Regulating a Brave New Genetically Modified World

Regulating a Brave New Genetically Modified World

by Donald K Anton

In the next 15 minutes I would like to examine the incipient international regulation of an increasingly genetically modified world under the new Cartegena Protocol on Biosafety -- ironically adopted, after 6 arduous years of negotiation, this past January in Montreal. Before looking at the Protocol, however, a few preliminary observations about the development and use of genetic engineering are in order.

The development and use of genetic engineering

Genetic engineering raises very considerable moral concerns and ethical dangers, as well as significant health and environmental risks. It also presents the potential for enormous benefits in the cure of disease and the production of food for the world`s starving and malnourished. As Arnold Toynbee prognosticated in 1966:

If biologists were to achieve the power to produce intended mutations of genes, that would mark a new departure in the operation of the process of evolution. For the first time, an existing species of living creature would be able to create new species on its own initiative, by a conscious and purposeful act of planning. This power to direct our own evolution, and the evolution of any other species, would have greater effects on mankind`s future than any power we have acquired so far.

Little more than 25 years later, humankind possessed this power. And, like every other power that we have acquired, it has found its way into use. In human gene therapy for example, genetic material produced in bacterial or non-human cells have been introduced into humans in the treatment disease in order to help the body modify the course of the disease. Echoing Toynbee, the Pittsburgh Human Gene Therapy Center claims that "gene therapy has become in effect the purposive genetic manipulation of the human organism".

These trangenic experiments are not limited to humans. In fact, much more frequent genetic manipulation has been visited on the non-human world. Since 1992, the genetic material of over 2000 different crops, livestock, fish, plants, insects, viruses, fungi, and bacteria has all been genetically altered in the lab in order to change some physical property or capability. One commentator has characterised this emerging alphabet soup of genes in the following vivid terms: "there are now fish genes in fruit, poultry genes in fish, animal genes in plants, growth hormones in milk, insect genes in vegetables, tree genes in grain, and in the case of pork, human genes in meat".

It is the international regulation of these genetically modified crops and related products, generally known as living modified organisms (LMOs), which the Cartegena Protocol on Biosafety attempts to address. Thus far, international regulation has not been brave enough to address human genetic manipulation.

The need for regulation

Before turning to the substance of the Protocol it is also important, I believe, to consider whether legal regulation of the field is necessary at all, since it has been called into question by not only those with vested interests, but also by apparently independent regulators. These detractors point out that since the earliest times, farmers have domesticated and bred plants and animals, selecting them and adapting them to their needs by exploiting and expanding genetic variability. Accordingly, some members of the biotechnology debate view the risks posed by LMOs as merely a conventional extension of traditional breeding. As the U.S. National Research Council has concluded, LMOs "should pose risks no different from those modified by classical genetic methods for similar traits".

This supposition, I believe, is false for two important reasons. First, it confuses the difference in the power between modern genetic engineering and conventional breeding. Conventional breeding must observe nature`s limits, both in terms of time and in terms of reproductive boundaries. Biotechnology and the ability to splice genes across biological barriers removes both of these limits of natrual breeding in radical fashion.

Second, the supposition confuses the distinction between the precision of biotechnology and predictability. There is no doubt that recombinant DNA techniques are more precise than classical methods for modifying genes. However, it does not follow that today`s scientists have the ability to predict the consequences of these techniques. Knowing precisely how genes have been modified in an organism does not provide a sound foundation for guessing the likely ecological effects of releasing that organism into the wild. Nor does this intellectual leap identify the particular types of risks about which we should be concerned.

The Biosafety Protocol

For these reasons, the regulation of LMOs and the risks they pose appears not only necessary, but also urgent. Internationally, last month the parties to the 1992 Convention on Biological Diversity adopted the Protocol on Biosafety in order establish a process for the safe transboundary transfer, handling and use of LMOs, and bioengineered products containing LMOs. The principal mechanisms established to achieve this objective are the advance informed agreement proceedure (AIA) between parties before export or import of LMOs and a risk assessment process to assist a State of import decide whether to allow the import.

Scope and coverage

At first blush, the scope of the Protocol seems extraordinarily comprehensive. Article 4 provides that, in principle, the Protocol applies to "the transboundary movement, transit, handling and use of all LMOs the may have adverse effects on the conservation and sustainable use of biological diversity", including risks to human health. It is notable that the scope is not limited to "significant" adverse effects, a qualifier found not only in the law of international responsibility for environmental harm, but also in many municipal EIA regimes. The mere prospect of an adverse effect appears to be sufficient to bring an LMO within the ambit of the Protocol.

A closer look at the Protocol, however, reveals that its scope is hedge by a large number of exceptions. Indeed, given the large amount of these exceptions, it is difficult to see how the Protocol will successfully meet its salutary objective. I will consider these problems after looking at practical workings of the Protocol under the AIA and risk assessment procedures.

Advanced informed Agreement (AIA)

As noted, the Cartagena Protocol establishes an AIA procedure as the primary mechanism to ensure what Article 1 calls "an adequate level of protection" for biological diversity from the transboundary movements of LMOs. What exactly an adequate level of protect consists of is uncertain, but it is certain that such an obligation will be subject to differing interpretations that mimic the sharp disputes between advocates of “all feasible protection” and “cost-benefit balancing” that surround the risk dilemma in municipal environmental law.

Now, under Article 7, before a Party of export can ship a LMO "for intentional introduction into the environment" of a Party of import, it must first notify the party of import setting out information about the LMO required by Annex I. As we shall see in more detail shortly, the use of the phrase “intentional introduction into the environment” eliminates the vast majority of LMOs from the notice requirement.

Moreover, Article 7.1 is expressly limits notice to the "first" transboundary movement. Accordingly, it appears that subsequent similar deliveries are to be free of regulation. However, under Article 10.3(a) the decision of a Party of import to approve the import of a LMO, may include conditions on how the decision will apply to subsequent imports of the same LMO. The effect of this provision may be to allow a Party of import to retain regulatory control by conditioning the approval to a specific delivery and requiring subsequent imports of the same LMO to comply with the Protocol`s AIA procedure.

For those LMOs covered by the notice provisions, a Party of import must acknowledge receipt of notification within 90 days. The State of import then has another 270 days to decide whether the import will be approved or prohibited. The Protocol makes clear, however, that a failure by a Party of import to abide by these time requirements does not imply its consent to the transboundary movement of the LMO into its territory.

Risk Assessment and socio-economic considerations

The decision to approve or prohibit import of an LMO must be based on a risk assessment carried out in accordance with Article 15 and Annex II of the Protocol. The assessment must be carried out in a "scientifically sound manner", but may be prepared by the producer and exporter of the LMO. While risk assessment must be scientifically rigorous, in making a decision to approve or prohibit the import of an LMO, the Party of import is entitled to apply a precautionary approach if the scientific knowledge about potential risks is unavailable or uncertain. Article 10.6 provides that

Lack of scientific certainty due to insufficient relevant scientific information . . . regarding the extent of the potential adverse effects of a LMO [on biological diversity], shall not prevent [the Party of import] from taking a decision [prohibiting import] . . . in order to avoid or minimise such potential adverse effects.

Moreover, under Article 26.1, in reaching a decision to allow or prohibit import, a party is entitled to consider socio-economic considerations arising from the potential impact of LMOs on biodiversity, especially as it relates to the value attached to it by indigenous and local communities.

In practice, the assessment of risks to biodiversity posed by LMOs under the Protocol is likely to replicate risk assessment at the national level. This is because the information required by the Protocol in connection with the assessment is largely what is required by municipal regulatory agencies such as the Australian and New Zealand Food Authority (and its U.S. counterpart, the Food and Drug Administration).

Unfortunately, as Professor Sheldon Kirmsky observes, these domestic risk assessment systems are woefully inadequate. What we have amounts to a voluntary system for assessing the risk of transgenic organisms. Companies that create LMOs regulate themselves by comparing their products against guidelines issued by municipal regulatory authorities. If businesses decide that their genetically modified products meet the guidelines, then they are free to produce, market, and sell their products without any significant governmental oversight. Regulators rely on industry data in granting approvals and there is no independent governmental testing of risk.

Exemptions and limitations

As indicated above, there are a number of exemptions and limitations that cut large holes in the coverage and effectiveness of the Protocol. The language of Article 4 itself reveals that the Protocol is not intended to cover the creation or development of LMOs in the first instance. That is left to the municipal law of states.

Moreover, Article 5 expressly excludes from coverage of the Protocol LMOs that are pharmaceuticals for humans.

Article 6 provides exemptions for LMOs in transit and in contained use. Article 6.1 exempts a Party of export from compliance with the AIA procedure and risk assessment in relation to states through which LMOs are only in transit. Article 6.2 of the Protocol exempts a Party of export from compliance with the AIA procedure and risk assessment in connection with LMOs destined for contained use in accordance with the standards of the Party of import. Of course, most developing states have no standards at all. In such a case it might be that the Protocol does not impose any obligations at all, other than the usual soft obligation on developed states to cooperate in capacity building. If the Party of import has no standards, the export must be permitted for contained use because no standard of the importing Party restricts or conditions it. On the other hand, one might argue that in the absence of standards, export destined for contained use is prohibited because, ipso facto, it cannot be "in accordance with the standards of the Party of import" because there are no standards to be in accordance with.

Article 11 establishes a separate procedure for the transboundary movement of commodities containing LMOs, including those intended for direct use as food or livestock feed, or for processing. No direct notice of export and import is required. However, a Party that allows such an LMO to be used domestically (except in field trials) must inform the Biosafety Clearing-House established by the Protocol and provide information about its genetic make-up and risks associated with its use. By using the Clearing-House, under Article 11, a Party can take a decsion regulating the import of LMO food and feed products that is consistent with the objective of the Protocol and based on scientific evidence of risk. Once again, in making the decision, the Party can apply the precautionary principle.

International trade rules

Now suppose that a State of import makes a decision to prohibit the import of an LMO under article 10 because it believes that the science is incomplete and uncertain about its potential long-term effects on the environment and that a precautionary approach dictates the need for more data before import can be allowed. The State of import believes that, at a minimum, the potential effects of the LMO should be studied in a closed microcosm replicating the exact conditions of the open environment where the LMO will be released over a number of generations in order to determine long-term effects, even though the Protocol is silent on this sort of risk assessment methodology. Suppose further that both the State of import and export are parties to the WTO/GATT and that the exporter claims that the decision represents a disguised barrier to trade in violation of the GATT. What happens?

Naturally I am going to say it is uncertain, especially since no direct conflict between a multilateral environmental agreement and trade rules has yet found its way before a WTO dispute settlement panel. However, the scenario raises a number of interesting issues.

Articles 2.4 and 26 of the Protocol are the only provisions that directly address its relationship with existing international trade agreements. Under article 2.4, the synergies between the Protocol and trade rules are only expressly addressed in the event that the state of import acts in a manner more protective of the environment than provided by the Protocol. It is silent as to the relationship if the state of import acts according to the Protocol. It provides that a Party may take action that is more protective of biodiversity than that required by the protocol, provided this heightened level of protection is “in accordance with its other obligations under international law”. This proviso is also contained in Article 26 entitling a party to consider socio-economic factors in deciding whether to let a LMO in to the country (a circumstance not relevant here).

Presumably these qualifications were included to ensure that the preexisting treaties, including trade agreements, would take priority in cases of conflict in accordance with the interpretive rule set out in Article 30.2 of the Vienna Convention on the Law of Treaties, although this result is by no means certain. Article 30.2 only applies to successive treaties relating to the same subject matter and arguments can be made both ways as to whether this is in fact the case.

Now, in the case supposed, the Party of export will likely argue that since the microcosm risk assessment methodology required by the State of import is not mentioned in the Protocol it constitutes heightened protection and because it does not comport with existing international trade law (ie it offends the GATT Articles III – because it arguably applies unequally to “like products” -- and Article XI – because it establishes an unrecognized import prohibition -- and because it does not fall within an Article XX environmental or health exception), it should not permitted under the protocol. On the other hand, the State of import will claim that the use of a microcosm is a scientifically “recognized risk assessment technique”, which Article 15 explicitly allows to be taken into account, and therefore, does not constitute heightened protection.

If we accept, for the moment, the State of import’s claim that it is acting within the scope of the Protocol, it still does little to settle the underlying question about the priority of norms in the case of a conflict with the GATT/WTO. The regime established by Protocol may get the benefit of the interpretive rule in Article 30.3 of the Vienna convention under which it could be argued that earlier trade treaties apply only to the extent that their provisions are compatible with those of the Protocol. Again, however, in order for this rule to apply the subject matter of the two treaties would have to be seen to be identical.

We might also turn to the Protocol’s Preamble -- a hortatory part of a treaty that may aid in interpretation, but in this case provides only circularity. The Preamble states:

· That trade and environment agreements should be mutually supportive with a view to achieving sustainable development;
· That the Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements, including trade agreements; and
· That the foregoing recital is not intended to subordinate the Protocol to other international agreements, including trade agreements.

This language seems to take us nowhere. Teleologically, we are told that the Protocol and trade agreements should be mutually supportive. Yet, we are provided no guidance where it is most necessary -- in cases of conflict. In the case of conflict we are merely told that trade agreements and the Protocol are normatively counterpoised with equal primacy. This leaves us little further than we currently are in determining how multilateral environmental agreements and trade agreements relate to each other. In my view, the resolution of this dilemma requires the WTO to adopt a set of environmental friendly interpretive rules and the reversal of at least one presumption under the Dispute Settlement understanding, all of which are beyond the scope of this presentation.

Conclusion

While the Biosafety Protocol represents a beginning of international regulation of genetic engineering, much still remains to be done. Areas of human genetic manipulation, LMO pharmaceuticals, the transit and contained use of LMOs, labeling (which time did not permit coverage of), the development of independent risk assessment, and reconciliation of international trade rules with multilateral environmental agreements are all areas in which work remains to be done.

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