Third World Network
BRIEFING PAPER #2
Contamination by experimental genetically engineered
crops should not be “found acceptable”
The US Food and Drug Administration recently issued its draft guidance for industry, for early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 There are concerns that the draft guidance,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 The FDA draft
guidance is part of a package of US proposals for the unintentional presence of experimental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 meets 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 will be 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 Comments were invited on this draft guidance by 24 January 2005.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draft guidance is available at http://www.cfsan.fda.gov/~dms/bioprgui.html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The FDA draft guidance was issued in response to a US Office of Science and Technology Policy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
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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 later
found 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 crosspollination 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.
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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 will not have been 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.
Third World Network, 121-S Jalan Utama, 10450 Penang, Malaysia.
Fax: +604-2264505 Email: twnet@po.jaring.my Web: www.twnside.org.sg
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