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April 2006
This Chapter will introduce you to intervention strategies designed to immediately correct out-of-control risk factors and to prevent their recurrence. Your program manager can incorporate any of these strategies into your jurisdiction's compliance and enforcement protocol. You can use several of these strategies as suggestions to industry for achieving immediate and long-term active managerial control of risk factors.
Compliance and enforcement are essential elements of a regulatory program and involve all voluntary and involuntary corrections made by the operator. Voluntary corrections by the operator are referred to in this Manual as "intervention strategies." Intervention strategies can be divided into two groups:
Successful intervention strategies for out-of-control risk factors can be tailored to each operation's resources and needs. This will require you to work with the operator to identify weaknesses in their existing food safety management system and consulting with them to strengthen any weak areas noted. Intervention strategies can also be adopted as part of a progressive compliance and enforcement program. Many jurisdictions around the country have successfully used the intervention strategy concept as a "first step" in their compliance and enforcement protocol. If the operator is willing to work with you to gain ownership of food safety, a long-term behavior change will more likely result. This may help reduce the amount of enforcement proceedings that occur as a result of involuntary compliance.
Involuntary compliance results from the following enforcement activities:
Although these enforcement activities are a necessary function in your regulatory work, obtaining voluntary corrections by the operator has proven to be more effective in achieving long-term compliance.
On-site corrections are intended to achieve immediate corrective action of out-of-control risk factors posing an immediate, serious danger to the consumer during the inspection. Usually these violations are "operational" rather than structural and can be addressed by management at the time of the inspection. For example -
Annex 6 provides a full list of suggested on-site corrections for out-of-control procedures found during your inspections.
It is essential to consumer protection and to regulatory credibility for on-site correction to be obtained for any out-of-control risk factors. Obtaining on-site correction conveys the seriousness of the violation to management. Failure to require on-site correction when an out-of-control risk factor has been identified implies that the risk factor has little importance to food safety. If the operation is briefly stopped to address the out-of-control risk factor, the operator may be more responsive to addressing the practices resulting in the out-of-control risk factor in the future. A more favorable impact on future behavior may result that might not have been achieved through discussion alone.
When recommending on-site correction, effective communication regarding out-of-control risk factors is essential and can often be accomplished by -
Although the person in charge is ultimately responsible for the conditions in the facility and should therefore be informed of all out-of-control risk factors, timely training of the food service workers can in many cases have a great impact on future behavior. A translator and/or special training material may be necessary when language or education barriers exist. Remember that while it is important for both the person in charge and food service workers to know why they are having to make a correction, the long-term effectiveness of making the correction may be lost if you are too technical or scientific in your rationale.
During the discussion of inspection findings with the person in charge, you should keep the discussion focused on correction of violations that present an immediate danger to the consumer. Discussion of lesser code violations should be deferred until out-of-control risk factors are discussed and on-site correction is obtained. It is important to point out to the operator that while most basic sanitation problems do not pose a significant threat to the public, foodborne illness caused by out-of-control risk factors often results in significant losses to consumers and the operator. Negligence for not having a strong food safety management system in place to control risk factors can result in financial ruin for even the largest of retail operations.
To assist you in determining the appropriate on-site correction, you should reference your existing regulatory policies and procedures. In the event that your jurisdiction does not have such policies and procedures, your experience and professional judgment will help you to offer the operator practical solutions for bringing the risk factors under control.
In most cases, selecting the most appropriate on-site correction when out-of-control risk factors are observed will be straightforward. For instance, if hamburgers are inadequately cooked, the on-site correction is to continue cooking until the appropriate cooking temperature is reached.
Determining the most appropriate on-site correction of out-of-control procedures such as inadequate hot and cold holding can be very complicated. Since determining on-site correction depends on a number of factors, you may need to conduct a hazard analysis of the food in order to determine the appropriate course of action to take. Annex 6 of this Manual lists the out-of-control procedures that may require a hazard analysis in order to determine the appropriate on-site correction. More information on conducting a hazard analysis is found in Annex 3.
One on-site correction used in the field is reheating. A common misconception is that reheating is a "magic step" for eliminating hazards resulting from improper holding or cooling. If a ready-to-eat, potentially hazardous food is improperly held or cooled, the potential for spore- or toxin-forming bacteria growth increases. Whether to recommend that the food be reheated or discarded depends on a number of factors including, but not limited to -
Although reheating can eliminate vegetative bacterial cells resulting from post-cook contamination (i.e. Salmonella) or from improper holding or cooling (i.e. Clostridium perfringens), it has limitations that must be considered.
Some bacteria form spores that survive cooking. These spores can germinate and grow if food is improperly held after cooking. Bacterial spores are likely to be present in most foods. When a food is expected to contain spores of toxigenic bacteria such as Clostridium botulinum or Bacillus cereus, reheating may be ineffective. The emetic toxin of B. cereus, which has been largely associated with outbreaks in starchy foods, is very stable to heat. While the toxin of C. botulinum may be destroyed with extended reheating, the critical limit for reheating in the Food Code (165 °F for 15 seconds) will not be effective in ensuring the food's safety.
Staphylococcus aureus does not produce spores, only a heat-stable toxin when present in large numbers. Time- or temperature-abused, RTE, PHFs that are touched by bare hands or otherwise contaminated with the organism are at risk.
Neither cooking nor reheating destroys chemical hazards such as ciguatera toxin or scombrotoxin in fish; therefore, fish that are subject to these hazards and are received from unapproved sources or at improper temperatures should be rejected.
Viruses are somewhat resistant to heat and given their low infectious dose may not be reduced to safe levels using the reheating parameters in the Food Code. Therefore, if ready-to-eat food is touched with bare hands, you will need to address several questions in order to make the appropriate on-site correction recommendation, including:
Use these questions as the framework for making a recommendation for on-site correction that is based on current science and your extensive knowledge of the operation. Once you have answered these questions, you should have enough information to determine the likelihood of occurrence of hazards transmitted by bare hands. Remember that viruses may not be destroyed to safe levels by reheating, so if you determine in your assessment that there is a high risk of viral contamination, then discarding the affected food may be the most appropriate recommendation for on-site correction.
When bare hand contact with ready-to-eat food is not observed or when bare hand contact is observed but the risk of viral contamination is low, additional analysis is needed before recommending reheating as an on-site correction for food found out of temperature. In order to properly evaluate the degree of time and temperature abuse and the proper disposition of the affected ready-to-eat food, the following questions should be considered:
The answers to these questions, in combination with observations you make during your inspection, should provide you with enough information to make the appropriate recommendation for on-site correction. If you are still unable to determine the most appropriate disposition of the food after you have conducted your assessment, you may want to consult your supervisor.
As you can see, there is no "catch-all" rule for determining the appropriate on-site correction. Due to the economic hardship that may be involved, it is important for you to base your recommendations on sound science. It is crucial that you have a significant, working knowledge of food microbiology. Your final decision should be based on the best scientific analysis and professional judgment after considering all the information that you have at hand. In some cases, you may even need to consult with other food safety professionals to determine if a food is safe to eat or whether a correction is needed.
While on-site correction of out-of-control risk factors is essential to consumer protection, achieving long-term compliance is equally important. Overcoming several misconceptions about long term compliance will help you in achieving a desirable change of behavior. For example, in jurisdictions using a 44-item inspection report in which only observed violations are marked, it is often taken for granted that if there are no violations marked, the risk factors are being controlled. This is not necessarily true since the observation of code violations is subject to many variables such as the time of day or duration of the inspection. Another misconception is that training alone will result in risk factors being controlled. While training may help, there is no guarantee that knowledge acquired will equate to knowledge applied in the workplace. Another assumption is that enforcement actions such as citations or administrative hearings or on-site corrections will automatically result in future management control. Unfortunately, there is no assurance that any of these actions will result in the long-term control of risk factors.
Long-term compliance may best be achieved through voluntary actions by the operator. If an operator supports the concept that a food safety management system is needed, there is a better chance that long-term compliance will be achieved. The following system components may be used alone or in combination by the operator to provide voluntary active managerial control of risk factors:
Equipment and Layout - Critical limits are difficult to achieve when equipment does not work properly. Proper calibration of equipment is vital to achieving food safety. When calibration is unsuccessful or is not feasible, equipment should be replaced. In addition to equipment malfunctioning, poor equipment layout can present opportunities for cross contamination and must be considered. For example -
Buyer Specifications - Written specifications for the goods and services purchased by an establishment prevents many problems. For example -
Recipe/Process Instructions - Simple control measures integrated into recipes and processes can improve management control over risk factors. For example -
First-In-First-Out (FIFO) - Product rotation is important for both quality and safety reasons. "First-In-First-Out" means that the first batch of product prepared and placed in storage should be the first one sold. Date marking foods as required by the Food Code facilitates the use of a FIFO procedure. The FIFO concept limits the potential for pathogen growth, encourages product rotation, and documents compliance with time/temperature requirements.
Standard Operating Procedures (SOPs) - Following standardized, written procedures for performing various tasks ensures that quality, efficiency, and safety criteria are met each time the task is performed. Although every operation is unique, the following list contains some common management areas that can be controlled with SOPs:
SOPs can also be developed to detail procedures for controlling risk factors:
Risk Control Plans (RCPs) - An RCP is a concisely written management plan developed by the retail or food service operator with input from the health inspector that describes a management system for controlling specific out-of-control risk factors. An RCP is intended to be a voluntary strategy that you and the person in charge jointly develop to promote long-term compliance for specific out-of-control risk factors. For example, if food is improperly cooled in the establishment, a system of monitoring and record keeping outlined in an RCP can ensure that new procedures are established to adequately cool the food in the future. By implementing basic control systems over a period of time (e.g., 60 - 90 days), it is likely that the new controls will become "habits" that continue.
An RCP should stress simple control measures that can be integrated into the daily routine. It should be brief, no more than one or two pages for a single risk factor, and address the following points in very specific terms:
By implementing an RCP, the retail or food service operator will have the opportunity to determine the appropriate corrective action for the identified problem and design an implementation strategy to best suit their facility and operation. Since the RCP is tailored to meet the needs of the establishment, the operator takes complete ownership of the plan and is ultimately responsible for its development and implementation. Your role as the health inspector is to consult with the operator by suggesting ways that the risk factor(s) might be controlled. By creating an RCP, the operator realizes that a problem exists in their food safety management system and commits to a specific correction plan rather than merely acknowledging a single violation. Follow up by telephone or in person indicates to the operator your interest in seeing their plan succeed. This also gives you an opportunity to answer any questions and offer feedback to make the RCP more useful. An example of an RCP, along with a blank template that you can use, is found in Annex 5 of this Manual.
Voluntary Food Safety Management Systems based on HACCP Principles: The Food Code only requires HACCP plans for a few specific specialized processes; however, the development of voluntary HACCP plans is always encouraged. The FDA document "Managing Food Safety: A Manual for the Voluntary Use of HACCP Principles for Operators of Food Service and Retail Establishments" is written for this purpose. A retail or food service operator, in consultation with an appropriate regulatory authority or other food safety professional, can use this document to establish an effective food safety management system based on the principles of HACCP. The document is available from FDA through the following website: http://www.cfsan.fda.gov/~dms/hret2toc.html. Annex 2 contains tables that can be used by industry to develop HACCP plans. The use of HACCP as a food safety management system is discussed in more detail in Chapter 4 of this Manual.
The regulatory inspection provides you with an opportunity to work with an operator to strengthen the existing food safety management system. Regulatory programs can integrate some, if not all, of these risk-based concepts into their compliance and enforcement protocol. At a minimum, you can suggest some of these intervention strategies to retail and food service operators as ways for them to take ownership of food safety by reducing the recurrence of out-of-control risk factors identified during your inspection. Integrating strategies designed to change long-term behavior will be the most effective way to reduce the risk of foodborne illness in a facility.
A list of suggested intervention strategies to achieve on-site correction and long-term compliance for out-of-control procedures is found in Annex 6 of this Manual. The list illustrates the application of intervention strategies in an inspection program.
