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HR 5498 IHRHCommentsClose CommentsPermalink

111th CONGRESSCommentsClose CommentsPermalink

2d SessionCommentsClose CommentsPermalink

H. R. 5498CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

IN THE HOUSE OF REPRESENTATIVESCommentsClose CommentsPermalink

June 10, 2010CommentsClose CommentsPermalink

Mr. PASCRELL (for himself, Mr. KING of New York, Mr. THOMPSON of Mississippi, Ms. CLARKE, and Mr. DANIEL E. LUNGREN of California) introduced the following bill; which was referred to the Committee on Homeland Security, and in addition to the Committees on Energy and Commerce, Agriculture, Transportation and Infrastructure, Foreign Affairs, and Select Intelligence (Permanent Select), for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concernedCommentsClose CommentsPermalink

A BILLCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title- This Act may be cited as the ‘WMD Prevention and Preparedness Act of 2010’. CommentsClose CommentsPermalink





(b) Table of Contents- The table of contents for this Act is as follows: CommentsClose CommentsPermalink





Sec. 1. Short title; table of contents. CommentsClose CommentsPermalink





Sec. 2. Definitions. CommentsClose CommentsPermalink

TITLE I--INTELLIGENCE MATTERS

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





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

TITLE II--HOMELAND SECURITY MATTERS

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





Sec. 202. Definitions. CommentsClose CommentsPermalink





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





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





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





Sec. 206. Deadline for completion of methods to rapidly screen travelers at ports of entry.Sec. 207. Report on establishment of the system assessment and validation for emergency responders (SAVER) program. CommentsClose CommentsPermalink





Sec. 2087. National Academy of Sciences study of forensic science in homeland security. CommentsClose CommentsPermalink





Sec. 2098. Harmonization of regulations. CommentsClose CommentsPermalink





Sec. 21009. Communications planning for weapons of mass destruction information dissemination. CommentsClose CommentsPermalink





Sec. 211. Report on0. Environmental recovery from chemical, biological, radiological, and nuclear attacks. CommentsClose CommentsPermalink

TITLE III--PUBLIC HEALTH MATTERS

Sec. 301. National medical countermeasure dispensing strategy. CommentsClose CommentsPermalink





Sec. 302. Material threat assessments and determinations. CommentsClose CommentsPermalink





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





Sec. 304. Designation of tier I1 material threat agents. CommentsClose CommentsPermalink





Sec. 305. Background checks. CommentsClose CommentsPermalink





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

TITLE IV--FOREIGN RELATIONS MATTERS

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





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





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





Sec. 404. Biological and Toxin Weapons Convention. CommentsClose CommentsPermalink

SEC. 2. DEFINITIONS.

In this Act: CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink





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





(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)). CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink

TITLE I--INTELLIGENCE MATTERS CommentsClose CommentsPermalink

SEC. 101. NATIONAL INTELLIGENCE STRATEGY FOR COUNTERING THE THREAT FROM WEAPONS OF MASS DESTRUCTION.

(a) Strategy- CommentsClose CommentsPermalink





(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-- CommentsClose CommentsPermalink





(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 CommentsClose CommentsPermalink





(B) a plan to implement such strategy. CommentsClose CommentsPermalink





(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’. CommentsClose CommentsPermalink





(b) Contents- The strategy required under subsection (a) shall-- CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





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





(3) identify and address domestic needs for analysis and collection including the development of innovative human and technical intelligence collection capabilities and techniques; and CommentsClose CommentsPermalink





(4) address each type of weapon of mass destruction as necessary and appropriate. CommentsClose CommentsPermalink





(c) Implementation Plan- The plan for implementing the strategy required under subsection (a) shall include-- CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





(3) actions necessary to provide open-source intelligence relating to weapons of mass destruction to-- CommentsClose CommentsPermalink





(A) appropriate Federal departments and agencies; CommentsClose CommentsPermalink





(B) State, local, and tribal governmentauthorities; and CommentsClose CommentsPermalink





(C) private entities; CommentsClose CommentsPermalink





(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-- CommentsClose CommentsPermalink





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





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





(5) assignments of roles and responsibilities to elements of the Intelligence Community to implement the strategy; and CommentsClose CommentsPermalink





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





(d) Coordination- The Director of National Intelligence shall, as the Director considers appropriate, coordinate with State, local, and tribal government officialauthorities, private sector, and nongovernmental organizations in the development of the National Intelligence Strategy for Countering the Threat from Weapons of Mass Destruction. CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink

SEC. 102. NATIONAL INTELLIGENCE STRATEGY FOR COUNTERING BIOLOGICAL THREATS.

(a) Strategy- CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink





(2) TITLE- The strategy required under paragraph (1) shall be known as the ‘National Intelligence Strategy for Countering Biological Threats’. CommentsClose CommentsPermalink





(b) Contents- The strategy required under subsection (a) shall-- CommentsClose CommentsPermalink





(1) include a plan for for plan for establishing in the Intelligence Community a cadre of-- CommentsClose CommentsPermalink





(A) collectors and analysts in all agencies in the Intelligence Community that are familiar with biological threats, biological science, and biotechnology; CommentsClose CommentsPermalink





(B) biological scientists; CommentsClose CommentsPermalink





(C) biotechologists; and CommentsClose CommentsPermalink





(D) experts with knowledge of the current state of technologies that could be used to develop a weapon of mass destruction; CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





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





(5) address domestic and international needs for analysis and collection; CommentsClose CommentsPermalink





(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 CommentsClose CommentsPermalink





(7) include a plan for ensuring the prioritization and sustained commitment of intelligence personnel and resources to address biological threats. CommentsClose CommentsPermalink





(c) Implementation Plan- The implementation plan for the strategy required under subsection (a) shall-- CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





(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-- CommentsClose CommentsPermalink





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





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





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





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





(6) a schedule for evaluating on a regular basis the efforts of the Intelligence Community and progress on understanding and countering biological threats. CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink

TITLE II--HOMELAND SECURITY MATTERS CommentsClose CommentsPermalink

SEC. 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: CommentsClose CommentsPermalink

‘TITLE XXI--WEAPONS OF MASS DESTRUCTION PREVENTION AND PREPAREDNESS CommentsClose CommentsPermalink

‘Subtitle A--Prevention and Deterrence CommentsClose CommentsPermalink

‘SEC. 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-- CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





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





‘(3) provide tailored analytical support on these threats to State, local, and tribal partners as authorities as well as members of the public health, scientific, and response communities; and CommentsClose CommentsPermalink





‘(4) perform other responsibilities, as assigned by the Secretary. CommentsClose CommentsPermalink





‘(b) Coordination- Where appropriate, the unit shall coordinate with others in the Intelligence Community, including the National Counter Proliferation Center. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink

‘SEC. 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-- CommentsClose CommentsPermalink





‘(1) to the greatest extent practicable, integrate into the homeland security and intelligence, intelligence, and information sharing process national biosecurity and biodefense stakeholders within Federal, State, local, tribal, and private sector communities;‘(2) develop ; CommentsClose CommentsPermalink





‘(2) develop an information sharing framework for homeland security intelligence and information sharing withe national biosecurity and biodefense stakeholders; CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(b) Coordination With Secretary of StateOther 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. CommentsClose CommentsPermalink

‘SEC. 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-- CommentsClose CommentsPermalink





‘(1) identify the threat, vulnerability, and consequences of a biological terrorist attack against the United States; CommentsClose CommentsPermalink





‘(2) consider terrorists as intelligent adversaries and take into account information regarding the decision-making processes of terroristtelligence and information regarding terrorist intentions, capabilities, plans, and actions; CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





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





‘(5) identify key knowledge and data gaps; CommentsClose CommentsPermalink





‘(6) define critical biodefense vulnerabilities; CommentsClose CommentsPermalink





‘(7) provide relative risk-based prioritization of agents for bioterrorism; and CommentsClose CommentsPermalink





‘(8) evaluate progress in implementing national biopreparedness policy. CommentsClose CommentsPermalink





‘(b) Requirement- The Secretary shall-- CommentsClose CommentsPermalink





‘(1) convene an interagency task force of relevant 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; CommentsClose CommentsPermalink





‘(2) engage with national biosecurity and biodefense stakeholders to obtain their input regarding the Assessments, as appropriate; and CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink

‘SEC. 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. CommentsClose CommentsPermalink





‘(b) Considerations- In conducting the terrorism risk assessments under subsection (a), the Secretary shall-- CommentsClose CommentsPermalink





‘(1) consult with Secretary of Energy, Secretary of Heath and Human Services, and the Nuclear Regulatory Commission; CommentsClose CommentsPermalink





‘(2) consider relevant studies previously prepared by other Federal agencies, or other reputable sources; CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





‘(4) consider the potential radiological dispersion device value of different radiological materials including availability, dispersability, and ease of handling of such materials; CommentsClose CommentsPermalink





‘(5) consider the vulnerability for theft or other procurement that different facilities represent; and CommentsClose CommentsPermalink





‘(6) consider the consequences of a successful radiological dispersion device attack, including risk of death or injury and economic losses. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink

‘SEC. 2105. ENHANCED BIOSECURITY MEASURES.

‘(a) Regulations- TAt 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-- CommentsClose CommentsPermalink





‘(1) standards for personnel surety programs; CommentsClose CommentsPermalink





‘(2) standards for biosecurity practices and training of responsible officials, laboratory personnel, and support personnel; CommentsClose CommentsPermalink





‘(3) standards for performing laboratory vulnerability assessments in collaboration with each facility; CommentsClose CommentsPermalink





‘(4) risk-based laboratory security performance standards; CommentsClose CommentsPermalink





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





‘(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. CommentsClose CommentsPermalink





‘(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: CommentsClose CommentsPermalink





‘(1) The Department. CommentsClose CommentsPermalink





‘(2) The Department of Health and Human Services. CommentsClose CommentsPermalink





‘(3) The Department of Agriculture. CommentsClose CommentsPermalink





‘(4) The Department of Defense. CommentsClose CommentsPermalink





‘(5) The Department of Energy. CommentsClose CommentsPermalink





‘(6) The Department of Justice. CommentsClose CommentsPermalink





‘(7) For-profit research institutions. CommentsClose CommentsPermalink





‘(8) Academic research institutions. CommentsClose CommentsPermalink





‘(9) Nonprofit research institutions CommentsClose CommentsPermalink





.‘(10) Other stakeholders, as the Secretary determines appropriate. CommentsClose CommentsPermalink





‘(c) Time Requirement- The procedures for the negotiated rulemaking referred to in subsection (a) shall be conducted in a timely manner to ensure that-- CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





‘(2) a final rule is promulgated not later than two years after the date of the enactment of this section. CommentsClose CommentsPermalink





‘(d) Factors Tto Be Considered- In developing proposed and final standards pursuant to the negotiated rulemaking referred to in subsection (a), the negotiated rulemaking committee shall consider-- CommentsClose CommentsPermalink





‘(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)); CommentsClose CommentsPermalink





‘(2) the National Science Advisory Board for Biosecurity (established under sectionsection 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 (Public Law 109-417; 120 Stat. 2851)); CommentsClose CommentsPermalink





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





‘(4) the Chemical Facility Anti-Terrorism Act of 2009; and CommentsClose CommentsPermalink





‘(5) representatives from the scientific communityviews from representatives of biosecurity and biodefense stakeholders for methods to minimize any disincentives to biological research arising from enhanced biosecurity measures. CommentsClose CommentsPermalink





‘(e) Implementation of Enhanced Biosecurity Measures- CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(4) SIMULTANEOUS LABORATORY INSPECTIONS- CommentsClose CommentsPermalink





‘(A) INSPECTION DATA SHARING AND ENFORCEMENT UNIFORMITY- The Secretary of Health and Human Services and 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 I1 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 Health and Human Services or the Secretary of AgricultureAgriculture or the Secretary of Health and Human Services about approaches to enhance security at specific laboratories. CommentsClose CommentsPermalink





‘(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, and the Secretary of Agriculture pursuant to section 212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002 shall be conducted simultaneously to the extent practicable. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink

‘SEC. 21056. 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. CommentsClose CommentsPermalink

‘SEC. 21067. 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 governmentauthorities that possess, use, or transfer Tier I Material Threat Agents, to enhance security at laboratories of such organizations and governments.‘(b) authorities. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink

‘SEC. 21078. 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 officials, including law enforcement officialauthorities, including law enforcement authorities and emergency response providers. CommentsClose CommentsPermalink





‘(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) and section 212(d)(2) of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401(d)(2)). CommentsClose CommentsPermalink





‘(c) Classified and Sensitive Information- The Secretary shall ensure that any information disseminated under this section is handled consistent with-- CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





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





‘(3) other relevant laws. CommentsClose CommentsPermalink

‘SEC. 21089. 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-- CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





‘(2) ensure that national biodefense and biosecuritysecurity 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. CommentsClose CommentsPermalink





‘(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). CommentsClose CommentsPermalink

‘SEC. 210910. 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-- CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





‘(A) illegally obtaining sensitive United States technology and munitions; and CommentsClose CommentsPermalink





‘(B) obtaining weapons of mass destruction components, precursors, and delivery systems, including-- CommentsClose CommentsPermalink





‘(i) United States military technical data, hardware, small arms and defense services; CommentsClose CommentsPermalink





‘(ii) dual-use technical data/source code and commodities; and CommentsClose CommentsPermalink





‘(iii) deemed exports; and CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





‘(A) educating companies and individuals on the export laws of the United States; CommentsClose CommentsPermalink





‘(B) discussing export licensing issues and requirements; CommentsClose CommentsPermalink





‘(C) identifying red flag indicators used in illegal procurement; CommentsClose CommentsPermalink





‘(D) identifying the government agencies responsible for the licensing of export-controlled commodities and technology; and CommentsClose CommentsPermalink





‘(E) establishing and fostering relationships whereby companies and individuals can report suspicious contacts or attempts to violate the export laws of the United States. CommentsClose CommentsPermalink





‘(b) National Export Enforcement Coordination Network- CommentsClose CommentsPermalink





‘(1) ESTABLISHMENT; MEMBERSHIP- There is established in the Department a National Export Enforcement Coordination Networkunit responsible for national export enforcement coordination that is managed by the Secretary. The Networkunit 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. CommentsClose CommentsPermalink





‘(2) RESPONSIBILITIES- The Networkunit shall carry out the following responsibilities: CommentsClose CommentsPermalink





‘(A) Coordinating law enforcement counter-proliferation investigations and intelligence counter-proliferation activities. CommentsClose CommentsPermalink





‘(B) Addressing licensing inquiries, reviews, requests, checks, and verifications. CommentsClose CommentsPermalink





‘(C) Conducting outreach and providing training to the export trade community. CommentsClose CommentsPermalink

‘Subtitle B--Preparedness CommentsClose CommentsPermalink

‘SEC. 2121. COMMUNICATION OF THREAT INFORMATION AND ALERTS.

‘(a) Findings- Congress makes the following findings: CommentsClose CommentsPermalink





‘(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’. CommentsClose CommentsPermalink





‘(2) There are unique challenges for community preparedness for attacks from weapons of mass destruction and their agents. CommentsClose CommentsPermalink





‘(b) Terrorism Threat Awareness- CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(2) THREAT BULLETINS- CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(B) REQUIREMENTS- Each assessment required under subparagraph (A) shall-- CommentsClose CommentsPermalink





‘(i) include guidance to the general public for preventing and responding to acts of terrorism; and CommentsClose CommentsPermalink





‘(ii) be made available on the Internet website of the Department and other publicly accessible Internet websites, communication systems, and information networks. CommentsClose CommentsPermalink





‘(3) GUIDANCE TO STATE, LOCAL, AND TRIBAL GOVERNMENTAUTHORITIES- The Secretary-- CommentsClose CommentsPermalink





‘(A) acting through the Administrator of the Federal Emergency Management Agency, shall provide to State, local, and tribal governmentauthorities written guidance on communicating terrorism-related threats and risks to the public within their jurisdictions; and CommentsClose CommentsPermalink





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





‘(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. CommentsClose CommentsPermalink

‘SEC. 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 governmentauthorities in improving and promoting individual and community preparedness and collective response to weapons of mass destruction and terrorist attacks involving biological, chemical, biological, radiological, and nuclear materials against the United States by-- CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





‘(2) disseminating the guidance developed under section 2151 to communities and individuals, as appropriate; CommentsClose CommentsPermalink





‘(3) compiling and disseminating information on best practices for individual and community preparedness;‘(4) providing information and training materials in support of individual and community preparedness efforts; CommentsClose CommentsPermalink





‘(54) conducting individual and community preparedness outreach efforts; and CommentsClose CommentsPermalink





‘(65) such other actions as the Secretary determines appropriate. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink

‘Subtitle C--Detection CommentsClose CommentsPermalink

‘SEC. 2131. NATIONAL BIOSURVEILLANCE STRATEGY.

‘(a) Current State of Biosurveillance- The Secretary shall examine of the state of domestic and global biosurveillance. CommentsClose CommentsPermalink





‘(b) Strategy for Biosurveillance- The Secretary shall submit to the appropriate congressional committees a national strategy for biosurveillance. CommentsClose CommentsPermalink





‘(c) Matters for Inclusion- CommentsClose CommentsPermalink





‘(1) IN GENERAL- In developing the strategy required under subsection (b), the Secretary shall take into consideration-- CommentsClose CommentsPermalink





‘(A) the state of biosurveillance domestically and internationally; CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





‘(C) reports on global trends produced by the Office of the Director of National Intelligence regarding the biological threat, and Intelligence Community requirements;‘(D) information; CommentsClose CommentsPermalink





‘(D) information available in biosurveillance systems and changes to information technology to allow for the incorporation and integration of this information; CommentsClose CommentsPermalink





‘(E) Intelligence Community needs as articulated in relevant intelligence strategies; and CommentsClose CommentsPermalink





‘(F) costs associated with establishing and maintaining the necessary infrastructure to integrate biosurveillance systems. CommentsClose CommentsPermalink





‘(2) ADDITIONAL REQUIREMENTS- This strategy required under subsection (b) shall-- CommentsClose CommentsPermalink





‘(A) include a plan for advancing situational awareness; CommentsClose CommentsPermalink





‘(B) identify key elements of information to be shared, critical sensitivities to be protected, and a framework for enabling information exchange; CommentsClose CommentsPermalink





‘(C) include a plan for fostering information sharing between public health, law enforcement, security, intelligence, and the scientific communitienational biosecurity and biodefense stakeholders to identify potential threats, reduce vulnerabilities and improve collective response activities to and investigations of suspected biological attacks; and CommentsClose CommentsPermalink





‘(D) include strategic and implementation plans for the National Biosurveillance Integration Center under section 316. CommentsClose CommentsPermalink

‘SEC. 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-- CommentsClose CommentsPermalink





‘(1) deploy detectors to areas, based on risk, to indicate the presence of biological agents; CommentsClose CommentsPermalink





‘(2) provide information to participating laboratories for their use in monitoring public health, and biological material from these detectors to participating laboratories for testing; CommentsClose CommentsPermalink





‘(3) provide information about the presence of biological agents to public health and law enforcement personnel at all levels of government; and CommentsClose CommentsPermalink





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





‘(b) Program Requirements- Under the program required under subsection (a), the Secretary shall-- CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





‘(2) determine, on an annual basis, whether plans for biological detector capabilities and coverage sufficiently protect the United States population; and CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





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





‘(C) will be updated as necessary; CommentsClose CommentsPermalink





‘(D) shall require implementation of the standards developed under subparagraph (B) for all Department biomonitoringlogical detection programs; and CommentsClose CommentsPermalink





‘(E) shall make such standards available to support all other Federal biomonitoringlogical detection programs. CommentsClose CommentsPermalink





‘(c) Contract Authority- The Secretary is authorized to enter into contracts with participating laboratories for-- CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





‘(2) administrative and other costs related to hosting program personnel and equipment in these laboratories. CommentsClose CommentsPermalink





‘(d) Definitions- In this section: CommentsClose CommentsPermalink





‘(1) The term ‘participating laboratory’ means a laboratory that has been accepted as a member of the Laboratory Response Network for Bioterrorism that-- CommentsClose CommentsPermalink





‘(A) is fully equipped to detect and respond quickly to acts of biological terrorism; CommentsClose CommentsPermalink





‘(B) provides biocontainment and microbiological analysis in support of the Department, the Federal Bureau of Investigation and other law enforcement agencies with primary responsibilities for investigating biological incidents; and CommentsClose CommentsPermalink





‘(C) supports threat agent characterization studies and assay evaluation, research and development. CommentsClose CommentsPermalink





‘(2) The term ‘assay’ means any scientific test that is designed to detect the presence of a biological threat agent and is of a that is of a type selected under criteria established by the Secretary. CommentsClose CommentsPermalink

‘SEC. 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 weapons of mass destruction 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. CommentsClose CommentsPermalink





‘(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 weapons of mass destruction agents, pandemic influenza, and other infectious diseases. CommentsClose CommentsPermalink





‘(c) Collaboration- In developing methods under subsection (b), the Secretary may collaborate with the heads of other Federal agencies, as needed. CommentsClose CommentsPermalink

‘SEC. 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-- CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





‘(2) is supported by a network of scientists who perform the assessment and validation activities; CommentsClose CommentsPermalink





‘(3) provides results along with other relevant equipment information to the emergency response provider community in an operationally useful form; CommentsClose CommentsPermalink





‘(4) provides information on equipment that falls within the categories listed in the Department’s authorized equipment list; CommentsClose CommentsPermalink





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





‘(6) shares such information nationally with the emergency response provider community. CommentsClose CommentsPermalink

‘SEC. 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. CommentsClose CommentsPermalink

‘SEC. 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. CommentsClose CommentsPermalink





‘(b) Requirements- The Integrated Consortium of Laboratory Networks shall-- CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





‘(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, and to support effective all-hazard laboratory response; CommentsClose CommentsPermalink





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





‘(5) support threat agent characterization studies and assay evaluation, research, and development. CommentsClose CommentsPermalink

‘Subtitle D--Attribution CommentsClose CommentsPermalink

‘SEC. 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-- CommentsClose CommentsPermalink





‘(1) provide definitive forensic examination of biothreat agents and related evidence; CommentsClose CommentsPermalink





‘(2) provide necessary biocontainment; CommentsClose CommentsPermalink





‘(3) integrate bioforensics requirements for law enforcement, national security, and homeland security; CommentsClose CommentsPermalink





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





‘(5) develop national bioforensics standards; CommentsClose CommentsPermalink





‘(6) maintain the national bioforensics repository collection as a reference collection of biological agents and toxins for bioforensics comparisons and identifications; and CommentsClose CommentsPermalink





‘(7) support threat agent characterization studies and bioforensics assay evaluation research and development. CommentsClose CommentsPermalink





‘(b) National Bioforensics Repository Collection- CommentsClose CommentsPermalink





‘(1) IN GENERAL- The National Bioforensics Analysis Center shall maintain a distributed national bioforensics repository collection. CommentsClose CommentsPermalink





‘(2) ACTIVITIES- The national bioforensics repository collection shall-- CommentsClose CommentsPermalink





‘(A) receive, store, and distribute biological threat agents and toxins; CommentsClose CommentsPermalink





‘(B) serve as a distributed reference collection for comparative bioforensics identifications and characterizations; and CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(3) PARTICIPATION- CommentsClose CommentsPermalink





‘(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, which shall not include any variola virus but shall include any virus modified to include any part of the variola virus, to the national bioforensics repository collection. CommentsClose CommentsPermalink





‘(B) OTHER BIOLOGICAL AGENTS AND TOXINS- The Secretary shall require the contribution of public andto 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 to the national bioforensics repository collection that were collected or created with support from a Federal grant or contract and that support the functions described in paragraph (2). CommentsClose CommentsPermalink





‘(4) ACCESS- The Secretary shall-- CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(5) REPORT- CommentsClose CommentsPermalink





‘(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 to the national bioforensics 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. CommentsClose CommentsPermalink





‘(B) CONTENTS- The report submitted under subparagraph (A) shall-- CommentsClose CommentsPermalink





‘(i) discuss the status of the establishment of the national bioforensics distributed national bioforensics repository collection; CommentsClose CommentsPermalink





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





‘(iii) examine any access or participation issues affecting the establishment of the national bioforensics distributed national bioforensics repository collection or the ability to support bioforensics analysis, threat agent characterization studies, or bioforensics assay evaluation, research, and development, including-- CommentsClose CommentsPermalink





‘(I) intellectual property concerns; CommentsClose CommentsPermalink





‘(II) access to collected or created biological agent or toxin collections funded by a Federal grant or contract; CommentsClose CommentsPermalink





‘(III) costs associated with accessing, procuring, and securely transporting biological materials from domestic and international biological agent and toxin collections to the national bioforensics repository collection;‘(IV) 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 CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





‘(iv) other issues determined appropriate. CommentsClose CommentsPermalink





‘(c) National Bioforensics Strategy- CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(2) CONTENTS- The national bioforensics strategy shall-- CommentsClose CommentsPermalink





‘(A) provide for a coordinated approach across all executive agencies with responsibilities for-- CommentsClose CommentsPermalink





‘(i) conducting bioforensics examination of biological threat agents and related evidence; and CommentsClose CommentsPermalink





‘(ii) generating bioforensics requirements for law enforcement, national security, and homeland security; CommentsClose CommentsPermalink





‘(B) describe the roles and responsibilities of all relevant executive agencies, including-- CommentsClose CommentsPermalink





‘(i) research to characterize threat agents; CommentsClose CommentsPermalink





‘(ii) assay evaluation, research, and development; and CommentsClose CommentsPermalink





‘(iii) funding; CommentsClose CommentsPermalink





‘(C) establish mechanisms, in coordination with State, local, and tribal governmentauthorities, for coordinating with public health, environmental qualhomeland security, and law enforcement agencies for the collection or receipt, transfer, or submission of bioforensics evidence for analysis and its use; and CommentsClose CommentsPermalink





‘(D) include-- CommentsClose CommentsPermalink





‘(i) guidance for collecting, processing, and analyzing samples; CommentsClose CommentsPermalink





and‘(ii) requirements for reporting bioforensics information to appropriate agencies; and CommentsClose CommentsPermalink





‘(iii) requirements for the distributed national bioforensics repository collection. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





‘(2) bolstering the capabilities and information sharing activities of the National Bioforensics Analysis Center with national biosecurity and biodefense stakeholders. CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(fg) 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. CommentsClose CommentsPermalink

‘SEC. 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--‘(1) make training 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;‘(2, and shall-- CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





‘(32) promote the use of simulation among Federal partners to exercise capabilities, refine operational concepts, and strengthen relationships across the Government; and CommentsClose CommentsPermalink





‘(43) make training available that will ensure that law enforcement, public health, and agricultural investigations of biological threats are coordinated. CommentsClose CommentsPermalink

‘Subtitle E--Response CommentsClose CommentsPermalink

‘SEC. 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-- CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





and‘(2 ‘(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 CommentsClose CommentsPermalink





‘(3) make such guidance available to State, local, and tribal governmentauthorities, nongovernmental organizations, the private sector, and the public. CommentsClose CommentsPermalink





‘(b) Contents- The guidance developed under subsection (a)(1) shall include-- CommentsClose CommentsPermalink





‘(1) protective action guidance for ensuring the security, health, and safety of emergency response providers; CommentsClose CommentsPermalink





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





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





‘(c) Review and Revision of Guidance- The Secretary shall-- CommentsClose CommentsPermalink





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





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





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





‘(d) Procedures for Developing and Revising Guidance- In carrying out the requirements of this section, the Secretary shall establish procedures to-- CommentsClose CommentsPermalink





‘(1) inventory existing relevant hazardous material response guidance; CommentsClose CommentsPermalink





‘(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); CommentsClose CommentsPermalink





‘(3) determine which entities should be consulted in developing or revising the guidance; CommentsClose CommentsPermalink





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





‘(5) develop and disseminate the guidance in accordance with the prioritization under paragraph (4). CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





‘(1) the heads of other Federal departments and agencies, as appropriate; CommentsClose CommentsPermalink





‘(2) the National Advisory Council established under section 508; CommentsClose CommentsPermalink





‘(3) State, local, and tribal governments; and‘(4the National Domestic Preparedness Consortium; CommentsClose CommentsPermalink





‘(4) State, local, and tribal authorities; and CommentsClose CommentsPermalink





‘(5) nongovernmental organizations and private industry. CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





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





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





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





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





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





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

‘SEC. 2152. INTEGRATED PLUME MODELING FOR COLLECTIVE RESPONSE.

‘(a) Development- CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Secretary shall acquire, use, and disseminate timely integrated plume models to enable rapid response activities following a chemical, biological, nuclear, or radiological releaseattack or event. CommentsClose CommentsPermalink





‘(2) SCOPE- The Secretary shall-- CommentsClose CommentsPermalink





‘(A) ensure the rapid development and distribution of integrated plume models to appropriate officials of the Federal Government and State, local, and tribal governments to authorities to enable immediate response to a chemical, biological, or radiological incidattack or event; CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





‘(C) ensure that the development and dissemination of integrated plume models are assessed during exercises administered by the Department; and CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(3) CONSULTATION WITH OTHER DEPARTMENTS AND AGENCIES- In identifying and developing the integrated plume models described in this section, the Secretary shall consult, as appropriate, with--

‘(A) the Secretary of Defense, the Secretary of Energy, the Secretary of Health and Human Services, and the heads of other appropriate Federal agencies; and

‘(B) State, local, and tribal governments and nongovernmental organizations.

‘(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-- CommentsClose CommentsPermalink




‘(1) the developmentacquisition, use, and dissemination of integrated plume models under this section; CommentsClose CommentsPermalink





‘(2) lessons learned from assessing the development and dissemination of integrated plume models during exercises administered by the Department; and CommentsClose CommentsPermalink





‘(3) plans for improving the development and dissemination ofrecommendations for improving integrated plume models, as appropriate. CommentsClose CommentsPermalink





‘(c) Definitions- For purposes of this section: CommentsClose CommentsPermalink





‘(1) The term ‘plume model’ means the assessment of the location and prediction of the spread of nuclear, radioactive, or chemical fallout and biological pathogens resulting from a release ofagents following a chemical, biological, radiological, or nuclear materialsattack or event. CommentsClose CommentsPermalink





‘(2) The term ‘integrated plume model’ means a plume model that integrates protective action guidance and other information as the Secretary determines appropriate. CommentsClose CommentsPermalink

‘Subtitle F--Recovery CommentsClose CommentsPermalink

‘SEC. 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 the release of a biological agent.‘(b)a biological attack or event. CommentsClose CommentsPermalink





‘(b) Contents- The guidance developed under subsection (a) shall include-- CommentsClose CommentsPermalink





‘(1) acceptable levels of growth of the organism in post-remediation area samples from affected sites; CommentsClose CommentsPermalink





‘(2) standards for effective clean-up of affected sites; CommentsClose CommentsPermalink





‘(3) standards for safe post-event occupancy of affected sites; CommentsClose CommentsPermalink





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





‘(5) requirements that each responding organization uses a uniform system for tracking costs and performance of clean-up contractors; CommentsClose CommentsPermalink





‘(6) levels of personal protection equipment; CommentsClose CommentsPermalink





‘(7) maintenance of negative air pressure in buildings; CommentsClose CommentsPermalink





‘(8) standards for proper selection and use of personal protective equipment; CommentsClose CommentsPermalink





‘(9) proper use of personal protective equipment;‘(10) air sampling procedures; and CommentsClose CommentsPermalink





‘(110) how to develop occupational health and safety plans that are appropriate for the specific risk to responder health. CommentsClose CommentsPermalink





‘(c) Review and Revision of Guidance- The Secretary shall-- CommentsClose CommentsPermalink





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





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





‘(3) make the revised guidance available to the Federal Ggovernment, State, local, and tribal governmentauthorities, nongovernmental organizations, the private sector, and the public. CommentsClose CommentsPermalink





‘(d) Procedures for Developing and Revising Guidance- In carrying out the requirements of this section, the Secretary shall establish procedures to-- CommentsClose CommentsPermalink





‘(1) inventory existing relevant guidance; CommentsClose CommentsPermalink





‘(2) enable the public to submit recommendations of areas in which guidance is needed; CommentsClose CommentsPermalink





‘(3) determine which entities should be consulted in developing or revising the guidance; CommentsClose CommentsPermalink





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





‘(5) develop and disseminate the guidance in accordance with the prioritization under paragraph (4). CommentsClose CommentsPermalink





‘(e) Consultations- The Secretary shall develop and revise the guidance developed under subsection (a), and the procedures required under subsection (d), in consultation with-- CommentsClose CommentsPermalink





‘(1) the heads of other Federal departments and agencies, as appropriate; CommentsClose CommentsPermalink





‘(2) State, local, and tribal governmentauthorities; and CommentsClose CommentsPermalink





‘(3) nongovernmental organizations and private industry. CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





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





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





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





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





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





‘(6) a plan for developing, revising, and disseminating the guidance.‘SEC. 2162. 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 officials to recover from a chemical, biological, radiological or nuclear attack or incident.

‘(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 governments; 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.’. CommentsClose CommentsPermalink




(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: CommentsClose CommentsPermalink

‘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. CommentsClose CommentsPermalink

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

‘Sec. 2103. Bioterrorism risk assessments. CommentsClose CommentsPermalink

‘Sec. 2104. Radiological materials security. CommentsClose CommentsPermalink

‘Sec. 2105. Enhanced biosecurity measures. CommentsClose CommentsPermalink

‘Sec. 21056. Tier I Material Threat Agent locations. CommentsClose CommentsPermalink

‘Sec. 21067. High containment biological laboratory security grants. CommentsClose CommentsPermalink

‘Sec. 21078. Laboratory biosecurity information sharing. CommentsClose CommentsPermalink

‘Sec. 21089. Periodic homeland security review of criminal statutes. CommentsClose CommentsPermalink

‘Sec. 210910. Export enforcement for counter-proliferation. CommentsClose CommentsPermalink

‘Subtitle B--Preparedness

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

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

‘Subtitle C--Detection

‘Sec. 2131. National biosurveillance strategy. CommentsClose CommentsPermalink

‘Sec. 2132. Detection of biological attacks. CommentsClose CommentsPermalink

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

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

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

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

‘Subtitle D--Attribution

‘Sec. 2141. Bioforensics capabilities and strategy. CommentsClose CommentsPermalink

‘Sec. 2142. LFederal law enforcement training to investigate biological threats. CommentsClose CommentsPermalink

‘Subtitle E--Response

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

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

‘Subtitle F--Recovery

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

SEC. 202. DEFINITIONS.

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





‘(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). CommentsClose CommentsPermalink





‘(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)). CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(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.’. CommentsClose CommentsPermalink

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

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





(b) Requirement- The Secretary of Homeland 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 by not later than one year after the date of enactment of this Act on the homeland security 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-- CommentsClose CommentsPermalink





(1) determining the current capability of synthetic nucleic acid providers to effectively differentiate a legitimate customer from a potential terrorist or other malicious actor; CommentsClose CommentsPermalink





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





(3) making recommendations regarding screening software, protocols, and other remaining capability gaps uncovered by the study. CommentsClose CommentsPermalink

SEC. 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.’. CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink

SEC. 205. NATIONAL BIOSURVEILLANCE INTEGRATION CENTER (NBIC).

Section 316 of the Homeland Security Act of 2002 (6 U.S.C. 195b) is amended-- CommentsClose CommentsPermalink





(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.’; CommentsClose CommentsPermalink





(2) in subsection (d)(2)(B)-- CommentsClose CommentsPermalink





(A) by inserting ‘and disseminate’ after ‘integrate’; and CommentsClose CommentsPermalink





(B) by inserting ‘, including information and intelligence generated elsewhere within the Office of Intelligence and Analysis and the Department,’ after ‘information’ ; CommentsClose CommentsPermalink





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





‘(A) integrate biosurveillance information into the NBIC, with the goal of promoting information sharing between Federal, State, local, and tribal governmentauthorities to detect biological attacks and events of homeland concern;’; CommentsClose CommentsPermalink





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





‘(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 CommentsClose CommentsPermalink





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





‘(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-- CommentsClose CommentsPermalink





‘(1) the status of operations at the National Biosurveillance Integration Center of the Department under section 316; CommentsClose CommentsPermalink





‘(2) efforts by the Office of Intelligence and Analysis to take responsibility for the National Biosurveillance Integration Center; and CommentsClose CommentsPermalink





‘(3) efforts to integrate the biosurveillance efforts of Federal, State, local, and tribal governmentauthorities.’. CommentsClose CommentsPermalink

SEC. 206. DEADLINE FOR COMPLETION OF METHODS TO RAPIDLY SCREEN TRAVELERS AT PORTS OF ENTRY.

Not later than 90 days after the date of the enactment of this Act, the Secretary of Homeland Security shall complete the development of the methods to rapidly screen travelers at ports of entry, as required under subsection (b) of section 2133 of the Homeland Security Act of 2002, as added by section 201.

SEC. 207. 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. CommentsClose CommentsPermalink

SEC. 2087. 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-- CommentsClose CommentsPermalink





(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 CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink

SEC. 2098. 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 andor are not in conflict with the regulations promulgated by the Secretary under such section 2104. CommentsClose CommentsPermalink





(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 andor are not in conflict with the regulations promulgated by the Secretary under such section 2104. CommentsClose CommentsPermalink

SEC. 21009. 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-- CommentsClose CommentsPermalink





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





(2) by adding at the end the following new subsection: CommentsClose CommentsPermalink





‘(f) Communications Plan- CommentsClose CommentsPermalink





‘(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; CommentsClose CommentsPermalink





‘(2) CONSULTATION- As appropriate, the Administrator shall consult with State, local, and tribal governments and authorities and coordinate with other Federal departments and agencies in developing communications plans under paragraph (1). CommentsClose CommentsPermalink





‘(3) PRE-SCRIPTED MESSAGES AND MESSAGE TEMPLATES- CommentsClose CommentsPermalink





‘(A) IN GENERAL- The Administrator shall develop and disseminate pre-scripted messages and message templates to be provided to State, local, and tribal officialauthorities so that those officialauthorities 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. CommentsClose CommentsPermalink





‘(B) DEVELOPMENT AND DESIGN- The pre-scripted messages or message templates shall-- CommentsClose CommentsPermalink





‘(i) be developed in consultation with State, local, and tribal governmentauthorities and in coordination with other appropriate Federal departments and agencies; CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





‘(iii) be designed to provide accurate, essential, and appropriate information and instructions to emergency response providers and medical personnel responding to an incident. CommentsClose CommentsPermalink





‘(C) COMMUNICATIONS FORMATS- The Administrator shall develop pre-scripted messages or message templates under this paragraph in multiple formats to ensure delivery-- CommentsClose CommentsPermalink





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





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





‘(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 governmentauthorities so that those governmentauthorities may incorporate them, as appropriate, into their emergency plans. The Administrator shall also make available relevant technical assistance to those governments to support authorities to support communications planning. CommentsClose CommentsPermalink





‘(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).’. CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink

SEC. 211. REPORT ON0. 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. CommentsClose CommentsPermalink





(b) Requirements- In carrying out subsection (a), the Administrator of the Environmental Protection Agency shall-- CommentsClose CommentsPermalink





(1) assess capability gaps in the Nation’s ability to recover from chemical, biological, radiological, and nuclear attacks or incidents, with specific attention to-- CommentsClose CommentsPermalink





(A) decontamination standards, gaps in such standards, and recommendations for research to minimize these gaps; CommentsClose CommentsPermalink





(B) environmental remediation methods; and CommentsClose CommentsPermalink





(C) such other components as determined by the Secretary; CommentsClose CommentsPermalink





(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-- CommentsClose CommentsPermalink





(A) clarification of Federal roles and responsibilities for assisting State, local, and tribal authorities; and CommentsClose CommentsPermalink





(B) such other guidance as determined by the Secretary; and CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink

TITLE III--PUBLIC HEALTH MATTERS CommentsClose CommentsPermalink

SEC. 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: CommentsClose CommentsPermalink

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

‘(a) Definitions- In this section-- CommentsClose CommentsPermalink





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





‘(2) the term ‘medical countermeasure’ means a qualified countermeasure (as defined in section 319F-1(a)(2)). CommentsClose CommentsPermalink





‘(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 an terrorist attack on humans or animals with any chemical, biological, radiological, or nuclear material. CommentsClose CommentsPermalink





‘(c) Coordination- Where appropriate, the Secretary shall coordinate with State, local, and tribal government officialauthorities, private sector, and nongovernmental organizations on the National Medical Countermeasures Dispensing Strategy. CommentsClose CommentsPermalink





‘(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.’. CommentsClose CommentsPermalink

SEC. 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-- CommentsClose CommentsPermalink





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





(2) in clause (ii), by striking the period at the end and inserting ‘; and’; and CommentsClose CommentsPermalink





(3) by adding at the end the following: CommentsClose CommentsPermalink





‘(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.’. CommentsClose CommentsPermalink

SEC. 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-- CommentsClose CommentsPermalink





(1) material threat assessments and determinations conducted by the Department of Homeland Security; CommentsClose CommentsPermalink





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





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





(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. CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink

SEC. 304. DESIGNATION OF TIER I1 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)-- CommentsClose CommentsPermalink





(1) by redesignating paragraph (2) as paragraph (3); CommentsClose CommentsPermalink





(2) by inserting after paragraph (1) the following: CommentsClose CommentsPermalink





‘(2) TIER I MATERIAL THREAT AGENTS- CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





‘(i) that-- CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





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





‘(ii) that clearly present a material threat to the Nation as otherwise determined by the Secretary or the Secretary of Homeland Security. CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





‘(i) whether the agent or toxin can be used effectively in a biological attack; CommentsClose CommentsPermalink





‘(ii) information available from any biological or bioterrorism risk assessments conducted by the Department of Homeland Security and relevant assessments by other agencies; and CommentsClose CommentsPermalink





‘(iii) such other criteria and information as the Secretary, in coordination with the Secretary of Homeland Security, determines appropriate and relevant. CommentsClose CommentsPermalink





‘(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). CommentsClose CommentsPermalink





‘(D) EVALUATION OF TIER I MATERIAL THREAT AGENTS- The Secretary, in coordination with the Secretary of Homeland Security, shall-- CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





(3) in paragraph (3), as so redesignated-- CommentsClose CommentsPermalink





(A) by striking ‘list under paragraph (1)’ and inserting ‘lists under paragraphs (1) and (2)’; and CommentsClose CommentsPermalink





(B) by striking ‘revise the list’ and inserting ‘revise the lists’. CommentsClose CommentsPermalink





(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-- CommentsClose CommentsPermalink





(1) by redesignating paragraph (2) as paragraph (3); CommentsClose CommentsPermalink





(2) by inserting after paragraph (1) the following: CommentsClose CommentsPermalink





‘(2) TIER I MATERIAL THREAT AGENTS- CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





‘(i) that-- CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





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





‘(ii) that clearly present a material threat to the Nation as otherwise determined by the Secretary or the Secretary of Homeland Security. CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





‘(i) whether the agent or toxin can be used effectively in a biological attack; CommentsClose CommentsPermalink





‘(ii) information available from any biological or bioterrorism risk assessments conducted by the Department of Homeland Security and relevant assessments by other agencies; and CommentsClose CommentsPermalink





‘(iii) such other criteria and information that the Secretary, in coordination with the Secretary of Homeland Security, determines appropriate and relevant. CommentsClose CommentsPermalink





‘(C) INCLUSION OF AGENTS AND TOXINS NOT PREVIOUSLY LISTED- All agents or toxins designated by the Secretary as Tier I1 Material Threat Agents shall be included on the list maintained by the Secretary pursuant to paragraph (1). CommentsClose CommentsPermalink





‘(D) EVALUATION OF TIER I MATERIAL THREAT AGENTS- The Secretary, in coordination with the Secretary of Homeland Security, shall-- CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





‘(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 CommentsClose CommentsPermalink





(3) in paragraph (3), as so redesignated-- CommentsClose CommentsPermalink





(A) by striking ‘list under paragraph (1)’ and inserting ‘lists under paragraphs (1) and (2)’; and CommentsClose CommentsPermalink





(B) by striking ‘revise the list’ and inserting ‘revise the lists’. CommentsClose CommentsPermalink

SEC. 305. BACKGROUND CHECKS.

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

SEC. 306. BIOTECHNOLOGY RESEARCH, DEVELOPMENT, AND PROCUREMENT.

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

‘SEC. 319N. BIOTECHNOLOGY RESEARCH, DEVELOPMENT, AND PROCUREMENT.

‘(a) In General- The Secretary shall develop a comprehensive research, development, and acquisition process for counter-bioterrorismto counter the biological threat that employs the inherent functions, capabilities, authorities, and responsibilities of NIH, BARDA, and Project BioShield. The process shall-- CommentsClose CommentsPermalink





‘(1) assign NIH responsibility for research and development of counter-bioterrorism technologies that range in development from basic principles observed and reported up to model or prototype demonstration in a relevant environment; CommentsClose CommentsPermalink





‘(2) assign BARDA responsibility for research and development of counter-bioterrorism 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; CommentsClose CommentsPermalink





‘(3) assign Project BioShield responsibility for procurement of counter-bioterrorism technologies that-- CommentsClose CommentsPermalink





‘(A) are qualified for application through successful test and demonstration; and CommentsClose CommentsPermalink





‘(B) meet the minimum statutory requirements for emergency use authorization in section 564 of the Federal Food, Drug, and Cosmetic Act; and CommentsClose CommentsPermalink





‘(4) include a formal agreement among NIH, BARDA, and Project BioShield that-- CommentsClose CommentsPermalink





‘(A) identifies the need for any specific biological countermeasure, derived from information developed under section 319F-2; CommentsClose CommentsPermalink





‘(B) identifies the current technology readiness level of the countermeasure; and CommentsClose CommentsPermalink





‘(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). CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





‘(1) the countermeasure has completed model or prototype demonstration in a relevant environment; or CommentsClose CommentsPermalink





‘(2) the Director does not believe that completion of model or prototype demonstration in a relevant environment is reasonably achievable. CommentsClose CommentsPermalink





‘(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-- CommentsClose CommentsPermalink





‘(1) the countermeasure has qualified for application through successful test and demonstration; or CommentsClose CommentsPermalink





‘(2) the Director does not believe that qualification for application through successful test and demonstration is reasonably achievable. CommentsClose CommentsPermalink





‘(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). CommentsClose CommentsPermalink





‘(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. CommentsClose CommentsPermalink





‘(f) Entrepreneurial Risk- The Secretary shallInnovation- The Secretary shall require the Directors of NIH and BARDA and the Assistant Secretary of Health and Human Services for Preparedness and Response to demonstrate a reasonably aggressive level of entrepreneurial risk inaggressively pursue innovative research, development, and procurement of each countermeasure identified under subsection (a)(4)(A). CommentsClose CommentsPermalink





‘(g) Definitions- In this section: CommentsClose CommentsPermalink





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





‘(2) The term ‘NIH’ means the National Institutes of Health. CommentsClose CommentsPermalink





‘(3) The term ‘Project Bioshield’ means the Federal medical countermeasure procurement program established byPublic Law 108-276.’. CommentsClose CommentsPermalink

TITLE IV--FOREIGN RELATIONS MATTERS CommentsClose CommentsPermalink

SEC. 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-- CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





(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 CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink

SEC. 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-- CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





(4) promote the development and adoption of international guidance for the safety and security of high-risk pathogens and toxins; and CommentsClose CommentsPermalink





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

SEC. 403. INTERAGENCY TASK FORCE ON BEST PRACTICES FOR GLOBAL BIOPREPAREDNESS.

(a) Sense of Congress- It is the sense of Congress that preparedness for a chemical, biological, radiological, or nuclear incident must be undertaken not only 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. CommentsClose CommentsPermalink





(b) Establishment of Task Force- The Secretary of State shall convene and lead an interagency task force to examine-- CommentsClose CommentsPermalink





(1) the state of global biopreparedness for a major biological event; CommentsClose CommentsPermalink





(2) necessary components of a global biopreparedness architecture that would advance international health security, including considerations of-- CommentsClose CommentsPermalink





(A) risk assessments; CommentsClose CommentsPermalink





(B) prevention and deterrence; CommentsClose CommentsPermalink





(C) detection; CommentsClose CommentsPermalink





(D) regional stockpiling of medical countermeasures, including considerations of-- CommentsClose CommentsPermalink





(i) security of the stockpile; CommentsClose CommentsPermalink





(ii) delivery planning; and CommentsClose CommentsPermalink





(iii) legal dimensions of and obstacles to implementing such an architecture; CommentsClose CommentsPermalink





(E) attribution; CommentsClose CommentsPermalink





(F) response; CommentsClose CommentsPermalink





(G) other elements that should be a component of such an architecture; and CommentsClose CommentsPermalink





(H) obstacles to implementing such an architecture; CommentsClose CommentsPermalink





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





(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 CommentsClose CommentsPermalink





(5) the utility of working through existing international forums as a mechanism for distributing this information to the international community. CommentsClose CommentsPermalink





(c) Membership- Members of the task force shall include representatives from-- CommentsClose CommentsPermalink





(1) the Department of Homeland Security; CommentsClose CommentsPermalink





(2) the Department of Health and Human Services, including the Centers for Disease Control and Prevention; CommentsClose CommentsPermalink





(3) the Department of Agriculture; CommentsClose CommentsPermalink





(4) the Department of Defense; CommentsClose CommentsPermalink





(5) the Department of Justice; CommentsClose CommentsPermalink





(6) the Department of State; CommentsClose CommentsPermalink





(7) the United States Agency for International Development; CommentsClose CommentsPermalink





(8) the Director of National Intelligence; CommentsClose CommentsPermalink





(9) other Federal dDepartments and agencies, as determined appropriate by the Secretary; and CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink





(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. CommentsClose CommentsPermalink

SEC. 404. BIOLOGICAL AND TOXIN WEAPONS CONVENTION.

The Secretary of State shall-- CommentsClose CommentsPermalink





(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; CommentsClose CommentsPermalink





(2) promote universal membership in the Convention; CommentsClose CommentsPermalink





(3) develop an action plan for increasing international adherence to the Convention; and CommentsClose CommentsPermalink





(4) ensure that United States participation in Convention meetings is broadly inclusive of representatives of relevant Federal departments and agencies. CommentsClose CommentsPermalink