Authorizing legislation

Selected Federal Legal Authorities Pertinent to Public Health
Emergencies
Prepared by the Public Health Law Program
Centers for Disease Control and Prevention
Updated August 2014 1

Introduction

In the wake of the 2001 terrorist attacks, the 2003 severe acute respiratory syndrome (SARS) epidemic, Hurricane
Katrina in 2005, the influenza A (H1N1) pandemic in 2009, Hurricane Sandy in 2012, and the ongoing concern about
future similar events, public health officials have acted to strengthen their jurisdictions’ legal preparedness for all types
of public health emergencies.
Federal laws and legal authorities address a variety of concerns central to public health emergencies, such as
emergency declarations, quarantine and isolation, liability and licensure of workers, and mutual aid, among others.
Because these laws involve multiple federal agencies and appear in many official documents, the Centers for Disease
Control and Prevention’s (CDC) Public Health Law Program prepared the following annotated list of selected,
commonly cited federal legal authorities for reference by public health officials, legal counsel, and others.
This compilation is subject to three caveats: 1) it is not intended to be exhaustive of all relevant legal authority; 2) it
was compiled in September 2009 and updated in 2014, and reflects the laws current at the time; and 3) only selected
portions of the laws relevant to public health emergencies are presented.

Disclaimer

The Public Health Law Program (PHLP) provides technical assistance and public health law resources to advance the
use of law as a public health tool. PHLP cannot provide legal advice on any issue and cannot represent any individual
or entity in any matter. PHLP recommends seeking the advice of an attorney or other qualified professional with
questions regarding the application of law to a specific circumstance. The findings and conclusions in this document
are those of the author and do not necessarily represent the official views of the Centers for Disease Control and
Prevention.

Topics

General Emergency Legal Authorities
Legal Authorities Specific to Public Health Emergencies
Public Safety and Security
Control of Communicable Diseases
Managing Transportation
Managing Animals, Food, and Other Property
Liability, Workers’ Compensation, and Licensure
Personal Health Information and Privacy
Related Federal Guidance

Originally drafted in 2009 by Stacie Kershner, J.D., an Oak Ridge Institute for Science and Education legal fellow at CDC’s
Public Health Law Program. Updated by Gregory Sunshine, J.D., an Oak Ridge Institute for Science and Education legal fellow at
CDC’s Public Health Law Program. Special thanks to the CDC partners who helped develop this resource.

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Please note that some laws listed have broad application and thus may be included under more than one topic area;
only the relevant portion of the law is discussed under each topic area. These laws might have other provisions not
discussed here.

General Emergency Legal Authorities
•

Homeland Security Act of 2002
Pub. L. No. 107-296, as amended; 6 U.S.C. §§ 311–321m
The Homeland Security Act merges twenty-two disparate agencies and organizations into the new
Department of Homeland Security (DHS), including the Federal Emergency Management Agency (FEMA).
The Act charges DHS with securing the nation against terrorist attacks and carrying out the functions of all
transferred entities, including acting as a focal point regarding natural and man-made crises and emergency
planning. The law establishes the National Homeland Security Council, the Directorate of Border and
Transportation Security, the Office for State and Local Government Coordination, and transfers powers
from Immigration and Naturalization Service (abolished under 6 U.S.C. § 291(a)).

•

Post-Katrina Emergency Management Reform Act of 2006 (Post-Katrina Act)
Pub. L. No. 109-295; 6 U.S.C. §§ 701 et. seq.
Enacted as part of the Department of Homeland Security Appropriations Act, 2007, the Post-Katrina Act is
intended to address various shortcomings identified in the preparation for and response to Hurricane Katrina.
The Act establishes new DHS leadership positions, brings additional functions into FEMA, creates and
reallocates functions to other components within DHS, and amends the Homeland Security Act in ways that
both directly and indirectly affect the organization and functions of various entities within DHS. The Act
enhances FEMA’s responsibilities and its autonomy within DHS.

•

Robert T. Stafford Disaster Relief and Emergency Assistance Act of 1988 (Stafford Act)
Pub. L. No. 93-288, as amended; 42 U.S.C. §§ 5121–5207
The Stafford Act authorizes the President to declare a “major disaster” or “emergency” in response to an
event (or threat) that overwhelms state or local governments. Declaration under the Act triggers access to
federal technical, financial, logistical, and other assistance to state and local governments. The Act directs
FEMA to coordinate administration of disaster relief to the states. The governor of an affected state must
first respond to the disaster and execute the state’s emergency plan before requesting that the President
declare a major disaster or emergency, and the governor must certify that the magnitude of the emergency
exceeds the state’s capability. As of 2013, tribal leaders can also request a Stafford Act declaration from the
President (see Sandy Recovery Improvement Act of 2013 below). The President may declare an emergency
without the request of a governor or tribal leader if the emergency involves “federal primary responsibility”
(such as an event occurring on federal property, for example the bombing of the Murrah Federal Building in
1995). Title VI of the Act provides for a national system for all-hazards emergency preparedness, with
authority located at both the federal and state levels.

•

Sandy Recovery Improvement Act of 2013
Pub. L. No. 113-2 §§ 1101–1111; 42 U.S.C. §§ 5170, 5191
The Sandy Recovery Improvement Act authorizes the chief executive of a tribal government to directly
request disaster or emergency declaration from the President, much as a governor can for a state. Previously,
tribal groups were treated like local governments in that they could receive a federal disaster declaration only
if the governor of the state in which the tribe was located requested one.

•

Sections 201 and 301 of the National Emergencies Act
50 U.S.C. §§ 1621, 1631
The National Emergencies Act authorizes the President to declare a “national emergency.” The proclamation
of a national emergency must be transmitted immediately to Congress and published in the Federal Register.
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The declaration of emergency (or contemporaneous or subsequent executive orders) must specify the powers
or authorities made available by virtue of the declaration. A national emergency can be terminated if the
President issues a proclamation or if Congress enacts a joint resolution terminating the emergency. A national
emergency will terminate automatically upon the anniversary of the proclamation unless the President renews
the proclamation by transmitting notice to Congress and publishing it in the Federal Register.
•

Pets Evacuation and Transportation Standards (PETS) Act of 2006
Pub. L. No. 109-308; 42 U.S.C. §§ 5170(b), 5196, 5196(b)
The PETS Act amends the Stafford Act to require the Federal Emergency Management Agency (FEMA)
Director to ensure that state and local emergency preparedness plans “take into account the needs of
individuals with household pets and service animals prior to, during, and following a major disaster or
emergency.”

•

Homeland Security Presidential Directive 5 (HSPD-5) (February 28, 2003)
HSPD-5 is intended to “enhance the ability of the United States to manage domestic incidents.” The
Directive describes federal policies and objectives; identifies steps for improved coordination among federal,
state, and local authorities; and tasks the Secretary of Homeland Security with developing a National Incident
Management System and National Response Plan.

•

Homeland Security Presidential Directive 8 (HSPD-8) (December 17, 2003)
HSPD-8, as a companion to HSPD-5, “establishes policies to strengthen the preparedness of the United
States to prevent and respond to” man-made and natural disasters and other emergencies. The Directive
requires the Secretary of Homeland Security to develop a national domestic all-hazards preparedness goal,
which establishes “measurable readiness priorities and targets” and “readiness metrics and elements.” The
Directive also requires relevant federal agencies to make financial assistance and support available to states,
support the development of first responder equipment standards, and establish a training program to meet
the national preparedness goals.

•

Emergency Management Assistance Compact (EMAC) of 1996
Pub. L. No. 104-321
EMAC facilitates resource sharing among member states during an emergency. The National Emergency
Management Association (NEMA) administers EMAC, which has been enacted by every state. A governor’s
declaration of emergency and request for assistance triggers EMAC for the requesting state. An assisting state
then responds to the request by providing the needed resources. Further, EMAC establishes that the
requesting state is responsible for compensating the assisting state for any expenses incurred.

Legal Authorities Specific to Public Health Emergencies
•

Section 319 of the Public Health Service Act: Public Health Emergencies
42 U.S.C. § 247d
This section of the Public Health Service Act authorizes the Secretary of the Department of Health and
Human Services (HHS) to determine that a public health emergency exists if “1) a disease or disorder
presents a public health emergency; or 2) a public health emergency, including significant outbreaks of
infectious diseases or bioterrorist attacks, otherwise exists.” From the determination of a public health
emergency flows the ability of the Secretary to “take such action as may be appropriate” and to use funds
from the Public Health Emergency Fund (when appropriated). The public health emergency determination
remains effective until the Secretary either declares that the emergency no longer exists, or at the expiration of
ninety days, whichever occurs first. If the Secretary determines that the same or additional facts continue to
warrant a public health emergency, he or she may renew the declaration for ninety-day periods. As amended
by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, Pub. L. No. 113-5, section 319
also allows the Secretary, upon request by a governor or tribal organization, to authorize the temporary
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reassignment of state and local public health department or agency personnel funded in whole or in part
through programs authorized under the Public Health Service Act for the purpose of immediately addressing
a federally declared public health emergency.
•

Section 311 of the Public Health Service Act: General Grant of Authority for Cooperation
42 U.S.C. § 243
This provision of the Public Health Service Act states that the Secretary of HHS shall assist states and local
authorities in the prevention and suppression of communicable diseases and to help state and local authorities
enforce quarantine regulations. This section also authorizes the Secretary to accept state and local authorities’
assistance with enforcement of federal quarantine regulations. Further, this section authorizes the Secretary to
develop a public health emergency management plan and, at the request of a state or local authority, extend
temporary assistance regarding public health emergencies.

•

Section 319F-2 of the Public Health Service Act: Strategic National Stockpile and Security (the
Stockpile)
42 U.S.C. § 247d-6b; 42 U.S.C. § 300hh-10(c)(3)(b)
The Stockpile (including drugs, vaccines, biological products, medical devices, and other supplies) is
maintained by the Secretary of HHS, in collaboration with CDC’s Director, and in coordination with the
Secretary of Homeland Security, to provide for the emergency health security of the United States. The
Secretary may deploy the Stockpile to respond to an actual or potential public health emergency, protect the
public health or safety, or as required by the Secretary of Homeland Security, respond to an actual or
potential emergency. The responsibility and authority to coordinate the Strategic National Stockpile has been
assigned to the Assistant Secretary for Preparedness and Response under 42 U.S.C. § 300hh-10(c)(3)(b).

•

Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Pub. L. No. 107-188
The Act amends the Public Health Service Act to “improve the ability of the United States to prevent,
prepare for, and respond to bioterrorism and other public health emergencies.” The Act requires the
Secretary of HHS to “develop and implement” a coordinated strategy in the form of a national preparedness
plan. The Act also establishes the position of Assistant Secretary for Public Health Emergency Preparedness
(renamed the Assistant Secretary for Preparedness and Response, see Pandemic and All-Hazards
Preparedness Act below), who is responsible for coordinating the operations of the National Disaster Medical
System and other emergency response activities within HHS. The Act also provides the Secretary of HHS
with the authority to regulate select agents and toxins and to temporarily exempt individuals or entities from
the requirements of these regulations if necessary to provide for a timely response to a public health
emergency. Additionally, several provisions for protection of the food and drug supply are included. Further,
the Act directs the Secretary to establish and maintain the Emergency System for Advance Registration of
Health Professions Volunteers (ESAR-VHP).

•

Pandemic and All-Hazards Preparedness Act of 2006
Pub. L. No. 109-417
The Act identifies the Secretary of HHS as the lead federal official for public health emergency preparedness
and response, and establishes the Assistant Secretary for Preparedness and Response (formerly named the
Assistant Secretary for Public Health Emergency Preparedness, see Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 above). The Act also provides new authorities for developing
countermeasures, establishes mechanisms and grants to continue strengthening state and local public health
security infrastructure, and addresses surge capacity by placing the National Disaster Medical System and the
Emergency System for Advance Registration of Health Professions Volunteers (ESAR-VHP) under the
purview of HHS.

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Pandemic and All–Hazards Preparedness Reauthorization Act (PAHPRA) of 2013
Pub. L. No. 113-5; 42 U.S.C. §§ 247d, 300hh-1(b)(3)(E), 247d-3a(b)(2)(a)(iii), 247d-6d(i)(7)(iii), 21
U.S.C. § 360bbb-3, et seq.
PAHPRA reauthorized funding for provisions of the Pandemic and All-Hazards Preparedness Act of 2006,
as well as amended several provisions of the Public Health Service Act and the Food Drug and Cosmetic Act.
PAHPRA requires Pandemic and All-Hazards Preparedness Act fund recipients to account for children and
“at-risk individuals” in their All-Hazards Public Health Emergency Preparedness and Response Plan, as well
as coordinate with local Metropolitan Medical Response Systems, local Medical Reserve Corps, and the local
Cities Readiness Initiative. Additional PAHPRA changes made to authorities described elsewhere in this
document are contained in the entries addressing
 Section 319 of the Public Health Service Act: Public Health Emergencies;
 The Public Readiness and Emergency Preparedness (PREP) Act of 2005; and
 Emergency Use Authorization.

•

Section 1135 of the Social Security Act: Authority to Waive Requirements During National
Emergencies
42 U.S.C. § 1320b-5
Section 1135 of the Social Security Act authorizes the Secretary of HHS to waive or modify certain
requirements of Medicare, Medicaid, and the State Children's Health Insurance Program during certain
emergencies. Section 1135 waivers require both 1) a declaration of national emergency or disaster by the
President under the National Emergencies Act or the Stafford Act and 2) a public health emergency
determination by the Secretary under the Public Health Service Act. Waivers may be requested by affected
healthcare providers in the emergency area during the emergency period. The Secretary may make a waiver
retroactive to the beginning of the emergency period or any subsequent date thereafter. The waiver generally
expires at the termination of the applicable declaration of emergency or disaster under the National
Emergencies Act or Stafford Act or determination of public health emergency under the Public Health
Service Act. In addition, the Secretary may specify that the waivers terminate sixty days from publication,
which may be extended, provided that neither the original sixty-day period nor any extension extends beyond
termination of the applicable declaration or determination. Waivers related to the Emergency Medical
Treatment and Active Labor Act and the Health Information Portability and Accountability (HIPAA) Privacy
Rule (see below) are subject to different requirements and may terminate after seventy-two hours.

•

Public Readiness and Emergency Preparedness (PREP) Act of 2005
Pub. L. No. 109-148; 42 U.S.C. §§ 247d-6d, 247d-6e
The PREP Act authorizes the Secretary of HHS to issue a declaration that provides immunity from tort
liability for claims of loss (except willful misconduct) caused by, arising out of, relating to, or resulting from
administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to
constitute a present or credible risk of a future public health emergency. The immunity applies to entities and
individuals involved in the development, manufacture, testing, distribution, administration, and use of such
countermeasures. As amended by PAHPRA (see above), the PREP Act immunity explicitly applies to
products or technology intended to enhance medical countermeasures, in addition to the countermeasures
themselves. PAHPRA also extends immunity to countermeasures authorized under sections 564A and 564B
of the Federal Food, Drug, and Cosmetic Act (see below). The Secretary’s declaration includes, among other
things,
 The countermeasures covered by the declaration;
 The category of diseases, health conditions, or health threats for which administration and use of the
countermeasures recommended;
 The effective time period of the declaration;
 The population of individuals receiving the countermeasure;
 Limitations, if any, on the geographic area for which immunity is in effect;
 Limitations, if any, on the means of distribution of the countermeasure; and
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Any additional persons identified by the Secretary as qualified to prescribe, dispense, or administer
the countermeasures.
The Act also authorizes a fund in the United States Treasury to provide compensation for injuries directly
caused by administration or use of the countermeasure covered by the Secretary’s declaration.


•

Emergency Use Authorization
o Section 564 of the Federal Food, Drug, and Cosmetic Act
21 U.S.C. § 360bbb-3
Under section 564 of the Federal Food, Drug, and Cosmetic Act, if
1) The Secretary of HHS has determined that there is a public health emergency or a significant
potential for a public health emergency that affects or may affect national security or the health
of US citizens abroad that involves a chemical, biological, radiological, or nuclear (CBRN) agent
or agents;
2) The Secretary of Homeland Security has determined that there is an actual or significant
potential for a domestic emergency involving a heightened risk of attack with a CBRN agent or
agents;
3) The Secretary of Defense has determined that there is an actual or significant potential for
heightened risk to the military involving a heightened risk of attack with a CBRN agent or
agents; or
4) The Secretary of Homeland Security has identified a material threat pursuant to section 319F-2
of the Public Health Service Act sufficient to affect national security or the health and security of
U.S. citizens abroad that involves a CBRN agent or agents
The Secretary of HHS may, based upon one of the preceding determinations, declare that circumstances
exist to justify an Emergency Use Authorization (EUA) for an unapproved drug, device, or biological
product, or for an unapproved use of an approved drug, device, or biological product. Once an
emergency is declared, the Food and Drug Administration (FDA) Commissioner may issue an EUA for a
particular product or products, assuming other statutory criteria and conditions are met. The EUA
expires when the declaration of emergency terminates or when authorization is revoked. The FDA
Commissioner may impose conditions on the use of the drug or device.
o

Section 564A of the Federal Food, Drug, and Cosmetic Act
21 U.S.C. § 360bbb-3a
Enacted by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (see above),
section 564A established streamlined mechanisms to facilitate certain medical countermeasure
preparedness and response activities without having to issue an EUA (which can be a time- and resourceintensive process). These new authorities, applicable to eligible FDA-approved medical products
intended for use during a chemical, biological, radiological, or nuclear (CBRN) emergency, include
1) Allowing CDC, under delegated authority, to create and issue, and government stakeholders to
disseminate, special emergency use instructions about the FDA-approved conditions of use for
such medical countermeasures before a CBRN event occurs;
2) Permitting the FDA to waive otherwise applicable manufacturing requirements, such as storage
or handling, to accommodate emergency response needs; allowing mass dispensing of medical
countermeasures during an actual CBRN emergency event without requiring an individual
prescription for each recipient of the medical countermeasure, if permitted by State law or if in
accordance with an order issued by the FDA Commissioner; and
3) Expanding the current waiver authority for risk evaluation and mitigation strategies to
encompass any element for medical countermeasures to mitigate the health effects of a CBRN
emergency.

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o

Section 564B of the Federal Food, Drug, and Cosmetic Act
21 U.S.C. § 360bbb-3b
Enacted by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (see above),
section 564B permits federal, state, and local governments to pre-position medical countermeasures in
anticipation of approval or clearance, or issuance of an EUA, enabling them to better prepare for
potential rapid deployment during an actual chemical, biological, radiological, or nuclear emergency.

Public Safety and Security
•

Posse Comitatus Act of 1878
18 U.S.C. § 1385
The Posse Comitatus Act generally prohibits the use of federal military personnel in a law enforcement
capacity within the United States unless authorized by the U.S. Constitution or an act of Congress. Certain
exceptions exist, such as when the Department of Defense aids the Department of Justice in responding to
an emergency situation involving a weapon of mass destruction [10 U.S.C.A. § 382].

•

Insurrection Act of 1807
10 U.S.C. §§ 331-335
The Insurrection Act grants authority to the President to call the National Guard into federal service in the
event of an insurrection in any state or if a state fails to uphold the constitutional rights of its citizens.

•

Emergency Federal Law Enforcement Assistance Act of 2006
42 U.S.C. § 10501, et seq.
Under the Emergency Federal Law Enforcement Assistance Act, the Attorney General may provide law
enforcement assistance, including federal personnel, in response to a governor’s written request, when he or
she determines that such assistance is necessary to provide an adequate response to a law enforcement
emergency. To the extent federal personnel would be used to enforce state or local law, they should be
deputized or otherwise authorized under state or local law to exercise the key law enforcement powers (arrest,
search, seizure) involved in enforcing those laws.

Control of Communicable Diseases
•

Section 311 of the Public Health Service Act: General Grant of Authority for Cooperation
42 U.S.C. § 243
This provision of the Public Health Service Act states that the Secretary of HHS shall assist states and local
authorities in the prevention and suppression of communicable diseases and to help state and local authorities
enforce quarantine regulations. This section also authorizes the Secretary to accept state and local authorities’
assistance with enforcement of federal quarantine regulations. Further, this section authorizes the Secretary to
develop a public health emergency management plan and, at the request of a state or local authority, extend
temporary assistance regarding public health emergencies.

•

Section 361 of the Public Health Service Act: Regulations to Control Communicable Diseases
42 U.S.C. § 264
This section of the Public Health Service Act authorizes the Secretary of HHS to make and enforce
regulations “to prevent the introduction, transmission, or spread of communicable diseases” into the states
and possessions of the United States from foreign countries or possessions or from one state into another.
This section also authorizes the apprehension, detention, examination, and conditional release of individuals
with certain communicable diseases that are specified in an executive order of the President (see Executive
Order 13296, as amended by Executive Order 13375). The process prescribed for isolating or quarantining
such individuals is provided for in 42 C.F.R. Parts 70 and 71 (see below).
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Section 362 of the Public Health Service Act: Suspension of Entries and Imports from Designated
Places to Prevent Spread of Communicable Diseases
42 U.S.C. § 265
This section of the Public Health Service Act authorizes the Secretary of HHS, if he or she determines that a
communicable disease exists in a foreign country and that introduction of persons from this foreign country
poses a serious danger of introducing the disease into the United States, to suspend in the interests of public
health the “introduction of persons” from those foreign countries or places for the time necessary to avert
the danger, in accordance with approved regulations. This provision may also be applied to the introduction
of property (see below).

•

Interstate Quarantine
42 C.F.R. Part 70
These federal regulations allow the CDC Director to take measures to prevent the spread of communicable
diseases from one state or possession into another, including in the event that the Director determines that
the measures taken by the health authorities of a state (including political subdivisions) or possession are
insufficient to prevent such communicable disease spread. These regulations also authorize the detention,
isolation, quarantine, or conditional release of persons for purposes of preventing the interstate spread of
communicable diseases listed in an executive order of the President. See Executive Order 13296, as amended
by Executive Order 13375.

•

Foreign Quarantine
42 C.F.R. Part 71
These federal regulations allow the CDC Director to take measures to prevent the introduction, transmission,
and spread of communicable diseases into the United States from foreign countries. Among other things, the
regulations require the commander of an aircraft or master of a ship destined for a U.S. port to report the
occurrence of any deaths or ill persons onboard to the nearest quarantine station. These regulations also
authorize the Director to inspect and detain ships and planes arriving into the United States as may be
necessary to prevent the spread of communicable diseases, as well as regulate the importation of infectious
biological agents, infectious substances, and vectors. The Director may also isolate, quarantine, or place
arriving persons under public health surveillance whenever the Director reasonably believes that the person is
infected with or has been exposed to any of the communicable disease listed in an executive order of the
President. See Executive Order 13296, as amended by Executive Order 13375.

•

Executive Order 13295: Revised List of Quarantinable Communicable Diseases (April 4, 2003)
This Executive Order identifies the eight communicable diseases (cholera; diphtheria; infectious tuberculosis;
plague; smallpox; yellow fever; viral hemorrhagic fevers; and Severe Acute Respiratory Syndrome (SARS)), for
which an individual can be apprehended, detained, examined, or conditionally released by federal public
health authorities under 42 C.F.R.. §§ 70 and 71.

•

Executive Order 13375: Amendment to Executive Order 13295 Relating to Certain Influenza Viruses
and Quarantinable Communicable Diseases (April 1, 2005)
This Executive Order amends Executive Order 13295 by adding “influenza caused by novel or reemergent
influenza viruses that are causing, or have the potential to cause, a pandemic” to the list of communicable
diseases for which an individual can be apprehended, detained, examined, or conditionally released by federal
public health authorities under 42 C.F.R.. §§ 70 and 71.

•

Executive Order 13674: Amendment to Executive Order 13295 Revised List of Quarantinable
Communicable Diseases (July 31, 2014)
This Executive Order amends Executive Orders 13295 and 13375 by updating the reference to Severe Acute
Respiratory Syndrome on the list of communicable diseases for which an individual can be apprehended,
detained, examined, or conditionally released by federal public health authorities under 42 C.F.R. §§ 70 and 71
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to read as follows: “Severe acute respiratory syndromes, which are diseases that are associated with fever and
signs and symptoms of pneumonia or other respiratory illness, are capable of being transmitted from person
to person, and that either are causing, or have the potential to cause, a pandemic, or, upon infection, are
highly likely to cause mortality or serious morbidity if not properly controlled.”
•

Penalties for Violation of Quarantine Law
42 U.S.C. § 271
This statutory provision states that violation of federal quarantine regulations is a crime punishable by a fine
of not more $1,000 or by imprisonment for not more than one year, or both. Implementing regulations are
found at 42 C.F.R. Part 71.2. These penalties are strengthened under the sentencing classification provisions
of 18 U.S.C. §§ 3559 and 3571, which provide for more strict penalties for criminal violations that would
otherwise be classified as Class A misdemeanors. Under these strengthened penalties, individuals may be
punished by a fine of up to $100,000 per violation not resulting in the death of an individual, or up to
$250,000 per violation resulting in the death of an individual [18 U.S.C. 3559, 3571(b)]. Organizations may be
fined up to $200,000 per violation not resulting in the death of an individual and $500,000 per violation
resulting in the death of an individual [18 U.S.C. 3559, 3571(c)].

•

Emergency Medical Treatment and Active Labor Act (EMTALA)
42 U.S.C. § 1395dd
EMTALA requires that hospitals accepting Medicare payments provide patients coming to the emergency
department appropriate medical screening for emergency medical conditions without regard to citizenship,
legal status, or ability to pay. If the patient is found to have an emergency medical condition, the hospital
must either provide further examination and treatment until the patient is stabilized, or, if the hospital is
unable to stabilize the patient, the hospital must arrange for transfer of the individual to a capable facility.
Patients cannot be denied stabilizing treatment or discharged prematurely based on prior unpaid debts to the
hospital. While patients cannot be held criminally liable, hospitals may seek judgments against non-paying
patients in civil court for the amounts owed.

•

State Health Laws Observed by United States Officers
42 U.S.C. § 97
This provision states that U.S. Coast Guard and customs officers, as well as “military officers commanding in
any fort or station upon the seacoast,” shall observe quarantines and health laws imposed by states regarding
the arrival of vessels, and according to their respective powers, aid in the execution of such state health laws
and quarantines as directed from time to time by the Secretary of HHS.

•

Quarantine Duties of Consular and Other Officers
42 U.S.C. § 268(b)
These statutes state the duty of Customs and Border Protection and the U.S. Coast Guard to aid in the
execution of federal quarantine and the enforcement of federal quarantine rules and regulations.

•

Immigration Authority
8 U.S.C. §§ 1182 and 1222, 42 U.S.C. § 252
Under these provisions, the Department of Homeland Security and HHS are charged with conducting
physical and mental examinations of arriving aliens. Under 8 U.S.C. § 1182, aliens are inadmissible in to the
United States on health-related grounds if determined to have a communicable disease of public health
significance, certain mental or physical defects, to be a drug abuser or addict, or to have failed to present
documentation of vaccination against vaccine-preventable diseases as set forth in the statute. The process that
HHS prescribes for conducting the medical examinations is provided for in 42 C.F.R. Part 34 (see below).

•

Medical Examination of Aliens
42 C.F.R. Part 34
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CDC administers this regulation, which describes and specifies the medical examination criteria that aliens
must undergo before they may be admitted to the United States. The medical examination applies to aliens
outside the U.S. applying for an immigrant visa; aliens arriving in the U.S.; aliens required by DHS to have a
medical examination; and applicants in the U.S. applying for adjustment of their immigration status to that of
permanent legal resident. Aliens determined to have a communicable disease of public health significance are
generally inadmissible unless granted a waiver by DHS.

Managing Transportation
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Transportation Security Administration Authority to Cancel or Ground Flights
49 U.S.C. §§ 114 and 44905(b)
The Transportation Security Administration has the authority to cancel a flight or prevent planes from
landing if “a decision is made that a particular threat cannot be addressed in a way adequate to ensure, to the
extent feasible, the safety of passengers and crew of a particular flight or series of flights.”

•

Federal Aviation Administration Authority to Restrict Airport Access or Airspace
49 U.S.C. §§ 40101(d), 40103(b), 44701, and 46105(c)
The Federal Aviation Administration (FAA) has authority to stop, redirect, or exclude flights in United States
airspace for public safety and has the authority to restrict airport access due to emergency conditions on the
ground. If the FAA Administrator believes it necessary, he or she may “prescribe regulations and issue orders
immediately to meet the emergency.”

Managing Animals, Food, and Other Property
•

Control of Communicable Diseases
21 C.F.R. Part 1240
Similar to the regulations governing interstate quarantine, these regulations allow the FDA Commissioner to
take measures to prevent the spread of communicable diseases from one state or possession into another in
the event that the Commissioner determines that the measures taken by the health authorities of a state
(including political subdivisions) or possession are insufficient to prevent such communicable disease spread.
These regulations also govern the interstate transport of mollusks, milk, turtles, certain birds, garbage, and
drinking water.

•

Foreign Quarantine
42 C.F.R. Part 71
In addition to allowing the CDC Director to take measures to prevent the introduction, transmission, and
spread of communicable diseases into the United States from foreign countries, by regulating the entry of
people into the United States, these regulations also govern the importation of certain animals, including
dogs, cats, turtles, and nonhuman primates, as well as regulate the importation of infectious biological agents,
infectious substances, and vectors.

•

Section 361 of the Public Health Service Act: Regulations to Control Communicable Diseases
42 U.S.C. § 264
For purposes of carrying out and enforcing regulations enacted under section 361 of the Public Health
Service Act, this section states that the Secretary of HHS “may provide for such inspection, fumigation,
disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or
contaminated as to be sources of dangerous infection to human beings . . .”

•

Section 362 of the Public Health Service Act: Suspension of Entries and Imports from Designated
Places to Prevent Spread of Communicable Diseases
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42 U.S.C. § 265
This section of the Public Health Service Act authorizes the Secretary of HHS, if he or she determines that a
communicable disease exists in a foreign country and that introduction of property from this foreign country
poses a serious danger of introducing the disease into the United States, to suspend in the interests of public
health the “introduction of property” from those foreign countries or places for the time necessary to avert
the danger, in accordance with approved regulations.
•

Pets Evacuation and Transportation Standards (PETS) Act of 2006
Pub. L. No. 109-308; 42 U.S.C. §§ 5170(b), 5196, 5196(b)
The PETS Act amends the Stafford Act to require the FEMA Director to ensure that state and local
emergency preparedness plans “take into account the needs of individuals with household pets and service
animals prior to, during, and following a major disaster or emergency.”

Liability, Workers’ Compensation, and Licensure
•

Federal Tort Claims Act
28 U.S.C. §§ 1346(b), 2671–2680
The Act waives the doctrine of sovereign immunity so that the United States can be held liable for the
negligent acts or omissions of federal employees committed within the scope of their federal employment.
Claims based on discretionary functions or intentional torts are explicitly precluded. Further, suits by military
personnel for injuries sustained during service (also known as the Feres doctrine) have been deemed by the
courts as outside of the Act. To proceed against the United States, the Attorney General must certify that the
federal employee was acting within the scope of his office or employment, or, if the Attorney General refuses,
the employee may petition the court to make this finding and certify. Once certified, the United States
replaces the employee as the party defendant in the suit.

•

Federal Employee Compensation Act of 1993
Pub. L. No. 103-3; 5 U.S.C. § 81
The Federal Employee Compensation Act provides workers’ compensation to civilian federal employees
injured or killed while performing their duties. An injured employee or the family of an employee killed while
performing his duties is entitled to related medical services and benefits unless the employee intended to
bring about the injury or death, caused the injury or death through the employee’s own willful misconduct, or
the injury or death was proximately caused by the employee’s intoxication.

•

Public Readiness and Emergency Preparedness (PREP) Act of 2005
Pub. L. No. 109-148; 42 U.S.C. §§ 247d-6d, 247d-6e
The PREP Act authorizes the Secretary of HHS to issue a declaration that provides immunity from tort
liability for claims of loss (except willful misconduct) caused by, arising out of, relating to, or resulting from
administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to
constitute a present, or credible risk of a future public health emergency. The immunity applies to entities and
individuals involved in the development, manufacture, testing, distribution, administration, and use of such
countermeasures. As amended by PAHPRA (see above), PREP Act immunity also explicitly applies to
products or technology intended to enhance medical countermeasures, in addition to the countermeasures
themselves (see Pandemic and All–Hazards Preparedness Reauthorization Act (PAHPRA) of 2013 above).
PAHPRA also extends immunity to countermeasures authorized under sections 564A and 564B of the
Federal Food, Drug, and Cosmetic Act (see above). The Secretary’s declaration includes, among other things,
the countermeasures covered by the declaration; the category of diseases, health conditions, or health threats
for which administration and use of the countermeasures recommended; the effective time period of the
declaration; the population of individuals receiving the countermeasure; limitations, if any, on the geographic
area for which immunity is in effect; limitations, if any, on the means of distribution of the countermeasure;
and any additional persons identified by the Secretary as qualified to prescribe, dispense, or administer the
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countermeasures. The Act also authorizes a fund in the United States Treasury to provide compensation for
injuries directly caused by administration or use of the countermeasure covered by the Secretary’s declaration.
•

Volunteer Protection Act of 1997
Pub. L. No 105-295; 42 U.S.C. §§ 14501–14505
The Volunteer Protection Act supports and promotes the activities of organizations that rely on volunteers
by providing the volunteers some protections from liability for economic damages for activities relating to the
work of the organizations. Under the Act, to be found not liable for the injury caused by a negligent act or
omission of the volunteer, the volunteer must have been acting within the scope of his or her responsibilities
in the nonprofit or government agency. The volunteer must have appropriate licensure or certification if
required for the volunteer’s duties; he or she must not have acted with gross negligence, reckless disregard,
willful or criminal misconduct, or flagrant indifference; and the injury cannot have occurred while the
volunteer was intoxicated. Further, the injury cannot have occurred while the volunteer was operating an
automobile or other vehicle for which the state requires an operator’s license and insurance. This Act does
not limit the liability of the nonprofit or government agency. The Act does not limit an injured party’s ability
to sue for non-economic damages, provide immunity to the non-profit organization or government entity
supervising the volunteer, nor limit a nonprofit or government entity’s ability to bring a civil action against
the volunteer. States may opt out of the Volunteer Protection Act.

•

Emergency Management Assistance Compact (EMAC) of 1996
Pub. L. No. 104-321
EMAC facilitates resource sharing among member states during an emergency. The National Emergency
Management Association (NEMA) administers EMAC, which has been enacted by every state. A governor’s
declaration of emergency and request for assistance triggers EMAC for the requesting state. An assisting state
then responds to the request by providing the needed resources, including personnel. EMAC stipulates that a
provider who is licensed or certified in one state will be considered licensed or certified in the receiving state
subject to limitations described in the requesting state’s governor’s order. EMAC provides for protection of
officers or employees of the assisting state from tort liability for negligent acts or omissions unless the officer
or employee acted with gross negligence, recklessness, or willful misconduct. EMAC also requires that each
state provide for worker’s compensation in instances of injury or death for their own employees.

Personal Health Information and Privacy
•

Privacy Act of 1974
5 U.S.C. § 552a
The Privacy Act describes the fair collection, maintenance, use and dissemination by a government agency of
records containing personal identifiers (i.e. name, social security number, date of birth, etc.). Generally, the
Act requires that information compiled in a federal record for a specific individual may not be used for
another purpose without consent of the individual. The Act prevents disclosure of information contained in
the record without an individual’s written consent, unless the disclosure is one of the twelve exceptions
expressly stated within the Act. Under most circumstances, individuals are allowed to request access to their
own records and to challenge inaccurate information. The Act also outlines the civil remedies available if a
government agency makes an unauthorized disclosure of an individual’s personal information.

•

Health Information Portability and Accountability Act (HIPAA) of 1996: Privacy Rule
Pub. L. No. 104-191
The HIPAA Privacy Rule protects certain patient information (including health insurance and billing
information, medical records, and conversations with providers) from being disclosed by covered entities
(including most health insurance companies, health care providers, and health information clearinghouses) for
reasons other than providing treatment and care, billing and payment, protecting the public’s health (such as
through surveillance of specific diseases), or reporting required information to police (such as gunshot
wounds). Information cannot be disclosed outside of the HIPAA provisions without the patient’s express
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written permission. Covered entities must have safeguards in place to protect patient health information to
ensure that it is not mishandled. If a Section 319 Emergency has been declared, the Secretary of HHS may
waive certain sanctions for non-compliance with HIPAA. Note that CDC is not a covered entity under
HIPAA, nor are state or local public health departments unless they also treat patients. Regulations are found
at 34 C.F.R. Part 160 and Subparts A and E of 164.
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Family Educational Rights and Privacy Act (FERPA) of 1973
Pub. L. No. 93- 380, as amended; 20 U.S.C. § 1232g
FERPA applies to all educational agencies and institutions receiving funds under any program from the
United States Department of Education, which encompasses virtually all public schools and universities, as
well as some private schools. The school or agency may not disclose student records without a parent’s or
eligible student’s written consent (an eligible student is either eighteen years or older or is attending a postsecondary institution at any age). FERPA also gives parents and eligible students the right to access and
review records. Parents and eligible students may request explanation of items in the record, seek amendment
to records for information that is “inaccurate, misleading, or in violation of the student’s privacy” and may
request a hearing to challenge the content of the record if the school or agency does not agree to the
amendment. Disclosure to teachers and other relevant employees of the school or agency without consent of
the parent or eligible child is allowed for legitimate educational purposes; disclosure without consent is also
allowed in several express purposes, including “in connection with an emergency if knowledge of the
information is necessary to protect the health or safety of the student or other individuals.” For this
exception, the school or agency must make a determination that there is an “articulable and significant threat”
to the health and safety of the student or other individuals, taking into consideration a totality of the
circumstances. Regulations are found at 34 C.F.R. Part 99.

Related Federal Guidance
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National Response Framework (January 2008; updated May 2013)
The National Response Framework is a guide to how the United States conducts all-hazards response, and is
intended to capture specific authorities and best practices for managing incidents that range from the serious
but purely local, to large-scale terrorist attacks or catastrophic natural disasters. In addition to the core
document, the framework contains Emergency Support Function (ESF) Annexes which group federal
resources and capabilities into functional areas to serve as the primary mechanisms for providing assistance at
the operational level. Common roles of federal agencies during emergencies are grouped together into fifteen
ESFs with different responsibilities based on these roles. Within each ESF, there is at least one primary
agency, support agencies, and an ESF coordinator that is selected to oversee the ESF.
 ESF #8 is designated for Public Health and Medical Services. The U.S. Department of Health and
Human Services (HHS) is the Primary Agency and Coordinator for ESF #8. ESF #8 outlines the
roles of the Primary Agency and each Supporting Agency when providing assistance to state, tribal,
and local governments during public health emergencies or threats.
 ESF#13 is designated for Public Safety and Security. The U.S. Department of Justice is the Primary
Agency and Coordinator for ESF#13. This ESF is activated in situations requiring extensive public
safety and security and where state, tribal, and local government resources are overwhelmed or are
inadequate or for federal-to-federal support.
The Framework also contains Incident Annexes that describe the concept of operations to address specific
contingency or hazard situations or an element of an incident requiring specialized application of the
Framework. The Biological Incident Annex outlines the actions, roles, and responsibilities associated with a
human disease outbreak of known or unknown origin requiring federal assistance. HHS is the coordinating
agency for this annex. The Food and Agriculture Incident Annex describes the roles and responsibilities
associated with incidents involving agriculture and food systems that require a coordinated federal response.
Both HHS and the Department of Agriculture are the coordinating agencies for this annex.
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