“One audit by any credible third party, acceptable to all buyers” was the goal of fresh produce growers and buyers alike in 2009, when the Produce Good Agricultural Practices (GAPs) Harmonization Initiative began. Led by a Steering Committee of over 30 major fresh produce buying companies, growers and produce trade association staff, the produce industry came together to reduce the audit burden that it had enabled by accepting and supporting a wide variety of food safety audit standards, many of which were the same, adding cost but not improving food safety, and some so contradictory that a grower could pass a food safety audit today and fail tomorrow.

Where We Were
For the initiative to be successful, the Steering Committee established that the “Harmonized Standards” should be focused on food safety and prefarm gate operations, consistent with the scope of the U.S. Food and Drug Administration (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 potential hazards addressed in FDA regulatory guidances

•    A standard that is scalable to fresh produce operations of all sizes

•    Requirements that recognize and take into account regional- and commodity-specific food safety needs

•    A standard that is sufficiently nonprescriptive to accept equivalent food safety practices

•    Requirements that are acceptable to a critical mass of customers requiring general produce food safety audits

•    A standard that is freely accessible for nonproprietary use by any producer, buyer or auditor

•    A standard that is flexible enough to adapt as science reveals better practices and limits

A Technical Working Group (TWG) was formed, comprising over 150 volunteer technical experts in the areas of food safety and growing and handling practices for a wide variety of commodities and growing regions. In face-to-face meetings over 5 months, supported by a variety of grower and buying organizations that hosted the meetings, the TWG reviewed 13 commonly accepted fresh produce food safety standards, identified the commonalities and selected the words from each that best suited a common standard, without sacrificing any food safety considerations. Recognizing that GAPs audits can extend from the field through on-farm processes like cooling, storage and transportation, the TWG split the standard into two. The results were the Field Operations and Harvesting Harmonized Food Safety Standard, applicable to all field operations and greenhouses, and the Post-harvest Harmonized Food Safety Standard, applicable only to those growing operations that have such facilities on-site.

Once the standards were drafted, teams of auditors and buyers field-tested them at over a dozen volunteer operations, many of which had not been involved in drafting the standards, ranging from large operations to the smallest family operations, and for commodities as diverse as potatoes, berries, leafy greens and citrus. These “pilot audits” resulted in a few changes to the draft standards, but everyone involved agreed that the Harmonized Standards achieved the para-
meters of the Steering Committee and could replace all of the GAPs food safety audit checklists currently in use.

Where We Are
Operations Committee and Standards Policies. The Steering Committee recognized that completion of the Harmonized Standards would not be sufficient. To be sustainable beyond their initial use, policies and procedures would need to be established for how the standards 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 standards, how audit organizations would access and be trained on the standards, how disputes about the interpretation of the standards would be managed and how revisions to the standards would be managed. The Operations Committee completed its charge in five short meetings, concluding the following: The Harmonized Standards will continue to be “owned” by the industry, represented by the TWG, which will remain a volunteer organization of fresh produce stakeholders. United Fresh Produce Association, which had coordinated the efforts from the beginning, will serve as Secretariat for management of the Harmonized Standards.

Official versions of the Harmonized Standards will continue to be freely accessible and downloadable from the United Fresh website. Audit organizations that choose to offer audits using the Harmonized Standards will sign no-cost licensing agreements with United Fresh, confirming that 1) they will use the Harmonized Standards verbatim, 2) all auditors performing audits to the Harmonized Standards will be trained using official, uniform training materials and 3) any unresolved disputes between auditors and auditees of how the standards are to be interpreted will be brought to a “Calibration Committee” (see below) for resolution.  

The Operations Committee agreed with the TWG not to restrict the audit process used by an audit organization, that is, how the organization chooses, trains and manages its auditors, how it performs the audits, how it decides “pass/fail” certification or scoring of an operation and how it manages corrective actions and audit reports. While the TWG was successful in achieving the Harmonized Standards, most agreed that achieving the same success in harmonizing audit processes was not possible at this time, and decided to leave judgment on the “right” audit process to individual audit customers.

Recommendations for changes to the Harmonized Standards can be submitted by anyone at anytime to United Fresh, which will coordinate first with the Calibration Committee, then with the full TWG to determine whether the recommendation would be best considered through on-site frequently asked questions, or by formally changing the standards.

The Operations Committee considered whether riders (those additional items added to audit checklists, usually unique to and at the request of specific buyers) should be prohibited when using the Harmonized Standards. After all, the buyers, growers and auditors had all agreed to what was required to assess whether an operation had implemented an effective food safety program; why add more to the checklist and risk going back to multiple standards? However, the committee realized that the initiative did not have the authority to tell buyers what they could and could not require in an audit, and trying to do so would only serve as a barrier to the use of the Harmonized Standards. So ultimately riders were permitted, with the recommendation that anyone requiring a rider submit it to the TWG for consideration; if the rider is necessary for food safety, then it should be incorporated into the Harmonized Standards.

Who Is Accepting Audits to the Harmonized Standards? With the Harmonized Standards finalized and published, and the operating policies and continuous improvement established, members of the Steering Committee were asked, “Will you endorse audits using the Harmonized Standards?” Many had no conditions, but some did: Some buyers required the audits to be done by specific organizations, for example, a government auditor; some buyers required the audit to be performed under a Global Food Safety Initiative (GFSI)-benchmarked scheme and some had riders. All of these were audit process conditions, and all of the produce-buying companies on the Steering Committee agreed that they would accept audits using the Harmonized Standards under their conditions. According to Bill Pool, Wegmans manager for produce safety, “Wegmans Food Markets has actively encouraged our suppliers to use this standard for their audits. We have found that it works quite well for most farming operations, and I’ve got folks ranging from a 1-acre organic heirloom tomato grower to a 500-acre conventional multicrop vegetable grower using the Harmonized Standard. And I’ve got some greenhouse growers using it as well. Of all the audits done last year for our local growers, about 75 percent of them used the Harmonized Standards.” Charlie Cook, president of Country Fare Consulting LLC (CFC), retained by Subway to manage its produce supply chain vendor auditing program, says, “CFC has been using the Harmonized Standards for the past 2 years, and we wholeheartedly support the use of this standard by produce suppliers. The Harmonized Standard incorporates FDA guidance and best industry practice into one understandable document supporting the production and supply of safe produce nationally, thereby reducing the number of audits.” Other major produce buyers, not on the original Steering Committee, were also asked whether they would accept audits using the Harmonized Standards. Invariably, upon being informed of how the standards were created and tested, and seeing them for themselves, every produce-buying company approached has said yes. Again, some have conditions to their acceptance, the same as mentioned above, so operations are encouraged to talk with their buyers before scheduling an audit. But the extent of acceptance among buyers means that an operation should already be able to reduce its audit burden to only a few and, in some cases, one per year (Figure 1).

Who Is Auditing? All major audit organizations identified by the TWG as performing GAPs audits in the U.S. were approached early in the harmonization initiative to become involved and provide their audit checklists. Almost all agreed and have been strong supporters of the Harmonized Standards. According to Ken Petersen, head of U.S. Department of Agriculture (USDA)’s Agricultural Marketing Service, Fruit and Vegetable Program audit section, “USDA played an active role in helping the industry develop sound harmonized GAPs and GHPs [Good Hygiene Practices] produce standards. We were also among the first to perform audits using the Harmonized Standards, which helps ensure that American produce food safety criteria are met. Many retailers specifically request harmonized GAPs audits, so we work with fruit, vegetable and specialty crop suppliers of all sizes to verify their on-farm practices meet or exceed the standards, and we’ve seen many growers successfully migrate to the harmonized audit.” A more targeted audit organization is Equicert, which primarily serves small “horsepowered” farms. “After 2 years’ experience, I’m still amazed by the strength and flexibility of the Harmonized Standards,” said Michael Hari, president of Equicert. “Where other standards may be a poor fit for a certain size farm or a certain geographic area of the country, we are continuing to find the Harmonized Standards flexible enough for a wide range of applications and strong enough to address the avoidable risks that all produce farming has in common. Equicert’s experience with the Harmonized Standards has included broad buyer acceptance. We recommend buyers and growers upgrade to the Harmonized Standards in preference to the old standards.” (Figure 2).

GFSI and the Harmonized Standards. GFSI was created in 2000 as a harmonization initiative. Like the produce industry in the U.S., European retailers were being criticized by their processed food suppliers for creating an audit burden: multiple, redundant and often conflicting audit requirements. In order to accept audits from organizations they didn’t know, the retailers created GFSI to establish a set of guidelines for audits and audit organizations, and to serve as an independent “benchmarking” authority. The retailers’ view: If an audit organization is managed to these guidelines, we can accept their food safety certifications with confidence. The strength of GFSI is its guidelines for how audit organizations manage their audit process, particularly in how auditors (“certification bodies”) are overseen. GFSI also established guidelines for food safety standards for processed foods, developed by several multinational processed food companies using generally the same approach as used to develop the Harmonized Standards. GFSI, and participating audit organizations, continued to grow over the next decade and eventually took hold in the U.S. About the same time, GFSI decided to establish guidelines for food safety standards for “Farming of Plants.” Aware of this, the TWG evaluated the Harmonized Standards against the GFSI guidelines and concluded that, although the words were different, the two were consistent in their expectations, perhaps requiring a few “GFSI riders” to the Harmonized Standards.

Ironically, this is where the two harmonization initiatives came into conflict. U.S. retailers, trying to reduce the audit burden on their suppliers, endorsed GFSI, some requiring all of their suppliers to become certified to a GFSI-benchmarked standard. This created a dilemma for a number of produce companies that had already been audited to the Harmonized Standards, only to be told those standards weren’t going to be accepted because they had not been certified by a GFSI-benchmarked organization to a GFSI-benchmarked standard.  Meanwhile, GFSI benchmarking evaluates both the audit standard and the audit process, so the Harmonized Standards, being just an audit standard, cannot be benchmarked without an associated audit process.   

The solution was to pair the Harmonized Standards with an already-benchmarked audit process. Three of the audit organizations that had been benchmarked to the GFSI Guidance Document 5 were asked about adopting the Harmonized Standards, and two responded.

GlobalG.A.P. already had a process in place that seemed to align with the GFSI guidelines: Recognizing regional and language differences around the world, the GlobalG.A.P. process allows for National Interpretation Guidelines (NIGs) to translate their established standards into the language and special conditions of the country. A GlobalG.A.P. U.S. National TWG was formed, also coordinated by United Fresh, to develop the U.S. Fruit and Vegetable NIG. It didn’t take long to see that the GlobalG.A.P. Integrated Farm Assurance standards, which cover much more than food safety, far exceeded the scope of the Harmonized Standards. However, recognizing that the U.S. produce-buying market is more focused on food safety and less on standards for worker welfare and environmental stewardship than elsewhere in the world, GlobalG.A.P. created a shorter “Produce Safety Standard,” including all, but only, the GlobalG.A.P. food safety requirements. The GlobalG.A.P. U.S. National TWG compared the Harmonized Standards against this standard and demonstrated they are very close in their requirements, requiring only a few “GlobalG.A.P. riders” to be equivalent and consistent with the GFSI guidance. In early 2012, GlobalG.A.P. accepted the U.S. Fruit and Vegetable NIG as official, allowing U.S. produce operations to be certified to the Produce Safety Standards using the verbatim Harmonized Standards plus the GlobalG.A.P. riders. As of this writing, the GlobalG.A.P. Produce Safety Standards are being re-benchmarked to the new GFSI Guidance Document 6, but retailers requiring certification to a GFSI-benchmarked standard are accepting the GlobalG.A.P. Produce Safety Standards certificates.

The Safe Quality Food (SQF) Institute took a different approach to adopting the Harmonized Standards. In 2012, SQF reorganized its food safety standards, combining its SQF 2000 standards for processed foods and its SQF 1000 standards for produce growing and handling into a new set of standards aligned with the new GFSI Guidance Document 6. SQF implemented a “Module 2,” covering an operation’s food safety management system and required for all operations undergoing SQF certification. The institute also modified its SQF 1000 requirements into a “Module 7,” covering fresh produce growing and harvesting. SQF submitted these and other modules to GFSI and completed re-benchmarking in late 2012. At this writing, with the bulk of the re-benchmarking process complete, SQF plans to submit the Harmonized Standards, verbatim except for the portions already covered in its mandatory Module 2, to GFSI for benchmarking as an alternative “Module 7H.”

Thus, for operations whose buyers require them to be certified to a GFSI-benchmarked standard, they have two options with the Harmonized Standards, and operations can choose whichever best fits their culture.  

The fly in this ointment, however, is that the GFSI guidelines don’t appear to allow for government auditors to be certification bodies, as the GFSI guidelines require private sector oversight by an accreditation body like ANSI. At this writing, USDA and several state departments of agriculture are exploring ways around this obstacle. If successful, then operations torn between buyers requiring GFSI and government-performed audits can do both with one audit using the Harmonized Standards.

Calibration Committee and Standards Interpretation. A key aspect of the harmonization process was to use the words from established food safety standards to write the Requirements and Procedures of the Harmonized Standards without change. While some editing was done to remove redundancies, the TWG was largely successful in keeping to this process. Additional words and columns (i.e., Verification and Corrective Actions) were included to clarify what was being required and minimize opportunities for “audit creep.” For example, the TWG carefully stated when policies, procedures and records were required to be written, allowing for verbal policies and procedures to suffice when not critical for safe practices, particularly to reduce the paperwork burden at small operations. However, the Operations Committee recognized that misinterpretation and disputes in interpretation of these requirements would still happen and recommended formation of a committee that would be responsible for ongoing review of disputes and interpretation of the intent of the standards.  

Therefore, a Calibration Committee was formed, comprising representatives of various audit organizations that intended to use the Harmonized Standards and representatives of various commodity growers and buyers (Figure 3). By bringing as many audit organizations as possible to the table and adding subject matter experts in different growing and handling practices, the goal is to further harmonize auditors’ interpretations of what is expected at an audited operation: what practices are “compliant” with the intent of the Harmonized Standards; what practices are not; and how auditors are to react when they see practices they believe may represent a public health risk. The committee’s responsibilities are to 1) develop the official training materials for auditors on how to interpret the intent of the standards and 2) participate to resolve real-time disputes in interpretation of the standards. Importantly, it is not the committee’s responsibility to train auditors how to audit; that task remains the responsibility of the individual audit organizations.

Coordinated by United Fresh, the volunteer members of the Calibration Committee have had their work cut out for them: They’ve evaluated dozens of dispute questions and developed consensus responses to each; they developed training slides for each requirement in the Field Operations and Harvesting standards, including hundreds of possible scenarios of what an auditor might see, often drawn from the dispute questions, and how the auditor should react to and judge what he or she sees; and they offered two Train-the-Trainer workshops in 2012 for auditors and auditees alike—one at Costco headquarters in Issaquah, WA, the second at the USDA National Agricultural Library in Beltsville, MD. Thanks to the generous support of several of the Calibration Committee member organizations, both workshops were offered at no fee to attendees, and both were filled with over 70 attendees each. The participating audit organizations, including USDA, Equicert and some who are GlobalG.A.P. and SQF certification bodies, subsequently began training their auditors, greatly increasing the capacity for operations to have an audit performed to the Harmonized Standards.

Harmonized Standards and the FSMA Rules. At this writing, FDA had just published its proposed rules for Produce Safety and Preventive Controls for Human Food. The scope of the Produce Safety proposed rule is the same as the 1998 FDA GAPs Guide and the Harmonized Standards: the growing, harvesting and on-farm handling of fresh produce. While there may be substantial changes to both rules before they’re finalized by FDA some months from now, a quick read reveals that operations in compliance with the Harmonized Standards will largely be in compliance with the requirements of the Produce Safety proposed rule (the Produce Safety proposed rule includes some numerical standards and testing requirements for agricultural water and soil amendments that the Harmonized Standards leave to individual operations to establish). Meanwhile, FDA has asked for comments in the Preventive Controls for Human Food rule whether handling and processing operations, including those handling fresh produce, should be required to have a Supplier Approval and Verification program; if included in the final rule, this would virtually mandate audits of fresh produce operations. Even if the pending and finalized rules have requirements that exceed the Harmonized Standards, the process for continuous improvement—that is, an annual review by the TWG—provides ample time for adjustment of the Harmonized Standards before the rules are enforced by FDA.

Where We Go from Here
The Harmonized Standards have already found use beyond audits. The On-Farm Food Safety (OFFS) project (http://onfarmfoodsafety.org), created by FamilyFarmed.org with the help of a USDA grant and a Technical Advisory Committee, is a free, web-based program designed to help small operations develop and implement on-farm food safety plans based on user input. “The Harmonized Standards are the basis for our On-Farm Food Safety online tool, which gives growers the opportunity to create a customized food safety plan,” says Jim Slama, president of FamilyFarmed.org. “It’s great to have one standard that meets most of the relevant food safety auditors’ needs, and some growers using the tool have met the needs of multiple buyers and certification needs. The tool has been a great success. In the past year, there have been 12,033 unique visitors to the OFFS website and nearly 300 food safety plans have been completed or are near completion. As of December 2012, approximately 900 users have started a food safety plan based on the Harmonized Standards.”

Experience has shown that more and more produce customers are requiring audits of their suppliers, including small and local suppliers, and that customers are realizing the costs of redundant audits are adding to their own costs, regardless of who pays for the actual audit. The broad acceptance of the Harmonized Standards by major produce buyers seems to show a road forward to meeting the industry’s objective of reducing the audit burden without sacrificing safe produce growing and handling practices. Even while some buyers have restrictions on who can do the audits, having one checklist for all audits has to reduce the audit burden of differing standards. Further, the expectation is that buyers, seeing the same audit results from different audit organizations, will eventually accept an operation’s existing audit results without requiring another, thereby further reducing the audit burden. When they see different audit results for the same operation, using the same standards, from different audit organizations, questions will come back to where they rightfully belong—the audit process—and the marketplace will begin to weed out the poor performers.

However, we’re not there yet. Several suppliers have complained that the Harmonized Standards just added another audit to the list. Why? In some cases, the problem has been with the customer, when the customer’s food safety department, which decides which audits to accept, is disconnected from the produce buyer, who has only a tick box of which audits are acceptable. In other cases, the problem has been with the supplier that is unwilling to ask, let alone challenge, whether the customer would be willing to accept its existing audit using the Harmonized Standards. In both cases, suppliers are encouraged to talk with their customers. If a supplier has a customer unwilling to accept audits using the Harmonized Standards, the supplier is encouraged to contact United Fresh to assist in working with the customer. Wisely handled, a supplier already should be able to reduce the number of audits it needs to endure to just a few, if not one.  

In still other cases, the supplier is comfortable with its existing audit company that doesn’t use the Harmonized Standards, and all its customers already accept the single audit it has. The objective of the Produce GAPs Harmonization Initiative has always been to reduce the audit burden, not add to it, and these were not the types of operations that the Harmonized Standards were developed to help. If all of a supplier’s customers have been satisfied with a single audit performed to a different standard, then we see no advantage to the operation’s changing the audit it uses. But this is not the norm. As operations grow and diversify their customer base, experience has demonstrated that customers’ audit requirements will be different. For them, the Harmonized Standards offer a

For more information about the Produce GAPs Harmonization Initiative and the Harmonized Standards, please visit
www.unitedfresh.org/gap_harmonization or contact Dr. David Gombas, coordinator for the initiative, at dgombas@unitedfresh.org.

David E. Gombas, Ph.D., is senior vice president, food safety and technology, at the United Fresh Produce Association. He provides food safety, microbiology, regulatory and public policy assistance for the fresh and fresh-cut produce industry. He has numerous publications on food safety and is co-editor, writer or technical reviewer for seven commodity-specific food safety guidelines. David is currently coordinator of the Produce GAPs Harmonization Initiative and the U.S. National Technical Working Group for GlobalG.A.P., and serves on the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). David received his B.Sc. degree in food science from Rutgers University, his M.Sc. degree from the Massachusetts Institute of Technology and his Ph.D. in food microbiology from the University of Massachusetts. He has held food safety and microbiology positions with the National Food Processors Association, Campbell Soup Company, Kraft Foods and the National Center for Food Safety and Technology.