The FDA issued a draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use, in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 (www.oaklandinstitute.org), works with the biosafety programme at Third World Network (TWN), an international NGO based in Malaysia.