|
Transnational Impacts of Animal Welfare Regulations
The transnational impacts of animal welfare regulations were the subject of a symposium at the
International Union of the Physiological Sciences (IUPS) Congress in San Diego. The April 3 session was sponsored by the APS Animal Care and Experimentation (ACE) Committee and co-chaired by Kevin Kregel and Pontus
Persson. The symposium addressed scientific and practical challenges posed both by differences in animal welfare standards among nations and efforts to reconcile these differences, a process known as harmonization.
In his introduction, Kregel, a Professor of Exercise Science at the University of Iowa and Chair of the ACE Committee, explained that new animal welfare standards currently under discussion in Europe could affect researchers throughout the world. Some of the draft proposals are a particular source of concern because they would require significant changes in animal husbandry. Moreover, there is little scientific data showing that these changes would improve the welfare of animals. Of particular concern, according to
J.R. Haywood, Chair of the Department of Pharmacology and Toxicology at Michigan State University, is the need to recognize that animal welfare standards represent a means to accomplish good science and should not be seen as an end in themselves.
Anne-Dominique Degryse, DVM, Head of Laboratory Animal Resources at the Pierre Fabre Research Center in France described the discussions underway in Europe and provided some specifics about the proposals. At issue is an effort within the Council of Europe
(CoE) to revise the animal welfare standards contained in the Appendices to a document known as ETS 123, the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes. Degryse explained that since 1997, a CoE working group has held a series of consultations about revising the animal welfare standards set forth in Appendix A of ETS 123. Appendix A addresses the housing and care of animals, safety issues, and broader welfare considerations, such as the behavioral needs of animals. The proposals that emerged from the latest round of COE discussions earlier in 2005 would require significantly more cage space per animal, a strong preference for social housing, and would require environmental enrichments that permit the expression of normal animal behaviors.
Current COE standards require that a dog weighing 20-30 kg must be housed in a pen that is 1.7 square meters or 18.3 square feet. The proposed revision would mandate a pen of at least eight square meters (86.1 square feet) for dogs weighing more than 20 kg. The 1996 revision of the ILAR Guide calls for dogs between 15 and 30 kg to be housed in pens with at least 1.08 square meters (11.6 square feet). One rationale for expanded space requirements is that animals are also supposed to be housed socially unless there is a scientific, welfare, or veterinary justification to house them singly. Nevertheless, even singly-housed dogs would have to have opportunities for communal exercise in a separate area. For scientific purposes, dogs less than 20 kg could be kept in smaller enclosures, i.e., with only two square meters (21.5 square feet) for periods of up to 4 hours. When a metabolic cage is used, it must still be large enough to permit the animal to fully stretch, lie down, and turn around. The other proposed requirements for dogs include a comfortable solid resting area such as a raised bed or platform, opportunities for human interaction, and enrichment requirements that include group housing in pens, chewing objects, and opportunities to exercise. In addition, if natural light is totally excluded, a night light of 5-10 lux must be provided in each housing unit to permit some vision. [and to take account of their startle response. ]
These proposals would have no immediate impact since COE Treaties are only advisory. The COE was created in 1949 to bring about greater unity among European nations based upon the ideals and principles of their common heritage. It operates through Treaties and Conventions that its 46 member nations adopt through ratification, but there are no penalties for failing to comply. Nevertheless, these non-binding proposals are viewed as an international consensus that has been reached through extensive multi-lateral consultations with a wide range of organizations including research, industry, and veterinary medical organizations, as well as animal rights groups.
Of much greater potential significance are the positions adopted by the European Union, which now consists of 25 nations. The EU grew out of the Common Market that was founded in 1957 to promote social and economic progress through open and fair trade. The EU also sets animal welfare standards for its members, and failure to observe these standards can result in financial penalties. Moreover, EU “Directives,” as they are called, must be incorporated into member states’ national laws. Directive EC/86/609, which is currently in force, includes as its Annex II the same housing standards contained in Appendix A of ETS 123. In addition, Directive 2003/65/EC and Council Decision 2003/584/EC include provisions that now make it possible to make direct modification of EU technical Appendices based upon CoE Conventions.
At the same time that the COE is holding consultations on its animal welfare standards, the EU has a Technical Expert Working Group on animal welfare issues. A number of subgroups are addressing questions related to the scope of coverage, ethical review requirements, cost-benefit analyses, and pain severity classifications. Issues under consideration include whether to include invertebrate animals and whether to cover the fetal and embryonic forms of vertebrate species, and if so, starting at what developmental stage. Another topic under consideration is setting species-specific guidelines for approved methods of humane euthanasia.
Pontus Persson discussed the impact of animal welfare regulations on international collaborations and journal publication. Persson is a Professor with the Johannes Mueller Institute of Physiology at Humboldt University in Berlin as well as the Editor of American Journal of Physiology-Regulatory, Integrative, and Comparative Physiology. He noted that some countries lack effective enforcement mechanisms for their welfare regulations and that the growing complexity of regulatory requirements represents a problem, as do national differences between regulations. These differences sometimes mean that researchers in one country are not permitted to conduct certain procedures needed for a collaboration. In terms of publication, national differences may interfere with the ability to get research published. For example, the APS journals will not publish articles based upon research that does not conform to U.S. animal welfare requirements.
David Brooks of GlaxoSmithKline Pharmaceuticals discussed the impact of international animal welfare standards on the pharmaceutical industry. He noted that dealing with differences in animal welfare standards poses many challenges to companies operating in a multi-site and global environment. Pharmaceutical industry research has a number of special characteristics. While much research may be done internally, some may be conducted by contract research organizations or undertaken in collaboration with academic institutions. Another special characteristic is the fact that industry must conduct a wide range of animal studies in order to satisfy the disparate demands of drug discovery, drug development, safety assessment, and regulatory work. Moreover, this work must conform to specific regulatory requirements.
Brooks noted that the “pharmaceutical industry” does not have a unified position on global harmonization of animal welfare standards. In fact, there is even confusion about what the term “harmonization” describes since it could be applied to laws, regulations, standards, minimum standards or best practices. The one point of agreement concerns a recommendation that emerged from a November 2003 ILAR workshop on “The Development of Science-based Guidelines for Laboratory Animal Care.” That recommendation was that new animal welfare standards should be based upon sound science, that they should be demonstrably beneficial to animals, and that they should not create unnecessary burdens for the conduct of research.
Brooks noted that industry has its own concerns about harmonizing internal animal care and use practices to facilitate its research programs between sites, including those of contractors and collaborators.
Harmonization of animal care and use is needed to assure that data obtained are scientifically valid and meet regulatory criteria. Industry also frequently faces obstacles when companies are merged because of differences in practices and equipment. Thus, national differences in regulations are only one of the obstacles to harmonization of animal care and use practices within industry.
Essentially there are two possible ways to approach harmonization, according to Brooks. One option is to use engineering standards based upon the most stringent applicable national regulations. However, this approach is problematic because matching the most stringent set of standards in all facilities is costly and may be difficult to implement since in some cases, there are inconsistencies between regulatory requirements. It is difficult to reconcile these using a prescriptive engineering approach. A second option is to adopt performance-based standards that focus on achieving optimum animal welfare outcomes while allowing some flexibility in terms of how those outcomes are achieved. The Association for assessment and Accreditation of Laboratory Animal Care
(AAALAC), International, accepts the flexible approach of performance-based standards while evaluating animal care and use programs based upon their adherence to the ILAR Guide for the Care and Use of Animals along with any other applicable regulatory standards.
MSU’s Haywood noted that international collaborations using animal models can be expected to increase and that the scientific community needs to participate in the harmonization process to assure that the quality of science is sustained. Team science is on the rise as science becomes more interdisciplinary and communications become easier and as more governments recognize that research generates economic growth. Because animal-based research plays an essential role in biomedical research, specialized resources such as equipment and transgenic animals need to be shared. This represents a challenge because if there are differences in animal care and use requirements, it is difficult to perform well-controlled collaborative experiments.
If the scientific community wants to ensure quality animal care across nations, this raises the question, what is quality animal care? Haywood suggested that the starting point for quality animal care involves ethical principles, guidelines, and/or laws protecting animals in research. It also means standards for housing and husbandry as well as for animal use. In addition, ethical review of protocols is needed, such as what is provided in the U.S. through an animal care and use committee. Finally, there must also be some kind of enforcement mechanism, whether through self-monitoring as performed by IACUCs or through external authority. Most nations have some type of formal animal care oversight, but there are differences both in the kinds of oversight and the nature of the requirements.
Haywood recommended a set of guiding principles that should be applied to ensure maximization both of animal welfare and high quality science. These include the need for a scientific foundation for whatever guidelines are put in place, that the guidelines or standards should be formulated as performance based standards that rely upon outcomes, and that there should be a role for the exercise of professional judgment by laboratory animal veterinarians. This approach is preferable to prescriptive engineering standards, which may not serve the best interests of animal welfare or science.
Haywood also described the international harmonization efforts of the International Council for Laboratory Animal Science
(ICLAS), which grew out of a committee established in 1956 by UNESCO, the International Union of Biological Sciences, and the Council for International Organizations of Medical Sciences. These organizations, which seek to promote international cooperation among national biomedical sciences groups, chartered ICLAS to “promote the humane use of animals in research through recognition of ethical principles and scientific responsibilities.” ICLAS is now seeking to harmonize various national guidelines by applying principles and precepts that have been adopted by international consensus. Haywood said that ICLAS is trying to create working groups consisting of representatives of the ICLAS member organizations along with stakeholders from the larger scientific community, to achieve consensus on topics such as euthanasia and humane endpoints for experimentation.
Another approach to harmonization would be to rely upon a non-governmental accreditation process, such as the one offered by
AAALAC, International. This approach would supplement national governmental oversight with accreditation that relies upon accepted international standards along with that country’s laws, guidelines, and policies.
Haywood urged scientists to get involved in these issues so that efforts to harmonize animal care standards will focus on animal welfare as a means to accomplish science, rather as an end in itself. One way for scientists to get involved is by speaking out to assure the public of their concern for animal welfare. This is particularly important because so much misinformation about the use of animals in research has been spread by animal rights activists. At the same time, scientists also need to find ways to provide input into the development of guidelines, policies, and regulations, such as the ones now under development by the COE.
|
