Instances When Preventive Controls May Be Optional

Preventive Controls are risk-based, reasonably appropriate procedures, practices, and processes implemented to significantly minimize or prevent hazards identified during the hazard analysis.

In the previous article, we discussed the basics of Preventive Controls and associated requirements, which include Process Preventive Controls, Food Allergen Preventive Controls, Sanitation Preventive Controls, Supply-chain Controls, and Other Controls.

While preventive controls are a key component of Food Safety Modernization Act (FSMA), there are instances where their implementation may not be required or may be tailored based on specific circumstances.

• One scenario where preventive controls might not be required is when a food facility solely engages in the processing of certain low-risk foods that are deemed unlikely to pose significant safety hazards. For example, facilities handling foods with low susceptibility to contamination or those with inherent safety measures in place might not need to implement extensive preventive controls.

• Another instance where the implementation of preventive controls may be less stringent is in the case of very small businesses. FSMA provides exemptions and modified requirements for qualified facilities, defined as those with less than $1 million in annual sales of human food. Such businesses may have more flexibility in developing and applying preventive controls based on their scale and risk profile.

• Moreover, when a food safety hazard has been adequately addressed through other means, preventive controls may be less emphasized. If a facility can demonstrate that its suppliers have effective preventive controls in place, or if the hazard is controlled through subsequent processing steps, the primary facility may not be required to duplicate preventive measures.

What exceptions and modified options exist for Preventive Controls?

1. Low-risk Food Processing

Low-risk food processing represents a category within the regulatory framework, specifically under 21 CFR Part 117, where the need for preventive controls in a facility is intricately tied to the identification of significant hazards associated with the food being processed. This nuanced approach recognizes that not all food products pose the same level of risk, and facilities handling low-risk foods may be subject to different regulatory requirements.

• Consider a scenario where a processing facility specializes in handling foods that inherently present lower safety risks. These could be foods with natural antimicrobial properties, stable formulations, or processing methods that inherently reduce the likelihood of contamination. In such cases, 21 CFR Part 117 allows for a more tailored and risk-based approach to preventive controls.

• Under Subpart C (Hazard Analysis and Risk-Based Preventive Controls), facilities processing low-risk foods can conduct a hazard analysis to identify and evaluate potential hazards associated with their specific operations. This analysis involves assessing the nature of the food, processing methods, and the likelihood of hazards occurring. If the hazard analysis demonstrates that the food products are indeed low-risk and less likely to harbor safety hazards, the facility may be eligible for exemptions or modified preventive control measures.

Example: For instance, a processing facility dealing with a food product that has intrinsic safety features, such as a low water activity level that inhibits microbial growth, may be exempt from certain preventive controls that would be essential for higher-risk foods. This risk-based approach allows for a more efficient allocation of resources, focusing efforts on areas where they are most needed for ensuring food safety.

2. Exemptions for Very Small Businesses

As per 21 CFR 117.201, qualified facilities with less than $1 million in annual sales of human food may be eligible for modified requirements. Such businesses might be exempted from certain preventive control provisions, while still being required to conduct hazard analyses and document their safety measures. This exemption acknowledges the scale and resources of very small businesses and is outlined in Subpart A (General Provisions).

3. Effective Supplier Controls

Section 117.410 of Subpart G, which pertains to the Supply-Chain Program, underscores the significance of implementing rigorous controls over suppliers. This section acknowledges that the quality and effectiveness of preventive controls at the supplier level can directly impact the safety and quality of the final food product.

Example: For instance, consider a scenario where a food facility sources raw materials from various suppliers. If these suppliers have already implemented robust preventive controls to identify and address potential hazards in their processes, it serves as a critical line of defense against contamination or other risks. In such cases, Section 117.410 suggests that the receiving facility can leverage the effectiveness of its suppliers' controls, potentially reducing the need for redundant or duplicative measures at the receiving end.

• This approach recognizes and promotes collaboration within the food supply chain. Rather than imposing a solely facility-centric approach, it encourages facilities to trust and build upon the preventive measures implemented by their upstream partners. By doing so, not only does it streamline the regulatory burden for the receiving facility, but it also fosters a cooperative relationship between different entities in the supply chain.

• In practical terms, a food facility might engage in transparent communication with its suppliers, requesting documentation and evidence of the preventive controls in place. This could include supplier audits, certificates of analysis, or other relevant documentation that demonstrates adherence to safety standards. By establishing a robust system for evaluating and verifying supplier controls, a food facility can confidently integrate these measures into its own supply-chain program, creating a more efficient and collaborative approach to ensuring food safety.

4. Controlled Hazards through Subsequent Processing

This provision recognizes that the effectiveness of preventive controls can extend beyond the initial stages of food processing. It allows facilities to consider subsequent processing steps as integral components of an overarching preventive strategy to ensure the safety and quality of the final food product.

• Under Section 117.135, which delves into considerations for preventive controls, facilities are required to conduct a comprehensive hazard analysis to identify potential risks associated with their operations. However, this section also acknowledges that certain hazards can be effectively managed and mitigated through subsequent processing stages. In essence, if a hazard is controlled or eliminated during subsequent processing, it may not necessitate additional preventive measures at the earlier stages.

• For example, consider a facility engaged in the production of a ready-to-eat food product that undergoes a cooking or pasteurization step as part of its processing. The hazard analysis conducted in compliance with Subpart C identifies a microbiological risk associated with raw ingredients. However, if the subsequent processing step, such as thorough cooking or heat treatment, is scientifically proven to eliminate the identified microbial hazard, the facility can integrate this step into its overall preventive control strategy.

• In this scenario, Section 117.135 allows the facility to focus on ensuring the efficacy of the subsequent processing step as a critical control point. By doing so, the facility not only addresses the identified hazard but also streamlines its preventive control measures by recognizing the role of subsequent processing in ensuring food safety.

• This regulatory provision encourages a pragmatic and risk-based approach to preventive controls. It emphasizes the importance of understanding the specific processing steps that contribute to hazard control and tailoring preventive strategies accordingly. By leveraging subsequent processing as a means to control hazards, facilities can enhance the overall safety of their food products while optimizing operational efficiency.

5. Additional Preventive Control Exemptions

• Certain facilities, such as warehouses exclusively storing unexposed packaged food, are exempt from hazard analysis and risk-based preventive controls, with the exception of specific temperature controls for refrigerated packaged food that is crucial for safety. Additionally, storage facilities like grain elevators and warehouses exclusively holding raw agricultural commodities (excluding fruits and vegetables) intended for further distribution or processing are exempt from these preventive controls, demonstrating a risk-based approach for different types of facilities (21 CFR 117).

• Moreover, farms and activities of farm mixed-type facilities, fishing vessels, and establishments solely engaged in holding or transporting raw agricultural commodities are exempt from 21 CFR Part 117 Subpart B (GMPs). This exemption is based on an existing provision known as the "RAC exemption." However, off-farm packaging, packing, and holding of raw agricultural commodities, especially if classified as produce, are subject to GMPs or applicable requirements in Part 112. 

• The regulation includes an exhaustive list of farm-related exemptions, applying to activities within the definition of "farm" and specific low-risk manufacturing or processing activities conducted by small or very small businesses on farms for certain foods, provided they are the only activities subject to the registration requirement. This detailed overview highlights the nuanced exemptions and flexibility embedded in FSMA's preventive control regulations.

6. Overall Flexibility with Risk-Based Approach

Throughout 21 CFR Part 117, the regulatory language emphasizes a risk-based approach to preventive controls. The flexibility inherent in the regulation allows facilities to tailor their preventive control measures based on their unique circumstances and risk profiles. Subpart B (Current Good Manufacturing Practice) and Subpart C provide a framework for identifying and implementing preventive controls, with an overarching emphasis on ensuring food safety through a customized, risk-based strategy.

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