Table of Contents

I. SCOPE

II. PURPOSE

III. DEFINITIONS

IV. BACKGROUND AND HISTORY

V. BSE EMERGENCY ORGANIZATION AND OPERATING PROCEDURES

A. INITIAL NOTIFICATION OF A BSE ALERT AND BSE EMERGENCY

B. INITIATING RESPONSE AND DECLARING AN EMERGENCY

C. EMERGENCY OPERATIONS RESPONSIBILITIES

D. EOC OPERATING PROCEDURES

VI. HEADQUARTERS RESPONSIBILITIES DURING AN EMERGENCY

A. E.O. COORDINATOR RESPONSIBILITIES

B. CASE MANAGER RESPONSIBILITIES

C. PUBLIC AFFAIRS RESPONSIBILITIES

D. THE DIVISION OF FEDERAL-STATE RELATIONS (DFSR) RESPONSIBILITIES

E. THE OFFICE OF PUBLIC AFFAIRS (OPA) RESPONSIBILITIES

F. THE OFFICE OF INTERNATIONAL PROGRAMS (OIP) RESPONSIBILITIES

G. CENTER RESPONSIBILITIES

1. Center Emergency Coordinator

2. Center BSE Coordinator

VII. DISTRICT/REGIONAL RESPONSIBILITIES DURING AN EMERGENCY

A. 24-HOUR COMMUNICATIONS SYSTEM

B. EMERGENCY ALERTS

C. INVESTIGATIONAL INSTRUCTIONS

D. EMERGENCY MANAGEMENT

E. DOCUMENTATION

F. REPORTING

VIII. FDA AND USDA COORDINATION

IX. EMERGENCY CASE PROCEDURES

X. RECALLS

XI. FINAL ASSESSMENT

XII. IMPLEMENTATION

XIII. REFERENCES

ATTACHMENT A - BSE Emergency Phone Numbers

ATTACHMENT B - Center for Veterinary Medicine BSE Action Plan

ATTACHMENT C - Center for Food Safety and Applied Nutrition BSE Response Plan

I. SCOPE

The BSE Response Plan is designed to prepare and guide United States Food and Drug Administration (FDA) personnel, other Department of Health and Human Services (HHS) agencies and other federal agencies for emergencies involving Bovine Spongiform Encephalopathy (BSE). While the Plan does not cover every conceivable situation, it does supply the basic guidelines regarding most BSE emergencies that may be encountered by the FDA.

FDA headquarters and field operations should follow these BSE response procedures. Emergency operations will be conducted within the framework of the BSE Response Plan with coordination by FDA Emergency Operations (E.O.).

II. PURPOSE

This Response Plan provides guidance for the FDA, outlining responsibilities and establishing procedures to act immediately in cases involving a possible BSE incident. These procedures cover FDA regulated products or ingredients that may have been introduced into the U.S. market.

Prompt emergency actions are dependent upon the expeditious reporting and investigation of significant incidents and complaints relating to FDA-regulated products.

For the purpose of this procedure, the following definition of "emergency" shall apply:

"An unforeseen combination of circumstances or the resulting state that calls for immediate actions." (Chapter 7, Regulatory Procedures Manual (RPM))

III. DEFINITIONS

Various terms and definitions are used in describing the status of an emergency. Additionally, there are numerous BSE-related terms and abbreviations used within this plan; for simplicity most are defined or described relative to the usage within the plan:

Bovine. Cattle or relating to cattle.

Bovine Spongiform Encephalopathy (BSE). A disease (also known as mad-cow disease), which is a progressive, lethal central nervous system disease (CNS), strictly targeting cattle. BSE is characterized by the appearance of vacuoles, or clear holes in neurons in the brains of affected cattle that give the brain the appearance of a sponge or spongiform.

BSE Alert. A formal notification issued by a FDA or other organization to Emergency Operations when situations or incidents involve reports (confirmed or unconfirmed) regarding:

1. Any imported animal feed or animal feed ingredient from a BSE Restricted Country that may contain animal tissue, as addressed by Import Alert #99-25.
2. Any domestic animal feed or animal feed ingredient that contains prohibited materials obtained either from a BSE Restricted Country, or from an unknown source.
3. Any food, dietary supplement, cosmetic, drug, device or biologic that contains or may contain material contaminated with the BSE agent or that may have become contaminated with the BSE agent or that was imported in violation of a relevant import alert or regulation.
4. Any report of a suspected or confirmed case of variant Creutzfeldt-Jakob disease by the Centers for Disease Control and Prevention (CDC) to be vCJD in a person who has not been in a BSE restricted country.

BSE Emergency. (1) Situations involving a presumptive or confirmed diagnosis of infection by the alleged BSE agent in any bovine or product derived from a bovine (domestic or imported) in the U.S. (2) Any report of a confirmed case of disease caused by the BSE agent in other mammalian species in the U.S.

BSE Restricted Country. A country that is listed in Title 9, Part 94.18 of the Code of Federal Regulations (CFR). For a list of countries refer to the following website: http://www.aphis.usda.gov/vs/ncie/country.html

Central Nervous System (CNS). Suspect Bovine. A bovine showing signs of a CNS disease as designated by the United States Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS). The signs of suspected CNS disease in cattle may include the animal's lack of coordination, aggression, seizures, and fine head tremors.

Creutzfeldt-Jakob Disease (CJD). A rare neurological disease that usually afflicts persons over 55 years of age. CJD was first identified in the 1920s, and it occurs at a rate of about one person per million each year worldwide. It is important to note that this incidence rate represents an average over time. Because age is a key factor in evaluating CJD distribution, and because the disease tends to strike people over the age of 55, the actual rate is higher for people in this age range. ). CJD in its natural form was first defined in the 1920s by German physicians Hans Gerhard Creutzfeldt and Alfons Jakob.

Confirmed Positive BSE Case. A BSE presumptive positive case that has been confirmed by the United Kingdom's Central Veterinary Laboratory.

Presumptive Positive BSE. A bovine that APHIS has designated as a laboratory test positive for BSE, with signs of CNS disease and the observation of histopathological lesions of BSE in the brain and/ or a positive test for immunohistochemical staining for the BSE agent.

Prions. Infectious proteins that are the leading hypothetical causative agents of spongiform encephalopathy.Prions consist of a single molecule containing about 250 amino acids. There is a normal form PrP, which has mostly an alpha helix structure. There is also an abnormal form PrPSc, which has mostly a beta sheet structure and is believed to be the infectious agent in Transmissible Spongiform Encephalopathy.

Transmissible Spongiform Encephalopathy (TSE). Name for a group of brain diseases that causes sponge-like abnormalities in brain cells. TSE diseases are associated with accumulation of abnormal prion protein in the brain.

Variant CJD (vCJD) or new variant CJD (nvCJD). Name given to a newly identified human TSE which is significantly different from other forms of CJD in that it is seen in younger patients. vCJD is believed to be caused by the transmissible agent responsible for BSE. Signs and symptoms vary but may include loss of coordination, personality changes, mania and dementia. (Both vCJD and nvCJD refer to the same entity). vCJD is used throughout this information resource primarily.

IV. BACKGROUND AND HISTORY

Bovine Spongiform Encephalopathy (BSE), known as "mad cow disease," is a transmissible, slowly progressive, fatal, degenerative disease affecting the central nervous system (CNS) of adult cattle. Neurologic clinical signs and a long incubation period characterize BSE.

BSE belongs to a family of diseases known as TSEs. A transmissible agent, which is yet to be fully characterized, causes these diseases. Specific types of TSE's include scrapie, which affects sheep and goats; transmissible mink encephalopathy; feline spongiform encephalopathy; chronic wasting disease of deer and elk; and five rare diseases in humans-- kuru, CJD, Gerstmann-Straussler-Scheinker syndrome, fatal familial insomnia (FFI), and new-variant Creutzfeldt-Jacob disease (vCJD) (Will et al. 1996.).

BSE was first recognized as a new distinct disease of cattle by researchers at the Central Veterinary Laboratory of the British Ministry of Agriculture, Fisheries and Foods (MAFF) at Weybridge, England, in November 1986 (Wells et al, 1987). However, there are indications that the first clinical case of the disease was observed as early as April 1985 (Wilesmith et al. 1988).

A surveillance program begun in 1990 by the USDA has found no evidence of BSE in U.S. cattle. In addition, the USDA, FDA and the U.S. livestock industry have taken a number of measures for nearly a decade to prevent BSE from occurring in the U.S. These actions include banning importation of cattle and cattle products from countries where BSE has been reported or where adequate surveillance programs are not in place; monitoring and testing for BSE in U.S. cattle; and, educating producers and the public about the disease.

To prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the feeding of mammalian protein to ruminant animals in most cases. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997.

V. BSE EMERGENCY ORGANIZATION AND OPERATING PROCEDURES

Successful response to a BSE emergency will require the coordinated efforts of FDA, USDA, states, and other organizations. FDA districts, in cooperation with states and other federal counterparts, will conduct investigations and inspections to identify the scope of the emergency and take action to control the emergency at the local level. FDA Emergency Operations will serve as the focal point for coordination of multiple district responses, public and media inquiries, and the headquarters level response efforts of FDA Centers, Offices, and management.

FDA's response to BSE will involve notifying appropriate organizations, activating the EOC, performing functions described in this response plan and other FDA procedures, and coordinating the response with outside organizations.

A. INITIAL NOTIFICATION OF A BSE ALERT AND BSE EMERGENCY

All incidents involving BSE should be reported to FDA's Emergency Operations (E.O.), Office of Regional Operations, Office of Regulatory Affairs (ORA), which serves as the agency's focal point for all emergency response activities on a seven-days-a-week, 24 hour- a-day-basis. The 24-hour FDA emergency contact number is (301) 443-1240, Fax (301) 827-3333, or e-mail to emops@ora.fda.gov.

After hours, or when the FDA's Emergency Operations is not in operation, the answering service will refer all BSE calls via pager to the Emergency Operations Late Duty Officer.

FDA headquarters, units from USDA/APHIS, units from USDA/ Food Safety Inspection Service (FSIS), FDA district offices, FDA Centers, other federal and state agencies, consumers, and other sources outside the FDA, may receive initial notification of a case involving BSE. This notification will be reported promptly by phone to E.O. A fax or email message should be sent to E.O. to confirm the initial phone notification to E.O. All information about the initial call and subsequent follow-up information are recorded by the E.O. duty officer. Additionally, any situation covered under the definition of a BSE Alert on page 3 shall also be reported.

An initial notification may include reports of contamination relating to animal-derived or animal-containing product from a BSE Restricted Country in any FDA regulated product, including foods with less than three percent meat content, dietary supplements, cosmetics, biologics, drugs, devices, or veterinary products. Alerts may be reports of suspect CJD cases or cases of vCJD. [Report should include information related to the history of the individual relating to blood or tissue donation (or receipt) in the case of CJD cases, which will occur in the population. Any history related to foreign exposure for these cases would also be useful.]

Reports should include the nature and effect of the notification including as much of the following information as available:

• Description of the emergency situation and status (presumptive or confirmed).
• Description and number of animal affected/dead, location, number in herd, and number of herd mates slaughtered and their date and location.
• Description of product utilizing the affected bovine derived material (brand name, size, lot number, etc.)
• Responsible firm (manufacturer, supplier, distributor) and contact person at the firm (phone number)
• Press coverage if any or anticipated, or any other pertinent information.
• Description of imported products in domestic commerce subject to BSE prohibitions.

If available, traceback information on products to source to include domestic distribution chain, and where relevant, customs entry data, responsible importer of record, and foreign shipper/manufacturer data.

See Figure 1 for a summary of the FDA Emergency Alert System.

B. INITIATING RESPONSE AND DECLARING AN EMERGENCY

FDA Emergency Operations will initiate response actions upon notification of a BSE incident. The E.O. Coordinator will activate the EOC and notify FDA Headquarters, affected District Offices, and the headquarters offices of other Federal agencies (USDA/APHIS and USDA/FSIS). Appropriate personnel will be asked to report to the FDA EOC. A formal declaration of an emergency by the Director of E.O. may be required to activate the appropriate emergency coordinating units within the agency.

C. EMERGENCY OPERATIONS RESPONSIBILITIES

A FDA BSE alert or BSE emergency will be coordinated by Emergency Operations, working with the appropriate Center Emergency Coordinator. Emergency Operations will have primary responsibility for ensuring that necessary investigations and actions are taken in response to BSE alerts and emergency situations.

Emergency Operations will coordinate information concerning emergencies with headquarters offices of other Federal agencies consistent with guidance in the Regulatory Procedures Manual (RPM).

Emergency Operations will notify the Office of International Programs (OIP) of (1) any real or potential imported products identified with mammalian protein, (2) BSE alerts or emergencies originating from foreign sources, and (3) products identified with mammalian protein or BSE exported from the U.S. to foreign sources.

Emergency Operations will prepare periodic updates or status reports on such alerts and investigations for the participating districts, FDA Headquarter units, and other agencies as appropriate.

Emergency Operations will routinely advise and/or notify FDA and other agency partners by telephone and e-mail regarding any BSE Alert or BSE Emergency, as these terms are defined in Section III, Definitions. Table 1 lists the initial notifications that Emergency Operations will make for a BSE Alert. Table 2 lists the notifications that Emergency Operations will make for a BSE Emergency. Emergency Operations will also notify other offices at FDA headquarters as appropriate for the situation. Figure 2 (see page 21) presents a flow chart of FDA's BSE emergency communications.

Emergency Operations will notify the Division of Import Operations and Policy (DIOP) of BSE emergencies originating from foreign sources and provide DIOP with any traceback information derived from the initial report. [DIOP is part of a multi-agency work group with the U.S. Customs Service (USCS) and USDA for joint operations related to BSE preventative measures and emergencies originating from foreign sources.]

D. EOC OPERATING PROCEDURES

Information on incidents/emergencies will come into the EOC by phone, fax, e-mail, letter, etc. This information will be recorded and followed-up by the on-call E.O. Duty Officer (case manager). The case manager is usually the person receiving the initial report or information. If the case manager determines that the preliminary information warrants further investigation the E.O. Coordinator is notified and briefed on the event status. The coordinator will confer with BSE Team members to coordinate investigations and scientific evaluations of the event.

During a BSE Response, the EOC follows the command system detailed in the BSE Response Plan to assign and designate staff. Positions include:

• E.O. Coordinator serves as the lead for FDA emergency operations.
• Case Manager ensures that response actions are properly directed to ensure successful resolution of the incident, and reports to the E.O. Coordinator.
• Public Affairs serve as the official source of incident information to be released to the public and the media.

These positions are pre-assigned to Emergency Operations Staff. Specific responsibilities are described in section VI. The EOC Staff may be needed to address administration issues, planning, liaison, logistics and finances issues related to the emergency situation and follow-up activities for FDA.

The E.O. Coordinator will mobilize personnel to the EOC.

Personnel that will report to the EOC for any emergency include:

a. BSE Emergency Coordinator from CVM

b. BSE Emergency Coordinator from CFSAN

c. Representative from the Office of Public Affairs (OPA)

d. Representative from the Division of Federal-State Relations (DFSR)

Other Offices may be asked to send representatives to the EOC if events or conditions affect areas under their purview. These include:

a. BSE Emergency Coordinator from CBER

b. BSE Emergency Coordinator from CDER

c. BSE Emergency Coordinator from CDRH

d. Representative from the Division of Import Operations and Policy (DIOP)

e. Representative from the Division of Field Investigations (DFI)

f. Representative from the Division of Field Science (DFS)

g. Representative from the FDA Office of the Commissioner (OC)

h. Representative from the Office of Regulatory Affairs (ORA)

i. Representative from the Office of Legislative Affairs (OLA)

j. Representative from the Office of International Programs (OIP)

The E.O. Coordinator will serve as the coordination point for consultation regarding command and operational decisions involving appropriate agency/departmental and inter-agency issues.

VI. HEADQUARTERS RESPONSIBILITIES DURING AN EMERGENCY

A. E.O. COORDINATOR RESPONSIBILITIES

The E.O. Coordinator mission is to serve as the lead for FDA Emergency Operations. The E.O. Coordinator serves as the facilitator coordinating activities of FDA Headquarters, the Centers, affected District Offices, and the headquarters offices of other Federal agencies in support of any possible needs relative to FDA in an emergency.

The E.O. Coordinator will coordinate dissemination of information to EOC staff responding to a BSE emergency. The E.O. Coordinator ensures that the information will be reviewed for appropriate action including referral to the field for follow-up as necessary.

E.O. Coordinator responsibilities include:

• Tasking coordinators in the centers
• Inter-agency communication
• Issuing instructions to staff
• Providing instructions to implement the plan
• Conducting staff meetings and briefings
• Providing input into decision-making
• Involving staff in decision-making
• Providing/clarifying legal authorities where inter-agency coordination is needed
• Directing/coordinating with other jurisdictions
• Recommending implementation of protective action measures
• Providing copies of the current plan or procedures for reference and use
• Retaining message logs for incoming and outgoing messages and transmissions

B. CASE MANAGER RESPONSIBILITIES

The Case Manager ensures that response actions are properly directed to ensure successful resolution of the incident, and reports to the E.O. Coordinator. The Case Manager directs the activities of the response personnel and ensures that they have adequate resources to perform their functions. The Case Manager is responsible for day-to-day operations of the EOC during an emergency or incident response and responsibilities include:

• Activating FDA BSE Response Plan
• Activating FDA EOC operations
• Establishing Command Center
• Managing overall response
• Reporting to E.O. Coordinator
• Coordinating all staff functions including issues with operations, planning, logistics, finance and public affairs
• Approving requests for procurement and release of resources
• Reviewing and commenting on proposed release of information by Public Affairs (PA)
• Approving plan for shift change and staffing issues
• Managing operations directly applicable to the primary mission
• Briefing and assigning operations personnel in accordance with the BSE Response Plan
• Implementing operations section of plan
• Assigning specific tasks to staff and volunteers

C. PUBLIC AFFAIRS RESPONSIBILITES

Public Affairs serve as the official source of incident information to be released to the public and the media. Public Affairs provide the mechanism for the public to receive vital information without interfering with response actions. Public Affairs responsibilities are:

• Establishing and maintaining single contact point for media
• Supplying the EOC with personnel to address public inquires.
• Maintaining ongoing briefings from E.O. Coordinator/Incident Manager
• Preparing initial information summary
• Arranging appropriate contacts between media and FDA Personnel

D. THE DIVISION OF FEDERAL-STATE RELATIONS(DFSR) RESPONSIBILITIES

The DFSR, in cooperation with the regions or districts, will coordinate Agency interaction with state and local agencies in identified BSE emergency situations.

DFSR will maintain FDA's rapid communication system to state governments, major municipalities and poison control centers. DFSR will also continue the ORO/State Association efforts to develop uniform emergency operational guidelines.

DFSR will maintain a directory showing the responsibilities of major state organizations, names, telephone numbers, and addresses of key state personnel, and other information needed to quickly enlist nation-wide state and local assistance to FDA's emergency operations.

In emergency situations, DFSR will:

• Assure that the governors' offices have been notified of significant confirmed emergencies in their states.
• Notify all affected states of confirmed emergencies involving more than one state.
• Indicate potential or problem products entering commerce.
• 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 concerning the specific emergency.

E. THE OFFICE OF PUBLIC AFFAIRS (OPA) RESPONSIBILITIES

OPA is the FDA lead office for releasing, developing and coordinating press releases to media outlets and concerned public groups. The Media Relations Staff is responsible for issuing publicity and preparing answers to press inquiries about emergencies.

Emergency Operations or the appropriate FDA unit should notify the Media Relations Staff when publicity occurs relating to the emergency conditions, or when requests for information are received from the media and/or public. The Director or designate of the Media Relations Staff may communicate directly with the officials closest to the scene to ascertain what information needs to be compiled and released.

OPA will:

• Prepare, approve and disseminate all talk papers and press releases coordinating with ORA and Centers.
• Provide guidance to the lead and investigating districts concerning the handling of local press inquiries;
• Notify the Department of Health and Human Services of pending media coverage;
• Coordinate with the press operations of USDA/APHIS-FSIS and other agencies as appropriate;
• Counsel FDA management about necessary public statements.

F. THE OFFICE OF INTERNATIONAL PROGRAMS (OIP) RESPONSIBILITIES

OIP is the agency lead office for communicating with the State Department, foreign and U.S. embassies, the U.S. Trade Representative (USTR), foreign governments, and international organizations.

When FDA learns of real or potential emergency situations concerning the importation or exportation of mammalian protein or other BSE emergencies involving foreign countries, Emergency Operations will promptly notify the Associate Director for Communications who will coordinate with the appropriate country desk officer(s) for the notification and exchange of information with the affected country (ies).

Information provided to and received from foreign governments will be handled as provided for under Title 21, Code of Federal Regulations Section 20.89. This regulation governs FDA’s communications with foreign governments under the Freedom of Information Act.

In addition, the OIP will also coordinate with FDA’s Emergency Operations Coordinator to provide timely notification with the appropriate degree of urgency to the following offices as necessary:

• The Embassy (ies) of the country or countries involved.
• The Office of Global Health Affairs/DHHS
• Desk Officers at the Department of State
• The office of the U.S. Trade Representative (USTR)
• Appropriate international organizations

Communication with the competent authorities and other parties sited in this section will be maintained as necessary and coordinated between OIP and FDA’s Emergency Operations Coordinator.

G. CENTER RESPONSIBILITIES

FDA Centers will participate in BSE response efforts when the event involves, or may involve, activities or products under their jurisdiction. FDA Emergency Operations will maintain contact with the Centers to ensure that they are aware of any changes in the situation that would necessitate their action.

1. Center Emergency Coordinator

Centers are responsible for scientific evaluations and for policy decisions, in cooperation with Emergency Operations and the Associate Commissioner for Regulatory Affairs (ACRA), in their respective program areas. All Centers currently maintain an "Emergency Coordinator", who serves as the focal point for emergency response with Emergency Operations. Each Center has a BSE committee that provides scientific, compliance and policy decision function. The Center Emergency Coordinators are consistent with Chapter 7-10, RPM.

2. Center BSE Coordinator

Each Center has a designated BSE coordinator that serves as initial contact point between Emergency Operations and the Center.

If notification of an incident involving BSE comes from ORA Emergency Operations, the Center BSE emergency coordinator will contact all appropriate Center staff. If notified by any other source, the Center BSE coordinators will notify Emergency Operations. The Center BSE Committee and all other appropriate FDA staff are listed on the Center BSE emergency coordinators’ Contact List.

The Center BSE Coordinators are responsible for:

• Maintaining daily contact with Emergency Operations staff on the status of the situation
• Providing daily updates to BSE Committee chair and other members as necessary until status is confirmed.
• Updating the BSE contact lists on a quarterly basis and sending the updates to Emergency Operations.
• Keeping a current BSE file that will include:

Center BSE Coordinators Contact List (Attachment A).

• Lists of all products known to contain bovine derived active ingredients and associated FDA product codes.
• Health hazard evaluations.
• Other literature related to human risk associated with BSE.
• Current scientific research concerning transmissibility and effective inactivation processes.
• Names of Committee members updated and provided to Emergency Operations as needed.

The Center BSE Coordinators are identified below:

VII. DISTRICT/REGIONAL RESPONSIBILITIES dURING AN EMERGENCY

FDA Districts will be the lead response organization when a BSE event occurs within the district boundaries. FDA Emergency Operations will maintain contact with the Districts and Regions to ensure that they are aware of any events that would necessitate their involvement in the response.

A. 24-HOUR COMMUNICATIONS SYSTEM

Each Regional/District office will maintain a means by which headquarters can communicate emergency situations on a 24-hour, 7-days-a-week basis. Each region/district will establish and maintain procedures for internal communications and provide for appropriate liaison and notification systems to city, county, and state governments, and local offices of Federal agencies.

B. EMERGENCY ALERTS

All reports of a BSE Emergency, a BSE Alert, or actual adverse effects associated with FDA-regulated products require immediate investigation and immediate reporting to E.O. by phone. E-mail or FAX (301-827-3333) status reports to E.O. Report the nature and effect of the emergency including the information outlined under Section III BSE Emergency Organization and Operating Procedures – Initial Notification

• Probable or actual distribution pattern, if known, for suspect product(s).
• Steps taken to coordinate FDA actions with state, local and other Federal officials. Also, any independent actions taken by state and/or local officials.
• Actions taken by firms, corrective actions, recalls, etc.

  C. INVESTIGATIONAL INSTRUCTIONS

Refer to IOM, Chapter 9, Investigations, for detailed investigative procedures.

D. EMERGENCY MANAGEMENT

a. Lead District

The district in which the emergency is occurring, will assume the lead investigative role in determining the cause of the emergency and obtaining necessary information for the Agency to confirm the health hazard.

If it becomes apparent during the course of the investigation that a firm in another district is responsible for the product involved in the emergency, the "lead district" designation will be transferred to the home district of the responsible firm.

Any change in the designation of "lead district" should be done in concurrence with E.O.

In certain widespread emergencies involving more than one responsible firm, E.O. may assume the lead role without designation of a "lead district."

The "lead district" will identify an ad hoc emergency management team to be headed by the District Director or a designated district person and a coordinator. The district will determine the exact number and mix of persons on the team. Any recommendations for reallocation of field staff between or among districts during emergencies should be directed to the Office of Regional Operations (ORO).

b. BSE 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 district office to facilitate communication and record review. In a widespread emergency, the involved districts may name additional coordinators as necessary. The coordinator will be responsible for advising management of actions needed to follow-up on the emergency and channeling all necessary communications. Any or all of the following steps should be included:

• Issuing assignments to district personnel to obtain the information necessary for Agency personnel to evaluate the health hazard of the situation;
• Monitoring assignments to assure timely completion;
• Arranging for continuing contact with investigators for flow of information;
• Seeking technical guidance through E.O. relating to the investigation, samples needed, etc.;
• Determining, in consultation with DFS and E.O., the appropriate laboratory to submit samples to and alerting that laboratory as soon as possible so that necessary preparations may be made.

• Keeping appropriate center, district, and regional officials informed of investigational and analytical progress;
• Preparing daily status reports;
• Contacting appropriate state and local authorities who are involved with the investigation;
• Serving as local FDA press contact concerning the emergency. The coordinator or other designated official will work with headquarters in preparing statements to the press.

NOTE: FDA field and headquarters employees may be asked to respond to media inquiries about ongoing investigations when not in a position to first seek guidance from the Media Relations Staff. All media inquiries on BSE related subject matter should be referred to the Office of Public Affairs. Care must be taken to ensure that only accurate, complete, timely, authorized and coordinated information is issued, and that the situation is put into full perspective.

The Media Relations Staff, directly or through E.O., should be notified as soon as possible after such media contacts.

Significant press coverage of the emergency should be reported as soon as possible to E.O. so that the Media Relations Staff, Division of Federal-State Relations, and other offices may be kept informed. Copies of state, company or other press releases should be obtained and FAXed to E.O. in a timely manner.

The FDA lead district office (or a large resident post) facility should generally serve as FDA's field 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 field command post at the cooperating lead state agency.

E. DOCUMENTATION

A chronology of the emergency situation must be kept, starting with the original alert to the emergency. It should be updated frequently since Agency or Department personnel often need this information on short notice.

Significant telephone conversations involving the emergency should be documented (by the participants) and forwarded to the coordinator daily.

Statistical data such as numbers of samples analyzed, inspections made, injuries reported, farms quarantined, etc., should begin early in the process and be maintained.

F. REPORTING

During the height of an emergency, the district's emergency coordinator should forward daily status reports by email or FAX to the E.O. command center with a copy to the responsible emergency coordinator for the center(s). Copies of such reports should also be forwarded to the "lead districts" by all investigating districts. E.O. 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).

VIII. FDA AND USDA COORDINATION

To effectively protect the public FDA and USDA are continuously working to strengthen communication and the working relationship between the agencies. Increasing diligence in sharing information and the exchange of contact liaisons should result in reducing the duplicative efforts in inspection and investigation of cases that may have cross-jurisdictional implications. It is anticipated that the BSE Response Plans for both organizations will increasingly incorporate and reflect appropriate inter-agency protocols and procedures.

IX. EMERGENCY CASE PROCEDURES

The following cases represent anticipated potential BSE emergencies. In most cases, the BSE causative agent is likely to be of foreign origin. Consequently, all emergency procedures must incorporate both domestic and import/international operations. Emergency Operations will be notified of all cases except Case A, Central Nervous System (CNS) Suspect Bovine.

X. RECALLS

If management of the BSE event includes product recalls, the recall procedures in Chapter 7 of the Regulatory Procedures Manual will be followed.

XI. FINAL ASSESSMENT

Emergency Operations and the participating Centers will carry out a final assessment of the emergency event to evaluate the FDA emergency response, identify any deficiencies, and make improvements to emergency procedures.

XII. IMPLEMENTATION

The agency policy is effective immediately.

XIII. REFERENCES

Wilesmith, J.W.; Ryan, J.B.M.; Hasten, W.D., et al. 1992. Bovine spongiform encephalopathy: epidemiologic features 1985 to 1990. Veterinary Record 130:90-94.

Will, R.G.; Ironside, J.W.; Zeidler, M.; Cousens, S.N.; Estibeiro, K.; Alperovitch, A.; Poser, S.; Pocchiari, M.; Hoffman, A.; Smith, P.G. 1996. A new variant of Creutzfeldt-Jacob disease in the UK. Lancet 347:921-925.

USDA Bovine Spongiform Encephalopathy (BSE) Response Plan, October 1998.

Information provided from FDA internal sources		Information provided from outside       sources (other Federal/state agencies,       foreign health officials, industry, press
EOC (Command Center-agency wide and interagency focal point for 24 hour, 7 day communications) Primary responsibility for monitoring emergency alert information and coordinating investigations and scientific evaluations Serves as focal point for communications and as catalyst to prompt action Advises appropriate field office, Center emergency coordination unit and ORA of significant emergency alerts or when investigation reaches stage II, presumptive status Coordinates information concerning emergencies with headquarters offices of other Federal agencies; and in cooperation with the Office of International Programs when other foreign governments involved

Attachment A

BSE EMERGENCY PHONE NUMBERS

U. S. DEPARTMENT OF AGRICULTURE
APHIS BSE RESPONSE TEAM	301-734-8073
Dr. Lisa Ferguson	301-734-8061
Dr. Linda Detwiler	609-259-5825
Allen Jenny	515-663-7929
FSIS
Loren Lang	202-690-6356
Robert Brewer	202-690-6567
FOOD AND DRUG ADMINISTRATION
Emergency Operations
ORA 24-hour Emergency Number	301-443-1240
Ellen Morrison, Director	301-827-5660
OCC
Joy Dawson	301-827-1144
Office of Public Affairs
Brad Stone, Senior Director for Media Affairs	301-827-6250
Larry Bachorik, Associate Commissioner for Public Affairs	301-827-6250
Kim Kunzig, Special Assistant	301-827-0857
CENTER BSE COORDINATORS AND CONTACTS LIST
OFFICE
CVM BSE Contacts
Gloria Dunnavan	301-827-1168
Dr. Burt Pritchett	301-827-0177
Kim Young	301-827-3353
Neal Bataller	301-827-0163
CFSAN BSE Contacts
John J. Guzewich, Office of Field Programs, Emergency Coordination and Response Staff	301-436-1608
Joe Baca, Director, Office of Field Programs	301-436-2359
Dr. John Kvenberg, Deputy Director, Office of Field Programs	301-436-2056
Joe Levitt, Center Director	301-436-1600
Janice Oliver, Deputy Center Director	301-436-2429
CDER BSE Committee Members
BSE Coordinator, Recall Coordinator/Drug Shortage
Michael Verdi	301-594-2456
BSE Working Group
Dr. Yuan-Yuan Chiu	301-827-5918
Neal Sweeney (alternate)	301-827-7340
Medical Officer
Dr. Russell G. Katz	301-594-2850
Chemistry, Manufacturing, and Controls Expert
Dr. Yuan-Yuan Chiu	301-827-5918
Frank Holcombe, Jr. (alt)	301-827-5845
Executive Secretary
June Cory	301-594-5608
CBER Committee Members
BSE Coordinator, Recall Coordinator/Drug Shortage
Jerome Davis	301-827-6220
Kathleen (Kay) Lewis	301-827-6206
BSE Working Group
Dr. David Asher	301-594-6432
Dr. Andrew Lewis	301-827-0650
Medical Officer
Dr. Andrew Lewis	301-827-0650
Dr. David Asher (alternate)	301-594-6432
Product Quality Expert
Rolf E. Taffs	301-827-4554
Gerald Feldman (alternate)	301-827-1720
Executive Secretary
Karen Orchard	301-827-0637
CDRH BSE Committee Members
CDRH Duty Pager 800-946-4646 Pin # 1713254
BSE Coordinator, Issue Manager
Nancy Pressley	301-594-3060
BSE Working Group
Dr. Kiki Hellman	301-443-7158
Epidemiologist
Dr. Lori Brown	301-594-0610
Product Expert
Karen Warburton	301-594-1744x122
Compliance Liaison
Adrianne Galdi	301-594-4586x141
Executive Secretary
Harry Sauberman	301-443-8879
Lisa Kennell (alternate)	301-443-8262 x166
OFFICE OF REGULATORY AFFAIRS (ORA)
Associate Commissioner for Regulatory Affairs
Dennis Baker	301-827-3101
Deputy Associate Commissioner for Regulatory Affairs
John Marzilli	301-827-3101
OFFICE OF REGIONAL OPERATIONS (ORO)
IMMEDIATE OFFICE
Deborah Ralston, Director	301-443-6230
Steve Solomon, Deputy Director	301-443-6230
DIVISION OF FEDERAL-STATE RELATIONS (DFSR)- 301-443-3360
Richard Barnes, Director	301-827-2905
Paul Raynes, Deputy Director	301-827-2910
DIVISION OF IMPORT OPERATIONS AND POLICY (DIOP) 301-443-6553
After Hours Number for Rotating Systems Branch Duty Officer –	301-594-2389
Carl Nielsen, Director	301-594-3852
Joseph McCallion, Assistant. to Dir. for Customs/Trade Liaison	301-443-6553 301-827-5663
DIVISION OF FIELD SCIENCE (DFS)
301-827-7605/7606
Before going down the list, first call:
Mike Olson, Director	301-827-1232
Tom Savage, Deputy Director	301-827-1026
OFFICE OF CRIMINAL INVESTIGATIONS (OCI)
Terry Vermillion, Director	301-294-4036
Horace Coleman, Deputy Director	301-294-4040
Rodney Turner, SAIC	301-294-4039
OFFICE OF INTERNATIONAL PROGRAMS
International Relations Staff
Walter Batts, Director	301-827-4480
Marilyn Veek, Associate Director	301-827-4480
ASSOCIATE COMMISSIONER FOR LEGISLATION
Office	301-827-3793
Mike Eck	301-827-3793
Jarilyn Dupont	301-827-3793
OFFICE OF THE COMMISSIONER
IMMEDIATE OFFICE
Deputy Commissioner
Lester Crawford, D.V.M., Ph.D.	301-827-2410/1622
Senior Associate Commissioner for International Activities and Strategic Initiatives - (Contact for TSE/BSE issues)
Dr. Murray Lumpkin	301-827-3310/2856
Department of Health and Human Services
Centers for Disease Control and Prevention
Dr. Lawrence Schonberger	404-639-3091
Dr. Ermias Belay	404-639-3091