19–006 

112TH CONGRESS REPT. 112–665 " ! HOUSE OF REPRESENTATIVES 2d Session Part 1 

WMD PREVENTION AND PREPAREDNESS ACT OF 2012 

SEPTEMBER 12, 2012.—Ordered to be printed 

Mr. KING of New York, from the Committee on Homeland Security, 

submitted the following 

R E P O R T 

together with 

ADDITIONAL VIEWS 

[To accompany H.R. 2356] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Homeland Security, to whom was referred the 

bill (H.R. 2356) to enhance homeland security by improving efforts 

to prevent, protect against, respond to, and recover from an attack 

with a weapon of mass destruction, and for other purposes, having 

considered the same, report favorably thereon with an amendment 

and recommend that the bill as amended do pass. 

CONTENTS 

Page 

Purpose and Summary ............................................................................................ 27 

Background and Need for Legislation .................................................................... 27 

Hearings ................................................................................................................... 28 

Committee Consideration ........................................................................................ 32 

Committee Votes ...................................................................................................... 33 

Committee Oversight Findings ............................................................................... 34 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 34 

Congressional Budget Office Estimate ................................................................... 34 

Statement of General Performance Goals and Objectives .................................... 36 

Congressional Earmarks, Limited Tax Benefits, and Limited Tariff Benefits ... 38 

Federal Mandates Statement ................................................................................. 38 

Preemption Clarification ......................................................................................... 38 

Advisory Committee Statement .............................................................................. 38 

Applicability to Legislative Branch ........................................................................ 38 

Section-by-Section Analysis of the Legislation ...................................................... 38 

Changes in Existing Law Made by the Bill, as Reported ..................................... 61 

Additional Views ...................................................................................................... 87 


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The amendment is as follows: 

Strike all after the enacting clause and insert the following: 

SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

(a) SHORT TITLE.—This Act may be cited as the ‘‘WMD Prevention and Preparedness Act of 2012’’. 

(b) TABLE OF CONTENTS.—The table of contents for this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Definitions. 

TITLE I—A NATIONAL BIODEFENSE ENTERPRISE 

Sec. 101. Special Assistant for Biodefense. 

Sec. 102. National Biodefense Plan. 

Sec. 103. National Biosurveillance Strategy. 

Sec. 104. Comprehensive cross-cutting biodefense budget analysis. 

TITLE II—INTELLIGENCE MATTERS 

Sec. 201. National Intelligence Strategy for Countering the Threat from Weapons of Mass Destruction. 

Sec. 202. National Intelligence Strategy for Countering Biological Threats. 

Sec. 203. State, local, and tribal defined. 

TITLE III—HOMELAND SECURITY MATTERS 

Sec. 301. Weapons of mass destruction prevention and preparedness. 

‘‘TITLE XXI—WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS 

‘‘Subtitle A—Prevention 

‘‘Sec. 2101. Weapons of mass destruction intelligence and information sharing. 

‘‘Sec. 2102. Risk assessments. 

‘‘Sec. 2103. National Export Enforcement Coordination. 

‘‘Sec. 2104. Communication of threat information. 

‘‘Sec. 2105. Individual and community preparedness for chemical, biological, radiological, and nuclear attacks. 

‘‘Subtitle B—Protection 

‘‘Sec. 2121. Detection of biological attacks. 

‘‘Sec. 2122. Rapid biological threat detection and identification at ports of entry. 

‘‘Sec. 2123. Evaluating detection technology. 

‘‘Sec. 2124. Domestic implementation of the Global Nuclear Detection Architecture. 

‘‘Subtitle C—Response 

‘‘Sec. 2131. First responder guidance concerning chemical, biological, radiological, and nuclear attacks. 

‘‘Sec. 2132. Integrated plume modeling for collective response. 

‘‘Sec. 2133. Establishment of the system assessment and validation for emergency responders (SAVER) program. 

‘‘Sec. 2134. Payment for laboratory response services. 

‘‘Sec. 2135. Bioforensics capabilities. 

‘‘Sec. 2136. Metropolitan Medical Response System Program. 

‘‘Subtitle D—Recovery 

‘‘Sec. 2141. Identifying and addressing gaps in recovery capabilities. 

‘‘Sec. 2142. Recovery from a chemical, biological, radiological, and nuclear attack or incident. 

‘‘Sec. 2143. Exercises. 

Sec. 302. Enhancing laboratory biosecurity. 

Sec. 303. Definitions. 

Sec. 304. Dual-use terrorist risks from synthetic biology. 

Sec. 305. Dissemination of information analyzed by the Department to State, local, tribal, and private entities 

with responsibilities relating to homeland security. 

TITLE IV—PUBLIC HEALTH MATTERS 

Sec. 401. Sense of Congress regarding Federal coordination on medical countermeasures. 

Sec. 402. National Medical Countermeasure Dispensing Strategy. 

‘‘Sec. 319F–5. National Medical Countermeasure Dispensing Strategy. 

Sec. 403. National pre-event vaccination and antimicrobial dispensing policy review. 

Sec. 404. Management of short shelf life vaccine and antimicrobial stockpiles. 

Sec. 405. Material threat determinations reviews. 

Sec. 406. Background checks. 

Sec. 407. State, local, and tribal defined. 

TITLE V—FOREIGN RELATIONS MATTERS 

Sec. 501. International engagement to enhance biodefense and laboratory biosecurity. 

Sec. 502. International collaboration and information sharing relating to biosecurity. 

Sec. 503. Interagency task force on best practices for global biopreparedness. 

Sec. 504. Biological and Toxin Weapons Convention. 

SEC. 2. DEFINITIONS. 

In this Act: 

(1) The term ‘‘appropriate congressional committees’’ means the Committee on 

Homeland Security of the House of Representatives and any committee of the 

House of Representatives or the Senate having legislative jurisdiction under the 

rules of the House of Representatives or Senate, respectively, over the matter 

concerned. 


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(2) The term ‘‘Intelligence Community’’ has the meaning given that term in 

section 3(4) of the National Security Act of 1947 (50 U.S.C. 401a(4)). 

(3) The term ‘‘national biosecurity and biodefense stakeholders’’ means officials from the Federal, State, local, and tribal authorities and individuals and 

other persons from the private sector who are involved in efforts to prevent, protect against, respond to, and recover from a biological attack or other phenomena that may have serious health consequences for the United States, including wide-scale fatalities or infectious disease outbreaks. 

TITLE I—A NATIONAL BIODEFENSE 

ENTERPRISE 

SEC. 101. SPECIAL ASSISTANT FOR BIODEFENSE. 

(a) IN GENERAL.—The President shall assign a member of the National Security 

Council to serve as Special Assistant to the President for Biodefense, who shall— 

(1) serve as the principal advisor to the President regarding coordination of 

Federal biodefense policy including prevention, protection, response, and recovery from biological attacks or other phenomena that may have serious health 

consequences for the United States, including wide-scale fatalities or infectious 

disease outbreaks; 

(2) identify gaps, duplication, and other inefficiencies in existing biodefense 

activities and the actions necessary to overcome these obstacles; 

(3) lead the development of a coordinated National Biodefense Plan, in accordance with section 102; 

(4) lead the development of a coordinated National Biosurveillance Strategy, 

in accordance with section 103; 

(5) lead the development of a coordinated national research and development 

strategy and implementation plan for microbial forensics, the latter to be updated not less than once every 4 years; 

(6) oversee, in coordination with the Director of the Office of Management and 

Budget, the development of a comprehensive cross-cutting biodefense budget 

analysis to inform prioritization of resources and ensure that biodefense challenges are adequately addressed, in accordance with section 104; and 

(7) conduct ongoing oversight and evaluation of implementation of Federal 

biodefense activities by relevant Government departments and agencies. 

(b) ACCESS BY CONGRESS.—The appointment of the Special Assistant to the President for Biodefense shall not be construed as affecting access by Congress or committees of either House of Congress to information, documents, and studies in the 

possession of, or conducted by or at the direction of, the Special Assistant. 

SEC. 102. NATIONAL BIODEFENSE PLAN. 

The Special Assistant to the President for Biodefense shall submit to the President a National Biodefense Plan that— 

(1) defines the scope and purpose of a national biodefense capability; 

(2) identifies biological risks to the Nation to be addressed by the Plan, consistent with section 2102 of the Homeland Security Act of 2002, as amended by 

this Act; 

(3) delineates activities and tasks to be performed, including prevention, protection, response, and recovery activities, to address the risks identified under 

paragraph (2); 

(4) defines research and development needs for improving the capacity for 

threat awareness and prevention, protection, response, and recovery; 

(5) identifies biodefense assets, interdependencies, capability gaps, and gaps 

in the integration of capabilities; 

(6) provides goals, activities, milestones, and performance measures; 

(7) identifies resource and investment needs; 

(8) defines organizational roles, responsibilities , and coordination of Federal, 

State, local, and tribal authorities (as those terms are defined in the Homeland 

Security Act of 2002 (6 U.S.C. 101 et seq.)) with respect to the activities and 

tasks delineated in paragraph (3); 

(9) integrates and supports the strategies outlined in Presidential Policy Directives 2 and 8 and Homeland Security Presidential Directives 5, 9, 10, 18, 21, 

and their successors, the National Biosurveillance Strategy published under section 103 of this Act, the National Medical Countermeasure Dispensing Strategy 

developed under section 319F–5 of the Public Health Service Act, as amended 

by this Act, and other strategy documents as appropriate; 


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(10) is consistent with the National Response Framework as published by the 

Secretary of Homeland Security in January 2008, and any successors thereof; 

(11) incorporates input from Federal, State, local, and tribal stakeholders; 

(12) provides planning guidance to biosecurity and biodefense stakeholders, 

including leveraging of existing guidance; and 

(13) shall be submitted to the President and the Congress within 18 months 

after the date of the enactment of this Act, and updated as necessary. 

SEC. 103. NATIONAL BIOSURVEILLANCE STRATEGY. 

(a) STRATEGY FOR BIOSURVEILLANCE.—The Special Assistant to the President for 

Biodefense shall publish a National Biosurveillance Strategy that shall— 

(1) identify the purpose and scope of a nationally integrated biosurveillance 

capability; 

(2) establish goals, objectives, priorities, milestones, and performance measures to guide the development of such capability; 

(3) define and prioritize costs, benefits, and resource and investment needs, 

with particular attention to leveraging existing resources; 

(4) delineate Federal, State, local, tribal, and private roles and responsibilities; and 

(5) describe how the Strategy is integrated with related national strategies. 

(b) MATTERS FOR CONSIDERATION.—In developing the strategy required under subsection (a), the Special Assistant shall take into consideration— 

(1) the state of biosurveillance domestically and internationally; 

(2) material threat assessments and determinations developed by the Secretary of Homeland Security in accordance with the Project BioShield Act of 

2004 (Public Law 108–276) and the amendments made by that Act; 

(3) risk assessments consistent with section 2102 of the Homeland Security 

Act of 2002, as amended by this Act; 

(4) reports on global trends produced by the Office of the Director of National 

Intelligence regarding the biological threat; 

(5) Intelligence Community needs as articulated in relevant intelligence strategies; 

(6) information available in biosurveillance systems and changes to information technology including systems used commercially to allow for the incorporation and integration of this information; and 

(7) costs associated with establishing and maintaining the necessary infrastructure to integrate biosurveillance systems. 

(c) IMPLEMENTATION PLAN.—In addition to the strategy required under subsection 

(a), the Special Assistant shall publish an implementation plan for such strategy 

that includes benchmarks for measuring the success of the Strategy. The implementation plan shall— 

(1) include a plan for advancing situational awareness of biological threats, 

by rapid detection and dissemination of biosurveillance information in real time, 

and through other means; 

(2) include a plan for fostering information sharing among national biosecurity and biodefense stakeholders— 

(A) to identify potential threats, reduce vulnerabilities, and improve collective response activities to, and investigations of, suspected biological attacks; 

(B) that addresses the type of information to be shared and how it will 

be shared; and 

(C) that identifies critical sensitivities to be protected; and 

(3) include a plan for enhancing the capability of the Federal Government to 

rapidly identify, characterize, localize, and track a biological event of national 

concern by integrating and analyzing data relating to human health, animal, 

plant, food, and environmental monitoring systems (both national and international). 

(d) DEADLINE; SUBMISSION; UPDATES.—The Special Assistant shall— 

(1) publish the strategy, and submit it to the appropriate congressional committees, by not later than 1 year after the date of enactment of this Act; and 

(2) publish an implementation plan for such strategy not later than 2 years 

after the date of enactment of this Act, and update the implementation plan at 

least once every 4 years. 

SEC. 104. COMPREHENSIVE CROSS-CUTTING BIODEFENSE BUDGET ANALYSIS. 

(a) IN GENERAL.—In order to enhance strategic planning, eliminate redundancies, 

identify capability gaps, and provide for greater transparency, the Special Assistant 

to the President for Biodefense, in coordination with the Director of the Office of 

Management and Budget, shall transmit to the appropriate congressional committees, concurrent with the submission of the President’s annual budget to the ConVerDate Mar 15 2010 04:40 Sep 15, 2012 Jkt 019006 PO 00000 Frm 00004 Fmt 6659 Sfmt 6621 E:\HR\OC\HR665P1.XXX HR665P1

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gress, a comprehensive cross-cutting biodefense budget analysis that delineates and 

integrates the biodefense expenditure requests for the departments and agencies 

headed by the officials listed in subsection (c). 

(b) CONTENTS.— 

(1) IN GENERAL.—The comprehensive cross-cutting biodefense budget analysis 

shall provide a detailed, separate analysis, by budget function, by department 

or agency, and by initiative area (as determined by the Administration), for the 

prior fiscal year, the current fiscal year, and the fiscal years for which the budget is submitted, identifying the amounts of gross and net appropriations or 

obligational authority and outlays that contribute to biodefense, with separate 

displays for mandatory and discretionary amounts, including— 

(A) summaries of the total amount of such appropriations or obligational 

authority and outlays requested for biodefense; 

(B) an estimate of the current service levels of biodefense spending; and 

(C) an indication of how the Federal activities or accounts covered by the 

analysis support the activities delineated in the National Biodefense Plan 

under section 102(2). 

(2) ACCOUNT-LEVEL AMOUNTS.—With respect to subparagraphs (A) through 

(C) of paragraph (1), amounts shall be provided by account for each program, 

project, and activity. 

(c) COORDINATION.— 

(1) SUBMISSION TO SPECIAL ASSISTANT.—Each official listed in paragraph (2) 

shall, by not later than 30 days before submitting the annual appropriations request for the agency under section 1108 of title 31, United States Code, submit 

to the Special Assistant— 

(A) the proposed appropriations request; and 

(B) a progress report on how the department or agency under the official’s 

authority agency has met the responsibilities of the official under the National Biodefense Plan under section 102. 

(2) COVERED OFFICIAL.—The officials referred to in paragraph (1) are— 

(A) the Secretary of Agriculture; 

(B) the Secretary of Commerce; 

(C) the Secretary of Defense; 

(D) the Secretary of Energy; 

(E) the Secretary of Health and Human Services; 

(F) the Secretary of Homeland Security; 

(G) the Secretary of State; 

(H) the Secretary of Veterans Affairs; 

(I) the Attorney General; 

(J) the Administrator of the Environmental Protection Agency; 

(K) the Director of the National Science Foundation; 

(L) the Postmaster General of the United States; and 

(M) heads of other Federal departments and agencies as considered appropriate by the Special Assistant. 

(d) CONSULTATION WITH CONGRESS.—Periodically, but at least annually, the Special Assistant for Biodefense shall consult with the Committee on Homeland Security of the House of Representatives, the Committee on Homeland Security and Governmental Affairs of the Senate, the Budget Committees of the House of Representatives and the Senate, the Appropriations Committees of the House of Representatives and the Senate, and the Congressional Budget Office. 

TITLE II—INTELLIGENCE MATTERS 

SEC. 201. NATIONAL INTELLIGENCE STRATEGY FOR COUNTERING THE THREAT FROM WEAPONS OF MASS DESTRUCTION. 

(a) STRATEGY.— 

(1) DEVELOPMENT.—The Director of National Intelligence, in consultation 

with the Secretary of Homeland Security and the heads of other appropriate 

Federal departments and agencies, shall develop and implement— 

(A) a strategy designed to improve the capabilities of the United States 

to collect, analyze, and disseminate intelligence related to weapons of mass 

destruction; and 

(B) a plan to implement such strategy. 

(2) TITLE.—The strategy required under paragraph (1) shall be known as the 

‘‘National Intelligence Strategy for Countering the Threat from Weapons of 

Mass Destruction’’. 

(b) CONTENTS.—The strategy required under subsection (a) shall— 


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(1) identify and address core capabilities needed for successful intelligence collection on weapons of mass destruction; 

(2) include methods for the recruitment, training, and retention of a workforce 

with expertise in the collection, analysis, and dissemination of intelligence related to all types of weapons of mass destruction and science and technology 

related to weapons of mass destruction, as well as expertise in science and technology relating to risks posed by weapons of mass destruction; and 

(3) include methods for information sharing and collaboration, as appropriate, 

with non-Federal national biosecurity and biodefense stakeholders. 

(c) IMPLEMENTATION PLAN.—The plan for implementing the strategy required 

under subsection (a) shall include— 

(1) actions necessary to increase the effectiveness and efficiency of the sharing 

of intelligence on weapons of mass destruction throughout the Intelligence Community and with other Federal partners, including a description of statutory, 

regulatory, policy, technical, security, or other barriers that impede such sharing, and, as appropriate, the development of uniform standards across the Intelligence Community for such sharing; 

(2) methods to disseminate intelligence products to national biosecurity and 

biodefense stakeholders in classified and unclassified formats to increase the effectiveness and efficiency of the sharing of information; 

(3) actions necessary to provide open-source intelligence relating to weapons 

of mass destruction to— 

(A) appropriate Federal departments and agencies; 

(B) State, local, and tribal authorities; and 

(C) private entities; 

(4) specific objectives to be accomplished, with corresponding schedule, for 

each year of the 5-year period that begins on the date on which the strategy 

is submitted to the appropriate congressional committees under subsection (e) 

and tasks to accomplish such objectives, including— 

(A) a list prioritizing such objectives and such tasks; and 

(B) a schedule for meeting such objectives and carrying out such tasks; 

(5) assignments of roles and responsibilities to elements of the Intelligence 

Community to implement the strategy; and 

(6) a schedule for assessment of the effectiveness and efficiency of the strategy, including metrics, and a description of the components of the assessment. 

(d) COORDINATION.—The Director of National Intelligence shall coordinate with 

State, local, and tribal government authorities, the private sector, and nongovernmental organizations in the development of the National Intelligence Strategy for 

Countering the Threat from Weapons of Mass Destruction. 

(e) DEADLINE FOR SUBMISSION.—Not later than 6 months after the date of the enactment of this Act, the Director of National Intelligence shall submit to the appropriate congressional committees the strategy and plan required under subsection 

(a). The submission shall be in unclassified form but with a classified annex, as appropriate. 

(f) UPDATES.—The Director of National Intelligence shall update the implementation plan at least once every 4 years. 

SEC. 202. NATIONAL INTELLIGENCE STRATEGY FOR COUNTERING BIOLOGICAL THREATS. 

(a) STRATEGY.— 

(1) DEVELOPMENT.—The Director of National Intelligence, in consultation 

with the Secretary of Homeland Security, the Secretary of Health and Human 

Services, the Secretary of Agriculture, the Special Assistant to the President for 

Biodefense, and the heads of other appropriate Federal departments and agencies, shall develop and implement a strategy and a plan for implementing the 

strategy that is integrated into the National Intelligence Strategy for Countering the Threat from Weapons of Mass Destruction, as required under this 

title. 

(2) TITLE.—The strategy required under paragraph (1) shall be known as the 

‘‘National Intelligence Strategy for Countering Biological Threats’’. 

(b) CONTENTS.—The strategy required under subsection (a) shall— 

(1) identify and address target capabilities needed for successful intelligence 

collection on biological threats; 

(2) include a plan for establishing in the Intelligence Community a cadre of 

collectors and analysts in all relevant agencies in the Intelligence Community 

that are familiar with biological threats, biological science, and biotechnology, 

including— 

(A) biological scientists; 

(B) biotechnologists; and 


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(C) experts with knowledge of the current state of technologies that could 

be used to develop a weapon of mass destruction; 

(3) include a plan for defining the functions, capabilities, and gaps in the Intelligence Community workforce with respect to assessing the biological threat; 

(4) include methods for collaboration— 

(A) with non-Intelligence Community technical experts within Federal departments and agencies; and 

(B) as appropriate, with individuals with expertise described in paragraph (2) who are not employed by the Federal Government, in particular 

with State and local biodefense stakeholders; 

(5) include a plan for defining, integrating, focusing, and enhancing existing 

capabilities in the Intelligence Community dedicated to current and strategic biological threats; and 

(6) include a plan for ensuring the prioritization and sustained commitment 

of intelligence personnel and resources to address biological threats. 

(c) IMPLEMENTATION PLAN.—The implementation plan for the strategy required 

under subsection (a) shall— 

(1) include actions necessary to increase the effectiveness and efficiency of the 

sharing of intelligence throughout the Intelligence Community on biological 

weapons and organisms that could be used for biological terrorism, including a 

description of statutory, regulatory, policy, technical, security, or other barriers 

that prevent such sharing, and, as appropriate, the development of uniform 

standards across the Intelligence Community for such sharing; 

(2) address strategic and tactical human intelligence, measurement and signature intelligence, technical intelligence, medical intelligence, and open-source 

intelligence activities necessary to implement the strategy; 

(3) identify specific objectives to be accomplished during each year of the 5- 

year period that begins on the date on which the strategy is submitted to the 

appropriate congressional committees under subsection (d) and tasks to accomplish such objectives, including— 

(A) a list prioritizing such objectives and such tasks; and 

(B) a schedule for meeting such objectives and carrying out such tasks; 

(4) assign roles and responsibilities to elements of the Intelligence Community to implement the strategy; 

(5) a schedule for assessment of the effectiveness and efficiency of the strategy, including metrics; and 

(6) a schedule for evaluating on a regular basis the efforts of the Intelligence 

Community and progress on understanding and countering biological threats. 

(d) REPORT.—Not later than 1 year after the date of the enactment of this Act, 

the Director of National Intelligence shall submit to the appropriate congressional 

committees the strategy and plan required under subsection (a). The report shall 

be in unclassified form but with a classified annex, as appropriate. 

(e) UPDATES.—The Director of National Intelligence shall update the implementation plan at least once every 4 years. 

SEC. 203. STATE, LOCAL, AND TRIBAL DEFINED. 

In this title, the term ‘‘State, local, and tribal’’ has the same meaning that term 

has in the Homeland Security Act of 2002 (6 U.S.C. 101 et seq.). 

TITLE III—HOMELAND SECURITY MATTERS 

SEC. 301. WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS. 

(a) IN GENERAL.—The Homeland Security Act of 2002 (6 U.S.C. 101 et seq.) is 

amended by adding at the end the following new title: 

‘‘TITLE XXI—WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS 

‘‘Subtitle A—Prevention 

‘‘SEC. 2101. WEAPONS OF MASS DESTRUCTION INTELLIGENCE AND INFORMATION SHARING. 

‘‘(a) IN GENERAL.—The Office of Intelligence and Analysis of the Department 

shall— 

‘‘(1) conduct intelligence and information sharing activities consistent with 

the National Intelligence Strategy for Countering the Threat from Weapons of 


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Mass Destruction under section 201 of the WMD Prevention and Preparedness 

Act of 2012 and the National Intelligence Strategy for Countering Biological 

Threats under section 202 of that Act; 

‘‘(2) support homeland security-focused intelligence analysis of terrorist actors, their claims, and their plans to conduct attacks involving chemical, biological, radiological, and nuclear materials against the Nation; 

‘‘(3) support homeland security-focused intelligence analysis of global infectious disease, public health, food, agricultural, and veterinary issues; 

‘‘(4) support homeland security-focused risk analysis and risk assessments of 

the homeland security hazards described in paragraphs (2) and (3), by providing 

relevant quantitative and nonquantitative threat information; 

‘‘(5) leverage existing and emerging homeland security capabilities and structures, including fusion centers established pursuant to section 210A, to enhance 

prevention, protection, response, and recovery efforts with respect to a chemical, 

biological, radiological, or nuclear attack; 

‘‘(6) share information and provide tailored analytical support on these 

threats to State, local, and tribal authorities as well as other national biosecurity and biodefense stakeholders; and 

‘‘(7) perform other responsibilities, as assigned by the Secretary. 

‘‘(b) COORDINATION.—Where appropriate, the Office of Intelligence and Analysis 

shall coordinate with other relevant Department components, others in the Intelligence Community, including the National Counter Proliferation Center, and other 

Federal, State, local, and tribal authorities, including officials from high-threat 

areas, and enable such entities to provide recommendations on optimal information 

sharing mechanisms, including expeditious sharing of classified information, and on 

how they can provide information to the Department. 

‘‘(c) REPORT.— 

‘‘(1) IN GENERAL.—Not later than 1 year after the date of the enactment of 

this section and annually thereafter, the Secretary shall report to the appropriate congressional committees on— 

‘‘(A) the intelligence and information sharing activities under subsection 

(a) and of all relevant entities within the Department to counter the threat 

from weapons of mass destruction; and 

‘‘(B) the Department’s activities in accordance with relevant intelligence 

strategies, including the National Intelligence Strategy for Countering the 

Threat from Weapons of Mass Destruction and the National Intelligence 

Strategy for Countering Biological Threats. 

‘‘(2) ASSESSMENT OF IMPLEMENTATION.—The report shall include— 

‘‘(A) a description of methods established to assess progress of the Office 

of Intelligence and Analysis in implementing this section; and 

‘‘(B) such assessment. 

‘‘SEC. 2102. RISK ASSESSMENTS. 

‘‘(a) IN GENERAL.—The Secretary, acting through the Under Secretary for Science 

and Technology, shall, in coordination with relevant Department components and 

other appropriate Federal departments and agencies— 

‘‘(1) produce and update periodically a terrorism risk assessment of chemical, 

biological, radiological, and nuclear threats; and 

‘‘(2) produce and update periodically an integrated terrorism risk assessment 

that assesses all of those threats and compares them against one another according to their relative risk. 

‘‘(b) METHODOLOGY.— 

‘‘(1) IN GENERAL.—The Secretary shall— 

‘‘(A) convene an interagency task force of relevant subject matter experts 

to assess the proposed methodology to be used for assessments required 

under subsection (a), and to provide recommendations to the Secretary as 

to the adequacy of such methodology; 

‘‘(B) conduct sensitivity analysis on each assessment to identify and 

prioritize research activities to close knowledge gaps; and 

‘‘(C) consider the evolving threat from an intelligent adversary. 

‘‘(2) INCLUSION IN ASSESSMENT.—Each assessment under subsection (a) shall 

include a description of the methodology used for the assessment. 

‘‘(c) USAGE.—The assessments required under subsection (a) shall be used to inform and guide risk management decisions, including— 

‘‘(1) the threat assessments and determinations by the Secretary regarding 

agents and toxins pursuant to section 319F–2 of the Public Health Service Act; 

‘‘(2) allocation of resources for research and development for chemical, biological, radiological, and nuclear attack prevention, protection, response, and recovery; 


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‘‘(3) prioritization of medical countermeasure research, development, acquisition, and distribution activities and other national strategic biodefense research; 

‘‘(4) tailored risk assessments and risk mitigation studies, as appropriate, on 

topics such as radiological materials security or the economic risks of a biological attack; and 

‘‘(5) other homeland security activities as determined appropriate by the Secretary and the heads of other agencies. 

‘‘(d) INPUT AND SHARING.—The Secretary shall, for each assessment required 

under subsection (a)— 

‘‘(1) seek input from national biosecurity and biodefense stakeholders, and 

other Federal, State, local, and tribal officials involved in efforts to prevent, protect, respond to, and recover from chemical, biological, radiological, and nuclear 

threats; 

‘‘(2) ensure that written procedures are in place to guide the interagency development of the assessments, including for input, review, and implementation 

purposes, among relevant Federal partners; 

‘‘(3) share the risk assessments with Federal, State, local and tribal officials 

with appropriate security clearances and a need for the information in the classified version; and 

‘‘(4) to the maximum extent practicable, make available an unclassified 

version for Federal, State, local, and tribal officials involved in prevention and 

preparedness for chemical, biological, radiological, and nuclear events. 

‘‘(e) WRITTEN PROCEDURES.—The Secretary shall establish written procedures for 

appropriate usage of the assessments required under subsection (a), including— 

‘‘(1) a description of the types of departmental activities for which the assessments should be considered; 

‘‘(2) the extent to which the findings of the assessments should play a role 

in such activities; 

‘‘(3) the point in planning processes at which the assessments should be considered; and 

‘‘(4) how users can access expertise within the Department to aid in interpretation of the results of the assessments. 

‘‘SEC. 2103. NATIONAL EXPORT ENFORCEMENT COORDINATION. 

‘‘(a) ESTABLISHMENT.—There shall be maintained in the Department the Export 

Enforcement Coordination Center, with capability for national export enforcement 

coordination that is managed by the Secretary and coordinates the export enforcement activities among the Department, the Department of Agriculture, the Department of Commerce, the Department of Defense, the Department of Energy, the Department of Justice, the Department of State, the Department of the Treasury, the 

Intelligence Community, and other Federal agencies as appropriate. 

‘‘(b) RESPONSIBILITIES.—The Center shall— 

‘‘(1) enhance Federal coordination for law enforcement counterproliferation investigations, including coordination and deconfliction with intelligence counterproliferation activities; 

‘‘(2) address licensing inquiries, reviews, requests, checks, and verifications; 

and 

‘‘(3) conduct outreach and provide training to the export trade community. 

‘‘SEC. 2104. COMMUNICATION OF THREAT INFORMATION. 

‘‘(a) FINDINGS.—Congress finds the following: 

‘‘(1) The Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism recommended that ‘the Federal Government should 

practice greater openness of public information so that citizens better understand the threat and the risk this threat poses to them’. 

‘‘(2) There are unique challenges for community preparedness for attacks from 

weapons of mass destruction. 

‘‘(b) COMMUNICATIONS PLAN.— 

‘‘(1) IN GENERAL.—The Administrator of the Federal Emergency Management 

Agency shall develop a communications plan designed to provide information to 

the public related to preventing, preparing for, responding to, and recovering 

from chemical, biological, radiological, and nuclear attacks; 

‘‘(2) CONSULTATION.—As appropriate, the Administrator of the Federal Emergency Management Agency shall consult with State, local, and tribal authorities 

and coordinate with other Federal departments and agencies in developing the 

communications plans under paragraph (1). 

‘‘(3) PRE-SCRIPTED MESSAGES AND MESSAGE TEMPLATES.— 

‘‘(A) IN GENERAL.—The Administrator of the Federal Emergency Management Agency shall develop and disseminate, through an alerts and warnings system, pre-scripted messages and message templates for State, local, 


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and tribal authorities so that those authorities can quickly and rapidly disseminate critical information to the public in anticipation of, during, or in 

the immediate aftermath of a chemical, biological, radiological, and nuclear 

attack, and to be included in the Department of Homeland Security’s lessons learned information sharing system. 

‘‘(B) DEVELOPMENT AND DESIGN.—The pre-scripted messages or message 

templates shall— 

‘‘(i) be developed in consultation with State, local, and tribal authorities and in coordination with other appropriate Federal departments 

and agencies; 

‘‘(ii) be designed to provide accurate, essential, and appropriate information and instructions to the population directly affected by an incident, including information regarding an evacuation, sheltering in 

place, hospital surge operations, health, and safety; 

‘‘(iii) be designed to provide accurate, essential, and appropriate information and instructions to children and other special needs populations within the population directly affected by an incident; 

‘‘(iv) be designed to provide accurate, essential, and appropriate information and instructions to emergency response providers and medical 

personnel responding to an incident; and 

‘‘(v) include direction for the coordination of Federal, State, local, and 

tribal communications teams. 

‘‘(C) COMMUNICATIONS FORMATS.—The Administrator shall develop prescripted messages or message templates under this paragraph in multiple 

formats to ensure delivery— 

‘‘(i) in cases where the usual communications infrastructure is unusable; 

‘‘(ii) to individuals with disabilities or other special needs and individuals with limited English proficiency; and 

‘‘(iii) to educational and childcare facilities, including daycare centers, 

grade schools, universities, hospitals, and elderly care facilities. 

‘‘(D) DISSEMINATION AND TECHNICAL ASSISTANCE.—The Administrator 

shall ensure that all pre-scripted messages and message templates developed under this paragraph are made available to State, local, and tribal authorities so that those authorities may incorporate them, as appropriate, 

into their emergency plans. The Administrator shall also make available 

relevant technical assistance to those authorities to support communications planning. 

‘‘(E) EXERCISES.—To ensure that the pre-scripted messages or message 

templates developed under this paragraph can be effectively utilized in a 

disaster or incident, the Administrator shall incorporate Federal, State, 

local, and tribal communications teams that deliver such pre-scripted messages or message templates into exercises, including those conducted under 

the National Exercise Program. 

‘‘(4) REPORT.—Not later than 1 year after the date of the enactment of this 

subsection, the Administrator of the Federal Emergency Management Agency 

shall submit to the appropriate congressional committees the communications 

plans required to be developed under this subsection, including pre-scripted 

messages or message templates developed in conjunction with the plans and a 

description of the means that will be used to deliver these messages during 

such incidents. 

‘‘(c) TERRORISM THREAT AWARENESS.— 

‘‘(1) TERRORISM THREAT AWARENESS.—The Secretary, in coordination with the 

Attorney General and heads of appropriate Federal agencies, shall for purposes 

of preparedness and collective response to terrorism and for other purposes— 

‘‘(A) ensure that homeland security information concerning terrorist 

threats is provided to State, local, and tribal authorities and the public 

within the United States, as appropriate; and 

‘‘(B) establish a process to optimize opportunities for qualified heads of 

State, local, and tribal government entities to obtain appropriate security 

clearances so that they may receive classified threat information when appropriate. 

‘‘(2) THREAT BULLETINS.— 

‘‘(A) IN GENERAL.—Consistent with the requirements of paragraph (1), the 

Secretary shall, on a timely basis, prepare unclassified threat bulletins on 

chemical, biological, radiological, and nuclear threats. 

‘‘(B) REQUIREMENTS.—Each assessment required under subparagraph (A) 

shall— 


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‘‘(i) include guidance to the public for preventing and responding to 

acts of terrorism arising from such threats; and 

‘‘(ii) be made available on the Internet Web site of the Department 

and other publicly accessible Internet Web sites, communication systems, and information networks. 

‘‘(3) GUIDANCE TO STATE, LOCAL, AND TRIBAL AUTHORITIES.—The Secretary, 

using information provided by the terrorism risk assessments under section 

2102 and material threat assessments and determinations under the Project 

BioShield Act of 2004 (Public Law 108–276) and the amendments made by that 

Act— 

‘‘(A) shall provide to State, local, and tribal authorities written guidance 

on communicating terrorism-related threats and risks to the public within 

their jurisdictions; and 

‘‘(B) shall identify and articulate the governmental rationale for identifying particular communities as being at heightened risk of exploitation. 

‘‘(4) USE OF EXISTING RESOURCES.—The Secretary shall use Internet Web 

sites, communication systems, and information networks in operation on the 

date of an assessment under this subsection, and shall coordinate with other 

heads of Federal departments and agencies to provide information through existing channels to satisfy the requirements of paragraph (2)(B)(ii). The Secretary shall provide guidance on how State, local, tribal, and private entities 

can partner with public television stations to disseminate information provided 

by the Department and shall provide information on best practices on disseminating information to residents of local communities, including leveraging public television stations. 

‘‘SEC. 2105. INDIVIDUAL AND COMMUNITY PREPAREDNESS FOR CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR ATTACKS. 

‘‘(a) IN GENERAL.—The Secretary, acting through the Administrator for the Federal Emergency Management Agency, shall assist State, local, and tribal authorities 

in improving and promoting individual and community preparedness and collective 

response to terrorist attacks involving chemical, biological, radiological, and nuclear 

materials against the United States by— 

‘‘(1) developing guidance and checklists of recommended actions for individual 

and community prevention and preparedness efforts and disseminating such 

guidance and checklists to communities and individuals; 

‘‘(2) updating new and existing guidance and checklists as appropriate; 

‘‘(3) disseminating to communities and individuals the guidance developed 

under section 2131, as appropriate; 

‘‘(4) providing information and training materials in support of individual and 

community preparedness efforts; 

‘‘(5) conducting individual and community preparedness outreach efforts; and 

‘‘(6) such other actions as the Secretary determines appropriate. 

‘‘(b) COORDINATION.—The Secretary shall coordinate with Federal departments 

and agencies and with private sector and nongovernmental organizations to promote 

individual and community preparedness and collective response to terrorist attacks 

involving chemical, biological, radiological, and nuclear materials against the United 

States. 

‘‘(c) BEST PRACTICES.—In compiling guidance for individual and community preparedness in order to carry out subsection (a)(4), the Secretary shall give due regard 

to best practices based on the experience of other agencies and countries and the 

expertise of academic institutions and nongovernmental organizations. 

‘‘Subtitle B—Protection 

‘‘SEC. 2121. DETECTION OF BIOLOGICAL ATTACKS. 

‘‘(a) PROGRAM.—The Secretary shall carry out a program to detect a biological attack or event that poses a high risk to homeland security. Through such program, 

the Secretary shall— 

‘‘(1) deploy detection capabilities to areas, based on high risks identified by 

Department assessments, to indicate the presence of biological agents; 

‘‘(2) consider multiple deployment strategies including surge capability; 

‘‘(3) provide information to participating laboratories and programs for their 

use in monitoring public health, and biological material or other data from 

those detectors to participating laboratories and programs for testing and evaluation; 

‘‘(4) regularly communicate with, and provide information about the presence 

of biological agents to, appropriate Federal, State, and local agencies responsible 


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for public health, law enforcement, and emergency services, in a manner that 

ensures transparency with the governments served by such personnel; 

‘‘(5) provide advanced planning tools, concepts of operations (including alarm 

resolution protocols and response guidance), standard operating procedures, and 

training exercises (including in collaboration with relevant national level exercises) for collective response to and recovery from biological attacks; and 

‘‘(6) provide technical assistance to jurisdictions hosting the program to improve their ability to respond to a detected pathogen. 

‘‘(b) PROGRAM REQUIREMENTS.—Under the program required under subsection (a), 

the Secretary shall— 

‘‘(1) enter into memoranda of agreement or interagency agreements under the 

Economy Act of 1933 (31 U.S.C. 1535 et seq.) with the Director of the Centers 

of Disease Control and Prevention and the Administrator of the Environmental 

Protection Agency, and the heads of other Federal departments and agencies, 

setting forth roles and responsibilities, including with respect to validating performance and developing testing protocols for participating laboratories and coordination with appropriate State, local, and tribal agencies; 

‘‘(2) establish criteria for determining whether plans for biological detector capabilities and coverage sufficiently protect the United States population, and 

make such determinations on an annual basis; 

‘‘(3) acting through the Under Secretary for Science and Technology, and in 

consultation with the Director of the Centers for Disease Control and Prevention, implement a process for establishing assay performance standards and 

evaluation for equivalency for biological threat assays, that— 

‘‘(A) evaluates biological threat detection assays, their protocols for use, 

and their associated response algorithms for confirmation of biological 

threat agents, taking performance measures and concepts of operation into 

consideration; 

‘‘(B) develops interagency peer-reviewed assay performance and equivalency standards based on the findings of the evaluation under subparagraph (A); 

‘‘(C) requires implementation of the standards developed under subparagraph (B) for all Department biological detection programs; 

‘‘(D) promotes use of such standards among all other Federal biological 

detection programs and makes them available to the private sector and 

other end-users as appropriate; and 

‘‘(E) is updated as necessary; 

‘‘(4) prior to obligating funds to acquire biodetection systems for purposes of 

operational testing and evaluation, require— 

‘‘(A) a determination of the sensitivity and specificity of the currently deployed biodetection system; 

‘‘(B) an assessment of the sensitivity and specificity of the next generation 

biodetection system or systems under consideration for acquisition and 

whether it meets established operational requirements; 

‘‘(C) provision of all raw data to the Science and Technology Directorate 

to enable the Under Secretary to— 

‘‘(i) conduct a trade-off study comparing the results of subparagraphs 

(A) and (B); and 

‘‘(ii) perform a technical readiness assessment in accordance with section 308(b); and 

‘‘(D) that the findings under subparagraph (C) inform the cost-benefit 

analysis under paragraph (5)(A) and any Departmental acquisition review 

board decision regarding the biodetection system or systems under consideration; and 

‘‘(5) prior to acquiring and deploying biodetection technology, require— 

‘‘(A) a cost-benefit analysis, including an analysis of alternatives, that 

shall be informed by the terrorism risk assessments under section 2102; 

‘‘(B) operational testing and evaluation; 

‘‘(C) operational assessment by the end users of the technology; and 

‘‘(D) the Department, other relevant executive agencies, and local jurisdictions intended to host the systems to agree on concepts of operations for 

resolving alarms. 

‘‘(c) CONTRACT AUTHORITY.—The Secretary may enter into contracts with participating laboratories and programs for— 

‘‘(1) the provision of laboratory services or other biosurveillance activities as 

appropriate for purposes of this section on a fee-for-service basis or on a prepayment or other similar basis; and 

‘‘(2) administrative and other costs related to hosting program personnel and 

equipment in these laboratories or programs. 


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‘‘(d) DEFINITIONS.—In this section: 

‘‘(1) The term ‘participating laboratory’ means a laboratory that has been accepted as a member of the Laboratory Response Network for Biological Terrorism that— 

‘‘(A) is fully equipped to detect and respond quickly to acts of biological 

terrorism; 

‘‘(B) provides biocontainment and microbiological analysis in support of 

the Department and relevant law enforcement agencies with responsibilities for investigating biological incidents; and 

‘‘(C) supports assay evaluation, research and development. 

‘‘(2) The term ‘assay’ means any scientific test that is designed to detect the 

presence of a biological threat agent that is of a type selected under criteria established by the Secretary. 

‘‘SEC. 2122. RAPID BIOLOGICAL THREAT DETECTION AND IDENTIFICATION AT PORTS OF 

ENTRY. 

‘‘(a) IN GENERAL.—The Secretary of Homeland Security shall require the Under 

Secretary for Science and Technology, in consultation with the heads of other relevant operational components of the Department of Homeland Security, to assess 

whether the development of technological screening capabilities for biological agents, 

pandemic influenza, and other infectious diseases should be undertaken by the Directorate of Science and Technology to support entry and exit screening at ports of 

entry and for other homeland security purposes. 

‘‘(b) DEVELOPMENT OF METHODS.—If the Under Secretary determines that the development of such screening capabilities should be undertaken, the Secretary shall, 

to the extent possible, initiate development of safe and effective methods to— 

‘‘(1) rapidly screen incoming persons at ports of entry for biological agents, 

pandemic influenza, and other infectious diseases; and 

‘‘(2) obtain results of such screening near the point of entry. 

‘‘SEC. 2123. EVALUATING DETECTION TECHNOLOGY. 

‘‘To inform the purchase of detection technology, the Secretary, in coordination 

with the Director of the National Institute of Standards and Technology, may carry 

out a program to— 

‘‘(1) establish near-term minimum performance metrics to support public safety actionable activities, based to the greatest extent practicable on voluntary 

consensus standards, to evaluate the effectiveness of detection technology for 

high-priority biological agents and toxins and high-priority chemical agents; 

‘‘(2) establish a process for voluntary testing and evaluation of technology by 

an accredited laboratory to demonstrate conformance to such consensus standards, or performance metrics if standards do not exist, for the effective detection 

of high-priority biological agents and toxins and high-priority chemical agents, 

including incentivization for the program through potential cost sharing with 

technology manufacturers and for SAFETY Act certification or placement on the 

authorized equipment list, or both; and 

‘‘(3) with permission from the detection technology manufacturer, make available to Federal departments and agencies, State, territorial, local, and tribal entities, and the private sector the results of detection system testing and evaluation under paragraph (2). 

‘‘SEC. 2124. DOMESTIC IMPLEMENTATION OF THE GLOBAL NUCLEAR DETECTION ARCHITECTURE. 

‘‘(a) SECURING THE CITIES.—The Director of the Domestic Nuclear Detection Office 

shall establish and maintain a multilayered system of detection technologies, programs, and guidelines designed to enhance the Nation’s ability to detect and prevent 

a radiological or nuclear attack in high-risk United States cities, as determined by 

the Secretary. 

‘‘(b) SURGE CAPABILITIES.—The Director shall develop a surge capability for radiological and nuclear detection systems that can be deployed within the United States 

rapidly in response to actionable intelligence or warnings, and includes procurement 

of appropriate technology, training, and exercises. 

‘‘(c) INTEGRATION.—The programs under subsections (a) and (b) shall be integrated 

into the Global Nuclear Detection Architecture and shall inform architecture studies, technology gaps, and research activities of the Domestic Nuclear Detection Office. 


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‘‘Subtitle C—Response 

‘‘SEC. 2131. FIRST RESPONDER GUIDANCE CONCERNING CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR ATTACKS. 

‘‘(a) ESTABLISHMENT OF VOLUNTARY GUIDANCE.—Not later than 1 year after the 

date of the enactment of this section, the Secretary, in coordination with the Secretary of Health and Human Services, the Secretary of Agriculture, the Administrator of the Environmental Protection Agency, the Attorney General, and the heads 

of other Federal departments and agencies, as appropriate, shall— 

‘‘(1) develop for police, fire, emergency medical services, emergency management, and medical and public health personnel, voluntary guidance for responding to a release of chemical, biological, radiological, and nuclear material; 

‘‘(2) make such guidance available to State, local, and tribal authorities, including primary and secondary schools and other educational institutions, nongovernmental organizations, the private sector, and the public; and 

‘‘(3) in developing the guidance under paragraph (1)— 

‘‘(A) review the experiences of other countries and the expertise of academic institutions and nongovernmental organizations; and 

‘‘(B) consider the unique needs of children and other vulnerable populations. 

‘‘(b) CONTENTS.—The guidance developed under subsection (a)(1) shall be voluntary, risk-based guidance that shall include— 

‘‘(1) protective action guidance for ensuring the security, health, and safety 

of emergency response providers and their families and household contacts; 

‘‘(2) specific information regarding the effects of the chemical, biological, radiological, or nuclear material on those exposed to the agent; and 

‘‘(3) best practices for emergency response providers to effectively diagnose, 

handle, and otherwise manage individuals affected by an incident involving 

chemical, biological, radiological, or nuclear material. 

‘‘(c) REVIEW AND REVISION OF GUIDANCE.—The Secretary shall— 

‘‘(1) review the guidance developed under subsection (a)(1) at least once every 

2 years; 

‘‘(2) make revisions to the guidance as appropriate; and 

‘‘(3) make any revised guidance available to State, local, and tribal authorities, nongovernmental organizations, the private sector, and the public. 

‘‘(d) PROCEDURES FOR DEVELOPING AND REVISING GUIDANCE.—In carrying out the 

requirements of this section, the Secretary shall establish procedures to— 

‘‘(1) enable members of the first responder and first provider community to 

submit recommendations of areas in which guidance is needed and could be developed under subsection (a)(1); 

‘‘(2) determine which entities should be consulted in developing or revising 

the guidance; 

‘‘(3) prioritize, on a regular basis, guidance that should be developed or revised; and 

‘‘(4) develop and disseminate the guidance in accordance with the 

prioritization under paragraph (3). 

‘‘SEC. 2132. INTEGRATED PLUME MODELING FOR COLLECTIVE RESPONSE. 

‘‘(a) DEVELOPMENT.— 

‘‘(1) IN GENERAL.—The Secretary shall acquire, use, and disseminate the best 

available integrated plume models to enable rapid response activities following 

a chemical, biological, nuclear, or radiological attack or event. 

‘‘(2) SCOPE.—The Secretary shall— 

‘‘(A) identify Federal, State, and local needs regarding plume models and 

ensure the rapid development and distribution of integrated plume models 

that meet those needs to appropriate officials of the Federal Government 

and State, local, and tribal authorities to enable immediate response to a 

chemical, biological, radiological, or nuclear attack or event; 

‘‘(B) establish mechanisms for dissemination by appropriate emergency 

response officials of the integrated plume models described in paragraph (1) 

to nongovernmental organizations and the public to enable appropriate collective response activities; 

‘‘(C) ensure that guidance and training in how to appropriately use such 

models are provided; and 

‘‘(D) ensure that lessons learned from assessing the development and dissemination of integrated plume models during exercises administered by 

the Department are put into the lessons learned information sharing system maintained by the Department. 


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‘‘(b) DEFINITIONS.—For purposes of this section: 

‘‘(1) The term ‘plume model’ means the assessment of the location and prediction of the spread of agents following a chemical, biological, radiological, or 

nuclear attack or event. 

‘‘(2) The term ‘integrated plume model’ means a plume model that integrates 

protective action guidance and other information as the Secretary determines 

appropriate. 

‘‘SEC. 2133. ESTABLISHMENT OF THE SYSTEM ASSESSMENT AND VALIDATION FOR EMERGENCY RESPONDERS (SAVER) PROGRAM. 

‘‘The Secretary shall carry out a program for system assessment and validation 

of emergency response equipment at the Department, to be known as the ‘SAVER 

Program’. The Secretary shall ensure that such program— 

‘‘(1) conducts objective, impartial, practitioner-relevant, and operationally oriented assessments and validations of commercial emergency responder equipment and systems, including hand-held detectors for chemical, biological, radiological, and nuclear agents; 

‘‘(2) prioritizes such evaluation based on the technical results obtained from 

the program established under section 2123, if available; 

‘‘(3) is supported by a network of scientists who, in coordination with subject 

matter experts, perform the assessment and validation activities using strict 

scientific and testing protocols; 

‘‘(4) provides results along with other relevant equipment information to the 

emergency response provider community in an operationally useful form; 

‘‘(5) provides information on equipment that falls within the categories listed 

in the Department’s authorized equipment list; 

‘‘(6) provides information that enables decision-makers and responders to better select, procure, use, and maintain emergency responder equipment; and 

‘‘(7) shares such information nationally with the emergency response provider 

community. 

‘‘SEC. 2134. PAYMENT FOR LABORATORY RESPONSE SERVICES. 

‘‘In carrying out their functions, responsibilities, authorities, and duties to counter 

biological terrorism, the Secretary, the Attorney General, and the heads of other 

participating Federal agencies are authorized, subject to the availability of appropriations, to enter into contracts with laboratories that comprise the Laboratory Response Network for Biological Terrorism and other federally networked laboratories 

that agree to participate in such a contract, for the provision of laboratory testing 

services on a fee-for-service basis or on a prepayment or other similar basis. Prior 

to entering into such a contract with any laboratory in the Laboratory Response 

Network for Biological Terrorism, the Secretary, the Attorney General, or the head 

of any other participating Federal agency shall inform the Centers for Disease Control and Prevention. 

‘‘SEC. 2135. BIOFORENSICS CAPABILITIES. 

‘‘(a) BIOFORENSICS ANALYSIS CENTER.—There is authorized in the Department a 

bioforensics analysis center to provide support for law enforcement and intelligencerelated investigations and actions to— 

‘‘(1) provide definitive bioforensics analysis in support of the executive agencies with primary responsibilities for preventing, deterring, responding to, attributing, and recovering from biological attacks; and 

‘‘(2) undertake other related bioforensics activities. 

‘‘(b) PAYMENT FOR SERVICES.—The center shall charge and retain fees to reimburse the cost of any service provided to an executive agency that requested such 

service. 

‘‘(c) DETAILEE PROGRAM.—Subject to the availability of appropriations, the Secretary may implement a program under which executive agencies as considered appropriate by the Secretary provide personnel, on a reimbursable basis, to the center 

for the purpose of— 

‘‘(1) providing training and other educational benefits for such stakeholders 

to help them to better understand the policies, procedures, and laws governing 

national bioforensics activities; and 

‘‘(2) bolstering the capabilities and information sharing activities of the 

bioforensics analysis center authorized under subsection (a) with national biosecurity and biodefense stakeholders. 

‘‘SEC. 2136. METROPOLITAN MEDICAL RESPONSE SYSTEM PROGRAM. 

‘‘(a) IN GENERAL.—The Secretary shall conduct a Metropolitan Medical Response 

System Program, that shall assist State and local governments in preparing for and 

responding to public health and mass casualty incidents resulting from acts of terrorism, natural disasters, and other man-made disasters. 


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‘‘(b) FINANCIAL ASSISTANCE.— ‘‘(1) AUTHORIZATION OF GRANTS.— ‘‘(A) IN GENERAL.—The Secretary, through the Administrator of the Federal Emergency Management Agency, may make grants under this section 

to State and local governments to assist in preparing for and responding 

to mass casualty incidents resulting from acts of terrorism, natural disasters, and other man-made disasters. 

‘‘(B) CONSULTATION.—In developing guidance for grants authorized under 

this section, the Administrator shall consult with the Chief Medical Officer. 

‘‘(2) USE OF FUNDS.—A grant made under this section may be used to support 

the integration of emergency management, health, and medical systems into a 

coordinated response to mass casualty incidents caused by any hazard, including— 

‘‘(A) to strengthen medical surge capacity; 

‘‘(B) to strengthen mass prophylaxis capabilities including development 

and maintenance of an initial pharmaceutical stockpile sufficient to protect 

first responders, their families, and immediate victims from a chemical or 

biological event, including the procurement of home medical kits that are 

approved pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.), as applicable; 

‘‘(C) to strengthen chemical, biological, radiological, nuclear, and explosive 

detection, response, and decontamination capabilities; 

‘‘(D) to develop and maintain mass triage and pre-hospital treatment 

plans and capabilities; 

‘‘(E) for planning; 

‘‘(F) to support efforts to strengthen information sharing and collaboration capabilities of regional, State, and urban areas in support of public 

health and medical preparedness; 

‘‘(G) for medical supplies management and distribution; 

‘‘(H) for training and exercises; 

‘‘(I) for integration and coordination of the activities and capabilities of 

public health personnel and medical care providers with those of other 

emergency response providers as well as other Federal agencies, the private 

sector, and nonprofit organizations, for the forward movement of patients; 

and 

‘‘(J) for such other activities as the Administrator provides. 

‘‘(3) ELIGIBILITY.— 

‘‘(A) IN GENERAL.—Except as provided in subparagraph (C), any jurisdiction that received funds through the Metropolitan Medical Response System Program in fiscal year 2009 shall be eligible to receive a grant under 

this section. 

‘‘(B) ADDITIONAL JURISDICTIONS.— 

‘‘(i) UNREPRESENTED STATES.— 

‘‘(I) IN GENERAL.—Except as provided in subparagraph (C), the 

Administrator may make grants under this section to the metropolitan statistical area with the largest population in any State in 

which no jurisdiction received funds through the Metropolitan 

Medical Response Program in fiscal year 2009, or in which funding 

was received only through another State. 

‘‘(II) LIMITATION.—For each of fiscal years 2012 through 2014, no 

jurisdiction that would otherwise be eligible to receive grants under 

subclause (I) shall receive a grant under this section if it would result in any jurisdiction under subparagraph (A) receiving less funding than such jurisdiction received in fiscal year 2009. 

‘‘(ii) OTHER JURISDICTIONS.— 

‘‘(I) IN GENERAL.—Subject to subparagraph (C), the Administrator may determine that additional jurisdictions are eligible to 

receive grants under this section. 

‘‘(II) LIMITATION.—For each of fiscal years 2012 through 2014, 

the eligibility of any additional jurisdiction to receive grants under 

this section is subject to the availability of appropriations beyond 

that necessary to— 

‘‘(aa) ensure that each jurisdiction eligible to receive a grant 

under subparagraph (A) does not receive less funding than 

such jurisdiction received in fiscal year 2009; and 

‘‘(bb) provide grants to jurisdictions eligible under clause (i). 

‘‘(C) PERFORMANCE REQUIREMENT AFTER FISCAL YEAR 2012.—A jurisdiction 

shall not be eligible for a grant under this subsection from funds available 


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after fiscal year 2012 unless the Secretary determines that the jurisdiction 

maintains a sufficient measured degree of capability in accordance with the 

performance measures issued under subsection (c). 

‘‘(4) DISTRIBUTION OF FUNDS.— ‘‘(A) IN GENERAL.—The Administrator shall distribute grant funds under 

this section to the State in which the jurisdiction receiving a grant under 

this section is located. 

‘‘(B) PASS THROUGH.—Subject to subparagraph (C), not later than 45 days 

after the date on which a State receives grant funds under subparagraph 

(A), the State shall provide the jurisdiction receiving the grant 100 percent 

of the grant funds, and not later than 45 days after the State releases the 

funds, all fiscal agents shall make the grant funds available for expenditure. 

‘‘(C) EXCEPTION.—The Administrator may permit a State to provide to a 

jurisdiction receiving a grant under this section 97 percent of the grant 

funds awarded if doing so would not result in any jurisdiction eligible for 

a grant under paragraph (3)(A) receiving less funding than such jurisdiction 

received in fiscal year 2009. 

‘‘(5) REGIONAL COORDINATION.—The Administrator shall ensure that each jurisdiction that receives a grant under this section, as a condition of receiving 

such grant, is actively coordinating its preparedness efforts with surrounding 

jurisdictions, with the official with primary responsibility for homeland security 

(other than the Governor) of the government of the State in which the jurisdiction is located, and with emergency response providers from all relevant disciplines, as determined by the Administrator, to effectively enhance regional 

preparedness. 

‘‘(c) PERFORMANCE MEASURES.—The Administrator of the Federal Emergency 

Management Agency, in coordination with the Chief Medical Officer, and the National Metropolitan Medical Response System Working Group, shall issue performance measures within 1 year after the date of enactment of this section that enable 

objective evaluation of the performance and effective use of funds provided under 

this section in any jurisdiction. 

‘‘(d) METROPOLITAN MEDICAL RESPONSE SYSTEM WORKING GROUP DEFINED.—In 

this section, the term ‘National Metropolitan Medical Response System Working 

Group’ means— 

‘‘(1) 10 Metropolitan Medical Response System Program grant managers, who 

shall— 

‘‘(A) include 1 such grant manager from each region of the Agency; 

‘‘(B) comprise a population-based cross section of jurisdictions that are receiving grant funds under the Metropolitan Medical Response System Program; and 

‘‘(C) include— 

‘‘(i) 3 selected by the Administrator of the Federal Emergency Management Agency; and 

‘‘(ii) 3 selected by the Chief Medical Officer; and 

‘‘(2) 3 State officials who are responsible for administration of State programs 

that are carried out with grants under this section, who shall be selected by the 

Administrator. 

‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated $42,000,000 to carry out the program for each of fiscal years 2012 through 2016. 

‘‘Subtitle D—Recovery 

‘‘SEC. 2141. IDENTIFYING AND ADDRESSING GAPS IN RECOVERY CAPABILITIES. 

‘‘(a) RISK ASSESSMENT.— ‘‘(1) TAILORED RISK ASSESSMENT.—The Secretary, acting through the Under 

Secretary for Science and Technology and in coordination with the Administrator of the Environmental Protection Agency, shall conduct tailored risk assessments to inform prioritization of national recovery activities for chemical, 

biological, radiological, and nuclear incidents, to be updated as necessary. 

‘‘(2) CONSIDERATIONS.—In conducting the risk assessments under paragraph 

(1), the Secretary shall— 

‘‘(A) consult with the Secretary of Health and Human Services, the Secretary of Agriculture, the Secretary of the Interior, the Chairman of the Nuclear Regulatory Commission, and the heads of other relevant Federal departments and agencies; 

‘‘(B) consider recovery of both indoor areas and outdoor environments; 

and 


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‘‘(C) consider relevant studies previously prepared by other Federal agencies, or other appropriate stakeholders. 

‘‘(3) COLLABORATION.—Upon completion of the risk assessments required by 

this section, the Secretary shall provide the findings to the Administrator of the 

Environmental Protection Agency and heads of other relevant Federal agencies 

in order to inform ongoing and future work, including research and guidance 

development, undertaken by those agencies in recovery and remediation from 

chemical, biological, radiological, or nuclear incidents. 

‘‘(b) RESEARCH.—The results of the risk assessment under this section shall inform appropriate Federal research to address the high-risk capability gaps uncovered by each assessment. 

‘‘(c) SUBMISSION TO CONGRESS.—The results of each risk assessment shall be submitted to the appropriate congressional committees within 30 days after completion 

of the assessment. 

‘‘SEC. 2142. RECOVERY FROM A CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR ATTACK OR INCIDENT. 

‘‘(a) ESTABLISHMENT OF GUIDANCE.—The Secretary shall develop and issue guidance for clean-up and restoration of indoor and outdoor areas, including subways 

and other mass transportation facilities, that have been exposed to chemical, biological, radiological, or nuclear materials. The Secretary shall develop and issue the 

guidance, within 24 months after the date of enactment of this section, in consultation with— 

‘‘(1) the Secretary of Agriculture; 

‘‘(2) the Secretary of Commerce; 

‘‘(3) the Secretary of Education; 

‘‘(4) the Secretary of the Interior; 

‘‘(5) the Attorney General; 

‘‘(6) the Secretary of Labor; 

‘‘(7) the Secretary of Transportation; 

‘‘(8) the Secretary of Housing and Urban Development; 

‘‘(9) the Secretary of Health and Human Services; 

‘‘(10) the Secretary of Veterans Affairs; 

‘‘(11) the Secretary of the Treasury; 

‘‘(12) the Administrator of the Environmental Protection Agency; and 

‘‘(13) the Administrator of the Small Business Administration. 

‘‘(b) CONTENTS.—The guidance developed under subsection (a) shall clarify Federal 

roles and responsibilities for assisting State, local, and tribal authorities and include 

risk-based recommendations for— 

‘‘(1) standards for effective decontamination of affected sites; 

‘‘(2) standards for safe post-event occupancy of affected sites, including for 

vulnerable populations such as children and individuals with health concerns; 

‘‘(3) requirements to ensure that the decontamination procedures for responding organizations do not conflict; 

‘‘(4) requirements that each responding organization uses a uniform system 

for tracking costs and performance of clean-up contractors; 

‘‘(5) maintenance of negative air pressure in buildings; 

‘‘(6) standards for proper selection and use of personal protective equipment; 

‘‘(7) air sampling procedures; 

‘‘(8) development of occupational health and safety plans that are appropriate 

for the specific risk to responder health; and 

‘‘(9) waste disposal. 

‘‘(c) REVIEW AND REVISION OF GUIDANCE.—The Secretary shall— 

‘‘(1) not less frequently than once every 2 years, review the guidance developed under subsection (a); 

‘‘(2) make revisions to the guidance as appropriate; and 

‘‘(3) make the revised guidance available to the Federal Government, State, 

local, and tribal authorities, nongovernmental organizations, the private sector, 

and the public. 

‘‘(d) PROCEDURES FOR DEVELOPING AND REVISING GUIDANCE.—In carrying out the 

requirements of this section, the Secretary shall establish procedures to— 

‘‘(1) prioritize issuance of guidance based on the results of the risk assessment 

under section 2131; 

‘‘(2) inventory existing relevant guidance; 

‘‘(3) enable the public to submit recommendations of areas in which guidance 

is needed; 

‘‘(4) determine which entities should be consulted in developing or revising 

the guidance; 

‘‘(5) prioritize, on a regular basis, guidance that should be developed or revised; and 


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‘‘(6) develop and disseminate the guidance in accordance with the 

prioritization under paragraph (5). 

‘‘(e) CONSULTATIONS.—The Secretary shall develop and revise the guidance developed under subsection (a), and the procedures required under subsection (d), in consultation with— 

‘‘(1) the heads of other Federal departments and agencies that are not required to be consulted under subsection (a), as the Secretary considers appropriate; 

‘‘(2) State, local, and tribal authorities; and 

‘‘(3) nongovernmental organizations and private industry. 

‘‘(f) REPORT.—Not later than 1 year after the date of the enactment of this section, 

and annually thereafter, the Secretary shall provide appropriate congressional committees with— 

‘‘(1) a description of the procedures established under subsection (d); 

‘‘(2) any guidance in effect on the date of the report; 

‘‘(3) a list of entities to which the guidance described in paragraph (2) was 

disseminated; 

‘‘(4) a plan for reviewing the guidance described in paragraph (2), in accordance with subsection (e); 

‘‘(5) the prioritized list of the guidance required under subsection (d)(4), and 

the methodology used by the Secretary for such prioritization; and 

‘‘(6) a plan for developing, revising, and disseminating the guidance. 

‘‘SEC. 2143. EXERCISES. 

‘‘(a) IN GENERAL.—To facilitate recovery from a chemical, biological, radiological, 

or nuclear attack or other incident involving chemical, biological, radiological, or nuclear materials and to foster collective response to terrorism, the Secretary shall develop exercises in consultation with State, local, and tribal authorities and other appropriate Federal agencies, and, as appropriate, in collaboration with national level 

exercises, including exercises that address, to the best knowledge available at the 

time, analysis, indoor environmental cleanup methods, and decontamination standards, including those published in the guidance issued under section 2142. 

‘‘(b) LESSONS LEARNED FOR NATIONAL LEVEL EXERCISES.—The Secretary shall provide electronically, to the maximum extent practicable, lessons learned reports to 

each designated representative of State, local, and tribal jurisdictions and private 

sector entities that participate in National Level Exercises of the Department. Each 

lessons learned report shall be tailored to convey information on that exercise that 

could be leveraged to enhance preparedness and response.’’. 

(b) CLERICAL AMENDMENT.—The table of contents in section 1(b) of such Act is 

amended by adding at the end the following new items: 

‘‘TITLE XXI—WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS 

‘‘Subtitle A—Prevention 

‘‘Sec. 2101. Weapons of mass destruction intelligence and information sharing. 

‘‘Sec. 2102. Risk assessments. 

‘‘Sec. 2103. National Export Enforcement Coordination. 

‘‘Sec. 2104. Communication of threat information. 

‘‘Sec. 2105. Individual and community preparedness for chemical, biological, radiological, and nuclear attacks. 

‘‘Subtitle B—Protection 

‘‘Sec. 2121. Detection of biological attacks. 

‘‘Sec. 2122. Rapid biological threat detection and identification at ports of entry. 

‘‘Sec. 2123. Evaluating detection technology. 

‘‘Sec. 2124. Domestic implementation of the Global Nuclear Detection Architecture. 

‘‘Subtitle C—Response 

‘‘Sec. 2131. First responder guidance concerning chemical, biological, radiological, and nuclear attacks. 

‘‘Sec. 2132. Integrated plume modeling for collective response. 

‘‘Sec. 2133. Establishment of the system assessment and validation for emergency responders (SAVER) program. 

‘‘Sec. 2134. Payment for laboratory response services. 

‘‘Sec. 2135. Bioforensics capabilities. 

‘‘Sec. 2136. Metropolitan Medical Response System Program. 

‘‘Subtitle D—Recovery 

‘‘Sec. 2141. Identifying and addressing gaps in recovery capabilities. 

‘‘Sec. 2142. Recovery from a chemical, biological, radiological, and nuclear attack or incident. 

‘‘Sec. 2143. Exercises.’’. 

(c) CONFORMING AMENDMENT.—Section 316 of the Homeland Security Act of 2002 

(6 U.S.C. 195b), and the item relating to such section in section 1(b) of such Act, 

are repealed. 

(d) METROPOLITAN MEDICAL RESPONSE PROGRAM REVIEW.— 

(1) IN GENERAL.—The Administrator of the Federal Emergency Management 

Agency, the Chief Medical Officer of the Department of Homeland Security, and 


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the National Metropolitan Medical Response System Working Group shall conduct a review of the Metropolitan Medical Response System Program authorized 

under section 2136 of the Homeland Security Act of 2002, as added by this section, including an examination of— 

(A) the extent to which the program goals and objectives are being met; 

(B) the performance metrics that can best help assess whether the Metropolitan Medical Response System Program is succeeding; 

(C) how the Metropolitan Medical Response System Program can be improved; 

(D) how the Metropolitan Medical Response System Program complements and enhances other preparedness programs supported by the Department of Homeland Security and the Department of Health and Human 

Services; 

(E) the degree to which the strategic goals, objectives, and capabilities of 

the Metropolitan Medical Response System Program are incorporated in 

State and local homeland security plans; 

(F) how eligibility for financial assistance, and the allocation of financial 

assistance, under the Metropolitan Medical Response System Program 

should be determined, including how allocation of assistance could be based 

on risk; 

(G) implications for the Metropolitan Medical Response System Program 

if it were managed as a contractual agreement; and 

(H) the resource requirements of the Metropolitan Medical Response System Program. 

(2) REPORT.—Not later than 1 year after the date of enactment of this Act, 

the Administrator and the Chief Medical Officer shall submit to the Committee 

on Homeland Security of the House of Representatives and the Committee on 

Homeland Security and Governmental Affairs of the Senate a report on the results of the review under this section. 

(3) CONSULTATION.—The Administrator of the Federal Emergency Management Agency shall consult with the Secretary of Health and Human Services 

in the implementation of paragraph (1)(E). 

(4) DEFINITION.—In this subsection the term ‘‘National Metropolitan Medical 

Response System Working Group’’ has the meaning that term has in section 

2136 of the Homeland Security Act of 2002, as added by this section. 

SEC. 302. ENHANCING LABORATORY BIOSECURITY. 

(a) FEDERAL EXPERTS SECURITY ADVISORY PANEL.— 

(1) PANEL.— 

(A) ESTABLISHMENT.—The President shall establish a permanent advisory 

panel to be known as the Federal Experts Security Advisory Panel to make 

technical and substantive recommendations on biological agent and toxin 

security. 

(B) MEMBERSHIP.—The members of the Panel— 

(i) shall consist of the voting members appointed under subparagraph 

(D) and the nonvoting members appointed under subparagraph (E); and 

(ii) except as provided in subparagraph (E), shall each be an official 

or employee of the Federal Government. 

(C) CO-CHAIRS.—The voting members of the Panel appointed under 

clauses (i), (v), and (vi) of subparagraph (D) shall serve jointly as the CoChairs of the Panel. 

(D) VOTING MEMBERS.—The voting members of the Panel shall consist of 

1 voting representative of each of the following Government entities, appointed (except with respect to the National Security Council) by the head 

of the respective entity: 

(i) The Department of Agriculture. 

(ii) The Department of Commerce. 

(iii) The Department of Defense. 

(iv) The Department of Energy. 

(v) The Department of Health and Human Services. 

(vi) The Department of Homeland Security. 

(vii) The Department of Justice. 

(viii) The Department of Labor. 

(ix) The Department of State. 

(x) The Department of Transportation. 

(xi) The Department of Veterans Affairs. 

(xii) The Environmental Protection Agency. 

(xiii) The National Security Council, which shall be represented by 

the Special Assistant to the President for Biodefense. 


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(xiv) The Office of the Director of National Intelligence. 

(xv) Any other department or agency designated by the Co-Chairs. 

(E) NONVOTING MEMBERS.—The nonvoting members of the Panel shall 

consist of— 

(i) such additional representatives of the Government entities listed 

in subparagraph (D) as may be appointed by the heads of the respective 

entities; and 

(ii) a representative of the public health laboratory community or biological laboratory community (or both). 

(F) ADMINISTRATIVE SUPPORT.—The Secretary of Health and Human 

Services shall provide to the Panel such facilities, staff, and support services as may be necessary for the Panel to carry out its responsibilities 

under paragraph (2). 

(2) RESPONSIBILITIES.—Not later than 6 months after the date of the enactment of this section, the Panel shall, with respect to biological agent and toxin 

security, deliver to the Secretaries of Agriculture, Health and Human Services, 

and Homeland Security plurality recommendations, including any statements of 

dissent, concerning— 

(A) the designation as highest risk of that subset of biological agents and 

toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act 

(42 U.S.C. 262a(a)(1)) that presents the greatest risk of deliberate misuse 

with significant potential for mass casualties or devastating effects to the 

economy, informed by— 

(i) any biological or bioterrorism risk assessments conducted by the 

Department of Homeland Security and relevant assessments by other 

agencies; and 

(ii) determinations made by the Secretary of Homeland Security pursuant to section 319F–2(c)(2)(A) of such Act (42 U.S.C. 247d– 

6b(c)(2)(A)); 

(B) the development of a set of minimum risk-based prescriptive laboratory security performance standards based on the risk at the lowest level, 

allowing for enhancements as risk increases; 

(C) the establishment of appropriate standards and practices to improve 

vetting and monitoring of, and ensure reliability of, personnel with access 

to highest risk biological agents and toxins at facilities registered under 

section 351A(d) of the Public Health Service Act (42 U.S.C. 262a(d)); 

(D) the establishment of appropriate practices for physical security and 

cyber security for facilities that possess highest risk biological agents or 

toxins; 

(E) standards for training of laboratory personnel in security measures; 

(F) other emerging policy issues relevant to the security of biological 

agents and toxins; 

(G) adequacy of information sharing protocols with biodefense and biosecurity stakeholders; and 

(H) any other security standards determined necessary. 

(b) REVISION OF RULES AND REGULATIONS.— 

(1) PROPOSED RULES.—The Secretaries of Health and Human Services and 

Agriculture, in coordination with the Secretary of Homeland Security, no later 

than 1 year after the date of receipt of recommendations under subsection 

(a)(2), shall, as appropriate, propose rules under section 351A of the Public 

Health Service Act (42 U.S.C. 262a) establishing security standards and procedures that are specific to highest risk biological agents and toxins. 

(2) FINAL RULES.—The Secretaries of Health and Human Services and Agriculture, in coordination with the Secretary of Homeland Security, no later than 

24 months after the date of the enactment of this section, shall promulgate final 

rules described in paragraph (1). 

(c) COORDINATION OF FEDERAL OVERSIGHT.—To ensure that the Federal Government provides for comprehensive and effective oversight of biological agents and toxins security, the heads of the Government entities listed in subsection (a)(1)(D) shall 

for facilities in which the entity supports biological agent or toxin laboratory activities and by no later than 6 months after the submission of recommendations under 

subsection (a)(2), develop and implement a plan for the coordination of biological 

agents and toxins security oversight that— 

(1) articulates a mechanism for coordinated inspections of and harmonized administrative practices for facilities registered under section 351A(d) of the Public Health Service Act (42 U.S.C. 262a(d)), pursuant to subsection (d) of this section; and 

(2) ensures consistent and timely identification and resolution of biological 

agents and toxins security and compliance issues. 


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(d) COMMON INSPECTION PROCEDURES.—The heads of the entities listed in subsection (a)(1)(D) shall coordinate or consolidate laboratory inspections and ensure 

that such inspections are conducted using a common set of inspection procedures 

across such entities in order to minimize the administrative burden on such laboratory. 

(e) INSPECTION REPORTS.—Any inspection report resulting from an inspection described in paragraph (1) shall be available to— 

(1) each Federal agency that supports biological agent or toxin laboratory activities at the laboratory that is the subject of the inspection report; and 

(2) the laboratories that are the object of inspection. 

(f) LABORATORY BIOSECURITY INFORMATION SHARING.— (1) FEDERAL SHARING.—The Secretaries of Health and Human Services and 

Agriculture shall— 

(A) develop a process for sharing of information pertaining to biological 

agents and toxins with agencies that support biological agent or toxin laboratory activities, that identifies the purpose for sharing, and a mechanism 

for securing, such information; 

(B) share relevant information pertaining to biological agents and toxins, 

including identification of laboratories possessing highest risk biological 

agents and toxins, and compliance issues with the Secretary of Homeland 

Security; and 

(C) share relevant information pertaining to biological agents and toxins, 

including identification of laboratories possessing highest risk biological 

agents and toxins, with appropriate State, local, and tribal government authorities, including law enforcement authorities and emergency response 

providers. 

(2) CLASSIFIED AND SENSITIVE INFORMATION.—The Secretaries of Agriculture 

and Health and Human Services shall ensure that any information disseminated under this section is handled consistently with— 

(A) the authority of the Director of National Intelligence to protect intelligence sources and methods under the National Security Act of 1947 (50 

U.S.C. 401 et seq.) and related procedures or similar authorities of the Attorney General concerning sensitive law enforcement information; 

(B) section 552a of title 5, United States Code (commonly referred to as 

the ‘‘Privacy Act of 1974’’); and 

(C) other relevant laws. 

(g) DEFINITIONS.—In this section: 

(1) The terms ‘‘biological agent’’ and ‘‘toxin’’ refer to a biological agent or 

toxin, respectively, listed pursuant to section 351A(a)(1) of the Public Health 

Service Act (42 U.S.C. 262(a)(1)). 

(2) The term ‘‘highest risk’’ means, with respect to a biological agent or toxin, 

designated as highest risk as described in subsection (a)(2)(A). 

(3) The term ‘‘Panel’’ means the Federal Experts Security Advisory Panel 

under subsection (a). 

(4) The term ‘‘State, local, and tribal’’ has the same meaning that term has 

in the Homeland Security Act of 2002 (6 U.S.C. 101 et seq.). 

SEC. 303. DEFINITIONS. 

Section 2 of the Homeland Security Act of 2002 (6 U.S.C. 101) is amended by adding at the end the following new paragraphs: 

‘‘(19) The term ‘Intelligence Community’ has the meaning given that term in 

section 3(4) of the National Security Act of 1947 (50 U.S.C. 401a(4)). 

‘‘(20) The term ‘national biosecurity and biodefense stakeholders’ means officials from the Federal, State, local, and tribal authorities and individuals from 

the private sector who are involved in efforts to prevent, protect against, respond to, and recover from a biological attack or other biological incidents that 

may have serious health or economic consequences for the United States, including wide-scale fatalities or infectious disease outbreaks.’’. 

SEC. 304. DUAL-USE TERRORIST RISKS FROM SYNTHETIC BIOLOGY. 

(a) SENSE OF CONGRESS.—It is the sense of Congress that the field of synthetic 

biology has the potential to facilitate enormous gains in fundamental discovery, public health, and biotechnological applications, but that it also presents inherent dualuse homeland security risks that must be managed. 

(b) ASSESSMENT OF RISK.—Not less frequently than once every two years, the Secretary of Homeland Security, acting through the Under Secretary for Science and 

Technology, shall undertake a risk assessment of the dual-use and other risks associated with synthetic biology. 

(c) ESTABLISHMENT OF GUIDANCE.—Not later than six months after the date of the 

enactment of this Act, the Secretary shall develop and provide to the heads of all 


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departments and agencies that fund life sciences research, guidance on compliance 

with United States laws, arms control agreements to which the United States is a 

party or signatory, and individual department and agency policy, including consideration of— 

(1) best practices for establishing a department or agency process that 

achieves compliance for department or agency research, development, or acquisition projects in the life sciences; 

(2) the types of projects that should be assessed; 

(3) at what stage or stages such projects should be assessed; and 

(4) means for preventing the release of homeland or national security information. 

(d) RESEARCH AND DEVELOPMENT.—Based upon the findings of the risk assessment undertaken in accordance with subsection (b), the Under Secretary may conduct research into the risks and ways to mitigate such risks of synthetic biology, 

including— 

(1) determining the current capability of synthetic nucleic acid providers to 

effectively differentiate a legitimate customer from a potential terrorist or other 

malicious actor; 

(2) determining the current capability of synthetic nucleic acid providers to 

effectively screen orders for sequences of homeland security concern; and 

(3) making recommendations regarding screening software, protocols, and 

other remaining capability gaps uncovered by such risk assessment. 

SEC. 305. DISSEMINATION OF INFORMATION ANALYZED BY THE DEPARTMENT TO STATE, 

LOCAL, TRIBAL, AND PRIVATE ENTITIES WITH RESPONSIBILITIES RELATING TO 

HOMELAND SECURITY. 

Section 201(d)(8) of the Homeland Security Act of 2002 (6 U.S.C. 121(d)(8)) is 

amended by striking ‘‘and to agencies of State’’ and all that follows and inserting 

‘‘to State, local, tribal, and private entities with such responsibilities, and, as appropriate, to the public, in order to assist in preventing, deterring, or responding to acts 

of terrorism against the United States.’’. 

TITLE IV—PUBLIC HEALTH MATTERS 

SEC. 401. SENSE OF CONGRESS REGARDING FEDERAL COORDINATION ON MEDICAL COUNTERMEASURES. 

It is the sense of Congress that— 

(1) 10 years after the terrorist attacks of September 11, 2001, and 7 years 

after enactment of the Project BioShield Act of 2004 (Public Law 108–276), coordination among Federal agencies involved in activities relating to researching, 

developing, and acquiring medical countermeasures still needs improvement; 

and 

(2) aggressive action should be taken by the Department of Health and 

Human Services (in particular, the heads of the National Institutes of Health, 

the Biomedical Advanced Research and Development Authority, the Centers for 

Disease Control and Prevention, and the Food and Drug Administration), the 

Department of Homeland Security, and the Department of Defense to foster 

greater coordination with respect to such activities, including adoption of an 

interagency agreement that sets forth the relative areas of responsibility with 

respect to establishing medical countermeasure requirements and researching, 

developing, and acquiring medical countermeasures to meet those requirements. 

SEC. 402. NATIONAL MEDICAL COUNTERMEASURE DISPENSING STRATEGY. 

Title III of the Public Health Service Act is amended by inserting after section 

319F–4 (42 U.S.C. 247d–6e) the following: 

‘‘SEC. 319F–5. NATIONAL MEDICAL COUNTERMEASURE DISPENSING STRATEGY. 

‘‘(a) DEFINITIONS.—In this section— 

‘‘(1) the term ‘dispense’ means to provide medical countermeasures to an affected population in response to a threat or incident; and 

‘‘(2) the term ‘medical countermeasure’ means a qualified countermeasure (as 

defined in section 319F–1(a)(2)). 

‘‘(b) STRATEGY.— 

‘‘(1) IN GENERAL.—The Secretary, in coordination with the Secretary of Homeland Security, the Secretary of Agriculture, and other appropriate Federal agencies, shall develop, implement, and, as appropriate, periodically update a National Medical Countermeasure Dispensing Strategy to enhance preparedness 

and collective response to a terrorist attack on humans or animals with any 


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chemical, biological, radiological, or nuclear material, that delineates Federal, 

State, and local responsibilities. 

‘‘(2) CONSIDERATIONS.—The strategy shall be sufficiently flexible to meet the 

unique needs of different communities, including first responders, and shall consider— 

‘‘(A) a variety of options for dispensing medical countermeasures, including to individuals, schools, universities, hospitals, and elderly care facilities; 

‘‘(B) post-incident requirements for emergency use authorizations before 

countermeasures can be distributed legally; 

‘‘(C) the inclusion of locally held caches of countermeasures in event-specific authorizations covering federally held countermeasures of the same 

type; and 

‘‘(D) distribution to the public of home medical kits for personal stockpiling purposes, within 30 days after a domestic or international bioterrorist attack resulting in human infection. 

‘‘(c) COORDINATION.—The Secretary shall coordinate with the Administrator of the 

Federal Emergency Management Agency, State, local, and tribal authorities, representatives from the private sector, and nongovernmental organizations on the National Medical Countermeasures Dispensing Strategy. 

‘‘(d) REPORT.—Not later than 1 year after the date of the enactment of this section, the Secretary shall submit the National Medical Countermeasures Dispensing 

Strategy to the appropriate congressional committees.’’. 

SEC. 403. NATIONAL PRE-EVENT VACCINATION AND ANTIMICROBIAL DISPENSING POLICY REVIEW. 

(a) REQUIREMENT.—The Secretary of Health and Human Services, in coordination 

with the Secretary of Homeland Security and the Secretary of Agriculture, shall review the adequacy of domestic vaccination and antimicrobial dispensing policy, guidance, and information provided to the public in light of any known terrorist risk of 

a biological attack or other phenomena that may have serious health consequences 

for the United States, including wide-scale fatalities or infectious disease outbreaks 

including outbreaks associated with the avian flu. In carrying out the review under 

this section, the Secretary shall consider— 

(1) terrorism risk assessments under section 2102 of the Homeland Security 

Act of 2002, as amended by this Act, and material threat assessments and determinations under the Project Bioshield Act of 2004 (Public Law 108–276) and 

the amendments made by that Act; 

(2) reports on global trends and intelligence produced by the Office of the Director of National Intelligence and the Intelligence Community regarding biological threats; 

(3) the availability of federally provided vaccines and antimicrobials to dispense to first responders and the public, on a voluntary basis, in anticipation 

of a biological attack; 

(4) applicability of Federal shelf-life extension programs to locally held stockpiles of medical countermeasures, to the extent that information on local stockpiles is available; 

(5) making expiring products available to appropriate international organizations or foreign partners once the requests of domestic stakeholders have been 

fulfilled; 

(6) the implications of pre-event vaccination and antimicrobial dispensing to 

livestock; and 

(7) mechanisms to increase coordination between the Strategic National 

Stockpile established under section 319F–2 of the Public Health Service Act (42 

U.S.C. 247D–6b) and the National Veterinary Stockpile that would enhance vaccination and dispensing capabilities. 

(b) REPORT.—Not later than 1 year after the date of the enactment of this Act, 

the Secretary of Health and Human Services shall report to the appropriate congressional committees on the review required by subsection (a), together with any 

recommendations relating to the availability of domestic vaccine and antimicrobials 

for disbursing to the public and voluntary immunization by first responders. 

SEC. 404. MANAGEMENT OF SHORT SHELF LIFE VACCINE AND ANTIMICROBIAL STOCKPILES. 

The Secretary of Health and Human Services shall make available surplus vaccines and antimicrobials, and vaccines and antimicrobials with short shelf lives, 

from the strategic national stockpile under section 319F–2(a) of the Public Health 

Service Act (42 U.S.C. 247d–6b(a)) to State, local, and tribal first responders, including health care responders, for administration to such responders who voluntarily 

consent to such administration, and shall— 

(1) establish any necessary logistical and tracking systems to facilitate making such vaccines and antimicrobials so available; and 


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(2) distribute disclosures regarding associated risks to end users. 

SEC. 405. MATERIAL THREAT DETERMINATIONS REVIEWS. 

Section 319F–2(c)(2)(A) of the Public Health Service Act (42 U.S.C. Sec 247d6b(c)(2)(A)) is amended— 

(1) in clause (i), by striking ‘‘and’’ at the end; 

(2) by redesignating clause (ii) as clause (iii); 

(3) by inserting after clause (i) the following: 

‘‘(ii) establish criteria for the issuance of a material threat determination;’’; 

(4) in clause (iii), as so redesignated, by striking the period at the end and 

inserting ‘‘; and’’; and 

(5) by adding at the end the following: 

‘‘(iv) review and reassess determinations under clause (iii) to determine whether agents continue to present a material threat against the 

United States population sufficient to affect national security and 

homeland security.’’. 

SEC. 406. BACKGROUND CHECKS. 

Section 351A(e)(3)(A) of the Public Health Service Act (42 U.S.C. 262a(e)(3)(A)) is 

amended by adding at the end the following: ‘‘In identifying whether an individual 

is within a category specified in subparagraph (B)(ii)(II), the Attorney General shall 

consult with the Secretary of Homeland Security, the Secretary of Defense, and the 

Secretary of State to determine whether these officials possess any information relevant to the identification of such an individual by the Attorney General.’’. 

SEC. 407. STATE, LOCAL, AND TRIBAL DEFINED. 

In this title, the term ‘‘State, local, and tribal’’ has the same meaning that term 

has in the Homeland Security Act of 2002 (6 U.S.C. 101 et seq.). 

TITLE V—FOREIGN RELATIONS MATTERS 

SEC. 501. INTERNATIONAL ENGAGEMENT TO ENHANCE BIODEFENSE AND LABORATORY BIOSECURITY. 

The Secretary of State, in consultation with the Special Assistant to the President 

for Biodefense, and the heads of appropriate Federal agencies, shall, as appropriate— 

(1) support efforts of other countries to establish and build capacity to effectively implement legislation criminalizing the development or use of biological 

weapons or acts of bioterrorism; 

(2) engage other countries and international nongovernmental entities to develop and establish common standards, guidance, and best practices for actions 

relevant to preventing acts of bioterrorism and the illicit use of life sciences; 

(3) support the efforts of other countries to enhance biosecurity and safety 

practices at laboratories and other facilities with materials that could be used 

in biological weapons or in an act of bioterrorism; 

(4) promote the development and adoption of international guidance for the 

safety and security of high-risk pathogens and toxins; and 

(5) promote information sharing relating to threats and best practices between the intelligence community, Federal law enforcement, and international 

law enforcement and security officials. 

SEC. 502. INTERNATIONAL COLLABORATION AND INFORMATION SHARING RELATING TO BIOSECURITY. 

The Secretary of State, in consultation with the Secretary of Homeland Security, 

the Secretary of Agriculture, the Secretary of Health and Human Services, and the 

heads of other appropriate Federal agencies, shall, as appropriate— 

(1) support efforts in other countries and regions to develop mechanisms and 

capabilities for reporting to United Nations organizations validated data on biological attacks or other phenomena that may have serious health consequences 

for the United States, including wide-scale fatalities or infectious disease outbreaks; 

(2) engage other Federal and nongovernmental entities and other countries to 

advance awareness and understanding of the risk posed by information derived 

from the life sciences that has the potential for misuse to cause harm, and advance recommendations on how best to address such risk; 

(3) engage such entities and countries to promote greater awareness and understanding of the global availability of and access to life science technologies 

and materials; and 


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(4) promote the development and use of mechanisms for reporting, preserving, 

and sharing data on Federal programs and investments in international scientific, agricultural, medical, and public health collaborations in support of efforts to enhance global biosecurity. 

SEC. 503. INTERAGENCY TASK FORCE ON BEST PRACTICES FOR GLOBAL BIOPREPAREDNESS. 

(a) SENSE OF CONGRESS.—It is the sense of Congress that preparedness for a 

chemical, biological, radiological, or nuclear incident must be undertaken not only 

domestically but also internationally. Specifically, there is a need for a global preparedness architecture for such an event. Congress supports efforts to provide an 

international forum for discussion of key health security policies with international 

dimensions, and the establishment of a formal United States interagency task force 

to develop best practices and recommendations for implementation of a global preparedness architecture could enhance global preparedness. 

(b) ESTABLISHMENT OF TASK FORCE.—The Secretary of State shall convene and 

lead an interagency task force to examine— 

(1) the state of global biopreparedness for a major biological event; 

(2) necessary components of a global biopreparedness architecture that would 

advance international health security, including considerations of— 

(A) risk assessments; 

(B) prevention; 

(C) protection; 

(D) regional stockpiling of medical countermeasures, including considerations of— 

(i) security of the stockpile; 

(ii) preservation of the stockpile through effective detection and diagnosis, shelf life extension programs, and other means; 

(iii) delivery planning; and 

(iv) legal considerations for implementing such an architecture; 

(E) response and attribution; 

(F) other elements that should be a component of such an architecture; 

and 

(G) obstacles to implementing such an architecture; 

(3) best practices for preparedness based on lessons learned from domestic efforts to address the above issues, and that may be applicable internationally; 

(4) activities undertaken through the National Intelligence Strategy for Countering Biological Threats developed under section 202 and the International 

Health Regulations 2005, as well as other activities deemed relevant by the 

task force; and 

(5) the utility of working through existing international forums as a mechanism for distributing this information to the international community. 

(c) MEMBERSHIP.—Members of the task force shall include representatives from— 

(1) the Department of Homeland Security; 

(2) the Department of Health and Human Services, including the Centers for 

Disease Control and Prevention; 

(3) the Department of Agriculture; 

(4) the Department of Defense; 

(5) the Department of Justice; 

(6) the Department of State; 

(7) the Director of National Intelligence; 

(8) other Federal departments and agencies, as determined appropriate by the 

Secretary; and 

(9) national biosecurity and biodefense stakeholder community, including 

from the pharmaceutical and biotechnology industries, and the diagnostic laboratory community, as determined by the Secretary. 

(d) REPORT.—Not later than 1 year after the date of the enactment of this Act, 

the Secretary shall submit to the appropriate congressional committees a report on 

the findings of the task force established under this section. 

SEC. 504. BIOLOGICAL AND TOXIN WEAPONS CONVENTION. 

The Secretary of State shall— 

(1) promote confidence in effective implementation of and compliance with the 

Convention on the Prohibition of the Development, Production and Stockpiling 

of Bacteriological (Biological) and Toxin Weapons and on their Destruction 

(commonly referred to as the ‘‘Biological and Toxin Weapons Convention’’) by 

the States party to the Convention by promoting transparency with respect to 

legitimate activities and pursuing compliance diplomatically to address concerns; 

(2) promote universal membership in the Convention; 


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(3) develop an action plan for increasing international adherence to the Convention; and 

(4) ensure that United States participation in Convention meetings is broadly 

inclusive of representatives of relevant Federal departments and agencies. 

PURPOSE AND SUMMARY

H.R. 2356, the WMD Prevention and Preparedness Act of 2011, 

was introduced by Representatives Bill Pascrell, Jr. (D–NJ) and 

Peter T. King (R–NY) on June 24, 2011. The purpose of H.R. 2356 

is to enhance homeland security by improving efforts to prevent, 

protect against, respond to, and recover from attacks with weapons 

of mass destruction, and for other purposes. 

BACKGROUND AND NEED FOR LEGISLATION

Title 18 of the ‘‘Implementing Recommendations of the 9/11 Commission Act of 2007’’ authorized the establishment of a bipartisan 

commission to study the threat posed by the proliferation of weapons of mass destruction (WMD). Congress directed the independent 

Commission for the Prevention of WMD Proliferation and Terrorism (Commission) to assess current activities related to WMD 

prevention and preparedness. 

The Commission, led by former Senators Bob Graham (Chair) 

and Jim Talent (Vice-Chair), was charged with: Assessing Federal 

activities, initiatives, and programs to prevent WMD proliferation 

and terrorism; and providing a clear and comprehensive strategy 

and concrete recommendations to address the WMD threat. Due to 

time constraints and also to the nature of the threats that emerged 

through their research, the Commission chose to focus its efforts on 

biological and nuclear threats, the two WMD threats that they felt 

had the greatest potential to kill the largest number of people within the United States. 

The Commission submitted a report entitled, ‘‘World at Risk: The 

Report of the Commission on the Prevention of Weapons of Mass 

Destruction Proliferation and Terrorism’’ to the President and the 

Congress in December 2008. The Commission concluded that: Unless the global community acts decisively and urgently, a terrorist 

attack involving WMD will more likely than not occur somewhere 

in the world by the end of 2013; terrorists are more likely to obtain 

and use a biological weapon than a nuclear weapon; and the 

United States government needs to more aggressively limit the proliferation of biological weapons and reduce the prospect of a biological terrorist attack. 

In October 2009, the Commission issued a progress report entitled, ‘‘The Clock is Ticking: A Progress Report on America’s Preparedness to Prevent Weapons of Mass Destruction Proliferation 

and Terrorism’’ to call attention to what the Commission believed 

to be the lack of progress in implementing its previous recommendations. Subsequently, in January 2010, the Commission released a ‘‘Prevention of WMD Proliferation and Terrorism Report 

Card,’’ which assessed the actions taken by the United States to 

address the recommendations made in ‘‘World at Risk.’’ Most recently, in October 2011, the follow-up to the Commission—known 

as The WMD Center—released its ‘‘Bio-response Report Card,’’ 

which detailed key areas still at risk in biopreparedness three 

years after the Commission’s initial recommendations were made. 


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Commissioners Graham and Talent testified before the Full Committee on Homeland Security on April 21, 2010. The former Senators testified to their belief that a WMD terrorist attack will occur 

somewhere in the world by 2013. They reiterated their view that 

the Nation has not done enough to prevent and prepare for a domestic biological attack. They also expressed their concern about 

the fractured state of Congressional jurisdiction over homeland security matters and their desire to see jurisdiction for the Department of Homeland Security consolidated in the Committee on 

Homeland Security in the House of Representatives, and the Committee on Homeland Security and Governmental Affairs in the Senate. 

Enactment of H.R. 2356 is needed to better address the gaps 

identified by the Commission and to better organize efforts by the 

public and private sectors to prevent, protect against, respond to, 

and recover from an attack involving WMD. This legislation implements the Commission’s recommendations by requiring a comprehensive approach to preventing and preparing for biological and 

other WMD attacks. The bill addresses the range of actions necessary to counter the WMD threat as identified through the Committee on Homeland Security’s oversight work and the recommendations of the Commission on the Prevention of WMD Proliferation and Terrorism. The approach is to include all aspects of 

the preparedness framework—prevention, protection, response, and 

recovery—for chemical, biological, radiological, and nuclear (CBRN) 

attacks and incidents. 

HEARINGS

The Committee has convened numerous hearings during the 

110th, 111th, and 112th Conresses that have informed the substance of this and prior legislations. 

110th Congress 

On September 18, 2007, the Committee on Homeland Security 

held a hearing entitled ‘‘Protecting the Protectors: Ensuring the 

Health and Safety of our First Responders in the Wake of Catastrophic Disasters.’’ The Committee received testimony from: Jon 

R. Krohmer, MD, Deputy Chief Medical Officer and Principal Deputy Assistant Secretary, Office of Health Affairs, Department of 

Homeland Security; John Howard, MD, Director, National Institute 

for Occupational Health and Safety, Centers for Disease Control 

and Prevention, Department of Health and Human Services; Ms. 

Cynthia A. Bascetta, Director, Health Care, Government Accountability Office; Philip J. Landrigan, MD, MSc, Professor and Chairman, Department of Community and Preventive Medicine, Mount 

Sinai School of Medicine; Deputy Chief Nicholas Visconti, International Association of Fire Fighters; and Mike D. McDaniel, PhD, 

Secretary, Department of Environmental Quality, State of Louisiana. 

On May 15, 2008, the Subcommittee on Intelligence, Information 

Sharing, and Terrorism Risk Assessment held a hearing entitled 

‘‘The Resilient Homeland: How DHS Intelligence Should Empower 

America to Prepare for, Prevent, and Withstand Terrorist Attacks.’’ 

The Subcommittee received testimony from: Stephen E. Flynn, 

PhD, Jeane J. Kirkpatrick Senior Fellow for National Security 


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Studies, Council on Foreign Relations; Mr. Amos N. Guiora, Professor of Law, University of Utah; and Mr. R.P. Eddy, Ergo Advisors. 

On July 22, 2008, the Subcommittee on Emerging Threats, Cybersecurity, and Science and Technology held a field hearing in 

Providence, Rhode Island entitled, ‘‘Emerging Biological Threats 

and Public Health Preparedness: Getting Beyond Getting Ready.’’ 

The Subcommittee received testimony from: Jeffrey W. Runge, MD, 

Chief Medical Officer and Assistant Secretary for Health Affairs, 

Department of Homeland Security; RADM W. Craig Vanderwagen, 

MD, Assistant Secretary for Preparedness and Response, Department of Health and Human Services; Captain Peter Boynton, Deputy Regional Principal Federal Official for Pandemic Influenza and 

Federal Security Director, Bradley International Airport (Connecticut), Transportation Security Administration, Department of 

Homeland Security; Michael G. Kurilla, MD, PhD, Director, Office 

of Biodefense Research Affairs and Associate Director for Biodefense Product Development, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of 

Health and Human Services; Daniel M. Sosin, MD, MPH, Director, 

Biosurveillance Coordination Unit, and Associate Director for 

Science, Coordination Office for Terrorism Preparedness and Emergency Response, Centers for Disease Control and Prevention, Department of Health and Human Services; David Gifford, MD, MPH, 

Director of Health, Department of Health, State of Rhode Island; 

MG Robert T. Bray, Rhode Island Adjutant General, Commanding 

General, Rhode Island National Guard, Director Rhode Island 

Emergency Management Agency, and Homeland Security Advisor, 

State of Rhode Island; Mr. Thomas J. Kilday, Jr., Homeland Security Program Manager, Rhode Island Emergency Management 

Agency, State of Rhode Island; and Hon. Peter T. Ginaitt, Director, 

Emergency Preparedness, Lifespan Hospital Network. 

111th Congress 

On July 29, 2009, the Committee on Homeland Security held a 

hearing entitled ‘‘Beyond Readiness: An Examination of the Current Status and Future Outlook of the National Response to Pandemic Influenza.’’ The Committee received testimony from: Hon. 

Jane Holl Lute, Deputy Secretary, Department of Homeland Security; Hon. William Corr, Deputy Secretary, Department of Health 

and Human Services; Ms. Bernice Steinhardt, Director, Strategy 

Issues, Government Accountability Office; Ms. Colleen M. Kelley, 

National President, National Treasury Employees Union; Mark B. 

Horton, MD, MSPH, Director, Department of Public Health, State 

of California; Mr. Richard G. Muth, Executive Director, Maryland 

Emergency Management Agency, State Emergency Operations 

Center, State of Maryland; and Thomas A. Farley, MD, MPH, 

Health Commissioner, New York City, State of New York. 

On September 14, 2009, the Subcommittee on Emerging Threats, 

Cybersecurity, and Science and Technology held a field hearing in 

Brooklyn, New York entitled ‘‘Status Report on Federal and Local 

Efforts to Secure Radiological Sources.’’ The Subcommittee received 

testimony from: Mr. Craig Conklin, Director, Sector Specific Agency 

Executive Management Office, Office of Infrastructure Protection, 

Department of Homeland Security; Mr. Kenneth Sheely, Associate 

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tional Nuclear Security Administration, Department of Energy; Mr. 

Robert Lewis, Director, Division of Materials Safety and State 

Agreements, Nuclear Regulatory Commission; Captain Michael 

Riggio, Counterterrorism Division, Police Department, City of New 

York, State of New York; Mr. Gene Miskin, Director, Office of Radiological Health, Department of Health and Mental Hygiene, New 

York City, State of New York; Bonnie Arquilla, DO, Director of Disaster Preparedness, State University of New York Downstate Medical Center; and Mr. Gene Aloise, Director, Natural Resources and 

Environment, Government Accountability Office. 

On October 27, 2009, the Subcommittee on Emerging Threats, 

Cybersecurity, and Science and Technology held a hearing entitled 

‘‘Real-Time Assessment of the Federal Response to Pandemic Influenza.’’ The Subcommittee received testimony from: Alexander 

Garza, MD, Chief Medical Officer and Assistant Secretary for 

Health Affairs, Department of Homeland Security; Nicole Lurie, 

MD, Assistant Secretary for Preparedness and Response, Department of Health and Human Services; Mr. Richard Serino, Deputy 

Administrator, Federal Emergency Management Agency, Department of Homeland Security; and Ms. Marcy Forman, Director, Intellectual Property Rights Coordination Center, Department of 

Homeland Security. 

On April 21, 2010, the Full Committee held a hearing entitled 

‘‘Viewpoints on Homeland Security: A Discussion with the WMD 

Commissioners.’’ The Committee received testimony from former 

Senators Bob Graham and Jim Talent. 

On June 15, 2010, the Subcommittee on Emerging Threats, Cybersecurity, and Science and Technology held a legislative hearing 

on H.R. 5498. The Subcommittee received testimony from Sara 

(Sally) T. Beatrice, PhD, Assistant Commissioner, Public Health 

Laboratory, Department of Health and Mental Hygiene, City of 

New York; Randall S. Murch, PhD, Associate Director, Research 

Program Development, National Capital Region, Virginia Polytechnic Institute and State University; Robert P. Kadlec, MD, Vice 

President, Global Public Sector, PRTM Management Consulting; 

and Julie E. Fischer, PhD, Senior Associate, Global Health Security 

Program, Henry L. Stimson Center. 

112th Congress 

On March 17, 2011, the Subcommittee on Emergency Preparedness, Response, and Communications held a hearing entitled ‘‘Ensuring Effective Preparedness, Response, and Recovery for Events 

Impacting Health Security.’’ The Subcommittee received testimony 

from Dr. Alexander G. Garza, MD, MPH, Assistant Secretary for 

Health Affairs, Chief Medical Officer, Department of Homeland Security. This hearing provided Subcommittee Members with an opportunity to examine the President’s Fiscal Year 2012 budget request for OHA and OHA’s progress in developing its mission to provide for health security, among other purposes. 

On April 13, 2011, the Subcommittee on Emergency Preparedness, Response, and Communications held a hearing entitled, ‘‘Taking Measure of Countermeasures (Part 1): A Review of Government 

and Industry Efforts to Protect the Homeland Through Accelerated 

Research, Development, and Acquisition of Chemical, Biological, 

Radiological, and Nuclear Medical Countermeasures.’’ The Subcommittee received testimony from Ms. Cynthia Bascetta, ManVerDate Mar 15 2010 04:59 Sep 15, 2012 Jkt 019006 PO 00000 Frm 00030 Fmt 6659 Sfmt 6602 E:\HR\OC\HR665P1.XXX HR665P1

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aging Director, Health Care, Government Accountability Office; Dr. 

Segaran P. Pillai, Chief Medical and Science Advisor, Chemical and 

Biological Division, Science and Technology Directorate, Department of Homeland Security; Dr. Richard J. Hatchett, Chief Medical 

Officer and Deputy Director, Strategic Sciences and Management, 

Department of Health and Human Services; Dr. Gerald W. Parker, 

Deputy Assistant to the Secretary of Defense, Chemical and Biological Defense, Department of Defense; Ms. Phyllis Arthur, Senior 

Director, Vaccines, Immunotherapeutics, and Diagnostics Policy, 

Biotechnology Industry Organization; Mr. John M. Clerici, Principal, Tiber Creek Partners LLC; and Dr. Daniel Fagbuyi, Medical 

Director, Disaster Preparedness and Emergency Management, 

Children’s National Medical Center. 

On May 12, 2011, the Subcommittee on Emergency Preparedness, Response, and Communications convened a hearing titled, 

‘‘Taking Measure of Countermeasures (Part 2): A Review of Efforts 

to Protect the Homeland through Distribution and Dispensing of 

CBRN Medical Countermeasures.’’ The Subcommittee received testimony from Dr. Alexander Garza, Assistant Secretary for Health 

Affairs and Chief Medical Officer, Office of Health Affairs, Department of Homeland Security; Rear Admiral Ali Khan, Director, Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention, Department of Health and Human 

Services; Mr. Mike McHargue, Director of Emergency Operations, 

Division of Emergency Medical Operations, Florida Department of 

Health; Mr. David Starr, Director, Countermeasures Response 

Unit, New York City Department of Health and Mental Hygiene; 

Chief Lawrence E. Tan, Emergency Medical Services Division, New 

Castle County, Delaware (testifying on behalf of the Emergency 

Services Sector Coalition on Medical Countermeasures); and Dr. 

Jeffrey Levi, Executive Director, Trust for America’s Health. This 

hearing provided Subcommittee Members with the opportunity to 

examine various distribution and dispensing plans and efforts at 

the Federal, State, local, and private sector levels, including an assessment of the challenges faced in distributing and dispensing 

countermeasures to large segments of the population. 

On June 23, 2011, the Subcommittee on Cybersecurity, Infrastructure Protection, and Security Technologies and the Subcommittee on Emergency Preparedness, Response, and Communications held a joint hearing, prior to introduction, on this legislation. The Subcommittees received testimony from Hon. William J. 

Pascrell, Jr. a Representative in Congress from the 8th District of 

New Jersey; Senator Jim Talent, Vice Chairman, The WMD Center; Dr. Robert P. Kadlec, Former Special Assistant to the President for Biodefense; and Mr. Richard H. Berdnik, Sheriff, Passaic 

County, New Jersey. 

On July 26, 2011, the Subcommittee on Cybersecurity, Infrastructure Protection, and Security Technologies held a hearing entitled, ‘‘The Last Line of Defense: Federal, State, and Local Efforts 

to Prevent Nuclear and Radiological Terrorism Within the United 

States.’’ The hearing examined Federal, State, and local efforts to 

implement the domestic portion of the Global Nuclear Detection 

Architecture (GNDA), with a focus on efforts to build capability in 

the interior of the U.S. including through the Securing the Cities 

program. The Subcommittee received testimony from Mr. Warren 


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M. Stern, Director, Domestic Nuclear Detection Office, Department 

of Homeland Security; Mr. Carl Pavetto, Deputy Associate Administrator, Office of Emergency Operations, National Nuclear Security Administration, Department of Energy; Mr. Richard Daddario, 

Deputy Commissioner for Counterterrorism, New York City Police 

Department; Mr. Mark Perez, Homeland Security Advisor, Florida 

Department of Law Enforcement; and Mr. David C. Maurer, Director, Homeland Security and Justice Issues, Government Accountability Office. 

On April 17, 2012, the Subcommittee on Emergency Preparedness, Response, and Communications held a third hearing titled, 

‘‘Taking Measure of Countermeasures (Part 3): Protecting the Protectors.’’ The Subcommittee received testimony from Dr. James D. 

Polk, Principal Deputy Assistant Secretary, Office of Health Affairs, Department of Homeland Security; Mr. Edward J. Gabriel, 

Principal Deputy Assistant Secretary, Preparedness and Response, 

Department of Health and Human Services; Chief Al H. Gillespie, 

President and Chairman of the Board, International Association of 

Fire Chiefs; Mr. Bruce Lockwood, Second Vice President, USA 

Council, International Association of Emergency Managers; Sheriff 

Chris Nocco, Pasco County Sheriff’s Office, Pasco County, Florida; 

and Mr. Manuel Peralta, Director of Safety and Health, National 

Association of Letter Carriers. This hearing, the third in the series 

on medical countermeasures, provided Subcommittee Members 

with the opportunity to explore plans and strategies to ensure that 

emergency response personnel are protected in the event of such an 

attack, including through voluntary pre-event vaccination. 

The Subcommittee on Emergency Preparedness, Response, and 

Communications and the Subcommittee on Cybersecurity, Infrastructure Protection, and Security Technologies held a joint hearing 

on May 9, 2012 entitled, ‘‘First Responder Technologies: Ensuring 

a Prioritized Approach for Homeland Security Research and Development.’’ The Subcommittees received testimony from Dr. Robert 

Griffin, Director of First Responder Programs, Science and Technology Directorate, Department of Homeland Security; Ms. Mary 

H. Saunders, Director, Standards Coordination Office, National Institute of Standards and Technology; Chief Edward Kilduff, Chief 

of Department, New York City Fire Department, New York City, 

New York; Ms. Annette Doying, Director, Office of Emergency Management, Pasco County, Florida; and Ms. Kiersten Todt Coon, 

President and CEO, Liberty Group Ventures. 

COMMITTEE CONSIDERATION

The Committee met on May 9, 2012, to consider H.R. 2356, and 

ordered the measure to be reported to the House with a favorable 

recommendation, amended, by voice vote. The Committee took the 

following actions: 

The Committee adopted H.R. 2356, as amended, by unanimous 

consent. 

The following amendments were offered: 

An Amendment in the Nature of a Substitute offered by 

MR. KING (#1); was AGREED TO by voice vote. 


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An amendment to the Amendment in the Nature of a Substitute 

offered by MR. CUELLAR (#1A); was AGREED TO, by unanimous 

consent. 

Page 67, line 7, before ‘‘To facilitate’’ insert ‘‘(a) IN GENERAL.—’’. 

Page 67, after line 18, insert a new paragraph entitled ‘‘(b) LESSONS LEARNED FOR

NATIONAL LEVEL EXERCISES.’’ 

An amendment to the Amendment in the Nature of a Substitute 

offered by MR. MCCAUL (#1B); was AGREED TO, by unanimous 

consent. 

Amend section 303 ‘‘Sec. 304. Dual-use Terrorist Risks from Synthetic Biology.’’ 

An amendment to the Amendment in the Nature of a Substitute 

offered by MR. MCCAUL (#1C); was AGREED TO, by unanimous 

consent. 

In section 2102, add at the end a new paragraph entitled ‘‘(e) WRITTEN PROCEDURES.’’ 

An amendment to the Amendment in the Nature of a Substitute 

offered by MS. RICHARDSON (#1D); was AGREED TO, by unanimous consent. 

Page 31, after line 7, insert a new subparagraph ‘‘(iii) be designed to provide accurate, essential, and appropriate information and instructions to children and other 

special needs populations within the population directly affected by an incident;’’ 

An amendment to the Amendment in the Nature of a Substitute 

offered by MS. RICHARDSON (#1E); was AGREED TO, by unanimous consent. 

Page 31, strike ‘‘and’’ after the semicolon at line 21, strike the period at line 24 

and insert ‘‘; and’’, and after line 24 insert the following: 

‘‘(iii) to educational and childcare facilities, including daycare centers, 

grade schools, universities, hospitals, and elderly care facilities. 

Page 83, line 26, before the semicolon insert ‘‘, including to individuals, schools, 

universities, hospitals, and elderly care facilities’’. 

An amendment to the Amendment in the Nature of a Substitute 

offered by MS. RICHARDSON (#1F); was AGREED TO, by unanimous 

consent. 

Page 54, line 24, insert before the semicolon at the end the following: ‘‘, including 

the procurement of home medical kits that are approved pursuant to the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) Or the Public Health Service 

Act (42 U.S.C. 201 et seq.), as applicable’.’’. 

An amendment to the Amendment in the Nature of a Substitute 

offered by MS. HAHN (#1G); was AGREED TO, by unanimous consent. 

Page 85, line 7, after ‘‘outbreaks’’ insert ‘‘including outbreaks associated with the 

avian flu’’. 

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the recorded votes on the motion to report legislation and amendments thereto. 

No recorded votes were requested during consideration of 

H.R. 2356. 


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COMMITTEE OVERSIGHT FINDINGS

Pursuant to clause 3(c)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee has held oversight hearings and 

made findings that are reflected in this report. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

In compliance with clause 3(c)(2) of rule XIII of the Rules of the 

House of Representatives, the Committee finds that H.R. 2356, the 

WMD Prevention and Preparedness Act of 2011, would result in no 

new or increased budget authority, entitlement authority, or tax 

expenditures or revenues. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

The Committee adopts as its own the cost estimate prepared by 

the Director of the Congressional Budget Office pursuant to section 

402 of the Congressional Budget Act of 1974. 

JUNE 7, 2012. 

Hon. PETER T. KING, 

Chairman, Committee on Homeland Security, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 2356, the WMD Prevention and Preparedness Act of 2012. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Mark Grabowicz. 

Sincerely, 

DOUGLAS W. ELMENDORF. 

Enclosure. 

H.R. 2356—WMD Prevention and Preparedness Act of 2012 

Summary: CBO estimates that H.R. 2356 would authorize the appropriation of $394 million over the 2013–2017 period for programs in the Department of Homeland Security (DHS), the Department of Health and Human Services (HHS), and other agencies to 

address the threat of weapons of mass destruction. 

Assuming appropriation of the necessary amounts, CBO esti- mates that implementing H.R. 2356 would cost $342 million over 

the 2013–2017 period. The bill would not affect direct spending or 

revenues; therefore, pay-as-you-go procedures do not apply. 

H.R. 2356 would impose intergovernmental and private-sector 

mandates as defined in the Unfunded Mandates Reform Act 

(UMRA) by requiring public and private laboratories to comply 

with new security standards. Because the number of entities affected, the types of toxins and biologic agents covered, and the nature of security measures required would depend on future regulatory actions, CBO cannot estimate the costs of the mandates or 

whether they would exceed the annual thresholds for intergovernmental or private-sector mandates ($73 million and $146 million in 

2012, respectively, adjusted annually for inflation). 

Estimated cost to the Federal Government: The estimated budgetary impact of H.R. 2356 is shown in the following table. The costs 

of this legislation fall within budget functions 150 (international afVerDate Mar 15 2010 04:59 Sep 15, 2012 Jkt 019006 PO 00000 Frm 00034 Fmt 6659 Sfmt 6602 E:\HR\OC\HR665P1.XXX HR665P1

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fairs), 450 (community and regional development), 550 (health), 

750 (administration of justice), and 800 (general government). 

By fiscal year, in millions of dollars— 

2013 2014 2015 2016 2017 2013– 

2017 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

FEMA Programs: 

Authorization Level .............................................................. 42 42 42 42 0 168 

Estimated Outlays ............................................................... 12 25 42 42 29 150 

HHS Programs: 

Estimated Authorization Level ............................................. 45 40 40 40 40 205 

Estimated Outlays ............................................................... 17 36 39 39 40 171 

Other Programs: 

Estimated Authorization Level ............................................. 7 5 3 3 3 21 

Estimated Outlays ............................................................... 7 5 3 3 3 21 

Total Changes: 

Estimated Authorization Level .................................... 94 87 85 85 43 394 

Estimated Outlays ...................................................... 36 66 84 84 72 342 

Note: FEMA = Federal Emergency Management Agency; HHS = Department of Health and Human Services. 

Basis of estimate: For this estimate, CBO assumes that the bill 

will be enacted in 2012, that the necessary amounts will be provided each year, and that spending will follow historical patterns 

for similar activities. 

H.R. 2356 would authorize the appropriation of $42 million annually over the 2013–2016 period for the Federal Emergency Management Agency (FEMA) in DHS to make grants to state, local, 

and tribal governments to prepare for and respond to acts of terrorism and natural or man-made disasters that result in significant 

loss of life. CBO estimates that implementing this grant program 

would cost $150 million over the 2013–2017 period and an additional $18 million after 2017. 

CBO estimates that implementing H.R. 2356 would require the 

appropriation of $205 million over the 2013–2017 period for activities to be conducted by HHS and its agencies. The bill would direct 

HHS to establish and implement a strategy for dispensing antidotes or other countermeasures to mitigate the effects of a terrorist 

attack. H.R. 2356 also would require HHS to review its vaccination 

and antimicrobial dispensing policy and to make recommendations 

to improve that policy. Based on information from the Centers for 

Disease Control and Prevention and on costs for similar activities, 

CBO estimates that implementing those requirements would cost 

$171 million over the 2013–2017 period. 

H.R. 2356 would require the Secretary of State to establish an 

interagency task force that would evaluate and improve global preparedness for a major biological attack and to report its findings 

to the Congress. The bill also would authorize the National Security Council to advise the President on biodefense matters, including developing a national biodefense plan and analyzing activities 

undertaken by the federal government to combat biological attacks. 

In addition, H.R. 2356 would require DHS to develop security plans 

and assessments and to prepare reports relating to threats from 

weapons of mass destruction. Based on the cost of similar programs, CBO estimates that it would cost $21 million over the 

2013–2017 period to carry out those activities. 

Pay-As-You-Go considerations: None. 


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Intergovernmental and private-sector impact: H.R. 2356 would 

require public and private laboratories to comply with new security 

standards and procedures that are specific to highest-risk biological 

agents and toxins. Those new standards include personnel hiring 

and training practices, physical and cyber security requirements, 

information sharing protocols, and other security standards deemed 

necessary. The duty to comply with the new standards would impose intergovernmental and private-sector mandates as defined in 

UMRA. Because the number of entities affected, the types of toxins 

and biologic agents covered, and the nature of limits and security 

measures required would depend on future regulatory actions, CBO 

cannot estimate the cost of the mandates. Consequently, CBO cannot determine whether the costs would exceed the annual thresholds for intergovernmental or private-sector mandates ($73 million 

and $146 million in 2012, respectively, adjusted annually for inflation). 

Grants and other forms of assistance authorized in the bill would 

benefit agencies of state, local, and tribal governments, including 

public institutions of higher education that prepare for and respond 

to acts of terrorism, natural disasters, and other man-made disasters. 

Estimate prepared by: Federal Costs: Mark Grabowicz (DHS), 

Stephanie Cameron (HHS), Daniel Hoople (FEMA), Sunita D’Monte 

(Department of State); Matthew Pickford (National Security Council); Impact on State, Local, and Tribal Governments: Lisa Ramirez-Branum; Impact on the Private Sector: Michael Levine. 

Estimate approved by: Theresa Gullo, Deputy Assistant Director 

for Budget Analysis. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

Pursuant to clause 3(c)(4) of rule XIII of the Rules of the House 

of Representatives, H.R. 2356 contains the following general performance goals, and objectives, including outcome related goals and 

objectives authorized. 

The purpose of H.R. 2356 is to enhance homeland security by improving efforts to prevent, protect against, respond to, and recover 

from attacks with weapons of mass destruction (WMD), and for 

other purposes. This bill addresses the range of actions necessary 

to counter the WMD threat as identified through the Committee on 

Homeland Security’s oversight work and the recommendations of 

the Commission on the Prevention of WMD Proliferation and Terrorism in its report, ‘‘World at Risk: The Report of the Commission 

on the Prevention of Weapons of Mass Destruction Proliferation 

and Terrorism.’’ The bill addresses all aspects of the preparedness 

framework—prevention, protection, response, and recovery—for 

chemical, biological, radiological, and nuclear (CBRN) attacks and 

incidents. 

The objectives of H.R. 2356 are to: 

Address the recommendations of the Commission for the Prevention of WMD Proliferation and Terrorism as described in its 

report, ‘‘World at Risk’’; 

Provide for a strategic approach to the national biodefense enterprise through high level planning, leadership, and integrated budgeting; 


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Establish a national biosurveillance strategy to increase 

awareness of the biological threat and identify acts of bioterrorism; 

Improve the capabilities of the United States to collect, analyze, and disseminate WMD-related intelligence; 

Integrate national biosecurity and biodefense stakeholders 

into the homeland security intelligence and information sharing process; 

Provide a strong basis for CBRN risk assessments to be used 

in order to improve security while prioritizing resources; 

Ensure that the export enforcement activities of the Federal 

government are coordinated; 

Ensure that prevention goals are met through activities including appropriate information sharing; performance of CBRN 

terrorism risk assessments; coordination of Federal export enforcement; proper communication of threat information to 

state, local, and Tribal authorities and to the public; and promoting individual and community preparedness; 

Ensure that protection goals are met through activities including detection of biological attacks; rapid biological threat 

identification at ports of entry; evaluation of detection technology; and domestic implementation of the Global Nuclear Detection Architecture; 

Ensure that response goals are met through activities including promulgation of guidance for first responders; development 

and dissemination of integrated plume models; establishment 

of a program to assess and validate first responder equipment; 

authorization of appropriate payment for laboratory response 

services; authorization of a bioforensics analysis center; and 

authorization of the Metropolitan Medical Response System 

Program; 

Ensure that recovery goals are met through initiatives including identification of gaps in recovery capabilities; promulgation 

of guidance for recovery; and exercising of recovery activities; 

Strengthen security at laboratories that possess biological 

agents considered material threats to the nation; 

Promote research that will help prevent the misuse of synthetic biology, and promote the promulgation of guidance for 

Federal agencies that conduct research with dual use potential; 

Provide the sense of Congress that coordination of Federal research and development into medical countermeasures requires 

improvement; 

Require the development of a National Medical Countermeasure Dispensing Strategy to improve rapid response capabilities in the aftermath of a CBRN incident, and similarly require a review of pre-event vaccination and antimicrobial dispensing policies; 

Require that surplus vaccines and antimicrobials, and those 

with short shelf lives, be made available on a voluntary basis 

to first responders; 

Require regular review of the list of agents considered material threats to the nation; 

Require improved coordination among Federal agencies on 

background checks for those individuals requesting access to 

work with select agents; 


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Reduce the misuse of life sciences and enhance global biosecurity through increased international collaboration and information sharing; 

Identify and communicate best practices for preparedness 

based on lessons learned from United States domestic efforts 

that may be useful internationally; 

Promote the Biological and Toxin Weapons Convention; and 

Leverage existing systems and frameworks to the greatest extent possible to achieve the above goals; and 

Overall, improve interagency cooperation on addressing 

CBRN risks. 

CONGRESSIONAL EARMARKS, LIMITED TAX BENEFITS, AND LIMITED

TARIFF BENEFITS

In compliance with rule XXI of the Rules of the House of Representatives, this bill, as reported, contains no congressional earmarks, limited tax benefits, or limited tariff benefits as defined in 

clause 9(e), 9(f), or 9(g) of the rule XXI. 

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates prepared by the Director of the Congressional Budget Office 

pursuant to section 423 of the Unfunded Mandates Reform Act. 

PREEMPTION CLARIFICATION

In compliance with section 423 of the Congressional Budget Act 

of 1974, requiring the report of any Committee on a bill or joint 

resolution to include a statement on the extent to which the bill or 

joint resolution in intended to preempt State, local, or Tribal law, 

the Committee finds that H.R. 2356 does not preempt any State, 

local, or Tribal law. 

ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act were created by this legislation. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that the legislation does not relate to the 

terms and conditions of employment or access to public services or 

accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Sec. 1. Short title; table of contents. 

This section provides that the Act may be cited as the ‘‘WMD 

Prevention and Preparedness Act of 2012.’’ 

Sec. 2. Definitions. 

This section defines the following terms: ‘‘appropriate congressional committees’’; ‘‘Intelligence Community’’; and ‘‘national biosecurity and biodefense stakeholders.’’ 


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TITLE I—A NATIONAL BIODEFENSE ENTERPRISE

Sec. 101. Special Assistant for Biodefense. 

Section 101 requires the President to assign a member of the National Security Council to serve as the Special Assistant to the 

President for Biodefense. The Special Assistant shall serve as the 

principal advisor to the President regarding coordination of Federal 

biodefense policy including prevention, protection, response, and recovery from biological attacks or other phenomena that may have 

serious health consequences for the United States, including widescale fatalities or infectious disease outbreaks. In so doing, the Special Assistant shall identify gaps in the existing biodefense posture, 

lead the development of a National Biodefense Plan, National Biosurveillance Strategy, and microbial forensics strategy, oversee 

with the Director of the Office of Management and Budget a crosscutting biodefense budget, and in general conduct oversight of the 

implementation of Federal biodefense activities. 

The Committee is concerned that the President has not designated an individual with sufficient authority and singularity of 

mission for the substantial responsibility of coordinating Federal 

biodefense activities. A position of the kind described existed under 

both President William J. Clinton and President George W. Bush, 

and was eliminated in the current Administration. Although the 

Administration has designated a ‘‘WMD Coordinator’’ as required 

by the ‘‘Implementing Recommendations of the 9/11 Commission 

Act of 2007,’’ (Pub. Law 111–53) this individual has engaged almost 

exclusively in nuclear counterproliferation matters. Without a central point of authority to coordinate the myriad departmental and 

interagency Federal activities related to biodefense, inefficiencies, 

redundancies, and gaps in resource allocation across an estimated 

$6 billion annual enterprise are likely to occur. The Committee intends for this individual to be vested with the necessary authorities 

to ensure a truly strategic Federal approach to biodefense. 

Sec. 102. National Biodefense Plan. 

Section 102 requires the Special Assistant to the President for 

Biodefense to submit to the President a National Biodefense Plan 

that integrates myriad existing plans and addresses identified capability gaps. Specifically, the plan identifies biological risks to the 

nation and capability gaps in mitigating those risks, delineates 

needed defense activities, coordinates existing strategic documents 

and plans, defines intergovernmental roles, and provides planning 

guidance to biodefense and biosecurity stakeholders. 

A central tenet of the WMD Commission’s report was that 

United States policy and strategy have not kept pace with growing 

risks. Other bodies have also criticized Federal efforts at strategic 

planning, such as the National Biodefense Science Board, which 

found weaknesses in the Federal approach to medical countermeasure development. Of course, agency-specific planning efforts 

have not always been sufficient, either; correspondence between 

goals and investments must occur at the agency level for any interagency effort to be completely successful. The Committee believes 

that cross-agency planning should be centralized, should have 

metrics that are assessed regularly, and should be led by an individual endowed with the necessary authority to see to it that budget decisions are appropriate, and take corrective action when they 


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are not. The Committee recognizes that numerous documents are 

considered to be targeted or broad biodefense strategies or implementation plans, including, but not limited to, several Homeland 

Security Presidential Directives; Presidential Policy Directives; the 

‘‘National Strategy for Pandemic Influenza’’ and its implementation 

plan; and, most recently, the ‘‘National Health Security Strategy’’ 

and its implementation plan. Many of these have elements that 

would direct preparedness and response for biological events, but 

the Committee believes that a single implementation plan dedicated to the biodefense enterprise—a National framework that 

would organize and prioritize biodefense investments based on 

risk—is still needed. 

The Committee understands that the scope of such a plan could 

be so extensive as to make it unfeasible to implement in a useful 

way. As such, the Committee intends for the plan to prioritize 

those efforts that will mitigate the variety of biological risks in the 

most meaningful and cost-effective way. This can be done by assessing and then addressing areas of most urgent need in prevention, protection, response, and recovery, including through use of 

Department of Homeland Security risk assessments. It should also 

consider that some critical infrastructure sectors are more vulnerable than others, and the plan should leverage strengths of different agencies for minimizing cross-sector vulnerabilities. The 

Committee also encourages the planners to think innovatively and 

consider alternative approaches to preparedness than have previously been the paradigm, for instance, the narrow planning for a 

given agent that has characterized some previous efforts. The Committee also intends the plan to address food defense. 

Sec. 103. National Biosurveillance Strategy. 

Section 103 requires the Special Assistant to the President for 

Biodefense to examine the current state of biosurveillance and develop and maintain a national strategy for biosurveillance. Importantly, this strategy shall include an implementation plan to: Advance real-time situational awareness; foster information sharing 

among stakeholders; and enhance the capability of the Federal government to rapidly identify, characterize, localize, and track a biological event of National concern by integrating and analyzing 

data. 

The National Academies of Science reported in 2009 that the Department of Homeland Security and the Department of Health and 

Human Services should enhance efforts to develop a national system of situational awareness for biological threats. In 2010, the 

Government Accountability Office (GAO) reported that the Nation 

still lacks an overall strategy to help guide Federal agencies and 

their partners’ efforts to build and maintain an integrated National 

biosurveillance capability. As the GAO points out, the ‘‘National 

Strategy for Countering Biological Threats’’ and the ‘‘National 

Health Security Strategy’’ direct further development of biosurveillance strategies and plans to help support their broader biodefense 

goals. The Committee intends for the National Biosurveillance 

Strategy to build on these proposed goals and frameworks, and to 

focus explicitly on how to meet the challenges associated with 

sourcing good data and with information sharing. The Committee 

is aware that many challenges are associated with the acquisition 

and analysis of biosurveillance data sets, with the sharing of the 


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data between and among different professions, and in dealing with 

relevant classified information. There are also many opportunities, 

however, that may facilitate such a system, such as the expansion 

of use of electronic health records. Such a capability is critical, 

given that biological events often cannot be prevented, but can be 

mitigated through early detection. The Committee encourages the 

drafters to consider aligning goals and activities to those of Presidential Policy Directive 8 (PPD–8) and its follow-ons. 

Inconsistency in the definition and interpretation of ‘‘biosurveillance’’ has complicated challenges associated with implementation 

and coordination of efforts at the National level. The Strategy must 

include a definition of ‘‘biosurveillance’’ so that efforts to meet the 

goals of the Strategy are properly focused. Definitions should be 

standardized with other National biosurveillance efforts. 

Upon Committee filing of this report, the National Security Staff 

released such a strategy. The strategy is consistent with the Committee’s intent to frame the purpose of a Nationally integrated biosurveillance capability, to integrate it with other relevant strategies, and to emphasize the need for leveraging existing activities. 

Important components, however, such as defining goals and milestones, and defining roles and responsibilities, are lacking. The 

Committee is, therefore, anxious to examine the implementation 

plan that is due to follow in 120 days, which will hopefully address 

these and other needed details. Such an implementation plan is 

particularly important in light of the fact that the one Federal effort toward integrating biosurveillance information—the National 

Biosurveillance and Integration System—has not achieved optimal 

performance and the nation remains without this capability. 

Sec. 104. Comprehensive cross-cutting biodefense budget analysis. 

Section 104 requires the Special Assistant to the President for 

Biodefense, in coordination with the Director of the Office of Management and Budget, to transmit to the appropriate Congressional 

committees a comprehensive cross-cutting biodefense budget analysis that delineates and integrates the biodefense expenditure requests for all Departments and agencies involved in Federal biodefense efforts. All agencies that perform biodefense work shall 

submit their proposed budget request to the Special Assistant 30 

days in advance of their formal submission to the Office of Management and Budget. The budget analysis shall provide a detailed 

analysis identifying appropriations, obligational authority, and outlays that contribute to biodefense. The analysis will also include an 

indication of how the Federal activities in the budget support the 

activities outlined in the National Biodefense Plan. 

The Office of Management and Budget neither assesses nor directs all annual Federal biodefense expenditures in a cross-cutting 

manner. In fact, estimates of total Federal dollars spent are derived only from think tank analyses. In the absence of such an integrated approach, funds will not be optimally spent. The Committee intends that the Special Assistant to the President for Biodefense, working with the Director of the Office of Management 

and Budget, will be endowed with sufficient authority to collect the 

necessary information from all relevant Departments and agencies, 

and require modifications to budget submissions as necessary, consistent with the National Biodefense Plan. 


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TITLE II—INTELLIGENCE MATTERS

Sec. 201. National Intelligence Strategy for Countering the Threat 

from Weapons of Mass Destruction. 

Section 201 requires the Director of National Intelligence, in consultation with the Secretary of Homeland Security and other appropriate Federal agencies, to develop and implement a National Intelligence Strategy for Countering the Threat from Weapons of Mass 

Destruction to improve national capabilities to collect, analyze, and 

disseminate intelligence related to WMD. The strategy shall identify and address target capabilities needed for successful WMD intelligence collection; include methods for recruitment, training, and 

retention of individuals with expertise in the collection, analysis, 

and dissemination of intelligence related to different types of 

WMD; and include methods for information sharing and collaboration with non-Federal stakeholders. The strategy shall be accompanied by an implementation plan. 

The Congressionally-mandated Commission on the Prevention of 

WMD Proliferation and Terrorism found insufficiencies in the Intelligence Community’s ability to undertake WMD collection and 

analysis. The Committee recognizes that the Intelligence Community addresses the WMD threat in various parts of the National Intelligence Strategy but believes that the establishment of a targeted national strategy for countering this homeland security 

threat is necessary given that the responses to this emerging 

threat are dissimilar from responses to traditional threats. Accordingly, the Committee intends for the strategy to take these differences into account and to contain goals and objectives that are 

tailored to the unique characteristics of the WMD threat. The Committee believes that individuals with considerable knowledge of 

WMD may reside in the United States government but outside of 

the Intelligence Community. The Committee intends for the Intelligence Community to reach out to these experts and, where appropriate, to ask these experts to assist in the analysis of technical information related to WMD. 

Sec. 202. National Intelligence Strategy for Countering Biological 

Threats. 

Recognizing the unique nature of the biological threat, Section 

202 requires the Director of National Intelligence, in consultation 

with the Secretary of Homeland Security, the Special Assistant to 

the President for Biodefense, and the heads of other agencies to develop and implement a National Intelligence Strategy for Countering Biological Threats. The strategy shall identify and address 

target capabilities needed for successful intelligence collection on 

biological threats; include a plan for establishing a cadre of collectors and analysts in the Intelligence Community; include methods 

for collaboration; and include a plan for ensuring the prioritization 

and sustained commitment of personnel and resources to address 

biological threats. The strategy shall be accompanied by an implementation plan. 

The bioweapons threat must remain among the highest national 

intelligence priorities, according to the WMD Commission. The 

Committee has, therefore, called out an additional strategy for biological threats since it is this threat that the Commission determined to be of the most concern; this strategy may be separate 


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from the strategy outlined in Sec. 201, or an annex to it. The Committee intends for this strategy to build on the National Intelligence Strategy for Countering Biological Threats, as initially produced in 2007 and to authorize the activities already in place regarding the National Intelligence Strategy for Countering Biological Threats. The Committee also intends for the Director of National Intelligence to draw upon knowledge in the National 

Counterproliferation Center, the National Counterterrorism Center 

and other members of the Intelligence Community, as appropriate. 

Sec. 203. State, local, and tribal defined. 

In this title, the term ‘‘State, local, and tribal’’ has the same 

meaning that term has in the ‘‘Homeland Security Act of 2002.’’ 

TITLE III—HOMELAND SECURITY MATTERS

Sec. 301. Weapons of mass destruction prevention and preparedness. 

Amends the Homeland Security Act of 2002 (Pub. Law 107–417) 

by adding at the end the following new title: 

Title XXI—Weapons of Mass Destruction Prevention and 

Preparedness 

SUBTITLE A—PREVENTION

Sec. 2101. Weapons of mass destruction intelligence and information sharing. 

Section 2101 requires the Department of Homeland Security Office of Intelligence and Analysis (I&A) to support homeland-security focused analysis of terrorist actors pertaining to CBRN materials, global biological threats, public health and food, agricultural, 

and veterinary issues. The Department is required to leverage existing and emerging homeland security capabilities, such as fusion 

centers, and share information with State, local, and Tribal partners and other stakeholders. Where appropriate, I&A shall coordinate with other relevant Department components, others in the Intelligence Community, and other Federal, State, local, and Tribal 

authorities, including officials from high-threat areas, and enable 

such entities to provide recommendations on optimal information 

sharing mechanisms. The Secretary shall report annually to the 

appropriate congressional committees on activities to counter the 

threat from WMD conducted by all relevant entities within the Department. 

The Committee is aware that many agencies, including the Department of Homeland Security, are engaged in CBRN intelligence 

and information sharing activities. This provision ensures that the 

Department has adequate and enduring expertise in its intelligence 

division to analyze and disseminate CBRN information, which may 

be highly technical, and provide value within the Intelligence Community. The Committee believes that this unit should work to the 

greatest extent possible with other Department of Homeland Security components (operational and intelligence), headquarters elements, others in the Intelligence Community, and State, local, and 

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WMD activities. State, local, and Tribal participation, in particular, 

should include officials from high threat areas. The effective and 

appropriate sharing of information with State and local partners is 

paramount and remains a Committee priority. The Committee does 

not intend for the activities outlined by this section to duplicate 

those already conducted by the National Counterterrorism Center, 

the Federal Bureau of Investigation, or other members of the Intelligence Community. The Committee believes that strict adherence 

to relevant national intelligence strategies, including those authorized in Sections 201 and 202 of this Act, will ensure clarity of mission for each Federal entity engaged in WMD intelligence activities. 

Sec. 2102. Risk assessments. 

Section 2102 requires the Secretary of Homeland Security, acting 

through the Under Secretary for Science and Technology, and in coordination with other appropriate Department of Homeland Security components and Federal departments and agencies, to produce 

and periodically update a terrorism risk assessment for CBRN 

threats, as well as an integrated risk assessment that assesses all 

of the above threats and ranks them against one another according 

to their relative risk. Each assessment shall include a description 

of the methodology used to conduct it, and the Secretary shall convene an interagency task force of subject matter experts to provide 

recommendations as to the adequacy of the methodologies. Sensitivity analyses shall also be conducted on each assessment, and 

each assessment shall consider the risk from an evolving adversary. The assessments shall be used to inform and guide Department of Homeland Security material threat assessments and determinations; allocation of research and development resources; 

prioritization of medical countermeasure research, development, acquisition, and distribution and other national strategic biodefense 

research; tailored risk assessments and risk mitigation studies; and 

other homeland security activities. In developing the assessments, 

the Secretary shall seek input from national biosecurity and biodefense stakeholders. The assessments shall be shared in classified 

and unclassified formats with Federal, State, local, and Tribal officials with a need for the information. The Secretary shall also establish written procedures for appropriate usage of the assessments. 

The Committee believes that risk assessments are critical for the 

determination of the most appropriate responses for investment of 

finite budget resources. Such assessments must be used to inform 

Departmental priorities, investments, and activities, as well as 

other governmental CBRN activities, such as development of medical countermeasures. They are important for understanding the 

comparative risks of each type of threat, and therefore where to 

prioritize investments. The Committee is aware that the Department undertakes terrorism risk assessments of the type described 

on a two-year cycle, and intends to provide further guidance on 

what those assessments should look like and how they should be 

used. The National Academies of Science has reviewed the Department’s approach to risk assessments, and has provided recommendations to the Department for improvement, specifically 

with respect to the bioterrorism risk assessments and the challenges with using standard techniques to assess that risk. The 


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Committee expects for all of the risk assessments performed under 

this section to continue to improve in their reliability and utility, 

and for recommendations from the established task force to be 

taken seriously. In light of findings from the GAO that the Department’s risk assessments lack written procedures for usage, this section calls for the formalization of such procedures. 

Sec. 2103. National Export Enforcement Coordination. 

Section 2103 establishes that the Department of Homeland Security shall maintain a unit for national export enforcement coordination that is managed by the Secretary and that coordinates the export enforcement activities among the Departments of Homeland 

Security, Agriculture, Commerce, Defense, Energy, Justice, State, 

and the Treasury, the Intelligence Community, and other Federal 

agencies. 

The Committee supports the Administration’s efforts to create 

greater efficiencies in the export control community. The Committee intends to authorize activities underway at the Department 

of Homeland Security to create greater efficiencies in the export 

control community. The Committee recognizes the investigations 

that U.S. Immigration and Customs Enforcement and other Federal law enforcement agencies conduct in this regard, and believes 

that a network for such coordination will increase efficiencies and 

better integrate law enforcement, intelligence, and other related activities for export control. The Committee also intends for these activities to be undertaken with an understanding of the commerce 

and security-related context in which counter-proliferation activities must occur. The Committee does not intend to subsume 

counter-proliferation activities conducted by the Intelligence Community under the Department of Homeland Security. 

Sec. 2104. Communication of threat information. 

Section 2104 requires the Administrator of the Federal Emergency Management Agency (FEMA), in consultation with State, 

local, and Tribal governments and in coordination with other agencies, to develop a communications plan for providing information to 

the public related to preventing, preparing for, responding to, and 

recovering from CBRN attacks. Specifically, the Administrator 

shall develop and disseminate pre-scripted messages and message 

templates to State, local, and Tribal officials so that they can incorporate them into emergency plans, and quickly disseminate critical 

information to the public in anticipation of or in the immediate 

aftermath of an attack. The Administrator shall incorporate such 

message templates into exercises. 

This section also directs the Secretary of Homeland Security, in 

coordination with the Attorney General and heads of appropriate 

Federal agencies, to: ensure that homeland security information 

concerning terrorist threats is disseminated to the general public 

within the United States, as appropriate; and establish a process 

to optimize opportunities for qualified heads of State, local, and 

Tribal governments to obtain appropriate security clearances so 

that they may receive classified threat information when appropriate. This section requires the Secretary of Homeland Security to 

prepare unclassified threat bulletins on CBRN threats. The Secretary shall also provide guidance to State, local, and Tribal authorities on why certain communities are identified as being at 


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heightened risk of exploitation, and on how to communicate terrorism-related threats and risks to the public within their jurisdiction. 

The Committee intends for FEMA to take every opportunity to 

appropriately inform the public about risks, threats, and guidance 

for response to CBRN incidents. Sustained public education campaigns to disseminate as much information as possible in advance 

of a CBRN event are critical. This practice will minimize the 

amount of work and information sharing that must occur post-incident. Pre-scripted messages and templates will allow State, local, 

and Tribal authorities to exercise their own plans in advance for 

sharing information with the public. Unclassified threat bulletins 

will ensure that the public has sufficient knowledge of the nature 

of a CBRN attack that has occurred, without compromising classified information and ongoing investigations. Messaging that provides strong guidance on the responsibility of individuals in the 

early stages of an attack, and the most appropriate actions they 

should take to help themselves and those around them, must be 

part of this planning. The Integrated Public Alert and Warning 

System (IPAWS) should be leveraged in these efforts. The Committee recognizes that FEMA is already undertaking work in this 

area, such as in its improvised nuclear device communications 

planning, and expects this work to continue under the guidance of 

this section, and to leverage the increasing body of literature on effective risk communication. The Committee recommends consultation with non-governmental organizations that can represent the 

needs of the public, including those with disabilities and access and 

functional needs, in the development of appropriate messaging. 

Sec. 2105. Individual and community preparedness for chemical, 

biological, radiological, and nuclear attacks. 

In order to enhance our ability to establish individual and community preparedness Nation-wide for CBRN threats, Section 2105 

requires the Secretary of Homeland Security, acting through the 

Administrator of FEMA, to assist State, local, and Tribal governments in improving and promoting individual and community preparedness and collective response to terrorist attacks by: Developing and disseminating guidance and checklists of recommended 

actions for individual and community prevention and preparedness 

efforts; compiling and disseminating information on best practices; 

providing information and training materials; and conducting individual and community preparedness outreach efforts. 

Preparedness is not solely a Federal responsibility. States, localities, the private sector, and individuals must participate to ensure 

adequate preparation for terrorist events and disasters. Individuals 

and communities must understand in advance those functions that 

they may have to manage for themselves. Section 2105 requires 

FEMA to provide guidance to ensure that all relevant parties have 

the information they need to establish their own measures of preparedness. The Committee is aware that FEMA has undertaken efforts to build a toolkit that includes checklists, good practices, and 

outreach efforts for government at all levels to engage the whole 

community in all-hazards preparedness, including CBRN attacks. 

The Committee also recognizes that FEMA is undertaking activities in association with PPD–8 and the National Preparedness Goal 

that are relevant to the directives in this section. The Committee 


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recommends that these efforts be coordinated and consolidated in 

a way that clearly defines the roles and responsibilities of individuals and communities, in the ‘‘whole of community’’ context, and 

contains all necessary guidelines, checklists, training, and other 

tools for CBRN preparedness and response. 

SUBTITLE B—PROTECTION

Sec. 2121. Detection of biological attacks. 

Section 2121 requires the Secretary of Homeland Security to implement a biological detection capability. The Secretary, through 

this program, shall deploy detectors to areas based on risk to indicate the presence of biological agents, and provide advanced planning tools, concepts of operation, training exercises, and technical 

assistance to jurisdictions hosting the program. This section also 

directs the Secretary to: Enter into memoranda of agreement with 

other agencies to set forth roles and responsibilities; establish criteria to determine whether coverage is sufficient; implement an 

assay equivalency program; and contract with participating laboratories for the provision of laboratory services on a fee-for-service 

basis or other similar basis. This section also requires that a host 

of criteria are met before any new system is procured, including 

performance of cost-benefit analyses and agreement with localities 

on concepts of operations. 

Enhancing the nation’s capabilities for rapid response to biological attacks was one of the top recommendations from the WMD 

Commission. Because detection of a pending biological attack is so 

difficult, rapid post-event detection is key. While an early warning 

detection system is not the sole means to detect a bioterror event, 

the Committee believes that the nation should have an early detection capability so that recognition of sick individuals in the aftermath of the attack is not the only means of detection. The detection 

system called for in this section could currently be met via the 

BioWatch system, although the Committee is well aware that 

BioWatch has not been without management and operational challenges. Accordingly, the Committee notes that the early detection 

mandates of this section could be met through other solutions as 

threats and capabilities evolve over time. To the extent that the 

current BioWatch program is utilized to meet this mandate, information should be provided to participating laboratories on specificity, sensitivity, and limitations of the technology, as well as on 

the public health implications of a positive result. A biodetection 

system should not be seen as a replacement for surveillance via the 

health care system and detection via astute physicians; advanced 

patient-side assays under development will be a critical piece to 

early detection. 

Biodetection cannot be the responsibility of a single department 

or agency, and efforts must be made across government to improve 

capabilities. Furthermore, the Department of Homeland Security 

must work with its Federal partners to ensure consensus on matters such as assay selection and standards. The Committee also 

recognizes that the success of the BioWatch program depends on effective interaction with host State and local public health laboratories. Finally, any efforts to improve detection technologies must 

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quired. The fiscal costs of developing a new system may be too 

great if no or minimal increase in system sensitivity is achieved; 

alternatively, if an increase in capability along with a decrease in 

cost per data point can be accomplished, this might be a good investment. Thorough analysis of the capabilities of the existing system must be undertaken prior to obligation of funds for a new system. The Committee intends for development, procurement, and deployment of any such system to be carried out in alignment with 

the goals and objectives of the National Biodefense Plan outlined 

in Section 102 and the National Biosurveillance Strategy outlined 

in Section 103. 

Sec. 2122. Rapid biological threat detection and identification at 

ports of entry. 

Section 2122 requires the Secretary of Homeland Security, acting 

through the Under Secretary for Science and Technology and in 

consultation with relevant component heads, to assess whether the 

development of technological screening capabilities for biological 

agents, pandemic influenza, and other infectious diseases to support entry and exit screening at ports of entry should be undertaken. If the Under Secretary determines such a capability would 

be of value, the Secretary is directed, to the extent possible, to initiate the development of safe and effective methods to rapidly 

screen incoming persons at ports of entry. 

When the 2009 H1N1 influenza pandemic originated in the 

United Mexican States and crossed over the United States border, 

it surprised U.S. officials who had expected that the next pandemic 

would emanate from Asia. The border remained open and thousands continued to cross every day with no system for border officials to determine who was infected. That experience demonstrated 

that international borders offer very little protection from the 

spread of infectious disease due to the inability to quickly and effectively screen travelers. This section, therefore, requires the Department to determine if a rapid screening capability could be deployed at ports of entry for infectious diseases and could be operationally feasible and useful in controlling the spread of disease or 

the trafficking of biological weapons. If the Department believes 

that such screening tools are necessary, the Committee intends for 

the Science and Technology Directorate to develop these screening 

capabilities. 

Sec. 2123. Evaluating detection technology. 

Section 2123 authorizes the Secretary of Homeland Security, in 

coordination with the Director of the National Institute of Standards and Technology, to establish a program for evaluation of 

chemical and biological detector technologies for end users such as 

first responders. The program would establish metrics for the adoption of voluntary consensus standards; establish a process for voluntary testing and evaluation of such technology; and, with manufacturer permission, make available the results of testing and evaluation. 

The Committee intends for the Science and Technology Directorate to focus resources on this type of testing and evaluation as 

rigorously as possible to determine the value of existing technologies and to inform the purchase of detection technology. This 

program should be coordinated with the activities of the System 


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Assessment and Validation for Emergency Responders (SAVER) 

program, and also with the Stakeholder Panel on Agent Detection 

Assays and other standards work. Test results may be disclosed to 

Federal agencies, State, local and Tribal governments, and the private sector with permission of the manufacturer. 

Sec. 2124. Domestic implementation of the Global Nuclear Detection Architecture. 

Section 2124 requires the Director of the Domestic Nuclear Detection Office (DNDO) to establish and maintain a multi-layered 

system of detection technologies and programs to enhance the Nation’s ability to interdict a radiological or nuclear device in highrisk cities. This section also requires the Director to develop a 

surge capability for radiological and nuclear detection systems that 

can be rapidly deployed in response to actionable intelligence. The 

programs described above shall be integrated into the Global Nuclear Detection Architecture. 

This section authorizes the Securing the Cities (STC) program to 

detect and prevent a radiological or nuclear attack in high-risk 

United States cities. The detonation of an improvised nuclear device or a radiological dispersal device in a metropolitan area of the 

United States would have devastating consequences due to loss of 

life, destruction of property, and economic repercussions that ripple 

across the nation. STC is the only DHS program dedicated specifically to reducing the risk of radiological and nuclear terrorism 

through targeted detection. STC has fostered unprecedented collaboration and coordination among its many Federal, State, and 

local partners. The Committee finds that STC has substantially increased preventive radiological and nuclear detection awareness 

and capabilities in the New York City metropolitan areaarea and 

is an effective strategy for addressing the domestic layer of the 

Global Nuclear Detection Architecture. The Committee commends 

DNDO for its development and oversight of this unified strategy. 

The Committee believes the experience in New York City should be 

used as a template for expanding the program to other high-risk 

cities that participate in the Urban Area Security Initiative. Building on the program’s record of success, DNDO is highly encouraged 

to develop a cost-effective plan for expansion of STC to additional 

cities and encompass a broader range of WMD threats. 

The Director of DNDO is also instructed to focus efforts on coordinating the development of surge capabilities for radiological 

and nuclear detection systems that can be deployed within the 

United States rapidly in response to intelligence or warnings. This 

includes support to State and local entities with equipment, training and exercises. The Committee believes the combination of both 

fixed and agile detection components into a flexible architecture is 

the most cost-effective, risk-based strategy for the domestic prevention of radiological and nuclear terrorism. DNDO is strongly encouraged to address gaps in the detection of shielded highly enriched uranium as it develops and deploys these new surge capabilities. 


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SUBTITLE C—RESPONSE

Sec. 2131. First responder guidance concerning chemical, biological, radiological, and nuclear attacks. 

Section 2131 requires the Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, the 

Secretary of Agriculture, the Administrator of the Environmental 

Protection Agency, the Attorney General, and the heads of other 

Federal departments and agencies, to develop voluntary, risk-based 

guidance for emergency and public health personnel for responding 

to an explosion or release of CBRN material. This guidance shall 

contain components such as protective actions for ensuring the security, health, and safety of emergency response providers and 

their families and household contacts, and best practices for emergency response providers to effectively diagnose, handle, and otherwise manage individuals affected by an incident involving such an 

agent. The Secretary shall enable the first responder and first provider community to submit recommendations for areas for which 

guidance could be developed. 

Stakeholders have advised the Committee that current guidance 

is disparate and can be difficult to follow. The Committee believes 

it is necessary that a resource be developed to serve as a comprehensive emergency response standard, which addresses the full 

range of hazards or concerns currently facing emergency responders. The Committee intends that the Department will standardize 

a process that will involve appropriate individuals from the emergency responder communities to participate in the reviews and provide material that is quickly accessible and easily updated. The 

Committee hopes that the inclusion of the community in the process will result in universal guidance of considerable utility. The 

Committee intends that the Department will review relevant existing Federal, non-Federal, international, academic, and non-governmental materials when developing the guidance. Guidance promulgated under this section should be integrated into curricula for first 

responder training provided by the Center for Domestic Preparedness and other such accredited facilities to enhance WMD capabilities among our nation’s first responders. 

The Committee recognizes the importance of aligning response 

throughout the chain of leadership in the event of a WMD attack 

or incident. The Committee expects the Department to work closely 

with other Executive departments and agencies, such as the Department of Labor, the Department of Health and Human Services, 

and the Environmental Protection Agency, on the development and 

dissemination of this guidance. The Committee recognizes that 

reaching ‘‘perfect’’ standards may be impossible. The Committee expects, however, that the Department will leverage existing standards and integrate those standards using the best available science 

to provide better guidance and a framework that enhances response capability and safety to the greatest extent possible in an 

area of considerable risk. 

Sec. 2132. Integrated plume modeling for collective response. 

Section 2132 requires the Secretary of Homeland Security to develop and disseminate integrated plume models to enable rapid response activities following a CBRN release. The Secretary shall 

identify Federal, State, and local needs regarding plume models; 


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establish mechanisms for dissemination of these models to enable 

appropriate collective response activities; and ensure that guidance 

and training for the use of such models are provided. 

Plume models help first responders predict locations to where a 

CBRN agent might disperse, allowing for forward deployment of resources and the potential to save many lives. The Committee believes plume models must be integrated with protective action 

guidelines and other appropriate information so they present a 

comprehensive picture to guide optimal response to a CBRN event. 

The Committee recognizes the considerable work already underway 

for plume modeling for assisting government at all levels, including 

FEMA’s work with national laboratories and academia to support 

local government planning needs. The Committee also recognizes 

that agencies other than the Department of Homeland Security 

(such as the Department of Energy and the Department of Defense) have produced many plume models for a variety of theoretical and real-world events. The Committee does not intend for 

the Department of Homeland Security to duplicate this work. Instead, the Committee intends for the Department to acquire plume 

models from these agencies, work with them to integrate protective 

action guidelines and other appropriate information, and subsequently use and disseminate them. 

Sec. 2133. Establishment of the system assessment and validation 

for emergencyresponders (SAVER) program. 

Section 2133 directs the Secretary of Homeland Security to assess and validate commercial emergency responder equipment and 

systems (including hand-held detectors for CBRN agents), provide 

results to the emergency response provider community in an operationally useful form, provide information about equipment on the 

departmental authorized equipment list, enable decision-makers 

and responders to better select, procure, use, and maintain emergency responder equipment, and share this information nationally 

with the emergency response provider community. 

This section authorizes ongoing activity within the Science and 

Technology Directorate. The Committee is concerned that some 

equipment and systems that are commercially available for first responders have not been operationally tested, and manufacturer 

claims may provide insufficient information to assure that the 

equipment will perform reliably in the field. The Committee supports the System Assessment and Validation for Emergency Responders (SAVER) program because it objectively validates the reliability of these systems and equipment and provides first responders with information necessary for better purchasing decisions. The 

Committee urges the SAVER program to consult with the Federal 

Bureau of Investigation and other Federal agencies that have conducted evaluations of such equipment and systems for other purposes for their relevant input, and intends that SAVER will undertake coordination with other Federal efforts to develop minimum 

standards of detection. The Committee also intends that the 

SAVER Program be supported by the Stakeholder Panel on Agent 

Detection Assays program. 

Sec. 2134. Payment for laboratory response services. 

Section 2134 authorizes the Secretary of Homeland Security, the 

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tract with State and local public health laboratories that are members of the Laboratory Response Network (LRN) for Biological Terrorism and other laboratories for the provision of laboratory testing 

services on a fee-for-service basis or on a prepayment or other similar basis. The Centers for Disease Control and Prevention (CDC) 

will be informed by the agencies of such contracts before such time 

that the contracts are signed. 

The Committee recognizes the important work of the participating laboratories in the LRN. The Committee also recognizes 

that the vast amount of initial laboratory testing of suspicious powders and other materials is conducted by State and local public 

health member laboratories. Additionally, the Committee understands that at least one Federal agency has made an unsuccessful 

attempt to transfer funds to the Department of Health and Human 

Services for support of LRN laboratories. The Committee intends 

for the provision to allow Federal agencies participating in the 

LRN to be able to contract directly with State and local LRN laboratories to pay for laboratory testing services on a fee-for-service 

or similar basis, without going through other Federal agencies. The 

Committee does not intend for such payment for LRN services to 

supplant or replace other funding that State and local public health 

laboratories receive from other sources, including those from the 

Department of Health and Human Services. The Committee intends for the Federal agencies that utilize the laboratories to ensure that these contracts are standardized and do not cause interference among other contracts. Furthermore, it is the intent of the 

language that requires informing of the CDC of outside contracts 

to allow the CDC to assess whether such contracts would impact 

the LRN laboratory’s primary mission of responding to public 

health emergencies. 

Sec. 2135. Bioforensics capabilities. 

Section 2135 authorizes a bioforensics analysis center in the Department of Homeland Security that provides law enforcement and 

intelligence-related investigations with forensic examination of biothreat agents and related evidence. The center will require that 

other Executive Branch agencies reimburse it for services, rather 

than rely on Congressional appropriations. 

The Committee supports funding a strong bioforensics capability 

that enables law enforcement to investigate and attribute attacks 

and respond appropriately. Such analysis is intended to support 

the executive agencies responsible for preventing, deterring, responding to, attributing and recovering from biological attacks. 

This mandate could be met by the National Bioforensics and Analysis Center (NBFAC). Section 2135 requires that executive agencies pay for the forensic analysis and capability, exclusive of overhead, rather than having the Department bear all of the costs. The 

Committee expects that the implementation of a user fee-based system will cover the costs of running casework and foster greater 

oversight by the agencies that are NFBAC customers. A detailee 

program is also authorized for the purposes of training and information sharing. 

Sec. 2136. Metropolitan Medical Response System Program. 

Section 2136 requires the Secretary of Homeland Security to conduct a Metropolitan Medical Response System Program (MMRS) to 


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assist State and local governments in preparing for and responding 

to public health and mass casualty incidents resulting from acts of 

terrorism, natural disasters, and other man-made disasters. The 

Secretary of Homeland Security is authorized to provide grants 

through the Administrator of FEMA to State, local, and Tribal governments to strengthen medical surge capacity; strengthen mass 

prophylaxis capabilities; enhance detection capabilities; develop 

mass triage plans; support information sharing and collaboration; 

conduct training and exercises; and strengthen decontamination capabilities. Jurisdictions that received funding in Fiscal Year 2009 

are eligible for continued funding. After Fiscal Year 2012, a jurisdiction shall not be eligible unless the Secretary determines that 

the jurisdiction maintains a sufficient measured degree of capability in accordance with outlined performance measures. The provision also requires a review of the program to provide recommendations going forward. For each of fiscal years 2012 through 

2016, $42 million is authorized. Section 301(d) requires a review of 

the program to provide recommendations going forward. 

The Committee believes that MMRS is an important grant program for the first responder community. Authorizing it at appropriate levels will ensure that it remains a stand-alone program 

with dedicated funding, thereby providing localities with the resources they require to meet critical medical preparedness needs. 

Activities for which MMRS provides resources include response 

training, equipment purchases, dispensing of medical countermeasures, and overall coordination for catastrophic incident response. These activities are resource intensive and require continual equipment maintenance, exercises, and other resources. The 

Committee believes that continued support of homeland security 

grant programs is necessary to ensure that State and local governments build and sustain necessary capabilities to prevent, prepare 

for, respond to, and recover from terrorist attacks. 

SUBTITLE D—RECOVERY

Sec. 2141. Identifying and addressing gaps in recovery capabilities. 

Section 2141 requires the Secretary of Homeland Security, acting 

through the Under Secretary for Science and Technology and in coordination with the Administrator of the Environmental Protection 

Agency, to conduct risk assessments to inform prioritization of recovery activities for CBRN incidents. The results of the assessments shall inform Federal efforts to address the capability gaps 

uncovered by each assessment. 

The ability to recover from a CBRN event is as critical as other 

activities, such as response. If we cannot resume commerce and 

provide a safe and secure environment for living, basic standards 

of living grind to a halt. The Committee believes that insufficient 

attention has been paid to recovery. The Committee intends that 

these risk assessments be conducted in coordination with the heads 

of appropriate departments and agencies, such as the Department 

of Health and Human Services and the Environmental Protection 

Agency. The results shall inform recovery research and the development of recovery guidelines by the Environmental Protection 

Agency. 


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Sec. 2142. Recovery from a chemical, biological, radiological, and 

nuclear attack or incident. 

Section 2142 requires the Secretary of Homeland Security, in coordination and consultation with the heads of several agencies, to 

develop and issue guidance for clean-up and restoration of indoor 

and outdoor areas that have been affected by a CBRN attack or incident. The guidance shall clarify Federal roles and responsibilities 

for assisting State, local, and Tribal authorities, and shall include 

risk-based recommendations for matters such as standards for effective decontamination and means for developing health and safety plans to address first responder health risks. In carrying out the 

guidance development, existing guidance shall be inventoried, and 

the public shall be invited to submit recommendations. The guidance should be prioritized based on the risk assessments performed 

pursuant to section 2141. 

The bill authorizes this existing activity and adds additional requirements to address clean-up and restoration of internal areas, 

such as subways; produce a decision framework for local officials to 

determine how much of an organism growing in specimens taken 

from places that have been cleaned is acceptable; establish effective 

clean-up standards; and establish standards for safe occupancy of 

affected sites. The guidance should be straightforward and sufficiently detailed to help local officials restore their communities and 

ensure that affected areas are appropriately sampled, assessed, 

characterized, and cleaned. The guidance developed under this section should be consistent with existing and planned efforts in other 

Federal departments and agencies, such as decontamination and 

disposal requirements being developed by the Department of Agriculture, and interagency work on the National Disaster Recovery 

Framework. Important kinds of technologies that would aid in recovery efforts, such as those for rapid and effective decontamination, should be considered for FEMA’s Authorized Equipment List 

and cross-referenced in the guidance. The Committee recognizes 

that the Department of Homeland Security is not the sole Federal 

authority in recovery, but views it as the best-suited agency to coordinate the efforts of many agencies in developing much needed 

guidance. The Department should, through this process, help to 

clarify roles and responsibilities among Federal departments and 

agencies, as well as State responsibilities. The guidance should be 

consistent with existing and planned efforts. 

Sec. 2143. Exercises. 

Section 2143 requires the Secretary of Homeland Security to develop exercises in consultation with State, local, and Tribal authorities to facilitate recovery from a CBRN attack or incident. The Secretary shall provide, to the maximum extent practicable, lessons 

learned reports to those governments and other entities that participate in the exercises. The goal of this section is to ensure that 

the guidance developed and promulgated under Section 2142 is sufficiently exercised by State and local stakeholders. Exercises may 

be conducted in coordination with the National Exercise Program. 

Sec. 301(c) Conforming amendment. 

Section 301(c) repeals Section 316 of the Homeland Security Act 

of 2002, which established within the Department of Homeland Security a National Biosurveillance and Integration Center (NBIC). 


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Section 301 instead requires the Special Assistant to the President 

for Biodefense to publish a National Biosurveillance Strategy, 

which shall include a plan for enhancing the capability of the Federal government to rapidly identify, characterize, localize, and 

track a biological event of National concern. 

The Implementing Recommendations of the 9/11 Commission Act 

of 2007 (Pub. Law 107–53) required the Secretary of Homeland Security to establish and operate the NBIC to rapidly identify and 

track a biological event of national concern. While a variety of systems exist at the Federal, State, and local levels to retrieve some 

of this information, none actually integrates all of the data from all 

sectors—human, animal, plant, food, and the environment. This 

lack of integration has prevented the Federal government from 

quickly discovering an agent that might hit two sectors at once, or 

that is detected in two states which use different databases. 

Unfortunately, the Department has been unable to achieve its 

mandate. While reasons for this shortcoming have included technological difficulties and poor management, the Committee believes 

that the most important failing has been refusal by other agencies 

to share their data in the absence of a perceived incentive to do so. 

Lacking sufficient data sharing, the approximate $7 million annual 

cost of the program is wasted taxpayer dollars. The Committee recognizes that the National Security Staff are currently working on 

a new strategy for biosurveillance, but is concerned at its significant delay. The Committee looks forward to receiving this plan, 

and hopes that it harnesses the authority of the President to require the dozen agencies with this kind of data to share the needed 

information. Although the Department of Homeland Security must 

play a coordinating role, it has not succeeded in being the prime 

integrator, and a new approach is necessary. 

Sec. 302. Enhancing laboratory biosecurity. 

Section 302 requires the President to establish a permanent advisory panel, to be known as the Federal Experts Security Advisory 

Panel (FESAP), to make recommendations on biological agent and 

toxin security. The panel is comprised of voting members from 

more than a dozen agencies, and is co-chaired by a representative 

from the Department of Agriculture, the Department of Health and 

Human Services, and the Department of Homeland Security. A 

member of the laboratory community shall also retain a seat as a 

nonvoting member. The panel shall deliver recommendations on 

the highest risk biological agents and toxins that the panel deems 

to present the greatest risk of deliberate misuse; the development 

of a set of minimum risk-based laboratory security performance 

standards; establishment of standards to ensure reliability of personnel with access to the highest risk pathogens; and establishment of physical, cybersecurity, and other necessary security standards. The Secretaries of Agriculture and Health and Human Services shall issue proposed and final rules, as appropriate, based on 

the panel recommendations. This section further requires that Federal oversight over biological laboratories be coordinated, including 

with respect to inspections. Finally, this section requires sharing, 

as appropriate, of information with State, local, and Tribal authorities pertaining to laboratories possessing the highest risk agents. 

The Committee acknowledges the work of the FESAP, which was 

initiated after calls from the Congress and the WMD Commission 


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for closer attention to laboratory biosecurity. This section codifies 

the FESAP and ensures that the Department of Homeland Security 

plays a major role in the panel’s decision-making processes. The 

Secretary of Homeland Security is designated as one of three recipients of the FESAP recommendations to ensure full situational 

awareness. The establishment of personnel reliability standards 

outlined should include a thorough evaluation of existing vetting 

practices, should be approached from a cost-benefit perspective, 

and should not impose processes that would impose unsupportable 

burdens at the local or laboratory level. The Committee intends 

that the proposed rules will include guidance and tools to help laboratories with implementation. Information sharing activities, particularly with State, local, and Tribal partners, are proscribed because the Committee believes that it is important for these authorities to participate fully in the homeland security mission, and that 

in order to do so, these authorities must be empowered with knowledge. 

Sec. 303. Definitions. 

Section 303 amends the Homeland Security Act of 2002 to include definitions of the terms ‘‘Intelligence Community’’ and ‘‘national biosecurity and biodefense stakeholders.’’ 

Sec. 304. Dual-use terrorist risks from synthetic biology. 

Section 304 expresses the sense of Congress that the field of synthetic biology has the potential to facilitate enormous gains in fundamental discovery, but that its inherent dual-use risks must be 

managed. Not less frequently than once every two years, the Secretary of Homeland Security, acting through the Under Secretary 

of Science and Technology, is required to undertake a risk assessment of the dual-use and other risks associated with synthetic biology. The Secretary of Homeland Security is also required to promulgate guidance to other departments and agencies on best practices for assuring compliance with laws and treaties that govern 

biodefense research. This section also authorizes the Under Secretary for Science and Technology to conduct research into ways to 

mitigate the dual-use threat. 

The Committee intends for the Department of Homeland Security to ascertain whether companies that produce and sell synthesized DNA have the ability to support legitimate researchers 

while screening out and preventing bad actors from obtaining these 

materials. Because the field progresses so rapidly, the provision requires regular assessment of the risks to provide policymakers opportunities for decision making into ways to mitigate the risks and 

prioritize budgets appropriately. Understanding that it is challenging to undertake a quantitative risk assessment of synthetic biology, the assessment should at least attempt to utilize well-established methodologies wherein risk is considered as a function of 

threat, vulnerability, and consequences. With respect to promulgation of guidance by the Department of Homeland Security, the Department has a robust compliance division for this purpose, and adherence by other agencies to similar procedures could prevent unintentional breaches of statute, international agreement, or sensitive 

information. 


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Sec. 305. Dissemination of information analyzed by the Department to State, local, Tribal, and private entities with responsibilities relating to homeland security. 

Section 305 expands the list of entities in section 201(d)(8) of the 

Homeland Security Act of 2002 to which the Department disseminates information to include State, local, Tribal, and private sector 

entities with homeland security responsibilities, and as appropriate, to the public, in order to assist in preventing, deterring, or 

responding to acts of terrorism against the United States. Specifically, this provision adds Tribal entities and the public to the existing provision, recognizing that they are important stakeholders and 

partners in these efforts. 

TITLE IV—PUBLIC HEALTH MATTERS

Sec. 401. Sense of Congress regarding Federal coordination on 

medical countermeasures. 

Section 401 expresses the sense of Congress that coordination 

among Federal agencies involved in research, development, and acquisition of medical countermeasures requires improvement, and 

that aggressive action should be taken by the Department of 

Health and Human Services, the Department of Homeland Security, and the Department of Defense to foster improved coordination of such activities, including adoption of an interagency agreement that sets forth relative areas of responsibility. 

The development of medical countermeasures to prevent and 

treat the effects of CBRN agents has progressed significantly since 

the anthrax attacks of 2001. The Committee notes, however, that 

the Federal enterprise to develop such countermeasures is still maturing, and improved interagency collaboration is necessary. The 

Committee, through its oversight work, has observed a need to set 

forth improved agreements among the departments and agencies 

outlined regarding which entities should be undertaking what activities, consistent with existing statutory authorities. These agreements must occur among the departments outlined above, and also 

within the several agencies of the Department of Health and 

Human Services engaged in such work, including the National Institutes of Health, the Biomedical Advanced Research and Development Authority, and the CDC. Some areas have been orphans—for 

instance, only just recently has the Department of Homeland Security undertaken a pilot to examine prospects for a voluntary anthrax vaccination program for first responders, a notion that languished for years without any one agency taking responsibility for 

it. On the other hand, the lines between basic and advanced research are sometimes blurred, leading to the potential for duplicative and/or uncoordinated research initiatives. 

Sec. 402. National Medical Countermeasure Dispensing Strategy. 

Section 402 requires the Secretary of Health and Human Services, in coordination with the Secretary of Homeland Security, the 

Secretary of Agriculture, and the heads of other appropriate Federal agencies, to develop and implement a National Medical Countermeasure Dispensing Strategy to enhance preparedness and collective response to an attack on humans or animals with a CBRN 

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pensing medical countermeasures; post-incident requirements for 

emergency use authorizations; the inclusion of locally held caches 

in such authorizations; and the distribution of home medical kits 

for personal stockpiling within 30 days of an attack. The Secretary 

shall coordinate the strategy with key stakeholders, including 

FEMA, and shall provide the strategy to appropriate congressional 

committees within one year of the date of enactment of the Act. 

The WMD Commission’s initial report found the nation’s capability to respond rapidly to a biological attack and thereby prevent 

the infliction of mass casualties to be lacking, and subsequent report cards have found the same. Although capabilities have improved considerably since the anthrax attacks of 2001, the Committee remains concerned that a mass event would still overwhelm 

current capabilities in most places. The Committee recognizes that 

the Department of Health and Human Services has addressed medical countermeasures dispensing to some extent in the National 

Health Security Strategy, and intends for the Department to give 

enhanced focus to developing a strategy for dispensing medical 

countermeasures. That detailed strategy should include an implementation plan and be adaptable to the needs of local jurisdictions. 

In coordinating with State, local, and Tribal authorities, the private sector, and non-governmental organizations, the Secretary is 

particularly encouraged to seek input from State and local public 

health officials and from the first responder community. The strategy should provide a connection between its recommendations for 

State and local governments and FEMA concepts of operations. 

Sec. 403. National pre-event vaccination and antimicrobial dispensing policy review. 

Section 403 requires the Secretary of Health and Human Services, in coordination with the Secretary of Homeland Security and 

the Secretary of Agriculture, to review the adequacy of domestic 

vaccination and antimicrobial dispensing policy, guidance, and information provided to the public in light of known terrorist risks 

of biological attacks or events with significant health consequences 

to the United States. Considerations for the review include such 

matters as the applicability of shelf life extension programs to locally held stockpiles, provision of expiring products to international 

organizations or foreign partners, the implications for public health 

of pre-event vaccination and antimicrobial dispensing to livestock, 

and ways to increase coordination between the Strategic National 

Stockpile and the National Veterinary Stockpile. The Department 

of Homeland Security terrorism risk assessments and material 

threat determinations, as well as emerging intelligence, should inform the review. The Secretary shall report to the appropriate congressional committees within one year of enactment with the review and with recommendations. 

The Committee notes that current vaccination policy appropriately varies according to threat and risk from specific agents, 

and does not require that vaccines for potential bioterrorism agents 

be provided in advance of the terrorist use of biological agents. The 

Committee believes that vaccination policy should align with material threat determinations, and reviews should be undertaken periodically to determine which, if any, countermeasures in the national stockpile should be made available for pre-event dispensing. 

The Committee is aware that the Public Health Emergency MedVerDate Mar 15 2010 04:59 Sep 15, 2012 Jkt 019006 PO 00000 Frm 00058 Fmt 6659 Sfmt 6602 E:\HR\OC\HR665P1.XXX HR665P1

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ical Countermeasures Enterprise develops utilization policies for 

countermeasures in the Strategic National Stockpile, and the Committee believes that pre-event usage should be part of these discussions. In carrying out this section, the designated departments 

should take into consideration the views of public health, public 

safety, and homeland security experts. The Committee also intends 

for this examination to specifically address (in addition to other 

issues deemed important by the Secretaries) voluntary immunization of first responders, further pre-distribution of antimicrobials to 

the public or a subset of the public, and sending expired vaccine 

and antimicrobials from the national stockpile to other countries 

that could make immediate use of these expiring medicines. 

Sec. 404. Management of short shelf life vaccine and antimicrobial 

stockpiles. 

Section 404 requires the Secretary of Health and Human Services to make available on a voluntary basis surplus vaccines and 

antimicrobials, and vaccines and antimicrobials with short shelf 

lives, from the Strategic National Stockpile to State, local, and 

Tribal first responders. 

The Committee is aware of and supports recent work undertaken 

by the Department of Homeland Security to establish a pilot program to provide otherwise-expiring anthrax vaccine from the national stockpile to first responders. The approach, however, appears 

to be ad hoc. While this section is non-specific as to which countermeasures should be provided, it is the intent of the Committee that 

the Secretary of Health and Human Services engage in a thorough 

determination of which of the countermeasures maintained in the 

stockpile warrant voluntary provision to first responders, and for 

which such provision would be feasible. 

Sec. 405. Material threat determinations reviews. 

Section 405 amends the Public Health Service Act (42 U.S.C.) to 

require review of existing material threat determinations to determine whether these agents continue to present a material threat 

against the United States population sufficient to affect national 

security and homeland security. 

Recognizing the evolving nature of CBRN threats, advances in 

technology, and changing priorities, this section requires the Secretary of Homeland Security, in consultation with the Secretary of 

Health and Human Services and the heads of other appropriate 

Federal departments and agencies, to review and reassess existing 

material threat determinations and decide whether the agents addressed continue to present material threats against the United 

States population. The Committee recognizes that some agents 

pose material threats to the Nation; it acknowledges, however, the 

possibility that these agents may not always pose material threats 

or the same level of threat over time. The Committee intends for 

the list of material threat agents to be composed of agents that 

present current material threats to the nation. The Committee also 

intends for agents to be removed from this list when they no longer 

pose such a material threats. Additionally, the Committee intends 

for these decisions to be made in consideration of availability of 

medical and other countermeasures, new science and technologies, 

immunization rates, and other relevant factors. 


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Sec. 406. Background checks. 

Section 406 amends the ‘‘Public Health Service Act’’ to require 

the Attorney General to coordinate with the Secretary of Homeland 

Security, the Secretary of Defense, and the Secretary of State to determine if these departments possess any information relevant to 

the identification of individuals who should not be given access to 

select agents because they are reasonably suspected of involvement 

with an organization that engages in domestic or international terrorism or with any other organization that engages in domestic or 

international terrorism or crimes of violence. 

The Committee intends for Federal agencies to share information 

on individuals that should not be provided access to Select Agents, 

in order to prevent duplication of background investigations and 

the inappropriate accessing of Select Agents. The Committee intends for all previous legislation addressing background investigations, sole use considerations, etc., to remain in place. 

Sec. 407. State, local, and tribal defined. 

In this title, the term ‘‘State, local, and tribal’’ has the same 

meaning that term has in the ‘‘Homeland Security Act of 2002.’’ 

TITLE V—FOREIGN RELATIONS MATTERS

Sec. 501. International engagement to enhance biodefense and laboratory biosecurity. 

Section 501 requires the Secretary of State, in consultation with 

the Special Assistant to the President for Biodefense and the heads 

of appropriate Federal agencies, to comprehensively address biosecurity in the international arena. Issues to be addressed include 

criminalizing the use of biological weapons or acts of bioterrorism, 

prevention of bioterrorism and the misuse use of life sciences, supporting efforts to enhance biosecurity and biosafety, and information sharing. 

The Committee recognizes that in order to achieve true security, 

a culture of security awareness must be engendered in the life 

sciences, not just domestically but also internationally. The Committee intends that the work required under this section build 

upon engagement activities being undertaken by the Department of 

State. 

Sec. 502. International collaboration and information sharing relating to biosecurity. 

Section 502 directs the Secretary of State, in consultation with 

the Secretary of Homeland Security, the Secretary of Agriculture, 

the Secretary of Health and Human Services, and the heads of 

other agencies, to support efforts in other countries to share information regarding biological attacks and events with significant 

health consequences through United Nations organizations; to advance awareness of the global availability of life science information and its potential dual use risk; and to promote the development of information sharing mechanisms. 

Information sharing, both in terms of intelligence of ongoing 

events and in pre-event preparedness and education, is critical domestically and internationally. Much as these themes have been 

addressed in the domestic sections of this Act, the Committee inVerDate Mar 15 2010 04:59 Sep 15, 2012 Jkt 019006 PO 00000 Frm 00060 Fmt 6659 Sfmt 6602 E:\HR\OC\HR665P1.XXX HR665P1

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tends an interagency approach to fostering these same goals overseas. 

Sec. 503. Interagency task force on best practices for global biopreparedness. 

Section 503 requires the Secretary of State to convene an interagency taskforce to examine the State of global preparedness for a 

major biological attack or event and identify best practices for preparedness based on lessons learned from domestic efforts that may 

be useful or applicable internationally. The task force shall include 

representatives from the Department of Homeland Security, the 

Department of Health and Human Services, the Department of Agriculture, the Department of Defense, the Department of Justice, 

the Department of State, the Director of National Intelligence, 

other appropriate Federal departments and agencies, and other appropriate national biosecurity and biodefense stakeholders. 

The Committee recognizes that the United States is ahead of 

many nations with respect to efforts to prevent, protect against, respond to, and recover from CBRN attacks. The Committee also recognizes that other countries may benefit from United States’ lessons learned, best practices, and other information as they work to 

undertake these activities. The Committee intends for the Federal 

government to gather and communicate this information to other 

countries, as appropriate, and by building upon existing frameworks and fora in which the Department of State participates, 

without compromising homeland and national security. 

Sec. 504. Biological and Toxin Weapons Convention. 

Section 504 requires the Secretary of State to promote the Biological and Toxin Weapons Convention by promoting transparency, 

pursuing compliance diplomatically, promoting universal membership, developing an action plan for increasing international adherence, and ensuring United States participation in meetings is 

broadly inclusive of representatives from relevant Federal agencies. 

The Biological and Toxin Weapons Convention, while imperfect 

in large part due to verification challenges, is one of the best tools 

at the disposal of the international community to limit the development, production, and acquisition of biological and toxin weapons. 

While the origin of the threat of biological weapons development 

has largely shifted since the Convention’s inception from state actors toward non-state actors, the Convention is still relevant. The 

Committee recognizes that the Department of State has been working to promote adherence to the Convention, and intends for the 

leadership role of the Department of State to be maintained and 

strengthened in the parameters outlined, and particularly to ensure that the expertise of the many Federal agencies that work in 

the biodefense space is integrated into the approach. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 

existing law in which no change is proposed is shown in roman): 


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HOMELAND SECURITY ACT OF 2002 

SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

(a) * * * 

(b) TABLE OF CONTENTS.—The table of contents for this Act is as 

follows: 

* * * * * * * 

TITLE III—SCIENCE AND TECHNOLOGY IN SUPPORT OF HOMELAND 

SECURITY 

* * * * * * * 

øSec. 316. National Biosurveillance Integration Center.¿ 

* * * * * * * 

TITLE XXI—WEAPONS OF MASS DESTRUCTION PREVENTION AND 

PREPAREDNESS 

SUBTITLE A—PREVENTION

Sec. 2101. Weapons of mass destruction intelligence and information sharing. 

Sec. 2102. Risk assessments. 

Sec. 2103. National Export Enforcement Coordination. 

Sec. 2104. Communication of threat information. 

Sec. 2105. Individual and community preparedness for chemical, biological, radiological, and nuclear attacks. 

SUBTITLE B—PROTECTION

Sec. 2121. Detection of biological attacks. 

Sec. 2122. Rapid biological threat detection and identification at ports of entry. 

Sec. 2123. Evaluating detection technology. 

Sec. 2124. Domestic implementation of the Global Nuclear Detection Architecture. 

SUBTITLE C—RESPONSE

Sec. 2131. First responder guidance concerning chemical, biological, radiological, 

and nuclear attacks. 

Sec. 2132. Integrated plume modeling for collective response. 

Sec. 2133. Establishment of the system assessment and validation for emergency responders (SAVER) program. 

Sec. 2134. Payment for laboratory response services. 

Sec. 2135. Bioforensics capabilities. 

Sec. 2136. Metropolitan Medical Response System Program. 

SUBTITLE D—RECOVERY

Sec. 2141. Identifying and addressing gaps in recovery capabilities. 

Sec. 2142. Recovery from a chemical, biological, radiological, and nuclear attack or 

incident. 

Sec. 2143. Exercises. 

SEC. 2. DEFINITIONS. 

In this Act, the following definitions apply: 

(1) * * * 

* * * * * * * 

(19) The term ‘‘Intelligence Community’’ has the meaning 

given that term in section 3(4) of the National Security Act of 

1947 (50 U.S.C. 401a(4)). 

(20) The term ‘‘national biosecurity and biodefense stakeholders’’ means officials from the Federal, State, local, and tribal authorities and individuals from the private sector who are 

involved in efforts to prevent, protect against, respond to, and 

recover from a biological attack or other biological incidents 

that may have serious health or economic consequences for the 


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United States, including wide-scale fatalities or infectious disease outbreaks. 

* * * * * * * 

TITLE II—INFORMATION ANALYSIS AND 

INFRASTRUCTURE PROTECTION 

Subtitle A—Information and Analysis and 

Infrastructure Protection; Access to Information 

SEC. 201. INFORMATION AND ANALYSIS AND INFRASTRUCTURE PROTECTION. 

(a) * * * 

* * * * * * * 

(d) RESPONSIBILITIES OF SECRETARY RELATING TO INTELLIGENCE

AND ANALYSIS AND INFRASTRUCTURE PROTECTION.—The responsibilities of the Secretary relating to intelligence and analysis and 

infrastructure protection shall be as follows: 

(1) * * * 

* * * * * * * 

(8) To disseminate, as appropriate, information analyzed by 

the Department within the Department, to other agencies of 

the Federal Government with responsibilities relating to homeland security, øand to agencies of State and local governments 

and private sector entities with such responsibilities in order 

to assist in the deterrence, prevention, preemption of, or response to, terrorist attacks against the United States.¿ to 

State, local, tribal, and private entities with such responsibilities, and, as appropriate, to the public, in order to assist in 

preventing, deterring, or responding to acts of terrorism against 

the United States. 

* * * * * * * 

TITLE III—SCIENCE AND TECHNOLOGY 

IN SUPPORT OF HOMELAND SECURITY 

* * * * * * * 

øSEC. 316. NATIONAL BIOSURVEILLANCE INTEGRATION CENTER. 

ø(a) ESTABLISHMENT.—The Secretary shall establish, operate, 

and maintain a National Biosurveillance Integration Center (referred to in this section as the ‘‘NBIC’’), which shall be headed by 

a Directing Officer, under an office or directorate of the Department that is in existence as of the date of the enactment of this 

section. 

ø(b) PRIMARY MISSION.—The primary mission of the NBIC is to— 

ø(1) enhance the capability of the Federal Government to— 

ø(A) rapidly identify, characterize, localize, and track a 

biological event of national concern by integrating and 


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analyzing data relating to human health, animal, plant, 

food, and environmental monitoring systems (both national 

and international); and 

ø(B) disseminate alerts and other information to Member Agencies and, in coordination with (and where possible 

through) Member Agencies, to agencies of State, local, and 

tribal governments, as appropriate, to enhance the ability 

of such agencies to respond to a biological event of national 

concern; and 

ø(2) oversee development and operation of the National Biosurveillance Integration System. 

ø(c) REQUIREMENTS.—The NBIC shall detect, as early as possible, 

a biological event of national concern that presents a risk to the 

United States or the infrastructure or key assets of the United 

States, including by— 

ø(1) consolidating data from all relevant surveillance systems maintained by Member Agencies to detect biological 

events of national concern across human, animal, and plant 

species; 

ø(2) seeking private sources of surveillance, both foreign and 

domestic, when such sources would enhance coverage of critical 

surveillance gaps; 

ø(3) using an information technology system that uses the 

best available statistical and other analytical tools to identify 

and characterize biological events of national concern in as 

close to real-time as is practicable; 

ø(4) providing the infrastructure for such integration, including information technology systems and space, and support for 

personnel from Member Agencies with sufficient expertise to 

enable analysis and interpretation of data; 

ø(5) working with Member Agencies to create information 

technology systems that use the minimum amount of patient 

data necessary and consider patient confidentiality and privacy 

issues at all stages of development and apprise the Privacy Officer of such efforts; and 

ø(6) alerting Member Agencies and, in coordination with 

(and where possible through) Member Agencies, public health 

agencies of State, local, and tribal governments regarding any 

incident that could develop into a biological event of national 

concern. 

ø(d) RESPONSIBILITIES OF THE DIRECTING OFFICER OF THE

NBIC.— 

ø(1) IN GENERAL.—The Directing Officer of the NBIC shall— 

ø(A) on an ongoing basis, monitor the availability and 

appropriateness of surveillance systems used by the NBIC 

and those systems that could enhance biological situational awareness or the overall performance of the NBIC; 

ø(B) on an ongoing basis, review and seek to improve the 

statistical and other analytical methods used by the NBIC; 

ø(C) receive and consider other relevant homeland security information, as appropriate; and 

ø(D) provide technical assistance, as appropriate, to all 

Federal, regional, State, local, and tribal government entities and private sector entities that contribute data relevant to the operation of the NBIC. 


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ø(2) ASSESSMENTS.—The Directing Officer of the NBIC 

shall— 

ø(A) on an ongoing basis, evaluate available data for evidence of a biological event of national concern; and 

ø(B) integrate homeland security information with NBIC 

data to provide overall situational awareness and determine whether a biological event of national concern has occurred. 

ø(3) INFORMATION SHARING.— ø(A) IN GENERAL.—The Directing Officer of the NBIC 

shall— 

ø(i) establish a method of real-time communication 

with the National Operations Center; 

ø(ii) in the event that a biological event of national 

concern is detected, notify the Secretary and disseminate results of NBIC assessments relating to that biological event of national concern to appropriate Federal response entities and, in coordination with relevant Member Agencies, regional, State, local, and 

tribal governmental response entities in a timely manner; 

ø(iii) provide any report on NBIC assessments to 

Member Agencies and, in coordination with relevant 

Member Agencies, any affected regional, State, local, 

or tribal government, and any private sector entity 

considered appropriate that may enhance the mission 

of such Member Agencies, governments, or entities or 

the ability of the Nation to respond to biological events 

of national concern; and 

ø(iv) share NBIC incident or situational awareness 

reports, and other relevant information, consistent 

with the information sharing environment established 

under section 1016 of the Intelligence Reform and Terrorism Prevention Act of 2004 (6 U.S.C. 485) and any 

policies, guidelines, procedures, instructions, or standards established under that section. 

ø(B) CONSULTATION.—The Directing Officer of the NBIC 

shall implement the activities described in subparagraph 

(A) consistent with the policies, guidelines, procedures, instructions, or standards established under section 1016 of 

the Intelligence Reform and Terrorism Prevention Act of 

2004 (6 U.S.C. 485) and in consultation with the Director 

of National Intelligence, the Under Secretary for Intelligence and Analysis, and other offices or agencies of the 

Federal Government, as appropriate. 

ø(e) RESPONSIBILITIES OF THE NBIC MEMBER AGENCIES.— 

ø(1) IN GENERAL.—Each Member Agency shall— 

ø(A) use its best efforts to integrate biosurveillance information into the NBIC, with the goal of promoting information sharing between Federal, State, local, and tribal 

governments to detect biological events of national concern; 

ø(B) provide timely information to assist the NBIC in 

maintaining biological situational awareness for accurate 

detection and response purposes; 


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ø(C) enable the NBIC to receive and use biosurveillance 

information from member agencies to carry out its requirements under subsection (c); 

ø(D) connect the biosurveillance data systems of that 

Member Agency to the NBIC data system under mutually 

agreed protocols that are consistent with subsection (c)(5); 

ø(E) participate in the formation of strategy and policy 

for the operation of the NBIC and its information sharing; 

ø(F) provide personnel to the NBIC under an interagency personnel agreement and consider the qualifications of such personnel necessary to provide human, animal, and environmental data analysis and interpretation 

support to the NBIC; and 

ø(G) retain responsibility for the surveillance and intelligence systems of that department or agency, if applicable. 

ø(f) ADMINISTRATIVE AUTHORITIES.— 

ø(1) HIRING OF EXPERTS.—The Directing Officer of the NBIC 

shall hire individuals with the necessary expertise to develop 

and operate the NBIC. 

ø(2) DETAIL OF PERSONNEL.—Upon the request of the Directing Officer of the NBIC, the head of any Federal department 

or agency may detail, on a reimbursable basis, any of the personnel of that department or agency to the Department to assist the NBIC in carrying out this section. 

ø(g) NBIC INTERAGENCY WORKING GROUP.—The Directing Officer of the NBIC shall— 

ø(1) establish an interagency working group to facilitate 

interagency cooperation and to advise the Directing Officer of 

the NBIC regarding recommendations to enhance the biosurveillance capabilities of the Department; and 

ø(2) invite Member Agencies to serve on that working group. 

ø(h) RELATIONSHIP TO OTHER DEPARTMENTS AND AGENCIES.—The 

authority of the Directing Officer of the NBIC under this section 

shall not affect any authority or responsibility of any other department or agency of the Federal Government with respect to biosurveillance activities under any program administered by that department or agency. 

ø(i) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 

to be appropriated such sums as are necessary to carry out this 

section. 

ø(j) DEFINITIONS.—In this section: 

ø(1) The terms ‘‘biological agent’’ and ‘‘toxin’’ have the meanings given those terms in section 178 of title 18, United States 

Code. 

ø(2) The term ‘‘biological event of national concern’’ means— 

ø(A) an act of terrorism involving a biological agent or 

toxin; or 

ø(B) a naturally occurring outbreak of an infectious disease that may result in a national epidemic. 

ø(3) The term ‘‘homeland security information’’ has the 

meaning given that term in section 892. 

ø(4) The term ‘‘Member Agency’’ means any Federal department or agency that, at the discretion of the head of that deVerDate Mar 15 2010 04:59 Sep 15, 2012 Jkt 019006 PO 00000 Frm 00066 Fmt 6659 Sfmt 6601 E:\HR\OC\HR665P1.XXX HR665P1

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partment or agency, has entered a memorandum of understanding regarding participation in the NBIC. 

ø(5) The term ‘‘Privacy Officer’’ means the Privacy Officer 

appointed under section 222.¿ 

* * * * * * * 

TITLE XXI—WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS 

Subtitle A—Prevention 

SEC. 2101. WEAPONS OF MASS DESTRUCTION INTELLIGENCE AND INFORMATION SHARING. 

(a) IN GENERAL.—The Office of Intelligence and Analysis of the 

Department shall— 

(1) conduct intelligence and information sharing activities 

consistent with the National Intelligence Strategy for Countering the Threat from Weapons of Mass Destruction under section 201 of the WMD Prevention and Preparedness Act of 2012 

and the National Intelligence Strategy for Countering Biological Threats under section 202 of that Act; 

(2) support homeland security-focused intelligence analysis of 

terrorist actors, their claims, and their plans to conduct attacks 

involving chemical, biological, radiological, and nuclear materials against the Nation; 

(3) support homeland security-focused intelligence analysis of 

global infectious disease, public health, food, agricultural, and 

veterinary issues; 

(4) support homeland security-focused risk analysis and risk 

assessments of the homeland security hazards described in 

paragraphs (2) and (3), by providing relevant quantitative and 

nonquantitative threat information; 

(5) leverage existing and emerging homeland security capabilities and structures, including fusion centers established pursuant to section 210A, to enhance prevention, protection, response, and recovery efforts with respect to a chemical, biological, radiological, or nuclear attack; 

(6) share information and provide tailored analytical support 

on these threats to State, local, and tribal authorities as well 

as other national biosecurity and biodefense stakeholders; and 

(7) perform other responsibilities, as assigned by the Secretary. 

(b) COORDINATION.—Where appropriate, the Office of Intelligence 

and Analysis shall coordinate with other relevant Department components, others in the Intelligence Community, including the National Counter Proliferation Center, and other Federal, State, local, 

and tribal authorities, including officials from high-threat areas, 

and enable such entities to provide recommendations on optimal information sharing mechanisms, including expeditious sharing of 

classified information, and on how they can provide information to 

the Department. 

(c) REPORT.— 


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(1) IN GENERAL.—Not later than 1 year after the date of the 

enactment of this section and annually thereafter, the Secretary 

shall report to the appropriate congressional committees on— 

(A) the intelligence and information sharing activities 

under subsection (a) and of all relevant entities within the 

Department to counter the threat from weapons of mass destruction; and 

(B) the Department’s activities in accordance with relevant intelligence strategies, including the National Intelligence Strategy for Countering the Threat from Weapons of 

Mass Destruction and the National Intelligence Strategy for 

Countering Biological Threats. 

(2) ASSESSMENT OF IMPLEMENTATION.—The report shall include— 

(A) a description of methods established to assess 

progress of the Office of Intelligence and Analysis in implementing this section; and 

(B) such assessment. 

SEC. 2102. RISK ASSESSMENTS. 

(a) IN GENERAL.—The Secretary, acting through the Under Secretary for Science and Technology, shall, in coordination with relevant Department components and other appropriate Federal departments and agencies— 

(1) produce and update periodically a terrorism risk assessment of chemical, biological, radiological, and nuclear threats; 

and 

(2) produce and update periodically an integrated terrorism 

risk assessment that assesses all of those threats and compares 

them against one another according to their relative risk. 

(b) METHODOLOGY.— 

(1) IN GENERAL.—The Secretary shall— 

(A) convene an interagency task force of relevant subject 

matter experts to assess the proposed methodology to be 

used for assessments required under subsection (a), and to 

provide recommendations to the Secretary as to the adequacy of such methodology; 

(B) conduct sensitivity analysis on each assessment to 

identify and prioritize research activities to close knowledge 

gaps; and 

(C) consider the evolving threat from an intelligent adversary. 

(2) INCLUSION IN ASSESSMENT.—Each assessment under subsection (a) shall include a description of the methodology used 

for the assessment. 

(c) USAGE.—The assessments required under subsection (a) shall 

be used to inform and guide risk management decisions, including— 

(1) the threat assessments and determinations by the Secretary regarding agents and toxins pursuant to section 319F–2 

of the Public Health Service Act; 

(2) allocation of resources for research and development for 

chemical, biological, radiological, and nuclear attack prevention, protection, response, and recovery; 


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(3) prioritization of medical countermeasure research, development, acquisition, and distribution activities and other national strategic biodefense research; 

(4) tailored risk assessments and risk mitigation studies, as 

appropriate, on topics such as radiological materials security or 

the economic risks of a biological attack; and 

(5) other homeland security activities as determined appropriate by the Secretary and the heads of other agencies. 

(d) INPUT AND SHARING.—The Secretary shall, for each assessment required under subsection (a)— 

(1) seek input from national biosecurity and biodefense stakeholders, and other Federal, State, local, and tribal officials involved in efforts to prevent, protect, respond to, and recover 

from chemical, biological, radiological, and nuclear threats; 

(2) ensure that written procedures are in place to guide the 

interagency development of the assessments, including for 

input, review, and implementation purposes, among relevant 

Federal partners; 

(3) share the risk assessments with Federal, State, local and 

tribal officials with appropriate security clearances and a need 

for the information in the classified version; and 

(4) to the maximum extent practicable, make available an unclassified version for Federal, State, local, and tribal officials 

involved in prevention and preparedness for chemical, biological, radiological, and nuclear events. 

(e) WRITTEN PROCEDURES.—The Secretary shall establish written 

procedures for appropriate usage of the assessments required under 

subsection (a), including— 

(1) a description of the types of departmental activities for 

which the assessments should be considered; 

(2) the extent to which the findings of the assessments should 

play a role in such activities; 

(3) the point in planning processes at which the assessments 

should be considered; and 

(4) how users can access expertise within the Department to 

aid in interpretation of the results of the assessments. 

SEC. 2103. NATIONAL EXPORT ENFORCEMENT COORDINATION. 

(a) ESTABLISHMENT.—There shall be maintained in the Department the Export Enforcement Coordination Center, with capability 

for national export enforcement coordination that is managed by the 

Secretary and coordinates the export enforcement activities among 

the Department, the Department of Agriculture, the Department of 

Commerce, the Department of Defense, the Department of Energy, 

the Department of Justice, the Department of State, the Department 

of the Treasury, the Intelligence Community, and other Federal 

agencies as appropriate. 

(b) RESPONSIBILITIES.—The Center shall— 

(1) enhance Federal coordination for law enforcement 

counterproliferation investigations, including coordination and 

deconfliction with intelligence counterproliferation activities; 

(2) address licensing inquiries, reviews, requests, checks, and 

verifications; and 

(3) conduct outreach and provide training to the export trade 

community. 


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SEC. 2104. COMMUNICATION OF THREAT INFORMATION. 

(a) FINDINGS.—Congress finds the following: 

(1) The Commission on the Prevention of Weapons of Mass 

Destruction Proliferation and Terrorism recommended that ‘‘the 

Federal Government should practice greater openness of public 

information so that citizens better understand the threat and 

the risk this threat poses to them’’. 

(2) There are unique challenges for community preparedness 

for attacks from weapons of mass destruction. 

(b) COMMUNICATIONS PLAN.— 

(1) IN GENERAL.—The Administrator of the Federal Emergency Management Agency shall develop a communications 

plan designed to provide information to the public related to 

preventing, preparing for, responding to, and recovering from 

chemical, biological, radiological, and nuclear attacks; 

(2) CONSULTATION.—As appropriate, the Administrator of the 

Federal Emergency Management Agency shall consult with 

State, local, and tribal authorities and coordinate with other 

Federal departments and agencies in developing the communications plans under paragraph (1). 

(3) PRE-SCRIPTED MESSAGES AND MESSAGE TEMPLATES.— 

(A) IN GENERAL.—The Administrator of the Federal 

Emergency Management Agency shall develop and disseminate, through an alerts and warnings system, pre-scripted 

messages and message templates for State, local, and tribal 

authorities so that those authorities can quickly and rapidly disseminate critical information to the public in anticipation of, during, or in the immediate aftermath of a chemical, biological, radiological, and nuclear attack, and to be 

included in the Department of Homeland Security’s lessons 

learned information sharing system. 

(B) DEVELOPMENT AND DESIGN.—The pre-scripted messages or message templates shall— 

(i) be developed in consultation with State, local, and 

tribal authorities and in coordination with other appropriate Federal departments and agencies; 

(ii) be designed to provide accurate, essential, and 

appropriate information and instructions to the population directly affected by an incident, including information regarding an evacuation, sheltering in place, 

hospital surge operations, health, and safety; 

(iii) be designed to provide accurate, essential, and 

appropriate information and instructions to children 

and other special needs populations within the population directly affected by an incident; 

(iv) be designed to provide accurate, essential, and 

appropriate information and instructions to emergency 

response providers and medical personnel responding 

to an incident; and 

(v) include direction for the coordination of Federal, 

State, local, and tribal communications teams. 

(C) COMMUNICATIONS FORMATS.—The Administrator 

shall develop pre-scripted messages or message templates 

under this paragraph in multiple formats to ensure delivery— 


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(i) in cases where the usual communications infrastructure is unusable; 

(ii) to individuals with disabilities or other special 

needs and individuals with limited English proficiency; and 

(iii) to educational and childcare facilities, including 

daycare centers, grade schools, universities, hospitals, 

and elderly care facilities. 

(D) DISSEMINATION AND TECHNICAL ASSISTANCE.—The 

Administrator shall ensure that all pre-scripted messages 

and message templates developed under this paragraph are 

made available to State, local, and tribal authorities so 

that those authorities may incorporate them, as appropriate, into their emergency plans. The Administrator shall 

also make available relevant technical assistance to those 

authorities to support communications planning. 

(E) EXERCISES.—To ensure that the pre-scripted messages 

or message templates developed under this paragraph can 

be effectively utilized in a disaster or incident, the Administrator shall incorporate Federal, State, local, and tribal 

communications teams that deliver such pre-scripted messages or message templates into exercises, including those 

conducted under the National Exercise Program. 

(4) REPORT.—Not later than 1 year after the date of the enactment of this subsection, the Administrator of the Federal Emergency Management Agency shall submit to the appropriate congressional committees the communications plans required to be 

developed under this subsection, including pre-scripted messages or message templates developed in conjunction with the 

plans and a description of the means that will be used to deliver these messages during such incidents. 

(c) TERRORISM THREAT AWARENESS.— 

(1) TERRORISM THREAT AWARENESS.—The Secretary, in coordination with the Attorney General and heads of appropriate 

Federal agencies, shall for purposes of preparedness and collective response to terrorism and for other purposes— 

(A) ensure that homeland security information concerning terrorist threats is provided to State, local, and 

tribal authorities and the public within the United States, 

as appropriate; and 

(B) establish a process to optimize opportunities for 

qualified heads of State, local, and tribal government entities to obtain appropriate security clearances so that they 

may receive classified threat information when appropriate. 

(2) THREAT BULLETINS.— 

(A) IN GENERAL.—Consistent with the requirements of 

paragraph (1), the Secretary shall, on a timely basis, prepare unclassified threat bulletins on chemical, biological, 

radiological, and nuclear threats. 

(B) REQUIREMENTS.—Each assessment required under 

subparagraph (A) shall— 

(i) include guidance to the public for preventing and 

responding to acts of terrorism arising from such 

threats; and 


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(ii) be made available on the Internet Web site of the 

Department and other publicly accessible Internet Web 

sites, communication systems, and information networks. 

(3) GUIDANCE TO STATE, LOCAL, AND TRIBAL AUTHORITIES.— The Secretary, using information provided by the terrorism risk 

assessments under section 2102 and material threat assessments and determinations under the Project BioShield Act of 

2004 (Public Law 108–276) and the amendments made by that 

Act— 

(A) shall provide to State, local, and tribal authorities 

written guidance on communicating terrorism-related 

threats and risks to the public within their jurisdictions; 

and 

(B) shall identify and articulate the governmental rationale for identifying particular communities as being at 

heightened risk of exploitation. 

(4) USE OF EXISTING RESOURCES.—The Secretary shall use 

Internet Web sites, communication systems, and information 

networks in operation on the date of an assessment under this 

subsection, and shall coordinate with other heads of Federal departments and agencies to provide information through existing 

channels to satisfy the requirements of paragraph (2)(B)(ii). The 

Secretary shall provide guidance on how State, local, tribal, 

and private entities can partner with public television stations 

to disseminate information provided by the Department and 

shall provide information on best practices on disseminating information to residents of local communities, including 

leveraging public television stations. 

SEC. 2105. INDIVIDUAL AND COMMUNITY PREPAREDNESS FOR CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR ATTACKS. 

(a) IN GENERAL.—The Secretary, acting through the Administrator for the Federal Emergency Management Agency, shall assist 

State, local, and tribal authorities in improving and promoting individual and community preparedness and collective response to 

terrorist attacks involving chemical, biological, radiological, and 

nuclear materials against the United States by— 

(1) developing guidance and checklists of recommended actions for individual and community prevention and preparedness efforts and disseminating such guidance and checklists to 

communities and individuals; 

(2) updating new and existing guidance and checklists as appropriate; 

(3) disseminating to communities and individuals the guidance developed under section 2131, as appropriate; 

(4) providing information and training materials in support 

of individual and community preparedness efforts; 

(5) conducting individual and community preparedness outreach efforts; and 

(6) such other actions as the Secretary determines appropriate. 

(b) COORDINATION.—The Secretary shall coordinate with Federal 

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paredness and collective response to terrorist attacks involving 

chemical, biological, radiological, and nuclear materials against the 

United States. 

(c) BEST PRACTICES.—In compiling guidance for individual and 

community preparedness in order to carry out subsection (a)(4), the 

Secretary shall give due regard to best practices based on the experience of other agencies and countries and the expertise of academic 

institutions and nongovernmental organizations. 

Subtitle B—Protection 

SEC. 2121. DETECTION OF BIOLOGICAL ATTACKS. 

(a) PROGRAM.—The Secretary shall carry out a program to detect 

a biological attack or event that poses a high risk to homeland security. Through such program, the Secretary shall— 

(1) deploy detection capabilities to areas, based on high risks 

identified by Department assessments, to indicate the presence 

of biological agents; 

(2) consider multiple deployment strategies including surge 

capability; 

(3) provide information to participating laboratories and programs for their use in monitoring public health, and biological 

material or other data from those detectors to participating laboratories and programs for testing and evaluation; 

(4) regularly communicate with, and provide information 

about the presence of biological agents to, appropriate Federal, 

State, and local agencies responsible for public health, law enforcement, and emergency services, in a manner that ensures 

transparency with the governments served by such personnel; 

(5) provide advanced planning tools, concepts of operations 

(including alarm resolution protocols and response guidance), 

standard operating procedures, and training exercises (including in collaboration with relevant national level exercises) for 

collective response to and recovery from biological attacks; and 

(6) provide technical assistance to jurisdictions hosting the 

program to improve their ability to respond to a detected pathogen. 

(b) PROGRAM REQUIREMENTS.—Under the program required 

under subsection (a), the Secretary shall— 

(1) enter into memoranda of agreement or interagency agreements under the Economy Act of 1933 (31 U.S.C. 1535 et seq.) 

with the Director of the Centers of Disease Control and Prevention and the Administrator of the Environmental Protection 

Agency, and the heads of other Federal departments and agencies, setting forth roles and responsibilities, including with respect to validating performance and developing testing protocols 

for participating laboratories and coordination with appropriate State, local, and tribal agencies; 

(2) establish criteria for determining whether plans for biological detector capabilities and coverage sufficiently protect the 

United States population, and make such determinations on an 

annual basis; 

(3) acting through the Under Secretary for Science and Technology, and in consultation with the Director of the Centers for 


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Disease Control and Prevention, implement a process for establishing assay performance standards and evaluation for equivalency for biological threat assays, that— 

(A) evaluates biological threat detection assays, their protocols for use, and their associated response algorithms for 

confirmation of biological threat agents, taking performance measures and concepts of operation into consideration; 

(B) develops interagency peer-reviewed assay performance 

and equivalency standards based on the findings of the 

evaluation under subparagraph (A); 

(C) requires implementation of the standards developed 

under subparagraph (B) for all Department biological detection programs; 

(D) promotes use of such standards among all other Federal biological detection programs and makes them available to the private sector and other end-users as appropriate; and 

(E) is updated as necessary; 

(4) prior to obligating funds to acquire biodetection systems 

for purposes of operational testing and evaluation, require— 

(A) a determination of the sensitivity and specificity of 

the currently deployed biodetection system; 

(B) an assessment of the sensitivity and specificity of the 

next generation biodetection system or systems under consideration for acquisition and whether it meets established 

operational requirements; 

(C) provision of all raw data to the Science and Technology Directorate to enable the Under Secretary to— 

(i) conduct a trade-off study comparing the results of 

subparagraphs (A) and (B); and 

(ii) perform a technical readiness assessment in accordance with section 308(b); and 

(D) that the findings under subparagraph (C) inform the 

cost-benefit analysis under paragraph (5)(A) and any Departmental acquisition review board decision regarding the 

biodetection system or systems under consideration; and 

(5) prior to acquiring and deploying biodetection technology, 

require— 

(A) a cost-benefit analysis, including an analysis of alternatives, that shall be informed by the terrorism risk assessments under section 2102; 

(B) operational testing and evaluation; 

(C) operational assessment by the end users of the technology; and 

(D) the Department, other relevant executive agencies, 

and local jurisdictions intended to host the systems to agree 

on concepts of operations for resolving alarms. 

(c) CONTRACT AUTHORITY.—The Secretary may enter into contracts with participating laboratories and programs for— 

(1) the provision of laboratory services or other biosurveillance activities as appropriate for purposes of this section on a 

fee-for-service basis or on a prepayment or other similar basis; 

and 

(2) administrative and other costs related to hosting program 

personnel and equipment in these laboratories or programs. 


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(d) DEFINITIONS.—In this section: 

(1) The term ‘‘participating laboratory’’ means a laboratory 

that has been accepted as a member of the Laboratory Response 

Network for Biological Terrorism that— 

(A) is fully equipped to detect and respond quickly to acts 

of biological terrorism; 

(B) provides biocontainment and microbiological analysis 

in support of the Department and relevant law enforcement 

agencies with responsibilities for investigating biological incidents; and 

(C) supports assay evaluation, research and development. 

(2) The term ‘‘assay’’ means any scientific test that is designed 

to detect the presence of a biological threat agent that is of a 

type selected under criteria established by the Secretary. 

SEC. 2122. RAPID BIOLOGICAL THREAT DETECTION AND IDENTIFICATION AT PORTS OF ENTRY. 

(a) IN GENERAL.—The Secretary of Homeland Security shall require the Under Secretary for Science and Technology, in consultation with the heads of other relevant operational components of the 

Department of Homeland Security, to assess whether the development of technological screening capabilities for biological agents, 

pandemic influenza, and other infectious diseases should be undertaken by the Directorate of Science and Technology to support entry 

and exit screening at ports of entry and for other homeland security 

purposes. 

(b) DEVELOPMENT OF METHODS.—If the Under Secretary determines that the development of such screening capabilities should be 

undertaken, the Secretary shall, to the extent possible, initiate development of safe and effective methods to— 

(1) rapidly screen incoming persons at ports of entry for biological agents, pandemic influenza, and other infectious diseases; and 

(2) obtain results of such screening near the point of entry. 

SEC. 2123. EVALUATING DETECTION TECHNOLOGY. 

To inform the purchase of detection technology, the Secretary, in 

coordination with the Director of the National Institute of Standards and Technology, may carry out a program to— 

(1) establish near-term minimum performance metrics to support public safety actionable activities, based to the greatest extent practicable on voluntary consensus standards, to evaluate 

the effectiveness of detection technology for high-priority biological agents and toxins and high-priority chemical agents; 

(2) establish a process for voluntary testing and evaluation of 

technology by an accredited laboratory to demonstrate conformance to such consensus standards, or performance metrics if 

standards do not exist, for the effective detection of high-priority 

biological agents and toxins and high-priority chemical agents, 

including incentivization for the program through potential cost 

sharing with technology manufacturers and for SAFETY Act 

certification or placement on the authorized equipment list, or 

both; and 

(3) with permission from the detection technology manufacturer, make available to Federal departments and agencies, 

State, territorial, local, and tribal entities, and the private secVerDate Mar 15 2010 04:59 Sep 15, 2012 Jkt 019006 PO 00000 Frm 00075 Fmt 6659 Sfmt 6603 E:\HR\OC\HR665P1.XXX HR665P1

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tor the results of detection system testing and evaluation under 

paragraph (2). 

SEC. 2124. DOMESTIC IMPLEMENTATION OF THE GLOBAL NUCLEAR 

DETECTION ARCHITECTURE. 

(a) SECURING THE CITIES.—The Director of the Domestic Nuclear 

Detection Office shall establish and maintain a multilayered system 

of detection technologies, programs, and guidelines designed to enhance the Nation’s ability to detect and prevent a radiological or 

nuclear attack in high-risk United States cities, as determined by 

the Secretary. 

(b) SURGE CAPABILITIES.—The Director shall develop a surge capability for radiological and nuclear detection systems that can be 

deployed within the United States rapidly in response to actionable 

intelligence or warnings, and includes procurement of appropriate 

technology, training, and exercises. 

(c) INTEGRATION.—The programs under subsections (a) and (b) 

shall be integrated into the Global Nuclear Detection Architecture 

and shall inform architecture studies, technology gaps, and research 

activities of the Domestic Nuclear Detection Office. 

Subtitle C—Response 

SEC. 2131. FIRST RESPONDER GUIDANCE CONCERNING CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR ATTACKS. 

(a) ESTABLISHMENT OF VOLUNTARY GUIDANCE.—Not later than 1 

year after the date of the enactment of this section, the Secretary, 

in coordination with the Secretary of Health and Human Services, 

the Secretary of Agriculture, the Administrator of the Environmental Protection Agency, the Attorney General, and the heads of 

other Federal departments and agencies, as appropriate, shall— 

(1) develop for police, fire, emergency medical services, emergency management, and medical and public health personnel, 

voluntary guidance for responding to a release of chemical, biological, radiological, and nuclear material; 

(2) make such guidance available to State, local, and tribal 

authorities, including primary and secondary schools and other 

educational institutions, nongovernmental organizations, the 

private sector, and the public; and 

(3) in developing the guidance under paragraph (1)— 

(A) review the experiences of other countries and the expertise of academic institutions and nongovernmental organizations; and 

(B) consider the unique needs of children and other vulnerable populations. 

(b) CONTENTS.—The guidance developed under subsection (a)(1) 

shall be voluntary, risk-based guidance that shall include— 

(1) protective action guidance for ensuring the security, 

health, and safety of emergency response providers and their 

families and household contacts; 

(2) specific information regarding the effects of the chemical, 

biological, radiological, or nuclear material on those exposed to 

the agent; and 

(3) best practices for emergency response providers to effectively diagnose, handle, and otherwise manage individuals afVerDate Mar 15 2010 04:59 Sep 15, 2012 Jkt 019006 PO 00000 Frm 00076 Fmt 6659 Sfmt 6603 E:\HR\OC\HR665P1.XXX HR665P1

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fected by an incident involving chemical, biological, radiological, or nuclear material. 

(c) REVIEW AND REVISION OF GUIDANCE.—The Secretary shall— 

(1) review the guidance developed under subsection (a)(1) at 

least once every 2 years; 

(2) make revisions to the guidance as appropriate; and 

(3) make any revised guidance available to State, local, and 

tribal authorities, nongovernmental organizations, the private 

sector, and the public. 

(d) PROCEDURES FOR DEVELOPING AND REVISING GUIDANCE.—In 

carrying out the requirements of this section, the Secretary shall establish procedures to— 

(1) enable members of the first responder and first provider 

community to submit recommendations of areas in which guidance is needed and could be developed under subsection (a)(1); 

(2) determine which entities should be consulted in developing or revising the guidance; 

(3) prioritize, on a regular basis, guidance that should be developed or revised; and 

(4) develop and disseminate the guidance in accordance with 

the prioritization under paragraph (3). 

SEC. 2132. INTEGRATED PLUME MODELING FOR COLLECTIVE RESPONSE. 

(a) DEVELOPMENT.— 

(1) IN GENERAL.—The Secretary shall acquire, use, and disseminate the best available integrated plume models to enable 

rapid response activities following a chemical, biological, nuclear, or radiological attack or event. 

(2) SCOPE.—The Secretary shall— 

(A) identify Federal, State, and local needs regarding 

plume models and ensure the rapid development and distribution of integrated plume models that meet those needs 

to appropriate officials of the Federal Government and 

State, local, and tribal authorities to enable immediate response to a chemical, biological, radiological, or nuclear attack or event; 

(B) establish mechanisms for dissemination by appropriate emergency response officials of the integrated plume 

models described in paragraph (1) to nongovernmental organizations and the public to enable appropriate collective 

response activities; 

(C) ensure that guidance and training in how to appropriately use such models are provided; and 

(D) ensure that lessons learned from assessing the development and dissemination of integrated plume models during exercises administered by the Department are put into 

the lessons learned information sharing system maintained 

by the Department. 

(b) DEFINITIONS.—For purposes of this section: 

(1) The term ‘‘plume model’’ means the assessment of the location and prediction of the spread of agents following a chemical, biological, radiological, or nuclear attack or event. 

(2) The term ‘‘integrated plume model’’ means a plume model 

that integrates protective action guidance and other information 

as the Secretary determines appropriate. 


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SEC. 2133. ESTABLISHMENT OF THE SYSTEM ASSESSMENT AND VALIDATION FOR EMERGENCY RESPONDERS (SAVER) PROGRAM. 

The Secretary shall carry out a program for system assessment 

and validation of emergency response equipment at the Department, 

to be known as the ‘‘SAVER Program’’. The Secretary shall ensure 

that such program— 

(1) conducts objective, impartial, practitioner-relevant, and 

operationally oriented assessments and validations of commercial emergency responder equipment and systems, including 

hand-held detectors for chemical, biological, radiological, and 

nuclear agents; 

(2) prioritizes such evaluation based on the technical results 

obtained from the program established under section 2123, if 

available; 

(3) is supported by a network of scientists who, in coordination with subject matter experts, perform the assessment and 

validation activities using strict scientific and testing protocols; 

(4) provides results along with other relevant equipment information to the emergency response provider community in an 

operationally useful form; 

(5) provides information on equipment that falls within the 

categories listed in the Department’s authorized equipment list; 

(6) provides information that enables decision-makers and responders to better select, procure, use, and maintain emergency 

responder equipment; and 

(7) shares such information nationally with the emergency response provider community. 

SEC. 2134. PAYMENT FOR LABORATORY RESPONSE SERVICES. 

In carrying out their functions, responsibilities, authorities, and 

duties to counter biological terrorism, the Secretary, the Attorney 

General, and the heads of other participating Federal agencies are 

authorized, subject to the availability of appropriations, to enter 

into contracts with laboratories that comprise the Laboratory Response Network for Biological Terrorism and other federally 

networked laboratories that agree to participate in such a contract, 

for the provision of laboratory testing services on a fee-for-service 

basis or on a prepayment or other similar basis. Prior to entering 

into such a contract with any laboratory in the Laboratory Response 

Network for Biological Terrorism, the Secretary, the Attorney General, or the head of any other participating Federal agency shall inform the Centers for Disease Control and Prevention. 

SEC. 2135. BIOFORENSICS CAPABILITIES. 

(a) BIOFORENSICS ANALYSIS CENTER.—There is authorized in the 

Department a bioforensics analysis center to provide support for law 

enforcement and intelligence-related investigations and actions to— 

(1) provide definitive bioforensics analysis in support of the 

executive agencies with primary responsibilities for preventing, 

deterring, responding to, attributing, and recovering from biological attacks; and 

(2) undertake other related bioforensics activities. 

(b) PAYMENT FOR SERVICES.—The center shall charge and retain 

fees to reimburse the cost of any service provided to an executive 

agency that requested such service. 


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(c) DETAILEE PROGRAM.—Subject to the availability of appropriations, the Secretary may implement a program under which executive agencies as considered appropriate by the Secretary provide personnel, on a reimbursable basis, to the center for the purpose of— 

(1) providing training and other educational benefits for such 

stakeholders to help them to better understand the policies, procedures, and laws governing national bioforensics activities; 

and 

(2) bolstering the capabilities and information sharing activities of the bioforensics analysis center authorized under subsection (a) with national biosecurity and biodefense stakeholders. 

SEC. 2136. METROPOLITAN MEDICAL RESPONSE SYSTEM PROGRAM. 

(a) IN GENERAL.—The Secretary shall conduct a Metropolitan 

Medical Response System Program, that shall assist State and local 

governments in preparing for and responding to public health and 

mass casualty incidents resulting from acts of terrorism, natural 

disasters, and other man-made disasters. 

(b) FINANCIAL ASSISTANCE.— 

(1) AUTHORIZATION OF GRANTS.— 

(A) IN GENERAL.—The Secretary, through the Administrator of the Federal Emergency Management Agency, may 

make grants under this section to State and local governments to assist in preparing for and responding to mass 

casualty incidents resulting from acts of terrorism, natural 

disasters, and other man-made disasters. 

(B) CONSULTATION.—In developing guidance for grants 

authorized under this section, the Administrator shall consult with the Chief Medical Officer. 

(2) USE OF FUNDS.—A grant made under this section may be 

used to support the integration of emergency management, 

health, and medical systems into a coordinated response to 

mass casualty incidents caused by any hazard, including— 

(A) to strengthen medical surge capacity; 

(B) to strengthen mass prophylaxis capabilities including 

development and maintenance of an initial pharmaceutical 

stockpile sufficient to protect first responders, their families, 

and immediate victims from a chemical or biological event, 

including the procurement of home medical kits that are 

approved pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.), as applicable; 

(C) to strengthen chemical, biological, radiological, nuclear, and explosive detection, response, and decontamination capabilities; 

(D) to develop and maintain mass triage and pre-hospital 

treatment plans and capabilities; 

(E) for planning; 

(F) to support efforts to strengthen information sharing 

and collaboration capabilities of regional, State, and urban 

areas in support of public health and medical preparedness; 

(G) for medical supplies management and distribution; 

(H) for training and exercises; 


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(I) for integration and coordination of the activities and 

capabilities of public health personnel and medical care 

providers with those of other emergency response providers 

as well as other Federal agencies, the private sector, and 

nonprofit organizations, for the forward movement of patients; and 

(J) for such other activities as the Administrator provides. 

(3) ELIGIBILITY.— 

(A) IN GENERAL.—Except as provided in subparagraph 

(C), any jurisdiction that received funds through the Metropolitan Medical Response System Program in fiscal year 

2009 shall be eligible to receive a grant under this section. 

(B) ADDITIONAL JURISDICTIONS.— 

(i) UNREPRESENTED STATES.— 

(I) IN GENERAL.—Except as provided in subparagraph (C), the Administrator may make grants 

under this section to the metropolitan statistical 

area with the largest population in any State in 

which no jurisdiction received funds through the 

Metropolitan Medical Response Program in fiscal 

year 2009, or in which funding was received only 

through another State. 

(II) LIMITATION.—For each of fiscal years 2012 

through 2014, no jurisdiction that would otherwise 

be eligible to receive grants under subclause (I) 

shall receive a grant under this section if it would 

result in any jurisdiction under subparagraph (A) 

receiving less funding than such jurisdiction received in fiscal year 2009. 

(ii) OTHER JURISDICTIONS.— 

(I) IN GENERAL.—Subject to subparagraph (C), 

the Administrator may determine that additional 

jurisdictions are eligible to receive grants under 

this section. 

(II) LIMITATION.—For each of fiscal years 2012 

through 2014, the eligibility of any additional jurisdiction to receive grants under this section is 

subject to the availability of appropriations beyond 

that necessary to— 

(aa) ensure that each jurisdiction eligible to 

receive a grant under subparagraph (A) does 

not receive less funding than such jurisdiction 

received in fiscal year 2009; and 

(bb) provide grants to jurisdictions eligible 

under clause (i). 

(C) PERFORMANCE REQUIREMENT AFTER FISCAL YEAR

2012.—A jurisdiction shall not be eligible for a grant under 

this subsection from funds available after fiscal year 2012 

unless the Secretary determines that the jurisdiction maintains a sufficient measured degree of capability in accordance with the performance measures issued under subsection (c). 

(4) DISTRIBUTION OF FUNDS.— 


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(A) IN GENERAL.—The Administrator shall distribute 

grant funds under this section to the State in which the jurisdiction receiving a grant under this section is located. 

(B) PASS THROUGH.—Subject to subparagraph (C), not 

later than 45 days after the date on which a State receives 

grant funds under subparagraph (A), the State shall provide the jurisdiction receiving the grant 100 percent of the 

grant funds, and not later than 45 days after the State releases the funds, all fiscal agents shall make the grant 

funds available for expenditure. 

(C) EXCEPTION.—The Administrator may permit a State 

to provide to a jurisdiction receiving a grant under this section 97 percent of the grant funds awarded if doing so 

would not result in any jurisdiction eligible for a grant 

under paragraph (3)(A) receiving less funding than such jurisdiction received in fiscal year 2009. 

(5) REGIONAL COORDINATION.—The Administrator shall ensure that each jurisdiction that receives a grant under this section, as a condition of receiving such grant, is actively coordinating its preparedness efforts with surrounding jurisdictions, 

with the official with primary responsibility for homeland security (other than the Governor) of the government of the State in 

which the jurisdiction is located, and with emergency response 

providers from all relevant disciplines, as determined by the 

Administrator, to effectively enhance regional preparedness. 

(c) PERFORMANCE MEASURES.—The Administrator of the Federal 

Emergency Management Agency, in coordination with the Chief 

Medical Officer, and the National Metropolitan Medical Response 

System Working Group, shall issue performance measures within 1 

year after the date of enactment of this section that enable objective 

evaluation of the performance and effective use of funds provided 

under this section in any jurisdiction. 

(d) METROPOLITAN MEDICAL RESPONSE SYSTEM WORKING GROUP

DEFINED.—In this section, the term ‘‘National Metropolitan Medical 

Response System Working Group’’ means— 

(1) 10 Metropolitan Medical Response System Program grant 

managers, who shall— 

(A) include 1 such grant manager from each region of the 

Agency; 

(B) comprise a population-based cross section of jurisdictions that are receiving grant funds under the Metropolitan 

Medical Response System Program; and 

(C) include— 

(i) 3 selected by the Administrator of the Federal 

Emergency Management Agency; and 

(ii) 3 selected by the Chief Medical Officer; and 

(2) 3 State officials who are responsible for administration of 

State programs that are carried out with grants under this section, who shall be selected by the Administrator. 

(e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to 

be appropriated $42,000,000 to carry out the program for each of 

fiscal years 2012 through 2016. 


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Subtitle D—Recovery 

SEC. 2141. IDENTIFYING AND ADDRESSING GAPS IN RECOVERY CAPABILITIES. 

(a) RISK ASSESSMENT.— 

(1) TAILORED RISK ASSESSMENT.—The Secretary, acting 

through the Under Secretary for Science and Technology and in 

coordination with the Administrator of the Environmental Protection Agency, shall conduct tailored risk assessments to inform prioritization of national recovery activities for chemical, 

biological, radiological, and nuclear incidents, to be updated as 

necessary. 

(2) CONSIDERATIONS.—In conducting the risk assessments 

under paragraph (1), the Secretary shall— 

(A) consult with the Secretary of Health and Human 

Services, the Secretary of Agriculture, the Secretary of the 

Interior, the Chairman of the Nuclear Regulatory Commission, and the heads of other relevant Federal departments 

and agencies; 

(B) consider recovery of both indoor areas and outdoor 

environments; and 

(C) consider relevant studies previously prepared by other 

Federal agencies, or other appropriate stakeholders. 

(3) COLLABORATION.—Upon completion of the risk assessments required by this section, the Secretary shall provide the 

findings to the Administrator of the Environmental Protection 

Agency and heads of other relevant Federal agencies in order 

to inform ongoing and future work, including research and 

guidance development, undertaken by those agencies in recovery 

and remediation from chemical, biological, radiological, or nuclear incidents. 

(b) RESEARCH.—The results of the risk assessment under this section shall inform appropriate Federal research to address the highrisk capability gaps uncovered by each assessment. 

(c) SUBMISSION TO CONGRESS.—The results of each risk assessment shall be submitted to the appropriate congressional committees 

within 30 days after completion of the assessment. 

SEC. 2142. RECOVERY FROM A CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR ATTACK OR INCIDENT. 

(a) ESTABLISHMENT OF GUIDANCE.—The Secretary shall develop 

and issue guidance for clean-up and restoration of indoor and outdoor areas, including subways and other mass transportation facilities, that have been exposed to chemical, biological, radiological, or 

nuclear materials. The Secretary shall develop and issue the guidance, within 24 months after the date of enactment of this section, 

in consultation with— 

(1) the Secretary of Agriculture; 

(2) the Secretary of Commerce; 

(3) the Secretary of Education; 

(4) the Secretary of the Interior; 

(5) the Attorney General; 

(6) the Secretary of Labor; 

(7) the Secretary of Transportation; 

(8) the Secretary of Housing and Urban Development; 


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(9) the Secretary of Health and Human Services; 

(10) the Secretary of Veterans Affairs; 

(11) the Secretary of the Treasury; 

(12) the Administrator of the Environmental Protection Agency; and 

(13) the Administrator of the Small Business Administration. 

(b) CONTENTS.—The guidance developed under subsection (a) 

shall clarify Federal roles and responsibilities for assisting State, 

local, and tribal authorities and include risk-based recommendations for— 

(1) standards for effective decontamination of affected sites; 

(2) standards for safe post-event occupancy of affected sites, 

including for vulnerable populations such as children and individuals with health concerns; 

(3) requirements to ensure that the decontamination procedures for responding organizations do not conflict; 

(4) requirements that each responding organization uses a 

uniform system for tracking costs and performance of clean-up 

contractors; 

(5) maintenance of negative air pressure in buildings; 

(6) standards for proper selection and use of personal protective equipment; 

(7) air sampling procedures; 

(8) development of occupational health and safety plans that 

are appropriate for the specific risk to responder health; and 

(9) waste disposal. 

(c) REVIEW AND REVISION OF GUIDANCE.—The Secretary shall— 

(1) not less frequently than once every 2 years, review the 

guidance developed under subsection (a); 

(2) make revisions to the guidance as appropriate; and 

(3) make the revised guidance available to the Federal Government, State, local, and tribal authorities, nongovernmental 

organizations, the private sector, and the public. 

(d) PROCEDURES FOR DEVELOPING AND REVISING GUIDANCE.—In 

carrying out the requirements of this section, the Secretary shall establish procedures to— 

(1) prioritize issuance of guidance based on the results of the 

risk assessment under section 2131; 

(2) inventory existing relevant guidance; 

(3) enable the public to submit recommendations of areas in 

which guidance is needed; 

(4) determine which entities should be consulted in developing or revising the guidance; 

(5) prioritize, on a regular basis, guidance that should be developed or revised; and 

(6) develop and disseminate the guidance in accordance with 

the prioritization under paragraph (5). 

(e) CONSULTATIONS.—The Secretary shall develop and revise the 

guidance developed under subsection (a), and the procedures required under subsection (d), in consultation with— 

(1) the heads of other Federal departments and agencies that 

are not required to be consulted under subsection (a), as the 

Secretary considers appropriate; 

(2) State, local, and tribal authorities; and 

(3) nongovernmental organizations and private industry. 


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(f) REPORT.—Not later than 1 year after the date of the enactment 

of this section, and annually thereafter, the Secretary shall provide 

appropriate congressional committees with— 

(1) a description of the procedures established under subsection (d); 

(2) any guidance in effect on the date of the report; 

(3) a list of entities to which the guidance described in paragraph (2) was disseminated; 

(4) a plan for reviewing the guidance described in paragraph 

(2), in accordance with subsection (e); 

(5) the prioritized list of the guidance required under subsection (d)(4), and the methodology used by the Secretary for 

such prioritization; and 

(6) a plan for developing, revising, and disseminating the 

guidance. 

SEC. 2143. EXERCISES. 

(a) IN GENERAL.—To facilitate recovery from a chemical, biological, radiological, or nuclear attack or other incident involving chemical, biological, radiological, or nuclear materials and to foster collective response to terrorism, the Secretary shall develop exercises in 

consultation with State, local, and tribal authorities and other appropriate Federal agencies, and, as appropriate, in collaboration 

with national level exercises, including exercises that address, to the 

best knowledge available at the time, analysis, indoor environmental cleanup methods, and decontamination standards, including 

those published in the guidance issued under section 2142. 

(b) LESSONS LEARNED FOR NATIONAL LEVEL EXERCISES.—The 

Secretary shall provide electronically, to the maximum extent practicable, lessons learned reports to each designated representative of 

State, local, and tribal jurisdictions and private sector entities that 

participate in National Level Exercises of the Department. Each lessons learned report shall be tailored to convey information on that 

exercise that could be leveraged to enhance preparedness and response. 

PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC 

HEALTH SERVICE 

* * * * * * * 

PART B—FEDERAL-STATE COOPERATION

* * * * * * * 

SEC. 319F–2. STRATEGIC NATIONAL STOCKPILE AND SECURITY COUNTERMEASURE PROCUREMENTS. 

(a) * * * 

* * * * * * * 

(c) ADDITIONAL AUTHORITY REGARDING PROCUREMENT OF CER- TAIN COUNTERMEASURES; AVAILABILITY OF SPECIAL RESERVE

FUND.— 

(1) * * * 


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(2) DETERMINATION OF MATERIAL THREATS.— (A) MATERIAL THREAT.—The Homeland Security Secretary, in consultation with the Secretary and the heads of 

other agencies as appropriate, shall on an ongoing basis— 

(i) assess current and emerging threats of chemical, 

biological, radiological, and nuclear agents; øand¿ 

(ii) establish criteria for the issuance of a material 

threat determination; 

ø(ii)¿ (iii) determine which of such agents present a 

material threat against the United States population 

sufficient to affect national securityø.¿; and 

(iv) review and reassess determinations under clause 

(iii) to determine whether agents continue to present a 

material threat against the United States population 

sufficient to affect national security and homeland security. 

* * * * * * * 

SEC. 319F–5. NATIONAL MEDICAL COUNTERMEASURE DISPENSING 

STRATEGY. 

(a) DEFINITIONS.—In this section— 

(1) the term ‘‘dispense’’ means to provide medical countermeasures to an affected population in response to a threat or incident; and 

(2) the term ‘‘medical countermeasure’’ means a qualified 

countermeasure (as defined in section 319F–1(a)(2)). 

(b) STRATEGY.— (1) IN GENERAL.—The Secretary, in coordination with the Secretary of Homeland Security, the Secretary of Agriculture, and 

other appropriate Federal agencies, shall develop, implement, 

and, as appropriate, periodically update a National Medical 

Countermeasure Dispensing Strategy to enhance preparedness 

and collective response to a terrorist attack on humans or animals with any chemical, biological, radiological, or nuclear material, that delineates Federal, State, and local responsibilities. 

(2) CONSIDERATIONS.—The strategy shall be sufficiently flexible to meet the unique needs of different communities, including 

first responders, and shall consider— 

(A) a variety of options for dispensing medical countermeasures, including to individuals, schools, universities, 

hospitals, and elderly care facilities; 

(B) post-incident requirements for emergency use authorizations before countermeasures can be distributed legally; 

(C) the inclusion of locally held caches of countermeasures in event-specific authorizations covering federally 

held countermeasures of the same type; and 

(D) distribution to the public of home medical kits for 

personal stockpiling purposes, within 30 days after a domestic or international bioterrorist attack resulting in 

human infection. 

(c) COORDINATION.—The Secretary shall coordinate with the Administrator of the Federal Emergency Management Agency, State, 

local, and tribal authorities, representatives from the private sector, 

and nongovernmental organizations on the National Medical Countermeasures Dispensing Strategy. 


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(d) REPORT.—Not later than 1 year after the date of the enactment 

of this section, the Secretary shall submit the National Medical 

Countermeasures Dispensing Strategy to the appropriate congressional committees. 

* * * * * * * 

PART F—LICENSING—BIOLOGICAL PRODUCTS AND CLINICAL

LABORATORIES

Subpart 1—Biological Products 

* * * * * * * 

SEC. 351A. ENHANCED CONTROL OF DANGEROUS BIOLOGICAL 

AGENTS AND TOXINS. 

(a) * * * 

* * * * * * * 

(e) SAFEGUARD AND SECURITY REQUIREMENTS FOR REGISTERED

PERSONS.— 

(1) * * * 

* * * * * * * 

(3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY GENERAL.— 

(A) IN GENERAL.—Upon the receipt of names and other 

identifying information under paragraph (2)(B), the Attorney General shall, for the sole purpose of identifying 

whether the individuals involved are within any of the categories specified in subparagraph (B), promptly use criminal, immigration, national security, and other electronic 

databases that are available to the Federal Government 

and are appropriate for such purpose. In identifying whether an individual is within a category specified in subparagraph (B)(ii)(II), the Attorney General shall consult with 

the Secretary of Homeland Security, the Secretary of Defense, and the Secretary of State to determine whether these 

officials possess any information relevant to the identification of such an individual by the Attorney General. 

* * * * * * * 


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ADDITIONAL VIEWS 

While I agree with most of views expressed in the underlying report, it is unfortunate that the report seems to give the impression 

that the President’s decision on how to organize White House-level 

staff to address the WMD threat, on its face, reflects a lack of seriousness about the biosecurity threat. President Obama has shown 

leadership in the area of biosecurity. The President issued a ‘‘National Strategy for Countering Biological Threats’’ in November 

2009 that set forth policies to ensure that the United States will 

be able to prevent, protect against, and respond to both naturallyoccurring and man-made biological events by engaging in prevention activities at home and engaging with the international community. 

As for the involvement of the ‘‘WMD Coordinator’’ in biosecurity 

efforts, I would note that the WMD Coordinator’s office played a 

significant role in the December 2011 Biological Weapons Convention Review Conference. Additionally, the WMD Coordinator’s office 

was a key player in development of the aforementioned strategy to 

counter biological threats. 

I agree that more can and should be done to protect the United 

States from a biological attack. At the same time, I also believe the 

current Administration’s efforts in this regard ought to be recognized. 

BENNIE G. THOMPSON. 

Æ 


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