Scientific Criteria to Ensure Safe Food (2003) / Chapter Skim
Currently Skimming:
3 Food Safety Tools
3 Food Safety Tools
Pages 69-132
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 69... ...
The description of these tools and the discussion of their current or potential uses and applications to enhance food safety have been organized as a progression from the better known to the novel. In addition, the committee strived to circumscribe the material on each tool to that which is relevant to food safety, recognizing that some of the sections, such as "Statistical Process Control" and "The Economics of Food Safety Criteria," are not only foreign to many food processors and food safety regulators, but are technical and scientific fields that only recently have been brought into play in the food safety arena.
|
From page 70... ...
commissioned the Pillsbury Company to manufacture food products for use by astronauts during space missions. The stringent safety requirements imposed on these foods were a reflection of deep concerns in NASA about the potential consequences of foodborne sickness among astronauts in space, as well as of food particles interfering with flight systems (Stevenson and Bernard, 1995~.
|
From page 71... ...
It is noteworthy, however, that an intrinsic weakness of HACCP is that it does not provide information on what these acceptable levels are or a guide on how to set them. Linkage between public health goals and HACCP, through a developing concept of Food Safety Objectives (described later in this chapter)
|
From page 72... ...
Monitoring procedures are then established, and corrective actions are predetermined to be taken if a loss of control is indicated by a deviation from the critical limits. The HACCP plan, along with records demonstrating that the controls at each CCP have performed successfully and have been continuously monitored during processing, are organized for ease of access by the processor and by inspectors from the regulatory agency charged with ascertaining compliance with the regulations.
|
From page 73... ...
The use of quantitative and qualitative risk assessments for biological issues has emerged from the use of quantitative risk assessments for chemical and environmental toxicology (Dourson et al., 2001; IFT, 2002; Neubert, 1999; Paustenbach, 2000~. In simple terms, quantitative risk assessment uses mathematical equations, numerical data, and expert opinion to create a computer simulation of reality.
|
From page 74... ...
Despite the differences in maturity, the overall paradigm of chemical risk assessment has remarkable similarities to the emerging practice of microbial risk assessment. A comparison of key differences and similarities may benefit both fields.
|
From page 75... ...
Historically, this was assessed for chemicals through the use of animal bioassay screens, but now it is largely accomplished using in vitro systems and, recently, by techniques targeted to advances in genomic sciences. Microbial risk assessments are typically initiated in response to a public health concern, and hazard characterization in microbial risk assessment typically uses epidemiological or outbreak data (Escherichia cold 0157:H7 Risk Assessment Team, 2001; Salmonella Enteritidis Risk Assessment Team, 1998~.
|
From page 76... ...
Allocation of resources to fund basic research studies defining these relationships would help to remedy this deficiency. The host side of the dose-response relationship may also be different for microbial and chemical risk assessments.
|
From page 77... ...
It may, however, be possible to use a risk assessment term analogous to the NOAEL for organisms like Staphylococcus aureus or Bacillus cereus that cause illness through formation of a toxin in the food, or for Listeria monocytogenes in healthy adults. Because microbial dose-response assessment does not typically produce a NOAEL, the key point in microbial risk assessment is that for many pathogens there is no safe dose.
|
From page 78... ...
If information is developed later that changes the risk/benefit ratio significantly, FDA may require that the drug be withdrawn from the market. Exposure assessment in quantitative microbial risk assessment (QMRA)
|
From page 79... ...
Therefore, the microbiological risk in ground meat may be expected to be greater than any chemical risk. The same logic could be extended to processing food from multiple sources or to consumption of a contaminated item in a multi-ingredient meal (e.g., vegetables, meat, and sauces)
|
From page 80... ...
Chemical risk characterization involves determining the dose of a chemical that is essentially not harmful to humans, based on the dose-response data from laboratory animal studies and exposure assessments. In contrast, most microbial risk assessments have been undertaken with full knowledge that a particular pathogen is harmful.
|
From page 81... ...
monocytogenes in ready-to-eat foods (FAD/WHO, 2000~. A variety of data gaps have been identified that must be addressed before microbial risk characterization will be as effective as chemical risk characterization.
|
From page 82... ...
The National Residue Program may represent a useful working model on which a national pathogen system could be based. Just as the National Residue Program can be used to validate chemical risk assessments, such a national pathogen program would be invaluable in validating microbial risk assessments.
|
From page 83... ...
Microbial risk assessment may provide the tools needed to help identify the most effective solutions for lowering consumer exposure to foodborne microbiological hazards. In fact, this is the philosophy behind setting microbiological performance standards as a percentage reduction of baseline data that should reduce overall levels of microbial contamination.
|
From page 84... ...
The list of identified data gaps available at the completion of a microbial risk assessment can assist government and industry in targeting funds to generate missing information. If data are not available for part of a food production chain, it may be possible to simplify the QMRA model such that this part of the chain is excluded.
|
From page 85... ...
Table 3.1 provides the relevant quotation from each of these risk assessments. Since the field of microbial risk assessment as applied to food is relatively new, there are few case histories that detail how QMRA can successfully impact
|
From page 86... ...
cold and Data for a a distinct FSIS policy analysis that will identify Risk Risk Assessment feasible risk mitigation options for further Assessment of Escherichia cold comparative analysis." Team, 0157:H7 in Beef 2001 Draft Assessment of "The scientific evaluations and the mathematical CFSAN/ the Relative Risk to models developed during the risk assessment, provide FSIS/CDC, Public Health from a systematic assessment of the scientific knowledge 2001 Foodborne Listeria needed to assist both in reviewing the effectiveness monocytogenes of current policies, programs, and practices, and Among Selected new strategies to minimize the public health impact Categories of of foodborne L monocytogenes." Ready-to-Eat Foods Draft Risk "FDA anticipates that periodic updates to the risk Posnick Assessment on the model will continue to reduce the degree of et al., Public Health uncertainty associated with risk estimates, and that 2001 Impact of Vibrio these updates will assist FDA in making the best parahaemolyticus possible decisions and policies for reducing the in Raw Molluscan risk posed by V
|
From page 87... ...
The action plan attributes the FSIS final rule on shell eggs storage, transportation, and consumer labeling (Salmonella Enteritidis Risk Assessment Team, 1998) and the FDA proposed rule for shell egg safe handling statements and retail refrigeration requirements (FDA, 1999a)
|
From page 88... ...
If one considers the pace with which QMRAs are being conducted around the world, the next decade should provide some interesting examples of their impact on the promulgation of sound science-based food safety policies. FOOD SAFETY OBJECTIVES Food Safety Advances with No Quantitative Measure of Impact on Public Health Historically the major advances in consumer protection have resulted from the development and implementation of selected, targeted control measures at one or more steps along the food continuum.
|
From page 89... ...
Food Safety Objectives and Traditional Microbiological Criteria One approach that could provide this changeable regulatory structure is that of Food Safety Objectives (FSOs)
|
From page 90... ...
Regulatory agencies may find that FSOs represent a useful concept for establishing a theoretical framework to relate performance standards to public health objectives. Conceptually, an FSO would be established on the basis of a quantitative risk assessment of the hazard of interest and would be consistent with the level of consumer protection that the regulatory agency deems appropriate to fulfill the public health objective.
|
From page 91... ...
FSOs can play an important role in modern food safety management by linking information from the risk assessment processes with measures to control the identified risk. As more information becomes available, risk assessments should be updated and FSOs adjusted accordingly.
|
From page 92... ...
Food Safety Objectives and Appropriate Level of Protection The FSO concept was first introduced because of the difficulty in using public health goals (e.g., an ALOP) to establish control measures.
|
From page 93... ...
cold 0157:H7 in products submitted to heat treatment or other processing steps. Food Safety Objectives, Good Manufacturing Practices, Good Agricultural Practices, and HACCP Once an FSO has translated a public health goal into a quantifiable standard, hazard control and monitoring practices must be developed.
|
From page 94... ...
These examples might include slaughter safety objectives, processing safety objectives (analogous to the current Salmonella performance standard) , transportation safety objectives, or retail safety objectives.
|
From page 95... ...
The framework recognizes the wide variety of production, processing, and marketing practices that exist for different foods and can accommodate a range of different risk management options. The monitoring plans required for verifying compliance with the various Safety Objectives should be compatible with the development of Hazard Analysis and Critical Control Point systems, and will provide feedback for the periodic re-evaluation of the public health goals and the specific Safety Objectives needed to achieve these goals.
|
From page 96... ...
Example 2 A performance criterion could be used to limit recontamination and growth of a particular pathogen at any point after processing. Assume that the FSO for a certain potential pathogen in a food product is < 100 cfu/g (see Figure 3.3~.
|
From page 97... ...
o 0.01 to 0.001 0.000 1 FSO . <~' I\ ~ blow FIGURE 3.3 Relating a Food Safety Objective (FSO)
|
From page 98... ...
As is currently done with some performance standards, FSOs also could be used to promote change in an industry and enhance the safety of certain products. Many examples could be cited where epidemiological data have linked certain foods to foodborne illness.
|
From page 99... ...
For example, if one set of FSOs were developed from the USDA Salmonella performance standard for raw meat and poultrywhich allows some level of contamination while another set of FSOs were developed from the FDA Salmonella performance standard for raw seafoodwhich does not allow any contamination these two FSOs for the same pathogen in different products would be different. There are also examples of foods recently regulated by performance standards, such as the 5-D process performance standard for fresh juice and the Salmonella performance standard for raw meat and poultry.
|
From page 100... ...
Another limitation is that the measurements required to define whether an FSO is in fact working are rarely obtained directly. In order to validate or verify that a product meets an FSO or that overall progress has been achieved, the FSO needs to be linked to a contamination level in production, such as a processing safety objective, and that is where the level of contamination should be monitored.
|
From page 101... ...
STRATEGIES FOR DEVELOPING CRITERIA AND PERFORMANCE STANDARDS There are several strategies a regulatory agency can use to develop regulations, and care must be used in selecting the proper one to maximize the efficacy of food safety regulations. This procedure should be a transparent process in the gathering and analysis of data and in the development of the regulations.
|
From page 102... ...
To improve the process of developing regulations, it is important to understand the limitations of each approach and select the best one. Strategies to Develop Food Safety Criteria, Including Performance Standards Laboratory-Based Strategy A statistically valid, controlled-study strategy to develop regulations is one that applies the pure scientific method to develop regulations.
|
From page 103... ...
During the development of regulations, the actual laboratory is the field, and because of limited time and resources, there is often not enough data gathered to ensure statistical accuracy with a known certainty. In addition, it is not known whether the mean and standard deviation of the performance standard or criterion that is measured will remain stable over the period of time the regulation is enforced.
|
From page 104... ...
(A poor performance standard can be defined as either not being effective in meeting the public health objective or generating a needless economic burden to one or more sectors of the food system.) A fourth limitation of this strategy is that the process is rarely transparent to the public, which may then question the validity of the performance standard.
|
From page 105... ...
(FSIS, 2001~. This approach is needed because it is impossible for a regulatory agency to utilize a pure laboratory-based approach in developing a regulation for the field.
|
From page 106... ...
To remedy this lack of flexibility and as previously recommended in the National Academies report, Ensuring Safe Food from Production to Consumption (TOM/NRC, 1998) , Congress should grant the regulatory agencies the legal authority to develop, and the administrative process flexibility to update, food safety criteria, including performance standards.
|
From page 107... ...
When this strategy is used, the regulatory agency must balance the benefits of raising the bar to meet the nation's public health goals with the economic consequences of strengthening the performance standard. Furthermore, flexibility must be incorporated into the development of performance standards so that the regulatory agencies may adjust a performance standard to meet future public health goals; that is, the regulatory structure should allow for review process flexibility.
|
From page 108... ...
These indices provide the regulatory agency with information to determine if the food processor has the capability of meeting the performance standard. The Cpk is calculated when there is both a maximum and a minimum limit specification (i.e., performance standard)
|
From page 109... ...
The regulatory agencies, in turn, must ensure that their professional staff assigned to either inspecting or auditing food-processing plants are appropriately trained so that they can determine if a processing plant is properly using SPC techniques to monitor performance standards and whether the plant is capable of meeting the performance standards.
|
From page 110... ...
The second method is to rely on SPC. This section provides an overview of process control and process control as a tool for use in ensuring food safety, including a comparison between process control methods and the traditional inspection method used to verify compliance with food safety criteria and standards.
|
From page 111... ...
When it is not possible to inspect 100 percent of a production lot, regulatory agencies may establish statistical criteria as an indication of the acceptable level of control of a potential food hazard. An example of this is the low-acid canned food performance standard, which requires an intervention capable of reducing the population of C
|
From page 112... ...
Regulatory agencies, in turn, need to monitor food processors to ensure that this task has been accomplished. Therefore, SPC can be used to show process stability and, once the process is in statistical control, to show whether the process is capable of meeting a performance standard.
|
From page 113... ...
In addition, it is recommended that performance standards link the SPC requirement to continuous improvement. Examples of Other Process Control Approaches Other methods may be appropriate to assure control of food-manufacturing processes.
|
From page 114... ...
Garthright, Center for Food Safety and Applied Nutrition, FDA, October 2002~. In addition to the 5-D pathogen reduction performance standard subsequently established by FDA, producers of raw citrus juices that use surface decontamination to achieve the standard must conduct end-product testing to ensure that generic E
|
From page 115... ...
In conclusion, regulatory agencies should use a science-based approach both to develop regulations and to measure compliance. Performance standards need to be based on appropriate data, to be possible to implement, and to be linked to public health objectives.
|
From page 116... ...
The committee also recognizes the potential benefit that could be derived from the use of SPC principles linked to continuous improvement by food processors, to continually reduce the risk of producing unsafe food products, and possibly also to reduce production costs. In addition, the committee concludes that the most effective procedure to determine whether a food processor is complying with a performance standard is to analyze process and product data using control charts, histograms, and process capability indices; therefore, the committee believes that SPC, linked to continuous improvement, provides a very robust methodology that is easy to monitor from a regulatory perspective.
|
From page 117... ...
may prove to be higher than with process criteria. For companies, performance standards may confer flexibility and reduced costs.
|
From page 118... ...
This echoes concerns stated earlier about the use of generic HACCP plans without a full appreciation of how appropriate these may be for the individual plant, line, and product. The range of food safety criteria discussed in this report includes those that rely solely on performance standards (e.g., 5-D pathogen reduction in juice)
|
From page 119... ...
Issues related to maintaining reductions in pathogens beyond the point or stage of application of a performance standard (e.g., the slaughterhouse or processing facility for meat and poultry) , and to the optimal stages where these reductions were attained, remain understudied in the field of food safety economics.
|
From page 120... ...
. Performance standards lie somewhere in the middle of this continuum and are much less intrusive than process criteria.
|
From page 121... ...
Based on these simple economic principles, the remaining challenge is how to design food safety regulations that help within the framework of risk analysis to link public health goals to scientifically valid and economically feasible performance standards. Risk management clearly serves the role of evaluating alternative food safety criteria to determine if they attain a prestated public health goal.
|
From page 122... ...
. It is important to note that marginal social costs and marginal social benefits may change given the form of a regulation, the particular population and food product under assess
|
From page 123... ...
and the most likely effectiveness (e.g., ability of the process to reduce the presence of a particular pathogen by x logic) and, therefore, on their ability to attain a performance standard (S)
|
From page 124... ...
The following are examples of questions that need to be answered: Has the correct balance of incentives to innovate, benefits, and costs been achieved? From an economic standpoint, are performance standards or process criteria better for food safety?
|
From page 125... ...
with a 10-, 100-, or 1,000-fold increase in sensitivity. Current regulatory standards for foodborne pathogens, in almost all instances, assume use of traditional culture techniques to determine the presence and number of pathogens or indicator organisms in a product.
|
From page 126... ...
Regulations need to be changed to recognize that molecular and other rapid methods can produce results of comparable or greater accuracy than those obtained with traditional culture techniques; there must be provisions in regulatory actions for the use of data obtained with such methods. Any regulatory approaches, including the establishment of performance standards, must have built into them sufficient flexibility to take advantage of the improvements in diagnostics that will almost certainly occur.
|
From page 127... ...
Some of the least-expensive interventions (such as hand washing by food handlers and improving retail worker and consumer compliance with safe food handling and cooking guidelines) are the most difficult to attain because they necessitate changing behaviors of vast numbers of people.
|
From page 128... ...
Presentation to the Institute of Medicine/National Research Council Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food, Washington, DC, April 3. CAC (Codex Alimentarius Commission)
|
From page 129... ...
1998. Lethality and Stabilization Performance Standards for Certain Meat and Poultry Products: Technical Paper.
|
From page 130... ...
1998. Ensuring Safe Foodfrom Production to Consumption.
|
From page 131... ...
Presentation to the Institute of Medicine/National Research Council Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food, Washington, DC, April 3.
|
From page 132... ...
FSIS, USDA. Keynote Address to the CERES Forum On Food Safety Objectives, Washington, DC, December 4.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.