Without a Trace
How a Lack of U.S. Domestic LMO Regulations is Undermining International Control
by Phil Bereano
The last provision of the Cartagena Biosafety Protocol was agreed to at 4:30 in the morning of January 29, 2000. This was Article 18-2(a), which covers the handling, transport, packaging and identification of living modified organisms (LMOs).
A conference of technical experts was held in Montreal in March 2005 to prepare implementing text for this provision for the full Meeting of the Parties to be held at the end of May. The topic is a contentious one, as it is directly related to industry shipping practices, government and public oversight, and consumer labeling, but a consensus must be reached as the 2-year deadline for refining how Article 18 is to be implemented is September 2005.
Several groups held a seminar or “teach-in” on aspects of implementing Article 18. The following is the argument I made at that event, concerning how the U.S.'s so-called regulations, especially the new FDA “guidance document” draft on pharma-crops, relate to the Protocol's provision on labeling and identifying these LMOs, suggesting that the laxity of these regulations presents a problem not only to U.S. citizens, but to the world at large.
INTRODUCTION
The United States is the world's largest grower and exporter of LMO crops. Thus, its domestic regulation of these crops can have ramifications for other nations. The U.S. government consistently argues that its regulations are based on “sound science,” and as such, these regulations guarantee the safety of exported LMOs. With the topic of handling, transport, packaging and identification of LMOs on the table, it is important to both explain and to critique these governmental rules.
Last fall, the FDA announced the drafting of a “Guidance Document” regarding early food safety evaluation of new proteins produced by LMO plants being tested for commercialization. The new generation of “pharma-crops,” which would produce drugs, industrial chemicals, or their components in a field instead of a lab, would fall under this document's purview. The Guidance Document itself does not have regulatory power over LMOs, but its contents make clear that it is meant to forestall stricter future regulations.
The FDA's Guidance Document proposes a so-called “safety assessment,” which is insufficient for identifying the problems with these crops. Under the safety assessment, a company may voluntarily conduct an evaluation and then consult with the FDA as to whether its experimental GE crop material is an “acceptable contaminant” for the food supply. Of course, because the safety assessment is voluntary, an LMO-producing company may decline to do any or all of the above.
This presents a serious conflict with Article 18 of the Cartagena Biosafety Protocol, which, as stated before, regulates the handling, transport, packaging and identification of LMOs. The Protocol's concerns for the traceability of these organisms must be defined within the legitimate objectives of a product tracing system. According to a 2004 U.S. Department of Agriculture document, these objectives are broad. They include industry goals of quality control, inventory management, and protecting goodwill through assuring consumer confidence. There are also consumer goals of insuring free choice and establishing liability for hazards. Finally, there are government objectives of monitoring to prevent fraud and to protect the environment, public safety, and public health, including providing a basis for instituting any necessary recalls. If monitoring the safety of LMOs is no more than a voluntary exercise on the part of the companies that produce them, it seems impossible that any of these objectives can be accomplished.
The FDA Commissioner, Lester Crawford, has described the Guidance Document's proposed policy as "a high priority for the Administration and the industry, to enhance public confidence, avoid product recalls, and provide an international model" for how to evaluate LMO foods. This ignores the fact that, two years ago, the Codex Alimentarius, the U.N. commission that oversees the quality and safety of food and nutritional supplements, adopted different guidelines for pre-market safety assessment of foods involving modern biotechnology. These guidelines are the international model, and, along with virtually every country in the world, the United States helped develop these procedures and voted to accept them.
The international procedures for risk assessment and safety assurance, as documented by the Codex and Biosafety Protocol, employ sound science. To date, the United States uses neither regulatory approach as a basis for overseeing LMO foods. This is despite its ostensible support for these procedures when they were created by international agreement.
SUBSTANTIAL EQUIVALENCE
Before tackling the specific issue of traceability of protein-producing LMOs, we must look at the bigger picture of how they are treated under existing U.S. regulations. In June 1992, the U.S. government announced that the FDA would not regulate food LMOs, as these foods were the “substantial equivalent” of non-engineered varieties. The announcement was made by Vice President Dan Quayle's “Council on Competitiveness,” a business group whose goal was to minimize governmental regulatory oversight, not to foster the protection of consumer health or environmental biodiversity.
The companies that produce such crops also patent them, however, and one of the requirements for a patent is that the product be “novel.” Clearly, an LMO cannot be both novel and the substantial equivalent of a pre-existing organism. Thus, although the U.S. claims it regulates the production and sale of these LMOs based on “sound science,” its reasoning is flawed. The concept of substantial equivalence is based on one of the central dogmas of genetics — that each gene codes for a single protein. This reductionistic paradigm, however, has by now been thoroughly discredited.
It seems that the concept of substantial equivalence was developed for the purpose of appearing to regulate LMOs without discomforting industry by any actual oversight. The United States may be the only country actually using the concept as the basis for its nominal regulations. The term has specifically been abandoned by the Codex. The Codex acknowledges that substantial equivalence may be useful as a starting point for a hazard analysis, but is not itself a measure or guarantee of safety.
The United States has, inconsistently, instituted new regulations on protection from bioterrorism, especially through the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. By requiring rigorous monitoring of imported foods, the new procedure is at variance with the position of the United States in negotiations at both the Codex Alimentarius and the Cartagena Biosafety Protocol. Considering that there has never been a documented case of bioterrorism involving food imported into the United States, the U.S. regulations in this regard are far more precautionary than the regulations to which it would subject its own LMO exports. The Act does not seem to measure up to the standard of “sound science” on which other U.S. food regulations are based, as it uses vague and subjective terms to describe what food products and problems it relates to, specifically, what is meant by “credible threats of serious adverse health consequences or death.” The text of the act can be found at http://www.cfsan.fda.gov/~dms/sec-ltr.html.
INTERNATIONAL IMPLICATIONS:
CONTAMINATION
While there has never been a bioterror attack involving food imported into the United States, contamination of its food supply by unapproved LMOs has occurred. In 2000, Kraft Foods recalled taco shells, which were discovered to contain StarLink, a strain of Bt corn developed by Aventis that was not approved for human consumption. More recently, Syngenta admitted to distributing an unapproved strain of Bt corn a well. (For more details on this incident, see “Syngenta Distributed Corn Unapproved for Human Use” on page 19). Future occurrences of this kind of contamination are inevitable, due to lax FDA oversight. These contaminations do not worry biotech companies; they are acceptable as part of a cynical industry strategy that the U.S. government is abetting. "In four years, enough GE crops will have been planted in South Africa that the pollen will have contaminated the entire continent," Emmy Simmons, assistant administrator of the U.S. Agency for International Development, told me in September 2002.
This approach to LMOs rejects the Precautionary Principle. It assumes them to be safe in absence of proof of danger, as opposed to considering them potentially risky unless proven safe. U.S. domestic law does not reject the principle on the whole, however, as statutes and regulations contain dozens of precautionary provisions, some even antedating their European equivalents by decades (as was the case with the FDA’s review of thalidomide). In the past 20 years, as the political balance in the United States shifted to favor industry over consumers, such an approach has been marginalized. This is not to say that the Precautionary Principle can no longer be implemented in the United States; it can be resuscitated when powerful interests so desire, as seen in the bioterrorism regulations.
LACK OF TRANSPARENCY
The lack of transparency in existing U.S. practices is also inconsistent with evolving international norms, as expressed both in the Codex and the Protocol. In a democracy, it is the public that needs to determine what is acceptable and what is not, but it is logically impossible to determine an “acceptable” level of contamination (as called for in the Guidance Document) when vital information is hidden from the public under the justification of protecting trade secrets.
Industry claims of protecting “confidential business information” have been routinely permitted and currently cover almost half of the genes being experimentally tested in U.S. fields. Consumer health and safety are thereby given secondary consideration, behind protecting intellectual property.
Besides putting public safety at risk, this policy also goes against public opinion. In a recent poll by the Pew Initiative for Food and Biotechnology, some 85 percent of U.S. consumers strongly believe that the government should assure the safety of genetically engineered foods before they are marketed. As with other food additives, the burden of proof for safety should be on the industry proponents, not on the regulators or hapless consumers. Having the FDA protect confidential business information prevents oversight and accountability.
CONCLUSION
Many of the LMOs that move across national boundaries are produced in the United States, under the flawed theory of “substantial equivalence,” lax oversight by the FDA, and total lack of transparency. The failure of U.S. administrations to properly oversee this new technology and to establish reasonable and trustworthy risk assessment processes means that Parties to the Protocol must rely on a strong implementation of Article 18 in order to help assure protection for biodiversity and human health within their borders.
Philip L. Bereano, JD, is Professor of Engineering (technology and public policy) at the University of Washington. He is the former Director of the University’s Program in Social Management of Technology. Portions of this article were taken from his talk at the March 16, 2005 Open-Ended Technical Expert Group on Identification Requirements of Living Modified Organisms Intended for Direct Use as Food or Feed, or for Processing.
