The Food Safety Modernization Act (FSMA) was enacted on January 4, 2011, affecting every step of the food supply chain, and shifting the focus from reacting to food safety crises to preventing them.

Generally, foreign and domestic facilities that manufacture, process, pack, or hold food for human consumption in the United States must register with FDA and are subject to FSMA requirements, specifically the Preventive Controls Rule for Human Food unless an exemption applies.  This rule dictates the requirements for Current Good Manufacturing Practice (CGMPs), the Food Safety Plan and Supply Chain Program.

The CGMPs were updated and changed from guidelines to binding requirements under FSMA. The rule also requires that a Preventive Controls Qualified Individual (PCQI) must develop or oversee the development and implementation of a facility’s food safety system.

Facilities that engage solely in the holding or storage of unexposed food, are exempt from certain requirements.

Keep reading for an overview of how FSMA applies to food facilities, including those that solely engage in the storage of unexposed food.

CGMPs

All food facilities must follow the CGMPs. As mentioned above, FSMA updated the CGMPs. Previously, the CGMPs were found in 21 CFR 110 but the “new” CGMPs are now under 21 CFR 117 Subpart B. Given new challenges, technological advancements, and changes in the food processing industry it was necessary to re-assess and modify the CGMP requirements.

The CGMPs address the basic elements for handling food under sanitary conditions and to prevent its contamination and adulteration. Implementing proper CGMPs provides a solid foundation for an effective food safety system. Areas addressed under the CGMPs include but are not limited to:

• Personnel hygienic practices and training
• The conditions and maintenance of the plant and grounds including equipment and utensils
• The safety of the water used for production and for cleaning
• Sanitation principles and practices to maintain cleanliness and prevent contamination and allergen cross-contact
• Proper storage of raw materials and foods to prevent their contamination or the proliferation of microorganisms, among others.

One of the main issues addressed by FSMA under the CGMPs is the need for personnel training. Training is critical to implementing an effective food safety system. A facility is required to have qualified employees who have the education, training and/or experience or a combination thereof to perform their assigned duties. Not complying with CGMPs account for most of the observations during FDA food facility inspections.

Food Safety Plan and Supply Chain Program

FDA requires most food facilities to have a written Food Safety Plan that identifies and evaluates known or reasonably foreseeable biological, chemical, and physical hazards associated with a product and process. For significant hazards identified, preventive controls must be identified and procedures for their implementation must be established.

When your suppliers are controlling certain hazards in the raw materials, ingredients, or food received, a Supply Chain Program must be implemented to monitor supplier’s practices and ensure the hazard(s) they are responsible for are adequately controlled. However, 21 CFR 117.7 states that facilities solely engaged in the storage of unexposed packaged food, are exempt from the Food Safety Plan and Supply Chain Program requirements. If the food requires time/temperature controls for safety, modified requirements pertaining to time/temperature monitoring and records apply

Modified Requirements for Time/Temperature-Controlled Storage

When a facility is solely engaged in the storage of unexposed packaged food that requires time/temperature controls for safety, they must establish and implement temperature controls that significantly minimize or prevent the growth of, or toxin production by pathogens during storage.

Monitoring temperature and calibrating temperature recording devices or equipment procedures must be performed at an adequate frequency to ensure the temperature controls are adequately performed and if a loss of control is discovered, appropriate and prompt corrective actions are taken to resolve the issue, evaluate the safety of the food, and prevent it from entering commerce if its safety was affected. Relevant records pertaining to the temperature controls’ monitoring, calibration, verification, and corrective actions must be kept for at least 2 years after the date they were prepared and made promptly available to FDA upon oral or written request.