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

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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \26\National Strategy for Countering Biological Threats at 2.
---------------------------------------------------------------------------

       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.
---------------------------------------------------------------------------
    \27\World at Risk at 23. Emphasis on the role for policy makers 
added.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \32\High-Containment Laboratories: National Strategy for Oversight 
is Needed. GAO-09-574, September 2009.
---------------------------------------------------------------------------
    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.''
---------------------------------------------------------------------------
    \33\National Strategy for Countering Biological Threats at 13.
---------------------------------------------------------------------------

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

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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \53\Department of Homeland Security Appropriations Act, 2007, P.L. 
109-295, section 550, (2006).
---------------------------------------------------------------------------
    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).
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------

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

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

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

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