[Senate Report 111-377]
[From the U.S. Government Publishing Office]
111th Congress
2d Session SENATE Report
111-377
_______________________________________________________________________
Calendar No. 705
WMD PREVENTION AND PREPAREDNESS ACT OF 2009
__________
R E P O R T
of the
COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
to accompany
S. 1649
together with
MINORITY VIEWS
TO PREVENT THE PROLIFERATION OF WEAPONS OF MASS DESTRUCTION, TO PREPARE
FOR ATTACKS USING WEAPONS OF MASS DESTRUCTION, AND FOR OTHER PURPOSES
December 17, 2010.--Ordered to be printed
COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
JOSEPH I. LIEBERMAN, Connecticut, Chairman
CARL LEVIN, Michigan SUSAN M. COLLINS, Maine
DANIEL K. AKAKA, Hawaii TOM COBURN, Oklahoma
THOMAS R. CARPER, Delaware SCOTT P. BROWN, Massachusetts
MARK L. PRYOR, Arkansas JOHN McCAIN, Arizona
MARY L. LANDRIEU, Louisiana GEORGE V. VOINOVICH, Ohio
CLAIRE McCASKILL, Missouri JOHN ENSIGN, Nevada
JON TESTER, Montana LINDSEY GRAHAM, South Carolina
CHRISTOPHER A. COONS, Delaware MARK KIRK, Illinois
Michael L. Alexander, Staff Director
Kevin J. Landy, Chief Counsel
Gordon N. Lederman, Counsel
Aaron M. Firoved, Professional Staff Member
Brandon L. Milhorn, Minority Staff Director and Chief Counsel
Robert L. Strayer, Minority Director for Homeland Security Affairs
Asha A. Mathew, Minority Senior Counsel
Trina Driessnack Tyrer, Chief Clerk
Calendar No. 705
111th Congress Report
SENATE
2d Session 111-377
======================================================================
WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS ACT OF 2009
_______
December 17, 2010.--Ordered to be printed
_______
Mr. Lieberman, from the Committee on Homeland Security and Governmental
Affairs, submitted the following
R E P O R T
together with
MINORITY VIEWS
[To accompany S. 1649]
The Committee on Homeland Security and Governmental
Affairs, to which was referred the bill (S. 1649) to prevent
the proliferation of weapons of mass destruction, to prepare
for attacks using weapons of mass destruction, and for other
purposes, having considered the same, reports favorably thereon
with an amendment and recommends that the bill, as amended, do
pass.
CONTENTS
Page
I. Purpose and Summary..............................................1
II. Background and Need for the Legislation..........................2
III. Legislative History.............................................29
IV. Section-by-Section Analysis.....................................31
V. Evaluation of Regulatory Impact.................................53
VI. Congressional Budget Office Cost Estimate.......................54
VII. Changes in Existing Law Made by the Bill, as Reported...........59
VIII.Minority Views..................................................88
I. Purpose and Summary of the Legislation
The purpose of the Weapons of Mass Destruction (WMD)
Prevention and Preparedness Act of 2010 is to provide a
comprehensive framework for the United States to prevent and
prepare for biological and other WMD attacks. Key provisions of
the Act include heightening U.S. and international laboratory
security regarding the most dangerous pathogens, strengthening
intelligence and bioforensics, improving the information
provided to citizens, enhancing emergency responders' safety,
and distributing countermeasures to victims.
II. Background and Need for the Legislation
A. GENERAL NATURE OF THE WMD THREAT
A weapon of mass destruction can assume many forms. It can
be a nuclear bomb that with a blinding flash can kill countless
people and level buildings for miles around. It can be a
biological pathogen released undetectably and spread quietly
among the population until suddenly the disease emerges and
overwhelms our hospitals' capacities to care for the sick. Or,
it can be a chemical agent released in the close confines of a
subway, striking down commuters in an instant. But whatever
form a WMD takes, it can bring exactly what its name suggests--
mass destruction--to our people, our infrastructure, and our
economy.
Unfortunately, the threat of terrorists attacking us using
WMDs is a real and near-term danger--in terms of both the
potential for terrorists to acquire and use such weapons and
the horrific consequences of an attack. In December 2008, then-
Director of National Intelligence (DNI), Mike McConnell, warned
publicly that a WMD terrorist attack is more likely than not to
occur somewhere in the world by 2013 and that a biological
attack is more likely than a nuclear attack.\1\ The bipartisan
Commission for the Prevention of Weapons of Mass Destruction
Proliferation and Terrorism (``Prevent WMD Commission''), co-
chaired by former Senators Bob Graham and Jim Talent, seconded
DNI McConnell's warning concerning biological weapons in its
December 2008 report, World at Risk.\2\ The Prevent WMD
Commission's report assessed the overall threat of WMD posed by
terrorists to the United States and offered recommendations to
close identified gaps in the nation's preparedness efforts.
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\1\See Remarks and Q&A by the Director of National Intelligence,
Mike McConnell, at the John F. Kennedy, Jr. Forum at Harvard
University, December 2, 2008, available at http://www.odni.gov/
speeches/20081202_speech.pdf (last accessed October 8, 2010), at 8.
\2\The Prevent WMD Commission was created by the Implementing
Recommendations of the 9/11 Commission Act of 2007 (P.L. 110-53). World
at Risk: The Report of the Commission on the Prevention of Weapons of
Mass Destruction Proliferation and Terrorism. December 2008, available
at http://www.preventwmd.gov/report/ (last accessed October 8, 2010),
at xv.
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A WMD terrorist attack is one of the most serious national
security challenges faced by the United States. As President
Barack Obama stated on the eve of an April 2010, Nuclear
Security Summit, ``we know that organizations like al Qaeda are
in the process of trying to secure a nuclear weapon--a weapon
of mass destruction that they have no compunction at
using.''\3\ And as the President previously has said, ``If an
organization like al Qaeda got a weapon of mass destruction on
its hands--a nuclear or a chemical or a biological weapon--and
they used it in a city, whether it's in Shanghai or New York,
just a few individuals could potentially kill tens of thousands
of people, maybe hundreds of thousands.''\4\ Similarly,
President Obama's Assistant to the President for National
Security Affairs, General James Jones, USMC (ret.), stated
publicly on October 4, 2009, that the most alarming threat
facing the United States is the nexus of WMD proliferation and
terrorism:
\3\CNN, ``Political Punch,'' April 11, 2010, available at http://
blogs.abcnews.com/politicalpunch/2010/04/president-obama-al-qaeda-is-
seeking-a-nuke-to-kill-innocents.html (last accessed April 12, 2010).
\4\Quoted in Rolf Mowatt-Larssen, Al Qaeda Weapons of Mass
Destruction Threat: Hype or Reality?, Belfer Center for Science and
International Affairs, Harvard Kennedy School (2010), at 3.
There are a lot of things that keep me up at night,
but if I had to pick one that I--that I thought was
most--most alarming, it's the question of proliferation
and weapons of mass destruction falling into
terrorists' hands. Generally, nation states, once they
have the capability, can be controlled a little bit
more. But if we--if we lost, you know, track of nuclear
weapons or other weapons of mass destruction and [they]
came into the hands of a radical terrorist group, they
would use them. And that--and that bothers me a great
deal. And that's why this question of proliferation is
probably central to how our children and grandchildren
are going to live in this 21st century.\5\
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\5\CNN, ``State of the Union,'' October 4, 2009, available at
http://transcripts.cnn.com/TRANSCRIPTS/0910/04/sotu.05.html (last
accessed December 10, 2010).
WMDs are of particular interest to terrorist groups. As far
back as 1998, Osama bin Laden called acquiring WMDs for the
defense of Muslims a religious duty.\6\ Islamist extremist
religious leaders associated with al Qaeda have issued
religious decrees, or fatwas, justifying mass murder and the
use of WMD against their enemies.\7\ Al Qaeda's spokesman,
Sulayman Abu Gayth al Libi, stated that al Qaeda would be
justified in using WMDs to kill four million Americans.\8\
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\6\Rahimullah Yusufzai, ``Conversations with Terror,'' TIME,
January 11, 1999.
\7\``A Treatise on the Legal Status of Using Weapons of Mass
Destruction Against Infidels,'' issued by radical cleric Nasir Bin Hamd
al-Fahd in May 2003, available at http://www.jihadspin.com/
NeclearFatwa.pdf (last accessed April 12, 2010).
\8\Al Qaeda Weapons of Mass Destruction Threat: Hype or Reality?,
at 23.
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Although the term WMD has no universally agreed-upon
definition, the term is used generally in U.S. statutes and
government documents to refer to nuclear, chemical, and
biological weapons.\9\ Similarly, a report by the Department of
Defense entitled Proliferation Threat and Response 2001 refers
to ``capabilities to inflict mass casualties and destruction:
nuclear, biological and chemical (NBC) weapons or the means to
deliver them.''\10\
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\9\See ``WMD 411: Definitions of WMD,'' Nuclear Threat Initiative,
available at http://www.nti.org/f_wmd411/f1a1.html (last accessed April
8, 2010).
\10\Department of Defense, Proliferation Threat and Response 2001
(2001), available at http://www.fas.org/irp/threat/prolif00.pdf, at i.
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To be sure, conventional weapons also can inflict mass
casualties and destruction--example, nuclear weapons can be
more than one million times more powerful than the same.
However, WMD are distinguished by their destructive force as
compared to their small size. For weight of conventional
explosives and also generate long-term radioactive fall-out as
well as damage electronic instruments by producing an
electromagnetic pulse.\11\ A single nuclear weapon dropped on
Hiroshima in 1945 killed approximately 68,000 people and
injured another 76,000.\12\ Producing a nuclear weapon requires
access to uranium or plutonium, which the international
community has attempted to control tightly. Chemical weapons
have a long history of use in warfare and more recently have
been employed by terrorists. For example, the Aum Shinrikyo
cult killed 12 people in a sarin gas attack on the Tokyo subway
system in 1995. Chemical weapons can be manufactured from a
variety of substances that are used commercially, such as
chlorine.
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\11\U.S. Congress, Office of Technology Assessment, Proliferation
of Weapons of Mass Destruction: Assessing the Risks, OTA-ISC-559 (U.S.
Government Printing Office, 1993), available at http://www.au.af.mil/
au/awc/awcgate/ota/9341.pdf (last accessed October 20, 2010), at 2-3
and n.1.
\12\Id. at 46.
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The bioterrorism threat specifically
Bacteria and viruses are used widely in the research and
commercial sectors for purposes such as disease studies, drug
delivery, sanitation or manufacturing. Some organisms that
cause human or agricultural diseases, or pathogens, are also
suitable for development into biological weapons because they
contain the right characteristics of lethality, deliverability,
and stability. In the wrong hands, a surprisingly small volume
of such a biological weapon can cause a surprisingly large
number of human casualties either directly or by ``growing''
the material to create additional weapons. In the ``National
Strategy for Countering Biological Threats,'' released by
President Obama on November 23, 2009, the National Security
Council stated:
The effective dissemination of a lethal biological
agent within an unprotected population could place at
risk the lives of hundreds of thousands of people. The
unmitigated consequences of such an event could
overwhelm our public health capabilities, potentially
causing an untold number of deaths. The economic cost
could exceed one trillion dollars for each such
incident. In addition, there could be significant
societal and political consequences that would derive
from the incident's direct impact on our way of life
and the public's trust in government.\13\
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\13\National Strategy for Countering Biological Threats, National
Security Council, November 2009, Available at http://
www.whitehouse.gov/sites/default/files/National_Strategy_
for_Countering_BioThreats.pdf (last accessed October 15, 2010), at 1.
In 2001, trace amounts of anthrax sent through the U.S.
mail system sickened twenty-two people, killing five of them.
According to the President's Homeland Security Council, a
single airborne attack using anthrax in one city with one truck
could yield nearly 330,000 exposures and cause 13,000
fatalities.\14\ Ultimately, a biological weapon can produce as
many fatalities as a nuclear weapon.\15\ Congress's Office of
Technology Assessment estimated that an airplane dispersing one
hundred kilograms of anthrax over a city could kill between
420,000 and 1.4 million people.\16\
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\14\World at Risk, at 5-6.
\15\Nuclear Threat Initiative, ``Effects of WMD,'' updated August
2010, available at http://www.nti.org/f_wmd411/f1a2.html (last accessed
April 12, 2010).
\16\Proliferation of Weapons of Mass Destruction: Assessing the
Risks, at 54.
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The development of nuclear weapons requires advanced
equipment, a high and relatively scarce level of expertise, and
access to tightly controlled materials. Biological weapons, in
contrast, can be created by many members of the large global
biological sciences workforce, using technology that is widely
available for legitimate purposes and pathogens stored at
institutions with varying levels of security or directly from
natural environmental sources. All of these factors make
biological weapons considerably easier and cheaper to produce
in facilities that are smaller and harder to detect than those
required to create a nuclear device. Indeed, then-speaker of
the Iranian Parliament, Hashemi Rafsanjani, stated in 1988 that
biological and chemical weapons are ``the poor man's atomic
bomb.''\17\ Biological weapons using infectious pathogens such
as smallpox can quickly spread beyond the point of release to
other areas, putting an entire nation or region at risk without
requiring multiple terrorists to attack in different areas. For
biological weapons using pathogens that do not spread person to
person readily, such as anthrax, the ability to easily
replicate the pathogen in the laboratory means that little
stands in the way of producing multiple or ever larger weapons.
As with the 2001 anthrax attacks, bioterrorists would likely
conduct a campaign of attacks because it is easy to field
multiple weapons once the first one has been developed.
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\17\North Atlantic Assembly, Chemical and Biological Weapons: The
Poor Man's Bomb, Draft General Report (1996), available at http://
ftp.fas.org/irp/threat/an253stc.htm, (last accessed April 12, 2010).
The North Atlantic Assembly report noted, ``This phrase is as accurate
as it is alarming. While nuclear weapons represent the zenith of mass
destruction, their fabrication requires advanced industrial
capabilities as well as access to rare, tightly controlled materials.
Chemical and biological weapons, on the other hand, are cheap and easy
to build using equipment and materials that are used extensively for a
host of civilian purposes.'' Id.
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Al Qaeda's interest in developing biological weapons is
well documented.\18\ The National Security Council confirmed in
the Administration's ``National Strategy for Countering
Biological Threats'' that ``in 2001, while engaging the Taliban
in Afghanistan, coalition forces came into possession of a
significant body of evidence that al-Qa'ida was seeking to
develop the capability to conduct biological weapons
attacks.''\19\ And as the Secretary of Homeland Security, Janet
Napolitano, has stated, biological and chemical weapons ``are
capacities al Qaeda has sought for years.''\20\ In the late
1990's, al Qaeda established a biological weapons program and a
biological laboratory in Kandahar, Afghanistan, which included
experiments on animals.\21\ Among its members, al Qaeda had
several individuals with advanced scientific expertise,
including in the fields of chemistry and microbiology.\22\ The
most significant biological weapons program focused on
developing an anthrax bioweapon but the group also pursued
ricin and botulinum toxins. Al Qaeda explored dispersal methods
for those biological weapons, and operatives were found to
possess crop duster manuals and appeared to have tried to
purchase a crop dusting airplane. In 2003, associates of the
Jordanian extremist Abu Musab al Zarqawi, who headed Al-Qaeda
in Iraq and received the title ``Emir of Al Qaeda in the
Country of Two Rivers,'' were arrested as they prepared ricin
attacks against the London underground subway system.\23\ The
Administration's National Strategy concluded with respect to al
Qaeda that ``it is prudent to assume that its intent to pursue
biological weapons still exists.''\24\
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\18\For a discussion of the biological weapons threat from al
Qaeda, see generally Al Qaeda Weapons of Mass Destruction Threat: Hype
or Reality?; see also George Tenet, At the Center of the Storm (New
York: HarperCollins, 2007).
\19\National Strategy for Countering Biological Threats at 2.
\20\Janet Napolitano, ``Common Threat, Collective Response:
Protecting Against Terrorist Attacks in a Networked World,'' speech
before the Council on Foreign Relations, (July 29, 2009), available at
http://www.cfr.org/publication/19929/
common_threat_collective_response.html (last accessed April 12, 2010).
\21\Al Qaeda Weapons of Mass Destruction Threat: Hype or Reality?,
at 23.
\22\Ayman Zawahiri, Osama bin Laden's deputy, had a master's degree
in surgery and reportedly oversaw al Qaeda's efforts to establish a
biological weapons laboratory by microbiologist Dr. Rauf Ahmed and to
obtain a lethal strain of anthrax by biochemist Yazid Sufaat. Other
operatives such as Mubarek al-Duri and Abu Rida Mohammed Bayazid had
degrees in biology and physics, respectively. Id. at 12, 14, 21.
\23\Id. at 25.
\24\National Strategy for Countering Biological Threats at 2.
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However, the October 2001 anthrax attacks show that the
threat of bioterrorism is not limited to al Qaeda. In February
2010, the Department of Justice concluded that Bruce Ivins, a
researcher with the U.S. Army Medical Research Institute of
Infectious Diseases, was the sole perpetrator of those five
letter attacks.\25\ The attacks demonstrated that a single
researcher could prepare and carry out a biological attack
without detection by his peers. Other notable examples of
bioterrorism include the 1993 attack by a Japanese religious
cult in which they sprayed a non-virulent strain of anthrax off
their headquarters building. That attempt was not detected
until years later when authorities investigated the cult's
successful sarin gas attack on the Tokyo subway system. In
1984, another religious cult, the Rajneeshee sect in Oregon,
launched a series of salmonella food poisoning attacks that
sickened hundreds.
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\25\See Department of Justice, Amerithrax Investigative Summary
(February 19, 2010), available at http://media.washingtonpost.com/wp-
srv/politics/documents/amx-investigative-
summarypdf?sid=ST2010021904257 (last accessed April 12, 2010).
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The President's National Strategy concluded: ``[w]e are
fortunate that biological threats have not yet resulted in a
catastrophic attack or accidental release in the United States.
However, we recognize that: (1) the risk is evolving in
unpredictable ways; (2) advances in the enabling technologies
will continue to be globally available; and (3) the ability to
exploit such advances will become increasingly accessible to
those with ill intent as the barriers of technical expertise
and monetary costs decline.''\26\
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\26\National Strategy for Countering Biological Threats at 2.
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B. THE BIOSECURITY RISK OF DANGEROUS PATHOGEN LABORATORIES
B.1. Background
The Prevent WMD Commission's December 2008 final report
gave particular focus to the threat of bioterrorism, finding
that the nation's counter-WMD planners have not adequately
prioritized addressing what is the most likely catastrophic WMD
threat. The commissioners stated ``the more that sophisticated
capabilities, including genetic engineering and gene synthesis,
spread around the globe, the greater the potential that
terrorists will use them to develop biological weapons. The
challenge for U.S. policymakers is to prevent that potential
from becoming a reality by keeping dangerous pathogens--and the
equipment, technology and know-how needed to weaponize them--
out of the hands of criminals, terrorists, and proliferant
states.''\27\ Specifically the Commission offered its first
recommendation on the issue of domestic biosecurity, urging a
comprehensive review of the way we regulate dangerous
pathogens, how researchers are trained in biosecurity
practices, how the laboratories that work on these agents are
secured, and how we engage the life sciences community who
perform this work.
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\27\World at Risk at 23. Emphasis on the role for policy makers
added.
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While the U.S. must give considerable attention to
discovering and disrupting terrorist use of dangerous
pathogens, we must simultaneously address our own potential
vulnerabilities--the security of the pathogen stocks our
scientists use for legitimate research, commercial, and public
health purposes. As the commissioners put it: ``Although
dangerous pathogens such as the anthrax bacterium can be
isolated from natural sources, it would generally be easier for
terrorists to steal or divert well-characterized `hot' strains
from a research laboratory or culture collection.''\28\ Indeed,
all prominent examples of modern bioterrorism or crimes
involving biological agents used material obtained from
laboratory sources or pathogen repositories--not pathogens
independently derived from natural sources by the perpetrators
of the attack.\29\
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\28\Id. at 24.
\29\The 1995 plague samples obtained by the neo-nazi extremist
Larry Wayne Harris were ordered from the pathogen repository American
Type Tissue Collection (ATCC); the 1984 salmonella strain used by the
Rajneeshee religious cult to contaminate Oregon restaurant salad bars
came from a commercial distributor and was a common strain found in
pathogen repositories; the 1993 nonvirulent anthrax strain used by the
Japanese Aum Shinrikyo religious cult was a common vaccine strain used
in veterinary medicine; the 1996 intentional shigella infection of
Dallas, Texas hospital staff by a co-worker was obtained from the
hospital's collection; and, the 2001 anthrax postal mailing attacks was
traced back to a U.S. Army research institute.
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Unfortunately, although the government has taken steps to
secure U.S. laboratories working on the most dangerous
pathogens, robust laboratory security has remained elusive. The
government must do more to address these security deficiencies.
In 2008, the Government Accountability Office (GAO) reported
that two of the nation's five highest level containment labs,
which handle some of the most dangerous pathogens, had
significant deficiencies in accepted practices for securing
facility perimeters.\30\ High-containment labs are designed to
prevent the release of infectious agents that can spread
through the air. The highest level of these labs, those labeled
biosafety level 4, is often used for research on pathogens for
which there are inadequate or no therapies to treat the disease
they cause. In July of 2009, GAO observed in an updated report
that deficient facilities made some improvements in perimeter
security, but GAO continued to find fault with federal
oversight of these facilities. GAO noted that the security
improvements came as a result of public attention and not from
any new requirements or directives by government auditors.\31\
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\30\Biosafety Laboratories: Perimeter Security Assessment of the
Nation's Five BSL-4 Laboratories GAO-08-1092, September 17, 2008.
\31\Biosafety Laboratories: BSL-4 Laboratories Improved Perimeter
Security Despite Limited Action by CDC GAO-09-851, July 7, 2009.
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A related GAO report identified additional risk factors
beyond perimeter security that increase the likelihood of
laboratory accidents or intentional misuse of dangerous
pathogens at high-containment facilities.\32\ GAO noted that
the United States is currently undergoing a construction boom
of new high-containment laboratories and warned of insufficient
attention to identifying current high-containment laboratory
capacity or to planning how the new capacity will be used and
maintained. Many of the planned facilities have poorly defined
mission needs or objectives, insufficient maintenance resources
and incomplete biosafety and biosecurity systems.
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\32\High-Containment Laboratories: National Strategy for Oversight
is Needed. GAO-09-574, September 2009.
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The Obama Administration agrees that more needs to be done
to improve lab biosecurity. The National Strategy for
Countering Biological Threats calls for reducing the risk posed
by deliberate use of pathogens and toxins ``by limiting ready
access to known virulent strains of high-risk pathogens and
toxins.'' \33\ It further recognizes that the government needs
to optimize ``our domestic laws, regulations, policies and
practices for securing high risk pathogens and toxins and
[provide] detailed guidance for improved compliance.''
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\33\National Strategy for Countering Biological Threats at 13.
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Biological Select Agent and Toxin Program
The current regime regulating dangerous pathogens--the
Biological Select Agent and Toxin (BSAT) Program--simply
doesn't offer the tools necessary to improve the situation. The
BSAT program was established in The Antiterrorism and Effective
Death Penalty Act of 1996 (P.L. 104-132) after a neo-Nazi
extremist in 1995 obtained a strain of Yersinia pestis, the
causative agent of plague, from a U.S. pathogen research
repository. At the time there were no prohibitions against
unapproved acquisition of dangerous disease agents, and the
perpetrator eventually pleaded guilty only to wire fraud. The
statute authorized the Centers for Disease Control and
Prevention (CDC) to promulgate regulations establishing a list
of dangerous pathogens and toxins and for controlling the
transfer of those pathogens to appropriate research facilities.
Select agents were to be made available only to people and
laboratories that had registered with the CDC. The new law did
not, however, impose penalties on individuals for
inappropriately possessing select agents themselves, attainable
via such means as by acquiring select agents overseas or
isolating the pathogens from the environment.
Following the October 2001 anthrax attacks, Congress passed
the USA PATRIOT Act (P.L. 107-56), which added criminal
penalties for the illicit possession and use of biological
threat agents by anyone who cannot prove reasonably that they
are using a biological agent, toxin, or delivery system for
purposes of ``prophylactic, protective, bona fide research, or
other peaceful purposes.''\34\ In 2002, Congress amended the
statute authorizing the BSAT program in the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002
(P.L. 107-188) to require regulations for the possession and
use of select agents regardless of the manner in which they
were acquired.\35\
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\34\USA PATRIOT Act of 2001, P.L. 107-56, 115 Stat. 0385-386,
(amending 18 U.S.C. Sec. 175), (2002).
\35\Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, P.L. 107-188, 116 Stat. 637-662 42 U.S.C.
Sec. 262a, 7 U.S.C. Sec. 8401, 7 U.S.C. Sec. 8411 (2002). The
regulations are contained in CDC Select Agents Regulations (42 CFR Part
73) and APHIS Select Agents Regulations (7 CFR Part 331 and 9 CFR Part
121), available at http://
www.selectagents.gov/Regulations.html.
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Insufficient focus on bioterrorism potential
The BSAT regulations are intended to keep dangerous
pathogens that could be used as bioweapons out of the hands of
terrorists. In practice, the regulations cast such a wide net
that they produced a bloated BSAT list, one that impedes
sufficient focus on securing the most dangerous agents, while
imposing excessive security burdens on research where it is not
warranted. Instead of defining the pathogens subject to its
regulation with reference to the material's ability to be
weaponized, the authorizing statute mandated the use of a
threat to public health as the main criteria for inclusion on
the list.\36\ No criteria assess the agent's suitability to be
weaponized or the effectiveness of the potential weapon to
cause significant casualties or economic repercussions. The
BSAT regulations are also ``all or nothing''--imposing the same
security requirements on all agents, regardless of whether the
bioterrorism risk they pose is little, moderate, or
significant. As a result, the BSAT list has ballooned to 82
listed pathogens and toxins, many of which are believed
unsuitable for the development of effective biological weapons
but all of which face the same regulations. Some of these
unsuitable agents may be able to cause significant disease
outbreaks in a natural setting but lack features necessary for
an effective biological weapon, such as ease in producing
significant weapons material, stability in delivery systems,
and the ability to be broadly disseminated. In contrast, for
purposes of developing medical countermeasures (MCMs) against
potential WMD threats, DHS recognizes just 11 biological agents
as material threats to the U.S. population sufficient to affect
national security.\37\
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\36\P.L. 107-188, 42 U.S.C. Sec. 262a, 116 Stat. 637-638 (2002). In
determining whether to include an agent or toxin on the list under
subparagraph (A), the Secretary shall consider--
``(I) the effect on human health of exposure to the agent or toxin;
``(II) the degree of contagiousness of the agent or toxin and the
methods by which the agent or toxin is transferred to humans;
``(III) the availability and effectiveness of pharmacotherapies and
immunizations to treat and prevent any illness resulting from infection
by the agent or toxin; and
``(IV) any other criteria, including the needs of children and
other vulnerable populations, that the Secretary considers appropriate.
\37\The authority to make such declarations is given in the Project
Bioshield Act of 2004, P.L. 108-276, 118 Stat. 844, 42 U.S.C.
Sec. 247d-6b (2004). Under the Act, the Secretary of Homeland Security
issues Material Threat Determinations (MTDs) for chemical, biological,
and radiological agents that could be used in a weapon endangering
enough people to threaten national security. MTDs issued for biological
agents include Botulinum Toxin (Clostridium botulinum), Plague
(Yersinia pestis), anthrax (Bacillus anthracis), multi-drug resistant
anthrax (Bacillus anthracis), smallpox (Variola Major), Tularemia
(Fracisella tularensis), Typhus (Rickesttsia prowazekii), Glanders
(Burkholderia mallei), Meliodosis (Burkholderia pseudomallei), Viral
Hemorrhagic Fevers (Filovirus family such as Marburg or Ebola), and
Viral Hemorrhagic Fevers (Arenavirus, Flavivirus, and Bunavirus
families).
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The apparent over-reach of the current regulatory regime
has had serious consequences. Not only has it diluted
government security efforts, but it also has imposed resource
constraints on the labs themselves and resulted in confusing
and often inconsistent regulatory overlaps.
Inconsistent and overlapping regulatory requirements for institutions
The large size of the list has meant that the regulations
sweep in a large number of institutions and personnel,
affecting many laboratories that do not contain pathogens of
significant bioweapon potential and people who do not work on
the most dangerous pathogens, but all of whom require, under
current law, a similar investment of limited governmental
regulatory resources. Approximately 400 institutions and 15,000
personnel have had to register to conduct research on 82 select
agents. Laboratories handling human pathogens are regulated by
the Centers for Disease Control and Prevention (CDC) of the
Department of Health and Human Services (HHS), while
laboratories working with animal or plant pathogens face
regulation from the Department of Agriculture (USDA).
Facilities working with pathogens that pose a threat to both
human and animal health, termed ``overlap agents'', can choose
to be regulated either by the CDC or USDA. Institutions, along
with the officials who oversee the institution's BSAT program
compliance, must re-apply for registration every three years
and renewal is dependent on a site visit by federal inspectors.
Institutions performing select agent research often face a
number of additional security requirements outside the BSAT
program that can prove confusing or inconsistent. These
requirements may come from their home agency or institution,
local and state regulators, federal funding agencies, or
overlapping regulatory agencies. Regulated entities frequently
report that the requirements and inspections that result from
this broad array of oversight entities are poorly coordinated,
often inconsistent with one another, and expensive in both
their financial cost and the lost research time required to
prepare and undergo multiple inspections. The BSAT regulations
also lack specificity in their implementation requirements for
areas such as physical security or inventory accountability,
which has led to variability among oversight agencies in
interpreting regulatory compliance. As a result, registered
entities often report confusing or contradictory security
requirements imposed on them by inspecting agencies.\38\
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\38\Personal communication with the Committee, and ``Report of the
Working Group on Strengthening the Biosecurity of the United States.''
January 8, 2010, http://www.hhs.gov/aspr/omsph/biosecurity/biosecurity-
report.pdf (Last Accessed September 30, 2010), at 4.
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Inadequate scrutiny of individuals handling pathogens
At the same time, the individuals handling select agents
are not subject to sufficient scrutiny, given the risks posed
by the materials they handle. The FBI conducts a Security Risk
Assessment on these individuals every 5 years with little to no
follow-up between applications. The Assessment involves
checking a series of databases to determine whether the
individual has any prohibited characteristics.\39\ The law
prohibits anyone with known associations with terrorists, a
criminal record, a history of mental health problems, or is an
unlawful alien from being granted clearance to work with select
agents.\40\ Significantly, while the security risk assessment
examines domestic criminal records and reviews a few broad
international criminal databases, it does not include a check
of criminal records in the particular home nations of
applicants originating from foreign countries. The FBI recently
established a system under which the bureau is automatically
notified if an approved select agent user is arrested and
fingerprinted. Institutes hiring BSAT qualified personnel
report that they cannot access information pertaining to any
prior biosecurity concerns regarding the applicant at another
institution because of the previous employer's liability
concerns. Employers are not required to report to the
regulating agency detrimental behavior of BSAT personnel
resulting in their termination.
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\39\Presentation at the June 2010 Select Agent Workshop by FBI
Criminal Justice Information Service and the Select Agent Programs of
HHS and USDA entitled ``Security Risk Assessments--Overview, FBI
Updates, Visitor Movement.'' available at http://www.selectagents.gov/
resources/FULL%20WORKSHOP%20PRESENTATION%20START%20TO%20FINISH.pdf
(last accessed August 27, 2010). Slides 164-165. The databases checked
during the Security Risk Assessment for Select agent program applicants
are: Central Index System (CIS), Computer Linked Application
Information Management System (CLAIMS), Deportable Alien Control System
(DACS), National Automated Immigration Lookout System (NAILS II),
Nonimmigrant Information System (NIIS), Student and Exchange Visitor
Information System (SEVIS), Redesigned Naturalization Application
Casework System (RNACS), Refugee, Asylum, and Parole System (RAPS),
Enforcement Case Tracking System (ENFORCE), Treasury Enforcement
Communications System (TECS), Interstate Identification Index (State/
Local criminal history), Automated Case Support (ACS; FBI case file
database), National Crime Information Files including: Foreign Fugitive
File, Deported Felon File, Protection Order File, Wanted Person File,
U.S. Secret Service Protective File, SENTRY File (Bureau of Prisons),
Convicted Person on Supervised Release File, Convicted Sexual Offender
Registry.
\40\USA PATRIOT Act of 2001, P.L. 107-56, 115 Stat. 0386, (amending
18 U.S.C. Sec. 175b), (2002).
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Federal agencies and some state and private institutions
conducting select agent research have chosen to implement
additional safeguards for personnel handling select agents that
go beyond personnel examinations required under the BSAT
program. Because these measures are undertaken on the
initiative of the individual select agent research entities,
there is inconsistent application of which measures are
employed and how strenuously they are enacted. These more
rigorous employee evaluation and monitoring policies are
sometimes termed Personnel Reliability Programs (PRPs). PRPs
are designed to account for the trustworthiness, competency and
stability of users given access to select agents and toxins.
PRPs can include a wide range of practices from background
investigations, mental health screening and credit checks to
continuous monitoring and reporting programs.\41\
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\41\Some sectors such as sensitive nuclear research also include
the use of polygraphs but, outside of the intelligence community,
polygraphs do not appear to be applied to biological select agent
research. For further discussion of PRP see: Report of the Defense
Science Board Task on Biological Safety and Security Program. May 2009.
http://www.acq.osd.mil/dsb/reports/ADA499977.pdf; (Last Accessed
September 30, 2010) Enhancing Personnel Reliability among Individuals
with Access to Select Agents. May 2009. http://oba.od.nih.gov/
biosecurity/biosecurity_documents.html (Last Accessed September 30,
2010); and, Responsible Research with Biological Select Agents and
Toxins. National Research Council of the National Academies. September
2009.
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Recent reports on improving laboratory biosecurity
Recognizing the need to improve laboratory biosecurity,
particularly for BSAT research, the federal government has
conducted a series of studies examining various aspects of the
current regulatory scheme and how it might be improved. Some of
the most pertinent to this legislation have recently been
concluded and are discussed further below, including those that
were released following the Committee's consideration of this
legislation.
In January 2009, the outgoing administration issued an
Executive Order (13486) that established the ``Working Group on
Strengthening the Biosecurity of the United States,'' co-
chaired by the Departments of Health and Human Services and
Defense. The Executive Order called for the working group to
look at the existing security regime and recommend any
necessary statutory or regulatory changes to ensure a uniform
and effective regulatory system for all facilities and
individuals handling dangerous pathogens.\42\
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\42\Executive Order 13486 ``Strengthening Laboratory Biosecurity in
the United States.'' January 9, 2009. http://edocket.access.gpo.gov/
2009/pdf/E9-818.pdf (Last Accessed September 30, 2010).
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The working group established by the 2009 Executive Order
tasked the National Academies to review the select agent
program.\43\ The panel appointed by the National Academies
recommended dividing the select agent list into stratified
groups based on risk tiers, establishing minimum physical
security requirements that satisfy the requirements of all
relevant federal agencies, giving standardized training to all
agency inspectors, establishing an advisory committee of
stakeholders to review policies, and making available a
separate category of funding to support security measures at
select agent laboratories.\44\
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\43\Responsible Research with Biological Select Agents and Toxins.
National Research Council of the National Academies. September 2009.
\44\Id. at 2-5.
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The working group released its final report in January
2010, offering a number of findings and recommendations. It
concurred with the observations above (1) that the BSAT list
contains pathogens posing differing levels of risk and as a
result should be either reduced or divided into different
regulatory tiers; (2) that the program suffers from numerous
uncoordinated federal inspections and oversight mandates, each
with its own performance expectations or regulatory
requirements; and (3) that registered entities do not clearly
understand what they must do to comply with select agent
program requirements.\45\
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\45\``Report of the Working Group on Strengthening the Biosecurity
of the United States'' January 8, 2010. http://www.hhs.gov/aspr/omsph/
biosecurity/biosecurity-report.pdf (Last Accessed September 30, 2010),
at 4.
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The working group supplied a recommendation to address each
of these key findings:
(1) Perform a risk assessment for each select agent and
toxin on the BSAT list and develop a stratification scheme that
includes biodefense and biosecurity criteria, as well as risk
to public health, so that security measures may be implemented
based upon risk.
(2) Enhance U.S. Government coordination of oversight and
inspections as well as institutional implementation,
compliance, oversight, and accountability.
(3) Provide comprehensive guidance on inventory management
and recordkeeping requirements, approaches, and templates.\46\
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\46\Id. at 4.
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The working group also recommended improved vetting and
continuous monitoring measures, consisting of some common PRP
measures, of approved BSAT users and the development of minimum
prescriptive physical security standards.
A number of other federally sponsored reports have examined
these and other aspects of laboratory biosecurity. For example,
HHS' National Science Advisory Board for Biosecurity,
established by Congress in the Pandemic and All-Hazards
Preparedeness Act of 2006, released in May 2009 a report
entitled ``Enhancing Personnel Reliability among Individuals
with Access to Select Agents.''\47\ The report recommended,
among other things, strengthening the background check process
for select agent applicants and reducing the list of select
agents and toxins. While the report found no need for a
national personnel reliability program at this time, it found
that ``personnel reliability programs can help to reduce but
cannot eliminate the risk of an insider threat.''\48\ The
report also recommended that ``institutions that are engaged in
select agent research should review their employment practices
and other existing select agent personnel reliability-related
policies to determine whether there is a need to implement
additional personnel reliability measures.''\49\
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\47\The National Science Advisory Board for Biosecurity was
established in the Pandemic and All-Hazards Preparedness Act, P.L. 109-
417, 120 Stat. 2851, 42 U.S.C. Sec. 262a note. The report is entitled
``Enhancing Personnel Reliability Among Individuals with Access to
Select Agents.'' May 2009. http://oba.od.nih.gov/biosecurity/
biosecurity_documents.html (Last Accessed September 30, 2010).
\48\Id. at 5.
\49\Id. at 11.
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The Department of Defense (DOD) also initiated a security
review of its own select agent research policies, which in many
aspects exceed CDC regulations.\50\ Among the DOD panel's
recommendations: increase cybersecurity efforts, maintain the
biological personnel reliability program, and improve
inspection procedures to reduce their burden on inspected
facilities. DOD's report also pointed to the expense of
complying with biosecurity programs and the need for additional
financial support for regulated entities.
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\50\Report of the Defense Science Board Task on Biological Safety
and Security Program. May 2009. http://www.acq.osd.mil/dsb/reports/
ADA499977.pdf (Last Accessed September 30, 2010).
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Another group--the Trans-Federal Task Force on Optimizing
Biosafety and Biocontainment Oversight, chaired by officials
from HHS and USDA with representatives from other federal
agencies--focused primarily on the safe operation of high-
containment laboratories rather than biosecurity practices.
Still, the report offered a number of proposals relevant to
both biosafety and biosecurity of high-containment
laboratories.\51\ The Task Force recommended establishing
coordinated and improved oversight, requiring registration of
high-containment laboratories, implementing improved training
of laboratory personnel, and ensuring proper maintenance
resources for facilities housing dangerous pathogens.
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\51\Report of the Trans-Federal Task Force on Optimizing Biosafety
and Biocontainment Oversight. July 2009. http://www.phe.gov/
Preparedness/legal/boards/biosafetytaskforce/Documents/
transfedbiocontainmentrpt092009.pdf (last accessed September 30, 2010).
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B.2. Title I of the WMD Prevention and Preparedness Act of 2009--
Enhanced Biosecurity
The WMD Prevention and Preparedness Act responds to many of
the collective findings and recommendations of these reports.
Title I of the bill establishes a risk-based approach to
improving security at U.S. biological laboratories by
heightening security standards for labs handling the most
dangerous pathogens while reducing the regulatory burden on
laboratories handling agents that aren't suitable for use in an
attack. In response to the general consensus that the BSAT
lists many pathogens that pose little bioterrorism risk, this
title divides the BSAT list into tiers and encourages the de-
listing or demotion of agents that are currently over-
regulated. It enhances security on only those BSAT pathogens of
greatest bioterrorism risk and provides for coordinated
inspection policies and efforts to reduce the confusion over
biosecurity requirements and the expense of complying with the
inspections. Provisions in this title also establish a
biosecurity grant program to assist institutions with meeting
enhanced biosecurity requirements. And, to promote coordination
among federal agencies and with local responders, the title
provides for greater information sharing, with safeguards
against inappropriate disclosure.
The bill would divide the BSAT list into three tiers. A new
``Tier I'' of select agents would be composed of a small subset
of the current list, those that the Secretary of Health and
Human Services or Secretary of Agriculture, as appropriate,
determines to pose the greatest threat, as defined by having
clear potential for weaponization and use in a biological
attack causing significant casualties. Based on expert opinion
and DHS Material Threat Determinations, the Committee expects
that between roughly 5 and 11 of the 82 agents currently on the
BSAT list would gain Tier I designation.\52\ HHS and USDA would
retain responsibility for the biosafety and scientific
regulation of Tier I agents, while DHS--the department
possessing the government's infrastructure protection
expertise--would ensure adequate physical and personnel
security measures for Tier I agents.
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\52\This range is derived from analysis of biological agents that
possess both the capability of being used to make a stable biological
weapon as well as to cause significant casualties if deployed. DHS has
issued Material Threat Determinations for 11 biological agents for
purposes of identifying which pathogens to develop medical
countermeasures for under Project Bioshield. Some or all of these
agents may also possess the characteristics justifying a Tier 1
designation in this legislation.
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This legislation gives DHS the principal role in securing
Tier 1 agents because the department is specifically charged
with increasing the security of the nation's critical
infrastructure across myriad sectors. An example of DHS working
with the private sector to secure critical infrastructure is
DHS's work in the chemical security area. At Congress's
direction, DHS implemented and regulates the Chemical Facility
Anti-Terrorism Standards, or CFATS--a program that requires
science-based security standards development, vulnerability
assessments, and site security plans while not impeding this
critical infrastructure's functioning.\53\ DHS's involvement in
securing laboratories handling Tier 1 agents is expected to
bring expertise to address security shortfalls in the current
select agent regulatory regime, including in physical security,
personnel screening, and information sharing with state and
local law enforcement, first responders and emergency
officials.
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\53\Department of Homeland Security Appropriations Act, 2007, P.L.
109-295, section 550, (2006).
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The current BSAT Program would in effect become the
regulatory scheme for a second tier, encompassing agents that
meet the preexisting BSAT program criteria plus a new criterion
requiring consideration of their suitability to be weaponized.
The new criterion would raise the bar, requiring an examination
of not just the agent's public health consequences but also
whether it poses a bioterrorism risk. Combined with a mandated
review of all agents on the BSAT list, this measure is intended
to enable the removal of agents with little or no bioterrorism
risk from the BSAT program. This second tier would exist as the
BSAT program in its current form without the new enhanced
biosecurity measures and would still be regulated for security,
biosafety, and scientific purposes by HHS and USDA.
A new third category called ``Registry Agents'' would
comprise the final and lowest risk tier. Registry agents would
be those that have some potential to pose a severe threat to
public, animal or plant health, but whose potential for use in
a biological attack has not been established, whether because
ease in producing significant weapons material, stability in
delivery systems, or the ability to be broadly disseminated is
questionable. This tier would likely include agents previously
included in the Select Agent Program, but not meeting the
criteria for inclusion in the top two regulatory tiers as
defined in this legislation. Laboratories that handle Registry
Agents would have to register with HHS, but would not face
further regulation.
This measure would facilitate the removal from the BSAT
program of agents that currently pose little bioterrorism risk
while at the same time ensuring continued visibility of the
agents if intelligence or threat analysis indicates an
increased risk of their use in a bioterrorist event. The
registry agent category would also facilitate the solicitation
of information on the characteristics of emerging threat agents
and how they are used in research. This would allow full
consideration of these agents for possible inclusion in the
BSAT program, if warranted, without subjecting them to the
regulatory burden before the threat is clearly established.
Currently, the federal government has little visibility into
the research being conducted on emerging pathogens with
bioweapon potential and can gain more insight into it only if
and when it subjects the research to the entire scope of select
agent regulation oversight.
Title I also directs new, enhanced biosecurity measures at
agents on the Tier I BSAT list, but leaves the remaining BSAT
agents at their current level of regulation, or brings them to
an even lower one if they are delisted to the new Registry
Agent category. The title directs DHS to promulgate new
biosecurity regulations that include standards for (1)
personnel reliability programs, (2) biosecurity training of
responsible officials and laboratory personnel, (3) laboratory
risk assessments, and (4) risk-based laboratory security
performance expectations. While not appropriate for every level
of biological research, these elements are vital to securing
research with Tier I BSAT agents.
Personnel reliability programs, sometimes alternatively
described as personnel assurance or continuous monitoring
programs, play a role in ensuring that people with access to
the most dangerous pathogens are not just run through a name
check in databases once every five years, but are part of a
program that continuously evaluates whether the person develops
new restricting characteristics or extreme changes in behavior.
Laboratory risk assessments identifying a particular
laboratory's vulnerabilities and requirements for conducting
specific research in a safe and secure manner are the
cornerstone for implementing a robust security plan.
Unfortunately, current practice is often variable in what is
examined, the detail to which risks are identified, and who
conducts the assessment. This title will help bring uniform
expectations to the laboratory risk assessments that
institutions conduct. Finally, based on these risk assessments,
the regulations mandated by the bill would better define
physical security requirements for Tier I labs eliminating much
of the confusion among regulated entities due to conflicting
expectations from different federal agencies.
While this legislation creates a framework for the
stratification of select agents and for the development of
enhanced security measures for Tier I agents, it is not
prescriptive in what those measures will entail. As mentioned
previously, there is a large body of work that makes numerous
recommendations as to how to improve laboratory biosecurity.
This legislation provides the vehicle by which those
recommendations can be considered and implemented during a
rulemaking process that brings the relevant stakeholders fully
to the table.
Specifically, Title I directs the Secretary of Homeland
Security, in consultation with the Secretaries of Health and
Human Services and Agriculture, to establish Tier I biosecurity
standards through a negotiated rule-making. In the negotiated
rule-making, a committee of relevant parties would be assembled
to seek to produce a consensus recommendation to the Secretary
of Homeland Security.\54\ This committee would include federal
agencies, academic and private research institutions, and other
key stakeholders. The committee would make recommendations to
the Secretary within six months of the bill's enactment, and
the Secretary would promulgate a final rule within a year. The
bill requires the negotiated rulemaking committee and the
Secretary to consider the full spectrum of views, reports and
recommendations of recent scientific and interagency working
groups and how to minimize disincentives posed by security
standards to biological research.
---------------------------------------------------------------------------
\54\The procedures for negotiated rulemakings are prescribed in the
Negotiated Rulemaking Act of 1990, P.L. 101-648, 5 U.S.C. 561 et seq.
(1990).
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The Secretary of Homeland Security, in consultation with
the Secretaries of Health and Human Services and Agriculture,
would enforce the regulations promulgated for laboratories
handling Tier 1 agents through issuance of regulations,
guidance, and by performing inspections. These compliance
efforts would include participation of HHS and USDA personnel
as appropriate. While DHS is responsible for inspecting whether
staff handling Tier 1 agents are in compliance with the
training standards, HHS is responsible for developing or
approving the training programs such staff will take, as the
programs likely will apply across both biosecurity and
biosafety competencies. In addition to inspections, DHS is
given authority to impose civil penalties for violations of the
regulations, as well as intermediate sanctions aimed at
correcting deficiencies in lieu of civil penalties.
In addition to stratifying the BSAT list and putting in
place security measures that are commensurate with the risk,
this title includes additional measures to bring efficiency to
the oversight of BSAT research and to help support institutions
conducting BSAT research. The title directs agencies reviewing
a BSAT research institution for regulatory or contractual
compliance with the BSAT regulations to carry out those reviews
jointly to the extent practicable. In order to reduce divergent
or conflicting expectations among federal agencies on how to
comply with the BSAT regulations, the bill directs agencies to
coordinate and agree upon inspection procedures. Finally, to
reduce the need for agencies to conduct redundant inspections
simply due to lack of access to inspection results from another
agency, this title requires that agencies inspecting for
regulatory or contractual compliance share their reports with
other agencies that have a vested interest in the inspected
facility.
Institutions with BSAT programs often face significant
costs to physically secure, monitor, and conduct the research.
These costs can exceed the allowable overhead of the research
grants that fund much of this research. This title establishes
a DHS administered grant program to help offset additional
costs that may be associated with the enhanced biosecurity
measures associated with the new Tier I BSAT regulations. It
also encourages the use of the DHS voluntary vulnerability
assessment program that can help BSAT research institutions
access the Department's expertise in evaluating site
vulnerability at no cost to the institution and in a manner
that preserves confidentiality.\55\
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\55\Since the Committee consideration of this legislation, the
Administration issued Executive Order 13546, Optimizing the Security of
Biological Select Agents and Toxins in the United States, on July 2,
2010. Several of the measures laid out in the Executive Order are
consistent with those in this legislation, including risk-based tiering
of the select agent list and designation of the most dangerous
pathogens as ``Tier 1'' select agents; enhancing security on Tier 1
pathogens by developing standards for personnel reliability and
laboratory physical security; evaluating whether biological agents that
pose little or no bioterrorism risk can be removed from the select
agent list; and coordinating the oversight of BSAT laboratories
conducted by different Federal agencies for regulatory and contractual
purposes. The Executive Order diverges significantly from this
legislation, however, by giving DHS only a peripheral role in the rule
making process and no clearly identified role in its implementation.
The DHS role under the Executive Order is limited to participation on
an interagency advisory panel chaired by HHS and USDA and leading the
panel's working group on physical and cybersecurity. The interagency
advisory panel was given four months to organize itself and its working
groups, analyze its options, and develop consensus standards. HHS and
USDA have an additional eleven months after the recommendations are
submitted to develop draft regulations. Final rules are to be noticed
by twenty-seven months after issuance of the Executive Order.
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C. ENSURING A ROBUST RESPONSE TO A WMD ATTACK
C.1. Background
The government must work not only to prevent a bioterrorist
or other WMD attack; it also must prepare to care for its
people in the event terrorists succeed in launching such an
assault. We must stand ready to quickly and comprehensively
deliver so-called MCMs--medical countermeasures like
antibiotics, toxin antidotes, or radiation treatments--to those
in need. We must be prepared to effectively communicate what is
going on and what needs to be done, both with first responders
and with affected populations. And we must know how to
scientifically limit the impact of any attack that occurs by
having the knowledge and ability necessary to analyze, track
and contain dangerous pathogens once they are released.
Unfortunately, this all is something the government is not yet
prepared to do.
In January 2010, the Prevent WMD Commission issued a report
card grading the government's progress in implementing the
Commission's December 2008 recommendations.\56\ The Commission
found improvements in a few areas, but it gave the government a
highly troubling `F' for its inability to respond quickly to
and prevent mass casualties from a biological attack.\57\
Unfortunately, the government does not dispute the basis for
this grade. The government has recognized it must do more to
strengthen our preparedness efforts for all WMD threats and
more fully inform and engage the public in its activities as
stated by Secretary of Homeland Security, Janet Napolitano, in
a recent speech, ``We may be better prepared as a nation than
we were on 9/11, but we are nowhere near as prepared as we need
to be.''\ 58\
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\56\Prevention of WMD Proliferation and Terrorism Report Card.
Commission on the Prevention of Weapons of Mass Destruction
Proliferation and Terrorism. January 2010. Available at http://
www.preventwmd.gov/static/docs/report-card.pdf (Last Accessed September
30, 2010).
\57\Id. at 6.
\58\From Homeland Security Secretary Janet Napolitano's July 29,
2009 speech before the Council on Foreign Relations entitled ``Common
Threat, Collective Response: Protecting Against Terrorist Attacks in a
Networked World.''
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Dispensing medical countermeasures
Quick dispensing of the correct medicines could
tremendously diminish the numbers of those injured or killed if
a weapon of mass destruction hits our homeland. To the
government's credit, it has long maintained a store of medicine
and medical supplies, managed by the CDC and called the
Strategic National Stockpile (SNS). The SNS contains rapid
deployment packages that the federal government can deliver to
any designated state receiving area within 12 hours with
additional supplies available within 24 hours. In the federal
government's view, it is then up to state and local authorities
to dispense the medicines to the people who need them.
Unfortunately, getting materials the last mile to those
people has turned out to be the system's greatest weakness. As
a 2008 Institute of Medicine-sponsored workshop found: ``if we
do not have the mechanisms to get these lifesaving medicines in
the hands of Americans after such an attack or multiple attacks
within a very short timeframe, we have squandered an
opportunity to save lives.''\59\ The consensus from the
workshop was that ``the nation is not comprehensively prepared
to mount the greatest possible defense.''\60\ The Centers for
Disease Control and Prevention (CDC) has established a program
called the Cities Readiness Initiative. That program has
increased the dispensing capability of some cities, but covers
only 72 metropolitan regions representing an estimated 57% of
the U.S. population. What's more, not one of the covered
metropolitan regions can yet meet the program's goal of
delivering antibiotics to its entire population within 48
hours; it remains unclear how long after the attack it would
take for those jurisdictions to provide treatment to their
populations or if the help would come too late.\61\ A
complimentary approach involves using the U.S. Postal Service
to rapidly deliver a short course of antibiotics following a
biological attack to gain time for more substantial resources
to be deployed. The approach has been exercised and is
currently being piloted in one city but is still not deployed
widely.\62\
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\59\Dispensing Medical Countermeasures for Public Health
Emergencies: Workshop Summary. Miriam Davis, Marnina S. Kammersall, and
Bruce M. Altevogt. Forum on Medical and Public Health Preparedness for
Catastrophic Events. The National Academies Press. p.31. March 3, 2008.
\60\Id. at 32.
\61\For a review of the program see ``Initial Evaluation of the
Cities Readiness Initiative'' Henry H. Willis et al. Rand Corporation.
2009.
\62\The U.S. Postal Service (USPS) Plan has been exercised in 2006
and 2007 in Seattle, Boston, and Philadelphia with mock antibiotics
being dispensed to tens of thousands of homes and took only 6-9 hours.
Since 2007 HHS and USPS have run a pilot program in the Minneapolis-St.
Paul area of Minnesota. The pilot is assessing the ability of the
program to solicit and train postal service employees, collaborate with
local law enforcement, and deploy personal medkits to USPS volunteers
so they are prepared to deploy in the event of an attack.
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Establishing an effective communications system
Just as important as getting medicines to people is
informing people of how to protect themselves from a
biological, chemical or radiological event. As one expert has
observed, ``in disaster and emergency situations, effective
communication is . . . critical. The timely and effective flow
of information between agencies and the public is vital for
facilitating and encouraging appropriate protective actions,
reducing rumors and fear, maintaining public trust and
confidence, and reducing morbidity and mortality.''\63\
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\63\Emergency Communication and Information Issues in Terrorist
Events Involving Radioactive Materials. Steven M. Becker. Biosecurity
and Bioterrorism: Biodefense Strategy, Practice, and Science, Volume 2,
Number 3, 2004.
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To be effective and save lives, the government would need
to send these messages almost immediately after the attack and
that means the guidance should be pre-scripted to the greatest
extent possible and distribution channels should be well
established in advance. There will be no time after the
weapon's release or detonation to start drafting from scratch,
or to think for the first time about how to--or who will--
distribute the information. Unfortunately, what efforts are
underway to develop pre-scripted messages and templates in
different federal agencies are too often uncoordinated and lack
the clarity that would be needed to respond to the confusion
and panic that would follow a WMD attack.
Providing notice in advance of a spreading airborne (or
aerosol) plume of radioactive, chemical or biological materials
may provide a particularly significant opportunity to save
lives. Modeling of the spread of a nuclear plume based on real-
time wind patterns can be used to focus response and
communications efforts not only in areas that have already been
contaminated but also in those areas that will be affected in
the near future. Credible and effective communications during
an aerosol WMD attack will depend on identifying which areas
have been affected or are at risk during an attack and making
that information clearly understandable and readily
distributable to the public. The federal government generates
just such area predictions and analysis of health threats from
dangerous spreading plumes, but it currently communicates that
information in a technical manner to a limited number of
recipients.\64\ While this approach is adequate for small-scale
incidents, it would likely prove too slow during a widespread
terrorist incident affecting multiple localities or states.
During a large-scale incident, with millions of people at risk,
credible and informative products releasable by incident
commanders directly to the public will be necessary. Currently
those leading the response have to convert the federal
government's technical maps and descriptive information into a
publicly releasable form if they have the need to do so, steps
which take valuable time. As a result, getting the message out
about where the risk is and what protective steps the public
should take could be too slow to prevent significant casualties
during a large scale, fast unfolding WMD incident.
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\64\Incident commanders and other officials responding to an
aerosol event can request plume models from the DHS Interagency
Modeling and Atmospheric Assessment Center (IMAAC) located at Lawrence
Livermore National Laboratory in Livermore, California, which has been
designated as the single point for the coordination and dissemination
of Federal modeling products. The IMAAC is able to provide maps,
reports, and interpretation guides that include detailed information
such as where hospitals are located in relation to hazardous areas.
They can also generate models that delineate areas of life threatening
effects, long term effects, and areas of notable discomfort based on
criteria defined by national standards. The IMAAC also has quick access
to subject matter experts at the national labs and federal agencies.
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Tracking down the material used in a biological attack
In contrast to the production of conventional or nuclear
weapons, it is relatively easy to generate multiple biological
weapons after mastering the first due to the ability of
microorganisms to rapidly reproduce. This trait means that it
is perhaps more likely that we would face a campaign of
bioterrorist attacks, not just a single incident. As a result,
as the government grapples with the massive public health
response to a biological attack, it must simultaneously examine
the attack and weapons material in an effort to identify the
perpetrators before more attacks follow.
Bioforensics, also referred to as microbial forensics, is
defined as the scientific discipline dedicated to analyzing
evidence from a bioterrorism act, biocrime, or inadvertent
microorganism/toxin release to support ``attribution'' (i.e.,
to identify the perpetrators). Alongside traditional forensic
and investigative techniques, bioforensics can provide
information needed by law enforcement to catch a bioterrorist
group by shedding light on what pathogen is being used in the
attack, its defining characteristics, and its origin.
Unfortunately, much of the science behind the forensic analysis
of biological attacks is relatively new, having largely been
developed during the investigation of the 2001 anthrax
attacks.\65\ The Prevent WMD Commission recommended
strengthening the nation's bioforensic capability by developing
a national strategy to further the scientific field of
bioforensics, establishing a comprehensive library of pathogen
reference strains, and clearly identifying the roles and
responsibilities of federal agencies.\66\
---------------------------------------------------------------------------
\65\Bioforensics, also referred to as microbial forensics, has been
defined as the scientific discipline dedicated to analyzing evidence
from a bioterrorism act, biocrime, or inadvertent microorganism/toxin
release for attribution purposes. For a discussion of establishing the
definition and capability see Budowle et. al., ``Building Microbial
Forensics as a Response to Bioterrorism,'' Science 301, at 1852,
September 2003.
\66\World at Risk at 29.
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C.2. Title II of the WMD Prevention and Preparedness Act of 2009--
Response to a WMD Attack
Title II enhances the nation's ability to minimize mass
casualties from WMD attacks by ensuring that we will have
systems in place to get life-saving medications into victims'
hands and provide critical protective information to people in
the vicinity of an attack. This title also advances the
government's bioforensic capabilities to support attribution
and prevention of follow-on attacks.
Title II directs the Secretary of Health and Human
Services, in coordination with the Secretary of Homeland
Security and the Postmaster General, to develop a national
strategy for improving our ability to dispense medical
countermeasures (such as antibiotics needed to respond to an
anthrax attack) to individual citizens. This strategy will
describe federal agencies' roles generally and the assistance
the federal government will provide to State, local, and tribal
governments for MCM dispensing. The strategy will include a
variety of elements, such as a staffing plan, requirements for
timeliness of MCM dispensing, security, transportation, and
communications to the public regarding how to obtain MCMs. To
ensure as rapid a response as possible, the strategy is to be
tailored to local communities participating in the Cities
Readiness Initiative and representative localities of varying
geographic sizes, population densities, and demographics to
account for features unique to those communities before they
are faced with a WMD attack.\67\
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\67\While elements of MCM dispensing strategy have been captured in
the Cities Readiness Initiative, there has yet to be formulated a
comprehensive strategy that accounts for all of the critical elements
necessary to ensure an effective response, such as redundant methods of
delivery, protecting communities of differing composition, health and
liability protection of MCM dispensing providers, communications with
the public, or security of material and personnel among other key
issues.
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Title II requires a multi-pronged approach to building MCM
dispensing capability in local towns and cities. In the first
such approach, the legislation implements or expands federal
programs for disseminating MCMs after an attack and requires
the government to develop and implement a national strategy.
Title II expands an existing pilot program for using the Postal
Service to deliver MCMs to five additional cities within one
year and fifteen additional cities within two years. It is
expected that such a program could eventually be expanded to
cover the entire nation. To help reduce the burden on public
dispensing sites in the communities that host those federal
agencies and to ensure that the federal government is able to
continue critical operations in a WMD attack, Title II also
directs executive agencies to develop plans to dispense MCMs to
their employees.\68\
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\68\Since the Committee consideration of this legislation, the
Administration issued an Executive Order 13527, mandating steps
comparable to these two requirements (but not addressing the other
components of the legislation's multi-pronged strategy). Establishing
Federal Capability for the Timely Provision of Medical Countermeasures
Following a Biological Attack (December 30, 2009). The Executive Order
directs the Department of Health and Human Services (HHS) and the U.S.
Postal Service (USPS) to set up a national system using postal service
employees to dispense MCMs to homes at risk from a large-scale
biological attack. The Executive Order instructs the Secretaries of
Homeland Security and Defense, and the Attorney General to support this
effort by developing an accompanying plan to supplement local law
enforcement personnel to escort the USPS workers delivering medical
countermeasures. Additionally, the Executive Order calls for all
federal agencies to develop plans to provide MCMs to their own
employees. The Executive Order is available at http://
edocket.access.gpo.gov/2010/pdf/2010-38.pdf (Last Accessed September
30, 2010).
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Because there is no faster response available than to have
MCMs pre-positioned where they will be needed, Title II expands
the use of ``medkits,'' small packages of antibiotics--and
conceivably other medical countermeasures--that can be stored
in the home or workplace to be used in case of a WMD incident.
Use of such medkits could allow first responders to immediately
respond to an incident without additional fear of personal harm
and they also could serve to buy time for more robust, but
slower, dispensing centers to be established to handle greater
numbers of people. This legislation will place medkits in the
workplaces and homes of emergency response providers, allowing
them to react quickly to a bioterrorist event by protecting
themselves and their families from undue risk. This program,
similar to that for postal employees in the U.S. Postal Service
MCM dispensing program, would provide for the education and
health screening of first responders participating in the
program and track the proper usage of the medkits. Title II
would also authorize a large pilot study of the feasibility of
making such a program available to the general population,
something that could save valuable response time in the
aftermath of a WMD attack. The study would be larger and more
comprehensive than studies conducted previously and would
assess whether participants are properly trained on the
maintenance and use of medkits in the home.\69\
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\69\In 2006 the Centers for Disease Control and Prevention ran a
pilot program in St. Louis Missouri to assess whether participants
would correctly store and use a home medkit. The overwhelming majority
of study participants appropriately followed instructions and only used
the kit as directed by public health officials.
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Finally, Title II tasks the federal government with helping
the private sector develop its own MCM dispensing plans through
the distribution of best practices guidance. Large companies
with many employees could help reduce the burden on surrounding
communities by ensuring that their employees can access
company-based dispensing systems. Large employers often have
on-site medical personnel that would expand the number of
specialists in any given community to dispense medical
countermeasures. Moreover, with most of the nation's critical
infrastructure owned and operated by the private sector, having
an on-site dispensing capability would aid the overall response
as these facilities would continue to operate and provide
critical services.
To ensure that the population is rapidly informed of life
saving information in an effective manner, Title II also
directs the FEMA Administrator, in consultation with other
Federal, State, local, and tribal officials, to develop pre-
scripted messages and message templates that provide
information quickly to affected populations after natural
disasters, acts of terrorism, and other man-made disasters. The
bill requires the messages to be developed in multiple formats
to ensure delivery when usual communications infrastructure is
unavailable. It would also require the drafters to ensure
effective communication with individuals with disabilities or
other special needs.
Title II also ensures that in the event of a spreading
aerosol plume of radioactive, chemical or biological materials,
the federal government's modeling efforts are integrated with
guidance instructing the public about how to protect itself.
Importantly, these products are to be made available in a
publicly releasable form that the incident manager leading the
response effort can disseminate directly if the need arises.
This step ensures that the best guidance available from the
government's labs and health experts is quickly communicated to
the public, without timely conversion, while not circumventing
the centralized command structure needed to maintain an orderly
response.
As was observed during the anthrax attacks of 2001, we need
to prepare for a series of related bioterrorist attacks not
just one or two. This title authorizes a National Bioforensics
Analysis Center at DHS to serve as the lead federal facility
for technical forensic analysis following a bioattack. It
establishes a repository collection to provide samples that
will enable the advancement of bioforensic science and the
development of sample testing materials. This section also
directs the Secretary of Homeland Security to develop a
National Bioforensics Strategy laying out federal agencies'
roles in analyzing bioforensic evidence, coordination with
State, local, and tribal governments, and development of
collection standards.\70\
---------------------------------------------------------------------------
\70\Since the Committee's consideration of this legislation the
Administration has developed the U.S. National Research and Development
Strategy for Microbial Forensics (November 2009). The strategy appears
to largely meet the objectives of this legislation and includes common
elements including: coordination of Federal microbial forensics
research and practices, development of new diagnostic capabilities, and
creation of a reference national bioforensics repository collection. It
lacks an important detail, however, in that it does not clearly specify
the roles and responsibilities of the different Federal agencies, which
could lead to bureaucratic battles over leadership or to capability
gaps for which no agency claims responsibility. http://
www.whitehouse.gov/files/documents/ostp/NSTC%20Reports/
National%20MicroForensics%20R&DStrategy%202009%20UNLIMITED%20DISTRIBUTIO
N.pdf (last accessed September 30, 2010).
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D. CONFRONTING THE INTERNATIONAL BIOLOGICAL WMD THREAT
D.1. Background
Advances in biotechnology are taking place worldwide,
bringing with them great promise for advancing public health,
alternative energy production, and material manufacturing
sciences. These advances also mean that the equipment and
knowledge needed to employ biotechnology for both peaceful and
malicious intents alike are also widespread. As a result, any
efforts we take to safeguard the nation domestically must
address vulnerabilities internationally and include efforts to
secure dangerous pathogen stocks overseas, enhance foreign
disease outbreak response and preparedness capabilities, and
support international exchanges of public health and biodefense
information and experts.
The attempts by al-Qaeda and Aum Shinrikyo to develop and
deploy anthrax bioweapons underscore that the intention to
carry out bioterrorist acts exists in both well known
adversaries and in previously unrecognized threat groups. With
international travel now so widespread, an attack with an
infectious pathogen would rapidly spread across borders. As the
National Security Council has stated, ``A biological incident
that results in mass casualties anywhere in the world increases
the risk to all nations from biological threats''\71\
---------------------------------------------------------------------------
\71\National Strategy for Countering Biological Threats. National
Security Council. November 2009, at 3.
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The more developed public health systems of the U.S. and
many other developed nations give them an advantage when
mitigating the threat of both bioterrorism and infectious
disease. Effective disease surveillance systems help public
health officials respond to an outbreak of disease initiated by
terrorists the same way as they would for a pandemic influenza
outbreak. Experienced epidemiologists with access to modern
diagnostic equipment allow the ability to identify and generate
samples of the causative agent from either type of outbreak.
Unfortunately, the public health systems in developing
countries do not possess the same attributes. As a result,
there is a larger global risk, including to the U.S.,
regardless of whether the threat is natural or man-made. This
point was brought home during the 2009 H1N1 outbreak, when the
CDC had to scramble to help establish public health
laboratories, diagnostic capacity, and provide antiviral
medications in Mexico to help stem the onslaught of new cases
occurring in the U.S. as the disease spread alongside
widespread commerce and travel between the two countries. The
World Health Organization (WHO) concluded that over 60 percent
of laboratory equipment in developing countries was either
outdated or non-functioning. Further, the vast majority of
foreign national personnel were not familiar with principles of
quality assurance for handling and analyzing biological
samples. Deficiencies in training and equipment meant that many
public health units in Africa and Asia were unable to perform
accurate and timely disease surveillance.\72\
---------------------------------------------------------------------------
\72\Global Health: Challenges in Improving Infectious Disease
Surveillance Systems. United States General Accounting Office. GAO-01-
722 (August 2001), at 3.
---------------------------------------------------------------------------
The Prevent WMD Commission noted that international public
health measures, such as disease surveillance, are critical to
defending against the development and use of biological weapons
worldwide. It made numerous recommendations to facilitate broad
international involvement in support of measures for public
health and biosecurity.\73\
---------------------------------------------------------------------------
\73\World at Risk at 34-42.
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A global approach to biosecurity
There are several key international agreements and
documents that shape international efforts to contain and
counter the threat of bioterrorism. The Prevent WMD Commission
recommended renewing and strengthening these international
agreements.\74\
---------------------------------------------------------------------------
\74\Id. at 34.
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The 1972 Biological and Toxin Weapons Convention (BWC) is
the foundation of international efforts to prevent the
weaponization of biological agents and to keep them out of the
hands of terrorists.\75\ The treaty bans the development,
production and acquisition of these weapons as well as the
delivery systems to disperse such toxins. However, the BWC's
lack of a formal verification mechanism has rendered the treaty
ineffective at identifying and holding violating nations
accountable. Both the Prevent WMD Commission and the National
Strategy for Countering Biological Threats call for
revitalization of the BWC as a critical part of international
efforts to stop the proliferation of biological weapons and an
important link between global security and public health
systems.\76\
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\75\Text of the BWC and proceedings of the BWC review conferences
can be found at http://www.opbw.org/ (last accessed December 2, 2010).
\76\World at Risk at 41. National Strategy for Countering
Biological Threats. National Security Council. November 2009, at 19.
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The World Health Organization (WHO) coordinates disease
surveillance and information sharing efforts for participating
countries so that disease outbreaks can be identified and
public health responses can be launched to contain their
spread. The International Health Regulations (IHR), issued by
the WHO, legally bind the 194 signatory countries, including
all the Member States of the WHO.\77\ The IHR require countries
to report certain disease outbreaks and public health events to
the WHO. The IHR define the rights and obligations of countries
that report public health events and require countries to
strengthen their existing public health surveillance and
response capabilities. However, timeliness of reporting varies,
decreasing the effectiveness of the surveillance program.\78\
---------------------------------------------------------------------------
\77\Text of the IHRs are available at http://whqlibdoc.who.int/
publications/2008/9789241580410_eng.pdf (last accessed December 2,
2010).
\78\World at Risk at 37.
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Controls on the export of technologies or materials that
could be misused for bioterrorism are managed through an
informal assemblage of 40 countries called the Australia Group.
The Australia Group, of which the United States is a member,
maintains lists of controlled technologies and biological
pathogens that require licensing for shipping outside of the
Australia Group countries.\79\
---------------------------------------------------------------------------
\79\Report of the Working Group on Strengthening the Biosecurity of
the United States, at 10.
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Most recently, the Administration's 2009 ``National
Strategy for Countering Biological Threats'' placed a primary
focus on strengthening international public health and notes
that efforts to reduce the risk of biological threats have a
global benefit. The strategy is intended to reduce biological
threats by improving global access to tools to combat
infectious diseases; establish and reinforce standards to
discourage the misuse of the life sciences; and institute a
series of activities to help influence, identify, inhibit and
interdict those who seek to harm others through the misuse of
life sciences.\80\
---------------------------------------------------------------------------
\80\National Strategy for Countering Biological Threats. National
Security Council. November 2009, at 3.
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D.2. Title III of the WMD Prevention and Preparedness Act of 2009--
International Measures to Prevent Biological Terrorism
Title III of the WMD Prevention and Preparedness Act
strengthens efforts to prevent the international proliferation
of biological weapons. It encourages the United States to
collaborate with other countries to improve cross-border and
internal biosecurity efforts and includes provisions to improve
global surveillance of dangerous agents. It fosters critical
partnerships with foreign public health systems that would be
necessary to share samples, provide surge response forces, and
assist in identifying the origin of an attack or pandemic.
Subtitle A provides for the prevention and protection
against international biological threats. It requires the
Director of National Intelligence to assess the international
threats, and directs the Secretary of State to work with
countries to raise awareness of biological threats
internationally and assist those countries deemed a high
priority with mitigating threats. The Secretary will also
develop a strategy to ensure that international agreements
regarding WMDs are widely adhered to and to create safeguards
to prevent the misuse of biotechnology.
Subtitle B, the ``Global Pathogen Surveillance Act of
2009'', seeks to enhance the international community's ability
to detect, identify, and contain infectious disease outbreaks,
whether the cause of those outbreaks is intentional or natural
in origin.\81\ Its objective is to expand U.S. assistance to
developing nations in the following areas: the training of
public health personnel in epidemiology, particularly the
diagnosis and containment of likely bioterrorism agents; the
acquisition of laboratory and diagnostic equipment; the
acquisition of communications technology allowing for the rapid
dissemination of data regarding disease patterns and pathogen
diagnoses to public health authorities and international
entities; the expansion of facilities overseas by the CDC and
the Department of Defense to conduct research and disease
surveillance, with the approval of the host country; and,
expanded assistance to the WHO and other regional disease
surveillance efforts.
---------------------------------------------------------------------------
\81\The Global Pathogen Surveillance Act of 2009 is derived from
similarly titled bills drafted by the Senate Foreign Relations
Committee and passed by that Committee in 2008, 2007, 2005, 2004, 2003,
and 2002 and by the full Senate in 2005 and 2002.
---------------------------------------------------------------------------
Subtitle C of Title III strengthens the ability of the
United States to confront the threats of nuclear
nonproliferation. This subtitle requires the President's
Coordinator for the Prevention of WMD Proliferation and
Terrorism, established in the Implementing Recommendations of
the 9/11 Commission Act, to make an annual report on U.S.
nonproliferation efforts and the U.S. nonproliferation efforts
in working with the International Atomic Energy Agency
(IAEA).\82\ It specifically addresses a series of findings and
recommendations from the Prevent WMD Commission regarding the
revitalization of the Nuclear Nonproliferation Treaty (NPT).
Over time, the nonproliferation regime in the NPT has eroded
and the International Atomic Energy Agency's financial
resources have fallen far short of what is required to fulfill
its expanding mandate.\83\
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\82\The President's Coordinator for the Prevention of WMD
Proliferation and Terrorism was established under section 1841 of the
Implementing Recommendations of the 9/11 Commission Act, P.L. 110-53,
121 Stat. 498, 50 U.S.C. Sec. 2931 (2007).
\83\World at Risk at 46.
---------------------------------------------------------------------------
Subtitle D of Title III would implement Title V of the
Nuclear Non-Proliferation Act of 1978 (Public Law 95-242),
which requires greater U.S. assistance in establishing non-
nuclear, alternative energy sources in developing countries.
This would implement a key recommendation of the Prevent WMD
Commission's World at Risk report.\84\ The Secretary of Energy,
in cooperation with the Secretary of State and the
Administrator of the United States Agency for International
Development, would be required to establish strategic and
implementation plans for the energy development program
established under Title V of the Nuclear Non-Proliferation Act.
The Secretary of Energy would be required to report annually on
the efforts and commitments under this program and consider the
feasibility of expanding cooperative activities to include a
volunteer Alternative Energy Corps.
---------------------------------------------------------------------------
\84\Id. at 51.
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E. ORGANIZING GOVERNMENT TO RESPOND EFFECTIVELY
E.1. Background
The Prevent WMD Commission identified three key areas in
which government organization should be improved in order to
strengthen the U.S. Government's capacity to prevent and
prepare for a WMD attack. The first two areas pertain to U.S.
intelligence capabilities, while the third relates to advice
provided to Congress concerning counterterrorism technology.
With respect to intelligence, the WMD Commission stated
that ``praise is warranted to Congress for its efforts to push
intelligence community reforms'' beginning with the
Intelligence Reform and Terrorism Prevention Act of 2004 and to
agencies for their subsequent work including initiatives at the
National Counterterrorism Center, the DNI's 500 Day Plan for
Intelligence Community reform, and the revision to the
cornerstone of the Intelligence Community's regulatory
structure, Executive Order 12333. However, the Commission found
that the number and diversity of WMD-related targets are
increasing and that (1) such targets are especially challenging
for traditional collection techniques and (2) intelligence
analysts lack the requisite scientific and technical expertise.
The Commission also noted that engagement with outside experts
is particularly important in the biological area because of the
speed of advancements. Finally, the Commission noted that the
increase in the number of codeword compartments--an additional
restriction placed on top secret information to further limit
the number of people with access to it--in the Intelligence
Community for WMD-related intelligence hinders information-
sharing. Accordingly, the Commission recommended that the
Intelligence Community prioritize efforts to collect and
analyze intelligence related to the nexus of WMD and terrorism,
with an emphasis on recruiting employees with scientific and
technical expertise and ensuring information-sharing.\85\
---------------------------------------------------------------------------
\85\Id. at 99.
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Also with respect to intelligence, the WMD Commission found
that human intelligence collection requires that intelligence
personnel have the necessary language skills and ethnic and
cultural backgrounds to gain access to communities in which
terrorists operate. The Commission noted that significant
strides have been made to recruit individuals with such skills,
including adoption of the Intelligence Community's Foreign
Language Strategic Program in 2003 and gains in language
capabilities made by the Central Intelligence Agency. However,
the Commission found that the Intelligence Community is still
deficient in this area and recommended that the Intelligence
Community accelerate its recruitment and retention efforts,
with a focus on clearing any security clearances barriers.\86\
---------------------------------------------------------------------------
\86\Id. at 99.
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In addition, the Commission found that the
interdisciplinary nature of WMD and counterterrorism issues
cuts across relevant Congressional committees' jurisdiction.
Moreover, the Commission recommended that Congress strengthen
its oversight and legislative functions by consulting closely
with experts versed in relevant scientific and technical
disciplines. Accordingly, the Commission recommended that
Congress create an office in the Legislative Branch to serve as
the repository of counterterrorism scientific and technical
knowledge in order to advise Members and Committees.
E.2. Title IV of the WMD Prevention and Preparedness Act of 2009--
Government Organization
Title IV implements the Commission's recommendations to
improve Intelligence Community capabilities concerning WMD and
terrorism. Title IV requires the DNI to adopt a strategy to
improve the Intelligence Community's performance regarding WMD
intelligence. Specifically, this strategy should include hiring
scientists, collaborating with nongovernmental experts,
developing innovative collection techniques against countries
and transnational actors such as criminal enterprises, and
improving information-sharing. Title IV also requires the DNI
to develop a strategy for recruiting employees with critical
language skills and cultural backgrounds relevant to
counterterrorism based on predicted needs over a ten-year time
frame. Among other things, that strategy should remedy security
clearance barriers to recruitment of such individuals.
Title IV ensures that each of these two strategies will be
systematic and articulate a measurable course of action. Title
IV mandates that each strategy contain five process elements,
including prioritized objectives and a schedule for meeting
them; assignment of roles and responsibilities in the
Intelligence Community; a description of the personnel and
financial resources necessary to implement the strategy;
metrics to measure efficiency and effectiveness; and a schedule
for assessing the strategy.
Finally, Title IV implements the Commission's
recommendation to strengthen the science and technical advisory
capabilities available to Congress. Title IV uses a three-
tiered approach--utilizing existing organizations rather than
creating an expensive new Legislative Branch office--to provide
Congress with assessments of technology and technological
applications relevant to counterterrorism. First, Title IV
requires the Congressional Research Service (CRS) to establish
an interdisciplinary capability in order to be able to
supplement the advice that CRS normally provides to Congress
with advice concerning counterterrorism technology and
technological applications. Second, Title IV requires the
Government Accountability Office (GAO) to form its own
interdisciplinary capability to conduct assessments of
counterterrorism technology or technological applications to
include their actual or anticipated impact, effectiveness, or
efficiency as well as any test results, technological
alternatives, actual and anticipated costs and benefits, and
actual or anticipated countermeasures. Third, Title IV
authorizes GAO to contract with the National Academy of
Sciences to provide long-range assessments of counterterrorism
technological trends and gaps as well as advice concerning
needed investments. Title IV authorizes $2 million per year for
each fiscal year 2011-2013 for each of CRS, GAO, and GAO's
funding of related studies by the National Academy of Sciences.
F. EMPOWERING CITIZENS AND COMMUNITIES IN THE RESPONSE
F.1. Background
The first person on the scene of an incident to help those
in need is not likely to be a federal strike team member or
even a local emergency response provider, but rather a neighbor
or co-worker who will provide assistance in those critical
first few moments. Local first responders will next be
responsible for shouldering most of the burden of the response
alone from the first hours through the beginning days of the
response and likely will provide the bulk of the response
during the entire incident. While some federal response
providers likely will arrive on scene in the first day of a
catastrophic incident, several days will likely pass before
significant federal capabilities arrive. In short, logistical
realities suggest that individual citizens and communities will
form the cornerstone of any response effort.
The Prevent WMD Commission appropriately stressed the
criticality of citizens' roles in preventing and responding to
terrorism involving WMD. As the Commission noted, ``A well-
informed and mobilized citizenry has long been one of the
United States' greatest resources.''\87\ To that end, the
Commission recommended increasing public education concerning
the nature of WMD and terrorism threats, what they should
expect from the government in the event of a crisis, and what
advance preparations and actions they should take.
---------------------------------------------------------------------------
\87\World at Risk at 108.
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F.2. Title V of the WMD Prevention and Preparedness Act of 2009--
Emergency Management and Citizen Engagement
Title V seeks to strengthen citizen involvement and
preparedness by requiring that the government practice greater
openness of public information. Title V requires the Secretary
of Homeland Security, in coordination with the Attorney
General, to provide unclassified terrorism-related threat and
risk assessments to the public on a timely basis. These
assessments should include guidelines for the public to prevent
and respond to terrorism. The title also requires the Secretary
of Homeland Security to provide guidelines to State, local, and
tribal governments on disseminating information concerning
terrorism threats and risks to the public.
In this vein, Title V amends section 201 of the Homeland
Security Act of 2002, as amended, which institutes the Homeland
Security Advisory System, to ensure that the Secretary provides
information to the public for deterring and responding to
terrorism. The Committee has had long-standing concerns
regarding DHS's implementation of the Homeland Security
Advisory System. Due to these concerns, Title V requires that
DHS submit a report to the Senate Homeland Security and
Governmental Affairs Committee and the House Homeland Security
Committee within 180 days of the enactment of this bill on
implementation of the Homeland Security Advisory System.
Title V provides emergency response providers with the
guidance they need to protect themselves and the citizens of
their community during a WMD incident. An explosion or release
of nuclear, biological, radiological, or chemical material will
pose unique challenges to first responders if the expertise to
deal with the incident safely and effectively lies outside of
the affected local community. Title V ensures that the
expertise that exists in emergency response organizations, in
different communities across the nation, and in our national
labs and federal agencies is put to use to develop best
practices and guidelines for use in any community during an
incident before we are faced with such an attack. The
guidelines compiled or developed pursuant to Title V will
provide descriptive information on the effects of different WMD
threats and recommendations for protective actions to ensure
the health and safety of emergency response providers. They
will also address how emergency response providers and mass
care facilities can care for citizens affected by the incident
who may have needs unique to the threat, such as radioactive or
biological contamination. The title requires the Secretary of
Homeland Security to evaluate current guidance documents
generated by nongovernmental organizations or government
agencies for their applicability to this purpose and to
identify gaps where new guidance needs to be developed. This
guidance is to be updated regularly to capture the best
practices in the field as it evolves.
Of course, a rapid response relies on strong communities
and the preparedness organizations that provide the first
responders on the scene. Title V assists communities in
identifying their preparedness capabilities and gaps through
the development of guidance documents and checklists. It
fosters outreach efforts to communities and individuals to
provide information and training to all hazard threats. It also
provides for support of voluntary community preparedness
programs, such as the Community Emergency Response Teams, Fire
Corps, Medical Reserve Corps, Volunteers in Police Service,
USAonWatch-Neighborhood Watch, and other voluntary programs. It
authorizes the FEMA Administrator to provide $15 million in
such grants in FY2011 and $20 million in each of FY2012 and
FY2013.
III. Legislative History
Chairman Lieberman and Ranking Member Collins introduced S.
1649 on September 8, 2009. The bill was read twice and referred
to the Committee on Homeland Security and Governmental Affairs.
Senators McCaskill, Robert Bennett (UT), and Michael Bennet
(CO) subsequently joined as cosponsors.
The Committee held a hearing to discuss the bill on
September 22, 2009, entitled ``World At Risk: The Weapons of
Mass Destruction Prevention and Preparedness Act of 2009.''\88\
Witnesses included: The Honorable Bob Graham, Chairman, and The
Honorable Jim Talent, Vice Chairman, of the Commission on the
Prevention of Weapons of Mass Destruction Proliferation and
Terrorism, and Gregory D. Kutz, Managing Director of Forensic
Audits and Special Investigations, U.S. Government
Accountability Office. At the hearing, former Senators Graham
and Talent called for passage of S. 1649 to fulfill many of the
recommendations contained in their report. Gregory Kutz
testified on the limited improvement that laboratories designed
to handle the most dangerous pathogens had made in improving
their external physical security since the GAO's initial report
(GAO-08-1092, GAO-09-851).\89\
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\88\The Committee had previously heard from the Commission's Chair
and Vice-Chair, as well as other Commission members during a hearing on
December 11, 2008, entitled ``World at Risk: A Report from the
Commission on the Prevention of Weapons of Mass Destruction
Proliferation and Terrorism.'' The Commission members' testimony
regarding their findings and recommendations significantly informed the
drafting of S. 1649.
\89\This legislation also responds to this Committee's own analysis
of the threat of bioterrorism. Committee staff conducted extensive
outreach to numerous scientific organizations and all relevant federal
agencies prior to drafting this legislation in order to examine the
issue of biosecurity and WMD preparedness--and subsequently to review
and refine drafts of the legislation. Committee staff met or consulted
with, for example, representatives of the American Association for the
Advancement of Science, the American Society for Microbiology, the
Federation of American Societies for Experimental Biology, the
Biotechnology Industry Organization, the American Biological Safety
Association, Galveston National Laboratory, the Center for Biosecurity,
the International Association of Fire Chiefs, and numerous private
companies among others.
The Committee has also conducted extensive oversight and
investigative work--under the leadership of chairmen from both
parties--concerning U.S. counterterrorism performance and the WMD
threat since September 11, 2001. Among its numerous hearings concerning
the threat of global terrorism to the homeland, the Committee has held
a series of hearings on the danger of nuclear terrorism and our
preparedness for a possible nuclear terrorist attack. These hearings
were the result of an investigation into U.S. preparedness for and
defenses against nuclear terrorism, involving numerous briefings from
and interviews with key Executive Branch personnel across the
Departments of Homeland Security, Energy, and Defense. See hearings
before the Senate Committee on Homeland Security and Governmental
Affairs, e.g., Nuclear Terrorism: Assessing the Threat to the Homeland,
April 2, 2008; Nuclear Terrorism: Confronting the Challenges of the Day
After, April 15, 2008; Nuclear Terrorism: Providing Medical Care and
Meeting Basic Needs in the Aftermath, May 15, 2008; Nuclear Terrorism:
Providing Medical Care and Meeting Basic Needs in the Aftermath--The
Federal Response, June 26, 2008; The Global Nuclear Detection
Architecture: Are We Building Domestic Defenses That Will Make the
Nation Safer?, July 16, 2008; Preventing Nuclear Terrorism: Hard
Lessons Learned From Troubled Investments, September 25, 2008; Nuclear
Terrorism: Strengthening Our Domestic Defenses, Part I, June 30, 2010;
and Nuclear Terrorism: Strengthening Our Domestic Defenses, Part II,
September 15, 2010. The Committee has also conducted oversight and
hearings concerning our preparedness for a pandemic, whether naturally
occurring or the result of a biological attack. See hearings before the
Senate Committee on Homeland Security and Governmental Affairs, e.g.,
Six Years After Anthrax: Are We Better Prepared to Respond to
Bioterrorism?, October 23, 2007; Swine Flu: Coordinating the Federal
Response, April 29, 2009; H1N1 Flu: Protecting Our Community, September
21, 2009; H1N1 Flu: Monitoring the Nation's Response, October 21, 2009;
and H1N1 Flu: Getting the Vaccine to Where It Is Most Needed, November
21, 2009.
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The Committee considered S. 1649 on October 28, 2009 and
November 4, 2009, and adopted several amendments by voice vote:
Lieberman-Collins substitute amendment that
clarified the stratification of the Select Agent Program into
three tiers, contained provisions to clarify the roles for
agencies, and required increased interagency coordination--
including references to the Secretary of Defense and other
Cabinet secretaries, clarified numerous definitions, lowered
authorization amounts in several sections, and made numerous
technical changes. Senators present were Lieberman, Levin,
Akaka, Pryor, McCaskill, Collins, Voinovich, and Graham.
An Akaka amendment requiring the Secretary of
Energy to provide implementation plans for an Energy
Development Program to support the development of non-nuclear,
alternative energy sources in developing nations and strengthen
international efforts to prevent nuclear proliferation
consistent with Title V of the Nuclear Non-Proliferation Act of
1978. Senators present were Lieberman, Levin, Akaka, Pryor,
Collins, and Graham.
An Akaka amendment, as modified, requiring reports
on U.S. nuclear nonproliferation efforts and on U.S.
involvement with the International Atomic Energy Agency.
Senators present were Lieberman, Levin, Akaka, Pryor, Collins,
and Graham.
A McCaskill amendment authorizing the Secretary of
Homeland Security to suspend research at any lab found to have
violated the department's biosecurity regulations governing the
most lethal (Tier I) agents, if the violations endangered
security, until the violation has been remedied. Senators
present were Lieberman, Levin, Akaka, Pryor, McCaskill,
Collins, and Graham.
A Graham amendment, as modified, directing HHS, in
coordination with DHS, to promulgate regulations on handling
portions of smallpox DNA (known scientifically as Variola
virus). Senators present were Lieberman, Levin, Akaka, Pryor,
Collins, and Graham.
A Graham amendment requiring the National
Academies' Institute of Medicine to conduct a study of the
feasibility of supplying medical countermeasures from the
Strategic National Stockpile that are about to expire to first
responders. Senators present were Lieberman, Levin, Akaka,
Pryor, Collins, and Graham.
The Committee ordered the bill, as amended, reported
favorably on November 4, 2009 by a roll call vote of 8-1.
Senators Lieberman, Akaka, Carper, Pryor, Landrieu, Burris,
Collins, and Bennett (UT) voted in favor of the bill, while
Senator Levin voted against it. Senators McCaskill, Tester,
Kirk, and Graham asked to be recorded in favor of the bill by
proxy, while Senators Coburn and Voinovich asked to be recorded
against the bill by proxy.
IV. Section-by-Section Analysis
Section 1. Short title; and table of contents
This section gives the bill the short title of the
``Weapons of Mass Destruction Prevention and Preparedness Act
of 2009'' or the ``WMD Prevention and Preparedness Act of
2009'' and provides its table of contents.
Title I--Enhanced Biosecurity
Section 101. Designation of Tier 1 agents
This section amends the sections of the Public Health
Service Act and the Agriculture Bioterrorism Protection Act of
2002 that established the Select Agent Program. The Secretaries
of Health and Human Services and Agriculture are directed to
establish a Tier I designation for the small number of select
agents with clear potential to be used effectively in a
biological attack and that could cause significant human
casualties or catastrophic agricultural consequences. The
creation of a Tier I category allows for the directed
application of enhanced security measures promulgated pursuant
to the section 102.
Subsection 101(a) amends section 351A of the Public Health
Service Act (42 U.S.C. Sec. 262a) to direct the Secretary of
Health and Human Services, in coordination with the Secretary
of Homeland Security, to designate by rule ``Tier 1 agents.''
The provision directs the secretaries to consider several
criteria in designating biological agents and toxins as Tier 1
agents, including whether the Secretary of Homeland Security
has issued a Material Threat Determination regarding the agent
or toxin, relevant biological risk assessments conducted by DHS
or other agencies and whether the agent or toxin has the clear
potential to be used effectively in a biological attack that
causes significant casualties. The list of Tier 1 agents is to
be reviewed at least biennially.
Subsection 101(b) amends section 212(a) of the Agricultural
Bioterrorism Protection Act of 2002 (7 U.S.C. Sec. 8401(a))
regarding the designation of agricultural ``Tier 1 agents'' in
an analogous manner to that done for human health ``Tier 1
agents'' in section 101(a). The Secretary of Agriculture, in
coordination with the Secretary of Homeland Security is to
designate by rule ``Tier 1 agents''. Several criteria will be
considered in designating biological agents and toxins as Tier
1 agents including issuance of a Material Threat Determination
regarding the agent or toxin by the Secretary of Homeland
Security, relevant biological risk assessments conducted by DHS
or other agencies, and whether the agent or toxin has the clear
potential to be used effectively in a biological attack that
causes catastrophic consequences. The list of Tier 1 agents is
to be reviewed at least biennially.
Section 102. Enhanced biosecurity measures
This section enhances the biosecurity standards for
laboratories handling Tier I agents while leaving the other
aspects of the current Select Agent Program, such as biosafety,
in effect as they exist today. The provision sets forth
categories of security protections that should be considered--
including staff training, personnel reliability, laboratory
risk assessments, risk based laboratory security performance
standards--but does not prescribe what those security standards
should be. Instead, this section creates the framework for the
development of such standards by DHS through a process with
maximum participation of government and nongovernmental
stakeholders.
Specifically, this section directs the Secretary of
Homeland Security, in consultation with the Secretaries of
Health and Human Services and Agriculture, to establish Tier I
biosecurity standards through a negotiated rule-making. In a
negotiated rule-making, a committee of relevant parties is
assembled to seek to produce a consensus recommendation to the
Secretary of Homeland Security. This committee will include
Federal agencies, academic and private research institutions,
and other key stakeholders. The committee would make
recommendations to the Secretary within six months of the
bill's enactment, and the Secretary would promulgate a final
rule within a year. The provision directs the negotiated
rulemaking committee and the Secretary to consider the full
spectrum of views, reports and recommendations of recent
scientific and interagency working groups, and how to minimize
disincentives posed by security standards to biological
research.
The Secretary of Homeland Security, in consultation with
the Secretaries of Health and Human Services and Agriculture,
would enforce the regulations promulgated under this section.
Training programs, which will be broadly applicable across both
biosecurity and biosafety concerns, are to be developed or
approved by the Secretary of Health and Human Services. This
section provides for civil penalties for violations of the
regulations, as well as for intermediate sanctions for
correcting lesser deficiencies in lieu of civil penalties.
To minimize the financial and administrative burden on
laboratories subject to often redundant inspections by multiple
agencies, this section requires that all inspections related to
Tier I or select agent regulations by a regulatory agency or an
agency evaluating biosecurity measures pursuant to a
contractual obligation shall, to the extent practicable, be
conducted simultaneously and with harmonized procedures. This
section also directs that agencies inspecting for regulatory or
contractual purposes share their reports with other agencies
with a regulatory or contractual interest in order to reduce
redundant inspections that arise for lack of access to
inspection results from another Federal agency. These measures
intend to foster a unified Federal inspection team and keep
agencies from imposing conflicting demands on an evaluated
laboratory.
Subsection 102(a) provides definitions for this section.
``Listed agents'' are those biological agents or toxins that
populate the current select agent list and are defined by
inclusion on the list established and maintained by the
Secretary of Health and Human Services under section 351A(a)(1)
of the Public Health Service Act (42 U.S.C. Sec. 262a(a)(1));
or the list established and maintained by the Secretary of
Agriculture under section 212(a)(1) of the Agricultural
Bioterrorism Protection Act of 2002 (7 U.S.C. Sec. 8401(a)(1)).
The term ``person'' has the meaning given that term in section
351A(l)(6) of the Public Health Service Act (42 U.S.C.
Sec. 262a(l)(6)) and includes individuals or entities seeking
to access select agents, including Federal, State, and local
governmental and private entities. The term ``Tier 1 agent''
has the meaning given to it in section 101 of this Act.
Subsection 102(b) mandates a negotiated rulemaking through
which the Secretary of Homeland Security, in consultation with
the Secretary of Health and Human Services and the Secretary of
Agriculture, establishes enhanced biosecurity measures for
persons that possess, use, or transfer Tier 1 agents. It
requires rules addressing standards for (1) personnel
reliability programs, (2) biosecurity training of people
involved in the use of Tier 1 agents, (3) performing laboratory
risk assessments, (4) risk based performance measures for
laboratory security, and (5) any other security standards
determined necessary jointly by the Secretaries of Homeland
Security and Health and Human Services.
Subsection 102(c) lists those to be included in the
negotiated rulemaking committee and includes representatives
from several federal agencies and from the regulated community.
Subsection 102(d) provides a deadline of 6 months from the
date of this legislation's enactment for the negotiated
rulemaking committee to provide its recommendations and 1 year
from enactment for the promulgation of a final rule.
Subsection 102(e) directs the Secretary and the negotiated
rulemaking committee to consider reports from several
identified federally mandated commissions and advisory boards
and how any disincentives to biological research arising from
the enhanced biosecurity measures can be minimized.
Subsection 102(f) describes how the enhanced biosecurity
measures should be implemented. It directs the Secretary of
Homeland Security, in consultation with the Secretaries of
Health and Human Services and Agriculture, to enforce the
enhanced biosecurity standards promulgated under this section.
The Secretary of Health and Human Services, in consultation
with the Secretary of Homeland Security, is to develop or
approve training programs that meet the standards promulgated
under this section. This subsection directs that regulations
under the current select agent security regime promulgated
under section 351A(b)(1) of the Public Health Service Act (42
U.S.C. Sec. 262a(b)(1)) or under section 212(b)(1) of the
Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C.
Sec. 8401(b)(1)) shall be amended when they conflict with the
regulations promulgated under this section. This subsection
provides for penalties for non-compliance with the enhanced
biosecurity measures, including civil monetary penalties,
suspension of research, or intermediate sanctions such as
issuance of corrective action plans and onsite monitoring.
To bring efficiency to the oversight of biological select
agent and toxin research, subsection 102(f) directs agencies
reviewing a BSAT research institution for regulatory or
contractual compliance with the BSAT regulations to carry out
those reviews jointly to the extent practicable. In order to
reduce divergent or conflicting expectations amongst federal
agencies on how to comply with the BSAT regulations, agencies
are expected to ensure that inspection procedures are
coordinated and mutually agreed to beforehand. Finally, to
reduce the need for agencies to conduct redundant inspections
simply for lack of access to inspection results from another
agency, this title requires that agencies inspecting for
regulatory or contractual compliance share their reports with
other agencies that have a vested interest in the inspected
facility. This subsection also authorizes to be appropriated
such sums as may be necessary to carry out this section and
provides for technical and conforming amendments to the
Homeland Security Act of 2002 (6 U.S.C. Sec. 101 et seq.).
Section 103. Laboratory and facility registration and database
This section requires the Secretary of Health and Human
Services, in coordination with the Secretaries of Homeland
Security and Agriculture, to mandate the registration of
laboratories that (1) have characteristics that could
facilitate the misuse of a laboratory for the purposes of
developing a biological weapon, or (2) that work on agents
posing a severe threat to public health. The registration of
laboratories is intended to provide the government with
awareness as to their location and facilitate the distribution
of biosafety and biosecurity best practices.
The current lists of select agents include many agents that
could not be used effectively in developing a biological
weapon. This situation arises in part because the statutory
provisions governing the designation of select agents do not
require the Secretaries of Health and Human Services or
Agriculture to consider the suitability of the agent for use in
a biological weapon or any other biosecurity factor when
designating agents as select agents. The section encourages the
removal from the select agent list of those agents that would
not be suitable for use as a biological weapon, thus furthering
the stratification of agents, ensuring that security
regulations are commensurate with the risk posed by the agent,
and reducing the overall burden of the security regulatory
regime on laboratories. It is expected that the list of
Registry Agents would likely consist primarily of agents
removed from the select agent list but also include emerging
threats for which the severity of the threat is still being
evaluated. Laboratories and persons possessing Registry Agents
would be required to register with the Secretary of Health and
Human Services but would not otherwise be subject to
biosecurity regulations.
Subsection 103(a) amends section 351A of the Public Health
Service Act (42 U.S.C. Sec. 262a) by inserting a new subsection
``(f) Laboratory and Facility Registration and Database.''
Subsection ``351A(f)(1)'' directs the Secretary of Health and
Human Services to issue a regulation establishing criteria for
defining which laboratories would be subject to registration
requirements, with a focus on laboratories with features that
could be useful in developing a biological weapon, such as the
synthesis of Tier 1 agents, or which would enable an individual
to develop a biological weapon while escaping detection.
Subsection ``351A(f)(2)'' directs the Secretary of Health and
Human Services to establish by regulation a designation of
``Registry Agents'' which are to encompass those biological
agents and toxins which have the potential to pose a severe
threat to public, animal, or plant health but for which the
potential to be used in a biological attack has not been
established. These agents do not pose as significant or as
clear of a threat as do select agents or Tier 1 select agents.
Subsection ``351A(f)(3)'' requires the Secretary of Health and
Human Services to register persons or facilities regulated
pursuant to Subsections ``351A(f)(1)'' and ``351A(f)(2)'' and
to establish a database of those persons or facilities.
Subsection ``351A(f)(4)'' provides for civil monetary penalties
for persons violating any rules promulgated pursuant to this
section. Subsection ``351A(f)(5)'' describes which federal
entities shall have access to the database established under
subsection ``351A(f)(3).'' Subsection ``351A(f)(6)'' directs
the Secretary of Health and Human Services to promote
biosecurity and biosafety best practices to persons registered
under this section. Subsection ``351A(f)(7)'' protects against
inappropriate disclosure of sensitive information.
Subsection 103(b) directs the Secretaries of Health and
Human Services and Agriculture to conduct a comprehensive
review of the list of biological agents and toxins on the
select agent list to determine which would more appropriately
meet the criteria of the ``registry agent'' category. It also
amends section 351A of the Public Health Service Act (42 U.S.C.
Sec. 262a) and section 212(a) of the Agricultural Bioterrorism
Protection Act of 2002 (7 U.S.C. Sec. 8401(a)) to include
consideration of the suitability of the agent to be used in a
biological attack in the criterion for designating select
agents. This subsection also exempts clinical or diagnostic
laboratories that may come into transitory possession of
registry agents from having to register with the Secretary of
Health and Human Services and is consistent with the exemptions
for these entities currently in place for the Select Agent
Program.
Subsection 103(c) authorizes such sums as may be necessary
to carry out this section. Subsection 103(d) makes conforming
amendments.
Section 104. Background checks
This section directs the Attorney General, when conducting
a background check on individuals seeking access to select
agents, to consult with the Secretary of Homeland Security to
determine whether there is reason to believe that those
individuals have knowing involvement with a terrorist
organization. Current DOJ background checks do not generally
include a review of all relevant intelligence in the hands of
other government agencies. Consultation with the Department of
Homeland Security could provide important information to the
Department of Justice concerning an applying individual's
possible terrorist ties, particularly as it relates to any
contacts of concern in foreign settings.
Section 105. Biological laboratory protection
This section provides resources that are intended to reduce
the burden that laboratories conducting Tier 1 select agent
research carry by providing financial assistance to meet the
enhanced security measures promulgated pursuant to section 102.
This section also provides all select agent laboratories
greater access to the expertise of the Department of Homeland
Security through participation in the department's confidential
and voluntary vulnerability assessment program, the costs of
which are carried by the department.
Subsection 105(a) authorizes the Secretary of Homeland
Security to award $50 million in grants for each of fiscal
years 2011-2014 to academic and nonprofit organizations and
State, local, and tribal governments to improve security at
laboratories that handle Tier I agents.
Subsection 105(b) directs the Secretary of Homeland
Security to encourage laboratories currently handling agents
listed under the Select Agent Program to undergo voluntary DHS
vulnerability assessments.
Section 106. Biosecurity information sharing
This section directs the Secretary of Homeland Security to
ensure that State, local, and tribal governments have access to
relevant safety and security information concerning biological
laboratories in or near their jurisdictions, consistent with
classified or sensitive information provisions and privacy
laws. In doing so, the Secretary of Homeland Security may
utilize information from the national databases maintained by
HHS and USDA pursuant to the Select Agent Program.
Subsection 106(a) amends section 351A(d) of the Public
Health Service Act (42 U.S.C. Sec. 262a(d)) to provide access
to the database of persons with access to select agents to the
Attorney General, the Secretaries of Agriculture, Homeland
Security, Energy, Defense, and other federal secretaries as the
Secretary of Health and Human Services determines appropriate.
Subsection 106(b) amends section 212(d) of the Agricultural
Bioterrorism Protection Act of 2002 (7 U.S.C. Sec. 8401(d)) to
provide access to the database of persons with access to select
agents to the Attorney General, the Secretaries of Health and
Human Services, Homeland Security, Energy, Defense, and other
federal secretaries as the Secretary of Agriculture determines
appropriate.
Subsection 106(c) directs the Secretary of Homeland
Security to ensure that State, local, and tribal governments
have access to relevant safety and security information
relating to biological laboratories and facilities in their
jurisdictions, as the Secretary determines appropriate. In
carrying out this directive the Secretary is authorized to use
data from databases to which the Secretary is provided access
in subsections 106(a) and 106(b). The Secretary is to ensure
that classified and sensitive safety and security information,
or information that is subject to privacy regulations, is
appropriately protected.
Subsection 106(d) makes technical and conforming
amendments.
Section 107. Research with the Variola virus genome
This section directs the Secretary of Health and Human
Services, in coordination with the Secretary of Homeland
Security, to promulgate regulations on handling portions of the
DNA of the Variola virus, the causative agent of smallpox.
Possession of the entire smallpox virus genome is currently
regulated under the Select Agent Program, but those regulations
do not restrict possession of portions of its DNA, which can be
very useful in research. These fragments of the virus genome do
not pose a biological weapons or public health threat because
the existing state of biotechnology does not enable those
portions to be reassembled into a fully functioning infectious
smallpox virus. The rapid advancement of biological sciences,
however, means that scientists may well soon be able to
accomplish just such a feat. The World Health Organization has
issued non-binding recommendations on how nations should handle
this research. This section directs the Secretary of Health and
Human Services to develop binding regulations and to consider
the World Health Organization recommendations when doing so.
Subsection 107(a) directs the Secretary of Health and Human
Services to promulgate regulations governing the distribution,
synthesis, and handling of Variola virus DNA.
Subsection 107(b) provides certain considerations that
should be taken into account, including the World Health
Organization recommendations of May 2008 on the distribution,
synthesis, and handling of Variola virus DNA, as well as the
continuing importance of legitimate research on components of
Variola virus DNA for public health purposes.
Subsection 107(c) directs the promulgated rules to address
which entities are qualified to handle research with Variola
virus DNA, limits on the distribution and synthesis of Variola
virus DNA, and the total size of the Variola virus genome that
can be possessed.
Title II--Response to a Weapon of Mass Destruction Attack
Subtitle A--Ensuring Access to Medical Countermeasures During
Emergencies
Section 201. National Medical Countermeasures Dispensing Strategy
This section requires the Secretary of Health and Human
Services, in coordination with the Secretary of Homeland
Security and the Postmaster General, to develop a National
Medical Countermeasure Dispensing Strategy. This strategy is
focused on improving our ability to dispense medical
countermeasures--such as antibiotics needed to respond to an
anthrax attack--to individual citizens from staging and storage
areas. Plans are currently in place for sending medical
countermeasures to staging and storage areas from national
stockpiles but there has been insufficient planning for
distributing countermeasures the ``last mile.'' This strategy
will describe federal agencies' roles generally and outline the
assistance federal agencies will make available to State,
local, and tribal governments for medical countermeasure
dispensing. The strategy will reflect that no single dispensing
method is likely to be sufficient for every community or for
the duration of an incident. As such, the strategy will include
measures to support a variety of approaches that will be
layered to address the response needs of a community as the
incident unfolds.
This section amends Title III of the Public Health Service
Act (42 U.S.C. Sec. Sec. 241 et seq.) to insert a new section
``319N. National Medical Countermeasure Dispensing Strategy.''
Subsection ``319N(a)'' provides for definitions used in
this section.
Subsection ``319(b)'' directs the Secretary of Health and
Human Services, in coordination with the Secretary of Homeland
Security and Postmaster General, to develop, coordinate, and
maintain a National Medical Countermeasure Strategy.
Subsection ``319(c)'' describes the content of the strategy
and directs the strategy to include: descriptions of the
federal role in dispensing medical countermeasures, how diverse
population centers will be covered, how a multilayered approach
can be used to overcome gaps or failures in any particular
approach, how liability issues of different professional and
volunteer emergency response providers should be addressed, how
appropriate security will be incorporated, how information
regarding obtaining medical countermeasures should be
communicated to the public, and other items identified in this
subsection or that the Secretary of Health and Human Services
determines appropriate.
Subsection ``319(d)'' directs the responsible federal
agencies to coordinate with State, local, and tribal government
officials, private sector, and nongovernmental organizations
when developing the strategy.
Subsection ``319(e)'' requires the Secretary of Health and
Human Services, in coordination with the Secretary of Homeland
Security and the Postmaster General, to give Congress the
strategy within 180 days of enactment and to provide an
implementation plan 180 days after submission of the strategy.
A status report on the implementation of the strategy is due
one year after the submission of the implementation plan.
Section 202. Tailoring of the National Medical Countermeasure
Dispensing Strategy
This section requires that the Secretary of Health and
Human Services, in coordination with the Secretary of Homeland
Security and, where appropriate, the Postmaster General, tailor
implementation of the National Medical Countermeasure
Dispensing Strategy by developing specific plans for each
jurisdiction participating in the Cities Readiness Initiative
and for representative localities of varying size and
population makeup. The plans are to be developed in close
discussion with the representative State, local, and tribal
officials in those locations. The Secretary of Homeland
Security is to review elements of the tailored plan developed
by the Secretary of Health and Human Services for capabilities
for which the Department of Homeland Security has particular
expertise, including: security plans for infrastructure and
personnel, coordination among law enforcement personnel in
support of dispensing activities, logistical support during
disasters, and other items identified in this subsection or
that the Secretary of Homeland Security determines appropriate.
Section 203. Expansion in the use of the U.S. Postal Service to deliver
medical countermeasures
This section expands the existing program for using the
Postal Service to deliver medical countermeasures to five
additional cities within one year and fifteen additional cities
within two years.
Subsection 203(a) directs the Secretary of Health and Human
Services, in coordination with the Postmaster General and the
Secretary of Homeland Security, to expand the existing pilot
programs utilizing the United States Postal Service to deliver
medical countermeasures in an emergency.
Subsection 203(b) provides the timeline for the expansion,
contingent on the voluntary participation of additional
jurisdictions, to include five additional cities one year after
the date of enactment, and to include fifteen cities within two
years.
Subsection 203(c) establishes that the contents of the
medkits used in this program shall be reevaluated biennially.
Subsection 203(d) provides the criteria to be considered in
determining the contents of the medkits used in the program,
including available threat assessments and the public health
effects should such threats come to fruition.
Subsection 203(e) directs the Secretary of Health and Human
Services, the Postmaster General, and the Secretary of Homeland
Security to report on the implementation of this section.
Subsection 203(f) provides for definitions used in this
section.
Subsection 203(g) authorizes appropriation of funds
necessary to carry out this section.
Section 204. Dispensing medical countermeasures through employers
This section directs federal agencies to develop plans to
dispense medical countermeasures to their employees in the
event of a naturally occurring or man-made biological incident
and to create best practices for medical countermeasure
dispensing among private-sector entities. This section also
requires federal agencies to exercise those plans biennially.
Subsection 204(a) provides for definitions used in this
section.
Subsection 204(b) directs the head of each federal agency,
in consultation with the Secretary of Health and Human Services
and Secretary of Homeland Security, to develop a plan to
receive and dispense medical countermeasures to their
employees. This subsection describes the contents of the plans,
the review of those plans by the Secretaries of Health and
Human Services and Homeland Security, and directs that they
shall be exercised at least biennially.
Subsection 204(c) directs the Secretary of Health and Human
Services, in coordination with the Secretary of Homeland
Security, to establish a set of best practices for dispensing
medical countermeasures to employees for private sector
entities.
Subsection 204(d) directs the Secretary of Health and Human
Services, in coordination with the Secretary of Homeland
Security, to report on the implementation of this section.
Section 205. Personal ``Medkits'' for emergency response providers and
members of preparedness organizations
This section creates a program to provide personal medical
kits to emergency response providers, members of preparedness
organizations, and their immediate family members. Personal
medical kits, which could contain antibiotics or other medical
countermeasures that would be needed in the event of a WMD
attack, are currently provided to Postal Service employees
participating in the pilot program for delivering medical
countermeasures. Individuals receiving medical kits are
required to register with the Secretary of Homeland Security,
receive training on storage and use of the medical kits, and
report any use of a medical kit to the Secretary of Homeland
Security. Immediate family members are included so that
emergency response providers can focus on serving their
community without worrying that their possible exposure to the
WMD agent and cross contamination will put their families at
greater risk than the general public. This section authorizes
$20 million per year for fiscal years 2011-2013 for this
program.
Subsection 205(a) amends Title III of the Homeland Security
Act of 2002 (6 U.S.C. Sec. Sec. 181 et seq.) by adding
``Section 320. Personal Medkits for Emergency Response
Providers and Members of Preparedness Organizations.''
Subsection ``320(a)'' provides for definitions used in this
section.
Subsection ``320(b)'' directs the Secretary of Homeland
Security, in coordination with the Secretary of Health and
Human Services, to establish a medkit program for emergency
response providers, members of preparedness organizations, and
their immediate family members.
Subsection ``320(c)'' lays out elements of the emergency
response provider medkit program including that participants be
registered in the program, receive proper training, and undergo
appropriate medical screenings.
Subsection ``320(d)'' directs that the program be
coordinated with the Secretary of Health and Human Services and
the Commissioner of Food and Drugs to establish the contents of
the medkits and to attain an emergency use authorization for
the medkits to be used in this program, in a manner consistent
with applicable food and drug statutes.
Subsection ``320(e)'' directs the Secretary of Homeland
Security to report to Congress on the implementation of this
section.
Subsection ``320(f)'' authorizes $20 million for fiscal
years 2011 through 2013 for implementation of this section.
Subsection 205(b) provides for technical and conforming
amendments.
Section 206. General public ``Medkit'' pilot program
This section requires the Secretary of Health and Human
Services to conduct a pilot program to study the feasibility of
providing personal medkits to the public. The program will
evaluate the ability of households to maintain medical kits in
their homes as directed and reserved for emergency use.
Enrollment in the pilot program would encompass a diverse range
of municipalities, geographic locations, and socio-economic
statuses.
Subsection 206(a) provides for definitions used in this
section, including for the term ``medkit,'' which the
subsection defines as a cache of antibiotics and other medical
countermeasures to be used during a public health emergency.
Subsection 206(b) directs the Secretary of Health and Human
Services, in coordination with the Secretary of Homeland
Security, to conduct a pilot program to study the feasibility
of providing personal medkits to the public.
Subsection 206(c) describes the requirements for the medkit
pilot program, which is intended to enroll significantly more
participants than previous studies on the feasibility of home
medkits.
Subsection 206(d) directs that the pilot be coordinated
with the Commissioner of Food and Drugs to establish the
contents of the medkits and to attain an emergency use
authorization for the medkits to be used in this manner.
Subsection 206(e) directs that a report evaluating the
pilot program and providing recommendations for a national
program be delivered to Congress.
Subsection 206(f) authorizes appropriations necessary to
carry out this section.
Section 207. Report on the use of expiring countermeasures
This section directs the Secretary of Health and Human
Services to contract with the Institute of Medicine to study
the feasibility and effectiveness of using those medical
countermeasures in the Strategic National Stockpile that are
approaching expiration for pre-event or post-event vaccination
or treatment of emergency responders.
Subtitle B--Bioforensics Capabilities and Strategy
Section 211. Bioforensics capabilities and strategy
This section authorizes a National Bioforensics Analysis
Center and a repository collection at DHS as the lead federal
facility to conduct technical forensic analysis following a
bioattack in order to support identification of the
perpetrators. It directs federal agencies to provide samples of
relevant agents to the repository and instructs the Secretary
of Homeland Security to encourage participation by public and
private agent collections. This section also directs the
Secretary of Homeland Security to develop a National
Bioforensics Strategy laying out federal agencies' roles in
analyzing bioforensic evidence, coordination with State, local,
and tribal governments, and development of collection
standards.
Subsection 211(a) amends Title III of the Homeland Security
Act of 2002 (6 U.S.C. Sec. Sec. 181 et seq.), as amended, by
adding ``Section 321. Bioforensics Capabilities and Strategy.''
Subsection ``321(a)'' provides for definitions used in this
section.
Subsection ``321(b)'' authorizes the National Bioforensics
Analysis Center at the Department of Homeland Security. The
Center is to serve as the lead federal facility to conduct
technical forensic analysis following a bioattack in order to
support efforts to identify the perpetrators, to maintain a
national bioforensics repository collection, and to support
research on advancing threat agent characterization
capabilities and assay development.
Subsection ``321(c)'' establishes a National Bioforensics
Repository Collection at the National Bioforensics Analysis
Center. The repository is intended to receive, store, and
distribute the pathogen type strains it needs to support
bioforensic analysis, studies characterizing threat agents, and
the development of bioforensic assays. Other agencies that
possess strains needed to fulfill this purpose are directed to
make those strains and toxins available to the repository. The
Secretary of Homeland Security is also to work with public and
private biological agent and toxin collections whose samples
were funded by federal investments to contribute needed samples
to the repository. The Secretary is to establish mechanisms by
which other federal agencies as well as public or private
entities can access, as appropriate, the repository in order to
support bioforensics activities and research. The Secretary is
also directed to provide a report to Congress outlining how
concerns relating to intellectual property or rights to access
the repository among other issues are addressed.
Subsection ``321(d)'' directs the Secretary of Homeland
Security, in coordination with heads of relevant agencies, to
develop a National Bioforensics Strategy that provides for a
coordinated approach across all executive agencies for
bioforensic analysis and research and that describes the roles
and responsibilities of those agencies.
Subsection 211(b) provides for technical and conforming
amendments.
Subtitle C--Communications Planning
Section 221. Communications planning
This section directs the Secretary of Homeland Security,
acting through the FEMA Administrator, in consultation with
State, local, and tribal officials, to develop pre-scripted
messages and message templates to provide information quickly
to affected populations after natural disasters, acts of
terrorism, and other man-made disasters. The messages would be
developed in multiple formats to ensure delivery when the usual
communications infrastructure is rendered unusable and to
provide direction to individuals with disabilities or other
special needs. The FEMA Administrator will incorporate such
messages into exercises conducted under the National Exercise
Program.
Subsection 221(a) adds ``Section 525. Communications
Planning'' to Title V of the Homeland Security Act of 2002 (6
U.S.C. Sec. Sec. 311 et seq.).
Subsection ``525(a)'' directs the Secretary of Homeland
Security, through the Administrator of the Federal Emergency
Management Agency, to develop a public communications plan to
provide information relating to preventing, preparing for,
protecting against, and responding to imminent natural
disasters, acts of terrorism and other man-made disasters.
Subsection ``525(b)'' directs the Administrator, in
consultation with State, local, and tribal governments and in
coordination with other responsible federal agencies, to
develop pre-scripted messages or message templates that can be
used by the responding State, local, and tribal officials, if
they deem them to be necessary, to rapidly disseminate critical
information to the public or to emergency responders in
anticipation of the immediate aftermath of a disaster or
incident. The messages should address concepts such as
evacuation, sheltering in place and issues of immediate health
and safety.
Subsection ``525(c)'' directs that the pre-scripted
messages or templates should be designed for multiple
communications formats in order to ensure delivery even when
particular communications infrastructure is damaged by the
incident and to reach individuals with disabilities, special
needs, or limited English proficiency.
Subsection ``525(d)'' directs that the pre-scripted
messages and templates should be distributed to State, local,
and tribal governments, and that the Administrator provide
those governments with technical assistance related to
communications planning.
Subsection ``525(e)'' directs that the messages and
templates developed under this section are exercised.
Subsection ``525(f)'' directs the Administrator to report
to Congress on efforts to carry out this section.
Subsection 221(b) of the bill amends the table of contents
of the Homeland Security Act of 2002 (6 U.S.C. Sec. 101).
Section 222. Plume modeling
This section directs the Secretary of Homeland Security to
ensure the rapid development and dissemination of integrated
plume models that assess the location and predict the spread of
nuclear, radioactive, or chemical fallout of biological agents
resulting from an attack or release and that contain protective
action guidance. The Secretary of Homeland Security will also
establish mechanisms for dissemination by emergency response
providers of these plume models to nongovernmental
organizations and the public to ensure appropriate response
activities. In addition, the Secretary of Homeland Security is
required to ensure that DHS exercises the development and
dissemination of integrated plume models.
Subsection 222(a) provides definitions for this section,
including for the term ``plume model,'' which means assessment
of the location and prediction of the spread of nuclear,
radioactive, or chemical fallout and biological pathogens
resulting from an explosion or release of nuclear, chemical or
biological substances. The term ``integrated plume model''
incorporates the concept that protective action guidance and
other information are also included with the provided plume
models.
Subsection 222(b) directs the Secretary of Homeland
Security to develop and disseminate integrated plume models to
enable rapid response activities following a nuclear,
radiological, chemical or biological release. While the
integrated plume models are to be provided by the Secretary to
appropriate emergency response officials, it is expected that
integrated plume models incorporating protective action
guidance will be made in a publicly releasable format if public
release is deemed appropriate by the emergency response
officials in command of the incident response. The integrated
plume models should be developed in consultation with other
federal agencies, State, local, and tribal governments and
nongovernmental organizations involved in the response,
sheltering and care of affected individuals.
Subsection 222(c) directs the Secretary of Homeland
Security to ensure that the integrated plume models developed
pursuant to this section are exercised. Subsection 222(d)
instructs the Secretary of Homeland Security to produce a
report to Congress detailing the development of the integrated
plume models, lessons learned from exercising these products,
and plans for improving future versions.
Title III--International Measures to Prevent Biological Terrorism
Subtitle A--Prevention and Protection Against International Biological
Threats
Section 301. International threat assessment: Tier I agent facilities
This section requires that the DNI lead a review of
international biosecurity threats and provide the results to
Congress. The review shall assess global biological risks by
taking into account the presence and capabilities of foreign
terrorist organizations, the location of highest risk agent
collections, the location of laboratories with inadequate
security and any gaps in knowledge about international
biosecurity threats. The report must be submitted no later than
six months after enactment of the Act, and should be updated
biennially and submitted to specified Congressional committees.
The DNI must also submit an unclassified summary and a
classified annex no later than six months after enactment of
the Act and biennially thereafter to specified Congressional
committees. This last requirement will sunset five years after
enactment.
Section 302. Strengthening international biosecurity
This section directs the Secretary of State to provide
technical assistance to countries or regions identified by the
threat assessment mandated by section 301 in removing,
consolidating, and otherwise improving security for Tier I
agent collections. The section further directs the Secretary to
raise awareness of biological threats internationally, provide
physical and other security upgrades to high-risk laboratories,
and train countries in biosecurity best practices. Finally,
this section requires the Secretary of State to promote
research and development collaboration on highly infectious
diseases and to provide opportunities for foreign scientists to
receive training in the United States on biological safety and
security.
Section 303. Promoting secure biotechnology advancement
Subsection 303(a) directs the Secretary of State to develop
a strategy for promoting international adherence to agreements
regarding WMD including the Biological Weapons Convention and
World Health Organization International Health Regulations.
Subsection 303(b) directs the Secretary to pursue
discussions with government, academic and industry
representatives in countries with established or emerging
biotechnology sectors concerning safeguards to prevent the
misuse of biotechnology and initiatives to counter biological
terrorism.
Subtitle B--Global Pathogen Surveillance
Section 321. Short title
This section provides the short title of the subtitle as
the ``Global Pathogen Surveillance Act of 2009.''
Section 322. Findings; purpose
This section describes the findings and purpose of this
subtitle, namely to enhance the capability of the international
community through international health organizations and
individual countries, to detect, identify, and contain
infectious disease outbreak whether caused by intentional human
action or natural sources.
Section 323. Definitions
This section provides the definitions used in this
subtitle.
Section 324. Eligibility for assistance
This section describes the eligibility requirements for
developing countries and individuals to receive assistance
under this subtitle, including that (1) countries are
developing and have agreed to the objective of fully complying
with requirements of the World Health Organization on reporting
public health information on outbreaks of infectious diseases
and to provide pathogen surveillance data to the United States
and international health organizations, and (2) individuals do
not have a criminal background or ties to any foreign terrorist
organization.
Section 325. Restriction
This section prohibits the access by foreign nationals
participating in programs created by the subtitle to agents
that may be used as biological weapons except in a supervised
and controlled setting.
Section 326. Fellowship program
This section establishes a fellowship program for foreign
nationals of eligible developing countries, as defined in
section 324, to pursue a Master of Public Health degree or
advanced studies in epidemiology, provided that the individuals
agree to work in public health or public health-related
positions in their home countries for four years. A U.S.
citizen may participate on a case-by-case basis provided that
individual agrees to work for five years in a public health
position in an eligible country or an international health
organization.
Section 327. In-country training in laboratory techniques and disease
and syndrome surveillance
This section directs the Secretary of State to develop
short training courses for foreign nationals of eligible
developing countries (as defined in section 324) who are
laboratory technicians, health care providers, or public health
officials on how to identify agents responsible for infectious
disease outbreaks, diagnose such diseases, and track and
analyze such outbreaks.
Section 328. Assistance for the purchase and maintenance of public
health laboratory equipment and supplies
This section authorizes the President to assist eligible
developing countries, as defined in section 324, in purchasing
and maintaining public health laboratory supplies and
equipment. Such assistance may be provided only if the country
agrees to house, maintain, support, secure, and maximize the
use of such supplies and equipment.
Section 329. Assistance for improved communication of public health
information
This section authorizes the President to assist eligible
developing countries, as defined in sections 323 and 324, in
purchasing and maintaining communications and information
technology necessary to collect, analyze, and transmit public
health information. Such assistance may only be provided if the
country agrees to house, maintain, support, secure, and
maximize the use of such technology.
Section 330. Assignment of public health personnel to United States
missions and international organizations
This section authorizes an agency head to assign an
employee, with the employee's and the Secretary of State's
concurrence, to a diplomatic mission or international health
organization in order to enhance disease or pathogen
surveillance in developing countries.
Section 331. Expansion of certain United States Government laboratories
abroad
This section permits the Director of the Centers for
Disease Control and Prevention and the Secretary of Defense to
increase the number of employees and to expand the operations
of those agencies' laboratories located in eligible developing
countries, as defined in sections 323 and 324, including by
increasing the capacity to train foreign nationals at such
facilities.
Section 332. Assistance for international health networks and expansion
of field epidemiology training programs
This section authorizes the President to assist the
enhancement of the surveillance and reporting capabilities of
the World Health Organization and other international health
networks and to establish new international health networks.
The section further authorizes the Secretary of Health and
Human Services to establish new international Field
Epidemiology Training Programs in eligible developing
countries, as defined in sections 323 and 324.
Section 333. Reports
This section directs the Secretary of State to report to
Congress on implementation of this subtitle.
Section 334. Authorization of appropriations
This section authorizes appropriations to carry out
activities under this subtitle.
Subtitle C--Strengthening the Oversight of Nuclear Nonproliferation
Section 351. Definitions
This section of the bill defines ``appropriate
Congressional committees'', ``Commission'', ``Coordinator'',
``Deputy Coordinator'', ``highly enriched uranium'', ``IAEA'',
and ``special nuclear material''.
Section 352. Report on United States nuclear nonproliferation efforts
Subsection 352(a) instructs the President's Coordinator for
the Prevention of Weapons of Mass Destruction Proliferation and
Terrorism to submit a report one year after the date of
enactment, and annually thereafter, to the appropriate
Congressional committees.
Subsection 352(b) describes the content of the report,
which requires: (1) a detailed description of the financial
incentives used by the U.S. to promote civilian nuclear energy
abroad; (2) a statement of U.S. actions to improve the secure
civilian storage, and minimize the use and export, of weapons
usable highly enriched uranium and the amount the U.S. spends
to fuel U.S. civilian reactors with highly enriched uranium;
(3) a description of the actions that the U.S. has taken to
implement the Energy Development Program mandated by the
Nuclear Non-Proliferation Act of 1978; (4) a description of the
steps the U.S. has taken to improve the physical security of
civilian special nuclear material; (5) an assessment of the
capabilities of the International Atomic Energy Agency (IAEA),
completed in consultation with all relevant agencies, including
the Office of the Director of National Intelligence, to include
IAEA's ability to meet its own timely detection and inspection
goals, IAEA's ability to actually detect military diversions,
and recommendations on updating IAEA definitions of the amount
of time it takes, and amount of special nuclear material
needed, to convert special nuclear material into a bomb, and
recommendations regarding how the U.S. could improve IAEA's
capabilities.
Subsection 352(c) requires the President to submit the
report in the absence of the Coordinator and Deputy
Coordinator.
Section 353. Report on United States work with IAEA on nuclear
nonproliferation
Subsection 353(a) instructs the Coordinator to submit a
report one year after the date of enactment to the appropriate
Congressional committees.
Subsection 353(b) describes the content of the report,
which shall detail the progress of U.S. work with IAEA's
Director General to: (1) establish a safeguards user fee that
would require countries with inspected facilities to help cover
the costs of IAEA inspections; (2) assess whether the IAEA can
meet its own inspection goals, whether those goals afford
timely detection to account for a bomb's worth of special
nuclear material, whether there are situations in which
achieving those goals is not possible, and what corrective
actions may be needed to help the IAEA in achieving those
goals; (3) promote transparency at suspect sites and encourage
member states to track all foreign visitors at safeguarded
sites; (4) provide for the acquisition and implementation of
near-real-time surveillance equipment in the use of safeguards,
including at sites where nuclear fuel rods are located; (5)
require that the transfer of items on the Nuclear Suppliers
Group dual-use and trigger lists be reported to IAEA in advance
and that a system be developed to analyze those transfers.
Subsection 353(c) requires the President to submit the
report in the absence of the Coordinator and Deputy
Coordinator.
Section 354. Authorization of appropriations
This section authorizes appropriations as may be necessary
to carry out the reporting requirements for both reports fiscal
year 2010 and each year thereafter.
Subtitle D--Energy Development Program Implementation
Section 361. Findings
This section of the bill provides Congressional findings,
including (1) that Title V of the Nuclear Non-Proliferation Act
of 1978 requires the U.S. to work with developing countries in
assessing and finding ways to meet their energy needs through
alternatives to nuclear energy, and (2) that the Commission on
the Prevention of WMD Proliferation and Terrorism recommends
that Title V be implemented to help reduce the risk of nuclear
proliferation.
Section 362. Definitions
This section provides definitions for ``appropriate
Congressional committees'', ``energy development program'', and
``Secretary''.
Section 363. Energy development program implementation
Subsection 363(a) instructs the Secretary of Energy to
develop strategic and implementation plans for the energy
development program and to submit them to the appropriate
Congressional committees not later than 180 days after the date
of enactment.
Subsection 363(b) requires the Secretary to implement the
plans not later than 180 days after the date they were
submitted to the appropriate Congressional committees.
Subsection 363(c) specifies that Federal employees serving
in an exchange capacity in an energy development program are
considered to be detailed. These employees shall retain their
allowance, privileges, rights, and seniority afforded them by
their original employing agency.
Subsection 363(d) authorizes necessary sums to carry out
this section for fiscal year 2010 and each fiscal year
thereafter.
Section 364. Reports
Subsection 364(a) requires that an annual report be
submitted by the Secretary of Energy to the appropriate
Congressional committees not later than one year after the date
of implementation of the plans and every year thereafter.
Subsection 364(b) requires that a report on the Alternative
Energy Corps, including how this Corps could be expanded into
an international cooperative effort, be submitted by the
Secretary to the appropriate Congressional committees not later
than one year after the date of the implementation of plans.
This latter report is to include an analysis and description of
how a Corps of technically trained volunteers could support the
search for and use of non-nuclear, indigenous energy sources
and the application of suitable technology, including renewable
energy technology, in developing countries. The report also is
to include a description of other mechanisms that are available
to coordinate an international effort to advance the use of
suitable technologies in developing countries.
Title IV--Government Organization
Section 401. Intelligence on weapons of mass destruction
This section requires the DNI to develop a strategy for
improving intelligence collection, analysis, and dissemination
related to WMD, including the relationship between WMD and
terrorism. Subsection 401(b) requires that, not later than 120
days after the enactment of this bill, the DNI shall develop
and implement the strategy and submit it to the Congressional
committees specified in subsection 401(a).
Subsection 401(b) specifies six substantive elements that
the strategy must contain, including recruitment of individuals
with relevant expertise in WMD intelligence such as scientific
and technical knowledge; collaboration with nongovernmental
entities; analytic questions and gaps in knowledge to guide
collection; development of innovative collection techniques;
actions to increase information-sharing and a description of
any barriers thereof; and actions to overcome foreign denial
and deception. In addition, subsection 401(b) contains five
process elements that the strategy must contain, including
prioritized objectives and a schedule for meeting them annually
for the first five years of the strategy; assignment of roles
and responsibilities in the Intelligence Community; a
description of the personnel and financial resources necessary
to implement the strategy; metrics to measure efficiency and
effectiveness; and a schedule for assessing the strategy.
Subsection 401(c) requires that the DNI submit a report
every 180 days after submission of the strategy, for a period
of three years, to the Congressional committees specified in
subsection 401(a). Each report shall include an assessment of
the accomplishment of the strategy's objectives, data related
to the strategy's metrics, a description of actions taken to
implement the strategy, and an assessment of whether resources
are sufficient to fulfill the strategy.
Section 402. Intelligence language capabilities and cultural knowledge
This section requires the DNI to develop a strategy for
recruiting employees with critical language skills and cultural
backgrounds relevant to counterterrorism or WMD intelligence,
including individuals who are first- or second-generation U.S.
citizens and U.S. citizens with immediate relatives who are
foreign nationals. Subsection 402(b) requires that, not later
than 180 days after the enactment of this bill, the DNI shall
develop and implement a strategy and submit it to the
Congressional committees specified in subsection 402(a).
Subsection 402(b) specifies three substantive elements that
the strategy must contain, including the Intelligence
Community's need for employees with critical language
capabilities and cultural backgrounds relevant to
counterterrorism and WMD intelligence over a ten-year period,
actions necessary to recruit, train, and retain such
individuals, and barriers to effective recruitment, training,
and retention, including security clearance processing. In
addition, subsection 402(b) contains five process elements that
the strategy must contain, including prioritized objectives and
a schedule for meeting them annually for the first five years
of the strategy; assignment of roles and responsibilities in
the Intelligence Community; a description of the personnel and
financial resources necessary to implement the strategy;
metrics to measure efficiency and effectiveness; and a schedule
for assessing the strategy.
Subsection 402(c) requires that the DNI submit a report
every 180 days after submission of the strategy, for a period
of three years, to the Congressional committees specified in
subsection 402(a). Each report shall include an assessment of
the accomplishment of the strategy's objectives, data related
to the strategy's metrics, a description of actions taken to
implement the strategy, and an assessment of whether resources
are sufficient to fulfill the strategy.
Section 403. Counterterrorism technology assessment
This section strengthens the science and technical
capabilities of the Congressional Research Service (CRS) and
the Government Accountability Office (GAO) for providing
Congress with assessments of counterterrorism technology in
order to inform Congress's consideration of legislative
proposals on such matters.
Subsection 403(a) defines the term ``agency'' in this
section to mean any department, agency, or instrumentality of
the executive branch of the Government.
Subsection 403(b) requires the Director of CRS to establish
an interdisciplinary capability in furtherance of CRS's
responsibilities to advise Congress concerning technology or
technological applications developed or used for
counterterrorism. Subsection 403(b) authorizes $2 million for
each of fiscal years 2011 to 2013 for this purpose.
Subsection 403(c) requires the Comptroller General of the
United States (the head of GAO) to establish an
interdisciplinary capability at GAO to conduct assessments of
technology or technological applications that are being
developed or are being used, or are available to be used,
either by the Executive Branch to counter terrorism or pursuant
to a legislative proposal under consideration in Congress or
proposed by the Executive Branch. Subsection 403(c) specifies
that each assessment of a technology or technological
application for counterterrorism shall include its actual or
anticipated impact, effectiveness, and efficiency as well as
any test results, technological alternatives, actual and
anticipated costs and benefits, actual or anticipated
countermeasures, and the Executive Branch's own assessment. The
interdisciplinary capability shall include personnel with
relevant expertise--including science, technology, homeland
security, or other fields deemed appropriate--and may include
outside experts or consultants. Subsection 403(c) authorizes $2
million for each of fiscal years 2011 to 2013 for this purpose.
Subsection 403(d) states that the Comptroller General of
the United States shall, as appropriate, contract with the
National Academy of Sciences to assess technology and
technological applications that are being or could be developed
for counterterrorism. Subsection 403(d) specifies that each
such assessment include determining trends related to the
development of technology or technological applications,
identifying particular technology or technological applications
that may become available or are necessary, and recommending
government investments for the development of technology or
technological applications. Subsection 403(d) authorizes $2
million for each of fiscal years 2011 to 2013 for this purpose.
Title V--Emergency Management and Citizen Engagement
Section 501. Improved communications of threat information and alerts
This section requires the Secretary of Homeland Security,
in coordination with the FBI Director, to provide terrorism-
related threat and risk assessments to the public. The
Secretary of Homeland Security is required to prepare
unclassified terrorism-related threat and risk assessments,
including guidelines for the public to prevent and respond to
acts of terrorism, and to provide State, local, and tribal
governments with guidelines on how to disseminate terrorism-
related threat and risk information to the public.
Subsection 501(a) finds that the WMD Commission recommended
that the federal government practice greater openness of public
information so that citizens better understand the threat and
risk to them.
To this end, subsection 501(b) amends section 203 of the
Homeland Security Act of 2002, as amended, to require that the
Secretary of Homeland Security, in coordination with the
Attorney General, ensure that information concerning terrorist
threats is available to the general public within the United
States. To do so, the Secretary of Homeland Security shall
prepare unclassified terrorism-related threat and risk
assessments on a timely basis. Each assessment shall include
guidelines for the general public to prevent and respond to
terrorism and be available through publicly accessible
communication systems such as DHS's website. The amendment
contained within subsection 501(b) also requires the Secretary
to provide guidelines to State, local, and tribal governments
on disseminating information concerning terrorism threats and
risks to the general public.
Subsection 501(c) amends section 201 of the Homeland
Security Act of 2002, as amended, to broaden the
responsibilities of the Secretary relating to intelligence and
analysis and infrastructure protection by mandating that the
Secretary disseminate information, as appropriate, not just to
governmental and private sector entities with responsibilities
related to homeland security but also to the general public in
order to assist in deterring, preventing, or responding to
terrorism.
Subsection 501(d) requires that the Secretary submit a
report to the Senate Homeland Security and Governmental Affairs
Committee and the House Homeland Security Committee not later
than 180 days after the enactment of this bill on
implementation of section 203 of the Homeland Security Act of
2002, as amended, which concerns the Homeland Security Advisory
System.
Section 502. Guidelines concerning weapons of mass destruction
The response to an explosion or release of nuclear,
radiological, biological, or chemical material will require
specialized procedures and precautions for emergency response
providers to respond effectively and safely to a weapon of mass
destruction event. The expertise required to develop those
specialized procedures often lies at the federal level, among
non-governmental organizations or is dispersed among particular
local entities. To be effective, these procedures need to be
developed and exercised before an event. This section requires
the Secretary of Homeland Security to review existing
guidelines and revise or develop new guidelines with State,
local, and tribal governments, nongovernmental organizations,
and the private sector guidelines for which there is
insufficient guidance on responding to a WMD attack.
Subsection 502(a) directs the Secretary of Homeland
Security to develop the guidelines in coordination with, and
distribute those guidelines to, members of emergency response
provider organizations and State, local, and tribal
governments.
Subsection 502(b) specifies the minimum contents of the
guidelines, to include: the hazardous effects of the WMD agent,
the protective practices for the first responder, and how to
care for individuals injured or contaminated by the agent.
Subsection 502(c) requires that the guidelines be reviewed
and revised if needed at least biennially.
Subsection 502(d) describes the process by which the
guidelines are to be developed and revised and includes, among
other steps, assessing the appropriateness of existing
guidelines for these purposes. The Committee is aware that
there have been other efforts to develop such guidelines, such
as a terrorism response checklist that the International
Association of Fire Chiefs distributes to its members. To the
extent there are already existing, relevant guidelines for
first responders, the intent of this section is that the
Secretary evaluate and, where appropriate, build on such
guidelines and not to require the Secretary to start over or to
ignore previous efforts that serve as instructive models.
Subsection 502(e) directs that the Secretary of Homeland
Security shall consult with other federal agencies, State,
local, and tribal governments, and nongovernmental
organizations and private industry in developing and revising
these guidelines.
Subsection 502(f) requires that an annual report be
provided to Congress describing the progress and future
development of these guidelines.
Subsection 502(g) provides that ``emergency response
provider'' has the definition given to it in section 2 of the
Homeland Security Act of 2002 (6 U.S.C. Sec. 101) and includes
Federal, State, and local governmental and nongovernmental
emergency public safety, fire, law enforcement, emergency
response, emergency medical (including hospital emergency
facilities), and related personnel, agencies, and authorities.
Section 503. Citizen and community preparedness
This section requires the FEMA Administrator to assist
State, local, and tribal governments in promoting individuals'
and communities' preparedness for natural disasters, acts of
terrorism, and other man-made disasters. Such assistance shall
include developing guidelines, compiling best practices,
providing training materials, and conducting individual and
community preparedness outreach efforts. This section also
requires the Administrator to appoint a Director of Community
Preparedness to oversee the Agency's activities in this area.
Finally, this section permits the Administrator to make grants
to States to support individual and community preparedness and
authorizes $15 million in fiscal year 2011 and $20 million in
each of fiscal years 2012 and 2013.
Subsection 503(a) amends Title V of the Homeland Security
Act of 2002 (6 U.S.C. Sec. Sec. 311 et seq.) by adding
``Section 526. Citizen and Community Preparedness.''
Subsection ``526(a)'' of the new section 526 directs the
Administrator of the Federal Emergency Management Agency to
assist State, local, and tribal governments in promoting
individual and community preparedness by developing best
practices, guidelines and checklists for prevention and
preparedness efforts and conducting individual and community
preparedness outreach efforts.
Subsection ``526(b)'' directs the FEMA Administrator to
coordinate with private sector and nongovernmental
organizations in promoting preparedness.
Subsection ``526(c)'' directs the Administrator to work
with and provide support to volunteer preparedness programs,
including those sponsored by nongovernmental organizations.
Subsection ``526(d)'' directs the Administrator to appoint
a Director of Community Preparedness to coordinate and oversee
the individual and community preparedness efforts of the
Federal Emergency Management Agency.
Subsection ``526(e)'' authorizes appropriations for grants
to States to support individual and community preparedness
programs through 2013.
Subsection 503(b) of the bill amends the authorities and
responsibilities of the Federal Emergency Management Agency
Administrator in section 504(a) of the Homeland Security Act of
2002 (6 U.S.C. Sec. Sec. 314(a)) to include enhancing and
promoting the preparedness of individuals and communities for
natural disasters, acts of terrorism, and other man-made
disasters.
Subsection 503 (c) is a conforming amendment to the table
of contents of the Homeland Security Act of 2002 (6 U.S.C.
Sec. Sec. 101 et seq.).
V. Evaluation of Regulatory Impact
Pursuant to the requirements of paragraph 11(b)(1) of rule
XXVI of the Standing Rules of the Senate, the Committee has
considered the regulatory impact of this bill. S. 1649 would
impose additional security mandates on certain laboratories and
personnel currently regulated under the National Select Agent
Program. At the same time, it would reduce the regulatory
burden on other currently regulated laboratories and personnel,
and remove some completely from the National Select Agent
Program and its requirements. Also, laboratories and personnel
that work on certain agents that pose a minimal level of
concern may face additional registration requirements without
security mandates. And entities that receive, synthesize, or
handle DNA from the Variola virus will face new regulations. To
the extent that State, local, or tribal governments operate
laboratories subject to the bill's requirements, they would see
increased or decreased regulation along the lines of that
experienced by private sector laboratories. Those institutions,
however, and like private sector labs, would benefit from grant
funding authorized to offset those costs. State, local, and
tribal governments would also benefit from grant programs
intended to strengthen individual and community preparedness.
In light of the fact that the bill both increases and
decreases regulatory requirements and that the precise impact
of the new requirements cannot be calculated prior to the
issuance of the new regulations required by the bill, the
Committee agrees with CBO, as expressed in its cost estimate
included in section VI below, that although the new federal
regulations would impose intergovernmental and private-sector
mandates as defined in the Unfunded Mandates Reform Act, the
types of restrictions, the number of entities regulated under
such regulations, and the final costs cannot currently be
estimated. Nor, as CBO notes, can it be determined whether
these costs would exceed the annual thresholds for
intergovernmental or private-sector mandates.
With respect to personal privacy, S. 1649 requires
additional personnel reliability measures that may have an
impact on the personal privacy of certain individuals who are
already required to register under the National Select Agent
Program, undergo credit checks, and submit to a federal
background check.
Finally, because a determination of any additional
paperwork or recordkeeping resulting from the bill depends on
requirements of the future regulations and the number of
entities those regulations will affect, the Committee could not
estimate the amount of any such paperwork or recordkeeping, or
the time and financial costs required of the affected parties.
VI. Congressional Budget Office Cost Estimate
November 19, 2010.
Hon. Joseph I. Lieberman,
Chairman, Committee on Homeland Security and Governmental Affairs, U.S.
Senate, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 1649, the WMD
Prevention and Preparedness Act of 2009.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Mark
Grabowicz.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
S. 1649--WMD Prevention and Preparedness Act of 2009
Summary: CBO estimates that S. 1649 would authorize the
appropriation of $945 million over the 2011-2015 period for
programs in the Department of Homeland Security (DHS), the
Department of Health and Human Services (HHS), and other
agencies to address the threat of weapons of mass destruction.
Assuming appropriation of the necessary amounts, CBO
estimates that implementing S. 1649 would cost $720 million
over the 2011-2015 period. Enacting the bill could have an
insignificant effect on revenues; therefore, pay-as-you-go
procedures apply. Enacting S. 1649 would not affect direct
spending.
S. 1649 would impose intergovernmental and private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
because it would require public and private laboratories and
other facilities to comply with new security standards. The
number of entities that would be affected and the types of
security measures to be required would depend on future
regulatory actions; therefore, CBO cannot estimate the costs of
the mandate. Consequently, CBO cannot determine whether the
costs would exceed the annual thresholds for intergovernmental
or private-sector mandates ($70 million and $141 million,
respectively, in 2010 dollars adjusted annually for inflation).
Estimated cost to the Federal Government: The estimated
budgetary impact of S. 1649 is shown in the following table.
The costs of this legislation fall within budget functions 150
(international affairs), 270 (energy), 350 (agriculture), 450
(community and regional development), 550 (health), 750
(administration of justice), and 800 (general government).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
--------------------------------------------------
2011 2012 2013 2014 2015 2011-2015
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATIONa
DHS Programs:
Estimated Authorization Level............................ 112 117 118 78 29 454
Estimated Outlays........................................ 38 52 65 69 75 299
HHS Programs:
Estimated Authorization Level............................ 84 69 63 65 66 347
Estimated Outlays........................................ 32 74 66 62 64 298
Other Programs:
Estimated Authorization Level............................ 31 31 31 25 26 144
Estimated Outlays........................................ 18 26 29 25 25 123
Total Changes:
Estimated Authorization Level.................... 227 217 212 168 121 945
Estimated Outlays................................ 88 152 160 156 164 720
----------------------------------------------------------------------------------------------------------------
a In addition to the costs shown above, enacting S. 1649 could affect revenues, but CBO estimates that any such
effects would be insignificant.
Note: DHS = Department of Homeland Security; HHS = Department of Health and Human Services.
Basis of estimate: For this estimate, CBO assumes that the
bill will be enacted before the end of 2010, that the necessary
amounts will be appropriated near the start of each fiscal
year, and that spending will follow historical patterns for
similar activities.
Spending subject to appropriation
DHS Programs. CBO estimates that S. 1649 would authorize
the appropriation of $454 million over the 2011-2015 period for
several DHS programs and activities. Assuming appropriation of
the necessary amounts, CBO estimates that outlays would total
$299 million over that time period.
S. 1649 would authorize the appropriation of $50 million
annually over the 2011-2014 period for the Federal Emergency
Management Agency (FEMA) to make grants to state, local, and
tribal governments and nonprofit institutions to improve
security at laboratories that contain certain toxins. The bill
also would authorize the appropriation of $15 million in 2011
and $20 million for each of 2012 and 2013 for FEMA to make
grants to states to help individuals and communities prepare
for natural disasters, acts of terrorism, and other
catastrophes. CBO estimates that implementing those grant
programs would cost $107 million over the 2011-2015 period and
an additional $148 million after 2015.
The legislation would authorize the appropriation of $20
million annually over the 2011-2013 period for DHS to establish
a program to distribute antidotes and medical countermeasures
to emergency-response providers and their families. CBO
estimates that this program would cost $60 million over the
2011-2014 period.
S. 1649 would authorize appropriations for the existing
National Bioforensics Analysis Center, which collects, stores,
and analyzes evidence from acts of bioterrorism and other
crimes. The bill would authorize the appropriation of such sums
as may be necessary for the center. For fiscal year 2010, the
Congress appropriated about $17 million for the National
Bioforensics Analysis Center. CBO estimated future funding
levels by adjusting the 2010 level for anticipated inflation.
We estimate that this provision would cost about $86 million
over the 2011-2015 period.
In addition, S. 1649 would require DHS to establish
regulations for instituting security measures at laboratories
that contain certain toxins and to enforce those measures. The
bill would require DHS to establish guidelines for emergency
service personnel to improve the response to incidents
involving weapons of mass destruction. The legislation also
would require the department to develop and disseminate plume
models (assessments of the spread of radioactive and other
fallout from weapons of mass destruction) to appropriate
emergency-response officials. Based on the costs of similar
activities, CBO estimates that it would cost DHS about $46
million to carry out these provisions over the next five years.
HHS Programs. CBO estimates that implementing S. 1649 would
require the appropriation of $347 million over the 2011-2015
period for activities to be conducted by the Department of
Health and Human Services; resulting outlays would total $298
million over the five-year period.
S. 1649 would modify and expand the requirement for the
Secretaries of HHS and Agriculture to create a tiered list of
certain toxins considered threats to the United States; that
list was established in an executive order issued on July 2,
2010 (Executive Order 13546). The bill would require those
agencies to provide DHS with a list of locations that store
those toxins. DHS would develop and enforce the security
regulations for facilities that contain those toxins.
S. 1649 also would require the Secretary of HHS to:
Establish a list of biological toxins that
could pose a threat to the health of individuals,
animals, or plants, and maintain a database of the
laboratories that possess those toxins, the individuals
in contact with them, and any facilities that could be
misused for the purpose of developing a biological
weapon;
Ensure that the appropriate agencies have
access to the databases that maintain information
regarding dangerous toxins; and
Regulate the distribution, synthesis, and
handling of variola virus DNA, which is used by
research entities to prevent or treat smallpox.
Based on information from HHS and accounting for
overlapping activities specified in the executive order, CBO
estimates that those provisions would cost $36 million over the
2011-2015 period.
S. 1649 would require HHS to establish and implement a
strategy for dispensing antidotes or other countermeasures to
mitigate the effects of a terrorist attack with chemical,
biological, radiological, or nuclear materials. Those
activities would overlap to a considerable degree with
activities under Executive Order 13527, issued on December 30,
2009; that order requires the Secretaries of DHS and HHS to
establish mechanisms for providing medical countermeasures
following a biological attack.
The legislation also would:
Direct each agency in the executive branch to
develop a plan to dispense countermeasures to its employees in
certain facilities. The Secretary of HHS would review and
approve those plans and establish a set of best practices
applicable for entities in the private sector.
Expand an existing program established by HHS that
uses the U.S. Postal Service to deliver medical countermeasures
in the event of an emergency. The program would be expanded to
five cities in the first year and 15 cities in the second year,
contingent upon the voluntary participation of additional
jurisdictions.
Require HHS to conduct a pilot program to study
the feasibility of providing personal medical kits to the
public. The medical kits would include antibiotics and other
medical countermeasures as determined by HHS.
Based on information from HHS and accounting for activities
already required by that executive order, CBO estimates that
implementing those provisions would cost $262 million over the
2011-2015 period.
Other Programs. CBO estimates that S. 1649 would authorize
the appropriation of $144 million over the 2011-2015 period for
other programs and activities. Assuming appropriation of the
necessary amounts, we estimate that outlays over that period
would total $123 million.
The bill would authorize the Department of State to provide
assistance to foreign countries that are deemed to be at high
risk for biological threats. The State Department currently
engages with about 30 such countries to address biological
threats and already meets many of the bill's requirements.
Based on information from the department, CBO estimates that
the department would require additional appropriations of about
$14 million a year to meet certain new requirements under the
bill and that implementing those requirements would cost $52
million over the 2011-2015 period. Those new requirements would
be to assist countries in securing dangerous pathogens,
ensuring the reliability of laboratory personnel, collaborating
in bioforensics, adhering to international agreements on
biological weapons, and purchasing and maintaining
communications equipment and information technology.
The bill also would require the Secretary of Energy to
provide assistance to developing countries to help them use
more renewable energy and less petroleum fuels. Recently, the
Department of Energy has initiated an international program
called the Energy Development in Island Nations (EDIN)
initiative. That program promotes the use of clean energy in
Iceland, New Zealand, and the U.S. Virgin Islands. Based on
information from the Department of Energy on the cost of
expanding that program to additional countries, CBO estimates
that implementing this provision would require additional
appropriations of about $10 million a year and, assuming that
the increased efforts would start immediately, we estimate that
costs would total $48 million over the 2011-2015 period.
S. 1649 would authorize the appropriation of $6 million
annually over the 2011-2013 period for the Congressional
Research Service and the Government Accountability Office to
study and assess how advances in technology might be used to
combat terrorism. CBO estimates that implementing this
provision would cost $18 million over the 2011-2014 period.
Finally, S. 1649 would authorize a number of activities
intended to enhance the ability of the international community
to detect, identify, and contain outbreaks of infectious
diseases. Based on information from the Department of
Agriculture, CBO estimates that under those initiatives an
expansion of activities already carried out by the department
with Foreign Animal Disease Funds would cost approximately $5
million over the next five years.
Revenues. S. 1649 could increase revenues because the
legislation would establish civil penalties for violating the
regulations established by DHS and HHS. Civil fines are
recorded as revenues and deposited in the Treasury. CBO
estimates that any additional revenues would not be significant
because of the small number of cases likely to be affected.
Pay-as-you-go considerations: The Statutory Pay-As-You-Go
Act of 2010 establishes budget-reporting and enforcement
procedures for legislation affecting direct spending or
revenues. The changes in revenues that are subject to those
pay-as-you-go procedures are shown in the following table.
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------------------------------------------------------------
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2011-2015 2011-2020
--------------------------------------------------------------------------------------------------------------------------------------------------------
NET INCREASE OR DECREASE (-) IN THE DEFICIT
Statutory Pay-As-You-Go Impact.................... 0 0 0 0 0 0 0 0 0 0 0 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intergovernmental and private-sector impact: Under current
law, laboratories must register with the National Select Agent
Registry if they possess, use, or transfer certain materials or
toxins. They also must comply with security standards for
conducting risk assessments. S. 1649 would impose additional
duties on laboratories if they possess, use, or transfer
certain materials or toxins that are designated as tier I
threats. Those laboratories would be required to comply with
new security standards in addition to new standards for
conducting background checks, training personnel, and
performing vulnerability assessments.
S. 1649 also would require all individuals, laboratories,
or other facilities that possess, use, or transfer certain
biological agents or toxins to register with the Secretary of
DHS.
Finally, the bill would require entities that currently
receive, synthesize, or handle DNA from the Variola virus to
meet new requirements determined by the Secretary. Those new
requirements would determine who is qualified to receive the
DNA, establish rules regarding distribution of the DNA, place
limits on the amount of DNA provided to laboratories, place
limits on the synthesis of the DNA, and enforce any other
regulations deemed necessary by the Secretary.
The requirement to comply with the new federal regulations
would impose intergovernmental and private-sector mandates as
defined in UMRA. The Secretary of HHS, in coordination with the
Secretary of DHS, would have broad authority to add or remove
materials from the list of tier I threats or registry agents at
any time. Because the number of entities that would be affected
and the types of limits and security measures required would
depend on those future regulations, CBO cannot estimate the
cost of the mandates. Consequently, CBO cannot determine
whether the costs would exceed the annual thresholds for
intergovernmental or private-sector mandates ($70 million and
$141 million in 2010, respectively, adjusted annually for
inflation).
Grant funding authorized by the bill for enhancing security
at laboratories would benefit certain state, local, and tribal
governments, including public institutions of higher education.
Previous CBO estimate: On October 26, 2010, CBO transmitted
a cost estimate for H.R. 5498, the WMD Prevention and
Preparedness Act of 2010, as ordered reported by the House
Committee on Homeland Security on June 23, 2010. We estimated
that implementing H.R. 5498 would cost $455 million over the
2011-2015 period, assuming appropriation of the necessary
amounts, and that enacting that legislation also would reduce
direct spending by $23 million over the 2011-2020 period. There
are many differences between the bills and the cost estimates
reflect those differences.
Estimate prepared by: Federal Costs: DHS--Mark Grabowicz;
HHS--Stephanie Cameron and Andrea Noda; Department of
Agriculture--Greg Hitz; Department of State--Sunita D'Monte;
Department of Energy--Raymond Hall.
Impact on State, local, and Tribal governments: Lisa
Ramirez-Branum.
Impact on the private sector: Sarah Axeen.
Estimate approved by: Theresa Gullo, Deputy Assistant
Director for Budget Analysis.
VII. Changes in Existing Law Made by the Bill, as Reported
In compliance with paragraph 12 of rule XXVI of the
Standing Rules of the Senate, changes in existing law made by
S. 1649 as reported are shown as follows (existing law proposed
to be omitted is enclosed in brackets, new matter is printed in
italic, and existing law in which no change is proposed is
shown in roman):
PUBLIC HEALTH SERVICE ACT
Public Law 78-410
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
PART B--FEDERAL-STATE COOPERATION
* * * * * * *
SEC. 319N. NATIONAL MEDICAL COUNTERMEASURE DISPENSING STRATEGY.
(a) Definitions.--In this section--
(1) the term ``appropriate committees of Congress''
means--
(A) the Committee on Homeland Security and
Governmental Affairs and the Committee on
Health, Education, Labor, and Pensions of the
Senate; and
(B) the Committee on Homeland Security, the
Committee on Energy and Commerce, and the
Committee on Oversight and Government Reform of
the House of Representatives;
(2) the term ``dispense'' means to provide medical
countermeasures to an affected population in response
to a threat or incident;
(3) the term ``medical countermeasure'' means a drug
(as that term is defined in section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act), a device (as
that term is defined in section 201(h) of such Act), or
a biological product (as that term is defined in
section 351 of this Act), to--
(A) diagnose, mitigate, prevent, or treat
harm from any biological agent (including
organisms that cause an infectious disease) or
toxin, chemical, radiological, or nuclear agent
that may cause a public health emergency; or
(B) diagnose, mitigate, prevent, or treat
harm from a condition that may result in
adverse health consequences or death and may be
caused by administering a drug, biological
product, or device; and
(4) the term ``public health emergency'' means a
public health emergency declared by the Secretary under
section 319.
(b) Strategy.--The Secretary, in coordination with the
Secretary of Homeland Security and the Postmaster General,
shall develop, coordinate, and maintain a National Medical
Countermeasure Dispensing Strategy (referred to in this section
as the ``National MCM Dispensing Strategy'').
(c) Contents.--The National MCM Dispensing Strategy shall--
(1) encompass all aspects of the Federal role in
dispensing medical countermeasures (referred to in this
section as ``MCMs'') and describe methods by which the
Federal Government may assist State, local, and tribal
governments to dispense MCMs;
(2) address a variety of geographical areas,
population densities, and demographics;
(3) create a multilayered approach for the dispensing
of MCMs that includes redundancies;
(4) address--
(A) a staffing plan for dispensing MCMs,
including--
(i) for MCM dispensing locations; and
(ii) for dispensing through the
United States Postal Service;
(B) requirements for timeliness of MCM
dispensing;
(C) appropriateness, effectiveness, and
efficiency of differing methods of MCM
dispensing;
(D) measures and evaluations of MCM
dispensing effectiveness and efficiency;
(E) liability issues associated with MCM
dispensing, considering--
(i) the volunteer force;
(ii) medical personnel;
(iii) potential adverse reactions to
medications;
(iv) participating employees of the
United States Postal Service; and
(v) security personnel;
(F) security issues, including--
(i) partnerships with law
enforcement; and
(ii) necessary levels of security to
protect MCM dispensing locations and
related personnel, participating
employees of the United States Postal
Service, and transportation of MCMs;
(G) communications issues, including--
(i) communications between the
Federal, State, local, and tribal
government officials that may be
involved in dispensing MCMs;
(ii) communications between the
government and private sector; and
(iii) the creation of prescripted
messages or message templates so that
information about how people can
acquire MCMs can be disseminated
quickly in anticipation of or in the
immediate aftermath of a biological
attack or a naturally occurring disease
outbreak;
(H) transportation of MCMs to dispensing
locations;
(I) implementation and operations of
dispensing plans;
(J) necessary levels of Federal technical
assistance in developing MCM dispensing
capabilities;
(K) measures that are necessary in order so
that actions taken pursuant to the National MCM
Dispensing Strategy will comply with applicable
requirements of the Federal Food, Drug, and
Cosmetic Act and of section 351 of this Act;
and
(L) any other topics that the Secretary
determines appropriate; and
(5) be exercised regularly in various jurisdictions.
(d) Coordination.--Where appropriate, the Secretary, in
coordination with the Secretary of Homeland Security and the
Postmaster General, shall coordinate with State, local, and
tribal government officials, private sector, and
nongovernmental organizations in development of the National
MCM Dispensing Strategy.
(e) Reports to Congress.--
(1) In general.--The Secretary, in coordination with
the Secretary of Homeland Security and the Postmaster
General, shall--
(A) not later than 180 days after the date of
enactment of this section, submit the National
MCM Dispensing Strategy to the appropriate
committees of Congress; and
(B) not later than 180 days after the
submission of the Strategy under subparagraph
(A), submit an implementation plan for such
Strategy to the appropriate committees of
Congress.
(2) Status report.--Not later than 1 year after the
submission of the implementation plan under paragraph
(1)(B), the Secretary, in coordination with the
Secretary of Homeland Security and the Postmaster
General, shall submit to the appropriate committees of
Congress a report describing the status of the
activities taken pursuant to the implementation plan.
PUBLIC HEALTH SERVICE ACT
* * * * * * *
SEC. 351A. [42 U.S.C. Sec. 262A] ENHANCED CONTROL OF DANGEROUS
BIOLOGICAL AGENTS AND TOXINS.
(a) Regulatory Control of Certain Biological Agents and
Toxins.--
(1) List of biological agents and toxins.--
(A) In general.--The Secretary shall by
regulation establish and maintain a list of
each biological agent and each toxin that has
the potential to pose a severe threat to public
health and safety.
(B) Criteria.--In determining whether to
include an agent or toxin on the list under
subparagraph (A), the Secretary shall--
(i) consider--
(I) the effect on human
health of exposure to the agent
or toxin;
(II) the degree of
contagiousness of the agent or
toxin and the methods by which
the agent or toxin is
transferred to humans;
(III) the suitability of the
agent or toxin to be used in a
biological attack;
[(III)] (IV) the availability
and effectiveness of
pharmacotherapies and
immunizations to treat and
prevent any illness resulting
from infection by the agent or
toxin; and
[(IV)] (V) any other
criteria, including the needs
of children and other
vulnerable populations, that
the Secretary considers
appropriate; and
(ii) consult with appropriate Federal
departments and agencies and with
scientific experts representing
appropriate professional groups,
including groups with pediatric
expertise.
(2) Tier i agents.--
(A) Designation of tier i agents.--Not later
than 180 days after the date of enactment of
the Weapons of Mass Destruction Prevention and
Preparedness Act of 2009, the Secretary, in
coordination with the Secretary of Homeland
Security, shall by regulation designate as a
`Tier I agents' those agents and toxins--
(i) for which the Secretary of
Homeland Security has issued a Material
Threat Determination under section
319F-2(c)(2) regarding the agent or
toxin, unless the Secretary of Health
and Human Services determines, in
coordination with the Secretary of
Homeland Security, that such
designation is unwarranted; or
(ii) that meet the criteria under
subparagraph (B).
(B) Criteria.--In determining whether to
designate an agent or toxin as a Tier I agent
under subparagraph (A), the Secretary, in
coordination with the Secretary of Homeland
Security, shall consider--
(i) whether the agent or toxin has
clear potential to be used effectively
in a biological attack that causes
significant casualties;
(ii) information available from any
biological or bioterrorism risk
assessments conducted by the Department
of Homeland Security or relevant
assessments by other agencies; and
(iii) such other criteria and
information that the Secretary
determines appropriate and relevant.
(C) Inclusion of agents and toxins not
previously listed.--All agents or toxins
designated by the Secretary as Tier I agents
shall be included on the list maintained by the
Secretary pursuant to paragraph (1).
(D) Evaluation of tier i agents.--The
Secretary, in coordination with the Secretary
of Homeland Security, shall--
(i) on an ongoing basis, consider the
inclusion of additional agents or
toxins on the list of Tier I agents, as
appropriate; and
(ii) at least biennially, review the
list of Tier I agents to determine
whether any agents or toxins should be
removed from the list.
[(2)] (3) Biennial review.--The Secretary shall
review and republish the [list under paragraph (1)]
lists under paragraphs (1) and (2) biennially, or more
often as needed, and shall by regulation revise the
[list as necessary in accordance with such paragraph]
lists as necessary in accordance with such paragraphs.
(b) * * *
(c) * * *
(d) Registration; Identification; Database.--
(1) Registration.--Regulations under subsections (b)
and (c) of this section shall require registration with
the Secretary of the possession, use, and transfer of
listed agents and toxins, and shall include provisions
to ensure that persons seeking to register under such
regulations have a lawful purpose to possess, use, or
transfer such agents and toxins, including provisions
in accordance with subsection (e)(6) of this section.
(2) Identification; database.--Regulations under
subsections (b) and (c) of this section shall require
that registration include (if available to the person
registering) information regarding the characterization
of listed agents and toxins to facilitate their
identification, including their source. The Secretary
shall maintain a national database that includes the
names and locations of registered persons, the listed
agents and toxins such persons are possessing, using,
or transferring, and information regarding the
characterization of such agents and toxins.
(3) Federal agency access.--The Secretary shall
ensure access to the database established pursuant to
paragraph (2) by the Secretary of Agriculture, the
Secretary of Homeland Security, the Attorney General,
the Secretary of Energy, the Secretary of Defense, and
any other Federal agency that the Secretary determines
appropriate.
(e) Safeguard and Security Requirements for Registered
Persons.--
(1) In general.--Regulations under subsections (b)
and (c) of this section shall include appropriate
safeguard and security requirements for persons
possessing, using, or transferring a listed agent or
toxin commensurate with the risk such agent or toxin
poses to public health and safety (including the risk
of use in domestic or international terrorism). The
Secretary shall establish such requirements in
collaboration with the Secretary of Homeland Security
and the Attorney General, and shall ensure compliance
with such requirements as part of the registration
system under such regulations.
(2) Limiting access to listed agents and toxins.--
Requirements under paragraph (1) shall include
provisions to ensure that registered persons--
(A) provide access to listed agents and
toxins to only those individuals whom the
registered person involved determines have a
legitimate need to handle or use such agents
and toxins;
(B) submit the names and other identifying
information for such individuals to the
Secretary and the Attorney General, promptly
after first determining that the individuals
need access under subparagraph (A), and
periodically thereafter while the individuals
have such access, not less frequently than once
every five years;
(C) deny access to such agents and toxins by
individuals whom the Attorney General has
identified as restricted persons; and
(D) limit or deny access to such agents and
toxins by individuals whom the Attorney General
has identified as within any category under
paragraph (3)(B)(ii), if limiting or denying
such access by the individuals involved is
determined appropriate by the Secretary, in
consultation with the Attorney General.
(3) Submitted names; use of databases by attorney
general.--
(A) In general.--Upon the receipt of names
and other identifying information under
paragraph (2)(B), the Attorney General shall,
for the sole purpose of identifying whether the
individuals involved are within any of the
categories specified in subparagraph (B),
promptly use criminal, immigration, national
security, and other electronic databases that
are available to the Federal Government and are
appropriate for such purpose. In identifying
whether an individual is within a category
specified in subparagraph (B)(ii)(II), the
Attorney General shall consult with the
Secretary of Homeland Security to determine if
the Department of Homeland Security possesses
any information relevant to the identification
of such an individual by the Attorney General.
(B) Certain individuals.--For purposes of
subparagraph (A), the categories specified in
this subparagraph regarding an individual are
that--
(i) the individual is a restricted
person; or
(ii) the individual is reasonably
suspected by any Federal law
enforcement or intelligence agency of--
(I) committing a crime set
forth in section 2332b(g)(5) of
title 18;
(II) knowing involvement with
an organization that engages in
domestic or international
terrorism (as defined in
section 2331 of such title 18)
or with any other organization
that engages in intentional
crimes of violence; or
(III) being an agent of a
foreign power (as defined in
section 1801 of title 50).
(C) Notification by attorney general
regarding submitted names.--After the receipt
of a name and other identifying information
under paragraph (2)(B), the Attorney General
shall promptly notify the Secretary whether the
individual is within any of the categories
specified in subparagraph (B).
(4) Notifications by secretary.--The Secretary, after
receiving notice under paragraph (3) regarding an
individual, shall promptly notify the registered person
involved of whether the individual is granted or denied
access under paragraph (2). If the individual is denied
such access, the Secretary shall promptly notify the
individual of the denial.
(5) Expedited review.--Regulations under subsections
(b) and (c) of this section shall provide for a
procedure through which, upon request to the Secretary
by a registered person who submits names and other
identifying information under paragraph (2)(B) and who
demonstrates good cause, the Secretary may, as
determined appropriate by the Secretary--
(A) request the Attorney General to expedite
the process of identification under paragraph
(3)(A) and notification of the Secretary under
paragraph (3)(C); and
(B) expedite the notification of the
registered person by the Secretary under
paragraph (4).
(6) Process regarding persons seeking to register.--
(A) Individuals.--Regulations under
subsections (b) and (c) of this section shall
provide that an individual who seeks to
register under either of such subsections is
subject to the same processes described in
paragraphs (2) through (4) as apply to names
and other identifying information submitted to
the Attorney General under paragraph (2)(B).
Paragraph (5) does not apply for purposes of
this subparagraph.
(B) Other persons.--Regulations under
subsections (b) and (c) of this section shall
provide that, in determining whether to deny or
revoke registration by a person other than an
individual, the Secretary shall submit the name
of such person to the Attorney General, who
shall use criminal, immigration, national
security, and other electronic databases
available to the Federal Government, as
appropriate for the purpose of promptly
notifying the Secretary whether the person, or,
where relevant, the individual who owns or
controls such person, is a restricted person or
is reasonably suspected by any Federal law
enforcement or intelligence agency of being
within any category specified in paragraph
(3)(B)(ii) (as applied to persons, including
individuals). Such regulations shall provide
that a person who seeks to register under
either of such subsections is subject to the
same processes described in paragraphs (2) and
(4) as apply to names and other identifying
information submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not
apply for purposes of this subparagraph. The
Secretary may exempt Federal, State, or local
governmental agencies from the requirements of
this subparagraph.
(7) Review.--
(A) Administrative review.--
(i) In general.--Regulations under
subsections (b) and (c) of this section
shall provide for an opportunity for a
review by the Secretary--
(I) when requested by the
individual involved, of a
determination under paragraph
(2) to deny the individual
access to listed agents and
toxins; and
(II) when requested by the
person involved, of a
determination under paragraph
(6) to deny or revoke
registration for such person.
(ii) Ex parte review.--During a
review under clause (i), the Secretary
may consider information relevant to
the review ex parte to the extent that
disclosure of the information could
compromise national security or an
investigation by any law enforcement
agency.
(iii) Final agency action.--The
decision of the Secretary in a review
under clause (i) constitutes final
agency action for purposes of section
702 of title 5.
(B) Certain procedures.--
(i) Submission of ex parte materials
in judicial proceedings.--When
reviewing a decision of the Secretary
under subparagraph (A), and upon
request made ex parte and in writing by
the United States, a court, upon a
sufficient showing, may review and
consider ex parte documents containing
information the disclosure of which
could compromise national security or
an investigation by any law enforcement
agency. If the court determines that
portions of the documents considered ex
parte should be disclosed to the person
involved to allow a response, the court
shall authorize the United States to
delete from such documents specified
items of information the disclosure of
which could compromise national
security or an investigation by any law
enforcement agency, or to substitute a
summary of the information to which the
person may respond. Any order by the
court authorizing the disclosure of
information that the United States
believes could compromise national
security or an investigation by any law
enforcement agency shall be subject to
the processes set forth in
subparagraphs (A) and (B)(i) of section
2339B(f)(5) of title 18 (relating to
interlocutory appeal and expedited
consideration).
(ii) Disclosure of information.--In a
review under subparagraph (A), and in
any judicial proceeding conducted
pursuant to such review, neither the
Secretary nor the Attorney General may
be required to disclose to the public
any information that under [subsection
(h)] subsection (i) of this section
shall not be disclosed under section
552 of title 5.
(8) Notifications regarding theft or loss of
agents.--Requirements under paragraph (1) shall include
the prompt notification of the Secretary, and
appropriate Federal, State, and local law enforcement
agencies, of the theft or loss of listed agents and
toxins.
(9) Technical assistance for registered persons.--The
Secretary, in consultation with the Attorney General,
may provide technical assistance to registered persons
to improve security of the facilities of such persons.
(f) Laboratory and Facility Registration and Database.--
(1) In general.--The Secretary, in coordination with
the Secretary of Homeland Security and the Secretary of
Agriculture, shall by regulation establish criteria
defining characteristics, features, or equipment that
could facilitate the misuse of a laboratory or other
facility for the purposes of developing a biological
weapon, which may include--
(A) technology that is particularly suitable
to the development of an effective biological
weapon, such as technology that would enable
synthesis of Tier I agents;
(B) features that would enable an individual
to develop a biological weapon while escaping
detection; and
(C) such other characteristics as the
Secretary determines appropriate.
(2) Registry agents.--
(A) In general.--The Secretary, in
coordination with the Secretary of Agriculture
and the Secretary of Homeland Security, shall
establish and maintain by regulation a list of
biological agents and toxins that have the
potential to pose a severe threat to public,
animal, or plant health but for which the
potential to be used in a biological attack has
not been established.
(B) Designation.--Agents listed pursuant to
subparagraph (A) shall be designated as
``Registry Agents''.
(C) Exclusion of select agents.--In
determining whether to designate a biological
agent or toxin as a Registry Agent, the
Secretary shall exclude agents or toxins listed
pursuant to subsection (a)(1) of this section
and section 212(a)(1) of the Agricultural
Bioterrorism Protection Act of 2002.
(3) Regulations governing registration and
database.--
(A) Regulations requiring registration.--The
Secretary shall by regulation require the
registration with the Secretary of laboratories
or other facilities that--
(i) meet the criteria established
pursuant to paragraph (1); or
(ii) possess, use, or transfer
Registry Agents designated under
paragraph (2).
(B) Database.--The Secretary shall maintain a
national database that includes the locations
of each laboratory or other facility required
to be registered under this subsection, the
criteria established pursuant to paragraph (1)
that are applicable to the laboratory or
facility, the Registry Agents that are
possessed or used at or transferred by the
laboratory or facility, and the name of the
person that owns or controls the laboratory or
facility.
(C) Additional registration requirements.--An
individual who possesses, uses, or transfers
Registry Agents at a location other than a
laboratory or other facility shall be required
to register with the Secretary pursuant to this
subsection.
(4) Penalties.--In addition to any other penalties
that may apply under law, any person who violates any
provision of this subsection shall be subject to the
United States for a civil penalty in an amount not to
exceed $25,000 in the case of an individual and $50,000
in the case of any other person.
(5) Access to database.--The Secretary shall make the
database established under paragraph (3) available to
the Secretary of Homeland Security, the Secretary of
Agriculture, the Secretary of Defense, the Attorney
General, and such agencies as the Secretary determines
appropriate.
(6) Biosecurity and biosafety best practices.--The
Secretary, in consultation with the Secretary of
Homeland Security and the Secretary of Agriculture,
shall promote biosecurity and biosafety best practices
to entities registered under paragraph (3).
(7) Disclosure of information.--No Federal agency
shall disclose under section 552 of title 5, United
States Code, any information contained in the database
established pursuant to paragraph (3).
[(f)] (g) Inspections.--The Secretary shall have the
authority to inspect persons subject to regulations under
subsection (b) or (c) of this section to ensure their
compliance with such regulations, including prohibitions on
restricted persons and other provisions of subsection (e) of
this section.
[(g)] (h) Exemptions.--
(1) Clinical or diagnostic laboratories.--Regulations
under [subsections (b) and (c)] subsections (b), (c),
and (f) of this section shall exempt clinical or
diagnostic laboratories and other persons who possess,
use, or transfer listed agents or toxins that are
contained in specimens presented for diagnosis,
verification, or proficiency testing, provided that--
(A) the identification of such agents or
toxins is reported to the Secretary, and when
required under Federal, State, or local law, to
other appropriate authorities; and
(B) such agents or toxins are transferred or
destroyed in a manner set forth by the
Secretary by regulation.
(2) Products.--
(A) In general.--Regulations under
subsections (b) and (c) of this section shall
exempt products that are, bear, or contain
listed agents or toxins and are cleared,
approved, licensed, or registered under any of
the Acts specified in subparagraph (B), unless
the Secretary by order determines that applying
additional regulation under subsection (b) or
(c) of this section to a specific product is
necessary to protect public health and safety.
(B) Relevant laws.--For purposes of
subparagraph (A), the Acts specified in this
subparagraph are the following:
(i) The Federal Food, Drug, and
Cosmetic Act [21 U.S.C. Sec. Sec. 301
et seq.].
(ii) Section 262 of this title.
(iii) The Act commonly known as the
Virus-Serum-Toxin Act (the eighth
paragraph under the heading ``Bureau of
Animal Industry'' in the Act of March
4, 1913; 21 U.S.C. Sec. Sec. 151-159).
(iv) The Federal Insecticide,
Fungicide, and Rodenticide Act [7
U.S.C. Sec. Sec. 136 et seq.].
(C) Investigational use.--
(i) In general.--The Secretary may
exempt an investigational product that
is, bears, or contains a listed agent
or toxin from the applicability of
provisions of regulations under
subsection (b) or (c) of this section
when such product is being used in an
investigation authorized under any
Federal Act and the Secretary
determines that applying additional
regulation under subsection (b) or (c)
of this section to such product is not
necessary to protect public health and
safety.
(ii) Certain processes.--Regulations
under subsections (b) and (c) of this
section shall set forth the procedures
for applying for an exemption under
clause (i). In the case of
investigational products authorized
under any of the Acts specified in
subparagraph (B), the Secretary shall
make a determination regarding a
request for an exemption not later than
14 days after the first date on which
both of the following conditions have
been met by the person requesting the
exemption:
(I) The person has submitted
to the Secretary an application
for the exemption meeting the
requirements established by the
Secretary.
(II) The person has notified
the Secretary that the
investigation has been
authorized under such an Act.
(3) Public health emergencies.--The Secretary may
temporarily exempt a person from the applicability of
the requirements of this section, in whole or in part,
if the Secretary determines that such exemption is
necessary to provide for the timely participation of
the person in a response to a domestic or foreign
public health emergency (whether determined under
section 247d(a) of this title or otherwise) that
involves a listed agent or toxin. With respect to the
emergency involved, such exemption for a person may not
exceed 30 days, except that the Secretary, after review
of whether such exemption remains necessary, may
provide one extension of an additional 30 days.
(4) Agricultural emergencies.--Upon request of the
Secretary of Agriculture, after the granting by such
Secretary of an exemption under section 8401(g)(1)(D)
of title 7 pursuant to a finding that there is an
agricultural emergency, the Secretary of Health and
Human Services may temporarily exempt a person from the
applicability of the requirements of this section, in
whole or in part, to provide for the timely
participation of the person in a response to the
agricultural emergency. With respect to the emergency
involved, the exemption under this paragraph for a
person may not exceed 30 days, except that upon request
of the Secretary of Agriculture, the Secretary of
Health and Human Services may, after review of whether
such exemption remains necessary, provide one extension
of an additional 30 days.
[(h)] (i) Disclosure of information.--
(1) Nondisclosure of certain information.--No Federal
agency specified in paragraph (2) shall disclose under
section 552 of title 5 any of the following:
(A) Any registration or transfer
documentation submitted under subsections (b)
and (c) of this section for the possession,
use, or transfer of a listed agent or toxin; or
information derived therefrom to the extent
that it identifies the listed agent or toxin
possessed, used, or transferred by a specific
registered person or discloses the identity or
location of a specific registered person.
(B) The national database developed pursuant
to subsection (d) of this section, or any other
compilation of the registration or transfer
information submitted under subsections (b) and
(c) of this section to the extent that such
compilation discloses site-specific
registration or transfer information.
(C) Any portion of a record that discloses
the site-specific or transfer-specific
safeguard and security measures used by a
registered person to prevent unauthorized
access to listed agents and toxins.
(D) Any notification of a release of a listed
agent or toxin submitted under subsections (b)
and (c) of this section, or any notification of
theft or loss submitted under such subsections.
(E) Any portion of an evaluation or report of
an inspection of a specific registered person
conducted under [subsection (f)] subsection (g)
of this section that identifies the listed
agent or toxin possessed by a specific
registered person or that discloses the
identity or location of a specific registered
person if the agency determines that public
disclosure of the information would endanger
public health or safety.
(2) Covered agencies.--For purposes of paragraph (1)
only, the Federal agencies specified in this paragraph
are the following:
(A) The Department of Health and Human
Services, the Department of Justice, the
Department of Agriculture, and the Department
of Transportation.
(B) Any Federal agency to which information
specified in paragraph (1) is transferred by
any agency specified in subparagraph (A) of
this paragraph.
(C) Any Federal agency that is a registered
person, or has a sub-agency component that is a
registered person.
(D) Any Federal agency that awards grants or
enters into contracts or cooperative agreements
involving listed agents and toxins to or with a
registered person, and to which information
specified in paragraph (1) is transferred by
any such registered person.
(3) Other exemptions.--This subsection may not be
construed as altering the application of any exemptions
to public disclosure under section 552 of title 5,
except as to subsection 552(b)(3) of such title, to any
of the information specified in paragraph (1).
(4) Rule of construction.--Except as specifically
provided in paragraph (1), this subsection may not be
construed as altering the authority of any Federal
agency to withhold under section 552 of title 5, or the
obligation of any Federal agency to disclose under
section 552 of title 5, any information, including
information relating to--
(A) listed agents and toxins, or individuals
seeking access to such agents and toxins;
(B) registered persons, or persons seeking to
register their possession, use, or transfer of
such agents and toxins;
(C) general safeguard and security policies
and requirements under regulations under
subsections (b) and (c) of this section; or
(D) summary or statistical information
concerning registrations, registrants, denials
or revocations of registrations, listed agents
and toxins, inspection evaluations and reports,
or individuals seeking access to such agents
and toxins.
(5) Disclosures to congress; other disclosures.--This
subsection may not be construed as providing any
authority--
(A) to withhold information from the Congress
or any committee or subcommittee thereof; or
(B) to withhold information from any person
under any other Federal law or treaty.
[(i)] (j) Civil Money Penalty.--
(1) In general.--In addition to any other penalties
that may apply under law, any person who violates any
provision of regulations under subsection (b) or (c) of
this section shall be subject to the United States for
a civil money penalty in an amount not exceeding
$250,000 in the case of an individual and $500,000 in
the case of any other person.
(2) Applicability of certain provisions.--The
provisions of section 1320a-7a of this title (other
than subsections (a), (b), (h), and (i), the first
sentence of subsection (c), and paragraphs (1) and (2)
of subsection (f)) shall apply to a civil money penalty
under paragraph (1) in the same manner as such
provisions apply to a penalty or proceeding under
section 1320a-7a(a) of this title. The Secretary may
delegate authority under this subsection in the same
manner as provided in section 1320a-7a(j)(2) of this
title, and such authority shall include all powers as
contained in section 6 of the Inspector General Act of
1978 (5 U.S.C. App.).
[(j)] (k) Notification In Event of Release.--Regulations
under subsections (b) and (c) of this section shall require the
prompt notification of the Secretary by a registered person
whenever a release, meeting criteria established by the
Secretary, of a listed agent or toxin has occurred outside of
the biocontainment area of a facility of the registered person.
Upon receipt of such notification and a finding by the
Secretary that the release poses a threat to public health or
safety, the Secretary shall take appropriate action to notify
relevant State and local public health authorities, other
relevant Federal authorities, and, if necessary, other
appropriate persons (including the public). If the released
listed agent or toxin is an overlap agent or toxin (as defined
in [subsection (l)] subsection m of this section), the
Secretary shall promptly notify the Secretary of Agriculture
upon notification by the registered person.
[(k)] (l) Reports.--The Secretary shall report to the
Congress annually on the number and nature of notifications
received under subsection (e)(8) of this section (relating to
theft or loss) and [subsection (j)] subsection (k) of this
section (relating to releases).
[(l)] (m) Definitions.--For purposes of this section:
(1) The terms ``biological agent'' and ``toxin'' have
the meanings given such terms in section 178 of title
18.
(2) The term ``listed agents and toxins'' means
biological agents and toxins listed pursuant to
subsection (a)(1) of this section.
(3) The term ``listed agents or toxins'' means
biological agents or toxins listed pursuant to
subsection (a)(1) of this section.
(4) The term ``overlap agents and toxins'' means
biological agents and toxins that--
(A) are listed pursuant to subsection
(a)(1) of this section; and
(B) are listed pursuant to section
8401(a)(1) of title 7.
(5) The term ``overlap agent or toxin'' means a
biological agent or toxin that--
(A) is listed pursuant to subsection
(a)(1) of this section; and
(B) is listed pursuant to section
8401(a)(1) of title 7.
(6) The term ``person'' includes Federal, State, and
local governmental entities.
(7) The term ``registered person'' means a person
registered under regulations under subsection (b) or
(c) of this section.
(8) The term ``restricted person'' has the meaning
given such term in section 175b of title 18.
[(m)] (n) Authorization of appropriations.--For the purpose
of carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2007.
HOMELAND SECURITY ACT OF 2002
Public Law 107-296
* * * * * * *
TITLE II--INFORMATION ANALYSIS AND INFRASTRUCTURE PROTECTION
Subtitle A--Directorate For Information Analysis And Infrastructure
Protection; Access To Information
* * * * * * *
SEC. 201. [6 U.S.C. Sec. 121] INFORMATION AND ANALYSIS AND
INFRASTRUCTURE PROTECTION.
(a) * * *
* * * * * * *
(d) Responsibilities of Secretary Relating to Intelligence
and Analysis and Infrastructure Protection.--
(1) * * *
* * * * * * *
(8) To disseminate, as appropriate, information
analyzed by the Department within the Department, to
other agencies of the Federal Government with
responsibilities relating to homeland security, [and to
agencies of State and local governments and private
sector entities with such responsibilities in order to
assist in the deterrence, prevention, preemption of, or
response to, terrorist attacks against the United
States.] to State, local, tribal, and private entities
with such responsibilities, and, as appropriate, to the
general public, in order to assist in deterring,
preventing, or responding to acts of terrorism against
the United States.
* * * * * * *
SEC. 203. [6 U.S.C. Sec. 124] HOMELAND SECURITY ADVISORY SYSTEM.
(a) * * *
(b) * * *
(c) Terrorism Threat Awareness.--
(1) Terrorism threat awareness.--The Secretary, in
coordination with the Attorney General, shall ensure
that information concerning terrorist threats is
available to the general public within the United
States.
(2) Threat bulletins.--
(A) In general.--Consistent with the
requirements of subsection (b), the Secretary
shall on a timely basis prepare unclassified
terrorism related threat and risk assessments.
(B) Requirements.--Each assessment required
under subparagraph (A) shall--
(i) include guidelines for the
general public for preventing and
responding to acts of terrorism; and
(ii) be made available on the website
of the Department and other publicly
accessible websites, communication
systems, and information networks.
(3) Guidelines for state, local, and tribal
governments.--The Secretary shall provide to State,
local, and tribal governments written guidelines on how
to disseminate information about terrorism-related
threats and risks to the general public within their
jurisdictions.
(4) Use of existing resources.--The Secretary shall
use websites, communication systems, and information
networks in operation on the date of an assessment
under this subsection to satisfy the requirements of
paragraph (2)(B)(ii).
* * * * * * *
TITLE III--SCIENCE AND TECHNOLOGY IN SUPPORT OF HOMELAND SECURITY
* * * * * * *
SEC. 318. ENHANCED BIOSECURITY MEASURES.
(a) Definitions.--In this section:
(1) Listed agent.--The term `listed agent' means an
agent or toxin included on--
(A) the list established and maintained by
the Secretary of Health and Human Services
under section 351A(a)(1) of the Public Health
Service Act (42 U.S.C. Sec. 262a(a)(1)); or
(B) the list established and maintained by
the Secretary of Agriculture under section
212(a)(1) of the Agricultural Bioterrorism
Protection Act of 2002 (7 U.S.C.
Sec. 8401(a)(1)).
(2) Person.--The term `person' has the meaning given
that term in section 351A(l)(6) of the Public Health
Service Act (42 U.S.C. Sec. 262a(l)(6)).
(3) Tier i agent.--The term `Tier I agent' means an
agent or toxin designated as a Tier I agent under
section 351A(a)(2) of the Public Health Service Act (42
U.S.C. Sec. 262a(a)(2)) or section 212(a)(2) of the
Agricultural Bioterrorism Protection Act of 2002 (7
U.S.C. Sec. 8401(a)(2)).
(b) Regulations.--The Secretary, in consultation with the
Secretary of Health and Human Services and the Secretary of
Agriculture, shall through a negotiated rule making under
subchapter III of chapter 5 of title 5, United States Code,
establish enhanced biosecurity measures for persons that
possess, use, or transfer Tier I agents, which shall include--
(1) standards for personnel reliability programs;
(2) standards for biosecurity training of responsible
officials, laboratory personnel, and support personnel
employed by such persons;
(3) standards for performing laboratory risk
assessments;
(4) risk-based laboratory security performance
standards; and
(5) any other security standards jointly determined
necessary by the Secretary and the Secretary of Health
and Human Services.
(c) Negotiated Rulemaking Committee.--The negotiated
rulemaking committee established by the Secretary under
subsection (b) shall include representatives from--
(1) the Department;
(2) the Department of Health and Human Services;
(3) the Department of Agriculture;
(4) the Department of Defense;
(5) the Department of Energy;
(6) the Department of Justice;
(7) for profit research institutions;
(8) academic research institutions;
(9) nonprofit research institutions; and
(10) other interested parties, as the Secretary
determines appropriate.
(d) Time Requirement.--The procedures for the negotiated
rulemaking conducted under subsection (b) shall be conducted in
a timely manner to ensure that--
(1) any recommendations with respect to proposed
regulations are provided to the Secretary not later
than 6 months after the date of enactment of this
section; and
(2) a final rule is promulgated not later than 12
months after the date of enactment of this section.
(e) Factors To Be Considered.--In developing proposed and
final standards under subsection (b), the Secretary and the
negotiated rulemaking committee shall consider factors
including--
(1) the recommendations of the Commission on the
Prevention of Weapons of Mass Destruction Proliferation
and Terrorism (established under section 1851 of the
Implementing Recommendations of the 9/11 Commission Act
of 2007 (Public Law 110-53; 121 Stat. 501)), the
National Science Advisory Board for Biosecurity
(established under section 205 of the Pandemic and All-
Hazards Preparedness Act (Public Law 109-417; 120 Stat.
2851)), the Trans-Federal Task Force on Optimizing
Biosafety and Biocontainment Oversight, and any working
group established under Executive Order 13486 (74 Fed.
Reg. 2289) relating to strengthening laboratory
biosecurity; and
(2) how any disincentives to biological research
arising from enhanced biosecurity measures can be
minimized.
(f) Implementation of Enhanced Biosecurity Measures.--
(1) Enforcement.--The Secretary, in consultation as
appropriate with the Secretary of Health and Human
Services and the Secretary of Agriculture, shall
enforce the standards promulgated under subsection (b).
(2) Training programs.--The Secretary of Health and
Human Services, in consultation with the Secretary,
shall develop or approve training programs that meet
the standards promulgated under subsection (b).
(3) Harmonization of regulations.--
(A) Regulations under public health service
act.--Not later than 120 days after the
Secretary promulgates regulations or amendments
thereto pursuant to this section, the Secretary
of Health and Human Services shall amend
regulations promulgated under the Select Agent
Program under section 351A(b)(1) of the Public
Health Service Act (42 U.S.C. Sec. 262a(b)(1))
to ensure that such regulations do not overlap
or conflict with the regulations promulgated by
the Secretary under this section.
(B) Regulations under agriculture
bioterrorism protection act of 2002.--Not later
than 120 days after the Secretary promulgates
regulations or amendments thereto pursuant to
this section, the Secretary of Agriculture
shall amend regulations promulgated under the
Select Agent Program under section 212(b)(1) of
the Agricultural Bioterrorism Protection Act of
2002 (7 U.S.C. Sec. 8401(b)(1)) to ensure that
such regulations do not overlap or conflict
with the regulations promulgated by the
Secretary under this section.
(4) Penalties.--
(A) Civil money penalty.--In addition to any
other penalties that may apply under law, any
person who violates any provision of
regulations promulgated under subsection (b)
shall be subject to a civil money penalty in an
amount not exceeding $250,000 in the case of an
individual and $500,000 in the case of any
other person that possesses, uses, or transfers
a Tier I agent.
(B) Intermediate sanctions.--
(i) In general.--If the Secretary
determines that a person has violated
any provision of regulations
promulgated under this section, the
Secretary may impose intermediate
sanctions in lieu of the actions
authorized by subsection (A).
(ii) Types of sanctions.--The
intermediate sanctions which may be
imposed under paragraph (1) shall
consist of--
(I) directed plans of
correction;
(II) civil money penalties in
an amount not to exceed $10,000
for each violation of, or for
each day of substantial
noncompliance with, the
regulations promulgated under
this section;
(III) payment for the costs
of onsite monitoring; or
(IV) any combination of the
actions described in subclauses
(I), (II), and (III).
(C) Suspension of research and funding.--
(i) In general.--If the Secretary
determines that a person has violated
any provision of the regulations
promulgated under subsection (b) and
that the violation has endangered
security, the Secretary may suspend the
authority of the person to possess,
use, or transfer Tier I agents until
the violation has been remedied.
(ii) Notice.--If the Secretary
suspends the authority of a person to
possess, use, or transfer Tier I agents
under clause (i), the Secretary shall
notify each executive agency that
provides funding for research on Tier I
agents by the person.
(iii) Suspension.--If the head of an
executive agency receives notice under
clause (ii), the head of the executive
agency may suspend the provision of
funds to the person for research on
Tier I agents.
(iv) Rule of construction.--Nothing
in this subparagraph shall be construed
to limit or modify the authority to
suspend the authority of a person to
possess, use, or transfer Tier I
agents, or to suspend funding for
research under any other provision of
law.
(D) Procedures.--The Secretary shall develop
and implement procedures with respect to when
and how penalties or intermediate sanctions are
to be imposed under this paragraph. Such
procedures shall provide for notice to the
person, a reasonable opportunity to respond to
the proposed penalty or intermediate sanction,
and appropriate procedures for appealing
determinations relating to the imposition of a
penalty or intermediate sanction.
(5) Simultaneous laboratory inspections.--
(A) Inspections by the department of homeland
security.--The Secretary shall have the
authority to inspect persons subject to the
regulations promulgated under subsection (b) to
ensure compliance with the regulations by such
persons.
(B) Simultaneous inspections.--All Federal
agencies conducting inspections of a person to
ensure compliance with regulations promulgated
under subsection (b), regulations promulgated
under section 351A(b)(1) of the Public Health
Service Act (42 U.S.C. Sec. 262a(b)(1)),
regulations promulgated under section 212(b)(1)
of the Agricultural Bioterrorism Protection Act
of 2002 (7 U.S.C. Sec. 8401(b)(1)), or security
standards applicable under a contract between a
Federal agency and the person shall be
conducted simultaneously to the extent
practicable.
(C) Joint inspection procedures.--Federal
agencies conducting simultaneous inspections of
a person under this paragraph shall cooperate,
to the maximum extent practicable, to ensure
that the inspections are conducted efficiently
and in a manner that minimizes the
administrative burden on the person.
(D) Inspection reports.--Any report of
inspection of a person conducted by a Federal
agency to enforce regulations promulgated under
subsection (b), regulations promulgated under
section 351A(b)(1) of the Public Health Service
Act (42 U.S.C. Sec. 262a(b)(1)), regulations
promulgated under section 212(b)(1) of the
Agricultural Bioterrorism Protection Act of
2002 (7 U.S.C. Sec. 8401(b)(1)), or security
standards applicable under a contract between
the Federal agency and the person shall be made
available to any other Federal agency that
enforces any such regulations with respect to
the person or that funds research of a Tier I
agent or a listed agent by the person.
SEC. 319. BIOSECURITY INFORMATION SHARING.
(a) In General.--Consistent with the responsibilities under
section 201(d), the Secretary shall ensure that State, local,
and tribal governments have access to relevant safety and
security information relating to biological laboratories and
facilities in or in close proximity to the jurisdiction of the
State, local, or tribal government, as the Secretary determines
appropriate.
(b) Access to Information in Databases.--In carrying out
this section, the Secretary may utilize information from the
national databases established under subsections (d)(2) and
(f)(3) of section 351A of the Public Health Service Act (42
U.S.C. Sec. 262a) and section 212(d)(2) of the Agricultural
Bioterrorism Protection Act of 2002 (7 U.S.C. Sec. 8401(d)(2)).
(c) Classified and Sensitive Information.--The Secretary
shall ensure that any information disseminated under this
section is disseminated consistent with--
(1) the authority of the Director of National
Intelligence to protect intelligence sources and
methods under the National Security Act of 1947 (50
U.S.C. Sec. Sec. 401 et seq.) and related procedures or
similar authorities of the Attorney General concerning
sensitive law enforcement information;
(2) section 552a of title 5, United States Code
(commonly referred to as the Privacy Act of 1974); and
(3) other relevant laws.
SEC. 320. PERSONAL MEDKITS FOR EMERGENCY RESPONSE PROVIDERS AND MEMBERS
OF PREPAREDNESS ORGANIZATIONS.
(a) Definitions.--In this section--
(1) the term `appropriate committees of Congress'
means--
(A) the Committee on Homeland Security and
Governmental Affairs and the Committee on
Health, Education, Labor, and Pensions of the
Senate; and
(B) the Committee on Homeland Security and
the Committee on Energy and Commerce of the
House of Representatives;
(2) the term `immediate family member' means an
individual who is a cohabitating family member or
domestic partner;
(3) the term `preparedness organization' means an
organization that contributes to State or local
preparedness for an emergency or major disaster (as
those terms are defined in section 102 of the Robert T.
Stafford Disaster Relief and Emergency Assistance Act
(42 U.S.C. Sec. 5122)), including Community Emergency
Response Teams, the Medical Reserve Corps, the Fire
Corps, and the citizen preparedness programs of the
American Red Cross;
(4) the term `medkit' means a cache of antibiotics
and other medical countermeasures to be used during a
public health emergency;
(5) the term `medkit program' means the program
established under subsection (b); and
(6) the term `public health emergency' means a public
health emergency declared by the Secretary of Health
and Human Services under section 319 of the Public
Health Service Act (42 U.S.C. Sec. 247d).
(b) Establishment.--The Secretary, in coordination with the
Secretary of Health and Human Services and in a manner that
complies with applicable requirements of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. Sec. Sec. 301 et seq.) and of
section 351 of the Public Health Service Act (42 U.S.C.
Sec. 262), shall establish a program to distribute medkits to
emergency response providers, members of preparedness
organizations, and immediate family members of an emergency
response provider or member of a preparedness organization.
(c) Medkit Program Components.--
(1) In general.--An emergency response provider,
member of a preparedness organization, or immediate
family member of an emergency response provider or
member of a preparedness organization participating in
the medkit program shall--
(A) register with the Secretary;
(B) before the distribution of a medkit,
receive training regarding--
(i) the proper use and dosing of
medical countermeasures;
(ii) reporting of the use of a
medkit;
(iii) the proper storage of a medkit;
and
(iv) any other topic determined
appropriate by the Secretary;
(C) before the distribution of a medkit,
undergo appropriate medical screening; and
(D) report the use of a medkit within a
reasonable time period, as established by the
Secretary.
(2) Inventory.--The Secretary shall conduct an annual
inventory of medkits distributed under the medkit
program.
(d) Authorization and Contents.--
(1) In general.--The Secretary shall coordinate with
the Secretary of Health and Human Services and the
Commissioner of Food and Drugs to--
(A) seek an emergency use authorization under
section 564 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. Sec. Sec. 360bbb-3), if
needed, to allow distribution and use of
medkits under the medkit program; and
(B) establish the appropriate contents for
medkits distributed under the medkit program.
(2) Content consideration.--In establishing the
appropriate contents for medkits under paragraph 20
(1)(B), the Secretary, in coordination with the
Secretary of Health and Human Services, shall--
(A) consider information available from any
biological or bioterrorism risk assessments
conducted by the Department of Homeland
Security or other relevant assessments by other
departments or the intelligence community;
(B) consider the criteria described in
section 351A(a)(1)(B) of the Public Health
Service Act (42 U.S.C. Sec. 262a(a)(1)(B));
(C) consult with relevant private and public
organizations; and
(D) consider such other criteria and
information that the Secretary, in coordination
with the Secretary of Health and Human
Services, determines appropriate.
(e) Report.--Not later than 180 days after the date of
enactment of this section, the Secretary shall submit to the
appropriate committees of Congress a report on the
implementation of this section.
(f) Authorization of Appropriations.--There is authorized
to be appropriated to the Secretary to carry out this section,
$20,000,000 for each of fiscal years 2011 through 2013.
SEC. 321. BIOFORENSICS CAPABILITIES AND STRATEGY.
(a) Definitions.--In this section--
(1) the term `appropriate committees of Congress'
means--
(A) the Committee on Homeland Security and
Governmental Affairs, the Committee on the
Judiciary, the Committee on Health, Education,
Labor, and Pensions, the Committee on
Agriculture, Nutrition, and Forestry, and the
Committee on Armed Services of the Senate; and
(B) the Committee on Homeland Security, the
Committee on the Judiciary, the Committee on
Energy and Commerce, the Committee on
Agriculture, and the Committee on Armed
Services of the House of Representatives;
(2) the term `bioforensic' means the scientific
discipline dedicated to analyzing evidence from a
bioterrorism act, biological agent or toxin based
criminal act, or inadvertent biological agent or toxin
release for attribution purposes;
(3) the term `National Bioforensics Analysis Center'
means the National Bioforensics Analysis Center
established under subsection (b);
(4) the term `national bioforensics repository
collection' means the national bioforensics repository
collection established under subsection (c)(1); and
(5) the term `national bioforensics strategy' means
the national bioforensics strategy developed under
subsection (d)(1).
(b) National Bioforensics Analysis Center.--There is in the
Department a National Bioforensics Analysis Center which
shall--
(1) serve as the lead Federal facility to conduct and
facilitate bioforensic analysis in support of the
executive agency with primary responsibility for
responding to the biological incident;
(2) maintain the national bioforensics repository
collection as a reference collection of biological
agents and toxins for comparative bioforensic
identifications; and
(3) support threat agent characterization studies and
bioforensic assay development.
(c) National Bioforensic Repository Collection.--
(1) In general.--The National Bioforensics Analysis
Center shall maintain a national bioforensics
repository collection.
(2) Activities.--The national bioforensics repository
collection shall--
(A) receive, store, and distribute biological
threat agents and toxins and related biological
agents and toxins;
(B) serve as a reference collection for
comparative bioforensic identifications; and
(C) support threat agent characterization
studies and bioforensic assay development.
(3) Participation.--
(A) In general.--The Secretary, the Attorney
General, the Secretary of Health and Human
Services, the Secretary of Agriculture, the
Secretary of Defense, and the head of any other
appropriate executive agency with a biological
agent or toxin collection that is useful for
the bioforensic analysis of biological
incidents, performance of biological threat
agent characterization studies, or development
of bioforensic assays shall provide samples of
relevant biological agents and toxins, as
determined by the Secretary, in consultation
with the head of the executive agency
possessing the agent or toxin, which shall not
include any variola virus, to the national
bioforensics repository collection.
(B) Other biological agents and toxins.--The
Secretary shall encourage the contribution of
public and private biological agent and toxin
collections to the national bioforensics
repository collection that were collected or
created with support from a Federal grant or
contract and that support the functions
described in paragraph (2).
(4) Access.--The Secretary shall--
(A) provide an executive agency that submits
a biological agent or toxin to the national
bioforensics repository collection with access
to the national bioforensics repository
collection; and
(B) establish a mechanism to provide public
and private entities with access to the
national bioforensics repository collection, as
appropriate, for scientific analysis of a
biological agent or toxin in the national
bioforensics repository collection, with
appropriate protection for intellectual
property rights.
(5) Report.--
(A) In general.--Not later than 180 days
after the date of enactment of this section,
the Secretary, in consultation with the
Attorney General, the Secretary of Health and
Human Services, the Secretary of Agriculture,
the Secretary of Defense, and the head of any
other appropriate executive agency that will
participate in or contribute to the national
bioforensics repository collection, shall
submit to the appropriate committees of
Congress a report regarding the national
bioforensics repository collection.
(B) Contents.--The report submitted under
subparagraph (A) shall--
(i) discuss the status of the
establishment of the national
bioforensics repository collection;
(ii) identify domestic and
international biological agent and
toxin collections that would prove
useful in carrying out the functions of
the national bioforensics repository
collection;
(iii) examine any access or
participation issues affecting the
establishment of the national
bioforensics repository collection or
the ability to support bioforensic
analysis, threat characterization
studies, or bioforensic assay
development, including--
(I) intellectual property
concerns;
(II) access to collected or
created biological agent or
toxin collections funded by a
Federal grant or contract;
(III) costs for the national
bioforensics repository
collection associated with
accessing domestic and
international biological agent
and toxin collections;
(IV) costs incurred by
domestic and international
biological agent and toxin
collections to allow broad
access or contribute biological
agents or toxins to the
national bioforensics
repository collection; and
(V) access to the national
bioforensics repository
collection by public and
private researchers to support
threat characterization studies
and bioforensic assay
development; and
(iv) other issues determined
appropriate by the Secretary.
(d) National Bioforensic Strategy.--
(1) In general.--The Secretary, in coordination with
the Attorney General, the Secretary of Health and Human
Services, the Secretary of Agriculture, the Secretary
of Defense, and the head of any other appropriate
executive agency, as determined by the Secretary, shall
develop, coordinate, and maintain a national
bioforensics strategy.
(2) Contents.--The national bioforensics strategy
shall--
(A) provide for a coordinated approach across
all executive agencies with responsibilities
for analyzing evidence from a bioterrorism act,
biological agent or toxin based criminal act,
or inadvertent biological agent or toxin
release for attribution purposes;
(B) describe the roles and responsibilities
of all relevant executive agencies;
(C) establish mechanisms, in coordination
with State, local, and tribal governments, for
coordinating with law enforcement agencies in
analyzing bioforensic evidence;
(D) include guidance for collecting,
processing, and analyzing samples; and
(E) provide for a coordinated approach across
all executive agencies to support threat agent
characterization research, funding, and assay
development.
(3) Report.--Not later than 180 days after the date
of enactment of this section, the Secretary, in
consultation with the Attorney General, the Secretary
of Health and Human Services, the Secretary of
Agriculture, the Secretary of Defense, and the head of
any other appropriate executive agency, as determined
by the Secretary, shall submit to the appropriate
committees of Congress the national bioforensics
strategy.
(e) Authorization of Appropriations.--There are authorized
to be appropriated such sums as may be necessary to carry out
this section.
* * * * * * *
TITLE V--EMERGENCY PREPAREDNESS AND RESPONSE
* * * * * * *
SEC. 504. [6 U.S.C. Sec. 314] AUTHORITY AND RESPONSIBILITIES
(a) In General.--The Administrator shall provide Federal
leadership necessary to prepare for, protect against, respond
to, recover from, or mitigate against a natural disaster, act
of terrorism, or other man-made disaster, including--
(1) * * *
* * * * * * *
(20) enhancing and promoting the preparedness of
individuals and communities for natural disasters, acts
of terrorism, and other man-made disasters;
[(20)] (21) carrying out all authorities of the
Federal Emergency Management Agency and the Directorate
of Preparedness of the Department as transferred under
section 315 of this title; and
[(21)] (22) otherwise carrying out the mission of the
Agency as described in section 313(b) of this title.
* * * * * * *
SEC. 525. COMMUNICATIONS PLANNING.
(a) Incorporation of Communications Plans.--
(1) In general.--The Secretary, acting through the
Administrator of the Federal Emergency Management
Agency, shall incorporate into each operational plan
developed under sections 653(a)(4) and 653(b) of the
Post-Katrina Emergency Management Reform Act of 2006 (6
U.S.C. Sec. 701 note) a communications plan for
providing information to the public related to
preventing, preparing for, protecting against, and
responding to imminent natural disasters, acts of
terrorism, and other man-made disasters, including
incidents involving the use of weapons of mass
destruction and other potentially catastrophic events.
(2) Consultation.--In developing communications plans
under paragraph (1), the Administrator shall consult
with State, local, and tribal governments and
coordinate, as the Administrator considers appropriate,
with other Federal departments and agencies that have
responsibilities under the National Response Framework
and other relevant Federal departments and agencies.
(b) Prescripted Messages and Message Templates.--
(1) In general.--As part of the communication plans,
the Administrator shall develop prescripted messages or
message templates, as appropriate, to be included in
the plans to be provided to State, local, and tribal
officials so that those officials can quickly and
rapidly disseminate critical information to the public
in anticipation or in the immediate aftermath of a
disaster or incident.
(2) Development and design.--The prescripted messages
or message templates shall--
(A) be developed, as the Administrator
determines appropriate, in consultation with
State, local, and tribal governments and in
coordination with other Federal departments and
agencies that have responsibilities under the
National Response Framework and other relevant
Federal departments and agencies;
(B) be designed to provide accurate,
essential, and appropriate information and
instructions to the population directly
affected by a disaster or incident, including
information related to evacuation, sheltering
in place, and issues of immediate health and
safety; and
(C) be designed to provide accurate,
essential, and appropriate technical
information and instructions to emergency
response providers and medical personnel
responding to a disaster or incident.
(c) Communications Formats.--In developing the prescripted
messages or message templates required under subsection (b),
the Administrator shall develop each such prescripted message
or message template in multiple formats to ensure delivery--
(1) in cases where the usual communications
infrastructure is unusable as a result of the nature of
a disaster or incident; and
(2) to individuals with disabilities or other special
needs and individuals with limited English proficiency
in accordance with section 616 of the Post-Katrina
Emergency Management Reform Act of 2006 (6 U.S.C.
Sec. 701 note).
(d) Dissemination and Technical Assistance.--The
Administrator shall ensure that all prescripted messages and
message templates developed under this section are made
available to State, local, and tribal governments so that those
governments may incorporate them, as appropriate, into their
emergency plans. The Administrator shall also make available
relevant technical assistance to those governments to support
communications planning.
(e) Exercises.--To ensure that the prescripted messages or
message templates developed under this section can be
effectively utilized in a disaster or incident, the
Administrator shall incorporate such prescripted messages or
message templates into exercises conducted under the National
Exercise Program described in section 648 of the Post-Katrina
Emergency Management Reform Act of 2006 (6 U.S.C. Sec. 701
note).
(f) Report.--Not later than 1 year after the date of the
enactment of this section, the Administrator shall submit to
the Committee on Homeland Security and Governmental Affairs of
the Senate and the Committee on Homeland Security of the House
of Representatives a copy of the communications plans required
to be developed under this section, including prescripted
messages or message templates developed in conjunction with the
plans and a description of the means that will be used to
deliver such messages in a natural disaster, act of terrorism,
or other manmade disaster.
SEC. 526. INDIVIDUAL AND COMMUNITY PREPAREDNESS.
(a) In General.--The Administrator shall assist State,
local, and tribal governments in improving and promoting
individual and community preparedness for natural disasters,
acts of terrorism, and other man-made disasters, including
incidents involving the use of weapons of mass destruction and
other potentially catastrophic events, by--
(1) developing guidelines and checklists of
recommended actions for individual and community
prevention and preparedness efforts and disseminating
such guidelines and checklists to communities and
individuals;
(2) disseminating the guidelines developed under
section 502 of the Weapons of Mass Destruction
Prevention and Preparedness Act of 2009 to communities
and individuals, as appropriate;
(3) compiling and disseminating information on best
practices in individual and community preparedness;
(4) providing information and training materials in
support of individual and community preparedness
efforts;
(5) conducting individual and community preparedness
outreach efforts; and
(6) such other actions as the Administrator
determines appropriate.
(b) Coordination.--Where appropriate, the Administrator
shall coordinate with private sector and nongovernmental
organizations to promote individual and community preparedness.
(c) Support for Voluntary Programs.--In carrying out the
responsibilities described in subsection (a), the Administrator
shall, where appropriate, work with and provide support to
individual and community preparedness programs, such as the
Community Emergency Response Team Program, Fire Corps, Medical
Reserve Corps Program, Volunteers in Police Service,
USAonWatch-Neighborhood Watch, and other voluntary programs,
including those sponsored by nongovernmental organizations.
(d) Director.--The Administrator shall appoint a Director
of Community Preparedness to coordinate and oversee the
individual and community preparedness efforts of the Agency.
(e) Grants.--
(1) In general.--The Administrator may make grants to
States to support individual and community preparedness
efforts, including through the Citizen Corps Program.
(2) Appropriations.--There are authorized to be
appropriated for grants under this section--
(A) $15,000,000 for fiscal year 2011;
(B) $20,000,000 for fiscal year 2012; and
(C) $20,000,000 for fiscal year 2013.
AGRICULTURAL BIOTERRORISM PROTECTION ACT OF 2002
* * * * * * *
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
* * * * * * *
Subtitle B--Department of Agriculture
* * * * * * *
SEC. 212. [7 U.S.C. Sec. 8401] REGULATION OF CERTAIN BIOLOGICAL AGENTS
AND TOXINS.
(a) Regulatory Control of Certain Biological Agents and
Toxins.--
(1) List of biological agents and toxins.--
(A) In general.--The Secretary of Agriculture
shall by regulation establish and maintain a
list of each biological agent and each toxin
that the Secretary determines has the potential
to pose a severe threat to animal or plant
health, or to animal or plant products.
(B) Criteria.--In determining whether to
include an agent or toxin on the list under
subparagraph (A), the Secretary shall--
(i) Consider--
(I) the effect of exposure to
the agent or toxin on animal or
plant health, and on the
production and marketability of
animal or plant products;
(II) the pathogenicity of the
agent or the toxicity of the
toxin and the methods by which
the agent or toxin is
transferred to animals or
plants;
(III) the suitability of the
agent or toxin to be used in a
biological attack;
[(III)] (IV) the availability
and effectiveness of
pharmacotherapies and
prophylaxis to treat and
prevent any illness caused by
the agent or toxin; and
[(IV)] (V) any other criteria
that the Secretary considers
appropriate to protect animal
or plant health, or animal or
plant products; and
(ii) consult with appropriate Federal
departments and agencies and with
scientific experts representing
appropriate professional groups.
(2) Tier i agents.--
(A) Designation of tier agents.--Not later
than 180 days after the date of enactment of
the Weapons of Mass Destruction Prevention and
Preparedness Act of 2009, the Secretary, in
coordination with the Secretary of Homeland
Security, shall by regulation designate as
`Tier I agents' those agents and toxins--
(i) for which the Secretary of
Homeland Security has issued a Material
Threat Determination under section
319F-2(c)(2) of the Public Health
Service Act (42 U.S.C. Sec. 247d-
6b(c)(2)) regarding the agent or toxin,
unless the Secretary of Agriculture
determines, in coordination with the
Secretary of Homeland Security, that
such designation is unwarranted; or
(ii) that meet the criteria under
subparagraph (B).
(B) Criteria.--In determining whether to
designate an agent or toxin as a Tier I agent
under subparagraph (A), the Secretary, in
coordination with the Secretary of Homeland
Security, shall consider--
(i) whether the agent or toxin has
clear potential to be used effectively
in a biological attack that causes
catastrophic consequences;
(ii) information available from any
biological or bioterrorism risk
assessments conducted by the Department
of Homeland Security or relevant
assessments by other agencies; and
(iii) such other criteria and
information that the Secretary
determines appropriate and relevant.
(C) Inclusion of agents and toxins not
previously listed.--All agents or toxins
designated by the Secretary as Tier I agents
shall be included on the list maintained by the
Secretary pursuant to paragraph (1).
(D) Evaluation of tier i agents.--The
Secretary, in coordination with the Secretary
of Homeland Security, shall--
(i) on an ongoing basis, consider the
inclusion of additional agents or
toxins on the list of Tier I agents, as
appropriate; and
(ii) at least biennially, review the
list of Tier I agents to determine
whether any agents or toxins should be
removed from the list.
[(2)] (3) Biennial review.--The Secretary shall
review and republish the [list under paragraph (1)]
lists under paragraphs (1) and (2) biennially, or more
often as needed, and shall by regulation revise the
[list as necessary in accordance with such paragraph]
lists as necessary in accordance with such paragraphs.
(b) * * *
(c) * * *
(d) Registration; Identification; Database.--
(1) * * *
(2) * * *
(3) Federal agency access.--The Secretary shall
ensure access to the database established pursuant to
paragraph (2) by the Secretary of Health and Human
Services, the Secretary of Homeland Security, the
Attorney General, the Secretary of Energy, the
Secretary of Defense, and any other Federal agency that
the Secretary determines appropriate.
(e) * * *
(f) * * *
(g) Exemptions.--
(1) Overlap agents and toxins.--
(A) * * *
* * * * * * *
(E) Public health emergencies.--Upon request
of the Secretary of Health and Human Services,
after the granting by such Secretary of an
exemption under [351A(g)(3)] 351A(h)(3) of
title 42 pursuant to a finding that there is a
public health emergency, the Secretary of
Agriculture may temporarily exempt a person
from the applicability of the requirements of
this section with respect to an overlap agent
or toxin, in whole or in part, to provide for
the timely participation of the person in a
response to the public health emergency. With
respect to the emergency involved, such
exemption for a person may not exceed 30 days,
except that upon request of the Secretary of
Health and Human Services, the Secretary of
Agriculture may, after review of whether such
exemption remains necessary, provide one
extension of an additional 30 days.
MINORITY VIEWS OF SENATOR CARL LEVIN
I commend the Homeland Security and Governmental Affairs
Committee for its focus on security threats that could pose a
risk to our Nation and our way of life, including threats from
weapons of mass destruction (WMD). The evolving threat of
bioterrorism requires a carefully coordinated and integrated
whole-of-government approach, both to stay ahead of the threat
and to ensure that our own crucial biological research and
development capabilities are not impaired.
It is with those priorities in mind that I oppose some of
the provisions contained in S. 1649, the ``Weapons of Mass
Destruction Prevention and Preparedness Act of 2009.'' After
taking into account the views of the Administration and outside
experts, and considering the full range of significant
Administration actions on biosecurity--both before and after
the bill was reported by the committee--I cannot support this
legislation in its current form.
S. 1649 would duplicate efforts in many areas that are in
critical need of unification, it would complicate important
biosecurity and biosafety regulations without providing clear
security gains, and it still is not supported by crucial
stakeholders in and out of government. The main thrust of the
bill would run contrary to key recommendations of the very
commission that triggered this legislation. These serious
shortcomings have not been addressed in this legislation, and
that is why I voted against the bill while it was before this
committee. Preventing and mitigating a biological attack is
sufficiently important and complex that we must take the time
to get it right as we seek to improve our bio-security and
safety.
If this legislation moves forward, I look forward to
working with this committee as well as other colleagues in the
Senate to improve this legislation, to consider suggested
Administration, outside expert, and other Senate Committees'
changes. I am confident that such additional work could produce
a bill that is much more effective, is more consistent with
current law, policy, and stakeholder views, and helps
strengthen regulation without hindering critical research and
development to protect our Nation.
According to Senators Lieberman and Collins, S. 1649 was
motivated by the December 2008 report of the Commission on the
Prevention of WMD Proliferation and Terrorism (WMD Commission),
World at Risk, and was intended to implement its major
recommendations. One of the key recommendations that the WMD
Commission made, repeatedly and explicitly, was that the
Department of Health and Human Services (HHS) should have the
lead federal responsibility for regulating and overseeing
dangerous biological agents. Unfortunately, S. 1649 runs
contrary to that key recommendation, and would give that
responsibility to the Department of Homeland Security (DHS).
This is a major shortcoming of the proposed legislation.
Senators Lieberman and Collins have stated that there will
be opportunities to continue to work with the Administration,
other committees, and Senators as the bill moves toward Senate
consideration. I welcome that commitment, since I believe the
Senate should consider changes to the legislation based on
current circumstances and consider changes based on
recommendations of the Administration and the outside
scientific community.
For example, since S. 1649 was reported out of committee on
November 4, 2009, the Administration has taken a number of
significant actions on biosecurity, as had been expected. These
actions--such as the July 2, 2010 Executive Order 13456 on
``Optimizing the Security of Biological Select Agents and
Toxins in the United States,'' and the December 30, 2009
Executive Order 13527 on ``Establishing Federal Capability for
the Timely Provision of Medical Countermeasures Following a
Biological Attack''--would obviate much of the legislation
contained within S. 1649.
Also, since the markup of S. 1649, the Administration has
completed a number of important interagency reviews of
biosecurity and biosafety issues and has produced many
recommendations and policy decisions to improve the security of
the Nation against biological threats. In addition, a number of
important reports and studies have been published recently with
carefully considered recommendations for improving our security
against potential biological threats. I believe it is critical
for Congress to consider fully these actions and
recommendations before acting on legislation concerning
biosecurity and biosafety.
I would encourage my colleagues to review carefully the
current state of efforts to counter bioterrorism before
considering legislation on this issue. This is a technically
complex issue with potential pitfalls as well as opportunities
for improvement. I believe we should fully consider the results
of the Administration's substantial recent efforts and its
official views, as well as the various reports that have been
published in the last 18 months, and the views of outside
scientific groups, before legislating in this area. Such
consideration would ensure that any changes we make would
enhance our security while not causing unintended consequences.
It is my hope that considering these substantial recent
actions and recommendations would provide a useful path forward
to continue to improve our Nation's safety and security without
sacrificing the critical scientific expertise and research
capabilities that are integral to our safety and security. I
commend my colleagues on their efforts, and I look forward to
working with them and other members of the Senate on these very
important issues in the future.
Carl Levin.