4.5 Prevention
Risk In Perspective--Very conservative risk assumptions, which are intended to err on the side of health protection, may frequently result in substantial overestimates of risk. There is a need for improved methods of estimating potential foodborne disease in order to prevent and reduce foodborne illness, while ensuring a strong and viable food industry.
Risk is often put into perspective using numerical estimates, such as "a one in one million chance" of an accident occurring. How are these numbers derived? Many statistics, such as the average person’s risk of dying from accidents and violence, are based on hard actuarial data. In contrast, the human cancer risks resulting from low-level chemical exposure in air, food, and water are rarely based on direct observation of human populations. These figures are typically based on high-dose animal studies, which are then extrapolated to determine risks to humans from exposure to low doses.
Within the field of environmental health, some risks are far less speculative than others. The risks of childhood lead poisoning, indoor air pollution, and occupational exposures to chemicals are relatively well understood by citizens and policy makers. Some of the non-cancer health effects from pollution, ranging from aggravation of asthma to neurobehavioral effects, have a stronger technical foundation than is commonly realized. In contrast, many of the traditionally popular and expensive environmental protection programs have a weak foundation in risk analysis.
The Science of Risk Assessment--NASDA supports the development of uniform food safety regulations and policies that also permit a certain degree of state flexibility to promulgate regulations that address circumstances that may be unique to that state.
No subject is a greater source of misinformation and public confusion than the assessment of relative risk to human health, safety, and the environment. The mathematics of probability is not easy to understand. It is difficult to distinguish the relative difference in the degree of risk between a probability of one in 10,000 and a probability of one in 1,000,000. The issue is further complicated when seemingly qualified scientists dispute the underlying data and assumptions upon which risk calculations rest. Even when the science of risk assessment is crystal clear, there are still value judgments to be made about which risks deserve the highest priority and how safe is safe enough.
Generally, when public health issues are ranked by experts, microbial threats are a greater problem than chemical hazards. However, both chemical and biological hazards present separate potential public health problems that must be addressed in the nation’s food safety policy. While microbial threats are often manifested in immediate, acute reactions ranging from gastrointestinal upset to death, chemical threats may take a lifetime to manifest themselves as disease or genetic changes that affect the next generation. Both problems demand a diligent and effective response from state and federal governments.
No magic risk number can substitute for informed and thoughtful consideration by accountable officials who work with the public to make balanced decisions. Public officials play a key role in determining which involuntary threats to human health are unacceptable and which are acceptable based upon the best available science and not just perception.
In general these regulations and policies should be applied in a consistent manner across federal, state and local agencies. However a necessary first step in the introduction of uniform nationwide food safety policy and the prioritizing of resource allocation is the need to develop sound scientific information on which to base that policy.
A national risk assessment model must be developed at the federal level for use in conducting risk assessments of commercial food handling operations from farm to retail. The model should be suitable for use in assessing the risks associated with both accidental and intentional contamination of our food supply and should take into account both food safety and food defense. Standardized risk management procedures based on risk assessment results should be used to weigh policy alternatives and to develop and implement the appropriate regulatory response. An active risk communication network should be established to facilitate the exchange of information among those in industry and government who are assessing risk or developing methods to mitigate or manage risk.
A voluntary Model Food Defense Code should be developed to ensure that states have the tools necessary to close gaps identified through risk assessments. The development of standardized food safety protocols embodied in the Model Food Code have enabled jurisdictions at all levels to establish a uniform system of regulation to ensure that food is safe for consumers. The very real threat of an attack on the food supply demands that additional measures be taken to ensure that food offered for sale has been handled under the most secure conditions from farm to table.
Decisions Based on Sound Science--No magic risk number can substitute for informed and thoughtful consideration by accountable officials who work with the public to make balanced decisions. Public officials play a key role in determining which involuntary threats to human health are unacceptable and which are acceptable based upon the best available science and not just perception.
Risk Analyis In Food Safety Regulation--A national risk assessment model must be developed at the federal level for use in conducting risk assessments of commercial food handling operations from farm to retail. A voluntary Model Food Defense Code should be developed to ensure that states have the tools necessary to close gaps identified through risk assessments. NASDA supports the development of uniform food safety regulations and policies that also permit a certain degree of state flexibility to promulgate regulations that address circumstances that may be unique to that state. In general these regulations and policies should be applied in a consistent manner across federal, state and local agencies. However a necessary first step in the introduction of uniform nationwide food safety policy and the prioritizing of resource allocation is the need to develop sound scientific information on which to base that policy.
The model should be suitable for use in assessing the risks associated with both accidental and intentional contamination of our food supply and should take into account both food safety and food defense. Standardized risk management procedures based on risk assessment results should be used to weigh policy alternatives and to develop and implement the appropriate regulatory response. An active risk communication network should be established to facilitate the exchange of information among those in industry and government who are assessing risk or developing methods to mitigate or manage risk.
The development of standardized food safety protocols embodied in the Model Food Code have enabled jurisdictions at all levels to establish a uniform system of regulation to ensure that food is safe for consumers. The very real threat of an attack on the food supply demands that additional measures be taken to ensure that food offered for sale has been handled under the most secure conditions from farm to table.
Microbiological testing, as necessary to verify the effectiveness of an establishment’s procedures for controlling microbiological hazards, should be an integral part of the risk-based system. This testing should be done to determine if the process is effective and not attempt to establish microbiological standards. The frequency of testing required should be proportional to production volume and frequency of detection, and not based on a calendar schedule.
A significant difference exists between microbiological testing in raw and ready-to-eat foods. Science and technology indicate that it is currently impossible to ensure that raw meats and poultry are free of potential pathogens. As a result, microbiological testing of raw meat and poultry for other than informational purposes and verification of HACCP systems is inappropriate. Microbiological testing in ready-to-eat foods is appropriate and should continue to be mandatory.
HACCP and HACCP Plans--In order to provide efficient utilization of current resources, risk assessments must be made in all segments of meat, poultry, exotic, and aquatic food production, and resources should be allocated in areas where significant risks to consumers can be reduced.
The production of wholesome food for consumers is a cooperative effort between the food industry and governmental agencies. In order to be successful, a sincere spirit of cooperation between the food industry and the government is essential. The incorporation of HACCP plans into the industry must change the way the Secretary of Agriculture allocates resources for inspection.
While HACCP has primarily been required in the meat, poultry, exotic animal, and aquatic industries, HACCP’s application is much broader than just food inspections. HACCP has proved effective in canned food processing, and HACCP or HACCP-compatible systems should be applied to all food production and processing. General guidelines to assist producers, processors, and distributors in HACCP plan development should be available. Testing should be used as a tool to verify the effectiveness of HACCP plans.
HACCP programs can result in enormous safeguarding benefits for the food system, however, it requires a resource commitment on the part of industry. Government agencies should support the movement towards HACCP systems in the food industry. Support could be in the areas of training, research, model plans, and other tools to assist the industry in HACCP implementation.
These HACCP plans must be unique for each operation. Critical control points should be identified, critical limits established, and corrective action procedures developed for processes that are outside of acceptable limits. These plans must be reviewed and updated on a regular basis. Flexibility is necessary in preparation and implementation of these plans. The Secretary of Agriculture and state meat and poultry inspection agencies should monitor the overall effectiveness of these industry plans. A sincere sense of cooperation and collaboration between the industry and the government is essential for a successful risk-based inspection system.
While NASDA supports the use of HACCP programs along the complete "farm to fork" continuum, we recognize that there are major gaps in knowledge and information, making it effectively impossible to implement in some areas. In particular, we know little about effective intervention at the farm production level.
Modernization of the nation’s meat, poultry, and seafood inspection system must be based on the principal idea of reducing the risks of foodborne disease to consumers. Inspection programs should provide oversight that focuses on prevention of food safety hazards. Risk-based inspection will lead to overall safer products by focusing scarce inspection resources in areas with a greater risk potential. Government resources can then more efficiently be directed at ensuring that the hazard control procedures achieve the program’s objective through monitoring and verification of the industry’s activities.
The main value of a Hazard Analysis and Critical Control Point (HACCP) system is prevention rather than detection. The HACCP system involves determining points along the food production chain where contaminantion can occur. Safeguards are then developed for these critical control points to prevent food safety hazards. Records are kept to help trace problems to their origin. Verification systems are established to ensure that the program is effective.
Therefore it is unwise to mandate HACCP programs. However, with sufficient research we believe it possible to identify strategies that will significantly reduce the incidence of on-farm foodborne contamination. Furthermore, it is critical to have an effective transfer of technology and information to the farm. Coordination of research efforts is necessary between state and federal agencies. Enhanced disease reporting procedures would allow agencies to identify research needs at an early stage.
Expanded Use of HACCP—NASDA believes government agencies must focus regulatory efforts on preventing or minimizing food safety risks (i.e., verifying the efficacy and application industry designed and operated food safety systems).
Food safety management regulations based upon the Hazard Analysis Critical Control Point [HACCP] principle currently exist at the federal level for meat & poultry products, fruit juices, and fishery products. HACCP is recognized as a systematic and prevention oriented control mechanism for dealing with food safety hazards. It should be employed for all food processing types.
Research--While NASDA supports the use of HACCP programs along the complete "farm to fork" continuum, we recognize that there are major gaps in knowledge and information, making it effectively impossible to implement in some areas. In particular, we know little about effective intervention at the farm production level; therefore it is unwise to mandate HACCP programs. However, with sufficient research we believe it possible to identify strategies that will significantly reduce the incidence of on-farm foodborne contamination. Furthermore, it is critical to have an effective transfer of technology and information to the farm. Coordination of research efforts is necessary between state and federal agencies. Enhanced disease reporting procedures would allow agencies to identify research needs at an early stage.
Preharvest Food Safety--NASDA supports development of uniform, but voluntary standards for pre-harvest food safety, with input from all parties and a clear articulation of the risks and benefits associated with adoption of those standards. Basic and applied research is needed to define specific interventions that will positively impact food safety, and which can be used in the development of uniform standards. Moreover, pre-harvest food safety efforts should also be integrated with overlapping issues such as nutrient and waste management, environmental protection, rural economic development, and animal health and welfare.
NASDA encourages continued work on the Federal/State National Auditing Alliance to verify good agricultural practices and good handling practices. NASDA also supports the concept, similar to the approach used for environmental protection efforts, to provide federal support and incentives to producers who voluntarily establish verifiable pre-harvest food safety programs. NASDA proposes a Food Safety Quality Assurance block grant program, administered by the states, to facilitate the adoption of innovative food safety assurance programs on farm. In addition, there is a need for uniform education regarding the national program to Retailers and International Market Buyers of the USDA Federal State Program. NASDA requests that USDA AMS Fresh Products Branch begin an educational campaign to inform retail buyers of the program and the advantage of the uniformity provided by the Federal State Auditing Program.
Pre-harvest food safety relies on activities conducted by livestock and crop producers which prevent or reduce the occurrence of organisms, agents or conditions that pose an animal health or food safety risk. Most current regulatory programs, however, are focused on post-harvest food safety practices (transportation, processing, retail sale). NASDA believes measures can be taken at the farm level to minimize or reduce the potential for foodborne illness further down the processing chain. We believe this because such measures are successfully being taken in many cases.
Many food retailers and distributors are now calling for third-party food safety inspections of their producer suppliers. In these instances, producers engage the services of a third party to verify that plant and animal production is occurring in accordance with a set of standards. The on-farm standards used vary among states, third-party verifiers, buyers, as well as by crop or animal produced. Consistent standards are needed to ensure that food producers can ensure food safety, satisfy consumer concerns, address the emergence of new organisms and satisfy current and potential export markets. On-farm quality assurance standards should be voluntary, well conceived, sustainable over time, flexible, transparent, uniform and include an evaluation mechanism. Many states are already moving forward to design and implement effective producer-oriented quality assurance programs. For example, the California Department of Food & Agriculture is participating in several on-farm quality assurance programs. The structure of the programs and degree of involvement varies by commodity and their unique needs. More basic and applied research, as well as educational efforts, is also needed.
Incentives, technical assistance, and a comprehensive approach can be used to increase the speed and the extent that standards are adopted on farms. Because of the nature of food handling activities on farms, a comprehensive, integrated approach is needed for ensuring that standards are utilized. Verification that food safety standards are being utilized effectively can be accomplished in a number of ways including third party, HACCP, an overarching audit, or by epidemiological indicators.
Harvest--NASDA supports requiring those facilities involved in animal harvest to develop and implement written HACCP plans, which identify and control public health hazards for products of animal origin during harvest. The plans should encompass ante-mortem and post-mortem procedures in addition to other identified critical control points (i.e. dressing procedures, sanitation, facility requirements, etc.).
Harvest activities include the conversion process from a live animal to a carcass, the removal of plant material from its growing media, and the harvesting, picking, or collecting of a raw agricultural product or seafood. Once a facility’s plan has been satisfactorily implemented, the Secretary of Agriculture should focus efforts on verifying the effectiveness of the facility’s plan and the facility’s compliance with it. The intensity of government oversight should depend upon many factors including the risks presented by particular products and slaughter operations, the effectiveness of a facility’s plan, and each facility’s compliance with the plan. In facilities that slaughter a uniform, high quality animal, produced under an effective, well documented quality assurance program, the Secretary should not be required to provide 100 percent evaluation of the animals for disease or aesthetic defects (organoleptic inspection). The facility should assume this responsibility as a part of its HACCP plan. A HACCP system developed and implemented by the establishment which could include government verification and minimal inspection oversight would be superior to continuous organoleptic inspection used alone. Facilities harvesting animals that are not uniform and/or of high quality or originate from farms that do not have an effective quality assurance program should still be subject to 100 percent evaluation of animals by the Secretary for disease or aesthetic defects. Facilities involved in plant material harvest should follow HACCP-compatible good agricultural and sanitation practices.
Processing--The most significant reduction in risk of foodborne disease can be made by controlling the processes that occur during post harvest production. Processing includes the wholesale and retail handling and modification of plant and food products after the harvest phase and prior to consumption. Wholesale processing includes meat and poultry processing, egg product processing, and further processing of other food products for wholesale and distribution in commerce. It also includes cooking, baking, heating, drying, mixing, churning, separating, extracting, cutting, freezing, or otherwise manufacturing a food or changing the physical characteristics of a food, and the packaging, canning or otherwise enclosing such food in a container, but does not mean the sorting, cleaning, or water-rinsing of a food. Retail processing includes the handling of foods at restaurants, retail stores, vending operations, and other institutions. The steps that are taken at these facilities pose risks to consumers.
Wholesale Processing--Mandatory HACCP plans should be required for all post harvest wholesale processing operations. Each wholesale food processing facility should develop a HACCP plan to control, monitor, and verify the critical processes that are conducted in that operation. Plant operators and plant employees should be responsible for implementing these plans and taking control of the food production processes in their operations. The Secretary of Agriculture and states should monitor and verify the implementation of those plans.
It is important to note that not all establishments must have a HACCP plan. NASDA believes all processors should conduct a "hazard analysis" of their operation. Where significant hazards are identified, then a HACCP plan is required. Many establishments will not have significant hazards and would not need a HACCP plan.
Manufactured Food Regulatory Program Standards (MFRPS)--MFRPS is currently being piloted in five states, such as North Carolina. The goal of MFPRS is to establish equivalency among the state regulatory programs by identifying key elements of a high quality regulatory program such as laboratory, resources, inspection program, outreach, training, etc. NASDA encourages states to participate in MFPRS and urges FDA to provide additional funding for states to fulfill the requirements of the standards.