Identify priority GE developments and solicit applications
Perform comparative assessment
Establish an independent review commission
Identify priority GE developments and solicit applications
The current approach is to let the market determine what GE products to develop and commercialize, but this has failed since most of the applications are not really for pressing problems. Instead, government should solicit applications for truly difficult problems that do not have a very viable alternative solution.
Such an approach was partially implemented by the federal government, although for different reasons, in the early 2000s for pest management. Provincial and federal governments realized that pesticide manufacturers would not develop products for pressing Canadian pest management challenges unless direction and supports were provided by government. Out of that realization, in combination with a new Pest Control Products Act, came a priority setting process that identified products more likely to receive expeditious treatment by regulators. A multistakeholder group identified priority products for registration on an annual basis (see Goal 4 Pesticides). Although the fundamentals of the approach have been compromised over time, it still provides a partial template for what is required for GE applications.
Applications would need to be conceptualized, developed and evaluated within an agoecological framework and focus on truly difficult problems with few apparent solution. This means having a multistakeholder group with agroecological expertise, which with changes to training (see Goal 3 Public research) should not be as difficult as it would be today. A challenge is that many of an organism's complex expressions that relate to challenging problems are controlled by multiple genes and gene-environment interactions, so current popular GE technologies are not so likely to be effective.
Some likely priorities include:
- industrial processes within contained environments to create useful inputs in agroecological systems (e.g. pheromones for pest management)
- Marker assisted plant breeding to help with priority breeding challenges
- Enhancing existing organism function (e.g., disease resistance)
Perform comparative assessment (adapted from CIELAP, 2002)
In a comparative assessment, a GE product is compared to other products, practices or systems to determine whether:
1. it presents significantly less risk to human health, wildlife or the environment;
2. it is relatively effective, also taking into account the risk of acquired product resistance;
3. it has relative economic or practical benefits for the user;
4. it provides broad social benefits that are well distributed.
There are four main outcomes from a comparative analysis:
The product is found to be superior, and is approved.
2. The product is found to be at least as good as other options and is approved with no impacts on other registered products.
3. The product is found to be useful in certain circumstances, requiring some limitations on its use.
4. The product is found to be unacceptable because it does not add anything to the existing toolbox of options.
This kind of assessment is already part of the U.S. and European pesticide regulatory systems. In Europe, some of this thinking has been incorporated into GE regulatory decision making. Broader societal assessments of benefit have been used to keep GE products such as recombinant Bovine Growth Hormone off the market on the grounds that the restructuring that would occur in the European dairy sector would have adverse affects on farmers. The Biosafety Protocol permits countries to use, as part of their process for reviewing trade in living GMOs, “socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities.”
A range of tools are available to do such assessments, including various iterations of Multi-criteria Decision Analysis which has been applied to questions of agricultural sustainability (cf. Talukder, 2016 for a review).
Establish an independent review commission
Because there are significant questions about conflict of interest within Canadian federal government units, given mandates to do both safety assessments and support the development of the biotechnology sector, it is important that safety assessments be transferred to independent review commissions with no economic development mandates.
in Germany, the Robert Koch Institute, the national public health institute with responsibilities to investigate all aspects of disease and health protection, is the designated competent authority under the Act on Genetic Engineering (see Redesign). They have responsibility for:
- human and animal health risk assessment
- deliberate release studies, and
- market approval evaluations for genetically modified organisms (novel foods and animal feed)
For the third area, they report to the Federal Office of Consumer Protection and Food Safety (BVL), the national regulatory authority. The institute is government - funded, autonomous and independent, and not dependent on industry research money.
Canada does not really have an organization comparable to the Robert Koch Institute, but an independent commission could be linked to the Royal Society which has already on a number of previous occasions provided assessments of GE safety and the regulatory process.
