Food Safety/Supply Chain Integrity

Question on Sample Retention Under FSMA

The Preventative Controls Rule states:

  • Required records must be retained for at least 2 years after the date they were prepared
  • Records relating to general adequacy of equipment/processes being used by the facility (e.g., results of scientific studies used for validation) must be retained for 2 years after their use is discontinued.

Does this apply to retain samples? Does the FDA have a recommended size and time frame for retain samples?

Answer: The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN) response:

For food products, FDA does not mandate collection and retention of retain samples.  The records requirements pertain only to records that must be established and maintained to demonstrate compliance with the preventive controls rules (e.g., records required in a food safety plan, and records documenting implementation of a food safety plan including monitoring of preventive controls, corrective actions, verification activities, supply-chain preventive controls, and training) were met.

Are registration requirements under the Food Safety Modernization Act (FSM) the same as that under The Bioterrorism Act, or is FDA going to have a second registration process?

Under FSMA the registration is the same as under the Bioterrorism Act however it has changed in the sense that it must be renewed. When the BT Act was passed, registration was originally a one-time requirement.  FSMA amends that provision and requires facilities to re-register every 2 years. The statute specifies that the re-registration period is between October 1 - December 31 every other year.  We expect that the re-registration obligations will begin in 2012, but FDA hasn’t announced specifics yet.  If a company registered under the BT Act, they will need to re-register every 2 years going forward. FSMA’s language modifies FFDCA section 415(a) (the Bioterrorism Act registration provision.

Does the Food Safety Modernization Act in any way dilute the protections of the Bioterrorism Act provisions that safeguard formulas, or does it require disclosure of ingredient concentrations?

The existing formula protections in the Bioterrorism (BT) Act are not affected by the new law.  The Food Safety Modernization Act (FSMA) amends the BT Act to provide FDA with access to: "[A]ll records relating to such article, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals."  Essentially, this just expands the scope of the existing access to additional food products (e.g., other foods made on the same line).  However, it does not affect the existing protections in the BT Act. Under the BT Act, the records access provisions are expressly limited such that they do not extend to "recipes for food." With the addition of the new language, access would still be limited in such a manner so that formulas are still protected.

Does FDA have an emergency number should I ever need to get in touch with someone after hours about a supply chain issue?

Yes.  The U.S. FDA recently reported the new numbers for the Office of Emergency Operations at 1.866.300.4374 or 301.796.8240.  These numbers can be used to report a serious, life-threatening event involving FDA-regulated products including food and dietary supplements.