The deadline for providing input to the FDA on the agency's draft guidance for tomatoes, melons and leafy greens was Jan. 4. I'll use the Fresh Talk space to post some excerpts of comments to the FDA about the draft guidance. First, let's look at Food & Water Watch, a consumer group that is sympathetic to the small, diverse grower.  In their comments, they urge the FDA to reconsider its "commodity specific" approach and instead look at "whole farm" food safety.

Find the entire FDA docket here, and below are highlights from the Food & Water  letter about the tomato guidance:

January 4, 2010

Food & Water Watch is a national nonprofit consumer advocacy organization. We appreciate the opportunity to comment on “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes; Draft Guidance,”(Docket # FDA-2009-D-0346), hereafter referred to as “the draft guidance on tomatoes.”

Small and midsized farms serve important local and regional markets, including schools and other institutions, restaurants, and grocery stores. Many also operate community supported agriculture (CSA) programs and/or sell at farmers markets or farmstands. These farms may grow as many as forty or fifty different crops and also raise livestock.

For these farms, commodity-specific guidance may be inappropriate. At the very least, it will be difficult for them to implement it if the guidance for certain crops conflicts with the guidance provided for others. For example, as currently written, the draft guidance for tomatoes puts an emphasis on the risks associated with runoff from animal operations, while the guidance for leafy greens emphasizes the risk of wild animal intrusion. If producers are growing both leafy greens and tomatoes, as is common among small and midsized diversified farms, they will struggle to prioritize their actions in response to the guidance. Should they install a vegetative buffer to stop runoff from cows on their neighbor’s farm, or mow down vegetative buffers because they could harbor mice or birds?

We urge the Food and Drug Administration not to go down the path of dealing with on-farm food safety by issuing distinct guidance for individual commodities. Such a commodity specific approach misses the opportunity for a whole-farm approach to food safety and is unworkable for diversified farms that grow many different crops and will be unable to navigate different guidance for each one.

We urge the agency to create whole-farm strategies for food safety and to provide guidance for specific activities that are known to be high risk, either due to the type of production, processing, or supply chain.

If the agency continues to pursue commodity-specific guidance, we offer the following recommendations on the draft guidance for tomatoes. Recommendation: The draft guidance for tomatoes should specifically acknowledge that many farms grow multiple crops and that commodity-specific guidelines may not be appropriate for such farms. These farms can be directed to the GAPs or other general produce guidance provided by the FDA.

Recommendation: The FDA should ensure as much consistency as possible between the commodity-specific guidelines so that producers who do choose to use them are not overwhelmed by mixed messages

Farms selling direct to consumers, farms that do not co-mingle or process their products, and farms whose products are identity-preserved With respect to both risk and traceability, the type of supply chain into which tomatoes are sold has a significant impact and should be considered in the guidance.

In addition, products that are direct-marketed or whose identity is preserved from the farm to the consumer are inherently more traceable than products that are co-mingled. Uniform traceability requirements are both burdensome and unnecessary for participants in shorter supply chains and would not result in material improvements to food safety.

Recommendation: Preserve the language in paragraphs 2 and 3 of Section XI, Freshcut/Value-added Processing, which identifies some of the relative risks associated with freshcut tomatoes and the processing of large volumes of co-mingled product.

Recommendation: Products that are direct-marketed or whose identity is preserved from the farm to the consumer should be uniquely addressed. Guidance on traceability should acknowledge these differences and note that traceability systems beyond one-step-forward, one-step-back are more relevant and necessary for products being sold into long supply chains.

Recommendation: The FDA should coordinate with the USDA’s National Organic Program to ensure that traceability guidelines are not duplicative or overly burdensome to organic producers.

Recommendation: The FDA should include in the comments considered for the tomato draft guidance the transcript from the USDA’s public hearings on the proposed National Leafy Green Marketing Agreement.

Although the topic of the hearings was not tomatoes, the seven hearings held across the country in September and October 2009 offered a wealth of evidence about the different approaches to food safety used across the country and the impact that one size-fits-all private food safety programs have had on many smaller players in the industry. These lessons are applicable to tomato producers as well.

Recommendation: Provide animal-specific, region-specific guidance on wildlife, including an assessment of the likelihood that an animal will present a microbial contamination risk, so that producers can make informed management decisions.

Recommendation: Retain the language in Section 1, Environmental Assessments and Risk Reduction Practices, that highlights the risk posed by runoff or drainage from animal operations, and provide additional guidance to producers on mitigating the impacts from these operations.

Cattle, especially in feedlot operations that concentrate large amounts of waste, present a significant risk to food safety if runoff or drainage enters the production area for fresh produce. Cattle are by far the most common and prevalent source of E. coli 0157:H7 in the environment. Some research suggests that cattle fed grain are more likely to shed E. coli 0157:H7 in their feces than cattle fed on pasture.

Clear guidance encouraging practices that benefit food safety and are common to organic, diversified, and conservation-oriented farms will facilitate widespread adoption of food safety measures. It will also ensure consistency among federal farm programs, result in more efficient use of taxpayer dollars, and reduce confusion for producers and consumers.

 Finally,it will help reduce the incidence of “super metrics” promoted by produce buyers and auditing firms that interpret FDA guidance in extreme ways. We run the risk of overriding twenty  years of successful on-farm conservation and resource management efforts if federal guidance does not move in this direction—and we may also jeopardize food safety in the process.

Recommendation: The draft guidance on tomatoes should explicitly encourage and provide examples of conservation practices known to benefit food safety. These could include windbreaks and vegetative buffers around waterways, between manure storage areas and crop fields, and between livestock and crop fields to manage dust and filter runoff.

Recommendation: The draft guidance on tomatoes should explicitly discourage practices known to be counterproductive to food safety and resource conservation, such as blanket habitat destruction or the maintenance of bare-ground buffers around production fields.

Recommendation: Ensure that the draft guidance on tomatoes is consistent with conservation and environmental practice standards established by other federal agencies and with certified organic production methods and requirements. FDA should coordinate with relevant agencies to ensure that standards and programs are not in conflict.

Recommendation: The draft guidance for tomatoes should explicitly acknowledge that records may be kept electronically or on paper. FDA should pay special attention to recordkeeping requirements that are already in place and recommend ways to make recordkeeping compatible with these existing systems, including organic certification.


As the FDA develops its on-farm food safety guidance, we urge the agency not to proceed in a vacuum. Work on the issue of food safety is underway in several other venues, including Congress and the USDA, and we urge FDA to consider these policy arenas, as well as industry-driven food safety programs, as you proceed. It is burdensome for farms to have to track the results of multiple policy processes as well as private programs required by their buyers.

Additionally, we urge the agency to develop any guidance or regulation in a way that does not put organic, diversified, conservation-oriented, or small-scale farms at a disadvantage. To do so, regulations or guidance must have some flexibility, not discourage or penalize efforts to practices, and not promote a sterilization model of farming.

Finally, we urge the agency to re-evaluate its research agenda and prioritize research that will shed more light on the risk of various species of wildlife as a vector for transmission of pathogens to the food supply, the impact different processing techniques have on contamination rates, and the use of alternative methods such as vegetative buffers for pathogen control. Food & Water Watch appreciates the opportunity to comment on the FDA’s draft guidance on tomatoes. Please contact Patty Lovera at (202) 683-2500 if you have questions or need more

Wenonah Hauter