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.
