Legislative Update

The new preventive control requirements under the Food Safety Modernization Act (FSMA) will have a significant impact on shifting the focus from reacting to foodborne illness to preventing illness from occurring in the first place. The FDA is required to issue a preventive controls regulation by July 2012. It is expected that they will issue a proposed regulation prior to that time. While many of the specifics will remain unknown until the regulation is issued, we can gain a general understanding of what will be required based on information currently available.

As part of the new requirements, registered facilities will have to develop and maintain a written food safety plan (see Figure 1). Registered facilities include foreign or domestic facilities that manufacture, process, pack, or hold food for consumption in the United States. Looking at current requirements for documentation for Hazard Analysis and Critical Control Point (HACCP) programs, the current Good Manufacturing Practices (cGMPs) and the new law provides insight into the likely components of the food safety plan.
 

Food Safety Plan Components:

Likely, a food safety plan will involve a significant amount of documentation, including monitoring procedures and corrective actions, for the following components:

1. Facility Information. Facilities will need to document a description of the food, the methods of distribution and storage, the intended use, and the intended customer for all products produced. Facilities will need to develop a process flow diagram that provides a simple description of the steps involved in processing each product. The flow diagram should cover all steps in the process, including receiving and storage of each ingredient.
 

2. Prerequisite Programs. Facilities will be required to implement prerequisite programs. Each program will be required to have a written plan, established monitoring procedures, established corrective action procedures, and an established recordkeeping system. Specific programs that will likely be required include:

• Personnel: Establish written documents to outline personnel practices, including health and hygiene requirements.
   
• Plant and Grounds: Ensure all areas of the plant are clean and sanitary.
   
• Sanitary Operations (SSOPs): Establish a set of operating procedures to maintain a sanitary environment for the production of food.
   
• Sanitary Facilities and Controls: Ensure all areas of the plant, including restrooms and locker rooms are clean, properly supplied, and designed to reduce the risk of cross-contamination.
   
• Equipment: Ensure equipment is calibrated and functioning properly to mitigate food safety risks.
   
• Production and process controls: Eliminate food safety risks by maintaining control of processes during production that control food safety risks.
   
• Warehousing and distribution: Ensure procedures are in place to ensure sanitary warehousing and distribution of food products.
   
• Allergen controls: Reduce the possibility of cross-contamination between major allergens (peanuts, tree nuts, milk, eggs, wheat, soybean, fish, and shellfish) and non-allergen products.
   
• Environmental monitoring: Control contamination in the processing environment to eliminate food safety risks from environmental contamination.
   
• Product recalls: Ensure the ability to quickly locate and remove recalled product from the market.
   
• Supplier control: Maintain control over food and ingredients by ensuring suppliers are enacting appropriate controls to prevent food safety risks.
   
• Product tracking: Ensure the ability to quickly identify ingredients and finished products, both upstream and downstream, in the event of a public health threat or recall.
   
• Consumer Complaint System: Ensure consumer complaints are captured, analyzed, and appropriately addressed.

3. Hazard Analysis. Facilities will be required to conduct and document a hazard assessment to identify the potential product-related hazards and potential process-related hazards. Complete hazard identification must consider the biological, chemical, physical, radiological, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, unapproved food or color additives, natural hazards, unintentional hazards, and intentionally introduced hazards, including terrorism.

To conduct and document the hazard analysis, facilities should consider using a Hazard Analysis Worksheet developed by FDA for those facilities under HACCP regulations. (Figure 2 shows an example of a Hazard Analysis Worksheet.) An analysis of potential hazards should be conducted for each of the processing steps from the flow diagram. Hazards may be associated with the product or ingredient that is introduced outside of the processing facility or hazards may be associated with the way the product is processed and are introduced within the processing facility. A wide range of documents exists, depending on the product, to assist in identifying and understanding the hazards. Over time, FDA will likely develop commodity specific guidance that will include guidance on conducting a hazard assessment, understanding the hazard, and appropriate preventive controls.

4. Preventive Controls. Once all the hazards have been identified, each hazard must be evaluated to determine the significance of the hazard if it is not controlled, the likely occurrence of the hazards, and if the hazard constitutes a critical control point that must be addressed. Hazards for which, according to the seafood HACCP regulation, "a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur if processed in the absence of those controls" are considered to be significant. The reason for which a hazard was determined to be or not be significant should be documented.

For each processing step where a significant hazard has been identified, the facility must determine and document if a control is required for the hazard at that step (it is possible that hazards may be controlled at prior or subsequent processing steps).

For each critical control point, the facility must establish critical limits: "the maximum or minimum value to which a parameter of the process must be controlled in order to control the hazard." The crucial limit should be at a value where the safety of the product may still be met but before a corrective action would be required. Over time, FDA will likely develop commodity specific guidance that will include suggested control points for product and process specific hazards.
 

5. Monitoring. Each critical control point must be monitored to ensure compliance with the critical limits. FDA suggests that a monitoring program should address what will be monitored, how it will be monitored, how often the monitoring will be done, and who will do the monitoring. While continuous monitoring is desirable, given the diverse nature of processing facilities, it is not always feasible. More frequent monitoring can help provide greater control and limit the amount of product that would potentially need to be removed if critical limits are not met. Facilities should keep a paper or electronic record of critical limit monitoring.
 

6. Corrective Actions and Root Cause Analysis. In addition to conducting ongoing monitoring of controls, facilities must establish and document procedures for taking corrective action in situations where critical limits are not met. Further, documenting the root cause analysis process in a way that demonstrates that the problem is not likely to recur will also be important.
 

7. Verification. Once critical limits and monitoring procedures have been established, Facilities will need to verify that the preventive control and critical limits result in the intended control and reduction of the hazard. Verification will need to be conducted on an ongoing basis and documented.
 

8. Record-keeping. Each facility must establish a record-keeping system to document their hazard analysis, critical control points, monitoring, verification, and corrective action plans and follow-up. The new legislation authorizes FDA to request access to the Food Safety Plan and related documents. It will be critical that facilities have all their ongoing monitoring documentation in a format that they can share with FDA and demonstrate compliance with the preventive controls regulation. These documents will need to be kept for a minimum of two years.
 

9. Re-analysis. Facilities are required to conduct a re-analysis of their food safety plan and hazard assessment whenever they implement significant changes or at least every three years. Significant changes include product, process, or facility changes. During re-analysis, facilities will need to take into consideration product safety data, new developments in science and technology, and any additional information that would impact the hazard assessment and preventive controls available for their products and processes.

These new requirements will have a significant impact on how registered facilities document their hazard assessment, verification, and monitoring activities. Being able to quickly access records, demonstrate compliance with the food safety plan requirements, and prove implementation of a robust food safety program will be critical to maintain a position as a food safety leader. By beginning to think about and plan for the new requirements now, industry will be able to maintain continuous compliance and ensure minimal disruption as new regulations come into effect.

Dr. David Acheson is Managing Director, Food and Import Safety Practice, at Leavitt Partners (www.leavittpartners.com) and former FDA Associate Commissioner for Foods. Dr. Acheson can be reached at dacheson@gie.net.