Here is part one of the comment that Western Growers submitted to the FDA on preventive food safety controls for fresh produce. .

July 23, 2010

Western Growers is a non profit trade association representing growers and handlers of fresh fruits, nuts and vegetables produced and shipped from the states of California and Arizona. Our members produce about half of the total U.S. output of fresh produce for sale in the United States and beyond. In addition to growing and handling products from California and Arizona, many of our members source products from other states as well as internationally in an effort to be year round suppliers of wholesome, nutritious, safe produce.

Western Growers has been a leader in the development and advancement of food safety programs, practices and prevention strategies. Our membership is committed to our active and engaged representation of their interests in the marketplace, academic and regulatory arenas. Western Growers has been a champion of strong food safety programs oriented towards prevention of possible contamination in the field, quick and decisive reaction to remove potentially contaminated products upon discovery and aggressive follow up to learn from discrete events and improve food safety systems, practices and programs in an effort to reduce the likelihood that individual consumers of fresh fruits, nuts and vegetables will fall ill because of foodborne contamination.

We are very appreciative of the Food and Drug Administration’s effort to solicit industry opinion and input up-front as they move to develop a mandatory program (rule) that will help prevent foodborne illness associated with fresh produce. We firmly believe that strong collaboration between academic, regulatory, industrial and public sectors are necessary to create a program or series of programs that is protective and practical. The FDA’s outreach to these diverse interests in the initial stages of developing a rule is both laudable and appreciated.

In our effort to constructively participate in this outreach Western Growers is submitting the following general comments as well as responses to the questions outlined in the FDA request for comments on Docket No. FDA-2010-N-0085, “Preventive Controls for Fresh Produce”. We are committed to working with the FDA to help perfect rules that will enhance food safety for both growers and consumers of fresh fruits, nuts and vegetables and remain practical, accessible and implementable in the field. To that end, we offer the following guiding tenets for fresh produce rules:

Food safety is critical to every individual grower and every individual consumer. There is risk in every production environment regardless of the crop or the size/scale of the operation. Outbreaks have been associated with farmers markets as well as large distribution systems, they have been associated with food service as well as retail products, they can occur with raw agricultural commodities or fresh processed product. When it comes to protecting the individual consumer - it is incumbent upon every producer whether they are selling into a large multi-state distribution system or simply for a farmers market or CSA program that they employ a food safety program that addresses the risks associated with their operation and that they be able to verify the programs and practices they employ.

NO Exemptions
Resources are scarce and most fresh produce producers and handlers operate on slim margins. That said it is critical that the outlay of resources be optimized where it may return the most to investment. Western Growers believes the optimal system is one focused on prevention. This means that systems that evaluate and prioritize risks, identify potential strategies to reduce, minimize or control those risks and then monitor performance of those strategies/controls are the most effective means of enhancing food safety. In short, systems should be preventive in nature. This is far more important than reactive strategies that seek to evaluate finished products for their safety or retrieve suspect product after sale.

Focused on Prevention

To ensure that food safety programs are as protective as possible, requirements (standards/metrics) must be clearly worded and reasonably specific. Ambiguity is the enemy of strong food safety practices and leads to subjective (mis)interpretation by auditors, producers and others. In order to be specific and clear “metrics” must address actual sources and pathways for potential contamination as well as provide strategies for possible methods to reduce/mitigate those risks. The adage of “specific, measurable and verifiable” applies wholly to food safety requirements that may be codified by FDA. To ensure that requirements are grounded in science Western Growers believes that all standards should be subject to rigorous review by agricultural, regulatory and academic experts from a variety of disciplines.

Science Based Metrics

Since the body of knowledge and understanding regarding food safety in produce systems is rapidly expanding and may yield significant insight into how contamination may occur within the supply chain and how better to prevent or reduce the potential for contamination it is critical that any rule be designed to provide for the incorporation of new practices, technologies, metrics, etc. It is also advisable that to facilitate continual improvement, requirements be routinely reviewed by experts and changed to reflect new science and data as it becomes available. This will ensure that the best available science is applied to risk reduction activities.


Food safety programs and requirements should be developed, updated and maintained through a transparent and participatory process, including the early and full participation of appropriate stakeholders, such as producers, scientists, conservationists, agencies, consumers, etc. This will assist in assuring that programs and practices are science-based, focused on known risks, and are achievable in the field and plant environments. It will also help to ensure compatibility and reduce conflict with other regulatory programs as well as foster broader public health and safety efforts. To achieve this, FDA should develop structure and programs to engage cooperation among scientists, agencies, growers, produce industry representatives, auditors, conservationists, etc. A technical advisory committee similar to those deployed in other federal agencies might be very useful in this regard.

Transparent, Accessible, Participatory

There are close associations between food safety in a fresh produce operation and the environments in which crops are produced. The natural setting as well as proximate industrial and urban environments, present varying levels of risk to a fresh produce operation. Given the interaction and influence of diverse land uses on food safety, Western Growers believes that every effort should be made to ensure integrated programs that promote and protect these values and uses. Food safety programs should be developed in a manner that considers and minimizes impacts to ecological health, resource conservation measures and proximate industrial and urban land uses should be carefully calibrated to minimize any increase in risk of pathogenic contamination to fresh produce crops.


Varying levels of risk must be better understood and incorporated into food safety programs in order to ensure effective risk reduction and to avoid unnecessary costs and impacts. FDA should develop and clearly articulate criteria for evaluating risk as well as establish performance specifications to evaluate industry performance and progress. When clear risk criteria are established, FDA and industry can focus an allocation of effort and resources in areas of higher risk and on appropriate points in the whole supply chain, from ‘farm to fork,’ similar to Hazards Analysis and Critical Control Points (HACCP) process.

Risk Based

Producers report widespread concerns regarding multiple, conflicting criteria between various food safety programs and requirements. Food safety programs should work to harmonize with one another, as should auditing efforts. Western Growers believes that when FDA perfects and promulgates a mandatory federal food safety rule it should be developed in a way that fosters continual improvement without creating unnecessary and duplicative food safety programs. This could be accomplished by ensuring that FDA approve private food safety programs to ensure they meet and or exceed FDA standards and would allow for robust industry initiatives such as those in leafy greens and tomatoes. The recognition of these types of programs would help facilitate continual improvement while at the same time ensure that the FDA program is not the least rigorous - default food safety program with any number of private specifications stemming out of that baseline.

Harmonization of Requirements

Food safety programs should have high-quality complementary mandatory educational or certification programs targeted toward auditors and other program implementers, which aim to build consistency and accuracy in audit efforts and also help growers understand and comply with standards. To the extent practicable, all food safety programs should incorporate the availability of technical assistance to ensure that the full spectrum of operation types have an opportunity to equitably implement requirements tailored to their respective operations.

Education, Training and Technology

In addition to guiding tenets for the development of produce regulations, FDA has asked for specific feedback on several issues and has provided bulleted outline for organization of comments. Western Growers offers the following responses to those specific areas of inquiry by FDA recognizing that this is a preliminary effort and the beginning of a collaborative effort to shape responsible rules that protect public health and maintain agricultural vigor and viability.