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 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 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.

TABLE 2-2

Designated Port for Importation or Exportation of Wildlife or Derivatives.

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:

TABLE 2-3

Endangered Species Act Listed Species of Nonhuman Primates.

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 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.

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.

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.

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- 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- 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 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:

TABLE 2-4

Permitting Requirements Under CITES.

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 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.’

TABLE 2-5

CITES Listed Species of Nonhuman Primates.

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.

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.

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 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 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.

TABLE 2-6

Checklist of Research Animal Regulations and Guidelines.

Footnotes

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 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.