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#719 - Biotech: The Basics -- Final Part, 28-Feb-2001

by Rachel Massey*

Biotechnology corporations want people in the U.S. and around the
world to believe that the U.S. government has fully tested
genetically engineered crops for ecological and human health
hazards. Three federal agencies -- U.S. Food and Drug
Administration (FDA), U.S. Department of Agriculture (USDA), and
U.S. Environmental Protection Agency (EPA) -- have responsibility
for genetically engineered foods, but there is no guarantee that
a genetically engineered food sold in the U.S. has been tested
for ecological or human health effects. In the rush to promote
genetic engineering, safety testing has fallen through the

Biotechnology corporations also want us to believe that
genetically engineered foods have been embraced by the public. In
fact, genetically engineered foods are not labeled, so the public
has no knowledge -- and no choice -- about purchasing and eating

U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) issued its basic
policy statement on genetically engineered foods in 1992. Under
this policy, FDA considers genetically engineered foods to be
"generally recognized as safe" (GRAS), unless in the judgment of
the manufacturer there is some reason for concern.[2, pg. 22990]
Foods considered GRAS are not subject to pre-market safety

FDA states that the need for safety testing depends on the
characteristics of a food, not on the methods used to produce it.
In other words, the fact that a food was produced using genetic
engineering is not sufficient to trigger safety tests.[2, pgs.

FDA's 1992 policy says that a genetically engineered food must be
labeled if it "differs from its traditional counterpart such that
the common or usual name no longer applies to the new food, or if
a safety or usage issue exists to which consumers must be
alerted."[2, pg. 22991] For example, it says a tomato containing
peanut genes might need to be labeled so that people with peanut
allergies could avoid it.[2, pg. 22991] But FDA allows
biotechnology corporations to decide whether a hazard of this
sort exists. Under FDA's no-labels policy, we can find out the
fat, cholesterol, sodium, potassium, carbohydrate, and protein
content of our breakfast cereal but we can't find out whether it
contains antibiotic-resistance genes, viral promoters, or
proteins normally produced only by bacteria. (See REHN #716,
#717, #718.)

In 1998 a coalition of non-governmental organizations,
scientists, and others filed a lawsuit against FDA for failing to
fulfill its regulatory duties. During the suit, FDA was forced to
release internal documents that showed FDA staff scientists had
strongly opposed the 1992 policy.[3] (See REHN #685.)

The lawsuit also forced FDA to release details of its safety
evaluation of the first genetically engineered food that entered
U.S. supermarkets, the Flavr Savr tomato. Calgene, the company
that developed the Flavr Savr, submitted three safety tests to
FDA in which rats were fed engineered tomatoes. After
twenty-eight days of the Flavr Savr tomato diet, researchers
examined the rats' stomachs. The three studies produced
inconsistent results that Calgene was unable to explain. The
first study showed no unusual effects. In the second study, some
of the rats fed genetically engineered tomatoes developed gastric
erosions (damage to the lining of the stomach). In the third
study, gastric erosions appeared in some of the rats fed
genetically engineered tomatoes AND in some of the rats fed
ordinary tomatoes.[4]

Calgene concluded these stomach problems were unrelated to eating
genetically engineered tomatoes, but it had no explanation for
why they appeared. An FDA staff scientist who reviewed Calgene's
data said there were "doubts as to the validity of any scientific
conclusion(s) which may be drawn from the studies' findings,"
because Calgene could not explain the variations in results among
the three tests.[4] In spite of the doubts expressed by its own
staff, FDA categorized the Flavr Savr tomato as GRAS and approved
it for sale. (The Flavr Savr did not sell well, so it has
disappeared from stores.)[1, pgs. 83-84]

In January 2001, the FDA proposed new regulations on genetically
engineered food. These proposed regulations still fail to require
either pre-market safety testing or labeling of genetically
engineered foods.[5] FDA says "there does not appear to be any
new scientific information that raises questions about the safety
of bioengineered food currently being marketed," and states once
again that genetically engineered foods are "generally recognized
as safe."[6, pgs. 4708-9]

To make this claim, FDA had to ignore scientific information that
had been brought to its attention explicitly during the previous
year. In March 2000, the Center for Food Safety and partner
organizations filed a legal petition asking FDA to start
requiring pre-market safety testing, environmental impact
assessments, and labeling for all genetically engineered foods.
The petition included a thorough review of new scientific
evidence on safety concerns associated with genetic

The main new requirement in FDA's proposed regulations is that
producers of genetically engineered foods must notify FDA 120
days before bringing a new genetically engineered food to market.
This notification, known as a pre-market biotechnology notice
(PBN), would include various information, such as whether the
product contains antibiotic-resistance marker genes and whether
it is likely to produce allergic reactions. FDA says it will make
a list of PBNs available to the public, but the list may not be
complete. In some cases, FDA says, the existence of a PBN could
be considered "confidential commercial information."[6, pg.
4723] As a result, under the proposed regulations a company could
market a genetically engineered food without any public
notification. FDA's proposed regulations are open for public
comment until April 3, 2001.[5]

FDA has also proposed to create non-binding guidance for
voluntary labeling. This guidance is clearly not intended for
companies using genetically engineered crops, which have nothing
to gain by telling consumers what is in their food. Instead, the
guidance undermines consumers' right to know what they are buying
and threatens to limit the free speech of organic and other food
producers, by discouraging the use of labels with phrases such as
"biotech free" or "no genetically engineered materials." FDA says
these labels will be misleading on most foods, because ordinary
food could be contaminated with the products of genetic
engineering. In addition, FDA says these phrases could imply that
non-engineered food is superior to engineered food, which, FDA
says, would be misleading.[8, pg. 4840]

U.S. Department of Agriculture

Under the Federal Plant Pest Act, the U.S. Department of
Agriculture (USDA) is responsible for regulating "plant pests" --
organisms that could cause harm to a plant. USDA considers
genetically engineered plants to be possible plant pests if they
contain genetic material from organisms, such as some bacteria,
included on an official list of plant pests.[1, pg. 109] Plants
engineered without the use of genes from a recognized plant pest
may escape USDA regulation entirely. Even when genes from a plant
pest are involved, the manufacturer has discretion to decide
whether the engineered plant is itself a plant pest. USDA does
not tell manufacturers what data to take into account when they
make this decision.[1, pgs. 110-111]

Under USDA's rules, genetically engineered crops that are
considered plant pests must first be approved for field testing
before they are approved for commercial planting. After
conducting field tests, the developer of a genetically engineered
crop can apply for "nonregulated status," under which the crop
can be planted commercially with no further oversight from USDA.
USDA leaves it up to the developer to decide what data to submit
in support of its application for nonregulated status.[1, pg.
111] According to a recent article in AMERICAN SCIENTIST, many
tests that companies submit to USDA are poorly designed, so they
are unlikely to reveal any adverse effects that may occur.[9]

U.S. Environmental Protection Agency

As we saw in REHN #716, crops can be engineered to kill certain
insects by adding a gene derived from the bacterium BACILLUS
THURINGIENSIS (Bt). Under its authority to regulate pesticides,
the U.S. Environmental Protection Agency (EPA) is responsible for
evaluating the health and environmental consequences of these
engineered plants, which are, themselves, pesticidal.

EPA has registered pesticidal crops for five years, but the
agency makes these registration decisions on a case-by-case
basis; it does not have a standard testing system tailored to the
hazards posed by genetically engineered crops.[1, pg. 176] EPA
says it is reviewing existing registrations for Bt corn and
cotton this year, in order to decide whether it is safe to
continue growing them.[10]

When EPA registers a chemical pesticide for use on food crops, it
establishes a tolerance level -- an amount of pesticide residue
that is allowable on food. However, thus far EPA has exempted all
pesticidal crops from this requirement.[1, pg. 106]

Pesticidal crops are likely to promote the development of Bt-resistant
pest populations. (See REHN #637, #718.) Despite ample
scientific knowledge about this danger, EPA waited until December
1999 to issue requirements for resistance management. Under these
requirements, companies selling Bt corn are responsible for
making sure that farmers grow "refuges" of ordinary corn
alongside their pesticidal crops. The idea is that some pest
insects will eat only the ordinary corn, so they will be
sheltered from the evolutionary pressure that promotes the
development of resistant pest populations.[1, pgs. 106-7]

In the past five years, corporations have introduced a powerful
new technology into our food system without understanding the
basics of how this technology works. Government agencies have
refused to gather crucial data on how this technology can affect
ecosystems and human health. Once again, we are flying blind.


*Rachel Massey is a consultant to Environmental Research

[1] Thomas O. McGarity and Patricia I. Hansen, BREEDING DISTRUST:
Food Policy Institute of the Consumer Federation of America,
January 11, 2001. Available at

[2] U.S Food and Drug Administration (FDA), "Statement of Policy:
Food Derived from New Plant Varieties," FEDERAL REGISTER Vol. 57,
No. 104, May 29, 1992, pgs. 22984-23005. Available at

[3] Marion Burros, "Documents Show Officials Disagreed on Altered
Food," NEW YORK TIMES December 1, 1999. Available at

[4] Fred A. Hines, "FLAVR SAVR Tomato (Pathology Review PR-152;
FDA Number FMF-000526): Pathology Branch's Evaluation of Rats
with Stomach Lesions from Three Four-Week Oral (Gavage) Toxicity
Studies (IRDC Study Nos. 677-002, 677-004, and 677-005) and an
Expert Panel's Report." Memo to Linda Kahl, Biotechnology Policy
Branch, June 16, 1993. Available at

[5] See Joseph Mendelson, "The Food and Drug Administration's New
Proposal on Genetically Engineered Foods: First Draft Analysis,"
January 17, 2001. Available at
cam_id=70. Also see this web site for
information on writing to FDA about the proposed regulations.

[6] U.S. Food and Drug Administration (FDA), "Premarket Notice
Concerning Bioengineered Foods," FEDERAL REGISTER Vol. 66, No.
12, January 18, 2001, pgs. 4706-4738. Available at

[7] Center for Food Safety and others, "Citizen Petition Before
the United States Food and Drug Administration." Available at

[8] U.S. Food and Drug Administration (FDA), "Draft Guidance for
Industry: Voluntary Labeling Indicating Whether Foods Have or
Have Not Been Developed Using Bioengineering; Availability,"
FEDERAL REGISTER Vol. 66, No. 12, January 18, 2001, pgs.
4839-4842. Available at

[9] Michelle Marvier, "Ecology of Transgenic Crops," AMERICAN
SCIENTIST Vol. 89, No. 2 (March-April, 2001), pgs. 160-167.
Available at

[10] See Union of Concerned Scientists, "Bt Crop Renewals,"

Thanks to Charles Benbrook, Caroline Cox, Michael Hansen, Ellen
Hickey, Sheldon Krimsky, and Joseph Mendelson for reviewing
portions of this series.