FDA: More questions than answers

The FDA has set the dates for the widely anticipated food safety hearings, and that info and more is found in this link. The first meeting is in Oakland on March 20 and the second in Maryland on April 13. The industry's call for strong federal oversight will be explained in these hearings.

Bring your three ring binder. The FDA wants a lot of input. Here are their questions:

For each stage in the supply chain, and for each industry sector, what are the risks or practices that could lead to microbial contamination of fresh produce?

How can or should current practices be changed to reduce the risk of contamination?

For each stage in the supply chain, and for each industry sector, what current practices (including, for example, following the GAPs/GMPs Guide) reduce the risk of microbial contamination of fresh produce? What data are available to support a conclusion that the risk of such contamination is lower than it would be without the practice in place?

Is fresh produce, or inputs such as agricultural water, sampled and tested for pathogens or indicator organisms at any stage of the supply chain? If yes, please describe the sampling and testing done.
Beyond the Federal actions described in sections I.B. through I.E, what new Federal actions, if any, are needed to enhance the safety of fresh produce? On what aspects of the produce supply chain should the measures focus?

In identifying possible Federal interventions or actions, to what extent can or should we take into account the wide variation within the fresh produce industry with respect to, e.g., the size and type of establishments, the nature of the commodity produced, the practices used in production, and the vulnerability of particular commodities to contamination?

To what extent should such measures apply to specific products, sectors of the industry, regions, or businesses?

For example, is there a need for special treatment for different commodity groups?

What types of records and other information, from what types of facilities, are or would be most useful in facilitating traceback efforts?


Are written food safety plans, written SSOPs, periodic assessments, training, and/or the establishment and maintenance of records useful for risk identification and risk mitigation or management purposes?
If yes, to what extent are these practices in place, and in what sectors of the industry?

How should adherence to the GAPs/GMPs Guide or new produce safety guidance(s) be measured and verified by the grower or operator, government regulators, or third-party auditors, in the event of any new recommended Federal action or in the event you are not recommending any new Federal action?

If you are recommending any new Federal measures, please describe how they might affect certain small businesses, such as roadside stands, farm gate operations, farmers’ markets, or other small businesses involved in direct sales.



TK: As we anticipate these important meetings, is it too much to ask the FDA to provide more answers to the industry and the public about what farming practices led to E. coli contamination of spinach and lettuce in recent foodborne illness outbreaks?