< Back to H.R. 5498 (111th Congress, 2009–2010)

Text of the WMD Prevention and Preparedness Act of 2010

This bill was introduced on June 23, 2010, in a previous session of Congress, but was not enacted. The text of the bill below is as of Dec 22, 2010 (Reported by House Committee).

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Union Calendar No. 411

111th CONGRESS

2d Session

H. R. 5498

[Report No. 111–659, Part I]

IN THE HOUSE OF REPRESENTATIVES

June 10, 2010

(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

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.


1.

Short title; table of contents

(a)

Short title

This Act may be cited as the WMD Prevention and Preparedness Act of 2010.

(b)

Table of contents

The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Definitions.

Title I—Intelligence Matters

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

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

Title II—Homeland Security Matters

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

Sec. 202. Definitions.

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

Sec. 204. Dissemination of information analyzed by the Department to State, local, tribal, and private entities with responsibilities relating to homeland security.

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

Sec. 206. 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.

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.

2.

Definitions

In this Act:

(1)

The term appropriate congressional committees means the Committee on Homeland Security of the House of Representatives and any committee of the House of Representatives or the Senate having legislative jurisdiction under the rules of the House of Representatives or Senate, respectively, over the matter concerned.

(2)

The term weapon of mass destruction has the meaning given that term in section 1403(1) fo the Defense Against Weapons of Mass Destruction Act of 1996 (50 U.S.C. 2302).

(3)

The term Intelligence Community has the meaning given that term in section 3(4) of the National Security Act of 1947 (50 U.S.C. 401a(4)).

(4)

The term national biosecurity and biodefense stakeholders means officials from the Federal, State, local, and tribal authorities and individuals from the private sector who are involved in efforts to prevent, deter, prepare for, detect, attribute, respond, and recover from a biological attack or other phenomena that may have serious health consequences for the United States, including wide-scale fatalities or infectious disease outbreaks.

I

Intelligence Matters

101.

National intelligence strategy for countering the threat from weapons of mass destruction

(a)

Strategy

(1)

Development

The Director of National Intelligence, in consultation with the Secretary of Homeland Security and the heads of other appropriate Federal departments and agencies, shall develop and implement—

(A)

a strategy designed to improve the capabilities of the United States to collect, analyze, and disseminate intelligence related to weapons of mass destruction; and

(B)

a plan to implement such strategy.

(2)

Title

The strategy required under paragraph (1) shall be known as the National Intelligence Strategy for Countering the Threat from Weapons of Mass Destruction.

(b)

Contents

The strategy required under subsection (a) shall—

(1)

include methods for the recruitment, training, and retention of a workforce with expertise in the collection, analysis, and dissemination of intelligence related to all types of weapons of mass destruction and science and technology related to weapons of mass destruction, as well as expertise in science and technology relating to threats posed by weapons of mass destruction;

(2)

include methods for collaboration, as appropriate, with individuals with the expertise described in paragraph (1) who are not employed by the Federal Government;

(3)

identify and address domestic needs for analysis and collection including the development of innovative human and technical intelligence collection capabilities and techniques; and

(4)

address each type of weapon of mass destruction as necessary and appropriate.

(c)

Implementation plan

The plan for implementing the strategy required under subsection (a) shall include—

(1)

actions necessary to increase the effectiveness and efficiency of the sharing of intelligence on weapons of mass destruction throughout the Intelligence Community, including a description of statutory, regulatory, policy, technical, security, or other barriers that prevent such sharing, and, as appropriate, the development of uniform standards across the Intelligence Community for such sharing;

(2)

methods to disseminate intelligence products to national biosecurity and biodefense stakeholders in unclassified formats to increase the effectiveness and efficiency of the sharing of information;

(3)

actions necessary to provide open-source intelligence relating to weapons of mass destruction to—

(A)

appropriate Federal departments and agencies;

(B)

State, local, and tribal authorities; and

(C)

private entities;

(4)

specific objectives to be accomplished, with corresponding schedule, for each year of the five-year period that begins on the date on which the strategy is submitted to the appropriate congressional committees under subsection (e) and tasks to accomplish such objectives, including—

(A)

a list prioritizing such objectives and such tasks; and

(B)

a schedule for meeting such objectives and carrying out such tasks;

(5)

assignments of roles and responsibilities to elements of the Intelligence Community to implement the strategy; and

(6)

a schedule for assessment of the effectiveness and efficiency of the strategy, including metrics.

(d)

Coordination

The Director of National Intelligence shall, as the Director considers appropriate, coordinate with State, local, and tribal government authorities, private sector, and nongovernmental organizations in the development of the National Intelligence Strategy for Countering the Threat from Weapons of Mass Destruction.

(e)

Report

Not later than one year after the date of the enactment of this Act, the Director of National Intelligence, in consultation with the Secretary of Homeland Security, shall submit to the appropriate congressional committees the strategy and plan required under subsection (a). The report shall be in unclassified form but with a classified annex, as appropriate.

102.

National intelligence strategy for countering biological threats

(a)

Strategy

(1)

Development

The Director of National Intelligence, in consultation with the Secretary of Homeland Security and the heads of other appropriate Federal departments and agencies, shall develop and implement a strategy and a plan for implementing the strategy that is integrated into the National Intelligence Strategy for Countering the Threat from Weapons of Mass Destruction, as required under this title.

(2)

Title

The strategy required under paragraph (1) shall be known as the National Intelligence Strategy for Countering Biological Threats.

(b)

Contents

The strategy required under subsection (a) shall—

(1)

include a for plan for establishing in the Intelligence Community a cadre of—

(A)

collectors and analysts in all agencies in the Intelligence Community that are familiar with biological threats, biological science, and biotechnology;

(B)

biological scientists;

(C)

biotechologists; and

(D)

experts with knowledge of the current state of technologies that could be used to develop a weapon of mass destruction;

(2)

include a plan for defining the functions, capabilities, and gaps with respect to addressing the risk of a weapon of mass destruction attack in the intelligence workforce;

(3)

identify strategies to recruit, retain, and protect such workforce from workplace exposures to biological agents in the conduct of the duties of such workforce;

(4)

include methods for collaboration, as appropriate, with individuals with expertise described in paragraph (1) who are not employed by the Federal Government;

(5)

address domestic and international needs for analysis and collection;

(6)

include a plan for defining, integrating, focusing, and enhancing existing capabilities in the Intelligence Community dedicated to current tactical and strategic biological threats; and

(7)

include a plan for ensuring the prioritization and sustained commitment of intelligence personnel and resources to address biological threats.

(c)

Implementation plan

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

(1)

include actions necessary to increase the effectiveness and efficiency of the sharing of intelligence throughout the Intelligence Community on biological weapons and organisms that could be used for biological terrorism, including a description of statutory, regulatory, policy, technical, security, or other barriers that prevent such sharing, and, as appropriate, the development of uniform standards across the Intelligence Community for such sharing;

(2)

address strategic and tactical human intelligence, measurement and signature intelligence, technical intelligence, medical intelligence, and open-source intelligence activities necessary to implement the strategy;

(3)

identify specific objectives to be accomplished during each year of the five-year period that begins on the date on which the strategy is submitted to the appropriate congressional committees under subsection (d) and tasks to accomplish such objectives, including—

(A)

a list prioritizing such objectives and such tasks; and

(B)

a schedule for meeting such objectives and carrying out such tasks;

(4)

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

(5)

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

(6)

a schedule for evaluating on a regular basis the efforts of the Intelligence Community and progress on understanding and countering biological threats.

(d)

Report

Not later than one year after the date of the enactment of this Act, the Director of National Intelligence, in consultation with the Secretary of Homeland Security, shall submit to the appropriate congressional committees the strategy and plan required under subsection (a). The report shall be in unclassified form but with a classified annex, as appropriate.

II

Homeland Security Matters

201.

Weapons of mass destruction prevention and preparedness

(a)

In general

The Homeland Security Act of 2002 (6 U.S.C. 101 et seq.) is amended by adding at the end the following new title:

XXI

WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS

A

Prevention and Deterrence

2101.

Weapons of Mass Destruction Intelligence and Information Sharing Unit

(a)

In general

There is established in the Office of Intelligence and Analysis of the Department a unit for weapons of mass destruction intelligence and information sharing. The unit shall conduct intelligence and information sharing activities consistent with the National Intelligence Strategy for Countering the Threat from Weapons of Mass Destruction under section 101 of the WMD Prevention and Preparedness Act of 2010 and the National Intelligence Strategy for Countering Biological Threats under section 102 of that Act and shall—

(1)

evaluate and establish a baseline of terrorist actors, their claims, and their plans to conduct attacks involving chemical, biological, radiological, and nuclear materials against the Nation;

(2)

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

(3)

provide tailored analytical support on these threats to State, local, and tribal authorities as well as members of the public health, scientific, and response communities; and

(4)

perform other responsibilities, as assigned by the Secretary.

(b)

Coordination

Where appropriate, the unit shall coordinate with others in the Intelligence Community, including the National Counter Proliferation Center.

(c)

Report

Not later than one year after the date of the enactment of this section and annually thereafter, the Secretary shall report to the appropriate congressional committees on the intelligence and information sharing activities of the unit for weapons of mass destruction intelligence and information sharing established under subsection (a) and all relevant entities within the Department to counter the threat from weapons of mass destruction and how the Department acted in accordance with relevant intelligence strategies, including the National Intelligence Strategy for Countering the Threat from Weapons of Mass Destruction and the National Intelligence Strategy for Countering Biological Threats.

2102.

Information sharing and collaboration for biosecurity and biodefense

(a)

Responsibilities of Secretary of Homeland Security

To increase situational awareness, the Secretary, acting through the Under Secretary for Intelligence and Analysis, shall—

(1)

to the greatest extent practicable, integrate into the homeland security, intelligence, and information sharing process national biosecurity and biodefense stakeholders;

(2)

develop an information sharing framework for homeland security intelligence and information sharing withe national biosecurity and biodefense stakeholders;

(3)

enable national biosecurity and biodefense stakeholders to provide recommendations with respect to the development of mechanisms and protocols to integrate information from national biosecurity and biodefense stakeholders;

(4)

leverage existing and emerging homeland security capabilities and structures, including fusion centers established pursuant to section 210A, to enhance prevention, detection, preparedness, and collective response, attribution, and recovery efforts of from a biological attack or other phenomena that may have serious health consequences for the United States, including wide-scale fatalities or infectious disease outbreaks; and

(5)

advance partnerships between the Department and other Federal departments and agencies in assessing potential threats and the risks from the intentional use of biological agents by terrorists or other actors.

(b)

Coordination with Other Departments and Agencies

The Secretary shall work in coordination with the Secretary of State, the Secretary of Agriculture, the Secretary of Health and Human Services, and the heads of other appropriate Federal agencies.

2103.

Bioterrorism risk assessments

(a)

Risk assessment

The Secretary, in coordination with the heads of other appropriate Federal departments and agencies, shall produce biennial integrated risk assessments, to be known as Bioterrorism Risk Assessments to identify and assess the evolving terrorist risk of a biological attack or other phenomena that may have serious health consequences for the United States, including wide-scale fatalities or infectious disease outbreaks. These assessments shall—

(1)

identify the threat, vulnerability, and consequences of a biological terrorist attack against the United States;

(2)

take into account intelligence and information regarding terrorist intentions, capabilities, plans, and actions;

(3)

be used to inform and guide threat assessments and determinations made by the Secretary regarding agents and toxins pursuant to section 302(9), and to guide prioritization of other homeland security activities, as appropriate;

(4)

provide the basis for risk-informed investments in national strategic biodefense research, development, planning, preparedness, and collective response to biological attacks;

(5)

identify key knowledge and data gaps;

(6)

define critical biodefense vulnerabilities;

(7)

provide risk-based prioritization of agents for bioterrorism; and

(8)

evaluate progress in implementing national biopreparedness policy.

(b)

Requirement

The Secretary shall—

(1)

convene an interagency task force of subject matter experts to provide recommendations to the Under Secretary for Science and Technology as to the adequacy of the methodology used in the Assessments and to establish requirements and standards for the Assessments;

(2)

engage with national biosecurity and biodefense stakeholders to obtain their input regarding the Assessments, as appropriate; and

(3)

ensure, to the greatest extent practicable, that the Assessments inform the risk management decisions of the Department and can be made available to national biosecurity and biodefense stakeholders, as appropriate.

2104.

Radiological materials security

(a)

Risk Assessment

The Secretary shall enhance domestic preparedness for and collective response to terrorism by conducting annual risk assessments regarding the threat, vulnerability, and consequences of theft or other procurement of radiological materials that could be used by a terrorist in a radiological dispersion device, including any specific threat information pertinent to the use of radiological materials in a possible terrorist attack using a radiological dispersion device.

(b)

Considerations

In conducting the terrorism risk assessments under subsection (a), the Secretary shall—

(1)

consult with Secretary of Energy, Secretary of Heath and Human Services, and the Nuclear Regulatory Commission;

(2)

consider relevant studies previously prepared by other Federal agencies, or other reputable sources;

(3)

focus on those radiological materials that constitute the greatest risk, and designate those materials as high-risk radiological materials for purposes of this section;

(4)

consider the potential radiological dispersion device value of different radiological materials including availability, dispersability, and ease of handling of such materials;

(5)

consider the vulnerability for theft or other procurement that different facilities represent; and

(6)

consider the consequences of a successful radiological dispersion device attack, including risk of death or injury and economic losses.

(c)

Consultation

In conducting the terrorism risk assessments under subsection (a), the Secretary shall consult with the Intelligence Community, the Secretary of Energy and the Field Intelligence Elements of the National Laboratories, and the Nuclear Regulatory Commission, the Secretary of Health and Human Services, and other appropriate experts to integrate and analyze information needed to develop the risk assessment.

(d)

Dissemination of findings

The Secretary shall disseminate the findings of the risk assessments and any specific risk information developed in the assessment to all participating agencies including those described in subsection (c), as well State and local agencies, and the facilities containing radiological source material and regulated by the Nuclear Regulatory Commission.

(e)

Classification

The Secretary shall, as appropriate, share the terrorism risk assessments with law enforcement and critical infrastructure operators with appropriate security clearances. The Secretary shall also make available an unclassified version to each agency with which the Secretary is required to consult under subsection (c), as well as State and local law enforcement and public health authorities, and facilities possessing radiological materials with the support of the Department of Energy.

2105.

Enhanced biosecurity measures

(a)

Regulations

At the request of the Secretary, the Secretary, in consultation with the Secretary of Agriculture, the Secretary of Health and Human Services, and the heads of other appropriate Federal agencies, shall, through a negotiated rulemaking committee under subchapter III of chapter 5 of title 5, United States Code, establish enhanced biosecurity measures for persons or laboratories that possess, use, or transfer Tier I Material Threat Agents. Such measures shall include—

(1)

standards for personnel surety programs;

(2)

standards for biosecurity practices and training of responsible officials, laboratory personnel, and support personnel;

(3)

standards for performing laboratory vulnerability assessments in collaboration with each facility;

(4)

risk-based laboratory security performance standards;

(5)

penalties (including civil money penalties and intermediate sanctions), in addition to any other penalties that may apply under provisions of law; and

(6)

any other security standards determined necessary by the Secretary, the Secretary of Agriculture, Secretary of Health and Human Services, and other agencies as appropriate.

(b)

Negotiated rulemaking committee

The Secretary shall establish a negotiated rulemaking committee for purposes of subsection (a). Such committee shall include a representative from each of the following:

(1)

The Department.

(2)

The Department of Health and Human Services.

(3)

The Department of Agriculture.

(4)

The Department of Defense.

(5)

The Department of Energy.

(6)

The Department of Justice.

(7)

For-profit research institutions.

(8)

Academic research institutions.

(9)

Nonprofit research institutions

(10)

Other stakeholders, as the Secretary determines appropriate.

(c)

Time requirement

The procedures for the negotiated rulemaking referred to in subsection (a) shall be conducted in a timely manner to ensure that—

(1)

any recommendations with respect to proposed regulations are provided to the Secretary and the heads of the other appropriate Federal agencies not later than one year after the date of the enactment of this section; and

(2)

a final rule is promulgated not later than two years after the date of the enactment of this section.

(d)

Factors to be considered

In developing proposed and final standards pursuant to the negotiated rulemaking referred to in subsection (a), the negotiated rulemaking committee shall consider—

(1)

the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism (established under section 1851 of the Implementing Recommendations of the 9/11 Commission Act of 2007 (Public Law 110–53; 121 Stat. 501));

(2)

the National Science Advisory Board for Biosecurity (established under section 217a of title 42, United States Code, section 222 of the Public Health Service Act, and section 205 of the Pandemic and All-Hazards Preparedness Act);

(3)

any working group established under Executive Order 13486 (74 Fed. Reg. 2289) relating to strengthening laboratory biosecurity;

(4)

the Chemical Facility Anti-Terrorism Act of 2009; and

(5)

views from representatives of biosecurity and biodefense stakeholders for methods to minimize any disincentives to biological research arising from enhanced biosecurity measures.

(e)

Implementation of enhanced biosecurity measures

(1)

Enforcement

The Secretary of Agriculture and the Secretary of Health and Human Services, in consultation with the Secretary, as appropriate, shall enforce the measures established under subsection (a) and any standards promulgated pursuant to such section.

(2)

Training programs

The Secretary of Agriculture and the Secretary of Health and Human Services, in coordination with the Secretary and the heads of other Federal agencies, as appropriate, shall develop training programs that comply with such measures and standards.

(3)

Procedures

The Secretary of Agriculture and the Secretary of Health and Human Services, in consultation with the Secretary and the heads of other Federal agencies, as appropriate, shall develop and implement procedures with respect to when and how penalties and intermediate sanctions may be imposed. Such procedures shall provide for notice, a reasonable opportunity to respond to the proposed penalty or intermediate sanction, and appropriate procedures for appealing determinations relating to the imposition of a penalty or intermediate sanction.

(4)

Simultaneous laboratory inspections

(A)

Inspection data sharing and enforcement uniformity

The Secretary of Agriculture and the Secretary of Health and Human Services shall periodically provide the Secretary with all data concerning inspections of laboratories that handle Tier 1 Material Threat Agents to ensure uniformity in enforcement of the regulations enacted under subsection (a) and to identify areas where the Secretary can provide guidance to the Secretary of Agriculture or the Secretary of Health and Human Services about approaches to enhance security at specific laboratories.

(B)

Simultaneous inspections

Any inspections of the same laboratory conducted by the Secretary of Agriculture pursuant to section 212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002 and the Secretary of Health and Human Services for compliance with regulations promulgated under the Select Agent Program under section 351A(a)(1) of the Public Health Service Act, shall be conducted simultaneously to the extent practicable.

(C)

Common inspection procedures

Departments conducting simultaneous inspections of a laboratory under this subsection shall ensure, to the maximum extent practicable, that such inspections are conducted using a common set of inspection procedures across such departments in order to minimize the administrative burden on such laboratory.

(D)

Inspection reports

Inspection reports generated under this paragraph shall be made available to each Federal agency that supports select agent laboratory activities at the institution that is the subject of the inspection report, and to the institutions that are the object of inspections.

2106.

Tier I Material Threat Agent locations

The Secretary of Agriculture and the Secretary of Health and Human Services shall provide to the Secretary a list of laboratories and other locations where Tier I Material Threat Agents are present in the United States and its territories.

2107.

High containment biological laboratory security grants

(a)

Grants authorized

The Secretary, acting through the Administrator of the Federal Emergency Management Agency, may award grants based on risk to academic and nonprofit organizations and to State, local, and tribal authorities that possess, use, or transfer Tier I Material Threat Agents, to enhance security at laboratories of such organizations and authorities.

(b)

Authorization of appropriations

There is authorized to be appropriated to the Department of Homeland Security to carry out this subsection $50,000,000 for each of fiscal years 2011 through 2013.

2108.

Laboratory biosecurity information sharing

(a)

In general

Consistent with the responsibilities of the Secretary under section 201(d), the Secretary shall establish procedures, with appropriate controls on access, for the sharing of homeland security information, including vulnerability assessments, security plans, best practices and other laboratory biosecurity-related information, as the Secretary determines appropriate, with State, local, and tribal government authorities, including law enforcement authorities and emergency response providers.

(b)

Access to information in databases

In carrying out this section, the Secretary shall have access to and may use information from the national databases established under section 212(d)(2) of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401(d)(2)) and subsections (d)(2) and (f)(3) of section 351A of the Public Health Service Act (42 U.S.C. 262a).

(c)

Classified and sensitive information

The Secretary shall ensure that any information disseminated under this section is handled consistent with—

(1)

the authority of the Director of National Intelligence to protect intelligence sources and methods under the National Security Act of 1947 (50 U.S.C. 401 et seq.) and related procedures or similar authorities of the Attorney General concerning sensitive law enforcement information;

(2)

section 552a of title 5, United States Code (commonly referred to as the Privacy Act of 1974); and

(3)

other relevant laws.

2109.

Periodic homeland security review of criminal statutes

(a)

In general

The Secretary, in coordination with the Attorney General and the heads of other Federal departments and agencies, as appropriate, shall, for purposes of enhancing homeland security—

(1)

periodically review and recommend updates to criminal laws to ensure that such laws are well suited to the evolving risks of misuse of life sciences by terrorists and others; and

(2)

ensure that national biosecurity and biodefense stakeholders at unique risk of exploitation have access to guidance regarding actions that can reduce the risk of misuse of life sciences by terrorists and others.

(b)

Report

Not later than one year after the date of the enactment of this section, and biannually thereafter, the Secretary, in coordination with the Attorney General, shall submit to the appropriate congressional committees the recommended updates to criminal laws, as described in subsection (a)(1).

2110.

Export enforcement for counter-proliferation

(a)

In general

The Secretary, in coordination with the Secretary of Commerce, the Secretary of Defense, the Attorney General, the Secretary of State, the Director of National Intelligence, and the heads of other appropriate Federal agencies shall—

(1)

conduct homeland security investigations and enforce criminal violations of customs and export laws of the United States related to military items, controlled commodities, and sanctioned or embargoed countries to prevent individuals, terrorist groups, foreign adversaries, and hostile nations from—

(A)

illegally obtaining sensitive United States technology and munitions; and

(B)

obtaining weapons of mass destruction components, precursors, and delivery systems, including—

(i)

United States military technical data, hardware, small arms and defense services;

(ii)

dual-use technical data/source code and commodities; and

(iii)

deemed exports; and

(2)

conduct industry outreach with manufacturers and exporters of strategic commodities that may be targeted for procurement by terrorist organizations and the countries that support them as well as countries identified as weapons proliferators, in a manner that acknowledges commerce and trade, by—

(A)

educating companies and individuals on the export laws of the United States;

(B)

discussing export licensing issues and requirements;

(C)

identifying red flag indicators used in illegal procurement;

(D)

identifying the government agencies responsible for the licensing of export-controlled commodities and technology; and

(E)

establishing and fostering relationships whereby companies and individuals can report suspicious contacts or attempts to violate the export laws of the United States.

(b)

National Export Enforcement Coordination

(1)

Establishment; membership

There is established in the Department a unit responsible for national export enforcement coordination that is managed by the Secretary. The unit shall be composed of members who are representatives from the Department, the Department of Commerce, the Department of Defense, the Department of Energy, the Department of Justice, the Department of State, the Intelligence Community, and other Federal agencies as appropriate.

(2)

Responsibilities

The unit shall carry out the following responsibilities:

(A)

Coordinating law enforcement counter-proliferation investigations and intelligence counter-proliferation activities.

(B)

Addressing licensing inquiries, reviews, requests, checks, and verifications.

(C)

Conducting outreach and providing training to the export trade community.

B

Preparedness

2121.

Communication of threat information and alerts

(a)

Findings

Congress makes the following findings:

(1)

The Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism recommended that the Federal Government should practice greater openness of public information so that citizens better understand the threat and the risk this threat poses to them.

(2)

There are unique challenges for community preparedness for attacks from weapons of mass destruction and their agents.

(b)

Terrorism threat awareness

(1)

Terrorism threat awareness

The Secretary, in coordination with the heads of appropriate Federal agencies, shall ensure that homeland security information concerning terrorist threats is provided to State, local, and tribal authorities and the public within the United States, as appropriate, for purposes of preparedness and collective response to terrorism and for other purposes.

(2)

Threat bulletins

(A)

In general

Consistent with the requirements of paragraph (1), the Secretary shall, on a timely basis, prepare unclassified terrorism-related threat and risk assessments.

(B)

Requirements

Each assessment required under subparagraph (A) shall—

(i)

include guidance to the public for preventing and responding to acts of terrorism; and

(ii)

be made available on the Internet website of the Department and other publicly accessible Internet websites, communication systems, and information networks.

(3)

Guidance to State, local, and tribal authorities

The Secretary—

(A)

acting through the Administrator of the Federal Emergency Management Agency, shall provide to State, local, and tribal authorities written guidance on communicating terrorism-related threats and risks to the public within their jurisdictions; and

(B)

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

(4)

Use of existing resources

The Secretary shall use Internet websites, communication systems, and information networks in operation on the date of an assessment under this subsection to satisfy the requirements of paragraph (2)(B)(ii). The Secretary shall provide guidance on how State, local, tribal, and private entities can partner with public television stations to disseminate information provided by the Department and shall provide information on best practices on disseminating information to residents of local communities, including leveraging public television stations.

2122.

Individual and community preparedness for weapons of mass destruction

(a)

In general

The Secretary, acting through the Administrator for the Federal Emergency Management Agency, shall assist State, local, and tribal authorities in improving and promoting individual and community preparedness and collective response to weapons of mass destruction and terrorist attacks involving chemical, biological, radiological, and nuclear materials against the United States by—

(1)

developing guidance and checklists of recommended actions for individual and community prevention and preparedness efforts and disseminating such guidance and checklists to communities and individuals;

(2)

disseminating the guidance developed under section 2151 to communities and individuals, as appropriate;

(3)

providing information and training materials in support of individual and community preparedness efforts;

(4)

conducting individual and community preparedness outreach efforts; and

(5)

such other actions as the Secretary determines appropriate.

(b)

Coordination

Where appropriate, the Secretary shall coordinate with private sector and nongovernmental organizations to promote individual and community preparedness and collective response to weapons of mass destruction and terrorist attacks involving chemical, biological, radiological, and nuclear materials against the United States.

(c)

Best practices

In compiling guidance for individual and community preparedness in order to carry out subsection (a)(3), the Secretary shall give due regard to best practices based on the experience of other countries and agencies and th expertise of academic institutions and non-governmental organizations.

C

Detection

2131.

National biosurveillance strategy

(a)

Current State of biosurveillance

The Secretary shall examine of the state of domestic and global biosurveillance.

(b)

Strategy for biosurveillance

The Secretary shall submit to the appropriate congressional committees a national strategy for biosurveillance.

(c)

Matters for inclusion

(1)

In general

In developing the strategy required under subsection (b), the Secretary shall take into consideration—

(A)

the state of biosurveillance domestically and internationally;

(B)

material threat assessments and determinations developed by the Secretary in accordance with the Project BioShield Act of 2004 (Public Law 108–276) and the amendments made by that Act;

(C)

reports on global trends produced by the Office of the Director of National Intelligence regarding the biological threat;

(D)

information available in biosurveillance systems and changes to information technology to allow for the incorporation and integration of this information;

(E)

Intelligence Community needs as articulated in relevant intelligence strategies; and

(F)

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

(2)

Additional requirements

This strategy required under subsection (b) shall—

(A)

include a plan for advancing situational awareness;

(B)

identify key elements of information to be shared, critical sensitivities to be protected, and a framework for enabling information exchange;

(C)

include a plan for fostering information sharing between law enforcement, security, intelligence, and national biosecurity and biodefense stakeholders to identify potential threats, reduce vulnerabilities and improve collective response activities to and investigations of suspected biological attacks; and

(D)

include strategic and implementation plans for the National Biosurveillance Integration Center under section 316.

2132.

Detection of biological attacks

(a)

Program

The Secretary shall carry out a program in the Department to detect a biological attack or event. Through such program, the Secretary shall—

(1)

deploy detectors to areas, based on risk, to indicate the presence of biological agents;

(2)

provide information to participating laboratories for their use in monitoring public health, and biological material from these detectors to participating laboratories for testing;

(3)

provide information about the presence of biological agents to public health and law enforcement personnel at all levels of government; and

(4)

provide advanced planning tools, concepts of operations (including alarm resolution protocols), and training exercises for collective response to and recovery from biological attacks.

(b)

Program requirements

Under the program required under subsection (a), the Secretary shall—

(1)

enter into memoranda of agreement or interagency agreements under the Economy Act of 1933 (31 U.S.C. 1535 et seq.) with the Director of the Centers of Disease Control and Prevention and the Administrator of the Environmental Protection Agency, and the heads of other Federal departments and agencies, setting forth roles and responsibilities, including with respect to filter testing protocols for participating laboratories and coordination with appropriate State, local, and tribal agencies;

(2)

determine, on an annual basis, whether plans for biological detector capabilities and coverage sufficiently protect the United States population; and

(3)

acting through the Under Secretary for Science and Technology, and in consultation with the Director for the Centers for Disease Control and Prevention, implement an assay equivalency program for biological threat assays that—

(A)

may evaluate biological threat detection assays, their protocols for use, and their associated response algorithms for confirmation of biological threat agents, taking performance measures and concepts of operation into consideration;

(B)

may develop assay equivalency standards based on the findings of the evaluation under subparagraph (A);

(C)

will be updated as necessary;

(D)

shall require implementation of the standards developed under subparagraph (B) for all Department biological detection programs; and

(E)

shall make such standards available to support all other Federal biological detection programs.

(c)

Contract authority

The Secretary is authorized to enter into contracts with participating laboratories for—

(1)

the provision of laboratory services to test detector filters on a fee-for-service basis or on a prepayment or other similar basis; and

(2)

administrative and other costs related to hosting program personnel and equipment in these laboratories.

(d)

Definitions

In this section:

(1)

The term participating laboratory means a laboratory that has been accepted as a member of the Laboratory Response Network for Bioterrorism that—

(A)

is fully equipped to detect and respond quickly to acts of biological terrorism;

(B)

provides biocontainment and microbiological analysis in support of the Department, the Federal Bureau of Investigation and other law enforcement agencies with responsibilities for investigating biological incidents; and

(C)

supports threat agent characterization studies and assay evaluation, research and development.

(2)

The term assay means any scientific test that is designed to detect the presence of a biological threat agent that is of a type selected under criteria established by the Secretary.

2133.

Rapid biological threat detection and identification

(a)

In general

Notwithstanding section 302(4) the Secretary shall require the Under Secretary for Science and Technology, in consultation with the heads of other relevant operational components of the Department, assess whether the development of screening capabilities for biological agents, pandemic influenza, and other infectious diseases should be undertaken by the Science and Technology Directorate to support entry and exit screening at ports of entry and for other purposes.

(b)

Development of methods

If the Under Secretary determines that the development of such screening capabilities should be undertaken, the Secretary shall, to the extent possible, initiate development of safe and effective methods to rapidly screen incoming travelers at ports of entry for biological agents, pandemic influenza, and other infectious diseases.

(c)

Collaboration

In developing methods under subsection (b), the Secretary may collaborate with the heads of other Federal agencies, as needed.

2134.

Establishment of the system assessment and validation for emergency responders (SAVER) program

The Secretary, acting through the Under Secretary for Science and Technology, shall carry out a program for system assessment and validation of emergency response equipment at the Department, to be known as the SAVER Program. The Secretary shall ensure that such program—

(1)

conducts objective, impartial, practitioner-relevant, and operationally-oriented assessments and validations of commercial emergency responder equipment and systems, including hand-held detectors for agents used in weapons of mass destruction;

(2)

is supported by a network of scientists who perform the assessment and validation activities;

(3)

provides results along with other relevant equipment information to the emergency response provider community in an operationally useful form;

(4)

provides information on equipment that falls within the categories listed in the Department’s authorized equipment list;

(5)

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

(6)

shares such information nationally with the emergency response provider community.

2135.

Payment for bioterrorism laboratory services

In carrying out their functions, responsibilities, authorities, and duties to counter biological terrorism, the Secretary, the Attorney General, and the heads of other participating Federal agencies are authorized to enter into contracts with the State and local public health laboratories that compose the Laboratory Response Network for Bioterrorism, and any other qualified laboratories, for the provision of laboratory testing services on a fee-for-service basis or on a prepayment or other similar basis.

2136.

Establishment of the integrated consortium of laboratory networks

(a)

Establishment

There is established in the Department an Integrated Consortium of Laboratory Networks that is managed by the Secretary.

(b)

Requirements

The Integrated Consortium of Laboratory Networks shall—

(1)

be composed of networks of laboratories capable of integrated and coordinated response to and consequence management of attacks from weapons of mass destruction, acts of terrorism, and other incidents requiring laboratory response capabilities;

(2)

be a coordinated and operational system of laboratory networks that provide timely, high quality results for early detection and effective consequence management of attacks from weapons of mass destruction, acts of terrorism, and other events requiring an integrated laboratory response;

(3)

serve as a system of laboratory networks that are equipped to detect and respond quickly to attacks from weapons of mass destruction and acts of terrorism;

(4)

provide limited containment and analysis in support of the Department, the Federal Bureau of Investigation, and other law enforcement agencies with responsibilities for investigating incidents involving weapons of mass destruction or their agents; and

(5)

support threat agent characterization studies and assay evaluation, research and development.

D

Attribution

2141.

Bioforensics capabilities and strategy

(a)

National bioforensics analysis center

There is established in the Department a National Bioforensics Analysis Center which shall serve as the lead Federal facility to—

(1)

provide definitive forensic examination of biothreat agents and related evidence;

(2)

provide necessary biocontainment;

(3)

integrate bioforensics requirements for law enforcement, national security, and homeland security;

(4)

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

(5)

develop national bioforensics standards;

(6)

maintain the national bioforensics repository collection as a reference collection of biological agents and toxins for bioforensics comparisons and identifications; and

(7)

support threat agent characterization studies and bioforensics assay evaluation research and development.

(b)

National Bioforensics repository collection

(1)

In general

The National Bioforensics Analysis Center shall maintain a distributed national bioforensics repository collection.

(2)

Activities

The national bioforensics repository collection shall—

(A)

receive, store, and distribute biological threat agents and toxins;

(B)

serve as a distributed reference collection for comparative bioforensics identifications and characterizations; and

(C)

support threat agent characterization studies and the development of bioforensics assays, genomic analyses, organic and inorganic chemical analyses, electron microscopy analyses, and other relevant assays, analyses, and tests.

(3)

Participation

(A)

In general

The Secretary, the Attorney General, the Secretary of Agriculture, the Secretary of Defense, the Secretary of Energy, the Secretary of Health and Human Services, the Director of National Intelligence, and the head of any other appropriate executive agency with a biological agent or toxin collection that is useful for the bioforensics analysis of biological attacks, performance of biological threat agent identification and characterization studies, or evaluation and development of bioforensics assays and methods shall provide to the distributed national bioforensics repository collection authenticated replicate samples of, or information on, all relevant biological strains and toxins, as determined by the Secretary, in consultation with the head of the executive agency possessing the agent or toxin.

(B)

Other biological agents and toxins

The Secretary shall require the contribution to the national bioforensics repository collection of authenticated replicate samples of, or information on, all relevant biological strains and toxins, as determined by the Secretary, from public and private biological agent and toxin collections that were collected or created with support from a Federal grant or contract and that support the functions described in paragraph (2).

(4)

Access

The Secretary shall—

(A)

provide any executive agency that submits a biological agent or toxin, or information on a biological agent or toxin, to the national bioforensics repository collection with access to the collection; and

(B)

establish a mechanism to provide public and private entities with access to agents or toxins in, or information regarding, the national bioforensics repository collection, as determined appropriate by the Secretary, with appropriate protection of classified or law enforcement sensitive information and intellectual property rights.

(5)

Report

(A)

In general

Not later than one year after the date of the enactment of this section, and annually thereafter, the Secretary, in consultation with the Attorney General, the Secretary of Agriculture, the Secretary of Defense, the Secretary of Energy, the Secretary of Health and Human Services, the Director of National Intelligence, and the head of any other appropriate executive agency that participates in or contributes agents, or toxins, or information to the national bioforensics repository collection, shall submit to the appropriate committees of Congress a report regarding the national bioforensics repository collection.

(B)

Contents

The report submitted under subparagraph (A) shall—

(i)

discuss the status of the establishment of the distributed national bioforensics repository collection;

(ii)

identify domestic and international biological agent and toxin collections that would prove useful in carrying out the functions of the distributed national bioforensics repository collection;

(iii)

examine any access or participation issues affecting the establishment of the distributed national bioforensics repository collection or the ability to support bioforensics analysis, threat agent characterization studies, or bioforensics assay evaluation, research, and development, including—

(I)

intellectual property concerns;

(II)

access to collected or created biological agent or toxin collections funded by a Federal grant or contract;

(III)

costs incurred by domestic and international biological agent and toxin collections to access or contribute biological agents or toxins to the national bioforensics repository collection; and

(IV)

access to the national bioforensics repository collection by public and private researchers to support threat agent characterization studies, bioforensics assay evaluation, research, and development, and biosecurity research and development; and

(iv)

other issues determined appropriate.

(c)

National bioforensics strategy

(1)

In general

The Secretary, in coordination with the Attorney General, the Secretary of Agriculture, the Secretary of Defense, the Secretary of Health and Human Services, the Director of National Intelligence, and the head of any other appropriate executive agency, as determined by the Secretary, shall develop, coordinate, and maintain a national bioforensics strategy.

(2)

Contents

The national bioforensics strategy shall—

(A)

provide for a coordinated approach across all executive agencies with responsibilities for—

(i)

conducting bioforensics examination of biological threat agents and related evidence; and

(ii)

generating bioforensics requirements for law enforcement, national security, and homeland security;

(B)

describe the roles and responsibilities of all relevant executive agencies, including—

(i)

research to characterize threat agents;

(ii)

assay evaluation, research, and development; and

(iii)

funding;

(C)

establish mechanisms, in coordination with State, local, and tribal authorities, for coordinating with public health, homeland security, and law enforcement agencies for the collection or receipt, transfer, or submission of bioforensics evidence for analysis and its use; and

(D)

include—

(i)

guidance for collecting, processing, and analyzing samples;

(ii)

requirements for reporting bioforensics information to appropriate agencies; and

(iii)

requirements for the distributed national bioforensics repository collection.

(3)

Report

Not later than one year after the date of the enactment of this section, and biennially thereafter, the Secretary, in consultation with the Attorney General, the Secretary of Agriculture, the Secretary of Defense, the Secretary of Health and Human Services, the Director of National Intelligence, and the heads of other appropriate agencies, as determined by the Secretary, shall submit to the appropriate committees of Congress the national bioforensics strategy.

(d)

Concept of operations

The Secretary, in coordination with the Attorney General and the heads of any other appropriate Federal agencies shall ensure the availability of a detailed concept of operations for information sharing and all-source analysis to support timely attribution of biological attacks.

(e)

Detailee program

Subject to the availability of appropriations, the Secretary may implement a detailee program to detail from governmental entities national biosecurity and biodefense stakeholders with appropriate clearances, on a reimbursable basis, to the National Bioforensics Analysis Center for the purpose of—

(1)

providing training and other educational benefits for such stakeholders to help them to better understand the policies, procedures, and laws governing national bioforensics activities; and

(2)

bolstering the capabilities and information sharing activities of the National Bioforensics Analysis Center with national biosecurity and biodefense stakeholders.

(f)

Research and development

The Secretary, in coordination with the Attorney General and the heads of any other appropriate Federal agencies, shall establish a national-level research and development strategy and implementation plan to advance the field of bioforensics.

(g)

Definition of bioforensics

In this section, the term bioforensics means the scientific discipline dedicated to analyzing evidence from an attack with a biological weapon of mass destruction, an act of bioterrorism, a biological agent- or toxin-based criminal act, or the inadvertent release of a biological agent or toxin for attribution purposes.

2142.

Federal law enforcement training to investigate biological threats

The Secretary, in coordination with the Attorney General, the Secretary of Agriculture, the Secretary of Health and Human Services, and the heads of other appropriate Federal departments and agencies, shall make available to law enforcement, public health, and security personnel at the Federal Law Enforcement Training Center training on recognizing and responding to situations involving potential biological threats, including performing joint criminal and epidemiological investigations, and shall—

(1)

ensure that tailored tactics, techniques, and procedures are made available to law enforcement and security personnel, including access to the tools needed to respond to biological threats;

(2)

promote the use of simulation among Federal partners to exercise capabilities, refine operational concepts, and strengthen relationships across the Government; and

(3)

make training available that will ensure that law enforcement, public health, and agricultural investigations of biological threats are coordinated.

E

Response

2151.

First responder guidance concerning weapons of mass destruction attacks

(a)

Establishment of voluntary guidance

Not later than one year after the date of the enactment of this section, the Secretary shall—

(1)

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

(2)

in developing the guidance under paragraph (1), review the experiences of other countries and the expertise of academic institutions and non-governmental organizations; and

(3)

make such guidance available to State, local, and tribal authorities, nongovernmental organizations, the private sector, and the public.

(b)

Contents

The guidance developed under subsection (a)(1) shall include—

(1)

protective action guidance for ensuring the security, health, and safety of emergency response providers;

(2)

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

(3)

best practices for emergency response providers to effectively deal with individuals affected by an incident involving chemical, biological, radiological, or nuclear material.

(c)

Review and revision of guidance

The Secretary shall—

(1)

review the guidance developed under subsection (a)(1) at least once every 2 years,

(2)

make revisions to the guidance as appropriate; and

(3)

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

(d)

Procedures for developing and revising guidance

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

(1)

inventory existing relevant hazardous material 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 developed under subsection (a)(1);

(3)

determine which entities should be consulted in developing or revising the guidance;

(4)

prioritize, on a regular basis, guidance that should be developed or revised; and

(5)

develop and disseminate the guidance in accordance with the prioritization under paragraph (4).

(e)

Consultations

The Secretary shall develop and revise the guidance developed under subsection (a)(1), and the procedures required under subsection (d), in consultation with—

(1)

the heads of other Federal departments and agencies, as appropriate;

(2)

the National Advisory Council established under section 508;

(3)

the National Domestic Preparedness Consortium;

(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 appropriate congressional committees—

(1)

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

(2)

any guidance in effect on the date of the report;

(3)

a list of entities to which the guidance described in paragraph (2) was disseminated;

(4)

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

(5)

guidance required under subsection (d)(4), and the methodology used by the Secretary for such prioritization; and

(6)

a plan for developing, revising, and disseminating the guidance.

2152.

Integrated plume modeling for collective response

(a)

Development

(1)

In general

The Secretary shall acquire, use, and disseminate integrated plume models to enable rapid response activities following a chemical, biological, nuclear, or radiological attack or event.

(2)

Scope

The Secretary shall—

(A)

ensure the rapid development and distribution of integrated plume models to appropriate officials of the Federal Government and State, local, and tribal authorities to enable immediate response to a chemical, biological, or radiological attack or event;

(B)

establish mechanisms for dissemination by appropriate emergency response officials of the integrated plume models described in paragraph (1) to nongovernmental organizations and the public to enable appropriate collective response activities;

(C)

ensure that the development and dissemination of integrated plume models are assessed during exercises administered by the Department; and

(D)

ensure that lessons learned from assessing the development and dissemination of integrated plume models during exercises administered by the Department are put into the Department of Homeland Security Lessons Learned Information Sharing system.

(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 development and dissemination of integrated plume models during exercises administered by the Department; and

(3)

recommendations for improving integrated plume models, as appropriate.

(c)

Definitions

For purposes of this section:

(1)

The term plume model means the assessment of the location and prediction of the spread of agents following a chemical, biological, radiological, or nuclear attack or event.

(2)

The term integrated plume model means a plume model that integrates protective action guidance and other information as the Secretary determines appropriate.

F

Recovery

2161.

Recovery and restoration from a biological attack or incident guidance

(a)

Establishment of guidance

Not later than one year after the date of the enactment of this section, the Secretary, in coordination with the Administrator of the Environmental Protection Agency and in consultation with the Director of the Occupational Safety and Health Agency, and the Director of the National Institute for Occupational Safety and Health, shall develop and issue guidance for clean-up and restoration of indoor and outdoor areas, including subways and other mass transportation facilities, that have been affected by a biological attack or event.

(b)

Contents

The guidance developed under subsection (a) shall include—

(1)

acceptable levels of growth of the organism in post-remediation area samples from affected sites;

(2)

standards for effective clean-up of affected sites;

(3)

standards for safe post-event occupancy of affected sites;

(4)

requirements to ensure that the decontamination procedures for responding organizations do not conflict;

(5)

requirements that each responding organization uses a uniform system for tracking costs and performance of clean-up contractors;

(6)

levels of personal protection equipment;

(7)

maintenance of negative air pressure in buildings;

(8)

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 Secretary shall—

(1)

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

(2)

make revisions to the guidance as appropriate; and

(3)

make the revised guidance available to the Federal government, State, local, and tribal authorities, nongovernmental organizations, the private sector, and the public.

(d)

Procedures for developing and revising guidance

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

(1)

inventory existing relevant guidance;

(2)

enable the public to submit recommendations of areas in which guidance is needed;

(3)

determine which entities should be consulted in developing or revising the guidance;

(4)

prioritize, on a regular basis, guidance that should be developed or revised; and

(5)

develop and disseminate the guidance in accordance with the prioritization under paragraph (4).

(e)

Consultations

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

(1)

the heads of other Federal departments and agencies, as appropriate;

(2)

State, local, and tribal 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 committees with—

(1)

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

(2)

any guidance in effect on the date of the report;

(3)

a list of entities to which the guidance described in paragraph (2) were disseminated;

(4)

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

(5)

the prioritized list of the guidance required under subsection (d)(4), and the methodology used by the Secretary for such prioritization; and

(6)

a plan for developing, revising, and disseminating the guidance.

.

(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:

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.

202.

Definitions

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

(19)

The term weapon of mass destruction has the meaning given that term in section 1403(1) fo the Defense Against Weapons of Mass Destruction Act of 1996 (50 U.S.C. 2302).

(20)

The term Intelligence Community has the meaning given that term in section 3(4) of the National Security Act of 1947 (50 U.S.C. 401a(4)).

(21)

The term national biosecurity and biodefense stakeholders means officials from the Federal, State, local, and tribal authorities and individuals from the private sector who are involved in efforts to prevent, deter, prepare for, detect, attribute, respond, and recover from a biological attack or other phenomena that may have serious health consequences for the United States, including wide-scale fatalities or infectious disease outbreaks.

(22)

The term Tier I Material Threat Agent means a substance so designated under section 351A(a)(2) of the Public Health Service Act or section 212(a)(2) of the Agricultural Bioterrorism Protection Act of 2002.

.

203.

Dual-use terrorist risks from synthetic genomics

(a)

Sense of congress

It is the sense of Congress that the field of synthetic genomics has the potential to facilitate enormous gains in fundamental discovery and biotechnological applications, but it also has inherent dual-use homeland security risks that must be managed.

(b)

Requirement

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 report 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 synthetic nucleic acid providers to effectively differentiate a legitimate customer from a potential terrorist or other malicious actor;

(2)

determining the current capability of synthetic nucleic acid providers to effectively screen orders for sequences of homeland security concern; and

(3)

making recommendations regarding screening software, protocols, and other remaining capability gaps uncovered by the study.

204.

Dissemination of information analyzed by the Department to State, local, tribal, and private entities with responsibilities relating to homeland security

(a)

Responsibilities of the Secretary

Section 201(d)(8) of the Homeland Security Act of 2002 (6 U.S.C. 121(d)(8)) is amended by striking and to agencies of State and all that follows and inserting to State, local, tribal, and private entities with such responsibilities, and, as appropriate, to the public, in order to assist in preventing, deterring, or responding to acts of terrorism against the United States..

(b)

Report

Not later than one year after the date of the enactment of this Act, the Secretary of Homeland Security shall submit to the appropriate congressional committees a report on the implementation of this section.

205.

National Biosurveillance Integration Center (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 following: the Office of Intelligence and Analysis.;

(2)

in subsection (d)(2)(B)—

(A)

by inserting and disseminate after integrate; and

(B)

by inserting , including information and intelligence generated elsewhere within the Office of Intelligence and Analysis and the Department, after information ;

(3)

in subsection (e)(1), by striking subparagraph (A) and inserting the following new subparagraph (A):

(A)

integrate biosurveillance information into the NBIC, with the goal of promoting information sharing between Federal, State, local, and tribal authorities to detect biological attacks and events of homeland concern;

;

(4)

by amending paragraph (2) of subsection (f) to read as follows:

(2)

Detail of personnel

The head of a participating Federal department or agency shall detail, on a reimbursable basis, any of the personnel of that department or agency to the Department to assist the NBIC in carrying out this section.

; and

(5)

by redesignating subsection (j) as subsection (k) and inserting after subsection (i) the following new subsection (j):

(j)

Annual report

Not later than one year after the date of the enactment of the WMD Prevention and Preparedness Act of 2010 and annually thereafter, the Secretary shall submit to the appropriate congressional committees a report on—

(1)

the status of operations at the National Biosurveillance Integration Center of the Department under section 316;

(2)

efforts by the Office of Intelligence and Analysis to take responsibility for the National Biosurveillance Integration Center; and

(3)

efforts to integrate the biosurveillance efforts of Federal, State, local, and tribal authorities.

.

206.

Report on establishment of the system assessment and validation for emergency responders (SAVER) program

Not later than one year after the date of the enactment of this Act, the Secretary of Homeland Security shall submit to the appropriate congressional committees a report on the SAVER Program under section 2134 of the Homeland Security Act of 2002, as added by section 201.

207.

National Academy of Sciences study of forensic science in homeland security

(a)

Study

Not later than 90 days after the date of the enactment of this Act, the Secretary of Homeland Security, acting through the Under Secretary of Homeland Security for Science and Technology, shall seek to enter into an agreement with the National Academy of Sciences to—

(1)

conduct a study, building on previous studies conducted by the National Academy of Sciences, on the role of forensic science in homeland security; and

(2)

issue recommendations to enhance this homeland security capability to investigate attacks from weapons of mass destruction, terrorist incidents, and other crimes investigated by the Department.

(b)

Report

Not later than two years after the date of the enactment of this Act, the Secretary shall submit to the appropriate congressional committees a report containing the results of the National Academy of Sciences study required under subsection (a), together with any recommendations of the Secretary related thereto.

(c)

Authorization of appropriations

There is authorized to be appropriated to the Department, for fiscal year 2011, $1,000,000 to carry out this section.

208.

Harmonization of regulations

(a)

Regulations under Public Health Service Act

Not later than one year after the Secretary of Homeland Security promulgates regulations or amendments thereto to carry out section 2104 of the Homeland Security Act of 2002, as added by section 201, the Secretary of Health and Human Services shall amend regulations promulgated under the Select Agent Program under section 351A(b)(1) of the Public Health Service Act (42 U.S.C. 262a(b)(1)) to ensure that such regulations are not redundant or are not in conflict with the regulations promulgated by the Secretary under such section 2104.

(b)

Regulations under agriculture bioterrorism protection act of 2002

Not later than one year after the Secretary of Homeland Security promulgates regulations or amendments thereto pursuant to such section 2104, the Secretary of Agriculture shall amend regulations promulgated under the Select Agent Program under section 212(b)(1) of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401(b)(1)) to ensure that such regulations are not redundant or are not in conflict with the regulations promulgated by the Secretary under such section 2104.

209.

Communications planning for weapons of mass destruction information dissemination

(a)

Communications plans required

Section 653 of the Post-Katrina Emergency Management Reform Act of 2006 (6 U.S.C. 753) is amended—

(1)

in subsection (a)(4), by inserting after man-made disasters the following , and a communications plan described in subsection (f); and

(2)

by adding at the end the following new subsection:

(f)

Communications plan

(1)

In general

A communications plan developed under subsection (a)(4) shall be designed to provide information to the public related to preventing, preparing for, and responding to attacks from weapons of mass destruction and acts of terrorism;

(2)

Consultation

As appropriate, the Administrator shall consult with State, local, and tribal authorities and coordinate with other Federal departments 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 messages 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 of, during, or in the immediate aftermath of an attack from a weapon of mass destruction or terrorist incident, and to be included in the Department of Homeland Security’s Lessons Learned Information Sharing system.

(B)

Development and design

The pre-scripted messages or message templates shall—

(i)

be developed in consultation with State, local, and tribal authorities and in coordination with other appropriate Federal departments and agencies;

(ii)

be designed to provide accurate, essential, and appropriate information and instructions to the population directly affected by an incident, including information regarding an evacuation, sheltering in place, hospital surge operations, health, and safety; and

(iii)

be designed to provide accurate, essential, and appropriate information and instructions to emergency response providers and medical personnel responding to an incident.

(C)

Communications formats

The Administrator shall develop pre-scripted messages or message templates under this paragraph in multiple formats to ensure delivery—

(i)

in cases where the usual communications infrastructure is unusable; and

(ii)

to individuals with disabilities or other special needs and individuals with limited English proficiency.

(D)

Dissemination and technical assistance

The Administrator shall ensure that all pre-scripted messages and message templates developed under this paragraph are made available to State, local, and tribal authorities so that those authorities may incorporate them, as appropriate, into their emergency plans. The Administrator shall also make available relevant technical assistance to those authorities to support communications planning.

(E)

Exercises

To ensure that the pre-scripted messages or message templates developed under this paragraph can be effectively utilized in a disaster or incident, the Administrator shall incorporate such pre-scripted messages or message templates into exercises conducted under the National Exercise Program described in section 648 of the Post-Katrina Emergency Management Reform Act of 2006 (6 U.S.C. 748).

.

(b)

Report

Not later than one year after the date of the enactment of this Act, the Administrator shall submit to the appropriate congressional committees the communications plans required to be developed under the amendments made by subsection (a), including pre-scripted messages or message templates developed in conjunction with the plans and a description of the means that will be used to deliver these messages during such incidents.

210.

Environmental recovery from chemical, biological, radiological, and nuclear attacks

(a)

In general

To facilitate environmental recovery from a chemical, biological, radiological, or nuclear attack or other incident involving chemical, biological, radiological, or nuclear materials and to foster collective response to terrorism, the Administrator of the Environmental Protection Agency, in coordination with the Administrator of the Federal Emergency Management Agency, shall assess capability gaps in environmental recovery preparedness and provide guidance to State, local, and tribal authorities.

(b)

Requirements

In carrying out subsection (a), the Administrator of the Environmental Protection Agency shall—

(1)

assess capability gaps in the Nation’s ability to recover from chemical, biological, radiological, and nuclear attacks or incidents, with specific attention to—

(A)

decontamination standards, gaps in such standards, and recommendations for research to minimize these gaps;

(B)

environmental remediation methods; and

(C)

such other components as determined by the Secretary;

(2)

disseminate guidance to State, local, and tribal authorities that conforms to the goals of the National Disaster Recovery Strategy as required in Section 682 of the Department of Homeland Security Appropriations Act, 2007 (Public Law 109–295; 6 U.S.C. 771) regarding how to conduct environmental remediation of contaminated areas, including—

(A)

clarification of Federal roles and responsibilities for assisting State, local, and tribal authorities; and

(B)

such other guidance as determined by the Secretary; and

(3)

develop exercises in consultation with State, local, and tribal authorities and other appropriate Federal agencies, to enhance collective response to and recovery from chemical, biological, radiological and nuclear attacks and incidents, including exercises that address analysis, environmental cleanup methods, and decontamination standards.

(c)

Report

Not later than one year after the date of the enactment of this Act, the Administrator of the Environmental Protection Agency shall submit to the appropriate congressional committees a report on the Administrator’s assessment under section 2162 of the Homeland Security Act of 2002, as added by section 201.

211.

University-based centers for homeland security 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 inserting before the period at the end the following , including medical readiness training and research, and community resiliency for public health and healthcare critical infrastructure.

III

Public Health Matters

301.

National medical countermeasure dispensing strategy

Title III of the Public Health Service Act is amended by inserting after section 319F–4 (42 U.S.C. 247d–6e) the following:

319F–5.

National medical countermeasure dispensing strategy

(a)

Definitions

In this section—

(1)

the term dispense means to provide medical countermeasures to an affected population in response to a threat or incident; and

(2)

the term medical countermeasure means a qualified countermeasure (as defined in section 319F–1(a)(2)).

(b)

Strategy

The Secretary, in coordination with the Secretary of Homeland Security, the Secretary of Agriculture, and other appropriate Federal agencies, shall develop, implement, and, as appropriate, periodically update a National Medical Countermeasure Dispensing Strategy to enhance preparedness and collective response to a terrorist attack on humans or animals with any chemical, biological, radiological, or nuclear material.

(c)

Coordination

Where appropriate, the Secretary shall coordinate with State, local, and tribal authorities, private sector, and nongovernmental organizations on the National Medical Countermeasures Dispensing Strategy.

(d)

Report

Not later than one year after the date of the enactment of this section, the Secretary, in coordination with the Secretary of Homeland Security, shall submit the National Medical Countermeasures Dispensing Strategy to the appropriate congressional committees.

.

302.

Material threat assessments and determinations

Section 319F–2(c)(2)(A) of the Public Health Service Act (42 U.S.C. Sec 247d-6b(c)(2)(A)) is amended—

(1)

in clause (i), by striking and at the end;

(2)

in clause (ii), by striking the period at the end and inserting ; and; and

(3)

by adding at the end the following:

(iii)

review and reassess determinations under clause (ii) to determine whether agents continue to present a material threat against the United States population sufficient to affect national security and homeland security.

.

303.

National pre-event vaccination and antimicrobial dispensing policy review

(a)

Requirement

The Secretary of Health and Human Services, in coordination with the Secretary of Homeland Security, shall review the adequacy of domestic vaccination and antimicrobial dispensing policy, guidance, and information provided to the public in light of any known terrorist risk of a biological attack or other phenomena that may have serious health consequences for the United States, including wide-scale fatalities or infectious disease outbreaks. In carrying out the review under this section, the Secretary shall consider—

(1)

material threat assessments and determinations conducted by the Department of Homeland Security;

(2)

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

(3)

the availability of domestic vaccine and antimicrobials to dispense to the public, on a voluntary basis, in anticipation of a biological attack; and

(4)

making surplus or expiring domestic vaccine and antimicrobials available to State, local, and tribal emergency responders, including health care responders, on a voluntary basis.

(b)

Report

Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to the appropriate congressional committees a report on the review required by subsection (a), together with any recommendations relating to the availability of domestic vaccine and antimicrobials for disbursing to the public and voluntary immunization by first responders.

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 paragraph (3);

(2)

by inserting after paragraph (1) the following:

(2)

Tier I Material Threat Agents

(A)

Designation of Tier I: material threat agents

Not later than 1 year after the date of the enactment of this paragraph, the Secretary, in coordination with the Secretary of Homeland Security and other Federal officials as appropriate, shall by regulation designate as Tier I Material Threat Agents those agents and toxins—

(i)

that—

(I)

are determined by the Secretary of Homeland Security under section 319F-2(c)(2) to present a material threat against the United States population sufficient to affect national security; and

(II)

are determined to warrant designation after applying the criteria in subparagraph (B); or

(ii)

that clearly present a material threat to the Nation as otherwise determined by the Secretary or the Secretary of Homeland Security.

(B)

Criteria

In determining whether to designate an agent or toxin as a Tier I Material Threat Agent under subparagraph (A)(i), the Secretary, in coordination with the Secretary of Homeland Security, shall consider—

(i)

whether the agent or toxin can be used effectively in a biological attack;

(ii)

information available from any biological or bioterrorism risk assessments conducted by the Department of Homeland Security and relevant assessments by other agencies; and

(iii)

such other criteria and information as the Secretary, in coordination with the Secretary of Homeland Security, determines appropriate and relevant.

(C)

Inclusion of agents and toxins not previously listed

All agents or toxins designated by the Secretary as Tier I Material Threat Agents shall be included on the list maintained by the Secretary pursuant to paragraph (1).

(D)

Evaluation of Tier I Material Threat Agents

The Secretary, in coordination with the Secretary of Homeland Security, shall—

(i)

on an ongoing basis, consider the inclusion of additional agents or toxins on the list of Tier I Material Threat Agents, as appropriate; and

(ii)

at least biennially, review the list of Tier I Material Threat agents to determine whether any agents or toxins should be removed from the list.

; and

(3)

in paragraph (3), as so redesignated—

(A)

by striking list under paragraph (1) and inserting lists under paragraphs (1) and (2); and

(B)

by striking revise the list and inserting revise the lists.

(b)

Agricultural Bioterrorism Protection Act of 2002

Section 212(a) of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401(a)) is amended—

(1)

by redesignating paragraph (2) as paragraph (3);

(2)

by inserting after paragraph (1) the following:

(2)

Tier I material threat agents

(A)

Designation of Tier I: material threat agents

Not later than one year after the date of the enactment of this paragraph, the Secretary, in coordination with the Secretary of Homeland Security, the Secretary of Health and Human Services, and other Federal officials as appropriate, shall by regulation designate as Tier I Material Threat Agents those agents and toxins—

(i)

that—

(I)

are determined by the Secretary of Homeland Security under section 319F-2(c)(2) of the Public Health Service Act to present a material threat against the United States population sufficient to affect national security; and

(II)

are determined to warrant designation after applying the criteria in subparagraph (B); or

(ii)

that clearly present a material threat to the Nation as otherwise determined by the Secretary or the Secretary of Homeland Security.

(B)

Criteria

In determining whether to designate an agent or toxin as a Tier I Material Threat Agent under subparagraph (A)(i), the Secretary, in coordination with the Secretary of Homeland Security, shall consider—

(i)

whether the agent or toxin can be used effectively in a biological attack;

(ii)

information available from any biological or bioterrorism risk assessments conducted by the Department of Homeland Security and relevant assessments by other agencies; and

(iii)

such other criteria and information that the Secretary, in coordination with the Secretary of Homeland Security, determines appropriate and relevant.

(C)

Inclusion of agents and toxins not previously listed

All agents or toxins designated by the Secretary as Tier 1 Material Threat Agents shall be included on the list maintained by the Secretary pursuant to paragraph (1).

(D)

Evaluation of Tier I material threat agents

The Secretary, in coordination with the Secretary of Homeland Security, shall—

(i)

on an ongoing basis, consider the inclusion of additional agents or toxins on the list of Tier I Material Threat Agents, as appropriate; and

(ii)

at least biennially, review the list of Tier I Material Threat agents to determine whether any agents or toxins should be removed from the list.

; and

(3)

in paragraph (3), as so redesignated—

(A)

by striking list under paragraph (1) and inserting lists under paragraphs (1) and (2); and

(B)

by striking revise the list and inserting revise the lists.

305.

Background checks

Section 351A(e)(3)(A) of the Public Health Service Act (42 U.S.C. 262a(e)(3)(A)) is amended by adding at the end the following: In identifying whether an individual is within a category specified in subparagraph (B)(ii)(II), the Attorney General shall coordinate with the Secretary of Homeland Security, the Secretary of Defense, and the Secretary of State to determine whether these officials possess any information relevant to the identification of such an individual by the Attorney General..

306.

Biotechnology research, development, and procurement

Title III of the Public Health Service Act is amended by inserting after section 319M (42 U.S.C. 247d–f) the following:

319N.

Biotechnology research, development, and procurement

(a)

In general

The Secretary shall develop a comprehensive research, development, and acquisition process to counter the biological threat that employs the inherent functions, capabilities, authorities, and responsibilities of NIH, BARDA, and Project BioShield. The process shall—

(1)

assign NIH responsibility for research and development of technologies that range in development from basic principles observed and reported up to model or prototype demonstration in a relevant environment;

(2)

assign BARDA responsibility for research and development of technologies that range in development from model or prototype demonstration in a relevant environment up to a system qualified for application through successful test and demonstration;

(3)

assign Project BioShield responsibility for procurement of technologies that—

(A)

are qualified for application through successful test and demonstration; and

(B)

meet the minimum statutory requirements for emergency use authorization in section 564 of the Federal Food, Drug, and Cosmetic Act; and

(4)

include a formal agreement among NIH, BARDA, and Project BioShield that—

(A)

identifies the need for any specific biological countermeasure, derived from information developed under section 319F–2;

(B)

identifies the current technology readiness level of the countermeasure; and

(C)

requires the development of the biological countermeasure from the current technology readiness level through the procurement of the countermeasure in accordance with paragraph (3).

(b)

Responsibility of NIH

For countermeasures identified under subsection (a)(4)(A) that have a level of development from basic principles observed and reported up to model or prototype demonstration in a relevant environment, the Director of NIH shall conduct research and development until the Director certifies to the Secretary of Health and Human Services that—

(1)

the countermeasure has completed model or prototype demonstration in a relevant environment; or

(2)

the Director does not believe that completion of model or prototype demonstration in a relevant environment is reasonably achievable.

(c)

Responsibility of BARDA

For countermeasures identified under subsection (a)(4)(A) that have a level of development of model or prototype demonstration in a relevant environment, including but not limited to those countermeasures certified to have that level of development by the Director of NIH, the Director of BARDA shall conduct research and development until the Director of BARDA certifies to the Secretary of Health and Human Services that—

(1)

the countermeasure has qualified for application through successful test and demonstration; or

(2)

the Director does not believe that qualification for application through successful test and demonstration is reasonably achievable.

(d)

Responsibility of Project BioShield

For countermeasures identified under subsection (a)(4)(A) that are qualified for application through successful test and demonstration, including but not limited to those countermeasures certified to have qualified for application through successful test and demonstration by the Director of BARDA, the Assistant Secretary of Health and Human Services for Preparedness and Response shall use the Project BioShield special reserve fund to may procure the countermeasure if the countermeasure meets the requirements for emergency use authorization described in subsection (a)(3)(B).

(e)

No requirement for Food and Drug Administration general use approval

The Secretary shall ensure that the Directors of NIH and BARDA and the Assistant Secretary of Health and Human Services for Preparedness and Response do not discontinue any research, development, or procurement of a countermeasure identified under subsection (a)(4)(A) because the Food and Drug Administration has not, or decides against, approving or licensing the countermeasure for general use under chapter V of the Federal Food, Drug, and Cosmetic Act or section 351 of this Act, as applicable.

(f)

Innovation

The Secretary shall require the Directors of NIH and BARDA and the Assistant Secretary of Health and Human Services for Preparedness and Response to aggressively pursue innovative research, development, and procurement of each countermeasure identified under subsection (a)(4)(A).

(g)

Definitions

In this section:

(1)

The term BARDA means the he Biomedical Advanced Research and Development Authority established under section 319L(c).

(2)

The term NIH means the National Institutes of Health.

(3)

The term Project Bioshield means the Federal medical countermeasure procurement program established by Public Law 108–276.

.

IV

Foreign Relations Matters

401.

International collaboration and information sharing relating to biosecurity

The Secretary of State, in coordination with the Secretary of Homeland Security, the Secretary of Agriculture, the Secretary of Health and Human Services, and the heads of other appropriate Federal agencies, shall—

(1)

support efforts in other countries and regions to develop mechanisms and capabilities for reporting to United Nations organizations validated data on biological attacks or other phenomena that may have serious health consequences for the United States, including wide-scale fatalities or infectious disease outbreaks;

(2)

engage other Federal and nongovernmental entities and other countries to advance awareness and understanding of the risk posed by information derived from the life sciences that has the potential for misuse to cause harm, and advance recommendations on how best to address such risk;

(3)

engage such entities and countries to promote greater awareness and understanding of the global availability of and access to life science technologies and materials; and

(4)

promote the development and use of mechanisms for reporting, preserving, and sharing data on Federal programs and investments in international scientific, agricultural, medical, and public health collaborations in support of efforts to enhance global biosecurity.

402.

International engagement to enhance biodefense and biosecurity

The Secretary of State, in coordination and consultation with the Secretary of Homeland Security, and the heads other appropriate Federal agencies, shall, as appropriate—

(1)

support efforts of other countries to establish and build capacity to effectively implement legislation criminalizing the development or use of biological weapons or acts of bioterrorism;

(2)

engage other countries and international nongovernmental entities to develop and establish common standards, guidance, and best practices for actions relevant to preventing acts of bioterrorism and the illicit use of life sciences;

(3)

support the efforts of other countries to enhance biosecurity and safety practices at laboratories and other facilities with materials that could be used in biological weapons or in an act of bioterrorism;

(4)

promote the development and adoption of international guidance for the safety and security of high-risk pathogens and toxins; and

(5)

promote information sharing relating to threats and best practices between the intelligence community, Federal law enforcement, and international law enforcement and security officials.

403.

Interagency task force on best practices for global biopreparedness

(a)

Sense of Congress

It is the sense of Congress that preparedness for a chemical, biological, radiological, or nuclear incident must be undertaken not only domestically but also internationally. Specifically, there is a need for a global preparedness architecture for such an event. Congress supports efforts to provide an international forum for discussion of key health security policies with international dimensions, and the establishment of a formal United States interagency task force to develop best practices and recommendations for implementation of a global preparedness architecture could enhance global preparedness.

(b)

Establishment of task force

The Secretary of State shall convene and lead an interagency task force to examine—

(1)

the state of global biopreparedness for a major biological event;

(2)

necessary components of a global biopreparedness architecture that would advance international health security, including considerations of—

(A)

risk assessments;

(B)

prevention and deterrence;

(C)

detection;

(D)

regional stockpiling of medical countermeasures, including considerations of—

(i)

security of the stockpile;

(ii)

delivery planning; and

(iii)

legal dimensions of and obstacles to implementing such an architecture;

(E)

attribution;

(F)

response;

(G)

other elements that should be a component of such an architecture; and

(H)

obstacles to implementing such an architecture;

(3)

best practices for preparedness based on lessons learned from domestic efforts to address the above issues, and that may be applicable internationally;

(4)

activities undertaken through the National Strategy for Countering Biological Threats and the International Health Regulations 2005, as well as other activities deemed relevant by the task force; and

(5)

the utility of working through existing international forums as a mechanism for distributing this information to the international community.

(c)

Membership

Members of the task force shall include representatives from—

(1)

the Department of Homeland Security;

(2)

the Department of Health and Human Services, including the Centers for Disease Control and Prevention;

(3)

the Department of Agriculture;

(4)

the Department of Defense;

(5)

the Department of Justice;

(6)

the Department of State;

(7)

the United States Agency for International Development;

(8)

the Director of National Intelligence;

(9)

other Federal Departments and agencies, as determined appropriate by the Secretary; and

(10)

other national biosecurity and biodefense stakeholders, including private sector, including the pharmaceutical industry and the biological laboratory community, as determined appropriate by the Secretary.

(d)

Report

Not later than 18 months after the date of the enactment of this Act, the Secretary shall submit to the appropriate congressional committees a report on the findings of the task force established under this section.

404.

Biological and Toxin Weapons Convention

The Secretary of State shall—

(1)

promote confidence in effective implementation of and compliance with the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (commonly referred to as the Biological and Toxin Weapons Convention) by the States party to the Convention by promoting transparency with respect to legitimate activities and pursuing compliance diplomatically to address concerns;

(2)

promote universal membership in the Convention;

(3)

develop an action plan for increasing international adherence to the Convention; and

(4)

ensure that United States participation in Convention meetings is broadly inclusive of representatives of relevant Federal departments and agencies.

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