[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59720-59733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23573]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Temporary Extension and Modification of Framework for Conditional
Sailing Order (CSO) for Cruise Ships Operating or Intending To Operate
in U.S. Waters
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), a
component of the Department of Health and Human Services (HHS),
announces a temporary extension and modification of the Framework for
Conditional Sailing Order (CSO).
DATES: This action is effective November 1, 2021, at 12:01 a.m. EDT
upon the expiration of the current Order.
FOR FURTHER INFORMATION CONTACT: Jennifer Buigut, Division of Global
Migration and Quarantine, Centers for Disease Control and Prevention,
1600 Clifton Road NE, MS H16-4, Atlanta, GA 30329. Phone: 404-498-1600.
Email: [email protected].
SUPPLEMENTARY INFORMATION: This Order temporarily extends and modifies
the Framework for Conditional Sailing Order (CSO). This Order only
applies to cruise ship operators in U.S. jurisdictions where foreign-
flagged ships port or travel on international itineraries and state and
local health departments do not routinely exercise public health
jurisdiction nor maintain maritime public health programs that conduct
surveillance, inspections, investigations, and management for
communicable diseases with potential for significant morbidity and
mortality onboard foreign-flagged ships. These specific jurisdictions
are listed below in the Order.
This Order additionally applies to foreign-flagged 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.
As per the Preliminary Injunction Order, entered by the U.S.
District Court for the Middle District of Florida on June 18, 2021, as
of July 23, 2021, the CSO and accompanying measures, such as technical
instructions, are nonbinding recommendations for cruise ships arriving
in, located within, or departing from a port in Florida. Accordingly,
this Order shall not apply to this subset of ships while this
Preliminary Injunction Order remains in effect (or in the event the
Preliminary Injunction becomes permanent). However, CDC will continue
to operate the CSO as a voluntary program for such ships should they
choose to follow the CSO measures on a voluntary basis.
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)
Temporary Extension & Modification of Framework for Conditional Sailing
Order (CSO)
Executive Summary
The Centers for Disease Control and Prevention is temporarily
extending the Framework for Conditional Sailing Order (CSO) issued on
October 30, 2020. Since the issuance of the CSO, cruise lines, with CDC
assistance, have resumed passenger operations and successfully
developed and implemented health and safety protocols to manage COVID-
19 that have averted overwhelming onboard medical facilities and
burdening shoreside hospital resources. However, considering the
continued spread of the Delta variant, emergence of other COVID-19
variants of concern, breakthrough cases among the fully vaccinated, and
possible additional surges of cases and deaths, CDC has determined a
temporary extension of the CSO is necessary for foreign-flagged cruise
ships operating on international itineraries. After the expiration of
this temporary extension, CDC intends to transition to a voluntary
program, in coordination with interested cruise ship operators and
other stakeholders, to assist the cruise ship industry to detect,
mitigate, and control the spread of COVID-19 onboard cruise ships.
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) January 15, 2022 at 12:01 a.m. (EST).
Previous Orders and Incorporation by Reference
The findings and other evidence relied upon in issuing the CSO are
incorporated herein by reference. Any ambiguity between the October 30,
2020 Order, as further modified and extended by the current Order,
shall be resolved in favor of the current Order.
Applicability
This temporary renewal and modification of the CSO shall apply only
to the subset of carriers \1\ described below and hereinafter referred
to as ``cruise ships'':
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\1\ Carrier is defined by 42 CFR 71.1 to mean, ``a ship,
aircraft, train, road vehicle, or other means of transport,
including military.''
All commercial, non-cargo,\2\ foreign-flagged,\3\ passenger-
carrying vessels operating
[[Page 59721]]
in U.S. waters with the capacity \4\ to carry 250 \5\ 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.\6\
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\2\ 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.
\3\ This Order modifies the CSO so that it is applicable only to
foreign-flagged vessels that per 46 U.S.C. 55103 may not travel
between U.S. ports without including a stop at a foreign port in
their itinerary. Because foreign-flagged vessels typically operate
on international itineraries far from U.S. shores, outbreaks on such
vessels are more likely to require emergency medical evacuations
while at sea and thus burden U.S. Coast Guard and other emergency
medical response resources. Furthermore, stopping in a foreign port
increases the risk of introducing a COVID-19 variant of concern into
the United States. [International Travel During COVID-19 [verbarlm]
CDC].
\4\ A ship's capacity shall be determined based on the number of
persons listed in the U.S. Coast Guard Certificate of Compliance
issued in accordance with 46 CFR 2.01-6 and that was in effect on
October 30, 2020.
\5\ CDC continues to define cruise ships as those with a
capacity to carry 250 or more passengers and crew based on
substantial epidemiologic evidence related to congregate settings
and mass gatherings. While evidence shows that outbreaks can occur
in small settings such as nursing homes, 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. Considering the demonstrated rapid spread of COVID-19,
the application of this framework to cruise ships carrying 250 or
more passengers and crew remains prudent and warranted.
\6\ 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.
This Order shall additionally apply to foreign-flagged 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.
As explained further in this Order, based on the CDC Director's
determination of inadequate local control under 42 CFR 70.2,\7\ this
Order shall only apply to cruise ship operators in U.S. jurisdictions
where foreign-flagged ships port or travel on international itineraries
and state and local health departments do not routinely exercise public
health jurisdiction nor maintain maritime public health programs that
conduct surveillance, inspections, investigations, and management for
communicable diseases with potential for significant morbidity and
mortality \8\ onboard foreign-flagged ships.\9\
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\7\ Because this Order applies only to foreign-flagged vessels
that per 46 U.S.C. 55103 may not travel between U.S. ports without
including a stop at a foreign port in their itinerary, 42 CFR
71.31(b), 71.32(b), constitute sufficient legal authority to support
this Order. However, 42 CFR 70.2 provides additional legal authority
and support to the extent that it is needed for the reasons
explained in this Order.
\8\ In addition to quarantinable communicable diseases as
defined under 42 CFR 70.1 and 71.1, communicable diseases with
potential for significant morbidity and mortality include diseases
that spread from person to person, such as respiratory diseases
(e.g., varicella, mumps, pertussis, meningococcal disease) and
norovirus, and those that arise from contaminated food, potable
water, or recreational water (e.g., Salmonella, Escherichia coli,
Cryptosporidium), or the environment, such as Legionnaires' disease.
\9\ These jurisdictions include the following U.S. states:
Alabama, Alaska, California, Delaware, Florida, Georgia, Hawaii,
Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan,
Minnesota, Mississippi, New Hampshire, New Jersey, New York, North
Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina,
Texas, Virginia, and Washington State. These jurisdictions also
include the following U.S. territories: American Samoa, Guam,
Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands.
CDC is not currently aware of any states or U.S. territories
operating a maritime public health program that would displace the
CSO.
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As per the Preliminary Injunction Order, entered by the U.S.
District Court for the Middle District of Florida on June 18, 2021, as
of July 23, 2021, the CSO and accompanying measures, such as technical
instructions, are nonbinding recommendations for cruise ships arriving
in, located within, or departing from a port in Florida. Accordingly,
this Order shall not apply to this subset of ships while this
Preliminary Injunction Order remains in effect (or in the event the
Preliminary Injunction becomes permanent). However, CDC will continue
to operate the CSO as a voluntary program for such ships should they
choose to follow the CSO measures on a voluntary basis.
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.
Summary of CSO Extension Compared to Previous CSO
This temporary extension of the CSO leaves major provisions of the
previous CSO unchanged with only minor modifications to incorporate
changes in technical instructions made based on discussions and
feedback from cruise ship operators and announced through ``Dear
Colleague'' communications to industry partners. Accordingly, CDC does
not view this temporary extension as imposing any new burdens or
obligations on cruise ship operators when compared to the previous CSO.
As further explained in this extension, the most significant change is
to narrow the applicability of the CSO to ``foreign-flagged'' cruise
ships operating in U.S. jurisdictions that do not routinely exercise
public health jurisdiction nor maintain maritime public health programs
that conduct surveillance, inspections, investigations, and management
for communicable diseases with potential for significant morbidity and
mortality onboard foreign-flagged ships.
Currently, there is only one cruise ship operator under the CSO
that is not foreign-flagged and operates its ships exclusively in
interstate waterways subject to the jurisdiction of the United States.
Unlike ocean-going foreign-flagged vessels, in the event of an
outbreak, interstate vessels typically operate in such a manner that,
should an outbreak occur, passengers and crew can be quickly brought by
ambulance to local hospitals without requiring airlifts or evacuations
at sea that significantly burden U.S. Coast Guard or potentially
overwhelm public health resources.\10\ Interstate vessels also operate
under the jurisdiction of the Food and Drug Administration's (FDA)
Interstate Travel Program and are subject to additional federal
oversight under the provisions of 21 CFR 1240, 1250. Accordingly, CDC
believes that narrowing the application of the CSO in this manner does
not jeopardize the public's health. Furthermore, should this cruise
ship operator choose to do so, it may continue to follow the CSO on a
voluntary basis.
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\10\ Another cruise ship operator has one U.S.-flagged cruise
ship that operates solely between Hawaiian Islands. Similar to
interstate vessels, the ship can quickly make port and bring
passengers and crew by ambulance to local hospitals without
requiring airlifts or evacuations at sea that significantly burden
U.S. Coast Guard or potentially overwhelm public health resources.
While foreign-flagged cruise ships operating on the Great Lakes may,
depending on their itineraries, be able to return to port more
quickly than ocean-going vessels, based on their international
itineraries they would not fall under FDA's Interstate Travel
Program. Furthermore, as discussed elsewhere, state and local health
departments are engaged in other COVID-19 response efforts.
Accordingly, excluding foreign-flagged vessels operating
international itineraries on the Great Lakes from the application of
this Order would create a regulatory gap.
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CDC provides the following chart to further explain how key
substantive
[[Page 59722]]
provisions of this temporary extension operate compared to the previous
CSO:
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CSO sections Modifications
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Acronyms, Initialisms, and Definitions. Definition of cruise
ships narrowed by adding
``foreign-flagged''.
Purpose and Scope...................... Unchanged.
General Prohibition on a Cruise Ship Unchanged.
Operator Commencing or Continuing
Passenger Operations without a COVID-
19 Conditional Sailing Certificate.
Requirements for COVID-19 Response Plan Previously referred to
for Cruise Ship Operators Operating or as ``No Sail Order (NSO)
Intending to Operate Cruise Ships in Response Plans''.
U.S. Waters. No changes for
operators with previously
approved plans.
Requirements for COVID-19 Testing No new requirements:
Capabilities and Reporting for Cruise cruise ship operators
Ship Operators Operating or Intending completed requirements as part
to Operate Cruise Ships in U.S. Waters. of previous CSO ``Phase 1''
crew testing.
Modified to
incorporate current Technical
Instructions for Crew.
Agreement with Port and Local Health Modified to
Authorities. incorporate current Port
Agreement Technical
Instructions.
Minimum Standards for Simulated Voyages Removed language
Prior to Issuance of COVID-19 referring to cruise ship
Conditional Sailing Certificate. operator protocols as
``unproven and untested''.
Modified to
incorporate current Technical
Instructions for Simulated
Voyages.
Procedures in Lieu of Conducting a New provision aimed at
Simulated Voyage for Cruise Ship reducing potential industry
Operators Transitioning to Voyages burden for certain operators.
with Less Than 95% of Passengers Fully Based on ``Dear Cruise
Vaccinated. Industry Colleagues'' email
sent on September 21, 2021.
Webpage updates pending.
Modified Simulated Voyage Requirements New provision aimed at
in Lieu of a Full Simulated Voyage for reducing potential industry
Cruise Ship Operators Repositioning to burden for certain operators.
U.S. Waters and Intending to Operate Based on ``Dear Cruise
with Less than 95% of Passengers Fully Industry Colleagues'' email
Vaccinated. sent on September 21, 2021.
Webpage updates pending.
Applying for a COVID-19 Conditional Shortened CDC's time
Sailing Certificate. to respond to an application
from 60 days to 5 days based
on ``Dear Cruise Industry
Colleagues'' letter of April
28, 2021.
Removed requirement
for an attestation under 18
U.S.C. 1001 in line with
intent to operate future
program on a voluntary basis.
Removed requirement to
submit a copy of the USCG
Certificate of Inspection.
Review of an Application for a COVID-19 Removed requirement to
Conditional Sailing Certificate. submit proof of inspection by
any other agency.
Amendment or Modification of COVID-19 Unchanged.
Conditional Sailing Certificate
Unchanged from original CSO.
Minimum Standards for Restricted Removed requirement to
Passenger Voyages as a Condition of include any CDC travel
Obtaining and Retaining a COVID-19 advisory, warning, or
Conditional Sailing Certificate. recommendation relating to
cruise travel in marketing
material.
Removed requirement to
limit voyage to 7 days.
Removed requirement
for monitored observation
period of passengers prior to
embarking.
Minimum Standards for Management of Modified to state that
Passengers and Crew from COVID-19- voyage may be ended and
affected Cruise Ships for Restricted further action taken if a ship
Passenger Voyages. meets ``red ship criteria''
under Technical Instructions
for Crew.
Removed previous
requirement that cruise ship
operator must immediately end
voyage, cancel future voyages,
and return to port if COVID-19
identified onboard.
Denials, Suspension, Revocation, and Unchanged.
Reinstatement of a Cruise Ship
Operator's COVID-19 Conditional
Sailing Certificate.
Administrative review.................. Unchanged.
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Acronyms, Initialisms, and Definitions
(a): The acronyms and initialisms below will have the following
meaning:
ARI means Acute Respiratory Illness defined as the presence of
cough, sore throat, or runny nose (rhinorrhea) in the absence of fever
and in the absence of a non-infectious diagnosis (e.g., allergies) as
determined by the ship's medical provider, or as defined by CDC in
technical instructions.
CLI means COVID-19-like Illness.
CDC means U.S. Department of Health and Human Services, Centers for
Disease Control and Prevention, or an authorized representative acting
on its behalf.
EDC means Enhanced Data Collection.
ILI means influenza-like illness defined as fever (>=100.4 [deg]F
[38 [deg]C]) plus either cough or sore throat or as defined by CDC in
technical instructions.
(b): The terms below will have the following meaning:
Controlled Free Pratique has the same meaning as under 42 CFR 71.1.
COVID-19 means the disease caused by the coronavirus SARS-CoV-2.
COVID-19-like Illness means ARI, ILI, pneumonia, or other signs or
symptoms of COVID-like illness as defined by CDC in technical
instructions.
Crew or Crew member means any individual serving on board a cruise
ship who is assigned to perform regular duties or tasks on behalf of a
cruise ship operator in exchange for compensation.
Cruise ship means any commercial, non-cargo, foreign-flagged,
passenger-carrying vessel operating in U.S. waters with the capacity to
carry 250 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.
Cruise ship 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
[[Page 59723]]
corporate entity) that authorizes or directs the use of a cruise ship
(e.g., as owner, lessee, or otherwise). A cruise ship operator may also
include the cruise ship captain or the cruise line to which the cruise
ship belongs, and the officers and directors of the cruise line.
Director means the Director of the Centers for Disease Control and
Prevention, U.S. Department of Health and Human Services, or an
authorized representative.
Isolation means measures taken by a cruise ship operator to ensure
the onboard or onshore separation of passengers or crew displaying
signs or symptoms of COVID-19, or who have tested positive for SARS-
CoV-2, from other passengers or crew who do not display such signs or
symptoms or have not tested positive for SARS-CoV-2.
Laboratory Testing or Laboratory Test Results means testing
performed in a laboratory certified as meeting the standards of the
Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 U.S.C.
263a) and 42 CFR 493 or CLIA-waived point-of-care testing or the
results of such testing. Testing must be performed using tests that are
approved, cleared, or authorized for emergency use by the U.S. Food and
Drug Administration (FDA) as specified by CDC in technical instructions
or orders.
Operate or Operating in U.S. waters means any action by a cruise
ship operator to bring or cause a cruise ship to be brought into or
transit in or between any waterways (e.g., shifting berths, moving to
anchor, discharging waste, making port, or embarking or disembarking
passengers or crew) subject to the jurisdiction of the United States.
Passenger means any individual being transported or offered
transport on board a cruise ship who is not a crew member, excluding
U.S. government personnel.
Passenger operations means any action by a cruise ship operator to
cause passengers to embark or disembark a cruise ship.
Person means any individual or partnership, firm, company,
corporation, association, organization, or other legal entity.
Physical distancing means maintaining a distance of at least 6
feet, or such other distance as specified by CDC in technical
instructions, between one individual and another individual, not
gathering in groups, and avoiding crowded places and mass gatherings.
Quarantine means measures taken by a cruise ship operator to ensure
the onboard or onshore separation and restriction of movement of
passengers or crew who were potentially exposed to a person with COVID-
19 while that person was considered infectious.
Responsible officials mean the Chief Executive Officer (or
equivalent) of the operating cruise company and all parent companies,
the Chief Compliance Officer (or equivalent) of the operating cruise
company and all parent companies, and the highest-ranking Medical
Officer of the operating cruise company and all parent companies.
Simulated voyage means a trial voyage designed and implemented in
so far as possible to replicate real world onboard conditions of
cruising with measures in place to mitigate the risk of COVID-19.
U.S. waters means any international, interstate, or intrastate
waterways that are subject to the jurisdiction of the United States.
Background
Successful Resumption of Passenger Operations in Collaboration With
Cruise Industry Partners
While cruising will never be a zero-risk activity for spread of
COVID-19, CDC has successfully worked with cruise ship operators to
manage this risk and allow cruise ship operators to resume passenger
operations in a way that mitigates the risk to crew members,
passengers, port personnel, and communities. On October 30, 2020, CDC
issued the CSO, which resumes cruise ship passenger operations in U.S.
waters through a phased approach. There are four phases to the CSO:
Mass crew testing and acquiring onboard laboratory testing
equipment (Phase 1),
Preparing for simulated and revenue voyages (e.g.,
identifying locations through port agreements to provide for the
quarantine or isolation, respectively, of exposed and ill passengers)
(Phase 2A) and simulated voyages to test onboard health and safety
protocols (Phase 2B),
Applying for a COVID-19 Conditional Sailing Certificate
(Phase 3); and
Restricted passenger revenue voyages with public health
precautions (Phase 4).
Cruise ship operators that choose to sail with 95% vaccinated crew
and 95% vaccinated passengers do not have to conduct a simulated voyage
prior to applying for a COVID-19 Conditional Sailing Certificate.
Cruise ships that have been operating restricted passenger voyages with
95% vaccinated crew and 95% vaccinated passengers may also transition
to voyages with less than 95% vaccinated passengers by conducting
modified simulated voyage procedures in lieu of a full simulated
voyage. Similarly, cruise ships that have been conducting passenger
operations in non-U.S. jurisdictions and intend to operate in U.S.
waters with less than 95% vaccinated passengers after repositioning to
the U.S. may apply for a COVID-19 Conditional Sailing Certificate after
conducting modified simulated voyage procedures instead of a full
simulated voyage.
As of October 21, 2021, out of the 83 ships covered by the CSO, all
have acquired the onboard laboratory testing equipment required by the
CSO.\11\ As of October 21, 2021, cruise ship operators representing 16
brands--American Queen Steamboat Company, Bahamas Paradise Cruise Line,
Carnival Cruise Line, Celebrity Cruises, Crystal Cruises, Disney Cruise
Line, Holland America Line, MSC Cruises, Norwegian Cruise Line, Oceania
Cruises, Princess Cruises, Regent Seven Seas Cruises, Royal Caribbean
International, Silversea Cruises, Ltd, Viking Cruises, and Virgin
Voyages--have submitted port agreements to CDC's Maritime Unit.
Additionally, CDC's Maritime Unit has been in discussions with cruise
ship operators representing 2 additional brands--Azamara and
ResidenSea--with specific plans to operate ships under the CSO. These
port agreements collectively cover 17 primary ports of call: Cape
Liberty Cruise Port (New Jersey), Port of Baltimore, Port of Boston,
Port Canaveral, Port Everglades, Port of Galveston, Port of Long Beach,
Port of Los Angeles, Port of Miami, Port of New Orleans, Port of New
York (Manhattan), Port of Palm Beach, Port of San Diego, Port of San
Francisco, Port of San Juan, Port of Seattle, and Port Tampa Bay.\12\
\13\ CDC's Maritime Unit has approved port agreements for all 83
vessels covered by the CSO. Forty-eight vessels have been approved for
more than one port.
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\11\ The CSO does not require cruise ships to build onboard
laboratories. Rather, cruise ship operators must procure an onboard
testing unit about the size of a desktop printer that easily fits
within their existing medical centers. This equipment allows cruise
ship operators to more easily test for the virus that causes COVID-
19, can be operated with rudimentary training, and does not require
a professional laboratorian. Moreover, cruise ships' pre-existing
medical centers typically already have different types of laboratory
testing equipment on board for diagnosing illness.
\12\ This list represents primary ports of call (i.e., home
ports) and does not include secondary ports of call, such as those
in Alaska.
\13\ Primary ports of call approved for American Queen Steamboat
Company are not included in this list because their ships are U.S.-
flagged and do not travel internationally. Therefore, their ships
will no longer be covered under the definition of ``cruise ship'' in
the temporary extension of the CSO.
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[[Page 59724]]
As of October 21, 2021, CDC's Maritime Unit has received and
granted 18 requests from cruise ship operators to conduct simulated
voyages under the CSO. As of October 21, 2021, CDC Maritime Unit
inspectors have conducted 16 onboard inspections and investigations of
15 ships, including a second inspection on a ship that transitioned
from a simulated voyage to a restricted passenger voyage. These
inspections ranged from one-day inspections while the ship was in port,
to inspections that lasted several days while the ship was underway.
Because cruise ship operators are restarting operations mostly on ships
that have not carried passengers in U.S. waters since March 2020, and
with new crew implementing new health and safety protocols, there may
be shortfalls in training or in fully implementing protocols. However,
cruise ship operators have worked closely with CDC Maritime Unit
inspectors to identify and quickly remedy any observed lapses in
training or protocols.
Since the issuance of the CSO in October 2020, CDC has worked
collaboratively with cruise lines to ensure a safer restart of
passenger operations. As of October 21, 2021, CDC's Maritime Unit has
received and granted COVID-19 Conditional Sailing Certificates to
conduct revenue passenger voyages to 53 ships operating under the CSO.
During numerous regularly scheduled discussions, cruise industry
representatives have expressed their desire to rebuild passenger
confidence and prove COVID-19 can be successfully managed on board
cruise ships sailing in U.S. waters. Despite the best efforts of cruise
ship operators to provide a safer and healthier environment for crew
and passengers, public health concerns relating to the ongoing
pandemic, emergence of variants of concerns such as the Delta variant,
and breakthrough infections in fully vaccinated persons highlight the
need to temporarily extend the CSO, particularly as we see high levels
of transmission in the United States and globally, including in
countries with high rates of vaccination, such as the United Kingdom
and Israel.\14\ \15\
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\14\ https://covid19.who.int/region/euro/country/gb.
\15\ https://covid19.who.int/region/euro/country/il..
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Current State of COVID-19 Pandemic
As of October 21, 2021, there have been almost 241 million cases of
COVID-19 globally, resulting in over 4,900,000 deaths.\16\ Over 45
million cases have been identified in the United States, with new cases
reported daily, and over 730,000 deaths attributed to the disease.\17\
Forecasting teams predict numbers of deaths, hospitalizations, and
cases using different types of data (e.g., COVID-19 data, demographic
data, mobility data), methods, and estimates of the impacts of
interventions (e.g., physical distancing, use of face masks). A renewed
surge in cases in the United States began in early July 2021; case
counts rose from 19,000 cases per day on July 1, 2021 to over 150,000
cases per day on August 31, 2021. During the pandemic, cases have
tended to surge in waves with 4 waves as of October 2021.\18\
Therefore, additional surges of cases and deaths could be expected to
occur. Similar to seasonal epidemics of influenza and other respiratory
viruses, surges in cases, hospitalizations, and deaths from COVID-19
could also be expected to occur in winter as more people spend time
indoors due to inclement weather.
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\16\ https://covid19.who.int/.
\17\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
\18\ https://www.cdc.gov/coronavirus/2019-ncov/science/forecasting/mathematical-modeling.html.
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The virus that causes COVID-19 spreads very easily and sustainably
between people, particularly those who are in close contact with one
another (within about 6 feet, but occasionally over longer distances).
COVID-19 spreads when an infected person breathes out droplets and very
small particles that contain the virus. These droplets and particles
can be breathed in by other people or land on their eyes, noses, or
mouth. Individuals without symptoms can also spread the virus. Among
adults, the risk for severe illness from COVID-19 increases with age,
with older adults at highest risk. Severe illness means that persons
with COVID-19 may require hospitalization, intensive care, or a
ventilator to help them breathe, and may be fatal. People of any age
with certain underlying medical conditions (e.g., cancer, obesity,
serious heart conditions, diabetes) are at increased risk for severe
illness from COVID-19.\19\
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\19\ https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html.
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Emergence of Variants
Variants of SARS-CoV-2, the virus that causes COVID-19, are
expected to continue to emerge. Some will emerge and disappear, and
others will emerge and continue to spread and may replace previous
variants.\20\ While it is known and expected that viruses constantly
change through mutation leading to the emergence of new variants, the
Delta variant is particularly concerning because it causes more
infections and spreads faster than earlier forms of SARS-CoV-2.\21\ It
has rapidly become the predominant strain in the United States,
estimated to account for 99.7% of U.S. cases \22\ and has been reported
in 193 places \23\ worldwide as of October 20, 2021.
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\20\ https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html#Concern.
\21\ Li B, Deng A, Li K, et al. Viral Infection and Transmission
in a Large Well-Traced Outbreak Caused by the Delta SARS-CoV-2
Variant. medRxiv. 2021 Jul 12; https://doi.org/10.1101/2021.07.07.21260122.
\22\ https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
\23\ https://covid.cdc.gov/covid-data-tracker/#global-variant-report-map.
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Recent studies have also demonstrated that some fully vaccinated
people exposed to the Delta variant can become infected, and those
persons can be contagious and spread the illness to others, although
their infectious period appears to be shorter compared to people who
are not fully vaccinated.\24\ \25\ \26\ Delta has been shown to result
in higher viral loads in infected people, and spreads twice as easily
from one person to another, compared to earlier strains. The ultimate
concern is the emergence of a ``variant of high consequence'' that
undermines existing public health defenses by substantially decreasing
the effectiveness of available testing, treatments, and vaccines
against severe or deadly disease.\27\ While such a variant of high
consequence has not yet been identified, so long as new variants of
SARS-CoV-2 continue to emerge and circulate, the potential for such a
variant to arise remains a possibility.
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\24\ Brown CM, Vostok J, Johnson H, et al. Outbreak of SARS-CoV-
2 Infections, Including COVID-19 Vaccine Breakthrough Infections,
Associated with Large Public Gatherings--Barnstable County,
Massachusetts, July 2021. MMWR Morb Mortal Wkly Rep 2021;70:1059-
1062. DOI: http://dx.doi.org/10.15585/mmwr.mm7031e2.
\25\ Dougherty K, Mannell M, Naqvi O, Matson D, Stone J. SARS-
CoV-2 B.1.617.2 (Delta) Variant COVID-19 Outbreak Associated with a
Gymnastics Facility--Oklahoma, April-May 2021. MMWR Morb Mortal Wkly
Rep 2021;70:1004-1007. DOI: http://dx.doi.org/10.15585/mmwr.mm7028e2.
\26\ CDC: Delta Variant: What We Know about the Science.
\27\ SARS-CoV-2 Variant Classifications and Definitions, Centers
for Disease Control and Prevention, https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html#Concern (last updated September
23, 2021).
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Availability of Vaccines and Delta Variant
COVID-19 vaccines are now widely available in the United States,
and vaccination is currently recommended for all people 12 years of age
and older. As of October 21, 2021, over 189 million people in the
United States (66.9% of
[[Page 59725]]
the population 12 years or older) have been fully vaccinated and over
219 million people in the United States (77.4% of the population 12
years or older) have received at least one dose.\28\
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\28\ https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total.
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The three COVID-19 vaccines approved or authorized in the United
States are highly effective at preventing severe disease and death from
COVID-19, including against the Delta variant.\29\ \30\ But some fully
vaccinated people will still become infected (breakthrough infection)
and experience illness. While vaccination has shown to lower the risk
of severe COVID-19 cases or death, people who are vaccinated and become
infected with the Delta variant may still transmit the virus to others,
although vaccinated people appear to be infectious for a shorter
period.\31\ \32\ \33\ \34\ This evidence coupled with people getting
vaccinated at a slower rate in the United States, and the extreme
transmissibility of the Delta variant has resulted in rapidly rising
numbers of COVID-19 cases, primarily and disproportionately affecting
those not fully vaccinated.
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\29\ Bernal JL, Andrews N, Gower C, et al. Effectiveness of
Covid-19 Vaccines against the B.1.617.2 (Delta) Variant. N Engl J
Med. 2021 Jul 21;doi:10.1056/NEJMoa2108891external icon.
\30\ Thompson MG, Burgess JL, Naleway AL, Tyner H, Yoon SK,
Meece J, et al. Prevention and Attenuation of Covid-19 with the
BNT162b2 and mRNA-1273 Vaccines. N Engl J Med. 2021;385(4):320-9.
\31\ Mlcochova P, Kemp S, Dhar S, et al. SARS-CoV-2 B.1.617.2
Delta Variant Emergence and Vaccine Breakthrough. Research Square
Platform LLC. 2021 Jun 22; doi:10.21203/rs.3.rs-637724/v1external
icon.
\32\ Musser JM, Christensen PA, Olsen RJ. et al. Delta Variants
of SARS-CoV-2 Cause Significantly Increased Vaccine Breakthrough
COVID-19 Cases in Houston, Texas. medRxiv. 2021 Jul 22; https://org/
10.1101/2021.07.07.21260122.
\33\ Brown CM, Vostok J, Johnson H, et al. Outbreak of SARS-CoV-
2 Infections, Including COVID-19 Vaccine Breakthrough Infections,
Associated with Large Public Gatherings--Barnstable County,
Massachusetts, July 2021. MMWR Morb Mortal Wkly Rep. ePub: 30 July
2021; https://www.cdc.gov/mmwr/volumes/70/wr/mm7031e2.htm.
\34\ Chia PY, Ong SWX, Chiew CJ, et al. Virological and
serological kinetics of SARS-CoV-2 Delta variant vaccine-
breakthrough infections: a multi-center cohort study.
2021;doi:doi.org/10.1101/2021.07.28.21261295.
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Justification for Temporary Extension of CSO
Despite the best efforts of cruise ship operators to provide a
safer and healthier environment for crew and passengers, including
operating ships with high percentages of vaccinated persons onboard,
outbreaks of COVID-19 have continued to occur, many involving
breakthrough infections in fully vaccinated persons. Between June 7-30,
2021, a cruise ship operator identified 21 laboratory-confirmed COVID-
19 cases onboard one of its ships, with the majority of cases among
fully vaccinated persons. CDC's Maritime Unit assisted the cruise ship
operator with the investigation to prevent further spread of the virus
on board. In addition, the Maritime Unit collaborated with CDC's COVID-
19 Laboratory Task Force to have specimens from this outbreak
genetically sequenced to identify if a variant of concern was the
cause. Results showed that the outbreak was in fact, due to the highly
transmissible Delta variant.
As cruise ship operators continue to embark new crew in
anticipation of more passenger revenue voyages in the U.S., cases of
COVID-19 among crew have been reported, highlighting the continued need
for public health management of cases to mitigate this risk. The
resumption of passenger voyages in the U.S. has led to the introduction
and sustained transmission of COVID-19 among cruise ships, despite high
vaccination rates among both crew and passengers. With an increase in
traveler volume, cruise ships have experienced increased numbers of
COVID-19 cases among passengers and crew. Between June 26-October 21,
2021, 1,359 laboratory confirmed cases of COVID-19 were reported to CDC
by cruise ships following the CSO.\35\
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\35\ This number does not include newly embarking crew who
tested positive for SARS-CoV-2 prior to or during their embarkation
quarantine period, or passengers who tested positive for SARS-CoV-2
at embarkation and did not board the ship.
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Several large outbreaks on cruise ships are highlighted below.
On July 24, 2021, one symptomatic passenger who tested
positive for COVID-19 on a cruise ship (Cruise Ship A) was
epidemiologically linked to 20 additional laboratory-confirmed cases of
COVID-19 over two voyages, including 2 passengers and 18 crew. The
COVID-19 vaccination rate on this ship ranged between 99.8-100% for
crew and 96.4-97.5% for passengers.
Between July 24-August 28, a cruise ship (Cruise Ship B)
reported 58 laboratory-confirmed COVID-19 cases among passengers and
crew. The COVID-19 vaccination rate on this ship ranged between 96.8-
97.7% for passengers and averaged 100% for crew.
Between July 29-31, 2021, three symptomatic passengers
tested positive for COVID-19 on a cruise ship (Cruise Ship C). Contact
tracing and testing identified an additional 12 laboratory-confirmed
cases of COVID-19, including 10 passengers and 2 crew. This was a
highly vaccinated ship with 100% of crew and an average of 97% of
passenger fully vaccinated.
Between July 26-August 6, a cruise ship (Cruise Ship D)
reported 7 laboratory-confirmed COVID-19 cases among passengers and
crew. The COVID-19 vaccination rate on this ship was 100% for crew and
ranged between 96.8-97.7% for passengers.
Between August 19-September 7, a cruise ship (Cruise Ship
E) reported 105 laboratory-confirmed COVID-19 cases among passengers
and crew on a total of four consecutive voyages. This was a highly
vaccinated ship with 100% of crew and an average of 97% of passenger
fully vaccinated at the time on the voyage(s).
Between August 21-September 7, a cruise ship (Cruise Ship
F) reported a total of 112 laboratory-confirmed COVID-19 cases among
passengers and crew on four consecutive voyages despite the ships' 100%
vaccination rate for persons onboard.
While high vaccination rates onboard these cruise ships likely
explain why onboard medical center resources have not been overwhelmed,
the number of hospitalizations and medical evacuations due to COVID-19
or CLI have increased since passenger operations resumed. Between June
26-October 21, 2021, 49 hospitalizations and 38 medical evacuations for
COVID-19 or CLI were reported to CDC.
Despite the implementation of strict protocols by cruise ship
operators to prevent the introduction of COVID-19 from passengers,
ensuring passengers are uninfected at embarkation has proven difficult.
There have been several instances of passengers' being symptomatic on
the day of embarkation and denying symptoms to the cruise line, or
passengers' being symptomatic for several days on board the ship before
reporting their symptoms to the medical center. These situations have
led to complex contact tracing investigations, due to the large number
of contacts exposed between presumed onset of infectiousness and when
infection was identified and the passenger isolated.
For example, a passenger on a cruise ship (Cruise Ship F), who was
fully vaccinated and had tested negative for COVID-19 three days before
boarding, boarded the ship while symptomatic for COVID-19, but denied
having symptoms. The passenger died three days after boarding for
reasons related to COVID-19. This led to CDC and the cruise line taking
the following public health actions:
Contact tracing to identify exposed persons, which
included interviews of passengers and crew, review of security footage,
and analysis of wearable
[[Page 59726]]
technology and other relevant location data;
Notifications to close contacts to advise them to monitor
for symptoms, and to federal, state, and local partners in two states;
Screening testing to identify those who could have been
infected;
Isolation for close contacts who tested positive for
COVID-19; and
Quarantine for close contacts who tested negative for
COVID-19 but could have still developed the illness during the
incubation period.
Based on these time-sensitive and labor-intensive public health
actions, the cruise line identified over 30 close contacts from one
infected passenger.
Cruise ship voyages from the U.S. also include itineraries to
countries that have low vaccination rates but are reopening to
international tourism. These countries may have limited testing
capabilities for their populations, which could restrict their ability
to identify COVID-19, including variants of concern. Cruise ship travel
to these countries risks potentially introducing additional variants of
concern into the United States. Based on CDC's assessment of risk and
issuance of Travel Health Notices for international destinations,\36\
travelers may be at increased risk for getting and spreading COVID-19
variants in the following countries where cruise ships intend to sail,
per published itineraries: Aruba, the Bahamas, Barbados, Bermuda,
Belize, Bonaire, Cura[ccedil]ao, Haiti, Honduras, Jamaica, Mexico,
Saint Kitts and Nevis, Sint Maarten, and Turks and Caicos Islands.\37\
Accordingly, based on these risks and information available to CDC, the
CSO continues to represent the best way of protecting the public's
health by mitigating COVID-19 transmission onboard cruise ships and
into the United States.
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\36\ How CDC Determines the Level for COVID-19 Travel Health
Notices.
\37\ COVID-19 in Aruba, COVID-19 in the Bahamas, COVID-19 in
Barbados, COVID-19 in Belize, COVID-19 in Bermuda, COVID-19 in
Bonaire, COVID-19 in Cura[ccedil]ao, COVID-19 in Haiti, COVID-19 in
Honduras, COVID-19 in Jamaica, COVID-19 in Mexico, COVID-19 in Saint
Kitts and Nevis, COVID-19 in Sint Maarten, COVID-19 in Trinidad and
Tobago, and COVID-19 in the Turks and Caicos Islands.
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Findings and Immediate Action
The ongoing COVID-19 pandemic, emergence of variants of concerns,
including the Delta variant, breakthrough infections in fully
vaccinated persons, and possible surges of additional cases,
hospitalizations, and deaths in the U.S. and in countries to which
cruise ships travel support the CSO's temporary extension to mitigate
the risk of further COVID-19 introduction, transmission, and spread
both onboard cruise ships and into U.S. communities.
Finding of Inadequate Local Control Under 42 CFR 70.2
The cruise ships subject to this Order are all foreign-flagged and
operate on international itineraries. State and local health
departments consider public health on cruise ships as primarily subject
to federal jurisdiction and do not routinely exercise oversight or
control over cruise ship operations nor maintain maritime public health
programs, particularly when such cruise ships employ mostly foreign
crews and operate in international waters subject to the jurisdiction
of the United States. Many state and local health departments are also
currently engaged in response activities relating to the COVID-19
pandemic, and do not have the time, money, or public health resources
to dedicate staff and programs to maritime public health activities.
Further, based on legal authority at 42 CFR 71.31(b), CDC is the only
government entity that may impose public health conditions on cruise
ships operating in international waters if those ships plan to return
to operating in U.S. waters. Furthermore, U.S. Coast Guard, not state
and local public health departments, is the only entity that routinely
conducts emergency medical evacuations at sea, including for persons
with COVID-19.
Accordingly, under 42 CFR 70.2, the Director determines that based
on jurisdictional limitations and other factors, the measures taken by
state and local public health authorities in U.S. jurisdictions where
foreign-flagged cruise ships port or travel on international
itineraries and do not routinely exercise public health jurisdiction
nor maintain maritime public health programs that conduct surveillance,
inspections, investigations, and management for diseases of public
health concern on board cruise ships have been and are insufficient to
prevent the spread of COVID-19 into and among U.S. states and
territories.\38\
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\38\ These jurisdictions include the following U.S. states:
Alabama, Alaska, California, Delaware, Florida, Georgia, Hawaii,
Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan,
Minnesota, Mississippi, New Hampshire, New Jersey, New York, North
Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina,
Texas, Virginia, and Washington State. These jurisdictions also
include the following U.S. territories: American Samoa, Guam,
Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands.
CDC is not currently aware of any states or U.S. territories
operating a maritime public health program that would displace the
CSO.
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Statement of Good Cause Under the Administrative Procedure Act
(``APA'')
COVID-19 cases, hospitalizations, and deaths continue to increase,
especially in areas with higher levels of community transmission and
lower vaccination coverage.\39\ Furthermore, while pediatric cases and
hospitalizations have decreased in recent weeks following a previous
increase, cases and hospitalizations could surge again.\40\ Based on
the rapidly increasing cases and spread of the Delta variant and other
variants of SARS-CoV-2, and to reduce introduction and spread of these
and future SARS-CoV-2 variants into the United States, including a
potential variant of high consequence, at a time when cruise ship
travel has resumed, CDC must take quick and targeted action to further
curtail the spread of Delta and other new virus variants into the
United States.
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\39\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
\40\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
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The Director continues to find evidence to support a reasonable
belief that cruise ships are or may be infected or contaminated with a
quarantinable communicable disease.\41\ This reasonable belief is based
on information from epidemiologic and other data.\42\ As a result,
absent measures of the type specified in the
[[Page 59727]]
CSO, persons on board or seeking to board cruise ships may likely be or
would likely become infected with or exposed to the virus that causes
COVID-19 by virtue of being on board at a time when the virus,
including the highly transmissible Delta variant, continues to
circulate globally and in the U.S. Additionally, persons infected on
cruise ships would be likely to transmit COVID-19 to U.S. communities
by traveling interstate after disembarking a cruise ship.
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\41\ The list of federally quarantinable communicable diseases
as defined by Executive Order includes severe acute respiratory
syndromes, defined as diseases that are associated with fever and
signs and symptoms of pneumonia or other respiratory illness, are
capable of being transmitted from person to person, and that either
are causing, or have the potential to cause, a pandemic, or, upon
infection, are highly likely to cause mortality or serious morbidity
if not properly controlled. This definition does not apply to
influenza. See Executive Order 13295 (April 4, 2003), as amended by
Executive Orders 13375 (April 1, 2005), 13674 (July 31, 2014), and
14047 (September 17, 2021). CDC has determined that COVID-19 meets
the definition of a severe acute respiratory syndrome and therefore
is a quarantinable communicable disease.
\42\ Multiple studies have confirmed that COVID-19 transmission
rates onboard cruise ships are higher than in other settings.
Kordsmeyer, A.-C.; Mojtahedzadeh, N.; Heidrich, J.; Militzer, K.;
von M[uuml]nster, T.; Belz, L.; Jensen, H.-J.; Bakir, S.; Henning,
E.; Heuser, J.; et al. Systematic Review on Outbreaks of SARS-CoV-2
on Cruise, Navy and Cargo Ships. Int. J. Environ. Res. Public Health
2021, 18, 5195. https://doi.org/10.3390/ijerph18105195; Rockl[ouml]v
J, Sj[ouml]din 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. https://doi.org/10.1093/jtm/taaa030; 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.
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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). If this
Order qualifies as a rule under the APA, notice and comment and a delay
in effective date are not required because good cause exists to
dispense with prior public notice and the opportunity to further
comment on this Order. Considering the public health emergency caused
by COVID-19, including the Delta variant, based on, among other things,
its potential for spread on board cruise ships and potential to cause
breakthrough infections in vaccinated persons, it would be
impracticable and contrary to the public's health, and by extension the
public's interest, to delay the issuance and effective date of this
Order. 5 U.S.C. 553(b)(B), (d)(3).
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 under Subtitle E of the Small
Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121,
SBREFA), 5 U.S.C. 804(2), but there would not be a delay in its
effective date under 5 U.S.C. 808(2) as the agency has invoked the good
cause provision of the APA. As explained in this Order, during the
pandemic, cases have tended to surge in waves with 4 waves as of
October 2021.\43\ Therefore, additional surges of cases and deaths can
be expected. The winter season (November through January) has
historically been the most active cruising season in the Caribbean and
Central America, involving travel to countries currently listed by CDC
as being under COVID-19 travel health notices where cruise ship
travelers may be at increased risk for acquiring and subsequently
introducing COVID-19 variants into the U.S. Additionally, cruise ship
operators have informed CDC of their intended plans to increase the
number of ships operating in U.S. waters this fall and winter.
Accordingly, in light of the rapidly evolving public health situation
and expected increase in winter cruising activity, pausing the
operation and enforcement of the CSO to allow for a notice and comment
period would be impracticable and contrary to the public interest.
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\43\ https://www.cdc.gov/coronavirus/2019-ncov/science/forecasting/mathematical-modeling.html.
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While it was not feasible based on the rapidly evolving pandemic
and emergence of variants of concern to seek full notice and comment
through rulemaking, CDC solicited specific feedback from cruise ship
operators and other partners relating to the measures in this temporary
CSO extension. Unfortunately, CDC received low response rate to its
solicitation (n=15). Almost three quarters of the respondents were
cruise industry representatives (n=11) and the responses may have
underrepresented non-cruise stakeholder partners (such as state and
local health departments, seaport partners, and U.S. government
interagency partners). Therefore, CDC acknowledges that further
solicitation and feedback are warranted before existing elements of the
CSO are maintained, modified, or rescinded as part of any future
voluntary program.
Based on feedback received, the majority of respondents agreed on
the importance of COVID-19 industry-wide standards including:
Surveillance protocols,
medical protocols, capabilities, and supplies for managing
patients on board, and
preventive measures & public health interventions (e.g.,
mask use, physical distancing, cleaning and disinfection, infection
prevention and control plans).
The majority of respondents also agreed on the importance of
continued communication and close collaboration between CDC and cruise
lines, including through regularly scheduled executive session calls
between cruise lines, CDC, and interagency representatives to exchange
information and share ideas; regularly scheduled technical assistance
calls between CDC's Maritime Unit and cruise lines' public health
personnel; and ad hoc outbreak assistance calls between CDC's Maritime
Unit and cruise lines' medical and public health staff.
While most cruise industry respondents disagreed that port
agreements were useful for the resumption of passenger operations,
respondents were divided as to whether individual components of the
port agreements (e.g., medical care, housing, and vaccination) were
important for future cruise operations. However, based on previous
feedback from state and local health departments and seaport partners,
CDC believes that emergency response planning is an important element
of COVID-19 health and safety protocols that should be a part of future
cruise ship operations. The exact elements of such emergency response
planning would be the subject of further discussion and information
sharing as part of any future voluntary program between CDC and the
cruise ship industry.
Most cruise industry respondents also disagreed that CDC's Cruise
Ship Color Status web page was useful for communicating information
about COVID-19 on cruise ships in U.S. jurisdictions. However, CDC
believes it is important to be transparent and continue to advise the
public about COVID-19 conditions on board cruise ships so that
passengers can make better informed decisions based on their
preexisting medical conditions and risk of severe illness. How best to
inform the public about COVID-19 conditions on board cruise ships would
similarly be the subject of further discussion and information sharing
as it relates to any future voluntary program.
The interest of cruise ship operators in participating in a future
voluntary program to detect, mitigate, and control the spread of COVID-
19 during future cruise ship operations is also difficult to gauge
based on this limited initial feedback. Of the 11 cruise industry
respondents, 4 indicated they would be interested in such a program and
7 indicated that they would not be. Based on written comments received
to this question, some cruise ship operators expressed reticence to
respond in the affirmative in the absence of additional details
regarding the scope and parameters of such a voluntary program.
Regardless, CDC wishes to stress that cruise ship participation in any
future voluntary program would not be mandated; the scope and
parameters of such a program would be subject to further discussion and
information sharing; and cruise ship operators would be free to develop
alternative pathways of detecting, mitigating, and controlling the
spread of COVID-19 onboard cruise ships.
Accordingly, CDC will use the additional time provided by this
temporary extension to better gauge interest in a voluntary program and
continue to explore alternative pathways to detect, mitigate, and
control the spread of COVID-19 onboard cruise ships. During this
temporary extension period, CDC intends to solicit additional feedback
from the cruise industry, state and local
[[Page 59728]]
health departments, seaport partners, and U.S. government interagency
partners as may be needed to explore interest in and develop a
voluntary program to assist the cruise ship industry to detect,
mitigate, and control the spread of COVID-19 onboard cruise ships for
those cruise ship operators who may wish to be involved in such a
program.
Severability of Provisions
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.
Federal Preemption
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.
Enforceability
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. While this
Order may be enforced and CDC reserves the right to enforce in
appropriate circumstances through criminal penalties, CDC does not
intend to rely primarily on these criminal penalties but instead
anticipates continued wide-spread voluntary compliance from cruise ship
operators as well as support from U.S. Coast Guard.
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 as defined in this Order for the period
described below, it is ordered:
Framework for Conditional Sailing Order
Purpose and Scope
(a) Purpose. The purpose of this framework is to prevent the
further introduction, transmission, and spread of COVID-19 into and
throughout the United States via cruise ships. These requirements are
in addition to other requirements in regulations or actions taken by
HHS/CDC to prevent the introduction, transmission, and spread of
communicable diseases under 42 U.S.C. 264 and 42 CFR part 70 and 42 CFR
part 71.
(b) Scope. This framework applies to any person operating or
intending to operate a foreign-flagged cruise ship in U.S. waters and
to any person operating a foreign-flagged cruise ship outside of U.S.
waters if the cruise ship operator intends for the ship to return to
operating in U.S. waters while this Order remains in effect.
(1) Upon request, cruise ship operators must make their properties
and records available for inspection to allow CDC to ascertain
compliance with this framework. Such properties and records include but
are not limited to vessels, facilities, vehicles, equipment,
communications, manifests, list of passengers, and employee and
passenger health records.
(2) CDC may enforce any of the provisions of this framework through
additional orders published in the Federal Register and issue
additional technical instructions as needed.
(3) Nothing in this framework supersedes or preempts enforcement of
emergency response requirements imposed by statutes or other
regulations.
General Prohibition on a Cruise Ship Operator Commencing or Continuing
Passenger Operations Without a COVID-19 Conditional Sailing Certificate
(a) A cruise ship operator subject to this Order must meet the
requirements of this framework as a condition of obtaining or retaining
controlled free pratique for operating a cruise ship in U.S. waters or
if the cruise ship operator is operating a cruise ship outside of U.S.
waters and intends for the ship to return to operating in U.S. waters
while this Order remains in effect. These requirements must
additionally be met as a condition of obtaining or retaining controlled
free pratique for conducting a simulated voyage or applying for a
COVID-19 Conditional Sailing Certificate.
(b) A cruise ship operator shall not commence or continue any
passenger operations in U.S. waters without a COVID-19 Conditional
Sailing Certificate issued by CDC that meets the requirements in this
framework for each cruise ship that the cruise ship operator intends to
operate with passengers in U.S. waters.
(c) A cruise ship operator shall not violate the terms or
conditions of a COVID-19 Conditional Sailing Certificate issued
pursuant to this framework.
(d) As a condition of obtaining or retaining a COVID-19 Conditional
Sailing Certificate, the cruise ship operator must be in compliance
with CDC's standards for mitigating the risk of COVID-19 onboard the
cruise ship as set forth in this framework and in CDC technical
instructions or orders.
Requirements for COVID-19 Response Plan for Cruise Ship Operators
Operating or Intending To Operate Cruise Ships in U.S. Waters \44\
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\44\ COVID-19 response plans were formerly referred to as ``No
Sail Order'' response plans. Cruise ship operators that previously
submitted a signed ``Acknowledgment of No Sail Order Response Plan
Completeness and Accuracy'' to CDC have fulfilled the requirements
of this section and do not need to re-submit a COVID-19 response
plan.
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(a) Cruise ships operating or intending to operate in U.S. waters
must have a COVID-19 response plan that includes the following
components:
(1) Terminology and use of definitions that align with how CDC uses
and defines the following terms: ``confirmed COVID-19,'' ``COVID-19-
like illness,'' ``close contact,'' ``fully vaccinated for COVID-19,''
and ``isolation'' and ``quarantine'' (including timeframes for
isolation and quarantine).
(2) Protocols for on board surveillance of passengers and crew with
COVID-19 and COVID-19-like-illness.
(3) Protocols for training all crew on COVID-19 prevention,
mitigation, and response activities.
(4) Protocols for on board isolation and quarantine, including how
to increase capacity in case of an outbreak.
(5) Protocols for COVID-19 testing that aligns with CDC technical
instructions.
(6) Protocols for onboard medical staffing--including number and
type of staff--and equipment in sufficient quantity to provide a
hospital level of care (e.g., ventilators, face masks, personal
protective equipment) for the infected without the immediate need to
rely on shoreside hospitalization.
(7) Procedures for disembarkation of passengers who test positive
for COVID-19.
(b) The cruise ship operator has observed and will continue to
observe all elements of its COVID-19 response plan including following
the most current CDC recommendations and guidance for any public health
actions related to COVID-19.
[[Page 59729]]
Requirements for COVID-19 Testing Capabilities and Reporting for Cruise
Ship Operators Operating or Intending To Operate Cruise Ships in U.S.
Waters \45\
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\45\ This section does not impose new requirements on cruise
ship operators but merely restates requirements that cruise ship
operators previously fulfilled during Phase 1 of the CSO. These
requirements were previously published under the section
``Requirements for Protection of Crew for Cruise Ship Operators
Operating or Intending to Operate Cruise Ships in U.S. Waters.''
---------------------------------------------------------------------------
(a) Cruise ships operating or intending to operate in U.S. waters
must have onboard testing capabilities as directed by CDC in technical
instructions or orders to test all symptomatic crew and passengers for
COVID-19 and their close contacts. These capabilities include having
onboard rapid nucleic acid amplification test (NAAT) point-of-care
equipment that meets the requirements specified by CDC in technical
instructions or orders.\46\ This testing instrument must be authorized
by FDA for use in a CLIA-waived setting, have been evaluated on the FDA
reference panel for SARS-CoV-2,\47\ allow for specimen-to-instrument
transfer in a way that minimizes the risk of contamination, and possess
a limit of detection (LoD) value <=18,000 NDU/ml.
---------------------------------------------------------------------------
\46\ Technical Instructions for Mitigation of COVID-19 Among
Cruise Ship Crew [verbarlm] Quarantine [verbarlm] CDC.
\47\ For tests that do not have the FDA reference panel
available, tests will be accepted using sensitivity data >=95% from
clinical samples as indicated in the manufacturer's instructions for
use.
---------------------------------------------------------------------------
(b) Cruise ships operating in U.S. waters must continue to submit
the EDC form as specified in CDC technical instructions or orders.
Cruise ship operators with ships that have not been in U.S. waters
during the period of the CSO and who wish to operate those ships in
U.S. waters during the period that this framework remains in effect,
must additionally submit the EDC form during (at a minimum) the 14 days
preceding those ships' expected arrival in U.S. waters and continue to
submit the EDC form after the ships' entering U.S. waters or,
alternatively, arrange for such appropriate shoreside or ship-based
testing of passengers and crew as directed by CDC with subsequent
submission of the EDC form after the ships' arrival.
(c) The cruise ship operator has arranged for and submitted and
will continue to arrange for and submit such COVID-19 test results as
may be required by CDC for every crew member on board ships operating
in U.S. waters and/or operating outside of U.S. waters if the cruise
ship operator intends for the ship to return to operating in U.S.
waters at any time while this Order remains in effect. Routine COVID-19
screening testing of all crew must be conducted at such other intervals
as required by CDC in technical instructions or orders. CDC may conduct
oversight of specimen collection, testing, and laboratory procedures,
as necessary.
(d) CDC may issue additional requirements through technical
instructions or orders relating to a cruise ship operator's processes
and procedures for protection of crew.
Agreement With Port and Local Health Authorities \48\
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\48\ Cruise ship operators that previously submitted and had
their port and local health agreements accepted by CDC are not
required to take any further action under this section if such
agreements continue to remain in effect.
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(a) As a condition of obtaining or retaining controlled free
pratique for conducting a simulated voyage or obtaining and retaining a
COVID-19 Conditional Sailing Certificate, a cruise ship operator must
document the approval of all U.S. port and local health authorities
where the ship intends to dock or make port during a simulated voyage
or a restricted passenger voyage. Such written approval must include
the following:
(1) A medical care agreement between the cruise ship operator and
health care entities, addressing evacuation to onshore hospitals for
passengers and crew in need of care, in accordance with CDC technical
instructions and orders.\49\
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\49\ https://www.cdc.gov/quarantine/cruise/instructions-local-agreements.html.
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(2) A housing agreement between the cruise ship operator and one or
more shoreside facilities for isolation and quarantine of COVID-19
cases and close contacts, respectively, identified from the day of
embarkation through disembarkation for each voyage, in accordance with
CDC technical instructions and orders.
(3) A port agreement between the cruise ship operator and port
authority that takes into consideration the public health response
resources of the jurisdiction in the event of a COVID-19 outbreak, a
plan and timeline for vaccination of cruise ship crew prior to resuming
passenger operations, and vaccination strategies to maximally protect
passengers and crew from introduction, amplification, and spread of
COVID-19 in the maritime environment and in land-based communities.
(b) In lieu of documenting the approval of all local health
authorities of jurisdiction, the cruise ship operator may instead
submit to CDC a signed statement from a local health authority, on the
health authority's official letterhead, indicating that the health
authority has declined to participate in deliberations and/or sign the
port agreement, i.e., a ``Statement of Non-Participation.''
(c) In documenting the approval of all U.S. port and local health
authorities where the ship intends to dock or make port during
simulated voyages or restricted passenger voyages, the cruise ship
operator may enter into a multi-port agreement (as opposed to a single
port agreement) provided that all relevant port and local health
authorities (including the state health authorities) are signatories to
the agreement.
Minimum Standards for Simulated Voyages Prior to Issuance of COVID-19
Conditional Sailing Certificate
(a) As a condition of applying for a COVID-19 Conditional Sailing
Certificate, a cruise ship operator must have successfully conducted a
simulated voyage demonstrating the cruise ship operator's ability to
mitigate the risks of COVID-19 onboard its cruise ship. A simulated
voyage must meet the following requirements: \50\
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\50\ https://www.cdc.gov/quarantine/cruise/ti-simulated-voyages-cso.html.
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(1) The cruise ship operator must inform volunteer passengers in
writing that they are participating in a simulation of health and
safety protocols for purposes of simulating a cruise ship voyage.
(2) All volunteer passengers must be at least twelve years old or
older. The cruise ship operator must also obtain from all volunteer
passengers a written certification from a healthcare provider that the
volunteer passenger has no pre-existing medical conditions that would
place that individual at high risk for COVID-19 as determined through
CDC guidance. CDC may issue additional requirements through technical
instructions or orders relating to a cruise ship operator's obligation
to screen for volunteer passengers who may be at high risk for COVID-
19.
(3) The cruise ship operator must conduct any simulation on a
consensual basis. The cruise ship operator must document the informed
consent of all adult participants in writing. If any minors are to
participate in the simulation then the informed consent of a parent or
guardian, and the written assent of the minor must also be documented
in writing. All persons younger than eighteen years old must be fully
vaccinated against COVID-19 as a
[[Page 59730]]
condition of participation on a simulated voyage.
(4) The cruise ship operator must design and conduct a simulated
voyage insofar as practicable to test the efficacy of the cruise ship
operator's ability to mitigate the risks of COVID-19 onboard its cruise
ship.
(5) The cruise ship operator must conduct laboratory testing of
volunteer passengers, as directed in CDC technical instructions or
orders, prior to embarking volunteer passengers on a simulated voyage.
(6) A simulated voyage must include the following simulated
activities:
(i) Embarkation and disembarkation procedures, including terminal
check-in,
(ii) on board activities, including at dining and entertainment
venues,
(iii) private island shore excursions, if any are planned during
restricted passenger voyages,
(iv) evacuation procedures,
(v) transfer of symptomatic passengers or crew, or those who test
positive for SARS-CoV-2, from cabins to isolation rooms,
(vi) quarantine of all remaining passengers and non-essential crew,
and
(vii) other activities as may be listed in CDC technical
instructions and orders.
(7) The cruise ship operator must meet standards for hand hygiene,
facemasks, and physical distancing for passengers and crew, as well as
ship sanitation, as may be required by CDC technical instructions or
orders.
(8) The cruise ship operator must modify meal service and
entertainment venues to facilitate physical distancing during the
simulated voyage.
(9) The cruise ship operator must conduct laboratory testing of all
passengers and crew on the day of embarkation and the day of
disembarkation as required by CDC technical instructions or orders.
Laboratory test results must be available prior to passengers embarking
and prior to passengers and crew departing for their final destinations
after disembarking the ship. Crew and passengers must also be
laboratory tested again post-disembarkation as required by CDC
technical instructions or orders. Based on public health
considerations, CDC may also require additional laboratory testing of
passengers and crew and reporting of results, including during a
voyage, as required by CDC technical instructions or orders.
(10) The cruise ship operator must immediately conduct laboratory
testing of any passengers and crew who report illness consistent with
COVID-19 during the simulated voyage with rapid point-of-care results
as required by CDC technical instructions or orders. Identified close
contacts of cases must also be laboratory tested with rapid point-of-
care results.
(11) CDC may require the cruise ship operator to immediately end
the simulated voyage and take other action to protect the health and
safety of volunteer passengers and crew if during the simulation a
threshold of COVID-19 cases, as determined by CDC in technical
instructions, is met or exceeded.\51\
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\51\ During simulated passenger voyages, this threshold is
currently met when 1.5% of COVID-19 cases is detected in passengers
or 1.0% of COVID-19 cases is detected in crew. This threshold may be
modified based on lessons learned from simulated voyages or
restricted passenger voyages, the evolution of the pandemic, or
other factors. If a simulated voyage is ended early to protect
health and safety, CDC will consult with the cruise ship operator
regarding any deficiencies to be noted in the operator's action-
action report and how such deficiencies are to be corrected prior to
approving an application for a COVID-19 Conditional Sailing
Certificate.
---------------------------------------------------------------------------
(12) The cruise ship operator must document any deficiencies in its
health and safety protocols through an ``after-action'' report and
address how the cruise ship operator intends to address those
deficiencies prior to applying for a COVID-19 Conditional Sailing
Certificate. This after-action report must also include test results
for any volunteer passengers or crew on the simulated voyage. The
after-action report must be submitted to the CDC as soon as practicable
at the end of the simulation and as part of the cruise ship operator's
application for a COVID-19 Conditional Sailing Certificate.
(13) Based on CDC's review of the after-action report and/or cruise
ship operator's application for a COVID-19 Conditional Sailing
Certificate, CDC may require that the cruise ship operator modify its
practices or procedures prior to the issuance of the COVID-19
Conditional Sailing Certificate.
(b) Prior to conducting a simulated voyage in accordance with this
section, the cruise ship operator must provide written notice and
request CDC's approval to conduct the simulation. Such written notice
must be provided prior to the simulation and specify the time,
location, contact information for all individuals or parties involved,
and protocols or practices to be simulated. This written notice must be
submitted at least 5 business days prior to the date on which the
cruise ship operator proposes to conduct the simulation.
(c) A cruise ship operator shall not apply for approval to conduct
a simulated voyage until all of CDC's requirements relating to onboard
laboratory capacity and screening testing of crew in U.S. waters have
been satisfied. The cruise ship operator's responsible officials must
sign the application for permission to conduct a simulation and certify
that all of CDC's requirements relating to onboard point-of-care
laboratory capabilities and screening testing of crew onboard cruise
ships in U.S. waters have been satisfied.
(d) CDC will respond to the written notice and request for approval
to conduct a simulation in writing in a timely manner. CDC may deny the
request to conduct a simulation if the cruise ship operator is not in
compliance with any provision of this framework, technical
instructions, or orders, or if in CDC's determination the simulation
does not provide adequate safeguards to minimize the risk of COVID-19
for all participants.
(e) CDC may conduct such oversight and inspection of simulated
voyages as it deems necessary in its discretion, including through in-
person or remote means allowing for visual observation.
(f) CDC may issue additional requirements through technical
instructions or orders relating to a cruise ship operator's processes
and procedures for conducting and evaluating a simulated voyage prior
to applying for a COVID-19 Conditional Sailing Certificate.
(g) In lieu of conducting a simulated voyage, cruise ship operator
responsible officials, at their discretion, may sign and submit to CDC
an acknowledgement that 95% of crew (excluding any newly embarking crew
in quarantine) are fully vaccinated and submit to CDC a clear and
specific vaccination plan and timeline to limit cruise ship sailings to
95% of passengers who have been verified by the cruise ship operator as
fully vaccinated prior to sailing.
(h) In lieu of conducting a simulated voyage under this paragraph,
cruise ship operators, at their discretion, may choose to follow the
procedures for modified simulated voyages if transitioning to voyages
with less than 95% of passengers fully vaccinated or if operating
cruise ships outside of U.S. waters and intending to operate with less
than 95% of passengers fully vaccinated after repositioning to U.S.
waters.
Procedures in Lieu of Conducting a Simulated Voyage for Cruise Ship
Operators Transitioning to Voyages With Less Than 95% of Passengers
Fully Vaccinated
(a) Cruise ships that have been operating restricted passenger
voyages
[[Page 59731]]
under an acknowledgement by the cruise ship operator's responsible
officials that they will only operate with 95% of crew (excluding any
newly embarking crew in quarantine) and 95% of passengers who are fully
vaccinated may, at their discretion, transition to operating restricted
passenger voyages with less than 95% of passengers fully vaccinated
without first conducting a simulated voyage if the following are met:
(1) The ship must maintain a percentage of fully vaccinated crew
that is greater than or equal to 95%.
(2) The ship must have operated on restricted passenger voyages
under an acknowledgement by the cruise ship operator's responsible
officials that they will only operate with 95% of crew (excluding any
newly embarking crew in quarantine) and 95% of passengers who are fully
vaccinated for at least 60 days.
(3) At least 14 days prior to the transition to voyages with less
than 95% of passengers fully vaccinated, the cruise ship operator must
submit the following to CDC:
(i) Protocols for how dining and entertainment venues, and
recreational activities including buffets, seated dining, bars
(including between bartenders and patrons), theaters, other performance
venues, casinos, arcade room, spa services, fitness classes/gymnasiums,
muster drills, and other areas where passengers congregate will be
modified to incorporate mask use, physical distancing, and other public
health measures as outlined in CDC technical instructions.\52\
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\52\ COVID-19 Operations Manual for Simulated and Restricted
Voyages under the Framework for Conditional Sailing Order [verbarlm]
Quarantine [verbarlm] CDC.
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(ii) Plans for training crew on new procedures for mask use,
physical distancing, and other public health measures as outlined in
CDC technical instructions.
(iii) Protocols for increasing the number of isolation and
quarantine cabins and on-board support staff (e.g., administrative
personnel, testing personnel, contact tracers, medical personnel) as
determined by the cruise ship operator and as needed in the event of an
outbreak.
(iv) Procedures for how crew will identify and distinguish between
passengers who are fully vaccinated and passengers who are not fully
vaccinated.
(v) Procedures for notifying passengers who booked a 95% passenger
vaccinated cruise that their cruise will no longer operate as a 95%
passenger vaccinated cruise.
(vi) The cruise ship operator must submit photographs or videos, no
later than 7 days after commencing the first voyage with less than 95%
of passengers fully vaccinated, showing compliance with indoor mask use
and physical distancing, such as signage in elevators, dining table
arrangements, and blocking out seats/bar stools.
Modified Simulated Voyage Requirements in Lieu of a Full Simulated
Voyage for Cruise Ship Operators Repositioning to U.S. Waters and
Intending To Operate With Less Than 95% of Passengers Fully Vaccinated
(a) Cruise ship operators that have been conducting passenger
operations outside of U.S. waters and intend to operate cruise ships
with less than 95% of passengers fully vaccinated after repositioning
to U.S. waters may, at their discretion, follow the procedures in this
paragraph for conducting a modified simulated voyage instead of
conducting a full simulated voyage if the following are met:
(1) The ship must maintain a percentage of fully vaccinated crew
that is greater than or equal to 95%.
(2) The ship must have operated with passengers outside of U.S.
waters for at least 60 days before entering U.S. waters.
(3) The cruise ship operator must conduct at least one simulation
of embarkation screening and testing at the port terminal it intends to
use in the U.S.--to include the number of passengers not fully
vaccinated expected on the first voyage--unless the ship will be
operating at the terminal already in use by the same cruise line/brand
for passenger operations.
(4) At least 14 days prior to entering U.S. waters, the cruise ship
operator must submit the following to CDC:
(i) Protocols for how dining and entertainment venues, and
recreational activities, including buffets, seated dining, bars
(including between bartenders and patrons), theaters, other performance
venues, casinos, arcade room, spa services, fitness classes/gymnasiums,
muster drills, and other areas where passengers congregate will
incorporate mask use, physical distancing, and other public health
measures as outlined in technical instructions.
(ii) Plans for training crew on procedures for mask use, physical
distancing, and other public health measures as outlined in CDC
technical instructions.
(iii) Protocols for increasing the number of isolation and
quarantine cabins and on-board support staff (e.g., administrative
personnel, testing personnel, contact tracers, medical personnel) as
determined by the cruise ship operator and as needed in the event an
outbreak.
(iv) Procedures for how crew will identify and distinguish between
passengers who are fully vaccinated and passengers who are not fully
vaccinated.
(v) Procedures for notifying passengers who booked a 95% vaccinated
cruise that their cruise will no longer operate as a 95% vaccinated
cruise, if applicable.
(vi) An after-action report explaining lessons learned from sailing
outside of U.S. waters and from the simulated embarkation screening and
testing (if such a simulation was conducted).
(vii) The cruise ship operator must submit photographs or videos,
no later than 7 days after commencing the first voyage with less than
95% of passengers fully vaccinated, showing compliance with indoor mask
use and physical distancing, such as signage in elevators, dining table
arrangements, and blocking out seats/bar stools.
Applying for a COVID-19 Conditional Sailing Certificate \53\
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\53\ Cruise ship operators who have previously submitted and
received a COVID-19 Conditional Sailing Certificate are not required
to take any further action under this section.
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(a) A cruise ship operator must submit the following to CDC at
least 5 business days prior to the date on which the cruise ship
operator proposes to commence restricted passenger operations:
(1) A completed CDC registration/application form that includes the
signatures of the cruise ship operator's responsible officials.
(2) The name, titles, and contact information for the cruise ship
operator's responsible officials.
(3) A completed statement of intent stating the name, carrying
capacity for passengers and crew, itinerary, ports of call, length of
voyage, and expected onboard or shoreside activities, for the cruise
ship that the cruise ship operator intends to have certified for
restricted passenger operations.
(4) A certification statement signed by the responsible officials
acknowledging that the cruise ship operator has complied and remains in
compliance with CDC's requirements for a COVID-19 Response Plan and EDC
reporting prior to applying for a COVID-19 Conditional Sailing
Certificate.
(5) A certification statement signed by the responsible officials
acknowledging that the cruise ship operator has adopted health and
safety protocols that meet CDC's standards for mitigating the risk of
COVID-19 among passengers and
[[Page 59732]]
crew onboard the cruise ship that will be commencing restricted
passenger operations and will modify these protocols as needed to
protect the public's health as required by CDC technical instructions
or orders.
(6) A certification statement signed by the responsible officials
acknowledging that the cruise ship operator has sufficient medical and
point-of-care laboratory capabilities and staff on board the cruise
ship that will be commencing restricted passenger operations to manage
severe COVID-19 cases and outbreaks in exigent circumstances as
required by CDC technical instructions or orders.
(7) A certification statement signed by the responsible officials
acknowledging that the cruise ship operator is in compliance with the
other requirements contained in this framework for mitigating the risk
of COVID-19 on board cruise ships and agrees to continue to comply with
these requirements.
Review of an Application for a COVID-19 Conditional Sailing Certificate
(a) Upon receiving the documentation required by this framework,
CDC will review the application for completeness. Based on CDC's
determination as to whether the cruise ship operator has met CDC's
standards for mitigating the risk of COVID-19 onboard the cruise ship
for which the operator intends to commence restricted passenger
operations, it shall grant or deny the application. If CDC requires
additional information to ascertain whether the cruise ship operator
has met CDC's standards for mitigating the risk of COVID-19 on board
cruise ships, or if it determines the application to be incomplete, it
may hold the application in abeyance, or in its discretion
provisionally grant the application, pending the submission of such
additional information as required by CDC to make such a determination.
Applications that are denied may be administratively appealed as
described in this framework.
(b) CDC may limit the terms or conditions of a cruise ship
operator's COVID-19 Conditional Sailing Certificate in regard to
passenger or crew capacity, itinerary, ports of call, length of voyage,
onboard or shoreside activities, or in regard to any other passenger,
crew, or cruise ship operations, as needed to the health and safety of
passengers and crew or the public's health.
(c) As a condition of obtaining or retaining a COVID-19 Conditional
Sailing Certificate, the cruise ship operator must upon request make
its properties and records available for inspection to allow CDC to
ascertain compliance with this framework. Such properties and records
include but are not limited to vessels, facilities, vehicles,
equipment, communications, manifests, list of passengers, and employee
and passenger health records. The cruise ship operator must also make
any crew member or other personnel involved in the operation of a
cruise ship available for interview by CDC.
(d) As a condition of obtaining or retaining a COVID-19 Conditional
Sailing Certificate, cruise ship operators must establish mechanisms to
ensure compliance, including reporting mechanisms to notify CDC and
U.S. Coast Guard in writing within 24 hours of the occurrence of any
deviations, whether intentional, or as a result of error or omission,
and take corrective steps to rectify those deviations.
(e) As a condition of obtaining or retaining a COVID-19 Conditional
Sailing Certificate, cruise ship operators must comply with the
requirements of this framework. These requirements apply to any cruise
ship operating in U.S. waters and to cruise ships operating outside of
U.S. waters if the cruise ship operator intends for the ship to return
to operating in U.S. waters at any time while Order remains in effect.
Amendment or Modification of COVID-19 Conditional Sailing Certificate
(a) A cruise ship operator may seek to amend or modify a COVID-19
Conditional Sailing Certificate issued under this framework by
submitting such amendment or modification to CDC for review and a
determination in accordance with this section.
(b) CDC will review the cruise ship operator's request to amend or
modify a COVID-19 Conditional Sailing Certificate and either grant or
deny the request in writing. If CDC requires additional information to
ascertain whether the cruise ship operator's proposed amendment or
modification meets CDC's standards for mitigating the risk of COVID-19
on board cruise ships, or if it determines the request to be
incomplete, it may hold the request in abeyance, or in its discretion
provisionally grant the application, pending the submission of such
additional information as required by CDC to make such a determination.
(c) CDC may require any cruise ship operator to amend or modify a
COVID-19 Conditional Sailing Certificate based on public health
considerations specific to the cruise ship, cruise ship operator, or
affecting the health or safety of cruise travel as a whole.
(d) Denials of requests to amend or modify a COVID-19 Conditional
Sailing Certificate are subject to administrative review as described
in this framework.
Minimum Standards for Restricted Passenger Voyages as a Condition of
Obtaining and Retaining a COVID-19 Conditional Sailing Certificate
(a) As a condition of obtaining and retaining a COVID-19
Conditional Sailing Certificate, a cruise ship operator must meet the
following minimum standards:
(1) The cruise ship operator must screen passengers and crew before
they embark for signs and symptoms or known exposure to COVID-19 and
deny boarding to anyone who is suspected of having COVID-19 or is an
identified contact of a confirmed or suspected case, in accordance with
CDC technical instructions or orders.54 55
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\54\ COVID-19 Operations Manual for Simulated and Restricted
Voyages under the Framework for Conditional Sailing Order [verbarlm]
Quarantine [verbarlm] CDC.
\55\ Technical Instructions for Mitigation of COVID-19 Among
Cruise Ship Crew [verbarlm] Quarantine [verbarlm] CDC.
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(2) The cruise ship operator must conduct laboratory testing of all
passengers and crew on the day of embarkation and the day of
disembarkation in accordance with CDC technical instructions or orders.
Laboratory test results must be available prior to passengers embarking
and prior to passengers and crew departing for their final destinations
after disembarking the ship.
(3) The cruise ship operator must immediately conduct laboratory
testing of any passengers and crew who report illness consistent with
COVID-19 during the voyage with rapid point-of-care results as required
by CDC technical instructions or orders. Identified close contacts of
cases must also be laboratory tested with rapid point-of-care results.
(4) The cruise ship operator must report syndromic surveillance and
all laboratory test results using CDC's EDC form as required by CDC
technical instructions or orders.
(5) The cruise ship operator must meet standards for hand hygiene,
face masks, and physical distancing for passengers and crew, as well as
ship sanitation, as required by CDC technical instructions or orders.
(6) The cruise ship operator must modify meal service and
entertainment venues to facilitate physical distancing as required by
CDC technical instructions or orders.
(b) In light of public health considerations and based on evidence
gained through review and evaluation of
[[Page 59733]]
cruise operators' practices and procedures, including through simulated
voyages, CDC may require the following:
(1) Post-day of disembarkation laboratory testing of passengers and
crew.
(2) Additional laboratory testing of passengers and crew and
reporting of results during a voyage.
(c) CDC may issue additional technical instructions or orders
regarding health and safety standards for restricted passenger voyages.
Minimum Standards for Management of Passengers and Crew From COVID-19-
Affected Cruise Ships for Restricted Passenger Voyages
(a) Based on COVID-19 being detected in passengers or crew, as
determined through CDC technical instructions or orders, a cruise ship
operator must immediately take the following actions:
(1) Conduct such notifications of passengers, crew members, and
other government entities as CDC may require.
(2) Immediately isolate any sick or infected passengers and crew in
single occupancy cabins with private bathrooms and quarantine all
remaining passengers and non-essential crew.
(3) Disembark and evacuate passengers and crew only in such a
manner as prescribed in the cruise ship operator's preexisting port and
local health authority agreements.
(4) Arrange to disembark and transport passengers and crew using
noncommercial transportation or other transportation in accordance with
CDC's technical instructions and orders.
(5) Instruct disembarking passengers and crew to stay home and
continue to practice physical distancing after reaching their final
destination as per CDC technical instructions or orders.
(6) Inform ship pilots, ground transportation, aircraft operators,
and other agencies with relevant jurisdiction that COVID-19 has been
detected in passengers or crew and confirm that the operators have
plans in place to notify and protect the health and safety of their
staff (e.g., drivers, air crews).
(7) If the ship meets the red ship criteria,\56\ immediately end
the restricted passenger voyage, cancel future restricted passenger
voyages until directed by CDC that such voyages may resume, and return
the ship to the U.S. port of embarkation.
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\56\ A ship will be considered as meeting red ship criteria if
the ship has sustained transmission of COVID-19 or CLI, or potential
for COVID-19 cases to overwhelm on board medical center resources.
CDC may adjust these criteria based on lessons learned from
simulated voyages or restricted passenger voyages, the evolution of
the pandemic, or other factors.
---------------------------------------------------------------------------
(b) CDC may issue additional technical instructions or orders
regarding what measures cruise ship operators must take in the event
that a threshold of COVID-19 cases is detected in passengers or crew.
Denials, Suspension, Revocation, and Reinstatement of a Cruise Ship
Operator's COVID-19 Conditional Sailing Certificate
(a) CDC may deny an application for a COVID-19 Conditional Sailing
Certificate, or revoke, or suspend a COVID-19 Conditional Sailing
Certificate if:
(1) The cruise ship operator is not in compliance with CDC's
standards for mitigating the risk of COVID-19 on board cruise ships; or
(2) the cruise ship operator is not in compliance with the terms of
its COVID-19 Conditional Sailing Certificate; or
(3) necessary to protect human health or safety based on public
health considerations specific to the particular cruise ship operator,
cruise ship, or affecting cruise travel as a whole.
(b) CDC may reinstate a suspended or revoked COVID-19 Conditional
Sailing Certificate after:
(1) Inspecting the cruise ship operator's properties and records,
including, but are not limited to, its vessels, facilities, vehicles,
equipment, communications, manifests, list of passengers, and employee
and passenger health records;
(2) conferring with the cruise ship operator, responsible
officials, or other persons under the cruise ship operator's employ;
and
(3) receiving information and written assurances from the cruise
ship operator and/or its responsible officials that any deficiencies
have been rectified and actions taken to ensure future compliance.
Administrative Review
(a) A cruise ship operator may appeal a denial of its application
for a COVID-19 Conditional Sailing Certificate or a revocation or
suspension of its COVID-19 Conditional Sailing Certificate based on
specific factors particular to that operator.
(b) The cruise ship operator's appeal must be in writing, state the
factual basis for the appeal, and be submitted to the CDC Director
within 30 calendar days of the decision.
(c) The CDC Director's decision will be issued in writing and will
constitute final agency action. Prior to deciding upon an appeal, the
Director may further investigate the reasons for the denial,
revocation, or suspension, including by conferring with the cruise ship
operator, responsible officials, or other persons under the cruise ship
operator's employ.
This Order enters into effect on November 1, 2021 at 12:01 a.m.
(EDT) upon the expiration of the current Order. While this temporary
extension retains current requirements in place and does not impose any
new obligations or burdens, CDC is committed to working with cruise
ship operators who have requested a minimum of 14 days' advance notice
to inform their passenger clientele, adjust itineraries as needed, and
extend existing contractual arrangements and memorandums of
understanding with port, housing, and medical providers.
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) January 15, 2022 at 12:01 a.m. (EST).
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).
Dated: October 25, 2021.
Sherri Berger,
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2021-23573 Filed 10-26-21; 11:15 am]
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