E
Microbial Threats of Public Health Significance Originating in Animals or Animal Products at U.S. Ports of Entry

A Commissioned Paper

Prepared by

Nga L. Tran, Dr.P.H., M.P.H., C.I.H.

Jesse Berman, B.S.

Exponent, Inc.

April 7, 2005

INTRODUCTION

At the request of the Institute of Medicine, Exponent prepared this report describing the legal framework that established the inspection activities at U.S. ports of entry (POEs) and the roles and responsibilities of the various agencies involved in the inspection and prevention of public health threats posed by the importation of animals. In addition, day-to-day activities at port locations, communication procedures and protocols between personnel at Centers of Disease Control and Prevention (CDC) quarantine stations and other U.S. port agencies, and readily available budget and capacity information are summarized. Issues and concerns that are potential barriers to successful protection of U.S. borders from diseases in animals are also highlighted. Finally, special considerations for animal issues in the expansion plan of CDC quarantine stations are discussed.

The main sources of information that were used to develop this paper were literature posted at agency websites—those of the U.S. Department of Agriculture (USDA), CDC, and the Department of Homeland Security (DHS) U.S. Customs and Border Protection (CBP)—results of an informal survey of CDC personnel at quarantine stations, and telephone calls to the USDA Animal and Plant Health Inspection Services (APHIS) and state agriculture specialists. Names and affiliations of individuals interviewed for this report are listed in Appendix 1. Questions used in the informal survey are provided in Appendix 2.



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Quarantine Stations at Ports of Entry: Protecting the Public’s Health E Microbial Threats of Public Health Significance Originating in Animals or Animal Products at U.S. Ports of Entry A Commissioned Paper Prepared by Nga L. Tran, Dr.P.H., M.P.H., C.I.H. Jesse Berman, B.S. Exponent, Inc. April 7, 2005 INTRODUCTION At the request of the Institute of Medicine, Exponent prepared this report describing the legal framework that established the inspection activities at U.S. ports of entry (POEs) and the roles and responsibilities of the various agencies involved in the inspection and prevention of public health threats posed by the importation of animals. In addition, day-to-day activities at port locations, communication procedures and protocols between personnel at Centers of Disease Control and Prevention (CDC) quarantine stations and other U.S. port agencies, and readily available budget and capacity information are summarized. Issues and concerns that are potential barriers to successful protection of U.S. borders from diseases in animals are also highlighted. Finally, special considerations for animal issues in the expansion plan of CDC quarantine stations are discussed. The main sources of information that were used to develop this paper were literature posted at agency websites—those of the U.S. Department of Agriculture (USDA), CDC, and the Department of Homeland Security (DHS) U.S. Customs and Border Protection (CBP)—results of an informal survey of CDC personnel at quarantine stations, and telephone calls to the USDA Animal and Plant Health Inspection Services (APHIS) and state agriculture specialists. Names and affiliations of individuals interviewed for this report are listed in Appendix 1. Questions used in the informal survey are provided in Appendix 2.

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health LEGAL FRAMEWORK FOR INSPECTIONS AT U.S. PORTS OF ENTRY The Homeland Security Act of 2002 (HSA, P.L. 107-296) establishes DHS and its directorates. More than 22 federal agencies were consolidated into the new department, including the Immigration and Naturalization Service (INS), the Customs Service, and components of APHIS that conduct inspection and animal quarantine activities at U.S. ports (APHIS, 2003). The HSA specified which laws DHS agricultural inspectors might use to conduct inspections but it did not alter these underlying statutes (CRS, 2004). In addition, the transfer of the inspection functions of INS and Customs Service to DHS did not affect the laws that authorize these inspections. The following sections describe the underlying statutes for various types of inspections at U.S. ports. Agriculture Inspections Agriculture inspectors play an integral part in USDA’s role in supplying a safe and affordable food supply. In part, APHIS was responsible for enforcing the laws that protect and promote U.S. agricultural health from agricultural pests and diseases by conducting inspections at various ports of entry. Under the HSA, APHIS import and entry inspection activities relating to the laws specified below were transferred to DHS. The under secretary for border and transportation security is now responsible for conducting agricultural inspections at ports of entry in accordance with the regulations, policies, and procedures issued by the secretary of agriculture for the following Acts (CRS, 2004): The Virus-Serum-Toxin Act (21 U.S.C. §§151 et seq.). The Honeybee Act (7 U.S.C. §§281 et seq.). Title III of the Federal Seed Act (7 U.S.C. §§1581 et seq.). The Plant Protection Act (7 U.S.C. §§7701 et seq.). The Animal Health Protection Act (7 U.S.C. §§8301 et seq.). The Lacey Act Amendments of 1981 (16 U.S.C. §§3371 et seq.). Section 11 of the Endangered Species Act of 1973 (16 U.S.C. §§1540). In some cases, agriculture inspectors have the authority to conduct warrantless searches of any person or conveyance entering the country in furtherance of those laws. For instance, under the Plant Protection Act and the Animal Health Protection Act, agriculture inspectors have the authority to conduct warrantless searches of any person or vehicle entering the United States to determine whether the person is carrying any plant or animal in

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health violation of the statute (7 U.S.C. §7331 (b)(1) and 7 U.S.C. §8307 (b)(1)). Agriculture inspectors also have the authority under the Lacey Act to detain for inspection any vessel, vehicle, aircraft, package, crate, or other container on the arrival of such conveyance or container in the United States from any point outside the United States (16 U.S.C. §3375). The Endangered Species Act also allows agriculture inspectors to detain for inspection any package, crate, or other container and all accompanying documents on importation (16 U.S.C. §1540). Immigration Inspections The former INS was responsible for enforcing and administering the Immigration and Nationality Act of 1952 (INA) (codified as amended at 8 U.S.C. §§1101 et seq.). The HSA transferred administrative authority over immigration enforcement to the Directorate of Border and Transportation Security. According to DHS regulations, all authorities and functions of the DHS to administer and enforce the immigration laws are now vested in the secretary of DHS or his delegate (8 CFR §2.1).1 Immigration officials possess a wide variety of enforcement mechanisms to carry out their mission of enforcing the INA. Immigration enforcement activities generally include providing border security and management, conducting inspections of persons at U.S. international ports, enforcing immigration law, detaining and removing aliens found in violation of immigration and related laws, and providing immigration intelligence. Customs Inspections Formerly housed in the Department of the Treasury, customs inspectors enforced a number of laws to ensure all imports and exports comply with U.S. laws and regulations, collect and protect U.S. revenues, and guard against the smuggling of contraband. The HSA transferred generally all customs functions (except for certain revenue functions) to DHS in §403. Customs border activities are now conducted through the CBP and interior enforcement activities are carried out by Immigration and Customs Enforcement officers. 1   8 CFR §2.1 states, “the Secretary, in his discretion, may delegate any such authority or function to any official, officer, or employee of the DHS or any employee of the United States to the extent authorized by law.” This regulation was authorized, in part, by §103 of the INA, which was amended by the HSA to charge the secretary of DHS with the administration and enforcement of the INA. There is still some question, however, as to the extent to which the attorney general has concurrent authority.

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health Public Health Inspection The secretary of the Department of Health and Human Services (DHHS) has statutory responsibility for preventing the introduction, transmission, and spread of communicable diseases in the United States. Under its delegated authority, the Division of Global Migration and Quarantine (DGMQ) fulfills this responsibility through a variety of activities, including: Operation of quarantine stations at ports of entry. Establishment of standards for medical examination of persons destined for the United States. Administration of interstate and foreign quarantine regulations that govern the international and interstate movement of persons, animals, and cargo. The legal foundation for these activities is found in Titles 8 and 42 of the U.S. Code and relevant supporting regulations. Interstate and foreign quarantine regulations (42 CFR70 and 71) authorize the secretary of the DHHS, through CDC, to develop and enforce regulations to prevent transmission of infectious disease from foreign countries into the United States. Under these authorities, CDC can set policy to embargo certain animals from entering the United States (DGMQ, 2004). Title III of the Bioterrorism Act provides the secretary of DHHS with new authorities to protect the nation’s food supply. The Public Health Security and Bioterrorism Preparedness Response Act requires notification and controls on the movement of agents or toxins deemed to be a threat to animal or plant health and to animal and plant products. To prevent the incursions of adverse animal health events, APHIS units are working with DHHS to implement the provisions of this act (APHIS, 2004b). Table E.1 provides a summary of agencies that are involved in the inspection of animals and animal products at U.S. ports aimed to protect animal or public health and their legal authorities. AGENCIES AT U.S. PORTS OF ENTRY—ROLES AND RESPONSIBILITIES Deterrence and prevention are the first lines of defense against the introduction of animal and plant pests and pathogens from foreign sources (Personal communication, J. Annelli, APHIS, April 7, 2004). Several strategies are involved in border strategy that focuses on interdicting a threat agent at U.S. POEs (NRC, 2003). For the past several years, there have been 317 official POEs into the United States. At a given port, inspectors may be responsible for more than one mode of transportation (air, land, and sea).

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health TABLE E.1 Legal Authorities for Inspections at U.S. Borders Agency Legal and Regulatory Foundation Authorities DHHS-CDC Titles 8 and 42 of the U.S Code and relevant supporting regulations, such as Interstate Quarantine (42 CFR 70) and Foreign Quarantine (42 CFR 71). Authorizes CDC National Center for Infectious Diseases, DGMQ to make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States.   The Foreign Quarantine regulation (42 CFR Part 71.54, Etiologic Agents, Hosts, and Vectors) Governs the importation of hazardous materials (etiologic agents, vectors, and materials containing etiologic agents). Importation into the United States must be accompanied by a U.S. Public Health Service importation permit. CDC regulations govern the importation of dogs, cats, turtles, monkeys, other animals, and animal products capable of causing human disease. Under these regulatory authorities, CDC has established an embargo on monkeys and other animals that could carry monkey pox virus, and birds from specified Southeast Asian countries. DHHS-FDA Title III of the Bioterrorism Act Provides the DHHS secretary with new authorities to protect the nation’s food supply against the threat of intentional contamination and other food-related emergencies. The Food and Drug Administration expects up to 420,000 facilities to register under this requirement.

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health Agency Legal and Regulatory Foundation Authorities DHS The Homeland Security Act of 2002 Establishes DHS and its directorates. U.S. Customs and Border Protection Subtitle A, Title IV, of the Homeland Security Act of 2002 (6 U.S.C 201 et seq.) Establishes Border and Transportation Security (CBP resides in this directorate). CBP is responsible for controlling all U.S. land, sea, and air borders; protects U.S. economic security by regulating and facilitating the lawful movement of goods and persons across U.S. borders. Agricultural Quarantine Program (border inspection) (former APHIS). APHIS The Animal Industry Act of 1884 as amended (21 U.S.C. 117) The Cattle Contagious Diseases The Act of 1903 as amended (21 U.S.C. 111-115, 117, 120, 123, 125-127, 134), The Farm Security and Rural Investment Act of 2002, Subtitle E Animal Health Protection Act (PL 107-171), 21 U.S.C. 114 The Animal Industry Act of 1988 The Virus-Serum-Toxin Act (21 U.S.C. §§151 et seq.) The Honeybee Act (7 U.S.C. §§281 et seq.) Title III of the Federal Seed Act (7 U.S.C. §§1581 et seq.) The Plant Protection Act (7 U.S.C. §§ 7701 et seq.) Provides secretary of USDA broad authority and discretion to prevent, detect, control, and eradicate diseases of pests and animals and to promulgate regulations and take measures to prevent introduction and interstate dissemination of communicable diseases of livestock within the U.S. Legal bases for APHIS monitoring and surveillance programs.

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health   The Lacey Act Amendments of 1981 (16 U.S.C. §§3371 et seq.) Section 11 of the Endangered Species Act of 1973 (16 U.S.C. §§1540)     9 CFR, Part 53, amended in 1985 (21 U.S.C., Section 151 et seq.) To respond to certain foreign animal diseases (FADs) and other communicable diseases of livestock or poultry and pay claims growing out of destruction of animals.   9 CFR subchapter B To establish cooperative programs to control and eradicate communicable diseases of livestock.   The Foreign Service Act (1980) and Executive Order 12363 (1982) APHIS International Services (IS) activities. U.S. Fish and Wildlife Services Migratory Bird Treaty Act (16 U.S.C. 668-668C) Lacey Act (18 U.S.C. 703-712) Endangered Species Act (16 U.S.C. 1531-1543) Prohibits possession, purchase, or barter of migratory bird, feathers or other parts. Prohibits importation, exportation, transportation, sale, or purchase of fish and wildlife in violation of state, federal, tribal, and foreign laws. Prohibits the importation, exportation, taking, and commercialization in interstate or foreign commerce of fish, wildlife, and plants that are listed as threatened or endangered species. Implements provisions of the Convention on International Trade in Endangered Species (CITES).   SOURCES: Bush, 2002; Crawford, 2003; Creekmore, 2003; DGMQ, 2003b, 2004; Grannis, 2003; OMB, 2004b; OSH, 2004; USFWS, 2003.

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health Buffalo and Detroit, for example, have air, sea, and land POEs. The likelihood of inspectors having multiple responsibilities is greater at the smaller POEs. CBP currently reports there are 216 airports that are international POEs, 143 seaports, and 115 land POEs. Two locations are inland POEs (CRS, 2004). The roles and responsibilities of the various agencies involved in the inspection and prevention of animals and animal products that could pose a public health threat by entering the United States are described below. Department of Health and Human Services (DHHS), Centers for Diseases Control and Prevention (CDC) The foreign quarantine regulation (42 CFR Part 71.54, Etiologic Agents, Hosts, and Vectors) governs the importation of hazardous materials (etiologic agents, vectors, and materials containing etiologic agents (OSH, 2004). CDC has established regulations that govern the importation of dogs, cats, turtles, monkeys, other animals, and animal products capable of causing human disease. Under these regulatory authorities, CDC has established an embargo on monkeys and other animals that could carry the monkeypox virus and on birds from specified Southeast Asian countries (DGMQ, 2004). CDC officials are not present at the border on a day-to-day basis, but there are quarantine stations at the international airports in Atlanta, New York, Miami, Chicago, Los Angeles, San Francisco, Seattle, and Honolulu. The quarantine operations involve coordination of numerous agencies, including (DGMQ, 2003a): Epidemic Intelligence Service (EIS) and other parts of CDC. State and local health departments. CBP. USDA. U.S. Fish and Wildlife Service. The aircraft and maritime industry. The CDC National Center for Infectious Diseases (NCID) DGMQ trains CBP inspectors to watch for ill persons and items of public health concern, and they work with state and local health officials in jurisdictions that may be affected under particular circumstances (CRS, 2004). DHS Border and Transportation Security (BTS), U.S. Customs and Border Protection (CBP) On November 21, 2002, President Bush signed legislation creating DHS to unify federal forces and protect the nation from a new host of

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health terrorist threats. Approximately 2,600 employees from the APHIS Agriculture Quarantine and Inspection (AQI) force became part of CBP on March 1, 2003 (APHIS, 2003). This network of veterinary inspectors and animal health inspectors at all U.S. POEs is the first line of defense in identifying materials entering the United States that may be introducing foreign animal diseases. DHS acquired USDA’s authority to inspect passenger declarations and cargo manifests, international passengers, baggage, cargo, and conveyances and to hold suspect items for quarantine to prevent the introduction of plant or animal diseases (GAO, 2005). A summary of the programmatic elements and functions of CBP is provided in Table E.2. APHIS Veterinary Services Although DHS is now responsible for protecting the nation’s border and the border inspection function of APHIS has moved to DHS, APHIS retains a significant presence in border inspection activities. The nearly 1,300 AQI employees who were not transferred continue to conduct certain domestic inspection functions, such as monitoring entry to the mainland from Hawaii and Puerto Rico (CRS, 2004). Through risk assessment, pathway analysis, and rule making, APHIS continues to set agricultural policy, including specific quarantine, testing, and other conditions under which animals, animal products, and veterinary biologics can be imported. APHIS policy is then carried out by DHS (APHIS, 2003). At POEs, there are also APHIS Veterinary Services (VS) port veterinarians who inspect live animals at border ports and animals in quarantine until testing is completed. They are at 43 VS office areas and report to the veterinarian in charge of the VS area office (Personal communication, J. Annelli, APHIS, April 7, 2004). With agricultural border inspectors now being a part of DHS, VS has identified the need for developing new protocol for training and interacting with these inspectors and the need to work with DHS to implement improvements recommended in the Animal Health Safeguarding Review regarding exclusion activities in its strategic plan (APHIS, 2004b). To ensure that necessary agricultural inspections are conducted, APHIS negotiates memoranda of understanding (MOUs) with DHS. The VS National Center for Import/Export works to facilitate international trade; monitors health of animals presented at borders; regulates import and export of animals, animal products, and biologics; and diagnoses foreign and domestic animal diseases. This center works in partnership with the Department of the Interior’s (DOI) Fish and Wildlife Service (USFWS), the APHIS Plant and Protection Quarantine, and CBP (APHIS, 2004a).

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health TABLE E.2 DHS, Border and Transportation Security, U.S. Customs and Border Protection, and Components Addressing Animal Diseases Agencies Function Border and Transportation Security (BTS) The largest of the five DHS directorates. Includes former U.S. Customs Service, border security function and enforcement division of INS, APHIS, Federal Law Enforcement Training Center, and the Transportation Security Administration. Responsible for securing the nation’s air, land, and sea borders. Responsible for securing the nation’s transportation systems and enforcing the nation’s immigration laws. U.S. Customs and Border Protection (CBP) March 1, 2003, approx. 42,000 employees were transferred from U.S. Customs Service, INS, and APHIS to the new CBP, a new agency under the BTS Directorate within DHS. Approximately 2,700 former USDA employees from the AQI program and APHIS were transferred into DHS. Former APHIS Plant Protection and Quarantine personnel at POEs who were directly involved in terminal and plane inspections (100% time) were transferred to DHS; those with 60-70% time not doing inspection at terminals or planes were not transferred. The agricultural import and entry inspection functions that were transferred include reviewing passenger declarations and cargo manifests to target high-risk agricultural passengers or cargo shipments. The new CBP also carries out the traditional missions of the predecessor agencies making up CBP (seizing illegal drugs and other contraband at the U.S. border; apprehending people who attempt to enter the United States illegally; detecting counterfeit entry documents; determining the admissibility of people and goods; protecting our agricultural interests from harmful pests or diseases; regulating and facilitating international trade; collecting duties and fees; and enforcing all laws of the United States at our borders). Office Field Operations (OFO) Oversees over 25,000 employees at 20 office field operations (OFOs), 317 POEs, and 14 preclearance stations in Canada and the Caribbean. Responsible for enforcing customs, immigration, and agriculture laws and regulations at U.S. borders.

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health   Manages core custom and border protection programs (i.e., border security and facilitation, interdiction and security, passenger operations, targeting analysis and canine enforcement, trade compliance and facilitation, trade risk management, enforcement, and seizures and penalties and examines trade operations to focus on antiterrorism. Administers Agricultural Inspection Policy and Programs, AQI at all POEs to protect the health of U.S. plant and animal resources. Administers immigrations policy programs. Annual operating budget of $1.1 billion. Each OFO is run by a director of field operations (DFO). Associate Commissioner of Agricultural Inspection Policy and Programs Policy adviser to the Office of the Commissioner on all agricultural issues. CBP port director On March 1, 2003, CBP designated one port director at each POE in charge of all federal inspection services, establishing a single, unified chain of command. CBP agricultural specialist Enforces USDA regulations and seizes any articles in violation of those regulations. Conducts prearrival risk analysis. Examines cargo for quarantine disease and pests. Collects and prepares pest and disease samples and submits to USDA. Handles seizures, safeguarding, destruction, or reexportation of inadmissible cargo. Negotiates compliance agreements with importers of regulated commodities. Stationed only at POEs with large volumes of cargo and only to support the CBP officers. As of 10/4/2003, there were 1,471 full-time permanent agricultural inspectors on-board. New CBP officers will be trained at the Federal Law Enforcement Training Center (FLETC) in Glynco, GA, and agricultural specialists will continue to learn their trade at PPQ Professional Development Center in Frederick, MD. Farm groups and some members of Congress have questioned whether CBP officers will receive enough agricultural training.

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health the established working relationship between CDC personnel and agricultural inspectors (who are experienced former APHIS staff). With the reorganization of homeland security and the changing staff within DHS, it is becoming more difficult for CDC personnel to keep track of who in CBP is working on what project and who is in charge. CDC is finding it difficult to contact the right person to make sure that proper inspection procedure is being conducted to ensure public health protection. In addition, there is some concern regarding the reassignment of CBP inspectors into new jurisdictions that are no longer in alignment with their training or expertise. While written protocol was not found for CDC personnel, there exists a procedure manual for animal product inspection that was created by APHIS Plant Protection and Quarantine (PPQ): the Animal Product Manual (APM), second edition, September 2004 (PPQ, 2004). The manual describes in detail the procedures to be used by CBP agricultural inspectors and APHIS PPQ Officers to assist them in deciding regulatory issues and referral protocols. The APM spans airport, maritime, and border operations. While primarily for regulatory decisions associated with imported cargo, the manual has an appendix that deals with baggage and the mail. The APM also has sections on procedures that cover such things as disinfection, export certification of animal products, handling of pet birds, collecting of user fees, and a glossary that provides some background on the variety of animal products the CBP agricultural inspectors and PPQ officers may encounter. The manual summarizes the referral systems described below. U.S. Fish and Wildlife Service (USFWS) Referral to a USFWS officer or to CBP if a USFWS officer is unavailable: All nonfarm animals, including birds, but excepting horses, cattle, sheep, goats, swine, dogs, cats, and pet birds. Animal byproducts such as pelts, coats, skins, game trophies, ivory products, and tortoiseshell products; and egg importations if from an endangered or threatened bird. Abandoned pet birds (also contact VS, which has jurisdiction over birds). All amphibians, fish, and reptiles (to determine whether they are protected by CITES). Food and Drug Administration (FDA) Referral of the following importations to CBP for referral to an FDA inspector:

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health Any drug, medication, or food intended for animals that FDA has indicated an interest in. A local FDA inspector should be consulted for specific items of interest. Commercial importations of food products. Wild fowl meat. Wild ruminant meat. Food Safety and Inspection Service (FSIS) All meat, meat products, and shell eggs for breaking (i.e., unprocessed shelled eggs for consumption) must be referred to both Customs and FSIS. Exporters should be directed to request FSIS export certification of meat and meat products. Foreign countries must have FSIS approval that the foreign inspection service is the equivalent of FSIS. The foreign country is then allowed to issue certificates for the commercial importation of meat and meat products. In addition, FSIS inspects and samples imported meat and meat products for meeting APHIS requirements and regulations designed to prevent the spread of animal diseases. Referral of importations of shell eggs for breaking to FSIS to issue FSIS Form 5200-8, Import Request Egg Products. DHHS Public Health Service Referral of the following importations to customs for referral to the local Public Health Service inspector: Dogs, cats, and monkeys (nonhuman primates). Lather brushes made from hair and bristles. Human tissues, serum, blood, secretions, and excretions. If it is questionable whether an importation is of animal origin and has been imported for biological use, the question should go to a supervisor or PPQ Veterinary Regulatory Support (VRS). APHIS Veterinary Services (VS) VS regulations control domestic and foreign commerce in live animals, live poultry, and their products. Since 1971, VS and PPQ have shared the responsibility for implementing, enforcing, and administering animal product and foreign garbage regulations and policies to prevent the introduction of foreign animal diseases. The following should be referred to the local VS office:

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health All live animals, live birds, and hatching eggs. Animal semen, ova, or embryo importations; empty containers are handled by PPQ. Dogs imported to handle livestock except dogs from Canada, Mexico, Central America, and the West Indies. Abandoned pet birds (USFWS should also be contacted). ISSUES AND CONCERNS Interviewed CDC personnel and others raised a number of issues and concerns about potential barriers to successful protection of U.S. borders from diseases in animals. These issues and concerns are summarized below. Special considerations for expansion of CDC quarantine stations are also described. Information Access The biggest challenge to efforts to prevent public health threats from animal diseases imported into the United States is keeping knowledge current and getting information in a timely fashion. Interviewed New York state agriculture officials indicated that while federal agencies are fairly successful in mitigating the threat of human diseases transferred by animals in most cases, they have not been so successful in some situations, such as that of monkeypox. This is a result of failure to pass information on to local inspectors as to what the “hot” diseases are. In a recent Government Accountability Office (GAO) report (March, 2005), it is noted that CBP’s agricultural inspectors do not always receive timely information about high-risk cargo that should be held for inspection (GAO, 2005). For example, after Canada confirmed a case of bovine spongiform encephalopathy in 2003, inspectors at one border crossing did not receive a warning from USDA to hold shipments of Canadian beef in time to intercept it, and they let the shipment through. In another instance, CBP’s inspectors at a seaport in a major agricultural state did not receive an alert in late 2004 about an outbreak of a strain of avian influenza that can cause death in humans until a week after the warning was released. Agricultural inspectors and port officials attributed the delay in receiving information to the transfer of some inspection roles and responsibilities from USDA to DHS. This transfer has created additional layers of communication that have impeded the rapid delivery of critical information to port inspectors. USDA used to communicate critical information directly to its agricultural inspectors, but CBP’s inspectors now receive information indirectly through DHS headquarters. CDC is usually notified of imports from the airline carriers or CBP or

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health APHIS inspectors who are out in the field. As the lead agency at U.S. ports, CBP has access to the Automated Manifest System (AMS), which gives advance notification of any shipments that are coming into the country and allows electronic clearance of shipments. CDC does not have access to the AMS and therefore has to rely on CBP for information. Because of the lack of access to the AMS, both CDC and USFWS require hard copies from the airlines and shippers about their importation. However, under the new Trade Act, airlines and brokers are no longer required to have hard copy of importations. CDC is concerned that compliance with requests for hard copies will cease in the future. It is also concerned about complete reliance on CBP for information since CBP is regulation-driven and does not necessarily focus on animals when it reviews the AMS. Access to the AMS would enable CDC to review incoming cargo and to capture importations of public health interest. Human Resources Lack of adequate staff at CDC quarantine stations is the primary concern among the interviewed CDC personnel. With severely limited human resources, CDC has had to rely on other agencies to enforce most of its regulations at U.S. POEs and is not able to oversee the vast majority of the importations. Consequently, CDC has had to accept on faith that most items are being imported with the appropriate permits or are innocuous. CDC’s ability to grasp the full picture of what goes on at U.S. POEs that may have public health implications is severely affected by lack of staff. The ratio of CDC to CBP agricultural inspection staff (former APHIS staff) is about 1:50. Given this disparity, there are not enough CDC personnel and time to conduct all the necessary training, communication, and education to keep knowledge current among CBP’s inspection staff. Another problem is that the CDC is open only during regular business hours, while CBP and APHIS are open 24 hours a day. Since shipments can come in at any hour, this makes it very difficult and haphazard for animals to have to wait until morning to be looked at. It is also costly to have to keep animals fed and watered. The lack of veterinarian expertise at CDC quarantine locations is also of concern. Although basic knowledge of how to identify animal diseases and work with animals exists among some CDC staff at most quarantine locations, the level of training and depth of knowledge are too limited and not uniform. At the New York port location, while there is a good working relationship with veterinarians at APHIS and the state Department of Agriculture (DOA), consideration for having veterinary support in the field from CDC is suggested. One of the major issues with APHIS and DOA veterinarians is that they are not assigned to the CDC and are not always

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health available on short notice. A CDC veterinarian will not have these prior engagements and can focus on zoonotic disease. Another advantage of having a CDC veterinarian is that he or she will have a direct link with CDC headquarters (unlike APHIS veterinarians), can help keep the local inspectors apprised of new and emerging disease threats to humans, and can speed the process of moving living organisms through quarantine. CDC veterinarians would also be an important asset in the occurrence of an outbreak, since they are better educated to handle a zoonotic threat and can better identify symptoms of new illness. It is envisioned by certain ports that a CDC veterinarian would spend part of the his or her time assisting in the physical inspection of live animals while educating inspectors and other port or airline employees about identifying and preventing zoonotic threats perceived by CDC. Specific concerns are also being raised that primary inspectors in CBP from customs and immigrations backgrounds may not have sufficient agricultural training. Some have argued that current CBP training in agriculture for new inspectors may be inadequate. Former APHIS inspectors had required science and biology backgrounds combined with extensive pest and disease training (CRS, 2004). Regulatory and Policy Issues Noted as an area with overlapping regulatory authority between federal agencies are birds from Asia, which are regulated by both CBP and CDC. Some species of nonhuman primates are regulated by both USFWS and CDC. However, the general feeling is that despite these overlapping regulatory authorities, things are working well at port locations. There is a concern that there may be issues with communication among the headquarters groups. Lack of consideration for policy implementation at the local level (i.e., port locations) is an issue that was raised by several interviewed CDC personnel. Often, CDC headquarters will issue a broad embargo policy (such as those on the importation of monkeys or civets), without any specific policies and guidance on roles, responsibilities, and interactions at the local level among the various agencies, namely, CBP, APHIS, and CDC. Leaving the details to be sorted out at the local level has often led to different and inconsistent implementing policies across the different quarantine stations. Also, in situations involving rush embargoes, time is of essence; having to spend time to sort out the details often leads to frustration at the local level. There is a need to establish plans and policies at the national level that can then filter down to the local level in a more consistent and efficient manner. CDC’s set of regulations on how to deal with

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health nonhuman primates and associated paperwork was identified as a good example that should be repeated for other animals and protocols. While specific policies are needed in roles and responsibilities, too-specific protocols can prove to be burdensome. Protocols for specific types of rodents instead of one broad rodent protocol are an example. Efficiencies can be gained with broader protocols. Agricultural Inspection Issues In a recent report, GAO indicated a concern that agricultural inspections at ports of entry have declined over the last 2 years while imports have increased. Data show a decline in the number of agricultural inspections at POEs nationwide from 40.9 million in FY 2002, when USDA was fully responsible for agricultural inspections, to 37.5 million in FY 2004, when DHS had primary responsibility (GAO, 2005). No clear explanation has been found as to why this drop in inspections occurred. Another concern is that the majority of live animals coming through ports get a cursory examination based on overall appearance of health. Only for select diseases are specific examinations or tests being done (e.g., for rabies), which can be done at import locations or before importation. Special Considerations in the Expansion of CDC Quarantine Stations Although there is a need for additional quarantine stations, the consensus is that it is an impractical idea at this point, since there are not even enough staff for existing stations. Rather, the first priority should be to hire new workers and expand the resources and capabilities at existing stations. Only when newly hired staff have gained enough experience and background should they be moved to staff new locations. Field inspection is more or less a hands-on learning experience. Staff can function only with adequate background and familiarity on the job. This is especially true with medical officers. It is stressed that new quarantine stations should never be opened with inexperienced inspectors and officers. There are also some suggestions that only ports with significant internationally arriving travelers be considered for the addition of a quarantine station. Further, only if additional funding is available should consideration of quarantine staff at airports with a primarily domestic traveling public be entertained. Another suggestion is that there should be differential levels of staffing for different locations depending on volume of importations. For examples, some ports might need just a single high-level person rather than several lower-level staff. There is a huge flow of freight from Canada and Mexico, and it is questioned whether these land borders are closely watched. Food, such as bush meat, may be imported through Canada to avoid the

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health authorities. Without staff on-site, these cases would be missed. Finally, a major expansion plan must take into consideration the fact that office space is at a premium at U.S. airports. REFERENCES Accord B, Administrator, APHIS. 2004. Animal and Plant Health Inspection Service. Statement at the March 4, 2004 hearing of the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, U.S. House of Representatives. APHIS (Animal and Plant Health Inspection Service, United States Department of Agriculture). 2003. APHIS Fact Sheet. The Animal and Plant Health Inspection Service and Department of Homeland Security: Working Together to Protect Agriculture. [Online] Available: http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/fs_aphis_homeland.pdf [accessed April 7, 2005]. APHIS. 2004a. Veterinary Services Safeguarding Animal Health: Import/Export. [Online] Available: http://www.aphis.usda.gov/vs/ncie/ [accessed March 1, 2004]. APHIS. 2004b. Veterinary Services Strategic Plan FY 2004 to FY 2008. [Online] Available: http://www.aphis.usda.gov/vs/pdf_files/strat_plan.pdf [accessed April 7, 2005]. Bonner RC, Commissioner, U.S. Customs and Border Protection. 2004. Statement of Robert C. Bonner to the National Commission on Terrorist Attacks Upon the United States. Statement at the January 26, 2004 hearing of the National Commission on Terrorist Attacks Upon the United States. Bush GW. 2002. Securing the Homeland, Strengthening the Nation. [Online] Available: http://www.whitehouse.gov/homeland/homeland_security_book.html [accessed April 7, 2005]. CBP (U.S. Customs and Border Protection, Department of Homeland Security). 2003. Customs and Border Protection Today. [Online] Available: http://www.cbp.gov/xp/CustomsToday/2003March/ [accessed March 31, 2004]. CBP. 2004. Preventing Animal and Plant Pests and Diseases: More than 1.7 Million Prohibited Agricultural Items Intercepted Last Year. [Online] Available: http://www.customs.gov/xp/cgov/newsroom/press_releases/0012004/01142004_4.xml [accessed April 2, 2004]. Crawford LM, Deputy Commissioner, FDA. 2003. Agroterrorism: The Threat to America’s Breadbasket. Statement at the November 19, 2003 hearing of the Committee on Homeland Security and Governmental Affairs, U.S. Senate. Creekmore L. 2003. Preventive Measures and Existing Regulations for Chronic Wasting Diseases in the U.S. Presentation at the September 10-11, 2003 Meeting on TSE in Animal Populations: Fact and Fiction, Fort Collins, CO. CRS (Congressional Research Service, The Library of Congress). 2004. Border Security: Inspection Practices, Policies, and Issues. [Online] Available: http://fpc.state.gov/documents/organization/33856.pdf [accessed April 7, 2005]. DGMQ (Division of Global Migration and Quarantine, National Center for Infectious Diseases, Centers for Disease Control and Prevention). 2003a. History of Quarantine. [Online] Available: http://www.cdc.gov/ncidod/dq/history.htm [accessed April 7, 2005]. DGMQ. 2003b. Mission. [Online] Available: http://wwwcdc.gov/ncidod/dq/mission.htm [accessed April 6, 2004]. DGMQ. 2004. Importation of Pets, Other Animals, and Animal Products into the United States. [Online] Available: http://www.cdc.gov/ncidod/dq/animal.htm [accessed March 18, 2004].

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health DHS (U.S. Department of Homeland Security). 2004a. Budget in Brief, Fiscal Year 2005. [Online] Available: http://www.dhs.gov/interweb/assetlibrary/FY_2005_BIB_4.pdf [accessed April 7, 2005]. DHS. 2004b. DHS Organization: Department Components. [Online] Available: http://www.dhs.gov/dhspublic/display?theme=9&content=2973 [accessed March 1, 2004]. DHS. 2004c. Protecting Against Agricultural Terrorism. [Online] Available: http://www.dhs.gov/dhspublic/display?theme=43&content=3117 [accessed April 2, 2004]. FASS (Federation of Animal Science Societies). 2003. No Retraining for Agricultural Inspectors in Border Agency Plan. [Online] Available: http://www.fass.org/fasstrack/news_item.asp?news_id=1646 [accessed April 6, 2004]. FCBF (Florida Customs Brokers & Forwarders Association, Inc.). 2003. CBP Agriculture Specialist Fact Sheet. [Online} Available: http://www.fcbf.com/NewsFlashDetail.asp?NewsId=47 [accessed April 4, 2004]. GAO (United States Government Accountability Office). 2005. Homeland Security: Much Is Being Done to Protect Agriculture from a Terrorist Attack, but Important Challenges Remain. GAO-05-214. Washington, DC: GAO. Grannis J. 2003. Animal Disease Outbreaks: 21st Century Issues. Presentation at the July 11, 2003 Conference on the Economic Impact of Animal Disease on the Food Marketing Sector, Denver, CO. Klein PN. 2005. Regulatory report: Game meat: A complex food safety and animal health issue. Food Safety Magazine 10(96). NRC (National Research Council). 2003. Countering Agricultural Bioterrorism. Washington, DC: National Academy Press. OMB (Office of Management and Budget, the Executive Office of the President of the United States). 2004a. Budget of the United States Government Fiscal Year 2005: Appendix. [Online] Available: http://www.whitehouse.gov/omb/budget/fy2005/appendix.html [accessed April 7, 2005]. OMB. 2004b. Department of Agriculture Part Assessments [Online] Available: http://www.whitehouse.gov/omb/budget/fy2005/pma/agriculture.pdf [accessed April 12, 2004]. OSH (Office of Health and Safety, Centers for Disease Control and Prevention). 2004. Etiologic Agent Import Permit Program. [Online] Available: http://www.cdc.gov/od/ohs/biosfty/imprtper.htm [accessed April 6, 2004]. PPQ. 2004. (Plant Protection and Quarantine, Animal and Plant Health Inspection Service, United States Department of Agriculture). Animal Product Manual (Second Edition). [Online] Available: http://www.aphis.usda.gov/ppq/manuals/pdf_files/APM.pdf [accessed April 7, 2005]. USAHA (United States Animal Health Association). 2003. USAHA 2003 Resolution No. 21. [Online] Available: http://www.usaha.org/resolutions/reso03/res-2103.html [accessed April 6, 2004]. USFWS (Division of Law Enforcement, US Fish and Wildlife Service). 2002. Annual Report FY 2001. [Online] Available: http://library.fws.gov/Pubs9/LEannual01.pdf [accessed April 7, 2005]. USFWS (Office of Law Enforcement, U.S. Fish and Wildlife Service). 2003. FY 2002 Annual Report. [Online] Available: http://www.fws.gov/le/pdffiles/FY2002rpt.pdf [accessed April 7, 2005].

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health APPENDIX 1—INTERVIEWED INDIVIDUALS Ahmad, Khawaja N. Supervisory VMO USDA-APHIS-VS, JFK Airport Akey, Dr. Bruce Acting State Veterinarian NYS Department of Agriculture & Markets Becker, Margaret Officer in Charge CDC NYC Quarantine Station Becker, Margaret Deputy Commissioner NYS Department of Agriculture & Markets Blumensaadt, Sena Acting Officer in Charge CDC Chicago Quarantine Station Ehart, Robert   National Association of State Departments of Agriculture Dailey, Terrence Officer in Charge CDC Atlanta Quarantine Station Dick, Jerre Associate Deputy USDA, APHIS, VS Drew, Anthony Officer in Charge CDC Miami Quarantine Station Dwyer, Susan Officer in Charge CDC San Francisco Quarantine Station Houck, Dr. Peter Quarantine Medical Officer CDC Seattle Quarantine Station Marty, Michael Officer in Charge CDC Los Angeles Quarantine Station Mitruka, Dr. Kiren Medical Officer CDC Miami Quarantine Station Riley, Lucinda Director of Agriculture DHS U.S. Customs and Border Protection Tapia, Dr. Robert Officer in Charge CDC Hawaii Quarantine Station Thomas, Lee Ann Director (Live Animal) USDA, APHIS, VS, NCIE APPENDIX 2—LINES OF INQUIRIES Inquiries for CDC Please describe the various personnel and their respective agencies involved with prevention/mitigation of public health threats originating from animals entering the United States through the U.S. quarantine stations. What are their specific roles and responsibilities? CDC’s Division of Global Migration and Quarantine (DGMQ): USDA/Animal Plant Health Inspection Service (APHIS): U.S. Customs and Border Protection (CBP): Immigration and Customs Enforcement (ICE) U.S. Fish and Wildlife Service (USFWS): Other personnel: What is the relationship between the APHIS staff with the CDC/DGMQ staff at our ports of entry? Is there a protocol for when Q-station CDC/DGMQ staff would call in the APHIS staff or vice versa? Are there challenges in implementing the above protocol?

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health What is the relationship between the CDC/DGMG staff with other agencies such as CBP, ICE, USFWS, etc…? Are there protocols from communication between CDC/DGMQ staff with other agencies, i.e. CBP, ICE, USFWS, etc…? Are there challenges in implementing the above protocol? What is the day-to-day reality of the work? For routine notification of imports For contraband What are the resources currently devoted to animal inspection activities at quarantine stations? Facility size in square feet _______ Number of animals facility can hold at any point in time_______ Laboratory capacity: _______ Human resources (Full Time Employees)_______ Are there barriers to successful protection of our borders from diseases in animals? If yes, what are these barriers? Human resources? Legal authority—overlapping authorities? Location capacity—need of additional Q-Stations? Other? Is there anything else of note? Additional Inquiries for the CBP and State Department of Agriculture Are there any written policies, procedures, manuals, and training given by the CDC to prevent the spread of zoonotic disease through live animals and animal products? How are responsibilities delegated among the different federal and state groups? How well mitigated are the threat of disease under current policy and do live animals or animal products pose the greater threat to the general population?

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health ABBREVIATIONS AMS Automated Manifest System APHIS Animal and Plant Health Inspection Service (USDA) APM Animal Product Manual AQI Agriculture Quarantine and Inspection (USDA APHIS) BTS Directorate of Border and Transportation Security (DHS) CBP U.S. Customs and Border Protection (DHS BTS) CDC Centers for Disease Control and Prevention CITES Convention on International Trade in Endangered Species of Wild Flora and Fauna DFO Director of Field Operations (DHS OFO) DGMQ Division of Global Migration and Quarantine (CDC NCID) DHHS U.S. Department of Health and Human Services DHS U.S. Department of Homeland Security DOI U.S. Department of the Interior DOJ U.S. Department of Justice EIS Epidemic Intelligence Service FAD foreign animal diseases FDA Food and Drug Administration FLETC Federal Law Enforcement Training Center FMD foot-and-mouth disease FSIS Food Safety and Inspection Service FTE full-time-employee HSA Homeland Security Act ICE Immigration and Customs Enforcement INA Immigration and Nationality Act INS U.S. Immigration and Naturalization Service (formerly DOJ, now DHS) IOM Institute of Medicine LSS Laboratories and Scientific Services (CBP) MOU Memorandum of Understanding NCID National Center for Infectious Diseases (CDC) NCIE National Center for Import and Export (USDA APHIS) NTC National Targeting Center (CBP OFO) OFO Office of Field Operations (DHS) POE Port of Entry PPQ Plant Protection and Quarantine (USDA APHIS) SARS severe acute respiratory syndrome SIV simian immunodeficiency virus USDA U.S. Department of Agriculture USFWS U.S. Fish and Wildlife Service VRS Veterinary Regulatory Support VS Veterinary Services (USDA APHIS)