Animal well-being, the safety of animal food products and regulatory issues are addressed in this report along with the examination of links between animal biotechnology and new opportunities in human and animal medicine.
Animal well-being: Will developments in animal biotechnology produce new or unanticipated issues for the well-being of agricultural animals? The two groups - representing animals and representing agriculture - discussed the criteria for extending concern to animals. Is it ethical to balance the relief of human pain and suffering from genetic diseases with the large numbers of animals that would experience great suffering? There was consensus that it is acceptable under conditions where animals do not experience great suffering, to use animals for human use—whether for food production, as “bioreactors,” or as research models for improving human and animal health.
Links to Human Health: Recombinant DNA research in animal science continues to establish breakthroughs in reproductive technology, enhance genetic changes in animals and improve animal health and often spills over to human applications. However, researchers can expect to face some of the problems that have existed in public health and the biomedical research policy arena for some time such as intense public interest in reproductive technologies, in part because of their relevance to the abortion issue, and also a level of public concern for the well-being of animals exceeding that hitherto experienced in connection with food animals.
Communication: If biotechnology is to gain public acceptance, policies must be developed within an open framework for input by all interested stake-holders. Public concerns and questions about biotechnology must be addressed in a manner that inspires confidence in the regulatory process.
Defining Food Safety: Factors influencing confidence in food safety include whether the food is being produced and provided through a trustworthy source. Many participants agreed that non-science factors (e.g., social, economic) can influence whether a source is deemed trustworthy and should be considered in the assessment of foodborne risk.
Regulatory Policy: There is a need for clear regulatory policies for agricultural biotechnology for food, pharmaceuticals or animal use. There is frustration on the side of industry faced with different regulations depending on product classification as a drug or a food. However, there are several areas, including fish and wildlife, where animal scientists are undertaking biotechnology research in the absence of clear regulatory authority.
Greater public understanding of biotechnology processes and products and greater public participation in the decision-making process is essential, if agricultural biotechnology is, indeed, to be the growth industry of the 21st century.
As of this NABC meeting (May, 1992), the regulation of genetically engi-neered animals is hopelessly inadequate, with little hope for improvement. As long as the Council on Competitiveness sets policy, existing statutes are unlikely to be implemented to regulate genetically engineered animals and no new legislation will be sought to provide the new authority needed. From an environmental standpoint, the current situation means that the risks posed by engineered animals to the environment—whether from acci-dental or deliberate release—will go unassessed and uncontrolled. Moreover, without regulation there will be few opportunities for the public to know what is coming or to participate in decisions about the technology. The bot-tom line is that the new policy leaves it up to industry and scientists to decide what kind of animals to make and when and how they should be released. The rest of us must simply hope that their choices will not lead to environ-mental degradation and disaster. This policy of secrecy and exclusion of the public is a recipe for disaster- both for the environment and for the biotechnology industry.
Workshop report covering the safety of transgenic animals and animals administered recombinant DNA products; biotechnological tools to enhance food safety and quality; and communicating with the public.
The regulatory agencies consider oversight as appropriately applied in direct proportion to the risk associated with a given product per se, independent of the technology employed in the manufacturing process. FDA cannot legally take socioeconomic considerations into ac-count in the premarket drug approval process; animal drugs must be evaluated on the basis of the objective criteria of safety and efficacy. However, FDA does not operate in a political vacuum and in a situation where heated political debates on the socioeconomic aspects of a new animal drug run concurrently with the regulatory evaluation of the drug, it is hard to believe that the agency would not be affected to some degree in its deliberations on the drug.
USDA agencies, including FSIS and APHIS, work closely with consumer-interest groups to inform the public about oversight policies and programs for biotechnology products and to discuss any safety concerns associated with production and marketing. The potential of biotechnology for improving animal health and the quality of meat and meat products is immense. We believe that risk-based regulatory programs will help realize the benefits of the technology for both U.S. consumers and producers.The potential of biotechnology for improving animal health and the quality of meat and meat products is immense. We believe that risk-based regulatory programs will help realize the benefits of the technology for both U.S. consumers and producers.
Informed citizens have good reasons to be wary of promises made for new technologies since it is a challenge to find avenues of communication between them and the proponents of animal biotechnologies. Citizens have learned to require honesty, patience and respect from the proponents of new animal biotechnologies. They must be told who finances the research and who will benefit, as must their impact on the farming community and the environment be carefully studied.
Introducing food products into the market place requires that the safety aspect be fully analyzed and documented so that healthy transgenic animals will be at least as safe as the traditional animals from which they were derived. The insertion of a transgene into a recipient genome, however, is a safety consideration because the location and manner of insertion may increase or decrease the expression of host genes. The safety of gene products may be reviewed in the same way the safety of drugs or pesticides are classically reviewed, i.e., the important food safety matter is the presence of a pharmacologically or toxicologically active residue. Once the safety of the transgene product is established, transgenic animals may be considered as safe as traditional animals.
Results of research in animal agriculture have affected certain aspects of clinical medicine. The application of biotechnology to human and veterinary medicine involves many techniques used in reproductive biology and applied in animal agriculture. Transgenic animals are being used for the study of specific genetic defects. Biotechnology represents one approach which can be used to examine questions of interest to the biomedical community and establish linkages between animal agriculture, veterinary medicine and human medicine
Biotechnology offers many opportunities to improve agriculture and will have its greatest impact on meat and poultry safety in two ways by providing us with diagnostic tests to effectively detect contamination during food production and it will enable the production of healthier animals through improved vaccines, diagnostic tests and the ability to produce disease resistant animals.
Advances in biotechnology and animal science will assure the world new methods of increasing the abundance, quality and variety of foods. These future products will be cheaper and safer to produce and will lead to superior, safer and environmentally friendly management options for animal agriculture.
Transgenic animals will be created to study human genetic disease as soon as the technological capability exists to do so. Extant laws permit such animals to be created. The mindset of the research community makes it inevitable. It is also clear that such diseases can cause enormous amounts of pain and suffering. Responsible researchers need to explore all possible avenues for controlling such pain and suffering. Thus far the research community has not engaged this issue vis a vis animals. The development of methodologies for controlling pain and suffering is likely to be exportable to numerous areas of animal research, not only trans-genic creation of disease.
Animal agriculture contributes to the quality of human life by providing high-quality, nutrient-dense foods. Farmers have a moral obligation to produce this food as efficiently as possible. This will provide the maximum amount of human food while minimizing the consumption of natural resources and effects on the environment. Biotechnology should be used like any other tool to help achieve this goal.
The history of participatory procedures suggests this may not produce consensus; when technologies embody highly controversial political and social values, consensus is not a feasible goal. Controversial issues must be defined in terms of problems to be solved rather than solutions to be accepted. Further developing trust is a long-term process built on evidence of reliability and openness established over time. By sorting out conflicting values, they may reduce public mistrust of administrative institutions and, in the long run, encourage the development of equitable decisions.
There are ethical and religious, legal and political, social and economic, environmental and cultural dimensions to animal biotechnology. When these are ignored, the gap between private/corporate and public interests widens. This concern does not represent anti-science or anti-progress leanings, but a more informed public. Patenting of the techniques of biotechnology, rather than its products, including transgenic animals would be more acceptable.
Stenholm, Charles W.; Waggoner, Daniel B. (NABC, 1992)
World agriculture stands at the threshold of new scientific and technical developments in animal science, biology, chemistry, genetics, agricultural engineering, information technology and many other fields. Emerging technologies, industry economics and public policy will play critical roles in shaping U.S. animal agriculture in the decade of the 1990s. Legislative and regulatory activities have a greater effect on animal agriculture each year. In this fast-moving technological environment, it will be necessary to regularly review the appropriateness of the scientific basis of existing regulation and to make any required adjustments in either the technology or the statutory framework.
Every biotechnology is different. Each gene construct is different and must be examined for its individual benefits and risks. Some biotechnologies reduce the need for animals in research or reduce the numbers needed for food production; protect the health of the animal or make it more fit for a changed environment; or allow for the preservation and rapid repopulation of an endangered species. Biotechnology is a series of tools that must be used by humans or risk condemnation and rejection of the tool.