FDA Investigation Report for Frozen Produce Facility at Center of Recall

The FDA released the inspection report of the CRF facility that was responsible for the massive frozen vegetable recall.  The inspection, conducted in March and transcribed below, found no blaring issues cited, but just some basic hits to the equipment and utensils used.  Surprising?  Not really, because a visual inspection is not going to identify low level contamination issues, such as what we expect was the case at CRF.   While you can find signs of sanitation lapses in an inspection that can lead to harborage issues or indicators of overall poor sanitation, it is really microbial sampling that will provide an idea of control.  Another important inspection is a review of the sampling being conducted by the facility - are they sampling for Listeria, how many samples, what are the results, is there corrective action, when are they sampling, who is doing the testing, how are they sampling, etc. In the end, is the facility really trying to find it, or are they doing testing just to say they are doing testing.

The transcription of the report:

Justice Department Investigates Salad Plant After Listeria Outbreak

 The US Justice Department is investigating the Dole with regard to the Salad / Listeria outbreak.  The question being raised is 'what did they know'?  This comes after an FDA inspection of the facility found Listeria monocytogenes.

The outcome of this investigation is important for processors who manufacturer products that can be affected by Listeria, especially those that had been regarded as lower risk (do not support appreciable growth).  Why?  Many manufacturers have Listeria Control Programs that have verification monitoring that focuses on Listeria species testing before production, or pre-operational, on non-food-contact environmental surfaces.  If found, then corrective action focuses on cleaning that area.

The concern is that this may not be aggressive enough.  We have now seen that Listeria can be an issue in product that supports minimal to no growth.  For one, we do not know how the consumer is going to handle products - perhaps using them as an ingredient in foods that better support growth, and in light of the Blue Bell outbreak, what minimal levels can cause illness in those at highest risk.  A more aggressive sampling would look at sampling during production and looking more at food contact surfaces.

Can you fault the plant?  Not based upon the current FDA Listeria Control Guidance.  What will it look like going further?

Wall Street Journal
http://www.wsj.com/articles/dole-food-under-investigation-over-listeria-outbreak-linked-to-salads-1461966955#:tqCQf4DgV4N9hA
Business
U.S. Probes Dole Food Over Listeria Outbreak Linked to Salads
Samples suggest Dole had evidence of bacteria at Ohio plant a year earlier

FDA Developing New Micro Surveillance Sampling Approach

FDA published notice of its sampling program.  "Under the new sampling approach, the FDA is collecting a statistically determined number of samples of targeted foods over a shorter period of time—12 to18 months—to ensure a statistically valid amount of data is available for decision making."  FDA has  been sampling since 2014, but looks to increase this surveillance, especially for items considered higher risk.

Companies should have a plan in place for the event product is sampled, whether that is in the market, or during an inspection.  If FDA samples product or the environment during an facility inspection, consider:
- Holding product.
- Stopping production and conducting a complete sanitation.
- Pulling duplicate samples and having them tested.
One of the difficulties is the delay that can occur with FDA getting back to a facility with results.  The longer the period, the more exposure in terms of extent of product distribution.

A proactive approach is always best - developing and implementing a sampling program to understand and control potential risks.

FDA Website - Sampling

http://www.fda.gov/Food/ComplianceEnforcement/Sampling/ucm20041972.htm

Sampling to Protect the Food Supply

The FDA Food Safety Modernization Act is based on preventing problems before they happen, rather than solely responding to outbreaks of foodborne illness. But in order to develop prevention-based systems, you need data and other information to help identify hazards that need to be addressed and minimized.

That is why sampling is an important part of this preventive approach and why the FDA is developing a new microbiological surveillance sampling model designed to identify patterns that may help predict and prevent future contamination by disease-causing bacteria.