Travel Restrictions
In light of the rapid spread of the virus, Chinese authorities have imposed strict travel restrictions in the area around Wuhan. China has taken unprecedented steps to help control the virus. Currently, there are at least 16 cities in China that are under travel restrictions and 26 of China's provincial-level jurisdictions are on high health alert. Beijing city government has suspended all inter-province bus service.
But these precautions have not stopped the virus from spreading to areas of China outside of Hubei Province, as well as to other countries. As many as 5 million individuals are reported to have left Wuhan prior to the imposition of intra-China travel restrictions. Neighboring countries have taken swift action to protect their citizens by restricting travel between their countries and China.
On January 29, President Trump designated the Secretary of Health and Human Services to lead an interagency task force on the novel coronavirus. On January 30, 2020, the U.S. Department of State issued a “Level 4: Do Not Travel” travel advisory for China, its highest level of caution over the rapidly spreading virus. Other countries have taken additional measures, including prohibiting foreign nationals traveling from China from entering or transiting their borders and quarantining citizens returning from China. Such sustained human-to-human viral transmission in the United States could have cascading public health, economic, and societal consequences.
While the risk of infection for Americans remained low, on January 31, 2020, the Secretary determined that, as of January 27, 2020, a public health emergency has existed in the United States as a result of confirmed cases of 2019-nCoV under section 319 of the Public Health Service Act. As part of the public health response, the President authorized temporary measures to increase the U.S. government's ability to detect and contain 2019-nCoV beginning at 5:00 p.m. EST on Sunday, February 2, 2020. Amongst these measures, U.S. citizens (and certain classes of aliens) returning to the United States who have been in Hubei Province in the previous 14 days will be subject to up to 14 days of mandatory quarantine to ensure that they received appropriate medical screening—have not contracted the virus and do not pose a public health risk—or receive proper medical care. U.S. citizens (and certain classes of foreign nationals) returning to the United States who have been in the rest of mainland China within the previous 14 days will undergo proactive entry health screening at a select number of ports of entry and up to 14 days of monitoring to ensure they have not contracted the virus and do not pose a public health risk. Pursuant to the President's proclamation, with certain exceptions, the entry of aliens who were physically present within China (excluding the Special Administrative Regions of Hong Kong and Macau) during the 14-day period preceding their entry or attempted entry into the United States has been temporarily suspended.
The CDC is closely monitoring the situation in the United States for person-to-person transmissions in the United States, is conducting enhanced entry screening at the U.S airports where travelers from China are arriving, and is enhancing its general illness response capacity at the 20 ports of entry where CDC quarantine stations are located. CDC is also supporting States in conducting contact investigations of confirmed 2019-nCoV cases identified in the United States. As of January 31, 2020, there has been at least one case of person-to-person transmission in the United States.
During Fiscal Year 2019, an average of more than 14,000 people traveled to the United States from China each day, via both direct and indirect flights. With such numbers, it would put a severe strain on the CDC to require it to both actively monitor all of these travelers and actively contain and arrange care for individuals at risk in the United States. This continues to be the case, even with the temporary travel restrictions, given the scope of the public health response in which CDC is engaged. The virus has spread to 28 countries, including Germany, Japan, Taiwan, and Vietnam, among other countries, and as of February 1, 2020, there were 8 confirmed cases in the United States.
II. Newly Required Data Reporting
By this interim final rule, CDC requires airlines to collect, and within 24 hours of an order by the Director of CDC, submit to CDC certain data regarding passengers and crew arriving from foreign countries for the purposes of health education, treatment, prophylaxis, or other appropriate public health interventions, including travel restrictions.
Need for Contact Data for Public Health Follow-Up
Among the fundamental components of the public health response to the report of a person with a communicable disease is the identification and evaluation of those who may have been exposed. Thus, in order to control the introduction, transmission, and spread of communicable diseases into the United States, such as 2019-nCoV, CDC must be able to identify and locate persons arriving in the United States from a foreign country who may have been exposed to a communicable disease abroad. Another fundamental component of a public health response is identifying and contacting those individuals who may have come in contact with a person with a communicable disease and who may be at risk of contracting the disease as a result of their interactions with such affected persons. The identification and notification of those exposed is an essential first step in providing the exposed access to potentially life-saving medical screening, follow-up, disease prevention measures, including vaccination and other preventive treatments, and medical treatment and supportive care. Preventing secondary cases among contacts, in turn, helps prevent the propagation and spread of disease within the community. Therefore, travelers and the public at large derive direct benefit from a system that ensures that, if an exposure has occurred, health authorities can identify, locate, and notify affected passengers and those individuals who came into contact with them within the incubation period of the disease. Contact tracing is effective at reducing cases of communicable disease at the early stages of a potential outbreak if the contacts are notified as soon after initial exposure as possible. If an efficient contact system is not in place when the first ill passengers arrive, the benefits of the contact tracing are greatly diminished.
CDC, in partnership with State, local, and international public health partners, frequently conducts contact investigations for diseases such as tuberculosis, measles, meningitis, rubella, and viral hemorrhagic fevers. The delays experienced by CDC in collecting, analyzing, processing, and sending information related to ill and exposed travelers to State and local partners have at times been significant, sometimes over several days. Such delays may prevent CDC and State and local partners from providing timely public health interventions designed to educate travelers and prevent additional Start Printed Page 7876transmission. This interim final rule will enable CDC to receive the most useful forms of data in a more timely manner and enable it to more effectively provide critical public health services.
Based on CDC's experience, in order to conduct effective contact tracing of individuals who may be arriving in the United States from abroad, it is critical to have the person's full name, address in the U.S., one or two phone numbers, and email address. In the past, CDC has reviewed the effectiveness of different means of contacting a person. If public health authorities had a valid phone number, the contact rate is between 91 and 100 percent. With only the address, the contact rate plummets to 44 percent. With only the name—currently, a common situation—the contact rate is only eight percent. HHS and CDC have found that a phone number will allow rapid contact with an individual and can substantially improve the public health response to an outbreak. Two phone numbers increase the chance of contacting an individual, even when he or she is traveling. HHS and CDC believe that collecting email addresses will further increase the chance of contacting a person when he or she is traveling. Moreover, especially in an outbreak where CDC and its public health partners will need to conduct a significant amount of contact tracing as quickly as possible, it is critical for CDC to receive the information in a usable electronic form, so that it is easy to process, analyze, and, as necessary, transmit to its public health partners at the State and local levels of government.
By this interim final rule, CDC requires airlines to collect and submit via electronic means to CDC, beginning within 24 hours of an order from the Director, certain data regarding passengers and crew arriving on flights arriving in the United States from foreign countries. CDC believes that this is the only mechanism by which it can efficiently obtain the information it needs for a public health response to outbreaks of communicable disease and that current regulatory requirements are not sufficient, especially in public health emergencies. CDC will exercise enforcement discretion where appropriate. We note that implementation of this interim final rule will entail technical and logistical difficulties for airlines. We are confident that all airlines will make every effort to comply with it. CDC, and the Department of Health and Human Services (HHS) more broadly, will in the exercise of its enforcement discretion take into account the good faith attempts at compliance of any airline which may have difficulty in implementing the interim final rule in a timely fashion.
Currently, 42 CFR 71.20 permits the Director to require individuals to provide contact information as part of public health prevention measures. However, while 42 CFR 71.20 provides the Department with what in many instances are useful authorities, it is not in all cases adequate to address public health emergencies: It would require collection of the information from a large number of individuals, and it does not require a format. Hence, the information may be effectively unusable—thousands of pages of paper documents in non-standardized formats. Thus, it would be inefficient and cumbersome to obtain, organize, review, and appropriately disseminate such information from thousands of individuals, particularly during a public health emergency when time is of the essence. It is more efficient to collect such information from airline carriers, whose numbers are more limited. Moreover, while it might be theoretically possible to collect contact information directly from airline passengers, such a collection—unless conducted at all times for all passengers—would inevitably mean that CDC would not have information to conduct contact tracing and public health follow-ups for those individuals who were on flights at the beginning of or before an outbreak.
In an outbreak, paper records (such as those collected during public health screening programs at ports of entry) and paper customs declarations are inadequate for contact tracing or public health follow-ups. Moreover, customs declarations are not being collected and stored consistently for all travelers at this time, and in some airports they are not required for U.S. travelers. As it is impossible to predict outbreaks, and given that the information from the earliest affected flights would be critical, the ability to obtain information that is continuously collected in an electronic format is extremely useful for responding to the ever-changing disease threat.
CDC's current regulations at 42 CFR 71.4, relating to the transmission of airline passenger, crew, and flight information for public health purposes, specify that airlines “must provide certain information to CDC to the extent that such data are already available and maintained [. . .].” 42 CFR 71.4(a) (emphasis added).[3] However, such data are not always “already available and maintained.” Accordingly, even with the current requirements, CDC sometimes receives information that is not timely, complete, or accurate. The Department of Homeland Security has attempted to help CDC fill the gaps in these data in order to try and make contact with exposed travelers in a timely manner. However, even with this assistance, gaps can still remain and acquiring contact information for large numbers of incoming travelers, as needed during the current response to 2019-nCoV, can rapidly become impracticable.
Under this interim final rule, CDC envisions that information will be provided by carriers and shared with CDC using the procedures currently in effect with respect to data that is provided to CDC pursuant to 42 CFR 71.4. Specifically, DHS will assist HHS in facilitating the transmission of the requested information using the existing data-sharing infrastructure in place between HHS and DHS. These infrastructures already have operationalized safeguards for data privacy and security. And CDC will hold any received data under current protocols for data privacy and security for information obtained under 42 CFR 71.4(a) and (b).
Provisions of the Interim Final Rule
Given the limitations associated with the current regulatory requirements, CDC is exercising its statutory authority to require any airline with a flight arriving into the United States, including any intermediate stops between the flight's origin and final destination, to collect and, within 24 hours of an order by the CDC Director, transmit to CDC the following five data elements with respect to each passenger and crew member who may be at risk of exposure to a communicable disease, to the extent that such information exists for the individual, and in a format acceptable to the Director:
1. Full name;
2. Address while in the United States;
3. Email address;Start Printed Page 7877
4. Primary phone number; and
5. Secondary phone number.
These are the pieces of data most useful for CDC and provide the agency and its partners with a capability to provide critical public health services.
In order for CDC to perform its critical public health functions with respect to an outbreak of a communicable disease, the timely provision of information from the airlines is critical. But the airlines currently do not always provide such information in a timely fashion. For routine contact investigations performed during business hours without CDC surge staff, CDC experience suggests that, following a flight, it takes airlines up to seven days to respond to a single request for passenger manifest information currently collected. In addition, there is significant time and labor needed (typically several business days) for CDC to obtain additional information and process the received information into a format suitable for distribution to local health authorities in the U.S. As a result, obtaining contact information after a flight—assuming the information is available and recognizing its limitations—leads to a delay of nearly two weeks before health authorities can make the first contact. Two weeks is ample time for travelers to be lost to follow-up, or become symptomatic or infectious. The time required and costs incurred increase exponentially with multiple requests.
The required collection of this information by the airlines finds strong support in public opinion. While a significant number of air passengers expressed concerns with increased reservation or check-in time, a Harvard School of Public Health study, Project on the Public and Biological Security, found that 94% of air travelers would want public health authorities to contact them if they might have been exposed to a serious contagious disease on an airplane. In addition, 93% of domestic air travelers and 89% of international air travelers expressed a willingness to provide some type of contact information.
HHS and CDC acknowledge that coordination with other agencies reduces duplication, increases passengers' willingness to provide the information, and reduces costs to travel providers. HHS and CDC will work with all relevant departments and agencies to ensure that this process eliminates duplication with other programs and imposes the lowest cost possible on travelers and travel providers. By relying on the existing data collection and collection methods, HHS and CDC have trimmed the additional required passenger information to the minimum needed for an effective public health response. All of the data that this interim final rule requires airlines to collect and submit to CDC are data elements that the airlines are already required to submit to CDC, provided they are ordered to do so, if the data are already available and maintained. HHS and CDC also acknowledge that airlines may not currently collect all of these data and may not keep such data as they do collect in the form in which CDC would prefer to receive it. They also recognize that a certain amount of modification to airlines' information systems will be necessitated by the requirement to collect any data elements that the airlines do not currently collect from all international passengers. During this transition period, CDC anticipates working with airlines on an individual basis to ensure they are capable and able to meet the requirements of this interim final rule.
Although CDC is issuing this interim final rule, CDC continue to work with its partners to explore all avenues to obtain the information needed for a public health response to the outbreak of a communicable disease, such as 2019-nCOV.
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