If you process tahini, you should include Salmonella as a known or reasonably foreseeable hazard

After a few months of retreating and thinking about next steps for barfblog, and focusing on consumer food safety observations in our new kitchens, I’m getting back in the posting mix.

And still, one of my favorite emails (after the weekly MMWR notification) is FDA’s updated warning letters. There’s so much to be learned in these beyond the fun stuff like peeling the skin off of a bearded dragon (not a euphemism).

Here’s my favorite from today’s update, courtesy of Sunshine International Foods Inc – a tahini processor.

There are a few nuggets in this one but my big takeaway is that the letter provides a fantastic blueprint for all other tahini processors to follow if they want to meet what FDA expects. Including that you absolutely need to include Salmonella as a known or reasonably foreseeable hazard in a preventive control plan.

Oh and if you are a retailer or food service buyer, looking through these warning letter alerts are probably a good idea – I’d be making vendor decisions based on these (and asking my current suppliers how they are different from the folks who receive them).

From the letter:

Your hazard analysis did not identify a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a)(1). The hazard evaluation must include an evaluation of environmental pathogens whenever a ready-to-eat (RTE) food is exposed to the environment, as required by 21 CFR 117.130(c)(1)(ii). Your RTE tahini products made from natural sesame seeds are exposed to the processing environment following pasteurization and prior to packaging, and your repackaged RTE tahini products are exposed to the processing environment throughout the processing of these products. Although you have identified “Microbial Growth Staphylococcus Aureus” as a potential significant food safety hazard in your hazard analyses for your RTE tahini products (including RTE tahini manufactured from natural sesame seeds with creation date 5-01-18, RTE flavored tahini manufactured from natural sesame seeds with creation date 5-01-18, repackaged RTE tahini with creation date 5-01-18, and RTE flavored tahini using raw tahini received at your facility with revision date 3-6-19), these hazard analyses do not identify contamination of RTE tahini with the environmental pathogen of Salmonella as a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at your facility to determine whether it is a hazard requiring a preventive control.

Also, folks should do better on cleaning and sanitizing the hard to get spots where Salmonella or Listeria might be living.

1. All food-contact surfaces, including utensils and food-contact surfaces of equipment, must be cleaned as frequently as necessary to protect again contamination of food, as required by 21 CFR 117.35(d). However, our investigators observed the following conditions:

a. Hardened tahini was present around the gasket between a stainless-steel pipe feeding from the hold/pasteurizer tank to the hopper for the retail jar filler located in the Pasteurizer/Filling/Packing Room.

b. Soft tahini was observed around and beneath the lid seams to the retail line filler hopper in the Pasteurizer/Filling/Packing Room.

c. Soft and hardened tahini were observed inside the retail line filler hopper and (b)(4) filler heads.

d. Soft tahini was observed inside the square mixer and grinding/milling hopper in the Roasting/Milling Room.

e. Chocolate tahini was observed inside the stainless-steel pipe feeding into the (b)(4) in the Pasteurizer/Filling/Packing Room.

Repeat violations is a pretty good indicator of a food safety culture issue

My kids are terrible at remembering things. Everyday one of them forgets at least one of the following: homework; water bottle; to change his socks; to flush; brush their teeth.

There are many more.

As a parent it’s my job to keep reminding them – and it gets frustrating when the same things are done over and over.

But they are 8 and 10. And not running a food business. Their repeated mistakes don’t leave to foodborne illness risks for thousands of customers.

I read the FDA warning letters with fascination every time an email alert comes out. Today’s  highlight for me was that a food business, Reuben’s, cant seem to get stuff straight after repeated reminders from FDA inspectors. In 2005, 2008, 2009, 2016 and again last fall they had issues with facilities, pests and behaviors.

The investigators found the same stuff. That’s frustrating – and kinda shows that the business leadership doesn’t get it, or care.

When someone asks me about inspection results at a restaurant or a processor I tell them the limitations of the snapshot, what really matters is how has the business dealt with issues over time. Repeated issues without fixing shows a negative food safety culture in my books.

Here are some other highlights:

Several tiles were missing on the production floor. Water was pooling on the floor where tiles were missing/broken.

Chiles fell onto the dirty floor and were picked up by and placed into the rinse/cooling tank with other roasted chiles

Uncovered chile relleno products were observed in the walk-in freezer. The ceiling directly above the uncovered products displayed an accumulation of condensation drops and peeling paint.

We observed an employee push an uncovered rack of green chile from the walk-in refrigerator into the production area. The sides and top layer of green chile came in direct contact with an curtain which appeared to be soiled with red chile debris and grime.

I do love a good warning letter; here’s the Honey Smacks one

I love the FDA’s ongoing release of warning letters. This practice gives an insight into what’s happening in food facilities, especially important are the ones that are linked to outbreaks. FDA warning letters and 483 inspection forms have brought gold like us tugging at the dried skin of bearded dragons as well as scratching intergluteal clefts.

As the great Stefon says, the Kerry Inc./Honey Smacks warning letter has everything – pathogens, incomplete hazard analyses and poor sanitation. 

Some highlights:

Your hazard analysis did not identify a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control as required by 21 CFR 117.130(a)(1).

Between September 29, 2016 and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms. During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples (samples taken in response to finding a positive on routine testing),

Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal. These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan as required by 21 CFR § 117.170(b)(4) and the identification of contamination of RTE cereal with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation preventive control).

Washington company linked to Listeria monocytogenes illnesses gets a warning letter

Like my RSS feed notification for MMWR, FDA’s warning letter email alerts get me all excited about the potential treasures within. Like bearded dragons. And Whole Foods condensate issues.

Most telling are the letters that come after an outbreak investigation and that state almost 18% of environmental samples tested positive for Listeria monocytigenes (whoa).

FDA posted a warning letter to the Oregon Potato Company, AKA Freeze Pack, which was connected to CRF Frozen Foods outbreak.

FDA’s laboratory analysis of environmental samples collected on March 8, 2016, and March 9, 2016, confirmed that nineteen (19) of one hundred and six (106) environmental swabs tested positive for L. monocytogenes.Oregon_potato_Company

Specifically:

– Seven (7) positive environmental swabs were collected from direct food contact surfaces in both your Processing and Packaging Rooms during the production of your IQF diced onions. These direct food contact surface areas include:

o The chiller water and the interior north wall of the water chiller. Water from this chiller is not treated and is recirculated back to the blancher/chiller and used directly on blanched diced onions as a coolant;

o A white nylon strip in the tunnel discharge chute between the IQF freezer and the finished product Packaging Room. Blanched, finished product is conveyed and comes into direct contact with the nylon strip; and

o The metal arm on your chain conveyor belt between the IQF freezer and Packaging Room where blanched, finished product is conveyed directly on this conveying system and comes into contact with the metal arm.

– The remaining twelve (12) positive environmental swabs were collected from locations in your Processing room and your Packaging Room that were in areas adjacent to food contact surfaces and non-direct food contact surfaces.

WGS analysis was conducted on the nineteen (19) L. monocytogenes isolates obtained from the FDA environmental samples collected on March 8, 2016, and March 9, 2016. The WGS phylogenetic analysis establishes that there are at least two (2) different strains of L. monocytogenes present in the facility, with one strain containing seventeen (17) isolates and the second strain containing two (2) isolates. Specifically, the WGS analysis of the strain with 17 isolates showed that the isolates are identical to each other. WGS analysis of the strain with 2 isolates showed that the isolates are identical to 8 cases of human illness dating back to 2013, and to 6 isolates from finished products. These finished products included onions (2 isolates in 2014) and green beans (3 isolates in 2015) tested by a third party laboratory, and a single isolate from white sweet corn collected and tested by the state of Ohio in 2016. Additional investigation established that at least six (6) individuals were hospitalized as a result of related L. monocytogenes associated illness.

There’s a lot of cGMP Violations noted as well including cleaning and sanitizing issues, condensation dripping over IQF production lines and lots of niches for Listeria.