Despite rising public sentiment for more information about bioengineered
foods, which prompted the public hearings, Maryanski said there was no
reason to change the rules covering them. He maintained that as long as
developers of these foods "follow the agency's guidelines and do the testing
that is recommended," though not required, genetically engineered foods were
"as safe as any food on the market."

Until this past year, Americans -- if they thought about genetically
engineered food at all, and most did not -- seemed willing to leave these
judgments to the agency. But all around the globe, particularly in the
European Union, consumers and activists have opposed genetically modified
food with such force that American farmers have found those crops banned
from some countries.

Now many British supermarkets require labeling of genetically modified
products. The furious activity has finally had an effect in this country and
many of the questions that were not asked in 1992 are being asked now.

The original decisions on how to regulate genetically altered foods were
made by the Bush White House. Vice President Dan Quayle announced details of
a government policy for streamlining regulation of food produced through
genetic engineering, saying that because the United States "was the world
leader in biotechnology," the government wanted "to keep it that way."

Ms. Foreman said in her remarks that the process of regulating
bio-engineered food "began under a cloud of political influence peddling and
managerial bean counting and the F.D.A. has done nothing to dispel that
cloud." She said that both labeling and a mandatory pre-approval process are
essential. Several food trade associations have told the agency the same
thing. The Food Marketing Institute and the Grocer Manufacturers of America
said they "believe a mandatory consultation process would help ensure
continued consumer confidence in the F.D.A. regulatory policy" and that the
agency should set up criteria for labeling.