[House Report 112-665]
[From the U.S. Government Publishing Office]
112th Congress Rept. 112-665
HOUSE OF REPRESENTATIVES
2d Session Part 1
======================================================================
WMD PREVENTION AND PREPAREDNESS ACT OF 2012
_______
September 12, 2012.--Ordered to be printed
_______
Mr. King of New York, from the Committee on Homeland Security,
submitted the following
R E P O R T
together with
ADDITIONAL VIEWS
[To accompany H.R. 2356]
[Including cost estimate of the Congressional Budget Office]
The Committee on Homeland Security, to whom was referred
the bill (H.R. 2356) to enhance homeland security by improving
efforts to prevent, protect against, respond to, and recover
from an attack with a weapon of mass destruction, and for other
purposes, having considered the same, report favorably thereon
with an amendment and recommend that the bill as amended do
pass.
CONTENTS
Page
Purpose and Summary.............................................. 27
Background and Need for Legislation.............................. 27
Hearings......................................................... 28
Committee Consideration.......................................... 32
Committee Votes.................................................. 33
Committee Oversight Findings..................................... 34
New Budget Authority, Entitlement Authority, and Tax Expenditures 34
Congressional Budget Office Estimate............................. 34
Statement of General Performance Goals and Objectives............ 36
Congressional Earmarks, Limited Tax Benefits, and Limited Tariff
Benefits....................................................... 38
Federal Mandates Statement....................................... 38
Preemption Clarification......................................... 38
Advisory Committee Statement..................................... 38
Applicability to Legislative Branch.............................. 38
Section-by-Section Analysis of the Legislation................... 38
Changes in Existing Law Made by the Bill, as Reported............ 61
Additional Views................................................. 87
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``WMD Prevention and
Preparedness Act of 2012''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
TITLE I--A NATIONAL BIODEFENSE ENTERPRISE
Sec. 101. Special Assistant for Biodefense.
Sec. 102. National Biodefense Plan.
Sec. 103. National Biosurveillance Strategy.
Sec. 104. Comprehensive cross-cutting biodefense budget analysis.
TITLE II--INTELLIGENCE MATTERS
Sec. 201. National Intelligence Strategy for Countering the Threat from
Weapons of Mass Destruction.
Sec. 202. National Intelligence Strategy for Countering Biological
Threats.
Sec. 203. State, local, and tribal defined.
TITLE III--HOMELAND SECURITY MATTERS
Sec. 301. Weapons of mass destruction prevention and preparedness.
``TITLE XXI--WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS
``Subtitle A--Prevention
``Sec. 2101. Weapons of mass destruction intelligence and
information sharing.
``Sec. 2102. Risk assessments.
``Sec. 2103. National Export Enforcement Coordination.
``Sec. 2104. Communication of threat information.
``Sec. 2105. Individual and community preparedness for
chemical, biological, radiological, and nuclear
attacks.
``Subtitle B--Protection
``Sec. 2121. Detection of biological attacks.
``Sec. 2122. Rapid biological threat detection and
identification at ports of entry.
``Sec. 2123. Evaluating detection technology.
``Sec. 2124. Domestic implementation of the Global Nuclear
Detection Architecture.
``Subtitle C--Response
``Sec. 2131. First responder guidance concerning chemical,
biological, radiological, and nuclear attacks.
``Sec. 2132. Integrated plume modeling for collective response.
``Sec. 2133. Establishment of the system assessment and
validation for emergency responders (SAVER)
program.
``Sec. 2134. Payment for laboratory response services.
``Sec. 2135. Bioforensics capabilities.
``Sec. 2136. Metropolitan Medical Response System Program.
``Subtitle D--Recovery
``Sec. 2141. Identifying and addressing gaps in recovery
capabilities.
``Sec. 2142. Recovery from a chemical, biological,
radiological, and nuclear attack or incident.
``Sec. 2143. Exercises.
Sec. 302. Enhancing laboratory biosecurity.
Sec. 303. Definitions.
Sec. 304. Dual-use terrorist risks from synthetic biology.
Sec. 305. Dissemination of information analyzed by the Department to
State, local, tribal, and private entities with responsibilities
relating to homeland security.
TITLE IV--PUBLIC HEALTH MATTERS
Sec. 401. Sense of Congress regarding Federal coordination on medical
countermeasures.
Sec. 402. National Medical Countermeasure Dispensing Strategy.
``Sec. 319F-5. National Medical Countermeasure Dispensing
Strategy.
Sec. 403. National pre-event vaccination and antimicrobial dispensing
policy review.
Sec. 404. Management of short shelf life vaccine and antimicrobial
stockpiles.
Sec. 405. Material threat determinations reviews.
Sec. 406. Background checks.
Sec. 407. State, local, and tribal defined.
TITLE V--FOREIGN RELATIONS MATTERS
Sec. 501. International engagement to enhance biodefense and laboratory
biosecurity.
Sec. 502. International collaboration and information sharing relating
to biosecurity.
Sec. 503. Interagency task force on best practices for global
biopreparedness.
Sec. 504. Biological and Toxin Weapons Convention.
SEC. 2. DEFINITIONS.
In this Act:
(1) The term ``appropriate congressional committees'' means
the Committee on Homeland Security of the House of
Representatives and any committee of the House of
Representatives or the Senate having legislative jurisdiction
under the rules of the House of Representatives or Senate,
respectively, over the matter concerned.
(2) The term ``Intelligence Community'' has the meaning given
that term in section 3(4) of the National Security Act of 1947
(50 U.S.C. 401a(4)).
(3) The term ``national biosecurity and biodefense
stakeholders'' means officials from the Federal, State, local,
and tribal authorities and individuals and other persons from
the private sector who are involved in efforts to prevent,
protect against, respond to, and recover from a biological
attack or other phenomena that may have serious health
consequences for the United States, including wide-scale
fatalities or infectious disease outbreaks.
TITLE I--A NATIONAL BIODEFENSE ENTERPRISE
SEC. 101. SPECIAL ASSISTANT FOR BIODEFENSE.
(a) In General.--The President shall assign a member of the National
Security Council to serve as Special Assistant to the President for
Biodefense, who shall--
(1) serve as the principal advisor to the President regarding
coordination of Federal biodefense policy including prevention,
protection, response, and recovery from biological attacks or
other phenomena that may have serious health consequences for
the United States, including wide-scale fatalities or
infectious disease outbreaks;
(2) identify gaps, duplication, and other inefficiencies in
existing biodefense activities and the actions necessary to
overcome these obstacles;
(3) lead the development of a coordinated National Biodefense
Plan, in accordance with section 102;
(4) lead the development of a coordinated National
Biosurveillance Strategy, in accordance with section 103;
(5) lead the development of a coordinated national research
and development strategy and implementation plan for microbial
forensics, the latter to be updated not less than once every 4
years;
(6) oversee, in coordination with the Director of the Office
of Management and Budget, the development of a comprehensive
cross-cutting biodefense budget analysis to inform
prioritization of resources and ensure that biodefense
challenges are adequately addressed, in accordance with section
104; and
(7) conduct ongoing oversight and evaluation of
implementation of Federal biodefense activities by relevant
Government departments and agencies.
(b) Access by Congress.--The appointment of the Special Assistant to
the President for Biodefense shall not be construed as affecting access
by Congress or committees of either House of Congress to information,
documents, and studies in the possession of, or conducted by or at the
direction of, the Special Assistant.
SEC. 102. NATIONAL BIODEFENSE PLAN.
The Special Assistant to the President for Biodefense shall submit to
the President a National Biodefense Plan that--
(1) defines the scope and purpose of a national biodefense
capability;
(2) identifies biological risks to the Nation to be addressed
by the Plan, consistent with section 2102 of the Homeland
Security Act of 2002, as amended by this Act;
(3) delineates activities and tasks to be performed,
including prevention, protection, response, and recovery
activities, to address the risks identified under paragraph
(2);
(4) defines research and development needs for improving the
capacity for threat awareness and prevention, protection,
response, and recovery;
(5) identifies biodefense assets, interdependencies,
capability gaps, and gaps in the integration of capabilities;
(6) provides goals, activities, milestones, and performance
measures;
(7) identifies resource and investment needs;
(8) defines organizational roles, responsibilities , and
coordination of Federal, State, local, and tribal authorities
(as those terms are defined in the Homeland Security Act of
2002 (6 U.S.C. 101 et seq.)) with respect to the activities and
tasks delineated in paragraph (3);
(9) integrates and supports the strategies outlined in
Presidential Policy Directives 2 and 8 and Homeland Security
Presidential Directives 5, 9, 10, 18, 21, and their successors,
the National Biosurveillance Strategy published under section
103 of this Act, the National Medical Countermeasure Dispensing
Strategy developed under section 319F-5 of the Public Health
Service Act, as amended by this Act, and other strategy
documents as appropriate;
(10) is consistent with the National Response Framework as
published by the Secretary of Homeland Security in January
2008, and any successors thereof;
(11) incorporates input from Federal, State, local, and
tribal stakeholders;
(12) provides planning guidance to biosecurity and biodefense
stakeholders, including leveraging of existing guidance; and
(13) shall be submitted to the President and the Congress
within 18 months after the date of the enactment of this Act,
and updated as necessary.
SEC. 103. NATIONAL BIOSURVEILLANCE STRATEGY.
(a) Strategy for Biosurveillance.--The Special Assistant to the
President for Biodefense shall publish a National Biosurveillance
Strategy that shall--
(1) identify the purpose and scope of a nationally integrated
biosurveillance capability;
(2) establish goals, objectives, priorities, milestones, and
performance measures to guide the development of such
capability;
(3) define and prioritize costs, benefits, and resource and
investment needs, with particular attention to leveraging
existing resources;
(4) delineate Federal, State, local, tribal, and private
roles and responsibilities; and
(5) describe how the Strategy is integrated with related
national strategies.
(b) Matters for Consideration.--In developing the strategy required
under subsection (a), the Special Assistant shall take into
consideration--
(1) the state of biosurveillance domestically and
internationally;
(2) material threat assessments and determinations developed
by the Secretary of Homeland Security in accordance with the
Project BioShield Act of 2004 (Public Law 108-276) and the
amendments made by that Act;
(3) risk assessments consistent with section 2102 of the
Homeland Security Act of 2002, as amended by this Act;
(4) reports on global trends produced by the Office of the
Director of National Intelligence regarding the biological
threat;
(5) Intelligence Community needs as articulated in relevant
intelligence strategies;
(6) information available in biosurveillance systems and
changes to information technology including systems used
commercially to allow for the incorporation and integration of
this information; and
(7) costs associated with establishing and maintaining the
necessary infrastructure to integrate biosurveillance systems.
(c) Implementation Plan.--In addition to the strategy required under
subsection (a), the Special Assistant shall publish an implementation
plan for such strategy that includes benchmarks for measuring the
success of the Strategy. The implementation plan shall--
(1) include a plan for advancing situational awareness of
biological threats, by rapid detection and dissemination of
biosurveillance information in real time, and through other
means;
(2) include a plan for fostering information sharing among
national biosecurity and biodefense stakeholders--
(A) to identify potential threats, reduce
vulnerabilities, and improve collective response
activities to, and investigations of, suspected
biological attacks;
(B) that addresses the type of information to be
shared and how it will be shared; and
(C) that identifies critical sensitivities to be
protected; and
(3) include a plan for enhancing the capability of the
Federal Government to rapidly identify, characterize, localize,
and track a biological event of national concern by integrating
and analyzing data relating to human health, animal, plant,
food, and environmental monitoring systems (both national and
international).
(d) Deadline; Submission; Updates.--The Special Assistant shall--
(1) publish the strategy, and submit it to the appropriate
congressional committees, by not later than 1 year after the
date of enactment of this Act; and
(2) publish an implementation plan for such strategy not
later than 2 years after the date of enactment of this Act, and
update the implementation plan at least once every 4 years.
SEC. 104. COMPREHENSIVE CROSS-CUTTING BIODEFENSE BUDGET ANALYSIS.
(a) In General.--In order to enhance strategic planning, eliminate
redundancies, identify capability gaps, and provide for greater
transparency, the Special Assistant to the President for Biodefense, in
coordination with the Director of the Office of Management and Budget,
shall transmit to the appropriate congressional committees, concurrent
with the submission of the President's annual budget to the Congress, a
comprehensive cross-cutting biodefense budget analysis that delineates
and integrates the biodefense expenditure requests for the departments
and agencies headed by the officials listed in subsection (c).
(b) Contents.--
(1) In general.--The comprehensive cross-cutting biodefense
budget analysis shall provide a detailed, separate analysis, by
budget function, by department or agency, and by initiative
area (as determined by the Administration), for the prior
fiscal year, the current fiscal year, and the fiscal years for
which the budget is submitted, identifying the amounts of gross
and net appropriations or obligational authority and outlays
that contribute to biodefense, with separate displays for
mandatory and discretionary amounts, including--
(A) summaries of the total amount of such
appropriations or obligational authority and outlays
requested for biodefense;
(B) an estimate of the current service levels of
biodefense spending; and
(C) an indication of how the Federal activities or
accounts covered by the analysis support the activities
delineated in the National Biodefense Plan under
section 102(2).
(2) Account-level amounts.--With respect to subparagraphs (A)
through (C) of paragraph (1), amounts shall be provided by
account for each program, project, and activity.
(c) Coordination.--
(1) Submission to special assistant.--Each official listed in
paragraph (2) shall, by not later than 30 days before
submitting the annual appropriations request for the agency
under section 1108 of title 31, United States Code, submit to
the Special Assistant--
(A) the proposed appropriations request; and
(B) a progress report on how the department or agency
under the official's authority agency has met the
responsibilities of the official under the National
Biodefense Plan under section 102.
(2) Covered official.--The officials referred to in paragraph
(1) are--
(A) the Secretary of Agriculture;
(B) the Secretary of Commerce;
(C) the Secretary of Defense;
(D) the Secretary of Energy;
(E) the Secretary of Health and Human Services;
(F) the Secretary of Homeland Security;
(G) the Secretary of State;
(H) the Secretary of Veterans Affairs;
(I) the Attorney General;
(J) the Administrator of the Environmental Protection
Agency;
(K) the Director of the National Science Foundation;
(L) the Postmaster General of the United States; and
(M) heads of other Federal departments and agencies
as considered appropriate by the Special Assistant.
(d) Consultation With Congress.--Periodically, but at least annually,
the Special Assistant for Biodefense shall consult with the Committee
on Homeland Security of the House of Representatives, the Committee on
Homeland Security and Governmental Affairs of the Senate, the Budget
Committees of the House of Representatives and the Senate, the
Appropriations Committees of the House of Representatives and the
Senate, and the Congressional Budget Office.
TITLE II--INTELLIGENCE MATTERS
SEC. 201. NATIONAL INTELLIGENCE STRATEGY FOR COUNTERING THE THREAT FROM
WEAPONS OF MASS DESTRUCTION.
(a) Strategy.--
(1) Development.--The Director of National Intelligence, in
consultation with the Secretary of Homeland Security and the
heads of other appropriate Federal departments and agencies,
shall develop and implement--
(A) a strategy designed to improve the capabilities
of the United States to collect, analyze, and
disseminate intelligence related to weapons of mass
destruction; and
(B) a plan to implement such strategy.
(2) Title.--The strategy required under paragraph (1) shall
be known as the ``National Intelligence Strategy for Countering
the Threat from Weapons of Mass Destruction''.
(b) Contents.--The strategy required under subsection (a) shall--
(1) identify and address core capabilities needed for
successful intelligence collection on weapons of mass
destruction;
(2) include methods for the recruitment, training, and
retention of a workforce with expertise in the collection,
analysis, and dissemination of intelligence related to all
types of weapons of mass destruction and science and technology
related to weapons of mass destruction, as well as expertise in
science and technology relating to risks posed by weapons of
mass destruction; and
(3) include methods for information sharing and
collaboration, as appropriate, with non-Federal national
biosecurity and biodefense stakeholders.
(c) Implementation Plan.--The plan for implementing the strategy
required under subsection (a) shall include--
(1) actions necessary to increase the effectiveness and
efficiency of the sharing of intelligence on weapons of mass
destruction throughout the Intelligence Community and with
other Federal partners, including a description of statutory,
regulatory, policy, technical, security, or other barriers that
impede such sharing, and, as appropriate, the development of
uniform standards across the Intelligence Community for such
sharing;
(2) methods to disseminate intelligence products to national
biosecurity and biodefense stakeholders in classified and
unclassified formats to increase the effectiveness and
efficiency of the sharing of information;
(3) actions necessary to provide open-source intelligence
relating to weapons of mass destruction to--
(A) appropriate Federal departments and agencies;
(B) State, local, and tribal authorities; and
(C) private entities;
(4) specific objectives to be accomplished, with
corresponding schedule, for each year of the 5-year period that
begins on the date on which the strategy is submitted to the
appropriate congressional committees under subsection (e) and
tasks to accomplish such objectives, including--
(A) a list prioritizing such objectives and such
tasks; and
(B) a schedule for meeting such objectives and
carrying out such tasks;
(5) assignments of roles and responsibilities to elements of
the Intelligence Community to implement the strategy; and
(6) a schedule for assessment of the effectiveness and
efficiency of the strategy, including metrics, and a
description of the components of the assessment.
(d) Coordination.--The Director of National Intelligence shall
coordinate with State, local, and tribal government authorities, the
private sector, and nongovernmental organizations in the development of
the National Intelligence Strategy for Countering the Threat from
Weapons of Mass Destruction.
(e) Deadline for Submission.--Not later than 6 months after the date
of the enactment of this Act, the Director of National Intelligence
shall submit to the appropriate congressional committees the strategy
and plan required under subsection (a). The submission shall be in
unclassified form but with a classified annex, as appropriate.
(f) Updates.--The Director of National Intelligence shall update the
implementation plan at least once every 4 years.
SEC. 202. NATIONAL INTELLIGENCE STRATEGY FOR COUNTERING BIOLOGICAL
THREATS.
(a) Strategy.--
(1) Development.--The Director of National Intelligence, in
consultation with the Secretary of Homeland Security, the
Secretary of Health and Human Services, the Secretary of
Agriculture, the Special Assistant to the President for
Biodefense, and the heads of other appropriate Federal
departments and agencies, shall develop and implement a
strategy and a plan for implementing the strategy that is
integrated into the National Intelligence Strategy for
Countering the Threat from Weapons of Mass Destruction, as
required under this title.
(2) Title.--The strategy required under paragraph (1) shall
be known as the ``National Intelligence Strategy for Countering
Biological Threats''.
(b) Contents.--The strategy required under subsection (a) shall--
(1) identify and address target capabilities needed for
successful intelligence collection on biological threats;
(2) include a plan for establishing in the Intelligence
Community a cadre of collectors and analysts in all relevant
agencies in the Intelligence Community that are familiar with
biological threats, biological science, and biotechnology,
including--
(A) biological scientists;
(B) biotechnologists; and
(C) experts with knowledge of the current state of
technologies that could be used to develop a weapon of
mass destruction;
(3) include a plan for defining the functions, capabilities,
and gaps in the Intelligence Community workforce with respect
to assessing the biological threat;
(4) include methods for collaboration--
(A) with non-Intelligence Community technical experts
within Federal departments and agencies; and
(B) as appropriate, with individuals with expertise
described in paragraph (2) who are not employed by the
Federal Government, in particular with State and local
biodefense stakeholders;
(5) include a plan for defining, integrating, focusing, and
enhancing existing capabilities in the Intelligence Community
dedicated to current and strategic biological threats; and
(6) include a plan for ensuring the prioritization and
sustained commitment of intelligence personnel and resources to
address biological threats.
(c) Implementation Plan.--The implementation plan for the strategy
required under subsection (a) shall--
(1) include actions necessary to increase the effectiveness
and efficiency of the sharing of intelligence throughout the
Intelligence Community on biological weapons and organisms that
could be used for biological terrorism, including a description
of statutory, regulatory, policy, technical, security, or other
barriers that prevent such sharing, and, as appropriate, the
development of uniform standards across the Intelligence
Community for such sharing;
(2) address strategic and tactical human intelligence,
measurement and signature intelligence, technical intelligence,
medical intelligence, and open-source intelligence activities
necessary to implement the strategy;
(3) identify specific objectives to be accomplished during
each year of the 5-year period that begins on the date on which
the strategy is submitted to the appropriate congressional
committees under subsection (d) and tasks to accomplish such
objectives, including--
(A) a list prioritizing such objectives and such
tasks; and
(B) a schedule for meeting such objectives and
carrying out such tasks;
(4) assign roles and responsibilities to elements of the
Intelligence Community to implement the strategy;
(5) a schedule for assessment of the effectiveness and
efficiency of the strategy, including metrics; and
(6) a schedule for evaluating on a regular basis the efforts
of the Intelligence Community and progress on understanding and
countering biological threats.
(d) Report.--Not later than 1 year after the date of the enactment of
this Act, the Director of National Intelligence shall submit to the
appropriate congressional committees the strategy and plan required
under subsection (a). The report shall be in unclassified form but with
a classified annex, as appropriate.
(e) Updates.--The Director of National Intelligence shall update the
implementation plan at least once every 4 years.
SEC. 203. STATE, LOCAL, AND TRIBAL DEFINED.
In this title, the term ``State, local, and tribal'' has the same
meaning that term has in the Homeland Security Act of 2002 (6 U.S.C.
101 et seq.).
TITLE III--HOMELAND SECURITY MATTERS
SEC. 301. WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS.
(a) In General.--The Homeland Security Act of 2002 (6 U.S.C. 101 et
seq.) is amended by adding at the end the following new title:
``TITLE XXI--WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS
``Subtitle A--Prevention
``SEC. 2101. WEAPONS OF MASS DESTRUCTION INTELLIGENCE AND INFORMATION
SHARING.
``(a) In General.--The Office of Intelligence and Analysis of the
Department shall--
``(1) conduct intelligence and information sharing activities
consistent with the National Intelligence Strategy for
Countering the Threat from Weapons of Mass Destruction under
section 201 of the WMD Prevention and Preparedness Act of 2012
and the National Intelligence Strategy for Countering
Biological Threats under section 202 of that Act;
``(2) support homeland security-focused intelligence analysis
of terrorist actors, their claims, and their plans to conduct
attacks involving chemical, biological, radiological, and
nuclear materials against the Nation;
``(3) support homeland security-focused intelligence analysis
of global infectious disease, public health, food,
agricultural, and veterinary issues;
``(4) support homeland security-focused risk analysis and
risk assessments of the homeland security hazards described in
paragraphs (2) and (3), by providing relevant quantitative and
nonquantitative threat information;
``(5) leverage existing and emerging homeland security
capabilities and structures, including fusion centers
established pursuant to section 210A, to enhance prevention,
protection, response, and recovery efforts with respect to a
chemical, biological, radiological, or nuclear attack;
``(6) share information and provide tailored analytical
support on these threats to State, local, and tribal
authorities as well as other national biosecurity and
biodefense stakeholders; and
``(7) perform other responsibilities, as assigned by the
Secretary.
``(b) Coordination.--Where appropriate, the Office of Intelligence
and Analysis shall coordinate with other relevant Department
components, others in the Intelligence Community, including the
National Counter Proliferation Center, and other Federal, State, local,
and tribal authorities, including officials from high-threat areas, and
enable such entities to provide recommendations on optimal information
sharing mechanisms, including expeditious sharing of classified
information, and on how they can provide information to the Department.
``(c) Report.--
``(1) In general.--Not later than 1 year after the date of
the enactment of this section and annually thereafter, the
Secretary shall report to the appropriate congressional
committees on--
``(A) the intelligence and information sharing
activities under subsection (a) and of all relevant
entities within the Department to counter the threat
from weapons of mass destruction; and
``(B) the Department's activities in accordance with
relevant intelligence strategies, including the
National Intelligence Strategy for Countering the
Threat from Weapons of Mass Destruction and the
National Intelligence Strategy for Countering
Biological Threats.
``(2) Assessment of implementation.--The report shall
include--
``(A) a description of methods established to assess
progress of the Office of Intelligence and Analysis in
implementing this section; and
``(B) such assessment.
``SEC. 2102. RISK ASSESSMENTS.
``(a) In General.--The Secretary, acting through the Under Secretary
for Science and Technology, shall, in coordination with relevant
Department components and other appropriate Federal departments and
agencies--
``(1) produce and update periodically a terrorism risk
assessment of chemical, biological, radiological, and nuclear
threats; and
``(2) produce and update periodically an integrated terrorism
risk assessment that assesses all of those threats and compares
them against one another according to their relative risk.
``(b) Methodology.--
``(1) In general.--The Secretary shall--
``(A) convene an interagency task force of relevant
subject matter experts to assess the proposed
methodology to be used for assessments required under
subsection (a), and to provide recommendations to the
Secretary as to the adequacy of such methodology;
``(B) conduct sensitivity analysis on each assessment
to identify and prioritize research activities to close
knowledge gaps; and
``(C) consider the evolving threat from an
intelligent adversary.
``(2) Inclusion in assessment.--Each assessment under
subsection (a) shall include a description of the methodology
used for the assessment.
``(c) Usage.--The assessments required under subsection (a) shall be
used to inform and guide risk management decisions, including--
``(1) the threat assessments and determinations by the
Secretary regarding agents and toxins pursuant to section 319F-
2 of the Public Health Service Act;
``(2) allocation of resources for research and development
for chemical, biological, radiological, and nuclear attack
prevention, protection, response, and recovery;
``(3) prioritization of medical countermeasure research,
development, acquisition, and distribution activities and other
national strategic biodefense research;
``(4) tailored risk assessments and risk mitigation studies,
as appropriate, on topics such as radiological materials
security or the economic risks of a biological attack; and
``(5) other homeland security activities as determined
appropriate by the Secretary and the heads of other agencies.
``(d) Input and Sharing.--The Secretary shall, for each assessment
required under subsection (a)--
``(1) seek input from national biosecurity and biodefense
stakeholders, and other Federal, State, local, and tribal
officials involved in efforts to prevent, protect, respond to,
and recover from chemical, biological, radiological, and
nuclear threats;
``(2) ensure that written procedures are in place to guide
the interagency development of the assessments, including for
input, review, and implementation purposes, among relevant
Federal partners;
``(3) share the risk assessments with Federal, State, local
and tribal officials with appropriate security clearances and a
need for the information in the classified version; and
``(4) to the maximum extent practicable, make available an
unclassified version for Federal, State, local, and tribal
officials involved in prevention and preparedness for chemical,
biological, radiological, and nuclear events.
``(e) Written Procedures.--The Secretary shall establish written
procedures for appropriate usage of the assessments required under
subsection (a), including--
``(1) a description of the types of departmental activities
for which the assessments should be considered;
``(2) the extent to which the findings of the assessments
should play a role in such activities;
``(3) the point in planning processes at which the
assessments should be considered; and
``(4) how users can access expertise within the Department to
aid in interpretation of the results of the assessments.
``SEC. 2103. NATIONAL EXPORT ENFORCEMENT COORDINATION.
``(a) Establishment.--There shall be maintained in the Department the
Export Enforcement Coordination Center, with capability for national
export enforcement coordination that is managed by the Secretary and
coordinates the export enforcement activities among the Department, the
Department of Agriculture, the Department of Commerce, the Department
of Defense, the Department of Energy, the Department of Justice, the
Department of State, the Department of the Treasury, the Intelligence
Community, and other Federal agencies as appropriate.
``(b) Responsibilities.--The Center shall--
``(1) enhance Federal coordination for law enforcement
counterproliferation investigations, including coordination and
deconfliction with intelligence counterproliferation
activities;
``(2) address licensing inquiries, reviews, requests, checks,
and verifications; and
``(3) conduct outreach and provide training to the export
trade community.
``SEC. 2104. COMMUNICATION OF THREAT INFORMATION.
``(a) Findings.--Congress finds the following:
``(1) The Commission on the Prevention of Weapons of Mass
Destruction Proliferation and Terrorism recommended that `the
Federal Government should practice greater openness of public
information so that citizens better understand the threat and
the risk this threat poses to them'.
``(2) There are unique challenges for community preparedness
for attacks from weapons of mass destruction.
``(b) Communications Plan.--
``(1) In general.--The Administrator of the Federal Emergency
Management Agency shall develop a communications plan designed
to provide information to the public related to preventing,
preparing for, responding to, and recovering from chemical,
biological, radiological, and nuclear attacks;
``(2) Consultation.--As appropriate, the Administrator of the
Federal Emergency Management Agency shall consult with State,
local, and tribal authorities and coordinate with other Federal
departments and agencies in developing the communications plans
under paragraph (1).
``(3) Pre-scripted messages and message templates.--
``(A) In general.--The Administrator of the Federal
Emergency Management Agency shall develop and
disseminate, through an alerts and warnings system,
pre-scripted messages and message templates for State,
local, and tribal authorities so that those authorities
can quickly and rapidly disseminate critical
information to the public in anticipation of, during,
or in the immediate aftermath of a chemical,
biological, radiological, and nuclear attack, and to be
included in the Department of Homeland Security's
lessons learned information sharing system.
``(B) Development and design.--The pre-scripted
messages or message templates shall--
``(i) be developed in consultation with
State, local, and tribal authorities and in
coordination with other appropriate Federal
departments and agencies;
``(ii) be designed to provide accurate,
essential, and appropriate information and
instructions to the population directly
affected by an incident, including information
regarding an evacuation, sheltering in place,
hospital surge operations, health, and safety;
``(iii) be designed to provide accurate,
essential, and appropriate information and
instructions to children and other special
needs populations within the population
directly affected by an incident;
``(iv) be designed to provide accurate,
essential, and appropriate information and
instructions to emergency response providers
and medical personnel responding to an
incident; and
``(v) include direction for the coordination
of Federal, State, local, and tribal
communications teams.
``(C) Communications formats.--The Administrator
shall develop pre-scripted messages or message
templates under this paragraph in multiple formats to
ensure delivery--
``(i) in cases where the usual communications
infrastructure is unusable;
``(ii) to individuals with disabilities or
other special needs and individuals with
limited English proficiency; and
``(iii) to educational and childcare
facilities, including daycare centers, grade
schools, universities, hospitals, and elderly
care facilities.
``(D) Dissemination and technical assistance.--The
Administrator shall ensure that all pre-scripted
messages and message templates developed under this
paragraph are made available to State, local, and
tribal authorities so that those authorities may
incorporate them, as appropriate, into their emergency
plans. The Administrator shall also make available
relevant technical assistance to those authorities to
support communications planning.
``(E) Exercises.--To ensure that the pre-scripted
messages or message templates developed under this
paragraph can be effectively utilized in a disaster or
incident, the Administrator shall incorporate Federal,
State, local, and tribal communications teams that
deliver such pre-scripted messages or message templates
into exercises, including those conducted under the
National Exercise Program.
``(4) Report.--Not later than 1 year after the date of the
enactment of this subsection, the Administrator of the Federal
Emergency Management Agency shall submit to the appropriate
congressional committees the communications plans required to
be developed under this subsection, including pre-scripted
messages or message templates developed in conjunction with the
plans and a description of the means that will be used to
deliver these messages during such incidents.
``(c) Terrorism Threat Awareness.--
``(1) Terrorism threat awareness.--The Secretary, in
coordination with the Attorney General and heads of appropriate
Federal agencies, shall for purposes of preparedness and
collective response to terrorism and for other purposes--
``(A) ensure that homeland security information
concerning terrorist threats is provided to State,
local, and tribal authorities and the public within the
United States, as appropriate; and
``(B) establish a process to optimize opportunities
for qualified heads of State, local, and tribal
government entities to obtain appropriate security
clearances so that they may receive classified threat
information when appropriate.
``(2) Threat bulletins.--
``(A) In general.--Consistent with the requirements
of paragraph (1), the Secretary shall, on a timely
basis, prepare unclassified threat bulletins on
chemical, biological, radiological, and nuclear
threats.
``(B) Requirements.--Each assessment required under
subparagraph (A) shall--
``(i) include guidance to the public for
preventing and responding to acts of terrorism
arising from such threats; and
``(ii) be made available on the Internet Web
site of the Department and other publicly
accessible Internet Web sites, communication
systems, and information networks.
``(3) Guidance to state, local, and tribal authorities.--The
Secretary, using information provided by the terrorism risk
assessments under section 2102 and material threat assessments
and determinations under the Project BioShield Act of 2004
(Public Law 108-276) and the amendments made by that Act--
``(A) shall provide to State, local, and tribal
authorities written guidance on communicating
terrorism-related threats and risks to the public
within their jurisdictions; and
``(B) shall identify and articulate the governmental
rationale for identifying particular communities as
being at heightened risk of exploitation.
``(4) Use of existing resources.--The Secretary shall use
Internet Web sites, communication systems, and information
networks in operation on the date of an assessment under this
subsection, and shall coordinate with other heads of Federal
departments and agencies to provide information through
existing channels to satisfy the requirements of paragraph
(2)(B)(ii). The Secretary shall provide guidance on how State,
local, tribal, and private entities can partner with public
television stations to disseminate information provided by the
Department and shall provide information on best practices on
disseminating information to residents of local communities,
including leveraging public television stations.
``SEC. 2105. INDIVIDUAL AND COMMUNITY PREPAREDNESS FOR CHEMICAL,
BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR ATTACKS.
``(a) In General.--The Secretary, acting through the Administrator
for the Federal Emergency Management Agency, shall assist State, local,
and tribal authorities in improving and promoting individual and
community preparedness and collective response to terrorist attacks
involving chemical, biological, radiological, and nuclear materials
against the United States by--
``(1) developing guidance and checklists of recommended
actions for individual and community prevention and
preparedness efforts and disseminating such guidance and
checklists to communities and individuals;
``(2) updating new and existing guidance and checklists as
appropriate;
``(3) disseminating to communities and individuals the
guidance developed under section 2131, as appropriate;
``(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 Secretary determines
appropriate.
``(b) Coordination.--The Secretary shall coordinate with Federal
departments and agencies and with private sector and nongovernmental
organizations to promote individual and community preparedness and
collective response to terrorist attacks involving chemical,
biological, radiological, and nuclear materials against the United
States.
``(c) Best Practices.--In compiling guidance for individual and
community preparedness in order to carry out subsection (a)(4), the
Secretary shall give due regard to best practices based on the
experience of other agencies and countries and the expertise of
academic institutions and nongovernmental organizations.
``Subtitle B--Protection
``SEC. 2121. DETECTION OF BIOLOGICAL ATTACKS.
``(a) Program.--The Secretary shall carry out a program to detect a
biological attack or event that poses a high risk to homeland security.
Through such program, the Secretary shall--
``(1) deploy detection capabilities to areas, based on high
risks identified by Department assessments, to indicate the
presence of biological agents;
``(2) consider multiple deployment strategies including surge
capability;
``(3) provide information to participating laboratories and
programs for their use in monitoring public health, and
biological material or other data from those detectors to
participating laboratories and programs for testing and
evaluation;
``(4) regularly communicate with, and provide information
about the presence of biological agents to, appropriate
Federal, State, and local agencies responsible for public
health, law enforcement, and emergency services, in a manner
that ensures transparency with the governments served by such
personnel;
``(5) provide advanced planning tools, concepts of operations
(including alarm resolution protocols and response guidance),
standard operating procedures, and training exercises
(including in collaboration with relevant national level
exercises) for collective response to and recovery from
biological attacks; and
``(6) provide technical assistance to jurisdictions hosting
the program to improve their ability to respond to a detected
pathogen.
``(b) Program Requirements.--Under the program required under
subsection (a), the Secretary shall--
``(1) enter into memoranda of agreement or interagency
agreements under the Economy Act of 1933 (31 U.S.C. 1535 et
seq.) with the Director of the Centers of Disease Control and
Prevention and the Administrator of the Environmental
Protection Agency, and the heads of other Federal departments
and agencies, setting forth roles and responsibilities,
including with respect to validating performance and developing
testing protocols for participating laboratories and
coordination with appropriate State, local, and tribal
agencies;
``(2) establish criteria for determining whether plans for
biological detector capabilities and coverage sufficiently
protect the United States population, and make such
determinations on an annual basis;
``(3) acting through the Under Secretary for Science and
Technology, and in consultation with the Director of the
Centers for Disease Control and Prevention, implement a process
for establishing assay performance standards and evaluation for
equivalency for biological threat assays, that--
``(A) evaluates biological threat detection assays,
their protocols for use, and their associated response
algorithms for confirmation of biological threat
agents, taking performance measures and concepts of
operation into consideration;
``(B) develops interagency peer-reviewed assay
performance and equivalency standards based on the
findings of the evaluation under subparagraph (A);
``(C) requires implementation of the standards
developed under subparagraph (B) for all Department
biological detection programs;
``(D) promotes use of such standards among all other
Federal biological detection programs and makes them
available to the private sector and other end-users as
appropriate; and
``(E) is updated as necessary;
``(4) prior to obligating funds to acquire biodetection
systems for purposes of operational testing and evaluation,
require--
``(A) a determination of the sensitivity and
specificity of the currently deployed biodetection
system;
``(B) an assessment of the sensitivity and
specificity of the next generation biodetection system
or systems under consideration for acquisition and
whether it meets established operational requirements;
``(C) provision of all raw data to the Science and
Technology Directorate to enable the Under Secretary
to--
``(i) conduct a trade-off study comparing the
results of subparagraphs (A) and (B); and
``(ii) perform a technical readiness
assessment in accordance with section 308(b);
and
``(D) that the findings under subparagraph (C) inform
the cost-benefit analysis under paragraph (5)(A) and
any Departmental acquisition review board decision
regarding the biodetection system or systems under
consideration; and
``(5) prior to acquiring and deploying biodetection
technology, require--
``(A) a cost-benefit analysis, including an analysis
of alternatives, that shall be informed by the
terrorism risk assessments under section 2102;
``(B) operational testing and evaluation;
``(C) operational assessment by the end users of the
technology; and
``(D) the Department, other relevant executive
agencies, and local jurisdictions intended to host the
systems to agree on concepts of operations for
resolving alarms.
``(c) Contract Authority.--The Secretary may enter into contracts
with participating laboratories and programs for--
``(1) the provision of laboratory services or other
biosurveillance activities as appropriate for purposes of this
section on a fee-for-service basis or on a prepayment or other
similar basis; and
``(2) administrative and other costs related to hosting
program personnel and equipment in these laboratories or
programs.
``(d) Definitions.--In this section:
``(1) The term `participating laboratory' means a laboratory
that has been accepted as a member of the Laboratory Response
Network for Biological Terrorism that--
``(A) is fully equipped to detect and respond quickly
to acts of biological terrorism;
``(B) provides biocontainment and microbiological
analysis in support of the Department and relevant law
enforcement agencies with responsibilities for
investigating biological incidents; and
``(C) supports assay evaluation, research and
development.
``(2) The term `assay' means any scientific test that is
designed to detect the presence of a biological threat agent
that is of a type selected under criteria established by the
Secretary.
``SEC. 2122. RAPID BIOLOGICAL THREAT DETECTION AND IDENTIFICATION AT
PORTS OF ENTRY.
``(a) In General.--The Secretary of Homeland Security shall require
the Under Secretary for Science and Technology, in consultation with
the heads of other relevant operational components of the Department of
Homeland Security, to assess whether the development of technological
screening capabilities for biological agents, pandemic influenza, and
other infectious diseases should be undertaken by the Directorate of
Science and Technology to support entry and exit screening at ports of
entry and for other homeland security purposes.
``(b) Development of Methods.--If the Under Secretary determines that
the development of such screening capabilities should be undertaken,
the Secretary shall, to the extent possible, initiate development of
safe and effective methods to--
``(1) rapidly screen incoming persons at ports of entry for
biological agents, pandemic influenza, and other infectious
diseases; and
``(2) obtain results of such screening near the point of
entry.
``SEC. 2123. EVALUATING DETECTION TECHNOLOGY.
``To inform the purchase of detection technology, the Secretary, in
coordination with the Director of the National Institute of Standards
and Technology, may carry out a program to--
``(1) establish near-term minimum performance metrics to
support public safety actionable activities, based to the
greatest extent practicable on voluntary consensus standards,
to evaluate the effectiveness of detection technology for high-
priority biological agents and toxins and high-priority
chemical agents;
``(2) establish a process for voluntary testing and
evaluation of technology by an accredited laboratory to
demonstrate conformance to such consensus standards, or
performance metrics if standards do not exist, for the
effective detection of high-priority biological agents and
toxins and high-priority chemical agents, including
incentivization for the program through potential cost sharing
with technology manufacturers and for SAFETY Act certification
or placement on the authorized equipment list, or both; and
``(3) with permission from the detection technology
manufacturer, make available to Federal departments and
agencies, State, territorial, local, and tribal entities, and
the private sector the results of detection system testing and
evaluation under paragraph (2).
``SEC. 2124. DOMESTIC IMPLEMENTATION OF THE GLOBAL NUCLEAR DETECTION
ARCHITECTURE.
``(a) Securing the Cities.--The Director of the Domestic Nuclear
Detection Office shall establish and maintain a multilayered system of
detection technologies, programs, and guidelines designed to enhance
the Nation's ability to detect and prevent a radiological or nuclear
attack in high-risk United States cities, as determined by the
Secretary.
``(b) Surge Capabilities.--The Director shall develop a surge
capability for radiological and nuclear detection systems that can be
deployed within the United States rapidly in response to actionable
intelligence or warnings, and includes procurement of appropriate
technology, training, and exercises.
``(c) Integration.--The programs under subsections (a) and (b) shall
be integrated into the Global Nuclear Detection Architecture and shall
inform architecture studies, technology gaps, and research activities
of the Domestic Nuclear Detection Office.
``Subtitle C--Response
``SEC. 2131. FIRST RESPONDER GUIDANCE CONCERNING CHEMICAL, BIOLOGICAL,
RADIOLOGICAL, AND NUCLEAR ATTACKS.
``(a) Establishment of Voluntary Guidance.--Not later than 1 year
after the date of the enactment of this section, the Secretary, in
coordination with the Secretary of Health and Human Services, the
Secretary of Agriculture, the Administrator of the Environmental
Protection Agency, the Attorney General, and the heads of other Federal
departments and agencies, as appropriate, shall--
``(1) develop for police, fire, emergency medical services,
emergency management, and medical and public health personnel,
voluntary guidance for responding to a release of chemical,
biological, radiological, and nuclear material;
``(2) make such guidance available to State, local, and
tribal authorities, including primary and secondary schools and
other educational institutions, nongovernmental organizations,
the private sector, and the public; and
``(3) in developing the guidance under paragraph (1)--
``(A) review the experiences of other countries and
the expertise of academic institutions and
nongovernmental organizations; and
``(B) consider the unique needs of children and other
vulnerable populations.
``(b) Contents.--The guidance developed under subsection (a)(1) shall
be voluntary, risk-based guidance that shall include--
``(1) protective action guidance for ensuring the security,
health, and safety of emergency response providers and their
families and household contacts;
``(2) specific information regarding the effects of the
chemical, biological, radiological, or nuclear material on
those exposed to the agent; and
``(3) best practices for emergency response providers to
effectively diagnose, handle, and otherwise manage individuals
affected by an incident involving chemical, biological,
radiological, or nuclear material.
``(c) Review and Revision of Guidance.--The Secretary shall--
``(1) review the guidance developed under subsection (a)(1)
at least once every 2 years;
``(2) make revisions to the guidance as appropriate; and
``(3) make any revised guidance available to State, local,
and tribal authorities, nongovernmental organizations, the
private sector, and the public.
``(d) Procedures for Developing and Revising Guidance.--In carrying
out the requirements of this section, the Secretary shall establish
procedures to--
``(1) enable members of the first responder and first
provider community to submit recommendations of areas in which
guidance is needed and could be developed under subsection
(a)(1);
``(2) determine which entities should be consulted in
developing or revising the guidance;
``(3) prioritize, on a regular basis, guidance that should be
developed or revised; and
``(4) develop and disseminate the guidance in accordance with
the prioritization under paragraph (3).
``SEC. 2132. INTEGRATED PLUME MODELING FOR COLLECTIVE RESPONSE.
``(a) Development.--
``(1) In general.--The Secretary shall acquire, use, and
disseminate the best available integrated plume models to
enable rapid response activities following a chemical,
biological, nuclear, or radiological attack or event.
``(2) Scope.--The Secretary shall--
``(A) identify Federal, State, and local needs
regarding plume models and ensure the rapid development
and distribution of integrated plume models that meet
those needs to appropriate officials of the Federal
Government and State, local, and tribal authorities to
enable immediate response to a chemical, biological,
radiological, or nuclear attack or event;
``(B) establish mechanisms for dissemination by
appropriate emergency response officials of the
integrated plume models described in paragraph (1) to
nongovernmental organizations and the public to enable
appropriate collective response activities;
``(C) ensure that guidance and training in how to
appropriately use such models are provided; and
``(D) ensure that lessons learned from assessing the
development and dissemination of integrated plume
models during exercises administered by the Department
are put into the lessons learned information sharing
system maintained by the Department.
``(b) Definitions.--For purposes of this section:
``(1) The term `plume model' means the assessment of the
location and prediction of the spread of agents following a
chemical, biological, radiological, or nuclear attack or event.
``(2) The term `integrated plume model' means a plume model
that integrates protective action guidance and other
information as the Secretary determines appropriate.
``SEC. 2133. ESTABLISHMENT OF THE SYSTEM ASSESSMENT AND VALIDATION FOR
EMERGENCY RESPONDERS (SAVER) PROGRAM.
``The Secretary shall carry out a program for system assessment and
validation of emergency response equipment at the Department, to be
known as the `SAVER Program'. The Secretary shall ensure that such
program--
``(1) conducts objective, impartial, practitioner-relevant,
and operationally oriented assessments and validations of
commercial emergency responder equipment and systems, including
hand-held detectors for chemical, biological, radiological, and
nuclear agents;
``(2) prioritizes such evaluation based on the technical
results obtained from the program established under section
2123, if available;
``(3) is supported by a network of scientists who, in
coordination with subject matter experts, perform the
assessment and validation activities using strict scientific
and testing protocols;
``(4) provides results along with other relevant equipment
information to the emergency response provider community in an
operationally useful form;
``(5) provides information on equipment that falls within the
categories listed in the Department's authorized equipment
list;
``(6) provides information that enables decision-makers and
responders to better select, procure, use, and maintain
emergency responder equipment; and
``(7) shares such information nationally with the emergency
response provider community.
``SEC. 2134. PAYMENT FOR LABORATORY RESPONSE SERVICES.
``In carrying out their functions, responsibilities, authorities, and
duties to counter biological terrorism, the Secretary, the Attorney
General, and the heads of other participating Federal agencies are
authorized, subject to the availability of appropriations, to enter
into contracts with laboratories that comprise the Laboratory Response
Network for Biological Terrorism and other federally networked
laboratories that agree to participate in such a contract, for the
provision of laboratory testing services on a fee-for-service basis or
on a prepayment or other similar basis. Prior to entering into such a
contract with any laboratory in the Laboratory Response Network for
Biological Terrorism, the Secretary, the Attorney General, or the head
of any other participating Federal agency shall inform the Centers for
Disease Control and Prevention.
``SEC. 2135. BIOFORENSICS CAPABILITIES.
``(a) Bioforensics Analysis Center.--There is authorized in the
Department a bioforensics analysis center to provide support for law
enforcement and intelligence-related investigations and actions to--
``(1) provide definitive bioforensics analysis in support of
the executive agencies with primary responsibilities for
preventing, deterring, responding to, attributing, and
recovering from biological attacks; and
``(2) undertake other related bioforensics activities.
``(b) Payment for Services.--The center shall charge and retain fees
to reimburse the cost of any service provided to an executive agency
that requested such service.
``(c) Detailee Program.--Subject to the availability of
appropriations, the Secretary may implement a program under which
executive agencies as considered appropriate by the Secretary provide
personnel, on a reimbursable basis, to the center for the purpose of--
``(1) providing training and other educational benefits for
such stakeholders to help them to better understand the
policies, procedures, and laws governing national bioforensics
activities; and
``(2) bolstering the capabilities and information sharing
activities of the bioforensics analysis center authorized under
subsection (a) with national biosecurity and biodefense
stakeholders.
``SEC. 2136. METROPOLITAN MEDICAL RESPONSE SYSTEM PROGRAM.
``(a) In General.--The Secretary shall conduct a Metropolitan Medical
Response System Program, that shall assist State and local governments
in preparing for and responding to public health and mass casualty
incidents resulting from acts of terrorism, natural disasters, and
other man-made disasters.
``(b) Financial Assistance.--
``(1) Authorization of grants.--
``(A) In general.--The Secretary, through the
Administrator of the Federal Emergency Management
Agency, may make grants under this section to State and
local governments to assist in preparing for and
responding to mass casualty incidents resulting from
acts of terrorism, natural disasters, and other man-
made disasters.
``(B) Consultation.--In developing guidance for
grants authorized under this section, the Administrator
shall consult with the Chief Medical Officer.
``(2) Use of funds.--A grant made under this section may be
used to support the integration of emergency management,
health, and medical systems into a coordinated response to mass
casualty incidents caused by any hazard, including--
``(A) to strengthen medical surge capacity;
``(B) to strengthen mass prophylaxis capabilities
including development and maintenance of an initial
pharmaceutical stockpile sufficient to protect first
responders, their families, and immediate victims from
a chemical or biological event, including the
procurement of home medical kits that are approved
pursuant to the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.) or the Public Health Service
Act (42 U.S.C. 201 et seq.), as applicable;
``(C) to strengthen chemical, biological,
radiological, nuclear, and explosive detection,
response, and decontamination capabilities;
``(D) to develop and maintain mass triage and pre-
hospital treatment plans and capabilities;
``(E) for planning;
``(F) to support efforts to strengthen information
sharing and collaboration capabilities of regional,
State, and urban areas in support of public health and
medical preparedness;
``(G) for medical supplies management and
distribution;
``(H) for training and exercises;
``(I) for integration and coordination of the
activities and capabilities of public health personnel
and medical care providers with those of other
emergency response providers as well as other Federal
agencies, the private sector, and nonprofit
organizations, for the forward movement of patients;
and
``(J) for such other activities as the Administrator
provides.
``(3) Eligibility.--
``(A) In general.--Except as provided in subparagraph
(C), any jurisdiction that received funds through the
Metropolitan Medical Response System Program in fiscal
year 2009 shall be eligible to receive a grant under
this section.
``(B) Additional jurisdictions.--
``(i) Unrepresented states.--
``(I) In general.--Except as provided
in subparagraph (C), the Administrator
may make grants under this section to
the metropolitan statistical area with
the largest population in any State in
which no jurisdiction received funds
through the Metropolitan Medical
Response Program in fiscal year 2009,
or in which funding was received only
through another State.
``(II) Limitation.--For each of
fiscal years 2012 through 2014, no
jurisdiction that would otherwise be
eligible to receive grants under
subclause (I) shall receive a grant
under this section if it would result
in any jurisdiction under subparagraph
(A) receiving less funding than such
jurisdiction received in fiscal year
2009.
``(ii) Other jurisdictions.--
``(I) In general.--Subject to
subparagraph (C), the Administrator may
determine that additional jurisdictions
are eligible to receive grants under
this section.
``(II) Limitation.--For each of
fiscal years 2012 through 2014, the
eligibility of any additional
jurisdiction to receive grants under
this section is subject to the
availability of appropriations beyond
that necessary to--
``(aa) ensure that each
jurisdiction eligible to
receive a grant under
subparagraph (A) does not
receive less funding than such
jurisdiction received in fiscal
year 2009; and
``(bb) provide grants to
jurisdictions eligible under
clause (i).
``(C) Performance requirement after fiscal year
2012.--A jurisdiction shall not be eligible for a grant
under this subsection from funds available after fiscal
year 2012 unless the Secretary determines that the
jurisdiction maintains a sufficient measured degree of
capability in accordance with the performance measures
issued under subsection (c).
``(4) Distribution of funds.--
``(A) In general.--The Administrator shall distribute
grant funds under this section to the State in which
the jurisdiction receiving a grant under this section
is located.
``(B) Pass through.--Subject to subparagraph (C), not
later than 45 days after the date on which a State
receives grant funds under subparagraph (A), the State
shall provide the jurisdiction receiving the grant 100
percent of the grant funds, and not later than 45 days
after the State releases the funds, all fiscal agents
shall make the grant funds available for expenditure.
``(C) Exception.--The Administrator may permit a
State to provide to a jurisdiction receiving a grant
under this section 97 percent of the grant funds
awarded if doing so would not result in any
jurisdiction eligible for a grant under paragraph
(3)(A) receiving less funding than such jurisdiction
received in fiscal year 2009.
``(5) Regional coordination.--The Administrator shall ensure
that each jurisdiction that receives a grant under this
section, as a condition of receiving such grant, is actively
coordinating its preparedness efforts with surrounding
jurisdictions, with the official with primary responsibility
for homeland security (other than the Governor) of the
government of the State in which the jurisdiction is located,
and with emergency response providers from all relevant
disciplines, as determined by the Administrator, to effectively
enhance regional preparedness.
``(c) Performance Measures.--The Administrator of the Federal
Emergency Management Agency, in coordination with the Chief Medical
Officer, and the National Metropolitan Medical Response System Working
Group, shall issue performance measures within 1 year after the date of
enactment of this section that enable objective evaluation of the
performance and effective use of funds provided under this section in
any jurisdiction.
``(d) Metropolitan Medical Response System Working Group Defined.--In
this section, the term `National Metropolitan Medical Response System
Working Group' means--
``(1) 10 Metropolitan Medical Response System Program grant
managers, who shall--
``(A) include 1 such grant manager from each region
of the Agency;
``(B) comprise a population-based cross section of
jurisdictions that are receiving grant funds under the
Metropolitan Medical Response System Program; and
``(C) include--
``(i) 3 selected by the Administrator of the
Federal Emergency Management Agency; and
``(ii) 3 selected by the Chief Medical
Officer; and
``(2) 3 State officials who are responsible for
administration of State programs that are carried out with
grants under this section, who shall be selected by the
Administrator.
``(e) Authorization of Appropriations.--There is authorized to be
appropriated $42,000,000 to carry out the program for each of fiscal
years 2012 through 2016.
``Subtitle D--Recovery
``SEC. 2141. IDENTIFYING AND ADDRESSING GAPS IN RECOVERY CAPABILITIES.
``(a) Risk Assessment.--
``(1) Tailored risk assessment.--The Secretary, acting
through the Under Secretary for Science and Technology and in
coordination with the Administrator of the Environmental
Protection Agency, shall conduct tailored risk assessments to
inform prioritization of national recovery activities for
chemical, biological, radiological, and nuclear incidents, to
be updated as necessary.
``(2) Considerations.--In conducting the risk assessments
under paragraph (1), the Secretary shall--
``(A) consult with the Secretary of Health and Human
Services, the Secretary of Agriculture, the Secretary
of the Interior, the Chairman of the Nuclear Regulatory
Commission, and the heads of other relevant Federal
departments and agencies;
``(B) consider recovery of both indoor areas and
outdoor environments; and
``(C) consider relevant studies previously prepared
by other Federal agencies, or other appropriate
stakeholders.
``(3) Collaboration.--Upon completion of the risk assessments
required by this section, the Secretary shall provide the
findings to the Administrator of the Environmental Protection
Agency and heads of other relevant Federal agencies in order to
inform ongoing and future work, including research and guidance
development, undertaken by those agencies in recovery and
remediation from chemical, biological, radiological, or nuclear
incidents.
``(b) Research.--The results of the risk assessment under this
section shall inform appropriate Federal research to address the high-
risk capability gaps uncovered by each assessment.
``(c) Submission to Congress.--The results of each risk assessment
shall be submitted to the appropriate congressional committees within
30 days after completion of the assessment.
``SEC. 2142. RECOVERY FROM A CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND
NUCLEAR ATTACK OR INCIDENT.
``(a) Establishment of Guidance.--The Secretary shall develop and
issue guidance for clean-up and restoration of indoor and outdoor
areas, including subways and other mass transportation facilities, that
have been exposed to chemical, biological, radiological, or nuclear
materials. The Secretary shall develop and issue the guidance, within
24 months after the date of enactment of this section, in consultation
with--
``(1) the Secretary of Agriculture;
``(2) the Secretary of Commerce;
``(3) the Secretary of Education;
``(4) the Secretary of the Interior;
``(5) the Attorney General;
``(6) the Secretary of Labor;
``(7) the Secretary of Transportation;
``(8) the Secretary of Housing and Urban Development;
``(9) the Secretary of Health and Human Services;
``(10) the Secretary of Veterans Affairs;
``(11) the Secretary of the Treasury;
``(12) the Administrator of the Environmental Protection
Agency; and
``(13) the Administrator of the Small Business
Administration.
``(b) Contents.--The guidance developed under subsection (a) shall
clarify Federal roles and responsibilities for assisting State, local,
and tribal authorities and include risk-based recommendations for--
``(1) standards for effective decontamination of affected
sites;
``(2) standards for safe post-event occupancy of affected
sites, including for vulnerable populations such as children
and individuals with health concerns;
``(3) requirements to ensure that the decontamination
procedures for responding organizations do not conflict;
``(4) requirements that each responding organization uses a
uniform system for tracking costs and performance of clean-up
contractors;
``(5) maintenance of negative air pressure in buildings;
``(6) standards for proper selection and use of personal
protective equipment;
``(7) air sampling procedures;
``(8) development of occupational health and safety plans
that are appropriate for the specific risk to responder health;
and
``(9) waste disposal.
``(c) Review and Revision of Guidance.--The Secretary shall--
``(1) not less frequently than once every 2 years, review the
guidance developed under subsection (a);
``(2) make revisions to the guidance as appropriate; and
``(3) make the revised guidance available to the Federal
Government, State, local, and tribal authorities,
nongovernmental organizations, the private sector, and the
public.
``(d) Procedures for Developing and Revising Guidance.--In carrying
out the requirements of this section, the Secretary shall establish
procedures to--
``(1) prioritize issuance of guidance based on the results of
the risk assessment under section 2131;
``(2) inventory existing relevant guidance;
``(3) enable the public to submit recommendations of areas in
which guidance is needed;
``(4) determine which entities should be consulted in
developing or revising the guidance;
``(5) prioritize, on a regular basis, guidance that should be
developed or revised; and
``(6) develop and disseminate the guidance in accordance with
the prioritization under paragraph (5).
``(e) Consultations.--The Secretary shall develop and revise the
guidance developed under subsection (a), and the procedures required
under subsection (d), in consultation with--
``(1) the heads of other Federal departments and agencies
that are not required to be consulted under subsection (a), as
the Secretary considers appropriate;
``(2) State, local, and tribal authorities; and
``(3) nongovernmental organizations and private industry.
``(f) Report.--Not later than 1 year after the date of the enactment
of this section, and annually thereafter, the Secretary shall provide
appropriate congressional committees with--
``(1) a description of the procedures established under
subsection (d);
``(2) any guidance in effect on the date of the report;
``(3) a list of entities to which the guidance described in
paragraph (2) was disseminated;
``(4) a plan for reviewing the guidance described in
paragraph (2), in accordance with subsection (e);
``(5) the prioritized list of the guidance required under
subsection (d)(4), and the methodology used by the Secretary
for such prioritization; and
``(6) a plan for developing, revising, and disseminating the
guidance.
``SEC. 2143. EXERCISES.
``(a) In General.--To facilitate recovery from a chemical,
biological, radiological, or nuclear attack or other incident involving
chemical, biological, radiological, or nuclear materials and to foster
collective response to terrorism, the Secretary shall develop exercises
in consultation with State, local, and tribal authorities and other
appropriate Federal agencies, and, as appropriate, in collaboration
with national level exercises, including exercises that address, to the
best knowledge available at the time, analysis, indoor environmental
cleanup methods, and decontamination standards, including those
published in the guidance issued under section 2142.
``(b) Lessons Learned for National Level Exercises.--The Secretary
shall provide electronically, to the maximum extent practicable,
lessons learned reports to each designated representative of State,
local, and tribal jurisdictions and private sector entities that
participate in National Level Exercises of the Department. Each lessons
learned report shall be tailored to convey information on that exercise
that could be leveraged to enhance preparedness and response.''.
(b) Clerical Amendment.--The table of contents in section 1(b) of
such Act is amended by adding at the end the following new items:
``TITLE XXI--WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS
``Subtitle A--Prevention
``Sec. 2101. Weapons of mass destruction intelligence and information
sharing.
``Sec. 2102. Risk assessments.
``Sec. 2103. National Export Enforcement Coordination.
``Sec. 2104. Communication of threat information.
``Sec. 2105. Individual and community preparedness for chemical,
biological, radiological, and nuclear attacks.
``Subtitle B--Protection
``Sec. 2121. Detection of biological attacks.
``Sec. 2122. Rapid biological threat detection and identification at
ports of entry.
``Sec. 2123. Evaluating detection technology.
``Sec. 2124. Domestic implementation of the Global Nuclear Detection
Architecture.
``Subtitle C--Response
``Sec. 2131. First responder guidance concerning chemical, biological,
radiological, and nuclear attacks.
``Sec. 2132. Integrated plume modeling for collective response.
``Sec. 2133. Establishment of the system assessment and validation for
emergency responders (SAVER) program.
``Sec. 2134. Payment for laboratory response services.
``Sec. 2135. Bioforensics capabilities.
``Sec. 2136. Metropolitan Medical Response System Program.
``Subtitle D--Recovery
``Sec. 2141. Identifying and addressing gaps in recovery capabilities.
``Sec. 2142. Recovery from a chemical, biological, radiological, and
nuclear attack or incident.
``Sec. 2143. Exercises.''.
(c) Conforming Amendment.--Section 316 of the Homeland Security Act
of 2002 (6 U.S.C. 195b), and the item relating to such section in
section 1(b) of such Act, are repealed.
(d) Metropolitan Medical Response Program Review.--
(1) In general.--The Administrator of the Federal Emergency
Management Agency, the Chief Medical Officer of the Department
of Homeland Security, and the National Metropolitan Medical
Response System Working Group shall conduct a review of the
Metropolitan Medical Response System Program authorized under
section 2136 of the Homeland Security Act of 2002, as added by
this section, including an examination of--
(A) the extent to which the program goals and
objectives are being met;
(B) the performance metrics that can best help assess
whether the Metropolitan Medical Response System
Program is succeeding;
(C) how the Metropolitan Medical Response System
Program can be improved;
(D) how the Metropolitan Medical Response System
Program complements and enhances other preparedness
programs supported by the Department of Homeland
Security and the Department of Health and Human
Services;
(E) the degree to which the strategic goals,
objectives, and capabilities of the Metropolitan
Medical Response System Program are incorporated in
State and local homeland security plans;
(F) how eligibility for financial assistance, and the
allocation of financial assistance, under the
Metropolitan Medical Response System Program should be
determined, including how allocation of assistance
could be based on risk;
(G) implications for the Metropolitan Medical
Response System Program if it were managed as a
contractual agreement; and
(H) the resource requirements of the Metropolitan
Medical Response System Program.
(2) Report.--Not later than 1 year after the date of
enactment of this Act, the Administrator and the Chief Medical
Officer shall submit to the Committee on Homeland Security of
the House of Representatives and the Committee on Homeland
Security and Governmental Affairs of the Senate a report on the
results of the review under this section.
(3) Consultation.--The Administrator of the Federal Emergency
Management Agency shall consult with the Secretary of Health
and Human Services in the implementation of paragraph (1)(E).
(4) Definition.--In this subsection the term ``National
Metropolitan Medical Response System Working Group'' has the
meaning that term has in section 2136 of the Homeland Security
Act of 2002, as added by this section.
SEC. 302. ENHANCING LABORATORY BIOSECURITY.
(a) Federal Experts Security Advisory Panel.--
(1) Panel.--
(A) Establishment.--The President shall establish a
permanent advisory panel to be known as the Federal
Experts Security Advisory Panel to make technical and
substantive recommendations on biological agent and
toxin security.
(B) Membership.--The members of the Panel--
(i) shall consist of the voting members
appointed under subparagraph (D) and the
nonvoting members appointed under subparagraph
(E); and
(ii) except as provided in subparagraph (E),
shall each be an official or employee of the
Federal Government.
(C) Co-chairs.--The voting members of the Panel
appointed under clauses (i), (v), and (vi) of
subparagraph (D) shall serve jointly as the Co-Chairs
of the Panel.
(D) Voting members.--The voting members of the Panel
shall consist of 1 voting representative of each of the
following Government entities, appointed (except with
respect to the National Security Council) by the head
of the respective entity:
(i) The Department of Agriculture.
(ii) The Department of Commerce.
(iii) The Department of Defense.
(iv) The Department of Energy.
(v) The Department of Health and Human
Services.
(vi) The Department of Homeland Security.
(vii) The Department of Justice.
(viii) The Department of Labor.
(ix) The Department of State.
(x) The Department of Transportation.
(xi) The Department of Veterans Affairs.
(xii) The Environmental Protection Agency.
(xiii) The National Security Council, which
shall be represented by the Special Assistant
to the President for Biodefense.
(xiv) The Office of the Director of National
Intelligence.
(xv) Any other department or agency
designated by the Co-Chairs.
(E) Nonvoting members.--The nonvoting members of the
Panel shall consist of--
(i) such additional representatives of the
Government entities listed in subparagraph (D)
as may be appointed by the heads of the
respective entities; and
(ii) a representative of the public health
laboratory community or biological laboratory
community (or both).
(F) Administrative support.--The Secretary of Health
and Human Services shall provide to the Panel such
facilities, staff, and support services as may be
necessary for the Panel to carry out its
responsibilities under paragraph (2).
(2) Responsibilities.--Not later than 6 months after the date
of the enactment of this section, the Panel shall, with respect
to biological agent and toxin security, deliver to the
Secretaries of Agriculture, Health and Human Services, and
Homeland Security plurality recommendations, including any
statements of dissent, concerning--
(A) the designation as highest risk of that subset of
biological agents and toxins listed pursuant to section
351A(a)(1) of the Public Health Service Act (42 U.S.C.
262a(a)(1)) that presents the greatest risk of
deliberate misuse with significant potential for mass
casualties or devastating effects to the economy,
informed by--
(i) any biological or bioterrorism risk
assessments conducted by the Department of
Homeland Security and relevant assessments by
other agencies; and
(ii) determinations made by the Secretary of
Homeland Security pursuant to section 319F-
2(c)(2)(A) of such Act (42 U.S.C. 247d-
6b(c)(2)(A));
(B) the development of a set of minimum risk-based
prescriptive laboratory security performance standards
based on the risk at the lowest level, allowing for
enhancements as risk increases;
(C) the establishment of appropriate standards and
practices to improve vetting and monitoring of, and
ensure reliability of, personnel with access to highest
risk biological agents and toxins at facilities
registered under section 351A(d) of the Public Health
Service Act (42 U.S.C. 262a(d));
(D) the establishment of appropriate practices for
physical security and cyber security for facilities
that possess highest risk biological agents or toxins;
(E) standards for training of laboratory personnel in
security measures;
(F) other emerging policy issues relevant to the
security of biological agents and toxins;
(G) adequacy of information sharing protocols with
biodefense and biosecurity stakeholders; and
(H) any other security standards determined
necessary.
(b) Revision of Rules and Regulations.--
(1) Proposed rules.--The Secretaries of Health and Human
Services and Agriculture, in coordination with the Secretary of
Homeland Security, no later than 1 year after the date of
receipt of recommendations under subsection (a)(2), shall, as
appropriate, propose rules under section 351A of the Public
Health Service Act (42 U.S.C. 262a) establishing security
standards and procedures that are specific to highest risk
biological agents and toxins.
(2) Final rules.--The Secretaries of Health and Human
Services and Agriculture, in coordination with the Secretary of
Homeland Security, no later than 24 months after the date of
the enactment of this section, shall promulgate final rules
described in paragraph (1).
(c) Coordination of Federal Oversight.--To ensure that the Federal
Government provides for comprehensive and effective oversight of
biological agents and toxins security, the heads of the Government
entities listed in subsection (a)(1)(D) shall for facilities in which
the entity supports biological agent or toxin laboratory activities and
by no later than 6 months after the submission of recommendations under
subsection (a)(2), develop and implement a plan for the coordination of
biological agents and toxins security oversight that--
(1) articulates a mechanism for coordinated inspections of
and harmonized administrative practices for facilities
registered under section 351A(d) of the Public Health Service
Act (42 U.S.C. 262a(d)), pursuant to subsection (d) of this
section; and
(2) ensures consistent and timely identification and
resolution of biological agents and toxins security and
compliance issues.
(d) Common Inspection Procedures.--The heads of the entities listed
in subsection (a)(1)(D) shall coordinate or consolidate laboratory
inspections and ensure that such inspections are conducted using a
common set of inspection procedures across such entities in order to
minimize the administrative burden on such laboratory.
(e) Inspection Reports.--Any inspection report resulting from an
inspection described in paragraph (1) shall be available to--
(1) each Federal agency that supports biological agent or
toxin laboratory activities at the laboratory that is the
subject of the inspection report; and
(2) the laboratories that are the object of inspection.
(f) Laboratory Biosecurity Information Sharing.--
(1) Federal sharing.--The Secretaries of Health and Human
Services and Agriculture shall--
(A) develop a process for sharing of information
pertaining to biological agents and toxins with
agencies that support biological agent or toxin
laboratory activities, that identifies the purpose for
sharing, and a mechanism for securing, such
information;
(B) share relevant information pertaining to
biological agents and toxins, including identification
of laboratories possessing highest risk biological
agents and toxins, and compliance issues with the
Secretary of Homeland Security; and
(C) share relevant information pertaining to
biological agents and toxins, including identification
of laboratories possessing highest risk biological
agents and toxins, with appropriate State, local, and
tribal government authorities, including law
enforcement authorities and emergency response
providers.
(2) Classified and sensitive information.--The Secretaries of
Agriculture and Health and Human Services shall ensure that any
information disseminated under this section is handled
consistently with--
(A) 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. 401 et seq.) and related procedures or similar
authorities of the Attorney General concerning
sensitive law enforcement information;
(B) section 552a of title 5, United States Code
(commonly referred to as the ``Privacy Act of 1974'');
and
(C) other relevant laws.
(g) Definitions.--In this section:
(1) The terms ``biological agent'' and ``toxin'' refer to a
biological agent or toxin, respectively, listed pursuant to
section 351A(a)(1) of the Public Health Service Act (42 U.S.C.
262(a)(1)).
(2) The term ``highest risk'' means, with respect to a
biological agent or toxin, designated as highest risk as
described in subsection (a)(2)(A).
(3) The term ``Panel'' means the Federal Experts Security
Advisory Panel under subsection (a).
(4) The term ``State, local, and tribal'' has the same
meaning that term has in the Homeland Security Act of 2002 (6
U.S.C. 101 et seq.).
SEC. 303. DEFINITIONS.
Section 2 of the Homeland Security Act of 2002 (6 U.S.C. 101) is
amended by adding at the end the following new paragraphs:
``(19) The term `Intelligence Community' has the meaning
given that term in section 3(4) of the National Security Act of
1947 (50 U.S.C. 401a(4)).
``(20) The term `national biosecurity and biodefense
stakeholders' means officials from the Federal, State, local,
and tribal authorities and individuals from the private sector
who are involved in efforts to prevent, protect against,
respond to, and recover from a biological attack or other
biological incidents that may have serious health or economic
consequences for the United States, including wide-scale
fatalities or infectious disease outbreaks.''.
SEC. 304. DUAL-USE TERRORIST RISKS FROM SYNTHETIC BIOLOGY.
(a) Sense of Congress.--It is the sense of Congress that the field of
synthetic biology has the potential to facilitate enormous gains in
fundamental discovery, public health, and biotechnological
applications, but that it also presents inherent dual-use homeland
security risks that must be managed.
(b) Assessment of Risk.--Not less frequently than once every two
years, the Secretary of Homeland Security, acting through the Under
Secretary for Science and Technology, shall undertake a risk assessment
of the dual-use and other risks associated with synthetic biology.
(c) Establishment of Guidance.--Not later than six months after the
date of the enactment of this Act, the Secretary shall develop and
provide to the heads of all departments and agencies that fund life
sciences research, guidance on compliance with United States laws, arms
control agreements to which the United States is a party or signatory,
and individual department and agency policy, including consideration
of--
(1) best practices for establishing a department or agency
process that achieves compliance for department or agency
research, development, or acquisition projects in the life
sciences;
(2) the types of projects that should be assessed;
(3) at what stage or stages such projects should be assessed;
and
(4) means for preventing the release of homeland or national
security information.
(d) Research and Development.--Based upon the findings of the risk
assessment undertaken in accordance with subsection (b), the Under
Secretary may conduct research into the risks and ways to mitigate such
risks of synthetic biology, including--
(1) determining the current capability of synthetic nucleic
acid providers to effectively differentiate a legitimate
customer from a potential terrorist or other malicious actor;
(2) determining the current capability of synthetic nucleic
acid providers to effectively screen orders for sequences of
homeland security concern; and
(3) making recommendations regarding screening software,
protocols, and other remaining capability gaps uncovered by
such risk assessment.
SEC. 305. DISSEMINATION OF INFORMATION ANALYZED BY THE DEPARTMENT TO
STATE, LOCAL, TRIBAL, AND PRIVATE ENTITIES WITH
RESPONSIBILITIES RELATING TO HOMELAND SECURITY.
Section 201(d)(8) of the Homeland Security Act of 2002 (6 U.S.C.
121(d)(8)) is amended by striking ``and to agencies of State'' and all
that follows and inserting ``to State, local, tribal, and private
entities with such responsibilities, and, as appropriate, to the
public, in order to assist in preventing, deterring, or responding to
acts of terrorism against the United States.''.
TITLE IV--PUBLIC HEALTH MATTERS
SEC. 401. SENSE OF CONGRESS REGARDING FEDERAL COORDINATION ON MEDICAL
COUNTERMEASURES.
It is the sense of Congress that--
(1) 10 years after the terrorist attacks of September 11,
2001, and 7 years after enactment of the Project BioShield Act
of 2004 (Public Law 108-276), coordination among Federal
agencies involved in activities relating to researching,
developing, and acquiring medical countermeasures still needs
improvement; and
(2) aggressive action should be taken by the Department of
Health and Human Services (in particular, the heads of the
National Institutes of Health, the Biomedical Advanced Research
and Development Authority, the Centers for Disease Control and
Prevention, and the Food and Drug Administration), the
Department of Homeland Security, and the Department of Defense
to foster greater coordination with respect to such activities,
including adoption of an interagency agreement that sets forth
the relative areas of responsibility with respect to
establishing medical countermeasure requirements and
researching, developing, and acquiring medical countermeasures
to meet those requirements.
SEC. 402. NATIONAL MEDICAL COUNTERMEASURE DISPENSING STRATEGY.
Title III of the Public Health Service Act is amended by inserting
after section 319F-4 (42 U.S.C. 247d-6e) the following:
``SEC. 319F-5. NATIONAL MEDICAL COUNTERMEASURE DISPENSING STRATEGY.
``(a) Definitions.--In this section--
``(1) the term `dispense' means to provide medical
countermeasures to an affected population in response to a
threat or incident; and
``(2) the term `medical countermeasure' means a qualified
countermeasure (as defined in section 319F-1(a)(2)).
``(b) Strategy.--
``(1) In general.--The Secretary, in coordination with the
Secretary of Homeland Security, the Secretary of Agriculture,
and other appropriate Federal agencies, shall develop,
implement, and, as appropriate, periodically update a National
Medical Countermeasure Dispensing Strategy to enhance
preparedness and collective response to a terrorist attack on
humans or animals with any chemical, biological, radiological,
or nuclear material, that delineates Federal, State, and local
responsibilities.
``(2) Considerations.--The strategy shall be sufficiently
flexible to meet the unique needs of different communities,
including first responders, and shall consider--
``(A) a variety of options for dispensing medical
countermeasures, including to individuals, schools,
universities, hospitals, and elderly care facilities;
``(B) post-incident requirements for emergency use
authorizations before countermeasures can be
distributed legally;
``(C) the inclusion of locally held caches of
countermeasures in event-specific authorizations
covering federally held countermeasures of the same
type; and
``(D) distribution to the public of home medical kits
for personal stockpiling purposes, within 30 days after
a domestic or international bioterrorist attack
resulting in human infection.
``(c) Coordination.--The Secretary shall coordinate with the
Administrator of the Federal Emergency Management Agency, State, local,
and tribal authorities, representatives from the private sector, and
nongovernmental organizations on the National Medical Countermeasures
Dispensing Strategy.
``(d) Report.--Not later than 1 year after the date of the enactment
of this section, the Secretary shall submit the National Medical
Countermeasures Dispensing Strategy to the appropriate congressional
committees.''.
SEC. 403. NATIONAL PRE-EVENT VACCINATION AND ANTIMICROBIAL DISPENSING
POLICY REVIEW.
(a) Requirement.--The Secretary of Health and Human Services, in
coordination with the Secretary of Homeland Security and the Secretary
of Agriculture, shall review the adequacy of domestic vaccination and
antimicrobial dispensing policy, guidance, and information provided to
the public in light of any known terrorist risk of a biological attack
or other phenomena that may have serious health consequences for the
United States, including wide-scale fatalities or infectious disease
outbreaks including outbreaks associated with the avian flu. In
carrying out the review under this section, the Secretary shall
consider--
(1) terrorism risk assessments under section 2102 of the
Homeland Security Act of 2002, as amended by this Act, and
material threat assessments and determinations under the
Project Bioshield Act of 2004 (Public Law 108-276) and the
amendments made by that Act;
(2) reports on global trends and intelligence produced by the
Office of the Director of National Intelligence and the
Intelligence Community regarding biological threats;
(3) the availability of federally provided vaccines and
antimicrobials to dispense to first responders and the public,
on a voluntary basis, in anticipation of a biological attack;
(4) applicability of Federal shelf-life extension programs to
locally held stockpiles of medical countermeasures, to the
extent that information on local stockpiles is available;
(5) making expiring products available to appropriate
international organizations or foreign partners once the
requests of domestic stakeholders have been fulfilled;
(6) the implications of pre-event vaccination and
antimicrobial dispensing to livestock; and
(7) mechanisms to increase coordination between the Strategic
National Stockpile established under section 319F-2 of the
Public Health Service Act (42 U.S.C. 247D-6b) and the National
Veterinary Stockpile that would enhance vaccination and
dispensing capabilities.
(b) Report.--Not later than 1 year after the date of the enactment of
this Act, the Secretary of Health and Human Services shall report to
the appropriate congressional committees on the review required by
subsection (a), together with any recommendations relating to the
availability of domestic vaccine and antimicrobials for disbursing to
the public and voluntary immunization by first responders.
SEC. 404. MANAGEMENT OF SHORT SHELF LIFE VACCINE AND ANTIMICROBIAL
STOCKPILES.
The Secretary of Health and Human Services shall make available
surplus vaccines and antimicrobials, and vaccines and antimicrobials
with short shelf lives, from the strategic national stockpile under
section 319F-2(a) of the Public Health Service Act (42 U.S.C. 247d-
6b(a)) to State, local, and tribal first responders, including health
care responders, for administration to such responders who voluntarily
consent to such administration, and shall--
(1) establish any necessary logistical and tracking systems
to facilitate making such vaccines and antimicrobials so
available; and
(2) distribute disclosures regarding associated risks to end
users.
SEC. 405. MATERIAL THREAT DETERMINATIONS REVIEWS.
Section 319F-2(c)(2)(A) of the Public Health Service Act (42 U.S.C.
Sec 247d-6b(c)(2)(A)) is amended--
(1) in clause (i), by striking ``and'' at the end;
(2) by redesignating clause (ii) as clause (iii);
(3) by inserting after clause (i) the following:
``(ii) establish criteria for the issuance of
a material threat determination;'';
(4) in clause (iii), as so redesignated, by striking the
period at the end and inserting ``; and''; and
(5) by adding at the end the following:
``(iv) review and reassess determinations
under clause (iii) to determine whether agents
continue to present a material threat against
the United States population sufficient to
affect national security and homeland
security.''.
SEC. 406. BACKGROUND CHECKS.
Section 351A(e)(3)(A) of the Public Health Service Act (42 U.S.C.
262a(e)(3)(A)) is amended by adding at the end the following: ``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, the Secretary of Defense, and the
Secretary of State to determine whether these officials possess any
information relevant to the identification of such an individual by the
Attorney General.''.
SEC. 407. STATE, LOCAL, AND TRIBAL DEFINED.
In this title, the term ``State, local, and tribal'' has the same
meaning that term has in the Homeland Security Act of 2002 (6 U.S.C.
101 et seq.).
TITLE V--FOREIGN RELATIONS MATTERS
SEC. 501. INTERNATIONAL ENGAGEMENT TO ENHANCE BIODEFENSE AND LABORATORY
BIOSECURITY.
The Secretary of State, in consultation with the Special Assistant to
the President for Biodefense, and the heads of appropriate Federal
agencies, shall, as appropriate--
(1) support efforts of other countries to establish and build
capacity to effectively implement legislation criminalizing the
development or use of biological weapons or acts of
bioterrorism;
(2) engage other countries and international nongovernmental
entities to develop and establish common standards, guidance,
and best practices for actions relevant to preventing acts of
bioterrorism and the illicit use of life sciences;
(3) support the efforts of other countries to enhance
biosecurity and safety practices at laboratories and other
facilities with materials that could be used in biological
weapons or in an act of bioterrorism;
(4) promote the development and adoption of international
guidance for the safety and security of high-risk pathogens and
toxins; and
(5) promote information sharing relating to threats and best
practices between the intelligence community, Federal law
enforcement, and international law enforcement and security
officials.
SEC. 502. INTERNATIONAL COLLABORATION AND INFORMATION SHARING RELATING
TO BIOSECURITY.
The Secretary of State, in consultation with the Secretary of
Homeland Security, the Secretary of Agriculture, the Secretary of
Health and Human Services, and the heads of other appropriate Federal
agencies, shall, as appropriate--
(1) support efforts in other countries and regions to develop
mechanisms and capabilities for reporting to United Nations
organizations validated data on biological attacks or other
phenomena that may have serious health consequences for the
United States, including wide-scale fatalities or infectious
disease outbreaks;
(2) engage other Federal and nongovernmental entities and
other countries to advance awareness and understanding of the
risk posed by information derived from the life sciences that
has the potential for misuse to cause harm, and advance
recommendations on how best to address such risk;
(3) engage such entities and countries to promote greater
awareness and understanding of the global availability of and
access to life science technologies and materials; and
(4) promote the development and use of mechanisms for
reporting, preserving, and sharing data on Federal programs and
investments in international scientific, agricultural, medical,
and public health collaborations in support of efforts to
enhance global biosecurity.
SEC. 503. INTERAGENCY TASK FORCE ON BEST PRACTICES FOR GLOBAL
BIOPREPAREDNESS.
(a) Sense of Congress.--It is the sense of Congress that preparedness
for a chemical, biological, radiological, or nuclear incident must be
undertaken not only domestically but also internationally.
Specifically, there is a need for a global preparedness architecture
for such an event. Congress supports efforts to provide an
international forum for discussion of key health security policies with
international dimensions, and the establishment of a formal United
States interagency task force to develop best practices and
recommendations for implementation of a global preparedness
architecture could enhance global preparedness.
(b) Establishment of Task Force.--The Secretary of State shall
convene and lead an interagency task force to examine--
(1) the state of global biopreparedness for a major
biological event;
(2) necessary components of a global biopreparedness
architecture that would advance international health security,
including considerations of--
(A) risk assessments;
(B) prevention;
(C) protection;
(D) regional stockpiling of medical countermeasures,
including considerations of--
(i) security of the stockpile;
(ii) preservation of the stockpile through
effective detection and diagnosis, shelf life
extension programs, and other means;
(iii) delivery planning; and
(iv) legal considerations for implementing
such an architecture;
(E) response and attribution;
(F) other elements that should be a component of such
an architecture; and
(G) obstacles to implementing such an architecture;
(3) best practices for preparedness based on lessons learned
from domestic efforts to address the above issues, and that may
be applicable internationally;
(4) activities undertaken through the National Intelligence
Strategy for Countering Biological Threats developed under
section 202 and the International Health Regulations 2005, as
well as other activities deemed relevant by the task force; and
(5) the utility of working through existing international
forums as a mechanism for distributing this information to the
international community.
(c) Membership.--Members of the task force shall include
representatives from--
(1) the Department of Homeland Security;
(2) the Department of Health and Human Services, including
the Centers for Disease Control and Prevention;
(3) the Department of Agriculture;
(4) the Department of Defense;
(5) the Department of Justice;
(6) the Department of State;
(7) the Director of National Intelligence;
(8) other Federal departments and agencies, as determined
appropriate by the Secretary; and
(9) national biosecurity and biodefense stakeholder
community, including from the pharmaceutical and biotechnology
industries, and the diagnostic laboratory community, as
determined by the Secretary.
(d) Report.--Not later than 1 year after the date of the enactment of
this Act, the Secretary shall submit to the appropriate congressional
committees a report on the findings of the task force established under
this section.
SEC. 504. BIOLOGICAL AND TOXIN WEAPONS CONVENTION.
The Secretary of State shall--
(1) promote confidence in effective implementation of and
compliance with the Convention on the Prohibition of the
Development, Production and Stockpiling of Bacteriological
(Biological) and Toxin Weapons and on their Destruction
(commonly referred to as the ``Biological and Toxin Weapons
Convention'') by the States party to the Convention by
promoting transparency with respect to legitimate activities
and pursuing compliance diplomatically to address concerns;
(2) promote universal membership in the Convention;
(3) develop an action plan for increasing international
adherence to the Convention; and
(4) ensure that United States participation in Convention
meetings is broadly inclusive of representatives of relevant
Federal departments and agencies.
Purpose and Summary
H.R. 2356, the WMD Prevention and Preparedness Act of 2011,
was introduced by Representatives Bill Pascrell, Jr. (D-NJ) and
Peter T. King (R-NY) on June 24, 2011. The purpose of H.R. 2356
is to enhance homeland security by improving efforts to
prevent, protect against, respond to, and recover from attacks
with weapons of mass destruction, and for other purposes.
Background and Need for Legislation
Title 18 of the ``Implementing Recommendations of the 9/11
Commission Act of 2007'' authorized the establishment of a
bipartisan commission to study the threat posed by the
proliferation of weapons of mass destruction (WMD). Congress
directed the independent Commission for the Prevention of WMD
Proliferation and Terrorism (Commission) to assess current
activities related to WMD prevention and preparedness.
The Commission, led by former Senators Bob Graham (Chair)
and Jim Talent (Vice-Chair), was charged with: Assessing
Federal activities, initiatives, and programs to prevent WMD
proliferation and terrorism; and providing a clear and
comprehensive strategy and concrete recommendations to address
the WMD threat. Due to time constraints and also to the nature
of the threats that emerged through their research, the
Commission chose to focus its efforts on biological and nuclear
threats, the two WMD threats that they felt had the greatest
potential to kill the largest number of people within the
United States.
The Commission submitted a report entitled, ``World at
Risk: The Report of the Commission on the Prevention of Weapons
of Mass Destruction Proliferation and Terrorism'' to the
President and the Congress in December 2008. The Commission
concluded that: Unless the global community acts decisively and
urgently, a terrorist attack involving WMD will more likely
than not occur somewhere in the world by the end of 2013;
terrorists are more likely to obtain and use a biological
weapon than a nuclear weapon; and the United States government
needs to more aggressively limit the proliferation of
biological weapons and reduce the prospect of a biological
terrorist attack.
In October 2009, the Commission issued a progress report
entitled, ``The Clock is Ticking: A Progress Report on
America's Preparedness to Prevent Weapons of Mass Destruction
Proliferation and Terrorism'' to call attention to what the
Commission believed to be the lack of progress in implementing
its previous recommendations. Subsequently, in January 2010,
the Commission released a ``Prevention of WMD Proliferation and
Terrorism Report Card,'' which assessed the actions taken by
the United States to address the recommendations made in
``World at Risk.'' Most recently, in October 2011, the follow-
up to the Commission--known as The WMD Center--released its
``Bio-response Report Card,'' which detailed key areas still at
risk in biopreparedness three years after the Commission's
initial recommendations were made.
Commissioners Graham and Talent testified before the Full
Committee on Homeland Security on April 21, 2010. The former
Senators testified to their belief that a WMD terrorist attack
will occur somewhere in the world by 2013. They reiterated
their view that the Nation has not done enough to prevent and
prepare for a domestic biological attack. They also expressed
their concern about the fractured state of Congressional
jurisdiction over homeland security matters and their desire to
see jurisdiction for the Department of Homeland Security
consolidated in the Committee on Homeland Security in the House
of Representatives, and the Committee on Homeland Security and
Governmental Affairs in the Senate.
Enactment of H.R. 2356 is needed to better address the gaps
identified by the Commission and to better organize efforts by
the public and private sectors to prevent, protect against,
respond to, and recover from an attack involving WMD. This
legislation implements the Commission's recommendations by
requiring a comprehensive approach to preventing and preparing
for biological and other WMD attacks. The bill addresses the
range of actions necessary to counter the WMD threat as
identified through the Committee on Homeland Security's
oversight work and the recommendations of the Commission on the
Prevention of WMD Proliferation and Terrorism. The approach is
to include all aspects of the preparedness framework--
prevention, protection, response, and recovery--for chemical,
biological, radiological, and nuclear (CBRN) attacks and
incidents.
Hearings
The Committee has convened numerous hearings during the
110th, 111th, and 112th Conresses that have informed the
substance of this and prior legislations.
110th Congress
On September 18, 2007, the Committee on Homeland Security
held a hearing entitled ``Protecting the Protectors: Ensuring
the Health and Safety of our First Responders in the Wake of
Catastrophic Disasters.'' The Committee received testimony
from: Jon R. Krohmer, MD, Deputy Chief Medical Officer and
Principal Deputy Assistant Secretary, Office of Health Affairs,
Department of Homeland Security; John Howard, MD, Director,
National Institute for Occupational Health and Safety, Centers
for Disease Control and Prevention, Department of Health and
Human Services; Ms. Cynthia A. Bascetta, Director, Health Care,
Government Accountability Office; Philip J. Landrigan, MD, MSc,
Professor and Chairman, Department of Community and Preventive
Medicine, Mount Sinai School of Medicine; Deputy Chief Nicholas
Visconti, International Association of Fire Fighters; and Mike
D. McDaniel, PhD, Secretary, Department of Environmental
Quality, State of Louisiana.
On May 15, 2008, the Subcommittee on Intelligence,
Information Sharing, and Terrorism Risk Assessment held a
hearing entitled ``The Resilient Homeland: How DHS Intelligence
Should Empower America to Prepare for, Prevent, and Withstand
Terrorist Attacks.'' The Subcommittee received testimony from:
Stephen E. Flynn, PhD, Jeane J. Kirkpatrick Senior Fellow for
National Security Studies, Council on Foreign Relations; Mr.
Amos N. Guiora, Professor of Law, University of Utah; and Mr.
R.P. Eddy, Ergo Advisors.
On July 22, 2008, the Subcommittee on Emerging Threats,
Cybersecurity, and Science and Technology held a field hearing
in Providence, Rhode Island entitled, ``Emerging Biological
Threats and Public Health Preparedness: Getting Beyond Getting
Ready.'' The Subcommittee received testimony from: Jeffrey W.
Runge, MD, Chief Medical Officer and Assistant Secretary for
Health Affairs, Department of Homeland Security; RADM W. Craig
Vanderwagen, MD, Assistant Secretary for Preparedness and
Response, Department of Health and Human Services; Captain
Peter Boynton, Deputy Regional Principal Federal Official for
Pandemic Influenza and Federal Security Director, Bradley
International Airport (Connecticut), Transportation Security
Administration, Department of Homeland Security; Michael G.
Kurilla, MD, PhD, Director, Office of Biodefense Research
Affairs and Associate Director for Biodefense Product
Development, National Institute of Allergy and Infectious
Diseases, National Institutes of Health, Department of Health
and Human Services; Daniel M. Sosin, MD, MPH, Director,
Biosurveillance Coordination Unit, and Associate Director for
Science, Coordination Office for Terrorism Preparedness and
Emergency Response, Centers for Disease Control and Prevention,
Department of Health and Human Services; David Gifford, MD,
MPH, Director of Health, Department of Health, State of Rhode
Island; MG Robert T. Bray, Rhode Island Adjutant General,
Commanding General, Rhode Island National Guard, Director Rhode
Island Emergency Management Agency, and Homeland Security
Advisor, State of Rhode Island; Mr. Thomas J. Kilday, Jr.,
Homeland Security Program Manager, Rhode Island Emergency
Management Agency, State of Rhode Island; and Hon. Peter T.
Ginaitt, Director, Emergency Preparedness, Lifespan Hospital
Network.
111th Congress
On July 29, 2009, the Committee on Homeland Security held a
hearing entitled ``Beyond Readiness: An Examination of the
Current Status and Future Outlook of the National Response to
Pandemic Influenza.'' The Committee received testimony from:
Hon. Jane Holl Lute, Deputy Secretary, Department of Homeland
Security; Hon. William Corr, Deputy Secretary, Department of
Health and Human Services; Ms. Bernice Steinhardt, Director,
Strategy Issues, Government Accountability Office; Ms. Colleen
M. Kelley, National President, National Treasury Employees
Union; Mark B. Horton, MD, MSPH, Director, Department of Public
Health, State of California; Mr. Richard G. Muth, Executive
Director, Maryland Emergency Management Agency, State Emergency
Operations Center, State of Maryland; and Thomas A. Farley, MD,
MPH, Health Commissioner, New York City, State of New York.
On September 14, 2009, the Subcommittee on Emerging
Threats, Cybersecurity, and Science and Technology held a field
hearing in Brooklyn, New York entitled ``Status Report on
Federal and Local Efforts to Secure Radiological Sources.'' The
Subcommittee received testimony from: Mr. Craig Conklin,
Director, Sector Specific Agency Executive Management Office,
Office of Infrastructure Protection, Department of Homeland
Security; Mr. Kenneth Sheely, Associate Assistant Deputy
Administrator for Global Threat Reduction, National Nuclear
Security Administration, Department of Energy; Mr. Robert
Lewis, Director, Division of Materials Safety and State
Agreements, Nuclear Regulatory Commission; Captain Michael
Riggio, Counterterrorism Division, Police Department, City of
New York, State of New York; Mr. Gene Miskin, Director, Office
of Radiological Health, Department of Health and Mental
Hygiene, New York City, State of New York; Bonnie Arquilla, DO,
Director of Disaster Preparedness, State University of New York
Downstate Medical Center; and Mr. Gene Aloise, Director,
Natural Resources and Environment, Government Accountability
Office.
On October 27, 2009, the Subcommittee on Emerging Threats,
Cybersecurity, and Science and Technology held a hearing
entitled ``Real-Time Assessment of the Federal Response to
Pandemic Influenza.'' The Subcommittee received testimony from:
Alexander Garza, MD, Chief Medical Officer and Assistant
Secretary for Health Affairs, Department of Homeland Security;
Nicole Lurie, MD, Assistant Secretary for Preparedness and
Response, Department of Health and Human Services; Mr. Richard
Serino, Deputy Administrator, Federal Emergency Management
Agency, Department of Homeland Security; and Ms. Marcy Forman,
Director, Intellectual Property Rights Coordination Center,
Department of Homeland Security.
On April 21, 2010, the Full Committee held a hearing
entitled ``Viewpoints on Homeland Security: A Discussion with
the WMD Commissioners.'' The Committee received testimony from
former Senators Bob Graham and Jim Talent.
On June 15, 2010, the Subcommittee on Emerging Threats,
Cybersecurity, and Science and Technology held a legislative
hearing on H.R. 5498. The Subcommittee received testimony from
Sara (Sally) T. Beatrice, PhD, Assistant Commissioner, Public
Health Laboratory, Department of Health and Mental Hygiene,
City of New York; Randall S. Murch, PhD, Associate Director,
Research Program Development, National Capital Region, Virginia
Polytechnic Institute and State University; Robert P. Kadlec,
MD, Vice President, Global Public Sector, PRTM Management
Consulting; and Julie E. Fischer, PhD, Senior Associate, Global
Health Security Program, Henry L. Stimson Center.
112th Congress
On March 17, 2011, the Subcommittee on Emergency
Preparedness, Response, and Communications held a hearing
entitled ``Ensuring Effective Preparedness, Response, and
Recovery for Events Impacting Health Security.'' The
Subcommittee received testimony from Dr. Alexander G. Garza,
MD, MPH, Assistant Secretary for Health Affairs, Chief Medical
Officer, Department of Homeland Security. This hearing provided
Subcommittee Members with an opportunity to examine the
President's Fiscal Year 2012 budget request for OHA and OHA's
progress in developing its mission to provide for health
security, among other purposes.
On April 13, 2011, the Subcommittee on Emergency
Preparedness, Response, and Communications held a hearing
entitled, ``Taking Measure of Countermeasures (Part 1): A
Review of Government and Industry Efforts to Protect the
Homeland Through Accelerated Research, Development, and
Acquisition of Chemical, Biological, Radiological, and Nuclear
Medical Countermeasures.'' The Subcommittee received testimony
from Ms. Cynthia Bascetta, Managing Director, Health Care,
Government Accountability Office; Dr. Segaran P. Pillai, Chief
Medical and Science Advisor, Chemical and Biological Division,
Science and Technology Directorate, Department of Homeland
Security; Dr. Richard J. Hatchett, Chief Medical Officer and
Deputy Director, Strategic Sciences and Management, Department
of Health and Human Services; Dr. Gerald W. Parker, Deputy
Assistant to the Secretary of Defense, Chemical and Biological
Defense, Department of Defense; Ms. Phyllis Arthur, Senior
Director, Vaccines, Immunotherapeutics, and Diagnostics Policy,
Biotechnology Industry Organization; Mr. John M. Clerici,
Principal, Tiber Creek Partners LLC; and Dr. Daniel Fagbuyi,
Medical Director, Disaster Preparedness and Emergency
Management, Children's National Medical Center.
On May 12, 2011, the Subcommittee on Emergency
Preparedness, Response, and Communications convened a hearing
titled, ``Taking Measure of Countermeasures (Part 2): A Review
of Efforts to Protect the Homeland through Distribution and
Dispensing of CBRN Medical Countermeasures.'' The Subcommittee
received testimony from Dr. Alexander Garza, Assistant
Secretary for Health Affairs and Chief Medical Officer, Office
of Health Affairs, Department of Homeland Security; Rear
Admiral Ali Khan, Director, Office of Public Health
Preparedness and Response, Centers for Disease Control and
Prevention, Department of Health and Human Services; Mr. Mike
McHargue, Director of Emergency Operations, Division of
Emergency Medical Operations, Florida Department of Health; Mr.
David Starr, Director, Countermeasures Response Unit, New York
City Department of Health and Mental Hygiene; Chief Lawrence E.
Tan, Emergency Medical Services Division, New Castle County,
Delaware (testifying on behalf of the Emergency Services Sector
Coalition on Medical Countermeasures); and Dr. Jeffrey Levi,
Executive Director, Trust for America's Health. This hearing
provided Subcommittee Members with the opportunity to examine
various distribution and dispensing plans and efforts at the
Federal, State, local, and private sector levels, including an
assessment of the challenges faced in distributing and
dispensing countermeasures to large segments of the population.
On June 23, 2011, the Subcommittee on Cybersecurity,
Infrastructure Protection, and Security Technologies and the
Subcommittee on Emergency Preparedness, Response, and
Communications held a joint hearing, prior to introduction, on
this legislation. The Subcommittees received testimony from
Hon. William J. Pascrell, Jr. a Representative in Congress from
the 8th District of New Jersey; Senator Jim Talent, Vice
Chairman, The WMD Center; Dr. Robert P. Kadlec, Former Special
Assistant to the President for Biodefense; and Mr. Richard H.
Berdnik, Sheriff, Passaic County, New Jersey.
On July 26, 2011, the Subcommittee on Cybersecurity,
Infrastructure Protection, and Security Technologies held a
hearing entitled, ``The Last Line of Defense: Federal, State,
and Local Efforts to Prevent Nuclear and Radiological Terrorism
Within the United States.'' The hearing examined Federal,
State, and local efforts to implement the domestic portion of
the Global Nuclear Detection Architecture (GNDA), with a focus
on efforts to build capability in the interior of the U.S.
including through the Securing the Cities program. The
Subcommittee received testimony from Mr. Warren M. Stern,
Director, Domestic Nuclear Detection Office, Department of
Homeland Security; Mr. Carl Pavetto, Deputy Associate
Administrator, Office of Emergency Operations, National Nuclear
Security Administration, Department of Energy; Mr. Richard
Daddario, Deputy Commissioner for Counterterrorism, New York
City Police Department; Mr. Mark Perez, Homeland Security
Advisor, Florida Department of Law Enforcement; and Mr. David
C. Maurer, Director, Homeland Security and Justice Issues,
Government Accountability Office.
On April 17, 2012, the Subcommittee on Emergency
Preparedness, Response, and Communications held a third hearing
titled, ``Taking Measure of Countermeasures (Part 3):
Protecting the Protectors.'' The Subcommittee received
testimony from Dr. James D. Polk, Principal Deputy Assistant
Secretary, Office of Health Affairs, Department of Homeland
Security; Mr. Edward J. Gabriel, Principal Deputy Assistant
Secretary, Preparedness and Response, Department of Health and
Human Services; Chief Al H. Gillespie, President and Chairman
of the Board, International Association of Fire Chiefs; Mr.
Bruce Lockwood, Second Vice President, USA Council,
International Association of Emergency Managers; Sheriff Chris
Nocco, Pasco County Sheriff's Office, Pasco County, Florida;
and Mr. Manuel Peralta, Director of Safety and Health, National
Association of Letter Carriers. This hearing, the third in the
series on medical countermeasures, provided Subcommittee
Members with the opportunity to explore plans and strategies to
ensure that emergency response personnel are protected in the
event of such an attack, including through voluntary pre-event
vaccination.
The Subcommittee on Emergency Preparedness, Response, and
Communications and the Subcommittee on Cybersecurity,
Infrastructure Protection, and Security Technologies held a
joint hearing on May 9, 2012 entitled, ``First Responder
Technologies: Ensuring a Prioritized Approach for Homeland
Security Research and Development.'' The Subcommittees received
testimony from Dr. Robert Griffin, Director of First Responder
Programs, Science and Technology Directorate, Department of
Homeland Security; Ms. Mary H. Saunders, Director, Standards
Coordination Office, National Institute of Standards and
Technology; Chief Edward Kilduff, Chief of Department, New York
City Fire Department, New York City, New York; Ms. Annette
Doying, Director, Office of Emergency Management, Pasco County,
Florida; and Ms. Kiersten Todt Coon, President and CEO, Liberty
Group Ventures.
Committee Consideration
The Committee met on May 9, 2012, to consider H.R. 2356,
and ordered the measure to be reported to the House with a
favorable recommendation, amended, by voice vote. The Committee
took the following actions:
The Committee adopted H.R. 2356, as amended, by unanimous
consent.
The following amendments were offered:
An Amendment in the Nature of a Substitute offered by
Mr.King (#1); was AGREED TO by voice vote.
An amendment to the Amendment in the Nature of a Substitute
offered by Mr. Cuellar (#1A); was AGREED TO, by unanimous
consent.
Page 67, line 7, before ``To facilitate'' insert ``(a) In General.--
''.
Page 67, after line 18, insert a new paragraph entitled ``(b) Lessons
Learned for National Level Exercises.''
An amendment to the Amendment in the Nature of a Substitute
offered by Mr. McCaul (#1B); was AGREED TO, by unanimous
consent.
Amend section 303 ``Sec. 304. Dual-use Terrorist Risks from Synthetic
Biology.''
An amendment to the Amendment in the Nature of a Substitute
offered by Mr. McCaul (#1C); was AGREED TO, by unanimous
consent.
In section 2102, add at the end a new paragraph entitled ``(e)
Written Procedures.''
An amendment to the Amendment in the Nature of a Substitute
offered by Ms. Richardson (#1D); was AGREED TO, by unanimous
consent.
Page 31, after line 7, insert a new subparagraph ``(iii) be designed
to provide accurate, essential, and appropriate information and
instructions to children and other special needs populations within the
population directly affected by an incident;''
An amendment to the Amendment in the Nature of a Substitute
offered by Ms. Richardson (#1E); was AGREED TO, by unanimous
consent.
Page 31, strike ``and'' after the semicolon at line 21, strike the
period at line 24 and insert ``; and'', and after line 24 insert the
following:
``(iii) to educational and childcare
facilities, including daycare centers, grade
schools, universities, hospitals, and elderly
care facilities.
Page 83, line 26, before the semicolon insert ``, including to
individuals, schools, universities, hospitals, and elderly care
facilities''.
An amendment to the Amendment in the Nature of a Substitute
offered by Ms. Richardson (#1F); was AGREED TO, by unanimous
consent.
Page 54, line 24, insert before the semicolon at the end the
following: ``, including the procurement of home medical kits that are
approved pursuant to the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) Or the Public Health Service Act (42 U.S.C. 201 et
seq.), as applicable'.''.
An amendment to the Amendment in the Nature of a Substitute
offered by Ms. Hahn (#1G); was AGREED TO, by unanimous consent.
Page 85, line 7, after ``outbreaks'' insert ``including outbreaks
associated with the avian flu''.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the recorded
votes on the motion to report legislation and amendments
thereto.
No recorded votes were requested during consideration of
H.R.2356.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has held oversight
hearings and made findings that are reflected in this report.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
2356, the WMD Prevention and Preparedness Act of 2011, would
result in no new or increased budget authority, entitlement
authority, or tax expenditures or revenues.
Congressional Budget Office Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
June 7, 2012.
Hon. Peter T. King,
Chairman, Committee on Homeland Security,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 2356, the WMD
Prevention and Preparedness Act of 2012.
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.
H.R. 2356--WMD Prevention and Preparedness Act of 2012
Summary: CBO estimates that H.R. 2356 would authorize the
appropriation of $394 million over the 2013-2017 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 H.R. 2356 would cost $342 million
over the 2013-2017 period. The bill would not affect direct
spending or revenues; therefore, pay-as-you-go procedures do
not apply.
H.R. 2356 would impose intergovernmental and private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
by requiring public and private laboratories to comply with new
security standards. Because the number of entities affected,
the types of toxins and biologic agents covered, and the nature
of security measures required would depend on future regulatory
actions, CBO cannot estimate the costs of the mandates or
whether they would exceed the annual thresholds for
intergovernmental or private-sector mandates ($73 million and
$146 million in 2012, respectively, adjusted annually for
inflation).
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 2356 is shown in the following table.
The costs of this legislation fall within budget functions 150
(international affairs), 450 (community and regional
development), 550 (health), 750 (administration of justice),
and 800 (general government).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------
2013 2014 2015 2016 2017 2013-2017
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
FEMA Programs:
Authorization Level................................. 42 42 42 42 0 168
Estimated Outlays................................... 12 25 42 42 29 150
HHS Programs:
Estimated Authorization Level....................... 45 40 40 40 40 205
Estimated Outlays................................... 17 36 39 39 40 171
Other Programs:
Estimated Authorization Level....................... 7 5 3 3 3 21
Estimated Outlays................................... 7 5 3 3 3 21
Total Changes:
Estimated Authorization Level................... 94 87 85 85 43 394
Estimated Outlays............................... 36 66 84 84 72 342
----------------------------------------------------------------------------------------------------------------
Note: FEMA = Federal Emergency Management Agency; HHS = Department of Health and Human Services.
Basis of estimate: For this estimate, CBO assumes that the
bill will be enacted in 2012, that the necessary amounts will
be provided each year, and that spending will follow historical
patterns for similar activities.
H.R. 2356 would authorize the appropriation of $42 million
annually over the 2013-2016 period for the Federal Emergency
Management Agency (FEMA) in DHS to make grants to state, local,
and tribal governments to prepare for and respond to acts of
terrorism and natural or man-made disasters that result in
significant loss of life. CBO estimates that implementing this
grant program would cost $150 million over the 2013-2017 period
and an additional $18 million after 2017.
CBO estimates that implementing H.R. 2356 would require the
appropriation of $205 million over the 2013-2017 period for
activities to be conducted by HHS and its agencies. The bill
would direct HHS to establish and implement a strategy for
dispensing antidotes or other countermeasures to mitigate the
effects of a terrorist attack. H.R. 2356 also would require HHS
to review its vaccination and antimicrobial dispensing policy
and to make recommendations to improve that policy. Based on
information from the Centers for Disease Control and Prevention
and on costs for similar activities, CBO estimates that
implementing those requirements would cost $171 million over
the 2013-2017 period.
H.R. 2356 would require the Secretary of State to establish
an interagency task force that would evaluate and improve
global preparedness for a major biological attack and to report
its findings to the Congress. The bill also would authorize the
National Security Council to advise the President on biodefense
matters, including developing a national biodefense plan and
analyzing activities undertaken by the federal government to
combat biological attacks. In addition, H.R. 2356 would require
DHS to develop security plans and assessments and to prepare
reports relating to threats from weapons of mass destruction.
Based on the cost of similar programs, CBO estimates that it
would cost $21 million over the 2013-2017 period to carry out
those activities.
Pay-As-You-Go considerations: None.
Intergovernmental and private-sector impact: H.R. 2356
would require public and private laboratories to comply with
new security standards and procedures that are specific to
highest-risk biological agents and toxins. Those new standards
include personnel hiring and training practices, physical and
cyber security requirements, information sharing protocols, and
other security standards deemed necessary. The duty to comply
with the new standards would impose intergovernmental and
private-sector mandates as defined in UMRA. Because the number
of entities affected, the types of toxins and biologic agents
covered, and the nature of limits and security measures
required would depend on future regulatory actions, 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 ($73 million
and $146 million in 2012, respectively, adjusted annually for
inflation).
Grants and other forms of assistance authorized in the bill
would benefit agencies of state, local, and tribal governments,
including public institutions of higher education that prepare
for and respond to acts of terrorism, natural disasters, and
other man-made disasters.
Estimate prepared by: Federal Costs: Mark Grabowicz (DHS),
Stephanie Cameron (HHS), Daniel Hoople (FEMA), Sunita D'Monte
(Department of State); Matthew Pickford (National Security
Council); Impact on State, Local, and Tribal Governments: Lisa
Ramirez-Branum; Impact on the Private Sector: Michael Levine.
Estimate approved by: Theresa Gullo, Deputy Assistant
Director for Budget Analysis.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII of the Rules of the
House of Representatives, H.R. 2356 contains the following
general performance goals, and objectives, including outcome
related goals and objectives authorized.
The purpose of H.R. 2356 is to enhance homeland security by
improving efforts to prevent, protect against, respond to, and
recover from attacks with weapons of mass destruction (WMD),
and for other purposes. This bill addresses the range of
actions necessary to counter the WMD threat as identified
through the Committee on Homeland Security's oversight work and
the recommendations of the Commission on the Prevention of WMD
Proliferation and Terrorism in its report, ``World at Risk: The
Report of the Commission on the Prevention of Weapons of Mass
Destruction Proliferation and Terrorism.'' The bill addresses
all aspects of the preparedness framework--prevention,
protection, response, and recovery--for chemical, biological,
radiological, and nuclear (CBRN) attacks and incidents.
The objectives of H.R. 2356 are to:
Address the recommendations of the Commission for the
Prevention of WMD Proliferation and Terrorism as
described in its report, ``World at Risk'';
Provide for a strategic approach to the national
biodefense enterprise through high level planning,
leadership, and integrated budgeting;
Establish a national biosurveillance strategy to
increase awareness of the biological threat and
identify acts of bioterrorism;
Improve the capabilities of the United States to
collect, analyze, and disseminate WMD-related
intelligence;
Integrate national biosecurity and biodefense
stakeholders into the homeland security intelligence
and information sharing process;
Provide a strong basis for CBRN risk assessments to be
used in order to improve security while prioritizing
resources;
Ensure that the export enforcement activities of the
Federal government are coordinated;
Ensure that prevention goals are met through
activities including appropriate information sharing;
performance of CBRN terrorism risk assessments;
coordination of Federal export enforcement; proper
communication of threat information to state, local,
and Tribal authorities and to the public; and promoting
individual and community preparedness;
Ensure that protection goals are met through
activities including detection of biological attacks;
rapid biological threat identification at ports of
entry; evaluation of detection technology; and domestic
implementation of the Global Nuclear Detection
Architecture;
Ensure that response goals are met through activities
including promulgation of guidance for first
responders; development and dissemination of integrated
plume models; establishment of a program to assess and
validate first responder equipment; authorization of
appropriate payment for laboratory response services;
authorization of a bioforensics analysis center; and
authorization of the Metropolitan Medical Response
System Program;
Ensure that recovery goals are met through initiatives
including identification of gaps in recovery
capabilities; promulgation of guidance for recovery;
and exercising of recovery activities;
Strengthen security at laboratories that possess
biological agents considered material threats to the
nation;
Promote research that will help prevent the misuse of
synthetic biology, and promote the promulgation of
guidance for Federal agencies that conduct research
with dual use potential;
Provide the sense of Congress that coordination of
Federal research and development into medical
countermeasures requires improvement;
Require the development of a National Medical
Countermeasure Dispensing Strategy to improve rapid
response capabilities in the aftermath of a CBRN
incident, and similarly require a review of pre-event
vaccination and antimicrobial dispensing policies;
Require that surplus vaccines and antimicrobials, and
those with short shelf lives, be made available on a
voluntary basis to first responders;
Require regular review of the list of agents
considered material threats to the nation;
Require improved coordination among Federal agencies
on background checks for those individuals requesting
access to work with select agents;
Reduce the misuse of life sciences and enhance global
biosecurity through increased international
collaboration and information sharing;
Identify and communicate best practices for
preparedness based on lessons learned from United
States domestic efforts that may be useful
internationally;
Promote the Biological and Toxin Weapons Convention;
and
Leverage existing systems and frameworks to the
greatest extent possible to achieve the above goals;
and
Overall, improve interagency cooperation on addressing
CBRN risks.
Congressional Earmarks, Limited Tax Benefits, and Limited Tariff
Benefits
In compliance with rule XXI of the Rules of the House of
Representatives, this bill, as reported, contains no
congressional earmarks, limited tax benefits, or limited tariff
benefits as defined in clause 9(e), 9(f), or 9(g) of the rule
XXI.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Preemption Clarification
In compliance with section 423 of the Congressional Budget
Act of 1974, requiring the report of any Committee on a bill or
joint resolution to include a statement on the extent to which
the bill or joint resolution in intended to preempt State,
local, or Tribal law, the Committee finds that H.R. 2356 does
not preempt any State, local, or Tribal law.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Sec. 1. Short title; table of contents.
This section provides that the Act may be cited as the
``WMD Prevention and Preparedness Act of 2012.''
Sec. 2. Definitions.
This section defines the following terms: ``appropriate
congressional committees''; ``Intelligence Community''; and
``national biosecurity and biodefense stakeholders.''
Title I--A National Biodefense Enterprise
Sec. 101. Special Assistant for Biodefense.
Section 101 requires the President to assign a member of
the National Security Council to serve as the Special Assistant
to the President for Biodefense. The Special Assistant shall
serve as the principal advisor to the President regarding
coordination of Federal biodefense policy including prevention,
protection, response, and recovery from biological attacks or
other phenomena that may have serious health consequences for
the United States, including wide-scale fatalities or
infectious disease outbreaks. In so doing, the Special
Assistant shall identify gaps in the existing biodefense
posture, lead the development of a National Biodefense Plan,
National Biosurveillance Strategy, and microbial forensics
strategy, oversee with the Director of the Office of Management
and Budget a cross-cutting biodefense budget, and in general
conduct oversight of the implementation of Federal biodefense
activities.
The Committee is concerned that the President has not
designated an individual with sufficient authority and
singularity of mission for the substantial responsibility of
coordinating Federal biodefense activities. A position of the
kind described existed under both President William J. Clinton
and President George W. Bush, and was eliminated in the current
Administration. Although the Administration has designated a
``WMD Coordinator'' as required by the ``Implementing
Recommendations of the 9/11 Commission Act of 2007,'' (Pub. Law
111-53) this individual has engaged almost exclusively in
nuclear counterproliferation matters. Without a central point
of authority to coordinate the myriad departmental and
interagency Federal activities related to biodefense,
inefficiencies, redundancies, and gaps in resource allocation
across an estimated $6 billion annual enterprise are likely to
occur. The Committee intends for this individual to be vested
with the necessary authorities to ensure a truly strategic
Federal approach to biodefense.
Sec. 102. National Biodefense Plan.
Section 102 requires the Special Assistant to the President
for Biodefense to submit to the President a National Biodefense
Plan that integrates myriad existing plans and addresses
identified capability gaps. Specifically, the plan identifies
biological risks to the nation and capability gaps in
mitigating those risks, delineates needed defense activities,
coordinates existing strategic documents and plans, defines
intergovernmental roles, and provides planning guidance to
biodefense and biosecurity stakeholders.
A central tenet of the WMD Commission's report was that
United States policy and strategy have not kept pace with
growing risks. Other bodies have also criticized Federal
efforts at strategic planning, such as the National Biodefense
Science Board, which found weaknesses in the Federal approach
to medical countermeasure development. Of course, agency-
specific planning efforts have not always been sufficient,
either; correspondence between goals and investments must occur
at the agency level for any interagency effort to be completely
successful. The Committee believes that cross-agency planning
should be centralized, should have metrics that are assessed
regularly, and should be led by an individual endowed with the
necessary authority to see to it that budget decisions are
appropriate, and take corrective action when they are not. The
Committee recognizes that numerous documents are considered to
be targeted or broad biodefense strategies or implementation
plans, including, but not limited to, several Homeland Security
Presidential Directives; Presidential Policy Directives; the
``National Strategy for Pandemic Influenza'' and its
implementation plan; and, most recently, the ``National Health
Security Strategy'' and its implementation plan. Many of these
have elements that would direct preparedness and response for
biological events, but the Committee believes that a single
implementation plan dedicated to the biodefense enterprise--a
National framework that would organize and prioritize
biodefense investments based on risk--is still needed.
The Committee understands that the scope of such a plan
could be so extensive as to make it unfeasible to implement in
a useful way. As such, the Committee intends for the plan to
prioritize those efforts that will mitigate the variety of
biological risks in the most meaningful and cost-effective way.
This can be done by assessing and then addressing areas of most
urgent need in prevention, protection, response, and recovery,
including through use of Department of Homeland Security risk
assessments. It should also consider that some critical
infrastructure sectors are more vulnerable than others, and the
plan should leverage strengths of different agencies for
minimizing cross-sector vulnerabilities. The Committee also
encourages the planners to think innovatively and consider
alternative approaches to preparedness than have previously
been the paradigm, for instance, the narrow planning for a
given agent that has characterized some previous efforts. The
Committee also intends the plan to address food defense.
Sec. 103. National Biosurveillance Strategy.
Section 103 requires the Special Assistant to the President
for Biodefense to examine the current state of biosurveillance
and develop and maintain a national strategy for
biosurveillance. Importantly, this strategy shall include an
implementation plan to: Advance real-time situational
awareness; foster information sharing among stakeholders; and
enhance the capability of the Federal government to rapidly
identify, characterize, localize, and track a biological event
of National concern by integrating and analyzing data.
The National Academies of Science reported in 2009 that the
Department of Homeland Security and the Department of Health
and Human Services should enhance efforts to develop a national
system of situational awareness for biological threats. In
2010, the Government Accountability Office (GAO) reported that
the Nation still lacks an overall strategy to help guide
Federal agencies and their partners' efforts to build and
maintain an integrated National biosurveillance capability. As
the GAO points out, the ``National Strategy for Countering
Biological Threats'' and the ``National Health Security
Strategy'' direct further development of biosurveillance
strategies and plans to help support their broader biodefense
goals. The Committee intends for the National Biosurveillance
Strategy to build on these proposed goals and frameworks, and
to focus explicitly on how to meet the challenges associated
with sourcing good data and with information sharing. The
Committee is aware that many challenges are associated with the
acquisition and analysis of biosurveillance data sets, with the
sharing of the data between and among different professions,
and in dealing with relevant classified information. There are
also many opportunities, however, that may facilitate such a
system, such as the expansion of use of electronic health
records. Such a capability is critical, given that biological
events often cannot be prevented, but can be mitigated through
early detection. The Committee encourages the drafters to
consider aligning goals and activities to those of Presidential
Policy Directive 8 (PPD-8) and its follow-ons.
Inconsistency in the definition and interpretation of
``biosurveillance'' has complicated challenges associated with
implementation and coordination of efforts at the National
level. The Strategy must include a definition of
``biosurveillance'' so that efforts to meet the goals of the
Strategy are properly focused. Definitions should be
standardized with other National biosurveillance efforts.
Upon Committee filing of this report, the National Security
Staff released such a strategy. The strategy is consistent with
the Committee's intent to frame the purpose of a Nationally
integrated biosurveillance capability, to integrate it with
other relevant strategies, and to emphasize the need for
leveraging existing activities. Important components, however,
such as defining goals and milestones, and defining roles and
responsibilities, are lacking. The Committee is, therefore,
anxious to examine the implementation plan that is due to
follow in 120 days, which will hopefully address these and
other needed details. Such an implementation plan is
particularly important in light of the fact that the one
Federal effort toward integrating biosurveillance information--
the National Biosurveillance and Integration System--has not
achieved optimal performance and the nation remains without
this capability.
Sec. 104. Comprehensive cross-cutting biodefense budget
analysis.
Section 104 requires the Special Assistant to the President
for Biodefense, in coordination with the Director of the Office
of Management and Budget, to transmit to the appropriate
Congressional committees a comprehensive cross-cutting
biodefense budget analysis that delineates and integrates the
biodefense expenditure requests for all Departments and
agencies involved in Federal biodefense efforts. All agencies
that perform biodefense work shall submit their proposed budget
request to the Special Assistant 30 days in advance of their
formal submission to the Office of Management and Budget. The
budget analysis shall provide a detailed analysis identifying
appropriations, obligational authority, and outlays that
contribute to biodefense. The analysis will also include an
indication of how the Federal activities in the budget support
the activities outlined in the National Biodefense Plan.
The Office of Management and Budget neither assesses nor
directs all annual Federal biodefense expenditures in a cross-
cutting manner. In fact, estimates of total Federal dollars
spent are derived only from think tank analyses. In the absence
of such an integrated approach, funds will not be optimally
spent. The Committee intends that the Special Assistant to the
President for Biodefense, working with the Director of the
Office of Management and Budget, will be endowed with
sufficient authority to collect the necessary information from
all relevant Departments and agencies, and require
modifications to budget submissions as necessary, consistent
with the National Biodefense Plan.
Title II--Intelligence Matters
Sec. 201. National Intelligence Strategy for Countering the
Threat from Weapons of Mass Destruction.
Section 201 requires the Director of National Intelligence,
in consultation with the Secretary of Homeland Security and
other appropriate Federal agencies, to develop and implement a
National Intelligence Strategy for Countering the Threat from
Weapons of Mass Destruction to improve national capabilities to
collect, analyze, and disseminate intelligence related to WMD.
The strategy shall identify and address target capabilities
needed for successful WMD intelligence collection; include
methods for recruitment, training, and retention of individuals
with expertise in the collection, analysis, and dissemination
of intelligence related to different types of WMD; and include
methods for information sharing and collaboration with non-
Federal stakeholders. The strategy shall be accompanied by an
implementation plan.
The Congressionally-mandated Commission on the Prevention
of WMD Proliferation and Terrorism found insufficiencies in the
Intelligence Community's ability to undertake WMD collection
and analysis. The Committee recognizes that the Intelligence
Community addresses the WMD threat in various parts of the
National Intelligence Strategy but believes that the
establishment of a targeted national strategy for countering
this homeland security threat is necessary given that the
responses to this emerging threat are dissimilar from responses
to traditional threats. Accordingly, the Committee intends for
the strategy to take these differences into account and to
contain goals and objectives that are tailored to the unique
characteristics of the WMD threat. The Committee believes that
individuals with considerable knowledge of WMD may reside in
the United States government but outside of the Intelligence
Community. The Committee intends for the Intelligence Community
to reach out to these experts and, where appropriate, to ask
these experts to assist in the analysis of technical
information related to WMD.
Sec. 202. National Intelligence Strategy for Countering
Biological Threats.
Recognizing the unique nature of the biological threat,
Section 202 requires the Director of National Intelligence, in
consultation with the Secretary of Homeland Security, the
Special Assistant to the President for Biodefense, and the
heads of other agencies to develop and implement a National
Intelligence Strategy for Countering Biological Threats. The
strategy shall identify and address target capabilities needed
for successful intelligence collection on biological threats;
include a plan for establishing a cadre of collectors and
analysts in the Intelligence Community; include methods for
collaboration; and include a plan for ensuring the
prioritization and sustained commitment of personnel and
resources to address biological threats. The strategy shall be
accompanied by an implementation plan.
The bioweapons threat must remain among the highest
national intelligence priorities, according to the WMD
Commission. The Committee has, therefore, called out an
additional strategy for biological threats since it is this
threat that the Commission determined to be of the most
concern; this strategy may be separate from the strategy
outlined in Sec. 201, or an annex to it. The Committee intends
for this strategy to build on the National Intelligence
Strategy for Countering Biological Threats, as initially
produced in 2007 and to authorize the activities already in
place regarding the National Intelligence Strategy for
Countering Biological Threats. The Committee also intends for
the Director of National Intelligence to draw upon knowledge in
the National Counterproliferation Center, the National
Counterterrorism Center and other members of the Intelligence
Community, as appropriate.
Sec. 203. State, local, and tribal defined.
In this title, the term ``State, local, and tribal'' has
the same meaning that term has in the ``Homeland Security Act
of 2002.''
Title III--Homeland Security Matters
Sec. 301. Weapons of mass destruction prevention and
preparedness.
Amends the Homeland Security Act of 2002 (Pub. Law 107-417)
by adding at the end the following new title:
Title XXI--Weapons of Mass Destruction Prevention and Preparedness
Subtitle A--Prevention
Sec. 2101. Weapons of mass destruction intelligence and
information sharing.
Section 2101 requires the Department of Homeland Security
Office of Intelligence and Analysis (I&A) to support homeland-
security focused analysis of terrorist actors pertaining to
CBRN materials, global biological threats, public health and
food, agricultural, and veterinary issues. The Department is
required to leverage existing and emerging homeland security
capabilities, such as fusion centers, and share information
with State, local, and Tribal partners and other stakeholders.
Where appropriate, I&A shall coordinate with other relevant
Department components, others in the Intelligence Community,
and other Federal, State, local, and Tribal authorities,
including officials from high-threat areas, and enable such
entities to provide recommendations on optimal information
sharing mechanisms. The Secretary shall report annually to the
appropriate congressional committees on activities to counter
the threat from WMD conducted by all relevant entities within
the Department.
The Committee is aware that many agencies, including the
Department of Homeland Security, are engaged in CBRN
intelligence and information sharing activities. This provision
ensures that the Department has adequate and enduring expertise
in its intelligence division to analyze and disseminate CBRN
information, which may be highly technical, and provide value
within the Intelligence Community. The Committee believes that
this unit should work to the greatest extent possible with
other Department of Homeland Security components (operational
and intelligence), headquarters elements, others in the
Intelligence Community, and State, local, and Tribal
authorities in order to enhance the Department's counter-WMD
activities. State, local, and Tribal participation, in
particular, should include officials from high threat areas.
The effective and appropriate sharing of information with State
and local partners is paramount and remains a Committee
priority. The Committee does not intend for the activities
outlined by this section to duplicate those already conducted
by the National Counterterrorism Center, the Federal Bureau of
Investigation, or other members of the Intelligence Community.
The Committee believes that strict adherence to relevant
national intelligence strategies, including those authorized in
Sections 201 and 202 of this Act, will ensure clarity of
mission for each Federal entity engaged in WMD intelligence
activities.
Sec. 2102. Risk assessments.
Section 2102 requires the Secretary of Homeland Security,
acting through the Under Secretary for Science and Technology,
and in coordination with other appropriate Department of
Homeland Security components and Federal departments and
agencies, to produce and periodically update a terrorism risk
assessment for CBRN threats, as well as an integrated risk
assessment that assesses all of the above threats and ranks
them against one another according to their relative risk. Each
assessment shall include a description of the methodology used
to conduct it, and the Secretary shall convene an interagency
task force of subject matter experts to provide recommendations
as to the adequacy of the methodologies. Sensitivity analyses
shall also be conducted on each assessment, and each assessment
shall consider the risk from an evolving adversary. The
assessments shall be used to inform and guide Department of
Homeland Security material threat assessments and
determinations; allocation of research and development
resources; prioritization of medical countermeasure research,
development, acquisition, and distribution and other national
strategic biodefense research; tailored risk assessments and
risk mitigation studies; and other homeland security
activities. In developing the assessments, the Secretary shall
seek input from national biosecurity and biodefense
stakeholders. The assessments shall be shared in classified and
unclassified formats with Federal, State, local, and Tribal
officials with a need for the information. The Secretary shall
also establish written procedures for appropriate usage of the
assessments.
The Committee believes that risk assessments are critical
for the determination of the most appropriate responses for
investment of finite budget resources. Such assessments must be
used to inform Departmental priorities, investments, and
activities, as well as other governmental CBRN activities, such
as development of medical countermeasures. They are important
for understanding the comparative risks of each type of threat,
and therefore where to prioritize investments. The Committee is
aware that the Department undertakes terrorism risk assessments
of the type described on a two-year cycle, and intends to
provide further guidance on what those assessments should look
like and how they should be used. The National Academies of
Science has reviewed the Department's approach to risk
assessments, and has provided recommendations to the Department
for improvement, specifically with respect to the bioterrorism
risk assessments and the challenges with using standard
techniques to assess that risk. The Committee expects for all
of the risk assessments performed under this section to
continue to improve in their reliability and utility, and for
recommendations from the established task force to be taken
seriously. In light of findings from the GAO that the
Department's risk assessments lack written procedures for
usage, this section calls for the formalization of such
procedures.
Sec. 2103. National Export Enforcement Coordination.
Section 2103 establishes that the Department of Homeland
Security shall maintain a unit for national export enforcement
coordination that is managed by the Secretary and that
coordinates the export enforcement activities among the
Departments of Homeland Security, Agriculture, Commerce,
Defense, Energy, Justice, State, and the Treasury, the
Intelligence Community, and other Federal agencies.
The Committee supports the Administration's efforts to
create greater efficiencies in the export control community.
The Committee intends to authorize activities underway at the
Department of Homeland Security to create greater efficiencies
in the export control community. The Committee recognizes the
investigations that U.S. Immigration and Customs Enforcement
and other Federal law enforcement agencies conduct in this
regard, and believes that a network for such coordination will
increase efficiencies and better integrate law enforcement,
intelligence, and other related activities for export control.
The Committee also intends for these activities to be
undertaken with an understanding of the commerce and security-
related context in which counter-proliferation activities must
occur. The Committee does not intend to subsume counter-
proliferation activities conducted by the Intelligence
Community under the Department of Homeland Security.
Sec. 2104. Communication of threat information.
Section 2104 requires the Administrator of the Federal
Emergency Management Agency (FEMA), in consultation with State,
local, and Tribal governments and in coordination with other
agencies, to develop a communications plan for providing
information to the public related to preventing, preparing for,
responding to, and recovering from CBRN attacks. Specifically,
the Administrator shall develop and disseminate pre-scripted
messages and message templates to State, local, and Tribal
officials so that they can incorporate them into emergency
plans, and quickly disseminate critical information to the
public in anticipation of or in the immediate aftermath of an
attack. The Administrator shall incorporate such message
templates into exercises.
This section also directs the Secretary of Homeland
Security, in coordination with the Attorney General and heads
of appropriate Federal agencies, to: ensure that homeland
security information concerning terrorist threats is
disseminated to the general public within the United States, as
appropriate; and establish a process to optimize opportunities
for qualified heads of State, local, and Tribal governments to
obtain appropriate security clearances so that they may receive
classified threat information when appropriate. This section
requires the Secretary of Homeland Security to prepare
unclassified threat bulletins on CBRN threats. The Secretary
shall also provide guidance to State, local, and Tribal
authorities on why certain communities are identified as being
at heightened risk of exploitation, and on how to communicate
terrorism-related threats and risks to the public within their
jurisdiction.
The Committee intends for FEMA to take every opportunity to
appropriately inform the public about risks, threats, and
guidance for response to CBRN incidents. Sustained public
education campaigns to disseminate as much information as
possible in advance of a CBRN event are critical. This practice
will minimize the amount of work and information sharing that
must occur post-incident. Pre-scripted messages and templates
will allow State, local, and Tribal authorities to exercise
their own plans in advance for sharing information with the
public. Unclassified threat bulletins will ensure that the
public has sufficient knowledge of the nature of a CBRN attack
that has occurred, without compromising classified information
and ongoing investigations. Messaging that provides strong
guidance on the responsibility of individuals in the early
stages of an attack, and the most appropriate actions they
should take to help themselves and those around them, must be
part of this planning. The Integrated Public Alert and Warning
System (IPAWS) should be leveraged in these efforts. The
Committee recognizes that FEMA is already undertaking work in
this area, such as in its improvised nuclear device
communications planning, and expects this work to continue
under the guidance of this section, and to leverage the
increasing body of literature on effective risk communication.
The Committee recommends consultation with non-governmental
organizations that can represent the needs of the public,
including those with disabilities and access and functional
needs, in the development of appropriate messaging.
Sec. 2105. Individual and community preparedness for
chemical, biological, radiological, and nuclear attacks.
In order to enhance our ability to establish individual and
community preparedness Nation-wide for CBRN threats, Section
2105 requires the Secretary of Homeland Security, acting
through the Administrator of FEMA, to assist State, local, and
Tribal governments in improving and promoting individual and
community preparedness and collective response to terrorist
attacks by: Developing and disseminating guidance and
checklists of recommended actions for individual and community
prevention and preparedness efforts; compiling and
disseminating information on best practices; providing
information and training materials; and conducting individual
and community preparedness outreach efforts.
Preparedness is not solely a Federal responsibility.
States, localities, the private sector, and individuals must
participate to ensure adequate preparation for terrorist events
and disasters. Individuals and communities must understand in
advance those functions that they may have to manage for
themselves. Section 2105 requires FEMA to provide guidance to
ensure that all relevant parties have the information they need
to establish their own measures of preparedness. The Committee
is aware that FEMA has undertaken efforts to build a toolkit
that includes checklists, good practices, and outreach efforts
for government at all levels to engage the whole community in
all-hazards preparedness, including CBRN attacks. The Committee
also recognizes that FEMA is undertaking activities in
association with PPD-8 and the National Preparedness Goal that
are relevant to the directives in this section. The Committee
recommends that these efforts be coordinated and consolidated
in a way that clearly defines the roles and responsibilities of
individuals and communities, in the ``whole of community''
context, and contains all necessary guidelines, checklists,
training, and other tools for CBRN preparedness and response.
Subtitle B--Protection
Sec. 2121. Detection of biological attacks.
Section 2121 requires the Secretary of Homeland Security to
implement a biological detection capability. The Secretary,
through this program, shall deploy detectors to areas based on
risk to indicate the presence of biological agents, and provide
advanced planning tools, concepts of operation, training
exercises, and technical assistance to jurisdictions hosting
the program. This section also directs the Secretary to: Enter
into memoranda of agreement with other agencies to set forth
roles and responsibilities; establish criteria to determine
whether coverage is sufficient; implement an assay equivalency
program; and contract with participating laboratories for the
provision of laboratory services on a fee-for-service basis or
other similar basis. This section also requires that a host of
criteria are met before any new system is procured, including
performance of cost-benefit analyses and agreement with
localities on concepts of operations.
Enhancing the nation's capabilities for rapid response to
biological attacks was one of the top recommendations from the
WMD Commission. Because detection of a pending biological
attack is so difficult, rapid post-event detection is key.
While an early warning detection system is not the sole means
to detect a bioterror event, the Committee believes that the
nation should have an early detection capability so that
recognition of sick individuals in the aftermath of the attack
is not the only means of detection. The detection system called
for in this section could currently be met via the BioWatch
system, although the Committee is well aware that BioWatch has
not been without management and operational challenges.
Accordingly, the Committee notes that the early detection
mandates of this section could be met through other solutions
as threats and capabilities evolve over time. To the extent
that the current BioWatch program is utilized to meet this
mandate, information should be provided to participating
laboratories on specificity, sensitivity, and limitations of
the technology, as well as on the public health implications of
a positive result. A biodetection system should not be seen as
a replacement for surveillance via the health care system and
detection via astute physicians; advanced patient-side assays
under development will be a critical piece to early detection.
Biodetection cannot be the responsibility of a single
department or agency, and efforts must be made across
government to improve capabilities. Furthermore, the Department
of Homeland Security must work with its Federal partners to
ensure consensus on matters such as assay selection and
standards. The Committee also recognizes that the success of
the BioWatch program depends on effective interaction with host
State and local public health laboratories. Finally, any
efforts to improve detection technologies must be balanced with
cost, and to do this, a cost-benefit analysis is required. The
fiscal costs of developing a new system may be too great if no
or minimal increase in system sensitivity is achieved;
alternatively, if an increase in capability along with a
decrease in cost per data point can be accomplished, this might
be a good investment. Thorough analysis of the capabilities of
the existing system must be undertaken prior to obligation of
funds for a new system. The Committee intends for development,
procurement, and deployment of any such system to be carried
out in alignment with the goals and objectives of the National
Biodefense Plan outlined in Section 102 and the National
Biosurveillance Strategy outlined in Section 103.
Sec. 2122. Rapid biological threat detection and
identification at ports of entry.
Section 2122 requires the Secretary of Homeland Security,
acting through the Under Secretary for Science and Technology
and in consultation with relevant component heads, to assess
whether the development of technological screening capabilities
for biological agents, pandemic influenza, and other infectious
diseases to support entry and exit screening at ports of entry
should be undertaken. If the Under Secretary determines such a
capability would be of value, the Secretary is directed, to the
extent possible, to initiate the development of safe and
effective methods to rapidly screen incoming persons at ports
of entry.
When the 2009 H1N1 influenza pandemic originated in the
United Mexican States and crossed over the United States
border, it surprised U.S. officials who had expected that the
next pandemic would emanate from Asia. The border remained open
and thousands continued to cross every day with no system for
border officials to determine who was infected. That experience
demonstrated that international borders offer very little
protection from the spread of infectious disease due to the
inability to quickly and effectively screen travelers. This
section, therefore, requires the Department to determine if a
rapid screening capability could be deployed at ports of entry
for infectious diseases and could be operationally feasible and
useful in controlling the spread of disease or the trafficking
of biological weapons. If the Department believes that such
screening tools are necessary, the Committee intends for the
Science and Technology Directorate to develop these screening
capabilities.
Sec. 2123. Evaluating detection technology.
Section 2123 authorizes the Secretary of Homeland Security,
in coordination with the Director of the National Institute of
Standards and Technology, to establish a program for evaluation
of chemical and biological detector technologies for end users
such as first responders. The program would establish metrics
for the adoption of voluntary consensus standards; establish a
process for voluntary testing and evaluation of such
technology; and, with manufacturer permission, make available
the results of testing and evaluation.
The Committee intends for the Science and Technology
Directorate to focus resources on this type of testing and
evaluation as rigorously as possible to determine the value of
existing technologies and to inform the purchase of detection
technology. This program should be coordinated with the
activities of the System Assessment and Validation for
Emergency Responders (SAVER) program, and also with the
Stakeholder Panel on Agent Detection Assays and other standards
work. Test results may be disclosed to Federal agencies, State,
local and Tribal governments, and the private sector with
permission of the manufacturer.
Sec. 2124. Domestic implementation of the Global Nuclear
Detection Architecture.
Section 2124 requires the Director of the Domestic Nuclear
Detection Office (DNDO) to establish and maintain a multi-
layered system of detection technologies and programs to
enhance the Nation's ability to interdict a radiological or
nuclear device in high-risk cities. This section also requires
the Director to develop a surge capability for radiological and
nuclear detection systems that can be rapidly deployed in
response to actionable intelligence. The programs described
above shall be integrated into the Global Nuclear Detection
Architecture.
This section authorizes the Securing the Cities (STC)
program to detect and prevent a radiological or nuclear attack
in high-risk United States cities. The detonation of an
improvised nuclear device or a radiological dispersal device in
a metropolitan area of the United States would have devastating
consequences due to loss of life, destruction of property, and
economic repercussions that ripple across the nation. STC is
the only DHS program dedicated specifically to reducing the
risk of radiological and nuclear terrorism through targeted
detection. STC has fostered unprecedented collaboration and
coordination among its many Federal, State, and local partners.
The Committee finds that STC has substantially increased
preventive radiological and nuclear detection awareness and
capabilities in the New York City metropolitan areaarea and is
an effective strategy for addressing the domestic layer of the
Global Nuclear Detection Architecture. The Committee commends
DNDO for its development and oversight of this unified
strategy. The Committee believes the experience in New York
City should be used as a template for expanding the program to
other high-risk cities that participate in the Urban Area
Security Initiative. Building on the program's record of
success, DNDO is highly encouraged to develop a cost-effective
plan for expansion of STC to additional cities and encompass a
broader range of WMD threats.
The Director of DNDO is also instructed to focus efforts on
coordinating the development of surge capabilities for
radiological and nuclear detection systems that can be deployed
within the United States rapidly in response to intelligence or
warnings. This includes support to State and local entities
with equipment, training and exercises. The Committee believes
the combination of both fixed and agile detection components
into a flexible architecture is the most cost-effective, risk-
based strategy for the domestic prevention of radiological and
nuclear terrorism. DNDO is strongly encouraged to address gaps
in the detection of shielded highly enriched uranium as it
develops and deploys these new surge capabilities.
Subtitle C--Response
Sec. 2131. First responder guidance concerning chemical,
biological, radiological, and nuclear attacks.
Section 2131 requires the Secretary of Homeland Security,
in coordination with the Secretary of Health and Human
Services, the Secretary of Agriculture, the Administrator of
the Environmental Protection Agency, the Attorney General, and
the heads of other Federal departments and agencies, to develop
voluntary, risk-based guidance for emergency and public health
personnel for responding to an explosion or release of CBRN
material. This guidance shall contain components such as
protective actions for ensuring the security, health, and
safety of emergency response providers and their families and
household contacts, and best practices for emergency response
providers to effectively diagnose, handle, and otherwise manage
individuals affected by an incident involving such an agent.
The Secretary shall enable the first responder and first
provider community to submit recommendations for areas for
which guidance could be developed.
Stakeholders have advised the Committee that current
guidance is disparate and can be difficult to follow. The
Committee believes it is necessary that a resource be developed
to serve as a comprehensive emergency response standard, which
addresses the full range of hazards or concerns currently
facing emergency responders. The Committee intends that the
Department will standardize a process that will involve
appropriate individuals from the emergency responder
communities to participate in the reviews and provide material
that is quickly accessible and easily updated. The Committee
hopes that the inclusion of the community in the process will
result in universal guidance of considerable utility. The
Committee intends that the Department will review relevant
existing Federal, non-Federal, international, academic, and
non-governmental materials when developing the guidance.
Guidance promulgated under this section should be integrated
into curricula for first responder training provided by the
Center for Domestic Preparedness and other such accredited
facilities to enhance WMD capabilities among our nation's first
responders.
The Committee recognizes the importance of aligning
response throughout the chain of leadership in the event of a
WMD attack or incident. The Committee expects the Department to
work closely with other Executive departments and agencies,
such as the Department of Labor, the Department of Health and
Human Services, and the Environmental Protection Agency, on the
development and dissemination of this guidance. The Committee
recognizes that reaching ``perfect'' standards may be
impossible. The Committee expects, however, that the Department
will leverage existing standards and integrate those standards
using the best available science to provide better guidance and
a framework that enhances response capability and safety to the
greatest extent possible in an area of considerable risk.
Sec. 2132. Integrated plume modeling for collective response.
Section 2132 requires the Secretary of Homeland Security to
develop and disseminate integrated plume models to enable rapid
response activities following a CBRN release. The Secretary
shall identify Federal, State, and local needs regarding plume
models; establish mechanisms for dissemination of these models
to enable appropriate collective response activities; and
ensure that guidance and training for the use of such models
are provided.
Plume models help first responders predict locations to
where a CBRN agent might disperse, allowing for forward
deployment of resources and the potential to save many lives.
The Committee believes plume models must be integrated with
protective action guidelines and other appropriate information
so they present a comprehensive picture to guide optimal
response to a CBRN event. The Committee recognizes the
considerable work already underway for plume modeling for
assisting government at all levels, including FEMA's work with
national laboratories and academia to support local government
planning needs. The Committee also recognizes that agencies
other than the Department of Homeland Security (such as the
Department of Energy and the Department of Defense) have
produced many plume models for a variety of theoretical and
real-world events. The Committee does not intend for the
Department of Homeland Security to duplicate this work.
Instead, the Committee intends for the Department to acquire
plume models from these agencies, work with them to integrate
protective action guidelines and other appropriate information,
and subsequently use and disseminate them.
Sec. 2133. Establishment of the system assessment and
validation for emergencyresponders (SAVER) program.
Section 2133 directs the Secretary of Homeland Security to
assess and validate commercial emergency responder equipment
and systems (including hand-held detectors for CBRN agents),
provide results to the emergency response provider community in
an operationally useful form, provide information about
equipment on the departmental authorized equipment list, enable
decision-makers and responders to better select, procure, use,
and maintain emergency responder equipment, and share this
information nationally with the emergency response provider
community.
This section authorizes ongoing activity within the Science
and Technology Directorate. The Committee is concerned that
some equipment and systems that are commercially available for
first responders have not been operationally tested, and
manufacturer claims may provide insufficient information to
assure that the equipment will perform reliably in the field.
The Committee supports the System Assessment and Validation for
Emergency Responders (SAVER) program because it objectively
validates the reliability of these systems and equipment and
provides first responders with information necessary for better
purchasing decisions. The Committee urges the SAVER program to
consult with the Federal Bureau of Investigation and other
Federal agencies that have conducted evaluations of such
equipment and systems for other purposes for their relevant
input, and intends that SAVER will undertake coordination with
other Federal efforts to develop minimum standards of
detection. The Committee also intends that the SAVER Program be
supported by the Stakeholder Panel on Agent Detection Assays
program.
Sec. 2134. Payment for laboratory response services.
Section 2134 authorizes the Secretary of Homeland Security,
the Attorney General, and other participating Federal agencies
to contract with State and local public health laboratories
that are members of the Laboratory Response Network (LRN) for
Biological Terrorism and other laboratories for the provision
of laboratory testing services on a fee-for-service basis or on
a prepayment or other similar basis. The Centers for Disease
Control and Prevention (CDC) will be informed by the agencies
of such contracts before such time that the contracts are
signed.
The Committee recognizes the important work of the
participating laboratories in the LRN. The Committee also
recognizes that the vast amount of initial laboratory testing
of suspicious powders and other materials is conducted by State
and local public health member laboratories. Additionally, the
Committee understands that at least one Federal agency has made
an unsuccessful attempt to transfer funds to the Department of
Health and Human Services for support of LRN laboratories. The
Committee intends for the provision to allow Federal agencies
participating in the LRN to be able to contract directly with
State and local LRN laboratories to pay for laboratory testing
services on a fee-for-service or similar basis, without going
through other Federal agencies. The Committee does not intend
for such payment for LRN services to supplant or replace other
funding that State and local public health laboratories receive
from other sources, including those from the Department of
Health and Human Services. The Committee intends for the
Federal agencies that utilize the laboratories to ensure that
these contracts are standardized and do not cause interference
among other contracts. Furthermore, it is the intent of the
language that requires informing of the CDC of outside
contracts to allow the CDC to assess whether such contracts
would impact the LRN laboratory's primary mission of responding
to public health emergencies.
Sec. 2135. Bioforensics capabilities.
Section 2135 authorizes a bioforensics analysis center in
the Department of Homeland Security that provides law
enforcement and intelligence-related investigations with
forensic examination of biothreat agents and related evidence.
The center will require that other Executive Branch agencies
reimburse it for services, rather than rely on Congressional
appropriations.
The Committee supports funding a strong bioforensics
capability that enables law enforcement to investigate and
attribute attacks and respond appropriately. Such analysis is
intended to support the executive agencies responsible for
preventing, deterring, responding to, attributing and
recovering from biological attacks. This mandate could be met
by the National Bioforensics and Analysis Center (NBFAC).
Section 2135 requires that executive agencies pay for the
forensic analysis and capability, exclusive of overhead, rather
than having the Department bear all of the costs. The Committee
expects that the implementation of a user fee-based system will
cover the costs of running casework and foster greater
oversight by the agencies that are NFBAC customers. A detailee
program is also authorized for the purposes of training and
information sharing.
Sec. 2136. Metropolitan Medical Response System Program.
Section 2136 requires the Secretary of Homeland Security to
conduct a Metropolitan Medical Response System Program (MMRS)
to assist State and local governments in preparing for and
responding to public health and mass casualty incidents
resulting from acts of terrorism, natural disasters, and other
man-made disasters. The Secretary of Homeland Security is
authorized to provide grants through the Administrator of FEMA
to State, local, and Tribal governments to strengthen medical
surge capacity; strengthen mass prophylaxis capabilities;
enhance detection capabilities; develop mass triage plans;
support information sharing and collaboration; conduct training
and exercises; and strengthen decontamination capabilities.
Jurisdictions that received funding in Fiscal Year 2009 are
eligible for continued funding. After Fiscal Year 2012, a
jurisdiction shall not be eligible unless the Secretary
determines that the jurisdiction maintains a sufficient
measured degree of capability in accordance with outlined
performance measures. The provision also requires a review of
the program to provide recommendations going forward. For each
of fiscal years 2012 through 2016, $42 million is authorized.
Section 301(d) requires a review of the program to provide
recommendations going forward.
The Committee believes that MMRS is an important grant
program for the first responder community. Authorizing it at
appropriate levels will ensure that it remains a stand-alone
program with dedicated funding, thereby providing localities
with the resources they require to meet critical medical
preparedness needs. Activities for which MMRS provides
resources include response training, equipment purchases,
dispensing of medical countermeasures, and overall coordination
for catastrophic incident response. These activities are
resource intensive and require continual equipment maintenance,
exercises, and other resources. The Committee believes that
continued support of homeland security grant programs is
necessary to ensure that State and local governments build and
sustain necessary capabilities to prevent, prepare for, respond
to, and recover from terrorist attacks.
Subtitle D--Recovery
Sec. 2141. Identifying and addressing gaps in recovery
capabilities.
Section 2141 requires the Secretary of Homeland Security,
acting through the Under Secretary for Science and Technology
and in coordination with the Administrator of the Environmental
Protection Agency, to conduct risk assessments to inform
prioritization of recovery activities for CBRN incidents. The
results of the assessments shall inform Federal efforts to
address the capability gaps uncovered by each assessment.
The ability to recover from a CBRN event is as critical as
other activities, such as response. If we cannot resume
commerce and provide a safe and secure environment for living,
basic standards of living grind to a halt. The Committee
believes that insufficient attention has been paid to recovery.
The Committee intends that these risk assessments be conducted
in coordination with the heads of appropriate departments and
agencies, such as the Department of Health and Human Services
and the Environmental Protection Agency. The results shall
inform recovery research and the development of recovery
guidelines by the Environmental Protection Agency.
Sec. 2142. Recovery from a chemical, biological,
radiological, and nuclear attack or incident.
Section 2142 requires the Secretary of Homeland Security,
in coordination and consultation with the heads of several
agencies, to develop and issue guidance for clean-up and
restoration of indoor and outdoor areas that have been affected
by a CBRN attack or incident. The guidance shall clarify
Federal roles and responsibilities for assisting State, local,
and Tribal authorities, and shall include risk-based
recommendations for matters such as standards for effective
decontamination and means for developing health and safety
plans to address first responder health risks. In carrying out
the guidance development, existing guidance shall be
inventoried, and the public shall be invited to submit
recommendations. The guidance should be prioritized based on
the risk assessments performed pursuant to section 2141.
The bill authorizes this existing activity and adds
additional requirements to address clean-up and restoration of
internal areas, such as subways; produce a decision framework
for local officials to determine how much of an organism
growing in specimens taken from places that have been cleaned
is acceptable; establish effective clean-up standards; and
establish standards for safe occupancy of affected sites. The
guidance should be straightforward and sufficiently detailed to
help local officials restore their communities and ensure that
affected areas are appropriately sampled, assessed,
characterized, and cleaned. The guidance developed under this
section should be consistent with existing and planned efforts
in other Federal departments and agencies, such as
decontamination and disposal requirements being developed by
the Department of Agriculture, and interagency work on the
National Disaster Recovery Framework. Important kinds of
technologies that would aid in recovery efforts, such as those
for rapid and effective decontamination, should be considered
for FEMA's Authorized Equipment List and cross-referenced in
the guidance. The Committee recognizes that the Department of
Homeland Security is not the sole Federal authority in
recovery, but views it as the best-suited agency to coordinate
the efforts of many agencies in developing much needed
guidance. The Department should, through this process, help to
clarify roles and responsibilities among Federal departments
and agencies, as well as State responsibilities. The guidance
should be consistent with existing and planned efforts.
Sec. 2143. Exercises.
Section 2143 requires the Secretary of Homeland Security to
develop exercises in consultation with State, local, and Tribal
authorities to facilitate recovery from a CBRN attack or
incident. The Secretary shall provide, to the maximum extent
practicable, lessons learned reports to those governments and
other entities that participate in the exercises. The goal of
this section is to ensure that the guidance developed and
promulgated under Section 2142 is sufficiently exercised by
State and local stakeholders. Exercises may be conducted in
coordination with the National Exercise Program.
Sec. 301(c) Conforming amendment.
Section 301(c) repeals Section 316 of the Homeland Security
Act of 2002, which established within the Department of
Homeland Security a National Biosurveillance and Integration
Center (NBIC). Section 301 instead requires the Special
Assistant to the President for Biodefense to publish a National
Biosurveillance Strategy, which shall include a plan for
enhancing the capability of the Federal government to rapidly
identify, characterize, localize, and track a biological event
of National concern.
The Implementing Recommendations of the 9/11 Commission Act
of 2007 (Pub. Law 107-53) required the Secretary of Homeland
Security to establish and operate the NBIC to rapidly identify
and track a biological event of national concern. While a
variety of systems exist at the Federal, State, and local
levels to retrieve some of this information, none actually
integrates all of the data from all sectors--human, animal,
plant, food, and the environment. This lack of integration has
prevented the Federal government from quickly discovering an
agent that might hit two sectors at once, or that is detected
in two states which use different databases.
Unfortunately, the Department has been unable to achieve
its mandate. While reasons for this shortcoming have included
technological difficulties and poor management, the Committee
believes that the most important failing has been refusal by
other agencies to share their data in the absence of a
perceived incentive to do so. Lacking sufficient data sharing,
the approximate $7 million annual cost of the program is wasted
taxpayer dollars. The Committee recognizes that the National
Security Staff are currently working on a new strategy for
biosurveillance, but is concerned at its significant delay. The
Committee looks forward to receiving this plan, and hopes that
it harnesses the authority of the President to require the
dozen agencies with this kind of data to share the needed
information. Although the Department of Homeland Security must
play a coordinating role, it has not succeeded in being the
prime integrator, and a new approach is necessary.
Sec. 302. Enhancing laboratory biosecurity.
Section 302 requires the President to establish a permanent
advisory panel, to be known as the Federal Experts Security
Advisory Panel (FESAP), to make recommendations on biological
agent and toxin security. The panel is comprised of voting
members from more than a dozen agencies, and is co-chaired by a
representative from the Department of Agriculture, the
Department of Health and Human Services, and the Department of
Homeland Security. A member of the laboratory community shall
also retain a seat as a nonvoting member. The panel shall
deliver recommendations on the highest risk biological agents
and toxins that the panel deems to present the greatest risk of
deliberate misuse; the development of a set of minimum risk-
based laboratory security performance standards; establishment
of standards to ensure reliability of personnel with access to
the highest risk pathogens; and establishment of physical,
cybersecurity, and other necessary security standards. The
Secretaries of Agriculture and Health and Human Services shall
issue proposed and final rules, as appropriate, based on the
panel recommendations. This section further requires that
Federal oversight over biological laboratories be coordinated,
including with respect to inspections. Finally, this section
requires sharing, as appropriate, of information with State,
local, and Tribal authorities pertaining to laboratories
possessing the highest risk agents.
The Committee acknowledges the work of the FESAP, which was
initiated after calls from the Congress and the WMD Commission
for closer attention to laboratory biosecurity. This section
codifies the FESAP and ensures that the Department of Homeland
Security plays a major role in the panel's decision-making
processes. The Secretary of Homeland Security is designated as
one of three recipients of the FESAP recommendations to ensure
full situational awareness. The establishment of personnel
reliability standards outlined should include a thorough
evaluation of existing vetting practices, should be approached
from a cost-benefit perspective, and should not impose
processes that would impose unsupportable burdens at the local
or laboratory level. The Committee intends that the proposed
rules will include guidance and tools to help laboratories with
implementation. Information sharing activities, particularly
with State, local, and Tribal partners, are proscribed because
the Committee believes that it is important for these
authorities to participate fully in the homeland security
mission, and that in order to do so, these authorities must be
empowered with knowledge.
Sec. 303. Definitions.
Section 303 amends the Homeland Security Act of 2002 to
include definitions of the terms ``Intelligence Community'' and
``national biosecurity and biodefense stakeholders.''
Sec. 304. Dual-use terrorist risks from synthetic biology.
Section 304 expresses the sense of Congress that the field
of synthetic biology has the potential to facilitate enormous
gains in fundamental discovery, but that its inherent dual-use
risks must be managed. Not less frequently than once every two
years, the Secretary of Homeland Security, acting through the
Under Secretary of Science and Technology, is required to
undertake a risk assessment of the dual-use and other risks
associated with synthetic biology. The Secretary of Homeland
Security is also required to promulgate guidance to other
departments and agencies on best practices for assuring
compliance with laws and treaties that govern biodefense
research. This section also authorizes the Under Secretary for
Science and Technology to conduct research into ways to
mitigate the dual-use threat.
The Committee intends for the Department of Homeland
Security to ascertain whether companies that produce and sell
synthesized DNA have the ability to support legitimate
researchers while screening out and preventing bad actors from
obtaining these materials. Because the field progresses so
rapidly, the provision requires regular assessment of the risks
to provide policymakers opportunities for decision making into
ways to mitigate the risks and prioritize budgets
appropriately. Understanding that it is challenging to
undertake a quantitative risk assessment of synthetic biology,
the assessment should at least attempt to utilize well-
established methodologies wherein risk is considered as a
function of threat, vulnerability, and consequences. With
respect to promulgation of guidance by the Department of
Homeland Security, the Department has a robust compliance
division for this purpose, and adherence by other agencies to
similar procedures could prevent unintentional breaches of
statute, international agreement, or sensitive information.
Sec. 305. Dissemination of information analyzed by the
Department to State, local, Tribal, and private entities with
responsibilities relating to homeland security.
Section 305 expands the list of entities in section
201(d)(8) of the Homeland Security Act of 2002 to which the
Department disseminates information to include State, local,
Tribal, and private sector entities with homeland security
responsibilities, and as appropriate, to the public, in order
to assist in preventing, deterring, or responding to acts of
terrorism against the United States. Specifically, this
provision adds Tribal entities and the public to the existing
provision, recognizing that they are important stakeholders and
partners in these efforts.
Title IV--Public Health Matters
Sec. 401. Sense of Congress regarding Federal coordination on
medical countermeasures.
Section 401 expresses the sense of Congress that
coordination among Federal agencies involved in research,
development, and acquisition of medical countermeasures
requires improvement, and that aggressive action should be
taken by the Department of Health and Human Services, the
Department of Homeland Security, and the Department of Defense
to foster improved coordination of such activities, including
adoption of an interagency agreement that sets forth relative
areas of responsibility.
The development of medical countermeasures to prevent and
treat the effects of CBRN agents has progressed significantly
since the anthrax attacks of 2001. The Committee notes,
however, that the Federal enterprise to develop such
countermeasures is still maturing, and improved interagency
collaboration is necessary. The Committee, through its
oversight work, has observed a need to set forth improved
agreements among the departments and agencies outlined
regarding which entities should be undertaking what activities,
consistent with existing statutory authorities. These
agreements must occur among the departments outlined above, and
also within the several agencies of the Department of Health
and Human Services engaged in such work, including the National
Institutes of Health, the Biomedical Advanced Research and
Development Authority, and the CDC. Some areas have been
orphans--for instance, only just recently has the Department of
Homeland Security undertaken a pilot to examine prospects for a
voluntary anthrax vaccination program for first responders, a
notion that languished for years without any one agency taking
responsibility for it. On the other hand, the lines between
basic and advanced research are sometimes blurred, leading to
the potential for duplicative and/or uncoordinated research
initiatives.
Sec. 402. National Medical Countermeasure Dispensing
Strategy.
Section 402 requires the Secretary of Health and Human
Services, in coordination with the Secretary of Homeland
Security, the Secretary of Agriculture, and the heads of other
appropriate Federal agencies, to develop and implement a
National Medical Countermeasure Dispensing Strategy to enhance
preparedness and collective response to an attack on humans or
animals with a CBRN agent. The strategy shall consider a
variety of options for dispensing medical countermeasures;
post-incident requirements for emergency use authorizations;
the inclusion of locally held caches in such authorizations;
and the distribution of home medical kits for personal
stockpiling within 30 days of an attack. The Secretary shall
coordinate the strategy with key stakeholders, including FEMA,
and shall provide the strategy to appropriate congressional
committees within one year of the date of enactment of the Act.
The WMD Commission's initial report found the nation's
capability to respond rapidly to a biological attack and
thereby prevent the infliction of mass casualties to be
lacking, and subsequent report cards have found the same.
Although capabilities have improved considerably since the
anthrax attacks of 2001, the Committee remains concerned that a
mass event would still overwhelm current capabilities in most
places. The Committee recognizes that the Department of Health
and Human Services has addressed medical countermeasures
dispensing to some extent in the National Health Security
Strategy, and intends for the Department to give enhanced focus
to developing a strategy for dispensing medical
countermeasures. That detailed strategy should include an
implementation plan and be adaptable to the needs of local
jurisdictions. In coordinating with State, local, and Tribal
authorities, the private sector, and non-governmental
organizations, the Secretary is particularly encouraged to seek
input from State and local public health officials and from the
first responder community. The strategy should provide a
connection between its recommendations for State and local
governments and FEMA concepts of operations.
Sec. 403. National pre-event vaccination and antimicrobial
dispensing policy review.
Section 403 requires the Secretary of Health and Human
Services, in coordination with the Secretary of Homeland
Security and the Secretary of Agriculture, to review the
adequacy of domestic vaccination and antimicrobial dispensing
policy, guidance, and information provided to the public in
light of known terrorist risks of biological attacks or events
with significant health consequences to the United States.
Considerations for the review include such matters as the
applicability of shelf life extension programs to locally held
stockpiles, provision of expiring products to international
organizations or foreign partners, the implications for public
health of pre-event vaccination and antimicrobial dispensing to
livestock, and ways to increase coordination between the
Strategic National Stockpile and the National Veterinary
Stockpile. The Department of Homeland Security terrorism risk
assessments and material threat determinations, as well as
emerging intelligence, should inform the review. The Secretary
shall report to the appropriate congressional committees within
one year of enactment with the review and with recommendations.
The Committee notes that current vaccination policy
appropriately varies according to threat and risk from specific
agents, and does not require that vaccines for potential
bioterrorism agents be provided in advance of the terrorist use
of biological agents. The Committee believes that vaccination
policy should align with material threat determinations, and
reviews should be undertaken periodically to determine which,
if any, countermeasures in the national stockpile should be
made available for pre-event dispensing. The Committee is aware
that the Public Health Emergency Medical Countermeasures
Enterprise develops utilization policies for countermeasures in
the Strategic National Stockpile, and the Committee believes
that pre-event usage should be part of these discussions. In
carrying out this section, the designated departments should
take into consideration the views of public health, public
safety, and homeland security experts. The Committee also
intends for this examination to specifically address (in
addition to other issues deemed important by the Secretaries)
voluntary immunization of first responders, further pre-
distribution of antimicrobials to the public or a subset of the
public, and sending expired vaccine and antimicrobials from the
national stockpile to other countries that could make immediate
use of these expiring medicines.
Sec. 404. Management of short shelf life vaccine and
antimicrobial stockpiles.
Section 404 requires the Secretary of Health and Human
Services to make available on a voluntary basis surplus
vaccines and antimicrobials, and vaccines and antimicrobials
with short shelf lives, from the Strategic National Stockpile
to State, local, and Tribal first responders.
The Committee is aware of and supports recent work
undertaken by the Department of Homeland Security to establish
a pilot program to provide otherwise-expiring anthrax vaccine
from the national stockpile to first responders. The approach,
however, appears to be ad hoc. While this section is non-
specific as to which countermeasures should be provided, it is
the intent of the Committee that the Secretary of Health and
Human Services engage in a thorough determination of which of
the countermeasures maintained in the stockpile warrant
voluntary provision to first responders, and for which such
provision would be feasible.
Sec. 405. Material threat determinations reviews.
Section 405 amends the Public Health Service Act (42
U.S.C.) to require review of existing material threat
determinations to determine whether these agents continue to
present a material threat against the United States population
sufficient to affect national security and homeland security.
Recognizing the evolving nature of CBRN threats, advances
in technology, and changing priorities, this section requires
the Secretary of Homeland Security, in consultation with the
Secretary of Health and Human Services and the heads of other
appropriate Federal departments and agencies, to review and
reassess existing material threat determinations and decide
whether the agents addressed continue to present material
threats against the United States population. The Committee
recognizes that some agents pose material threats to the
Nation; it acknowledges, however, the possibility that these
agents may not always pose material threats or the same level
of threat over time. The Committee intends for the list of
material threat agents to be composed of agents that present
current material threats to the nation. The Committee also
intends for agents to be removed from this list when they no
longer pose such a material threats. Additionally, the
Committee intends for these decisions to be made in
consideration of availability of medical and other
countermeasures, new science and technologies, immunization
rates, and other relevant factors.
Sec. 406. Background checks.
Section 406 amends the ``Public Health Service Act'' to
require the Attorney General to coordinate with the Secretary
of Homeland Security, the Secretary of Defense, and the
Secretary of State to determine if these departments possess
any information relevant to the identification of individuals
who should not be given access to select agents because they
are reasonably suspected of involvement with an organization
that engages in domestic or international terrorism or with any
other organization that engages in domestic or international
terrorism or crimes of violence.
The Committee intends for Federal agencies to share
information on individuals that should not be provided access
to Select Agents, in order to prevent duplication of background
investigations and the inappropriate accessing of Select
Agents. The Committee intends for all previous legislation
addressing background investigations, sole use considerations,
etc., to remain in place.
Sec. 407. State, local, and tribal defined.
In this title, the term ``State, local, and tribal'' has
the same meaning that term has in the ``Homeland Security Act
of 2002.''
Title V--Foreign Relations Matters
Sec. 501. International engagement to enhance biodefense and
laboratory biosecurity.
Section 501 requires the Secretary of State, in
consultation with the Special Assistant to the President for
Biodefense and the heads of appropriate Federal agencies, to
comprehensively address biosecurity in the international arena.
Issues to be addressed include criminalizing the use of
biological weapons or acts of bioterrorism, prevention of
bioterrorism and the misuse use of life sciences, supporting
efforts to enhance biosecurity and biosafety, and information
sharing.
The Committee recognizes that in order to achieve true
security, a culture of security awareness must be engendered in
the life sciences, not just domestically but also
internationally. The Committee intends that the work required
under this section build upon engagement activities being
undertaken by the Department of State.
Sec. 502. International collaboration and information sharing
relating to biosecurity.
Section 502 directs the Secretary of State, in consultation
with the Secretary of Homeland Security, the Secretary of
Agriculture, the Secretary of Health and Human Services, and
the heads of other agencies, to support efforts in other
countries to share information regarding biological attacks and
events with significant health consequences through United
Nations organizations; to advance awareness of the global
availability of life science information and its potential dual
use risk; and to promote the development of information sharing
mechanisms.
Information sharing, both in terms of intelligence of
ongoing events and in pre-event preparedness and education, is
critical domestically and internationally. Much as these themes
have been addressed in the domestic sections of this Act, the
Committee intends an interagency approach to fostering these
same goals overseas.
Sec. 503. Interagency task force on best practices for global
biopreparedness.
Section 503 requires the Secretary of State to convene an
interagency taskforce to examine the State of global
preparedness for a major biological attack or event and
identify best practices for preparedness based on lessons
learned from domestic efforts that may be useful or applicable
internationally. The task force shall include representatives
from the Department of Homeland Security, the Department of
Health and Human Services, the Department of Agriculture, the
Department of Defense, the Department of Justice, the
Department of State, the Director of National Intelligence,
other appropriate Federal departments and agencies, and other
appropriate national biosecurity and biodefense stakeholders.
The Committee recognizes that the United States is ahead of
many nations with respect to efforts to prevent, protect
against, respond to, and recover from CBRN attacks. The
Committee also recognizes that other countries may benefit from
United States' lessons learned, best practices, and other
information as they work to undertake these activities. The
Committee intends for the Federal government to gather and
communicate this information to other countries, as
appropriate, and by building upon existing frameworks and fora
in which the Department of State participates, without
compromising homeland and national security.
Sec. 504. Biological and Toxin Weapons Convention.
Section 504 requires the Secretary of State to promote the
Biological and Toxin Weapons Convention by promoting
transparency, pursuing compliance diplomatically, promoting
universal membership, developing an action plan for increasing
international adherence, and ensuring United States
participation in meetings is broadly inclusive of
representatives from relevant Federal agencies.
The Biological and Toxin Weapons Convention, while
imperfect in large part due to verification challenges, is one
of the best tools at the disposal of the international
community to limit the development, production, and acquisition
of biological and toxin weapons. While the origin of the threat
of biological weapons development has largely shifted since the
Convention's inception from state actors toward non-state
actors, the Convention is still relevant. The Committee
recognizes that the Department of State has been working to
promote adherence to the Convention, and intends for the
leadership role of the Department of State to be maintained and
strengthened in the parameters outlined, and particularly to
ensure that the expertise of the many Federal agencies that
work in the biodefense space is integrated into the approach.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
HOMELAND SECURITY ACT OF 2002
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) * * *
(b) Table of Contents.--The table of contents for this Act is
as follows:
* * * * * * *
TITLE III--SCIENCE AND TECHNOLOGY IN SUPPORT OF HOMELAND SECURITY
* * * * * * *
[Sec. 316. National Biosurveillance Integration Center.]
* * * * * * *
TITLE XXI--WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS
Subtitle A--Prevention
Sec. 2101. Weapons of mass destruction intelligence and information
sharing.
Sec. 2102. Risk assessments.
Sec. 2103. National Export Enforcement Coordination.
Sec. 2104. Communication of threat information.
Sec. 2105. Individual and community preparedness for chemical,
biological, radiological, and nuclear attacks.
Subtitle B--Protection
Sec. 2121. Detection of biological attacks.
Sec. 2122. Rapid biological threat detection and identification at ports
of entry.
Sec. 2123. Evaluating detection technology.
Sec. 2124. Domestic implementation of the Global Nuclear Detection
Architecture.
Subtitle C--Response
Sec. 2131. First responder guidance concerning chemical, biological,
radiological, and nuclear attacks.
Sec. 2132. Integrated plume modeling for collective response.
Sec. 2133. Establishment of the system assessment and validation for
emergency responders (SAVER) program.
Sec. 2134. Payment for laboratory response services.
Sec. 2135. Bioforensics capabilities.
Sec. 2136. Metropolitan Medical Response System Program.
Subtitle D--Recovery
Sec. 2141. Identifying and addressing gaps in recovery capabilities.
Sec. 2142. Recovery from a chemical, biological, radiological, and
nuclear attack or incident.
Sec. 2143. Exercises.
SEC. 2. DEFINITIONS.
In this Act, the following definitions apply:
(1) * * *
* * * * * * *
(19) The term ``Intelligence Community'' has the
meaning given that term in section 3(4) of the National
Security Act of 1947 (50 U.S.C. 401a(4)).
(20) The term ``national biosecurity and biodefense
stakeholders'' means officials from the Federal, State,
local, and tribal authorities and individuals from the
private sector who are involved in efforts to prevent,
protect against, respond to, and recover from a
biological attack or other biological incidents that
may have serious health or economic consequences for
the United States, including wide-scale fatalities or
infectious disease outbreaks.
* * * * * * *
TITLE II--INFORMATION ANALYSIS AND INFRASTRUCTURE PROTECTION
Subtitle A--Information and Analysis and Infrastructure Protection;
Access to Information
SEC. 201. INFORMATION AND ANALYSIS AND INFRASTRUCTURE PROTECTION.
(a) * * *
* * * * * * *
(d) Responsibilities of Secretary Relating To Intelligence
and Analysis and Infrastructure Protection.--The
responsibilities of the Secretary relating to intelligence and
analysis and infrastructure protection shall be as follows:
(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
public, in order to assist in preventing, deterring, or
responding to acts of terrorism against the United
States.
* * * * * * *
TITLE III--SCIENCE AND TECHNOLOGY IN SUPPORT OF HOMELAND SECURITY
* * * * * * *
[SEC. 316. NATIONAL BIOSURVEILLANCE INTEGRATION CENTER.
[(a) Establishment.--The Secretary shall establish, operate,
and maintain a National Biosurveillance Integration Center
(referred to in this section as the ``NBIC''), which shall be
headed by a Directing Officer, under an office or directorate
of the Department that is in existence as of the date of the
enactment of this section.
[(b) Primary Mission.--The primary mission of the NBIC is
to--
[(1) enhance the capability of the Federal Government
to--
[(A) rapidly identify, characterize,
localize, and track a biological event of
national concern by integrating and analyzing
data relating to human health, animal, plant,
food, and environmental monitoring systems
(both national and international); and
[(B) disseminate alerts and other information
to Member Agencies and, in coordination with
(and where possible through) Member Agencies,
to agencies of State, local, and tribal
governments, as appropriate, to enhance the
ability of such agencies to respond to a
biological event of national concern; and
[(2) oversee development and operation of the
National Biosurveillance Integration System.
[(c) Requirements.--The NBIC shall detect, as early as
possible, a biological event of national concern that presents
a risk to the United States or the infrastructure or key assets
of the United States, including by--
[(1) consolidating data from all relevant
surveillance systems maintained by Member Agencies to
detect biological events of national concern across
human, animal, and plant species;
[(2) seeking private sources of surveillance, both
foreign and domestic, when such sources would enhance
coverage of critical surveillance gaps;
[(3) using an information technology system that uses
the best available statistical and other analytical
tools to identify and characterize biological events of
national concern in as close to real-time as is
practicable;
[(4) providing the infrastructure for such
integration, including information technology systems
and space, and support for personnel from Member
Agencies with sufficient expertise to enable analysis
and interpretation of data;
[(5) working with Member Agencies to create
information technology systems that use the minimum
amount of patient data necessary and consider patient
confidentiality and privacy issues at all stages of
development and apprise the Privacy Officer of such
efforts; and
[(6) alerting Member Agencies and, in coordination
with (and where possible through) Member Agencies,
public health agencies of State, local, and tribal
governments regarding any incident that could develop
into a biological event of national concern.
[(d) Responsibilities of the Directing Officer of the NBIC.--
[(1) In general.--The Directing Officer of the NBIC
shall--
[(A) on an ongoing basis, monitor the
availability and appropriateness of
surveillance systems used by the NBIC and those
systems that could enhance biological
situational awareness or the overall
performance of the NBIC;
[(B) on an ongoing basis, review and seek to
improve the statistical and other analytical
methods used by the NBIC;
[(C) receive and consider other relevant
homeland security information, as appropriate;
and
[(D) provide technical assistance, as
appropriate, to all Federal, regional, State,
local, and tribal government entities and
private sector entities that contribute data
relevant to the operation of the NBIC.
[(2) Assessments.--The Directing Officer of the NBIC
shall--
[(A) on an ongoing basis, evaluate available
data for evidence of a biological event of
national concern; and
[(B) integrate homeland security information
with NBIC data to provide overall situational
awareness and determine whether a biological
event of national concern has occurred.
[(3) Information sharing.--
[(A) In general.--The Directing Officer of
the NBIC shall--
[(i) establish a method of real-time
communication with the National
Operations Center;
[(ii) in the event that a biological
event of national concern is detected,
notify the Secretary and disseminate
results of NBIC assessments relating to
that biological event of national
concern to appropriate Federal response
entities and, in coordination with
relevant Member Agencies, regional,
State, local, and tribal governmental
response entities in a timely manner;
[(iii) provide any report on NBIC
assessments to Member Agencies and, in
coordination with relevant Member
Agencies, any affected regional, State,
local, or tribal government, and any
private sector entity considered
appropriate that may enhance the
mission of such Member Agencies,
governments, or entities or the ability
of the Nation to respond to biological
events of national concern; and
[(iv) share NBIC incident or
situational awareness reports, and
other relevant information, consistent
with the information sharing
environment established under section
1016 of the Intelligence Reform and
Terrorism Prevention Act of 2004 (6
U.S.C. 485) and any policies,
guidelines, procedures, instructions,
or standards established under that
section.
[(B) Consultation.--The Directing Officer of
the NBIC shall implement the activities
described in subparagraph (A) consistent with
the policies, guidelines, procedures,
instructions, or standards established under
section 1016 of the Intelligence Reform and
Terrorism Prevention Act of 2004 (6 U.S.C. 485)
and in consultation with the Director of
National Intelligence, the Under Secretary for
Intelligence and Analysis, and other offices or
agencies of the Federal Government, as
appropriate.
[(e) Responsibilities of the NBIC Member Agencies.--
[(1) In general.--Each Member Agency shall--
[(A) use its best efforts to integrate
biosurveillance information into the NBIC, with
the goal of promoting information sharing
between Federal, State, local, and tribal
governments to detect biological events of
national concern;
[(B) provide timely information to assist the
NBIC in maintaining biological situational
awareness for accurate detection and response
purposes;
[(C) enable the NBIC to receive and use
biosurveillance information from member
agencies to carry out its requirements under
subsection (c);
[(D) connect the biosurveillance data systems
of that Member Agency to the NBIC data system
under mutually agreed protocols that are
consistent with subsection (c)(5);
[(E) participate in the formation of strategy
and policy for the operation of the NBIC and
its information sharing;
[(F) provide personnel to the NBIC under an
interagency personnel agreement and consider
the qualifications of such personnel necessary
to provide human, animal, and environmental
data analysis and interpretation support to the
NBIC; and
[(G) retain responsibility for the
surveillance and intelligence systems of that
department or agency, if applicable.
[(f) Administrative Authorities.--
[(1) Hiring of experts.--The Directing Officer of the
NBIC shall hire individuals with the necessary
expertise to develop and operate the NBIC.
[(2) Detail of personnel.--Upon the request of the
Directing Officer of the NBIC, the head of any Federal
department or agency may detail, on a reimbursable
basis, any of the personnel of that department or
agency to the Department to assist the NBIC in carrying
out this section.
[(g) NBIC Interagency Working Group.--The Directing Officer
of the NBIC shall--
[(1) establish an interagency working group to
facilitate interagency cooperation and to advise the
Directing Officer of the NBIC regarding recommendations
to enhance the biosurveillance capabilities of the
Department; and
[(2) invite Member Agencies to serve on that working
group.
[(h) Relationship to Other Departments and Agencies.--The
authority of the Directing Officer of the NBIC under this
section shall not affect any authority or responsibility of any
other department or agency of the Federal Government with
respect to biosurveillance activities under any program
administered by that department or agency.
[(i) Authorization of Appropriations.--There are authorized
to be appropriated such sums as are necessary to carry out this
section.
[(j) Definitions.--In this section:
[(1) The terms ``biological agent'' and ``toxin''
have the meanings given those terms in section 178 of
title 18, United States Code.
[(2) The term ``biological event of national
concern'' means--
[(A) an act of terrorism involving a
biological agent or toxin; or
[(B) a naturally occurring outbreak of an
infectious disease that may result in a
national epidemic.
[(3) The term ``homeland security information'' has
the meaning given that term in section 892.
[(4) The term ``Member Agency'' means any Federal
department or agency that, at the discretion of the
head of that department or agency, has entered a
memorandum of understanding regarding participation in
the NBIC.
[(5) The term ``Privacy Officer'' means the Privacy
Officer appointed under section 222.]
* * * * * * *
TITLE XXI--WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS
Subtitle A--Prevention
SEC. 2101. WEAPONS OF MASS DESTRUCTION INTELLIGENCE AND INFORMATION
SHARING.
(a) In General.--The Office of Intelligence and Analysis of
the Department shall--
(1) conduct intelligence and information sharing
activities consistent with the National Intelligence
Strategy for Countering the Threat from Weapons of Mass
Destruction under section 201 of the WMD Prevention and
Preparedness Act of 2012 and the National Intelligence
Strategy for Countering Biological Threats under
section 202 of that Act;
(2) support homeland security-focused intelligence
analysis of terrorist actors, their claims, and their
plans to conduct attacks involving chemical,
biological, radiological, and nuclear materials against
the Nation;
(3) support homeland security-focused intelligence
analysis of global infectious disease, public health,
food, agricultural, and veterinary issues;
(4) support homeland security-focused risk analysis
and risk assessments of the homeland security hazards
described in paragraphs (2) and (3), by providing
relevant quantitative and nonquantitative threat
information;
(5) leverage existing and emerging homeland security
capabilities and structures, including fusion centers
established pursuant to section 210A, to enhance
prevention, protection, response, and recovery efforts
with respect to a chemical, biological, radiological,
or nuclear attack;
(6) share information and provide tailored analytical
support on these threats to State, local, and tribal
authorities as well as other national biosecurity and
biodefense stakeholders; and
(7) perform other responsibilities, as assigned by
the Secretary.
(b) Coordination.--Where appropriate, the Office of
Intelligence and Analysis shall coordinate with other relevant
Department components, others in the Intelligence Community,
including the National Counter Proliferation Center, and other
Federal, State, local, and tribal authorities, including
officials from high-threat areas, and enable such entities to
provide recommendations on optimal information sharing
mechanisms, including expeditious sharing of classified
information, and on how they can provide information to the
Department.
(c) Report.--
(1) In general.--Not later than 1 year after the date
of the enactment of this section and annually
thereafter, the Secretary shall report to the
appropriate congressional committees on--
(A) the intelligence and information sharing
activities under subsection (a) and of all
relevant entities within the Department to
counter the threat from weapons of mass
destruction; and
(B) the Department's activities in accordance
with relevant intelligence strategies,
including the National Intelligence Strategy
for Countering the Threat from Weapons of Mass
Destruction and the National Intelligence
Strategy for Countering Biological Threats.
(2) Assessment of implementation.--The report shall
include--
(A) a description of methods established to
assess progress of the Office of Intelligence
and Analysis in implementing this section; and
(B) such assessment.
SEC. 2102. RISK ASSESSMENTS.
(a) In General.--The Secretary, acting through the Under
Secretary for Science and Technology, shall, in coordination
with relevant Department components and other appropriate
Federal departments and agencies--
(1) produce and update periodically a terrorism risk
assessment of chemical, biological, radiological, and
nuclear threats; and
(2) produce and update periodically an integrated
terrorism risk assessment that assesses all of those
threats and compares them against one another according
to their relative risk.
(b) Methodology.--
(1) In general.--The Secretary shall--
(A) convene an interagency task force of
relevant subject matter experts to assess the
proposed methodology to be used for assessments
required under subsection (a), and to provide
recommendations to the Secretary as to the
adequacy of such methodology;
(B) conduct sensitivity analysis on each
assessment to identify and prioritize research
activities to close knowledge gaps; and
(C) consider the evolving threat from an
intelligent adversary.
(2) Inclusion in assessment.--Each assessment under
subsection (a) shall include a description of the
methodology used for the assessment.
(c) Usage.--The assessments required under subsection (a)
shall be used to inform and guide risk management decisions,
including--
(1) the threat assessments and determinations by the
Secretary regarding agents and toxins pursuant to
section 319F-2 of the Public Health Service Act;
(2) allocation of resources for research and
development for chemical, biological, radiological, and
nuclear attack prevention, protection, response, and
recovery;
(3) prioritization of medical countermeasure
research, development, acquisition, and distribution
activities and other national strategic biodefense
research;
(4) tailored risk assessments and risk mitigation
studies, as appropriate, on topics such as radiological
materials security or the economic risks of a
biological attack; and
(5) other homeland security activities as determined
appropriate by the Secretary and the heads of other
agencies.
(d) Input and Sharing.--The Secretary shall, for each
assessment required under subsection (a)--
(1) seek input from national biosecurity and
biodefense stakeholders, and other Federal, State,
local, and tribal officials involved in efforts to
prevent, protect, respond to, and recover from
chemical, biological, radiological, and nuclear
threats;
(2) ensure that written procedures are in place to
guide the interagency development of the assessments,
including for input, review, and implementation
purposes, among relevant Federal partners;
(3) share the risk assessments with Federal, State,
local and tribal officials with appropriate security
clearances and a need for the information in the
classified version; and
(4) to the maximum extent practicable, make available
an unclassified version for Federal, State, local, and
tribal officials involved in prevention and
preparedness for chemical, biological, radiological,
and nuclear events.
(e) Written Procedures.--The Secretary shall establish
written procedures for appropriate usage of the assessments
required under subsection (a), including--
(1) a description of the types of departmental
activities for which the assessments should be
considered;
(2) the extent to which the findings of the
assessments should play a role in such activities;
(3) the point in planning processes at which the
assessments should be considered; and
(4) how users can access expertise within the
Department to aid in interpretation of the results of
the assessments.
SEC. 2103. NATIONAL EXPORT ENFORCEMENT COORDINATION.
(a) Establishment.--There shall be maintained in the
Department the Export Enforcement Coordination Center, with
capability for national export enforcement coordination that is
managed by the Secretary and coordinates the export enforcement
activities among the Department, the Department of Agriculture,
the Department of Commerce, the Department of Defense, the
Department of Energy, the Department of Justice, the Department
of State, the Department of the Treasury, the Intelligence
Community, and other Federal agencies as appropriate.
(b) Responsibilities.--The Center shall--
(1) enhance Federal coordination for law enforcement
counterproliferation investigations, including
coordination and deconfliction with intelligence
counterproliferation activities;
(2) address licensing inquiries, reviews, requests,
checks, and verifications; and
(3) conduct outreach and provide training to the
export trade community.
SEC. 2104. COMMUNICATION OF THREAT INFORMATION.
(a) Findings.--Congress finds the following:
(1) The Commission on the Prevention of Weapons of
Mass Destruction Proliferation and Terrorism
recommended that ``the Federal Government should
practice greater openness of public information so that
citizens better understand the threat and the risk this
threat poses to them''.
(2) There are unique challenges for community
preparedness for attacks from weapons of mass
destruction.
(b) Communications Plan.--
(1) In general.--The Administrator of the Federal
Emergency Management Agency shall develop a
communications plan designed to provide information to
the public related to preventing, preparing for,
responding to, and recovering from chemical,
biological, radiological, and nuclear attacks;
(2) Consultation.--As appropriate, the Administrator
of the Federal Emergency Management Agency shall
consult with State, local, and tribal authorities and
coordinate with other Federal departments and agencies
in developing the communications plans under paragraph
(1).
(3) Pre-scripted messages and message templates.--
(A) In general.--The Administrator of the
Federal Emergency Management Agency shall
develop and disseminate, through an alerts and
warnings system, pre-scripted messages and
message templates for State, local, and tribal
authorities so that those authorities can
quickly and rapidly disseminate critical
information to the public in anticipation of,
during, or in the immediate aftermath of a
chemical, biological, radiological, and nuclear
attack, and to be included in the Department of
Homeland Security's lessons learned information
sharing system.
(B) Development and design.--The pre-scripted
messages or message templates shall--
(i) be developed in consultation with
State, local, and tribal authorities
and in coordination with other
appropriate Federal departments and
agencies;
(ii) be designed to provide accurate,
essential, and appropriate information
and instructions to the population
directly affected by an incident,
including information regarding an
evacuation, sheltering in place,
hospital surge operations, health, and
safety;
(iii) be designed to provide
accurate, essential, and appropriate
information and instructions to
children and other special needs
populations within the population
directly affected by an incident;
(iv) be designed to provide accurate,
essential, and appropriate information
and instructions to emergency response
providers and medical personnel
responding to an incident; and
(v) include direction for the
coordination of Federal, State, local,
and tribal communications teams.
(C) Communications formats.--The
Administrator shall develop pre-scripted
messages or message templates under this
paragraph in multiple formats to ensure
delivery--
(i) in cases where the usual
communications infrastructure is
unusable;
(ii) to individuals with disabilities
or other special needs and individuals
with limited English proficiency; and
(iii) to educational and childcare
facilities, including daycare centers,
grade schools, universities, hospitals,
and elderly care facilities.
(D) Dissemination and technical assistance.--
The Administrator shall ensure that all pre-
scripted messages and message templates
developed under this paragraph are made
available to State, local, and tribal
authorities so that those authorities may
incorporate them, as appropriate, into their
emergency plans. The Administrator shall also
make available relevant technical assistance to
those authorities to support communications
planning.
(E) Exercises.--To ensure that the pre-
scripted messages or message templates
developed under this paragraph can be
effectively utilized in a disaster or incident,
the Administrator shall incorporate Federal,
State, local, and tribal communications teams
that deliver such pre-scripted messages or
message templates into exercises, including
those conducted under the National Exercise
Program.
(4) Report.--Not later than 1 year after the date of
the enactment of this subsection, the Administrator of
the Federal Emergency Management Agency shall submit to
the appropriate congressional committees the
communications plans required to be developed under
this subsection, including pre-scripted messages or
message templates developed in conjunction with the
plans and a description of the means that will be used
to deliver these messages during such incidents.
(c) Terrorism Threat Awareness.--
(1) Terrorism threat awareness.--The Secretary, in
coordination with the Attorney General and heads of
appropriate Federal agencies, shall for purposes of
preparedness and collective response to terrorism and
for other purposes--
(A) ensure that homeland security information
concerning terrorist threats is provided to
State, local, and tribal authorities and the
public within the United States, as
appropriate; and
(B) establish a process to optimize
opportunities for qualified heads of State,
local, and tribal government entities to obtain
appropriate security clearances so that they
may receive classified threat information when
appropriate.
(2) Threat bulletins.--
(A) In general.--Consistent with the
requirements of paragraph (1), the Secretary
shall, on a timely basis, prepare unclassified
threat bulletins on chemical, biological,
radiological, and nuclear threats.
(B) Requirements.--Each assessment required
under subparagraph (A) shall--
(i) include guidance to the public
for preventing and responding to acts
of terrorism arising from such threats;
and
(ii) be made available on the
Internet Web site of the Department and
other publicly accessible Internet Web
sites, communication systems, and
information networks.
(3) Guidance to state, local, and tribal
authorities.--The Secretary, using information provided
by the terrorism risk assessments under section 2102
and material threat assessments and determinations
under the Project BioShield Act of 2004 (Public Law
108-276) and the amendments made by that Act--
(A) shall provide to State, local, and tribal
authorities written guidance on communicating
terrorism-related threats and risks to the
public within their jurisdictions; and
(B) shall identify and articulate the
governmental rationale for identifying
particular communities as being at heightened
risk of exploitation.
(4) Use of existing resources.--The Secretary shall
use Internet Web sites, communication systems, and
information networks in operation on the date of an
assessment under this subsection, and shall coordinate
with other heads of Federal departments and agencies to
provide information through existing channels to
satisfy the requirements of paragraph (2)(B)(ii). The
Secretary shall provide guidance on how State, local,
tribal, and private entities can partner with public
television stations to disseminate information provided
by the Department and shall provide information on best
practices on disseminating information to residents of
local communities, including leveraging public
television stations.
SEC. 2105. INDIVIDUAL AND COMMUNITY PREPAREDNESS FOR CHEMICAL,
BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR ATTACKS.
(a) In General.--The Secretary, acting through the
Administrator for the Federal Emergency Management Agency,
shall assist State, local, and tribal authorities in improving
and promoting individual and community preparedness and
collective response to terrorist attacks involving chemical,
biological, radiological, and nuclear materials against the
United States by--
(1) developing guidance and checklists of recommended
actions for individual and community prevention and
preparedness efforts and disseminating such guidance
and checklists to communities and individuals;
(2) updating new and existing guidance and checklists
as appropriate;
(3) disseminating to communities and individuals the
guidance developed under section 2131, as appropriate;
(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 Secretary determines
appropriate.
(b) Coordination.--The Secretary shall coordinate with
Federal departments and agencies and with private sector and
nongovernmental organizations to promote individual and
community preparedness and collective response to terrorist
attacks involving chemical, biological, radiological, and
nuclear materials against the United States.
(c) Best Practices.--In compiling guidance for individual and
community preparedness in order to carry out subsection (a)(4),
the Secretary shall give due regard to best practices based on
the experience of other agencies and countries and the
expertise of academic institutions and nongovernmental
organizations.
Subtitle B--Protection
SEC. 2121. DETECTION OF BIOLOGICAL ATTACKS.
(a) Program.--The Secretary shall carry out a program to
detect a biological attack or event that poses a high risk to
homeland security. Through such program, the Secretary shall--
(1) deploy detection capabilities to areas, based on
high risks identified by Department assessments, to
indicate the presence of biological agents;
(2) consider multiple deployment strategies including
surge capability;
(3) provide information to participating laboratories
and programs for their use in monitoring public health,
and biological material or other data from those
detectors to participating laboratories and programs
for testing and evaluation;
(4) regularly communicate with, and provide
information about the presence of biological agents to,
appropriate Federal, State, and local agencies
responsible for public health, law enforcement, and
emergency services, in a manner that ensures
transparency with the governments served by such
personnel;
(5) provide advanced planning tools, concepts of
operations (including alarm resolution protocols and
response guidance), standard operating procedures, and
training exercises (including in collaboration with
relevant national level exercises) for collective
response to and recovery from biological attacks; and
(6) provide technical assistance to jurisdictions
hosting the program to improve their ability to respond
to a detected pathogen.
(b) Program Requirements.--Under the program required under
subsection (a), the Secretary shall--
(1) enter into memoranda of agreement or interagency
agreements under the Economy Act of 1933 (31 U.S.C.
1535 et seq.) with the Director of the Centers of
Disease Control and Prevention and the Administrator of
the Environmental Protection Agency, and the heads of
other Federal departments and agencies, setting forth
roles and responsibilities, including with respect to
validating performance and developing testing protocols
for participating laboratories and coordination with
appropriate State, local, and tribal agencies;
(2) establish criteria for determining whether plans
for biological detector capabilities and coverage
sufficiently protect the United States population, and
make such determinations on an annual basis;
(3) acting through the Under Secretary for Science
and Technology, and in consultation with the Director
of the Centers for Disease Control and Prevention,
implement a process for establishing assay performance
standards and evaluation for equivalency for biological
threat assays, that--
(A) evaluates biological threat detection
assays, their protocols for use, and their
associated response algorithms for confirmation
of biological threat agents, taking performance
measures and concepts of operation into
consideration;
(B) develops interagency peer-reviewed assay
performance and equivalency standards based on
the findings of the evaluation under
subparagraph (A);
(C) requires implementation of the standards
developed under subparagraph (B) for all
Department biological detection programs;
(D) promotes use of such standards among all
other Federal biological detection programs and
makes them available to the private sector and
other end-users as appropriate; and
(E) is updated as necessary;
(4) prior to obligating funds to acquire biodetection
systems for purposes of operational testing and
evaluation, require--
(A) a determination of the sensitivity and
specificity of the currently deployed
biodetection system;
(B) an assessment of the sensitivity and
specificity of the next generation biodetection
system or systems under consideration for
acquisition and whether it meets established
operational requirements;
(C) provision of all raw data to the Science
and Technology Directorate to enable the Under
Secretary to--
(i) conduct a trade-off study
comparing the results of subparagraphs
(A) and (B); and
(ii) perform a technical readiness
assessment in accordance with section
308(b); and
(D) that the findings under subparagraph (C)
inform the cost-benefit analysis under
paragraph (5)(A) and any Departmental
acquisition review board decision regarding the
biodetection system or systems under
consideration; and
(5) prior to acquiring and deploying biodetection
technology, require--
(A) a cost-benefit analysis, including an
analysis of alternatives, that shall be
informed by the terrorism risk assessments
under section 2102;
(B) operational testing and evaluation;
(C) operational assessment by the end users
of the technology; and
(D) the Department, other relevant executive
agencies, and local jurisdictions intended to
host the systems to agree on concepts of
operations for resolving alarms.
(c) Contract Authority.--The Secretary may enter into
contracts with participating laboratories and programs for--
(1) the provision of laboratory services or other
biosurveillance activities as appropriate for purposes
of this section on a fee-for-service basis or on a
prepayment or other similar basis; and
(2) administrative and other costs related to hosting
program personnel and equipment in these laboratories
or programs.
(d) Definitions.--In this section:
(1) The term ``participating laboratory'' means a
laboratory that has been accepted as a member of the
Laboratory Response Network for Biological Terrorism
that--
(A) is fully equipped to detect and respond
quickly to acts of biological terrorism;
(B) provides biocontainment and
microbiological analysis in support of the
Department and relevant law enforcement
agencies with responsibilities for
investigating biological incidents; and
(C) supports assay evaluation, research and
development.
(2) The term ``assay'' means any scientific test that
is designed to detect the presence of a biological
threat agent that is of a type selected under criteria
established by the Secretary.
SEC. 2122. RAPID BIOLOGICAL THREAT DETECTION AND IDENTIFICATION AT
PORTS OF ENTRY.
(a) In General.--The Secretary of Homeland Security shall
require the Under Secretary for Science and Technology, in
consultation with the heads of other relevant operational
components of the Department of Homeland Security, to assess
whether the development of technological screening capabilities
for biological agents, pandemic influenza, and other infectious
diseases should be undertaken by the Directorate of Science and
Technology to support entry and exit screening at ports of
entry and for other homeland security purposes.
(b) Development of Methods.--If the Under Secretary
determines that the development of such screening capabilities
should be undertaken, the Secretary shall, to the extent
possible, initiate development of safe and effective methods
to--
(1) rapidly screen incoming persons at ports of entry
for biological agents, pandemic influenza, and other
infectious diseases; and
(2) obtain results of such screening near the point
of entry.
SEC. 2123. EVALUATING DETECTION TECHNOLOGY.
To inform the purchase of detection technology, the
Secretary, in coordination with the Director of the National
Institute of Standards and Technology, may carry out a program
to--
(1) establish near-term minimum performance metrics
to support public safety actionable activities, based
to the greatest extent practicable on voluntary
consensus standards, to evaluate the effectiveness of
detection technology for high-priority biological
agents and toxins and high-priority chemical agents;
(2) establish a process for voluntary testing and
evaluation of technology by an accredited laboratory to
demonstrate conformance to such consensus standards, or
performance metrics if standards do not exist, for the
effective detection of high-priority biological agents
and toxins and high-priority chemical agents, including
incentivization for the program through potential cost
sharing with technology manufacturers and for SAFETY
Act certification or placement on the authorized
equipment list, or both; and
(3) with permission from the detection technology
manufacturer, make available to Federal departments and
agencies, State, territorial, local, and tribal
entities, and the private sector the results of
detection system testing and evaluation under paragraph
(2).
SEC. 2124. DOMESTIC IMPLEMENTATION OF THE GLOBAL NUCLEAR DETECTION
ARCHITECTURE.
(a) Securing the Cities.--The Director of the Domestic
Nuclear Detection Office shall establish and maintain a
multilayered system of detection technologies, programs, and
guidelines designed to enhance the Nation's ability to detect
and prevent a radiological or nuclear attack in high-risk
United States cities, as determined by the Secretary.
(b) Surge Capabilities.--The Director shall develop a surge
capability for radiological and nuclear detection systems that
can be deployed within the United States rapidly in response to
actionable intelligence or warnings, and includes procurement
of appropriate technology, training, and exercises.
(c) Integration.--The programs under subsections (a) and (b)
shall be integrated into the Global Nuclear Detection
Architecture and shall inform architecture studies, technology
gaps, and research activities of the Domestic Nuclear Detection
Office.
Subtitle C--Response
SEC. 2131. FIRST RESPONDER GUIDANCE CONCERNING CHEMICAL, BIOLOGICAL,
RADIOLOGICAL, AND NUCLEAR ATTACKS.
(a) Establishment of Voluntary Guidance.--Not later than 1
year after the date of the enactment of this section, the
Secretary, in coordination with the Secretary of Health and
Human Services, the Secretary of Agriculture, the Administrator
of the Environmental Protection Agency, the Attorney General,
and the heads of other Federal departments and agencies, as
appropriate, shall--
(1) develop for police, fire, emergency medical
services, emergency management, and medical and public
health personnel, voluntary guidance for responding to
a release of chemical, biological, radiological, and
nuclear material;
(2) make such guidance available to State, local, and
tribal authorities, including primary and secondary
schools and other educational institutions,
nongovernmental organizations, the private sector, and
the public; and
(3) in developing the guidance under paragraph (1)--
(A) review the experiences of other countries
and the expertise of academic institutions and
nongovernmental organizations; and
(B) consider the unique needs of children and
other vulnerable populations.
(b) Contents.--The guidance developed under subsection (a)(1)
shall be voluntary, risk-based guidance that shall include--
(1) protective action guidance for ensuring the
security, health, and safety of emergency response
providers and their families and household contacts;
(2) specific information regarding the effects of the
chemical, biological, radiological, or nuclear material
on those exposed to the agent; and
(3) best practices for emergency response providers
to effectively diagnose, handle, and otherwise manage
individuals affected by an incident involving chemical,
biological, radiological, or nuclear material.
(c) Review and Revision of Guidance.--The Secretary shall--
(1) review the guidance developed under subsection
(a)(1) at least once every 2 years;
(2) make revisions to the guidance as appropriate;
and
(3) make any revised guidance available to State,
local, and tribal authorities, nongovernmental
organizations, the private sector, and the public.
(d) Procedures for Developing and Revising Guidance.--In
carrying out the requirements of this section, the Secretary
shall establish procedures to--
(1) enable members of the first responder and first
provider community to submit recommendations of areas
in which guidance is needed and could be developed
under subsection (a)(1);
(2) determine which entities should be consulted in
developing or revising the guidance;
(3) prioritize, on a regular basis, guidance that
should be developed or revised; and
(4) develop and disseminate the guidance in
accordance with the prioritization under paragraph (3).
SEC. 2132. INTEGRATED PLUME MODELING FOR COLLECTIVE RESPONSE.
(a) Development.--
(1) In general.--The Secretary shall acquire, use,
and disseminate the best available integrated plume
models to enable rapid response activities following a
chemical, biological, nuclear, or radiological attack
or event.
(2) Scope.--The Secretary shall--
(A) identify Federal, State, and local needs
regarding plume models and ensure the rapid
development and distribution of integrated
plume models that meet those needs to
appropriate officials of the Federal Government
and State, local, and tribal authorities to
enable immediate response to a chemical,
biological, radiological, or nuclear attack or
event;
(B) establish mechanisms for dissemination by
appropriate emergency response officials of the
integrated plume models described in paragraph
(1) to nongovernmental organizations and the
public to enable appropriate collective
response activities;
(C) ensure that guidance and training in how
to appropriately use such models are provided;
and
(D) ensure that lessons learned from
assessing the development and dissemination of
integrated plume models during exercises
administered by the Department are put into the
lessons learned information sharing system
maintained by the Department.
(b) Definitions.--For purposes of this section:
(1) The term ``plume model'' means the assessment of
the location and prediction of the spread of agents
following a chemical, biological, radiological, or
nuclear attack or event.
(2) The term ``integrated plume model'' means a plume
model that integrates protective action guidance and
other information as the Secretary determines
appropriate.
SEC. 2133. ESTABLISHMENT OF THE SYSTEM ASSESSMENT AND VALIDATION FOR
EMERGENCY RESPONDERS (SAVER) PROGRAM.
The Secretary shall carry out a program for system assessment
and validation of emergency response equipment at the
Department, to be known as the ``SAVER Program''. The Secretary
shall ensure that such program--
(1) conducts objective, impartial, practitioner-
relevant, and operationally oriented assessments and
validations of commercial emergency responder equipment
and systems, including hand-held detectors for
chemical, biological, radiological, and nuclear agents;
(2) prioritizes such evaluation based on the
technical results obtained from the program established
under section 2123, if available;
(3) is supported by a network of scientists who, in
coordination with subject matter experts, perform the
assessment and validation activities using strict
scientific and testing protocols;
(4) provides results along with other relevant
equipment information to the emergency response
provider community in an operationally useful form;
(5) provides information on equipment that falls
within the categories listed in the Department's
authorized equipment list;
(6) provides information that enables decision-makers
and responders to better select, procure, use, and
maintain emergency responder equipment; and
(7) shares such information nationally with the
emergency response provider community.
SEC. 2134. PAYMENT FOR LABORATORY RESPONSE SERVICES.
In carrying out their functions, responsibilities,
authorities, and duties to counter biological terrorism, the
Secretary, the Attorney General, and the heads of other
participating Federal agencies are authorized, subject to the
availability of appropriations, to enter into contracts with
laboratories that comprise the Laboratory Response Network for
Biological Terrorism and other federally networked laboratories
that agree to participate in such a contract, for the provision
of laboratory testing services on a fee-for-service basis or on
a prepayment or other similar basis. Prior to entering into
such a contract with any laboratory in the Laboratory Response
Network for Biological Terrorism, the Secretary, the Attorney
General, or the head of any other participating Federal agency
shall inform the Centers for Disease Control and Prevention.
SEC. 2135. BIOFORENSICS CAPABILITIES.
(a) Bioforensics Analysis Center.--There is authorized in the
Department a bioforensics analysis center to provide support
for law enforcement and intelligence-related investigations and
actions to--
(1) provide definitive bioforensics analysis in
support of the executive agencies with primary
responsibilities for preventing, deterring, responding
to, attributing, and recovering from biological
attacks; and
(2) undertake other related bioforensics activities.
(b) Payment for Services.--The center shall charge and retain
fees to reimburse the cost of any service provided to an
executive agency that requested such service.
(c) Detailee Program.--Subject to the availability of
appropriations, the Secretary may implement a program under
which executive agencies as considered appropriate by the
Secretary provide personnel, on a reimbursable basis, to the
center for the purpose of--
(1) providing training and other educational benefits
for such stakeholders to help them to better understand
the policies, procedures, and laws governing national
bioforensics activities; and
(2) bolstering the capabilities and information
sharing activities of the bioforensics analysis center
authorized under subsection (a) with national
biosecurity and biodefense stakeholders.
SEC. 2136. METROPOLITAN MEDICAL RESPONSE SYSTEM PROGRAM.
(a) In General.--The Secretary shall conduct a Metropolitan
Medical Response System Program, that shall assist State and
local governments in preparing for and responding to public
health and mass casualty incidents resulting from acts of
terrorism, natural disasters, and other man-made disasters.
(b) Financial Assistance.--
(1) Authorization of grants.--
(A) In general.--The Secretary, through the
Administrator of the Federal Emergency
Management Agency, may make grants under this
section to State and local governments to
assist in preparing for and responding to mass
casualty incidents resulting from acts of
terrorism, natural disasters, and other man-
made disasters.
(B) Consultation.--In developing guidance for
grants authorized under this section, the
Administrator shall consult with the Chief
Medical Officer.
(2) Use of funds.--A grant made under this section
may be used to support the integration of emergency
management, health, and medical systems into a
coordinated response to mass casualty incidents caused
by any hazard, including--
(A) to strengthen medical surge capacity;
(B) to strengthen mass prophylaxis
capabilities including development and
maintenance of an initial pharmaceutical
stockpile sufficient to protect first
responders, their families, and immediate
victims from a chemical or biological event,
including the procurement of home medical kits
that are approved pursuant to the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
or the Public Health Service Act (42 U.S.C. 201
et seq.), as applicable;
(C) to strengthen chemical, biological,
radiological, nuclear, and explosive detection,
response, and decontamination capabilities;
(D) to develop and maintain mass triage and
pre-hospital treatment plans and capabilities;
(E) for planning;
(F) to support efforts to strengthen
information sharing and collaboration
capabilities of regional, State, and urban
areas in support of public health and medical
preparedness;
(G) for medical supplies management and
distribution;
(H) for training and exercises;
(I) for integration and coordination of the
activities and capabilities of public health
personnel and medical care providers with those
of other emergency response providers as well
as other Federal agencies, the private sector,
and nonprofit organizations, for the forward
movement of patients; and
(J) for such other activities as the
Administrator provides.
(3) Eligibility.--
(A) In general.--Except as provided in
subparagraph (C), any jurisdiction that
received funds through the Metropolitan Medical
Response System Program in fiscal year 2009
shall be eligible to receive a grant under this
section.
(B) Additional jurisdictions.--
(i) Unrepresented states.--
(I) In general.--Except as
provided in subparagraph (C),
the Administrator may make
grants under this section to
the metropolitan statistical
area with the largest
population in any State in
which no jurisdiction received
funds through the Metropolitan
Medical Response Program in
fiscal year 2009, or in which
funding was received only
through another State.
(II) Limitation.--For each of
fiscal years 2012 through 2014,
no jurisdiction that would
otherwise be eligible to
receive grants under subclause
(I) shall receive a grant under
this section if it would result
in any jurisdiction under
subparagraph (A) receiving less
funding than such jurisdiction
received in fiscal year 2009.
(ii) Other jurisdictions.--
(I) In general.--Subject to
subparagraph (C), the
Administrator may determine
that additional jurisdictions
are eligible to receive grants
under this section.
(II) Limitation.--For each of
fiscal years 2012 through 2014,
the eligibility of any
additional jurisdiction to
receive grants under this
section is subject to the
availability of appropriations
beyond that necessary to--
(aa) ensure that each
jurisdiction eligible
to receive a grant
under subparagraph (A)
does not receive less
funding than such
jurisdiction received
in fiscal year 2009;
and
(bb) provide grants
to jurisdictions
eligible under clause
(i).
(C) Performance requirement after fiscal year
2012.--A jurisdiction shall not be eligible for
a grant under this subsection from funds
available after fiscal year 2012 unless the
Secretary determines that the jurisdiction
maintains a sufficient measured degree of
capability in accordance with the performance
measures issued under subsection (c).
(4) Distribution of funds.--
(A) In general.--The Administrator shall
distribute grant funds under this section to
the State in which the jurisdiction receiving a
grant under this section is located.
(B) Pass through.--Subject to subparagraph
(C), not later than 45 days after the date on
which a State receives grant funds under
subparagraph (A), the State shall provide the
jurisdiction receiving the grant 100 percent of
the grant funds, and not later than 45 days
after the State releases the funds, all fiscal
agents shall make the grant funds available for
expenditure.
(C) Exception.--The Administrator may permit
a State to provide to a jurisdiction receiving
a grant under this section 97 percent of the
grant funds awarded if doing so would not
result in any jurisdiction eligible for a grant
under paragraph (3)(A) receiving less funding
than such jurisdiction received in fiscal year
2009.
(5) Regional coordination.--The Administrator shall
ensure that each jurisdiction that receives a grant
under this section, as a condition of receiving such
grant, is actively coordinating its preparedness
efforts with surrounding jurisdictions, with the
official with primary responsibility for homeland
security (other than the Governor) of the government of
the State in which the jurisdiction is located, and
with emergency response providers from all relevant
disciplines, as determined by the Administrator, to
effectively enhance regional preparedness.
(c) Performance Measures.--The Administrator of the Federal
Emergency Management Agency, in coordination with the Chief
Medical Officer, and the National Metropolitan Medical Response
System Working Group, shall issue performance measures within 1
year after the date of enactment of this section that enable
objective evaluation of the performance and effective use of
funds provided under this section in any jurisdiction.
(d) Metropolitan Medical Response System Working Group
Defined.--In this section, the term ``National Metropolitan
Medical Response System Working Group'' means--
(1) 10 Metropolitan Medical Response System Program
grant managers, who shall--
(A) include 1 such grant manager from each
region of the Agency;
(B) comprise a population-based cross section
of jurisdictions that are receiving grant funds
under the Metropolitan Medical Response System
Program; and
(C) include--
(i) 3 selected by the Administrator
of the Federal Emergency Management
Agency; and
(ii) 3 selected by the Chief Medical
Officer; and
(2) 3 State officials who are responsible for
administration of State programs that are carried out
with grants under this section, who shall be selected
by the Administrator.
(e) Authorization of Appropriations.--There is authorized to
be appropriated $42,000,000 to carry out the program for each
of fiscal years 2012 through 2016.
Subtitle D--Recovery
SEC. 2141. IDENTIFYING AND ADDRESSING GAPS IN RECOVERY CAPABILITIES.
(a) Risk Assessment.--
(1) Tailored risk assessment.--The Secretary, acting
through the Under Secretary for Science and Technology
and in coordination with the Administrator of the
Environmental Protection Agency, shall conduct tailored
risk assessments to inform prioritization of national
recovery activities for chemical, biological,
radiological, and nuclear incidents, to be updated as
necessary.
(2) Considerations.--In conducting the risk
assessments under paragraph (1), the Secretary shall--
(A) consult with the Secretary of Health and
Human Services, the Secretary of Agriculture,
the Secretary of the Interior, the Chairman of
the Nuclear Regulatory Commission, and the
heads of other relevant Federal departments and
agencies;
(B) consider recovery of both indoor areas
and outdoor environments; and
(C) consider relevant studies previously
prepared by other Federal agencies, or other
appropriate stakeholders.
(3) Collaboration.--Upon completion of the risk
assessments required by this section, the Secretary
shall provide the findings to the Administrator of the
Environmental Protection Agency and heads of other
relevant Federal agencies in order to inform ongoing
and future work, including research and guidance
development, undertaken by those agencies in recovery
and remediation from chemical, biological,
radiological, or nuclear incidents.
(b) Research.--The results of the risk assessment under this
section shall inform appropriate Federal research to address
the high-risk capability gaps uncovered by each assessment.
(c) Submission to Congress.--The results of each risk
assessment shall be submitted to the appropriate congressional
committees within 30 days after completion of the assessment.
SEC. 2142. RECOVERY FROM A CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND
NUCLEAR ATTACK OR INCIDENT.
(a) Establishment of Guidance.--The Secretary shall develop
and issue guidance for clean-up and restoration of indoor and
outdoor areas, including subways and other mass transportation
facilities, that have been exposed to chemical, biological,
radiological, or nuclear materials. The Secretary shall develop
and issue the guidance, within 24 months after the date of
enactment of this section, in consultation with--
(1) the Secretary of Agriculture;
(2) the Secretary of Commerce;
(3) the Secretary of Education;
(4) the Secretary of the Interior;
(5) the Attorney General;
(6) the Secretary of Labor;
(7) the Secretary of Transportation;
(8) the Secretary of Housing and Urban Development;
(9) the Secretary of Health and Human Services;
(10) the Secretary of Veterans Affairs;
(11) the Secretary of the Treasury;
(12) the Administrator of the Environmental
Protection Agency; and
(13) the Administrator of the Small Business
Administration.
(b) Contents.--The guidance developed under subsection (a)
shall clarify Federal roles and responsibilities for assisting
State, local, and tribal authorities and include risk-based
recommendations for--
(1) standards for effective decontamination of
affected sites;
(2) standards for safe post-event occupancy of
affected sites, including for vulnerable populations
such as children and individuals with health concerns;
(3) requirements to ensure that the decontamination
procedures for responding organizations do not
conflict;
(4) requirements that each responding organization
uses a uniform system for tracking costs and
performance of clean-up contractors;
(5) maintenance of negative air pressure in
buildings;
(6) standards for proper selection and use of
personal protective equipment;
(7) air sampling procedures;
(8) development of occupational health and safety
plans that are appropriate for the specific risk to
responder health; and
(9) waste disposal.
(c) Review and Revision of Guidance.--The Secretary shall--
(1) not less frequently than once every 2 years,
review the guidance developed under subsection (a);
(2) make revisions to the guidance as appropriate;
and
(3) make the revised guidance available to the
Federal Government, State, local, and tribal
authorities, nongovernmental organizations, the private
sector, and the public.
(d) Procedures for Developing and Revising Guidance.--In
carrying out the requirements of this section, the Secretary
shall establish procedures to--
(1) prioritize issuance of guidance based on the
results of the risk assessment under section 2131;
(2) inventory existing relevant guidance;
(3) enable the public to submit recommendations of
areas in which guidance is needed;
(4) determine which entities should be consulted in
developing or revising the guidance;
(5) prioritize, on a regular basis, guidance that
should be developed or revised; and
(6) develop and disseminate the guidance in
accordance with the prioritization under paragraph (5).
(e) Consultations.--The Secretary shall develop and revise
the guidance developed under subsection (a), and the procedures
required under subsection (d), in consultation with--
(1) the heads of other Federal departments and
agencies that are not required to be consulted under
subsection (a), as the Secretary considers appropriate;
(2) State, local, and tribal authorities; and
(3) nongovernmental organizations and private
industry.
(f) Report.--Not later than 1 year after the date of the
enactment of this section, and annually thereafter, the
Secretary shall provide appropriate congressional committees
with--
(1) a description of the procedures established under
subsection (d);
(2) any guidance in effect on the date of the report;
(3) a list of entities to which the guidance
described in paragraph (2) was disseminated;
(4) a plan for reviewing the guidance described in
paragraph (2), in accordance with subsection (e);
(5) the prioritized list of the guidance required
under subsection (d)(4), and the methodology used by
the Secretary for such prioritization; and
(6) a plan for developing, revising, and
disseminating the guidance.
SEC. 2143. EXERCISES.
(a) In General.--To facilitate recovery from a chemical,
biological, radiological, or nuclear attack or other incident
involving chemical, biological, radiological, or nuclear
materials and to foster collective response to terrorism, the
Secretary shall develop exercises in consultation with State,
local, and tribal authorities and other appropriate Federal
agencies, and, as appropriate, in collaboration with national
level exercises, including exercises that address, to the best
knowledge available at the time, analysis, indoor environmental
cleanup methods, and decontamination standards, including those
published in the guidance issued under section 2142.
(b) Lessons Learned for National Level Exercises.--The
Secretary shall provide electronically, to the maximum extent
practicable, lessons learned reports to each designated
representative of State, local, and tribal jurisdictions and
private sector entities that participate in National Level
Exercises of the Department. Each lessons learned report shall
be tailored to convey information on that exercise that could
be leveraged to enhance preparedness and response.
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PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part B--Federal-State Cooperation
* * * * * * *
SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE AND SECURITY COUNTERMEASURE
PROCUREMENTS.
(a) * * *
* * * * * * *
(c) Additional Authority Regarding Procurement of Certain
Countermeasures; Availability of Special Reserve Fund.--
(1) * * *
(2) Determination of material threats.--
(A) Material threat.--The Homeland Security
Secretary, in consultation with the Secretary
and the heads of other agencies as appropriate,
shall on an ongoing basis--
(i) assess current and emerging
threats of chemical, biological,
radiological, and nuclear agents; [and]
(ii) establish criteria for the
issuance of a material threat
determination;
[(ii)] (iii) determine which of such
agents present a material threat
against the United States population
sufficient to affect national
security[.]; and
(iv) review and reassess
determinations under clause (iii) to
determine whether agents continue to
present a material threat against the
United States population sufficient to
affect national security and homeland
security.
* * * * * * *
SEC. 319F-5. NATIONAL MEDICAL COUNTERMEASURE DISPENSING STRATEGY.
(a) Definitions.--In this section--
(1) the term ``dispense'' means to provide medical
countermeasures to an affected population in response
to a threat or incident; and
(2) the term ``medical countermeasure'' means a
qualified countermeasure (as defined in section 319F-
1(a)(2)).
(b) Strategy.--
(1) In general.--The Secretary, in coordination with
the Secretary of Homeland Security, the Secretary of
Agriculture, and other appropriate Federal agencies,
shall develop, implement, and, as appropriate,
periodically update a National Medical Countermeasure
Dispensing Strategy to enhance preparedness and
collective response to a terrorist attack on humans or
animals with any chemical, biological, radiological, or
nuclear material, that delineates Federal, State, and
local responsibilities.
(2) Considerations.--The strategy shall be
sufficiently flexible to meet the unique needs of
different communities, including first responders, and
shall consider--
(A) a variety of options for dispensing
medical countermeasures, including to
individuals, schools, universities, hospitals,
and elderly care facilities;
(B) post-incident requirements for emergency
use authorizations before countermeasures can
be distributed legally;
(C) the inclusion of locally held caches of
countermeasures in event-specific
authorizations covering federally held
countermeasures of the same type; and
(D) distribution to the public of home
medical kits for personal stockpiling purposes,
within 30 days after a domestic or
international bioterrorist attack resulting in
human infection.
(c) Coordination.--The Secretary shall coordinate with the
Administrator of the Federal Emergency Management Agency,
State, local, and tribal authorities, representatives from the
private sector, and nongovernmental organizations on the
National Medical Countermeasures Dispensing Strategy.
(d) Report.--Not later than 1 year after the date of the
enactment of this section, the Secretary shall submit the
National Medical Countermeasures Dispensing Strategy to the
appropriate congressional committees.
* * * * * * *
Part F--Licensing--Biological Products and Clinical Laboratories
Subpart 1--Biological Products
* * * * * * *
SEC. 351A. ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS AND TOXINS.
(a) * * *
* * * * * * *
(e) Safeguard and Security Requirements for Registered
Persons.--
(1) * * *
* * * * * * *
(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, the Secretary
of Defense, and the Secretary of State to
determine whether these officials possess any
information relevant to the identification of
such an individual by the Attorney General.
* * * * * * *
ADDITIONAL VIEWS
While I agree with most of views expressed in the
underlying report, it is unfortunate that the report seems to
give the impression that the President's decision on how to
organize White House-level staff to address the WMD threat, on
its face, reflects a lack of seriousness about the biosecurity
threat. President Obama has shown leadership in the area of
biosecurity. The President issued a ``National Strategy for
Countering Biological Threats'' in November 2009 that set forth
policies to ensure that the United States will be able to
prevent, protect against, and respond to both naturally-
occurring and man-made biological events by engaging in
prevention activities at home and engaging with the
international community.
As for the involvement of the ``WMD Coordinator'' in
biosecurity efforts, I would note that the WMD Coordinator's
office played a significant role in the December 2011
Biological Weapons Convention Review Conference. Additionally,
the WMD Coordinator's office was a key player in development of
the aforementioned strategy to counter biological threats.
I agree that more can and should be done to protect the
United States from a biological attack. At the same time, I
also believe the current Administration's efforts in this
regard ought to be recognized.
Bennie G. Thompson.