FDA To Hold Hearings
On Safety Of Fresh Produce

The FDA has issued an announcement:

FDA TO HOLD PUBLIC HEARINGS ON THE SAFETY OF FRESH PRODUCE

The Food and Drug Administration will convene two public hearings to share information about recent outbreaks of foodborne illness associated with microbial contamination of fresh produce, and to solicit comments, data, and other scientific information about current agricultural and manufacturing practices used to produce, harvest, pack, cool, process, and transport fresh produce. FDA is also seeking information and comments on risk factors for contamination of fresh produce associated with these practices; and on measures by FDA that could enhance the safety of fresh produce.

According to the FDA announcement, the public meetings will address the following issues and questions:

1. 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?
2. How can or should current practices be changed to reduce the risk of contamination?
3. 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?
4. 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.
5. 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?
6. 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?
7. What types of records and other information, from what types of facilities, are, or would be, most useful in facilitating traceback efforts?
8. 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?
9. 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?
10. 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.

The FDA has been saying it would do this for some time and probably was waiting to see the California Leafy Greens Marketing Agreement come into effect.

The implications of these hearings are vast. They are asking the kind of objective questions that need to be addressed. For example, we are all busy drawing up new Good Agricultural Practices documents, and the FDA has the temerity to ask: 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?

A good objective look at all our efforts may be bracing. In addition, if United’s call for Federal regulation is going to be heeded, these hearings will provide important evidence to support that call. Note that Point 5 asks specifically “…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?”

You can get full details on the hearings, including how to register and how to submit comments, right here.