F
International Legal Considerations for the Quarantine Station Expansion

Memorandum

To:

Committee on Measures to Enhance the Effectiveness of the CDC Quarantine Station Expansion Plan for U.S. Ports of Entry

From:

David P. Fidler (Consultant), Professor of Law and Harry T. Ice Faculty Fellow, Indiana University School of Law, Bloomington

Re:

International Legal Considerations for the Quarantine Station Expansion Plan

Date:

May 26, 2005

EXECUTIVE SUMMARY

The memorandum responds to the committee’s desire to understand the international legal considerations the federal government should have in mind as it develops its plans to expand the national quarantine system (NQS). The memorandum analyzes the basic dynamics of the relationship between public health and international law (Part 2); the revised International Health Regulations (IHR) adopted by the World Health Assembly on May 23, 2005 (Resolution WHA58.3) (Part 3); international trade law (Part 4); international human rights law (Part 5); and international legal issues connected with the expanded NQS, including stationing personnel and assets in foreign countries (Part 6). Attached to the memorandum are three annexes: a table compiling the positive and negative obligations international law imposes on the United States that may be germane to the



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Quarantine Stations at Ports of Entry: Protecting the Public’s Health F International Legal Considerations for the Quarantine Station Expansion Memorandum To: Committee on Measures to Enhance the Effectiveness of the CDC Quarantine Station Expansion Plan for U.S. Ports of Entry From: David P. Fidler (Consultant), Professor of Law and Harry T. Ice Faculty Fellow, Indiana University School of Law, Bloomington Re: International Legal Considerations for the Quarantine Station Expansion Plan Date: May 26, 2005 EXECUTIVE SUMMARY The memorandum responds to the committee’s desire to understand the international legal considerations the federal government should have in mind as it develops its plans to expand the national quarantine system (NQS). The memorandum analyzes the basic dynamics of the relationship between public health and international law (Part 2); the revised International Health Regulations (IHR) adopted by the World Health Assembly on May 23, 2005 (Resolution WHA58.3) (Part 3); international trade law (Part 4); international human rights law (Part 5); and international legal issues connected with the expanded NQS, including stationing personnel and assets in foreign countries (Part 6). Attached to the memorandum are three annexes: a table compiling the positive and negative obligations international law imposes on the United States that may be germane to the

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health expansion of the NQS (Annex 1); provision-by-provision analyses of the revised IHR (Annex 2) and the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) of the World Trade Organization (WTO) (Annex 3) in terms of their potential implications for the expansion of the NQS. In terms of the expansion of the NQS within the United States, none of the bodies of international law analyzed poses a significant constraint on the federal government’s expansion plans. International law recognizes each state’s sovereign right to take action to protect its public’s health. Expanding the NQS would constitute an exercise of that sovereign right. The areas of international law applicable to the expanded NQS analyzed in this memorandum involve disciplines on how the federal government exercises its sovereign right to protect public health. These disciplines address health measures that the expanded NQS would apply to people, goods (including plants and animals), containers used in international commerce, and means of transportation. The federal government’s strategy to make the NQS more comprehensive and robust in its capabilities to protect U.S. public health will bring the expanded NQS more directly and frequently into contact with these various bodies of international law. The United States public health system is already subject to the disciplines arising in international trade law (e.g., WTO and the SPS Agreement) and international human rights law, so organizing the expanded NQS to comply with these international legal rules will constitute continued U.S. compliance with its existing obligations under trade and human rights treaties. The most comprehensive set of disciplines the expanded NQS face appear in the revised IHR. The revised IHR will not enter into force for World Health Organization (WHO) member states that accept the new Regulations until 2007 (Article 59.2); but the United States has publicly announced its support for the revised IHR, meaning that the United States is unlikely to reject the revised IHR (Statement for the Record by the Government of the United States of America Concerning the World Health Organization’s Revised International Health Regulations, May 23, 2005 [hereinafter U.S. Statement for the Record]). The revised IHR are radically different from previous versions of the IHR and thus represent a historic international legal development of which the committee should be aware as part of its deliberations. In connection with possible plans to station U.S. public health personnel and assets in foreign countries as part of the expanded NQS, the memorandum outlines a number of international legal considerations that the committee should review in thinking about the wisdom of “forward deployment” of parts of the expanded NQS. In the context of “forward deployment,” international law is less accommodating to the United States because it would be operating from the sovereign territories of other states, which have superior

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health rights and obligations under international law concerning what happens in their territories. Stationing federal public health personnel and assets in other countries as part of the expanded NQS will have to involve cooperation with foreign governments and–in all likelihood–the negotiation of formal, written agreements governing the relationship between host governments and the U.S. public health presence in those countries. 1. INTRODUCTION The federal government of the United States plans to expand the national quarantine system (NQS), currently operated and managed by the Division of Global Migration and Quarantine of the Centers for Disease Control and Prevention (CDC). The federal government has long operated a national quarantine program to protect the United States against the introduction of communicable diseases from foreign countries and to prevent and control infectious disease spread between the states of the union. The federal government reduced the scale of the NQS in the 1970s when public health experts believed that the threat from communicable diseases had significantly diminished. Growing concerns in the last decade about emerging and reemerging infectious diseases and the threat of bioterrorism have prompted the federal government to develop plans to enhance the NQS to address the communicable disease threats posed to the United States today. The committee’s mandate is to review the federal government’s plans for expanding the NQS. As part of its review, the committee commissioned the Consultant to analyze the expansion of the NQS with respect to applicable international law. The committee believes that such an analysis will inform its deliberations of the international implications of the plans to expand the NQS. The United States will operate any expanded NQS in an environment affected by international law, making some understanding of this law pertinent to the committee’s overall mandate. 2. BASIC DYNAMICS OF INTERNATIONAL LAW WITH RESPECT TO PUBLIC HEALTH PROTECTION International law comprises the set of rules states have created to regulate their interactions with each other. For purposes of the international legal rules analyzed in this memorandum, the relevant actor is the United States. Typically, international legal analysis does not enquire into how constitutionally, or as a matter of domestic law, a state organizes itself to fulfill international legal obligations it has undertaken. As a federal system, the United States’ acceptance of international legal obligations is occasionally affected by federalism. The revised International Health Regulations (IHR) are a case in point because the United States has indicated that it will

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health have “to submit a narrowly tailored reservation … that will clarify that the United States will implement the IHRs in a manner consistent with our federal system of government” (U.S. Statement for the Record). Absent such reservations related to federalism, the United States cannot raise federalism as a reason for non-compliance with international legal obligations it has undertaken pursuant to treaties. Nor are questions of jurisdictional responsibilities within the federal government usually relevant for purposes of international legal analysis. Generally speaking, states have repeatedly acknowledged in international lawmaking that each state has a sovereign right to protect its territory and people from exogenous health threats moving in people, products, plants, or animals through the channels of world trade and travel. Thus, the desire of the federal government to strengthen its ability to protect the United States from communicable disease importation and spread does not, by itself, create any international legal problems because the United States has a sovereign right to engage in this governmental activity. International legal issues arise in this area because states have created various obligations and disciplines that regulate the manner in which they can exercise their sovereignty to protect public health. The United States is, for example, party to treaties that place limits and conditions on how it addresses potential public health threats posed by the global movement of people, animals, plants, and products. The United States is a party to various international trade agreements that regulate the exercise of U.S. sovereignty in protecting Americans from health threats from imported goods. The United States will need to operate its expanded NQS in conformity with existing and future U.S. obligations under applicable bodies of international law. The reduced scale of the NQS during that past three decades has meant that the NQS has not interfaced significantly with international law. The limited scope of international law on infectious disease control historically also contributed to the limited relationship between the NQS and international law. Expanding the scale, capabilities, and responsibilities of the NQS might bring it into more direct contact with international law, raising the profile of U.S. obligations under international law for the operation of the NQS. The three areas of treaty law most applicable to the expansion of the NQS are: (1) the international law directly addressing infectious disease control—the revised IHR promulgated by the World Health Organization (WHO); (2) international trade law; and (3) international human rights law. Protecting U.S. public health from disease threats will require taking action concerning people, products, animals, plants, and means of transport moving in the stream of international trade and travel. Although not exhaustive in terms of the possible international legal implications of an expanded NQS, analyzing the revised IHR, international trade law, and

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health international human rights law constitutes the best way to provide the committee with some perspective on the relationship between an expanded NQS and international law. This memorandum addresses each of these bodies of international law in turn. The United States will also face international legal issues if the federal government contemplates placing federal quarantine resources inside the territory of other countries. The Consultant understands that the federal government may wish to “forward deploy” public health assets to foreign ports and countries as part of the strategy to prevent and control the importation of potential health threats into the United States. Such arrangements will involve the United States negotiating agreements or arrangements with foreign countries in order to allow federal public health personnel to perform functions within the territory and jurisdiction of those sovereign nations. This memorandum contains brief commentary on the international legal issues that would arise with “forward deployment” of NQS assets in foreign countries. 3. THE INTERNATIONAL HEALTH REGULATIONS From their original promulgation by WHO as the International Sanitary Regulations in 1951, the old IHR constituted the only international legal instrument directly on infectious disease control binding on WHO member states. Prior to the revision in 2005, WHO last revised the IHR in 1981, when the organization removed smallpox from the list of the diseases subject to the Regulations. From 1981 until the present, the IHR have applied to only three diseases—cholera, plague, and yellow fever. The concerns about emerging and reemerging infectious diseases and bioterrorism behind the federal government’s plans to expand the NQS also stimulated at WHO a process to revise the IHR to make them more relevant to transnational disease threats in an era of globalization. This process began in 1995 and was completed by the World Health Assembly in May 2005 when it adopted the revised IHR. WHO’s adoption of the revised IHR, and the U.S. government’s declared support for the revised IHR, means that the federal government will develop the expanded NQS in an international legal environment affected by the revised IHR. The revised IHR contain an international legal regime radically different from the old IHR and their historical precursors. Most important from the perspective of an expanded NQS, the revised IHR impose more demanding international legal rules than any previous version of the IHR. For example, the more demanding nature of the revised IHR appears in the provision that defines “disease” in such a way that includes all sources of human illness or medical conditions (Article 1.1). This provision, and others, expands the revised IHR’s scope to include disease events caused by

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health biological, chemical, and radiological agents. Historically, the IHR applied only to communicable diseases, making the revised IHR’s application to public health threats from chemical and radiological sources a significant break from the past. In addition, the revised IHR’s scope creates international legal obligations for the United States not entirely encompassed by an expanded NQS, which would still be focused on communicable disease threats. The following sections summarize the key issues the revised IHR raise for the plans to expand the NQS. The length and complexity of the revised IHR means that this memorandum cannot mention each point at which the revised IHR and the expanded NQS might interface. For those members of the committee interested in more detail, Annex 2 provides a provision-by-provision analysis. Part I–Definitions, Purpose and Scope, Principles and Responsible Authorities Definitions The most important definition in the revised IHR for the expanded NQS is the definition of “disease” because this definition, as noted above, determines the scope of the revised IHR’s application. “Disease” is defined to mean “an illness of medical condition, irrespective of origin or source, that presents or could present significant harm to humans” (Article 1.1). Under this definition of disease, and the scope it implies for the revised IHR, the expanded NQS will not be sufficient to meet United States obligations under the revised IHR because the federal government is not expanding the NQS with chemical and radiological threats in mind. Purpose and Scope and Principles The purpose and scope of the revised IHR comport with the objectives of the expansion of the NQS—preventing, protecting against, controlling, and providing a public health response to the international spread of disease in ways that avoid unnecessary interference with international traffic and trade (Article 2). The principles that should guide the implementation of the revised IHR recognize that states have “the sovereign right to legislate and to implement legislation in pursuance of their health policies” (Article 3.4). The guiding principles of the revised IHR also importantly require that the IHR be implemented “with full respect for the dignity, human rights and fundamental freedoms of persons” (Article 3.1). This principle requires the expanded NQS to implement health measures against people in ways that comply with international human rights law, a requirement not previously contained in the IHR. Other principles of the revised

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health IHR also require states parties to the revised IHR to respect the dignity, human rights, and fundamental freedoms of persons (see Part 5 on international human rights law below). Responsible Authorities The revised IHR mandate that states parties designate a single, national contact point—the National IHR Focal Point—that plays an important role in the functioning of the revised IHR (Article 4.1). The expanded NQS would have to have an organizational and communication structure to facilitate U.S. compliance with the requirements of the administrative provisions of the revised IHR. Part II–Information and Public Health Response Core Surveillance and Response Capacities The old IHR had requirements for states parties to maintain certain public health capabilities at points of entry and exit, but the revised IHR contains surveillance and response capacity requirements that go far beyond anything seen in the history of the IHR. The revised IHR contain obligations for states parties to develop and strengthen core surveillance and response capacities specified in the text within five years from the entry into force of the revised IHR (Articles 5.1 and 13.1 and Annex 1). The objective is to move states parties to develop and maintain core public health capacities to identify, report, and respond effectively to public health risks and events that constitute public health emergencies of international concern. The capacities of the expanded NQS would be judged, thus, against the core capacity requirements established in the revised IHR. Notification of Disease Events The old IHR required states parties to report outbreaks of specific infectious diseases, namely cholera, plague, and yellow fever. The revised IHR adopts a different approach to disease notification because it requires notification not only of specific diseases (smallpox, polio, new subtypes of human influenza, and SARS) but also “all events which may constitute a public health emergency of international concern within its territory” (Article 6.1). States parties must also provide WHO with all relevant public health information if they have evidence of an unexpected or unusual public health event within their respective territories, irrespective of origin or source, which may constitute a public health emergency of international concern (Article 7).

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health BOX F.1 The Revised IHR’s Decision Instrument (Annex 2) Any case of smallpox, polio, human influenza caused by a new sub-type, and SARS must be notified to WHO under the revised IHR. For any event involving (1) cholera, pneumonic plague, yellow fever, viral haemorrhagic fevers (e.g., Ebola, Lassa, Marburg), West Nile fever, and other diseases that are of special national or regional concern (e.g., dengue fever, Rift Valley fever, and meningococcal disease), or (2) other incidents of potential international public health concern, including those of unknown causes or sources, States Parties shall answer the following questions, affirmative answers to at least two of which mean that the event shall be notified to WHO under the revised IHR: Is the public health impact of the event serious? Is the event unusual or unexpected? Is there a significant risk of international spread? Is there a significant risk of international travel or trade restrictions? Annex 2 provides examples for the application of these questions to disease events that are designed to assist the assessment and notification of events that may constitute a public health emergency of international concern. A key objective of the notification obligations is to ensure that global disease surveillance can identify, and respond to, new disease threats—of whatever origin—not captured by disease-specific reporting. Notification of disease events is to be guided by a “decision instrument” (Annex 2). See Box F.1 on how the decision instrument works. The expanded NQS would have to be able to utilize the decision instrument in order for the United States to fulfill its notification obligations under the revised IHR. WHO Surveillance and Verification Authorities Under the old IHR, WHO could only officially collect and disseminate epidemiological information supplied by governments. This limitation on WHO surveillance capabilities was a serious weakness of the past IHR. The revised IHR contain a number of provisions that increase WHO authority in the area of surveillance and information verification. Under the revised IHR, the WHO can collect and use epidemiological information from nongovernmental sources (Article 9.1), request verification from states parties of informed collected by WHO (Article 10.1), disseminate information it collects (Article 11), and determine whether an event constitutes a public health emergency of international concern (Article 12).

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health Taken together, these new authorities for WHO in the revised IHR create an environment for the expanded NQS radically different from the way in which international surveillance and WHO operated under the old IHR. The expanded NQS might have to be involved in cooperating with WHO in verifying information WHO has received about disease events in the United States, assessing a greater stream of surveillance information disseminated by WHO, and interacting with WHO when WHO makes determinations about whether an event in the United States constitutes a public health emergency of international concern. Part III–Recommendations Another new feature of the revised IHR is granting WHO the authority to issue temporary recommendations in connection with public health emergencies of international concern and standing recommendations with respect to health measures needed for routine or periodic application (Articles 15 and 16). The revised IHR provide examples of the kinds of measures WHO could recommend (Article 18) and the criteria that should guide the WHO in issuing recommendations (Article 17). Recommendations issued by WHO under the revised IHR would not be legally binding on the United States, so the issuance of recommendations would not obligate the expanded NQS to act in accordance with WHO guidance. If the United States agreed to implement WHO recommendations, then the expanded NQS would be engaged in such implementation. To implement WHO recommendations effectively, the expanded NQS would need both the domestic legal authority to act as specified in the recommendations and the capacity to so act. In addition, U.S. implementation of WHO recommendations concerning goods would have to comply with U.S. obligations under international trade law. Part IV–Points of Entry The expansion of the NQS involves increasing federal public health capabilities at more points of entry into the United States, which makes the provisions in the revised IHR on points of entry particularly relevant. The revised IHR contain numerous obligations for states parties with respect to capacities and measures taken at points of entry. These obligations include ensuring that designated points of entry have capacities detailed in the revised IHR; identifying the competent authorities for points of entry; furnishing to WHO information on potential public health threats at points of entry; issuing health documents to ships in accordance with requirements in the revised IHR; maintaining sanitary facilities for travelers at points of entry; supervising deratting, disinfection, disinsection, or decontamination

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health of conveyances, containers, cargo, or goods or the application of health measures for persons at points of entry; and others. To comply with these kinds of obligations in the revised IHR, the United States would need to ensure that the expanded NQS is authorized under domestic law and actually capable of undertaking the many duties the revised IHR create for the competent authorities at points of entry. Although the revised IHR contain point-of-entry obligations that resemble duties found in the old IHR, the expansion of the NQS means that the number of places at which these obligations may have direct effect will increase. Part V–Public Health Measures The revised IHR contain many rules on the application of health measures to travelers; conveyances and conveyance operators; goods, containers, and container loading areas. These rules generally attempt to balance a state party’s right to apply health measures to protect its public health with the objectives of minimizing interference with travelers and international traffic. The expanded NQS would be required to operate these rules, and thus these provisions of the revised IHR are important in terms of planning for the expanded NQS. The following paragraphs provide some sense of the kinds of rules on health measures that the revised IHR impose on the United States and its expanded NQS. Health Measures for Travelers General principles The revised IHR allow states parties to apply health measures on the arrival or departure of travelers, but the provisions on health measures for travelers place disciplines on the content and implementation of such measures. To begin, the revised IHR state that one of their guiding principles is the implementation of the IHR with full respect for dignity, human rights, and fundamental freedoms of persons (Article 3.1). The revised IHR give this general principle more context by requiring respect for dignity, human rights, and fundamental freedoms through treating all travelers with courtesy and respect, taking into consideration gender, sociocultural, ethnic, or religious concerns of travelers, and providing adequate food, water, shelter, protection for possessions, means of communication, and medical treatment for those quarantined, isolated, or subject to other measures for public health purposes (Article 32). Other provisions of the revised IHR apply these general requirements in specific contexts that would implicate the

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health operation of the expanded NQS. The following paragraphs describe some of these provisions. Medical examinations States parties to the revised IHR are allowed to require arriving or departing travelers to undergo a “non-invasive medical examination which is the least intrusive examination that would achieve the public health objective” (Article 23.1[a][iii]). As a general matter, the revised IHR prohibit states parties from requiring invasive medical examination as a condition of entry for travelers (Article 31.1). If the state party believes that an invasive medical examination is necessary on the basis of evidence of a public health risk, then it can perform such examination provided that it is “the least intrusive and invasive medical examination that would achieve the public health objective of preventing the international spread of disease” (Article 23.2; see also Article 43.1). A state party can administer no medical examination without the prior, express informed consent of the traveler (Article 23.3), except in circumstances under which the protection of public health warrants compulsory medical examination, in which case such examination must be the least intrusive and invasive examination possible to achieve the public health objective (Article 31.2). Refusal to consent to medical examination can be grounds for denying entry to the traveler (Article 31.2). Vaccination or other prophylaxis As a general matter, the revised IHR prohibits states parties from requiring vaccination or other prophylaxis as a condition of entry for any traveler (Article 31.1). The revised IHR create, however, some exceptions. First, states parties can create vaccination or other prophylaxis requirements for people seeking temporary or permanent residence (Article 31.1[b]). Second, proof of vaccination against yellow fever may be required for travelers as a condition of entry to a state party (Article 31.1[c] and Annex 7). Third, a state party may require vaccination or other prophylaxis as a condition of entry for a traveler if recommended by WHO as a temporary or standing recommendation under the revised IHR. Fourth, a state party may require vaccination or other prophylaxis as a condition of entry for travelers if the state party believes that such a requirement is warranted because of an imminent public health risk (Article 31.2[b]). A state party can administer no vaccination or other prophylaxis without the prior, express informed consent of the traveler (Article 23.3), except in circumstances under which the protection of public health warrants compulsory vaccination or other prophylaxis (Article 31.2). Refusal

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health Article of the SPS Agreement Implications for the Plans to Expand the National Quarantine System (NQS)   guideline or recommendation as a condition for import, the Member should provide an indication of the reason therefor, and, in particular, whether it considers that the standard is not stringent enough to provide the appropriate level of sanitary or phytosanitary protection. If a Member revises its position, following its indication of the use of a standard, guideline or recommendation as a condition for import, it should provide an explanation for its change and so inform the Secretariat as well as the relevant international organizations, unless such notification and explanation is given according to the procedures of Annex B. In order to avoid unnecessary duplication, the Committee may decide, as appropriate, to use the information generated by the procedures, particularly for notification, which are in operation in the relevant international organizations. The Committee may, on the basis of an initiative from one of the Members, through appropriate channels invite the relevant international organizations or their subsidiary bodies to examine specific matters with respect to a particular standard, guideline or recommendation, including the basis of explanations for non-use given according to paragraph 4. The Committee shall review the operation and implementation of this Agreement three years after the date of entry into force of the WTO Agreement, and thereafter as the need arises. Where appropriate, the Committee may submit to the Council for Trade in Goods proposals to amend the text of this Agreement having regard, inter alia, to the experience gained in its implementation.  

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health Article 13 Implementation   Members are fully responsible under this Agreement for the observance of all obligations set forth herein. Members shall formulate and implement positive measures and mechanisms in support of the observance of the provisions of this Agreement by other than central government bodies. Members shall take such reasonable measures as may be available to them to ensure that non-governmental entities within their territories, as well as regional bodies in which relevant entities within their territories are members, comply with the relevant provisions of this Agreement. In addition, Members shall not take measures which have the effect of, directly or indirectly, requiring or encouraging such regional or nongovernmental entities, or local governmental bodies, to act in a manner inconsistent with the provisions of this Agreement. Members shall ensure that they rely on the services of non-governmental entities for implementing sanitary or phytosanitary measures only if these entities comply with the provisions of this Agreement. This provision is important for the expanded NQS because it reiterates that the SPS Agreement’s provisions are obligations that must be observed. The expanded NQS will become an important component of how the United States complies with its duties under the SPS Agreement. Article 14 Final Provisions   The least-developed country Members may delay application of the provisions of this Agreement for a period of five years following the date of entry into force of the WTO Agreement with respect to their sanitary or phytosanitary measures affecting importation or imported products. Other developing country Members may delay application of the provisions of this Agreement, other than paragraph 8 of Article 5 and Article 7, for two years following the date of entry into force of the WTO Agreement with respect to their existing sanitary or phytosanitary measures affecting importation or imported products, where such application is prevented by a lack of technical expertise, technical infrastructure or resources. This provision does not apply to the United States.

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health Article of the SPS Agreement Implications for the Plans to Expand the National Quarantine System (NQS) ANNEX A: DEFINITIONSc Sanitary or phytosanitary measure—any measure applied: to protect animal or plant life or health within the territory of the Member from risks arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or disease-causing organisms; to protect human or animal life or health within the territory of the Member from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs; to protect human life or health within the territory of the Member from risks arising from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests; or to prevent or limit other damage within the territory of the Member from the entry, establishment or spread of pests. Sanitary or phytosanitary measures include all relevant laws, decrees, regulations, requirements and procedures including, inter alia, end product criteria; processes and production methods; testing, inspection, certification and approval procedures; quarantine treatments including relevant requirements associated with the transport of animals or plants, or with the materials necessary for their survival during transport; provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and labelling requirements directly related to food safety. This annex defines many of the important terms and concepts that are at the heart of obligations in the SPS Agreement, including definitions of what constitutes a SPS measure; what counts as an international standard, guideline, or recommendation; and what “risk assessment” means. These definitions will be important to the expanded NQS’ compliance with the SPS Agreement.

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health   Harmonization—The establishment, recognition and application of common sanitary and phytosanitary measures by different Members. International standards, guidelines and recommendations for food safety, the standards, guidelines and recommendations established by the Codex Alimentarius Commission relating to food additives, veterinary drug and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practice; for animal health and zoonoses, the standards, guidelines and recommendations developed under the auspices of the International Office of Epizootics; for plant health, the international standards, guidelines and recommendations developed under the auspices of the Secretariat of the International Plant Protection Convention in cooperation with regional organizations operating within the framework of the International Plant Protection Convention; and for matters not covered by the above organizations, appropriate standards, guidelines and recommendations promulgated by other relevant international organizations open for membership to all Members, as identified by the Committee. Risk assessment—The evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the sanitary or phytosanitary measures which might be applied, and of the associated potential biological and economic consequences; or the evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs.  

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health Article of the SPS Agreement Implications for the Plans to Expand the National Quarantine System (NQS) Appropriate level of sanitary or phytosanitary protection—The level of protection deemed appropriate by the Member establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health within its territory. NOTE: Many Members otherwise refer to this concept as the “acceptable level of risk.” Pest- or disease-free area—An area, whether all of a country, part of a country, or all or parts of several countries, as identified by the competent authorities, in which a specific pest or disease does not occur. NOTE: A pest- or disease-free area may surround, be surrounded by, or be adjacent to an area—whether within part of a country or in a geographic region which includes parts of or all of several countries—in which a specific pest or disease is known to occur but is subject to regional control measures such as the establishment of protection, surveillance and buffer zones which will confine or eradicate the pest or disease in question. Area of low pest or disease prevalence—An area, whether all of a country, part of a country, or all or parts of several countries, as identified by the competent authorities, in which a specific pest or disease occurs at low levels and which is subject to effective surveillance, control or eradication measures.  

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health ANNEX B: TRANSPARENCY OF SANITARY AND PHYTOSANITARY REGULATIONS This annex provides the detailed obligations for making sure the application of SPS measures by WTO members is transparent. These rules would apply to the operation of the expanded NQS in each of the areas identified: publication of regulations, inquiry points, and notification procedures. Publication of regulations   Members shall ensure that all sanitary and phytosanitary regulationsd which have been adopted are published promptly in such a manner as to enable interested Members to become acquainted with them. Except in urgent circumstances, Members shall allow a reasonable interval between the publication of a sanitary or phytosanitary regulation and its entry into force in order to allow time for producers in exporting Members, and particularly in developing country Members, to adapt their products and methods of production to the requirements of the importing Member. Enquiry points   Each Member shall ensure that one enquiry point exists which is responsible for the provision of answers to all reasonable questions from interested Members as well as for the provision of relevant documents regarding: any sanitary or phytosanitary regulations adopted or proposed within its territory; any control and inspection procedures, production and quarantine treatment, pesticide tolerance and food additive approval procedures, which are operated within its territory; risk assessment procedures, factors taken into consideration, as well as the determination of the appropriate level of sanitary or phytosanitary protection; the membership and participation of the Member, or of relevant bodies within its territory, in international and

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health Article of the SPS Agreement Implications for the Plans to Expand the National Quarantine System (NQS)   regional sanitary and phytosanitary organizations and systems, as well as in bilateral and multilateral agreements and arrangements within the scope of this Agreement, and the texts of such agreements and arrangements. Members shall ensure that where copies of documents are requested by interested Members, they are supplied at the same price (if any), apart from the cost of delivery, as to the nationalse of the Member concerned.   Notification procedures     Whenever an international standard, guideline or recommendation does not exist or the content of a proposed sanitary or phytosanitary regulation is not substantially the same as the content of an international standard, guideline or recommendation, and if the regulation may have a significant effect on trade of other Members, Members shall: publish a notice at an early stage in such a manner as to enable interested Members to become acquainted with the proposal to introduce a particular regulation; notify other Members, through the Secretariat, of the products to be covered by the regulation together with a brief indication of the objective and rationale of the proposed regulation. Such notifications shall take place at an early stage, when amendments can still be introduced and comments taken into account; provide upon request to other Members copies of the proposed regulation and, whenever possible, identify the parts which in substance deviate from international standards, guidelines or recommendations;  

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health   without discrimination, allow reasonable time for other Members to make comments in writing, discuss these comments upon request, and take the comments and the results of the discussions into account. However, where urgent problems of health protection arise or threaten to arise for a Member, that Member may omit such of the steps enumerated in paragraph 5 of this Annex as it finds necessary, provided that the Member: immediately notifies other Members, through the Secretariat, of the particular regulation and the products covered, with a brief indication of the objective and the rationale of the regulation, including the nature of the urgent problem(s); provides, upon request, copies of the regulation to other Members; allows other Members to make comments in writing, discusses these comments upon request, and takes the comments and the results of the discussions into account. Notifications to the Secretariat shall be in English, French or Spanish. Developed country Members shall, if requested by other Members, provide copies of the documents or, in case of voluminous documents, summaries of the documents covered by a specific notification in English, French or Spanish. The Secretariat shall promptly circulate copies of the notification to all Members and interested international organizations and draw the attention of developing country Members to any notifications relating to products of particular interest to them. Members shall designate a single central government authority as responsible for the implementation, on the national level, of the provisions concerning notification procedures according to paragraphs 5, 6, 7 and 8 of this Annex.  

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health Article of the SPS Agreement Implications for the Plans to Expand the National Quarantine System (NQS) General reservations     Nothing in this Agreement shall be construed as requiring: the provision of particulars or copies of drafts or the publication of texts other than in the language of the Member except as stated in paragraph 8 of this Annex; or Members to disclose confidential information which would impede enforcement of sanitary or phytosanitary legislation or which would prejudice the legitimate commercial interests of particular enterprises.   ANNEX C CONTROL, INSPECTION AND APPROVAL PROCEDURESf This annex applies obligations concerning how WTO members implement control, inspection, and approval procedures with respect to products subject to SPS measures. These duties would affect the way in which the expanded NQS operates because the expanded NQS will be involved with control, inspection, and approval actions concerning products that might pose health threats.   Members shall ensure, with respect to any procedure to check and ensure the fulfilment of sanitary or phytosanitary measures, that: such procedures are undertaken and completed without undue delay and in no less favourable manner for imported products than for like domestic products; the standard processing period of each procedure is published or that the anticipated processing period is communicated to the applicant upon request; when receiving an application, the competent body promptly examines the completeness of the documentation and informs the applicant in a precise and complete manner of all deficiencies; the competent body transmits as soon as possible the results of the procedure in a precise and complete manner to the applicant so that corrective action may be taken if necessary; even when the

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health   application has deficiencies, the competent body proceeds as far as practicable with the procedure if the applicant so requests; and that upon request, the applicant is informed of the stage of the procedure, with any delay being explained; information requirements are limited to what is necessary for appropriate control, inspection and approval procedures, including for approval of the use of additives or for the establishment of tolerances for contaminants in food, beverages or feedstuffs; the confidentiality of information about imported products arising from or supplied in connection with control, inspection and approval is respected in a way no less favourable than for domestic products and in such a manner that legitimate commercial interests are protected; any requirements for control, inspection and approval of individual specimens of a product are limited to what is reasonable and necessary; any fees imposed for the procedures on imported products are equitable in relation to any fees charged on like domestic products or products originating in any other Member and should be no higher than the actual cost of the service; the same criteria should be used in the siting of facilities used in the procedures and the selection of samples of imported products as for domestic products so as to minimize the inconvenience to applicants, importers, exporters or their agents; whenever specifications of a product are changed subsequent to its control and inspection in light of the applicable regulations, the procedure for the modified product is limited to what is necessary to determine whether adequate confidence exists that the product still meets the regulations concerned; and  

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Quarantine Stations at Ports of Entry: Protecting the Public’s Health Article of the SPS Agreement Implications for the Plans to Expand the National Quarantine System (NQS) a procedure exists to review complaints concerning the operation of such procedures and to take corrective action when a complaint is justified. Where an importing Member operates a system for the approval of the use of food additives or for the establishment of tolerances for contaminants in food, beverages or feedstuffs which prohibits or restricts access to its domestic markets for products based on the absence of an approval, the importing Member shall consider the use of a relevant international standard as the basis for access until a final determination is made. Where a sanitary or phytosanitary measure specifies control at the level of production, the Member in whose territory the production takes place shall provide the necessary assistance to facilitate such control and the work of the controlling authorities. Nothing in this Agreement shall prevent Members from carrying out reasonable inspection within their own territories.   aFor the purposes of paragraph 3 of Article 3, there is a scientific justification if, on the basis of an examination and evaluation of available scientific information in conformity with the relevant provisions of this Agreement, a Member determines that the relevant international standards, guidelines or recommendations are not sufficient to achieve its appropriate level of sanitary or phytosanitary protection. bFor purposes of paragraph 6 of Article 5, a measure is not more trade-restrictive than required unless there is another measure, reasonably available taking into account technical and economic feasibility, that achieves the appropriate level of sanitary or phytosanitary protection and is significantly less restrictive to trade. cFor the purpose of these definitions, “animal” includes fish and wild fauna; “plant” includes forests and wild flora; “pests” include weeds; and “contaminants” include pesticide and veterinary drug residues and extraneous matter. dSanitary and phytosanitary measures such as laws, decrees or ordinances which are applicable generally. eWhen “nationals” are referred to in this Agreement, the term shall be deemed, in the case of a separate customs territory Member of the WTO, to mean persons, natural or legal, who are domiciled or who have a real and effective industrial or commercial establishment in that customs territory. fControl, inspection and approval procedures include, inter alia, procedures for sampling, testing, and certification.