Federal Register, Volume 85 Issue 177 (Friday, September 11, 2020)

[Federal Register Volume 85, Number 177 (Friday, September 11, 2020)]
[Rules and Regulations]
[Pages 56424-56460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20036]

[[Page 56423]]

Vol. 85

Friday,

No. 177

September 11, 2020

Part IV

Department of Health and Human Services

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42 Part 71

Control of Communicable Diseases; Foreign Quarantine: Suspension of the
Right To Introduce and Prohibition of Introduction of Persons Into
United States From Designated Foreign Countries or Places for Public
Health Purposes; Final Rule

Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 /
Rules and Regulations

[[Page 56424]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 71

[Docket No. CDC-2020-0033]
RIN 0920-AA76

Control of Communicable Diseases; Foreign Quarantine: Suspension
of the Right To Introduce and Prohibition of Introduction of Persons
Into United States From Designated Foreign Countries or Places for
Public Health Purposes

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

ACTION: Final rule.

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SUMMARY: The Department of Health and Human Services (HHS) issues this
final rule to amend the Foreign Quarantine Regulations administered by
the Centers for Disease Control and Prevention (CDC). This final rule
provides a procedure for the CDC Director to suspend the right to
introduce and prohibit introduction, in whole or in part, of persons
from such foreign countries or places as the Director shall designate
in order to avert the danger of the introduction of a quarantinable
communicable disease into the United States, and for such period of
time as the Director may deem necessary for such purpose.

DATES: This final rule is effective on October 13, 2020.

FOR FURTHER INFORMATION CONTACT: Nina Witkofsky, Acting Chief of Staff,
Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS
H21-10, Atlanta, GA 30329. Telephone: 404-639-7000; email:
cdcregulations@cdc.gov.

SUPPLEMENTARY INFORMATION: This final rule is organized as follows:

Table of Contents

I. Summary
II. Policy Rationale and Factual Basis for Final Rule
A. HHS/CDC's Experience Is That Travel and Migration Can Impact
the Spread of Quarantinable Communicable Diseases
B. The Response of the United States to the Coronavirus Disease
2019 (COVID-19) Pandemic Shows That This Final Rule Is in the
Interest of U.S. Public Health
1. COVID-19 Is a Highly Contagious Disease That Threatens
Vulnerable Populations
2. The United States Has Taken Broad Actions To Slow the
Introduction of COVID-19 Into the Country and Protect Vulnerable
Populations
a. Immigration and Nationality Act Section 212(f) Proclamations
b. Quarantine and Isolation of Repatriates and Cruise Ship
Travelers
c. The CDC No Sail Order for Cruise Ships
d. Travel Restrictions at the Land Ports of Entry Along the
United States-Canada and United States-Mexico Borders
e. The CDC Order on Covered Aliens
3. Other Jurisdictions Have Taken Similar Actions To Slow the
Introduction of COVID-19, Which Underscores Why This Final Rule Is
in the Interest of U.S. Public Health
a. The European Union and Schengen Area
b. Australia and New Zealand
c. Canada
C. This Rulemaking Finalizes Procedures Necessary for HHS/CDC's
Continued Protection of U.S. Public Health From the COVID-19
Pandemic and Future Threats
III. Statutory Authority
A. History of the U.S. Public Health Laws
B. Other Statutory Authorities Relevant to This Rulemaking
IV. Provisions of New Section 71.40 and Changes From Interim Final
Rule
A. Section 71.40(a)
B. Section 71.40(b)
1. 71.40(b)(1): ``Introduction Into the United States''
2. 71.40(b)(2): ``Prohibit, in Whole or in Part, the
Introduction Into the United States of Persons''
3. 71.40(b)(3): ``Serious Danger of the Introduction of Such
Quarantinable Communicable Disease Into the United States''
4. 71.40(b)(4): ``Place''
5. 71.40(b)(5): ``Suspension of the Right to Introduce''
C. Section 71.40(c)
D. Section 71.40(d)
E. Section 71.40(e)
F. Section 71.40(f)
G. Sections 71.40(g)
V. Responses to Public Comments
VI. Alternatives Considered
VII. Regulatory Impact Analysis
A. Unfunded Mandates Reform Act
B. National Environmental Policy Act (NEPA)
C. Executive Order 12988: Civil Justice Reform
D. Executive Order 13132: Federalism
E. Plain Language Act of 2010
F. Congressional Review Act and Administrative Procedure Act
G. Executive Orders 12866 and 13563 and Regulatory Flexibility
Act
H. Assessment of Federal Regulation and Policies on Families
I. Paperwork Reduction Act of 1995
J. Regulatory Reform Analysis Under Executive Order 13771

I. Summary

This final rule is effective on October 13, 2020, unless the
interim final rule (IFR) entitled Control of Communicable Diseases;
Foreign Quarantine: Suspension of Introduction of Persons Into United
States From Designated Foreign Countries or Places for Public Health
Purposes (85 FR 16559) (Mar. 24, 2020), or the Centers for Disease
Control & Prevention's (CDC) Order on covered aliens, Control of
Communicable Diseases; Foreign Quarantine: Suspension of Introduction
of Persons into United States from Designated Foreign Countries or
Places for Public Health Purposes, (85 FR 16559) (Mar. 24, 2020), as
amended, is vacated or enjoined by a court, in which case, the
Secretary will publish a document in the Federal Register announcing an
updated effective date for this rule.
The U.S. Department of Health and Human Services (HHS) finalizes
the interim final rule (IFR) entitled Control of Communicable Diseases;
Foreign Quarantine: Suspension of Introduction of Persons Into United
States From Designated Foreign Countries or Places for Public Health
Purposes (85 FR 16559) published on March 24, 2020, to implement
section 362 of the Public Health Service (PHS) Act, 42 U.S.C. 265.
HHS/CDC implements section 362 because the Surgeon General's
statutory authority under section 362 passed by operation of law to the
Secretary of Health and Human Services (HHS Secretary),\1\ who
delegated his or her statutory authority to the CDC Director
(Director).
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\1\ The statute assigns this authority to the Surgeon General of
the Public Health Service. Nevertheless, Reorganization Plan No. 3
of 1966 abolished the Office of the Surgeon General and transferred
all statutory powers and functions of the Surgeon General and other
officers of the Public Health Service and of all agencies of or in
the Public Health Service to the Secretary of Health, Education, and
Welfare, now the Secretary of Health and Human Services, 31 FR 8855-
01, 80 Stat. 1610 (June 25, 1966), see also Public Law 96-88, Sec.
509(b), October 17, 1979, 93 Stat. 695 (codified at 20 U.S.C. Sec.
3508(b)). Sections 361 through 369 of the PHS Act (42 U.S.C. Sec.'s
264-272) have been delegated from the HHS Secretary to the CDC
Director. References in the PHS Act to the Surgeon General are to be
read in light of the transfer of statutory functions and re-
designation. Although the Office of the Surgeon General was re-
established in 1987, the Secretary of HHS has retained the
authorities previously held by the Surgeon General.
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Through this rulemaking, HHS/CDC establishes final regulations
under which the Director may suspend the right to introduce and
prohibit, in whole or in part, the introduction of persons into the
United States for such period of time as the Director may deem
necessary to avert the serious danger of the introduction of a
quarantinable communicable disease into the United States. This
rulemaking does not address the ``property'' prong of the statute
because existing regulations already do so. The final rule uses the
term ``quarantinable communicable disease'' instead of ``communicable
disease'' to specify that this regulation is only meant to apply to
communicable diseases that are included on the

[[Page 56425]]

Federal list of quarantinable communicable diseases, which is a subset
of ``communicable diseases'' specified by Executive Order of the
President.\2\ Specifically, this final rule permits the Director to
prohibit, in whole or in part, the introduction into the United States
of persons from designated foreign countries (or one or more political
subdivisions or regions thereof) or places, only for such period of
time that the Director deems necessary to avert the serious danger of
the introduction of a quarantinable communicable disease, by issuing an
Order in which the Director determines that:
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\2\ Exec. Order 13295 (Apr. 4, 2003), as amended by Exec. Order
13375 (Apr. 1, 2005) and Exec. Order 13674 (July 31, 2014) (the
current list of diseases includes cholera, diphtheria, infectious
tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic
fevers (including Lassa, Marburg, Ebola, Crimean-Congo, South
American, and others not yet isolated or named), severe acute
respiratory syndromes (including Middle East Respiratory Syndrome
and COVID-19), and influenza caused by novel or reemergent influenza
viruses that are causing, or have the potential to cause a
pandemic).
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(1) By reason of the existence of any quarantinable communicable
disease in a foreign country (or one or more political subdivisions or
regions thereof) or place there is serious danger of the introduction
of such quarantinable communicable disease into the United States; and
(2) This danger is so increased by the introduction of persons from
such country (or one or more political subdivisions or regions thereof)
or place that a suspension of the right to introduce such persons into
the United States is required in the interest of public health.
The final rule defines key statutory and regulatory language to
clarify when and under what circumstances the Director may exercise the
section 362 authority by issuing an administrative Order. The
regulatory text of this final rule sets forth only definitions and
procedures. No action can or will be taken under this final rule absent
an administrative Order issued by the Director.
First, the final rule defines ``introduction into the United
States'' of persons to mean the movement of a person from a foreign
country (or one or more political subdivisions or regions thereof) or
place, or series of foreign countries or places, into the United States
so as to bring the person into contact with persons or property in the
United States, in a manner that the Director determines to present a
risk of transmission of a quarantinable communicable disease to
persons, or a risk of contamination of property with a quarantinable
communicable disease, even if the quarantinable communicable disease
has already been introduced, transmitted, or is spreading within the
United States.
This definition clarifies that ``introduction'' does not
necessarily conclude the instant that a person first steps onto U.S.
soil. The introduction of a person into the United States can occur not
only when a person first steps onto U.S. soil, but also when a person
on U.S. soil moves further into the United States, and begins to come
into contact with persons or property in ways that increase the risk of
transmitting the quarantinable communicable disease. A person's
presence in the United States may still constitute a violation of a
section 362 Order regardless of the length of time the person has been
present in the country in direct contravention of the Order.
The final rule next defines ``[p]rohibit, in whole or in part, the
introduction into the United States of persons'' to mean ``to prevent
the introduction of persons into the United States by suspending any
right to introduce into the United States, physically stopping or
restricting movement into the United States, or physically expelling
from the United States some or all of the persons.'' This is consistent
with the text and legislative history of the statute. Congress sought
to provide the Executive Branch, to the maximum extent allowed under
the Constitution, the power to prevent the introduction of communicable
diseases into the country. The power to expel is critical to upholding
the intent of Congress in situations where neither HHS/CDC, nor other
Federal agencies, nor state or local governments have the facilities
and personnel necessary to quarantine, isolate, or conditionally
release the number of persons who would otherwise increase the serious
danger of the introduction of the communicable disease into the United
States. In those situations, the rapid expulsion of persons from the
United States may be the most effective public health measure that HHS/
CDC can implement within the finite resource of HHS/CDC and its
Federal, State, and local partners. Absent the power to expel, the
problem that Congress sought to avoid--the introduction of communicable
diseases--may occur despite the best efforts of HHS/CDC.
The final rule defines ``serious danger of the introduction of such
quarantinable communicable disease into the United States'' as ``the
probable introduction of one or more persons capable of transmitting
the quarantinable communicable disease into the United States, even if
persons or property in the United States are already infected or
contaminated with the quarantinable communicable disease.'' The final
rule recognizes that people may be capable of transmitting a
quarantinable communicable disease without actually knowing it, and
their movement may result in the transmission of the disease to others.
This regulatory definition clarifies that, even if persons in the
United States are already infected with a quarantinable communicable
disease, the probable introduction of additional persons capable of
transmitting the disease in the same or different localities
nevertheless presents a serious danger of the introduction of the
disease into the United States. This clarification is informed by HHS/
CDC's experience during the coronavirus disease 2019 (COVID-19)
pandemic and the Federal government's past use of section 362 and its
predecessor statute. Because COVID-19 meets the definition for a severe
acute respiratory syndrome, it is included in those quarantinable
communicable diseases identified by Executive Order.
This final rule defines ``place'' to mean ``any location specified
by the Director, including any carrier, as that term is defined in 42
CFR 71.1, whatever the carrier's flag, registry, or country of
origin.'' This definition clarifies that when HHS refers to ``place''
in this final rule, it refers to territories within or outside of a
country, and also to carriers, regardless of the carrier's flag,
registry, or country of origin. A ``carrier'' is defined in 42 CFR 71.1
to mean ``a ship, aircraft, train, road vehicle, or other means of
transport, including military.''
This final rule defines ``suspension of the right to introduce'' to
mean to cause the temporary cessation of the effect of any law, rule,
decree, or order pursuant to which a person might otherwise have the
right to be introduced or seek introduction into the United States.\3\
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\3\ Aliens who are outside the United States have no right to
entry under either the Constitution or the immigration laws. See,
e.g., 8 U.S.C. Sec. 1225(a)(1) (defining ``applicant for admission''
as an alien ``who arrives in the United States''); Sale v. Haitian
Ctrs. Council, Inc., 509 U.S. 155, 173 (1993) (``the presumption
that Acts of Congress do not ordinarily apply outside our borders
would support an interpretation of [a provision providing for
deportation proceedings] as applying only within United States
territory.''); United States ex. rel Knauff v. Shaugnessy, 338 U.S.
537, 542 (1950) (``At the outset we wish to point out that an alien
who seeks admission to this country may not do so under any claim of
right. Admission of aliens to the United States is a privilege
granted by the sovereign United States Government. Such privilege is
granted to an alien only upon such terms as the United States shall
prescribe.'').

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[[Page 56426]]

Congress's use of the terms ``suspension'' and ``right to
introduce''--rather than just ``introduce''--means that that section
362 grants the Director the authority to temporarily suspend the effect
of any law, rule, decree, or order by which a person would otherwise
have the right to be introduced or seek introduction into the U.S. The
legislative history indicates that Congress, in enacting section 362's
predecessor, sought to give the Executive Branch the authority to
suspend immigration when required in the interest of public health.
This authority is available only in rare circumstances when ``required
in the interest of the public health.'' 42 U.S.C. 265.
This final rule also sets out the information that the Director
must include in any order issued pursuant to this final rule. The
Director must, as practicable, consult with relevant Federal
departments and agencies and provide them with a copy of any order
before issuing the order, and provide guidance to the affected agencies
regarding implementation of any orders issued pursuant to this final
rule. Any such order must include a statement of the following:
(1) The foreign countries (or one or more political subdivisions or
regions thereof) or places from which the introduction of persons is
being prohibited;
(2) the period of time or circumstances under which the
introduction of any persons or class of persons into the United States
is being prohibited;
(3) the conditions under which that prohibition on introduction
will be effective, in whole or in part, including any relevant
exceptions that the Director determines are appropriate;
(4) the means by which the prohibition will be implemented; and
(5) the serious danger posed by the introduction of the
quarantinable communicable disease in the foreign country or countries
(or one or more political subdivisions or regions thereof) or places
from which the introduction of persons is being prohibited.
The Director may also provide that certain persons are excepted in
an order. For example, the Director may except: aliens whose travel
falls within the scope of section 11 of the United Nations Headquarters
Agreement or who would otherwise be allowed entry into the United
States pursuant to U.S. obligations under applicable international
agreements; diplomatic travelers; U.S. government employees; and those
travelling for humanitarian purposes. The Director may also provide in
an Order that another Federal agency or a state or local government
implementing the order may carry out the exception in the Order under
certain circumstances.

II. Policy Rationale and Factual Basis for Final Rule

This final rule is critical to protecting U.S. public health
because Federal Orders requiring the quarantine,\4\ isolation,\5\ or
conditional release \6\ of persons arriving into the United States from
foreign countries may be inadequate to protect public health from the
serious danger of the introduction into the United States of a
quarantinable communicable disease. Simply put, quarantine, isolation,
and conditional release have practical limitations. Federal quarantine
and isolation permitted under section 361 of the PHS Act--where HHS/CDC
funds and operates residential facilities with 24-hour wrap-around
services for persons arriving into the United States from a foreign
country--may be scalable and effective for hundreds of persons, but not
thousands of them. Even then, Federal quarantine and isolation require
substantial resources and are not sustainable for extended periods of
time. Ordering a conditional release or, alternatively, recommending
that individuals self-isolate or self-quarantine at home or elsewhere
without direct public health supervision, requires fewer government
resources and can be scalable and sustainable for larger populations.
Conditional release orders and recommendations to self-isolate or self-
quarantine may be effective for persons who have a home (or similar
residence) in the United States and can provide complete and accurate
contact information for use in monitoring and contact tracing by State
or local public health officials. But such public health measures may
be ineffective for persons who lack a home (or similar residence) in
the United States or contact information that is usable by public
health authorities.
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\4\ Under 42 CFR Sec. 71.1(b), quarantine means the separation
of an individual or group reasonably believed to have been exposed
to a quarantinable communicable disease, but who is/are not yet ill,
from others who have not been so exposed, to prevent the possible
spread of the quarantinable communicable disease.
\5\ Under 42 CFR Sec. 71.1(b), isolation means the separation of
an individual or group who is reasonably believed to be infected
with a quarantinable communicable disease from those who are healthy
to prevent the spread of the quarantinable communicable disease.
\6\ Under 42 CFR Sec. 71.1(b), conditional release means
surveillance as defined under part 71 and includes public health
supervision through in-person visits by a health official or
designee, telephone, or through any electronic or internet-based
means as determined by the Director.
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The issuance of conditional release orders, or recommendations to
self-isolate or self-quarantine, may also be inadequate if the persons
arriving into the United States must first spend time in congregate
settings--such as on carriers or in certain government facilities. In
congregate settings, travelers infected with a quarantinable
communicable disease (whether asymptomatic or symptomatic) may spread
the disease to other travelers or government personnel or private
sector workers, who may, in turn, spread disease to the domestic
population. In such a scenario, the subsequent separation of the
original, infected traveler would not mitigate the spread of disease
through other individuals who interacted with the traveler in the
congregate setting.
Congress provided the Secretary an additional tool for protecting
public health when a communicable disease exists in a foreign country
and there is a serious danger of the introduction of the disease into
the United States under section 362. As the Secretary's delegate, the
Director may exercise his or her section 362 authority to avert the
serious danger of the introduction of the disease by issuing an order
suspending the right to introduce and prohibiting the introduction of
persons from a foreign country or place. The Director has the
flexibility to prohibit the introduction of some persons under section
362, while issuing orders for the quarantine, isolation, or conditional
release of other persons under section 361 of the PHS Act and its
implementing regulations. To achieve the purpose of section 362, the
Director also has the discretion to tailor the exercise of the section
362 authority to the specific danger, which may turn on epidemiological
factors, as well as the time, setting, and geographic location of the
danger. This final rule establishes a flexible procedure for tailoring
the exercise of the section 362 authority in response to the current
COVID-19 pandemic and to address future public health threats.
The policy rationale for this final rule is grounded in HHS/CDC's
experience during the COVID-19 pandemic. When HHS/CDC has acted to
prevent the movement of potentially exposed persons and property into
the United States, as described below, HHS/CDC has slowed the
introduction of COVID-19 into the United States and reduced the
exposure of government personnel

[[Page 56427]]

and private sector workers in congregate settings to COVID-19. HHS/CDC
has also conserved the finite government resources available for the
domestic response to the COVID-19 pandemic.
HHS/CDC's actions regarding the U.S. Department of Homeland
Security's (DHS) U.S. Customs and Border Protection (CBP) facilities at
or near the U.S. borders with Canada and Mexico, which are discussed
more fully below, are one example of how this final rule enables HHS/
CDC to mitigate the serious danger of the introduction of a
quarantinable communicable disease into the United States. COVID-19 is
present in Canada and Mexico, and there is a serious danger that
persons traveling from those countries will introduce COVID-19 into CBP
facilities, and ultimately the interior of the United States. CBP
facilities are not structured or equipped for quarantine, isolation, or
social distancing during a pandemic involving a highly contagious
disease such as COVID-19. In particular, Border Patrol stations were
designed for the purpose of short-term holding in a congregate setting,
and those facilities generally lack the areas needed to quarantine or
isolate aliens for COVID-19. The Director determined that measures such
as quarantine, isolation, and social distancing would be a challenge to
conduct and sustain at CBP facilities, as acknowledged in the CDC
Interim Guidance on Management of Coronavirus Disease 2019 (COVID-19)
in Correctional and Detention Facilities.\7\ He was concerned that
infected aliens in the congregate areas of the CBP facilities might
spread COVID-19 to others in the same areas. Such spread of COVID-19
within CBP facilities might result in CBP personnel needing to self-
quarantine or self-isolate (or worse, cause them to become seriously
ill or die), potentially degrading the ability of CBP to perform all
functions necessary to fulfill its mission, and increasing the strain
on local healthcare systems. The Director mitigated the public health
risks in CBP facilities--and the potential downstream risks to U.S.
public health and national security more broadly--by issuing an Order
under section 362 prohibiting the introduction of certain ``covered
aliens'' into CBP facilities.
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\7\ Interim Guidance on Management of Coronavirus Disease 2019
(COVID-19) in Correctional and Detention Facilities, Ctrs. for
Disease Control and Prevention, https://www.cdc.gov/coronavirus/2019-ncov/community/correction-detention/guidance-correctional-detention.html (last updated Jul. 22, 2020).
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HHS/CDC actions regarding cruise ships are another example of how
preventing the movement of potentially exposed persons into the United
States has slowed the introduction of COVID-19 into the United States.
In early 2020, cruise ships carrying thousands of crew and passengers
were continuing to travel between international ports. As crew and
passengers became infected with COVID-19, disembarkation in major U.S.
port cities presented a danger of introduction of COVID-19 into the
United States. HHS/CDC and other Federal, state, and local agencies
deployed hundreds of personnel to disembark and quarantine or isolate
travelers. This intervention averted the danger presented by those
travelers who entered quarantine or isolation at Federal sites, but it
was not sustainable operationally because of the resources needed to
maintain it. Nor did such efforts mitigate COVID-19 transmission on
cruise ships generally, or the continuing risk of cruise ships
introducing COVID-19 into U.S. ports. HHS/CDC therefore exercised its
authorities under sections 361 and 365 of the PHS Act to issue a No
Sail Order and Suspension of Further Embarkation (85 FR 16628),
published on March 14, 2020,\8\ to ``prevent the spread of disease and
ensure cruise ship passenger and crew health.''
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\8\ This Order was subsequently modified and extended on April
9, 2020 (effective, April 15, 2020) (85 FR 21004, (Apr. 15, 2020))
and July 16, 2020 (85 FR 44805, (July 21, 2020)).
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Another policy rationale for this final rule is that it addresses
the ever-present risk that future pandemics may present new or
different challenges that demand the prompt exercise of the section 362
authority. A new virus could have a longer incubation period than
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (the virus
that causes COVID-19) or cause a disease that takes longer to run its
course.\9\ In such scenarios, the issuance and maintenance of Federal
quarantine, isolation, and conditional release orders would consume
even more resources than the 2020 interventions with cruise ships. HHS/
CDC would need to have a rule implementing section 362 in place to
promptly implement public health measures tailored to the danger
presented by the virus. Those measures could include quarantine,
isolation, or conditional release under section 361, prohibition of the
introduction of persons under section 362, or some combination of the
two.
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\9\ HHS/CDC's experience with other viruses informs this
concern. Notably, Ebola has an incubation period of 2-21 days. See
Estimating the Future Number of Cases in the Ebola Epidemic--Liberia
and Sierra Leone, 2014-2015, 63 MMWR Supplement 5, Ctrs. for Disease
Control & Prevention, https://www.cdc.gov/mmwr/preview/mmwrhtml/su6303a1.htm (last updated Sep. 26, 2014) (The mean incubation
period for Ebola is 6.3 days, with a median of 5.5 days and a 99th
percentile at 21 days).
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The policy rationale and factual basis for this final rule are
detailed further below.

A. HHS/CDC's Experience Is That Travel and Migration Can Impact the
Spread of Quarantinable Communicable Diseases

Medical and scientific knowledge have increased dramatically in the
past century. But so have international travel and migration, which
play a significant role in the global transmission of quarantinable
communicable diseases that pose risks for vulnerable populations.\10\
Travelers can transmit quarantinable communicable diseases without
actually knowing it, and thereby increase the risk of introduction of
quarantinable communicable diseases into the United States. The risk
increases significantly when travelers are in congregate settings, such
as terminals or carriers with shared sitting, sleeping, eating, or
recreational areas, all of which may be conducive to disease
transmission.\11\
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\10\ See, e.g., Institute of Medicine (US) Forum on Microbial
Threats, Infectious Disease Movement in a Borderless World: Workshop
Summary, Nat'l Acad.'s Press (US); 2010, (available at: https://www.ncbi.nlm.nih.gov/books/NBK45728/) (hereinafter ``Infectious
Disease Movement in a Borderless World''); Wilson, ME, Travel and
the Emergence of Infectious Diseases, 1 Emerging Infectious Diseases
2, 39-46 (1995), (available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2626831/); Tatem, A.J., Rogers, D.J. & Hay, S., Global
Transport Networks and Infectious Disease Spread, Adv. Parasitology
62, 293-343 (2006), (available at: https://www.researchgate.net/publication/7133296).
\11\ See, e.g., Travelers' Health: Cruise Ship Travel, Chapter
8, Ctrs. for Disease Control & Prevention, https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-by-air-land-sea/cruise-ship-travel
(last updated June 24, 2019) (noting that the ``often crowded, semi-
enclosed environments onboard ships can facilitate the spread of
person-to-person, foodborne, or waterborne diseases''); Public
Health Guidance for Potential Exposure to COVID-19 Associated with
International or Domestic Travel, Ctrs. for Disease Control &
Prevention, https://www.cdc.gov/coronavirus/2019-ncov/php/risk-assessment.html (last updated Aug. 6, 2020).
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The speed and far reach of global travel have been factors in prior
outbreaks that expanded to numerous continents.\12\ Examples include:
Severe Acute Respiratory Syndrome (SARS), caused by a coronavirus
(SARS-CoV) in

[[Page 56428]]

2003; the H1N1 influenza pandemic in 2009; tuberculosis; measles;
Middle East Respiratory Syndrome (MERS) caused by a coronavirus (MERS-
CoV) in 2012; and Ebola virus disease in 2014 and 2018. All of these
diseases posed significant public health risks, especially given how
quickly the diseases spread.
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\12\ Infectious Disease Movement in a Borderless World (noting
that ``swine-origin H1N1 has spread globally, its movement hastened
by global air travel'' and [i]t is easy to see how travelers could
play a key role in the global epidemiology of infections that are
transmitted from person to person, such as HIV, SARS, tuberculosis,
influenza, and measles'') (citing Hufnagel L, Brockmann D, & Geisel
T., Forecast and Control of Epidemics in a Globalized World,
Proceedings of the Nat.'l Acad. of Sci.'s 2004;101(42):15124-15129).
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The 2009-2010 H1N1 influenza pandemic is particularly relevant to
this final rule. Although the virus was first identified mid-April 2009
in the United States, the initial cases of 2009 H1N1 influenza occurred
in Mexico, and by late April 2009 transmission of the virus in Mexico
involved person-to-person spread with multiple generations of
transmission.\13\ The first two cases of a novel H1N1 influenza were
discovered in San Diego County, California, and Imperial County,
California.\14\ While San Diego and Imperial Counties are roughly 100
miles apart, both are less than 25 miles from the U.S.-Mexico border,
which suggested cross-border transmission of the disease. Soon after,
public health officials discovered additional H1N1 cases in the two
California counties and two H1N1 cases in Texas, another border
State.\15\ At the same time, CDC identified the novel virus in samples
from Mexico, some of which had been collected from patients who were
ill before the first two U.S. patients, which suggested cross-border
transmission of the disease.\16\ Subsequent epidemiologic
investigations indicated that outbreaks had occurred in Mexico in March
and early April 2009, and that by the end of April the disease was
widespread in Mexico; cases had also been identified in Canada.\17\
HHS/CDC estimates that between April 12, 2009, and April 10, 2010,
approximately 60.8 million cases, 274,304 hospitalizations, and 12,469
deaths occurred in the United States due to H1N1 influenza.\18\ It is
possible that had HHS/CDC suspended the introduction of persons from
Mexico into the United States early in the pandemic, fewer individuals
might have fallen ill or died from H1N1 influenza.
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\13\ Outbreak of Swine-Origin Influenza A (H1N1) Virus
Infection--Mexico, March-April 2009, Ctrs. for Disease Control &
Prevention, https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5817a5.htm
(last updated June 16, 2010); The 2009 H1N1 Pandemic: Summary
Highlights, April 2009-April 2010, Ctrs. for Disease Control &
Prevention, https://www.cdc.gov/h1n1flu/cdcresponse.htm (last
updated Aug. 3, 2010).
\14\ Swine Influenza A (H1N1) Infection in Two Children--
Southern California, March-April 2009, Ctrs. for Disease Control &
Prevention, https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5815a5.htm
(last updated Apr. 22, 2009).
\15\ Update: Swine Influenza A (H1N1) Infections--California and
Texas, April 2009, 16 MMWR Morb Mortal Wkly Rep. 58, 435-37 (May
2009), (available at: https://pubmed.ncbi.nlm.nih.gov/19407739/);
The 2009 H1N1 Pandemic: Summary Highlights, April 2009-April 2010,
Ctrs. for Disease Control & Prevention, https://www.cdc.gov/h1n1flu/cdcresponse.htm (last updated Aug. 3, 2010).
\16\ The 2009 H1N1 Pandemic: Summary Highlights, April 2009-
April 2010, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/h1n1flu/cdcresponse.htm (last updated Aug. 3, 2010).
\17\ Outbreak of Swine-Origin Influenza A (H1N1) Virus
Infection--Mexico, March-April 2009. Ctrs. for Disease Control &
Prevention, https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5817a5.htm
(last updated May 7, 2009).
\18\ Sundar S. Shrestha, et al., Estimating the burden of 2009
pandemic influenza A (H1N1) in the United States (April 2009-April
2010), Clin. Infect. Dis. 2011 Jan 1;52 Suppl 1:S75-82.
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Global travel has increased since the H1N1 influenza pandemic. By
2018, international visits to the United States totaled almost 25
million more per year than in 2009, when the H1N1 influenza pandemic
occurred, and approximately 5 million more per year than in 2014, when
the Ebola virus disease outbreak occurred.\19\ Despite the decrease in
travel in 2020 due to COVID-19 concerns, HHS/CDC expects that the
procedures in this final rule will be vital to public health going
forward.
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\19\ See Fast Facts: United States Travel and Tourism Industry--
2009, 2014 and 2018, Int'l Trade Admin., (available at: https://travel.trade.gov/outreachpages/download_data_table/Fast_Facts_2009.pdf; https://travel.trade.gov/outreachpages/download_data_table/Fast_Facts_2014.pdf; https://travel.trade.gov/outreachpages/download_data_table/Fast_Facts_2018.pdf).
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B. The Response of the United States to the Coronavirus Disease 2019
(COVID-19) Pandemic Shows That This Final Rule Is in the Interest of
U.S. Public Health

Since the COVID-19 pandemic began, the United States has undertaken
a variety of actions to limit the movement of persons into the country
and thereby mitigate the danger of the introduction of COVID-19 into
the country. Those actions have included the Director's exercise of the
section 362 authority and have proven effective notwithstanding the
contagiousness of COVID-19. This rulemaking finalizes procedures that
the Director needs to exercise the section 362 authority and protect
public health now and in the future.
1. COVID-19 Is a Highly Contagious Disease That Threatens Vulnerable
Populations
Because the CDC Director has determined that COVID-19 meets the
definition of a severe acute respiratory syndrome as listed in
Executive Order 13674, COVID-19 is a quarantinable communicable
disease. It is caused by a novel (new) coronavirus, SARS-CoV-2, that
was first identified as the cause of an outbreak of respiratory illness
that began in the city of Wuhan in the Hubei Province of the People's
Republic of China (PRC) in late 2019 and quickly spread worldwide. On
January 30, 2020, the World Health Organization (WHO) declared that the
outbreak of COVID-19 is a Public Health Emergency of International
Concern.\20\ The following day, the Secretary of HHS declared COVID-19
a public health emergency under the PHS Act.\21\ On March 11, 2020, the
WHO declared COVID-19 a pandemic. On March 13, 2020, the President
issued a Proclamation on Declaring a National Emergency Concerning the
Novel Coronavirus Disease (COVID-19) Outbreak.\22\
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\20\ WHO Director-General's statement on IHR Emergency Committee
on Novel Coronavirus (2019-nCoV) (Jan. 30, 2020), WHO, https://www.who.int/dg/speeches/detail/who-director-general-s-statement-on-ihr-emergency-committee-on-novel-coronavirus-(2019-ncov) (last
visited Aug. 27, 2020).
\21\ Determination that a Public Health Emergency Exists, U.S.
Dep't of Health & Human Serv.'s (Jan. 31, 2020), https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
\22\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak, The White House
(Mar. 13, 2020), https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
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As of August 24, 2020, there were 23,057,288 confirmed cases
worldwide. COVID-19 has caused over 800,000 deaths globally,\23\
compared to 774 global deaths from the 2003 SARS outbreak,\24\ 866
global deaths from MERS between April 2012 and January 2020,\25\ and an
estimated 151,700 to 575,400 deaths during the first year of the 2009
H1N1 influenza pandemic.\26\ Compared to other respiratory diseases,
the mortality scale of the COVID-19 pandemic is surpassed in modern
times only by the 1918 influenza pandemic, which claimed an estimated
50 million lives around the world.\27\
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\23\ WHO Sit. Rep. 205 (Aug. 24, 2020), WHO, https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200812-covid-19-sitrep-205.pdf?sfvrsn=627c9aa8_2.
\24\ Severe Acute Respiratory Syndrome (SARS): SARS Basics Fact
Sheet, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/sars/about/fs-sars.html (last updated Dec. 6, 2017).
\25\ MERS situation update, January 2020, WHO, http://www.emro.who.int/pandemic-epidemic-diseases/mers-cov/mers-situation-update-january-2020.html (last visited Aug. 27, 2020).
\26\ Influenza (Flu): 2009 H1N1 Pandemic (H1N1pdm09 virus),
Ctrs. for Disease Control & Prevention, https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html (last updated June 11,
2019).
\27\ Id.; The Deadliest Flu: The Complete Story of the
Reconstruction of the 1918 Pandemic Virus, Ctrs. for Disease Control
& Prevention, https://www.cdc.gov/flu/pandemic-resources/reconstruction-1918-virus.html (last updated Dec. 17, 2019).
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While much is still unknown about the transmission of COVID-19, it
is

[[Page 56429]]

clear that COVID-19 is highly contagious. HHS/CDC estimates that the
viral transmissibility (R0) of COVID-19 is around 2.5, but
may be as high as 4, meaning that a single infected person will on
average infect between 2 to 4 others. Identifying those infected with
COVID-19 can be difficult, as asymptomatic cases are currently believed
to represent roughly 40% of all COVID-19 infections. The infectiousness
of asymptomatic individuals is believed to be about 75% of the
infectiousness of symptomatic individuals. HHS/CDC's current best
estimate is that between 40 to 50% of infections are transmitted prior
to symptom onset (pre-symptomatic transmission).\28\
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\28\ COVID-19 Pandemic Planning Scenarios: Updated July 10,
2020, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios-h.pdf.
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Symptoms of COVID-19 may include fever or chills, cough, shortness
of breath or difficulty breathing, fatigue, muscle or body aches,
headache, new loss of taste or smell, sore throat, congestion or runny
nose, nausea or vomiting, and diarrhea, and typically appear 2-14 days
after exposure to the virus.\29\ Manifestations of severe disease
include severe pneumonia, acute respiratory distress syndrome (ARDS),
septic shock, and multi-organ failure.\30\ Mortality rates are higher
among seniors and those with certain underlying medical conditions,
such as chronic obstructive pulmonary disease (COPD), serious heart
conditions, cancer, Type 2 diabetes, and those with compromised immune
systems.\31\ There are large differences in fatality rate among age and
race cohorts.\32\
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\29\ Coronavirus Disease 2019 (COVID-19): Symptoms of
Coronavirus, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
(last updated May 13, 2020).
\30\ Sevim Zaim, et al., COVID-19 and Multiorgan Response, 00
Current Problems in Cardiology 2020, (available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7187881/pdf/main.pdf).
\31\ Coronavirus Disease 2019 (COVID-19): People with Certain
Medical Conditions, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fneed-extra-precautions%2Fgroups-at-higher-risk.html
(last updated July 30, 2020).
\32\ See National Center for Health Statistics: Weekly Updates
by Select Demographic and Geographic Characteristics--Provisional
Death Counts for Coronavirus Disease 2019 (COVID-19), Ctrs. for
Disease Control & Prevention, https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm (last visited Aug. 31, 2020).
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Early data suggest older people are more likely to have serious
COVID-19 illness, with 8 out of 10 COVID-19-related deaths in the
United States being among adults over the age of 65.\33\ The congregate
care settings of nursing homes and long-term care facilities, where
people reside in confined areas with staff rotating through, increases
the risk of COVID-19 transmission. As of August 16, 2020, an estimated
49,871 nursing home residents died of COVID-19 in the United
States,\34\ representing approximately 30% of all deaths in the United
States.\35\ Prompt identification and isolation of infected persons is
key to reduce further transmission in congregate settings.
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\33\ Coronavirus Disease 2019 (COVID-19): Older Adults, Ctrs.
for Disease Control & Prevention, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html (last updated
Aug. 16, 2020).
\34\ COVID-19 Nursing Home Data, Ctrs. for Medicare and Medicaid
Serv.'s (submitted data as of week ending Aug. 16, 2020), https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg/ (last
visited Sep. 1, 2020).
\35\ Based on 167,201 total deaths in the United States. See WHO
Sit. Rep. 209, WHO (Aug. 16, 2020), https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200816-covid-19-sitrep-209.pdf?sfvrsn=5dde1ca2_2.
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2. The United States Has Taken Broad Actions To Slow the Introduction
of COVID-19 Into the Country and Protect Vulnerable Populations
The United States has taken numerous actions to avert the cross-
border transmission of COVID-19, including presidential proclamations
suspending entry into the United States by certain foreign nationals,
bringing home U.S. citizens and lawful permanent residents (LPRs) from
around the world, quarantine or isolation of repatriates and cruise
ship travelers, the CDC ``No Sail Order'' limiting cruise ship
operations, temporarily limiting travel from Mexico and Canada into the
United States along the United States-Mexico and United States-Canada
land borders to ``essential travel,'' and the CDC Order prohibiting the
introduction of covered aliens into CBP facilities. HHS/CDC believes
that the Federal quarantine and isolation may have slowed the
introduction and spread of COVID-19 into the United States. But they
consumed unsustainable levels of government resources in the process.
In contrast, the actions taken to prevent the movement of potentially
infected persons or contaminated articles into the United States have
reduced the danger of COVID-19 to government personnel and private
sector workers in congregate settings, and reduced the danger of the
introduction of COVID-19 into the United States, while consuming more
sustainable levels of government resources. The balance between the
costs and benefits of actions taken to prevent the movement of
potentially infected persons or contaminated articles into the United
States is one of the reasons why this final rule implementing the
section 362 authority is vital to U.S. public health now and in the
future.
a. Immigration and Nationality Act Section 212(f) Proclamations
The President has exercised his authority under section 212(f) of
the Immigration and Nationality Act (INA), 8 U.S.C. 1182(f), and other
applicable law, to issue a series of proclamations suspending entry
into the country of certain aliens who were physically present in the
PRC (excluding the Special Administrative Regions of Hong Kong and
Macau), the Islamic Republic of Iran, the Schengen Area (comprised of
26 countries in Europe), the United Kingdom (excluding overseas
territories outside of Europe), the Republic of Ireland, or the
Federative Republic of Brazil within 14 days preceding their entry or
attempted entry into the United States. In the proclamations, the
President determined that the foreign countries were experiencing
widespread person-to-person transmission of COVID-19, and the United
States was ``unable to effectively evaluate and monitor'' travelers
entering from the foreign countries, which ``threaten[ed] the security
of our transportation system and infrastructure and the national
security,'' and that the unrestricted entry of foreign nationals who
were physically present in those countries was therefore detrimental to
the interests of the United States.\36\ The proclamations are the first
use of the 212(f) authority aimed at averting the introduction of a
communicable disease into the country.\37\
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\36\ Proclamation No. 10042, 85 FR 32291 (May 28, 2020)
(amending Proclamation 10041); Proclamation No. 10041, 85 FR 31933
(May 28, 2020) (Federative Republic of Brazil); Proclamation No.
9996, 85 FR 15341 (Mar. 18, 2020) (United Kingdom and Republic of
Ireland); Proclamation No. 9993, 85 FR 15045 (Mar. 15, 2020)
(Schengen Area); Proclamation No. 9992, 85 FR 12855 (Mar. 4, 2020)
(Islamic Republic of Iran); Proclamation No. 9984, 85 FR 6709 (Feb.
5, 2020) (PRC).
\37\ Ben Harrington, CONG. RSCH. SERV., LSB10458, Presidential
Actions to Exclude Aliens Under INA Sec. 212 (f) (May 4, 2020)
(available at: https://crsreports.congress.gov/product/pdf/LSB/LSB10458).
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The Director assesses that the proclamations probably mitigated the
introduction of COVID-19 into the United States. By suspending the
entry of thousands of aliens from countries with widespread, ongoing
person-to-person transmission of COVID-19, the President reduced the
number of infected persons who could enter the country. As previously
discussed, a

[[Page 56430]]

single infected person will on average infect between 2 to 4 others.
Therefore, the reduction in the number of infected persons entering the
United States probably helped prevent a larger number of people in the
United States from becoming infected with COVID-19.
b. Quarantine and Isolation of Repatriates and Cruise Ship Travelers
One of the United States' early initiatives in response to the
COVID-19 pandemic was to repatriate U.S. citizens (and their immediate
family members) from Hubei Province, PRC, which was then the epicenter
of the pandemic.\38\ It took place in January and February 2020, and
HHS/CDC is unaware of a repatriation and quarantine operation in the
modern history of the United States that matched the initiative in size
and scope. It involved numerous HHS agencies, including CDC, the Office
of the Assistant Secretary for Preparedness and Response (ASPR), the
Office of the Assistant Secretary for Financial Resources (ASFR), the
U.S. Public Health Service Commissioned Corps (PHSCC), and the
Administration for Children and Families (ACF).\39\ It also involved
the U.S. Department of State, the U.S. Department of Homeland Security
(DHS), and the Department of Defense (DOD), as well as various State
agencies.\40\
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\38\ Transcript for CDC Media Telebriefing: Update on 2019 Novel
Coronavirus (2019-nCoV), Ctrs. for Disease Control & Prevention
(Jan. 31. 2020), https://www.cdc.gov/media/releases/2020/t0131-2019-novel-coronavirus.html (last visited Aug. 31, 2020).
\39\ See Sarah A. Lister, Cong. Rsch. Serv., r46219, Overview of
U.S. Domestic Response to Coronavirus Disease 2019 (COVID-19) (last
updated Mar. 2, 2020), at *12 (available at: https://crsreports.congress.gov/product/pdf/R/R46219).
\40\ Id. at *11-*12; David Vergun, DOD, Other Government
Departments Take Coronavirus Response Measures, U.S. Dep't. of Def.
(Jan. 31, 2020), https://www.defense.gov/Explore/News/Article/Article/2069255/dod-other-government-departments-take-coronavirus-response-measures/.
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The operation required the agencies to secure charter flights from
the PRC to the United States, secure and prepare appropriate facilities
to house individuals, transport individuals to and from these
facilities, implement infection-control and infection-prevention
measures at the facilities, test and medically monitor individuals, and
provide ``wrap-around'' services for individuals (e.g., food and other
necessary personal services).\41\ The agencies had to secure sites
because the Federal government no longer operates Public Health Service
hospitals capable of acting as dedicated quarantine and isolation
facilities able to house hundreds of people for multiple weeks.\42\ The
securing of sites was challenging because when the agencies identified
suitable facilities, local officials sometimes objected to the use of
the facilities.\43\ To provide housing for the repatriates, the
agencies ultimately secured military facilities for use as quarantine
sites, hotels for use as isolation sites, and beds at hospitals for
persons who required medical care. Those sites accepted approximately
800 individuals, the vast majority of whom were repatriates, from Hubei
Province.
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\41\ See e.g., SOC Shift Brief 2019-2020 Coronavirus Response,
U.S. Dep't of Health & Human Serv.'s Assistant Sec'y for
Preparedness & Response (Feb. 8, 2020, 8:00 p.m. EDT) (on file with
HHS); see also Proposed Courses of Action (COAs) & Activities for
Grand Princess Cruise Ship, U.S. Dep't of Health & Human Serv.'s at
*2 (Mar. 6, 2020, 11:30 a.m. EDT) (on file with HHS).
\42\ See Richard A. Bienia, M.D., M.P.H., Emanuel Stein, M.D.,
M.P.H., & Baroline H. Bienia, M.S., United States Public Health
Service Hospitals (1798-1981)--The End of an Era, 308 N. Engl. J.
Med. 166-168 (1983), (available at: https://www.nejm.org/doi/full/10.1056/NEJM198301203080329?journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm&journalCode=nejm).
\43\ On one occasion, a California city sued HHS and California.
The district court, without finding a violation of law by HHS,
issued a temporary restraining order preventing the use of a
proposed quarantine site. TRO and Order Setting Aside Expedited
Hr'g, City of Costa Mesa v. United States., No. 20-cv-00368
(C.D.Cal.), (Feb. 21, 2020), ECF No. 9. Since HHS had to make
decisions about the use of the site quickly, the temporary
restraining order and subsequent litigation operated as a veto on
the use of the site.
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During the same time frame, cruise ships--including the Diamond
Princess (Asia), the Grand Princess (California to Mexico, California
to Hawaii), the Ruby Princess (Australia), and seven Nile River cruise
ships--were associated with a number of COVID-19 clusters and
outbreaks.\44\ In February 2020, the Diamond Princess experienced what,
at the time, was the largest cluster of COVID-19 cases outside of PRC
and included a number of U.S. citizens. HHS/CDC, the Department of
State and other agencies repatriated approximately 329 travelers from
the Diamond Princess to the United States, where they entered
quarantine or isolation at Federal sites.\45\ Following an outbreak
onboard the U.S.-bound Grand Princess in March 2020, HHS/CDC and other
agencies conducted a massive operation to disembark and quarantine or
isolate approximately 2,000 travelers from the Grand Princess at
Federal sites. Approximately 2,300 individuals entered quarantine or
isolation at Federal sites from the repatriations and disembarkations
from the Diamond Princess and Grand Princess cruise ships.
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\44\ See No Sail Order and Suspension of Further Embarkation, 85
FR 16628 (Mar. 24, 2020); Frances Mao, Coronavirus: How did
Australia's Ruby Princess cruise debacle happen?, BBC (Mar. 24,
2020), https://www.bbc.com/news/world-australia-51999845.
\45\ Public Health Responses to COVID-19 Outbreaks on Cruise
Ships--Worldwide, February-March 2020, Ctrs. for Disease Control &
Prevention (Mar. 27, 2020), https://www.cdc.gov/mmwr/volumes/69/wr/mm6912e3.htm.
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To the best of HHS/CDC's knowledge, the combined Federal quarantine
and isolation of individuals from the cruise ships and flights from
Hubei Province, constitute the largest and most burdensome Federal
quarantine and isolation operation in modern American history.
Quarantine sites required support staffs of hundreds of Federal
personnel and contractors working around-the-clock. The entire
operation lasted approximately eight weeks and consumed thousands of
working hours.
One of the key agency components of the operation was the National
Disaster Medical System (NDMS), which is a federal partnership (between
HHS, DOD, VA, and DHS) led by HHS/ASPR. NDMS includes a cadre of
approximately 5,000 part-time Federal employees who are civilian
doctors, nurses, and other healthcare professionals, and who are
activated for short-term, two-week deployments in response to natural
disasters and other emergencies.\46\ The NDMS leverages healthcare
personnel in jurisdictions unaffected by the emergency by temporarily
federalizing those individuals so they may operate where local
resources are overtaxed.\47\ A more protracted operation may have
deprived State and local health systems of the services of the NDMS
personnel for extended periods of time during the COVID-19 pandemic. It
would also have limited the ability of HHS/ASPR to

[[Page 56431]]

re-deploy the NDMS to other emergencies (e.g., hurricanes).
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\46\ NDMS Teams, Off. of the Assistant Sec'y for Preparedness &
Response, U.S. Dep't. of Health & Human Serv.'s, Nat'l Disaster Med.
Sys., https://www.phe.gov/Preparedness/responders/ndms/ndms-teams/Pages/default.aspx (last visited Aug. 11, 2020); Disaster Medical
Assistance Teams, Off. of the Assistant Sec'y for Preparedness &
Response, U.S. Dep't. of Health & Human Serv.'s, Nat'l Disaster Med.
Sys., https://www.phe.gov/Preparedness/responders/ndms/ndms-teams/Pages/dmat.aspx (last visited Aug. 31, 2020).
\47\ NDMS Teams, Off. of the Assistant Sec'y for Preparedness &
Response, U.S. Dep't. of Health & Human Serv.'s, Nat'l Disaster Med.
Sys., https://www.phe.gov/Preparedness/responders/ndms/ndms-teams/Pages/default.aspx (last visited Aug. 11, 2020); Calling on NDMS,
Off. of the Assistant Sec'y for Preparedness & Response, U.S. Dep't.
of Health & Human Serv.'s, Nat'l Disaster Med. Sys., https://www.phe.gov/Preparedness/responders/ndms/Pages/calling-ndms.aspx
(last visited Aug. 31, 2020).
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Moreover, hundreds of other Federal personnel from HHS agencies--
including ASPR, CDC, and the U.S. Public Health Service--were deployed
for quarantine and isolation operations. The U.S. Departments of
Homeland Security, Defense, and State also contributed personnel and
resources. During a public health emergency, many of the agency
personnel would ordinarily perform Federal coordinating functions. A
more expansive or protracted field operation would have jeopardized the
ability of some of the agencies to perform their ordinary functions.
While the Federal quarantine and isolation operation addressed the
immediate risk of individual repatriates and cruise ship travelers
introducing COVID-19 into the United States, it was not a prospective
solution. That is, it did not address the continuing risk of COVID-19
transmission onboard cruise ships. Nor did it address the continuing
risk of cruise ships or other vessels introducing COVID-19 into the
United States in the future. An ongoing Federal quarantine and
isolation operation was not a scalable or sustainable option for
mitigating either of those continuing risks given the finite resources
of the relevant Federal agencies and the other pressing demands of the
COVID-19 pandemic response.
As explained below, CDC's experience with the Federal quarantine
and isolation orders and the resulting operation has informed its
decision-making regarding its No Sail Order for cruise ships, its Order
prohibiting the introduction of covered aliens into the United States,
and ultimately this final rule.
c. The CDC No Sail Order for Cruise Ships
In March 2020, the risk of cruise ships introducing COVID-19 into
the United States remained despite the Federal quarantine or isolation
of thousands of cruise ship travelers. To address this ongoing concern,
on March 14, 2020, the Director issued a No Sail Order under sections
361 and 365 of the PHS Act and 42 CFR 70.2 and 71.32 for all cruise
ships of a certain capacity with itineraries anticipating an overnight
stay for passengers or crew that had not voluntarily suspended
operation.\48\ This No Sail Order was subsequently modified and
extended, effective April 15, 2020,\49\ and again on July 16, 2020,\50\
to include cruise ships that had previously voluntarily suspended
operations, as well as requiring additional measures to prevent the
further introduction, transmission, and spread of disease. The current
No Sail Order remains in place until September 30, 2020, or until the
expiration of the Secretary's declaration that COVID-19 constitutes a
public health emergency, or the Director rescinds or modifies the Order
based on specific public health or other considerations, whichever
occurs first.
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\48\ No Sail Order and Suspension of Further Embarkation, 85 FR
16628 (Mar. 24, 2020).
\49\ No Sail Order and Suspension of Further Embarkation; Notice
of Modification and Extension and Other Measures Related to
Operations, 85 FR 21004 (Apr. 15, 2020) (this modification
additionally relied on the authority of 42 CFR 71.31(b)).
\50\ No Sail Order and Suspension of Further Embarkation; Second
Modification and Extension of No Sail Order and Other Measures
Related to Operations, 85 FR 44085 (July 21, 2020).
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As noted above, the No Sail Order was issued, in part, under
section 361(a) of the PHS Act. Section 361(a) is a sweeping grant of
authority permitting the Director to ``make and enforce such
regulations as in his judgment are necessary to prevent the
introduction . . . of communicable diseases from foreign countries into
the States or possessions[ ].'' (emphasis added). One of those
regulations, 42 CFR 71.32(b), is equally broad. It states that
``[w]henever the Director has reason to believe that any arriving
carrier . . . is or may be infected or contaminated with a communicable
disease, he/she may require detention, disinfection, disinfestation,
fumigation, or other related measures respecting the carrier . . . as
he/she considers necessary to prevent the introduction . . . of
communicable diseases.'' (emphasis added).
In the No Sail Order, the Director determined that he had ``reason
to believe that cruise ship travel may continue to introduce, transmit,
or spread COVID-19.'' That determination rested partly on the
Director's observation that numerous structural and operational
features of cruise ships increase the risk of COVID-19 transmission
onboard.\51\ First, passengers and crew intermingle closely in semi-
enclosed spaces. Second, cruises host events that bring passengers and
crew together in congregate settings, including group and buffet
dining, entertainment, and excursions. Third, cruise ship cabins are
small, increasing the risk of transmission between cabin mates. Fourth,
crew members typically eat and sleep in small, crowded spaces. The
infection of crew members may lead to transmission on sequential
cruises, as the crew members work and live in close quarters from one
cruise to the next.\52\
---------------------------------------------------------------------------

\51\ 85 FR at 16629, 16630.
\52\ Id. at 16629.
---------------------------------------------------------------------------

The Director also observed that cruise ships may spread COVID-19 to
ports of call and passengers' home communities. During a cruise,
disembarkation of passengers at sequential ports of call may spread
COVID-19 to the residents of those ports. Once the cruise ends,
passengers or crew who reside in either the United States or a foreign
country may travel home by airplane. Any infected passengers or crew
may spread COVID-19 to others while traveling home, or upon returning
home, with the end result being interstate spread of COVID-19.\53\
---------------------------------------------------------------------------

\53\ Id. at 16630.
---------------------------------------------------------------------------

Finally, the Director observed that ``[q]uarantine and isolation
measures are difficult to implement effectively onboard a cruise ship
and tend to occur after an infection has already been identified
onboard a cruise. If ships are at capacity, it may not be feasible to
separate infected and uninfected persons onboard the ship, particularly
among the crew. Crew must keep working to keep a ship safely operating,
so effective quarantine for crew is particularly challenging.'' \54\
---------------------------------------------------------------------------

\54\ Id.
---------------------------------------------------------------------------

As part of his analysis, the Director also considered the risks to
the healthcare system in the United States, and the limited government
resources available for the response to COVID-19. HHS/CDC's recent
experience was that the medical needs of persons with severe disease
may be significant. Disembarkations of large numbers of passengers and
crew with severe disease could increase the strain of COVID-19 on
healthcare systems serving port cities, and divert healthcare resources
and supplies away from local communities. Additionally, HHS/CDC's
recent experience was that repatriating and quarantining or isolating
travelers involved complex logistics, imposed financial costs on all
levels of government, and diverted agency leadership, staff, and
resources away from other aspects of the response to the COVID-19
pandemic.\55\
---------------------------------------------------------------------------

\55\ Id.
---------------------------------------------------------------------------

The No Sail Order has proven to be a more efficient public health
measure for cruise ships than quarantine or isolation. It has mitigated
COVID-19 transmission onboard cruise ships, prevented cruise ships from
introducing COVID-19 into the United States, preserved local health
care resources, and enabled HHS/CDC to deploy its

[[Page 56432]]

finite resources towards other aspects of the response to the COVID-19
pandemic. In contrast, the issuance of additional Federal quarantine
and isolation orders of cruise ship passengers and crew would not have
stopped COVID-19 transmission onboard cruise ships and would not have
been scalable to the number of cruise ship passengers and crew that
would have otherwise disembarked in U.S. ports.\56\
---------------------------------------------------------------------------

\56\ Indeed, Federal quarantine and isolation for PortMiami,
known as ``the Cruise Capital of the World,'' would have been
unworkable standing alone. In 2019, PortMiami disembarked 3,357,590
cruise ship passengers, which equates to approximately 64,569
disembarkations per week. CY 2019 W. Hemisphere Port Cargo and
Passenger Counts, Am. Ass'n of Port Auth., https://www.aapa-ports.org/unifying/content.aspx?ItemNumber= 21048 (last visited Aug.
11, 2020). When the annual disembarkations at other U.S. ports--
including Port Everglades (FL) (1,985,337), the Galveston Wharves
(TX) (1,091,341), the Port Authority of New York and New Jersey
(841,261), the Port of Long Beach (CA) (695,921), and the Port of
New Orleans (603,968)--are added to PortMiami, the impracticability
of a Federal quarantine and isolation operation for cruise ships
nationwide is obvious.
---------------------------------------------------------------------------

HHS/CDC's experience underscores why this final rule is vital to
public health. In March 2020, a regulation for exercising the authority
under section 361 of the PHS Act was readily available to the Director.
As a result, HHS/CDC was able to rapidly exercise its section 361
authority and issue the No Sail Order after concluding that quarantine
and isolation were inadequate to address the public health risks
presented by COVID-19 on cruise ships. Once CDC decided to act, it
could do so promptly and was able to more efficiently manage the
problem and preserve finite resources. HHS/CDC likewise needs a final
rule for exercising its section 362 authority so that it can move with
equal dispatch to protect U.S. public health from the introduction of
quarantinable communicable diseases into the country in the future.
HHS/CDC cannot predict when it will need to exercise the authority in
the future, but HHS/CDC needs to be prepared nonetheless. The
experience with cruise ships shows that the immediate availability of a
procedure is important once a policy decision is made that an action
needs to be taken.
d. Travel Restrictions at the Land Ports of Entry Along the United
States-Canada and United States-Mexico Borders
On March 20, 2020, the United States temporarily limited travel
from Mexico and Canada into the United States along the United States-
Mexico and United States-Canada land borders to ``essential travel,''
in order to prevent the further spread of COVID-19. The United States
worked collaboratively with its neighbors to take this measure to
protect the health and safety of its population, after the Secretary of
the Department of Homeland Security determined the risk of continued
transmission and spread of COVID-19 between the countries posed a
``specific threat to human life or national interest.'' \57\ The
restrictions do not apply, however, to U.S. citizens or LPRs returning
to the United States, or to those traveling for ``essential travel,''
which includes travel to work, or to educational institutions, travel
for emergency response, diplomatic travelers, and travel for public
health purposes, among others. The restrictions do not stop legitimate
trade between the three countries because it is critical to preserve
supply chains that ensure that food, fuel, and medicines reach
individuals.\58\
---------------------------------------------------------------------------

\57\ 85 FR at 16547, 16549.
\58\ Id. at 16548-49.
---------------------------------------------------------------------------

These measures were originally in place for 30 days, subject to
reevaluation and further extension in light of the dynamic nature of
the COVID-19 pandemic. Since March 2020, the measures have been
extended in 30-day increments, and are currently effective through
September 21, 2020.\59\ All three countries have recognized that, given
the sustained human-to-human transmission of the virus, travel between
the three nations places the personnel staffing the land ports of entry
(POEs) between the United States, Canada and Mexico, as well as the
individuals traveling through these POEs, at increased danger of
exposure to COVID-19.\60\
---------------------------------------------------------------------------

\59\ 85 FR at 51633-34.
\60\ Id. at 51633, 51635.
---------------------------------------------------------------------------

Similarly, the Director assesses that travel and migration across
U.S. land borders increases the serious danger of introduction of
COVID-19 into the United States. The Director further assesses that
limiting travel to ``essential travel'' has successfully mitigated the
introduction of COVID-19 into the United States for the same basic
reason that the section 212(f) proclamations have proven successful.
The effectiveness of these travel restrictions at land ports of entry
informs this final rule, which creates a permanent procedure for the
Director to use when he or she determines that a temporary prohibition
on the introduction of persons into the United States across U.S. land
borders is necessary to protect U.S. public health.
e. The CDC Order on Covered Aliens
As noted above, HHS issued the IFR to create a temporary procedure
for the Director to invoke his or her delegated authority under section
362 and prevent the introduction of persons from a foreign country or
place into the United States in order to avert the introduction of a
quarantinable communicable disease into the United States.\61\ On the
same day, the Director issued an order suspending the introduction of
certain ``covered aliens'' from Canada and Mexico into Border Patrol
stations and POEs at or near U.S. land borders for 30 days.\62\ The CDC
Order was extended for an additional 30 days on April 20, 2020.\63\ On
May 19, 2020, the Director amended the CDC Order to cover not only
land, but also coastal POEs and Border Patrol stations at or near the
U.S. borders with Canada and Mexico. In addition, the Director extended
the CDC Order indefinitely, subject to recurring 30-day reviews and
eventual termination when the Director determines that continued
implementation is no longer necessary to protect public health.\64\ The
Director has reviewed the CDC Order multiple times and determined each
time that continued implementation of the CDC Order was necessary to
protect U.S. public health.
---------------------------------------------------------------------------

\61\ Control of Communicable Diseases; Foreign Quarantine:
Suspension of Introduction of Persons into United States from
Designated Foreign Countries or Places for Public Health Purposes,
(85 FR 16559) (Mar. 24, 2020).
\62\ Order Under Sections 362 and 365 of the Public Health
Service Act Suspending Introduction of Certain Persons From
Countries Where a Communicable Disease Exists, (85 FR 17060) (Mar.
26, 2020) (effective date Mar. 20, 2020 at 11:59 p.m. EDT)
(hereinafter ``Order'').
\63\ Extension of Order Under Sections 362 and 365 of the Public
Health Service Act, (85 FR 22424) (Apr. 22, 2020) (effective date
Apr. 20, 2020) (hereinafter ``Extension'').
\64\ Amendment and Extension of Order Under Sections 362 and 365
of the Public Health Service Act, (85 FR 31503) (May 26, 2020)
(effective date May 21, 2020 at 12:00 a.m. EDT) (hereinafter
``Amended Order and Extension'').
---------------------------------------------------------------------------

The CDC Order suspends the introduction of ``covered aliens'' into
the United States. The CDC Amended Order and Extension defines
``covered aliens'' as ``persons traveling from Canada or Mexico
(regardless of their country of origin) who would otherwise be
introduced into a congregate setting in a land or coastal [POE] or
Border Patrol station at or near the United States border with Canada
or Mexico, subject to exceptions.'' \65\ There are exceptions for
``U.S. citizens, lawful permanent residents [(LPRs)], and their spouses
and children; members of the armed forces of the United States, and

[[Page 56433]]

associated personnel, and their spouses and children; persons from
foreign countries who hold valid travel documents and arrive at a POE;
or persons from foreign countries in the visa waiver program who are
not otherwise subject to travel restrictions and arrive at a POE.''
\66\ There is also an exception for ``persons whom customs officers
determine, with approval from a supervisor, should be excepted based on
the totality of the circumstances, including consideration of
significant law enforcement, officer and public safety, humanitarian,
and public health interests.'' \67\
---------------------------------------------------------------------------

\65\ Id. at 31504.
\66\ Id.
\67\ Id.
---------------------------------------------------------------------------

In the CDC Order, the Director determined that COVID-19 is a
quarantinable communicable disease that is present in numerous foreign
countries, including Canada and Mexico, and poses a serious danger to
public health in the United States. Covered aliens traveling to the
United States from Canada and Mexico are typically held for material
lengths of time in the congregate areas of Border Patrol stations and
POEs while they undergo immigration processing. As a result, the
introduction of covered aliens into those CBP facilities increases the
serious danger of introducing COVID-19 to others in the facilities--
including DHS personnel, U.S. citizens, U.S. nationals, and LPRs, and
other aliens--and ultimately spreading COVID-19 into the interior of
the United States.
The Director concluded that there are structural and operational
impediments to quarantining and isolating covered aliens in CBP
facilities that neither HHS/CDC nor CBP can overcome, especially given
the large number of covered aliens that move through the congregate
areas of the facilities. Border Patrol stations and POEs were designed
for short-term holding of individuals in congregate settings. They were
not designed and equipped with sufficient interior space or partitions
to quarantine potentially infected persons, or isolate infected
persons. They also are not equipped to provide on-site care to infected
persons who present with severe disease. Some but not all of the
facilities offer basic medical services, and all of them are heavily
reliant on local health care systems for the provision of more
extensive medical services to aliens. Many of the Border Patrol
stations and POEs are located in remote areas and do not have ready
access to local health care systems (which typically serve small, rural
populations and have limited resources).
A Federal quarantine and isolation of covered aliens would have
likely required the procurement or construction and equipping of
numerous permanent or temporary facilities across the Northern and
Southern land borders, in close proximity to the POEs and Border Patrol
stations. The facilities would have to accommodate a rotating
population of covered aliens--including family units, single adults,
and children with varying countries of origin, social customs, and
criminal histories--for the duration of each covered alien's quarantine
or isolation period. During that period, HHS/CDC and CBP would have to
shelter, feed, and provide medical services to each covered alien
onsite. The burden of undertaking such a joint public health and safety
mission across thousands of miles of territory during a pandemic is
impracticable.
As previously discussed, to the knowledge of HHS/CDC, the largest
Federal quarantine and isolation operation in modern U.S. history is
the one that HHS/CDC and other agencies conducted in early 2020 for the
approximately 3,200 persons who disembarked from cruise ships in U.S.
ports or were repatriated from Asia. That operation would have been
dwarfed by an ongoing quarantine and isolation mission for covered
aliens.
CBP has informed HHS/CDC of data in support of the CDC Order. In
the 75-day period before the issuance of the CDC Order on March 20,
2020, an average of 3,292 of individuals who would be covered aliens
under the CDC Order were in custody at POEs and Border Patrol stations
each day. Since March 21, 2020, the daily average has been 895 covered
aliens, notwithstanding an overall 91% increase in Border Patrol
enforcement encounters from 16,201 in April 2020, to 21,687 in May
2020, to 30,936 in June 2020. Between March 21 and June 29, 2020, CBP
encountered more than 75,000 subjects between POEs alone, and over
68,000 of those subjects were covered aliens amenable to expulsion from
the United States under the CDC Order.
HHS/CDC and CBP could not have quarantined or isolated a cumulative
total of more than 68,000 covered aliens between March 21 and June 29,
2020 who were expelled pursuant to the CDC Order.\68\ Nor could they
have quarantined or isolated a daily average population of 3,292
covered aliens from March 21, 2020 to the present.\69\ The relevant
agencies simply lack the personnel and resources to operate such a
large and complex Federal quarantine and isolation program, spread over
thousands of miles of territory, and a period of many months, during a
global pandemic. This is especially true when HHS/CDC and CBP must
prioritize their finite resources for the benefit of the public health
and safety, respectively, of the domestic population.\70\
---------------------------------------------------------------------------

\68\ To put that number in context, the U.S. Census Bureau
estimates that the population of Rockville, Maryland (a suburb of
Washington, DC) in 2019 was approximately 68,079 people. City & Town
Population Totals: 2010-2019, U.S. Census Bureau, https://www.census.gov/data/datasets/time-series/demo/popest/2010s-total-cities-and-towns.html (last visited Aug. 31, 2020).
\69\ If CDC and CBP had undertaken a Federal quarantine and
isolation operation for covered aliens, the daily average population
of covered aliens in custody and subject to quarantine or isolation
may have exceeded 3,292 for at least two reasons. First, CBP's
enforcement encounters increased monthly after March 20, 2020.
Second, many covered aliens would have spent longer in Federal
quarantine and isolation than they would have spent in CBP custody
before the COVID-19 pandemic.
\70\ HHS/CDC considered whether it could avert the serious
danger of the introduction of COVID-19 into CBP facilities through
COVID-19 testing. Specifically, HHS/CDC considered the asymptomatic
transmission of COVID-19; the lack or limited availability of
diagnostic testing for COVID-19; the time required to obtain
diagnostic test results; the need to prioritize testing resources
for the domestic population; the impracticability of implementing
quarantine, isolation, and social distancing in CBP facilities; and
resource constraints. HHS/CDC concluded that the better option for
public health was to prohibit the introduction of covered aliens
into the congregate areas in CBP facilities.
HHS/CDC expects to face similar policy decisions in the future.
In any pandemic caused by a novel virus that spreads
asymptomatically there will be a period when diagnostic testing is
not widely available due to the time necessary to create,
manufacture, distribute, administer, and receive the results of
diagnostic tests. Even then, it may be appropriate to prioritize
diagnostic testing for some populations over others, and diagnostic
testing may produce at least some false negatives. Plus, diagnostic
testing is a snapshot in time. An uninfected person who undergoes
diagnostic testing and enters a congregate setting pending test
results may become infected by others. An asymptomatic, infected
person who undergoes diagnostic testing and enters a congregate
setting may infect others. While surveillance testing can be an
effective alternative, it can consume tremendous resources.
As HHS/CDC's experience here shows, a prohibition on the
introduction of persons into congregate settings may be a better
option for protecting public health than testing, particularly when
finite testing resources must be prioritized for the domestic
population.
---------------------------------------------------------------------------

While the CDC Order succeeded in reducing the average number of
covered aliens in CBP custody each day, and dramatically reduced the
danger of the introduction of COVID-19 into CBP facilities, the
unfortunate reality is that the COVID-19 pandemic has still impacted
CBP's ability to perform its public safety mission. CBP informs HHS/CDC
that, as of August 7, 2020, it

[[Page 56434]]

has had 1,806 employees test positive for COVID-19, a 56% increase
compared to the 1,158 who tested positive on July 7, 2020. Tragically,
ten employees and one CBP contractor have died from COVID-19 as of the
same day. CBP does not have the capability to identify the mechanism by
which each CBP employee or contractor becomes infected; CBP employees
or contractors may become infected through exposures that occurred in
their communities through interactions outside of work or in their
workplaces, including Border Patrol stations and POEs. In any event,
when CBP employees test positive and do not require inpatient care,
they must self-isolate at home until they recover and are no longer
contagious.
CBP also has a large, rotating group of employees who are self-
quarantined based on potential exposure to COVID-19. CBP informs HHS/
CDC that over 1,500 CBP employees were quarantined as of the end of
June, and the impact was more pronounced at the Southwest border, where
975 U.S. Border Patrol employees, representing approximately 6% of the
Southwest border personnel, were quarantined as of July 9, 2020.
Overall, based on information provided by CBP to HHS/CDC, the
COVID-19 pandemic has impacted the Laredo Border Patrol Sector and the
Laredo Field Office along the Southwest border area the most of any CBP
area of responsibility. As of July 16, 2020, Border Patrol had a
cumulative total of 91 personnel in the Laredo Sector test positive for
COVID-19. Border Patrol also had 134 personnel, representing 7% of its
workforce in the Laredo Sector, in self-quarantine. To maintain border
security notwithstanding the loss of personnel, the Border Patrol has
had to increase the number of shifts for law enforcement officers at
Border Patrol checkpoints, reassign other personnel to checkpoints, and
suspend certain law enforcement trainings. Similarly, as of July 16,
2020, the Laredo Field Office (which operates the Laredo POE, as well
as many other land POEs in the State of Texas) had a cumulative total
of 189 employees test positive for COVID-19, and had 151 personnel
(representing 5% of its workforce) in quarantine. The Laredo Field
Office has mitigated the loss of personnel by shifting law enforcement
officers from passenger vehicle and migrant processing (which has
decreased in volume) to commercial vehicle processing (which has
generally stayed consistent).
The Director assesses that the numbers of CBP employees who test
positive for COVID-19 or enter quarantine would probably be larger
absent the CDC Order. While it is difficult to quantify the difference,
CBP informs HHS/CDC that any further degradation of its workforce in
the Laredo Sector would jeopardize CBP's ability to execute its public
safety mission.\71\ Because the CDC Order has prevented COVID-19 from
further degrading the CBP workforce, the IFR and CDC Order have served
the purpose of section 362, which is to avert an increase in the
serious danger of the introduction into the United States of a
quarantinable communicable disease from abroad.
---------------------------------------------------------------------------

\71\ CBP, for example, informs HHS/CDC that Border Patrol might
have to shift law enforcement officers from patrols of the U.S. land
border to migrant custody and transportation functions, which would
increase the risk of transnational criminal organizations smuggling
narcotics or migrants through the Laredo Sector. The Laredo Field
Office might lose its ability to timely process commercial vehicles,
which would slow the flow of goods into the United States. And CBP
supervisors might have to deny leave requests to maintain staffing
levels, which would overtax the CBP workforce.
---------------------------------------------------------------------------

Beyond the CBP workforce, CBP has provided data to HHS/CDC showing
that the CDC Order has reduced the strain on the health care systems in
U.S. border states at a time when those systems are trying to safeguard
their own workforces from COVID-19 and prioritize health care resources
for the domestic population. In the 50 days preceding the issuance of
the CDC Order, CBP officers made over 1,600 trips to U.S. hospitals to
take migrants to receive medical care. In the first 80 days after the
issuance of the CDC Order, CBP has made only 400 such trips. This
represents a 75% decrease in utilization of U.S. hospitals by migrants,
which is material when hospitals in U.S. border states in mid-July were
operating at or near their inpatient bed capacity for COVID-19
patients,\72\ or taking measures to absorb a surge in COVID-19 cases
within the domestic population.\73\ The Director assesses that the
risks of COVID-19 transmission and insufficient bed capacity in health
care systems serving U.S. border states would have been greater absent
the Order.
---------------------------------------------------------------------------

\72\ For example, local news media in Laredo, Texas, reported on
July 11, 2020 that two acute care hospitals in the area, Laredo
Medical Center and Doctor's Hospital, were in a critical situation.
Laredo Medical Center was at 100 percent capacity in its COVID
intensive care unit and on its non-ICU COVID patient floors, with
four people in the emergency department waiting on beds. The COVID
intensive care units at Doctors Hospital were approaching 100
percent capacity, and its non-ICU COVID patient floors were at 100
percent capacity. Local hospital COVID-19 ICU at capacity, KGNS
(July 11, 2020, 12:13 a.m. EDT), https://www.kgns.tv/2020/07/11/local-hospital-covid-19-icu-at-capacity/. Other hospitals in Texas
border communities experienced similar surges. Sarah R. Champagne,
Ten out of the 12 hospitals in Texas' Rio Grande Valley are now
full, Tex. Trib. (July 4, 2020, 6:00 p.m.), https://www.texastribune.org/2020/07/04/texas-coronavirus-rio-grande-valley-hospitals/.
\73\ Allison Steinbach, Arizona reports 4,273 new COVID-19
cases, sets new records for hospital beds in use, Ariz. Rep. (July
14, 2020, 12:48 p.m.), https://www.azcentral.com/story/news/local/arizona-health/2020/07/14/arizona-coronavirus-update-hospital-beds-fill-up-4-273-new-cases/5434525002/; Soumya Karlamangla, `We're just
overwhelmed': The view from inside hospitals as coronavirus surge
hits, L.A. Times (July 13, 2020, 5:00 a.m.), https://www.latimes.com/california/story/2020-07-13/overwhelmed-hospitals-coronavirus-surge-california.
---------------------------------------------------------------------------

The effectiveness of the CDC Order as a public health measure
reinforces why this final rule is vital to public health. HHS/CDC needs
a readily available procedure for exercising the section 362 authority
so that it may continue to protect public health during the COVID-19
pandemic, and respond to future public health threats with equal
efficacy.
3. Other Jurisdictions Have Taken Similar Actions To Slow the
Introduction of COVID-19, Which Underscores Why This Final Rule Is in
the Interest of U.S. Public Health
Global efforts to slow cross-border COVID-19 transmission have
included public health actions substantially similar to those taken by
the United States. Nations such as the European Union (EU) Member
States and Schengen Area countries,\74\ Australia, New Zealand, and
Canada have imposed restrictions on international travelers.\75\ The
actions of other nations to avert the introduction of COVID-19 further
corroborate the Director's view that this final rule will help HHS/CDC
protect public health now and in the future.
---------------------------------------------------------------------------

\74\ Migration and Home Affairs: Schengen Area, Eur. Comm'n
(Jan. 1, 2020), https://ec.europa.eu/home-affairs/what-we-do/policies/order-and-visas/schengen_en (``Today, the Schengen Area [of
the EU] encompasses most EU States, except for Bulgaria, Croatia,
Cyprus, Ireland and Romania. However, Bulgaria, Croatia and Romania
are currently in the process of joining the Schengen Area. Of non-EU
States, Iceland, Norway, Switzerland and Liechtenstein have joined
the Schengen Area.''); Travel to and from the EU during the
pandemic: Travel restrictions, Eur. Comm'n, https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/travel-and-transportation-during-coronavirus-pandemic/travel-and-eu-during-pandemic_en (last visited Aug. 31, 2020).
\75\ See Andrea Salcedo, Sanam Yar, & Gina Cherelus, Coronavirus
Travel Restrictions, Across the Globe, N.Y. Times (July 16, 2020),
https://www.nytimes.com/article/coronavirus-travel-restrictions.html.
---------------------------------------------------------------------------

a. The European Union and Schengen Area
EU Member States and Schengen countries have implemented
restrictions on international travel similar to those imposed by the
United States. Based on a recommendation by the European

[[Page 56435]]

Commission, on March 17, 2020, EU Member States agreed to restrict non-
essential travel across the EU's external border for a period that has
now been extended several times.\76\
---------------------------------------------------------------------------

\76\ Travel and transportation during the coronavirus pandemic:
Travel restrictions, Eur. Comm'n, https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/travel-and-transportation-during-coronavirus-pandemic/travel-and-eu-during-pandemic_en (last visited Aug. 31, 2020).
---------------------------------------------------------------------------

Restrictions on international travel into the EU and Schengen Area
were quickly followed by EU Member States and Schengen Area countries
closing their national borders. Such internal border controls were
initially tailored to the countries hardest hit by the pandemic. For
example, Austria and Switzerland closed their land borders with Italy
on March 11 and 13, 2020, respectively, to prevent the entry of
individuals from Italy, which was an epicenter of the COVID-19 pandemic
at that time.\77\ Similarly, Portugal closed its land border with Spain
as part of sweeping measures to counter COVID-19 transmission.\78\
Given the level of economic interdependence and commitment to the
unrestricted movement of goods and persons within the EU, the closing
of internal borders within the EU and Schengen Area is akin to
individual U.S. States closing their borders to interstate travelers.
During the height of the COVID-19 pandemic, a large number of EU Member
States and Schengen countries had closed their internal borders, often
times cancelling international air travel and cross-border train
travel.\79\
---------------------------------------------------------------------------

\77\ Id.; Member States' notifications of the temporary
reintroduction of border control at internal borders pursuant to
Article 25 and 28 et seq. of the Schengen Borders Code, EU, https://ec.europa.eu/home-affairs/sites/homeaffairs/files/what-we-do/policies/borders-and-visas/schengen/reintroduction-border-control/docs/ms_notifications_-_reintroduction_of_border_control_en.pdf
(last visited Aug. 31, 2020).
\78\ Id.; Travel and transportation during the coronavirus
pandemic: Travel restrictions, Eur. Comm'n, https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/travel-and-transportation-during-coronavirus-pandemic/travel-and-eu-during-pandemic_en (last visited Aug. 31, 2020).
\79\ Id.; Member States' notifications of the temporary
reintroduction of border control at internal borders pursuant to
Article 25 and 28 et seq. of the Schengen Borders Code, EU, https://ec.europa.eu/home-affairs/sites/homeaffairs/files/what-we-do/policies/borders-and-visas/schengen/reintroduction-border-control/docs/ms_notifications_-_reintroduction_of_border_control_en.pdf
(last visited Aug. 31, 2020).
---------------------------------------------------------------------------

On June 11, 2020, the European Commission adopted a Communication
\80\ which set out an approach to progressively lift internal border
controls by June 15, and to prolong the restriction on non-essential
travel into the EU until June 30, 2020.\81\ Each Member State's
internal border controls continue to be independently determined by the
States themselves. Within the Schengen Area, internal border
restrictions and quarantine requirements for intra-Schengen travelers
began to relax in late-June 2020 as the rate of COVID-19 transmission
slowed in most Schengen Area countries.\82\ Nevertheless, several
Schengen Area countries with low levels of COVID-19 transmission and
few confirmed cases, such as Latvia, Lithuania, and Norway, continued
to require citizens from other Schengen Area countries to self-
quarantine on arrival, or limit travel to specific purposes.\83\
Schengen Area countries have also implemented varying public health
interventions, such as bans on public gatherings, compulsory stay-at-
home orders, closures of schools and nonessential businesses, and face
mask ordinances.
---------------------------------------------------------------------------

\80\ Press Release IP/20/1035, Coronavirus: European Commission
recommends partial and gradual lifting of travel restrictions to the
EU after 30 June, based on common coordinated approach (June 11,
2020) (available at: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1035).
\81\ Id.; Travel and transportation during the coronavirus
pandemic, Eur. Comm'n, https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/travel-and-transportation-during-coronavirus-pandemic/travel-and-eu-during-pandemic_en (last visited
Aug. 31, 2020).
\82\ Id.
\83\ See e.g., If returning to/entering Latvia, Lat. Ctr. for
Disease Prevention & Control, https://www.spkc.gov.lv/lv/if-returning-toentering-latvia (last updated July 22, 2020) (links to
list last updated August 28, 2020); The updated list of countries
for mandatory 14-day isolation upon return, Gov.t of the Rep. of
Lith., https://koronastop.lrv.lt/en/news/the-updated-list-of-countries-for-mandatory-14-day-isolation-upon-return-1 (last updated
July 27, 2020); Travel advice, Health Ministry of Nor., https://helsenorge.no/koronavirus/travel-advice#Travel-quarantine (last
updated Aug. 24, 2020).
---------------------------------------------------------------------------

On June 25, 2020, the European Commission adopted a proposal for a
Council Recommendation to lift some travel restrictions for countries
selected together by EU Member States.\84\ Selection was based on a set
of principles and objective criteria including the health situation in
respective countries, the ability to apply containment measures during
travel, and reciprocity considerations, taking into account data from
sources such as the European Centre for Disease Prevention and Control
and the WHO.\85\ Based on the criteria and conditions set out in the
Recommendation, and on the updated list published by the Council on
August 7, 2020, the European Commission says EU Member States should
start lifting travel restrictions at external borders for residents
from 11 countries.\86\
---------------------------------------------------------------------------

\84\ Travel to and from the EU during the pandemic: Travel
restrictions, Eur. Comm'n, https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/travel-and-transportation-during-coronavirus-pandemic/travel-and-eu-during-pandemic_en (last
visited Aug. 31, 2020).
\85\ Id.
\86\ These countries are: Australia, Canada, Georgia, Japan, New
Zealand, Rwanda, South Korea, Thailand, Tunisia, Uruguay, and China
(subject to confirmation of reciprocity). Id.
---------------------------------------------------------------------------

The external and internal border controls imposed in the EU and
Schengen Area resemble the measures undertaken by the United States to
avert the introduction of COVID-19 into the country, including the IFR
and CDC Order. EU Member States have based their decisions to close and
then reopen borders on the reported severity of the COVID-19 pandemic
in the countries that travelers are entering from. The combination of
external and internal border controls and public health interventions
in the EU and Schengen Area appear to have reduced not only cross-
border COVID-19 transmission but also internal community spread of the
disease to the point of enabling the relaxation of some restrictions.
The experiences of EU Member States and Schengen Area countries
reinforce the Director's view that this final rule is an important tool
for protecting public health in the United States.
b. Australia and New Zealand
Australia and New Zealand have implemented external border closures
as part of their response to the COVID-19 pandemic that are much more
stringent than the measures taken by the United States. On March 19,
2020, Australia closed its borders with exemptions only for Australian
citizens, permanent residents, and their immediate families, including
spouses, legal guardians, and dependents, as well as other certain
other limited exceptions.\87\ All returning citizens and residents of
Australia are subject to a mandatory 14-day quarantine at designated
secure facilities, such as a hotel at their port of arrival.\88\ In
order to manage the return of citizens and residents, Australia has
capped international arrivals at 1,875 passengers per week.\89\ Most
visa

[[Page 56436]]

holders, including those providing critical or specialist medical
services, including air ambulance and medical evacuations, are not
allowed to enter Australia unless they apply for and are granted an
exemption and it is approved in advance of travel.\90\ International
visitors to be granted an exemption and permitted to travel to
Australia may be required to pay up to $5,000 (AUD) to defray the cost
of their quarantine.\91\
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\87\ Media Statement, Prime Minister of Australia announces
Border Restrictions (Mar. 19, 2020) (available at: https://www.pm.gov.au/media/border-restrictions).
\88\ Id.; COVID-19 and the border: Travel restrictions, Cmlth.
of Austl, Dep't of Home Aff., https://covid19.homeaffairs.gov.au/travel-restrictions-0 (last updated Aug. 28, 2020).
\89\ Media Statement, National Cabinet meets to discuss
Australia's COVID-19 response, the Victoria outbreak, easing
restrictions, helping Australians prepare to go back to work, and
economic recovery (Aug. 7, 2020) (available at: https://www.pm.gov.au/media/national-cabinet-7aug2020) This cap will be in
effect until October 24, 2020. Id. A slightly lower cap of 1,475
passengers took effect on Monday July 13, 2020 and was re-evaluated
and increased in late July. Media Statement, National Cabinet
discusses Australia's current COVID-19 response, easing
restrictions, helping Australians prepare to go back to work (July
10, 2020) (available at: https://www.pm.gov.au/media/national-cabinet).
\90\ COVID-19 and the border: Travel restrictions, Cmlth. of
Austl., Dep't of Home Aff., https://covid19.homeaffairs.gov.au/travel-restrictions-0 (last updated Aug. 28, 2020).
\91\ For example, from July 17, 2020, anyone arriving in the
Northern Territory from a declared COVID-19 hotspot must pay a
quarantine fee of $2,500 for an individual, or $5,000 for family
groups of two or more people in a shared accommodation for the
duration of the 14-day quarantine. Mandatory supervised quarantine
fee Interstate travellers from a COVID-19 Hotspot and International
Travellers, N. Terr. Gov't, https://coronavirus.nt.gov.au/travel/quarantine/quarantine-fee (last updated Aug. 24, 2020).
---------------------------------------------------------------------------

Australia had only 25,322 confirmed cases and 572 deaths from
COVID-19 as of August 27, 2020.\92\ And as recently as June 26, 2020
Australia was planning a safe return of crowds to stadiums, arenas, and
large theaters,\93\ and had announced its intention to create a trans-
Tasman COVID-safe travel zone with New Zealand.\94\ Nevertheless, an
outbreak in Melbourne, Victoria in July 2020, believed to be caused by
infection control failures at quarantine facilities,\95\ led to the
imposition of restrictive public health measures in Melbourne,
including a compulsory stay-at-home order limiting the reasons people
can leave their homes,\96\ and a declaration of disaster in the State
of Victoria generally.\97\ Neighboring States have imposed interstate
travel restrictions, including prohibiting persons traveling from
Victoria from entering adjoining States.\98\ Still, preliminary
epidemiological analysis suggests that Australia's travel restrictions
were effective in mitigating the introduction of COVID-19 into the
country.\99\
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\92\ Coronavirus (COVID-19) at a glance--27 August 2020, Cmlth
of Austl. Dep't of Health (Aug. 27, 2020), https://www.health.gov.au/resources/publications/coronavirus-covid-19-at-a-glance-27-august-2020.
\93\ Australian Health Protection Principal Committee (AHPPC)
statement on the safe return of crowds to stadiums, arenas and large
theatres, Cmlth. of Austl. Dep't of Health (June 26, 2020), https://www.health.gov.au/news/australian-health-protection-principal-committee-ahppc-statement-on-the-safe-return-of-crowds-to-stadiums-arenas-and-large-theatres.
\94\ Media Statement, Joint Statement--Prime Ministers Jacinda
Ardern and Scott Morrison Announce Plans for Trans-Tasman COVID-SAFE
Travel Zone (May 5, 2020) (available at: https://www.pm.gov.au/media/joint-statement-prime-ministers-jacinda-ardern-and-scott-morrison-announce-plans-trans-tasman). As of mid-August, the plans
for a trans-Tasman travel ``bubble'' had been put on pause. Trans-
Tasman bubble `on pause' amid new Covid outbreaks across Pacific,
The Guardian (Aug. 13, 2020 13:30 EDT), https://www.theguardian.com/world/2020/aug/14/trans-tasman-travel-bubble-on-pause-amid-new-covid-outbreaks-across-pacific.
\95\ See Media Statement, National Cabinet discusses Australia's
current COVID-19 response, easing restrictions, helping Australians
prepare to go back to work (July 10, 2020) (available at: https://www.pm.gov.au/media/national-cabinet).); Coronavirus: Why has
Melbourne's outbreak worsened?, BBC (July 3, 2020), https://www.bbc.com/news/world-australia-53259356.
\96\ Updated restrictions--11.59 p.m. Wednesday 22 July 2020,
St. Gov't of Vict., Dep't of Health & Human Serv.'s, https://www.dhhs.vic.gov.au/updates/coronavirus-covid-19/updated-restrictions-1159pm-wednesday-22-july-2020 (last updated July 22,
2020); Stage 4 Restrictions, St. Gov't of Vict., Dep't of Health &
Human Serv.'s, https://www.dhhs.vic.gov.au/stage-4-restrictions-covid-19 (last updated Aug. 21, 2020).
\97\ Premier's statement on changes to regional restrictions,
St. Gov't of Vict., Dep't of Health & Human Serv.'s (Aug. 2, 2020),
https://www.dhhs.vic.gov.au/updates/coronavirus-covid-19/premiers-statement-changes-regional-restrictions.
\98\ See e.g., Travel Restrictions, S. Austl. St. Gov't, https://www.covid-19.sa.gov.au/restrictions-and-responsibilities/travel-restrictions#intosa (last visited Aug. 28, 2020) (``Travellers from
Victoria, other than approved categories of Essential Travellers,
are not permitted to travel to South Australia. Checkpoints or road
blocks will be set up at all border crossings between South
Australia and Victoria.''); NSW-Victoria border restrictions, N.S.W.
St. Gov't, https://www.nsw.gov.au/covid-19/what-you-can-and-cant-do-under-rules/border-restrictions#who-can-enter-nsw (last visited Aug.
28, 2020) (``NSW has temporarily shut its border with Victoria to
contain the spread of COVID-19'').
\99\ Valentina Costantino et al., The effectiveness of full and
partial travel bans against COVID-19 spread in Australia for
travelers from China during and after the epidemic peak in China, J.
Travel Med. (May 22, 2020), https://academic.oup.com/jtm/article/doi/10.1093/jtm/taaa081/5842100#205346339.
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New Zealand has taken an even more aggressive approach than
Australia. It closed its borders to ``all but critical travel'' in the
interests of public health.\100\ Only New Zealand citizens, their
partners and dependent children, and accredited diplomats may travel to
New Zealand without prior approval. New Zealand exempts a small number
of categories of travelers from the ban on entering the country,
including ``critical humanitarian travel'' granted at the discretion of
New Zealand immigration authorities. Any non-citizen or legal resident
seeking to enter the country under an exemption must meet a critical
purpose and be approved in advance.\101\ New Zealand has suspended visa
processing for offshore applicants because people who are not New
Zealand citizens or residents are unlikely to meet the current entry
requirements.\102\ New Zealand has suspended its involvement in refugee
resettlement programs and stopped accepting its quota of around 1,500
refugees every year.\103\
---------------------------------------------------------------------------

\100\ Border closures and exceptions, N.Z. Immigration, https://www.immigration.govt.nz/about-us/covid-19/border-closures-and-exceptions (last visited Aug. 25, 2020).
\101\ Id.
\102\ COVID-19: Key updates, N.Z. Immigration, https://www.immigration.govt.nz/about-us/covid-19/coronavirus-update-inz-response (last visited Aug. 28, 2020).
\103\ Immigration Factsheets: COVID-19 response--Quota Refugees,
N.Z. Immigration (July 6, 2020), https://www.immigration.govt.nz/documents/media/covid-19-quota-refugees-factsheet.pdf; see generally
New Zealand Refugee Quota Programme, N.Z. Immigration, https://www.immigration.govt.nz/about-us/what-we-do/our-strategies-and-projects/supporting-refugees-and-asylum-seekers/refugee-and-protection-unit/new-zealand-refugee-quota-programme (last visited
Aug. 28, 2020); Increasing New Zealand's Refugee Quota, N.Z.
Immigration, https://www.immigration.govt.nz/about-us/what-we-do/our-strategies-and-projects/refugee-resettlement-strategy/rqip (last
visited Aug. 28, 2020).
---------------------------------------------------------------------------

Any person still permitted to travel to New Zealand, almost
exclusively citizens and residents, must submit to a medical
examination and testing upon arrival, and is subject to a 14-day
quarantine or isolation period at a government-managed facility.\104\
Quarantine is required regardless of whether the individual tested
negative for COVID-19 on arrival and without respect to whether the
person is exhibiting any symptoms of COVID-19.\105\ Although New
Zealand has not previously charged travelers for quarantine and
isolation costs, effective August 10, 2020, the government will charge
$3,100 (NZ) for one adult; $950 (NZ) for each additional adult in the
same room; and $475 (NZ) for each additional child aged 3-17 in the
same room for those kept in quarantine and isolation.\106\ New Zealand
has also closed its maritime border to all foreign ships, including
cruise ships, with limited exceptions.\107\
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\104\ COVID-19: New Zealanders in the UK--Frequently Asked
Questions, N.Z. Foreign Aff. & Trade, https://www.mfat.govt.nz/en/countries-and-regions/europe/united-kingdom/new-zealand-high-commission/living-in-the-uk/covid-19-coronavirus/ (last visited Aug.
28, 2020).
\105\ See Id.
\106\ Id. (There is no charge for children under the age of
three).
\107\ COVID-19 Public Health Response (Maritime Border) Order
2020, Parl. Couns. Off. (June 30, 2020), http://www.legislation.govt.nz/regulation/public/2020/0134/latest/whole.html#LMS363210.
---------------------------------------------------------------------------

New Zealand's so-called elimination strategy for COVID-19,
consisting of border controls, case detection and surveillance, and
contact tracing and

[[Page 56437]]

quarantine has been widely hailed as a success.\108\ Restricting nearly
all international travel and immigration, paired with domestic public
health interventions, gave New Zealand time to put in place the
infrastructure needed to carry out its elimination strategy.\109\ On
August 28, 2020, New Zealand announced 12 new cases of COVID-19 that
are being managed in isolation, bringing the total to 130 active
cases.\110\
---------------------------------------------------------------------------

\108\ See COVID-19: Elimination strategy for Aotearoa New
Zealand, Ministry of Health, https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-current-situation/covid-19-elimination-strategy-aotearoa-new-zealand (last
updated May 8, 2020); Anna Jones, Coronavirus: How New Zealand went
'hard and early' to beat Covid-19, BBC News (July 10, 2020), https://www.bbc.com/news/world-asia-53274085; Jason Douglas, As Coronavirus
Surges in U.S., Some Countries Have Just About Halted It, The Wall
Street J. (July 6, 2020), https://www.wsj.com/articles/as-coronavirus-surges-in-u-s-some-countries-have-just-about-halted-it-11594037814.
\109\ See Michael G. Baker et al., New Zealand's elimination
strategy for the COVID-19 pandemic and what is required to make it
work, 133 N.Z. Med. J. 1512, 10 (2020), (available at: https://www.nzma.org.nz/journal-articles/new-zealands-elimination-strategy-for-the-covid-19-pandemic-and-what-is-required-to-make-it-work).
\110\ Media Release: NZ Ministry of Health Announces 12 new
cases of COVID-19 (Aug. 28, 2020) (available at: https://www.health.govt.nz/news-media/media-releases/12-new-cases-covid-19).
---------------------------------------------------------------------------

The experiences of New Zealand and Australia, like the experiences
of the EU Member States and Schengen Area countries, reinforce the CDC
Director's view that this final rule is an important tool for
protecting public health in the United States.
c. Canada
On March 20, 2020, the United States and Canada announced plans to,
by mutual consent, temporarily limit non-essential travel along the
United States-Canada land border.\111\ As noted above, these measures
were extended through September 21, 2020.\112\
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\111\ Fact Sheet: DHS Measures on the Border to Limit the
Further Spread of Coronavirus, Dep't of Homeland Sec., https://www.dhs.gov/news/2020/06/16/fact-sheet-dhs-measures-border-limit-further-spread-coronavirus (last updated Aug. 14, 2020).
\112\ 85 FR 51634 (August 21, 2020).
---------------------------------------------------------------------------

Like Australia and New Zealand, Canada banned almost all other
foreign nationals from entering the country. On June 30, 2020, Canada
extended its public health restrictions on international travelers from
countries other than the United States, and on immigration to Canada,
through at least July 31, 2020.\113\ Most foreign nationals cannot
travel to Canada unless they are an immediate family member of a
Canadian national or permanent resident, or are traveling for one of a
limited number of essential purposes and are either traveling directly
from the United States or exempt from travel restrictions.\114\ All
foreign nationals eligible to enter Canada must undergo health
assessments, and have plans to self-quarantine for 14 days, that
include where they are staying, how they plan to get to where they are
staying, and how they will get groceries and access essential services.
Failure to have an adequate quarantine plan is grounds to be denied
entry.\115\ Returning Canadians are also required to quarantine for 14
days, during which individuals are not permitted to leave quarantine
except for medical attention and may not have visitors.\116\ Failure to
adhere to quarantine requirements is punishable by up to six months
imprisonment, a fine of up to $750,000 (CAD), a finding of
inadmissibility, removal from Canada, and a one-year entry ban.\117\
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\113\ Press Release, Canada Extends Mandatory Requirements Under
the Quarantine Act for Anyone Entering Canada (Jun. 30, 2020)
(available at: https://www.canada.ca/en/public-health/news/2020/06/canada-extends-mandatory-requirements-under-the-quarantine-act-for-anyone-entering-canada.html), (last updated July 3, 2020).
\114\ Id.; see also Coronavirus disease (COVID-19): Who can
travel to Canada--Citizens, permanent residents, foreign nationals
and refugees, Gov't of Can., https://www.canada.ca/en/immigration-refugees-citizenship/services/coronavirus-covid19/travel-restrictions-exemptions.html (last updated Aug. 13, 2020).
\115\ Id.
\116\ For travellers without symptoms of COVID-19 returning to
Canada, Gov't of Can., https://www.canada.ca/en/public-health/services/publications/diseases-conditions/2019-novel-coronavirus-information-sheet.html (last updated Aug. 7, 2020).
\117\ Coronavirus disease (COVID-19): Who can travel to Canada--
Citizens, permanent residents, foreign nationals and refugees, Gov't
of Can., https://www.canada.ca/en/immigration-refugees-citizenship/services/coronavirus-covid19/travel-restrictions-exemptions.html
(last updated Aug. 13, 2020).
---------------------------------------------------------------------------

As of August 27, 2020, Canada reported over 126,000 cases of COVID-
19 and over 9,000 confirmed deaths.\118\ According to a July 8, 2020
report, repatriated travelers accounted for 13 cases and no deaths. The
Canadian government believes community transmission (as opposed to
cross-border transmission) accounts for 85% of cases. In response to
persistent, low levels of community transmission, authorities in
Toronto, Ottawa, and several other Ontario cities have mandated indoor
mask use. Quebec has similarly announced that masks will be mandatory
in all indoor public places starting July 27, 2020.
---------------------------------------------------------------------------

\118\ Statement from the Chief Public Health Officer of Canada
On August 27, 2020, Gov't of Can., https://www.canada.ca/en/public-health/news/2020/08/statement-from-the-chief-public-health-officer-of-canada-on-august-27-2020.html (last updated August 27, 2020).
---------------------------------------------------------------------------

While Canada was slower to implement public health restrictions on
international travel than the United States, Canada's restrictions are
robust. By closing its border to all but essential travel with the
United States and returning citizens, Canada has operationalized a
self-quarantine process for arriving travelers that has mitigated the
spread of COVID-19, particularly from arriving asymptomatic persons who
are capable of transmitting the disease. Coupled with public health
interventions, Canada's border control measures have led to a
considerable reduction in COVID-19 transmission. The Canadian
experience is further corroboration that this final rule is good policy
and vital to CDC's ability to protection public health in the United
States.

C. This Rulemaking Finalizes Procedures Necessary for HHS/CDC's
Continued Protection of U.S. Public Health From the COVID-19 Pandemic
and Future Threats

HHS/CDC needs this final rule to implement section 362 of the PHS
Act because the IFR is not permanent. ``Unless extended after
consideration of submitted comments, [the IFR] will cease to be in
effect on the earlier of (1) one year from the publication of [the
IFR], or (2) when the HHS Secretary determines there is no longer a
need for [the IFR].'' \119\ Absent such a determination, the IFR lapses
by its own terms on March 20, 2021.
---------------------------------------------------------------------------

\119\ 85 FR 16559 (March 24, 2020).
---------------------------------------------------------------------------

There are also legal actions challenging the IFR. For example, in
P.J.E.S. v. Wolf, No. 20-cv-02245-EGS (D.D.C. filed Aug. 14, 2020), the
named plaintiff has sued the HHS Secretary, the CDC Director, and
others on behalf of a putative class of unaccompanied alien children.
In additional to arguing that the CDC Order and the underlying IFR are
contrary to statute, the putative class representative alleges that the
IFR and CDC Order are arbitrary and capricious for a number of reasons.
According to the named plaintiff, ``Defendants have not articulated a
reasoned explanation for their decision to apply [the IFR and the CDC
Order] to unaccompanied children; failed to consider relevant factors
in applying [the IFR and the CDC Order] to them . . .; relied on
factors Congress did not intend to be considered; failed to consider
reasonable alternatives that were less restrictive; and offered no
sufficient explanation for their decision to expel them from the
country.'' \120\ While the Government is defending all challenges to
the IFR and the CDC

[[Page 56438]]

Order, it is nonetheless possible that a district court could vacate or
enjoin the IFR before the IFR lapses by its own terms on March 20,
2021.
---------------------------------------------------------------------------

\120\ P.J.E.S. v. Wolf, No. 20-cv-02245-EGS, at *27-28 (D.D.C.
Aug. 14, 2020), ECF No. 1.
---------------------------------------------------------------------------

The procedures finalized here ensure that HHS/CDC can mitigate the
danger of the introduction of COVID-19 into the United States
regardless of whether the IFR is vacated or enjoined, or lapses by its
own terms. The procedures also ensure that HHS/CDC can act quickly to
mitigate the danger of the introduction of other quarantinable
communicable diseases into the United States in the future. As
previously discussed, HHS/CDC cannot predict when it will need to
exercise the Section 362 authority in the future; the immediate
availability of procedures for exercising the authority is important
once HHS/CDC decides to take action.
The public health situation in the U.S.-Mexico border region
highlights the need for the procedures. The COVID-19 pandemic still
presents significant challenges for the States in the region, and
Mexico itself. If the procedures established by the IFR ceased to be
effective, then the CDC Order on covered aliens would likewise cease to
be effective, and the danger of the introduction of COVID-19 into the
States in the U.S.-Mexico border region would increase. The CBP
workforce and the civilian population in the U.S.-Mexico border region
would face an increased risk of infection with COVID-19. The community
transmission of COVID-19, the number of new COVID-19 cases, and the
attendant strain on the healthcare system in the U.S.-Mexico border
region would likely increase as well. The Director assesses that HHS/
CDC can mitigate those consequences so long as the procedures
established by the IFR remain in place.
The Director's assessment takes into account the effectiveness of
the IFR and CDC Order as public health measures, recent trends in
COVID-19 case counts and deaths, the experiences of the States, and the
States' current reopening plans. As previously discussed, the Director
assesses that the IFR and CDC Order have reduced the danger of the
introduction of COVID-19 into the United States, and reduced the strain
on the healthcare system in the U.S.-Mexico border region by decreasing
the utilization of the healthcare system by covered aliens. The
Director further assesses that the IFR and CDC Order have helped slow
community transmission of COVID-19 and the number of new COVID-19 cases
in the States in the U.S.-Mexico border region. While these positive
impacts are difficult to quantify, it is undisputed that Mexico has
experienced community transmission for many months, the IFR and CDC
Order enabled DHS to expel tens of thousands of covered aliens from
Mexico who would have otherwise spent material amounts of time in
congregate settings, and large numbers of those covered aliens would
have otherwise been released into the States in the U.S.-Mexico border
region. Given the sheer volume of covered aliens subject to the CDC
Order, the Director assesses that the positive impacts of the IFR and
CDC Order on community transmission and case counts in the U.S.-Mexico
border region were not insubstantial.
The benefits of the IFR and CDC Order are compelling when the
recent trends in COVID-19 case counts and deaths, and the recent
experiences of the States in the U.S.-Mexico border region, are
considered. Nationally, the numbers of COVID-19 cases have continued to
decrease since mid-July, and as of August 22, 2020, six out of ten HHS
surveillance regions reported decreasing or stable levels of the
disease.\121\ Two regions reported an increase in the percentage of
people testing positive for COVID-19, and two regions reported
increases in influenza-like illness visits over the previous week.\122\
Deaths involving COVID-19, pneumonia, and influenza have declined, from
a high of 16,957 deaths during the week ending on April 18, 2020, to
400 deaths during the week ending on August 22, 2020.\123\ Weekly
hospitalizations associated with confirmed COVID-19 cases are also
down, from a high of 10.10 per 100,000 Americans in April, to a low of
2.8 per 100,000 Americans during the week ending on August 22,
2020.\124\
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\121\ COVID View: A Weekly Summary of U.S. COVID-19 Activity
(August 22, 2020), Ctrs. for Disease Control & Prevention, https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html
(last updated Aug. 28, 2020).
\122\ Id.
\123\ Weekly Updates by Select Demographic and Geographic
Characteristics: Provisional Death Counts for Coronavirus Disease
2019 (COVID-19), Ctrs. for Disease Control & Prevention, https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm (last updated Aug.
26, 2020).
\124\ Laboratory-Confirmed COVID-19-Associated Hospitalizations:
Preliminary weekly rates as of Aug. 1, 2020, Ctr. for Disease
Control & Prevention, https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html (last visited Aug. 31, 2020).
---------------------------------------------------------------------------

While hospitalizations and deaths have declined overall, the number
of new COVID-19 cases in certain areas of the country has surged in
recent months. Those areas include the States in the U.S.-Mexico border
region. Indeed, as of August 30, 2020, California and Texas lead the
country with the highest 7-day case count, and Arizona has the third
highest number of cases per 100,000 people over that same period.\125\
---------------------------------------------------------------------------

\125\ United States COVID-19 Cases and Deaths by State: Cases in
Last 7 Days, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/covid-data-tracker/#cases (last updated Aug. 30, 2020)
(California reported 36,947 cases and Texas reported 33,391 cases,
followed by Florida with 20,923 cases; Arizona had the third highest
case rate per 100,000 people in the United States with 2,807 cases,
surpassed only by Louisiana and Florida).
---------------------------------------------------------------------------

The surge in California was dramatic. In early July 2020, the
statewide data in California demonstrated a significant increase in the
community transmission of COVID-19, which prompted State officials to
implement sweeping measures to protect the health of the public.\126\
The State Public Health Officer and Director observed that ``[i]n
addition to the impact on the general population, community spread
increases the likelihood of expanded transmission of COVID-19 in
congregate settings such as nursing homes, homeless shelters, jails and
prisons. Infection of these vulnerable populations in these settings
can be catastrophic[ ].'' \127\ The number of patients hospitalized in
California due to COVID-19 increased between 50-100% in all regions in
the State, with an average increase of 77% compared to mid-June.\128\
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\126\ On July 13, 2020, the California State Public Health
Officer and Director announced mandatory statewide closures of
indoor operations for certain sectors, and both indoor and outdoor
operations for bars and similar establishments Guidance on Closure
of Sectors in Response to COVID-19 (July 13, 2020), Cal. Dep't of
Pub. Health, https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/Guidance-of-Closure-of-Sectors-in-Response-to-COVID-19.aspx (last
updated July 17, 2020). In her order, she observed that ``[t]he data
is clear that community spread of infection is of increasing concern
across the state, and continues to grow in those counties on the
County Monitoring List[,]'' and ``[w]hile these counties [with high
numbers of COVID-19 hospitalizations] are primarily located in the
south and central valley, there are now counties on the monitoring
list from all regions of California.'' See also Blueprint for a
Safer Economy, Cal. All, https://covid19.ca.gov/safer-economy/#top
(last visited Aug. 31, 2020).
\127\ Guidance on Closure of Sectors in Response to COVID-19
(July 13, 2020), Cal. Dep't of Pub. Health, https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/Guidance-of-Closure-of-Sectors-in-Response-to-COVID-19.aspx (last updated July 17, 2020).
\128\ Id.
---------------------------------------------------------------------------

During the California surge, CBP continued to apprehend covered
aliens who had crossed the border from Mexico into California. Absent
the IFR and CDC Order, covered aliens moving through congregate areas
in Border Patrol stations and POEs in California could have been
capable of transmitting the virus that causes COVID-19, thereby
increasing the already serious danger of the introduction of COVID-19
into California and, by extension,

[[Page 56439]]

community transmission in California. The consequences for the
healthcare system in California could have been severe; a surge of
infected covered aliens coming from Mexico could have further reduced
the available inpatient hospital bed capacity in California, while
increasing the exposure of California healthcare workers and the CBP
workforce to COVID-19. Increased community transmission from covered
aliens would have been contrary to the interest of U.S. public health,
and would have frustrated the efforts of Californians to slow community
transmission.
There are still high rates of community spread within California,
though the situation has improved some since the peak of the surge in
July 2020.\129\ California's revised reopening guidelines explain that
as of August 31, 2020, certain businesses will be able to open ``with
modifications, including all retail, shopping centers at maximum 25%
capacity, and hair salons and barbershops indoors,'' even in counties
where community transmission is classified as ``widespread.'' \130\ As
counties step down from ``widespread'' to the ``substantial,''
``moderate,'' or ``minimal'' tiers based on case and positivity rates,
restrictions are progressively loosened, permitting the reopening of
additional indoor businesses and in-person instruction in schools.\131\
Higher rates of community transmission reverse such progress: ``[i]f a
county's metrics worsen for two consecutive weeks, it will be assigned
a more restrictive tier.'' \132\
---------------------------------------------------------------------------

\129\ California Coronavirus Map and Case Count, N.Y. Times,
https://www.nytimes.com/interactive/2020/us/california-coronavirus-cases.html (last visited Aug. 31, 2020).
\130\ Blueprint for a Safer Economy, Cal. All, https://covid19.ca.gov/safer-economy/#top (last visited Aug. 31, 2020).
\131\ Id.
\132\ See id.
---------------------------------------------------------------------------

While California is making progress, it is not in the clear yet. As
of August 30, 2020, the California Department of Health reported
699,909 confirmed cases of COVID-19, and 12,905 deaths. It recognized
that ``[a]s case numbers continue to rise in California, the total
number of individuals who have serious outcomes will also increase.''
\133\
---------------------------------------------------------------------------

\133\ State Officials Anounce Latest COVID-19 Facts, Cal. Dep't.
of Pub. Health, https://www.cdph.ca.gov/Programs/OPA/Pages/NR20-213.aspx (last updated Aug. 30, 2020).
---------------------------------------------------------------------------

The Director assesses that increased community transmission in
California would likely result in increased numbers of cases, as well
as increased case and positivity rates, and ultimately increased
numbers of individuals who have serious outcomes. Increases in case and
positivity rates would, in turn, frustrate efforts by California
counties to step down to lower tiers in the reopening guidelines and
begin in-person schooling and the reopening of businesses. The Director
further assesses that the introduction of covered aliens into
California through congregate settings in CBP facilities would likely
have a negative impact on case and positivity rates in California,
which would not be in the interest of U.S. public health.
Similar to California, Arizona saw significant increases in the
number of confirmed COVID-19 infections beginning in mid-May, leading
the Governor of Arizona to suspend the State's phased re-opening plans
and delay the phased reopening of schools until August 17, 2020.\134\
The Federal government committed to constructing surge testing sites in
Arizona to help meet the increased demand for diagnostic testing.\135\
During mid-June, Arizona was averaging approximately 1,300 new COVID-19
infections a day; \136\ and by mid-July, Arizona had one of the highest
positivity rates in the nation, at nearly 27%.\137\ By July 27, 2020,
10 out of the 14 counties in Arizona were in the ``red zone,'' meaning
there were more than 100 new cases for every 100,000 people, and more
than 10% of the people tested for COVID-19 test positive.\138\
---------------------------------------------------------------------------

\134\ Press Release, Governor of Arizona Announces Further
Action to Reverse COVID-19 Spread in the State (June 29, 2020)
(available at: https://azgovernor.gov/governor/news/2020/06/further-action-reverse-covid-19-spread-arizona).
\135\ Jessica Boehm, Ariz. Cent., Feds downplay Phoenix mayor's
COVID-19 testing concerns, but commit to new mass test site in west
Phoenix (July 8, 2020), https://www.azcentral.com/story/news/local/phoenix/2020/07/08/feds-discount-gallego-concerns-but-commit-covid-19-testing-site/5400030002/.
\136\ Will Stone, Health Experts Link Rise in Arizona
Coronavirus Cases to End of Stay-At-Home Order, Nat'l Pub. Radio
(June 14, 2020), https://www.npr.org/2020/06/14/876786952/health-experts-link-rise-in-arizona-coronavirus-cases-to-end-of-stay-at-home-ord.
\137\ Arizona's surge in coronavirus cases has been ``the worst
in the entire country,'' health experts say, CBS News (July 13,
2020), https://www.cbsnews.com/news/arizona-coronavirus-cases-worst-in-united-states.
\138\ State Reports, White House Coronavirus Task Force, *17-23
(July 26, 2020) (on file with HHS).
---------------------------------------------------------------------------

As a result of the surge in new COVID-19 cases, Arizona's
healthcare system approached capacity in terms of the number of
available hospital beds and critical staff.\139\ On July 1, 2020,
Arizona requested 500 additional medical personnel from FEMA, in
addition to the 62 Federal medical personnel already deployed to assist
with Arizona's COVID-19 response.\140\ On July 1, in response to a
petition from medical providers, the Arizona Department of Health
Services activated the State's Crisis Standards of Care Plan, which
establishes guidelines for the allocation of scarce healthcare
resources among patients based on factors such as likelihood of
survival.\141\ As of August 30, 2020, Arizona's inpatient hospital bed
occupancy rate was still approximately 81%, with approximately 10%
occupied by COVID-19 patients; and its ICU bed occupancy rate was
approximately 77%, with approximately 15% occupied by COVID-19
patients.\142\
---------------------------------------------------------------------------

\139\ Id. See Data Dashboard, Ariz. Dep't of Health Serv.'s,
https://www.azdhs.gov/preparedness/epidemiology-disease-control/infectious-disease-epidemiology/covid-19/dashboards/index.php (last
visited Aug. 31, 2020) (see ``Hospital Bed Usage & Availability''
tab).
\140\ See Vice President Pence Holds News Conference with
Arizona Governor, C-SPAN (July 1, 2020), https://www.c-span.org/video/?473590-1/vice-president-urges-wearing-masks-amid-coronavirus-spike-arizona (statements regarding FEMA medical personnel occur at
03:52-04:20); see also Brett Samuels, Arizona asks for 500
additional medical personnel amid spike in virus cases, The Hill
(July 1, 2020), https://thehill.com/homenews/state-watch/505517-arizona-asks-for-500-additional-medical-personnel-amid-spike-in-virus.
\141\ See generally COVID-19 Implementing Crisis Standards of
Care at Short-Term Inpatient Acute Care Facilities Guidance Approved
by State Disaster Medical Advisory Committee (SDMAC)--4/1/2020,
Ariz. Dep't of Health Serv.'s, (available at: https://www.azdhs.gov/documents/preparedness/epidemiology-disease-control/infectious-disease-epidemiology/novel-coronavirus/sdmac/sdmac-guidance-crisis-standards-care-healthcare-facilities.pdf); Arizona Crisis Standards
of Care Plan, 3d ed. (2020), Ariz. Dep't of Health Serv.'s,
(available at: https://www.azdhs.gov/documents/preparedness/emergency-preparedness/response-plans/azcsc-plan.pdf).
\142\ Data Dashboard, Ariz. Dep't of Health Serv.'s, https://www.azdhs.gov/preparedness/epidemiology-disease-control/infectious-disease-epidemiology/covid-19/dashboards/index.php (last visited
Aug. 13, 2020) (see ``Hospital Bed Usage & Availability'' tab,
subtabs for ``ICU Bed Usage and Availability'' and ``Inpatient Bed
Usage and Availability'').
---------------------------------------------------------------------------

Arizona has instituted county-specific public health benchmarks
that must be achieved in order to begin the phased reopening of
businesses, including bars, indoor gyms/fitness centers, indoor movie
theaters, and water parks/tubing operations.\143\ Under the benchmark
system, businesses in counties designated as experiencing minimal or
moderate transmission, as indicated by certain metrics for at least two
weeks, may reopen subject to occupancy limits and other mitigation
requirements.\144\ As of August 27, 2020, only one county is
experiencing minimal transmission, eight counties are experiencing
moderate transmission, and six counties

[[Page 56440]]

are experiencing substantial transmission, during which all businesses
must remained closed.\145\
---------------------------------------------------------------------------

\143\ See Benchmarks for Businesses by County, Ariz. Dep't of
Health Serv.'s, (available at https://www.azdhs.gov/documents/preparedness/epidemiology-disease-control/infectious-disease-epidemiology/novel-coronavirus/business-benchmarks.pdf) (last
updated Aug. 27, 2020).
\144\ Id.
\145\ Id.
---------------------------------------------------------------------------

The Director assesses that the IFR and CDC Order have helped
protect the overtaxed Arizona healthcare system from additional strain
and conserve health care resources for the domestic population. The
Director further assesses that absent the IFR and CDC Order, covered
aliens moving through congregate settings in CBP facilities in Arizona
could have been capable of transmitting the virus that causes COVID-19,
thereby increasing the already serious danger of the introduction of
COVID-19 into Arizona and, by extension, community transmission in
Arizona. The additional strain on the system would have been
problematic because the situation in Arizona has been serious, with
hospital occupancy rates nearing limits, critical staff shortages, and
the activation of State plans for allocating health care.
As with California, the Director assesses that increased community
transmission in Arizona would likely result in increased numbers of
cases, as well as increased case and positivity rates, and ultimately
increased numbers of individuals who have serious outcomes. Increases
in case and positivity rates would, in turn, frustrate efforts by
Arizona counties to meet benchmarks for the reopening of businesses.
The Director assesses that the introduction of covered aliens into
Arizona through congregate settings in CBP facilities would likely have
a negative impact on case and positivity rates in Arizona, which would
not be in the interest of U.S. public health.
The Director's concerns are driven partly by the public health
situation in Mexico. As of August 31, 2020, Mexico has 591,712
confirmed cases, and 63,819 reported deaths.\146\ Some observers
believe the actual COVID infections and deaths are multiples (likely
between 10 to 20 times) of what is reported, as Mexico has the lowest
diagnostic testing per capita of any country in the Organization for
Economic Co-operation and Development (OECD).\147\
---------------------------------------------------------------------------

\146\ WHO Coronavirus Disease (COVID-19) Dashboard, WHO, https://covid19.who.int/table (last visited Aug. 31, 2020).
\147\ Azam Ahmed, Hidden Toll: Mexico Ignores Wave of
Coronavirus Death in Capital, The N.Y. Times (May 8, 2020, updated
May 28, 2020), https://www.nytimes.com/2020/05/08/world/americas/mexico-coronavirus-count.html.
---------------------------------------------------------------------------

While the data on Mexico is limited, there are signs that the
epicenter of the COVID-19 pandemic in Mexico is shifting from Mexico
City to the Mexican border states as the overall public health
situation improves somewhat. As of August 28, 2020, under SALUD's
``stoplight'' designation system, only one of Mexico's 32 states,
Colima, is red, 21 are orange, and 10 are yellow. Five states advanced
to orange from red. According to SALUD, Mexico City's cases are
stabilizing and hospital occupancy in the city decreased to 47 percent,
from a high of approximately 80 percent in mid-June. Although hospital
occupancy rates have improved in recent weeks--the national hospital
occupancy rate is 36 percent--hospital occupancy rates remain elevated
in Mexican border states such as Nuevo Leon (61 percent) and Coahuila
(48 percent). As of August 26, 2020, several Mexican border states
report relatively high numbers of active COVID-19 infections:
Tamaulipas (3,566 active cases), Nuevo Leon (6,028 actives cases) and
Baja California (1,440 active cases). On August 2, 2020, the health
minister of the Mexican border State of Chihuahua died from COVID-19
after nearly two weeks of inpatient hospitalization.\148\
---------------------------------------------------------------------------

\148\ Laura Gottesdieer, Mexican State health minister dies
after being hospitalized for COVID-19, Reuters (July 26, 2020, 11:57
a.m.), https://www.reuters.com/article/us-health-coronavirus-mexico-idUSKCN24R0K5.
---------------------------------------------------------------------------

A shift in the epicenter of the COVID-19 pandemic in Mexico to the
U.S.-Mexico border region would present increased concerns for U.S.
public health because all covered aliens crossing the U.S.-Mexico
border necessarily travel through that region. If community
transmission in the Mexican border region increases, then the numbers
of COVID-19 cases in that region are likely to increase, as are the
numbers of infected covered aliens who seek to introduce themselves
into the United States. The introduction of more infected covered
aliens would probably have a negative impact on community transmission
in the United States, and ultimately U.S. public health.

III. Statutory Authority

The primary legal authority supporting this rulemaking is section
362 of the PHS Act, which is codified at 42 U.S.C. 265. Congress
enacted section 362 in 1944, and modeled it on Section 7 of the
Quarantine Act of 1893, which was informed by U.S. public health laws
from the early days of the Republic. The history of the U.S. public
health laws is a helpful backdrop when analyzing the congressional
intent behind section 362. Below we discuss the history of such laws,
followed by a discussion of section 362 and other relevant statutory
authorities.

A. History of the U.S. Public Health Laws

Congress has long recognized the danger posed by communicable
disease and granted broad powers to the Executive Branch to address the
danger during times of emergency. In 1796, Congress passed an Act
Relative to Quarantine, which authorized the President to direct U.S.
officers to ``aid in the execution of quarantine, and also in the
execution of the health laws of the states, respectively, in such
manner as may to him appear necessary.'' \149\
---------------------------------------------------------------------------

\149\ An Act relative to Quarantine, ch. 31, 1 Stat. 474 (May
27, 1796).
---------------------------------------------------------------------------

After a yellow fever outbreak in New York in 1798, Congress enacted
``An Act Respecting Quarantine and Health Laws.'' \150\ This statute
replaced the Act of May 1796 and created a more robust Federal public
health regime. It authorized and required certain officers to aid in
the execution of State quarantine and health laws, including those with
respect to vessels arriving in or bound to any U.S. port. It also
authorized the Secretary of the Treasury to vary or dispense with
regulations concerning the entry of vessels and cargoes when required
for consistency with quarantine and other health laws. Just as the
Director has recognized the threat that the introduction of COVID-19
presents to CBP personnel, the Act recognized that the ``prevalence of
any contagious or epidemical disease'' at a port could present a danger
to Federal officials. Therefore, it authorized measures to protect
Federal officials during an outbreak. Specifically, it authorized the
Secretary of the Treasury and the President to order the relocation of
revenue officers and public offices, respectively, from a dangerous
port to a safe location.\151\ Almost 100 years later, the U.S.
experienced a severe cholera outbreak caused by persons arriving from
Europe.\152\ In response, Congress passed the Quarantine Act of 1893,
ch. 114, 27 Stat. 449. Several provisions of that Act addressed the
Federal authority to quarantine persons arriving in the United States.
Section 7 of the Act of 1893, which used terms nearly identical to the
current section 362, expanded Federal authority beyond the authority to
quarantine persons. Specifically, it authorized the President to
``prohibit'' the ``introduction'' of persons into the United States if
``the quarantine defense'' was insufficient to address a

[[Page 56441]]

``serious danger of the introduction of the [disease] into the United
States'', and a ``suspension of the right to introduce'' persons or
property was demanded in the interest of public health: [W]henever it
shall be shown to the satisfaction of the President that by reason of
the existence of cholera or other infectious or contagious diseases in
a foreign country there is serious danger of the introduction of the
same into the United States, and that notwithstanding the quarantine
defense this danger is so increased by the introduction of persons or
property from such country that a suspension of the right to introduce
the same is demanded in the interest of the public health, the
President shall have power to prohibit, in whole or in part, the
introduction of persons and property from such countries or places as
he shall designate and for such period of time as he may deem
necessary. 27 Stat. 449, 452 (Feb. 15, 1893).
---------------------------------------------------------------------------

\150\ An Act respecting Quarantine and Health Laws, ch 12, 1
Stat. 619 (Feb. 25, 1799).
\151\ Id.
\152\ History of Quarantine, Ctrs. for Disease Control &
Prevention, https://www.cdc.gov/quarantine/historyquarantine.html
(last updated July 20, 2020).
---------------------------------------------------------------------------

Section 7 was broader than some of the other sections of the Act of
1893 because it applied to the act of introducing a person into the
United States, and not simply to ships or vessels carrying
passengers.\153\ Section 7 prevented individuals traveling aboard
vessels from circumventing vessel-specific prohibitions that focused
solely on disembarkations in American harbors. By allowing the
President to broadly prohibit the ``introduction'' of persons, it
ensured that travelers could not evade the prohibition by swimming or
walking to shore.\154\ Congress also sought to give the Executive
Branch the power to prevent asymptomatic persons infected with a
communicable disease from moving into the country before the
asymptomatic persons and the customs or public health officials could
detect the disease. Such persons, if allowed into the country, would
``disseminate the poison that has been slumbering in their midst and
imperil the lives of any community in which they happen to locate.''
H.R. 9757, 52nd Cong., 2d Sess., Report No. 2210 at 4 (Jan. 9, 1893).
The risk of asymptomatic transmission arose from persons moving into
the United States by vessel, by foot, or by any other any means, and
increased once the person was on U.S. soil and poised to move further
into the country.
---------------------------------------------------------------------------

\153\ Congress repeatedly used ``ship'' or ``vessel'' in other
sections of the 1893 Act, but conspicuously referred more broadly to
``persons or property'' in section 7. Compare The Quarantine Act of
1893, ch. 114, 27 Stat. 449 section 7 with section 1 (unlawful for
ships to enter U.S. ports from abroad except in accordance with
public health regulations); section 2 (requiring ships abroad to
obtain a bill of health); section 3 (authorizing, inter alia,
regulation of ``vessels sail[ing] from any foreign port or place'');
section 5 (issuance of regulations for, inter alia, ``vessels in
foreign ports,'' and prohibition on vessels arriving without a bill
of health); and section 6 (providing for ``an infected vessel'' to
be ``remand[ed]'' to quarantine station). The fact that Congress did
not mention ``ship'' or ``vessel'' in section 7, as it does in the
other sections of the Act, indicates that Congress did not intend to
limit section 7's application to ships.
\154\ Consistent with contemporaneous dictionaries and the
ordinary meaning and usage of ``introduce,'' a person could
``introduce'' him or herself. Introduction of a person was an action
that could be taken by individuals as well as third parties. See
Universal English Dictionary 1067 (John Craig ed. 1861) (defining
``introduction'' to include, inter alia, ``the act of bringing into
a country'' and ``the ushering of a person into presence'');
American Dictionary of the English Language 113 (Noah Webster ed.,
1828) (similar definitions); cf. Ashley v. Bd. of Sup'rs of Presque
Isle Cty., 83 F. 534, 540 (6th Cir. 1897) (referring to a ``party
[who] introduces himself as a witness in his own behalf'') (emphasis
added); Olds Wagon Works v. Benedict, 67 F. 1, 4 (8th Cir. 1895)
(discussing an ``intervener who introduces himself into a pending
action in a state court'') (emphasis added).
---------------------------------------------------------------------------

Section 7 also was noteworthy because it granted the authority to
``suspend'' the ``right to introduce'' persons or property. In 1893, as
now, ``suspend'' was a term of art for temporarily ceasing the
operation or effect of laws. See, e.g., U.S. Const. art. I, sec. 9, cl.
2 (``The Privilege of the Writ of Habeas Corpus shall not be suspended,
unless when in Cases of Rebellion or Invasion the public Safety may
require it.''); see also Universal English Dictionary 815 (John Craig
ed. 1869) (defining ``suspend,'' in part, as ``to cause to cease for a
time from operation or effect, as, to suspend the habeas corpus act'')
(emphasis in original). Unlike the other sections of the Act of 1893,
section 7 used the phrase ``suspension of the right to introduce,''
which by its plain meaning demonstrates that Congress intended for
section 7 to authorize the President to cease temporarily the effect of
any laws conferring a right to introduce persons.\155\
---------------------------------------------------------------------------

\155\ See Universal English Dictionary 815 (John Craig ed. 1869)
(defining ``suspension,'' in part, as ``[t]he act of suspending; the
state of being suspended; in special senses, a keeping in doubt;
postponement of legal execution'').
---------------------------------------------------------------------------

Furthermore, the Congressional record reflects a clear and
consistent theme that section 7 is intended to give the President the
authority to suspend any right to introduce persons that any
immigration laws confer on the Executive Branch. As one Senator
explained:

[I]f section 7 be adopted, then I think it will be quite clear
that . . . the power to suspend immigration altogether, either
temporarily or permanently as a health device, is intended to be
lodged solely in the President of the United States, where it
certainly should be lodged. In other words, if it be true that the
quarantine power involves in it the power of total suspension of
immigration, if we leave the bill without the proposed section 7,
every petty quarantine officer, or certainly the Secretary of the
Treasury, will have it, to which I do not agree. I think it is quite
clear that this section should be added, declaring in terms whenever
the health or protection of the country from infection requires the
total suspension of immigration, that power is to belong to the
President[.]

24 Cong. Rec. 393 (Jan. 7, 1893) (statement of Sen. Hoar); see also id.
at 393-94 (statement of Sen. Chandler) (recognizing that section 7
would give the President the power to suspend immigration in his
discretion, whenever there is danger of infection); 24 Cong. Rec. 470
(Jan. 10, 1893) (statement of Sen. Gray) (stating that the exigency
posed by ``apprehension of the invasion of contagious disease [ ] is
sufficient . . . to justify this extraordinary power of the entire
suspension of immigration'').\156\ The exigency of the cholera outbreak
taught that it was necessary to convey a broad power to the Executive
Branch to use in rare times of emergency to protect public health. As
one Senator put it, ``I believe that our duty is to provide, as far as
our constitutional authority can possibly go, for the prevention of the
introduction of these epidemics. It is a peculiarly binding and
obligatory duty at this time.'' 2 Cong. Rec. 472 (Jan. 10, 1893)
(statement of Sen. Morgan) (emphasis added).
---------------------------------------------------------------------------

\156\ The Act of 1893 passed overwhelmingly with broad
bipartisan support, but even those opposed to the law recognized it
granted the President the authority to suspend immigration. See,
e.g., 24 Cong. Rec. 370-71 (Jan. 6, 1893) (statement of Sen. Mills)
(``I shall vote very cheerfully against placing in the hands of the
President of the United States, whether he be a Republican or a
Democrat, any such extraordinary power as that, to suspend
immigration to this country at his pleasure.'').
---------------------------------------------------------------------------

Congress enacted the Act of 1893 two years after enacting the
Immigration Act of 1891 (``Immigration Act''), which authorized the
Treasury Department to regulate immigration, and excluded from
admission into the United States aliens ``suffering from a loathsome or
a dangerous contagious disease.'' Act of Mar. 3, 1891, ch. 551, section
1, 26 Stat. 1084. Section 8 of the Immigration Act authorized
inspection officers from the Treasury Department to board any arriving
vessel, inspect the aliens on the vessel, and have surgeons conduct
medical examinations of the aliens. Section 9 imposed a penalty on any
person or transportation company bringing to the United States any
alien ``suffering from a loathsome or dangerous contagious disease.''
When Congress enacted section 7 of the Act of 1893, Congress was
fully

[[Page 56442]]

aware of the Immigration Act that it had enacted just two years
earlier. The Act of 1893 was not a redundant immigration law. It was a
broad public health statute that gave the President a sweeping but
temporary power to combat larger, global threats to public health.
Congress intended for the power to prohibit the introduction of persons
to be a categorical one that operates separately and independently of
the immigration power that applies against individual aliens suffering
from a contagious disease. Congress recognized that this separate
public health authority was needed to address, among other things,
situations where an infected but asymptomatic person was seeking
introduction into the United States, or government resources were
overtaxed.
In June 1929, President Herbert Hoover issued an Executive Order
invoking section 7 of the Act of 1893 to restrict the ``Transportation
of Passengers'' from China and the Philippines because of a meningitis
outbreak.\157\ Since November 1928, 17 trans-Pacific passenger-carrying
vessels with epidemic cerebrospinal meningitis infections on board had
arrived at U.S. Pacific coast ports. The continued arrival of
passengers with cerebrospinal meningitis infection had ``overtaxed''
Federal and state quarantine facilities, and ``notwithstanding the
quarantine defense, there exist[ed] danger of introducing this disease
into the United States[.]'' \158\ Therefore, ``in order to prevent the
further introduction'' of cerebrospinal meningitis into the United
States, the Executive Order provided that no persons may be introduced
directly or indirectly by transshipment or otherwise into the United
States or any of its possessions or dependencies from any port in China
(including Hong Kong) or the Philippine Islands for such period of time
as may be deemed necessary, except under such conditions as may be
prescribed by the Secretary of the Treasury.\159\
---------------------------------------------------------------------------

\157\ Exec. Order No. 5143 (June 21, 1929).
\158\ Id.
\159\ Id.
---------------------------------------------------------------------------

Although the Executive Order focused on vessels, it was not limited
to them; it clearly stated that ``no persons may be introduced directly
or indirectly by transshipment or otherwise into the United States,''
except as permitted by the Treasury Secretary (emphasis added). The
regulations accompanying the Executive Order did not purport to narrow
the Executive Order or foreclose the Executive Branch from enforcing
section 7 of the Act of 1893 against symptomatic or asymptomatic
persons from China or the Philippines who introduced themselves into
the United States by swimming or walking ashore.\160\ The Executive
Order tailored the Federal response to a discrete problem: The arrival
at Pacific Coast ports of trans-pacific passenger-carrying vessels with
epidemic cerebrospinal meningitis infection existing on board. Neither
the Executive Order nor the accompanying regulations purported to set
forth a comprehensive or final interpretation or framework for the
implementation of section 7 of the Act of 1893. President Hoover's
Executive Order was consistent with the statutory text, which
communicates clearly that the authority to prohibit the introduction of
persons is not limited to any one communicable disease, setting, mode
of introduction, or geographic location.
---------------------------------------------------------------------------

\160\ See Regulations Governing Embarkation of Passengers and
Crew at Ports in China and the Philippine Islands and Their
Transportation to the United States Ports Prescribed in Accordance
with Executive Order Approved June 21, 1929 (July 11, 1929),
included in Conn. Dep't of Health, Connecticut Health Bulletin, vol.
43. No. 9, 324-326 (Sep. 1929).
---------------------------------------------------------------------------

In 1944, Congress enacted section 362 of the PHS Act. 42 U.S.C.
265. Section 362 is nearly identical to section 7 of the 1893 Act.

Whenever the Surgeon General determines that by reason of the existence
of any communicable disease in a foreign country there is serious
danger of the introduction of such disease into the United States, and
that this danger is so increased by the introduction of persons or
property from such country that a suspension of the right to introduce
such persons and property is required in the interest of the public
health, the Surgeon General, in accordance with regulations approved by
the President, shall have the power to prohibit, in whole or in part,
the introduction of persons and property from such countries or places
as he shall designate in order to avert such danger, and for such
period of time as he may deem necessary for such purpose.
The legislative history of section 362 indicates that it was
largely intended to reenact section 7 of the 1893 Act. As explained in
a house report, ``Section 362 would reenact a provision of present law
(42 U.S.C. 111) authorizing the suspension of travel of persons and
shipment of goods from any foreign country where a communicable disease
exists, if there is found to be serious danger of introduction of the
disease into the United States. Consistently with the general
administrative pattern in the bill, the authority now lodged in the
President would be placed in the Surgeon General, to be exercised under
Presidential regulations.'' H.R. Rep. No. 78-1364, at 25 (1944).
The differences between section 7 and section 362 are few. First,
section 362 grants authority to the Surgeon General (not the
President). Second, it applies to any ``communicable disease'' (not
``cholera or other infectious or contagious diseases''). Third, it
omits the phrase ``notwithstanding the quarantine defense.'' Fourth, it
authorizes the Surgeon General to suspend the right to introduce when
it is ``required'' (not ``demanded'') in the interest of public health.
Congress's omission of the phrase ``notwithstanding the quarantine
defense'' reinforced Congress's intent that the Executive Branch have
the flexibility to prohibit the introduction of persons in situations
both where quarantine is available as a public health measure, and
where it is not. Originally, section 7 of the Act of 1893 linked the
authority to prohibit the introduction of persons to the inadequacy of
quarantine as a national defense against disease transmission. By
decoupling the prohibition of the introduction of persons from the
inadequacy of quarantine, Congress gave the Surgeon General even
greater flexibility to prohibit the introduction of persons into the
United States in the interest of public health, by allowing that power
to be exercised regardless of whether the government is exercising its
quarantine powers, and regardless of the adequacy of any quarantine
measures. This statutory change followed the meningitis outbreak of
1929, during which President Hoover prohibited the introduction of
persons arriving from Asia when Federal and local quarantine facilities
were operational but overtaxed.\161\
---------------------------------------------------------------------------

\161\ Exec. Order No. 5143 (June 21, 1929).
---------------------------------------------------------------------------

The current statutory text therefore expressly gives the Director
the authority to ``prohibit, in whole or in part, the introduction of
persons'' from foreign countries whenever he determines there is a
serious danger of the introduction of a communicable disease into the
United States and that this danger is so increased by the introduction
of persons from those countries that a ``suspension of the right to
introduce persons'' is required in the interest of public health. The
statute is not limited to any particular communicable disease, setting,
mode of introduction, or geographic location.

[[Page 56443]]

B. Other Statutory Authorities Relevant to This Rulemaking

In addition to section 362, other sections of the PHS Act are
relevant to this rulemaking, including section 311, 42 U.S.C. 243;
section 361, 42 U.S.C. 264; section 365, 42 U.S.C. 268; section 367, 42
U.S.C. 270, and section 368, 42 U.S.C. 271.
Section 311 authorizes the Secretary to accept State and local
assistance in the enforcement of quarantine rules and regulations and
to assist the States and their political subdivisions in the control of
communicable diseases. 42 U.S.C. 243(a).
As previously discussed, section 361 authorizes the Secretary to
make and enforce such regulations that in the Secretary's judgment are
necessary to prevent the introduction, transmission, or spread of
communicable diseases from foreign countries into the United States. 42
U.S.C. 264(a). It also permits the apprehension, detention, or
conditional release of individuals in order to prevent the
introduction, transmission, or spread of such communicable diseases as
may be specified from time to time in Executive Orders of the President
upon the recommendation of the Secretary, in consultation with the
Surgeon General. 42 U.S.C. 264(b).
Section 365 provides that it shall be the duty of customs officers
and of Coast Guard officers to aid in the enforcement of quarantine
rules and regulations.\162\ 42 U.S.C. 268(b). Under Section 365, Coast
Guard officers have aided in the apprehension and detention of
individuals for purposes of quarantine and isolation, particularly at
U.S. ports of entry. They have also enforced CDC's No Sail Order with
respect to certain cruise ships.\163\ Additionally, the customs
officers from DHS have assisted CDC in implementing the CDC Order on
covered aliens.
---------------------------------------------------------------------------

\162\ The terms ``officer of the customs'' and ``customs
officer'' are defined by statute to mean, ``any officer of the
United States Customs Service of the Treasury Department (also
hereinafter referred to as the ``Customs Service'') or any
commissioned, warrant, or petty officer of the Coast Guard, or any
agent or other person, including foreign law enforcement officers,
authorized by law or designated by the Secretary of the Treasury to
perform any duties of an officer of the Customs Service.'' 19 U.S.C.
Sec. 1401(i). Although this provision refers to the Secretary of the
Treasury, the Homeland Security Act transferred to the Secretary of
Homeland Security all ``the functions, personnel, assets, and
liabilities of . . . the United States Customs Service of the
Department of the Treasury, including the functions of the Secretary
of the Treasury relating thereto . . . [,]'' 6 U.S.C. Sec. 203(1),
such that reference to the Secretary of the Treasury should be read
to reference the Secretary of Homeland Security.
\163\ See No Sail Order and Suspension of Further Embarkation,
85 FR 16628, 16631 (Mar. 24, 2020); No Sail Order and Suspension of
Further Embarkation; Notice of Modification and Extension and Other
Measures Related to Operations, 85 FR 21004, 21007 (Apr. 15, 2020).
---------------------------------------------------------------------------

The vesting in DHS of a duty to aid HHS/CDC in the enforcement of
rules and regulations promulgated under section 362 is critical to the
functioning of the PHS Act because DHS has personnel and resources at
the operational level that HHS/CDC may require to execute a prohibition
on the introduction of persons into the United States. HHS/CDC, for
example, does not have officers at POEs who can avert dangers to public
health by taking into Federal custody and expelling persons who seek to
introduce themselves into the United States in violation of a CDC
Order. Nor does HHS/CDC have the operational capability to avert
dangers to public health by interdicting vessels that seek to introduce
persons into the United States or people who attempt to enter into the
United States between ports of entry in violation of a CDC Order. HHS/
CDC, like its predecessor agencies and public health agencies at the
state level, depends partly on law enforcement agencies with
operational capabilities to avert dangers to public health by enforcing
HHS/CDC's public health orders against those who seek to violate them.
Section 368 provides that any person who violates regulations
implementing sections 361 or 362 will be subjected to a fine or
imprisonment for not more than one year, or both. Pursuant to 18 U.S.C.
3559 and 3571, an individual may face a fine of up to $100,000 for a
violation not resulting in death, and up to $250,000 for a violation
resulting in death. Under section 368, HHS/CDC may refer violators to
the U.S. Department of Justice for criminal prosecution. HHS/CDC does
not have independent authority under section 368 to impose criminal
fines or imprison violators.

IV. Provisions of New Section 71.40 and Changes From Interim Final Rule

This final rule will interpret and implement section 362 and other
applicable provisions of the PHS Act to enable the Director to prohibit
the introduction of persons into the United States consistent with the
statute and applicable law.
There are a few notable changes between this final rule and the
IFR. First, this final rule has a slightly different name from the IFR,
which was titled ``Control of Communicable Diseases; Foreign
Quarantine: Suspension of Introduction of Persons Into the United
States From Designated Foreign Countries or Places for Public Health
Purposes.'' HHS/CDC decided to change the name of the final rule to
``Control of Communicable Diseases; Foreign Quarantine: Suspension of
the Right to Introduce and Prohibition of Introduction of Persons into
United States from Designated Foreign Countries or Places for Public
Health Purposes'' to better align with the text of section 362, which
uses the phrase ``suspension of the right to introduce'' and states
that the Director shall have ``the power to prohibit . . . the
introduction of persons.''
Second, the final rule uses the term ``quarantinable communicable
disease'' instead of ``communicable disease.'' The purpose of this
change is to clarify that these procedures do not apply to all
communicable diseases. Instead, these procedures are limited to
preventing the introduction of quarantinable communicable diseases,
which are included in the ``Revised List of Quarantinable Communicable
Diseases'' found in Executive Order 13295, as amended by Executive
Order 13375 and Executive Order 13674.\164\ The current list of
diseases includes cholera, diphtheria, infectious tuberculosis, plague,
smallpox, yellow fever, viral hemorrhagic fevers (including Lassa,
Marburg, Ebola, Crimean-Congo, South American, and others not yet
isolated or named), severe acute respiratory syndromes (including
Middle East Respiratory Syndrome and COVID-19), and influenza caused by
novel or reemergent influenza viruses that are causing, or have the
potential to cause a pandemic.
---------------------------------------------------------------------------

\164\ Exec. Order 13295 (Apr. 4, 2003), as amended by Exec.
Order 13375 (Apr. 1, 2005) and Exec. Order 13674 (July 31, 2014).
---------------------------------------------------------------------------

Third, the final rule adds in section 71.40(c) the requirement that
the Director include in his or her Order a statement of ``the serious
danger posed by the introduction of the quarantinable communicable
disease in the foreign country or countries (or one or more designated
political subdivisions or regions thereof) or places from which the
introduction of persons is being prohibited.'' After considering
comments (infra section V.), HHS/CDC decided to add this requirement
because HHS/CDC agrees that the Director ought to provide the public
with a short and concise factual statement on the serious danger of the
introduction of the quarantinable communicable disease that justifies
the exercise of those powers. For similar reasons, this final rule also
adds that any order issued pursuant to it shall state the means by
which the prohibition on introduction shall be implemented.

[[Page 56444]]

Finally, HHS/CDC is changing the use of the word ``vector'' in the
definition of ``suspension of the right to introduce.'' While the term
``vector'' may technically include humans in some definitions, it is
generally accepted in the scientific community that vectors are living
organisms that can transmit infectious diseases between humans or to
humans from animals, such as mosquitoes, ticks, flies, and fleas, among
others. There is not an equivalent term that applies specifically to
humans.

A. Section 71.40(a)

As discussed previously, Section 362 of the PHS Act requires that
the Director first ``determine [[hairsp]] that by reason of the
existence of any communicable disease in a foreign country there is a
serious danger of the introduction of such disease into the United
States, and that this danger is so increased by the introduction of
such persons . . . from such country that a suspension of the right to
introduce such persons . . . is required in the interest of the public
health . . . .'' Only then ``shall [the Director] have the power to
prohibit, in whole or in part, the introduction of persons . . . from
such countries or places as he shall designate in order to avert such
danger, and for such period of time as he may deem necessary for such
purpose.''
Section 71.40(a) interprets and implements the requirements in
section 362 that the Director must fulfill in order to prohibit the
introduction of persons into the United States. Specifically, section
71.40(a) establishes that the Director may prohibit, in whole or in
part, the introduction into the United States of persons from
designated foreign countries (or one or more political subdivisions or
regions thereof) or places, only for such period of time that the
Director deems necessary to avert the serious danger of the
introduction of a quarantinable communicable disease by issuing an
order in which the Director determines that:
(1) By reason of the existence of any quarantinable communicable
disease in a foreign country (or one or more political subdivisions or
regions thereof) or place there is serious danger of the introduction
of such quarantinable communicable disease into the United States, and
(2) This danger is so increased by the introduction of persons from
such country (or one or more political subdivisions or regions thereof)
or place that a suspension of the right to introduce such persons into
the United States is required in the interest of public health.
In this final rule, HHS/CDC adds to section 71.40(a) that the
prohibition on the introduction into the United States of persons from
designated foreign countries (or one or more political subdivisions or
regions thereof) or places may be done ``in whole or in part.'' The
phrase ``in whole or in part'' appears in section 362, so HHS/CDC
believes it is appropriate to include it in the final rule. The
authority to prohibit the introduction of persons into the United
States is a broad one, and HHS/CDC will tailor its use of the authority
to what is required in the interest of public health. If HHS/CDC
concludes that public health requires only a prohibition on the
introduction of certain persons from foreign countries (or one or more
political subdivisions or regions thereof) or places, then HHS/CDC will
not prohibit the introduction of all persons from such countries or
places.
HHS/CDC may, in its discretion, consider a wide array of facts and
circumstances when determining what is required in the interest of
public health in a particular situation. Those facts and circumstances
may include the same ones that HHS/CDC considers when issuing travel
health notices: The overall number of cases of disease; any large
increase in the number of cases over a short period of time; the
geographic distribution of cases; any sustained (generational)
transmission; the method of disease transmission; morbidity and
mortality associated with the disease; the effectiveness of contact
tracing; the adequacy of state and local health care systems; and the
effectiveness of state and local public health systems and control
measures.
Additionally, this final rule states that the Director may prohibit
the introduction of persons into the United States for such period of
time as he or she ``deems necessary to avert the serious danger of the
introduction of a quarantinable communicable disease.'' The IFR stated
that the Director may prohibit the introduction into the United States
of persons for such period of time that he or she ``deems necessary for
the public health.'' HHS/CDC makes this change so that the final rule
more closely tracks the statutory text.
Finally, in section 71.40(a)(2), HHS/CDC includes the phrase
``suspension of the right to introduce,'' instead of ``suspension of
the introduction'' of persons. The final rule language tracks the
statute verbatim. HHS/CDC interprets the statutory phrase ``suspension
of the right to introduce'' in section 71.40(b)(5). As discussed more
fully below, HHS/CDC clarifies that the ``suspension of the right to
introduce'' means to cause the temporary cessation of the effect of any
law, rule, decree, or order pursuant to which a person might otherwise
have the right to be introduced or seek introduction into the United
States.

B. Section 71.40(b)

Section 71.40(b) of this final rule defines some of the statutory
language that HHS/CDC has incorporated into section 71.40(a) of this
final rule.
1. 71.40(b)(1): ``Introduction into the United States''
As explained above, section 71.40(a) of this final rule tracks the
language of section 362 of the PHS Act, stating that the Director ``may
prohibit, in whole or in part, the introduction into the United States
of persons . . . .'' Section 71.40(b)(1) of this final rule defines
``introduction into the United States'' as the movement of a person
from a foreign country (or one or more political subdivisions or
regions thereof) or place, or series of foreign countries or places,
into the United States so as to bring the person into contact with
persons or property in the United States, in a manner that the Director
determines to present a risk of transmission of a quarantinable
communicable disease to persons, or a risk of contamination of property
with a quarantinable communicable disease, even if the quarantinable
communicable disease has already been introduced, transmitted, or is
spreading within the United States.

This definition is consistent with dictionary definitions of
``introduction,'' Congress' and courts' use of the phrase, and the
interest of public health.
The word ``introduction'' is the noun form of ``introduce,'' which
``is a flexible and broad term.'' U.S. v. Trek Leather, Inc., 767 F.3d
1288, 1298 (Fed. Cir. 2014). Dictionaries from around the eras when
both the Act of 1893 and section 362 were enacted contain similarly
broad definitions of ``introduction.'' \165\ The definitions support
HHS/CDC's view that the

[[Page 56445]]

``introduction'' of a person into the United States can include a
person's bringing of himself or herself into the United States, or a
third party's bringing of the person into the United States.
---------------------------------------------------------------------------

\165\ See Universal English Dictionary 1067 (John Craig ed.
1861) (defining ``introduction'' to include, inter alia, ``the act
of bringing into a country'' as well as ``the ushering of a person
into presence''); American Dictionary of the English Language 113
(Noah Webster ed., 1st ed. 1828) (similar definitions); Funk and
Wagnall's New Standard Dictionary of the English Language (1946)
(defining ``introduce'' as to ``bring, lead, or put in; conduct
inward; usher in; insert'' and ``introduction'' as the ``act of
introducing, in any sense, as of inserting, bringing into notice or
use, making acquainted; as, the introduction of a key into a door,
or of one person to another'').
---------------------------------------------------------------------------

Congress has used the words ``introduce'' and ``introduction''
elsewhere in Title 42 of the U.S. Code when referring to the movement
into commerce of goods that cause pollution. 42 U.S.C. 7545(c) (``The
Administrator may . . . control or prohibit the . . . introduction into
commerce . . . of any fuel or fuel additive . . .''), 7522(a)(1)
(prohibiting ``the introduction, or delivery for introduction, into
commerce,'' of certain motor vehicles). Courts have explained that
``introduction into commerce commences upon the arrival of imported
goods upon United States soil, but introduction does not necessarily
end there.'' United States v. Steinfels, 753 F.2d 373, 377 (5th Cir.
1985). Once goods are on U.S. soil and clear customs, the seller of the
goods may continually introduce them into commerce through his or her
conduct. Id. at 378. Thus, ``introduction'' may be a continuing
process, as opposed to a single event that occurs at a fixed point in
time.
The dictionaries, other statutes within Title 42, and case law are
all helpful to the interpretation of the phrase ``introduction into the
United States.'' None of those authorities, however, squarely address
how closely a person must interact with the United States and for how
long to constitute an ``introduction'' in the context of transmitting
disease. The interpretation of ``introduction'' is within CDC's
delegated statutory authority. City of Arlington, Tex. v. F.C.C., 569
U.S. 290, 296 (2013) (``Congress knows to speak . . . in capacious
terms when,'' as here, ``it wishes to enlarge[ ] agency discretion'').
It is also squarely within the expertise of HHS/CDC: It involves
scientific and technical knowledge and experience regarding
communicable diseases generally, and the application of such knowledge
and experience to the unique facts and circumstances of the specific
quarantinable communicable disease that threatens public health.\166\
---------------------------------------------------------------------------

\166\ The courts frequently defer to the CDC's judgment on such
issues. In re Approval of Judicial Emergency Declared in Eastern
District of California, 956 F.3d 1175, 1181 (9th Cir. 2020)
(determining that it would not be safe to resume normal court
operations until ``the CDC lifts its guidance regarding travel-
associated risks and congregate settings and physical distancing'');
Valentine v. Collier, 956 F.3d 797, 801 (5th Cir. 2020) (staying
preliminary injunction that required prison officials to immediately
implement measures in excess of those suggested by CDC guidelines);
Elim Romanian Pentecostal Church v. Pritzker, 962 F.3d 341 (7th Cir.
2020) (upholding against constitutional challenge an executive order
that was grounded in CDC guidelines); Hickox v. Christie, 205
F.Supp.3d 579, 598-99 (D.N.J. 2016) (relying on CDC recommendations
to determine the appropriate way to assess the risk from Ebola).
---------------------------------------------------------------------------

HHS/CDC's regulatory definition in section 71.40(b)(1) resolves the
ambiguity by making clear that the introduction of a person into the
United States can occur, for example, when a person on U.S. soil moves
further into the United States, and comes into contact with new persons
or property in ways that increase the risk of spreading the
quarantinable communicable disease. ``Introduction'' does not
necessarily conclude the instant that the person first steps onto U.S.
soil. If the person has been on U.S. soil, and HHS/CDC (through CBP)
stops the person's movement before he or she comes into contact with
new persons or property in a way that risks spreading a quarantinable
communicable disease, then HHS/CDC has prevented the introduction of
the person under section 362. For example, if a person walked from
Canada to Vermont, walked 15 miles into the United States, and was
intercepted by DHS before coming into contact with new persons or
property, and returned to Canada without entering a congregate setting,
then HHS/CDC would have prevented the ``introduction'' of the person
into the U.S.
A person who has been in the United States for longer than the
incubation period of the quarantinable communicable disease, and has
not yet exhibited symptoms or tested positive for the quarantinable
communicable disease, may have finished introducing himself or herself
into the United States. That determination, however, will be based on
HHS/CDC's application of its scientific and technical expertise to the
specific facts and circumstances.
2. 71.40(b)(2): ``Prohibit, in whole or in part, the introduction into
the United States of persons''
In section 362, Congress gave the Secretary ``the power to
prohibit, in whole or in part, the introduction [into the United
States] of persons . . . from such countries or places as he shall
designate in order to avert'' an increase in the ``serious danger of
the introduction of [any communicable disease in a foreign country]
into the United States.'' Congress' grant of authority is general in
scope. When Congress enacted section 362, the power to ``prohibit''
meant the power ``to forbid; to interdict by authority; to hinder; to
debar; to prevent; [or] to preclude.'' \167\ Congress did not specify
how the Secretary should go about debarring, preventing, or precluding
the introduction of persons ``in order to avert'' the increased danger
to public health. Nor did Congress specify how prohibitions of persons
``in whole'' differ from prohibitions of persons ``in part.''
---------------------------------------------------------------------------

\167\ Prohibit, Universal English Dictionary 458 (John Craig ed.
1869); see also Prohibit, Funk and Wagnall's New Standard Dictionary
of the English Language 1980 (1946) (``to forbid, especially by
authority or legal enactment . . .''); Prohibit, Oxford English
Dictionary 1441 (1933) (``to forbid (an action or thing) by or as by
a command or statute; to interdict'').
---------------------------------------------------------------------------

It has long been recognized that ``where a general power is
conferred or duty enjoined, every particular power necessary for the
exercise of the one, or the performance of the other, is also
conferred.'' \168\ Here, HHS/CDC identifies particular powers that it
may exercise under section 362 by defining the phrase to ``[p]rohibit,
in whole or in part, the introduction into the United States of
persons'' to mean ``to prevent the introduction of persons into the
United States by suspending any right to introduce into the United
States, physically stopping or restricting movement into the United
States, or physically expelling from the United States some or all of
the persons.'' The definition clarifies that prohibitions on
introduction could include not only CDC orders suspending rights to
introduce persons, but also actions by HHS/CDC or its Federal or state
partners to physically expel persons from, or stop or restrict the
movement of persons into, the United States. The definition further
explains that the Director may apply different prohibitions against
some or all of the persons from the foreign country who seek
introduction into the United States. The Director may, for example,
suspend all rights to introduce all persons from the foreign country,
request that DHS physically expel the cohort of persons from the
foreign country who are already on U.S. soil, and further request that
DHS stop the movement into the United States of any other persons from
the foreign country who are not on U.S. soil.
---------------------------------------------------------------------------

\168\ Luis v. United States, 136 S. Ct. 1083, 1097 (2016)
(Thomas, J., concurring) (quoting Thomas Cooley, Constitutional
Limitations 63 (1868)); see also 1 J. Kent, Commentaries on American
Law 464 (13th ed. 1884) (``whenever a power is given by a statute,
everything necessary to the making of it effectual or requisite to
attain the end is implied'').
---------------------------------------------------------------------------

These particular powers are necessary because the introduction into
the United States of persons from a foreign country may continue after
they have crossed a U.S. land border and moved onto U.S. soil. If such
persons are coming into

[[Page 56446]]

contact with others in the United States in a manner that the Director
determines to present a risk of transmission of a quarantinable
communicable disease, or a risk of contamination of property, then the
Director must have the power to stop the further movement of these
persons into the United States or else the Director's power to prohibit
the introduction of persons would be rendered meaningless.
Specifically, the Director must have the power to prevent the further
movement of such persons into the United States through quarantine,
isolation, or expulsion. As discussed previously, quarantine and
isolation may be unworkable under certain circumstances or for certain
populations. In such instances, expulsion may be the only means by
which the Director can fulfill the purpose of the statute.
To the extent section 362 is silent or ambiguous as to the
particular powers available to HHS/CDC, the resolution of that
interpretive issue is within HHS/CDC's delegated statutory rulemaking
authority. City of Arlington, Tex., 569 U.S. at 296. It is also within
the expertise of HHS/CDC. HHS/CDC has scientific and technical
knowledge and experience with public health tools for slowing the
introduction into the United States of quarantinable communicable
diseases from abroad. HHS/CDC knows what public health tools HHS/CDC
must have readily available in order to avert the increased danger to
public health presented by a communicable disease from abroad. Here,
HHS/CDC interprets section 362 as conferring the power to expel persons
from the United States because HHS/CDC cannot otherwise fulfill the
purpose of section 362.
3. 71.40(b)(3): ``Serious danger of the introduction of such
quarantinable communicable disease into the United States''
As discussed above, section 362 of the PHS Act requires that the
Director determine that the existence of a communicable disease in a
foreign country presents ``a serious danger of the introduction of such
disease into the United States'' before he or she prohibits the
introduction of persons from the foreign country into the United
States. At the time Congress enacted section 362, ``serious'' meant
``[g]rave in manner or disposition; solemn; not light or volatile,''
\169\ ``[g]rave and earnest in quality, manner, feeling or disposition;
not inclined to joke or trifle,'' or ``[o]f great or relating to a
matter of importance, or having important or dangerous possible
consequences.'' \170\ Congress, however, did not explain when the
danger of the introduction of a communicable disease becomes ``grave in
manner'' or ``of great weight and importance.'' In the public health
context, the term ``serious danger'' is ambiguous.
---------------------------------------------------------------------------

\169\ Serious, Universal English Dictionary 661 (John Craig ed.
1869).
\170\ Serious, Funk and Wagnall's New Standard Dictionary of the
English Language 2233 (1946). A contemporary dictionary defines
``serious'' as ``excessive or impressive in quality, quantity,
extent, or degree.'' Serious, Merriam-Webster Dictionary, https://www.merriam-webster.com/dictionary/serious (last visited Aug. 28,
2020).
---------------------------------------------------------------------------

The resolution of the ambiguity is within HHS's delegated statutory
rulemaking authority. City of Arlington, Tex., 569 U.S. at 296. It is
also within HHS/CDC's scientific and technical expertise. HHS/CDC is
best equipped to make judgments about the dangers presented by
quarantinable communicable diseases abroad and the measures that should
be taken to mitigate those dangers.
To resolve the ambiguity, HHS defines ``serious danger of the
introduction of such quarantinable communicable disease into the United
States'' in 71.40(b)(3) as ``the probable introduction of one or more
persons capable of transmitting the quarantinable communicable disease
into the United States, even if persons or property in the United
States are already infected or contaminated with the quarantinable
communicable disease.'' This regulatory definition clarifies that, even
if persons or property in the United States are already infected or
contaminated with a quarantinable communicable disease, the
introduction of one or more additional persons capable of disease
transmission in the same or different localities can nevertheless
present a serious danger of the introduction of the disease into the
United States. Additionally, this regulatory definition clarifies that
the danger of introduction becomes serious when one or more additional
persons capable of disease transmission would more likely than not be
introduced into the United States. To be clear, this regulatory
definition does not require the Director to make a numerical finding or
a quantitative or empirical showing of probability in order to prohibit
the introduction of persons. The Director may make a qualitative
determination, based on the known facts and circumstances, that the
introduction of one or more persons capable of transmitting the
quarantinable communicable disease is probable.
HHS/CDC's experience during the COVID-19 pandemic informs its
interpretation of the statutory language. The initial epicenters of the
disease in the United States included two large urban areas: Seattle
and New York City. At that time, the danger of the introduction of
COVID-19 into other border states from Canada and Mexico, without
regard to the outbreaks in Seattle and New York City, was manifest. The
issuance of the CDC Order prohibiting the introduction of covered
aliens into the United States was in the interest of public health
because it mitigated the serious danger of cross-border introduction of
COVID-19 in the other border states.
4. 71.40(b)(4): ``Place''
HHS/CDC defines the term ``place'' to include any location
specified by the Director, including any carrier, whatever the
carrier's flag, registry, or country of origin. This clarifies that
when HHS/CDC refers to ``place'' in this final rule, it refers not just
to territory within or outside of a country, but also to carriers, as
that term is defined in 42 CFR 71.1,\171\ regardless of the carrier's
flag, registry, or country of origin.
---------------------------------------------------------------------------

\171\ 42 CFR Sec. 71.1 defines ``carrier'' to mean ``a ship,
aircraft, train, road vehicle, or other means of transport,
including military.''
---------------------------------------------------------------------------

5. 71.40(b)(5): ``Suspension of the right to introduce''
In section 71.40(b)(5), this final rule defines ``suspension of the
right to introduce,'' a phrase used in section 362, to mean ``to cause
the temporary cessation of the effect of any law, rule, decree, or
order, pursuant to which a person might otherwise have the right to be
introduced or seek introduction into the United States.''
The regulatory definition tracks the definition of the word
``suspend'' from the late 19th century. Universal English Dictionary
815 (John Craig ed. 1869) (defining ``suspend'' in part as ``to cause
to cease for a time from operation or effect, as, to suspend the habeas
corpus act'') (emphasis in original). The definition of ``suspend'' in
the early 20th century was substantially the same. See Funk and
Wagnall's New Standard Dictionary of the English Language 2432 (1946)
(defining ``suspend'' as ``to cause to cease for a time; hold back
temporarily from operation; interrupt; intermit; stay; as, to suspend
the rules; to suspend business; suspend sentence''); Oxford English
Dictionary 255 (1933) (defining ``suspend'' as to ``cause (of a law or
the like) to be for the time no longer in force; to abrogate or make
inoperative temporarily'').
The regulatory definition is also consistent with the long-standing
use of the word ``suspend'' to describe the

[[Page 56447]]

temporary cessation of the effect of other U.S. laws. The Suspension
Clause of the Constitution, which authorizes the temporary suspension
of the privilege of the writ of habeas corpus in times of rebellion or
invasion, is a prime example. U.S. Const. art. I, sec. 9, cl. 2.
Additional examples of such suspensions are found in the U.S.
Code.\172\
---------------------------------------------------------------------------

\172\ See, e.g., 10 U.S.C. Sec. 123(a) (``In time of war, or of
national emergency . . . the President may suspend the operation of
any provision of law relating to the promotion, involuntary
retirement, or separation of commissioned officers . . . .''); 22
U.S.C. Sec. 289 (stating that congressional authorization to accept
membership in the International Refugee Organization does not
constitute action ``which will have the effect of . . . suspending .
. . any of the immigration laws or other laws of the United
States''); 22 U.S.C. Sec. 5722(a) (authorizing the President to
issue an order suspending the application of United States law to
Hong Kong ``whenever the President determines that Hong Kong is not
sufficiently autonomous''); 46 U.S.C. Sec. 3101 (``When the
President decides that the needs of foreign commerce require, the
President may suspend a provision of this part for a foreign-built
vessel registered as a vessel of the United States on conditions the
President may specify'').
---------------------------------------------------------------------------

Finally, the regulatory definition is consistent with the
legislative history of section 362, as reflected in the debates
concerning its immediate (and substantially similar) statutory
predecessor, section 7 of the Act of 1893. The debates surrounding that
provision show that members of Congress understood they were granting
the President the authority to suspend immigration. See 24 Cong. Rec.
393 (1893) (statement of Sen. Hoar) (the statute would grant the
``power to suspend immigration altogether, either temporarily or
permanently as a health device''); see also id. at 393-94 (statement of
Sen. Chandler) (recognizing that section 7 would give the President the
power to suspend immigration in his discretion, whenever there is
danger of infection); 24 Cong. Rec. 470 (Jan. 10, 1893) (statement of
Sen. Gray) (stating that the exigency posed by ``invasion of contagious
disease is sufficient . . . to justify this extraordinary power of the
entire suspension of immigration.''). It is reasonable to conclude that
Congress in 1944 had the same understanding, because it re-enacted the
same phrase and there is no legislative history to the contrary.
A ``right to introduce'' persons may conceivably arise under the
Federal laws, rules, decrees, or orders governing aviation, shipping,
trade, immigration, law enforcement, or correctional facilities, among
others. The Director is not obligated to identify each specific ``right
to introduce'' an individual person that the Director suspends when
issuing an order under section 362 and this final rule. An order under
section 362 suspends the effect of ``any law, rule, decree, or order''
under which an individual person would ``otherwise have the right to be
introduced or seek introduction into the United States.''

C. Section 71.40(c)

HHS/CDC may suspend the introduction of persons into the United
States from certain places, and for certain periods, through an
administrative order executed by the Director. In section 71.40(c),
HHS/CDC describes the required contents of such order. Any order issued
by the Director under section 71.40 shall include a statement of the
following:
(1) The foreign countries (or one or more political subdivisions or
regions thereof) or places from which the introduction of persons is
being prohibited.
(2) The period of time or circumstances under which the
introduction of any persons or class of persons into the United States
is being prohibited.
(3) The conditions under which that prohibition on introduction
will be effective in whole or in part, including any exceptions that
the Director determines are appropriate.
(4) The means by which the prohibition will be implemented.
(5) The serious danger posed by the introduction of the
quarantinable communicable disease in the foreign country or countries
(or one or more political subdivisions or regions thereof) or places
from which the introduction of persons is being prohibited.
This last requirement was not included in the IFR. However, after
considering comments, HHS/CDC decided to add it. The agency has broad
powers under section 362, and the exercise of those powers pursuant to
this final rule could have significant consequences. HHS/CDC agrees
that the Director ought to provide the public with a short and concise
factual statement on the serious danger of the introduction of the
quarantinable communicable disease that justifies the exercise of those
powers. For similar reasons, this final rule also adds that any order
issued pursuant to it shall state the means by which the prohibition on
introduction shall be implemented.
Any ``class of persons'' identified by the Director pursuant to the
second requirement would be defined based on public health criteria,
which may include the epidemiology of the quarantinable communicable
disease, as well as the geographic area and specific locations of the
persons. Implementation of any order would also take into account any
international obligations of the United States. Accordingly, the
Director may make exceptions for certain persons in an order,
including: Aliens whose travel falls within the scope of section 11 of
the United Nations Headquarters Agreement or who would otherwise be
allowed entry into the United States pursuant to United States
obligations under applicable international agreements; diplomatic
travelers; U.S. government employees; and those travelling for
humanitarian purposes.

D. Section 71.40(d)

This final rule adds a requirement in Section 71.40(d) that the
Director shall, when issuing any order under this section, and as
practicable under the circumstances, consult with all Federal
departments or agencies that would be impacted by the order. The
Director shall, as practicable, provide the Federal departments or
agencies with a copy of the order before issuing it. The purpose of
this requirement is to ensure that HHS/CDC accounts for the interests
of the other departments or agencies in the order, includes appropriate
exceptions in the order, and promotes a coordinated and transparent
Federal response to the quarantinable communicable disease. It may
sometimes be impracticable to engage in such consultation before taking
action to protect the public health. In those circumstances, the
Director shall consult with Federal departments and agencies as soon as
practicable after issuing his or her order, and may then modify the
order as appropriate.
HHS/CDC might at times rely on (1) state and local authorities who
agree to help implement orders issued pursuant to section 71.40, or (2)
other Federal agencies to implement and execute the orders issued under
this section. If the order will be implemented in whole or in part by
state and local authorities under 42 U.S.C. 243(a), the Director's
order shall explain the procedures and standards by which those state
or local authorities are expected to aid in the order's enforcement.
Similarly, if the order will be implemented in whole or in part by
designated customs officers or the United States Coast Guard under 42
U.S.C. 268(b), or another Federal department or agency, then the
Director, in coordination with the Secretary of Homeland Security or
the head of the other applicable department or agency, shall explain in
the order the procedures and standards by which any authorities,
officers, or agents are expected to aid in the enforcement of

[[Page 56448]]

the order, to the extent that they are permitted to do so under their
existing legal authorities.

E. Section 71.40(e)

Section 71.40(e)(1) provides that this final rule does not apply to
members of the armed forces of the United States and associated
personnel for whom the Secretary of Defense provides assurance to the
Director that the Secretary of Defense has taken or will take measures
such as quarantine or isolation, or other measures maintaining control
over such individuals, to prevent the risk of transmission of the
quarantinable communicable disease into the United States. HHS/CDC
includes this exception because the Secretary of Defense has the
authority and means to prevent the introduction of a quarantinable
communicable disease into the United States from his or her personnel
returning from foreign countries. Therefore, this final rule need not
apply to Department of Defense personnel.
In addition, section 71.40(e)(2) provides that this final rule does
not apply to United States government employees, contractors, or assets
on orders abroad, or their accompanying family members who are on their
orders or are members of their household if the Director receives
assurances from the relevant head of agency and determines that the
head of the agency or department has taken or will take, measures such
as quarantine or isolation to prevent the risk of transmission of a
quarantinable communicable disease into the United States.

F. Section 71.40(f)

Section 71.40(f) of the IFR provided that the IFR did not apply to
U.S. citizens or LPRs. The IFR stated that determining the appropriate
protections for U.S. citizens and LPRs would benefit from additional
consideration and public comments.\173\ HHS/CDC received comments on
the potential application of section 362 of the PHS Act to U.S.
citizens and LPRs. Given the complex and important legal and policy
questions presented by the potential application of section 362 to U.S.
citizens, U.S. nationals, and LPRs, HHS/CDC has determined that it
would be in the public interest to provide notice of, and accept
comments on, any regulatory text that HHS/CDC would propose to apply to
U.S. citizens, U.S. nationals, and LPRs. Further notice and comment
would enable HHS/CDC to provide the public with a more fulsome
explanation of the potential public health threats and policy
rationales that support the regulatory text and seek further input from
the public. For now, HHS/CDC finalizes 71.40(f) to state: ``This
section shall not apply to U.S. citizens, U.S. nationals, and lawful
permanent residents.''
---------------------------------------------------------------------------

\173\ 85 FR 16559, 16564 (Mar. 24, 2020).
---------------------------------------------------------------------------

G. Section 71.40(g)

In section 71.40(g), HHS/CDC adds a severability clause. HHS/CDC
believes this final rule complies with all applicable law, and that the
invalidation of this final rule in its entirety would ultimately harm
U.S. public health. In the event that any provision of this final rule
should be held invalid or unenforceable, either facially or as applied,
the remaining provisions shall remain valid with the maximum effect as
permitted by law.

V. Responses to Public Comments

The Department provided a 30-day comment period, which closed on
April 24, 2020. The Department received 218 public comments to the IFR,
and every comment was read and considered. HHS/CDC's responses to
public comments in this section of this final rule respond directly to
comments regarding the procedures established by the IFR and finalized
in this final rule. In the interest of public transparency, HHS/CDC
also responds to some comments about the CDC Order on covered aliens
(as opposed to the procedures established by the IFR and finalized in
this final rule). In some instances, the prior sections of this final
rule address the issues raised by commenters. Additionally, HHS/CDC
does not respond to comments that are directed at other departments or
agencies or that are otherwise beyond the scope of this final rule.
Commenters included professional organizations, industry
representatives, religious organizations, and the general public. After
considering the comments, the Department finalizes the IFR with the
changes described in Section III.

General Comments

Comment: Some commenters stated 30 days was not sufficient time to
comment on the proposed rule and asked the Department to extend the
comment period.
Response: HHS/CDC respectfully disagrees that the 30-day comment
period was insufficient. HHS/CDC notes that the Administrative
Procedure Act (APA) does not have a minimum time period for comments.
Further, E.O. 13563 recommends a 60-day comment period, when feasible.
Considering the current public health emergency, HHS/CDC determined
that a 30-day comment period was sufficient for this rulemaking. The
comment period closed 30 days after publication of the IFR in the
Federal Register on March 24, 2020.
Comment: Other commenters stated that the rule should have been
issued pursuant to the agency rulemaking process governed by section
553(b) of the APA, 5 U.S.C. 553. These commenters noted that although
the agency's justification for applying the ``good cause'' emergency
exception in section 553(b)(3)(B) is understandable in the context of
the COVID-19 pandemic, the rule is intended to last beyond the current
public health crisis, so the ``good cause'' exception should not apply.
Response: HHS/CDC respectfully disagrees. Section 553(b)(3)(B) of
the APA authorizes a department or agency to dispense with the prior
notice and opportunity for public comment requirement when the agency,
for ``good cause,'' finds that notice and public comment are
``impracticable, unnecessary, or contrary to the public interest.''
Allowing for prior notice and opportunity for public comment on the
interim final rule was impracticable and contrary to the public
interest because it would have prevented HHS from establishing
procedures to allow it to quickly address the COVID-19 pandemic through
the issuance of orders such as the one suspending the introduction of
covered aliens into the United States. COVID-19 has spread rapidly, and
taking prompt measures to slow the spread of the disease was necessary
to protect public health.
Comment: Commenters stated that the IFR grants new public health
powers to the Executive Branch that did not already exist, or shifts
political accountability for the exercise of public health powers from
the President (who is elected) to the CDC Director (who is a principal
officer appointed by the President and confirmed by the U.S. Senate).
Response: Since 1944, section 362 of the PHS Act has provided that
whenever the Surgeon General (now the CDC Director, by delegation from
the HHS Secretary) determines that by reason of the existence of any
communicable disease in a foreign country there is serious danger of
the introduction of such disease into the United States, and that this
danger is so increased by the introduction of persons or property from
such country that a suspension of the right to introduce such persons
and property is required in the interest of the public health, the
Surgeon General (now the CDC Director), in accordance with regulations
approved by the President,

[[Page 56449]]

shall have the power to prohibit, in whole or in part, the introduction
of persons and property from such countries or places as he shall
designate in order to avert such danger, and for such period of time as
he may deem necessary for such purpose. A predecessor statute dating
back to 1893 granted the President similar authority. The IFR and this
final rule implement the long-standing statutory authority of the
Executive Branch, consistent with the design of Congress in 1944.
Comment: A number of commenters provided comments about the CDC
Order on covered aliens, not the IFR or this final rule. These included
comments about the particular facts underlying the CDC Order,
particular language used in the Order, such as the meaning of ``covered
aliens,'' and the public health analysis in the CDC Order. Other
commenters seemed to misunderstand the differences between the CDC
Order and the IFR and this final rule, or disagreed with the Director's
determination to apply the CDC Order only to CBP facilities at land
borders.
Response: We believe these comments confuse the IFR, the final
rule, and the CDC Order on covered aliens. The CDC Order relates
exclusively to the COVID-19 pandemic, defines ``covered aliens,'' and
prohibits the introduction of ``covered aliens'' into the United States
through congregate settings in CBP facilities at land borders. This
final rule does not define ``covered aliens.'' Nor does this final rule
prohibit the introduction of any persons into the United States without
an administrative order issued by the Director. Rather, this final rule
finalizes the procedures for the Director to use when he or she
determines that a temporary prohibition on the introduction of persons
from a foreign country into the United States is necessary in the
interest of U.S. public health. The procedures in this final rule are
general in nature; they are not limited to a specific quarantinable
communicable disease or person or category of persons.
Comment: A number of commenters stated that the period of
preventing introduction of COVID-19 to U.S. populations has now passed
and that our highest priority as a nation must be to reduce community
spread through the current tools we have available such as self-
isolation.
Response: HHS/CDC disagrees with the proposition that HHS/CDC
should limit its response to the COVID-19 pandemic to the use of
conditional release orders or recommendations to self-quarantine or
self-isolate or similar public health tools. HHS/CDC and its state and
local partners are using public health tools such as quarantine,
isolation, and conditional release to mitigate the spread of COVID-19.
But the use of those public health tools does not and should not
foreclose the appropriate use of other public health tools--including
the statutory authority to prohibit the introduction of persons--to
combat the disease. HHS/CDC needs the flexibility to deploy the full
array of available public health tools in response to the COVID-19
pandemic, which continues to evolve within the United States and
abroad.
Even now, the introduction into the United States of persons from
foreign countries with COVID-19 would increase the serious danger of
further introduction of COVID-19 into different areas of the United
States. The section 362 authority and this final rule remain critical
to mitigating the further introduction of COVID-19 into those areas.
Moreover, this final rule seeks to implement a permanent procedure
which the Director may use to issue an order suspending the right to
introduce persons into the United States when there is a serious danger
of the introduction of a quarantinable communicable disease into the
United States. This final rule is needed to address not only the COVID-
19 pandemic, but also future public health threats.
Comments: A commenter stated that the IFR is arbitrary and
capricious because the agency has failed to consider important factors,
such as the impact that the CDC Order on covered aliens will have on
individuals who seek to enter the United States and on those in the
United States who are awaiting their arrival; reliance interests; and
alternatives to suspending migration, such as quarantine or isolation
of persons.
Response: This final rule explains why the benefits to U.S. public
health that flow from mitigating the introduction of quarantinable
communicable diseases into the United States may outweigh any impact on
family well-being that may result from deferred visitation of family
members in the United States. The same reasoning applies to non-family
members who await the arrival of persons in the U.S. This final rule
also discusses reasonable alternatives that were considered, and why
prohibitions on the introduction of persons may sometimes be more
appropriate public health measures than quarantine and isolation.
Comment: Some commenters stated that the final rule would have a
negative effect on the economy because immigrants from Mexico or Canada
would be unable to come to the United States to participate in the
labor market.
Response: This final rule provides that when issuing any Order, the
Director shall, as practicable under the circumstances, consult with
all Federal departments or agencies whose interests would be impacted
by the Order, which may include the U.S. Departments of Agriculture,
Commerce, and the Treasury. Any potential economic consequences of an
Order would be considered by the Director as part of the consultation
process.
Comment: A number of commenters opined that expulsions of aliens to
Central America and Mexico may exacerbate public health challenges
during the COVID-19 pandemic.
Response: These comments appear to be directed at the CDC Order on
covered aliens issued pursuant to the IFR, and not this final rule.
This final rule provides a mechanism for the CDC Director to prohibit
the introduction of persons when he or she determines that by reason of
the existence of any communicable disease in a foreign country, there
is serious danger of the introduction of such disease into the United
States, and that this danger is so increased by the introduction of
persons from such country that a suspension of the right to introduce
such persons is required in the interest of public health. If the CDC
Director determines, in the exercise of his or her scientific and
technical expertise, that these conditions are met and expulsion is in
the interest of the public health, he or she may issue an
administrative order pursuant to this final rule that requires
expulsion. This final rule, standing alone, does not require expulsion.
Comments: Some commenters stated that there could be particular
vulnerability or hardship to ``LGBTIQ'' persons, women, or children.
Response: HHS/CDC works to protect the United States from health,
safety and security threats, both foreign and in the United States.
Whether diseases start at home or abroad, are chronic or acute, curable
or preventable, human error or deliberate attack, HHS/CDC fights
disease and supports communities and citizens to do the same. HHS/CDC
believes this final rule will help HHS/CDC accomplish its mission.
Under this final rule, the Director would consult with other Federal
departments and agencies whose interests would be impacted by any
Order, including the U.S. Department of Homeland Security, and would
have the discretion to include exceptions for persons in the Order when
appropriate.

[[Page 56450]]

Comments: A number of commenters stated that expelling an alien
under section 362 of the PHS Act violates the United States'
obligations under the 1967 Protocol relating to the Status of Refugees
(1967 Refugee Protocol) and the Convention against Torture and Other
Cruel, Inhuman or Degrading Treatment or Punishment (CAT) and violates
statutory protections, including the William Wilberforce Trafficking
Victims Protection Reauthorization Act of 2008 (TVPRA), the CAT
regulations implemented pursuant to the Foreign Affairs Reform and
Restructuring Act of 1998 (FARRA) (8 U.S.C. 1231 note), the asylum and
withholding provisions at 8 U.S.C. 1158 and 1231(b)(3), and the
American Declaration on the Rights and Duties of Man. Some commenters
said the IFR fails to provide legal process to individuals subject to
the rule, including asylum-seekers, even though U.S. law guarantees
aliens an opportunity to request protection at POEs after crossing into
the United States. Commenters also stated that expelling an alien who
is a minor violates the Stipulated Settlement Agreement in Flores v.
Barr, 934 F.3d 910 (C.D.Cal. 2019) (the ``Flores Settlement
Agreement,'' or the ``FSA'').
Responses: These comments are directed to the CDC Order on covered
aliens issued pursuant to the IFR, and not this final rule. To the
extent these comments are directed to both the CDC Order and this final
rule, HHS/CDC respectfully disagrees with them. In section 362 of the
PHS Act, Congress authorized the suspension of the introduction of
persons into the United States when a suspension of the right to
introduce persons is required in the interest of U.S. public health.
Congress did not exempt from the scope of section 362 any category of
persons or any rights of introduction under specific laws, including
any found in Title 8 of the U.S. Code.

The TVPRA and the FSA

The requirements of the TVPRA and FSA do not generally apply to
situations where the Director has determined that a suspension of the
right to introduce persons is required in the interest of public
health. The Flores settlement agreement and the statutory provisions
providing that unaccompanied alien children (UACs) \174\ are to be
transferred to the care and custody of HHS's Office of Refugee
Resettlement (ORR) are directed towards the continuing custody and the
conditions of confinement in which minors are held in custody within
the United States. See, e.g., 6 U.S.C. 279 (defining ``UAC'' in
subsection 279(g) and referring to ``the care of unaccompanied alien
children'' in subsection 279(a)); Flores Settlement Agreement at 7
(defining the relevant class as ``[a]ll minors who are detained in the
legal custody of the INS'').
---------------------------------------------------------------------------

\174\ ``[T]he term `unaccompanied alien child' [UAC] means a
child who--(A) has no lawful immigration status in the United
States; (B) has not attained 18 years of age; and (C) with respect
to whom--(i) there is no parent or legal guardian in the United
States; or (ii) no parent or legal guardian in the United States is
available to provide care and custody.'' 6 U.S.C. 279(g). The
Director of the Office of Refugee Resettlement (ORR) of HHS is
responsible, among other things, for ``coordinating and implementing
the care and placement of [UAC] who are in Federal custody by reason
of their immigration status.'' 6 U.S.C. Sec. 279(b)(1)(A).
---------------------------------------------------------------------------

The TVPRA provides specific processes governing the custody and
removal of UACs under Title 8. But the CDC has prohibited the
introduction of aliens under section 362 of the PHS Act for public
health reasons without regard to the age of the alien (or the persons
accompanying him), and actions to enforce the CDC prohibition
necessarily involve the prohibition on entering or return of an alien
outside of Title 8's procedures.
Therefore, suspension of introduction, and the derivative expulsion
authority under section 362 of the PHS Act generally operates
independently from Title 8 with respect to minors and other persons.
The custody requirement under 8 U.S.C. 1232(b)(3) within the TVPRA is
not a rule governing the procedures by which an alien is removed or
expelled. Rather, it is a statutory obligation that applies to all
departments and agencies in the U.S. government, whether or not the
government is removing UACs pursuant to Title 8 (or expelling minors
under Title 42). This subsection requires only that UACs in the custody
of a Federal department or agency be transferred to the custody of HHS
within 72 hours unless ``exceptional circumstances'' apply. 8 U.S.C.
1232(b)(3). The current public health emergency plainly would qualify
as an ``exceptional circumstance[ ]'' permitting an exception from the
72-hour transfer requirement.
The FSA governs the conditions under which minors may be held in
government custody in connection with their arrest or detention under
immigration laws. FSA ] 10 (defining the class as ``All minors who are
detained in the legal custody of the INS.''), ] 12, ] 14 (``Where the
INS determines that the detention of the minor is not required either
to secure his or her timely appearance before the INS or the
immigration court, or to ensure the minor's safety or that of others,
the INS shall release a minor from its custody without unnecessary
delay . . . .''). Minors who are subject to a prohibition on
introduction under section 362 of the PHS Act would not be arrested or
detained under the immigration laws and they are expelled from the
United States as expeditiously as possible. Minors who comply with a
public health order under section 362 would not be arrested for
violating the PHS Act or the order either. The FSA therefore does not
apply to minors who are quarantined, isolated, or expelled under a
public health order.
Indeed, ``the [FSA] is a binding contract and a consent decree. . .
. It is a creature of the parties' own contractual agreements and is
analyzed as a contract for purposes of enforcement.'' Flores v. Barr,
407 F. Supp. 3d 909, 931 (C.D. Cal. 2019); see also City of Las Vegas
v. Clark Cty., 755 F.2d 697, 702 (9th Cir. 1985) (``A consent decree,
which has attributes of a contract and a judicial act, is construed
with reference to ordinary contract principles.''). The FSA applies
only to those minors in the ``legal custody'' of the former Immigration
and Naturalization Service (INS) as the term was intended by the
parties when the Agreement was signed in 1997. FSA ]] 4, 10. That means
it applies to minors who are in immigration custody under Title 8. The
Agreement does not encompass, was not intended to encompass, and did
not anticipate custody incident to a public health order issued
pursuant to the PHS Act. If a minor were expelled under section 362,
that minor would not be in the ``legal custody'' of any legal successor
to any party to the FSA. Although the FSA does not explicitly define
``legal custody,'' it recognizes a critical distinction between legal
custody and physical custody. The FSA provides for the INS in some
instances to place a minor in the physical custody of a licensed
program, but the FSA specifies that the minor remains in the legal
custody of the INS. FSA ] 19; see also Gao v. Jenifer, 185 F.3d 548,
551 (6th Cir. 1999) (explaining that the INS's contracts with these
third-party programs explicitly state that the INS retains legal
custody while the programs have physical custody). While a minor is in
the physical custody of a licensed program, the INS retains the sole
authority to transfer and release the minor (except that the licensed
program can transfer physical custody in emergencies). FSA ] 19. Thus,
paragraph 19 makes clear that under the Agreement, the ``legal custody
of the INS'' means custody at the direction of the INS under relevant
immigration

[[Page 56451]]

laws, which grant the INS authority over the detention or release of
the minor. Id.
The original class certified in the Flores litigation included only
individuals under the age of eighteen who ``are, or will be arrested
and detained pursuant to 8 U.S.C. 1252.'' In 1986, when the class was
certified, 8 U.S.C. 1252 governed discretionary detention during
deportation proceedings. At the time the FSA was signed in 1997, the
INS's legal authority to detain minors remained within Title 8 of the
U.S. Code. 8 U.S.C. 1225(b), 1252(a); see also Reno v. Flores, 507 U.S.
292, 294-95 n.1 (1993). Such detention was incident to immigration
removal proceedings, the authority for which was also detailed in Title
8. 8 U.S.C. 1225(a), 1226, 1231, 1252(b). The authority for immigration
proceedings, as well as the authority to hold minors in immigration
custody, is still found in Title 8 today. See 8 U.S.C. 1225, 1226,
1231, and 1232. The successors of the INS who carry out these
immigration functions today are CBP, ICE, and U.S. Citizenship and
Immigration Services, all of which are part of DHS, as well as the ORR
in HHS with respect to UACs. See Homeland Security Act of 2002, 402,
462, 1512, Public Law 107-296, 116 Stat. 2135 (November 25, 2002)
(codified at 6 U.S.C. 202, 279, 552); TVPRA, 8 U.S.C. 1232.
CDC, though part of HHS along with ORR, is not a successor to the
INS with respect to the detention addressed in the FSA. Custody
incident to the government's implementation of order issued by the
Director under its section 362 authority is different from the Title 8
immigration custody that the Agreement covers.\175\ Section 362
provides the Director with ``the power to prohibit, in whole or in
part, the introduction of persons and property from such countries or
places as he shall designate in order to avert such danger, and for
such period of time as he may deem necessary for such purpose.''
Custody incident to implementation of this provision is not pursuant to
immigration laws. The Director, not DHS, has the legal authority for
these processes.\176\ Individuals processed under Title 42 are not
processed for immigration enforcement actions.
---------------------------------------------------------------------------

\175\ See, e.g., Order Suspending Introduction of Certain
Persons from Countries Where a Communicable Disease Exists, 85 FR
17060 (Mar. 26, 2020).
\176\ The INS could not have implemented CDC's section 362
orders. The role of DHS in public health enforcement is pursuant to
section 365 of the PHS Act, which provides, ``It shall be the duty
of the customs officers and of Coast Guard officers to aid in the
enforcement of quarantine rules and regulations . . . .'' Neither
the Coast Guard, nor any customs officers, were part of the INS. The
customs officer authorities now within DHS were transferred from the
Department of the Treasury to DHS with the Homeland Security Act. 6
U.S.C. Sec. 203. DHS's role in enforcing the HHS/CDC Order arises
from the PHS Act, not any immigration statute. The Agreement did not
cover the Treasury Department.
---------------------------------------------------------------------------

At the time the FSA was signed in 1997, the parties could not have
anticipated the COVID-19 pandemic in 2020, and that some of the legal-
successor agencies to the INS would be charged with implementing
emergency procedures on behalf of the Director under section 362. The
``basic goal of contract interpretation'' is to give effect to the
parties' mutual intent ``at the time of contracting.'' Founding Members
of the Newport Beach Country Club v. Newport Beach Country Club, Inc.,
109 Cal. App. 4th 944, 955 (Cal. Ct. App. 2003) (citing Cal. Civ. Code
Sec. 1636). The sections of Title 42 being implemented in this final
rule are not immigration statutes or even custody statutes, and their
purview is not limited to aliens. Rather, they provide broad authority
to CDC to respond to public health threats. Further, the FSA makes
clear that the parties were addressing and settling specific issues
related to custody by the INS incident to immigration proceedings,
under the applicable law governing that custody. See, e.g., FSA ]] 9,
11, 12.A, 14, 24.A (providing for bond hearings before an immigration
judge). Nothing in the FSA suggests that the parties intended it to
govern--or anticipated that it would govern--any emergency procedures
implemented by the HHS/CDC under section 362 of the PHS Act.

The CAT and the 1967 Refugee Protocol

The final rule implements authority under section 362 of the PHS
Act, which authorizes a prohibition on the introduction of persons in
the interest of public health. Although HHS/CDC believes that the final
rule is entirely consistent with the international obligations of the
United States under the CAT and the 1967 Refugee Protocol, those
international treaties are non-self-executing. See Khan v. Holder, 584
F.3d 773, 783 (9th Cir. 2009) (``[T]he [Refugee] Protocol is not self-
executing.''); Auguste v. Ridge, 395 F.3d 123, 132 (3d Cir. 2005) (the
CAT ``was not self-executing''); Trinidad y Garcia v. Thomas, 683 F.3d
952, 955 (9th Cir. 2012) (en banc) (per curiam) (``The CAT is a treaty
signed and ratified by the United States, but is non-self-executing.
136 Cong. Rec. 36, 198 (1990).''). Therefore, the domestic statutes
that implement these obligations and their corresponding regulations
would control as a matter of domestic law in the event of any potential
conflict. See Medellin v. Texas, 552 U.S. 491, 504 n.2 (2008) (``A
`non-self-executing' treaty does not by itself give rise to
domestically enforceable federal law. Whether such a treaty has
domestic effect depends upon implementing legislation passed by
Congress.'').
Congress implemented certain aspects of CAT into domestic law by
statute as part of the Foreign Affairs Reform and Restructuring Act of
1998 (FARRA). 8 U.S.C. 1231 note. That statute declares it to be ``the
policy of the United States not to expel, extradite, or otherwise
effect the involuntary return of any person to a country in which there
are substantial grounds for believing the person would be in danger of
being subjected to torture'' and to prescribe regulations to implement
U.S. obligations under Article 3 of the Conventions. See Public Law
105-277, div. G, subdiv. B, title XXII, Sec. 2242(a)-(b) (1998),
codified at 8 U.S.C. 1231 note. In its ratification statement
accompanying the treaty, the U.S. Senate observed that the
``substantial grounds'' requirement would be interpreted as requiring
an alien to establish that it would be ``more likely than not that he
would be tortured'' in the prospective country of removal. Resolution
of Ratification, Convention Against Torture and Other Cruel, Inhuman or
Degrading Treatment or Punishment, Senate Consideration of Treaty
Document 100-20, II.(2), 136 Cong. Rec. S17904 (Oct. 27, 1990).
Under 42 U.S.C. 268, customs officers have an obligation to aid in
enforcement of HHS/CDC's administrative Orders issued under section 362
of the PHS Act. HHS/CDC therefore expects that DHS will take the lead
role in enforcing any CDC Order prohibiting the introduction of persons
into the United States. In connection with existing enforcement of the
current CDC Order on covered aliens, HHS/CDC understands that DHS
provides aliens with the opportunity to express a fear that they will
suffer torture in the country to which they are being returned. So long
as border officials apply a process for assessing non-refoulement
concerns, as appropriate, the government satisfies its treaty
obligations, as reflected in the FARRA. See Trinidad y Garcia, 683 F.3d
at 956-57 (concluding, in a challenge to extradition on non-refoulement
grounds, that if the agency found it ``more likely than not'' that an
extradited person would not face torture abroad, then ``the court's
inquiry shall have reached its end'').
In addition to implementing its CAT obligations through the FARRA,
the

[[Page 56452]]

United States has implemented the non-refoulement obligation under the
1967 Protocol by enacting the withholding-of-removal provisions in
section 241(b)(3) of the INA (8 U.S.C. 1231(b)(3)). These statutory
provisions prohibit the removal of an individual to a country where he
or she would face persecution or torture, subject to several statutory
exceptions. One such exception excludes any alien from statutory
withholding-of-removal protection where ``there are reasonable grounds
to believe that the alien is a danger to the security of the United
States.'' Id. 1231(b)(3)(B)(iv). This statutory exception is derived
from Article 33 of the 1967 Protocol, which contains an exception for a
refugee for ``whom there are reasonable grounds for regarding as a
danger to the security of the country in which he is.'' See 1967
Protocol, Article 33.2.
In Matter of A-H-, 23 I&N Dec. 774 (2005), the Attorney General
interpreted the phrase ``danger to the security of the United States''
in an analogous provision of the INA (the former section 243(h)(2)(D)
of the INA) to mean ``a risk to the Nation's defense, foreign
relations, or economic interests.'' In re Matter of A-H-, 23 I&N Dec.
774, 788 (AG 2005); see also Yusupov v. Attorney General of U.S., 518
F.3d 185, 204 (3d Cir. 2008) (upholding in relevant part the Attorney
General's interpretation in Matter of A-H-); cf. 8 U.S.C. 1189(d)(2)
(defining ``national security'' in a separate provision of the INA as
encompassing ``the national defense, foreign relations, or economic
interests of the United States''). Because enforcement of a CDC Order
would occur pursuant to section 362 of the PHS Act, this provision of
the INA does not directly apply to orders issued under the final rule.
Nonetheless, where the Director has determined that there is a
reasonable ground to believe that the introduction of an alien, or
class of aliens, would pose a danger of introducing a quarantinable
communicable disease into the United States, then there would be a
reasonable ground for regarding those aliens to be as ``a danger to the
security of the United States'' as construed by Matter of A-H. See
Notice of Proposed Rulemaking, Security Bars and Processing, 85 FR
41,201, 41,208-41,210 (July 9, 2020). As the ongoing COVID-19 pandemic
has shown, the entry and spread of communicable disease from abroad can
threaten the lives of the U.S. population and inflict grievous harm on
the national economy.
In addition, this final rule would allow for the Director to
address any additional humanitarian concerns, if appropriate, in
connection with implementing the Order. As explained in this final
rule, the Director may provide that certain persons are excepted in an
Order, and that could include exceptions for persons traveling for
humanitarian purposes. The Director expects to consult with relevant
federal departments and agencies when issuing any order under section
71.40(d). For the same reasons, the American Declaration on the Rights
and Duties of Man does not bar this final rule.
Comments: One commenter stated that the IFR applies only to land
borders, even though, as the IFR itself notes, transportation hubs,
like airports and cruise ship terminals, are congregate settings
``conducive to disease transmission.'' The IFR does not bar travel by
tourists arriving by plane or ship, even though these modes of
transportation are explicitly listed as congregate settings with a risk
of disease transmission.
Response: These comments appear to be directed to the CDC Order on
covered aliens issued pursuant to the IFR, and not the IFR or this
final rule. The CDC Director may use the procedures in the IFR and this
final rule to issue an administrative order that applies to persons who
seek to introduce themselves into the United States through airports or
cruise ship terminals. There are, however, additional tools available
to address public health risks in transportation hubs. Such tools
include proclamations under section 212(f) of the INA and No Sail
Orders.

Section 71.40(a), Statutory Requirements for the CDC Director To
Suspend the Introduction of Persons Into the United States

Comments: Several commenters stated that, taken together, the IFR
and CDC Order on covered aliens incorrectly assume that persons from a
foreign country cannot self-quarantine or self-isolate in the United
States as an alternative to expulsion. These commenters noted that many
persons trying to cross the U.S.-Mexico border know people in the
United States who could presumably provide a place to self-quarantine
or self-isolate. Some commenters also suggested that DHS could parole
asylum-seekers into the United States to await their asylum proceedings
in U.S. immigration courts.
Response: To the extent the commenters maintain that HHS/CDC can
never lawfully prohibit the introduction of persons into the United
States through the expulsion of persons, HHS/CDC respectfully disagrees
with the comments. As previously discussed, the specific power to expel
persons is a corollary to the general power to prohibit the
introduction of persons. HHS/CDC cannot effectuate the authority
granted by section 362 unless HHS/CDC can expel persons, particularly
in cases where quarantine and isolation are inadequate due to
epidemiological factors, resource limitations, geography, location, or
other considerations.
In the case of the CDC Order issued pursuant to the IFR, it is not
reasonable to assume that all covered aliens subject to the Order can
or will comply with conditional release orders or safely self-
quarantine or self-isolate after introduction into the country. That
has not been HHS/CDC's experience with foreign nationals arriving in
the United States on commercial flights, which require valid travel
documents and clearance of customs. Even some foreign nationals who
produce valid travel documents, fly internationally, and clear customs
do not comply with self-quarantine or self-isolation protocols, or
provide contact information to HHS/CDC for use in public health
monitoring and contract tracing investigations.
Covered aliens under the CDC Order seek to introduce themselves
into the United States under circumstances and in ways that suggest to
HHS/CDC that they are less likely to adhere to a conditional release
order or self-quarantine or self-isolation protocol. For starters, all
covered aliens lack valid travel documents, which suggests that they
are not coming prepared to comply with U.S. legal processes. Many walk
into the United States from Mexico or Canada, which suggests that they
do not have access to transportation. DHS informs HHS/CDC that under
normal circumstances--when the introduction of persons is not
suspended--many covered aliens would be asylum-seekers, who by
definition lack permanent U.S. residences. DHS and DOJ also inform HHS/
CDC that under normal circumstances, many would be removed from the
United States in absentia for failure to appear for immigration
proceedings.\177\ Persons who are unprepared to comply with U.S. legal
processes and lack transportation and a permanent U.S. residence would
likely encounter difficulties complying with conditional release orders
or self-quarantine or self-isolation protocols. For such orders or

[[Page 56453]]

protocols to be effective, persons who HHS/CDC temporarily apprehends
and then conditionally releases with orders--or, alternatively, persons
to whom HHS/CDC recommends self-quarantine or self-isolation--must be
able to travel to suitable quarantine or isolation locations, and then
quarantine or isolate for the time period prescribed or recommended by
HHS/CDC. Many covered aliens subject to the CDC Order on covered aliens
would have to overcome significant hurdles to meet those basic
requirements.
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\177\ In fiscal year 2019, out of 181,876 initial case
completions for aliens who are not UACs, 82,753 aliens (45%) were
ordered removed in absentia. In the first two quarters of fiscal
year 2020, out of 154,744 initial case completions for aliens who
are not UACs, 81,330 aliens (53%) were ordered removed in absentia.
---------------------------------------------------------------------------

Moreover, implementation of conditional release orders for covered
aliens would divert substantial HHS/CDC resources away from existing
public health operations during the COVID-19 pandemic. HHS/CDC
presently operates quarantine stations at 20 ports of entry and land-
border crossings, only four of which are at a border with Canada or
Mexico.\178\ To implement conditional release orders for covered
aliens, HHS/CDC would have to open and operate new quarantine stations
at numerous Border Patrol stations and POEs, surge technical support to
CBP at the same locations, or do some combination of both. HHS/CDC
would also have to monitor the health of tens of thousands of covered
aliens introduced into the United States, and alert public health
departments about any health issues that need follow-up.\179\ HHS/CDC
does not have resources and personnel available to execute those
additional functions; HHS/CDC would have to reallocate personnel from
existing quarantine operations, which would jeopardize the
effectiveness of those operations, endanger public health, and impose
additional costs on U.S. taxpayers.
---------------------------------------------------------------------------

\178\ Quarantine and Isolation: U.S. Quarantine Stations, Ctrs.
for Disease Control & Prevention, https://www.cdc.gov/quarantine/quarantine-stations-us.html (last updated July 24, 2020) (Those
quarantine stations are in Detroit, MI; El Paso, TX; San Diego, CA;
and Seattle, WA).
\179\ Id.
---------------------------------------------------------------------------

Several commenters asserted that HHS/CDC should nevertheless allow
covered aliens to self-quarantine or self-isolate because the U.S.
Immigration Policy Center (USIPC) interviewed 607 asylum seekers in
2019, and 91.9% of them reported having family or close friends living
in the United States. Tom K. Wong, Seeking Asylum: Part 2 (Oct. 29,
2019). USIPC, however, is not a public health agency,\180\ and its
study predated the COVID-19 pandemic. The study focused on the
condition of aliens subject to ``the Migrant Protection Protocols
(MPP), also known as the `Remain in Mexico' policy.'' Id. at 3. USIPC
did not look at whether the family or close friends had personal
residences and, if so, whether they would make them available as self-
quarantine or self-isolation locations. Nor did USIPC look at whether
residences were suitable for self-quarantine or self-isolation in
compliance with HHS/CDC guidelines.\181\
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\180\ USIPC is a part of the University of California San Diego
(UC San Diego) that ``brings together leading academics, policy
analysts, immigrant-rights leaders, and policymakers across all
levels of government to conceptualize, debate, and design a new U.S.
immigration policy agenda . . . .'' U.S. Immigration Policy Ctr., UC
San Diego, https://usipc.ucsd.edu/ (last visited Sep.1, 2020). The
USIPC website encourages readers to ``[v]isit UC San Diego's
Coronavirus portal for the latest information on the campus
community.'' Id. On the portal, UC San Diego informs students,
faculty, and staff that for Fall 2020, in-person class size ``is
limited to fewer than 50 students per class, or 25% of classroom
capacity, whichever is smaller.'' Return to Learn: Fall 2020 Plan,
UC San Diego, https://returntolearn.ucsd.edu/return-to-campus/fall-2020-lan/index.html (last visited Sep. 1, 2020). UC San Diego
further states that ``[i]f a student is coming to campus from an
international location, CDC guidelines recommend a 14-day quarantine
period. Students with a housing contract can complete the quarantine
period in specially designated on-campus housing . . . .'' Id.
(emphasis added). The USIPC website suggests that USIPC defers to UC
San Diego on public health issues, and that UC San Diego generally
follows CDC guidance when addressing such issues.
\181\ Persons who self-isolate should stay home except to get
medical care. When at home, they should stay in a separate room from
other household members, if possible; use a separate bathroom, if
possible; avoid contact with other members of the household and
pets; and avoid sharing personal household items, like cups, towels
and utensils. Coronavirus Disease 2019 (COVID-19), What to Do If You
Are Sick, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/steps-when-sick.html (last updated May 8, 2020). Persons who self-quarantine
should stay at home for 14 days after their last contact with a
person who has COVID-19, watch for symptoms of COVID-19, and, if
possible, stay away from others, especially people who are at higher
risk for getting very sick from COVID-19. Coronavirus Disease 2019
(COVID-19), When to Quarantine, Ctrs. for Disease Control &
Prevention, https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html (last updated Aug. 16, 2020). When at home,
persons in self-quarantine should stay at least 6 feet from other
people, and clean and disinfect frequently touched objects and
surfaces, among other things. Coronavirus Disease 2019 (COVID-19),
Household Checklist, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/checklist-household-ready.html (last updated June 13, 2020).
---------------------------------------------------------------------------

Even if HHS/CDC were to assume that many covered aliens have family
or close friends in the United States, that fact alone would not
control HHS/CDC's public health analysis. HHS/CDC has weighed many
considerations--including the epidemiology of COVID-19, the structural
and operational limitations of CBP facilities, the available HHS/CDC
and CBP resources, the requirements of other public health operations
during the COVID-19 pandemic, and the needs of the domestic
population--when issuing and continuing its Order on covered aliens
pursuant to the IFR. HHS/CDC maintains that its implementation of a
self-quarantine or self-isolation protocol for covered aliens would
consume undue HHS/CDC and CBP resources without averting the serious
danger of the introduction of COVID-19 into CBP facilities. Expulsion
is a more effective public health measure for CBP facilities that
preserves finite HHS/CDC resources for other public health operations.

Section 71.40(b), Definitions Used in This Section

Comment: Some commenters stated that section 362 of the PHS Act
authorizes the Secretary to stop the risk of introduction of a disease
into the United States, and the IFR unlawfully extends the Secretary's
authority to situations where a disease is already in the United
States.
Response: HHS/CDC respectfully disagrees for the reasons stated in
Section IV.B of this final rule.
Comment: Some commenters stated that HHS/CDC's inclusion of
aircraft in its definition of ``place'' exceeds the CDC's limited
statutory authority and would allow the Director to suspend the
introduction of persons, not because of the serious danger of the
introduction of a quarantinable communicable disease from a foreign
country into the United States, but because of the existence of a
quarantinable communicable disease onboard an aircraft.
Response: HHS/CDC respectfully disagrees with this comment. To
prevent the introduction of a quarantinable communicable disease, the
Director must have the authority to prohibit the introduction of
persons from a foreign country or place, as well as any carriers
carrying those persons.
Comment: A number of commenters expressed the view that the IFR
fails to give meaning to the phrase ``serious danger'' from section 362
of the PHS Act, as the IFR defines ``serious danger of the introduction
of such communicable disease into the United States'' to mean ``the
potential for introduction of vectors of the communicable disease into
the United States.''
Response: The final rule defines ``serious danger of the
introduction of such quarantinable communicable disease into the United
States'' to mean the probable introduction of one or more persons
capable of transmitting the quarantinable communicable disease into the
United States, even if persons or property in the United States

[[Page 56454]]

are already infected or contaminated with the quarantinable
communicable disease. This regulatory definition clarifies that, even
if persons or property in the United States are already infected or
contaminated with a quarantinable communicable disease, the
introduction of one or more additional persons capable of disease
transmission in the same or different localities can nevertheless
present a serious danger of the introduction of the disease into the
United States. Additionally, this regulatory definition clarifies that
the danger of introduction becomes serious when one or more additional
persons capable of disease transmission would more likely than not be
introduced into the United States. Section IV.B.3 further explains why
this definition comports with the statute.

Section 71.40(c), Director's Terms of the Suspension

Comment: A number of commenters recommended that the CDC self-
impose a required expiration for each order, or alternatively a short-
interval and recurrent review of the Director's determinations and
orders under the IFR, with such objective review conducted by an agency
inspector general or Federal third-party agency.
Response: HHS/CDC agrees that recurrent HHS/CDC review of CDC
Orders is good policy. The CDC Order on covered aliens issued and
continued pursuant to the IFR have undergone recurrent review. Section
71.40(c) of this final rule provides that any order issued pursuant to
this final rule shall designate the ``period of time or circumstances
under which the introduction of any persons or class of persons into
the United States shall be suspended.'' It would be unwise to state a
specific time period in this final rule because the epidemiology of
quarantinable communicable diseases varies.
HHS/CDC respectfully disagrees with the comment calling for
``objective review conducted by an agency inspector general or Federal
third-party agency.'' The Secretary delegated his or her statutory
authority under section 362 to the CDC Director, which was proper. HHS/
CDC is best positioned to review the necessity of its own orders.
Moreover, HHS/CDC's core mission is to develop and apply disease
prevention and control strategies to improve the health of all
Americans while it also works to ensure domestic preparedness,
eliminate disease, and end epidemics.\182\ HHS/CDC has the scientific
and technical expertise required to determine whether the existence of
a quarantinable communicable disease in a foreign country or place
poses a serious danger to the United States, whether that serious
danger is increased by the introduction of persons from such country,
and whether a prohibition on the introduction of such persons should be
imposed or continued.
---------------------------------------------------------------------------

\182\ Mission Statement, Ctrs. for Disease Control & Prevention,
https://www.cdc.gov/about/organization/cio-orgcharts/pdfs/CDCfs-508.pdf (last visited Sep. 1, 2020).
---------------------------------------------------------------------------

By contrast, the mission of the HHS Office of the Inspector General
(OIG) ``is to provide objective oversight to promote the economy,
efficiency, effectiveness, and integrity of HHS programs, as well as
the health and welfare of the people they serve.'' \183\ OIG conducts
and supervises audits and investigations relating to certain programs
and operations and provides a means for keeping the Secretary and
Congress informed of problems and deficiencies relating to the
administration of HHS programs. See 5 U.S.C. 2, 4. OIG does not have
the statutory authority or scientific or technical expertise required
to make public health judgments about the imposing or continuing of
prohibitions on the introduction of persons.
---------------------------------------------------------------------------

\183\ About OIG, U.S. Dep't. of Health & Human Serv.'s Off. of
the Inspector Gen., https://oig.hhs.gov/about-oig/about-us/index.asp
(last visited Sep. 1, 2020).
---------------------------------------------------------------------------

Additionally, the Director may not subdelegate statutory authority
under section 362 to another Federal department. Federal officials may
subdelegate their authority to subordinates absent evidence of contrary
Congressional intent, but they may not subdelegate to other departments
absent express statutory authority to do so. See U.S. Telecom Ass'n v.
FCC, 359 F.3d 554, 566 (D.C. Cir. 2004); Gentiva Healthcare Corp. v.
Sebelius, 857 F. Supp. 2d 1, 7 (D.D.C. 2012). The Director does not
have express statutory authority to subdelegate statutory authority
under section 362 to another Federal department.
Comment: A number of commenters recommended that the Department add
a fourth requirement to the components of a CDC Order: A statement of
the evidence of the quarantinable communicable disease threat in the
foreign countries (or one or more designated political subdivisions or
regions thereof) or places from which the introduction of persons is
being suspended, on which the CDC Director relies in issuing such
order.
Response: HHS/CDC has considered this comment and decided, for the
reasons explained in the section of this final rule entitled
``Provisions of New Section 71.40,'' to incorporate a modified version
of this requirement in the final rule. Accordingly, section 71.40(c) of
the final rule requires that, in any order issued pursuant to this
final rule, the Director shall include a statement describing the
danger posed by the quarantinable communicable disease in the foreign
country or countries (or one or more designated political subdivisions
or regions thereof) or places from which the introduction of persons is
being suspended. Also, this final rule applies to quarantinable
communicable diseases broadly, not just to COVID-19. So section
71.40(c) requires that the statement describe the danger posed by the
quarantinable communicable disease that led the Director to invoke the
section 362 authority.

Section 71.40(d), Persons To Whom This Section Applies

Comment: A number of commenters stated that previous efforts to
prevent the introduction of persons with active contagious diseases
from entering the U.S. have been based on an examination of the person,
not on the person's membership in a particular group.
Response: These comments are directed to the CDC Order on covered
aliens issued pursuant to the IFR, and not to the IFR or this final
rule. No action can or will be taken under this final rule absent an
order issued by the Director. To the extent these comments are directed
to this final rule, HHS/CDC respectfully disagrees with them. Like the
IFR, this final rule sets forth facially neutral procedures for the
exercise of the 362 authority by the Director. The procedures do not
turn on whether a person is a member of a particular group.
Moreover, the CDC Order on covered aliens issued pursuant to the
IFR prohibits introduction of covered aliens traveling from Canada or
Mexico, regardless of their national origin, who would otherwise be
introduced into the United States. Covered aliens are those who lack
valid travel documents and would otherwise spend material amounts of
time in congregate areas. The CDC Order on covered aliens does not
prohibit the introduction of persons into the United States based on
factors such as race, color, religion, national origin, sex, age, or
disability. Also, the CDC Order on covered aliens, as implemented by
DHS, provides for discretionary, individualized exceptions from the
prohibition on introduction.
Comment: Some commenters stated that HHS/CDC should clarify that
the

[[Page 56455]]

rule applies to persons, regardless of nationality, if they have
travelled from designated countries.
Response: HHS/CDC believes that the final rule's language that it
applies to those ``from designated foreign countries'' states in plain
language that the prohibition of introduction of persons is based on
the country a person is travelling from, and not their nationality.

Section 71.40(f), Exception for U.S. Citizens, U.S. Nationals, and
Lawful Permanent Residents

Comment: Some commenters indicated that this final rule should also
apply to U.S. citizens and LPRs who may be introduced into the United
States during the COVID-19 pandemic. Some commenters further asserted
that the issuance of a rule that applies to some aliens, but not all
persons, may be unconstitutional.
Response: The Director has no present intention to apply the
section 362 authority to U.S. citizens, U.S. nationals, or LPRs in
connection with the COVID-19 pandemic (indeed, the Director has never
intended to do so). This is partly because U.S. citizens, U.S.
nationals, and LPRs generally present to POEs with valid travel
documents, and do not spend material amounts of time in congregate
settings in such facilities. Because U.S. citizens, U.S. nationals, and
LPRs spend less time in congregate settings than covered aliens subject
to the CDC Order on covered aliens issued pursuant to the IFR, they
present lower public health risks in those settings.
Given the complex and important legal and policy questions
presented by the potential application of section 362 to U.S. citizens,
U.S. nationals, and LPRs, HHS/CDC has determined that it would be in
the public interest to provide notice of, and accept comments on, any
regulatory text that HHS/CDC would propose to apply to U.S. citizens,
U.S. nationals, and LPRs in other contexts. Further notice and comment
would enable HHS/CDC to provide the public with a more fulsome
explanation of the potential public health threats and policy
rationales that support the regulatory text without jeopardizing the
ability of HHS/CDC to protect U.S. public health from COVID-19 in the
immediate future.
HHS/CDC maintains that its approach in this final rule is rational
and constitutional.
Comment: Some commenters stated that mariners and airline crews
should be excluded from this rule because prohibiting them from being
introduced into the U.S. could cause serious logistical and safety
issues.
Response: HHS/CDC has considered this comment and appreciates the
concerns raised. Nevertheless, HHS/CDC does not believe it is necessary
to create express regulatory exclusions for mariners and airline crews.
Any order issued pursuant to this final rule would be tailored by the
Director to what public health requires and, to the greatest extent
possible, adhere to U.S. federal policy of facilitating the critical
work of mariners and aircrew. If public health measures such as
quarantine, isolation, conditional release, or social distancing are
adequate to protect public health, then HHS/CDC would take those
measures and not suspend the introduction of such persons.

VI. Alternatives Considered

HHS/CDC has considered a number of alternatives to the final rule.
One alternative that HHS/CDC has considered is rescinding the IFR and
the CDC Order on covered aliens issued pursuant to the IFR, and
foregoing the issuance of this final rule. HHS/CDC has ruled out that
alternative because there is still a serious danger of introduction of
COVID-19 into the United States from Canada and Mexico, and the public
health situation in Mexico remains tenuous. As noted above, quarantine,
isolation, and conditional release are still not workable options on
the scale that would be needed for protecting U.S. public health from
the introduction of COVID-19; Federal quarantine and isolation of
covered aliens would be impracticable, and covered aliens as a
population are not a good fit for public health measures such as
conditional release and recommendations to self-quarantine or self-
isolate. The rescission of the IFR would result in tens of thousands of
covered aliens entering congregate settings each month, which would put
the health of the DHS workforce and the domestic U.S. population at
greater risk, likely increase community transmission of COVID-19 and
new COVID-19 cases in the States in the U.S.-Mexico border region, and
strain the capacity of U.S. health-care systems. There are good reasons
to issue this final rule, especially when the efforts of the domestic
population to avoid congregate settings are considered. The rescission
of the IFR and CDC Order would undercut those efforts, which the
domestic population has undertaken at great personal sacrifice.
HHS/CDC also considered and declined to include procedures in this
final rule that apply to U.S. citizens, U.S. nationals, and LPRs. Such
procedures present complex and important legal and policy issues, and
the Director has no present intention of prohibiting the introduction
of U.S. citizens, U.S. nationals or LPRs into the United States as part
of the response to the COVID-19 pandemic. Further notice and comment
rulemaking on any proposed regulatory text that would apply outside the
COVID-19 context would be in the public interest.

VII. Regulatory Impact Analysis

A. Unfunded Mandates Reform Act

Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded
Mandates Act) (2 U.S.C. 1532) requires that covered agencies prepare a
budgetary impact statement before promulgating a rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of $100
million in 1995 dollars, updated annually for inflation. Currently,
that threshold is approximately $154 million. If a budgetary impact
statement is required, section 205 of the Unfunded Mandates Act also
requires covered agencies to identify and consider a reasonable number
of regulatory alternatives before promulgating a rule. HHS/CDC has
determined that this final rule is not expected to result in
expenditures by state, local, and tribal governments, or by the private
sector, of $154 million or more in any one year because it only
establishes a regulatory mechanism for the exercise of the PHS Act
section 362 suspension authority, which applies primarily against
persons and not state, local, or tribal governments. Accordingly, HHS/
CDC has not prepared a budgetary impact statement or specifically
addressed the regulatory alternatives considered.

B. National Environmental Policy Act (NEPA)

HHS has determined that the amendments to 42 CFR part 71 will not
have a significant impact on the environment.

C. Executive Order 12988: Civil Justice Reform

HHS has reviewed this rule under Executive Order 12988 on Civil
Justice Reform and has determined that this final rule meets the
standard in the Executive Order.

D. Executive Order 13132: Federalism

This final rule has been reviewed under Executive Order 13132,
Federalism. Under 42 U.S.C. 264(e), Federal public health regulations
do not preempt State or local public health regulations, except in the
event of a conflict with the exercise of Federal

[[Page 56456]]

authority. Other than to restate this statutory provision, this
rulemaking does not alter the relationship between the Federal
government and State/local governments as set forth in 42 U.S.C. 264.
The longstanding provision on preemption in the event of a conflict
with Federal authority (42 CFR 70.2) is left unchanged by this
rulemaking. Furthermore, there are no provisions in this regulation
that impose direct compliance costs on State and local governments.
Therefore, HHS/CDC believes that the final rule does not warrant
additional analysis under Executive Order 13132.

E. Plain Language Act of 2010

Under the Plain Language Act of 2010 (Pub. L. 111-274, October 13,
2010, 124 Stat. 2861), executive departments and agencies are required
to use plain language in documents that explain to the public how to
comply with a requirement the Federal government administers or
enforces. HHS/CDC has attempted to use plain language in promulgating
this final rule, consistent with the Federal Plain Writing Act
guidelines.

F. Congressional Review Act and Administrative Procedure Act

The Congressional Review Act (CRA) defines a ``major rule'' as
``any rule that the Administrator of the Office of Information and
Regulatory Affairs (OIRA) of the Office of Management and Budget finds
has resulted in or is likely to result in--(A) an annual effect on the
economy of $100,000,000 or more; (B) a major increase in costs or
prices for consumers, individual industries, Federal, State, or local
government agencies, or geographic regions; or (C) significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic and export
markets.'' 5 U.S.C. 804(2).
OIRA has determined that this final rule is not a ``major rule''
for purposes of the CRA. The actual experience of HHS/CDC with the IFR
and the CDC Order on covered aliens informs the CRA analysis. The IFR,
like this final rule, establishes procedures by which the Director can
issue an administrative order implementing section 362 of the PHS Act.
Neither the IFR nor this final rule can have any economic effect absent
an administrative order.
So far, the only administrative order that the Director has
determined is necessary in the interest of public health is the CDC
Order on covered aliens. That Order is unlikely to have an annualized
effect on the economy of $100,000,000 or more for two reasons. First,
the CDC Order on covered aliens has no direct economic effect. It
applies only to individual persons, and not to commercial entities such
as carriers; restrictions on commercial and passenger carriers have
been imposed by DHS and HHS/CDC under different authorities. Second,
any indirect economic effect is unlikely to equal or exceed
$100,000,000 annualized. The only potential indirect economic effect
identified by HHS/CDC is a reduction in the utilization of the U.S.
health care system by covered aliens. While that reduction helps
protect U.S. public health by lessening the strain on the U.S. health
care system, and preserving finite health care resources for the
domestic population, HHS/CDC's analysis has determined that the dollar
value of the reduced utilization of the U.S. health care system is
unlikely to equal or exceed $100,000,000 annualized.
This year should serve as a benchmark for any future years in which
the Director might find it necessary in the interest of public health
to prohibit the introduction of persons from foreign countries into the
United States. The COVID-19 pandemic is a once-in-a-generation public
health emergency and, as discussed previously, the Federal government
has mitigated the serious danger of the introduction of COVID-19 into
the United States through a wide array of measures. The Director's
exercise of his authority under section 362 of the PHS Act through
issuance of the CDC Order on covered aliens is just one of those
measures. Others include the INA section 212(f) proclamations;
quarantine, isolation, and conditional release; the CDC No Sail Order
for cruise ships; and travel restrictions at land POEs along the U.S.-
Canada and U.S.-Mexico borders. If the Director's exercise of his
authority under section 362 of the PHS Act is unlikely to have an
annual economic effect of $100,000,000 during the COVID-19 pandemic,
then it follows that any future exercise of the section 362 authority
pursuant to this final rule is unlikely to have an annual effect on the
economy of $100,000,000 or more.
The other tests for a ``major rule'' are not met. This final rule
is procedural in nature. It does not impose any cost or price
increases, or have any significant adverse effects on competition,
employment, investment, productivity, innovation, or on the ability of
United States-based enterprises to compete with foreign-based
enterprises in domestic and export markets.
Because this final rule is not a ``major rule'' under the CRA, only
the APA governs the effective date of this final rule. The APA provides
that the publication of a substantive rule shall be made not less than
30 days before its effective date, except ``as otherwise provided by
the agency for good cause found and published with the rule.'' 5 U.S.C.
553(d)(3). This final rule shall become effective 30 days from its
publication in the Federal Register unless the IFR ceases to be in
effect (for example, if it is vacated or enjoined by a court) before
that time, in which case this final rule shall become effective
immediately for good cause. There would be good cause because, as
discussed in earlier sections of this final rule, the procedures
established by the IFR and this final rule are critical to HHS/CDC's
ability to mitigate the serious danger of the introduction of COVID-19
into the United States, and thereby protect U.S. public health.
As discussed previously in this final rule, the Director assesses
that the CDC Order on covered aliens is benefitting U.S. public health
in several ways. The Director assesses that the CDC Order is: Reducing
the danger of the introduction of COVID-19 into CBP facilities, which
protects both the DHS workforce and migrants from COVID-19; reducing
the strain on the health-care system in the U.S.-Mexico border region
by decreasing utilization by covered aliens, which conserves health-
care resources for the domestic population; and helping to slow the
community transmission of COVID-19 and the number of new COVID-19 cases
in the States in the U.S.-Mexico border region, which helps protect the
domestic population from COVID-19. These benefits to U.S. public health
would be lost immediately if the IFR and, by extension, the CDC Order
on covered aliens ceased to be effective.
Of course, there would probably be secondary effects on U.S. public
health and safety. As previously discussed in this final rule, the
Director has assessed that the numbers of CBP employees who test
positive for COVID-19 or enter quarantine would probably be larger
absent the CDC Order, and CBP has informed HHS/CDC that further
degradation of its workforce in the Laredo Sector due to COVID-19 would
jeopardize CBP's ability to execute its public safety mission. Thus,
one likely secondary effect would be further degradation of the CBP
workforce due to COVID-19 and, according to CBP, a corresponding
reduction in public safety in the Laredo Sector. Similar effects would
be possible in other sectors.

[[Page 56457]]

States in the U.S-Mexico border region would probably also
experience secondary effects. As previously discussed in this final
rule, the Director has assessed that increased community transmission
in California and Arizona would likely result in increased numbers of
cases, as well as increased case and positivity rates, and ultimately
increased numbers of individuals who have serious outcomes. Increases
in case and positivity rates would, in turn, frustrate efforts in those
States to step down to lower tiers in the reopening guidelines. The
Director has further assessed that the introduction of covered aliens
into California and Arizona through congregate settings in CBP
facilities would likely have a negative impact on case and positivity
rates in California and Arizona, which would not be in the interest of
U.S. public health. Similar secondary effects would be possible in
other States in the U.S.-Mexico border region such as Texas.
It is also foreseeable that the Federal government might have to
address secondary effects in ICE facilities or ORR shelters for
migrants. If, for example, the numbers of migrants entering those
facilities were to increase, then the Federal government would have to
attempt to manage the intake of the new migrants consistent with HHS/
CDC infection control guidelines in order to help protect the health of
the migrants, the facility workforces, and the U.S. domestic
population. DHS and ORR report that the operationalizing of such
guidelines is more complex than their ordinary operations. It is
possible that facility censuses could reach or exceed levels that are
workable under HHS/CDC infection control guidelines, in which case HHC/
CDC may be left with no workable options for protecting U.S. public
health.
HHS/CDC does not reasonably anticipate factual changes in the next
30 days that would materially affect HHS/CDC's good cause
analysis.\184\ While HHS/CDC modeling predicts that the total new
deaths from COVID-19 will continue to decrease in September 2020, HHS/
CDC reasonably anticipates that community transmission and the rates of
new COVID-19 cases will remain serious concerns with respect to DHS,
ORR, and the States in the U.S.-Mexico border region. For the next 30
days, any temporary loss of the procedures established by the IFR would
jeopardize HHS/CDC's ability to protect U.S. public health from COVID-
19 and other quarantinable communicable diseases. As a result, there
would be good cause for this final rule to become effective immediately
in the event that the IFR ceases to be in effect.
---------------------------------------------------------------------------

\184\ COVID-19 Forecasts: Deaths, Ctrs. for Disease Control &
Prevention, https://www.cdc.gov/coronavirus/2019-ncov/covid-data/forecasting-us.html (last updated Sep. 2, 2020).
---------------------------------------------------------------------------

There would be no prejudice to the public if the final rule became
effective immediately. The final rule, like the IFR, permits the
Director to prohibit the introduction into the United States of persons
from designated foreign countries (or one or more political
subdivisions or regions thereof) or places, only for such period of
time that the Director deems necessary to avert the serious danger of
the introduction of a communicable disease, by issuing an order in
which the Director determines that:
(1) By reason of the existence of any quarantinable communicable
disease in a foreign country (or one or more political subdivisions or
regions thereof) or place there is serious danger of the introduction
of such quarantinable communicable disease into the United States; and
(2) This danger is so increased by the introduction of persons from
such country (or one or more political subdivisions or regions thereof)
or place that a suspension of the right to introduce such persons into
the United States is required in the interest of public health.
While the final rule mirrors the IFR at its core, the final rule is
narrower than the IFR, clarifies aspects of the regulatory procedures,
and enhances public transparency. Notably, the final rule applies only
to quarantinable communicable diseases, which are a subset of
communicable diseases specified by the President in Executive Orders.
The final rule also: aligns the regulatory text with section 362 of the
PHS Act; defines additional terms; and requires the Director, when
issuing an administrative order, to state both the means by which the
prohibition on introduction shall be implemented, and the serious
danger posed by the introduction of the quarantinable communicable
disease. These changes would be beneficial, not prejudicial, to the
public.

G. Executive Orders 12866 and 13563 and Regulatory Flexibility Act

Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, and public
health and safety effects; distributive impacts; and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Section 3(f) of Executive Order 12866 defines a ``significant
regulatory action'' as an action that is likely to result in a
regulation (1) having an annual effect on the economy of $100 million
or more in any one year, or adversely and materially affecting a sector
of the economy, productivity, competition, jobs, the environment,
public health or safety, or State, local, or tribal governments or
communities (also referred to as ``economically significant''); (2)
creating a serious inconsistency or otherwise interfering with an
action taken or planned by another agency; (3) materially altering the
budgetary impacts of entitlement grants, user fees, or loan programs or
the rights and obligations of recipients thereof; or (4) raising novel
legal or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order. This
final rule is not economically significant for the purposes of
Executive Orders 12866 and 13563 for the same reasons that it is not a
major rule for purposes of the CRA. The Office of Management and Budget
(OMB) has reviewed this rule.
The Regulatory Flexibility Act (RFA) generally requires that when
an agency issues a proposed rule, or a final rule pursuant to section
553(b) of the APA or another law, the agency must prepare a regulatory
flexibility analysis that meets the requirements of the RFA and publish
such analysis in the Federal Register. 5 U.S.C. 603, 604. Specifically,
the RFA normally requires agencies to describe the impact of a
rulemaking on small entities by providing a regulatory impact analysis.
Such analysis must address the consideration of regulatory options that
would lessen the economic effect of the rule on small entities. The RFA
defines a ``small entity'' as (1) a proprietary firm meeting the size
standards of the Small Business Administration (SBA); (2) a nonprofit
organization that is not dominant in its field; or (3) a small
government jurisdiction with a population of less than 50,000. 5 U.S.C.
601(3)-(6). Except for such small government jurisdictions, neither
State nor local governments are ``small entities.'' Similarly, for
purposes of the RFA, persons are not small entities. The requirement to
conduct a regulatory impact analysis does not apply if the head of the
agency ``certifies that the rule will not, if promulgated,

[[Page 56458]]

have a significant economic impact on a substantial number of small
entities.'' 5 U.S.C. 605(b). The agency must, however, publish the
certification in the Federal Register at the time of publication of the
rule, ``along with a statement providing the factual basis for such
certification.'' Id. If the agency head has not waived the requirements
for a regulatory flexibility analysis in accordance with the RFA's
waiver provision, and no other RFA exception applies, the agency must
prepare the regulatory flexibility analysis and publish it in the
Federal Register at the time of promulgation or, if the rule is
promulgated in response to an emergency that makes timely compliance
impracticable, within 180 days of publication of the final rule. 5
U.S.C. 604(a), 608(b).
HHS/CDC certifies that this final rule will not have a significant
economic impact on a substantial number of small entities. This final
rule establishes a regulatory procedure by which the Director may
exercise the section 362 authority through issuance of an
administrative order. Without an administrative order, this final rule
can have no economic impact.
HHS/CDC may use the procedures created by this final rule to issue
administrative orders against individual persons. In addition, HHS/CDC
may use the procedures created by this final rule to issue
administrative orders against carriers of persons, such as cruise ships
or airlines. HHS/CDC, however, does not reasonably contemplate issuing
administrative orders against carriers of persons that are small
entities for two reasons. First, small entities are by their nature
less likely than large entities to transport large numbers of persons
in congregate settings. Second, based on experience, HHS/CDC reasonably
contemplates mitigating the public health risks presented by carriers
that are small entities through less sweeping public health measures,
such as quarantine, isolation, and conditional release, or no-sail
orders issued under other procedures, or no-fly lists of passengers.
HHS/CDC reasonably contemplates that any administrative orders against
carriers would be rare, and would be limited to large entities
transporting large numbers of persons in congregate settings.
Accordingly, HHS/CDC certifies that this final rule will not have a
significant economic impact on a substantial number of small entities
when considered together with any administrative order that HHS/CDC
could conceivably issue in the future.

H. Assessment of Federal Regulation and Policies on Families

Section 654 of the Treasury and General Government Appropriations
Act of 1999, Public Law 105-277, sec. 654, 112 Stat. 2681 (1998)
requires Federal departments and agencies to determine whether a policy
or regulation could affect family well-being. HHS/CDC conducts such an
analysis below and certifies the same.
Section 601 (note) required agencies to assess whether a regulatory
action (1) impacted the stability or safety of the family, particularly
in terms of marital commitment; (2) impacted the authority of parents
in the education, nurturing, and supervision of their children; (3)
helped the family perform its functions; (4) affected disposable income
or poverty of families and children; (5) was justified if it
financially impacted families; (6) was carried out by State or local
government or by the family; and (7) established a policy concerning
the relationship between the behavior and personal responsibility of
youth and the norms of society.
This final rule establishes the process by which the Director may
issue administrative orders suspending the introduction of persons.
Standing alone, without an administrative order from the Director, it
has no direct impact on family well-being based on any of the factors
listed above. If the family well-being determination requirement were
still in force, an assessment of the impact of this final rule on
family well-being would not be required.
The current CDC Order on covered aliens does not implicate factors
(2) through (7) listed above. HHS/CDC, however, recognizes that the
current CDC Order on covered aliens, and future orders by the Director,
could potentially impact family stability under factor (1). This is
because such orders temporarily prevent persons from introducing
themselves into the United States and, as a consequence, may prevent
the persons from seeing family members in the United States. Any such
impact on family well-being would last for the duration of the order.
In the judgment of HHS/CDC, the benefits to U.S. public health that
flow from preventing the introduction of quarantinable communicable
diseases into the United States far outweigh any impact on family well-
being that might result from deferred visitation of family members in
the United States. Families benefit greatly when family members--
particularly seniors and other members of vulnerable populations--are
healthy and safe from quarantinable communicable diseases. The
suffering and loss of family members due to disease is tragic, and the
burden of caring for family members with serious disease may be
emotionally and financially significant. The better approach overall
for protecting family well-being is to reduce the danger of
quarantinable communicable diseases, notwithstanding any temporary
deferral of visitation.

I. Paperwork Reduction Act of 1995

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3506; 5 CFR 1320 Appendix A.1), HHS has reviewed this final rule and
has determined that there are no new collections of information
contained therein.

J. Regulatory Reform Analysis Under Executive Order 13771

Executive Order 13771, titled ``Reducing Regulation and Controlling
Regulatory Costs,'' was issued on January 30, 2017, and requires that
the costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations.'' OMB's Guidance
Implementing Executive Order 13771, Titled ``Reducing Regulation and
Controlling Regulatory Costs,'' issued on April 5, 2017, (https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/M-17-21-OMB.pdf), explains that ``E.O. 13771 deregulatory actions are not
limited to those defined as significant under E.O. 12866 or OMB's Final
Bulletin on Good Guidance Practices.'' It has been determined that this
proposed rule imposes no more than de minimis costs, and therefore is
not considered a regulatory action under Executive Order 13771.

List of Subjects in 42 CFR Part 71

Apprehension, Communicable diseases, Conditional release, CDC, Ill
person, Isolation, Non-invasive, Public health emergency, Public health
prevention measures, Qualifying stage, Quarantine, Quarantinable
communicable disease.

For the reasons set forth in the preamble, 42 CFR part 71 is
amended as follows:

PART 71--FOREIGN QUARANTINE

0
1. The authority citation for part 71 continues to read as follows:

Authority: Secs. 215 and 311 of the Public Health Service (PHS)
Act, as amended (42 U.S.C. 216, 243); secs. 361-369, PHS Act, as
amended (42 U.S.C. 264-272).

0
2. Revise Sec. 71.40 to read as follows

[[Page 56459]]

Sec. 71.40 Suspension of the right to introduce and prohibition of
the introduction of persons into the United States from designated
foreign countries or places for public health purposes.

(a) The Director may prohibit, in whole or in part, the
introduction into the United States of persons from designated foreign
countries (or one or more political subdivisions or regions thereof) or
places, only for such period of time that the Director deems necessary
to avert the serious danger of the introduction of a quarantinable
communicable disease, by issuing an order in which the Director
determines that:
(1) By reason of the existence of any quarantinable communicable
disease in a foreign country (or one or more political subdivisions or
regions thereof) or place there is serious danger of the introduction
of such quarantinable communicable disease into the United States; and
(2) This danger is so increased by the introduction of persons from
such country (or one or more political subdivisions or regions thereof)
or place that a suspension of the right to introduce such persons into
the United States is required in the interest of public health.
(b) For purposes of this section:
(1) Introduction into the United States means the movement of a
person from a foreign country (or one or more political subdivisions or
regions thereof) or place, or series of foreign countries or places,
into the United States so as to bring the person into contact with
persons or property in the United States, in a manner that the Director
determines to present a risk of transmission of a quarantinable
communicable disease to persons, or a risk of contamination of property
with a quarantinable communicable disease, even if the quarantinable
communicable disease has already been introduced, transmitted, or is
spreading within the United States;
(2) Prohibit, in whole or in part, the introduction into the United
States of persons means to prevent the introduction of persons into the
United States by suspending any right to introduce into the United
States, physically stopping or restricting movement into the United
States, or physically expelling from the United States some or all of
the persons;
(3) Serious danger of the introduction of such quarantinable
communicable disease into the United States means the probable
introduction of one or more persons capable of transmitting the
quarantinable communicable disease into the United States, even if
persons or property in the United States are already infected or
contaminated with the quarantinable communicable disease;
(4) The term Place includes any location specified by the Director,
including any carrier, as that term is defined in 42 CFR 71.1, whatever
the carrier's flag, registry, or country of origin; and
(5) Suspension of the right to introduce means to cause the
temporary cessation of the effect of any law, rule, decree, or order
pursuant to which a person might otherwise have the right to be
introduced or seek introduction into the United States.
(c) Any order issued by the Director under this section shall
include a statement of the following:
(1) The foreign countries (or one or more political subdivisions or
regions thereof) or places from which the introduction of persons shall
be prohibited;
(2) The period of time or circumstances under which the
introduction of any persons or class of persons into the United States
shall be prohibited;
(3) The conditions under which that prohibition on introduction
shall be effective in whole or in part, including any relevant
exceptions that the Director determines are appropriate;
(4) The means by which the prohibition shall be implemented; and
(5) The serious danger posed by the introduction of the
quarantinable communicable disease in the foreign country or countries
(or one or more political subdivisions or regions thereof) or places
from which the introduction of persons is being prohibited.
(d) When issuing any order under this section, the Director shall,
as practicable under the circumstances, consult with all Federal
departments or agencies whose interests would be impacted by the order.
The Director shall, as practicable under the circumstances, provide the
Federal departments or agencies with a copy of the order before issuing
it. In circumstances when it is impracticable to engage in such
consultation before taking action to protect the public health, the
Director shall consult with the Federal departments or agencies as soon
as practicable after issuing his or her order, and may then modify the
order as he or she determines appropriate. In addition, the Director
may, as practicable under the circumstances, consult with any State or
local authorities that he or she deems appropriate in his or her
discretion.
(1) If the order will be implemented in whole or in part by State
and local authorities who have agreed to do so under 42 U.S.C. 243(a),
then the Director shall explain in the order the procedures and
standards by which those authorities are expected to aid in the
enforcement of the order.
(2) If the order will be implemented in whole or in part by
designated customs officers (including any individual designated by the
Department of Homeland Security to perform the duties of a customs
officer) or Coast Guard officers under 42 U.S.C. 268(b), or another
Federal department or agency, then the Director shall, in coordination
with the Secretary of Homeland Security or other applicable Federal
department or agency head, explain in the order the procedures and
standards by which any authorities or officers or agents are expected
to aid in the enforcement of the order, to the extent that they are
permitted to do so under their existing legal authorities.
(e) This section does not apply to:
(1) Members of the armed forces of the United States and associated
personnel if the Secretary of Defense provides assurance to the
Director that the Secretary of Defense has taken or will take measures
such as quarantine or isolation, or other measures maintaining control
over such individuals, to prevent the risk of transmission of the
quarantinable communicable disease into the United States; or
(2) Other United States government employees or contractors on
orders abroad, or their accompanying family members who are on their
orders or are members of their household, if the Director receives
assurances from the relevant head of agency and determines that the
head of the agency or department has taken or will take, measures such
as quarantine or isolation, to prevent the risk of transmission of a
quarantinable communicable disease into the United States.
(f) This section shall not apply to U.S. citizens, U.S. nationals,
and lawful permanent residents.

[[Page 56460]]

(g) Any provision of this section held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give the maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this section and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.

Dated: September 4, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-20036 Filed 9-4-20; 5:15 pm]
BILLING CODE 4163-18-P