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8 Overall Findings and Recommendations The U.S. food safety regulatory system has developed over a period span- ning more than a century. The regulatory focus has shifted from an overriding concern about filth and fraud to issues regarding food safety as it relates to wholesomeness and control of contaminants, particularly those of chemical and microbiological origin. Because the regulatory authority for food is divided among several agencies and is based on legislation enacted under the technical, societal, and political circumstances of the times of their enactment, there are vast differences in the regulations being applied to various food groups and in the way the agencies interpret and enforce such regulations. These differences in the regulatory framework, together with the differences in origin, processing, and characteristics of the food groups selected for the study, explain the committee's decision to discuss and evaluate the current safety criteria individually for each food group. However, the committee also recognizes that there are issues regarding the establishment of food safety criteria that are common to all food groups being studied that should be addressed separately from those specific to each selected food group. Although most issues regarding policy were intentionally excluded from the individual commodity discussions, the committee considered some policy issues closely related to the success of scientific criteria. Thus, the com- mittee concluded that the authority of regulatory agencies to enact and enforce food safety criteria within the current regulatory system, and the effectiveness and consistency of such enforcement, were inextricably linked to its charge and needed consideration. In addition, discussions regarding the need to regulate food safety based on science and to link food safety criteria to overall public health 248

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OVERALL FINDINGS AND RECOMMENDATIONS 249 objectives were so central to the committee's charge that these issues constituted the core of the discussions. THE NEED FOR REGULATORY AGENCIES TO HAVE THE AUTHORITY AND FLEXIBILITY TO ENACT, ENFORCE, AND UPDATE FOOD SAFETY CRITERIA During its deliberations, the committee concluded that legal challenges to actions taken by regulatory agencies in response to violations of established food safety criteria have cast doubt on the authority of the agencies to enforce some current criteria (e.g., performance standards). While the committee did not under- take an analysis of the merits of these challenges, it concluded that the doubts created by these challenges should be promptly addressed through Congressional action. . Congress should give regulatory agencies the clear authority to estab- lish, and enforce compliance with, science-based food safety criteria, including performance standards. Furthermore, the committee concluded that the current process to modify existing food safety criteria is too rigid to allow appropriate and timely updating of these regulations to keep up with the fast pace of scientific and technological progress. Congress should give the regulatory agencies the flexibility needed within the administrative process to update food safety criteria, including performance standards, so that new scientific knowledge and technological innovation can be timely incorporated in an effi- cient manner into these regulations. This flexibility is needed to incor- porate new processing or assessment techniques and to allow the agencies the ability to change performance standards to align them with the best contemporary scientific knowledge. LINKING FOOD SAFETY CRITERIA TO PUBLIC HEALTH OBJECTIVES The committee concluded that defining the means to measure the effective- ness of a new regulation is an essential factor for consideration during its devel- opment. . Any food safety criterion should be coupled with some sort of veri- fication measure so that the effectiveness of the criterion can be assessed.

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250 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD Food safety criteria have the common objective of protecting or improving public health. Therefore, the committee concludes that science-based food safety criteria must be clearly linked to the public health problem they are designed to address. To accomplish this, a cause/effect relationship needs to be estab- lished between contaminants in foods and human disease, that is, to allocate the burden of foodborne disease among foods and food groups. Knowing the contri- bution of each food or food group to this burden would allow the selection (or promote the development) of appropriate interventions and set the basis for estab- lishing criteria such as performance standards. This knowledge would also allow regulators to (1) focus on those foods that present the highest risk, and (2) target effective interventions at Critical Control Points (CCPs) in the production, pro- cessing, and distribution continuum of such foods. Moreover, such a link would allow the regulatory agencies and industry to measure the effectiveness of the selected interventions, and corresponding criteria, such as performance stan- dards, in controlling the particular hazard and thus improving public health. . Congress should require the development of a comprehensive national plan to harmonize the foodborne disease surveillance that is con- ducted by public health agencies with the monitoring of pathogens across the food production, processing, and distribution continuum that is conducted by food safety regulatory agencies, and allocate the funds to develop and implement this plan. This plan would aim to establish the burden of foodborne disease and would be a concerted effort between public health and food safety regulatory authorities. . . To implement such a plan, Congress should allocate funds to expand the current foodborne disease surveillance programs such as FoodNet, PulseNet, foodborne outbreak reporting and data sharing, and other national foodborne disease surveillance systems conducted by public health authorities. In addition, Congress should allocate funds for the food safety regulatory agencies to establish and maintain databases on pathogen contamination at various stages in the production/consumption con- tinuum of domestic and imported foods and food groups frequently associated with foodborne disease. This effort should include studies to characterize the points in the production/consumption continuum of such foods where contamination is most likely to occur, so that the limited current knowledge of the microbial ecology of pathogens and cross-contamination pathways may be advanced. This knowledge will be the basis to identify CCPs that would serve to achieve a particular public health objective.

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OVERALL FINDINGS AND RECOMMENDATIONS DEVELOPING AND MONITORING SCIENCE-BASED FOOD SAFETY CRITERIA 251 An executive order exists that requires regulatory agencies to develop food safety criteria based on science. The committee recognizes that a first major step in this direction has been the introduction of the Hazard Analysis and Critical Control Points (HACCP) system in various areas of the food industry. The committee strongly recommends that the regulatory agencies continue to introduce and audit the implementation of HACCP in all sectors of the food industry, as appropriate. HACCP The committee concluded that the positive balance of progress in food safety after implementation of HACCP, as measured by overall reductions in several major foodborne diseases, is a tribute to the efforts of industry and the regulatory agencies to improve food safety. This progress confirms the committee's belief that industry and food safety regulatory agencies alike must continue to focus on prevention, reduction, or elimination of foodborne hazards along the food continuum through a science-based food safety assurance system. However, the committee also recognizes that there is still much to be done con- cerning the way HACCP is being implemented by industry and the way compli- ance with established criteria is being enforced by the agencies. Among the problems being encountered in HACCP implementation, the committee con- cluded that inadequate HACCP plan specificity for a given operation, in some cases, may be the root of certain miscommunications and problems in complying with HACCP regulations. There is also inconsistency in the approach taken by the U.S. Department of Agriculture (USDA) and the Food and Drug Administra- tion (FDA) regarding HACCP implementation. This should be addressed. . Continued training in HACCP principles to assure proper implemen- tation by industry personnel and consistent interpretation and moni- toring of compliance by inspectors from the regulatory agencies is necessary. In addition, the committee recognizes that one of the longstanding limita- tions of HACCP is that the actual level of hazard control may not be clearly stated in the HACCP plan. That is, there is little or no guidance on the level of hazard control expected in an adequately designed and implemented HACCP plan because the "acceptable level" to which a hazard must be reduced at a CCP is undefined by HACCP. The committee concludes that, as currently done with certain performance standards, use of the evolving Food Safety Objective (FSO)

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252 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD concept could, in some cases, help remedy this problem by clearly defining the level of control needed for adequate Good Manufacturing Practices (GMP), Pre- requisite Programs, and HACCP systems. Strategies for Developing Science-Based Food Safety Criteria Regarding the strategies available to the regulatory agencies to develop science-based food safety criteria, the committee concludes that it is seldom possible for regulators to base new regulations strictly on laboratory data or using only expert opinion. Recognizing that it is impossible to fill all data gaps, the committee recommends that regulatory agencies use a strategy that combines the use of the best available data and the best expert judgment as an appropriate, science-based means to establish food safety regulations. The process described above would have a high degree of transparency and provide an appropriate strategy to establish regulations in a timely manner. The committee emphasizes that transparency that is, effective communication of the underlying reasons for establishing food safety

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OVERALL FINDINGS AND RECOMMENDATIONS . 253 control measures, as well as the expected outcome of these measures, to all stakeholders greatly contributes to acceptance of the mea- sures. In addition, to maximize transparency in developing new food safety regulations when limitations in data occur, transparency should include documenting the limitations of the data, describing the assumptions used to fill in the data gaps, and making this information available to the public. This process should actively involve the best scientists in the field. Similarly, for flexibility, the committee recommends that the regula- tory agencies periodically evaluate and update food safety criteria. To this end, Congress should enable regulatory agencies to incorpo- rate flexibility into the administrative process, so that these criteria can be adjusted efficiently to meet future public health goals. The Pasteurized Milk Ordinance and the Conference for Food Protection pro- vide models of a specific structure and mechanism for biennial review of existing regulations. The committee also discussed what constitutes appropriate data to support the development of science-based food safety criteria. There are several ways through which regulatory agencies may obtain appropriate data: . Regulatory agencies can conduct or fund pilot studies or risk assess- ments, or collect appropriate data if these data are not available. Regulatory agencies should develop and maintain databases on the prevalence of specific contaminants for critical commodities. Congress should provide adequate resources to develop and maintain these databases. Chapters 2, 4, and 6 describe the particular need and justification to maintain current databases on major food groups, or to develop new ones. In addition to maintaining these databases, regulatory agencies must continually analyze these data using basic time series analyses, techniques that are standard in Statistical Process Control (SPC) methods. The committee also discussed a number of critical issues that must be addressed and controlled to ensure good analytical results whether the data are collected for monitoring purposes for baseline development or for verification purposes. Ensuring that validated testing and monitoring methods are used is essential when developing standards or for verifying processes. The committee recognizes that consideration of unique methodology issues is necessary when "zero tolerance" is used as a performance standard. The con- cept of a zero-tolerance performance standard is inextricably linked to the sensi- tivity of the method employed to detect the offending hazard, as well as to the sampling strategy employed. Sampling protocols must take into account that a

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254 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD large sample is needed to ensure the absence of the hazard, and that the sample must be representative of the material being tested. There are various tools that would facilitate the development of science- based food safety criteria or their implementation and monitoring within a HACCP system; these tools are described below. Risk Assessment Among the food safety tools discussed by the committee, microbial risk assessment was deemed to offer a systematic approach to estimating the impact of pathogenic microorganisms in the food chain. Microbial risk assessment may help find the most effective solutions for lowering consumer exposure to foodborne microbiological hazards. Microbial Risk Assessment is rapidly evolving into a major scientific methodology on which to base food safety criteria. However, the committee emphasizes that defining microbial dose-response relationships for foodborne pathogens is essential if more accurate microbial risk assessment results are desired. Allocation of resources to fund basic research studies defining these microbial dose-response relationships would help to remedy this deficiency. Data on microbial cross-contamination rates suitable for quantitative risk assessment are only now starting to become available. Precise localization of where such cross-contamination occurs would require multiple sampling points in the food production system. The committee calls on USDA and FDA to undertake or fund studies to characterize the points in the food continuum where control may be most effective and could have the greatest impact on reducing foodborne disease for food-pathogen combinations where insufficient knowledge has prevented intervention. The committee recognizes that no data from a system analogous to the National Residue Program exist for use in microbial risk assessments, and con- cludes that a national residue system may represent a useful working model on which a national pathogen system could be based. Just as the national residue system can be used to validate chemical risk assessments, such a national pathogen system would be invaluable in validating microbial risk assessments. Various other data gaps have been identified that must be addressed before microbial risk characterization will be seen to be as effective as chemical risk characterization. However, the committee recognizes that when data are not available for part of the food production chain, there are strategies such as the use of predictive models, the use of surrogate data, stochastic simulation using proba- bilistic distributions, and the use of expert opinions and consults (sometimes referred to as qualitative risk assessment), to fill such data gaps.

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OVERALL FINDINGS AND RECOMMENDATIONS 255 Data gaps should not prevent a risk assessment from being initiated, completed, and serving a useful purpose. However, these data gaps must be communicated to those requesting the microbial risk assess- ment, so that they will be aware of its limitations. The inherently iterative nature of risk assessments allows continual updating as more and better quality data become available, thereby increasing their effec- tiveness as tools for policy making. Food Safety Objectives The committee examined another evolving food safety tool, the Food Safety Objective (FSO) concept. 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 could 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. This concept may be useful to regulators in developing performance standards for application at the processing plant level (processing safety objective) such that an appropriate level of protection against a hazard is achieved in a food product at the time it is consumed. FSOs may also be useful to industry in selecting interventions that would ensure that the FSO is achieved, and to the regulators in monitoring compliance with criteria such as performance standards. FSOs are important because they enable translation of public health goals into measurements that food processors are directly able to effect. This is a novel approach that may allow regulators to close the gap left by HACCP when it defined a CCP as any point, stage, or step along the food production/processing/distribution continuum where a hazard can be prevented, eliminated, or reduced to an acceptable level, but left the acceptable level undefined. An FSO provides the basis for defining this level. The committee recommends that regulatory agencies examine the potential application of the FSO concept when appropriate. 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. Thus, the committee con- cludes that the FSO concept may be a useful tool for developing policies that are consistent with current science and could offer an alternative approach to food safety management focusing on the protection of human health, while offering flexibility in achieving that goal.

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256 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD Statistical Process Control Because manufacturing processes tend to vary over time, processors and regulators determine compliance with a performance standard either through end-product testing or process control. Because most food product testing is destructive, food processors and regulators use acceptance sampling when testing rather than 100 percent inspection. Acceptance sampling assumes that the product characteristic that is being measured exhibits relatively stable variation; thus, it is not designed to identify "hot spots" (i.e., when microorganisms or toxins are concentrated in a very small portion of the lot), sporadic food safety hazards, or food hazards that occur at very low levels in a production lot scenarios that are likely to occur with many foodborne microbial hazards. Although end-product testing by itself does very little to improve the safety of individual batches of food, microbiological testing has an absolutely critical role to play in HACCP plan verification and verification of scientific criteria. The committee recognizes the value of SPC as a scientific method that can help the processor to improve the process and the regulator to ensure compliance with food safety criteria. Processors may use it to verify control of a food-processing system and to provide information that can be used to critically examine the system so that appropriate actions can be taken to reduce the likeli- hood of manufacturing unsafe food products. 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 believes that for regulators, 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. SPC, linked to continuous improvement, provides a very robust methodology that is easy to monitor from a regulatory perspective. Therefore, the committee concludes that food safety regulations should incorporate the concepts of SPC linked to continuous improvement, and they should require that food processors analyze and maintain records to ensure that their processes (1) exhibit stable and predictable variation, and (2) are capable of meeting performance standards. The regulatory agencies, in turn, must ensure that their professional staff assigned to inspecting or auditing food-processing plants are trained to enable them to determine whether a processing plant is properly using SPC techniques to monitor performance standards and is capable of meeting the performance standards. . The committee recommends the adoption of SPC principles linked to continuous improvement by food processors, as well as incorporation of such principles by the regulatory agencies into food safety regula- tions and into the agencies' compliance monitoring procedures of food processors.

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OVERALL FINDINGS AND RECOMMENDATIONS Food Safety Economics 257 The committee recognizes that the bulk of current food safety economics research has not focused on the impact of individual performance standards iso- lated from overall food safety policy or program (mostly HACCP-based regula- tions). Therefore, the committee concludes that, at present, it is difficult to quantify the unique costs and benefits of particular performance standards implemented as part of a broader regulatory change. In order to complete such evaluations it would be necessary to have representative, detailed cost data linked to actual improvements solely due to the particular performance standard under review. Research in this area is needed. New Diagnostic Tools Modern regulatory systems depend on technology to detect deviations from regulatory criteria. Rapid advances in the field of diagnostic technology under- score the committee's belief that there is a need for flexibility in any food safety regulatory approach and development of performance standards. Currently, there is a perception on the part of regulatory agencies that identification of a pathogen for regulatory purposes is not "real" unless a microorganism is isolated. Regulations need to be changed to recognize that molecular analytical methods and other rapid methods can produce results of comparable or greater accuracy than those obtained with traditional culture techniques, and there must be provision for the use of data obtained with such methods in regulatory actions. Any regulatory approaches, including the establishment of performance standards, must have built into them sufficient flexibility to take advantage of the improve- ments in diagnostics that will almost certainly occur. The committee points out that there are limits to what science can deliver. While science will continue to search for and discover answers to problems involving foodborne illness, inexpensive answers are often unavailable or im- practical. Where to draw the line between reasonably cost-effective requirements that should be implemented and those that would be beneficial but would have too great an impact on food prices is a question for politics rather than science. SCIENTIFIC CRITERIA IN MEAT AND POULTRY, SEAFOOD, PRODUCE, AND DAIRY PRODUCTS The committee, through its two subcommittees on meat and poultry and on seafood, produce and related products, and dairy products, examined the main safety criteria, including performance standards, currently applicable to each one

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258 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD of the sectors of food processing selected for consideration in this report. In so doing, the committee answered specific questions posed by USDA and FDA in their respective charges to the committee, as described in the following sections. Safety Criteria for Meat and Poultry The Approach to Meat and Poultry Safety Under the Federal Meat Inspection Act and the Poultry Products Inspection Act, the USDA, through its Food Safety and Inspection Service (FSIS), inspects all domestic meat and poultry to be sold in interstate commerce in the United States. It also inspects plants that export meat or poultry to the United States. In addition, there are 27 states that operate state meat and poultry inspection pro- grams. All of these plants operate under a HACCP system. Microbiological testing of product samples obtained by the federal and state programs is conducted at USDA-approved laboratories. The committee notes that these are lagging indicators of process performance by meat or poultry plants because samples are taken after the product is prepared and packaged and, even with rapid methods, there is a significant lag time between the collection of the sample and the analysis of the laboratory data. Although microbiological samples provide both the plant and regulatory agency with a "score card" for plant performance, if further significant gains in the safety of the U.S. meat and poultry supply are to be realized, meat and poultry establishments need to implement more effective process control measures. As mentioned earlier, these process control measures should be linked to a systematic continu- ous improvement process to achieve the necessary level of safety demanded by the U.S. consumer. In addition, the committee concludes that the regulatory enforcement of HACCP and associated microbiological performance standards must be conducted adequately and in a timely manner if it is to achieve its goal of reducing microbial contamination of raw meat and poultry products and, hence, of improving public health. Raw Meat and Poultry Process Control Criteria The committee concurs that there is general agreement within the scientific community that generic Escherichia cold is likely the best indicator of fecal contamination of carcasses. In addition, the committee deems that the FSIS ratio- nale used in developing the generic E cold process control criteria for raw meat and poultry made reasonable assumptions and proceeded in a logical fashion. However, in some instances, the committee notes that if the populations of generic E. cold are extremely low, the testing may no longer be providing the valuable information that would allow the processor to continue making improvements in the process.

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262 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD Lethality: Standards for the Production of Certain Meat and Poultry Products The committee deemed that the FSIS approach in developing this standard was not scientifically justified and has resulted in an excessively conservative performance standard. Also, in examining the safe harbor treatments allowed for use by processors who cannot or do not wish to validate their own treatments, the committee expressed concern about the need to ensure proper adaptation of such treatments to the particular processor's HACCP plan. Stabilization: Performance Standards for the Production of Certain Meat and Poultry Products The committee considers the method used by FSIS to achieve the specified reductions in Salmonella in ready-to-eat poultry and beef products confusing and hard to use in determining the validity of either the data or the assumptions made in setting this standard. Therefore, the committee did not critically review this performance standard or assess the validity of the assumptions made during its development. The committee points out that this case illustrates the need for greater transparency in the development of food safety criteria, as mentioned earlier. This directive does not cover cured meat products but is being universally applied to them by inspection personnel. Animal Drug Residues The committee recognizes that regulatory review of the use of drugs in food animals is continuing. The committee concurs that the approved tolerance level constitutes the performance standard for those chemicals that are used in animals and have such a tolerance level. Sanitation Standards The committee concludes that, although described as "standards," the actual language in the sanitation regulations includes numerous references to "adequate," "preventing sources of adulteration," and "sufficient." Therefore, these regula- tions provide little in the way of a descriptive and objective "standard" and are better characterized as "guides." Economic Cost-Benefit of the Pathogen Reduction/HACCP Rule As mentioned earlier, the committee concludes that more research is needed before a proper cost-benefit analysis of specific food safety criteria can be isolated from the general effects of a wider regulation such as the Pathogen Reduction (PR)/HACCP rule. However, the committee points out

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OVERALL FINDINGS AND RECOMMENDATIONS 263 that future economic impact assessments of such regulations, when considering the effectiveness of novel interventions, should rely on data gathered at the pro- cessing plant level and not only from laboratory or theoretical assessments. Additional Approaches to Reduce Microbial Hazards in Meat and Poultry The committee considered the need to move toward an integrated approach to meat and poultry safety. It concluded that efforts to reduce preslaughter contamination are likely to be an important part of a comprehensive, farm-to- table food safety strategy, not only to reduce pathogen load at the slaughter plant, but also to prevent the hazard from direct contact with infected animals, from runoff from feedlots and farms, and from contaminated water supplies. The committee recommends that USDA conduct or fund research on the role of nonfecal carriage and commingling prior to and after slaughter to elucidate the factors that contribute to the microbial contamination of live animals, carcasses, and products. The committee also recommends a research focus on intervention trials at all stages of the production process of meat and poultry products. This is consistent with the committee's view that industry and the regulatory agencies should continue to place greater emphasis on contamination prevention rather than relying on inspection and end-product testing to ensure the safety of meat and poultry. Safety Criteria for Seafood There are currently over 350 species of fish that are commonly consumed. This diversity is expressed as a broad spectrum of sensory attributes, product forms, and preparations that are particular to seafood. Seafood presents unique safety concerns that arise from both the intrinsic characteristics of the animals and the environmental conditions from which they are harvested. In addition, conditions and handling at harvest and processing, as well as during distribution and preparation, may enhance or reduce the risk of seafood-borne disease. The Approach to Seafood Safety Unlike meat and poultry, the inspection system for seafood safety is under the jurisdiction of FDA. This system also differs from that in the meat and poultry industry in that regulatory inspections are not performed on a continuous, on-site basis.

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264 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD Anticipating that the seafood industry would need assistance in HACCP plan development and implementation, FDA issued the Fish and Fisheries Products Hazards and Control Guide, commonly referred to as "the Guide." The com- mittee recognizes that the Guide is an innovative and useful document that effec- tively assists seafood processors with the development of their HACCP plans. To improve the utility of the Fish and Fisheries Products Hazards and Control Guide, the committee recommends that FDA consider the following measures: Introduce a more collaborative process in further developing the Guide. To this effect, the committee recommends that FDA appoint a Hazards and Control Guide Advisory Committee. Further address the issues of expert capability and process. Develop a protocol to guide process validation. This protocol must address criteria for distinguishing the creditability of processing authorities, sampling plans, experimental designs, and appropriate methodologies. Validation and verification guidelines, including rec- ommendations for adequate analytical methods and sampling plans, should also accompany the recommended controls in the Guide. Develop a protocol to recognize the application of analytical method- ologies, such as new, rapid test procedures that can be utilized in process validation and in routine verification. Enhance communications to ensure awareness, understanding, and consistent application of the Guide. In addition, the committee believes that screening limited quantities of seafood products at points of entry is not consistent with the preventive concept of HACCP; hence, prevention of seafood safety hazards in imported seafood must place greater emphasis on intervention prior to shipment. The committee recommends that FDA give immediate attention to the application of the Guide to ensure food safety equivalence in international seafood commerce. The committee believes that the intent of the Guide and its contents need to be clarified to U.S. trading partners. Aware that international collaboration is essential to enhance seafood safety, the committee recommends that FDA initiate an International Seafood Safety Exchange Program to foster international collaboration in seafood safety research and training. A common topic for initial consideration could be the development of Best Aquaculture Practices. The existing FDA Guide, as well as relevant documents already published by other organizations, could be used as models.

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OVERALL FINDINGS AND RECOMMENDATIONS Criteria for Control of Chemical Contaminants and Toxins in Seafood 265 The committee examined current safety criteria applicable to seafood includ- ing tolerances, action levels, and guidelines, and concluded that the specific scientific basis for each of them differs, depending mainly on the availability of data about a hazard. The tolerance for methyl mercury content in fish (1.0 ppm) for example, is appropriately based on the level necessary for consumer safety, whereas the labeling requirement for sulfite residues (10 ppm) is also appropri- ately based on the lower limit of analytical capability. All seafood safety criteria established prior to the seafood HACCP rule remain in place within the current regulatory system. Therefore, processors must produce seafood that comply with all relevant food safety criteria. The committee recognizes that, in most cases, these criteria cannot be used as critical limits for CCPs in HACCP plans, but can be used as verification criteria when end-product testing is warranted. Thus, direct monitoring of chemical contaminants using analytical tests would often be impractical as a CCP because of the significant variability in concentration for some of these contaminants among geographic areas. However, this geographical variability makes it possible to reduce con- sumer exposure to such contaminants through restrictions of harvesting sites. Therefore, the committee concludes that harvest location restrictions are meaningful and effective controls for chemical contaminants in seafood. The committee also recognizes that chemical hazards that are not of environ- mental origin, such as scombrotoxin, require a different control strategy. Because monitoring of histamine levels in each fish received at a processing plant would not be viable, the committee concludes that an alternate procedure based on review of the harvest records, both time and temperature, associated with each lot of fish is an acceptable procedure for monitoring histamine levels in seafood within a HACCP system. Criteria for Control of Vibrio vulnificus and V. parahaemolyticus in Raw Oysters As with chemical contaminants, control of pathogenic microorganisms in shellfish is based on restrictions of harvesting sites. The fecal coliform standard for shellfish harvesting waters, in turn, is based on the potential presence of microbial pathogens. The important role that innovation may play in enhancing seafood safety in the future is illustrated by the strategy adopted for control of V. vulnificus and the related species, V. parahaemolyticus, in raw oysters. The committee concludes that the mandate for postharvest treatment in the model ordinance to reduce illnesses from consumption of raw oysters is a unique and novel approach to enhancing seafood safety.

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266 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD Safety Criteria for Produce and Related Products Fruits and vegetables provide many health benefits and are an important component of the American diet. Consumption of these products in the United States has increased considerably in the past two decades, with corresponding increases in the volume of imports. Producers have responded to this increased demand not only by growing new varieties of fruits and vegetables, but they have also introduced novelty produce items in the marketplace and developed a large niche for fresh-cut produce. Although fresh produce and juices were not traditionally thought to be im- portant vehicles of foodborne disease, this notion has changed in recent years. Fresh produce safety is of special concern to the public health community because fruits and vegetables often do not receive any treatment specifically designed to kill all microbial pathogens prior to consumption. The Approach to Produce Safety There are virtually no criteria or standards for microbiological safety cur- rently being applied to fresh produce or fresh-cut produce in the United States other than those pertaining to sprouts and fruit juices. The committee recognizes that to minimize foodborne disease from being transmitted through fresh produce, it is necessary to prevent initial contamination of these products and to control the potential amplification of pathogens in them throughout the production and dis- tribution chain. Intervention strategies currently being applied in the fresh produce industry are Good Agricultural Practices in the field and packing houses and GMPs in fresh-cut operations. The committee recognizes that the principles that make up the current Good Agricultural Practices recommendations are necessarily general given the broad range of fruits and vegetables and their growing conditions, and, like GMPs, they focus on minimizing the potential for microbial contamination. The committee also recognizes that data gaps on risks associated with many specific practices in the fresh produce sector make it diffi- cult to assess which intervention strategies could provide the greatest reduction in risk. Among these, the committee discussed the issue of potential internalization of pathogenic bacteria during growth or processing of produce and concluded that research is urgently needed in this area. . The committee recommends that FDA conduct or support additional studies to determine whether the internalization of bacteria repre- sents a significant safety hazard in fruits and vegetables. There have been few attempts to integrate the various steps associated with production and processing of fresh produce into a farm-to-table HACCP system. Several HACCP plans have been developed for sprouted seeds, shredded lettuce,

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OVERALL FINDINGS AND RECOMMENDATIONS 267 and tomatoes, but complete validation of these plans has not yet been accom- plished. The committee concludes that currently available data are insuff;- cient to develop validated HACCP plans for most fresh produce items. Also, prerequisite programs, such as Good Agricultural Practices and GMPs, which provide the foundation for HACCP systems, are still being defined and evaluated for their effectiveness on farms and in orchards. It is expected that data from ongoing research in this area will provide valuable information to supplement the basic guidelines. In view of the trend toward greater importation of fruits and vegetables into the United States, the committee expressed concern about harmonization of food safety standards for imported produce. Several international efforts in this direc- tion are underway, and some efforts are being made by FDA to survey pathogen contamination in imported produce. Domestic surveys are also being conducted by FDA and USDA to establish a microbiological baseline to assess the risk of contamination in the domestic supply; however such efforts need integration. The committee reiterates that there is a need to develop a framework that allows timely sharing of data from surveillance programs on microbial contamination in specific high-risk fresh and fresh-cut produce and related products and from human, animal, and environ- mental isolates, and eventual integration of such data. The committee further points to the need for a structured review process for guidance documents and regulations, with input from a wide variety of experts from industry, government, and academia, using the National Advisory Committee on Microbiological Criteria for Foods model. This review process should be used to modify or rescind criteria as science evolves. Pathogen Reduction Criteria in Fruit and Vegetable Juices As a consequence of foodborne disease outbreaks associated with raw juices processed at commercial facilities, FDA introduced regulations for all juices produced for inter- or intrastate sale. This regulation mandates that juice be produced under a HACCP plan having supporting GMPs and Sanitation Standard Operating Procedures. In addition, it requires that juice processors achieve at least a 5-log reduction (referred to as a 5-D process) in numbers of the pertinent microorganism, defined as "the most resistant microorganism of public health significance that is likely to occur in the juice." Although thermal treatments are most commonly used to ensure the required 5-D reduction, other processes will be accepted if appropriately validated. FDA issued a Juice Hazards and Control Guidance Document that provides some background on validating these alternate treatments, which was complemented with an educational program developed by the Juice HACCP Alliance.

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268 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD Processors of raw citrus juices are allowed to use surface decontamination methods to achieve part of the 5-D pathogen reduction requirement under circum- stances specified in the rule. The publication by FDA of information explain- ing the scientific justification of the sampling plans for citrus juices that rely on surface treatments to achieve a 5-D pathogen reduction is an excellent example of using data and expert opinion to develop criteria or standards; the committee believes that this derivation could be used as a model when regulatory agencies develop other criteria or standards. In contrast, the justi- fication for a 5-D pathogen reduction process for citrus juices is described in a memorandum, with no reference to the scientific data from which the standard derives. As mentioned earlier, transparency of the criteria development process requires that the data and the assumptions made be clearly communicated. The committee concludes that it would be premature to try to evaluate the public health impact of the new juice regulations. However, the fact that no disease outbreaks attributable to Salmonella or E. cold 0157:H7 in juices have been reported to the Centers for Disease Control and Prevention since the juice regulation was implemented is noteworthy. Control of Patulin in Fruit Juices The committee concludes that the action level established by FDA for patulin in apple juice, apple juice concentrates, and apple juice products, 50 ,ug/kg (50 ppm), is appropriate. This level can readily be achieved with proper adher- ence to GMPs. Criteria for Low-Acid and Acidified Canned Foods For low-acid canned foods, a 12-D pathogen reduction thermal process must be applied. This regulation includes other foods besides vegetables. For acidified low-acid foods, defined as having a pH of 4.6 or below after equilibration, the key control parameter is the acidification step rather than the thermal process. Acidification of the food must be adequate so that the pH will not permit the growth of microorganisms of public health significance. Other requirements for these foods include standardized training of retort operators, registration of the canning facility at state and federal levels, filing of thermal processes, record keeping, and establishment of a recall program. The committee recognizes that a clear example of the success of a per- formance standard is illustrated by the fact that after the establishment of the low-acid and acidified canned food rules and GMP regulations in the 1970s, only occasional cases of botulism attributable to these foods have occurred. The committee also believes that the 12-D performance standard for low-acid canned food might be too stringent and thus might compromise some quality attributes of certain canned foods; therefore, it should be

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OVERALL FINDINGS AND RECOMMENDATIONS 269 reevaluated. The committee is aware that technological innovation based on nonthermal food-processing technologies is critical to the development of new fruit and vegetable products. However, the committee reiterates its recommen- dation that, prior to developing performance standards that accommodate process or other technical innovations, guidance must be provided to indus- try on process validation. Criteria for Sprouts As a result of several disease outbreaks associated with the consumption of sprouts, FDA published the document Guidance to Industry Reducing Micro- bial Food Safety Hazards for Sprouted Seeds, which recommends specific mea- sures that sprout producers should apply to minimize pathogen contamination and growth during sprout production. The committee recognizes that proper application of this guidance enhances the safety of sprouts, but that it would be premature to assess the effectiveness of the guidance. Nevertheless, the committee notes that all sprout outbreaks reported since the publication of the FDA guidelines have been associated with seed that was sanitized using methods other than those described in the guideline. Pesticide Residues The committee believes that the process used to establish pesticide toler- ances in produce is a good approach to ensure public health. The process of setting pesticide tolerances by the U.S. Environmental Protection Agency is in agreement with the committee's belief that food safety standards should be developed based on a combination of the best available science and expert opinion, and that this process should be a transparent one. Safety Criteria for Dairy Products Anecdotal observations that linked consumption of milk with the spread of disease spurred various scientists and physicians in the United States and around the world to undertake research to investigate the role of milk consumption in foodborne disease as early as the turn of the twentieth century. Consumption of unpasteurized milk was found to be associated with many serious diseases, includ- ing diphtheria, typhoid, tuberculosis, and brucellosis. Early reports provided evidence suggesting that control of milk-borne diseases required application of sanitation measures at all points in the food system, from the farm to the con- sumer. These observations also highlighted the need for technical research to determine the bacterial destruction characteristics of food-processing treatments for pathogenic microbes likely to be present in raw milk. The results of these studies led to pasteurization and other intervention strategies designed to protect

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270 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD the public from exposure to hazardous microorganisms that may be present in raw milk. The Approach to Milk and Other Dairy Products Safety Criteria for the safety of milk and other dairy products are defined in the "Grade A Pasteurized Milk Ordinance," commonly referred to as the PMO. The PMO is considered the reference for federal specifications for the procurement of milk and dairy products and as the sanitary regulation for dairy products served by carriers during interstate travel. It is also recognized by public health agencies and the dairy industry as the national standard for milk sanitation. This ordinance is administered by the National Conference on Interstate Milk Shipments and the Cooperative State Public Health Service Program for certification of interstate milk shippers, with FDA having oversight responsibility. Currently, all states, the District of Columbia, and the United States trust territories participate in the National Conference. The committee recognizes that development, implementation, and enforcement of the PMO has been directly credited with reducing the inci- dence of milk-borne disease, and that the PMO is a good model for an integrated strategy for product safety assurance. In addition, this model also provides a specific structure and mechanism for biennial review of existing regulations directed toward the fluid milk industry. Nevertheless, the com- mittee notes that milk for local consumption is not subject to FDA oversight. Therefore, consumption of unpasteurized (raw) milk continues to be an issue of concern. The committee concludes that targeted educational programs that illus- trate the hazards of raw milk and raw milk-product consumption for milk producers and for the general public are warranted. Through evolution of the PMO and other dairy standards, the dairy industry has a long history of application of regulations to ensure the safety of its products intended for interstate commerce. Nevertheless, the National Conference has proposed its own testing of HACCP as an alternative to the traditional dairy inspection/rating/check system. The committee concludes that one of the greatest challenges facing the dairy industry is the incorporation of HACCP into the regulatory format already in place, and commends the dairy industry for volun- tarily implementing a HACCP pilot program. In addition, the committee strongly encourages the timely adoption of HACCP systems throughout various sectors of the dairy processing industry. Adoption of performance standards for pathogen reduction, such as that proposed for cheese manufacturing, would more appropri- ately fit into a HACCP framework than in the dairy industry' s current regulatory system.

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OVERALL FINDINGS AND RECOMMENDATIONS Criteria for Control of Hazards in Milk and Milk Products 271 In addition to specific recommendations for pasteurization conditions speci- fied in the PMO, chemical, bacteriological, and temperature standards have been established for grade A raw milk products intended for pasteurization, as well as for grade A pasteurized and bulk-shipped, heat-treated milk products. Concern- ing the strict process requirements for milk pasteurization, the committee reiter- ates its belief that implementation of performance standards that specify the reduction in numbers required for a targeted organism in a food product, rather than specifying the precise conditions for achieving that end (as currently practiced), could allow greater flexibility and innovation in the dairy industry, perhaps enabling the adoption of effective new processing technologies. Despite the success of pasteurization in ensuring milk safety, the committee notes that, in addition to incomplete destruction of spore-forming bacteria, the efficacy of pasteurization in destroying other highly heat-resistant microbes that may be present in raw milk, such as Mycobacterium avium subspp. Paratuberculosis, requires FDA attention. Recent illness outbreaks linked to dairy foods that had been successfully pasteurized, but then subjected to postpasteurization contamination with bacteria such as Listeria monocytogenes or Salmonella, highlight the critical need for application of effective processing- plant sanitation programs to prevent postprocessing contamination of these products. Somatic cell count limits for raw milk intended for pasteurized products are arguably a safety standard, as exceeding these limits may prevent effective appli- cation of a pasteurizing process. Similarly, the microbial standards for pasteur- ized fluid milk products total bacteria and coliform bacteria are considered a reflection of good management. The committee notes that despite the clear link that has been established between raw milk consumption and foodborne illnesses, some consumers continue to drink raw milk. . To further decrease the association between dairy products and food- borne illnesses, the committee recommends that FDA and public health agencies target educational programs to communicate to consumers that drinking raw milk represents a form of risky food- consumption behavior. In addition, state and local health authorities should ban the sale of unpasteurized milk. Criteria for Control of Hazards in Cheese Current regulations state that no milk or milk products in final package form intended for direct human consumption shall enter interstate commerce unless they are manufactured from pasteurized milk or pasteurized milk ingredients, except where alternative procedures are provided for by regulation. Moreover,

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272 SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD standards of identity have been established for most natural cheeses, process cheeses, cheese foods, and cheese spreads. The committee examined the requirement that cheese made from unpasteur- ized milk be cured for a period of 60 days at a temperature not less than 35F, and concludes that the scientific basis for this requirement is unclear. . The committee recommends the development and implementation of a scientifically appropriate performance standard for the reduction of targeted pathogens in finished cheese products that result from the processing strategies or aging periods employed in the manufacture of the products. The cheese industry and FDA should work together to conduct or sponsor research to assess pathogen reduction efficacies of cheese manufacturing condi- tions. The use of pasteurized milk in cheese manufacturing may provide an appro- priate safe harbor for the manufacture of products for which adequate pathogen reduction may not occur during manufacture or a holding period without an additional intervention. In the meantime, to enable consumers to make informed decisions regarding consumption of unpasteurized milk products, the com- mittee recommends that FDA and state authorities require cheeses manufactured from subpasteurized milk to be clearly and promi- nently labeled as such at the point of purchase.