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
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
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
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
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
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
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).
BOX F.1 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:
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).
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
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
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
to consent to vaccination or other prophylaxis can be grounds for a state party to deny entry to the traveler (Article 31.2). Travelers subjected to vaccination or other prophylaxis must be informed of all risks associated with these actions (Article 23.4), and the administration of the vaccination or other prophylaxis must conform to established national or international safety guidelines in order to minimize risk to the traveler (Article 23.5).
Quarantine and isolation
A state party may use quarantine and isolation as health measures against travelers arriving or departing in two circumstances: (1) if WHO recommends quarantine and isolation as health measures needed to address a public health emergency of international concern; and (2) if the state party itself determines that quarantine and isolation are health measures justified under the circumstances to address a public health risk (Articles 23.2, 31.2[c], and 43.1). A state party must obtain the prior, express informed consent of the traveler before implementing quarantine or isolation on such persons (Article 23.3), unless the state party has grounds to believe that compulsory quarantine and isolation are required to address an imminent public health risk (Article 31.2[c]). A state party that places persons in quarantine or isolation must provide persons with, or arrange for the provision of, adequate food, water, shelter, clothing, security for possessions, medical treatment, and access to communications (Article 32).
Public health observation
States parties may place suspect travelers under public health observation pursuant to their own determinations (Articles 23.2, 30, and 31.2[c]) or WHO recommendations, but this health measure also requires the prior, express informed consent of the traveler in question (Article 23.3), unless the state party believes that compulsory public health observation is required to protect public health (Article 31.2[c]). A state party may allow a suspect traveler under public health observation to continue on an international voyage if (a) the traveler does not pose an imminent threat to public health, and (b) the state party informs the competent authority of the travelers next point of entry (Article 30).
Personal information
States parties may require as a condition of entry for travelers certain information about the travelers’ itinerary and destination and the oppor-
tunity to review health documents required under the revised IHR (e.g., yellow fever vaccination certificate) (Article 23.2[a][i]-[ii]). Refusal to provide this information can be grounds for the state party to deny entry to the traveler (Article 31.2). The revised IHR contain provisions imposing obligations on states parties to keep confidential health information collected or received pursuant to the implementation of the revised IHR, except in cases in which a state party must disclose or transmit personal information for the purposes of assessing and managing a public health risk (Article 45).
Health Measures for Goods and Cargo
The revised IHR’s general principle concerning health measures applied against goods and cargo is that states parties should avoid unnecessary interference with international traffic and trade (Articles 2 and 43.1). States parties may inspect goods and cargo for public health purposes on arrival or departure, subject to relevant articles of the revised IHR and applicable international agreements (Article 23.1[b]). The revised IHR define “goods” to mean “tangible products, including animals and plants, transported on an international voyage, including for utilization on board a conveyance” (Article 1.1). “Cargo” is defined as “goods carried on a conveyance or in a container” (Article 1.1).
States parties may apply health measures to goods and cargo beyond inspection “in accordance with the Regulations” (Article 23.2). The revised IHR prohibit states parties applying health measures (e.g., detention, quarantine) to goods (other than live animals) in transit without transshipment (Article 33), except when (1) states parties believe that such measures are necessary to address a public health risk, in which case the measures “shall not be more restrictive of international traffic … than reasonably available alternatives that would achieve the appropriate level of health protection” (Article 43.1); (2) WHO recommends such measures to address a public health risk or public health emergency of international concern (Articles 15 and 16); and (3) applicable international agreements (e.g., international trade agreements) permit such measures (Article 33).
Beyond the prohibition of additional measures on goods (other than live animals) in transit without transshipment, the revised IHR contains no more special provisions for goods and cargo. For goods and cargo entering the territory of a state party, the revised IHR do not contain the kind of detailed rules present for the treatment of travelers. The revised IHR’s approach to goods and cargos highlights the importance of international trade law for health measures that may affect the flow of products in international commerce (see Part 4 below).
WHO may make recommendations to states parties about the health measures they should apply to goods and cargo (Articles 15 and 16), but these recommendations are not binding on states parties. A state party may apply a health measure to goods and cargo that achieves a greater level of protection than a WHO recommendation when it believes the protection of its public health justifies such a measure (Article 43.1). Any such measure shall not be more restrictive of international traffic than reasonably available alternatives that would achieve the appropriate level of health protection (Article 43.1).
Health Measures for Conveyances
General principles
The revised IHR’s general principle concerning health measures applied against conveyances is that states parties should avoid unnecessary interference with international traffic and trade (Article 2). States parties may inspect conveyances for public health purposes on arrival or departure, subject to relevant articles of the revised IHR and applicable international agreements (Article 23.1[b]). The revised IHR define “conveyance” to mean “an aircraft, ship, train, road vehicle or other means of transport, on an international voyage” (Article 1.1).
States parties may apply health measures to conveyances beyond inspection on the basis of evidence of a public health risk “in accordance with these Regulations” (Article 23.2). WHO may make recommendations to states parties about the health measures they should apply to conveyances (Articles 15 and 16), but these recommendations are not binding on states parties. A state party may apply a health measure to a conveyance that achieves a greater level of protection than a WHO recommendation when (a) it believes the protection of its public health justifies such a measure; and (b) other applicable international agreements permit it do so (Article 43.1).
Specific rules
In addition to general principles about health measures for conveyances, the revised IHR contain “special provisions” concerning conveyances and conveyance operators (Articles 24-29 and Annexes 4 and 5). These rules are too numerous and detailed to describe here, but they constitute important provisions for the expanded NQS because it will be involved in the public health management of conveyances arriving and departing the United States.
Generally, the special provisions contain rules that, among other things, (1) prohibit states parties from taking certain actions against conveyances,
with specified exceptions (Articles 25 [Ships and Aircraft in Transit] and Article 28 [Ships and Aircraft at Points of Entry]; (2) provide guidance for action states parties may take (Article 27 [Affected Conveyances]); and (3) impose positive obligations on states parties with respect to health measures and conveyances (Annex 4, §B [duty not to damage conveyances during the application of health measures]; Annex 5, ¶4 [establishment of vector control programs at points of entry and exit]).
Health Measures for Containers and Container Loading Areas
The revised IHR’s general principle concerning health measures applied to containers used to ships goods and cargo on conveyances is that states parties should avoid unnecessary interference with international traffic (Article 2). States parties may inspect containers for public health purposes on arrival or departure, subject to relevant articles of the revised IHR and applicable international agreements (Article 23.1[b]). States parties may apply health measures to conveyances beyond inspection on the basis of evidence of a public health threat “in accordance with these Regulations” (Article 23.2).
WHO may make recommendations to states parties about the health measures they should apply to containers (Articles 15 and 16), but these recommendations are not binding on states parties. A state party may apply a health measure to a container that achieves a higher level of protection than a WHO recommendation when (a) it believes the protection of its public health justifies such a measure; and (b) other applicable international agreements permit it do so (Article 43.1). The revised IHR also impose on states parties positive obligations to ensure that containers and container loading areas are kept free from sources of infection or contamination (Article 34 and Annex 5, ¶4).
Part VI–Health Documents
As part of the effort to avoid unnecessary interference with international traffic, the revised IHR contain rules regulating what health documents states parties can require. The general principle is that “[n]o health documents, other than those provided for under these Regulations or in recommendations issued by WHO, shall be required in international traffic” (Article 35). The revised IHR recognize the following as health documents that states parties can require: yellow fever vaccination certificate (Annex 7); vaccination or other prophylaxis certificates relating to WHO-recommended vaccinations or prophylaxis (Annex 6); Maritime Declaration of Health (Article 37 and Annex 8); Health Part of the General Aircraft Declaration (Article 38 and Annex 9); and Ship Sanitation Control Exemp-
tion Certificate and Ship Sanitation Control Certificate (Article 39 and Annex 3).
The revised IHR’s prohibition on health documents other than those recognized by the revised IHR or recommended by WHO does not apply to other health document requirements (1) applied to travelers seeking temporary or permanent residence; and (2) concerning the public health status of goods or cargo in international trade pursuant to applicable international agreements (Article 35). The general provision that allows additional health measures (Article 43) does not appear to permit states parties to require additional health documents other than those recognized by the revised IHR or recommended by WHO.
Part VII–Charges
The revised IHR prohibit states parties from charging travelers for medical examinations, vaccinations, other prophylaxis, quarantine, isolation, for certificates detailing a traveler’s arrival and departure dates, and any health measures applied to the traveler’s baggage (Article 40.1). States parties may charge for other health measures (Article 40.2) in accordance with specific criteria (Article 40.3). The revised IHR also contain rules on charges made for applying health measures to baggage, cargo, containers, conveyances, goods, or postal parcels (Article 41).
Part VIII–General Provisions
The revised IHR contains a number of what it calls “general provisions,” which comprise a host of rules that are not necessarily connected with each other in terms of their subject matter. This memorandum has already mentioned two of these general provisions (Articles 43 [Additional Health Measures] and Article 45 [Treatment of Personal Data]). The other general provisions in this part of the revised IHR respectively involve (1) a requirement to initiate and complete all health measures under the Regulations without delay and in a transparent and nondiscriminatory manner (Article 42); (2) a duty to collaborate with other states parties to facilitate the implementation of the revised IHR (Article 44); and (3) an obligation to facilitate the transport, entry, exit, processing and disposal of specimens, reagents, and other diagnostic materials for verification and response purposes under the revised IHR (Article 46).
Article 43 on additional health measures deserves some specific attention. This provision allows states parties to apply health measures that (1) achieve the same or greater level of health protection than measures recommended by WHO under the revised IHR; or (2) are otherwise prohibited by specific rules of the revised IHR (Article 43.1). For example, under Article
43.1, a state party may impose a health measure on travelers that achieves the same or greater level of health protection than WHO has recommended or that is otherwise prohibited under specific articles of the revised IHR, provided the state party satisfies the conditions laid out in the article. The provision is important because it reflects the state’s sovereign right to take action to protect its public health, even in the face of different advice from WHO.
Applying additional health measures under Article 43.1 requires, however, the state party to satisfy certain disciplines on its sovereignty. First, states parties must base any such additional health measures on scientific principles and available scientific evidence of a risk to human health or, if scientific evidence is insufficient, on available information, including information from WHO and other international organizations (Article 43.2). In addition, all such additional health measures cannot be (1) more restrictive of international traffic or (2) more intrusive or invasive to persons than reasonably available alternative measures that would achieve the level of health protection sought (Article 43.1). This dynamic echoes a similar set of rules in international trade law and international human rights law (see Parts 4 and 5 below).
A state party applying additional measures pursuant to Article 43.1 that significantly interfere with international traffic is also required (1) to provide WHO the public health rationale and scientific information supporting such measures (Article 43.3); and (2) to review the measures within three months to assess whether the measures remain appropriate (Article 43.6). WHO may ask the state party to cease application of its additional health measures (Article 43.4), and states parties affected by the additional measures may seek consultations about them (Article 43.7).
Article 43 is important for the expanded NQS because (1) it allows states parties to adopt health measures that are more protective of public health than some measures provided for in the revised IHR or recommended by WHO, provided these measures have a scientific basis and are not more restrictive/intrusive than necessary to achieve the public health objective; and (2) it establishes a process of international scientific, trade, and human rights scrutiny of such additional measures. Article 43 represents yet another example of the revised IHR attempting to balance the sovereign right to protect public health with disciplines on the exercise of such public health sovereignty.
Part IX–The IHR Roster of Experts, the Emergency Committee, and the Review Committee and Part X–Final Provisions
The last two parts of the revised IHR require less attention in terms of the plans to expand the NQS. Part IX (Articles 47–53) establishes the
bodies and procedures that will be needed to operate the various mechanisms of the revised IHR. For example, the Emergency and Review Committees are needed to advise the Director-General on the issuance of temporary and standing recommendations respectively (Articles 15 and 16). The Emergency Committee also advises the Director-General on whether a disease event constitutes a public health emergency of international concern (Article 12.2).
The United States would utilize input from the expanded NQS in its dealings in the Emergency and Review Committees; and the work of these committees is important to the overall functioning of the revised IHR. Participating in these bodies and processes will not, however, be a day-to-day function of the expanded NQS, nor will the federal government view these bodies and procedures as important in contemplating what capabilities the expanded NQS needs to fulfill its mandate. Therefore, neither this memorandum nor its Annex 2 analyzes these parts of the revised IHR.
The last part of the revised IHR—the “Final Provisions” (Articles 54–66)—also does not merit detailed discussion in this memorandum because it mainly contains technical international legal matters (e.g., amendments to the IHR, relationship with other international agreements, rejection and reservations, entry into force, etc.) not directly relevant to the committee’s focus on the capabilities required for the expanded NQS.
Summary on the Proposed Revision of the International Health Regulations
The revised IHR is very important for the plans to expand the NQS. The seminal nature of the content of the revised IHR, combined with U.S. government support for these new rules, means that the international legal environment in which the expanded NQS will function will be shaped significantly by the revised IHR. The revised IHR’s rules address, in some way, the exercise of virtually every public health function the federal government would task the expanded NQS to fulfill—disease surveillance, notification, and reporting; surveillance and response capacity building; monitoring travelers; dealing with suspect and infected passengers (vaccination, prophylaxis, quarantine, isolation, observation); inspecting goods, cargo, and conveyances; ensuring points of entry and exit are free of disease and disease vectors and reservoirs; issuing health documents to conveyances; and cooperating and collaborating with other governments and international organizations. No other body of international law will have the impact on the expanded NQS that the revised IHR will have.
4. INTERNATIONAL TRADE LAW
The second important area of treaty law applicable to the expansion of the NQS is international trade law. The United States is party to many international trade agreements at the multilateral, regional, and bilateral levels. For purposes of this memorandum, the Consultant has focused on agreements within the WTO, namely the General Agreement on Tariffs and Trade (GATT), the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), and the General Agreement on Trade in Services (GATS). Unlike the revised IHR, the United States has had obligations under these WTO agreements since 1995 and thus already has systems in place that operate U.S. trade policy in conformity with the nation’s rights and duties under international trade law.
Trade in Goods: GATT, the SPS Agreement, and the Expanded NQS
GATT and the SPS Agreement apply to governmental measures that affect international trade in goods; and thus the scope of these agreements’ application is narrower than the revised IHR, which have rules applying to goods, conveyances, containers, and travelers. The impact of GATT and the SPS Agreement on the expanded NQS is, as a result, more limited because these trade agreements have no relevance for public health measures taken to address disease threats presented by people and transportation technologies. Further, as explored below, the scope of the SPS Agreement is narrower than GATT in terms of trade in goods.
General Principle and Scope
Both GATT and the SPS Agreement recognize each WTO member’s sovereign right to take measures necessary for the protection of human, animal, and plant life or health (GATT, Article XX[b]; SPS Agreement, Preamble and Article 2.1). Both agreements apply, however, disciplines to the exercise of this sovereign right; and the three main categories into which these disciplines fall are explored below.
A particular threat to health may fall within the scope of both GATT and the SPS Agreement, but the SPS Agreement is the controlling treaty for “sanitary and phytosanitary measures” (SPS measures). For purposes of protecting human health, which is the objective of the expanded NQS, SPS measures fall within the SPS Agreement if a WTO member applies them to protect human life or health within its territory from risks arising from (1) additives, contaminants, toxins, or disease-causing organisms in foods, beverages, or feedstuffs; or (2) diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests (Annex A, ¶1).
Health risks from international trade in goods not encompassed by the definition of SPS measures (e.g., trade in asbestos-containing products) fall within the scope of GATT.
The expanded NQS will most likely apply health-protecting measures against goods that fall within the SPS Agreement’s definition of SPS measures. The Consultant perceives that the federal government will involve the expanded NQS as part of the effort to prevent and control risks to the safety of the country’s food supply and risks presented by zoonotic and vector-borne diseases. SPS measures adopted by the United States and implemented by the expanded NQS will, therefore, have to comply with the obligations the United States has accepted under the SPS Agreement. This memorandum will, thus, focus on the SPS Agreement rather than GATT as the more pertinent treaty. The memorandum will address the most important issues for the expanded NQS raised by the SPS Agreement, but Annex 2 hereto provides a provision-by-provision analysis of the SPS Agreement’s implications for the expanded NQS.
Science-Based Disciplines in the SPS Agreement
The SPS measures of WTO members that affect international trade must be based on scientific principles and a risk assessment and must not be maintained without sufficient scientific evidence (Articles 2.2 and 5.10). In situations in which relevant scientific evidence and information is insufficient, WTO members may implement SPS measures but must seek to obtain additional information to develop a more objective risk assessment and review the measure within a reasonable period of time to determine whether its application is still warranted (Article 5.7).
The science-based disciplines are serious obligations of which the expanded NQS should be aware, particularly because the expanded system may more frequently implement SPS measures that affect international trade in goods. The SPS Agreement’s scientific disciplines do not, however, pose significant problems for the operations of the expanded NQS because federal public health authorities typically strive to ground their policies in scientific principles, risk assessment, and evidence because such grounding proves the most effective way to protect human health.
The WTO dispute settlement process has, to date, resolved four disputes under the SPS Agreement, only one of which (EC–Hormones) involved human health. Through these disputes, the WTO dispute settlement body has interpreted the science-based disciplines in the SPS Agreement. The Consultant has not included discussion of this case law in this memorandum because such discussion would involve lengthy technical analysis, but the Consultant would be willing to provide the committee with the state of the case law upon its request.
Harmonization Disciplines
The SPS Agreement’s second category of disciplines on the sovereign right to restrict trade in goods to protect human health involves obligations on WTO members to harmonize their national SPS measures. The SPS Agreement requires WTO members to base their national SPS measures on applicable international standards, guidelines, and recommendations (Article 3.1). The SPS Agreement recognizes the Codex Alimentarius Commission as the source for international guidance on food safety, the International Office of Epizootics for animal health and zoonoses, and the Secretariat of the International Plant Protection Convention for plant health (Annex A, ¶3). Conforming national SPS measures to international standards, guidelines, and recommendations means that the SPS measures are presumed to comply with both the SPS Agreement and GATT (Article 3.2).
If a WTO member wants to implement a SPS measure that achieves a higher level of protection than a relevant international standard, guideline, or recommendation, then it may—provided that the WTO member has a scientific justification for the measure and complies with the rest of the SPS Agreement in applying the measure (Article 3.3). This provision balances the sovereign right to the WTO member to protect the health of its people with the need to justify scientifically the higher level of protection sought. The revised IHR contain the same dynamic with respect to a WHO member’s ability to apply a health measure that achieves the same or greater level of health protection than WHO recommendations (IHR, Article 43), as discussed earlier. The appearance of this dynamic in both the revised IHR and SPS Agreement suggests that the expanded NQS should be aware of the need to operate with it in mind.
Trade-Related Disciplines
The last set of major obligations applied by the SPS Agreement to the SPS measures of WTO members is the trade-related disciplines. These disciplines require that WTO members apply their national SPS measures in ways that (1) are not more trade restrictive than required to achieve the level of health protection desired (Article 5.6); and (2) do not arbitrarily or unjustifiably discriminate between the goods of WTO members or constitute a disguised restriction on international trade (Articles 2.3 and 5.5). The SPS Agreement’s trade-related disciplines echo the purpose and objective of the revised IHR to avoid unnecessary interference with international traffic and trade (IHR, Article 2). The expanded NQS will have to bear such trade-related considerations in mind in implementing health
measures that affect international trade in goods under both the revised IHR and the SPS Agreement.
The SPS Agreement also contains a number of procedural obligations designed to reduce the burden the application of SPS measures imposes on international trade. The SPS Agreement requires transparency of information concerning SPS measures (Article 7 and Annex B) and obligates WTO members to apply their control, inspection, and approval procedures in a transparent, efficient, equitable, and nondiscriminatory manner (Article 8 and Annex C). Again, these disciplines do not present an expanded NQS with significant problems; but the expanded system will have to operate according to these obligations in applying SPS measures.
Application of National SPS Measures in the Territory of Other WTO Members
The SPS Agreement contemplates at least two situations in which one WTO member may apply its SPS measures in the territory of other WTO members. First, the SPS Agreement requires a WTO member to accept the SPS measures of another WTO member as equivalent to its own (and thus to avoid the application of multiple SPS measures, all of which achieve the same level of health protection), if the exporting WTO member can objectively demonstrate to the importing WTO member that its measures achieve the importing member’s desired level of health protection (Article 4.1). To achieve recognition of SPS measure equivalence, the exporting WTO member has to allow the importing WTO member into its territory for inspection, testing, and other relevant procedures (Article 4.1). The second situation concerns the application of a SPS measure that requires control at the level of the production of the good. In such a situation, the WTO member in which the relevant production takes place has to “provide the necessary assistance to facilitate such control and the work of the controlling authorities” (Annex C, ¶2).
Given the possibility that the expanded NQS may post personnel in foreign countries, these provisions in the SPS Agreement may help facilitate cooperation between the U.S. personnel and the host government with respect to SPS measures on goods exported to the United States.
Summary on the SPS Agreement and the Expanded NQS
The SPS Agreement’s importance to the expanded NQS will depend on the extent to which the expanded system applies SPS measures in ways that affect international trade in goods. The comprehensive nature of the strategy to expand the NQS suggests that its mandate will involve addressing health threats that may arise through the importation of goods into the
United States. Thus, the expanded NQS will have to operate within the disciplines created by the SPS Agreement. These disciplines do not, however, appear to present serious obstacles for the effective and efficient working of an expanded NQS.
Trade in Services: GATS and the Expanded NQS
In addition to liberalizing international trade in goods, international trade law also involves the movement of people through agreements that address international trade in services. At the WTO level, GATS provides an international legal framework designed to help liberalize international trade in services. GATS covers the temporary movement of natural persons supplying a service in the territory of another WTO member (Article 2.2[d] and Annex on Movement of Natural Persons Supplying Services under the Agreement). WTO members can make commitments to allow more foreign service suppliers to provide services on a temporary basis in their territories (Articles XVI and XVII). GATS commitments on the movement of natural persons do not apply to people seeking citizenship, residence, or employment on a permanent basis (Annex on Movement of Natural Persons Supplying Services under the Agreement, ¶2).
The United States could increase the number of foreigners coming to the United States to supply services temporarily under GATS if it made binding commitments to do so. Such binding commitments would not, however, limit or directly regulate the ability of the United States to apply its public health measures to foreign service suppliers entering the United States. GATS does not govern the application of such health measures, nor does any WTO agreement. Further, the disciplines of the revised IHR on health measures relating to entry to travelers do not preclude a state party from requiring medical examination, vaccination, or other prophylaxis as a condition for entry for any travelers seeking temporary or permanent residence (IHR, Article 31.1[b]).
In short, liberalization of trade in services through the temporary movement of natural persons into the United States under GATS would not weaken the expanded NQS’ authority to carry out its public health functions. The same principle and outcome appears in the provisions on cross-border trade in services in the North American Free Trade Agreement (NAFTA, Article 1201.3).
5. INTERNATIONAL HUMAN RIGHTS LAW
The revised IHR’s mandates that states parties implement their health measures “with full respect for the dignity, human rights, and fundamental freedoms of persons” (Article 3.1), “with respect for their dignity, human
rights and fundamental freedoms” (Article 32), and in a manner not more intrusive or invasive for persons than necessary to achieve the public health objective (Articles 23.2 and 43.1) put international human rights law on the agenda of the expansion of the NQS. This body of law would be on the agenda without the revised IHR’s reference to it because the United States is party to international human rights treaties that apply to public health measures imposed against individuals in the United States. The most important of these treaties for purposes of this memorandum is the International Covenant on Civil and Political Rights (ICCPR).
Restricting Civil and Political Rights for Public Health Purposes Under International Human Rights Law
In the area of civil and political rights, international human rights law recognizes public health as a legitimate reason for interfering with the enjoyment of certain civil and political rights. The ICCPR expressly recognizes public health as a justification for restriction specific rights (Articles 12.3, 18.3, 19.3, 21, and 22.2). The ICCPR also permits states parties to restrict other rights in accordance with grounds and procedures recognized by law (Articles 9 and 17), which includes restrictions on such rights undertaken to protect public health. Table F.1 contains the rights in the ICCPR most relevant to the kinds of public health actions the expanded NQS may have to take against individuals.
One civil and political right relevant to potential activities of the expanded NQS against which no restrictions or derogations are permitted is the right not be subject to torture or cruel, inhuman, or degrading treatment or punishment and not to be subject to medical or scientific experimentation with a person’s free consent (Article 7). These rights would be relevant in circumstances in which the expanded NQS might subject individuals to (1) medical examinations, vaccination, prophylaxis or other health measures that negligently or unnecessarily caused severe pain and suffering; (2) medical examination, detention, quarantine, or isolation in cruel, inhuman, or degrading conditions; and (3) the use of experimental vaccines or drugs without the individuals’ free, informed consent.
Disciplines on Public Health Restrictions on Civil and Political Rights
Although the ICCPR recognizes public health as a justification for restricting certain civil and political rights, international human rights law requires that the exercise of restrictions that are necessary to protect public health satisfy other disciplines to ensure that the rights are respected to the maximum extent possible. For derogations of rights under the ICCPR, international lawyers generally recognize the Siracusa Principles on the
TABLE F.1 Public Health-Related Civil and Political Rights in the ICCPR
Article |
Content of the Civil and Political Right |
Express/Implicit Recognition of Public Health |
Public Health Acts Affecting Right |
9.1 |
Everyone has the right to liberty and security of person. No one shall be subjected to arbitrary arrest or detention. No one shall be deprived of his liberty except on such grounds and in accordance with such procedures as are established by law. |
Implicit |
-Detention for medical examination -Quarantine -Isolation |
12 |
1. Everyone lawfully within the territory of a State shall, within that territory, have the right of liberty of movement and freedom to choose his residence. 2. Everyone shall be free to leave any country, including his own. |
Express (Article 12.3) |
-Detention for medical examination -Quarantine -Isolation |
17.1 |
No one shall be subjected to arbitrary or unlawful interference with his privacy, family, home or correspondence, nor to unlawful attacks on his honour and reputation. |
Implicit |
-Compulsory medical examination, vaccination, prophylaxis, or other invasive or intrusive health measure -Collection and dissemination of personal information |
18.1 |
Everyone shall have the right to freedom of thought, conscience, and religion. |
Express (Article 18.3) |
-Compulsory medical examination, vaccination, prophylaxis, or other invasive or intrusive health measure |
19.2 |
Everyone shall have the right to freedom of expression…. |
Express (Article 19.3) |
-Restrictions on publishing or disseminating information necessary to protect public health |
21 |
The right of peaceful assembly shall be recognized. |
Express (Article 21, second sentence) |
-Restricting public or gatherings in order to protect public health |
22.1 |
Everyone shall have the right to freedom of association with others, including the right to form and join trade unions for the protection of their interests. |
Express (Article 22.2) |
-Restricting public or gatherings in order to protect public health |
Limitation and Derogation of Provisions in the International Covenant on Civil and Political Rights (Siracusa Principles) as an authoritative statement of the disciplines states parties to the ICCPR must satisfy to restrict civil and political rights legitimately.
For a restriction on a civil and political right to be necessary within the meaning of the ICCPR, the restriction must (1) be based (where applicable) on one of the grounds justifying restrictions contained in the relevant article of the ICCPR; (2) respond to a pressing public or social need; (3) pursue a legitimate aim; (4) be proportionate to the legitimate aim; and (5) be no more restrictive than is required to achieve the purpose sought by restricting the right (Siracusa Principles, Article 10). In addition, the restrictive measure must be applied in a nondiscriminatory manner (ICCPR, Articles 2.1 and 26).
The revised IHR attempt to incorporate some of these disciplines, illustrating the importance of international human rights law for the expanded NQS. The revised IHR require, among other things, that health measures have a scientific basis and justification; not be applied to individuals without their consent unless in a situation of imminent public health danger; be not more intrusive or invasive than reasonably available alternatives that would achieve the same level of health protection; be applied in ways sensitive to sociocultural, gender, ethnic, and religious concerns; operate in a manner that protects personal information as confidential; and be applied in a nondiscriminatory manner.
Further, the revised IHR also echo the right of all persons deprived of their liberty to be treated with humanity and with respect for the inherent dignity of the human person (ICCPR, Article 10.1) in its provision requiring states parties to provide for the needs of people subject to health measures (IHR, Article 32[c]). Thus, international human rights law will be important in interpreting what provisions of the revised IHR mean and how states parties apply health measures to travelers.
International human rights law has, however, broader application than the revised IHR. The expanded NQS may have to implement public health measures restricting civil and political rights against individuals who are not travelers within the meaning of the revised IHR—natural persons undertaking an international voyage (IHR, Article 1.1). The expanded NQS may have to restrict the civil and political rights of persons traveling within the United States, meaning the revised IHR would not apply but the ICCPR would. In a situation involving people moving within the United States, the overlap is between the ICCPR and U.S. constitutional law, which makes preparing the expanded NQS for operating in a manner sensitive to civil and political rights an important task for the federal government.
6. INTERNATIONAL LEGAL CONSIDERATIONS CONCERNING “FORWARD DEPLOYMENT” OF THE EXPANDED NQS
The above analysis of the revised IHR, international trade law, and international human rights law assumes that the expanded NQS would be applying public health measures in U.S. territory. As noted earlier, the Consultant understands that the federal government may wish to include in the expansion of the NQS the placement of U.S. public health personnel and resources in the territories of foreign countries. This aspect of the strategy to expand the NQS raises different international considerations, which this part briefly explores.
The federal government generally, and the CDC specifically, have great experience with using public health experts and resources in international cooperation with other countries and international organizations. To the Consultant’s knowledge, such cooperative ventures traditionally have not involved, however, establishing a permanent presence in other countries for purposes of minimizing exogenous threats to public health in the United States. Such a permanent presence implicates some basic principles of international law worth noting in this memorandum.
Federal government plans to expand the NQS by establishing assets overseas would require the full cooperation and permission of the foreign governments because these governments have sovereignty over their territories that the United States cannot infringe under international law. The principle prohibiting interference in the domestic affairs of other states supports the principle of sovereignty in underscoring the necessity that “forward deployment” of the expanded NQS be agreed in advance between the federal government and the foreign government.
Such agreements may be informal or formal under international law. The nature of the activities that the expanded NQS might undertake in the foreign country (e.g., inspection goods, cargo, and travelers bound for the United States) touch, however, on aspects of sovereignty and the organization of a country’s domestic affairs that would make the expanded NQS’ activities politically sensitive for a foreign government. A foreign government might be nervous about what kinds of information flows between the part of the expanded NQS in its territory and the rest of the system back in the United States. In all likelihood, a foreign government agreeing to host assets and personnel from the expanded NQS will require that the scope of the expanded NQS’ activities in its territory be carefully delineated in a formal, written agreement.
Another reason why a foreign government may insist on clearly defining the nature of the expanded NQS’ activities in its territory relates to that government’s own responsibilities under international law. A foreign government will need to avoid situations in which inspections and control
measures desired by the expanded NQS in its territory do not violate the government’s obligations under the revised IHR, international trade law, or international human rights law. A foreign government cannot “outsource” its international legal obligations to the United States through the assets and personnel of the expanded NQS in its territory.
Other reasons pointing to the need for formal, written agreements are more practical and involve establishing the procedures through which the expanded NQS would interact with the public health authorities of the host country. Would U.S. public health personnel stationed overseas have authority to administer medical examinations, vaccination, or prophylaxis to travelers bound for the United States, or would those “hands-on” functions be managed by the host government’s public health personnel? Would U.S. public health personnel incur personal liability under foreign law for engaging in expanded NQS activities in the host country? Would the United States government incur liability to foreign nationals or the foreign government for the negligence or problems caused by U.S. public health personnel stationed overseas as part of the expanded NQS.
The Consultant raises these issues and questions not to imply that a strategy of “forward deployment” would be impossible or ill-advised from an international legal perspective. The federal government engages in similar arrangements with foreign governments in connection with (1) U.S. customs officials stationed in Canada screening travelers destined for the United States at Canadian airports; (2) U.S. inspections of foreign production facilities for purposes of applying national sanitary or phytosanitary measures; and (3) homeland security efforts seeking to increase the security of U.S. ports by inspecting containers and vessels at foreign ports of departure rather than just at the U.S. ports of entry. Whether these examples could serve as models or precedents for “forward deployment” of the expanded NQS would have to be studied more comprehensively.
ANNEX 1
TABLE F.2 Summary Table of Important Positive and Negative Obligations the United States Has Under International Law Relevant to the Expansion of the National Quarantine System
Positive Obligationsa |
Negative Obligationsb |
Measures Applied Against Individuals |
|
|
|
Positive Obligationsa |
Negative Obligationsb |
|
|
Measures Applied Against Goods Science-Based Disciplines |
|
|
|
|
Harmonization Disciplines |
|
|
|
Trade-Related Disciplines |
|
|
|
Positive Obligationsa |
Negative Obligationsb |
|
|
Measures Applied at Points of Entry and Against Means of Transportation and Trade |
|
|
|
|
|
Positive Obligationsa |
Negative Obligationsb |
|
|
Measures Related to Administration, Surveillance, and Response |
|
|
|
|
Positive Obligationsa |
Negative Obligationsb |
|
|
NOTE: Areas of international law covered: Revised International Health Regulations (IHR 2005), the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) of the World Trade Organization, and the International Covenant on Civil and Political Rights (ICCPR). aPositive obligations = duties under international law that require affirmative action from the United States. bNegative obligations = duties under international law that require the United States not to take certain actions. |
ANNEX 2
TABLE F.3 Analysis of the Revised International Health Regulations: Implications for Plans to Expand the National Quarantine System
Revised IHR |
Implications for Plans to Expand the National Quarantine System (NQS) |
PART I—DEFINITIONS, PURPOSE AND SCOPE, PRINCIPLES, AND RESPONSIBLE AUTHORITIES |
|
Article 1 Definitions |
|
“Disease” means an illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans. |
The definition of “disease” in the revised IHR is important to the expanded NQS because this definition helps establish the scope of the revised IHR and the scope of its obligations. The revised IHR define “disease” to include chemical and radiological sources as well as biological sources. Thus, the revised IHR’s obligations on surveillance and response would go beyond communicable diseases. At present, the federal government appears to be designing the expanded NQS for communicable disease threats only. |
Article 2 Purpose and scope |
|
The purpose and scope of these Regulations are to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade. |
The purpose and scope of the revised IHR should not pose problems for the plans for the expanded NQS because the objectives of preventing, protecting, and controlling public health risks and providing a public health response to the spread of disease are consistent with the goals of the expanded NQS. Similarly, the United States has an interest in expanding the NQS in ways that do not unnecessarily interfere with international trade and travel. |
Article 3 Principles |
|
|
For the expanded NQS, Article 3.1 is important because it mandates that WHO member state implementation of the revised IHR shall occur with full respect for human rights and fundamental freedoms. |
Revised IHR |
Implications for Plans to Expand the National Quarantine System (NQS) |
|
The provision requires the expanded NQS to implement measures taken against people to comply with international human rights disciplines on the application of public health measures to individuals. See discussion in Memorandum on the disciplines found in international human rights law. |
Article 3.5 is important because it recognizes the right of the United States to legislate, and implement such legislation, to protect public health through its expanded NQS. |
|
Article 4 Responsible authorities |
|
|
This provision of the revised IHR presents an organizational and administration challenge for the expanded NQS. First, the United States has to designate a single National IHR Focal Point that can manage the functions indicated in Article 3.2 (perhaps the CDC in Atlanta). The CDC has to network all the pieces and components of the expanded NQS together to make sure that the National IHR Focal Point can fulfill its functions under the revised IHR. Second, Article 4.1 requires states parties to designate all authorities within their jurisdictions that will implement health measures under the revised IHR. Such authorities would include the components of the expanded NQS. |
|
|
PART II—INFORMATION AND PUBLIC HEALTH RESPONSE |
|
Article 5 Surveillance |
|
|
Article 5.1 is important for the expanded NQS because it requires the development, strengthening, and maintenance of surveillance capabilities in accordance with Annex 1 of the revised IHR as part of the revised IHR’s obligations on “core capacity requirements” for surveillance and response. The plan to expand and strengthen the |
Revised IHR |
Implications for Plans to Expand the National Quarantine System (NQS) |
|
NQS should constitute U.S. actions to develop and improve surveillance capacities as required by Article 5.1. The federal government would have to make sure, however, that the capabilities being included in the expanded NQS, combined with other federal and state public health assets, meet the core capacity requirement for surveillance mandated by Article 5.1 and Annex 1. For example, Annex 1 requires, at the local community level, the capacities “to detect events involving disease or death above expected levels for the particular time and place in all areas within the territory of the State Party” (Annex 1, Part A, ¶4[a]). The expanded NQS would only constitute part of such national surveillance capacities. |
Article 6 Notification |
|
|
The obligations in Articles 6.1 and 6.2 require close coordination and good communications between the parts of the expanded NQS and the U.S. National IHR Focal Point in order to notify WHO of events |
|
that may constitute a public health emergency of international concern within the time limits specified in the revised IHR. Further, Article 6.1 requires each part of the expanded NQS to be able to utilize the decision instrument contained in Annex 2 of the revised IHR. Articles 6.1 and 6.2 require states parties to report other types of information to WHO, including all health measures implemented in response to events that may constitute a public health emergency of international concern and other forms of public health information available to it (as indicated in Article 6.2); and the expanded NQS would need to be able to fulfill these requirements as well. |
Article 7 Information-sharing during unexpected or unusual public health events |
|
If a State Party has evidence of an unexpected or unusual public health event within its territory, irrespective of origin or source, which may constitute a public health emergency of international concern, it shall provide to WHO all relevant public health information. In such a case, the provisions of Article 6 shall apply in full. |
Article 7 is what remains of a provision that, in previous negotiating texts, referred specifically to suspected intentional releases of biological, chemical, or radionuclear agents. In the revised IHR, it is difficult to see how Article 7’s requirements go beyond what states parties are already bound to do under Article 6. From the U.S. perspective, Article 7 is perhaps further evidence that the revised IHR apply to intentional releases of biological, chemical, or radionuclear agents. The expanded NQS might be involved in having to address such a suspected intentional release and thus be affected by Article 7. |
Revised IHR |
Implications for Plans to Expand the National Quarantine System (NQS) |
Article 8 Consultation |
|
In the case of events occurring within its territory not requiring notification as provided in Article 6, in particular those events for which there is insufficient information available to complete the decision instrument, a State Party may nevertheless keep WHO advised thereof through the National IHR Focal Point and consult with WHO on appropriate health measures. Such communications shall be treated in accordance with paragraphs 2 to 4 of Article 11. The State Party in whose territory the event has occurred may request WHO assistance to assess any epidemiological evidence obtained by that State Party. |
Article 8 outlines discretionary actions that states parties may take with respect to events not requiring notification to WHO under Article 6; and, thus, Article 8 would not impose any obligations or limits on the expanded NQS. |
Article 9 Other reports |
|
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Article 9.1 empowers WHO to collect and use sources of information from nongovernmental sources of information and, thus, would not impose any obligations or limits on the expanded NQS. This authority for WHO could affect the expanded NQS if WHO collects nongovernmental information concerning disease events in the United States, requiring input from the expanded NQS if WHO seeks to consult with the United States concerning verification of such reports. |
The obligation in Article 7.2 would affect the expanded NQS because the NQS may receive information about public health risks outside the United States that may cause international disease spread, particularly if the expanded NQS has established offices or capabilities in foreign countries. This obligation could create friction with any host government that does not want to notify WHO |
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pursuant to Article 6 of the revised IHR. The United States would have to be careful in negotiating any arrangement with a foreign government not to bind itself to rules that prevent fulfillment of the obligation in Article 9.2. |
Article 10 Verification |
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The Article 10 verification process affects the expanded NQS because the nature of information required to be provided to WHO under Article 10.2 would, in all likelihood, involve various components of the expanded NQS. The expanded NQS must have, therefore, the capacity to respond to such verification requests from WHO. In the unlikely event that the United States would request assistance from WHO to manage a disease threat pursuant to Article 10.3, the collaboration with WHO in the United States would have to draw on various assets of the expanded NQS. |
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Article 11 Provision of information by WHO |
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Article 11 concerns responsibilities of WHO for the provision of information to states parties to the revised IHR. The expanded NQS will have to develop communication mechanisms to distribute information provided by WHO that is relevant for addressing public health problems and events in the United States. |
provisions, shall not make this information generally available to other States Parties, until such time as:
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Article 12 Determination of a public health emergency of international concern |
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Article 12 concerns the power in the revised IHR for the WHO Director-General to declare whether an event constitutes a public health emergency of international concern. The only obligation on the United States under Article 12 is to consult with the Director-General concerning whether an event constitutes a public health emergency of international concern. Elements of the expanded NQS could be called upon by the CDC to participate in such a consultation process and/or in the Article 49 procedure mentioned in Articles 12.2 and 12.3. |
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Article 13 Public health response |
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Article 13.1 is important for the expanded NQS because it requires the development, strengthening, and maintenance of response capabilities in accordance with Annex 1 of the revised IHR as part of the revised IHR’s obligations on “core capacity requirements” for surveillance and response. The plan to expand and strengthen the NQS should constitute U.S. actions to develop and improve response capacities as required by Article 13.1. The federal government would have to make sure, however, that the capabilities being included in the expanded NQS, combined with other federal and state public health assets, meet the core capacity requirement for surveillance mandated by Article 13.1 and Annex 1. For example, Annex 1 requires, at the national level, seven response capacities provided on a 24-hour basis (Annex 1, Part A, ¶4–6). The expanded NQS would only constitute part of such national response capacities. WHO could |
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also call on the resources and expertise of the expanded NQS under Article 13.4 to provide support for WHO-coordinated response activities, perhaps as WHO has historically called on the CDC for support in international response activities. |
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Article 14 Cooperation of WHO with intergovernmental organizations and international bodies |
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This provision has little direct relevance for the expanded NQS because it addresses WHO cooperation with other intergovernmental organizations and international bodies. |
PART III—RECOMMENDATIONS |
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Article 15 Temporary recommendations |
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Article 15 empowers the WHO Director-General to issue temporary recommendations to states parties to assist them in responding to public health emergencies of international concern. Such recommendations would not be binding on states parties to the revised IHR but represent recommended guidance from WHO. If the United States agreed to implement such temporary recommendations, |
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then the expanded NQS might be called on to carry out the recommendations. Article 18 (below) contains a list of the types of recommendations WHO may issue to states parties with respect to persons (Article 18.1) and conveyances, containers, goods, cargo, baggage, and postal parcels (Article 18.2). To carry out temporary recommendations, the expanded NQS would need to have sufficient national legal authority to implement such recommendations. |
Article 16 Standing recommendations |
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WHO may make standing recommendations of appropriate health measures in accordance with Article 53 for routine or periodic application. Such measures may be applied by States Parties regarding persons, baggage, cargo, containers, conveyances, goods and/or postal parcels for specific, ongoing public health risks in order to prevent or reduce the international spread of disease and avoid unnecessary |
Article 16 empowers the WHO Director-General to issue standing recommendations concerning health measures to be applied routinely or periodicly. Such recommendations would not be binding on states parties to the revised IHR but represent recommended guidance from WHO. If the United States agreed to implement such standing recommendations, then the expanded NQS might be called on to carry out the recommendations. To carry out standing recommendations, |
interference with international traffic. WHO may, in accordance with Article 53, modify or terminate such recommendations, as appropriate. |
the expanded NQS would need to have sufficient national legal authority to implement such recommendations. |
Article 17 Criteria for recommendations |
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When issuing, modifying or terminating temporary or standing recommendations, the Director-General shall consider:
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The revised IHR direct this provision at the WHO Director-General, and it does not create obligations for or limitations on the expanded NQS. |
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Article 18 Recommendations with respect to persons, conveyances, containers, goods, cargo, baggage and postal parcels |
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Article 18.1 lists possible recommendations that WHO could issue with respect to persons, and Article 18.2 lists possible recommendations concerning conveyances, containers, goods, cargo, baggage, and postal parcels. As noted above, the United States would not be obligated as a matter of international law to implement any WHO recommendation issued under the revised IHR. The United States would have to have domestic legal authority to implement any recommendations it decided to follow. These recommendations could involve restrictions on entry into the United States or exit from the United States. In addition, implementing recommendations with respect to persons would have to comply with the provisions of the revised IHR that address protecting the rights and dignity of individuals and applicable international human rights law. Implementing recommendations with respect to goods would have to comply with relevant rules of international trade law. |
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PART IV—POINTS OF ENTRY |
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Article 19 General obligations |
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Each State Party shall, in addition to the other obligations provided for under these Regulations:
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Article 19(a) imposes obligations on the expanded NQS. First, the provision would require the United States to develop the core capacities indicated in Annex 1, Part B of the revised IHR for designated ports of entry. Given that the expansion of the NQS focuses on points of entry into the United States, such as seaports and airports, the obligations in Article 19(a) and Annex 1, Part B would be directly relevant to the expanded NQS. The core capacity requirements for ports of entry resonate with the federal government’s desire to make the expanded NQS a resource that does more than engage in narrow quarantine activities. Articles 19(b) and (c) also impose duties on the expanded NQS to identify the proper authorities for each designated point of entry and to furnish to WHO in connection with a specific public health threat information concerning sources of infection or contamination at points of entry. |
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Article 20 Airports and ports |
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Article 20.1 requires states parties to designate ports and airports that will develop the core capacities found in Annex 1, Part B. The United States, thus, has to identify which ports and airports will have the core capacities required by the revised IHR. |
Article 20.2 imposes obligations on those parts of the expanded NQS that concern seaports because it requires states parties to ensure that specific ship sanitation documents are issued in accordance with Article 39 and Annex 3 of the revised IHR. Article 20.3 would require the United States to provide WHO with a list of seaports authorized to issue these ship sanitation documents. |
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Under Article 20.4, the United States could request the WHO to certify that airports and seaports in its territory have the required core capacities and, in the case of seaports, can issue the ship sanitation documents in accordance with the revised IHR. Such a certification process would be entirely voluntary on the part of the United States, and thus this provision creates no obligations for the expanded NQS. |
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Article 21 Ground crossings |
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Article 21 refers to a discretionary procedure under which the United States could designate ground crossings that shall have the core capacities identified for points of entry in Annex 1, Part B. Thus, the United States could designate any ground-crossing component of the expanded NQS as a point of entry having all the core capacities recognized by the revised IHR as important. Article 21 also encourages the United States to develop agreements with Mexico and Canada concerning the prevention and control of disease at ground crossings. |
Article 22 Role of competent authorities |
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Articles 22.1 and 22.3 impose numerous obligations on the various parts of the expanded NQS. The revised IHR define “competent authorities” as “the authority responsible for the implementation and application of health measures under these Regulations” (Article 1.1). |
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Federal quarantine stations in the expanded NQS would fall into the definition of “competent authorities” and thus be directly subject to the mandates of Article 22.1 and 22.3 and any other obligation the revised IHR impose on competent authorities. |
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PART V—PUBLIC HEALTH MEASURES |
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Chapter I—General provisions |
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Article 23 Health measures on arrival and departure |
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Articles 23.1 and 23.2 allow states parties to apply certain health measures to travelers, conveyances, containers, cargo, goods, postal parcels, and human remains. These provisions contain no binding duties; but Article 23.2 indicates that states parties, in applying additional health measures to suspect or affected travelers, should use the least intrusive and invasive medical examination that would achieve the public health objective. |
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Articles 23.3, 23.4, and 23.5 contain mandatory obligations that affect how the expanded NQS would operate with respect to travelers. Article 23.3 requires that states parties obtain the express consent for an individual before carrying out any health measure on the individual, except in situations provided for in Article 31.2 (see below), and carry out such measures in accordance with the states parties’ domestic law and international obligations. Article 23.4 requires that states parties inform travelers to be vaccinated or offered prophylaxis of any risk associated with such measures in accordance with the states parties’ domestic laws and international obligations. Article 23.5 requires states parties to perform any health measure that involves the risk of disease transmission to be performed only on a traveler in accordance with established national or international safety guidelines and standards in order to minimize the risk. |
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Chapter II—Special provisions for conveyances and conveyance operators |
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Article 24 Conveyance operators |
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Article 24.1 requires the United States to ensure that all conveyance operators comply with, and inform travelers of, health measures recommended by WHO and adopted by the United States. In addition, Article 24.1 requires the United States to keep all conveyances for which it is responsible permanently free of infection or contamination, including vectors and reservoirs. The expanded NQS may well have to be involved in the fulfillment of these obligations. |
Article 24.2 refers to specific provisions pertaining to conveyances and conveyance operates found in Annexes 4 and 5 of the revised IHR. Section A of Annex 4 contains obligations on conveyance operators (e.g., to facilitate inspections), and the United States would have to use domestic law to impose these obligations on conveyance operators as part of the expanded NQS. Section B of Annex 4 imposes obligations on states parties that apply control measures to conveyances, containers, cargo, goods, and baggage: (1) such control measures must be carried out so as to avoid as far as possible injury or discomfort to people or damage to property; and (2) states parties |
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must put in writing the control measures applied and the reasons therefore. These duties would affect the operation of the expanded NQS. |
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Annex 5 contains specific measures for the control of vector-borne diseases that states parties may apply or use, but Annex 5 only has three obligations on states parties: (1) requiring states parties to mandate that conveyance operators report information on the presence of vectors on board and the measures used to eradicate them; (2) requiring states parties to have programs to control disease vectors of public health concern around the boundaries of points of entry and exit in their territories; and (3) requiring competent authorities that have undertaken control measures to inform the competent authorities of the conveyance’s next port or airport of call that follow-up control measures are required. Each of these obligations would affect the operation of the expanded NQS. |
Article 25 Ships and aircraft in transit |
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Subject to Articles 27 and 43 or unless authorized by applicable international agreements, no health measure shall be applied by a State Party to:
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Article 25 prohibits states parties from applying health measures to ships and aircraft in transit and requires states parties to allow ships and aircraft in transit to take on fuel, water, food, and supplies. The provision provides three exceptions to the prohibition: (1) if the ship or aircraft is an affected conveyance (Article 27); (2) if the state party in question believes that additional health measures are scientifically justified (Article 43); and (3) if an applicable international agreement permits the state party to apply health measures. This provision would be of direct concern to the expanded NQS. |
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Article 26 Civilian lorries, trains and coaches in transit |
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Subject to Article 27 and 43 or unless authorized by applicable international agreements, no health measure shall be applied to a civilian lorry, train or coach not coming from an affected area which passes through a territory without embarking, disembarking, loading or discharging. |
This prohibition might affect the expanded NQS, but most civilian lorries, trains or coaches entering the United States from Canada or Mexico are unlikely to pass through the United States without embarking, disembarking, loading, or discharging. |
Article 27 Affected conveyances |
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Article 27.1 requires states parties to consider a conveyance affected if evidence or indications of a public health risk are found on board and then provides options for how states parties should deal with the affected conveyance. This provision would not create difficulties for the expanded NQS because addressing evidence or indications of public health risks on board conveyances would be within its mandate. Elements of the expanded NQS would have to have capabilities to undertake dealing with the affected conveyance. |
Article 27.2 addresses the procedure if the competent authorities at the point of entry are not equipped to apply adequate control measures to an affected conveyance, and this provision would only be relevant if a component of the expanded NQS did not have the appropriate capabilities. Article 27.2 requires the competent authority |
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The competent authority may implement additional health measures, including isolation of the conveyances, as necessary, to prevent the spread of disease. Such additional measures should be reported to the National IHR Focal Point.
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at the point of entry to notify the competent authority at the next known point of entry about the affected conveyance, to note evidence of infection and control measures needed on a ship’s sanitation control certificate, and to allow any affected conveyance to take on fuel, water, and supplies. |
Article 28 Ships or aircraft at points of entry |
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Articles 28.1 and 28.2 prevent a state party from refusing for public health reasons to (1) allow a ship or an aircraft from calling any point of entry; and (2) grant a ship or aircraft free pratique. (Article 1.1 defines free pratique as “permission for a ship to enter a port, embark or disembark, discharge or load cargo or stores; permission for an aircraft, after landing, to embark or disembark, discharge or load stores; and permission for a train or road vehicle, upon arrival, to embark or disembark, discharge or load cargo or stores.”) These prohibitions have two exceptions: (1) if the state party prevents entry or free pratique using additional health measures justified by Article 43; and (2) if prevention of entry or free pratique is justified by another applicable international agreement. The elements of the expanded NQS would be in the position of having to make the kinds of decisions referred to in Articles 28.1 and 28.2. |
Articles 28.4, 28.5(a), and 28.6 require officers and pilots of ships and aircraft to communicate various types of information to the port or airport of entry concerning defined situations (e.g., indications of illness on board). The parts of the expanded NQS would have to have the capacity to receive and act on such information provided by officers and pilots of ships and aircraft. These provisions would also allow the expanded NQS to require such communications from officers and pilots of ships and aircraft. |
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Article 29 Civilian lorries, trains and coaches at points of entry |
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WHO, in consultation with States Parties, shall develop guiding principles for applying health measures to civilian lorries, trains and coaches at points of entry and passing through ground crossings. |
This provision requires WHO to develop guidelines on health measures applied to conveyances at ground crossings. Such guidance from WHO would not be binding on the expanded NQS. |
Chapter III—Special provisions for travelers |
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Article 30 Travellers under public health observation |
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Subject to Article 43 or as authorized in applicable international agreements, a suspect traveller who on arrival is placed under public health observation may continue an international voyage, if the traveller does not pose an imminent public health risk and the State Party informs the competent authority of the |
Article 30 sets down the procedure the expanded NQS would use in connection with a suspect traveler placed under public health observation. The expanded NQS may allow such traveler to continue an international voyage, provided that the traveler does not pose an imminent public health risk. If the United States allows such a suspect |
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point of entry at destination, if known, of the traveller’s expected arrival. On arrival, the traveller shall report to that authority. |
traveler to continue on an international voyage, then it must inform the competent authority of the point of next entry or destination. Similarly, the United States could receive information from other IHR states parties that a suspect traveler’s next port of entry or destination is the United States. |
Article 31 Health measures relating to entry of travellers |
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Article 31 contains rules on the implementation of health measures against travelers and, thus, are of importance to the expanded NQS. The basic rule prohibits requiring that travelers undergo invasive medical examination, vaccination, or other prophylaxis as a condition of entry. The expanded NQS could, thus, only implement invasive medical examination, vaccination, or other prophylaxis against a traveler under four exceptions: (1) when necessary to determine whether a public health risk exists; (2) as a condition of entry for any travelers seeking temporary or permanent residence; (3) as an additional health measure justified under Article 43 and subject to Article 43’s disciplines; (4) as a condition of entry under Annexes 6 (Vaccination, Prophylaxis and Related Certificates) and 7 (Requirements Concerning Vaccination or Prophylaxis for Specific Diseases [concerning yellow fever]); and (5) examinations, vaccinations, or prophylaxis carried out under Article 23. |
Concerning a traveler that refuses to give his or her consent to examination, vaccination, or prophylaxis as required by Article 23, a state party may either (1) refuse entry to that traveler; or (2) if the state party has evidence that there is evidence of an imminent public health risk, compel the traveler to undergo measures necessary to control such risk (examination, vaccination, prophylaxis, isolation, |
accordance with its national law and to the extent necessary to control such a risk, compel the traveller to undergo or advise the traveller, pursuant to paragraph 3 of Article 23, to undergo:
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quarantine, public health observation) (Article 31.2). Use of compulsory measures would also be subject to the disciplines found in Articles 32 (Treatment of Travellers), 42 (Implementation of Health Measures), and 45 (Treatment of Personal Data) of the revised IHR. |
Article 32 Treatment of travellers |
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In implementing health measures under these Regulations, States Parties shall treat travellers with respect for their dignity, human rights and fundamental freedoms and minimize any discomfort or distress associated with such measures, including by:
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This provision mandates that states parties treat travelers with respect of their dignity, human rights, and fundamental freedoms and minimize any discomfort or distress associated with the implementation of health measures. This mandate specifically mentions (but is not necessarily limited to) treating all travelers with courtesy and respect, taking into consideration gender, sociocultural, ethnic, or religious concerns of travelers; and providing for various necessities (food, water, shelter, medical treatment) for travelers who are quarantined, isolated, or subject to medical examination or other public health measures. This provision would have direct implications for the expanded NQS’ treatment of travelers. |
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Chapter IV—Special provisions for goods, containers and container loading areas |
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Article 33 Goods in transit |
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Subject to Article 43 or unless authorized by applicable international agreements, goods, other than live animals, in transit without transshipment shall not be subject to health measures under these Regulations or detained for public health purposes. |
The general rule in Article 33 is that goods (excluding live animals) in transit without transshipment (i.e., the goods are on their way to another destination without crossing through the territory of the state party in question) shall not be subject to health measures or detained for public health purposes. This rule has two exceptions: (1) a health measure issued pursuant to Article 43; or (2) a measure authorized by an applicable international agreement (e.g., an international trade agreement). This duty requires the expanded NQS to identify goods in transit without transshipment from goods being imported into the United States for purposes of applying public health measures. |
Article 34 Container and container loading areas |
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Article 34 contains various rules that impose on states parties obligations to ensure that containers and container loading areas are not, and do not become, sources of infection or contamination. These rules require the expanded NQS to have the ability to inspect containers and container loading areas within the United States and to monitor private-actor compliance with domestic legal obligations to keep containers and container loading areas free from sources of infection and contamination. |
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PART VI—HEALTH DOCUMENTS |
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Article 35 General rule |
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No health documents, other than those provided for under these Regulations or in recommendations issued by WHO, shall be required in international traffic, provided however that this Article shall not apply to travellers seeking temporary or permanent residence, nor shall it apply to document requirements concerning the public health status of goods or cargo in international trade pursuant to applicable international agreements. The competent authority may request travellers to complete contact information forms and questionnaires on the health of travellers, provided that they meet the requirements set out in Article 23. |
This provision regulates what kind of health documents a state party can require of travelers and traders and thus is directly relevant to the tasks the expanded NQS will be undertaking. Article 35 establishes a general rule—a state party can require no health documents concerning international traffic except documents provided for in the revised IHR (e.g., yellow fever vaccination certificate [Annex 7]) or recommended by WHO. The scope of this general rule does not include document requirements for persons seeking temporary or permanent residence or concerning the public health status of goods or cargo permitted under other applicable international agreements (e.g., international trade agreements). |
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Article 35 does not contain any express exceptions. Further, Article 43.1(b) on additional health measures does not mention Article 35 as one of the prohibitions that an additional health measure could |
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legitimately ignore. It is not clear whether a state party may require additional health documents besides those recommended by WHO under Article 43.1(a), which allows additional health measures that achieve the same or greater level of health protection than WHO recommendations. |
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These rules on health documents directly affect the operations of the expanded NQS. |
Article 36 Certificates of vaccination or other prophylaxis |
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The provision regulates (1) vaccines and prophylaxis administered under the revised IHR; and (2) certificates of vaccination or other prophylaxis issued under the Regulations. Vaccines or other prophylaxis administered to travelers must be of suitable quality and those vaccines or prophylaxis designated by WHO shall be subject to its approval (Annex 6, ¶1). If WHO requests, a state party must provide evidence of the suitability of the vaccines and prophylaxis administered within its territory under the IHR (Annex 6, ¶1). Annex 6 also contains rules that determine the form of certificates to be issued to travelers and how forms are completed. Annex 6, ¶2 provides that “[n]o departure shall be made from the model of the certificate specified in this Annex.” The administration of vaccination or other prophylaxis by the expanded NQS to travelers implicates the United States’ duty to comply with these rules. |
Article 37 Maritime Declaration of Health |
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The State Party shall inform shipping operators or their agents of these requirements. |
This provision would allow (but does not mandate) the United States to require that the masters of ships arriving in U.S. territory ascertain the health conditions on board the vessel and deliver (at arrival or earlier) a Maritime Declaration of Health in the form provided in Annex 8. If the United States adopted such a requirement, it would be obliged to notify shipping interests about its rules on Maritime Declarations of Health. A U.S. requirement for delivery of Maritime Declarations of Health would affect the expanded NQS because this system would be receiving and, if necessary, acting upon the Maritime Declarations of Health. |
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Article 38 Health Part of the Aircraft General Declaration |
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The State Party shall inform aircraft operators or their agents of these requirements. |
This provision would allow (but does not mandate) the United States to require that pilots of aircraft arriving in U.S. territory complete and deliver the Health Part of the Aircraft General Declaration in the form provided in Annex 9. If the United States adopted such a requirement, it would be obliged to notify aircraft operators about its rules on the Health Part of the General Aircraft Declaration. A U.S. requirement for delivery of the Health Part of the General Aircraft Declaration would affect the expanded NQS because this system would be receiving and, if necessary, acting upon this declaration. |
Article 39 Ship sanitation certificates |
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This provision sets out the rules and procedure for the issuance and validity of ship sanitation certificates. Annex 3 of the revised IHR contains the model ship sanitation control exemption certificate and the ship sanitation control certificate, to which such certificates issued by states parties must conform. These rules, thus, apply to the |
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issuance of such certificates by the expanded NQS. |
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PART VII—CHARGES |
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Article 40 Charges for health measures regarding travellers |
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Article 40 contains the rules on charges for the administration of health measures with respect to travelers. Article 40.1 prohibits charges for certain health measures, except with respect to travelers seeking temporary or permanent residence. Article 40.5 allows states parties to seek reimbursement for the costs of health measures listed in Article 40.1 from conveyance operators or owners or insurance sources. Article 40.2 allows charges to be made for other health measures but only under the disciplines provided for in Articles 40.3 and 40.4. These rules would affect whether and how the expanded NQS could charge for any health measures it applies to travelers. |
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Article 41 Charges for baggage, cargo, containers, conveyances, goods or postal parcels |
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Article 41 regulates how states parties can charge for health measures applied to baggage, cargo, containers, conveyances, goods, or postal parcels under these Regulations, there shall be in each State abide by these disciplines. |
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PART VIII—GENERAL PROVISIONS |
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Article 42 Implementation of health measures |
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Health measures taken pursuant to these Regulations shall be initiated and completed without delay, and applied in a transparent and non-discriminatory manner. |
The provision imposes on the expanded NQS duties to implement health measures applied under the IHR without delay, transparently, and in a nondiscriminatory manner. Earlier provisions of the revised IHR subjected their rules to fulfillment of Article 42, so this duty is important in the overall scheme of the revised IHR. |
Article 43 Additional health measures |
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Such measures shall not be more restrictive of international traffic and not more invasive or intrusive to persons than reasonably available alternatives that would achieve the appropriate level of health protection.
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Article 43 is a very important provision in the revised IHR, and thus for the expanded NQS. This provision would allow the expanded NQS to apply health measures that (1) achieve the same or greater level of health protection than WHO recommendations; or (2) are otherwise prohibited by specified provisions of the revised IHR. Implementing such additional health measures has to be done in a way that is not otherwise inconsistent with the revised IHR. Further, states parties are required to base such additional health measures on scientific principles and scientific evidence of a risk to human health, or where the scientific evidence is insufficient on available information, including information from WHO and other relevant international organizations. Article 43.1 also mandates that any additional health measure not be (1) more restrictive of international traffic, and (2) not more intrusive or invasive to persons than reasonably available alternative measures that would achieve the level of health protection sought. |
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measures under paragraph 2 of Article 23, paragraph 1 of Article 27, paragraph 2 of Article 28 and paragraph 2(c) of Article 31, States Parties shall base their determinations upon:
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WHO the public health rationale and scientific information supporting the additional health measure and reviewing the additional health measure within 90 days to assess whether it should still be applied. |
Implementation of additional health measures under Article 43 creates the possibility that (1) WHO may ask the state party to cease application of such measure (Article 43.4); and (2) another state party affected by the additional health measure may seek consultations about the measure (Article 43.7). |
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This article is important to the expanded NQS for a number of reasons, the most important being: (1) it allows states parties to adopt health measures that are more protective than specific measures provided for in the IHR or recommended by WHO; (2) it applies disciplines on the adoption of additional measures that require scientific evidence and the least restrictive/instrusive measures possible; and (3) it sets up a process through which such additional measures can be subjected to international scrutiny by WHO and other states parties. |
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Article 44 Collaboration and assistance |
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Article 44.1 establishes some general duties to collaborate on disease prevention, control, and response; and these duties do not raise significant concerns for plans for the expanded NQS. Perhaps the most important of these general obligations concerns making sure that domestic laws are formulated to allow the implementation of the revised IHR. |
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Article 45 Treatment of personal data |
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Article 45.1 concerns obligations to keep personal information gathered in implementing the IHR confidential, except where sharing of such information is essential for the purposes of assessing and managing a public health risk (Article 45.2). Overall, Article 45 raises the need for the expanded NQS to develop and implement systems of keeping personally identifiable information confidential. |
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Article 46 Transport and handling of biological substances, reagents and materials for diagnostic purposes |
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States Parties shall, subject to national law and taking into account relevant international guidelines, facilitate the transport, entry, exit, processing and disposal of biological substances and diagnostic specimens, reagents and other diagnostic materials for verification and public health response purposes under these Regulations. |
This provision contains a requirement that states parties facilitate the movement of biological substances, specimens, reagents, and other materials needed for verifying and responding to public health events and risks. This obligation might be particularly important for the expanded NQS because of the CDC’s role of participating in international disease verification and response activities. |
PART IX—THE IHR ROSTER OF EXPERTS, THE EMERGENCY COMMITTEE AND THE REVIEW COMMITTEE (Articles 47–53: Not relevant for the NQS’ relationship with the revised IHR) |
PART X—FINAL PROVISIONS (only the relevant articles) Article 54 Reporting and review |
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The expanded NQS would be called upon to provide information to fulfill the United States’ duty under this article to report on its implementation of the IHR. |
Article 57 Relationship with other international agreements |
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Article 57.1 is potentially important should the expanded NQS find itself confronted with a choice between compliance with the revised IHR and compliance with another international legal regime. The likelihood of direct conflicts between the revised IHR and other international legal regimes is not significant for many reasons, including the flexibility built into the revised IHR that allows for health measures to be applied pursuant to other international agreements. |
Article 57.2 allows the United States to develop agreements or arrangements with other states parties to facilitate the application of |
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the IHR. This provision would accommodate the United States concluding agreements to post federal quarantine resources in other countries as part of the plan to expand the NQS. |
Article 62 Reservations |
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This provision would only affect the expanded NQS in the event that the United States made reservations to the revised IHR. At present, the United States has only indicated that it would make one reservation addressing implementation of the revised IHR under the U.S. federal system of government. |
States objecting to a reservation should provide the Director-General with reasons for the objection.
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Revised IHR |
Implications for Plans to Expand the National Quarantine System (NQS) |
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ANNEX 3
TABLE F.4 Analysis of the WTO’s Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement): Implications for Plans to Expand the National Quarantine System
Article of the SPS Agreement |
Implications for the Plans to Expand the National Quarantine System (NQS) |
Article 1 General Provisions |
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As contemplated, the federal government would task the expanded NQS to address threats to U.S. public health posed by goods imported into the United States. Thus, the expanded NQS would apply sanitary and phytosanitary (SPS) measures as defined by the SPS Agreement. Annex A.1 of the SPS Agreement defines a SPS measure to include any measure applied to protect human life or health from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages, or feedstuffs or from risks arising from diseases carried by animals, plants, or products thereof, or from risks arising from the entry and the establishment of pests. All these risks would be part of the mandate of an expanded NQS, thus making the SPS Agreement relevant to the responsibilities the expanded NQS will undertake. |
Article 2 Basic Rights and Obligations |
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Article 2.1: This provision states that all WTO members have the right to take SPS measures to protect human health. The expansion of the NQS by the federal government would be an exercise of this sovereign right. Article 2.1 conditions the exercise of this right, however, on WTO members applying SPS measures consistently |
Article of the SPS Agreement |
Implications for the Plans to Expand the National Quarantine System (NQS) |
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with the other provisions in the SPS Agreement. Article 2.2: This provision sets out the basic science-based disciplines with which SPS measures have to comply—the measures have to be necessary to protect human health, be based on scientific principles, and not maintained without sufficient scientific evidence. SPS measures applied by the expanded NQS will, thus, need to be scientifically grounded and justified for the measure to survive scrutiny under the SPS Agreement. Article 2.3: This provision contains the basic trade-related disciplines that the SPS Agreement applies to the SPS measures of WTO members. The expanded NQS’ application of SPS measures will have to comply with not only the science-based disciplines but also the trade-related disciplines in the SPS Agreement. Article 2.4: This provision provides that, if a WTO member’s SPS measure complies with the SPS Agreement, that measure is deemed to comply with the provisions of GATT. Thus, the application of SPS measures by the expanded NQS that comply with the SPS Agreement will not be vulnerable to claims that the measures violate GATT. |
Article 3 Harmonization |
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Article 3 contains the harmonization disciplines of the SPS Agreement. These provisions involve obligations and incentives for WTO member states to use international standards, guidelines, and recommendations as the basis for their SPS measures. Thus, the expanded NQS is under an obligation to base the SPS measures it |
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applies on existing international standards, if they exist. Conforming national measures to international standards means that the measures comply with the SPS Agreement. |
The expanded NQS can apply a SPS measure that is more protective of health (and restrictive of trade) than an existing international standard if it complies with the other rules of the SPS Agreement (the science-based and trade-related disciplines). Particularly, the more protective measure must have a scientific basis. |
Article of the SPS Agreement |
Implications for the Plans to Expand the National Quarantine System (NQS) |
coordinate efforts in this regard with the relevant international organizations. |
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Article 4 Equivalence |
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This article of the SPS Agreement would require the expanded NQS to recognize the SPS measures of exporting countries as equivalent if the exporting countries demonstrate objectively to the United States that its measures achieve the level of protection selected as appropriate by the United States. Whether this obligation to recognize the SPS measure of two other WTO members as equivalent restricts the sovereignty of the United States significantly is doubtful because the importing WTO member (here, the United States) remains in control of the process of granting equivalence status to the SPS measures of WTO members exporting products to the United States. The United States has, however, entered into mutual recognition agreements and arrangements with other WTO members, such as the EU; so these equivalence pacts could affect the way in which the NQS deals with products from such countries. |
Article 5 Assessment of Risk and Determination of the Appropriate Level of Sanitary or Phytosanitary Protection |
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This article contains a number of important provisions from the perspective of the operation of the expanded NQS: Risk assessment: SPS measures have to be based on a risk assessment (Article 5.1) that has to take into account a number of factors (Articles 5.2 and 5.3). The expanded NQS cannot, thus, |
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apply a SPS measure without having based that measure on a risk assessment (but not necessarily a risk assessment carried out by the NQS but by any federal government agency, other WTO member, or nonstate actor). Trade-related disciplines: Articles 5.4, 5.5, and 5.6 contain trade-related disciplines to ensure that SPS measures applied are the least trade-restrictive measures possible and do not constitute arbitrary or unjustified discrimination or a disguised restriction on international trade. Precautionary principle: Article 5.7 allows WTO members to apply provisionally a SPS measure when the scientific evidence is insufficient or inconclusive, as long as the WTO member applying such a provisional measure continues to try to obtain more information and reviews the provisional measure periodically. Transparency: Article 5.8 imposes a duty of transparency on a WTO member with respect to SPS measures that it applies because it requires such WTO member to provide information to other WTO members that request information about SPS measures applied to their exports. |
Article of the SPS Agreement |
Implications for the Plans to Expand the National Quarantine System (NQS) |
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Article 6 Adaptation to Regional Conditions, Including Pest- or Disease-Free Areas and Areas of Low Pest or Disease Prevalence |
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From the perspective of the expanded NQS, Article 6 would require that SPS measures applied by the expanded NQS are adapted to the SPS characteristics of the areas from which products come. This obligation exists to prevent WTO members from applying SPS measures to products from regions where the disease or pest in question does not exist (i.e., no public health justification supports the imposition of a SPS measure to prevent the importation of a disease from a country or region where that disease does not exist). Exporting WTO members have transparency obligations to support the compliance of importing WTO members with this requirement of the SPS Agreement. |
Article of the SPS Agreement |
Implications for the Plans to Expand the National Quarantine System (NQS) |
Article 7 Transparency |
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Members shall notify of changes in their sanitary or phytosanitary measures and shall provide information on their sanitary or phytosanitary measures in accordance with the provisions of Annex B. |
Transparency is an important general principle of the SPS Agreement (and all WTO agreements), so the expanded NQS will have to operate in conformity with its requirements. Annex B of the SPS Agreement contains the detailed set of rules concerning transparency with which the expanded NQS should be concerned. |
Article 8 Control, Inspection and Approval Procedures |
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Members shall observe the provisions of Annex C in the operation of control, inspection and approval procedures, including national systems for approving the use of additives or for establishing tolerances for contaminants in foods, beverages or feedstuffs, and otherwise ensure that their procedures are not inconsistent with the provisions of this Agreement. |
Article 8 combined with Annex C imposes on WTO members obligations in how they operate their procedures for control, inspection, and approval of goods pursuant to the application of SPS measures. These obligations would affect how the expanded NQS would operate its control, inspection, and approval procedures concerning SPS measures it applied. |
Article 9 Technical Assistance |
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This provision is not directly relevant to the federal government’s to expand the NQS because those plans do not, to Consultant’s knowledge, involve providing technical assistance to developing-country WTO members concerning their application of SPS measures. The federal government could, however, involve the expanded NQS in providing technical assistance to developing-country WTO members. |
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Article 10 Special and Differential Treatment |
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This provision requires WTO members to “take account of” the special needs of developing-country and particularly least-developed-country WTO members in the application of SPS measures. This obligation would apply to the expanded NQS, but the obligation does not significantly affect U.S. sovereignty in terms of the SPS measures it applies. |
Article of the SPS Agreement |
Implications for the Plans to Expand the National Quarantine System (NQS) |
Article 11 Consultations and Dispute Settlement |
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This provision gives jurisdiction over disputes under the SPS Agreement to the WTO Dispute Settlement Understanding (DSU). The importance of this provision for the expanded NQS is that the obligations of the SPS Agreement can be enforced by other countries through the DSU, which heightens the importance for the United States of the expanded NQS complying with the requirements of the SPS Agreement. |
Article 12 Administration |
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This provision addresses the establishment and responsibilities of the SPS Committee and is not directly relevant to the expanded NQS’ anticipated responsibilities. |
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Article of the SPS Agreement |
Implications for the Plans to Expand the National Quarantine System (NQS) |
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Article 13 Implementation |
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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 |
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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. |
Article of the SPS Agreement |
Implications for the Plans to Expand the National Quarantine System (NQS) |
ANNEX A: DEFINITIONSc
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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Article of the SPS Agreement |
Implications for the Plans to Expand the National Quarantine System (NQS) |
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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 |
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Enquiry points |
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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.
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Notification procedures |
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Article of the SPS Agreement |
Implications for the Plans to Expand the National Quarantine System (NQS) |
General reservations |
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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. |
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