By Joe Famiglietti
The new rule on Preventative Controls for Human Food is mandated by the 2011 FDA Food Safety Modernization Act. Preventive Controls (PC) are steps that a food facility must take to reduce or eliminate food safety hazards. The rule also includes updates to the Current Good Manufacturing Practice (CGMP) requirements such as mandatory training and procedures to control allergen cross-contact. In general, the new rule applies to you if you are required to register with FDA and if you manufacture, process, pack or hold foods. By now, all firms meeting the activities in the prior sentence have to be in compliance with the PC rule unless they are exempt or subject to modified requirements.
Firms covered by the new rule must have and implement a written food safety plan (FSP) and are further required to conduct a hazard analysis in order to identify food safety hazards requiring controls including preventive controls. The new rule requires an appropriate control be developed and implemented that could include process, allergen, sanitation or other controls. When preventive controls are required, the FSP must also include written procedures for monitoring, corrective actions, verification (including validation as deemed necessary) and supporting records, as well as a written recall plan and a supply chain program. The FSP must be prepared or its preparation overseen by a preventive controls qualified individual (PCQI).
If your company is using an existing HACCP program, changes are required in developing a FSP because control need not always be at a CCP (critical control point), but can be handled by a prerequisite program or a preventative control program. For example, allergen cross-contact can be controlled by a written sanitation preventative control program that requires proper cleaning methods be implemented rather than establishing critical limits at a CCP.
The preparation of a proper FSP is crucial, since this is one of the first documents FDA will likely request to see during a PC inspection. There is no standardized or required format for the FSP, but all of the elements as required in 21 CFR 117.126(b) must be in the written document. FDA has published guidance regarding the preparation of a FSP and hazard analysis. See https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UC517391.pdf.
You can expect FDA to arrive unannounced to conduct a PC inspection unless you are located outside of the US, in which case FDA will provide written notice prior to arriving. During the inspection you can expect FDA to carefully review your company’s written food safety programs and to review all required records, such as monitoring and verification records. If deemed necessary, FDA may collect extensive environmental monitoring microbiological samples throughout your facility to determine if pathogens are in the plant environment. If there are positive sample results for pathogens, FDA can require products to be recalled. FDA can also compare the DNA fingerprints of any pathogens found to isolates in the CDC’s database and then require recalls if any matches are identified. If FDA deems your facility as not being compliant, you can expect the agency to take regulatory actions against your firm if voluntary compliance is not taken
You can properly prepare for an FDA PC inspection by considering the following:
Have a written plan covering how your company will handle an FDA inspection that includes a working area for the FDA and that assigns responsibilities for your employees who will be involved in the inspection. You need to have a policy on how to handle any objectionable conditions FDA may bring to your attention and make an attempt to correct any of these conditions while FDA is on-site.
Be sure your FSP is in final form and is signed by your firm’s owner, operator or agent in charge and be sure there is at least one person who is familiar with the overall food safety program who can explain it to the FDA.
Have training records readily available including PCQI training / qualifications, employee sanitation training and records documenting the qualifications all employees including supervisors.
Be sure record keeping is in order and is easily accessible including monitoring and verification records.
If operational or FSP deviations have occurred, be sure appropriate corrective actions have been taken supported by records that must be made available for FDA review.
Be sure your allergen control procedures are in order. All ingredient labels should be reviewed to assure they are accurate and contain all required allergen labeling. Be sure all cGMPs are being followed to prevent unintentional allergen cross-contact issues during ingredient receipt, storage, process, packaging and labeling operations.
Conduct your own environmental monitoring. FDA will likely swab for microbes if you are producing ready-to-eat (RTE) foods that are exposed to the environment prior to packaging. You need to be sure you are conducting an appropriate monitoring program before FDA arrives. If problem areas are identified, corrective actions need to be implemented.
If product testing is used to verify a control, be sure the test is scientifically valid and have corrective action procedures in the event of positive results.
You must conduct reanalysis of the FSP at least once every three years or whenever there is a significant change that effects food safety.
Be sure you have information and records regarding where raw materials are sourced and documentation that the materials are being purchased from approved vendors. It is no longer an option to purchase raw materials from just any source. The new rule requires there must be a supply chain program which includes documentation demonstrating that either suppliers provide safe raw materials, or that another party will apply controls for the hazard.
For food with a hazard requiring a PC, there is now a requirement to have a written recall procedure that includes descriptions of the steps to be taken as well as assigning responsibility for taking those steps.
Conduct or hire an experienced consultant to perform a mock FDA inspection that includes a thorough sanitation audit and review of your programs and records. Conducting a gap analysis audit of your operation will assist in identifying areas that require improvement before FDA finds them.
Be sure all labels being used have been reviewed and approved by a food label expert. In summary, FDA is in full enforcement mode related to the FSMA Preventive Controls regulation. The food manufacturing industry needs to have its food safety program updated to incorporate the Preventive Control provisions. Your PCQI and entire QA staff as well as plant supervisors should be prepared to answer FDA’s questions and demonstrate that you conduct your business in a preventive mode of operation. With proper planning you can have a positive experience from an FDA PC-based inspection and continue to provide consumers with safe foods.