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Appendix F: International Legal Considerations for the Quarantine Station Expansion
Pages 199-304

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From page 199...
... 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)
From page 200...
... 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.
From page 201...
... As a federal system, the United States' acceptance of international legal obligations is occasionally affected by federalism. The revised International Health Regulations (IHR)
From page 202...
... 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.
From page 203...
... 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.
From page 204...
... 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.
From page 205...
... 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.
From page 206...
... 206 QUARANTINE STATIONS AT PORTS OF ENTRY BOX F.1 The Revised IHR's Decision Instrument (Annex 2) Any case of smallpox, polio, human influenza caused by a new sub-type, and SARS must be notified to WHO under the revised IHR.
From page 207...
... 207 APPENDIX F 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.
From page 208...
... 208 QUARANTINE STATIONS AT PORTS OF ENTRY 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.
From page 209...
... . 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)
From page 210...
... . Personal information States parties may require as a condition of entry for travelers certain information about the travelers' itinerary and destination and the oppor
From page 211...
... 211 APPENDIX F tunity to review health documents required under the revised IHR (e.g., yellow fever vaccination certificate) (Article 23.2[a]
From page 212...
... 212 QUARANTINE STATIONS AT PORTS OF ENTRY 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.
From page 213...
... ; Health Part of the General Aircraft Declaration (Article 38 and Annex 9) ; and Ship Sanitation Control Exemp
From page 214...
... 214 QUARANTINE STATIONS AT PORTS OF ENTRY tion Certificate and Ship Sanitation Control Certificate (Article 39 and Annex 3)
From page 215...
... 215 APPENDIX F 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.
From page 216...
... 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.
From page 217...
... 217 APPENDIX F 4. INTERNATIONAL TRADE LAW The second important area of treaty law applicable to the expansion of the NQS is international trade law.
From page 218...
... 218 QUARANTINE STATIONS AT PORTS OF ENTRY 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.
From page 219...
... 219 APPENDIX F 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)
From page 220...
... . The second situation concerns the application of a SPS measure that requires control at the level of the production of the good.
From page 221...
... 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]
From page 222...
... 222 QUARANTINE STATIONS AT PORTS OF ENTRY 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)
From page 223...
... TABLE F.1 Public Health-Related Civil and Political Rights in the ICCPR Express/Implicit Recognition of Article Content of the Civil and Political Right Public Health Public Health Acts Affecting Right 09.1 Everyone has the right to liberty and security of Implicit -Detention for medical examination person. No one shall be subjected to arbitrary arrest -Quarantine or detention.
From page 224...
... 224 QUARANTINE STATIONS AT PORTS OF ENTRY 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.
From page 225...
... 225 APPENDIX F 6. INTERNATIONAL LEGAL CONSIDERATIONS CONCERNING "FORWARD DEPLOYMENT" OF THE EXPANDED NQS 0 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.
From page 226...
... 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.
From page 227...
... 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 · Measures against individuals must be implemented with full · No treatment of individuals that constitutes torture or cruel, respect for the dignity, human rights, and fundamental freedoms of inhuman, or degrading treatment or punishment (ICCPR, Art.
From page 228...
... TABLE F.2 Continued 228 Positive Obligationsa Negative Obligationsb in a nondiscriminatory fashion, and be published at least baggage, or isolation or quarantine, except for travelers seeking ten days in advance of any levy (IHR 2005, Arts.
From page 229...
... · SPS measures that differ from applicable international standards, guidelines, and recommendations must have a scientific justification (SPS Agreement, Art.
From page 230...
... . Annex B contains traffic, except for document requirements concerning the public rules concerning the publication of regulations, enquiry points, and health status of goods pursuant to applicable international notification procedures.
From page 231...
... ; (2) a ship which passes through waters within its Certificates and Ship Sanitation Control Certificates are issued in jurisdiction without calling at a port or on the coast; and (3)
From page 232...
... . ·States parties shall note on the Ship Sanitation Control Certificate when control measures cannot be satisfactorily completed (IHR 2005, Art.
From page 233...
... ·States parties shall develop, strengthen, and maintain the capacity to detect, assess, notify, and report public health events in accordance with the IHR (IHR 2005, Art.
From page 234...
... . NOTE: Areas of international law covered: Revised International Health Regulations (IHR 2005)
From page 235...
... 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 The definition of "disease" in the revised IHR is important to the origin or source, that presents or could present significant harm expanded NQS because this definition helps establish the scope of the to humans.
From page 236...
... TABLE F.3 Continued 236 Revised IHR Implications for Plans to Expand the National Quarantine System (NQS)
From page 237...
... from, relevant sectors of the administration of the State Party concerned, including those responsible for surveillance and reporting, points of entry, public health services, clinics and hospitals and other government departments.
From page 238...
... Information received by WHO under this paragraph shall be handled in accordance with Articles 11 and 45 where appropriate. Article 6 Notification 1.
From page 239...
... communication available, by way of the National IHR Focal that may constitute a public health emergency of international Point, and within 24 hours of assessment of public health concern within the time limits specified in the revised IHR. Further, information, of all events which may constitute a public Article 6.1 requires each part of the expanded NQS to be able to health emergency of international concern within its territory utilize the decision instrument contained in Annex 2 of the revised in accordance with the decision instrument, as well as any IHR.
From page 240...
... Before taking governmental information concerning disease events in the United any action based on such reports, WHO shall consult with States, requiring input from the expanded NQS if WHO seeks to and attempt to obtain verification from the State Party in consult with the United States concerning verification of such reports. whose territory the event is allegedly occurring in accordance with the procedure set forth in Article 10.
From page 241...
... Article 10 Verification 1. WHO shall request, in accordance with Article 9, verification The Article 10 verification process affects the expanded NQS because from a State Party of reports from sources other than the nature of information required to be provided to WHO under notifications or consultations of events which may constitute Article 10.2 would, in all likelihood, involve various components of a public health emergency of international concern allegedly the expanded NQS.
From page 242...
... The expanded NQS intergovernmental organizations, as soon as possible and by will have to develop communication mechanisms to distribute the most efficient means available, in confidence, such public information provided by WHO that is relevant for addressing public health information which it has received under Articles 5 to health problems and events in the United States. 10 inclusive and which is necessary to enable States Parties to respond to a public health risk.
From page 243...
... provisions, shall not make this information generally available to other States Parties, until such time as: (a) the event is determined to constitute a public health emergency of international concern in accordance with Article 12; or (b)
From page 244...
... If the Director-General considers, based on an assessment upon by the CDC to participate in such a consultation process and/or under these Regulations, that a public health emergency of in the Article 49 procedure mentioned in Articles 12.2 and 12.3. international concern is occurring, the Director-General shall consult with the State Party in whose territory the event arises regarding this preliminary determination.
From page 245...
... (a) information provided by the State Party; (b)
From page 246...
... TABLE F.3 Continued 246 Revised IHR Implications for Plans to Expand the National Quarantine System (NQS) the State Party may request a further extension not exceeding also call on the resources and expertise of the expanded NQS under two years from the Director-General, who shall make the Article 13.4 to provide support for WHO-coordinated response decision, taking into account the technical advice of the activities, perhaps as WHO has historically called on the CDC for Review Committee.
From page 247...
... PART III -- RECOMMENDATIONS Article 15 Temporary recommendations 1. If it has been determined in accordance with Article 12 that Article 15 empowers the WHO Director-General to issue temporary a public health emergency of international concern is recommendations to states parties to assist them in responding to occurring, the Director-General shall issue temporary public health emergencies of international concern.
From page 248...
... Article 16 Standing recommendations WHO may make standing recommendations of appropriate Article 16 empowers the WHO Director-General to issue standing health measures in accordance with Article 53 for routine or recommendations concerning health measures to be applied routinely periodic application. Such measures may be applied by States or periodicly.
From page 249...
... interference with international traffic. WHO may, in accordance the expanded NQS would need to have sufficient national legal with Article 53, modify or terminate such recommendations, as authority to implement such recommendations.
From page 250...
... TABLE F.3 Continued 250 Revised IHR Implications for Plans to Expand the National Quarantine System (NQS) Article 18 Recommendations with respect to persons, conveyances, containers, goods, cargo, baggage and postal parcels 1.
From page 251...
... connection with a specific public health threat information concerning sources of infection or contamination at points of entry. (continued)
From page 252...
... (b) the issuance of Ship Sanitation Control Exemption Certificates only; and Under Article 20.4, the United States could request the WHO to (c)
From page 253...
... entering into bilateral or multilateral agreements or arrangements concerning prevention or control of international transmission of disease at ground crossings in accordance with Article 57; and (b) joint designation of adjacent ground crossings for the capacities in Annex 1 in accordance with paragraph 1 of this Article.
From page 254...
... be responsible for the supervision of any deratting, disinfection, disinsection or decontamination of baggage, cargo, containers, conveyances, goods, postal parcels and human remains or sanitary measures for persons, as appropriate under these Regulations; (d) advise conveyance operators, as far in advance as possible, of their intent to apply control measures to a conveyance, and shall provide, where available, written information concerning the methods to be employed; (e)
From page 255...
... information concerning the traveller's destination so additional health measures to suspect or affected travelers, should use that the traveller may be contacted; the least intrusive and invasive medical examination that would (ii) information concerning the traveller's itinerary to achieve the public health objective.
From page 256...
... TABLE F.3 Continued 256 Revised IHR Implications for Plans to Expand the National Quarantine System (NQS) area or other possible contacts with infection or Articles 23.3, 23.4, and 23.5 contain mandatory obligations that contamination prior to arrival, as well as review of the affect how the expanded NQS would operate with respect to travelers.
From page 257...
... practitioners of these requirements in accordance with the law of the State Party.
From page 258...
... TABLE F.3 Continued 258 Revised IHR Implications for Plans to Expand the National Quarantine System (NQS) must put in writing the control measures applied and the reasons therefore.
From page 259...
... (b) a ship which passes through waters within its jurisdiction without calling at a port or on the coast; and (c)
From page 260...
... ; and (b) in the case of a ship, the evidence found and the control measures required shall be noted in the Ship Sanitation Control Certificate.
From page 261...
... the capacity to receive and act on such information provided by 3. Whenever practicable and subject to the previous paragraph, officers and pilots of ships and aircraft.
From page 262...
... TABLE F.3 Continued 262 Revised IHR Implications for Plans to Expand the National Quarantine System (NQS)
From page 263...
... cargo shall be removed from that vicinity, unless authorized by the competent authority; and (d) when all health measures required by the competent authority have been completed, the aircraft or ship may, so far as such health measures are concerned, proceed either to the airport or port at which it was due to land or berth, or, if for technical reasons it cannot do so, to a conveniently situated airport or port.
From page 264...
... TABLE F.3 Continued 264 Revised IHR Implications for Plans to Expand the National Quarantine System (NQS) point of entry at destination, if known, of the traveller's traveler to continue on an international voyage, then it must inform expected arrival.
From page 265...
... accordance with its national law and to the extent necessary quarantine, public health observation) (Article 31.2)
From page 266...
... TABLE F.3 Continued 266 Revised IHR Implications for Plans to Expand the National Quarantine System (NQS) Chapter IV -- Special provisions for goods, containers and container loading areas Article 33 Goods in transit Subject to Article 43 or unless authorized by applicable The general rule in Article 33 is that goods (excluding live animals)
From page 267...
... inspections, to assess the sanitary condition of container loading areas and containers in order to ensure that the obligations contained in these Regulations are implemented.
From page 268...
... TABLE F.3 Continued 268 Revised IHR Implications for Plans to Expand the National Quarantine System (NQS) legitimately ignore.
From page 269...
... to dispense with the submission of the Maritime Declaration of Health by all arriving ships; or (b) to require the submission of the Maritime Declaration of Health under a recommendation concerning ships arriving from affected areas or to require it from ships which might otherwise carry infection or contamination.
From page 270...
... to dispense with the submission of the Health Part of the Aircraft General Declaration by all arriving aircraft; or (b) to require the submission of the Health Part of the Aircraft General Declaration under a recommendation concerning aircraft arriving from affected areas or to require it from aircraft which might otherwise carry infection or contamination.
From page 271...
... 7. If the conditions under which control measures are carried out are such that, in the opinion of the competent authority for the port where the operation was performed, a satisfactory result cannot be obtained, the competent authority shall make a note to that effect on the Ship Sanitation Control Certificate.
From page 272...
... Article 40.5 allows states public health: (a) any medical examination provided for in parties to seek reimbursement for the costs of health measures listed these Regulations, or any supplementary examination which in Article 40.1 from conveyance operators or owners or insurance may be required by that State Party to ascertain the health sources.
From page 273...
... 4. The tariff, and any amendment thereto, shall be published at least 10 days in advance of any levy thereunder.
From page 274...
... 2. In determining whether to implement the health measures referred to in paragraph 1 of this Article or additional health Article 43.2 and 43.5 impose other requirements, namely providing
From page 275...
... 4. After assessing information provided pursuant to paragraph 3 and 5 of this Article and other relevant information, WHO may request that the State Party concerned reconsider the application of the measures.
From page 276...
... TABLE F.3 Continued 276 Revised IHR Implications for Plans to Expand the National Quarantine System (NQS)
From page 277...
... the need for the expanded NQS to develop and implement systems of 2. Notwithstanding paragraph 1, States Parties may disclose keeping personally identifiable information confidential.
From page 278...
... TABLE F.3 Continued 278 Revised IHR Implications for Plans to Expand the National Quarantine System (NQS)
From page 279...
... international legal regimes is not significant for many reasons, 2. Subject to paragraph 1 of this Article, nothing in these including the flexibility built into the revised IHR that allows for Regulations shall prevent States Parties having certain health measures to be applied pursuant to other international interests in common owing to their health, geographical, agreements.
From page 280...
... TABLE F.3 Continued 280 Revised IHR Implications for Plans to Expand the National Quarantine System (NQS)
From page 281...
... formulating reservations should provide the Director-General with reasons for the reservations.
From page 282...
... The Review Committee shall advise the Director-General as soon as possible and in accordance with Article 50 on the practical impact of the reservation on the operation of these Regulations.
From page 283...
... 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 Implications for the Plans to Expand the National Quarantine System Article of the SPS Agreement (NQS)
From page 284...
... TABLE F.4 Continued 284 Implications for the Plans to Expand the National Quarantine System Article of the SPS Agreement (NQS) measure is applied only to the extent necessary to protect with the other provisions in the SPS Agreement.
From page 285...
... 2. Sanitary or phytosanitary measures which conform to applies on existing international standards, if they exist.
From page 286...
... TABLE F.4 Continued 286 Implications for the Plans to Expand the National Quarantine System Article of the SPS Agreement (NQS) coordinate efforts in this regard with the relevant international organizations.
From page 287...
... 2. In the assessment of risks, Members shall take into account apply a SPS measure without having based that measure on a risk available scientific evidence; relevant processes and production assessment (but not necessarily a risk assessment carried out by the methods; relevant inspection, sampling and testing methods; NQS but by any federal government agency, other WTO member, prevalence of specific diseases or pests; existence of pest- or or nonstate actor)
From page 288...
... 288 TABLE F.4 Continued Implications for the Plans to Expand the National Quarantine System Article of the SPS Agreement (NQS) human health risks to which people voluntarily expose themselves.
From page 289...
... Article 6 Adaptation to Regional Conditions, Including Pest- or Disease-Free Areas and Areas of Low Pest or Disease Prevalence 1. Members shall ensure that their sanitary or phytosanitary From the perspective of the expanded NQS, Article 6 would measures are adapted to the sanitary or phytosanitary require that SPS measures applied by the expanded NQS are characteristics of the area -- whether all of a country, part of a adapted to the SPS characteristics of the areas from which country, or all or parts of several countries -- from which the products come.
From page 290...
... TABLE F.4 Continued 290 Implications for the Plans to Expand the National Quarantine System Article of the SPS Agreement (NQS) Article 7 Transparency Members shall notify of changes in their sanitary or phytosanitary Transparency is an important general principle of the SPS measures and shall provide information on their sanitary or Agreement (and all WTO agreements)
From page 291...
... equipment to allow such countries to adjust to, and comply with, sanitary or phytosanitary measures necessary to achieve the appropriate level of sanitary or phytosanitary protection in their export markets.
From page 292...
... TABLE F.4 Continued 292 Implications for the Plans to Expand the National Quarantine System Article of the SPS Agreement (NQS) Article 11 Consultations and Dispute Settlement 1.
From page 293...
... 2. The Committee shall encourage and facilitate ad hoc consultations or negotiations among Members on specific sanitary or phytosanitary issues.
From page 294...
... TABLE F.4 Continued 294 Implications for the Plans to Expand the National Quarantine System Article of the SPS Agreement (NQS) guideline or recommendation as a condition for import, the Member should provide an indication of the reason therefor, and, in particular, whether it considers that the standard is not stringent enough to provide the appropriate level of sanitary or phytosanitary protection.
From page 295...
... Article 13 Implementation Members are fully responsible under this Agreement for the This provision is important for the expanded NQS because it observance of all obligations set forth herein. Members shall reiterates that the SPS Agreement's provisions are obligations that formulate and implement positive measures and mechanisms in must be observed.
From page 296...
... TABLE F.4 Continued 296 Implications for the Plans to Expand the National Quarantine System Article of the SPS Agreement (NQS) ANNEX A: DEFINITIONSc This annex defines many of the important terms and concepts that 1.
From page 297...
... 2. Harmonization -- The establishment, recognition and application of common sanitary and phytosanitary measures by different Members.
From page 298...
... TABLE F.4 Continued 298 Implications for the Plans to Expand the National Quarantine System Article of the SPS Agreement (NQS)
From page 299...
... Members shall ensure that all sanitary and phytosanitary points, and notification procedures. regulationsd which have been adopted are published promptly in such a manner as to enable interested Members to become acquainted with them.
From page 300...
... , apart from the cost of delivery, as to the nationalse of the Member concerned. Notification procedures 5.
From page 301...
... 10. Members shall designate a single central government authority as responsible for the implementation, on the national level, of the provisions concerning notification procedures according to paragraphs 5, 6, 7 and 8 of this Annex.
From page 302...
... 302 TABLE F.4 Continued Implications for the Plans to Expand the National Quarantine System Article of the SPS Agreement (NQS) General reservations 11.
From page 303...
... application has deficiencies, the competent body proceeds as far as practicable with the procedure if the applicant so requests; and that upon request, the applicant is informed of the stage of the procedure, with any delay being explained; (c) information requirements are limited to what is necessary for appropriate control, inspection and approval procedures, including for approval of the use of additives or for the establishment of tolerances for contaminants in food, beverages or feedstuffs; (d)
From page 304...
... TABLE F.4 Continued Implications for the Plans to Expand the National Quarantine System 304 Article of the SPS Agreement (NQS)


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