FSMA 101: What to know about Inspection and Compliance

For the first time, the FDA has a legislative mandate to require comprehensive, prevention based controls across the food supply. The legislation transforms FDA’s approach to food safety from a system that far too often responds to outbreaks rather than prevents them.

Here's a quick breakdown of a few things you need to know about the insepction and compliance elements of the new ruling. 

Mandatory Inspection Frequency

FSMA establishes a mandated inspection frequency, based on risk, for food facilities and requires the frequency of inspection to increase immediately. All high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter.

Within one year of enactment, the law directs FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years. To accomplish this projected goal, the FDA and other agencies in the United States will work in partnership or collaborate with foreign governing bodies for help, due to lack of resources to meet the demand.

Record Keeping

This rule requires that the FDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans. FDA’s access to records was expanded beyond records relating to the specific suspect article of food to records relating to any other article of food that the FDA reasonably believes is likely to be affected in a similar manner.

In addition, FDA can now access records if FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals.

Testing by Accredited Labs

While FSMA requires lab accreditation, the FDA has not yet released a proposed rule related to lab accreditation. FDA officials have indicated a draft regulation is now under development by the FSMA Laboratory Accreditation Work Group.

For more information: Record Availability Requirements: Establishment, Maintenance, and Availability of Records, FDA-2002-N-0153