‘‘(2) specific information regarding the effects of 
the chemical, biological, radiological, or nuclear mate-
rial on those exposed to the agent; and 
‘‘(3) best practices for emergency response pro-
viders to effectively deal with individuals affected by 
an incident involving chemical, biological, radio-
logical, or nuclear material. 
‘‘(c) REVIEW AND REVISION OF GUIDANCE.—The Sec-
retary shall— 
‘‘(1) review the guidance developed under sub-
section (a)(1) at least once every 2 years, 
‘‘(2) make revisions to the guidance as appro-
priate; and 
‘‘(3) make any revised guidance available to 
State, local, and tribal authorities, nongovernmental 
organizations, the private sector, and the public. 
‘‘(d) PROCEDURES FOR DEVELOPING AND REVISING 
GUIDANCE.—In carrying out the requirements of this sec-
tion, the Secretary shall establish procedures to— 
‘‘(1) inventory existing relevant hazardous mate-
rial response guidance; 
‘‘(2) enable members of the first responder and 
first provider community to submit recommendations 
of areas in which guidance is needed and could be de-
veloped under subsection (a)(1); 
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‘‘(3) determine which entities should be consulted 
in developing or revising the guidance; 
‘‘(4) prioritize, on a regular basis, guidance that 
should be developed or revised; and 
‘‘(5) develop and disseminate the guidance in ac-
cordance with the prioritization under paragraph (4). 
‘‘(e) CONSULTATIONS.—The Secretary shall develop 
and revise the guidance developed under subsection (a)(1), 
and the procedures required under subsection (d), in con-
sultation with— 
‘‘(1) the heads of other Federal departments and 
agencies, as appropriate; 
‘‘(2) the National Advisory Council established 
under section 508; 
‘‘(3) the National Domestic Preparedness Consor-
tium; 
‘‘(4) State, local, and tribal authorities; and 
‘‘(5) nongovernmental organizations and private 
industry. 
‘‘(f) REPORTING REQUIREMENTS.—Not later than 18 
months after the date of the enactment of this section and 
annually thereafter, the Secretary shall submit to the ap-
propriate congressional committees— 
‘‘(1) a description of the procedures established 
under subsection (d); 
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‘‘(2) any guidance in effect on the date of the re-
port; 
‘‘(3) a list of entities to which the guidance de-
scribed in paragraph (2) was disseminated; 
‘‘(4) a plan for reviewing the guidance described 
in paragraph (2), in accordance with subsection (e); 
‘‘(5) guidance required under subsection (d)(4), 
and the methodology used by the Secretary for such 
prioritization; and 
‘‘(6) a plan for developing, revising, and dis-
seminating the guidance. 
‘‘SEC. 2152. INTEGRATED PLUME MODELING FOR COLLEC-
TIVE RESPONSE. 
‘‘(a) DEVELOPMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall acquire, 
use, and disseminate integrated plume models to en-
able rapid response activities following a chemical, 
biological, nuclear, or radiological attack or event. 
‘‘(2) SCOPE.—The Secretary shall— 
‘‘(A) ensure the rapid development and dis-
tribution of integrated plume models to appro-
priate officials of the Federal Government and 
State, local, and tribal authorities to enable im-
mediate response to a chemical, biological, or ra-
diological attack or event; 
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‘‘(B) establish mechanisms for dissemina-
tion by appropriate emergency response officials 
of the integrated plume models described in 
paragraph (1) to nongovernmental organizations 
and the public to enable appropriate collective 
response activities; 
‘‘(C) ensure that the development and dis-
semination of integrated plume models are as-
sessed during exercises administered by the De-
partment; and 
‘‘(D) ensure that lessons learned from as-
sessing the development and dissemination of in-
tegrated plume models during exercises adminis-
tered by the Department are put into the De-
partment of Homeland Security Lessons Learned 
Information Sharing system. 
‘‘(b) REPORT.—Not later than one year after the date 
of enactment of this section, and annually thereafter, the 
Secretary shall submit to the appropriate congressional 
committees a report regarding— 
‘‘(1) the acquisition, use, and dissemination of 
integrated plume models under this section; 
‘‘(2) lessons learned from assessing the develop-
ment and dissemination of integrated plume models 
during exercises administered by the Department; and 
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‘‘(3) recommendations for improving integrated 
plume models, as appropriate. 
‘‘(c) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘plume model’ means the assess-
ment of the location and prediction of the spread of 
agents following a chemical, biological, radiological, 
or nuclear attack or event. 
‘‘(2) The term ‘integrated plume model’ means a 
plume model that integrates protective action guid-
ance and other information as the Secretary deter-
mines appropriate. 
‘‘Subtitle F—Recovery 
‘‘SEC. 2161. RECOVERY AND RESTORATION FROM A BIO-
LOGICAL ATTACK OR INCIDENT GUIDANCE. 
‘‘(a) ESTABLISHMENT OF GUIDANCE.—Not later than 
one year after the date of the enactment of this section, the 
Secretary, in coordination with the Administrator of the 
Environmental Protection Agency and in consultation with 
the Director of the Occupational Safety and Health Agency, 
and the Director of the National Institute for Occupational 
Safety and Health, shall develop and issue guidance for 
clean-up and restoration of indoor and outdoor areas, in-
cluding subways and other mass transportation facilities, 
that have been affected by a biological attack or event. 
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‘‘(b) CONTENTS.—The guidance developed under sub-
section (a) shall include— 
‘‘(1) acceptable levels of growth of the organism 
in post-remediation area samples from affected sites; 
‘‘(2) standards for effective clean-up of affected 
sites; 
‘‘(3) standards for safe post-event occupancy of 
affected sites; 
‘‘(4) requirements to ensure that the decon-
tamination procedures for responding organizations 
do not conflict; 
‘‘(5) requirements that each responding organi-
zation uses a uniform system for tracking costs and 
performance of clean-up contractors; 
‘‘(6) levels of personal protection equipment; 
‘‘(7) maintenance of negative air pressure in 
buildings; 
‘‘(8) standards for proper selection and use of 
personal protective equipment; 
‘‘(9) air sampling procedures; and 
‘‘(10) how to develop occupational health and 
safety plans that are appropriate for the specific risk 
to responder health. 
‘‘(c) REVIEW AND REVISION OF GUIDANCE.—The Sec-
retary shall— 
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‘‘(1) the heads of other Federal departments and 
agencies, as appropriate; 
‘‘(2) State, local, and tribal authorities; and 
‘‘(3) nongovernmental organizations and private 
industry. 
‘‘(f) REPORT.—Not later than one year after the date 
of the enactment of this section, and annually thereafter, 
the Secretary shall provide appropriate congressional com-
mittees with— 
‘‘(1) a description of the procedures established 
under subsection (d); 
‘‘(2) any guidance in effect on the date of the re-
port; 
‘‘(3) a list of entities to which the guidance de-
scribed in paragraph (2) were disseminated; 
‘‘(4) a plan for reviewing the guidance described 
in paragraph (2), in accordance with subsection (e); 
‘‘(5) the prioritized list of the guidance required 
under subsection (d)(4), and the methodology used by 
the Secretary for such prioritization; and 
‘‘(6) a plan for developing, revising, and dis-
seminating the guidance.’’. 
(b) CLERICAL AMENDMENTS.—The table of contents in 
section 1(b) of such Act is amended by adding at the end 
the following new items: 
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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 bio-
defense. 
‘‘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 emer-
gency responders (SAVER) program. 
‘‘Sec. 2135. Payment for bioterrorism laboratory services. 
‘‘Sec. 2136. Establishment of the integrated consortium of laboratory net-
works. 
‘‘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 destruc-
tion 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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SEC. 202. DEFINITIONS. 
Section 2 of the Homeland Security Act of 2002 (6 
U.S.C. 101) is amended by adding at the end the following 
new paragraphs: 
‘‘(19) The term ‘weapon of mass destruction’ has 
the meaning given that term in section 1403(1) fo the 
Defense Against Weapons of Mass Destruction Act of 
1996 (50 U.S.C. 2302). 
‘‘(20) The term ‘Intelligence Community’ has the 
meaning given that term in section 3(4) of the Na-
tional Security Act of 1947 (50 U.S.C. 401a(4)). 
‘‘(21) The term ‘national biosecurity and bio-
defense stakeholders’ means officials from the Federal, 
State, local, and tribal authorities and individuals 
from the private sector who are involved in efforts to 
prevent, deter, prepare for, detect, attribute, respond, 
and recover from a biological attack or other phe-
nomena that may have serious health consequences for 
the United States, including wide-scale fatalities or 
infectious disease outbreaks. 
‘‘(22) The term ‘Tier I Material Threat Agent’ 
means a substance so designated under section 
351A(a)(2) of the Public Health Service Act or section 
212(a)(2) of the Agricultural Bioterrorism Protection 
Act of 2002.’’. 
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SEC. 203. DUAL-USE TERRORIST RISKS FROM SYNTHETIC 
GENOMICS. 
(a) SENSE OF CONGRESS.—It is the sense of Congress 
that the field of synthetic genomics has the potential to fa-
cilitate enormous gains in fundamental discovery and bio-
technological applications, but it also has inherent dual- 
use homeland security risks that must be managed. 
(b) REQUIREMENT.—Not later than one year after the 
date of enactment of this Act, the Secretary of Homeland 
Security, acting through the Under Secretary of Homeland 
Security for Science and Technology, shall examine and re-
port to the appropriate congressional committees on the 
homeland security implications of the dual-use nature of 
synthetic genomics, and if the Under Secretary determines 
that such research is appropriate, may conduct research in 
that area, including— 
(1) determining the current capability of syn-
thetic nucleic acid providers to effectively differentiate 
a legitimate customer from a potential terrorist or 
other malicious actor; 
(2) determining the current capability of syn-
thetic nucleic acid providers to effectively screen or-
ders for sequences of homeland security concern; and 
(3) making recommendations regarding screen-
ing software, protocols, and other remaining capa-
bility gaps uncovered by the study. 
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SEC. 204. DISSEMINATION OF INFORMATION ANALYZED BY 
THE DEPARTMENT TO STATE, LOCAL, TRIBAL, 
AND PRIVATE ENTITIES WITH RESPONSIBIL-
ITIES RELATING TO HOMELAND SECURITY. 
(a) RESPONSIBILITIES OF THE SECRETARY.—Section 
201(d)(8) of the Homeland Security Act of 2002 (6 U.S.C. 
121(d)(8)) is amended by striking ‘‘and to agencies of 
State’’ and all that follows and inserting ‘‘to State, local, 
tribal, and private entities with such responsibilities, and, 
as appropriate, to the public, in order to assist in pre-
venting, deterring, or responding to acts of terrorism 
against the United States.’’. 
(b) REPORT.—Not later than one year after the date 
of the enactment of this Act, the Secretary of Homeland Se-
curity shall submit to the appropriate congressional com-
mittees a report on the implementation of this section. 
SEC. 205. NATIONAL BIOSURVEILLANCE INTEGRATION CEN-
TER (NBIC). 
Section 316 of the Homeland Security Act of 2002 (6 
U.S.C. 195b) is amended— 
(1) in subsection (a), by striking ‘‘an office or 
directorate of the Department’’ and all that follows 
through the period at the end and inserting the fol-
lowing: ‘‘the Office of Intelligence and Analysis.’’; 
(2) in subsection (d)(2)(B)— 
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‘‘(j) ANNUAL REPORT.—Not later than one year after 
the date of the enactment of the WMD Prevention and Pre-
paredness Act of 2010 and annually thereafter, the Sec-
retary shall submit to the appropriate congressional com-
mittees a report on— 
‘‘(1) the status of operations at the National Bio-
surveillance Integration Center of the Department 
under section 316; 
‘‘(2) efforts by the Office of Intelligence and 
Analysis to take responsibility for the National Bio-
surveillance Integration Center; and 
‘‘(3) efforts to integrate the biosurveillance efforts 
of Federal, State, local, and tribal authorities.’’. 
SEC. 206. REPORT ON ESTABLISHMENT OF THE SYSTEM AS-
SESSMENT 
AND 
VALIDATION 
FOR 
EMER-
GENCY RESPONDERS (SAVER) PROGRAM. 
Not later than one year after the date of the enactment 
of this Act, the Secretary of Homeland Security shall sub-
mit to the appropriate congressional committees a report 
on the SAVER Program under section 2134 of the Home-
land Security Act of 2002, as added by section 201. 
SEC. 207. NATIONAL ACADEMY OF SCIENCES STUDY OF FO-
RENSIC SCIENCE IN HOMELAND SECURITY. 
(a) STUDY.—Not later than 90 days after the date of 
the enactment of this Act, the Secretary of Homeland Secu-
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rity, acting through the Under Secretary of Homeland Se-
curity for Science and Technology, shall seek to enter into 
an agreement with the National Academy of Sciences to— 
(1) conduct a study, building on previous studies 
conducted by the National Academy of Sciences, on 
the role of forensic science in homeland security; and 
(2) issue recommendations to enhance this home-
land security capability to investigate attacks from 
weapons of mass destruction, terrorist incidents, and 
other crimes investigated by the Department. 
(b) REPORT.—Not later than two years after the date 
of the enactment of this Act, the Secretary shall submit to 
the appropriate congressional committees a report con-
taining the results of the National Academy of Sciences 
study required under subsection (a), together with any rec-
ommendations of the Secretary related thereto. 
(c) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated to the Department, for fiscal 
year 2011, $1,000,000 to carry out this section. 
SEC. 208. HARMONIZATION OF REGULATIONS. 
(a) REGULATIONS UNDER PUBLIC HEALTH SERVICE 
ACT.—Not later than one year after the Secretary of Home-
land Security promulgates regulations or amendments 
thereto to carry out section 2104 of the Homeland Security 
Act of 2002, as added by section 201, the Secretary of 
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Health and Human Services shall amend regulations pro-
mulgated under the Select Agent Program under section 
351A(b)(1) of the Public Health Service Act (42 U.S.C. 
262a(b)(1)) to ensure that such regulations are not redun-
dant or are not in conflict with the regulations promulgated 
by the Secretary under such section 2104. 
(b) REGULATIONS UNDER AGRICULTURE BIOTER-
RORISM PROTECTION ACT OF 2002.—Not later than one 
year after the Secretary of Homeland Security promulgates 
regulations or amendments thereto pursuant to such section 
2104, the Secretary of Agriculture shall amend regulations 
promulgated under the Select Agent Program under section 
212(b)(1) of the Agricultural Bioterrorism Protection Act 
of 2002 (7 U.S.C. 8401(b)(1)) to ensure that such regula-
tions are not redundant or are not in conflict with the regu-
lations promulgated by the Secretary under such section 
2104. 
SEC. 209. COMMUNICATIONS PLANNING FOR WEAPONS OF 
MASS DESTRUCTION INFORMATION DISSEMI-
NATION. 
(a) COMMUNICATIONS
PLANS
REQUIRED.—Section 
653 of the Post-Katrina Emergency Management Reform 
Act of 2006 (6 U.S.C. 753) is amended— 
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(1) in subsection (a)(4), by inserting after ‘‘man- 
made disasters’’ the following ‘‘, and a communica-
tions plan described in subsection (f)’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(f) COMMUNICATIONS PLAN.— 
‘‘(1) IN GENERAL.—A communications plan de-
veloped under subsection (a)(4) shall be designed to 
provide information to the public related to pre-
venting, preparing for, and responding to attacks 
from weapons of mass destruction and acts of ter-
rorism; 
‘‘(2) CONSULTATION.—As appropriate, the Ad-
ministrator shall consult with State, local, and tribal 
authorities and coordinate with other Federal depart-
ments and agencies in developing communications 
plans under paragraph (1). 
‘‘(3) PRE-SCRIPTED
MESSAGES
AND
MESSAGE 
TEMPLATES.— 
‘‘(A) IN
GENERAL.—The Administrator 
shall develop and disseminate pre-scripted mes-
sages and message templates to be provided to 
State, local, and tribal authorities so that those 
authorities can quickly and rapidly disseminate 
critical information to the public in anticipation 
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of, during, or in the immediate aftermath of an 
attack from a weapon of mass destruction or ter-
rorist incident, and to be included in the Depart-
ment of Homeland Security’s Lessons Learned 
Information Sharing system. 
‘‘(B) DEVELOPMENT
AND
DESIGN.—The 
pre-scripted messages or message templates 
shall— 
‘‘(i) be developed in consultation with 
State, local, and tribal authorities and in 
coordination with other appropriate Federal 
departments and agencies; 
‘‘(ii) be designed to provide accurate, 
essential, and appropriate information and 
instructions to the population directly af-
fected by an incident, including informa-
tion regarding an evacuation, sheltering in 
place, hospital surge operations, health, and 
safety; and 
‘‘(iii) be designed to provide accurate, 
essential, and appropriate information and 
instructions to emergency response pro-
viders and medical personnel responding to 
an incident. 
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‘‘(C) COMMUNICATIONS FORMATS.—The Ad-
ministrator shall develop pre-scripted messages 
or message templates under this paragraph in 
multiple formats to ensure delivery— 
‘‘(i) in cases where the usual commu-
nications infrastructure is unusable; and 
‘‘(ii) to individuals with disabilities or 
other special needs and individuals with 
limited English proficiency. 
‘‘(D) DISSEMINATION AND TECHNICAL AS-
SISTANCE.—The Administrator shall ensure that 
all pre-scripted messages and message templates 
developed under this paragraph are made avail-
able to State, local, and tribal authorities so that 
those authorities may incorporate them, as ap-
propriate, into their emergency plans. The Ad-
ministrator shall also make available relevant 
technical assistance to those authorities to sup-
port communications planning. 
‘‘(E) EXERCISES.—To ensure that the pre- 
scripted messages or message templates developed 
under this paragraph can be effectively utilized 
in a disaster or incident, the Administrator shall 
incorporate such pre-scripted messages or mes-
sage templates into exercises conducted under the 
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National Exercise Program described in section 
648 of the Post-Katrina Emergency Management 
Reform Act of 2006 (6 U.S.C. 748).’’. 
(b) REPORT.—Not later than one year after the date 
of the enactment of this Act, the Administrator shall submit 
to the appropriate congressional committees the commu-
nications plans required to be developed under the amend-
ments made by subsection (a), including pre-scripted mes-
sages or message templates developed in conjunction with 
the plans and a description of the means that will be used 
to deliver these messages during such incidents. 
SEC. 210. ENVIRONMENTAL RECOVERY FROM CHEMICAL, BI-
OLOGICAL, RADIOLOGICAL, AND NUCLEAR 
ATTACKS. 
(a) IN GENERAL.—To facilitate environmental recov-
ery from a chemical, biological, radiological, or nuclear at-
tack or other incident involving chemical, biological, radio-
logical, or nuclear materials and to foster collective response 
to terrorism, the Administrator of the Environmental Pro-
tection Agency, in coordination with the Administrator of 
the Federal Emergency Management Agency, shall assess 
capability gaps in environmental recovery preparedness 
and provide guidance to State, local, and tribal authorities. 
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(b) REQUIREMENTS.—In carrying out subsection (a), 
the Administrator of the Environmental Protection Agency 
shall— 
(1) assess capability gaps in the Nation’s ability 
to recover from chemical, biological, radiological, and 
nuclear attacks or incidents, with specific attention 
to— 
(A) decontamination standards, gaps in 
such standards, and recommendations for re-
search to minimize these gaps; 
(B) environmental remediation methods; 
and 
(C) such other components as determined by 
the Secretary; 
(2) disseminate guidance to State, local, and 
tribal authorities that conforms to the goals of the Na-
tional Disaster Recovery Strategy as required in Sec-
tion 682 of the Department of Homeland Security 
Appropriations Act, 2007 (Public Law 109–295; 6 
U.S.C. 771) regarding how to conduct environmental 
remediation of contaminated areas, including— 
(A) clarification of Federal roles and re-
sponsibilities for assisting State, local, and tribal 
authorities; and 
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(B) such other guidance as determined by 
the Secretary; and 
(3) develop exercises in consultation with State, 
local, and tribal authorities and other appropriate 
Federal agencies, to enhance collective response to and 
recovery from chemical, biological, radiological and 
nuclear attacks and incidents, including exercises that 
address analysis, environmental cleanup methods, 
and decontamination standards. 
(c) REPORT.—Not later than one year after the date 
of the enactment of this Act, the Administrator of the Envi-
ronmental Protection Agency shall submit to the appro-
priate congressional committees a report on the Adminis-
trator’s assessment under section 2162 of the Homeland Se-
curity Act of 2002, as added by section 201. 
SEC. 211. UNIVERSITY-BASED CENTERS FOR HOMELAND SE-
CURITY CRITERIA FOR DESIGNATION. 
Section 308(b)(2)(B)(iii) of the Homeland Security 
Act of 2002 (6 U.S.C. 188(b)(2)(B)(iii)) is amended by in-
serting before the period at the end the following ‘‘, includ-
ing medical readiness training and research, and commu-
nity resiliency for public health and healthcare critical in-
frastructure’’. 
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TITLE III—PUBLIC HEALTH 
MATTERS 
SEC. 301. NATIONAL MEDICAL COUNTERMEASURE DIS-
PENSING STRATEGY. 
Title III of the Public Health Service Act is amended 
by inserting after section 319F–4 (42 U.S.C. 247d–6e) the 
following: 
‘‘SEC. 319F–5. NATIONAL MEDICAL COUNTERMEASURE DIS-
PENSING STRATEGY. 
‘‘(a) DEFINITIONS.—In this section— 
‘‘(1) the term ‘dispense’ means to provide med-
ical countermeasures to an affected population in re-
sponse to a threat or incident; and 
‘‘(2) the term ‘medical countermeasure’ means a 
qualified countermeasure (as defined in section 319F– 
1(a)(2)). 
‘‘(b) STRATEGY.—The Secretary, in coordination with 
the Secretary of Homeland Security, the Secretary of Agri-
culture, and other appropriate Federal agencies, shall de-
velop, implement, and, as appropriate, periodically update 
a National Medical Countermeasure Dispensing Strategy to 
enhance preparedness and collective response to a terrorist 
attack on humans or animals with any chemical, biological, 
radiological, or nuclear material. 
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‘‘(c) COORDINATION.—Where appropriate, the Sec-
retary shall coordinate with State, local, and tribal authori-
ties, private sector, and nongovernmental organizations on 
the National Medical Countermeasures Dispensing Strat-
egy. 
‘‘(d) REPORT.—Not later than one year after the date 
of the enactment of this section, the Secretary, in coordina-
tion with the Secretary of Homeland Security, shall submit 
the National Medical Countermeasures Dispensing Strategy 
to the appropriate congressional committees.’’. 
SEC. 302. MATERIAL THREAT ASSESSMENTS AND DETER-
MINATIONS. 
Section 319F–2(c)(2)(A) of the Public Health Service 
Act (42 U.S.C. Sec 247d-6b(c)(2)(A)) is amended— 
(1) in clause (i), by striking ‘‘and’’ at the end; 
(2) in clause (ii), by striking the period at the 
end and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(iii) review and reassess determina-
tions under clause (ii) to determine whether 
agents continue to present a material threat 
against the United States population suffi-
cient to affect national security and home-
land security.’’. 
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SEC. 303. NATIONAL PRE-EVENT VACCINATION AND ANTI-
MICROBIAL DISPENSING POLICY REVIEW. 
(a) REQUIREMENT.—The Secretary of Health and 
Human Services, in coordination with the Secretary of 
Homeland Security, shall review the adequacy of domestic 
vaccination and antimicrobial dispensing policy, guidance, 
and information provided to the public in light of any 
known terrorist risk of a biological attack or other phe-
nomena that may have serious health consequences for the 
United States, including wide-scale fatalities or infectious 
disease outbreaks. In carrying out the review under this sec-
tion, the Secretary shall consider— 
(1) material threat assessments and determina-
tions conducted by the Department of Homeland Se-
curity; 
(2) reports on global trends and intelligence pro-
duced by the Office of the Director of National Intel-
ligence and the Intelligence Community regarding bi-
ological threats; 
(3) the availability of domestic vaccine and 
antimicrobials to dispense to the public, on a vol-
untary basis, in anticipation of a biological attack; 
and 
(4) making surplus or expiring domestic vaccine 
and antimicrobials available to State, local, and trib-
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al emergency responders, including health care re-
sponders, on a voluntary basis. 
(b) REPORT.—Not later than one year after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall submit to the appropriate congres-
sional committees a report on the review required by sub-
section (a), together with any recommendations relating to 
the availability of domestic vaccine and antimicrobials for 
disbursing to the public and voluntary immunization by 
first responders. 
SEC. 304. DESIGNATION OF TIER 1 MATERIAL THREAT 
AGENTS. 
(a) PUBLIC HEALTH SERVICE ACT.—Section 351A of 
the Public Health Service Act (42 U.S.C. 262a) is amended 
in subsection (a)— 
(1) by redesignating paragraph (2) as para-
graph (3); 
(2) by inserting after paragraph (1) the fol-
lowing: 
‘‘(2) TIER I MATERIAL THREAT AGENTS.— 
‘‘(A) DESIGNATION
OF
TIER
I: MATERIAL 
THREAT AGENTS.—Not later than 1 year after 
the date of the enactment of this paragraph, the 
Secretary, in coordination with the Secretary of 
Homeland Security and other Federal officials 
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as appropriate, shall by regulation designate as 
‘Tier I Material Threat Agents’ those agents and 
toxins— 
‘‘(i) that— 
‘‘(I) are determined by the Sec-
retary of Homeland Security under 
section 319F-2(c)(2) to present a mate-
rial threat against the United States 
population sufficient to affect national 
security; and 
‘‘(II) are determined to warrant 
designation after applying the criteria 
in subparagraph (B); or 
‘‘(ii) that clearly present a material 
threat to the Nation as otherwise deter-
mined by the Secretary or the Secretary of 
Homeland Security. 
‘‘(B) CRITERIA.—In determining whether to 
designate an agent or toxin as a Tier I Material 
Threat Agent under subparagraph (A)(i), the 
Secretary, in coordination with the Secretary of 
Homeland Security, shall consider— 
‘‘(i) whether the agent or toxin can be 
used effectively in a biological attack; 
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‘‘(ii) information available from any 
biological or bioterrorism risk assessments 
conducted by the Department of Homeland 
Security and relevant assessments by other 
agencies; and 
‘‘(iii) such other criteria and informa-
tion as the Secretary, in coordination with 
the Secretary of Homeland Security, deter-
mines appropriate and relevant. 
‘‘(C) INCLUSION
OF
AGENTS
AND
TOXINS 
NOT PREVIOUSLY LISTED.—All agents or toxins 
designated by the Secretary as Tier I Material 
Threat Agents shall be included on the list main-
tained by the Secretary pursuant to paragraph 
(1). 
‘‘(D) EVALUATION
OF
TIER
I
MATERIAL 
THREAT AGENTS.—The Secretary, in coordina-
tion with the Secretary of Homeland Security, 
shall— 
‘‘(i) on an ongoing basis, consider the 
inclusion of additional agents or toxins on 
the list of Tier I Material Threat Agents, as 
appropriate; and 
‘‘(ii) at least biennially, review the list 
of Tier I Material Threat agents to deter-
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mine whether any agents or toxins should 
be removed from the list.’’; and 
(3) in paragraph (3), as so redesignated— 
(A) by striking ‘‘list under paragraph (1)’’ 
and inserting ‘‘lists under paragraphs (1) and 
(2)’’; and 
(B) by striking ‘‘revise the list’’ and insert-
ing ‘‘revise the lists’’. 
(b) AGRICULTURAL BIOTERRORISM PROTECTION ACT 
OF 2002.—Section 212(a) of the Agricultural Bioterrorism 
Protection Act of 2002 (7 U.S.C. 8401(a)) is amended— 
(1) by redesignating paragraph (2) as para-
graph (3); 
(2) by inserting after paragraph (1) the fol-
lowing: 
‘‘(2) TIER I MATERIAL THREAT AGENTS.— 
‘‘(A) DESIGNATION
OF
TIER
I: MATERIAL 
THREAT AGENTS.—Not later than one year after 
the date of the enactment of this paragraph, the 
Secretary, in coordination with the Secretary of 
Homeland Security, the Secretary of Health and 
Human Services, and other Federal officials as 
appropriate, shall by regulation designate as 
‘Tier I Material Threat Agents’ those agents and 
toxins— 
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‘‘(i) that— 
‘‘(I) are determined by the Sec-
retary of Homeland Security under 
section 319F-2(c)(2) of the Public 
Health Service Act to present a mate-
rial threat against the United States 
population sufficient to affect national 
security; and 
‘‘(II) are determined to warrant 
designation after applying the criteria 
in subparagraph (B); or 
‘‘(ii) that clearly present a material 
threat to the Nation as otherwise deter-
mined by the Secretary or the Secretary of 
Homeland Security. 
‘‘(B) CRITERIA.—In determining whether to 
designate an agent or toxin as a Tier I Material 
Threat Agent under subparagraph (A)(i), the 
Secretary, in coordination with the Secretary of 
Homeland Security, shall consider— 
‘‘(i) whether the agent or toxin can be 
used effectively in a biological attack; 
‘‘(ii) information available from any 
biological or bioterrorism risk assessments 
conducted by the Department of Homeland 
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(A) by striking ‘‘list under paragraph (1)’’ 
and inserting ‘‘lists under paragraphs (1) and 
(2)’’; and 
(B) by striking ‘‘revise the list’’ and insert-
ing ‘‘revise the lists’’. 
SEC. 305. BACKGROUND CHECKS. 
Section 351A(e)(3)(A) of the Public Health Service Act 
(42 U.S.C. 262a(e)(3)(A)) is amended by adding at the end 
the following: ‘‘In identifying whether an individual is 
within a category specified in subparagraph (B)(ii)(II), the 
Attorney General shall coordinate with the Secretary of 
Homeland Security, the Secretary of Defense, and the Sec-
retary of State to determine whether these officials possess 
any information relevant to the identification of such an 
individual by the Attorney General.’’. 
SEC. 306. BIOTECHNOLOGY RESEARCH, DEVELOPMENT, 
AND PROCUREMENT. 
Title III of the Public Health Service Act is amended 
by inserting after section 319M (42 U.S.C. 247d–f) the fol-
lowing: 
‘‘SEC. 319N. BIOTECHNOLOGY RESEARCH, DEVELOPMENT, 
AND PROCUREMENT. 
‘‘(a) IN GENERAL.—The Secretary shall develop a 
comprehensive research, development, and acquisition proc-
ess to counter the biological threat that employs the inherent 
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functions, capabilities, authorities, and responsibilities of 
NIH, BARDA, and Project BioShield. The process shall— 
‘‘(1) assign NIH responsibility for research and 
development of technologies that range in development 
from basic principles observed and reported up to 
model or prototype demonstration in a relevant envi-
ronment; 
‘‘(2) assign BARDA responsibility for research 
and development of technologies that range in devel-
opment from model or prototype demonstration in a 
relevant environment up to a system qualified for ap-
plication through successful test and demonstration; 
‘‘(3) assign Project BioShield responsibility for 
procurement of technologies that— 
‘‘(A) are qualified for application through 
successful test and demonstration; and 
‘‘(B) meet the minimum statutory require-
ments for emergency use authorization in section 
564 of the Federal Food, Drug, and Cosmetic 
Act; and 
‘‘(4) include a formal agreement among NIH, 
BARDA, and Project BioShield that— 
‘‘(A) identifies the need for any specific bio-
logical countermeasure, derived from information 
developed under section 319F–2; 
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‘‘(B) identifies the current technology readi-
ness level of the countermeasure; and 
‘‘(C) requires the development of the biologi-
cal countermeasure from the current technology 
readiness level through the procurement of the 
countermeasure in accordance with paragraph 
(3). 
‘‘(b) RESPONSIBILITY OF NIH.—For countermeasures 
identified under subsection (a)(4)(A) that have a level of 
development from basic principles observed and reported up 
to model or prototype demonstration in a relevant environ-
ment, the Director of NIH shall conduct research and devel-
opment until the Director certifies to the Secretary of 
Health and Human Services that— 
‘‘(1) the countermeasure has completed model or 
prototype demonstration in a relevant environment; 
or 
‘‘(2) the Director does not believe that completion 
of model or prototype demonstration in a relevant en-
vironment is reasonably achievable. 
‘‘(c) RESPONSIBILITY
OF
BARDA.—For counter-
measures identified under subsection (a)(4)(A) that have a 
level of development of model or prototype demonstration 
in a relevant environment, including but not limited to 
those countermeasures certified to have that level of develop-
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ment by the Director of NIH, the Director of BARDA shall 
conduct research and development until the Director of 
BARDA certifies to the Secretary of Health and Human 
Services that— 
‘‘(1) the countermeasure has qualified for appli-
cation through successful test and demonstration; or 
‘‘(2) the Director does not believe that qualifica-
tion for application through successful test and dem-
onstration is reasonably achievable. 
‘‘(d) RESPONSIBILITY OF PROJECT BIOSHIELD.—For 
countermeasures identified under subsection (a)(4)(A) that 
are qualified for application through successful test and 
demonstration, including but not limited to those counter-
measures certified to have qualified for application through 
successful test and demonstration by the Director of 
BARDA, the Assistant Secretary of Health and Human 
Services for Preparedness and Response shall use the Project 
BioShield special reserve fund to may procure the counter-
measure if the countermeasure meets the requirements for 
emergency use authorization described in subsection 
(a)(3)(B). 
‘‘(e) NO REQUIREMENT FOR FOOD AND DRUG ADMIN-
ISTRATION GENERAL USE APPROVAL.—The Secretary shall 
ensure that the Directors of NIH and BARDA and the As-
sistant Secretary of Health and Human Services for Pre-
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paredness and Response do not discontinue any research, 
development, or procurement of a countermeasure identified 
under subsection (a)(4)(A) because the Food and Drug Ad-
ministration has not, or decides against, approving or li-
censing the countermeasure for general use under chapter 
V of the Federal Food, Drug, and Cosmetic Act or section 
351 of this Act, as applicable. 
‘‘(f) INNOVATION.—The Secretary shall require the Di-
rectors of NIH and BARDA and the Assistant Secretary 
of Health and Human Services for Preparedness and Re-
sponse to aggressively pursue innovative research, develop-
ment, and procurement of each countermeasure identified 
under subsection (a)(4)(A). 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) The term ‘BARDA’ means the he Bio-
medical Advanced Research and Development Author-
ity established under section 319L(c). 
‘‘(2) The term ‘NIH’ means the National Insti-
tutes of Health. 
‘‘(3) The term ‘Project Bioshield’ means the Fed-
eral medical countermeasure procurement program es-
tablished by Public Law 108–276.’’. 
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TITLE IV—FOREIGN RELATIONS 
MATTERS 
SEC. 401. INTERNATIONAL COLLABORATION AND INFORMA-
TION SHARING RELATING TO BIOSECURITY. 
The Secretary of State, in coordination with the Sec-
retary of Homeland Security, the Secretary of Agriculture, 
the Secretary of Health and Human Services, and the heads 
of other appropriate Federal agencies, shall— 
(1) support efforts in other countries and regions 
to develop mechanisms and capabilities for reporting 
to United Nations organizations validated data on bi-
ological attacks or other phenomena that may have se-
rious health consequences for the United States, in-
cluding wide-scale fatalities or infectious disease out-
breaks; 
(2) engage other Federal and nongovernmental 
entities and other countries to advance awareness and 
understanding of the risk posed by information de-
rived from the life sciences that has the potential for 
misuse to cause harm, and advance recommendations 
on how best to address such risk; 
(3) engage such entities and countries to promote 
greater awareness and understanding of the global 
availability of and access to life science technologies 
and materials; and 
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(4) promote the development and use of mecha-
nisms for reporting, preserving, and sharing data on 
Federal programs and investments in international 
scientific, agricultural, medical, and public health 
collaborations in support of efforts to enhance global 
biosecurity. 
SEC. 402. INTERNATIONAL ENGAGEMENT TO ENHANCE BIO-
DEFENSE AND BIOSECURITY. 
The Secretary of State, in coordination and consulta-
tion with the Secretary of Homeland Security, and the 
heads other appropriate Federal agencies, shall, as appro-
priate— 
(1) support efforts of other countries to establish 
and build capacity to effectively implement legislation 
criminalizing the development or use of biological 
weapons or acts of bioterrorism; 
(2) engage other countries and international 
nongovernmental entities to develop and establish 
common standards, guidance, and best practices for 
actions relevant to preventing acts of bioterrorism 
and the illicit use of life sciences; 
(3) support the efforts of other countries to en-
hance biosecurity and safety practices at laboratories 
and other facilities with materials that could be used 
in biological weapons or in an act of bioterrorism; 
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(4) promote the development and adoption of 
international guidance for the safety and security of 
high-risk pathogens and toxins; and 
(5) promote information sharing relating to 
threats and best practices between the intelligence 
community, Federal law enforcement, and inter-
national law enforcement and security officials. 
SEC. 403. INTERAGENCY TASK FORCE ON BEST PRACTICES 
FOR GLOBAL BIOPREPAREDNESS. 
(a) SENSE OF CONGRESS.—It is the sense of Congress 
that preparedness for a chemical, biological, radiological, 
or nuclear incident must be undertaken not only domesti-
cally but also internationally. Specifically, there is a need 
for a global preparedness architecture for such an event. 
Congress supports efforts to provide an international forum 
for discussion of key health security policies with inter-
national dimensions, and the establishment of a formal 
United States interagency task force to develop best prac-
tices and recommendations for implementation of a global 
preparedness architecture could enhance global prepared-
ness. 
(b) ESTABLISHMENT OF TASK FORCE.—The Secretary 
of State shall convene and lead an interagency task force 
to examine— 
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(1) the state of global biopreparedness for a 
major biological event; 
(2) necessary components of a global bio-
preparedness architecture that would advance inter-
national health security, including considerations 
of— 
(A) risk assessments; 
(B) prevention and deterrence; 
(C) detection; 
(D) regional stockpiling of medical counter-
measures, including considerations of— 
(i) security of the stockpile; 
(ii) delivery planning; and 
(iii) legal dimensions of and obstacles 
to implementing such an architecture; 
(E) attribution; 
(F) response; 
(G) other elements that should be a compo-
nent of such an architecture; and 
(H) obstacles to implementing such an ar-
chitecture; 
(3) best practices for preparedness based on les-
sons learned from domestic efforts to address the above 
issues, and that may be applicable internationally; 
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(4) activities undertaken through the National 
Strategy for Countering Biological Threats and the 
International Health Regulations 2005, as well as 
other activities deemed relevant by the task force; and 
(5) the utility of working through existing inter-
national forums as a mechanism for distributing this 
information to the international community. 
(c) MEMBERSHIP.—Members of the task force shall in-
clude representatives from— 
(1) the Department of Homeland Security; 
(2) the Department of Health and Human Serv-
ices, including the Centers for Disease Control and 
Prevention; 
(3) the Department of Agriculture; 
(4) the Department of Defense; 
(5) the Department of Justice; 
(6) the Department of State; 
(7) the United States Agency for International 
Development; 
(8) the Director of National Intelligence; 
(9) other Federal Departments and agencies, as 
determined appropriate by the Secretary; and 
(10) other national biosecurity and biodefense 
stakeholders, including private sector, including the 
pharmaceutical industry and the biological laboratory 
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community, as determined appropriate by the Sec-
retary. 
(d) REPORT.—Not later than 18 months after the date 
of the enactment of this Act, the Secretary shall submit to 
the appropriate congressional committees a report on the 
findings of the task force established under this section. 
SEC. 404. BIOLOGICAL AND TOXIN WEAPONS CONVENTION. 
The Secretary of State shall— 
(1) promote confidence in effective implementa-
tion of and compliance with the Convention on the 
Prohibition of the Development, Production and 
Stockpiling of Bacteriological (Biological) and Toxin 
Weapons and on their Destruction (commonly re-
ferred to as the ‘‘Biological and Toxin Weapons Con-
vention’’) by the States party to the Convention by 
promoting transparency with respect to legitimate ac-
tivities and pursuing compliance diplomatically to 
address concerns; 
(2) promote universal membership in the Con-
vention; 
(3) develop an action plan for increasing inter-
national adherence to the Convention; and 
(4) ensure that United States participation in 
Convention meetings is broadly inclusive of represent-
atives of relevant Federal departments and agencies. 
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