6

International, National, and State Regulatory Requirements

The second day of the workshop began by focusing on the regulatory oversight of transporting laboratory animals, with representatives of several regulatory agencies reviewing the guiding principles involved in transport. Each agency or organization has a unique role in the process and oversees different components of the transport, but the number and scope of regulations can generate uncertainty about successfully meeting the many requirements.

WORLD ORGANISATION FOR ANIMAL HEALTH

OIE, which is based in Paris, came into being almost 100 years ago, when a shipment of diseased cattle left India for Brazil. The cattle passed through Belgium, infecting European farms with rinderpest virus that killed countless animals and caused widespread devastation.

OIE has three basic goals, said P. Gary Egrie, farm animal welfare coordinator with USDA. The first is to convey information among countries to enhance safe trade. “If country X has a disease,” said Egrie, “inform us so we can take actions to prevent those diseases from moving in international trade.” The second is to coordinate responses among countries so that those responses are more effective. The third is to harmonize standards among the 180 member countries of the organization, representing most of the world’s countries. OIE is designated by the World Trade Organization as the scientific reference body for animal health.

OIE’s guidelines originally were developed around issues that Egrie called “low-hanging fruit,” including animal transportation, slaughter, and stray dog control, through four commissions within the organi-

zation.¹ New mandates of OIE include animal welfare, animal food production safety, and veterinary infrastructure. Each commission includes a rotating group of specialists who ultimately decide what standards are adopted. The Biological Standards Commission, for example, would set the standards for how testing for tuberculosis is done. The United States has a representative on both the Terrestrial Animal Health Standards Commission and the Biological Standards Commission.

OIE has developed guidelines on the transport of animals by air, sea, and land. It also sets forth standards for the use of animals in research and education, Egrie noted.

U.S. CUSTOMS AND BORDER PROTECTION

Romelito Lapitan discussed his work with the U.S. Customs and Border Protection (CBP), the agency that oversees U.S. borders and ports of entry. According to Lapitan, currently the director of the Ag/Bio-Terror Countermeasures Division within the Office of Field Operations, Agriculture Programs and Trade Liaison, CBP is first in line, along with the agricultural specialists, to screen and process all foreign agricultural and biological imports into the United States; whether live animals, animal products, and animal by-products or propagative plants, plant products, and plant by-products. CBP assists 49 other federal government agencies enforce compliance to their respective regulatory requirements; such as CDC, USDA’s Animal and Plant Health Inspection Service (APHIS), FWS, the U.S. Department of Transportation, and FDA in preventing entry of exotic pests and diseases that are harmful to American agriculture, wildlife and natural resources, and public health.

CBP inspects and ensures that all foreign agricultural imports and their carriers are legitimate, clean, and free of contaminants and prohibited products that may be harboring animal and plant pests and diseases. CBP’s role on live animal importation, however, is limited to the review of the shipment manifest for accuracy and that all accompanying documents (e.g., import permit, health certificates) required by the regulatory agencies are complete and valid. Non-compliant live animal imports are referred

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¹ Terrestrial Animal Health Standards Commission; Scientific Commission for Animal Diseases; Biological Standards Commission; Aquatic Animals Health Standards Commission. Available at http://www.oie.int/international-standard-setting/specialists-commissions-groups (accessed on September 14, 2017).

to USDA-APHIS Veterinary Services, CDC, and FWS for adjudication. Lapitan said that CBP does not have the facility to hold live animals at the port but will safeguard and take care of the animals until the regulating agency arrives, inspects, and recommends further action to perform. Regulatory actions may lead to re-exportation of the shipment back to its country of origin, transfer of custody from CBP to the regulating agency for further investigations, or released to U.S. commerce once compliance is met.

CBP operates in 328 ports of entry across the country—including 15 pre-clearance stations located in various regions of the world. CBP currently employs approximately 2,415 agricultural specialists who are distributed in 175 ports of entry, where large volume of cargo, foreign mail, and packages enter, and high volume of traffic in international travel is observed. According to Lapitan, not every port is equipped to receive every animal. Hence, APHIS and FWS restrict importation of livestock and wildlife, respectively, to ports designated as quarantine stations unless accompanied by a written port exemption permit to enter in non-designated ports. CDC requires importation of NHPs into the United States only through ports with CDC quarantine stations. Researchers need to keep this in mind when planning the route for their animals, he said. Also, beddings and food materials provided to live animals during transit are not permitted into the United States and, thus, are seized and destroyed.

U.S. FISH & WILDLIFE SERVICE

“If you take one thing away from this program today,” said Sharon Lynn, Senior Wildlife Inspector at FWS, “it is to call the inspector at the port you intend to use to talk about your shipment.” Lynn addressed attendees in her role as one of three senior inspectors stationed at FWS headquarters in nearby Virginia. According to Lynn, agencies have oversight over different issues. CDC, for example, deals with diseases affecting public health. USDA focuses on foreign plant pests, animal diseases, or bioterrorism agents. FWS focuses primarily on conservation issues. Lynn reviewed various IATA regulations, discussed the documentation relating to CITES and various other permits, and referenced the electronic Code of Federal Regulations (e-CFR²).

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² See http://www.ecfr.gov/cgi-bin/ECFR?page=browse (accessed on September 14, 2017).

The FWS website lists all the designated ports with FWS inspectors, which account for just 18 out of the 328 official ports of entry across the United States. Furthermore, if the animals are also regulated by another agency, such as CDC, the port of choice must be staffed by that agency as well. In other words, the choice of ports of entry for bringing animals into the United States is severely limited. For example, Portland is a designated port for FWS but not for CDC; thus, NHPs cannot enter through Portland because it does not have CDC quarantine facilities. “Our inspectors do not have the authority to process or clear a shipment based on just an application,” she said. “You must have a valid import/export license before your shipment shows up. And when you are dealing with live animals, time is of the essence.” Customs clearance is received after FWS has approved the shipment, she said, again urging individuals to call the inspector at the designated port of entry. The inspector “can walk you through the required steps. It often depends on the country of origin. Some countries do not allow export of their wildlife.”

U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION

Gale Galland, who works part time with CDC’s Division of Global Migration and Quarantine, talked to workshop attendees about CDC’s role and authority in regulating the importation of live animals. The team’s primary mission is to prevent and control the transmission of communicable diseases of public health importance. “When you bring in 1,300 animals and you have one sick, it affects the entire cohort, which means extended quarantine for up to 10 weeks,” she said. “You can end up with some catastrophic losses.”

Galland used the import of dogs, which she said must be healthy when they arrive at the port of entry, as an example. If any dog is ill, “we can require that it be seen by a veterinarian at the importer’s expense,” she said. This regulation was put in place to address concerns with rabies. Puppies must be at least 3 months old, but rabies vaccines must be given at least 30 days in advance, which means a 3-month-old puppy still needs to wait 30 days to be imported because rabies vaccines are not fully effective for about 1 month. Exceptions to this requirement are only granted for extenuating circumstances. Animals destined to be used in research, where

rabies vaccination might interfere with the scientific outcomes, may be granted an exception.

Galland talked at length about various regulations regarding NHPs. The animals must undergo three negative tuberculin skin tests before they can be released. If they are sick or die, they have to be tested for filoviruses. In 1989, a group of animals coming into the country through Reagan International Airport in Washington, DC, were infected with what was subsequently termed Ebola Reston filovirus. While six people tested positive for the virus, no one got sick. “Everybody felt like we had really dodged a bullet here, so we began looking at our importers very systematically and inspecting animals at the airports.”

As a result of the Ebola Reston outbreak, regulations involving shipments of NHPs were strengthened, including protective equipment standards for humans who are in close proximity to NHP crates. However, the situation is still not ideal, Galland said, showing recent photos with crates carrying NHPs nestled alongside other packages.

Galland highlighted other challenges, such as the limited number of airlines that will transport NHPs into the United States. Currently, no domestic airline will carry these animals; therefore, they must be transported by land to their final destination, which sometimes means crossing the country. Charter flights often incur scheduling delays and flight interruptions that place more stress on animals and increase the potential for animal illness and death during a long quarantine.

U.S. DEPARTMENT OF AGRICULTURE

Carol Clarke, research specialist with USDA’s APHIS, spoke to the group about the role of APHIS-Veterinary Services. Veterinary Services deals specifically with animal health, through the enforcement of the Animal Health Protection Act. As a result, it only becomes involved with laboratory animals when agriculture may be impacted, such as the presence of a foreign disease like foot-and-mouth disease, or a finding of a select agent infection such as a highly pathogenic strain of avian influenza virus. In addition, fruits and vegetables in the animal enclosures are always a source of concern, as is bedding, especially wood chips from certain countries known to carry pests. APHIS-Plant Protection and Quarantine protects the nation’s agriculture by ensuring the foodstuffs and bedding entering the United States do not contain harmful agents, said Clarke.

Carriers and intermediate handlers have specific requirements for transporting animals, Clarke said (see Box 6-1), including registering with USDA. Interestingly, there is no requirement for the consignor to provide a statement that either a dog or an NHP enclosure meets these requirements. Instead, the airline bears the responsibility for judging the adequacy of the enclosures for these two species.

Clarke referenced an amendment of the Animal Welfare Act affecting the import of dogs that went into effect in 2014.³ With limited exceptions, this new rule prohibits the importation of dogs into the United States for resale, research, or veterinary treatment unless the dogs are in good health, have received all the necessary vaccinations, and are at least 6 months old.

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³ U.S. Department of Agriculture. Animal Welfare Act and Animal Welfare Regulations, 2013. Available at http://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Blue%20Book%20-%202013%20-%20FINAL.pdf (accessed on September 14, 2017).

CONSIDERATIONS AT THE STATE LEVEL

The federal government regulates the entry of animals into the United States from other countries, as well as the interstate movement of animals, but states typically regulate the entry of animals into their own state, explained Daniel Kovich, program manager with the Office of Animal Care and Emergency Response, Division of Animal and Food Industry Services, Virginia Department of Agriculture and Consumer Services. Most states generally provide regulatory exemptions if animals are simply driven through the state, but in Virginia animals should be accompanied by a Certificate of Veterinary Inspection issued by a licensed and accredited veterinarian. Most states, however, do have a prohibited species list that includes dangerous, venomous, or invasive species. Large cats, for example, are on Virginia’s prohibited species list. In such cases, importation may be allowed, but only for bona fide scientific purposes, and advance registration or permits are required.

Kovich reviewed the various terms, in addition to “agricultural animals,” that Virginia uses in categorizing animals:

• “Game species” refer to native or naturalized wildlife.
• Research animals are considered as such only if they are un-

• der the custodianship of a research facility and managed under a protocol approved by the facility’s Institutional Animal Care and Use Committee (IACUC).

• “Companion animals” is a broad definition that includes—in addition to pets—lions, tigers, and circus animals such as elephants.

Most state laws and regulations respect and protect the use of animals in scientific research, but, as is the case at the federal level these protections are under ever increasing scrutiny. Animals expressly bred or sold for research purposes by USDA licensed breeders or dealers are considered companion or agricultural animals until the point of delivery to a research facility.

Kovich noted that Virginia’s laws covering companion animal care are often viewed as a national model. These rules include provision of adequate food, water, and exercise; shelter that is properly cleaned; adequate space in the primary enclosure; and provision of care, treatment, transportation, and veterinary attention when needed. Many of the Virginia regulations mirror already existing federal regulations under the Animal Welfare Act.

While Virginia has many regulations governing animals imported into the state, Kovich explained that a particular requirement may be waived if directly tied to the aim of the research. That waiver, however, is given only to the research facility, so that facility must request the exemption prior to the animal being transported.