Here is the second part of Western Growers' comment to the FDA, this concerning the role of GAP guidelines.

Response to Specific Questions:

Role of the good agricultural practice guidelines entitled ‘‘Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables’’ (GAPs Guide, Ref. 6); The FDA “Guide” is an effective and useful tool for identifying and focusing attention on the core areas of risk associated with fresh produce operations. There are eight discreet sections that are widely accepted as potential areas of risk and addressing each of these areas is critical for any/all preventive programs.

The “Guide”, also appropriately articulates the scope of preventive programs by including all fresh fruits and vegetables, all operations (large and small, raw and processed) and the key production operations that must be included. In addition to articulating the key areas of risk, defining the scope of a preventive program(s), the “Principles” within the “Guide” effectively outline the tenets upon which any fresh produce preventive program and developing rule should be constructed. Paraphrased, those principles include the following:

• Prevention of microbial contamination should be favored over reliance on corrective actions,

• Growers, packers, or shippers should use good agricultural and management practices in the areas they have control,

• Contamination may occur at any point along the farm-to-table food chain;

• The major source of microbial contamination is associated with human or animal feces,

• The source and quality of water that contacts produce dictates the potential for contamination,

• Use of animal manure or municipal biosolid waste should be managed closely,

• Worker hygiene and sanitation practices play a critical role in minimizing the potential for microbial contamination,

• Local, state, and Federal laws and regulations, or corresponding or similar laws, regulations or standards for operators outside the U.S. must be  followed,

• Accountability is important to a successful food safety program,

• Qualified personnel and effective monitoring must ensure that all elements of the program function correctly and to help track produce.


Western Growers believes the strength of the “Guide” is that it provides a clear direction for the scope of regulations, the key risk areas that must be addressed and several key tenets that must be observed and adhered to in  development of a rule. That said, we also have offered specific feedback to FDA on the “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” in previous comments from Western Growers.

While we will not reiterate these comments in totality, it is important to emphasize that while generic guidance is important to provide direction, considerations, recommendations and options to the affected industry it does not provide clarity regarding the specific criteria by which an operator would be deemed compliant or in violation
of a practice or standard, establish clear performance targets for the industry or practical strategies to address acknowledged areas of risk. While the “Guide” provides for maximum flexibility on the farm (which is critical) it also leaves in question the key critical control points, mitigation strategies and metrics that growers seek when attempting to develop specific preventive  programs.

The “Guide” is written to be a non-binding document that is representative of the “current thinking of  FDA and USDA on a number of microbial food safety hazards and on good agricultural and management  practices.” It is written to provide the basis for further development of discrete programs that are tailored to individual operations and/or commodities. In essence, it is to be used as a platform for further development of more specific good agricultural practices that reduce risk and minimize/prevent potential contamination in unique settings. Development of acceptable approaches to addressing risk areas has been principally left to industry practitioners and food safety experts from academia.

 Western Growers believes that approaches deemed to be protective/preventive should be itemized and catalogued by FDA in guidance so that producers may select from (what could effectively become) a suite of approved practices. The varying approaches – in synch with FDA’s “current thinking” could facilitate the implementation of tailored (scalable, commodity, region specific) programs that were protective/preventive while at the same time  ensuring that key areas are addressed and that flexibility is maintained for growers.

 It is similar to the approach that USDA NRCS takes to conservation issues – there are a series of approved best management practices that may be utilized to address a specific conservation issue … growers select approaches that work within their discrete operations from an approved list of validated BMPs.

In addition, FDA might review, approve and add to the list any alternative approaches brought forward by industry (or others)  if that alternative effectively served to reduce microbial hazards that could result in foodborne illness and satisfied applicable statutes and regulations.

 Western Growers recommends that the appropriate role of the “Guide” remains to establish and communicate the current thinking of the FDA as to the scope, key areas of risk and guiding tenets for food safety in fresh fruits and vegetables and that role be expanded to include guidance on acceptable strategies that may be employed to address each area of risk. With the “Guide” forming the basis of current thinking on risk and best practice it could be fundamentally utilized as the basis for any food safety program and to evaluate specific programs.

 Standards for domestic and foreign growers and packers; With respect to the safety of food, and specifically fresh fruits and vegetables, the origin of the product does not matter. Consumers expect a safe high quality product with nutritional and health benefits. Every fruit or vegetable consumed in the U.S. should be produced under food safety standards that have the same degree of rigor, address identifiable risk, based on the best science available and allow for verification. Western Growers does not believe that varying standards are in the best interest of the industry  or the public at large.

They drive cost into the production of food, create confusion in the supply chain and  marketplace and the resulting chaos breeds both “audit fatigue” and tenuous consumer confidence. Consistent,  uniform, equivalent standards must be established for all parties including all foreign and domestic growers. This raises the questions of what is a “standard” and how should FDA work to ensure that standards are uniform,  consistent and equivalent across diverse production regions, commodities and types (including size) of operations. Common themes in the discussion of food safety regulation include “one size doesn’t fit all” and “there are too many “standards”.

 This dichotomy of opinion stems from the fact that industry needs the flexibility to tailor programs  so diverse situational needs  (commodity, region, scale, etc.) while at the same time having numerous ideas, concepts, programs on  how to do that and what is best. It seems prudent that FDA act to develop definitive structure and criteria for food safety programs such that there is a defined “standard” that dictates the content of programs and the methodology by which they  will/can be verified.

This is a core tenet of Western Growers work in the area of food safety -  that programs should be specific, measurable and verifiable – and FDA should communicate their expectations for both content and verification in the form of a defined standard. In turn this leaves flexibility for industry to develop specific programs that comport with a uniform FDA standard. In essence, the development of a uniform FDA standard for food safety programs that dictates both content and assures appropriate verification will develop a road map for industry to develop and refine existing programs, allow for FDA to evaluate those programs against their criteria/standard and then to recognize those programs that measure up to an established benchmark.

To approach the issue of developing preventive controls for fresh produce in this manner is to facilitate the collective collaboration of industry (including growers, handlers, academics and food safety experts) and the FDA in the pursuit of the strongest most protective food safety programs while at the same time ensuring ownership and practicality for the industry.