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[SANET-MG] Experimental GM food crop pollution should not be found acceptable



http://www.oaklandinstitute.org/?q=printpage&nid=162Contamination by
Experimental Genetically Engineered Crops Should Not be “Found
Acceptable” ap-ril 6,2005
The US Food and Drug Administration recently issued its draft guidance
for industry, for early food safety evaluation of new non-pesticidal
proteins produced by experimental bioengineered or genetically
engineered plants intended for food use.

There are concerns that the draft guidance, instead of assuring genuine
food safety evaluation, will instead permit contamination of food
supplies with inadequately tested experimental genetically engineered
proteins. The FDA draft guidance is part of a package of US proposals
for the unintentional presence of experimental genetically engineered
material to be “found acceptable."

By Lim Li Ching

The Open-Ended Technical Expert Group on Identification Requirements of
Living Modified Organisms Intended for Direct Use as Food or Feed, or
for Processing met in Montreal from 16-18 March 2005. This is a group
set up under the Cartagena Protocol on Biosafety. Issues related to the
unintentional presence of genetically engineered material in food were
pertinent to the discussions.

As such, it is worth taking a closer look at the 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.” This was issued by the Food and Drug Administration (FDA) of
the United States in November 2004. Comments were invited on this draft
guidance by 24 January 2005. The draft guidance is available at
http://www.cfsan.fda.gov/~dms/bioprgui.html

US Moves for Contamination to be “Found Acceptable”

The FDA draft guidance was issued in response to a US Office of Science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
(http://www.ostp.gov/html/redregbio.html).

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, focussed 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, works with the
biosafety programme at Third World Network (TWN), an international NGO
based in Malaysia. TWN is involved in efforts to bring about a greater
articulation of the needs and rights of peoples in developing countries;
a fair distribution of world resources; and forms of development which
are ecologically sustainable and fulfill human needs.

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