FDA Issues Draft Guidance on Qualified Facilities within the Preventive Controls Rule

As part of the Preventive Controls Rule, FDA establishes 'Qualified Facilities' as those facilities exempt from having to establish HACCP based systems (Preventive Controls), but only having to comply with GMPs. But in order to become 'Qualified', they must submit a form to FDA attesting to their status as 'Qualified". This guidance provides detail on how to submit the required form, Form FDA 3942.

‘Qualified Facility’’ as defined by FSMA:
• Business with average annual sales of <$500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles); or.
• Very small business, which the rule defines as a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).

You can access that document here.

Kale Edamame Salad Recalled Due to Potential Salmonella Contamination in Kale

Trader Joe's is recalling Kale and Edamame Salad after the supplier of the kale notified the salad manufacturer, WCD Kitchens, that the kale may have Salmonella.

Retails such as Trader Joe's, who utilize a lot of small firms to provide their stores unique products seem to have more than their share of recalls.  This is certainly the challenge of working with firms that may have supplier issues of their own.

Another issue here is testing of product with short shelf-life.  By the time tests are taken and then confirmed, that product is already out in the market.


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm500286.htm
World Class Distribution Issues Voluntary Recall on Kale & Edamame Salad Due to Possible Health Risk
May 10, 2016

Contact
Consumers WCD Kitchen, LLC  (909) 574-4140 

Media Paul Mestas (909) 574-4140

Announcement
View Product Photos

WCD Kitchen, LLC of Fontana, California is voluntarily recalling Trader Joe’s Kale & Edamame Salad (UPC 00967112), sold only in the Midwest, with a “USE BY May 05, 2016 through May 14, 2016”, because the product may be contaminated withSalmonella. No illnesses have been reported to date.

Listeria Tracking and Whole Genome Sequencing - How Close is Close

As the CRF frozen produce recall has resulted in a cascade of recalls and millions of pounds of produce being pulled from shelves across the country, one can look at what triggered this - an Ohio Lab finding Listeria in frozen foods and an investigation of a frozen food plant that led to finding the organism in the plant.

According to CDC: Epidemiological and laboratory evidence available at this time indicates that frozen vegetables produced by CRF Frozen Foods of Pasco, Washington and sold under various brand names are one likely source of illnesses in this outbreak. This is a complex, ongoing investigation, and updates will be provided when more information is available.

Further in that report

Whole genome sequencing showed that the Listeria isolate from the frozen corn was closely related genetically to seven bacterial isolates from ill people, and the Listeria isolate from the frozen peas was closely related genetically to one isolate from an ill person. This close genetic relationship provides additional evidence that some people in this outbreak became ill from eating frozen vegetables produced by CRF Frozen Foods.

Whole genome sequencing has had a huge impact on outbreak investigations.  It allows investigators to match the organism involved in an outbreak back to the organisms found in the plant.  Using this output, one can look in time to past illness and do the same matching, what is termed retrospective analysis. But just because that organism is found in food or in the food plant, does that implicate that food? And how close is close when CDC says there is a close genetic relationship? We asked Dr. Edward Dudley of Penn State to provide some insight.

"A 5 base pair difference (or 5 SNPs) is strong evidence that the two are related. [Listeria has 3 million base pairs]  Even within an outbreak, it isn’t unusual for clones to vary by a few SNPs. This is one of the reasons the FDA is sequencing large collections of food borne pathogens including Listeria, in order to get a handle on how much genetic variation exists in natural populations. As we collect more of this data, it will tell us how quickly the DNA of these pathogens change in foods, food processing environments or during an outbreak, informing us how many SNPs should be allowed for us to still make strong case that two isolates are related."

"Keep in mind though, that genome sequencing should not be used by itself to make any conclusions. We still need the epidemiological (epi) data that provides a statistical link between the patient and an event, for example "did patients with Listeria eat frozen vegetables more commonly than healthy individuals during the time frame of the outbreak?”. The genome sequencing of isolates obtained from patient and foods is used to support the conclusions of the epi investigation when isolates from linked sources are found to be highly related on the DNA level."

So in the end, old fashion epidemiological evidence is still needed.   And there is still understanding is needed.  As for produce, many of the companies forced into a recall are doing so without knowing if there is actually Listeria in their product and in the absence of illnesses associated with their product.

Chipotle Retains Food Safety Gurus as Board Wants Ability to Pick Executive Board

Chipotle shareholders approved a proposal to give the chain's board approval to be able to nominate directors to the board.  At the same time, the chain acknowledge that it had hired two additional food safety experts.

Reuters
http://www.reuters.com/article/us-chipotle-shareholders-idUSKCN0Y2049
Business | Wed May 11, 2016 6:22pm EDT
Chipotle shareholders vote for more power to pick board
LOS ANGELES | By Lisa Baertlein

CRF Recall Triggers Recalls by Additional Processors and Retailers

A number of other packers of frozen foods issued recalls after an ingredient supplier, CRF issued a recall last week.  What started off as a massive recall continues to get bigger as product produced by CRF was repacked by other frozen food companies.

The list below in includes recalls from Stahlbush Island Farms, Harris Teeter, Twin Cities, Pictsweet, and NORPAC.

Walnuts Recalled Due to Listeria

A Woodstock, NJ company is recalling various Walnut products purchased from Gibson Farms after a sample of that product tested positive for Listeria monocytogenes.   This comes after another recall last week for sunflower seeds, although there does not appear to be any real connection.

Makes you wonder whether people will start testing the heck out of nut products for Listeria?  These products, because of low moisture / water activity, will not support the growth of Listieria.  And because they are produced in a dry environment, one would expect that environmental contamination would be minimal.  That being said, one would expect levels to be very low.

The biggest risk for these nuts would be if they were added as an ingredient to a product that supported growth.  And depending on the level, which would be expected to be very low, would only be a risk to those with a highly impaired immune system.

With two recalls, more research is needed to understand how Listeria is getting onto nuts, the levels present, and what real risk it poses.


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm500345.htm
United Natural Trading LLC Announces Voluntary Recall of Walnuts
For Immediate Release
May 10, 2016

Hoijicha Tea Recalled Due to Salmonella in Ingredient

Frontier Natural Product Co-op based in and a self proclaimed 'major supplier in the booming natural products industry', is recalling Organic Hojicha Tea due to potential to be contaminated with Salmonella. The recall indicates the recall was initiated after an ingredient tested positive for Salmonella. (While it seems the supplier did the testing, it is hard to determine from how the notice was written.)..

So what is Hojicha tea? Good question.  Well, Hojicha tea is a roasted tea that is more mild and has less caffeine. The roasting process makes the tea leaves reddish in color and gives the tea a ' a toasty, slightly caramel-like flavor'. Because of the lower caffeine level, it is often served with dinner.

So how would Salmonella get in the Hojicha?  Another good question.  If the tea supplier was responsible, and being the leaves were roasted, it would have to be a case of cross contamination in the post-roasting environment.


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm500342.htm

Frontier Co-op Initiates Voluntary Recall of Organic Hojicha Tea Due to Possible Health Risk

CRF Vegetables Leads to Recall of Fried Rice Product Which Leads to Recall of Chicken Fried Rice Product

In a series of recalls following the CRF vegetable recall - Ajinomoto Windsor, Inc recalled its fried rice products because they had CRF as a supplier of the vegetables used in the rice mixes.  This then triggered Garland Ventures LTD, a Garland, Texas establishment to recall 114,870 pounds of chicken fried rice products.  Both items are considered not ready-to-eat.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm499858.htm
Ajinomoto Windsor Recall of Products Related to CRF Frozen Vegetable Recall
For Immediate Release
May 7, 2016

Sunflower Seed Recall Forces a Large Cascade of Recalls

After SunOptima issued a recall for Listeria in sunflower seed, a number of their customers issued recalls.  Probably more to come?

One this that would be good to know is how the sampling / testing occurred after product had shipped and was utilized by their customers.

Recalls listed below: