Molecular Biotechnology: Principles and Applications - Glick, B., & Pasternak, J. 2002

Regulation of Molecular Biotechnology Research and Patenting of Biotechnological Inventions
Regulation of the Application of Biotechnological Methods
Controlled Release of Genetically Modified Organisms into the Environment

By 1982, it became clear that it was necessary to develop guidelines for conducting open-field testing of genetically engineered organisms in order to properly monitor their release into the environment. However, neither rules nor protocols had been established to guide creators of such organisms on what specific information needed to be included in Applications for authorization of such tests. This sluggishness was driven by the prevailing view among molecular biologists that genetically engineered organisms differed very little from their unmodified predecessors, and that any existing differences could easily be detected through appropriate biological tests.

In 1982, the NIH-RAC received three applications for field trials of GMOs. Two of them involved genetically modified plants (corn and tobacco), while the third concerned testing a genetically modified strain of the microorganism Pseudomonas syringae to determine whether such a strain could reduce frost damage in plants. This precedent became a turning point in The regulation of Procedures designed to control the release of GMOs into the environment.

Ice-minus Pseudomonas syringae

The genetic modification of P. syringae involved, in particular, the deletion of the Gene encoding the protein responsible for ice crystal formation. The testing was designed to determine whether spraying the modified strain onto plant leaves could prevent frost damage. Wild-type P. syringae, which normally inhabits leaves, secretes a protein that triggers ice crystal formation at low temperatures, leading to plant damage. The protection strategy consisted of applying modified Bacteria to the leaves prior to their colonization by wild-type bacteria. This measure promised significant economic benefits; for instance, annual frost damage in the U.S. is estimated at $1 billion.

Upon receiving applications for GMO field trials, the NIH-RAC undertook actions similar to those used for recombinant DNA experiments, namely:

1. The applications were published in the Federal Register.

2. Information regarding them was distributed to 3,000 interested parties.

3. The proposals were reviewed by a panel of experts.

4. Each proposal was discussed in open hearings.

5. Concurrently, the applications were reviewed by the NIC-RAC itself, as well as by the U.S. Department of Agriculture.

Following a thorough analysis, the Department and the NIH-RAC issued a positive decision on the application to test the P. syringae strain with the deleted ice-nucleation protein gene, and in 1983 the NIH Director formally approved this decision. However, on the very day the field trial permit was issued, a lawsuit was filed to block the tests. It was brought by an Organization called the Foundation on Economic Research, headed by Jeremy Rifkin, which was in outright opposition to all Introduction/32.html">Genetic Engineering experiments. The lawsuit was granted, with the ruling stating that the NIH-RAC had failed to conduct proper hearings in accordance with U.S. law and, more importantly, had not requested data on the environmental safety of the modified organisms.

This legal decision clearly demonstrated that, despite the scientifically sound opinion of the NIH-RAC and the Conclusions of its experts, the existing regulations governing GMO field trials were inadequate. Outside the NIH-RAC, the prevailing view was that the Introduction of a genetically engineered Organism into the environment could have long-term consequences, as living microorganisms reproduce, persist, and spread in the environment, and sometimes transfer their Genetic information to other microorganisms. Some critics of GMO release regulatory programs argued that genetically modified organisms would outcompete existing species from their ecological niches, leading to severe adverse environmental changes. Additionally, concerns were raised that genes could be transferred from GMOs to natural strains, potentially giving rise (albeit unintentionally) to ecologically hazardous organisms. Of course, all these arguments represented worst-case and highly improbable scenarios of environmental impact from GMOs; nevertheless, it was evident that the regulations governing GMO field trials needed to provide for a rigorous assessment of potential risks.

Currently, the Environmental Protection Agency (EPA) and the Department of Agriculture are responsible for evaluating applications involving the controlled release of GMOs into the environment in the U.S. The National Institutes of Health merely developed a set of criteria for GMO field trials and subsequently transferred its authority in this area to other organizations.

The EPA decided to use the two applications concerning ice-minus bacteria as a standard for developing regulations governing field trials for all GMOs. Each proposal underwent a critical review, which included evaluating the tests for environmental safety, ecological consequences, and potential impacts on human health, alongside a detailed examination of the GMO itself. The following organizations participated in the process:

✵ The Pesticide Programs Evaluation Division of the EPA.

✵ The Toxic Substances Research Planning Committee and the EPA Expert Committee.

✵ The EPA Administrative Council.

✵ The Department of Agriculture, FDA, and NIH.

✵ A Scientific Advisory Board consisting of microbiologists, plant pathologists, and general ecologists.

✵ Various state agencies, including the California Department of Food and Agriculture.

In addition, open public hearings were required.

It was inconceivable that such a complex, time-consuming, and often seemingly redundant Procedure could become a routine part of approving GMO field trials. Suggestions were made that as experience accumulated, this approach would be streamlined without losing effectiveness in assessing potential environmental harm. Following a highly complex analytical procedure, permits for the field testing of the ice-nucleation-deficient bacteria were finally granted for each application. However, in both instances, despite differing test conditions, local residents concerned about the release of GMOs in close proximity to their homes managed to obtain court injunctions temporarily halting the trials. Meanwhile, the EPA and the Department of Agriculture developed more sophisticated methodologies for assessing the risks of GMO introduction into the environment. Furthermore, during this brief period, the staff of these agencies enhanced their expertise in Processing and analyzing data submitted in field trial applications. Through the efforts of scientists, including ecologists, research programs were launched to evaluate the consequences of GMO release into the environment using model systems, and scientific organizations formulated baseline principles to determine whether a given GMO exerts adverse environmental side effects.

Ultimately, in 1987, field tests of these bacteria were conducted at specifically selected sites in California. The results showed that these bacteria did not spread beyond the test plots and did not persist in the area. At one of the sites, ice formation on plants occurred at a Temperature 1 °C lower than usual. Today, "antifreeze" bacteria are practically never used to protect agricultural crops from frost damage.

Open-field trials of other genetically modified organisms

Since the initial testing of the bacteria discussed above, numerous open-field trials of other GMOs have been conducted. They have shown that, as a rule, released GMOs do not spread beyond the test site, do not persist, do not transfer their genes to native microorganisms, and exhibit similar biological activity under both laboratory and natural conditions. Because each GMO may present distinct side effects, final decisions regarding field trials were made on a case-by-case basis. Such trials have been conducted in the USA, Great Britain, Australia, and other countries. However, biotechnology companies have been reluctant to develop genetically modified microorganisms intended for environmental use because the cost of field trials is extremely high, with no guarantee of a successful outcome even if the trials themselves go well. Nevertheless, it is fair to say that There is a growing consensus that the environmental release of laboratory- and field-tested genetically modified microorganisms will not result in adverse ecological consequences.

As for field trials of genetically modified animals, experts are extremely cautious. For instance, to assess the ability of certain Transgenic Fish to survive in the wild, a remarkably sophisticated aquarium was built in the United States to replicate natural conditions while guaranteeing complete Isolation of the fish and preventing poaching. In contrast, testing of transgenic food plants with improved traits was handled much less strictly. The prevailing view was that most such plants did not differ from conventional varieties produced through selective breeding. In the US, all genetically modified plants—regardless of the modification method—must undergo field trials and all testing procedures required to obtain a commercial license. At the same time, additional requirements are imposed on field trials of Transgenic Plants containing insecticide genes or genes providing resistance to viral infections.

In the US, transgenic plants carrying the toxin gene from Bacillus thuringiensis, including corn, soybeans, potatoes, and cotton, have been approved for use by all regulatory authorities. Conversely, attempts to introduce such crops in the Philippines were blocked by an international coalition of non-governmental organizations, while France banned the cultivation (though not the consumption) of transgenic B.t. corn. A great many people, for various reasons—ranging from unpredictable consequences to socio-ethical and economic concerns—remain distrustful of all GMOs.

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Implementing legislation to regulate the release of GMOs into the environment is a challenging task, and only a few countries have accomplished it. As discussed earlier, it is essential to guarantee the safety of GMO applications for both humans and the environment—in both the short and long term—without stifling beneficial developments. As the ancient Greek lawmaker Solon, who lived in 638–559 BC, once observed: "Laws are like spider webs: small insects are caught in them, while the big ones break through." When it comes to the controlled release of GMOs into the environment, no government wants the "big catch" to slip away.