I. Executive Summary
A. Purpose of the Action
B. Summary of Major Provisions
C. Summary of Costs and Benefits
II. Public Participation
III. Background
A. Legal Authority
B. Regulatory History
IV. Summary of the Final Rule
A. General References to “CDC” and “Director” in Parts 70 and 71
B. Definitions ( § § 70.1 and 71.1(b))
C. Apprehension and Detention of Persons With Quarantinable Communicable Diseases
(70.6)
D. Medical Examinations ( § § 70.12 and 71.36)
E. Requirements Relating to the Issuance of a Federal Order for Quarantine, Isolation,
or Conditional Release ( § § 70.14 and 71.37)
F. Mandatory Reassessment of a Federal Order for Quarantine, Isolation, or Conditional
Release ( § § 70.15 and 71.38)
G. Medical Review of a Federal Order for Quarantine, Isolation, or Conditional Release
( § § 70.16 and 71.39)
H. Administrative Records Relating to a Federal Order for Quarantine, Isolation, or
Conditional Release ( § § 70.17 and 71.29)
I. Payment for Care and Treatment (70.13 and 71.30)
J. Agreements ( § § 70.18 and 71.40)
K. Penalties ( § § 70.18 and 71.2)
L. Public Health Prevention Measures To Detect Communicable Disease ( § § 70.10 and
71.20)
M. Requirements Relating to Travelers Under a Federal Order of Isolation, Quarantine,
or Conditional Release ( § 70.5)
N. Report of Death or Illness Onboard Aircraft Operated by an Airline ( § 70.11)
O. Requirements Relating to Collection, Storage, and Transmission of Airline and Vessel
Passenger, Crew, and Flight and Voyage Information for Public Health Purposes ( §
§ 71.4 and 71.5)
P. Requirements Relating to Collection, Storage, and Transmission of Airline and Vessel
Passenger, Crew, and Flight and Voyage Information for Public Health Purposes ( §
§ 71.4 and 71.5)
Q. Report of Death or Illness ( § 71.21)
V. Overview of Public Comment to the 2016 NPRM
A. Provisions Applicable to Both Parts 70 and 71
a. General Comments
b. Scope and Authority
c. Definitions
d. Public Health Prevention Measures To Detect Communicable Disease
e. Apprehension and Detention of Persons With Quarantinable Communicable Diseases
f. Medical Examinations
g. Requirements Relating to Issuance of a Federal Order for Quarantine, Isolation,
or Conditional Release
h. Mandatory Reassessment of a Federal Order for Quarantine, Isolation, or Conditional
Release
i. Medical Review of a Federal Order for Quarantine, Isolation, or Conditional Release
j. Administrative Records Relating to a Federal Order for Quarantine, Isolation, or
Conditional Release
k. Other Due Process Concerns
l. Privacy
m. Payment for Care and Treatment
n. Agreements
o. Penalties
p. Economic Impact
q. Paperwork Reduction Act
B. Provisions Applicable to Part 70 Only (Domestic)
a. General
b. Requirements Relating to Travelers Under a Federal Order of Isolation, Quarantine,
or Conditional Release
c. Report of Death or Illness Onboard Aircraft Operated by an Airline
C. Provisions Applicable to Part 71 Only (Foreign)
a. Requirements Relating to Transmission of Airline and Vessel Passenger, Crew, and
Flight Information for Public Health Purposes
b. Suspension of Entry of Animals, Articles, or Things From Designated Foreign Countries
and Places Into the United States
VI. Alternatives Considered
VII. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
B. The
Regulatory Flexibility Act
C. The Paperwork Reduction Act
D.
National Environmental Policy Act (NEPA)
E. Executive Order 12988: Civil Justice Reform
F. Executive Order 13132: Federalism
G. The Plain Language Act of 2010
HHS/CDC has statutory authority (
42 U.S.C. 264,
265) to promulgate regulations that protect U.S. public health from communicable diseases,
including quarantinable communicable diseases as specified in an Executive Order of
the President.
See Executive Order 13295 (April 4, 2003), as amended by Executive Order 13375 (April
1, 2005) and Executive Order 13674 (July 31, 2014). The need for this rulemaking was
reinforced during HHS/CDC’s response to the largest outbreak of Ebola virus disease
(Ebola) on record, followed by the recent outbreak of Middle East Respiratory Syndrome
(MERS), both quarantinable communicable diseases, and repeated outbreaks and responses
to measles, a non-quarantinable communicable disease of public health concern. This
[*6891] final rule will enhance HHS/CDC’s ability to prevent the introduction, transmission,
and spread of communicable diseases into the United States and interstate by clarifying
and providing greater transparency regarding its response capabilities and practices.
Both the domestic and foreign portions of this regulation include new proposed public
health definitions; new regulatory language implementing HHS/CDC’s activities concerning
non-invasive public health prevention measures (i.e., traveler health screening) at U.S. ports of entry and other U.S. locations (i.e., railway stations, bus terminals); and provisions affording due process to persons
served with a Federal public health order (e.g., isolation, quarantine), including requiring that HHS/CDC explain the reasons for
issuing the order, administrative processes for appealing the order, and a mandatory
reassessment of the order.
The domestic portion of this final rule includes a requirement that commercial passenger
flights report deaths or illnesses to the CDC. It also includes a provision requiring
that individuals apply for a travel permit if they are under a Federal quarantine,
isolation, or conditional release order (unless the specific travel is authorized
by the Federal conditional release order) or if a State or local public health department
requests CDC assistance in enforcing a State or local quarantine or isolation order.
Additionally, the domestic portion of this final rule includes new regulatory language
clarifying when an individual who is moving between U.S. states is “reasonably believed
to be infected” with a quarantinable communicable disease in a “qualifying stage.”
These determinations are made when the CDC considers the need to apprehend or examine
an individual for potential infection with a quarantinable communicable disease. The
foreign portion of this final rule includes new regulatory authority permitting the
CDC Director to prohibit the importation of animals or products that pose a threat
to public health.
HHS/CDC has also changed the text of the regulation to reflect modern terminology,
technology, and plain language used by private industry, public health partners, and
the public. The final rule also authorizes public health monitoring through electronic
or internet-based means of communication for individuals under a Federal conditional
release order who are reasonably believed to be exposed to or infected with a quarantinable
communicable disease. This would include communication through email and webcam application
tools. Finally, while neither modifying nor authorizing additional criminal penalties
for violations of quarantine rules and regulations, this final rule updates regulatory
language to align with existing criminal penalties set forth in statute.
The regulatory impact analysis quantitatively addresses the costs and benefits associated
with this final rule. The economic impact analysis of this final rule is subdivided
into two sections.
The first analysis summarizes the economic impact of changes to
42 CFR 70.1,
42 CFR 71.1/71.4/71.5 for which the primary costs for submitting passenger and crew information
to HHS/CDC are incurred by airlines and vessel operators and the primary benefit is
improved public health responsiveness to assess and offer post-exposure prophylaxis
to travelers potentially exposed to communicable diseases of public health concern.
The most likely estimates of annual costs to airlines, vessel operators, the United
States government, and public health departments are low ($32,622, range $10,959 to
$430,839) because the final rule primarily codifies existing practice or improves
alignment between existing regulatory text and the International Civil Aviation Organization
(ICAO)’s guidelines for symptoms to report. The cost estimates in this final rule
are based on (1) an anticipated small increase in the number of illness reports delivered
by airlines and processed by HHS/CDC and (2) increased costs for airlines and vessel
operators to comply with HHS/CDC orders for traveler and crew contact data, to the
extent that such information is readily available and already maintained, and not
already transmitted to the U.S. Customs and Border Protection (CBP). The cost estimate
also includes an increase in costs for public health departments to contact more exposed
travelers due to the availability of improved contact data.
The best estimate of the annual quantified benefits of the final rule are $110,045
(range $26,337 to $297,393) and mostly result from increased efficiencies for HHS/CDC
and State and local public health departments to conduct contact investigations among
travelers on an aircraft exposed to communicable diseases of public health concern,
especially for measles and tuberculosis. To the extent that improved responsiveness
of airlines to HHS/CDC traveler data orders may result from the implementation of
the provisions in this final rule, HHS/CDC may become better able to respond to infectious
diseases threats and (1) reduce case-loads during infectious disease outbreaks, (2)
reduce public anxiety during disease outbreaks, (3) mitigate economic impacts on businesses
as a consequence of reduced public anxiety associated with quarantinable communicable
disease outbreaks initiated by international travelers (such as have been observed
during outbreak of severe acute respiratory syndrome in Canada or Middle East respiratory
syndrome in South Korea), and (4) reduce the amount of personnel labor time to conduct
large-scale contact investigations in response to a new infectious disease or one
with larger scale public health and medical consequences like Ebola.
The second analysis in this final rule is of a number of provisions that aim to improve
transparency of how HHS/CDC uses its regulatory authorities to protect public health.
HHS/CDC believes that improving the quality of its regulations by providing clearer
explanations of its policies and procedures is an important public benefit. However,
HHS/CDC is not able to attach a dollar value to this added benefit in a significant
way.
On August 15, 2016, HHS/CDC published a notice of proposed rulemaking (NPRM) (
81 FR 54299) to amend
42 CFR part 70 (interstate) and
42 CFR part 71 (foreign) quarantine regulations. The public was invited to comment on these amendments. The
comment period ended October 14, 2016. In the NPRM, HHS/CDC specifically requested
public comment on the following:
• Whether the use of the standard definition of “indigent” is an appropriate threshold
to determine whether an individual cannot afford representation and therefore should
be appointed a medical representative at the government’s expense and whether the
public believes that there may be non-indigent individuals, as defined in the NPRM,
who may have difficulty affording a representative;
• The definition of
public health emergency and its utility in identifying communicable diseases that “would be likely to cause
a public health emergency if transmitted to other individuals” under
42 U.S.C. 264(d)(2)(B);
• Requirements relating to travelers under a Federal order of isolation, quarantine,
or conditional release; specifically, on whether stakeholders [*6892] have concerns regarding the requirement imposed on conveyance operators to not “knowingly”
transport individuals under a Federal order and the feasibility of this requirement
and the application of this provision to individuals under State/local order as well
as individuals traveling entirely within a State.
• Public health prevention measures and whether the public has any concerns regarding
the mandatory health screening of passengers using non-invasive means as defined in
the proposal or the collection of personal information from screened individuals for
the purposes of contact tracing;
• Payment for care and treatment, and whether there are any concerns that all third
party payments be exhausted prior to the Federal reimbursement of medical care or
treatment for individuals placed under a Federal order for quarantine, isolation,
or conditional surveillance;
• The application of requirements relating to issuance of a Federal order for quarantine,
isolation or conditional release as it applies to groups and whether this provision
sufficiently informs the public of the important details concerning circumstances
during which HHS/CDC would issue to groups or individuals Federal orders for quarantine,
isolation, and conditional release and the duration and conditions of such orders;
• Whether 72 hours is the necessary amount of time to conduct a reassessment after
a Federal order is first issued, or if the reassessment should take place earlier
or later;
• Whether or not the public sees a role for the Federal government to ensure that
basic living conditions, amenities, and standards are satisfactory when placing individuals
under Federal orders;
• Whether the definition of “non-invasive” aligns with common perceptions of what
constitutes non-invasive procedures that may be conducted outside of a traditional
clinical setting;
• Whether the penalties proposed, and the circumstances under which such penalties
may be imposed, were clearly explained;
• The applicability of the December 13, 2007 system of records notice (SORN) to the
activities proposed (
72 FR 70867), and whether the SORN sufficiently addresses the public’s concerns related to maintenance
and protection of the data elements proposed;
• The request for a passenger and crew manifest within 24 hours and whether the provision
grants operators of airlines sufficient time for operators to respond to manifests
orders;
• The likelihood that the passenger and crew data elements requested are already collected
and maintained by airline operators for transmission to CDC;
• Any industry concerns regarding whether proposed section 71.63 sufficiently details
the circumstances under which HHS/CDC may impose an embargo on the importation of
animals, articles, or things, including how such an embargo would be implemented,
as well as any concerns regarding coordination with other Federal agencies.
The public comment period for the proposed rule ended on October 14, 2016 and HHS/CDC
received 15,800 comments from individuals, stakeholders, and groups. A summary of
those comments and responses to those comments are found at Section IV, below.
The primary legal authorities supporting this rulemaking are sections 361 and 362
1 of the
Public Health Service Act (
42 U.S.C. 264,
265). HHS/CDC also believes that the following
Public Health Service Act sections are relevant with respect to this rulemaking: section 311 (
42 U.S.C. 243), section 321 (
42 U.S.C. 248), section 322 (
42 U.S.C. 249), section 365 (
42 U.S.C. 268), and sections 367-69 (
42 U.S.C. 270-72). A detailed explanation of these legal authorities was provided in the NPRM published
at
81 FR 54230 (Aug. 15, 2016).
1 Section 3 of Executive Order 13295 (April 4, 2003) states that the functions of the
President under sections 362 and 364(a) of the
Public Health Service Act (
42 U.S.C. 265 and
267(a) are assigned to the HHS Secretary.
On August 15, 2016, HHS/CDC published a Notice of Proposed Rulemaking to update
42 CFR 70 (domestic) and
42 CFR 71 (foreign) quarantine regulations. These amendments were proposed to aid public health responses
to outbreaks of communicable disease, such as the largest outbreak of Ebola virus
disease (Ebola) on record, Middle East Respiratory Syndrome (MERS), both quarantinable
communicable diseases, and repeated outbreaks of measles in the United States, a non-quarantinable
communicable disease of public health concern. (
81 FR 54299). Communicable diseases of public health concern are those diseases that because
of their potential for spread, particularly during travel, may require a public health
intervention. The provisions contained within the proposal were designed to enhance
HHS/CDC’s ability to prevent the further importation and spread of communicable diseases
into the United States and interstate by clarifying HHS/CDC’s response capabilities,
practices, and making them more transparent.
Upon consideration of public comment, the following is a section-by-section summary
of the changes from the proposed text that HHS/CDC made to parts 70 and 71:
Throughout the regulatory text in parts 70 and 71, references to “CDC” or “HHS/CDC”
have been replaced with “Director.” This is in keeping with the common practice that
federal agencies act through employees and officials to whom the authority involved
has been delegated. Director is currently defined in sections 70.1 and 71.1 to mean “the Director, Centers for
Disease Control and Prevention, Department of Health and Human Services, or another
authorized representative as approved by the CDC Director or the Secretary of HHS.”
Where it is necessary to exclude CDC employees or officials from undertaking certain
functions this has been indicated by use of parenthesis, e.g., “Director (excluding the CDC official who issued the quarantine, isolation, or conditional
release order).” This is a stylistic change from the NPRM, but does not result in
a substantive change in the final rule.
• The definition of Agreements has been removed.
• The definition of Electronic or internet-based monitoring has been modified to include “communication through” these means and “audio” conference.
• The definition of Indigent has been modified to increase the threshold to 200% of the applicable poverty guidelines.
• The definition of
Ill person under section 71.1 has been modified to include a person who “Has a fever that has
persisted for more than 48 hours” or “Has acute gastroenteritis, which means either
diarrhea, defined as three or more episodes of loose stools in a 24-hour period or
what is above normal for the individual, or vomiting accompanied by one or more of
the following: One or more episodes of loose stools in a 24-
[*6893] hour period, abdominal cramps, headache, muscle aches, or fever (temperature of 100.4 °F
[38°C] or greater).” This language was quoted verbatim in the preamble of the NPRM
at
81 FR 54305 but was inadvertently omitted from the proposed regulatory text.
• The definition of Medical Examination has been modified to indicate that the health worker conducting the assessment must
be “licensed.”
• The definition of Medical Representative has been changed to Representatives and now includes for an indigent individual the additional appointment of “an attorney
who is knowledgeable of public health practices” if the indigent individual requests
a medical review.
• The definition of Non-invasive has been modified to: (1) Replace “physical examination” with “visual examination;”
(2) specify that the individual performing the assessment must be a “public health
worker (i.e., an individual with education and training in the field of public health)”; and (3)
remove “auscultation, external palpation, external measurement of blood pressure.”
• A definition for Secretary has been added. Secretary means the Secretary of Health and Human Services (HHS) or any other officer or employee
of that Department to whom the authority involved has been delegated. We note that
while the NPRM did not propose this definition, the NPRM referenced the Secretary in defining Public Health Emergency. Thus, HHS/CDC considers it useful to also define the term Secretary.
This provision is has been finalized as proposed, with the exception that references
to CDC have been replaced with Director throughout this section. HHS/CDC has also
added a requirement that the Director arrange for adequate food and water, appropriate
accommodation, appropriate medical treatment, and means of necessary communication,
for individuals who are apprehended or held in quarantine or isolation. Similar language
has been added to an analogous provision at Section 71.33(a).
These provisions are finalized as proposed, with the exception that references to
CDC have been replaced with Director throughout this section. HHS/CDC has also added
a requirement that the Director, as part of the Federal order, advise the individual
that the medical examination shall be conducted by an authorized and licensed health
worker with prior informed consent.
Paragraphs (a)(5) and (a)(4) of these provisions have been modified, respectively,
to require that the Federal order include an explanation that the Federal order will
be reassessed no later than 72 hours after it has been served and an explanation of
the right to request a medical review, present witnesses and testimony at the medical
review, and to be represented at the medical review by either an advocate (e.g., an attorney, family member, or physician) at the individual’s own expense, or, if
indigent, to have representatives appointed at the government’s expense. Paragraph
(b) of these provisions has been modified to require that a Federal public health
order be served within 72 hours of an individual’s apprehension. Paragraph (c) has
been modified to require that the Director arrange for translation or interpretation
services of the Federal order as needed. References to CDC have been replaced with
Director throughout this section.
These provisions have been modified to include paragraph (g) which states that the
Director shall arrange for translation or interpretation services of the Federal order
as needed. References to CDC have been replaced with Director throughout this section.
Paragraph (f) of these provisions has been modified to reference “Representatives,”
consistent with the change in definition. Paragraph (f) of these provisions has also
been modified to remove, “and cannot afford a medical representative” because this
language is duplicative and unnecessary if the individual has already qualified as
indigent. Paragraph (k) of these provisions has been modified to state: “The medical
review shall be conducted by telephone, audio or video conference, or through other
means that the medical reviewer determines in his/her discretion are practicable for
allowing the individual under quarantine, isolation, or conditional release to participate
in the medical review.” These provisions have also been modified to include paragraph
(q) which states that the Director shall arrange for translation or interpretation
services as needed for purposes of this section. References to CDC have been replaced
with Director throughout this section.
These sections have been modified to remove paragraphs (5) regarding agreements between
CDC and the individual.
These provisions have been finalized as proposed, with the exception that references
to CDC have been replaced with Director throughout this section.
These provisions have been removed.
The content of these provisions has been finalized as proposed. Proposed § 70.19 Penalties has been moved to § 70.18, since proposed § 70.18 Agreements has been removed from this final rule.
Paragraph (b) has been modified to include “known or possible exposure” information
to the list of information that may be collected. References to CDC have been replaced
with Director throughout this section.
Paragraph (a), (a)(4), (b)(1), (b)(2), and (c) of this provision have been modified
to remove “agreements.” Paragraph (d) has been modified to add “to individuals traveling
entirely intrastate and to conveyances that may transport such individuals.” The language
in paragraph (d) was discussed in the NPRM at
81 FR 54243 and public comment concerning intrastate application of this provision was explicitly
solicited. The language, however, was inadvertently omitted from the regulatory text.
References to CDC have also been replaced with Director throughout this section. In
response to public comments, HHS/CDC
[*6894] has included a requirement that the Director respond to a request for a travel permit
within five (5) business days and to an appeal under this section within three (3)
business days. Public comments concerning this provision are addressed below.
This provision has been finalized as proposed, with the exception that references
to CDC have been replaced with Director throughout this section.
These provisions have been finalized as proposed, with the exception that the title
has been modified to remove references to collection and storage of information to
more accurately reflect the requirements under this section and references to CDC
have been replaced with Director throughout this section.
This provision has been finalized as proposed with the exception that references to
CDC have been replaced with Director throughout this section.
The title of this provision has been finalized as proposed, to remove the word “Radio.”
On August 15, 2016 HHS/CDC published a Notice of Proposed Rulemaking proposing to
amend the current interstate (domestic) and foreign quarantine regulations for the
control of communicable diseases. The NPRM included a 60-day public comment period
and during this time, HHS/CDC received 15,800 comments from individuals, groups, organizations,
industry, and unions. Comments were both in support of and in opposition to the regulation.
Many public comments expressed concern that these updated regulations sought to compel
medical treatment or vaccination without patient consent. One association stated its
strong objection “to the coercive imposition of treatment, including vaccination,
without the genuine consent of the patient.”
HHS/CDC begins this section by stating that these regulations do not compel vaccination
or involuntary medical treatment. In keeping with current practice, HHS/CDC will continue
to recommend care and treatment, including post-exposure prophylaxis when indicated,
to individuals who are either sick with or at risk of disease following exposure to
a communicable disease of public health concern.
HHS/CDC also received comments relating to immigration policy and regulations, issues
of citizenship, border security, religion, personal testimony regarding adverse vaccine
events, and requests to apply these regulations only to individuals who are not citizens
of the United States. These comments are beyond the scope of this final rule and have
not been included in this discussion. However, HHS/CDC notes that it will continue
to apply communicable disease control and prevention measures uniformly to all individuals
in the United States, regardless of citizenship, religion, race, or country of residency.
HHS/CDC also received public comment regarding disinsection (
i.e., measures to control or kill insect vectors of disease) and fumigation procedures,
citing HHS/CDC’s statutory authorities relating to inspection, fumigation, and pest
extermination. We note that while HHS/CDC maintains regulations at
42 CFR 70.2 and
71.32(b) implementing this statutory authority, such comments are outside of the scope of
this final rule, which did not include proposed changes to these regulatory provisions.
The following is a discussion of public comments received that are applicable and
within the scope of the regulation. Topics including: Accountability, Administrative
Records, Agreements, Apprehension, Authority (including Scope), Conditional Release,
Constitutional Issues (including Amendments, Court Cases, and Habeas Corpus), Data
Collection, Definitions, Detention, Due Process, Economic Impact, Electronic Monitoring,
Exposure, Informed Consent, Least Restrictive Means, Minors, Medical Assessments,
Examination, Notice, Penalties, Privacy, Qualifying Stage, Quarantine, Quarantinable
Communicable Diseases List, and others are discussed.
A summary of comments and a response to those comments are found below, organized
by general and specific comments that apply to both parts 70 and 71, comments that
only apply to part 70 (interstate), and comments that only apply to part 71 (foreign).
Since posting the proposed regulation on August 15, 2016, HHS/CDC received 15,800
public comments. HHS/CDC received several comments from individuals, groups, or industry
requesting to extend the 60-day comment period. In light of the number of comments
submitted, HHS/CDC has determined that a 60-day comment period was both fair and sufficient
to adequately inform the public of the contents of this rulemaking, allow the public
to carefully consider the rulemaking, and receive informed public feedback. Thus,
HHS/CDC declines to reopen the comment period.
Several commenters requested that HHS/CDC withdraw the NPRM in its entirety. A non-profit
organization stated that the “NPRM would be, if adopted, a direct and onerous infringement
of the personal liberties of Americans and an unnecessary aggressive method of assisting
in the control of communicable disease.” Another commenter said that the “NPRM is
premature.” HHS/CDC disagrees and declines to withdraw the proposal in its entirety
because it contains important measures that will aid the public health response to
prevent the introduction, transmission, and spread of communicable diseases into and
within the United States. Moreover, in the spirit of transparency, these measures,
which are largely current practice, are being published and codified to make the public
aware of their use.
HHS/CDC received a comment from a partnership of public health legal scholars and
organizations stating that it should promulgate a separate rule guaranteeing humane
conditions of confinement. HHS/CDC disagrees that such a separate rule is needed and
believes that the current final rule adequately addresses these concerns, as discussed
in detail below.
HHS/CDC received a comment that the proposed rule does not comply with Executive Order
12866 because there is no public need for the rule and it did not adequately assess
the costs and benefits of the rule, including the alternative of not regulating. HHS/CDC
disagrees. As discussed in detail below, this rule describes the public health measures
that may be used in response to outbreaks of communicable diseases, such as the recent
largest recorded outbreak of Ebola. The economic impact analysis has been clarified
to more clearly differentiate quarantinable and non-quarantinable diseases. The [*6895] economic impact analysis also examines the costs and benefits of the Final Rule measured
against current practices (i.e., a status quo baseline). Both the costs and benefits of this Final Rule are small
because the provisions set forth are primarily a codification of current practices,
based on existing regulatory authorities.
A public health research center commented that there is no evidence that measures
employed at points of entry were effective during the response to the 2014-2016 Ebola
outbreak and that HHS/CDC is attempting to codify these ineffective practices for
use in future disease outbreaks. They further noted that despite greater than 99%
complete monitoring, zero cases of Ebola were detected among those monitored. HHS/CDC
appreciates this comment and recognizes the challenges presented by measuring the
benefits of prevention in public health.
HHS/CDC disagrees that the measures employed in response to the 2014-16 Ebola outbreak
were ineffective and that it is seeking to codify ineffective measures. HHS/CDC considers
more than 99% complete monitoring a successful effort in State and Federal cooperation
in response to an unprecedented outbreak of Ebola. Second, rather than the number
of cases detected, HHS/CDC considers the key metrics of effectiveness to be the number
of people who were able to continue to travel safely without fear of disease spread
and the ability to facilitate rapid isolation and evaluation of the approximately
1400 individuals who developed illness compatible with Ebola during the 21-day monitoring
period. Finally, we note that this commenter limited his or her statement to HHS/CDC
measures put into place at U.S. ports of entry during the Ebola response.
The enhanced public health risk assessment protocol put into place at U.S. ports of
entry in response to the Ebola outbreak was one part of a layered risk mitigation
program to prevent the importation and spread of Ebola within the United States, which
included exit screening in the affected countries as recommended by the World Health
Organization (WHO) (see Statement on the 1st meeting of the International Health Regulations
[IHR] Emergency Committee on the 2014 Ebola outbreak in West Africa 8/8/2014) and
a reliance on air industry partners for detection and reporting of potentially ill
travelers prior to arrival.
The enhanced entry risk assessment process was instituted after an individual infected
with Ebola entered the United States and transmitted the disease. This case demonstrated
that the processes then in place to prevent departure of individuals exposed to or
infected with Ebola in affected West African countries could not detect persons who
were exposed but were unaware of or denied such exposure and were potentially incubating
the infection. To further reduce the risk of introduction and spread, HHS/CDC recommended
monitoring of all potentially exposed individuals by a public health authority through
the 21-day risk period after potential exposure, rather than relying on previously
recommended self-monitoring. Monitoring was viewed as the least restrictive alternative
to widespread quarantine and travel bans demanded by some members of the public that
would ultimately have hampered the response efforts in West Africa and domestically.
HHS/CDC, along with its Federal and State partners, implemented an entry process by
which individuals identified as having recently traveled to, from, or through an affected
country entered through five ports of entry where public health staff and partners
were stationed, submitted accurate and complete contact information, were checked
for symptoms, and were provided answers to Ebola risk assessment questions.
This was done for several reasons:
• To ensure that any individual entering the United States who could have been exposed
to or infected with Ebola in a country experiencing an Ebola outbreak was identified
and reported to the State and local health department of final destination so that,
if the individual became ill, State or local health departments could rapidly notify
healthcare providers prior to the individual’s arriving at a hospital. This process
was designed specifically to prevent unknowing individuals from exposing others such
as occurred in Texas when a patient exposed two healthcare workers.
• While HHS/CDC acknowledges that a public health worker may be unlikely to encounter
someone with symptoms at the moment of entry because of the 21-day incubation period,
individuals coming from the outbreak countries frequently traveled for well over 24
hours and in many cases had itineraries that involved interstate movement within the
United States. The odds of developing symptoms during that travel, and potential onward
travel, were considered non-trivial, and public health measures to detect symptoms
upon entry were considered warranted given the serious morbidity and costs associated
with Ebola.
• The risk assessment at the limited ports of entry provided an important opportunity
for HHS/CDC to stratify the risk of developing Ebola for every individual who entered
from the affected countries. It allowed HHS/CDC to work with State and local health
departments in implementing the least restrictive means of monitoring individuals
for development of symptoms. HHS/CDC notes that there were no Federal quarantine orders
issued because of the availability of monitoring options provided by State and local
authorities under the Interim U.S. Guidance for Monitoring and Movement of Persons with Potential Ebola
Virus Exposure.
• The encounter also provided an opportunity to provide travelers with educational
materials, orientate them to the monitoring program (Check and Report Ebola (CARE)),
and facilitate reporting of the traveler’s health status to State and local health
departments.
The enhanced entry risk assessment and monitoring process described above was developed
in response to the epidemiological profile of Ebola and the complexities of a 21-day
incubation period. However, in the event of an outbreak of a different communicable
disease requiring enhanced assessment or monitoring of travelers (whether quarantinable
or non-quarantinable), HHS/CDC, in concert with Federal and State partners, may implement
a different system of risk assessment and monitoring. HHS/CDC would tailor the program
in accordance with the scientific evidence of the situation and the utility and feasibility
of the program given the availability of resources.
The same public health research center commented that employing non-evidence-based
measures is contrary to the United States’ international legal agreements, specifically
mentioning the public health measures implemented during the response to Ebola as
they pertain to the International Health Regulations (IHR 2005). The commenter further
stated that given the absence of evidence to support the use of travel monitoring
and quarantine, HHS/CDC should proceed cautiously before employing these measures
in the future.
Having addressed the commenter’s concern regarding the evidence of the effectiveness
of public health measures at ports of entry above, HHS/CDC concurs with the commenter
that the use of quarantine and travel restrictions, in the absence of evidence of
their utility, is detrimental to efforts to combat the spread of communicable disease.
However, HHS/CDC disagrees that it used non-evidence based measures in contravention
of the IHR. [*6896] To the contrary, HHS/CDC used the best available science and risk assessment procedures
in designing a port of entry risk assessment and management program that took into
account available resources, circumstances in the countries with Ebola outbreaks,
and principles of least restrictive means to successfully ensure that measures to
ban travel between the United States and the affected countries were unnecessary.
These measures would have negatively impacted the efforts to combat Ebola in the region
and would have had dramatic negative implications for travelers and industry.
Furthermore, the measures did not unduly affect travel or trade beyond the voluntary
changes made by industry and travelers. HHS/CDC believes that CDC’s entry risk assessment
and management program was appropriate, commensurate with the risk, and consistent
with the following WHO recommendation: “[Member] States should be prepared to detect,
investigate, and manage Ebola cases; this should include assured access to a qualified
diagnostic laboratory for Ebola and, where appropriate, the capacity to manage travelers
originating from known Ebola-infected areas who arrive at international airports or
major land crossing points with unexplained febrile illness.” WHO Statement on the 1st meeting of the IHR Emergency Committee on the 2014 Ebola
outbreak in West Africa (Aug. 8, 2014). Travelers were assessed for risk on an individual basis upon entry;
and any individual who met the pre-defined symptom threshold (based on exposure level)
was medically evaluated and referred to care as needed. No Federal quarantine orders
were issued for the duration of the response because HHS/CDC in coordination with
State and local public health authorities was able to tailor its interventions to
allow onward travel.
Future outbreaks may necessitate a different combination of public health measures
at ports of entry. In those circumstances, HHS/CDC will use the best available science
to assess the risk of importation and spread within the United States.
One commenter suggested that if HHS/CDC were to apply the “Precautionary Principle,”
it would not promulgate these regulations. HHS/CDC notes first that the “precautionary
principle,” often described as the avoidance of harm when there is scientific uncertainty
about risks, originated in environmental contexts and remains largely associated with
environmental issues. Invoking the precautionary principle in an environmental context,
for instance, places the onus on those considering a potentially harmful action, such
as drilling or mining near a watershed, to prove its safety in advance. The principle
may be used by policy makers to justify discretionary decisions in situations where
there is the possibility of harm from making a certain decision (e.g. taking a particular course of action) when extensive scientific knowledge on the
matter is lacking.
HHS/CDC disagrees that this regulation will have harmful effect or that these measures
lack a scientific basis for protecting public health. In fact, as described above
regarding the response efforts to the 2014-2016 Ebola response, HHS/CDC has successfully
employed the measures outlined in this regulation for many years. Again, the provisions
outlined through this regulation are not new practices, nor new authorities, but a
codification of HHS/CDC practice to protect public health.
One commenter suggested that education on healthy practices would be more effective
than regulatory provisions. Another commenter stated that our immune systems would
ward off communicable disease if we encourage clean water, adequate shelter, effective
sewage treatment, and nutritious food. HHS/CDC agrees that these necessities are important
to public health, and we rely on health communication often to educate the public
on how to protect themselves and others from certain communicable diseases. For example,
HHS/CDC routinely advises people with seasonal influenza to stay home from work and
school, to cover their coughs and sneezes, and to wash their hands. HHS/CDC also works
with State, local, and airport authorities in posting health education materials for
the public. However, in certain circumstances, when a communicable disease poses a
severe health threat to others, additional measures may be needed to protect the public’s
health. This is particularly important in situations when the infectious individual
has disregarded public health recommendations by, for example, refusing to take prescribed
medications to treat infectious tuberculosis or traveling while infectious. In such
situations, it may be necessary to use public health authorities to require the individual
to remain in isolation or to prevent travel to protect the public’s health.
HHS/CDC received a few comments suggesting that publication of the NPRM in the
Federal Register was not sufficient to inform the public of these proposed updates. One comment questioned
why the proposed regulations were not more widely disseminated through media outlets.
In response, HHS/CDC notes that Federal courts have long recognized that publication
in the
Federal Register is legally sufficient for giving affected persons notice of proposed rulemaking.
See Federal Crop Ins. Corp. v.
Merrill, 332 U.S. 380, 385 (1947) (“Congress has provided that the appearance of rules and
regulations in the
Federal Register gives legal notice of their contents.”). The
Federal Register, within the National Archives and Records Administration, is the official publication
for all Federal agency rules, proposed rules, and notices of Federal agencies and
organizations, as well as for Executive Orders and certain other presidential documents.
Individuals interested in obtaining more information regarding HHS/CDC’s regulatory
processes, including input provided by persons and organizations, may examine the
regulatory docket or submit a request through the
Freedom of Information Act.
HHS/CDC received a comment stating that HHS/CDC should, by regulation, provide sufficient
public health justification for screening practices to support its proposed public
health prevention measures at ports of entry. While HHS/CDC agrees that it should
provide sufficient public health justification for large-scale screening practices,
HHS/CDC disagrees that this justification should be formalized in regulations. During
the 2014-2016 Ebola epidemic, HHS/CDC issued Interim U.S. Guidance for Monitoring and Movement of Persons with Potential Ebola
Virus Exposure to assist HHS/CDC staff and public health partners engaged in the response. The guidance
provided public health authorities and partners with recommendations for monitoring
people potentially exposed to Ebola and for evaluating their intended travel, including
the application of movement restrictions when necessary. From August 2014-December
2015, the guidance was accessed online approximately 334,000 times, with more than
88,000 views during the first 4 days after the October 2014 update that added recommendations
for active monitoring and clarified travel and movement restriction recommendations.
Updates to the guidance to accommodate new information and changes in the outbreak
situation continued through 2015. The guidance was retired on February 19, 2016, when
more than 45 days had passed since Guinea was declared free of Ebola virus transmission,
signaling widespread human-to-human transmission in the [*6897] affected countries was at an end. Formalizing this guidance in regulation would have
deprived HHS/CDC of the needed flexibility to respond to public health events as they
occurred, would have proved administratively burdensome and unnecessary, and would
have potentially delayed prevention measures therefore resulting in a less effective
response. HHS/CDC will consider the need for similar guidance during future outbreaks
taking into account the extent of the outbreak and the risk of importation and spread
of disease into the United States.
HHS/CDC received several comments suggesting that the proposed regulations were not
written in plain language and were therefore difficult to understand. One commenter
also noted errors in the document such as hyperlinks, references, and footnotes. This
commenter also reviewed the NPRM for inconsistencies, conflicts, missing definitions,
misleading language, and ambiguities. HHS/CDC thanks these commenters for the input.
We have developed communication materials and published them to our Web site to help
facilitate the review and comprehension of these documents. Interested persons should
see
http://www.cdc.gov/quarantine/notice-proposed-rulemaking-control-communicable-diseases.html.
One commenter opposed the rule because of a perceived negative social impact upon
individuals placed under a public health order. We respond that one compelling reason
for the publication of this final rule is to make the public aware of these measures
so that the words, purposes, and meanings of “quarantine” and “isolation” become more
familiar and less likely to cause public anxiety and stigmatization.
HHS/CDC received comments suggesting that, to best prevent the introduction of communicable
diseases into the U.S., individuals who travel to or originate in countries with high
risk of communicable disease should not be allowed to enter (or return to) the United
States. On March 27, 2015, HHS/CDC published a Notice in the
Federal Register titled
Criteria for Recommending Federal Travel Restrictions for Public Health Purposes,
Including for Viral Hemorrhagic Fevers. See 80 FR 16400 (Mar. 27, 2015). The Notice describes the tools the Federal government has to ensure
that people who pose a public health risk do not board flights or enter the United
States without a public health evaluation.
See 80 FR 16400 (Mar. 27, 2015). It is the policy of HHS/CDC to work with the Department of State,
and any other relevant Federal and State agencies to ensure infected U.S. citizens
seeking to return to the U.S. do so in a manner that does not place the public at
risk.
A few commenters expressed concern, as parents or guardians, about their rights with
respect to children or minors. Specifically, these commenters wondered whether children/minors
would be separated from parents/guardians during a public health risk assessment.
HHS/CDC thanks the commenters for these questions and appreciates the opportunity
to respond. In response, HHS/CDC notes that these regulations do not limit the rights
that parents or guardians may have over minor children, including the right to make
medical decisions. Notwithstanding, children are included in the definition of “individuals”
as used in these regulations and thus minor children may be subject to apprehension,
detention, examination, and conditional release for quarantinable communicable diseases
to the same extent as adults. In such rare circumstances, HHS/CDC will work with the
child’s parent or guardian to ensure that the rights accorded to any individual subject
to Federal isolation or quarantine, such as the opportunity for an administrative
medical review, are adequately protected.
In addition, and in keeping with standard public health practice, parents or guardians
while in the presence of infected minor children may be required to adhere to infection
control precautions for their own protection. Such protections may include wearing
personal protective equipment (such as a mask) while in close proximity to the child/minor
to avoid further transmission of the illness. In extremely rare circumstances, such
as a child infected with Ebola, the risk may be too great to allow a parent to remain
with a child; however, every effort will be made to facilitate communication between
a parent and a minor child through the least restrictive means, for example, through
the use of technology.
One commenter asked about HHS/CDC obtaining the consent of a parent or legal guardian
prior to the medical examination, quarantine, or treatment of minors. We respond that
HHS/CDC will adhere to all applicable laws regarding the medical examination or treatment
of minors. If minors are traveling unaccompanied by a parent or legal guardian and
are believed to be infected with or exposed to a quarantinable communicable disease,
HHS/CDC will use its best efforts to contact a parent or guardian to obtain consent
prior to medical examination. In addition, HHS/CDC will not restrict a minor’s ability
to communicate with family or legal counsel hired by the minor’s parent or legal guardian.
As explained further below, HHS/CDC will appoint representatives, including a medical
representative and an attorney, if the individual (including a minor’s parent or legal
guardian) is indigent and requests a medical review. HHS/CDC clarifies, however, that
the public health measures included in this final rule, including apprehension, examination,
quarantine, and isolation, do not require a parent or legal guardian’s consent as
a prerequisite to their application. However, in response to concerns about informed
consent, HHS/CDC has added regulatory language requiring that the Director advise
the individual that if a medical examination is required as part of a Federal order
that the examination will be conducted by an authorized and licensed health worker
with prior informed consent.
HHS/CDC received comments from the public questioning whether HHS/CDC is a part of
the Federal government and has the authority to propose and promulgate regulations,
or whether the Agency is a private entity. The “Communicable Disease Center” became
part of the U.S. Public Health Service on July 1, 1946 and is an Agency within the
U.S. Department of Health and Human Services. For more information on the history
of CDC, please see
http://www.cdc.gov/museum/timeline/index.html.
HHS/CDC received numerous comments from the public seeking clarity on the scope of
authority the Agency has to take actions described in this regulation. Specifically,
HHS/CDC received comments questioning whether the authority to detain an individual
may be exercised by a Federal agency of government, instead of the U.S. President
or Congress. Several commenters specifically questioned whether the wording of the
regulation was too “general” and expressed concern over its potential for abuse. A
public health organization recommended that HHS/CDC’s authority should be limited
only to those diseases listed by Executive Order as quarantinable communicable diseases.
An association suggested that the proposed rule would vastly increase the authority
of HHS/CDC. One individual stated that this regulation is an attempt by HHS/CDC to
evade Congress. One organization speculated that HHS/CDC plans to request that the
list of quarantinable communicable diseases be expanded “to include measles and other
vaccine targeted diseases for the purpose of [*6898] apprehending and quarantining travelers entering the US or traveling between States,
who have not been vaccinated with MMR (measles-mumps-rubella vaccine) and other Federally
recommended vaccines.”
In response, HHS/CDC first notes that it cannot—and will not—act beyond the scope
of authority granted by Congress in statute; HHS/CDC offers the following clarifications.
Under section 361(a) of the
Public Health Service Act (
42 U.S.C. 264(a)), the HHS Secretary is authorized to make and enforce regulations as in the Secretary’s
judgment are necessary to prevent the introduction, transmission, or spread of all
communicable diseases from foreign countries into the States or possessions of the
United States and from one State or possession into any other State or possession.
Under section 361(b)(
42 U.S.C. 264(b)), the authority to issue regulations authorizing the apprehension, examination, detention,
and conditional release of individuals is limited to those communicable diseases specified
in an Executive Order of the President,
i.e., “quarantinable communicable diseases.” The authority for carrying out these regulations
has been delegated from the HHS Secretary to the CDC Director, who in turn delegated
these authorities to HHS/CDC’s Division of Global Migration & Quarantine (DGMQ). These
quarantinable communicable diseases are currently limited to cholera, diphtheria,
infectious tuberculosis (TB), plague, smallpox, yellow fever, and viral hemorrhagic
fevers (such as Marburg, Ebola, Lassa fever, and Crimean-Congo), severe acute respiratory
syndromes, and influenza caused by novel or re-emergent influenza viruses that are
causing or have the potential to cause a pandemic.
See Executive Order 13295 (April 4, 2003), as amended by Executive Order 13375 (April
1, 2005) and Executive Order 13674 (July 31, 2014). Changes to the list of quarantinable
communicable diseases are beyond the scope of this regulation. And again, we reemphasize
that HHS/CDC does not intend, through these regulations, to mandate vaccination or
compulsory medical treatment of individuals.
One commenter supported the international proposals (part 71), but urged HHS/CDC to
remove the domestic portion (part 70) of this regulation. We disagree. HHS/CDC’s authorities
apply to all travelers in the United States, regardless of citizenship or residency,
and are intended to complement State authorities within their jurisdictions by providing
a mechanism to prevent importation of communicable disease from other countries as
well as spread of communicable disease between States and between States and territories.
Thus, HHS/CDC’s and States’ authorities together create a comprehensive system to
protect the public from communicable disease threats including in situations such
as interstate travel when a single State’s authorities may be inadequate to address
the communicable disease threat.
Several commenters suggested that HHS/CDC has the authority to unilaterally change
or update the list of quarantinable communicable diseases. Other commenters requested
that the list be narrowed to only those diseases with a “high mortality rate.” HHS/CDC
reemphasizes that, as prescribed by statute, the list of quarantinable communicable
diseases may only be changed by Executive Order of the President and that such suggestions
are beyond the scope of this final rule.
HHS/CDC received several comments on the Agency’s accountability system, encouraging
that a “strong system of checks and balances” should be in place for this regulation
to be implemented. HHS/CDC agrees that there should be accountability and oversight
regarding the agency’s activities. We note that these regulations do not affect the
ability of Congress to conduct its oversight activities or affect the jurisdiction
of federal courts to review federal agency actions under the
Administrative Procedure Act (
5 U.S.C. 704).
HHS/CDC received a comment that there is no court supervision of HHS/CDC activities.
We disagree. These regulations do not affect the jurisdiction of the Federal courts
or the statutory rights of individuals to obtain judicial review of CDC’s actions
and decisions through appropriate mechanisms such as the habeas corpus statute (
28 U.S.C. 2241) or the
Administrative Procedure Act (
5 U.S.C. 704).
Some commenters questioned the need for HHS/CDC to use its authorities if the threat
of death is minimal compared with the size of the population, listing illnesses such
as chickenpox, pertussis, Zika, the common cold and flu, and leprosy. One organization
suggested that, through the language of the NPRM, HHS/CDC was “equating” non-quarantinable
diseases with quarantinable diseases. Another commenter suggested that HHS/CDC’s authority
to act should be based on the mortality of the illness, rather than whether or not
it appears on the list of quarantinable communicable diseases. HHS/CDC thanks the
commenters for consideration of the proposal as well as the input provided.
First, we note that HHS/CDC only has authority to quarantine or isolate individuals
who have illnesses that are listed by Executive Order of the President as quarantinable
communicable diseases. HHS/CDC does not have the ability or authority to unilaterally
modify the list of quarantinable communicable diseases. Second, because HHS/CDC also
has statutory authority to prevent the “introduction, transmission, and spread” of
communicable diseases, HHS/CDC may take actions other than quarantine or isolation
to protect the public’s health. These other actions may include contact tracing investigations
to notify individuals to seek proper treatment if they have been exposed to a communicable
disease, even if the disease is not listed by Executive Order as quarantinable. HHS/CDC
does not seek to compel vaccination or medical treatment. In keeping with current
practice, HHS/CDC recommends certain vaccines for post-exposure prophylaxis and individuals
may choose to follow these recommendations as they deem appropriate.
Other commenters questioned why diseases such as Ebola, measles, and Zika—three very
different diseases with three very different effects on individuals—are used to support
the same regulatory provisions. One organization quoted the NPRM, citing correctly
that while measles is not a quarantinable communicable disease, it was used in the
NPRM to support the need for this updated regulation. HHS/CDC welcomes the opportunity
to provide further clarification.
The proposed rule provides HHS/CDC with a number of options for public health interventions
based on a public health risk assessment of the communicable disease in question and
the situation at hand. These interventions could include conducting a contact investigation
on an airplane or vessel if a person with a serious communicable disease was known
to have traveled on the airplane or vessel. These contact investigations are similar
to those conducted by health departments in community settings. In addition to these
interventions, for the nine communicable diseases currently designated by Executive
Order as quarantinable communicable diseases, HHS/CDC may apprehend, detain, examine,
quarantine, isolate, or conditionally release individuals for purposes of preventing
communicable disease spread. Ebola and infectious tuberculosis are examples of quarantinable
communicable diseases.
[*6899]
HHS/CDC also provides the public with recommendations to address other communicable
diseases of public health concern. Zika is a good example of a disease of public health
concern because of the ways it can be spread, e.g., through mosquitoes, sexual transmission, and maternal-fetal transmission. Therefore,
HHS/CDC has recommended avoiding mosquito bites, protecting against sexual transmission,
and for pregnant women to avoid travel to areas where Zika is spreading. Another example
is seasonal influenza, which is very contagious but also very common; therefore, HHS/CDC
makes recommendations for people sick with flu-like symptoms to stay home from work
or school and take basic precautions such as covering their coughs and sneezes and
washing their hands. In all situations, HHS/CDC considers how common and severe the
communicable disease is, how it is transmitted, and what interventions are available
and appropriate before making recommendations or taking action to protect the health
of the public.
One commenter questioned why HHS/CDC was not able to currently control all communicable
diseases, specifically leprosy. While HHS/CDC works regularly and continuously with
other Federal, State, local and tribal health departments to eliminate the introduction,
transmission and spread of all communicable disease, outbreaks can and do still occur.
HHS/CDC staff have experienced first-hand the impact of globalization on public health.
The rapid speed and tremendous volume of international and transcontinental travel,
commerce, and human migration enable microbial threats to disperse worldwide in 24
hours—less time than the incubation period of most communicable diseases. These and
other forces intrinsic to modern technology and ways of life favor the emergence of
new communicable diseases and the reemergence or increased transmission of known communicable
diseases.
HHS/CDC received many comments regarding measles and the need to apply public health
measures to prevent the transmission and spread of the disease. We note also that
while measles may be transmissible during travel, it is not one of the quarantinable
communicable diseases listed by Executive Order of the President. Therefore, while
HHS/CDC may recommend post-exposure prophylaxis, or other ways to manage and prevent
spread, we do not have the authority to apprehend, examine, detain, or conditionally
release individuals who may have measles, nor those who may have been exposed.
See 80 FR 16,400 (Mar. 27, 2015)(describing air travel restrictions that may be applicable to
a passenger who would represent a threat to public health).
HHS/CDC believes that requesting that DHS restrict the air travel of persons with
measles is warranted because measles is a serious and highly contagious communicable
disease that would pose a public health threat during travel. People exposed to measles
who are not immune to the infection and have not been vaccinated following the exposure
are advised to delay their travel voluntarily until they are no longer at risk of
becoming infectious.
A number of commenters suggested that the proposed regulations are unconstitutional
or in violation of the “Nuremberg Code,” the United Nations Educational, Scientific
and Cultural Organization (UNESCO), the Universal Declaration on Bioethics and Human
Rights, the Geneva Convention, human rights in general, and/or civil liberties in
general because they ostensibly authorize compulsory medical treatment without informed
consent. Commenters also cited numerous Supreme Court cases purportedly in support
of these claims, such as Mills v. Rogers, 457 U.S. 291 (1982), (curtailing the involuntary administration of anti-psychotic
drugs to mental patients); Vacco v. Quill, 521 U.S. 793 (1997) (constitutionality of an assisted suicide ban); Washington v. Harper, 494 U.S. 210 (1990) (involuntary administration of anti-psychotic drugs to prison
inmates); Sell v. United States, 539 U.S. 166 (2003)(upholding certain strict due process protections before any involuntary
administration of anti-psychotic drugs to incarcerated prisoners can be made); and
Canterbury v. Spence, 409 U.S. 1064 (1972)(duty of doctors to obtain informed consent). HHS/CDC disagrees
and re-asserts that this final rule does not authorize compulsory medical treatment,
including compulsory vaccination, without informed consent.
These regulations do not violate or take away any recognized rights guaranteed by
the U.S. Constitution or applicable international agreements. While HHS/CDC has successfully
responded to outbreaks of communicable diseases, such as Ebola, these regulations
will improve HHS/CDC’s future ability to prevent the introduction, transmission, and
spread of communicable diseases, through such mechanisms as improved reporting of
illnesses and public health prevention measures at airports. While many of these activities
have been carried out in the past through internal operating procedures, these regulations
improve the public’s awareness and understanding of HHS/CDC’s activities to protect
the public’s health.
One commenter expressed concerns about religious exemptions for mandatory vaccination
or treatment. In response, HHS/CDC notes that these regulations do not authorize compulsory
vaccinations or medical treatment. While HHS/CDC will implement these regulations
in a manner consistent with respecting the religious rights of individuals, religion
is not a basis for exempting individuals from the provisions of these regulations,
including those provisions relating to quarantine and isolation.
One commenter raised similar concerns that the regulations may lead to apprehensions
based on factors unrelated to public health such as wearing of religious garb or reading
of certain newspapers. HHS/CDC agrees that public health actions should not be taken
based on factors unrelated to protecting the public’s health and these regulations
do not authorize such actions. Additionally, these regulations strike the appropriate
balance between individual liberties and public health protection.
Several commenters questioned whether quarantine and isolation may be carried out
consistent with the Fourth Amendment to the U.S. Constitution. One commenter also
suggested that implementation of public health prevention measures at airports would
lead to “unreasonable searches and seizures” under the Fourth Amendment. HHS/CDC disagrees
with these assertions. The Fourth Amendment protects the rights of persons to be free
in their persons, houses, papers, and effects, against unreasonable government searches
and seizures. HHS/CDC notes that at ports of entry, routine apprehensions and examinations
related to quarantine and isolation may fall under the border-search doctrine, which
provides that, in general, searches conducted by CBP officers at the border are not
subject to the requirements of first establishing probable cause or obtaining a warrant.
See United States v.
Roberts, 274 F.3d 1007, 1011 (5th Cir. 2001);
see also United States v.
Bravo, 295 F.3d 1002, 1006 (9th Cir. 2002) (noting that only in circumstances involving
extended detentions or intrusive medical examinations have courts required that border
searches be premised upon reasonable suspicion). Similarly, apprehensions and examination
of persons traveling interstate under this rule are authorized under the special-needs
doctrine articulated by the
[*6900] Supreme Court in
Skinner v.
Railway Labor Executives’ Ass’n, 489 U.S. 602 (1989) because of the “special need” in preventing communicable disease
spread. Furthermore, to the extent that “probable cause,” rather than “special needs,”
would be the applicable Fourth Amendment standard, HHS/CDC contends that meeting the
requirements of
42 U.S.C. 264 satisfies this standard.
See Villanova v.
Abrams, 972 F.2d 792, 795 (7th Cir.1992)(noting that probable cause for emergency civil commitment
exists where “there are reasonable grounds for believing that the person seized is
subject to the governing legal standard.”). HHS/CDC further acknowledges that any
searches and seizures of individuals must be reasonable under the circumstances. HHS/CDC
reiterates that this final rule does not authorize compulsory medical treatment, including
vaccination, without informed consent.
HHS/CDC received a comment citing Missouri v. McNeely, where the U.S. Supreme Court ruled that police must generally obtain a warrant before
subjecting a drunken-driving suspect to a blood test, and that the natural metabolism
of blood alcohol does not establish a per se exigency that would justify a blood draw without consent. In response, HHS/CDC notes
that courts have recognized that while the requirements for probable cause and a warrant
generally apply in a criminal context, these standards do not apply when the government
is conducting a non-law enforcement related activity. See Nat’l Treasury Employees Union v. Von Raab, 489 U.S. 665 (1989) (reaffirming the general principle that a government search may
be conducted without probable cause and a warrant when there is a special governmental
need, beyond the normal need for law enforcement). HHS/CDC reiterates that the special-needs
doctrine articulated by the Supreme Court in Skinner v. Railway Labor Executives’ Ass’n., 489 U.S. 602 (1989) provides the appropriate legal standard under the Fourth Amendment
for apprehensions and detentions under this final rule.
Several commenters also questioned whether the regulations are consistent with the
requirements of the Fifth and Sixth Amendments to the U.S. Constitution. We note at
the outset that the Sixth Amendment only applies to criminal proceedings and thus
would be inapplicable to isolation and quarantine decisions which are public health
protection measures unrelated to the normal needs of law enforcement. Furthermore,
HHS/CDC asserts that this final rule is consistent with the requirements of due process
embodied in the Fifth Amendment to the U.S. Constitution. Specifically, procedural
safeguards contained in the final rule include: (1) A requirement for written orders
of quarantine, isolation, or conditional release, including translation or interpretation
services as needed; (2) mandatory review of the Federal order after the first 72 hours;
(3) notifying individuals through the written order of their right to request a medical
review; (4) an opportunity at the medical review for the detained individual to be
heard through an attorney or other advocate hired at their own expense, present experts
or other witnesses, submit documentary or other evidence; and confront and cross-examine
any government witnesses; (5) a decision-maker independent of those who authorized
the original isolation, quarantine, or conditional release; (6) a written statement
by the fact-finder of the evidence relied upon and the reasons for the decision; (7)
appointment of representatives, including a medical representative and an attorney,
if the individual is indigent and requests a medical review; and (8) timely notice
of the preceding rights. See Vitek v. Jones, 445 U.S. 480 (1980); Matthews v. Eldridge, 424 U.S. 319 (1976).
HHS/CDC also received a comment that quarantine violates the guarantees of substantive
due process under the 5th Amendment to the U.S. Constitution. HHS/CDC disagrees. In
addition to a guarantee of fair procedures, the U.S. Supreme Court has interpreted
the Fifth Amendment’s Due Process Clause as containing a substantive component barring
certain arbitrary, wrongful government actions regardless of the fairness of the procedures
used to implement them. See Zinermon v. Burch, 494 U.S. 113, 125 (1990). HHS/CDC notes that the quarantine of individuals who have
been exposed to a communicable disease, but are not yet capable of transmission is
a well-known and accepted public health strategy of long standing. See Jacobson v. Massachusetts, 197 U.S. 11, 25 (1905) (recognizing the power of States to issue “quarantine laws
and health laws of every description”); Compagnie Francaise de Navigation a Vapeur v. State Bd. of Health, Louisiana, 186 U.S. 380, 396 (1902) (discussing the 1893 Federal quarantine statute). The restrictions
on individuals authorized under this regulation are justified by the benefits to the
public health.
HHS/CDC received a comment that quarantine and isolation are State police powers that
should not be exercised at the Federal level. While HHS/CDC acknowledges that the
States have primary authority for quarantine and isolation within their borders, the
Federal government has an important and longstanding role in preventing communicable
disease spread at ports of entry and interstate. This authority is reflected in
42 U.S.C. 264 and consistent with principles of Federalism.
HHS/CDC received one comment stating that it should conduct a Federalism analysis
because implementing the rule will require working with State health officials and
resources. Under Executive Order 13132, a Federalism analysis is required if a rulemaking
has federalism implications, would limit or preempt State or local law, or imposes
substantial direct compliance costs on State or local governments. Under such circumstances,
a Federal agency must consult with State and local officials. Federalism implications
is defined as having substantial direct effects on State or local governments, on
the relationship between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government. 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 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. While HHS/CDC acknowledges that portions of this rule may involve HHS/CDC “working
with State health officials” to better coordinate public health responses, the rule
is consistent with
42 U.S.C. 264(e) and there are no provisions that impose direct compliance costs on State and local
governments. The longstanding provision on preemption in the event of a conflict with
Federal authority (
42 CFR 70.2) is left unchanged by this rulemaking. Therefore, HHS/CDC believes that the rule
does not warrant additional consultation under Executive Order 13132.
HHS/CDC received several questions asking who would be responsible for the enforcement
of these regulations. One commenter questioned whether HHS/CDC would use “militarized
police or create [an] armed Federal police force to carry out these actions.” As explained
elsewhere, in keeping with current practice and existing law, law enforcement support
for quarantine or isolation orders will generally be provided by U.S. Customs and
Border Protection, U.S. Coast Guard, or other Federal law enforcement programs, but
[*6901] HHS/CDC may also accept voluntary State and local assistance in enforcing its Federal
orders. HHS/CDC will also continue to enforce its regulations in a manner consistent
with the Fourth Amendment and other provisions of the U.S. Constitution.
HHS/CDC received many comments on the definition of Agreement, largely expressing confusion and concern that such agreements would not be truly
voluntary. The intent of this provision was to provide HHS/CDC with an additional
tool to facilitate cooperation from individuals in regard to recommended public health
actions. In response to public comments, however, HHS/CDC has withdrawn this definition
and will not issue the proposed provisions on “Agreements.”
HHS/CDC did not receive public comment on the proposed definition of
Airline. However, consistent with HHS/CDC’s intent that this definition apply to common air
carriers, to improve clarity, we have removed the phrase “including scheduled or public
charter passenger operations operating in air commerce within the United States” and
removed the reference to
49 U.S.C. 40102(a)(3).
HHS/CDC received many comments on the proposed definition and provision regarding
Apprehension; a discussion of these comments is in the section below titled, “Apprehension and
Detention of Persons with Quarantinable Communicable Diseases.” The definition is
finalized as proposed.
HHS/CDC did not receive public comment on the proposed definition of Commander. Therefore, this definition is finalized as proposed.
HHS/CDC received a comment seeking clarity regarding the definition of Communicable Stage. The commenter stated that the definition for communicable stage may unnecessarily restrict social distancing powers because it appears limited to
human-to-human transmission and does not include human transmission via an intermediate
vector, such as mosquitoes or flea bites. HHS/CDC disagrees. The definition of communicable
stage includes transmission of an infectious agent either “directly or indirectly
from an infected individual to another individual.” Thus, HHS/CDC clarifies that indirect
transmission of an infectious agent may include transmission via an insect vector
as described by the commenter. This definition is finalized as proposed.
HHS/CDC received many comments on the proposed definition and provision regarding
Conditional Release; a substantive discussion of these comments is presented in the section below titled
Requirements Relating to Issuance of a Federal Order for Quarantine, Isolation, or
Conditional Release.
HHS/CDC is modifying the definition of Conditional Release under section 70.1 to remove the cross-reference to the definition of surveillance
as that term appears in current section 71.1. The definition of Conditional Release under section 70.1 tracks the definition of surveillance under section 71.1 and means
“the temporary supervision by a public health official (or designee) of an individual
or group, who may have been exposed to a quarantinable communicable disease to determine
the risk of disease spread and includes public health supervision through in-person
visits, telephone, or through electronic or internet-based monitoring.” HHS/CDC is
making this change to improve clarity and remove the need for the public to cross-reference
the definition of surveillance to understand the definition of Conditional Release as used in section 70.1.
This definition of Conditional Release under section 71.1 is finalized as proposed.
HHS/CDC did not receive public comment on the proposed definition of Contaminated Environment. Therefore, this definition is finalized as proposed.
HHS/CDC did not receive public comment on the proposed definition of Conveyance. Therefore, this definition is finalized as proposed.
HHS/CDC received many comments on the proposed definition and provision regarding
Electronic or Internet-based monitoring. We have modified this definition as follows: “mechanisms or technologies allowing
for the temporary public health supervision of an individual under conditional release
and may include communication through electronic mail, SMS texts, video or audio conference, webcam technologies, integrated
voice-response systems, or entry of information into a web-based forum; wearable tracking
technologies; and other mechanisms or technologies as determined by the Director or
supervising State or local health authority.”
Several commenters expressed privacy concerns because conditional release of exposed
or ill individuals may be accomplished over the internet or through electronic monitoring.
Other commenters expressed concerns about privacy, having misunderstood the proposed
rule as authorizing HHS/CDC to conduct invasive surveillance of personal communications
such as emails, text messages, and telephone calls. Commenters also expressed concerns
related to the use of webcams and wearable tracking technologies as an option for
monitoring of exposed people. One association viewed this proposed provision as an
expansion of CDC’s “electronic monitoring of personal information, under the guise
of protecting the public against rare, isolated outbreaks of disease.”
HHS/CDC appreciates the opportunity to address these concerns. CDC’s intent was to
describe mechanisms that HHS/CDC or other public health authorities can use to communicate
with individuals for the purpose of conducting monitoring following exposure to a
quarantinable communicable disease. These mechanisms are intended as alternatives
to in-person interviews because of the inconvenience and logistical problems that
may arise when meeting in-person.
During the 2014-2016 Ebola response, HHS/CDC recommended “active monitoring” defined
as daily communication between public health authorities and the individuals being
monitored. HHS/CDC did not specify how this communication should occur, and health
departments used a variety of electronic technologies for this purpose including those
listed in the regulation. HHS/CDC also recommended “direct active monitoring” for
people with certain higher levels of exposure. This involved having a public health
official check in with the person through direct observation rather than relying on
phone calls or electronic communications. Webcams were used by some health departments
as an alternative to in-person visits to observe the person taking his or her temperature.
The webcam was only operational during this scheduled public health “visit.” The use
of webcams proved convenient for both [*6902] the health departments and the people being monitored, especially if the people lived
in remote areas. Webcams are also used routinely by health departments for “directly
observed therapy” for diseases like tuberculosis (TB), in order to watch patients
take their TB medications. HHS/CDC has clarified the regulatory text to state that
these technologies will be used for communicating with the individual and not as a
means of monitoring the individual’s personal communications.
One commenter asked whether HHS/CDC would “assist with payment for internet services”
if webcam communications was required. In keeping with current practice, if an individual
does not have access to internet services, HHS/CDC may use alternative methods to
assist with communication, such as the issuance of a cellular phone. Some organizations
also expressed concerns about the use of technologies such as cellular phones or wearable
tracking technologies for the purpose of electronic monitoring. HHS/CDC acknowledges
that the use of wearable tracking technology may be necessary in rare situations when
a person does not comply with the required monitoring or when it is necessary to know
the physical whereabouts of the person to ensure that they are not in a public place.
While HHS/CDC acknowledges that public health surveillance of ill or exposed individuals
through electronic monitoring may raise some privacy concerns, HHS/CDC believes that
protecting the public’s health outweighs these concerns.
HHS/CDC is committed to protecting the privacy of personally identifiable information
collected and maintained under the
Privacy Act of 1974. As detailed in the preamble of the proposed rule, on December 13, 2007, HHS/CDC
published a notice of a new system of records under the
Privacy Act of 1974 for its conduct of activities under this final rule (
72 FR 70867). HHS/CDC accepted public comment on its proposed new system of records at that time.
As required under the
Privacy Act, HHS/CDC described in its notice the proposed system of records, the purpose for
the collection of the system data, the proposed routine uses (
i.e., disclosures of system data that are compatible to the purpose for the data collection),
the benefits and need for the routine use of this data, our agency’s policies, procedures,
and restrictions on the routine use disclosure of this information, and, most importantly,
our safeguards to prevent its unauthorized use.
Under this system of records, CDC will only release data collected under this rule
and subject to the
Privacy Act to authorized users as legally permitted. HHS/CDC will take precautionary measures
including implementing the necessary administrative, technical and physical controls
to minimize the risks of unauthorized access to medical and other private records.
In addition, HHS/CDC will make disclosures from the system only with the consent of
the subject individual or, in accordance with the routine uses published at
72 FR 70867, or as allowed under an exception to the
Privacy Act. Furthermore, HHS/CDC will apply the protections of the SORN to all travelers regardless
of citizenship or nationality. Finally, such records will be stored and maintained
in keeping with the official Records Control Schedule as set forth by the National
Archives and Records Administration. For more information, please see
https://www.archives.gov/records-mgmt/rcs.
We have modified the definition of
Ill person under 71.1 to include a person who “(b)(2) Has a fever that has persisted for more
than 48 hours; or (b)(3) Has acute gastroenteritis, which means either diarrhea, defined
as three or more episodes of loose stools in a 24-hour period or what is above normal
for the individual, or vomiting accompanied by one or more of the following: One or
more episodes of loose stools in a 24-hour period, abdominal cramps, headache, muscle
aches, or fever (temperature of 100.4 °F [38 °C] or greater).” This language was quoted
verbatim in the preamble of the NPRM at
81 FR 54305 but was inadvertently omitted from the proposed regulatory text.
HHS/CDC received comments regarding the updated definition of Ill person which flight crews use to report to the CDC occurrences of illnesses in passengers
or crew during travel. Specifically, commenters expressed concern that “non-medical
personnel” such as flight attendants would report such observations; others questioned
whether the definition is too broad and may result in over-reporting of non-threatening
illnesses; others worried that it could lead to unnecessary apprehensions of individuals.
One commenter claimed to be “chemical sensitive,” and worried that he or she may be
penalized for having a reaction from sitting next to someone on a plane wearing a
“strong fragrance.” HHS/CDC thanks the commenters for considering the proposal and
providing feedback.
HHS/CDC clarifies that the purpose of the ill person definition is to align with current global and accepted detection and reporting practices
so that onboard deaths and illnesses are reported by airlines and, where necessary,
investigated by HHS/CDC. We note that the ill person definition in this final rule is consistent with the internationally recognized and
accepted illness reporting guidelines published by the International Civil Aviation
Organization (ICAO). This practice is not new, but has been used successfully for
many years by aircraft and vessel crews to assist public health officials in preventing
further transmission and spread of communicable disease.
HHS/CDC also does not intend to apprehend individuals based solely on their meeting
the definition of an ill person. The purpose of an illness report is to allow trained HHS/CDC public health and medical
officers to determine whether an illness occurring onboard a flight or voyage necessitates
a public health response. In contrast, an apprehension of an individual is based on
a variety of criteria in addition to an illness report including: Clinical manifestations,
contact or suspected contact with infected individuals, host susceptibility, travel
to affected countries or places, or other evidence of exposure to or infection with
a quarantinable communicable disease. Thus, HHS/CDC disagrees that the ill person
definition will lead to unnecessary apprehensions of individuals.
Several commenters noted that the symptoms listed in HHS/CDC’s definition of an ill person are common symptoms of many non-threatening conditions, and thus questioned their
inclusion in the definition. HHS/CDC appreciates the opportunity to respond to these
concerns. The symptoms listed in HHS/CDC’s ill person definition are provided for airlines and vessels to report to HHS/CDC so that HHS/CDC
can make a public health risk assessment; the symptoms alone would not result in issuance of a public health order. In making such an assessment, HHS/CDC medical and public health officers consider
the symptoms as well as the medical history of the person and any possible exposures
that could indicate that the person may be infected with a quarantinable communicable
disease.
A few commenters stated that the definition of ill person appears to expand the scope of HHS/CDC’s authority beyond the list of quarantinable
communicable diseases specified through an Executive Order of the President. HHS/CDC
disagrees. The [*6903] purpose of the ill person definition is to help facilitate the identification, particularly
by flight crews, of communicable diseases of public health concern. Thus, HHS/CDC
has defined ill person in such a way that the term may be understood by non-medically trained crewmembers.
While the reporting of an ill person onboard a flight may trigger a public health
evaluation by a trained quarantine officer in consultation with an HHS/CDC medical
officer, such reporting does not expand the basis upon which an ill person may be
subject to apprehension, detention, or conditional release. As noted by the commenter,
such public health actions are limited to those quarantinable communicable diseases
specified through an Executive Order of the President (e.g., cholera, diphtheria, infectious tuberculosis, yellow fever, viral hemorrhagic fevers,
Severe Acute Respiratory Syndromes, and pandemic influenza).
A public health association suggested that any changes to the list of signs and symptoms
within the definition of ill person should be made available for public comment. HHS/CDC assumes this comment is in reference
to section (3) of the definition which provides for reporting of “symptoms or other
indications of communicable disease, as the HHS/CDC may announce through posting of
a notice in the Federal Register.” HHS/CDC appreciates the opportunity to clarify the purpose of this section. Section
(3) of the ill person definition is intended to apply only to new, emerging, and imminent threats to public
health. We expect it will only be relied on in emergency situations where a quick
response is required to protect the public. Other circumstances, where the list of
signs and symptoms may change due to evolving science or technology, will be made
available for public comment, through a similar process as this rulemaking—Notices
in the Federal Register—and may also request input from the public.
A number of commenters noted that symptoms listed in HHS/CDC’s definition of an ill person are common symptoms of many conditions, particularly “appears obviously unwell” which
many commenters requested be removed from the definition. HHS/CDC appreciates the
opportunity to clarify that, with the exception of acute gastroenteritis on vessels,
HHS/CDC only requires reporting of an ill traveler on an aircraft or vessel if fever “accompanied by one or more of the following” other symptoms listed are present. Therefore, as an example, headache alone would not be sufficient to require reporting,
but rather fever plus headache, fever plus cough, fever plus persistent vomiting,
fever plus persistent diarrhea, etc. These symptoms combined with fever are frequently
seen in communicable diseases that could pose a public health risk to others during
travel. Because a person with fever who also appears obviously unwell could have a
serious communicable disease, HHS/CDC feels it is appropriate to retain this symptom,
and further notes that its inclusion better aligns with Note 1 to the guidelines set
forth by the International Civil Aviation Organization in paragraph 8.15 of Annex
9 to the Convention on International Civil Aviation.
One public health organization commented that the definition of ill person was broad and would be better issued through agency guidance rather than a rule.
In response, HHS/CDC notes that the existing regulation contains an outdated and overly
narrow definition of ill person that does not reflect current knowledge of communicable diseases, and that the reporting
of ill travelers has been managed through a combination of regulation and agency guidance.
This combination of “required” and “requested” reporting has proven confusing to some
airline and vessel employees and this rule seeks to mitigate such confusion by including
all relevant symptom clusters in the rule. Further, HHS/CDC notes that the change
in the ill person definition better aligns with guidelines set forth by the International Civil Aviation
Organization and is supported in comments received from the airline industry.
One public health organization commented on the different definitions of ill person for aircraft and vessels and recommended that the definitions be combined and not
depend on the mode of transport. In response, HHS/CDC wishes to point out three crucial
differences between aircraft and vessels which HHS/CDC feels justify the different
definitions. One difference, additionally noted by the commenting organization, is
the difference in time that a traveler spends on an aircraft and a vessel which makes
the time frame (24 hours) specified in the definition of acute gastroenteritis for
vessels relevant and minimizes the reporting of travelers with a single episode of
loose stool that subsequently resolves, a common occurrence. The second is the high
risk of spread of gastrointestinal infections onboard vessels that is unlikely to
occur on aircraft; for this reason, reporting of diarrheal illnesses on aircraft includes
the presence of fever which is more likely to indicate a serious communicable disease,
whereas the definition on vessels includes diarrheal illness without fever to allow
for the reporting of viral gastrointestinal illnesses that typically do not cause
fever but have been known to cause large outbreaks on cruise vessels. The third difference
is the presence onboard cruise vessels of medical facilities capable of making a diagnosis
of pneumonia which allows the inclusion of pneumonia in the vessel definition. In
all other respects, the definitions are the same. HHS/CDC adds that combining the
definitions would be confusing to industry professionals responsible for conducting
this reporting.
One public health organization provided a recommendation to modify the description
of the “rash” component in the definition of ill person to ensure that the term fully
encompassed the range of potential skin rash symptoms. The organization’s recommendation
for revisions was as follows: “The individual has areas on the skin that are red or
purple, flat or bumps; with multiple red bumps; red, flat spots; or blister-like bumps
filled with fluid or pus that are intact, draining, or partly crusted over; or dry
and scaling patches. The rash may be discrete or run together, and may include one
area of the body, such as the face, or more than one area.”
An air industry commenter suggested another change to the ill person definition. The
proposed definition included “headache with stiff neck,” and the commenter suggested
that this be modified to “severe headache of recent onset with stiff neck.” While
HHS/CDC will not change the regulatory definition of ill person to accommodate this
change, HHS/CDC believes this is a useful modification to make in ill person reporting
guidance to aircraft and vessels.
HHS/CDC did not receive any comments on the proposed definition of Incubation period. However, upon a [*6904] review of the definition, we have decided that the definition should more closely
track the definition of Precommunicable stage. For quarantinable communicable diseases, the Incubation period is defined as the Precommunicable stage of the disease. Thus, we have determined that the two definitions should more closely
align. A substantive discussion of comments received concerning the definition of
Precommunicable stage appears below.
Accordingly, we have modified the definition of Incubation period to add “or, if signs and symptoms do not appear, the latest date signs and symptoms
could reasonably be expected to appear.” Other aspects of this definition are finalized
as proposed.
HHS/CDC received comments relating to the proposed definition of Indigent which is used to determine whether a detained individual qualifies for appointment
at government expense of representatives to assist him/her during a medical review.
One comment from a public health department suggested raising the threshold for indigent
status to at least 200% of the applicable poverty guideline. HHS/CDC agrees and has
made this change in the final regulation.
One commenter opposed including a definition for indigents and indicated that HHS/CDC
should assume all costs whenever an individual is placed into Federal isolation or
quarantine. HHS/CDC disagrees that assuming such costs without regard to indigence
is necessary or appropriate.
Other substantive comments relating to the appointment at government expense of representatives
to assist detained indigent individuals during a medical review are discussed below.
HHS/CDC did not receive any comments on the definition of Master or operator. Accordingly, this definition is finalized as proposed.
In response to comments received regarding medical examinations under sections 70.12
and 71.36, we have modified the definition of Medical Examination to indicate that the health worker conducting the assessment must be “licensed.”
Comments regarding sections 70.12 and 71.36 are addressed below.
HHS/CDC received a comment regarding the definition of Medical Examination. The commenter stated that the definition of medical examination should include a
mental health assessment because a mental health condition may impact an individual’s
appreciation of his or her public health risk to others. While HHS/CDC acknowledges
that a mental health assessment may be useful as part of an individual’s medical care
and treatment and that such an assessment may be ordered as needed by a treating clinician,
HHS/CDC declines to make such assessments a formal part of the medical examination
process. Specifically, because a mental health assessment is not generally needed
to diagnose or confirm the presence or extent of infection with a quarantinable communicable
disease, HHS/CDC disagrees that it is necessary or appropriate to require such an
assessment as part of a Federal public health order.
HHS/CDC received several comments relating to the proposed definitions of Medical Representative and Medical Reviewer as well as the potential use of HHS/CDC employees as representatives or medical reviewers.
One commenter suggested that it would be less problematic for HHS/CDC to allow and
pay for outside participants to serve in these capacities. First, HHS/CDC notes that
the definition of Medical representative has been changed to Representatives and revised as detailed below. HHS/CDC disagrees with this comment and notes that
the definition of both Representatives and Medical reviewer would in fact allow for the appointment of non-HHS/CDC employees in these capacities
as suggested by the commenter. For this reason, both Representatives and Medical reviewer are broadly defined in terms of the occupational qualifications of these individuals.
HHS/CDC also does not consider it problematic to rely on internal reviewers and notes
that it is not unusual, for instance, for hospitals to rely on internal decision-makers
when determining whether to commit a mental health patient on an emergency basis.
HHS/CDC received a comment that the “definition of medical exemption is not apparent.”
In response, HHS/CDC notes that no clarification of what is meant by “medical exemption”
is provided by the commenter and that HHS/CDC did not propose adding such a definition.
While these regulations do not authorize compulsory vaccination or medical treatment,
there is no recognized “medical exemption” from quarantine, isolation, or conditional
release and HHS/CDC declines to create one.
HHS/CDC received several comments concerning the definition of Non-invasive, including support from a public health association regarding the definition. However,
several individuals disagreed with the proposed definition. In response to public
comment that the definition of “non-invasive” allowed too much physical contact between
the individual and public health officer, HHS/CDC has replaced “physical” with “visual”
and removed “auscultation; external palpation; external measurement of blood pressure”
from the definition. While HHS/CDC continues to believe that these procedures qualify
as Non-invasive under the definition, after considering public comment and a review of standard operating
procedures, HHS/CDC finds such procedures to be unlikely to be conducted during a
public health risk assessment. Such procedures may be conducted at a port of entry
by emergency medical service personnel as part of a medical assessment to determine
the need for emergency medical care. We also modified the definition to clarify that
the individual conducting the public health risk assessment will be a “public health
worker.” Public health workers are individuals who have education and training in
the field of public health.
One commenter mentioned that the new definition of Non-invasive states that the HHS/CDC could order laboratory testing under certain conditions.
The commenter further asserted that forced laboratory testing, without the option
of quarantine instead, is an invasive measure, and questioned how this could be in
line with the concept of non-invasive. HHS/CDC responds that the definition of non-invasive
applies to procedures conducted during a public health risk assessment at a port of
entry and that this definition does not authorize forcible or invasive procedures
to extract human biological samples for laboratory testing. Should laboratory testing
be needed for a person reasonably believed to be infected with a quarantinable communicable
disease, such testing would be done as part of a medical examination conducted at
a healthcare facility and performed with the patient’s informed consent. HHS/CDC has
added language to the regulatory text requiring that the Director advise individuals
of their right to have medical testing and examination conducted by an authorized
and licensed health worker and with prior informed consent. While this regulation
does not authorize forcible testing, [*6905] HHS/CDC may require laboratory test results demonstrating that a symptomatic individual
is no longer infectious prior to rescinding a Federal isolation order.
HHS/CDC received comments relating to the definition of Precommunicable stage. One commenter suggested that persons in the “precommunicable stage” of a quarantinable
communicable disease pose no direct threat to the public’s health. A public health
organization also stated that this definition should not apply to non-symptomatic
people who have been exposed to Ebola. HHS/CDC disagrees with both comments. For instance,
a patient diagnosed with multidrug-resistant or extensively drug-resistant tuberculosis
who is not currently infectious, but who has not been adequately treated and is thus
at high risk for relapse would be considered to be in the “precommunicable stage”
of the disease and pose a direct threat to the public’s health. Similarly, an individual
who is reasonably believed to have been exposed to Ebola poses a direct threat.
Several public health organizations additionally expressed concerns regarding the
use of the “precommunicable stage” definition to justify quarantine of healthcare
workers caring for patients with quarantinable communicable diseases such as Ebola
or severe acute respiratory syndromes, including healthcare workers providing care
in the United States or in other countries. One such organization further requested
clarification of whether the rule provides for the needs and protection of healthcare
workers who voluntarily self-quarantine while providing care for patients with the
quarantinable communicable diseases noted above.
In response, HHS/CDC states that it does not recommend quarantine or occupational
restrictions of healthcare workers who follow recommended infection control precautions
while providing care for patients with quarantinable communicable diseases. Healthcare
workers who do not follow infection control precautions or who have had unprotected
exposures to patients with a quarantinable communicable disease may be subject to
quarantine or occupational restrictions; these individuals would be afforded the same
due process protections as other exposed individuals.
Several commenters also questioned CDC’s proposed definition for Precommunicable stage stating that it may result in an apprehension of an individual who displays no symptoms
of a communicable illness. In response, HHS/CDC states that it has defined Precommunicable stage consistent with the public health practice of quarantine. Quarantine refers to the
public health practice of separating and restricting the movement of individuals who
are reasonably believed to have been exposed to a communicable disease, but are not
yet ill. In contrast, isolation refers to the public health practice of separating
and restricting the movement of individuals who have been exposed to a communicable
disease and are symptomatic from those who are not sick.
The definition of Precommunicable stage is finalized as proposed.
HHS/CDC received several comments relating to the definition of
Public health emergency. One commenter stated that use of the term is duplicative and unnecessary because
the term is used elsewhere in the
Public Health Service Act (
42 U.S.C. 247d) and appears in State-based legislation based on the Model State Emergency Health
Powers Act. This commenter suggested that to avoid confusion the term should be renamed
“Public Health Exigency.” HHS/CDC disagrees. Section 361(d) of the
Public Health Service Act (
42 U.S.C. 264(d)(1)) authorizes the apprehension and examination of individuals traveling interstate
who are in the “precommunicable stage” of a quarantinable communicable disease, but
only if the disease “would be likely to cause a public health emergency if transmitted
to other individuals.” Thus, section 361(d) is unique and differs from how the term
public health emergency is used in other statutes or provisions of the
Public Health Service Act because it authorizes application of specific public health measures (apprehension
and examination) to specific individuals (those in the precommunicable stage of a
quarantinable communicable disease), but only if the disease would be likely to cause
a public health emergency. Thus, HHS/CDC considers it essential to define public health
emergency because the existence of such an emergency is a necessary prerequisite to
the apprehension and examination of individuals in the precommunicable stage of a
quarantinable communicable disease.
This commenter also suggested that the definition of public health emergency contains
an oversight because it does not mention the potential for an infectious condition
being highly likely to cause “short- or long-term disability.” HHS/CDC disagrees because
the definition includes infectious diseases that are highly likely to cause “serious
illness” if not properly controlled. HHS/CDC clarifies that “short- or long-term disability”
caused by an infectious agent would be considered a “serious illness.”
This commenter further suggested that in addition to referencing a public health emergency
declaration by the HHS Secretary, the definition should also include similar declarations
by the President under the
Stafford Act or under the
National Emergencies Act. HHS/CDC disagrees. We note first that the definition of public health emergency
is not limited to those emergencies declared by the HHS Secretary. Second, in the
event of a man-made or natural disaster that also affects public health, the HHS Secretary
may issue a separate declaration under the
Public Health Service Act as was done in response to the terrorist attacks of September 11, 2001 and in response
to Hurricane Katrina. Thus, HHS/CDC does not see a need to also reference Presidential
declarations as suggested by the commenter.
This commenter also requested clarification concerning whether the World Health Organization’s
(WHO) declaration of a Public Health Emergency of International Concern (PHEIC) could
continue to serve as the basis for a “public health emergency” if the President or
HHS Secretary disagreed with the declaration of a PHEIC on legal, epidemiologic, or
policy grounds. In response, HHS/CDC notes that the scenario proposed by the commenter
is unlikely, but that CDC remains a component of HHS, subject to the authority and
supervision of the HHS Secretary and President of the United States.
HHS/CDC also received a comment objecting to referencing the WHO’s declaration of
a Public Health Emergency of International Concern (PHEIC) in the definition of “public
health emergency” because this ostensibly relinquishes U.S. sovereignty. HHS/CDC disagrees.
By including references to a PHEIC, HHS/CDC is not constraining its actions or makings
its actions subject to the dictates of the WHO. Rather, the declaration or notification
of a PHEIC is only one way for HHS/CDC to define when the precommunicable stage of
a quarantinable communicable disease may be likely to cause a public health emergency
if transmitted to other individuals. While HHS/CDC will give consideration to the
WHO’s declaration of a PHEIC or the circumstances under which a PHEIC may be notified
to the [*6906] WHO, HHS/CDC will continue to make its own independent decisions regarding when a
quarantinable communicable disease may be likely to cause a public health emergency
if transmitted to other individuals. Thus, HHS/CDC disagrees that referencing the
WHO determination of a PHEIC results in any relinquishment of U.S. sovereignty.
The International Health Regulations are an international legal instrument that sets
out the roles of WHO and State parties in identifying, responding to, and sharing
information about public health emergencies of international concern. HHS/CDC believes
that it would be unlikely for the United States to formally object to the WHO’s declaration
of a PHEIC, but that CDC remains a component of HHS, subject to the authority and
supervision of the HHS Secretary and President of the United States.
Also regarding the definition of “public health emergency,” one public health association
expressed concern that any disease considered to be a public health emergency may qualify it as quarantinable.
Another commenter noted that some PHEICs “most certainly do not qualify as public
health emergencies” under the proposed definition. HHS/CDC appreciates the opportunity
to clarify. Only those communicable diseases listed by Executive Order of the President
may qualify as quarantinable communicable diseases. For example, Zika virus infection,
which although the current epidemic was declared a PHEIC by WHO, is not a quarantinable
communicable disease. The definition of Public health emergency is finalized as proposed.
HHS/CDC received one comment relating to the definition of Public health prevention measures. The commenter stated that the second use of “and other non-invasive means” should
be deleted from the definition of public health prevention measures as redundant. HHS/CDC disagrees because “observation, questioning, review of travel
documents, and records review” as cited in the definition appears to materially differ
from “other non-invasive means” that may be used as a part of public health prevention
measures such as temperature checks, visual observation, or visual examination of
the ear, nose, or mouth. Accordingly, HHS/CDC believes that the updated definition
provides greater clarity as written. Further information, including a discussion regarding
comments received on these proposed provisions, is discussed in the section below
titled Public Health Prevention Measures to Detect Communicable Disease. The definition is finalized as proposed.
HHS/CDC received several comments relating to
Qualifying stage. Several commenters, including one public health organization, expressed concern that
the definition was either too vague, too broad, or too confusing. One commenter suggested
that the definition for
Qualifying stage is confusing because it splits communicable diseases into a “precommunicable stage”
and a “communicable stage” and that a communicable disease would not be on the list
of Federal quarantinable communicable diseases if its spread did not already have
some potential to cause a public health emergency. In response, HHS/CDC notes that
the term “qualifying stage” is defined under
42 U.S.C. 264(d)(2) to include both a “precommunicable stage” and a “communicable stage” and that this
definition explicitly references diseases “likely to cause a public health emergency.”
Thus, while HHS/CDC may clarify and explain statutory terms through regulation, it
has no authority to change the language of the statute.
One public health organization recommended that HHS/CDC policy implementing the Qualifying stage definition acknowledge that a one-size fits all protocol is not appropriate because
different diseases have different transmission patterns and the need for isolation
and quarantine may differ. HHS/CDC agrees that the need for isolation and quarantine
may differ based on the disease and adds that it conducts a public health risk assessment
before issuing Federal public health orders. For example, HHS/CDC does not typically
issue Federal public health orders for cholera, a quarantinable communicable disease
as defined by Executive Order because the sanitation infrastructure in the United
States makes cholera transmission unlikely. HHS/CDC further notes that it typically
conducts the public health risk assessment in coordination with the State or local
health department of jurisdiction before issuing a Federal public health order.
Public health organizations and other commenters cautioned against apprehending individuals
or issuing public health orders when the risk of communicable disease spread during
the precommunicable period is low. HHS/CDC agrees and further adds that it will typically
conduct a public health risk assessment in coordination with State and local public
health officials to ensure that any restrictions imposed on an individual are commensurate
with the degree of risk and using the least restrictive means available.
The definition of Qualifying stage is finalized as proposed.
HHS/CDC received several comments regarding the definition of Reasonably believed to be infected, as applied to an individual. Several public health organizations expressed concern there could be undue burden
placed on healthcare facilities or health departments by greatly expanding the number
of individuals requiring health screening, medical examination and testing, or placed
under Federal isolation of quarantine orders. HHS/CDC disagrees. This rule represents
a codification of current practice and decisions regarding the need for medical examination
of individuals suspected of being infected with a quarantinable communicable disease,
including during an outbreak or public health emergency, will generally be based on
published disease-specific case definitions for PUIs (persons under investigation)
that incorporate clinical and epidemiologic factors. Furthermore, decisions regarding
the issuance of Federal public health orders or medical examination for a suspected
quarantinable communicable disease would typically be made in coordination with a
State or local health department of jurisdiction. Therefore, HHS/CDC does not anticipate
placing an undue burden on healthcare facilities or health departments as a result
of these definitions.
One commenter stated that the Reasonably believed to be infected, as applied to an individual definition allows for apprehension, quarantine, or isolation based solely on reasonable
inferences that the person was exposed somehow or in some way to infectious agents.
HHS/CDC disagrees because as stated in the definition reasonable inferences may only
be drawn from “specific articulable facts” that an individual has been exposed to
an infectious agent such as through “contact with an infected person or an infected
person’s bodily fluids, a contaminated environment, or through an intermediate host
or vector.” Thus, HHS/CDC disagrees that this standard does not comport with standard
public health practice.
HHS/CDC received a comment from a public health agency expressing concern that travel
to other countries where transmission of a quarantinable [*6907] communicable disease has likely occurred would be the sole basis upon which HHS/CDC
would form a reasonable belief that an individual may be infected with a quarantinable
communicable disease. In response, HHS/CDC clarifies that travel to other countries
was simply used as an illustrative example. The decision to place an individual into
isolation or quarantine will ordinarily be based on several factors, including travel,
contact with an infected person or an infected person’s bodily fluids, host susceptibility,
and clinical manifestations. HHS/CDC believes that this definition is clear and that
no further changes are necessary.
The definition of Reasonably believed to be infected as applied to an individual is finalized as proposed.
HHS/CDC has added a definition for Secretary meaning the Secretary of Health and Human Services (HHS) or any other officer or
employee of that Department to whom the authority involved has been delegated. We
note that while the NPRM did not propose this definition, the NPRM referenced the
Secretary in defining Public Health Emergency. Thus, HHS/CDC considers it useful to also define the term Secretary.
After consideration of comments regarding Definitions, HHS/CDC has made the following changes in the final rule:
• The definition of Agreements has been withdrawn.
• The definition of Conditional Release under section 70.1 has been modified to remove the internal cross-reference to the
definition of surveillance under section 71.1. The definition of Conditional Release under section 70.1 has been further modified to align with the definition of surveillance
under section 71.1 and means “the temporary supervision by a public health official
(or designee) of an individual or group, who may have been exposed to a quarantinable
communicable disease to determine the risk of disease spread and includes public health
supervision through in-person visits, telephone, or through electronic or internet-based
monitoring.”
• The definition of Electronic or internet-based monitoring has been modified to indicate “communication through” such means, and include “audio”
conference.
• The definition of Incubation period has been modified to add “or, if signs and symptoms do not appear, the latest date
signs and symptoms could reasonably be expected to appear.” This aligns the definition
with the Precommunicable stage definition.
• The definition of Indigent has been modified to increase the threshold to 200% of the applicable poverty guidelines.
• The definition of Medical Examination has been modified to indicate that the health worker conducting the assessment must
be “licensed.”
• The definition of Medical Representative has been changed to Representatives and now includes in addition to the appointment of a medical professional, the appointment
of “an attorney who is knowledgeable of public health practices.”
• The definition of Non-invasive has been modified to (1) replace “physical examination” with “visual examination,”
(2) specify that the individual performing the assessment must be a “public health
worker (i.e., an individual with education and training in the field of public health)” and (3)
remove “auscultation, external palpation, external measurement of blood pressure.”
• A definition for Secretary has been added and means “the Secretary of Health and Human Services (HHS) or any
other officer or employee of that Department to whom the authority involved has been
delegated.”
HHS/CDC received support from commenters on screening individuals entering the U.S.
from parts of the world where highly infectious diseases are common. One such commenter
requested to know the criteria HHS/CDC uses when deciding whether to detain an individual.
Another commenter stated that travel history “should be a prerequisite for Federal
orders to quarantine” and “medical exam should be a prerequisite for Federal orders
to isolate.” HHS/CDC thanks these commenters and welcomes the opportunity to explain
this process.
HHS/CDC’s decision to detain an individual is based on several criteria, including:
Clinical manifestations: Signs and symptoms consistent with those of a quarantinable
communicable disease; known or suspected contact with cases, i.e., patients either confirmed or suspected to be infected with a quarantinable communicable
disease; epidemiologic information/evidence (travel history, exposure to animals);
other documentary or physical evidence in the individual’s possession, such as a physician’s
note documenting infection with or medication for treatment of a quarantinable disease;
and/or public health authorities having notified HHS/CDC that the individual is known
or suspected to be infected with a quarantinable communicable disease and likely non-adherent
with public health recommendations.
HHS/CDC has modified paragraph (b) of the provisions relating to public health prevention
measures to detect communicable disease ( § § 70.10 and 71.20) to include information
about “known or possible exposure,” in response to comments requesting further clarity
of CDC’s criteria.
One organization from the airline industry was generally supportive of 70.10 and 71.20,
public health prevention measures to detect communicable disease, and requested that any measures, such as screening, occur prior to individuals boarding
an aircraft, and preferably prior to arrival at the gate. HHS/CDC thanks these commenters
for their support. In response, while an operational plan for each location has not
yet been finalized, HHS/CDC expects such measures to occur prior to the boarding of
an aircraft, and to the extent possible, prior to arrival at the gate. One airline
organization insisted that airline operators should not be financially responsible
for any costs associated with screening. HHS/CDC responds that it does not expect
airlines and airline operators to assume direct costs associated with public health
screening, such as providing additional personnel to conduct the screening. However,
indirect costs such as missed flights of passengers who are detained may occur.
Another airline organization requested that HHS/CDC ensure wait-times in lines are
not impacted by screening, and encouraged HHS/CDC to take into account the needs of
all stakeholders. HHS/CDC feels strongly that in these rare circumstances, which would
only occur should a threat to public health exist, preventing airline employees and
other passengers from being exposed to a detained or delayed individual provides a
greater benefit than the monetary loss of airfare. In keeping with current practice,
HHS/CDC will work together with public health partners, carriers, and all who have
equities, to ensure insofar as possible that the least restrictive and time-consuming
measures are implemented. Finally, commenters requested that individuals who refuse
to undergo a public health risk assessment prior to travel be denied boarding of an
aircraft. In response, HHS/CDC notes that individuals may be denied boarding for public
health reasons pursuant to the criteria published at
80 FR 16,400 (Mar. 27, 2015) titled
Criteria for Requesting
[*6908] Federal Travel Restrictions for Public Health Purposes, Including for Viral Hemorrhagic
Fevers.
HHS/CDC received a comment expressing concern about conducting public health prevention
measures at “other locations” besides U.S. ports of entry because the commenter found
this language vague. HHS/CDC clarifies that this term is meant to include all locations
where individuals may enter the United States from a foreign country (i.e., border crossings) or gather for the purposes of engaging in interstate travel (e.g., airports, seaports, railway stations, bus terminals), regardless of whether such
places are formally designated as such.
One public health organization requested clarification regarding what information
or event would justify triggering the screening of travelers. CDC’s response is that,
while specific triggers cannot be defined at this time, screening of travelers may
generally be conducted during a public health emergency if HHS/CDC determined that
monitoring of potentially exposed travelers was needed to protect the public’s health.
One public health organization and many individual commenters asserted that people
exposed to measles should not be “tracked” through the use of Federal public health
orders. First, we reiterate that because measles is not a quarantinable communicable
disease, HHS/CDC does not have the authority to issue a public health order for this
illness. Second, it is not HHS/CDC’s policy to monitor people following measles exposures.
Rather, HHS/CDC notifies State or local health departments regarding people in their
jurisdictions who may have been exposed to measles. The State or local health departments,
in turn, choose to notify people regarding their measles exposure, assess their immunity
to measles and, if they are not immune, offer vaccination with MMR vaccine to prevent
infection. State or local health authorities may choose to monitor people following
exposures to measles based on their own criteria.
One commenter asked whether mandatory health screenings at airports would be conducted
privately, whether processes would comply with HIPAA, and how data would be protected
at airports. In response, HHS/CDC states that, in all situations, HHS/CDC strives
to protect the privacy of individuals subject to screening, collection of information,
or the issuance of Federal public health orders under HHS/CDC’s authority. While some
aspects of the entry risk assessment process conducted during the 2014-2016 Ebola
epidemic were performed in areas of the airport that are not considered private, these
were limited to collection of contact information, noncontact temperature measurement,
observation for visible signs of illness, and superficial screening questions that
did not collect sensitive information. Any more detailed public health assessment
would be done in a private area.
HHS/CDC is bound by the
Privacy Act to protect personally identifiable data collected and maintained in accordance with
that Act. Furthermore, HHS/CDC will apply the protections of the SORN to all travelers
regardless of citizenship or nationality. Personally identifiable data collected by
HHS/CDC at airports are maintained in a secure database and shared only for official
purposes on a need to know basis using secure methods as described in CDC’s System
of Records Notice published at
72 FR 70867. HHS is also a hybrid entity under HIPAA, but only those parts of HHS that have been
determined to be health care components are subject to the HIPAA Privacy Rule. CDC
is generally not a health care component treated as a “covered entity” under the HIPAA
Privacy Rule. However, certain specific offices of HHS, CDC, and the National Institute
for Occupational Safety and Health (NIOSH) performing activities related to the World
Trade Center Health Program are considered health care components of HHS and must
comply with HIPAA and the Privacy Rule.
One public health organization recommended that the rulemaking specify that individuals
undergoing a public health risk assessment only be asked to provide contact tracing
information if the risk assessment leads to a reasonable belief that the individual
may become infected. It is CDC’s policy to conduct conveyance-related contact investigations
for confirmed cases of communicable diseases. In instances when confirmation cannot
be obtained, HHS/CDC may investigate contacts based on reasonable belief of infection
following a public health risk assessment which is typically conducted in coordination
with the State or local health department of jurisdiction. Such operational details
are generally defined in internal protocols. State or local authorities may conduct
community-based contact investigations within their jurisdictions based on their own
criteria.
After consideration of these comments, HHS/CDC has modified paragraph (b) the provisions
relating to Public Health Prevention Measures to Detect Communicable Disease ( § § 70.10 and 71.20) to include information about “known or possible exposure”
in the list of information that may be collected.
HHS/CDC received several comments relating to the “apprehension” of an individual.
One public health association and a public health department suggested that HHS/CDC
not use the term “apprehension” because this may create social stigma. HHS/CDC uses
this term in these regulations to align with the statutory terminology used in
42 U.S.C. 264(b) which authorizes the “apprehension, detention, or conditional release” of individuals
coming into a State or possession from a foreign country or possession for purposes
of preventing the introduction, transmission, and spread of quarantinable diseases.
Similarly,
42 U.S.C. 264(d) authorizes the “apprehension and examination” of any individual in the qualifying
stage of a quarantinable communicable disease who is moving or about to move between
States or constitutes a probable source of infection to individuals moving between
States. While HHS/CDC can clarify and explain this term, only Congress has the authority
to change statutory language. In addition to being a term specifically used in statute
under
42 U.S.C. 264, HHS/CDC has determined that this term best conveys that HHS/CDC may, based on public
health grounds, assume physical custody of individuals. Furthermore, using alternative
terminology, may reduce public understanding and transparency regarding HHS/CDC’s
legal authorities.
One commenter stated that not every social distancing technique needs to involve taking
physical custody of individuals and that using more voluntary-based options would
be advisable. HHS/CDC agrees that attempting to obtain voluntary compliance with public
health measures is more advisable than assuming legal custody, but believes that maintaining
the authority to apprehend individuals who may pose a public health risk is a necessary
tool to protect the public’s health. HHS/CDC received a comment regarding the “burden
of proof” for an apprehension. In response, HHS/CDC notes that the applicable standard
for an apprehension of an interstate traveler is “reason to believe” that the individual
is in the qualifying stage of a quarantinable communicable disease. HHS/CDC notes
that Reasonably believed to be infected as applied to an individual is defined under this final rule.
[*6909]
Several commenters expressed concern that because the “apprehension” period is not
explicitly time-limited, that HHS/CDC may “apprehend” an individual indefinitely without
providing the individual with a written public health order or a medical review. One
commenter noted that HHS/CDC used the term “generally” in the preamble of the NPRM
and felt it was too vague, stating “setting a firm timeframe is vital.” A partnership
of public health legal scholars and organizations stated that because HHS/CDC did
not explicitly limit how long an individual could remain apprehended that such apprehensions
could turn into the functional equivalent of a quarantine thus potentially raising
Fourth and Fifth Amendment concerns. In response to these concerns, HHS/CDC has added
language requiring that it serve an apprehended individual with a public health order
within 72 hours of that individual’s apprehension.
HHS/CDC received several other comments relating to the sections authorizing the apprehension
and detention of persons with quarantinable communicable diseases. A partnership of
public health legal scholars and organizations suggested two public health frameworks
for apprehension and detention, one for implementation during non-exigent circumstances
and a second for exigent circumstances. As described, the primary distinction between
the non-exigent and exigent framework, is that in the former HHS/CDC would be required
to hold a due process hearing prior to the imposition of an isolation or quarantine,
while in the latter HHS/CDC may briefly detain the individual prior to holding a hearing.
While HHS/CDC appreciates the input provided by this partnership, HHS/CDC declines
to adopt this suggestion. Importantly, unlike State and local public health authorities
who have primary responsibility for the imposition of public health measures occurring
within their jurisdictions, HHS/CDC acts in time-sensitive circumstances to prevent
communicable disease spread, such as at ports of entry, upon the request of a State
or local public health authority of jurisdiction, or when State or local control is
inadequate. Furthermore, unlike State and local public health authorities who generally
have broad police-power authority to protect the public’s health, HHS/CDC’s statutory
authority with respect to isolation and quarantine is limited to only those small,
subset of communicable diseases specified through an Executive Order of the President
as quarantinable. Accordingly, HHS/CDC does not foresee sufficient “non-exigent” circumstances
where it would be necessary for it to issue a Federal isolation or quarantine order
and thus declines to establish the suggested alternative framework on this basis.
The circumstances under which HHS/CDC may apprehend and detain individuals is limited
by the terms of
42 U.S.C. 264. HHS/CDC may only isolate, quarantine, or conditionally release an individual if
it reasonably believes that the individual is infected with a quarantinable communicable
disease and the individual is either arriving into the U.S. from a foreign country,
moving between States, or constitutes a probable source of infection to others who
may then move between States.
Accordingly, the circumstances under which CDC is would issue a quarantine or isolation
order are “exigent” because the individual constitutes a communicable disease risk
and is actively engaged in travel or constitutes a source of infection to others engaged
in travel. It is thus unnecessary and impractical to provide a “pre-deprivation” hearing
prior to quarantining or isolating the individual because he/she if released from
custody may be lost to public health follow-up and may expose others. HHS/CDC would
not quarantine or isolate an arriving traveler from a foreign country where a single
case of a communicable disease such as Ebola exists unless it reasonably believes
that the traveler arriving into the U.S. is infected with a quarantinable communicable
disease.
Commenters stated that individuals must receive notice of their suspected exposure
and be permitted to speak with legal counsel or have legal counsel appointed to them.
HHS/CDC agrees that individuals should be adequately notified of the basis for their
detention and directs this commenter to sections 70.14 and 71.37, which detail the
specific factual content that must be included in a Federal order for quarantine,
isolation, or conditional release. We have also modified these sections to explicitly
require that the federal order include an explanation of the right to request a medical
review, present witnesses and testimony at the medical review, and to be represented
at the medical review by either an advocate (e.g., family member, physician, or attorney) at the individual’s own expense, or, if indigent,
to have representatives appointed at the government’s expense.
As previously stated, consistent with principles of preventing communicable disease
spread, HHS/CDC will also take measures (such as ensuring phone access) to allow apprehended
individuals to have contact with family or legal counsel whom they hire at their own
expense. As explained further below, HHS/CDC will also appoint representatives, including
a medical representative and an attorney, if the individual is indigent and requests
a medical review. Individuals who do not qualify as indigent may also choose to be
represented at the medical review by an advocate (e.g., an attorney, physician, family member) and present a reasonable number of medical
experts, of their own choosing and at their own expense. HHS/CDC, however, rejects
as impractical the notion that indigent individuals should have representatives appointed
to them at the moment of apprehension because most illnesses of public health concern can be ruled out based on a short
interview with a quarantine officer involving an assessment of symptoms and travel
history. Thus, the expected length of an apprehension will be very short and not justify
the appointment of representatives.
This commenter also requested clarity on what legal recourse may be available to apprehended
individuals. While HHS/CDC does not express an opinion regarding what form of legal
action an aggrieved individual should pursue, we note that these regulations do not
impact the constitutional or statutory rights of individuals to seek judicial redress
for detention.
HHS/CDC received comments from the public regarding HHS/CDC’s authority to “arrest”
individuals. One commenter stated that individuals should only be detained when a
crime has been committed. One association objected to HHS/CDC’s “power to detain an
individual for 72 hours and longer without any Federal court order.” Some commenters
also worried that any person showing signs of a “common cold” may be held. To be clear,
HHS/CDC is not a law enforcement agency, it has no legal authority to “arrest” individuals,
but rather has been granted the authority by Congress to “apprehend and detain” individuals
for the purposes of preventing the introduction, transmission and spread of quarantinable
communicable disease as specified in an Executive Order of the President.
42 U.S.C. 264(b). This provision further provides that “regulations may provide that if upon examination
any such individual is found to be infected, he may be detained for such time and
in such manner as may be reasonably necessary.”
42 U.S.C. 264(d)(1). HHS/CDC strongly believes that these
[*6910] authorities may be implemented in a manner consistent with the U.S. Constitution.
Furthermore, during the period of apprehension, HHS/CDC will arrange for adequate
food and water, appropriate accommodation, appropriate medical treatment, and means
of necessary communication.
HHS/CDC received comments from the public inquiring about the criteria that HHS/CDC
uses to determine whether an individual should be detained and assessed. As provided
for in the regulation, HHS/CDC may apprehend, examine, isolate, and quarantine such
individuals to protect the public’s health. In determining whether an individual poses
a threat to public health, HHS/CDC has developed and uses the following criteria:
Clinical manifestations: Signs and symptoms consistent with those of a quarantinable
disease; known or suspected contact with a case, i.e., patients either confirmed or suspected to be infected with a quarantinable disease;
epidemiologic information/evidence (travel history, exposure to animals); other documentary
or physical evidence in the individual’s possession, such as a physician’s note documenting
infection with or medication for treatment of a quarantinable communicable disease;
and/or public health authorities have notified HHS/CDC that the individual is known
or suspected to be infected with a quarantinable communicable disease and non-adherent
with public health recommendations. This determination is typically made in consultation
and coordination with State and local public health authorities, as well as the treating
health care physician (when available). One public health association agreed that
travel history (entering the U.S. from a country where quarantinable diseases occur)
made sense for screening, but not for a quarantine or isolation order. HHS/CDC responds
that the criteria listed above, as well as those within the NPRM, are examples of
factors that HHS/CDC takes into consideration when determining the totality of the
circumstances—not one criterion does, should, or will, decide if the individual requires
a public health order.
One commenter questioned whether, regarding the list of quarantinable communicable
diseases listed by Executive Order of the President, a “common cold” would qualify
as a “severe acute respiratory syndrome” and therefore subject the ill individual
to a public health order. In response, we note that Executive Order 13295 (April 4,
2003), as amended by Executive Order 13375 (April 1, 2005) and Executive Order 13674
(July 31, 2014), explicitly excludes “influenza” from the definition of severe acute
respiratory syndrome.
HHS/CDC received several comments from a flight attendant union relating to apprehension
and detention of a flight crew. These comments include that the flight attendant’s
employer should be made aware of the apprehension, that HHS/CDC should limit the personal
health information that is shared with the employer, that the employer should treat
this information as confidential, and that those apprehended should be able to notify
families and their union. In response, HHS/CDC notes that it works closely with the
airline industry regarding potential occupational exposures to communicable diseases.
Furthermore, HHS/CDC notes that personally identifiable health information collected
and maintained under the
Privacy Act will be disclosed only with the consent of the subject individual, in accordance
with the routine uses published in HHS/CDC’s system of records notice (
72 FR 70867), or under an applicable exception to the
Privacy Act. While these regulations do not mandate how employers should treat the personal health
information of their employees, HHS/CDC agrees that such information should be treated
as confidential. Lastly, consistent with principles of preventing communicable disease
spread, HHS/CDC will allow persons detained in accordance with these regulations to
communicate with family, union representatives, legal counsel whom they hire at their
own expense, and others of their choosing. HHS/CDC will also appoint representatives,
including a medical representative and an attorney, if the individual is indigent
and requests a medical review.
One commenter asked about provisions for people detained under HHS/CDC’s authority
who require emergency medical care, and whether the need to conduct a public health
assessment could impede such care resulting in harm to the individual. In response,
HHS/CDC states that public health officers at ports of entry work closely with emergency
medical service (EMS) personnel and that emergency medical care takes precedence over
the public health risk assessment. When an individual suspected of being infected
with a quarantinable communicable disease requires emergency care, the individual
would be transported immediately by EMS to a medical facility, using appropriate infection
control precautions. The public health risk assessment would be completed subsequently
using information provided by the examining health care provider in coordination with
the health department of jurisdiction.
After consideration of these comments, HHS/CDC has finalized the Apprehension and Detention of Persons With Quarantinable Communicable Diseases ( § 70.6) provision as proposed, with the exception that Federal public health orders
must be served on the individual within 72 hours of an apprehension. As further detailed
below, the 72-hour period was determined based on public comment from health departments
familiar with the process, as well as CDC’s previous experience of the time necessary
to conduct a medical examination, collect and package laboratory specimens, transport
the specimens to an appropriate laboratory (when necessary), and conduct the testing.
HHS/CDC received several comments relating to medical examinations. HHS/CDC received
a comment from a public health agency stating that when an individual agrees to submit
to a medical examination, it may be more appropriate to medically examine the patient
during the “apprehension” period. In response, HHS/CDC notes that these regulations
do not prohibit voluntary compliance with public health recommendations in the absence
of a public health order. Notwithstanding, HHS/CDC believes that the ability to order
a medical examination as part of an order for isolation, quarantine, or conditional
release is an important tool to protect the public’s health. This agency also stated
that the definitions of “health status” and “public health risk” should be modified
to ensure that the medical examination contains the minimum requirements needed to
assess the communicable disease of public health concern. In response, HHS/CDC clarifies
that its sole purpose in ordering a medical examination would be to determine the
presence, absence, or extent of infection with a quarantinable communicable disease.
HHS/CDC notes, however, that the medical examination is conducted by clinical staff
who have primary responsibility for the patient’s medical care and treatment and that
a medical examination would thus ordinarily include the taking of a medical history
and physical examination. HHS/CDC believes that this definition is clear and that
no further modifications are needed.
HHS/CDC received a comment expressing concern that an individual would not be able
to choose his or her own clinical healthcare provider if [*6911] ordered to undergo a medical examination. One commenter raised concerns about the
possibility of medical examinations being conducted by “unqualified” or “non-medical
personnel.” In response, HHS/CDC clarifies that, in keeping with current practice,
any medical evaluation required by HHS/CDC would be conducted at a healthcare facility
by a licensed healthcare practitioner. Furthermore, HHS/CDC has determined that it
would be impractical to allow individuals to choose their own medical examiners. HHS/CDC
notes that among other considerations, it must ensure that the healthcare facility
where the medical examination will be conducted has appropriate containment facilities,
that necessary laboratory samples will be properly collected, and that it is HHS/CDC’s
practice to coordinate closely with State and local public health authorities in the
choosing of clinical healthcare providers. Accordingly, we have concluded that the
public interest is best served by having HHS/CDC, in coordination with the local health
authority and EMS, choose the healthcare facility where the medical examination will
be conducted and not the detained individual.
One commenter expressed concern that nonmedical personnel may be allowed to make a
determination of illness resulting in actions being taken based on potential misdiagnosis.
HHS/CDC appreciates the opportunity to clarify this point. Decisions to issue Federal
public health orders are based on the assessment of qualified and licensed physicians.
These decisions are based on all available evidence, including clinical presentation,
medical and exposure history, and the results of medical evaluation and laboratory
testing. Treatment decisions are made by the individual’s treating physician with
guidance from public health subject-matter experts.
One commenter suggested that medical examinations should be conducted only with the
informed consent of the individual and should not “forcibly” be required. HHS/CDC
clarifies that it may require a medical examination under
42 U.S.C. 264(d) because this section, among other things, authorizes the “apprehension and examination”
of individuals reasonably believed to be infected with quarantinable communicable
diseases in a qualifying stage. CDC, however, agrees that medical examinations may
not be conducted “forcibly.” Furthermore, because medical examinations will typically
occur in a hospital setting and be performed by clinical staff, it will be incumbent
upon clinical staff to obtain the patient’s informed consent consistent with established
standards of medical practice.
Public health organizations provided several comments regarding medical examinations,
including that they be performed promptly so as not to curtail liberty, include only
minimal components necessary to establish the diagnosis of or rule out the quarantinable
communicable disease of concern, and that specimens obtained during such examinations
not be used for purposes other than diagnostic testing without informed consent. In
response, HHS/CDC states that it agrees with all of these points and that CDC, in
keeping with current practice, has a commitment to upholding the highest ethical standards
for both medical care and research.
One public health organization asked for clarification of whether hospital staff would
be involved in obtaining consent for medical examinations authorized under this rule.
In response, HHS/CDC states that, while a public health order authorizes that a medical
examination be conducted, should any invasive procedures be determined by the treating
clinician to be necessary for diagnostic or treatment purposes, consent for such procedures
should be obtained by medical staff in accordance with established standards.
One organization asked for clarification of the location where medical examinations
would be conducted, including whether inpatient or ambulatory-care facilities would
be included. HHS/CDC responds that it will coordinate with State or local health departments
of jurisdiction concerning such operational details as the exact locations where medical
examinations may be conducted.
Several public health organizations commented on whether the issuance of public health
orders is needed prior to medical examination if individuals agree voluntarily to
such examinations, noting that a requirement for the issuance of orders could impede
or delay the medical examination and that the examination, itself, could determine
whether such orders are needed. In response, HHS/CDC notes that it may choose not
to exercise its authority to issue public health orders if an individual complies
voluntarily with HHS/CDC’s requirements, including the requirement of a medical examination.
However, HHS/CDC retains the right to issue an order requiring a medical examination
should an individual not comply voluntarily. Of note, one public health organization
supported the use of Federal public health orders in requiring medical examinations,
stating that such orders had been used effectively in the past to facilitate timely
examination.
One public health organization requested that language be added to the rule stating
that medical examinations will be performed with proper adherence to worker safety
and health policies and protocols. HHS/CDC responds that such occupational health
protections are beyond the scope of this regulation and are covered by regulations
of the Occupational Safety and Health Administration (OSHA).
HHS/CDC received several comments from a flight attendant union relating to medical
examinations. This organization stated that the regulations should mandate that an
employer pay a flight attendant’s salary and per diem and that no flight attendant
should incur discipline as a result of being absent from work. This organization further
commented that any changes in the employer-employee relationship should be addressed
through joint guidance between government and industry groups. This group also commented
that “promptly” should be defined in terms of the length of time that may be needed
to arrange for a medical exam and that no more than five hours would be reasonable.
This group further stated that “reasonably believed” should be defined to require
specific, articulable facts that a trained medical professional can articulate.
HHS/CDC responds that these regulations do not alter, define, or mandate the employer-employee
relationship between flight attendants and their employers. In regard to the timeframe
for arranging a medical examination, HHS/CDC rejects a specific 5-hour timeframe as
too prescriptive, but agrees that the medical examination should be arranged as quickly
as possible based on the circumstances of the event. HHS/CDC further notes that the
definition of “reasonably believed to be infected” already requires the existence
of “specific articulable facts” articulated by a public health officer. Such specific,
articulable facts would, for instance, include “contact with an infected person or
an infected person’s bodily fluids, a contaminated environment, or through an intermediate
host or vector.”
HHS/CDC received a comment from a partnership of public health legal scholars and
organizations expressing concern that the regulations do not appear to limit the invasiveness
of a medical examination, so long as the examination itself is needed to diagnose
or determine the presence or extent of infection with a quarantinable communicable
disease. HHS/CDC [*6912] welcomes this opportunity to provide further clarifications. HHS/CDC notes that because
medical examinations will occur in a hospital setting and be performed by the hospital’s
clinical staff, it will be incumbent upon clinical staff to obtain the patient’s informed
consent consistent with established standards of medical practice prior to any examination
occurring and that such examinations may not be forcibly conducted. HHS/CDC has also
added a requirement that the Director, as part of the Federal order, the individual
that the medical examination shall be conducted by an authorized and licensed health
worker with prior informed consent. Furthermore, HHS/CDC will implement this provision
consistent with U.S. constitutional requirements and Articles 23 and 31 of the International
Health Regulations, which requires that parties apply “the least intrusive and invasive
medical examination that would achieve the public health objective.”
After consideration of these comments, HHS/CDC has finalized the provisions relating
to Medical Examination ( § § 70.12 and 71.36) as proposed, with the exception that the Director as part
of the Federal order must advise the individual that the medical examination will
be conducted by an authorized and licensed health worker with prior informed consent.
HHS/CDC received several comments relating to the issuance of Federal orders for isolation
or quarantine. A flight attendant union commented that crew lists should not be published
as part of a quarantine order posted in a conspicuous location. This group further
stated that quarantine orders for flight attendants should be treated differently
than those applicable to passengers or other airline personnel because flight attendants
are health and safety personnel trained in how to perform CPR and operate defibrillators.
In response, HHS/CDC notes that if a public health order is publicly posted, the order
will be written to refer to a group of individuals, such as all individuals onboard
a particular affected interstate or international flight. Under such circumstances,
HHS/CDC expects that all members of the group will receive individual copies of the
public health order. In some circumstances, CDC anticipates that issuance of a group
federal order to an individual may not be feasible—such as when the location of the
individual is unknown. Thus, HHS/CDC does not expect to publish the names of individual
passengers or crew as part of a publicly posted quarantine order. Furthermore, while
HHS/CDC agrees that flight attendants provide an important public health and safety
role, HHS/CDC disagrees that acknowledging this role requires the issuance of different
public health orders than those issued to other affected persons.
HHS/CDC received several comments requesting the “least restrictive” means with respect
to quarantine and isolation. HHS/CDC agrees and clarifies that in all situations involving
quarantine, isolation, or other public health measures, it seeks to use the least
restrictive means necessary to prevent spread of disease. Regarding quarantine, as
an example, during the 2014-2016 Ebola epidemic, HHS/CDC recommended monitoring of
potentially exposed individuals rather than quarantine. Most of these people were
free to travel and move about the community, as long as they maintained daily contact
with their health department. For some individuals with higher levels of exposure,
HHS/CDC recommended enhanced monitoring (involving direct observation) and, in some
cases restrictions on travel and being in crowded places, but did not recommend quarantine.
HHS/CDC has the option of “conditional release” as a less restrictive alternative
to issuance of an order of quarantine or isolation. Under a conditional release order,
the person would not be confined as long as the terms of the order were followed.
Should a quarantine or isolation order be deemed necessary, home quarantine or isolation
would be considered as a less restrictive option to confinement in a guarded facility
as long as this was determined to be safe for other household members, appropriate
based on the individual’s ability and willingness to follow all necessary precautions,
and based on the individual’s history of compliance with public health recommendations.
One public health organization requested that HHS/CDC specify the types of locations
of Federal quarantine and asked clarification of whether this would occur on lands
or property under Federal jurisdiction, and whether Federal or State standards would
apply to an individual quarantined on lands or property not under Federal control.
In response, HHS/CDC notes that operational issues such as the exact location of a
quarantine and whether Federal, State, and local orders would be issued separately
or concurrently would depend on individual facts and circumstances unique to each
case. HHS/CDC notes, however, that it is not unusual for the Federal government to
exercise jurisdiction concurrently with State and local governments.
One public health organization noted the longstanding difficulties faced by Federal,
State and local authorities in identifying suitable facilities for quarantining of
large groups of people (approximately 350, representing the potential complement of
travelers onboard an international flight), including the immediate availability of
such facilities in the event of an emergency. HHS/CDC acknowledges these difficulties
and affirms that it is actively working with Federal partners to identify suitable
locations to accommodate large groups of people while under a Federal public health
order.
One commenter stated, “If this is enacted . . . everyone who works with diseases .
. . CDC, WHO, Labs, Drs., nurses etc. would have to be arrested as potential carriers.”
HHS/CDC disagrees with this assertion. HHS/CDC is not a law enforcement agency and
does not have authority to arrest individuals. HHS/CDC’s authority to issue Federal
public health orders is limited to those diseases defined by Executive Order as quarantinable
communicable diseases. Furthermore, HHS/CDC does not recommend restriction of movement
for healthcare workers, laboratory workers, or others whose occupations involve working
with infectious pathogens as long as the recommended infection control precautions
are followed. Workers who do not take the necessary precautions or have unprotected
exposures to a quarantinable communicable disease may be subject to restrictions if
they meet the requirements for issuance of Federal public health orders.
Some commenters indicated that vaccination or treatment should not be “conditions”
under “conditional release.” HHS/CDC confirms that this final rule does not compel
mandatory vaccination or medical treatment of individuals. HHS/CDC clarifies that
when medically appropriate, vaccination or treatment, may be “conditions” of an individual’s
release from quarantine or isolation. Individuals consent to these conditions.
A public health agency commented that HHS/CDC should consider the conditions of confinement
to ensure that certain minimum requirements, such as access to telephones, and reasonable
accommodation of dietary restrictions, are observed. Specifically, such conditions
should be considered at different stages including as part of the issuance of an order,
during the mandatory reassessment, and as a part [*6913] of the medical review. In response, HHS/CDC notes that in addition to implementing
these regulations consistent with U.S. constitutional requirements, CDC’s implementation
will also be consistent with Article 32 of the International Health Regulations which,
among other things, requires that in implementing health measures under the IHR the
gender, sociocultural, ethnic and religious concerns of the traveler be taken into
consideration. Furthermore, Article 32 requires arranging for adequate food and water,
protection for baggage and other possessions, appropriate accommodation, appropriate
medical treatment, and means of necessary communication for those subject to public
health orders. Furthermore, as stated in the regulations, as part of a mandatory reassessment
and medical review, HHS/CDC will consider whether the least restrictive means are
being used to protect the public health. HHS/CDC, however, does not believe that it
is necessary for “conditions of confinement” to be formally considered as part of
an administrative review because many conditions of confinement, such as availability
of entertainment or other amenities, may be raised through informal means such as
making one’s concern known to the facility where the individual is being housed.
HHS/CDC received a comment from a public health agency noting that it should assume
the responsibility of providing translation and interpretation services when issuing
an order for quarantine, isolation, or conditional release, or when conducting a medical
review. HHS/CDC agrees and has incorporated these changes into the regulatory text.
HHS/CDC received a comment from a partnership of public health legal scholars and
organizations requesting clarification as to whether personal service will occur when
a quarantine order is issued on a group basis and posted in a conspicuous location.
In response, HHS/CDC notes that if a public health order is publicly posted, the order
will be written to refer to a group of individuals, such as all individuals onboard
a particular affected interstate or international flight. Under such circumstances,
HHS/CDC expects that all members of the group will receive individual copies of the
public health order, thus addressing any concerns about adequacy of notice. Because
HHS/CDC, however, cannot foresee all of the circumstances that may arise in an emergency
situation, HHS/CDC believes that it is appropriate for these regulations to authorize
service through posting or publication, but only when individual service is “impracticable.”
After consideration of these comments, HHS/CDC has modified the provisions regarding
requirements relating to issuance of a Federal order for quarantine, isolation, or conditional release ( § § 70.14 and 71.37). Paragraphs (a)(5) and (4) of these provisions have been
modified, respectively, to require that the federal order include an explanation of
the right to request a medical review, present witnesses and testimony at the medical
review, and to be represented at the medical review by either an advocate (e.g., family member, physician, or attorney) at the individual’s own expense, or, if indigent,
to have representatives appointed at the government’s expense. Paragraph (b) of these
provisions has been modified to require that a Federal public health order be served
within 72 hours of an individual’s apprehension. A new provision, paragraph (c), has
been added requiring that the Director arrange for translation and interpretation
services of the Federal order as needed.
A number of commenters were confused regarding the 72-hour period, believing this
period referred to the period of apprehension pending the issuance of a Federal public
health order and asked why 72 hours were needed. The 72-hour period proposed referred
to the timeframe in which HHS/CDC must conduct a mandatory reassessment of the continued
need for isolating or quarantining an individual following the service of a Federal
public health order. However, in response to public comments HHS/CDC has also added
in sections 70.14(b) and 71.37(b) a requirement that it serve the individual with
a Federal public health order within 72 hours of that individual’s apprehension.
Some commenters, including a public health association, supported the mandatory 72-hour
reassessment provision guaranteed by these regulations. One of these commenters also
suggested the time be re-evaluated periodically in the event that technology provides
a way of speeding up the diagnosis process; another suggested the time frame be expanded
to five days to account for weekends; one more commenter noted that circumstances
may arise where an additional 72 hours may be needed; and another commenter stated
that a second 72-hour reassessment should be required. HHS/CDC is committed to performing
a reassessment within 72 hours of the federal public health order being served on
the individual. If, at that time, HHS/CDC determines that the order was properly issued
and that a public health risk continues to exist, the order would either be continued
or HHS/CDC would work with the State and local health department to transfer custody.
In the event that HHS/CDC continues the order, the individual may request a medical
review at that time.
A few commenters stated that the reassessment of HHS/CDC’s orders should be conducted
in a shorter time period than 72 hours such as within 12 hours, performed electronically
and conducted by a 3rd party. While HHS/CDC appreciates the input provided by these
commenters, HHS/CDC finds these suggestions impractical. Medical examination to confirm
or rule out infection with a quarantinable communicable disease may require up to
72 hours to allow for laboratory testing. While some communicable diseases (typically
viral infections) may be diagnosed using molecular tests such as polymerase chain
reaction (PCR) that take several hours to perform, others require that the organism
be cultured to make a confirmed diagnosis or to conduct antimicrobial sensitivity
testing in order to provide appropriate treatment. This is typically needed for bacterial
infections, such as diphtheria or plague, and may take 48-72 hours (or longer) to
complete. For some infectious tuberculosis cases, laboratory confirmation may take
several weeks although preliminary molecular testing may assist in conducting an assessment
of risk sufficient to continue or rescind the order. Specimen transportation time
may also need to be factored in as testing for certain diseases is only available
at state public health laboratories or CDC.
While HHS/CDC is required by this provision to reassess the need for a Federal public
health order within 72 hours, HHS/CDC will immediately release individuals from detention
if at any time it receives information confirming the absence of infection with a
quarantinable communicable disease. We note that while the medical assessment is intended
primarily as a review of available medical records and other relevant information,
these regulations do not prohibit HHS/CDC from conducting the review electronically,
for instance by relying on electronic medical records. Furthermore, HHS/CDC disagrees
that relying on internal decision-makers for the reassessment is inappropriate or
undesirable and thus does not consider [*6914] it necessary to rely on a “3rd party.” However, the CDC official or employee conducts
the reassessment will not be the same person who issued the quarantine, isolation,
or conditional release order. Following the reassessment, the detained individual
may also request a medical review as described in these regulations.
HHS/CDC received a comment from a public health agency requesting clarification as
to whether all individuals within a group will receive individual due process when
a group order is issued. This agency also questioned the feasibility of providing
a mandatory reassessment and medical review for large groups. In response, HHS/CDC
confirms that if a group order is issued, all individuals within that group will be
accorded due process. Furthermore, HHS/CDC has provided flexibility in the regulations
to allow for a mandatory reassessment of the group order and consolidation of medical
reviews where appropriate.
HHS/CDC received a comment from a partnership of public health legal scholars and
organizations stating that while the rule requires consideration of least restrictive
means upon reassessment of an order and as part of the medical review, HHS/CDC must
also consider least restrictive means prior to the issuance of a quarantine or isolation
order. HHS/CDC agrees that all means short of assuming legal custody of the individual
including attempting to obtain voluntary compliance with public health measures should
be explored. HHS/CDC notes, however, that an isolation or quarantine order is typically
issued in time-sensitive situations where because of the exigent circumstances surrounding
the risk of communicable disease spread it is not immediately possible to explore
all available less restrictive means, including the appropriateness of a home environment,
instead of a hospital. For this reason, HHS/CDC has chosen the mandatory reassessment
and medical review as the appropriate time to conduct a formal assessment of least
restrictive means. To the extent that the commenters suggest that due process requires
more, we disagree. See Yin v. California, 95 F.3d 864, 870 (9th Cir. 1996) (recognizing that in searches and seizures justified
by special needs, the government does not have to use the least restrictive means
to further its interests); Stockton v. City of Freeport, Texas, 147 F.Supp.2d 642, 647 (S.D. Tex. 2001) (recognizing that the Fourth Amendment does
not require that a search or seizure be conducted through the least restrictive means,
but rather that the alleged personal invasion be reasonable under all of the circumstances).
After consideration of these comments, HHS/CDC has finalized the provisions relating
to mandatory reassessment of a Federal order for quarantine, isolation, or conditional
release ( § § 70.15 and 71.38) as proposed.
HHS/CDC received several comments arguing that its proposed medical review procedures
are deficient. Specifically, one commenter stated that assessment procedures should
be clearly communicated to all affected persons; that HHS/CDC should more clearly
delineate “less restrictive alternatives;” that affected individuals should have a
right to legal representation; and that access to independent judicial review is essential.
HHS/CDC agrees that it should clearly communicate review procedures to individuals
subject to Federal isolation, quarantine, or conditional release. We note that sections
70.14 and 71.37 have been modified to require that the federal order authorizing isolation,
quarantine, or conditional release include an explanation that the federal order will
be reassessed 72 hours after it is served on the individual and of the right to request
a medical review, present witnesses and testimony at the medical review, and to be
represented at the medical review by either an advocate (e.g., family member, physician, or attorney) at the individual’s own expense, or, if indigent,
to have representatives appointed at the government’s expense. We further note that
the provisions relating to medical reviews, sections 70.16 and 71.39 have been revised
to include new paragraphs (q) which states that “The Director shall arrange for translation
or interpretation services as needed for purposes of this section.”
Similarly, in regard to minor children or adults with a cognitive disability, HHS/CDC
will work with a competent guardian to ensure that procedures are clearly communicated.
In regard to less restrictive alternatives, HHS/CDC believes that it is not possible
to delineate with specificity all of the less restrictive options that may be available
because such determinations will inevitably be based on the individual circumstances
of each case, including the severity of the particular disease-causing agent, availability
of treatment options should the disease not be adequately contained, the patient’s
particular level of infectivity or communicability, appropriateness of the home environment,
and the individual patient’s understanding, ability, and willingness to comply with
less restrictive alternatives. For this reason, HHS/CDC has made consideration of
less restrictive alternatives a part of the medical review proceeding where evidence
may be submitted into the record, testimony obtained, and a recommendation provided
by the medical reviewer. As a general matter, however, HHS/CDC clarifies that less
restrictive alternatives would refer to reasonable and available alternatives that
are adequate to protect the public’s health other than confinement in a guarded facility,
such as home quarantine, directly observed therapy, or other forms of supervised release.
In response to concerns about legal representation, HHS/CDC has amended the definition
of “Medical representative” to “Representatives” and will now appoint “an attorney
knowledgeable of public health practices” in addition to a “physician, nurse practitioner,
or similar medical professional qualified in the diagnosis and treatment of infectious
diseases.” HHS/CDC hopes that by appointing both an attorney and a qualified medical professional for indigent individuals it will alleviate concerns
expressed by the public regarding the medical review process. We note that an attorney
may become “knowledgeable of public health practices” in a number of ways, for instance,
through prior representation of a public health agency or advocacy organization, training
provided by a public health or advocacy organization or other training that would
ordinarily occur through a Continuing Legal Education (CLE) event, law school coursework,
or through independent study. We further note that for individuals qualifying as indigent,
HHS/CDC intends to provide independent legal counsel from outside of the agency. In
doing so, HHS/CDC may employ a variety of mechanisms, such as through agreements or
memorandums of understanding with law school legal clinics, State or local bar associations,
or public interest groups representing indigent clients. Individuals who do not qualify
as indigent may choose to be represented at the medical review by an advocate (e.g., an attorney, physician, family member) and present a reasonable number of medical
experts, of their own choosing and at their own expense.
HHS/CDC also agrees that access to independent judicial review is essential and assures
the public that this final rule does not affect the constitutional or statutory rights
of individual to seek
[*6915] judicial review through such traditional mechanisms as a petition for a writ of habeas
corpus under
28 U.S.C. 2241. As a Federal agency, however, HHS/CDC would lack the legal authority through regulation
to grant Federal courts with jurisdiction that they would not otherwise possess because
only Congress may expand a Federal court’s jurisdiction.
HHS/CDC received a comment from a partnership of public health legal scholars and
organizations stating that the CDC Director should not have unfettered discretion
to accept or reject the medical reviewer’s decision, but rather should only be allowed
to reject a decision based on lack of substantial evidence. HHS/CDC believes that
it would be inappropriate to mandate through regulation that the decision of a medical
reviewer (which may include an HHS or CDC employee) should displace the decision of
the CDC Director, particularly where the statute and delegation of authority have
provided otherwise.
HHS/CDC received several comments stating that a medical representative should be
appointed to anyone regardless of their ability to pay. HHS/CDC disagrees and notes
that appointment of a representative at the government’s expense without regard to
the patient’s indigence is not required. The status of “indigent” is self-reported
as HHS/CDC will not require access to an individual’s financial records. Those who
self-identify as indigent may be required to sign an affidavit or declaration under
penalty of perjury stating they meet the threshold of at least 200% of the applicable
poverty guidelines.
HHS/CDC received a comment from a non-profit organization contending that the medical
review does not comport with due process because there is no limit on the number of
reviews that may be consolidated into a single proceeding, no access to legal counsel,
no independence of the reviewer from the initial decision-maker, no confrontation
or cross-examination of witnesses, no compulsory process for obtaining evidence or
testimony, and no judicial review. This group contends that any detention that is
non-exigent should occur only based on the “informed explicit written consent” of
the patient or “utilize the existing legal procedures for involuntary commitment of
persons.”
HHS/CDC disagrees that the medical review as described and set forth in the regulations
does not comport with due process. While HHS/CDC acknowledges that there is no numerical
limit to the number of medical reviews that may be consolidated, HHS/CDC believes
that the circumstances giving rise to the need for consolidation will be exceedingly
rare and that medical reviews will generally be conducted on an individual basis.
HHS/CDC also disagrees that there is no access to legal counsel because HHS/CDC will,
consistent with principles of preventing communicable disease spread, allow persons
subject to public health orders to communicate with family and legal counsel whom
they hire at their own expense. Furthermore, as described above, the regulations have
been amended to require the appointment of both an attorney and a medical professional if the detained individual qualifies as an indigent and requests
a medical review. Individuals who do not qualify as indigent may also choose to be
represented at the medical review by an advocate (e.g., an attorney, physician, family member) and present a reasonable number of medical
experts, of their own choosing and at their own expense.
HHS/CDC further believes that reliance on internal reviewers does not violate due
process and notes that it is not unusual, for instance, for hospitals to rely on internal
decision-makers when determining whether to commit a mental health patient on an emergency
basis. The regulations, moreover, explicitly state that the medical reviewer will
not be the same individual who initially authorized the quarantine or isolation order.
We note further that the definition of both “representatives” and “medical reviewer”
would in fact allow for the appointment of non-HHS/CDC employees in these capacities
because both terms are broadly defined in terms of the professional qualifications
and not employment status of these individuals. Thus, these regulations do not prohibit
the CDC Director from appointing personnel from outside of the agency to assist in
conducting a medical review. For individuals qualifying as indigent, HHS/CDC intends,
generally, to provide independent legal counsel from outside of the agency.
HHS/CDC also clarifies that during the course of a medical review, a detained individual
will be permitted to present witnesses and question any witnesses offered by HHS/CDC.
Any “confrontation” of witnesses, however, will be conducted in a manner consistent
with principles of preventing communicable disease spread. HHS/CDC, as a Federal agency,
however lacks the legal authority to allow a detained individual to use compulsory
processes, such as a subpoena, to compel the presence of witnesses. HHS/CDC will nevertheless
make reasonable efforts to produce any HHS/CDC employees that would be critical to
a detained individual’s presentation of evidence during a medical review.
HHS/CDC also disagrees that there is no judicial review and notes that these regulations
do not impact an individual’s constitutional or statutory rights to contest their
Federal detention through such traditional mechanisms as a petition for a writ of
habeas corpus under
28 U.S.C. 2241. To the extent, however, that the commenter contends that HHS/CDC should follow legal
procedures other than those set forth through the Federal quarantine statute at
42 U.S.C. 264, we disagree. HHS/CDC notes that as a Federal agency it lacks the ability to rewrite
Federal statutes or grant Federal courts with legal jurisdiction that they do not
already possess. HHS/CDC also rejects as impractical and as insufficient to protect
public health, the notion that isolation or quarantine should only occur based upon
the consent of the subject individual.
HHS/CDC received a comment from a flight attendant union that as an important “safety
net” HHS/CDC should pay for “second medical opinions.” HHS/CDC declines to extend
payment to medical examinations beyond those required as part of a public health order,
but notes that as part of a medical review individuals may submit additional evidence
into the record concerning their health status and potential public health risk to
others.
One commenter noted language in the NPRM stating that the “medical review is not intended
to address the concerns of individuals who take issue with amenities of their confinement
. . .,” interpreting this to mean that “no provision is made for those who must use
a CPAP (continuous positive airway pressure) at night or who need orthopedic appliances,
or who have food allergies, to name a few.” In response, HHS/CDC states that, when
confinement of an individual under Federal public health authorities is needed, HHS/CDC
will ensure that such confinement will occur in a location and with necessary amenities
to ensure the health and safety of the individual, including provision for medical
or dietary requirements. Issues related to health and safety will be addressed at
the time of the issuance of the order, or as soon as HHS/CDC is made aware of them,
but are beyond the scope of the medical review which is intended to re-evaluate the
continued need for the Federal public health order based on a review of the medical
and other evidence submitted into the record.
[*6916]
HHS/CDC received a comment from a partnership of public health legal scholars and
organizations stating that it should provide for an oral hearing whenever practical.
HHS/CDC agrees that an oral hearing is appropriate and has modified the language to
state: “The medical review shall be conducted by telephone, audio or video conference,
or through other means that the medical reviewer determines in his/her discretion
are practicable for allowing the individual under quarantine, isolation, or conditional
release to participate in the medical review.”
HHS/CDC received a comment from a partnership of public health legal scholars and
organizations that the CDC Director’s written order, which constitutes final agency
action, must advise individuals of their rights to appeal to Federal court. We note
that the commenters specifically cite the Administrative Procedures Act (APA,
5 U.S.C. 704), which provides that “final agency action for which there is no other adequate remedy
in a court are subject to judicial review.” While HHS/CDC agrees that independent
judicial review of agency decisions is available, it takes no position as to whether
such reviews should occur under the APA (as suggested by the commenters) or through
other traditional mechanisms as a petition for a writ of habeas corpus under
28 U.S.C. 2241. For this reason, HHS/CDC believes that due process is satisfied by designating the
Director’s written order as “final agency action” without further speculation as to
the exact form of further legal review. However, to clarify HHS/CDC’s intended we
have added the following language to the regulatory text: “Nothing in these regulations
shall affect the constitutional or statutory rights of individuals to obtain judicial
review of their federal detention.”
Accordingly, after consideration of these comments, HHS/CDC has modified paragraph
(f) of the provisions regarding medical review of a Federal order for quarantine, isolation, or conditional release ( § § 70.16 and 71.39) to include the revised definition of “Representatives,” which
now requires HHS/CDC to appoint both a medical professional and an attorney “to assist
the individual for purposes of the medical review upon a request and certification,
under penalty of perjury, by that individual that he or she is indigent and cannot
afford a representative.”
HHS/CDC received a comment from a flight attendant union concerning whether an overlap
existed between CDC’s maintenance of administrative records relating to the issuance
of Federal public health orders and an employee’s access to exposure and medical records
under OSHA (
29 CFR 1910.1020). We note that since HHS/CDC is not a flight attendant’s employer, HHS/CDC would
not be covered by this particular OSHA standard under these circumstances. Furthermore,
because these regulations do not alter, define, or mandate the employer-employee relationship
between flight attendants and their employers, to the extent that this question seeks
input regarding an employer’s obligations under OSHA, HHS/CDC views the question as
outside the scope of the rulemaking.
HHS/CDC received a comment from a partnership of public health legal scholars and
organizations stating that the regulations should require quarterly reporting to Congress
to facilitate transparency and oversight. While CDC recognizes the additional transparency
that direct reporting of details related to quarantine activities may provide to the
public, CDC notes that historically, the issuance of Federal orders is rare (i.e., one to two orders issued per year). Thus, publication of the specifics surrounding
individual quarantine cases may raise significant privacy concerns related to the
individuals placed under federal orders.
CDC does routinely describe its practices in published Morbidity and Mortality Weekly
Reports (MMWR) when new methods, technologies, or other changes make it possible to
revise and improve programs (e.g. DNB, M&M guidance, change in air contact investigation algorithms), which all serve
to enhance transparency. Such information is also found on CDC’s Web site and publicly
available standard operating procedures.
After consideration of comments received and as further explained below, HHS/CDC has
modified the provisions regarding Administrative Records relating to a Federal order for quarantine, isolation, or conditional release ( §
§ 70.17 and 71.29) to remove paragraphs (5) regarding agreements entered into between
HHS/CDC and the individual.
HHS/CDC received many additional comments from the public concerned over whether this
regulation violates rights guaranteed by the U.S. Constitution, such as Due Process
and specifically during the medical review process. HHS/CDC disagrees that the regulations
are insufficient to protect the constitutional rights of individuals. In regard to
medical reviews, HHS/CDC asserts that allowing individuals to choose at the government’s
expense who will conduct the medical review is not required by due process and that
there is no conflict of interest in allowing the CDC Director to appoint who will
conduct the medical review on the agency’s behalf. HHS/CDC asserts, however, that
individuals will be allowed to submit relevant information, including information
provided by outside doctors or other medical specialists during the medical review.
HHS/CDC will further preserve relevant agency documents for purposes of ensuring a
competent legal review in the event that the individual seeks judicial redress of
their quarantine or isolation. As explained elsewhere, law enforcement support for
quarantine or isolation orders will generally be provided by U.S. Customs and Border
Protection, U.S. Coast Guard, or other Federal law enforcement programs, but HHS/CDC
may also accept voluntary state and local assistance in enforcing its Federal orders.
HHS/CDC received public comment expressing concern with regard to potential language
barriers experienced by foreign nationals during travel. HHS/CDC responds that it
has revised those sections of the regulations dealing with issuance of Federal orders
to require that HHS/CDC arrange for translation or interpretation services of the
Federal order as needed. In circumstances where it would be impractical to provide
a line-by-line translation of the order, HHS/CDC may take other steps to reasonably
apprise individuals of the contents of the order, for example, by arranging for oral
translation services.
One public health organization questioned the feasibility of CDC’s conducting the
mandatory reassessment or medical review of a group quarantine order within the specified
time frame. In response, HHS/CDC states that a group quarantine order would be issued
on the basis of a shared exposure for all individuals in the group; therefore, the
mandatory reassessment or medical review could be conducted based on the shared exposure,
unless certain individuals in the group were determined to be immune to the quarantinable
communicable disease in question. Part of the reassessment would include a determination
of whether the group order should be revised as individual orders.
[*6917]
HHS/CDC also received a comment that the duration of a quarantine, isolation, or conditional
release period is not adequately defined. HHS/CDC disagrees because the regulations
limit these actions to only those who would pose a public health threat, for instance,
by being in the “qualifying stage” or a quarantinable communicable disease. The “qualifying
stage” of the disease is defined as a communicable stage of the disease or a precommunicable
stage, but only if the disease would be likely to cause a public health emergency
if transmitted to other individuals. We note that HHS/CDC’s “Health Information for
International Travel” (also known as the Yellow Book) provides the public with general
guidance regarding the expected length of communicability for many quarantinable communicable
diseases. For more information, please see
http://wwwnc.cdc.gov/travel/yellowbook/2016/table-of-contents.
HHS/CDC received a comment that the qualifications of who may issue a quarantine or
isolation order are not defined leading to concerns that such orders will be issued
by non-medically trained personnel. In regard to the qualifications of who may issue
a Federal public health order, HHS/CDC notes that all orders are issued under the
authority of the CDC Director, but that in practice such determinations are made only
by personnel trained in public health and licensed to practice medicine in the United
States.
One organization requested that HHS/CDC provide notification to the appropriate embassy
if a foreign national is placed under a Federal order. In regard to non-resident foreign
nationals, HHS/CDC clarifies that it will coordinate closely with the U.S. Department
of State to ensure that all rights and obligations under the Vienna Convention on
Consular Relations and bilateral agreements will be observed. Because of the complexity
of this issue, including reliance on the interpretation of treaties and bilateral
agreements, HHS/CDC believes that it is best to ensure compliance through operational
procedures, rather than to formalize such obligations through regulatory text.
One commenter requested that HHS/CDC clarify its handling of issues relating to diplomatic
immunity. HHS/CDC recognizes that under the Vienna Convention on Diplomatic Relations,
diplomats are not liable to any form of “detention.” It is HHS/CDC’s policy to coordinate
closely with the U.S. Department of State regarding any public health issues arising
in regards to diplomats and HHS/CDC will continue to do so under these regulations.
One public health organization recommended that HHS/CDC include written notification
to individuals under public health orders of the duration that the order will be in
effect. HHS/CDC responds that it will provide information on the incubation and communicability
period of the quarantinable communicable disease, if known, but that the duration
of the public health order may depend on a variety of factors, such as demonstration
of non-infectiousness through repeated laboratory testing. Thus, HHS/CDC is unable
to provide an exact numerical limit (in terms of days or hours) that a public health
order will remain in effect.
HHS/CDC received a comment from a partnership of public health legal scholars and
organizations stating that in exigent circumstances HHS/CDC may isolate or quarantine
an individual, but should then be required to hold a mandatory due process hearing
within 48 hours before a neutral decision-maker. At the outset, HHS/CDC agrees with
the commenters that the appropriate framework for determining the adequacy of due
process procedures are the factors articulated by the Supreme Court in Matthews v. Eldridge, 424 U.S. 319 (1976). These factors include: (1) The private interest affected by
the government’s actions; (2) the risk of erroneous deprivation of such private interest
through the procedures used and the probable value, if any, of additional or substitute
procedures; and (3) the government’s interest, including the function involved and
the fiscal and administrative burden of proposed additional or substitute procedures.
Concerning the private interest at stake, HHS/CDC disagrees that this interest should
be measured solely in terms of the physical liberty of the individual, but notes that
the private interest also includes an interest in receiving medical treatment and
in not harming others, as would occur if the individual was communicable. The Federal
government’s interest, moreover, is particularly strong because it is not simply guarding
the welfare of a single individual or even a small group of individuals, but rather
protecting the public at large against the spread of a quarantinable communicable
disease. Most importantly, HHS/CDC believes that mandatory administrative hearings
are unlikely to significantly guard against erroneous deprivations. Unlike subjective
determinations of behavior which typically form the basis of a mental health “civil
commitment,” isolation and quarantine decisions are based on objective criteria such
as manifestations of physical illness or laboratory test results. Thus, weighing these
factors, HHS/CDC disagrees that due process requires it to adopt a system of mandatory
administrative hearings in the absence of the individual requesting a medical review.
Regarding the use of a “neutral” decision maker, HHS/CDC restates that the definition
of both “representatives” and “medical reviewer” would in fact allow for the appointment
of non-HHS/CDC employees in these capacities. The regulations, moreover, explicitly
state that the medical reviewer will not be the same individual who initially authorized
the quarantine or isolation order. Accordingly, HHS/CDC has determined that the procedures
it has adopted for medical reviews comport with due process.
Several people commented on the private nature of the doctor-patient relationship.
HHS/CDC appreciates the opportunity to respond to this concern. HHS/CDC is charged
with protecting the health of the public. At times, this requires obtaining private
information about people’s health or exposure history and taking certain actions to
protect others from becoming sick with a communicable disease. HHS/CDC works closely
with State and local health departments to ensure that ill people detained or isolated
under Federal orders receive appropriate care and treatment. HHS/CDC is also bound
by the
Privacy Act to protect personally identifiable information collected and maintained under that
Act. For a more detailed explanation of how such information is protected, please
see
http://www.cdc.gov/sornnotice/09-20-0171.htm. For information on the retention and maintenance of such records, please see
https://www.archives.gov/records-mgmt/rcs.
HHS/CDC received a comment from a professor of public health law and ethics stating
that HHS/CDC should address how the HIPAA Privacy Rule,
Americans with Disabilities Act (ADA), and
Administrative Procedure Act (APA) counterbalance the powers set forth in the proposal and reflect “appropriate
social distancing practices.” The commenter did not highlight which specific provisions
of these laws HHS/CDC should address or the relationship that these laws have to social
distancing. Notwithstanding, HHS/CDC may generally state that these regulations will
be carried out consistent with Federal law.
We note that HHS is a hybrid entity under HIPAA, but only those parts of the Department
that have been [*6918] determined to be health care components are subject to the HIPAA Privacy Rule. CDC
is generally not a health care component treated as a “covered entity” under the HIPAA
Privacy Rule. However, certain specific offices of HHS, CDC, and the National Institute
for Occupational Safety and Health (NIOSH) performing activities related to the World
Trade Center Health Program are considered health care components of HHS and must
comply with HIPAA and the Privacy Rule.
CDC most often acts as a public health authority under the HIPAA Privacy Rule. During
the course of a public health investigation it may seek the support of a covered entity,
such as a hospital or private physician. The HIPAA Privacy Rule permits the disclosure
of public health information to public health authorities, such as the CDC, and their
authorized agents for public health purposes including but not limited to public health
surveillance, investigations, and interventions. More information concerning the HIPAA
Privacy Rule may be found here:
http://www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm.
Similarly, we note that this final rule while formalizing administrative policies
and practices, does not affect the rights of individuals under the ADA or APA, which
are statutes enacted by Congress. One commenter opined that collection of contact
information as part of public health prevention measures and maintenance of administrative
records raise privacy concerns and that HHS/CDC should consider “super-enhanced privacy
protections” consistent with the Model State Public Health
Privacy Act of 1999. HHS/CDC disagrees. As a Federal agency, HHS/CDC must abide by the laws established
by Congress for the protection of records, specifically the
Privacy Act of 1974,
5 U.S.C. 552. On December 13, 2007, HHS/CDC published a system of records notice (
72 FR 70867) under the
Privacy Act describing, among other things, safeguards for preventing the unauthorized use of
information collected from travelers. HHS/CDC will make disclosures from this system
only with the consent of the subject individual, in accordance with routine uses published
in its system notice, or in accordance with an applicable exception under the
Privacy Act.
HHS/CDC received several comments relating to payment for medical expenses. One commenter
stated that HHS/CDC should assume payment for all related medical expenses, housing
costs, and other necessities for individuals or groups subject to deprivations of
liberty and that it is “ethically unfair” for HHS/CDC to be the “payer of last resort.”
Another commenter stated that “CDC must guarantee financial help after third party
payments are exhausted.” While HHS/CDC acknowledges that it has an ethical, moral,
and legal obligation to provide care and treatment for individuals under a Federal
quarantine or isolation order, HHS/CDC disagrees that it is “ethically unfair” to
excuse a medical insurer or other entity with a contractual obligation from paying
for medical expenses. Accordingly, HHS/CDC has determined that it is appropriate for
it to maintain and affirm its status as a “payer of last resort.”
Two public health organizations asked whether nonmedical costs such as training of
staff, replenishing of personal protective equipment, managing and disposing of biological
waste and contaminated supplies, etc., are also subject to HHS/CDC payment authorization.
While the costs of care and treatment of individual patients under Federal public
health orders are authorized by this rule, these additional costs to the extent that
they are unrelated to the individual patient’s treatment and care would not be covered
by this rule.
HHS/CDC received a comment suggesting that the regulations allow for charging detainees
the medical and hospital costs of nonconsensual treatment. HHS/CDC disagrees and first,
clarifies that these regulations do not authorize compulsory medical treatment. HHS/CDC
further acknowledges that constitutional principles and medical ethics require that
those detained under isolation or quarantine have access to adequate nourishment,
appropriate accommodation, and medical treatment. However, HHS/CDC has determined
that its obligation to pay for medical care and treatment should be secondary to the
obligation of any third party, such as a medical insurer that may have a pre-existing
contractual obligation with the patient to pay for hospital expenses. Accordingly,
HHS/CDC declines to make any changes to the provisions authorizing payment for medical
care and treatment.
A flight attendant union commented that HHS/CDC should pay for any outside costs that
the flight attendant would normally incur relating to medical treatment, e.g., copayments, deductibles. HHS/CDC declines this suggestion and notes that while it
is not HHS/CDC’s intent to unduly burden individuals with the costs of their own isolation
or quarantine, payment for expenses will be made consistent with constitutional and
ethical obligations to provide for the basic necessities, e.g., food, medical treatment, for those subject to such public health orders. Furthermore,
these regulations do not alter, define, or modify the contractual relationship between
insurance companies and the insured.
After consideration of these comments, HHS/CDC has finalized the provisions relating
to payment for care and treatment ( § § 70.13 and 71.30) as proposed.
HHS/CDC received comments relating to the intention and use of agreements. Commenters
worried that such “agreements” may be coerced, and individuals would be compelled
to submit to involuntary testing or “research projects.” One commenter stated that
the definition of agreement is circular and confusing because the word “agreement”
appears in the definition. This commenter also suggested that what HHS/CDC proposes
should more aptly be labeled as an “Affidavit” or “Affirmation” because the definition
as proposed by HHS/CDC lacks bilateral obligations on both parties.
Due to the number of public comments received expressing confusion over this public
health measure, HHS/CDC has removed the provisions on Agreements (70.18 and 71.40), and modified other provisions of the final rule (70.1, 71.1(b),
and 70.5) to remove references to “agreements.”
Many commenters expressed concern over the penalties provisions contained within the
proposed regulation. Specifically, one association objected to “CDC’s proposed increase
in penalties.” Another stated that “CDC is not qualified to decide upon the punishment.”
HHS/CDC takes this time to better explain that the penalties listed in today’s final
rule, which have been codified as proposed, are set forth by Congress via statutory
language and codified into regulation to reflect current practice. This regulation
serves to notify the public of the existing statutory penalties for violation of quarantine
regulations, which HHS/CDC has no authority to change.
One organization requested that language be added to rules regarding the issuance
of penalties if an employer provides an “unsafe work or unhealthful working condition.”
HHS/CDC responds that such penalties are beyond the scope of this rule and refers
[*6919] the commenter to regulations of the Occupational Safety and Health Administration.
HHS/CDC received a comment from a flight attendant union regarding criminal penalties
stating that HHS/CDC should provide further clarification as to what constitutes a
violation and clarify that flight attendants who act in accordance with their company’s
practices, policies, or procedures should not be held criminally liable. In response,
HHS/CDC notes that while the text of the regulation is being updated, these regulations
do not increase the criminal penalties that may be imposed for violations of quarantine
regulations or alter the manner in which liability may be assessed. Rather, these
regulations serve to inform the public of the criminal penalties that currently exist
in statute (
42 U.S.C. 271 and
18 U.S.C. 3571). Furthermore, HHS/CDC clarifies that criminal penalties, if any, would be assessed
by a court of law based on an indictment or information filed by an Assistant U.S.
Attorney based on individualized facts and circumstances, and would not be determined
administratively by the CDC.
HHS/CDC offers the following explanation to inform the public regarding this section.
As prescribed in section 368 (
42 U.S.C. 271) and under
18 U.S.C. 3559 and
3571(c), criminal sanctions exist for violating regulations enacted under sections 361 and
362 (
42 U.S.C. 264 and
265).
18 U.S.C. 3559 defines an offense (not otherwise classified by letter grade) as a “Class A misdemeanor”
if the maximum term of imprisonment is “one year or less but more than six months.”
18 U.S.C. 3571 provides that individuals found guilty of an offense may be sentenced to a fine.
Specifically, an individual may be fined “not more than the greatest of”—(1) the amount
specified in the law setting forth the offense; or (2) for a misdemeanor resulting
in death, not more than $250,000; or (3) for a Class A misdemeanor that does not result
in death, not more than $100,000. Similarly, an organization, found guilty of an offense
may be fined “not more than the greatest of”—(1) the amount specified in the law setting
forth the offense; or (2) for a misdemeanor resulting in a death, not more than $500,000;
or (3) for a Class A misdemeanor that does not result in death, not more than $200,000.
42 U.S.C. 271 sets forth statutory penalties of up to 1 year in jail and a fine of $1,000. Therefore,
it is classified as a Class A misdemeanor under
18 U.S.C. 3559. Because the alternate fines set forth under
18 U.S.C. 3571 are greater than the $1,000 set forth under
42 U.S.C. 271 (which sets a maximum penalty of not more than $1,000 or one year of jail, or both
for violation of quarantine laws), and because
42 U.S.C. 271 does not exempt its lower penalties from
18 U.S.C. 3571(e), HHS/CDC has chosen to codify the greater penalties of
18 U.S.C. 3571(b)(5) and (c)(5) and to remove the lower penalties as stated in
42 CFR 71.2 from the regulation.
After consideration of these comments, HHS/CDC has finalized the provisions relating
to Penalties (70.18 and 71.2) as proposed. Penalties has been moved to section 70.18, since proposed 70.18 Agreements has been removed from this final rule.
Within the analysis published with the NPRM, HHS/CDC solicited public comment regarding
the cost and benefit estimates for airlines and vessel operators associated with improved
provision of traveler contact data. While HHS/CDC received support for the data collection
from two public health associations, HHS/CDC received a comment from industry who
misread the proposals to mean that aircraft operators would be required to develop
new capacity and processes to capture and store a comprehensive set of sensitive data,
archive this data, and then provide it to CDC.
HHS/CDC restates and clarifies that today’s final rule does not impose any new burdens
upon the airline industry but rather, codifies the current practice of receiving a
passenger manifest order (if needed, as CDC currently collects passenger information
from CBP via APIS and PNR) and providing HHS/CDC with any data in an airline’s possession.
This regulatory impact analysis has been revised to clarify that the rule does not
require an airline to solicit or store additional data. Therefore, HHS/CDC does not
expect that formalizing its current data collection practices will increase costs.
Neither airlines nor U.S. Customs and Border Protection (CBP) will need to develop
new data systems nor will travelers need to provide data as part of the “check in
process.”
The same industry organization also commented that they have been complying effectively
with the existing requirements, but have, on occasion found it difficult to locate,
extract, compile, format and transmit available information within the timeframe specified
in orders from HHS/CDC. They note that delays sometimes arise because the manifest
order may contain incorrect flight or passenger information. The discussion in the
regulatory impact analysis section has been revised to note that delays in compliance
with manifest order requirements may result from HHS/CDC having incorrect traveler
information in the manifest order.
The same industry organization also reports that all of the data available to them
related to passengers are currently transmitted as Advance Passenger Information System
(APIS), and potentially under Passenger Name Record (PNR), data to the Department
of Homeland Security (DHS) and that there is no reason to burden airlines with an
order for passenger data. HHS/CDC recognizes that industry does submit certain passenger
data to DHS and it is not our intent to burden industry with duplicative requirements,
but rather to effectively and efficiently protect public health. In the experience
of the HHS/CDC, queries from APIS/PNR rarely result in full sets of contact information
(i.e. the record includes all five additional data fields as outlined in the final rule).
The data fields that are most commonly missing from the records are email addresses
(missing 90 percent of the time), secondary phone number (missing 90 percent of the
time), and street addresses (missing or insufficient for public health contact tracing
up to 50 percent of the time). These data elements are vital to a contact tracing
investigation. In looking at a random sample of 20% of the compiled international
air travel manifests for 2015, those including a compiled data set from NTC and the
airlines, 100% were missing at least one of the 5 data fields. Email address and secondary
phone number were among those most frequently missing. For context, there were approximately
760,000 scheduled flights that arrived into the United States in 2015. In 2015, CDC
issued passenger manifest requests for 64 international flights arriving into the
United States. As noted in the RIA of the final rule, from 2010 to 2015, CDC conducted
an average of 77 contact investigations per year involving arriving international
flights.
Airlines are contacted for the majority of contact investigations using a manifest
order document. At a minimum, CDC needs to confirm the ill traveler was on the flight
and where the individual sat in relation to other travelers to determine risk of exposure.
In CDC’s experience the following has been true:
• Only airlines can quickly and efficiently produce a partial manifest targeting affected
rows;
• only airlines can confirm identity of “babes in arms” and their co-travelers (Parent);
this is important for measles cases;
[*6920]
• only airlines can quickly confirm whether an individual actually flew (in instances
where individuals deplane and do not re-board during a layover); and
• only airlines can confirm a plane’s configuration if there is a question with the
provided row numbers. Different aircraft have different seating arrangements depending
on carrier and layout. It is important to know if a certain seat is separated by a
bulkhead or is a window seat.
In addition, HHS/CDC only requires a partial manifest, e.g. 5 rows for travelers with infectious tuberculosis, so that NTC and HHS/CDC staff
can limit the investigation to only those passengers at risk and supplement/cross
reference with APIS and PNR data. If a partial manifest is not available from the
airlines, then each passenger record must be researched individually to find a seat
number, and then the configuration of an entire plane must be populated to determine
where the index case sat in relation to other at-risk passengers. For large flights
from Asia, this can pose a tremendous burden to NTC and CDC staff while slowing the
ability of CDC to provide important contact information to state and local health
departments. Manually populating multiple 300+ person flights is not feasible in a
timely manner.
As part of its plan for retrospective analysis under E.O. 13563, HHS/CDC intends to
synthesize, analyze, and report within the next two years on strategies to reduce
duplication of the collection of passenger/crew manifest information in coordination
with DHS/CBP. The report will include any recommendations (
e.g., IT systems improvements to facilitate enhanced search capabilities of passenger data,
increased efficiency to relay passenger data, improvements to the existing CDC-CBP
MOU) to ensure that the collection of passenger or crew manifest information do not
unduly burden airlines, vessels, and other affected entities. HHS/CDC intends to seek
public comment on the report and any recommendations regarding the costs and benefits
of activities implemented in
42 CFR parts 71.4 and
71.5. Estimates of both costs and benefits in the NPRM regulatory impact analysis were
not very large because HHS/CDC is not implementing a new data collection requirement.
The regulatory impact analysis for the final rule has been revised to reflect that
HHS/CDC will work with CBP to search for responsive data to avoid duplicative data
requirements. Estimates of costs in the revised regulatory impact analysis have not
been revised because the airline industry did not provide any new information regarding
costs to search for responsive data when receiving manifest orders. The benefit estimate
has been revised and is lower than the estimate for the NPRM to indicate that the
airlines may not have any more contact data than is already provided in APIS or PNR
data submitted to DHS.
HHS/CDC received a number of comments from the general public that compared the relatively
small number of measles cases in any given year to the total numbers of vaccine-associated
adverse events and health department spending to contain measles outbreaks. Based
on this comparison, commenters believed that HHS/CDC and health departments spend
too much money on communicable disease control and that resources would be better
allocated to other activities. Some commenters suggested that the costs of these adverse
events should be included in a
Small Business Regulatory Enforcement Fairness Act analysis. In general, this type of analysis is outside the scope of this regulatory
impact analysis because this final rule does not require measles vaccination. HHS/CDC’s
recommended vaccine schedule will not be affected by this final rule. Although HHS/CDC
recommends that health departments offer measles vaccine to non-immune individuals
exposed during travel, measles is not a quarantinable communicable disease and this
final rule does not require any individual to receive a measles vaccine. Because health
departments offer measles vaccines to exposed, non-immune travelers, HHS/CDC estimates
that the final rule will only result in a small number (6) of additional measles vaccines.
The costs of procuring and administering these vaccines is included in the analysis.
As noted in the regulatory impact analysis, there are only 564 travelers exposed to
measles during international travel in a given year. Most of these travelers will
already have immunity to measles and the final rule is only expected to have a small
impact on the ability of health departments to contact travelers. The total costs
of all measles vaccine-associated adverse events is outside the scope of the analysis
for this final rule as mentioned above.
One commenter suggested that the cost estimates for the NPRM were too low because
the analysis did not account for reduced willingness to travel if vaccines against
measles and other communicable diseases are required to travel. HHS/CDC disagrees
with this suggestion because vaccination is not a requirement in this final rule.
HHS/CDC has on occasion requested that DHS/TSA restrict interstate or international
air travel for people known to be infectious with measles who were noncompliant with
public health recommendations not to travel. However, HHS/CDC does not recommend restricting
the air travel of persons who have not received the measles vaccine.
One commenter questioned whether the estimated value of statistical life ($9.4 million)
should be multiplied by the total number of measles vaccine-associated adverse events
in the United States. HHS/CDC appreciates this thoughtful comment. This would result
in a larger estimate in the cost of measles vaccine-associated adverse events. However,
this is not a correct usage of the value of statistical life, which should only be
multiplied by an estimated number of deaths. The regulatory impact analysis has been
revised to better explain this distinction.
Another commenter suggested that public health department measles response costs were
overestimated by using a model-based approach rather than estimating the cost of hiring
of additional staff to deal with measles outbreaks. HHS/CDC addressed the comment
in the regulatory impact analysis by clarifying that the analysis is a published model-based
analysis and that the cost estimate is based on the opportunity cost of public health
personnel and is not based on the cost of hiring additional staff.
HHS/CDC received comments from the airline industry indicating that the definition
of ill person under 71.1 does align with Note 1 to Standard 8.15 of ICAO’s Annex 9
to the Convention on International Civil Aviation. HHS/CDC also received comments
from the airline industry regarding the change to the definition of ill person under
70.1 for interstate flights contending that these changes would increase costs. Specifically,
the airline industry reported that not only does the expansion of the definition of
ill person place a greater burden on airline staff, the ambiguity of that definition amplifies
the burden or at least raises questions as to the particular obligations of the flight
crew to determine if someone is an “ill person.” Moreover, the airline industry wanted
to know whether flight crews have an obligation to conduct a physical examination
of the passenger to determine fever. The airline industry also noted that under the
OSHA blood borne pathogens standard, employers are prohibited from exposing crewmembers
to blood or other potentially infectious materials. The airline industry also questioned
whether the fever-related illness [*6921] reporting in the proposal would require that all carriers have the equipment (thermometers)
onboard to determine fever. The proposal, as noted, has two other ways to identify
fever (warm to touch or history of fever) which the airline industry wanted to ensure
would remain viable options within the final rule.
HHS/CDC notes that there is no expectation that flight crews should perform physical
examinations as part of illness reporting. HHS/CDC also notes that the non-thermometer
(warm to touch or history of fever) remain in the final rule. Regarding the potential
for increased costs associated with the change in illness reporting for interstate
flights, HHS/CDC notes that the current illness reporting requirements for interstate
travel appear in
42 CFR 70.4 and state that “The master of any vessel or person in charge of any conveyance engaged
in interstate traffic, on which a case or suspected case of a communicable disease
develops shall, as soon as practicable, notify the local health authority at the next
port of call, station, or stop, and shall take such measures to prevent the spread
of the disease as the local health authority directs.” Communicable disease is defined
in current
42 CFR 70.1 as “illnesses due to infectious agents or their toxic products, which may be transmitted
from a reservoir to a susceptible host either directly as from an infected person
or animal or indirectly through an intermediate plant or animal host, vector, or the
inanimate environment.”
The changes in this final rule will not result in substantially increased costs because
airlines would either: (1) Be complying with the current regulatory requirement and
report all cases or suspected cases of communicable disease to local health departments;
or (2) report illnesses according to HHS/CDC guidance available at
http://www.cdc.gov/quarantine/air/reporting-deaths-illness/guidance-reporting-onboard-deaths-illnesses.html, which is codified in this final rule. HHS/CDC notes that changes in this final rule
align the symptoms requested for international and interstate illness reporting. In
addition, according to guidance, reports received by HHS/CDC would be considered sufficient
to satisfy the requirement to report to local health departments because HHS/CDC will
coordinate response activities with the local health department after receiving an
illness report. In response to these comments, HHS/CDC increased the expected number
of illness reports in the upper bound analysis regulatory impact analysis for the
final rule. This upper bound analysis finds that a 100% increase in info-only reports
and 50% increase in reports requiring response would result in a marginal cost of
$20,573 for airlines and vessel operators. This cost is negligible compared to the
annual revenue of the international air and maritime travel markets. HHS/CDC also
received a comment to include the cost of training for illness reporting in the regulatory
impact analysis. HHS/CDC notes that illness reporting is already required under existing
regulations and the changes in this final rule more closely align with ICAO guidance
for illness reporting for international flights and represent a reduction in burden
for interstate flights, where reporting of all cases or suspected cases of communicable
diseases is required. HHS/CDC added an estimate of training costs to the upper bound
cost analysis for airlines (an annualized $356,000 per year).
HHS/CDC received a comment from a local health department concerning the rationale
for reporting all illnesses and deaths that occur on interstate flights. This health
department asked whether evaluating illnesses and deaths that occur on interstate
flights may lead to an increase in costs for State and local health departments. HHS/CDC
does not anticipate an increase in costs for State and local health departments because
evaluating illnesses and deaths occurring on interstate flights is consistent with
existing HHS/CDC guidance and represents a less restrictive alternative compared to
the existing reporting requirement in
42 CFR 70.4. Furthermore, the costs to State and local health departments may decrease if HHS/CDC
is able to filter out reports that do not require a public health response, which
airlines would have previously reported directly to the health departments under
42 CFR 70.4. If there is an increase in the number of illness reports requiring a public health
response, HHS/CDC believes the costs to health departments may decrease if the health
department is notified earlier.
A public health research center questioned the value of nonmedical personnel being
able to differentiate Ebola, Middle East respiratory syndrome (MERS) or measles from
other medical issues. HHS/CDC appreciates the concern and notes that the final rule
aligns the illness reporting requirement with international guidelines and represents
a reduced burden for illness reporting on interstate flights compared to current regulatory
language as mentioned above. The intent of illness reporting is not to diagnose disease
during flight, but rather to identify a limited number of instances in which it would
be advantageous to follow up with ill travelers for an assessment upon disembarkation.
The current numbers of illness reports received are summarized in the regulatory impact
analysis and the number of reports is not expected to increase significantly because
the regulatory text will better align with publically available HHS/CDC guidance.
A number of comments from the public questioned whether there would be a huge cost
resulting from the broad definition of ill person. These commenters expressed concern that misdiagnosis by non-medically trained personnel
would lead to reduced travel based on the public’s fear of being wrongly detained
by public health officials. HHS/CDC notes that illness reporting is already required
for both interstate and international travel. We note that travelers are not placed
under public health orders simply as a result of an illness report. Rather, orders
are issued only if a licensed medical officer based on a public health risk assessment
has sufficient reason to believe that the individual is infected with a quarantinable
communicable disease. In addition, the new definition is consistent with existing
international guidelines and HHS/CDC guidance. Thus, HHS/CDC does not believe the
changes to illness reporting will result in a large burden to the general public.
The cost analysis in the regulatory impact analysis has been updated to include the
cost to travelers involved in public health follow-up after an illness report.
One commenter opposed the rule because of a perceived negative economic and/or social
impact upon individuals placed under a public health order. Regarding the social impact
of the individual who may be ostracized, HHS/CDC notes that public health measures
such as quarantine and isolation are not new concepts or practices, HHS/CDC has been
implementing these measures to protect public health for many years. We reemphasize
that one compelling reason for the publication of this final rule is to make “quarantine”
and “isolation” better understood by the public so that these terms, its purposes,
and meanings become more familiar and thereby decrease public anxiety over these important
protections. For the same reason, HHS/CDC does not believe the provisions in the final
rule will increase or decrease the cost of isolation or quarantine. HHS/CDC does provide
an estimate of traveler cost in the sections describing Ebola entry enhanced risk
assessment and management and illness [*6922] reports in the regulatory impact analysis.
One commenter suggested that the costs incurred by airlines would be passed along
to the general U.S. population purchasing tickets for air travel. HHS/CDC concurs
and mentions this possibility in the regulatory impact analysis. However, changes
included in this final rule are a codification of a current practice and estimated
total costs are only $11,000 to $431,000 per year. Thus, significant changes in ticket
prices are not expected.
One commenter suggested that changes in infectious disease caseloads would not result
in cost savings to public health agencies or individuals because there is already
a public health workforce in place. HHS/CDC calculates such costs based on the opportunity
cost of public health staff under the presumption that such staff would be involved
in other productive activities if not spending time addressing outbreaks.
HHS/CDC solicited comment from the public regarding potential public willingness to
pay to be contacted in the event of an exposure to a communicable disease during travel.
This was done to help estimate the potential benefit to the public of HHS/CDC’s efforts
to work with health departments to contact travelers exposed to meningococcal disease,
viral hemorrhagic fevers, MERS or other severe acute respiratory syndromes, measles,
and tuberculosis, among other diseases. HHS/CDC received a number of comments from
several individuals that they believe public health measures to mitigate measles transmission
are unnecessary. Some individuals also noted that Ebola and MERS cases in the United
States have not led to widespread transmission. These commenters either indicated
or inferred that they would be unwilling to pay to be informed of potential communicable
disease exposures during travel. The discussion in the regulatory impact analysis
has been updated to incorporate this feedback.
HHS/CDC solicited public comment on willingness to pay to reduce Ebola risk in the
United States to near zero if another international outbreak of Ebola with widespread
transmission occurs in the future. HHS/CDC received comments from an organization
representing flight attendants indicating that they believe it is in the public interest
to reduce Ebola risk in the United States to near zero in the event of a future outbreak.
They indicated that there is no reason to believe that achieving this objective would
require unsustainable levels of funding. HHS/CDC incorporated this comment regarding
public willingness to pay in the regulatory impact analysis.
HHS/CDC also received comments from several individuals regarding the high cost of
the measures taken to reduce the risk of Ebola transmission in the United States during
the 2014-2016 Ebola epidemic in West Africa. Several of these commenters indicated
they had zero willingness to pay for future public health measures in the event of
a large Ebola outbreak.
Many commenters stressed the need to reassess whether to implement such activities
in the event of a future Ebola outbreak. An example of such comments is provided by
a research center studying international response efforts to emerging infectious disease
threats, who noted that despite 99% complete active monitoring by health departments,
there was no evidence of incident Ebola cases among individuals traveling from Ebola-affected
countries. This does not include the two incident cases that preceded active monitoring.
The commenters state that given this evidence it is not advisable for HHS/CDC to recommend
active monitoring in the event of future Ebola outbreaks.
In addition, a public health research center cautioned against extrapolating costs
and benefits calculation methods for measles and tuberculosis to Ebola, MERS, and
other rare diseases. The research center further noted that countermeasures for Ebola
and MERS do not exist (other than isolation and quarantine). They suggest that this
would limit the effectiveness of point of entry measures. These researchers also point
to the fact that transmission of Ebola and MERS has not occurred during air travel.
They noted that point of entry risk assessment programs may increase anxiety (and
costs) if cases are detected in the community after the implementation of point of
entry measures. Finally, the research center noted that the costs for State and local
health departments to actively monitor all arriving travelers for 21 days were not
included in the analysis.
In response to these comments, HHS/CDC concurs that it would not be wise to directly
extrapolate approaches for measles and tuberculosis to rare diseases and has tried
to provide as much information as possible around the decision to implement the Ebola
risk assessment program and recommendations for active monitoring. HHS/CDC did not
simply extrapolate the analysis for measles and tuberculosis to Ebola.
HHS/CDC does not have data on State and local spending to achieve the objective of
the 21-day active monitoring program and concedes that the cost of active monitoring
would likely exceed the costs incurred at the airports. However, HHS/CDC did provide
an estimate of total Federal spending for both domestic and international efforts
to attempt to quantify the cost of these efforts. Federal money was used to support
State/local surveillance efforts. Federal money was also used to support improvements
in laboratory capacity by States and hospital infection control efforts, which should
have benefits beyond the 2014-2016 Ebola epidemic. In addition, Federal funding supported
research into potential Ebola vaccines and medicines. The cost for the Ebola enhanced
entry risk assessment program was just a portion of these costs and HHS/CDC acknowledges
that risk assessment program at airports by itself would have limited potential to
reduce risk. However, HHS/CDC also notes that the costs of Ebola entry risk assessment
at points of entry included efforts to (1) stratify travelers by risk level so that
health departments could focus more intense monitoring efforts on travelers at higher
risk and (2) educate travelers on Ebola risk factors and symptoms and provide informational
materials, a thermometer, and a telephone to all travelers to improve compliance with
active monitoring efforts. This led to a higher cost, but more effective program relative
to an alternative in which travelers would only be screened once at the airport, such
as occurred in other countries implementing screening programs during the 2003 Severe
Acute Respiratory Syndrome (SARS) epidemic.
HHS/CDC believes that the risk of Ebola infection in the U.S. population was potentially
reduced because of the combination of measures to protect against Ebola transmission
in the United States, including risk assessment at ports of entry. HHS/CDC acknowledges
the risk was probably very low in the absence of domestic activities.
HHS/CDC further notes that it recommended active monitoring of travelers as a less
restrictive alternative to more stringent measures such as quarantines that were being
demanded by some members of the public. Widespread implementation of quarantine, particularly
for healthcare workers crucial to the response efforts in West Africa and the United
States, would have greatly hampered outbreak control measures by providing a strong
disincentive to healthcare workers participating in the response.
To estimate the potential benefits of the Ebola risk assessment program at ports of
entry, HHS/CDC provided a cost comparison of the incident Ebola cases [*6923] that occurred in Texas compared to New York to estimate the difference in costs between
an Ebola case that was detected quickly and treated in a pre-selected hospital identified
to be capable of Ebola treatment in comparison to an Ebola infection that was not
initially suspected to be Ebola leading to community exposures and hospital exposures
in a hospital that was not a pre-selected hospital capable of Ebola treatment.
HHS/CDC also examined the recent MERS outbreak in South Korea to demonstrate that
even relatively small outbreaks of rare diseases such as MERS and Ebola can have large
economic costs despite a relatively small number of cases and deaths. HHS/CDC found
that the number of international travelers (non-Korean citizens traveling to South
Korea) decreased by 40-50% during the peak months of the 2015 MERS outbreak. HHS/CDC
further notes that these declines in travel occurred in the absence of widespread
travel restrictions. The costs incurred by South Korea during the outbreak were used
to demonstrate the potential costs of a larger Ebola outbreak in the United States.
Given the evidence from the programs implemented to mitigate risk during the 2014-16
Ebola epidemic, i.e., the small number of international air travelers from countries with widespread Ebola
transmission that later developed Ebola and the very limited risk of transmission
by asymptomatic individuals with Ebola infection, HHS/CDC may not elect to implement
an Ebola entry risk assessment program in the event of a future outbreak or to recommend
21-day active monitoring of travelers from countries with widespread transmission.
HHS/CDC emphasizes that it will continue to consider cost and work with multiple U.S.
government agencies, as well as with airport authorities and health departments in
U.S. States and territories, to apply the latest evidence to future decision-making.
In addition, HHS/CDC will try to employ the least restrictive measures to achieve
public health objectives. HHS/CDC notes that, during the period that the Ebola entry
risk assessment and monitoring program was in effect, only 0.08% (29/38,344) of travelers
assessed at U.S. airports were recommended for medical evaluation at hospitals and
that no Federal quarantine or isolation orders were issued during the epidemic, although
some States did issue such orders under their own authorities. These considerations
have been added to the regulatory impact analysis in the final rule. Since this analysis
concerns a codification of existing authorities, this analysis has been moved to a
separate appendix after incorporating public feedback.
A number of commenters suggested that HHS/CDC did not include the cost for people
participating in the Ebola enhanced risk assessment program. However, HHS/CDC did
provide such an analysis of these costs. One public commenter suggested that the psychological
cost of quarantine should be considered in the economic impact analysis. Although
HHS/CDC generally concurs with the idea of accounting for all of the costs associated
with time spent in quarantine, HHS/CDC’s authority to issue quarantine orders will
not change with the publication of this final rule. Thus, this final rule does not
incur new psychological costs for persons under quarantine orders.
HHS/CDC notes the opportunity costs for persons undergoing risk assessment at airports
and/or evaluation at hospitals during the 2014-16 Ebola entry risk assessment and
management program. HHS/CDC estimates their opportunity costs based on average wage
rates, but did not have additional data to estimate a marginal psychological cost.
Opportunity costs were also estimated for a more restrictive option compared to the
Ebola entry risk assessment and management program, i.e. a suspension of entry for 21 days after having been in an Ebola-affected country.
One commenter suggested that this rulemaking does not represent the “least burden
on society” because HHS/CDC has failed to clearly identify a “compelling public need”
for the rule. HHS/CDC appreciates the comment and responds that the regulatory impact
analysis cites a specific market failure addressed by this final rule. The market
failure is that the costs associated with the spread of communicable diseases impacts
the entire U.S. population, not just the group of persons currently infected with
communicable diseases. Since this final rule is primarily implementing current practice,
HHS/CDC does not anticipate major new benefits or costs.
One commenter stated that the cost/benefit analyses was very vague, meaning that there
is no accountability or way to measure whether or not the final rule will achieve
its intended result of preventing the spread of quarantinable communicable diseases
via travel, which the commenter stated was already an extremely low risk. HHS/CDC
concurs that there is uncertainty in the regulatory impact analysis. However, HHS/CDC
has tried to indicate that one of the reasons for this uncertainty is that this final
rule is primarily implementing current practice. Thus, where possible, HHS/CDC tried
to provide data on the current burden of the provisions that are being updated in
this final rule. HHS/CDC does not expect any major changes in practice as a result
of this final rule.
One commenter suggests that the cost/benefit analyses was confusing because quarantinable
and non-quarantinable diseases were not clearly identified. HHS/CDC appreciates this
feedback and has updated the analyses to more clearly differentiate quarantinable
and non-quarantinable diseases.
One commenter suggested that HHS/CDC took an unnecessarily extreme position in analyzing
an alternative of removing all enforcement of current regulations. HHS/CDC used this
as an alternative because this final rule is a codification of current practice and
does not impose new regulatory burdens.
HHS/CDC published notices related to modifications and a new information collection
in the Notice of Proposed Rulemaking. Those information collections are as follows:
(1) Foreign Quarantine Regulations (
42 CFR part 71) (OMB Control No. 0920-0134)—Nonmaterial/non-substantive change—National Center for
Emerging, and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).
(2) Restrictions on Interstate Travel of Persons (
42 CFR part 70) (OMB Control No. 0920-0488)—Nonmaterial/non-substantive change—National Center for
Emerging, and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).
(3) Airline and Vessel and Traveler Information Collection (
42 CFR part 71)—New Information Collection Request—National Center for Emerging, and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
One commenter stated that there are no estimates of additional information collection
requirements resulting in a clear violation of the Paperwork Reduction Act. The commenter
further stated that requesting information when HHS/CDC has no idea of the impact
is not a well thought out or planned rulemaking. This commenter further questioned
the value of providing comment when the agency purportedly has no idea what additional
burden it is imposing on the public. HHS/CDC disagrees with these assessments.
The focus of the final rule is to codify current practices and to update currently
approved information collections to better align with operational procedures and other
[*6924] industry guidance related to illness reporting on aircraft and vessels. Those information
collections are currently approved under OMB control numbers 0920-0134 (Foreign Quarantine
Regulations), 0920-0488 (Restrictions on Interstate Travel of Persons), and the new
information collection request Airline and Vessel and Traveler Information Collection
(
42 CFR part 71), which is currently pending OMB approval. The estimates of the burden provided in
the Paperwork Reduction Act section of the NPRM were based on previous experience
with particular information collections solicited or required from the public or industry
in the past. In some cases, larger estimates of the burden to account for an increased
number of reports to HHS/CDC during disease outbreaks or public health emergencies
were included. There are no information collections requirements that are wholly new,
unreasonably burdensome, or outside the scope of historical HHS/CDC practices implemented
to prevent the introduction or spread of communicable disease into or within the United
States.
Another commenter suggested that training in recognizing ill travelers is a burden
that was not adequately considered. HHS/CDC disagrees because it does not mandate
specific training for recognition of ill travelers. HHS/CDC is seeking to better align
the ill person definition with the ICAO standard and thus is not the only organization
that has this requirement. HHS/CDC provides specific guidance for how to recognize
ill travelers and report to HHS/CDC on its Web site. HHS/CDC also believes this training
is most likely already part of the training process for flight crews. An analysis
of potential training costs has been added to the upper bound cost analysis in the
Regulatory Impact Analysis. The upper bound annualized costs for additional training
are estimated at $356,000.
Finally, HHS/CDC is re-inserting “Has a fever that has persisted for more than 48
hours” as a component in the definition of
Ill person in § 70.1 General definitions and “Has acute gastroenteritis, which means either
diarrhea, defined as three or more episodes of loose stools in a 24-hour period or
what is above normal for the individual, or vomiting accompanied by one or more of
the following: One or more episodes of loose stools in a 24-hour period, abdominal
cramps, headache, muscle aches, or fever (temperature of 100.4 °F [38 °C] or greater)”
in § 71.1 General definitions. This language was quoted verbatim in the preamble of
the NPRM at
81 FR 54305 but was inadvertently omitted from the proposed regulatory text.
HHS/CDC received comments from the public asserting that State and local public health
regulations already in place are sufficient to protect individuals without the need
for Federal involvement. HHS/CDC agrees that State and local authorities play an integral
role in protecting public health, but disagrees that there is no Federal role. HHS/CDC’s
DGMQ maintains quarantine stations at major U.S. ports of entry that fulfill a primary
purpose in preventing the introduction of communicable diseases into the United States,
but also play an important role in containing the interstate spread of communicable
disease. There are several broad areas of cooperation between quarantine field staff
and State and local health agencies, such as contact tracing, which provide a framework
for responding to communicable disease threats arising from interstate travel and
at the local level. It is through these networks and established partnerships, in
keeping with current practice, that the provisions of the final rule will be successfully
implemented.
HHS/CDC received a comment to the effect that quarantine specifically should be left
to the States. HHS/CDC received another comment stating that Federal authority should
not take precedence over State authority. In contrast, a public health association
suggested that these regulations should indicate that Federal public health measures
“supersede activities taken by States.” We respond that while HHS/CDC works closely
with State and local public health authorities, the Federal government has a traditional
role in preventing introductions and spread of communicable diseases at ports of entry
and interstate. HHS/CDC also disagrees with the suggestion that it should not intervene
in the event of inadequate local control or lacks authority to protect the public’s
health within the authority granted to it by Congress. 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 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. Under,
42 CFR 70.2, HHS/CDC make take action to prevent the interstate spread of communicable diseases
in the event that the CDC Director determines that inadequate local control exists.
This longstanding provision on preemption in the event of a conflict with Federal
authority is left unchanged by this rulemaking.
One public health organization requested clarification of the process to transfer
an individual from Federal to State custody and further stipulated that the State
authority should require an independent State assessment of risk under State law.
In response, HHS/CDC notes that the issuance of Federal public health orders is coordinated
with State and, when appropriate, local public health authorities. Transfer of an
individual from Federal to State custody would be similarly coordinated such that
the State would need to agree to assume custody and the State’s order would need to
be in place prior to HHS/CDC’s rescinding the Federal order. When custody of an individual
is transferred to a State authority, the State may choose, but would not be under
a Federal mandate, to conduct an independent assessment of risk pursuant to its own
policies and procedures. Furthermore, once the transfer of custody has occurred, the
State’s laws and standards for due process would apply.
Another public health authority asked for clarification of how jurisdictional issues
regarding transfers of authority affecting more than one State would be handled for
individuals under Federal quarantine. HHS/CDC responds that if more than one State
is affected by the transfer of authority, HHS/CDC will work with all relevant States
to determine the most appropriate State or local jurisdiction to accept custody of
the individual. If it is necessary to transport the individual to another State, for
example to the individual’s State of residence, HHS/CDC will work with the affected
States to facilitate such a transfer under Federal orders.
One public health organization requested clarification of the procedures HHS/CDC would
use to rescind a public health order. HHS/CDC responds that it would issue the detained
individual a written order rescinding the isolation, quarantine, or conditional release.
This would be based on either one of two criteria: The individual is determined to
no longer pose a public health threat or custody of the individual has been transferred
to a State or local public health authority.
HHS/CDC received a comment from a public health department stating that the regulations
should include language that HHS/CDC will coordinate with [*6925] State and local public health authorities and law enforcement regarding any intended
surveillance and enforcement activities. HHS/CDC strongly believes that coordination
with State and local public health authorities, as well as relevant law enforcement
entities, is essential to the public health response to individual cases as well as
outbreaks of communicable disease. On the few occasions that HHS/CDC has issued Federal
isolation orders for travelers with infectious tuberculosis, HHS/CDC has worked closely
with State and local health departments to coordinate transportation, medical evaluation,
and treatment of the ill traveler, including law enforcement when needed. During the
2014-2016 Ebola epidemic, HHS/CDC issued guidance and alerted health care and EMS
workers to consider a diagnosis of Ebola if patients had compatible symptoms and had
visited an affected country within the previous three weeks. HHS/CDC and State and
local health departments worked closely to assess any potentially exposed individuals
with symptoms compatible with Ebola to determine whether medical evaluation was needed
and, if so, to ensure safe transportation to a medical facility designated by the
health department. In light of HHS/CDC’s history of close coordination with State
and local public health authorities, including cooperating law enforcement entities
when needed, HHS/CDC has determined that specific regulatory language is unnecessary.
Some commenters questioned HHS/CDC’s authority, as well as the need, to restrict the
movement of individuals who are not ill but have been exposed. HHS/CDC thanks these
commenters for their review and input. Some quarantinable communicable diseases, such
as novel pandemic influenza strains, may be contagious before the infected person
becomes symptomatic. Therefore, in these situations, it may be necessary to restrict
the movement of asymptomatic exposed people to make sure they do not expose others
inadvertently while they are not aware that they are contagious. It may also be necessary
to restrict movement of an exposed person if public health authorities are unable
to ensure appropriate monitoring of the person, for example, if an individual is known
to have a history of noncompliance with public health recommendations. Exposed people
whose movement is restricted through quarantine or other means may be offered vaccination,
if a vaccine is available, but only with informed consent.
One commenter noted that the regulation allows HHS/CDC to issue interstate travel
permits to an infected individual conditioned upon the individual taking “precautionary
measures” as prescribed by HHS/CDC. This commenter requested that HHS/CDC clarify
what precautionary measures may be prescribed and stated that such conditions should
not be based on factors unrelated to the individual’s health condition, e.g., socio-economic, ethnic status. While HHS/CDC agrees that the issuance of a travel
permit should not be based on such factors as race, gender, ethnicity, or socio-economic
status, we note that the issuance of a travel permit may be conditioned on such factors
as the individual’s ability and willingness to comply with the terms of the permit.
Furthermore, while the exact precautionary measures prescribed may vary based on the
infectious agent, such measures, for instance, may include: Agreeing to minimize time
in congregate settings while traveling; avoiding eating in restaurants or other enclosed
public places; traveling with no other people in the vehicle or, if other people are
needed to safely operate the vehicle, agreeing to wear a mask and ensure good ventilation;
and reporting to the local health department upon arrival or on route as needed.
This commenter also requested clarification of the legal impact of a person who is
denied a permit or has had a permit revoked. We note that per the terms of the regulation
persons denied a travel permit or who have had a travel permit revoked may submit
a written appeal. The right to a written appeal, as well as the means by which an
appeal may be requested, will be addressed in the written order denying the request
for a travel permit or revoking an existing permit. The appeal will be decided by
an HHS/CDC official who is senior to the employee who denied or revoked the permit.
HHS/CDC declines to speculate as to what else this commenter may be referring to by
the term “legal impact,” but notes that the regulation does not impair the ability
of persons to seek judicial review of final agency actions through the
Administrative Procedure Act.
This commenter also requested clarification of how long an individual may be restricted
in his or her travel under a Federal travel permit. We note first that the restriction
only applies to those under a Federal public health order or under a State or local
order if the State or local health department of jurisdiction requests Federal assistance
or there is inadequate local control. In further response, HHS/CDC notes that the
restriction would remain in place so long as the individual is infected or capable
of infecting others. This commenter further requested clarification of the impact
of a disagreement between HHS/CDC and State or local public health authorities. We
note that by the terms of
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 authority. Moreover,
per the terms of
42 CFR 70.2, HHS/CDC may take action to prevent the interstate spread of communicable diseases
in the event that the CDC Director determines that inadequate local control exists.
HHS/CDC received a comment from a flight attendant union requesting clarification
as to whether an employee could be held criminally liable for knowingly transporting
someone in violation of the terms of a travel permit as specified under section 70.5.
In response, HHS/CDC clarifies that the term “operator” is defined under 70.1 consistent
with
14 CFR 1.1 and with respect to an aircraft means, “any person who uses, causes to use or authorizes
to use an aircraft, with or without the right of legal control (as owner, lessee,
or otherwise).” We further note that criminal liability, if any, will be determined
by a court of law and not administratively by HHS/CDC. Accordingly, we decline to
speculate as to whether employees who knowingly violate the terms of a travel permit
may be held criminally liable.
One public health organization asked for clarification of how local health departments
would be engaged in conducting communicable disease screening activities or enforcing
Federal public health travel restrictions for individuals traveling interstate, given
that HHS/CDC staff are not present at many points of interstate travel. HHS/CDC acknowledges
this limitation in their presence at some ports of entry and in regard to interstate
travel and intends to address this through future guidance and discussion with stakeholders.
In regard to interstate air travel, HHS/CDC clarifies that the Federal public health
Do Not Board tool will deny boarding of persons known to pose a public health risk
to other air travelers. This tool is applicable to persons boarding a commercial aircraft
with an origin or destination in the United States, including interstate travel.
See 80 FR 16400 (Mar. 27, 2015).
For other modes of travel, HHS/CDC does not have a systematic mechanism [*6926] of denying boarding and these situations may need to be addressed on a case-by-case
basis, either through direct communication with a conveyance operator or through application
of other movement restrictions such as the issuance of State or Federal public health
orders. Such situations will likely require the participation of State or local public
health authorities; however, as noted by the commenting organization, the Federal
and State/local costs and resources required during such operations are not known.
The specific roles of State or local health departments will be addressed through
future guidance or stakeholder discussion.
HHS/CDC received a comment contending that the extension of travel permits to intrastate
travel is in violation of the Commerce Clause. HHS/CDC disagrees. We note that HHS/CDC
will only require intrastate travel permits when a State or local health authority
of jurisdiction requests federal assistance or in the event that State and local actions
are inadequate to prevent interstate communicable disease spread. Under
42 U.S.C. 264, Congress acting pursuant to its Commerce Clause jurisdiction, has authorized HHS/CDC
to take measures to prevent the foreign introduction and interstate spread of communicable
diseases. It is well established that the Federal government may act to protect interstate
commerce, even though the threat may come entirely from intrastate activities.
See United States v.
Lopez, 514 U.S. 549, 558-559 (1995).
One commenter requested that HHS/CDC replace the word “traveler” with “passenger”
with respect to mandatory public health assessments, as a traveler could be taken
to mean “anybody in a private vehicle lined up at a toll booth.” In response, HHS/CDC
states that the use of the word “traveler” with respect to conveyances is intended
to include both passengers and crew. Furthermore, HHS/CDC states that its authority
extends to all individuals engaging in interstate travel including those traveling
by private vehicle, particularly if they are in the “qualifying stage” of a quarantinable
communicable disease.
HHS/CDC received a comment from a partnership of public health legal scholars and
organizations expressing concern that requiring application for a travel permit may
be unduly burdensome because individuals who are served with a conditional release
order at an airport would then need to apply for a separate travel permit to travel
to their home State of residence. HHS/CDC disagrees because under such circumstances
the conditional release order itself would include authorization for these individuals
to continue travel to their home State of residence provided that they subsequently
report to public health authorities as needed. For example, during the response to
Ebola, CDC worked with state public health authorities to allow certain individuals
who met certain risk thresholds to travel in private vehicles to their place of residence
while maintaining a focus on protecting public health. This was done on a case by
case basis, depending on distance of travel and risk of exposure, and distance from
a health care facility with adequate capacity to treat and contain Ebola. CDC would
make similar assessments in the event that conditional release orders are needed for
other quarantinable communicable diseases. We note that the conditional release order
itself would provide permission to travel and have added clarifying language to the
text.
HHS/CDC clarifies, however, that after arriving in their home State, should the individuals
wish to engage in further travel, a travel permit may be needed at that time. In response
to comments from this partnership organization, HHS/CDC also clarifies that the travel
permit, as provided for in the regulations, will only be required under circumstances
where the individual is already under a Federal, State or local order of quarantine,
isolation, or conditional release. Because the travel permit requirement is only applicable
to individuals who are already under a Federal, State, or local public health order,
HHS/CDC believes that this provision does not impermissibly restrict an individual’s
right to travel.
In response to comments regarding the time with which CDC may consider a travel permit
request, the CDC Director shall respond to a request for a travel permit within 5
business days Likewise, one public health association suggested that, in the event
a travel permit is denied, these regulations should state the timeframe that HHS/CDC
will issue a response to the appeal; another proposed the time period for CDC’s response
to be 72 hours. In response to these comments, HHS/CDC has added a requirement in
the regulation that in the event that a request for a travel permit is denied, it
must decide an appeal from that denial within three (3) business days. HHS/CDC believes
that this timeframe is appropriate because this provision only applies to individuals
who already have had their travel restricted through the issuance of a public health
order and deciding an appeal may involve coordination with affected state or local
jurisdictions.
After consideration of comments received, HHS/CDC has modified paragraphs (a), (b)(1),
(b)(2), and (c) of the provision concerning Requirements Relating to Travelers Under a Federal Order of Isolation, Quarantine,
or Conditional Release ( § 70.5) to remove “agreements,” referring to agreements entered into by the CDC.
We have also modified paragraph (a)(5) to require that HHS/CDC must issue a written
response to an appeal within three (3) business days. Other provisions of this section
are finalized as proposed.
Several commenters expressed concern that the new regulations remove the requirement
for a local health authority to be notified when a passengers falls ill or dies on
board a flight. The commenters insisted that this could interfere with effective local
response to important communicable disease threats. They propose that local authorities
should be notified in a timely manner, such as within one hour of initial reporting,
and that HHS/CDC should consult with local health authorities on the necessary steps
to contain the spread of communicable diseases. In contrast, one airline supported
the direct reporting to HHS/CDC.
HHS/CDC carefully considered these comments and responds that it will continue its
long standing partnership with local authorities. The rationale behind asking airlines
to submit reports of deaths or reportable illnesses directly to HHS/CDC as opposed
to local authorities is to simplify and streamline the reporting process for these
airlines. Under the final rule, airlines will not be required to know the current
points of contact for multiple local jurisdictions, but rather may report to HHS/CDC
as a single point of contact. HHS/CDC will continue to share public health information
with State and local health departments through approved electronic disease reporting
networks such as the Epidemic Information Exchange (Epi-X), HHS/CDC’s secure, Web-based
system. HHS/CDC may also notify State or local authorities via phone calls.
Some commenters questioned whether HHS/CDC has adequate resources to be the first
responder at the local level. HHS/CDC responds that it regularly coordinates with
Federal, State and local agencies and other partners in the airport environment. HHS/CDC
intends to continue working closely with Federal, State, and local partners, [*6927] including first responders such as EMS and State and local health agencies, when
assistance is needed.
One commenter suggested that the reporting of ill travelers “would be an invasion
of our liberty and privacy.” HHS/CDC disagrees. The report of illness or death on
board a carrier is a longstanding regulatory provision and practice. This final rule
only changes to whom the report is made (directly to HHS/CDC), rather than to the
local health department of destination. We further note that personally identifiable
information collected and maintained under the
Privacy Act will be handled in accordance with that Act and CDC’s system of records notice published
at
72 FR 70867.
Another commenter worried that “having flight reservations require health reports
will significantly impede air travel.” It is not HHS/CDC practice, nor a requirement
under this regulation, for individuals to submit health reports prior to or after
making a flight or vessel reservation. The only instance when health documents may
be required prior to travel, is if a person is known to be infectious with a communicable
disease that could spread during travel and has been placed on the Federal Public
Health Do Not Board described in
80 FR 16400 (Mar. 27, 2015). Because this practice is not new, HHS/CDC believes it will not impede
air travel.
A flight attendant association suggested that HHS/CDC should adopt training and awareness
requirements for airline employers to provide to flight attendants concerning “what
entails a qualifying stage.” Industry also expressed concern that flight crews may
be held responsible and penalized for missed illness identification. HHS/CDC understands
that the statutory definition of “qualifying stage” may be confusing to lay persons
and does not expect air or vessel crewmembers to be trained in the nuances of such
language. Instead, we have crafted a definition of ill person to focus, in plain language, on the signs and symptoms of communicable diseases of
public health concern and quarantinable communicable diseases, while taking into account
the medical resources available to aircrew. HHS/CDC intends to enforce this provision
consistent with how reports of deaths and illnesses are currently handled in regard
to foreign arrivals. We note that flight crews have not been penalized in the past
for missed reports of illness.
HHS/CDC received comments from industry that the report of death or illness should
not be limited only to the pilot in command, given the many duties already under his/her
responsibility. HHS/CDC disagrees. We clarify first that this domestic provision was
proposed to mirror the current foreign provision under
42 CFR 71.21(b)—which HHS/CDC did not propose to change—and which states “
the commander of an aircraft destined for a U.S. airport shall report immediately . . . any death
or ill person among passengers or crew.” While we acknowledge the many duties of the
pilot in command, because this individual is directly responsible and has final authority
over the operation of the aircraft, in keeping with the practice already established
through regulation under
42 CFR 71.21(b), we believe that the responsibility for reporting ill persons onboard should ultimately
rest with the pilot in command as stated in the regulation. Thus, the text of the
regulation has not changed from the proposal.
One industry group commented that the role of flight attendants in identifying sick
travelers on board should be addressed through guidance developed in conjunction with
HHS/CDC and industry. HHS/CDC responds that it routinely issues guidance for flight
crews, including standard guidance for the recognition and reporting of ill travelers
and disease- or situation-specific guidance during outbreaks. Such guidance is published
on HHS/CDC’s Web site and disseminated through established list serves, industry associations,
and any other available means. HHS/CDC will coordinate with industry partners to determine
whether additional guidance may be needed and, if necessary, work with these partners
to develop such guidance.
One industry organization commented that the proposed rule failed to recognize that
airlines employ intermediary professional medical personnel. HHS/CDC responds that
it recognizes the role of intermediary professional medical personnel in assisting
flight crews in managing an ill traveler onboard and references such personnel in
industry guidance issued at
http://www.cdc.gov/quarantine/air/index.html.
It is not HHS/CDC’s intent for the public health assessment conducted by HHS/CDC public
health officers to replace this role in medical management. However, HHS/CDC restates
that the reporting of ill travelers to HHS/CDC is the ultimate responsibility of the
pilot in command as noted above.
One association requested that the report of deaths on board a carrier be modified
and limited to those deaths which resulted from a possible communicable disease. HHS/CDC
disagrees. In keeping with current practice, HHS/CDC will continue to require and
receive the reports of all deaths that occur on board a carrier, regardless of the suspected cause, to allow
a public health official to conduct an assessment.
One public health organization raised concerns about replacing reporting to local
health authorities with reporting to HHS/CDC. In response, HHS/CDC notes that extensive
input was sought in 2012 from the Association of State and Territorial Health officers
(ASTHO) and National Association of County and City Health Officials (NACCHO). Representatives
from those organizations recommended that requirements and protocols should be the
same for international and interstate flights and procedures should be outlined describing
how this would occur. These representatives recommended that airlines should report
ill persons on domestic flights to HHS/CDC and that HHS/CDC should subsequently notify
State or local health departments. Subsequently, HHS/CDC posted guidance to this effect
on its Web site and has continued response planning and development of standard operating
procedures to implement these recommendations. Thus, this rulemaking codifies the
current practice and is consistent with recommendations provided by ASTHO and NACCHO.
One commenter stated that it appears HHS/CDC is “attempting to move towards mandatory
reporting by carriers and border personnel, requiring reporting of persons with signs
of illness as they cross borders, as opposed to having to do large-scale individual
contact interviews and investigations after an outbreak occurs.” In response, HHS/CDC
states that reporting by carriers is already required under the existing regulations
and that this regulation only codifies current practice and guidance. In addition,
DHS notifies HHS/CDC of ill travelers detected by border personnel. HHS/CDC and DHS
agreed to this notification process in a memorandum of understanding and therefore
changes to this regulation are unnecessary. HHS/CDC additionally coordinates notification
and investigation of contacts during exposure or outbreak situations when necessary
based on a public health risk assessment. Such investigations are standard public
health practice and not mutually exclusive of reporting by carriers or notifications
by border personnel.
After consideration of these comments, the title of the Radio Report of Death or Illness (71.21) in the provision has been finalized as [*6928] proposed to remove the word “Radio,” and now reads Report of Death or Illness.
One commenter questioned the seriousness of communicable disease spread on aircraft
and vessels. Another commenter noted an “extreme unlikeliness of contracting any communicable
disease while traveling” and that, therefore, HHS/CDC failed to prove a “compelling
need” for the proposed regulations. HHS/CDC appreciates the opportunity to respond
to these comments. The spread of communicable diseases on aircraft and vessels is
well documented. There are numerous reports in the medical and public health literature
of spread of measles, tuberculosis, SARS-coronavirus, and influenza virus on aircraft.
Outbreaks of varicella (chickenpox), influenza, and gastrointestinal viruses such
as norovirus are common on cruise ships, and spread of other diseases such as measles,
rubella (German measles), tuberculosis, and other gastrointestinal diseases has also
been reported. Aircraft and vessels have people together in confined spaces for prolonged
periods of time. Therefore, conducting contact investigations for certain communicable
diseases identified on aircraft or vessels is standard public health practice, both
in the United States and internationally, similar to public health practice in community
settings.
HHS/CDC received comments from industry regarding ongoing efforts with DHS/CBP to
improve passenger data collection, as announced in the NPRM. Several commenters stated
that HHS/CDC should delay this final rule until DHS/CBP has published a regulation
to ensure that a coordinated system is put in place. HHS/CDC thanks these commenters
for their input but disagrees that this final rule should be delayed. This comprehensive
regulation seeks to protect public health, by implementing, among other things, current
passenger and crew data collection practices.
One commenter objected to the collection of health information prior to using public
transportation. Another commenter opposed the idea of carriers being “forced to collect
and report 17 data elements on American travelers.” A public health association also
insisted that data elements should only be collected from people if there is a reasonable
belief that the person is infected. This final rule does not require carriers to collect
or transmit any data elements that are not currently collected and transmitted to
CBP via APIS and PNR as a result of normal operating procedures. We also take this
time to emphasize two important points. First, passengers are not required by HHS/CDC
to submit specific data elements provided by passengers. Second, HHS/CDC will only
seek this information from CBP or the airline in the event of a confirmed or suspected
communicable disease on board a carrier which requires contacting fellow passengers
to inform them of possible exposure.
While HHS/CDC received support for the data collection from two public health associations,
a commenter misread the proposals to mean that aircraft operators would be required
to develop new capacity and processes to capture and store a comprehensive set of
sensitive data, archive this data, and then provide it to HHS/CDC. HHS/CDC takes this
opportunity to restate and clarify that these final regulations do not impose any
new burdens upon the airline industry but rather, codify the current practice of receiving
a passenger manifest order (as needed) and providing HHS/CDC with any data in an airline’s
possession. This rule places no requirement on the airline to solicit or store additional
data than current practices allow. Therefore, HHS/CDC does not expect this formalization
of current practice to have an impact on operations, including “check-in process.”
If an airline does not have in its possession the five additional data elements, it
is not required to collect or submit them to CDC.
One airline industry group commented that the collection of information from screened
individuals for the purpose of contact tracing should apply only to passengers because
crewmember information would be provided by the employer. HHS/CDC responds that this
may be the case operationally; however, HHS/CDC reserves the right to collect information
directly from crew members if necessary.
HHS/CDC received a comment expressing concern that individuals may provide false contact
information, e.g. emails and telephone numbers, to airlines, and thus that HHS/CDC would lack the means
of contacting individuals. In response, HHS/CDC notes that airlines are not required
to verify the accuracy of information collected and HHS/CDC takes no position on what
consequences the airline may impose if a traveler refuses to provide information or
provides inaccurate information.
One public health organization commented on the scope of HHS/CDC’s protocols for when
contact investigations are conducted and how exposed contacts are defined following
exposures to measles or varicella on aircraft or vessels. HHS/CDC appreciates the
comment but seeks to clarify that these protocols were mentioned in the NPRM solely
for the purposes of providing context for the economic analysis and that the content
of the protocols themselves is beyond the scope of this rulemaking.
One public health organization commented on the fact that buses and trains typically
do not maintain or have access to passenger manifests that would allow for the collection
of information by HHS/CDC for the purpose of contact tracing. HHS/CDC agrees with
this comment and notes that these regulations do not require operators of buses or
trains to maintain passenger manifests for purposes of contact tracing. The organization
also commented on the utility of the requirement that operators of buses or trains
not knowingly transport individuals subject to a Federal public health order. In response,
HHS/CDC notes that it is useful to prohibit conveyance operators from knowingly transporting
someone under a Federal public health order without a travel permit or in violation
of the terms of a permit because this may limit communicable disease spread. This
prohibition, however, would only apply in circumstances where the operator would know
or have reason to know that a travel permit is required, for instance, if the conveyance
operator has been directly informed by the HHS/CDC or another cooperating Federal,
State, or local agency.
A non-profit organization also commented that requiring airlines to disclose passenger
information, upon request, but without a warrant, for purposes of notifying passengers
of their potential exposure to a communicable disease violates the Fourth Amendment
to the U.S. Constitution. This organization also contends that HHS/CDC lacks the legal
authority to require that travelers provide certain contact information, such as information
concerning their intended destination, health status, and travel history as part of
a public health investigation. Specifically, this group contends that “examination”
as used in
42 U.S.C. 264(d)(1) should be understood as referring only to an “inspection” not an “interrogation.”
This group further contends that because HHS/CDC lacks the legal authority to collect
information under
42 U.S.C. 264 it also lacks the authority to collect information under the
Privacy Act of 1974. Lastly, this group contends that any compulsory questioning of travelers about “acts
of
[*6929] assembly or association” violates the First Amendment to the U.S. Constitution.
HHS/CDC disagrees with these comments. HHS/CDC notes that the requirement of a judicial
warrant is not applicable to requiring passenger and crew information from air carriers.
Rather, this activity is permitted without a warrant under the special-needs doctrine
articulated by the Supreme Court in
Skinner v.
Railway Labor Executives’ Ass’n, 489 U.S. 602 (1989) because of the “special need” in preventing communicable disease
spread. Furthermore, requiring passenger information from airlines and questioning
travelers is authorized under
42 U.S.C. 264(a), which allows for the promulgation of regulations necessary for preventing the spread
of communicable diseases from foreign countries into the United States and interstate.
In carrying out and enforcing these regulations,
42 U.S.C. 264(a), authorizes “inspection” and “other measures” as may be necessary which allows for
inspection of airline records and questioning of travelers regarding their health
status and travel history. While
42 U.S.C. 264(d)(1) is not directly implicated in questioning of travelers because such questioning may
occur without a specific reason to believe that the individual traveler may be infected
with a quarantinable communicable disease, we note that the commenter’s suggestion
that an “examination” excludes “interrogation” is not supported by common understanding
or language usage. We note that Merriam Webster defines “examination” among other
things as “a formal interrogation.” Thus, this commenter’s suggestion that because
HHS/CDC purportedly lacks the legal authority to collect traveler information under
42 U.S.C. 264 it also lacks authority to collect information under the
Privacy Act is without merit.
HHS/CDC also rejects the suggestion that questioning of travelers violates their rights
to free association under the First Amendment. The U.S. Supreme Court has recognized
a “freedom of association” in only two distinct areas: (1) Choices to enter into and
maintain certain personal human relationships (as an element of personal liberty);
and (2) a right to associate for the purpose of engaging in other activities protected
by the First Amendment, i.e., speech, assembly, petition for redress of grievances, exercise of religious freedom.
City of Dallas v. Stanglin, 490 U.S. 19, 23-24 (1989). The purpose of this proposed requirement is to protect
the vital health interests of passengers and crew so that individuals who have been
exposed to a communicable disease during travel may be contacted, informed, and provided
with appropriate public health follow-up. HHS/CDC measures to prevent the introduction,
transmission, or spread of communicable diseases do not implicate any of these constitutionally-protected
areas.
HHS/CDC further notes that its purpose in collecting passenger information is to notify
passengers who have been potentially exposed to communicable diseases of public health
concern. For some of these diseases, there are preventive medications or vaccines
that the individual may be made aware of and wish to obtain to keep from becoming
sick. Therefore, HHS/CDC considers the collection of passenger locating information
to be of benefit to these passengers and in keeping with standard public health practice
to prevent further communicable disease transmission.
After considering these comments, HHS/CDC has finalized these provisions (71.4 and
71.5) as proposed, with the exception that the title has been modified to remove references
to “collection” and “storage” of information to more accurately reflect the requirements
under this section. References to the CDC have also been replaced with Director throughout
these sections.
Regarding provision 71.63 Suspension of entry of animals, articles, or things from designated foreign countries
and places into the United States, one public health association proposed that the restriction of animals should include
an exception for ports of entry that could provide for physical inspection. In response,
HHS/CDC clarifies that if the CDC Director determines an imported animal (or product)
poses a significant public health threat, this provision requires the Director to
designate the period of time and conditions under which entry into the United States
shall be suspended, which may include limiting entries to certain ports where physical
inspections are available. In keeping with current practice, HHS/CDC will implement
public health protection measures that strike the appropriate balance between protecting
the public’s health and continued importation and trade.
HHS/CDC received a comment that the term “thing” as used in 71.63 authorizing the
suspension of “animals, articles, or things,” based on the existence of communicable
disease in a foreign country is unduly vague. In response, we explain that HHS/CDC
may take public health measures in regard to animals, articles, or things, to prevent
the introduction, transmission, and spread of communicable diseases into the United
States and interstate. “Article” generally refers to an article of commerce, such
as a specific product that someone wishes to import into the United States or move
between States that poses a public health risk. In contrast, a “thing” simply refers
to a material object that poses a public health risk regardless of whether there is
a specific intent to import or move between States. For instance, on July 10, 2001,
CDC issued an order under the authority of section 71.32(b) requiring that imports
of “lucky bamboo” (a decorative plant) shipped in standing water be prohibited from
entering the United States because the water (
i.e., the method of packing the lucky bamboo) constituted a potential vector for mosquito-borne
illnesses.
See 66 FR 35984 (July 10, 2001). In contrast, shipments of “lucky bamboo” that were packed dry (not
in standing water) were permitted entry into the United States. In this case, “lucky
bamboo” (the decorative plant) would constitute the “article” and the standing water
would constitute the “thing.”
HHS/CDC received a question regarding the fate of animals or articles denied entry
under this regulation, stating that “articles might presumably be forfeited and pets
will be executed,” and questioning whether this provision aligns with due process,
particularly with respect to the right to appeal. In response, HHS/CDC states that
the provision authorizing temporary suspension of entry of certain animals, articles
and things based on the existence of a communicable disease in a foreign country and
to protect the public’s health is intended to prevent the arrival of these items at
a U.S. port of entry. Therefore, HHS/CDC will seek to ensure travelers are informed
of the restriction and will also work with carriers to prevent these animals or items
from being loaded onto aircraft or vessels traveling to the United States. If such
animals or items do arrive at a U.S. port of entry, HHS/CDC will take measures as
needed to protect the public’s health. Such measures will be determined on a case-by-case
basis and may include, at the owner’s expense, confinement, re-exportation, or destruction.
Re-exportation may be considered if there is no public health risk during travel.
HHS/CDC would also consider euthanasia of animals if there [*6930] are no other reasonable alternatives to protect the public’s health.
In response to the concern expressed about an “appeal,” HHS/CDC notes that the Director’s
suspension order would ordinarily constitute “final agency action” under the
Administrative Procedure Act,
5 U.S.C. 704. However, HHS/CDC will consider the appropriateness of offering an administrative
appeal as it develops the relevant suspension order.
After considering these comments, HHS/CDC has finalized the Suspension of Entry of Animals, Articles, or Things From Designated Foreign Countries
and Places Into the United States (71.63) provision as proposed.
Under Executive Order 13563 agencies are asked to consider all feasible alternatives
to current practice and the rulemaking as drafted. One less restrictive alternative
would be for HHS/CDC to stop enforcing its regulations and make compliance with current
regulations voluntary. Under this scenario, HHS/CDC would not obtain contact data
from airlines or provide such data to health departments in order to conduct contact
investigations. HHS/CDC would not require illness and death reports on aircraft or
vessels, but would still follow-up with airlines and vessel operators upon request.
This alternative would put travelers at greater risk of becoming infected with communicable
diseases, reduce the ability of public health departments to offer post-exposure prophylaxis
or other measures to prevent communicable disease spread from travelers known to have
been exposed, and generally increase the risk of communicable disease transmission
in the United States.
Another alternative, is to extend the scope of the regulations by closing U.S. borders
and ports of entry to incoming traffic from countries experiencing widespread transmission
of quarantinable communicable diseases to protect public health is also analyzed based
on the 2014-16 Ebola outbreak in West Africa as well as recent importations of Middle
East respiratory syndrome. HHS/CDC believes this approach is neither practicable nor
is it desirable.
In a separate appendix, alternatives are considered to increase or decrease HHS/CDC’s
required payments for care and treatment for individuals under Federal orders as specified
in
42 CFR 70.13 and
42 CFR 71.30. Also in a separate appendix, alternatives are also considered in which HHS/CDC does
not implement temporary animal import embargos (less restrictive) or does not allow
importation of animals under temporary embargos for science, education, and exhibition
when accompanied by a special permit.
We believe the regulations described above and set forth below in text offer the best
solutions for protecting U.S. public health while allowing for continued travel. HHS/CDC
believes that this rulemaking complies with Executive Order 13563; all of these changes
provide good alternatives to the current baseline.
HHS/CDC has examined the impacts of the final rule under Executive Order 12866, Regulatory
Planning and Review (
58 FR 51735, October 4, 1993)
2 and Executive Order 13563, Improving Regulation and Regulatory Review, (
76 FR 3821, January 21, 2011).
3 Both Executive Orders direct agencies to evaluate any rule prior to promulgation
to determine the regulatory impact in terms of costs and benefits to United States
populations and businesses. Further, together, the two Executive Orders set the following
requirements: Quantify costs and benefits where the new regulation creates a change
in current practice; define qualitative costs and benefits; choose approaches that
maximize net benefits including potential economic, environmental, public health and
safety, and other advantages; support regulations that protect public health and safety;
and minimize the adverse impact of regulation. HHS/CDC has analyzed the final rule
as required by these Executive Orders and has determined that it is consistent with
the principles set forth in the Executive Orders and the
Regulatory Flexibility Act,
4 as amended by the
Small Business Regulatory Enforcement Fairness Act (SBREFA)
5 and that, relative to the status quo, the final rule will not be economically significant
because the sum of annualized costs and benefits are estimated to be much less than
$100 million in any given year.
However, there is uncertainty about the appropriate analytic baseline, and relative
to some possible baselines, the effects of the rule are non-negligible. For example,
if in the absence this rule, some aspects of future HHS/CDC screening or risk assessment
activities are found to be legally impermissible, then the status quo baseline would
not represent a reasonable approximation of the state of the world without the rule.
Relative to a non-status quo baseline, the rule would lead to activities (e.g., the 2014-16 Ebola risk assessment and management program) that have both substantial
costs and substantial benefits. Analyses relative to this non-status quo baseline
are presented in a separate appendix.
This Regulatory Impact Analysis (RIA) section presents the anticipated costs and benefits
that are quantified where possible are relative to the status quo baseline. Where
quantification is not possible, a qualitative discussion is provided of the costs
and/or benefits that HHS/CDC anticipates from issuing these regulations.
The 2014-2016 Ebola response highlights the inadequacies and limitations of the current
regulatory provisions on the traveler data collection process in which CDC must request
traveler manifests from airlines and manually search for contact data in order to
know who enters the United States, where they go, and how to contact them.
Airlines have been slow to respond to HHS/CDC requests for traveler manifests:
○ 30% arrive more than three days after a request,
○ 15% arrive more than six days late.
In addition, available locating information is usually incomplete: HHS/CDC receives
only the name and seat number for 61% of travelers, and one or more additional pieces
of information for 39% of travelers. This final rule clarifies HHS/CDC’s existing
authority to request any available contact data from airlines and vessel operators,
which may improve the timeliness and completeness of future requests from airlines
or vessel operators for data not already submitted to the Department of Homeland Security.
Some traveler contact data is available in the APIS/PNR dataset already submitted
by airlines to CBP. In the experience of the HHS/CDC, queries from APIS/PNR rarely
result in full sets [*6931] of contact information (i.e. the record includes all five additional data fields as outlined in the final rule).
The data fields that are most commonly missing from the records are email addresses
(missing 90 percent of the time), secondary phone number (missing 90 percent of the
time), and street addresses (missing or insufficient for public health contact tracing
up to 50 percent of the time). These data elements are vital to a contact tracing
investigation. In looking at a random sample of 20% of the compiled international
air travel manifests for 2015, those including a compiled data set from NTC and the
airlines, 100% were missing at least one of the 5 data fields. Email address and secondary
phone number were among those most frequently missing. For context, there were approximately
760,000 scheduled flights that arrived into the United States in 2015. In 2015, HHS/CDC
issued passenger manifest requests for 64 international flights arriving into the
United States. As noted in the RIA of the final rule, from 2010 to 2015, HHS/CDC conducted
an average of 77 contact investigations per year involving arriving international
flights.
Airlines are contacted for the majority of contact investigations using a manifest
order document. At a minimum, HHS/CDC needs to confirm the ill traveler was on the
flight and where the individual sat in relation to other travelers to determine risk
of exposure. Further, in HHS/CDC’s experience, only airlines can:
• Quickly and efficiently produce a partial manifest targeting affected rows
• confirm identity of “babes in arms” and their co-travelers (Parent); this is important
for measles cases;
• quickly confirm whether an individual actually flew (in instances where individuals
deplane and do not re-board during a layover); and
• confirm a plane’s configuration if there is a question with the provided row numbers.
Different aircraft have different seating arrangements depending on carrier and layout.
It is important to know if a certain seat is separated by a bulkhead or is a window
seat.
In addition, HHS/CDC only requires a partial manifest, e.g. 5 rows for travelers with infectious tuberculosis, so that NTC and HHS/CDC staff
can limit the investigation to only those passengers at risk and supplement/cross
reference with APIS and PNR data. If a partial manifest is not available from the
airlines, then each passenger record must be researched individually to find a seat
number, and then the configuration of an entire plane must be populated to determine
where the index case sat in relation to other at-risk passengers. For large flights
from Asia, this can pose a tremendous burden to NTC and CDC staff while slowing the
ability of CDC to provide important contact information to state and local health
departments. Manually populating multiple 300+ person flights is not feasible in a
timely manner.
Finally, CDC wishes to reiterate its desire for the above-described operations to
be published in regulation to provide the public, as well as industry, with understanding
of the efforts made by CDC to protect public health.
The other change to the economic baseline that may result from this final rule was
the need to change the definition of an “ill person” to better match HHS/CDC guidance
and the guidelines contained in Note 1 to paragraph 8.15 of Annex 9 to the Convention
on International Civil Aviation. Where possible, the marginal costs and benefits of
these changes relative to the status quo baseline are monetized.
In addition, HHS/CDC believes that there is a need to better communicate to the public
the actions that it has taken in accordance with its regulatory authority under
42 CFR 70.6 Apprehension and detention of persons with specific diseases, 42 CFR 71.32 Persons, carriers, and things, and
§ 71.33—Persons: Isolation and surveillance. HHS/CDC believes it is necessary for the public to better understand actions that
may be taken to prevent the importation of communicable diseases and to explain the
due process available to individuals under Federal orders for isolation, quarantine,
or conditional release. HHS/CDC also believes it is important to explain when HHS/CDC
may authorize payment for the care and treatment of individuals subject to medical
examination, quarantine, isolation and conditional release.
Finally, HHS/CDC believes it is important to explain its regulatory authority to suspend
entry of animals, articles or things from designated foreign countries and places
into the United States when importation increases the risk of the introduction and/or
transmission of a communicable disease within the United States.
The specific market failure addressed by these regulations is that the costs associated
with the spread of communicable diseases impacts the entire U.S. population, not just
the group of persons currently infected with communicable diseases or with business
interests in providing interstate or international travel to persons or animals infected
with communicable diseases.
The economic impact analysis of this final rule is subdivided into four sections:
1. An analysis of
42 CFR 70.1,
42 CFR 71.1/71.4/71.5, for which the primary costs may be incurred by aircraft and vessel operators
and the primary benefit is improved public health responsiveness to assess and provide
post-exposure prophylaxis to travelers exposed to communicable diseases of public
health concern.
2. An analysis of a number of provisions that aim to improve transparency of how HHS/CDC
uses regulatory authorities to protect public health. These changes are not intended
to provide HHS/CDC with new regulatory authorities, but rather to clarify the agency’s
standard operating procedures and policies, and due process rights for individuals.
HHS/CDC believes that improving the quality of its regulations by providing clearer
explanations of its policies and procedures is an important public benefit. However,
HHS/CDC is not able to attach a dollar value to this added benefit in a significant
way. In a separate appendix, HHS/CDC analyzes the costs and benefits associated with
the 2014-2016 Ebola enhanced risk assessment and management program are used to illustrate
the costs and benefits of implementation of some of these authorities, and are especially
relevant when analyzing the effects of the rule relative to a non-status quo baseline.
3. In a separate appendix, HHS/CDC provides an analysis of the revisions to
42 CFR 70.13/71.30: Payment for care and treatment, which are not expected to lead to a change in HHS/CDC policy under which HHS/CDC
may act as the payer of last resort for individuals subject to medical examination,
quarantine, isolation, and conditional release under Federal orders. The primary benefit
of codification is increased transparency around HHS/CDC policies to assist in paying
for treatment or transportation for individuals under Federal orders. The analysis
for these provisions is an examination in potential transfer payments between HHS/CDC
and healthcare facilities that provide treatment to individuals under Federal orders
or to other payers.
4. In a separate appendix, HHS/CDC provides an analysis of
42 CFR 71.63: Suspension of entry of animals, articles, or things from designated foreign countries
and places into the United States. In this final rule, HHS/CDC is
[*6932] explaining its existing regulatory authority. HHS/CDC cannot predict how often such
authority may be used in the future or for what purpose. HHS/CDC previously exercised
this authority on June 11, 2003, when under
42 CFR 71.32(b), HHS/CDC implemented an immediate embargo on the importation of all rodents from
Africa (order Rodentia).
6 A simple economic impact analysis of this embargo is performed to demonstrate the
costs and benefits of one example, but HHS/CDC does not anticipate an increase in
frequency of such actions based on the provisions included in this final rule. The
primary purpose of the analysis is to demonstrate potential costs and benefits using
a realistic example.
6 Federal Register 62353 Vol. 68, No. 213 Tuesday, November 4, 2003. P. 62353-69.
Table 1 provides a summary of whether quantitative or qualitative analyses were performed
for each of the provisions in the final rule.
Table 1—Summary of Provisions Included in This Final RuleProvision | Qualitative impacts only | Codification of existing authority |
§ 70.1/ § 71.1 General Definitions | No a | Yes (except definition of “ill person”). |
§ 70.5 Requirements relating to travelers under a federal order of isolation, quarantine,
or conditional release | Yes | Yes. |
§ 70.6 Apprehension and detention of persons with specific diseases; § 71.32 Persons,
carriers, and things (no change to title) | Yes | Yes. |
§ 70.10/ § 71.20 Public health prevention measures to detect communicable disease | Yes b | Yes. |
§ 70.11 Report of death or illness onboard aircraft operated by an airline | Yes | Yes. |
§ 70.12/ § 71.36 Medical examinations | Yes | Yes. |
§ 70.13/ § 71.30 Payment for Care and Treatment | Yes c | Yes. |
§ 70.14/ § 71.37 Requirements relating to the issuance of a Federal order for quarantine,
isolation, or conditional release | Yes | Yes. |
§ 70.15/ § 71.38 Mandatory reassessment of a federal order for quarantine, isolation,
or conditional release | Yes | Yes. |
§ 70.16/ § 71.39 Medical review of a federal order for quarantine, isolation, or conditional
release | Yes | Yes. |
§ 70.17/ § 71.29 Administrative records relating to federal quarantine, isolation,
or conditional release | Yes | Yes. |
§ 70.18/ § 71.2 Penalties | Yes | Yes. |
§ 71.4 Requirements relating to collection, storage and transmission of airline passenger,
crew and flight information for public health purposes | No a | Yes. |
§ 71.5 Requirements relating to collection, storage and transmission of vessel passenger,
crew, and voyage information for public health purposes | No a | Yes. |
§ 71.33 Persons: Isolation and surveillance | Yes | Yes. |
§ 71.63 Suspension of entry of animals, articles, or things from designated foreign
countries and places into the United States | Yes d | Yes. |
a Analyzed in RIA. |
b The costs and benefits associated with the 2014-2016 Ebola enhanced risk assessment
and management program are used to illustrate the costs and benefits in a separate
appendix. |
c In a separate appendix, an analysis of previous HHS/CDC payments for care and treatment
is provided. However, the provisions in the Final Rule are not expected to lead to
a change in HHS/CDC policy under which HHS/CDC may act as the payer of last resort
for individuals subject to medical examination, quarantine, isolation, and conditional
release under Federal orders. |
d In a separate appendix, HHS/CDC provides an analysis of this provision based on past
experience when HHS/CDC implemented an immediate embargo on the importation of all
rodents from Africa. |
The quantified costs and benefits of the final rule are estimated for the following
stakeholders: Air and maritime conveyance operators, State and local public health
departments (PHDs), individuals exposed to communicable diseases during travel and
United States Government (USG). The most likely estimates of primary costs are low
($32,622, range $10,959 to $430,839) because the final rule primarily codifies existing
practice or improves alignment between regulatory text and the symptoms reporting
guidelines provided by the International Civil Aviation Organization (ICAO). The cost
estimates are based on an increase in:
• The number of illness reports delivered by airlines and vessel operators to CDC,
relay of air illness reports to CDC by the Federal Aviation Administration (FAA) when
such reports are received by FAA air traffic service units, illness reports processed
by HHS/CDC and time for travelers;
• increased costs for airlines and vessel operators to comply with HHS/CDC requests
for traveler contact data;
• increased costs for State and local public health departments to follow up with
a larger number of travelers exposed to communicable diseases during travel;
• The upper bound cost estimate also includes a substantial increase in training costs
for the changes to illness reporting.
The best estimate of quantified benefits of the final rule is also relatively small
$110,045 (range $26,337 to $297,393). This estimate is based on expected improvements
in illness reporting and in the timeliness, completeness, and accuracy of contact
data. These improvements should result in increased efficiencies for HHS/CDC and State
and local public health departments in conducting contact investigations among travelers
exposed to communicable diseases on aircraft and vessels and reduced illness costs
associated with the reduced risk of measles and tuberculosis morbidity and mortality
in exposed travelers.
Other potential but non-quantified benefits of the final rule would be associated
with future outbreaks of
[*6933] infectious disease cases for which improved compliance by airlines and vessel operators
to provide available traveler contact data would reduce onward spread of disease in
the destination communities of exposed travelers. In addition, the change to the definition
of “ill person” may also increase reporting of communicable diseases of public health
concern onboard conveyances. Reduction in onward spread would also lead to the ability
of the public health establishment to reduce effects of disease outbreaks,
e.g., delay the spread of disease until a vaccine is available or limit the numbers of
outbreaks and cases or reduce public anxiety associated with the risk of transmission.
There may also be a reduction in the economic costs of many business sectors such
as avoidance of costs to the travel and tourism industry
78 when a disease is contained in its early stages.
7 Rassy D, Smith RD. The economic impact of H1N1 on Mexico’s tourist and pork sectors.
Health Econ. 2013;22(7):824-34. doi: 10.1002/hec.2862. PubMed PMID: 23744805.
8 Keogh-Brown MR, Smith RD. The economic impact of SARS: How does the reality match
the predictions? Health Policy. 2008;88(1):110-20.
Section 202(a) of the
Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing “any 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 [$146,000,000 in 2015 USD] or more.”
Not only will this final rule not cost State, local and tribal governments any expenditure,
it is possible that these stakeholders who might be engaged in contact tracing may
see a reduction in costs if the final rule is implemented and there is an improvement
in airline compliance with HHS/CDC requests to provide traveler data.
Traveler contact information will only be requested by HHS/CDC after a case of serious
communicable disease (index case) is reported in a person who traveled on a commercial
airline or vessel while contagious. Examples of serious communicable diseases include
measles, novel influenzas, and viral hemorrhagic fevers such as Ebola among others.
This type of situation necessitates identifying and locating passengers seated near
the index case in order to conduct a contact investigation (CI). This final rule would
lead to better health outcomes if public health departments are more quickly and effectively
able to contact persons potentially exposed to the index case on an aircraft or vessel.
These increased efficiencies should lead to smaller infectious disease outbreaks and
fewer public health resources needed to control an outbreak.
There are multiple communicable diseases including quarantinable (e.g., tuberculosis, MERS, and Ebola) and non-quarantinable (e.g., measles, varicella, pertussis, rabies, meningococcal, and rubella) diseases that
may necessitate a contact investigation to prevent spread of disease in the community.
HHS/CDC notes that for non-quarantinable diseases, HHS/CDC efforts would primarily
be limited to assisting health departments to notify individuals of their potential
exposures. HHS/CDC was unable to quantify the benefits of preventing the spread of
all diseases as a group because of differences in the characteristics of each disease.
The differences with respect to potential spread and impact make it difficult to assess
the benefits that may accrue from reduced spread of all diseases. The quantified analysis
focuses on the two diseases that generate the greatest number of contacts to follow
up: Measles and tuberculosis.
The ongoing persistence of measles in the United States provides a good example of
the need for this final rule. In 2000, measles was declared no longer endemic in the
United States due to high vaccination rates. Cases and outbreaks of measles continue
to occur, however, as a result of importation from other countries and lack of adherence
to the recommendation for measles vaccination (
http://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/mmr.html). The United States is currently discovering the greatest number of measles cases
that have been identified since the declaration of measles elimination; 97% of recent
cases were associated with importations from other countries. Of 45 direct importations,
40 occurred in U.S. citizens after traveling abroad.
9
9 Gastañaduy, P.A., S.B. Redd, A.P. Fiebelkorn, J.S. Rota, P.A. Rota, W.J. Bellini,
J.F. Seward and G.S. Wallace (2014). “Measles—United States, January 1-May 23, 2014.”
MMWR 63(22): 496-499.
Among air travelers exposed to measles during flights, post-exposure prophylaxis (PEP)
with measles-containing vaccine (within 72 hours) or immune globulin (within 6 days)
can prevent onset of disease,
10 halting outbreaks before they begin. However, without accurate and timely contact
data, it is frequently difficult to intervene within these timelines. A recent analysis
showed that 9 cases likely occurred as a result of exposure during 108 flights with
74 case-travelers over 3 years. Although there was no onward transmission from these
9 cases,
11 future cases may lead to larger outbreaks.
10 Nelson, K., Marienau, K.J., Schembri, C. and Redd, S. (2013). “Measles transmission
during air travel, United States.” Travel Medicine and Infectious Disease (2013) 11,
81e89 11: 81-89.
11 Nelson, K., Marienau, K.J., Schembri, C. and Redd, S. (2013). “Measles transmission
during air travel, United States.” Travel Medicine and Infectious Disease (2013) 11,
81e89 11: 81-89.
Measles outbreaks can have substantial associated costs. One model-based analysis
showed that 16 outbreaks with 107 confirmed measles cases cost an estimated $2.7 million
to $5.3 million U.S. dollars for public health departments to contain.
12 The estimate is based on outbreak-specific travel expenses and the opportunity cost
of diverting public health staff to outbreak response activities and is not based
on the cost of hiring additional staff. This corresponds to an average cost per outbreak
of about $250,000 in 2015 USD. In comparison, a total of 125 cases occurring in 8
States and three countries were associated with a single measles outbreak that originated
in late December 2014 in amusement theme parks in Orange County, California.
13 Thus, the number of cases in this one outbreak exceeded the total number of outbreak-associated
cases identified in 16 outbreaks during 2011. The source of the initial exposure has
not been identified so it is not possible to determine where this index case was exposed.
However, this example demonstrates the speed with which communicable diseases can
be transmitted and the importance of quickly identifying persons that may have been
exposed during air or maritime travel. It is possible that the costs of this one outbreak,
which spread across 8 States, exceeded the total costs of all 16 outbreaks that occurred
in 2011 and were estimated to cost public health departments a total of $2.7 million
to $5.4 million dollars.
14
12 Ortega-Sanchez, I.R., M. Vijayaraghavan, A.E. Barskey and G.S. Wallace (2012). “The
economic burden of sixteen measles outbreaks on United States public health departments
in 2011.” Vaccine 32(11).
13 Jennifer Zipprich, Kathleen Winter, Jill Hacker, Dongxiang Xia, James Watt, Kathleen
Harriman. (2015) Measles Outbreak—California, December 2014-February 2015. MMWR/February
20, 2015/Vol. 64/No. 6: 153-154.
14 Ortega-Sanchez, I.R., M. Vijayaraghavan, A.E. Barskey and G.S. Wallace (2012). “The
economic burden of sixteen measles outbreaks on United States public health departments
in 2011.” Vaccine 32(11).
In the absence of interventions by public health departments, travelers [*6934] infected with measles during international travel would be as likely as any other
individuals to initiate a measles outbreak. In the absence of HHS/CDC efforts to retrieve
and transmit contact data, public health departments would not be able to contact
travelers to offer post-exposure prophylaxis and to recommend self-monitoring for
potential measles symptoms.
The Summary Table provides estimated total monetary results for stakeholders’ costs
and benefits of implementing the final rule. The Summary Table (Table 2) includes
estimates associated with changes to the definition of ‘ill person’ in
42 CFR 70.1/71.1 and the codification of international traveler data collection processes of
aircraft and vessel contact investigations under
42 CFR 71.4/71.5. The best estimates of annual costs are $32,622 compared to the best estimate
of annual benefits at $110,045. The upper bound annual quantified costs are $430,839
and the upper bound quantified benefits are $297,393. Lower bound quantified costs
are $10,959 and benefits are $26,337.
The measles and tuberculosis examples should not be considered a complete estimate
of non-quantified benefits associated with this final rule, because the impact of
this final rule to mitigate many different types of infectious disease outbreaks cannot
be quantified. It just provides examples based on the two diseases for which contact
investigations are most frequently undertaken. Besides communicable diseases commonly
reported in the United States (e.g., measles, tuberculosis), this final rule may also improve HHS/CDC’s ability to respond
to diseases that are infrequently diagnosed in the United States (e.g., Ebola, novel influenza, Middle East Respiratory Syndrome). For example, it is possible
that HHS/CDC may need to prepare to address both Ebola and another disease such as
novel influenza or Middle East Respiratory Syndrome (MERS) occurring in two separate
countries or regions during a given year. For example, in 2014, two international
travelers on commercial flights from the Middle East arrived in the United States
while infected with MERS and two international travelers on commercial flights from
West Africa arrived while infected with Ebola. Regardless of the infectious disease
scenarios faced by HHS/CDC in a given year, this final rule should improve HHS/CDC’s
ability to mitigate infectious diseases in the future. To the extent that the final
rule would lead to improved responsiveness of airlines and vessel operators to HHS/CDC
traveler data requests via manifest orders, HHS/CDC may become better able to respond
to infectious diseases threats and (1) reduce case-loads during infectious disease
outbreaks, (2) reduce public anxiety during disease outbreaks, (3) mitigate economic
impacts on businesses as a consequence of reduced public anxiety, and (4) reduce the
amount of personnel labor time to conduct large-scale contact investigations in response
to a new infectious disease or one with serious public health and medical consequences
like Ebola.
Table 2—Summary of Monetized and Qualitative Benefits and Costs of the Final Rule
[2015 USD]Category | Most likely estimate | Lower bound estimate | Upper bound estimate | Source citation (RIA, preamble, etc.) |
BENEFITS |
Annual monetized routine benefits from reduced effort by CDC and health department
to search for exposed contacts (0% discount rate) | $12,218 | $0 | $12,218 | RIA. |
Annual monetized routine benefits from reduced illness (0% discount rate) | $97,828 | $26,337 | $272,958 | RIA. |
Total annual monetized routine benefits (0% discount rate) | $110,045 | $26,337 | $285,175 | RIA. |
Qualitative (unquantified benefits) | To the extent that airlines or vessel operators have data available and improve responsiveness
of airlines and vessel operators to HHS/CDC traveler data requests results from the
implementation of the provisions in this final rule, HHS/CDC may become better able
to respond to infectious diseases threats and (1) reduce case-loads during infectious
disease outbreaks, (2) reduce public anxiety during disease outbreaks, (3) mitigate
economic impacts on businesses as a consequence of reduced public anxiety, and (4)
reduce the amount of personnel labor time to conduct large-scale CIs in response to
a new infectious disease or one with serious public health and medical consequences
like Ebola. | RIA. |
COSTS |
Annual monetized costs for changes to illness reporting (airlines and vessel operators,
0% discount rate) * | $0 | $0 | $376,554 | RIA. |
Annual monetized costs for changes to codification of manifest order process (airlines
and vessel operators), 0% discount rate) * | $12,654 | $0 | $25,308 | RIA. |
Annual monetized costs for additional activities by health department contacting individuals
exposed to communicable diseases during international travel (0% discount rate) | $19,968 | $10,959 | $28,977 | RIA. |
Total annual monetized routine costs (0% discount rate) | $32,622 | $10,959 | $430,839 | RIA. |
Annual quantified, but unmonetized, costs | None | RIA. |
Qualitative (unquantified) costs | None | RIA. |
The second analysis in this final rule is of a number of provisions that aim to improve
transparency of how HHS/CDC uses its regulatory authorities to protect public health.
These changes are not intended to provide HHS/CDC with new regulatory authorities,
but rather to clarify the agency’s standard operating procedures and policies with
regard to pre-existing regulations in
42 CFR parts 70 and
71 including due process rights for individuals under Federal orders. HHS/CDC believes
that improving the quality of its regulations by providing clearer explanations of
its policies and procedures is an important public benefit. However, HHS/CDC is not
able to attach a dollar value to this added benefit in a significant way.
The group of entities that may be affected by this final rule would include international
and interstate aircraft operators, vessel operators, travelers, State or local health
departments and the Federal government agencies that interact with these groups. Since
this final rule primarily updates regulatory requirements to better match current
practice, the economic impacts are marginal changes to current practice that result
from codification of current practices.
The North American Industry Classification System (NAICS) is used by Federal statistical
agencies in classifying business establishments for the purpose of collecting, analyzing,
and publishing statistical data related to the U.S. business economy. A summary of
the total numbers of each entity is summarized in Table 3.
Table 3—Summary of the Number of Firms Engaged in Interstate and International Air
and Maritime TravelNAICS codes | NAICS description | Number of firms in industry |
481111 | Scheduled Passenger Air Transportation | 264 |
481112 | Scheduled Freight Air Transportation | 212 |
481219 | Other Nonscheduled Air Transportation | 516 |
483111 | Deep Sea Freight Transportation | 191 |
483112 | Deep Sea Passenger Transportation | 54 |
483113 | Coastal and Great Lakes Freight Transportation | 337 |
483114 | Coastal and Great Lakes Passenger Transportation | 110 |
483211 | Inland Water Freight Transportation | 318 |
483212 | Inland Water Passenger Transportation | 193 |
Statistics of U.S. Businesses, 2013 U.S. all industries.15 |
2012 North American Industry Classification System (NAICS).16 |
According to a report by the Federal Aviation Administration, in 2012, U.S. civil
aviation-related economic activity generated $1.5 trillion and supported 11.8 million
jobs with $459.4 billion in earnings.
17 In 2015, the domestic U.S. market for air travel included 696 million passengers
and the international market included another 198 million travelers.
18
In 2011, there were approximately 11 million North American cruise ship passengers
spending 71.8 million passenger nights on board vessels. The cruise ship market was
highly concentrated with four firms accounting for 98% of the total market.
19 In total, approximately 18 million travelers enter the United States each year via
cruise or cargo ships.
20
The domestic/international air carrier market is an ever-shifting corporate landscape.
Both U.S. and foreign airlines engage in “code-sharing” arrangements, whereby the
marketing carrier places its call sign (or code) on the operating carrier’s flight.
For purposes of this rule, reporting duty would require the operating carrier to report
on all passengers and crewmembers, whether traveling on the operator’s code or another carrier’s.
The complexity of the domestic/foreign airline-corporations’ legal and financial arrangements
makes it very difficult to ascertain exactly how each and every domestic and foreign
airline would be affected by the implementation costs associated with this final rule;
presumably, some of the costs might be passed along to the carrier putting its code
on the operating carrier, pursuant to the particular terms of each applicable contract.
[*6936]
Under this final rule, the operator of any airline operating a flight arriving into
the United States must make certain contact information described below available
within 24 hours of a request by HHS/CDC, to the extent that such data are available
to the operator. This requirement also applies to the operator of any vessel carrying
13 or more passengers (excluding crew) and, which is not a ferry as defined in under
46 U.S.C. 2101 and U.S. Coast Guard (USCG) regulations (
46 CFR 2.10-25). This requirement is a codification of current practice, and applies to any of the
data elements that the airline or vessel operator may have available and authorizes
the airline or vessel operator to transmit the contact information in any format and
through any system available and acceptable to both the airline and HHS/CDC. Again,
because this is a codification of current practices, HHS/CDC assumes airlines and
vessel operators will continue to submit data through current mechanisms, although
HHS/CDC will accept others that are mutually acceptable.
To simplify the analysis and to develop conservative cost estimates, HHS/CDC assumed
that all costs to airlines and vessel operators would be passed along to U.S.-based
airlines, vessel operators, or U.S. consumers.
HHS/CDC has gathered statistics, or reported information on, a number of notifiable
and quarantinable diseases (Table 4) that form the basis for estimates of quantitative
and qualitative benefits. The final rule provides CDC with the authority to take certain
actions with regard to both quarantinable and non-quarantinable diseases. For non-quarantinable
diseases, efforts would be primarily limited to early identification and notification
of exposed individuals and transmission of contact data to local and State health
departments. For quarantinable diseases, efforts could include issuance of Federal
orders for quarantine, isolation, or conditional release of exposed/infected individuals.
Table 4—Diseases AnalyzedNon-quarantinable | Quarantinable |
Measles Pertussis Rabies Meningococcal disease Varicella Rubella | Tuberculosis. Viral Hemorrhagic Fevers. Middle East Respiratory Syndrome Coronavirus
(MERS). |
In addition, these diseases for which HHS/CDC currently issues manifest orders and
conducts contact investigations can also be subdivided to identify those encountered
with some frequency (routine diseases): Tuberculosis, measles, meningococcal disease,
pertussis and rubella. Among these diseases, only tuberculosis is a quarantinable
disease. The second class is a group of new or emerging diseases, or diseases with
serious public health and medical consequences, that are not currently prevalent,
but are foreseeable as a future threat, e.g., severe acute respiratory syndromes (including SARS and MERS), Ebola. This second
group only includes quarantinable diseases, which may be updated in the future by
Executive Order, but which are not being updated as a part of the final rule. Although
HHS/CDC may help identify travelers ill with or exposed to measles, meningococcal
disease, pertussis, rubella, rabies, and varicella, HHS/CDC does not have the authority
to place any travelers with such illnesses or exposures under Federal orders. For
quarantinable diseases, illness reporting could lead to issuance of Federal orders
if travelers are reasonably believed to be infected with a quarantinable communicable
disease in a qualifying stage. Such restrictions would not occur based simply on an
illness report by airline or vessel operator staff and would require a medical assessment
by a public health professional.
The number of travelers exposed to an index case that are subject to a contact investigation
(CI) varies by disease and may include only the two passengers sitting adjacent to
the index case (meningococcal disease or pertussis) or as much as the entire aircraft
(e.g., initial investigations of cases of MERS or Ebola) (Table 5). The entire aircraft
or vessel may be subject to CI if the disease is new and transmission patterns are
not well understood (e.g., MERS) or if the disease is felt to have serious medical or public health consequences
(e.g., Ebola). Some CIs are only initiated for long-duration travel (e.g., tuberculosis for flights of 8 hours or longer). For other diseases (e.g., measles, MERS), CIs are undertaken regardless of duration.
The table also includes criteria to be considered a contact for persons exposed on
vessels. In contrast to air contact investigations, most maritime contact investigations
are undertaken before travelers disembark from vessels. Another difference between
air and maritime contact investigations is that varicella contact investigations are
frequently undertaken among maritime travelers on vessels, but are not pursued for
air travelers. In addition, HHS/CDC has not yet had to conduct a contact investigation
for Middle East Respiratory Syndrome or viral hemorrhagic fever for travelers exposed
on vessels. The criteria listed in Table 5 are current as of October 2016, but may
be updated in the future based on reviews of the effectiveness of contact investigations.
For example, HHS/CDC stopped providing contact data to health departments for mumps
investigations after reviewing evidence of the effectiveness of mumps contact investigations.
Table 5—Contact Investigation Criteria by Disease, PHD Follow UpDisease | CI initiated if | Persons contacted, aircraft | Persons contacted, vessels | Recommended activities |
Ebola (Quarantinable) | All cases | All passengers and crew as of April 2016. In the future, the recommendation may change
to include fewer passengers and crew | Cruise vessel—any passenger or crew who made have come into contact with the index
case’s body fluids while the index case was symptomatic Cargo vessel—all on board
the vessel while the index case was symptomatic | Monitoring for 21 days after last potential exposure. |
Measles (Non-quarantinable) | All cases if notification received within 21 days of flight | Passengers seated within 2 rows either direction of the index case, all babies-in-arms,
crew in same cabin. All passengers and crew on flights with <50 seats | Direct face-to-face contact or shared confined space >1 hour with symptomatic case-patient | Offer MMR vaccination if non-immune and <72 hrs. since exposure; immune globulin if
indicated and within 6 days of exposure. |
Meningo-coccal disease (Non-quarantinable) | Case meets the definition of meningococcal disease within 14 days of travel For air
travel: Flight >8 hrs. (or shorter flights if direct exposure reported) | Passengers or crew sitting directly to the left and right of the index case or with
potential for direct contact with oral or respiratory secretions | Cruise vessels—Cabin mates of or potential for direct contact with oral or respiratory
secretions of case-patient during the 7 days prior to symptom onset until 24 hours
after implementation of effective antimicrobial therapy Cargo vessels—All on board
the vessel during the 7 days prior to symptom onset of case-patient until 24 hours
after implementation of effective antimicrobial therapy | Post-exposure chemoprophylaxis. |
New or reemerging influenza viruses (Quarantinable) | All cases during early stages of international spread | All passengers and crew | All crew and passengers | Monitoring for 10 days after last potential exposure; possible serologic testing. |
Pertussis (Non-quarantinable) | All cases if notification is received within 21 days of travel | Passengers sitting next to index case | Direct face-to-face contact or shared confined space >1 hour with symptomatic case-patient | Post-exposure chemoprophylaxis. |
Rubella (Non-quarantinable) | All cases if notification is received within 60 days of travel | Passengers seated within 2 rows + crew in same cabin. All passengers and crew on flights
with <50 seats | Direct face-to-face contact or shared confined space >1 hour with symptomatic case-patient | Serologic testing and guidance for pregnant women. |
Severe Acute Respiratory Syndromes (Quarantinable) | All cases | SARS-Coronavirus: All passengers and crew MERS: All passengers and crew contacted
during 2014 CIs. Future CIs will include passengers seated within 2 rows of index
case | Cruise vessel—any passenger or crew who had direct face-to-face contact or shared
confined space >1 hour with symptomatic case-patient Cargo vessel—all on board the
vessel while the index case was symptomatic | Monitoring for 10-14 days after last potential exposure; potential serologic testing. |
TB (Quarantinable) | Notification received within 3 months of travel, clinical criteria met For air travel:
Flight >8 hrs | Passengers seated within 2 rows | Cargo vessel: All crew members within 3 months of diagnosis who worked with case-patient
Cruise vessel: Passenger travel companions or crew working in close proximity/sharing
living quarters | Aircraft: Testing for latent TB infection; chest radiograph if the LTBI test is positive.
Vessels: Clinical assessment for symptoms and chest radiograph. |
Varicella (Non-quarantinable) | All cases on vessels | NA | Any person who has had ≥5 minutes of direct face-to-face contact with a varicella
case during the infectious period | Varicella vaccination if unvaccinated/non-immune and <3 days since exposure (possibly
up to 5 days). High-risk contacts evaluated Varicella Zoster immune globulin if <10
days after exposure. |
The Quarantine Activity Reporting System (QARS), which contains, among other data,
information collected under OMB Control Numbers 0920-0134, 0920-0488, 0920-0821, and
0920-0900, is a web-based and secure electronic system that supports collection of
data for ill persons on inbound or interstate flights and vessels and at land border
crossings; infectious disease threats, and follow-up actions. Currently, HHS/CDC Quarantine
Stations at U.S. ports of entry are using the system to record their daily activities.
All CIs undertaken by HHS/CDC are documented in QARS.
CIs for international flights from January 2010 through December 2015 are summarized
in Table 6. More than half (73.2%) were initiated as a result of tuberculosis cases.
Measles is the next most common disease (20.8%). The remaining 6% are subdivided across
rubella, pertussis, meningococcal [*6938] disease and other diseases. This table also includes CIs undertaken for MERS.
Table 6—International Air Contact Investigations, Average Number of Annual Investigations
and Contacts by Disease, Jan 2010 Through Dec 2015
[QARS data] aDisease | Total investigations | Total contacts | Average investigations per year | Average contacts per year | Percent of total contacts |
Influenza, avian | 0 | 0 | 0.0 | 0.0 | 0.0 |
MERS Coronavirus b | 2 | 270 | 0.3 | 45.0 | 1.7 |
Measles | 94 | 3,381 | 15.7 | 563.5 | 20.8 |
Meningococcal disease | 8 | 9 | 1.3 | 1.5 | 0.1 |
Other | 3 | 97 | 0.5 | 16.2 | 0.6 |
Pertussis | 11 | 18 | 1.8 | 3.0 | 0.1 |
Rabies | 3 | 4 | 0.5 | 0.7 | 0.0 |
Rubella | 17 | 532 | 2.8 | 88.7 | 3.3 |
TB (clinically active) | 318 | 11,928 | 53.0 | 1,988.0 | 73.2 |
Viral hemorrhagic fever | 7 | 53 | 1.2 | 8.8 | 0.3 |
Total | 463 | 16,292 | 77.2 | 2,715 | |
a In May 2011, CIs were discontinued for international outbound flights. To give a
better picture of what CIs will look like under this new protocol, flights from January
2010 to May 2011 have been excluded from the above-reported counts. In addition, CIs
for mumps have been discontinued. Prior to discontinuation, there were approximately
25 contacts per year investigated for mumps. |
b For these CIs, contact information for the entire flight was required. |
In rare instances, a disease is ruled out after a CI has happened. |
HHS/CDC also requests traveler contact data to support contact investigations for
travelers exposed to infectious diseases on interstate flights. The numbers of investigations
and contacts during 2010-15 are summarized in Table 7. In contrast to international
flights, very few contact investigations for tuberculosis were undertaken on interstate
flights, because most interstate flights do not meet the 8-hour time requirement for
tuberculosis contact investigations (Table 5). The majority of contacts were investigated
after exposure to measles cases (76%) followed by MERS (8.4%) and viral hemorrhagic
fevers including Ebola (8.0%).
Table 7—Interstate Air Contact Investigations, Average Number of Annual Investigations
and Contacts by Disease, January 2010 through December 2015
[QARS data]Disease | Total investigations | Total contacts | Average number of investigations per year | Average number of contacts per year | Percent of total contacts |
Measles | 72 | 3033 | 12.0 | 505.5 | 76.1 |
Meningococcal disease | 1 | 1 | 0.2 | 0.2 | 0.0 |
MERS Coronavirus a | 2 | 334 | 0.3 | 55.7 | 8.4 |
Other | 0 | 0 | 0.0 | 0.0 | 0.0 |
Pertussis | 43 | 83 | 7.2 | 13.8 | 2.1 |
Rabies | 3 | 3 | 0.5 | 0.5 | 0.1 |
Rubella | 8 | 172 | 1.3 | 28.7 | 4.3 |
TB (clinically active) | 2 | 40 | 0.3 | 6.7 | 1.0 |
Viral hemorrhagic fever | 4 | 319 | 0.7 | 53.2 | 8.0 |
Total | 135 | 3,985 | 22.5 | 664.2 | |
Notes: |
a For these CIs, contact information for the entire flight was required. |
In rare instances, a disease is ruled out after a CI has happened. |
The numbers of contacts for maritime contact investigations are summarized in Table
8. For maritime investigations, the majority of contacts were investigated for varicella
(~79%) followed by tuberculosis (~13%) and measles (~6%). Most of the varicella and
measles contact investigations were initiated while travelers were still on vessels.
Besides the investigations listed in Table 8, gastrointestinal illness cases on cruise
vessels carrying 13 or more passengers are reported to HHS/CDC’s Vessel Sanitation
Program and cases of Legionnaires’ disease are reported directly to HHS/CDC’s Respiratory
Diseases Branch.
[*6939]
Table 8—Maritime Passenger Data Collection, Average Number of Annual Contacts by Disease
[January 2010-December 2015]Passengers per voyage | Total investigations | Total contacts | Average number of investigations per year | Average number of contacts per year | Percent of total contacts |
Measles | 5 | 288 | 0.83 | 48 | 6.3 |
Meningococcal disease | 3 | 22 | 0.5 | 3.67 | 0.5 |
MERS Coronavirus ** | 0 | 0 | 0 | 0 | 0.0 |
Other | 1 | 9 | 0.17 | 1.5 | 0.2 |
Pertussis | 3 | 14 | 0.5 | 2.33 | 0.3 |
Rabies | 0 | 0 | 0 | 0 | 0.0 |
Rubella | 2 | 26 | 0.33 | 4.33 | 0.6 |
TB (clinically active) | 50 | 585 | 8.3 | 97.5 | 12.8 |
Viral hemorrhagic fever | 0 | 0 | 0 | 0 | 0.0 |
Varicella (chickenpox) a | 206 | 3,627 | 34.3 | 604.5 | 79.3 |
Total | 270 | 4,571 | 45 | 761.8 | 100.0 |
a One CI for varicella involved entire crew of the vessel (1224). |
Contact tracing is most effective at reducing cases of communicable disease at the
early stages of a potential outbreak as soon after initial exposure as possible. Therefore,
if an efficient contact system is not in place when the first ill travelers arrive,
the benefits of contact tracing are greatly diminished.
Contact data requests only occur after a case of serious communicable disease (index
case) is reported in a person who traveled on a commercial airline or vessel while
contagious. This type of situation necessitates identifying and locating travelers
seated near the index case in order to conduct a CI.
At present, HHS/CDC uses a multi-step process to obtain traveler contact information
from airlines. HHS/CDC issues a written order to the airline that requires the airline
to provide HHS/CDC with contact information about the index case and traveler contacts.
The order cites current regulatory language in
42 CFR 71.32(b), as authorized by
42 U.S.C. 264. HHS/CDC requires that the airline provide it with the traveler’s first and last
name, seat number, two phone numbers and email address. HHS/CDC instructs airlines
and vessel operators to provide data when available or to report when data are unavailable.
The time it takes for HHS/CDC to obtain the available traveler contact data can range
from a few hours to a few days. From 2010 through May 2015, about 70% of manifests
from airlines arrived within 3 days of the request, 15% arrived between 3 and 6 days
after a request, 15% arrived after more than six days, and nine requests took more
than a month or were never received by HHS/CDC.
At present, HHS/CDC requests that airlines and vessels provide available traveler
contact data within 24 hours for “urgent” manifest requests. In current practice,
requests for contact data are only considered “non-urgent” for contact investigations
in which travelers had rubella (for which there is no available prophylaxis) or tuberculosis
or for situations in which HHS/CDC is not notified of travelers diagnosed with some
communicable diseases until after a certain amount of time during which prophylaxis
would be effective (e.g., for measles: 6 days). If the analysis is limited to diseases where requests for traveler
contact data are marked “urgent” by HHS/CDC (measles, meningococcal disease, MERS,
viral hemorrhagic fevers, and rabies), performance improved such that 51% arrived
within 24 hours of a request, 33% arrived between 1-3 days after a request, 13% between
3-6 days and only 3% arrived after 6 days. HHS/CDC notes that there may be instances
where CDC may not have included the correct information in a manifest order (e.g., flight number or port of entry). The provision of incorrect flight information may
have caused delay submission in some of the instances cited above.
While HHS/CDC requires that all information be provided upon first order for information,
HHS/CDC has consistently seen that the information provided by a majority of airlines
appears limited to frequent flyer information, or other limited contact information.
Overall, the completeness of data provided by airlines varied such that airlines generally
fell into two categories. Some airlines always provided only the passenger name and
seat number. Other airlines would provide some additional contact information for
passengers. However, even among these airlines, contact data for some of the passengers
only included names and seat numbers. Considering all requests from 2014, at least
one additional piece of contact information was provided for only about 39% of passengers.
If the sample were restricted to only flights for which any contact information was
provided (1,270 out of 2,411 total passengers), the fraction of passengers with at
least one piece of contact information beyond name and seat number increased from
39% to 73.9%. This contact information would include U.S. address for 41.7% of passengers
and one phone number for 45% of passengers. As a result of HHS/CDC’s use of available
information and technology and its partnerships with other Federal agencies, contact
tracing of exposed travelers can now be accomplished more rapidly than would be possible
if only the contact data provided by airlines were used. However, if airlines or vessel
operators have additional data relative to what is currently provided to DHS, the
efficiency of contact investigations could improve.
HHS/CDC is updating the definition of “ill person” in
42 CFR 70.1 and
71.1 to better facilitate identification of communicable diseases of public health concern
aboard flights and voyages. However, HHS/CDC currently requests that aircraft and
vessels report several of the symptoms included in the revised definition of ill person.
Besides aircraft and vessel operators, quarantine stations also receive illness reports
from U.S. Customs and Border Protection, U.S. Coast Guard, State and local health
departments, and health facilities. These reports are not included in this analysis,
which focuses on reporting during travel.
HHS/CDC has crafted the definition of “ill person” in such a way that it should
[*6940] be understood by non-medically trained crewmembers and used to discern illnesses
of public health interest that HHS/CDC would like to be made aware of according to
42 CFR 70.4 from those that it does not (
e.g., common cold), while more closely aligning the definition with the symptoms reporting
guidelines published by ICAO in
Note 1 to paragraph 8.15 of Annex 9 to the Convention on International Civil Aviation. To further assist flight crewmembers (and vessel crewmembers under part 71) in identifying
individuals with a reportable illness, HHS/CDC provides the following in-depth explanations
and examples of the communicable diseases that such signs and symptoms might indicate.
Note that these explanations also apply to the definition of “ill person” under part
71 and are discussed in the preamble of this final rule.
The current illness reporting requirements for interstate travel are summarized in
42 CFR 70.4 and state that “The master of any vessel or person in charge of any conveyance engaged
in interstate traffic, on which a case or suspected case of a communicable disease
develops shall, as soon as practicable, notify the local health authority at the next
port of call, station, or stop, and shall take such measures to prevent the spread
of the disease as the local health authority directs.” Communicable disease is defined
in
42 CFR 70.1 as “illnesses due to infectious agents or their toxic products, which may be transmitted
from a reservoir to a susceptible host either directly as from an infected person
or animal or indirectly through the agency of an intermediate plant or animal host,
vector, or the inanimate environment.”
Thus, the changes in this final rule would amount to fewer illness reports than may
be anticipated under the current regulation. However, in practice, according to CDC
guidance available at
http://www.cdc.gov/quarantine/air/reporting-deaths-illness/guidance-reporting-onboard-deaths-illnesses.html, the symptoms requested for international and interstate illness reporting are the
same subset. In addition, according to guidance, reports received by HHS/CDC would
be considered sufficient to satisfy the requirement to report to local health departments
since HHS/CDC would coordinate any response activities with the local health department
after receipt of the illness report.
This final rule would align the definition from CDC guidance with regulatory text
by requiring reports of ill travelers with fever and persistent cough, persistent
vomiting, difficulty breathing, headache with stiff neck, decreased consciousness,
travelers appearing obviously unwell, or unexplained bleeding. In practice, the codification
of such guidance may increase costs to some or all airlines and vessel operators who
submit illness reports based only upon symptoms currently identified in
42 CFR 71.1 and not based on HHS/CDC guidance. For illness reports from aircraft, DOT/FAA may
also incur additional costs if the number of illness reports made by aircraft pilots
in command to air traffic control and reported to HHS/CDC via the Domestic Events
Network increases.
For aircraft, the updated definition better aligns with symptoms reporting guidelines
published by ICAO in Note 1 to paragraph 8.15 of Annex 9 to the Convention on International
Civil Aviation. Therefore, HHS/CDC does not anticipate much additional burden on airlines
and vessel operators to report ill travelers during travel.
Although HHS/CDC estimates the net change will be no cost to airline or vessel operators,
it may be possible to examine the potential increase using simple assumptions. Table
9 shows the number of reports by pilots in command during flights and recorded in
HHS/CDC’s Quarantine Activity Reporting System (QARS). These include reports of illness
that fit the illness definition specified in current
42 CFR 71.1, reports based on HHS/CDC’s guidance for airlines and vessel operators, reports made
based on the guidelines in Note 1 to paragraph 8.15 of Annex 9 to the Convention on
International Civil Aviation, or illness reports unrelated to current regulation or
guidance. Such reports can also be subdivided into reports requiring HHS/CDC response
(“response reports”) and reports that HHS/CDC receives, but which do not require an
HHS/CDC response (“info-only reports”). Info-only reports may include symptoms included
in HHS/CDC guidance, but for which the underlying condition can easily be diagnosed
not to be a communicable disease of public health concern (
e.g., influenza-like illness on an aircraft). Info-only reports can also be based on illnesses
not requested by HHS/CDC guidance (
e.g., motion sickness).
Table 9—Total Numbers of Reports Made During Flight by Aircraft Operators, 2011 to
2015
[HHS/CDC QARS data]Year | Category | Based on symptoms included in current regulation | Based on symptoms included in final rule | Reports not based on symptoms included in either current regulation or final rule | Total |
2015 | Info-only Response | 30 33 | 55 22 | 43 15 | 128 70 |
2014 | Info-only Response | 33 19 | 61 36 | 42 12 | 136 67 |
2013 | Info-only Response | 31 21 | 46 25 | 29 4 | 106 50 |
2012 | Info-only Response | 34 12 | 58 18 | 38 2 | 130 32 |
2011 | Info-only Response | 27 25 | 39 29 | 25 13 | 91 67 |
Average, Info-only | 31 | 51.8 | 35.4 | 118.2 |
Average Response | 22 | 26 | 9.2 | 57.2 |
Average, total | 53 | 77.8 | 44.6 | 175.4 |
In addition to illness reports, HHS/CDC receives an average of 10 death reports during
air travel each year. Since death reporting requirements are not changing, these are
not analyzed. |
[*6941]
Table 9 shows that HHS/CDC already receives a number of reports based on symptoms
included in HHS/CDC guidance that will be codified with this final rule. On average,
among the total 175 illness reports per year, about 78 annual reports are based on
symptoms included in the final rule, but not in current regulations compared to 53
reports based on symptoms already listed in current regulations. The remaining 45
reports would include those based on fever alone or based on symptoms not included
either in current regulatory text or in this final rule.
The number of illness reports from master of vessels during voyages is summarized
in Table 10. Compared to the breakdown in reports for aircraft, the vast majority
of illness reports during voyages are for response as opposed to info-only. There
may be greater specificity in reports from cruise vessels because of the presence
of medical officers onboard vessels. On average, there were about 208 reports requiring
follow-up and 10.6 info-only reports each year. In contrast to reports from aircraft,
most of the reporting for vessels pertains to symptoms included in the current regulation
(175 per year) as opposed to those specified in this final rule (32 per year). Very
few reports from vessels (3.4 per year) were based on fever only or based on symptoms
not included in either current regulation or specified in this final rule.
Table 10—Total Numbers of Illness Reports (Excluding Influenza-Like Illness) Made
During Voyage by Masters of Vessels, 2011 to 2015
[HHS/CDC QARS data]Year | Type of report | Based on symptoms included in current regulation | Based on symptoms included in final rule | Reports not based on symptoms included in either current regulation or final rule | Total |
2015 | Info-only Response | 5 179 | 4 21 | 4 1 | 13 201 |
2014 | Info-only Response | 6 168 | 3 21 | 3 12 | 12 201 |
2013 | Info-only Response | 1 145 | 1 48 | 3 11 | 5 204 |
2012 | Info-only Response | 5 167 | 7 19 | 3 1 | 15 187 |
2011 | Info-only Response | 1 196 | 3 32 | 4 19 | 8 247 |
Average, Info-only | 3.6 | 3.6 | 3.4 | 10.6 |
Average Response | 171 | 28.2 | 8.8 | 208 |
Average, total | 174.6 | 31.8 | 12.2 | 218.6 |
In addition to the illness reports reported in the table, HHS/CDC receives about 115
reports of death during maritime travel each year. In addition, HHS/CDC requests,
but not require reporting of influenza-like-illness from cruise vessels (also not
included in above table). |
This section reports the primary steps of CIs for routine diseases:
• A traveler (the index case) is identified as ill either during the flight or voyage
with a reportable illness or after with a notifiable disease. The aircraft pilot in
command or master of vessel may report the illness directly to HHS/CDC. Illnesses
on aircraft may also be reported indirectly to HHS/CDC via air traffic control. The
FAA then passes the report to CDC through the Domestic Event Network. If the report
occurs after travel, a healthcare facility would then report the illness either to
HHS/CDC or public health departments (PHDs).
• If CI criteria are met, HHS/CDC contacts the airlines for
○ a manifest to determine where the index case was seated in relation to other passengers
or crew members,
• HHS/CDC then requests information available from DHS’ databases to verify or obtain
passenger contact information not included in the manifest.
• If data are not available in DHS databases, HHS/CDC will require (as part of the
manifest order) for the airlines to provide any available traveler contact information.
The number of travelers for which contact data will be requested is based on the disease-specific
criteria listed in Table 5.
Once HHS/CDC has the traveler contact information and flight-seating chart, the CI
begins. Current CI procedures are cumbersome, in part because of the difficulties
associated with obtaining traveler contact information. HHS/CDC staff may contact
airlines more than once to obtain traveler contact data including email address, one
or two phone numbers, and address in the United States for U.S. citizens and permanent
residents.
When passenger contact information is delayed or partial, State/local public health
departments are delayed in starting CIs and, depending on the disease, this delay
could make it impossible to prevent illness and/or the transmission of disease. Further,
PHDs could have improved success contacting passengers with more accurate or timelier
data.
The model for estimating the benefits of CIs is: Current number of CIs x (reduction
in HHS/CDC and health department staff time/resources per contact) x value of staff
time.
The rest of this section reports both the quantifiable benefits arising from streamlining
the CI process and a discussion of health benefits. The differential impacts of the
various diseases make it hard to summarize the final rule’s effects given uncertainty
around future probabilities of case(s) of multiple such notifiable disease(s). The
timeliness of contact investigations could also be improved if improvements in illness
reporting led to earlier diagnoses of communicable diseases.
Most air travelers with illness are not identified in flight, but rather seek medical
care and are identified as an [*6942] index case after their travel is completed. Compared to air travelers, maritime travelers
spend more time on vessels during voyages and medical officers may be employed on
cruise vessels.
When communicable diseases are diagnosed after travel, the medical practitioner should
notify HHS/CDC or a PHD if the diagnosed disease is on either the list of quarantinable
communicable diseases or the list of notifiable diseases. If HHS/CDC can draw upon
improved contact information based on the codification of requests for traveler contact
data to aircraft and vessel operators as set forth in this final rule, the risk of
onward disease transmission can be reduced. By contacting ill travelers more quickly,
HHS/CDC may slow the spread and the severity of the outbreak. The benefits therefore
depend on:
• How many infected travelers are expected to enter the United States;
• How many quarantinable or notifiable diseases are detected either on-board the aircraft/vessel
or reported to HHS/CDC by PHDs;
• How many exposed travelers will become ill as a result of exposure during travel;
• How the infection will be transmitted within the U.S. population;
• How effective public health agency contact tracing will be with and without the
final rule.
In addition to improved efficiencies associated with more timely or more complete
provision of traveler contact data by airlines and vessel operators, there may also
be an increase in the number of reports of ill travelers during travel that require
HHS/CDC follow-up. Under the most likely scenario, there will not be a change in these
reports, since the new definition better corresponds to reporting guidelines published
by ICAO in Note 1 to paragraph 8.15 of Annex 9 to the Convention on International
Civil Aviation and current HHS/CDC guidance. However, there may be an increase in
illness reports depending on whether airlines and vessel operators increase reporting
for required rather than recommended symptoms.
The change to the definition of an “ill person” for the purposes of illness reporting
and the codification of HHS/CDC requests from airlines and vessel operators for traveler
contact data may improve HHS/CDC’s ability to respond effectively and mitigate infectious
disease outbreaks. There are a number of intermediate steps between either an illness
report or receiving more complete or timelier traveler data and stopping an infectious
disease outbreak. For example, the travelers exposed to the infectious disease would
have to be contacted by health departments and comply with recommended public health
measures, which could include some form of public health or medical follow up to mitigate
their risk of becoming ill, or self-monitoring/quarantine to mitigate the risk of
transmitting that disease to other individuals.
The amount of time HHS/CDC staff spend per air or maritime contact varies with the
size of the CI because some tasks are CI-specific, such as filling out reports or
obtaining manifests, and some are contact-specific such as determining a specific
traveler’s contact information. The CI-specific labor time costs less per contact
when an investigation includes more contacts,
e.g., a manifest that takes 60 minutes of HHS/CDC staff time to obtain for 2 contacts is
the equivalent of 30 minutes-staff-time-per-contact while the same manifest listing
30 contacts is the equivalent of 2 minutes-staff-time-per-contact. On the other hand,
the traveler-specific time tends to increase-per-contact with less information and
decrease-per-contact with more information.
21 Further, the QARS system used to document and follow up on CIs requires full-time
personnel to maintain the system, pull regular reports, and monitor follow-up of travelers
contacted during CIs. Finally, HHS/CDC has two full-time persons regularly assigned
as liaisons to DHS whose duties include gathering contact information from DHS systems.
Therefore, for HHS/CDC staff time to initiate and follow up on different sized CIs,
to track down traveler contact information from multiple sources, to work with PHDs,
document and report on CIs, update and train in systems, and manage the staff involved
in CIs, a cost of $180 per contact is estimated. This is the equivalent of 2 hours
of a HHS/CDC staff person’s being paid the salary of a GS-13, step 4 plus 100% for
benefits and employee overhead costs (Table 11).
21 Margaret S. Coleman, unpublished data.
For PHD resources, HHS/CDC also estimated a cost-per-contact of $180, which is consistent
with HHS/CDC costs and a recent publication adjusted to 2015 dollars.
22 PHD processes vary greatly from State to State and at the local level within a State.
A couple of examples:
22 Coleman, M.S., Marienau, K.J., Marano, N., Marks, S.M., Cetron, M.S. (2014). “Economics
of United States tuberculosis airline contact investigation policies: a return on
investment analysis.”
TMAID 12(1):63-71.
• One State assigns 2 registered nurses (RNs) who perform 5 CIs or fewer per year
for the entire State another State assigns 3 RNs, a Public Health Service Medical
Officer, a physician, and a data analyst and conducts about 25 CIs a year.
23
23 Personal communication from states to Dr. Margaret S. Coleman 2010.
• When one State receives information about passenger contacts from HHS/CDC, the State
epidemiologist creates several documents to fax to the relevant county health departments,
a team of an epidemiologist and RNs at the county then either call or visit the contacts
if there is an address. But the State epidemiologist will make every effort to locate
travelers even if their final destination is unclear.
24
24 Discussion between Dr. Brian Maskery, Dr. Margaret S. Coleman and State and County
Health Department contacts 11/21/2014.
Finally, different diseases may elicit different levels of response at the PHD level,
with a more rapid response for highly infectious diseases like measles that can be
prevented with timely post-exposure prophylaxis and a more measured response for less
infectious diseases like TB. By using the same cost for HHS/CDC and for PHDs, HHS/CDC
believes the potential reductions in cost from reduced effort for PHDs to locate infectious
disease contacts are conservatively estimated.
Table 11—Cost-per-ContactCDC | PHD |
$180 | $180 |
For some diseases, there is empirical data from which onboard transmission can be
estimated. According to a published analysis of the outcomes of measles contact investigations
(74 case-travelers on 108 flights resulting in 3,399 contacts) in the United States
between December 2008 and December 2011, HHS/CDC could not assign 9% of measles contacts
(322) to a health department due to insufficient contact data. Another 12% of these
contacts (397) were believed to be outside the United States.
25 After HHS/CDC provides contact data to State health departments, HHS/CDC requests,
but does not require health departments to
[*6943] provide data on the outcomes of their attempts to follow-up with travelers. Among
the 2,673 contacts assigned to U.S. public health departments in 2008-11, HHS/CDC
only received outcome data for 1,177 out of the 2,673 assigned contacts. This outcome
data included reports from State health departments that 225 out of the 1,177 assigned
contacts could not be located (19%). Among the 952 contacts for which HHS/CDC received
measles outcome data from health departments, there were 9 lab-confirmed measles cases
(1%). Since there may be reporting bias from health departments (
i.e. health departments would be more likely to report outcome data for contacts that
developed measles than for other exposed travelers that did not develop measles, HHS/CDC
considers a range of measles incidence rates among exposed travelers from 9 cases/2,673
contacts assigned to health departments (0.34%) to 9 cases/952 exposed contacts with
outcome data reported to HHS/CDC (0.95%). This probability could overstate or understate
the true transmission rate depending on the length of the flight and seating configuration.
On the other hand, it may understate the probability if cases were not reported or
occurred overseas.
25 Nelson, K., Marienau, K.J., Schembri, C. and Redd, S. (2013). “Measles transmission
during air travel, United States.” Travel Medicine and Infectious Disease (2013) 11,
81e89 11: 81-89.
The majority of travelers exposed to measles on aircraft (~74%) had pre-existing immunity
based on past measles immunization, past measles illness, or being born prior to 1957
and thus likely to have measles immunity even if they do not recall experiencing the
disease.
26 Among the 952 exposed travelers, 8 cases occurred in the 247 contacts (3.2%) without
known pre-existing immunity compared to 1 case in the 705 contacts with past history
of vaccination or measles illness (0.1%). The median age of measles cases in exposed
air traveler contacts was 1.6 years.
26 Nelson, K., Marienau, K.J., Schembri, C. and Redd, S. (2013). “Measles transmission
during air travel, United States.” Travel Medicine and Infectious Disease (2013) 11,
81e89 11: 81-89.
Intervention by public health departments mitigates the risk of measles transmission
in two ways. First, exposed travelers without measles immunity may be offered voluntary
post-exposure prophylaxis with measles-containing vaccine (within 72 hours) or immune
globulin (within 6 days),
27 which can prevent onset of disease, halting outbreaks before they begin. Under the
status quo, relatively few exposed travelers receive post-exposure prophylaxis (just
11 out of 248 travelers with no history of measles immunization or infection). Second,
exposed travelers would be counseled by health departments to self-isolate and seek
treatment if they started to experience symptoms consistent with measles onset. For
example infants exposed during travel and too young to be vaccinated could arrange
for special precautions if they visit a pediatrician after becoming ill with measles-like
symptoms to minimize the transmission to other unvaccinated infants. Both activities
will limit the possibility of measles transmission to family members or others in
the community. The attack rate for measles is estimated to be 90%, but the high background
immunization rate and high efficacy of measles vaccine attenuates the burden of measles
outbreaks in the United States.
27 Nelson, K., Marienau, K.J., Schembri, C. and Redd, S. (2013). “Measles transmission
during air travel, United States.” Travel Medicine and Infectious Disease (2013) 11,
81e89 11: 81-89.
In summary, the potential size of a measles outbreak occurring depends on:
• The number of persons contacted by the infectious measles patient
• Background immunity among persons contacted
○ Survey estimates have shown considerable heterogeneity in background vaccination
rates such that 80% of unvaccinated children live in counties comprising 40% of the
total population.
28
28 Smith P, Marcuse E, Seward J, Zhao Z, WA O. Children and Adolescents Unvaccinated
Against Measles: Geographic Clustering, Parents’ Beliefs, and Missed Opportunities.
Public Health Rep. 2015;5:485-504.
For tuberculosis, it is difficult to estimate the transmission rate on an aircraft
or vessel. A modeling study suggests that the risk of infection is about 1/1000 on
an 8.7 hour flight and that persons seated closer to the index case are at greater
risk of infection.
29 Only 5-10% of persons infected with the bacteria
Mycobacterium tuberculosis will go on to develop active, infectious disease and the risk of progression is greatest
within the first two years after infection.
30
29 Ko G, Thompson KM, Nardell EA. Estimation of tuberculosis risk on a commercial airliner.
Risk Anal 2004;24:379e88.
30 Marienau KJ, Cramer EH, Coleman MS, Marano N, Cetron MS. Flight related tuberculosis
contact investigations in the United States: comparative risk and economic analysis
of alternate protocols. Travel Med Infect Dis. 2014;12(1):54-62.
An analysis of the epidemiology and outcomes of HHS/CDC-led flight-related tuberculosis
contact investigations conducted in the United States from January 2007 to June 2008
examined 131 case-travelers and 4,550 passenger-contacts.
31 Among 3,375 (74%) passenger-contacts whose information was provided to health departments,
HHS/CDC received results for 861 (26%). HHS/CDC found that 103/861 (12%) had a previous
history of a positive TB screening test result or treatment for latent tuberculosis
or active disease and were not re-tested. Of the remaining 758 passenger contacts,
182 (24%) tested positive. The majority of travelers with data about TB risk factors
(other than exposure to cases during air travel) had at least one risk factor (130/142
or 92%). Risk factors included having been born or lived in a country with high TB
prevalence (prevalence >100 per 100,000 population). Although passenger-contacts with
risk factors were more likely to have pre-existing latent tuberculosis infection,
the authors could not exclude the possibility that infection was acquired during the
flights when the travelers were exposed. Furthermore, because outcomes data were reported
for only 26% of passenger contacts forwarded to U.S. health departments (19% of all
passenger contacts) the precise determination of in-flight transmission risk of
M. tuberculosis was not feasible.
32
31 Marienau KJ, Burgess GW, Cramer E, et al. Tuberculosis investigations associated
with air travel: US Centers for Disease Control and Prevention, January 2007-June
2008. Travel Med Infect Dis 2010;8:104e12.
32 Marienau KJ, Burgess GW, Cramer E, et al. Tuberculosis investigations associated
with air travel: US Centers for Disease Control and Prevention, January 2007-June
2008. Travel Med Infect Dis 2010;8:104e12.
The results from this investigation were used in a cost-effectiveness study to estimate
the return on investment for tuberculosis CIs. The authors examined a range of latent
tuberculosis prevalence rates among exposed travelers that varied between 19% and
24% for two different HHS/CDC CI protocols for flight-related TB investigations. The
return on investment was calculated based on the likelihood that travelers with latent
tuberculosis infection would initiate and complete a treatment regimen to clear the
infection, the average cost of tuberculosis treatment, a tuberculosis case fatality
rate of 5% and a conservative value of statistical life estimate of $4.2 million (in
2009 USD) to account for the value of mortality risk reduction from avoided tuberculosis
disease. The return on investment depended on the probability assumed for persons
with latent TB infection to develop active disease (5-10%) and variation in the costs
to health departments to locate exposed travelers ($28 to $164). Using the expected
latent tuberculosis prevalence rate of 19% in travelers identified for contact investigations
on flights and a health department cost per contact of $164, the return on investment
was estimated to
[*6944] vary between $1.01 and $3.20. The return on investment formula was calculated based
on (Expected benefits-Expected costs)/Expected costs. Thus, for each $1 in Federal
and State resources spent on contact investigations and offering treatment to persons
infected with latent tuberculosis infections would result in benefits in excess of
costs equal to $1.01 to $3.20
3334 on average. At the upper bound latent tuberculosis prevalence estimate (24%), the
return on investment was estimated to vary between $1.35 and $3.92.
33 Coleman M, Marienau K, Marano N, Marks S, Cetron M, Dis TMI. Economics of United
States Tuberculosis Airline Contact Investigation Policies. Travel Medicine and Infectious
Disease. 2014;12:63-71.
34 Marienau KJ, Burgess GW, Cramer E, et al. Tuberculosis investigations associated
with air travel: US Centers for Disease Control and Prevention, January 2007-June
2008. Travel Med Infect Dis 2010;8:104e12.
There is also empirical data for SARS infections occurring on an aircraft. A study
reported that 37 infections resulted from 40 flights with infectious passengers on
board. Of the 40 flights, four have documented aircraft sizes. They average 127 passengers
per plane.
35 Therefore the on board transmission rate could be estimated to be 0.73% among all
travelers. In comparison, there is no evidence of transmission of MERS Coronavirus
or viral hemorrhagic fevers during travel on aircraft or vessels. However, there have
not been enough observations to determine that there is no risk.
35 Mangili A, Gendreau MA. Transmission of infectious diseases during commercial air
travel. Lancet. 2005;365:989-96.
For the remainder of the diseases, empirical data does not exist. Like measles, immunizations
are recommended to prevent pertussis, rubella, and meningococcal disease. Since meningococcal
conjugate vaccine was more recently added to the United States vaccination schedule,
it is likely that background immunity is much lower relative to measles, rubella or
pertussis.
In the absence of data for some diseases, the infection rate of measles is used to
estimate the infection rates by using the ratio of basic reproduction numbers (R
0). The basic reproduction number is a measure of disease infectiousness. Specifically,
it is an estimate of new infections in a completely susceptible population. For example,
rubella has an R
0 of 9 to 10 while measles has an R
0 of 15 to 17.
36 The infection rate of measles is multiplied (0.0034 to 0.0095) by the ratio of the
average basic reproductive numbers (9.5/16) to arrive at a transmission rate (0.002
to 0.006) for rubella on airplanes. This rate is approximately 60% of the rate for
measles. The estimated transmission rates for some diseases are reported in Table
12. The exceptions are for meningococcal disease and tuberculosis. For meningococcal
disease, the risk of transmission in household contacts 0.002 to 0.004
37 is used in the absence of other data and taking account that CIs are only performed
for travelers sitting adjacent to the index case or in the event of other known exposures.
For tuberculosis, the probability that exposed travelers have latent tuberculosis
38 (19%-24%) is used, although infection may have occurred prior to air travel. For
the purposes of evaluating the economic impact of tuberculosis investigations, it
does not matter if travelers were infected during travel or before.
36 Anderson RM. The concept of herd immunity and the design of community-based immunization
programmes. Vaccine. 1992;10(13):928-35.
38 Marienau KJ, Burgess GW, Cramer E, et al. Tuberculosis investigations associated
with air travel: US Centers for Disease Control and Prevention, January 2007-June
2008. Travel Med Infect Dis 2010;8:104e12.
Table 12—Estimated Transmission Rate on Plane for Exposed TravelersDisease | R0 | Estimated transmission rate on aircraft to exposed passengers |
| | Lower bound | Upper bound |
Diphtheria (quarantinable) | 11 to 14 | 0.0026 | 0.0074 |
Measles (non-quarantinable) | 15 to 17 | 0.0034 | 0.0095 |
Meningococcal Disease (non-quarantinable) | NA | <2/1000 | <4/1000 |
Pertussis (non-quarantinable) | 4 to 5 | 0.001 | 0.003 |
Rubella (non-quarantinable) | 9 to 10 | 0.002 | 0.006 |
TB (quarantinable) | NA | 0.19 | 0.24 |
The number of potential contacts for each disease can be multiplied by the estimated
transmission rate by disease in Table 12 to generate a rough estimate of the annual
number of cases among traveler contacts. These numbers of contacts for each disease
are summarized in Tables 6 and 7 for interstate and international CIs respectively.
Contact investigations on vessels are excluded for this analysis. Based on this analysis,
tuberculosis (19 to 48) and measles cases (3.6 to 10.1) are the most likely diseases
that will be diagnosed among contacts exposed during travel (Table 13). Tuberculosis
contact investigations only occur for international flights with the very rare exception
of a domestic flight with a duration greater than 8 hours. The numbers of contacts
and outcomes are much more uncertain for other diseases. The number of tuberculosis
cases are adjusted from the number of contacts with tuberculosis by assuming that
only 5% (lower bound) to 10% (upper bound) of infected contacts will go on to develop
clinical disease.
39
39 Coleman M, Marienau K, Marano N, Marks S, Cetron M, Dis TMI. Economics of United
States Tuberculosis Airline Contact Investigation Policies. Travel Medicine and Infectious
Disease. 2014;12:63-71.
For viral hemorrhagic fevers and MERS, there is no evidence of transmission, but there
have not been very many observations.
[*6945]
Table 13—Annual Estimated Number of Cases Among International Passenger Contacts by
DiseasePassengers per flight | Number of contacts | Expected incidence among contacts (lower bound) | Expected incidence among contacts (upper bound) | Expected number of new cases (lower bound) | Expected number of new cases (upper bound) |
MERS Coronavirus (quarantinable) | 101 | Insufficient data |
Measles (non-quarantinable) | 1,069 | 0.0034 | 0.0095 | 3.6 | 10.1 |
Meningococcal Disease (non-quarantinable) | 1.7 | 0.00200 | 0.00400 | 0.0033 | 0.0067 |
Pertussis (non-quarantinable) | 16.8 | 0.001 | 0.003 | 0.02 | 0.04 |
Rubella (non-quarantinable) | 117 | 0.002 | 0.006 | 0.2 | 0.7 |
TB a (quarantinable) | 1,995 | b 0.19 | b 0.24 | c 18.9 | c 47.90 |
Viral Hemorrhagic Fever (quarantinable) | 62.0 | Insufficient data |
Total | 3,362 | | | 22.8 | 58.7 |
a For tuberculosis, travelers contacts are typically found to test positive for infection,
but do not have active disease. |
b These probabilities indicate the likelihood that a contact will test positive for
infection. |
c The expected numbers of cases adjust for the finding that only 5-10% of individuals
that test positive for infection will go on to develop clinical disease. |
These estimates of cases may be a lower bound, because potential cases resulting from
flights in which contact investigations were not performed are not included. Especially
for tuberculosis cases, many international travelers may return to their home countries
before seeking treatment and such cases may not lead to contact investigations if
HHS/CDC is not informed.
Since the final rule does not change the timeframe or amount of data requested from
airlines or vessel operators, the most likely economic impact is a small change in
the amount of effort for airlines to provide more complete and timely information.
To the extent that airlines would respond more quickly or with additional data, it
would require some airline information technology staff to expedite requests or to
search in more depth for available data. HHS/CDC estimates this may require one hour
of staff time per request. HHS/CDC has no way to predict how much more complete, timely,
or accurate contact from airlines would become as a result of this final rule. On
average, HHS/CDC acted upon 77 requests per year to airlines for international traveler
contact data between 2010 and 2015 (Table 6). In addition, HHS/CDC made 22.5 requests
per year for interstate traveler data (Table 7) over the same period. There were 45
contact investigations per year among travelers on vessels (Table 8); however, most
of these were undertaken before travelers disembarked vessels in which case contact
data could be collected directly from exposed travelers as part of the investigation.
The number of maritime contact investigations requiring manifest requests after disembarkation
is estimated to be less than 10 per year.
Overall, including international air and maritime activities, the estimated number
of contact data requests after disembarkation was estimated at 100 to account for
the fact that HHS/CDC sometimes requests traveler contact data for infectious disease
events prior to confirmed diagnoses. On occasion, it turns out that travelers are
not infected with diseases that require a public health response. This rounding up
should also account for a year in which there is a significant increase in the number
of contact investigations among exposed air or maritime travelers. HHS/CDC notes the
manifest order process for interstate flights is not codified in the final rule. The
data is provided here for completeness.
The average wages for computer and information systems managers (occupation code 11-3021)
reported in the Bureau of Labor Statistics, May 2015 Occupational Employment Statistics
40 were $63.27 per hour. On average, under the baseline, HHS/CDC assumes that it would
require 6 hours of work by airlines to search databases and provide data. For the
final rule, HHS/CDC assumes that a management-level computer specialist will spend
additional time to provide the best possible contact data for potentially exposed
travelers. The base salary is multiplied by an overhead multiplier of 100% to account
for non-wage benefits and other overhead costs for supporting each employee (Table
14). The lower bound estimate ($0) is no change from current practice, while the upper
bound estimate assumes 2 hours of time instead of one ($25,308). These costs are applied
to an estimated 100 manifest requests per year.
Table 14—Estimate of Costs for Airlines and Vessel Operators To Improve Compliance
With HHS/CDC Requests for Traveler Contact Data, 2015 USD | Average number of manifest requests per year | Increased effort to provide more complete or timelier passenger contact data (hrs.) | Average hourly wage rate of IT staff (2015 USD) | Overhead multiplier (%) | Total cost |
Baseline | 100 | 6 | $63.27 | 100 | $75,924 |
Best estimate | 100 | 1 | 63.27 | 100 | 12,654 |
Lower bound | 100 | 0 | 63.27 | 100 | 0 |
Upper bound | 100 | 2 | 63.27 | 100 | 25,308 |
When reports are received, public health officers at Quarantine Stations perform case
assessments, may request follow-up information, and may consult with HHS/CDC medical
officers to determine if additional action such as a contact investigation, onboard
response, or notification to State and local health departments is warranted. Under
one assumed upper bound scenario, the change in the definition of “ill person” included
in the final rule could result in a 100% increase in the number of info-only reports
from airlines and a 25% increase from vessels. On average, there are 129 info-only
reports for aircraft and vessels each year and these increases would correspond to
an annual increase of 119 info-only reports on aircraft and 3 info-only reports on
vessels (Table 15). If the average time for each report is estimated to be 2 minutes
for aircraft pilots in command or masters of vessels to make the report, 10 minutes
for a traveler to discuss the illness with public health officer, and 60 minutes for
HHS/CDC to document the info-only report, the estimated cost of the additional reports
can be estimated based on the opportunity cost of time for each type of personnel.
In addition to the time required for aircraft pilots in command and masters of vessels
to make reports, the personnel in the Department of Transportation’s Federal Aviation
Administration (DOT/FAA) may incur additional costs to relay reports of suspected
cases of communicable disease received by air traffic control to CDC through the Domestic
Events Network. The amount of DOT/FAA staff time is estimated at 26 minutes for a
government employee at GS-level 15, step 6 based in Washington, DC. In reality, there
would be three DOT/FAA employees involved including 1 GS-15/16 level employee at air
traffic control (10 minutes), 1 GS-15 level employee at the Domestic Events Network
(10 minutes), and 1 GS-14 level employee at DOT/FAA’s Washington Operations Center
Complex (6 minutes).
41
41 Personal communication between Dr. Brian Maskery and DOT/FAA.
For aircraft pilots in command or masters of vessels (occupation codes 53-2011 and
53-5021) and travelers (average across all occupations code 00-0000), their opportunity
cost is estimated from Bureau of Labor Statistics, May 2015 Occupational Employment
Statistics
42 based on the average salary of aircraft pilots or copilots ($57.35 per hour), traveler
($23.23 per hour) or vessel captain, mate, or pilot ($39.95 per hour). For HHS/CDC
employees, the average wage rate is based on the Federal government’s general salary
scale for a GS-12, step 5 employee based in Atlanta, GA). Base salaries are multiplied
by an overhead multiplier of 100% to account for non-wage benefits and other overhead
costs for supporting each employee. Travelers do not have overhead costs. The annual
quantified costs of 122 additional info-only reports would be $17,471.
Table 15—Changes in Numbers of Info-Only Reports and Associated Costs for the Final
Rule Upper Bound, 2015 USDEmployee type | Change in number of info-only reports | Amount of time required per report (min) | Estimated wage rate (2015 USD per hr.) | Overhead multiplier (%) | Estimated cost |
Aircraft: | | | | | |
Aircraft Pilots or Copilots | 119 | 2 | $57.35 | 100 | $455 |
CDC employee | 119 | 60 | 39.83 | 100 | 9,480 |
DOT/FAA employees | 119 | 26 | 70.57 | 100 | 7,278 |
Traveler | 119 | 10 | 23.23 | 0 | 461 |
Air total | | | | | 17,213 |
Vessels: | | | | | |
Air or maritime conveyance officer | | | | | |
Captains, Mates, and Pilots of Water Vessels | 3 | 2 | 39.95 | 100 | 8 |
CDC employee | 3 | 60 | 439.83 | 100 | 239 |
Traveler | 3 | 10 | 23.23 | 0 | 12 |
Maritime total | | | | | 259 |
Total costs, aircraft and vessels | | | | | 17,471 |
Notes: Assumes 100% increase in info-only reports from airlines and 25% from vessel operators. |
[*6947]
Besides the possible change in costs of info-only reports, the other potential change
would be an increase in the number of reports that require HHS/CDC follow-up. Under
the most likely scenario, there will not be a change in these reports since the new
definition better corresponds to HHS/CDC guidance and to reporting guidelines published
by ICAO in Note 1 to paragraph 8.15 of Annex 9 to the Convention on International
Civil Aviation. However, there may be an increase in the number of reports requiring
a response. Under this scenario, there may be an increase in costs for air or masters
of vessels to report illnesses. The upper bound increase in reports requiring response
is assumed to be 50% of the average annual illness reports from airlines and a 10%
increase from vessels (refer to Tables 10 and 11 for baseline number of reports):
29 reports per year on aircraft and 21 reports per year on vessels. HHS/CDC assumes
that the time required to submit illness reports and for DOT/FAA staff to relay reports
requiring responses is the same as for info-only reports (2 minutes for pilots in
command and masters of vessels and 26 minutes for DOT/FAA to relay reports, Table
16). Further, HHS/CDC assumes that travelers could spend up to 60 minutes talking
to HHS/CDC and/or State and local public health officers for reports requiring response.
The upper bound estimate of total costs associated with the increase in the number
of illness reports requiring response is estimated to be $3,102.
There would likely be no change or a decrease in HHS/CDC costs because earlier reporting
would lead to a more efficient HHS/CDC response relative to an alternative in which
the illness was not reported during travel, but instead was later reported by a public
health department to HHS/CDC. In addition, the public health response to the illness
would likely be more efficient because exposed travelers could be contacted earlier.
In rare situations, such travelers may potentially be informed of their potential
exposure at the gate after disembarking the aircraft or vessel. Such actions should
not result in significant delays by holding travelers on board.
HHS/CDC did not include any training costs because the change in the “ill person”
definition in this final rule is consistent with the internationally recognized and
accepted illness reporting guidelines published by ICAO for international travelers
and represents a reduced burden compared to the previous illness reporting regulations
for interstate travelers.
Table 16—Changes in Annual Numbers of Reports Requiring Response and Associated Costs
for the Final Rule Upper Bound, 2015 USDEmployee type | Change in number of reports | Amount of time required per report (min) | Estimated wage rate (2015 USD per hr.) | Overhead multiplier (%) | Estimated cost (2015 USD) |
Aircraft: | | | | | |
Aircraft Pilots or Copilots | 29 | 2 | $57.35 | 100 | $111 |
CDC employee | 29 | 0 | 39.83 | 100 | 0 |
DOT/FAA employee | 29 | 26 | 70.57 | 100 | 1,774 |
Traveler | 29 | 60 | 23.23 | 0 | 674 |
Total | | | | | 2,558 |
Vessels: | | | | | |
Captains, Mates, and Pilots of Water Vessels | 21 | 2 | 39.95 | 100 | 56 |
CDC employee | 21 | 0 | 39.83 | 100 | 0 |
Traveler | 21 | 60 | 23.23 | 0 | 488 |
Total | | | | | 544 |
Total | | | | | 3,102 |
Notes: Assume 50% increase in air illness and a 10% increase in maritime illness reports
requiring response (international and interstate). |
There may also be a one-time cost associated with updating training to reflect the
new regulatory text. As noted above, HHS/CDC reiterates that the change to regulatory
text is a codification of HHS/CDC guidance and better aligns with international guidance
(Note 1 to paragraph 8.15 of Annex 9 to the Convention on International Civil Aviation).
Further for interstate travel, these changes result in relaxed illness reporting compared
to status quo regulatory text. Thus any airlines using either ICAO or HHS/CDC guidance
to support training efforts for illness reporting should not need to change training
materials. At most, it may be necessary to clarify that some symptoms that were previously
requested are now required. However, for some airlines or vessel operators, it may
be necessary to revise training materials.
The cost of training was estimated based on the number of pilots and flight attendants
and their average wage rates as reported in the Bureau of Labor Statistics, May 2015
Occupational Employment Statistics.
43 HHS/CDC assumes that the opportunity cost of employee time spent in training would
be the primary cost as opposed to the cost of developing training materials. As an
upper bound, HHS/CDC assumed the cost of training could be estimated based on assuming
that all employees would require 10 minutes of training to summarize the changes.
As noted above, since this change aligns regulatory text with existing HHS/CDC and
ICAO guidance documents, this change may not result in a new training requirement
for all airlines since some presumably already use HHS/CDC guidance in training. This
10 minute estimate does not necessarily mean all 230,000 pilots and flight attendants
each require 10 minutes of training. For example, 50% of each could require 20 minutes
of training, while the other 50% may already conduct training in accordance with either
CDC or ICAO guidance. The total cost of the one-time change in training is about $3.1
million. If this cost is annualized over 10 years, the average annual cost depends
on the discount rate assumed and varies from $313,000 per year (7% discount rate)
to $416,000 (0% discount rate). These
[*6948] results are summarized in Table 17. These costs (3% discount rate) are added to the
upper bound cost estimate for illness reporting. The lower bound and best estimates
are $0 since the changes to the definition better align with existing CDC and ICAO
guidance.
Table 17—Estimated Costs for One-Time Training About Changes in Illness Reporting
for Airlines, 2015 USDEmployee type | Number of employees | Amount of time required for training per employee (minutes) | Estimated wage rate (2015 USD per hr.) | Overhead multiplier (%) | Estimated cost or benefit (2015 USD) |
Aircraft Pilots or Copilots | 121,110 | 10 | 57.35 | 100 | 2,315,220 |
Flight attendants | 108,510 | 10 | 22.46 | 100 | 812,465 |
Total | | | | | 3,127,685 |
Annualized cost over 10-year time horizon | 3% discount rate | $355,981 | 0% discount rate | $416,179 | 7% discount rate | $312,768 |
The monetized annual costs resulting from the change in the definition of “ill person”
are summarized in Table 18. The benefits in regard to reductions in communicable disease
transmission are summarized in a subsequent section.
Table 18—Best Estimate, Lower Bound and Upper Bound of the Changes in Annual Monetized
Benefits and Costs as a Result of the Change to the Reportable Illness Definition,
2015 USD | Best estimate | Lower bound | Upper bound |
Costs |
Final Rule: | | | |
Aircraft | $0 | $0 | $375,751 |
Vessels | 0 | 0 | 802 |
Total | 0 | 0 | 376,554 |
The total costs of the final rule are summarized in Table 19 and include the costs
of the change to the definition of an “ill person” and the codification of the requirement
for airlines to provide passenger contact data for the final rule.
Table 19—Total Costs and Benefits Resulting From Codification of Traveler Data Collection
(71.4 and 71.5) and Change to Definition of “Ill Person” (70.1 and 71.1) | Best estimate | Lower bound | Upper bound |
Costs |
Final Rule: | | | |
71.4 and 71.5 Passenger data collection | $12,654 | $0 | $25,308 |
70.1 and 71.1 Change in definition of an “ill person” | 0 | 0 | 376,554 |
Total costs | 12,654 | 0 | 401,862 |
This section reports the benefits that HHS/CDC anticipates from implementation of
the final rule in avoiding the costs incurred annually for CIs of infectious diseases.
The model for estimating the benefits of CIs is: Current number of CIs x (reduction
in HHS/CDC and health department staff time/resources per contact) x value of staff
time.
HHS/CDC obtained the total number of contacts traced (2,715 per year, Table 6) for
all diseases reported on international flights. International flight data were extracted
for this analysis because the codification of the requirements to provide timelier
and more complete contact data is limited to international arrivals. In comparison,
HHS/CDC requests contact information for approximately 664 contacts per year on interstate
flights (Table 7). HHS/CDC also supports contact investigations affecting an average
of 762 contacts per year for illnesses on board vessels (Table 8); however, many of
these investigations occur before travelers disembark vessels. By limiting the analysis
to contacts on international flights, HHS/CDC conservatively estimates the potential
benefits associated with this final rule. HHS/CDC multiplied the average annual number
of contacts on international flights by the cost-per-contact for HHS/CDC and PHDs
(Table 11) to estimate the costs of CIs under the current baseline.
To estimate the benefits (Tables 20 and 21), HHS/CDC assumed a percent reduction in
staff time for CIs at HHS/CDC (0-3%) and PHD levels (0-2%) [*6949] based on internal conversations with personnel directly involved in the CI process.
The reduction in staff time that would result from implementation of this final rule
would arise from the ability of HHS/CDC to have a better starting point with which
to provide traveler contact data to State and local health departments as a result
of the receipt of more complete and timely traveler contact data from airlines. The
impact of codification is expected to be limited and would depend on instances in
which airlines have more data than what is currently provided to DHS. Better data
would improve HHS/CDC’s ability to transmit information to destination States more
quickly and for States to contact exposed travelers earlier. This would allow States
to start their investigations more quickly, contact more travelers faster to conduct
public health assessments and potentially offer preventive medications or vaccines
in a more timely fashion or to recommend self-monitoring to mitigate onward transmission.
In addition, it would be less likely that HHS/CDC would send incorrect contact data
to States. With all of the preceding factors in mind, HHS/CDC estimated that the final
rule would reduce labor time by between 0% to 3% at HHS/CDC, and 0% to 2% at PHDs.
The higher percentage of avoided costs at HHS/CDC reflect reduced efforts by HHS/CDC
to search for accurate contact data for travelers due to untimely or inaccurate data.
The lower percentage of avoided costs at PHDs reflects a more diffuse (e.g., multiple local PHDs in a State) infrastructure and the more labor-intensive tasks
of following up on individuals. These estimates are small because the change is a
clarification and codification of a current practice authorized under broad statutory
and regulatory authority rather than a new regulatory requirement. In addition, the
change to the definition of “ill person” may lead to the earlier diagnoses of some
travelers with communicable disease, which may lead to earlier and more efficient
public health responses.
HHS/CDC annual costs to engage in international air, interstate air, and maritime
CIs are about $745,000 or roughly the equivalent of 3.8 HHS/CDC full-time employees
(FTEs) at the wage level of GS-13, step 4 plus benefits and overhead (Table 21). The
final rule should have the greatest effect on the international air CIs. The annual
reduction in contact tracing costs from implementing the final rule (Table 22) for
HHS/CDC ranged from $0 to $14,661 based on a 0-3% reduction in effort on international
CIs. For PHDs, the reduction in costs ranged from $0 at the lower bound to $9,774
at the upper bound (Table 22).
Table 20—Annually for HHS/CDC and PHD: Baseline Costs | Annual number contacts | HHS/CDC | PHD costs | Total costs |
HHS/CDC and PHD Baseline Costs (Current Practice) |
International air contacts | 2,715 | $488,700 | $488,700 | $977,400 |
Interstate air contacts | 664 | 119,520 | 119,520 | 239,040 |
Maritime contacts | 762 | 137,160 | 137,160 | 274,320 |
Total baseline costs | 4,141 | 745,380 | 745,380 | 1,490,760 |
Viral hemorrhagic fever, MERS, and SARS contacts | 163 | 29,340 | 29,340 | 58,680 |
Table 21—Annual For HHS/CDC and PHDs: Baseline Costs, Final Rule Costs, Benefits With
the Final Rule (Number Contacts Annualized From January 2010 to December 2015), 2015
USD
HHS/CDC and PHD Baseline Costs (Current Practice) |
| Annual number contacts | HHS/CDC | PHD |
International contacts | 2,715 | $488,700 | | |
HHS/CDC and PHD Costs With the Final Rule |
| Estimated Costs for HHS/CDC After Efficiency Improvement with Final Rule | Estimated Costs for PHDs After Efficiency Improvement with Final Rule |
| 0%, Lower bound | 3%, Upper bound | 0%, Lower bound | 2%, Upper bound |
International contacts costs assuming reduction in time (2,715) | $488,700 | $474,039 | $488,700 | $478,926 |
Benefits From Implementing the Final Rule |
| HHS/CDC 0% and 3% Reduction in effort | PHD (0% and 2% Reduction in effort) |
Benefits (Reduced costs) | $0 | $14,661 | $0 | $9,774 |
The best estimate of benefits are the midpoint of the lower bound and upper bound
estimates for both HHS/CDC and PHDs ($12,218). The lower bound ($0) and upper bound
estimates ($24,435) for both entities are also reported in Table 22.
[*6950]
Table 22—Best Estimate, Lower Bound and Upper Bound of Benefits From Increased Efficiencies
for HHS/CDC and PHDs To Conduct Contact Investigations With Provision of Better Data
From Airlines (Final Rule), 2015 USD | HHS/CDC benefits | PHD benefits | Total |
Best estimate | $7,331 | $4,887 | $12,218 |
Lower bound | 0 | 0 | 0 |
Upper bound | 14,661 | 9,774 | 24,435 |
The total annual monetized benefits by stakeholder from the potential reduced effort
for contact investigations are summarized in Table 23.
Table 23—Best Estimate, Lower Bound and Upper Bound of Benefits From Increased Efficiencies
for HHS/CDC and PHDs to Conduct Contact Investigations With Provision of Better Data
From Airlines, 2015 USD | HHS/CDC benefits, USD | PHD benefits, USD | Airlines, USD | Total |
Best estimate | $7,331 | $4,887 | $0 | $12,218 |
Lower bound | 0 | 0 | 0 | 0 |
Upper bound | 14,661 | 9,774 | 0 | 24,435 |
On average, HHS/CDC identified 564 travelers exposed to measles cases on international
flights during 2010-2015 (Table 6). The final rule may affect the cost for health
departments to implement public health measures in two ways: (1) Health departments
may contact exposed travelers more quickly and (2) health departments may be able
to contact a higher percentage of exposed travelers. For the first set of travelers
that are contacted earlier with the final rule than under the status quo, the cost
to both the contacted travelers and to health departments should be less than under
the status quo. For measles contacts, earlier follow-up with public health departments
should lead to more travelers being offered voluntary measles vaccines within 72 hours.
This would potentially reduce the cost of following up with exposed travelers at which
time health departments could offer to administer immune globulin or health departments
may monitor travelers that have been located after the 72-hour window in which measles
vaccination would reduce their risk of developing symptomatic measles. At present,
very few travelers receive post-exposure prophylaxis, 11/248 or 4.4%.
44 In addition, health departments have implemented quarantine (usually voluntary) for
unvaccinated, high risk measles exposures.
45 HHS/CDC notes that measles is not a quarantinable communicable disease under Federal
regulations, but may be quarantinable under a State’s authorities. HHS/CDC also notes
that measles vaccine is recommended for all persons lacking immunity. Thus, the costs
of vaccination for exposed travelers as part of the contact investigation may have
been incurred at a later date if travelers’ health care providers recommended measles
vaccination at a more routine health care visit in the future.
46 However, to be conservative, HHS/CDC includes the full additional cost to administer
such vaccines to persons contacted.
44 Nelson K, Marienau K, Schembri C, Redd S. Measles transmission during air travel,
United States. Travel Medicine and Infectious Disease (2013) 11, 81e89. 2013;11:81-9.
Among the contacts, HHS/CDC estimates that approximately 25% (141 contacts per year)
cannot be located by public health departments (Table 24), either because HHS/CDC
cannot assign the contacts to health departments or because the information provided
by HHS/CDC is not sufficient to enable health departments to locate contacts after
assignment from HHS/CDC. Among these contacts, HHS/CDC assumes that 10% of all contacts
(56) are not located because HHS/CDC cannot assign contacts to State health departments
due to insufficient data. For these contacts, health departments would not incur any
contact tracing costs because such contacts would not be assigned. HHS/CDC assumes
a 15% improvement from baseline as a result of this final rule (Table 24). This would
result in 8.5 additional contacts per year assigned to health departments for contact
tracing. As shown in Table 11, HHS/CDC estimates that health departments incur an
estimated cost of $180 per contact. The marginal cost incurred from this final rule
for additional measles contacts assigned to health departments would be $180 x 8.5
= $1,530 per year (Table 25).
Table 24—Estimated Marginal Improvement in the Numbers of Measles Contacts Who Could
Be Treated With Final RuleDescription | n | Reference |
Average contacts per year for measles, (a) | 564 | Table 6. |
Estimated number of contacts for which HHS/CDC cannot assign to a health department,
(b) = 10% x (a) | 56 | Nelson et al. 2013.47 |
Estimated improvement in HHS/CDC’s ability to assign contacts to health department
(c) = 15% x (b) | 8.5 | Assumption. |
Numbers of people who are not currently contacted due to lack of contact information,
(d) = (a) x 25% | 141 | Nelson et al. 2013. |
Expected numbers of people who could be contacted with final rule, (e) = (d) x 15% | 21 | Assumption. |
Among those contacted, 70% would have evidence of measles immunity (f) = (e) x 70% | 15 | Nelson et al. 2013 (Table 2). |
Among those contacted, 30% may be susceptible to measles (g) = (e) x 30% | 6 | Nelson et al. 2013 (Table 2). |
47 Nelson, K., Marienau, K.J., Schembri, C. and Redd, S. (2013). “Measles transmission
during air travel, United States.” Travel Medicine and Infectious Disease (2013) 11,
81e89 11: 81-89. |
Table 25—Estimated Marginal Costs for Health Departments To Contact Exposed Travelers
and Offer Measles Post-Exposure Prophylaxis (Vaccination), 2015 USD
Number of additional names sent to health department, (c) | 8.5 |
Additional cost per contact to health department to search for and examine contacts
(USD per contact) (h) | $180 |
Additional cost to health department to search for contacts, total (USD), (i) = (c)
x (h) | $1,530 |
MMR vaccine price per dose (USD) (j) | $39 |
Vaccine administration (k) | $31 |
Estimated cost prophylactic measles vaccine per person (USD), (l) = (j) + (k) | $70 |
Number of individuals who may receive measles vaccine, (g) | 6 |
Cost of measles vaccination, total (USD) (m) = (g) x (l) | $420 |
Total additional annual cost to follow up with more contacts (USD), (i) + (m) | $1,950 |
In addition, HHS/CDC assumes that the final rule could improve health departments’
abilities to contact 15% of those who could not be currently contacted because of
insufficient contact information (21 contacts per year). HHS/CDC does not have any
data to measure the magnitude of improvement and applies a range of 10% to 20% to
calculate lower and upper bounds. If airlines and vessel operators do not have any
additional data besides what is already transmitted to DHS, there will be very little
improvement. Among the 21 additional exposed travelers that would be contacted, 70%
of them (15 per year) are expected to have measles immunity because they were born
before 1957, had history of measles, or received one or more doses of measles vaccine.
The remaining 6 travelers per year without proven measles immunity would incur additional
costs if they are vaccinated (vaccine costs + vaccine administration, Table 25).
To be conservative, HHS/CDC assumes that all 6 exposed travelers would be adults and
would be vaccinated with the measles-mumps-rubella (MMR) vaccine. The vaccine price
for adults is estimated from the Vaccines for Children vaccine price archives (July
2014 and July 2015)
48 based on the public sector price for the vaccine. Vaccine administration costs are
estimated from Healthcare Solutions’ 2015 Physicians’ Fee & Coding Guide (CPT 90471).
49 Total costs resulting from the final rule are summarized in Table 26.
49 InGauge Healthcare Solutions. 2015 Physicians’ Fee & Coding Guide. Atlanta GA2013.
Table 26—Marginal Impact of Final Rule To Improve Contact InvestigationsMarginal cost for measles investigations | Additional names provided to health departments | Addition contacts reached by health departments | Number of travelers provided post-exposure prophylaxis | Number of travelers identified earlier | Average probability that contact is infected |
$1,950 | 8.5 | 21 | 6 | Unknown | 0.0035-0.0095 |
In the absence of interventions by public health departments, travelers infected with
measles during international travel would be as likely as any other individuals to
spark a measles outbreak. In the absence of HHS/CDC efforts to retrieve and transmit
contact data, public health departments would not be able contact travelers to offer
post-exposure prophylaxis and/or to recommend self-monitoring for potential measles
symptoms.
For measles in 2011, 16 outbreaks occurred leading to 107 cases. An outbreak was defined
based on 3 or more cases in a cluster.
50 The remaining 113 cases reported in 2011 resulted in one or two cases per cluster.
Thus, the probability that any individual measles index case leads to an outbreak
was between 16/(16+113) = 12.4% and 16/(16+57) = 20.1%. The lower bound represents
an assumption that all of the 113 cases unassociated with outbreaks of 3 or more cases
occurred in clusters with just one case each. The upper bound represents a scenario
with 56 clusters of two cases each with one cluster with one case. Thus, the probability
that any individual measles case could spark an outbreak of 3 or more cases is 12.4%
to 20.1%. The
[*6952] average cost to public health departments per measles outbreak is $250,000 and the
upper bound cost is $1 million.
51
50 Ortega-Sanchez IR, Vijayaraghavan M, Barskey AE, Wallace GS. The economic burden
of sixteen measles outbreaks on United States public health departments in 2011. Vaccine.
2012;32(11).
51 Ortega-Sanchez IR, Vijayaraghavan M, Barskey AE, Wallace GS. The economic burden
of sixteen measles outbreaks on United States public health departments in 2011. Vaccine.
2012;32(11).
HHS/CDC assumes that the probability that a measles case resulting from exposure during
travel and that is not contacted by a public health department is as likely as any
other measles case to initiate a measles outbreak of 3 or more cases, which occurs
at an approximate probability of 12.4% to 21.9%. The average cost to health departments
is $250,000 for each of these outbreaks and the average outbreak size is about 7 cases
(107 cases/16 outbreaks).
The estimated illness costs for measles are $300 ($86-$515) for outpatient cases and
$24,500 ($3,900-$45,052) for inpatient cases.
52 The probability of hospitalization is estimated to be 44.3%.
53 A range of hospitalization rates is estimated based on 50% to 150% of this base case
estimate (22%-66%). The measles case fatality rate has been estimated to be 0.2%.
54 HHS/CDC assumes that the value of statistical life is $9.4 million (range $4.3 million
to $14.2 million). This value is an estimate of the average willingness to pay to
reduce one’s mortality risk by a small increment not an estimate of the value of any
specific person’s life. For example if 1,000 people were willing to pay $1,000 each
to reduce their risk of death by 1/1,000, the value of statistical life would be equal
to $1,000/0.001 change in risk of death = $1 million. Alternatively 1,000 people each
experiencing a mortality risk reduction of 0.001 would correspond to 1,000 people
x 0.001 mortality risk reduction = 1 statistical life; 1,000 people each willing to
pay $1,000 = 1,000 x $1,000 = $1 million to avert that one statistical death. Using
these estimates, the average illness costs associated with a measles case (Table 27)
is about $30,000 ($9,500 to $58,000).
52 Zhou F, Shefer A, Wenger J, Messonnier M, Wang LY, Lopez A, et al. Economic Evaluation
of the Routine Childhood Immunization Program in the United States, 2009. Pediatrics.
2014;133:577-85.
53 Mason WH, Ross LA, Lanson J, Wright HT. Epidemic measles in the postvaccine era:
evaluation of epidemiology, clinical presentation, and complications during an urban
outbreak. Pediatr Infect Dis J. 1993;12:42-8.
Table 27—Estimated Illness and Mortality Costs per Measles Case | Best estimate | Lower bound | Upper bound |
Outpatient cost, a | $300 | $86 | $515 |
Inpatient cost, b | $24,500 | $3,943 | $45,052 |
Hospitalization rate, c | 44.30% | 22.0% | 66.0% |
Case fatality rate, d | 0.2% | 0.2% | 0.2% |
VSL, e | $9,400,000 | $4,300,000 | $14,200,000 |
Total cost per case (b x c + a x (1-c) + d x e) | $29,821 | $9,535 | $58,309 |
The estimated number of measles cases that will occur in contacts exposed during travel
(3.6 to 10.1) can be multiplied by the probability of an outbreak with 3 or more cases
(12.4% to 21.7%) to estimate the expected number of outbreaks in the absence of public
health intervention to conduct contact investigations in exposed travelers. For each
outbreak, HHS/CDC assumes that an average of 6 additional cases occur with associated
morbidity and mortality costs. The estimated costs of measles outbreaks in the absence
of contact investigations for exposed travelers is presented in Table 28.
Table 28—Estimated Illness, Mortality, Public Health Response Costs Associated with
Measles Outbreaks | Best estimate | Lower bound | Upper bound |
Estimated number of measles cases among contacts, a | 6.85 | 3.6 | 10.1 |
Probability of measles outbreak, b | 17 | 12.4 | 21.9 |
Number of additional cases per outbreak, c | 6 | 6 | 6 |
Estimated number of outbreaks, d = a x b | 1.18 | 0.45 | 2.22 |
Estimated number of outbreak cases, e = a x b x c | 7.06 | 2.68 | 13.29 |
Estimated health department costs per outbreak, f | 250,000 | 250,000 | 250,000 |
Estimated health department costs, g = f x d | 293,989 | 111,607 | 553,758 |
Average cost per case, h | 29,821 | 9,535 | 58,309 |
Estimated illness costs, I = h x e | 210,406 | 25,539 | 774,944 |
Estimated total costs, g + i | 504,395 | 137,146 | 1,328,703 |
HHS/CDC has not received any reports of large measles outbreaks associated with measles
cases in patients exposed during travel and contacted by State or local public health
departments. As a result, HHS/CDC believes that when measles cases occur in contacts
reached by health departments, the probability of an outbreak is significantly mitigated
by pre-warning of exposure before disease outset. Given that HHS/CDC estimates that
health departments are able to reach approximately 75% of contacts under the status
quo, HHS/CDC assumes that the risk of an outbreak has been reduced by at least 60%
under the status quo. Further, HHS/CDC assumes that the provisions in the final rule
further improve health departments’ ability to prevent measles outbreaks in cases
that occur among travelers exposed during flights. A modest improvement of 15% is
assumed (range 10%-20%) resulting in estimated benefits of about $45,000 ($8,000 to
$159,000) in Table 29.
[*6953]
Table 29—Estimated Benefits Associated With Improvement of Measles Contact Investigations
as a Result of This Final Rule | Best estimate | Lower bound | Upper bound |
Estimated total costs without intervention, j = g + i | $504,395 | $137,146 | $1,328,703 |
Estimated effectiveness of outbreak prevention baseline, k | 60% | 60% | 60% |
Estimated cost of measles outbreaks under baseline, j x (1-k) | $201,758 | $54,858 | $531,481 |
Estimated effectiveness of outbreak prevention with final rule, l | 69% | 66% | 72% |
Estimated cost of measles outbreaks with final rule, m = j x (1-l) | $156,363 | $46,630 | $372,037 |
Estimated benefit associated with final rule, n = j-m | $45,396 | $8,229 | $159,444 |
Although measles is not a quarantinable disease and tuberculosis is a quarantinable
disease, HHS/CDC’s and health departments’ approaches to contact investigations are
relatively similar. However, HHS/CDC may issue isolation orders for individuals with
active tuberculosis in some situations, but would not have authority to issue isolation
(or quarantine orders) for individuals with measles. The expected benefits associated
with reduced tuberculosis morbidity and mortality of contact investigations for exposed
travelers are based on a previous analysis, which estimated a return on investment
of $1.01 to $3.20 for the baseline situation in which an estimated 19% of exposed
contacts are found to have latent tuberculosis infection.
55 The contact rate for exposed tuberculosis contacts is probably higher than for measles
because the vast majority of tuberculosis contacts are exposed during international
travel as exposed to measles contacts, which are approximately evenly divided between
interstate and international travel.
55 Coleman M, Marienau K, Marano N, Marks S, Cetron M, Dis TMI. Economics of United
States Tuberculosis Airline Contact Investigation Policies. Travel Medicine and Infectious
Disease. 2014;12:63-71.
The estimated costs to provide testing and treatment to contacts that test positive
for latent tuberculosis infection are estimated to be $1,044 for infected contacts
that complete a full course of treatment and $591 for infected contacts that discontinue
treatment after 30 days.
56 Following the assumptions in the article, an estimated 28% of persons who test positive
for latent tuberculosis infection do not start treatment. An estimated 46% start and
complete treatment and the remaining 26% start, but do not complete treatment. The
authors estimated that the risk of progression to active tuberculosis is reduced by
80% for those that complete treatment. The authors assumed that there is no effect
for individuals that start, but do not complete treatment. HHS/CDC assumes that under
the status quo that health departments are able to contact 75% of exposed travelers
(based on the reported outcomes from measles contact investigations).
57
56 Coleman M, Marienau K, Marano N, Marks S, Cetron M, Dis TMI. Economics of United
States Tuberculosis Airline Contact Investigation Policies. Travel Medicine and Infectious
Disease. 2014;12:63-71.
57 Nelson K, Marienau K, Schembri C, Redd S. Measles transmission during air travel,
United States, December 1, 2008-December 31, 2011. Travel Med Infect Dis. 2013;11(2):81-9.
The costs to provide treatment for latent tuberculosis infections under the status
quo are summarized in Table 30. In total, the costs are almost $900,000 including
about $720,000 to locate contacts and about $180,000 to provide treatment to individuals
with latent tuberculosis infection.
Table 30—Baseline Estimated Costs To Conduct Tuberculosis Contact Investigations and
To Provide Treatment | Number of contacts | Estimated cost per contact | Estimated cost | Notes |
Estimated cost of contact investigations | 1,995 | $360 | $718,092 | Number of contacts from Table 13 and cost per contact from Table 11. |
Estimated number of contacts reached by health departments (75%) | 1,496 | NA | | Estimated at 75% similar to measles from Table 24. |
Estimated number of contacts reached by health departments and have latent TB infection
(19% of 75%) | 284 | NA | | Estimated 19% of contacts have LTBI (Table 13). |
Number of contacts that never start treatment (28%) | 79.6 | 0 | 0 | 28% of 284 contacts with LTBI. |
Number of contacts that complete treatment (46%) | 130.8 | 1,044 | 136,506 | 46% of 284 contacts with LTBI. |
Number of contacts that start, but not compete treatment, (26%) | 73.9 | 591 | 43,677 | 26% of 284 contacts with LTBI. |
Total cost | | | 898,275 | |
The benefits associated with tuberculosis contact investigations are estimated from
a published article, which reported a range of $1.01 to $3.20. This analysis did not
include the potential benefits from reduced onward transmission of tuberculosis among
averted cases, potentially resulting in a conservative estimate of the return on investment.
The formula used to derive estimated benefits from the return on investment (ROI)
is Estimated Benefits = Estimated Costs x ROI + Estimated Costs. The estimated benefits
are $2.6 million and are shown in Table 31 (range: $1.8 million to $3.8 million).
[*6954]
Table 31—Baseline Estimated Costs and Benefits for Tuberculosis Contact Investigations,
2015 USD | Best estimate | Lower bound | Upper bound | Notes |
Estimate costs for contact investigations and treatment | $898,260 | $898,260 | $898,260 | Table 30. |
Return on investment from tuberculosis contact investigations | 1.91 | 1.01 | 3.20 | Coleman et al. |
Estimated benefits | 2,613,936 | 1,805,502 | 3,772,691 | = Cost x ROI + Costs. |
The provisions in the final rule should result in a small increase (assumed baseline
of 10%, range: 5-15%) in the number of contacts reached by health departments and
offered treatment for latent tuberculosis infection. This estimated improvement is
less than that assumed for measles because tuberculosis usually involves a much longer
period of latent infection prior to active disease; thus, tuberculosis contact investigations
are less time sensitive relative to measles contact investigations. The estimated
costs associated with this marginal improvement to reach more contacts can be estimated
by multiplying the costs of providing latent tuberculosis ($180,000) by this range
of improvement (5%-15%) as shown in Table 32. This results in marginal increased costs
associated with the final rule of $18,000 (range: $9,000 to $27,000). The estimated
benefits (Table 32) associated with the final rule are $52,000 (range: $18,000 to
$114,000).
Table 32—Estimated Costs and Benefits for Tuberculosis Contact Investigations Associated
With This Final Rule, 2015 USD | Best estimate | Lower bound | Upper bound | Notes |
Baseline contact investigation costs | $718,080 | $718,080 | $718,080 | |
Baseline latent tuberculosis treatment costs | $180,180 | $180,180 | $180,180 | Table 30 costs for latent tuberculosis treatment and testing. |
Estimated improvement in health departments’ abilities to contact exposed travelers | 10% | 5% | 15% | Assumed. |
Estimated increased cost for latent tuberculosis treatment under final rule | $18,018 | $9,009 | $27,027 | Estimated cost for improvement in contact rate as result of final rule. |
Estimated costs under final rule | $916,278 | $907,269 | $925,287 | Estimated baseline cost + increased cost as result of final rule. |
Estimated ROI | $1.91 | $1.01 | $3.20 | Table 30. |
Estimated benefits for final rule | $2,666,368 | $1,823,610 | $3,886,204 | = Cost x ROI + Costs. |
| | | | |
Estimated costs associated with final rule | $18,018 | $9,009 | $27,027. | Calculated from the difference in costs for the final rule—Baseline costs. |
Estimated benefits associated with final rule | $52,432 | $18,108 | $113,513 | Calculated from the difference in benefits for the final rule—Baseline benefits. |
The total costs for measles and tuberculosis contact investigation activities are
estimated by summing the costs and benefits of measles contact investigations (Table
29) and tuberculosis contact investigations (Table 32). The results are summarized
in Table 33.
Table 33—Changes in Measles and Tuberculosis Contact Investigations Costs and Benefits
Relative to Baseline, 2015 USD | Best estimate | Lower bound | Upper bound |
Final rule benefits | $97,828 | $26,337 | $272,958 |
Final rule costs | 19,968 | 10,959 | 28,977 |
Note: This table includes the sum of results in Tables 29 and 32. |
The total quantified benefits (Table 34) resulting from the improvement of the quality
and timeliness of traveler contact data or the improvement of illness reporting is
summarized by summing the improved efficiency for HHS/CDC to provide contact data
to health departments and improved efficiency for health departments to contact exposed
travelers (Table 23) and the reductions associated with measles and tuberculosis morbidity
and mortality (Table 33).
[*6955]
Table 34—Total Annual Costs and Benefits Associated With Improved Efficiency Public
Health Response Activities, 2015 USD | Best estimate | Lower bound | Upper bound |
Final rule benefits | $110,045 | $26,337 | $297,393 |
Final rule costs | 19,968 | 10,959 | 28,977 |
The benefits and costs associated with improved effectiveness of contact investigations
(Table 34) can be combined with the increased costs to airlines, vessel operators,
DOT/FAA, and HHS/CDC to submit and respond to illness reports or to provide more timely
and complete traveler contact data for manifest requests (Table 19) to estimate the
total annual costs and benefits of the final rule (Table 35).
Table 35—Total Annual Costs and Benefits of the Final Rule, 2015 USD | Best estimate | Lower bound | Upper bound |
Final rule benefits | $110,045 | $26,337 | $297,393 |
Final rule costs | 32,622 | 10,959 | 430,839 |
HHS/CDC does not have sufficient data to quantify the health impact of contact investigations
for pertussis, rubella, varicella (vessels only), viral hemorrhagic fevers (including
Ebola), MERS, or SARS. HHS/CDC attempts to continuously update its contact investigation
protocols based on available evidence. In the past few years, HHS/CDC has stopped
requesting data to conduct mumps contact investigations
58 and has modified its protocol to reduce the number of tuberculosis contacts investigated.
59
58 Nelson KR, Marienau KJ, Barskey AE, Schembri C. No evidence of mumps transmission
during air travel, United States, November 1, 2006-October 31, 2010. Travel Medicine
and Infectious Disease. 2012;10:165-71.
59 Marienau KJ, Cramer EH, Coleman MS, Marano N, Cetron MS. Flight related tuberculosis
contact investigations in the United States: comparative risk and economic analysis
of alternate protocols. Travel Med Infect Dis. 2014;12(1):54-62.
Experience from interstate flight contact investigations suggest that travelers may
want to know when they have been exposed to communicable diseases during flights.
The first Ebola contact investigation conducted in the United States occurred in October,
2014, and found that 60 travelers out of 164 had no contact information on the manifest
that was provided by the airline. A second request was made to the airline after it
was announced to the media that the airline had contacted over 800 travelers, including
travelers who had flown on the same plane subsequent to the flight with the Ebola.
At that time the airline was able to provide HHS/CDC more complete information for
all travelers.
It is likely that the need for CDC to put out media requests for travelers to contact
the Agency created a level of fear in the general population that may not have been
necessary if better contact data were available. In addition, this fear may have led
to non-health costs (such as fear of airplane travel) that would have been mitigated
if the Agency were able to contact all passengers without the media request. However,
when HHS/CDC solicited public comment about perceived willingness to pay to be contacted
in the event of an exposure to a communicable disease during, HHS/CDC only received
a few public comments, all of which indicated that they had zero willingness to pay
in the event of an exposure to a communicable disease.
In summary, improved alignment between regulatory text and HHS/CDC’s publicly available
guidance should reduce compliance costs for airlines and vessel operators while improving
HHS/CDC’s ability to respond to public health threats associated with international
and interstate travel. To the extent that airlines and vessel operators improve responsiveness
to HHS/CDC traveler data requests, HHS/CDC may become better able to respond to infectious
diseases threats and (1) reduce case-loads during infectious disease outbreaks, (2)
reduce public anxiety during disease outbreaks, (3) mitigate economic impacts on businesses
as a consequence of reduced public anxiety, and (4) reduce the amount of personnel
labor time to conduct large-scale CIs in response to a new infectious disease or one
with serious public health and medical consequences like Ebola. HHS/CDC will make
all reasonable efforts to work with DHS/CBP via CDC’s liaison located at the National
Targeting Center, as provided through internal Memorandum of Understanding, to search
and obtain data collected from their APIS and PNR data sets prior to contacting airlines
or vessel operators with duplicate data requests.
For the less restrictive alternative, HHS/CDC assumes that the process of requesting
contact data from airlines and vessel operators would be discontinued. Thus, the cost
to provide such data can be modeled as a benefit to airlines and vessel operators
equal to their costs under the baseline. For the more restrictive alternative, HHS/CDC
assumes that suspension of entry may be implemented for travelers from countries experiencing
widespread transmission of quarantinable communicable diseases. HHS/CDC notes that
suspension of entry would not be considered for non-quarantinable diseases (refer
to Table 4). Specifically, HHS/CDC assumes that persons traveling from affected countries
are not permitted entry to the United States unless such persons spend an amount of
time equivalent to the incubation period for the target disease at a location where
they are not at risk of exposure and are also screened for symptoms of the disease
prior to travel to the United States. During the 2014-2016 Ebola epidemic, travelers
from Liberia, Sierra Leone or Guinea would not be able to enter until 21 days in another
country or within the affected country but separated from others in a manner that
excludes the possibility of interaction with potentially infected individuals.
On average, HHS/CDC has conducted about 2.5 contact investigations for viral hemorrhagic
fevers and MERS coronavirus over the past six years. HHS/CDC assumes that if suspensions
[*6956] of entry may be in place, some fraction of these contact investigations may not be
conducted.
Thus, the cost to airlines and vessel operators to provide traveler contact data would
decrease for the less restrictive alternative resulting in estimated benefits of $75,924.
For the more restrictive scenario, the costs are relatively similar as for the final
rule except for the reduction in cost associated with providing contact data for 2.5
investigations ($12,338 vs. $12,654) and calculating the cost reduction of doing 2.5
fewer contact investigations each year ($1,898) (Table 36).
Table 36—Estimate of the Costs and Benefits to Airlines and Vessel Operators To Provide
Traveler Contact Data, 2015 USD | Baseline | Final rule | Less restrictive alternative a | More restrictive alternative b |
Baseline number of contact investigations | 100 | 100 | 0 | 97.5 |
Costs |
Best estimate | NA | $12,654 | $0 | $12,338 |
Lower bound | NA | 0 | 0 | 0 |
Upper bound | NA | 25,308 | 0 | 24,802 |
Benefits |
Best estimate | NA | $0 | $75,924 | $1,898 |
Lower bound | NA | 0 | 75,924 | 1,898 |
Upper bound | NA | 0 | 75,924 | 1,898 |
a The less restrictive alternative is less expensive than the status quo, because HHS/CDC
does not request data from airlines and attempt to provide data to health departments
to follow up with exposed travelers. |
b The more restrictive alternative also could potentially reduce costs to airlines
and vessel operators because HHS/CDC would restrict travel to countries undergoing
widespread transmission of quarantinable communicable diseases such as viral hemorrhagic
fevers, MERS or SARS. |
HHS/CDC examines two alternatives: A less restrictive alternative in which HHS/CDC
relaxes its regulatory authorities to make illness reporting compliance voluntary
rather than compulsory. Under the more restrictive alternative HHS/CDC may enforce
the current requirement that airlines report all persons with communicable diseases
to local health departments in addition to reporting to HHS/CDC.
The current status quo for illness reporting is summarized in Tables 9 and 10. Reports
can be subdivided by illnesses that fit (1) the ill person definition specified in
current
42 CFR 71.1, (2) reports based on HHS/CDC’s guidance for airlines and vessel operators, or (3)
illness reports unrelated to current regulation or guidance. As shown in Table 9,
only about 53 out of 175.4 (30%) illness reports during air travel appear to be based
on symptoms included in the current definition of an ill person in existing 71.1.
The remaining 70% of reports are based on symptoms currently requested by HHS/CDC,
but not required. In addition, only 67% of illness reports during air travel require
HHS/CDC response and follow-up. In comparison, illness reports from vessels are much
more likely to be based on the definition of ill person as defined in current 71.1
(174.6/218.6 or 80%). In addition, a much greater proportion of reports require an
HHS/CDC follow-up (>95%). This may result from differences in the types of illnesses
observed on vessels relative to aircraft or because of the presence of medical officers
on cruise vessels, who may be better able to identify communicable diseases of public
health concern during travel relative to aircraft personnel.
If illness reporting were entirely voluntary, HHS/CDC assumes the number of reports
(both info-only and reports requiring response) would decrease by 50% from both airlines
and vessel operators (refer to Tables 9 and 10) from the current status quo. HHS/CDC
does not have any data to estimate the magnitude of decrease in reporting. HHS/CDC
believes that both HHS/CDC and DOT/FAA would continue to maintain their current infrastructure
to effectively respond to public health emergencies either on aircraft or vessels.
Thus, relative to the status quo, the primary impact of voluntary reporting would
be reduced incremental time costs for pilots in command and masters of vessels, travelers,
DOT/FAA, and HHS/CDC, especially for info-only illness reports. This 50% reduction
in illness reporting would generate benefits from cost reductions for airlines and
vessel operators, HHS/CDC, travelers, and DOT/FAA of approximately $14,700 (Tables
37 and 38).
The adverse impact for the less restrictive alternative relative to the baseline would
be reduced capacity for HHS/CDC to respond quickly to communicable disease threats
occurring during travel. This is analyzed in a subsequent section on the health impact
of regulated activities.
Table 37—Less Restrictive Alternative for Illness Reporting
[Effect on info-only reports, 2015 USD]Employee type | Change in number of info-only reports | Amount of time required per report (min) | Estimated wage rate (per hr.) | Overhead multiplier (%) | Estimated benefit (cost reduction) |
Aircraft: | | | | | |
Aircraft Pilots or Copilots | 60 | 2 | $57.35 | 100 | $229 |
CDC employee | 60 | 60 | 39.83 | 100 | 4,780 |
DOT/FAA employees | 60 | 26 | 70.57 | 100 | 3,670 |
Traveler | 60 | 10 | 23.23 | 0 | 232 |
Air total | | | | | 8,911 |
Vessels: | | | | | |
Captains, Mates, and Pilots of Water Vessels | 6 | 2 | 39.95 | 100 | 16 |
CDC employee | 6 | 60 | 39.83 | 100 | 478 |
Traveler | 6 | 10 | 23.23 | 0 | 23 |
Maritime total | | | | | 517 |
Total (Air + Maritime) | | | | | 9,428 |
Assume 50% reduction in reports. |
Table 38—Less Restrictive Alternative for Illness Reporting
[Effect on reports requiring response, 2015 USD]Employee type | Change in number of info-only reports | Amount of time required per report (min) | Estimated wage rate (per hr.) | Overhead multiplier (%) | Estimated benefit (cost reduction) |
Aircraft: | | | | | |
Aircraft pilots or copilots | 29 | 2 | $57.35 | 100 | $111 |
CDC employee | 29 | 0 | 39.83 | 100 | |
DOT/FAA employee | 29 | 26 | 70.57 | 100 | 1,774 |
Traveler | 29 | 60 | 23.23 | 0 | 674 |
Total | | | | | 2,558 |
Vessels: | | | | | |
Captains, mates, and pilots (masters) of vessels | 104 | 2 | 39.95 | 100 | 277 |
CDC employee | 104 | 0 | 39.83 | 100 | |
Traveler | 104 | 60 | 23.23 | 0 | 2,416 |
Total | | | | | 2,693 |
Total (Air + Maritime) | | | | | 5,251 |
Notes: Assume 50% reduction in air illness reports and 15% of maritime illness reports (response,
international and interstate). |
Under the more restrictive alternative, HHS/CDC would require duplicate illness reporting
both to HHS/CDC and to local health departments with jurisdiction upon arrival for
interstate flights and voyages. This alternative is based upon the existing regulatory
text under
42 CFR 70.4. HHS/CDC assumes that 50% of illness reports occur during interstate (relative to
international) air travel and that 15% of maritime illness reports occur during interstate
travel. The time required for pilots in command and masters of vessels is assumed
to be about 4 minutes. This duration is greater than the amount of time estimate for
reporting to HHS/CDC because pilots in command and masters of vessels may have to
search for contact information for local health departments and because local health
departments may have less experience dealing with illness reports than HHS/CDC. The
costs to airlines and vessel operators is estimated to be $848 per year (Table 39).
Since HHS/CDC would coordinate responses to illness reports with local health departments
under the status quo, there are no additional costs or benefits to requiring duplicative
reports to local health departments. These costs would be added to the costs of the
changes resulting from the final rule.
Table 39—More Restrictive Alternative (Illness Reporting in Duplicate to HHS/CDC and
to Local Health Departments), 2015 USDEmployee type | Change in number of info-only reports | Amount of time required per report (min) | Estimated wage rate (2015 USD per hr.) | Overhead multiplier (%) | Estimated cost ($2015 USD) |
Aircraft pilots or copilots | 88 | 4 | $57.35 | 100 | $673 |
Captains, mates, and pilots (masters) of vessels | 33 | 4 | 39.83 | 100 | 175 |
Total | | | | | 848 |
The total costs and benefits associated with the more and less restrictive illness
reporting scenarios as compared to the final rule are summarized in Table 40.
Table 40—Best Estimate, Lower Bound and Upper Bound of the Changes in Annual Monetized
Benefits and Costs as a Result of the Change to the Reportable Illness Definition,
2015 USD | Best estimate | Lower bound | Upper bound |
Costs |
Final Rule: | | | |
Aircraft | $0 | $0 | $375,751 |
Vessels | 0 | 0 | 802 |
Total | 0 | 0 | 376,554 |
Less Restrictive Alternative: a | | | |
Aircraft | 0 | 0 | 0 |
Vessels | 0 | 0 | 0 |
Total | 0 | 0 | 0 |
More Restrictive Alternative: | | | |
Aircraft | 673 | 673 | 376,424 |
Vessels | 175 | 175 | 978 |
Total | 848 | 848 | 377,402 |
Benefits |
Final Rule: | | | |
Aircraft | 0 | 0 | 0 |
Vessels | 0 | 0 | 0 |
Total | 0 | 0 | 0 |
Less Restrictive Alternative: a | | | |
Aircraft | 11,469 | 11,469 | 11,469 |
Vessels | 3,210 | 3,210 | 3,210 |
Total | 14,679 | 14,679 | 14,679 |
More Restrictive Alternative: | | | |
Aircraft | 0 | 0 | 0 |
Vessels | 0 | 0 | 0 |
Total | 0 | 0 | 0 |
a For the less restrictive scenario, the current reporting requirement is relaxed leading
to a reduction in costs. |
The total costs of the alternatives compared to the final rule are summarized in Table
41 and include the costs of the change to the definition of an “ill person” and the
codification of the requirement for airlines to provide passenger contact data for
the final rule, the less restrictive alternative, and the more restrictive alternative.
Table 41—Total Costs and Benefits Resulting From Codification of Traveler Data Collection
(71.4 and 71.5) and Change to Definition of “Ill Person” (70.1 and 71.1) | Best estimate | Lower bound | Upper bound |
Costs |
Final Rule: | | | |
71.4 and 71.5 Passenger data collection | $12,654 | $0 | $25,308 |
70.1 and 71.1 Change in definition of an “ill person” | 0 | 0 | 376,554 |
Total costs | 12,654 | 0 | 401,862 |
Less Restrictive Alternative: | | | |
71.4 and 71.5 Passenger data collection | 0 | 0 | 0 |
70.1 and 71.1 Change in definition of an “ill person” | 0 | 0 | 0 |
Total costs | 0 | 0 | 0 |
More Restrictive Alternative: | | | |
71.4 and 71.5 Passenger data collection | 12,338 | 0 | 24,802 |
70.1 and 71.1 Change in definition of an “ill person” | 848 | 848 | 377,402 |
Total costs | 13,186 | 848 | 402,204 |
Benefits |
Final Rule: | | | |
71.4 and 71.5 Passenger data collection | 0 | 0 | 0 |
70.1 and 71.1 Change in definition of an “ill person” | 0 | 0 | 0 |
Total benefits | 0 | 0 | 0 |
Less Restrictive Alternative: | | | |
71.4 and 71.5 Passenger data collection | 75,924 | 75,924 | 75,924 |
70.1 and 71.1 Change in definition of an “ill person” | 14,679 | 14,679 | 14,679 |
Total benefits | 90,603 | 90,603 | 90,603 |
More Restrictive Alternative: | | | |
71.4 and 71.5 Passenger data collection | 1,898 | 1,898 | 1,898 |
70.1 and 71.1 Change in definition of an “ill person” | 0 | 0 | 0 |
Total benefits | 1,898 | 1,898 | 1,898 |
For the less restrictive alternative, the change relative to baseline is equal to
the current cost of performing Cis for travelers exposed on international flights
($745,000 each for HHS/CDC and local health departments or a total of about $1.5 million,
Table 20). Under the more restrictive alternative (i.e. implementing travel restrictions immediately upon evidence of widespread transmission
of viral hemorrhagic fevers, SARS or MERS, the costs of these contact investigations
are assumed to be avoided (potential cost reductions of about $29,000 each to HHS/CDC
and health departments or $58,000 in total). The benefits of the avoided contacted
investigations are then added to the cost savings for the remaining contacts assuming
a 0-3% improvement in HHS/CDC efficiency and a 0-2% improvement in PHD efficiency
as for the final rule (Table 42).
Table 42—Estimated Benefits Associated With Reduced Costs To Conduct Contact Investigations | HHS/CDC benefits | PHD benefits | Total |
Final Rule: | | | |
Best estimate | $7,331 | $4,887 | $12,218 |
Lower bound | 0 | 0 | 0 |
Upper bound | 14,661 | 9,774 | 24,435 |
Less Restrictive Alternative: | | | |
Best estimate | 745,380 | 745,380 | 1,490,760 |
Lower bound | 745,380 | 745,380 | 1,490,760 |
Upper bound | 745,380 | 745,380 | 1,490,760 |
More Restrictive Alternative: | | | |
Best estimate | 36,671 | 34,227 | 70,898 |
Lower bound | 29,340 | 29,340 | 58,680 |
Upper bound | 44,001 | 39,114 | 83,115 |
For this analysis, under the less restrictive alternative, HHS/CDC assumes that no
contact investigations are performed for measles. As a result, the probability of
onward transmission from 3.6 to 10.1 measles patients exposed each year during travel
greatly increases and is modeled based on the estimated costs of measles in the absence
of intervention $504,000 (range: $137,000 to $1.3 million) (Table 28). Measles outcomes
for the more restrictive alternative are the same as estimated for the final rule
since there is no difference in measles efforts between the final rule and the more
[*6960] restrictive alternative because measles is not a quarantinable disease. The comparative
benefits relative to the status quo baseline are shown in Table 43. For the less restrictive
alternative, costs are estimated based on an increase in measles outbreak costs relative
to the baseline.
Table 43—Estimated Benefits Associated With Averted Costs From Measles Outbreaks Relative
to Baseline, 2015 USD | Best estimate | Lower bound | Upper bound |
Benefits |
Final Rule | $45,396 | $8,229 | $159,444 |
Less Restrictive Alternative | 0 | 0 | 0 |
More Restrictive Alternative | 45,396 | 8,229 | 159,444 |
Costs |
Final Rule | 1,950 | 1,950 | 1,950 |
Less Restrictive Alternative a | 201,758 | 54,858 | 531,481 |
More Restrictive Alternative | 1,950 | 1,950 | 1,950 |
a For the less restrictive alternative, contact investigations are not performed so
the cost can be estimated based on the estimated public health benefit of contact
investigations performed under the baseline (Table 29). |
Under the less restrictive alternative, tuberculosis contact investigation are no
longer conducted for persons exposed during travel. Relative to the baseline, there
are neither costs to conduct such investigations (resulting in benefits of about $180,000
to forego providing treatment for latent tuberculosis treatment) or benefits associated
with reduced tuberculosis morbidity and mortality. Relative to the baseline, the estimated
cost of increased tuberculosis morbidity and mortality is estimated to be $2.6 million
(range: $1.8 million to $3.8 million). Under the more restrictive alternative in which
suspension of entry is enforced in response to quarantinable communicable disease
outbreaks, there is no change relative to the final rule results because it is unlikely
that a tuberculosis outbreak would cause suspension of entry. Results are summarized
in Table 44.
Table 44—Changes in Tuberculosis Contact Investigations Costs and Benefits Relative
to Baseline, 2015 USD | Best estimate | Lower bound | Upper bound | Notes |
Benefits |
Final Rule | $52,432 | 18,108 | 113,513 | Table 32. |
Less Restrictive Alternative | 180,180 | 180,180 | 180,180 | Assumed to be the cost to provide LTBI treatment under the baseline (Table 32). |
More Restrictive Alternative | 52,432 | 18,108 | 113,513 | The more restrictive alternative has the same effect on TB contact investigations
as the final rule. |
Costs |
Final Rule | 18,018 | 9,009 | 27,027 | Table 32. |
Less Restrictive Alternative | $2,613,936 | $1,805,502 | $3,772,691 | Estimated based on the benefits of avoided TB morbidity and mortality resulting from
contact investigations under the baseline. |
More Restrictive Alternative | 18,018 | 9,009 | 27,027 | The more restrictive alternative has the same effect on TB contact investigations
as final rule. |
The total costs and benefits of changes in health outcomes associated with the more
and less restrictive alternatives compared to the provisions included in the Final
Rule are summarized in Table 45. The less restrictive alternative in which contact
investigations are no longer pursued shows a large increase in costs relative to the
baseline and in comparison to the provisions in the final rule. In addition, there
are some benefits, but not enough to offset the costs. The more restrictive alternative
does not change health outcomes for tuberculosis and measles in comparison to the
final rule.
[*6961]
Table 45—Changes in Measles and Tuberculosis Contact Investigations Costs and Benefits
Relative to Baseline, 2015 USD | Best estimate | Lower bound | Upper bound |
Benefits |
Final Rule | $97,828 | $26,337 | $272,958 |
Less Restrictive Alternative | 180,180 | 180,180 | 180,180. |
More Restrictive Alternative | 97,828 | 26,337 | 272,958 |
Costs |
Final Rule | 19,968 | 10,959 | 28,977 |
Less Restrictive Alternative | 2,815,694 | 1,860,360 | 4,304,172 |
More Restrictive Alternative | 19,968 | 10,959 | 28,977 |
Note: This table includes the sum of results in Tables 43 and 44. |
The total quantified costs and benefits (Table 46) resulting from the additional data
provision and timeliness of traveler contact data or the improvement of illness reporting
for alternatives to the provisions included in the final rule is summarized by summing
the improved efficiency for HHS/CDC to provide contact data to health departments
and improved efficiency for health departments to contact exposed travelers (Table
42) and the reductions associated with measles and tuberculosis morbidity and mortality
(Table 45).
Table 46—Total Annual Costs and Benefits Associated With Improved Efficiency Public
Health Response Activities, 2015 USD | Best estimate | Lower bound | Upper bound |
Benefits |
FR | $110,045 | $26,337 | $297,393 |
Less Restrictive Alternative | 1,670,940 | 1,670,940 | 1,670,940 |
More Restrictive Alternative | 168,725 | 85,017 | 356,073 |
Costs |
FR | 19,968 | 10,959 | 28,977 |
Less Restrictive Alternative | 2,815,694 | 1,860,360 | 4,304,172 |
More Restrictive Alternative | 19,968 | 10,959 | 28,977 |
The total annual costs and benefits for the alternatives compared to the final rule
are summarized in Table 47. Although the benefits for the more restrictive alternative
in which suspensions of entry would be implemented for countries experiencing outbreaks
of quarantinable communicable diseases are greater than the quantified annual benefits
of the final rule, the costs are underestimated. HHS/CDC does not have sufficient
data to quantify the long term costs of implementing suspensions of entry for countries
experiencing outbreaks of quarantinable diseases; however, such costs would probably
exceed the $100,000 in estimated benefits associated with suspensions of entry that
may result in fewer contact investigations for quarantinable diseases such as Ebola
and MERS. Refer to the appendix for some details of potential costs associated with
hypothetical suspensions of entry for the countries with widespread Ebola transmission
during the 2014-2016 global Ebola epidemic.
Table 47—Total Annual Costs and Benefits of the Final Rule, Less Restrictive and More
Restrictive Alternatives, 2015 USD | Best estimate | Lower bound | Upper bound |
Benefits |
Final Rule | $110,045 | $26,337 | $297,393 |
Less Restrictive Alternative | 1,780,524 | 1,780,524 | 1,780,524 |
More Restrictive Alternative | 170,623 | 86,915 | 357,971 |
Costs |
Final Rule | 32,622 | 10,959 | 430,839 |
Less Restrictive Alternative | 2,815,694 | 1,860,360 | 4,304,172 |
More Restrictive Alternative | 33,154 | 11,807 | 431,181 |
[*6962]
HHS/CDC does not expect that most of the provisions included in the final rule will
result in measurable changes relative to the economic baseline. The primary purpose
of the provisions summarized in list below is to explain how HHS/CDC interprets its
current statutory and regulatory authority under the
Public Health Service Act (
42 U.S.C. 264,
265) and regulations at
42 CFR parts 70 and
71. HHS/CDC is grouping the complementary provisions in part 70 and part 71 in the list
below, when they align, to facilitate public review of the current provisions as well
as those included in the final rule. These changes are intended to clarify the agency’s
standard operating procedures and policies, and due process rights for individuals.
HHS/CDC believes that such clarity is an important qualitative benefit of the provisions
in this final rule, but is not able to monetize this impact in a significant way.
• New Provisions: § 70.5 Requirements relating to travelers under a Federal order
of isolation, quarantine, or conditional release.
○ Baseline and Current Regulatory Provision: § 70.5 Certain communicable disease;
special requirements.
• Without the final rule, HHS/CDC may issue Federal orders to restrict travel for
persons infected or exposed to quarantinable communicable diseases. However, this
process is less transparent and efficient than allowing travel (
i.e. issue travel permits to allow interstate travel to persons under Federal orders for
diseases not currently identified under existing
42 CFR 70.5.) Under current practice, HHS/CDC issues approximately one Federal order per year,
most frequently for tuberculosis, which is a disease not included in the current 70.5.
○ Change relative to baseline as result of final rule
• With the final rule, HHS/CDC is aligning the list of diseases for which individuals
under Federal orders may be allowed to travel with the quarantinable communicable
diseases specified in Executive Order. A potential future qualitative benefit would
be to reduce uncertainty by the individual subject to the order, carrier operators,
and cooperating health and law enforcement entities about whether HHS/CDC could issue
a travel permit to an individual under a Federal order and quantifiable benefit would
be the avoided cost of potential legal challenge.
○ Qualitative benefit/cost of final rule
• Improved transparency for HHS/CDC’s ability to allow individuals under Federal orders
to issue travel permits to allow individuals to travel (interstate). HHS/CDC may allow
persons under Federal orders to travel interstate for whom there is greater uncertainty
regarding HHS/CDC restricting their travel.
○ Monetized benefit/cost of final rule
• Increased clarity around due process may result in fewer resources and time expended
by individuals under orders and HHS/CDC in disagreements over HHS/CDC’s authority
to issue Federal public health orders that limit an individual’s movement. This includes
the potential costs of litigation and associated activities.
• New provisions: § 70.6 Apprehension and detention of persons with specific diseases;
§ 71.32 Persons, carriers, and things (no change to title)
○ Baseline and Current Regulatory Provision:
• Under current
42 CFR 70.6 and §
71.32, HHS/CDC has regulatory authority to apprehend and detain individuals with quarantinable
communicable diseases.
○ Change relative to baseline as result of final rule
• As a result of these new provisions, the major change would be improved transparency
of HHS/CDC’s regulatory authority with regard to the issuance of Federal quarantine,
isolation, or conditional release orders of individuals traveling interstate.
○ Qualitative benefit/cost of final rule
• ;Improved transparency and compliance with Federal orders.
○ Monetized benefit/cost of final rule
• Increased clarity around due process may result in fewer resources and time expended
by individuals under orders, cooperating entities, and CDC in disagreements over HHS/CDC’s
authority to issue Federal public health orders that limit an individual’s movement.
This includes the potential costs of litigation and associated activities.
• New Provisions: § 70.10 Public health prevention measures to detect communicable
disease; § 71.20 Public health prevention measures to detect communicable disease.
○ Baseline and Current Regulatory Provisions: No explicit regulatory provision.
• In the absence of the final rule and under existing statutory authority provided
in the
Public Health Service Act and regulatory authority provided by
42 CFR 70.2 and
71.32(b), HHS/CDC could still implement public health measures at locations where individuals
may gather for interstate travel or at U.S. ports of entry. However, without more
transparent regulatory authority to require such measures, travelers may be less likely
to comply, either by refusing to answer risk assessment questions or providing false
information. This lack of compliance may require that HHS/CDC, if it reasonably believes
that the individual is infected with or has been exposed to a quarantinable communicable
disease, to quarantine, isolate, or place the individual under surveillance under
42 CFR 70.6 or 71.32 and 71.33. HHS/CDC has not implemented public health measures at locations
where individuals may congregate for the purposes of interstate travel in at least
50 years and cannot predict if or how often it may implement measures in the future.
○ Change relative to baseline as result of final rule
• Improved transparency and potentially improved compliance in the event that HHS/CDC
implements such measures in the future.
○ Qualitative benefit/cost of final rule
• Improved transparency and public understanding of HHS/CDC’s rationale and authority
to conduct such measures and require individuals to comply.
○ Monetized benefit/cost of final rule
• Increased clarity around due process procedures may result in fewer resources and
time expended by individuals under orders and HHS/CDC in disagreements over HHS/CDC’s
authority to issue Federal public health orders that limit an individual’s movement.
This includes the potential costs of litigation and associated activities.
• New Provisions: § 70.12 Medical examinations; § 71.36 Medical Examinations
○ Baseline and Current Regulatory Provisions: 71.33 Persons: Isolation and Surveillance.
• This is carried out under statutory authority and under the regulatory authorities
in
42 CFR 70.6 and
71.32(a),
71.33, which would allow for medical examinations of individuals under Federal orders.
○ Change to baseline as result of final rule
• With the final rule, the major change would be an alignment between the statutory
language in the
Public Health Service Act and improved transparency of HHS/CDC’s regulatory authority.
○ Qualitative benefit/cost of final rule
• Improved transparency and public understanding of HHS/CDC’s rationale and authority
to conduct such measures and require individuals to comply.
○ Monetized benefit/cost of final rule
• Increased clarity around due process procedures may result in fewer [*6963] resources and time expended by individuals under orders, cooperating entities, and
HHS/CDC in disagreements over HHS/CDC’s authority to issue Federal public health orders
that limit an individual’s movement. This includes the potential costs of litigation
and associated activities.
• New Provisions: § 70.13 Payment for Care and Treatment; § 71.30 Payment for Care
and Treatment
○ Baseline and Current Regulatory Provisions: No current explicit regulatory provision.
• This addition is not expected to lead to a change in HHS/CDC policy under which
HHS/CDC may act as the payer of last resort for individuals subject to medical examination,
quarantine, isolation, and conditional release under Federal orders. The provisions
included in the final rule are similar to a Memorandum of Agreement between a number
of hospitals and HHS/CDC. Under the terms of the Memorandum of Agreement, the hospital
can be reimbursed for incurred medical expenses subject to HHS/CDC’s discretion, availability
of appropriations, and limited to what a hospital would bill Medicare. The Memorandum
of Agreement also indicates that HHS/CDC should be the payer of last resort.
• HHS/CDC issued 12 isolation orders between Jan 1, 2005 and May 10, 2016, which would
correspond to an average of about 1 order per year over the past 11.3 years. HHS/CDC
has information on payments made for 3 of the 12 cases. In most cases, HHS/CDC makes
payment directly to healthcare facilities, sometimes in lieu of payments that would
be made by State or local health departments. Among the three instances for which
HHS/CDC has some data on payments for treatment, care, and transportation of individuals
under Federal orders:
• HHS/CDC’s expected annual payments for care and treatment are estimated to be between
$0 and $1,000,000 in any given year under the current baseline. This upper bound cost
would correspond to a year in which HHS/CDC would have to incur the costs of two patients
at $500,000 per patient. This roughly corresponds to the average cost to treat an
extremely drug-resistant tuberculosis case (XDR-TB). Alternatively, this could represent
a situation in which HHS/CDC may have to pay a significant fraction of the total costs
for one very complicated illness associated with a quarantinable communicable disease
not endemic to the United States (e.g., Ebola).
• HHS/CDC has not incurred any costs for the care and treatment of any individuals
besides for those under Federal isolation orders.
○ Change to baseline as result of final rule
• Improved transparency around HHS/CDC’s authority for, and requirements and processes
related to payment for care and treatment.
○ Qualitative benefit/cost of final rule
• Improved transparency and public knowledge of HHS/CDC’s procedures and regulatory
requirements.
○ Monetized benefit/cost of final rule
• None. This is a clarification of HHS/CDC’s current practice. (For more details,
please refer to separate RIA Appendix)
• New Provisions: § 70.14 Requirements relating to the issuance of a Federal order
for quarantine, isolation, or conditional release; § 71.37 Requirements relating to
the issuance of a Federal order for quarantine, isolation, or conditional release
○ Baseline and Current Regulatory Provisions: No current explicit regulatory provision
• Without the final rule, HHS/CDC can under current statutory provided by the
Public Health Service Act and regulatory authority under
42 CFR 70.6 and
71.32(a),
71.33 continue to issue Federal quarantine, isolation, or condition release orders. However,
the issuance of federal orders is implemented through internal policies and standard
operating procedures that are not as transparent to the public as detailed regulations
outlining requirements.
○ Change to baseline as result of final rule
• Improved transparency around HHS/CDC’s authority for, and requirements and processes
related to, the issuance of Federal quarantine, isolation, and conditional release
orders.
○ Qualitative benefit/cost of final rule
• Improved transparency and public knowledge of HHS/CDC’s procedures and regulatory
requirements.
○ Monetized benefit/cost of final rule
• None. This is a clarification of HHS/CDC’s current practice.
• New Provisions: § 70.15 Mandatory reassessment of a Federal order for quarantine,
isolation, or conditional release; § 71.38 Mandatory reassessment of a Federal order
for quarantine, isolation, or conditional release
○ Baseline and Current Regulatory Provisions: No current explicit regulatory provision.
• Without the final rule, HHS/CDC can under current statutory authority provided by
the
Public Health Service Act and regulatory authority under
42 CFR 70.6 and
71.32(a),
71.33 continue to issue Federal quarantine, isolation, or conditional release orders. However,
the process for reassessing a Federal order is implemented through internal policy
and standard operating procedures that are not as transparent to the public as detailed
regulations outlining requirements.
○ Change to baseline as result of final rule:
• With the final rule, individuals under Federal order may be more aware of the mandatory
reassessment of a Federal quarantine, isolation, or conditional release order.
○ Qualitative benefit/cost of final rule
• Improved transparency and understanding of due process protections under a Federal
public health order.
○ Monetized benefit/cost of final rule
• Increased clarity around due process protections may result in fewer resources and
time expended by individuals under orders and HHS/CDC in disagreements over HHS/CDC’s
authority to issue Federal public health orders that limit an individual’s movement.
This includes the potential costs of litigation and associated activities.
• New Provisions: § 70.16 Medical review of a Federal order for quarantine, isolation,
or conditional release; § 71.39 Medical review of a Federal order for quarantine,
isolation, or conditional release
○ Baseline and Current Regulatory Provisions: No current explicit regulatory provision.
• Without the final rule, HHS/CDC can under current statutory authority provided by
the
Public Health Service Act and regulatory authority under
42 CFR 70.6 and
71.32,
71.33 continue to issue Federal quarantine, isolation, or conditional release orders. However,
the process for a medical review of a Federal order is outlined in internal policy
and standard operating procedures that are not as transparent to the public as detailed
regulations outlining requirements.
○ Change to baseline as result of final rule:
• With the final rule, individuals under Federal order may become aware of their right
to a medical review, and exercise that right, under this due process provision.
○ Qualitative benefit/cost of final rule
• Improved transparency and understanding of due process afforded to individuals under
a Federal order
○ Monetized benefit/cost of final rule
• Increased clarity around due process protections may result in fewer resources and
time expended by individuals under orders and HHS/CDC [*6964] in disagreements over HHS/CDC’s authority to issue Federal public health orders that
limit an individual’s movement. This includes the potential costs of litigation and
associated activities.
• One potential change that could have an economic effect is the requirements to appoint
medical and legal representatives for individuals that qualify as “indigent”. The
status of “indigent” is self-reported as HHS/CDC will not require access to an individual’s
financial records. Those who self-identify as indigent may be required to sign an
affidavit or declaration under penalty of perjury stating they meet the threshold
of at least 200% of the applicable poverty guidelines. HHS/CDC notes that in practice
it has never denied a request for a representative. HHS/CDC estimates the cost of
providing one medical representative and one legal representative based on the average
hourly wage for physicians and surgeons ($97.33, occupation code 29-1060) and lawyers
($65.51, occupation code 23-1011) as reported from the Bureau of Labor Statistics’
May 2015 National Occupational Employment and Wage Estimates. Assuming that it takes
about 40 hours of physician time and 40 hours of lawyer time per review and an overhead
cost multiplier of 100%, the expected cost is about $13,000 per review. HHS/CDC notes
that public health orders are issued on average once per year. The need for HHS/CDC
to pay for medical and legal representatives will depend on the income level for persons
placed under federal orders, but should not exceed this $13,000 estimate in most years
and will be $0 in many years. Without the new regulatory provision, as part of current
practice, HHS/CDC would still attempt to appoint legal and medical representatives
if requested for the medical review by individuals unable to afford the cost of such
representation. Thus, relative to current practice, there should be minimal costs
associated with this provision.
• New Provisions: § 70.17 Administrative records relating to Federal quarantine, isolation,
or conditional release; § 71.29 Administrative records relating to Federal quarantine,
isolation, or conditional release
○ Baseline and Current Regulatory Provisions: No current explicit regulatory provision.
• Without the final rule, HHS/CDC can issue under current statutory provided by the
Public Health Service Act and regulatory authority under
42 CFR 70.6 and
71.32(a),
71.33 continue to issue Federal quarantine, isolation, or conditional release orders. However,
the process for documenting the administrative record is implemented internal policy
and standard operating procedures that are not as transparent to the public as a detailed
regulation outlining this requirement.
○ Change to baseline as result of final rule
• The requirement, with which HHS/CDC is already complying, will clarify for the public
that certain documents must be retained for the administrative record.
○ Qualitative benefit/cost of final rule
• Improved transparency
○ Monetized benefit/cost of final rule
• Not applicable. This is a codification of an administrative activity within HHS/CDC.
• New Provisions: § 70.18 Penalties/ § 71.2 Penalties
○ Baseline and Current Regulatory Provision: § 71.2 Penalties. Part 70 currently has
no penalties provision.
• Without the final rule, individuals may not be aware that
18 U.S.C. 3559 and
3571 increased the maximum penalties for violations of regulations under
42 CFR part 70 and part 71. And it may not be clear to individuals that violating quarantine regulation
under
42 CFR part 70 may result in criminal penalties.
○ Change to baseline as result of final rule
• With the NRPM, there will be less confusion about the maximum criminal penalties
for a violation of regulations under
42 CFR 70 and
71.
○ Qualitative benefit/cost of final rule
○ Monetized benefit/cost of final rule
• No individual or organization has been assessed criminal penalties for violating
these regulations, so monetizing this benefit or cost is not feasible. This is simply
an effort to align the domestic and foreign quarantine penalties provisions, and updates
outdated regulatory language so that it reflects current statutory language concerning
criminal penalties.
• New Provisions: § 71.63 Suspension of entry of animals, articles, or things from
designated foreign countries and places into the United States
○ Baseline and Current Regulatory Provision: § 71.32(b) has previously been used to
justify the temporary embargo of imported African rodents prior to the codification
of this as a requirement in existing
42 CFR 71.56.
• Without the final rule, individuals may not be aware that HHS/CDC’s authority to
temporarily suspend entry of animals, articles or things from designated foreign countries
and places into the United States based on existing
42 CFR 71.32(b).
○ Change to baseline as result of final rule
• With the NRPM, there will be less confusion about HHS/CDC’s ability to temporarily
restrict importations associated with communicable disease risks.
○ Qualitative benefit/cost of final rule
• Improved transparency.
○ Monetized benefit/cost of final rule
• Refer to the appendix for an analysis of the temporary embargo of African rodents
implemented in 2003.
Under the
Regulatory Flexibility Act, as amended by the
Small Business Regulatory Enforcement Fairness Act (SBREFA), agencies are required to analyze regulatory options to minimize significant
economic impact of a rule on small businesses, small governmental units, and small
not-for-profit organizations. We have analyzed the costs and benefits of the final
rule, as required by Executive Order 12866, and a preliminary regulatory flexibility
analysis that examines the potential economic effects of this rule on small entities,
as required by the
Regulatory Flexibility Act. Based on the cost benefit analysis, we expect the rule to have little or no economic
impact on small entities.
HHS/CDC has determined that this final rule contains proposed information collections
that are subject to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (
44 U.S.C. 3501-3520). A description of these proposed provisions is given below with an estimate of the
annual reporting and recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and maintaining
the data needed, and completing and reviewing each collection of information. Comments
are invited on the following subjects.
• Whether the proposed collection of information is necessary for the proper performance
of the functions of HHS/CDC, including whether the information will have practical
utility.
• The accuracy of HHS/CDC’s estimate of the burden of the collection of information.
• Ways to enhance the quality, utility, and clarity of the information to be collected.
[*6965]
• Ways to minimize the burden of the collection of information on respondents, including
by using information technology.
While HHS/CDC currently has approval to collect certain information concerning illnesses
and travelers under OMB Control Numbers 0920-0134 (Foreign Quarantine Regulations, expiration date 05/31/2019) and 0920-0488 (Restrictions on Interstate Travel of Persons, expiration date 05/31/2019), CDC is requesting updates to certain information collections
within these control numbers.
In another information collection request associated with this final rule, CDC is
also requesting approval to require that airlines and vessels provide certain data
elements to CDC, as described in proposed 71.4 and 71.5, for the purposes of contact
tracing. This information is used to locate individuals, both passengers and crewmembers,
who may have been exposed to a communicable disease during travel and to provide them
with appropriate public health follow-up.
Written comments should be received within 30 days of the publication of this final
rule. Please send written comments to CDC Desk Officer, Office of Management and Budget,
Washington, DC 20503 or by fax to (202) 395-5806.
(1) Foreign Quarantine Regulations (
42 CFR part 71) (OMB Control No. 0920-0134)—Nonmaterial/non-substantive change—National Center for
Emerging, and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).
(2) Restrictions on Interstate Travel of Persons (
42 CFR part 70) (OMB Control No. 0920-0488)—Nonmaterial/non-substantive change—National Center for
Emerging, and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC)
(3) Airline and Vessel and Traveler Information Collection (
42 CFR and 71)—New Information Collection Request—National Center for Emerging, and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Section 361 of the
Public Health Service (PHS) Act (
42 U.S.C. 264) authorizes the Secretary of Health and Human Services to make and enforce regulations
necessary to prevent the introduction, transmission, or spread of communicable diseases
from foreign countries into the United States and interstate. Legislation and existing
regulations governing foreign and interstate quarantine activities (
42 CFR parts 70 and
71) authorize quarantine officers and other personnel to inspect and undertake necessary
control measures in order to protect the public health. Currently, with the exception
of the CDC’s Vessel Sanitation Program, inspections are performed only on those vessels
and aircraft that report illness before arriving or when illness is discovered upon
arrival. Other inspection agencies assist quarantine officers in public health risk
assessment and management of persons, pets, and other importations of public health
importance. These practices and procedures ensure protection against the introduction
and spread of communicable diseases into the United States with a minimum of recordkeeping
and reporting as well as a minimum of interference with trade and travel. The information
collection burden is associated with these recordkeeping and reporting requirements.
At present, HHS/CDC has approval from OMB to collect certain information and impose
recordkeeping requirements related to foreign quarantine responsibilities under OMB
Control Number 0920-0134 (expiration 05/31/2019). The specific provisions within
42 CFR part 71 that include information collection under are as follows:
42 CFR 71.35 Report of death or illness on carrier during stay in port.
42. CFR 71.56 African Rodents
HHS/CDC has also used its authority under
42 CFR 71.32 to require importers to submit statements or documentation of non-infectiousness
for those items that may constitute a public health risk if not rendered non-infectious.
Finally, HHS/CDC has approval from OMB to collect from importers/filers certain documents
and data elements to identify and clear HHS/CDC regulated imports via the Automated
Commercial Environment and the International Trade Data System using the Document
Imaging System and Partner Government Agency Message Sets. These CDC Partner Government
Agency Message Sets are currently limited to: CDC PGA Message Set for Importing Cats
and Dogs, CDC PGA Message Set for Importing African Rodents, CDC PGA Message Set for
Importing African Rodent and All Family Viverridae Products.
In this final rule, CDC is requesting approval from OMB for 4 non-substantive changes
to OMB Control Number 0920-0134 Foreign Quarantine Regulations (
42 CFR part 71):
(1) Updating the definition of “ill person,” which relates to the illness reporting
requirements under
42 CFR 71.21(a), (b), and (c) for airlines and vessels arriving into the United States. CDC is updating
the definition of “ill person” by implementing current practice with the anticipated
effect of better facilitating identification of communicable diseases of concern and
quarantinable communicable diseases aboard flights and maritime voyages to the United
States, diseases such as measles, viral hemorrhagic fevers, active tuberculosis, and
influenza caused by novel or re-emergent influenza viruses that are causing or have
the potential to cause a pandemic. CDC is also including a provision to allow the
Director to add new symptoms to the definition of ill person to respond to unknown
communicable diseases that may emerge as future concerns.
The final rule updates the current definition of ill person to better focus on the
signs and symptoms of communicable diseases of public health concern and quarantinable
communicable diseases. The changes define an ill person in the context of the medical
resources available to the operator of an airline or vessel.
CDC already requests from pilots in command of aircraft and commanders of vessels
several of the symptoms included in the revised definition of ill person through publicly
available guidance to airlines and vessels. Moreover, for airlines, the updated definition
also better aligns with symptoms reporting guidelines published by ICAO in Note 1
to paragraph 8.15 of Annex 9 to the Convention on International Civil Aviation, and
the definition of “acute gastroenteritis” is used by the WHO and is currently included
in reporting guidance from CDC’s Vessel Sanitation Program. Therefore, CDC does not
anticipate additional burden on airlines or vessel operators to respond to these information
collections.
(2) CDC is requesting a change in the title of the information collection pertaining
to reports of death and illness from vessels to CDC. The former title is Radio Report of death or illness—illness reports from ships. CDC sought a change to remove “Radio” from the title.
This change reflects the fact that reports to CDC primarily via means other than radio,
such as the Maritime Illness and Death Reporting System, managed by CDC’s Vessel Sanitation
Program. CDC [*6966] did not receive any public comments to this change, and it is therefore finalized
as proposed.
(3) CDC is seeking a change in the title of a specific information collection pertaining
to reports of gastro-intestinal illness to CDC. CDC is updating the definition of
ill person and is replacing the term “gastro-intestinal” with “acute gastroenteritis”;
therefore, the title change is requested to align with the definition.
(4) CDC is seeking a change in title of respondents from “Maritime Conveyance Operator”
to “Maritime Vessel Operator” and from “Airline Commander or Operator” to “Pilot in
Command.”
Table 1 below presents estimates of annual burden (in hours) associated with each
reporting and recordkeeping requirement under this OMB control number, accounting
for the rule changes.
Description of Respondents. Respondents to this data collection include pilots in command of aircraft, maritime
vessel operators, importers/filers, and travelers/general public. The nature of the
response to HHS/CDC dictates which forms are completed and by whom. The total requested
burden hours are 82,779.
There is no burden to respondents other than the time taken to complete the reports
to CDC, maintain recordkeeping of illness aboard vessels and records of sickness or
death in imported cats and dogs, as outlined in the table below. If a cat or dog is
ill upon arrival, or dies prior to arrival, an exam is required, the initial exam
fee may be between $100 and $200. Rabies testing on a dog that dies may be between
$50 and $100. The expected number of ill or dead dogs arriving into the United States
for which CDC may require an examination is estimated at less than 30 per year.
Table 1—Estimated Annual Reporting Burden 0920-0134Type of respondent | Regulatory provision or form name | No. of respondents | No. of responses per respondent | Average burden per response (in hours) | Total burden hours |
Maritime Vessel Operators | 42 CFR 71.21(a) Report of illness or death from ships—Maritime Vessel Illness or Death Investigation
Form/Cumulative Influenza/Influenza-Like Illness (ILI) Form/Radio report or transcribed
email | 2,000 | 1 | 2/60 | 67 |
Pilot in Command | 42 CFR 71.21 (b) Death/Illness reports from aircraft | 1,700 | 1 | 2/60 | 57 |
Maritime Vessel Operators | 42 CFR 71.21(c) (MIDRS) Acute Gastro-Enteritis reports (24 and 4 hours before arrival) | 17,000 | 1 | 3/60 | 850 |
Maritime Vessel Operators | 42 CFR 71.21 (c) Recordkeeping-Medical logs | 17,000 | 1 | 3/60 | 850 |
Isolated or Quarantined individuals | 42 CFR 71.33 Report by persons in isolation or surveillance | 11 | 1 | 3/60 | 1 |
Maritime Vessel Operators | 42 CFR 71.35 Report of death/illness during stay in port | 5 | 1 | 30/60 | 3 |
Importer | 42 CFR 71.51(c)(1), (d)—Valid Rabies Vaccination Certificates | 245,310 | 1 | 15/60 | 61,328 |
Importer | CDC Form 75.37 Notice To Owners And Importers Of Dogs: Requirement for Dog Confinement | 1,400 | 1 | 10/60 | 233 |
Importer | 42 CFR 71.51(c)(i), (ii), and (iii) exemption criteria for the importation of a dog without a rabies
vaccination certificate | 43,290 | 1 | 15/60 | 10,823 |
Importer | 42 CFR 71.51(c)(2), (d) Application for a Permit to Import A Dog Inadequately Immunized Against Rabies | 1,400 | 1 | 15/60 | 350 |
Importer | 42 CFR 71.51(b) (3) Dogs/cats: Record of sickness or deaths | 20 | 1 | 15/60 | 5 |
Importer/Filer | 42 CFR 71.51_CDC Requested Data on Regulated Imports: Domestic Dogs and Cats (PGA Message Set) | 30,000 | 1 | 15/60 | 7,500 |
Importer | 42 CFR 71.52(d) Turtle Importation Permits | 5 | 1 | 30/60 | 3 |
Importers | 42 CFR 71.55, 42 CFR 71.32 Dead Bodies—Death certificates | 5 | 1 | 1 | 5 |
Importer | 42 CFR 71.56 (a)(2) African Rodents—Request for exemption | 20 | 1 | 1 | 20 |
Importer | 42 CFR 71.56(a)(iii) Appeal | 2 | 1 | 1 | 2 |
Importer/Filer | 42 CFR 71.56 CDC Requested Data on Regulation Imports: Live African Rodents (PGA Message Set) | 60 | 1 | 15/60 | 15 |
Importer/Filer | 42 CFR 71.32 Statements or documentation of non-infectiousness | 2,000 | 1 | 5/60 | 167 |
Importer/Filer | 42 CFR 71.56, 42 CFR 71.32 CDC Requested Data on Regulated Imports: Products of African Rodents; Products of
all Family Viverridae (PGA Message Set) | 2,000 | 1 | 15/60 | 500 |
Total | | | | | 82,779 |
The estimates are based on experience to date with current recordkeeping and reporting
requirements of
42 CFR part 71, with additional burden included to account for the potential for increased reports
of illness during an outbreak and for reports of disease that may have been missed
by airlines or vessels and are reported to CDC after travel.
Under this final rule, CDC is also requesting a nonmaterial/non-
[*6967] substantive change to Restrictions on Interstate Travel of Persons (
42 CFR part 70) (OMB Control No. 0920-0488). The regulations at
42 CFR part 70 are intended to prevent the interstate spread of disease, and include a requirement
that the master of vessel or person in charge of conveyance to report the occurrence
on board of communicable disease. Under this regulation and control number, CDC has
approval to collect the following information:
•
42 CFR 70.4 Report by the master of a vessel or person in charge of conveyance of the incidence
of a communicable disease occurring while in interstate travel.
Through this final rule, CDC is adding the provision 70.11
Report of death or illness onboard aircraft operated by airline, which specifies that the pilot in command of an aircraft operating on behalf of an
airline who conducts a commercial passenger flight in interstate traffic under a regular
schedule shall report as soon as practicable to HHS/CDC the occurrence onboard of
any deaths or ill persons among passengers or crew and take such measures as HHS/CDC
may direct to prevent the potential spread of the communicable disease. HHS/CDC notes
that it is changing the existing regulatory requirement at
42 CFR 70.4, which states that the master of a vessel or person in charge of any conveyance engaged
in interstate traffic on which a case or suspected case of communicable disease develops
shall, as soon as practicable, notify the local health authority.
Under the final rule, pilots in command of an aircraft, operating on behalf of an
airline, that submit the ill person or death report to HHS/CDC under new 70.11 will
not be required to also submit a report to the local health authority under current
70.4. HHS/CDC will continue to share public health information with State and local
health departments through electronic disease reporting networks. It is unlikely that
HHS/CDC would request follow-up reports of illnesses that are reported to the local
health authorities, unless there was an urgent public health need. Therefore, CDC
does not anticipate any additional burden to the respondents; however, the accounting
for burden in Table 2 will add 70.11 Report of death or illness onboard aircraft operated by airline.
As a result of this final rule, CDC does not anticipate a change in total burden.
CDC is instead allocating 95% of the reports of illness or death within the proposed
70.11 Report of death or illness onboard aircraft operated by airline. The remains 5% will remain within 70.4 Report by the master of a vessel or person
in charge of conveyance of the incidence of a communicable disease occurring while
in interstate travel, in the event that some reports are still made to State health
authorities.
In addition to the requirement to report directly to HHS/CDC, HHS/CDC is updating
the definition of “ill person” for the purposes of illness reports to HHS/CDC in
42 CFR part 70. HHS/CDC has, as a matter of agency guidance, communicated with airlines that the
same current set of required and requested signs and symptoms of disease, as well
as any death, apply to domestic as well as international flights. This guidance is
similar to that of the guidelines issued by ICAO under
Note 1 to paragraph 8.15 of Annex 9 to the Convention on International Civil Aviation. Therefore, the new proposed definition of ill person should not affect standard practice,
and no change in burden is anticipated.
Table 2 below presents estimates of annual burden (in hours) associated with each
reporting and recordkeeping requirement under this OMB control number, accounting
for the rule changes.
Respondents to this data collection include masters of vessels or persons in charge
of conveyance and pilots in command of aircraft.
Table 2—Estimated Annual Reporting Burden 0920-0488Type of respondent | Form name | No. of respondents | No. of responses per respondent | Average burden per response (in hours) | Total burden (in hours) |
Pilot in command | 42 CFR 70.11 Report of death or illness onboard aircraft operated by airline | 190 | 1 | 7/60 | 22 |
Master of vessel or person in charge of conveyance | 42 CFR 70.4 Report by the master of a vessel or person in charge of conveyance of the incidence
of a communicable disease occurring while in interstate travel | 10 | 1 | 7/60 | 1 |
Total | | 200 | | | 23 |
The total requested burden hours are 23. There is no burden to respondents other than
the time taken to complete the reports. The estimates are based on experience to date
with current recordkeeping and reporting requirements of
42 CFR part 70, and take into account the potential for additional burden from increased reports
of illness during an outbreak and for reports of disease that may have been missed
by respondents during travel and are reported to CDC by other means.
Finally, under this final rule HHS/CDC is requesting approval for a new information
collection, Airline and Vessel and Traveler Information Collection (
42 CFR part 71). This information collection request accompanies the codification of issuing orders
to airlines and vessel operators for the provision to CDC of airline and vessel and
traveler information (aka manifests) in the event that a quarantinable communicable
disease or a communicable disease of public health concern, or a death caused by a
quarantinable communicable disease or communicable disease of public health concern,
occurs during travel to the United States and public health follow-up is warranted.
These proposed provisions are found in
42 CFR 71.4 for airlines and 71.5 for vessels.
The ordering of manifests from airlines and vessel operators arriving into the United
States is an ongoing activity executed under CDC’s broad regulatory authority found
at
42 CFR 71.32 Persons, carriers, and things. To increase transparency with regard to CDC’s authorities and manifest order process,
CDC is proposing specific
[*6968] regulatory provisions that outline the particular data elements CDC requires to perform
contact tracing investigations. As stated in the final rule, CDC is not mandating
the collection of additional data. Only that if the airlines or maritime operators
have the data elements listed in 71.4 and 71.5 in their possession, they must be provided
to CDC within 24 hours.
Table 3 below presents estimates of annual burden (in hours) associated with each
reporting and recordkeeping requirement under this OMB control number, accounting
for the final rule changes.
Respondents to this data collection include the Airline Medical Officer or Equivalent
and a Computer and Information Systems Manager.
Table 3—Estimate of Annual Burden Airline and Vessel Manifest OrdersType of respondent | Form name | No. of respondents | No. of responses per respondent | Average burden per response (in hours) | Total burden (in hours) |
Airline Medical Officer or Equivalent/Computer and Information Systems Manager | International TB Manifest Template | 67 | 1 | 360/60 | 402 |
Airline Medical Officer or Equivalent/Computer and Information Systems Manager | International Non-TB Manifest Template. | 29 | 1 | 360/60 | 174 |
Total | | 96 | | | 576 |
The total requested burden hours included in this final rule is 576. There is no burden
to respondents other than the time taken to complete the manifest information and
send to CDC. The estimates are based on experience to date with current manifest order
process.
HHS/CDC has determined that the amendments to
42 CFR parts 70 and
71 will not have a significant impact on the human environment.
HHS/CDC has reviewed this rule under Executive Order 12988 on Civil Justice Reform
and determines that this final rule meets the standard in the Executive Order.
Under Executive Order 13132, a Federalism analysis is required if a rulemaking has
Federalism implications, would limit or preempt State or local law, or impose substantial
direct compliance costs on State or local governments. Under such circumstances, a
Federal agency must consult with State and local officials. Federalism implications
is defined as having substantial direct effects on State or local governments, on
the relationship between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government. 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 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. Additionally, there are no provisions in these
regulations that impose direct compliance costs on State and local governments. Therefore,
HHS/CDC believes that the rule does not warrant additional consultation under Executive
Order 13132.
Under
63 FR 31883 (June 10, 1998), Executive Departments and Agencies are required to use plain language
in all proposed and final rules. HHS/CDC received several comments suggesting that
the proposed regulation was not written in plain language and was therefore difficult
to understand. Prior to publication, this final rule was reviewed by specialists in
health communication and education to ensure the content and intention, as well as
substance, were clear and accurate.