A shepherd for transgenic animals.
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The aim of the present paper is to review the known and theoretical risks for in vivo derived and in vitro produced embryos as well as for nuclear transferred or transgenic embryos in terms of animal diseases or diseases of public health consequence. For in vivo derived embryos, a considerable number of experiments and scientific investigations have resulted in recommended guidelines and procedures that ensure a high level of safety. The effectiveness of these measures has been validated by field experience with the safe transfer of several million embryos over the past three decades. In vitro produced embryos have several characteristics that differentiate them from the former, in particular a structure of the zona pellucida that results in a more frequent possible association of pathogens with the embryo. However, the guidelines prescribed by the IETS, the international standard setting body (OIE) and existing national regulatory frameworks are in place to minimize the risk of disease transmission. No specific public health risks have been identified to date with respect to in vivo or in vitro derived embryos. In regard to nuclear transferred and transgenic embryos, theoretical risks have been identified in relation to the potential effects on some intrinsic viruses such as endogenous retroviruses but very little targeted experimental work has been carried out on infectious diseases that could have adverse consequences on animal or human health. Although there has been no report of such adverse consequences associated with the limited number of animals produced to date by such reproductive technologies, a precautionary approach is warranted given the potential negative impacts and it would be prudent to restrict at this stage, the international movement of such "manipulated" embryos.
Transgenic crops producing insecticidal toxins from Bacillus thuringiensis (Bt) are widely used to control pests, but their benefits will be lost if pests evolve resistance. The mandated high-dose/refuge strategy for delaying pest resistance requires planting refuges of toxin-free crops near Bt crops to promote survival of susceptible pests. We report that pollen-mediated gene flow up to 31 m from Bt maize caused low to moderate Bt toxin levels in kernels of non-Bt maize refuge plants. Immunoassays of non-Bt maize sampled from the field showed that the mean concentration of Bt toxin Cry1Ab in kernels and the percentage of kernels with Cry1Ab decreased with distance from Bt maize. The highest Bt toxin concentration in pooled kernels of non-Bt maize plants was 45% of the mean concentration in kernels from adjacent Bt maize plants. Most previous work on gene flow from transgenic crops has emphasized potential effects of transgene movement on wild relatives of crops, landraces, and organic plantings, whereas implications for pest resistance have been largely ignored. Variable Bt toxin production in seeds of refuge plants undermines the high-dose/refuge strategy and could accelerate pest resistance to Bt crops. Thus, guidelines should be revised to reduce gene flow between Bt crops and refuge plants.
Under the umbrella of the International Organisation of Biological Control (IOBC), an international working group of public sector scientists entitled on "Transgenic Organisms in Integrated Pest Management and Biological Control" has been organized. The group will develop scientific principles and detailed scientific guidelines for biosafety testing of transgenic crops. The key elements of this project are: (1) An international initiative including expert scientists from leading research institutions in developed and developing countries; (2) coordination of the development and implementation of the guidelines as a dynamic process, which will include scientific and technical capacity building and communication among scientists and between scientists and policy makers; (3) rapid serial publication of sections of the guidelines as they are completed; and (4) rapid and timely revision of previously published sections. The guidelines will be constructed on a case-by-case basis and will have no regulatory legitimacy themselves.
The generation, evaluation, and presentation of data from the ILSI Alternatives to Carcinogenicity Testing (ACT) program was standardized to ensure that the results of studies performed in multiple laboratories could be reliably compared. To this end, standardized experimental protocols, tissue collection procedures, histopathology nomenclature, diagnoses, and terminology were employed by study participants. In the experimental phase, this approach provided important cross-model consistency. To ensure comparability in the data evaluation phase of the project, interpretive criteria were defined to allow the characterization of study outcome as positive, negative, or equivocal in regards to carcinogenic response. These criteria helped to provide consistency across models because separate Assay Working Groups were established to evaluate the results of each model. To organize and compile the data from the ILSI ACT program, a database has been developed and data entered in standardized format to facilitate cross- and intramodel comparisons. In summary, the early development of standardized test protocols, evaluation procedures, and interpretive criteria has resulted in a data set in which users can have a high level of assurance that results in the database reflect consistently applied experimental and interpretive guidelines.