Surveillance, the ongoing post-release observation of the organism to monitor its survival and dispersal or its environmental impact, is a form of monitoring appropriate when predetermined sampling regimes are impractical. However, devising a meaningful surveillance program presents difficulties when the environmental effects of a GMO release are only speculative. Furthermore, the large distances (e.g., kilometers) and long time intervals (e.g., years) associated with monitoring, for example, wind-driven pollen or seed dispersal may pres-

ent technical difficulties in the design of sampling regimes. Large-scale surveillance may demand large numbers of people or large numbers of sampling sites and is likely to challenge even the most ample budget. Unfortunately, these factors may influence responsible investigators to suggest monitoring schemes based more on the availability of resources than on the collection of scientifically valid data that addresses a biosafety question.

When the United States Environmental Protection Agency granted a permit for the sale of insect-resistant Bt cotton, the agency required implementation of surveillance programs to monitor for the occurrence of increased insect pest resistance to the endotoxin of Bacillus thuringiensis. Upon evaluating the methods employed initially, the agency subsequently called for the use of more sensitive methods to increase the probability of early detection should resistance to Bt emerge in the pest population.11

Practical Planning

Monitoring procedures may vary from qualitative to quantitative, from simple to complex. We present a representative basic approach to designing a monitoring plan in Figure 5. The first step in

Define objectives based on: step 1 Organism + Environment

+ Release Conditions


Determine appropriate monitoring intensity

Intensity factors

Design a monitoring plan


Environmental release


Evaluate monitoring program p^W^rkf? CO Modify monitoring program

Document results, apply to subsequent releases

Continue activity

Figure 5. A basic approach to designing a monitoring program. The flow diagram depicts the process of designing and conducting a monitoring program.

• Too much or too little effort given

• Unclear what to look for

• No appropriate mitigation available

planning a design is to define clearly the objectives of the monitoring plan, taking into consideration available knowledge of the organism to be released, the environment, conditions of the release (e.g., limited geographic area vs. open-market sales), potential risks as determined in a risk assessment, and regulatory requirements. The objectives of the monitoring plan determine the measurement endpoints. Integration of this information provides the basis for development of a specific monitoring plan.

The second step in a monitoring plan is to determine the appropriate level of intensity. Monitoring intensity is determined by the degree of uncertainty and the potential severity or probability of unwanted environmental impacts. The third step is to design the monitoring plan so that it includes specific sampling regimes and testing procedures. Step four is to evaluate the effectiveness of the plan after it is implemented. Thus it is important that monitoring plans be dynamic so that modifications can be made in response to changing conditions or unanticipated problems that might develop during the course of the program.

Biosafety assessors have an obligation to anticipate and avoid potential pitfalls in any monitoring design.

Ideally, a diverse collection of professionals will be involved in decisions about planning a monitoring program. These may include scientists conducting the research and development work, industry representatives concerned about financial soundness, legislators tracking constituency concerns, and regulators who claim jurisdiction. When working across professional boundaries, a risk assessor must learn to get results from diverse groups, which often requires finding a way to ask the question correctly and ensure that the right (trained) people are involved in the monitoring efforts. Cooperation (dialogue) among those involved is best begun even before applications are made and continued through data acquisition and analysis. The intent is not only to establish clear objectives, but also to ensure precise communication.

The risk assessor helps to ensure that adequate attention is paid to monitoring design and implementation. He or she needs to understand the monitoring objective and have some assurance that it is obtainable by implementing the monitoring design. If monitoring is intended as an environmental early-warning mechanism, there must be sufficient sensitivity to ensure the "alarm" is sounded in time to actually do something. A strategy must be in place for remediating an unwanted or unacceptable environmental impact, or, put more directly, there needs to be a plan describing what will be done should a crop be found going astray. It is equally important to distinguish between what is "nice to know" from what is "necessary to know." Monitoring programs not justified on the basis of risk simply waste resources, including the time of scientists and regulatory officials who will be obligated to review the irrelevant data collected.

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