Summary

Transportation of research animals is an essential component of the biomedical research enterprise that can have substantial, although often little understood, effects on the physiological and psychological condition of the animals. Both environmental conditions and the novelty of the transportation experience can cause stress, which can cause short-term changes in physiology and thus affect subsequent research if the animals are utilized immediately after transportation. In addition, transportation stress in great intensity or duration can adversely affect animals’ well-being.

Individuals at research facilities often find arranging transportation of animals a challenge. A confusing patchwork of local, national, and international regulations; a perceived lack of high-quality shipping services; a dearth of science-based good practices; and a lack of biosafety standards all represent difficulties with which people are confronted when attempting to move research animals to or from their institution.

In recognition of these challenges and the potential for transportation to affect subsequent research, the National Institutes of Health (NIH) and the National Center for Infectious Diseases asked the National Research Council to form a committee of experts to address current problems encountered in the transportation of research animals and to offer recommendations for rectifying the problems for the benefit of research animals and the research community.

Developing science-based good practices was the major focus of the committee’s efforts, which was particularly challenging given the dearth



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Summary T ransportation of research animals is an essential component of the biomedical research enterprise that can have substantial, although often little understood, effects on the physiological and psycho- logical condition of the animals. Both environmental conditions and the novelty of the transportation experience can cause stress, which can cause short-term changes in physiology and thus affect subsequent research if the animals are utilized immediately after transportation. In addition, transportation stress in great intensity or duration can adversely affect animals’ well-being. Individuals at research facilities often find arranging transportation of animals a challenge. A confusing patchwork of local, national, and inter- national regulations; a perceived lack of high-quality shipping services; a dearth of science-based good practices; and a lack of biosafety standards all represent difficulties with which people are confronted when attempt- ing to move research animals to or from their institution. In recognition of these challenges and the potential for transportation to affect subsequent research, the National Institutes of Health (NIH) and the National Center for Infectious Diseases asked the National Research Council to form a committee of experts to address current problems encountered in the transportation of research animals and to offer recom- mendations for rectifying the problems for the benefit of research animals and the research community. Developing science-based good practices was the major focus of the committee’s efforts, which was particularly challenging given the dearth 1

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2 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS of literature available on transportation practices and the effect of trans- portation on the most common research animals. However, using the extensive body of literature that is available on agricultural animals, the committee was able to develop, in Chapter 3, a set of good practices based on some universal concepts of physiology and a scientific understanding of species-specific needs and differences. Good practices were developed to address thermal environment, space requirements, food and water requirements, social interaction and group transportation, handling, monitoring of transportation, emergency procedures, and personnel train- ing. Although precise engineering standards are often preferred by human assessors, the scientific literature supports few engineering standards. Therefore, the good practices recommended by the committee were developed as “performance standards,” which define an outcome (such as animal well-being or safety) and provide criteria for assessing that out- come without limiting the methods by which to achieve that outcome. The use of performance standards allows institutions and organizations the flexibility to adjust their procedures to optimize animal welfare according to the species being transported, the mode of transportation, and local environmental conditions. During public hearings, it was evident that the issue causing the great- est confusion among those attempting to ship research animals is the over- lapping authority that multiple federal agencies have over the research animal transportation process. In Chapter 2, the committee identifies the federal agencies that may be involved in the process and summarizes their agencies’ statutory authority, the aspects of the transportation process that they regulate, and how they enforce their authority (inspection, permit- ting, and issuing standards). In addition, the committee identifies the major international treaties and agreements that may pertain to the im- portation or exportation of animals into or from the United States. At the end of the chapter is a checklist of questions that can be used to identify the standards that apply when transporting animals into, out of, or within the United States. Several of the federal statutes were enacted to prevent the introduc- tion, transmission, or spread of communicable disease in the United States, which could occur either intentionally or unintentionally through human exposure to animals. Infectious pathogens are not only a risk to public health, but can jeopardize animal health, research programs, and agricultural resources if introduced into animal colonies and laboratories. In Chapter 4, the committee identifies diseases of research animals that can be transmitted to humans, agricultural animals, and other research animals, and recommends good practices to avoid biosafety problems during transport and introduction at a new facility. Utilizing a good shipper is important for maintaining biosecurity during transport, as well

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3 SUMMARY as for ensuring the safety and comfort of the animals. The committee identifies characteristics of a good shipper (Chapter 4) and also provides a checklist of factors to consider when arranging transportation of research animals between research facilities (Chapter 1). The committee also examined the existing system for transporting research animals by truck in the United States (Appendix B). By combin- ing information on the locations where research animals are utilized and the locations of the major research animal vendors and breeders in the United States, the committee was able to construct a geographic informa- tion system model. This hypothetical model provides a qualitative sense of the patterns of transportation of research animals. In addition, this section presents the results of a quantitative modeling effort to locate additional supply points “optimally” and an assessment of the potential benefit of the additional supply points. MAJOR RECOMMENDATIONS Declining Availability of Air Transportation for Nonhuman Primates Over the last 10-15 years, most foreign and domestic airlines have implemented a ban on transporting nonhuman primates destined for research. Many factors may have contributed to this decline, including concerns about zoonoses, the high cost of training personnel and acquir- ing protective equipment, the negative reactions of airline passengers, pressure from animal rights activists, and the unprofitable nature of live- animal transportation. Currently, only one domestic airline and five foreign airlines will consistently transport nonhuman primates. In the committee’s judgment, the most promising solution for ensuring a stable means of transporting nonhuman primates into and within the United States is for NIH, through the National Center for Research Resources, to update and implement the National Primate Plan. This plan could include several different actions to be pursued, including developing national nonhuman primate resources and ensuring financial allowances for costs associated with chartering private airplane transportation. The committee also recommends that the National Primate Research Centers (NPRCs) and research institutions utilizing nonhuman primates work together to encourage the development of reliable ground transpor- tation for nonhuman primates. Although ground transport of nonhuman primates does occur, it is not widespread, possibly due to economic con- straints and because most ground transportation companies are geared toward the transportation of rodents and other small mammals. How- ever, NPRCs and researcher institutions could prepare for the possibility that domestic transportation on commercial airlines may one day become

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4 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS unavailable by partnering to encourage reliable ground transport, perhaps through professional societies. The committee also recommends that federal agencies that fund nonhuman-primate research and the commercial shipping community coordinate an initiative to develop a self-contained overshipper to ship nonhuman primates (and other animals) that pose a significant risk of zoonotic exposure. An overshipper is a closed, environmentally controlled container into which a standard primary enclosure is loaded in order to prevent a zoonotic exposure. The advantages in safety, security, and con- venience could encourage more airlines to transport nonhuman primates. In addition, with increased research focus on potential agents of bio- terrorism, an overshipper could increase the ability of the research com- munity to access or exchange established animal models of infectious and zoonotic diseases. Regulatory Burden The complex and confusing regulatory environment surrounding the transportation of research animals led the committee to recommend the establishment of an interagency working group to coordinate all federal inspection and permitting activities related to the transportation of research animals and their products. Currently five federal agencies have oversight authority on various aspects of the transportation process. The resulting overlap of authority presents a significant regulatory burden to individual researchers and commercial shipping operations. Establish- ing a working group would centralize operations and communications, and would reduce regulatory burden by minimizing the number of inspections and permits that must be issued for each shipment. The com- mittee also recommends that the various federal agencies work to clarify confusing and inconsistent regulations that pertain to transportation of research animals and their products, and in particular the Animal Welfare Act regulations, which are the federal regulations that establish standards for animal welfare that apply to most species of research animals during transportation. Animal Welfare Many issues must be considered in order to ensure the comfort, well- being, and safety of research animals during transportation. This can present a challenge to individuals at research institutions that have little previous experience with facilitating the transportation of research ani- mals. These investigators may be unfamiliar with practices that address the welfare of animals, methods that minimize transit time, and charac-

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5 SUMMARY teristics of an effective commercial shipper. Therefore, the committee recommends that research institutions, whether commercial or academic, designate a single individual to be responsible for ensuring the safe ship- ment and receipt of research animals. This individual would ensure appropriate registration and permitting, as well as the use of US Depart- ment of Agriculture-certified carriers, properly trained subcontractors, and appropriate transportation enclosures. It is expected that designation of a responsible individual will alleviate the burden on investigators of becoming familiar with the intricacies of federal regulations and resources such as commercial services, and will, most importantly, ensure the welfare of the animals involved.

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