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2
The Law and Public Health
Infrastructure
This chapter first describes the basic components of the public health
infrastructure1 and the organization of governmental public health in the
United States. Next, the committee discusses the laws that establish the mis-
sion, mandate, structure, capacity, governance, powers, and limits of public
health agencies at the national, state, tribal, and local levels. The committee
then reviews the recent history of public health law reform, and discusses
the changes needed to equip the governmental public health sector to lead
and support efforts to improve population health. Finally, the committee
discusses the critical question of public health federalism—that is, the op-
timal locus of responsibility and authority among the levels of government
with regard to health-relevant public policy.
THE ORGANIZATION OF GOVERNMENTAL
PUBLIC HEALTH IN THE UNITED STATES
The primary reason for the existence of government is to provide for the
health, safety, and welfare of the people (Gostin, 2010; Lopez and Frieden,
2007). In the United States, governmental public health responsibilities and
roles exist at three different levels: federal, state/tribal, and local/municipal.
The fundamental division of responsibility among these levels is defined by
1 The 2003 report The Future of the Public’s Health in the 21st Century used the term public
health infrastructure in reference to the array of public entities charged with keeping the public
healthy (e.g., agencies, laboratories, and partners) and to their operational capacity. CDC has
also defined three components of the basic public health infrastructure: workforce capacity
and competency, information and data systems, and organizational capacity (CDC, 2008).
27
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28 FOR THE PUBLIC’S HEALTH: REVITALIZING LAW AND POLICY
the fact that the Constitution leaves untouched the states’ sovereign power
(sometimes called “police powers,” discussed below) over most health issues
and limits the role of the federal government primarily to (1) regulation of
foreign and interstate commerce issues—and by extension, health issues and
threats that could affect commerce, and (2) the power to tax and spend for
the public welfare (Gostin, 2010; Grad, 2005).
The organization of public health at the federal level consists of the De-
partment of Health and Human Services (HHS), which includes the Centers
for Disease Control and Prevention (CDC) that function as the nation’s lead
public health agency, the Food and Drug Administration (FDA), and several
other pertinent agencies each of which has multiple functions relevant to
health. Other federal departments and agencies have health-related duties.
These include the Department of Agriculture, whose functions include set-
ting dietary guidelines, ensuring food safety, and administering the national
program that sets and enforces organic standards; the Environmental Pro-
tection Agency, which is charged with protecting Americans from risks to
health and to their environment; and the Occupational Health and Safety
Administration, in the Department of Labor, which is given oversight of
workplace safety and health issues. The federal public health agencies were
created by administrative statute, and their actions are authorized by the
Public Health Service Act first passed by Congress in 1944 and by a host of
other laws (Goodman et al., 2006).
Below the federal level, the organization of public health is similarly
complex, and the existing classification system for how public health is
structured has had numerous iterations over several decades (see for ex-
ample the earliest descriptions in DeFriese et al., 1981 and Miller et al.,
1977). Each structural arrangement may have advantages and disadvantages
in terms of the agencies’ ability to function and shape public policy, cultivate
legislative champions, and secure needed funding, but given the heterogene-
ity among agencies and locales, there is little research on the topic and very
limited resources to support it. First, there are four primary organizational
models for state public health agencies, depending on whether the public
health component is stand-alone or combined with other functions, such
as mental health, substance abuse and human services programs, although
this typology is often abridged to stand-alone agencies and umbrella agen-
cies (ASTHO, 2007) (see Box 2-1). The statutes or laws that authorize state
public health agencies are grounded in the US Constitution which both
constrains their actions and allows them significant powers. Second, three
models describe the administrative relationship between state and local
public health organizations (or how states deliver services). These include
a decentralized or home rule arrangement, under which local public health
agencies operate independently of the state and report to local government;
a centralized model in which there are no local public health agencies,
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THE LAW AND PUBLIC HEALTH INFRASTRUCTURE
BOX 2-1
Four Models of State Public Health Agency
Traditional Public Health Agency—an agency that oversees public health and
primary care only. While it may also administer one other health-related program
(i.e., environmental health, alcohol and drug abuse), its responsibilities are usually
limited to improving or protecting the overall health status of the public
Super Public Health Agency—an agency that oversees both public health and
primary care and substance abuse and mental health. This usually includes ad-
ministering services supported by the federal Substance Abuse Prevention and
Treatment Block Grant and the Community Mental Health Services Block Grant
programs
Super Health Agency—an agency that oversees public health and primary care
as well as the state Medicaid program
Umbrella Agency—an agency that oversees public health and primary care,
substance abuse and mental health, the Medicaid program, and other human
services programs
SOURCE: ASTHO, 2007.
though the state agency may have regional offices; and shared and mixed
authority models where the local agencies are responsible to both the state
public health agency and to local government, or where some local agencies
in a state report to the state agency while others operate solely under local
government control (NACCHO, 1998; Novick and Mays, 2005). Local
public health agencies in 29 states have decentralized (also called “home
rule,” or local) governance; local agencies in 6 states and the District of
Columbia have centralized (or state) governance, and 13 have shared or
mixed (state and local) governance (NACCHO, 2008). Local public health
agencies may also be categorized by geographic distribution as county, city,
city/county, township, and multi-county/district/regional—60 percent are
classified as county-type (NACCHO, 2001, 2008).2
Public health responsibilities at both the state and local levels generally
reside in multiple agencies, in addition to the public health agency. Each
state has its own legal framework for public health. All state public health
agencies have one or more foundational (or enabling) statutes (laws) that
provide the agencies with authority to conduct public health activities and
2A similar typology, but one that describes five types of local public health agencies, may
be found in NACCHO’s Local Public Health Agency Infrastructure: A Chart Book (2001).
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30 FOR THE PUBLIC’S HEALTH: REVITALIZING LAW AND POLICY
permit them to promulgate regulations and take action. Some state statutes
are detailed in outlining duties and powers, while others are broadly worded
and permit the agency to promulgate regulations as needed (ASTHO, 2007).
State public health statutes have been reviewed and well-characterized by
model Act efforts such as the Turning Point Model State Public Health Act
and the Model State Emergency Health Powers Act, both of which provide
templates for updating the statutory foundations of public health practice.
The rights, powers, and authorities of local governments have no special
standing under the U.S. Constitution, and are instead “either delegated by
the state legislature or derived directly as a grant of authority from the state
constitution” (Goodman et al., 2007, p. 57). Public health statutes of local
governments are less well characterized, in part because there are 2,794
local public health agencies (NACCHO, 2008) and “18,000 local jurisdic-
tions (e.g., counties, cities, boroughs, and special districts)” (McCarty et al.,
2009, p. 458). McCarty et al. (2009) have begun a process of identifying
the major categories of local ordinances that pertain to public health for a
range of local jurisdictions.
Boards of health are a historical mechanism for public health gover-
nance at the state and local level, but their roles have evolved over time, and
some have been dismantled entirely (Nicola, 2005). Eighty percent of local
public health agencies have an associated local board of health (NACCHO,
2008), and 23 states have a state board of health (Hughes et al., 2011).
Some local boards are advisory, and others play a role in governance and
policymaking. Their functions may include adopting public health regula-
tions, setting and imposing fees, approving the agency budget, hiring or
firing the top agency administrator, and requesting a public health levy
(Beitsch et al., 2010; Leahy and Fallon, 2005). State boards play varying
roles as well, including agency oversight, appointing the health officer, and a
quasi-legislative function (i.e., adopting/rejecting rules) and a quasi-judicial
function (i.e., enforcing rules) (Hughes et al., 2011).
State Police Powers
Police powers, which the states possess as sovereign governments pre-
ceding the U.S. Constitution, are the powers to safeguard the health, safety,
welfare, and morals of the population and may be exercised by public
health agencies (also called health departments), along with police, fire, and
sanitation departments (Lopez and Frieden, 2007) (see Box 2-2). States may
delegate this power to local governments and for health purposes to public
health and related agencies. Surveillance and required disease reporting are
exercises of state police powers. In some states, disease reporting is man-
dated in decades-old statutes, while in others, the statutes may be general,
and simply empower the state health commissioner or board of health to
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THE LAW AND PUBLIC HEALTH INFRASTRUCTURE
BOX 2-2
State Police Powers
Refers to authority of state to enact laws, promulgate regulations, and adjudicate to
(1) Protect, preserve, and promote
• Health
• Safety
• Morals
• General welfare
(2) Restrict private interests (within limits set by federal and state Constitutions):
• Personal interests—Autonomy, privacy, association, expression, liberty
• conomic interests—Contractual freedom, property uses, pursue trades
E
and occupations
SOURCE: Gostin, 2010.
“create, monitor, and revise the list of reportable diseases and conditions”
(Neslund et al., 2007, p. 224). In other states, this may be done either by
statute or by regulations promulgated by the health department. The First,
Fourth, Fifth, and Fourteenth Amendments provide procedural and substan-
tive safeguards that constrain the exercise of police powers, such as due
process and equal protection of the laws (see for example, Gostin, 2008).
The 3 Core Functions and 10 Essential Public Health Services
The fundamentals of government public health work have been distilled
in three Core Public Health Functions outlined in the Institute of Medicine
(IOM) report The Future of Public Health (1988). The functions are assess-
ment, policy development, and assurance. In 1994, the Core Public Health
Functions Steering Committee, which included federal government agencies
and major public health organizations, developed the 10 Essential Public
Health Services (10 EPHS) framework (see Box 2-3).3 The 10 EPHS have
been used as a tool for planning, implementation, and evaluation in public
health. Given their purpose to illustrate the range of public health practice,
3 The American Public Health Association, the Association of Schools of Public Health, the
Association of State and Territorial Health Officials, the Environmental Council of the States,
the National Association of County and City Health Officials, the National Association of State
Alcohol and Drug Abuse Directors, the National Association of State Mental Health Program
Directors, and the Public Health Foundation.
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32 FOR THE PUBLIC’S HEALTH: REVITALIZING LAW AND POLICY
BOX 2-3
The 10 Essential Public Health Services
1. Monitor health status to identify and solve community health problems.
2. Diagnose and investigate health problems and health hazards in the
community.
3. Inform, educate, and empower people about health issues.
4. Mobilize community partnerships and action to identify and solve health
problems.
5. Develop policies and plans that support individual and community health
efforts.
6. Enforce laws and regulations that protect health and ensure safety.
7. Link people to needed personal health services and assure the provision of
health care when otherwise unavailable.
8. Assure a competent public and personal health care workforce.
9. Evaluate effectiveness, accessibility, and quality of personal and population-
based health services.
10. Research for new insights and innovative solutions to health problems.
SOURCE: Public Health Functions Steering Committee, 1994.
they are extremely broad and somewhat vague. Also, the 10 EPHS are not
simply the province of governmental public health agencies. Other organiza-
tions deliver services and conduct activities that may be categorized under
one or more of the EPHS. However, the 10 EPHS do necessarily spell out the
roles of non-health or non-governmental public health actors, or provide a
map for implementing health in all policies approaches (intersectoral efforts
to consider the health implications of non-health policies).
Essential Service 7 warrants attention in the context of implementing
the Affordable Care Act. For decades, the public health practitioner com-
munity has expressed ambivalence about its role in the provision of limited,
generally primary clinical care services as part of a safety net for uninsured
and vulnerable populations. This role—providing, not just assuring the
delivery of care—has channeled some additional resources to public health
agencies, but has both perpetuated the misperception of public health as
primarily publicly-funded medical care for the indigent and has been seen
by many public health leaders as a programmatic distraction from dis-
charging population-oriented responsibilities (Brooks et al., 2009; IOM,
2003a). Work by Honoré in Missouri (Honoré and Schlechte, 2007) and
Brooks and colleagues in Florida (Brooks et al., 2009) has showed that a
large, disproportionate percentage of public health funds are dedicated to
Essential Service 7 to the detriment of agency ability to adequately attend
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THE LAW AND PUBLIC HEALTH INFRASTRUCTURE
to the other nine essential services. As discussed in and since the IOM re-
port The Future of the Public’s Health in the 21st Century (IOM, 2003b),
many public health commentators believe that a well-functioning medical
care system and expanded access to all or most of the population will free
the public health agencies to focus on the “assurance” aspect of Essential
Service 7 (e.g., ensuring access to care, linking people to needed care, as-
sessing the quality of the care delivered in the community, and assessing and
strengthening community supports for good health), rather than engage in
the direct provision of clinical services (IOM, 2003b).
MODERNIZING PUBLIC HEALTH STATUTES
Many public health statutes have not been systematically updated in
decades or more. They do not reflect current circumstances, provide insuf-
ficient mandates and powers, and guarantee human rights protections that
might be interpreted judicially as overbroad (Meier et al., 2009b; National
Association of Attorneys General, 2003). Antiquated laws can be confus-
ing, fragmented, and duplicative. Older public health laws were, of course,
informed by the scientific standards of the day and by the statutory context
and constitutional jurisprudence of their time, including conceptions of
individual rights. In addition, some laws were enacted in piecemeal fashion
in reaction to a specific health problem (e.g., a disease outbreak), leading to
layers of statutory accretion rather than holistic or comprehensive legisla-
tion (Gostin et al., 2008, p. 676).
Public health laws need to be sufficiently broad to deal with unforeseen
threats, while still giving public officials clearly specified powers and limits.
Many of the antiquated laws currently on the books focus on infectious dis-
eases, but lack specific powers and responsibilities for chronic diseases and
injuries. They also lack specific authority to exercise modern functions such
as managing immunization registries and syndromic surveillance systems,
and conducting interventions, in collaboration with other sectors, to alter
the built environment. At the same time, antiquated statutes predate the vast
expansion of knowledge about the socioeconomic determinants of health
and their role in the complex pathways to chronic disease and other poor
health outcomes. Extant statutes also frequently fail to protect individual
rights such as privacy, nondiscrimination, and due process. Consequently,
policymakers must systematically and comprehensively review public health
statutes to ensure that sufficient and clear authority is in place, together with
safeguards of individual rights.
The challenges presented by outdated laws are most starkly apparent
in the context of preparedness for public health emergencies (see Box 2-4).
The preparedness component of public health agency activities developed
significantly in the last decade of the 20th century because of federal and
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34 FOR THE PUBLIC’S HEALTH: REVITALIZING LAW AND POLICY
BOX 2-4
Preparedness Laws: Still in Need of Reform
“Existing state laws may thwart effective surveillance activities. Many states do not
require timely reporting for the most dangerous agents of bioterrorism. Most states do
not require immediate reporting for all the critical agents identified by the CDC [Centers
for Disease Control and Prevention]. At the same time, states do not require, and may
actually prohibit, public health agencies from monitoring data collected through the
health care system. Private information held by hospitals, managed care organizations,
and pharmacies that might lead to early detection of a public health threat, such as
unusual clusters of fevers or gastrointestinal symptoms, may be unavailable to public
health officials because of insufficient reporting mechanisms or privacy concerns” (The
Centers for Law and the Public’s Health, 2010).
Although the Model State Emergency Health Powers Act was implemented to vary-
ing degree by a number of jurisdictions around the country, the general state of legal
preparedness of public health emergencies such as epidemics and bioterrorist attacks
remains deficient.
The CDC, the nation’s top public health agency, has powers “to quarantine, inspect,
disinfect and even destroy animals that are sources of dangerous infection to humans”
that have “limited applicability to a few diseases. If the CDC did try to exercise power in
response to swine flu, its legal authority would surely be challenged, causing needless
delays and uncertainty—and its actions might be ruled unconstitutional. To its credit, the
CDC has tried for more than a decade to modernize its legal authority. But its proposed
congressional interest in public health readiness for deliberately introduced
biological, chemical and other threats to the public’s health. These efforts,
which received legislative attention in the late 1990s, intensified after the
events of September and October 2001, including a major focus on the
legal aspects of preparing for bioterrorism and other types of disasters.
Goodman and colleagues have described the core elements of public health
legal preparedness: essential legal authorities, competencies to apply laws,
coordination across jurisdictions and sectors, and information about public
health law best practices (Goodman et al., 2006). Preparedness cuts across
many of the 10 EPHS.
In addition to the factors described above, other major shifts have
occurred in the backdrop to public health laws, including demographics,
health challenges, and in aspects of public health practice. For example,
the population lives much longer and the age distribution of the popula-
tion ranges across a much wider lifespan than was the case when some
early public health laws were framed. Americans live very different lives
than they did even 30 years ago. Examples are changes in how they com-
municate, grow food, and transport themselves. The infectious diseases
common a century ago pose far less of a threat in contemporary life in
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THE LAW AND PUBLIC HEALTH INFRASTRUCTURE
fundamental revision was submitted more than three years ago, and regulations have
yet to be finalized” (Gostin, 2009).
In addition, based on reports from Association of State and Territorial Health Officials
(2010) and the National Association of County and City Health Officials (2010) that were
prepared for the CDC following the H1NI epidemic, O’Connor and colleagues (2011)
identified several areas where laws and policies at all levels of government were not
adequate to meet the needs of the public. They stated that “although progress in public
health legal preparedness has been made since 2001, it is apparent from the law and
policy challenges encountered during H1N1 that no single U.S. jurisdiction—state, local,
tribal, or federal—is yet fully legally prepared to respond to a major public health threat.”
Key issues they identified include vaccine allocation, distribution, and dispensing issues;
coordination among levels of government about the use of stockpiled material; and the
need for sustainable public health response funding. The authors noted that the laws
and policies related to the vaccine campaign “presented significant challenges, espe-
cially for state and local public health responders,” including decisions on vaccine avail-
ability, formulation, allocation, prioritization, and guidance as well as tracking, recalls,
and adverse event reporting. “Use and accounting for stockpiled materiel raised many
policy and legal questions during 2009 H1N1.” Funding from Public Health Emergency
Response was also restricted. The allowable methods for distributing the funds limited
state and local flexibility for their use which ultimately slowed their ability to implement
public health measures (O’Connor et al., 2011, pp. 53, 54).
the United States compared to chronic disease and the potential of longer
life in diminished health (Kominski et al., 2002; Vaca et al., 2011; Woolf
et al., 2010). Approximately two thirds of the adult population (Calle
and Kaaks, 2004) and a growing proportion of children are overweight
or obese (Center for Health Improvement, 2009), changing the profile of
chronic disease patterns in the U.S. population. The empirical evidence
about what creates and impairs health on the population level has con-
tinued to evolve, clarifying that medical care contributes far less to health
outcomes than do the broader societal, environmental, and economic
conditions that strongly influence human behavior (see Braveman et al.,
2011; Cutler et al., 2006; McGinnis et al., 2002). Given the enhanced and
evolving understanding of the causes of poor health and death in the popu-
lation, public health tools and approaches are also changing. Furthermore,
fundamental transformations are taking place in public health practice and
in the health system in general. These changes offer opportunities for legal
reforms to ensure modern laws and regulations meet contemporary needs,
in addition to conforming to evolving science and evidence to address the
major health hazards facing the population.
Public health statutes at the state level do not generally reflect the con-
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36 FOR THE PUBLIC’S HEALTH: REVITALIZING LAW AND POLICY
temporary causes of poor health. State laws often feature specific references
to communicable disease duties of public health agencies, while making
no explicit reference to chronic diseases and injuries. Meier et al. (2009a)
conducted a 50-state comparison of enabling public statutes against the
standards of the 10 Essential Public Health Services and the 6-part mis-
sion of public health (like the EPHS, the mission4 was defined in the 1994
HHS document Public Health in America). The study’s findings aside, it is
important to note that the mission statements refer to injuries and infec-
tious disease, and the 10 EPHS refer very broadly to “health problems.”
However, the lack of explicit reference to, for example, the leading causes
of death (i.e., chronic disease), may lead to a limited understanding among
policymakers and the public about the role of public health agencies. Such
narrow understanding leads to inadequate funding for the full breadth of
public health services necessary to safeguard the health of the public.
When considering the need for change in contemporary public health
law, there are several contextual factors and fundamental transformations
that must be considered, including
• n
ational health legislation that holds the promise of expanding ac-
cess to medical care, thus partially releasing public health agencies
from the need to provide safety net clinical services;
• a
renewed emphasis on and commitment to quality performance
and accountability of public health agencies (e.g., the national
Public Health Accreditation effort, the 2008 HHS Consensus State-
ment on Quality in the Public Health System 2009), and the 2007
Pandemic and All Hazards Preparedness Act provision requiring
development of performance standards and measures by (Nelson
et al., 2007); and
• m
ultiple recent developments—legislative, technologic, and practi-
cal or operational—in the health information arena that have pro-
found implications for public health practice and for its relationship
to clinical care (e.g., the American Recovery and Reinvestment Act
of 2009 provisions for health information technology, including
payments to spur adoption of electronic medical records; the estab-
lishment of Regional Health Information Organizations to facilitate
health information exchange across institutions in a community or
region; and the development of the Meaningful Use concepts which
4 The mission of public health: (1) Prevents epidemics and the spread of disease; (2) Protects
against environmental hazards; (3) Prevents injuries; (4) Promotes and encourages healthy
behaviors; (5) Responds to disasters and assists communities in recovery; and (6) Ensures the
quality and accessibility of health services (Public Health Functions Steering Committee, 1994).
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THE LAW AND PUBLIC HEALTH INFRASTRUCTURE
include some consideration of public or population health needs as
part of health information networks).
The changes outlined above are likely to have implications for the legal and
policy aspects of public health practice. The growing understanding of the
multiple determinants of health also requires attention to the adequacy of
existing public health statutes. It also will require public health agencies to
have greater public policy expertise and capacity in interactions with the
heads of the Executive Branch to whom they report (e.g. mayors, gover-
nors), the Legislative Branch, and other sectors of government.
Prior Efforts to Update Public Health Law
Two major efforts to review and update public health law took place
around the turn of the 21st century: the Turning Point Model State Public
Health Act (1997–2003) and Model State Emergency Health Powers Act
(MSEHPA, 2001–2002) (Gostin et al., 2002). The Turning Point Model
State Public Health Act was a broad (though not comprehensive) sample law
composed of nine articles and incorporated two other model acts—a revised
version of the MSEHPA in the article pertaining to emergency powers, and
the Model State Privacy Act (Gostin et al., 2001). The Turning Point Act
presents the broad mission of state and local public health agencies to be
conducted in collaboration with other stakeholders, and provides language
for updating laws pertinent to the traditional powers of public health agen-
cies (e.g., communicable disease control nuisance abatement, inspections)
(Public Health Statute Modernization National Excellence Collaborative,
2003). As of August 2007, “subject matter or specific language from the
Turning Point Act” was featured or introduced in whole or part through
133 bills or resolutions in 33 states, and 48 of these bills or resolutions
have passed (The Centers for Law and the Public’s Health, 2007). Box 2-5
provides some lessons from the experience of four states that participated in
the Turning Point Collaborative. These illustrate how widely circumstances
may vary from one state to another: the level of interest of public health
attorneys in the public health agency; the array and relationships among
champions and advocates of public health law reform; the nature of the
political establishment; and the level of interest in the administration and
legislature currently in power.
Despite the development and dissemination of the model Acts and their
generally partial adoption, by some state governments, much of public
health law in jurisdictions around the country was crafted in the late 19th
and early 20th centuries and remains largely unchanged. Also, Meier et
al. (2009a) have demonstrated on the basis of an analysis of state codes in
comparison to the public health mission and essential services described in
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46 FOR THE PUBLIC’S HEALTH: REVITALIZING LAW AND POLICY
cedural requirements of a given course of action; and undertakes
research and provides legal opinions
2. Protector of confidentiality: Exercise vigilance to protect infor-
mation in the custody of a health department from Freedom of
Information Law8 (FOIL) requests and subpoenas, but also role
as educator on the public health exception to Health Insurance
Portability and Accessibility Act (HIPAA) (disclosures required by
law, e.g., in the case of public health surveillance or epidemiologic
investigations)
3. Legislative and regulatory counsel: Ensure that changes to the
health code or regulations enacted comply with the law (will ana-
lyze the statutory basis and legal viability of health officer’s propos-
als, will prepare language for the basis and purpose of the rule, and
the actual language of the resolution)
4. Enforcement: Agency exercises police powers by issuing valid and
enforceable orders (compelling directly observed tuberculosis treat-
ment, or ordering lead abatement in a rental residence with peeling
lead paint and children ages 10 or younger).
5. Miscellaneous duties: Public health counsel may be called on to
carry out additional duties, including preparing contracts with out-
side organizations and vendors; advise in cases of employee-related
conflicts of interest; handle disciplinary matters (other than criminal
or corrupt behavior requiring the inspector general); investigate
when human rights cases, such as involving discrimination or sexual
harassment are brought against the department; and act as litigation
liaison in cases of litigation against the health agency or by the local
government (Lopez and Frieden, 2007).
Public health agencies access legal counsel in different ways, and their
choices may in part be influenced by their size, governance structure, or both
(IOM, 2010b; Pestronk, 2010). Some agencies have internal counsel that is
part of the agency staff. Other agencies have external counsel that is drawn
from the state attorney general’s office, state health department, county or
city counsel, or simply private counsel. Some agencies may have both types.
The type of legal counsel available to a public health officer may present
challenges for the work of agencies. For example, legal counsel that serves
another client (e.g., local government or the mayor) may be influenced by
potentially conflicting agendas, political influences, timelines, and various
priorities. This may also mean that counsel has expertise in public policy,
but not necessarily specific public health knowledge or any appreciable un-
derstanding of public health law. Respondents to an Association of State and
8 In some states, this is known as the Open Records Act.
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Territorial Health Officials survey reported that many local public health
agencies have counsel that is only part-time and frequently lacks public
health knowledge (ASTHO, 2008).
Although it is preferable for the public health counsel to report to the
health officer, sometimes it may be necessary for the attorney to organiza-
tionally report to an outside entity such as an attorney general. Because the
vast majority of attorneys general are independently elected, such arrange-
ments raise the potential for the public health legal advisor to report to
someone other than the person to whom the health officer reports, typically
the chief executive. Adequate legal counsel needs to be readily accessible to
be present at all high-level policy discussions in the department to facilitate
clear understanding of the legal rationale underlying public health initia-
tives or interventions before issues become crises. Hiring attorneys with
grant funds and embedding them within particular grant-funded programs
to work in an isolated manner may also not be optimal.9 Moreover, the
increasing availability of legal assistance from several existing national
academic or not-for profit sources such as the Public Health Law Network,
while beneficial, cannot take the place of an official legal advisor that is
recognized by, and part of the same team as the health officer and the juris-
diction’s chief executive.
Public health agency legal counsel would require training in public
health and in public health law, and should have knowledge and experience
in the following areas:
• L
aws that establish the public health agency and set forth its juris-
diction and authorities
• P
rogrammatic aspects of the agency’s work
• P
rocedures and processes consistent with applicable laws and
policies
Such experience can be obtained through adequate career ladders within a
health department, through education or, ideally, a combination of both.
One of the prerequisites for strengthening public health law capacity in
health departments is the availability of legal training in schools of public
health (e.g., for individuals wishing to pursue a J.D./M.P.H. degree and
for other public health students) and in schools of law for individuals
interested in public policy and especially health policy. Schools of law
offer little on public health law, and the professional education resources
available to train public health personnel and legal professionals on public
9 Personal communication with Wilfredo Lopez, Former General Counsel for Health to the
New York City Department of Health and Mental Hygiene Current Counsel Emeritus to the
New York City Health Department and Board of Health , May 19, 2011; and Steve M. Teutsch,
Chief Science Officer Los Angeles County Public Health, May 19, 2011.
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48 FOR THE PUBLIC’S HEALTH: REVITALIZING LAW AND POLICY
health law are generally limited (Goodman et al., 2002; IOM, 2003c;
PHLA, 2004).
Recommendation 4: The committee recommends that every public
health agency in the country have adequate access to dedicated
governmental legal counsel with public health expertise.
The committee emphasizes “access to” to make it clear that it is not recom-
mending a one-size-fits-all approach (e.g., a full-time public health attorney
for every public health agency, no matter how small), but rather, that dif-
ferent strategies are needed to ensure that public health agencies can obtain
quality legal advice from attorneys with pertinent expertise. For example,
approaches such as regionalization will be needed to ensure that every public
health agency possesses the needed capabilities, either on its own, or through
collaborative linkages.
Even in today’s constrained fiscal environment, solutions to a shortage
of adequate legal counsel could potentially be addressed by placing a law-
yer from the attorney general’s office who is currently assigned to advise
the health department within the health department thus facilitating close
working relationships between counsel and practitioners.
THE LOCUS OF GOVERNMENT RESPONSIBILITY
FOR THE PUBLIC’S HEALTH
In this section, the committee addresses central issues that emerge from
the preceding discussion of the ways in which laws define and constrain the
roles and authorities of the federal, state, and local levels of government.
These include the duty and responsibility of each level of government per-
taining to population health and the optimal level of government to act to
create the most beneficial conditions for the population’s health.
Gostin has written that “[t]he level of government best situated for deal-
ing with public health threats depends on the evidence identifying the nature
and origin of the specific threat, the resources available to each unit for ad-
dressing the problem, and the probability of strategic success” (Gostin and
Powers, 2006, p. 1056). Following logically from this is that national-level
crises such as pandemics and bioterrorism threats require the substantial
resources of the federal government, while a localized environmental threat
may only require the involvement of the local public health agency.
Preemption is an area of considerable contention among the three levels
of government because it involves a higher level of government restricting
or eliminating a lower level of government’s regulatory ability on an issue
(NPLAN and Public Health Law Center, 2010). The Constitution grants
Congress and federal regulators broad authority to preempt, and states
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THE LAW AND PUBLIC HEALTH INFRASTRUCTURE
have similarly broad powers to preempt municipalities (this may depend
somewhat on how municipal powers are granted or revoked by the state)
(Public Health Law Center, 2010).
“Floor” preemption refers to federal or state laws or regulations that
set and enforce a minimum standard, and permit lower levels of government
to not enact statutes or promulgate regulations that go above that minimal
standard. For example, the Health Insurance Portability and Accessibility
Act, HIPAA, sets a protective floor for privacy protection, but allows the
states to enact stricter privacy standards. Ceiling preemption refers to feder-
al or state laws or regulations that set a maximum standard that lower-level
governments may not exceed. The recently passed federal Affordable Care
Act effectively preempts state and local authorities from requiring menu
labeling that differs from the federal standards in restaurants and vending
machines covered by the federal law. Many public health advocates express
concern with ceiling preemption because it does not allow ample scope for
states and localities to innovate in the field of public health (NPLAN, 2009).
Federal or state (ceiling) preemption of state and local authority can often
be harmful from a public health standpoint because it can compromise the
ability of public health practitioners to implement more stringent standards
that may be important and well accepted in a local setting. Ceiling preemp-
tion also interferes with local control over local needs and with local-level
accountability, and it could limit the ability of jurisdictions to meet the
needs of constituents.
In a few areas of public health, federal preemption seems highly appro-
priate. For example, federal oversight of food manufacturing and process-
ing may be appropriate because of its close nexus to interstate commerce.
(However, localities regulate sanitary standards for and grant permits to
food establishments.) Another example may be found in the federal ban
on smoking on airplanes—the interstate nature of airline flight makes this
area ideally suited to federal preemption. Ceiling preemption is appropri-
ate in situations where national uniformity is absolutely necessary and only
after the impact on public health and enforceability has been thoroughly
assessed and mitigated. A good example of preemption with strong public
health benefit is found in the 2011 U.S. Supreme Court case of Bruesewitz v.
Wyeth LLC. In that case, the Court held that the National Childhood Vac-
cine Injury Act of 1986 preempts all claims against vaccine manufacturers
for injuries or death purported to be related to a vaccine (NEDSS, 2001).
The Court’s decision upheld the law that established the Vaccine Injury
Compensation Program that requires vaccine safety and effectiveness while
removing the threat of litigation from vaccine manufacturers.
A recent White House document cautioned against excessive agency
preemption because “[t]hroughout our history, state and local govern-
ments have frequently protected health, safety, and the environment more
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50 FOR THE PUBLIC’S HEALTH: REVITALIZING LAW AND POLICY
aggressively than has the national government.”10 Furthermore, the federal
government does not have the police powers granted to states in the area
of health and safety.
Another example where federal ceiling preemption is relevant is the
content, packaging, or labeling of packaged foods that are manufactured
or processed in one state and shipped across many states in packaged form
for distribution and consumption. However, in an area such as public
health that is primarily the province of a state’s police power, the need for
preemption and the kind of preemption that may be warranted should be
closely examined on a case-by-case basis, and the presumption should be
that “floor” preemption is the more appropriate option in the area of public
health. For example, one can argue that the preemption provisions put into
the 1969 amendments to the Federal Cigarette Labeling and Advertising
Act should not prohibit a local health department from requiring local ciga-
rette retailers to post warning signs about the dangers of smoking. Such a
requirement would not affect the manufacturing, packaging, or labeling of
cigarettes produced in one state and transported in interstate commerce. Yet,
a recent federal court decision struck down such a requirement in New York
City on the grounds that it was preempted by the language of the federal
statute.11 Here, the need for preemption would seem to be outweighed by
the detrimental impact on public health and local control.
Preemption in the field of public health may also lead to non-enforce-
ment of a preemptive federal standard. As discussed below, when a federal
agency is given preemptive authority to regulate in an area that local public
health agencies have a greater capacity and infrastructure to regulate, the
result will likely be that the public health measure will not be enforced. In
such instances preemption, and certainly “ceiling” preemption, needs to
be avoided or arrangements for local enforcement should be put in place.
The use of law as a tool often requires an integrated strategic approach.
When considering the appropriateness of preemption the impact on public
health and enforceability must be assessed. As the federal government em-
barks on a regulatory review to ascertain if federal regulations unnecessarily
hamper business activity, the committee urges that this principle be upheld
and efforts be made to avoid creating new or interpreting existing preemp-
tive laws in ways that may have unintended and unhealthful consequences.
Recommendation 5: The committee recommends that when the
federal government regulates state authority, and the states regulate
10 See Memorandum for the Heads of Executive Departments and Agencies, Office of the
Press Secretary, The White House, 2009 WL 1398319 (May 20, 2009).
11 See Grocery Corps v. New York City Health Department Case 1:10-cv-04392-JSR Docu-
ment 63 (12-29-10).
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THE LAW AND PUBLIC HEALTH INFRASTRUCTURE
local authority in the area of public health, their actions, wherever
appropriate, should set minimum standards (floor preemption) al-
lowing states and localities to further protect the health and safety
of their inhabitants. Preemption should avoid language that hinders
public health action.
The IOM recently recommended that the FDA modify its GRAS (Gen-
erally Regarded as Safe) standard relative to the amount of sodium in
packaged food and in food prepared in restaurants (IOM, 2010a). Such an
initiative would extend helpful public health protections nationally, but they
would vest the FDA with regulatory authority over facilities that it has not
regulated in the past. Food service establishments such as restaurants have
historically been regulated and inspected by state and local health depart-
ments, and these agencies have well-established, albeit strained, inspection
workforces in place. There is also an adjudicatory infrastructure, such as
state courts or administrative tribunals, to enforce the sanitary laws and
regulations under the auspices of public health agencies. Whether a state
or local health department can enforce a federal health standard in a res-
taurant, for example, can be a legally complex matter potentially subject
to interpretation. One example of such complexity can be found in Section
337(a) of the Food, Drug, and Cosmetics Act (FDCA), which in part reads,
“Except as provided in subsection (b) of this section, all such proceedings for
the enforcement, or to restrain violations, of the chapter shall be by and in
the name of the United States.” That is, only the federal government can en-
force that chapter. However, subdivision (1) of subsection (b) specifies that,
“A State may bring in its own name and within its jurisdiction proceedings
for the civil enforcement, or to restrain violations of” eight listed sections
of the FDCA. This provision would seem to authorize at least states, if not
their municipal subdivisions, to enforce those listed sections in state courts
and possibly state tribunals.
The intended point is that in times of increasing fiscal distress at all
levels of government, protective federal health measures that are vested
within the jurisdiction of a federal agency to enforce should not be allowed
to go unheeded, unimplemented, and unenforced if there are cost-effective
means to implement them. For example, if a state or local health depart-
ment has a workforce that regularly inspects restaurants, and a judicial or
administrative body to adjudicate violations, it would appear obvious that
it would be more efficient for such an agency to enforce a federal standard
than it would for the federal agency to create a new infrastructure to directly
enforce a federal standard in a domain entirely new to it. Federal agencies
must make every effort to leverage resources, and work cooperatively with
the states to facilitate enforcement of federal standards by states or locali-
ties where the statutory or regulatory structure would allow. However, it
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52 FOR THE PUBLIC’S HEALTH: REVITALIZING LAW AND POLICY
would not be helpful to mandate that states and localities assume this federal
responsibility without adequate funding to do so.
Recommendation 6: The committee recommends that federal agen-
cies, in collaboration with states, facilitate state and local enforce-
ment of federal public health and safety standards, including the
ability to use state or local courts or administrative bodies where
appropriate. Federal, state, and local agencies should combine
their resources, especially in areas where regulatory authority is
vested in one level of government but enforcement capacity exists
in another level.
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