The FDA has published guidance with information for manufacturers and processors of ready-to-eat produce to help them comply with federal law.
The guidance is non-binding and does not carry the force of regulation or law and therefore can only been seen as informal recommendations for industry.
“FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidance means that something is suggested or recommended but not specifically required,” according to the 80-page guidance document.
Kyle Diamantas, the acting Commissioner of the Food and Drug Administration, touted the guidance and said Americans should feel confident eating fresh produce, leafy greens included. His comments come amid the country’s largest ever foodborne illness outbreak in which more than 28,000 people have been infected by the Cyclospora parasite.
The guidance, which has been several years in the making, does not specifically discuss the current outbreak but it does reference Cyclospora.
“. . . we are not currently aware of any antimicrobial that would significantly minimize or prevent Cyclospora cross-contamination and be suitable for use on fresh-cut produce. While your goal should be that your wash water antimicrobial be effective against all pathogens that you have identified in your hazard analysis as requiring a preventive control, we recognize that validating such control at this time for all pathogens could be beyond the scope of current science,” the guidance states.
The suggestions for the fresh produce industry in the guidance document were designed to help producers comply with Current Good Manufacturing Practice, Hazards Analysis, and Risk-Based Preventive Controls for Human Food rule under the Food Safety Modernization Act, which was signed into law Jan. 4, 2011.
Examples of fresh-cut produce discussed in the guidance include chopped lettuce, cut cantaloupe, diced onions and apples. For example, the guidance addresses the documents businesses should ask for from suppliers that show produce is subject to specific laws. However, the guidance does not suggest that the processors ask for documentation that the produce suppliers have met the requirements of those laws.
“Before first receiving apples from the supplier, the PCQI obtains written assurance that the apples are not subject to the PSR in accordance with §112.4(a), or in accordance with §§ 112.4(b) and 112.5, and that the farm acknowledges that its apples are subject to section 402 of the FD&C Act (21 CFR 117.410(d)(2)(ii)),” the guidance states.
Specific points addressed by the guidance include:
- Handwashing
- Employees eating, chewing gum, drinking or using tobacco products while working
- Removing trash
- Closing doors
- Washing equipment
An example of the guidance suggestions is that companies record the actual measured temperature of produce, such as “37°F” rather than simply stating whether the measured temperature was within the acceptable operating range.
Additionally, the guidance suggests that using the weakest antimicrobial solution for least amount of time will be least efficient in eliminating pathogens.
