Regulatory Procedures Manual

JULY 2018

CHAPTER 8 – Emergency Procedures

7/20/2018 8-18-1

This chapter contains the following sections.

Section Topic Page

8-1 PURPOSE............................................................................................................. 2

8-2 INTRODUCTION................................................................................................... 2

8-2-1 Procedures ..................................................................................................... 2

8-3 RESPONSIBILITY ................................................................................................ 4

8-3-1 General........................................................................................................... 4

8-3-2 Declaring an Emergency................................................................................. 4

8-4 NOTIFICATION OF EMERGENCIES: TERMINOLOGY....................................... 4

8-4-1 Alert ................................................................................................................ 5

8-4-2 Presumptive.................................................................................................... 5

8-4-3 Confirmed ....................................................................................................... 5

8-5 TERMINATION OF EMERGENCY INVESTIGATION........................................... 5

8-6 OPERATING PROCEDURE ................................................................................. 6

8-6-1 24-Hour Communications System .................................................................. 6

8-6-2 Emergency Alerts............................................................................................ 6

8-6-3 Investigational Instructions.............................................................................. 7

8-6-4 Emergency Management................................................................................ 7

8-6-5 Reporting ........................................................................................................ 9

8-7 HEADQUARTERS OPERATING PROCEDURES.............................................. 11

8-7-1 FDA Emergency Operations Center ............................................................. 11

8-7-2 Center Emergency Coordination Units.......................................................... 13

8-7-3 Office of Regulatory Affairs ........................................................................... 13

8-7-4 Office of Partnerships (OP)........................................................................... 14

8-8 INTERAGENCY COORDINATION ..................................................................... 15

8-8-1 Agencies FDA Cooperates With In Emergency Situations............................ 15

8-8-2 Federal Agency Checklist ............................................................................. 15
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-2

8-8-3 State and Local Agency Checklist................................................................. 17

8-9 PRESS RELATIONS........................................................................................... 17

8-9-1 Notification of the Office of Media Affairs (OMA)........................................... 17

8-10 REFERENCES.................................................................................................... 18

8-10-1 General references.................................................................................... 18

8-10-2 Specific references .................................................................................... 18

8-11 Attachment A - Guidelines for Follow-up of Tampering ................................ 19

All questions pertaining to this chapter should be directed to the FDA Office of 

Emergency Operations Office of Emergency Operations (OEO), Office of Emergency 

Management, Emergency Operations Center (EOC), 866-300-4374 (24-hour number).

See SMG 1117.621 for more information on OEO.

FDA’s Emergency Operations Plan is the detailed document that should be followed in 

an emergency. See Emergency Preparedness > Emergency Response on FDA.gov.

8-1 PURPOSE

To set forth emergency management procedures for the FDA's 

headquarters and personnel resulting from Executive Order 12656, 

various Presidential Decision Documents, the Stafford Disaster Relief and 

Emergency Assistance Act, and the National Response Framework.

8-2 INTRODUCTION

8-2-1 Procedures

These procedures provide guidance for the Agency to act immediately to 

protect the public from contaminated or defective FDA-regulated products 

or in situations when FDA-regulated products need to be utilized or 

deployed. Prompt emergency actions are dependent upon the expeditious 

reporting and investigation of significant incidents or complaints relating to 

FDA-regulated products. Examples of such incidents include chemical and 

biological terrorism, chemical spills affecting food and animal feed 

supplies, natural disasters, radiological incidents, and food-borne illness 

outbreaks.

The emergency alert system, which is a part of this procedure, directs 

telephone notification to the EOC, Office of Crisis Management, Office of 

the Commissioner. This alert system utilizes information from many 

internal FDA sources (e.g., systems to report consumer complaints, 

adverse reactions, product defects, radiological release, and other 

surveillance reporting systems). The EOC also receives information from 

outside sources, including other federal or state agencies, foreign health 

officials, industry and the press.
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-3

The FDA conducts response operations under the Incident Command 

System (ICS) of the National Incident Management System 

Implementation. The EOC coordinates the FDA response to emergency 

situations by facilitating rapid and early information sharing as well as by 

providing real-time situational awareness to and from FDA headquarters, 

centers, and offices. The EOC is supported by a multi-level network of 

over 40 offices in FDA headquarters, centers, programs, and divisions.

A. Definition of Emergency

For the purpose of this procedure, the following definition of 

"emergency” shall apply:

An unforeseen occurrence or a combination of circumstances that 

poses a significant risk to public health, and that involves the 

safety, efficacy, and security of human and veterinary medicines, 

biological products, medical devices, food supply, cosmetics, 

products that emit radiation, or tobacco products, and that calls for 

immediate actions by FDA staff.

B. Scope of Incidents

This procedure was developed to provide guidance for planning, 

monitoring, coordinating, and directing FDA response to situations 

which include, but are not limited to:

1. National emergencies (e.g., civil disorders, major transportation 

and industrial strikes, acts of terrorism, refugee crises, etc.);

2. Natural disasters (e.g., hurricanes, floods, earthquakes,

tornadoes, volcanic eruptions, etc.);

3. Man-made disasters (e.g., radiological incidents, chemical spills,

toxic waste problems, air pollution problems, technological 

incidents and associated threats, etc.);

4. Injury and illness complaints or reports of tampering (e.g., foods,

drugs, biologics, cosmetics, medical devices, and radiation 

emitting devices, veterinary products;

5. Epidemiological investigations (e.g., illness outbreaks 

associated with foodborne or other pathogens and adverse 

reactions, etc.); and,

6. Agency emergency preparedness (e.g., planning, development, 

implementation, and testing of emergency preparedness plans 

in response to attack).

C. Relationship to Recalls

Product recalls may occur during an emergency investigation; if so, 

procedures under Chapter 7 of the Regulatory Procedures Manual

(RPM) should be followed as well. A recall that is for a defective 

product and that is progressing satisfactorily will not by itself activate 

this emergency procedure.
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-4

8-3 RESPONSIBILITY

8-3-1 General

Alerts to potential emergencies are nearly an everyday occurrence at 

FDA. The Agency's permanent organizational structure is designed, in 

part, to accommodate both large and small emergencies. In an emergency 

situation, it is important that individual assignments and responsibilities be 

consistent with normal functions and duties as outlined in unit functional 

statements and position descriptions.

The EOC is a focal point for the review of preliminary information about 

potential emergencies and the EOC assists in the early recognition of 

incidents, outbreaks and potential acts of terrorism. Primary responsibility 

for monitoring emergency alert information and coordinating investigations 

and scientific evaluations rests with the EOC. For any emergencies 

involving highly transmissible diseases such as Severe Acute Respiratory 

Syndrome (SARS), highly pathogenic avian influenza, West Nile Virus

(WNV), malaria, etc., and for chemical, biological or radiological 

emergencies, staff should contact the EOC by email at 

Emergency.Operations@fda.hhs.gov or by phone at 866-300-4374.

8-3-2 Declaring an Emergency

This procedure includes mechanisms for monitoring investigations before 

making a determination that an emergency exists. It is expected that the 

involved centers and division offices will establish the coordination units 

discussed in this procedure during the course of an investigation as the 

situation warrants. In some instances, a formal declaration of an 

emergency may be required in order to activate the appropriate 

emergency coordinating units within the Agency. On other occasions, a 

formal declaration of an emergency may not be required because all 

coordination units are already functioning.

If there is disagreement among offices or if there is uncertainty regarding 

whether or not FDA should initiate emergency action under this procedure, 

the issue should immediately (by telephone) be referred to the Office of 

Crisis Management/EOC. See Chapter 8-6-3 Investigational Instructions.

The Director, Office of Crisis Management along with the Associate 

Commissioner for Regulatory Affairs (ACRA) or designee, in consultation 

with ORA offices and the involved centers, will decide whether to 

implement the procedure and will notify the appropriate offices.

8-4 NOTIFICATION OF EMERGENCIES: TERMINOLOGY

The terms below (e.g., alert, case, suspect, preliminary, etc.) will be used 

in providing notification and describing the status of a sample analysis or 

the stage of an investigation. This consistent terminology can prevent 

confusion and misinterpretation in the identification and management of 

emergency situations.
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-5

8-4-1 Alert

Information without support: An alert should be made when the following 

type of information is received:

A. An unconfirmed report of product related illness/injury or unanticipated 

adverse reaction;

B. An unconfirmed report of the presence of a toxic (e.g., chemical, 

radioactive, or microbial) substance;

C. A report of a man-made disaster (e.g., oil spill, radiological accident) or 

a natural disaster (e.g., hurricane, flood, tornado);

D. Confirmation of a declaration of pandemic influenza (e.g., WHO

Phases 4, 5, and 6; US Government Response Stages 2, 3, 4, and 5).

8-4-2 Presumptive

Information (analytical, inspectional, investigational, etc.) strongly 

suggests that a problem exists. Presumptive may be used to describe 

situations that include:

A. Epidemiological data has provided a significant association between 

the illness, injury, or unanticipated adverse reactions and the product;

B. An original analysis by a reliable laboratory has revealed a significant 

level of a toxic chemical, radioactive material, or microbial substance in 

a regulated product, but confirmation is not complete;

C. An oil spill has drifted into fishing areas;

D. A radiological incident has occurred and radioactive material has been 

released, but the extent is unknown;

E. Floods have caused property damage in an area where regulated 

products are being held; or

F. Confirmation of widespread outbreak of a novel strain of influenza in 

multiple locations overseas (e.g., WHO Phase 6; US Government 

Response Stage 3).

8-4-3 Confirmed

A problem has been confirmed through laboratory analyses,

investigations, analysis of epidemiological data or a combination of these. 

Information received from another governmental agency or other source 

known to be reliable may be accepted for confirmation purposes. An 

example would be when the first human case of pandemic influenza in 

U.S. is confirmed (WHO Phase 6; US Government Response Stage 4).

8-5 TERMINATION OF EMERGENCY INVESTIGATION

When it is not possible to obtain information confirming that an emergency 

situation exists, emergency investigations may be terminated at the Alert 
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-6

or the Presumptive stages. However, in all cases, the EOC will attempt to 

identify the source and scope of the problem, and the hazard involved.

The depth and extent of FDA activities, at the confirmation of an 

emergency situation, is based on factors such as:

A. Interstate distribution of involved product, and,

B. Other Federal, state, or local government efforts to control the 

problem.

When other Federal, state, or local agencies can deal more effectively 

with a problem, FDA will terminate its emergency investigation, at which 

time ad hoc emergency teams or units established under this procedure 

may be phased out by the EOC. The investigating agency should maintain 

contact with the EOC until a conclusion is reached. Likewise, following 

completion of an FDA emergency investigation, ad hoc emergency teams 

or units established under this procedure may be phased out after 

consultation with the EOC.

8-6 OPERATING PROCEDURE

8-6-1 24-Hour Communications System

Each program and division office will maintain a means by which 

headquarters can communicate emergency situations on a 24-hour, 7-

days-a-week basis. Each designated contact, including an after hours

phone number, should be identified to the EOC. Changes in contact points 

should be reported in a timely manner to the EOC. Each program and 

division will establish and maintain procedures for internal 

communications and will provide for appropriate liaison and notification 

systems to city, county, and state governments, and to local offices of 

Federal agencies.

8-6-2 Emergency Alerts

All reports of natural or man-made disasters and significant alleged or 

actual adverse effects associated with FDA-regulated products require 

prompt reporting to the EOC by phone, but e-mail, fax, text, or other 

available communication methods will be acceptable if telephones are not 

available. Confirmatory or summary reports may be forwarded by Email to

Emergency.Operations@fda.hhs.gov . 

A. Report the nature and effect of the emergency including as much of 

the following information as is available:

1. Product description, e.g., product name (proprietary and 

generic), dosage form (tablet, injectable, suspension, etc.), 

strength, expiration date, size and type of package,

manufacturer, lot number, and product code; 

2. Probable or actual distribution pattern, e.g., state or nationwide;
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-7

3. Description of product-related illnesses or injuries, including 

symptoms, onset times, and duration; where applicable, include 

name, address, age, sex of affected parties, and identify 

hospital and medical personnel that are involved, including 

telephone numbers;

4. Steps taken to coordinate FDA actions with state, local and 

other Federal officials; also, any independent actions taken by 

state and/or local officials; and

5. Actions taken by firms to mitigate risk including corrective 

actions, recalls, public outreach or media coverage.

B. In addition to the above, disasters related to fires, high winds, floods, 

wrecks, explosions, strikes, civil disorders, covert actions, pandemic 

influenza, radiological incidents, etc., also require the reporting of:

1. The magnitude of health hazards or other problems related to 

FDA activities; and

2. The extent to which FDA facilities are or may be affected.

8-6-3 Investigational Instructions

Refer to IOM, Chapter 8 — Investigations for detailed investigative 

procedures.

8-6-4 Emergency Management

A. Coordination with the EOC

The EOC will be the focal point for all emergency coordination between 

the division(s) involved, the center(s) involved, HQ offices, and other 

federal, state and local agencies. A member of the EOC staff will be 

designated to oversee each emergency situation. However, all EOC 

staff members are kept abreast of the situation and should be able to 

serve as a backup as necessary.

Other offices and agencies involved in an emergency situation will 

identify a contact for all communications.

B. Lead Office

As FDA conducts response operations under ICS, the office in which 

the emergency is occurring (e.g., where people are becoming ill or 

where a disaster has occurred) will assume the lead investigative role 

in determining the cause of the emergency, managing on-scene 

operations, and obtaining necessary information for the Agency to 

confirm the health hazard. This lead would generally be the division, 

but may be the program.

If it becomes apparent during the course of the investigation that a firm 

in another division is responsible for the product involved in the 

emergency, the lead division designation will be transferred to the 

home division of the responsible firm.
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-8

Any change in the designation of lead division should be concurred 

with by the EOC. In certain widespread emergencies involving more 

than one responsible firm, the EOC may assume the lead role without 

designation of a lead division.

The lead division will identify an ad hoc emergency management team 

to be headed by the division director or a designated division person 

and a coordinator. The exact number and mix of persons on the team 

will be determined by the division Any recommendations for 

reallocation of staff between or among divisions during emergencies 

should be directed to the Office of Operations (OO).

C. Office Emergency Coordinator

A senior staff employee should be promptly named as coordinator of 

the emergency response activities. This person should generally be 

located at the lead division office to facilitate communication and 

review of records. In a widespread emergency, additional coordinators 

may be named by the involved division as necessary. The coordinator 

will be responsible for advising management of actions needed to 

follow-up on the emergency and for channeling all necessary 

communications.

D. Any or all of the following steps should be included:

1. Investigation/Analysis

2. Issuing assignments to division personnel to obtain the 

information necessary for Agency personnel to evaluate the 

health hazard of the situation;

3. Monitoring assignments to assure timely completion;

4. Arranging for continuing contact with investigators for flow of 

information;

5. Seeking technical guidance through the EOC relating to the 

investigation, samples needed, etc.;

6. Determining in consultation with the Office of Regulatory 

Science, ORA the appropriate laboratory for submitting 

samples; and

7. Alerting that laboratory as soon as possible so that necessary 

preparations may be made.

E. Maintaining Communications

1. Keeping appropriate division and program management 

informed of investigational and analytical progress;

2. Preparing daily status reports;

3. Contacting the appropriate state and local authorities already 

involved with the investigation; and,
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-9

4. Serving as a local FDA press contact concerning the 

emergency, working with headquarters in preparing statements 

to the press.

NOTE: FDA employees may be asked by media or other outside 

organizations to respond to inquiries about ongoing investigations 

when the employees are not in a position to first seek guidance from 

the Office of Media Affairs (OMA). Such employees must assess these 

situations and the media requests on an individual basis and respond 

appropriately. When possible, media requests should be referred to 

first line supervisors or above. Unless specifically authorized to do so, 

only those employees whose position descriptions include 

communications with the press should provide statements to the press.

See 8-9, Press Relations.

Care must be taken to ensure that timely, accurate, complete and 

authorized information is issued.

Significant emergency press coverage should be reported to the EOC 

promptly. The EOC will notify the Office of the Commissioner, Office of 

Communications and Quality Program Management (OCQPM), Office 

of Partnerships (OP), and other offices of the press coverage. Copies 

of local press releases by the state and/or the firm should be sent to 

EOC at Emergency.Operations@fda.hhs.gov as soon as possible.

F. Documentation

1. A chronology of the emergency situation should be kept, starting 

with the original alert. It should be updated frequently since this 

information is often needed on short notice by Agency or 

Department personnel.

2. Significant telephone conversations involving the emergency 

should be documented by the participants and forwarded to the 

EOC daily.

3. Statistical data such as numbers of samples analyzed, 

inspections made, injuries reported, farms quarantined, etc., 

should begin early in the process and should be maintained.

G. Command Post Location

The FDA lead division office facility should generally serve as the site 

of FDA's command post because of the available communications 

equipment. If the emergency is in a state without a well- equipped FDA 

office, consideration may be given to locating FDA's command post at 

the cooperating lead state agency.

8-6-5 Reporting

A. Status Report

During the height of an emergency, the division’s emergency 

coordinator should forward daily status reports to the EOC by e-mail to

Emergency.Operations@fda.hhs.gov, with a copy to the responsible 
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-10

emergency coordination unit for the center(s). Copies of such reports 

should also be forwarded to the lead division(s) (see 8-6-3

Investigational Instructions) by all investigating divisions. The EOC will 

specify when status reports are needed less frequently. Status reports 

should be in bullet format, highlighting significant information 

concerning the emergency (e.g., investigations, analyses, public 

affairs, cooperating agencies, scientific, and court matters).

The EOC will facilitate contact between divisions with the appropriate 

center coordinator.

B. Hard Copy Reports

The division's emergency coordinator should forward copies of all 

reports pertaining to the initial alert and subsequent investigation to the 

responsible center(s) and to the EOC. Each submission must include 

product name and product code to enable proper filing by the EOC. 

Copies of complaint reports, memos, collection reports, establishment 

inspection reports, reports of analyses, follow-up investigations, 

recommendations for regulatory action and recalls, when generated by 

an emergency, should be submitted. Unless a specific center office is 

identified to receive hard copy, hard copy reporting to the centers for 

emergencies is as follows:

1. Center for Food Safety and Applied Nutrition:

Center for Food Safety and Applied Nutrition

Office of Analytics and Outreach 

Supervisor, Emergency Coordination and Response Team

5100 Paint Branch Parkway, Room 2B-014

College Park, MD 20740-3835

2. Center for Drug Evaluation and Research:

Counter-Terrorism & Emergency Coordination Staff (CTECS)

10001 New Hampshire Avenue, Room 2155

Silver Spring, MD 20993-1707

3. Center for Biologics Evaluation and Research:

Center for Biologics Evaluation and Research

Office of Compliance and Biologics Quality 

Division of Inspections and Surveillance

10903 New Hampshire Avenue

Building 71, Room 5141

Silver Spring, MD 20993

4. Center for Devices and Radiological Health

For all reports:

Center for Devices and Radiological Health

Office of Compliance

10903 New Hampshire Avenue

Building 66, Room 2621

Silver Spring, MD 20993
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-11

For reports of incidents involving radiation or radioactive 

material releases:

Center for Devices and Radiological Health

Office of Communication, Education and Radiation 

Programs

Division of Mammography Quality and Radiation Programs

10903 New Hampshire Avenue

Building 66, Room 0609

Silver Spring, MD 20993

5. Center for Veterinary Medicine:

Center for Veterinary Medicine

Office of Compliance and Surveillance

Division of Compliance 

Metro Park North 2, Building #4

7519 Standish Place

Rockville, MD 20855-7707

6. Center for Tobacco Products:

Center for Tobacco Products

Office of Compliance and Enforcement

Division of Enforcement and Manufacturing

10903 New Hampshire Avenue

Building 75, Room 7464

Silver Spring, MD 20993

7. Emergency Operations Center:

FDA Emergency Operations Center, OC/OCM

10903 New Hampshire Avenue

Building 32, Room 1359

Silver Spring, MD 20993

C. Final Reports

When the investigation of any emergency, (e.g., disaster, or civil 

disorder) has been terminated, the lead division will submit a final 

written summary to OC/OCM/EOC with a copy to the responsible 

center emergency coordination unit. This summary will be prepared 

using previous reports, records of meetings, chronologies, and reports 

from cooperating officials.

8-7 HEADQUARTERS OPERATING PROCEDURES

8-7-1 FDA Emergency Operations Center

The FDA EOC will monitor all emergency alerts/investigations and serve 

as the agency-wide and inter-agency focal point for 24-hour, 7-day 

communications concerning developing and active emergency situations.
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-12

A. Emergency Alerts

FDA headquarters units that receive initial emergency alerts from 

consumers and other sources outside FDA will report the information 

to the EOC. If potential danger to health is involved, the EOC will notify 

the affected program and district director(s) immediately at the 

telephone number listed in the “ORA Directory” in the IOM. If an 

investigation is requested by another headquarters unit, the 

procedures established in FMD 17, Field Assignment Issuances 

Guidelines for Headquarters Offices allow requests to be issued 

directly to the action division or office with copies to the appropriate 

Program Director, ORA unit, and other center or office indicated. See 

also 8-4, Notification of Emergencies – Terminology.

B. EOC 24-Hour Telephone Contacts

After hours, or when the command center is not in operation, calls can 

be made to the 24-hour emergency number handled by the answering 

service. In the event that calls are designated as an emergency by the 

caller, the answering service will contact the late duty officer (LDO) or 

alternate LDO (ALDO) by cell phone or pager or both.

FDA Emergency Operations 24-hour telephone number is 

866-300-4374.

C. Headquarters Coordination

The EOC will immediately advise the appropriate ORA offices, the 

center emergency coordination unit and ORA of significant emergency 

alerts or when any investigation reaches presumptive status. OMA will 

also be notified when public press coverage is ongoing or imminent. 

The Office of Legislation (OL) will be alerted when there is or may be 

congressional interest. The EOC will forward to OPOP copies of all 

reports from ORA offices pertaining to state and local activities, 

actions, and agreements; and any press releases issued, e.g.,

information required under 8-5, Termination of Emergency 

Investigation. 

The EOC will prepare updated, periodic status reports on such alerts 

and investigations. These reports will be expedited to the Office of the 

Commissioner, the ACRA, and the ORA Office of Operations. 

Electronic mail will be used to distribute additional copies to other

headquarters offices, responsible centers and to other appropriate 

units.

All reports required by the Department on disasters, civil disorders, or 

other emergencies will be prepared by the EOC for distribution within 

ORA Headquarters and the appropriate office within DHHS.

D. Interagency Liaison

The EOC will coordinate information concerning emergencies with 

headquarters offices of other Federal agencies in accordance with

RPM Section 8-7, Interagency Coordination. When commerce with 
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-13

Canada or Mexico is involved, coordination will be by the EOC in 

cooperation with the Office of International Programs (OIP). When 

other foreign governments are involved, the EOC will advise OIP so 

that office may establish and coordinate with the EOC the maintenance 

of communication channels.

8-7-2 Center Emergency Coordination Units

All centers will maintain an emergency coordination function that will serve 

as the focal point for intra-center communications with the EOC. Centers 

will be responsible for scientific evaluations and for policy decisions, in 

cooperation with ACRA, in their respective program areas. Centers will 

continue ongoing interagency liaison activities to the extent possible as 

emergency coordination with other agencies is managed pursuant to 8-7, 

Interagency Coordination.

Each center has identified the office listed in 8-6-5, Reporting, to serve as 

its coordination unit. These units facilitate any recall and case 

development activities that may be associated with an emergency.

A. Inter-Office Communications

Each center's emergency coordination unit will provide the EOC with a 

telephone number that will be the contact number for communications 

with the EOC during any stage of an emergency. The phone shall be 

suitable for conference calling.

B. After Hours Communication

Each center emergency coordination unit will provide the EOC with a 

call list that will provide 24-hour/7-days a week coverage. (A continuing 

effort will be made to evaluate various electronic communications 

systems to supplant the call lists.)

C. Reporting by Center and on-site emergency coordinators

Center emergency coordinators will maintain concise chronology of 

center activities similar to that which coordinators maintain (see 8-6-4, 

Emergency Management). When the copy of the final report (see 8-6-

5, Reporting) is received from the lead division, the center will use its 

chronology during its review of the division report. The Center will then 

send any comments to the EOC before the EOC prepares a final report 

on the emergency.

8-7-3 Office of Regulatory Affairs

The Office of Crisis Management/EOC will serve as the focal point for 

emergency operations and communications within the Office of the 

Commissioner. Any information received by ORA will be discussed as 

appropriate with the Office of Crisis Management, the Commissioner, the 

Deputy Commissioner for Operations, and with other Deputy 

Commissioners both during business and non-business hours. 

This does not preclude the immediate reporting of significant emergency 

information to the Commissioner/Deputy Commissioner for Operations by 
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-14

the Director of Office of Operations, the Center Directors, or the Director 

or Deputy Director, EOC.

D. Responsibility for Policy Statements

The Office of Crisis Management and the ACRA or the ACRA’s

designee, working with the responsible centers and ORA, will develop, 

issue, and approve any new or revised regulatory policy that is 

required by an emergency situation.

E. ORA Call List

The order in which EOC staff should call ORA personnel during nonbusiness hours is:

1. Associate Commissioner for Regulatory Affairs

2. Assistant Director for Management

3. Deputy Associate Commissioner for Regulatory Affairs

4. Director, Office of Enforcement and Import Operations

5. Director, Office of Partnerships and Operational Policy

8-7-4 Office of Partnerships (OP)

The Office of Partnerships (OP), in cooperation with the programs or 

divisions, will coordinate Agency interaction with state and local agencies 

in emergency situations.

OP will maintain FDA's rapid communication system to state governments, 

major municipalities and poison control centers. OP will also continue the 

ORA OPOP/state association efforts to develop uniform emergency 

operational guidelines.

A. In emergency situations, OP will:

1. Ensure that the governors' offices have been notified of 

significant confirmed emergencies in their states;

2. Notify all states of confirmed emergencies involving two or more 

states.

3. Indicate potential or problem products entering commerce; and,

4. Prepare (or distribute) information requested by states for their 

emergency roles, and assure that states are fully advised as to 

what action the Agency can recommend to them under the 

circumstances of the specific emergency.

B. As routine functions, OPOP will:

Maintain a directory showing 

1. the responsibilities of major state organizations;

2. names, telephone numbers, and addresses of key state 

personnel; and
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-15

3. other information needed to quickly enlist nation-wide state and 

local assistance to FDA's emergency operations.

8-8 INTERAGENCY COORDINATION

Liaison activities with responsible government agencies at the federal, 

state, and local levels must be effective during emergency situations to 

help ensure that resource allocations are efficient, that policy is 

understood, and that roles are well defined. Considering that federal 

agency responsibility varies from one emergency to another and that state 

and local government organizations differ from the federal model, the 

specific agencies that should cooperate in a given situation will depend on 

the problem and its location.

The EOC will coordinate all interagency liaison activities during 

emergencies and will establish communications with the headquarters 

office of the responsible federal agencies. The lead division will establish 

communications with offices of the responsible federal agencies. The EOC 

and the Division of Mammography Quality and Radiation Programs, 

CDRH, will share radiological emergency interagency liaison in 

accordance with attachment A.

Both the lead division and other investigating divisions will establish 

communications with responsible state agencies. State agencies often 

receive assistance from local agencies, universities, and other units in 

carrying out their responsibilities. Usually FDA will work through the state 

in coordinating efforts on the local level. Depending upon the state, it may 

be more appropriate for FDA division offices to work directly with such 

local units.

8-8-1 Agencies FDA Cooperates With In Emergency Situations

These agencies may be grouped under five broad areas of responsibility, 

as follows:

A. Overall emergency management;

B. Consumer products;

C. The environment;

D. Human health; and,

E. Animal health.

8-8-2 Federal Agency Checklist

The following agencies and position titles should be considered for the 

appropriately relevant emergency:

A. Overall Emergency Management

Federal Emergency Management Agency (FEMA)/Department of 

Homeland Security (DHS).
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-16

B. Consumer Products

1. Food Safety and Inspection Service (USDA/FSIS);

2. Consumer Product Safety Commission (CPSC);

3. National Oceanic and Atmosphere Administration (NOAA) 

National Marine Fisheries Service (NOTE: The NOAA Seafood 

Inspection Program is often referred to as the U.S. Department 

of Commerce (USDC) Seafood Inspection Program and uses 

marks and documents bearing the USDC moniker);

4. Defense Logistics Agency (DLA);

5. Department of Defense (DOD); 

6. Contract Compliance Service, Veterans Administration (VA);

7. Environmental Protection Agency (EPA), Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) Products; and,

8. Federal Bureau of Investigation (FBI).

9. The Environment

10.Environmental Protection Agency (EPA);

11.National Oceanic and Atmospheric Administration (NOAA);

12.U.S. Coast Guard (USCG) (Oil Spills);

13.Nuclear Regulatory Commission (NRC);

14.Department of Energy (DOE); and,

15.Department of Transportation (DOT).

C. Human Health

1. Department of Health and Human Services – Secretary’s 

Operations Center (SOC);

2. Centers for Disease Control and Prevention (CDC);

3. National Institutes of Health (NIH), National Institute of 

Environmental Health Sciences (NIEHS);

4. Occupational Safety & Health Administration (OSHA); and, 

5. U.S. Department of Defense (DOD).

D. Animal Health

1. US Department of Agriculture (USDA) Animal and Plant Health 

Inspection Service (APHIS);

2. USDA National Animal Disease Laboratory (NADL);

3. US Department of the Interior, U.S. Fish & Wildlife Service; and,

4. Centers for Disease Control and Prevention (CDC).
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-17

8-8-3 State and Local Agency Checklist

A. Overall Emergency Management

Governor's Office (or Governor's Designated Emergency Contact).

B. Consumer Products

Appropriate state consumer protection counterpart.

C. The Environment

Appropriate state environmental protection counterpart.

D. Human Health

Appropriate state health counterpart.

E. Animal Health

Appropriate state animal and agricultural counterpart.

F. Agriculture

Appropriate state agricultural counterpart.

8-9 PRESS RELATIONS

The Office of Media Affairs (OMA) is responsible for issuing publicity and 

preparing answers to press inquiries about emergencies. OMA, in 

cooperation with the appropriate center and other Agency components, 

will:

A. Prepare and approve all talk papers and press releases;

B. Provide guidance to the lead and investigating divisions concerning the 

handling of local press inquiries;

C. Notify the department of pending media coverage;

D. Coordinate with the press operations of other agencies involved in an 

emergency;

E. Counsel FDA management about necessary public statements; and

F. Provide all Associated Press and United Press International wire copy 

about emergencies to EOC.

8-9-1 Notification of the Office of Media Affairs (OMA)

The OMA should be notified by any FDA unit that publicity has occurred 

relating to the emergency condition, as well as receipt of pending requests 

for information from the media or the public. The Director or any Deputy 

Director of OMA may communicate directly with the officials closest to the 

scene to ascertain what information needs to be released.
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-18

8-10 REFERENCES

8-10-1 General references

A. FMD 17 – Field Assignments from Headquarter Offices.

B. FMD 141 – Infant and Toddler Products.

C. IOM CHAPTER 3 – Federal - State Cooperation Subchapter 3.2 -

Federal Agency Interaction

D. IOM CHAPTER 8 – Investigations

a. Subchapter 8.3 – Investigation of Foodborne Outbreaks

b. Subchapter 8.4 – Investigation - Injury and Adverse Reactions.

E. Bovine Spongiform Encephalopathy (BSE) Response Plan, version 

2.1, September 2002.

F. FDA’s Emergency Operations Plan (EOP) available on Emergency 

Preparedness > Emergency Response on FDA.gov. The current plan 

is FDA EOP, version 2.0, March 2014.

8-10-2 Specific references

A. FMD 64 -- Epidemiological Investigations Alert Reporting Procedures, 

June 1, 1995, revision.

B. FMD 119 -- Consumer Products Complaint System March 5, 20122012

January 12, 1994, revision.

C. FMD 141-- Infant and Toddler Products, May 16,1995, revision.

D. Memorandum of Understanding between the Centers for Disease 

Control and the Food and Drug Administration, April 1, 1982.

E. MOU between the Centers for Disease Control and the Food and Drug 

Administration, 225-14-0017, 2014.

F. Multistate Foodborne Outbreak Investigations: Guidelines for 

Improving Coordination and Communication, National Food Safety 

System Project, Outbreak Coordination and Investigation Workgroup, 

February 2001.

G. Guide to Traceback of Fresh Fruits and Vegetables Implicated In 

Epidemiological Investigations, June 2006.

H. FDA’s Coordinated Outbreak Response and Evaluation (CORE) 

Network.

I. FDA Emergency Operations Plan, version 2.0, March 2014, Office of 

Crisis Management.

J. Office of Emergency Operations, Office of Crisis Management, Office 

of the Commissioner.
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

7/20/2018 8-198-19

8-11 Attachment A - Guidelines for Follow-up of Tampering 

A. Introduction

The Federal Anti-Tampering Act (FATA) passed by Congress in 1983 

makes it a Federal crime to tamper with certain consumer products and to 

commit certain other related acts. The Act provides specific statutory 

authority to the FDA to investigate tampering and alleged tampering of 

products that the agency regulates. There are five violations of the FATA:

1. Tampering, or attempted tampering, with a consumer product 

with reckless disregard for the risk of death or bodily injury.

2. Tainting a consumer product with intent to cause serious injury 

to the business of any person.

3. Knowingly communicating false information that a consumer 

product has been tainted.

4. Knowingly threatening to tamper with a consumer product.

5. Conspiracy to tamper with a consumer product.

A more detailed discussion of these violations can be found in the FATA 

(Title 18, United States Code, Section 1365).

B. Guidelines

1. The FDA Emergency Operations Center (EOC), 866-300-4374 

(HFA-615), must be promptly alerted to all tampering/threat 

incidents. This is in addition to the prompt reporting of incidents 

outlined in the Emergency Procedures section of the RPM, 

Chapter 8.

2. Division and other ORA offices should immediately notify the 

appropriate Office of Criminal Investigations (OCI) office upon 

receiving information concerning a tampering/threat incident. 

This notification will enable the OCI office and the Division office 

to coordinate operations.

3. OCI offices have primary responsibility for liaison with lawenforcement agencies (i.e., FBI, state police, sheriff 

departments, and local police). In certain situations OCI may 

request ORA offices to maintain contact with and offer 

assistance to cooperating officials who investigate tampering 

incidents (i.e., FBI, USDA, state and local police, health 

department, coroner, and medical examiners).

4. The FBI expressed an interest in being notified in all tampering 

investigations involving extortion, serious injury or death, 

terrorism, and significant false reports. In all but critical 

circumstances such notifications will be done through the OCI 

office. In some situations the Division office may be asked by 

OCI to notify the FBI.
Regulatory Procedures Manual July 2018 Chapter 8 Emergency Procedures

8-20

5. All requests for assistance from other law-enforcement 

agencies, including status briefings and notifications, regarding 

criminal investigations must be coordinated through OCI office.

6. Complaints/reports concerning products subject to USDA 

regulations should be immediately referred to their local contact 

of USDA for their follow-up. The Division office should promptly 

notify the OCI office and EOC of all such referrals.

C. When an alleged or suspected tampering incident is reported to FDA, 

the Agency must attempt to determine whether tampering has actually 

occurred or whether some other problem such as a manufacturing or 

distribution defect is involved. EOC and the centers are available to 

offer expert advice on possible manufacturing defects. The 

manufacturer can also provide information on defects. In addition, we 

should seek to determine where the tampering occurred (e.g., in the 

retail store, at the manufacturing site, etc.)

D. The OCI office will have primary responsibility for all criminal 

investigations of tampering/threats incidents. In those incidents where 

OCI does not or cannot initiate a criminal investigation because of 

resource limitations, the Division offices must continue the 

investigation. Division offices must closely coordinate their efforts with 

OCI offices. In these special situations the Division office must keep 

the EOC and OCI office advised of their progress. Any referrals to lawenforcement agencies, other than OCI, may be made only after 

obtaining the concurrence of OCI office. The OCI Headquarters will 

provide details on tampering cases investigated by the OCI office to 

EOC for forwarding to the proper centers for their information and any 

action they may have to take.

E. The Office of Chief Counsel/FDA (OCC) should be notified as soon as 

an FDA component determines that a case will be referred to a United 

States attorney in the following circumstances:

F. Where there is a conspiracy.

G. When an FDA regulated entity is included as a defendant.

H. When Title 21 charges are contemplated.

In the absence of one of these three circumstances OCC need not be 

notified prior to referral to a United States attorney; however, OCC should 

be sent a copy of the charging document that is filed with the court.