Chapter 2: The Era of the Food Safety Modernization Act and Hazard Analysis
2.4 What is the Food Safety Plan?
The Era of the Food Safety Modernization Act and Hazard Analysis 25
Similarly, monitoring, verification, and record-keeping activities will be different for the new types of controls considered under PCHF.
• In HACCP, if preventive controls are not properly implemented, a corrective action is required. Under PCHF, there are situations where only a correction (not a corrective action) is needed if the problem is an isolated event that does not directly impact product safety (Food Safety Preventive Controls Alliance, 2016). Corrective actions and correc- tions (with examples) will be discussed in more detail in Chapter 7.
• PCHF Food Safety Plans need to include a supply-chain program that includes documen- tation of preventive controls made in the supply chain before ingredients and products are distributed to a food facility; this is not specified in HACCP requirements, but could be considered part of HACCP documentation and records (control of supply chain may be considered a prerequisite program that would need to be documented in HACCP).
• PCHF Food Safety Plans need to include a recall plan. HACCP does not specifically require a recall plan, although it might be mentioned as part of some corrective action plans under HACCP.
An example of a Food Safety Plan can be found in the public version of the Food Safety Preventive Controls Alliance’s (FSPCA) Preventive Controls for Human Food Participant Manual, which is available for free online (Food Safety Preventive Controls Alliance, 2016).
This document also contains many sample forms and templates that can be used or modified within a Food Safety Plan by a supplier to a retail buyer.
As of August 2016, FDA has begun issuing guidance documents that include information regarding Food Safety Plan content and organization (U.S. Food and Drug Administration, 2016). However, the regulations allow for much flexibility regarding the exact format of Food Safety Plans.
Many examples of HACCP plans are available online and may be of some use for suppliers and as specifications of retail buyers ingredients/products when developing Food Safety Plans (USDA Food Safety and Inspection Service, 2015; Penn State College of Agricultural
Sciences Department of Food Sciences, 2016; University of Wisconsin–Madison Center for Meat Process Validation, 2009). In addition, FDA’s guidance documents on Seafood (http://
www.fda.gov/food/guidanceregulation/ucm2006764.htm) and Juice HACCP (http://www.fda.
gov/Food/GuidanceRegulation/HACCP/ucm2006803.htm) contain much information that may be of use in putting together a Food Safety Plan.
As is the case for HACCP plans, food types or production methods can be grouped together under a single Food Safety Plan if hazards, CCPs, critical limits, required monitoring proce- dures, etc. are similar. This means that a new Food Safety Plan is likely not necessary for every product that a facility produces. However, any features of a plan unique to a specific ingredient, product, or production method (e.g., supply-chain ingredient preventive controls that differ from two different suppliers or ingredient changes that add new hazards to an existing product) will need to be specified clearly within the plan (U.S. Food and Drug Administration, 2013). In addition, since a Food Safety Plan must be reanalyzed every 3 years or whenever a change occurs, there may be some value in maintaining certain plans either combined or separate for your particular organization.
A brief description of each component of the Food Safety Plan follows.
2.4.1 Written Hazard Analysis (21 CFR Part 117.130)
The hazard analysis must be documented in writing. It must identify and evaluate, based on experience, illness data, and scientific reports, known or suspected hazards for the food type being produced. The types of hazards that should be considered include the following:
• Biological hazards (parasites, pathogens, other microbial hazards)
• Chemical hazards (radiological hazards, pesticides and drug residue, natural toxins, decomposition, unapproved food or color additives, food allergens). Radiological hazards previously have not been considered chemical hazards in other HACCP programs and
The Era of the Food Safety Modernization Act and Hazard Analysis 27 could include produce grown in regions known to suffer radiological contamination as an example.
• Physical hazards (stones, glass, bones, metal fragments)
Naturally occurring hazards that either are introduced unintentionally or are intentionally introduced for purposes of economic gain need to be considered. The latter hazards might include, for example, the possibility of melamine contamination since its use could make watered-down milk appear to have the protein content of normal milk. Olive oil diluted with soybean oil could introduce food allergy risks. However, intentional adulteration without a motive of economic gain (for example, possible terrorist motives) would not necessarily need to be included in the hazard analysis nor would intentional adulteration for economic gain that does not introduce risk (for example, honey diluted with high-fructose corn syrup).
The hazard analysis must assess the severity of the illness or injury if the hazard were to occur as well as the probability that the hazard would occur in the absence of preventive controls. It must also consider hazards that might be associated with any part of food production, packaging, distribution, storage, etc., as well as how the food product might be used. If a food product could conceivably be eaten raw instead of cooked (when labeling indicates it should be cooked), new risks might occur; for example, frozen peas, which could harbor L. monocytogenes, typically are not considered “ready-to-eat,” but they might be given to children as “healthy” snacks.
Chapters 3 and 4 of this book discuss hazards that might be considered for manufactured foods, while Chapter 5 provides more detail on conducting a hazard analysis.
An example of a hazard analysis (as well as the other components of a Food Safety Plan) is included within the model Food Safety Plan in Appendix 3 of the FSPCA’s Preventive Controls for Human Food Participant Manual (Food Safety Preventive Controls Alliance, 2016).
2.4.2 Written Preventive Controls (21 CFR Part 117.135)
The written preventive controls must identify and implement preventive controls to provide assurance that any hazards will be minimized or prevented.
Preventive controls should include controls for any CCPs as well as other process controls, food allergen controls, sanitation controls, supply-chain controls, a recall plan, and other controls as necessary.
Chapter 6 of this book provides a detailed discussion of preventive controls.
2.4.3 Written Supply-Chain Program (21 CFR Part 117.405)
A risk-based supply-chain program for raw materials and other ingredients received at a facility is required. The program should include the use of approved suppliers as well as
determine and conduct appropriate supplier verification activities (such as audits, sampling, testing, etc.), and the program must be documented. Supply-chain controls are discussed in Chapter 6.
2.4.4 Written Recall Plan (21 CFR Part 117.139)
A written recall plan must be established that describes the steps to be taken and assigns respon- sibility for taking those steps to notify direct consignees of the food being recalled, as well as the general public, to conduct checks to verify that the recall is being carried out effectively, and to appropriately dispose of the recalled food. Recall plans are discussed in Chapter 6.
2.4.5 Written Procedures for Monitoring the Implementation of the Preventive Controls (21 CFR Part 117.145)
These procedures must be written and appropriate to the preventive control and its role in the food safety program. Monitoring must be done with adequate frequency to provide assurance that the preventive controls are being done consistently, and the monitoring must be docu- mented. Monitoring provides data that can be used in verification activities (discussed in detail in Chapter 8) for the manufacturer and data for the retail buyer to ensure preventive controls are effective during each product production.
2.4.6 Written Corrective Action Procedures (21 CFR Part 117.150)
Written corrective actions that are appropriate to the nature of the hazard and the nature of the preventive control must be established and implemented. The regulations do not specifically identify the types of corrective actions that need to be taken for various hazards to give manufacturers flexibility in how they choose to address them. In addition, the regulations do not specify when corrective actions are needed. Specific situations where corrective actions might be appropriate include the presence of a pathogen in a ready-to-eat product detected during product testing, the presence of an environmental pathogen on a food contact surface detected through environmental sampling, or the detection of an allergen in a product that is supposed to be free of that allergen.
All corrective actions taken need to be documented, including the actions taken to identify and correct the problem and prevent it in the future. A safety evaluation of affected food should be conducted and documented, with details sufficient to demonstrate that unsafe food did not enter commerce (Food Safety Preventive Controls Alliance, 2016). Following a corrective action, the Food Safety Plan should be reviewed and potentially modified to ensure the problem does not occur again.
Corrective actions are discussed further in Chapter 8 of this book.
The Era of the Food Safety Modernization Act and Hazard Analysis 29 2.4.7 Written Verification Procedures (21 CFR Part 117.155)
Verification activities (discussed in more detail in Chapter 8) must include the following:
• Validation that the preventive controls identified are adequate to control the hazard.
(While it may seem confusing to consider validation a form of verification, it may make sense if you realize that until a control itself is shown to be effective, you cannot verify that a hazard is being managed no matter what monitoring or other verification activities are being performed.)
• Verification that monitoring is being conducted as required
• Verification that appropriate decisions about corrective actions are being made • Verification that the preventive controls are being implemented consistently and are
effectively minimizing or preventing hazards
• Verification that the Food Safety Plan is reanalyzed at least once every 3 years