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, 56424-56460 [2020-20036]

Download as PDF 56424 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Final rule. AGENCY: 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. SUMMARY: 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 VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 & 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). 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 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 reestablished in 1987, the Secretary of HHS has retained the authorities previously held by the Surgeon General. E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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: (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 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). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 56425 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 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 E:\FR\FM\11SER3.SGM Continued 11SER3 56426 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 granted to an alien only upon such terms as the United States shall prescribe.’’). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 24hour 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 selfquarantine 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 selfquarantine 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 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 inperson visits by a health official or designee, telephone, or through any electronic or internetbased means as determined by the Director. PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 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. The issuance of conditional release orders, or recommendations to selfisolate 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 E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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. HHS/CDC actions regarding cruise ships are another example of how preventing the movement of potentially 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-correctionaldetention.html (last updated Jul. 22, 2020). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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.’’ 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, 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)). 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). PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 56427 prohibition of the introduction of persons under section 362, or some combination of the two. 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 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 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/riskassessment.html (last updated Aug. 6, 2020). 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). E:\FR\FM\11SER3.SGM 11SER3 56428 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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. 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 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:// VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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. 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. 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 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. 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). PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 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 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 While much is still unknown about the transmission of COVID–19, it is 20 WHO Director-General’s statement on IHR Emergency Committee on Novel Coronavirus (2019nCoV) (Jan. 30, 2020), WHO, https://www.who.int/ dg/speeches/detail/who-director-general-sstatement-on-ihr-emergency-committee-on-novelcoronavirus-(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-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/. 23 WHO Sit. Rep. 205 (Aug. 24, 2020), WHO, https://www.who.int/docs/default-source/ coronaviruse/situation-reports/20200812-covid-19sitrep-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/fssars.html (last updated Dec. 6, 2017). 25 MERS situation update, January 2020, WHO, https://www.emro.who.int/pandemic-epidemicdiseases/mers-cov/mers-situation-update-january2020.html (last visited Aug. 27, 2020). 26 Influenza (Flu): 2009 H1N1 Pandemic (H1N1pdm09 virus), Ctrs. for Disease Control & Prevention, https://www.cdc.gov/flu/pandemicresources/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). E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 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 Early data suggest older people are more likely to have serious COVID–19 illness, with 8 out of 10 COVID–19related deaths in the United States being 28 COVID–19 Pandemic Planning Scenarios: Updated July 10, 2020, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/coronavirus/2019ncov/hcp/planning-scenarios-h.pdf. 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%2F www.cdc.gov%2Fcoronavirus%2F2019ncov%2Fneed-extra-precautions%2Fgroups-athigher-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). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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. 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 crossborder 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 StatesMexico 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 33 Coronavirus Disease 2019 (COVID–19): Older Adults, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/coronavirus/2019-ncov/needextra-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-HomeData/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-19sitrep-209.pdf?sfvrsn=5dde1ca2_2. PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 56429 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 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-toperson transmission of COVID–19, the President reduced the number of infected persons who could enter the country. As previously discussed, a 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 § 212 (f) (May 4, 2020) (available at: https://crsreports.congress.gov/product/pdf/LSB/ LSB10458). E:\FR\FM\11SER3.SGM 11SER3 56430 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 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 infectionprevention 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 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/t01312019-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-governmentdepartments-take-coronavirus-response-measures/. 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). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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. 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 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. 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-australia51999845. 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. PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 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. 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 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). E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations re-deploy the NDMS to other emergencies (e.g., hurricanes). 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 decisionmaking 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 48 No Sail Order and Suspension of Further Embarkation, 85 FR 16628 (Mar. 24, 2020). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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. 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 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). 51 85 FR at 16629, 16630. PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 56431 lead to transmission on sequential cruises, as the crew members work and live in close quarters from one cruise to the next.52 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 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 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 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 52 Id. 53 Id. at 16629. at 16630. 54 Id. 55 Id. E:\FR\FM\11SER3.SGM 11SER3 56432 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 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 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.aapaports.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. VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 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 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. 57 85 FR at 16547, 16549. at 16548–49. 59 85 FR at 51633–34. 60 Id. at 51633, 51635. 58 Id. PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 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. 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 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’’). 65 Id. at 31504. E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 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 66 Id. 67 Id. VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 75day 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 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 PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 56433 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 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 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. E:\FR\FM\11SER3.SGM 11SER3 56434 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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. 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 midJuly 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 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. 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-19icu-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-valleyhospitals/. 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/ PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 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. 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. 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 arizona-health/2020/07/14/arizona-coronavirusupdate-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-hospitalscoronavirus-surge-california. 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-andtransportation-during-coronavirus-pandemic/traveland-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-travelrestrictions.html. E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations Commission, on March 17, 2020, EU Member States agreed to restrict nonessential travel across the EU’s external border for a period that has now been extended several times.76 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 On June 11, 2020, the European Commission adopted a Communication 80 which set out an 76 Travel and transportation during the coronavirus pandemic: Travel restrictions, Eur. Comm’n, https://ec.europa.eu/info/live-work-traveleu/health/coronavirus-response/travel-andtransportation-during-coronavirus-pandemic/traveland-eu-during-pandemic_en (last visited Aug. 31, 2020). 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-traveleu/health/coronavirus-response/travel-andtransportation-during-coronavirus-pandemic/traveland-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). 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 VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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-athome orders, closures of schools and nonessential businesses, and face mask ordinances. 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 (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-transportationduring-coronavirus-pandemic/travel-and-eu-duringpandemic_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-ofcountries-for-mandatory-14-day-isolation-uponreturn-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). 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-andtransportation-during-coronavirus-pandemic/traveland-eu-during-pandemic_en (last visited Aug. 31, 2020). 85 Id. PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 56435 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 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 86 These countries are: Australia, Canada, Georgia, Japan, New Zealand, Rwanda, South Korea, Thailand, Tunisia, Uruguay, and China (subject to confirmation of reciprocity). Id. 87 Media Statement, Prime Minister of Australia announces Border Restrictions (Mar. 19, 2020) (available at: https://www.pm.gov.au/media/borderrestrictions). 88 Id.; COVID–19 and the border: Travel restrictions, Cmlth. of Austl, Dep’t of Home Aff., https://covid19.homeaffairs.gov.au/travelrestrictions-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: E:\FR\FM\11SER3.SGM Continued 11SER3 56436 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 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 https://www.pm.gov.au/media/national-cabinet7aug2020) 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). 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-27august-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-healthprotection-principal-committee-ahppc-statementon-the-safe-return-of-crowds-to-stadiums-arenasand-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-primeministers-jacinda-ardern-and-scott-morrisonannounce-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/transtasman-travel-bubble-on-pause-amid-new-covidoutbreaks-across-pacific. 95 See Media Statement, National Cabinet discusses Australia’s current COVID–19 response, VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 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 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-restrictions1159pm-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-covid19/premiers-statement-changes-regionalrestrictions. 98 See e.g., Travel Restrictions, S. Austl. St. Gov’t, https://www.covid-19.sa.gov.au/restrictions-andresponsibilities/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/borderrestrictions#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. 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). PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 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 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 New Zealand’s so-called elimination strategy for COVID–19, consisting of border controls, case detection and surveillance, and contact tracing and 101 Id. 102 COVID–19: Key updates, N.Z. Immigration, https://www.immigration.govt.nz/about-us/covid19/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-refugeesand-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-resettlementstrategy/rqip (last visited Aug. 28, 2020). 104 COVID–19: New Zealanders in the UK— Frequently Asked Questions, N.Z. Foreign Aff. & Trade, https://www.mfat.govt.nz/en/countries-andregions/europe/united-kingdom/new-zealand-highcommission/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), https://www.legislation.govt.nz/regulation/ public/2020/0134/latest/whole.html#LMS363210. E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 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 nonessential travel along the United StatesCanada land border.111 As noted above, these measures were extended through September 21, 2020.112 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 108 See COVID–19: Elimination strategy for Aotearoa New Zealand, Ministry of Health, https:// www.health.govt.nz/our-work/diseases-andconditions/covid-19-novel-coronavirus/covid-19current-situation/covid-19-elimination-strategyaotearoa-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-asia53274085; 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-ssome-countries-have-just-about-halted-it11594037814. 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-zealandselimination-strategy-for-the-covid-19-pandemicand-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-covid19). 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-furtherspread-coronavirus (last updated Aug. 14, 2020). 112 85 FR 51634 (August 21, 2020). 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-requirementsunder-the-quarantine-act-for-anyone-enteringcanada.html), (last updated July 3, 2020). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 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 crossborder 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. While Canada was slower to implement public health restrictions on 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/immigrationrefugees-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-novelcoronavirus-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-refugeescitizenship/services/coronavirus-covid19/travelrestrictions-exemptions.html (last updated Aug. 13, 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-healthofficer-of-canada-on-august-27-2020.html (last updated August 27, 2020). PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 56437 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. 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 119 85 FR 16559 (March 24, 2020). v. Wolf, No. 20–cv–02245–EGS, at *27–28 (D.D.C. Aug. 14, 2020), ECF No. 1. 120 P.J.E.S. E:\FR\FM\11SER3.SGM 11SER3 56438 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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. 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 VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 influenzalike 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 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 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). PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 per 100,000 people over that same period.125 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 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, 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-datatracker/#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). 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-inResponse-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-inResponse-to-COVID-19.aspx (last updated July 17, 2020). 128 Id. E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 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 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 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. 133 State Officials Anounce Latest COVID–19 Facts, Cal. Dep’t. of Pub. Health, https:// www.cdph.ca.gov/Programs/OPA/Pages/NR20213.aspx (last updated Aug. 30, 2020). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 and positivity rates would, in turn, frustrate efforts by California counties to step down to lower tiers in the reopening guidelines and begin inperson 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 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 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/furtheraction-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-gallegoconcerns-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/healthexperts-link-rise-in-arizona-coronavirus-cases-toend-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-coronaviruscases-worst-in-united-states. 138 State Reports, White House Coronavirus Task Force, *17–23 (July 26, 2020) (on file with HHS). 139 Id. See Data Dashboard, Ariz. Dep’t of Health Serv.’s, https://www.azdhs.gov/preparedness/ epidemiology-disease-control/infectious-diseaseepidemiology/covid-19/dashboards/index.php (last visited Aug. 31, 2020) (see ‘‘Hospital Bed Usage & Availability’’ tab). PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 56439 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 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 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-amidcoronavirus-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-500additional-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-diseaseepidemiology/novel-coronavirus/sdmac/sdmacguidance-crisis-standards-care-healthcarefacilities.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/responseplans/azcsc-plan.pdf). 142 Data Dashboard, Ariz. Dep’t of Health Serv.’s, https://www.azdhs.gov/preparedness/epidemiologydisease-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’’). 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-diseaseepidemiology/novel-coronavirus/businessbenchmarks.pdf) (last updated Aug. 27, 2020). 144 Id. E:\FR\FM\11SER3.SGM 11SER3 56440 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations are experiencing substantial transmission, during which all businesses must remained closed.145 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 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 145 Id. 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. VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 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. 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-coronavirusmexico-idUSKCN24R0K5. PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 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 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 149 An Act relative to Quarantine, ch. 31, 1 Stat. 474 (May 27, 1796). 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). E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations ‘‘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). 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 vesselspecific 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 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, VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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. 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 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 67 F. 1, 4 (8th Cir. 1895) (discussing an ‘‘intervener who introduces himself into a pending action in a state court’’) (emphasis added). 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’’). PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 56441 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). 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 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.’’). E:\FR\FM\11SER3.SGM 11SER3 56442 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 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 157 Exec. Order No. 5143 (June 21, 1929). 158 Id. 159 Id. VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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. 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 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). PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 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 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. 161 Exec. E:\FR\FM\11SER3.SGM Order No. 5143 (June 21, 1929). 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 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). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 customs officers from DHS have assisted CDC in implementing the CDC Order on covered aliens. 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 PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 56443 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. 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. 164 Exec. Order 13295 (Apr. 4, 2003), as amended by Exec. Order 13375 (Apr. 1, 2005) and Exec. Order 13674 (July 31, 2014). E:\FR\FM\11SER3.SGM 11SER3 56444 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 [] 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 VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 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 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’’). E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations ‘‘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. 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); VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 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). PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 56445 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.’’ 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. 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 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’’). 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’’). E:\FR\FM\11SER3.SGM 11SER3 56446 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 169 Serious, Universal English Dictionary 661 (John Craig ed. 1869). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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. 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. 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). PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 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 crossborder 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. 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 171 42 CFR Sec. 71.1 defines ‘‘carrier’’ to mean ‘‘a ship, aircraft, train, road vehicle, or other means of transport, including military.’’ E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 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 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’’). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 56447 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 E:\FR\FM\11SER3.SGM 11SER3 56448 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 173 85 FR 16559, 16564 (Mar. 24, 2020). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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.’’ 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 PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 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, E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 56449 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. E:\FR\FM\11SER3.SGM 11SER3 56450 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 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 VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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’’). 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 72hour 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 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). PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 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 E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 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 VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 under Title 42 are not processed for immigration enforcement actions. 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 legalsuccessor 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 § 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-selfexecuting. See Khan v. Holder, 584 F.3d 773, 783 (9th Cir. 2009) (‘‘[T]he [Refugee] Protocol is not selfexecuting.’’); 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 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. PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 56451 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, § 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 nonrefoulement 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 E:\FR\FM\11SER3.SGM 11SER3 56452 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations United States has implemented the nonrefoulement obligation under the 1967 Protocol by enacting the withholding-ofremoval 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 VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 selfisolate 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, PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 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 selfquarantine 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 selfquarantine 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 selfquarantine 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 asylumseekers, 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 selfisolation protocols. For such orders or 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. E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations protocols to be effective, persons who HHS/CDC temporarily apprehends and then conditionally releases with orders—or, alternatively, persons to whom HHS/CDC recommends selfquarantine 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. 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. Several commenters asserted that HHS/CDC should nevertheless allow covered aliens to self-quarantine or selfisolate 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 178 Quarantine and Isolation: U.S. Quarantine Stations, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/quarantine/quarantinestations-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. 180 USIPC is a part of the University of California San Diego (UC San Diego) that ‘‘brings together leading academics, policy analysts, immigrantrights leaders, and policymakers across all levels of government to conceptualize, debate, and design a new U.S. immigration policy agenda . . . .’’ U.S. VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 selfquarantine or self-isolation locations. Nor did USIPC look at whether residences were suitable for selfquarantine or self-isolation in compliance with HHS/CDC guidelines.181 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 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/ (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-whensick.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/2019ncov/if-you-are-sick/quarantine.html (last updated Aug. 16, 2020). When at home, persons in selfquarantine 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/dailylife-coping/checklist-household-ready.html (last updated June 13, 2020). PO 00000 Frm 00031 Fmt 4701 Sfmt 4700 56453 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 E:\FR\FM\11SER3.SGM 11SER3 56454 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 182 Mission Statement, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/about/ VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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. 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. 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 organization/cio-orgcharts/pdfs/CDCfs-508.pdf (last visited Sep. 1, 2020). 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). PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 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 E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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. VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 PO 00000 Frm 00033 Fmt 4701 Sfmt 4700 56455 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 E:\FR\FM\11SER3.SGM 11SER3 56456 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 foreignbased 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 VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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. PO 00000 Frm 00034 Fmt 4701 Sfmt 4700 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. E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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 184 COVID–19 Forecasts: Deaths, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/ coronavirus/2019-ncov/covid-data/forecastingus.html (last updated Sep. 2, 2020). VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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. 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 PO 00000 Frm 00035 Fmt 4701 Sfmt 4700 56457 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, E:\FR\FM\11SER3.SGM 11SER3 56458 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations 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. VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 wellbeing. 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 wellbeing determination requirement were still in force, an assessment of the impact of this final rule on family wellbeing 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 PO 00000 Frm 00036 Fmt 4701 Sfmt 4700 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 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). ■ 2. Revise § 71.40 to read as follows E:\FR\FM\11SER3.SGM 11SER3 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations § 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 VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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 PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 56459 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. E:\FR\FM\11SER3.SGM 11SER3 56460 Federal Register / Vol. 85, No. 177 / Friday, September 11, 2020 / Rules and Regulations (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 VerDate Sep<11>2014 19:43 Sep 10, 2020 Jkt 250001 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. PO 00000 Frm 00038 Fmt 4701 Sfmt 9990 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 E:\FR\FM\11SER3.SGM 11SER3

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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: 
[email protected].

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.'').

---------------------------------------------------------------------------

[[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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.''
---------------------------------------------------------------------------

    \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)).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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/.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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, https://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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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\
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    \51\ 85 FR at 16629, 16630.
    \52\ Id. at 16629.
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    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\
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    \53\ Id. at 16630.
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    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\
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    \54\ Id.
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    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\
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    \55\ Id.
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    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\
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    \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.
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    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\
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    \57\ 85 FR at 16547, 16549.
    \58\ Id. at 16548-49.
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    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\
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    \59\ 85 FR at 51633-34.
    \60\ Id. at 51633, 51635.
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    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.
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    \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'').
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    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\
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    \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\
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    \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.
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    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.
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    \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.
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    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.
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    \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.
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    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.
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    \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.
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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\
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    \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\
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    \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).
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    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).
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    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\
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    \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), https://www.legislation.govt.nz/regulation/public/2020/0134/latest/whole.html#LMS363210.
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    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\
---------------------------------------------------------------------------

    \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\
---------------------------------------------------------------------------

    \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\
---------------------------------------------------------------------------

    \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/ 
(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).
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    \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).
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    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.
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    \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.
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    \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.
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    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.
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    \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/ (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

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