Washington, DC - October 21, 2003
Recent Homeland Security and Bioterrorism Developments
- Bills in the U.S. Senate and House of Representatives Related to Homeland Security and Bioterrorism
Several pending key legislative initiatives relate to bioterrorism and other homeland security concerns. These include the following:
- Project BioShield, originally introduced as The Biodefense Improvement and Treatment for America Act (Project BioShield Act of 2003), S.15, 108th Cong. 1st Sess. (March 11, 2003). This proposal, which was originally introduced by Sen. Judd Gregg (R-NH) after the President announced the BioShield Project in his State of the Union Address in January of 2003, would amend the Public Health Service Act to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack. The proposal is wide-reaching, and includes the following measures, among others: it grants the Secretary of the U.S. Department of Health and Human Services (“HHS”) extensive authority to take action to support the development and availability of biomedical countermeasures (defined in the Act as drugs, biological products, or devises used to treat, identify or prevent harm from a biological, chemical or nuclear agent that may cause a public health emergency affecting national security, or a condition arising from the administration of such a drug, biological product, or devise); it directs the Secretary of the U.S. Department of Homeland Security (“DHS”) to assess threats of use of chemical, biological and nuclear agents against the United States population on an ongoing basis, determine the threats to which countermeasures are necessary to protect the public health, and submit proposals (in conjunction with the HHS Secretary) to call for needed countermeasures; and it amends the Federal Food, Drug and Cosmetic Act to allow the HHS Secretary to declare a national emergency under certain specified conditions and authorize the release of a drug or device intended solely for use in an emergency. Most importantly, the bill would allow the government to fund and create a market for biomedical countermeasure products.
Senator Gregg’s proposal was referred to the Senate Committee on Health, Education, Labor and Pensions. The bill was passed unanimously by this Committee and was placed on the Senate Legislative Calendar on March 25, 2003.
On May 22, 2003, the House Committee on Government Reform marked up the House version of the Project BioShield Act, H.R.2122. Markup in the House Select Committee on Homeland Security took place on June 26, 2003. After markup, the bill was passed unanimously by the Committee. On July 8, 2003, the bill was reported by the Committee.
The House passed H.R.2122 on July 16, 2003, with funding of $5.6 billion over ten years and up to $890 million for Fiscal Year 2004. When the debate moved to the Senate, the progress of Project BioShield temporarily stalled in the Senate due to debate over funding concerns. Sen. Robert Byrd (D-WV) expressed a concern with the funding for the Bill, apparently articulating the concerns of the pharmaceutical industry. The pharmaceutical industry has expressed concern about involvement with bioterror response efforts under Project Bioshield if the funding for the Project is discretionary.
On September 3, 2003, Sen. Byrd and Sen. Gregg reached an agreement over funding to allow an updated Senate version of the bill, S.1504, to progress. The agreement makes funding discretionary, similar to the House version of the bill. S.1504 is estimated to cost $8.1 billion over the next ten years. The Homeland Security Appropriations bill for Fiscal Year 2004 contains $890 million allocated for Project BioShield. S.1504 is currently on the Senate Legislative Calendar awaiting action.
- Regional Comprehensive Emergency Preparedness, Response, and Coordination Act of 2003, H.R.3274, 108th Cong. 1st Session (October 8, 2003). This bill, introduced by Rep. Jack Kingston (R-GA), is intended to “encourage and facilitate the development and implementation of regional emergency and disaster preparedness, response and recovery coordination plans among Federal, State and local governments and the private sector within the region and to facilitate preparedness and mitigation efforts.” The bill would mandate the development of regional disaster assessment and response plans, and would allocate funds to aid in the development and execution of these plans.
This bill was referred to the Committee on Transportation and Infrastructure as well as the Committees on Energy and Commerce and the Judiciary on October 8, 2003. The bill was referred to each Committee for consideration of such provisions as fall within the jurisdiction of the Committee concerned.
- The Smallpox Vaccine Compensation and Safety Act of 2003, H.R.865, 108th Cong., 1st Sess. (February 13, 2003). This bill, introduced by Rep. Henry Waxman (D-CA), would amend the Public Health Service Act to direct the Secretary of HHS to allocate grants to State and local governments for uses related to certain countermeasures against smallpox, including the administration of the smallpox vaccine. States that receive grants will be required to establish education programs concerning smallpox countermeasures and to offer screening and testing for conditions that increase health risks associated with countermeasures.
The bill has been assigned to several House subcommittees, including the Subcommittee on Health, the Subcommittee on Employer-Employee Relations, and the Subcommittee on Workforce Protections.
- First Responders Funding Reform Act of 2003, H.R.2512, 108th Congress, 1st Session (June 18, 2003). This bill, introduced by Rep. John Sweeney (R-NY), amends the USA Patriot Act to require: (1) that each State be allocated in each fiscal year not less than .5 percent (currently, .75 percent) of the total amount appropriated for domestic preparedness grants; (2) that such grants to be awarded based on a quantitative risk assessment for threat, vulnerability, and consequences; and (3) that the Office for State and Local Domestic Preparedness Support of the Office of Justice Programs submit that assessment to Congress by March 1 of each year.
The bill was referred to the House Committee on the Judiciary, and later to the House Subcommittee on Crime, Terrorism and Homeland Security.
- Global Pathogen Surveillance Act of 2003, S.871, 108th Cong., 1st Sess. (April 10, 2003). This bill, introduced by Sen. Joe Biden (D-DE), is designed to increase the capability and cooperation of the international community, including the World Health Organization, to detect, identify, and contain infectious disease outbreaks through enhanced pathogen surveillance and appropriate data sharing. The bill is also intended to assist developing countries in efforts to train health professionals in advanced syndrome surveillance systems and to purchase appropriate public health laboratory and communications equipment and information technology. In addition, the bill includes a number of measures designed to increase the availability of U.S. expertise to the international community when possible.
The bill was referred to the Senate Committee on Foreign Relations.
A House of Representatives version of the Global Pathogen Surveillance Act was introduced by Rep. Mark Kirk (R-IL) on June 4, 2003. The House version does not appear to differ in any way from the Senate version. The House bill was referred to the House Committee on International Relations.
- The Chemical Security Act of 2003, S.157, 108th Cong. 1st Sess. (Jan. 14, 2003). The version of the Chemical Security Act introduced in January of 2003 by Sen. Jon Corzine (D-NJ) would establish certain requirements for owners and operators of “stationary sources” (as the term is used in the Clean Air Act) to identify, prevent and minimize the consequences of intentional releases of designated substances. Also, certain “high-priority plants” would be identified by DHS in conjunction with the U.S. Environmental Protection Agency (“EPA”). The agencies would then develop regulations for these high-priority chemical plants, including requirements that the plans conduct vulnerability assessments and implement plans that include security improvements and safer technologies.
The bill has been assigned to the Senate Committee on Environment and Public Works.
An alternate approach to chemical security legislation, the Chemical Facilities Security Act of 2003, S. 994, 108th Cong. 1st Sess. (May 5, 2003), was recently introduced by Sen. Jim Inhofe (R-OK) and referred to Committee. This version would require companies to perform self-assessments of security vulnerabilities, but would not require the hazard reductions contemplated by the alternate version of the Act described above. This bill has also been assigned to the Senate Committee on Environment and Public Works. Mark-up of the Inhofe bill had been scheduled to begin May 15, 2003, but it now appears that the Committee has delayed mark-up in order to continue negotiations on the language of the bill.
- The National Resilience Development Act of 2003, H.R.2370, 108th Cong. 1st Sess. (June 5, 2003). This bill, which was introduced by Rep. Patrick Kennedy (D-RI), would create an interagency task force on “National Resilience.” The goal of this task force would be to “coordinate the efforts of different government agencies in their various efforts to increase psychological resilience and mitigate distress reactions and maladaptive behaviors of the American public as they relate to terrorism.”
This bill has been referred to the House Committee on Energy and Commerce, as well as the House Judiciary Committee and the House Committee on Transportation and Infrastructure. On June 25, 2003, this bill was referred to the House Subcommittee on Crime, Terrorism, and Homeland Security.
- The Biological, Chemical, and Radiological Weapons Countermeasure Research Act, S.666, 108th Cong. 1st Sess. (March 19, 2003). This bill, introduced by Sen. Joseph Lieberman (D-CT), would authorize the Director of the National Institutes of Health (“NIH”) to award “partnership challenge grants” to promote joint ventures between the government, grantees, and the for-profit biotechnology, pharmaceutical, and medical device industries for the development of biological, chemical, radiological and nuclear countermeasures and research tools. The bill would authorize $200 million for these grants for each of the fiscal years 2004 through 2008.
This bill has been referred to the Senate Committee on Finance.
Other Recent Newsworthy Developments at the Department of Homeland Security
- On October 10, 2003, DHS Secretary Tom Ridge announced the approval of the Initial National Response Plan (“INRP”). According to DHS, the INRP, dated September 30, 2003, “strengthens America's emergency response process by harmonizing existing Federal response plan activities with incident management leadership responsibilities assigned by President Bush to Secretary Ridge through Homeland Security Presidential Directive 5.” Among other things, the INRP would establish a permanent Homeland Security Operations Center, which would operate as the primary national-level hub for operations communications and information pertaining to domestic incident management. The INRP also would create an Interagency Incident Management Group (“IIMG”), comprised of representatives of Federal departments and agencies as well as non-governmental organizations. The IIMG would “facilitate national-level situation awareness, policy coordination, and incident coordination.”
The INRP also would provide the president with the authority to designate a Principal Federal Official (“PFO”) in the event of a domestic incident. The PFO would serve as a personal representative of DHS on a local level. The PFO would oversee and coordinate Federal incident activities, as well as working with local authorities to determine requirements and provide timely Federal assistance. In addition to the PFO, the INRP also calls for the establishment of Joint Field Offices to coordinate Federal, state and local activities at a local incident site.
The INRP would be supported by the National Incident Management System (NIMS), a national system under development that creates standardized incident management processes, protocols, and procedures.
DHS anticipates that a final National Response Plan will eventually replace the INRP.
- On September 25, 2003, DHS announced the first Homeland Security Advanced Research Projects Agency (“HSARPA”) Research Announcement solicitation. The HSARPA is the external research arm for DHS. The announcement seeks technological ideas for biological and chemical countermeasures. With respect to biological countermeasures, the announcement seeks technological ideas for “Bioagent Automous Network Detectors” that will be developed to continuously monitor outdoor urban and marine/shipboard areas for presence of bacteria, viruses or toxins. In addition, responses will be requested for Rapid Automated Biological Identification Systems which will monitor indoor buildings, such as shopping malls, stadiums and large ships, but with a quicker response time, providing occupants protection from the effects of an attack.
- Also on September 25, DHS announced that almost $74 million would be made available to 19 states and U.S. territories for and construction of and improvements to “Emergency Operations Centers.” The grants are intended to improve emergency preparedness and management by ensuring that the Centers have the capability to provide flexibility, sustainability, security, survivability, and interoperability in responding to emergencies. The grants were awarded after a competitive application process, and are being distributed by the Federal Emergency Management Agency (“FEMA”).
- On June 30, 2003, the Homeland Security Advisory Council (“HSAC”) met for the first time in Washington, D.C. The HSAC is a group of 18 individuals representing both the public and private sectors that will provide advice and recommendations to the DHS Secretary on homeland security-related issues. Joseph P. Grano, Jr, the chairman and CEO of UBS Paine Webber and a veteran of the U.S. Special Forces, was selected to serve as Chair of the HSAC. Christopher J. Furlow was selected to service as Executive Director for the HSAC.
Developments at GAO and Other Regulatory Events
Prepared by Kelley Drye & Warren LLP for USA Secure.
- On October 15, 2003, the U.S. General Accounting Office (“GAO”) published a report reviewing the public health response to the anthrax incidents of late 2001. The report reviews the response efforts in an effort to determine how the federal response to similar incidents in the future might be improved. The report has been made available in its entirety at the USA Secure 10/21/03 meeting. It can also be found at
www.gao.gov/cgi-bin/getrpt?GAO-04-152. The report concludes that the resources of CDC were strained by the incident, but that CDC has since taken steps to improve its capacity to respond to a similar bioterror incident. The report also reviews preparedness at the state and local level, concluding that response efforts generally promoted a rapid and coordinated response, but that there were some communications issues, including difficulty providing clinicians with the needed guidance.
- Biowatch: During the Summer of 2002, the White House asked EPA’s Office of Air and Radiation (“OAR”) to assist with monitoring the atmosphere for biological agents. This project is entitled “Biowatch.” The goal of the project is to sample the air in major metropolitan areas daily for pathogens that terrorists might use. The system involves the installation of special paper filters on existing Environmental Protection Agency (EPA) air-quality monitoring stations. Each filter is to be removed on a daily basis and taken to a laboratory for analysis. The initial network was deployed and operational as of May 2003. $40 million dollars was earmarked for the program for Fiscal Year 2003. The program is managed by EPA and run by state and local agencies.
- On October 9, 2003, the U.S. Food and Drug Administration (“FDA”) announced a new interim final rule aimed at reducing the threat of a bioterror attack on the United States via the food supply. The new regulations were mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which authorized the FDA to protect the nation’s food supply against actual or threatened terrorist acts.
The rules, published in the Federal Register on October 10, 2003 as interim final rules, consist of two new regulations. The first regulation required food importers to provide the FDA with advance notice of food shipments. Once this regulation is in place, FDA will know in advance when specific food shipments will be arriving at U.S. ports of entry, and what the shipments will contain. This will allow FDA to more effectively target inspections and ensure the safety of imported foods. This regulation applies to all shipments imported or offered for import on or after December 12, 2003.
The second regulation requires domestic and foreign food facilities that manufacture, process, pack or hold food for consumption in the United States to register with the FDA by December 12, 2003. This will allow FDA to maintain a complete roster of foreign and domestic food facilities, and therefore quickly identify and located affected food processors and other establishments in the event of a deliberate or accidental contamination incident.
- The Bush administration has proposed a budget of $3.6 billion for bioterrorism preparedness for HHS. This includes $1.1 billion allocated to Centers for Disease Control (“CDC”), with $940 million designated for allocation to the states to improve their preparedness programs, $158 million to improve CDC’s internal preparedness, and $18 million for anthrax research. It also includes $518 million for a hospital bioterrorism preparedness program. There is also a budget of $1.6 billion for the NIH to conduct biodefense research.
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