Here is an excerpt of a submission by Western Growers on the FDA’s docket on its draft guidance for leafy greens. WG asks for FDA to better define “terms of art” such as “consider” and “evaluate.” Asking for clarity from regulators is a tall order….


Go here for the federal docket.

January 4, 2010

Western Growers, a non-profit trade association representing growers and handlers of fresh fruits nuts and vegetables from California and Arizona, appreciates the opportunity to comment on FDA’s draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens (“Guidance”).

 We applaud FDA’s publishing of this Guidance as means of communicating FDA’s current thinking and recommendations regarding the safe production, harvesting and post-harvest handling of fresh and fresh-cut leafy greens.

We recognize that many of the specific recommendations contained in the “Guidance” have been taken directly or adapted from the industry’s 2006 “Commodity Specific Food Safety Guidelines for the Lettuce and Leafy Greens Supply Chain" and appreciate FDA’s recognition of the leafy green industry’s proactive work in the area of food safety including the development and implementation of more specific, measurable and verifiable “metrics” developed in late 2006 and 2007 and accepted for use in conjunction with marketing agreements in both California and Arizona.

 Western Growers has been fundamentally engaged in the leadership and development of these industry documents as well as collaborating with FDA on both domestic and international model codes. Western Growers largely agrees with the recommendations in this draft Guidance, but also believes that as this document is finalized and becomes a platform for potential regulation there are many improvements that can be made to ensure its clarity, utility and accessibility to the industry as well as definitively articulate FDA intentions and expectations to the leafy greens industry and to all interested parties both inside and beyond the United States. We offer our comments in the spirit of improving this Guidance and as part of our continuing commitment to collaborate and cooperate with FDA to improve food safety in the fresh produce industry.

 General Comments Western Growers encourages FDA to work towards consistency of structure and language between varying guidance documents. We believe it makes sense and would be of value to the industry to develop and maintain recommendations that should be common throughout commodities as well as the supply chain. As an example of this we raise the topic of water.

 Water is recognized by the industry and the agency alike as a potential risk in fresh produce operations. We would recommend that water be addressed in every guidance document as a stand-alone section. In this discrete section, recommendations for the use of water during irrigation, harvest or post-harvest operations would remain consistent with the exception of any unique (commodity specific) uses that may need to be treated differently.

In simplest terms the recommendations would ensure that the source and quality of water was known and its use at different points from production through distribution to end users would not increase the risk of contamination.

These common areas might also include consistent language on hygiene and sanitation as well as documentation and records. Western Growers also encourages FDA to provide consistent and clear expectations for several terms of art utilized throughout the FDA guidance for industry including terms such as “consider” and “evaluate”. These terms often utilized as the actionable part of FDA recommendations are, without further definition, vague and open to broad interpretation.

 Is it, for example, sufficient to “consider” or “evaluate” options for control or mitigation of a risk without corresponding action? Is it appropriate to document the risk and rationale for implementing one control over another? What factors need to be “considered” or “evaluated” during this process? Does it include the level or severity of risk, the efficacy of potential control(s) the economic factors associated with varying controls?

These questions are among the list of issues that Western Growers believes must be taken into account when “considering” or “evaluating” risks and control strategies. It would be important for FDA to develop a non-exhaustive list of factors that one might utilize when conducting recommendations to “consider” or “evaluate” including whether or not there is an expectation for these factors and conclusions to be documented at different operations within the leafy greens supply chain.

 Documentation and Records

Western growers comments on Documentation and Records sections contained in this guidance are general and consistent in nature so we offer them up front in our general comments section and encourage FDA to consider our comments for all sections of this and other guidance dealing with records and documentation. In these subsections FDA cites the Code of Federal Regulations and refers readers to separate documents to identify specific records required by law.

Western Growers recommends as a matter of practice that FDA strive to enumerate these requirements in the Leafy Green Guidance as a means of creating a comprehensive set of recommendations in a single source.

It enhances the usability of the guidance if readers do not have to search out other documents to understand additional recommendations or requirements. In addition, since this guidance document is intended as a non-binding series of recommendations from FDA we question the need for the notes that spell out exemptions from recordkeeping requirements. Do these notes for example mean FDA does not encourage (recommend) farms keep records?

 FDA should clearly encourage good recordkeeping at all levels of the supply chain and while subsequent sections on “operational records” include FDA recommendations that appear to do that – highlighting that farms or other operations within the supply chain are exempt seems to run counter to the recommendations.

Product Tracing

Western Growers understands and appreciates that FDA and USDA are working to develop regulations for product tracing and we intend to provide additional input in this area. The second bullet calling for “standardized” records will be problematic until such time as specifications are itemized for industry.

In this guidance however Western Growers would encourage FDA to distill and include as recommendations those elements of the “Guide to Traceback Investigations” that FDA believes are critical for leafy green operations rather than again referring readers to a separate document and expecting them to discern what FDA would recommend.