Bioterrorism Act of 2002
Also known as Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
U.S. Federal law governing, among other things, the requirements of food manufacturers to provide recall information to regulators in the event of food contamination.
Without getting into details and procedures, the Bioterrorism Act intends to protect Americans against specific planned contamination of the food supply. Unlike other regulations which are to protect against accidental contamination, this Act anticipates an intentional sabotage. Also, unlike other regulations, if a companies systems fail when they are needed to perform, this is not a matter of a fine, it is a matter of people potentially dying.
Any company that distributes anything that is normally ingested and whose product is widely distributed may be a target. Again unlike safety regulations where some processes and products are more prone to problems than others, a terrorist will target the most successful of products for maximum effect.
On a very high level, the requirement is that one should be able to take any contaminated component, and move up or down the chain from it – in other words find out where it came from and who got it, whether in process or end product – in the quickest amount of time in order to quarantine, provide antidote, or whatever. This requirement cuts across the traditional business boundaries. The farmer has to be able to tell what trucks carried his product, and the manufacturer needs to account for it while in its possession through its processes, and then what retailer received it.
The basic unit that needs to be traced in this way is a lot/batch/serial number. Given the lot that appears on the consumer package, theoretically, one should be able to find out what field the flour that is a part of that product, was grown in, and what day it was picked. Conversely, given a shipment of wheat, the government should be able to determine exactly what lots of what products contain that wheat, or its by products, and where each package is.
Time and accuracy are of the essence when lives may be at risk. The FDA needs to be able to trace from "Farm to Fork".
On the face of it, this is a relatively simple exercise, both from a management perspective, and a technical perspective. It is no more or less than a genealogy program – who were the parents of this child, who were its children? But it is a much more complex problem than it appears.
Specifically, within 24 hours of a request from the FDA, the food processor needs to be able to provide the following information. Failure to comply may carry civil or criminal penalties:
Identify the immediate non-transporter sources, whether foreign or domestic, of all foods received including lot number, code date, or other batch identifiers (the farm or immediate supplier to your facility); Identify the immediate non-transporter receivers of all foods released including ;ot number, code date, or other batch identifiers; and Identify the specific source of every ingredient used to make every lot of finished product
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This page last updated: 08/30/2011