The last installment of Western Growers' comment to FDA on preventive food safety controls for fresh produce. Hank Giclars again shows strong command of the issues, and casts doubt on the usefulness of mandatory product testing.

Microbial testing;

The produce industry routinely employs microbial  testing to measure irrigation water quality, verify wash water sanitation practices and measure the effectiveness of equipment and facility sanitation practices. This testing is born out of the  requirements to verify that management practices employed to address specific risks are functioning and effective.

 If irrigation water, compost or the sanitary condition of equipment are identified as potential risks and management practices are  employed to address those risks then testing to verify the efficacy of  those practices is the logical next step in specific, measurable and verifiable programs.

FDA should encourage industry to utilize  microbial testing as a tool to verify specific risk management practices.

That said, industry would benefit from additional guidance in how to select and implement testing programs. It is important that tests have appropriate selectivity and sensitivity for the target organisms, the sampling method and frequency are appropriate to provide confidence when verifying practices, appropriate indicators and or targets are established to evaluate practices and testing be tailored to provide the necessary information for evaluating performance and efficacy.

This means that in select situations a specific test for E. coli O157:H7 may be appropriate and in other instances testing for generic E. coli or simple ATP-based bioluminescence tests may yield desired results. Similarly, testing frequency should be determined based on the risk, management practices and historical data the operator or the industry has available.

For example, a leafy greens grower using sprinkle irrigation from a deep well that has been tested monthly for 3 or 4 years without a significant generic E. coli test might in addition  to a sanitary survey for their irrigation system, choose to manage the risk of irrigation water contamination on their farm by using a generic E. coli test at the beginning of each season.

 Alternatively, that same leafy greens grower growing on a different ranch and using an on-farm reservoir to irrigate the crop and has historical data showing fluctuating populations of generic E. coli throughout the season might chose to manage the risk of irrigation water contamination by tailoring his testing frequency to the closely monitor the water during periods where data indicate conditions might increase risk. In the end, the type of test used and the sampling protocols employed need to be tailored to the situation and cannot be generally defined by rule.

As described earlier, FDA can assume leadership of this process by developing a  mechanism to recognize food safety standards developed by various commodity groups, associations, etc. In addition, the technology for pathogen testing is evolving rapidly in both the private and public sectors and the promulgation of rules for testing may prevent new innovations in testing from coming to market or cause FDA to modify rules to accommodate new technologies.

Western Growers recommends that FDA offer guidance to accompany any requirement to use microbial testing to verify best practices to help producers develop or enhance testing programs and seeks the opportunity to work with industry and FDA to prepare such guidance. The current industry discussion surrounding microbial testing is dominated by a debate regarding the value of raw and/or finished product testing, where that testing occurs within the supply chain and what the test results mean and how they may be utilized.

Producers and buyers have developed raw and/or finished product testing programs for pathogens and employ these tests primarily with commodities that have been historically linked to illness and outbreaks. At the same time, FDA and USDA have implemented testing programs that is likewise focused on these commodities.

These pathogen specific tests present a unique set of  challenges and concerns including the time and cost to confirm a positive result, the disruption that occurs when a positive result is found on product that is within the commercial pipeline, the statistical reliability that these isolated positives are indicative of a contamination event, and the inference that this testing protocol assures safe product all the time.

It is an idealistic although unrealistic proposition to believe that a system could be developed with current technology where mandatory  product testing would assure complete safety of produce prior to sale/distribution. Time is one of the single most important considerations in the produce industry. From harvest to sale at retail and/or food service outlets the industry strives to minimize the time as fresh fruits and vegetables are perishable commodities that have limited shelf life.

 As buyers demand finished product testing the industry struggles to develop programs that will accommodate these specifications and still deliver high quality products. Rapid testing is typically employed but these tests are not infallible. There may be “positives” that are missed as well as “positives” that are false. While it goes without saying that missed positives are problematic, a positive from a rapid test that has not been confirmed (presumptive) is also troubling.

While some would suggest that this product should be destroyed or diverted from the fresh market based on these tests that decision has significant economic implications and should not be made based  on (presumptive) incomplete information. To make an informed decision about release, recover or recall a product, operators must confirm these rapid tests using other methods. This is where the time factor again becomes significant. Rapid and then confirmatory testing can take up to 7 days to process.

The loss of 7 days in a perishable commodity results in diminished product quality and often insufficient time left to permit distribution. Both of these losses translate to thousands of dollars of loss in each occurrence.Any delay in a producer’s ability to ship finished products or commodities is undesirable and should be unacceptable whether the testing is driven by buyer or regulatory testing programs. As described finished product testing presents numerous challenges for industry.

These challenges are exacerbated the further down the supply chain that the sample of finished product is pulled. When samples are taken at the distribution center, food service or retail outlet a positive sample dictates a recall even though that sample may not be predictive of adverse health impacts or  indicative of gross contamination. These recalls, which are increasing in frequency, based on the FDA and USDA testing programs and reporting requirements, are unnecessarily undermining public confidence, damaging individual brands and costing millions of dollars.

In field testing is much less disruptive although there are still logistical issues and challenges associated with delaying harvest. As the industry has sought to diminish the adverse impacts of  finished product testing, some have implemented raw  product or pre-harvest testing programs as a strategy to meet select customer requirements for testing.

These testing programs sample and analyze product prior to harvest. It allows adequate time to sample, test and confirm if necessary product in the field and provides much greater control for producers. Even when product harvest might be delayed it is a better logistical and cost alternative than trying to hold harvested or processed products and prevents the need to recover or recall product that may have been distributed. When pathogens are detected in the field the industry has the opportunity to learn greatly from these events by following up in a real time situation to determine potential causes and contributors.

Western Growers believes that the primary focus of food safety programs should be on preventive controls in the form of good agricultural practices. Testing strategies whether in field or with finished product have yet to be perfected such that they can assure the safety of products.

There are numerous controversial and technical issues that must be resolved in moving towards mandatory product testing. These issues include: the  reliability and methodology of the tests themselves, the sampling methodologies that must be utilized, the organisms to test for, the acceptable/unacceptable numbers for discrete pathogens and the consequences of positive samples for a diverse and interconnected supply chain. Even FDA acknowledges that it is not possible to test your way to safety. At this time and state of technical knowledge Western Growers believes that  mandatory testing of finished or in field product  is premature.

That said, this is an issue that remains a key demand of the market. We encourage FDA to collaborate with industry, laboratories and analytical services, academic and research experts to advance the technology and understanding in this arena.

 Post-harvest operations and the role of the current good manufacturing practices in 21 CFR part 110;

It is clear that many of the practices detailed in 21 CFR part 110 have application to field packing, harvesting, packinghouse and cooling operations, i.e. fresh produce operations.  For clarity, grower/shipper or packinghouse practices should simply be referred to as GAPs. As FDA prepares the Produce Food Safety Rule, it can adopt relevant portions of 21 CFR part 110 that have applicability to grower/shipper and packing house operations, e.g. sanitation, worker hygiene, sick worker policies or other areas as appropriate based on genel risk management needs, but they should be termed GAPs when used in this context. In addition,

Western growers contends that cGMPS, while not within the purview of this rulemaking, should also be reviewed and enhanced using collaborative processes and industry and agency data sets and learnings as previously described for the development of improved preventive controls for production and harvest operations.

The safety and  integrity raw agricultural commodity delivered to a processor must be maintained throughout the processing and distribution operations. As is often  stated food safety is only as strong as the weakest link in the supply chain. While there is great emphasis on preventive controls in the field, post harvest operations such as processing, transportation, distribution and retail and food  service handling are equally critical in ensuring a safe product is available for the consumer.

Records and other documentation that would be useful to industry and regulators in ensuring the  safety of fresh produce; and There is a maxim in the food safety arena that “if it is not documented, it didn’t happen.” Food safety programs should be specific, measurable and verifiable and these tenets drive forward the need for documentation in several critical areas.

The first is that of the risk assessment/evaluation itself. Western Growers contends that there are  several discrete risk assessments that are necessary for a strong food safety program  including an overarching environmental risk assessment (as described in several sections above) that becomes the foundation for a tailored food safety program. This risk assessment is the basis for the development and implementation of management and mitigation strategies to address known or identified risks associated with an operation and/or environment. Environmental conditions may change and unexpected events that introduce unanticipated risk may also occur.

To  address these situational changes pre-harvest and at-harvest risk assessments should also be conducted. Each of these assessments should be documented although the level of documentation will not be the same for each. As an example a comprehensive baseline risk assessment should describe all environmental conditions and risks, enumerate the preventive controls to address identified risk and be accompanied by maps,pictures, drawings, company SOPs and other supporting documentation. An at-harvest risk assessment may simply be a log that the product wasvisually inspected during harvest and no defects or potential risks were observed.

This suggests that  the level of documentation needs to be tailored to the practice and to the use of the document. The first example is the foundation for every aspect of a tailored food safety program and adopted preventive controls… the second is a verification that product was visually evaluated for fitness (risk, defect, etc.) during harvest. Growers complain about excessive documentation and it is the single largest burden/cost associated with food  safety programs. Documentation should be focused on providing rationale for preventive controls in the field and then monitoring their effectiveness.

Western Growers believes that FDA in advancing preventive controls should develop or catalogue existing template examples of documentation that can be utilized as models for the industry. ? Strategies to enhance compliance; Compliance with rigorous food safety practices has largely been a function of suppliers meeting buyer demands. This has been problematic at best in the past because it has resulted in a numerous discrete food safety specifications, additional costs, market confusion, audit fatigue, fragmented approaches as well as a host of unintended consequences.

Despite all that, Western Growersstrongly contends that food safety programs in the U.S. fresh fruit and vegetable industries are strong and continue to improve. Today FDA has an opportunity to exhibit a leadership role on the farm through the promulgation of new regulations for preventive controls. It is an opportunity to simultaneously support the fresh produce industry and enhance public safety that can be furthered through a few simple steps: FDA should define the performance standard for all food safety programs including the criteria forcontent and the operational standards by which GAP audits should be performed.

FDA should encourage the industry to develop commodity-specific or regional standards that comport with established performance standard and can then be evaluated by FDA to insure these standards are appropriate.FDA should develop working arrangements with sisteragencies such as USDA as well as with foreigngovernments to allow for verification of food safety programs and practices in production environments.  FDA should provide expedited treatment at ports of n entry for foreign producers that utilize FDAapproved verification services such as through USDA or other governments.

This would encourage FDA oversight in foreign countries.FDA should recognize accredited laboratories sothat growers and handlers who employ microbial testing can participate in a data sharing programas previously described. Those growers and handlersthat share data should be exempted from random market based testing in exchange for their testing data. FDA should engage industry in investigations when contaminated product is found and/or recalls are mandated.

Involving industry experts, sharing data and key learnings from these incidents will expedite investigations and allow for continued and rapid improvement of food safety systems. FDA should work with the industry, academia and other government agencies to develop training programs, materials and resources that enable producers, buyers and consumers to better understand critical food safety issue, implement preventive controls and meet performance standards established by FDA.

FDA should work with industry scientists andacademic researchers in  multiple disciplines to prioritize and focus food safety research to reduce knowledge “gaps” that currently exist. This collaboration should emphasize practical tools that can be utilized in the production environment to address known risks. FDA should compile a comprehensive list of zcceptable food safety practices that can be utilized as a menu of best practices from which  growers can select those that fit their unique operations. These practices should include design  and implementation considerations to minimize adverse or unintended consequences to key  environmental goals.

FDA should recognize industry programs that meet or exceed performance standards established by the Agency.  Western Growers continues to believe that the industry is best positioned to improve and enhance food safety in the fresh produce sector. Industry experts, trade organizations, academics, environmentalists and other interested parties have combined efforts in the past to develop model programs for specific commodities at the request of and with the guidance from FDA. These programs have been grounded in the best available science; include specific and measurable criteria and are complemented by strong verification programs.

In  establishing a new rule – Western Growers believes  that FDA should build on this successful approach by establishing the standards (expected content,  performance levels and verification requirements)  for food safety programs, allowing industry to  innovate to meet the FDA specifications and then recognizing those programs that meet FDA standard criteria. We also believe that to advance knowledge, improve understanding and continue to improve the protective nature of preventive controls FDA must develop and implement mechanisms to include industry as a partner in investigations,surveillance and other learning opportunities.

We encourage FDA to work closely with industry to improve all facets of food safety recognizing that the unique nature of these high value perishable commodities often requires rapid but well informed  decisions which in turn mandates streamlined regulation that focuses on minimizing administrative  burdens and delays. In conclusion, Western Growers is very appreciative of FDAs approach to solicit input on preventive  controls prior to the development of a draft rule. We recognize that this is the beginning of the discussion on mandatory controls for the production  of fresh fruits and vegetables and we are committed to a continued constructive dialogue with FDA and a leadership role within the fresh produce community.


Hank Giclas, Senior Vice President
Science, Technology and Strategic Planning
Western Growers
17620 Fitch Street
Irvine, CA 92614