Bioterrorism, Public Health and the Law 
Law 801: Health Care Law Seminar
Professor Vernellia R. Randall

The Evolution of Public Health Regulation

 

Syllabus
Resources
Lesson Schedule
00: Intro to the Course
01: Intro to the Problem
02: Public Health System
03: Real Threat?
04: Public Health Law
05: Disease-Reporting
06: Quarantine
07: Model Act
08: Military Presence
09: Health Law Revisited

 

Eleanor D. Kinney

Excerpted from: Eleanor D. Kinney, Administrative Law and the Public's Health

The promotion and protection of public health is one of the oldest functions of government -- and certainly one of its earliest regulatory functions. Historically, even early governments, which existed primarily to promote the acquisition of wealth and territory by monarchs and their families, recognized some obligation to protect the health and safety of their subjects.

  Early public health regulation was rudimentary, as there was no clear understanding of the causes of disease or its modes of transmission. From the late Middle Ages, there was recognition of a relationship between filth and disease and some awareness of the vectors of many infectious diseases through observation. Thus, many jurisdictions had local ordinances targeted at "nuisances" and other sources of filth. Quarantine and isolation of the sick during epidemics -- the archetypal public health regulation -- have been used since the dawn of history. However, a lack of understanding of the germ theory of disease obscured the connection between communal sanitation and the prevention of infectious disease.

  The impetus for modern public health regulation was the sanitary revolution of the nineteenth century. During this period, scientific discoveries established the link between microorganisms and infectious disease, leading to a greater understanding of the vectors of infectious disease. Soon thereafter, societies concluded that they could prevent the spread of infectious disease through governmental action. Modern public health regulation was born.

  The leaders of the nineteenth century sanitary revolution appreciated that governmental authority was necessary to implement the strong and often coercive strategies required to clean up living conditions and prevent the spread of disease. In Europe and the United States, the industrial revolution, with its rapid urbanization and environmental degradation, wrought great hardship for many workers with increased poverty and disease. Also, technological developments of the industrial revolution permitted great movements of people across oceans and continents in search of treasure and freedom. These dislocations triggered greater public health regulation. Specifically, in the United States, the large cities on the East Coast, which were on the front lines in terms of sea trade and processing new immigrants, were the catalyst for governmental responses to public health concerns.

  Not surprisingly, in the United States, the early public health advocates focused on the local public agency as the model for executing public health responsibilities. The first local health board was organized in Baltimore, Maryland, in 1793, with other cities on the East Coast following shortly thereafter. By the early nineteenth century, local boards were established throughout the nation. As infectious diseases and their vectors do not appreciate political boundaries, states soon established state-level public health agencies throughout the later half of the nineteenth century. To this day, states continue to exercise primary responsibility for the regulation of the health professions.

  For the same reasons that the states established health departments, the federal government also engaged in public health regulation. The federal effort in public health like-wise was a response to the management of disease brought by seamen and immigrants to East Coast cities. Public health was an important concern to the framers of the U.S. Constitution, who envisioned protection and promotion of public health among the federal government's responsibilities. In 1798, Congress established hospitals under the Department of the Treasury to care for sick and disabled seamen in American ports. This statute also established a national board of health appointed by the president. This national board of health was never strong and languished in future years due to a lack of appropriations to fund its operation.

  The evolution of federal public health regulation proceeded in three stages. First, over the nineteenth century, there were responses to specific public health threats not adequately addressed at either the local or state level, such as the spread of infectious disease from seamen and immigrants. The most important development in this regard was the evolution of the Marine Hospital Service into the Public Health Service. This evolution began in 1870 when the Marine Hospital Service was reorganized as a national hospital system with centralized administration under a medical officer, the supervising surgeon. The leadership of the service selected a military model, with a commissioned officer corps for its organization, out of concern for the corruption and patronage that characterized the federal civil service generally. The Marine Hospital Service became the Public Health Service in 1912.

  Another important mid-nineteenth century development in federal public health regulation was the establishment of rudimentary food and drug safety regulation within the federal Department of Agriculture. Following subsequent enactment of the Food, Drug and Cosmetic Act in 1906, this agency ultimately became the Food and Drug Administration (FDA).

  The second stage in the evolution of federal public health regulation began with the establishment of the modern regulatory and welfare states as part of President Franklin Roosevelt's New Deal. During the New Deal, Congress established the FDA to execute the regulatory mandates of a new and improved Federal Food, Drug and Cosmetic Act of 1938. Of note, this statute required demonstration of the safety of new drugs -- an essentially scientific determination.

  The public health advances of the New Deal years were chiefly the creation and expansion of the welfare state. In the Social Security Act of 1935, Congress established social insurance programs for the aged and cash assistance programs for the aged, blind, and disabled as well as poor dependent children. These programs helped improve the public's health by assuring income security for groups at greater risk for poverty and disease. In 1965, this expansion of the welfare state continued with enactment of the Medicare and Medicaid programs for the aged as well as some disabled and some poor. By making health-care services available to vulnerable groups, these two programs dramatically raised the health status of vulnerable groups in the United States. The Medicare and Medicaid programs also greatly expanded the role of the federal government in addressing problems in the health-care sector.

  This second stage of public health regulation also witnessed the consolidation of the modern federal public health establishment in the mid- twentieth century. In 1930, the Ransdell Act established the National Institutes of Health from the Hygienic Laboratory and authorized the establishment of fellowships for biological and biomedical research. After World War II, the National Institutes of Health evolved into the current well-funded engine for biomedical research and training throughout the United States. The Centers for Disease Control (CDC), which was formed out of the Office of Malaria Control in War Areas in Atlanta, Georgia, became part of the Public Health Service with expanded public health responsibilities. In 1953, the federal public health and social welfare functions were consolidated into one cabinet-level department, the Department of Health, Education and Welfare. This department housed virtually all of the federal agencies with public health responsibilities (including the Medicare and Medicaid programs) that had evolved since the Civil War. In 1979, a new Department of Education was formed and the federal health and social services programs were consolidated into the Department of Health and Human Services (DHHS).

  The third stage of federal public health regulation in the 1960s and 1970s was the establishment of new regulatory programs to reduce risks to safety and health in the environment, workplace, and other settings. During this period, Congress enacted extensive environmental legislation to clean up the environment and maintain environmental quality. Perhaps the most important federal environmental legislation was the 1969 National Environmental Policy Act, which established a national policy for the environment that would guide federal environmental regulation. In 1970, the Nixon Administration consolidated existing and new federal environmental programs into the new and independent Environmental Protection Agency.

  Another major regulatory effort of this third stage of public health regulation was workplace health and safety. In the 1970s, Congress enacted the Occupational Safety and Health Act, which established a new regulatory program to promote health and safety in the workplace. The statute established the Occupational Safety and Health Administration (OSHA) within the Labor Department to set and enforce workplace safety and health standards; the National Institute for Occupational Safety and Health within DHHS to conduct research on occupational safety and health; and the Occupational Safety and Health Review Commission as an independent agency to adjudicate enforcement actions challenged by employers.

  Unlike earlier federal regulation that tended to be industry-specific and address market dislocations, this third stage of public health regulation reduced risks to health and safety across all industries. Consequently, this new generation of regulation generated great controversy and fueled conservative criticism of government regulation as well as the movement for deregulation that exists to this day. Critique of this new regulatory movement was a major position of the conservative Reagan Administration, which sought its reform. The political and economic ideology of the ReaganAdministration fundamentally questioned the appropriateness of government regulation to reduce risks to health and safety in the environment, the workplace, and other sectors.

  One important development from this controversy was the demand for a better assessment of the costs of regulation and a balancing of these costs with the benefits to be derived. More specifically, in 1980, President Reagan issued an Executive Order mandating cost-benefit analysis in executive branch agencies along with presidential review of agency rules and regulatory planning. President George Bush continued this presidential oversight with the Council on Competitiveness. Liberals saw this cost-benefit analysis as a methodology to undermine laudable liberal regulatory goals and to advance a more conservative agenda. Cost-benefit analysis, however, has since become more institutionalized, as evidenced by President Bill Clinton's Executive Order mandating the use of cost-benefit analysis in the promulgation of rules. It appears that the executive oversight of rules went far smoother under the Clinton Administration than the previous two Republican administrations, perhaps because of greater agreement between the agencies and the Office of Information and Regulatory Affairs with the Office of Management and Budget about regulatory goals.

  Nevertheless, since the middle of the twentieth century, great strides have been made, particularly in the developed world, in reducing risks to health and safety resulting from economic activity. Life expectancy in the more developed world is 75 years compared to 64 years in the less developed world -- a difference partially due to reductions in environmental and occupational risks to health and safety. In sum, health and safety regulation has become an essential and permanent component of the modern public health mission.

RELEVANT ADMINISTRATIVE LAW PRINCIPLES

  Administrative law defines the limits of the design and powers of public health agencies and delineates the procedures by which they exercise these powers. Administrative law and public health have had a long relationship, with much of administrative law developing in the public health context. State regulation of the professions has generated many important doctrines in state administrative law. For example, two leading U.S. Supreme Court decisions involving state professional licensure agencies establish procedural due process requirements for adjudicative hearings. The complexities of federal environmental regulation since the 1970s have also generated considerable development in federal American administrative law, particularly with respect to the law of policymaking and judicial review. The law of administrative inspections has also evolved almost entirely in the context of public health regulation.

  Administrative law addresses three main problems: (1) the design of administrative agencies and their leadership; (2) the powers vested in administrative agencies and the limits on their exercise; and (3) remedies to address unlawful actions by administrative agencies. Customarily, when the legislature addresses a public health problem, it enacts a statute that assigns the resolution or management of the problem to an existing or new administrative agency. The legislature is concerned about an agency design and leadership structure that best facilitates the agency's fulfillment of its statutorily assigned responsibilities.

  In the same vein, the legislature accords the agency the specific powers needed for the fulfillment of these responsibilities. Of primary importance in administrative law is whether the procedures are in place to ensure that the agency exercises these powers in a fair and democratic manner. The concept of procedure pertains to the form, manner, and order of how an agency makes the policies and decisions necessary to carry out its legal and regulatory business. Procedure has little to do with the substantive content of these policies, decisions, or other agency actions.

  Finally, the legislature may be concerned about safeguards for individuals who might be affected by agency action. The enabling legislation for the agency thus may specifically accord judicial review to individuals aggrieved by agency actions. Regardless, independent sources of law exist in the common law, and the applicable administrative procedure act also authorizes judicial review of agency actions, with a view toward invalidating illegal agency actions.

The structural design of administrative agencies

  The first issue with administrative agencies is how they are organized and their leadership constituted. The most important feature of agency design in administrative law theory is how the individual or governing body in which the power of the agency resides is selected. Each agency's enabling statute will specify how the responsible agency head or governing board is constituted and appointed as well as the terms of appointment. The terms of appointment are especially important as these terms determine the relative independence and the agency's power vis-?is the chief executive, other agencies of government, as well as other governmental branches such as the legislature and courts.

  In the United States, three models of administrative agencies with executive power predominate. The first is the independent department with an elected agency head. This model is found in the states, but not in the federal government. This model has not been widely used for state public health agencies, as generally the chief state health officer does not stand for statewide election. The second model is an executive department with appointment and complete power of removal by the chief executive. This model seems most consistent with the U.S. Constitution and is prevalent in both states and the federal government. At the federal level, DHHS exemplifies this model. Many states have adopted this model as well for their health departments or consolidated health and welfare agencies. The third model is the so-called "independent commission," in which the commissioners, the agency's governing authority, are appointed by the executive in staggered terms with conditions on their removal by the executive. This third model has been used in the federal government for economic regulation and also for some regulation addressing risks to health and safety.

  There is currently debate over the design of state health departments. Initially, nineteenth century state health departments were comprised of a board of physicians and other public members appointed by the governor. Their functions were more advisory and inquisitorial, leaving most executive functions to local boards of health. With the advent of the Medicaid program in the late 1960s and the need for states to assume major programmatic responsibility for the Medicaid program, many states departed from this model. Specifically, they combined their public health programs and the Medicaid program, along with other social programs, into a single super agency much like the federal DHHS. With a super agency, only the secretary of that agency sits in the governor's cabinet. This design leaves the public health function somewhat buried in the government bureaucracy, with reduced access to the governor and the legislature. It will be interesting to see if this agency structure at the federal level precludes the federal public health function from needed access to the president, Congress, and the scientific community in any future public health crises such as in fall 2001.

  It is noteworthy that the Institute of Medicine (IOM), in its 1988 recommendations for the reform of public health, called for the reinstitution of the state agency model, in which the commissioner of health has a cabinet- level position rather than a position subordinate to the secretary of a health and human services agency. Also, the IOM recommended that state public health agencies, in conjunction with local health departments, have primary responsibility for the public health function in the United States and that federal agencies serve a supporting role.

The powers of administrative agencies

  The second issue is the nature of the powers accorded public health agencies to execute their regulatory responsibilities. The central issue implicated is whether agencies have the authority to make the requisite policies and decisions to accomplish their statutory assignments. Specifically, can agencies make rules and policies that have the force of law? Can agencies adjudicate disputes with private parties that surface in enforcement and other agency activities? Also, what other powers do agencies have regarding the enforcement of the statute?

  The powers of the political entity sponsoring the administrative agency determine the type and scope of the agency's powers. American states, as former sovereign states, posses the police power to ensure public health, safety, and morals and the parens patriae power to protect children and incompetent adults. Under common law, the scope of police power in support of public health is extensive and long-standing.

  Indeed, courts have historically recognized the police power of states in the promotion of the public's health and, in particular, containment of disease in emergency situations. In its 1905 decision, Jacobson v. Massachusetts, the U.S. Supreme Court upheld the exercise of a state's police power to compel all its citizens to be vaccinated for smallpox. The court stated: "According to settled principles, the police power of a state must be held to embrace, at least, such reasonable regulations established directly by legislative enactment as will protect the public health and the public safety." The court also clarified that the exercise of police power to restrict liberty is appropriate only when necessary to prevent an avoidable harm and only without imposing harm. Further, if exercised, the public health measure must use reasonable means and be proportional to the public health problem addressed.

  The sources of power for public health regulation by the federal government are derivative powers set forth in the U.S. Constitution. Specifically, constitutional authority for most federal health activities comes chiefly from the constitutional requirement that Congress provide for the general welfare. Modern constitutional law and theory have accepted a wide range of authority as contemplated under the power to promote the public welfare as well as other delegated powers. Much of the federal regulation to reduce risks to health and safety in the environment, workplace, and other settings is based on these derivative powers of the federal government rather than state police powers.

  According to Professor Lawrence Gostin, public health statutes grant governments the following powers: (1) to identify cases of infection through compulsory serologic testing, screening of populations, or physical examinations; (2) to identify additional cases by investigating sexual or other contacts of known cases or carriers; (3) to require a class of persons to submit to a preventive vaccine or curative treatment; (4) to control personal behavior by isolating cases or carriers of disease or by quarantining exposed individuals; and (5) to control environmental health risks by closing or regulating specified establishments. These are truly extraordinary powers for they authorize government agencies not only to confiscate property, but, perhaps more importantly, to impose significant deprivations of liberty.

  Further, administrative agencies, depending on the provisions of an enabling statute, have three different types of powers: executive, legislative, and judicial. In prevailing administrative law theory, agencies need all three types of powers to carry out their statutory responsibilities, which generally involve implementing a regulatory program to solve a specific societal problem. Under administrative law theory, the legislature "delegates" legislative and also judicial powers to administrative agencies. With delegated legislative powers, agencies have the authority to promulgate rules that have the force of law. With delegated judicial powers, agencies have the authority to adjudicate disputes that arise in the enforcement of the enabling statute as well as to provide some appropriate remedies. As part of their executive, legislative, and judicial powers, administrative agencies have the authority to conduct investigations in conjunction with the implementation and enforcement of their statutory responsibilities.

  Historically, public health agencies have had broad rulemaking and adjudicative powers. The most notable of these rules and orders are those relating to the quarantines of individuals and/or populations. An early treatise on public health law describes these powers:

    The laws require local boards of health to take cognizance of the causes of injury or danger to the public health. Full power is given to them to make regulations and orders of general application, which shall be published and obeyed as laws; also to make special orders, to meet emergencies not provided for by regulations of general obligation, to be immediately enforced for the suppression of nuisances and of sources of contagious diseases or other great dangers to life and health.

  A crucial power of administrative agencies is the power to investigate. In general, agencies have powers to collect information from regulated parties through mandated reporting of specific information relevant to the agency's regulatory purposes, issuance of subpoenas for testimony and documents, and the inspection of regulated premises. These powers are so broad and so well- established that they are mentioned indirectly in the Constitution in a manner that suggests no doubt about their existence or appropriateness. Specifically, in Article I, ? 10, the Constitution prohibits states from imposing duties on imports or exports, "except what may be absolutely necessary for executing its inspection laws ...."

Remedies against unlawful government agency action

  Under American administrative law theory, courts have historically had oversight over administrative agencies at least with respect to their compliance with the legal standards governing their activities. Aggrieved individuals who believe they have been subject to illegal actions by public health agencies have sought relief in both state and federal courts. The administrative law principles governing judicial review of publichealth agency actions are much the same as those for other agencies. Generally, judicial review must be available and, absent express statutory review, the petition for judicial review must meet other requirements of the law for availability of review. More specifically, for non-statutory review, the petitioner must have standing. While the law of standing is complex, it basically involves demonstrating that the petitioner has sustained an injury or has an interest that is different from the public at large. In addition to procedural requirements, such as selecting the appropriate form of action (e.g., declaratory or injunctive relief), the second major issue is whether the timing of review is appropriate.

  The basic role of the court reviewing administrative agency actions is determining whether the agency complied with various legal standards. Generally, these standards are found either in the agency's enabling statute or, depending on the level of government involved, the applicable state administrative procedure act or the federal Administrative Procedure Act (APA). The APA standards and the standards in many state APAs include whether the agency action complied with the law; was not arbitrary, capricious, or an abuse of discretion; or, in a matter on the record in an agency hearing, was not supported by substantial evidence.

  An important basis for challenging actions of public health agencies is the denial of procedural due process rights in violation of the federal and/or state constitutions. Basically, the procedural due process doctrine generally requires that when government takes adverse action against protected interests in life, liberty, or property, the government must provide adequate and timely notice of the reasons for the adverse action, and accord a hearing before an unbiased decision-maker in which the aggrieved individual can present evidence and confront adverse witnesses and evidence.

  However, the procedural due process doctrine gives public health agencies great latitude when acting to protect public health and safety in emergency situations. Early on, the U.S. Supreme Court upheld the authority of public health agencies to act in summary fashion without hearings in emergencies. Specifically, in North American Cold Storage Co. v. Chicago, the court upheld a state law providing for the destruction of food in cold storage, after inspection and without a hearing, that public health authorities believed to be rotten and a hazard to public health.

  The scrutiny of public health regulation has been greater, and courts somewhat less permissive, when the regulation has concerned risks to health and safety in the environment or workplace. As "newer" regulation focused directly on business, there have been frequent challenges of state and federal efforts to enforce health and safety regulations for environmental control and workplace safety. Indeed, as discussed above, this newer generation of public health regulation has been controversial since its inception. Not surprisingly then, courts have been less willing to defer to agency judgments about the need for regulatory action in the environmental and workplace areas compared to traditional public health. Indeed, a great number of constitutional law cases address whether regulations designed to protect the public health actually have such a purpose or effect. When the public health regulation has addressed more conventional public health matters, such as the containment of emergent infectious disease, courts have been more particular in the demonstration of the purpose and effectiveness of the regulatory intervention.

 BEING EFFECTIVE WITH SCARCE RESOURCES

  In the modern regulatory state, administrative law has repeatedly been called on to design procedures for addressing disputed issues of science and technology that are vitally important and consequently politically charged. Arguably, the greatest challenge for administrative law since World War II has been the regulation of science and technology. Thus, administrative law scholars have wrestled with the issue of what processes best achieve accuracy in the content of agency policy and decisions, particularly those involving highly technical and scientific matters. In this regard, administrative law has addressed two relevant issues: (1) what are the most effective procedures for developing accurate and sound policies that guide agency regulatory decisions; and (2) how should agencies prioritize among competing and pressing issues that command immediate regulatory attention?

  Until the 1970s and the advent of a new generation of federal regulation designed to reduce occupational and environmental risks to health and safety, federal agencies had not used legislative rulemaking extensively. To implement the new regulations aimed at reducing risks to health and safety from economic activities, agencies generally used "notice and comment" rulemaking under ? 553 of the federal Administrative Procedures Act, which requires that agencies provide the public with notice of the proposed rule and an opportunity to comment. However, courts were not used to seeing legislative rules with such scope and effect and, as seemed intuitively logical, often concluded in many cases that additional procedures, such as cross-examination affording an opportunity to challenge the factual basis of scientific policies, were helpful in making better policy. In particular, the U.S. Court of Appeals for the District of Columbia Circuit began imposing additional procedural requirements on agencies that were making rules and other policy on highly technical matters, particularly in the environmental field. Congress likewise was putting additional procedural requirements in statutory rulemaking procedures, ostensibly to assure better consideration of the technical issues underlying legislative rules.

  However, American administrative law jurisprudence eventually rejected this vision of process for making rules and policy, even regarding scientific and technical issues. In its 1978 decision, Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, the U.S. Supreme Court definitively ruled that reviewing courts did not have the authority to impose additional procedural requirements to assure better development of highly technical, scientific issues in legislative rulemaking. Administrative law scholarship has, in the main, endorsed the concept that formal factfinding proceedings are neither necessary nor appropriate in addressing controversial scientific or other issues.

  At the federal level, the preferred model for rule- and policymaking is a legislative model. Such minimal process is sufficient given that rule- and policymaking proceedings are essentially legislative proceedings that deal primarily with "legislative facts," such as social science research findings, necessary to determine policy. Cross-examination and other judicial- type procedures are not especially effective in determining the veracity of legislative facts. While state rulemaking procedures vary, states are moving toward or have adopted the "notice and comment" model.

  Another important problem regarding rule- and policymaking is the appropriate scope of judicial review. In the last 25 years, the federal courts struggled to sort out the relationship between courts and agencies in the rulemaking process and, in particular, the extent to which regulated parties could challenge agency rules and policies in court. In its 1984 decision, Chevron U.S.A. v. Natural Resources Defense Council, the U.S. Supreme Court ruled that, absent a definitive statement to the contrary in the statute, agencies have considerable latitude in interpreting their enabling statutes and setting policy as long as such interpretations are reasonable. Since Chevron, courts have accorded similar deference to an agency's statutory interpretations beyond legislative rules. Also, over the years, exceptions to the application of Chevron have developed even when legislative rules are involved. Nevertheless, despite subsequent litigation and interpretation, Chevron has established that agencies -- not courts -- are the primary policymakers on regulatory matters within their jurisdiction. In so doing, Chevron clarified that interpreting a statute is often an exercise in making policy decisions rather than pure statutory interpretation.

  In sum, prevailing administrative law principles at the federal level and increasingly at the state level give great leeway to public health agencies in the procedures they invoke to make the requisite policies and decisions to meet today's challenges. As a practical matter, public health agencies are able to make rules and policy to respond to public health challenges fairly expeditiously and with little fear of judicial interference. They are also relatively free to use innovative regulatory techniques, including cooperation with private organizations, to reduce public health risks efficiently.

  Since the 1980s, scholarship in administrative law and policy science has turned its focus to a substantive critique of the pervasiveness and perceived irrationality of the 1970s generation of federal regulation aimed at reducing environmental and occupational risks. Much of the press for regulatory reform has occurred in relation to the regulation of environmental and occupational risks to health and safety from the economic activities of business. There have been two important dimensions to regulatory reform. The first has been the issue of making government regulation more effective and rational, particularly given that government agencies have generally had less staff and resources to discharge their regulatory responsibilities. The second has been an effort to improve the technical methodologies for assessing the risk to health and safety that constitute, for the most part, the content of their regulatory mission.

   Over the years and out of necessity because of greater resource and staff constraints, administrative agencies have become much more imaginative in the regulatory approaches they have taken to reduce risks to health and safety. They have often moved away from strict command-and-control regulation that prescribes and enforces standards for universal compliance. Often an agency will now establish a regulatory standard for a business or industry to meet, but not prescribe the method that the business must use in meeting the standard. Further, agencies are relying more on private accrediting bodies, professional organizations, and other private standard-setting organizations to assist industry in reducing health and safety risks. In addition, agencies are exploring voluntary regulation for reducing risks to health and safety. There have been, for example, several important efforts in this regard in the environmental field.

  The regulatory history of the Occupational Safety and Health Administration is instructive. In the early 1970s, OSHA promulgated rules to establish standards for toxic substances to limit exposure to cotton dust, vinyl chlorides, and other hazardous substances in the workplace. These regulatory efforts resulted in two major Supreme Court decisions on the validity of rules regulating toxic substances in the workplace. This litigation reflected the controversy and opposition from the business community in particular that attended OHSA in its early years and the subsequent ineffective performance of OSHA in regulating workplace safety. However, in more recent years, OSHA has turned to other regulatory approaches, such as fewer inspections and regulatory burdens for employers that engage in programs for voluntary compliance, with considerable improvement in the effectiveness of OSHA's regulatory responsibilities.

  In order to set proper priorities and conserve regulatory resources, choices have to be made regarding which public health problems to address and the best regulatory approach to be taken. An important way to make regulation more efficient is to conduct a better assessment of the risks to health and safety that are the subject of regulatory programs. Scholars in administrative law and policy science have paid considerable attention to improvement of the regulation of risks to health and safety. Scholars have analyzed whether risks are defined and measured correctly. They have analyzed proper methodologies for the analysis of risks versus benefits from regulatory measures to reduce risks. In addition, the importance of the acquisition and distribution of data about risk as a crucial part of risk assessment has been emphasized.

  One important issue regarding risk is the irrationality of perceptions of risk, particularly when the risk has attracted media and public concern. Often, in that event, the atmosphere in which agency decisions are made responding to the risk is politically charged and even emotional. Many have argued that public knowledge and pressure disproportionately influence policymakers. Others maintain that interest groups have too much influence in driving the agenda of risks to be addressed and the factors to be considered in their assessment.

  Risk assessment is especially important to public health agencies. Almost all public health regulation is about risk to health and safety. Specifically, much of public health regulation addresses ways to reduce risks to health and safety in the environment, workplace, and other settings. Also, much of public health practice involves educating the public about the risks of various practices and habits. Through sound risk assessment, a public health agency can make more accurate determinations of what are the most serious risks on which to focus regulatory attention. A good scientific understanding of the nature of the risk should suggest regulatory techniques that will be the most effective in addressing the risk at a reasonable cost. Public health agencies, in particular, need good data on which to base risk assessment.

  Further,how one evaluates various risks and the costs and benefits of regulatory programs to reduce risk invariably depends on one's political perspective. A major concern for business has been the regulatory mandates to reduce a wide variety of risks to health and safety in many different contexts. Regulated businesses and their interests are likely to see the costs of these mandates as greater than their benefits and vice-versa for members of the public and their advocacy groups. Not surprisingly, political and economic ideologies have greatly shaped the positions of policymakers and others on the assessment of risk and the design of regulatory strategies to reduce risk.

  In addition to using innovative approaches to regulation to maximize agency resources, public health agencies must carefully prioritize which risks to health and safety are the most important and warrant the greatest regulatory attention. The public health community must approach the definition and assessment of public health risks without ideological blinders and bring to bear the best of science on the resolution of public health problems. Otherwise, the public health community compromises the integrity and credibility of its risk assessment activities and its fundamental mission of reducing the risks to the population's health and safety.

  Perhaps most important, public health agencies must keep their political antenna up. Stepping ahead of the prevailing political consensus -- regardless of the merits -- can lead to trouble and the squandering of an agency's badly needed reputation for objectivity and professionalism. In particular, public health agencies must not step in to do by regulation what the legislature has been unable to do by legislation. Two recent court decisions adjudicating challenges to regulations addressing tobacco smoking -- one of the greatest public health scourges of all times, the prevention of which is surely a laudatory goal -- bear witness to this reality.

   In Food and Drug Administration v. Brown & Williamson Tobacco Corporation, with four justices in the dissent, the U.S. Supreme Court affirmed the Fourth Circuit's invalidation of the FDA's 1999 final rule to restrict the sale and distribution of cigarettes and smokeless tobacco products in order to protect children and adolescents. This rule was promulgated during the Clinton Administration in a highly visible campaign to address teen smoking after decades of congressional inaction. The Court reasoned that, reading the FDA's enabling statute "as a whole" and in conjunction with Congress's subsequent legislation regarding tobacco, "it is plain that Congress has not given the FDA the authority that it seeks to exercise here." The Court based its conclusion on two basic grounds. First, the Food, Drug and Cosmetic Act would have required the FDA to prohibit the distribution and sale of cigarettes as a dangerous drug or device, a categorization that the Court concluded did not "fit." Second, Congress has enacted other statutes that, in conjunction with the FDA's past resistance to claim jurisdiction over tobacco, indicate that Congress did not grant authority over tobacco to the FDA.

  Regardless of how one might feel about the merits of this decision and although the decision was controversial within the Court itself, it offers important guidance to public health agencies. Specifically, the distribution and sale of tobacco is a highly charged, controversial political issue even though the science establishing the serious health risks from smoking is well- established. The FDA's rule set a new course of policy that represented a sharp departure from its past positions and was an approach Congress was unable to take legislatively for lack of political consensus. Although one more vote would have resulted in a different Supreme Court decision, it was clear that the FDA and the Clinton Administration were ahead of Congress, although not necessarily the public, on the issue. As the Supreme Court observed in its decision:

    Nonetheless, no matter how "important, conspicuous, and controversial" the issue, and regardless of how likely the public is to hold the Executive Branch politically accountable, ... an administrative agency's power to regulate in the public interest must always be grounded in a valid grant of authority from Congress.

  The public health authorities in New York encountered a similar problem as the FDA when they sought to ban smoking in public places through an agency rule. In Boreali v. Axelrod, the New York Court of Appeals ruled that the state's public health council overstepped the boundaries of its lawfully delegated authority when it promulgated a comprehensive regulation to govern smoking in public areas. The court emphasized that New York's legislature had repeatedly defeated proposed legislation containing the same prohibitions as the rules.

  These cases exemplify perhaps the greatest regulatory challenge of all for public health agencies -- how to address risks to public health and safety when the requisite political consensus for direct regulation is absent. In such situations, there is still much public health agencies can do. They can engage in dispassionate risk assessment that brings the weight of sound science to bear on their arguments. It was this approach that ultimately brought low the powerful tobacco industry, albeit over decades. They can also work with private organizations representing regulated parties and consumers to achieve voluntary recognition and action on public health risks. Finally, they can engage in public health education -- advising the public of the particular risk with convincing, scientifically based information.

  In recent years, public health agencies and indeed the public health community at large have sought inspiration and support in meeting these challenges from new sources. The emerging field of public health ethics, with its emphasis on the traditions of the public health profession and, in particular, the moral trust that society bestows on public health professionals to act for the common welfare, has been particularly helpful in clarifying the true responsibilities of public health agencies in regulating risks to health and safety. Similarly, the importation of international human rights law and theory has provided great support and urgency to addressing problems that may be viewed as having a human rights imperative. This theoretic work in the discipline of public health will greatly facilitate the development of fair, effective, and democratic regulation for meeting present and future public health challenges.

CONCLUSION

  Administrative law has much to offer in assisting public health agencies meet the tremendous challenges that face them today. Administrative law can assist legislatures and public health agencies in clarifying the broad but specified powers for expeditious and effective public health regulation. Administrative law offers guidance in the procedures necessary to make rules and policies about controversial scientific issues that are accurate and effective, but also politically acceptable and enforceable. Sound rules and policy are essential, as they will give critical guidance for agency decisions in the implementation of public health regulation. Clearly, the best procedures for making any governmental policies and decisions are those that promote openness, public participation, and transparency to be sure that all relevant voices are heard and that the best relevant technical and scientific information is available to those making policy decisions. Finally, only regulation conceived in sound risk assessment and inspired by science, not ideology or emotion, will have the requisite credibility for political acceptance and ultimate effectiveness.

 
 
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 11/30/2002

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