Another key comment by Western Growers to FDA on preventive controls for fresh produce, this excerpt dealing with how the scale of growing operations relates to food safety hazards. WG argues that the experience of the Leafy Greens Marketing Agreement points to proportional  food safety costs for both large and small producers.

The impact of scale of growing operations on the nature and degree of possible food safety hazards

It is clear that all products need to be as safe as possible. A consumer that becomes ill as a result of contaminated product does not care if that product came from a small or large farm; a local  grower or one 3,000 miles away.

The industry and consumer is continually and adversely impacted by any contamination. That said, we continue to see subsets of the industry across the country express their concerns over potential food safety requirements stating they view them as too costly and not necessary.

While some would raise the issue that if contamination occurs on a small farm that distributes locally the scope of the outbreak might be limited. But all contamination events that may occur on the farm can be traced back to small blocks and thus the risk is present regardless of the size of farm. It is  incumbent upon all parties involved in the production and handling of fresh  produce to develop and implement  preventive controls for their operations.

The issue of cost is one that Western Growers recently evaluated in the context of determining the relative costs to implement and adhere to the requirements of the existing state and contemplated national marketing agreements for leafy greens. Arguably one of the most stringent set of requirements in the industry the economic analysis conducted in conjunction with these programs and potential program is instructive for FDA and is excerpted below:

Absent a national marketing agreement, buyers, food service industries, and states will develop and implement their own mandatory standards for producers and handlers– at times for competitive advantage and more than likely not based on scientific data. With a national marketing agreement, the likelihood of producers and handlers being subject to multiple inconsistent requirements is reduced, which in turn should minimize any production cost increases.

 The majority of the leafy green industry is already adhering to the marketing agreements in Arizona and California given the volume of leafy green production in those states coupled with the success of the two marketing agreements in obtaining handler acceptance.

 The California leafy greens industry represents about 75 percent of all the leafy greens produced in the U.S., with 99 percent of that volume already covered by the marketing agreement. The Arizona leafy greens industry represents about 15 percent of all the leafy greensproduced in the U.S., with 90 percent of that volume covered by the marketing agreement.

For those growers and handlers not currently participating in a marketing agreement, the implementation of a NLGMA will result in additional costs for some producers and  handlers. Although the national marketing agreement will differ from the California and Arizona agreements, the costs associated with the state agreements are representative of the costs that could result from a national agreement. For this reason, producer and  handler level food safety costs were evaluated prior to and after the implementation of the LGMA.

Food safety costs prior to the California LGMA were estimated using both the LGMA survey from 2007 and a follow-up phone survey to growers and handlers in California and Washington. Although the number of completed calls was limited, they are instructive  for two reasons; first, the interviews validated the operating costs per acre in the enterprise budgets for romaine and leafy greens from 2004 and second, the interviews provided issing data for  small handlers and growers who do not currently participate in the California LGMA.

Combining costs from both the LGMA survey and the phone surveys, potential costs for small and large growers and small and large  handlers were projected for the implementation of a national agreement. One major finding from the phone calls is that all growers and handlers, both small and large are spending an estimated 1-2% of operating costs on food safety after the implementation of the LGMA. 

In three years of operation with both small and large farms engaged Western Growers has no knowledge of anycompany that has been unable to adapt or has gone out of business as a result of burdensome costs
associated with LGMAs. It is reasonable to assume that the costs to implement FDA preventive controls
will not exceed those of the marketing agreements. Balancing the costs for all producars and handlers are the  anticipated benefits of a unified set of preventive controls.

Those benefits would include grower and handler savings, industry savings, enhanced marketability, and increased consumer confidence. During the USDA hearings on a proposed national marketing agreement for leafy greens, proponents testified that a national marketing agreement would establish consistency in leafy green production and handling practices through the industry supply chain which in turn would reduce  thenumber of diverse programs and audits required by the marketplace.

The savings  ssociated with a single audit program would be significant for  individual growers and handlers. In addition, the ability to prevent additional outbreaks and/or minimize their scale through a strong science-based national food safety program would prevent significant costs to the industry.

Dr. Richards, an economist with Arizona State University, testified in NLGMA hearings that large outbreaks, similar to the 2006 outbreak, could occur at a frequency of one in ten years and the ability to prevent or reduce the frequency would save the industry at large millions of dollars. These economic factors demonstrate that costs for such programs are not prohibitive and that they are indeed equitable and scalable.

 Methods to tailor preventive controls to particular hazards and conditions affecting an  operation; All preventive controls should begin with a focused evaluation of potential hazards or risks and then proceed to the development and implementation of practices, protocols, tools, methodologies or controls that will minimize, mitigate or eliminate those risks. These preventive controls can include everything from measuring the level of sanitizer used to disinfect a piece of equipment to standard operating procedures that outline the steps for performing a risk assessment or documenting corrective actions in the field.

The industry has been aggressive in recent years  developing various commodity-specific guidelines and growers and handlers have sought greater specificity in what to evaluate, look for, measure and document in an effort to improve and demonstrate food safety in the production and handling sector. As previously pointed out, Western Growers recommends that FDA engage in the development and/or validation of best practices and metrics in an effort to provide a suite of practices and recommendations that users could select from when attempting to incorporate preventive practices to address identified risk within their operations.

That said, Western growers also fundamentally believes that the entire process begins with risk assessment conducted by the grower and or handler and that the design and selection of preventive controls are best identified by these individuals such that they are tailored to their operations. They know their operations intimately and are best positioned to identify risks and develop best practices and/or preventive controls to manage those risks. This approach leverages the creativity and innovation of the industry, enhances practicality and implementation in the field and facilitates FDAs continued oversight in the development of discrete programs.

 Additionally, it positions both the industry and agency to respond rapidly to evolving science of produce food safety. Western Growers reiterates our recommendation that FDA work directly with industry to organize materials into useful tools that could accompany an FDA rule for preventive controls. These materials would be designed with collaboration fromextension, industry, academic and other interested parties, centered on the importance of and how to conduct a risk assessment and proven technologies and practices that may assist in managing identified risk. 

Possible approaches to tailoring preventive controls to the scale of an operation so that the controls achieve an appropriate level of food safety protection and are feasible for a wide range of large and small operations;Risk exists on large farms and small ones across the country and regardless of the commodity produced or region in which a commodity is produced. With food safety costs estimated to be 1-2% of total production costs it is clear that large growers will spend more money to implement comprehensive food safety programs.

That nenhanced food safety comes with a costto both small and large growers is undeniable. But it is critical for operations of all sizes to have risk-based food safety programs. These costs can be addressed and minimized by sharing information, providing tools and by facilitating training.Western Growers stands ready to work with FDA to provide these tools and training to any grower in an effort to alleviate any anxiety that may be causing them to resist the implementation of  preventive controls in their operations.

The goal has to be improved food safety performance for the entire industry. It has been our expeience, borne out in both the development and implementation of the LGMAs and in the distribution and implementation of other commodity specific guidelines and programs, that once growers understand the concepts of hazard analysis and management, they come to understand that very simple practices that are not expensive to implement can be effective preventive controls. Indeed, often they are just good operational or business practices.

For example, a preventive control that can help insure against contamination of product is a simple at harvest visual inspection of product during harvesting. In larger operations this may require some training for harvest crews in  smaller operations it may be the grower themselves that examines product as it is harvested. Regardless of size, any grower would want to ensure that they were not including suspect product in their harvested and marketable produce.

When more costly preventive controls such as microbial tests or food safety audits might be required or utilized as a verification tool there may be methods for growers to collaborate to gain economies of scale that can then reduce the per unit costs for these services. While it is not prudent for FDA to prescribe preventive controls regardless the size of the grower, a grower based on their specific risk assessment should be free to employ preventive controls based on what works economically and practically for their operation. FDA guidance in this area to assist growers in selecting these practices is necessary and strongly recommended by Western Growers.