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Guidelines for the Humane Transportation of Research Animals 2 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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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 Agency Agency Program or Federal Regulation Nonhuman Primates Cats and Dogs Interstate Import/export Interstate Import/export USDA Animal Welfare Act X X X X FWS CITES X ++ Lacey Act X X Endangered Species Act X X CDC Division on Global Migration and Quarantine (DGMQ) X* X* Etiologic Agent Import Permit Program (EAIPP) DOT Infectious Substances Program Radioactive/Poisonous Materials Program FDA 42 CFR 70.2 and 21 CFR 1240.30 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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Guidelines for the Humane Transportation of Research Animals Rats of genus Rattus, Mice of genus Mus, and Birds (Interstate, Import, Export) All Other Warm-blooded Vertebrates (Interstate, Import, Export) Wildlife (or products of wildlife) (Interstate, Import, Export) Endangered/Threatened Wildlife (or products thereof) (Interstate, Import, Export) Live Animals with Zoonotic/Infectious Diseases (Interstate, Import, Export) Animal Products with Zoonotic/Infectious Diseases (Interstate, Import, Export) Live Animals Containing Radioactive/Poisonous Material (Interstate, Import, Export) Animal Products Containing Radioactive/Poisonous Material (Interstate, Import, Export) X X X X X X X X*,+ +++ X**,+ X** X X X X X***
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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, treatment, and transportation of animals (AWA, 7 USC 2131 et seq.). AWA regulatory authority is vested in the Secretary of Agriculture and implemented 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 regulation 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 standards for consignment (delivery of animals to an entity for transport), primary transportation enclosure, primary conveyance, food and watering 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 1 Wildlife (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 transportation 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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Guidelines for the Humane Transportation of Research Animals 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 elsewhere 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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Guidelines for the Humane Transportation of Research Animals TABLE 2-2 Designated Port for Importation or Exportation of Wildlife or Derivatives Ports Designated for Endangered or Threatened Species Ports Designated for Wildlife Originating in Canada or the United States Ports Designated for Wildlife Originating in 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 Ports Designated for Import/Export of Wildlife from Alaska Louisville, KY Eastport, ID Memphis, TN Grand Portage, MN Miami, FL Highgate Springs, VT 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 administering 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 application is used to obtain both an ESA and CITES permits, though not all species listed under ESA are CITES-listed species and vice versa. Applications generally require 60-90 days for processing.
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Guidelines for the Humane Transportation of Research Animals TABLE 2-3 Endangered Species Act Listed Species of Nonhuman Primates Endangered Allocebus spp. (hairy-eared dwarf lemurs) Alouatta palliate (mantled howler monkey) Ateles geoffroyi frontatus (Central American spider monkey) Ateles geoffroyl panamensis (Central American spider monkey) Avahi spp. (Avahi, woolly lemurs) Brachyteles arachnoids (woolly spider monkey) Bradypus torquatus (Brazilian three-toed sloth) Cacajao spp. (uakaris) Callimico goeldii (Goeldi’s marmoset) Callithrix aurita (buffy tufted-ear, white-eared marmoset) Callithrix flaviceps (buff-headed marmoset) Cercocebus galeritus galeritus (Tana River mangabey) Cercocebus torquatus (white-collared mangabey) Cercopithecus Diana (Diana monkey) Cercopithecus erythrogaster (red-bellied monkey) Cercopithecus erythrotis (red-eared nose-spotted monkey) Cercopithecus lhoesti (L’hoest’s monkey) Cheirogaleus spp. (dwarf lemurs) Chiropotes albinasus (white-nosed saki) Chiropotes satanas satanas (southern bearded saki) Colobus satanas (black colobus monkey) Daubentonia madagascariensis (Aye-aye) Gorilla gorilla (gorilla) Hapalemur spp. (bamboo lemurs and gentle lemurs) Hylobates spp. (including Nomascus) (gibbons) Indri spp. (indri) Lagothrix flavicauda (yellow-tailed woolly monkey) Lemur spp. (ring-tailed lemurs) Leontopithecus spp. (golden-rumped tamarin) Lepilemur spp. (sportive lemurs) Macaca silenus (lion-tailed macaque) Mandrillus leucophaeus (drill) Mandrillus sphinx (mandrill) Microcebus spp. (mouse lemurs) Monkey, black howler Nasalis concolor (Pagi Island langur) Nasalis larvatus (proboscis monkey) Pan paniscus (pygmy chimpanzee—wild) Pan troglodytes (wild chimpanzee) Phaner spp. (fork-marked lemurs) Planigale ingrami subtilissima (little planigale) Pongo pygmaeus (orangutan) Procolobus pennantii kirki (Zanzibar red colobus monkey) Procolobus preussi (Preuss’ red colobus monkey) Procolobus rufomitratus (Tana River red colobus monkey) Propithecus spp. (sifakas) Pygathrix nemaeus (douc langur) Rhinopithecus avunculus (Tonkin snub-nosed monkey) Rhinopithecus bieti (Yunnan snub-nosed monkey) Rhinopithecus brelichi (guizhou snub-nosed monkey) Rhinopithecus roxellana (Sichuan snub-nosed monkey) Saguinus bicolor (pied tamarin) Saguinus oedipus (cotton-top marmoset) Saimiri oerstedii (red-backed squirrel monkey) Semnopithecus entellus (gray, Hanuman langur) Tamarin, white-footed Trachypithecus francoisi (Francois’ langur) Trachypithecus geei (golden langur) Trachypithecus pileata (capped langurs) Varecia spp. (ruffed lemur, variegated lemurs) Threatened Alouatta pigra (black howler monkey) Macaca arctoides (stump-tailed macaque) Macaca cyclopis (Formosan rock macaque) Macaca fuscata (Japanese macaque) Macaca sinica (Toque macaque) Nycticebus pygmaeus (lesser slow lorise) Pan troglodytes (chimpanzees—captive) Presbytis potenziani (long-tailed langur) Presbytis senex (purple-faced langur) Saguinus leucopus (white footed tamarin) Tarsius syrichta (Philippine tarsier) Theropithecus gelada (gelada baboon)
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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 provided 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 component of the US Department of Health and Human Services and enforces regulations to prevent the introduction, transmission, or spread of communicable 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 primates, 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 containing 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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Guidelines for the Humane Transportation of Research Animals imported into the United States for bona fide scientific, educational purposes, 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 prohibited 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 permitted. 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 assessing 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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Guidelines for the Humane Transportation of Research Animals human primates and to register as an importer of nonhuman primates, contact 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 importation 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 specifically 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 Hazardous 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 Hazardous 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 transported in the course of biomedical research. An infectious substance is defined by DOT as a material known to contain or suspected of containing 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 Hazardous Materials Safety. The HMR cover five areas of shipper responsibility: Determining the hazard class(es) of the material offered for transportation; 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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Guidelines for the Humane Transportation of Research Animals The majority of these tasks are performed by the shipper. The carrier must also ensure that the materials received comply with and are transported 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, poisonous, or radioactive animal products or live infectious animals, should contact 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 animals 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 compliance 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 commissioner 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 purposes of commerce, sale, or any other type of commercial or public distri-
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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, respectively). 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 permit to transport nonhuman primates into the state. Links to the regulations 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 animals 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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Guidelines for the Humane Transportation of Research Animals 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 international 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 commercial and noncommercial trade. It includes the importation, exportation, 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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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 extinction 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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Guidelines for the Humane Transportation of Research Animals TABLE 2-4 Permitting Requirements Under CITES Appendix I Appendix II Appendix III Importation and exportation permits required Exportation permit required if exporting from any country Exportation permit required only if exporting from the nation that listed the species in Appendix III Permits are limited to 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 certificate by that management authority stating that the animal was bred in captivity may be accepted in lieu of any other required permits or certificates (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 generation 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 international 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 necessary 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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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) Alouatta palliate (mantled howler monkey) Alouatta pigra (Mexican black howler monkey) 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) All primate species not listed in Appendix I
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Guidelines for the Humane Transportation of Research Animals 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 developed 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 transported. 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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Guidelines for the Humane Transportation of Research Animals Administration, and include toxic, infectious, and radioactive animal tissues, 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 January 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 veterinary 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 worldwide. During the recent outbreak of avian influenza in Asia, OIE played a
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Guidelines for the Humane Transportation of Research Animals crucial role in alerting countries of the outbreak and recommending courses of action. As a result of OIE’s activities, many countries temporarily 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 strategic plan. Although OIE had not been specifically mandated by the WTO SPS to protect animal welfare, the OIE’s status as the international authority 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 considerations. 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 management. 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 transportation, 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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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 appropriate for the species, complying, at least, with the most recent IATA live-animal regulations. Precautions shall be taken to avoid extremely high or low temperatures 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 competent authority shall be carried for slaughtering animals if necessary. Council Directive 86/609/EEC was issued on the protection of animals 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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Guidelines for the Humane Transportation of Research Animals TABLE 2-6 Checklist of Research Animal Regulations and Guidelines Yes No Is the species to be transported a live, warm-blooded animal other than a bird or an animal of the genus Rattus or Mus? Comply with AWA regulations. Subject to inspection by USDA. No action required Is the species (or its tissues or products) to be imported or exported considered wildlife (including all CITES-listed species and nonhuman primates)? Obtain FWS permits, consult: http://www.fws.gov/permits/applicationmain.shtml Comply with CDC Foreign Quarantine Regulations. Comply with IATA LARs. Subject to inspection by FWS. No action required Is the species (or its tissues or products) to be transported (exported, imported, or interstate trade) listed as threatened or endangered by FWS? Consult: http://www.fws.gov/endangered. Obtain FWS permits, consult: http://www.fws.gov/permits/applicationmain.shtml Subject to inspection by FWS. Comply with IATA LARs. No action required Is an animal or its products wild-caught, listed under CITES as an Appendix I species, and being transported internationally? Consult: http://www.cites.org/eng/resources/species.html. Obtain importation and exportation permits from the appropriate countries. Obtain FWS permits, consult: http://www.fws.gov/permits/applicationmain.shtml Subject to inspection by FWS. No action required Is an animal or its products to be transported internationally and listed under CITES as an Appendix II species OR a captive-born animal and listed under CITES as an Appendix I species? Consult: http://www.cites.org/eng/resources/species.html. Obtain export permit from country of export. Obtain FWS permits, consult: http://www.fws.gov/permits/applicationmain.shtml Subject to inspection by FWS. No action required Is the species to be imported a dog or cat? Dogs require proof of rabies vaccination. Subject to inspection by CDC. No action required
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Guidelines for the Humane Transportation of Research Animals Yes No Is the species to be imported a nonhuman primate, African rodent, civet, turtle of carapace length of less than 4 in., or other species prohibited by CDC? Consult http://www.cdc.gov/ncidod/dq/animal.htm. Obtain permit, written permission, or registration from CDC Division of Global Migration and Quarantine. Subject to inspection by CDC. No action required Is the species to be imported a live bat or animal, insect, or animal tissue that contains an etiologic agent? Submit OMB Form 0920-0199 to CDC’s Etiologic Agent Import Permit Program. No action required Does the animal or animal product to be transported contain poisonous, radioactive, or infectious material? Contact DOT’s Hazardous Materials Information Center for further requirements. If shipped by air, comply with IATA DGRs. No action required Are the species to be transported live, vertebrate animals that were purchased with PHS funds? Comply with PHS Policy and Guide for the Care and Use of Laboratory Animals. No action required Is the animal to be transported within the United States a nonhuman primate, African rodent, civet, turtle of carapace length of less than 4 in., or other species prohibited by FDA? Consult http://www.fda.gov/cvm/ Submit written request for permission from Listed Animal Permit Official at FDA’s Center for Veterinary Medicine. No action required Is the animal being imported into the United States or traveling between states? Comply with regulations from destination state available at: 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 No action required Is the animal being transported by air? Comply with IATA LARs (all species) Comply with 50 CFR 14 subpart J (AWA-covered species only) No action required
Representative terms from entire chapter: