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Transportation of Research Animals

Tue, 09/30/2008 - 11:50pm
Moshe Shalev, MSc, VMD, DACLAM

In recent years, the volume of biomedical research involving animals has increased, and along with it, the demand for the safe transportation of research animals.

Meeting the demand for the safe transportation of research animals has been made more difficult by the proliferation of a confusing and redundant regime of regulations governing animal transportation and a decline in the avail- ability of good-quality transportation services. In 2006, a committee of the Institute for Laboratory Animal Research (ILAR) of the National Research Council released a report, Guidelines for the Human Transportation of Research Animals,1 which identified the problems associated with animal transportation and proposed recommendations to address them.

The ILAR report serves as a useful guidebook for investigators aiming to adhere confusing regulations, protect the viability of their research and, most importantly, secure the comfort and well being of their animals. The ILAR committee identified four main problems in the current state of transportation for research animals. They highlighted 1) the unclear, cumbersome network of local, national, and international regulations, 2) inadequate guidelines for scientifically-sound shipping practices, 3) a lack of biosafety standards necessary to protect against the accidental or intentional introduction of infectious pathogens during animal transit and 4) “a perceived lack” of high-quality shipping services.

The committee devoted the second chapter of the report solely to outlining the various state, federal, foreign, and international agencies that oversee various aspects of animal transportation. In the United States, state health and agricultural services make rules for the movement of animals into and out of their borders. The USDA oversees the Animal Welfare Act (AWA) and its specific standards for each stage of transport (including the primary enclosure and conveyance, food and water allocation, regular and emergency care in transit, handling and receipt of shipments).2,3 The U.S. Fish and Wildlife Service requires permits for the importation, exportation, and interstate transfer of wildlife, including species covered under the Endangered Species Act,4 administers the separate permit scheme set out by the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES),5,6 and administers the Lacey Act,7 which, along with the AWA, provides for the humane care of animals during transport. The Centers for Disease Control and Prevention (CDC) operates a system of permitting, registration, and quarantine to regulate animals capable of carrying zoonotic disease. Specific offices within the CDC are responsible for the importation of nonhuman primates (CDC Division of Global Migration and Quarantine),8,9 and imports of live bats and other etiologic agents (CDC Etiologic Agent Import Permit Program).10 The Office of Hazardous Materials in the U.S. Department of Transportation11 also supervises the intra-and inter- state and international movement of poisonous, radioactive or infectious materials with the potential to cause disease in animals or humans, with special procedures for live animals. Finally, the Public Health Service (PHS) mandates self-policing performance stances for the transportation of research animals for all institutions funded by PHS.12

Along with these U.S.-based regulations, the European Union and various international treaties and agreements set standards and rules for the animal transfer. The European Union’s regulations are contained in the following articles: Council Regulation No 1/2005 of December 22, 2004 on the protection of animals during transport and related operations;13 Consumer Policy Treaty Articles 95 and 153; Public Health Treaty Articles 95, 152, and 300; Food Safety, Animal Health, Animal Welfare, and Plant Health Treaty Articles 37, 95, 152. The main international agreements and organizations of relevance to transportation of animals are CITES, the International Air Transport Association’s (IATA) Live Animals Regulations14,15 (LARs, and the World Animal Health Organization (WAHO). Individual countries also have their own rules governing the importation and exportation of animals.

Information on regulations of the European Union of transporting farm animals may be found at the section of “Animal welfare during transport” of the Food Safety site of the Europa website.16

As this rundown makes clear, the regulatory web is convoluted. The committee’s clear presentation of the various permit requirements does much to clarify the process for researchers and shippers (see especially Table 2-6). But no table, even ones as user-friendly as those contained in the report, can resolve the redundancy that plagues the regulatory regime. The desirability of streamlined and inter-agency cooperation procedures often exceeds the government bureaucracy’s capacity to produce such results. In this case, however, the usual obstacles may be more easily overcome because of pre-existing overlaps. Several agencies already base their permit and inspection procedures on the same sources. For instance, the IATA’s Live Animals Regulations (LARs) have been adopted by CITES and the WAHO, have informed the European Council’s procedures for farm animal transport and are enforced by the European Union, the U.S. Fish and Wildlife Service. According to the IATA’s website, LARs also “generally meet or exceed” the requirements of the Animal Welfare Act (AWA). Additionally, while the IATA’s regulations for the transportation of dangerous goods (such as infectious animals or animal derivates) are more restrictive than the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of Dangerous Goods by Air, 17 the IATA adopts the same classifications that the Department of Transportation’s (DOT) Office of Hazardous Materials uses to regulate the intrastate, interstate and international movement of radioactive or infections materials. Already Technical Instructions is accepted as a compliance alternative to DOT’s requirements. While this overlap currently stands as an impediment to quick and easy compliance, it offers an opportunity for cooperation, the very type the report recommends in its proposed interagency working group.

Along with the creation of a single body to oversee animal transfer review, registration, permitting, and quarantining (when necessary), the ILAR committee also recommends that each institution appoint an individual to supervise the shipment and receipt of research animals. Dr. Steven L. Leary, a member of the ILAR committee and the Assistant Vice Chancellor for Veterinary Affairs atWashington University in St. Louis, said of his institution’s implementation of (which predated the committee’s activity), “Having a single point of contact has centralised and streamlined our animal shipment process, improved communication and freed veterinary time.”18

No longer bogged down by regulatory burden, the veterinarian can focus on implementing good practices for the preparation of animals before transfer, their care in transit, and their acclimation following arrival. In that respect, the ILAR report again serves as a valuable tool to animal caregivers. The report compiles decades of research on ways to identify and minimize the physiological and psychological impact of travel on animals. While the committee’s general pronouncements reinforce obvious recommendations – transit conditions should replicate housing conditions as closely as possible, for example – such a common-sense caution is warranted. For instance, inadequate thermal conditions can prove seriously hazardous to animal health. As the report notes, temperature is “the major factor in leading to animal mortality during transportation in many species.”19 Investigators are advised to consult the report’s specific, research-based recommendations on the proper temperature range, space allocation, food and water provision, social interaction and group transportation, handling, emergency procedures, and personnel training.

Amid concerns of bioterrorism and global human and agricultural epidemics, greater attention has been paid to biosafety risk that animal transportation poses. Under the USA Patriot Act (2001),20 the Bioterrorism Preparedness and Response Act (2002),21 and the Code of Federal Regulations (42 CFR73, 7CFR331, and 9CFR121), research institutions in possession of certain toxic agents are required to register with the CDC and must adhere to a transportation plan, which includes, for example, the use of a USDA approved carrier and documented safety and security training for involved personnel).22 In order to improve safety of transporting infectious animals, the ILAR committee recommends the use of over shippers – closed devices that cover primary animal enclosures, thus limiting animal-human contact but still permitting necessary access.

Non human primates pose a special risk of transmitting zoonotic diseases and consequently are subject to greater agency oversight and require heightened protections during transfer.23 Air transfer is especially problematic. Currently, only one U.S. domestic airline and five international airlines “consistently” carry nonhuman primates (page 3 of the ILAR). Reluctance on the part of airlines to carry the animals is due in part to the difficulty of dealing with the permitting process, the need for trained personnel and protective gear, passenger and personnel discomfort, pressure from animal rights lobbyists, and the lack of profitability. The committee recommends that the National Center for Research Resources amend its National Primate Plan to increase financial resources for chartered air transportation and that the National Primate Research Centers and research institutes work together to develop ground transportation alternatives. The use of over shippers may also help alleviate the concerns of airlines.

Until ILAR’s recommendations are implemented, researchers and shippers are advised to consult its clearly presented compilation of regulatory and good practice data and to adopt its intermediary measures.

References

1. Guidelines for the Humane Transportation of Research Animals Committee on Guidelines for the Humane Transportation of Laboratory Animals, National Research Council National Academies Press. http://books.nap.edu/openbook. php?record_id=11557&page=11.
(http://www.nap.edu/catalog/11557.html). 2006.

2. Animal Welfare Act :Animal Welfare Act. United States Code. Title7–Agriculture. Chapter54– Transportation, Sale, and Handling of Certain Animals: http://www.aphis.usda.gov/animal_welfare/awa.shtml. Sec. 2143Standards and certification process for humane handling, care, treatment, and transportation of animals:
http://www.aphis.usda.gov/animal_welfare/downloads/awa/54USC2143.txt

3. Animal Welfare Regulations: Title9–Animals and Animal Products.Chapter1–Animal and Plant Health Inspection Service, Department of Agriculture. http://www.aphis.usda.gov/animal_welfare/awr.shtml

4. Endangered Species Act (ESA) of1973(16 USC§§1531-1544). http://www. fws.gov/endangered/wildlife.html# Species. Pub. L.93-205,87Stat.884,16 U.S.C. §1531-1534. http://www4.law.cornell.edu/ uscode/16/1531.html and http://www.fws.gov/r9endspp/esa.html.

5. CITES: Convention on International Trade in Endangered Species of Wild Fauna and Flora.
http://www.cites.org/eng/disc/what.shtml.

6. CITES: Guidelines for transport: http://www.cites.org/eng/resources/transport/index.shtml. Example: Mice, rats, cavies and other small mammals: http:// www.cites.org/eng/resources/transport/mm6.shtml

7. Lacey Act. Wikipedia. http://en.wikipedia.org/wiki/Lacey_Act: The Lacey Act of 1900,16 U.S.C.§3371–3378 (http://www.law.cornell.edu/uscode/16/3378.html), still in effect today, was the first federal law to protect wildlife. It has been amended several times, the most significant of which were in 1969, 1981,and in1989. The Lacey Act was enacted to prohibit the transportation of illegally captured or prohibited animals across state lines. The law is primarily used today to prevent the importation or spread of potentially dangerous non-native species.

8. Division of Global Migration and Quarantine. CDC. http://www.cdc.gov/ncidod/ dq/quarantine_stations.htm.

9. Travelling with Pets, Importation of Animals and Animal Products into the United States. CDC. http://www.cdc.gov/ncidod/dq/animal/index.htm. “CDC regulations govern the importation of dogs, cats, turtles, monkeys, other animals, and animal products capable of causing human disease. Requirements for the importation of the most common pets are described below. Pets taken out of the United States are subject upon return, to the same regulations as those entering for the first time. “The CDC does not require general certificates of health for pets for entry into the United States. However, health certificates may be required for entry into some states, or may be required by airlines for pets. You should check with officials in your state of destination and with your airline prior to your travel date. “Restrictions on the importation of non human primates, certain other animals, and certain animal products capable of causing more serious human disease are described under Restricted Animals, Agents, Hosts, and Vectors.” http://www.cdc.gov/ncidod/dq/animal/index.htm http://www.cdc.gov/ncidod/dq/animal/index.htm.”

10. Etiologic Agent Import Permit Program.CDC. http://www.cdc.gov/od/eaipp/

11 .The Office of Hazardous Materials Safety (OHM). US Department of Transportation. http://hazmat.dot.gov/hazhome.htm.“The Office of Hazardous Materials Safety (OHM) formulates issues and revises Hazardous Materials Regulations (HMR) under the Federal Hazardous Materials Transportation Law. The HMR cover hazardous materials definitions and classifications, hazard communications, shipper and carrier operations, training and security requirements, and packaging and container specifications.”

12. Public Health Service Policy on Humane Care and Use of Laboratory Animals. Office of Laboratory Animal Welfare National Institutes of Health. National Institutes of Health. http://grants1.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf
http://grants1.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf

13. Council Regulation No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/ 432/EEC and 93/119/EC and Regulation (EC) No 1255/97
http://eurlex.europa.eu/LexUriServ/site/en/oj/2005/l_003/ l_00320050105en00010044.pdf.

14. IATA Live Animals Regulations (LAR). A Worldwide Standard and an essential manual for those who need to ship animals in a safe and cost-effective manner. http://www.iata.org/ps/publications/ lar.htm.

15. Dangerous Goods & Safety Worldwide: The IATA 'DG Center of Expertise' strives to lead industry efforts to ensure the safe handling of dangerous goods in air transport, by providing a broad array of technical knowledge, products, services and training solutions tailored to meet industry needs.
http://www.iata.org/whatwedo/cargo/dangerous _goods/index.htm.

16. Animal Welfare during transport: Food Safety –from the farm to the fork. Eorupa.
http://ec.europa.eu/food/animal/welfare/transport/index_en.htm.

17. Technical instructions for the save transport of dangerous goods by air. ICAO Document 9284. http://www.icao.int/icaonet/dcs/9284.html.

18. http://www.izs.it/vet_italiana/2008/133_ 139.pdf

19. ILAR report page 39. This sentence cites Abbott et al., 1995; e.g., Bayliss and Hinton, 1990; Slanetz et al., 1957.

20. USA Patriot Act of 2001. http://thomas.loc.gov/cgi-bin/query/z?c107:HR3162ENR.

21. The Bioterrorism Act of 2002. http://www.fda.gov/oc/bioterrorism/Bioact.html. The events of Sept. 11, 2001, reinforced the need to enhance the security of the United States. Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which President Bush signed into law June 12, 2002.

22. Page 66 of ILAR report.

23. National Research Council (NRC). 2003b. Occupational Health and Safety in the Care and Use of Non human Primates. Washington, DC: The National Academies Press.
http://books.nap.edu/openbook.php?record_id =10713&page=147

Veterinarian Moshe Shalev, MSc (Genetics), VMD, is a Diplomate of the American College of Laboratory Animal Medicine. A recognized expert in medicine, management, and facility designs of small, farm, and exotic laboratory animals, he publishes regularly on animal welfare regulations. Dr. Shalev may be reached at editors@alnmag.com.

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