I. PURPOSE

A. This directive outlines the steps that FSIS laboratories will initiate in the event that FSIS laboratory samples must be handled under heightened threat conditions.

B. This directive also :

- defines how threat condition declarations will be communicated to laboratory personnel,

- provides instructions to laboratory personnel on how to respond to the threat condition declarations,

- outlines the actions laboratory management will take in response to the threat condition declarations, and

- establishes how and to whom the results of samples generated under heightened threat conditions will be reported.

II. CANCELLATION

This directive cancels, FSIS Directive 5420.2, Homeland Security Handling of FSIS Laboratory Samples under Declared Heightened Threat Conditions, dated 6/18/2003.

III. REASON FOR REISSUANCE

This directive is being reissued in its entirety to reflect the current Agency organizational structure.

IV. REFERENCES

FSIS Directive 5420.1, Rev. 2 Homeland Security Threat Condition Response - Food Security Verification Procedures

FSIS Directive 7355.1 Use of Sample Seals for Laboratory Samples and Other Applications

V. BACKGROUND

In 2002, the White House Office of Homeland Security established a Homeland Security Advisory System based on color to provide a comprehensive and effective means to disseminate information regarding the risk of terrorist acts to Federal, State, and local authorities and to the American people. A declaration of a Threat Condition Elevated (Yellow) by the Department of Homeland Security indicates that there is an elevated risk of terrorist attacks. A declaration of a Threat Condition High (Orange) indicates that there is a high risk of terrorist attacks. A declaration of a Threat Condition Severe (Red) reflects a severe risk of terrorist attacks. While the threat may or may not involve the nation's food supply, it is imperative that certain actions be immediately undertaken by inspection program personnel during such threat conditions to ensure the safety of meat, poultry and egg products. Given what is required in responding to a credible threat of a terrorist attack, inspection progra m personnel must clearly understand their roles and what will be required of them in order to properly respond to that threat.

VI. NOTIFICATION

A. In the event of a declaration of any Threat Condition:

- Elevated (Yellow), when there is a significant risk of terrorist attacks

- High (Orange), when there is a high risk of terrorist attacks, or

- Severe (Red) which reflects a severe risk of terrorist attacks, by the Department of Homeland Security, the Office of Food Security and Emergency Preparedness (OFSEP) will inform the FSIS Administrator and senior executive leadership of all FSIS program areas.

B. The downgrading of threat condition declarations will be communicated by OFSEP to laboratory personnel through the senior executive leadership in OPHS.

VII. SPECIFIC THREAT CONDITION ACTIVITIES

The following are the actions to be taken in the event of a declaration of:

A. Threat Condition Elevated (Yellow), High (Orange) or Severe (Red) with no specific threat to the food and agriculture sector.

The laboratories will continue to monitor in-bound samples for evidence of tampering that may be related to food safety. The Laboratory Directors will notify laboratory employees of the heightened threat condition and will ensure that acceptable methods and adequate supplies are readily available to laboratory personnel to implement the Emergency Response Plan if needed. No further action will be taken unless directed by OPHS. However, laboratory personnel should report any unusual observations related to food security to the Laboratory Director/Director of the MOSPL, or designee.

B. Threat Condition High (Orange) with a specific threat to the food and agriculture sector.

The laboratories will activate the Emergency Response Plan and test up to 50% of all high risk food commodity samples for possible food security risks. Laboratories will receive specific instructions from the OPHS Executive Associate for Laboratory Operations on what measures should be taken in addition to those specified in the Emergency Response Plan.

C. Threat Condition Severe (Red) with a specific threat to the food and agriculture sector.

1. The laboratories will activate the Emergency Response Plan and test up to 100%of all high risk food commodity samples for possible food security risks. Laboratories will receive specific instructions from the OPHS Executive Associate for Laboratory Operations on what measures should be taken in addition to the Emergency Response Plan.

2. In the event that a food security threat is identified through routine testing of meat, poultry or egg products, the Assistant Administrator for OPHS may activate the laboratory Emergency Response Plan. The plan may be activated before a declaration of threat level has been issued by the Department of Homeland Security to ensure that adequate safety and security measures are in place to effectively respond to the threat identified.

3. OPHS may request that food security samples be taken from specific establishments. When food security samples are taken, the establishment is to be notified that its product has been sampled. FSIS strongly encourages establishments to hold the sampled lots pending notification of the results of the analysis.

VIII. LABORATORY SAMPLE SECURITY PROCEDURES

A. Safety Measures to Protect Laboratory Personnel

When a threat condition High (Orange) or Severe (Red) has been declared with a specific threat to the food and agriculture sector, all samples received by the FSIS laboratories will be subjected to intensified screening procedures upon delivery. All shipping containers will be opened within the confines of a fume hood or a laminar flow hood by appropriately trained laboratory personnel using personal protective clothing and devices (i.e., under BSL-2 conditions). In the event of an imminent threat to the safety of laboratory personnel, the Laboratory Director should immediately take safety measures to remove the affected laboratory staff from the threatening situation, and notify building security, appropriate local authorities, and the OPHS Executive Associate for Laboratory Operations.

B. Sample Security/Special Transport of Samples

1. All outbound and inbound sample boxes will be sealed for security and handled according to FSIS Directive 7355.1. The laboratories will continue to supply sample boxes, sampling material, and FSIS Form 7355-1 2A/2B for use during a declaration of threat condition High (Orange) or Severe (Red) with no specific threat to the food and agriculture sector. The laboratories will provide inspection program personnel with a supply of appropriate shipping containers, sampling supplies, and shipping instructions in the event of an High (Orange) or Severe (Red) declaration with a specific threat to the food and agriculture sector.

2. The FSIS laboratories ship overnight priority on a daily basis. In the event that air transportation is disrupted, the laboratories have the accounts and equipment to ship via ground transport. If normal land travel is disrupted, the laboratories have the accounts set up to ship by alternate methods.

3. If disruption of commercial carrier service occurs, the Office of Program Evaluation, Enforcement, and Review's Compliance and Investigation Division (OPEER CID), upon request by OPHS, will facilitate the delivery of food security samples to the appropriate laboratories to the maximum extent possible for analysis. OPEER CID will coordinate delivery by CID field personnel to the laboratories using assigned GSA cars or privately owned vehicles. If partial commercial carrier service exists, CID field personnel will be requested to deliver the samples to operating common carriers and to pick up samples at a destination for delivery to the laboratory. If no means of delivery is available, samples will be held securely under FSIS control in a frozen condition until delivery is possible. In all instances, food security samples will be handled in an expeditious manner while maintaining the integrity of the sample from collection to delivery.

C. Communication with Field Employees

Inspection program personnel requesting additional sample handling information, or sampling supplies should contact one of the three FSIS laboratories at one of the following Outlook addresses:
Sampling Supplies - Eastern Laboratory Sampling Supplies - Midwestern Laboratory Sampling Supplies - Western Laboratory
In the event that Outlook is not available, inspection program personnel should contact the appropriate laboratory through their District Office. Laboratory personnel will respond to the requests by the most expedient mode available.

D. Sample Overflow/Rerouting of Samples to Other Laboratories

1. If the sample capacity of any of the FSIS laboratories is exceeded, overflow samples will be routed to appropriate laboratories.

2. Food security samples received by a FSIS laboratory that does not have the capability or expertise to do the testing required, will be directed to an appropriate laboratory that does have the expertise, equipment and facilities to perform the necessary analyses.

3. The Director of the FSIS laboratory rerouting the overflow or special samples will communicate with the OPHS Executive Associate for Laboratory Operations to obtain specific repackaging and rerouting instructions.

E. Reporting of Results

Results of food security monitoring samples will be entered into, and maintained, in the Laboratory Information Management System. Any positive results will be reported to the OPHS Executive Associate for Laboratory Operations. In the absence of the Executive Associate for Laboratory Operations, positive results will be brought directly to the attention of the Assistant Administrator of OPHS to assist with proper and timely notification of law enforcement and public health authorities.

F. Sample Disposal

Samples that test negative are considered nonhazardous. Sample reserves and products resulting from analysis of negative samples are to be treated according to established laboratory protocol. Samples testing positive for a select agent may require shipping to a select agent registered laboratory. The FSIS laboratory will contact the MOSPL, the Environmental Health and Safety Division, and OPHS Executive Associate for Laboratory Operations for shipping/disposal instructions of such samples.

Direct all questions related to this directive through supervisory channels.

/s/ Philip S. Derfler
Assistant Administrator Office of Policy, Program, and Employee Development