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For Business and Industry:
Notice 57-05 - Revised Version of the FSIS Handout, "Notice To Give Establishment Management When Certain Regulatory Samples are Taken"
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Q. What is a threat agent?
A. "Threat agent" is a generic term used by FSIS for substances (e.g., chemicals, microbial agents) that an individual looking to do harm might intentionally add to the food supply. FSIS now conducts tests for some potential threat agents to increase the security of the food supply. Which agents are tested for is decided based on the likelihood of an agent being used in the food supply. For security reasons, FSIS does not make publicly available the list of threat agents of concern or the list of threat agents for which it tests.
Q. Will the plant be informed if a positive or negative result is found for a threat agent?
A. FSIS will not state at the time of sampling whether a particular sample will be tested for threat agents. If the threat agent testing is negative, FSIS does not notify the establishment or the FSIS inspector that the sample was tested for a threat agent. Any screening tests for threat agents are completed within the same timeframe as food safety tests. Therefore, if the results of food safety tests come back negative, and there is no information on threat agent tests, that indicates that any tests conducted for threat agents were negative.
Notice 57-05 does not detail the reporting of a positive result because such a result will be handled on a case-by-case basis with the establishment being notified immediately and participating in discussions as to actions.
Q. What are the exact criteria for random sampling of possible threat agents? Is it random based on risk of the product, risk associated with the nation's threat condition, or suspicious activities in certain parts of the country?
A. Although Notice 57-05 does not detail sampling parameters for threat agent tests, more details can be found in FSIS Directive 5420.2, Rev. 2, Homeland Security Threat Condition Response - Handling of FSIS Laboratory Samples Under Declared Heightened Threat Conditions. As outlined in that directive, depending on the threat condition level (yellow, orange, or red) declared by the Department of Homeland Security, and whether there is specific information regarding a threat to the food supply, different percentages of meat, poultry, or egg product food safety samples will be tested for potential threat agents. The sampling to be conducted will not necessarily be random but will be risk based, taking into account product types and any specific intelligence information.
Q. Numbers 3 and 4 on the notice seem contradictory since number 3 states that all analyses on the sample will be reported in one response, while number 4 indicates that FSIS will not respond to a threat agent; what is the difference?
A. Number 3 on Notice 57-05 is meant to indicate to the establishment that it will not receive a separate result for any analyses of potential threat agents that might have been conducted on a given sample.
Number 4 on Notice 57-05 further clarifies that FSIS does not plan on reporting to an establishment that a threat agent analysis was conducted. FSIS does not want to indicate when samples are/have been tested for threat agents because any such information could indicate to someone looking to do harm which batches of food to target to avoid the tests for threat agents. . Any screening tests for threat agents are completed within the same timeframe as food safety tests. Therefore, if the results of food safety tests come back negative, and there is no information on threat agent tests, any tests conducted for threat agents were negative.
Q. Are FSIS labs conducting the threat agent analysis?
A. FSIS laboratories are conducting the analyses of FSIS food safety samples for potential threat agents. FSIS laboratories have established protocols for conducting that testing. FSIS is also a member of the Food Emergency Response Network (FERN), which is a network of laboratories that use common, established protocols and have a secure electronic link (eLEXNET) in place to facilitate sharing of protocols and test results. If there is an emergency situation where the number of samples needed to be tested exceeds the capacity of FSIS laboratories, FSIS might call on its FERN partners to conduct some of the tests for threat agents.
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Last Modified: February 13, 2006 |
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