Notice2021-26603
Requirements for Negative Pre-Departure Covid-19 Test Result or Documentation of Recovery From Covid-19 for All Airline or Other Aircraft Passengers Arriving Into the United States From Any Foreign Country
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 7, 2021
Effective
December 6, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces an Amended Order requiring a negative pre-departure COVID-19 test result or documentation of recovery from COVID-19 for all airline or other aircraft passengers arriving into the United States from any foreign country. This Amended Order was signed by the CDC Director on December 2, 2021, and supersedes the previous Order signed by the CDC Director on October 25, 2021.
Full Text
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<title>Federal Register, Volume 86 Issue 232 (Tuesday, December 7, 2021)</title>
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[Federal Register Volume 86, Number 232 (Tuesday, December 7, 2021)]
[Notices]
[Pages 69256-69284]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26603]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Requirements for Negative Pre-Departure Covid-19 Test Result or
Documentation of Recovery From Covid-19 for All Airline or Other
Aircraft Passengers Arriving Into the United States From Any Foreign
Country
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of amended Agency Order.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS), announces an
Amended Order requiring a negative pre-departure COVID-19 test result
or documentation of recovery from COVID-19 for all airline or other
aircraft passengers arriving into the United States from any foreign
country. This Amended Order was signed by the CDC Director on December
2, 2021, and supersedes the previous Order signed by the CDC Director
on October 25, 2021.
DATES: This Amended Order will become effective at 12:01 a.m. on
December 6, 2021.
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. Email:
<a href="/cdn-cgi/l/email-protection#dcb8bbb1adacb3b0b5bfa5b3babab5bfb99cbfb8bff2bbb3aa"><span class="__cf_email__" data-cfemail="c5a1a2a8b4b5aaa9aca6bcaaa3a3aca6a085a6a1a6eba2aab3">[email protected]</span></a>. Telephone: 1-800-232-4636.
SUPPLEMENTARY INFORMATION: This Amended Order updates COVID-19 testing
requirements for air passengers 2 years or older boarding a flight to
the United States.
This Amended Order prohibits the boarding of any passenger 2 years
or older on any airline or aircraft destined to the United States from
a foreign country unless the passenger presents paper or digital
documentation of one of the following requirements:
(i) A negative pre-departure viral test result for SARS-CoV-2
conducted on a specimen collected no more than 1 calendar day before
the flight's departure from a foreign country (Qualifying Test)
Or
(ii) Documentation of having recovered from COVID-19 in the past 90
days in the form of both of the following (Documentation of Recovery):
<bullet> A positive viral test result for SARS-CoV-2 conducted on a
specimen
[[Page 69257]]
collected no more than 90 calendar days before the flight; and
<bullet> A letter from a licensed healthcare provider or public
health official stating that the passenger has been cleared for travel.
This Amended Order also constitutes a controlled free pratique to
any airline or other aircraft operator with an aircraft arriving into
the United States. Pursuant to this controlled free pratique, the
airline or other aircraft operator must comply with the requirements
outlined in the Order.
A copy of the Amended Order and Passenger Attestation form is
provided below. A copy of the signed Amended Order and Passenger
Attestation form can be found at <a href="https://www.cdc.gov/quarantine/fr-proof-negative-test.html">https://www.cdc.gov/quarantine/fr-proof-negative-test.html</a>.
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) DEPARTMENT OF HEALTH
AND HUMAN SERVICES (HHS)
NOTICE AND AMENDED ORDER UNDER SECTION 361 OF THE PUBLIC HEALTH SERVICE
ACT (42 U.S.C. 264) AND 42 CODE OF FEDERAL REGULATIONS 71.20 & 71.31(b)
REQUIREMENTS FOR NEGATIVE PRE-DEPARTURE COVID-19 TEST RESULT OR
DOCUMENTATION OF RECOVERY FROM COVID-19 FOR ALL AIRLINE OR OTHER
AIRCRAFT PASSENGERS ARRIVING INTO THE UNITED STATES FROM ANY FOREIGN
COUNTRY
Summary
Pursuant to 42 CFR 71.20 and 71.31(b) and as set forth in greater
detail below, this Notice and Amended Order prohibits the boarding of
any passenger--2 years of age or older--on any aircraft destined to the
United States \1\ from a foreign country unless the passenger: \2\
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\1\ This includes any flight regardless of whether the United
States is the final destination or a connection to another country.
\2\ A parent or other authorized individual may present the
required documentation on behalf of a passenger 2-17 years of age.
Children under the age of 2 years of age are not subject to the
requirements of this Amended Order. An authorized individual may act
on behalf of any passenger who is unable to act on their own behalf
(e.g., by reason of age, or physical or mental impairment).
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Presents paper or digital documentation of one of the following
requirements:
(iii) A negative pre-departure viral test result for SARS-CoV-2
conducted on a specimen collected no more than 1 calendar day before
the flight's departure from a foreign country (Qualifying Test)
Or
(iv) Documentation of having recovered from COVID-19 in the past 90
days in the form of both of the following (Documentation of Recovery):
<bullet> A positive viral test result for SARS-CoV-2 conducted on a
specimen collected no more than 90 calendar days before the flight; and
<bullet> A letter from a licensed healthcare provider or public
health official stating that the passenger has been cleared for travel.
Each passenger must retain paper or digital documentation presented
to the airline or other aircraft operator reflecting one of the
following:
<bullet> A negative result for the Qualifying Test; or
<bullet> Documentation of Recovery from COVID-19.
Upon request, a passenger, or the passenger's authorized
representative, must also produce such documentation to any U.S.
government official or a cooperating state or local public health
authority.
Pursuant to 42 CFR 71.31(b), and as set forth in greater detail
below, this Notice and Amended Order constitutes a controlled free
pratique to any airline or other aircraft operator with an aircraft
arriving into the United States.\3\ Pursuant to this controlled free
pratique, the airline or other aircraft operator must comply with the
following conditions to receive permission for the aircraft to enter
and disembark passengers within the United States:
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\3\ On October 25, 2021, the President issued a Proclamation,
titled, ``Advancing the Safe Resumption of Global Travel During the
COVID-19 Pandemic.'' On November 26, 2021, the President issued a
Proclamation, titled, ``A Proclamation on Suspension of Entry as
Immigrants and Nonimmigrants of Certain Additional Persons Who Pose
a Risk of Transmitting Coronavirus Disease 2019.'' These
Proclamations were issued pursuant to Sections1182(f) and 1185(a)(1)
of Title 8, and Section 301 of Title 3, United States Code. This
amended CDC Order complements and advances these Proclamations.
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<bullet> Airline or other aircraft operator must confirm that every
passenger onboard the aircraft has presented a negative result for a
Qualifying Test or Documentation of Recovery.
<bullet> Airline or other aircraft operator must verify that every
passenger onboard the aircraft has attested to receiving a negative
result for the Qualifying Test or having tested positive for SARS-CoV-2
on a specimen collected no more than 90 calendar days before the flight
and been cleared to travel as Documentation of Recovery.
This Notice and Amended Order does not alter the obligation of
persons to comply with the applicable requirements of other CDC Orders,
including:
<bullet> Requirement for Persons to Wear Masks While on Conveyances
and at Transportation Hubs (published at 86 FR 8025, February 3, 2021)
(as may be further amended);
<bullet> Amended Order Implementing Presidential Proclamation on
Advancing the Safe Resumption of Global Travel During the COVID-19
Pandemic (published at 86 FR 61224, November 5, 2021); and
<bullet> Other CDC Orders or CDC Directives that may be published
relating to preventing the introduction, transmission, and spread of
COVID-19 into and throughout the United States.
This Notice and Amended Order supersede the previous Order signed
by the CDC Director on October 25, 2021. This Order shall enter into
effect for flights departing at or after 12:01 a.m. EST (5:01 a.m. GMT)
on December 06, 2021.
Statement of Intent
This Amended Order shall be interpreted and implemented to achieve
the following paramount objectives:
<bullet> Preservation of human life;
<bullet> Preventing the further introduction, transmission, and
spread of the virus that causes COVID-19 into the United States,
including the Omicron virus variant and other new virus variants;
<bullet> Preserving the health and safety of crew members,
passengers, airport personnel, and communities; and
<bullet> Preserving hospital, healthcare, and emergency response
resources within the United States.
Definitions
Aircraft shall have the same definition as under 49 U.S.C.
40102(a)(6). ``Aircraft'' includes, but is not limited to, commercial,
general aviation, and private aircraft destined for the United States
from a foreign country.
Aircraft Operator means an individual or organization causing or
authorizing the operation of an aircraft.
Airline shall have the same definition as under 42 CFR 71.1(b).
Attest/Attestation means having completed the attestation in
Attachment A.\4\ Such attestation may be completed in paper or digital
form. The attestation
[[Page 69258]]
is a statement, writing, entry, or other representation under 18 U.S.C.
1001.\5\
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\4\ CDC has provided a combined passenger disclosure and
attestation that fulfills the requirements of CDC Orders:
Requirements for Negative Pre-departure COVID-19 Test Result or
Documentation of Recovery from COVID-19 and Testing for All Airline
or Other Aircraft Passengers Arriving into the United States from
Any Foreign Country and Order Implementing Presidential Proclamation
on Advancing the Safe Resumption of Global Travel During the COVID-
19 Pandemic.
\5\ CDC encourages airlines and aircraft operators to
incorporate the attestation into paperless check-in processes. An
airline or aircraft operator may use a third party (including a
third-party application) to collect attestations, including to
provide translations. However, an airline or aircraft operator has
sole legal responsibility to provide and collect attestations, to
ensure the accuracy of any translation, and to comply with all other
obligations under this Order. An airline or aircraft operator is
responsible for any failure of a third party to comply with this
Order. An airline or aircraft operator may not shift any legal
responsibility to a third party.
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Documentation of Recovery means paper or digital documentation of
having recovered from COVID-19 in the form of a positive SARS-CoV-2
viral test result and a letter from a licensed healthcare provider or
public health official stating that the person has been cleared for
travel (i.e., has recovered).\6\ \7\ The viral test must have been
conducted on a specimen collected no more than 90 calendar days before
the departure of the flight, or at such other intervals as specified in
CDC guidance.
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\6\ Healthcare providers and public health officials should
follow CDC guidance in clearing patients for travel to the United
States. Applicable guidance is available at <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html</a>.
\7\ A letter from a healthcare provider or a public health
official that clears the person to end isolation (e.g., to return to
work or school), can also be used to show that the person has been
cleared to travel, even if travel is not specifically mentioned in
the letter.
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Foreign country means anywhere that is not a state, territory, or
possession of the United States.
Qualifying Test means a negative result on a SARS-CoV-2 viral test
that was conducted on a specimen collected no more than 1 calendar day
before the flight's departure from a foreign country to the United
States.
United States has the same definition as ``United States'' in 42
CFR 71.1(b), meaning ``the 50 States, District of Columbia, and the
territories (also known as possessions) of the United States, including
American Samoa, Guam, the Northern Mariana Islands, the Commonwealth of
Puerto Rico, and the U.S. Virgin Islands.''
Viral Test means a viral detection test for current infection
(i.e., a nucleic acid amplification test [NAAT] or a viral antigen
test) cleared, approved, or issued an emergency use authorization (EUA)
by the U.S. Food and Drug Administration, or granted marketing
authorization by the relevant national authority, for the detection of
SARS-CoV-2, performed in accordance with the approval/clearance/EUA/
marketing authorization.
Exemptions
The following categories of individuals and organizations are
exempt from the requirements of this Amended Order:
<bullet> Crew members of airlines or other aircraft operators if
they follow industry standard protocols for the prevention of COVID-19
as set forth in relevant Safety Alerts for Operators (SAFOs) issued by
the Federal Aviation Administration (FAA).\8\
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\8\ Airlines, aircraft operators, and their crew members may
follow stricter protocols for crew and passenger health, including
testing protocols. SAFO 20009, COVID-19: Updated Interim
Occupational Health and Safety Guidance for Air Carriers and Crews,
available at <a href="https://www.faa.gov/other_visit/aviation_industry/airline_operators/airline_safety/safo/all_safos/media/2020/SAFO20009.pdf">https://www.faa.gov/other_visit/aviation_industry/airline_operators/airline_safety/safo/all_safos/media/2020/SAFO20009.pdf</a>.
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<bullet> Airlines or other aircraft operators transporting
passengers with COVID-19 pursuant to CDC authorization and in
accordance with CDC guidance.\9\
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\9\ Interim Guidance for Transporting or Arranging
Transportation by Air into, from, or within the United States of
People with COVID-19 or COVID-19 Exposure, available at <a href="https://www.cdc.gov/quarantine/interim-guidance-transporting.html">https://www.cdc.gov/quarantine/interim-guidance-transporting.html</a>.
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<bullet> U.S. federal law enforcement personnel on official orders
who are traveling for the purpose of carrying out a law enforcement
function, provided they are covered under an occupational health and
safety program that takes measures to ensure personnel are not
symptomatic or otherwise at increased risk of spreading COVID-19 during
travel. Those traveling for training or other business purposes remain
subject to the requirements of this Order.
<bullet> U.S. military personnel, including civilian employees,
dependents, contractors, and other U.S. government employees when
traveling on U.S. military assets (including whole aircraft charter
operators), if such individuals are under competent military or U.S.
government travel orders and observing U.S. Department of Defense
guidance to prevent the transmission of COVID-19 as set forth in Force
Protection Guidance Supplement 20--Department of Defense Guidance for
Personnel Traveling During the Coronavirus Disease 2019 Pandemic (April
12, 2021) including its testing guidance.\10\
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\10\ Force Protection Guidance Supplement 20--Department of
Defense Guidance for Personnel Traveling During the Coronavirus
Disease 2019 Pandemic, available at <a href="https://media.defense.gov/2021/Apr/16/2002622876/-1/-1/1/MEMORANDUM-FOR-FORCE-HEALTH-PROTECTION-GUIDANCE-SUPPLEMENT%2020-DEPARTMENT-OF-DEFENSE-GUIDANCE-FOR-PERSONNEL-TRAVELING-DURING-THE-CORONAVIRUS-DISEASE-2019-PANDEMIC.PDF">https://media.defense.gov/2021/Apr/16/2002622876/-1/-1/1/MEMORANDUM-FOR-FORCE-HEALTH-PROTECTION-GUIDANCE-SUPPLEMENT%2020-DEPARTMENT-OF-DEFENSE-GUIDANCE-FOR-PERSONNEL-TRAVELING-DURING-THE-CORONAVIRUS-DISEASE-2019-PANDEMIC.PDF</a>.
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<bullet> Individuals and organizations for which the issuance of a
humanitarian exemption is necessary based on both: (1) Exigent
circumstances where emergency travel is required to preserve health and
safety (e.g., emergency medical evacuations); and (2) where pre-
departure testing cannot be accessed or completed before travel because
of exigent circumstances.
Background
A. COVID-19 Pandemic
Since January 2020, the respiratory disease known as ``COVID-19,''
caused by a novel coronavirus (SARS-CoV-2), has spread globally,
including cases reported in all 50 states within the United States,
plus the District of Columbia and all U.S. territories. As of December
02, 2021, there have been over 262,000,000 million cases of COVID-19
globally, resulting in over 5,200,000 deaths.\11\ In the United States,
more than 48,000,000 cases have been identified, and over 775,000
deaths attributed to the disease.
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\11\ <a href="https://covid19.who.int/">https://covid19.who.int/</a>.
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SARS-CoV-2 spreads mainly from person-to-person through respiratory
fluids released during exhalation, such as when an infected person
coughs, sneezes, or talks. Exposure to these respiratory fluids occurs
in three principal ways: (1) Inhalation of very fine respiratory
droplets and aerosol particles; (2) deposition of respiratory droplets
and particles on exposed mucous membranes in the mouth, nose, or eye by
direct splashes and sprays; and (3) touching mucous membranes with
hands that have been soiled either directly by virus-containing
respiratory fluids or indirectly by touching surfaces with virus on
them.\12\ \13\ Spread is more likely when people are in close contact
with one another (within about 6 feet), especially in crowded or poorly
ventilated indoor settings. Persons who are not fully vaccinated,
including those with asymptomatic or pre-symptomatic infections, are
significant contributors to community SARS-CoV-2 transmission and
occurrence of COVID-19.\14\ \15\
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\12\ Scientific Brief: SARS-CoV-2 Transmission, Centers for
Disease Control and Prevention (May 7, 2021), <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/sars-cov-2-transmission.html">https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/sars-cov-2-transmission.html</a>.
\13\ Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission
for Indoor Community Environments, Centers for Disease Control and
Prevention (Apr. 5, 2021), <a href="https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html">https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html</a>.
\14\ Moghadas SM, Fitzpatrick MC, Sah P, et al. The implications
of silent transmission for the control of COVID-19 outbreaks. Proc
Natl Acad Sci U S A. 2020;117(30):17513-17515.10.1073/
pnas.2008373117, available at <a href="https://www.ncbi.nlm.nih.gov/pubmed/32632012">https://www.ncbi.nlm.nih.gov/pubmed/32632012</a>.
\15\ Johansson MA, Quandelacy TM, Kada S, et al. SARS-CoV-2
Transmission from People Without COVID-19 Symptoms. Johansson MA, et
al. JAMA Netw Open. 2021 January4;4(1):e2035057. doi: 10.1001/
jamanetworkopen.2020.35057.
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[[Page 69259]]
Among adults, the risk for severe illness from COVID-19 increases
with age, with older adults at highest risk.\16\ Severe illness means
that persons with COVID-19 may require hospitalization, intensive care,
or a ventilator to help them breathe. People of any age with certain
underlying medical conditions (e.g., cancer, obesity, serious heart
conditions, diabetes, conditions that weaken the immune system) are at
increased risk for severe illness from COVID-19.\17\
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\16\ CDC. COVID-19 Risks and Vaccine Information for Older
Adults <a href="https://www.cdc.gov/aging/covid19/covid19-older-adults.html">https://www.cdc.gov/aging/covid19/covid19-older-adults.html</a>.
\17\ People with Certain Medical Conditions <a href="https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html">https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html</a>.
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B. Emergence of Variants of Concern: Omicron
New variants of SARS-CoV-2 have emerged globally, several of which
have been broadly classified as ``variants of concern.'' Some variants
are more transmissible, even among those who are vaccinated, and some
may cause more severe disease, which can lead to more hospitalizations
and deaths among infected individuals.\18\ Furthermore, recent findings
suggest that antibodies generated during previous infection or
vaccination may have a reduced ability to neutralize some variants,
resulting in reduced effectiveness of treatments or vaccines, or
increased diagnostic detection failures.\19\ The emergence of variants
that substantially decrease the effectiveness of available vaccines
against severe or deadly disease is a primary public health concern.
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\18\ 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: <a href="http://dx.doi.org/10.15585/mmwr.mm7028e2">http://dx.doi.org/10.15585/mmwr.mm7028e2</a>
(describing a B.1.617.2 (Delta) Variant COVID-19 outbreak associated
with a gymnastics facility and finding that the Delta variant is
highly transmissible in indoor sports settings and households, which
might lead to increased incidence rates).
\19\ SARS-CoV-2 Variant Classifications and Definitions, Centers
for Disease Control and Prevention, <a href="https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html#Concern">https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html#Concern</a>.
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On November 24, 2021, the Republic of South Africa informed the
World Health Organization (WHO) of a new variant of SARS-CoV-2, the
virus that causes COVID-19, that was detected in that country. On
November 26, 2021, WHO designated the variant B.1.1.529 as a variant of
concern and named it Omicron.\20\ This decision was based on the
evidence presented to the Technical Advisory Group on SARS-CoV-2 Virus
Evolution (TAG-VE) which is a group of independent experts charged with
assessing the evolution of SARS-CoV-2 and examining if specific
mutations and combinations of mutations may alter how the virus spreads
and whether it may cause more severe illness. The evidence presented to
the TAG-VE noted that Omicron has several mutations that may have an
impact on how easily it spreads or the severity of illness it
causes.\21\
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\20\ <a href="https://www.who.int/news/item/26-11-2021-classification-of-omicron-">https://www.who.int/news/item/26-11-2021-classification-of-omicron-</a>(b.1.1.529)-sars-cov-2-variant-of-concern.
\21\ <a href="https://www.who.int/news/item/28-11-2021-update-on-omicron">https://www.who.int/news/item/28-11-2021-update-on-omicron</a>.
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Currently, there are no data available to assess the ability of
sera from vaccinated persons or those with previous SARS-CoV-2
infection to neutralize the Omicron variant. The spike protein is the
primary target of vaccine-induced immunity. The Omicron variant
contains more changes in the spike protein than have been observed in
other variants. Based on the number of substitutions, the location of
these substitutions, and data from other variants with similar spike
protein substitutions, significant reductions in neutralizing activity
of sera from vaccinated or previously infected individuals, which may
indicate reduced protection from infection, are anticipated.\22\
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\22\ Science Brief: Omicron (B.1.1.529) Variant, Centers for
Disease Control and Prevention, <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/scientific-brief-omicron-variant.html">https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/scientific-brief-omicron-variant.html</a>.
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At the present time, WHO and CDC are coordinating with many
researchers around the world to better understand the Omicron variant.
Studies include assessments of transmissibility, severity of infection
(including symptoms), performance of vaccines and diagnostic tests, and
effectiveness of treatments. CDC and other federal agencies are working
closely with international public health agencies to monitor the
situation closely and are taking steps to enhance surveillance for and
response to the Omicron variant within the United States. Considering
these ongoing studies into the potential danger to public health posed
by this newly identified variant, CDC has determined that proactive
measures must be implemented now to protect the U.S. public health from
the importation, transmission and spread of the emergent Omicron
variant into the United States.
C. Requirement for Pre-Departure Testing Regardless of Vaccination
Status
On November 26, 2021, the President issued a Proclamation
suspending the entry into the United States, of immigrants or
nonimmigrants, of noncitizens who were physically present within
certain Southern African countries during the 14-day period preceding
their entry or attempted entry into the United States.\23\ This
Proclamation was issued under the authority of sections 212(f) and
215(a) of the Immigration and Nationality Act, as codified at sections
1182(f) and 1185(a) of title 8, United States Code (U.S.C.), and 3
U.S.C. 301 based on a determination that entry of certain noncitizens
covered by the Proclamation would be detrimental to the interests of
the United States. The Proclamation directs the Secretary of State, the
Secretary of Transportation, and the Secretary of Homeland Security to
endeavor to ensure that any noncitizen subject to the Proclamation does
not board an aircraft traveling to the United States, to the extent
permitted by law. The Proclamation also states that any individuals
exempt from the suspension may nevertheless be subject to an entry
suspension, limitation, or restriction under Proclamation 10294 of
October 25, 2021.
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\23\ <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/11/26/a-proclamation-on-suspension-of-entry-as-immigrants-and-nonimmigrants-of-certain-additional-persons-who-pose-a-risk-of-transmitting-coronavirus-disease-2019/">https://www.whitehouse.gov/briefing-room/presidential-actions/2021/11/26/a-proclamation-on-suspension-of-entry-as-immigrants-and-nonimmigrants-of-certain-additional-persons-who-pose-a-risk-of-transmitting-coronavirus-disease-2019/</a>.
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As the virus that causes COVID-19 spreads, it has new opportunities
to change (mutate) and become more difficult to control. While it is
known and expected that viruses change through mutation leading to the
emergence of new variants, the emergent Omicron variant is particularly
concerning and of critical significance for this Amended Order. CDC has
determined that given the rapid spread of the Omicron variant,
including to countries and regions outside of those originally
identified in the November 26 Proclamation, requiring a SARS-CoV-2 test
no more than 1 calendar day before the flight's departure from a
foreign country as specified in this Notice and Amended Order, and
applicable to all passengers regardless of vaccination status or
country of origin (except passengers who present valid Documentation of
Recovery), is necessary to protect the public health of the United
States.
In response to this new variant, the United States Government,
including CDC, reexamined its policies on international travel and
concluded the proactive 1 calendar day testing measure is necessary to
protect the public health and should remain in place until more
information becomes available that may alter or improve the public
health outlook. This Amended Order requires that all passengers,
[[Page 69260]]
regardless of vaccination status or country of origin, except
passengers who present a valid Documentation of Recovery, provide
documentation of a negative SARS-CoV-2 viral test result from a
specimen collected no more than 1 calendar day preceding the departure
of the passenger's originating flight to the United States. While CDC's
previous Amended Order \24\ indicated that ``decreasing the time window
for testing before departure from three days to one day provides
minimal additional public health benefit for fully vaccinated
travelers,'' this statement did not account for the Omicron variant,
which had not yet been identified.
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\24\ <a href="https://www.federalregister.gov/documents/2021/11/05/2021-24388/requirement-for-negative-pre-departure-covid-19-test-result-or-documentation-of-recovery-from">https://www.federalregister.gov/documents/2021/11/05/2021-24388/requirement-for-negative-pre-departure-covid-19-test-result-or-documentation-of-recovery-from</a>.
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At this time, it is unknown what level of protection current
vaccines will provide against this newly emergent mutated variant. To
best protect the health of the United States, unless and until CDC can
confirm that current approved and authorized vaccines provide adequate
protection against the Omicron variant, all passengers--including those
who are fully vaccinated, but excluding passengers who present a valid
Documentation of Recovery--must obtain a viral test on a specimen
collected no more than 1 calendar day before their flight's departure
to meet the requirements of this Amended Order. The one-day time
window, a reduction from the previous 3-day window for fully vaccinated
passengers, will provide less opportunity to develop infection with the
Omicron variant prior to arrival into the United States.
Testing for SARS-CoV-2 infection is a proactive, risk-based
approach that is not dependent on the infecting variant, nor on
vaccination status of the individual. This risk-based testing approach
has been addressed in CDC guidance and the Runway to Recovery guidance
jointly issued by the Departments of Transportation, Homeland Security,
and Health and Human Services.\25\ Most countries now use testing in
some form to monitor risk and control introduction and spread of SARS-
CoV-2.\26\ With case counts and deaths due to COVID-19 continuing to
increase around the globe and the emergence of the new and concerning
Omicron variant, the United States is taking a multi-layered proactive
approach to combating COVID-19, concurrently preventing and slowing the
continued introduction of cases and further spread of the virus within
U.S. communities. CDC acknowledges that pre-departure testing does not
eliminate all risk.
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\25\ Runway to Recovery 1.1, December 21, 2020, available at
<a href="https://www.transportation.gov/briefing-room/runway-recovery-11">https://www.transportation.gov/briefing-room/runway-recovery-11</a>.
\26\ <a href="https://ourworldindata.org/coronavirus-testing#testing-and-contact-tracing-policy">https://ourworldindata.org/coronavirus-testing#testing-and-contact-tracing-policy</a>.
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D. Statement of Good Cause Under the Administrative Procedure Act
(``APA'')
To reduce introduction and spread of current and future SARS-CoV-2
variants into the United States at a time when global air travel is
increasing, CDC must take quick and targeted action to help curtail the
introduction and spread of the Omicron variant into the United States.
As of December 2, 2021, WHO has indicated that 23 countries have
reported cases of the Omicron variant, many of which were associated
with international travelers.
This Amended Order is not a rule within the meaning of the
Administrative Procedure Act (``APA'') but rather is an emergency
action taken under the existing authority of 42 U.S.C. 264(a) and 42
CFR 71.20 and 71.31(b), which were promulgated in accordance with the
APA after full notice-and-comment rulemaking and a delay in effective
date. In the event that this Amended Order qualifies as a new rule
under the APA, notice and comment and a delay in effective date are not
required because there is good cause to dispense with prior public
notice and comment and a delay in effective date. See 5 U.S.C.
553(b)(B), (d)(3).
Considering the rapid and unpredictable developments in the public
health emergency caused by COVID-19, including the recently identified
emergent Omicron variant, 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 Amended Order. Further delay could
increase risk of transmission and importation of additional undetected
cases of SARS-CoV-2 Omicron variant or other emerging variants through
passengers.
Similarly, the Office of Information and Regulatory Affairs has
determined that if this Amended Order were a rule, it would be a major
rule under Subtitle E of the Small Business Regulatory Enforcement
Fairness Act of 1996 (the Congressional Review Act), 5 U.S.C. 804(2),
but there would not be a delay in its effective date as the agency has
determined that there would be good cause to make the requirements
herein effective immediately under the APA, 5 U.S.C. 808(2).
This Amended Order is also an economically significant regulatory
action under Executive Order 12866 and has therefore been reviewed by
the Office of Information and Regulatory Affairs of the Office of
Management and Budget.
If any provision of this Amended 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.
Pursuant to 5 U.S.C. 553(b)(B), and for the reasons stated above, I
hereby conclude that notice-and-comment rulemaking would defeat the
purpose of the Amended Order and endanger the public health, and is,
therefore, impracticable and contrary to the public interest. For the
same reasons, I have determined, consistent with 5 U.S.C. 553(d)(3),
that there is good cause to make this Amended Order effective
immediately upon filing at the Office of the Federal Register.
Action
For the reasons outlined above, I hereby determine that passengers
covered by this Amended Order are at risk of transmitting SARS-CoV-2
virus, including the emergent Omicron variant and other virus variants.
Accordingly, requiring passengers to demonstrate pre-departure either a
negative COVID-19 test result or recovery from COVID-19 after previous
SARS-CoV-2 infection in the past 90 days is necessary to reduce the
risk of transmission of the SARS-CoV-2 virus, including the Omicron
variant and other virus variants, and to protect the health of fellow
passengers, aircraft crew, and U.S. communities. This Amended Order
shall remain effective until either the expiration of the Secretary of
HHS' declaration that COVID-19 constitutes a public health emergency,
or I determine that based on specific public health or other
considerations that continuation of this Order is no longer necessary
to prevent the further introduction, transmission, and spread of COVID-
19 into the United States, whichever occurs first. Upon determining
that continuation of this Order is no longer necessary to prevent the
further introduction, transmission, and spread of COVID-19 into the
United States, I will publish a notice in the Federal Register
terminating this Order. I retain the authority to modify or terminate
the Order, or its implementation, at any time as needed to protect
public health.
[[Page 69261]]
1. Requirements for Airlines & Other Aircraft Operators
Any airline or other aircraft operator with passengers arriving
into the United States from a foreign country, shall:
A. Confirm that every passenger--2 years or older--onboard the
aircraft has paper or digital documentation reflecting a Qualifying
Test or Documentation of Recovery.
(1) Requirements for a Qualifying Test include:
a. Documentation of a negative SARS-CoV-2 viral test result from a
specimen collected no more than 1 calendar day preceding the
passenger's flight to the United States. The negative SARS-CoV-2 viral
test result must include:
i. personal identifiers (e.g., name and date of birth) on the
negative test result that match the personal identifiers on the
passenger's passport or other travel documents;
ii. a specimen collection date indicating that the specimen was
collected no more than 1 calendar day before the flight's departure (or
first flight in a series of connections booked on the same itinerary);
iii. the type of viral test indicating it is a NAAT or antigen
test;
iv. a test result that states ``NEGATIVE,'' ``SARS-CoV-2 RNA NOT
DETECTED,'' ``SARS-CoV-2 ANTIGEN NOT DETECTED,'' or ``COVID-19 NOT
DETECTED,'' or other indication that SARS-CoV-2 was not detected in the
individual's specimen. A test marked ``invalid'' is not acceptable; and
v. information about the entity issuing the result (e.g.,
laboratory, healthcare entity, or telehealth service), such as the name
and contact information.
(2) Requirements for Documentation of Recovery include:
a. Documentation of a positive SARS-CoV-2 viral test result from a
specimen collected no more than 90 calendar days preceding the
passenger's scheduled flight to the United States.\27\ The positive
SARS-CoV-2 viral test result must include:
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\27\ Interim Guidance on Ending Isolation and Precautions for
Adults with COVID-19 <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html</a>.
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i. Personal identifiers (e.g., name and date of birth) on the
positive test result match the personal identifiers on the passenger's
passport or other travel documents;
ii. a specimen collection date indicating that the specimen was
collected no more than 90 calendar days before the flight's departure;
iii. information that the test performed was a viral test
indicating it is a NAAT or antigen test;
iv. a test result that states ``POSITIVE,'' ``SARS-CoV-2 RNA
DETECTED,'' ``SARS-CoV-2 ANTIGEN DETECTED,'' or ``COVID-19 DETECTED,''
or other indication that SARS-CoV-2 was detected in the individual's
specimen. A test marked ``invalid'' is not acceptable; and
v. information about the entity issuing the result (e.g.,
laboratory, healthcare entity, or telehealth service), such as the name
and contact information.
b. A signed letter from a licensed healthcare provider or a public
health official stating that the passenger has been cleared for
travel.<SUP>28 29</SUP> The letter must have personal identifiers
(e.g., name and date of birth) that match the personal identifiers on
the passenger's passport or other travel documents. The letter must be
signed and dated on official letterhead that contains the name,
address, and phone number of the healthcare provider or public health
official who signed the letter.
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\28\ Healthcare providers and public health officials should
follow CDC guidance in clearing patients for travel to the United
States. Applicable guidance is available at <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html</a>.
\29\ A letter from a healthcare provider or a public health
official that clears the person to end isolation, e.g., to return to
work or school, can also be used to show that the person has been
cleared to travel, even if travel is not specifically mentioned in
the letter.
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B. Confirm that each passenger has attested to having received a
negative result for a Qualifying Test or having tested positive for
SARS-CoV-2 on a specimen collected no more than 90 calendar days before
the flight and been cleared to travel. Airlines or other aircraft
operators must retain a copy of each passenger attestation for 2 years.
The attestation is attached to this order as Attachment A.
C. Not board any passenger without confirming the documentation as
set forth in section 1.A and 1.B.
Any airline or other aircraft operator that fails to comply with
section 1, ``Requirements for Airlines & Other Aircraft Operators,''
may be subject to criminal penalties under, inter alia, 42 U.S.C. 271
and 42 CFR 71.2, in conjunction with 18 U.S.C. 3559 and 3571.
2. Requirements for Aircraft Passengers
Any aircraft passenger \30\ departing from any foreign country with
a destination in the United States shall--
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\30\ A parent or other authorized individual may present the
required documentation on behalf of a passenger 2-17 years of age.
An authorized individual may act on behalf of any passenger who is
unable to act on their own behalf (e.g., by reason of age, or
physical or mental impairment).
---------------------------------------------------------------------------
A. Present paper or digital documentation reflecting one of the
following:
(1) A negative Qualifying Test that has a specimen collection date
indicating that the specimen was collected no more than 1 calendar day
before the flight's departure (or first flight in a series of
connections booked on the same itinerary); or
(2) Documentation of Recovery from COVID-19 that includes a
positive SARS-CoV-2 viral test result conducted on a specimen collected
no more than 90 calendar days before the flight and a letter from a
licensed healthcare provider or public health official stating that the
passenger has been cleared for travel.<SUP>31 32</SUP>
---------------------------------------------------------------------------
\31\ A letter from a healthcare provider or a public health
official that clears the person to end isolation, e.g., to return to
work or school, can also be used to show that the person has been
cleared to travel, even if travel is not specifically mentioned in
the letter.
\32\ Healthcare providers and public health officials should
follow CDC guidance in clearing patients for travel to the United
States. Applicable guidance is available at <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html</a>.
---------------------------------------------------------------------------
B. Provide the attestation to the airline or other aircraft
operator, of:
(1) Having received a negative result for the Qualifying Test; or
(2) having tested positive for SARS-CoV-2 on a specimen collected
no more than 90 calendar days before the flight and been cleared to
travel.
The attestation is attached to this order as Attachment A. Unless
otherwise permitted by law, a parent or other authorized individual may
present the required documentation on behalf of a passenger 2-17 years
of age. An authorized individual may act on behalf of any passenger who
is unable to act on their own behalf (e.g., by reason of age, or
physical or mental impairment).
C. Retain a copy of the applicable documentation listed in part A
of this section and produce such documentation upon request to any U.S.
government official or a cooperating state or local public health
authority after arrival into the United States.
Any passenger who fails to comply with the requirements of section
2, ``Requirements for Aircraft Passengers,'' may be subject to criminal
penalties under, inter alia, 42 U.S.C. 271 and 42 CFR 71.2, in
conjunction with 18 U.S.C. 3559 and 3571. Willfully giving false or
misleading information to the government may result in criminal
penalties under, inter alia, 18 U.S.C. 1001.
This Amended Order shall be enforceable through the provisions of
18 U.S.C. 3559, 3571; 42 U.S.C. 243, 268, 271; and 42 CFR 71.2.
[[Page 69262]]
As the pandemic continues to rapidly evolve and more scientific
data becomes available regarding the emergent Omicron variant and/or
the effectiveness of COVID-19 vaccines related to currently circulating
variants, CDC may exercise its enforcement discretion to adjust the
scope of accepted pre-departure testing requirements to allow
passengers and airline and aircraft operators greater flexibility
regarding the requirements of this Amended Order or to align with
current CDC guidance. Such exercises of enforcement discretion will be
announced on CDC's website and the Amended Order will be further
amended as soon as practicable through an updated publication in the
Federal Register.
Effective Date
This Amended Order shall enter into effect for flights departing at
or after 12:01 a.m. EST (5:01 a.m. GMT) on December 6, 2021, and will
remain in effect unless modified or rescinded based on specific public
health or other considerations, or until the Secretary of Health and
Human Services rescinds the determination under section 319 of the
Public Health Service Act (42 U.S.C. 247d) that a public health
emergency exists with respect to COVID-19.
BILLING CODE 4163-18-P
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[[Page 69284]]
Authority
The authority for this Amended Order is Section 361 of the Public
Health Service Act (42 U.S.C. 264) and 42 CFR 71.20 & 71.31(b).
Sherri Berger,
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2021-26603 Filed 12-3-21; 4:15 pm]
BILLING CODE 4163-18-C
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</html>Indexed from Federal Register on December 7, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.