Animal Biotechnology Science-Based Concerns (2002) / Chapter Skim
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7. Concerns Related to Scientific Uncertainty, Policy Context, Institutional Capacity, and Social Implications
7. Concerns Related to Scientific Uncertainty, Policy Context, Institutional Capacity, and Social Implications
Pages 108-121
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From page 108... ...
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.
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From page 109... ...
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.
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From page 110... ...
Tom 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 7.14.
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From page 111... ...
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.
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From page 112... ...
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.
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From page 113... ...
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.
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From page 114... ...
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.
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From page 115... ...
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)
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From page 116... ...
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.
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From page 117... ...
Whether or not genetically engineered pigs able to utilize physic 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.
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From page 118... ...
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.
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From page 119... ...
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.
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From page 120... ...
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.
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From page 121... ...
SCIENTIFIC UNCERTAINTY AND POLICY CONTEXT 121 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.
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