How safe are transgenic crops?

Regulatory systems

Regulatory process for

transgenic crops in the U.S.

Institutional Biosafety Committee

Animal and Plant Health Inspection Service

(APHIS) of USDA

Food and Drug Administration (FDA)

Environmental Protection Agency (EPA)

International agreements

Institutional Biosafety
Committee (IBC)

Most research institutions have an IBC, which

monitors potentially hazardous biological
research and ensures compliance with NIH
safety procedures.

At CSU, for example, researchers must

receive IBC approval if planning to work with
recombinant DNA or other potentially
dangerous agents.

Institutional Biosafety
Committee (IBC)

Depending on the nature of the work, a

Biosafety Level is assigned. For transgenic
plants, the level would be BL1-P to BL4-P.

CSU's plant biotechnology greenhouse is a

BL2-P facility: restricted access, concrete
floor, screens to restrict small insects,
autoclave for all plant waste.

Animal and Plant Health

Inspection Service (APHIS)
To transport or field-test transgenic plants, there are
two procedures available:

1. Notification (for most common crops). A set of

criteria for the introduced gene must be met:
stable integration
non-pathogenic to animals or humans
unlikely to be toxic to non-target organisms
low risk of creating new plant viruses

2. If a transgenic plant does not meet the criteria

for "Notification", the developer must formally
apply for a permit to transport or grow the plant
in the environment.
Field testing requires procedures to minimize
spread of the transgene and keep it out of the
food supply. State or federal inspectors may
monitor.

Non-regulated status
To commercialize a transgenic plant, the
developer petitions APHIS for non-regulated
status. This requires extensive data on the
introduced gene construct, effects on plant
biology, and effects on the ecosystem,
including spread of the gene to other crops or
wild relatives.

Food and Drug

Administration
FDA staff consult with crop developers to
ensure that appropriate testing is conducted
by the developer.
FDA review may be required for transgenic
food crops if they involve
known toxicants
altered nutrient levels
new substances
allergenicity
antibiotic resistance markers

The FDA consultation

process for Roundup Ready
soybeans included data on

Molecular characterization of the transgene

In vitro and in vivo allergenicity tests
Compositional analysis of whole beans and
soy-derived products

Safety tests on rats, chickens, catfish, dairy

cattle, and bobwhite quail

Environmental
Protection Agency

Regulates the use of plants that produce

pesticidal substances.

Sets tolerance limits for pesticides in food, or

establishes an exemption from tolerance.

Establishes tolerances for herbicide residues

on herbicide-tolerant crops.

May require a resistance management plan

to slow development of resistance in the target
pest.

Regulatory quiz
Which federal agencies have jurisdiction over:

Viral resistance in a food crop?

Herbicide tolerance in a food crop?

Herbicide tolerance in an ornamental crop?
Modified oil content in a food crop?
Modified flower color in an ornamental crop?

Resistance management

EPA has mandated resistance management

strategies for Bt releases, based largely on
planting refuges of a non-Bt variety alongside
the Bt fields.

Resistant insects that survive in the Bt field will

mate with susceptible insects from the refuge.
Their offspring will be susceptible and will die if
they attack Bt crops.

Resistant (R) and susceptible (S)

European corn borer adults

BT corn

NonBT
corn

S
S

Potential problems with the refuge strategy

The frequency of Bt-resistant alleles in insect

populations may be greater than assumed in
models.

Bt-resistance may be dominant or semi-dominant

rather than recessive.

Resistant insects may mature earlier or later than

insects in refuge areas.

Only 71% of farmers followed rules in 2000.

Pink bollworm resistance

did not increase in Bt cotton

From 1997 to 1999 over half the cotton acreage

in Arizona has been planted to Bt varieties.

Bt-resistant alleles in pink bollworm were not

rare in 1997 (0.13 - 0.16). But contrary to
expectations, the frequency of resistant alleles
did not increase over the 2-year period.
Source: Tabashnik et al., 2000. Proc Natl. Acad. Sci. USA

The approval process for transgenic crops

in the US may be modified

In Jan. 2001, FDA

Proposed a requirement that it be informed at

least 120 days before GM products are marketed.

Announced voluntary guidelines for labeling

foods with and without GM ingredients.

USDA panel is conducting a 2-year review of

transgenic crop regulation.
National Academy of Sciences suggested changes
in an April 2000 report.

NAS report (April, 2000)

Genetically Modified Pest-Protected
Plants: Science and Regulation

No evidence that transgenic foods are unsafe.

Better methods of identifying potential allergens
should be developed.
Long-term studies should be initiated for effects
of GM crops on heath and the environment.
USDA, EPA, and FDA should more closely
coordinate their regulatory activities, and make
the process more open to the public.

Labeling of genetically engineered food:

current FDA policy

If a bioengineered food has a significantly

different nutritional property, its label must
reflect the difference.

If a new food includes an allergen that

consumers would not expect to be present,
the presence of that allergen must be
disclosed on the label.

Labeling of genetically engineered food

What constitutes a GE food product:
Which technologies included as GE?
1% of any ingredient?
Products of livestock fed transgenic feed?
Logistical difficulties of separating GE and
non-GE food

Testing not always informative

At what cost to consumers? One study
estimates 10% increase in food prices.

Proposed FDA policy for voluntary labeling

Genetically engineered

OK

This product contains cornmeal that

was produced using biotechnology.

OK

This product contains high oleic acid

soybean oil from soybeans
developed using biotechnology to
decrease the amount of saturated fat.

Underlined part
is mandatory.
Rest is
voluntary.

Proposed FDA policy for voluntary labeling

GMO free

Not genetically modified

No

We do not use ingredients

produced using biotechnology.

OK

This oil is made from soybeans that

were not genetically engineered.

OK

This cantaloupe was not genetically

engineered.

May be
misleading

International agreements
Codex Alimentarius (FAO / WHO): voluntary
standards for food safety testing of GM crops.
International Biosafety Protocol: Goal is to protect
biodiversity while regulating trade of GMOs.

Accepts precautionary principle, that a

country can reject GM products if there is a
lack of scientific certainty about the risks.

Provides aid to developing countries to

develop GM regulatory frameworks.

International agreements
World Trade Organization: Can impose
sanctions if a member country blocks import
of a product for non-science based reasons.
The WTO position on transgenic foods has not
been determined.

Evaluating the use of transgenic crops

Consider crops on a case-by-case basis, taking
into account

Nature of the introduced gene.

Plant parts and growth stage in which the

gene product is present.

Presence of related wild species in the

vicinity.

Evaluating the use of transgenic crops

Consider also the environmental effects of
alternatives to transgenic varieties:

Would more harmful chemicals be applied?

Would conservation tillage decrease?

What are the probability and effects of gene

escape from a non-transgenic variety?