July 31, 2009
- Why is FDA adopting industry guidance? Isn’t this unusual?
- If FDA already has GAPs guidance, why are commodity-specific guidances needed?
- Why didn’t FDA start work on commodity specific guidances when the broadscope guidance was finalized years ago?
- Why is FDA issuing industry guidance only for tomatoes, melons and leafy greens?
- Can the Commodity-Specific Guidelines (CSGs) be applied to other commodity groups?
- What commodity-specific recommendations have been developed by industry?
- Will these guidances change as industry practices change?
- Why take the industry guidance and adopt as FDA guidance?
- Is FDA planning to issue other industry guidance this calendar year?
Q: Why is FDA adopting industry guidance? Isn’t this unusual?
FDA looks at all available information to inform us in our activities. When FDA developed the 1998 Good Agricultural Practices (GAPs) guidance, we looked at available but limited information including other GAPs recommendations developed by industry as well as university and regional commodity associations. (We also looked at industry guidance in developing our Fresh-cut guidance, which was finalized in 2008.)
When the 1998 GAPs guidance was finalized, other public and private groups, including the National GAPs Program (“Food Safety Begins on the Farm – a Growers Guide” in 2000) and Codex Alimentarius (international) used FDA’s guidance as a basis for their efforts.
Q: If FDA already has GAPs guidance, why are commodity-specific guidances needed?
We wrote the GAPs guide in 1998, and have since then worked in collaboration with USDA and in cooperation with industry to implement it; it was intentionally very broad, providing recommendations for the production and packing of all fresh fruits and vegetables consumed in the U.S., whether they are produced domestically or abroad. We recognized in the Guide that to be most effective, the recommendations would need to be tailored to individual operations. Based on the experience over the past decade from industry practices in implementing the Guide and other produce safety measures, we have developed these more specific, additional guidance.
Q: Why didn’t FDA start work on commodity specific guidances when the broadscope guidance was finalized years ago?
In 1998, microbial food safety on the farm was a relatively new idea. A few groups, including commodity associations, had proactively developed their own guidance. However, it wasn’t until several years later that the current pattern of “priority commodities” (see below) began to emerge. FDA did develop and release guidance for sprouted seeds in 1999, and also began work on guidance for fresh-cut produce.
Q: Why is FDA issuing industry guidance only for tomatoes, melons and leafy greens?
At a produce summit in January of 2004 (Hosted by United Fresh), industry leaders agreed to the need for commodity specific guidance and in June, 2004 established workgroups to develop guidance for best practices along the supply chain for a number of priority commodity groups, including: melons, lettuce and leafy greens, tomatoes, and green onions and herbs. FDA has provided technical assistance to these efforts.
Q: Can the Commodity-Specific Guidelines (CSGs) be applied to other commodity groups?
Yes. While these documents were developed to address specific target audiences, many of the concepts discussed have broad application to all commodities. The concepts include environmental assessments, worker health and hygiene, water quality, product tracing, and records.
Q: What commodity-specific recommendations have been developed by industry?
So far, Industry led, commodity specific, supply chain guides have been developed by a broad coalition, including industry representatives along the supply chain, universities, and state and federal agencies for
Numerous additional guidances (e.g., strawberry, watermelons and mushroom) have also been developed by commodity associations.
- lettuce & leafy greens,
- green onions (currently under development)
Q: Will these guidances change as industry practices change?
The industry guidances are being issued in draft form; they will be issued in final version in response to comments and new data received. In addition, like all Agency guidances, these are always subject to further comment and to review and revision based on new information or changes in industry practices.
Q: Why take the industry guidance and adopt as FDA guidance?
FDA provided technical assistance in the development of various industry guidance and has posted links to this guidance on our web site to broaden awareness. In developing the commodity-specific guidances, the FDA started with the industry guidance and incorporated lessons learned by the Agency since 1998 and those reflected in 2005 commodity-specific guidances developed by the product industry. As with the fresh-cut guide, however, we believe that taking existing industry (or other) guidance and adopting all or part of the guidance as FDA guidance may lend additional credibility to the recommendations in the guidance and further promote its implementation. For example, the marketplace can exert significant pressure of practices followed by suppliers. Buyers may be further encouraged to incorporate these recommendations in their purchase requirements if the recommendations come from FDA.
In addition, the CSGs complement FDA’s Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (GAPs Guide) and provide a framework for identifying and implementing appropriate measures to minimize the risk of microbial contamination at all points along the supply chain for melons, leafy greens, and tomatoes. The recommendations in the commodity-specific guidances reflect advances in knowledge in many of the broader issue areas set out in GAPs guide could also be adopted by other commodity groups as appropriate.
Q: Is FDA planning to issue other industry guidance this calendar year?
FDA expects to publish its draft (product) tracing guidance on or before October 7, 2009. The guidance will be open for comment for at least 60 days. When finalized, FDA anticipates that the guidance will offer comprehensive recommendations on product tracing, including the importance of linking tracing records throughout the supply chain.