2020-15810. No Sail Order and Suspension of Further Embarkation; Second Modification and Extension of No Sail Order and Other Measures Related to Operations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), a component of the U.S. Department of Health and Human Services (HHS), announces a second modification and extension of the No Sail Order and Other Measures Related to Operations that was issued on April 15, 2020. This Order applies to cruise ships defined as commercial, non-cargo, passenger-carrying vessels with the capacity to carry 250 or more individuals (passengers and crew) and with an itinerary anticipating an overnight stay onboard or a 24-hour stay onboard for either passengers or crew, that are operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States. This Order shall additionally apply to cruise ships operating outside of U.S. waters if the cruise ship operator intends for the ship to return to operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States during the period that this Order is in effect.

DATES:

This action was effective July 16, 2020.

FOR FURTHER INFORMATION CONTACT:

Jennifer Buigut, Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS V18-2, Atlanta, GA 30329. Phone: [phone]. Email: [e-mail].

SUPPLEMENTARY INFORMATION:

This Order renews the No Sail Order and Other Measures Related to Operations signed by the CDC Director on March 14, 2020, as further modified and extended effective April 15, 2020, subject to the modifications and additional stipulated conditions as set forth in this Order.

This Order shall remain in effect until the earliest of (1) the expiration of the Secretary of Health and Human Services' declaration that COVID-19 constitutes a public health emergency; (2) the CDC Director rescinds or modifies the order based on specific public health or other considerations; or (3) September 30, 2020.

A copy of the order is provided below and a copy of the signed order can be found at https://www.cdc.gov/​quarantine/​cruise/​index.html.

U.S. Department of Health and Human Services (HHS)

Centers for Disease Control and Prevention (CDC)

Order Under Sections 361 & 365 of the Public Health Service Act (42 U.S.C. 264, 268) and 42 Code of Federal Regulations Part 70 (Interstate) and Part 71 (Foreign)

Second Modification and Extension of No Sail Order and Other Measures Related to Operations

Executive Summary

The coronavirus disease 2019 (COVID-19) pandemic continues to spread rapidly around the world with no treatment or vaccine, with over 12.5 million confirmed cases and over 560,000 confirmed deaths worldwide as of July 12, 2020. On July 12, 2020, 230,000 new COVID-19 cases were reported, the largest single-day tally worldwide since the epidemic began. It took 3 months to reach the first million cases of COVID-19, but during one week in June 2020, 1 million new cases were reported worldwide.

Since HHS/CDC's original No Sail Order, signed on March 14, 2020, which restricted the embarkation of passengers, CDC has worked to control COVID-19 on cruise ships that remained at sea, while protecting against further introduction and spread of COVID-19 into U.S. communities. As of July 10, 2020, CDC has expended an estimated 38,000 person-hours on the cruise ship COVID-19 response since March 14, 2020—in addition to the thousands of hours invested by other HHS components, other U.S. government agencies, and state and local authorities. CDC continues to have regular conversations by phone and email with cruise lines, often daily.

Cumulative CDC data from the period of March 1 to July 10, 2020 reveal a total of 2,973 COVID-19 or COVID-like illness cases on cruise ships, in addition to 34 deaths. These data have also revealed a total of 99 outbreaks on 123 different cruise ships, meaning that 80% of ships within U.S. jurisdiction were affected by COVID-19 during this time frame. In addition, 9 ships still have ongoing or resolving COVID-19 outbreaks on board.

The challenges described in this document highlight the need for further action prior to cruise ships' resuming passenger operations. CDC supports the decision by the Cruise Line International Association (CLIA) and its members to voluntarily extend the suspension of operations for passenger cruise ship travel. However, because not all cruise ship operators subject to the No Sail Order are members of CLIA or have made similar commitments, CDC is extending its No Sail Order to ensure that passenger operations do not resume prematurely.

Previous Orders and Incorporation by Reference

This Order renews the No Sail Order and Other Measures Related to Operations signed by the CDC Director on March 14, 2020,^[1] as further modified and extended effective April 15, 2020 ^[2] —subject to the modifications and additional stipulated conditions as set forth in this Order.

This Order shall remain in effect until the earliest of (1) the expiration of the Secretary of Health and Human Services' declaration that COVID-19 constitutes a public health emergency; (2) the CDC Director rescinds or modifies the Order based on specific public health or other considerations; or (3) September 30, 2020.

The findings and other evidence relied upon in issuing the March 14 and April 15, 2020 Orders are incorporated herein by reference. Any ambiguity between the March 14, and April 15, 2020 Orders, as modified by the current Order, shall be resolved in favor of the current Order.

Statement of Intent

This Order shall be interpreted and implemented in a manner as to achieve the following paramount objectives:

• Preserving human life;
• Preserving the health and safety of cruise ship crew members, port personnel, and communities;
• Preventing the further introduction, transmission, and spread of COVID-19 into and throughout the United States;
• Preserving the public health and other critical resources of Federal, State, and local governments;
• Preserving hospital, healthcare, and emergency response resources within the United States; and
• Maintaining the safety of shipping and harbor conditions.

Applicability

This Modification and Extension of No Sail Order and Other Measures Related to Operations shall apply only to the subset of carriers ^[3] described below and hereinafter referred to as “cruise ships”:

All commercial, non-cargo,^[4] passenger-carrying vessels with the capacity ^[5] to carry 250 ^[6] or more individuals (passengers and crew) and with an itinerary anticipating an overnight stay onboard or a twenty-four (24) hour stay onboard for either passengers or crew that are operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States.^[7]

This Order shall additionally apply to cruise ships operating outside of U.S. waters if the cruise ship operator intends for the ship to return to operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States during the period that this Order is in effect.

Definitions

The following definitions shall apply for the purposes of this Order:

COVID-19 means the disease caused by the coronavirus SARS-CoV-2.

“Operations,” “Operate,” and “Operating” means any action by a cruise ship operator (e.g., shifting berths, moving to anchor, discharging waste, making port, or embarking or disembarking passengers or crew) to bring or cause a cruise ship to be brought into or transit in or between any international, interstate, or intrastate waterways, or maintaining a ship in layup status,^[8] subject to the jurisdiction of the United States.

“Operator” means the Master of the vessel (cruise ship) and any other crew member responsible for cruise ship operations and navigation, as well as any person or entity (including a corporate entity) that authorizes or directs the use of a cruise ship (e.g., as owner, lessee, or otherwise). A cruise ship operator may be either the cruise ship captain or the cruise line to which the cruise ship belongs, or both. The term “Operator” as used in this Order further incorporates the terms “company,” “designated person,” and “responsible person” as defined in 33 CFR § 96.120.

Events Necessitating the March 14 and April 15, 2020 Orders

On January 20, 2020, the Diamond Princess cruise ship departed Yokohama, Japan. On January 25, 2020, a symptomatic passenger departed the ship in Hong Kong, where he was later confirmed to have COVID-19. Upon the ship's return to Yokohama, Japanese authorities quarantined all passengers and crew on board the ship. Among the 3,711 Diamond Princess passengers and crew, 712 (19.2%) were subsequently confirmed to have COVID-19, 37 required intensive care, and nine died. Following this outbreak, two voyages of the Grand Princess cruise ship were ultimately associated with 159 confirmed COVID-19 cases, including eight deaths.^[9]

Because of these events, and the increased risk of transmission on cruise ships, on March 14, 2020, the CDC Director issued a No Sail Order and Other Measures Related to Operations directing cruise ships not voluntarily suspending operations to comply with certain measures. This followed a March 13, 2020, announcement by CLIA, the leading industry trade group, that its members would voluntarily suspend cruise ship operations. On March 17, 2020, CDC issued a Level 3 Travel Health Notice warning all travelers to defer cruise travel worldwide based on widespread ongoing transmission of COVID-19.^[10] Despite the announcement by CLIA, the application of the March 14, 2020 Order, and the Level 3 Travel Health Notice, cruise ships continued to be associated with COVID-19 outbreaks. Between March 14 and April 15, 2020, COVID-19 outbreaks were reported on several additional cruise ships. These included the Costa Cruises ships Costa Magica and Costa Favolosa; Holland America Line's Zaandam; the Celebrity Eclipse; the Disney Wonder; and Princess Cruises' Coral Princess.

COVID-19 outbreaks on cruise ships required 27 notifications by CDC to international, state, and local health departments for over 11,000 cruise ship passengers requiring contact tracing, which resulted in countless hours of work for numerous already-burdened public health officials. This number exceeded that of the number of contacts identified from flight investigations since the beginning of the pandemic. Medical evacuation efforts necessitated by these outbreaks required resource intensive operations that involved multiple small boats to ferry contagious crew to shore and high levels of coordination between Federal, State, and local public health, maritime, and other governmental authorities. Response efforts drew valuable resources away from the immense Federal, State, and local efforts to contain and mitigate the spread of COVID-19. State and local public health officials further stated that they faced an increasing burden supporting cruise ships attempting to make port with ill passengers or crew and struggled to repatriate passengers and crew while also protecting the limited medical assets available to their communities. The intensive care requirements for infected passengers and crew in need of life-saving critical care also greatly stressed an already overtaxed healthcare system that at the time was facing shortages of masks, test kits, beds, and ventilators needed to respond to COVID-19.

Accordingly, to protect public health and safety and prevent the further introduction, transmission, and spread of COVID-19 into and throughout the United States, the CDC Director issued an Order modifying and extending the previous March 14, 2020 Order, which became effective on April 15, 2020.

Events Since the Issuance of the April 15, 2020 Extension

Under the April 15, 2020 Extension, as a condition of obtaining controlled free pratique to continue to engage in cruise ship operations in any international, interstate, or intrastate waterways subject to the jurisdiction of the United States, cruise ship operations were limited, and cruise lines were required to submit plans to prevent, mitigate, and respond to the spread of COVID-19 on board to ensure a safe work environment and disembarkation for crew members. The No Sail Order (NSO) response plans had to minimize to the greatest extent possible any impact on U.S. government operations or the operations of any State or local government, or the U.S. healthcare system. While working with cruise ship operators to ensure the completeness and accuracy of these response plans, CDC allowed crew members to disembark from cruise ships in U.S. waters and return home if cruise ship operators attested to complying with requirements to disembark crew members in such a manner as to minimize the risk to other travelers and communities. Among other requirements, safe disembarkation meant not using commercial transport for disembarking crew, screening disembarking crew members for illness, ensuring that crew members with known exposure to COVID-19 traveled separately from those with no known exposure, providing face masks or cloth face coverings to disembarking crew members or confirming that they had their own face coverings, and instructing disembarking crew members to stay home for 14 days and continue to practice social distancing after reaching their final destination. This disembarkation process proved cumbersome and labor intensive; it is still ongoing even now with over 14,000 crew remaining onboard, due in part to limited charter flight availability, cruise lines' cost burdens, and some destination countries' refusing to accept returning crew.

Following the April 15, 2020 Extension, CDC published its Interim Guidance for Mitigation of COVID-19 Among Cruise Ship Crew During the Period of the No Sail Order to assist cruise ship operators in preventing, detecting, and medically managing confirmed and suspected SARS-CoV-2 infections and exposures among crew members.^[11] During this period, CDC also further assisted cruise ship operators with humanitarian medical evacuations for people in need of lifesaving support. As of July 10, 2020, CDC has worked with cruise ship operators to assist in the disembarkation and safe return home of approximately 8,825 crew members, including 314 U.S. citizens and residents.

Under the April 15, 2020 Extension, CDC established an enhanced surveillance process to provide a more complete picture of COVID-19 activity on cruise ships. CDC required weekly submission of the “Enhanced Data Collection (EDC) During COVID-19 Pandemic Form.” The EDC form was used to conduct surveillance for COVID-19 among crew who remained on board cruise ships based on cumulative reports of acute respiratory illness (ARI),^[12] influenza-like illness (ILI),^[13] pneumonia, and other clinical indicators. As of July 10, 2020, EDC reports have shown a total of 4,590 polymerase chain reaction (PCR) tests performed, 281 (6%) of which were positive, 18 hospitalizations, 2 instances of mechanical ventilation, and 9 medical evacuations for crew on ships within U.S. jurisdiction since April 15, 2020. CDC recommended that ships' surveillance include routine testing for SARS-CoV-2 infection, including intermittent testing of a random sample of symptomatic and asymptomatic crew members.

In addition to reviewing the NSO response plans, CDC continued to update its Interim Guidance as new information became available; provided technical expertise to ships with ongoing outbreaks; created cruise ship-specific websites to inform crew members, the public, and partners; and reviewed hundreds of attestations for safe disembarkation and transfer of crew members.

CDC also established a “COVID-19 Color Coding System” for ships applicable to cruise ship operators with an appropriate NSO response plan for crew management. Classification of ships under this system requires cruise company officials to sign an acknowledgment of the completeness and accuracy of their NSO response plans upon completion of CDC review of the plan. CDC additionally provides a provisional color status for ships belonging to cruise lines that do not yet have a complete and accurate plan. CDC assesses the status of a ship by reviewing surveillance data from the weekly EDC form.

• “Green” ship status means that a ship has no confirmed cases of COVID-19 or COVID-like illness for 28 ^[14] consecutive days among crew members onboard. In addition, cruise ship operators must sign an attestation that if the ship received ship-to-ship transfers, the crew members came from a ship with no cases of COVID-19 or COVID-like illness within the 28 days before the transfer occurred and that land-based crew embarking the ship were immediately quarantined for 14 days. Ships achieving “Green” status may use commercial travel to disembark crew members and may lessen onboard restrictions to allow crew to resume some daily interactions with fellow crew members, including social gatherings, group meetings, and use of group settings such as crew bars and gyms.

• “Yellow” ship status means that a previously designated “Green” ship reported one or more COVID-like illness cases onboard and that testing for COVID-19 is pending. If crew with COVID-like illness are not tested by PCR or if results are not available within 1 week of the case being reported, then the ship's status changes to “Red.” Ships with a “Yellow” status are required to resume all preventive measures, with the exception of requiring crew members to remain in cabins as much as possible during non-working hours, and are no longer eligible for commercial travel of disembarking crew.
• “Red” ship status means that one or more cases of laboratory-confirmed COVID-19 or COVID-like illness have occurred onboard within the past 28 days, that ship-to-ship transfers occurred from a ship that was not “Green,” that embarking crew were not immediately quarantined for 14 days, or that the ship failed to submit one or more weekly EDC forms during the past 28 days. Ships with a “Red” status must follow all preventive measures, including requiring crew members to remain in cabins as much as possible during non-working hours, until the ship's status changes to “Green.”

The status of the cruise ship operator NSO response plans and the color-coding status for individual ships are updated weekly at https://www.cdc.gov/​coronavirus/​2019-ncov/​travelers/​crew-disembarkations-commercial-travel.html.

Difficulty of Cruise Ship Operators in Submitting Appropriate Response Plans

As of April 29, 2020, CDC had received NSO response plans from seven cruise ship operators representing approximately 110 cruise ships or about 95% of cruise ships subject to the April 15, 2020 Extension. These operators included Carnival Corporation,^[15] Royal Caribbean Cruise Line, Norwegian Cruise Lines, Disney Cruise Lines, Virgin Voyages, Windstar Cruises,^[16] and Bahamas Paradise Cruise Lines. MSC Cruises submitted an NSO response plan on May 7, 2020, covering three of its ships.

In order to manage the public health crisis occurring at sea, including analyzing epidemiologic data, reviewing and responding to NSO response plan submissions, and managing the safe disembarkation of crew, CDC created a Maritime Unit (MU) staffed with 30 subject matter experts. The MU developed an email box staffed 7 days a week to handle the volume of cruise-related inquires received by CDC during the pandemic and established daily communications with cruise lines. For the plan review process, two MU team members were assigned to review each plan and communicate with the submitting cruise line. The work-intensive plan review process has involved assessing hundreds of documents from each cruise line to determine if they completely and adequately addressed the elements of an appropriate plan described in the April 15, 2020 Extension. Most plans needed two complete reviews and revisions, with one plan requiring seven rounds of revisions.

The plans as initially submitted by the cruise lines were incomplete and did not fully meet all the requirements of the April 15, 2020 Extension. Areas of major concern included insufficient details for monitoring crew onboard; unspecified quantities of personal protective equipment, medical and laboratory supplies, and fever-reducing medications; incomplete plans to disembark asymptomatic crew safely; missing shoreside and onboard testing agreements, supplies, and protocols; not isolating symptomatic crew; failing to close self-service buffets, salons, gyms, and recreational water facilities; lack of ability to provide the required level of medical care; and implementing social distancing and other restrictions only when physically present in U.S. waters. CDC has provided feedback to assist cruise lines in determining how best to address these concerns.

By July 10, 2020, cruise ship operators had reduced the number of cruise ships they proposed to operate in U.S. waters to approximately 49 ships, with some operators choosing to temporarily withdraw all ships remaining in U.S. waters. As of July 10, 2020, one cruise ship operator representing only one cruise ship operating in U.S. waters had an NSO response plan meeting all the elements described in the April 15, 2020 Extension: Bahamas Paradise Cruise Line.

Examples of Potential Non-Compliance With the Extended No Sail Order

The difficulty of cruise ship operators in submitting appropriate NSO response plans was compounded by several instances of potential non-compliance with the requirements of the April 15, 2020 Extension. On April 29, 2020, CDC sent a Notice of Potential Non-Compliance with the No Sail Order to Holland America Line in response to attempts by a crew member to disembark from the Oosterdam without cruise line officials' attesting that precautions to protect public health had been taken. This attempted disembarkation without appropriate precautions required CDC, U.S. Coast Guard, U.S. Customs and Border Protection, California Department of Public Health, Los Angeles County Health Department, and Los Angeles Police Department to leverage valuable resources and work together to enforce the NSO. In response, Holland America Line stated that the incident was the result of confusion between Oosterdam administrative personnel and local port agents. As a corrective measure, Holland America Line spoke to the local agents at the Port of Los Angeles and instructed them not to approve further disembarkations unless specifically instructed by shoreside management.

On May 11, 2020, CDC sent a “Dear Colleague” letter to cruise ship operators. The letter stated that CDC was aware of allegations of cruise ship non-compliance with the April 15, 2020 Extension through social media and other sources. Alleged instances of non-compliance included not adhering to social distancing protocols; unauthorized crew transfers while outside of U.S. waters; not submitting weekly surveillance data (through the EDC form); not relocating all crew to single-occupancy cabins with private bathrooms; not cancelling all social gatherings; and not closing all crew bars, gyms, or other group settings. The letter requested that cruise ship operators investigate and report instances of non-compliance to CDC and explain in writing what corrective actions had been taken to ensure future compliance. Only two cruise ship operators, Virgin Voyages ^[17] and Royal Caribbean Cruise Ltd (RCL), and CLIA ^[18] responded in writing.

On May 13, 2020, RCL responded to the May 11 “Dear Colleague” letter stating that it had investigated the allegations in the six areas described in the letter and believed that it was in full compliance. On June 9, 2020, CDC sent a letter to RCL stating that on May 20, 2020, CDC had received attestations for 64 ship-to-ship transfers occurring from May 12 to May 20 for 21 ships in both the Royal Caribbean International and Celebrity Cruises, Inc. brands. While RCL had originally represented that these transfers were for crew who met CDC's criteria for “recovered” from COVID-19, RCL in later communications acknowledged that transferred crew had not met these criteria. Furthermore, while RCL officials did submit multiple attestations for these transfers, the attestations were submitted belatedly after the transfers were complete. The submitted attestations were also per ship, not per disembarkation, and lacked a required disembarkation date. For these reasons, the attestations were inconsistent with CDC's Interim Guidance. On June 15, 2020, RCL responded stating that these incidents were due to a misinterpretation of the Interim Guidance and that it would adjust its practices in the future.

On May 22, 2020, CDC sent a Notice of Potential Non-Compliance with the No Sail Order to Norwegian Cruise Line Holdings Ltd (NCLH). The notice stated that CDC had become aware of reports of alleged non-compliance on several NCLH cruise ships including the Norwegian Escape, Norwegian Epic, Norwegian Joy, Oceania Marina, and Seven Seas Navigator. These allegations included not adhering to social distancing protocols, not cancelling all social gatherings, not relocating all crew to single-occupancy cabins with private bathrooms, not suspending self-service buffets, and crew not wearing cloth face coverings when outside individual cabins. CDC further requested that NCLH address the veracity of these allegations and outline what corrective steps it would take to prevent reoccurrences.

On May 29, 2020, NCLH sent a response to CDC's May 22 letter. It cited the difficulty in achieving and mandating social distancing among crew members at all times. NCLH had modified dining venues, seating, and meal service to facilitate social distancing, but allowed a “maximum of 4 persons at a table” onboard all ships. It had also “designated large open-air area spaces to be utilized by crew at their leisure, limiting the amount of people and encouraging social distancing.” NCLH stated that ships operating with reduced manning limited its ability to operate without self-service buffets. Lastly, NCLH stated that it believed it had exceeded CDC's guidance “by not just asking but encouraging our crew to wear face coverings.” NCLH's response did not specifically address what corrective actions it would take to align its practices with CDC's Interim Guidance and did not address the issue of not relocating crew to single-occupancy cabins with private bathrooms.

On July 2, 2020, CDC sent NCLH an additional notice requesting that it take immediate corrective action to align its practices with the April 15, 2020 Extension and CDC's Interim Guidance. CDC asked NCLH to explain with greater specificity what steps it had taken to instruct crew across its fleet to wear cloth face coverings when outside of individual cabins (e.g., through posted signage or verbal reminders). CDC further noted that depending on table size, allowing a maximum of 4 persons at a table did not ensure maintaining a minimum distance of 2 meters (6 feet) from one another during meal service. Furthermore, to the extent that NCLH had allowed crew to gather in any group setting, it was advised to discontinue this practice until “Green” status onboard the ship had been achieved. Moreover, CDC advised NCLH that operating a self-service meal operation was considered a high-risk practice because of the role of fomites in transmission of COVID-19 and advised it to discontinue this practice on all ships across its fleet. Lastly, CDC requested NCLH explain whether it had at any time not relocated all crew to single-occupancy cabins with private bathrooms.

On July 9, 2020, CDC received NCLH's response to its July 2 letter. NCLH stated that it had implemented new procedures to mandate the wearing of face coverings by crew members when outside of individual cabins. To reinforce this mandate, it had instituted “mask patrols” comprised of security team members who were authorized to order crew members back to their cabins if seen not properly masked in public areas. NCLH also confirmed that it had discontinued its previous practice of allowing up to four crewmembers to dine together at the same table. It further confirmed that it understood CDC's color-coding system and noted that all gyms, bars, and lounges fleetwide were closed and remained closed since the inception of the NSO. NCLH had also disseminated CDC materials in written form fleetwide to all crew members, instead of conducting in person meetings or trainings on COVID-19. NCLH further confirmed that it had discontinued self-service meal operations and in lieu of such self-service operations had designated crew members to assist other crew members during meal service. Lastly, while it had initially found housing of all crew members in single-occupancy cabins to be infeasible based on the number of crew members on board, it confirmed that all remaining crew members who had not repatriated were currently housed in single occupancy cabins with private bathrooms.

On June 10, 2020, CDC sent a Notice of Potential Non-Compliance with the No Sail Order to Disney Cruise Lines (DCL) relating to inadequate spacing and mixing of staterooms intended for “well” and “sick” crew and potential failure to discontinue buffet meal service during an ongoing COVID-19 outbreak. These concerns were based on records and photographs received by CDC from the Disney Wonder to document compliance with elements outlined in the April 15, 2020 Extension. CDC also sent DCL a separate letter documenting its concerns regarding a sustained outbreak of COVID-19 or COVID-like illness among crew onboard the Disney Wonder during the period of the April 15, 2020 Extension. Since April 15, 2020, CDC had received reports of 181 cases of confirmed COVID-19 and 19 case of COVID-like illness associated with this ship. Of particular concern was the fact that this outbreak had continued over a ten-week time frame, including before the April 15, 2020 Extension, with the last date of COVID-like illness reported to CDC on May 25, 2020.

On June 24, 2020, DCL responded that inadequate spacing and mixing of staterooms intended for “well” and “sick” crew occurred because of the challenges of transferring asymptomatic, symptomatic, and COVID-19-positive crew members between rooms and limited availability of vacant staterooms with balconies. DCL also denied that an “active” buffet meal service was in place and affirmed that crew members would point out desired meal items and then have other crew members serve those items to them on a plate. In regard to the outbreak onboard the Disney Wonder, DCL asserted that any discrepancies in reporting positive test results to the CDC were due to inadvertent error. As a corrective action, DCL stated that it had reviewed and reinforced the proper procedures for reporting of illness to the CDC. In describing what factors may have led to the magnitude and duration of this outbreak, DCL noted that numerous crew members who subsequently tested positive for COVID-19 were asymptomatic and that some of these crew members served as essential crew and were not quarantined in their rooms until the results of ship-wide testing were received.

Actions Taken by Other Countries in Regard to Cruise Ship Travel

A number of countries have taken aggressive steps to mitigate the risks of COVID-19 exacerbated by cruise ship travel. On March 9, 2020, Canada's Chief Public Health Officer issued a formal health advisory asking all Canadians to avoid travelling on cruise ships because the ships represent a high-risk environment for viral transmission of COVID-19. On March 19, 2020, the Canadian Government issued Ship Safety Bulletin No. 05/2020: Deferral of the Canadian Cruise Ship Season for Vessels Capable of Carrying 500 Persons or More until July 1, 2020.^[19] These regulations restricted cruise ships capable of carrying 500 or more persons, including both passengers and crew members from accessing ports managed by port authorities, public ports, public port facilities, and the St. Lawrence Seaway until July 1, 2020. On May 29, 2020, these restrictions were extended to cruise ships with overnight accommodations carrying more than 100 people operating in Canadian waters until October 31, 2020.

On March 18, 2020, the Governor-General of the Commonwealth of Australia declared a human biosecurity emergency that included a ban on international cruise ships entering Australian ports.^[20] On May 15, 2020, the Governor-General extended the human biosecurity emergency period for an additional three months, from June 17 to September 17, 2020.^[21] This enabled the Minister for Health on May 20, 2020, to extend a prohibition on the arrival at any Australian port of any international cruise ship that had left a foreign port. These restrictions include direct arrivals and round-trip cruises. On May 22, 2020, the restriction on cruise ships entering Australian waters was extended for a further three months until September 17, 2020. Under this restriction, any cruise ship capable of carrying more than 100 passengers is prohibited from operating cruises in Australia. When this restriction went into effect on March 27, 2020, there were 28 international cruise ships in Australian waters. Under the direction of the Australian Border Force, these ships and their crew safely departed.

In addition, as of July 10, 2020, numerous countries have restricted passenger cruise ship travel to some degree. These include Aruba, Barbados, Bermuda, British Virgin Islands, Cayman Islands, Dominican Republic, Greece, Grenada, Honduras, Norway, Panama, Seychelles, and Spain.

Supplemental Information Relating to COVID-19 Transmission Onboard Cruise Ships

As of July 10, 2020, CDC has recorded approximately 99 outbreaks of COVID-19 onboard 123 ships within U.S. jurisdiction ^[22] including 958 confirmed cases, 2,015 suspect/probable cases and 34 deaths. Of the 49 ships currently operating or planning to operate in U.S. waters during the period of the April 15, 2020 Extension, COVID-19 activity onboard continues and there still remain 10 “Provisionally Red” ships (i.e., reporting at least one confirmed case of COVID-19 or COVID-like illness in the past 28 days).

Since the issuance of the April 15, 2020 Extension, cruise ships with significant outbreaks involving passengers and crew, such as the Celebrity Eclipse (92 confirmed COVID-19 cases, 8 suspect/probable COVID-19-like illness cases) and the Coral Princess (29 confirmed, 107 suspect/probable, and 5 deaths), arrived on U.S. shores as other countries around the world closed their ports to cruise ships.^[23] These outbreaks not only endangered those onboard and at seaports, but also exposed travelers and communities throughout the world as sick and exposed passengers from ships like the Zandaam ^[24] (10 confirmed, 233 suspect/probable, 7 deaths), Ruby Princess, and Costa Luminosa traversed international airports, boarded planes, and returned to their homes. The CDC does not have official case counts for the Costa Luminosa and Ruby Princess, which docked in foreign seaports; however, the media have reported that these two ships are responsible for a significant number of cases and deaths.¹⁴ These outbreaks have continued in crew members on ships like the Disney Wonder, on which a COVID-19 outbreak spanned 10 weeks and included 229 confirmed and 43 COVID-like illness cases among crew.

The current scientific evidence suggests that cruise ships pose a greater risk of COVID-19 transmission than other settings. A recent article published in the Journal of Travel Medicine by Rocklöv et al. demonstrated that the Diamond Princess cruise ship experienced an onboard R₀ (basic reproduction rate) for COVID-19 of 14.8 before ship-wide quarantine was enacted.^[25] This means that each case onboard the Diamond Princess transmitted COVID-19 to approximately 15 other people. This reproduction rate is approximately four times higher than the R₀ of the original epicenter of the outbreak in Wuhan, China, which was 3.7, meaning that each person with COVID-19 in the early days of the outbreak in Wuhan transmitted the disease to approximately four other people. In late February/early March, 149 cases of PCR-confirmed COVID-19 (of 589 tour participants) were found among U.S. residents linked to Egyptian Nile Cruises. This heightened rate of transmission onboard cruise ships has been documented in other academic publications.^9 [26] Cruise ship conditions amplified an already highly transmissible disease.

Rocklöv et al. surmised that this heightened rate of transmission is due to the high population density onboard on ships, which are typically more densely populated than cities or most other living situations. While this is one contributing factor, CDC's surveillance data acquired during the period of the NSO show that drastically decreasing population onboard does not extinguish transmission. Other factors likely contributing to onboard transmission are crew living and working in close quarters in a partially enclosed environment where social distancing may prove challenging even with a limited number of people onboard.

In addition, the recent investigation by Payne et al. of transmission onboard a U.S. Navy ship demonstrated high transmission rates and high rates of mild disease and asymptomatic infection among crew.²⁵ These mild presentations and asymptomatic cases make case detection and isolation and quarantine practices based on clinical presentation alone challenging. Thus, covert spread of infection among crew may keep the virus circulating from one voyage to the next. The Navy ship investigation also demonstrates the importance of avoiding onboard congregate settings. However, with limited dining options and work areas on board cruise ships, avoiding congregate settings is challenging for crew.

Numerous challenges have arisen in detecting COVID-19 transmission onboard ships. Although examples can be given from most cruise lines, the experiences of four Royal Caribbean ships, the Vision of the Seas, Liberty of the Seas, Enchantment of the Seas, and Adventure of the Seas, particularly illustrate how an undetected COVID-19 outbreak may occur. These four ships reported no confirmed COVID-19 cases or COVID-like illness in crew for 28 days or longer. However, when crew subsequently disembarked in countries that required shoreside testing, confirmed cases of COVID-19 were detected in 55 crew members. While CDC has recommended periodic random testing of symptomatic and asymptomatic crew, to our knowledge, only 20 of 49 ships currently operating or planning to operate in U.S. waters during the period of the April 15, 2020 Extension have performed testing.

While regular testing is not a panacea and a negative test result cannot be used to rule out infection conclusively,^[27] the addition of viral testing can help detect infected crew members earlier and isolate them from others. Viral testing should be used along with other measures to decrease transmission,^[28] such as symptom screening, isolation and quarantine, routine social distancing, and frequent handwashing. Unfortunately, testing requires a rapid turnaround of results to be useful, and this has proven particularly challenging for ships, even when in port. Difficulties may include lack of point-of-care testing onboard and inadequate staffing to collect, track and transport samples. When rapid testing is more available, regular, repeated testing of those on board, as recommended in other high-density workplace settings, may help to detect COVID-19 outbreaks. Absent wider availability and implementation of testing, undetected outbreaks of COVID-19 among crew are likely to reoccur.

Lack of Consensus Among Cruise Ship Operators and Need for Additional Industry-Led Efforts Regarding Safely Resuming Passenger Operations

Cruise ship operators have taken tentative steps to advance their public health response to COVID-19, improve safety, and achieve readiness to safely resume passenger operations. Under the co-chairmanship of former Health and Human Services Secretary Michael O. Leavitt, two cruise lines, RCL and NCLH, have assembled a team of subject-matter experts from a variety of disciplines under the moniker of the “Healthy to Sail Alliance.” The group intends “over the next few months . . . to conduct a robust, scientifically grounded exploration on issues of cruise line health and safety” (emphasis added). Furthermore, this group states that it will “deliver to the cruise lines a set of public health recommendations that will provide participating cruise lines with a guide or pathway as they pursue their individual company efforts to achieve the confidence of regulators and passengers.”

Additionally, a variety of cruise lines have promoted interventions to manage COVID-19 onboard ships in both online and in print marketing materials. These interventions include enhanced stateroom cleaning, installation of new air filters, preboarding health screenings, increased social distancing, increased availability of hand sanitizer, and more self-service meal options. It would thus be of benefit to have further industry-led engagement as to which strategies, best practices, and procedures, either singularly or in combination, would be most effective in protecting the health of passengers, crew, and global communities.

CDC will continue to update its guidance and recommendations to specify basic safety standards and public health interventions based on the best scientific evidence available. CDC will also continue to consult with international maritime public health partners on ways to reduce COVID-19 transmission on ships and will continue to monitor the global COVID-19 situation.

Findings and Immediate Action

The difficulty to date of cruise ship operators to submit and adhere to appropriate NSO response plans during a time of limited operations, as well as ongoing concerns relating to non-compliance with disease prevention protocols and continued outbreaks of COVID-19 onboard cruise ships, highlight the need for further action prior to resuming passenger operations.

Accordingly, and consistent with 42 CFR 70.2, 71.31(b), and 71.32(b), the Director of CDC (“Director”) finds that cruise ship travel exacerbates the global spread of COVID-19, that the scope of this pandemic is inherently and necessarily a problem that is international and interstate in nature, and such transmission has not been controlled sufficiently by the cruise ship industry or individual State or local health authorities. As described in the March 14, 2020 Order, cruise ship travel markedly increases the risk and impact of the COVID-19 disease epidemic within the United States. If unrestricted cruise ship passenger operations were permitted to resume, infected and exposed persons disembarking cruise ships would place federal partners (e.g., Customs and Border Protection and the U.S. Coast Guard), healthcare workers, port personnel, and communities at substantial unnecessary risk.

The Director also finds evidence to support a reasonable belief that cruise ships are or may be infected or contaminated with a quarantinable communicable disease.^[29] This reasonable belief is based on information from epidemiologic and other data included in this document and the information described in the March 14, 2020 Order and the April 15, 2020 Extension. As a result, persons on board or seeking to board cruise ships may likely be or would likely become infected with or exposed to COVID-19 by virtue of being on board at a time when cases of COVID-19 are being reported in increasingly significant numbers globally.^[30]

Accordingly, under 42 CFR 70.2, the Director determines that measures taken by State and local health authorities regarding COVID-19 onboard cruise ships are inadequate to prevent the further interstate spread of the disease.

This Order is not a rule within the meaning of the Administrative Procedure Act (“APA”), but rather an emergency action taken under the existing authority of 42 CFR 70.2, 71.31(b), and 71.32(b). In the event that this Order qualifies as a rule under the APA, notice and comment and a delay in effective date are not required because there is good cause to dispense with prior public notice and the opportunity to comment on this Order.^[31] Considering the public health emergency caused by COVID-19 based, among other things, on its potential for spread on board cruise ships, it would be impracticable and contrary to the public health, and by extension the public interest, to delay the issuance and effective date of this Order. Similarly, if this Order qualifies as a rule per the definition in the APA, the Office of Information and Regulatory Affairs has determined that it would be a major rule, but there would not be a delay in its effective date as the agency has invoked the good cause provision of the APA.

If any provision in this Order, or the application of any provision to any carriers, persons, or circumstances, shall be held invalid, the remainder of the provisions, or the application of such provisions to any carriers, persons, or circumstances other than those to which it is held invalid, shall remain valid and in effect.

In accordance with 42 U.S.C. 264(e), this Order shall supersede any provision under State law (including regulations and provisions established by political subdivisions of States), that conflict with an exercise of Federal authority, including instructions by U.S. Coast Guard or HHS/CDC personnel permitting ships to make port or disembark persons under stipulated conditions, under this Order.

This Order shall be enforceable through the provisions of 18 U.S.C. 3559, 3571; 42 U.S.C. 243, 268, 271; and 42 CFR 70.18, 71.2.

Therefore, in accordance with Sections 361 and 365 of the Public Health Service Act (42 U.S.C. 264, 268) and 42 CFR 70.2, 71.31(b), 71.32(b), for all cruise ships described above for the period described below, it is ordered:

Measures Related To Protecting Public Health of Communities Signed on March 14, 2020

These measures were implemented to provide public health authorities, in concert with the cruise ship industry, the necessary pause in operations to develop and implement an appropriate and robust plan (1) to prevent and mitigate the further spread of COVID-19 in communities, and (2) to prevent the spread of the disease onboard and ensure the health of cruise ship passenger and crew.

Accordingly, the following terms and conditions of the No Sail Order and Other Measures Related to Operations signed on March 14, 2020, as modified and extended by this order, shall remain in effect. Consequently, it remains ordered:

1. Cruise ship operators shall not disembark or reembark crew members except as directed by the USCG, in consultation with HHS/CDC personnel and, as appropriate, as coordinated with Federal, State, and local authorities.

2. Cruise ship operators shall not embark any new passengers or crew, except as approved by USCG, or other Federal authorities as appropriate, in consultation with HHS/CDC personnel.

3. While in port, the cruise ship operator shall observe health precautions as directed by HHS/CDC personnel.

4. The cruise ship operator shall comply with all HHS/CDC, USCG, and other Federal agency instructions to follow CDC recommendations and guidance for any public health actions relating to passengers, crew, ship, or any article or thing on board the ship, as needed, including by making ships' manifests and logs available and collecting any specimens for COVID-19 testing.

Measures Related To Protecting Public Health and Crew Safety Signed on April 9, 2020 and Made Effective on April 15, 2020

These measures were implemented to, among other things, ensure a safe environment for crew members to work and disembark by requiring the submission of appropriate NSO response plans by cruise ship operators as a condition of obtaining controlled free pratique ^[32] to continue to engage in any cruise ship operations in any international, interstate, or intrastate waterways subject to the jurisdiction of the United States.

Accordingly, the terms and conditions of the Modification and Extension of No Sail Order and Other Measures Related to Operations, intended to protect public health and crew safety, signed on April 9, 2020, and made effective on April 15, 2020, as modified and extended by this order, shall remain in effect. Consequently, it remains ordered:

1. As a condition of obtaining controlled free pratique to continue to engage in any cruise ship operations in any international, interstate, or intrastate waterways subject to the jurisdiction of the United States, cruise ship operators shall develop, implement, and operationalize, an appropriate, actionable, and robust plan to prevent, mitigate, and respond to the spread of COVID-19 among crew onboard cruise ships.

2. As a condition of obtaining controlled free pratique to continue to engage in any cruise ship operations in any international, interstate, or intrastate waterways subject to the jurisdiction of the United States, the cruise ship operator shall make the plan described in paragraph 1, above, available to HHS/CDC and USCG personnel.

3. An appropriate plan is one that adequately prevents, mitigates, and responds to the spread of COVID-19 among crew onboard cruise ships and that, at a minimum, addresses the following elements:

a. Onboard surveillance of crew with acute respiratory illnesses, influenza-like illnesses, pneumonia, and COVID-19, including reporting to HHS/CDC on a weekly basis on overall case counts, methods of testing, and number of crew requiring hospitalization or medical evacuation;

b. Reports on the number of crew onboard the cruise ship and any increase in the numbers of crew with COVID-19 made to HHS/CDC and USCG on a daily basis for as long as the cruise ship is within waters subject to the jurisdiction of the United States;

c. Onboard monitoring of crew through temperature checks and medical screening, including addressing frequency of monitoring and screening;

d. Training of all crew on COVID-19 prevention, mitigation, and response activities;

e. Protocols for any COVID-19 testing, including details relating to the shore-side transport, administration, and operationalization of laboratory work if onboard laboratory work is not feasible;

f. Onboard isolation, quarantine, and social distancing protocols to minimize the risk of transmission and spread of COVID-19;

g. Onboard medical staffing, including number and type of staff, and equipment in sufficient quantity to provide a hospital level of care (e.g., ventilators, facemasks, personal protective equipment) for the infected so as to minimize the need for hospitalization onshore;

h. An outbreak management and response plan to provision and assist an affected cruise ship that relies on industry resources, e.g., mobilization of additional cruise ships or other vessels to act as “hospital” ship for the infected, “quarantine” ship for the exposed, and “residential” ship for those providing care and treatment, including the ability to transport individuals between ships as needed;

i. Categorization of affected crew into risk categories with clear stepwise approaches for care and management of each category;

j. A medical care plan addressing onboard care versus evacuation to on-shore hospitals for critically ill crew, specifying how availability of beds for critically ill at local hospitals will be determined in advance and how the cruise ship operator will ensure acceptance at local medical facilities to treat the critically ill in a manner that limits the burden on Federal, State, and local resources and avoids, to the greatest extent possible, medivac situations. If medical evacuation is necessary arrangements for evacuation must be made with commercial resources (e.g., ship tender, chartered standby vessel, chartered airlift) and arrangements made with a designated medical facility that has agreed to accept such evacuees. All medical evacuation plans must be coordinated with the U.S. Coast Guard;

k. Detailed logistical planning for evacuating and repatriating both U.S. citizens and foreign nationals to their respective communities and home countries via foreign government or industry-chartered private transport and flights, including the steps the cruise ship operator will take to ensure those involved in the transport are not exposed (i.e., without the use of commercial flights to evacuate or repatriate individuals, whether within or from the United States);

l. The projected logistical and resource impact on State and local government and public health authorities and steps taken to minimize the impact and engage with these authorities; all plans must provide for industry/cruise line management of suspected or confirmed cases of COVID-19 without resource burden on Federal, State, or local governments;

m. Plan execution in all U.S. geographical areas—all plans must be capable of being executed anywhere in international, interstate, or intrastate waterways subject to the jurisdiction of the United States; and

n. Cleaning and disinfection protocols for affected cruise ships.

4. An appropriate plan shall be designed to minimize, to the greatest extent possible, any impact on U.S. government operations or the operations of any State or local government, or the U.S. healthcare system.

5. The cruise ship operator shall further ensure that the plan is consistent with the most current CDC recommendations and guidance for any public health actions related to COVID-19. Where appropriate, a cruise ship operator may coordinate the development, implementation, and operationalization of a plan with other cruise ship operators, including an industry trade group.

Measures Related to Continued Protection of Public Health and Crew Safety

These measures are intended to continue to protect U.S. communities, ensure a safe environment for crew to work and disembark, and defer the embarkation of passengers until there is a clear pathway for a safe return to passenger operations.

Accordingly, it is ordered:

1. Cruise ship operators shall continue to suspend passenger operations and not embark passengers, except as approved by HHS/CDC personnel and USCG, in consultation with other federal authorities as appropriate.

2. As a condition of obtaining or retaining controlled free pratique to operate in any international, interstate, or intrastate waterways subject to the jurisdiction of the United States, cruise ship operators shall continue to follow CDC's Interim Guidance for Mitigation of COVID-19 Among Cruise Ship Crew During the Period of the No Sail Order, including reporting to HHS/CDC through weekly submission of the Enhanced Data Collection (EDC) form, as may be updated.^[33] Additionally, cruise ship operators shall report to USCG via Advance Notice of Vessel Arrival (ANOA), whenever in U.S. waters.

3. As a condition of obtaining or retaining controlled free pratique to operate in any international, interstate, or intrastate waterways subject to the jurisdiction of the United States, cruise ship operators with appropriate NSO response plans shall continue to follow the COVID-19 Color Coding System requiring preventive measures for crew onboard based on the ship's status, as determined by HHS/CDC.

4. As a condition of obtaining or retaining controlled free pratique to operate in any international, interstate, or intrastate waterways subject to the jurisdiction of the United States, cruise ship operators with appropriate NSO response plans shall conduct viral testing for COVID-19 for crew in such a manner as described in the relevant CDC guidance with reporting of results on the EDC form.

5. As a condition of obtaining or retaining controlled free pratique to operate in any international, interstate, or intrastate waterways subject to the jurisdiction of the United States, cruise ship operators must observe the requirements of this Order, the previous Orders, and the most current CDC recommendations and guidance for any public health actions related to COVID-19, even when outside of U.S. waters for any ships that intend to return to U.S. waters during the period that this Order remains in effect.

This Order is effective upon signature and shall remain in effect until the earliest of (1) the expiration of the Secretary of Health and Human Services' declaration that COVID-19 constitutes a public health emergency; (2) the CDC Director rescinds or modifies the order based on specific public health or other considerations; or (3) September 30, 2020.

Authority

The authority for these orders is Sections 361 and 365 of the Public Health Service Act (42 U.S.C. 264, 268) and 42 CFR 70.2, 71.31(b), 71.32(b).

Note: Elsewhere in this issue of the Federal Register, CDC is publishing a companion notice that requests information from the public regarding cruise ship planning and infrastructure, safe resumption of passenger operations, and summary questions.

Dated: July 16, 2020.

Robert K. McGowan,

Chief of Staff, Centers for Disease Control and Prevention.

Footnotes

1.  No Sail Order and Suspension of Further Embarkation. www.federalregister.gov/​documents/​2020/​03/​24/​2020-06166/​no-sail-order-and-suspension-of-further-embarkation. Last accessed June 24, 2020.

2.  No Sail Order and Suspension of Further Embarkation; Notice of Modification and Extension and Other Measures Related to Operations. www.federalregister.gov/​documents/​2020/​04/​15/​2020-07930/​no-sail-order-and-suspension-of-further-embarkation-notice-of-modification-and-extension-and-other. Last accessed June 24, 2020.

3.  Carrier is defined by 42 CFR 71.1 to mean, “a ship, aircraft, train, road vehicle, or other means of transport, including military.”

4.  Given the substantial risk of person-to-person transmission of COVID-19, as opposed to transmission via indirect contact, this Order is currently limited to passenger, non-cargo vessels.

5.  A ship's capacity shall be determined based on the number of persons listed in the U.S. Coast Guard Certificate of Inspection issued in accordance with 46 CFR 2.01-5 and that was in effect on the date of the signing of this current Order.

6.  Based on substantial epidemiologic evidence related to congregate settings and mass gatherings, this Order suspends operation of vessels with the capacity to carry 250 individuals or more. Evidence shows that settings as small as nursing homes or movie theaters can proliferate the spread of a communicable disease. As the numbers of passengers and crew on board a ship increase, certain recommended mitigation efforts such as social distancing become more difficult to implement. In light of the demonstrated rapid spread of COVID-19 in cruise ship settings, application of this Order to vessels carrying 250 or more individuals is a prudent and warranted public health measure. Moreover, during the early part of 2020, management of COVID-19 cases in addition to care needs resulting from the seasonal influenza epidemic placed an extreme burden on public health and healthcare systems and this Order will help avoid further stressing those systems.

7.  This order shall not apply to vessels operated by a U.S. Federal or State government agency. Nor shall it apply to vessels being operated solely for purposes of the provision of essential services, such as the provision of medical care, emergency response, activities related to public health and welfare, or government services, such as food, water, and electricity.

8.  Layup means reducing cruise ship operations to those levels needed to maintain essential machinery and equipment so that the ship may be returned to service.

9.  Moriarty LF, Plucinski MM, Marston BJ, et al. Public Health Responses to COVID-19 Outbreaks on Cruise Ships—Worldwide, February-March 2020. MMWR Morb Mortal Wkly Rep 2020;69:347-352. https://www.cdc.gov/​mmwr/​volumes/​69/​wr/​mm6912e3.htm. Last accessed June 25, 2020.

10.  CDC Travel Health Notice, COVID-19 and Cruise Ship Travel, at: https://wwwnc.cdc.gov/​travel/​notices/​warning/​coronavirus-cruise-ship (originally posted, March 17, 2020). Last accessed June 25, 2020.

11.  CDC, Interim Guidance for Mitigation of COVID-19 Among Cruise Ship Crew During the Period of the No Sail Order at: https://www.cdc.gov/​quarantine/​cruise/​management/​interim-guidance-no-sail-order.html

12.  Acute Respiratory Illness (ARI) is defined as the presence of cough, sore throat, or rhinorrhea in the absence of fever.

13.  Influenza-like Illness (ILI) is defined as fever (100.4 °F [38 °C]) plus either cough or sore throat in the absence of another diagnosis.

14.  The 28-day period for COVID-19 is based on the public health standard of 2 incubation periods, which is commonly used to determine that a communicable disease of public health concern is no longer circulating in a location.

15.  On May 24 and again on June 3, 2020, Carnival Corporation communicated to CDC that none of its operating companies had any ships in U.S. waters, nor did they expect to have any ships returning to U.S. waters before the end of the NSO period. Accordingly, CDC has held its review of the Carnival response plan in abeyance.

16.  While Windstar Cruises initially submitted an NSO response plan for one of its ships, it later withdrew its ships from U.S. waters and stated it had no intention of returning those ships to U.S. waters during the period of the NSO. Accordingly, CDC has held its review of the Windstar response plan in abeyance.

17.  On May 13, 2020, Virgin Voyages submitted a report listing non-conformities with the NSO. As a corrective measure, it added its NSO response plan in its entirety to its company Safety Management System and further advised its ships that any proposed deviations required advance approval.

18.  On May 14, 2020, CLIA responded to the letter requesting a meeting with the CDC Director to further engage with CDC. Subsequently, on June 11, the CDC Director hosted a teleconference with CLIA and other members of the cruise line industry during which CDC responded to questions submitted by CLIA relating to procedures, clarifications, and crew transfers and repatriations under the NSO.

19.  Deferral of the Canadian Cruise Ship Season for Vessels Capable of Carrying 500 Persons or More until July 1, 2020—SSB No.: 05/2020. www.tc.gc.ca/​eng/​marinesafety/​bulletins-2020-05-eng.htm. Last accessed June 24, 2020.

20.  COVID-19 Legislative response—Human Biosecurity Emergency Declaration Explainer. www.aph.gov.au/​About_​Parliament/​Parliamentary_​Departments/​Parliamentary_​Library/​FlagPost/​2020/​March/​COVID-19_​Biosecurity_​Emergency_​Declaration. Last accessed June 24, 2020.

21.  Cruise Ship Prohibition Extended. www.newsroom.abf.gov.au/​releases/​cruise-ship-prohibition-extended. Last accessed June 24, 2020.

22.  The U.S. Coast Guard considers certain ships operating outside of U.S. waters subject to their jurisdiction for emergency response purposes. These ships are not included in CDC's calculations.

23.  The Pandemic at Sea. www.washingtonpost.com/​graphics/​2020/​politics/​cruise-ships-coronavirus/​. Last accessed June 18, 2020.

24.  The Pariah Ship. www.bloomberg.com/​features/​2020-zaandam-pariah-ship/​. Last accessed June 18, 2020.

25.  Rocklöv J, Sjödin H, Wilder-Smith A. COVID-19 Outbreak on the Diamond Princess Cruise Ship: Estimating the Epidemic Potential and Effectiveness of Public Health Countermeasures. J. Travel Med. 2020; 18;27(3):taaa030. doi: 10.1093/jtm/taaa030.

26.  Payne DC, Smith-Jeffcoat SE, Nowak G, et al. SARS-CoV-2 Infections and Serologic Responses from a Sample of U.S. Navy Service Members — USS Theodore Roosevelt, April 2020. MMWR Morb Mortal Wkly Rep 2020;69:714-721. DOI: http://dx.doi.org/​10.15585/​mmwr.mm6923e4.

27.  Watson J, Whiting PF, Brush JE. Interpreting a covid-19 test result. BMJ 2020; 369: m1808. doi: https://doi.org/​10.1136/​bmj.m1808.

28.  Testing Strategy for Coronavirus (COVID-19) in High-Density Critical Infrastructure Workplaces after a COVID-19 Case Is Identified. www.cdc.gov/​coronavirus/​2019-ncov/​community/​worker-safety-support/​hd-testing.html. Last accessed June 18, 2020.

29.  COVID-19 is a communicable disease for which quarantine is authorized under section 361 of the Public Health Service Act (42 U.S.C. 264) and 42 CFR 70.1, 71.1, as listed in Executive Order 13295, as amended by Executive Orders 13375 and 13674.

30.  Since the March 14, 2020 Order, the number of global cases of COVID-19 reported by the World Health Organization (WHO) has risen from 142,534 to 12,102,328 as of July 10, 2020, with 551,046 deaths. See Situation Reports, WHO, https://www.who.int/​emergencies/​diseases/​novel-coronavirus-2019/​situation-reports.

31.  See 5 U.S.C. 553(b)(B), (d)(3).

32.  Under 42 CFR 71.1, controlled free pratique means permission for a carrier to enter a U.S. port, disembark, and begin operation under certain stipulated conditions.

33.  For cruise ship operators with ships that have not been in U.S. waters during the period of the No Sail Order or voluntarily withdrew their ships, the following conditions must be met prior to a ship returning to U.S. waters: (1) Submission of the EDC form for 28-days preceding expected arrival in U.S. waters, and (2) a complete and accurate NSO response plan, including a signed Acknowledgment of No Sail Order Response Plan Completeness and Accuracy.