PUBLIC HEALTH SECURITY AND BIOTERRORISM
RESPONSE ACT OF 2001

TITLE I, National Preparedness for Bioterrorism and other Public Health Emergencies

This title authorizes $2.72 billion for national, state, and local efforts to be prepared for bioterrorism and other public health emergencies. It is divided as follows:

• $1.16 billion for emergency medical stockpiles, which includes $509 million for the smallpox vaccine, as requested by the Administration.

• $450 million for the Centers for Disease Control and Prevention (CDC), including:

-- $300 million for facility upgrades and expansion.

-- $150 million to upgrade and expand the national network of public health laboratories; develop national public health communications and disease surveillance systems.

• $1 billion for state and local preparedness, including:

-- $910 million for grants under already authorized programs to state, local, and other governmental entities to develop emergency plans and to implement them, including training and equipping of first responders and health care personnel and facilities.

-- $40 million for education of health care personnel who are in short supply.

• $25 million is reserved for research into anti-microbial-resistance programs.

• $90 million for other ongoing programs.

TITLE II, Enhancing Controls on Dangerous Biological Agents and Toxins

Title II is a slight revision of H.R. 3160, the "Bioterrorism Enforcement Act of 2001," which was passed by the Committee and approved unanimously by the House in a 419-0 vote on October 23, 2001. H.R. 3160 establishes a mandatory registration system and national database at CDC for select agents (such as anthrax) and civil and criminal penalties for persons who knowingly refuse to comply with such registration. Changes since passage include:

• Eliminating aliens who are not permanent residents in the United States from the list of restricted persons not allowed to work with select agents.

• Adding a law enforcement screening requirement for all persons working with select agents.

• Adding a savings clause to protect the Department of Agriculture’s existing registration system for transferors of select agents.

TITLE III – Protection of Food and Drug Supply

Authorization of Appropriations

Authorizes $100,000,000 for increased inspection 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.

Permissive Debarment of Food Importers

Importers who are convicted of a felony related to food importation or who repeatedly import food they knew or should have known was adulterated, are subject to debarment from importing food into the U.S.

Increased Inspection

Requires importers to notify the Food and Drug Administration (FDA) of food shipments not less than 24 hours and not more than 72 hours in advance of their arrival to enable FDA to conduct inspections at the ports of entry.

Prohibits importation of food unless sufficient prior notice has been given to the FDA. Without adequate prior notice, food may be imported if the Secretary determines that subsequent notice complies with the regulations. Failure to provide sufficient and timely prior notice will trigger increased scrutiny by the Secretary in his review.

Authorizes FDA to have imported food held at its port of entry for inspection (up to 24 hours), if it has information indicating a threat of serious adverse health consequences.

Administrative Detention Authority

Authorizes the FDA to detain food in a secure location (up to 30 days) if, after inspection, it has information indicating a threat of serious adverse health consequences. FDA must then notify the state in which the port of entry involved is located.

Notification to States

If FDA has 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 remedial powers to remove the suspect food from commerce.

Establishes grants to States in order to carry out remedial actions conducted in association with 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."

Record Keeping

Authorizes the Secretary to promulgate regulations requiring industry record keeping (except farms and restaurants), and FDA may inspect such records if it has information indicating a threat of serious adverse health consequences.

Registration

Requires manufacturers, processors, packers, or holders of food for consumption in the United States (excluding farms) to register with the FDA. The Secretary may, by regulation, exempt types of retail establishments from this requirement.

Mandates annual registration of foreign manufacturers engaged in the import of drug and device products into the United States.

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 components containing any chemical substance or biological substance 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 indicating that the article presents a threat of serious adverse health consequences or death to humans or animals.

TITLE IV -- Drinking Water Security and Safety

Vulnerability Assessments

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.

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

$120 million dollars is authorized in FY 2002 and such sums as may be necessary thereafter.

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.

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.