7
Concerns Related to Scientific Uncertainty, Policy Context, Institutional Capacity, and Social Implications

Most of the concerns about animal biotechnology addressed in this report involve potential impacts on human or animal health and the environment. These are among the specific science-based concerns that regulatory agencies might consider in formulating regulatory policies and in making decisions about specific applications of biotechnology to animals. To address these concerns in a scientifically sound and publicly acceptable manner, however, it also is important to consider the scientific, policy, institutional, and social context in which the concerns about animal biotechnology are arising and will be addressed. This chapter does not attempt to address these issues exhaustively, but enough to convey the broader intellectual, public policy, and social dimensions of how society likely will respond to the scientific concerns raised in this report, and to underscore the need for public participation in decisions about animal biotechnology. Nonscientific concerns should not alter scientific analysis, but they will inevitably and properly influence the procedural framework within which scientists address questions that have regulatory consequences, and they will shape the public policy response to science-based health and environmental concerns.

SCIENTIFIC UNCERTAINTY

Scientific uncertainty is an important part of the context for animal biotechnology. Uncertainty is a common feature of regulatory decision-making.



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Animal Biotechnology: Science-Based Concerns 7 Concerns Related to Scientific Uncertainty, Policy Context, Institutional Capacity, and Social Implications Most of the concerns about animal biotechnology addressed in this report involve potential impacts on human or animal health and the environment. These are among the specific science-based concerns that regulatory agencies might consider in formulating regulatory policies and in making decisions about specific applications of biotechnology to animals. To address these concerns in a scientifically sound and publicly acceptable manner, however, it also is important to consider the scientific, policy, institutional, and social context in which the concerns about animal biotechnology are arising and will be addressed. This chapter does not attempt to address these issues exhaustively, but enough to convey the broader intellectual, public policy, and social dimensions of how society likely will respond to the scientific concerns raised in this report, and to underscore the need for public participation in decisions about animal biotechnology. Nonscientific concerns should not alter scientific analysis, but they will inevitably and properly influence the procedural framework within which scientists address questions that have regulatory consequences, and they will shape the public policy response to science-based health and environmental concerns. SCIENTIFIC UNCERTAINTY Scientific uncertainty is an important part of the context for animal biotechnology. Uncertainty is a common feature of regulatory decision-making.

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Animal Biotechnology: Science-Based Concerns Indeed, the essence of regulatory decision-making on health and environmental issues is to make judgments, in the face of uncertainty, about whether established standards have been met. Although it is impossible to prove the safety of a product or technologic application with complete certainty, regulatory scientists (scientists who are responsible for scientific evaluations for a regulatory agency) usually operate within established protocols for evaluating the safety of products or technologies and manage uncertainty by applying safety factors when estimating risks and by identifying additional studies that can provide data to reduce uncertainties. In the case of at least some applications of biotechnology to animals, however, scientific uncertainty will be a particular concern, due to the novelty of the health and environmental questions posed, and due to the lack of established scientific methods for answering them. Uncertainties can be placed in three categories—statistical, model, and fundamental. These categories generally correspond to technical, methodologic, and epistemologic considerations, respectively, which also can be described as inexactness, unreliability, and insufficient knowledge (Funtowicz and Ravetz, 1992). Statistical uncertainty—usually centered around the value of a single variable—is reduced most easily by additional data collection, leaving residual uncertainty that can be quantified. For example, the impact of bovine somatotropin (BST) use on milk production, IGF-1 levels in milk, or the incidence of mastitis in treated animals can be studied rather easily, and the probability distribution of values for each of these variables can be determined. Model uncertainty results from not fully understanding interactions among variables in models used to predict the behavior of multivariate systems when one or more variables are changed. Model uncertainty inherently is more difficult to reduce and to quantify than statistical uncertainty. For example, the potential of transgenic fish to enter the natural environment and alter the marine ecology is a new concern for regulators and scientists that brings into play multiple variables and interactions; this issue poses novel scientific questions, and requires new data collection protocols and methods of analysis. Similarly, a transgene might have pleiotropic effects on multiple fitness traits, making the net effect difficult to predict. In Japanese rice fish engineered with a growth hormone transgene, for example, the disadvantage of a reduction in juvenile viability might be more than offset by the advantages of earlier sexual maturity and an increase in female fecundity relative to wild type (Muir and Howard, 2001). The Trojan gene example in Chapter 5 also shows how, as model uncertainty increases, an even more fundamental kind of uncertainty begins to appear. Fundamental uncertainty results from indeterminacy, ignorance, or ignorance-of-ignorance. In the case of novel technologies, existing models might not apply. Moreover, if we are ignorant of the potential existence of a particular hazard, we might fail to consider it at all when attempting to estimate

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Animal Biotechnology: Science-Based Concerns the potential harms or benefits of an activity. Molecular breeding by DNA shuffling, for example, will result in at least some outcomes that fundamentally are uncertain and always will be virtually impossible to predict. We will remain ignorant of them until they occur, and even then, might only identify them if we search in sensitive ways. Attempts to estimate the probability of harm (or benefit) from such a fundamentally uncertain activity must be undertaken with great care since ignorance-of-ignorance might lead to serious errors. The kind and degree of scientific uncertainty have implications for the processes agencies use or devise to reach sound and publicly acceptable decisions (see Box 7.1). In the case of model uncertainty, for example, more effort might be required to engage a broad scientific community in consensus building about protocols for evaluating hazards and to air specific risk assessments publicly. Scientific uncertainty—especially in the model and fundamental categories—also might have implications for public and private research priorities, market-entry standards and processes, and other regulatory policies such as the need for post-approval monitoring and research. BOX 7.1 Error Bias Error biases are important determinants of conclusions drawn from the interpretation of scientific data and, therefore, often have a direct influence on public policy. The impact of error biases might be particularly important when the analysis of complex systems requires numerous assumptions and simplified models in order to attempt to predict system behavior. For new technologies, which might be characterized by fundamental uncertainties, we might be ignorant of what to look for or how to frame a research question, setting the stage for surprises and unpredicted impacts. Error biases usually are set by agreed-upon convention, and hypothesis testing commonly favors Type II errors (false negatives) over Type I errors (false positives). That is, a null hypothesis commonly asserts that there is no relationship between an action and a response in a system, and highly significant evidence typically is required as a basis for rejecting the null. In addition, asking the wrong question or failing to ask the right question, sometimes called a Type III error, also is problematic when dealing with novel technologies. The failure to identify a hazard when it exists (Type II error) might lead to policies that are not protective of health or the environment. Conversely, identifying a technology or product as hazardous when it is not (Type I error) might lead to unnecessary, burdensome regulation or the failure to adopt something useful. With respect to emerging animal biotechnologies, the committee acknowledges that, for many applications, hazard/safety data are sparse, and, in many studies, the number of individuals, populations, or models examined is small. Uncommon or less common events are less likely to rise to statistical significance and might not even be identified in such a limited dataset, resulting in a bias toward Type II error in data interpretation if these limitations are not kept in mind. The likelihood of a Type III error (asking the wrong question) will depend entirely upon how comprehensively and systematically examiners look for the potential impacts of the various technologies.

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Animal Biotechnology: Science-Based Concerns POLICY CONTEXT In addition to posing new scientific questions and increasing scientific uncertainty, the novelty of some of the concerns posed by animal biotechnology raises a policy question about the meaning of the health and environmental safety standards under which the scientific questions will be addressed. The U.S. Food and Drug Administration (FDA) has said that it intends to regulate transgenic fish and other transgenic animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act. This law directs the FDA to license animal drugs that the sponsor has demonstrated to be safe for human and animal health and effective for their intended use, which typically is therapeutic or to promote animal growth and productivity. The meaning of these standards is well understood in the context of conventional animal drugs, and there are well-established scientific protocols for collecting relevant data and evaluating whether the standards have been met. The safety issues are relatively straightforward because they focus on the health of the treated animal and the safety of edible tissues derived from the animal. It might be less clear what these safety standards mean in the context of animal biotechnology. The FDA has said, for example, that it considers the animal safety aspect of the animal drug standard to apply not only to the transgenic animal, but also to wild fish and other animals in the environment that might be affected by the release of the transgenic animal. On this basis, the FDA says it will regulate the environmental impacts of transgenic fish, such as the transgenic salmon currently under FDA review (OSTP, 2001). What does “safe” mean in this context? What environmental impacts and direct or indirect impacts on the health of wild fish and fish populations fall within the scope of the statutory safety standard for animal drugs? What degree of precaution is appropriate in evaluating these impacts? How will the novel scientific uncertainties associated with environmental hazards posed by transgenic fish be managed in regulatory decisions under the statutory safety standards for animal drugs? How will the expertise and perspectives of scientists and other stakeholders be considered by FDA under the animal drug licensing process, which is closed to public participation? It is beyond the scope of this study to address or attempt to answer these policy questions. They are relevant, however, to identifying the scientific concerns over animal biotechnology that government scientific reviewers and regulators will have to address, and to determining the scientific approaches that will be adequate to address them. These policy questions are relevant because the meaning and scope of the safety standard are prime determinants of what agencies must consider a relevant scientific concern. Moreover, the quantity and quality of the scientific data required to address an identified safety concern, as well as whether available scientific protocols are adequate to collect the needed data, are a direct function of the degree of precaution the regulatory agency considers appropriate and the degree of scientific uncertainty it deems

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Animal Biotechnology: Science-Based Concerns acceptable. These are questions yet to be addressed and resolved in the context of transgenic animals. Another policy-related concern is the regulatory environment with respect to animal welfare. The animal welfare regulatory system in the United States is complex. Livestock used for biomedical research are covered under the Animal Welfare Act Regulations (AWRs) and the Public Health Service (PHS) Policy, which also covers research projects funded by national research institutes like the National Institutes of Health. Fish and birds used in biomedical research funded by national research institutes also are covered under the PHS policy, but are not regulated by the U.S. Department of Agriculture (although the USDA has announced its intention to regulate birds). Both the PHS policy and the AWRs require that animal research protocols be reviewed and approved by an Institutional Animal Care and Use Committee prior to their initiation. The intent of such review is to ensure that animal pain and distress are minimized, that alternatives have been investigated, and that the minimum number of animals necessary to achieve research goals is used. There is no such requirement for review of production-related (i.e., food and fiber) research protocols involving animals, although voluntary standards for such review are available (in the so-called Ag Guide; FASS, 1999). This two-tier system means that research projects involving biomedical uses of genetically manipulated farm animals for xenotransplantation and pharmaceutical production will be reviewed for their potential impacts on animal welfare, and the animals involved in those projects will be subject to some type of oversight. Those projects directed toward genetic manipulation for improved food or fiber production, on the other hand, might or might not be subject to such review and oversight, depending upon whether or not the institution at which the research is conducted has chosen to adopt the Ag Guide or a similar set of standards. An additional concern relates to the effect of the patent process on animal welfare. If technologies to reduce the number of animals used in transgenesis, or to reduce the incidence of developmental abnormalities, become available but are patented, those technologies might not readily be accessible to producers and marketers of genetically engineered animals. Less sophisticated technologies that have more negative impacts on animal welfare might thus continue to be used for the production of transgenic animals. INSTITUTIONAL CAPACITY The institutional framework for regulation of animal biotechnology affects how science-based concerns about the technology will be identified and resolved. The committee has identified features of the institutional framework that raise concerns, including the multiplicity of agencies and statutes potentially involved in regulatory oversight of animal biotechnology and the legal and

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Animal Biotechnology: Science-Based Concerns technical capacities of the agencies to address some of the novel questions posed by the technology. Agencies and Statutes Appendix B lists the many components of the federal government that might have jurisdiction over some aspect of animal biotechnology. They include potentially four different centers within the FDA and two agencies in the U.S. Department of Agriculture that have some jurisdiction over the animal and/or human health impacts of animal biotechnology, depending on the nature and intended use of the product involved. In addition, some of these components of government, such as the FDA’s Center for Veterinary Medicine (CVM), have said that they will regulate the environmental impacts of the technology, but there are additional agencies that also might have a role on environmental issues, such as the U.S. Army Corps of Engineers (ACE), the Environmental Protection Agency (EPA), the Fish and Wildlife Service (FWS) in the Department of the Interior, the National Marine Fisheries Service (NMFS) in the Department of Commerce, and various state-level environmental and natural resource agencies. Each of these agencies operates under its own distinct statutory mandate and mission, which necessarily influences the nature of the scientific questions that they will consider important in carrying out their responsibilities. In the case of transgenic fish, for example, the CVM claims primary jurisdiction over environmental issues, but the ACE has jurisdiction under the Rivers and Harbors Act over the siting of aquaculture facilities in navigable waters, where net pen salmon facilities commonly are found. Under this act, which gives the ACE broad discretion on whether and how to act on environmental matters, the ACE balances a host of concerns, including conservation and environmental impacts, and, like CVM, is subject to its own assessment requirement under the National Environmental Policy Act (NEPA) in making siting decisions. The FWS and NMFS have regulatory roles under the Endangered Species Act to the extent that the siting of an aquaculture facility or any other government action could affect an animal on the endangered species list, such as Atlantic salmon. And the EPA already has invoked its Clean Water Act authority to regulate discharges from salmon aquaculture facilities in Maine (Lubber, 2000), and potentially could do so again with transgenic fish facilities. Multiple agencies also are potentially involved in food safety aspects of animal biotechnology. While CVM claims jurisdiction over the genetic transformation of livestock under its animal drug authority, meat from slaughtered animals will be inspected by the Food Safety and Inspection Service of the U.S. Department of Agriculture. At the federal level, milk is under the jurisdiction of a different component of FDA, the Center for Food Safety and

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Animal Biotechnology: Science-Based Concerns Applied Nutrition, which has the FDA’s core expertise in food safety and nutrition. Milk inspection, however, is handled primarily at the state level. The multiplicity of agencies and statutes potentially involved in regulating the safety and environmental aspects of animal biotechnology is a concern for scientists and other stakeholders, who will be seeking clarity about the scientific standards, data requirements, and analytical approaches to be applied in making market entry decisions. Without this clarity, it will not be possible to gather the necessary data with efficiency, and with confidence that the data will be scientifically sufficient and meet the government’s regulatory needs. Moreover, without clarity concerning scientific requirements and the allocation of responsibilities among the federal agencies, the public will have difficulty understanding, evaluating, and ultimately, gaining confidence in the government’s decisions. The committee notes a particular concern about the lack of an established regulatory framework for the oversight of scientific research and commercial application of biotechnology to arthropods. As discussed in Chapter 5, genetically engineered insects could pose substantial and difficult-to-assess environmental hazards, and could present especially difficult containment issues, yet research and commercial experimentation is proceeding without any regulatory oversight (Hoy, 2001). In addition to the potential lack of clarity about regulatory responsibilities and data collection requirements, the committee notes a concern over the legal and technical capacity of agencies to address potential hazards, particularly in the environmental area. The CVM’s statute—the animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FDC Act)—for example, was enacted to address the safety of animal drugs with respect to the treated animals and any residues that remain in edible tissue, such as meat, milk, and eggs. The statute seems well designed for this purpose, and the CVM has extensive experience and expertise in addressing these safety issues. The FDC Act is not, however, an environmental statute. It thus is unclear whether the “health of man or animal” language in the FDC Act’s definition of the safety standard for animal drugs will be broad enough to sustain FDA’s regulatory authority over broad, systemic effects of animal biotechnology on ecosystems, such as harms to centers of origin and other genetic resources, or a decline in the resilience of a fish community (Kapuscinski, 2000). Nor is the CVM an environmental agency by mandate or tradition. Moreover, the agency lacks expertise in specialized areas that are relevant to assessing the environmental impacts of animal biotechnology, such as marine ecology and evolutionary biology. The committee’s concern in this area is underscored by the novelty of the environmental impact questions potentially posed by animal biotechnology and the methodologic uncertainties about how to assess and manage those impacts. Assessing the environmental and ecologic risk posed by a transgene release is complex in part because multiple outcomes are possible for any transgene. This is to some extent inherent in the nature of random insertion of DNA. Each gene

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Animal Biotechnology: Science-Based Concerns construct used to transform each species, or even the same construct in different fish of the same species, might produce a unique risk of gene spread (Chen et al., 1994). Several reasons underlie such variable outcomes, including alternative insertion sites and copy number of the transgene, genetic regulatory mechanisms, the effect of transgenes on the target trait as well as effects on other traits, and the scale and frequency of their introduction into the natural population (Kapuscinski and Hallerman, 1990; 1991). Thus, it is necessary to consider whether, because of random gene insertion, each founder poses a unique risk. The complexity of predicting environmental impacts is compounded by the nearly infinite number of direct and indirect biotic interactions affecting gene spread that occur in nature, and the fact that populations of a species can evolve in response to a hazard. Predictive, fitness-related models have been developed (Muir and Howard, 2001; 2002a; Hedrick, 2001), but they have not been tested in a regulatory context, and they involve scientific issues different from those normally addressed by the CVM. Commercial application of animal biotechnology might require adoption of containment strategies to reduce the risk of gene spread and adverse environmental impact. In the case of transgenic fish, mechanical (e.g., screens at water inlets and outlets), physical (e.g., lethal pH or temperatures applied to rearing unit effluent water), and biologic containment approaches have been developed and might be applicable to minimize unintentional release into the environment (Devlin and Donaldson, 1992). Biologic containment, which might be especially important due to the high likelihood of escape from mechanical or physical containment, can be achieved through various means, including sterility by induced triploidy (Benfey, 1999) and by a mix of hormonal and transgenic methods (MacLean and Penman, 1990; Devlin and Donaldson, 1992). There remain, however, uncertainties about the efficacy of various containment measures and what degree of efficacy is appropriate or acceptable in various circumstances (Muir and Howard, 1999; Kapuscinski and Hallerman, 1990; Devlin and Donaldson, 1992). Again, these are issues that the CVM generally has not had to address in the past. The committee’s concern about legal and technical capacity is not limited to the CVM. It is not clear to the committee whether any of the agencies with a possible regulatory role in overseeing the environmental impacts of animal biotechnology has a clear and adequate mandate and the necessary scientific and technical expertise to address these potential impacts. The committee has not made an exhaustive inquiry on this point and has drawn no conclusions, but it believes that the legal and technical capacity of the agencies in the environmental area is a significant concern.

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Animal Biotechnology: Science-Based Concerns SOCIOECONOMIC, CULTURAL, RELIGIOUS, AND ETHICAL FACTORS The commercialization of animal biotechnology will occur in the context of existing agricultural and social systems. This technology has the potential to affect a host of social, economic, religious, cultural, and ethical values and interests inside and outside of the agricultural system. Some of these effects might directly be relevant to the mandates of the regulatory agencies. Many are not directly relevant to regulatory mandates, despite their importance to citizens and society. Experience with biotechnology has taught, however, that, even when the social and economic aspects of the technology are beyond the regulatory jurisdiction of an agency, they can affect the questions regulatory agencies are pressed to address by various groups, and sometimes can dominate the public debate in ways that have unavoidable spillover effects on the regulatory process. For this reason, the committee considers it appropriate to identify some of the potential social implications of animal biotechnology. The committee notes as a concern the need for the regulatory agencies to be clear about the scope and limitation of their mandates to address such matters that do not directly affect health, the environment, and animal welfare. Lack of clarity on which issues are within the regulatory mandate and which need to be addressed in other settings could undermine the ability of the agencies to address health and environmental concerns in a scientifically sound and publicly acceptable manner. Industry Structure and Indirect Health, Animal Welfare, and Environmental Effects An important economic issue surrounding both plant and animal biotechnology is whether the technology is scale-sensitive—that is, whether it is equally viable economically for both small-scale and large-scale farmers, or whether it favors large-scale or “industrial” styles of agriculture. This question is posed in light of the well-documented trend toward concentration (fewer but larger farms) in U.S. agriculture and a concern that more intensive approaches to plant and animal production can have their own health and environmental impacts. A large body of scholarly work identifies complex linkages among technologies, their impacts on social systems, and resultant health effects (Barbour, 1993). The “Green Revolution” in agriculture provides many examples throughout the world. The introduction of hybrid seed varieties into high-input, mechanized, industrial farming practices resulted in changes in land use practices and fundamentally changed the social structure of some communities (DeWalt, 1988). In some instances, creation of habitat favorable to mosquito vectors led to increases in the incidence of malaria (Cleaver, 1972;

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Animal Biotechnology: Science-Based Concerns Sharma, 1999; Middendorf et al., 2000). Because the Green Revolution involved many technical changes, it sometimes is difficult to understand cause-and-effect relationships among the new cultivars, pesticide use, mechanization, land use, and environmental changes, and their social and public health impacts. However, the Green Revolution clearly demonstrates that commercialization of cultivars with relatively simple genetic changes can have major effects on farming practices that ultimately result in environmental and social change (Conway, 1998). Some have suggested that the use of certain biotechnologies in vertically integrated agricultural operations producing swine and poultry inherently favor a particular kind of large-scale agricultural system under the increasing control of large corporations, with resultant unfavorable economic impacts on smaller-scale farmers and producers (Martinez, 1999). Large-scale agricultural operations might, in turn, have a very different impact on both the natural environment and communities of people than other systems of food production. For example, swine genetically engineered for disease resistance might be raised successfully in increasingly large, crowded feedlots, with resultant impacts on public health and the environment (Cole et al., 2000). In this case, it is difficult to ignore the contribution of the technology to this sequence of events, even though the genetic engineering of swine is not the proximate cause of the impacts. Concentration in agriculture is the result of many complex economic forces, of which technologic change is just one. The degree to which animal biotechnologies will contribute to a shift from smaller-scale to larger-scale operations, however, sometimes is unclear (Martin, 1991). For example, genetically engineered pigs have been developed to produce phytase, an enzyme that reduces the phosphorus content of manure when the animals’ feed contains phytate from plant seeds. The environmental problem(s) posed by phosphorous-rich manure might differ among small- and large-scale agricultural operations. Whether or not genetically engineered pigs able to utilize phytic acid directly in their diet will be equally beneficial to or affordable by small- and large-scale farmers remains to be seen. These examples suggest that the environmental and social impacts of the shift to larger agricultural operations in some cases might be attributable—at least in part—to the adoption of the genetic technology, though they might not be apparent in an evaluation that focuses narrowly on the direct impacts of the technology. The committee’s concern is that there be clarity about whether the regulatory agencies consider it their charge to consider: (1) only the direct health and environmental impacts of a technology, where the technology is the proximate cause of an effect, or (2) also, the social or economic impacts of a technology that can cause an adverse health or environmental impact. The Green Revolution teaches that the scope and size of the social and economic impacts are difficult to predict in the early stages of introducing a technology into the marketplace.

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Animal Biotechnology: Science-Based Concerns Religious, Spiritual, and Cultural values Some religious, spiritual, ethnic, or cultural groups prescribe dietary norms or rules that include foods that are to be avoided. These norms or religious traditions might be violated by genetic engineering of animals used as food. A genetically engineered animal might contain a gene or gene product from a prohibited animal, or the mixing of genetic elements from distinct species itself might be prohibited. For example, a human protein derived from biopharming might enter the human food chain if animals are not properly segregated. These techniques might affect the acceptability of the food product to some members of the general public, and have obvious implications for any potential labeling policy (see Box 7.2). BOX 7.2 Labeling There has been considerable debate and continuing controversy in the United States and globally about the labeling of foods derived from genetically engineered plants. The committee recognizes the importance of the labeling issue and its potential relevance to animal biotechnology. The current FDA labeling policy requires that foods derived from genetically engineered plants be labeled to inform consumers if there has been a change in the food that would be material to them with respect to safety or nutrition. The committee assumes that a similar policy would apply to foods derived from genetically engineered animals. To date, no genetically engineered plants or food derived from such plants have required labeling under this policy. Labeling currently is not required in the United States, however, solely to inform consumers that the food was derived from a genetically engineered plant. Some have challenged this policy on the ground that there are reasons—beyond safety or nutrition—for a consumer to want labeling of food derived from genetically engineered plants or animals, including religious, ethical, right-to-know, or simple preference reasons. It could be argued that in the current climate surrounding biotechnology, the fact of genetic engineering is an aspect of the identity of a food derived from a genetically engineered organism. The committee notes, however, that while any one or all of these reasons might provide a legitimate basis in public policy for requiring labeling of biotechnology-derived foods, these are not science-based concerns, and whether they justify labeling is beyond the committee’s charge. In the event labeling is required, however, whether for safety, nutritional, or other reasons, implementation will pose science-based concerns having to do primarily with the availability of simple, reliable test methods to verify whether foods are labeled properly with respect to genetic engineering. The availability of such methods also might be a concern in the event that marketers of food derived from genetically engineered organisms seek to segregate their products from non-genetically engineered food for commercial reasons. The committee acknowledges these technical issues regarding the implementation of labeling and segregation regimens but considers them beyond the scope of its charge.

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Animal Biotechnology: Science-Based Concerns Ethical Considerations Ethical considerations might be applicable to the processes involved in biotechnologies as well as the products derived from them. Ethical considerations, of course, are not new to the specific biotechnologies discussed in this report, but the general public often makes ethical distinctions among genetic engineering in plants and animals for biomedical research, for pharmaceutical production, and for food production (Sparks, 1995; Frewer et al., 1997). Ethical considerations generally are normative and cannot be resolved scientifically. Yet, to ignore them is to assume that science can and should be value-free—an obvious contradiction, since this is a normative assertion in itself (Thompson, 2001). Moreover, as noted above, values can influence both the design of scientific inquiry and the interpretation of data, and certainly can motivate much of the pressure brought to bear on regulatory agencies and other government bodies to address impacts of biotechnology beyond those directly affecting health and the environment. One view, which focuses on the consequences of applying animal biotechnologies, holds that their ethical significance must derive from the risk to people, animals, and/or the environment (Rollin, 1986; Thompson, 2001). This utilitarian conceptualization sees the technology as directly or indirectly initiating event(s) that are knowable and, to some extent, quantifiable. Through this lens, an ethical analysis would, for example, address the degree of pain and suffering of animals and/or defined risks to human health or the environment, and would draw conclusions based on those consequences. Of course, quantifying pain and suffering or risks associated with hazards about which there is considerable uncertainty remains a significant problem. In fact, some people conclude that because some genetic technologies are characterized by large uncertainties about their consequences, and for high-stakes decisions, it is morally irresponsible to proceed with their application (The Royal Society, 2001). Some people, however, without regard to the purpose to which the technology is to be put or its consequences, consider genetic engineering of animals fundamentally unethical. This stance might be based on the belief that these technologies violate certain rights or appropriate relationships between humans and nature or God, independent of the consequences of the technologies. This stance also might be based on the conviction that animals have certain rights. Sentience, or the capacity for sensation or feeling, sometimes is used as the quality necessary for moral consideration. Another somewhat related view holds that genetic manipulation of animals for human purposes is disrespectful, and inappropriately interferes fundamentally with animal integrity, dignity, or essential nature. In an address to the Royal Society of Agriculture, Heap (1995) stated, “Programmes which threaten an animal’s characteristics and form by restricting its ability to reproduce normally, or which

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Animal Biotechnology: Science-Based Concerns might in the future diminish its behavior or cognition to improve productivity would raise serious intrinsic objections because of their assault on an animal’s essential nature.” Yet another view focuses on the right of humans to know what they are eating or how their food or pharmaceuticals are being produced. That right—in this view—is independent of biologic risk. In this view, food produced through technologies that some people find “unnatural” or simply “novel” would need to be identified so that consumers could make informed purchasing and dietary decisions. Others argue that if the product has not been altered materially and is deemed safe, it should not be singled out as being different, just as milk produced from cows given growth hormone (BST) was not so labeled. Here, the product, rather than the process that produced the product, is the primary concern. Unlike a utilitarian approach that considers risks and benefits in the aggregate, a rights-based perspective also looks closely at the distribution of risks and benefits of a technology and its products among individuals. Distributive justice becomes an important consideration. INTERSECTION OF ETHICS, SCIENCE, AND PUBLIC POLICY Ethical concerns cannot be resolved completely through scientific debate. Yet, the nature, scope, and direction of scientific research and scientific practice are influenced by ethical considerations. Inasmuch as ethical concerns cannot be separated cleanly from scientific concerns, a strong case can be made that the ethical assumptions underlying a research initiative or the application of a technology should be made explicit. The committee acknowledges that each regulatory authority will bring its own scope of inquiry and set of ethical assumptions to attempts to address the science-based concerns posed by animal biotechnologies. A historical review of similar efforts suggests that regulatory agencies are likely to focus almost exclusively on what they believe to be the direct impacts of these technologies on human health, food safety, the environment, and in some cases, animal welfare. How each agency will deal with the scope and degree of scientific uncertainty remains to be seen. The full range of socioeconomic impacts of these technologies, however, though likely to be significant and certainly amenable to study using scientific methods, is unlikely to be examined comprehensively and weighed in regulatory decision-making. Moreover, spiritual and religious considerations are unlikely to be addressed substantively at all. Experience also teaches, however, that the public’s interest in these value-laden matters can affect the work of regulatory agencies, as evidenced by the European experience with plant biotechnology. The committee notes that the technologies discussed in this report are likely to have direct and indirect impacts that will become more apparent over time and will generate considerable debate and uncertainty in some instances.

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Animal Biotechnology: Science-Based Concerns This report was written as these new technologies continued to emerge. It is, therefore, a “snapshot” of a rapidly evolving and complex field of study. It undoubtedly will require revision as new information becomes available.