FDA Warning Letters This Week 3/1/17

warning-letters

The week goes by and new letters come out. Looks like we’ve only got one food letter this week so let’s get into it.

Don’t know what warning letters are? Check out this post for a brief overview of what they are and why FDA sends them out.

WL# CMS Case 517876 (man, they really aren’t consistent with this numbering system, are they?)

Subject: Seafood HACCP/CGMP for foods/adulterated/insanitary conditions

Our first finding here is once again a failure to follow the seafood HACCP requirements. As we’ve discussed on this blog before, companies that produce Juice and Seafood have specific critical control points and HACCP plans spelled out in the regulations. Oftentimes small companies or importers who have never been inspected, or were never aware of what their requirements were, violate or do not put these programs in place. Because this is considered an imminent threat to food safety, FDA almost always issues a warning letter. Most of what you see are companies that just straight up don’t have the programs in place, rather than specific violations.

This particular firm falls into this category, and we’ll see from the responses they already provided to FDA in this warning letter that they clearly don’t have someone on staff familiar with the regulations required of them, or a genuine appreciation for the ones that actively protect food safety. FDA noted that the HACCP finding is based on the fact that the company simply didn’t have one for the product. It’s possible that because the name of the company doesn’t imply that it manufactures a lot of seafood (check the warning letter to see what I mean), they may have started making this ingredient recently before fully understanding what was required of them. This doesn’t change the fact that the firm demonstrated poor understanding of certain food safety and regulatory requirements in general. For example, in response to not having the HACCP plan, they told FDA that they would look into it in response.

FDA said ‘lol, no’, you can’t just keep making food outside of a critical food safety regulation until you decide to get around to it.

In your letter, you agree that your firm has no HACCP plan in place.  You included a statement that you will seek “further information regarding obtaining this HACCP plan” for your firm; however, your response is not adequate. You did not provide a timeframe of when a HACCP plan will be established and implemented, and your response does not provide assurances that your firm will process this product under an adequate HACCP plan.

finger-quotes
This “HACCP Plan”

We’ll look into this “HACCP plan” thingy, whatever it may be, is not an adequate response. The firm violated a spelled out regulatory requirement, required to produce seafood products safely, and the fact that they had no idea what it was means demonstrated that that there isn’t any regulatory review or knowledge at the plant. Either this changes after this wake-up call, or FDA will eventually stop them from selling seafood having seen no effort made to be in compliance.

If you are interested in HACCP, I’ll probably cover many basic principles throughout this blog, but there are many people much smarter and experienced than me who have written solid books on the subject that can be very helpful for the studious. Otherwise there are a ton of classes and free online materials out there, go find what works for you!

For the purpose of addressing the manufacturers comments to FDA, let’s just say that HACCP is a food safety control system that requires not just “the plan” on file, but actual actions and documented controls during production based on that plan. Basically, the company saying “we’ll get one of those” is inadequate even if they were to get a paper copy stored somewhere onsite.

It would be like me asking you to get a job, and you responding that you’ll work on getting a job description to show me. You didn’t really get what I was asking for, and the piece of paper itself isn’t going to cut it.

On sanitation:

our investigator observed the interior surfaces of your shrimp roaster and shrimp grinder… contained red colored shrimp residues. An employee told our investigator the equipment had last been used in October, approximately two months prior to this observation…In your December 26th response, you stated that your employees had thoroughly cleaned the interior and exterior of the roaster of dried red colored shrimp residue. However, your response is not adequate. Your response did not address the cleaning and condition of the shrimp grinder, which was the other piece of equipment colored residues were observed.  Furthermore, you did not provide any corrective action to ensure this problem will not recur.

So a couple things here. First, this is a weird finding in some ways, because in general dirty equipment is dirty equipment, as long as it isn’t being used before getting cleaned it doesn’t pose a food safety risk necessarily in the same way a dirty cereal bowl in your sink isn’t a food safety risk. However, accumulation of food debris on equipment just hanging out in the plant is a source for microbial contamination and a pest attractant, and two months is pretty long to hang onto something covered with bits of shrimp (or spoiled milk residues in the aforementioned cereal bowl). FDA may have also suspected that the equipment was either being used in that condition, or would be used in that condition without cleaning.

The company’s response was inadequate because they didn’t actually say they cleaned each piece of equipment FDA identified as dirty (and should have included pictures as well).

“Honey, please pick Tommy up from basketball practice and Sue from daycare tomorrow”

“Okay, I picked up Sue! Are we done here?”

No, you’re missing something there. The other reason the response was inadequate is that FDA wants companies to demonstrate why this wouldn’t be a finding the next time they visit. Something along the lines of “we created a new equipment inspection program and policy where equipment may not sit idle for more than two days or a weekend without being cleaned of any residues. This is audited by our QA guy and the staff was trained…”. Just answering with “we did this because FDA asked us to” does not give confidence that the same situation won’t just happen when FDA isn’t there.

During our inspection, our investigator observed the hand washing sink located in the processing area lacked running water of suitable temperature for employees to adequately wash their hands, and the water running from this sink was not clear, but yellowish in color. In your December 26th response, you stated that the “water level flow has been cleared so that the water is clear” and your employees were “told to use so that water does not sit and get that yellow coloring.” Your response is not adequate because it does not address correction to the water temperature.

FDA requires warm/hot water for handwashing to be available, and certain standards require the water to turn hot within X seconds. In this facility, hot water was not plumbed to the sink or was on the fritz, and the water coming out was yellow in color, an indicator of pipe corrosion or some other issue.

The firms response was inadequate because they once again didn’t address all the issues. They focused on the yellow coloring by saying the lines just needed to be flushed. I pick up on this as another indicator that handwashing wasn’t actually taking place on this line since the water was stagnant and employees were “told to use” the sink from now on.

But even though the color was spoken for, the company didn’t continue and address the lack of hot water! Either they didn’t read their 483 or were hoping they could let that one slide by. Clearly FDA paid attention to the response and didn’t let it sneak through (good job FDA!).

On December 6, 2016, our investigator observed the wooden shelves in your outside shrimp drying room contained green colored shrimp residues and apparent insect excrement…In your December 26th response, you stated that the outside drying room was cleaned of the green shrimp residues as well as any droppings. However, your response is not adequate because you did not provide any corrective action to ensure this problem will not recur. You must take effective measurements to ensure pests are excluded from your food processing facility.

So residues of shrimp and insect excrement found on shelves inside a drying room. Once again they said “okay, we cleaned it up”, but FDA wants to know they’ll actually keep it clean and, for good measure, keep pests out of their food facility.

As a matter of fact, FDA ended up saying that directly:

 No pests shall be allowed in any area of a food plant. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). However, on December 6, 2016, our investigator observed the following:
a.  Apparent insect excrement, too numerous to count, were observed on a wooden ledge in the upstairs packing and storage area. Directly below the ledge were wooden crates storing unpackaged [products].
b.  Apparent insect excrement, too numerous to count, were observed on wooden shelves and directly on top of a brown-paper packaged bulk raw ingredient product, which were stored on the shelves, in the downstairs processing room.
Additionally, our investigator observed apparent termite damage on the wooden ledge and shelves of your noodle packing and storage areas. During our inspection, you informed our investigator that you were aware of termite issues in the building.

Here we’ve learned a few things. First, we now know that the “excrement” noted in the findings must be termite frass (google away). Second, the manufacturer noted that they use a facility with a known pest problem. Pest infestations are expensive to fix, but if you produce food, it’s not something you get to choose to ignore. FDA responded saying that the corrective actions to move products out of the area and place a tarp over the termite damage “did not address how you will correct the termite problem in your food processing building (emphasis FF&F) and you did not provide the action you had taken to resolve the presence of the numerous insect excrements we observed…”

Next time you are in a fast food restaurant, look around and see if you can spot an insect light trap (ILT). Often they’re decorative like the one in the link, and they work super well at immediately attracting bugs that make it through the door (or other openings). Facilities with preventative pest control will have these in areas where they will be most effective, attracting pests away from sensitive areas. This would have been a good step to try and prevent termite infestation or reinfestation, but at this point the problem is persistent, uncertain, and expensive.

our investigator observed your employee standing on top of a table adjacent to the dough hopper wearing street shoes, and a metal scrapper used to scrape in-process dough from the mixer into the hopper was stored on the table approximately ¼” away from the employee’s street shoes. In your December 26th response, you stated you will move the hopper slightly away from the standing employee shoveling dough and that the scraper will be placed away from the surface of the hopper. We will verify the adequacy of your corrections during our next inspection.

Here the company responded well and addressed the complete finding. First, the hopper was too close to the employee’s shoes (and thus, dust/dirt/fecal material and anything else they may have walked though on the ground), they got it moved away. Second, they moved the product contact tool away from a walking surface where it could have been contaminated. An easy fix, but they did it. FDA noted that they will inspect for it next time, which means they were satisfied. In other cases, FDA might still take issue if this type of tool storage was pervasive, and determine that this kind of response is inadequate. If there were multiple similar situations in the plant, they might not believe people will stop storing tools in these areas just because you corrected it once.

your firm uses wooden materials as direct food contact surfaces in the manufacturing of dried [product]. Our investigator observed in-process products were in direct contact with wooden racks, dowels, and crates, which were in disrepair, worn, and not easily cleanable

wooden-spoonWood + food=nono. While if properly cleaned, dried, and monitored for damage it can be used in the home, wood is still a porous material that can hold water and support the growth of microorganisms, and old wood can break apart and introduce foreign material (splinters) into products. The firm here says they’ll think about replacing these materials with plastic or coating them with plastic, so some of it must be specialty equipment they need to address and not just spatulas and spoons that could be easily and cheaply swapped out. This should be an easy fix for the company, however the storage crates could be a significant expense. Plastic crates aren’t cheap and they may need a lot of them to replace their wood ones.

Considering starting a food company and don’t know what sanitation standard you should meet? Many companies who receive warning letters fail to meet similar requirements enforced at the restaurant level, so check out the food code as a good place to start in an easy-to-follow format. If you think you can meet that standard, check out FDA’s extremely helpful page: How to Start a Food Business.

The information is out there for those who care to seek it.

 

 

FDA Warning Letters This Week 2/22/17

warning-letters

The week goes by and new letters come out. Looks like we’ve only got one food letter this week so let’s get into it.

Don’t know what warning letters are? Check out this post for a brief overview of what they are and why FDA sends them out.

WL# 17-PHI-04

CDC Public Health Image library #2287 Credit Elizabeth White (2002)
CDC Public Health Image library #2287 Credit Elizabeth White (2002)

Subject: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes

Ohhhhh it’s an L. mono letter, always interesting. Already we have to pause for some background.

At the end of 2013, CDC and FDA partnered up to stop foodborne outbreaks of Listeria monocytogenes through the utilization of whole genome sequencing (WGS). This technology used to be effectively impossible 30 years ago, and prohibitively expensive and time consuming even 10 years ago.

What this means is that when L. mono is found in foods or a sick person in the hospital, they can sequence it’s entire genome to determine how closely it might be related to other L. mono cultures found in the network. The network consists of genome databases Pulsenet, GenomeTrakr, and The Listeria Initiative, which are jointly managed by CDC, FDA, and local health departments.

Once L. mono has been found and sequenced, in tandem with a traditional epidemiological investigation (interviews, additional sampling of products and environments, illness reporting), the sequence is compared to those in the database to determine if the strain that was found is “closely related” to others and see if there is a link. This is how the listeria found in the Blue Bell products/plant was traced to 10 illnesses that occurred as early in 2010, even when the listeria in the ice cream wasn’t found until 2015. Across several states and 5 years no firm link was established until WGS sequencing revealed the relationship.

There’s some debate about how transparent CDC is about determining when related isolates are causal, or to what level this data should be considered definitive in the absence of confirmed positives in products. However, FDA is going full steam ahead with using WGS as a new enforcement and Epi tool, and CDC has some good data to support the effect on outbreaks it may have had. Whether that’s because manufacturers are more careful in light of the enforcement activities or because the enforcement activities have prevented outbreaks is unclear. But no matter the end result, it’s a win for public health.

The last bit of debate is as to the extent that L. mono can be considered an adulterant. Here in the U.S. we’ve made the determination that if there is any present in the food, it’s adulterated. This is different from several other countries, including Australia/New Zealand and the UK, which allow a non-zero legal limit if L. mono is not expected to be able to grow in the product over it’s shelf life. There’s debate over that as well.

So back to the warning letter:

FDA’s laboratory analysis of fifty environmental swabs collected on September 12, 2016, confirmed that eighteen of the fifty environmental swabs were positive for L. monocytogenes. Of most importance:

Three positive environmental swabs were collected from the following direct food contact surfaces in your cheese processing room during the production of your RTE cheeses:
  • The top of the cheese slicer
  • The cheese slicer string
  • The inside of a plastic crate used to store finished cheese before packaging
–    The remaining fifteen positive environmental swabs were collected from locations adjacent to food contact surfaces and from non-direct food contact surfaces.
–    One positive sample was collected from your RTE feta cheese

They also found a positive in unpasteurized cheese during the facility visit.

This is a pretty solid connection given they found Listeria in the product itself, especially a post-pasteurization product, and that they found it on product contact surfaces where it could continuously inoculate that pasteurized product.  There are other warning letters that claim the products are adulterated when “we found it in the threshold of your entryway to the plant” that don’t always feel solid, but this one is not one of them.

On September 12, 2016, the lift arm and bowl support brackets of the mixer contained areas which appeared to be rusted and contained rough surfaces. In addition, the beater shaft housing area of the mixer, directly above the bowl support brackets, was observed to contain areas which appeared to be rusted and contain food particulates and/or foreign matter.
Food processing tools like my hand mixer have hard to clean areas that can collect food particles like cookie dough, you’ve got to check those areas every time!

Rust happens, and plants have to do regular walkthroughs and replace what needs to be replaced as it ages. But even with the best of intentions, not everything always gets replaced by the time FDA walks through. This makes it a common violation (do you have any rusty or damaged bowls or pots in your cupboard that you plan to replace soon?). But the food particulates are a good find and an indicator of a less-than-robust sanitation standard. Small, hard-to-clean areas around bolts and inside moving parts like the underside of a kitchen-aid (see picture to left) don’t get properly inspected and cleaned unless you have a dedicated program to seek these areas out.

The floors in the processing room and walk-in cooler were observed to be in disrepair, containing areas where the concrete is cracked, rough, and peeling

This one is also common, as mentioned on this site before, cracked/pitted/porous floors are a potential point where environmental pathogens like listeria and salmonella can hide from getting properly cleaned, waiting to jump back out. It’s also a common finding because refinishing or extensive repair of floors is expensive, normally planned on a long-term basis (maybe the slow season so the plant can close or when the contractor has availability), and because in other manufacturing industries it isn’t always a problem (e.g. machine shops).

We have reviewed your written responses to the Form FDA-483, received October 24, 2016, and December 7, 2016…We will ascertain the adequacy of your corrective actions during our next inspection.

Also as discussed here in the past, this is a good sign that FDA knows this company is taking the findings seriously and making real change. Otherwise they would respond with “this is inadequate” and request additional action or proof of change before closing the letter.

Greater than twenty flies landing on the floor, food processing equipment, food processing utensils, and other food contact surfaces and non-food contact surfaces…Three fly catcher tapes containing multiple flies hanging in different areas of the processing room… Dead flies on the window sills near the batch pasteurizer and three bay sink areas.

Well, they had fly catchers, so they know that flies aren’t supposed to just keep flying around, so there’s that. The manufacturer responded that they would purchase a fly zapper and new tapes, but FDA wasn’t satisfied. With pest control, you’re supposed to keep them out of the building and away from your products. So your interventions need to prevent access (find access points, block holes and unscreened windows, create breezeways and air curtains, etc.), and keep them from getting to products with interventions like ILTs.

Your maintenance of the grounds is inadequate to protect against contamination of food, as required by 21 CFR 110.20(a)… Live chickens and pigs coming within approximately one foot of the main door to the production facility and what appeared to be remnants of dead chickens and goats in close proximity to the production facility…Multiple items within approximately twenty feet of the outside perimeter to your production facility which may constitute an attractant, breeding place, and  harborage areas for pests, including, but not limited to, a chicken coop, an abandoned truck, a small four-wheeled loader, wood paneling, vegetation over six feet tall, and other small items which appear to be refuse.

Yep, sounds like a small farm/dairy. I can just picture it, can’t you? Some animals wandering, tall grass, chicken coop, and a couple old trucks and tractors getting overtaken by weeds

Outside of the animal carcasses (obvious pest and disease attractant), this is FDA throwing a little muscle at this farm to clarify that they need to treat it as a food processing facility and not as just a farm. The letter indicates that the company took action to clean up all of these items, however FDA was unsatisfied because they apparently didn’t send them pictures of the cleaned up areas nor discuss how they would keep livestock from hovering around the entrances of the food plant. FDA again noted that they would confirm the changes made were effective at the next inspection, continuing to show that that the inspection itself and initial 483 response must have gone well and the company is doing the right things post-inspection.

Sounds like this company has some work left to do, and that in this case FDA found some tangible and realistic findings of sanitation and facility problems. It helps that the findings were also supported by the L. mono data to really drive home to the company why they should be doing these things. Always nice when cause and effect tie together with GMP’s to drive positive food safety changes home.

New FDA 483: Euthanasia drug found in canned dog food, misc. facility findings, and questions for FDA

fda-483-footerI would be remiss in the goal of this blog if I didn’t do some digging into the form 483 that was just released by FDA this week following a recall for canned dog food containing Pentobarbital. For information on the products recalled and company involved check out the FDA recalls page and search for the issue. As usual I’ll refrain from writing company and product names on this blog when there isn’t any pending civil or criminal action associated with an event. But that information is readily available for anyone by clicking through the links or performing a simple search.

The 483 is short, just two pages. What the goal of this post will be is to go over each of the observations and try to provide additional information that isn’t included in the document to hopefully provide a complete picture.

All FDA observations began with the heading clarifying which portion of the law (FDCA) the firm violated:

The following observations were found to be adulterated [sic] under the Federal Food, Drug, and Cosmetic Act: A food shall be deemed to be adulterated if it bears or contains any added poisonous or added deleterious substance that is unsafe within the meaning of section 402.

This wouldn’t be FF&F if I didn’t pause here for some definitions. Adulterated is a condition of food by which it cannot be sold in commerce. It includes both reasons of safety as this case demonstrates, but it could also be forms of “economic adulteration”, where something claims to be what it isn’t or has otherwise been robbed of characteristics that the consumer would expect. Like if I were to sell you caviar but it was actually flavored gelatin balls or something.

Poisonous or added deleterious substance is a substance that when added to food “may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.” (emphasis mine)

FDA says two things there. First, don’t add anything poisonous to food (Protip). Second, if the food happens to contain something poisonous naturally, you need to make sure it occurs at a level where it isn’t toxic. This is the often cited”dose makes poison” principal. An example would be that I can’t sell food into which I accidentally spilled some cyanide (whoops) no matter how much or little it was, but I can sell fruits that may have trace amounts of cyanide precursors in the seeds, because it’s not expected to cause an issue in both the actual dose of the seeds and the expectation that people will avoid them when eating. This clarification is actually pretty critical as we try to make sense of past FDA guidance in this case and why the food was adulterated.

So, how did these dog food products cause themselves to be adulterated?

Your low-acid canned dog food product…was found by chemical analysis to contain the barbiturate drug pentobarbital.

By Harbin (Own work) [Public domain], via Wikimedia Commons
By Harbin (Own work) [Public domain], via Wikimedia Commons
Pentobarbital is a sedative that in the form sodium pentobarbital is used as a euthanasia drug. This recall/483 event was initiated when 5 dogs became sick and one subsequently died. Several new updates have occurred since then and I encourage you to follow the story on a site like food safety news.

Here’s the thing about this finding, it’s annoying that the 483 made no mention of the dose that was recovered. This is important because FDA did a study on pentobarbital in dog food in 2002. In that study, the samples (not randomized/representative, convenience samples selected for likely positives) tested positive for the presence of pentobarbital in more or less than 50% of the samples. However, in the same study FDA made a determination of dose that caused adverse effects:

Based on the data from this study, CVM scientists were able to determine that the no-observable-effect level – which is the highest dose at which no effects of treatment were found – for pentobarbital was 50 micrograms of pentobarbital per day

Dogs would have to consume 5-10 micrograms of pentobarbitol per Kg body weight to hit that dose. The highest value FDA found in their samples was 32ppb (32 micrograms per Kg of food). This means that 7 Kg (15.4 lb) dog would need to eat between 35-70 micrograms to reach the minimum dose, which would have been a little over 1Kg of the highest testing food. Pet food isn’t very dense (canned pet food is denser but contains more water that dilutes other ingredients) and 2.2 lbs of it is a lot of food for a 7Kg dog. Therefore FDA concluded:

the results of the assessment led CVM to conclude that it is highly unlikely a dog consuming dry dog food will experience any adverse effects from exposures to the low levels of pentobarbital found in CVM’s dog food surveys

Which means that FDA concluded that the mere presence of pentobarbital does not make the product adulterated because “the quantity of such substance in such food does not ordinarily render it injurious to health” per the FDA study.

Now, because there is report of adverse events and an Oregon State College of Veterinary Medicine report out there showing that the levels in this food were high enough to cause an effect, this food is clearly adulterated. But it seems like FDA should have included a note about the concentration of the drug found in the food in this 483 to clarify why it was legally adulterated, given the past study.

Now for the findings not related to the chemistry analysis and recall:

Condensate dripped throughout your processing facility from the building…including condensate dripping directly into open cans of the in-process low-acid canned dog food product…and also into multiple open totes of raw meats including beef intended for your canned dog food product

steam-hood
Example: steam hood over my stove that I apparently need to clean…gross.

Condensate is found wherever foods are heated and cooled, and FDA has been addressing it more and more. Condensate was noted in the Blue Bell 483’s as well. The logic is that while steam or vapor may be clean, once it collects on a surface like the ceiling or whatever else, it can carry bacteria from these “non product contact” areas back onto your food. Think of it this way, would you lick the underside of the steam hood/vent above the stove if you hadn’t just cleaned it? Now imagine that the steam from your stroganoff was condensing on the underside of the hood and dripping back into it, carrying all that old grease and dust. Yum.

The floors throughout your processing facility are pitted, cracked, and otherwise damaged causing pooled water in areas where food is exposed including where open cans of…dog food are staged

pitted-concrete
Source: my patio.

Uncleanable floors = environmental pathogens. While they didn’t go on a “swab-a-thon” in this facility (yet), uncleanable floors are essentially considered harborage points for things like Listeria and Salmonella. In any other business than food, pitted floors aren’t normally an issue, which makes it a common finding in plants holding themselves to a manufacturing efficiency standard rather than a “food grade” standard.

Additional sanitary conditions observed…include peeling paint and mold on walls throughout the processing facility including in areas where food is exposed, a live fly-like insect in the …hand-packing area during processing, and an open sanitary sewer within approximately 25 feet of two food storage trailers and one food processing trailer at the rear exterior of the facility.

Really just shows a lack of preventative maintenance and facility investement when there wasn’t a clear ROI. This particular company has been in business for a long time in the same location, so it’s possible they themselves put that old coat of paint in years ago to spiff it up and make it look nice and be good for food. These kinds of things are expensive preventative maintenance tasks (mold removal, repainting) because it causes downtime as well as the expense of the repair. Typically FDA will show discretion depending on risk to product (e.g. if you only have closed containers in a room with old paint), but the inspectors here probably determined that this was facility neglect and should be noted. Same thing happens in restaurants and retail establishments where facilities have aged but there’s been no spiffing up.

You lack operating refrigerated storage facilities or other means of controlling the temperature exposure of raw meats during thawing, storage, and processing.

Ding, ding, ding! We have a winner, here’s where we demonstrate the true lack of food safety commitment/appreciation at this facility. The last findings all relate to proper temperature control:

…raw beef and other meats in various stages of thawing were stored in ambient temperature inside your processing facility and also at abmient temperature inside three trailers…the exterior ambient temperatures were below freezing…there was frozen ice containing a blood-like substance across the floors of the three trailers and also on the ground…

Open cans of beef were staged on a pallet at ambient temperature during the hand packing process [from the start of operations until 2:00 PM]

So here’s what the deal is with food safety here. This product is going to be retorted, which means that as a low-acid product, it’s going to be cooked until it’s commercially sterile.

So, in theory, it doesn’t matter if your raw meat doesn’t stay refrigerated, since you’ll kill anything that might grow on it! Heck, you can pack it in a dirty facility with dirty tools if you wanted to…

That was sarcasm.

Processors who think like this fail to understand how cooking and kill steps work, and don’t have respect for your food at all stages of production.

FDA expects the thermal process for low-acid foods to provide a minimum of a 5 or 7-log reduction for spores and pertinent pathogens. What this means is that the process should destroy a minimum 99.999% of spores/bacteria in the product, or alternatively, it would sterilize meat that contained 10,000 spores/gram (bacteria are easier to kill than spores, and would have a much higher log reduction with the same process).

This would work for most “raw” products used in this process. However, if you don’t refrigerate or otherwise control raw meat to keep it out of the danger zone of 40-140ºF, bacteria will start to grow. And with the average piece of beef trim having anywhere from 100 to 100,000 bacteria/gram, if these bacteria are allowed to multiply to the ten-millions from lack of refrigeration suddenly that 5-log reduction doesn’t work anymore!

99.999% of 10,000,000=100

While 100 un-killed spores may not seem like much, one of them could be C. botulinum, and with a shelf life of years in a can of dog food, it only has time to grow.

Take this home: every cook or “kill” step in food processing has a log-reduction value. So while you can technically cook spoiled meat until all the bacteria are dead, you have no way of knowing (without testing) that your standard procedure of cook until 165ºf will work if the number of bacteria are 100 fold higher than what the cook was intended for.

If you still think you can throw away your refrigerator and just cook everything through, I recommend purchasing an autoclave to really sock-it-to-em. Don’t think what comes out will be very tasty though. Oh, and general autoclave parameters will give you a 12-log reduction. Happy cooking.

While this is a significant finding, it isn’t related to the issue causing the current recall (and subsequent enforcement). The issue with the product had to do with pentobarbital in the food, which is a supplier sourcing issue (pentobarbital didn’t make it’s way in at the plant unless it was a malicious act). This plant has had a poor history with supplier approval (sourcing duck that wasn’t actually duck for example), and also has a history of being ignored by the FDA based on inspection history.

What this warning letter serves to do is show that FDA is doing it’s job (or backtracking to do so) enforcing all the regs at this plant regardless of the specifics of the current problem. But I have a lingering problem with this timeline:

12/31/17: Dogs become sick after eating the implicated food.

1/3/17: Oregon State University receives the samples for autopsy and analysis, report indicates FDA was informed.

1/10/17: FDA shows up at the plant to perform inspection that led to the facility 483 findings

1/17/17: Michigan State University confirms Pentobarbital contamination

2/1-2/2/17: FDA continues inspection according to the 483, no new findings noted from the later dates

2/3/17: Recall initiated, presumably this was a result of the meeting with FDA from the previous two days where they informed them of the results and helped identify the scope of the recall and “recommended” a “voluntary” recall.

2/8/17: FDA continues inspection according to the 483, no new findings noted from later dates.

2/17/17: FDA releases their own independent press release through CVM updates

This facility had multiple problems in 2011 and 2012 that led to FDA action, and FDA had last interacted with them (according to the inspections database, which does not include contracted inspections through the state) on 2/28/13.

Did FDA inspect a facility, find problems, and then decide not to go back for 4 years? And from this timeline above, did they only go back to this facility because they had a potential poisoning related to it on file?

Thorough and rapid response to a crisis FDA, good job! But shouldn’t you have been inspecting a known problem facility to prevent problems like this from happening?

After all, in 2011, you said this:

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.

We can’t say whether increased visits from FDA (which should have been every 3 years at minimum) would have prevented this from happening. But it certainly couldn’t have hurt.