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111th Congress Rept. 111-659
HOUSE OF REPRESENTATIVES
2d Session Part 1
======================================================================
WMD PREVENTION AND PREPAREDNESS ACT OF 2010
_______
November 18, 2010.--Ordered to be printed
_______
Mr. Thompson of Mississippi, from the Committee on Homeland Security,
submitted the following
R E P O R T
together with
ADDITIONAL VIEWS
[To accompany H.R. 5498]
[Including cost estimate of the Congressional Budget Office]
The Committee on Homeland Security, to whom was referred the
bill (H.R. 5498) to enhance homeland security by improving
efforts to prevent, deter, prepare for, detect, attribute,
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.......................................... 30
Committee Votes.................................................. 31
Committee Oversight Findings..................................... 32
New Budget Authority, Entitlement Authority, and Tax Expenditures 32
Congressional Budget Office Estimate............................. 32
Statement of General Performance Goals and Objectives............ 37
Congressional Earmarks, Limited Tax Benefits, and Limited Tariff
Benefits....................................................... 39
Federal Mandates Statement....................................... 39
Advisory Committee Statement..................................... 39
Constitutional Authority Statement............................... 39
Applicability to Legislative Branch.............................. 39
Section-by-Section Analysis of the Legislation................... 39
Changes in Existing Law Made by the Bill, as Reported............ 71
Additional, Minority, and Dissenting Views....................... 107
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 2010''.
(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--INTELLIGENCE MATTERS
Sec. 101. National intelligence strategy for countering the threat from
weapons of mass destruction.
Sec. 102. National intelligence strategy for countering biological
threats.
TITLE II--HOMELAND SECURITY MATTERS
Sec. 201. Weapons of mass destruction prevention and preparedness.
Sec. 202. Definitions.
Sec. 203. Dual-use terrorist risks from synthetic genomics.
Sec. 204. Dissemination of information analyzed by the Department to
State, local, tribal, and private entities with responsibilities
relating to homeland security.
Sec. 205. National Biosurveillance Integration Center (NBIC).
Sec. 206. Report on establishment of the system assessment and
validation for emergency responders (SAVER) program.
Sec. 207. National Academy of Sciences study of forensic science in
homeland security.
Sec. 208. Harmonization of regulations.
Sec. 209. Communications planning for weapons of mass destruction
information dissemination.
Sec. 210. Environmental recovery from chemical, biological,
radiological, and nuclear attacks.
TITLE III--PUBLIC HEALTH MATTERS
Sec. 301. National medical countermeasure dispensing strategy.
Sec. 302. Material threat assessments and determinations.
Sec. 303. National pre-event vaccination and antimicrobial dispensing
policy review.
Sec. 304. Designation of tier 1 material threat agents.
Sec. 305. Background checks.
Sec. 306. Biotechnology research, development, and procurement.
TITLE IV--FOREIGN RELATIONS MATTERS
Sec. 401. International collaboration and information sharing relating
to biosecurity.
Sec. 402. International engagement to enhance biodefense and
biosecurity.
Sec. 403. Interagency task force on best practices for global
biopreparedness.
Sec. 404. 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 ``weapon of mass destruction'' has the meaning
given that term in section 1403(1) fo the Defense Against
Weapons of Mass Destruction Act of 1996 (50 U.S.C. 2302).
(3) 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)).
(4) 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, deter, prepare for,
detect, attribute, respond, 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--INTELLIGENCE MATTERS
SEC. 101. 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) 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 threats posed by weapons of
mass destruction;
(2) include methods for collaboration, as appropriate, with
individuals with the expertise described in paragraph (1) who
are not employed by the Federal Government;
(3) identify and address domestic needs for analysis and
collection including the development of innovative human and
technical intelligence collection capabilities and techniques;
and
(4) address each type of weapon of mass destruction as
necessary and appropriate.
(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, 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) methods to disseminate intelligence products to national
biosecurity and biodefense stakeholders in 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 five-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.
(d) Coordination.--The Director of National Intelligence shall, as
the Director considers appropriate, coordinate with State, local, and
tribal government authorities, private sector, and nongovernmental
organizations in the development of the National Intelligence Strategy
for Countering the Threat from Weapons of Mass Destruction.
(e) Report.--Not later than one year after the date of the enactment
of this Act, the Director of National Intelligence, in consultation
with the Secretary of Homeland Security, 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.
SEC. 102. NATIONAL INTELLIGENCE STRATEGY FOR COUNTERING BIOLOGICAL
THREATS.
(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 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) include a for plan for establishing in the Intelligence
Community a cadre of--
(A) collectors and analysts in all agencies in the
Intelligence Community that are familiar with
biological threats, biological science, and
biotechnology;
(B) biological scientists;
(C) biotechologists; and
(D) experts with knowledge of the current state of
technologies that could be used to develop a weapon of
mass destruction;
(2) include a plan for defining the functions, capabilities,
and gaps with respect to addressing the risk of a weapon of
mass destruction attack in the intelligence workforce;
(3) identify strategies to recruit, retain, and protect such
workforce from workplace exposures to biological agents in the
conduct of the duties of such workforce;
(4) include methods for collaboration, as appropriate, with
individuals with expertise described in paragraph (1) who are
not employed by the Federal Government;
(5) address domestic and international needs for analysis and
collection;
(6) include a plan for defining, integrating, focusing, and
enhancing existing capabilities in the Intelligence Community
dedicated to current tactical and strategic biological threats;
and
(7) 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 five-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 one year after the date of the enactment
of this Act, the Director of National Intelligence, in consultation
with the Secretary of Homeland Security, 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.
TITLE II--HOMELAND SECURITY MATTERS
SEC. 201. 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 and Deterrence
``SEC. 2101. WEAPONS OF MASS DESTRUCTION INTELLIGENCE AND INFORMATION
SHARING UNIT.
``(a) In General.--There is established in the Office of Intelligence
and Analysis of the Department a unit for weapons of mass destruction
intelligence and information sharing. The unit shall conduct
intelligence and information sharing activities consistent with the
National Intelligence Strategy for Countering the Threat from Weapons
of Mass Destruction under section 101 of the WMD Prevention and
Preparedness Act of 2010 and the National Intelligence Strategy for
Countering Biological Threats under section 102 of that Act and shall--
``(1) evaluate and establish a baseline of terrorist actors,
their claims, and their plans to conduct attacks involving
chemical, biological, radiological, and nuclear materials
against the Nation;
``(2) support homeland security-focused intelligence analysis
of global infectious disease, public health, food,
agricultural, and veterinary issues;
``(3) provide tailored analytical support on these threats to
State, local, and tribal authorities as well as members of the
public health, scientific, and response communities; and
``(4) perform other responsibilities, as assigned by the
Secretary.
``(b) Coordination.--Where appropriate, the unit shall coordinate
with others in the Intelligence Community, including the National
Counter Proliferation Center.
``(c) Report.--Not later than one year after the date of the
enactment of this section and annually thereafter, the Secretary shall
report to the appropriate congressional committees on the intelligence
and information sharing activities of the unit for weapons of mass
destruction intelligence and information sharing established under
subsection (a) and all relevant entities within the Department to
counter the threat from weapons of mass destruction and how the
Department acted 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.
``SEC. 2102. INFORMATION SHARING AND COLLABORATION FOR BIOSECURITY AND
BIODEFENSE.
``(a) Responsibilities of Secretary of Homeland Security.--To
increase situational awareness, the Secretary, acting through the Under
Secretary for Intelligence and Analysis, shall--
``(1) to the greatest extent practicable, integrate into the
homeland security, intelligence, and information sharing
process national biosecurity and biodefense stakeholders;
``(2) develop an information sharing framework for homeland
security intelligence and information sharing withe national
biosecurity and biodefense stakeholders;
``(3) enable national biosecurity and biodefense stakeholders
to provide recommendations with respect to the development of
mechanisms and protocols to integrate information from national
biosecurity and biodefense stakeholders;
``(4) leverage existing and emerging homeland security
capabilities and structures, including fusion centers
established pursuant to section 210A, to enhance prevention,
detection, preparedness, and collective response, attribution,
and recovery efforts of 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; and
``(5) advance partnerships between the Department and other
Federal departments and agencies in assessing potential threats
and the risks from the intentional use of biological agents by
terrorists or other actors.
``(b) Coordination With Other Departments and Agencies.--The
Secretary shall work in coordination with the Secretary of State, the
Secretary of Agriculture, the Secretary of Health and Human Services,
and the heads of other appropriate Federal agencies.
``SEC. 2103. BIOTERRORISM RISK ASSESSMENTS.
``(a) Risk Assessment.--The Secretary, in coordination with the heads
of other appropriate Federal departments and agencies, shall produce
biennial integrated risk assessments, to be known as `Bioterrorism Risk
Assessments' to identify and assess the evolving 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. These assessments shall--
``(1) identify the threat, vulnerability, and consequences of
a biological terrorist attack against the United States;
``(2) take into account intelligence and information
regarding terrorist intentions, capabilities, plans, and
actions;
``(3) be used to inform and guide threat assessments and
determinations made by the Secretary regarding agents and
toxins pursuant to section 302(9), and to guide prioritization
of other homeland security activities, as appropriate;
``(4) provide the basis for risk-informed investments in
national strategic biodefense research, development, planning,
preparedness, and collective response to biological attacks;
``(5) identify key knowledge and data gaps;
``(6) define critical biodefense vulnerabilities;
``(7) provide risk-based prioritization of agents for
bioterrorism; and
``(8) evaluate progress in implementing national
biopreparedness policy.
``(b) Requirement.--The Secretary shall--
``(1) convene an interagency task force of subject matter
experts to provide recommendations to the Under Secretary for
Science and Technology as to the adequacy of the methodology
used in the Assessments and to establish requirements and
standards for the Assessments;
``(2) engage with national biosecurity and biodefense
stakeholders to obtain their input regarding the Assessments,
as appropriate; and
``(3) ensure, to the greatest extent practicable, that the
Assessments inform the risk management decisions of the
Department and can be made available to national biosecurity
and biodefense stakeholders, as appropriate.
``SEC. 2104. RADIOLOGICAL MATERIALS SECURITY.
``(a) Risk Assessment.--The Secretary shall enhance domestic
preparedness for and collective response to terrorism by conducting
annual risk assessments regarding the threat, vulnerability, and
consequences of theft or other procurement of radiological materials
that could be used by a terrorist in a radiological dispersion device,
including any specific threat information pertinent to the use of
radiological materials in a possible terrorist attack using a
radiological dispersion device.
``(b) Considerations.--In conducting the terrorism risk assessments
under subsection (a), the Secretary shall--
``(1) consult with Secretary of Energy, Secretary of Heath
and Human Services, and the Nuclear Regulatory Commission;
``(2) consider relevant studies previously prepared by other
Federal agencies, or other reputable sources;
``(3) focus on those radiological materials that constitute
the greatest risk, and designate those materials as high-risk
radiological materials for purposes of this section;
``(4) consider the potential radiological dispersion device
value of different radiological materials including
availability, dispersability, and ease of handling of such
materials;
``(5) consider the vulnerability for theft or other
procurement that different facilities represent; and
``(6) consider the consequences of a successful radiological
dispersion device attack, including risk of death or injury and
economic losses.
``(c) Consultation.--In conducting the terrorism risk assessments
under subsection (a), the Secretary shall consult with the Intelligence
Community, the Secretary of Energy and the Field Intelligence Elements
of the National Laboratories, and the Nuclear Regulatory Commission,
the Secretary of Health and Human Services, and other appropriate
experts to integrate and analyze information needed to develop the risk
assessment.
``(d) Dissemination of Findings.--The Secretary shall disseminate the
findings of the risk assessments and any specific risk information
developed in the assessment to all participating agencies including
those described in subsection (c), as well State and local agencies,
and the facilities containing radiological source material and
regulated by the Nuclear Regulatory Commission.
``(e) Classification.--The Secretary shall, as appropriate, share the
terrorism risk assessments with law enforcement and critical
infrastructure operators with appropriate security clearances. The
Secretary shall also make available an unclassified version to each
agency with which the Secretary is required to consult under subsection
(c), as well as State and local law enforcement and public health
authorities, and facilities possessing radiological materials with the
support of the Department of Energy.
``SEC. 2105. ENHANCED BIOSECURITY MEASURES.
``(a) Regulations.--At the request of the Secretary, the Secretary,
in consultation with the Secretary of Agriculture, the Secretary of
Health and Human Services, and the heads of other appropriate Federal
agencies, shall, through a negotiated rulemaking committee under
subchapter III of chapter 5 of title 5, United States Code, establish
enhanced biosecurity measures for persons or laboratories that possess,
use, or transfer Tier I Material Threat Agents. Such measures shall
include--
``(1) standards for personnel surety programs;
``(2) standards for biosecurity practices and training of
responsible officials, laboratory personnel, and support
personnel;
``(3) standards for performing laboratory vulnerability
assessments in collaboration with each facility;
``(4) risk-based laboratory security performance standards;
``(5) penalties (including civil money penalties and
intermediate sanctions), in addition to any other penalties
that may apply under provisions of law; and
``(6) any other security standards determined necessary by
the Secretary, the Secretary of Agriculture, Secretary of
Health and Human Services, and other agencies as appropriate.
``(b) Negotiated Rulemaking Committee.--The Secretary shall establish
a negotiated rulemaking committee for purposes of subsection (a). Such
committee shall include a representative from each of the following:
``(1) The Department.
``(2) The Department of Health and Human Services.
``(3) The Department of Agriculture.
``(4) The Department of Defense.
``(5) The Department of Energy.
``(6) The Department of Justice.
``(7) For-profit research institutions.
``(8) Academic research institutions.
``(9) Nonprofit research institutions
``(10) Other stakeholders, as the Secretary determines
appropriate.
``(c) Time Requirement.--The procedures for the negotiated rulemaking
referred to in subsection (a) shall be conducted in a timely manner to
ensure that--
``(1) any recommendations with respect to proposed
regulations are provided to the Secretary and the heads of the
other appropriate Federal agencies not later than one year
after the date of the enactment of this section; and
``(2) a final rule is promulgated not later than two years
after the date of the enactment of this section.
``(d) Factors to Be Considered.--In developing proposed and final
standards pursuant to the negotiated rulemaking referred to in
subsection (a), the negotiated rulemaking committee shall consider--
``(1) the Commission on the Prevention of Weapons of Mass
Destruction Proliferation and Terrorism (established under
section 1851 of the Implementing Recommendations of the 9/11
Commission Act of 2007 (Public Law 110-53; 121 Stat. 501));
``(2) the National Science Advisory Board for Biosecurity
(established under section 217a of title 42, United States
Code, section 222 of the Public Health Service Act, and section
205 of the Pandemic and All-Hazards Preparedness Act);
``(3) any working group established under Executive Order
13486 (74 Fed. Reg. 2289) relating to strengthening laboratory
biosecurity;
``(4) the Chemical Facility Anti-Terrorism Act of 2009; and
``(5) views from representatives of biosecurity and
biodefense stakeholders for methods to minimize any
disincentives to biological research arising from enhanced
biosecurity measures.
``(e) Implementation of Enhanced Biosecurity Measures.--
``(1) Enforcement.--The Secretary of Agriculture and the
Secretary of Health and Human Services, in consultation with
the Secretary, as appropriate, shall enforce the measures
established under subsection (a) and any standards promulgated
pursuant to such section.
``(2) Training programs.--The Secretary of Agriculture and
the Secretary of Health and Human Services, in coordination
with the Secretary and the heads of other Federal agencies, as
appropriate, shall develop training programs that comply with
such measures and standards.
``(3) Procedures.--The Secretary of Agriculture and the
Secretary of Health and Human Services, in consultation with
the Secretary and the heads of other Federal agencies, as
appropriate, shall develop and implement procedures with
respect to when and how penalties and intermediate sanctions
may be imposed. Such procedures shall provide for notice, a
reasonable opportunity to respond to the proposed penalty or
intermediate sanction, and appropriate procedures for appealing
determinations relating to the imposition of a penalty or
intermediate sanction.
``(4) Simultaneous laboratory inspections.--
``(A) Inspection data sharing and enforcement
uniformity.--The Secretary of Agriculture and the
Secretary of Health and Human Services shall
periodically provide the Secretary with all data
concerning inspections of laboratories that handle Tier
1 Material Threat Agents to ensure uniformity in
enforcement of the regulations enacted under subsection
(a) and to identify areas where the Secretary can
provide guidance to the Secretary of Agriculture or the
Secretary of Health and Human Services about approaches
to enhance security at specific laboratories.
``(B) Simultaneous inspections.--Any inspections of
the same laboratory conducted by the Secretary of
Agriculture pursuant to section 212(a)(1) of the
Agricultural Bioterrorism Protection Act of 2002 and
the Secretary of Health and Human Services for
compliance with regulations promulgated under the
Select Agent Program under section 351A(a)(1) of the
Public Health Service Act, shall be conducted
simultaneously to the extent practicable.
``(C) Common inspection procedures.--Departments
conducting simultaneous inspections of a laboratory
under this subsection shall ensure, to the maximum
extent practicable, that such inspections are conducted
using a common set of inspection procedures across such
departments in order to minimize the administrative
burden on such laboratory.
``(D) Inspection reports.--Inspection reports
generated under this paragraph shall be made available
to each Federal agency that supports select agent
laboratory activities at the institution that is the
subject of the inspection report, and to the
institutions that are the object of inspections.
``SEC. 2106. TIER I MATERIAL THREAT AGENT LOCATIONS.
``The Secretary of Agriculture and the Secretary of Health and Human
Services shall provide to the Secretary a list of laboratories and
other locations where Tier I Material Threat Agents are present in the
United States and its territories.
``SEC. 2107. HIGH CONTAINMENT BIOLOGICAL LABORATORY SECURITY GRANTS.
``(a) Grants Authorized.--The Secretary, acting through the
Administrator of the Federal Emergency Management Agency, may award
grants based on risk to academic and nonprofit organizations and to
State, local, and tribal authorities that possess, use, or transfer
Tier I Material Threat Agents, to enhance security at laboratories of
such organizations and authorities.
``(b) Authorization of Appropriations.--There is authorized to be
appropriated to the Department of Homeland Security to carry out this
subsection $50,000,000 for each of fiscal years 2011 through 2013.
``SEC. 2108. LABORATORY BIOSECURITY INFORMATION SHARING.
``(a) In General.--Consistent with the responsibilities of the
Secretary under section 201(d), the Secretary shall establish
procedures, with appropriate controls on access, for the sharing of
homeland security information, including vulnerability assessments,
security plans, best practices and other laboratory biosecurity-related
information, as the Secretary determines appropriate, with State,
local, and tribal government authorities, including law enforcement
authorities and emergency response providers.
``(b) Access to Information in Databases.--In carrying out this
section, the Secretary shall have access to and may use information
from the national databases established under section 212(d)(2) of the
Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401(d)(2))
and subsections (d)(2) and (f)(3) of section 351A of the Public Health
Service Act (42 U.S.C. 262a).
``(c) Classified and Sensitive Information.--The Secretary shall
ensure that any information disseminated under this section is handled
consistent with--
``(1) the authority of the Director of National Intelligence
to protect intelligence sources and methods under the National
Security Act of 1947 (50 U.S.C. 401 et seq.) and related
procedures or similar authorities of the Attorney General
concerning sensitive law enforcement information;
``(2) section 552a of title 5, United States Code (commonly
referred to as the Privacy Act of 1974); and
``(3) other relevant laws.
``SEC. 2109. PERIODIC HOMELAND SECURITY REVIEW OF CRIMINAL STATUTES.
``(a) In General.--The Secretary, in coordination with the Attorney
General and the heads of other Federal departments and agencies, as
appropriate, shall, for purposes of enhancing homeland security--
``(1) periodically review and recommend updates to criminal
laws to ensure that such laws are well suited to the evolving
risks of misuse of life sciences by terrorists and others; and
``(2) ensure that national biosecurity and biodefense
stakeholders at unique risk of exploitation have access to
guidance regarding actions that can reduce the risk of misuse
of life sciences by terrorists and others.
``(b) Report.--Not later than one year after the date of the
enactment of this section, and biannually thereafter, the Secretary, in
coordination with the Attorney General, shall submit to the appropriate
congressional committees the recommended updates to criminal laws, as
described in subsection (a)(1).
``SEC. 2110. EXPORT ENFORCEMENT FOR COUNTER-PROLIFERATION.
``(a) In General.--The Secretary, in coordination with the Secretary
of Commerce, the Secretary of Defense, the Attorney General, the
Secretary of State, the Director of National Intelligence, and the
heads of other appropriate Federal agencies shall--
``(1) conduct homeland security investigations and enforce
criminal violations of customs and export laws of the United
States related to military items, controlled commodities, and
sanctioned or embargoed countries to prevent individuals,
terrorist groups, foreign adversaries, and hostile nations
from--
``(A) illegally obtaining sensitive United States
technology and munitions; and
``(B) obtaining weapons of mass destruction
components, precursors, and delivery systems,
including--
``(i) United States military technical data,
hardware, small arms and defense services;
``(ii) dual-use technical data/source code
and commodities; and
``(iii) deemed exports; and
``(2) conduct industry outreach with manufacturers and
exporters of strategic commodities that may be targeted for
procurement by terrorist organizations and the countries that
support them as well as countries identified as weapons
proliferators, in a manner that acknowledges commerce and
trade, by--
``(A) educating companies and individuals on the
export laws of the United States;
``(B) discussing export licensing issues and
requirements;
``(C) identifying red flag indicators used in illegal
procurement;
``(D) identifying the government agencies responsible
for the licensing of export-controlled commodities and
technology; and
``(E) establishing and fostering relationships
whereby companies and individuals can report suspicious
contacts or attempts to violate the export laws of the
United States.
``(b) National Export Enforcement Coordination.--
``(1) Establishment; membership.--There is established in the
Department a unit responsible for national export enforcement
coordination that is managed by the Secretary. The unit shall
be composed of members who are representatives from the
Department, the Department of Commerce, the Department of
Defense, the Department of Energy, the Department of Justice,
the Department of State, the Intelligence Community, and other
Federal agencies as appropriate.
``(2) Responsibilities.--The unit shall carry out the
following responsibilities:
``(A) Coordinating law enforcement counter-
proliferation investigations and intelligence counter-
proliferation activities.
``(B) Addressing licensing inquiries, reviews,
requests, checks, and verifications.
``(C) Conducting outreach and providing training to
the export trade community.
``Subtitle B--Preparedness
``SEC. 2121. COMMUNICATION OF THREAT INFORMATION AND ALERTS.
``(a) Findings.--Congress makes the following findings:
``(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 and their agents.
``(b) Terrorism Threat Awareness.--
``(1) Terrorism threat awareness.--The Secretary, in
coordination with the heads of appropriate Federal agencies,
shall 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, for purposes of preparedness and collective
response to terrorism and for other purposes.
``(2) Threat bulletins.--
``(A) In general.--Consistent with the requirements
of paragraph (1), the Secretary shall, on a timely
basis, prepare unclassified terrorism-related threat
and risk assessments.
``(B) Requirements.--Each assessment required under
subparagraph (A) shall--
``(i) include guidance to the public for
preventing and responding to acts of terrorism;
and
``(ii) be made available on the Internet
website of the Department and other publicly
accessible Internet websites, communication
systems, and information networks.
``(3) Guidance to state, local, and tribal authorities.--The
Secretary--
``(A) acting through the Administrator of the Federal
Emergency Management Agency, 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 websites, communication systems, and information
networks in operation on the date of an assessment under this
subsection to satisfy the requirements of paragraph (2)(B)(ii).
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. 2122. INDIVIDUAL AND COMMUNITY PREPAREDNESS FOR WEAPONS OF MASS
DESTRUCTION.
``(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 weapons of mass
destruction and 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) disseminating the guidance developed under section 2151
to communities and individuals, as appropriate;
``(3) providing information and training materials in support
of individual and community preparedness efforts;
``(4) conducting individual and community preparedness
outreach efforts; and
``(5) such other actions as the Secretary determines
appropriate.
``(b) Coordination.--Where appropriate, the Secretary shall
coordinate with private sector and nongovernmental organizations to
promote individual and community preparedness and collective response
to weapons of mass destruction and 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)(3), the
Secretary shall give due regard to best practices based on the
experience of other countries and agencies and th expertise of academic
institutions and non-governmental organizations.
``Subtitle C--Detection
``SEC. 2131. NATIONAL BIOSURVEILLANCE STRATEGY.
``(a) Current State of Biosurveillance.--The Secretary shall examine
of the state of domestic and global biosurveillance.
``(b) Strategy for Biosurveillance.--The Secretary shall submit to
the appropriate congressional committees a national strategy for
biosurveillance.
``(c) Matters for Inclusion.--
``(1) In general.--In developing the strategy required under
subsection (b), the Secretary shall take into consideration--
``(A) the state of biosurveillance domestically and
internationally;
``(B) material threat assessments and determinations
developed by the Secretary in accordance with the
Project BioShield Act of 2004 (Public Law 108-276) and
the amendments made by that Act;
``(C) reports on global trends produced by the Office
of the Director of National Intelligence regarding the
biological threat;
``(D) information available in biosurveillance
systems and changes to information technology to allow
for the incorporation and integration of this
information;
``(E) Intelligence Community needs as articulated in
relevant intelligence strategies; and
``(F) costs associated with establishing and
maintaining the necessary infrastructure to integrate
biosurveillance systems.
``(2) Additional requirements.--This strategy required under
subsection (b) shall--
``(A) include a plan for advancing situational
awareness;
``(B) identify key elements of information to be
shared, critical sensitivities to be protected, and a
framework for enabling information exchange;
``(C) include a plan for fostering information
sharing between law enforcement, security,
intelligence, and national biosecurity and biodefense
stakeholders to identify potential threats, reduce
vulnerabilities and improve collective response
activities to and investigations of suspected
biological attacks; and
``(D) include strategic and implementation plans for
the National Biosurveillance Integration Center under
section 316.
``SEC. 2132. DETECTION OF BIOLOGICAL ATTACKS.
``(a) Program.--The Secretary shall carry out a program in the
Department to detect a biological attack or event. Through such
program, the Secretary shall--
``(1) deploy detectors to areas, based on risk, to indicate
the presence of biological agents;
``(2) provide information to participating laboratories for
their use in monitoring public health, and biological material
from these detectors to participating laboratories for testing;
``(3) provide information about the presence of biological
agents to public health and law enforcement personnel at all
levels of government; and
``(4) provide advanced planning tools, concepts of operations
(including alarm resolution protocols), and training exercises
for collective response to and recovery from biological
attacks.
``(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 filter testing protocols for
participating laboratories and coordination with appropriate
State, local, and tribal agencies;
``(2) determine, on an annual basis, whether plans for
biological detector capabilities and coverage sufficiently
protect the United States population; and
``(3) acting through the Under Secretary for Science and
Technology, and in consultation with the Director for the
Centers for Disease Control and Prevention, implement an assay
equivalency program for biological threat assays that--
``(A) may evaluate 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) may develop assay equivalency standards based
on the findings of the evaluation under subparagraph
(A);
``(C) will be updated as necessary;
``(D) shall require implementation of the standards
developed under subparagraph (B) for all Department
biological detection programs; and
``(E) shall make such standards available to support
all other Federal biological detection programs.
``(c) Contract Authority.--The Secretary is authorized to enter into
contracts with participating laboratories for--
``(1) the provision of laboratory services to test detector
filters 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.
``(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 Bioterrorism 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, the Federal
Bureau of Investigation and other law enforcement
agencies with responsibilities for investigating
biological incidents; and
``(C) supports threat agent characterization studies
and 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. 2133. RAPID BIOLOGICAL THREAT DETECTION AND IDENTIFICATION.
``(a) In General.--Notwithstanding section 302(4) the Secretary shall
require the Under Secretary for Science and Technology, in consultation
with the heads of other relevant operational components of the
Department, assess whether the development of screening capabilities
for biological agents, pandemic influenza, and other infectious
diseases should be undertaken by the Science and Technology Directorate
to support entry and exit screening at ports of entry and for other
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 rapidly screen incoming travelers at
ports of entry for biological agents, pandemic influenza, and other
infectious diseases.
``(c) Collaboration.--In developing methods under subsection (b), the
Secretary may collaborate with the heads of other Federal agencies, as
needed.
``SEC. 2134. ESTABLISHMENT OF THE SYSTEM ASSESSMENT AND VALIDATION FOR
EMERGENCY RESPONDERS (SAVER) PROGRAM.
``The Secretary, acting through the Under Secretary for Science and
Technology, 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 agents used in weapons of mass
destruction;
``(2) is supported by a network of scientists who perform the
assessment and validation activities;
``(3) provides results along with other relevant equipment
information to the emergency response provider community in an
operationally useful form;
``(4) provides information on equipment that falls within the
categories listed in the Department's authorized equipment
list;
``(5) provides information that enables decision-makers and
responders to better select, procure, use and maintain
emergency responder equipment; and
``(6) shares such information nationally with the emergency
response provider community.
``SEC. 2135. PAYMENT FOR BIOTERRORISM LABORATORY 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 to enter into contracts with the State and local public
health laboratories that compose the Laboratory Response Network for
Bioterrorism, and any other qualified laboratories, for the provision
of laboratory testing services on a fee-for-service basis or on a
prepayment or other similar basis.
``SEC. 2136. ESTABLISHMENT OF THE INTEGRATED CONSORTIUM OF LABORATORY
NETWORKS.
``(a) Establishment.--There is established in the Department an
Integrated Consortium of Laboratory Networks that is managed by the
Secretary.
``(b) Requirements.--The Integrated Consortium of Laboratory Networks
shall--
``(1) be composed of networks of laboratories capable of
integrated and coordinated response to and consequence
management of attacks from weapons of mass destruction, acts of
terrorism, and other incidents requiring laboratory response
capabilities;
``(2) be a coordinated and operational system of laboratory
networks that provide timely, high quality results for early
detection and effective consequence management of attacks from
weapons of mass destruction, acts of terrorism, and other
events requiring an integrated laboratory response;
``(3) serve as a system of laboratory networks that are
equipped to detect and respond quickly to attacks from weapons
of mass destruction and acts of terrorism;
``(4) provide limited containment and analysis in support of
the Department, the Federal Bureau of Investigation, and other
law enforcement agencies with responsibilities for
investigating incidents involving weapons of mass destruction
or their agents; and
``(5) support threat agent characterization studies and assay
evaluation, research and development.
``Subtitle D--Attribution
``SEC. 2141. BIOFORENSICS CAPABILITIES AND STRATEGY.
``(a) National Bioforensics Analysis Center.--There is established in
the Department a National Bioforensics Analysis Center which shall
serve as the lead Federal facility to--
``(1) provide definitive forensic examination of biothreat
agents and related evidence;
``(2) provide necessary biocontainment;
``(3) integrate bioforensics requirements for law
enforcement, national security, and homeland security;
``(4) provide bioforensics analysis in support of the
executive agencies with primary responsibilities for
preventing, deterring, responding to, attributing, and
recovering from biological attacks;
``(5) develop national bioforensics standards;
``(6) maintain the national bioforensics repository
collection as a reference collection of biological agents and
toxins for bioforensics comparisons and identifications; and
``(7) support threat agent characterization studies and
bioforensics assay evaluation research and development.
``(b) National Bioforensics Repository Collection.--
``(1) In general.--The National Bioforensics Analysis Center
shall maintain a distributed national bioforensics repository
collection.
``(2) Activities.--The national bioforensics repository
collection shall--
``(A) receive, store, and distribute biological
threat agents and toxins;
``(B) serve as a distributed reference collection for
comparative bioforensics identifications and
characterizations; and
``(C) support threat agent characterization studies
and the development of bioforensics assays, genomic
analyses, organic and inorganic chemical analyses,
electron microscopy analyses, and other relevant
assays, analyses, and tests.
``(3) Participation.--
``(A) In general.--The Secretary, the Attorney
General, the Secretary of Agriculture, the Secretary of
Defense, the Secretary of Energy, the Secretary of
Health and Human Services, the Director of National
Intelligence, and the head of any other appropriate
executive agency with a biological agent or toxin
collection that is useful for the bioforensics analysis
of biological attacks, performance of biological threat
agent identification and characterization studies, or
evaluation and development of bioforensics assays and
methods shall provide to the distributed national
bioforensics repository collection authenticated
replicate samples of, or information on, all relevant
biological strains and toxins, as determined by the
Secretary, in consultation with the head of the
executive agency possessing the agent or toxin.
``(B) Other biological agents and toxins.--The
Secretary shall require the contribution to the
national bioforensics repository collection of
authenticated replicate samples of, or information on,
all relevant biological strains and toxins, as
determined by the Secretary, from public and private
biological agent and toxin collections that were
collected or created with support from a Federal grant
or contract and that support the functions described in
paragraph (2).
``(4) Access.--The Secretary shall--
``(A) provide any executive agency that submits a
biological agent or toxin, or information on a
biological agent or toxin, to the national bioforensics
repository collection with access to the collection;
and
``(B) establish a mechanism to provide public and
private entities with access to agents or toxins in, or
information regarding, the national bioforensics
repository collection, as determined appropriate by the
Secretary, with appropriate protection of classified or
law enforcement sensitive information and intellectual
property rights.
``(5) Report.--
``(A) In general.--Not later than one year after the
date of the enactment of this section, and annually
thereafter, the Secretary, in consultation with the
Attorney General, the Secretary of Agriculture, the
Secretary of Defense, the Secretary of Energy, the
Secretary of Health and Human Services, the Director of
National Intelligence, and the head of any other
appropriate executive agency that participates in or
contributes agents, or toxins, or information to the
national bioforensics repository collection, shall
submit to the appropriate committees of Congress a
report regarding the national bioforensics repository
collection.
``(B) Contents.--The report submitted under
subparagraph (A) shall--
``(i) discuss the status of the establishment
of the distributed national bioforensics
repository collection;
``(ii) identify domestic and international
biological agent and toxin collections that
would prove useful in carrying out the
functions of the distributed national
bioforensics repository collection;
``(iii) examine any access or participation
issues affecting the establishment of the
distributed national bioforensics repository
collection or the ability to support
bioforensics analysis, threat agent
characterization studies, or bioforensics assay
evaluation, research, and development,
including--
``(I) intellectual property concerns;
``(II) access to collected or created
biological agent or toxin collections
funded by a Federal grant or contract;
``(III) costs incurred by domestic
and international biological agent and
toxin collections to access or
contribute biological agents or toxins
to the national bioforensics repository
collection; and
``(IV) access to the national
bioforensics repository collection by
public and private researchers to
support threat agent characterization
studies, bioforensics assay evaluation,
research, and development, and
biosecurity research and development;
and
``(iv) other issues determined appropriate.
``(c) National Bioforensics Strategy.--
``(1) In general.--The Secretary, in coordination with the
Attorney General, the Secretary of Agriculture, the Secretary
of Defense, the Secretary of Health and Human Services, the
Director of National Intelligence, and the head of any other
appropriate executive agency, as determined by the Secretary,
shall develop, coordinate, and maintain a national bioforensics
strategy.
``(2) Contents.--The national bioforensics strategy shall--
``(A) provide for a coordinated approach across all
executive agencies with responsibilities for--
``(i) conducting bioforensics examination of
biological threat agents and related evidence;
and
``(ii) generating bioforensics requirements
for law enforcement, national security, and
homeland security;
``(B) describe the roles and responsibilities of all
relevant executive agencies, including--
``(i) research to characterize threat agents;
``(ii) assay evaluation, research, and
development; and
``(iii) funding;
``(C) establish mechanisms, in coordination with
State, local, and tribal authorities, for coordinating
with public health, homeland security, and law
enforcement agencies for the collection or receipt,
transfer, or submission of bioforensics evidence for
analysis and its use; and
``(D) include--
``(i) guidance for collecting, processing,
and analyzing samples;
``(ii) requirements for reporting
bioforensics information to appropriate
agencies; and
``(iii) requirements for the distributed
national bioforensics repository collection.
``(3) Report.--Not later than one year after the date of the
enactment of this section, and biennially thereafter, the
Secretary, in consultation with the Attorney General, the
Secretary of Agriculture, the Secretary of Defense, the
Secretary of Health and Human Services, the Director of
National Intelligence, and the heads of other appropriate
agencies, as determined by the Secretary, shall submit to the
appropriate committees of Congress the national bioforensics
strategy.
``(d) Concept of Operations.--The Secretary, in coordination with the
Attorney General and the heads of any other appropriate Federal
agencies shall ensure the availability of a detailed concept of
operations for information sharing and all-source analysis to support
timely attribution of biological attacks.
``(e) Detailee Program.--Subject to the availability of
appropriations, the Secretary may implement a detailee program to
detail from governmental entities national biosecurity and biodefense
stakeholders with appropriate clearances, on a reimbursable basis, to
the National Bioforensics Analysis 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 National Bioforensics Analysis Center with
national biosecurity and biodefense stakeholders.
``(f) Research and Development.--The Secretary, in coordination with
the Attorney General and the heads of any other appropriate Federal
agencies, shall establish a national-level research and development
strategy and implementation plan to advance the field of bioforensics.
``(g) Definition of Bioforensics.--In this section, the term
`bioforensics' means the scientific discipline dedicated to analyzing
evidence from an attack with a biological weapon of mass destruction,
an act of bioterrorism, a biological agent- or toxin-based criminal
act, or the inadvertent release of a biological agent or toxin for
attribution purposes.
``SEC. 2142. FEDERAL LAW ENFORCEMENT TRAINING TO INVESTIGATE BIOLOGICAL
THREATS.
``The Secretary, in coordination with the Attorney General, the
Secretary of Agriculture, the Secretary of Health and Human Services,
and the heads of other appropriate Federal departments and agencies,
shall make available to law enforcement, public health, and security
personnel at the Federal Law Enforcement Training Center training on
recognizing and responding to situations involving potential biological
threats, including performing joint criminal and epidemiological
investigations, and shall--
``(1) ensure that tailored tactics, techniques, and
procedures are made available to law enforcement and security
personnel, including access to the tools needed to respond to
biological threats;
``(2) promote the use of simulation among Federal partners to
exercise capabilities, refine operational concepts, and
strengthen relationships across the Government; and
``(3) make training available that will ensure that law
enforcement, public health, and agricultural investigations of
biological threats are coordinated.
``Subtitle E--Response
``SEC. 2151. FIRST RESPONDER GUIDANCE CONCERNING WEAPONS OF MASS
DESTRUCTION ATTACKS.
``(a) Establishment of Voluntary Guidance.--Not later than one year
after the date of the enactment of this section, the Secretary shall--
``(1) develop for police, fire, emergency medical services,
emergency management, and public health personnel, voluntary
guidance for responding to a release of chemical, biological,
radiological, or nuclear material;
``(2) in developing the guidance under paragraph (1), review
the experiences of other countries and the expertise of
academic institutions and non-governmental organizations; and
``(3) make such guidance available to State, local, and
tribal authorities, nongovernmental organizations, the private
sector, and the public.
``(b) Contents.--The guidance developed under subsection (a)(1) shall
include--
``(1) protective action guidance for ensuring the security,
health, and safety of emergency response providers;
``(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 deal with 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) inventory existing relevant hazardous material response
guidance;
``(2) 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);
``(3) determine which entities should be consulted in
developing or revising the guidance;
``(4) prioritize, on a regular basis, guidance that should be
developed or revised; and
``(5) develop and disseminate the guidance in accordance with
the prioritization under paragraph (4).
``(e) Consultations.--The Secretary shall develop and revise the
guidance developed under subsection (a)(1), and the procedures required
under subsection (d), in consultation with--
``(1) the heads of other Federal departments and agencies, as
appropriate;
``(2) the National Advisory Council established under section
508;
``(3) the National Domestic Preparedness Consortium;
``(4) State, local, and tribal authorities; and
``(5) nongovernmental organizations and private industry.
``(f) Reporting Requirements.--Not later than 18 months after the
date of the enactment of this section and annually thereafter, the
Secretary shall submit to the appropriate congressional committees--
``(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) 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. 2152. INTEGRATED PLUME MODELING FOR COLLECTIVE RESPONSE.
``(a) Development.--
``(1) In general.--The Secretary shall acquire, use, and
disseminate integrated plume models to enable rapid response
activities following a chemical, biological, nuclear, or
radiological attack or event.
``(2) Scope.--The Secretary shall--
``(A) ensure the rapid development and distribution
of integrated plume models to appropriate officials of
the Federal Government and State, local, and tribal
authorities to enable immediate response to a chemical,
biological, or radiological 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 the development and dissemination
of integrated plume models are assessed during
exercises administered by the Department; 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 Department of Homeland Security
Lessons Learned Information Sharing system.
``(b) Report.--Not later than one year after the date of enactment of
this section, and annually thereafter, the Secretary shall submit to
the appropriate congressional committees a report regarding--
``(1) the acquisition, use, and dissemination of integrated
plume models under this section;
``(2) lessons learned from assessing the development and
dissemination of integrated plume models during exercises
administered by the Department; and
``(3) recommendations for improving integrated plume models,
as appropriate.
``(c) 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.
``Subtitle F--Recovery
``SEC. 2161. RECOVERY AND RESTORATION FROM A BIOLOGICAL ATTACK OR
INCIDENT GUIDANCE.
``(a) Establishment of Guidance.--Not later than one year after the
date of the enactment of this section, the Secretary, in coordination
with the Administrator of the Environmental Protection Agency and in
consultation with the Director of the Occupational Safety and Health
Agency, and the Director of the National Institute for Occupational
Safety and Health, 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 affected by a biological
attack or event.
``(b) Contents.--The guidance developed under subsection (a) shall
include--
``(1) acceptable levels of growth of the organism in post-
remediation area samples from affected sites;
``(2) standards for effective clean-up of affected sites;
``(3) standards for safe post-event occupancy of affected
sites;
``(4) requirements to ensure that the decontamination
procedures for responding organizations do not conflict;
``(5) requirements that each responding organization uses a
uniform system for tracking costs and performance of clean-up
contractors;
``(6) levels of personal protection equipment;
``(7) maintenance of negative air pressure in buildings;
``(8) standards for proper selection and use of personal
protective equipment;
``(9) air sampling procedures; and
``(10) how to develop occupational health and safety plans
that are appropriate for the specific risk to responder health.
``(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) inventory existing relevant guidance;
``(2) enable the public to submit recommendations of areas in
which guidance is needed;
``(3) determine which entities should be consulted in
developing or revising the guidance;
``(4) prioritize, on a regular basis, guidance that should be
developed or revised; and
``(5) develop and disseminate the guidance in accordance with
the prioritization under paragraph (4).
``(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, as
appropriate;
``(2) State, local, and tribal authorities; and
``(3) nongovernmental organizations and private industry.
``(f) Report.--Not later than one 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) were 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.''.
(b) Clerical Amendments.--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 and Deterrence
``Sec. 2101. Weapons of Mass Destruction Intelligence and
Information Sharing Unit.
``Sec. 2102. Information sharing and collaboration for
biosecurity and biodefense.
``Sec. 2103. Bioterrorism risk assessments.
``Sec. 2104. Radiological materials security.
``Sec. 2105. Enhanced biosecurity measures.
``Sec. 2106. Tier I Material Threat Agent locations.
``Sec. 2107. High containment biological laboratory security
grants.
``Sec. 2108. Laboratory biosecurity information sharing.
``Sec. 2109. Periodic homeland security review of criminal
statutes.
``Sec. 2110. Export enforcement for counter-proliferation.
``Subtitle B--Preparedness
``Sec. 2121. Communication of threat information and alerts.
``Sec. 2122. Individual and community preparedness for weapons
of mass destruction.
``Subtitle C--Detection
``Sec. 2131. National biosurveillance strategy.
``Sec. 2132. Detection of biological attacks.
``Sec. 2133. Rapid biological threat detection and
identification.
``Sec. 2134. Establishment of the system assessment and
validation for emergency responders (SAVER)
program.
``Sec. 2135. Payment for bioterrorism laboratory services.
``Sec. 2136. Establishment of the integrated consortium of
laboratory networks.
``Subtitle D--Attribution
``Sec. 2141. Bioforensics capabilities and strategy.
``Sec. 2142. Federal law enforcement training to investigate
biological threats.
``Subtitle E--Response
``Sec. 2151. First responder guidance concerning weapons of
mass destruction attacks.
``Sec. 2152. Integrated plume modeling for collective response.
``Subtitle F--Recovery
``Sec. 2161. Recovery and restoration from a biological attack
or incident guidance.
SEC. 202. 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 `weapon of mass destruction' has the meaning
given that term in section 1403(1) fo the Defense Against
Weapons of Mass Destruction Act of 1996 (50 U.S.C. 2302).
``(20) 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)).
``(21) 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, deter, prepare for,
detect, attribute, respond, 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.
``(22) The term `Tier I Material Threat Agent' means a
substance so designated under section 351A(a)(2) of the Public
Health Service Act or section 212(a)(2) of the Agricultural
Bioterrorism Protection Act of 2002.''.
SEC. 203. DUAL-USE TERRORIST RISKS FROM SYNTHETIC GENOMICS.
(a) Sense of Congress.--It is the sense of Congress that the field of
synthetic genomics has the potential to facilitate enormous gains in
fundamental discovery and biotechnological applications, but it also
has inherent dual-use homeland security risks that must be managed.
(b) Requirement.--Not later than one year after the date of enactment
of this Act, the Secretary of Homeland Security, acting through the
Under Secretary of Homeland Security for Science and Technology, shall
examine and report to the appropriate congressional committees on the
homeland security implications of the dual-use nature of synthetic
genomics, and if the Under Secretary determines that such research is
appropriate, may conduct research in that area, 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 the
study.
SEC. 204. DISSEMINATION OF INFORMATION ANALYZED BY THE DEPARTMENT TO
STATE, LOCAL, TRIBAL, AND PRIVATE ENTITIES WITH
RESPONSIBILITIES RELATING TO HOMELAND SECURITY.
(a) Responsibilities of the Secretary.--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.''.
(b) Report.--Not later than one year after the date of the enactment
of this Act, the Secretary of Homeland Security shall submit to the
appropriate congressional committees a report on the implementation of
this section.
SEC. 205. NATIONAL BIOSURVEILLANCE INTEGRATION CENTER (NBIC).
Section 316 of the Homeland Security Act of 2002 (6 U.S.C. 195b) is
amended--
(1) in subsection (a), by striking ``an office or directorate
of the Department'' and all that follows through the period at
the end and inserting the following: ``the Office of
Intelligence and Analysis.'';
(2) in subsection (d)(2)(B)--
(A) by inserting ``and disseminate'' after
``integrate''; and
(B) by inserting ``, including information and
intelligence generated elsewhere within the Office of
Intelligence and Analysis and the Department,'' after
``information'' ;
(3) in subsection (e)(1), by striking subparagraph (A) and
inserting the following new subparagraph (A):
``(A) integrate biosurveillance information into the
NBIC, with the goal of promoting information sharing
between Federal, State, local, and tribal authorities
to detect biological attacks and events of homeland
concern;'';
(4) by amending paragraph (2) of subsection (f) to read as
follows:
``(2) Detail of personnel.--The head of a participating
Federal department or agency shall 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.'';
and
(5) by redesignating subsection (j) as subsection (k) and
inserting after subsection (i) the following new subsection
(j):
``(j) Annual Report.--Not later than one year after the date of the
enactment of the WMD Prevention and Preparedness Act of 2010 and
annually thereafter, the Secretary shall submit to the appropriate
congressional committees a report on--
``(1) the status of operations at the National
Biosurveillance Integration Center of the Department under
section 316;
``(2) efforts by the Office of Intelligence and Analysis to
take responsibility for the National Biosurveillance
Integration Center; and
``(3) efforts to integrate the biosurveillance efforts of
Federal, State, local, and tribal authorities.''.
SEC. 206. REPORT ON ESTABLISHMENT OF THE SYSTEM ASSESSMENT AND
VALIDATION FOR EMERGENCY RESPONDERS (SAVER)
PROGRAM.
Not later than one year after the date of the enactment of this Act,
the Secretary of Homeland Security shall submit to the appropriate
congressional committees a report on the SAVER Program under section
2134 of the Homeland Security Act of 2002, as added by section 201.
SEC. 207. NATIONAL ACADEMY OF SCIENCES STUDY OF FORENSIC SCIENCE IN
HOMELAND SECURITY.
(a) Study.--Not later than 90 days after the date of the enactment of
this Act, the Secretary of Homeland Security, acting through the Under
Secretary of Homeland Security for Science and Technology, shall seek
to enter into an agreement with the National Academy of Sciences to--
(1) conduct a study, building on previous studies conducted
by the National Academy of Sciences, on the role of forensic
science in homeland security; and
(2) issue recommendations to enhance this homeland security
capability to investigate attacks from weapons of mass
destruction, terrorist incidents, and other crimes investigated
by the Department.
(b) Report.--Not later than two years after the date of the enactment
of this Act, the Secretary shall submit to the appropriate
congressional committees a report containing the results of the
National Academy of Sciences study required under subsection (a),
together with any recommendations of the Secretary related thereto.
(c) Authorization of Appropriations.--There is authorized to be
appropriated to the Department, for fiscal year 2011, $1,000,000 to
carry out this section.
SEC. 208. HARMONIZATION OF REGULATIONS.
(a) Regulations Under Public Health Service Act.--Not later than one
year after the Secretary of Homeland Security promulgates regulations
or amendments thereto to carry out section 2104 of the Homeland
Security Act of 2002, as added by section 201, the Secretary of Health
and Human Services shall amend regulations promulgated under the Select
Agent Program under section 351A(b)(1) of the Public Health Service Act
(42 U.S.C. 262a(b)(1)) to ensure that such regulations are not
redundant or are not in conflict with the regulations promulgated by
the Secretary under such section 2104.
(b) Regulations Under Agriculture Bioterrorism Protection Act of
2002.--Not later than one year after the Secretary of Homeland Security
promulgates regulations or amendments thereto pursuant to such section
2104, the Secretary of Agriculture shall amend regulations promulgated
under the Select Agent Program under section 212(b)(1) of the
Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401(b)(1))
to ensure that such regulations are not redundant or are not in
conflict with the regulations promulgated by the Secretary under such
section 2104.
SEC. 209. COMMUNICATIONS PLANNING FOR WEAPONS OF MASS DESTRUCTION
INFORMATION DISSEMINATION.
(a) Communications Plans Required.--Section 653 of the Post-Katrina
Emergency Management Reform Act of 2006 (6 U.S.C. 753) is amended--
(1) in subsection (a)(4), by inserting after ``man-made
disasters'' the following ``, and a communications plan
described in subsection (f)''; and
(2) by adding at the end the following new subsection:
``(f) Communications Plan.--
``(1) In general.--A communications plan developed under
subsection (a)(4) shall be designed to provide information to
the public related to preventing, preparing for, and responding
to attacks from weapons of mass destruction and acts of
terrorism;
``(2) Consultation.--As appropriate, the Administrator shall
consult with State, local, and tribal authorities and
coordinate with other Federal departments and agencies in
developing communications plans under paragraph (1).
``(3) Pre-scripted messages and message templates.--
``(A) In general.--The Administrator shall develop
and disseminate pre-scripted messages and message
templates to be provided to 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 an attack from a weapon of mass
destruction or terrorist incident, 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;
and
``(iii) be designed to provide accurate,
essential, and appropriate information and
instructions to emergency response providers
and medical personnel responding to an
incident.
``(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; and
``(ii) to individuals with disabilities or
other special needs and individuals with
limited English proficiency.
``(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 such pre-
scripted messages or message templates into exercises
conducted under the National Exercise Program described
in section 648 of the Post-Katrina Emergency Management
Reform Act of 2006 (6 U.S.C. 748).''.
(b) Report.--Not later than one year after the date of the enactment
of this Act, the Administrator shall submit to the appropriate
congressional committees the communications plans required to be
developed under the amendments made by subsection (a), 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.
SEC. 210. ENVIRONMENTAL RECOVERY FROM CHEMICAL, BIOLOGICAL,
RADIOLOGICAL, AND NUCLEAR ATTACKS.
(a) In General.--To facilitate environmental 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 Administrator of the
Environmental Protection Agency, in coordination with the Administrator
of the Federal Emergency Management Agency, shall assess capability
gaps in environmental recovery preparedness and provide guidance to
State, local, and tribal authorities.
(b) Requirements.--In carrying out subsection (a), the Administrator
of the Environmental Protection Agency shall--
(1) assess capability gaps in the Nation's ability to recover
from chemical, biological, radiological, and nuclear attacks or
incidents, with specific attention to--
(A) decontamination standards, gaps in such
standards, and recommendations for research to minimize
these gaps;
(B) environmental remediation methods; and
(C) such other components as determined by the
Secretary;
(2) disseminate guidance to State, local, and tribal
authorities that conforms to the goals of the National Disaster
Recovery Strategy as required in Section 682 of the Department
of Homeland Security Appropriations Act, 2007 (Public Law 109-
295; 6 U.S.C. 771) regarding how to conduct environmental
remediation of contaminated areas, including--
(A) clarification of Federal roles and
responsibilities for assisting State, local, and tribal
authorities; and
(B) such other guidance as determined by the
Secretary; and
(3) develop exercises in consultation with State, local, and
tribal authorities and other appropriate Federal agencies, to
enhance collective response to and recovery from chemical,
biological, radiological and nuclear attacks and incidents,
including exercises that address analysis, environmental
cleanup methods, and decontamination standards.
(c) Report.--Not later than one year after the date of the enactment
of this Act, the Administrator of the Environmental Protection Agency
shall submit to the appropriate congressional committees a report on
the Administrator's assessment under section 2162 of the Homeland
Security Act of 2002, as added by section 201.
SEC. 211. UNIVERSITY-BASED CENTERS FOR HOMELAND SECURITY CRITERIA FOR
DESIGNATION.
Section 308(b)(2)(B)(iii) of the Homeland Security Act of 2002 (6
U.S.C. 188(b)(2)(B)(iii)) is amended by inserting before the period at
the end the following ``, including medical readiness training and
research, and community resiliency for public health and healthcare
critical infrastructure''.
TITLE III--PUBLIC HEALTH MATTERS
SEC. 301. 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.--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.
``(c) Coordination.--Where appropriate, the Secretary shall
coordinate with State, local, and tribal authorities, private sector,
and nongovernmental organizations on the National Medical
Countermeasures Dispensing Strategy.
``(d) Report.--Not later than one year after the date of the
enactment of this section, the Secretary, in coordination with the
Secretary of Homeland Security, shall submit the National Medical
Countermeasures Dispensing Strategy to the appropriate congressional
committees.''.
SEC. 302. MATERIAL THREAT ASSESSMENTS AND DETERMINATIONS.
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) in clause (ii), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(iii) review and reassess determinations
under clause (ii) to determine whether agents
continue to present a material threat against
the United States population sufficient to
affect national security and homeland
security.''.
SEC. 303. 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, 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. In carrying out the review
under this section, the Secretary shall consider--
(1) material threat assessments and determinations conducted
by the Department of Homeland Security;
(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 domestic vaccine and antimicrobials
to dispense to the public, on a voluntary basis, in
anticipation of a biological attack; and
(4) making surplus or expiring domestic vaccine and
antimicrobials available to State, local, and tribal emergency
responders, including health care responders, on a voluntary
basis.
(b) Report.--Not later than one year after the date of the enactment
of this Act, the Secretary of Health and Human Services shall submit to
the appropriate congressional committees a report 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. 304. DESIGNATION OF TIER 1 MATERIAL THREAT AGENTS.
(a) Public Health Service Act.--Section 351A of the Public Health
Service Act (42 U.S.C. 262a) is amended in subsection (a)--
(1) by redesignating paragraph (2) as paragraph (3);
(2) by inserting after paragraph (1) the following:
``(2) Tier i material threat agents.--
``(A) Designation of tier i: material threat
agents.--Not later than 1 year after the date of the
enactment of this paragraph, the Secretary, in
coordination with the Secretary of Homeland Security
and other Federal officials as appropriate, shall by
regulation designate as `Tier I Material Threat Agents'
those agents and toxins--
``(i) that--
``(I) are determined by the Secretary
of Homeland Security under section
319F-2(c)(2) to present a material
threat against the United States
population sufficient to affect
national security; and
``(II) are determined to warrant
designation after applying the criteria
in subparagraph (B); or
``(ii) that clearly present a material threat
to the Nation as otherwise determined by the
Secretary or the Secretary of Homeland
Security.
``(B) Criteria.--In determining whether to designate
an agent or toxin as a Tier I Material Threat Agent
under subparagraph (A)(i), the Secretary, in
coordination with the Secretary of Homeland Security,
shall consider--
``(i) whether the agent or toxin can be used
effectively in a biological attack;
``(ii) information available from any
biological or bioterrorism risk assessments
conducted by the Department of Homeland
Security and relevant assessments by other
agencies; and
``(iii) such other criteria and information
as the Secretary, in coordination with the
Secretary of Homeland Security, determines
appropriate and relevant.
``(C) Inclusion of agents and toxins not previously
listed.--All agents or toxins designated by the
Secretary as Tier I Material Threat Agents shall be
included on the list maintained by the Secretary
pursuant to paragraph (1).
``(D) Evaluation of tier i material threat agents.--
The Secretary, in coordination with the Secretary of
Homeland Security, shall--
``(i) on an ongoing basis, consider the
inclusion of additional agents or toxins on the
list of Tier I Material Threat Agents, as
appropriate; and
``(ii) at least biennially, review the list
of Tier I Material Threat agents to determine
whether any agents or toxins should be removed
from the list.''; and
(3) in paragraph (3), as so redesignated--
(A) by striking ``list under paragraph (1)'' and
inserting ``lists under paragraphs (1) and (2)''; and
(B) by striking ``revise the list'' and inserting
``revise the lists''.
(b) Agricultural Bioterrorism Protection Act of 2002.--Section 212(a)
of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C.
8401(a)) is amended--
(1) by redesignating paragraph (2) as paragraph (3);
(2) by inserting after paragraph (1) the following:
``(2) Tier i material threat agents.--
``(A) Designation of tier i: material threat
agents.--Not later than one year after the date of the
enactment of this paragraph, the Secretary, in
coordination with the Secretary of Homeland Security,
the Secretary of Health and Human Services, and other
Federal officials as appropriate, shall by regulation
designate as `Tier I Material Threat Agents' those
agents and toxins--
``(i) that--
``(I) are determined by the Secretary
of Homeland Security under section
319F-2(c)(2) of the Public Health
Service Act to present a material
threat against the United States
population sufficient to affect
national security; and
``(II) are determined to warrant
designation after applying the criteria
in subparagraph (B); or
``(ii) that clearly present a material threat
to the Nation as otherwise determined by the
Secretary or the Secretary of Homeland
Security.
``(B) Criteria.--In determining whether to designate
an agent or toxin as a Tier I Material Threat Agent
under subparagraph (A)(i), the Secretary, in
coordination with the Secretary of Homeland Security,
shall consider--
``(i) whether the agent or toxin can be used
effectively in a biological attack;
``(ii) information available from any
biological or bioterrorism risk assessments
conducted by the Department of Homeland
Security and relevant assessments by other
agencies; and
``(iii) such other criteria and information
that the Secretary, in coordination with the
Secretary of Homeland Security, determines
appropriate and relevant.
``(C) Inclusion of agents and toxins not previously
listed.--All agents or toxins designated by the
Secretary as Tier 1 Material Threat Agents shall be
included on the list maintained by the Secretary
pursuant to paragraph (1).
``(D) Evaluation of tier i material threat agents.--
The Secretary, in coordination with the Secretary of
Homeland Security, shall--
``(i) on an ongoing basis, consider the
inclusion of additional agents or toxins on the
list of Tier I Material Threat Agents, as
appropriate; and
``(ii) at least biennially, review the list
of Tier I Material Threat agents to determine
whether any agents or toxins should be removed
from the list.''; and
(3) in paragraph (3), as so redesignated--
(A) by striking ``list under paragraph (1)'' and
inserting ``lists under paragraphs (1) and (2)''; and
(B) by striking ``revise the list'' and inserting
``revise the lists''.
SEC. 305. 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 coordinate 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. 306. BIOTECHNOLOGY RESEARCH, DEVELOPMENT, AND PROCUREMENT.
Title III of the Public Health Service Act is amended by inserting
after section 319M (42 U.S.C. 247d-f) the following:
``SEC. 319N. BIOTECHNOLOGY RESEARCH, DEVELOPMENT, AND PROCUREMENT.
``(a) In General.--The Secretary shall develop a comprehensive
research, development, and acquisition process to counter the
biological threat that employs the inherent functions, capabilities,
authorities, and responsibilities of NIH, BARDA, and Project BioShield.
The process shall--
``(1) assign NIH responsibility for research and development
of technologies that range in development from basic principles
observed and reported up to model or prototype demonstration in
a relevant environment;
``(2) assign BARDA responsibility for research and
development of technologies that range in development from
model or prototype demonstration in a relevant environment up
to a system qualified for application through successful test
and demonstration;
``(3) assign Project BioShield responsibility for procurement
of technologies that--
``(A) are qualified for application through
successful test and demonstration; and
``(B) meet the minimum statutory requirements for
emergency use authorization in section 564 of the
Federal Food, Drug, and Cosmetic Act; and
``(4) include a formal agreement among NIH, BARDA, and
Project BioShield that--
``(A) identifies the need for any specific biological
countermeasure, derived from information developed
under section 319F-2;
``(B) identifies the current technology readiness
level of the countermeasure; and
``(C) requires the development of the biological
countermeasure from the current technology readiness
level through the procurement of the countermeasure in
accordance with paragraph (3).
``(b) Responsibility of NIH.--For countermeasures identified under
subsection (a)(4)(A) that have a level of development from basic
principles observed and reported up to model or prototype demonstration
in a relevant environment, the Director of NIH shall conduct research
and development until the Director certifies to the Secretary of Health
and Human Services that--
``(1) the countermeasure has completed model or prototype
demonstration in a relevant environment; or
``(2) the Director does not believe that completion of model
or prototype demonstration in a relevant environment is
reasonably achievable.
``(c) Responsibility of BARDA.--For countermeasures identified under
subsection (a)(4)(A) that have a level of development of model or
prototype demonstration in a relevant environment, including but not
limited to those countermeasures certified to have that level of
development by the Director of NIH, the Director of BARDA shall conduct
research and development until the Director of BARDA certifies to the
Secretary of Health and Human Services that--
``(1) the countermeasure has qualified for application
through successful test and demonstration; or
``(2) the Director does not believe that qualification for
application through successful test and demonstration is
reasonably achievable.
``(d) Responsibility of Project BioShield.--For countermeasures
identified under subsection (a)(4)(A) that are qualified for
application through successful test and demonstration, including but
not limited to those countermeasures certified to have qualified for
application through successful test and demonstration by the Director
of BARDA, the Assistant Secretary of Health and Human Services for
Preparedness and Response shall use the Project BioShield special
reserve fund to may procure the countermeasure if the countermeasure
meets the requirements for emergency use authorization described in
subsection (a)(3)(B).
``(e) No Requirement for Food and Drug Administration General Use
Approval.--The Secretary shall ensure that the Directors of NIH and
BARDA and the Assistant Secretary of Health and Human Services for
Preparedness and Response do not discontinue any research, development,
or procurement of a countermeasure identified under subsection
(a)(4)(A) because the Food and Drug Administration has not, or decides
against, approving or licensing the countermeasure for general use
under chapter V of the Federal Food, Drug, and Cosmetic Act or section
351 of this Act, as applicable.
``(f) Innovation.--The Secretary shall require the Directors of NIH
and BARDA and the Assistant Secretary of Health and Human Services for
Preparedness and Response to aggressively pursue innovative research,
development, and procurement of each countermeasure identified under
subsection (a)(4)(A).
``(g) Definitions.--In this section:
``(1) The term `BARDA' means the he Biomedical Advanced
Research and Development Authority established under section
319L(c).
``(2) The term `NIH' means the National Institutes of Health.
``(3) The term `Project Bioshield' means the Federal medical
countermeasure procurement program established by Public Law
108-276.''.
TITLE IV--FOREIGN RELATIONS MATTERS
SEC. 401. INTERNATIONAL COLLABORATION AND INFORMATION SHARING RELATING
TO BIOSECURITY.
The Secretary of State, in coordination 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--
(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. 402. INTERNATIONAL ENGAGEMENT TO ENHANCE BIODEFENSE AND
BIOSECURITY.
The Secretary of State, in coordination and consultation with the
Secretary of Homeland Security, and the heads other 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. 403. 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 and deterrence;
(C) detection;
(D) regional stockpiling of medical countermeasures,
including considerations of--
(i) security of the stockpile;
(ii) delivery planning; and
(iii) legal dimensions of and obstacles to
implementing such an architecture;
(E) attribution;
(F) response;
(G) other elements that should be a component of such
an architecture; and
(H) 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 Strategy for
Countering Biological Threats 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 United States Agency for International Development;
(8) the Director of National Intelligence;
(9) other Federal Departments and agencies, as determined
appropriate by the Secretary; and
(10) other national biosecurity and biodefense stakeholders,
including private sector, including the pharmaceutical industry
and the biological laboratory community, as determined
appropriate by the Secretary.
(d) Report.--Not later than 18 months 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. 404. 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. 5498, the WMD Prevention and Preparedness Act of 2010,
was introduced by Representatives Bill Pascrell (D-NJ) and
Peter T. King (R-NY) on June 10, 2010. The purpose of H.R. 5498
is to enhance homeland security by improving efforts to
prevent, deter, prepare for, detect, attribute, respond to, and
recover from attacks with weapons of mass destruction (WMD).
Background and Need for Legislation
Title 18 of the ``Implementing Recommendations of the 9/11
Commission Act of 2007'' (P.L. 110-53; Aug. 3, 2007) authorized
the establishment of a bipartisan commission to study the
threat that the proliferation of WMD poses to our country.
Congress directed the independent, bipartisan Commission for
the Prevention of WMD Proliferation and Terrorism (the
Commission) to address the WMD threat in general and the
nuclear threat specifically.
The Commission, led by former Senator Bob Graham (Chair)
and Former Senator Jim Talent (Vice-Chair), was charged with:
(1) Assessing Federal activities, initiatives, and programs to
prevent WMD proliferation and terrorism; and (2) providing a
clear and comprehensive strategy and concrete recommendations
to address the WMD threat. The Commission decided to focus on
biological and nuclear threats--the two WMD threats that they
felt had the greatest potential to kill the largest number of
people.
The Commission submitted a report entitled ``World at
Risk'' to the President and Congress in December 2008. The
Commission concluded that: (1) 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; (2) terrorists are more likely to obtain and use a
biological weapon than a nuclear weapon; and (3) 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'' 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.''
Former Senators Graham and Talent testified before the Full
Committee on Homeland Security on April 21, 2010. At this
hearing, 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 had 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, and the Homeland Security and Governmental Affairs
Committee in the Senate.
Enactment of H.R. 5498 is needed to better address the gaps
identified by the Commission and to better organize efforts by
the public and private sectors to prevent, deter, prepare for,
detect, attribute, 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.
This approach includes: (1) strengthening intelligence and
bioforensics; (2) enhancing security at laboratories with the
most dangerous pathogens; (3) reviewing national policies that
govern medical countermeasures and vaccinations; (4) enhancing
international collaboration against the WMD threat; and (5)
improving environmental recovery from a WMD attack.
Hearings
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.
Previously, 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 Senator Bob Graham, who chaired the
Commission for the Prevention of WMD Proliferation and
Terrorism and from former Senator Jim Talent, who was Vice-
Chairman of the Commission for the Prevention of WMD
Proliferation and Terrorism. Additionally, the following
Committee on Homeland Security hearings informed H.R. 5498:
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 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 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 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.
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 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.
Committee Consideration
The Committee met on June 23, 2010, to consider H.R. 5498,
and ordered the measure to be reported to the House with a
favorable recommendation, amended, by a recorded vote of 26
yeas and 0 nays (Roll Call Vote No. 24). The Committee took the
following actions:
The Committee adopted H.R. 5498, as amended, by voice
vote.
The following amendments were offered:
An Amendment in the Nature of a Substitute offered by Mr.
Thompson to H.R. 5498, (#1); was AGREED TO by voice vote.
A unanimous consent request by Mr. Thompson that all of
the amendments listed on the roster be adopted; was AGREED TO
without objection.
An Amendment offered by Ms. Richardson to the Amendment in
the Nature of a Substitute to H.R. 5498, (#1A),
Page 31, after line 14, insert the following:
``(c) Best Practices._In compiling guidance for individual
and community preparedness in order to carry out subsection
(a)(3), the Secretary shall give due regard to best practices
based on the experience of other countries and agencies and the
expertise of academic institutions and non-governmental
organizations.''; was AGREED TO by unanimous consent.
An Amendment offered by Ms. Richardson to the Amendment in
the Nature of a Substitute to H.R. 5498, (#1B).
Page 50, line 14, strike ``and''.
Page 50, after line 14, insert the following:
``(2) in developing the guidance under paragraph (1),
review the experiences of other countries and the expertise of
academic institutions and non-governmental organizations,
and''; was AGREED TO by unanimous consent.
An Amendment offered by Mr. Austria to the Amendment in the
Nature of a Substitute to H.R. 5498, (#1C); Page 51, line 19,
after ``first responder'' insert the following: ``and first
provider''.
Page 52, after line 13, insert the following: ``the
National Domestic Preparedness Consortium;''.
Page 52, line 14, strike ``(3)'' and insert ``(4)''.
Page 53, line 15, strike ``(4)'' and insert ``(5)''.; was
AGREED TO by unanimous consent.
An Amendment offered by Mr. Austria to the Amendment in the
Nature of a Substitute to H.R. 5498, (#1D), Page 73, after line
7, insert a new section entitled ``Sec. 211. University-Based
Centers for Homeland Security Criteria for Designation.''; was
AGREED TO by unanimous consent.
An Amendment offered by Ms. Clarke to the Amendment in the
Nature of a Substitute to H.R. 5498, (#1E), Page 16, after line
14, insert a new section entitled ``Sec. 2104. Radiological
Materials Security.''; was AGREED TO by unanimous consent.
An Amendment offered by Ms. Clarke to the Amendment in the
Nature of a Substitute to H.R. 5498, (#1F), Page 56, line 1,
after ``outdoor areas'' insert the following: ``, including
subways and other mass transportation facilities,''.; was
AGREED TO by unanimous consent.
An Amendment offered by Mr. Green to the Amendment in the
Nature of a Substitute to H.R. 5498, (#1G), Page 48, after line
16, insert a new subparagraph entitled ``(e) Detailee
Program.''
Page 48, line 17, strike ``(e)'' and insert ``(f)''.
Page 48, line 23, strike ``(f)'' and insert ``(g)''.; was
AGREED TO by unanimous consent.
An Amendment offered by Mr. Owens to the Amendment in the
Nature of a Substitute to H.R. 5498, (#1H), In the proposed
section 2121(b)(4) of the Homeland Security Act of 2002, as
proposed to be inserted by section 201, add at the end the
following: ``The Secretary shall provide guidance on how State
and 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.''; was AGREED
TO by unanimous consent.
An Amendment offered by Mr. Cuellar to the Amendment in the
Nature of a Substitute to H.R. 5498, (#1I), Page 22, line 12,
strike ``The'' and insert ``At the request of the Secretary,
the''.; was AGREED TO by unanimous consent.
An Amendment offered by Mr. Cuellar to the Amendment in the
Nature of a Substitute to H.R. 5498, (#1J), Page 26, line 11,
after ``proliferators,'' insert the following: ``in a manner
that acknowledges commerce and trade,''.; was AGREED TO by
unanimous consent.
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.
The Committee on Homeland Security considered H.R. 5498 on
June 23, 2010, and ordered the measure reported to the House
with a favorable recommendation, as amended, by a recorded vote
of 26 yeas and 0 nays (Roll Call Vote No. 24).The vote was as
follows:
YEAS NAYS
Mr. Thompson
Ms. Sanchez
Ms. Harman
Ms. Norton
Mr. Cuellar
Mr. Carney
Ms. Clarke
Ms. Richardson
Mrs. Kirkpatrick
Mr. Pascrell
Mr. Cleaver
Mr. Green
Mr. Himes
Ms. Kilroy
Ms. Titus
Mr. Owens
Mr. King
Mr. Lungren
Mr. Rogers
Mr. McCaul
Mr. Dent
Mr. Bilirakis
Mr. Broun
Mr. Cao
Mr. Austria
Mr. Graves
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.
5498, the WMD Prevention and Preparedness Act of 2010, 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.
U.S. Congress,
Congressional Budget Office,
Washington, DC, October 26, 2010.
Hon. Bennie G. Thompson,
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. 5498, the WMD
Prevention and Preparedness Act of 2010.
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. 5498--WMD Prevention and Preparedness Act of 2010
Summary: CBO estimates that H.R. 5498 would authorize the
appropriation of $565 million over the 2011-2015 period for
programs in the Department of Homeland Security (DHS), the
Department of Health and Human Services (HHS), and other
agencies to address the threat of weapons of mass destruction.
Assuming appropriation of the necessary amounts, CBO
estimates that implementing H.R. 5498 would cost $455 million
over the 2011-2015 period. We also estimate that enacting the
bill would reduce direct spending by $58 million over the 2011-
2015 period and by $23 million over the 2011-2020 period. In
addition, enacting, the bill could have an insignificant effect
on revenues. Because H.R. 5498 would affect direct spending and
revenues, pay-as-you-go procedures apply.
H.R. 5498 would impose intergovernmental and private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
because it would require public and private laboratories to
comply with new security standards. Because the number of
laboratories that would be affected and the types of security
measures would depend on future regulations, CBO cannot
estimate the costs of the mandates. Consequently, CBO cannot
determine whether those costs would exceed the annual
thresholds for intergovernmental or private-sector mandates
($70 million and $141 million in 2010, respectively, adjusted
annually for inflation).
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 5498 is shown in the following table.
The costs of this legislation fall within budget functions 150
(international affairs), 300 (natural resources and
environment), 350 (agriculture), 450 (community and regional
development), 550 (health), and 750 (administration of justice)
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------
2011 2012 2013 2014 2015 2011-2015
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
DHS Programs:
Estimated Authorization Level....................... 79 75 75 25 25 279
Estimated Outlays................................... 25 35 47 55 57 219
HHS Programs:
Estimated Authorization Level....................... 46 54 55 56 57 268
Estimated Outlays................................... 17 42 51 53 56 219
Other Programs:
Estimated Authorization Level....................... 10 2 2 2 2 18
Estimated Outlays................................... 9 2 2 2 2 17
Total Changes:
Estimated Authorization Level....................... 135 131 132 83 84 565
Estimated Outlays................................... 51 79 100 110 115 455
CHANGES IN DIRECT SPENDING\a\
Estimated Budget Authority.............................. -22 -71 0 30 5 -58
Estimated Outlays....................................... -22 -71 0 30 5 -58
----------------------------------------------------------------------------------------------------------------
Note; DHS = Department of Homeland Security; HHS = Department of Health and Human Services.
\a\ Over the 2011-2020 period, CBO estimates that enacting the bill would reduce direct spending by $23 million.
Basis of estimate: CBO estimates that implementing H.R.
5498 would cost $455 million over the 2011-2015 period,
assuming appropriation of the necessary funds. We estimate that
enacting the bill also would reduce direct spending by $58
million over the 2011-2015 period and by $23 million over the
2011-2020 period. In addition, enacting the bill could have an
insignificant effect on revenues.
Spending subject to appropriation
For this estimate, CBO assumes that the necessary amounts
will be appropriated near the start of each fiscal year and
that spending will follow historical patterns for similar
activities.
DSH Programs. CBO estimates that H.R. 5498 would authorize
the appropriation of $279 million over the 2011-2015 period for
several DHS programs and activities.
H.R. 5498 would authorize the appropriation of $50 million
annually over the 2011-2013 period for the Federal Emergency
Management Agency to make grants to state, local, and tribal
governments and nonprofit organizations to improve security at
laboratories that contain toxins that present a threat to
national security. CBO estimates that implementing this grant
program would cost $98 million over the 2011-2015 period, and
an additional $52 million after 2015.
The bill would authorize DHS to reimburse state and local
laboratories for their costs to participate in the BioWatch
program, which includes a system of monitors placed near urban
areas to detect biological attacks. About 30 labs participate
in BioWatch, and each spends, on average, about $400,000
annually on this activity. We estimate that it would cost $57
million over the 2011-2015 period to cover the labs' expenses.
The legislation also would direct DHS to establish a
program to evaluate the effectiveness of tests to detect
certain pathogens. Based on information from DHS about the cost
of similar programs, we estimate that it would cost $47 million
over the five- year period to carry out this activity.
H.R. 5498 would require DHS to establish regulations for
security measures at laboratories that contain certain toxins.
Based on the costs of similar activities, CBO estimates that it
would cost DHS about $9 million to carry out this provision and
to assist the Departments of Agriculture and HHS in enforcing
the new regulations over the next five years.
Finally, H.R. 5498 also would require DHS to develop
strategies, share information, and prepare reports relating to
threats from weapons of mass destruction. CBO estimates that it
would cost $8 million over the 2011-2015 period to carry out
those activities.
HHS Programs. CBO estimates that H.R. 5498 would authorize
the appropriation of $268 million over the 2011-2015 period for
activities to be conducted by HHS.
H.R. 5498 would require HHS to establish and implement a
strategy for dispensing antidotes or other countermeasures to
mitigate the effects of a terrorist attack with chemical,
biological, radiological, or nuclear materials. Those
activities would overlap to a considerable degree with
activities under Executive Order 13527, issued on December 30,
2009; that order requires the Secretaries of Homeland Security
and HHS to establish mechanisms for providing medical
countermeasures following a biological attack. Based on
information from the Centers for Disease Control and Prevention
(CDC) and accounting for activities already required by that
executive order, CBO estimates that implementing the bill's
requirements would cost $185 million over the 2011-2015 period.
A subsequent executive order, issued on July 2, 2010
(Executive Order 13546), requires the Secretaries of HHS and
Agriculture to establish a tiered list of select materials
considered threats to the United States. H.R. 5498 would modify
and expand those requirements, and it would require those
agencies to provide DHS with a list of laboratories and other
locations where the most dangerous materials are stored. It
also would require HHS to conduct a review of its vaccination
and antimicrobial dispensing policy and to issue a report with
recommendations to improve that policy. Based on information
from CDC and accounting for overlapping activities specified
within the executive order, CBO estimates that this provision
would cost $34 million over the 2011-2015 period.
Other Programs. CBO estimates that H.R. 5498 would
authorize the appropriation of $18 million over the 2011-2015
period for other programs and activities.
The bill would require the Department of Agriculture (along
with HHS) to enforce security regulations for laboratories that
contain certain agents. Based on information from the
Department of Agriculture, CBO estimates that it would cost the
department $10 million to carry out this responsibility over
the next five years.
H.R. 5498 would direct the Environmental Protection Agency
(EPA) to assess the capability of federal, state, tribal, and
local governments to recover from attacks involving chemical,
biological, radiological, or nuclear materials. The bill would
require the agency to develop exercises and provide guidance
for state, local, and tribal governments to improve
environmental decontamination and cleanup methods. Based on
information from EPA, CBO estimates it would cost the agency
about $5 million in 2011 to carry out those activities.
Section 403 would require the Secretary of State to
establish an interagency task force to examine the current
state of--and methods for improving--global preparedness for a
major biological attack. The task force would include
representatives from several federal departments, including
DHS, HHS, and the Department of Defense, and would be required
to submit a report detailing its findings to the Congress
within 18 months of the bill's enactment. Based on the cost of
similar efforts, CBO estimates that operating the task force
would cost approximately $1 million in 2011 and less than
$500,000 in 2012, assuming the availability of appropriated
funds.
H.R. 5498 would authorize the appropriation of $1 million
for fiscal year 2011 for the National Academy of Sciences to
prepare a report for the Congress on the use of forensic
science to improve homeland security. We estimate that most of
those funds would be spent in 2011.
Direct spending and revenues
The Project Bioshield Act, enacted in 2004, provides
funding for purchasing vaccines and pharmaceutical products
that could be used in the event of a chemical, biological,
radiological, or nuclear threat. Under that act, HHS, with the
concurrence of HHS and approval of the Office of Management and
Budget, can enter into contractual agreements to purchase those
products up to eight years before they would otherwise be
approved for sale to the public. Provisions in H.R. 5498 would
alter the criteria for procurement of those vaccines and
pharmaceutical products.
CBO anticipates that the new criteria would slow the
procurement process for a subset of vaccines and pharmaceutical
products by about one year. The delay in procurement is not
expected to change total spending under Project Bioshield;
however, it would delay some Bioshield spending until after
2020. CBO estimates that enacting those provisions would.
reduce direct spending by $58 million over the 2011-2015 period
and $23 million over the 2011-2020 period.
H.R. 5498 could increase revenues because the legislation
would establish civil penalties for violations of the security
regulations established by DHS. Civil lines are recorded as
revenues and deposited in the Treasury. CBO estimates that any
additional revenues would not be significant because of the
small number of cases likely to be affected.
Pay-As-You-Go considerations: The Statutory Pay-As-You-Go
Act of 2010 establishes budget-reporting and enforcement
procedures for legislation affecting direct spending or
revenues. The changes in outlays and revenues that are subject
to those pay-as-you-go procedures, are shown in the following
table.
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------------------------------------------------------------
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2011-2015 2011-2020
--------------------------------------------------------------------------------------------------------------------------------------------------------
NET INCREASE OR DECREASE (-) IN THE DEFICIT
Statutory Pay-As-You-Go Impact.................... -22 -71 0 30 5 5 0 9 21 0 -58 -23
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intergovernmental and private-sector impact: Under current
law, laboratories must register with the National Select Agent
Registry if they possess, use, or transfer select materials or
toxins. They must also comply with security standards for
conducting risk assessments. H.R. 5498 would impose additional
duties on laboratories if they possess, use, or transfer select
materials or toxins that are designated as tier I threats.
Those laboratories would be required to comply with new
security standards in addition to new standards for conducting
background checks, training personnel, and performing
vulnerability assessments.
The duty to comply with the new federal regulations would
impose intergovernmental and private-sector mandates as defined
in UMRA. The Secretary of HHS in coordination with the
Secretary of DHS would have broad authority to add to or remove
materials from the list of tier I threats at any time. Because
the number of laboratories that would be affected and the types
of security measures required would depend on those future
regulatory actions and would therefore be difficult to predict,
CBO cannot estimate the cost of the mandates. Consequently, CBO
cannot determine whether resulting costs would exceed the
annual thresholds for intergovernmental or private-sector
mandates ($70 million and $141 million in 2010, respectively,
adjusted annually for inflation).
Grant funds authorized in the bill for enhancing security
at laboratories would benefit certain, state, local, and tribal
governments, including public institutions of higher education.
Estimate prepared by: Federal Costs: DHS--Mark Grabowicz,
HHS--Ellen Werble, Stephanie Cameron, and Jamease Kowalczyk,
Department of Agriculture--Greg Hitz, Department of State and
Intelligence Programs--Jason Wheelock, EPA--Susanne Mehlman;
Impact on State, Local, and Tribal Governments: Lisa Ramirez-
Branum; Impact on the Private Sector: Sarah Axeen.
Estimate approved by: Theresa Gullo, Deputy Assistant
Director for Budget Analysis.
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. 5498 contains the following
general performance goals, and objectives, including outcome
related goals and objectives authorized.
The purpose of H.R. 5498 is to enhance homeland security by
improving efforts to prevent, deter, prepare for, detect,
attribute, respond to, and recover from attacks involving a
weapon of mass destruction (WMD).
The goals of this legislation are to prevent, deter,
prepare for, detect, attribute, respond to, and recover from
attacks with WMD or WMD agents. H.R. 5498 takes a comprehensive
approach to the threat that terrorists will attempt to attack
the United States with chemical, biological, radiological or
nuclear materials and provides a comprehensive response to such
a threat.
The objectives of H.R. 5498 are:
Improving the capabilities of the United States to
collect, analyze, and disseminate WMD-related
intelligence;
Integrating national biosecurity and biodefense
stakeholders into the homeland security intelligence
and information sharing process;
Strengthening of security at laboratories that
possess biological agents that are considered material
threats to the Nation;Preventing terrorists from
accessing sensitive United States technology and
munitions as well as WMD components, precursors, and
delivery systems;
Increasing the awareness of manufacturers and
exporters of strategic technologies or commodities
through industry outreach;
Requiring the coordination of law enforcement
counter-proliferation investigations and intelligence
counter-proliferation activities;
Disseminating appropriate WMD threat information and
alerts to State, local, and tribal authorities, and the
United States public;
Improving WMD-related information dissemination from
the Federal government to State, local, and tribal
authorities;
Developing and disseminating guidance and other
information for individual and community preparedness
for and collective response to a WMD attack;
Establishing a national biosurveillance strategy to
increase awareness of the biological threat and
identify acts of bioterrorism as soon as possible;
Improving the performance of the National
Biosurveillance Integration Center;
Improving the selection, procurement, use, and
maintenance of emergency responder equipment through
the System Assessment and Validation for Emergency
Responders program;
Providing integrated laboratory support to Federal
law enforcement agencies as they investigate incidents
involving WMD and/or their agents;
Establishing a national bioforensics strategy to
increase national bioforensics capabilities;
Improving recognition of and response to situations
involving potential biological threats, including the
performance of coordinated joint criminal and
epidemiological investigations;
Developing voluntary guidance for first responders,
first providers, and others to follow when responding
to a WMD attack or event;
Developing and issuing guidance for clean-up and
restoration of areas that have been affected by a
biological attack or event, with submission of a report
to the appropriate Congressional committees within one
year of enactment and annually thereafter regarding
this guidance;
Improving preparedness for environmental recovery
from WMD attacks or events and requiring the submission
of a progress report on the assessment of preparedness
requirements for environmental recovery to the
appropriate Congressional committees no later than one
year after enactment;
Improving biotechnology research, development, and
procurement by directing that boundaries for the
research activities of the National Institutes of
Health, the Biodefense Advanced Research and
Development Authority, and the Project BioShield
Special Reserve Fund be established;
Evaluating whether agents already identified as
material threats to the Nation still pose threats
sufficient to affect United States homeland security
and national security;
Ensuring that United States vaccination and
antimicrobial distribution policies are adequate to
respond to the risks of terrorist-sponsored biological
attacks or to other events with significant health
consequences to the United States;
Reducing the misuse of life sciences and enhancing
global biosecurity through increased international
collaboration and information sharing;
Increasing international engagement to enhance
biodefense and biosecurity;
Identifying and communicating best practices for
preparedness based on lessons learned from United
States domestic efforts that may be useful or
applicable internationally; and
Promoting the Biological and Toxin Weapons
Convention.
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.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of Rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 1, which grants Congress the power
to provide for the common Defense of the United States.
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
TITLE I--INTELLIGENCE MATTERS
Section 1. Short Title; Table of Contents.
This Act may be cited as the ``WMD Prevention and
Preparedness Act of 2010.''
Section 2. Definitions.
This section defines the following terms: (1) ``appropriate
congressional committees''; (2) ``weapon of mass destruction'';
(3) ``Intelligence Community''; and (4) ``national biosecurity
and biodefense stakeholders.''
The Committee intends for the term ``biosecurity and
biodefense stakeholders'' to be broadly construed and include
officials from the Federal, State, local, and tribal
authorities and individuals from the private sector who are
involved in efforts to prevent, deter, prepare for, detect,
attribute, 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.
Section 101. National Intelligence Strategy for Countering
the Threat from WMD.
This section directs the Director of National Intelligence,
in consultation with the Secretary of Homeland Security and the
heads of other appropriate Federal departments and agencies, to
develop the National Intelligence Strategy for Countering the
Threat from WMD and an associated implementation plan. The
purpose of the strategy is to improve the capabilities of the
United States to collect, analyze, and disseminate intelligence
related to WMD. The strategy shall address workforce issues,
collaboration, domestic analysis and collection, and each type
of WMD. The Director of National Intelligence shall, as the
Director considers appropriate, coordinate with nongovernmental
organizations and members of the public and private sectors to
develop the strategy.
The implementation plan shall include actions to better
share intelligence on WMD throughout the Intelligence
Community, disseminate WMD intelligence to stakeholders in
unclassified formats, and provide open-source WMD intelligence
to others in the public and private sectors. The implementation
plan shall also include objectives to be accomplished over a
five-year period, assignment of roles and responsibilities to
elements of the Intelligence Community, and a schedule for
assessment of the effectiveness and efficiency of the strategy.
The Director of National Intelligence shall, as the
Director considers appropriate, coordinate with nongovernmental
organizations and members of the public and private sectors to
develop the strategy.
Not later than one year after enactment of this
legislation, the Director of National Intelligence, in
consultation with the Secretary of Homeland Security, shall
submit the strategy and implementation plan to the appropriate
congressional committees. The report shall be in unclassified
form, but may include a classified annex as appropriate.
The Committee recognizes that the Intelligence Community
addresses the WMD threat in various parts of the National
Intelligence Strategy; however, the Committee 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.
Section 102. National Intelligence Strategy for Countering
Biological Threats.
This section directs the Director of National Intelligence,
in consultation with the Secretary of Homeland Security and the
heads of other appropriate Federal departments and agencies, to
develop and implement the ``National Intelligence Strategy for
Countering Biological Threats'' and an implementation plan for
the strategy. This strategy should be integrated into the
National Intelligence Strategy for Countering the Threat from
Weapons of Mass Destruction.
The strategy shall include a plan for increasing the number
of individuals in the Intelligence Community and collaboration
with those in the private sector that have the experience,
education, and expertise to better collect information and/or
analyze that information to produce intelligence that addresses
the biological threat.
The strategy shall also address domestic and international
intelligence needs regarding the biological threat, seek
improvement of tactical and strategic intelligence regarding
the threat, ensure that the commitment of human and other
resources to address the biological threat is sustained, and
make the biological threat an intelligence priority.
The implementation plan shall include actions to share
intelligence throughout the Intelligence Community on
biological weapons and organisms that could be used for
biological terrorism, and shall address the strategic and
tactical intelligence activities (i.e., human intelligence,
measurement and signature intelligence, technical intelligence,
medical intelligence, and open source intelligence) necessary
to implement the strategy.
The implementation plan shall also include objectives to be
accomplished over a five-year period, assignment of roles and
responsibilities to elements of the Intelligence Community, a
schedule for assessment of the effectiveness and efficiency of
the strategy, and a schedule for regularly evaluating effort
and progress in understanding and countering the biological
threat.
Not later than one year after enactment, the Director of
National Intelligence, in consultation with the Secretary of
Homeland Security, shall submit the strategy and implementation
plan to the appropriate congressional committees. The report
shall be in unclassified form but with a classified annex, as
appropriate.
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.
The Committee believes that the Intelligence Community's
capability to address the unique aspects of biological WMD
threats would be enhanced by the recruitment of more personnel
who can understand, analyze, and collect information on the
biological threat. To better hire, attract, recruit, and retain
these experts, the Committee believes that the Director of
National Intelligence should first define the functions,
capabilities, and gaps that exist in the current intelligence
workforce.
TITLE II--HOMELAND SECURITY MATTERS
Section 201. Weapons of Mass Destruction Prevention and
Preparedness.
This section amends the Homeland Security Act of 2002 by
adding a new ``Title XXI--Weapons of Mass Destruction
Prevention and Preparedness.'' This new title is comprised of
six subtitles, which address all aspects of counter-WMD
activities: (A) prevention and deterrence; (B) preparedness;
(C) detection; (D) attribution; (E) response; (F) recovery.
Subtitle A--Prevention and Deterrence
Section 2101. Weapons of Mass Destruction Intelligence and
Information Sharing Unit.
This section establishes a unit for WMD intelligence and
information sharing in the Department of Homeland Security
Office of Intelligence and Analysis. This office shall conduct
intelligence-sharing activities in accordance with the National
Intelligence Strategy for Countering the Threat from WMD
(section 101 of this Act) and the National Intelligence
Strategy for Countering Biological Threats (section 102 of this
Act). The unit will analyze information regarding: (1)
terrorist actors, claims, and plans for chemical, biological,
radiological, and nuclear attacks; and (2) global infectious
disease, public health, food, agricultural, and veterinary
issues that could impact homeland security. Also, the unit will
provide State, local, and tribal authorities, as well as
members of the public health, scientific, and response
communities with analytical support on the WMD threat and
perform other responsibilities, as assigned by the Secretary.
Where appropriate, the unit shall coordinate with others in the
Intelligence Community.
Not later than one year after the date of enactment and
annually thereafter, the Secretary shall report to the
appropriate congressional committees on the intelligence and
information sharing activities to counter the threat from WMD
conducted by this unit and all relevant entities within the
Department. The Secretary will also report on how the
Department acted in accordance with relevant intelligence
strategies.
The Committee intends to authorize a pre-existing unit (or
any successor) within the Office of Intelligence and Analysis
of the Department of Homeland Security that is engaged in WMD
intelligence and information sharing activities. 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, and
State, local, and tribal authorities in order to advance the
Department's counter-WMD activities. State, local, and tribal
participation, in particular, should include officials from
high threat areas. The Committee does not intend for this unit
to conduct the same activities 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 will ensure clarity of
mission.
Section 2102. Information Sharing and Collaboration for
Biosecurity and Biodefense.
This section increases situational awareness for homeland
security purposes with respect to biological threats. The
section directs the Secretary, acting through the Under
Secretary for Intelligence and Analysis, to: (1) integrate
national biosecurity and biodefense stakeholders into the
homeland security, intelligence, and information sharing
process; (2) develop a framework for homeland security
intelligence and information sharing with national biosecurity
and biodefense stakeholders; (3) enable these stakeholders to
provide recommendations on how to integrate information they
possess into the homeland security, intelligence, and
information sharing process; (4) leverage fusion centers (and
other homeland security capabilities and structures) to counter
biological attacks or other phenomena that may have serious
health consequences for the United States, such as wide-scale
fatalities or infectious disease outbreaks; and (5) partner
with other Federal departments and agencies to perform
biological threat and risk assessments. The Secretary shall
coordinate with the Secretary of State, the Secretary of
Agriculture, the Secretary of Health and Human Services, and
the heads of other appropriate Federal agencies in carrying out
these activities.
The Committee intends for intelligence and information
sharing activities to: (1) build upon the existing
intelligence-sharing programs established by public health and
health care deliverers; (2) expand to incorporate the larger
group of national biosecurity and biodefense stakeholders,
including local officials from high threat areas; and (3)
obtain input from national biosecurity and biodefense
stakeholders on how to integrate information gathered from
these stakeholders to increase situational awareness. The
Committee also intends for the Office of Intelligence and
Analysis to continue to manage and facilitate this activity.
Section 2103. Bioterrorism Risk Assessments.
This section directs the Secretary, in coordination with
the heads of other appropriate Federal departments and
agencies, to produce biennial integrated Bioterrorism Risk
Assessments to identify and assess the evolving terrorist risk
of a biological attack or other phenomena that may have serious
health consequences for the United States, such as wide-scale
fatalities or infectious disease outbreaks. These assessments
shall: (1) identify the threat, vulnerability, and consequences
of a biological terrorist attack against the United States; (2)
take into account intelligence and information regarding
terrorist intentions, capabilities, plans, and actions; (3)
inform and guide other homeland security biological threat
assessments and determinations, and help determine the
prioritization of other homeland security activities, as
appropriate; (4) inform investments in national strategic
biodefense research, development, planning, preparedness, and
collective response to biological attacks; (5) identify key
gaps in knowledge and data regarding the biological threat; (6)
define critical biodefense vulnerabilities; (7) prioritize
agents that could be used for bioterrorism, based on risk; and
(8) evaluate progress in implementing national biopreparedness
policy.
To execute these activities, the Secretary shall: (1)
convene an interagency task force of subject matter experts to
advise the Department of Homeland Security Under Secretary for
Science and Technology on whether the methodology used in the
Assessments is adequate and to establish requirements and
standards for these Assessments; (2) solicit input from
national biosecurity and biodefense stakeholders about the
Assessments, as appropriate; and (3) ensure that the
Assessments inform the risk management decisions of the
Department and can be made available to national biosecurity
and biodefense stakeholders, as appropriate.
The Committee acknowledges that the Science and Technology
Directorate of the Department of Homeland Security presently
undertakes outreach to experts to help assess the risk of
bioterrorism. The Committee urges the Science and Technology
Directorate to continue to seek the opinion of experts in risk
assessment, the threat of bioterrorism, and other relevant
disciplines (e.g., threat assessment, consequence
determination, and vulnerability assessment) in order to help
ensure that the Bioterrorism Risk Assessments remain relevant.
The Committee urges the Science and Technology Directorate to
address the criticisms that have been levied at the
Bioterrorism Risk Assessments; it believes that engaging these
criticisms will enhance the assessments' credibility and
utility. The Committee urges the Science and Technology
Directorate to continue to improve the methodology used to
develop the Bioterrorism Risk Assessments and seek assistance
from the Office of Risk Management and Analysis (within the
National Protection and Programs Directorate) and the Office of
Intelligence and Analysis. The Committee also urges the Science
and Technology Directorate to make maximum use of persons
within the Department of Homeland Security who could advise on
information sharing, intelligence, and methodology, and provide
other relevant insights.
The Committee recognizes the need for the sharing of the
bioterrorism risk assessment with Federal, State, local, and
tribal agencies and be made available to the State, local and
tribal first responder community so as to inform their
bioterrorism preparedness activities. Further, the Committee
recommends that the representatives from the first responder
community at the State, local, and tribal levels be provided
the opportunity to participate, as appropriate, in the
bioterrorism risk assessment task force.
Section 2104. Radiological Materials Security.
This section directs the Secretary to conduct annual risk
assessments regarding the threat, vulnerability, and
consequences of theft or other procurement of radiological
materials that could be used by a terrorist in a radiological
dispersion device. These radiological risk assessments shall
include any specific threat information regarding possible
terrorist attacks using a radiological dispersion device.
In conducting these radiological terrorism risk
assessments, the Secretary shall: (1) consult with the
Secretary of Energy, the Secretary of Heath and Human Services,
and the Nuclear Regulatory Commission; (2) consider relevant
studies conducted by other Federal agencies, or other reputable
organizations; (3) designate certain materials as high-risk
radiological materials; (4) consider the availability, ability
to disperse, and ease of handling various radiological
materials; (5) assess the vulnerability of different facilities
for theft or other procurement of radiological materials; (6)
consider the consequences of a successful radiological
dispersion device attack as these consequences may include
death, injury, and economic loss; and (7) consult with the
Intelligence Community, the Secretary of Energy and the Field
Intelligence Elements of the National Laboratories, and the
Nuclear Regulatory Commission, the Secretary of Health and
Human Services, and other appropriate experts.
The Secretary shall disseminate the findings of the
radiological terrorism risk assessments and any associated
specific risk information to all participating agencies as well
as to State and local agencies and to those facilities that
both house radiological source material and are regulated by
the Nuclear Regulatory Commission. The Secretary shall, as
appropriate, share these radiological terrorism risk
assessments with law enforcement and critical infrastructure
operators with appropriate security clearances. The Secretary
shall also make available an unclassified version to each
agency with which the Secretary is required to consult, State
and local law enforcement and public health authorities, and
facilities that the Department of Energy has authorized to
possess radiological materials.
The Committee believes that radiological materials used in
medical, industrial, academic, and other facilities must be
secured to prevent theft and use in a radiological dispersion
device by terrorists. The Committee intends for the Secretary
of Homeland Security to take additional and measured steps to
secure these materials by conducting a radiological terrorism
risk assessment that will serve both as the basis for future
action and to inform Federal and non-Federal agencies and
organizations that possess or otherwise deal with radiological
materials. In accordance with the definition of unclassified
information, the Committee does not intend for the unclassified
version of the risk assessment to contain information that
would increase the vulnerability to a radiological terrorist
attack or the number of crimes involving the theft of these
radiological materials.
Section 2105. Enhanced Biosecurity Measures.
This section directs the Secretary, in consultation with
the Secretary of Agriculture, the Secretary of Health and Human
Services, and the heads of other appropriate Federal agencies,
to establish enhanced biosecurity measures for persons or
laboratories that possess, use, or transfer Tier I Material
Threat Agents, using a negotiated rulemaking committee. The
biosecurity measures to be established shall include: (1)
standards for personnel surety programs; (2) standards for
biosecurity practices and training of responsible officials,
laboratory personnel, and support personnel; (3) standards for
performing laboratory vulnerability assessments; (4) risk-based
laboratory security performance standards; (5) penalties
(including civil money penalties and intermediate sanctions) in
addition to any other penalties that may apply; and (6) any
other security standards determined necessary by the Secretary,
the Secretary of Agriculture, the Secretary of Health and Human
Services, and other agencies as appropriate. Any
recommendations with respect to proposed regulations shall be
provided to the Secretary and the heads of the other
appropriate Federal agencies not later than one year after the
date of enactment of this section. A final rule shall be
promulgated no later than two years after enactment of this
Act.
The negotiated rulemaking committee shall include a
representative from: (1) the Department of Homeland Security;
(2) the Department of Health and Human Services; (3) the
Department of Agriculture; (4) the Department of Defense; (5)
the Department of Energy; (6) the Department of Justice; (7)
for-profit research institutions; (8) academic research
institutions; (9) non-profit research institutions; and (10)
other stakeholders, as the Secretary determines appropriate.
The negotiated rulemaking committee should consider the
following factors: (1) the recommendations of the Commission on
the Prevention of Weapons of Mass Destruction Proliferation and
Terrorism; (2) the National Science Advisory Board for
Biosecurity; (3) any working group established under Executive
Order 13486 relating to strengthening laboratory biosecurity;
(4) the Chemical Facility Anti-Terrorism Act of 2009; and (5)
methods to minimize any disincentives to biological research
arising from enhanced biosecurity measures.
The Secretary of Agriculture and the Secretary of Health
and Human Services shall: (1) enforce the measures established
and any standards promulgated, in consultation with the
Secretary, as appropriate; (2) develop training programs that
comply with such measures and standards, in coordination with
the Secretary and the heads of other Federal agencies, as
appropriate; and (3) develop and implement procedures that
determine when and how penalties and intermediate sanctions may
be imposed, in consultation with the Secretary and the heads of
other Federal agencies, as appropriate.
With respect to inspections, the Secretary of Agriculture
and the Secretary of Health and Human Services shall
periodically provide the Secretary with all data concerning
inspections of laboratories that handle Tier 1 Material Threat
Agents. This data will help to ensure that the regulations are
uniformly enforced and to identify areas where the Secretary
can advise the Secretary of Agriculture or the Secretary of
Health and Human Services on approaches to enhancing security
at specific laboratories. Inspections of the same laboratories
by different Federal agencies shall be conducted simultaneously
to the greatest extent practicable and shall use common
inspection procedures in order to minimize the administrative
burden on these laboratories. Each inspection report shall be
made available to each laboratory that is the subject of the
inspection as well as each Federal agency that supports
laboratory activities at that laboratory.
The Committee intends for a top tier of Select Agents that
pose material threats to the Nation be developed. The Committee
intends for laboratories that contain these Tier 1 Material
Threat Agents to be better secured. The Committee believes that
the Department of Homeland Security will be responsible for
addressing cases in which these agents are obtained illicitly,
used for terrorist purposes, or accidentally released. The
Committee further observes that the two Departments in charge
of the Select Agent Program-the Department of Agriculture and
the Department of Health and Human Services-are not national
security organizations. Therefore, the Committee believes that
the Department of Homeland Security should have a substantial
role in developing security protocols to enhance security at
laboratories containing Tier 1 Material Threat Agents.
The Committee intends for the Department of Homeland
Security to be responsible for convening a negotiated
rulemaking committee, composed of representatives from every
Federal Department and agency, as well as private sector
agencies, that work with, transfer, obtain, or otherwise
process Tier 1 Material Threat Agents. The Committee encourages
the Secretary to include local officials, including first
responders, from high threat areas as participants. The
Committee intends for this negotiated rulemaking committee to
consider the threat posed by Tier 1 Material Threat Agents, the
threat to facilities that contain these agents, and the ability
of our nation's enemies to obtain and use these agents. The
Committee also intends for the negotiated rulemaking committee
to issue any necessary new standards, rules, and requirements
for securing Tier 1 Material Threat Agents. In addition, the
Committee intends for the Department of Agriculture and the
Department of Health and Human Services to enforce any new
regulations. However, due to the potential impact on the Nation
and implications for action by the Department of Homeland
Security, the Committee intends for the Department of
Agriculture and the Department of Health and Human Services to
report inspection and other regulatory data to the Department
of Homeland Security. This reporting of data will allow the
Department of Homeland Security to better advise and make
recommendations regarding security at laboratories that possess
Tier 1 Material Threat Agents and to provide these laboratories
with additional grants so that they may increase their
security.
The Committee does not intend for the Department of
Homeland Security to supplant efforts by other Federal agencies
(including those of the Department of Agriculture and the
Department of Health and Human Services) to enforce Select
Agent regulations. However, the Committee does not believe that
laboratories containing Select Agents are as secure as they
could be; this fact is evidenced by incidents and inspections
(such as those conducted by the Inspector General) that reveal
insufficient security. The Committee also agrees with the
assessment of the Commission that laboratory security must be
increased. Therefore, the Committee intends for the Department
of Homeland Security to partner with the Department of
Agriculture and the Department of Health and Human Services in
order to improve laboratory security for those laboratories in
possession of Tier 1 Material Threat Agents.
The Committee urges all Federal departments and agencies
that conduct inspections of laboratories possessing Tier 1
Material Threat Agents (as part of regulating Select Agent
laboratories, ensuring contractors are performing in accordance
with contractual obligations to the government, and so forth)
to conduct these inspections in a manner that seeks to minimize
disruption to affected laboratories. The Committee urges
inspections be coordinated among Federal departments and
agencies so as to avoid unnecessary duplicative inspections.
The Committee also intends for Federal Departments and agencies
to share inspection information in order to identify any
ongoing security problems at particular laboratories.
The Committee intends for a representative from the Office
of the Director of National Intelligence to participate in the
activities addressed in this section. The Committee anticipates
that the representative can articulate how agency decisions
(particularly decisions made by the negotiated rulemaking
committee) will impact research and development efforts by the
Intelligence Community as well as other activities within the
Community. The Committee also intends for these measures to
enhance laboratory security for Tier 1 Material Threat Agents,
while simultaneously allowing for legitimate research
activities to continue. Additionally, the Committee intends for
this section to support and reinforce Presidentially-driven
reforms of laboratory security activities to avoid
unnecessarily redundant burdens on research and allow for input
from all relevant Federal departments and agencies regarding
laboratory security requirements.
Section 2106. Tier 1 Material Threat Agent Locations.
This section directs the Secretary of Agriculture and the
Secretary of Health and Human Services to provide to the
Secretary of Homeland Security (at the request of the
Secretary) with lists of laboratories and other locations where
Tier 1 Material Threat Agents are present in the United States
and its territories.
The Committee intends for the Department of Homeland
Security to know where all laboratories possessing Tier 1
Material Threat Agents are located in the United States and its
territories. However, the Committee does not intend for the
Department of Homeland Security to replicate work that is
already being done by the Department of Agriculture and the
Department of Health and Human Services regarding Select Agent
laboratories (of which Tier 1 Material Threat Agent
laboratories are only a portion). The Committee intends for the
Department of Agriculture and the Department of Health and
Human Services to provide lists of Tier 1 Material Threat Agent
laboratories and their locations to the Department of Homeland
Security at the request of the Secretary of Homeland Security
and as often as the Department of Agriculture and the
Department of Health and Human Services feel is necessary to
help ensure homeland security. The Committee intends for
classified information (such as classified locations) to be
communicated to the Department of Homeland Security, and for
the Department to handle this information in accordance with
the rules and procedures that protect classified information.
Section 2107. High Containment Biological Laboratory Security
Grants.
This section permits the Secretary of Homeland Security to
provide grants to academic and non-profit organizations and to
State, local, and tribal authorities to enhance the security of
those laboratories that handle Tier 1 Material Threat Agents
and other agents requiring high containment. This section
authorizes the Secretary, acting through the Administrator of
the Federal Emergency Management Agency, to award grants based
on risk to academic and non-profit organizations and to State,
local, and tribal authorities that possess, use, or transfer
Tier I Material Threat Agents. The grants are designed to
enhance security at laboratories handling Tier 1 Material
Threat Agents. This section authorizes $50,000,000 per year to
be appropriated for fiscal years 2011 through 2013 to the
Department of Homeland Security.
The Committee intends to raise the security standards at
laboratories that possess Tier 1 Material Threat Agents. The
Committee believes that it would not be fair to ask high
containment laboratories to take make new investments to
increase laboratory security to address the WMD threat without
providing funding to help the laboratories meet the higher
security standards. The Committee intends for funding provided
under this section to augment (not replace) funding provided by
other Federal departments and agencies. The Committee intends
for these grants to be awarded to State, local and tribal
public health laboratories as well as to academic and non-
profit laboratories that find their activities would be limited
without the additional funding necessary to achieve the higher
laboratory security standards for Tier 1 Material Threat
Agents. Such laboratories include, but are not limited to the
regional biocontainment laboratories, including Biosafety Level
4 laboratories, that received awards from National Institutes
of Health.
Section 2108. Laboratory Biosecurity Information Sharing.
This section directs the Secretary of Homeland Security to
establish procedures (with appropriate access controls) for the
sharing of homeland security information (vulnerability
assessments, security plans, best practices, and other
laboratory biosecurity-related information) with, as the
Secretary determines appropriate, State, local, and tribal
government authorities, including law enforcement authorities
and emergency response providers. In carrying out this
responsibility, the Secretary shall have access to and may use
information from the national databases established under
section 212(d)(2) of the Agricultural Bioterrorism Protection
Act of 2002 (7 U.S.C. 8401(d)(2)) and subsections (d)(2) and
(f)(3) of section 351A of the Public Health Service Act (42
U.S.C. 262a). The Committee intends for any information
disseminated under this section to be handled in accordance
with rules and procedures for protecting classified information
and sensitive law enforcement information, intelligence
sources, and intelligence methods.
The Committee intends for the Department of Homeland
Security to share information necessary to improve and ensure
high containment laboratory security-particularly regarding
those laboratories that possess Tier 1 Material Threat Agents.
The Committee believes that it is important for State, local,
and tribal authorities to participate fully in the homeland
security mission, and that in order to do so, these authorities
must be empowered with knowledge. The Committee urges the
Department of Homeland Security to share as much information as
possible with State, local, and tribal authorities in order to
help these authorities take the necessary actions and maintain
the necessary awareness to secure laboratories, transport
Select Agents (including Tier 1 Material Threat Agents), and so
forth. Although the Committee believes that the Department of
Homeland Security has taken some actions to date in this
regard, the Committee believes that the entire community would
benefit from the Department of Homeland Security establishing
clear procedures, with appropriate controls for access to, and
for the sharing of, this homeland security information.
Section 2109. Periodic Homeland Security Review of Criminal
Statutes.
This section directs the Secretary, in coordination with
the Attorney General and the heads of other Federal departments
and agencies, as appropriate, to address the risk of misuse of
life sciences by terrorists and others. The bill requires the
Secretary to: (1) periodically review and recommend updates to
relevant criminal laws; and (2) ensure that relevant guidance
is available to national biosecurity and biodefense
stakeholders. Not later than one year after enactment and
biannually thereafter, the Secretary, in coordination with the
Attorney General, shall submit to the appropriate congressional
committees recommended updates to relevant criminal laws.
The Committee is concerned that, in some instances, the law
enforcement community may have been hindered by criminal laws
that do not adequately address the threat or are not well
suited to the evolving risks of the misuse of life sciences.
The Committee believes that criminal law may need to evolve as
the threat evolves.
Section 2110. Export Enforcement for Counter-Proliferation.
This section authorizes the Secretary of Homeland Security,
in coordination with the Secretary of Commerce, the Secretary
of Defense, the Attorney General, the Secretary of State, the
Secretary of the Treasury, the Director of National
Intelligence, and the heads of other appropriate Federal
Departments and agencies, to conduct homeland security
investigations and enforce criminal violations of United States
customs and export laws to prevent individuals and terrorist
groups from obtaining sensitive United States technology and
munitions, and WMD components, precursors, and delivery
systems. This section also directs the Secretary of Homeland
Security to conduct outreach to United States manufacturers and
businesses that export technologies or commodities that both
terrorist organizations (and the countries that support them)
and countries that proliferate weapons may try to procure. The
outreach should be conducted in a manner that acknowledges
commerce and trade. Additionally, this section directs the
Secretary to manage national export enforcement coordination at
the Department of Homeland Security, with participants from the
Department, the Department of Commerce, the Department of
Defense, the Department of Energy, the Department of Justice,
the Department of State, the Intelligence Community, and other
Federal agencies as appropriate. Law enforcement counter-
proliferation investigations, intelligence counter-
proliferation activities, licensing, and outreach to and
training for the export trade community will be coordinated.
The Committee supports the Obama 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, most notably U.S. Immigration
and Customs Enforcement's counter-proliferation efforts. The
Committee recognizes the investigations that Immigration and
Customs Enforcement and other Federal law enforcement agencies
conduct in this regard, and intends to better support these
efforts. The Committee also believes that outreach to the
private sector is critical, and intends to authorize industry
outreach activities like those conducted by U.S. Immigration
and Customs Enforcement.
The Committee intends to authorize export enforcement
coordination activities already occurring under the auspices of
Immigration and Customs and Enforcement in the Department of
Homeland Security; it 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.
Subtitle B--Preparedness
Section 2121. Communication of Threat Information and Alerts.
This section directs the Secretary of Homeland Security, in
coordination with appropriate Federal agencies, to ensure that
homeland security information concerning terrorist threats is
provided to State, local, and tribal authorities and to the
public within the United States, as appropriate, so that they
can better prepare for and collectively respond to terrorism.
This coordination shall occur through the use of: (1) threat
bulletins; (2) threat and risk assessments; (3) guidance to
State, local, and tribal authorities; and (4) the use of
existing resources (such as websites, communications systems,
and information networks). This section also directs the
Secretary to provide guidance to State, local, tribal and
private sector entities about partnering with and leveraging
public television stations to help disseminate information from
the Department of Homeland Security.
The Committee believes that State, local, and tribal
authorities, as well as the public, are critical partners in
ensuring homeland security. However, in order to be effective
partners, these authorities and the public must be empowered
with knowledge and information. The Committee urges the
Department of Homeland Security to be expansive in its
determination of how much information to share with these
authorities and the public, while also using its best judgment
to determine what and how much information must be secured. The
Department is encouraged to develop a formal mechanism for
early warning to appropriate State, local, and tribal officials
of imminent or highly probable events. Additionally, the
Committee intends for the Department of Homeland Security to
partner with public television stations and use this valuable
resource to better disseminate homeland security information.
Further, the Committee intends for the Department to identify
and provide best practices on leveraging public television to
accomplish these purposes.
Section 2122. Individual and Community Preparedness for
Weapons of Mass Destruction.
This section directs the Secretary of Homeland Security,
acting through the Administrator of the Federal Emergency
Management Agency, to help State, local, and tribal authorities
improve and promote individual and community preparedness for
and collective response to WMD and terrorist attacks. The
Administrator of the Federal Emergency Management Agency shall:
(1) develop and disseminate prevention and preparedness
guidance and checklists; (2) disseminate first responder
guidance regarding WMD attacks; (3) provide preparedness
information and training materials; and (4) conduct outreach.
Where appropriate, the Secretary shall coordinate with private
sector and nongovernmental organizations to carry out these
activities. When compiling this guidance, the Administrator
shall take into account best practices based on the experience
of other countries and agencies, and the expertise of academic
institutions and non-governmental organizations. The Committee
believes that State, local, and tribal authorities, as well as
the public, are critical partners in preparing for and
responding to WMD and terrorist attacks against the United
States. The Committee recognizes that although the Department
of Homeland Security has carried out many activities in this
regard (particularly by the Federal Emergency Management
Agency) the Committee agrees with the Commission that more can
and must be done. The Committee intends for the Federal
Emergency Management Agency to provide State, local, and tribal
authorities, as well as individuals, with the tools, training,
and information they need to prepare for and respond to WMD and
terrorist attacks individually and collectively. To ensure that
the guidance remains relevant, the Federal Emergency Management
Agency Administrator is encouraged to periodically review new
and existing guidance and update such guidance, as appropriate.
The Committee also intends for the Federal Emergency Management
Agency to apply and communicate best practices that other
countries and institutions identify. The Committee urges the
Federal Emergency Management Agency to seek out the expertise
and knowledge available at academic institutions and within
programs like the National Preparedness Leadership Initiative.
Subtitle C--Detection
Section 2131. National Biosurveillance Strategy.
This section directs the Secretary of Homeland Security to
examine the state of national and global biosurveillance and to
develop and maintain a national strategy for biosurveillance.
This strategy shall take into consideration the following: (1)
current biosurveillance activities; (2) homeland security
material threat assessments and determinations; (3) global
trends identified by the Intelligence Community regarding the
biological threat; (4) types of information available in
biosurveillance systems and information technology changes to
better incorporate and integrate this information; (5)
Intelligence Community requirements; and (6) costs associated
with integrating biosurveillance systems. This strategy shall
address: (1) situational awareness; (2) key elements of
biosurveillance information; (3) fostering information sharing
between the public health, law enforcement, security,
intelligence, and life science communities to identify
potential threats, reduce vulnerabilities, and improve
collective response to and investigations of suspected
biological attacks; and (4) the National Biosurveillance
Integration Center resident at the Department of Homeland
Security (including strategic and implementation plans for this
Center).
The Committee believes that there are many challenges
associated with analyzing biosurveillance data sets, collected
nationally and internationally, sharing the data between and
among different professions, and dealing with relevant
classified information. Similarly, developing a national
biosurveillance strategy that addresses these elements is also
challenging. The Committee recognizes that the Department of
Health and Human Services has been trying to meet this
challenge and develop a national biosurveillance strategy
targeted at human disease outbreaks. However, given that
comprehensive biosurveillance draws upon more data sources than
those under the control of the Department of Health and Human
Services, it is important that the Department of Homeland
Security play a central role in developing a national
biosurveillance strategy. At the same time, the Committee
strongly believes in the mission of the National
Biosurveillance Integration Center, as managed by the
Department of Homeland Security but is frustrated with the lack
of participation by other appropriate Federal agencies. The
Committee expects the national strategy to include strategic
and implementation plans for the National Biosurveillance
Integration Center to realize its mission.
Section 2132. Detection of Biological Attacks.
This section establishes the national BioWatch biological
detectors program within the Department of Homeland Security,
and directs the Secretary of Homeland Security to: (1) deploy
these detectors throughout the Nation; (2) provide data
generated by these detectors to participating host laboratories
for their use in monitoring public health; (3) provide data
generated by these detectors to public health and law
enforcement personnel throughout government; and (4) provide
advanced planning tools, concepts of operations (including
alarm resolution protocols) and training for collective
response to and recovery from biological attacks.
This section also directs the Secretary of Homeland
Security to enter into agreements with the Director of the
Centers for Disease Control and Prevention, the Administrator
of the Environmental Protection Agency, and the heads of other
Federal departments and agencies, to set roles and
responsibilities regarding filter testing by and coordination
with State, local, and tribal agencies. The Secretary shall
also determine annually whether the distribution of these
detectors throughout the Nation, as well as their capabilities,
sufficiently protects the United States. Additionally, acting
through the Under Secretary for Science and Technology and in
consultation with the Director of the Centers for Disease
Control and Prevention, the Secretary shall implement an assay
equivalency program for biological threat assays. Additionally,
the Secretary is authorized to contract directly with
participating laboratories for: (1) testing detector filters on
a fee-for-service, prepayment, or other similar basis; and (2)
administrative and other costs regarding hosting BioWatch
personnel and equipment.
The Committee intends to authorize the already existing
BioWatch activity within the Department of Homeland Security.
The Committee recognizes that the success of the BioWatch
program depends on effective interaction with, provision of
information and guidance to, and receipt of support from host
State and local public health laboratories that are also
members of the Laboratory Response Network for Bioterrorism.
The Committee intends for the Department of Homeland Security
to have resources to reimburse the State and local public
health laboratories that host BioWatch activities for
laboratory services and administrative costs.
Section 2133. Rapid Biological Threat Detection and
Identification.
This section directs the Department of Homeland Security
Under Secretary for Science and Technology, in consultation
with the heads of other relevant operational components of the
Department, to assess whether the Department of Homeland
Security Science and Technology Directorate should develop
screening capabilities for biological WMD agents, pandemic
influenza, and other infectious diseases to screen people
entering and exiting the United States at our ports of entry.
If the Under Secretary determines that such screening
capabilities should be developed, the Secretary of Homeland
Security shall, to the extent possible, initiate the
development of such methods that are safe and effective to
rapidly screen incoming travelers at ports of entry for
exposure to biological WMD agents, pandemic influenza, and
other infectious diseases, collaborating with the heads of
other Federal agencies, as needed.
Currently, international borders offer very little
protection from the spread of infectious disease due to the
inability to quickly and effectively screen travelers. The
Committee believes that the Department must assess whether the
use of screening technologies could be effective 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 of the Department to develop these screening
capabilities.
Section 2134. Establishment of the System Assessment and
Validation for Emergency Responders (SAVER) Program.
This section directs the Secretary of Homeland Security,
acting through the Department of Homeland Security Under
Secretary for Science and Technology, to: (1) assess and
validate commercially-produced emergency response equipment and
systems (including hand-held detectors for WMD agents); (2)
ensure that a network of scientists assess and validate the
equipment and systems; (3) provide results and other
information to the emergency response provider community in a
form they find useful in the operational setting; (4) provide
information on the equipment on the Department of Homeland
Security authorized equipment list; (5) provide information to
enable decision-makers and responders to better select,
procure, use, and maintain emergency responder equipment; and
(6) share this information with the emergency response provider
community.
The Committee intends to authorize this already existing
activity within the Science and Technology Directorate of the
Department of Homeland Security. The Committee believes that
many systems and equipment for first responders and others do
not produce sufficiently valid and/or reliable results. The
Committee urges greater support for this program because the
program works to determine the validity and reliability of
these systems and equipment, and to provide that information to
first responders so that they may make better purchasing
decisions. The Committee also urges SAVER program personnel to
reach out to the Federal Bureau of Investigation and other
Federal agencies who have conducted evaluations of such
equipment and systems for other purposes, to get their views
and other relevant input into the program.
Section 2135. Payment for Bioterrorism Laboratory Services.
This section authorizes the Secretary of Homeland Security,
the Attorney General, and the heads of other participating
Federal agencies to contract with State and local laboratories
that compose the Laboratory Response Network (LRN)_and any
other qualified
laboratories_for testing services on a fee-for-service,
prepayment, or similar basis.
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.
Section 2136. Establishment of the Integrated Consortium of
Laboratory Networks (ICLN).
This section establishes the Integrated Consortium of
Laboratory Networks (ICLN) as an activity that is facilitated
by the Secretary of Homeland Security. This section directs
that the ICLN shall: (1) be composed of networks of
laboratories (such as the LRN) capable of and equipped for
conducting the testing necessary for detection, response to,
and recovery from WMD attacks, acts of terrorism, and other
incidents requiring laboratory response capabilities; (2)
ensure that the activities of member laboratory networks are
coordinated and integrated; (3) provide limited containment and
analysis of biological samples in support of the Federal Bureau
of Investigation and other law enforcement agencies as they
investigate incidents involving WMD or WMD agents; and (4)
support studies to characterize threat agents, assay
evaluation, research, and development.
The Committee intends to authorize this already existing
activity within the Department of Homeland Security. The
Committee recognizes that the various laboratory response
networks that are, or could be, members of the ICLN are at
various stages of development. The Committee urges the
Department of Homeland Security to seek consensus in pursuing
ICLN activities (e.g. establishing standards for testing and
reporting). Additionally, the Committee believes that the
Secretary of Homeland Security should consider whether the ICLN
should be moved out of the Science and Technology Directorate
of the Department of Homeland Security and to another
organizational entity within the Department.
The Committee intends for the Department of Homeland
Security to facilitate coordination of the ICLN through its
position as chair and role as executive secretariat of the
ICLN. The Committee believes that the ICLN should be managed by
consensus among the various participating Federal agencies that
participate in the coordination and leadership oversight
activities of the ICLN. The Committee does not intend for ICLN
member laboratories to carry out threat agent characterization
studies and assay evaluation, research, and development
themselves, but instead, the Committee intends for these
laboratories to support those activities carried out by various
Federal Departments and agencies in this regard.
Subtitle D--Attribution
Section 2141. Bioforensics Capabilities and Strategy.
This section establishes the National Bioforensic Analysis
Center (NBFAC) within the Department of Homeland Security and
designates the NBFAC as the lead Federal facility to: (1)
forensically examine biological agents and related evidence;
(2) provide the necessary containment to conduct forensic
examinations of such evidence safely and securely; (3)
integrate law enforcement, national security, and homeland
security bioforensics requirements; (4) support other Federal
agencies that are responsible for preventing, deterring,
responding to, attributing, and recovering from biological
attacks; (5) develop national standards for bioforensics; (6)
maintain the distributed national bioforensics repository
collection to assist with making forensic comparisons and
identifying biological agents; and (7) support the
characterization of threat agents, as well as research and
development regarding the evaluation of bioforensics laboratory
tests.
This section directs the National Bioforensics Analysis
Center to maintain a national repository collection of
organisms and toxins for bioforensics activities that are not
centralized, but are distributed throughout the country. This
distributed repository collection shall: (1) receive, store,
and distribute biological threat agents and toxins; (2) allow
such organisms and toxins to be compared to those sent to the
Center so that they may be identified and characterized; and
(3) support the characterization of threat agents and the
development of laboratory tests and analyses. In order to
create this distributed repository collection, this section
directs the Secretary of Homeland Security, the Attorney
General, the Secretary of Agriculture, the Secretary of
Defense, the Secretary of Energy, the Secretary of Health and
Human Services, the Director of National Intelligence, and the
head of any other appropriate executive agency with a
collection of organisms or toxins to provide either samples of
or information on these organisms or toxins to this distributed
repository collection.
These samples and information must be useful for: (1)
bioforensics analysis; (2) identification and characterization
of biological agents; and (3) evaluation and development of
laboratory tests and other bioforensics methods. The Secretary
of Homeland Security will determine what organisms and toxins
are relevant for bioforensics, in consultation with the head of
the Federal agency that possesses these organisms or toxins.
The Secretary will also require the samples or information on
organisms or toxins in those public and private sector
collections that were Federally-funded and that the Secretary
determines are relevant for bioforensics. This section directs
the Secretary to provide any Federal agency that has
contributed organisms or toxins to this distributed national
repository collection with access. The Secretary is also
directed to: (1) establish a mechanism to allow other public
and private sector entities access to this collection, as
determined to be appropriate by the Secretary; and (2) ensure
that classified information, law enforcement sensitive
information, and intellectual property rights are protected.
Not later than one year after enactment, and annually
thereafter, the Secretary in consultation with all other
agencies that contribute specimens or information to the
distributed repository collection will submit a report on the
collection to the appropriate committees of Congress.
This section directs the Secretary of Homeland Security, in
coordination with the Attorney General, the Secretary of
Agriculture, Secretary of Defense, the Secretary of Health and
Human Services, the Director of National Intelligence, and the
heads of other appropriate Federal Departments and agencies (as
determined by the Secretary), to develop, coordinate, and
maintain a national bioforensics strategy to increase national
bioforensics capabilities in a coordinated fashion across the
Federal government. The strategy will include: (1) guidance for
sample collection, processing, and analysis; (2) reporting
requirements; and (3) requirements for the distributed
bioforensics repository collection. Not later than one year
after enactment and biennially thereafter, the Secretary, in
consultation with the Attorney General, the Secretary of
Agriculture, the Secretary of Defense, the Secretary of Health
and Human Services, the Director of National Intelligence, and
the heads of other appropriate agencies (as determined by the
Secretary), shall submit the national bioforensics strategy to
the appropriate committees of Congress.
This section also directs the Secretary, in coordination
with the Attorney General and the heads of any other
appropriate Federal agencies, to ensure that a detailed concept
of operations for information sharing and all-source analysis
supporting timely attribution of biological attacks is
available. Additionally, this section allows the Secretary to
implement a detailee program to detail appropriately cleared
governmental national biosecurity and biodefense stakeholders
on a reimbursable basis to the NBFAC. Lastly, this section
directs the Secretary, in coordination with the Attorney
General and the heads of any other appropriate Federal
agencies, to establish a national-level research and
development strategy and implementation plan to advance the
field of bioforensics.
The Committee intends to authorize the existing NBFAC
within the Science and Technology Directorate of the Department
of Homeland Security. The Committee is aware that activities
envisioned for the NBFAC have not occurred according to
schedule. The Committee believes delays have occurred at least
in part because the NBFAC has not benefited from an overarching
national strategy that would indicate how the NBFAC fits with
and supports other governmental bioforensics activities. The
Committee intends for the Federal members of the homeland
security, intelligence, and defense communities that conduct
bioforensics activities to: (1) work together to develop the
national bioforensics strategy and (2) clearly identify roles,
responsibilities, possibilities for transfer of technologies,
and sharing of specimen-related information.
The Committee intends for the national bioforensics
repository collection to be distributed and not entirely
centralized. The Committee intends for either physical
specimens or information/data regarding specimens that would
have utility for bioforensics purposes to compose the national
bioforensics repository collection. Such a dispersed collection
would take advantage of imaging and other technologies and
would reduce the security risks associated with housing all
specimens in one centralized, identifiable location. The
Committee intends for information about and specimens contained
within the repository to be accessible to all contributors, as
the Secretary of Homeland Security deems appropriate.
The Committee intends for the detailees to the NBFAC to
assist the Department of Homeland Security in establishing
sound bioforensic scientific practices, and to better align its
activities with those in the broader scientific community.
Considering that many of the potential specimens that could be
considered part of the distributed national bioforensics
repository collection are found throughout the United States
government, the Committee believes that such detailees could
provide critical insights and more realistic perspectives on
establishing the collection. Additionally, the Committee
believes that such detailees could help to build the
relationships necessary for the NBFAC to carry out its job
efficiently and effectively.
Section 2142. Federal Law Enforcement Training to Investigate
Biological Threats.
This section directs the Secretary of Homeland Security, in
coordination with the Attorney General, the Secretary of
Agriculture, the Secretary of Health and Human Services, and
the heads of other appropriate Federal Departments and
agencies, to make training, tactics, and techniques available
to law enforcement, public health, and security personnel at
the Federal Law Enforcement Training Center (FLETC) for
recognizing and responding to situations involving potential
biological threats, including the performance of coordinated
joint criminal and epidemiological investigations.
The Committee intends to authorize these already existing
training activities within FLETC. The Committee urges FLETC to
learn from other similar, related, and applicable training
activities already occurring at the Federal Bureau of
Investigation, the Department of Health and Human Services, and
other Federal Departments and agencies.
Subtitle E--Response
Section 2151. First Responder Guidance Concerning Weapons of
Mass Destruction Attacks.
This section directs the Secretary of Homeland Security (in
consultation with the heads of appropriate Federal Departments
and agencies, the National Advisory Council, the National
Domestic Preparedness Consortium, State, local, and tribal
authorities, nongovernmental organizations, and private
industry, and reviewing the experiences of other countries and
the expertise of academic institutions and nongovernmental
organizations) to develop voluntary guidance for first
responders and first providers on responding to releases of
chemical, biological, radiological, or nuclear material. This
section also directs the Secretary of Homeland Security to make
this guidance available to government and nongovernmental
organizations, the private sector, and the public. This
guidance shall address: (1) protective actions for first
responders and first providers; (2) the effects of chemical,
biological, radiological, or nuclear material on those exposed
to these agents; and (3) best practices for first responders
and first providers to effectively deal with affected
individuals.
At least every two years, this section directs the
Secretary of Homeland Security to: (1) periodically review this
guidance; (2) make revisions, as appropriate; and (3) make
revised guidance available to government and nongovernmental
organizations, the private sector, and the public. In carrying
out the requirements of this section, the Secretary of Homeland
Security shall: (1) inventory existing relevant HAZMAT response
guidance; (2) enable first responders and first providers to
recommend areas in which guidance is still needed; (3)
determine who should be consulted; (4) regularly prioritize
which guidance should be developed or revised; and (5) develop
and disseminate the guidance.
Not later than 18 months after enactment and annually
thereafter, this section directs the Secretary to provide the
appropriate congressional committees with: (1) a description of
established procedures; (2) any guidance in effect; (3) a list
of entities to which the guidance was disseminated; (4) a plan
for reviewing the guidance; (5) guidance and methodology used
by the Secretary for prioritization; and (6) a plan for
developing, revising and disseminating the guidance.
The Committee intends for the Department of Homeland
Security to provide needed guidance to the first responder and
first provider communities, as well as others that will be
responding to WMD and terrorist attacks involving WMD agents.
The Committee urges the Department of Homeland Security to
review relevant existing Federal, non-Federal, international,
academic, and non-governmental materials when developing the
guidance to be issued under this section. The Committee also
intends for the Department of Homeland Security to provide
clear mechanisms for the first responder and first provider
communities to identify areas for which they feel they are in
need of guidance (as opposed to the Federal government making
these determinations for them). The Committee believes that
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 response to a
WMD attack or incident.
For the purposes of this legislation, first providers are
considered those personnel who provide immediate medical care
when first at the scene of a chemical, biological,
radiological, or nuclear incident. Such personnel include
trained medical professionals, as well as other emergency
personnel who have received some medical training (such as
police, firefighters, and civilians that have received first
aid and other certified training) but are not considered
medical professionals.
Section 2152. Integrated Plume Modeling for Collective
Response.
This section requires the Secretary of Homeland Security to
acquire, use and disseminate timely plume models that integrate
protective action guidance and other appropriate information
(called ``integrated plume models'') to enable quicker response
to a chemical, biological, radiological, or nuclear attack or
event. This section directs the Secretary to: (1) rapidly
develop and distribute these models to appropriate government
officials to enable immediate response to these types of
incidents; (2) establish mechanisms for appropriate emergency
response officials to disseminate these models to
nongovernmental organizations and the public; (3) assess the
development and dissemination of these models during exercises
administered by the Department of Homeland Security; and (4)
ensure that lessons learned from this assessment are
incorporated into the Department of Homeland Security Lessons
Learned Information Sharing system. Not later than one year
after enactment, and annually thereafter, the Secretary of
Homeland Security shall submit to the appropriate congressional
committees a report regarding: (1) the acquisition, use, and
dissemination of these models; (2) lessons learned from the
assessment of these models; and (3) recommendations for
improving these models, as appropriate.
The Committee recognizes that agencies other than the
Department of Homeland Security (such as the Department of
Energy and the Defense Advanced Research Projects Agency) 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 redo this work. Instead, the
Committee intends for the Department of Homeland Security 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
subsequently.
Subtitle F--Recovery
Section 2161. Recovery and Restoration from a Biological
Attack or Incident Guidance.
This section directs the Secretary of Homeland Security, in
coordination with the Administrator of the Environmental
Protection Agency and in consultation with the Director of the
Occupational Safety and Health Agency, and the Director of the
National Institute for Occupational Safety and Health, to
develop and issue guidance for cleaning and restoring indoor
and outdoor areas that have been affected by a biological
attack or event. These guidelines shall address: (1) what is
acceptable as far as the presence of an organism in a sample
taken from an affected area, after it has been cleaned-up; (2)
standards for effective clean up; (3) standards for people to
safely reoccupy these sites; (4) requirements to make sure that
decontamination procedures used by different organizations
working to clean up the sites do not conflict; (5) use of a
uniform system for tracking costs and performance of clean-up
contractors; (6) personal protection equipment; (7) negative
air pressure in buildings; (8) proper selection and use of
personal protective equipment; (9) air sampling procedures; and
(10) how to develop appropriate health and safety plans for
responders.
At least every two years, the Secretary shall: (1) review
this guidance; (2) make appropriate revisions; and (3) make the
revised guidance available to government and nongovernment
organizations, the private sectors, as the public.
In order to develop and revise this guidance, the Secretary
of Homeland Security shall: (1) inventory any existing relevant
guidance; (2) enable the public to recommend areas for which
they think guidance is needed; (3) determine which entities
should be consulted; (4) prioritize (on a regular basis)
guidance that should be developed or revised; and (5) develop
and disseminate the guidance.
Not later than one year after enactment, this guidance
shall be developed and issued. Not later than one year after
enactment and annually thereafter, the Secretary of Homeland
Security shall provide appropriate congressional committees
with: (1) a description of the procedures established; (2) any
guidance in effect on the date of the report; (3) a list of
entities to which the guidance was disseminated; (4) a plan for
reviewing the guidance; (5) the prioritized list of the
guidance required and the methodology used by the Secretary to
set these priorities; and (6) a plan for developing, revising,
and disseminating the guidelines.
The Committee intends to authorize this already existing
activity within the Science and Technology Directorate of the
Department of Homeland Security, and add additional
requirements to: (1) address clean-up and restoration of
pseudo-internal/outdoor areas, such as subways; (2) 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; (3) establish effective clean up
standards; and (4) establish standards for safe occupancy of
affected sites after they have been cleaned-up. The guidance
should be straight-forward and sufficiently detailed to help
local officials restore their communities and ensure that
affected areas are appropriately sampled, assessed,
characterized, and cleaned.
Section 202. Definitions.
The following terms are defined in this section: (1)
``weapon of mass destruction''; (2) ``Intelligence Community'';
``national biosecurity and biodefense stakeholders''; and (3)
``Tier 1 Material Threat Agent.''
Section 203. Dual-Use Terrorist Risks from Synthetic
Genomics.
This section directs the Secretary of Homeland Security,
acting through the Under Secretary for Science and Technology,
to examine and report within a year from enactment on the
homeland security implications of the dual-use nature of
synthetic genomics and, if the Under Secretary determines that
research into this area is appropriate, to conduct research in
this area. This research will: (1) determine the current
capability of providers of synthetic nucleic acids to
effectively differentiate between legitimate customers and
potential terrorists or other malicious actors; (2) determine
the current capability of synthetic nucleic acid providers to
effectively screen orders for sequences of homeland security
concern; and (3) make recommendations regarding capability gaps
uncovered by the study.
The field of synthetic genomics has the potential to
facilitate enormous gains in fundamental discovery and
biotechnological applications, but it also has inherent dual-
use homeland security risks that must be managed. 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.
Section 204. Dissemination of Information Analyzed by the
Department to State, Local, Tribal, and Private Entities with
Responsibilities Relating to Homeland Security.
This section expands the list of entities in section
201(d)(8) of the Homeland Security Act of 2002 to which the
Department of Homeland Security 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, and
responding to acts of terrorism against the United States. Not
later than one year after enactment, the Secretary of Homeland
Security shall submit a report to the appropriate congressional
committees on the implementation of this section.
The Committee intends for the Department of Homeland
Security to disseminate information to State, local, tribal,
and private sector entities with homeland security
responsibilities, and as appropriate to the public. The
Committee intends for the Department of Homeland Security to
prioritize the goals of preventing, deterring, and responding
to acts of terrorism against the United States in mind
regarding needed information, and for the Department of
Homeland Security to report on its activities in this regard.
Section 205. National Biosurveillance Integration Center
(NBIC).
This section moves the NBIC to the Office of Intelligence
and Analysis at the Department of Homeland Security (and out of
the Department of Homeland Security Office of Health Affairs)
and directs participating Federal Departments and agencies to
detail personnel to the Department of Homeland Security on a
reimbursable basis. Not later than one year after enactment,
and annually thereafter, the Secretary shall submit to the
appropriate congressional committees an interim report on the:
(1) status of NBIC; (2) efforts of the Office of Intelligence
and Analysis to take responsibility for NBIC; and (3) efforts
to integrate the surveillance efforts of Federal, State, local,
and tribal governments.
The Committee is disappointed that the Department of
Homeland Security has been unable to secure participation in
the NBIC by other necessary Federal partners. The Committee
intends to improve Federal participation by mandating both
their participation and reimbursement for the costs of their
participation by the Department of Homeland Security. The
Committee believes that by moving the NBIC operation to the
Office of Intelligence and Analysis, the Center will have the
opportunity to leverage existing channels for exchange of
information with governmental and non-governmental partners, as
exist within the Office of Intelligence and Analysis. The
Committee also believes that the NBIC would benefit from
exposure to the intelligence activities in the Office of
Intelligence and Analysis regarding the biological threat.
Section 206. Report on Establishment of the System Assessment
and Validation for Emergency Responders (SAVER) Program.
This section directs the Secretary of Homeland Security to
submit a report to the appropriate congressional committees on
the SAVER program (see section 2134 above) not later than one
year after enactment.
Section 207. National Academy of Sciences Study of Forensic
Science in Homeland Security.
This section directs the Secretary of Homeland Security,
acting through the Under Secretary for Science and Technology,
to enter into an agreement (no later than 90 days after
enactment) with the National Academy of Sciences. This
agreement will be for the National Academy of Sciences to
undertake a study on the role of forensic science in homeland
security and to issue appropriate recommendations to enhance
this capability to investigate WMD attacks, terrorist
incidents, and other crimes investigated by the Department of
Homeland Security. Not later than two years after enactment,
the Secretary shall submit a report containing the results of
the study, together with any recommendations from the
Secretary. There is authorized to be appropriated $1,000,000 to
the Department of Homeland Security for fiscal year 2011 to
carry out this section.
The Committee recognizes the National Academy of Sciences'
previous work in studying forensic science and is aware of its
2009 report on forensics. The Committee intends for the
National Academy of Sciences to undertake a comprehensive study
of forensics in furtherance of the Department of Homeland
Security law enforcement activities conducted by U.S.
Immigration and Customs and Enforcement, the U.S. Secret
Service, and other law enforcement agencies and agencies with
law enforcement elements that conduct investigations with
homeland security implications. Additionally, the Committee
intends for the National Academy of Sciences to address
forensics for WMD and acts of terrorism using other types of
agents. The Committee intends for the National Academy of
Sciences to also study forensics that are used by other Federal
agencies (e.g., the Department of Defense and the Intelligence
Community) for homeland security purposes. The Committee
intends for the National Academy of Sciences to pay particular
attention to bioforensics for homeland security and national
security purposes used by the homeland security, intelligence,
and defense communities.
Section 208. Harmonization of Regulations.
This section harmonizes regulations in the Homeland
Security Act of 2002, the Public Health Service Act, and the
Agricultural Bioterrorism Protection Action of 2002 to ensure
that such regulations are not redundant or in conflict with the
regulations promulgated under section 2104 (see above).
The Committee does not intend for new regulations put
forward by the WMD Prevention and Preparedness Act of 2010 to
be redundant or conflict with regulations in the Public Health
Service Act or the Agricultural Bioterrorism Protection Act of
2002.
Section 209. Communications Planning for Weapons of Mass
Destruction Information Dissemination.
This section directs the Secretary, acting through the
Administrator of the Federal Emergency Management Agency (in
consultation with State, local, and tribal authorities and in
coordination with other Federal Departments and agencies, as
appropriate) to develop a communications plan for providing
information to the public on preventing, preparing for, and
responding to attacks with WMD and acts of terrorism. This
section directs the Administrator of the Federal Emergency
Management Agency to incorporate this plan into Federal
Emergency Management Agency operational plans.
This section also directs the Administrator of the Federal
Emergency Management Agency to develop pre-scripted messages
and message templates (in consultation with State, local, and
tribal authorities and in coordination with other Federal
Departments and agencies, as appropriate) and disseminate them
to State, local, and tribal authorities so that they can
incorporate them into their own emergency plans, and quickly
disseminate critical information to the public in anticipation
of or immediately after a WMD or terrorist incident. These pre-
scripted messages and message templates will also be
incorporated into the National Exercise Program, included in
the Department of Homeland Security Lessons Learned Information
Sharing system, and issued in multiple formats. Not later than
one year after enactment, the Administrator shall submit to the
appropriate congressional committees the communications plans
required to be developed under this section (including the pre-
scripted messages or message templates) and a description of
how they will be used to deliver these messages.
The Committee intends for the Federal Emergency Management
Agency to disseminate as much information as possible in
advance by developing pre-scripted messages and message
templates, and disseminating these to State, local, and tribal
authorities, so that they can plan in advance as well.
Section 210. Environmental Recovery from Chemical,
Biological, Radiological, and Nuclear Attacks.
This section directs the Administrator of the Environmental
Protection Agency, in coordination with the Administrator of
the Federal Emergency Management Agency, to: (1) assess
capability gaps in preparedness for environmental recovery from
chemical, biological, radiological, and nuclear attacks; (2)
provide guidance to State, local, and tribal authorities for
such recovery; and (3) develop exercises that enhance
collective response to and recovery from such attacks. No later
than one year after enactment, the Administrator of the
Environmental Protection Agency shall submit to the appropriate
congressional committees a report on the Administrator's
assessment (see section 2162 above).
The Committee intends to identify the Environmental
Protection Agency as the lead agency to accomplish this
mission, and provides clear requirements for its
responsibilities in this regard. Although the Committee
recognizes the challenges inherent in addressing environmental
recovery requirements, the Committee believes that there is a
great need for the Environmental Protection Agency to establish
such requirements.
Section 211. University-Based Centers for Homeland Security
Criteria for Designation.
This section adds additional clarifying criteria to that
used to designate university-based centers for homeland
security. This section states that demonstrated expertise in
emergency and diagnostic medical services shall include: (1)
medical readiness training and research; and (2) community
resiliency for public health and healthcare critical
infrastructure.
The Committee intends to ensure that universities that have
demonstrated expertise in medical readiness training and
research, and community resiliency for public health and
healthcare critical infrastructure, are able to seek
designation as university-based centers for homeland security.
The Committee encourages universities with this demonstrated
expertise to seek such designation.
TITLE III--PUBLIC HEALTH MATTERS
Section 301. National Medical Countermeasure Dispensing
Strategy.
This section directs 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 Departments and agencies, to develop,
implement, and update periodically a National Medical
Countermeasure Dispensing Strategy to help prepare for and
collectively respond to a terrorist attack on humans or animals
with chemical, biological, radiological, or nuclear agents.
This section directs the Secretary of Health and Human Services
to coordinate with State, local, tribal, and nongovernmental
organizations on this Strategy. Not later than one year after
enactment, the Secretary of Health and Human Services, in
coordination with the Secretary of Homeland Security, shall
submit the National Medical Countermeasures Dispensing Strategy
to the appropriate congressional committees.
The Committee recognizes that the Department of Health and
Human Services has been developing medical countermeasures, and
has addressed medical countermeasures to a limited extent in
the National Health Security Strategy. The Committee intends
for the Department of Health and Human Services to give
enhanced focus to developing a strategy for dispensing medical
countermeasures, and to work with other Federal Departments and
agencies to develop the National Medical Countermeasure
Strategy. That detailed strategy should include an
implementation plan and be adaptable to the needs of a local
jurisdiction. The Committee believes that the strategy and
implementation plan be developed in a manner that is closely
aligned with ongoing work in the area by the Secretary. The
Secretary is encouraged to seek input on the strategy from
State and local public health officials.
Section 302. Material Threat Assessments and Determinations.
Recognizing the evolving nature of the threat, advances in
technology, and changing priorities, this section amends the
BioShield Act to require 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, affecting homeland security and national security.
The Committee recognizes that some agents pose material
threats to the Nation; it acknowledges, however, the
possibility that these agents may not always pose materials
threats to the Nation or the same material threats over time.
Congress has authorized the Department of Homeland Security to
assess various agents and to determine whether they are
material threats to the United States. 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 material threats to the Nation.
Additionally, the Committee intends for these decisions to be
made in light of availability of medical and other
countermeasures, new science and technologies, immunization
rates, and other relevant factors.
Section 303. National Pre-Event Vaccination and Antimicrobial
Dispensing Policy Review.
This section directs the Secretary of Health and Human
Services, in coordination with the Secretary of Homeland
Security, to determine whether domestic vaccination policy,
policy regarding the dispensing of antibiotics and other
antimicrobials, as well as related guidance and information
provided to the public are adequate, taking into consideration
known terrorist risks of biological attacks or events with
significant health consequences to the United States. In
carrying out this review, the Secretary shall consider the
following: (1) material threat assessments and determinations
conducted by the Department of Homeland Security; (2) global
trends identified by the Intelligence Community regarding the
biological threat; (3) availability of vaccine and
antimicrobials, and recommendations relating to voluntarily
getting immunized and keeping a personal store of
antimicrobials in advance of biological attacks or events with
significant health consequences; and (4) making surplus or
expiring vaccine and antimicrobials available to first
responders. Not later than one year after enactment, the
Secretary of Health and Human Services shall submit this review
to the appropriate congressional committees, with any
recommendations relating to the availability of domestic
vaccine and antimicrobials to give to the public, as well as
voluntary immunization of first responders.
The Committee notes that current vaccination policy varies
according to threats from specific agents and does not require
that vaccines that could prevent horrific diseases (e.g.,
smallpox) be provided on a mandatory or voluntary basis in
advance of the terrorist use of biological agents. For purposes
of this Act, the Committee believes that vaccination policy
should align with material threat determinations. If certain
biological agents pose material threats to the United States,
then different policies may be needed (e.g., policy may change
to allow first responders to be immunized against these agents
on a voluntary basis, or to allow expiring or surplus vaccines
and antimicrobials to be released from the national stockpile
for more immediate use).
In carrying out this section, the Departments of Health and
Human Services and Homeland Security should take into
consideration the views of public health, public safety, and
homeland security experts in the course of conducting this
examination of vaccination and antimicrobial dispensing
practices. The Committee also intends for this examination to
specifically address (in addition to other issues deemed
important by the Secretary of Health and Human Services and the
Secretary of the Homeland Security) 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 these expiring
medicines.
Section 304. Designation of Tier 1 Material Threat Agents.
This section directs the Secretaries of Agriculture and
Health and Human Services, in coordination with the Secretary
of Homeland Security and the heads of other appropriate Federal
Departments and agencies, to issue regulations to create a top
tier of Select Agents that are considered material threats to
the United States (Tier 1 Material Threat Agents), and
therefore require additional security. These Tier 1 Material
Threat Agents will be designated as such no later than one year
after enactment. Criteria for designation include: (1) whether
the agent or toxin can be used effectively in a biological
attack; (2) information available from biological or
bioterrorism risk assessments; and (3) other criteria and
information that the Secretary of Health and Human Services, in
coordination with the Secretary of Homeland Security,
determines are appropriate and relevant. All Tier 1 Material
Threat Agents will be added to the Select Agents list, if they
are not already there.
This section also directs the Secretary of Agriculture and
the Secretary of Health and Human Services, in coordination
with the Secretary of Homeland Security, to consider whether
other agents should be designated Tier 1 Material Threat agents
on an ongoing basis. The Secretaries will also biennially
consider whether agents should be removed from the list of Tier
1 Material Threat agents.
The Committee believes that agents in this tier (such as
smallpox) must be secured at the highest levels. The Committee
recognizes that these agents are both Select Agents (having the
potential to cause significant amounts of illness and death)
and considered to be material threats to the United States
(having been weaponized for military purposes, having had state
and/or non-state actors attempt to obtain them, and so forth).
The Committee believes that it is imperative that we not allow
terrorists and other criminals to access these particular
agents.
In carrying out this section, the Committee intends for the
Tier 1 Material Threat list to be developed with great focus to
ensure that the number of material threats is appropriately
limited. The Committee recognizes that the Select Agent Program
carries with it significant biosafety and laboratory security
requirements to begin with, so there is no need to have a large
number of Tier 1 Material Threat Agents. The Committee urges
the Department of Homeland Security, the Department of
Agriculture, the Department of Health and Human Services, and
other appropriate Federal Departments and agencies that make or
inform these determinations to ensure that this list contains
only those agents that must be represented, and to periodically
remove agents from the list, as appropriate.
Section 305. Background Checks.
This section directs 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 knowing
involvement with an organization that engages in domestic or
international terrorism or with any other organization that
engages in crimes of violence. In requiring interagency
coordination and exchange of information: (1) these Federal
Departments may not have to duplicate background
investigations; (2) personnel who should not be working with
Select Agents may be more quickly identified; and (3) it will
be that much more difficult for malevolent actors to gain
access to Select Agents in general, and Tier 1 Material Threat
Agents specifically.
The Committee intends for Federal agencies to share
information on individuals that should not be provided access
to Select Agents, 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.
Section 306. Biotechnology Research, Development, and
Procurement.
This section directs the Secretary of Health and Human
Services to develop a comprehensive research, development, and
acquisition process to counter the biological threat. This
process will link the activities of the National Institutes of
Health, the Biodefense Advanced Research and Development
Authority, and the Project BioShield Special Reserve Fund. The
process shall clearly make: (1) the National Institutes of
Health responsible for basic research to development of models
and prototypes; (2) the Biodefense Advanced Research and
Development Authority responsible for development of models and
prototypes to demonstrate that the systems work; and (3) the
Project BioShield Special Reserve Fund responsible for
procuring technologies that have been demonstrated to work and
that meet the requirements for emergency use authorization.
There is no requirement for General Use Approval by the Food
and Drug Administration.
This section also directs that the National Institutes of
Health, the Biodefense Advanced Research and Development
Authority, and the Project BioShield Special Reserve Fund to
formally agree that: (1) a specific biological countermeasure
is clearly necessary; (2) what the current level of technology
is for that countermeasure; and (3) that the countermeasure
will be procured. Further, this section directs the Director of
the National Institutes of Health, the Biodefense Advanced
Research and Development Authority, and the Assistant Secretary
for Preparedness and Response of the Department of Health and
Human Services to be aggressive in pursuing innovative
research, development, and procurement of these
countermeasures.
The Committee, through its oversight work, has observed
that there is a need for lines of demarcation between the
National Institutes of Health, the Biomedical Advanced Research
and Development Authority, and the Project BioShield Special
Reserve Fund as to their relative responsibilities regarding
biosecurity research and development. The Committee intends for
clear guidance regarding the roles and responsibilities of the
National Institutes of Health, the Biodefense Advanced Research
and Development Authority, and the Project BioShield Special
Reserve Fund be issued to companies wishing to engage in
technology development. The Committee also intends to create
requirements for the Department of Health and Human Services to
transfer projects from one to the other without creating gaps,
in order to ensure future success in countermeasure development
and procurement.
TITLE IV--FOREIGN RELATIONS MATTERS
Section 401. International Collaboration and Information
Sharing Relating to Biosecurity.
This section directs the Secretary of State, in
coordination with the Secretary of Homeland Security, the
Secretary of Agriculture, the Secretary of Health and Human
Services, and the heads of other appropriate Federal
Departments and agencies, to support efforts in other countries
to: (1) report information regarding biological attacks and
events with significant health consequences to the United
Nations; (2) prevent misuse of life sciences; and (3) promote
greater awareness of how much life science technology is both
available and accessible; and (4) promote the development of
mechanisms to report, preserve, and share data regarding
Federal activities to collaborate and enhance global
biosecurity.
The Committee intends for the United States to support
efforts in other countries to increase biosecurity throughout
the world, recognizing that: (1) diseases spread across
borders; (2) biological weapons are proliferating overseas; and
(3) lack of laboratory security could result in thefts and
accidents that could in turn affect other countries, including
the United States
Section 402. International Engagement to Enhance Biodefense
and Biosecurity.
This section directs the Secretary of State, in
coordination and consultation with the Secretary of Homeland
Security and the heads of other appropriate Federal Departments
and agencies, to address biosecurity in the international
arena, to: (1) support other countries as they work to
criminalize bioterrorism and the development and use of
biological weapons; (2) engage international governmental and
nongovernmental partners in developing and establishing common
standards, guidance, and best practices to prevent the illicit
use of life sciences; (3) support the efforts of other
countries to enhance biological security and safety practices
at laboratories that work with dangerous biological materials;
(4) promote the development and adoption of international
guidance regarding the safe handling and security of dangerous
biological materials; and (5) promote the sharing of
information between and among the intelligence, law
enforcement, and security communities.
Section 403. Interagency Task Force on Best Practices for
Global Biopreparedness.
This section expresses the sense of the Committee that
preparedness for chemical, biological, radiological, or nuclear
incidents must be undertaken both domestically and
internationally, and that a global preparedness architecture is
necessary for such events. This section also directs the
Secretary of State to convene and lead an interagency task
force to examine: (1) how prepared the world is for a major
biological event; (2) the necessary elements of this
architecture; (3) best practices for preparedness based on
lessons learned from domestic efforts that may be applicable
internationally; (4) relevant activities, including but not
limited to those directed by the National Strategy for
Countering Biological Threats and the International Health
Regulations of 2005; and (5) whether existing international
forums can distribute relevant information to the global
community. The task force shall include representatives from
the Department of Homeland Security, the Department of
Agriculture, the Department of Defense, the Department of
Health and Human Services, the Department of Justice, the
Department of State, the United States Agency for International
Development, and the Office of the Director of National
Intelligence. Other Federal Departments and agencies, and other
national biosecurity and biodefense stakeholders, including
State and local public health and law enforcement officials,
may also be members of the task force, as the Secretary
determines they are appropriate. No later than 18 months after
enactment, the Secretary shall submit a report regarding task
force findings to the appropriate congressional committees.
The Committee recognizes that the United States is ahead of
many nations with respect to efforts to prevent, deter, prepare
for, detect, attribute, respond to, and recover from WMD
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, without compromising homeland and national
security.
Section 404. Biological and Toxin Weapons Convention (BWC).
This section directs the Secretary of State to promote the
Biological and Toxin Weapons Convention (BWC) by promoting
transparency, pursuing compliance diplomatically, promoting
universal BWC membership, developing an action plan for
increasing international adherence to the BWC, and ensuring
that United States participation in BWC meetings is broadly
inclusive of representatives from all of its relevant Federal
Departments and agencies.
The Committee believes that the United States should
support and promote the BWC. The Committee intends for the
leadership role of the Department of State to be strengthened
in this regard.
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) Short Title.--This Act may be cited as the ``Homeland
Security Act of 2002''.
(b) Table of Contents.--The table of contents for this Act is
as follows:
Sec. 1. Short title; table of contents.
* * * * * * *
TITLE XXI--WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS
Subtitle A--Prevention and Deterrence
Sec. 2101. Weapons of Mass Destruction Intelligence and Information
Sharing Unit.
Sec. 2102. Information sharing and collaboration for biosecurity and
biodefense.
Sec. 2103. Bioterrorism risk assessments.
Sec. 2104. Radiological materials security.
Sec. 2105. Enhanced biosecurity measures.
Sec. 2106. Tier I Material Threat Agent locations.
Sec. 2107. High containment biological laboratory security grants.
Sec. 2108. Laboratory biosecurity information sharing.
Sec. 2109. Periodic homeland security review of criminal statutes.
Sec. 2110. Export enforcement for counter-proliferation.
Subtitle B--Preparedness
Sec. 2121. Communication of threat information and alerts.
Sec. 2122. Individual and community preparedness for weapons of mass
destruction.
Subtitle C--Detection
Sec. 2131. National biosurveillance strategy.
Sec. 2132. Detection of biological attacks.
Sec. 2133. Rapid biological threat detection and identification.
Sec. 2134. Establishment of the system assessment and validation for
emergency responders (SAVER) program.
Sec. 2135. Payment for bioterrorism laboratory services.
Sec. 2136. Establishment of the integrated consortium of laboratory
networks.
Subtitle D--Attribution
Sec. 2141. Bioforensics capabilities and strategy.
Sec. 2142. Federal law enforcement training to investigate biological
threats.
Subtitle E--Response
Sec. 2151. First responder guidance concerning weapons of mass
destruction attacks.
Sec. 2152. Integrated plume modeling for collective response.
Subtitle F--Recovery
Sec. 2161. Recovery and restoration from a biological attack or incident
guidance.
* * * * * * *
SEC. 2. DEFINITIONS.
* * * * * * *
(19) The term ``weapon of mass destruction'' has the
meaning given that term in section 1403(1) of the
Defense Against Weapons of Mass Destruction Act of 1996
(50 U.S.C. 2302).
(20) 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)).
(21) 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,
deter, prepare for, detect, attribute, respond, 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.
(22) The term ``Tier I Material Threat Agent'' means
a substance so designated under section 351A(a)(2) of
the Public Health Service Act or section 212(a)(2) of
the Agricultural Bioterrorism Protection Act of 2002.
* * * * * * *
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. 308. CONDUCT OF RESEARCH, DEVELOPMENT, DEMONSTRATION, TESTING AND
EVALUATION.
(a) * * *
(b) Extramural Programs.--
(1) * * *
(2) University-based centers for homeland security.--
(A) * * *
(B) Criteria for designation.--Criteria for
the designation of colleges or universities as
a center for homeland security, shall include,
but are not limited to, demonstrated expertise
in--
(i) * * *
* * * * * * *
(iii) Emergency and diagnostic
medical services, including medical
readiness training and research, and
community resiliency for public health
and healthcare critical infrastructure.
* * * * * * *
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.] the Office of Intelligence and
Analysis.
* * * * * * *
(d) Responsibilities of the Directing Officer of the NBIC.--
(1) * * *
(2) Assessments.--The Directing Officer of the NBIC
shall--
(A) * * *
(B) integrate and disseminate homeland
security information, including information and
intelligence generated elsewhere within the
Office of Intelligence and Analysis and the
Department, with NBIC data to provide overall
situational awareness and determine whether a
biological event of national concern has
occurred.
* * * * * * *
(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;]
(A) integrate biosurveillance information
into the NBIC, with the goal of promoting
information sharing between Federal, State,
local, and tribal authorities to detect
biological attacks and events of homeland
concern;
* * * * * * *
(f) Administrative Authorities.--
(1) * * *
[(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.]
(2) Detail of personnel.--The head of a participating
Federal department or agency shall 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.
* * * * * * *
(j) Annual Report.--Not later than one year after the date of
the enactment of the WMD Prevention and Preparedness Act of
2010 and annually thereafter, the Secretary shall submit to the
appropriate congressional committees a report on--
(1) the status of operations at the National
Biosurveillance Integration Center of the Department
under section 316;
(2) efforts by the Office of Intelligence and
Analysis to take responsibility for the National
Biosurveillance Integration Center; and
(3) efforts to integrate the biosurveillance efforts
of Federal, State, local, and tribal authorities.
[(j)] (k) Definitions.--In this section:
(1) * * *
* * * * * * *
TITLE XXI--WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS
Subtitle A--Prevention and Deterrence
SEC. 2101. WEAPONS OF MASS DESTRUCTION INTELLIGENCE AND INFORMATION
SHARING UNIT.
(a) In General.--There is established in the Office of
Intelligence and Analysis of the Department a unit for weapons
of mass destruction intelligence and information sharing. The
unit shall conduct intelligence and information sharing
activities consistent with the National Intelligence Strategy
for Countering the Threat from Weapons of Mass Destruction
under section 101 of the WMD Prevention and Preparedness Act of
2010 and the National Intelligence Strategy for Countering
Biological Threats under section 102 of that Act and shall--
(1) evaluate and establish a baseline of terrorist
actors, their claims, and their plans to conduct
attacks involving chemical, biological, radiological,
and nuclear materials against the Nation;
(2) support homeland security-focused intelligence
analysis of global infectious disease, public health,
food, agricultural, and veterinary issues;
(3) provide tailored analytical support on these
threats to State, local, and tribal authorities as well
as members of the public health, scientific, and
response communities; and
(4) perform other responsibilities, as assigned by
the Secretary.
(b) Coordination.--Where appropriate, the unit shall
coordinate with others in the Intelligence Community, including
the National Counter Proliferation Center.
(c) Report.--Not later than one year after the date of the
enactment of this section and annually thereafter, the
Secretary shall report to the appropriate congressional
committees on the intelligence and information sharing
activities of the unit for weapons of mass destruction
intelligence and information sharing established under
subsection (a) and all relevant entities within the Department
to counter the threat from weapons of mass destruction and how
the Department acted 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.
SEC. 2102. INFORMATION SHARING AND COLLABORATION FOR BIOSECURITY AND
BIODEFENSE.
(a) Responsibilities of Secretary of Homeland Security.--To
increase situational awareness, the Secretary, acting through
the Under Secretary for Intelligence and Analysis, shall--
(1) to the greatest extent practicable, integrate
into the homeland security, intelligence, and
information sharing process national biosecurity and
biodefense stakeholders;
(2) develop an information sharing framework for
homeland security intelligence and information sharing
withe national biosecurity and biodefense stakeholders;
(3) enable national biosecurity and biodefense
stakeholders to provide recommendations with respect to
the development of mechanisms and protocols to
integrate information from national biosecurity and
biodefense stakeholders;
(4) leverage existing and emerging homeland security
capabilities and structures, including fusion centers
established pursuant to section 210A, to enhance
prevention, detection, preparedness, and collective
response, attribution, and recovery efforts of 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; and
(5) advance partnerships between the Department and
other Federal departments and agencies in assessing
potential threats and the risks from the intentional
use of biological agents by terrorists or other actors.
(b) Coordination With Other Departments and Agencies.--The
Secretary shall work in coordination with the Secretary of
State, the Secretary of Agriculture, the Secretary of Health
and Human Services, and the heads of other appropriate Federal
agencies.
SEC. 2103. BIOTERRORISM RISK ASSESSMENTS.
(a) Risk Assessment.--The Secretary, in coordination with the
heads of other appropriate Federal departments and agencies,
shall produce biennial integrated risk assessments, to be known
as ``Bioterrorism Risk Assessments'' to identify and assess the
evolving 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. These assessments shall--
(1) identify the threat, vulnerability, and
consequences of a biological terrorist attack against
the United States;
(2) take into account intelligence and information
regarding terrorist intentions, capabilities, plans,
and actions;
(3) be used to inform and guide threat assessments
and determinations made by the Secretary regarding
agents and toxins pursuant to section 302(9), and to
guide prioritization of other homeland security
activities, as appropriate;
(4) provide the basis for risk-informed investments
in national strategic biodefense research, development,
planning, preparedness, and collective response to
biological attacks;
(5) identify key knowledge and data gaps;
(6) define critical biodefense vulnerabilities;
(7) provide risk-based prioritization of agents for
bioterrorism; and
(8) evaluate progress in implementing national
biopreparedness policy.
(b) Requirement.--The Secretary shall--
(1) convene an interagency task force of subject
matter experts to provide recommendations to the Under
Secretary for Science and Technology as to the adequacy
of the methodology used in the Assessments and to
establish requirements and standards for the
Assessments;
(2) engage with national biosecurity and biodefense
stakeholders to obtain their input regarding the
Assessments, as appropriate; and
(3) ensure, to the greatest extent practicable, that
the Assessments inform the risk management decisions of
the Department and can be made available to national
biosecurity and biodefense stakeholders, as
appropriate.
SEC. 2104. RADIOLOGICAL MATERIALS SECURITY.
(a) Risk Assessment.--The Secretary shall enhance domestic
preparedness for and collective response to terrorism by
conducting annual risk assessments regarding the threat,
vulnerability, and consequences of theft or other procurement
of radiological materials that could be used by a terrorist in
a radiological dispersion device, including any specific threat
information pertinent to the use of radiological materials in a
possible terrorist attack using a radiological dispersion
device.
(b) Considerations.--In conducting the terrorism risk
assessments under subsection (a), the Secretary shall--
(1) consult with Secretary of Energy, Secretary of
Heath and Human Services, and the Nuclear Regulatory
Commission;
(2) consider relevant studies previously prepared by
other Federal agencies, or other reputable sources;
(3) focus on those radiological materials that
constitute the greatest risk, and designate those
materials as high-risk radiological materials for
purposes of this section;
(4) consider the potential radiological dispersion
device value of different radiological materials
including availability, dispersability, and ease of
handling of such materials;
(5) consider the vulnerability for theft or other
procurement that different facilities represent; and
(6) consider the consequences of a successful
radiological dispersion device attack, including risk
of death or injury and economic losses.
(c) Consultation.--In conducting the terrorism risk
assessments under subsection (a), the Secretary shall consult
with the Intelligence Community, the Secretary of Energy and
the Field Intelligence Elements of the National Laboratories,
and the Nuclear Regulatory Commission, the Secretary of Health
and Human Services, and other appropriate experts to integrate
and analyze information needed to develop the risk assessment.
(d) Dissemination of Findings.--The Secretary shall
disseminate the findings of the risk assessments and any
specific risk information developed in the assessment to all
participating agencies including those described in subsection
(c), as well State and local agencies, and the facilities
containing radiological source material and regulated by the
Nuclear Regulatory Commission.
(e) Classification.--The Secretary shall, as appropriate,
share the terrorism risk assessments with law enforcement and
critical infrastructure operators with appropriate security
clearances. The Secretary shall also make available an
unclassified version to each agency with which the Secretary is
required to consult under subsection (c), as well as State and
local law enforcement and public health authorities, and
facilities possessing radiological materials with the support
of the Department of Energy.
SEC. 2105. ENHANCED BIOSECURITY MEASURES.
(a) Regulations.--At the request of the Secretary, the
Secretary, in consultation with the Secretary of Agriculture,
the Secretary of Health and Human Services, and the heads of
other appropriate Federal agencies, shall, through a negotiated
rulemaking committee under subchapter III of chapter 5 of title
5, United States Code, establish enhanced biosecurity measures
for persons or laboratories that possess, use, or transfer Tier
I Material Threat Agents. Such measures shall include--
(1) standards for personnel surety programs;
(2) standards for biosecurity practices and training
of responsible officials, laboratory personnel, and
support personnel;
(3) standards for performing laboratory vulnerability
assessments in collaboration with each facility;
(4) risk-based laboratory security performance
standards;
(5) penalties (including civil money penalties and
intermediate sanctions), in addition to any other
penalties that may apply under provisions of law; and
(6) any other security standards determined necessary
by the Secretary, the Secretary of Agriculture,
Secretary of Health and Human Services, and other
agencies as appropriate.
(b) Negotiated Rulemaking Committee.--The Secretary shall
establish a negotiated rulemaking committee for purposes of
subsection (a). Such committee shall include a representative
from each of the following:
(1) The Department.
(2) The Department of Health and Human Services.
(3) The Department of Agriculture.
(4) The Department of Defense.
(5) The Department of Energy.
(6) The Department of Justice.
(7) For-profit research institutions.
(8) Academic research institutions.
(9) Nonprofit research institutions
(10) Other stakeholders, as the Secretary determines
appropriate.
(c) Time Requirement.--The procedures for the negotiated
rulemaking referred to in subsection (a) shall be conducted in
a timely manner to ensure that--
(1) any recommendations with respect to proposed
regulations are provided to the Secretary and the heads
of the other appropriate Federal agencies not later
than one year after the date of the enactment of this
section; and
(2) a final rule is promulgated not later than two
years after the date of the enactment of this section.
(d) Factors To Be Considered.--In developing proposed and
final standards pursuant to the negotiated rulemaking referred
to in subsection (a), the negotiated rulemaking committee shall
consider--
(1) the Commission on the Prevention of Weapons of
Mass Destruction Proliferation and Terrorism
(established under section 1851 of the Implementing
Recommendations of the 9/11 Commission Act of 2007
(Public Law 110-53; 121 Stat. 501));
(2) the National Science Advisory Board for
Biosecurity (established under section 217a of title
42, United States Code, section 222 of the Public
Health Service Act, and section 205 of the Pandemic and
All-Hazards Preparedness Act);
(3) any working group established under Executive
Order 13486 (74 Fed. Reg. 2289) relating to
strengthening laboratory biosecurity;
(4) the Chemical Facility Anti-Terrorism Act of 2009;
and
(5) views from representatives of biosecurity and
biodefense stakeholders for methods to minimize any
disincentives to biological research arising from
enhanced biosecurity measures.
(e) Implementation of Enhanced Biosecurity Measures.--
(1) Enforcement.--The Secretary of Agriculture and
the Secretary of Health and Human Services, in
consultation with the Secretary, as appropriate, shall
enforce the measures established under subsection (a)
and any standards promulgated pursuant to such section.
(2) Training programs.--The Secretary of Agriculture
and the Secretary of Health and Human Services, in
coordination with the Secretary and the heads of other
Federal agencies, as appropriate, shall develop
training programs that comply with such measures and
standards.
(3) Procedures.--The Secretary of Agriculture and the
Secretary of Health and Human Services, in consultation
with the Secretary and the heads of other Federal
agencies, as appropriate, shall develop and implement
procedures with respect to when and how penalties and
intermediate sanctions may be imposed. Such procedures
shall provide for notice, a reasonable opportunity to
respond to the proposed penalty or intermediate
sanction, and appropriate procedures for appealing
determinations relating to the imposition of a penalty
or intermediate sanction.
(4) Simultaneous laboratory inspections.--
(A) Inspection data sharing and enforcement
uniformity.--The Secretary of Agriculture and
the Secretary of Health and Human Services
shall periodically provide the Secretary with
all data concerning inspections of laboratories
that handle Tier 1 Material Threat Agents to
ensure uniformity in enforcement of the
regulations enacted under subsection (a) and to
identify areas where the Secretary can provide
guidance to the Secretary of Agriculture or the
Secretary of Health and Human Services about
approaches to enhance security at specific
laboratories.
(B) Simultaneous inspections.--Any
inspections of the same laboratory conducted by
the Secretary of Agriculture pursuant to
section 212(a)(1) of the Agricultural
Bioterrorism Protection Act of 2002 and the
Secretary of Health and Human Services for
compliance with regulations promulgated under
the Select Agent Program under section
351A(a)(1) of the Public Health Service Act,
shall be conducted simultaneously to the extent
practicable.
(C) Common inspection procedures.--
Departments conducting simultaneous inspections
of a laboratory under this subsection shall
ensure, to the maximum extent practicable, that
such inspections are conducted using a common
set of inspection procedures across such
departments in order to minimize the
administrative burden on such laboratory.
(D) Inspection reports.--Inspection reports
generated under this paragraph shall be made
available to each Federal agency that supports
select agent laboratory activities at the
institution that is the subject of the
inspection report, and to the institutions that
are the object of inspections.
SEC. 2106. TIER I MATERIAL THREAT AGENT LOCATIONS.
The Secretary of Agriculture and the Secretary of Health and
Human Services shall provide to the Secretary a list of
laboratories and other locations where Tier I Material Threat
Agents are present in the United States and its territories.
SEC. 2107. HIGH CONTAINMENT BIOLOGICAL LABORATORY SECURITY GRANTS.
(a) Grants Authorized.--The Secretary, acting through the
Administrator of the Federal Emergency Management Agency, may
award grants based on risk to academic and nonprofit
organizations and to State, local, and tribal authorities that
possess, use, or transfer Tier I Material Threat Agents, to
enhance security at laboratories of such organizations and
authorities.
(b) Authorization of Appropriations.--There is authorized to
be appropriated to the Department of Homeland Security to carry
out this subsection $50,000,000 for each of fiscal years 2011
through 2013.
SEC. 2108. LABORATORY BIOSECURITY INFORMATION SHARING.
(a) In General.--Consistent with the responsibilities of the
Secretary under section 201(d), the Secretary shall establish
procedures, with appropriate controls on access, for the
sharing of homeland security information, including
vulnerability assessments, security plans, best practices and
other laboratory biosecurity-related information, as the
Secretary determines appropriate, with State, local, and tribal
government authorities, including law enforcement authorities
and emergency response providers.
(b) Access to Information in Databases.--In carrying out this
section, the Secretary shall have access to and may use
information from the national databases established under
section 212(d)(2) of the Agricultural Bioterrorism Protection
Act of 2002 (7 U.S.C. 8401(d)(2)) and subsections (d)(2) and
(f)(3) of section 351A of the Public Health Service Act (42
U.S.C. 262a).
(c) Classified and Sensitive Information.--The Secretary
shall ensure that any information disseminated under this
section is handled consistent with--
(1) the authority of the Director of National
Intelligence to protect intelligence sources and
methods under the National Security Act of 1947 (50
U.S.C. 401 et seq.) and related procedures or similar
authorities of the Attorney General concerning
sensitive law enforcement information;
(2) section 552a of title 5, United States Code
(commonly referred to as the Privacy Act of 1974); and
(3) other relevant laws.
SEC. 2109. PERIODIC HOMELAND SECURITY REVIEW OF CRIMINAL STATUTES.
(a) In General.--The Secretary, in coordination with the
Attorney General and the heads of other Federal departments and
agencies, as appropriate, shall, for purposes of enhancing
homeland security--
(1) periodically review and recommend updates to
criminal laws to ensure that such laws are well suited
to the evolving risks of misuse of life sciences by
terrorists and others; and
(2) ensure that national biosecurity and biodefense
stakeholders at unique risk of exploitation have access
to guidance regarding actions that can reduce the risk
of misuse of life sciences by terrorists and others.
(b) Report.--Not later than one year after the date of the
enactment of this section, and biannually thereafter, the
Secretary, in coordination with the Attorney General, shall
submit to the appropriate congressional committees the
recommended updates to criminal laws, as described in
subsection (a)(1).
SEC. 2110. EXPORT ENFORCEMENT FOR COUNTER-PROLIFERATION.
(a) In General.--The Secretary, in coordination with the
Secretary of Commerce, the Secretary of Defense, the Attorney
General, the Secretary of State, the Director of National
Intelligence, and the heads of other appropriate Federal
agencies shall--
(1) conduct homeland security investigations and
enforce criminal violations of customs and export laws
of the United States related to military items,
controlled commodities, and sanctioned or embargoed
countries to prevent individuals, terrorist groups,
foreign adversaries, and hostile nations from--
(A) illegally obtaining sensitive United
States technology and munitions; and
(B) obtaining weapons of mass destruction
components, precursors, and delivery systems,
including--
(i) United States military technical
data, hardware, small arms and defense
services;
(ii) dual-use technical data/source
code and commodities; and
(iii) deemed exports; and
(2) conduct industry outreach with manufacturers and
exporters of strategic commodities that may be targeted
for procurement by terrorist organizations and the
countries that support them as well as countries
identified as weapons proliferators, in a manner that
acknowledges commerce and trade, by--
(A) educating companies and individuals on
the export laws of the United States;
(B) discussing export licensing issues and
requirements;
(C) identifying red flag indicators used in
illegal procurement;
(D) identifying the government agencies
responsible for the licensing of export-
controlled commodities and technology; and
(E) establishing and fostering relationships
whereby companies and individuals can report
suspicious contacts or attempts to violate the
export laws of the United States.
(b) National Export Enforcement Coordination.--
(1) Establishment; membership.--There is established
in the Department a unit responsible for national
export enforcement coordination that is managed by the
Secretary. The unit shall be composed of members who
are representatives from the Department, the Department
of Commerce, the Department of Defense, the Department
of Energy, the Department of Justice, the Department of
State, the Intelligence Community, and other Federal
agencies as appropriate.
(2) Responsibilities.--The unit shall carry out the
following responsibilities:
(A) Coordinating law enforcement counter-
proliferation investigations and intelligence
counter-proliferation activities.
(B) Addressing licensing inquiries, reviews,
requests, checks, and verifications.
(C) Conducting outreach and providing
training to the export trade community.
Subtitle B--Preparedness
SEC. 2121. COMMUNICATION OF THREAT INFORMATION AND ALERTS.
(a) Findings.--Congress makes the following findings:
(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 and their agents.
(b) Terrorism Threat Awareness.--
(1) Terrorism threat awareness.--The Secretary, in
coordination with the heads of appropriate Federal
agencies, shall 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, for purposes
of preparedness and collective response to terrorism
and for other purposes.
(2) Threat bulletins.--
(A) In general.--Consistent with the
requirements of paragraph (1), the Secretary
shall, on a timely basis, prepare unclassified
terrorism-related threat and risk assessments.
(B) Requirements.--Each assessment required
under subparagraph (A) shall--
(i) include guidance to the public
for preventing and responding to acts
of terrorism; and
(ii) be made available on the
Internet website of the Department and
other publicly accessible Internet
websites, communication systems, and
information networks.
(3) Guidance to state, local, and tribal
authorities.--The Secretary--
(A) acting through the Administrator of the
Federal Emergency Management Agency, 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 websites, communication systems, and
information networks in operation on the date of an
assessment under this subsection to satisfy the
requirements of paragraph (2)(B)(ii). 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. 2122. INDIVIDUAL AND COMMUNITY PREPAREDNESS FOR WEAPONS OF MASS
DESTRUCTION.
(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 weapons of mass destruction and
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) disseminating the guidance developed under
section 2151 to communities and individuals, as
appropriate;
(3) providing information and training materials in
support of individual and community preparedness
efforts;
(4) conducting individual and community preparedness
outreach efforts; and
(5) such other actions as the Secretary determines
appropriate.
(b) Coordination.--Where appropriate, the Secretary shall
coordinate with private sector and nongovernmental
organizations to promote individual and community preparedness
and collective response to weapons of mass destruction and
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)(3),
the Secretary shall give due regard to best practices based on
the experience of other countries and agencies and the
expertise of academic institutions and non-governmental
organizations.
Subtitle C--Detection
SEC. 2131. NATIONAL BIOSURVEILLANCE STRATEGY.
(a) Current State of Biosurveillance.--The Secretary shall
examine of the state of domestic and global biosurveillance.
(b) Strategy for Biosurveillance.--The Secretary shall submit
to the appropriate congressional committees a national strategy
for biosurveillance.
(c) Matters for Inclusion.--
(1) In general.--In developing the strategy required
under subsection (b), the Secretary shall take into
consideration--
(A) the state of biosurveillance domestically
and internationally;
(B) material threat assessments and
determinations developed by the Secretary in
accordance with the Project BioShield Act of
2004 (Public Law 108-276) and the amendments
made by that Act;
(C) reports on global trends produced by the
Office of the Director of National Intelligence
regarding the biological threat;
(D) information available in biosurveillance
systems and changes to information technology
to allow for the incorporation and integration
of this information;
(E) Intelligence Community needs as
articulated in relevant intelligence
strategies; and
(F) costs associated with establishing and
maintaining the necessary infrastructure to
integrate biosurveillance systems.
(2) Additional requirements.--This strategy required
under subsection (b) shall--
(A) include a plan for advancing situational
awareness;
(B) identify key elements of information to
be shared, critical sensitivities to be
protected, and a framework for enabling
information exchange;
(C) include a plan for fostering information
sharing between law enforcement, security,
intelligence, and national biosecurity and
biodefense stakeholders to identify potential
threats, reduce vulnerabilities and improve
collective response activities to and
investigations of suspected biological attacks;
and
(D) include strategic and implementation
plans for the National Biosurveillance
Integration Center under section 316.
SEC. 2132. DETECTION OF BIOLOGICAL ATTACKS.
(a) Program.--The Secretary shall carry out a program in the
Department to detect a biological attack or event. Through such
program, the Secretary shall--
(1) deploy detectors to areas, based on risk, to
indicate the presence of biological agents;
(2) provide information to participating laboratories
for their use in monitoring public health, and
biological material from these detectors to
participating laboratories for testing;
(3) provide information about the presence of
biological agents to public health and law enforcement
personnel at all levels of government; and
(4) provide advanced planning tools, concepts of
operations (including alarm resolution protocols), and
training exercises for collective response to and
recovery from biological attacks.
(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
filter testing protocols for participating laboratories
and coordination with appropriate State, local, and
tribal agencies;
(2) determine, on an annual basis, whether plans for
biological detector capabilities and coverage
sufficiently protect the United States population; and
(3) acting through the Under Secretary for Science
and Technology, and in consultation with the Director
for the Centers for Disease Control and Prevention,
implement an assay equivalency program for biological
threat assays that--
(A) may evaluate 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) may develop assay equivalency standards
based on the findings of the evaluation under
subparagraph (A);
(C) will be updated as necessary;
(D) shall require implementation of the
standards developed under subparagraph (B) for
all Department biological detection programs;
and
(E) shall make such standards available to
support all other Federal biological detection
programs.
(c) Contract Authority.--The Secretary is authorized to enter
into contracts with participating laboratories for--
(1) the provision of laboratory services to test
detector filters 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.
(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 Bioterrorism 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, the Federal Bureau of Investigation
and other law enforcement agencies with
responsibilities for investigating biological
incidents; and
(C) supports threat agent characterization
studies and 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. 2133. RAPID BIOLOGICAL THREAT DETECTION AND IDENTIFICATION.
(a) In General.--Notwithstanding section 302(4) the Secretary
shall require the Under Secretary for Science and Technology,
in consultation with the heads of other relevant operational
components of the Department, assess whether the development of
screening capabilities for biological agents, pandemic
influenza, and other infectious diseases should be undertaken
by the Science and Technology Directorate to support entry and
exit screening at ports of entry and for other 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
rapidly screen incoming travelers at ports of entry for
biological agents, pandemic influenza, and other infectious
diseases.
(c) Collaboration.--In developing methods under subsection
(b), the Secretary may collaborate with the heads of other
Federal agencies, as needed.
SEC. 2134. ESTABLISHMENT OF THE SYSTEM ASSESSMENT AND VALIDATION FOR
EMERGENCY RESPONDERS (SAVER) PROGRAM.
The Secretary, acting through the Under Secretary for Science
and Technology, 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 agents
used in weapons of mass destruction;
(2) is supported by a network of scientists who
perform the assessment and validation activities;
(3) provides results along with other relevant
equipment information to the emergency response
provider community in an operationally useful form;
(4) provides information on equipment that falls
within the categories listed in the Department's
authorized equipment list;
(5) provides information that enables decision-makers
and responders to better select, procure, use and
maintain emergency responder equipment; and
(6) shares such information nationally with the
emergency response provider community.
SEC. 2135. PAYMENT FOR BIOTERRORISM LABORATORY 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 to enter into
contracts with the State and local public health laboratories
that compose the Laboratory Response Network for Bioterrorism,
and any other qualified laboratories, for the provision of
laboratory testing services on a fee-for-service basis or on a
prepayment or other similar basis.
SEC. 2136. ESTABLISHMENT OF THE INTEGRATED CONSORTIUM OF LABORATORY
NETWORKS.
(a) Establishment.--There is established in the Department an
Integrated Consortium of Laboratory Networks that is managed by
the Secretary.
(b) Requirements.--The Integrated Consortium of Laboratory
Networks shall--
(1) be composed of networks of laboratories capable
of integrated and coordinated response to and
consequence management of attacks from weapons of mass
destruction, acts of terrorism, and other incidents
requiring laboratory response capabilities;
(2) be a coordinated and operational system of
laboratory networks that provide timely, high quality
results for early detection and effective consequence
management of attacks from weapons of mass destruction,
acts of terrorism, and other events requiring an
integrated laboratory response;
(3) serve as a system of laboratory networks that are
equipped to detect and respond quickly to attacks from
weapons of mass destruction and acts of terrorism;
(4) provide limited containment and analysis in
support of the Department, the Federal Bureau of
Investigation, and other law enforcement agencies with
responsibilities for investigating incidents involving
weapons of mass destruction or their agents; and
(5) support threat agent characterization studies and
assay evaluation, research and development.
Subtitle D--Attribution
SEC. 2141. BIOFORENSICS CAPABILITIES AND STRATEGY.
(a) National Bioforensics Analysis Center.--There is
established in the Department a National Bioforensics Analysis
Center which shall serve as the lead Federal facility to--
(1) provide definitive forensic examination of
biothreat agents and related evidence;
(2) provide necessary biocontainment;
(3) integrate bioforensics requirements for law
enforcement, national security, and homeland security;
(4) provide bioforensics analysis in support of the
executive agencies with primary responsibilities for
preventing, deterring, responding to, attributing, and
recovering from biological attacks;
(5) develop national bioforensics standards;
(6) maintain the national bioforensics repository
collection as a reference collection of biological
agents and toxins for bioforensics comparisons and
identifications; and
(7) support threat agent characterization studies and
bioforensics assay evaluation research and development.
(b) National Bioforensics Repository Collection.--
(1) In general.--The National Bioforensics Analysis
Center shall maintain a distributed national
bioforensics repository collection.
(2) Activities.--The national bioforensics repository
collection shall--
(A) receive, store, and distribute biological
threat agents and toxins;
(B) serve as a distributed reference
collection for comparative bioforensics
identifications and characterizations; and
(C) support threat agent characterization
studies and the development of bioforensics
assays, genomic analyses, organic and inorganic
chemical analyses, electron microscopy
analyses, and other relevant assays, analyses,
and tests.
(3) Participation.--
(A) In general.--The Secretary, the Attorney
General, the Secretary of Agriculture, the
Secretary of Defense, the Secretary of Energy,
the Secretary of Health and Human Services, the
Director of National Intelligence, and the head
of any other appropriate executive agency with
a biological agent or toxin collection that is
useful for the bioforensics analysis of
biological attacks, performance of biological
threat agent identification and
characterization studies, or evaluation and
development of bioforensics assays and methods
shall provide to the distributed national
bioforensics repository collection
authenticated replicate samples of, or
information on, all relevant biological strains
and toxins, as determined by the Secretary, in
consultation with the head of the executive
agency possessing the agent or toxin.
(B) Other biological agents and toxins.--The
Secretary shall require the contribution to the
national bioforensics repository collection of
authenticated replicate samples of, or
information on, all relevant biological strains
and toxins, as determined by the Secretary,
from public and private biological agent and
toxin collections that were collected or
created with support from a Federal grant or
contract and that support the functions
described in paragraph (2).
(4) Access.--The Secretary shall--
(A) provide any executive agency that submits
a biological agent or toxin, or information on
a biological agent or toxin, to the national
bioforensics repository collection with access
to the collection; and
(B) establish a mechanism to provide public
and private entities with access to agents or
toxins in, or information regarding, the
national bioforensics repository collection, as
determined appropriate by the Secretary, with
appropriate protection of classified or law
enforcement sensitive information and
intellectual property rights.
(5) Report.--
(A) In general.--Not later than one year
after the date of the enactment of this
section, and annually thereafter, the
Secretary, in consultation with the Attorney
General, the Secretary of Agriculture, the
Secretary of Defense, the Secretary of Energy,
the Secretary of Health and Human Services, the
Director of National Intelligence, and the head
of any other appropriate executive agency that
participates in or contributes agents, or
toxins, or information to the national
bioforensics repository collection, shall
submit to the appropriate committees of
Congress a report regarding the national
bioforensics repository collection.
(B) Contents.--The report submitted under
subparagraph (A) shall--
(i) discuss the status of the
establishment of the distributed
national bioforensics repository
collection;
(ii) identify domestic and
international biological agent and
toxin collections that would prove
useful in carrying out the functions of
the distributed national bioforensics
repository collection;
(iii) examine any access or
participation issues affecting the
establishment of the distributed
national bioforensics repository
collection or the ability to support
bioforensics analysis, threat agent
characterization studies, or
bioforensics assay evaluation,
research, and development, including--
(I) intellectual property
concerns;
(II) access to collected or
created biological agent or
toxin collections funded by a
Federal grant or contract;
(III) costs incurred by
domestic and international
biological agent and toxin
collections to access or
contribute biological agents or
toxins to the national
bioforensics repository
collection; and
(IV) access to the national
bioforensics repository
collection by public and
private researchers to support
threat agent characterization
studies, bioforensics assay
evaluation, research, and
development, and biosecurity
research and development; and
(iv) other issues determined
appropriate.
(c) National Bioforensics Strategy.--
(1) In general.--The Secretary, in coordination with
the Attorney General, the Secretary of Agriculture, the
Secretary of Defense, the Secretary of Health and Human
Services, the Director of National Intelligence, and
the head of any other appropriate executive agency, as
determined by the Secretary, shall develop, coordinate,
and maintain a national bioforensics strategy.
(2) Contents.--The national bioforensics strategy
shall--
(A) provide for a coordinated approach across
all executive agencies with responsibilities
for--
(i) conducting bioforensics
examination of biological threat agents
and related evidence; and
(ii) generating bioforensics
requirements for law enforcement,
national security, and homeland
security;
(B) describe the roles and responsibilities
of all relevant executive agencies, including--
(i) research to characterize threat
agents;
(ii) assay evaluation, research, and
development; and
(iii) funding;
(C) establish mechanisms, in coordination
with State, local, and tribal authorities, for
coordinating with public health, homeland
security, and law enforcement agencies for the
collection or receipt, transfer, or submission
of bioforensics evidence for analysis and its
use; and
(D) include--
(i) guidance for collecting,
processing, and analyzing samples;
(ii) requirements for reporting
bioforensics information to appropriate
agencies; and
(iii) requirements for the
distributed national bioforensics
repository collection.
(3) Report.--Not later than one year after the date
of the enactment of this section, and biennially
thereafter, the Secretary, in consultation with the
Attorney General, the Secretary of Agriculture, the
Secretary of Defense, the Secretary of Health and Human
Services, the Director of National Intelligence, and
the heads of other appropriate agencies, as determined
by the Secretary, shall submit to the appropriate
committees of Congress the national bioforensics
strategy.
(d) Concept of Operations.--The Secretary, in coordination
with the Attorney General and the heads of any other
appropriate Federal agencies shall ensure the availability of a
detailed concept of operations for information sharing and all-
source analysis to support timely attribution of biological
attacks.
(e) Detailee Program.--Subject to the availability of
appropriations, the Secretary may implement a detailee program
to detail from governmental entities national biosecurity and
biodefense stakeholders with appropriate clearances, on a
reimbursable basis, to the National Bioforensics Analysis
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 National Bioforensics
Analysis Center with national biosecurity and
biodefense stakeholders.
(f) Research and Development.--The Secretary, in coordination
with the Attorney General and the heads of any other
appropriate Federal agencies, shall establish a national-level
research and development strategy and implementation plan to
advance the field of bioforensics.
(g) Definition of Bioforensics.--In this section, the term
``bioforensics'' means the scientific discipline dedicated to
analyzing evidence from an attack with a biological weapon of
mass destruction, an act of bioterrorism, a biological agent-
or toxin-based criminal act, or the inadvertent release of a
biological agent or toxin for attribution purposes.
SEC. 2142. FEDERAL LAW ENFORCEMENT TRAINING TO INVESTIGATE BIOLOGICAL
THREATS.
The Secretary, in coordination with the Attorney General, the
Secretary of Agriculture, the Secretary of Health and Human
Services, and the heads of other appropriate Federal
departments and agencies, shall make available to law
enforcement, public health, and security personnel at the
Federal Law Enforcement Training Center training on recognizing
and responding to situations involving potential biological
threats, including performing joint criminal and
epidemiological investigations, and shall--
(1) ensure that tailored tactics, techniques, and
procedures are made available to law enforcement and
security personnel, including access to the tools
needed to respond to biological threats;
(2) promote the use of simulation among Federal
partners to exercise capabilities, refine operational
concepts, and strengthen relationships across the
Government; and
(3) make training available that will ensure that law
enforcement, public health, and agricultural
investigations of biological threats are coordinated.
Subtitle E--Response
SEC. 2151. FIRST RESPONDER GUIDANCE CONCERNING WEAPONS OF MASS
DESTRUCTION ATTACKS.
(a) Establishment of Voluntary Guidance.--Not later than one
year after the date of the enactment of this section, the
Secretary shall--
(1) develop for police, fire, emergency medical
services, emergency management, and public health
personnel, voluntary guidance for responding to a
release of chemical, biological, radiological, or
nuclear material;
(2) in developing the guidance under paragraph (1),
review the experiences of other countries and the
expertise of academic institutions and non-governmental
organizations; and
(3) make such guidance available to State, local, and
tribal authorities, nongovernmental organizations, the
private sector, and the public.
(b) Contents.--The guidance developed under subsection (a)(1)
shall include--
(1) protective action guidance for ensuring the
security, health, and safety of emergency response
providers;
(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 deal with 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) inventory existing relevant hazardous material
response guidance;
(2) 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);
(3) determine which entities should be consulted in
developing or revising the guidance;
(4) prioritize, on a regular basis, guidance that
should be developed or revised; and
(5) develop and disseminate the guidance in
accordance with the prioritization under paragraph (4).
(e) Consultations.--The Secretary shall develop and revise
the guidance developed under subsection (a)(1), and the
procedures required under subsection (d), in consultation
with--
(1) the heads of other Federal departments and
agencies, as appropriate;
(2) the National Advisory Council established under
section 508;
(3) the National Domestic Preparedness Consortium;
(4) State, local, and tribal authorities; and
(5) nongovernmental organizations and private
industry.
(f) Reporting Requirements.--Not later than 18 months after
the date of the enactment of this section and annually
thereafter, the Secretary shall submit to the appropriate
congressional committees--
(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) 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. 2152. INTEGRATED PLUME MODELING FOR COLLECTIVE RESPONSE.
(a) Development.--
(1) In general.--The Secretary shall acquire, use,
and disseminate integrated plume models to enable rapid
response activities following a chemical, biological,
nuclear, or radiological attack or event.
(2) Scope.--The Secretary shall--
(A) ensure the rapid development and
distribution of integrated plume models to
appropriate officials of the Federal Government
and State, local, and tribal authorities to
enable immediate response to a chemical,
biological, or radiological 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 the development and
dissemination of integrated plume models are
assessed during exercises administered by the
Department; 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
Department of Homeland Security Lessons Learned
Information Sharing system.
(b) Report.--Not later than one year after the date of
enactment of this section, and annually thereafter, the
Secretary shall submit to the appropriate congressional
committees a report regarding--
(1) the acquisition, use, and dissemination of
integrated plume models under this section;
(2) lessons learned from assessing the development
and dissemination of integrated plume models during
exercises administered by the Department; and
(3) recommendations for improving integrated plume
models, as appropriate.
(c) 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.
Subtitle F--Recovery
SEC. 2161. RECOVERY AND RESTORATION FROM A BIOLOGICAL ATTACK OR
INCIDENT GUIDANCE.
(a) Establishment of Guidance.--Not later than one year after
the date of the enactment of this section, the Secretary, in
coordination with the Administrator of the Environmental
Protection Agency and in consultation with the Director of the
Occupational Safety and Health Agency, and the Director of the
National Institute for Occupational Safety and Health, 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 affected by a
biological attack or event.
(b) Contents.--The guidance developed under subsection (a)
shall include--
(1) acceptable levels of growth of the organism in
post-remediation area samples from affected sites;
(2) standards for effective clean-up of affected
sites;
(3) standards for safe post-event occupancy of
affected sites;
(4) requirements to ensure that the decontamination
procedures for responding organizations do not
conflict;
(5) requirements that each responding organization
uses a uniform system for tracking costs and
performance of clean-up contractors;
(6) levels of personal protection equipment;
(7) maintenance of negative air pressure in
buildings;
(8) standards for proper selection and use of
personal protective equipment;
(9) air sampling procedures; and
(10) how to develop occupational health and safety
plans that are appropriate for the specific risk to
responder health.
(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) inventory existing relevant guidance;
(2) enable the public to submit recommendations of
areas in which guidance is needed;
(3) determine which entities should be consulted in
developing or revising the guidance;
(4) prioritize, on a regular basis, guidance that
should be developed or revised; and
(5) develop and disseminate the guidance in
accordance with the prioritization under paragraph (4).
(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, as appropriate;
(2) State, local, and tribal authorities; and
(3) nongovernmental organizations and private
industry.
(f) Report.--Not later than one 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) were 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.
----------
POST-KATRINA EMERGENCY MANAGEMENT REFORM ACT OF 2006
* * * * * * *
TITLE VI--NATIONAL EMERGENCY MANAGEMENT
* * * * * * *
Subtitle C--Comprehensive Preparedness System
CHAPTER 1--NATIONAL PREPAREDNESS SYSTEM
* * * * * * *
SEC. 653. FEDERAL PREPAREDNESS.
(a) Agency Responsibility.--In support of the national
preparedness system, the President shall ensure that each
Federal agency with responsibilities under the National
Response Plan--
(1) * * *
* * * * * * *
(4) develops deliberate operational plans and the
corresponding capabilities, including crisis planning,
to respond effectively to natural disasters, acts of
terrorism, and other man-made disasters, and a
communications plan described in subsection (f) in
support of the National Response Plan to ensure a
coordinated Federal response; and
* * * * * * *
(f) Communications Plan.--
(1) In general.--A communications plan developed
under subsection (a)(4) shall be designed to provide
information to the public related to preventing,
preparing for, and responding to attacks from weapons
of mass destruction and acts of terrorism;
(2) Consultation.--As appropriate, the Administrator
shall consult with State, local, and tribal authorities
and coordinate with other Federal departments and
agencies in developing communications plans under
paragraph (1).
(3) Pre-scripted messages and message templates.--
(A) In general.--The Administrator shall
develop and disseminate pre-scripted messages
and message templates to be provided to 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 an attack from a weapon of mass
destruction or terrorist incident, 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; and
(iii) be designed to provide
accurate, essential, and appropriate
information and instructions to
emergency response providers and
medical personnel responding to an
incident.
(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; and
(ii) to individuals with disabilities
or other special needs and individuals
with limited English proficiency.
(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 such pre-
scripted messages or message templates into
exercises conducted under the National Exercise
Program described in section 648 of the Post-
Katrina Emergency Management Reform Act of 2006
(6 U.S.C. 748).
* * * * * * *
----------
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) determine which of such agents
present a material threat against the
United States population sufficient to
affect national security[.]; and
(iii) review and reassess
determinations under clause (ii) 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.--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.
(c) Coordination.--Where appropriate, the Secretary shall
coordinate with State, local, and tribal authorities, private
sector, and nongovernmental organizations on the National
Medical Countermeasures Dispensing Strategy.
(d) Report.--Not later than one year after the date of the
enactment of this section, the Secretary, in coordination with
the Secretary of Homeland Security, shall submit the National
Medical Countermeasures Dispensing Strategy to the appropriate
congressional committees.
* * * * * * *
SEC. 319N. BIOTECHNOLOGY RESEARCH, DEVELOPMENT, AND PROCUREMENT.
(a) In General.--The Secretary shall develop a comprehensive
research, development, and acquisition process to counter the
biological threat that employs the inherent functions,
capabilities, authorities, and responsibilities of NIH, BARDA,
and Project BioShield. The process shall--
(1) assign NIH responsibility for research and
development of technologies that range in development
from basic principles observed and reported up to model
or prototype demonstration in a relevant environment;
(2) assign BARDA responsibility for research and
development of technologies that range in development
from model or prototype demonstration in a relevant
environment up to a system qualified for application
through successful test and demonstration;
(3) assign Project BioShield responsibility for
procurement of technologies that--
(A) are qualified for application through
successful test and demonstration; and
(B) meet the minimum statutory requirements
for emergency use authorization in section 564
of the Federal Food, Drug, and Cosmetic Act;
and
(4) include a formal agreement among NIH, BARDA, and
Project BioShield that--
(A) identifies the need for any specific
biological countermeasure, derived from
information developed under section 319F-2;
(B) identifies the current technology
readiness level of the countermeasure; and
(C) requires the development of the
biological countermeasure from the current
technology readiness level through the
procurement of the countermeasure in accordance
with paragraph (3).
(b) Responsibility of NIH.--For countermeasures identified
under subsection (a)(4)(A) that have a level of development
from basic principles observed and reported up to model or
prototype demonstration in a relevant environment, the Director
of NIH shall conduct research and development until the
Director certifies to the Secretary of Health and Human
Services that--
(1) the countermeasure has completed model or
prototype demonstration in a relevant environment; or
(2) the Director does not believe that completion of
model or prototype demonstration in a relevant
environment is reasonably achievable.
(c) Responsibility of BARDA.--For countermeasures identified
under subsection (a)(4)(A) that have a level of development of
model or prototype demonstration in a relevant environment,
including but not limited to those countermeasures certified to
have that level of development by the Director of NIH, the
Director of BARDA shall conduct research and development until
the Director of BARDA certifies to the Secretary of Health and
Human Services that--
(1) the countermeasure has qualified for application
through successful test and demonstration; or
(2) the Director does not believe that qualification
for application through successful test and
demonstration is reasonably achievable.
(d) Responsibility of Project Bioshield.--For countermeasures
identified under subsection (a)(4)(A) that are qualified for
application through successful test and demonstration,
including but not limited to those countermeasures certified to
have qualified for application through successful test and
demonstration by the Director of BARDA, the Assistant Secretary
of Health and Human Services for Preparedness and Response
shall use the Project BioShield special reserve fund to may
procure the countermeasure if the countermeasure meets the
requirements for emergency use authorization described in
subsection (a)(3)(B).
(e) No Requirement for Food and Drug Administration General
Use Approval.--The Secretary shall ensure that the Directors of
NIH and BARDA and the Assistant Secretary of Health and Human
Services for Preparedness and Response do not discontinue any
research, development, or procurement of a countermeasure
identified under subsection (a)(4)(A) because the Food and Drug
Administration has not, or decides against, approving or
licensing the countermeasure for general use under chapter V of
the Federal Food, Drug, and Cosmetic Act or section 351 of this
Act, as applicable.
(f) Innovation.--The Secretary shall require the Directors of
NIH and BARDA and the Assistant Secretary of Health and Human
Services for Preparedness and Response to aggressively pursue
innovative research, development, and procurement of each
countermeasure identified under subsection (a)(4)(A).
(g) Definitions.--In this section:
(1) The term ``BARDA'' means the he Biomedical
Advanced Research and Development Authority established
under section 319L(c).
(2) The term ``NIH'' means the National Institutes of
Health.
(3) The term ``Project Bioshield'' means the Federal
medical countermeasure procurement program established
by Public Law 108-276.
* * * * * * *
Part F--Licensing--Biological Products and Clinical Laboratories
* * * * * * *
Subpart 1--Biological Products
* * * * * * *
SEC. 351A. ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS AND TOXINS.
(a) Regulatory Control of Certain Biological Agents and
Toxins.--
(1) * * *
(2) Tier i material threat agents.--
(A) Designation of tier i: material threat
agents.--Not later than 1 year after the date
of the enactment of this paragraph, the
Secretary, in coordination with the Secretary
of Homeland Security and other Federal
officials as appropriate, shall by regulation
designate as ``Tier I Material Threat Agents''
those agents and toxins--
(i) that--
(I) are determined by the
Secretary of Homeland Security
under section 319F-2(c)(2) to
present a material threat
against the United States
population sufficient to affect
national security; and
(II) are determined to
warrant designation after
applying the criteria in
subparagraph (B); or
(ii) that clearly present a material
threat to the Nation as otherwise
determined by the Secretary or the
Secretary of Homeland Security.
(B) Criteria.--In determining whether to
designate an agent or toxin as a Tier I
Material Threat Agent under subparagraph
(A)(i), the Secretary, in coordination with the
Secretary of Homeland Security, shall
consider--
(i) whether the agent or toxin can be
used effectively in a biological
attack;
(ii) information available from any
biological or bioterrorism risk
assessments conducted by the Department
of Homeland Security and relevant
assessments by other agencies; and
(iii) such other criteria and
information as the Secretary, in
coordination with the Secretary of
Homeland Security, determines
appropriate and relevant.
(C) Inclusion of agents and toxins not
previously listed.--All agents or toxins
designated by the Secretary as Tier I Material
Threat Agents shall be included on the list
maintained by the Secretary pursuant to
paragraph (1).
(D) Evaluation of tier i material threat
agents.--The Secretary, in coordination with
the Secretary of Homeland Security, shall--
(i) on an ongoing basis, consider the
inclusion of additional agents or
toxins on the list of Tier I Material
Threat Agents, as appropriate; and
(ii) at least biennially, review the
list of Tier I Material Threat agents
to determine whether any agents or
toxins should be removed from the list.
[(2)] (3) Biennial review.--The Secretary shall
review and republish the [list under paragraph (1)]
lists under paragraphs (1) and (2) biennially, or more
often as needed, and shall by regulation [revise the
list] revise the lists as necessary in accordance with
such paragraph.
* * * * * * *
(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 coordinate 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.
* * * * * * *
----------
AGRICULTURAL BIOTERRORISM PROTECTION ACT OF 2002
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
* * * * * * *
Subtitle B--Department of Agriculture
* * * * * * *
SEC. 212. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.
(a) Regulatory Control of Certain Biological Agents and
Toxins.--
(1) * * *
(2) Tier i material threat agents.--
(A) Designation of tier i: material threat
agents.--Not later than one year after the date
of the enactment of this paragraph, the
Secretary, in coordination with the Secretary
of Homeland Security, the Secretary of Health
and Human Services, and other Federal officials
as appropriate, shall by regulation designate
as ``Tier I Material Threat Agents'' those
agents and toxins--
(i) that--
(I) are determined by the
Secretary of Homeland Security
under section 319F-2(c)(2) of
the Public Health Service Act
to present a material threat
against the United States
population sufficient to affect
national security; and
(II) are determined to
warrant designation after
applying the criteria in
subparagraph (B); or
(ii) that clearly present a material
threat to the Nation as otherwise
determined by the Secretary or the
Secretary of Homeland Security.
(B) Criteria.--In determining whether to
designate an agent or toxin as a Tier I
Material Threat Agent under subparagraph
(A)(i), the Secretary, in coordination with the
Secretary of Homeland Security, shall
consider--
(i) whether the agent or toxin can be
used effectively in a biological
attack;
(ii) information available from any
biological or bioterrorism risk
assessments conducted by the Department
of Homeland Security and relevant
assessments by other agencies; and
(iii) such other criteria and
information that the Secretary, in
coordination with the Secretary of
Homeland Security, determines
appropriate and relevant.
(C) Inclusion of agents and toxins not
previously listed.--All agents or toxins
designated by the Secretary as Tier 1 Material
Threat Agents shall be included on the list
maintained by the Secretary pursuant to
paragraph (1).
(D) Evaluation of tier i material threat
agents.--The Secretary, in coordination with
the Secretary of Homeland Security, shall--
(i) on an ongoing basis, consider the
inclusion of additional agents or
toxins on the list of Tier I Material
Threat Agents, as appropriate; and
(ii) at least biennially, review the
list of Tier I Material Threat agents
to determine whether any agents or
toxins should be removed from the list.
[(2)] (3) Biennial review.--The Secretary shall
review and republish the [list under paragraph (1)]
lists under paragraphs (1) and (2) biennially, or more
often as needed, and shall by regulation [revise the
list] revise the lists as necessary in accordance with
such paragraph.
* * * * * * *
ADDITIONAL VIEWS OF CONGRESSMAN PETE OLSON
I was unavoidably absent for the consideration of H.R.
5498, the WMD Prevention and Preparedness Act of 2010. Had I
been present I would have voted ``aye.'' Nonetheless, there are
provisions of the legislation, specifically the provisions
affecting our nation's National Labs that, I believe, warrant
comment.
First, and most notably, similar legislation introduced by
Senator Lieberman and Senator Collins, S. 1649, mistakenly
requires the Department of Homeland Security to inspect select
agent labs currently overseen by HHS and USDA labs. Thankfully,
H.R. 5498 makes a crucial and wise revision. H.R. 5498 permits
HHS and USDA to continue to inspect labs housing select agents
but requires them to provide DHS the data concerning
inspections of laboratories that handle Tier 1 Material Threat
Agents. This will ensure uniformity of enforcement of the
enhanced biosecurity measures.
The Houston-Galveston region--a region I represent in
Congress--is the proud home of the Galveston National
Laboratory (GNL). The GNL is an academic research center
located on the campus of the University of Texas Medical Branch
(UTMB) in Galveston, Texas. The GNL's renowned scientists work
collaboratively, both locally and internationally, to tackle
some of the world's most pressing health concerns. With
strengths in infectious disease research and specialized
programs in aerobiology, assay development, experimental
pathology, imaging, and immunology, the GNL advances local
discoveries on the diagnostic tests, treatments and vaccines
for the infectious diseases impacting global health like
tuberculosis, severe acute respiratory syndrome (SARS) virus,
West Nile virus, Ebola, Marburg, Plague, encephalitis,
hepatitis, and influenza, among others. The science and study
of these agents remains paramount to public health, and, as a
country, we must find a way to equip scientists and researchers
in studying these agents without broadening accessibility to
potential bioterrorism or misuse of these agents. Global health
is principal to national security. The majority of these agents
themselves are not weapons of mass destruction. Rather, they
occur routinely in nature. Hence, striking a balance between
our ability to maintain groundbreaking research and rapidly
responding when outbreaks occur, often in concert with our
international partners, is vital.
It is my belief that too many lists of regulated biological
agents and toxins, with varying lead agencies of jurisdiction,
will result in confusion along with ineffective implementation.
It is of the utmost importance that the current relevant
regulations be harmonized with the prospective Tier I
regulations outlined in H.R. 5498. This, along with a well
defined enforcement authority, is the key to the overall goal
of safety and security.
Additionally, H.R. 5498 removes the creation of a
``registry agents'' category. I applaud this measure as I
believe it provides the proper legislative focus and decreases
the potential administrative burden placed on the scientific
community. I also applaud this legislation's call for national
and international training programs to enhance biosafety
practices and biosecurity measures at laboratories conducting
research with select agents.
Finally, H.R. 5498 creates a High Containment Biological
Laboratory Security Grant program. This is a welcome addition
to any legislation regarding the security of U.S. high
containment laboratories. The GNL alone spends approximately $2
million per year on security personnel. The vast majority of
academic centers and nonprofit organizations that engage in
research with infectious diseases will only be able to shoulder
the additional security costs mandated if it is supplemented
with a sustained investment by the federal government.
Because of these provisions, and because this legislation,
as a whole, is vitally important to our nation's security, I
support passage of H.R. 5498.
