IB 

Union Calendar No. 411 

111TH CONGRESS 

2D SESSION H. R. 5498 

[Report No. 111–659, Part I] 

To enhance homeland security by improving efforts to prevent, deter, prepare 

for, detect, attribute, respond to, and recover from an attack with a 

weapon of mass destruction, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 10, 2010 

Mr. PASCRELL (for himself, Mr. KING of New York, Mr. THOMPSON of Mississippi, Ms. CLARKE, and Mr. DANIEL E. LUNGREN of California) introduced the following bill; which was referred to the Committee on Homeland Security, and in addition to the Committees on Energy and Commerce, Agriculture, Transportation and Infrastructure, Foreign Affairs, 

and Select Intelligence (Permanent Select), for a period to be subsequently determined by the Speaker, in each case for consideration of such 

provisions as fall within the jurisdiction of the committee concerned 

NOVEMBER 18, 2010 

Reported from the Committee on Homeland Security with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

NOVEMBER 18, 2010 

The Committees on Agriculture, Foreign Affairs, Transportation and Infrastructure, and the Permanent Select Committee on Intelligence discharged 

NOVEMBER 18, 2010 

Referral to the Committee on Energy and Commerce extended for a period 

ending not later than December 3, 2010 

DECEMBER 3, 2010 

Referral to the Committee on Energy and Commerce extended for a period 

ending not later than December 17, 2010 


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DECEMBER 17, 2010 

Referral to the Committee on Energy and Commerce extended for a period 

ending not later than December 21, 2010 

DECEMBER 21, 2010 

Referral to the Committee on Energy and Commerce extended for a period 

ending not later than December 22, 2010 

DECEMBER 22, 2010 

Additional sponsors: Ms. RICHARDSON, Mrs. MILLER of Michigan, Ms. JACKSON LEE of Texas, Mr. CARNEY, Ms. NORTON, Mr. AL GREEN of Texas, 

and Mr. DENT

DECEMBER 22, 2010 

The Committee on Energy and Commerce discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be 

printed 

[For text of introduced bill, see copy of bill as introduced on June 10, 2010] 

A BILL 

To enhance homeland security by improving efforts to prevent, deter, prepare for, detect, attribute, respond to, 

and recover from an attack with a weapon of mass 

destruction, and for other purposes. 


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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘WMD Prevention and Preparedness Act of 2010’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Definitions. 

TITLE I—INTELLIGENCE MATTERS 

Sec. 101. National intelligence strategy for countering the threat from weapons of 

mass destruction. 

Sec. 102. National intelligence strategy for countering biological threats. 

TITLE II—HOMELAND SECURITY MATTERS 

Sec. 201. Weapons of mass destruction prevention and preparedness. 

Sec. 202. Definitions. 

Sec. 203. Dual-use terrorist risks from synthetic genomics. 

Sec. 204. Dissemination of information analyzed by the Department to State, 

local, tribal, and private entities with responsibilities relating to 

homeland security. 

Sec. 205. National Biosurveillance Integration Center (NBIC). 

Sec. 206. Report on establishment of the system assessment and validation for 

emergency responders (SAVER) program. 

Sec. 207. National Academy of Sciences study of forensic science in homeland security. 

Sec. 208. Harmonization of regulations. 

Sec. 209. Communications planning for weapons of mass destruction information 

dissemination. 

Sec. 210. Environmental recovery from chemical, biological, radiological, and nuclear attacks. 

TITLE III—PUBLIC HEALTH MATTERS 

Sec. 301. National medical countermeasure dispensing strategy. 

Sec. 302. Material threat assessments and determinations. 

Sec. 303. National pre-event vaccination and antimicrobial dispensing policy review. 

Sec. 304. Designation of tier 1 material threat agents. 

Sec. 305. Background checks. 

Sec. 306. Biotechnology research, development, and procurement. 

TITLE IV—FOREIGN RELATIONS MATTERS 

Sec. 401. International collaboration and information sharing relating to biosecurity. 


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Sec. 402. International engagement to enhance biodefense and biosecurity. 

Sec. 403. Interagency task force on best practices for global biopreparedness. 

Sec. 404. Biological and Toxin Weapons Convention. 

1 SEC. 2. DEFINITIONS. 

2 In this Act: 

3 (1) The term ‘‘appropriate congressional com4 mittees’’ means the Committee on Homeland Security 

5 of the House of Representatives and any committee of 

6 the House of Representatives or the Senate having leg7 islative jurisdiction under the rules of the House of 

8 Representatives or Senate, respectively, over the mat9 ter concerned. 

10 (2) The term ‘‘weapon of mass destruction’’ has 

11 the meaning given that term in section 1403(1) fo the 

12 Defense Against Weapons of Mass Destruction Act of 

13 1996 (50 U.S.C. 2302). 

14 (3) The term ‘‘Intelligence Community’’ has the 

15 meaning given that term in section 3(4) of the Na16 tional Security Act of 1947 (50 U.S.C. 401a(4)). 

17 (4) The term ‘‘national biosecurity and bio18 defense stakeholders’’ means officials from the Federal, 

19 State, local, and tribal authorities and individuals 

20 from the private sector who are involved in efforts to 

21 prevent, deter, prepare for, detect, attribute, respond, 

22 and recover from a biological attack or other phe23 nomena that may have serious health consequences for 


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1 the United States, including wide-scale fatalities or 

2 infectious disease outbreaks. 

3 TITLE I—INTELLIGENCE 

4 MATTERS 

5 SEC. 101. NATIONAL INTELLIGENCE STRATEGY FOR COUN6 TERING THE THREAT FROM WEAPONS OF 

7 MASS DESTRUCTION. 

8 (a) STRATEGY.— 

9 (1) DEVELOPMENT.—The Director of National 

10 Intelligence, in consultation with the Secretary of 

11 Homeland Security and the heads of other appro12 priate Federal departments and agencies, shall de13 velop and implement— 

14 (A) a strategy designed to improve the ca15 pabilities of the United States to collect, analyze, 

16 and disseminate intelligence related to weapons 

17 of mass destruction; and 

18 (B) a plan to implement such strategy. 

19 (2) TITLE.—The strategy required under para20 graph (1) shall be known as the ‘‘National Intel21 ligence Strategy for Countering the Threat from 

22 Weapons of Mass Destruction’’. 

23 (b) CONTENTS.—The strategy required under sub24 section (a) shall— 


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1 (1) include methods for the recruitment, train2 ing, and retention of a workforce with expertise in the 

3 collection, analysis, and dissemination of intelligence 

4 related to all types of weapons of mass destruction 

5 and science and technology related to weapons of 

6 mass destruction, as well as expertise in science and 

7 technology relating to threats posed by weapons of 

8 mass destruction; 

9 (2) include methods for collaboration, as appro10 priate, with individuals with the expertise described 

11 in paragraph (1) who are not employed by the Fed12 eral Government; 

13 (3) identify and address domestic needs for anal14 ysis and collection including the development of inno15 vative human and technical intelligence collection ca16 pabilities and techniques; and 

17 (4) address each type of weapon of mass destruc18 tion as necessary and appropriate. 

19 (c) IMPLEMENTATION PLAN.—The plan for imple20 menting the strategy required under subsection (a) shall in21 clude— 

22 (1) actions necessary to increase the effectiveness 

23 and efficiency of the sharing of intelligence on weap24 ons of mass destruction throughout the Intelligence 

25 Community, including a description of statutory, regVerDate Mar 15 2010 01:18 Dec 23, 2010 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6203 E:\BILLS\H5498.RH H5498

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1 ulatory, policy, technical, security, or other barriers 

2 that prevent such sharing, and, as appropriate, the 

3 development of uniform standards across the Intel4 ligence Community for such sharing; 

5 (2) methods to disseminate intelligence products 

6 to national biosecurity and biodefense stakeholders in 

7 unclassified formats to increase the effectiveness and 

8 efficiency of the sharing of information; 

9 (3) actions necessary to provide open-source in10 telligence relating to weapons of mass destruction 

11 to— 

12 (A) appropriate Federal departments and 

13 agencies; 

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

15 (C) private entities; 

16 (4) specific objectives to be accomplished, with 

17 corresponding schedule, for each year of the five-year 

18 period that begins on the date on which the strategy 

19 is submitted to the appropriate congressional commit20 tees under subsection (e) and tasks to accomplish such 

21 objectives, including— 

22 (A) a list prioritizing such objectives and 

23 such tasks; and 

24 (B) a schedule for meeting such objectives 

25 and carrying out such tasks; 


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1 (5) assignments of roles and responsibilities to 

2 elements of the Intelligence Community to implement 

3 the strategy; and 

4 (6) a schedule for assessment of the effectiveness 

5 and efficiency of the strategy, including metrics. 

6 (d) COORDINATION.—The Director of National Intel7 ligence shall, as the Director considers appropriate, coordi8 nate with State, local, and tribal government authorities, 

9 private sector, and nongovernmental organizations in the 

10 development of the National Intelligence Strategy for Coun11 tering the Threat from Weapons of Mass Destruction. 

12 (e) REPORT.—Not later than one year after the date 

13 of the enactment of this Act, the Director of National Intel14 ligence, in consultation with the Secretary of Homeland Se15 curity, shall submit to the appropriate congressional com16 mittees the strategy and plan required under subsection (a). 

17 The report shall be in unclassified form but with a classified 

18 annex, as appropriate. 

19 SEC. 102. NATIONAL INTELLIGENCE STRATEGY FOR COUN20 TERING BIOLOGICAL THREATS. 

21 (a) STRATEGY.— 

22 (1) DEVELOPMENT.—The Director of National 

23 Intelligence, in consultation with the Secretary of 

24 Homeland Security and the heads of other appro25 priate Federal departments and agencies, shall deVerDate Mar 15 2010 01:18 Dec 23, 2010 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6203 E:\BILLS\H5498.RH H5498

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1 velop and implement a strategy and a plan for imple2 menting the strategy that is integrated into the Na3 tional Intelligence Strategy for Countering the Threat 

4 from Weapons of Mass Destruction, as required under 

5 this title. 

6 (2) TITLE.—The strategy required under para7 graph (1) shall be known as the ‘‘National Intel8 ligence Strategy for Countering Biological Threats’’. 

9 (b) CONTENTS.—The strategy required under sub10 section (a) shall— 

11 (1) include a for plan for establishing in the In12 telligence Community a cadre of— 

13 (A) collectors and analysts in all agencies 

14 in the Intelligence Community that are familiar 

15 with biological threats, biological science, and 

16 biotechnology; 

17 (B) biological scientists; 

18 (C) biotechologists; and 

19 (D) experts with knowledge of the current 

20 state of technologies that could be used to develop 

21 a weapon of mass destruction; 

22 (2) include a plan for defining the functions, ca23 pabilities, and gaps with respect to addressing the 

24 risk of a weapon of mass destruction attack in the in25 telligence workforce; 


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1 (3) identify strategies to recruit, retain, and pro2 tect such workforce from workplace exposures to bio3 logical agents in the conduct of the duties of such 

4 workforce; 

5 (4) include methods for collaboration, as appro6 priate, with individuals with expertise described in 

7 paragraph (1) who are not employed by the Federal 

8 Government; 

9 (5) address domestic and international needs for 

10 analysis and collection; 

11 (6) include a plan for defining, integrating, fo12 cusing, and enhancing existing capabilities in the In13 telligence Community dedicated to current tactical 

14 and strategic biological threats; and 

15 (7) include a plan for ensuring the prioritization 

16 and sustained commitment of intelligence personnel 

17 and resources to address biological threats. 

18 (c) IMPLEMENTATION PLAN.—The implementation 

19 plan for the strategy required under subsection (a) shall— 

20 (1) include actions necessary to increase the ef21 fectiveness and efficiency of the sharing of intelligence 

22 throughout the Intelligence Community on biological 

23 weapons and organisms that could be used for biologi24 cal terrorism, including a description of statutory, 

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1 riers that prevent such sharing, and, as appropriate, 

2 the development of uniform standards across the In3 telligence Community for such sharing; 

4 (2) address strategic and tactical human intel5 ligence, measurement and signature intelligence, tech6 nical intelligence, medical intelligence, and open7 source intelligence activities necessary to implement 

8 the strategy; 

9 (3) identify specific objectives to be accomplished 

10 during each year of the five-year period that begins 

11 on the date on which the strategy is submitted to the 

12 appropriate congressional committees under sub13 section (d) and tasks to accomplish such objectives, in14 cluding— 

15 (A) a list prioritizing such objectives and 

16 such tasks; and 

17 (B) a schedule for meeting such objectives 

18 and carrying out such tasks; 

19 (4) assign roles and responsibilities to elements 

20 of the Intelligence Community to implement the strat21 egy; 

22 (5) a schedule for assessment of the effectiveness 

23 and efficiency of the strategy, including metrics; and 


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1 (6) a schedule for evaluating on a regular basis 

2 the efforts of the Intelligence Community and progress 

3 on understanding and countering biological threats. 

4 (d) REPORT.—Not later than one year after the date 

5 of the enactment of this Act, the Director of National Intel6 ligence, in consultation with the Secretary of Homeland Se7 curity, shall submit to the appropriate congressional com8 mittees the strategy and plan required under subsection (a). 

9 The report shall be in unclassified form but with a classified 

10 annex, as appropriate. 

11 TITLE II—HOMELAND SECURITY 

12 MATTERS 

13 SEC. 201. WEAPONS OF MASS DESTRUCTION PREVENTION 

14 AND PREPAREDNESS. 

15 (a) IN GENERAL.—The Homeland Security Act of 

16 2002 (6 U.S.C. 101 et seq.) is amended by adding at the 

17 end the following new title: 


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1 ‘‘TITLE XXI—WEAPONS OF MASS 

2 DESTRUCTION PREVENTION 

3 AND PREPAREDNESS 

4 ‘‘Subtitle A—Prevention and 

5 Deterrence 

6 ‘‘SEC. 2101. WEAPONS OF MASS DESTRUCTION INTEL7 LIGENCE AND INFORMATION SHARING UNIT. 

8 ‘‘(a) IN GENERAL.—There is established in the Office 

9 of Intelligence and Analysis of the Department a unit for 

10 weapons of mass destruction intelligence and information 

11 sharing. The unit shall conduct intelligence and informa12 tion sharing activities consistent with the National Intel13 ligence Strategy for Countering the Threat from Weapons 

14 of Mass Destruction under section 101 of the WMD Preven15 tion and Preparedness Act of 2010 and the National Intel16 ligence Strategy for Countering Biological Threats under 

17 section 102 of that Act and shall— 

18 ‘‘(1) evaluate and establish a baseline of terrorist 

19 actors, their claims, and their plans to conduct at20 tacks involving chemical, biological, radiological, and 

21 nuclear materials against the Nation; 

22 ‘‘(2) support homeland security-focused intel23 ligence analysis of global infectious disease, public 

24 health, food, agricultural, and veterinary issues; 


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1 ‘‘(3) provide tailored analytical support on these 

2 threats to State, local, and tribal authorities as well 

3 as members of the public health, scientific, and re4 sponse communities; and 

5 ‘‘(4) perform other responsibilities, as assigned 

6 by the Secretary. 

7 ‘‘(b) COORDINATION.—Where appropriate, the unit 

8 shall coordinate with others in the Intelligence Community, 

9 including the National Counter Proliferation Center. 

10 ‘‘(c) REPORT.—Not later than one year after the date 

11 of the enactment of this section and annually thereafter, the 

12 Secretary shall report to the appropriate congressional com13 mittees on the intelligence and information sharing activi14 ties of the unit for weapons of mass destruction intelligence 

15 and information sharing established under subsection (a) 

16 and all relevant entities within the Department to counter 

17 the threat from weapons of mass destruction and how the 

18 Department acted in accordance with relevant intelligence 

19 strategies, including the National Intelligence Strategy for 

20 Countering the Threat from Weapons of Mass Destruction 

21 and the National Intelligence Strategy for Countering Bio22 logical Threats. 


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1 ‘‘SEC. 2102. INFORMATION SHARING AND COLLABORATION 

2 FOR BIOSECURITY AND BIODEFENSE. 

3 ‘‘(a) RESPONSIBILITIES OF SECRETARY OF HOMELAND

4 SECURITY.—To increase situational awareness, the Sec5 retary, acting through the Under Secretary for Intelligence 

6 and Analysis, shall— 

7 ‘‘(1) to the greatest extent practicable, integrate 

8 into the homeland security, intelligence, and informa9 tion sharing process national biosecurity and bio10 defense stakeholders; 

11 ‘‘(2) develop an information sharing framework 

12 for homeland security intelligence and information 

13 sharing withe national biosecurity and biodefense 

14 stakeholders; 

15 ‘‘(3) enable national biosecurity and biodefense 

16 stakeholders to provide recommendations with respect 

17 to the development of mechanisms and protocols to in18 tegrate information from national biosecurity and 

19 biodefense stakeholders; 

20 ‘‘(4) leverage existing and emerging homeland se21 curity capabilities and structures, including fusion 

22 centers established pursuant to section 210A, to en23 hance prevention, detection, preparedness, and collec24 tive response, attribution, and recovery efforts of from 

25 a biological attack or other phenomena that may have 

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1 cluding wide-scale fatalities or infectious disease out2 breaks; and 

3 ‘‘(5) advance partnerships between the Depart4 ment and other Federal departments and agencies in 

5 assessing potential threats and the risks from the in6 tentional use of biological agents by terrorists or other 

7 actors. 

8 ‘‘(b) COORDINATION WITH OTHER DEPARTMENTS AND

9 AGENCIES.—The Secretary shall work in coordination with 

10 the Secretary of State, the Secretary of Agriculture, the Sec11 retary of Health and Human Services, and the heads of 

12 other appropriate Federal agencies. 

13 ‘‘SEC. 2103. BIOTERRORISM RISK ASSESSMENTS. 

14 ‘‘(a) RISK ASSESSMENT.—The Secretary, in coordina15 tion with the heads of other appropriate Federal depart16 ments and agencies, shall produce biennial integrated risk 

17 assessments, to be known as ‘Bioterrorism Risk Assessments’ 

18 to identify and assess the evolving terrorist risk of a biologi19 cal attack or other phenomena that may have serious health 

20 consequences for the United States, including wide-scale fa21 talities or infectious disease outbreaks. These assessments 

22 shall— 

23 ‘‘(1) identify the threat, vulnerability, and con24 sequences of a biological terrorist attack against the 

25 United States; 


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1 ‘‘(2) take into account intelligence and informa2 tion regarding terrorist intentions, capabilities, plans, 

3 and actions; 

4 ‘‘(3) be used to inform and guide threat assess5 ments and determinations made by the Secretary re6 garding agents and toxins pursuant to section 302(9), 

7 and to guide prioritization of other homeland security 

8 activities, as appropriate; 

9 ‘‘(4) provide the basis for risk-informed invest10 ments in national strategic biodefense research, devel11 opment, planning, preparedness, and collective re12 sponse to biological attacks; 

13 ‘‘(5) identify key knowledge and data gaps; 

14 ‘‘(6) define critical biodefense vulnerabilities; 

15 ‘‘(7) provide risk-based prioritization of agents 

16 for bioterrorism; and 

17 ‘‘(8) evaluate progress in implementing national 

18 biopreparedness policy. 

19 ‘‘(b) REQUIREMENT.—The Secretary shall— 

20 ‘‘(1) convene an interagency task force of subject 

21 matter experts to provide recommendations to the 

22 Under Secretary for Science and Technology as to the 

23 adequacy of the methodology used in the Assessments 

24 and to establish requirements and standards for the 

25 Assessments; 


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1 ‘‘(2) engage with national biosecurity and bio2 defense stakeholders to obtain their input regarding 

3 the Assessments, as appropriate; and 

4 ‘‘(3) ensure, to the greatest extent practicable, 

5 that the Assessments inform the risk management de6 cisions of the Department and can be made available 

7 to national biosecurity and biodefense stakeholders, as 

8 appropriate. 

9 ‘‘SEC. 2104. RADIOLOGICAL MATERIALS SECURITY. 

10 ‘‘(a) RISK ASSESSMENT.—The Secretary shall enhance 

11 domestic preparedness for and collective response to ter12 rorism by conducting annual risk assessments regarding the 

13 threat, vulnerability, and consequences of theft or other pro14 curement of radiological materials that could be used by 

15 a terrorist in a radiological dispersion device, including 

16 any specific threat information pertinent to the use of radi17 ological materials in a possible terrorist attack using a ra18 diological dispersion device. 

19 ‘‘(b) CONSIDERATIONS.—In conducting the terrorism 

20 risk assessments under subsection (a), the Secretary shall— 

21 ‘‘(1) consult with Secretary of Energy, Secretary 

22 of Heath and Human Services, and the Nuclear Reg23 ulatory Commission; 


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1 ‘‘(2) consider relevant studies previously pre2 pared by other Federal agencies, or other reputable 

3 sources; 

4 ‘‘(3) focus on those radiological materials that 

5 constitute the greatest risk, and designate those mate6 rials as high-risk radiological materials for purposes 

7 of this section; 

8 ‘‘(4) consider the potential radiological disper9 sion device value of different radiological materials 

10 including availability, dispersability, and ease of 

11 handling of such materials; 

12 ‘‘(5) consider the vulnerability for theft or other 

13 procurement that different facilities represent; and 

14 ‘‘(6) consider the consequences of a successful ra15 diological dispersion device attack, including risk of 

16 death or injury and economic losses. 

17 ‘‘(c) CONSULTATION.—In conducting the terrorism risk 

18 assessments under subsection (a), the Secretary shall consult 

19 with the Intelligence Community, the Secretary of Energy 

20 and the Field Intelligence Elements of the National Labora21 tories, and the Nuclear Regulatory Commission, the Sec22 retary of Health and Human Services, and other appro23 priate experts to integrate and analyze information needed 

24 to develop the risk assessment. 


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1 ‘‘(d) DISSEMINATION OF FINDINGS.—The Secretary 

2 shall disseminate the findings of the risk assessments and 

3 any specific risk information developed in the assessment 

4 to all participating agencies including those described in 

5 subsection (c), as well State and local agencies, and the fa6 cilities containing radiological source material and regu7 lated by the Nuclear Regulatory Commission. 

8 ‘‘(e) CLASSIFICATION.—The Secretary shall, as appro9 priate, share the terrorism risk assessments with law en10 forcement and critical infrastructure operators with appro11 priate security clearances. The Secretary shall also make 

12 available an unclassified version to each agency with which 

13 the Secretary is required to consult under subsection (c), 

14 as well as State and local law enforcement and public 

15 health authorities, and facilities possessing radiological ma16 terials with the support of the Department of Energy. 

17 ‘‘SEC. 2105. ENHANCED BIOSECURITY MEASURES. 

18 ‘‘(a) REGULATIONS.—At the request of the Secretary, 

19 the Secretary, in consultation with the Secretary of Agri20 culture, the Secretary of Health and Human Services, and 

21 the heads of other appropriate Federal agencies, shall, 

22 through a negotiated rulemaking committee under sub23 chapter III of chapter 5 of title 5, United States Code, estab24 lish enhanced biosecurity measures for persons or laboraVerDate Mar 15 2010 01:18 Dec 23, 2010 Jkt 099200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6203 E:\BILLS\H5498.RH H5498

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1 tories that possess, use, or transfer Tier I Material Threat 

2 Agents. Such measures shall include— 

3 ‘‘(1) standards for personnel surety programs; 

4 ‘‘(2) standards for biosecurity practices and 

5 training of responsible officials, laboratory personnel, 

6 and support personnel; 

7 ‘‘(3) standards for performing laboratory vulner8 ability assessments in collaboration with each facility; 

9 ‘‘(4) risk-based laboratory security performance 

10 standards; 

11 ‘‘(5) penalties (including civil money penalties 

12 and intermediate sanctions), in addition to any other 

13 penalties that may apply under provisions of law; 

14 and 

15 ‘‘(6) any other security standards determined 

16 necessary by the Secretary, the Secretary of Agri17 culture, Secretary of Health and Human Services, 

18 and other agencies as appropriate. 

19 ‘‘(b) NEGOTIATED RULEMAKING COMMITTEE.—The 

20 Secretary shall establish a negotiated rulemaking committee 

21 for purposes of subsection (a). Such committee shall include 

22 a representative from each of the following: 

23 ‘‘(1) The Department. 

24 ‘‘(2) The Department of Health and Human 

25 Services. 


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1 ‘‘(3) The Department of Agriculture. 

2 ‘‘(4) The Department of Defense. 

3 ‘‘(5) The Department of Energy. 

4 ‘‘(6) The Department of Justice. 

5 ‘‘(7) For-profit research institutions. 

6 ‘‘(8) Academic research institutions. 

7 ‘‘(9) Nonprofit research institutions 

8 ‘‘(10) Other stakeholders, as the Secretary deter9 mines appropriate. 

10 ‘‘(c) TIME REQUIREMENT.—The procedures for the ne11 gotiated rulemaking referred to in subsection (a) shall be 

12 conducted in a timely manner to ensure that— 

13 ‘‘(1) any recommendations with respect to pro14 posed regulations are provided to the Secretary and 

15 the heads of the other appropriate Federal agencies 

16 not later than one year after the date of the enact17 ment of this section; and 

18 ‘‘(2) a final rule is promulgated not later than 

19 two years after the date of the enactment of this sec20 tion. 

21 ‘‘(d) FACTORS TO BE CONSIDERED.—In developing 

22 proposed and final standards pursuant to the negotiated 

23 rulemaking referred to in subsection (a), the negotiated 

24 rulemaking committee shall consider— 


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1 ‘‘(1) the Commission on the Prevention of Weap2 ons of Mass Destruction Proliferation and Terrorism 

3 (established under section 1851 of the Implementing 

4 Recommendations of the 9/11 Commission Act of 2007 

5 (Public Law 110–53; 121 Stat. 501)); 

6 ‘‘(2) the National Science Advisory Board for 

7 Biosecurity (established under section 217a of title 42, 

8 United States Code, section 222 of the Public Health 

9 Service Act, and section 205 of the Pandemic and All10 Hazards Preparedness Act); 

11 ‘‘(3) any working group established under Exec12 utive Order 13486 (74 Fed. Reg. 2289) relating to 

13 strengthening laboratory biosecurity; 

14 ‘‘(4) the Chemical Facility Anti-Terrorism Act of 

15 2009; and 

16 ‘‘(5) views from representatives of biosecurity 

17 and biodefense stakeholders for methods to minimize 

18 any disincentives to biological research arising from 

19 enhanced biosecurity measures. 

20 ‘‘(e) IMPLEMENTATION OF ENHANCED BIOSECURITY

21 MEASURES.— 

22 ‘‘(1) ENFORCEMENT.—The Secretary of Agri23 culture and the Secretary of Health and Human 

24 Services, in consultation with the Secretary, as ap25 propriate, shall enforce the measures established under 


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1 subsection (a) and any standards promulgated pursu2 ant to such section. 

3 ‘‘(2) TRAINING PROGRAMS.—The Secretary of 

4 Agriculture and the Secretary of Health and Human 

5 Services, in coordination with the Secretary and the 

6 heads of other Federal agencies, as appropriate, shall 

7 develop training programs that comply with such 

8 measures and standards. 

9 ‘‘(3) PROCEDURES.—The Secretary of Agri10 culture and the Secretary of Health and Human 

11 Services, in consultation with the Secretary and the 

12 heads of other Federal agencies, as appropriate, shall 

13 develop and implement procedures with respect to 

14 when and how penalties and intermediate sanctions 

15 may be imposed. Such procedures shall provide for 

16 notice, a reasonable opportunity to respond to the 

17 proposed penalty or intermediate sanction, and ap18 propriate procedures for appealing determinations re19 lating to the imposition of a penalty or intermediate 

20 sanction. 

21 ‘‘(4) SIMULTANEOUS LABORATORY INSPEC22 TIONS.— 

23 ‘‘(A) INSPECTION DATA SHARING AND EN24 FORCEMENT UNIFORMITY.—The Secretary of Ag25 riculture and the Secretary of Health and 


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1 Human Services shall periodically provide the 

2 Secretary with all data concerning inspections of 

3 laboratories that handle Tier 1 Material Threat 

4 Agents to ensure uniformity in enforcement of 

5 the regulations enacted under subsection (a) and 

6 to identify areas where the Secretary can provide 

7 guidance to the Secretary of Agriculture or the 

8 Secretary of Health and Human Services about 

9 approaches to enhance security at specific lab10 oratories. 

11 ‘‘(B) SIMULTANEOUS INSPECTIONS.—Any 

12 inspections of the same laboratory conducted by 

13 the Secretary of Agriculture pursuant to section 

14 212(a)(1) of the Agricultural Bioterrorism Pro15 tection Act of 2002 and the Secretary of Health 

16 and Human Services for compliance with regu17 lations promulgated under the Select Agent Pro18 gram under section 351A(a)(1) of the Public 

19 Health Service Act, shall be conducted simulta20 neously to the extent practicable. 

21 ‘‘(C) COMMON INSPECTION PROCEDURES.— 

22 Departments conducting simultaneous inspec23 tions of a laboratory under this subsection shall 

24 ensure, to the maximum extent practicable, that 

25 such inspections are conducted using a common 


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1 set of inspection procedures across such depart2 ments in order to minimize the administrative 

3 burden on such laboratory. 

4 ‘‘(D) INSPECTION REPORTS.—Inspection re5 ports generated under this paragraph shall be 

6 made available to each Federal agency that sup7 ports select agent laboratory activities at the in8 stitution that is the subject of the inspection re9 port, and to the institutions that are the object 

10 of inspections. 

11 ‘‘SEC. 2106. TIER I MATERIAL THREAT AGENT LOCATIONS. 

12 ‘‘The Secretary of Agriculture and the Secretary of 

13 Health and Human Services shall provide to the Secretary 

14 a list of laboratories and other locations where Tier I Mate15 rial Threat Agents are present in the United States and 

16 its territories. 

17 ‘‘SEC. 2107. HIGH CONTAINMENT BIOLOGICAL LABORATORY 

18 SECURITY GRANTS. 

19 ‘‘(a) GRANTS AUTHORIZED.—The Secretary, acting 

20 through the Administrator of the Federal Emergency Man21 agement Agency, may award grants based on risk to aca22 demic and nonprofit organizations and to State, local, and 

23 tribal authorities that possess, use, or transfer Tier I Mate24 rial Threat Agents, to enhance security at laboratories of 

25 such organizations and authorities. 


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1 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There is 

2 authorized to be appropriated to the Department of Home3 land Security to carry out this subsection $50,000,000 for 

4 each of fiscal years 2011 through 2013. 

5 ‘‘SEC. 2108. LABORATORY BIOSECURITY INFORMATION 

6 SHARING. 

7 ‘‘(a) IN GENERAL.—Consistent with the responsibil8 ities of the Secretary under section 201(d), the Secretary 

9 shall establish procedures, with appropriate controls on ac10 cess, for the sharing of homeland security information, in11 cluding vulnerability assessments, security plans, best prac12 tices and other laboratory biosecurity-related information, 

13 as the Secretary determines appropriate, with State, local, 

14 and tribal government authorities, including law enforce15 ment authorities and emergency response providers. 

16 ‘‘(b) ACCESS TO INFORMATION IN DATABASES.—In 

17 carrying out this section, the Secretary shall have access 

18 to and may use information from the national databases 

19 established under section 212(d)(2) of the Agricultural Bio20 terrorism Protection Act of 2002 (7 U.S.C. 8401(d)(2)) and 

21 subsections (d)(2) and (f)(3) of section 351A of the Public 

22 Health Service Act (42 U.S.C. 262a). 

23 ‘‘(c) CLASSIFIED AND SENSITIVE INFORMATION.—The 

24 Secretary shall ensure that any information disseminated 

25 under this section is handled consistent with— 


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1 ‘‘(1) the authority of the Director of National In2 telligence to protect intelligence sources and methods 

3 under the National Security Act of 1947 (50 U.S.C. 

4 401 et seq.) and related procedures or similar au5 thorities of the Attorney General concerning sensitive 

6 law enforcement information; 

7 ‘‘(2) section 552a of title 5, United States Code 

8 (commonly referred to as the Privacy Act of 1974); 

9 and 

10 ‘‘(3) other relevant laws. 

11 ‘‘SEC. 2109. PERIODIC HOMELAND SECURITY REVIEW OF 

12 CRIMINAL STATUTES. 

13 ‘‘(a) IN GENERAL.—The Secretary, in coordination 

14 with the Attorney General and the heads of other Federal 

15 departments and agencies, as appropriate, shall, for pur16 poses of enhancing homeland security— 

17 ‘‘(1) periodically review and recommend updates 

18 to criminal laws to ensure that such laws are well 

19 suited to the evolving risks of misuse of life sciences 

20 by terrorists and others; and 

21 ‘‘(2) ensure that national biosecurity and bio22 defense stakeholders at unique risk of exploitation 

23 have access to guidance regarding actions that can re24 duce the risk of misuse of life sciences by terrorists 

25 and others. 


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1 ‘‘(b) REPORT.—Not later than one year after the date 

2 of the enactment of this section, and biannually thereafter, 

3 the Secretary, in coordination with the Attorney General, 

4 shall submit to the appropriate congressional committees 

5 the recommended updates to criminal laws, as described in 

6 subsection (a)(1). 

7 ‘‘SEC. 2110. EXPORT ENFORCEMENT FOR COUNTER-PRO8 LIFERATION. 

9 ‘‘(a) IN GENERAL.—The Secretary, in coordination 

10 with the Secretary of Commerce, the Secretary of Defense, 

11 the Attorney General, the Secretary of State, the Director 

12 of National Intelligence, and the heads of other appropriate 

13 Federal agencies shall— 

14 ‘‘(1) conduct homeland security investigations 

15 and enforce criminal violations of customs and export 

16 laws of the United States related to military items, 

17 controlled commodities, and sanctioned or embargoed 

18 countries to prevent individuals, terrorist groups, for19 eign adversaries, and hostile nations from— 

20 ‘‘(A) illegally obtaining sensitive United 

21 States technology and munitions; and 

22 ‘‘(B) obtaining weapons of mass destruction 

23 components, precursors, and delivery systems, in24 cluding— 


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1 ‘‘(i) United States military technical 

2 data, hardware, small arms and defense 

3 services; 

4 ‘‘(ii) dual-use technical data/source 

5 code and commodities; and 

6 ‘‘(iii) deemed exports; and 

7 ‘‘(2) conduct industry outreach with manufac8 turers and exporters of strategic commodities that 

9 may be targeted for procurement by terrorist organi10 zations and the countries that support them as well 

11 as countries identified as weapons proliferators, in a 

12 manner that acknowledges commerce and trade, by— 

13 ‘‘(A) educating companies and individuals 

14 on the export laws of the United States; 

15 ‘‘(B) discussing export licensing issues and 

16 requirements; 

17 ‘‘(C) identifying red flag indicators used in 

18 illegal procurement; 

19 ‘‘(D) identifying the government agencies 

20 responsible for the licensing of export-controlled 

21 commodities and technology; and 

22 ‘‘(E) establishing and fostering relationships 

23 whereby companies and individuals can report 

24 suspicious contacts or attempts to violate the ex25 port laws of the United States. 


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1 ‘‘(b) NATIONAL EXPORT ENFORCEMENT COORDINA2 TION.— 

3 ‘‘(1) ESTABLISHMENT; MEMBERSHIP.—There is 

4 established in the Department a unit responsible for 

5 national export enforcement coordination that is 

6 managed by the Secretary. The unit shall be composed 

7 of members who are representatives from the Depart8 ment, the Department of Commerce, the Department 

9 of Defense, the Department of Energy, the Depart10 ment of Justice, the Department of State, the Intel11 ligence Community, and other Federal agencies as ap12 propriate. 

13 ‘‘(2) RESPONSIBILITIES.—The unit shall carry 

14 out the following responsibilities: 

15 ‘‘(A) Coordinating law enforcement counter16 proliferation investigations and intelligence 

17 counter-proliferation activities. 

18 ‘‘(B) Addressing licensing inquiries, re19 views, requests, checks, and verifications. 

20 ‘‘(C) Conducting outreach and providing 

21 training to the export trade community. 


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1 ‘‘Subtitle B—Preparedness 

2 ‘‘SEC. 2121. COMMUNICATION OF THREAT INFORMATION 

3 AND ALERTS. 

4 ‘‘(a) FINDINGS.—Congress makes the following find5 ings: 

6 ‘‘(1) The Commission on the Prevention of 

7 Weapons of Mass Destruction Proliferation and Ter8 rorism recommended that ‘the Federal Government 

9 should practice greater openness of public information 

10 so that citizens better understand the threat and the 

11 risk this threat poses to them’. 

12 ‘‘(2) There are unique challenges for community 

13 preparedness for attacks from weapons of mass de14 struction and their agents. 

15 ‘‘(b) TERRORISM THREAT AWARENESS.— 

16 ‘‘(1) TERRORISM THREAT AWARENESS.—The 

17 Secretary, in coordination with the heads of appro18 priate Federal agencies, shall ensure that homeland 

19 security information concerning terrorist threats is 

20 provided to State, local, and tribal authorities and 

21 the public within the United States, as appropriate, 

22 for purposes of preparedness and collective response to 

23 terrorism and for other purposes. 

24 ‘‘(2) THREAT BULLETINS.— 


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1 ‘‘(A) IN GENERAL.—Consistent with the re2 quirements of paragraph (1), the Secretary shall, 

3 on a timely basis, prepare unclassified ter4 rorism-related threat and risk assessments. 

5 ‘‘(B) REQUIREMENTS.—Each assessment re6 quired under subparagraph (A) shall— 

7 ‘‘(i) include guidance to the public for 

8 preventing and responding to acts of ter9 rorism; and 

10 ‘‘(ii) be made available on the Internet 

11 website of the Department and other pub12 licly accessible Internet websites, commu13 nication systems, and information net14 works. 

15 ‘‘(3) GUIDANCE TO STATE, LOCAL, AND TRIBAL

16 AUTHORITIES.—The Secretary— 

17 ‘‘(A) acting through the Administrator of 

18 the Federal Emergency Management Agency, 

19 shall provide to State, local, and tribal authori20 ties written guidance on communicating ter21 rorism-related threats and risks to the public 

22 within their jurisdictions; and 

23 ‘‘(B) shall identify and articulate the gov24 ernmental rationale for identifying particular 


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1 communities as being at heightened risk of ex2 ploitation. 

3 ‘‘(4) USE OF EXISTING RESOURCES.—The Sec4 retary shall use Internet websites, communication sys5 tems, and information networks in operation on the 

6 date of an assessment under this subsection to satisfy 

7 the requirements of paragraph (2)(B)(ii). The Sec8 retary shall provide guidance on how State, local, 

9 tribal, and private entities can partner with public 

10 television stations to disseminate information pro11 vided by the Department and shall provide informa12 tion on best practices on disseminating information 

13 to residents of local communities, including 

14 leveraging public television stations. 

15 ‘‘SEC. 2122. INDIVIDUAL AND COMMUNITY PREPAREDNESS 

16 FOR WEAPONS OF MASS DESTRUCTION. 

17 ‘‘(a) IN GENERAL.—The Secretary, acting through the 

18 Administrator for the Federal Emergency Management 

19 Agency, shall assist State, local, and tribal authorities in 

20 improving and promoting individual and community pre21 paredness and collective response to weapons of mass de22 struction and terrorist attacks involving chemical, biologi23 cal, radiological, and nuclear materials against the United 

24 States by— 


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1 ‘‘(1) developing guidance and checklists of rec2 ommended actions for individual and community 

3 prevention and preparedness efforts and dissemi4 nating such guidance and checklists to communities 

5 and individuals; 

6 ‘‘(2) disseminating the guidance developed under 

7 section 2151 to communities and individuals, as ap8 propriate; 

9 ‘‘(3) providing information and training mate10 rials in support of individual and community pre11 paredness efforts; 

12 ‘‘(4) conducting individual and community pre13 paredness outreach efforts; and 

14 ‘‘(5) such other actions as the Secretary deter15 mines appropriate. 

16 ‘‘(b) COORDINATION.—Where appropriate, the Sec17 retary shall coordinate with private sector and nongovern18 mental organizations to promote individual and commu19 nity preparedness and collective response to weapons of 

20 mass destruction and terrorist attacks involving chemical, 

21 biological, radiological, and nuclear materials against the 

22 United States. 

23 ‘‘(c) BEST PRACTICES.—In compiling guidance for in24 dividual and community preparedness in order to carry out 

25 subsection (a)(3), the Secretary shall give due regard to best 


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1 practices based on the experience of other countries and 

2 agencies and th expertise of academic institutions and non3 governmental organizations. 

4 ‘‘Subtitle C—Detection 

5 ‘‘SEC. 2131. NATIONAL BIOSURVEILLANCE STRATEGY. 

6 ‘‘(a) CURRENT STATE OF BIOSURVEILLANCE.—The 

7 Secretary shall examine of the state of domestic and global 

8 biosurveillance. 

9 ‘‘(b) STRATEGY FOR BIOSURVEILLANCE.—The Sec10 retary shall submit to the appropriate congressional com11 mittees a national strategy for biosurveillance. 

12 ‘‘(c) MATTERS FOR INCLUSION.— 

13 ‘‘(1) IN GENERAL.—In developing the strategy 

14 required under subsection (b), the Secretary shall take 

15 into consideration— 

16 ‘‘(A) the state of biosurveillance domesti17 cally and internationally; 

18 ‘‘(B) material threat assessments and deter19 minations developed by the Secretary in accord20 ance with the Project BioShield Act of 2004 

21 (Public Law 108–276) and the amendments 

22 made by that Act; 

23 ‘‘(C) reports on global trends produced by 

24 the Office of the Director of National Intelligence 

25 regarding the biological threat; 


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1 ‘‘(D) information available in biosurveil2 lance systems and changes to information tech3 nology to allow for the incorporation and inte4 gration of this information; 

5 ‘‘(E) Intelligence Community needs as ar6 ticulated in relevant intelligence strategies; and 

7 ‘‘(F) costs associated with establishing and 

8 maintaining the necessary infrastructure to inte9 grate biosurveillance systems. 

10 ‘‘(2) ADDITIONAL REQUIREMENTS.—This strat11 egy required under subsection (b) shall— 

12 ‘‘(A) include a plan for advancing situa13 tional awareness; 

14 ‘‘(B) identify key elements of information to 

15 be shared, critical sensitivities to be protected, 

16 and a framework for enabling information ex17 change; 

18 ‘‘(C) include a plan for fostering informa19 tion sharing between law enforcement, security, 

20 intelligence, and national biosecurity and bio21 defense stakeholders to identify potential threats, 

22 reduce vulnerabilities and improve collective re23 sponse activities to and investigations of sus24 pected biological attacks; and 


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1 ‘‘(D) include strategic and implementation 

2 plans for the National Biosurveillance Integra3 tion Center under section 316. 

4 ‘‘SEC. 2132. DETECTION OF BIOLOGICAL ATTACKS. 

5 ‘‘(a) PROGRAM.—The Secretary shall carry out a pro6 gram in the Department to detect a biological attack or 

7 event. Through such program, the Secretary shall— 

8 ‘‘(1) deploy detectors to areas, based on risk, to 

9 indicate the presence of biological agents; 

10 ‘‘(2) provide information to participating lab11 oratories for their use in monitoring public health, 

12 and biological material from these detectors to par13 ticipating laboratories for testing; 

14 ‘‘(3) provide information about the presence of 

15 biological agents to public health and law enforcement 

16 personnel at all levels of government; and 

17 ‘‘(4) provide advanced planning tools, concepts of 

18 operations (including alarm resolution protocols), and 

19 training exercises for collective response to and recov20 ery from biological attacks. 

21 ‘‘(b) PROGRAM REQUIREMENTS.—Under the program 

22 required under subsection (a), the Secretary shall— 

23 ‘‘(1) enter into memoranda of agreement or 

24 interagency agreements under the Economy Act of 

25 1933 (31 U.S.C. 1535 et seq.) with the Director of the 


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1 Centers of Disease Control and Prevention and the 

2 Administrator of the Environmental Protection Agen3 cy, and the heads of other Federal departments and 

4 agencies, setting forth roles and responsibilities, in5 cluding with respect to filter testing protocols for par6 ticipating laboratories and coordination with appro7 priate State, local, and tribal agencies; 

8 ‘‘(2) determine, on an annual basis, whether 

9 plans for biological detector capabilities and coverage 

10 sufficiently protect the United States population; and 

11 ‘‘(3) acting through the Under Secretary for 

12 Science and Technology, and in consultation with the 

13 Director for the Centers for Disease Control and Pre14 vention, implement an assay equivalency program for 

15 biological threat assays that— 

16 ‘‘(A) may evaluate biological threat detec17 tion assays, their protocols for use, and their as18 sociated response algorithms for confirmation of 

19 biological threat agents, taking performance 

20 measures and concepts of operation into consid21 eration; 

22 ‘‘(B) may develop assay equivalency stand23 ards based on the findings of the evaluation 

24 under subparagraph (A); 

25 ‘‘(C) will be updated as necessary; 


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1 ‘‘(D) shall require implementation of the 

2 standards developed under subparagraph (B) for 

3 all Department biological detection programs; 

4 and 

5 ‘‘(E) shall make such standards available to 

6 support all other Federal biological detection 

7 programs. 

8 ‘‘(c) CONTRACT AUTHORITY.—The Secretary is author9 ized to enter into contracts with participating laboratories 

10 for— 

11 ‘‘(1) the provision of laboratory services to test 

12 detector filters on a fee-for-service basis or on a pre13 payment or other similar basis; and 

14 ‘‘(2) administrative and other costs related to 

15 hosting program personnel and equipment in these 

16 laboratories. 

17 ‘‘(d) DEFINITIONS.—In this section: 

18 ‘‘(1) The term ‘participating laboratory’ means 

19 a laboratory that has been accepted as a member of 

20 the Laboratory Response Network for Bioterrorism 

21 that— 

22 ‘‘(A) is fully equipped to detect and respond 

23 quickly to acts of biological terrorism; 

24 ‘‘(B) provides biocontainment and micro25 biological analysis in support of the Department, 


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1 the Federal Bureau of Investigation and other 

2 law enforcement agencies with responsibilities for 

3 investigating biological incidents; and 

4 ‘‘(C) supports threat agent characterization 

5 studies and assay evaluation, research and devel6 opment. 

7 ‘‘(2) The term ‘assay’ means any scientific test 

8 that is designed to detect the presence of a biological 

9 threat agent that is of a type selected under criteria 

10 established by the Secretary. 

11 ‘‘SEC. 2133. RAPID BIOLOGICAL THREAT DETECTION AND 

12 IDENTIFICATION. 

13 ‘‘(a) IN GENERAL.—Notwithstanding section 302(4) 

14 the Secretary shall require the Under Secretary for Science 

15 and Technology, in consultation with the heads of other rel16 evant operational components of the Department, assess 

17 whether the development of screening capabilities for bio18 logical agents, pandemic influenza, and other infectious dis19 eases should be undertaken by the Science and Technology 

20 Directorate to support entry and exit screening at ports of 

21 entry and for other purposes. 

22 ‘‘(b) DEVELOPMENT OF METHODS.—If the Under Sec23 retary determines that the development of such screening 

24 capabilities should be undertaken, the Secretary shall, to the 

25 extent possible, initiate development of safe and effective 


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1 methods to rapidly screen incoming travelers at ports of 

2 entry for biological agents, pandemic influenza, and other 

3 infectious diseases. 

4 ‘‘(c) COLLABORATION.—In developing methods under 

5 subsection (b), the Secretary may collaborate with the heads 

6 of other Federal agencies, as needed. 

7 ‘‘SEC. 2134. ESTABLISHMENT OF THE SYSTEM ASSESSMENT 

8 AND VALIDATION FOR EMERGENCY RE9 SPONDERS (SAVER) PROGRAM. 

10 ‘‘The Secretary, acting through the Under Secretary 

11 for Science and Technology, shall carry out a program for 

12 system assessment and validation of emergency response 

13 equipment at the Department, to be known as the ‘SAVER 

14 Program’. The Secretary shall ensure that such program— 

15 ‘‘(1) conducts objective, impartial, practitioner16 relevant, and operationally-oriented assessments and 

17 validations of commercial emergency responder equip18 ment and systems, including hand-held detectors for 

19 agents used in weapons of mass destruction; 

20 ‘‘(2) is supported by a network of scientists who 

21 perform the assessment and validation activities; 

22 ‘‘(3) provides results along with other relevant 

23 equipment information to the emergency response 

24 provider community in an operationally useful form; 


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1 ‘‘(4) provides information on equipment that 

2 falls within the categories listed in the Department’s 

3 authorized equipment list; 

4 ‘‘(5) provides information that enables decision5 makers and responders to better select, procure, use 

6 and maintain emergency responder equipment; and 

7 ‘‘(6) shares such information nationally with the 

8 emergency response provider community. 

9 ‘‘SEC. 2135. PAYMENT FOR BIOTERRORISM LABORATORY 

10 SERVICES. 

11 ‘‘In carrying out their functions, responsibilities, au12 thorities, and duties to counter biological terrorism, the Sec13 retary, the Attorney General, and the heads of other partici14 pating Federal agencies are authorized to enter into con15 tracts with the State and local public health laboratories 

16 that compose the Laboratory Response Network for Bioter17 rorism, and any other qualified laboratories, for the provi18 sion of laboratory testing services on a fee-for-service basis 

19 or on a prepayment or other similar basis. 

20 ‘‘SEC. 2136. ESTABLISHMENT OF THE INTEGRATED CONSOR21 TIUM OF LABORATORY NETWORKS. 

22 ‘‘(a) ESTABLISHMENT.—There is established in the De23 partment an Integrated Consortium of Laboratory Net24 works that is managed by the Secretary. 


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1 ‘‘(b) REQUIREMENTS.—The Integrated Consortium of 

2 Laboratory Networks shall— 

3 ‘‘(1) be composed of networks of laboratories ca4 pable of integrated and coordinated response to and 

5 consequence management of attacks from weapons of 

6 mass destruction, acts of terrorism, and other inci7 dents requiring laboratory response capabilities; 

8 ‘‘(2) be a coordinated and operational system of 

9 laboratory networks that provide timely, high quality 

10 results for early detection and effective consequence 

11 management of attacks from weapons of mass destruc12 tion, acts of terrorism, and other events requiring an 

13 integrated laboratory response; 

14 ‘‘(3) serve as a system of laboratory networks 

15 that are equipped to detect and respond quickly to at16 tacks from weapons of mass destruction and acts of 

17 terrorism; 

18 ‘‘(4) provide limited containment and analysis 

19 in support of the Department, the Federal Bureau of 

20 Investigation, and other law enforcement agencies 

21 with responsibilities for investigating incidents in22 volving weapons of mass destruction or their agents; 

23 and 

24 ‘‘(5) support threat agent characterization stud25 ies and assay evaluation, research and development. 


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1 ‘‘Subtitle D—Attribution 

2 ‘‘SEC. 2141. BIOFORENSICS CAPABILITIES AND STRATEGY. 

3 ‘‘(a) NATIONAL BIOFORENSICS ANALYSIS CENTER.— 

4 There is established in the Department a National 

5 Bioforensics Analysis Center which shall serve as the lead 

6 Federal facility to— 

7 ‘‘(1) provide definitive forensic examination of 

8 biothreat agents and related evidence; 

9 ‘‘(2) provide necessary biocontainment; 

10 ‘‘(3) integrate bioforensics requirements for law 

11 enforcement, national security, and homeland secu12 rity; 

13 ‘‘(4) provide bioforensics analysis in support of 

14 the executive agencies with primary responsibilities 

15 for preventing, deterring, responding to, attributing, 

16 and recovering from biological attacks; 

17 ‘‘(5) develop national bioforensics standards; 

18 ‘‘(6) maintain the national bioforensics reposi19 tory collection as a reference collection of biological 

20 agents and toxins for bioforensics comparisons and 

21 identifications; and 

22 ‘‘(7) support threat agent characterization stud23 ies and bioforensics assay evaluation research and de24 velopment. 


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1 ‘‘(b) NATIONAL BIOFORENSICS REPOSITORY COLLEC2 TION.— 

3 ‘‘(1) IN GENERAL.—The National Bioforensics 

4 Analysis Center shall maintain a distributed national 

5 bioforensics repository collection. 

6 ‘‘(2) ACTIVITIES.—The national bioforensics re7 pository collection shall— 

8 ‘‘(A) receive, store, and distribute biological 

9 threat agents and toxins; 

10 ‘‘(B) serve as a distributed reference collec11 tion for comparative bioforensics identifications 

12 and characterizations; and 

13 ‘‘(C) support threat agent characterization 

14 studies and the development of bioforensics as15 says, genomic analyses, organic and inorganic 

16 chemical analyses, electron microscopy analyses, 

17 and other relevant assays, analyses, and tests. 

18 ‘‘(3) PARTICIPATION.— 

19 ‘‘(A) IN GENERAL.—The Secretary, the At20 torney General, the Secretary of Agriculture, the 

21 Secretary of Defense, the Secretary of Energy, 

22 the Secretary of Health and Human Services, the 

23 Director of National Intelligence, and the head of 

24 any other appropriate executive agency with a 

25 biological agent or toxin collection that is useful 


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1 for the bioforensics analysis of biological attacks, 

2 performance of biological threat agent identifica3 tion and characterization studies, or evaluation 

4 and development of bioforensics assays and meth5 ods shall provide to the distributed national 

6 bioforensics repository collection authenticated 

7 replicate samples of, or information on, all rel8 evant biological strains and toxins, as deter9 mined by the Secretary, in consultation with the 

10 head of the executive agency possessing the agent 

11 or toxin. 

12 ‘‘(B) OTHER BIOLOGICAL AGENTS AND TOX13 INS.—The Secretary shall require the contribu14 tion to the national bioforensics repository collec15 tion of authenticated replicate samples of, or in16 formation on, all relevant biological strains and 

17 toxins, as determined by the Secretary, from 

18 public and private biological agent and toxin 

19 collections that were collected or created with 

20 support from a Federal grant or contract and 

21 that support the functions described in para22 graph (2). 

23 ‘‘(4) ACCESS.—The Secretary shall— 

24 ‘‘(A) provide any executive agency that sub25 mits a biological agent or toxin, or information 


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1 on a biological agent or toxin, to the national 

2 bioforensics repository collection with access to 

3 the collection; and 

4 ‘‘(B) establish a mechanism to provide pub5 lic and private entities with access to agents or 

6 toxins in, or information regarding, the national 

7 bioforensics repository collection, as determined 

8 appropriate by the Secretary, with appropriate 

9 protection of classified or law enforcement sen10 sitive information and intellectual property 

11 rights. 

12 ‘‘(5) REPORT.— 

13 ‘‘(A) IN GENERAL.—Not later than one year 

14 after the date of the enactment of this section, 

15 and annually thereafter, the Secretary, in con16 sultation with the Attorney General, the Sec17 retary of Agriculture, the Secretary of Defense, 

18 the Secretary of Energy, the Secretary of Health 

19 and Human Services, the Director of National 

20 Intelligence, and the head of any other appro21 priate executive agency that participates in or 

22 contributes agents, or toxins, or information to 

23 the national bioforensics repository collection, 

24 shall submit to the appropriate committees of 


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1 Congress a report regarding the national 

2 bioforensics repository collection. 

3 ‘‘(B) CONTENTS.—The report submitted 

4 under subparagraph (A) shall— 

5 ‘‘(i) discuss the status of the establish6 ment of the distributed national bioforensics 

7 repository collection; 

8 ‘‘(ii) identify domestic and inter9 national biological agent and toxin collec10 tions that would prove useful in carrying 

11 out the functions of the distributed national 

12 bioforensics repository collection; 

13 ‘‘(iii) examine any access or participa14 tion issues affecting the establishment of the 

15 distributed national bioforensics repository 

16 collection or the ability to support 

17 bioforensics analysis, threat agent charac18 terization studies, or bioforensics assay eval19 uation, research, and development, includ20 ing— 

21 ‘‘(I) intellectual property con22 cerns; 

23 ‘‘(II) access to collected or created 

24 biological agent or toxin collections 

25 funded by a Federal grant or contract; 


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1 ‘‘(III) costs incurred by domestic 

2 and international biological agent and 

3 toxin collections to access or contribute 

4 biological agents or toxins to the na5 tional bioforensics repository collection; 

6 and 

7 ‘‘(IV) access to the national 

8 bioforensics repository collection by 

9 public and private researchers to sup10 port threat agent characterization 

11 studies, bioforensics assay evaluation, 

12 research, and development, and bio13 security research and development; and 

14 ‘‘(iv) other issues determined appro15 priate. 

16 ‘‘(c) NATIONAL BIOFORENSICS STRATEGY.— 

17 ‘‘(1) IN GENERAL.—The Secretary, in coordina18 tion with the Attorney General, the Secretary of Agri19 culture, the Secretary of Defense, the Secretary of 

20 Health and Human Services, the Director of National 

21 Intelligence, and the head of any other appropriate 

22 executive agency, as determined by the Secretary, 

23 shall develop, coordinate, and maintain a national 

24 bioforensics strategy. 


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1 ‘‘(2) CONTENTS.—The national bioforensics 

2 strategy shall— 

3 ‘‘(A) provide for a coordinated approach 

4 across all executive agencies with responsibilities 

5 for— 

6 ‘‘(i) conducting bioforensics examina7 tion of biological threat agents and related 

8 evidence; and 

9 ‘‘(ii) generating bioforensics require10 ments for law enforcement, national secu11 rity, and homeland security; 

12 ‘‘(B) describe the roles and responsibilities 

13 of all relevant executive agencies, including— 

14 ‘‘(i) research to characterize threat 

15 agents; 

16 ‘‘(ii) assay evaluation, research, and 

17 development; and 

18 ‘‘(iii) funding; 

19 ‘‘(C) establish mechanisms, in coordination 

20 with State, local, and tribal authorities, for co21 ordinating with public health, homeland secu22 rity, and law enforcement agencies for the collec23 tion or receipt, transfer, or submission of 

24 bioforensics evidence for analysis and its use; 

25 and 


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1 ‘‘(D) include— 

2 ‘‘(i) guidance for collecting, processing, 

3 and analyzing samples; 

4 ‘‘(ii) requirements for reporting 

5 bioforensics information to appropriate 

6 agencies; and 

7 ‘‘(iii) requirements for the distributed 

8 national bioforensics repository collection. 

9 ‘‘(3) REPORT.—Not later than one year after the 

10 date of the enactment of this section, and biennially 

11 thereafter, the Secretary, in consultation with the At12 torney General, the Secretary of Agriculture, the Sec13 retary of Defense, the Secretary of Health and 

14 Human Services, the Director of National Intel15 ligence, and the heads of other appropriate agencies, 

16 as determined by the Secretary, shall submit to the 

17 appropriate committees of Congress the national 

18 bioforensics strategy. 

19 ‘‘(d) CONCEPT OF OPERATIONS.—The Secretary, in co20 ordination with the Attorney General and the heads of any 

21 other appropriate Federal agencies shall ensure the avail22 ability of a detailed concept of operations for information 

23 sharing and all-source analysis to support timely attribu24 tion of biological attacks. 


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1 ‘‘(e) DETAILEE PROGRAM.—Subject to the availability 

2 of appropriations, the Secretary may implement a detailee 

3 program to detail from governmental entities national bio4 security and biodefense stakeholders with appropriate clear5 ances, on a reimbursable basis, to the National Bioforensics 

6 Analysis Center for the purpose of— 

7 ‘‘(1) providing training and other educational 

8 benefits for such stakeholders to help them to better 

9 understand the policies, procedures, and laws gov10 erning national bioforensics activities; and 

11 ‘‘(2) bolstering the capabilities and information 

12 sharing activities of the National Bioforensics Anal13 ysis Center with national biosecurity and biodefense 

14 stakeholders. 

15 ‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary, 

16 in coordination with the Attorney General and the heads 

17 of any other appropriate Federal agencies, shall establish 

18 a national-level research and development strategy and im19 plementation plan to advance the field of bioforensics. 

20 ‘‘(g) DEFINITION OF BIOFORENSICS.—In this section, 

21 the term ‘bioforensics’ means the scientific discipline dedi22 cated to analyzing evidence from an attack with a biological 

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1 vertent release of a biological agent or toxin for attribution 

2 purposes. 

3 ‘‘SEC. 2142. FEDERAL LAW ENFORCEMENT TRAINING TO IN4 VESTIGATE BIOLOGICAL THREATS. 

5 ‘‘The Secretary, in coordination with the Attorney 

6 General, the Secretary of Agriculture, the Secretary of 

7 Health and Human Services, and the heads of other appro8 priate Federal departments and agencies, shall make avail9 able to law enforcement, public health, and security per10 sonnel at the Federal Law Enforcement Training Center 

11 training on recognizing and responding to situations in12 volving potential biological threats, including performing 

13 joint criminal and epidemiological investigations, and 

14 shall— 

15 ‘‘(1) ensure that tailored tactics, techniques, and 

16 procedures are made available to law enforcement and 

17 security personnel, including access to the tools needed 

18 to respond to biological threats; 

19 ‘‘(2) promote the use of simulation among Fed20 eral partners to exercise capabilities, refine oper21 ational concepts, and strengthen relationships across 

22 the Government; and 

23 ‘‘(3) make training available that will ensure 

24 that law enforcement, public health, and agricultural 

25 investigations of biological threats are coordinated. 


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1 ‘‘Subtitle E—Response 

2 ‘‘SEC. 2151. FIRST RESPONDER GUIDANCE CONCERNING 

3 WEAPONS OF MASS DESTRUCTION ATTACKS. 

4 ‘‘(a) ESTABLISHMENT OF VOLUNTARY GUIDANCE.— 

5 Not later than one year after the date of the enactment of 

6 this section, the Secretary shall— 

7 ‘‘(1) develop for police, fire, emergency medical 

8 services, emergency management, and public health 

9 personnel, voluntary guidance for responding to a re10 lease of chemical, biological, radiological, or nuclear 

11 material; 

12 ‘‘(2) in developing the guidance under paragraph 

13 (1), review the experiences of other countries and the 

14 expertise of academic institutions and non-govern15 mental organizations; and 

16 ‘‘(3) make such guidance available to State, 

17 local, and tribal authorities, nongovernmental organi18 zations, the private sector, and the public. 

19 ‘‘(b) CONTENTS.—The guidance developed under sub20 section (a)(1) shall include— 

21 ‘‘(1) protective action guidance for ensuring the 

22 security, health, and safety of emergency response 

23 providers; 


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1 ‘‘(2) specific information regarding the effects of 

2 the chemical, biological, radiological, or nuclear mate3 rial on those exposed to the agent; and 

4 ‘‘(3) best practices for emergency response pro5 viders to effectively deal with individuals affected by 

6 an incident involving chemical, biological, radio7 logical, or nuclear material. 

8 ‘‘(c) REVIEW AND REVISION OF GUIDANCE.—The Sec9 retary shall— 

10 ‘‘(1) review the guidance developed under sub11 section (a)(1) at least once every 2 years, 

12 ‘‘(2) make revisions to the guidance as appro13 priate; and 

14 ‘‘(3) make any revised guidance available to 

15 State, local, and tribal authorities, nongovernmental 

16 organizations, the private sector, and the public. 

17 ‘‘(d) PROCEDURES FOR DEVELOPING AND REVISING

18 GUIDANCE.—In carrying out the requirements of this sec19 tion, the Secretary shall establish procedures to— 

20 ‘‘(1) inventory existing relevant hazardous mate21 rial response guidance; 

22 ‘‘(2) enable members of the first responder and 

23 first provider community to submit recommendations 

24 of areas in which guidance is needed and could be de25 veloped under subsection (a)(1); 


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1 ‘‘(3) determine which entities should be consulted 

2 in developing or revising the guidance; 

3 ‘‘(4) prioritize, on a regular basis, guidance that 

4 should be developed or revised; and 

5 ‘‘(5) develop and disseminate the guidance in ac6 cordance with the prioritization under paragraph (4). 

7 ‘‘(e) CONSULTATIONS.—The Secretary shall develop 

8 and revise the guidance developed under subsection (a)(1), 

9 and the procedures required under subsection (d), in con10 sultation with— 

11 ‘‘(1) the heads of other Federal departments and 

12 agencies, as appropriate; 

13 ‘‘(2) the National Advisory Council established 

14 under section 508; 

15 ‘‘(3) the National Domestic Preparedness Consor16 tium; 

17 ‘‘(4) State, local, and tribal authorities; and 

18 ‘‘(5) nongovernmental organizations and private 

19 industry. 

20 ‘‘(f) REPORTING REQUIREMENTS.—Not later than 18 

21 months after the date of the enactment of this section and 

22 annually thereafter, the Secretary shall submit to the ap23 propriate congressional committees— 

24 ‘‘(1) a description of the procedures established 

25 under subsection (d); 


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1 ‘‘(2) any guidance in effect on the date of the re2 port; 

3 ‘‘(3) a list of entities to which the guidance de4 scribed in paragraph (2) was disseminated; 

5 ‘‘(4) a plan for reviewing the guidance described 

6 in paragraph (2), in accordance with subsection (e); 

7 ‘‘(5) guidance required under subsection (d)(4), 

8 and the methodology used by the Secretary for such 

9 prioritization; and 

10 ‘‘(6) a plan for developing, revising, and dis11 seminating the guidance. 

12 ‘‘SEC. 2152. INTEGRATED PLUME MODELING FOR COLLEC13 TIVE RESPONSE. 

14 ‘‘(a) DEVELOPMENT.— 

15 ‘‘(1) IN GENERAL.—The Secretary shall acquire, 

16 use, and disseminate integrated plume models to en17 able rapid response activities following a chemical, 

18 biological, nuclear, or radiological attack or event. 

19 ‘‘(2) SCOPE.—The Secretary shall— 

20 ‘‘(A) ensure the rapid development and dis21 tribution of integrated plume models to appro22 priate officials of the Federal Government and 

23 State, local, and tribal authorities to enable im24 mediate response to a chemical, biological, or ra25 diological attack or event; 


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1 ‘‘(B) establish mechanisms for dissemina2 tion by appropriate emergency response officials 

3 of the integrated plume models described in 

4 paragraph (1) to nongovernmental organizations 

5 and the public to enable appropriate collective 

6 response activities; 

7 ‘‘(C) ensure that the development and dis8 semination of integrated plume models are as9 sessed during exercises administered by the De10 partment; and 

11 ‘‘(D) ensure that lessons learned from as12 sessing the development and dissemination of in13 tegrated plume models during exercises adminis14 tered by the Department are put into the De15 partment of Homeland Security Lessons Learned 

16 Information Sharing system. 

17 ‘‘(b) REPORT.—Not later than one year after the date 

18 of enactment of this section, and annually thereafter, the 

19 Secretary shall submit to the appropriate congressional 

20 committees a report regarding— 

21 ‘‘(1) the acquisition, use, and dissemination of 

22 integrated plume models under this section; 

23 ‘‘(2) lessons learned from assessing the develop24 ment and dissemination of integrated plume models 

25 during exercises administered by the Department; and 


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1 ‘‘(3) recommendations for improving integrated 

2 plume models, as appropriate. 

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

4 ‘‘(1) The term ‘plume model’ means the assess5 ment of the location and prediction of the spread of 

6 agents following a chemical, biological, radiological, 

7 or nuclear attack or event. 

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

9 plume model that integrates protective action guid10 ance and other information as the Secretary deter11 mines appropriate. 

12 ‘‘Subtitle F—Recovery 

13 ‘‘SEC. 2161. RECOVERY AND RESTORATION FROM A BIO14 LOGICAL ATTACK OR INCIDENT GUIDANCE. 

15 ‘‘(a) ESTABLISHMENT OF GUIDANCE.—Not later than 

16 one year after the date of the enactment of this section, the 

17 Secretary, in coordination with the Administrator of the 

18 Environmental Protection Agency and in consultation with 

19 the Director of the Occupational Safety and Health Agency, 

20 and the Director of the National Institute for Occupational 

21 Safety and Health, shall develop and issue guidance for 

22 clean-up and restoration of indoor and outdoor areas, in23 cluding subways and other mass transportation facilities, 

24 that have been affected by a biological attack or event. 


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1 ‘‘(b) CONTENTS.—The guidance developed under sub2 section (a) shall include— 

3 ‘‘(1) acceptable levels of growth of the organism 

4 in post-remediation area samples from affected sites; 

5 ‘‘(2) standards for effective clean-up of affected 

6 sites; 

7 ‘‘(3) standards for safe post-event occupancy of 

8 affected sites; 

9 ‘‘(4) requirements to ensure that the decon10 tamination procedures for responding organizations 

11 do not conflict; 

12 ‘‘(5) requirements that each responding organi13 zation uses a uniform system for tracking costs and 

14 performance of clean-up contractors; 

15 ‘‘(6) levels of personal protection equipment; 

16 ‘‘(7) maintenance of negative air pressure in 

17 buildings; 

18 ‘‘(8) standards for proper selection and use of 

19 personal protective equipment; 

20 ‘‘(9) air sampling procedures; and 

21 ‘‘(10) how to develop occupational health and 

22 safety plans that are appropriate for the specific risk 

23 to responder health. 

24 ‘‘(c) REVIEW AND REVISION OF GUIDANCE.—The Sec25 retary shall— 


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1 ‘‘(1) not less frequently than once every 2 years, 

2 review the guidance developed under subsection (a); 

3 ‘‘(2) make revisions to the guidance as appro4 priate; and 

5 ‘‘(3) make the revised guidance available to the 

6 Federal government, State, local, and tribal authori7 ties, nongovernmental organizations, the private sec8 tor, and the public. 

9 ‘‘(d) PROCEDURES FOR DEVELOPING AND REVISING

10 GUIDANCE.—In carrying out the requirements of this sec11 tion, the Secretary shall establish procedures to— 

12 ‘‘(1) inventory existing relevant guidance; 

13 ‘‘(2) enable the public to submit recommenda14 tions of areas in which guidance is needed; 

15 ‘‘(3) determine which entities should be consulted 

16 in developing or revising the guidance; 

17 ‘‘(4) prioritize, on a regular basis, guidance that 

18 should be developed or revised; and 

19 ‘‘(5) develop and disseminate the guidance in ac20 cordance with the prioritization under paragraph (4). 

21 ‘‘(e) CONSULTATIONS.—The Secretary shall develop 

22 and revise the guidance developed under subsection (a), and 

23 the procedures required under subsection (d), in consulta24 tion with— 


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1 ‘‘(1) the heads of other Federal departments and 

2 agencies, as appropriate; 

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

4 ‘‘(3) nongovernmental organizations and private 

5 industry. 

6 ‘‘(f) REPORT.—Not later than one year after the date 

7 of the enactment of this section, and annually thereafter, 

8 the Secretary shall provide appropriate congressional com9 mittees with— 

10 ‘‘(1) a description of the procedures established 

11 under subsection (d); 

12 ‘‘(2) any guidance in effect on the date of the re13 port; 

14 ‘‘(3) a list of entities to which the guidance de15 scribed in paragraph (2) were disseminated; 

16 ‘‘(4) a plan for reviewing the guidance described 

17 in paragraph (2), in accordance with subsection (e); 

18 ‘‘(5) the prioritized list of the guidance required 

19 under subsection (d)(4), and the methodology used by 

20 the Secretary for such prioritization; and 

21 ‘‘(6) a plan for developing, revising, and dis22 seminating the guidance.’’. 

23 (b) CLERICAL AMENDMENTS.—The table of contents in 

24 section 1(b) of such Act is amended by adding at the end 

25 the following new items: 


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‘‘TITLE XXI—WEAPONS OF MASS DESTRUCTION PREVENTION AND 

PREPAREDNESS 

‘‘Subtitle A—Prevention and Deterrence 

‘‘Sec. 2101. Weapons of Mass Destruction Intelligence and Information 

Sharing Unit. 

‘‘Sec. 2102. Information sharing and collaboration for biosecurity and biodefense. 

‘‘Sec. 2103. Bioterrorism risk assessments. 

‘‘Sec. 2104. Radiological materials security. 

‘‘Sec. 2105. Enhanced biosecurity measures. 

‘‘Sec. 2106. Tier I Material Threat Agent locations. 

‘‘Sec. 2107. High containment biological laboratory security grants. 

‘‘Sec. 2108. Laboratory biosecurity information sharing. 

‘‘Sec. 2109. Periodic homeland security review of criminal statutes. 

‘‘Sec. 2110. Export enforcement for counter-proliferation. 

‘‘Subtitle B—Preparedness 

‘‘Sec. 2121. Communication of threat information and alerts. 

‘‘Sec. 2122. Individual and community preparedness for weapons of mass 

destruction. 

‘‘Subtitle C—Detection 

‘‘Sec. 2131. National biosurveillance strategy. 

‘‘Sec. 2132. Detection of biological attacks. 

‘‘Sec. 2133. Rapid biological threat detection and identification. 

‘‘Sec. 2134. Establishment of the system assessment and validation for emergency responders (SAVER) program. 

‘‘Sec. 2135. Payment for bioterrorism laboratory services. 

‘‘Sec. 2136. Establishment of the integrated consortium of laboratory networks. 

‘‘Subtitle D—Attribution 

‘‘Sec. 2141. Bioforensics capabilities and strategy. 

‘‘Sec. 2142. Federal law enforcement training to investigate biological 

threats. 

‘‘Subtitle E—Response 

‘‘Sec. 2151. First responder guidance concerning weapons of mass destruction attacks. 

‘‘Sec. 2152. Integrated plume modeling for collective response. 

‘‘Subtitle F—Recovery 

‘‘Sec. 2161. Recovery and restoration from a biological attack or incident 

guidance. 


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1 SEC. 202. DEFINITIONS. 

2 Section 2 of the Homeland Security Act of 2002 (6 

3 U.S.C. 101) is amended by adding at the end the following 

4 new paragraphs: 

5 ‘‘(19) The term ‘weapon of mass destruction’ has 

6 the meaning given that term in section 1403(1) fo the 

7 Defense Against Weapons of Mass Destruction Act of 

8 1996 (50 U.S.C. 2302). 

9 ‘‘(20) The term ‘Intelligence Community’ has the 

10 meaning given that term in section 3(4) of the Na11 tional Security Act of 1947 (50 U.S.C. 401a(4)). 

12 ‘‘(21) The term ‘national biosecurity and bio13 defense stakeholders’ means officials from the Federal, 

14 State, local, and tribal authorities and individuals 

15 from the private sector who are involved in efforts to 

16 prevent, deter, prepare for, detect, attribute, respond, 

17 and recover from a biological attack or other phe18 nomena that may have serious health consequences for 

19 the United States, including wide-scale fatalities or 

20 infectious disease outbreaks. 

21 ‘‘(22) The term ‘Tier I Material Threat Agent’ 

22 means a substance so designated under section 

23 351A(a)(2) of the Public Health Service Act or section 

24 212(a)(2) of the Agricultural Bioterrorism Protection 

25 Act of 2002.’’. 


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1 SEC. 203. DUAL-USE TERRORIST RISKS FROM SYNTHETIC 

2 GENOMICS. 

3 (a) SENSE OF CONGRESS.—It is the sense of Congress 

4 that the field of synthetic genomics has the potential to fa5 cilitate enormous gains in fundamental discovery and bio6 technological applications, but it also has inherent dual7 use homeland security risks that must be managed. 

8 (b) REQUIREMENT.—Not later than one year after the 

9 date of enactment of this Act, the Secretary of Homeland 

10 Security, acting through the Under Secretary of Homeland 

11 Security for Science and Technology, shall examine and re12 port to the appropriate congressional committees on the 

13 homeland security implications of the dual-use nature of 

14 synthetic genomics, and if the Under Secretary determines 

15 that such research is appropriate, may conduct research in 

16 that area, including— 

17 (1) determining the current capability of syn18 thetic nucleic acid providers to effectively differentiate 

19 a legitimate customer from a potential terrorist or 

20 other malicious actor; 

21 (2) determining the current capability of syn22 thetic nucleic acid providers to effectively screen or23 ders for sequences of homeland security concern; and 

24 (3) making recommendations regarding screen25 ing software, protocols, and other remaining capa26 bility gaps uncovered by the study. 


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1 SEC. 204. DISSEMINATION OF INFORMATION ANALYZED BY 

2 THE DEPARTMENT TO STATE, LOCAL, TRIBAL, 

3 AND PRIVATE ENTITIES WITH RESPONSIBIL4 ITIES RELATING TO HOMELAND SECURITY. 

5 (a) RESPONSIBILITIES OF THE SECRETARY.—Section 

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

7 121(d)(8)) is amended by striking ‘‘and to agencies of 

8 State’’ and all that follows and inserting ‘‘to State, local, 

9 tribal, and private entities with such responsibilities, and, 

10 as appropriate, to the public, in order to assist in pre11 venting, deterring, or responding to acts of terrorism 

12 against the United States.’’. 

13 (b) REPORT.—Not later than one year after the date 

14 of the enactment of this Act, the Secretary of Homeland Se15 curity shall submit to the appropriate congressional com16 mittees a report on the implementation of this section. 

17 SEC. 205. NATIONAL BIOSURVEILLANCE INTEGRATION CEN18 TER (NBIC). 

19 Section 316 of the Homeland Security Act of 2002 (6 

20 U.S.C. 195b) is amended— 

21 (1) in subsection (a), by striking ‘‘an office or 

22 directorate of the Department’’ and all that follows 

23 through the period at the end and inserting the fol24 lowing: ‘‘the Office of Intelligence and Analysis.’’; 

25 (2) in subsection (d)(2)(B)— 


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1 (A) by inserting ‘‘and disseminate’’ after 

2 ‘‘integrate’’; and 

3 (B) by inserting ‘‘, including information 

4 and intelligence generated elsewhere within the 

5 Office of Intelligence and Analysis and the De6 partment,’’ after ‘‘information’’ ; 

7 (3) in subsection (e)(1), by striking subpara8 graph (A) and inserting the following new subpara9 graph (A): 

10 ‘‘(A) integrate biosurveillance information 

11 into the NBIC, with the goal of promoting infor12 mation sharing between Federal, State, local, 

13 and tribal authorities to detect biological attacks 

14 and events of homeland concern;’’; 

15 (4) by amending paragraph (2) of subsection (f) 

16 to read as follows: 

17 ‘‘(2) DETAIL OF PERSONNEL.—The head of a 

18 participating Federal department or agency shall de19 tail, on a reimbursable basis, any of the personnel of 

20 that department or agency to the Department to as21 sist the NBIC in carrying out this section.’’; and 

22 (5) by redesignating subsection (j) as subsection 

23 (k) and inserting after subsection (i) the following 

24 new subsection (j): 


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1 ‘‘(j) ANNUAL REPORT.—Not later than one year after 

2 the date of the enactment of the WMD Prevention and Pre3 paredness Act of 2010 and annually thereafter, the Sec4 retary shall submit to the appropriate congressional com5 mittees a report on— 

6 ‘‘(1) the status of operations at the National Bio7 surveillance Integration Center of the Department 

8 under section 316; 

9 ‘‘(2) efforts by the Office of Intelligence and 

10 Analysis to take responsibility for the National Bio11 surveillance Integration Center; and 

12 ‘‘(3) efforts to integrate the biosurveillance efforts 

13 of Federal, State, local, and tribal authorities.’’. 

14 SEC. 206. REPORT ON ESTABLISHMENT OF THE SYSTEM AS15 SESSMENT AND VALIDATION FOR EMER16 GENCY RESPONDERS (SAVER) PROGRAM. 

17 Not later than one year after the date of the enactment 

18 of this Act, the Secretary of Homeland Security shall sub19 mit to the appropriate congressional committees a report 

20 on the SAVER Program under section 2134 of the Home21 land Security Act of 2002, as added by section 201. 

22 SEC. 207. NATIONAL ACADEMY OF SCIENCES STUDY OF FO23 RENSIC SCIENCE IN HOMELAND SECURITY. 

24 (a) STUDY.—Not later than 90 days after the date of 

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1 rity, acting through the Under Secretary of Homeland Se2 curity for Science and Technology, shall seek to enter into 

3 an agreement with the National Academy of Sciences to— 

4 (1) conduct a study, building on previous studies 

5 conducted by the National Academy of Sciences, on 

6 the role of forensic science in homeland security; and 

7 (2) issue recommendations to enhance this home8 land security capability to investigate attacks from 

9 weapons of mass destruction, terrorist incidents, and 

10 other crimes investigated by the Department. 

11 (b) REPORT.—Not later than two years after the date 

12 of the enactment of this Act, the Secretary shall submit to 

13 the appropriate congressional committees a report con14 taining the results of the National Academy of Sciences 

15 study required under subsection (a), together with any rec16 ommendations of the Secretary related thereto. 

17 (c) AUTHORIZATION OF APPROPRIATIONS.—There is 

18 authorized to be appropriated to the Department, for fiscal 

19 year 2011, $1,000,000 to carry out this section. 

20 SEC. 208. HARMONIZATION OF REGULATIONS. 

21 (a) REGULATIONS UNDER PUBLIC HEALTH SERVICE

22 ACT.—Not later than one year after the Secretary of Home23 land Security promulgates regulations or amendments 

24 thereto to carry out section 2104 of the Homeland Security 

25 Act of 2002, as added by section 201, the Secretary of 


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1 Health and Human Services shall amend regulations pro2 mulgated under the Select Agent Program under section 

3 351A(b)(1) of the Public Health Service Act (42 U.S.C. 

4 262a(b)(1)) to ensure that such regulations are not redun5 dant or are not in conflict with the regulations promulgated 

6 by the Secretary under such section 2104. 

7 (b) REGULATIONS UNDER AGRICULTURE BIOTER8 RORISM PROTECTION ACT OF 2002.—Not later than one 

9 year after the Secretary of Homeland Security promulgates 

10 regulations or amendments thereto pursuant to such section 

11 2104, the Secretary of Agriculture shall amend regulations 

12 promulgated under the Select Agent Program under section 

13 212(b)(1) of the Agricultural Bioterrorism Protection Act 

14 of 2002 (7 U.S.C. 8401(b)(1)) to ensure that such regula15 tions are not redundant or are not in conflict with the regu16 lations promulgated by the Secretary under such section 

17 2104. 

18 SEC. 209. COMMUNICATIONS PLANNING FOR WEAPONS OF 

19 MASS DESTRUCTION INFORMATION DISSEMI20 NATION. 

21 (a) COMMUNICATIONS PLANS REQUIRED.—Section 

22 653 of the Post-Katrina Emergency Management Reform 

23 Act of 2006 (6 U.S.C. 753) is amended— 


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1 (1) in subsection (a)(4), by inserting after ‘‘man2 made disasters’’ the following ‘‘, and a communica3 tions plan described in subsection (f)’’; and 

4 (2) by adding at the end the following new sub5 section: 

6 ‘‘(f) COMMUNICATIONS PLAN.— 

7 ‘‘(1) IN GENERAL.—A communications plan de8 veloped under subsection (a)(4) shall be designed to 

9 provide information to the public related to pre10 venting, preparing for, and responding to attacks 

11 from weapons of mass destruction and acts of ter12 rorism; 

13 ‘‘(2) CONSULTATION.—As appropriate, the Ad14 ministrator shall consult with State, local, and tribal 

15 authorities and coordinate with other Federal depart16 ments and agencies in developing communications 

17 plans under paragraph (1). 

18 ‘‘(3) PRE-SCRIPTED MESSAGES AND MESSAGE

19 TEMPLATES.— 

20 ‘‘(A) IN GENERAL.—The Administrator 

21 shall develop and disseminate pre-scripted mes22 sages and message templates to be provided to 

23 State, local, and tribal authorities so that those 

24 authorities can quickly and rapidly disseminate 

25 critical information to the public in anticipation 


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1 of, during, or in the immediate aftermath of an 

2 attack from a weapon of mass destruction or ter3 rorist incident, and to be included in the Depart4 ment of Homeland Security’s Lessons Learned 

5 Information Sharing system. 

6 ‘‘(B) DEVELOPMENT AND DESIGN.—The 

7 pre-scripted messages or message templates 

8 shall— 

9 ‘‘(i) be developed in consultation with 

10 State, local, and tribal authorities and in 

11 coordination with other appropriate Federal 

12 departments and agencies; 

13 ‘‘(ii) be designed to provide accurate, 

14 essential, and appropriate information and 

15 instructions to the population directly af16 fected by an incident, including informa17 tion regarding an evacuation, sheltering in 

18 place, hospital surge operations, health, and 

19 safety; and 

20 ‘‘(iii) be designed to provide accurate, 

21 essential, and appropriate information and 

22 instructions to emergency response pro23 viders and medical personnel responding to 

24 an incident. 


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1 ‘‘(C) COMMUNICATIONS FORMATS.—The Ad2 ministrator shall develop pre-scripted messages 

3 or message templates under this paragraph in 

4 multiple formats to ensure delivery— 

5 ‘‘(i) in cases where the usual commu6 nications infrastructure is unusable; and 

7 ‘‘(ii) to individuals with disabilities or 

8 other special needs and individuals with 

9 limited English proficiency. 

10 ‘‘(D) DISSEMINATION AND TECHNICAL AS11 SISTANCE.—The Administrator shall ensure that 

12 all pre-scripted messages and message templates 

13 developed under this paragraph are made avail14 able to State, local, and tribal authorities so that 

15 those authorities may incorporate them, as ap16 propriate, into their emergency plans. The Ad17 ministrator shall also make available relevant 

18 technical assistance to those authorities to sup19 port communications planning. 

20 ‘‘(E) EXERCISES.—To ensure that the pre21 scripted messages or message templates developed 

22 under this paragraph can be effectively utilized 

23 in a disaster or incident, the Administrator shall 

24 incorporate such pre-scripted messages or mes25 sage templates into exercises conducted under the 


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1 National Exercise Program described in section 

2 648 of the Post-Katrina Emergency Management 

3 Reform Act of 2006 (6 U.S.C. 748).’’. 

4 (b) REPORT.—Not later than one year after the date 

5 of the enactment of this Act, the Administrator shall submit 

6 to the appropriate congressional committees the commu7 nications plans required to be developed under the amend8 ments made by subsection (a), including pre-scripted mes9 sages or message templates developed in conjunction with 

10 the plans and a description of the means that will be used 

11 to deliver these messages during such incidents. 

12 SEC. 210. ENVIRONMENTAL RECOVERY FROM CHEMICAL, BI13 OLOGICAL, RADIOLOGICAL, AND NUCLEAR 

14 ATTACKS. 

15 (a) IN GENERAL.—To facilitate environmental recov16 ery from a chemical, biological, radiological, or nuclear at17 tack or other incident involving chemical, biological, radio18 logical, or nuclear materials and to foster collective response 

19 to terrorism, the Administrator of the Environmental Pro20 tection Agency, in coordination with the Administrator of 

21 the Federal Emergency Management Agency, shall assess 

22 capability gaps in environmental recovery preparedness 

23 and provide guidance to State, local, and tribal authorities. 


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1 (b) REQUIREMENTS.—In carrying out subsection (a), 

2 the Administrator of the Environmental Protection Agency 

3 shall— 

4 (1) assess capability gaps in the Nation’s ability 

5 to recover from chemical, biological, radiological, and 

6 nuclear attacks or incidents, with specific attention 

7 to— 

8 (A) decontamination standards, gaps in 

9 such standards, and recommendations for re10 search to minimize these gaps; 

11 (B) environmental remediation methods; 

12 and 

13 (C) such other components as determined by 

14 the Secretary; 

15 (2) disseminate guidance to State, local, and 

16 tribal authorities that conforms to the goals of the Na17 tional Disaster Recovery Strategy as required in Sec18 tion 682 of the Department of Homeland Security 

19 Appropriations Act, 2007 (Public Law 109–295; 6 

20 U.S.C. 771) regarding how to conduct environmental 

21 remediation of contaminated areas, including— 

22 (A) clarification of Federal roles and re23 sponsibilities for assisting State, local, and tribal 

24 authorities; and 


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1 (B) such other guidance as determined by 

2 the Secretary; and 

3 (3) develop exercises in consultation with State, 

4 local, and tribal authorities and other appropriate 

5 Federal agencies, to enhance collective response to and 

6 recovery from chemical, biological, radiological and 

7 nuclear attacks and incidents, including exercises that 

8 address analysis, environmental cleanup methods, 

9 and decontamination standards. 

10 (c) REPORT.—Not later than one year after the date 

11 of the enactment of this Act, the Administrator of the Envi12 ronmental Protection Agency shall submit to the appro13 priate congressional committees a report on the Adminis14 trator’s assessment under section 2162 of the Homeland Se15 curity Act of 2002, as added by section 201. 

16 SEC. 211. UNIVERSITY-BASED CENTERS FOR HOMELAND SE17 CURITY CRITERIA FOR DESIGNATION. 

18 Section 308(b)(2)(B)(iii) of the Homeland Security 

19 Act of 2002 (6 U.S.C. 188(b)(2)(B)(iii)) is amended by in20 serting before the period at the end the following ‘‘, includ21 ing medical readiness training and research, and commu22 nity resiliency for public health and healthcare critical in23 frastructure’’. 


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1 TITLE III—PUBLIC HEALTH 

2 MATTERS 

3 SEC. 301. NATIONAL MEDICAL COUNTERMEASURE DIS4 PENSING STRATEGY. 

5 Title III of the Public Health Service Act is amended 

6 by inserting after section 319F–4 (42 U.S.C. 247d–6e) the 

7 following: 

8 ‘‘SEC. 319F–5. NATIONAL MEDICAL COUNTERMEASURE DIS9 PENSING STRATEGY. 

10 ‘‘(a) DEFINITIONS.—In this section— 

11 ‘‘(1) the term ‘dispense’ means to provide med12 ical countermeasures to an affected population in re13 sponse to a threat or incident; and 

14 ‘‘(2) the term ‘medical countermeasure’ means a 

15 qualified countermeasure (as defined in section 319F– 

16 1(a)(2)). 

17 ‘‘(b) STRATEGY.—The Secretary, in coordination with 

18 the Secretary of Homeland Security, the Secretary of Agri19 culture, and other appropriate Federal agencies, shall de20 velop, implement, and, as appropriate, periodically update 

21 a National Medical Countermeasure Dispensing Strategy to 

22 enhance preparedness and collective response to a terrorist 

23 attack on humans or animals with any chemical, biological, 

24 radiological, or nuclear material. 


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1 ‘‘(c) COORDINATION.—Where appropriate, the Sec2 retary shall coordinate with State, local, and tribal authori3 ties, private sector, and nongovernmental organizations on 

4 the National Medical Countermeasures Dispensing Strat5 egy. 

6 ‘‘(d) REPORT.—Not later than one year after the date 

7 of the enactment of this section, the Secretary, in coordina8 tion with the Secretary of Homeland Security, shall submit 

9 the National Medical Countermeasures Dispensing Strategy 

10 to the appropriate congressional committees.’’. 

11 SEC. 302. MATERIAL THREAT ASSESSMENTS AND DETER12 MINATIONS. 

13 Section 319F–2(c)(2)(A) of the Public Health Service 

14 Act (42 U.S.C. Sec 247d-6b(c)(2)(A)) is amended— 

15 (1) in clause (i), by striking ‘‘and’’ at the end; 

16 (2) in clause (ii), by striking the period at the 

17 end and inserting ‘‘; and’’; and 

18 (3) by adding at the end the following: 

19 ‘‘(iii) review and reassess determina20 tions under clause (ii) to determine whether 

21 agents continue to present a material threat 

22 against the United States population suffi23 cient to affect national security and home24 land security.’’. 


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1 SEC. 303. NATIONAL PRE-EVENT VACCINATION AND ANTI2 MICROBIAL DISPENSING POLICY REVIEW. 

3 (a) REQUIREMENT.—The Secretary of Health and 

4 Human Services, in coordination with the Secretary of 

5 Homeland Security, shall review the adequacy of domestic 

6 vaccination and antimicrobial dispensing policy, guidance, 

7 and information provided to the public in light of any 

8 known terrorist risk of a biological attack or other phe9 nomena that may have serious health consequences for the 

10 United States, including wide-scale fatalities or infectious 

11 disease outbreaks. In carrying out the review under this sec12 tion, the Secretary shall consider— 

13 (1) material threat assessments and determina14 tions conducted by the Department of Homeland Se15 curity; 

16 (2) reports on global trends and intelligence pro17 duced by the Office of the Director of National Intel18 ligence and the Intelligence Community regarding bi19 ological threats; 

20 (3) the availability of domestic vaccine and 

21 antimicrobials to dispense to the public, on a vol22 untary basis, in anticipation of a biological attack; 

23 and 

24 (4) making surplus or expiring domestic vaccine 

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1 al emergency responders, including health care re2 sponders, on a voluntary basis. 

3 (b) REPORT.—Not later than one year after the date 

4 of the enactment of this Act, the Secretary of Health and 

5 Human Services shall submit to the appropriate congres6 sional committees a report on the review required by sub7 section (a), together with any recommendations relating to 

8 the availability of domestic vaccine and antimicrobials for 

9 disbursing to the public and voluntary immunization by 

10 first responders. 

11 SEC. 304. DESIGNATION OF TIER 1 MATERIAL THREAT 

12 AGENTS. 

13 (a) PUBLIC HEALTH SERVICE ACT.—Section 351A of 

14 the Public Health Service Act (42 U.S.C. 262a) is amended 

15 in subsection (a)— 

16 (1) by redesignating paragraph (2) as para17 graph (3); 

18 (2) by inserting after paragraph (1) the fol19 lowing: 

20 ‘‘(2) TIER I MATERIAL THREAT AGENTS.— 

21 ‘‘(A) DESIGNATION OF TIER I: MATERIAL

22 THREAT AGENTS.—Not later than 1 year after 

23 the date of the enactment of this paragraph, the 

24 Secretary, in coordination with the Secretary of 

25 Homeland Security and other Federal officials 


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1 as appropriate, shall by regulation designate as 

2 ‘Tier I Material Threat Agents’ those agents and 

3 toxins— 

4 ‘‘(i) that— 

5 ‘‘(I) are determined by the Sec6 retary of Homeland Security under 

7 section 319F-2(c)(2) to present a mate8 rial threat against the United States 

9 population sufficient to affect national 

10 security; and 

11 ‘‘(II) are determined to warrant 

12 designation after applying the criteria 

13 in subparagraph (B); or 

14 ‘‘(ii) that clearly present a material 

15 threat to the Nation as otherwise deter16 mined by the Secretary or the Secretary of 

17 Homeland Security. 

18 ‘‘(B) CRITERIA.—In determining whether to 

19 designate an agent or toxin as a Tier I Material 

20 Threat Agent under subparagraph (A)(i), the 

21 Secretary, in coordination with the Secretary of 

22 Homeland Security, shall consider— 

23 ‘‘(i) whether the agent or toxin can be 

24 used effectively in a biological attack; 


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1 ‘‘(ii) information available from any 

2 biological or bioterrorism risk assessments 

3 conducted by the Department of Homeland 

4 Security and relevant assessments by other 

5 agencies; and 

6 ‘‘(iii) such other criteria and informa7 tion as the Secretary, in coordination with 

8 the Secretary of Homeland Security, deter9 mines appropriate and relevant. 

10 ‘‘(C) INCLUSION OF AGENTS AND TOXINS

11 NOT PREVIOUSLY LISTED.—All agents or toxins 

12 designated by the Secretary as Tier I Material 

13 Threat Agents shall be included on the list main14 tained by the Secretary pursuant to paragraph 

15 (1). 

16 ‘‘(D) EVALUATION OF TIER I MATERIAL

17 THREAT AGENTS.—The Secretary, in coordina18 tion with the Secretary of Homeland Security, 

19 shall— 

20 ‘‘(i) on an ongoing basis, consider the 

21 inclusion of additional agents or toxins on 

22 the list of Tier I Material Threat Agents, as 

23 appropriate; and 

24 ‘‘(ii) at least biennially, review the list 

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1 mine whether any agents or toxins should 

2 be removed from the list.’’; and 

3 (3) in paragraph (3), as so redesignated— 

4 (A) by striking ‘‘list under paragraph (1)’’ 

5 and inserting ‘‘lists under paragraphs (1) and 

6 (2)’’; and 

7 (B) by striking ‘‘revise the list’’ and insert8 ing ‘‘revise the lists’’. 

9 (b) AGRICULTURAL BIOTERRORISM PROTECTION ACT

10 OF 2002.—Section 212(a) of the Agricultural Bioterrorism 

11 Protection Act of 2002 (7 U.S.C. 8401(a)) is amended— 

12 (1) by redesignating paragraph (2) as para13 graph (3); 

14 (2) by inserting after paragraph (1) the fol15 lowing: 

16 ‘‘(2) TIER I MATERIAL THREAT AGENTS.— 

17 ‘‘(A) DESIGNATION OF TIER I: MATERIAL

18 THREAT AGENTS.—Not later than one year after 

19 the date of the enactment of this paragraph, the 

20 Secretary, in coordination with the Secretary of 

21 Homeland Security, the Secretary of Health and 

22 Human Services, and other Federal officials as 

23 appropriate, shall by regulation designate as 

24 ‘Tier I Material Threat Agents’ those agents and 

25 toxins— 


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1 ‘‘(i) that— 

2 ‘‘(I) are determined by the Sec3 retary of Homeland Security under 

4 section 319F-2(c)(2) of the Public 

5 Health Service Act to present a mate6 rial threat against the United States 

7 population sufficient to affect national 

8 security; and 

9 ‘‘(II) are determined to warrant 

10 designation after applying the criteria 

11 in subparagraph (B); or 

12 ‘‘(ii) that clearly present a material 

13 threat to the Nation as otherwise deter14 mined by the Secretary or the Secretary of 

15 Homeland Security. 

16 ‘‘(B) CRITERIA.—In determining whether to 

17 designate an agent or toxin as a Tier I Material 

18 Threat Agent under subparagraph (A)(i), the 

19 Secretary, in coordination with the Secretary of 

20 Homeland Security, shall consider— 

21 ‘‘(i) whether the agent or toxin can be 

22 used effectively in a biological attack; 

23 ‘‘(ii) information available from any 

24 biological or bioterrorism risk assessments 

25 conducted by the Department of Homeland 


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1 Security and relevant assessments by other 

2 agencies; and 

3 ‘‘(iii) such other criteria and informa4 tion that the Secretary, in coordination 

5 with the Secretary of Homeland Security, 

6 determines appropriate and relevant. 

7 ‘‘(C) INCLUSION OF AGENTS AND TOXINS

8 NOT PREVIOUSLY LISTED.—All agents or toxins 

9 designated by the Secretary as Tier 1 Material 

10 Threat Agents shall be included on the list main11 tained by the Secretary pursuant to paragraph 

12 (1). 

13 ‘‘(D) EVALUATION OF TIER I MATERIAL

14 THREAT AGENTS.—The Secretary, in coordina15 tion with the Secretary of Homeland Security, 

16 shall— 

17 ‘‘(i) on an ongoing basis, consider the 

18 inclusion of additional agents or toxins on 

19 the list of Tier I Material Threat Agents, as 

20 appropriate; and 

21 ‘‘(ii) at least biennially, review the list 

22 of Tier I Material Threat agents to deter23 mine whether any agents or toxins should 

24 be removed from the list.’’; and 

25 (3) in paragraph (3), as so redesignated— 


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1 (A) by striking ‘‘list under paragraph (1)’’ 

2 and inserting ‘‘lists under paragraphs (1) and 

3 (2)’’; and 

4 (B) by striking ‘‘revise the list’’ and insert5 ing ‘‘revise the lists’’. 

6 SEC. 305. BACKGROUND CHECKS. 

7 Section 351A(e)(3)(A) of the Public Health Service Act 

8 (42 U.S.C. 262a(e)(3)(A)) is amended by adding at the end 

9 the following: ‘‘In identifying whether an individual is 

10 within a category specified in subparagraph (B)(ii)(II), the 

11 Attorney General shall coordinate with the Secretary of 

12 Homeland Security, the Secretary of Defense, and the Sec13 retary of State to determine whether these officials possess 

14 any information relevant to the identification of such an 

15 individual by the Attorney General.’’. 

16 SEC. 306. BIOTECHNOLOGY RESEARCH, DEVELOPMENT, 

17 AND PROCUREMENT. 

18 Title III of the Public Health Service Act is amended 

19 by inserting after section 319M (42 U.S.C. 247d–f) the fol20 lowing: 

21 ‘‘SEC. 319N. BIOTECHNOLOGY RESEARCH, DEVELOPMENT, 

22 AND PROCUREMENT. 

23 ‘‘(a) IN GENERAL.—The Secretary shall develop a 

24 comprehensive research, development, and acquisition proc25 ess to counter the biological threat that employs the inherent 


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1 functions, capabilities, authorities, and responsibilities of 

2 NIH, BARDA, and Project BioShield. The process shall— 

3 ‘‘(1) assign NIH responsibility for research and 

4 development of technologies that range in development 

5 from basic principles observed and reported up to 

6 model or prototype demonstration in a relevant envi7 ronment; 

8 ‘‘(2) assign BARDA responsibility for research 

9 and development of technologies that range in devel10 opment from model or prototype demonstration in a 

11 relevant environment up to a system qualified for ap12 plication through successful test and demonstration; 

13 ‘‘(3) assign Project BioShield responsibility for 

14 procurement of technologies that— 

15 ‘‘(A) are qualified for application through 

16 successful test and demonstration; and 

17 ‘‘(B) meet the minimum statutory require18 ments for emergency use authorization in section 

19 564 of the Federal Food, Drug, and Cosmetic 

20 Act; and 

21 ‘‘(4) include a formal agreement among NIH, 

22 BARDA, and Project BioShield that— 

23 ‘‘(A) identifies the need for any specific bio24 logical countermeasure, derived from information 

25 developed under section 319F–2; 


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1 ‘‘(B) identifies the current technology readi2 ness level of the countermeasure; and 

3 ‘‘(C) requires the development of the biologi4 cal countermeasure from the current technology 

5 readiness level through the procurement of the 

6 countermeasure in accordance with paragraph 

7 (3). 

8 ‘‘(b) RESPONSIBILITY OF NIH.—For countermeasures 

9 identified under subsection (a)(4)(A) that have a level of 

10 development from basic principles observed and reported up 

11 to model or prototype demonstration in a relevant environ12 ment, the Director of NIH shall conduct research and devel13 opment until the Director certifies to the Secretary of 

14 Health and Human Services that— 

15 ‘‘(1) the countermeasure has completed model or 

16 prototype demonstration in a relevant environment; 

17 or 

18 ‘‘(2) the Director does not believe that completion 

19 of model or prototype demonstration in a relevant en20 vironment is reasonably achievable. 

21 ‘‘(c) RESPONSIBILITY OF BARDA.—For counter22 measures identified under subsection (a)(4)(A) that have a 

23 level of development of model or prototype demonstration 

24 in a relevant environment, including but not limited to 

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1 ment by the Director of NIH, the Director of BARDA shall 

2 conduct research and development until the Director of 

3 BARDA certifies to the Secretary of Health and Human 

4 Services that— 

5 ‘‘(1) the countermeasure has qualified for appli6 cation through successful test and demonstration; or 

7 ‘‘(2) the Director does not believe that qualifica8 tion for application through successful test and dem9 onstration is reasonably achievable. 

10 ‘‘(d) RESPONSIBILITY OF PROJECT BIOSHIELD.—For 

11 countermeasures identified under subsection (a)(4)(A) that 

12 are qualified for application through successful test and 

13 demonstration, including but not limited to those counter14 measures certified to have qualified for application through 

15 successful test and demonstration by the Director of 

16 BARDA, the Assistant Secretary of Health and Human 

17 Services for Preparedness and Response shall use the Project 

18 BioShield special reserve fund to may procure the counter19 measure if the countermeasure meets the requirements for 

20 emergency use authorization described in subsection 

21 (a)(3)(B). 

22 ‘‘(e) NO REQUIREMENT FOR FOOD AND DRUG ADMIN23 ISTRATION GENERAL USE APPROVAL.—The Secretary shall 

24 ensure that the Directors of NIH and BARDA and the As25 sistant Secretary of Health and Human Services for PreVerDate Mar 15 2010 01:18 Dec 23, 2010 Jkt 099200 PO 00000 Frm 00090 Fmt 6652 Sfmt 6203 E:\BILLS\H5498.RH H5498

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1 paredness and Response do not discontinue any research, 

2 development, or procurement of a countermeasure identified 

3 under subsection (a)(4)(A) because the Food and Drug Ad4 ministration has not, or decides against, approving or li5 censing the countermeasure for general use under chapter 

6 V of the Federal Food, Drug, and Cosmetic Act or section 

7 351 of this Act, as applicable. 

8 ‘‘(f) INNOVATION.—The Secretary shall require the Di9 rectors of NIH and BARDA and the Assistant Secretary 

10 of Health and Human Services for Preparedness and Re11 sponse to aggressively pursue innovative research, develop12 ment, and procurement of each countermeasure identified 

13 under subsection (a)(4)(A). 

14 ‘‘(g) DEFINITIONS.—In this section: 

15 ‘‘(1) The term ‘BARDA’ means the he Bio16 medical Advanced Research and Development Author17 ity established under section 319L(c). 

18 ‘‘(2) The term ‘NIH’ means the National Insti19 tutes of Health. 

20 ‘‘(3) The term ‘Project Bioshield’ means the Fed21 eral medical countermeasure procurement program es22 tablished by Public Law 108–276.’’. 


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1 TITLE IV—FOREIGN RELATIONS 

2 MATTERS 

3 SEC. 401. INTERNATIONAL COLLABORATION AND INFORMA4 TION SHARING RELATING TO BIOSECURITY. 

5 The Secretary of State, in coordination with the Sec6 retary of Homeland Security, the Secretary of Agriculture, 

7 the Secretary of Health and Human Services, and the heads 

8 of other appropriate Federal agencies, shall— 

9 (1) support efforts in other countries and regions 

10 to develop mechanisms and capabilities for reporting 

11 to United Nations organizations validated data on bi12 ological attacks or other phenomena that may have se13 rious health consequences for the United States, in14 cluding wide-scale fatalities or infectious disease out15 breaks; 

16 (2) engage other Federal and nongovernmental 

17 entities and other countries to advance awareness and 

18 understanding of the risk posed by information de19 rived from the life sciences that has the potential for 

20 misuse to cause harm, and advance recommendations 

21 on how best to address such risk; 

22 (3) engage such entities and countries to promote 

23 greater awareness and understanding of the global 

24 availability of and access to life science technologies 

25 and materials; and 


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1 (4) promote the development and use of mecha2 nisms for reporting, preserving, and sharing data on 

3 Federal programs and investments in international 

4 scientific, agricultural, medical, and public health 

5 collaborations in support of efforts to enhance global 

6 biosecurity. 

7 SEC. 402. INTERNATIONAL ENGAGEMENT TO ENHANCE BIO8 DEFENSE AND BIOSECURITY. 

9 The Secretary of State, in coordination and consulta10 tion with the Secretary of Homeland Security, and the 

11 heads other appropriate Federal agencies, shall, as appro12 priate— 

13 (1) support efforts of other countries to establish 

14 and build capacity to effectively implement legislation 

15 criminalizing the development or use of biological 

16 weapons or acts of bioterrorism; 

17 (2) engage other countries and international 

18 nongovernmental entities to develop and establish 

19 common standards, guidance, and best practices for 

20 actions relevant to preventing acts of bioterrorism 

21 and the illicit use of life sciences; 

22 (3) support the efforts of other countries to en23 hance biosecurity and safety practices at laboratories 

24 and other facilities with materials that could be used 

25 in biological weapons or in an act of bioterrorism; 


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1 (4) promote the development and adoption of 

2 international guidance for the safety and security of 

3 high-risk pathogens and toxins; and 

4 (5) promote information sharing relating to 

5 threats and best practices between the intelligence 

6 community, Federal law enforcement, and inter7 national law enforcement and security officials. 

8 SEC. 403. INTERAGENCY TASK FORCE ON BEST PRACTICES 

9 FOR GLOBAL BIOPREPAREDNESS. 

10 (a) SENSE OF CONGRESS.—It is the sense of Congress 

11 that preparedness for a chemical, biological, radiological, 

12 or nuclear incident must be undertaken not only domesti13 cally but also internationally. Specifically, there is a need 

14 for a global preparedness architecture for such an event. 

15 Congress supports efforts to provide an international forum 

16 for discussion of key health security policies with inter17 national dimensions, and the establishment of a formal 

18 United States interagency task force to develop best prac19 tices and recommendations for implementation of a global 

20 preparedness architecture could enhance global prepared21 ness. 

22 (b) ESTABLISHMENT OF TASK FORCE.—The Secretary 

23 of State shall convene and lead an interagency task force 

24 to examine— 


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1 (1) the state of global biopreparedness for a 

2 major biological event; 

3 (2) necessary components of a global bio4 preparedness architecture that would advance inter5 national health security, including considerations 

6 of— 

7 (A) risk assessments; 

8 (B) prevention and deterrence; 

9 (C) detection; 

10 (D) regional stockpiling of medical counter11 measures, including considerations of— 

12 (i) security of the stockpile; 

13 (ii) delivery planning; and 

14 (iii) legal dimensions of and obstacles 

15 to implementing such an architecture; 

16 (E) attribution; 

17 (F) response; 

18 (G) other elements that should be a compo19 nent of such an architecture; and 

20 (H) obstacles to implementing such an ar21 chitecture; 

22 (3) best practices for preparedness based on les23 sons learned from domestic efforts to address the above 

24 issues, and that may be applicable internationally; 


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1 (4) activities undertaken through the National 

2 Strategy for Countering Biological Threats and the 

3 International Health Regulations 2005, as well as 

4 other activities deemed relevant by the task force; and 

5 (5) the utility of working through existing inter6 national forums as a mechanism for distributing this 

7 information to the international community. 

8 (c) MEMBERSHIP.—Members of the task force shall in9 clude representatives from— 

10 (1) the Department of Homeland Security; 

11 (2) the Department of Health and Human Serv12 ices, including the Centers for Disease Control and 

13 Prevention; 

14 (3) the Department of Agriculture; 

15 (4) the Department of Defense; 

16 (5) the Department of Justice; 

17 (6) the Department of State; 

18 (7) the United States Agency for International 

19 Development; 

20 (8) the Director of National Intelligence; 

21 (9) other Federal Departments and agencies, as 

22 determined appropriate by the Secretary; and 

23 (10) other national biosecurity and biodefense 

24 stakeholders, including private sector, including the 

25 pharmaceutical industry and the biological laboratory 


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1 community, as determined appropriate by the Sec2 retary. 

3 (d) REPORT.—Not later than 18 months after the date 

4 of the enactment of this Act, the Secretary shall submit to 

5 the appropriate congressional committees a report on the 

6 findings of the task force established under this section. 

7 SEC. 404. BIOLOGICAL AND TOXIN WEAPONS CONVENTION. 

8 The Secretary of State shall— 

9 (1) promote confidence in effective implementa10 tion of and compliance with the Convention on the 

11 Prohibition of the Development, Production and 

12 Stockpiling of Bacteriological (Biological) and Toxin 

13 Weapons and on their Destruction (commonly re14 ferred to as the ‘‘Biological and Toxin Weapons Con15 vention’’) by the States party to the Convention by 

16 promoting transparency with respect to legitimate ac17 tivities and pursuing compliance diplomatically to 

18 address concerns; 

19 (2) promote universal membership in the Con20 vention; 

21 (3) develop an action plan for increasing inter22 national adherence to the Convention; and 

23 (4) ensure that United States participation in 

24 Convention meetings is broadly inclusive of represent25 atives of relevant Federal departments and agencies. 


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Union Calendar No. 411 

111TH CONGRESS 

2D SESSION H. R. 5498 

[Report No. 111–659, Part I] 

A BILL 

To enhance homeland security by improving efforts 

poses. weapon of mass destruction, and for other purrespond to, and recover from an attack with a to prevent, deter, prepare for, detect, attribute, 

DECEMBER 22, 2010 

The Committee on Energy and Commerce discharged; 

the State of the Union and ordered to be printed committed to the Committee of the Whole House on 


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