[DOCID: f:sr152.110]
From the Senate Reports Online via GPO Access
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Calendar No. 350
110th Congress Report
SENATE
1st Session 110-152
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GLOBAL PATHOGEN SURVEILLANCE ACT OF 2007
_______
September 11, 2007.--Ordered to be printed
Mr. Biden, from the Committee on Foreign Relations,
submitted the following
REPORT
[To accompany S. 1687]
The Committee on Foreign Relations, having had under
consideration a bill (S. 1687), to provide for global pathogen
surveillance and response, reports favorably thereon and
recommends that the bill do pass.
CONTENTS
Page
I. Purpose..........................................................1
II. Legislative History and Committee Action.........................2
III. Discussion.......................................................2
IV. Section-By-Section Analysis......................................5
V. Cost Estimate....................................................9
VI. Evaluation of Regulatory Impact.................................11
VII. Changes in Existing Law.........................................11
I. PURPOSE
This legislation is designed to enhance the capability of
the international community to detect, identify, and contain
infectious disease outbreaks, whether the cause of those
outbreaks is intentional or natural in origin. This bill
targets U.S. assistance to developing nations in the following
areas:
<bullet> Training of public health personnel in epidemiology,
including diagnosis and containment of likely
bioterrorism agents;
<bullet> Acquisition of laboratory and diagnostic equipment;
<bullet> Acquisition of communications technology to quickly
transmit data on disease patterns and pathogen
diagnoses to national public health authorities and to
international institutions such as the World Health
Organization (WHO);
<bullet> Expansion of overseas Centers for Disease Control
and Prevention (CDC) and Department of Defense
laboratories engaged in infectious disease research and
disease surveillance, through the establishment of
additional laboratories, enlargement of existing
facilities, increases in the number of personnel, and/
or expanding the scope of their activities; and
<bullet> Expanded assistance to the WHO and regional
international disease surveillance efforts, including
expansion of U.S.-administered Field Epidemiology
Training Programs.
II. LEGISLATIVE HISTORY AND COMMITTEE ACTION
S. 1687 was introduced by Senator Biden on June 25, 2007.
It is cosponsored by Senators Hagel, Kennedy and Casey. On June
27, 2007, the committee ordered the bill reported favorably by
voice vote.
III. DISCUSSION
In January 2000, the National Intelligence Council released
a National Intelligence Estimate entitled, The Global
Infectious Disease Threat and Its Implications for the United
States. The key judgments in that report were sobering:
New and reemerging infectious diseases will pose a rising
global health threat and will complicate US and global security
over the next 20 years. These diseases will endanger US
citizens at home and abroad, threaten US armed forces deployed
overseas, and exacerbate social and political instability in
key countries and regions in which the United States has
significant interests.\1\
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\1\National Intelligence Council, ``The Global Infectious Disease
Threat and Its Implications for the United States,'' National
Intelligence Estimate NIE 99-17D (January 2000), p. 5.
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Development of an effective global surveillance and response
system probably is at least a decade or more away, owing to
inadequate coordination and funding at the international level
and lack of capacity, funds, and commitment in many developing
and former communist states.\2\
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\2\Ibid., p. 8.
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The probability of a bioterrorist attack against US civilian
and military personnel overseas or in the United States also is
likely to grow as more states and groups develop a biological
warfare capability. Although there is no evidence that the
recent West Nile virus outbreak in New York City was caused by
foreign state or nonstate actors, the scare and several earlier
instances of suspected bioterrorism showed the confusion and
fear they can sow regardless of whether or not they are
validated.\3\
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\3\Ibid., p. 11.
The Estimate went on to elaborate regarding the challenges
to maintaining an effective world-wide disease surveillance
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system:
A major obstacle to effective global surveillance and control
of infectious diseases will continue to be poor or inaccurate
national health statistical reporting by many developing
countries and lack of both capacity and will to properly direct
aid ... and to follow WHO and other recommended health care
practices. Those areas of the world most susceptible to
infectious disease problems are least able to develop and
maintain the sophisticated and costly communications equipment
needed for effective disease surveillance and reporting. In
addition to the barriers dictated by low levels of development,
revealing an outbreak of a dreaded disease may harm national
prestige, commerce, and tourism.\4\
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\4\Ibid., p. 34.
In January 2001, the National Intelligence Council released
another National Intelligence Estimate, entitled, The
Biological Warfare Threat. The report pointed to the growing
biological warfare capabilities of state and nonstate actors
and, more importantly, highlighted the similar patterns and
symptoms of a deliberately initiated disease outbreak and a
naturally occurring outbreak. Once an outbreak is detected and
begins to spread, it is very difficult to distinguish between a
deliberate and a natural disease outbreak. Both are potentially
devastating to human, animal, and plant life, moreover, as well
as economically costly. Epidemiologists and public health
experts rely on similar tools to help prevent, detect, and
contain both intentional and naturally occurring disease
outbreaks.
According to an August 2001 report by the U.S. General
Accounting Office (GAO, now known as the U.S. Government
Accountability Office), WHO officials said that more than 60
percent of laboratory equipment in developing countries was
either outdated or non-functioning, and that the vast majority
of national personnel were not familiar with quality assurance
principles for handling and analyzing biological samples.
Deficiencies in training and equipment meant that many public
health units in Africa and Asia were simply unable to perform
accurate and timely disease surveillance.\5\
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\5\United States General Accounting Office, ``Global Health:
Challenges in Improving Infectious Disease Surveillance Systems,'' GAO-
01-722 (August 2001), p.3.
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On September 5, 2001, the Senate Foreign Relations
Committee held a hearing regarding the threat of bioterrorism
and the spread of infectious diseases. Witnesses included
former Senator Sam Nunn, Dr. Donald A. Henderson of Johns
Hopkins University (later a scientific advisor to the White
House and the Department of Health and Human Services), and Dr.
David L. Heymann, then Executive Director for Communicable
Diseases at the WHO. After the appearance, later in September
2001, of letters containing anthrax spores, which left 5 dead
and caused major disruptions in the U.S. Senate and elsewhere,
the committee held a March 19, 2002, hearing on the chemical
and biological weapons threat. At that hearing, Dr. Alan P.
Zelicoff, Senior Scientist at Sandia National Laboratories,
testified on the role of syndromic surveillance in bioterrorism
prevention.
The committee believes that the threat of bioterrorism
poses significant challenges not only for the United States,
but for the entire world. It is difficult to protect our
nation's health without international cooperation in an age of
unprecedented air travel and international trade, as infectious
pathogens are transported across borders each day. The global
outbreak of severe acute respiratory syndrome, or SARS, was an
unfortunate reminder of this vulnerability. More recently, a
man thought at the time to have extensively drug-resistant
tuberculosis flew across an ocean--twice--and drove across
several national borders, reminding us how readily a disease
can be spread in the modern world. Fortunately, although
extensively drug-resistant TB is especially difficult to treat,
it does not spread as readily as influenza or some other
diseases. Authorities knew who the disease vector was,
moreover, and they knew (more or less) what he had. The risk
with H5N1 avian influenza or a bioterrorism attack is
heightened by the likelihood that the disease will spread
before its presence is even evident.
Infectious disease outbreaks are transnational threats and
the defense of our homeland is not an isolated activity. Rather
it requires a comprehensive strategy, including a critical
international component. Whether intentional or natural,
infectious diseases do not recognize the boundaries set by
national borders.
Developing nations represent one of the weak links in a
comprehensive global surveillance and monitoring network. For
example, even though the world has made substantial efforts to
combat and prepare for the possibility of a global avian
influenza pandemic, a recent GAO report suggests that the
surveillance capabilities of many countries--even when focused
on a single disease--remain dangerously inadequate. The report
cites a senior WHO official as saying that numerous ``disease
blind spots'' around the world hamper the organization's
ability to identify H5N1 outbreaks. It goes on to say that
studies conducted in 2006 by the UN System Influenza
Coordinator, in collaboration with the World Bank, found that
about one-third of the countries surveyed lacked the capacity
to diagnose avian influenza in humans.\6\ Unfortunately,
naturally occurring disease outbreaks are most likely to occur
in these areas where poor sanitary conditions, poverty, and a
weak medical infrastructure combine to offer ideal breeding
grounds for pathogens. In addition, some developing countries
border rogue states or states that offer sanctuaries for
international terrorist groups, which have a documented
interest in biological agents.
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\6\United States Government Accountability Office, ``Influenza
Pandemic: Efforts to Forestall Onset Are Under Way: Indentifying
Countries at Greatest Risk Entails Challenges,'' GAO-07-604 (June
2007), pp. 16n and 18-19.
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In 2005, two sets of researchers reported in the journals
Nature and Science that, based on computer simulations, if an
outbreak of human-to-human-transmitted avian flu were to occur
in a rural part of Southeast Asia, it might be possible to stem
that dangerous epidemic by using anti-viral drugs to treat the
tens of thousands of people who might have been exposed in the
initial outbreak. One key requirement, however, was that the
outbreak would have to be discovered, identified and reported
very quickly; in one study, the assumption was that
countermeasures were instituted when only 30 people had
observable symptoms.\7\ These simulations underscore both the
challenge of disease surveillance and the potential benefits if
effective and timely surveillance can be made available where
it is most needed.
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\7\Neil M. Ferguson, Derek A.T. Cummings, Simon Cauchemez,
Christophe Fraser, Steven Riley, Aronrag Meeyai, Sopon Iamsirithaworn
and Donald S. Burke, ``Strategies for containing an emerging influenza
pandemic in Southeast Asia,'' Nature, August 3, 2005. See also I.M.
Longini Jr., A. Nizam, S. Xu, K. Ungchusak, W. Hanshaoworakul, D.A.
Cummings, and M.E. Halloran, ``Containing pandemic influenza at the
source,'' Science, August 3, 2005.
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So it is vital to give these countries the capability to
track epidemics and to feed that information into international
surveillance networks. Disease surveillance is a systematic
approach that requires trained public health personnel, proper
diagnostic equipment to identify viruses and pathogens, and
prompt transmission of data from the doctor or clinic level all
the way to national governments and the WHO.
The Global Pathogen Surveillance Act will offer such help
to those countries that agree to give the United States and the
WHO prompt access to disease outbreaks, so that we can help
determine their origin. Recipients of this training will also
be able to learn to spot diseases that might be used in a
bioterrorist attack.
The Global Pathogen Surveillance Act was first introduced
in 2002. The Senate Foreign Relations Committee reported this
bill, either separately or as a title of a larger bill, on
several occasions since 2002, and the Senate passed the bill in
2002 and 2005. The original bill was drafted in consultation
with the WHO, the CDC, the Department of Defense and others,
and later versions benefited from suggestions from the State
Department and, in 2005, from staff of the Senate Health,
Education, Labor, and Pensions Committee.
The primary authority for implementation of the bill's
provisions is vested in the Department of State. The committee
expects that the Department of Health and Human Services will
also play a critical role, however, including being consulted
to the greatest extent possible.
Two years ago the Secretary of State, Dr. Condoleezza Rice,
expressed her strong backing for this legislation in an answer
for the record:
We believe that the Global Pathogen Surveillance Act will
indeed help strengthen developing countries' abilities to
identify and track pathogens that could be indicators of
dangerous disease outbreaks--either naturally-occurring or
deliberately released. Improved disease surveillance and
communication among nations are critical defenses against both
bioterrorism and natural outbreaks. We look forward to working
with you in support of the Global Pathogen Surveillance Act.
...
One of the true ``nightmare'' scenarios--of a bioterrorist
attack or a naturally occurring disease--involves a contagious
biological agent moving swiftly through a crowded urban area of
a densely populated developing nation. Thus, we believe that it
is critical to increase efforts to strengthen the public health
and scientific infrastructure necessary to identify and quickly
respond to infectious disease outbreaks--and that the Global
Pathogen Surveillance Act will provide valuable support in
these efforts.\8\
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\8\``The Nomination of Dr. Condoleezza Rice to be Secretary of
State,'' Hearings before the Committee on Foreign Relations, U.S.
Senate, January 18 and 19, 2005, S. Hrg. 109- 151, pp. 253- 254.
The WHO also shares the committee's concern. During the
SARS epidemic, Dr. Michael Heymann, who was the highest-ranking
American in the WHO, stated at a press conference: ``it is
clear that the best defense against the spread of emerging
infections such as SARS is strong national public health--
national disease detection and response capacities that can
identify new diseases and contain them before they spread
internationally.'' He went on to highlight the important role
that disease surveillance plays in combating both natural and
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terrorist outbreaks:
Global partnerships to combat global microbial threats make
good sense as a defense strategy that brings immediate benefits
in terms of strengthened pubic health and surveillance systems.
The resulting infectious disease intelligence brings dual
benefits in terms of protecting populations against both
naturally occurring and potentially deliberately caused
outbreaks. As SARS has so vividly demonstrated, the need is
urgent and of critical importance to the health of economies as
well as populations.
Support to developing countries such as proposed in the
Global Pathogen Surveillance Act ... will help strengthen
capacity of public health professionals and epidemiologists,
laboratory and other disease detection systems, and outbreak
response mechanisms for naturally occurring infectious diseases
such as SARS. This in turn will strengthen WHO and the world's
safety net for outbreak detection and response, of which the
United States is a major partner. And finally, strengthening
this global safety net to detect and contain naturally
occurring infectious diseases will strengthen the world's
capacity to detect and respond to infectious diseases that may
be deliberately caused.
IV. SECTION-BY-SECTION ANALYSIS
Section 1. Short Title
This Act is called the ``Global Pathogen Surveillance Act
of 2007.''
Section 2. Findings; Purpose
This section lays out the findings and purposes of this
Act.
Section 3. Definitions
This section defines five terms of art and sets forth one
routine definition. The definition of ``International Health
Organization'' in definition (3) is meant to be illustrative,
rather than exclusive; additional organizations to those cited
in the definition may also qualify as international health
organizations under the Act.
Section 4. Eligibility for Assistance
Section 4 requires, in general, that assistance under the
provisions of this Act be given only to those eligible
developing countries that permit personnel from the World
Health Organization (WHO) and the Centers for Disease Control
and Prevention (CDC) to investigate infectious disease
outbreaks on their territory and that provide pathogen
surveillance data derived from such assistance to appropriate
U.S. departments and agencies in addition to international
health organizations. The committee intends that this
requirement be met in a manner that does not reveal any
classified information to persons not authorized to receive
such information. Subsection (b) authorizes the Secretary of
State to waive the limitation in subsection (a) if the
Secretary determines that it is in the national interest of the
United States to provide such a waiver.
Section 5. Restriction
Section 5 restricts access by foreign nationals
participating in programs authorized under this title to select
agents that may be used as, or in, a biological weapon, except
in a supervised and controlled setting. The committee does not
believe that such a restriction will constrain foreign
nationals from fully participating in various training and
educational programs under this Act. Subsection (b) makes clear
that this restriction may not be construed to limit the ability
of the Secretary of Health and Human Services to prescribe,
through regulation, standards for the handling of a select
agent or toxin or an overlap select agent or toxin.
Section 6. Fellowship Program
Section 6 authorizes the Secretary of State to award
fellowships to eligible nationals of eligible developing
countries to pursue a master of public health degree or
advanced public health training in epidemiology within the
United States. Each fellow may also take courses of study at
the CDC or at an equivalent facility on diagnosis and
containment of likely bioterrorism agents. The committee
believes that carefully chosen programs of this sort should be
encouraged as they not only impart technical skills utilizing
state-of-the-art technology, but also help cultivate the
management and organizational skills of future leaders for
developing country public health programs.
Subsection (c) requires that fellows enter into an
agreement with the Secretary of State under which the fellow
will maintain satisfactory academic performance and, upon
completing the education or training, will return to his or her
country of nationality or last habitual residence (so long as
it is an eligible developing country) and complete at least
four years of employment in a public health position in the
government or a non-governmental, not-for-profit entity in that
country. Alternatively, with the Secretary's consent, the
fellow can complete part or all of this four-year requirement
with an international health organization. If the fellow is
unable to meet these requirements, he or she will be required
to reimburse the U.S. government for the value of the
assistance provided; the Secretary may waive the limitation in
this subsection if the Secretary determines that it is in the
national interest of the United States to provide such a
waiver.
Subsection (d) authorizes the Secretary of State, in
consultation with the Secretary of Health and Human Services,
to enter into an agreement with any eligible developing country
to establish the procedures for implementing the program.
Subsection (e) allows for the participation of U.S.
citizens on a case-by-case basis, if the Secretary of State
determines that it is in the national interest of the United
States to provide for such participation. Such participants
would be required, upon completion of education or training, to
complete at least five years of employment in a public health
position in an eligible developing country or at an
international health organization.
Subsection (f) allows the Secretary, with the concurrence
of the Secretary of Health and Human Services (HHS), to use
existing HHS programs to provide the education and training
described in this section, if the requirements of subsections
(b), (c) and (d) will be substantially met under such existing
programs.
Section 7. In-Country Training in Laboratory Techniques and Disease and
Syndrome Surveillance
Section 7 authorizes the provision of short-term training
courses outside the United States for laboratory technicians
and public health officials in laboratory techniques relating
to the identification, diagnosis, and tracking of pathogens
responsible for infectious disease outbreaks. This training may
take place in overseas facilities of the CDC or the Overseas
Medical Research Units of the Department of Defense, as
appropriate. Any such training shall be coordinated with
existing programs and activities of international health
organizations. Such training courses offer the opportunity for
public health personnel to train in their indigenous
environment, utilizing the available technology.
Subsection (b) authorizes short training courses, which
shall be conducted either via the Internet or in appropriate
facilities located in a foreign country, on disease and
syndrome surveillance techniques. Using disease and syndrome
surveillance, the emergence of a disease in a population is
monitored based on geographic patterns of clinician-reported
patient complaints and signs derived from physical examination
and laboratory data.
Section 8. Assistance for the Purchase and Maintenance of Public Health
Laboratory Equipment and Supplies
Section 8 authorizes the President to furnish assistance to
eligible developing countries to purchase and maintain public
health laboratory equipment and supplies that are needed to
collect, analyze, and identify expeditiously a broad array of
pathogens, including mutant strains, which may cause disease
outbreaks or be used in a biological weapon. The equipment and
supplies are to be appropriate for use in the intended
geographic area and compatible with general standards set forth
by the WHO and, as appropriate, the CDC. They must not be
defense articles or articles that would be subject to the Arms
Export Control Act or likely be barred or subject to special
conditions under the Export Administration Act of 1979 if
purchased in the United States. This section does not exempt
the exporting of goods or technology from compliance with
applicable provisions of the Export Administration Act of 1979
(as in effect pursuant to the International Emergency Economic
Powers Act, 50 U.S.C. 1701 et seq.).
Subsection (e) provides that preference should be given to
the purchase of equipment and supplies of U.S. manufacture.
Subsection (f) requires that the eligible developing country
agree to properly house, maintain, support, secure, and
maximize the use of equipment and supplies provided under this
section.
Section 9. Assistance for Improved Communication of Public Health
Information
Section 9 authorizes the President to provide assistance to
eligible developing countries to purchase and maintain
communications equipment and information technology to
effectively and quickly collect, analyze, and transmit public
health information within and among developing countries and to
and from international health organizations. The requirements
and limitations applied to assistance in section 8 are also
applied to section 9. In addition, subsection (f) authorizes
the President to provide assistance to international health
organizations to facilitate standardization in the reporting of
public health information.
Section 10. Assignment of Public Health Personnel to United States
Missions and International Organizations
Section 10 authorizes the heads of Executive branch
departments and agencies to assign public health personnel to
U.S. diplomatic missions and international health organizations
when requested, with the concurrence of the Secretary of State
and of the employee concerned, for the purpose of enhancing
disease and pathogen surveillance efforts in developing
countries. The Department of State is authorized, under certain
circumstances, to reimburse an agency or department for the
costs incurred by reason of the detail of such personnel.
Section 11. Expansion of Certain United States Government Laboratories
Abroad
Section 11 mandates the expansion of the overseas
laboratories and other related facilities of the CDC and the
Department of Defense, subject to the availability of
appropriations. This expansion applies to both numbers of
personnel and the scope of operations. The intent of this
provision is to further the goals of global pathogen
surveillance and monitoring. Overseas CDC and Department of
Defense facilities, working with host governments, play a
crucial role in enhancing the capability of developing
countries to monitor disease outbreaks and possible biological
weapons attacks. The committee intends that the expansion of
CDC and Department of Defense overseas laboratory activities be
undertaken in close cooperation with host countries, to benefit
their well-being and national security as well as that of the
United States.
Subsection (b) provides that the expansion be carried out
in such a manner as to foster cooperation and avoid duplication
between and among laboratories. Subsection (c) provides that
the expansion may not detract from the established core
missions of the laboratories or compromise the security of
those laboratories.
Section 12. Assistance for International Health Networks and Expansion
of Field Epidemiology Training Programs
Section 12 authorizes the President to provide assistance
for the purposes of enhancing the surveillance and reporting
capabilities of the WHO and existing international regional and
international health networks and for developing new
international regional and international health networks, as a
means of continuing to expand the reach of a global
surveillance network.
Subsection (b) authorizes the Secretary of Health and Human
Services to establish new country or regional international
Field Epidemiology Training Programs in eligible developing
countries. These programs offer two years of intense training
for health professionals in entry- or mid-level positions to
help build up indigenous capacity in epidemiology and public
health.
Section 13. Reports
Section 13 requires the Secretary of State to submit a
report to the Senate Foreign Relations Committee and the House
Foreign Affairs Committee, not later than 90 days after the
date of enactment of this Act, on the implementation of
programs under this Act, including an estimate of the level of
funding required to carry out such programs at a sufficient
level.
Section 14. Authorization of Appropriations
This section authorizes appropriations for carrying out
provisions of this title for Fiscal Years 2008 and 2009. The
section authorizes $115 million in total. Of this amount, $40
million is authorized for Fiscal Year 2008 and $75 million for
Fiscal Year 2009. Subsection (b) provides that the amounts
appropriated pursuant to subsection (a) are authorized to
remain available until expended. Subsection (c) provides that
not more than 10 percent of the amount appropriated for Fiscal
Year 2008 may be obligated before the date on which a report is
submitted, or required to be submitted, whichever first occurs,
under section 13.
V. COST ESTIMATE
In accordance with Rule XXVI, paragraph 11(a) of the
Standing Rules of the Senate, the committee provides this
estimate of the costs of this legislation prepared by the
Congressional Budget Office.
United States Congress,
Congressional Budget Office,
Washington, DC, July 20, 2007.
Hon. Joseph R. Biden, Jr.,
Chairman, Committee on Foreign Relations,
U.S. Senate, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 1687, the Global
Pathogen Surveillance Act of 2007.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Sam
Papenfuss.
Sincerely,
Peter R. Orszag.
------
Congressional Budget Office Cost Estimate
July 20, 2007.
S. 1687
Global Pathogen Surveillance Act of 2007
AS ORDERED REPORTED BY THE SENATE COMMITTEE ON FOREIGN RELATIONS ON
JUNE 27, 2007
S. 1687 would authorize the appropriation of $40 million in
2008 and $75 million in 2009 for the following activities:
<bullet> Establish a fellowship program that would allow
certain foreign nationals to pursue public health
education or training in the United States;
<bullet> Expand operations at laboratories of the Department
of Defense and the Centers for Disease Control and
Prevention that are located in developing countries,
and provide assistance to local individuals for
training in laboratory techniques related to infectious
diseases;
<bullet> Provide assistance to developing countries to
purchase and maintain public health laboratory
equipment and supplies and to purchase communications
equipment and technology to effectively collect,
analyze, and transmit public health information; and
<bullet> Provide assistance to the World Health Organization
and establish new training programs in field
epidemiology.
Based on historical spending patterns for similar
activities, CBO estimates that implementing S. 1687 would cost
$8 million in 2008 and $108 million over the 2008-2012 period,
assuming appropriation of the authorized amounts. Enacting the
bill would not affect direct spending or receipts.
S. 1687 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act and
would not affect the budgets of state, local, or tribal
governments.
The CBO staff contact for this estimate is Sam Papenfuss.
This estimate was approved by Peter H. Fontaine, Deputy
Assistant Director for Budget Analysis.
VI. EVALUATION OF REGULATORY IMPACT
Pursuant to Rule XXVI, paragraph 11(b) of the Standing
Rules of the Senate, the committee has determined that there is
no regulatory impact as a result of this legislation.
VII. CHANGES IN EXISTING LAW
In compliance with paragraph 12 of Rule XXVI of the
Standing Rules of the Senate, the committee notes that no
changes to existing law are made by this bill.