Effective Management Strategies Contamination Prevention And Intervention

Every foodborne illness outbreak is a tragic event, and an approach that prevents contamination and possible amplification of human pathogens in the produce supply chain is the most effective means of ensuring fresh produce safety. However, the complexity of effectively implementing this strategy is stated concisely by the FDA [16]:

Although the available scientific literature is adequate to identify sources of contamination and estimate microbial persistence on plants, the specific influence and interactions among the production environments and crop management practices are not sufficiently understood to provide detailed guidance to growers and shippers. Also, the diversity of cropping systems, scale of operation, use and design of equipment, regional and local practices, environmental influences, specifics of on-farm soil related factors, and many other production factors defy any attempt to develop an encompassing assignment of microbial risk to commodities or to crop management practices.

Sampling produce is not an effective means of ensuring product safety. Data from the USDA MDP and FDA domestic and imported produce sampling surveys indicate that human pathogens are found on fresh produce infrequently and in low numbers. Because of this fact increased sampling for the presence of human pathogens by either private enterprises or government regulators will not effectively reduce foodborne illnesses associated with produce consumption because it is simply an ineffective strategy. Increased produce sampling or surveillance would also potentially take valuable limited resources away from potentially more productive research efforts that identify risk factors and mitigation strategies.

Approaches that prevent contamination are warranted and these strategies include effective management and intervention strategies for growing, handling, distributing, and preparing fresh produce that include but are not limited to:

• Good Agricultural Practices (GAPs)

• Good Manufacturing Practices (GMPs)

• Hazard Analysis Critical Control Point (HACCP) programs

1.6.1 Good Agricultural Practices (GAPs)

The FDA published Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables in 1998 which has since come to be referred to as Good Agricultural Practices (GAPs). Although this document carries no regulatory or legal weight, due diligence requires producers to take prudent steps to prevent contamination of their crops. GAPs have been widely implemented by the fresh fruit and vegetable industry and as formulated provide the produce industry with an excellent description of broad prescriptive actions that may be taken to enhance produce food safety. Numerous retail and wholesale buyers have made compliance to GAPs, and subsequent independent third-party audits to ensure compliance with GAPs, a requirement for the purchase of fresh fruits and vegetables.

The guide identifies eight principles of food safety within the realms of growing, harvesting, and transporting fresh produce and suggests that the reader "use the general recommendations in this guide to develop the most appropriate good agricultural and management practices for your operation.'' The application of these principles is aimed at preventing contamination of fresh produce with human pathogens. The eight principles are listed below followed by areas of implementation:

1. Prevention of microbial contamination of fresh produce is favored over reliance on corrective actions once contamination has occurred.

2. To minimize microbial food safety hazards in fresh produce, growers or packers should use GAPs in those areas over which they have a degree of control while not increasing other risks to the food supply or the environment.

3. Anything that comes in contact with fresh produce has the potential of contaminating it. For most foodborne pathogens associated with produce, the major source of contamination is associated with human or animal feces.

4. Whenever water comes in contact with fresh produce, its source and quality dictate the potential for contamination.

5. Practices using manure or municipal biosolid wastes should be closely managed to minimize the potential for microbial contamination of fresh produce.

6. Worker hygiene and sanitation practices during production, harvesting, sorting, packing, and transport play a critical role in minimizing the potential for microbial contamination of fresh produce.

7. Follow all applicable local, state, and federal laws and regulations, or corresponding or similar laws, regulations, or standards for operators outside the U.S. for agricultural practices.

8. Accountability at all levels of the agricultural environment (farms, packing facility, distribution center, and transport operation) is important to a successful food safety program. There must be qualified personnel and effective monitoring to ensure that all elements of the program function correctly and to help track produce back through the distribution channels to the producer.

It is currently unclear if recent outbreaks associated with consumption of produce are due to lack of compliance with GAPs or if there are deficiencies in GAPs as they are currently formulated. Little scientifically based data exist regarding the risk associated with many of the production and post-harvest handling practices commonly used in production agriculture and in postharvest handling situations or what the most effective risk management strategies may be.

1.6.2 Current Good Manufacturing Practices (cGMPs)

The cGMPs are set forth in 21CFR110 and provide guidelines that ensure that food for human consumption is safe and has been prepared, packed, and held under sanitary conditions. The cGMPs provide food processors, such as fresh-cut produce processors, with the core principles of sanitary food handling, and they serve as well-recognized and agreed upon standards of conduct and operation. The cGMPs are well written in that they provide general guidance regarding regulatory expectations of performance and conduct without being overly specific or prescriptive, and this aspect of the cGMPs accommodates the many diverse specific situations that are encountered in the food industry today. The regulations as currently written provide flexibility for the diverse formats under which these regulations are applied, by use of terminology such as "adequate facilities,'' ''where appropriate," "necessary precautions," and "adequate controls.'' This flexibility allows the cGMPs to be applied to the plethora of situations encountered during the production, handling, and distribution of food products. Also, and very importantly, by not being overly prescriptive the cGMPs allow for incorporation of new technologies and innovation without the need to revise the regulations. The cGMPs are the commonly agreed upon and scientifically based standards by which industry and regulators effectively and harmoniously communicate the standards of performance and conduct when food products are being prepared, packed, or held. As such the cGMPs are centrally important in reducing the risk of product adulteration and food safety risk to consumers.

21CFR110.19 specifically exempts raw agricultural commodities from compliance with cGMPs, and raw agricultural commodity safe production and postharvest handling practices are not as clearly defined and commonly agreed upon as cGMPs and HACCP in the food processing industry. Therefore, raw agricultural commodities producers and handlers do not have the advantage of simply adopting long-standing food safety programs that exist in the food processing industry, as they must modify these programs on a site-specific basis.

1.6.3 Hazard Analysis Critical Control Point (HACCP)

Hazard Analysis Critical Control Point (HACCP) is a systems approach method to ensure the safety of a food product. The terms HACCP and food safety program are often used interchangeably and synonymously. However, HACCP is not the equivalent of a food safety program, as HACCP is merely a component of an overall food safety program. The terms food safety program and HACCP are not interchangeable and should not be used synonymously. A HACCP plan cannot be established without prerequisite programs such as GAPs, cGMPs, and sanitation standard operating procedures (SSOPs) being in place. HACCP is a food safety system pioneered by the Pillsbury Co. to reduce the risk associated with the food eaten by astronauts for manned space flights. HACCP is a systems approach that:

• Identifies potential sources of contamination in food production systems.

• Establishes methods for detecting the occurrence or prevention of contamination.

• Clearly prescribes what corrective actions will be taken to prevent consumption of contaminated food items.

The National Advisory Committee on the Microbiological Criteria for Foods (NACMCF) has clearly defined what HACCP is in a 1997 document entitled HACCP Principles and Application Guidelines (available on line at: www.fst.vt.edu/haccp97/). In this document, NACMCF clearly defines seven criteria that must be met by a HACCP program [67]. The seven basic principles of HACCP are:

1. Assessment of hazards.

2. Determine critical control points (CCPs) to control the identified hazards.

3. Establishment of limits at each CCP.

4. Establishment of CCP monitoring procedures.

5. Establishment of corrective actions to be taken when CCPs exceed set limits.

6. Establishment of record keeping systems to document the HACCP program.

7. Establishment of procedures to verify that the HACCP is functioning properly.

HACCP is described as a management system — designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. The NACMCF committee endorsed HACCP as an effective and rational means of ensuring food safety from harvest to consumption [67]. However, if all of the above criteria cannot be met, then a HACCP plan cannot be established and HACCP may not be the appropriate food safety solution for the process under consideration. This does not mean that process hazards should be ignored but simply that the risks and hazards associated with a process need to be dealt with via an alternative mechanism. Another important aspect of any HACCP program is prerequisite ability to monitor quantitatively critical control points. If one cannot monitor and control important process critical control points then HACCP is not appropriate. Food safety programs such as HACCP and cGMPs are well defined and may function well within the control environs of a food processing plant; however, these food safety program components may not be appropriate in production agriculture situations. For example, as food handling operations move from a confined four-walled food processing facility to a three-walled packinghouse operation and/or back to an open agricultural growing operation, it is obvious that not all cGMPs and/or HACCP requisites could possibly be implemented.

The fresh-cut produce industry strongly believes that HACCP is an effective means of enhancing food safety by control of chemical, physical, and biological hazards that are reasonably likely to occur in the absence of controls. HACCP systems may be considered for intact and fresh-cut produce only when sufficient information and data have been gathered to establish appropriate preventive control measures (FDA, 1998).

It is unclear if HACCP can or should be used as a component of a food safety program for production agriculture. HACCP as currently formulated by NACMCF cannot be used as a food safety program for production agriculture. However, risk reduction and mitigation must be evaluated and implemented in production agriculture to enhance produce food safety. See Chapter 15 for a comprehensive discussion of HACCP.

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