Franken Foods: Contamination by Experimental GM Crops Should Not be 'Found Accep

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Subject:GMW: Contamination by Experimental GM Crops Should Not be

'Found Acceptable'

" GM WATCH " <info

 

 

Thu, 7 Apr 2005 10:25:56 +0100

 

 

 

 

GM WATCH daily

http://www.gmwatch.org

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The current Syngenta rogue corn fiasco throws new light on US plans to

routinely allow unapproved genetically engineered proteins to

contaminate US food crops and hence exports.

 

As Lim Li Ching notes in the article below, " Short of FDA specifically

notifying importing countries of the presence of unapproved genetically

engineered proteins in US food exports and providing the necessary

reference materials to facilitate detection and identification, the only

way other countries can determine if there is presence of unapproved

genetically engineered material is to randomly test for their presence. "

 

But even countries as rich and technologically advanced as Japan and

the EU are currently claiming not to be able to, in the words of the

Japanese government, " start testing samples of corn cargoes from the

United

States " until they have " obtained the necessary data from Syngenta to

detect Bt10 [the unapproved maize]. "

http://www.gmwatch.org/archive2.asp?arcid=5073

 

Syngenta's foot-dragging suggests that the industry will do everything

it can not to facilitate that process.

 

The US is taking the world along a trajectory where the food supply may

not only be be modified at a molecular level in any number of ways but

where it has moved beyond all meaningful regulatory control.

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Contamination by Experimental Genetically Engineered Crops Should Not

be 'Found Acceptable'

by Lim Li Ching

Wednesday, March 23, 2005

http://www.commondreams.org/views05/0323-34.htm

 

The FDA issued a draft Guidance for Industry: Recommendations for the

Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by

New Plant Varieties Intended for Food Use, in November 2004. This was

issued in response to a US Office of Science and Technology Policy

(OSTP) notice published in the Federal Register of August 2, 2002. The

OSTP

proposed federal actions to update field test requirements and to

establish early food safety evaluation for new proteins produced by

genetically engineered plants.

 

One of the principles the US government relies on in the OSTP document

states: " Even if a trait or protein does not present an unacceptable

risk to the environment or public health, field test requirements should

still minimize the occurrence of out-crossing and commingling of seed

from these field tests, but intermittent, low levels of

biotechnology-derived genes and gene products from such field tests

could be found

acceptable based on data and information indicating the newly introduced

traits and proteins meet the applicable regulatory standards. " (emphasis

added)

 

The OSTP instructed the US Department of Agriculture (USDA), the FDA

and the Environmental Protection Agency (EPA) to develop procedures to

address this issue. The USDA took the first step toward implementing the

OSTP's directive in January 2004. Among other things, it sought public

comment as to whether " adventitious presence " (intermittent and

low-level presence) of genetically engineered plant material that has not

completed the required regulatory processes, in commercial crops, food,

feed, or seed, should be exempt from regulation and if so, under what

conditions.

 

The EPA regulates plant-incorporated protectants (PIPs) - the

pesticidal substances and genetic material necessary to produce the

substance,

when produced and used in living plants (e.g. Bt toxins and Bt genes in

Bt crops). The OSTP provided some proposals on how EPA should deal with

contamination by PIPs. In particular, the EPA would encourage

developers to seek approval for residues of PIPs in food very early in

the

research and development process, if there is a likelihood of

contamination

through gene flow. The EPA would have to issue a rule permitting the

residues of the PIP to be present in food. Such rules typically would

last " only as long as necessary to allow any food that might contain

residues to pass through the food distribution chain " .

 

How will experimental genetically engineered proteins in the food

supply be " found acceptable? " It would appear that the OSTP recommends a

process for food safety evaluation of experimental genetically engineered

proteins early in the research and development stage, so that if these

are found later to be in the food supply, there would be safety

assurances. But can we rely on the US early food safety evaluation

process?

 

Voluntary Early Food Safety Evaluation Inadequate

 

The stated purpose of the FDA's draft guidance is to set up a voluntary

mechanism for " early food safety evaluation " of new non-pesticidal

proteins from experimental genetically engineered plants intended for

food

use, which are being field-tested. This is to address the likelihood

that cross-pollination and commingling of seeds will occur, resulting in

the " inadvertent, intermittent, low-level presence in the food supply

of proteins that have not been evaluated through FDA's voluntary

consultation procedures for foods derived from new plant varieties " .

 

While the FDA has recognized the need to address the unintentional

presence of untested or insufficiently tested proteins in the food

chain -

a phenomenon commonly known as " contamination " - the proposed early

food safety evaluation is inadequate for genuine food safety evaluation.

The proposed process is non-mandatory, and fully reliant on companies

and developers to voluntarily provide a synopsis of safety data and

information about the new protein, focused mainly on toxicity and

allergenicity.

 

The concern over toxicity and allergenicity is welcome, but both the

scope and substance of the proposed data and information that should be

provided are limited. There is no specific mention of the need to assess

changes in nutritional composition, nor for comprehensive animal

feeding trials or tests for unintended effects caused by genetic

engineering.

The FDA assumes that if a protein introduced in one plant species

raises no safety concerns, this implies that the introduction of that

same

protein in another species is likewise " safe, " thereby ignoring

potential problems related to unintended insertion events (e.g., gene

silencing). Yet, unintended effects are an acknowledged risk factor by

the Codex

Alimentarius Commission, the joint agency of the World Health

Organization and the UN Food and Agriculture Organization, responsible

for the

international regulation of food safety.

 

Instead of a voluntary process, a mandatory, science-based and rigorous

review process designed to ensure food safety is needed. Such safety

assessments should be long term, inter-generational and on the whole

food, not just on the new substance that the genetically engineered plant

produces.

 

The FDA draft guidance in effect encourages a tacit acceptance of

contamination events, and in doing so, may further create a

disincentive to

control and/or avoid contamination. What are actually needed are strict

rules and procedures to prevent contamination of the food supply with

genetically engineered proteins.

 

How Will Importing Countries Deal With Experimental Genetically

Engineered Proteins?

 

Given the concerns about the inadequacies of the early food safety

evaluation as currently described in the FDA draft guidance,

confidence in

the process is not justified. However, if the new proteins are deemed

by the FDA to not raise food safety concerns, this effectively permits

contamination of the US food supply with experimental and inadequately

tested genetically engineered proteins.

 

Countries that import food from the US could also be affected, due to

contamination of their food imports with experimental and inadequately

tested genetically engineered proteins. This contamination would not be

addressed by the US regulatory laws, as the early food safety

evaluation would have deemed this contamination " acceptable. "

 

It is unclear how the FDA, with this draft guidance, intends to comply

with other countries' domestic regulations for unapproved or

unauthorized genetically engineered organisms. The European Union, for

example,

has zero tolerance for unapproved genetically engineered organisms. Will

the contamination of US food supplies with experimental and

inadequately tested genetically engineered proteins compromise other

countries'

efforts to ensure zero tolerance for such proteins, which may be

unapproved in their country, in the food supply?

 

As most developing countries lack the regulations, capacity and means

to enforce biosafety legislation or bans, the reality remains that

unapproved genetically engineered food may slip through.

 

Short of FDA specifically notifying importing countries of the presence

of unapproved genetically engineered proteins in US food exports and

providing the necessary reference materials to facilitate detection and

identification, the only way other countries can determine if there is

presence of unapproved genetically engineered material is to randomly

test for their presence. However, this shifts the burden and cost of

testing and monitoring on the recipient countries and still does not

provide a guarantee of detection and identification.

 

The FDA reportedly intends to use this draft guidance as an

international model to address the presence of low levels of genetically

engineered plant material in non-genetically engineered crop fields.

Will there

also be similar proposals for contamination from genetically engineered

crops producing pharmaceuticals and industrial compounds to be " found

acceptable? "

 

Meanwhile, 116 countries have ratified the Cartagena Protocol on

Biosafety. The Protocol specifically reaffirms the right of importing

countries to reject or place conditions on the import of genetically

engineered organisms intended for food or feed, and to formulate their

own

biosafety legislation, which can be crafted to keep them GE-free. Thus

there

should be careful scrutiny of the US proposals that may find their way

into global negotiations or unilaterally affect importing countries.

 

Lim Li Ching, Senior Fellow at The Oakland Institute

(http://www.oaklandinstitute.org ), works with the biosafety programme

at Third World Network (TWN), an international NGO based in Malaysia.

 

 

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