PUBLIC HEALTH SECURITY AND BIOTERRORISM
PREPAREDNESS AND RESPONSE ACT OF 2002

TITLE I -- NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES

Grant Programs

The purpose of the grants programs is to develop and implement a coordinated strategy, building upon core public health capabilities to plan, prepare for, prevent, and respond to bioterrorism and other public health emergencies.

Preparedness Plan

A national preparedness plan is to be developed. This will contain preparedness goals designed to provide effective assistance to state and local governments in the event of bioterrorism or other public health emergency. This includes resources to ensure that state and local governments have appropriate capacity to detect and respond effectively to emergencies. The plan also includes coordination components, the development and maintenance of medical countermeasures, and enhancing readiness of hospitals and other health care facilities.

Assistant Secretary for Public Health Emergency Preparedness; Coordination for Preparedness and Response to Bioterrorism and Other Public Health Emergencies

The agreement creates a new Assistant Secretary for Public Health Emergency Preparedness. This person is responsible for coordinating bioterrorism efforts between the Department of Health and Human Services (HHS) and other federal agencies as well as between HHS and state and local entities with responsibility for emergency preparedness. The Assistant Secretary is also charged with evaluating the progress of state and local entities in meeting benchmarks and other outcome measures in the national preparedness plan.

Centers for Disease Control and Prevention

Because the CDC has an essential role in defending against bioterrorism and other public health threats, the agreement authorizes substantial resources to upgrade facilities, train personnel, improve communications systems, bolster public health surveillance and reporting activities, and improve the security of laboratory facilities.

Education of Health Care Personnel

The agreement authorizes programs to train health care professionals and other first responders to identify potential bioweapons and other agents that may create a public health emergency, and to care for victims of such emergencies.

Grants Regarding Training and Education of Certain Health Professionals

The agreement authorizes recruitment and training programs where there is a shortage of health care workers that the Secretary determines should be alleviated in order to prepare for or respond effectively to bioterrorism and other public health emergencies.

Advance Registration; Certain Waivers

The agreement authorizes the establishment of a system for the advance registration of health professionals for the purpose of verifying credentials, licenses, accreditations, and hospital privileges, improving the ability of certain first responders to act quickly if needed. The agreement also provides for limited waivers from Medicare, Medicaid, and SCHIP in emergency circumstances.

Working Group

The working group will consist of representatives of virtually all federal agencies, as well as state, local, and private sector entities with expertise or responsibilities that bear upon the federal bioterrorism planning, preparation, prevention, and response effort. The working group will make recommendations on a wide variety of issues.

Antimicrobial Resistance

The agreement creates a focus and enhanced effort to meet the special challenges of resistant forms of pathogens.

Strategic National Stockpile

The agreement directs the Secretary to maintain stockpiles of drugs, vaccines and other biological products, medical devices, and other supplies determined by the Secretary to be appropriate and practicable, taking into account other sources, to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency. The particular health security needs of children and other vulnerable populations is to be taken into account.

Accelerated Research and Development and Approval of Priority Countermeasures, Animal Studies, and Evaluation of New and Emerging Technologies

The agreement addresses a variety of research initiatives relevant to dealing with bioterrorism and other public health threats and confers "fast track" status on priority counter measures for purposes of product review and approval. The agreement also makes clear that FDA can use animal studies for evaluating certain countermeasures where human studies are not appropriate. The agreement also directs the Secretary to evaluate new and emerging technologies that are designed to improve or enhance public health surveillance activities relating to bioterrorist attack or other public health emergency.

Potassium Iodide

The national stockpile shall include potassium iodide tablets in quantities sufficient to provide adequate protection for the population within 20 miles of a nuclear power plant. The respective roles of federal, state, and local agencies are addressed.

Improving State and Local Preparedness

The agreement authorizes grants to states, localities, and hospitals. One grant program will provide funds to eligible entities including states, political subdivisions of states or consortia of two or more such subdivisions. Another grant program will provide resources to eligible entities consisting of hospitals, clinics, health centers, or primary care facilities and various combinations of states or political subdivisions of states. The conference agreement is a compromise between distinctly different approaches in the Senate and House bills, plus a need to coordinate with the Administration’s existing grant programs so that resources that will flow to states and first responders in FY 2002 and FY 2003 are not delayed, diminished, or denied.

FY 2002 Centers for Disease Control and Prevention (CDC) state formula grants and HRSA hospital grants will total approximately $1.1 billion. The FY 2003 request is approximately $1.6 billion. The amounts authorized in subsequent years are "such sums" as may be needed.

Department of Health and Human Services

Title II establishes a mandatory registration system and national database at the Department of Health and Human Services for persons in possession of select agents and toxins (such as anthrax), requires that HHS establish safeguard and security measures for the possession, transfer and use of those agents, and sets up a process by which to screen individuals working with these agents for criminal and terrorist activities. This closes a large gap in the existing law, which regulates only the transfer of select agents and cannot be used to determine who possesses select agents or what their characteristics are. Persons possessing select agents must notify the Secretary if the agents are lost, stolen or released outside of the biocontainment area. An exemption to the Freedom of Information Act authorizes withholding information from the registration, inspection and notification documents that would reveal the identity of the select agents and their location Civil and criminal penalties are authorized for persons who knowingly refuse to register agents under their control and transfer agents to unregistered persons. The title also requires HHS to review its list of select agents every two years.

Exemptions to these regulations are provided for clinical and diagnostic laboratories which are only holding agents for diagnostic purposes as long as they notify the Secretary of the diagnosis and properly dispose of the agents. A second exemption covers products approved under the Food, Drug and Cosmetic Act, the Federal Insecticide, Fungicide and Rodenticide Act, and the Virus-Serum-Toxin Act. The Secretary also may exempt investigational products.

An aggressive schedule for implementing these provisions is mandated. Thirty days after the legislation is enacted, HHS is required to issue guidance to parties possessing select agents. Persons possessing the agents must notify HHS within 90 days. An interim final rule for implementation of the entire title is to be issued within 180 days.

Department of Agriculture

A significant change from the bills passed by both the House and Senate is the inclusion of a comparable regulatory and criminal structure for the Department of Agriculture (USDA), which also regulates those"overlap" select agents because they also affect animals. Currently, both departments are regulating the agents independently under their own laws. The bill requires HHS and USDA to enter into a memorandum of understanding that will provide for a single system of registration and screening of individuals working with select agents. The agencies may coordinate facility inspections and regulatory enforcement.

Title II also gives USDA the authority for the first time to establish a list of its own select agents and toxins, which affect only plants and animals. Under this section, USDA, which already controls the import of such agents, would be able to tightly control their possession, control and use in the United States. Civil and criminal penalties are also imposed for persons who knowingly refuse to register these agents under their control or transfer them to unregistered persons.

Authorization of Appropriations

Authorizes $100 million in fiscal year 2002, and such sums as may be necessary through 2006, to the Department of Health and Human Services (HHS) for increased inspections of food, improved information management systems, development of rapid detection inspection methods, a threat assessment for emerging food safety concerns, and corresponding reports to Congress. Authorizes $10 million in fiscal year 2002, and such sums as may be necessary through 2006, to HHS for grants to States for increased inspection activities and $19.5 million in fiscal year 2002, and such sums as may be necessary through 2006, to HHS for grants to States for improved surveillance and information sharing. Authorizes $750,000 to the President’s Council on Food Safety for fiscal year 2002, and such sums as may be necessary for each fiscal year thereafter, to develop a crisis communications and education strategy for bioterrorist threats to the food supply. Authorizes $180 million in fiscal year 2002, and such sums as may be necessary through 2006, to the Department of Agriculture (USDA) for biosecurity upgrades at specific USDA laboratories. Authorizes $235 million in fiscal year 2002, and such sums as may be necessary for each fiscal year thereafter, to the USDA for assorted programs.

Permissive Debarment of Food Importers

Importers convicted of a felony related to food importation or who are engaged in a pattern of importing adulterated food, are subject to debarment from importing food into the U.S. Food imported by a debarred person shall not be admitted into the U.S., unless a person (other than a debarred person) affirmatively establishes that the food is in compliance with the Act.

Prior Notice

Importers must provide prior notice directly to the Food and Drug Administration (FDA) of food shipments to the U.S. The FDA shall establish a period of time, not less than the minimum amount of time necessary for the FDA to "receive, review and appropriately respond" to such notice and not more than 5 days, in advance of a shipment’s arrival. (If no rule, the provision self-effectuates at the expiration of 18 months with an 8 hour minimum and a 5 day maximum.) This enables the FDA to prioritize its resources and conduct inspections at the ports. It also gives the FDA maximum flexibility while preserving its responsibility to effectively use this tool.

The provision prohibits the importation of food unless sufficient prior notice has been provided. Without adequate prior notice, food may only be imported if the Secretary determines that a subsequent notice complies with the requirements. The Secretary must use increased scrutiny in making this determination.

Temporary Hold

Requires the FDA to have imported food held at its port of entry for inspection (up to 24 hours), if it has credible evidence or information indicating a threat of serious adverse health consequences. The FDA must also notify the State in which the port of entry involved is located.

Administrative Detention Authority

Authorizes the FDA to detain food in a secure location (for 20 days, and up to 30 days if necessary) if, after inspection, it has credible evidence or information indicating it presents a threat of serious adverse health consequences. The FDA may use this authority unilaterally without court action or cooperation from the Department of Justice.

Notification to States (Defacto Recall Authority)

If the FDA has credible evidence or information indicating that imported food presents a threat of serious adverse health consequences, it must notify the States to which it believes the food may have been shipped and must request that such States use their remedial powers to remove the suspect food from commerce. (All but one State currently have recall authority). It also provides grants to States to assist them with carrying out the remedial actions contemplated by this provision.

Prohibition on Port Shopping

Prohibits port shopping and authorizes the FDA to require that imported food that has been refused entry into the United States be marked "Refused Entry into the United States." Importation of food that has been marked "Refused Entry" is a Prohibited Act under § 301. Furthermore, if food has been marked "Refused Entry" and the Secretary determines that it presents a threat of serious adverse health consequences, then that food is also Misbranded under § 403.

Record Keeping

Authorizes the Secretary to promulgate regulations requiring industry record keeping (except farms and restaurants), and the FDA may inspect such records if it has a "reasonable belief" that the food is adulterated and presents a threat of serious adverse health consequences.

Registration

Manufacturers, processors, packers, or holders of food for consumption in the United States must register with the FDA. The requirement to register does not apply to farms, restaurants, retail establishments or non-profit food establishments. The requirement to register for foreign facilities is limited to those foreign facilities that manufacture, process, pack or hold food that is shipped to the U.S. without further processing or packing.

Authority to Commission Other Federal Officials

The FDA, pursuant to a memorandum of understanding, may commission other federal officials to conduct examinations and investigations.

Surveillance of Zoonotic Diseases

Requires multi-agency coordination to track the occurrence of zoonotic diseases.

Provisions Affecting the Department of Agriculture

In addition to upgrading biosecurity at specific Department of Agriculture (USDA) Level 3 Laboratories, the bill also includes provisions granting the Secretary of Agriculture discretionary authority, in the context of bioterrorism, to expand the Animal and Plant Health Inspection Service (APHIS), expand the Food Safety Inspection Service (FSIS), expand the research activities of the USDA, and award grants to create and review biosecurity standards and practices.

Animal Enterprise Terrorism

Increases the penalty for acts of terrorism committed against Animal Enterprises. This provision is being included at the request of the House/Senate Judiciary Committee Chairs and Ranking Members.

Import for Re-export

Mandates a chain of possession identification and a customs bond for those firms that seek to import components of products subject to FDA regulation for further processing and export. Requires certificates of analysis for most chemical or biological substances intended for export. Clarifies that the provisions permitting import-for-export do not apply to articles in which the Secretary of Health and Human Services determines that there is credible evidence or information that the articles may not be exported or destroyed.

TITLE IV -- DRINKING WATER SECURITY AND SAFETY

Vulnerability Assessments and Emergency Response Plans

Requires each community water system serving more than 3,300 persons to conduct a vulnerability assessment and prepare or update emergency response plans within 6 months after a vulnerability assessment is conducted.

A copy of the vulnerability assessment will be submitted to the Environmental Protection Agency, but the assessments are exempt from disclosure under FOIA and will be maintained in a secure location with restricted access. The emergency response plans will not be submitted to the EPA, but will be maintained by the community water system for 5 years.

Financial assistance is authorized for vulnerability assessments, emergency response plans, basic security enhancements of critical importance, to address significant threats to public health, and for immediate and urgent security needs

$160 million dollars is authorized in FY 2002 and such sums as may be necessary thereafter for FY 2003 through FY 2005.

Methods To Detect and Prevent Introduction of Biological and Chemical Contaminants

EPA is required to review methods to prevent, detect, and respond to the intentional introduction of chemical, biological, or radiological contaminants into community water systems and review means to prevent supply disruption.

$15 million is authorized in FY 2002 and such sums as may be necessary thereafter for FY 2003 through FY 2005.

Criminal Penalties

Criminal penalties for tampering and threatening to tamper with water systems are significantly increased.

Technical Assistance and Funding for Emergencies

$35 million is authorized each year under Section 1442 of current law for EPA to provide technical assistance and make grants to states and publicly-owned water systems in an emergency situation.

EPA Emergency Powers

EPA emergency powers in Section 1431 are increased where an imminent and substantial endangerment to the health of persons may be presented from a threatened or potential terrorist attack or other intentional act designed to disrupt the provision of safe drinking water.

Increase in user fees and adjustment factors

User fees to be collected under the act have been increased substantially. The FDA will receive authority to collect fees totaling $223 million in FY 2003 escalating to $259 million in FY 2007 plus adjustments. Adjustment factors now include a revised inflation adjuster and a new workload adjuster both designed to provide the FDA with funds sufficient to meet the goals set out in the Agreement between the Agency and the industry. Furthermore the timing of both fee collections and adjustments has been modified to smooth the flow of funds to FDA from these fees.

Accountability

This section mandates for a more open process for involving other stakeholders and Congress early in the development of the goals and plans to meet the goals for the anticipated reauthorization of the Act for fiscal years beyond 2007. It also provides that the Secretary’s recommendations for any new agreement be published in the Federal Register, supplied to the Committees of Congress, and a public hearing and docket established to receive comments. Performance and Fiscal Reports to Congress continue to be required annually.

Post Marketing Studies

The Secretary is required to publish on the FDA website the status of all post marketing studies mandated or agreed to in connection with the approval of a new drug or supplement. If completion of such studies are delayed or if the study is terminated and the reason is not satisfactory to the Secretary, that fact must be noted on the website. This section further provides that if the post marketing study is mandatory and is not completed within the prescribed time or is terminated for reasons not satisfactory to the Secretary, the Secretary is authorized to require the sponsor to notify all prescribers and inform them of the questions of clinical benefit and, where appropriate, the safety issues which remain unresolved because of the failure to complete the study.

Office of Drug Safety

The Secretary is required to reserve an additional $5 million in FY 2003 and $10 million in FY 2004 above existing levels and an inflation adjustment for each year thereafter for the Office of Drug Safety. This is in addition to the $76 million over 5 years of the user fees that must be dedicated to risk management activities.

Drug Marketing Review

The Division of Drug Marketing, Advertising, and Communications at FDA is authorized to receive additional sums of $2.5 million in FY 2003 rising to an additional $7.5 million FY 2007.

Generic Drugs

The Office of Generic Drugs at FDA is authorized to receive additional appropriations of $3 million in FY 2003 rising to an additional $15 million in FY 2007.

Subtitle C – Additional Provisions

Title V also includes two technical provisions involving Medicare and spectrum policy.