Animals Used for Scientific Purposes Working Group

Expert Working Group Report - Animals Used for Scientific Purposes

The Canadian Council on Animal Care

1. Definitions: Animal Health, Animal Welfare and Ethics
   1. Definition – Animal Health
   2. Definition – Animal Welfare
   3. Definition – Ethics: Conventional and Ecological
2. Guiding Principles – NAHS Development
3. NAHS – Scope
4. NAHS – Specific Issues to Address
5. Working Group – Scope
6. NAHS – Issues Specific to Animals Used for Scientific Purposes
7. The Strategy – General Outcomes

1. Definitions: Animal Health, Animal Welfare and Ethics

“The NAHS goal is to develop an integrated system that optimizes animal health and welfare”

As stated, it should be an integrated system. The proposed working definition of “animal health” includes animal welfare (appearing secondary to health), rather than recognizing animal welfare as inextricably linked to animal health. This is perceived to be a political decision, the consequences of which should be thoroughly explored.

Conversely, the World Organisation for Animal Health (OIE) introduction to guidelines for animal welfare recognizes “that there is a critical relationship between animal health and animal welfare.”

Additional information can be found under “Guiding Principles for Animal Welfare” on the OIE website at http://www.oie.int/eng/normes/mcode/en_chapitre_3.7.1.htm.

Other countries have an independent National Animal Welfare Strategy in place (e.g. the Australian Animal Welfare Strategy), which can be found at the following address: http://www.daff.gov.au/__data/assets/pdf_file/0011/146747/Aaw_Strategy_Final.pdf.

The Animal Health and Welfare Strategy for Great Britain combines animal health and welfare in its strategy and can be reviewed at the following address: http://www.defra.gov.uk/animalh/ahws/strategy/ahws.pdf.

1.1 Definition – Animal Health

The state of a living organism, species or population which can sustain biological functions to preserve its own integrity

If the strategy remains the “animal health strategy,” then, the definition could be simplified to “Health – the state of being well in body and in mind,” which is a definition that includes welfare.

Human health is defined by the World Health Organization as a “state of optimal physical, mental and social well-being,” not merely the absence of disease and infirmity. Animal health is thereby “a state of optimal physical, mental and social well-being which allows for optimal survival and perpetuation (reproduction and other related functions) and includes the absence of disease or infirmity.” To preserve not just “its own integrity” but the integrity of the population or species (in particular, threatened or endangered species), this definition clearly includes reproductive health. The drive for survival, in fact, is very strong and can co-exist with ill health. For optimal animal performance and thus animal health, there must be ecosystem health.

The definition should include a way to determine when health is compromised and where actions/interventions are necessary to return a state of health to acceptable, or when to enforce sanctions.

1.2 Definition – Animal Welfare

The state when an animal is in harmony with its environment and its physical health, and behavioural needs are fulfilled – in accordance with expert opinion and scientific knowledge

Truncating the definition at the dash would be a way to define what the state of good welfare is, irrespective of what experts say.

The definition should refer to “the state where an animal is free from distress, in harmony with its environment, and where its physical health and behavioural needs are fulfilled and survival and reproduction are assured, as defined by scientific knowledge (including ethology) and expert opinion.”

This definition is difficult to translate to the population level. Caged salmon, for example, may have a cumulative mortality of 5% from sTocking to harvest, likely much better than in the wild. The 5% that died, however, likely suffered, because there were no predators to terminate their lives more rapidly than by starving in the caged situation.

Similar to the definition of animal health, this definition should include a way to determine when welfare is compromised and where actions/interventions are necessary to return the welfare of the animal to harmony or when to enforce sanctions.

Animal welfare is a complex issue, often seen as including animal health, rather than being a component of health. Science and ethics are both essential when considering animal welfare. Science provides the body of evidence about animals that is used for moral and ethical judgments about their welfare. At the same time, decisions about animal welfare are influenced by cultural, social, economic and occupational health, as well as safety considerations.

1.3 Definition – Ethics: Conventional and Ecological

“Ethics” is derived from the Greek word, ethos, meaning the predominant community spirit. Within that community spirit, morality is the distinction between right and wrong. Philosophers divide “ethics” into 3 distinct but related kinds of inquiry: metaethics, normative ethics and applied ethics. Metaethics investigates where our ethical principles come from, and what they mean. Normative ethics involves a more practical task, which is to arrive at moral standards that regulate right or wrong, good and bad for evaluation and decision. By using tools of metaethics and normative ethics, discussions in applied ethics attempt to resolve controversial issues, such as abortion, environmental concerns, animal rights and the morality of animal experimentation.

“The NAHS is a common vision to develop an integrated system that optimizes animal health and welfare while balancing the interests of animals, humans and ecosystems.”
– Ms. Johanne Beaulieu, Director, NAHS, Minutes of the August 17, 2007,
teleconference of the CCAC Expert Working Group on the NAHS

Balancing the interests of animals, humans and ecosystems will be a difficult practical ethics exercise that will pose several challenges. The Canadian Council on Animal Care (CCAC), has advocated the use of a moral stewardship approach to the ethical use of animals (described further in Section 5). According to Mohandas Gandhi, the greatness of a nation and its moral progress can be judged by the way its animals are treated (Gandhi, 1931).

As a starting point, the NAHS should recognize that animals have value in and of themselves and figure prominently within the strategy.

Other nations have recognized the intrinsic value of animal life within their legislative framework. For example, since the adoption of its Animal Protection Act in 1981, the Dutch Government has acknowledged the concept of the intrinsic value as follows: “Acknowledgment of the intrinsic value of animals means that animals have value in their own right, and as a consequence, their interests are no longer automatically subordinate to man's interests” (Dutch Health and Welfare Act).

“Animals have intrinsic value” (Australian Animal Welfare Strategy).

2. Guiding Principles – NAHS Development

The NAHS should be referred to as “a NAHS,” recognizing it as a strategy that evolves, rather than one that is a static entity. In general, the working group agrees to abide by these principles with the following provisos:

1. Collaborative approach that balances the interests of all partners
   • Note that it is unrealistic to presume that the “interests” of all partners can be balanced. However, animals should not be the losers.
     
   • Take precautions to ensure that the discourse is not derailed by any special interest group.
     
   • Identify who should “speak” for the animals; it is difficult to completely understand all needs of any animal species or individual
2. Accountability and transparency
   • Recognize that the human–animal relationship is complex, that it is utilitarian in nature, and that animals continue to be used and/or consumed.
3. Include evolving science in decision making
   • Be aware that, at times, there is a need to identify who has the larger picture in mind—for example, fish vaccine studies with negative results that will benefit everyone (vaccine companies will not fund), positive results benefit the vaccine company (farmers will not fund), etc. It requires commitment at a higher level to prevent animals from suffering due to suboptimal health management. The entire farming community (or society) must contribute to improving the knowledge base and well-being of animals.
4. Include approaches that allow partners to be responsive, adaptive, flexible and to continually improve
   • Although it may be impossible to always balance the interests of all partners or to respect regional priorities, difficult decisions need to be made, irrespective of factors, such as destroying infected herds in one region of the country to preserve the national farm economy.
5. Ethically driven sustainable decision making and actions
   
   • Clearly state the ethical principles on which decisions are to be based.
     
   • Ensure that there is a principle that relates to “respect for those groups using animals ethically.”
6. Respect for regional initiatives and perspective
   
   • Regional perspectives may be respected; nonetheless, there should be a means to challenge practices that impact the health and welfare of the animals, with a view to working toward change.

3. NAHS – Scope

The NAHS should encompass animals in food production, companion animals, animals used in science, zoo animals and wildlife.

Animal issues: Consider in their own right, not always in relation to the human condition. The idea of environmental health is critical; it is central to the health of all animals, whether terrestrial or aquatic. The scope should therefore include risks to animals from pathogens transmitted between animals. Because many animals are sentinel to specific environments, the scope should include key invertebrate species (e.g. corals, specific insect species, crustaceans) and all vertebrate species.

Human health: The NAHS must comprehensively survey and document the scope of human engagement with animals, the context of the engagement, and risks to humans and animals. These risks stem from human actions to manage animal production systems in a way that creates risks to humans and ecosystems (e.g. mega feedlot or fish farms, their diseases and impact on the ecosystem).
Environment health: Include in the NAHS a careful inventory of non-native, particularly, invasive species, and their impact on native species and the biota.

4. NAHS – Specific Issues to Address

4.1 Address critical habitat preservation to ensure the health and welfare of the animals, recognizing that, without adequate habitat, neither health nor welfare of animals can be guaranteed

• Include issues in relation to maintenance of biodiversity

4.2 Issues relating to pain and to stress

• Determine how to deal with unanswered questions relating to some vertebrate species (e.g. pain perception in fish).
• Address the following questions: Should all animals, species or populations be treated equally (including those not necessarily favoured by the NAHS)? Should this be based on sentiency? Provide definitions for pain and disease in animals.
  
• Identify useful indicators of pain and distress, as well as mitigation strategies, examining barriers to mitigation (e.g. farm income, labour, infrastructure costs, delivery systems, etc).
  
• Address the need for national guidelines for provision of pain control during common husbandry practices in farm animals (e.g. castration, dehorning, branding).

4.3 Include the need for nationally accepted, scientifically validated indicators of health.

4.4 Consider designating a sector that considers zoonotic and exotic diseases.

4.5 Include the need to develop strategies to preserve or maintain unique animal models (because of genetics or research focus), if a local, regional or national health challenge were to occur.

4.6 Monitor the animals that are included in the strategy to identify and address new issues rapidly, and set standards (e.g. in Scandinavian countries, data banks on farm animal health exist, with standards set such as ≤ 15% lameness in cattle).

The strategy should NOT address risks of a local nature that do not present risks to the general animal population, ecosystem or humans.

5. Working Group – Scope

Ensuring the well-being and welfare of the animals involved is one of the overarching principles that guide the ethical use of animals in science. The experimental animals sector may be the only sector in the NAHS where this is explicit. Managing to implement a national program for the past 40 years, the CCAC may offer a useful template for organizing other sectors into a cohesive national unit.

There is an ongoing societal debate concerning the use of animals for scientific purposes. However, because of the need to work constructively in this area, animal welfarists, both within science and without, recognize that animal researchers have a role to play as moral stewards.

To an extent, this view is believed to be based on the approach of Albert Schweitzer (1875–1965)—Nobel Peace Laureate, medical practitioner, and doctor of philosophy. (That is, to cause pain or death when it can be avoided is wrong.) In addition, it signifies the beginnings of a move toward an ecological ethic, wherein the preservation of a greater whole is seen as important, occasionally at the expense of an animal’s life. In this context, animal experimentation is viewed as a “necessary evil,” which is justifiable as long as those who conduct the experiments are in tune with their moral obligations—to society and to the animals in their care (Monamy, 2000). The CCAC position statement “Ethics of Animal Investigation,” published in 1989, expresses these concepts for the CCAC. Building on principles first outlined by Marshall Hall, it also enshrines the Three Rs into the CCAC system (http://www.ccac.ca/en/CCAC_Programs/ETCC/Module02/07.html).
This is the convergence point for 2000 scientists, veterinarians, animal care technicians, students, community representatives and animal welfare organization representatives who participate in the CCAC system of ethical review and oversight for the care and use of animals used in science in Canada since 1968.
What is key to the CCAC system is its involvement with the general public in all its activities, specifically, in

• establishing ethical standards through guideline development
• ethical decision making at the level of each institutional Animal Care Committee (ACC)—pioneered by the CCAC, structured as a microcosm of Canadian society, and is the keystone of the CCAC system, now emulated worldwide
• offering sound judgment on each CCAC assessment panel
• providing a public perspective on the CCAC Council

This integrated approach is essential to ensure that an external perspective is actively provided to all discussions and decisions on animal care and use in science, and that those who conduct the experiments are in tune with their obligations to the animals in their care, as well as to the other members of society.

The range of animals covered by the CCAC includes all vertebrates that are used in science (i.e. research, teaching, testing and production [animals and by-products, for example, pharmaceuticals]), along with a few species of invertebrates. These include animals used in a laboratory setting, as well as farm animals, companion animals and wildlife that are being used for scientific purposes, including those used for scientific purposes outside the traditional laboratory setting.

The CCAC Expert Working Group scope is broader; there is a need to consider the effects of the health status of other species on research animals—for example, the effects of chronic wasting disease on the study of wild ruminants, as well as the potential for its transfer to research herds maintained in a captive environment.

6. NAHS – Issues Specific to Animals Used for Scientific Purposes

Over the last 2 decades, a significant commitment of resources was allocated to identify replacement, reduction and refinement (Russell and Burch,1959) alternatives to animal use in research, teaching and testing. The ethical principles of humane science, through the implementation of the Three Rs, including a focus on the minimization of pain and distress, should remain as the framework within which the use of animals in science is permitted. This use is governed by CCAC guidelines and policies, as well as other relevant statutes, including provincial legislation.

The ethical framework requires a balance between the harm inflicted on individual animals, species and/or populations and the acquisition of knowledge for discovery aimed at the beneficial interests of animals, humans or the environment. The NAHS and/or any additional rules or regulations that may arise should not interfere with the legitimate use of animals in science, as overseen by the CCAC.

For this reason, the NAHS should address the following:

• National and provincial regulations and policies that incorporate CCAC standards (i.e. its policies and guidelines) to ensure that the use of animals in science is conducted under mandated standards
  
• A focus on the scientific use of animals as a means to understanding their unique physiologies, requirements, sensitivities to eventually assist in conserving and preserving species
  
• Biosecure transportation of animals, tissues and animal-based products internationally (in particular, those imported into Canada)
  
• Spontaneous diseases that occur in animals used in science that might be transferred to other animals nationally or internationally through “contamination” of animals, their tissues (e.g. organs or tissues transported to another institution for research or diagnostic purposes) or processed products (e.g. serum, polyclonal or monoclonal antibodies)
  
• National policies for the handling of wildlife in research and management
  
• Access to clean, disease-free animals for use in biomedical research, including non-livesTock animals from Canada and abroad
• A significant investment in research can easily be lost due to apparently clinically healthy animals developing disease or exhibiting a pathology, which interferes with the data. Likewise, access to tissues, cell cultures and serum products that are free of microbial pathogens is important, which could be achieved by establishing regional research centres with conventional disease-free/SPF herds available.
• Compliance with specific biosecurity requirements, including movement of animals and people; sentinel testing at regular periods; exemption from eradication strategies for specific herd(s) or animals until/unless absolutely necessary (e.g. demonstrated by blood test) – quarantine first
• Human interaction with animals used in science, ranging from controlled
• laboratory-based work to field situations
• A conservative and precautionary approach is required with the range of use to deal with potential environmental impact.
• Examination of practices that relate to antimicrobial use in research because of bacterial resistance
• Communication by the veterinarian who is working with the research animals to the vendor/farmer about health issues or pathology results (non-reportable diseases)
  This should permit the vendor/farmer to access Ministry of Agriculture resources to eliminate disease from the herd.
• Review of current practices with respect to laboratory modified/adapted/genetically modified strains of viruses used for research purposes
  
• Research funding in areas where there is a conflict of interest impacting animal health and welfare—for example, funding by individual fish farmers to develop health management practices that should be applied to the industry as a whole, rather than being subject to confidentiality and used to gain a competitive edge (recognition that animal health and welfare is a societal benefit)
  

The NAHS should NOT drill down to health issues that are directly related to the animal model itself (e.g. genetically engineered animal) and that are defined in an animal-use proTocol, approved by the institutional animal care committee. These health issues are risks to other animals, humans and/or the environment only if facilities, equipment and procedures designed to contain the animals and the infectious/toxic/radiological agents fail to do so. The NAHS should limit itself to ensuring that research facilities that use animals do so responsibly.

7. The Strategy – General Outcomes

In general, the Working Group agreed with the general outcomes proposed; however, the list has been adjusted as follows to reflect the Working Group’s discussion to date.

• Ensure a healthy environment (ecosystem), as a pre-requisite for healthy animals, including the protect ecosystem health through a variety of strategies, not limited to prudent animal health practices
• Sustain the health of animal populations by maintaining their viability and genetic diversity
• Identify and manage the factors that lead to suboptimal animal health
• Continue to improve the quality of life for animals
• Protect Canadians from animal-related health risks
• Strengthen domestic and international confidence in the integrity of Canada’s animal health, environment protection and food safety systems
• Minimize the economic, social and environmental consequences of animal diseases
• Develop an integrated governance system to mitigate animal health risks
• Develop an integrated governance system to improve and ensure animal welfare
• Implement evidence-based assessments to measure progress in all aspects of the agreed strategy.

NAHS outcomes should NOT

• limit property rights, or if they do, compensation must be provided
• lead to loss of knowledge
• lead to delays in knowledge acquisition
• contribute to the loss of historical and cultural knowledge concerning animals and their husbandry
• increase material and financial costs associated with caring for animals (e.g. farm gate returns and production costs; animal research infrastructure and operational costs, and grant funding)
• cause social and community derangements, owing to the social impacts of limitations on customary animal use
• discourage advancement of knowledge through increased regulatory burden

There is a need to determine how these intended outcomes will fit into an integrated governance system and how that will differ or complement existing regulations and laws.
A scientifically rigorous risk analysis is necessary to implement the strategy—who will be responsible for providing the instruction or carrying our analysis?

Similarly, there will need to be a good communication plan in place. To facilitate communication, a clear understanding of the terms used during NAHS development should be developed. The communication link between regions and the institutional level will be important if protection of particular animal resources at one location, but not another, is required.