Applying The Precautionary Approach To Living Modified Organisms

Workshop Presented at the
Intergovernmental Committee For the Cartagena Protocol on Biosafety
December 11-15
Montpellier, France

REVISED September 2001

by:
Katherine Barrett, Ph.D.
Science and Environmental Health Network &
University of Victoria
kbarrett@uvic.ca

INTRODUCTION

The Cartagena Protocol on Biosafety is an outgrowth of the more comprehensive 1992 Conventional on Biological Diversity which called for specific procedures governing the “safe transfer, handling and use of any living modified organism (LMO) resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity” (CBD, Art. 19.3). After many years of negotiation among parties to the convention, the Cartagena Protocol on Biosafety was adopted in Montreal in January 2000. The Protocol focuses on the potential hazards of “transboundary” (international) movement of LMOs, and sets guidelines by which parties should evaluate potential hazards, and make decisions regarding importation and release of new LMOs.  

The Protocol contains direct reference to the precautionary approach (in the Preamble) and also includes precautionary language in the binding text. Articles 10 and 11 state that parties are permitted to take precautionary measures to avoid harm caused by LMOs, even when there is lack of scientific certainty regarding the extent of harm that might occur. The Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP) must now determine how the precautionary approach will be implemented in a non-arbitrary manner. Specifically, importing countries must have clear guidelines for applying a precautionary approach to particular LMOs. This paper outlines three core elements of the precautionary approach or ‘precautionary principle’, and suggests how precaution can applied be to the transboundary movement and release of LMOs.

Specifically, I address the questions:

1.  How is harm defined? What kinds of harm or “adverse effects” fall under the scope of the Protocol, and therefore what kinds of adverse effects can parties legitimately take precautionary measures to avoid?

2.  Given the uncertainties surrounding the effects of LMOs, what will count as sufficient evidence of harm (thereby permitting precautionary action) and what will count as sufficient evidence of safety (which would render precautionary action unnecessary or illegitimate)?

3.  What kinds of precautionary measures or actions are appropriate? What types of precautionary actions will be considered legitimate and will be tolerated by the international community under other multi-lateral agreements such as the World Trade Organisation?

APPLYING THE PRECAUTIONARY APPROACH TO LMOS:  POINTS TO CONSIDER

1.  Definitions of Harm
Recognition of potential harm is a necessary step in a precautionary approach. Here, we are dealing with hazards that have been identified, and for which we have some evidence. But what kinds of “adverse effects” should raise our concerns and warrant precautionary measures? How broadly or narrowly should harm be defined?

The following 3 points should be examined when defining the scope of harm under the Cartagena Protocol on Biosafety.

(i)  The nature of potential harm
Adding a new genetic sequence to an existing organism and releasing that modified organism into the environment can result in changes at many different levels and scales, all of which may have adverse effects on biological diversity. It is therefore important to consider effects at multiple spatial and temporal scales. For example, changes can manifest at the level of:
 individuals, e.g. by creating new proteins that may have toxic effects
 populations, e.g. by creating populations that are more invasive or persistent 
 ecosystems, e.g. by altering interactions with other living organisms and the non-living environment
 the interface of social and ecological systems, e.g. by changing agricultural practices or harming biological resources of cultural significance.

These effects cannot easily be separated because biological, ecological and social systems are interrelated and interdependent. Changes at one scale can bring about impacts at several other scales. Some effects (e.g. toxicity) are directly related to genetic changes while other effects (e.g. changes in pesticide use or agricultural practices) are indirect or downstream impacts.

Moreover, these impacts are distributed across time. They may be observed immediately and have only short-term effects (e.g. over a single generation), or they may manifest over the long-term or be persistent in the environment, lasting many years and generations. Effects may also be delayed. That is, there may be a lag time between releasing an LMO and observing its effects on the environment. This kind of delayed response is not uncommon in ecological systems.

In light of the above the points, it is important to recognise that our experience with LMOs to date has been limited. LMOs have been grown on commercial scales only in the last five or so years and most risk assessments are conducted during one or two field seasons. We therefore have little direct knowledge of long-term or delayed effects.

(ii)  The extent of potential harm
Several interpretations of the precautionary principle specify that preventative action should be taken when the threat of harm is ‘serious’. Often, however, we do not know how serious a particular threat might be. Do we take precautionary measures if there is any degree of potential hazard? We need some guidelines for evaluating the ‘seriousness’ of harms we are attempting to prevent. Such guidelines might consider hazards that are:
  not reversible, e.g. an irreparable loss of biodiversity or ecosystem function
  widespread, e.g. harms that extend beyond expected or intended boundaries
  accumulative, e.g.  if the effects of a particular LMO add to existing harms or contribute to future harms.

These are physical dimensions of harm that can be addressed to some extent through scientific study. However, there are also social dimensions of harm, those having to do with the way technologies are developed and introduced. For example, are potentially harmful technologies imposed upon the public or are they openly debated and negotiated? Who is most affected by potential adverse effects? Who stands to gain most? Risks and uncertainties that are imposed are likely to be experienced as more severe than those that are accepted voluntarily, as the current biotechnology debate has well demonstrated.

(iii)  Points of reference
Conclusions about the safety or risks of LMOs will depend on the standards against which such impacts are measured. For example, several regulatory policies measure the potential impacts of modified organisms relative to the impacts of large-scale, high-input agriculture. By this standard, LMOs are considered hazardous, only if they pose a greater threat than intensive agricultural practices. A different standard of comparison (e.g. organic or low-input agriculture) will likely result in different conclusions about the impacts of LMOs. Under the Protocol, such standards must be explicit, and must be sufficiently flexible to accommodate higher levels of environmental protection.

To summarise this section, it is critical to negotiate and make explicit the scope of “adverse impacts” encompassed by the Cartagena Protocol on Biosafety and the precautionary principle. This includes the nature and extent of hazards, as well as the standards we use to measure potential and existing harms.

2.  Recognition of Uncertainty
The second core element of the precautionary approach is recognition of uncertainty. Although there is a growing body of scientific evidence suggesting LMOs can cause adverse impacts on the environment and human health, this evidence remains uncertain and controversial.

How does uncertainty affect decision-making? The Protocol suggests that parties should err on the side of caution when there is lack of scientific certainty and until there is evidence to demonstrate adequate safety. Implementing these provisions will require analysis of the causes and extent of uncertainty, and careful evaluation of the evidence used to demonstrate safety.

Uncertainty persists in part because insufficient research has been conducted on ecological systems in general, and on the potential effects of LMOs in particular. In many respects our knowledge is in its infancy. What kinds of impacts constitute serious harm to biological diversity and ecosystem functions? What impacts are relatively safe?

Uncertainty also persists because we are dealing with highly complex, variable and interdependent systems that do not lend themselves to simple cause-and-effect explanations or isolated experimentation. In fact, complexity and irresolvable uncertainty are now recognised principles of ecosystems-based management which has been adopted as a cross-cutting approach to all issues under the Convention on Biological Diversity (and therefore under the Cartagena Protocol on Biosafety). This ‘great uncertainty’ is not simply a temporary lack of information but reflects a fundamental indeterminacy that will always confound models and decision-making. Failure to consider the extent of uncertainty ignores a key dimension of the problem and therefore may cause us to overlook potential hazards. Conservation biologists and natural resource managers are beginning to articulate and develop scientific processes that are appropriate to such conditions. Uncertainty does not make science irrelevant, but rather should lead to us a more robust and appropriate style of science. In accepting this challenge we should consider:

(i)  Error bias
Assessment of the environmental hazards of LMOs through laboratory studies and field trials is confounded by several factors. First, as mentioned above, we are dealing with several interrelated, complex and variable systems. Second, the impacts of LMOs may be unforeseen and unprecedented. Third, the incidence or frequency of adverse events may be low, although the consequences of these events may be extremely serious.

Under these conditions, detection and evaluation of adverse effects will require experiments and monitoring procedures designed specifically for the purpose. Tests designed for other purposes (such as evaluating agronomic traits) or poorly designed trials will likely show that LMOs have ‘no effect’.  If we don’t look, we won’t find. Such conclusions may indicate, or result in, a bias toward safety; a bias toward concluding LMOs pose no adverse effects when in fact they may. In these situations, we should look carefully at how the tests were designed. What was the sample size? What was the geographic range and time scale of the tests? What control or comparison studies were used? Careful attention to these questions will determine if tests are sensitive and robust enough to detect adverse effects, and therefore will help to shift error bias toward caution.

(ii)  Weight of evidence
When dealing with complex systems, experimental evidence gathered on a single isolated variable may be a poor indicator of how the system functions as a whole. While laboratory experiments and controlled field trials will tell us something about potential impacts of LMOs, we cannot expect these methods to predict accurately effects of unconfined, global release over long periods of time. Such limited methods might give us very precise answers, but to inappropriate or incomplete questions. We must therefore include as valid several other types evidence, and consider the ‘weight’ or ‘balance’ of this evidence when making decisions.

What kinds of evidence or information should be considered? I suggest we include:
  Multiple disciplines and cross-disciplinary investigation, e.g. including ecology, evolutionary biology, sociology, economics and ethics
  Local knowledge, e.g. traditional ecological and agricultural knowledge
  Case studies, e.g. documented experiences of people who have used the technology
  Correlation to other similar technologies or activities, e.g. release of non-indigenous plants
	
(iii)  Participation and transparency
Despite attempts to acknowledge and reduce uncertainty, conclusions about the potential effects of LMOs and decisions about their use will always involve an element of informed judgement. Such judgements will be better informed if all stages of the research and decision-making process are open and transparent. Participatory procedures are not only more democratic, but are also likely to yield more robust and appropriate evidence upon which to base decisions.

3.  Precautionary Action
The third core element of the precautionary approach is ‘precautionary action’, or the measures adopted once potential harm and scientific uncertainty are recognised. The Cartagena Protocol on Biosafety endorses the right of parties to make an “appropriate” decision to avoid or minimise the potential adverse effects of LMOs on biodiversity. Yet there are many forms of precautionary action. The most appropriate form should be a function of the level of identified harm, the extent of uncertainty, and the availability of alternative technologies. Examples of precautionary action include:

(i)  Bans on new LMOs or phasing out of existing LMOs
Bans and phase-outs may be appropriate if the stakes are high (e.g. if there is evidence that hazards are serious) and/or the level of uncertainty is high and/or alternatives are readily available. However, saying ‘no’ is not the only form of precautionary action.

(ii)  Moratoria on further development and commercialisation
Based on existing evidence and uncertainties, a temporary ban may be appropriate. This measure must include a commitment to continued research on the potential hazards and benefits of LMOs.  To be effective, this research should follow the guidelines discussed above. 

(iii)  Conditional approvals with monitoring
Conditional approvals may be warranted if well-designed, peer-reviewed testing and open decision-making procedures indicate low potential for adverse effects and a low degree of uncertainty. Conditions applied to the approval of LMOs may include restricted time-frames, restricted geographic ranges and/or restricted commercial uses. Such approvals must also be coupled to careful monitoring for adverse impacts, and effective mechanisms for labelling and tracing LMOs. This option, however, rests on the assumption that adverse effects can and will be detected through monitoring, and further, that once adverse effects are detected, they can be reversed or controlled. Proponents and decision-makers must acknowledge and take responsibility for the repercussions of such assumptions.

The above precautionary measures are case-specific and involve in-depth analysis and testing of specific LMOs. However some forms of precautionary action should apply to all decision-making regarding uncertain and potentially hazardous activities. The measures outlined below should encompass and precede more specific assessments and therefore must involve changes at the institutional level. In this sense, the precautionary principle is an overarching framework for decision-making that involves careful planning and foresight.

(iv)  Goal setting
What are our long-term goals for agriculture, the environment and public health? Does agricultural biotechnology contribute positively to these goals? In terms of the Cartagena Protocol on Biosafety, we should keep in mind the goals of the Convention on Biological Diversity:  conservation, sustainable use, and equitable sharing of biological diversity. A precautionary approach can help to achieve these goals, not by determining how much harm we can tolerate  an essential question of risk assessment  but rather by establishing policies for reducing and avoiding harm.

(v)  Alternatives assessment
What are the root problems that LMOs are developed to solve? Are there other, less uncertain and less hazardous ways to address these problems? In answering these questions we should consider a broad range of alternative technologies and carefully assess the potential harms and benefits of each option. In this way, a precautionary approach can stimulate development of innovative alternatives, rather than simply saying ‘no’ to a specific technology.

(vi)  Adaptive processes
Regulatory processes must be flexible and adaptive. They must implement mechanisms for information feedback to allow learning and support new research on potential effects of LMOs and on alternatives. This requires that institutions such as government and industry are not so committed economically or philosophically to agricultural biotechnology that precautionary measures become extremely costly to their investment. It requires that government and industry remain open to alternatives courses of action based on feedback from the scientific community and from the general public. Diversifying options and maintaining flexibility is simply an effective way to deal with uncertainty.

(vii)  Open decision-making
Finally, it is important to remember that the precautionary approach is not a strict, rule-based formula for decision-making. Rather, it is a principle or concept that guides our actions under conditions of uncertainty. It is also a principle that is very much alive and evolving. Implementing the precautionary principle will therefore require ongoing dialogue, and careful consideration of what we know, what we don’t know, where we are heading, and what we value. Open, inclusive discussion is crucial to addressing these issues.