[Federal Register Volume 73, Number 194 (Monday, October 6, 2008)]
[Rules and Regulations]
[Pages 58047-58058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23485]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
42 CFR Part 34
[Docket No. CDC-2008-0002]
RIN 0920-AA20
Medical Examination of Aliens--Revisions to Medical Screening
Process
AGENCY: Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services.
ACTION: Interim final rule with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), within
the U.S. Department of Health and Human Services (HHS), is amending its
regulations that govern medical examinations that aliens must undergo
before they may be admitted to the United States. HHS/CDC is amending
the definition of communicable disease of public health significance.
HHS/CDC is also amending the provisions that describe the scope of the
medical examination for aliens by incorporating a more flexible, risk-
based approach, based on medical and epidemiologic factors. This
approach will assist HHS/CDC in determining which diseases the medical
screening, testing, and treatment of aliens should include in areas of
the world that are experiencing unforeseen outbreaks of those diseases.
In addition, HHS/CDC is updating the screening requirements for
tuberculosis to be consistent with current medical knowledge and
practice.
These changes will reduce the health-security threat to the United
States from emerging diseases without imposing an undue burden on
either the aliens or the health-care system in U.S. resettlement
communities.
DATES: The interim rule is effective on October 6, 2008. Interested
parties must submit written comments on or before December 5, 2008.
HHS/CDC will consider comments received after this period only to the
extent practicable.
ADDRESSES: You may submit written comments, identified by Docket No.
CDC-2008-0002, to the following address: Division of Global Migration
and Quarantine, Centers for Disease Control and Prevention, U.S.
Department of Health and Human Services, ATTN: Part 34 Comments, 1600
Clifton Road, NE., E03, Atlanta, GA 30333.
Comments will be available for public inspection from Monday
through Friday, except for legal holidays, from 9 a.m. until 5 p.m.,
Eastern Time, at 1600 Clifton Road, NE., Atlanta, GA 30333.
Please call ahead to 1-866-694-4867, and ask for a representative
in the Division of Global Migration and Quarantine to schedule your
visit.
Comments are also available for viewing at the following Internet
addresses: http://www.cdc.gov/ncidod/dq and http://www.globalhealth.gov. You may submit written comments electronically
via the Internet at the following address: http://www.regulations.gov,
or via e-mail to [email protected].
To download an electronic version of the rule, please go to the
following Internet address: http://www.regulations.gov.
FOR FURTHER INFORMATION, CONTACT: Stacy M. Howard, Division of Global
Migration and Quarantine, Centers for Disease Control and Prevention,
U.S. Department of Health and Human Services, 1600 Clifton Road, NE.,
E03, Atlanta, GA 30333; telephone 404-498-1600.
SUPPLEMENTARY INFORMATION: The Preamble to this interim rule is
organized as follows:
I. Legal Authority
II. Background
III. Summary of Changes to 42 CFR Part 34
IV. Revised Definition of Communicable Disease of Public Health
Significance
V. Revised Scope of Medical Examination
VI. Updating Tuberculosis Screening Requirements
VII. Urgent Need for Regulatory Change
VIII. Analysis of Impacts
IX. Paperwork Reduction Act of 1995
X. References
I. Legal Authority
HHS/CDC is promulgating this rule under the authority of 42 U.S.C.
252 and 8 U.S.C. 1182 and 1222.
II. Background
Under section 212(a)(1) of the Immigration and Nationality Act
(INA) (8 U.S.C. 1182(a)(1)), any alien determined to have a specified
health-related condition is inadmissible to the United States. Those
aliens outside the United States with a specified health-related
condition (see below) are ineligible to receive a visa and ineligible
to be admitted into the United States. The grounds of inadmissibility
for specified health-related conditions also pertain to aliens in the
United States who are applying for adjustment of immigration status to
that of a lawful permanent resident.
Aliens are currently inadmissible into the United States if they
have a communicable disease of public health significance, defined as
follows: Active tuberculosis, infectious syphilis,
[[Page 58048]]
gonorrhea, infectious leprosy, chancroid, lymphogranuloma venereum,
granuloma inguinale, and HIV infection.
Medical examinations, including a physical and mental evaluation,
to determine whether an alien may have such a health-related condition,
are authorized under section 232 of the INA (8 U.S.C. 1222). Under
sections 212(a)(1) and 232 of the INA, and section 325 of the Public
Health Service (PHS) Act (42 U.S.C. 252), the Secretary of Health and
Human Services promulgates regulations to establish the requirements
for the medical examination and to list the health-related conditions
that make aliens ineligible for entry into the United States. The
regulations, administered by HHS/CDC, are promulgated at 42 FR part 34.
As currently listed in Sec. 34.1, the provisions in this part
apply to the medical examination of (1) aliens outside the United
States who are applying for an immigrant visa at an embassy or
consulate of the United States; (2) aliens arriving in the United
States; (3) aliens required by the U.S. Department of Homeland Security
(DHS) [formerly required by the Immigration and Naturalization Service
(INS)] to have a medical examination in connection with the
determination of their admissibility into the United States; and (4)
applicants in the United States who apply for adjustment of their
immigration status to that of permanent resident.
Panel physicians, designated by consular officers of the U.S.
Department of State, perform medical examinations abroad, and civil
surgeons, designated by the U.S. Citizenship and Immigration Services,
perform medical examinations for aliens who are already present in the
United States. Aliens determined to have a communicable disease of
public health significance may request a waiver to enter the United
States under sections 212(d)(3)(a) and 212(g) of the INA (8 U.S.C.
1182(d)(3)(a) and 1182(g)).
Aliens are inadmissible if they are determined: (1) To have a
communicable disease of public health significance; (2) to have a
physical or mental disorder and behavior associated with the disorder
that may pose, or has posed, a threat to the property, safety, or
welfare of the alien or others; (3) to have had a physical or mental
disorder and a history of behavior associated with the disorder, which
has posed a threat to the property, safety, or welfare of the alien or
others and which is likely to recur or lead to other harmful behavior;
or (4) to be a drug abuser or addict. In addition, except for certain
adopted children 10 years of age or younger, any alien who seeks
admission as an immigrant, or seeks adjustment of immigration status to
legal permanent resident, is inadmissible if the alien fails to present
documentation of having received vaccination against mumps, measles,
rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus
influenzae type B, hepatitis B and any other vaccination recommended by
the Advisory Committee for Immunization Practices.
Annually, the U.S. Government admits more than 1,000,000 immigrants
and refugees to reside permanently in this country. The majority
arrives from Asia, Africa and Central and South America, regions with
recently reported outbreaks of emerging, infectious diseases, including
yellow fever, dengue, Ebola and Marburg hemorrhagic fevers and the H5N1
strain of highly pathogenic avian influenza. These regular outbreaks,
many of which affect both urban and rural areas, and the movement of
large population resettlements from these regions, highlight the
serious threat to public health in the United States to which the
Centers for Disease Control and Prevention (CDC) within the U.S.
Department of Health and Human Services (HHS) has to respond on very
short notice.
In the recent past, the demographics of U.S.-bound refugees have
shifted to populations that are at higher risk for communicable
diseases. These newer groups of refugees have lower baseline rates of
vaccination, higher rates of parasitic infections and more limited
access to basic medical care and preventive health interventions before
resettlement. Between 1996 and 2003, at least half of all arriving
refugees were European. In 1998, 70 percent were European. Beginning in
2003, however, the numbers of refugees from Europe rapidly declined. In
2008, only three percent of all refugees arriving in the United States
were European. At the same time, a larger proportion of refugees have
come from countries with poorer economies, weaker health
infrastructure, and limited access to basic medical care. As a result,
these refugees have a higher incidence of major infectious diseases.
This demographic shift is one of the most important factors that
have led to the substantial increase in the number and nature of
outbreaks of communicable diseases that have affected refugee
resettlements. These new populations bring new diseases but the
diseases for which individuals are inadmissible into the United States
have remained much the same as at the end of the nineteenth century.
The highest rates of tuberculosis among immigrants and refugees are
for those born in sub-Saharan African and Southeast Asian countries,
with rates of at least 250 cases per 100,000. By comparison, the rate
in the United States is fewer than five cases per 100,000. Overall,
approximately one-third of the world's population has the infection,
and over 50 percent of TB cases in the United States are in foreign-
born residents.
Panel physicians miss up to 67 per cent of tuberculosis (TB) cases
based on the current scope of medical examination requirements.
Implementation of these revisions to the regulations would ensure the
methods for screening and testing TB used during the medical
examination of aliens reflect the most current medical practice.
The resettlement of these populations, many of which are coming
from high-risk countries, is a strong argument for an immediate
implementation of the changes in the list of communicable diseases of
public health significance to reduce the potential of emerging disease
threats in this higher-risk caseload. Urgent changes to this list are
needed to prevent importing communicable diseases into our country. The
current regulations do not address emerging and re-emerging diseases in
immigrant or refugee populations. HHS is adding diseases to the
communicable diseases of public health significance that better reflect
the true threats that our Nation faces, including cholera, diphtheria,
plague, smallpox, yellow fever, viral hemorrhagic fevers, and severe
acute respiratory syndrome (SARS). These diseases currently exist in
the list of quarantinable, communicable diseases defined by
Presidential Executive Order, but do not appear on the list of
communicable diseases of public-health significance. These diseases
cause severe illness and death in regions of the world that are home to
large numbers of immigrants and refugees bound for the United States.
In addition, the revision to part 34 is consistent with relevant
provisions of the revised International Health Regulations (2005),
which came into force in July of 2007.
HHS/CDC also issues technical instructions and provides technical
consultation and guidance to panel physicians and civil surgeons who
conduct the medical examinations of aliens. The HHS/CDC Technical
Instructions for Medical Examination of Aliens, including the most
current updates, which panel physicians and civil surgeons must follow
in accordance with these regulations, are
[[Page 58049]]
available to the public on the HHS/CDC Web site, located at the
following Internet address: http://www.cdc.gov/ncidod/dq/technica.htm.
HHS/CDC will also post and maintain a list of all medical conditions
and locations for which additional screening requirements are in effect
pursuant to this rule. This list will be available at the same Internet
address: http://www.cdc.gov/ncidod/dq/technica.htm, and http://www.globalhealth.gov.
III. Summary of Changes to 42 CFR Part 34
HHS/CDC is amending the definition of a communicable disease of
public health significance. Current communicable diseases of public
health significance are: active tuberculosis, infectious syphilis,
gonorrhea, infectious leprosy, chancroid, lymphogranuloma venereum,
granuloma inguinale, and HIV infection.
The definition of a communicable disease of public health
significance in this rule remains as those diseases currently listed in
Sec. 34.2(b), plus the addition of (1) quarantinable diseases
designated by Presidential Executive Order, and (2) those diseases that
meet the criteria of a public health emergency of international concern
which require notification to the World Health Organization (WHO) under
the revised International Health Regulations of 2005. A delay in
implementing these updates to Part 34 poses a risk of further severe
illness for refugees and immigrants as they move into receiving U.S.
communities and presents American taxpayers with elevated medical
costs. Updating the list of communicable diseases of public health
significance will diminish complex and costly measures such as
vaccination, chemoprophylaxis and isolation, and lessen illness and
death among the affected migrating populations.
The following is a section-by-section analysis of proposed changes:
Section 34.2 Definitions
The revision updates the definition provided in Sec. 34.2(b) for a
communicable disease of public health significance to include two new
categories of disease. The first category, added as Sec. 34.2(b)(2),
is the quarantinable, communicable diseases specified by the President
in Executive Order, as provided under Section 361(b) of the Public
Health Service Act. The second category, added as Sec. 34.2(b)(3), is
any communicable disease that requires notification to the World Health
Organization as an event that may constitute a public health emergency
of international concern, pursuant to the revised International Health
Regulations of 2005.
Section 34.3 Scope of Examinations
HHS/CDC is publishing section 34.3 in its entirety for clarity,
including republication of some provisions that are unchanged. HHS/CDC
has revised section 34.3 to include screening and testing for the
updated list of communicable diseases of public health significance, as
defined in Sec. 34.2(b). HHS/CDC has also revised section 34.3 to
require additional medical screening and testing using a more flexible
risk-based approach for those medical examinations performed outside of
the United States. HHS/CDC has also revised the specific requirements
concerning the required evaluation for tuberculosis.
The U.S. Department of Homeland Security (DHS) currently is the
entity responsible for administering the immigration authority and
functions previously administered by the Immigration and Naturalization
Service (INS), which was within the U.S. Department of Justice. The
revised rule text changes the reference to INS in existing Sec.
34.3(b)(2)(i) to U.S. Department of Homeland Security in new Sec.
34.3(e)(3)(i).
Specific Changes to the Scope of the Medical Examination, and the Risk-
Based Approach
The title of Sec. 34.3(b) has changed to Scope of all medical
examinations, and provides that all medical examinations will include a
general physical examination and medical history, evaluation for
tuberculosis, serologic testing for syphilis and HIV, and also a
physical examination and medical history for diseases specified in
Sec. Sec. 34.2(b)(1) and 34.2(b)(4) through 34.2(b)(10). The
unindented paragraph currently at the end of Sec. 34.3(a) has been
moved to Sec. 34.3(b)(2).
The title of Sec. 34.3(c) has been changed to Additional medical
screening and testing for examinations performed outside of the United
States and provides that HHS/CDC may require additional screening and
testing for medical examinations performed outside the United States
for diseases specified in Sec. Sec. 34.2(b)(2) and 34.2(b)(3) by
applying the risk-based medical and epidemiologic factors listed in
Sec. 34.3(d)(2). It provides that such examinations shall be conducted
in a defined population, in a geographic region or area outside the
United States, for a period of time as determined by HHS/CDC.
Additional medical screening and testing shall include a medical
interview, physical examination, laboratory testing, radiologic exam,
or other diagnostic testing as determined by HHS/CDC. Section
34.3(c)(4) and (5) indicate that additional medical screening and
testing will continue until HHS/CDC determines such activity is not
necessary, based on medical and epidemiologic factors, and that HHS/CDC
will provide medical examiners with information pertaining to all
additional screening and testing requirements, and will also post the
information on the HHS/CDC Web site.
Section 34.3(d) is entitled Risk-based approach, and provides the
medical and epidemiological factors that HHS/CDC will use to determine
whether a disease as specified in Sec. 34.2(b)(3)(ii) is a
communicable disease of public health significance, which diseases in
Sec. Sec. 34.2(b)(2) and (b)(3) merit additional screening and
testing, and the geographic area in which HHS/CDC will require this
screening. These factors include the seriousness of the disease's
public health impact; whether the emergence of the disease was unusual
or unexpected; the risk of the spread of the disease to the United
States; the transmissibility and virulence of the disease; the impact
of the disease at the geographic location of medical screening; and
other specific pathogenic factors that would bear on a disease's
ability to threaten the health security of the United States.
Specific Changes to Tuberculosis Screening Requirements
HHS/CDC has revised Sec. 34.3 to require testing for tuberculosis
of children under the age of 15 years old when they have symptoms of
tuberculosis, a history of tuberculosis, or possible exposure to a
transmissible tuberculosis case in a household or other enclosed
environment for a prolonged period. With regard to additional testing
requirements for an applicant that has a radiograph that indicates an
abnormality suggestive of tuberculosis disease, HHS/CDC has revised
Sec. 34.3 to require additional testing for tuberculosis. Specific
changes regarding the required evaluation for tuberculosis appear
below.
Section 34.3(b), entitled Persons subject to requirement for chest
x-ray examination and serologic testing is now Sec. 34.3(e). The
revision adds Sec. 34.3(e)(2)(ii) to include a chest x-ray examination
for applicants under 15 years of age if they have symptoms of
tuberculosis, a history of tuberculosis, or evidence of possible
exposure to a transmissible tuberculosis case in a household or other
enclosed
[[Page 58050]]
environment for a prolonged period. The paragraph describing
requirements for tuberculin skin test (TST) examination is now Sec.
34.3(e)(3), and has been renamed Immune response to Mycobacterium
tuberculosis antigens to reflect updated, current equivalent tests that
are increasingly used in clinical settings and may eventually be used
as an alternative to the tuberculin skin test for refugee and immigrant
screening. The Quantiferon-TB Gold (QFT-G) test is one recommended
method for screening for tuberculosis in clinical practice in most
circumstances instead of the TST. The incorporation of Immune Globulin
Release Assays (IGRAs), which include QFT-G, is under consideration by
CDC for screening for tuberculosis in aliens. This change will insure
that current, updated medical technology will be used, as appropriate,
by panel physicians and civil surgeons conducting the medical
examinations. This section also includes the addition of Sec.
34.3(e)(3)(iii) which requires a tuberculin skin test, or an equivalent
test for showing an immune response to Mycobacterium tuberculosis
antigens, for applicants outside of the United States who are required
to have a medical examination and, if indicated, a chest x-ray
examination, if the applicant is of sufficient age to be considered
contagious.
Section 34.3(e)(3)(iv) requires both a tuberculin skin test, or an
equivalent test for showing an immune response to Mycobacterium
tuberculosis antigens, and a chest x-ray examination for any applicant
outside of the United States, regardless of age, if the applicant has
symptoms of tuberculosis, a history of tuberculosis, or possible
exposure to a transmissible tuberculosis case in a household or other
enclosed environment for a prolonged period.
Section 34.3(e)(4), entitled Additional testing requirements,
indicates that all applicants subject to the chest x-ray examination
and for whom the radiograph shows an abnormality suggestive of
tuberculosis disease must undergo additional testing for tuberculosis.
This change allows for the use of the most current testing procedures
for tuberculosis disease.
References to the Attorney General in existing Sec. Sec.
34.3(b)(4) and (e) are changed to the Secretary of Homeland Security in
new Sec. Sec. 34.3(e)(5) and (h) to reflect the creation of DHS in
2003 and its assumption of applicable authorities and responsibilities.
Reference to INS in existing Sec. 34.3(b)(2)(i) is changed to U.S.
Department of Homeland Security in new Sec. 34.3(e)(3)(i). These
ministerial corrections are the only amendments to these sections which
are otherwise republished unchanged.
IV. Revised Definition of Communicable Disease of Public Health
Significance
As stated in Section 212(a)(1) of the INA, aliens are inadmissible
into the United States if they are determined to have a specified
health condition, which includes a communicable disease of public
health significance. Currently, medical examinations require the
screening of all aliens subject to these requirements for all listed
communicable diseases of public health significance. Regulations have
historically defined the term communicable disease of public health
significance by listing specific diseases. The current definition in 42
CFR 34.2(b) includes chancroid, gonorrhea, granuloma inguinale, human
immunodeficiency virus (HIV) infection, infectious leprosy,
lymphogranuloma venereum, infectious-stage syphilis, and active
tuberculosis.
Recent experience has demonstrated that a fixed list of diseases
does not allow HHS/CDC the flexibility it needs to rapidly respond to
unanticipated emerging or re-emerging outbreaks of disease. Rather,
HHS/CDC requires an approach based on potential risks and consequences
instead of a static list that does not reflect the potential for future
outbreaks of novel diseases. National and international health agencies
have recently developed guidelines for defining diseases of public
health significance that threaten global health security and require an
urgent response. This guidance provides the framework to update the
list of communicable diseases of public health significance for the
United States to screen and test aliens during disease outbreaks in
real time.
HHS/CDC is adding the following two disease categories to the
current list of communicable diseases of public health significance:
(1) Quarantinable, communicable diseases specified by Presidential
Executive Order, as provided under Section 361(b) of the Public Health
Service Act; and
(2) Any communicable disease that requires notification to the
World Health Organization as an event that may constitute a public
health emergency of international concern, pursuant to the revised
International Health Regulations of 2005.
Quarantinable Communicable Diseases Specified by Presidential Executive
Order, as Provided Under Section 361(b) of the Public Health Service
Act
Section 361 of the Public Health Service Act authorizes the
Secretary of HHS to enact rules and regulations for preventing the
introduction, transmission, and spread of communicable diseases from
foreign countries into the United States, and from one State or
possession into another. Executive Order 13295 of April 4, 2003, as
amended by Executive Order 13375 of April 1, 2005, contains the most
recent list of quarantinable, communicable diseases, and includes the
following: Cholera, yellow fever, plague, viral hemorrhagic fevers,
diphtheria, infectious tuberculosis, smallpox, severe acute respiratory
syndrome (SARS), and influenza caused by novel or re-emergent influenza
viruses that are causing, or have the potential to cause, a pandemic
(pandemic influenza). HHS/CDC is adding diseases listed by Presidential
Executive Order to the definition of communicable diseases of public
health significance, subject to screening and testing requirements
outlined in the section on the scope of examinations.
Any Communicable Disease That Requires Notification to the World Health
Organization as an Event That May Constitute a Public Health Emergency
of International Concern, Pursuant to the Revised International Health
Regulations of 2005
In May 2005, the World Health Assembly adopted the revised
International Health Regulations (IHR (2005)). These regulations
entered into force for most of the Member States of the WHO in June
2007 and for the U.S. in July 2007. The purpose and scope of the IHR
(2005) are to prevent, protect against, control and provide a public
health response to the international spread of disease, while
minimizing interference with world travel and trade. Annex 2 of the IHR
(2005) contains an algorithm for identifying a public health emergency
of international concern, and can be located at the following Internet
address: http://www.who.int/gb/ghs/pdf/IHR_IGWG2_ID4-en.pdf.
The IHR (2005) define a public health emergency of international
concern as an extraordinary event which is determined: (i) To
constitute a public health risk to other [Member] States through the
international spread of disease and (ii) to potentially require a
coordinated international response. Under the IHR (2005), Member States
must notify the World Health
[[Page 58051]]
Organization of any disease event that fulfills the criteria presented
in the three categories of the algorithm in Annex 2. The definition in
the revised part 34 rule text is intended to capture those diseases
that require notification by any country to the WHO under the IHR
(2005) and determined to be an event that may constitute a public
health emergency of international concern. The revised part 34 rule
text references IHR (2005) category (1), below, in Sec. 34.2(b)(3)(i),
and categories (2) and (3), below, together in Sec. 34.2(b)(3)(ii).
(1) Diseases Listed in the IHR (2005) for Which a Single Case Requires
Notification Through the Use of the IHR (2005) Algorithm
Annex 2 of the IHR (2005) specifies that smallpox, poliomyelitis
from wild-type poliovirus, pandemic influenza and severe acute
respiratory syndrome (SARS) are diseases with serious public health
impact, and that a single case, irrespective of context, requires
immediate notification to the WHO. HHS/CDC is adding diseases listed in
this category to the definition of a communicable disease of public
health significance, subject to screening and testing requirements
outlined in the section on the scope of examinations.
The impact of the SARS outbreak demonstrates the importance of
using the IHR (2005) algorithm to quickly detect and identify emerging
and re-emerging pathogens in this category. SARS coronavirus is a
droplet-spread illness that rapidly emerged as a global threat in 2003,
caused more than 8,000 cases and 800 deaths, and required isolation and
quarantine control measures. Although now contained, the disease (or
one similar to it) could re-emerge at any time. The use of the IHR
(2005) process for disease notification to the WHO will ensure the
earliest possible protection of citizens in the United States through
medical screening of a pathogen like SARS when the next outbreak
occurs. Smallpox, which causes high mortality and morbidity, is another
disease in this category. Because smallpox is now successfully
eradicated, it poses an ongoing threat as a bioterrorism agent.
(2) Other Diseases Listed in the IHR (2005) for Which Notification Is
Required Through the Use of the IHR (2005) Algorithm
In addition to the single-case notification diseases, Annex 2
indicates that an event that involves the following diseases shall
always lead to the use of the IHR (2005) algorithm to determine whether
the disease occurrence amounts to a public health emergency of
international concern, because these diseases have demonstrated the
ability to cause serious public health impact and to spread rapidly
internationally:
--Cholera;
--Pneumonic plague;
--Yellow fever;
--Viral hemorrhagic fevers (Ebola, Lassa, Marburg);
--West Nile fever; and
--Other diseases that are of special national or regional concern (e.g.
dengue fever, Rift Valley fever, and meningococcal disease).
HHS/CDC is adding diseases listed in this category to the
definition of a communicable disease of public health significance,
subject to screening and testing requirements and risk-based factors
outlined in the section on the scope of examinations.
Ongoing threats in this category include Ebola hemorrhagic fever, a
severe, often fatal disease, easily spread through close personal
contact. An outbreak of Ebola in the Democratic Republic of the Congo,
confirmed in September 2007, resulted in 26 laboratory-confirmed cases
of illness as of October 2007. There have been a total of 264 suspected
cases, and Ebola is believed to have killed up to 187 people over eight
months. A subsequent outbreak of Ebola in the Republic of Uganda
produced 149 suspect cases and killed 37 people. Cholera, which can
cause severe diarrhea and death, also continues to be active. From
August 2007 through November 2007, an outbreak spread throughout Iraq
and caused over 4500 cases of illness and 23 deaths.
(3) Other Unspecified Diseases That Require Notification Through the
Use of the IHR (2005) Algorithm
Annex 2 also refers to any event of potential international health
concern, including those of unknown causes or sources, and those that
involve events or diseases, other than the IHR (2005) single-case
notifiable and other specified notifiable diseases (listed in (1) and
(2) above), that lead to use of the IHR (2005) algorithm. HHS/CDC is
adding diseases listed in this category to the definition of a
communicable disease of public health significance, subject to
screening and testing requirements and risk-based factors outlined in
the section on scope of examinations. Addition of this last category to
the definition of diseases of public health significance allows HHS/CDC
to respond rapidly to emerging disease threats in a way that adding
specific diseases to a fixed list does not.
Once HHS/CDC acknowledges an event from the IHR (2005) algorithm as
a disease of public health significance, HHS/CDC will immediately
advise the physicians who conduct medical examinations of the
additional medical screening or testing required for the identified
disease(s) via electronic notification, coordination with embassies,
consulates and the International Organization for Migration, by
publication on the HHS/CDC Web site, and publication of a notice in the
Federal Register. HHS/CDC will also provide any required disease
notifications to appropriate DOS bureaus. HHS/CDC will also maintain a
current list of diseases and locations subject to additional medical
screening and will update addenda to the Technical Instructions for
Medical Examination of Aliens regarding these diseases, available to
the public on the HHS/CDC Division of Global Migration and Quarantine
Web site, located at the following Internet address: http://www.cdc.gov/ncidod/dq/technica.htm, and also at http://www.globalhealth.gov.
The HHS/CDC Division of Global Migration and Quarantine is the
current name of the former Division of Quarantine used in existing
Sec. 34.3(f), and section 34.3(i) of the revised rule text uses the
correct name. The section is otherwise republished unchanged.
V. Revised Scope of Medical Examination
HHS/CDC is amending the scope of the medical examination in 42 CFR
34.3 to allow greater agility to respond to significant outbreaks of
communicable diseases of public health significance for applicants
examined in geographic locations where these diseases exist, and for
which importation into the United States would pose a threat. HHS/CDC
believes a risk-based approach that uses medical and epidemiologic
factors to detect additional diseases of public health significance
provides a flexible, fair and practical means to address infectious
disease threats among at-risk aliens without placing an undue burden on
other applicants.
Beginning on the effective date of this rule, HHS/CDC will also
make a distinction between the medical examinations performed for
aliens outside the United States, and those performed for aliens
already in the United States who are applying for adjustment of status
to that of permanent resident, in that the risk-based approach to
detect additional diseases of public health significance will apply
only to medical examinations outside the United States and only in
those geographic areas where the risk is high. Applicants already
within the United States who apply for adjustment
[[Page 58052]]
of immigration status will not be subject to additional screening or
testing using the risk-based approach. Disease outbreaks in aliens who
are within the United States primarily fall under the jurisdiction of
state and local public health authorities. For both groups of aliens,
those applying for status adjustment from within the United States and
those applying for admission from outside the United States, the
medical screening examination will continue to consist of a general
physical examination and medical history, evaluation for tuberculosis,
and serologic testing for syphilis and HIV. In addition, under the new
risk-based approach, HHS/CDC may require aliens outside the United
States applying for U.S. immigration to undergo additional screening
and testing for specific communicable diseases of public health
significance.
Quarantinable, Communicable Diseases Specified by Presidential
Executive Order as Provided Under Section 361(b) of the Public Health
Service Act
Medical screening for these diseases will be achieved through
physical examination and medical history. Accomplish HHS/CDC may
require additional screening or testing for these diseases for aliens
receiving medical examinations at the specific location or area where
outbreaks of the disease or diseases may be occurring. This additional
screening and testing will involve applying the defined risk-based
approach by using medical and epidemiologic factors (shown below in
this section.)
This change addresses diseases in immigrant and refugee populations
(and, in extreme cases, non-immigrant aliens) outside the United
States, and ensures the lists of quarantinable diseases and
inadmissible conditions remain consistent. Whenever this Executive
Order is amended in the future to add additional diseases, HHS/CDC will
be able to immediately begin testing and screening for these diseases.
Any Communicable Disease That Requires Notification to the World Health
Organization as an Event That May Constitute a Public Health Emergency
of International Concern, Pursuant to the Revised International Health
Regulations of 2005
(1) Diseases Under the IHR (2005) for Which a Single Case Requires
Notification to WHO as an Event That May Constitute a Public Health
Emergency of International Concern
HHS/CDC will consider all the diseases in this category, including
diseases included by WHO in the future, as communicable diseases of
public health significance and subject to medical screening through
physical examination and medical history. HHS/CDC will also consider
imposing additional screening and testing, as determined by the
specific circumstances of the event, for diseases in this category that
meet requirements of the risk-based approach composed of medical and
epidemiologic factors (shown below in this section) and for which HHS/
CDC determines a threat exists for importation into the United States,
and that may potentially affect the health of the American public.
(2) Other Diseases That Require Notification to WHO as an Event That
May Constitute a Public Health Emergency of International Concern
Through the Use of the IHR (2005) Algorithm (Includes Categories (2)
and (3) of the IHR (2005) Algorithm Referenced Previously in Section
IV--Revised Definition of a Communicable Disease of Public Health
Significance)
HHS/CDC will consider the diseases in this category as communicable
diseases of public health significance and subject to medical screening
through physical examination and medical history if they meet one or
more of the risk-based criteria of medical and epidemiologic factors
(shown below in this section), and HHS/CDC determines (1) a threat
exists for importation into the United States, and (2) such diseases
may potentially affect the health of the American public. HHS/CDC will
also consider imposing additional screening and testing for diseases in
this category, as determined by the specific circumstances of the
event.
Risk-Based Approach of Medical and Epidemiologic Factors
HHS/CDC will determine which diseases merit additional screening
and testing, and the geographic area in which HHS/CDC will require this
screening, by applying a risk-based approach that takes into account
the following medical and epidemiologic factors: (a) The seriousness of
the disease's public health impact; (b) whether the emergence of the
disease was unusual or unexpected; (c) the risk of the spread of the
disease to the United States; (d) the transmissibility and virulence of
the disease; (e) the impact of the disease at the geographic location
of medical screening; and (f) other, specific pathogenic factors that
would bear on a disease's ability to threaten the health security of
the United States. HHS/CDC will consider diseases identified through
the International Health Regulations algorithm (other than diseases for
which a single case requires notification) as communicable diseases of
public health significance when they meet one or more of the criteria
listed above, and for which HHS/CDC determines (A) a threat exists for
importation into the United States, and (B) such diseases may
potentially affect the health of the American public.
This risk-based approach will facilitate a meaningful public health
response to existing and emerging threats, without overwhelming the
entire health system with needless testing. The changes to the scope of
the examination will allow HHS/CDC to tailor testing requirements to
those areas where the severity of communicable diseases of public
health concern are actually affecting populations at the time of the
medical examination.
When HHS/CDC requires screening for additional communicable
diseases of public health significance for applicants from specific
geographic areas, HHS/CDC may require additional screening, including
additional medical interviews, a physical examination, laboratory
testing, radiologic exams, or other diagnostic procedures.
Screening and testing for newly identified diseases as a part of
the list of communicable diseases of public health significance will
continue until HHS/CDC determines the particular situation does not
warrant this designation, based on factors such as the results of
disease investigations; response efforts; the effectiveness of
containment and control measures; and the current determination or
termination of the public health emergency of international concern by
the Director General of the WHO.
HHS/CDC will provide physicians the technical instructions
regarding the required additional medical screening and testing to
perform for a disease as part of the examination. In most instances,
additional medical screening and testing may only consist of
epidemiologic questions and further physical examination relating to
the disease. HHS/CDC will also update the Technical Instructions for
Medical Examination of Aliens, as needed, regarding the additional
medical screening and testing protocol for a disease, and this
information will also be immediately available to the public on the
HHS/CDC Division of Global Migration and Quarantine Web site, located
at the following Internet address: http://www.cdc.gov/ncidod/dq/technica.htm; and at http://www.globalhealth.gov. A listing of current
documents regarding the
[[Page 58053]]
additional medical screening and testing protocol for specific diseases
will also be available on the HHS/CDC Web site.
VI. Updating Tuberculosis Screening Requirements
HHS/CDC is amending the medical examination rule for aliens by
updating the screening requirements for tuberculosis, to be consistent
with current medical knowledge and practice. HHS/CDC is amending 42 CFR
34.3(b) by revising the requirement for a chest X-ray examination to
include applicants under the age of fifteen years old, when there is
reason to suspect tuberculosis infection. The practical effect of this
change is to expand this testing protocol to alien applicant children
under the age of 15, when medically appropriate. This change will allow
HHS/CDC the flexibility to ensure the tuberculosis screening and
testing methods used for medical examination of aliens are current and
effective.
HHS/CDC is amending Sec. 34.3(b)(1)(v) by adding the expanded
tuberculin skin test requirement, or an equivalent test for showing an
immune response to Mycobacterium tuberculosis antigens, to the
exceptions that may be authorized for good cause upon application
approved by the Director of CDC.
HHS/CDC is amending Sec. 34.3(b)(2) to indicate that any alien
applicant outside the United States shall have a tuberculin skin test
or an equivalent test for showing an immune response to Mycobacterium
tuberculosis antigens and, if indicated, a chest X-ray examination if
the applicant is of sufficient age to be considered contagious.
Additionally, any alien applicant outside the United States, regardless
of age, shall have both a tuberculin skin test or an equivalent test
for showing an immune response to Mycobacterium tuberculosis antigens,
and a chest X-ray examination if the applicant has symptoms of
tuberculosis disease, has a history of tuberculosis, or has exposure to
a transmissible tuberculosis case in a household or other enclosed
environment for a prolonged period. HHS/CDC is amending this section to
make it consistent with current medical knowledge and practice.
HHS/CDC is amending Sec. 34.3 by adding a new provision, entitled
Additional Testing Requirements, with the following rule text: All
applicants subject to the chest X-ray examination requirement and for
whom the radiograph shows an abnormality suggestive of tuberculosis
disease shall be required to undergo additional testing for
tuberculosis disease.
The current, outdated rule requires sputum smears for anyone with
signs, or x-ray findings, suggestive of tuberculosis. Current medical
guidelines require mycobacterial culture, which is three times as
sensitive as a sputum smear for detecting active tuberculosis.
HHS/CDC is also updating language in 34.3(e) and (f) to replace x-
ray film with x-ray image. This change is needed to reflect updated
radiology technology such as CD-R and laser-printed x-ray formats.
Language concerning chest x-rays being attached to the alien's visa in
such a manner to be readily detached at the U.S. port of entry has also
been deleted since x-rays are not required to be presented at the port
of entry.
VII. Urgent Need for Regulatory Change
The U.S. Department of State proposed 80,000 refugee admissions for
Fiscal Year 2008 under the requirements of Section 207(e)(1)-(7) of the
Immigration and Nationality Act. This is greater than a ten percent
increase from FY 2007 projections. As of June 2008, approximately
35,000 refugees have been resettled, and around 27,000 still expected
by the end of September 2008. Major diseases of concern in these
incoming refugee populations include multi-drug-resistant tuberculosis
(MDR TB), measles, highly pathogenic avian influenza, and cholera. The
potential for transmitting viral hemorrhagic fevers, such as Ebola and
Marburg, also exists among some of the African populations being
resettled. In addition, several vector-borne (animal-transmitted)
diseases including chikungunya, dengue and, possibly, Rift Valley
fever, are circulating in refugee camps with populations bound for the
United States. Vectors (i.e. mosquitoes) prevalent in the United States
are capable of widely spreading these diseases.
Allowing serious diseases to enter into the United States can
result in significant harm to both the American public and American
business. The existing definition of communicable diseases of public
health significance and the evaluation criteria for tuberculosis in the
current regulation are outdated and no longer in keeping with current
medical knowledge. Therefore, immediate changes are needed to improve
the ability of the United States to prevent the introduction and spread
of infectious diseases that are currently causing severe illness and
death abroad. The scope of examination for medical screening is also
outdated, and needs immediate changes to allow for medical screening by
using a risk-based approach that considers medical and epidemiologic
factors. The current regulations do not have a process for allowing
HHS/CDC to adapt rapidly to new health threats, and they reference
outdated public health practices that do not take advantage of the
latest biomedical knowledge and epidemiologic data. Changes are needed
now to reduce the potential for significant harm from emerging diseases
and outbreaks of infectious diseases that currently threaten U.S.
health security.
Newly emerging communicable disease threats are arising with
increased frequency because of multiple factors, such as increases in
global travel and mobility, migration patterns, human susceptibility to
novel infections, and microbial adaptation and mutation, as cited in
the latest report of the U.S. Institute of Medicine on emergence of
infectious diseases, Microbial Threats to Health: Emergence, Detection
and Response, National Academies Press, 2003. Infectious disease
outbreaks (e.g., SARS in 2003) or potential threats like pandemic
influenza are evidence that virulent diseases with short incubation
periods can be carried over a border before signs of illness can be
observed. Additionally, when disease outbreaks occur in refugees or
immigrants coming to the United States, public health control actions
such as vaccination, treatment, chemoprophylaxis and isolation must be
implemented immediately to prevent the importation of disease into the
United States.
Annually, approximately 1,000,000 immigrants and refugees enter the
United States to reside here permanently. The majority arrive from
Asia, Africa and Central and South America, regions with recently
reported outbreaks of emerging infectious diseases, including yellow
fever, dengue and the H5N1 strain of avian influenza. The 50,000-80,000
refugees who resettle in the United States each year are the most
vulnerable populations, as they often come from difficult environmental
conditions with limited water, sanitation and health care. Living
conditions for many refugees include poor to nonexistent health and
public health infrastructure; thus, it is difficult to have adequate
knowledge of their current and potential medical problems. In refugee
camps, disease surveillance and laboratory resources are often limited,
which increases the difficulty of maintaining good health and
preventing outbreaks of infectious diseases. Historically, outbreaks of
communicable diseases have occurred frequently in refugee camps. These
regular outbreaks, and the inherent nature of large population
resettlements, highlight the health threats to which
[[Page 58054]]
HHS/CDC has to respond on very short notice.
The shift in the demographics of refugee and immigrant populations
bound for the United States and consequent changes in their health
risks mandate a change in the definition of a communicable disease of
public health significance, because of the current uncertainty of
global disease trends. This demographic shift is the single most
important cause of the substantial increase in the number and nature of
outbreaks of communicable diseases among immigrants who are resettling
into the United States.
HHS/CDC is unable to forecast constantly changing migration
patterns, and thus must have the flexibility to respond swiftly as
unpredictable, problematic health and humanitarian crises arise. The
current definition of a communicable disease of public health
significance does not adequately accommodate the demographic shifts
that have dramatically altered the pattern of diseases among new
arrivals in the United States.
HHS/CDC has found that the origins of U.S.-bound populations are
increasingly unpredictable, and these populations increasingly
originate in areas with challenging and unpredictable communicable
diseases of public health significance. Immigration statistics (http://www.dhs.gov/ximgtn/statistics) show more U.S.-bound refugees and
immigrants now come from regions with a higher risk for communicable
diseases. In recent years, the disease burden to the United States has
increased as the proportion of refugees resettling from Africa and Asia
has increased (http://www.state.gov/g/prm/refadm/rls/85970.htm). As an
example, the proportion of refugees resettled to the United States from
Africa have increased in the recent past. African refugee arrivals have
averaged 16,000 per year since FY 2005. These newer groups of refugees
have lower baseline rates of vaccination, higher rates of malaria and
other parasitic infections (unfamiliar to most American clinicians),
and very limited access to basic medical care and preventive health
interventions before resettlement. Failure to address these conditions
adequately because of the outdated definition of communicable diseases
of public health significance has meant that HHS/CDC has had to respond
to at least 25 outbreaks of disease among U.S.-bound refugees since
2004.
Major outbreaks of dangerous, communicable diseases around the
world in 2007 included Ebola in the Democratic Republic of the Congo in
September, and in Uganda in December; cholera in Iraq in August; yellow
fever in Togo in February, and in Brazil and Paraguay in December; and
85 animal-to-human cases of the highly pathogenic H5N1 strain of avian
influenza throughout the year. These outbreaks have been of diseases
that do not naturally occur in the United States, or occur rarely,
which could result in disability and death in U.S.-bound immigrants and
refugees and secondary spread in the communities in the United States
that receive immigrants.
The WHO classifies yellow fever as a disease that has demonstrated
the ability to cause serious public health impact, and is a good
example of a threat to the health security of the United States. The
Ministry of Health in Togo reported an outbreak of yellow fever to the
WHO that lasted from December 2006 through February 2007. Moreover,
Sudan, Senegal, Mali, C[ocirc]te d'Ivoire, Burkina Faso, Guinea,
Brazil, Peru, Paraguay, Bolivia and Argentina have also reported
ongoing outbreaks of yellow fever to the WHO. In total, the WHO
considers 46 countries, including 33 African countries and 11 countries
in Central and South America, to be currently at risk of yellow fever.
Substantial numbers of U.S.-bound immigrants and refugees originate
from areas in which yellow fever is endemic, and therefore pose a risk
of the importation of this disease. Since mosquitoes that spread yellow
fever exist in the United States, and areas of our country experienced
outbreaks of the disease throughout the nineteenth century, importation
could potentially result in sustained transmission in this country.
Yellow fever is not currently included in the specific disease list in
the regulation, but HHS/CDC would be classify it as a communicable
disease of public health significance under the newly proposed
definition, because it is a quarantinable disease by Presidential
Executive Order and a disease that requires notification to WHO as an
event that may constitute a public health emergency of international
concern under the IHR (2005).
The examples below enumerate some of the most recent (and largely
unpredictable) disease outbreaks encountered as refugees resettle into
the United States:
--March 2007 to the present: Imported malaria outbreak in Burundian
refugees from Tanzania. Over 40 cases of malaria have occurred as of
October 2007 in more than 12 U.S. states, including 18 cases in
children less than 10 years old, despite the administration of a pre-
departure drug treatment regimen. Single cases or small domestic
outbreaks through mosquitoes are another potential risk from this
outbreak.
--October 2007 to the present: at least 12 cases of cholera have been
reported in several thousand U.S.-bound refugees from the Dadaab
refugee camp in Kenya, which led to a temporary suspension of
resettlement. This was the second outbreak of cholera in this camp in
2007; an earlier outbreak affected more than 200 refugees in June 2007.
--July 2007 to the present: cholera in Mae La refugee camp in Thailand,
with over 200 cases reported as of October 2007.
--April to June 2007: 288 cases of cholera were reported in Dadaab
refugee camp in Kenya. These cases included four deaths and
necessitated a five-day holding period for U.S.-bound refugees before
travel.
--January to May 2007: A measles outbreak affected over 100 persons in
Dadaab refugee camp in Kenya and showed unusual epidemiology: 43
percent of cases were in persons 15 years of age and older (measles
usually affects only children, and thus most vaccination campaigns only
cover those under 5 years of age).
--November 2006 to May 2007: Rift Valley Fever in Kenya (including in
the Dadaab camp), Somalia, and the United Republic of Tanzania, with
over 300 deaths.
--October 2006: A case of polio reported in the Dadaab refugee camp in
Kenya, in the first reported local transmission of wild poliovirus for
over 20 years in Kenya; only quick action by HHS/CDC avoided the
importation of wild poliovirus (WPV) into the United States. (The last
indigenous case of WPV in the United States was in 1979, and the last
imported case of WPV was in 1993.)
Vector-borne diseases involve a pathogen transmitted from an
infected individual or animal, usually by an insect or other arthropod
such as a mosquito or tick. There are several vector-borne diseases
that are circulating in areas with U.S.-bound immigrants and refugees,
all of which could spread into the U.S. population. These include
exotic illnesses like chikungunya, dengue, and possibly Rift Valley
fever.
Pandemic Influenza
The changes in the medical screening rules will also provide HHS/
CDC officials with the authority to screen applicants that are coming
into the United States from areas affected by a possible pandemic
influenza. The World Health Report 2007--A safer future: global public
health security in the 21st
[[Page 58055]]
century, issued by the WHO, emphasizes the danger of an influenza
pandemic. A pandemic strain of influenza would be far more contagious
than SARS, since it spreads by coughing and sneezing, and is
transmitted with a short incubation period that reduces the time for
tracing the spread of disease and isolating patients. An influenza
pandemic could extend the enormous health consequences seen with SARS
in Asia and Canada to every corner of the world within a matter of
months.
Although HHS/CDC cannot predict the timing and exact strain,
science and history suggest the world will suffer at least one
influenza pandemic this century, which has the potential to have a
rapid and immense impact on all segments of the U.S. population and our
economy. In the 20th century, the greatest influenza pandemic occurred
in 1918-1919, which caused an estimated 40-50 million deaths worldwide.
A severe pandemic, as happened in 1918, could now have a much greater
impact. When pandemic strains emerge, they sweep through nations with
frightening velocity. The three pandemics of the 20th century each
encircled the world within months of their emergence into humans. Based
on the current speed and volume of international movement of people and
animals, there is no reason to think the next pandemic would spread any
slower.
Although health care has improved in the past decades, the WHO is
predicting that today an influenza pandemic could result in 2-7.4
million deaths globally. \1\ The WHO estimates that if a pandemic virus
emerged now, the spread of the disease would be rapid. Based on
experiences with past pandemics, some experts have predicted an illness
that could affect around 25 percent of the world's population--more
than 1.5 billion people. Should these forecasts prove accurate, the
impact an influenza pandemic would have on national and international
public health, and on economic and political security, would be
enormous. Even if the virus caused relatively mild symptoms, the
economic and social disruption that would arise from sudden surges of
illness in so many people--occurring almost simultaneously throughout
the world--would be incalculable.\2\
---------------------------------------------------------------------------
\1\ Pandemic influenza preparedness and mitigation in refugee
and displaced populations, WHO guidelines for humanitarian agencies,
May 2006.
\2\ The World Health Report 2007--A safer future: global public
health security in the 21st century, WHO, August 2007.
---------------------------------------------------------------------------
Interpandemic (seasonal) influenza results in more than 200,000
hospitalizations every year and causes an average of 36,000 deaths
annually in the United States. Modeling studies suggest that, in the
absence of effective control measures, a medium-level pandemic (in
which 15 to 35 percent of the population of the United States develops
influenza) could result in 89,000 to 207,000 deaths, between 314,000
and 734,000 hospitalizations, 18 to 42 million outpatient visits, and
20 to 47 million sick people. The associated economic impact in the
United States alone could range between $71.3 and $166.5 billion.
The H5N1 virus that is currently circulating in Asia, Africa and
Europe provides an example of the immense potential impact of an
emerging influenza virus. As of March 19, 2008, the H5N1 strain of
influenza virus has killed over 63 percent of the 373 humans affected,
and authorities fear the disease could mutate into a form that could
pass quickly and efficiently from human to human, which could spark a
global pandemic. The 14 countries that have reported laboratory-
confirmed human cases of H5N1 infection as of March 19, 2008, are
Azerbaijan, The People's Republic of China, Djibouti, Thailand, Egypt,
Vietnam, Cambodia, Indonesia, Laos, Nigeria, Pakistan, Burma, Turkey,
and Iraq. Before the next pandemic virus becomes well-adapted to
humans, there is an urgent need for the United States to be prepared to
detect human cases, and to prevent a novel influenza virus from being
imported to the United States. One of the most effective ways to
protect the American population is the preventive medical screening of
aliens which would thereby help avert the entry and importation of a
pandemic strain, or at least delay its arrival.
HHS/CDC is implementing these new provisions immediately because
the United States needs to respond effectively to any potential
emerging communicable disease. HHS/CDC is taking this immediate action
because the existing definition of communicable diseases of public
health significance and the scope of medical screening do not
adequately reflect current threats or protect against the significant
harm to the American public currently ongoing and future outbreaks
represent. Changing our approach to identifying, screening and testing
for communicable diseases of public health significance will greatly
improve our ability to detect, treat, and mitigate the potential
introduction into--and spread throughout our country--of newly emerging
and re-emerging diseases.
Under the provisions of the Administrative Procedure Act at 5
U.S.C. 553(b)(3)(B) and (d)(3), HHS/CDC finds that good cause exists to
waive prior notice and comment and a 30 day delay in effective date on
this rule is impracticable and contrary to the public interest. It is
critical, for the reasons stated above, that HHS/CDC act quickly to
ensure appropriate response, now and in the immediate future, to urgent
disease threats that could have significant consequences in the United
States. As noted, CDC is eager to consider public comment and will
revise the rule as appropriate after receiving and analyzing any
comments submitted.
VIII. Analysis of Impacts
A. Review Under Executive Order 12866, the Regulatory Flexibility Act,
and the Unfunded Mandates Act of 1995
HHS/CDC has examined the impact of the Interim Final Rule under
Executive Order 12866, the Regulatory Flexibility Act, and the Unfunded
Mandates Reform Act (UMRA) of 1995.
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits.
HHS/CDC commissioned an analysis of the rule, which is included in
the docket. The analysis examined the increased costs to immigrants,
refugees and other entities, and the benefits of additional screening
in preventing the spread of disease in the U.S. population.
Based on recent history of disease outbreaks worldwide, the
analysis estimates an additional cost of $4 million per year to
immigrants and refugees. Immigrants will bear the additional medical
testing costs for themselves, and the U.S. government will bear the
additional medical testing costs for refugees. The benefit to the U.S.
population associated with reduced incidence of secondary infections is
estimated to be $30 million.
These estimates only reflect the costs and benefits based on recent
history. The study examined the benefits and costs associated with a
new or re-emerging disease separately, but did not include them in the
annualized values because of the inherent inability to estimate the
frequency of an unknowable event.
Based on the analysis, HHS/CDC has determined that the rule is not
economically significant, as defined under Executive Order 12866.
HHS/CDC considered the proposed regulation's effects on small
entities, as required by the Regulatory Flexibility Act, and certifies
that the final rule will
[[Page 58056]]
not have a significant economic impact on small entities.
HHS/CDC evaluated the rule requirements for compliance with the
UMRA of 1995. This rule does not contain Federal mandates under the
regulatory provisions of Title II of the UMRA for State, local or
tribal governments, nor for the private sector. Finally, the rule's
provisions will not affect small governments.
B. Environmental Impact
HHS has determined that provisions that amend 42 CFR part 34 will
not have a significant impact on the human environment.
C. Federalism
In accordance with Executive Order 13132, HHS/CDC determines that
this rule does not have sufficient federalism implications to warrant
the preparation of a federalism summary impact statement.
D. Civil Justice Reform
HHS/CDC has reviewed this rule under Executive Order 12988, on
Civil Justice Reform. This rule (1) preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court to challenge this rule.
IX. Paperwork Reduction Act of 1995
The Paperwork Reduction Act applies to the data collection
requirements found in 42 CFR part 34. The U.S. Department of State
(DoS) is responsible for providing forms to panel physicians to
document the medical examination and screening information for aliens.
The Office of Management and Budget (OMB) last approved this data
collection under OMB Control No. 1405-0113, on September 30, 2007. DoS
will update its information collection request to reflect the changes
made to the forms by this Interim Final Rule.
X. References
The following references are available at the following Internet
address: http://www.who.int.
1. Pandemic influenza preparedness and mitigation in refugee and
displaced populations, WHO guidelines for humanitarian agencies, May
2006.
2. The World Health Report 2007--A safer future: global public
health security in the 21st century, WHO, August 2007.
List of Subjects in 42 CFR Part 34
Aliens, Health Care, Scope of Examination, Passports and Visas,
Public Health.
0
For the reasons stated in the preamble, the Centers for Disease Control
and Prevention (CDC), within the U.S. Department of Health and Human
Services (HHS), is amending 42 CFR part 34 as follows:
PART 34--[AMENDED]
0
1. The authority citation for part 34 is amended to read as follows:
Authority: 42 U.S.C. 252; 8 U.S.C. 1182 and 1222.
0
2. Amend Sec. 34.2 by revising paragraph (b) to read as follows:
Sec. 34.2 Definitions.
* * * * *
(b) Communicable disease of public health significance. Any of the
following diseases:
(1) Chancroid.
(2) Communicable diseases as listed in a Presidential Executive
Order, as provided under Section 361(b) of the Public Health Service
Act. The current revised list of quarantinable communicable diseases is
available at http://www.cdc.gov and http://www.archives.gov/federal-register.
(3) Communicable diseases that may pose a public health emergency
of international concern if it meets one or more of the factors listed
in Sec. 34.3(d) and for which the CDC Director has determined (A) a
threat exists for importation into the United States, and (B) such
disease may potentially affect the health of the American public. The
determination will be made consistent with criteria established in
Annex 2 of the revised International Health Regulations (http://www.who.int/csr/ihr/en/), as adopted by the Fifty-Eighth World Health
Assembly in 2005, and as entered into effect in the United States in
July, 2007, subject to the U.S. Government's reservation and
understandings:
(i) Any of the communicable diseases for which a single case
requires notification to the World Health Organization (WHO) as an
event that may constitute a public health emergency of international
concern, or
(ii) Any other communicable disease the occurrence of which
requires notification to the WHO as an event that may constitute a
public health emergency of international concern.
HHS/CDC's determinations will be announced by notice in the Federal
Register.
(4) Gonorrhea.
(5) Granuloma inguinale.
(6) Human immunodeficiency virus (HIV) infection.
(7) Leprosy, infectious.
(8) Lymphogranuloma venereum.
(9) Syphilis, infectious stage.
(10) Tuberculosis, active.
* * * * *
0
3. Section 34.3 is revised to read as follows:
Sec. 34.3 Scope of examinations.
(a) General. In performing examinations, medical examiners shall
consider those matters that relate to the following:
(1) A communicable disease of public health significance;
(2)(i) A physical or mental disorder and behavior associated with
the disorder that may pose, or has posed, a threat to the property,
safety, or welfare of the alien or others;
(ii) A history of a physical or mental disorder and behavior
associated with the disorder, which behavior has posed a threat to the
property, safety, or welfare of the alien or others and which behavior
is likely to recur or lead to other harmful behavior;
(3) Drug abuse or addiction; and
(4) Any other physical abnormality, disease, or disability serious
in degree or permanent in nature amounting to a substantial departure
from normal well-being.
(b) Scope of all medical examinations. (1) All medical examinations
will include the following:
(i) A general physical examination and medical history, evaluation
for tuberculosis, and serologic testing for syphilis and HIV.
(ii) A physical examination and medical history for diseases
specified in Sec. Sec. 34.2(b)(1), and 34.2(b)(4) through 34.2(b)(10).
(2) The scope of the examination shall include any laboratory or
additional studies that are deemed necessary, either as a result of the
physical examination or pertinent information elicited from the alien's
medical history, for the examining physician to reach a conclusion
about the presence or absence of a physical or mental abnormality,
disease, or disability.
(c) Additional medical screening and testing for examinations
performed outside the United States. (1) HHS/CDC may require additional
medical screening and testing for medical examinations performed
outside the United States for diseases specified in Sec. Sec.
34.2(b)(2) and 34.2(b)(3) by applying the risk-based medical and
epidemiologic factors in paragraph (d)(2) of this section.
(2) Such examinations shall be conducted in a defined population in
a geographic region or area outside the United States as determined by
HHS/CDC.
[[Page 58057]]
(3) Additional medical screening and testing shall include a
medical interview, physical examination, laboratory testing, radiologic
exam, or other diagnostic procedure, as determined by HHS/CDC.
(4) Additional medical screening and testing will continue until
HHS/CDC determines such screening and testing is no longer warranted
based on factors such as the following: Results of disease outbreak
investigations and response efforts; effectiveness of containment and
control measures; and the status of an applicable determination of
public health emergency of international concern declared by the
Director General of the WHO.
(5) HHS/CDC will directly provide medical examiners information
pertaining to all applicable additional requirements for medical
screening and testing, and will post these at the following Internet
addresses: http://www.cdc.gov/ncidod/dq/technica.htm and http://www.globalhealth.gov.
(d) Risk-based approach. (1) HHS/CDC will use the medical and
epidemiological factors listed in paragraph (d)(2) of this section to
determine the following:
(i) Whether a disease as specified in Sec. 34.2(b)(3)(ii) is a
communicable disease of public health significance.
(ii) Which diseases in Sec. Sec. 34.2(b)(2) and (b)(3) merit
additional screening and testing, and the geographic area in which HHS/
CDC will require this screening.
(2) Medical and epidemiological factors include the following:
(i) The seriousness of the disease's public health impact;
(ii) Whether the emergence of the disease was unusual or
unexpected;
(iii) The risk of the spread of the disease in the United States;
(iv) The transmissibility and virulence of the disease;
(v) The impact of the disease at the geographic location of medical
screening; and
(vi) Other specific pathogenic factors that would bear on a
disease's ability to threaten the health security of the United States.
(e) Persons subject to requirement for chest X-ray examination and
serologic testing. (1) As provided in paragraph (e)(2) of this section,
a chest X-ray examination, and serologic testing for syphilis and
serologic testing for HIV shall be required as part of the examination
of the following:
(i) Applicants for immigrant visas;
(ii) Students, exchange visitors, and other applicants for non-
immigrant visas required by a U.S. consular authority to have a medical
examination;
(iii) Applicants outside the United States who apply for refugee
status;
(iv) Applicants in the United States who apply for adjustment of
their status under the immigration statute and regulations.
(2) Chest X-ray examination and serologic testing. Except as
provided in paragraph (e)(2)(iv) of this section, applicants described
in paragraph (e)(1) of this section shall be required to have the
following:
(i) For applicants 15 years of age and older, a chest x-ray
examination;
(ii) For applicants under 15 years of age, a chest x-ray
examination if the applicant has symptoms of tuberculosis, a history of
tuberculosis, or evidence of possible exposure to a transmissible
tuberculosis case in a household or other enclosed environment for a
prolonged period;
(iii) For applicants 15 years of age and older, serologic testing
for syphilis and HIV.
(iv) Exceptions. Serologic testing for syphilis and HIV shall not
be required if the alien is under the age of 15, unless there is a
reason to suspect infection with syphilis or HIV. HHS/CDC may authorize
exceptions to the requirement for a tuberculin skin test, an equivalent
test for showing an immune response to Mycobacterium tuberculosis
antigens, or chest X-ray examination for good cause, upon application
approved by the Director.
(3) Immune Response to Mycobacterium tuberculosis antigens. (i) All
aliens 2 years of age or older in the United States who apply for
adjustment of status to permanent residents, under the immigration laws
and regulations, or other aliens in the United States who are required
by the U.S. Department of Homeland Security to have a medical
examination in connection with a determination of their admissibility,
shall be required to have a tuberculin skin test or an equivalent test
for showing an immune response to Mycobacterium tuberculosis antigens.
Exceptions to this requirement may be authorized for good cause upon
application approved by the Director. In the event of a positive
tuberculin reaction, a chest X-ray examination shall be required. If
the chest radiograph is consistent with tuberculosis, the alien shall
be referred to the local health authority for evaluation. Evidence of
this evaluation shall be provided to the civil surgeon before a medical
notification may be issued.
(ii) Aliens less than 2 years old shall be required to have a
tuberculin skin test, or an equivalent, appropriate test to show an
immune response to Mycobacterium tuberculosis antigens, if there is
evidence of contact with a person known to have tuberculosis or other
reason to suspect tuberculosis. In the event of a positive tuberculin
reaction, a chest X-ray examination shall be required. If the chest
radiograph is consistent with tuberculosis, the alien shall be referred
to the local health authority for evaluation. Evidence of this
evaluation shall be provided to the civil surgeon before a medical
notification may be issued.
(iii) Aliens outside the United States required to have a medical
examination shall be required to have a tuberculin skin test, or an
equivalent, appropriate test to show an immune response to
Mycobacterium tuberculosis antigens, and, if indicated, a chest
radiograph.
(iv) Aliens outside the United States required to have a medical
examination shall be required to have a tuberculin skin test, or an
equivalent, appropriate test to show an immune response to
Mycobacterium tuberculosis antigens, and a chest radiograph, regardless
of age, if they have symptoms of tuberculosis, a history of
tuberculosis, or evidence of possible exposure to a transmissible
tuberculosis case in a household or other enclosed environment for a
prolonged period.
(4) Additional testing requirements. All applicants subject to the
chest radiograph requirement, and for whom the radiograph shows an
abnormality suggestive of tuberculosis disease, shall be required to
undergo additional testing for tuberculosis.
(5) How and where performed. All chest radiograph images used in
medical examinations performed under the regulations in this Part shall
be large enough to encompass the entire chest (approximately 14 by 17
inches; 35.6x43.2 cm.). Serologic testing for HIV shall be a sensitive
and specific test, confirmed when positive by a test such as the
Western blot test or an equally reliable test. For aliens examined
abroad, the serologic testing for HIV must be completed abroad, except
that the Secretary of Homeland Security after consultation with the
Secretary of State and the Secretary of Health and Human Services may
in emergency circumstances permit serologic testing of refugees for HIV
to be completed in the United States.
(6) Chest X-ray, laboratory, and treatment reports. The chest
radiograph reading and serologic test results for syphilis and HIV
shall be included in the medical notification. When the medical
examiner's conclusions are based on a study of more than one chest X-
ray image, the medical notification
[[Page 58058]]
shall include at least a summary statement of findings of the earlier
images, followed by a complete reading of the last image, and dates and
details of any laboratory tests and treatment for tuberculosis.
(f) Procedure for transmitting records. For aliens issued immigrant
visas, the medical notification and chest X-ray images, if any, shall
be placed in a separate envelope which shall be sealed. When more than
one chest X-ray image is used as a basis for the examiner's
conclusions, all images shall be included.
(g) Failure to present records. When a determination of
admissibility is to be made at the U.S. port of entry, a medical hold
document shall be issued pending completion of any necessary
examination procedures. A medical hold document may be issued for
aliens who:
(1) Are not in possession of a valid medical notification, if
required;
(2) Have a medical notification which is incomplete;
(3) Have a medical notification which is not written in English;
(4) Are suspected to have an excludable medical condition.
(h) The Secretary of Homeland Security, after consultation with the
Secretary of State and the Secretary of Health and Human Services, may
in emergency circumstances permit the medical examination of refugees
to be completed in the United States.
(i) All medical examinations shall be carried out in accordance
with such technical instructions for physicians conducting the medical
examination of aliens as may be issued by the Director. Copies of such
technical instructions are available upon request to the Director,
Division of Global Migration and Quarantine, Mailstop E03, HHS/CDC,
Atlanta GA 30333.
Dated: June 25, 2008.
Michael O. Leavitt,
Secretary, Department of Health and Human Services.
[FR Doc. E8-23485 Filed 10-3-08; 8:45 am]
BILLING CODE 4163-18-P