[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5498 Introduced in House (IH)]
111th CONGRESS
2d Session
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 10, 2010
Mr. Pascrell (for himself, Mr. King of New York, Mr. Thompson of
Mississippi, Ms. Clarke, and Mr. Daniel E. Lungren of California)
introduced the following bill; which was referred to the Committee on
Homeland Security, and in addition to the Committees on Energy and
Commerce, Agriculture, Transportation and Infrastructure, Foreign
Affairs, and Select Intelligence (Permanent Select), for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
A BILL
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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. Deadline for completion of methods to rapidly screen
travelers at ports of entry.
Sec. 207. Report on establishment of the system assessment and
validation for emergency responders (SAVER)
program.
Sec. 208. National Academy of Sciences study of forensic science in
homeland security.
Sec. 209. Harmonization of regulations.
Sec. 210. Communications planning for weapons of mass destruction
information dissemination.
Sec. 211. Report on 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 I 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) of 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 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 governments; 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 officials, 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).
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 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).
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 partners 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.
``(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 and intelligence and information sharing
process national biosecurity and biodefense stakeholders within
Federal, State, local, tribal, and private sector communities;
``(2) develop an information sharing framework for homeland
security intelligence and information sharing with 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 Secretary of State.--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) consider terrorists as intelligent adversaries and
take into account information regarding the decision-making
processes of terrorists;
``(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 relative 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 relevant 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. ENHANCED BIOSECURITY MEASURES.
``(a) Regulations.--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 205 of the Pandemic and All-Hazards
Preparedness Act (Public Law 109-417; 120 Stat. 2851));
``(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) representatives from the scientific community 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 Health and Human Services
and the Secretary of Agriculture shall periodically
provide the Secretary with all data concerning
inspections of laboratories that handle Tier I 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 Health and Human Services or the
Secretary of Agriculture about approaches to enhance
security at specific laboratories.
``(B) Simultaneous inspections.--Any inspections of
the same laboratory conducted by 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, and the Secretary of Agriculture pursuant to
section 212(a)(1) of the Agricultural Bioterrorism
Protection Act of 2002 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. 2105. 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. 2106. 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 governments that possess, use, or transfer
Tier I Material Threat Agents, to enhance security at laboratories of
such organizations and governments.
``(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. 2107. 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 officials, including law enforcement
officials 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 subsections (d)(2) and
(f)(3) of section 351A of the Public Health Service Act (42 U.S.C.
262a) and section 212(d)(2) of the Agricultural Bioterrorism Protection
Act of 2002 (7 U.S.C. 8401(d)(2)).
``(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. 2108. 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 biodefense and biosecurity
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. 2109. 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 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, 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 Network.--
``(1) Establishment; membership.--There is established in
the Department a National Export Enforcement Coordination
Network that is managed by the Secretary. The Network 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 Network 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 general
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 governments.--
The Secretary--
``(A) acting through the Administrator of the
Federal Emergency Management Agency, shall provide to
State, local, and tribal governments 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).
``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 governments in improving and promoting individual and
community preparedness and collective response to weapons of mass
destruction and terrorist attacks involving biological, chemical,
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) compiling and disseminating information on best
practices for individual and community preparedness;
``(4) providing information and training materials in
support of individual and community preparedness efforts;
``(5) conducting individual and community preparedness
outreach efforts; and
``(6) such other actions as the Secretary determines
appropriate.
``(b) Coordination.--Where appropriate, the Secretary shall
coordinate with private sector and nongovernmental organizations to
promote individual and community preparedness.
``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, and Intelligence
Community requirements;
``(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 public health, law enforcement,
security, intelligence, and the scientific communities
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
biomonitoring programs; and
``(E) shall make such standards available to
support all other Federal biomonitoring 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 primary 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
and 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 weapons of mass destruction 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 weapons of mass destruction
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, and to support
effective all-hazard laboratory response;
``(4) provide limited containment and analysis in support
of the Department, the Federal Bureau of Investigation, and
other law enforcement agencies with primary 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 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 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 authenticated replicate samples
of 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, which shall not include any variola virus but
shall include any virus modified to include any part of
the variola virus, to the national bioforensics
repository collection.
``(B) Other biological agents and toxins.--The
Secretary shall require the contribution of public and
private biological agent and toxin collections to the
national bioforensics repository collection that were
collected or created with support from a Federal grant
or contract and that support the functions described in
paragraph (2).
``(4) Access.--The Secretary shall--
``(A) provide any executive agency that submits 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 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 to the national bioforensics repository
collection, shall submit to the appropriate committees
of Congress a report regarding the national
bioforensics repository collection.
``(B) Contents.--The report submitted under
subparagraph (A) shall--
``(i) discuss the status of the
establishment of the national bioforensics
repository collection;
``(ii) identify domestic and international
biological agent and toxin collections that
would prove useful in carrying out the
functions of the national bioforensics
repository collection;
``(iii) examine any access or participation
issues affecting the establishment of the
national bioforensics repository collection or
the ability to support 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 associated with
accessing, procuring, and securely
transporting biological materials from
domestic and international biological
agent and toxin collections to the
national bioforensics repository
collection;
``(IV) 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
``(V) 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 governments, for coordinating
with public health, environmental quality, 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; and
``(ii) requirements for reporting
bioforensics information to appropriate
agencies.
``(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) 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.
``(f) 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. 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--
``(1) make training available to law enforcement, public
health, and security personnel on recognizing and responding to
situations involving potential biological threats, including
performing joint criminal and epidemiological investigations;
``(2) 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;
``(3) promote the use of simulation among Federal partners
to exercise capabilities, refine operational concepts, and
strengthen relationships across the Government; and
``(4) 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; and
``(2) make such guidance available to State, local, and
tribal governments, 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 governments, 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 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) State, local, and tribal governments; and
``(4) 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 timely integrated plume models to enable rapid
response activities following a chemical, biological, nuclear,
or radiological release.
``(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
governments to enable immediate response to a chemical,
biological, or radiological incident;
``(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.
``(3) Consultation with other departments and agencies.--In
identifying and developing the integrated plume models
described in this section, the Secretary shall consult, as
appropriate, with--
``(A) the Secretary of Defense, the Secretary of
Energy, the Secretary of Health and Human Services, and
the heads of other appropriate Federal agencies; and
``(B) State, local, and tribal governments and
nongovernmental organizations.
``(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 development 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) plans for improving the development and dissemination
of 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 nuclear, radioactive,
or chemical fallout and biological pathogens resulting from a
release of chemical, biological, radiological, or nuclear
materials.
``(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 that have been affected by the
release of a biological agent.
``(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) proper selection and use of personal protective
equipment;
``(9) proper use of personal protective equipment;
``(10) air sampling procedures; and
``(11) how to develop 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 governments,
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 governments; 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.
``SEC. 2162. 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 officials to recover from a chemical,
biological, radiological or nuclear attack or incident.
``(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
governments; 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.''.
(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:
Sec. 201. Weapons of mass destruction prevention and preparedness.
``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. Enhanced biosecurity measures.
``Sec. 2105. Tier I Material Threat Agent locations.
``Sec. 2106. High containment biological laboratory security
grants.
``Sec. 2107. Laboratory biosecurity information sharing.
``Sec. 2108. Periodic homeland security review of criminal
statutes.
``Sec. 2109. 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. 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. 2162. Environmental recovery from chemical, biological,
radiological, and nuclear attacks.
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.--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 by not later than one year after the date of enactment of
this Act 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 (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
governments 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 governments.''.
SEC. 206. DEADLINE FOR COMPLETION OF METHODS TO RAPIDLY SCREEN
TRAVELERS AT PORTS OF ENTRY.
Not later than 90 days after the date of the enactment of this Act,
the Secretary of Homeland Security shall complete the development of
the methods to rapidly screen travelers at ports of entry, as required
under subsection (b) of section 2133 of the Homeland Security Act of
2002, as added by section 201.
SEC. 207. 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. 208. 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. 209. 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 and 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 and are not in
conflict with the regulations promulgated by the Secretary under such
section 2104.
SEC. 210. 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 ``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 governments and
coordinate with other Federal departments and agencies in
developing communications plans under paragraph (1).
``(3) Prescripted 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
officials so that those officials can quickly and
rapidly disseminate critical information to the public
in anticipation 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 governments 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 governments so that those governments may
incorporate them, as appropriate, into their emergency
plans. The Administrator shall also make available
relevant technical assistance to those governments to
support communications planning.
``(E) Exercises.--To ensure that the 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. 211. REPORT ON RECOVERY FROM CHEMICAL, BIOLOGICAL, RADIOLOGICAL,
AND NUCLEAR ATTACKS.
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.
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
an 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 government officials, 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 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 I 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 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''.
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 for counter-bioterrorism
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 counter-bioterrorism 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 counter-bioterrorism 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 counter-bioterrorism 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 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) Entrepreneurial Risk.--The Secretary shall require the
Directors of NIH and BARDA and the Assistant Secretary of Health and
Human Services for Preparedness and Response to demonstrate a
reasonably aggressive level of entrepreneurial risk in research,
development, and procurement of each countermeasure identified under
subsection (a)(4)(A).
``(g) Definitions.--In this section:
``(1) The term `BARDA' means the 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--
(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.
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