While policy issues might be considered beyond the scope of this study, the committee took account of their existence in identifying science-based concerns about animal biotechnology. The policy framework ultimately determines the scientific questions that the regulatory process must address, and the manner in which it must address them. Although the committee’s charge is limited to addressing science-based concerns, the committee notes that (1) socially, politically, and ethically determined factors influence both the nature of scientific research and the interpretation of data, (2) how one addresses scientific uncertainty or the importance of various concerns that result from introduction of a proposed technology is influenced by political and ethical considerations, and (3) technologies often have impacts on social, political, economic, religious, and spiritual conditions or values which, in turn, might impact health and the environment.
New technologies, such as biotechnology, often are characterized by a variety of uncertainties resulting in unexpected outcomes. Uncertainties can be placed in three categories—statistical, model, and fundamental. These categories of uncertainty generally correspond to technical, methodologic, and epistemologic considerations respectively, which also can be described as inexactness, unreliability, and insufficient knowledge. Regardless of the category, uncertainty also relates to the difficulty of placing potential impacts into the policy context within which proposed biotechnologies will be addressed.
Biotechnologic techniques can both impact upon, or be impacted by social, political, and ethical factors. Concern exists that certain biotechnologies can favor a particular kind of agricultural system that might induce unexpected and unwelcome changes for certain segments of the agricultural community such as small-scale farmers, or for animals or the environment. Alternatively, those changes might result in increased efficiency in food production for a growing population, improvements in animal welfare, or better protection of the environment. The socioeconomic impacts of animal biotechnologies might be manifest at the level of the individual, family, community, or corporation. For example, religious or cultural groups might have dietary norms or rules that might be violated by genetic engineering of animals used for food.
Regulatory decisions and enforcement are difficult in the absence of an ethical framework underlying regulatory decisions related to animal biotechnologies or a regulatory framework for addressing unique problems and characteristics associated with animal biotechnologies. Ethical considerations range broadly, generally are normative, and cannot be resolved scientifically. Some people, irrespective of the application of the technology, consider genetic engineering of animals fundamentally unethical. Others, however, hold that the ethical significance of animal biotechnologies must derive from the risks and