Legislation and Regulation
LEGISLATION AND REGULATION
In the United States, public health programs are implemented through governmental agencies at both the state and federal levels. Federal agencies are created by Congress and are part of the executive branch of the government. Some state agencies are created by their state constitution, but most are created though state legislation. State agencies can be part of the governor's office, headed by independently elected officials, or supervised by independent boards that are appointed by the governor or the legislature, or are popularly elected.
A law establishing an agency is called "enabling legislation." Enabling legislation establishes the mission of an agency and defines its powers. It is the most important limitation on agency action. An agency has only the power it is given in its enabling legislation or by the state constitution. Agencies created by the legislature can have only the powers that the state and federal constitutions allow the legislature to delegate. The legislature can also modify the enabling legislation if it wants to change the agency's mission or powers.
Enabling legislation may be very specific as to the role of an agency and how the agency is to enforce the law, leaving the agency little discretion in its actions. More commonly, however, the legislature gives an agency a general mandate, such as "protect the public health," and directs the agency to decide the best way to do this. This allows the details to be developed by agency staff, and it makes it easier to respond to new threats and changing conditions because no new legislation is required. When the agency is charged with developing regulations, it must make them available to the public. This can be done through notice and comment rule making, which requires that proposed regulations be published for public comment, that the agency respond to the comments, and that the proposed regulation be revised and republished if necessary. The agency must also publish the information it relied upon to develop the proposed regulation, including whether it relied on private standards such as building codes or standards developed by other agencies. In some circumstances the agency may also have public hearings on proposed regulations. When the regulations are adopted, they are legally binding unless they exceed the agency's authority or conflict with other laws or the state or federal constitution. In emergencies, rules can be published and put into affect without a prior comment period, as long as they are subject to later revision. Thus the agriculture department might publish an emergency rule to block the import of BSE infected beef.
In addition to formal regulations, agencies publish documents that explain how the agency interprets the law, and how to comply with it. These guidance documents do not have the force of law, in that they are not binding on the courts. They are useful because they can provide a plain language explanation of formal regulations and enabling legislation, and thus assist the public with compliance. An agency can also provide guidance by publishing records of enforcement actions. While the agency is not bound to follow past precedent in all cases, it does provide useful information for regulated entities.
When the courts review a law passed by the legislature, they are obliged to uphold it unless there are constitutional problems with it. When courts review agency regulations, they determine whether the agency is constitutional, whether it is within the powers delegated to the agency, whether the delegation is constitutional, and whether the agency followed the correct procedures for promulgating or enforcing the regulation. If the regulation passes this test, the court will defer to the agency's expertise on nonlegal matters. In a classic public health case, Jacobson v. Massachusetts (1905), the United States Supreme Court found that a regulation requiring smallpox vaccination could not be over-turned just because some scientists disagreed with it. The Court established the standard that it is the agency's role to choose from available regulatory alternatives, and in the process to balance the needs of the individual and those of the state. The courts will not second-guess such decisions unless they are outside the agency's legal authority, or if the agency acted in an arbitrary and capricious manner in promulgating or enforcing the regulation. Without this deference, public health regulation could often be stalled in the courts. In a modern example, the courts have allowed health departments to require the named reporting of HIV (human immunodeficiency virus) infection, despite opposition by some public health officials.
Edward P. Richards
(see also: Landmark Public Health Laws and Court Decisions; Licensing; Police Powers; Public Health and the Law; Regulatory Authority )
Grad, F. (1990). The Public Health Law Manual. APHA Press.
Richards, E. P., and Rathbun, K. C. (1998). "Public Health Law." In Maxcy-Rosenau-Last Public Health and Preventive Medicine, ed. R. B. Wallace. Stamford, CT: Appleton and Lange.
—— (1999). "The Role of the Police Power in 21st Century Public Health." Journal of Sexually Transmitted Diseases 26(6): 350–357.
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