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Statement of Need: The quarantine of persons believed to be infected with communicable diseases is a long-term prevention measure that has been used effectively to contain the spread of disease. As diseases evolve due to natural occurrences or man-made events, it is important to ensure that prevention procedures reflect new threats and uniform ways to contain them. Recent experiences with emerging infectious diseases such as West Nile Virus, SARS, and monkeypox have illustrated the rapidity with which disease may spread throughout the world, and the impact communicable diseases, when left unchecked, may have on the global economy. Stopping an outbreak — whether it is naturally occurring or intentionally caused — requires the use of the most rapid and effective public health tools available. One of those tools is quarantine — restricting the movement of persons exposed to infection to prevent them from infecting others, including family members, friends, and neighbors. Quarantine of exposed persons may be the best initial way to prevent the uncontrolled spread of highly dangerous biologic agents — especially when combined with other health strategies such as vaccination, prophylactic drug treatment, patient isolation, and other appropriate infection control measures.

Summary of the Legal Basis: These regulations would be proposed under the authority of 25 U.S.C. 198, 231, 2001; 42 U.S.C. 243, 264-271. In addition, Section 361(b) of the Public Health Service Act (42 U.S.C. 264(b)) authorizes the “apprehension, detention, or conditional release” of persons to prevent the introduction, transmission, and spread of specified communicable diseases from foreign countries into the United States and from one State or possession into another. Among other public health powers, the lawful ability to inspect property, to medically examine and monitor persons, and to detain or quarantine exists in current regulations. Acknowledging the critical importance of protecting the public’s health, long-standing court decisions uphold the ability of Congress and State legislatures to enact quarantine and other public health laws, and to have them executed by public health officials.

Alternatives: The proposed regulations are necessary to ensure that HHS has the tools it needs to respond to public health emergencies and disease threats. Any less stringent alternatives would prevent the Department from the most effective possible pursuit of this objective. From a due process perspective, the proposed regulation would clarify administrative procedures, and would detail the elements generally recognized as essential to comport with constitutional requirements. Those elements include: Reasonable and adequate notice; opportunity to be heard in a reasonable time and manner; access to legal counsel; review by an impartial decision-maker; and written articulation of the rationale underlying the decision.

Anticipated Costs and Benefits: The primary cost impact of the proposed rule would be the collection and maintenance of crew and passenger manifest data. by air and water carriers that are likely to modify computer systems and collect passenger information to come into compliance. The benefits of the rule would be measured in terms of the number of deaths and illnesses prevented by rapid intervention. When the costs and benefits of the rule are considered over a 20-year period benefits clearly outweigh costs.

Risks: Failure to move forward with this rulemaking would hinder the Nation’s ability to use the most rapid and effective public health tools available when responding to public health emergencies and disease threats.