Preventive Controls (PC) is a food risk management system developed by the FDA Food Safety Modernization Act (FSMA) back in 2011. Preventive Controls is to serve as steps to remove, eliminate, or reduce any food safety hazard. Although that Preventive controls falls under a Food Safety Plan (Hazard Analysis, Preventive Controls, Risk-based Supply Chain Program, and Recall Plan), PC also has 4 specific controls that would controls specific areas of the production:
- Process Preventive Control: Process control is included in any process of your product that needs a value or critical limit to maintain the food's quality. Some examples of values may include refrigerating, cooking, and possibly acidifying. A process control must have a scientifically validated method that helps demonstrate that the food safety control will manage the hazard.
- Food Allergen Preventive Control: The eight most common allergens are: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. With this, producers need to be sure there is no cross-contamination within the operation. You also need to take all appropriate measures to ensure that allergens are accurately declared on the food product label.
- Sanitation Preventive Control: Some food operations may not have a known processing step that will remove or reduce a risk. Therefore, a significantly heightened activity may be needed to clean and sanitize certain facility areas and/or production equipment. This step helps minimize the hazards from surfaces and the environment. Sanitation controls include a written standardized procedure (SOP) with a monitoring activity to confirm that the cleaning and sanitizing were conducted appropriately and a record to demonstrate that the activity was completed.
- Supply Chain Preventive Control: Some food product operations may have a hazard that they are not able to control in their process. Therefore, more scrutiny from where they source their raw materials may be required. A supply chain preventive control means the processor uses supporting documentation from their supplier as the control. These supplier records demonstrate that the supplier properly managed the hazard.
With any regulation, there are components that would be needed to be followed. It is required to have employees be trained in food hygiene, food safety, as well as other facility trainings to operate (21 CFR 117.4). Current Good Manufacturing Practices (21 CFR 117 Subpart B). Also, the facility will need to comply along with the food safety plan such as conducting and identifying hazards in a hazard analysis, monitor and verification, correction, and record keeping (21 CFR 117 subpart C).
Attestation and Exemptions for "very small businesses"
Attestation is a written statement by the processor verifying that the contents are formally certified or witnessed. Issuing an attestation to the FDA for your facility means that your business is in compliance with non-federal food safety laws and regulations or is capable of integrating preventive controls to prevent any hazards with its foods (21 CFR part 117 subpart A, B, C, D, E, F, G and 21 CFR part 507 subpart A, B, F).
To do so, you will need to attest to FDA's Form 3942a (for human food as 3942b is for animal food) attesting to two claims. First, the facility must be defined as a "qualified facility." Second, that your production adheres to the state/local/county non-federal food safety law based on licenses, inspections, permits, certifications; or that you have identified and prepared preventive controls that will be monitored to ensure control of effectiveness.
We advocate for each business to develop and implement a food safety plan as a best practice, and it is required for processors covered under the PC rule. However, fully written food safety plan exemptions are allowed for a "very small business" instead of a "qualified facility."
If you are a "very small business," you will still need to attest to FDA's form (3942a/3942b) as there will be a section for your exemption. Please note that being a "very small business" does NOT mean that you are exempt from the second section of complying with non-federal food safety laws and regulations or is capable of integrating preventive controls to prevent any hazards.
Not sure if you are exempt? Check out PennState’s Coverage and Exemption Tool!
© Copyright 2020 MDAR Food Processors Resource Guide. Contents of this subpage has been reproduced from and with permission of MDAR.
Preventive Controls is NOT HACCP
Although preventive controls and HACCP are similar, they serve different purposes as well as have different terms and methods to their food management systems. HACCP covers juice, seafood, dairy, meat, poultry, and a few other special conditions products. As for preventive controls covers the remaining food products. You can check out, Table 1: Quick Guide of Food Product Regulations Requirements, for a better visual of what certain regulations are covered.
As for the difference of terms and methods, below is a table to easily visualize the the controls and monitoring methods that each provides.
Critical Control Points (CCPs)
Parameters & Values
Corrective Action or Corrections