RCI Safety Analysis: Food Safety Modernization Act Review, Part 4
Date Posted: January 17, 2013
This article is reprinted by permission from RCI Safety.
As stated in Article 1, the Food Safety Modernization Act (FSMA) presents the most sweeping reform of our food safety laws in more than 70 years.
The new law is ambitious as was the schedule to promulgate new regulations; however, to date only two proposed rules have been published in draft form.
Despite the delay in rule making, new enforcement tools are largely in place.
The FDA can now:
• Demand to inspect a broadened set of records related to food safety (Part 1),
• Suspend a facility’s registration (Part 1),
• Order the recall of an article of food (Part 2), and
• Order the administrative detention of adulterated foods (Part 2).
Inspections of Records (Section 101) effective January 4, 2011 Inspections of records differ from facility inspections.
FDA has been given a mandate to inspect food facilities on a routine basis.
Routine facility inspections will be addressed in subsequent articles.
QS 1: Under what circumstance would the FDA initiate an inspection of records?
If there is a reasonable probability that exposure to an article of food would cause serious adverse health consequences or death to humans or animals (farms and restaurants excluded).
QS 2: What type of records can the FDA request during an inspection?
Any records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article of food in any format (e.g. paper, electronic) at any location.
Suspension of Registration (Section 102(b)) effective July 3, 2011
QS 3: Under what circumstance would the FDA suspend the registration of a food facility?
Under the same circumstances that would initiate an inspection, if there is a reasonable probability that exposure to an article of food would cause serious adverse health consequences or death to humans or animals.
QS 4: What effect does a suspension have upon a facility?
If a facility’s registration is suspended, the facility cannot import or export food into the United States or introduce food into interstate or intrastate commerce in the United States effectively shutting down all food related operations of the facility.
QS 5: What happens following a suspension?
The facility has an opportunity to state their case at an informal hearing within two (2) business days of the suspension order. If the FDA determines, based on evidence presented, that grounds do not exist to continue the suspension it may be lifted.
If the FDA determines that suspension remains necessary, the facility will be required to submit a corrective action plan to demonstrate how the facility plans to correct the conditions leading to suspension.
QS 6: At what point will the FDA lift a suspension?
When the FDA determines that grounds no longer exist to continue the suspension they may vacate or modify the order and reinstate the registration of the facility. Typically the reinstatement will be subject to conditions.
The FDA exercised its power of suspension for the first time on November 26, 2012 when it suspended Sunland, Inc.’s peanut mill in Portales, New Mexico.
Products from the facility were linked to an outbreak of Salmonella that sickened 41 people in 20 states.
On January 7, 2013, the FDA reinstated Sunland’s registration after a federal judge entered a consent decree of permanent injunction imposing requirements on the firm.
Sunland can resume processing and distributing raw peanuts from its mill in Portales; however, the company may not resume processing or distributing ready-to-eat food until it completes additional corrective actions.
Stay tuned for Part 2 of Inspections and Compliance coming in Article 5.
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