When it comes to food safety standards, more is not always better. That’s the message from the growers and shippers of fresh produce today who are faced with multiple audits and audit expectations that are almost the same, but different enough, so that an operation can pass a food safety audit today according to one set of standards and fail tomorrow on a different set of standards.
A short 30 years ago, all fresh produce was considered a “raw agricultural commodity,” requiring peeling, washing and other preparation steps before becoming a ready-to-eat food. The only fresh produce food safety risk, as far as consumers were concerned, was pesticides. Retail and foodservice buyers were also concerned about growers’ compliance with pesticide limits, but otherwise were only worried about quality attributes—size, color, shape, defects. It wasn’t until the mid-1990s that the focus on produce food safety began to shift to microbiological concerns—produce could become contaminated with pathogens in the field and cause consumer illness. Then, it wasn’t long before the produce industry itself began developing “best practices” for field operations, and FDA published their Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, more commonly known as the Good Agricultural Practices, or GAPs, Guide. The GAPs Guide recommended that growers and harvesters consider and address potential pathogen hazards from irrigation and other agricultural water, manure and other soil amendments, domestic animals and wildlife and workers and their utensils and equipment. That was arguably the last time there was consensus on what constituted food safety practices for fresh produce field operations.
In the 12 years since the GAPs Guide was published, there have been relatively rare, but still too frequent, illness outbreaks linked to fresh produce. Some, primarily the early events, were clearly attributable to poor practices, particularly hygienic, which resulted in stricter and more clearly worded food safety expectations. Other produce-linked outbreaks could not be linked to specific contamination events, but fresh produce customers and GAP auditors, needing to “do something” to reduce food safety risks, embellished FDA’s guidelines in subtle but important ways. Unfortunately, there was no organization to the changes, and today, there are dozens of produce food safety standards and audits widely used in North America, many with customer-specific additions. This would not necessarily be a problem, but as is also common for processed food operations, many customers have become very particular about which standards and audit companies they are willing to accept. Consequently, more often than not, growers are faced with having to endure, and usually pay for, multiple audits. It is not unusual for a grower to have almost as many audits as they have actual and potential customers.
By 2007, “audit fatigue” had become almost as big an issue in the fresh produce industry as food safety. The costs of these many audits were beginning to be felt by customers as well as by the suppliers. However, customers, wanting to reduce costs by accepting audit reports from other audit organizations, discovered that they could not readily compare one audit report to another because of the different audit standards and audit processes being used. It was at this point that the United Fresh Produce Association Food Safety and Technology Council—over 90 volunteer technical experts from United Fresh member organizations, representing the entire fresh produce supply chain—took on the challenge of finding ways to reduce the audit burden without sacrificing food safety assurance.
Audits Benchmarking Matrix
The first challenge was to understand why some customers would only accept the audits or certifications of certain organizations and not accept the audit reports or certifications of others. For most, the decision came down to trust. Without knowing the audit company, let alone the auditor, how would a customer know whether the certification or audit results were reliable?
One solution offered by the Food Safety and Technology Council was an Audits Benchmarking Matrix—a side-by-side comparison of the audit organizations and food safety standards most commonly used by the fresh produce industry. A working group of the Council, led by Gail Murray of Disney Consumer Products, formulated a series of key questions to elicit information about how the audit and standards organizations managed their auditors and internal procedures to assure the integrity and reliability of their products. The questions intentionally stayed away from the content of the audit checklists or standards, focusing instead on the audit process. The Matrix includes questions like “What is the length of an average audit?” and “List training requirements for new auditors.” Eight organizations commonly used for pre-farm gate (i.e., GAP) audits, seven organizations commonly used for post-farm gate (i.e., Good Manufacturing Practices or GMP) audits and four of the Global Food Safety Initiative (GFSI)-benchmarked food safety standards organizations agreed to participate in the Matrix and provided detailed answers to the questions based on their established policies and procedures. The Matrix was initially presented to the produce industry in 2009 during the United Fresh Global Conference on Produce Food Safety Standards, where over 300 attendees heard and asked questions of the audit and standards organizations about how they managed the quality of their programs. Those answers were formalized and are now offered in a Web-based format on the United Fresh Web site, at www.unitedfresh.org/newsviews/food_safety_resource_center/audits_benchmarking_matrix. As one looks through how organizations answered questions asked about their audits, audit performance and auditors, one of the striking realizations from the Matrix is the similarities among the various programs. For example, when asked, “What program feature most assures the reliability of the audits performed by this company?” all of the audit organizations cited their auditor training and review of audit reports by internal management. Almost all of the programs require their auditors to have prior experience in produce operations or the food industry, and almost all describe periodic “shadow” or “witness” audits, where calibration of auditor performance is verified by other auditors. While there are clearly differences between the programs and how they are managed, one notes that there are mostly commonalties among their core policies and procedures. United Fresh offers the Audits Benchmarking Matrix as a tool to help audit customers decide whether the quality practices of an audit organization are acceptable.
Produce GAPs Harmonization Initiative
Another key realization from the Global Conference on Produce Food Safety Standards was that the standards and checklists used by the different organizations for GAP food safety audits appeared to be more than 95% the same, which seemed to promise an opportunity to harmonize the audit expectations. If the food safety standards and checklists were harmonized across the different groups, then it should make it easier for customers to compare audit results even if the audits were performed by different organizations. It would also allow produce suppliers to follow one set of expectations and not have to make changes to suit the auditor of the day.
However, harmonization of GAP audits has been tried before. In 2007, the Food Safety Leadership Council (FSLC), a coalition of foodservice and retail companies, published a food safety standard for certain fresh produce items. Their intent was to agree among themselves what the expectations would be in order to reduce the number of audits that their common suppliers would need to have. However, rather than gaining acceptance of this noble effort, the FSLC faced strong resistance from their suppliers and the produce industry and eventually abandoned their standard. Why? The produce suppliers felt that the standard had been developed in secret, without their input, and they were immediately and irrevocably suspicious of the standard.
The GFSI was created for the express purpose of harmonizing food safety audit programs or “schemes,” so as to reduce the audit burden on food manufacturers. The GFSI approach is to compare the standards and audit processes of existing food safety standards against the GFSI Guidance Document, now in version 5. Schemes that benchmark successfully are considered equivalent to each other, and supporters of GFSI will accept any audit performed under any of the benchmarked schemes. Two of the benchmarked schemes—GlobalGAP (previously known as EurepGAP) and SQF 1000—were developed specifically as GAP audit programs, and both have been marketed as opportunities to reduce the audit burden on produce suppliers. GlobalGAP, for example, boasts that “more than 100,000 producers are certified against the GlobalGAP or a GlobalGAP-benchmarked standard” in over 100 countries. However, neither scheme has yet achieved prominence in the U.S., despite strong pressure from produce customers who support GFSI. Again, the reasons cited by many U.S. suppliers are that the standards were not developed with their input, and they don’t feel the standards measure their food safety systems well.
Building on these and other prior efforts, the Food Safety and Technology Council offered another solution—the Produce GAPs Harmonization Initiative. The approach offered by the Council was to begin with a Steering Committee of influential produce business leaders, particularly those representing organizations that were requiring their suppliers to have specific food safety audits, and assure that they would agree to accept a harmonized standard if it was developed. Leaders from over 30 organizations agreed to serve on the Steering Committee, representing major produce suppliers, processors, retailers and foodservice companies. Led by Chiquita North America President Brian Kocher, the Committee agreed to the proposal but with some caveats. They formalized their goal of “one audit by any credible third party, acceptable to all buyers” with the following vision: “Develop a harmonized food safety standard and checklist for GAP audits, and globally acceptable auditing process, necessary to protect consumers from potential hazards that may contaminate produce at that stage of the supply chain, and that will build efficiencies into the supplier audit process.” For the Initiative to be successful, they agreed that the standard should be focused on food safety and pre-farm gate operations, consistent with the scope of the FDA GAPs Guide, and identified the following parameters:
• Clearly defined requirements that minimize opportunity for misunderstanding, misinterpretation and “standards creep” by operations and auditors;
• A standard that is globally recognized, but specifically applicable to North American operations;
• Requirements that are risk-based, science-based, attainable, auditable and verifiable;
• Requirements that consider all microbiological, chemical and physical hazards reasonably likely to occur, consistent with those addressed in FDA regulatory guidances;
• A standard that is scalable to all size fresh produce operations;
• Requirements that recognize and take into account regional- and commodity-specific food safety needs;
• A standard that is sufficiently non-prescriptive to accept equivalent food safety practices;
• Requirements that are acceptable to a critical mass of customers requiring produce food safety audits;
• A standard that is freely accessible for non-proprietary use by any producer, buyer or auditor; and
• A standard that is flexible enough to adapt as science reveals better practices and limits.
Wanting to ensure that the process was not delayed, the Committee asked for a completed consensus GAP standard and checklist by October 2010.
Part two of the Food Safety and Technology Council’s harmonization approach was to create a second group to develop the standard. This “Technical Working Group” or TWG would be comprised of food safety, quality assurance and technical experts from each stage in the produce supply chain. Chaired by Suresh DeCosta, McDonald’s Corporation, the TWG was designed to be unlimited in size and be a broadly inclusive group of experts across the industry. As of today, the TWG has over 100 volunteer participants, including representatives from produce growers, shippers, packers and repackers, processors, retail and foodservice organizations, audit organizations, FDA and USDA, from Canada, Mexico and the U.S. and across a wide range of commodities. To ensure transparency, no one who wanted to participate was excluded. Face-to-face meetings, some hosted by companies like McDonalds, Taco Bell, Darden and U.S. Foodservice, were scheduled to encourage representatives of small or regional operations to participate, if only for one meeting.
Rather than create a new standard, the TWG began its efforts by examining similarities and differences in many of the existing GAP standards, recognizing that existing standards already had some level of acceptance. They quickly discovered 60 categories of audit questions common to most of the standards. They invited over a dozen of the more commonly used or recently developed standards to be included in the harmonization process, and 13 of the standards responded. The TWG considered all of these standards for which audit expectations seemed to be common and which wording best met the concept of a harmonized standard for all fresh produce. In 4 monthly, 2-day meetings, the TWG hammered together a first-draft standard. The participants fought the desire to create new standards, relying instead on the more difficult task of selecting words from the established standards. This draft had over 400 line items, covering field production; harvesting; cooling, packinghouse and storage operations; and transportation. Interestingly, initial concerns that the standard would need to be divided into commodity-specific standards did not develop. The TWG discovered that, while food safety practices might be different for different commodities, the audit questions remained the same, allowing the Initiative to move forward with a single standard.
In June 2010, the TWG began phase 2: to revisit the draft wording and, retaining as much of the draft standard as possible, clarify the wording and ensure applicability and completeness for the widest possible range of commodities, size operations, production practices and production regions in North America. First, they divided the standard into stand-alone Production/Harvesting and Post-Harvest modules. Next, they borrowed a format from the recently developed Food Safety Programs and Auditing Protocol for the Fresh Tomato Supply Chain, which included a briefly worded “Requirement,” a lengthier “Procedure” to restate the requirement in other words to avoid misunderstanding, “Verification” actions that would serve as instructions to the auditor in assessing compliance with the requirement and “Corrective Actions” that the operation would likely need to implement if the auditor determined they were not in compliance. Then they went through the draft, one line at a time, culling out redundancies and clarifying expectations. This was the phase that required as broad a range of participation as possible, and many efforts were made to attract as much stakeholder input as possible. The draft standard and summaries of the Steering Committee and TWG meetings were posted and openly accessible on the United Fresh Web site. A blog site was subsequently created, allowing anyone to comment on the wording or intent of any part of the draft standard.
Meanwhile, the Steering Committee recognized that completion of the harmonized standard would not be sufficient. To be sustainable beyond its initial use, policies and procedures would need to be established for how the standard would be managed and maintained. To that end, they commissioned an “Operations Committee.” Led by Wegmans Vice President of Produce Dave Corsi, the Operations Committee was charged with recommending responsibilities for ownership of the standard, how audit organizations would access and be trained on the standard and how both disputes about the interpretation of the standard and revisions to the standard would be managed. As of this writing, the Operations Committee had yet to meet but, with the TWG well on its way to a successful delivery of a completed harmonized standard to the Steering Committee at its September 13 meeting in Washington DC, the Operations Committee will do its best to ensure that a harmonized standard is freely available and consistently used by and for the fresh produce industry.
David E. Gombas, Ph.D., is the senior vice president, Food Safety and Technology, at the United Fresh Produce Association. He provides technical, food safety, regulatory and public policy assistance for the fresh and fresh-cut produce industry. In this position, Dr. Gombas serves as a technical expert and spokesperson for the association during produce-related outbreaks, including the September 2006 E. coli outbreak in spinach and the 2008 Salmonella saintpaul outbreak that was linked to jalapeño peppers. Previously, Dr. Gombas was with the National Food Processors Association (NFPA), where he was vice president of NFPA’s laboratories for microbiology, chemistry and processing research and technical assistance in Washington, D.C. Dr. Gombas also served as vice president of NFPA-SAFE, NFPA’s auditing program for the food industry.