- Effort should be invested in making transgenic animals safer from the outset,
e.g. by wise selection of breeding goals and improved expression vector design.
There is a need to develop improved vector/transformation systems (e.g. homologous
recombination and insulated insertions) that reduce the random nature of gene
insertion and, therefore, may decrease unintended effects. The Consultation
recommended avoiding the use of unnecessary DNA sequences in the genetic construct,
including marker genes.
- It is recommended that the approach for the molecular characterization
should be further standardized to include the flanking regions.
- The establishment of databases on the natural variation in key compositional
constituents in animal products, including fish products, will be an important
item in order to be able to assess unintended effects of the genetic modification.
- The Consultation agreed that the strategies and methodologies for the allergenicity
testing in GM animals will not differ fundamentally from those currently in
use for the assessment of GM plants. It was recognized that animal models
for allergenicity testing, even those that are not yet validated, may be of
value to identify potential allergens. It is recommended that additional efforts
should be directed to the further development and validation of these models.
More research efforts should be devoted to the elucidation of mechanisms of
allergenicity.
- There is a need to improve the accessibility and interconnectivity of existing
databases or to establish a centralized database on allergenic linear and
conformational epitopes and tools for screening transgenes for allergenic
potential.
- There is a clear need to continue the development of improved genomic,
proteomic, metabolomic profiling tools and instrumentation for the detection
of unintended effects.
- There is a need for a worldwide accessible database, linked to ongoing
efforts in this area, with information on detection and identification methods
and reference materials for food products derived from GM animals on the market
and in development.
- Case-by-case environmental risk and benefit assessment of GM animals should
assess each transgenic line (i.e. individuals with a single transgenic genotype)
with regard to local conditions of the environment, farming system and human
food system. It is essential to assess the whole life cycle of the animal,
for instance, by estimating net fitness, to predict the likelihood of environmental
spread of the GM animal or its transgenes. Established principles of contemporary
evolutionary biology, population biology and ecology should be applied to
risk analysis and safety verification.
- There is a need for better predictive models and data sets for environmental
risk assessment. Methods used to generate data must be validated, and data
sets must be generated to fill key gaps in current knowledge.
- Standardized methods for the confinement of genetically modified animals
should be developed and validated to manage risk for cases where environmental
spread of GM animals or their transgenes poses food safety risks. Redundant
measures may be needed for confinement to prove reliable. There is also a
need for improved methods of sterilizing certain genetically modified animals
and for robust verification regimes for all species.
- There is a need for capacity building, particularly in developing countries,
for food safety assessment and management of GM animals, including environmental
and ethical aspects related to food safety.
- The Consultation encouraged strengthening coordination among national government
and intergovernmental agencies responsible for food safety, environment, agriculture
and trade when it comes to assessing and managing the risks posed by GM animals.
This is also essential for addressing the unintended entry of GM animals that
are not intended for human food into the human food supply.
- The Consultation recommended participatory deliberation by all stakeholders
and the general public, including communication about potential benefits,
risks and uncertainties posed by the genetic modification of animals in order
to promote public knowledge and trust. Participatory deliberation should occur
at an early stage of product development and at key points in the decision-making
process.
- Since no universal framework for the practical assessment of ethical aspects
of animal biotechnology has yet been widely embraced by various parties, it
is recommended that WHO and FAO together with other relevant bodies seek to
work out relevant frameworks for this task. These frameworks should make ethical
assessments more transparent and more methodical, and thus amenable to quality
assurance.
