THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
23 June 2003
Dear Friends and colleagues,
RE: SHORTCOMINGS OF US RULES ON GMOS
Below please find an article written by a former lawyer for the USDA during the Carter Administration which provides an overview of the workings of the regulatory system in the US with regards to agricultural biotechnology and how it is “failing to protect the public interest.”
The reason, says Claire Hope Cummings, is that it was designed that way.
Tracing back to the days when George Bush (senior) was the US Vice-president, GMO manufacturers were already lobbying in Washington, D.C. to ensure that the regulatory climate would favor their interests, leaving the manufacturers free of any real restraint. As a result, no new laws were passed governing biotechnology and federal agencies are still struggling to evaluate and approve a plethora of new and potentially dangerous products, using laws designed to deal with chemicals and pathogens, not genetics.
Another issue she raised which has vast implications for biosafety is the adoption of the principle of “substantial equivalence” behind the regulation of GMO food and agriculture. By failing to recognize that GMOs are unique and different from conventional crops by virtue of the process that they are created, the regulators have ignored the basis of some safety concerns and international biosafety protocols. [Note: The precautionary principle is the scientifically sound basis for biosafety regimes, and this is the basis for the national laws in a number of countries, and operationalised in the Cartagena Protocol on Biosafety which will enter into force on 11 September, 2002.]
We hope you will find the article enlightening as it sets the record straight that the US regulatory oversight, as it is currently designed and practised, has many shortcomings and should not be looked upon as a model for other countries.
With best wishes,
Lim Li Lin and Chee Yoke Heong
Third World Network
121-S Jalan Utama
Are GMOs being regulated or not?
(Source: Farm News from Cropchoice, USA, http://www.cropchoice.com)
(Wednesday, June 11, 2003 -- CropChoice guest commentary) -- New genetically modified organisms (GMOs) are on the loose and they are causing trouble. These are not the GMOs most people hear about: soybeans that resist weed killers or corn that kills insects. These are experimental crops that contain pharmaceutical proteins, industrial chemicals, even human genes.
They are being grown outdoors in hundreds of secret locations all over the country, in open-pollinated plants such as corn. This powerful new use of biotechnology is called “pharming,” and it poses very real threats to our personal and environmental health. Cases of pharm contamination have already occurred, raising new criticisms of the regulatory system in the United States.
When GMOs were first introduced into agriculture, farmers and consumer groups questioned the lack of basic protections. Since then, GMO contamination has spread from the corn fields in the Midwest to the birthplace of corn in the remote mountains of Mexico. Farmers have not been able to protect themselves from this genetic trespass. Instead of holding GMO manufacturers liable, the courts are upholding the patent rights of seed companies and making the farmers pay. Taxpayers are subsidizing the costs of GMO food recalls. While national polls show that well over 90% of U.S. consumers want GMO food labeled, government regulators still refuse to consider it.
By almost any measure, regulatory oversight of agricultural biotechnology is failing to protect the public interest. The reason is, it was designed that way. Long before there were any products ready for market, the GMO manufacturers were in Washington, D.C. taking pre-emptive action to ensure that the regulatory climate would favor their interests. The industry wanted to leave just enough regulation in place to give the public a sense of assurance, while leaving the manufacturers free of any real restraint.
In 1986, then Vice-President George Bush hosted Monsanto executives at the White House to discuss the “deregulation” of biotechnology. Then, after he became President, the framework that had been constructed during years of behind-the-scenes negotiations was announced by his Vice- President, Dan Quayle. Brushing aside the concerns voiced by independent scientists, farmers and consumer groups, Quayle said that “biotech products will receive the same oversight as other products” and not be “hampered by unnecessary regulation.”
The system that was created then is still in force today, with only a few minor exceptions. Basically, it was decided that there would be no new laws passed governing biotechnology. As a result, federal agencies are still struggling to evaluate and approve a plethora of new and potentially dangerous products, using laws designed to deal with chemicals and pathogens, not genetics. And they continue to be constrained by concepts developed with the best science available in the 1960s.
The reporting system is essentially voluntary and industry is trusted to inform the government of any problems that arise. It’s sort of a “don’t tell, don’t ask” arrangement. If industry does not tell government what it knows or suspects about its GMOs, the government does not ask. Once crops are released, there is no monitoring or follow-up. Agencies are free to ignore significant findings from independent sources, including reports about the nutritional deficits in food made from GMO crops, how genes wander when GMO crops cross with other plants, about recombinant viruses on the loose, and the growing problems of resistance and tolerance, to name just a few. As a result, evidence of emerging human health and ecological problems are routinely disregarded.
The federal government says that its processes are rigorous. It says that the lack of any reported human health problems associated with GMOs is evidence of its effectiveness. The biotech industry claims that their products are “the most studied” on the market. But the industry is simply referring to the studies they have done as they develop the product. They are not referring to any post-market evaluation. Underneath the government ‘s claims of safety lies a little known but fundamentally flawed idea that undermines the whole system.
The governing principle behind the regulation of GMO food and agriculture is a concept called “substantial equivalence.” It means that a GMO crop can be considered to be just the same as a conventional crop. Unfortunately there is no scientific justification for this idea. According to an article in the prestigious scientific journal Nature, the concept of substantial equivalence is “pseudo-scientific.” The article calls this idea a “commercial and political judgment masquerading as if it were scientific” and it was “created primarily to provide an excuse for not requiring biochemical or toxicological tests.” Legislators have never agreed on the meaning of substantial equivalence. This ambiguity, according to the article, “acts as a barrier to further research into the possible risks of eating GMOs.”
As applied, substantial equivalence means that regulators only look at a GMO product itself. They do not take the process used to manufacture it into consideration. This is a crucial mistake, because it is the process that makes GMOs unique. GMOs are organisms that can not be created using traditional breeding methods. The process is imprecise and unpredictable and more often than not, it results in failure. Getting a useful product out of that process depends on the use of viral vectors, anti-bacterial markers, promoters, switches and other genetically altered molecules to succeed. And it is these process-related molecules that should trouble us. They are the basis for some of the safety concerns of other countries and international biosafety protocols.
It is also revealing to take a look at how the three executive agencies that are primarily responsible for GMOs operate. The Food and Drug Administration (FDA), an agency of the Department of Health and Human Services, oversees GMO foods. The Environmental Protection Agency (EPA) deals with GMO pesticides. The Animal and Plant Health Inspection Service (APHIS), an agency of the United States Department of Agriculture (USDA), administers GMO plant testing in the field. All three operate only under their own legislation and none of their efforts are coordinated. The USDA relies on the Plant Pest Act, which narrowly defines plant pests and does not include all the processes or organisms currently used in genetic engineering. Permits for field tests are obtained from APHIS through a simple notification process, after which they are deregulated. There are only bare standards for biological containment of the field test and no provisions for evaluating certain ecological risks. APHIS can require an environmental assessment if the applicant indicates one might be required. A study of over 8,000 field test results submitted to the USDA showed that not one resulted in an environmental assessment.
The FDA uses the Food, Drug, and Cosmetic Act to review GMOs. The substantial equivalence doctrine fits nicely with FDA logic. It goes like this: any “novel” substances in food must be tested and perhaps labeled. However, if something can be “generally regarded as safe” (GRAS), as most conventional foods are, then they are exempt. Since GMOs are “substantially equivalent” to conventional food, they are considered GRAS and thus they do not require testing or labels. The EPA makes some effort to deal with the environmental impacts of GMOs. It regulates GMO pesticides (primarily the Bt crops) under the Federal Insecticide, Fungicide, and Rodenticide Act and the Toxic Substances Control Act. The EPA operates under the assumption that Bt is safe, even though GMO Bt has been shown to have detrimental impacts on soil micro-organisms and beneficial insect populations. The EPA recommendations and permit requirements, such as its Insect Resistance Management Plans for farmers, which are supposed to slow down the development of resistance to Bt, are not adequate to the task.
Here is an example of how this regulatory patchwork plays out in the field: In April 2003, the EPA announced that a company growing experimental GMO corn in Hawaii had finally satisfied the agency’s regulatory requirements. The company, Pioneer Hi-Bred, had been fined for permit violations in 2002 and was ordered to test and report its findings to the EPA to ensure that their experimental corn did not contaminate nearby fields. When the company failed to report on its testing, in direct violation of its agreement with EPA, it was fined again. Later, after acquiring and reviewing the test findings, the EPA said it was satisfied that the company was in compliance. But did that mean there was no contamination? No, there was. But it involved fields that were regulated by the USDA, so the EPA was not concerned about that. For their part, the USDA had no comment, saying it was investigating. Meanwhile, the company has asked neighboring farmers on the island not to plant any of the crops that Pioneer is using in its experiments, as a way of avoiding cross-contamination.
ABOUT THE AUTHOR
Claire Hope Cummings was a lawyer for the USDA during the Carter Administration. She has farmed in California and in Vietnam where she had an organic farm along the Mekong River. As a print and broadcast journalist, she covers the environmental and cultural costs of industrial agriculture and follows the progress of the sustainable agriculture movement. Her latest work on agricultural biotechnology “Risking Corn, Risking Culture” was published in World Watch Magazine in December, 2002, and she has written A Farmer’s Guide to GMOs for Farm Aid and The National Family Farm Coalition, and the Environmental Media Services Reporter’s and Editor’s Guide to Genetic Engineering in Agriculture. She is a 2001 Food and Society Policy Fellow.