FDA’s new rules on produce safety

I’ll say this again.  No, Cyclospora is not a food industry conspiracy to keep people from eating real foods.  It is a serious illness that has put plenty of people in hospitals and killed at least two.

At Monday’s MAHA press conference (see yesterday’s post), the FDA announced:

Finally, though not part of today’s announcement, with respect to microbiological food safety, FDA will be publishing tomorrow a final guidance document titled “Guide to Minimize Biological Hazards in ready-to-eat fresh-cut produce.” This final guidance is intended to help manufacturers and processors of fresh-cut produce comply with applicable FDA requirements and 21 CFR Part 117 titles current good manufacturing practices, hazard analysis, and risk-based prevention controls for human food.

The announcement: Guidance: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce

The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

The announcement says the new guidance will:

• Update, correct, and clarify the FDA’s 2018 Guide to Minimize Food Safety Hazards of Fresh-Cut Produce
• Clarify that the guidance applies only to ready-to-eat fresh-cut produce with a water activity above 0.85 (a water content high enough to support microbial growth)
• Add another example of an antimicrobial substance that can be used as a process control in the production of fresh-cut produce
• Provide additional examples of a supply chain program to control pathogens in a fresh-cut processing facility
• Provide additional recommendations on time/temperature controls

The new guidance: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce: Guidance for Industry

These are nonbinding recommendations.

They are aimed at processors and manufacturers, not growers.

They deal with contaminants on produce entering the processing plants and with those that might occur during processing, as a result of:

• Unclean water supply
• Poor worker hygiene
• Inadequate plumbing and sewage disposal
• Inadequate hand washing
• Inadequate product washing

They also cover such matters as supplier verification: conducting hazard analyses, onsite audits, sampling, and testing.

Comment

What they do not do is say anything about irrigation water, the most likely cause of the Cyclospora outbreak.

Here is Bill Marler on the FDA’s recent history of inadequate attention to irrigation water.

Pre-harvest agricultural water is the clearest case of an element written and then withdrawn. The 2015 rule set a geometric mean of no more than 126 colony-forming units of generic E. coli per 100 mL and required growers to test against it. The compliance dates were pushed back, enforcement discretion was announced before the first of them arrived, and in May 2024 the criterion and the testing requirement were replaced outright by an annual assessment in which the grower evaluates his own water and decides for himself what to do about it. I walked through that record this week in connection with the jalapeños out of Sinaloa. Nine years, three delays and a repeal, and not one farm ever had to hit the number.

Let’s hope the FDA gets on this.

It also needs to do a whole lot more than nonbinding guidance.

The FDA needs the authority to require companies to produce food safely, and hold them accountable if they do not.

If it does not have this authority, it needs to get Congress to authorize it.

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