‘‘(1) TAILORED
RISK
ASSESSMENT.—The Sec-
retary, acting through the Under Secretary for 
Science and Technology and in coordination with the 
Administrator of the Environmental Protection Agen-
cy, shall conduct tailored risk assessments to inform 
prioritization of national recovery activities for chem-
ical, biological, radiological, and nuclear incidents, to 
be updated as necessary. 
‘‘(2) CONSIDERATIONS.—In conducting the risk 
assessments under paragraph (1), the Secretary 
shall— 
‘‘(A) consult with the Secretary of Health 
and Human Services, the Secretary of Agri-
culture, the Secretary of the Interior, the Chair-
man of the Nuclear Regulatory Commission, and 
the heads of other relevant Federal departments 
and agencies; 
‘‘(B) consider recovery of both indoor areas 
and outdoor environments; and 
‘‘(C) consider relevant studies previously 
prepared by other Federal agencies, or other ap-
propriate stakeholders. 
‘‘(3) COLLABORATION.—Upon completion of the 
risk assessments required by this section, the Sec-
retary shall provide the findings to the Administrator 
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of the Environmental Protection Agency and heads of 
other relevant Federal agencies in order to inform on-
going and future work, including research and guid-
ance development, undertaken by those agencies in re-
covery and remediation from chemical, biological, ra-
diological, or nuclear incidents. 
‘‘(b) RESEARCH.—The results of the risk assessment 
under this section shall inform appropriate Federal re-
search to address the high-risk capability gaps uncovered 
by each assessment. 
‘‘(c) SUBMISSION TO CONGRESS.—The results of each 
risk assessment shall be submitted to the appropriate con-
gressional committees within 30 days after completion of 
the assessment. 
‘‘SEC. 2142. RECOVERY FROM A CHEMICAL, BIOLOGICAL, RA-
DIOLOGICAL, AND NUCLEAR ATTACK OR INCI-
DENT. 
‘‘(a) ESTABLISHMENT OF GUIDANCE.—The Secretary 
shall develop and issue guidance for clean-up and restora-
tion of indoor and outdoor areas, including subways and 
other mass transportation facilities, that have been exposed 
to chemical, biological, radiological, or nuclear materials. 
The Secretary shall develop and issue the guidance, within 
24 months after the date of enactment of this section, in 
consultation with— 
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‘‘(1) the Secretary of Agriculture; 
‘‘(2) the Secretary of Commerce; 
‘‘(3) the Secretary of Education; 
‘‘(4) the Secretary of the Interior; 
‘‘(5) the Attorney General; 
‘‘(6) the Secretary of Labor; 
‘‘(7) the Secretary of Transportation; 
‘‘(8) the Secretary of Housing and Urban Devel-
opment; 
‘‘(9) the Secretary of Health and Human Serv-
ices; 
‘‘(10) the Secretary of Veterans Affairs; 
‘‘(11) the Secretary of the Treasury; 
‘‘(12) the Administrator of the Environmental 
Protection Agency; and 
‘‘(13) the Administrator of the Small Business 
Administration. 
‘‘(b) CONTENTS.—The guidance developed under sub-
section (a) shall clarify Federal roles and responsibilities 
for assisting State, local, and tribal authorities and include 
risk-based recommendations for— 
‘‘(1) standards for effective decontamination of 
affected sites; 
‘‘(2) standards for safe post-event occupancy of 
affected sites, including for vulnerable populations 
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such as children and individuals with health con-
cerns; 
‘‘(3) requirements to ensure that the decon-
tamination procedures for responding organizations 
do not conflict; 
‘‘(4) requirements that each responding organi-
zation uses a uniform system for tracking costs and 
performance of clean-up contractors; 
‘‘(5) maintenance of negative air pressure in 
buildings; 
‘‘(6) standards for proper selection and use of 
personal protective equipment; 
‘‘(7) air sampling procedures; 
‘‘(8) development of occupational health and 
safety plans that are appropriate for the specific risk 
to responder health; and 
‘‘(9) waste disposal. 
‘‘(c) REVIEW AND REVISION OF GUIDANCE.—The Sec-
retary shall— 
‘‘(1) not less frequently than once every 2 years, 
review the guidance developed under subsection (a); 
‘‘(2) make revisions to the guidance as appro-
priate; and 
‘‘(3) make the revised guidance available to the 
Federal Government, State, local, and tribal authori-
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ties, nongovernmental organizations, the private sec-
tor, 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) prioritize issuance of guidance based on the 
results of the risk assessment under section 2131; 
‘‘(2) inventory existing relevant guidance; 
‘‘(3) enable the public to submit recommenda-
tions of areas in which guidance is needed; 
‘‘(4) determine which entities should be consulted 
in developing or revising the guidance; 
‘‘(5) prioritize, on a regular basis, guidance that 
should be developed or revised; and 
‘‘(6) develop and disseminate the guidance in ac-
cordance with the prioritization under paragraph (5). 
‘‘(e) CONSULTATIONS.—The Secretary shall develop 
and revise the guidance developed under subsection (a), and 
the procedures required under subsection (d), in consulta-
tion with— 
‘‘(1) the heads of other Federal departments and 
agencies that are not required to be consulted under 
subsection (a), as the Secretary considers appropriate; 
‘‘(2) State, local, and tribal authorities; and 
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‘‘(3) nongovernmental organizations and private 
industry. 
‘‘(f) REPORT.—Not later than 1 year after the date of 
the enactment of this section, and annually thereafter, the 
Secretary shall provide appropriate congressional commit-
tees 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) was disseminated; 
‘‘(4) a plan for reviewing the guidance described 
in paragraph (2), in accordance with subsection (e); 
‘‘(5) the prioritized list of the guidance required 
under subsection (d)(4), and the methodology used by 
the Secretary for such prioritization; and 
‘‘(6) a plan for developing, revising, and dis-
seminating the guidance. 
‘‘SEC. 2143. EXERCISES. 
‘‘(a) IN GENERAL.—To facilitate recovery from a 
chemical, biological, radiological, or nuclear attack or other 
incident involving chemical, biological, radiological, or nu-
clear materials and to foster collective response to terrorism, 
the Secretary shall develop exercises in consultation with 
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State, local, and tribal authorities and other appropriate 
Federal agencies, and, as appropriate, in collaboration with 
national level exercises, including exercises that address, to 
the best knowledge available at the time, analysis, indoor 
environmental cleanup methods, and decontamination 
standards, including those published in the guidance issued 
under section 2142. 
‘‘(b) LESSONS LEARNED FOR NATIONAL LEVEL EXER-
CISES.—The Secretary shall provide electronically, to the 
maximum extent practicable, lessons learned reports to each 
designated representative of State, local, and tribal jurisdic-
tions and private sector entities that participate in Na-
tional Level Exercises of the Department. Each lessons 
learned report shall be tailored to convey information on 
that exercise that could be leveraged to enhance prepared-
ness and response.’’. 
(b) CLERICAL AMENDMENT.—The table of contents in 
section 1(b) of such Act is amended by adding at the end 
the following new items: 
‘‘TITLE XXI—WEAPONS OF MASS DESTRUCTION PREVENTION AND 
PREPAREDNESS 
‘‘Subtitle A—Prevention 
‘‘Sec. 2101. Weapons of mass destruction intelligence and information sharing. 
‘‘Sec. 2102. Risk assessments. 
‘‘Sec. 2103. National Export Enforcement Coordination. 
‘‘Sec. 2104. Communication of threat information. 
‘‘Sec. 2105. Individual and community preparedness for chemical, biological, ra-
diological, and nuclear attacks. 
‘‘Subtitle B—Protection 
‘‘Sec. 2121. Detection of biological attacks. 
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‘‘Sec. 2122. Rapid biological threat detection and identification at ports of entry. 
‘‘Sec. 2123. Evaluating detection technology. 
‘‘Sec. 2124. Domestic implementation of the Global Nuclear Detection Architec-
ture. 
‘‘Subtitle C—Response 
‘‘Sec. 2131. First responder guidance concerning chemical, biological, radio-
logical, and nuclear attacks. 
‘‘Sec. 2132. Integrated plume modeling for collective response. 
‘‘Sec. 2133. Establishment of the system assessment and validation for emergency 
responders (SAVER) program. 
‘‘Sec. 2134. Payment for laboratory response services. 
‘‘Sec. 2135. Bioforensics capabilities. 
‘‘Sec. 2136. Metropolitan Medical Response System Program. 
‘‘Subtitle D—Recovery 
‘‘Sec. 2141. Identifying and addressing gaps in recovery capabilities. 
‘‘Sec. 2142. Recovery from a chemical, biological, radiological, and nuclear attack 
or incident. 
‘‘Sec. 2143. Exercises.’’. 
(c) CONFORMING AMENDMENT.—Section 316 of the 
Homeland Security Act of 2002 (6 U.S.C. 195b), and the 
item relating to such section in section 1(b) of such Act, 
are repealed. 
(d) METROPOLITAN MEDICAL RESPONSE PROGRAM 
REVIEW.— 
(1) IN GENERAL.—The Administrator of the Fed-
eral Emergency Management Agency, the Chief Med-
ical Officer of the Department of Homeland Security, 
and the National Metropolitan Medical Response Sys-
tem Working Group shall conduct a review of the 
Metropolitan Medical Response System Program au-
thorized under section 2136 of the Homeland Security 
Act of 2002, as added by this section, including an 
examination of— 
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(A) the extent to which the program goals 
and objectives are being met; 
(B) the performance metrics that can best 
help assess whether the Metropolitan Medical Re-
sponse System Program is succeeding; 
(C) how the Metropolitan Medical Response 
System Program can be improved; 
(D) how the Metropolitan Medical Response 
System Program complements and enhances 
other preparedness programs supported by the 
Department of Homeland Security and the De-
partment of Health and Human Services; 
(E) the degree to which the strategic goals, 
objectives, and capabilities of the Metropolitan 
Medical Response System Program are incor-
porated in State and local homeland security 
plans; 
(F) how eligibility for financial assistance, 
and the allocation of financial assistance, under 
the Metropolitan Medical Response System Pro-
gram should be determined, including how allo-
cation of assistance could be based on risk; 
(G) implications for the Metropolitan Med-
ical Response System Program if it were man-
aged as a contractual agreement; and 
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(H) the resource requirements of the Metro-
politan Medical Response System Program. 
(2) REPORT.—Not later than 1 year after the 
date of enactment of this Act, the Administrator and 
the Chief Medical Officer shall submit to the Com-
mittee on Homeland Security of the House of Rep-
resentatives and the Committee on Homeland Secu-
rity and Governmental Affairs of the Senate a report 
on the results of the review under this section. 
(3) CONSULTATION.—The Administrator of the 
Federal Emergency Management Agency shall consult 
with the Secretary of Health and Human Services in 
the implementation of paragraph (1)(E). 
(4) DEFINITION.—In this subsection the term 
‘‘National Metropolitan Medical Response System 
Working Group’’ has the meaning that term has in 
section 2136 of the Homeland Security Act of 2002, 
as added by this section. 
SEC. 302. ENHANCING LABORATORY BIOSECURITY. 
(a) 
FEDERAL
EXPERTS
SECURITY
ADVISORY 
PANEL.— 
(1) PANEL.— 
(A) ESTABLISHMENT.—The President shall 
establish a permanent advisory panel to be 
known as the Federal Experts Security Advisory 
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Panel to make technical and substantive rec-
ommendations on biological agent and toxin se-
curity. 
(B) MEMBERSHIP.—The members of the 
Panel— 
(i) shall consist of the voting members 
appointed under subparagraph (D) and the 
nonvoting members appointed under sub-
paragraph (E); and 
(ii) except as provided in subpara-
graph (E), shall each be an official or em-
ployee of the Federal Government. 
(C) CO-CHAIRS.—The voting members of the 
Panel appointed under clauses (i), (v), and (vi) 
of subparagraph (D) shall serve jointly as the 
Co-Chairs of the Panel. 
(D) VOTING MEMBERS.—The voting mem-
bers of the Panel shall consist of 1 voting rep-
resentative of each of the following Government 
entities, appointed (except with respect to the 
National Security Council) by the head of the re-
spective entity: 
(i) The Department of Agriculture. 
(ii) The Department of Commerce. 
(iii) The Department of Defense. 
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(iv) The Department of Energy. 
(v) The Department of Health and 
Human Services. 
(vi) The Department of Homeland Se-
curity. 
(vii) The Department of Justice. 
(viii) The Department of Labor. 
(ix) The Department of State. 
(x) The Department of Transportation. 
(xi) The Department of Veterans Af-
fairs. 
(xii) The Environmental Protection 
Agency. 
(xiii) The National Security Council, 
which shall be represented by the Special 
Assistant to the President for Biodefense. 
(xiv) The Office of the Director of Na-
tional Intelligence. 
(xv) Any other department or agency 
designated by the Co-Chairs. 
(E) NONVOTING MEMBERS.—The nonvoting 
members of the Panel shall consist of— 
(i) such additional representatives of 
the Government entities listed in subpara-
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graph (D) as may be appointed by the 
heads of the respective entities; and 
(ii) a representative of the public 
health laboratory community or biological 
laboratory community (or both). 
(F) ADMINISTRATIVE SUPPORT.—The Sec-
retary of Health and Human Services shall pro-
vide to the Panel such facilities, staff, and sup-
port services as may be necessary for the Panel 
to carry out its responsibilities under paragraph 
(2). 
(2) 
RESPONSIBILITIES.—Not 
later 
than 
months after the date of the enactment of this section, 
the Panel shall, with respect to biological agent and 
toxin security, deliver to the Secretaries of Agri-
culture, Health and Human Services, and Homeland 
Security plurality recommendations, including any 
statements of dissent, concerning— 
(A) the designation as highest risk of that 
subset of biological agents and toxins listed pur-
suant to section 351A(a)(1) of the Public Health 
Service Act (42 U.S.C. 262a(a)(1)) that presents 
the greatest risk of deliberate misuse with signifi-
cant potential for mass casualties or devastating 
effects to the economy, informed by— 
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(i) any biological or bioterrorism risk 
assessments conducted by the Department of 
Homeland Security and relevant assess-
ments by other agencies; and 
(ii) determinations made by the Sec-
retary of Homeland Security pursuant to 
section 319F–2(c)(2)(A) of such Act (42 
U.S.C. 247d–6b(c)(2)(A)); 
(B) the development of a set of minimum 
risk-based prescriptive laboratory security per-
formance standards based on the risk at the low-
est level, allowing for enhancements as risk in-
creases; 
(C) the establishment of appropriate stand-
ards and practices to improve vetting and moni-
toring of, and ensure reliability of, personnel 
with access to highest risk biological agents and 
toxins at facilities registered under section 
351A(d) of the Public Health Service Act (42 
U.S.C. 262a(d)); 
(D) the establishment of appropriate prac-
tices for physical security and cyber security for 
facilities that possess highest risk biological 
agents or toxins; 
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(E) standards for training of laboratory 
personnel in security measures; 
(F) other emerging policy issues relevant to 
the security of biological agents and toxins; 
(G) adequacy of information sharing proto-
cols with biodefense and biosecurity stakeholders; 
and 
(H) any other security standards deter-
mined necessary. 
(b) REVISION OF RULES AND REGULATIONS.— 
(1) PROPOSED
RULES.—The Secretaries of 
Health and Human Services and Agriculture, in co-
ordination with the Secretary of Homeland Security, 
no later than 1 year after the date of receipt of rec-
ommendations under subsection (a)(2), shall, as ap-
propriate, propose rules under section 351A of the 
Public Health Service Act (42 U.S.C. 262a) estab-
lishing security standards and procedures that are 
specific to highest risk biological agents and toxins. 
(2) FINAL
RULES.—The Secretaries of Health 
and Human Services and Agriculture, in coordina-
tion with the Secretary of Homeland Security, no 
later than 24 months after the date of the enactment 
of this section, shall promulgate final rules described 
in paragraph (1). 
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(c) COORDINATION OF FEDERAL OVERSIGHT.—To en-
sure that the Federal Government provides for comprehen-
sive and effective oversight of biological agents and toxins 
security, the heads of the Government entities listed in sub-
section (a)(1)(D) shall for facilities in which the entity sup-
ports biological agent or toxin laboratory activities and by 
no later than 6 months after the submission of recommenda-
tions under subsection (a)(2), develop and implement a 
plan for the coordination of biological agents and toxins 
security oversight that— 
(1) articulates a mechanism for coordinated in-
spections of and harmonized administrative practices 
for facilities registered under section 351A(d) of the 
Public Health Service Act (42 U.S.C. 262a(d)), pur-
suant to subsection (d) of this section; and 
(2) ensures consistent and timely identification 
and resolution of biological agents and toxins security 
and compliance issues. 
(d) COMMON INSPECTION PROCEDURES.—The heads of 
the entities listed in subsection (a)(1)(D) shall coordinate 
or consolidate laboratory inspections and ensure that such 
inspections are conducted using a common set of inspection 
procedures across such entities in order to minimize the ad-
ministrative burden on such laboratory. 
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(e) INSPECTION REPORTS.—Any inspection report re-
sulting from an inspection described in paragraph (1) shall 
be available to— 
(1) each Federal agency that supports biological 
agent or toxin laboratory activities at the laboratory 
that is the subject of the inspection report; and 
(2) the laboratories that are the object of inspec-
tion. 
(f) LABORATORY BIOSECURITY INFORMATION SHAR-
ING.— 
(1) FEDERAL
SHARING.—The Secretaries of 
Health and Human Services and Agriculture shall— 
(A) develop a process for sharing of infor-
mation pertaining to biological agents and tox-
ins with agencies that support biological agent 
or toxin laboratory activities, that identifies the 
purpose for sharing, and a mechanism for secur-
ing, such information; 
(B) share relevant information pertaining 
to biological agents and toxins, including identi-
fication of laboratories possessing highest risk bi-
ological agents and toxins, and compliance issues 
with the Secretary of Homeland Security; and 
(C) share relevant information pertaining 
to biological agents and toxins, including identi-
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fication of laboratories possessing highest risk bi-
ological agents and toxins, with appropriate 
State, local, and tribal government authorities, 
including law enforcement authorities and emer-
gency response providers. 
(2) CLASSIFIED AND SENSITIVE INFORMATION.— 
The Secretaries of Agriculture and Health and 
Human Services shall ensure that any information 
disseminated under this section is handled consist-
ently with— 
(A) the authority of the Director of National 
Intelligence to protect intelligence sources and 
methods under the National Security Act of 1947 
(50 U.S.C. 401 et seq.) and related procedures or 
similar authorities of the Attorney General con-
cerning sensitive law enforcement information; 
(B) section 552a of title 5, United States 
Code (commonly referred to as the ‘‘Privacy Act 
of 1974’’); and 
(C) other relevant laws. 
(g) DEFINITIONS.—In this section: 
(1) The terms ‘‘biological agent’’ and ‘‘toxin’’ 
refer to a biological agent or toxin, respectively, listed 
pursuant to section 351A(a)(1) of the Public Health 
Service Act (42 U.S.C. 262(a)(1)). 
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(2) The term ‘‘highest risk’’ means, with respect 
to a biological agent or toxin, designated as highest 
risk as described in subsection (a)(2)(A). 
(3) The term ‘‘Panel’’ means the Federal Experts 
Security Advisory Panel under subsection (a). 
(4) The term ‘‘State, local, and tribal’’ has the 
same meaning that term has in the Homeland Secu-
rity Act of 2002 (6 U.S.C. 101 et seq.). 
SEC. 303. DEFINITIONS. 
Section 2 of the Homeland Security Act of 2002 (6 
U.S.C. 101) is amended by adding at the end the following 
new paragraphs: 
‘‘(19) The term ‘Intelligence Community’ has the 
meaning given that term in section 3(4) of the Na-
tional Security Act of 1947 (50 U.S.C. 401a(4)). 
‘‘(20) 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, protect against, respond to, and recover from 
a biological attack or other biological incidents that 
may have serious health or economic consequences for 
the United States, including wide-scale fatalities or 
infectious disease outbreaks.’’. 
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SEC. 304. DUAL-USE TERRORIST RISKS FROM SYNTHETIC 
BIOLOGY. 
(a) SENSE OF CONGRESS.—It is the sense of Congress 
that the field of synthetic biology has the potential to facili-
tate enormous gains in fundamental discovery, public 
health, and biotechnological applications, but that it also 
presents inherent dual-use homeland security risks that 
must be managed. 
(b) ASSESSMENT OF RISK.—Not less frequently than 
once every two years, the Secretary of Homeland Security, 
acting through the Under Secretary for Science and Tech-
nology, shall undertake a risk assessment of the dual-use 
and other risks associated with synthetic biology. 
(c) ESTABLISHMENT OF GUIDANCE.—Not later than 
six months after the date of the enactment of this Act, the 
Secretary shall develop and provide to the heads of all de-
partments and agencies that fund life sciences research, 
guidance on compliance with United States laws, arms con-
trol agreements to which the United States is a party or 
signatory, and individual department and agency policy, 
including consideration of— 
(1) best practices for establishing a department 
or agency process that achieves compliance for depart-
ment or agency research, development, or acquisition 
projects in the life sciences; 
(2) the types of projects that should be assessed; 
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(3) at what stage or stages such projects should 
be assessed; and 
(4) means for preventing the release of homeland 
or national security information. 
(d) RESEARCH AND DEVELOPMENT.—Based upon the 
findings of the risk assessment undertaken in accordance 
with subsection (b), the Under Secretary may conduct re-
search into the risks and ways to mitigate such risks of syn-
thetic biology, 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 such risk assessment. 
SEC. 305. DISSEMINATION OF INFORMATION ANALYZED BY 
THE DEPARTMENT TO STATE, LOCAL, TRIBAL, 
AND PRIVATE ENTITIES WITH RESPONSIBIL-
ITIES RELATING TO HOMELAND SECURITY. 
Section 201(d)(8) of the Homeland Security Act of 
2002 (6 U.S.C. 121(d)(8)) is amended by striking ‘‘and to 
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agencies of State’’ and all that follows and inserting ‘‘to 
State, local, tribal, and private entities with such respon-
sibilities, and, as appropriate, to the public, in order to 
assist in preventing, deterring, or responding to acts of ter-
rorism against the United States.’’. 
TITLE IV—PUBLIC HEALTH 
MATTERS 
SEC. 401. SENSE OF CONGRESS REGARDING FEDERAL CO-
ORDINATION 
ON 
MEDICAL 
COUNTER-
MEASURES. 
It is the sense of Congress that— 
(1) 10 years after the terrorist attacks of Sep-
tember 11, 2001, and 7 years after enactment of the 
Project BioShield Act of 2004 (Public Law 108–276), 
coordination among Federal agencies involved in ac-
tivities relating to researching, developing, and ac-
quiring medical countermeasures still needs improve-
ment; and 
(2) aggressive action should be taken by the De-
partment of Health and Human Services (in par-
ticular, the heads of the National Institutes of Health, 
the Biomedical Advanced Research and Development 
Authority, the Centers for Disease Control and Pre-
vention, and the Food and Drug Administration), the 
Department of Homeland Security, and the Depart-
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ment of Defense to foster greater coordination with re-
spect to such activities, including adoption of an 
interagency agreement that sets forth the relative 
areas of responsibility with respect to establishing 
medical countermeasure requirements and research-
ing, developing, and acquiring medical counter-
measures to meet those requirements. 
SEC. 402. 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.— 
‘‘(1) IN GENERAL.—The Secretary, in coordina-
tion with the Secretary of Homeland Security, the 
Secretary of Agriculture, and other appropriate Fed-
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eral agencies, shall develop, implement, and, as ap-
propriate, periodically update a National Medical 
Countermeasure Dispensing Strategy to enhance pre-
paredness and collective response to a terrorist attack 
on humans or animals with any chemical, biological, 
radiological, or nuclear material, that delineates Fed-
eral, State, and local responsibilities. 
‘‘(2) CONSIDERATIONS.—The strategy shall be 
sufficiently flexible to meet the unique needs of dif-
ferent communities, including first responders, and 
shall consider— 
‘‘(A) a variety of options for dispensing 
medical countermeasures, including to individ-
uals, schools, universities, hospitals, and elderly 
care facilities; 
‘‘(B) post-incident requirements for emer-
gency use authorizations before countermeasures 
can be distributed legally; 
‘‘(C) the inclusion of locally held caches of 
countermeasures in event-specific authorizations 
covering federally held countermeasures of the 
same type; and 
‘‘(D) distribution to the public of home 
medical kits for personal stockpiling purposes, 
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within 30 days after a domestic or international 
bioterrorist attack resulting in human infection. 
‘‘(c) COORDINATION.—The Secretary shall coordinate 
with the Administrator of the Federal Emergency Manage-
ment Agency, State, local, and tribal authorities, represent-
atives from the private sector, and nongovernmental organi-
zations on the National Medical Countermeasures Dis-
pensing Strategy. 
‘‘(d) REPORT.—Not later than 1 year after the date 
of the enactment of this section, the Secretary shall submit 
the National Medical Countermeasures Dispensing Strategy 
to the appropriate congressional committees.’’. 
SEC. 403. NATIONAL PRE-EVENT VACCINATION AND ANTI-
MICROBIAL DISPENSING POLICY REVIEW. 
(a) REQUIREMENT.—The Secretary of Health and 
Human Services, in coordination with the Secretary of 
Homeland Security and the Secretary of Agriculture, shall 
review the adequacy of domestic vaccination and anti-
microbial dispensing policy, guidance, and information 
provided to the public in light of any known terrorist risk 
of a biological attack or other phenomena that may have 
serious health consequences for the United States, including 
wide-scale fatalities or infectious disease outbreaks includ-
ing outbreaks associated with the avian flu. In carrying out 
the review under this section, the Secretary shall consider— 
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(1) terrorism risk assessments under section 2102 
of the Homeland Security Act of 2002, as amended by 
this Act, and material threat assessments and deter-
minations under the Project Bioshield Act of 2004 
(Public Law 108–276) and the amendments made by 
that Act; 
(2) reports on global trends and intelligence pro-
duced by the Office of the Director of National Intel-
ligence and the Intelligence Community regarding bi-
ological threats; 
(3) the availability of federally provided vaccines 
and antimicrobials to dispense to first responders and 
the public, on a voluntary basis, in anticipation of a 
biological attack; 
(4) applicability of Federal shelf-life extension 
programs to locally held stockpiles of medical counter-
measures, to the extent that information on local 
stockpiles is available; 
(5) making expiring products available to appro-
priate international organizations or foreign partners 
once the requests of domestic stakeholders have been 
fulfilled; 
(6) the implications of pre-event vaccination and 
antimicrobial dispensing to livestock; and 
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(7) mechanisms to increase coordination between 
the Strategic National Stockpile established under sec-
tion 319F–2 of the Public Health Service Act (42 
U.S.C. 247D–6b) and the National Veterinary Stock-
pile that would enhance vaccination and dispensing 
capabilities. 
(b) REPORT.—Not later than 1 year after the date of 
the enactment of this Act, the Secretary of Health and 
Human Services shall report to the appropriate congres-
sional committees on the review required by subsection (a), 
together with any recommendations relating to the avail-
ability of domestic vaccine and antimicrobials for dis-
bursing to the public and voluntary immunization by first 
responders. 
SEC. 404. MANAGEMENT OF SHORT SHELF LIFE VACCINE 
AND ANTIMICROBIAL STOCKPILES. 
The Secretary of Health and Human Services shall 
make available surplus vaccines and antimicrobials, and 
vaccines and antimicrobials with short shelf lives, from the 
strategic national stockpile under section 319F–2(a) of the 
Public Health Service Act (42 U.S.C. 247d–6b(a)) to State, 
local, and tribal first responders, including health care re-
sponders, for administration to such responders who volun-
tarily consent to such administration, and shall— 
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(1) establish any necessary logistical and track-
ing systems to facilitate making such vaccines and 
antimicrobials so available; and 
(2) distribute disclosures regarding associated 
risks to end users. 
SEC. 405. MATERIAL THREAT DETERMINATIONS REVIEWS. 
Section 319F–2(c)(2)(A) of the Public Health Service 
Act (42 U.S.C. Sec 247d-6b(c)(2)(A)) is amended— 
(1) in clause (i), by striking ‘‘and’’ at the end; 
(2) by redesignating clause (ii) as clause (iii); 
(3) by inserting after clause (i) the following: 
‘‘(ii) establish criteria for the issuance 
of a material threat determination;’’; 
(4) in clause (iii), as so redesignated, by striking 
the period at the end and inserting ‘‘; and’’; and 
(5) by adding at the end the following: 
‘‘(iv) review and reassess determina-
tions under clause (iii) to determine wheth-
er agents continue to present a material 
threat against the United States population 
sufficient to affect national security and 
homeland security.’’. 
SEC. 406. BACKGROUND CHECKS. 
Section 351A(e)(3)(A) of the Public Health Service Act 
(42 U.S.C. 262a(e)(3)(A)) is amended by adding at the end 
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the following: ‘‘In identifying whether an individual is 
within a category specified in subparagraph (B)(ii)(II), the 
Attorney General shall consult with the Secretary of Home-
land Security, the Secretary of Defense, and the Secretary 
of State to determine whether these officials possess any in-
formation relevant to the identification of such an indi-
vidual by the Attorney General.’’. 
SEC. 407. STATE, LOCAL, AND TRIBAL DEFINED. 
In this title, the term ‘‘State, local, and tribal’’ has 
the same meaning that term has in the Homeland Security 
Act of 2002 (6 U.S.C. 101 et seq.). 
TITLE V—FOREIGN RELATIONS 
MATTERS 
SEC. 501. INTERNATIONAL ENGAGEMENT TO ENHANCE BIO-
DEFENSE AND LABORATORY BIOSECURITY. 
The Secretary of State, in consultation with the Spe-
cial Assistant to the President for Biodefense, and the heads 
of appropriate Federal agencies, shall, as appropriate— 
(1) support efforts of other countries to establish 
and build capacity to effectively implement legislation 
criminalizing the development or use of biological 
weapons or acts of bioterrorism; 
(2) engage other countries and international 
nongovernmental entities to develop and establish 
common standards, guidance, and best practices for 
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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; 
(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. 502. INTERNATIONAL COLLABORATION AND INFORMA-
TION SHARING RELATING TO BIOSECURITY. 
The Secretary of State, in consultation 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, as appro-
priate— 
(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-
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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 
(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. 503. INTERAGENCY TASK FORCE ON BEST PRACTICES 
FOR GLOBAL BIOPREPAREDNESS. 
(a) SENSE OF CONGRESS.—It is the sense of Congress 
that preparedness for a chemical, biological, radiological, 
or nuclear incident must be undertaken not only domesti-
cally but also internationally. Specifically, there is a need 
for a global preparedness architecture for such an event. 
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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— 
(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; 
(C) protection; 
(D) regional stockpiling of medical counter-
measures, including considerations of— 
(i) security of the stockpile; 
(ii) 
preservation 
of 
the 
stockpile 
through effective detection and diagnosis, 
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shelf life extension programs, and other 
means; 
(iii) delivery planning; and 
(iv) legal considerations for imple-
menting such an architecture; 
(E) response and attribution; 
(F) other elements that should be a compo-
nent of such an architecture; and 
(G) 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; 
(4) activities undertaken through the National 
Intelligence 
Strategy 
for 
Countering 
Biological 
Threats developed under section 202 and the Inter-
national 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; 
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(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 Director of National Intelligence; 
(8) other Federal departments and agencies, as 
determined appropriate by the Secretary; and 
(9) national biosecurity and biodefense stake-
holder community, including from the pharmaceutical 
and biotechnology industries, and the diagnostic lab-
oratory community, as determined by the Secretary. 
(d) REPORT.—Not later than 1 year after the date of 
the enactment of this Act, the Secretary shall submit to the 
appropriate congressional committees a report on the find-
ings of the task force established under this section. 
SEC. 504. BIOLOGICAL AND TOXIN WEAPONS CONVENTION. 
The Secretary of State shall— 
(1) promote confidence in effective 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-
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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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Union Calendar No. 510 
112TH CONGRESS 
2D SESSION 
H. R. 2356 
[Report No. 112–665, Part I] 
A BILL 
To enhance homeland security by improving efforts 
to prevent, protect against, respond to, and re-
cover from an attack with a weapon of mass de-
struction, and for other purposes. 
NOVEMBER 30, 2012 
The Committees on Energy and Commerce, Transpor-
tation and Infrastructure, Foreign Affairs, the Perma-
nent Select Committee on Intelligence and Science, 
Space, and Technology discharged; committed to the 
Committee of the Whole House on the State of the 
Union and ordered to be printed 
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