FDA Documents Show They Ignored SOY GMO Safety Warnings From Their Own Scientists

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FDA Documents Show They

Ignored GMO

Safety Warnings From Their Own Scientists

 

 

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Alliance for Bio-Integrity

P.O. Box 110, Iowa City, IA 52244-0110

Tel: 515-472-5554; Fax:515-472-6431

www.bio-integrity.org

Contact: Steven Druker, ph. 515-472-5554,

or Bob Roth, ph. 515-469-5081

For Immediate Release:

June 24, 1999

 

Lawsuit in U.S.A. Uncovers Disagreement

Within FDA Over Safety of Biotech Foods

 

Agency Contradicted Own Experts in Approving Genetically Engineered

Foods

-- Misrepresented Facts in Order to Promote U.S. Biotech Industry

 

Statement by Steven M. Druker, J.D., executive director of the Alliance

for Bio-Integrity, coordinator of the lawsuit against the FDA to obtain

mandatory safety testing and labeling of gene-spliced foods, and an

attorney on the case (in collaboration with the Legal Department of the

Center for Technology Assessment in Washington, D.C.).

 

In May 1998, a coalition of public interest groups, scientists, and

religious leaders filed a landmark lawsuit against the U.S. Food and

Drug

Administration to obtain mandatory safety testing and labeling of all

genetically engineered foods (Alliance for Bio-Integrity, et. al. v.

Shalala). Nine eminent life scientists joined the coalition in order to

emphasize the degree to which they think FDA policy is scientifically

unsound and morally irresponsible. Now, the FDA's own files confirm how

well-founded are their concerns. The FDA was required to deliver copies

of these files--totalling over 44,000 pages--to the plaintiffs'

attorneys.

 

False Claims and a Policy at Odds with the Law

 

The FDA's records reveal it declared genetically engineered foods to be

safe in the face of disagreement from its own experts--all the while

claiming a broad scientific consensus supported its stance. Internal

reports and memoranda disclose: (1) agency scientists repeatedly

cautioned that foods produced through recombinant DNA technology entail

different risks than do their conventionally produced counterparts and

(2) that this input was consistently disregarded by the bureaucrats who

crafted the agency's current policy, which treats bioengineered foods

the

same as natural ones.

 

Besides contradicting the FDA's claim that its policy is science-based,

this evidence shows the agency violated the U.S. Food, Drug and

Cosmetic

Act in allowing genetically engineered foods to be marketed without

testing on the premise that they are generally recognized as safe by

qualified experts.

FDA Scientists Protest Attempt to Equate Genetic Engineering with

Conventional Breeding

 

The FDA admits it is operating under a directive "to foster" the U.S.

biotech industry; and this directive advocates the premise that

bioengineered foods are essentially the same as others. However, the

agency's attempts to bend its policy to conform with this premise met

strong resistance from its own scientists, who repeatedly warned that

genetic engineering differs from conventional practices and entails a

unique set of risks. Numerous agency experts protested that drafts of

the

Statement of Policy were ignoring the recognized potential for

bioengineering to produce unexpected toxins and allergens in a

different

manner and to a different degree than do conventional methods.

 

According to Dr. Louis Priybl of the FDA Microbiology Group, "There is

a

profound difference between the types of unexpected effects from

traditional breeding and genetic engineering which is just glanced over

in this document." He added that several aspects of gene splicing

"...may

be more hazardous."

 

Dr. Linda Kahl, an FDA compliance officer, objected that the agency was

"...trying to fit a square peg into a round hole ... [by] trying to

force

an ultimate conclusion that there is no difference between foods

modified

by genetic engineering and foods modified by traditional breeding

practices." She said: "The processes of genetic engineering and

traditional breeding are different, and according to the technical

experts in the agency, they lead to different risks."

 

Moreover, Dr. Jim Maryanski, the FDA Biotechnology Coordinator,

acknowledged there is no consensus about the safety of genetically

engineered foods in the scientific community at large, and FDA

scientists

advised they should undergo special testing, including toxicological

tests.

 

Misrepresenting the Facts in Order to Approve the Foods

 

Nonetheless, so strong was the FDA's motivation to promote the biotech

industry that it not only disregarded the warnings of its own

scientists

about the unique risks of gene-spliced foods, it dismissed them and

took

a public position that was the opposite. Its official policy asserts:

"The agency is not aware of any information showing that foods derived

by

these new methods differ from other foods in any meaningful or uniform

way...." Thus, although agency experts advised that genetically

engineered foods should be subjected to special testing, the

bureaucrats

in charge of the policy proclaimed these foods require no testing at

all.

 

Violating Federal Law

 

Besides violating basic canons of ethics, the FDA's behavior flagrantly

violates the U.S. Food, Drug and Cosmetic Act, which mandates that new

food additives be established safe through testing prior to marketing.

While the FDA admits that bioengineered organisms fall under this

provision, it claims they are exempt from testing because they are

"generally recognized as safe" (GRAS), even though it knows they are

not

recognized as safe even by its own scientists let alone by a consensus

in

the scientific community.

 

Further, the statute prescribes that additives like those in

bioengineered foods can only be recognized as safe on the basis of

tests

that have established their harmlessness. But no such tests exist for

gene-spliced foods. So, although the GRAS exemption was intended to

permit

marketing of substances whose safety has already been demonstrated

through

testing, the FDA is using it to circumvent testing and to approve

substances based largely on conjecture--conjecture that is dubious in

the

eyes of its own and many other experts.

 

Consequently, every genetically engineered food in the U.S. is on the

market illegally and should be recalled for rigorous safety testing.

The

FDA has deliberately unleashed a host of potentially harmful foods onto

American dinner tables in blatant violation of U.S. law.

 

 

 

 

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