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Recordkeeping Key to the New Era of Prevention

A primary goal of the FSMA is greater prevention. While this has always been a general goal of food safety practices industry-wide, the new requirements are designed to mandate for all companies what many of the leading companies consider best practices today.

Implementing a food safety plan under FSMA requires continual documentation of ongoing activities, which enhances a company’s preparedness to minimize the impact of a food safety incident.
Implementing a food safety plan under FSMA requires continual documentation of ongoing activities, which enhances a company’s preparedness to minimize the impact of a food safety incident.
A primary goal of the Food Safety Modernization Act (FSMA) is greater prevention. While this has always been a general goal of food safety practices industry-wide, the new requirements are designed to mandate for all companies what many of the leading companies consider best practices today.
 
In doing so, the FSMA represents a major effort to establish a risk-based and global systems approach that takes prevention to the next level.
 
We now have seven proposed rules issued by the FDA, and one common theme among them all, aside from prevention, is the need to keep records. The FDA essentially has the approach that “if you didn’t document it, you didn’t do it.” Thus, many companies will have to significantly upgrade their ability to document production, from processing and packaging to their and their partners’ supply chain activities. Recordkeeping is central to food safety efforts and now the law. It leads the list of these aspects of the law implemented since its 2011 enactment:

• Inspection of records: These include manufacturing records; raw materials (ingredients and packaging) receipt records; product distribution records; product inventory records; test records; recall records; reportable food records; customer distribution lists; and records of complaints and adverse events. It is important to remember that the FDA has the authority today to look at records.

• Mandatory recall authority: The FDA gained authority to mandate a recall, something it could only do for infant formula until FSMA. This would be based on a reasonable probability of serious adverse health consequence or death.

• Authority to suspend the registration of food facilities: This applies when food manufactured, processed, packed, received, or held by a facility is found to have a reasonable probability of causing serious adverse health consequences or death to humans or animals. This can effectively shut down a facility by halting imports or exports into the U.S. as well as domestic interstate or intrastate commerce.

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