Will any specific or additional funding be required for the U.S. government to comply with IHR (2005)?
To meet the requirements of IHR (2005), the United States will use strong state and local reporting networks to receive information about events of concern. Additional resources may be required for enhanced and maintain surveillance, inspection, or screening programs related to IHR (2005). These needs will become clearer as IHR implementation continues.
How are the IHR (2005) different than the previous regulations?
The IHR (1969) were limited to the notification of cases of cholera, plague and yellow fever. WHO's actions under the previous Regulations depended on receiving official notification of cases from an affected country. There was little in them that fostered collaboration between WHO and a State Party in which outbreaks of disease with the potential to spread internationally were occurring. The IHR (1969) provided primarily for the implementation of specified maximum measures in response to outbreaks of the previously mentioned diseases.
In contrast, the IHR (2005) have a broad scope, provide for the use of a wide range of information, and emphasize collaborative actions between States Parties and WHO in the identification and assessment of events and response to public health risks and emergencies. In WHO's coordination of the international response to public health emergencies of international concern, maximum measures are replaced by formally recommended and context-specific temporary health measures, tailored to the actual threat faced.
In addition to the reservation of "federalism" that the US registered when accepting IHR (2005), the US government also specified three understandings related to sources of incidents, reporting risks outside its boundaries, and judicially enforceable private rights. Can you elaborate on these understandings?
The United States has accepted the IHR (2005) with the reservation that it will implement them in line with U.S. principles of federalism. The U.S. Constitution establishes a government based on “federalism,” a system in which power or authority is shared as between the federal and the state (and local) governments. In general, the federal government exercises public health authority “concurrently” with state governments.
In addition, the U.S. Government submitted three understandings, setting forth its views that
(1) incidents that involve the natural, accidental or deliberate release of chemical, biological or radiological materials are notifiable under the IHRs;
(2) countries that accept the IHRs are obligated to report potential public health emergencies that occur outside their borders to the extent possible; and
(3) the IHRs do not create any separate private right to legal action against the federal government.
Do IHR (2005) affect the Global Health Security Initiative in any way or work in tandem with it? If so, how?
The International Health Regulations (2005) are an international framework for preventing and controlling potential public health emergencies of international concern. They represent a key tool in enhancing global health security and are therefore of interest to Global Health Security Initiative (GHSI). The GHSI can play a catalyst role in addressing various implementation issues, in supporting WHO, and sharing lessons learned to assist member states of the GHSI and other countries.
Specific criteria have been described for determining public health threats that must be reported under IHR (2005). Do you believe these regulations (and the infrastructures that support them) are also valuable to help determine (and communicate internationally) that a public health event is NOT a Public Health Emergency of International Concern (PHEIC)?
IHR (2005) specify that the WHO Director-General makes the final determination about whether an event is a PHEIC. The IHR (2005) indicate that in making this determination, the Director-General considers the following: a) information provided by the WHO member state; b) the decision algorithm contained in Annex 2 of the IHR (2005) document; c) the advice of the WHO Emergency Committee; d) scientific principles and the available scientific evidence and other relevant information; and e) an assessment of the risk to human health, of the risk of international spread of disease, and of the risk of interference with international traffic. WHO will communicate its decision and the rationale for the decision to member states through each country's National Focal Point (in the case of the United States, this is the Department of Health and Human Services’ Secretary’s Operations Center (SOC)). The SOC would communicate this information to US government agencies. All information on final determinations of PHEIC and non-PHEIC will be communicated by WHO.
Would a public health event such as the heat wave that occurred in Europe in 2003 be considered a PHEIC?
The 2003 heat wave in Europe was an international event and 11 European countries were affected, meeting the first two criteria, but a similar event in the United States likely would not be reported to WHO.
To determine whether an event would be reportable to WHO under IHR (2005), the circumstances of the event would have to be assessed within the context of the decision algorithm in Annex 2 of the IHR (2005) document. To be considered a potential Public Health Emergency of International Concern (PHEIC), the event would have to meet two of the four following criteria (questions). Annex 2 offers guidance in interpreting the questions:1) Is the public health impact of the event serious?
2) Is the event unusual or unexpected?
3) Is there a significant risk of international spread?
4) Is there a significant risk of international travel or trade restrictions?
Is avian flu considered a reporting requirement, in addition to the other diseases listed on the IHR (2005)?
New types of human influenza, or novel influenza, are required to be reported under the IHR (2005). Additionally, the US government reports to WHO any human infections caused by avian influenza strains.
State and territorial epidemiologists, in conjunction with public health laboratories, report to CDC all human infections with influenza A viruses that are different from currently circulating human influenza H1 and H3 viruses. These viruses include those that are sub-typed as non-human in origin and those that are unsub-typable with standard methods and reagents. Any other new viruses that met 2 of the four criteria for a Public Health Emergency of International Concern (PHEIC) are also reported under IHR (2005).
To facilitate reporting, the Council of State and Territorial Epidemiologists (CSTE) drafted and approved in 2007 this reporting requirement http://www.cste.org/PS/2007ps/2007psfinal/ID/07-ID-06.pdf
Additional background on avian and human influenza viruses: http://www.cdc.gov/flu/avian/gen-info/facts.htm.
West Nile Virus is not transmittable from person to person, yet it is listed as an example of a reportable disease under IHR (2005). Can you explain why?
Introduction of West Nile fever into the United States has caused concern for some WHO Member States who wonder if the virus could be similarly introduced into their country. They asked for information about disease activity in locations that posed a potential risk. Introduction of West Nile Virus into the United States met the following criteria in Annex 2 of the IHR (2005) document:
a) the public health impact of the event was serious (high mortality in cases with neurological disease),
b) the event was unexpected and unusual (first occurrence of the disease in the U.S.),
c) the event had an adverse effect on international travel (some travelers at the time were concerned about visiting the U.S.)
What countries have agreed to comply with the IHR (2005)?
All 194 WHO Member States have agreed to IHR (2005).
WHO is the best source of information about which countries have agreed to comply: http://www.who.int/csr/ihr/en/
What is the role of HHS under the IHR (2005)?
The U.S. Department of Health and Human Services (HHS) has assumed the lead role for the U.S. government in carrying out the requirements of IHR (2005). The HHS’ Secretary’s Operations Center (SOC) is the central body responsible for reporting events to the WHO Secretariat.
Given the importance of potential zoonotic and/or epizootic diseases, and that these can also involve wildlife (including exotic animals, as in the monkeypox example), why isn’t the Department of Interior on the list of partners along with USDA (domestic animals)? Both the U.S. Fish and Wildlife Service and the U.S. Geological Survey could have important roles in identifying Public Health Emergencies of International Concern.
The 20 Federal agencies currently identified as partners in the IHR implementation are those that were involved in the U.S. government’s final approval process of the IHR (2005). The Department of Health and Human Services (HHS) is responsible for coordinating the IHR-related communications across HHS and non-HHS agencies to implement the Regulations. It is expected that all Federal agencies of the U.S. government that are appropriate to respond to a specified event will be involved as events are identified.
The IHR (2005) specify that any U.S. Governmental agency is responsible for reporting a PHEIC. Has the CDC established a central point for reporting PHEIC?
In the United States, the Department of Health and Human Services (HHS) has assumed the lead role in carrying out the reporting requirements of the IHR (2005). The HHS Secretary's Operations Center (SOC) is the central body responsible for reporting events to WHO. This requires close coordination of reports from across the US government. For the past several months, CDC and many other US government agencies have been collaborating with HHS to establish the protocols and procedures for communication and coordination of reports.
California often experiences instances where candy imported from Mexico tests high for lead that can result in poisonings in children. Would this be reportable under the IHR (2005)? What kind of assistance or response could CDC provide states that encounter this situation?
To determine whether an event would be reportable under the IHR (2005), the circumstances of the event would have to be assessed within the context of the decision algorithm in Annex 2 of the IHR (2005) document. To be considered a potential Public Health Emergency of International Concern (PHEIC), the event would have to meet two of the four criteria (questions) in the decision algorithm.
1) Is the public health impact of the event serious?
2) Is the event unusual or unexpected?
3) Is there a significant risk of international spread?
4) Is there a significant risk of international travel or trade restrictions? This event seems to meet the following criteria:
Question # 1 could be answered with a "Yes" since the scenario involves a toxic material that has the potential to contaminate a population (in this case, the population close to the border) or large geographic area.
Question # 3 could be answered with a "Yes" since the contaminated candy is exported to the U.S. and possibly other countries.
Question #4 could be answered with a "Yes" because the likely response is for the contaminated candy to be identified as dangerous and subject to regulatory actions by appropriate U.S. agencies.
CDC is committed to providing accurate and reliable education and outreach information to the general public, state and local health officials, and health care professionals. CDC also funds state and local health departments to conduct comprehensive childhood lead poisoning prevention efforts, which include identification of lead exposure sources in children. A working group of nine federal agencies has been convened to develop a comprehensive strategy to control sources of lead in food and consumer products through interagency collaboration and cooperation.
The Food and Drug Administration (FDA) is the agency responsible for taking regulatory actions in lead candy incidents. The FDA has issued warnings in the past about this type of problem and is developing tighter guidelines for manufacturers, importers, and distributors of imported candy: http://www.cdc.gov/nceh/lead/tips/candy.htm
I understand CDC is no longer responsible for issuing a ship's Derat Certificate. As I read in IHR (2005), the certificate will take on the form as per the model offered in Annex III. If the certificate is still required, who will now be responsible for issuing the Derat certificate in the US?
The IHR (2005) render the Deratting Certificates and inspections invalid and replace them with Ship Sanitation Certificates, as appropriate. The last Derat Certificate was issued on June 14, 2007, and is valid until December 14, 2007. CDC's Vessel Sanitation Program can be contacted (email@example.com) for questions about sanitary inspections on cruise ships. Currently, the United States does not routinely require inspection certificates, but reserves the right to inspect any vessel in response to a public health event.
My understanding is the countries that have agreed to comply with IHR (2005) will provide to WHO a list of authorities who can issue the new Ship Sanitation Certificates. Will there be a new authority in the US other than CDC authorized to issue the new certificates? If a US ship is issued a certificate from a foreign authority, will it be recognized in the US should you wish to inspect a vessel?
Ships need to contact each port of entry scheduled during the voyage to assess their individual requirements.
The IHR (2005) requirements for inspections of vessels with international itineraries include mention of the issuance of the Ship Sanitation Control certificate/Ship Sanitation Control Exemption Certificate. Has the "competent authority" been established in the U.S. to conduct these inspections?
The "competent authority" for overall public health issues at U.S. ports of entry is the CDC Quarantine Station in each port of entry. The CDC Vessel Sanitation Program continues to have responsibility for sanitation issues on cruise ships, including issuance of Ship Sanitation Certificates. The question regarding who will conduct the inspections for cargo ships and other maritime vessels (excluding cruise ships) is currently being discussed. If a decision is made to implement a new sanitation inspection program for cargo and other vessels, the next steps will be to identify the number and types of staff needed and resources required to implement the new program.
What criteria should be adopted to allow for clearance of a person with TB to board an international flight?
The WHO has released Tuberculosis and Air Travel Guidelines for prevention and control which provides guidelines on the transmission of TB during air travel and specific recommendations that are applicable to all domestic and international airlines worldwide.