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Regulations and Guidelines for the Transportation of Research Animals

The purposes of this chapter are to identify national and international agencies responsible for the safe, humane, and expeditious transportation of live research animals and biological materials (tissues and specimens) derived from animals, to summarize and review regulations governing their transportation, and to identify overlaps and gaps among regulations and agency responsibilities insofar as they represent strengths and impediments (see Table 2-1). The first section of the chapter focuses on national and the second on international transportation regulatory agencies, their responsibilities and their regulations. Although the committee has attempted to provide a comprehensive summary of transportation regulations and requirements (see Table 2-6 at end of chapter), the shipper is advised to check with the appropriate agencies prior to shipment to ensure compliance with current regulations and requirements.

NATIONAL REGULATIONS AND GUIDELINES

Several federal agencies in the United States regulate the transport of research animals and their tissues specifically or of species that might be used for research. The agencies are vested with authority under various federal statutes. In this section, the regulations and guidelines to inform readers unfamiliar with the web of regulations are discussed. All of the regulations and guidelines are applicable to the transportation of research animals, but only two laws identify standards for humane care during



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2 Regulations and Guidelines for the Transportation of Research Animals T he purposes of this chapter are to identify national and inter- national agencies responsible for the safe, humane, and expeditious transportation of live research animals and biological materials (tissues and specimens) derived from animals, to summarize and review regulations governing their transportation, and to identify overlaps and gaps among regulations and agency responsibilities insofar as they repre- sent strengths and impediments (see Table 2-1). The first section of the chapter focuses on national and the second on international transportation regulatory agencies, their responsibilities and their regulations. Although the committee has attempted to provide a comprehensive summary of transportation regulations and requirements (see Table 2-6 at end of chapter), the shipper is advised to check with the appropriate agencies prior to shipment to ensure compliance with current regulations and requirements. NATIONAL REGULATIONS AND GUIDELINES Several federal agencies in the United States regulate the transport of research animals and their tissues specifically or of species that might be used for research. The agencies are vested with authority under various federal statutes. In this section, the regulations and guidelines to inform readers unfamiliar with the web of regulations are discussed. All of the regulations and guidelines are applicable to the transportation of research animals, but only two laws identify standards for humane care during 11

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12 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS TABLE 2-1 Federal Statutes/Programs Relevant to the Transportation of Vertebrate Research Animals and Products in the United Statesa Nonhuman Primates Cats and Dogs Agency Agency Program or Federal Regulation Interstate Import/export Interstate Import/export Animal Welfare Act X X X X USDA ++ CITES X FWS Lacey Act X X Endangered Species Act X X Division on Global Migration and Quarantine (DGMQ) X* X* CDC Etiologic Agent Import Permit Program (EAIPP) Infectious Substances Program DOT Radioactive/Poisonous Materials Program 42 CFR 70.2 and 21 CFR 1240.30 FDA a Multiple columns may be applicable to a single shipment of animals or animal products. * Regulates importation only. ** Regulates importation and interstate transportation only. *** Regulates interstate transportation only. + Animals that are known to harbor a human pathogen fall under the purview of DGMQ. Animals with human pathogens fall under the purview of EAIPP only when they are experimentally infected. ++ Wild-domestic hybrids, such as leopard cats, may be considered wildlife under CITES. +++ EAIPP regulates the importation and interstate transportation of all bats, regardless of disease status.

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13 Animal Products Containing X Radioactive/Poisonous Material (Interstate, Import, Export) Live Animals Containing Radioactive/Poisonous Material X (Interstate, Import, Export) Animal Products with X** Zoonotic/Infectious Diseases X REGULATIONS AND GUIDELINES FOR TRANSPORTATION (Interstate, Import, Export) Live Animals with X**,+ X*** X*,+ X Zoonotic/Infectious Diseases (Interstate, Import, Export) Endangered/Threatened Wildlife X X X X (or products thereof) (Interstate, Import, Export) Wildlife (or products of wildlife) X X (Interstate, Import, Export) All Other Warm-blooded Vertebrates +++ X (Interstate, Import, Export) Rats of genus Rattus, Mice of genus Mus, and Birds (Interstate, Import, Export)

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14 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS transportation: the Animal Welfare Act (AWA), which details specific standards for animal care during transportation, and the Lacey Act, which provides that wildlife be transported in accordance with the International Air Transport Association (IATA) Live Animals Regulations (LARs). DEPARTMENT OF AGRICULTURE The AWA provides standards for the humane handling, care, treat- ment, and transportation of animals (AWA, 7 USC 2131 et seq.). AWA regulatory authority is vested in the Secretary of Agriculture and imple- mented by the US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS). With the exception of rats of the genus Rattus and mice of the genus Mus, bred specifically for research purposes, as well as all birds, and livestock or poultry used for improving animal nutrition, breeding, management, production efficiency, or food or fiber quality, the AWA regulates the transportation of all warm-blooded animals intended for use in research, teaching, or testing (9 CFR 1.1). That regula- tion applies to transportation of AWA-covered species within the United States, as well as their transportation on foreign air carriers traveling into, within, or from the United States, its territories or possessions, or the District of Columbia (Federal Register, Vol 69, No 66, pages 17899–17901). With regard to the transportation of animals, the act contains stan- dards for consignment (delivery of animals to an entity for transport), primary transportation enclosure, primary conveyance, food and water- ing requirements during transportation, terminal facilities, care in transit, and handling. The AWA contains standards for different groups of similar species, with separate rules for transporting dogs and cats, guinea pigs and hamsters, rabbits, nonhuman primates, marine mammals, and all other covered warm-blooded animals. The AWA standards are rather extensive and pertain directly to animal welfare. They are summarized in Appendix B for ease of use. US FISH AND WILDLIFE SERVICE The US Fish and Wildlife Service (FWS) regulates the importation, exportation, and interstate trade of dead and live wild animals and their tissues and products imported into or exported1 from the United States 1Wildlife (including parts and products) that are in transit through the United States from one foreign country to another foreign country are exempt provided that the wildlife stays in the United States only for the time needed to transfer the specimen to the mode of trans- portation used to continue to the final destination and remain under control of Customs and Border Protection. Wildlife that is listed as injurious (Part 16), endangered or threatened

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15 REGULATIONS AND GUIDELINES FOR TRANSPORTATION for any purpose (including research). Wildlife means any wild animal, whether alive or dead, including any wild mammal, bird, reptile, amphibian, fish, mollusk (clam, snail, squid, or octopus), crustacean (crab, lobster, or crayfish), insect, sponges, corals, or other invertebrate, whether or not bred, hatched, or born in captivity and including any part, product (including manufactured products and processed food products), egg, or offspring thereof. The FWS authority to regulate wildlife stems from the Fish and Wild- life Act of 1956 (16 USC §§ 742a-754j-2). All wildlife being imported into or exported from the United States must be declared to FWS through completion of Form 3-177 at the time of entry or exportation and is subject to inspection. Wildlife being transported through the United States to a final international destination does not require declaration to FWS, unless it is listed as an injurious (50 CFR 16), endangered, or threatened species (50 CFR 17 and 50 CFR 222-224); a marine mammal (50 CFR 18 and 50 CFR 216); a migratory bird (50 CFR 21); or a bald or golden eagle (50 CFR 22). FWS requires that all wildlife be imported and exported through a series of designated ports. As shown in Table 2-2, some port locations are designated to allow the importation or exportation of any wildlife, and others are restricted to allow only particular species of wildlife. Endangered Species Act The purpose of the Endangered Species Act (ESA) of 1973 (16 USC §§ 1531-1544) is to conserve and recover species of fish, wildlife, and plants that are listed as threatened or endangered in the United States or else- where and to preserve the ecosystems upon which these species depend (ESA Section 2(b)). Criminal and civil penalties are designated under the ESA for violations. Nonhuman-primate species listed under the ESA are detailed in Table 2-3. Other species that are currently listed as endangered or threatened under the ESA can be found on line at: http://www.fws.gov/endangered/wildlife.html#Species FWS regulates species listed as endangered and threatened under the ESA through a system of permits. The permits are required to use these species for scientific purposes, to operate a captive-breeding program, and to transport these species through importation, exportation, or interstate species (Parts 17 and 222-224), marine mammal (Parts 18, 216), migratory bird (Part 21), or a bald or golden eagle (Part 22) and is moving through the United States is considered an import and cannot be treated as in transit.

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16 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS TABLE 2-2 Designated Port for Importation or Exportation of Wildlife or Derivatives Ports Designated for Ports Designated for Wildlife Originating in Ports Designated for Endangered or Canada or the Wildlife Originating in Threatened Species United States Mexico Anchorage, AK Alcan, AK Brownsville, TX Atlanta, GA Blaine, WA Calexico, CA Baltimore, MD Buffalo, NY El Paso, TX Boston, MA Calais, ME Laredo, TX Chicago, IL Champlain, NY Lukeville, AZ Dallas-Fort Worth, TX Cleveland, OH Nogales, AZ Houston, TX Derby Line, VT San Diego, CA Honolulu, HI Detroit, MI Los Angeles, CA Dunseith, ND Louisville, KY Eastport, ID Ports Designated for Memphis, TN Grand Portage, MN Import/Export of Miami, FL Highgate Springs, VT Wildlife from Alaska Newark, NJ Houlton, ME New Orleans, LA International Falls, MN Alcan, AK New York, NY Jackman, ME Fairbanks, AK Portland, OR Minneapolis-St. Paul, MN Juneau, AK San Francisco, CA Pembina, ND Seattle, WA Portal, ND Port Huron, MI Raymond, MT Sault Sainte Marie, MI Sumas, WA Sweetgrass, MT trade. The various permit application forms are too numerous to describe here, but are listed in detail at the FWS Permit Website: http://www.fws.gov/permit The ESA also establishes FWS as the entity responsible for adminis- tering the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) (50 CFR 23). FWS also administers CITES through a permit system, which is discussed in detail in the next section. It is important to recognize that in some instances, a single FWS applica- tion is used to obtain both an ESA and CITES permits, though not all species listed under ESA are CITES-listed species and vice versa. Applica- tions generally require 60-90 days for processing.

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17 REGULATIONS AND GUIDELINES FOR TRANSPORTATION TABLE 2-3 Endangered Species Act Listed Species of Nonhuman Primates Nasalis concolor (Pagi Island langur) Endangered Allocebus spp. (hairy-eared dwarf lemurs) Nasalis larvatus (proboscis monkey) Alouatta palliate (mantled howler monkey) Pan paniscus (pygmy chimpanzee—wild) Ateles geoffroyi frontatus (Central American Pan troglodytes (wild chimpanzee) spider monkey) Phaner spp. (fork-marked lemurs) Ateles geoffroyl panamensis (Central Planigale ingrami subtilissima (little planigale) American spider monkey) Pongo pygmaeus (orangutan) Avahi spp. (Avahi, woolly lemurs) Procolobus pennantii kirki (Zanzibar red Brachyteles arachnoids (woolly spider monkey) colobus monkey) Bradypus torquatus (Brazilian three-toed Procolobus preussi (Preuss’ red colobus sloth) monkey) Cacajao spp. (uakaris) Procolobus rufomitratus (Tana River red Callimico goeldii (Goeldi’s marmoset) colobus monkey) Callithrix aurita (buffy tufted-ear, white- Propithecus spp. (sifakas) eared marmoset) Pygathrix nemaeus (douc langur) Callithrix flaviceps (buff-headed marmoset) Rhinopithecus avunculus (Tonkin snub-nosed Cercocebus galeritus galeritus (Tana River monkey) mangabey) Rhinopithecus bieti (Yunnan snub-nosed Cercocebus torquatus (white-collared monkey) mangabey) Rhinopithecus brelichi (guizhou snub-nosed Cercopithecus Diana (Diana monkey) monkey) Cercopithecus erythrogaster (red-bellied Rhinopithecus roxellana (Sichuan snub-nosed monkey) monkey) Cercopithecus erythrotis (red-eared nose- Saguinus bicolor (pied tamarin) spotted monkey) Saguinus oedipus (cotton-top marmoset) Cercopithecus lhoesti (L’hoest’s monkey) Saimiri oerstedii (red-backed squirrel monkey) Cheirogaleus spp. (dwarf lemurs) Semnopithecus entellus (gray, Hanuman Chiropotes albinasus (white-nosed saki) langur) Chiropotes satanas satanas (southern bearded Tamarin, white-footed saki) Trachypithecus francoisi (Francois’ langur) Colobus satanas (black colobus monkey) Trachypithecus geei (golden langur) Daubentonia madagascariensis (Aye-aye) Trachypithecus pileata (capped langurs) Gorilla gorilla (gorilla) Varecia spp. (ruffed lemur, variegated Hapalemur spp. (bamboo lemurs and gentle lemurs) lemurs) Hylobates spp. (including Nomascus) Threatened (gibbons) Alouatta pigra (black howler monkey) Indri spp. (indri) Macaca arctoides (stump-tailed macaque) Lagothrix flavicauda (yellow-tailed woolly Macaca cyclopis (Formosan rock macaque) monkey) Macaca fuscata (Japanese macaque) Lemur spp. (ring-tailed lemurs) Macaca sinica (Toque macaque) Leontopithecus spp. (golden-rumped tamarin) Nycticebus pygmaeus (lesser slow lorise) Lepilemur spp. (sportive lemurs) Pan troglodytes (chimpanzees—captive) Macaca silenus (lion-tailed macaque) Presbytis potenziani (long-tailed langur) Mandrillus leucophaeus (drill) Presbytis senex (purple-faced langur) Mandrillus sphinx (mandrill) Saguinus leucopus (white footed tamarin) Microcebus spp. (mouse lemurs) Tarsius syrichta (Philippine tarsier) Monkey, black howler Theropithecus gelada (gelada baboon)

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18 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS Lacey Act The FWS is also vested with federal regulatory authority from the Lacey Act of 1900 (18 USC 42). The Lacey Act is the oldest federal wildlife protection law in the United States and prohibits inhumane and unhealthful transportation conditions for any animal defined as “wildlife” (see above for definition). The regulations for transportation under the act (found in 50 CFR 14.101-14.172, which are specific for mammals and birds) are similar to the IATA-LARs. The Lacey Act also applies the guidelines pro- vided in the LARs to nonairline methods of transportation (Kreger and Farris, 2003). CENTERS FOR DISEASE CONTROL AND PREVENTION The Centers for Disease Control and Prevention (CDC) is a compo- nent of the US Department of Health and Human Services and enforces regulations to prevent the introduction, transmission, or spread of com- municable diseases in the United States. CDC regulates the importation of any animal or animal product capable of carrying a zoonotic disease. CDC regulates importation through permitting, registration, and quarantine; it does not regulate the welfare or care of the animals. Importation of Live Animals CDC regulates the importation of dogs, cats, turtles, nonhuman pri- mates, and other animals. Dogs and cats are subject to inspection by CDC at the port of entry. Dogs must be accompanied by proof of vaccination against rabies at least 30 days before entry into the United States unless they were in areas considered rabies-free for at least 6 months before importation. Importation of dogs or cats into the United States does not require a permit or other paperwork from CDC. Dogs too young to be vaccinated or without a current rabies vaccination may be admitted into the United States if the owner signs a confinement agreement (Form 75.37), which can be accessed from the following website: http://www.cdc.gov/ncidod/dq/animal.htm To prevent infection of members of the public with Salmonella and Arizona bacteria, shipments containing more than six turtles with a carapace length of less than 4 in. or viable turtle eggs generally cannot be imported into the United States (42 CFR 71.52). However, shipments con- taining more than six turtles with a carapace length of less than 4 in. or viable turtle eggs or any combination of turtles and turtle eggs may be

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19 REGULATIONS AND GUIDELINES FOR TRANSPORTATION imported into the United States for bona fide scientific, educational pur- poses, or for exhibition when accompanied by a permit issued by CDC, Division of Global Migration and Quarantine (DGMQ) (42 CFR 71.52(c)(2)). CDC may also implement prohibitions on the importation of animals when new health risks to humans arise. As of June 2003, CDC had prohib- ited the importation of all African rodents into the United States because of concerns about monkeypox (42 CFR Part 71.56). In January 2004, CDC prohibited the importation of civets because of concerns about severe acute respiratory syndrome (CDC, 2004). However, importation of those animals for scientific, exhibition, or educational purposes is allowed with written permission from CDC (42 CFR 71.56; CDC, 2004). Since February 2004, CDC has prohibited the importation of Asian birds from selected countries due to highly pathogenic avian influenza A (H5N1). For more information about obtaining a permit or permission to import turtles, African rodents, or other prohibited animals, contact the CDC DGMQ at 404-498-1670 or online at: http://www.cdc.gov/ncidod/dq/nonhuman.htm Monkeys and other nonhuman primates cannot be imported as pets, but importation for scientific research, exhibition, or education is per- mitted. Under the Federal Quarantine Regulations (42 CFR 71.53), people importing nonhuman primates for research purposes must register with the CDC DGMQ and must • Certify that imported nonhuman primates will be used only for bona fide science, education, or exhibition; • Implement disease control measures to minimize human exposure to the animals during transportation, isolation, and quarantine; • Isolate each shipment of nonhuman primates for 31 days, monitor the animals for illness, test for tuberculosis, maintain records regarding illness and death, and test for filovirus infection in shipments where illness or death occurs during the quarantine period; • Report suspected zoonotic illness to CDC; and, • Maintain records regarding the distribution of each shipment (NRC, 2003a). Before registration and periodically thereafter, the CDC DGMQ inspects importer facilities and reviews their operations, including assess- ing transportation and disease-control measures and reviewing animal health records. For each shipment of nonhuman primates into the United States, CDC must review proposed plans for each shipment and monitor the handling of arriving shipments at the port of entry and at the quarantine facility (NRC, 2003a). To receive information on the importation of non-

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20 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS human primates and to register as an importer of nonhuman primates, con- tact the CDC DGMQ, whose phone number and website are provided above. Importation and Transportation of Etiologic Agents The CDC Etiologic Agent Import Permit Program regulates the impor- tation and subsequent transfer within the United States of live bats, as well as animals, insects, or animal tissues that contain etiologic agents. Etiologic agents are defined by CDC as a viable microorganism or its toxin which causes, or may cause, human disease; however, CDC does not spe- cifically identify the microorganisms, viruses, or prions that it considers etiologic agents. Contact information and permit applications for importation of etiologic agents or live bats (Office of Management and Budget form 0920- 0199) are available at: http://www.cdc.gov/od/ohs/biosfty/imprtper.htm US DEPARTMENT OF TRANSPORTATION The US Department of Transportation (DOT), Pipeline and Hazard- ous Materials Safety Administration (PHMSA), Office of Hazardous Materials establishes regulations to govern the transportation of hazardous materials in interstate, intrastate, and foreign commerce under the Hazard- ous Materials Regulations (HMR; 49 CFR 171-180). Hazardous materials include materials that are poisonous, radioactive, and infectious—all of which may be contained in animals or animal products that may be trans- ported in the course of biomedical research. An infectious substance is defined by DOT as a material known to contain or suspected of contain- ing a pathogen, including a virus, microorganism, or prion that has the potential to cause disease in humans or animals. Live animals that contain an infectious substance are required to be transported under terms and conditions approved by PHMSA’s Associate Administrator for Hazard- ous Materials Safety. The HMR cover five areas of shipper responsibility: • Determining the hazard class(es) of the material offered for trans- portation; • Communicating the hazard(s) using shipping papers, labels, markings, placards, and emergency-response information, as required; • Packaging requirements; • Operational rules, including for transportation by air; and, • Training and security.

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21 REGULATIONS AND GUIDELINES FOR TRANSPORTATION The majority of these tasks are performed by the shipper. The carrier must also ensure that the materials received comply with and are trans- ported in accordance with the HMR. The HMR also require people or institutions that are shipping certain types or amounts of hazardous materials, such as materials extremely toxic by inhalation, to register annually with DOT (49 CFR 107.601). There are many exceptions, as some materials and situations that are common in biomedical research are not subject to the requirements of the HMR. The exceptions are too numerous to describe here, but persons interested in shipping hazardous materials, including infectious, poison- ous, or radioactive animal products or live infectious animals, should con- tact PHMSA’s Hazardous Materials Information Center to determine whether shipment would be subject to the requirements of the HMR or visit their website online at: http://hazmat.dot.gov/ PUBLIC HEALTH SERVICE Institutions that are funded by Public Health Service (PHS) funds are subject to the PHS Policy on the Humane Care and Use of Laboratory Animals (commonly referred to as the PHS Policy). Under the Health Research Extension Act of 1985, the PHS Policy mandates adherence to the guidelines in the Guide for the Care and Use of Laboratory Animals (the Guide) (NRC, 1996). The Guide provides performance standards on the transportation of research animals. It states that all transportation of ani- mals should be planned to minimize transit time and the risk of zoonoses, protect against environmental extremes, avoid overcrowding, provide food and water when indicated, and protect against physical trauma. The PHS Policy does not provide for regular inspections. Rather, institutions are expected to police themselves in order to ensure compli- ance with the principles of the PHS Policy and the Guide. The National Institutes of Health Office of Laboratory Animal Welfare will conduct investigations when it receives complaints. FOOD AND DRUG ADMINISTRATION Under 42 CFR 70.2 and 21 CFR 1240.30, authority is given to the com- missioner of the Food and Drug Administration (FDA) to take actions believed “reasonably necessary to prevent” the spread of communicable disease when state and local actions are inadequate. By that authority, FDA prohibits the intrastate and interstate transportation—for the pur- poses of commerce, sale, or any other type of commercial or public distri-

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22 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS bution—of psittacine birds, molluscan shellfish, turtles, and African rodents or other animals that may carry the monkeypox virus (refer to 21 CFR 1240.65, 21 CFR 1240.60, 21 CFR 1240.62, 21 CFR 1240.63, respec- tively). Essentially, CDC prohibits the importation of the animals, and FDA prohibits their domestic interstate and intrastate movement, with special procedures for exceptional circumstances. Exceptions to the prohibitions are possible only by obtaining written permission from the FDA. A written request must be sent to the Listed Animal Permit Official at the FDA Center for Veterinary Medicine. The request must include the reasons why an exemption is needed and a description of the animals involved, how the animals will be transported, holding facilities, quarantine procedures, and veterinarian evaluation of the transportation. For more information, visit the following website: http://www.fda.gov/cvm/ STATE HEALTH AND AGRICULTURAL REGULATIONS All states have regulations that control the movement of animals into them, although not all of these regulations pertain to research animals. For example, the California Department of Health Services requires a per- mit to transport nonhuman primates into the state. Links to the regula- tions have been organized by the USDA APHIS Veterinary Services at: http://www.aphis.usda.gov/vs/sregs/ State regulations that pertain specifically to wildlife are found at: http://offices.fws.gov/statelinks.html The committee recommends that people arranging transportation of research animals consult those websites, particularly when arranging for transportation of animals between research institutions. INTERNATIONAL REGULATIONS FOR TRANSPORTING RESEARCH ANIMALS Regulations pertaining to the international transportation of live animals, tissues, and specimens are intended to ensure the comfort of ani- mals and the safety of animals and their handlers, and to minimize the biosecurity risks associated with the handling of live animals and of the colonies into which live animals are introduced. The international regula-

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23 REGULATIONS AND GUIDELINES FOR TRANSPORTATION tory system is a patchwork of agreements and agencies that govern the following: • Pest control and biosecurity; • Research animals; • Agriculture; • Conservation of endangered species; and, • Animals used in exhibits or events (shows or sports). Because several agencies share responsibility for enforcing inter- national transportation statutes and most countries have importation requirements, the regulatory climate is often complicated. The following is a discussion of the international treaties, agencies, or laws that provide regulation or guidance on the transportation of research animals. With the exception of CITES, enforced in 169 countries, each country has its own system of laws and guidance that may or may not draw on the treaties and laws discussed here. The Air Cargo Tariff book, published by the International Air Transport Association, is a source of information on international documentation and import requirements, though one should be aware that the information can change rapidly and requirements may be specific to a province or region. The committee suggests that the person(s) or institution(s) importing animals into the United States or exporting animals from the United States contact the consulate or website of the foreign country to determine which treaties the country enforces and the specific requirements for complying with local laws. In some cases, negotiations are necessary to address incompatibilities between US export and foreign import requirements. An export broker may be useful in assisting a shipper in fulfilling foreign importation requirements. CITES CITES, also called the Washington Convention, establishes a permit system for regulating the trade of plants and animals threatened by extinction and those that may be threatened by extinction if trade of that species is not controlled. In this context, trade refers to movement of a specimen across international borders for any purpose and includes com- mercial and noncommercial trade. It includes the importation, exporta- tion, or re-exportation (exportation of a specimen that was imported) of live and dead plants and animals or parts or derivatives of them. At the time of publication, some 169 nations are parties to CITES. In the United States, the ESA of 1973 implements the international CITES treaty (50 CFR 23). FWS administers both the ESA and the CITES treaty and therefore is

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24 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS the authority responsible for issuing importation and exportation permits in the United States. Under CITES, animals covered by the treaty are listed in three appendixes: • Appendix I lists species threatened with extinction. Trade in specimens of those species is permitted only in exceptional circumstances; commercial trade is prohibited. • Appendix II lists species not necessarily threatened with extinc- tion but in which trade must be controlled to avoid use incompatible with their survival. • Appendix III lists species that are protected in at least one country that the animal is native to and that has asked other CITES parties for assistance in controlling the trade. A database listing all of the CITES-listed species has been established. It can be accessed online at: http://www.cites.org/eng/resources/species.html The permitting requirements pertaining to the transportation of Appendix I, II, and III specimens are summarized in Table 2-4. In addition to requiring specific permits, CITES, under Resolution 10.21, endorses the IATA LARs for air and surface transportation. CITES-listed species can be imported or exported only through the following designated ports in the United States: Anchorage, AK Louisville, KY Atlanta, GA Memphis, TN Baltimore, MD Miami, FL Boston, MA Newark, NJ Chicago, IL New Orleans, LA Dallas-Fort Worth, TX New York, NY Honolulu, HI Portland, OR Houston, TX San Francisco, CA Los Angeles, CA Seattle, WA Nonhuman primates are the group of CITES species most commonly used in biomedical research in the United States. As shown in Table 2-5, wild-caught species of nonhuman primates are in both Appendix I and Appendix II. However, animals in Appendix I that are bred in captivity for commercial purposes at a facility registered with the CITES secretariat

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25 REGULATIONS AND GUIDELINES FOR TRANSPORTATION TABLE 2-4 Permitting Requirements Under CITES Appendix I Appendix II Appendix III Importation and exportation Exportation permit Exportation permit required permits required required if exporting only if exporting from the from any country nation that listed the species Permits are limited to in Appendix III specimens that will be used in scientific research, education, or conservation are considered Appendix II specimens for the purposes of permitting (CITES Article VII.4). Furthermore, where a management authority of the state of export is satisfied that an animal was bred in captivity, a certifi- cate by that management authority stating that the animal was bred in captivity may be accepted in lieu of any other required permits or certifi- cates (CITES Article VII.5). This exemption also pertains to tissues derived from a captive-bred animal. However, the term ‘bred in captivity’ only applies when the animals in question are of a second or subsequent gen- eration bred in captivity and there has been no introduction of specimens from the wild into the breeding population except to prevent or alleviate deleterious inbreeding (CITES Resolution Conf. 10.16-revised). As noted in Chapter 1, nonhuman primates are regularly imported into the United States for research purposes. Practically speaking, this means that, with rare exception, nonhuman primates bred for research in the United States cannot attain the designation of ‘bred in captivity.’ INTERNATIONAL CIVIL AVIATION ORGANIZATION The International Civil Aviation Organization (ICAO), an agency of the United Nations, publishes Technical Instructions for the Safe Transport of Dangerous Goods by Air biannually (currently the 2005-2006 edition). The Technical Instructions expand on the broad provisions governing the inter- national transportation of dangerous goods by aircraft, which are in Annex 18 to the Convention on International Civil Aviation and are based on the United Nations recommendations for the Transport of Dangerous Goods. The Technical Instructions contain the detailed regulations neces- sary for the safe transportation of dangerous goods by aircraft and are for use by all parties involved in the transportation chain, such as shippers, carriers, and country authorities. They are recognized by the US DOT as an alternative to complying with the HMR.

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26 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS TABLE 2-5 CITES Listed Species of Nonhuman Primates Appendix I Appendix II Alouatta coibensis (Coiba Island howler monkey) All primate species Alouatta palliate (mantled howler monkey) not listed in Alouatta pigra (Mexican black howler monkey) Appendix I Ateles geoffroyi frontatus (black-foreheaded spider monkey) Ateles geoffroyi panamensis (Panamanian red spider monkey) Brachyteles arachnoids (woolly spider monkey, southern muriqui) Cacajao spp. (uakaris) Callimico goeldii (Goeldi’s marmoset) Callithrix aurita (buffy tufted-ear marmoset) Callithrix flaviceps (buffy-headed marmoset) Cercocebus galeritus galeritus (tana crested mangabey) Cercopithecus Diana (Diana monkey) Cheirogaleida spp. (dwarf, lemurs) Chiropotes albinasus (white-nosed bearded saki) Daubentonia madagascariensis (aye-aye) Gorilla gorilla (gorilla) Hylobatidae spp. (gibbons) Indridae spp. (indrises, woolly lemurs, avahs, sifakas) Lagothrix flavicauda (yellow-tailed woolly monkey) Lemuridae spp. (large lemurs) Leontopithecus spp. (lion tamarins) Macaca silenus (lion-tailed macaque) Mandrillus leucophaeus (drill) Mandrillus sphinx (mandrill) Nasalis concolor (pig-tailed langur) Nasalis larvatus (proboscis monkey) Pan spp. (chipanzees) Pongo pygmaeus (orangutan) Presbytis potenziani (Mentawai Island leaf-monkey) Procolobus pennantii kirkii (Kirk’s red colobus) Procolobus rufomitratus (tana river red colobus) Pygathrix spp. (snub-nosed monkeys, douc langurs) Saguinus bicolor (Brazilian bare-faced tamarin) Saguinus geoffroyi (Geoffroy’s tamarin) Saguinus leucopus (white-footed tamarin) Saguinus oedipus (cotton-top tamarin) Saimiri oerstedii (Central American squirrel monkey) Semnopithecus entellus (hanuman langur) Trachypithecus geei (golden langur) Trachypithecus pileatus (capped langur)

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27 REGULATIONS AND GUIDELINES FOR TRANSPORTATION INTERNATIONAL AIR TRANSPORT ASSOCIATION The mission of the IATA is to “represent, lead, and serve the airline industry.” IATA is also a collective link between third parties and the airline industry. Working standards for the aviation industry are devel- oped within IATA to foster safe and efficient air transportation and to serve the stated policies of most of the world’s governments. Live Animals Regulations The LARs are applicable to air transportation companies that are members of IATA. Persons or organizations that ship live animals by IATA-member airlines, whether as cargo or as baggage, must comply with the LARs in their entirety. The IATA LARs, updated yearly, were adopted by CITES and the World Animal Health Organization (described below) as the guidelines for transportation of animals by air. Those regulations have been used by the Council of Europe as a basis for its code of conduct for the international transportation of farm animals. The European Union has adopted the LARs as the minimal standards for transporting animals in containers, pens, and stalls. The regulations are intended to prevent harm to these receptacles and to handling personnel when animals are being trans- ported. Furthermore, they act to meet flight safety requirements for the benefit of the traveling public, the crew, and the airplane. The LARs consist of government regulations and specific variations filed by such agencies as USDA and FWS. For example, US variations USG-01 through USG-20 belong to USDA and contain more restrictive guidance than is required by the AWA. Similarly, USG-21 through USG-40 is issued by FWS. For more information about the IATA LARs, go online at: http://www.iata.org/ps/publications/9105.htm Dangerous Goods Regulations The IATA Dangerous Goods Regulations (DGRs) are similar to the ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air. However, the DGRs include additional requirements that are more restrictive than the Technical Instructions, to reflect industry standard practices or operational considerations. Dangerous goods are defined as goods that meet the classification criteria of one or more of nine United Nations hazard classes. These hazard classes are identical to those used by the US DOT’s Office of Hazardous Materials Standards, Pipeline and Hazardous Materials Safety

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28 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS Administration, and include toxic, infectious, and radioactive animal tis- sues, and live infectious animals. The DGRs do not have official standing under the US DOT’s HMR. For more information on the IATA DGRs, go online at: http://www.iata.org/whatwedo/dangerous_goods1 WORLD ANIMAL HEALTH ORGANIZATION The primary functions of the World Animal Health Organization, also known as the Office International des Épizooties (OIE), are preventing and raising awareness of zoonoses worldwide. OIE was created in Janu- ary 1995 as part of the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), which aims to harmonize animal health standards and thus reduce their dampening effect on international trade. The main goals of the OIE are: • To ensure transparency in the global animal disease and zoonosis situation; • To collect, analyze, and disseminate scientific veterinary information; • To provide expertise and encourage international solidarity in the control of animal diseases; • Within its mandate under the WTO SPS Agreement, to safeguard world trade by publishing health standards for international trade in animals and animal products; • To improve the legal framework and resources of national veteri- nary services; and • To provide a better guarantee of the safety of food of animal origin and to promote animal welfare through a science-based approach. Among other tasks, the SPS Agreement charges OIE with developing international standards, guidelines, and recommendations for protecting animal health and preventing zoonoses. To that end, OIE has developed the Terrestrial Animal Health Code and the Aquatic Animal Health Code, which provide OIE member countries with standards, guidelines, and detailed recommendations for establishing their own regulations regarding the importation of animals, animal genetic material, and animal products. OIE is also responsible for improving systems by which information on animal health is gathered and analyzed on a global basis. OIE manages the world animal health information system, which uses data submitted by member countries to help identify the diseases, including zoonoses, that present the most serious threats to animal and human health world- wide. During the recent outbreak of avian influenza in Asia, OIE played a

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29 REGULATIONS AND GUIDELINES FOR TRANSPORTATION crucial role in alerting countries of the outbreak and recommending courses of action. As a result of OIE’s activities, many countries tempo- rarily halted importation from the affected areas. Several years after OIE’s founding, its member countries decided to give animal welfare high priority and to include it in their 2001-2005 stra- tegic plan. Although OIE had not been specifically mandated by the WTO SPS to protect animal welfare, the OIE’s status as the international author- ity on animal health and zoonoses and the member countries’ strong need for guidelines to assist them in conducting bilateral negotiations led the member countries to the conclusion that OIE should provide international leadership in protecting the welfare of imported animals. Member countries recognized that from a public-policy perspective, the protection of animals involved many scientific, ethical, economic, and political considerations. Therefore, they endeavored to develop a detailed vision and strategy that would incorporate and balance those consider- ations. Ultimately, the OIE International Committee decided that OIE would give high priority to animals used in agriculture and aquaculture and would address the issues of transportation, humane slaughter, and killing for disease-control purposes first, followed by housing and man- agement. OIE would address other issues, such as research animals and wildlife, as resources permitted. Member countries delegate responsibility for OIE reporting and participation to the directors of their veterinary services. For the United States, the USDA APHIS Associate Deputy Administrator for International Services assumes that role. THE EUROPEAN UNION The European Union (EU) laws regulating the transportation of research animals are enforced by the Health and Consumer Protection Directorate General. Research animal transportation is addressed through legislative and nonlegislative actions in three interrelated policy areas: • Consumer policy (Treaty Articles 95 and 153); • Public health (Treaty Articles 95, 152, and 300); and • Food safety, animal health, animal welfare, and plant health (Treaty Articles 37, 95, and 152). The first EU legislation on the protection of animals during transpor- tation, Council Directive 77/489/EC, resulted from the 1968 Convention of the Council of Europe. It has since been replaced by the more detailed Council Directive 91/628/EC as amended by Directive 95/29/EC, which introduced important changes such as the approval of transporters, the

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30 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS route plan, and loading densities and traveling-time limits. EU legislation on the transportation of live animals applies to all animals transported for commercial purposes. The present framework of general provisions has been introduced by Council Directive 91/628/EEC, which in Chapter I, Part E, provides that: • Animals shall be transported in containers, pens, or stalls appro- priate for the species, complying, at least, with the most recent IATA live- animal regulations. • Precautions shall be taken to avoid extremely high or low tem- peratures on board, having regard for the species of animals. In addition, severe fluctuations of air pressure shall be avoided. • In freight aircraft, a type of instrument approved by the compe- tent authority shall be carried for slaughtering animals if necessary. Council Directive 86/609/EEC was issued on the protection of ani- mals used for experimental and other scientific purposes on November 24, 1986. It sets minimal standards for housing and care and for the training of personnel handling animals and supervising the experiments, but it does not provide specific standards on transportation of animals. Council Regulation 1/2005 was passed in January 2005 and will introduce new rules that will apply directly to each member state effect 2007. These rules introduce changes to improve animal welfare and enforcement, but do not change the maximum journey times that apply through the current Directive.

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31 REGULATIONS AND GUIDELINES FOR TRANSPORTATION TABLE 2-6 Checklist of Research Animal Regulations and Guidelines Yes No Is the species to be transported a Comply with AWA regulations. No action live, warm-blooded animal other Subject to inspection by USDA. required than a bird or an animal of the genus Rattus or Mus? Is the species (or its tissues or Obtain FWS permits, consult: No action products) to be imported or http://www.fws.gov/permits/ required exported considered wildlife applicationmain.shtml (including all CITES-listed species Comply with CDC Foreign and nonhuman primates)? Quarantine Regulations. Comply with IATA LARs. Subject to inspection by FWS. Is the species (or its tissues or Obtain FWS permits, consult: No action products) to be transported http://www.fws.gov/permits/ required (exported, imported, or interstate applicationmain.shtml trade) listed as threatened or Subject to inspection by FWS. endangered by FWS? Comply with IATA LARs. Consult: http://www.fws.gov/ endangered. Is an animal or its products Obtain importation and exportation No action wild-caught, listed under CITES permits from the appropriate required as an Appendix I species, and countries. being transported internationally? Obtain FWS permits, consult: Consult: http://www.fws.gov/permits/ http://www.cites.org/eng/ applicationmain.shtml resources/species.html. Subject to inspection by FWS. Is an animal or its products to be Obtain export permit from country No action transported internationally and of export. required • listed under CITES as an Obtain FWS permits, consult: Appendix II species http://www.fws.gov/permits/ applicationmain.shtml OR • a captive-born animal and Subject to inspection by FWS. listed under CITES as an Appendix I species? Consult: http://www.cites.org/eng/ resources/species.html. Is the species to be imported a Dogs require proof of rabies No action dog or cat? vaccination. required Subject to inspection by CDC. continued

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32 GUIDELINES FOR THE HUMANE TRANSPORTATION OF RESEARCH ANIMALS TABLE 2-6 Continued Yes No Is the species to be imported a Obtain permit, written permission, No action nonhuman primate, African or registration from CDC required rodent, civet, turtle of carapace Division of Global Migration length of less than 4 in., or other and Quarantine. species prohibited by CDC? Subject to inspection by CDC. Consult http://www.cdc.gov/ ncidod/dq/animal.htm. Is the species to be imported a Submit OMB Form 0920-0199 to No action live bat or animal, insect, or CDC’s Etiologic Agent Import required animal tissue that contains an Permit Program. etiologic agent? Does the animal or animal product Contact DOT’s Hazardous No action to be transported contain Materials Information Center required poisonous, radioactive, or for further requirements. infectious material? If shipped by air, comply with IATA DGRs. Are the species to be transported Comply with PHS Policy and Guide No action live, vertebrate animals that were for the Care and Use of Laboratory required purchased with PHS funds? Animals. Is the animal to be transported Submit written request for No action within the United States a permission from Listed Animal required nonhuman primate, African Permit Official at FDA’s Center rodent, civet, turtle of carapace for Veterinary Medicine. length of less than 4 in., or other species prohibited by FDA? Consult http://www.fda.gov/cvm/ Is the animal being imported into Comply with regulations from No action the United States or traveling destination state available at: required between states? http://www.aphis.usda.gov/ vs/sregs Comply with CDC Foreign Quarantine Regulations. Wildlife-specific state regulations are available at: http:// offices.fws.gov/statelinks.html Is the animal being transported Comply with IATA LARs No action by air? (all species) required Comply with 50 CFR 14 subpart J (AWA-covered species only)