Presence of fecal coliforms does not mean “there’s poop here”, but for aspiring poop-hunters is there an alternative?

Image created by Austin Bouck. Dear god let there be no egregious mistakes…

Recently a podcast I often listen to has discussed several articles with a similar note in their conclusions.

Nearly half of the 90 beverages from soda fountain machines in one area in Virginia tested positive for coliform bacteria — which could indicate possible fecal contamination

The study, conducted over six months at six licensed day-care centers in California, found high levels of coliform contamination, particularly in kitchen areas and on the hands of day-care workers. Coliform bacteria are transmitted through feces.

But recent reports reveal that the coffee or tea you’re sipping  – and even the cash you used to pay for it –  also carry bacteria found in feces.

Seven out of 10 samples of Costa ice were found to be contaminated with bacteria found in faeces.

40 percent of office coffee mugs contain coliform bacteria, which can be found in feces.

I don’t need to rehash arguments that have already been made here. Fecal coliform is a group of organisms historically used to identify whether drinking water could be contaminated with sewage or fecal material. Because it’s still a valid test to determine if water has been contaminated (they don’t survive forever in clean water, so if they’re present it’s because there’s a likely a failure in the system), the CDC and tons of state regulations still falsely state that these organisms are only found in fecal material.

Part of the issue is that coliforms as an indicator in general were extrapolated to environmental samples and food. NACMCF summarized the most recent scientific conclusion:

…whether coliforms, fecal coliforms, Enterobacteriaceae or E. coli. Kornacki and others (Kornacki et al., 2013) provide an historical evaluation of these criteria for foods and their utility based on current knowledge. None of these criteria accurately and consistently reflect fecal contamination of raw and processed foods nor are they useful or reliable as index organisms predicting the presence of pathogens.

The Kornacki reference is from the Compendium of methods for the Microbiological Examination of foods, which while expensive is an excellent reference for any food micro lab:

The debunking of the coliform=feces absolute conclusion was well covered by Doyle and Erickson in 2006, and more recently some thoughts were posted by barfblog.

But I’m writing this post today because I have a follow up question,

How exactly would someone actually test for fecal material?

Apparently, this is actually a problem in forensics, as an article published as recently as 2013 stated”no sensitive and simple fecal identification method using molecular biological techniques has been reported.” (Nakanishi et al., 2013). Here were the methods I was able to find with a cursory review of the literature.

1. Direct (macro) observation

A.k.a, the stain on the tighty-whities. Feces can be identified from it’s characteristic green-brown color from bile digestion and characteristic odor…this detection method isn’t really worth going into and I apologize for the mental image/odor.

2. Microscopy

Now we’re getting sciencey. Fecal material is a hodgepodge of various microscopic indicators. An experienced eye would be able to find bacteria (the bulk of the dry weight), but also undigested food particles and cellulose cell walls from plant material. Some epithelial and mucousal cells from the GI tract would also be visible. Interestingly, one way to determine if the fecal material was from a person or animal would be to look for excess hair in the sample, either from digesting prey or from grooming. The hair has to go somewhere, and I’m really curious if you would see a difference in hair mass between bearded and clean shaven men…

3. Chemical Indicators

Urobilinogen is a byproduct of bilirubin metabolism, and will be found in animals which consume meat and/or are otherwise digesting blood.  This appears to be a fairly classic test to discriminate fecal material from other bodily fluids like sweat or saliva and can be performed on site using a fluorescence indicator solution. Unfortunately, urobilinogen can also be found in urine since it is also returned to the kidneys for excretion.

4. Microbiological Profile

Well, crap. Here we come full circle. The most recent research on this subject seems to be using newer sequencing techniques to identify the unique organisms in the microbiome of feces. The goal is to find specific organisms or genes that would allow forensic scientists to discriminate between fecal material and other bodily fluids.

Here’s the thing though, none of the research identifies coliforms as a group of interest. It’s too broad and unhelpful! Rather than traditional “fecal bacteria”, the Bacteriodes genus has been identified as the predominant organism group in feces. Specific organisms identified were B. uniformis, B. vulgatus, and B. thetaiotaomicron. However, the state of California has specifically identified these organisms thriving in marshlands, yet still attribute them directly to feces. It would seem that again we can infer that fecal material is likely to contain these organisms, but it seems improper to assume that the presence of the organisms means that fecal material was the source.

I’d love to hear from some forensic scientists on what I got right and wrong here. From what I can tell from the literature it seems like there isn’t as much forensic interest in fecal material. The authors referenced how it is hard to isolate DNA due to interference from bile enzymes and microorganisms, which would reduce its value as evidence.

It seems like at this time a definitive test for “there is poop on this plate/ice/food/hand” doesn’t exist.

Much to the chagrin of PCRM, who would like us to declare the invisible feces on our meat.

Maybe we can just stop making the correlation between feces and food hygiene and instead focus on pathogen detection/prevention/pervasiveness as a means to evaluate foods on the market. While we talk about the fecal-oral route a lot, we’ve known for a long time that pathogens can be found almost anywhere if you start looking, so let’s look for them instead of fecal coliform clickbait (which this post totally is).

 

 

Resources for fecal identification forensics:

Drexler, Judith Z., et al. “Marsh Soils as Potential Sinks for Bacteroides Fecal Indicator Bacteria, Waccamaw National Wildlife Refuge, Georgetown, SC, USA.” Water, Air, & Soil Pollution 225.2 (2014): 1861.

Forensic Resources.Serology – Blood and other Bodily Fluids. http://www.ncids.com/forensic/serology/serology.shtml

James, Stuart H., Jon J. Nordby, and Suzanne Bell, eds. Forensic science: an introduction to scientific and investigative techniques. CRC press, 2002.

Li, Richard. Forensic biology. CRC Press, 2015.

Nakanishi, Hiroaki, et al. “Identification of feces by detection of Bacteroides genes.” Forensic Science International: Genetics7.1 (2013): 176-179.

Virkler, Kelly, and Igor K. Lednev. “Analysis of body fluids for forensic purposes: from laboratory testing to non-destructive rapid confirmatory identification at a crime scene.” Forensic Science International 188.1 (2009): 1-17.

Zou, Kai-Nan, et al. “Identification of vaginal fluid, saliva, and feces using microbial signatures in a Han Chinese population.” Journal of forensic and legal medicine 43 (2016): 126-131.

USDA-FSIS Quarterly Enforcement Report: Downloadable Raw Data and 10 Year Trends

data-graphicIn my mass of emails from the government each day, every quarter I get one from FSIS letting me know what they’ve released their quarterly enforcement report. These reports detail actions taken against specific establishments, as well as details on how many enforcement-type actions are taking place ongoing.

I have a problem with this report however. It’s presented as a pdf with no metrics or historical data to put the information in context. FDA has done a good job in the past few years at releasing metadata in formats that allow analysis (CFSAN adverse event reports, inspection database, etc.), but USDA takes the time to kick out this report without showing what the trends are.

Alright raw data nerds, here at FF&F we’ve got your back. For all your analysis needs, we’ve collected a few of the more “top level” reporting numbers from reports going back to 2007, and put them all in excel for you to strip apart and analyze to your hearts content. We’ll even keep updating this spreadsheet and re-uploading every quarter ongoing.

fsis enforcement reports data (.xlsx)

Because some of us like bringing home a growler on a Friday night and entering data to do basic trending on government statistics, here are some of the trends I found interesting that aren’t visible by looking at any one of the individual reports, I’ll update these in the event that any new trends appear, the newest observations are posted first to keep the fresh content up top for you subscribers, the older ones are still relevant and listed below.

New!  Total meat/poultry subject to standard re-inspection and refusal.

 

 

 

 

 

The overall lbs of meat/poultry product presented for routine re-inspection has remained high with no trend change, but new this year is a sharp increase in the number of lbs that were subject to additional inspection or outright refused. I’m guessing this is a direct result of FSIS implementing 100% inspection of Brazillian beef in May of this year and subsequently rejecting all beef from Brazil. In case you missed that, Food Safety News did an excellent job covering the JBS bribery scandal and tainted beef coming from Brazil.


verification-procedures-performed

These are the number of individual verification procedures performed by FSIS inspectors each quarter. We can’t speak as to why there was such a change in 2010-2011, as these numbers could simply have started being calculated differently in the system. But NPR had some data to suggest that overall meat consumption started declining in 2010, which could lead to fewer establishments or approved inspection hours, and thus fewer verification events.

compliance-rate

Compliance rates have always remained above 98% (meaning that 98% of all verification activities end with an inspector going “okay, you’re doing the right thing here”). But like overall verification, compliance seems to have a slight downward trend as well. It’s hard to say this decline is significant since the standard deviation of these percentage data is only 0.0016, but the whole point of getting this data organized to demonstrate the trend is to keep tabs on things like this. It’s hard to never have a downward trend when you hover near 100%, but it will be interesting to see if there is any FSMA effect in the next few years on this trend in either direction.

percent-of-nr-appeals-that-were-granted

That 2% noncompliance rate is a count of Noncompliance Records (NR’s) that are issued. Per FSIS:

An NR is a written record that documents noncompliance with FSIS regulations. An NR notifies the establishment of the noncompliance and that it should take action to remedy the situation and prevent its recurrence. Noncompliance reported on NRs varies from non-food safety issues to serious breakdowns in food safety controls.

When an establishment fails a verification activity, it is issued an NR and has the option to appeal if they think an observation was out of context, the inspector was incorrect in his/her interpretation of the regulation, or some other circumstance led them to believe the finding was incorrect. The graph above shows that historically about 1/3 appeals are granted by regional offices/DC when establishments challenge an NR. But in recent years that number has dropped from around 35% to 30%. This could have also contributed to the increased number of noncompliances observed earlier, now that fewer appeals are being granted.

percent-livestock-carcasses-condemned-of-those-inspected

The poultry carcass inspection/condemn data didn’t have any interesting trends, it swung up and down without a lot of overall variation. The livestock carcass data was more interesting in that it seems to have a sustained downward trend.  This could be to better herd health in the last decade or more efficient slaughter practices that result in fewer condemned carcasses from injury or contamination. While the cause is uncertain, as long as it isn’t the result of poor or inconsistent enforcement, this is a great trend! Fewer condemned animals is better for the animals and the environment.percent-meat-and-poultry-refused-on-inspection

I’m not sure this paints a completely accurate picture, but the data points were real, they actually wrote zeroes in the older reports. While the number of products imported has increased overall, this % refused trend shows that even though imports are increasing, we’re also rejecting more meat at the border than ever before. You can check out this FSIS directive to learn more about inspection of imported meat and poultry and what refusal criteria might be.

If you’re more intense than I am and want to do advanced statistics that excel can’t handle, you can see what’s out there in terms of software and let me know if you discover any new insights from this data! The spreadsheet and all graphs were created from source data in the FSIS quarterly enforcement reports.

 

ResearchBlogging.org

USDA/FSIS (2017). Quarterly Enforcement Report for Quarter 1, Fiscal Year 2017 United States Department of Agriculture

FDA Warning Letters this week 11/2/17: A gift from FDA to QA staffers reviewing product labels

The week goes by and new letters come out. Below I’ve selected a few of the food-oriented warning letters and discuss/explain some of the more interesting findings.

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-ATL-12

Subject: Food Labeling/Misbranded/False and Misleading

The labeling requirements for food are so complicated, that the guidance documents for them are in the hundreds of pages. It’s the responsibility of those folks involved in compliance to review labels and claims to ensure that their company doesn’t end up in trouble, but that can mean being the bearer of bad news. While QA/regulatory folks get buried in the details, other stakeholders only understand labels from what they see in the market from products they buy or competitor products.

Oftentimes, QA folks have the fun job of saying “that’s not technically what the law says”. This is the risk assessment version of label review. The next step then, is risk management, in which other folks may ask the question of whether FDA/FTC are actually enforcing these rules, some of which are nestled in very grey areas and/or not commonly followed!

Often when evaluating the enforcement side of the law, good QA personnel turn to warning letters to see which portions FDA is actually enforcing. Unfortunately when labeling is enforced on the food side via warning letter, it’s never for the soft grey area stuff. FDA mostly enforces misrepresentation of product, health/function/unapproved drug claims, having components straight up missing (e.g. “you didn’t have an ingredient statement“), or allergen mislabeling (which is a food safety issue). We get very few examples where FDA has actually verified nutrition values (for which there wasn’t a claim), corrected serving size errors, or identified other interpretation issues.

So, in a blog that offers plenty of criticism, let’s take a moment to say:

Thank you FDA!

Visible enforcement actions on labeling deviations help everyone keep their marketing teams in check. Regulatory professionals have so much more ability to push for accurate and fair labeling  when they can actually demonstrate that it’s being enforced elsewhere.

Okay, so exposition over, let’s get into the actual findings of this warning letter:

In June, 2017, FDA actually collected a sample of this product (crackers) from a retail store and tested it for nutrition against the values in the nutrition facts panel.

This is super cool. And while FDA is clear in the regulations that it has this power (and explains to manufacturers how these samples are collected) you never really hear about it happening.

 The product label states one serving is one package/ 6 crackers and contains 10% of the Daily Value for iron. However, the sample analysis performed by FDA found the product to contain 51.7% (original) and 57.2% (check) of the declared amount….Based on these findings, your product is misbranded under Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading. Specifically, the iron content is less than 80% of the amount declared on the label [21 CFR 101.9(g)(4)(ii)].

Okay, so real quick and dirty discussion about nutrition labeling and how far your numbers are allowed to be off.

How far off from label is too far?

Basically, while still operating within “good manufacturing practice”, FDA created three groups of ingredients.

Class I ingredients  are vitamins and minerals that are added to “fortified” foods. These are ingredients that consumers see as beneficial, that you’ve now made marketing claims about, and that you would have a economic incentive to over declare. So  when your food is tested, these nutrients need to be present at 100% of the labeled level or higher. If you say it has 40mg of vitamin C, you better have at least 40mg. It can contain 50 or 60 with no problem, but it shouldn’t ever be below what you’re claiming, which would be interpreted as misleading your customer to sell more products without adding the ingredient.

Class II ingredients are the “good” stuff in normal foods that aren’t claiming to be “fortified”. Things like vitamins, minerals, protein, total carbohydrates, dietary fiber, unsaturated fat, and potassium that people like to see in their food (e.g. “I’m looking for a high protein snack“). These again are “beneficial” ingredients to consumers, so you would have an economic incentive to say they were higher than they actually are (or over declare them). When your food is tested, these nutrients need to be present at 80% of the labeled level or higher. If you say it has 8g of protein per serving, FDA gives you a little wiggle room since values will vary between crop years etc. (potatoes will change a little year to year based on rain etc.), but would rather you under declare to make sure no one is misled by the label.

Class III ingredients are the “bad” stuff that people are trying to avoid. Things like calories, total fat, saturated fat, cholesterol, and sodium (and sometimes carbohydrates/sugars). These you would have an incentive to under declare or say there was less of the bad stuff than there really was (40 fewer calories per serving than our competitors!). When your food is tested, these nutrients need to be present at 120% of the labeled level or lower.

Back to the letter…

So this company got in trouble for violating the rule for class II ingredients, in that the actual tested value for iron was more than 20% less than the label said. Assuming that this was an honest mistake, this company would have done well to truncate their labeled values for iron downward, as FDA says in their guidance:

Reasonable excesses of class I and II nutrients above labeled amounts and  reasonable deficiencies of the Third Group nutrients are usually  considered acceptable by the agency within good manufacturing practices.

So don’t just label your protein as zero to make sure you don’t get in trouble, but if you tested at 2 grams and decided to label just 1 gram to make sure you were good to go, FDA is okay with that.

The information panel labeling does not meet the requirements in 21 CFR 101.2(e) because the bar code is intervening material within the ingredient list.

The “information panel” is a term that refers to the section of the label you decided to place the nutrition facts, ingredient statement, and place of manufacture. Technically it appears directly to the right of the “principal display panel” which is what you see facing you on the shelf, but that rule is very rarely enforced provided you don’t deliberately hide it.

The nutrition facts, ingredient statement, and place of manufacture (signature line) have a requirement that they all need to be touching each other with “no intervening material”. This is a common one for companies trying to make their labels look pretty to mess up. Things like logos, preparation instructions, or romantic copy (things like company story or description of the product) can’t be stuck in there between your ingredients, nutrition, and contact info, they need to be in one single unit so that people don’t need to go looking for them all over your package.

Intervening material...is a crisis
See how you can’t separate out the regulatory portion with “stuff”?

 

The product label does not declare the street address of the firm. Under 21 CFR 101.5(d), the street address is required unless it is shown in a current city directory or telephone directory.

We don’t have the label to review here, so we can’t say what information was on the label. But I have a haunch as to what happened with this product. It’s for sale on Amazon in large multi-packs, but fda stated that their package was 1.75 oz. I’m guessing complete contact info was available on the larger, bulk package, but the retailer was selling individual 1.75 oz packages. They may not have included all info since they didn’t wholesale the individual packets, just the cases. But since the individual packets were consumer facing packaging, they are required to contain all the pertinent information just like every candy bar and stick of gum.

On a separate note, in the internet age, the 1994 standard of “shown in a current city directory or telephone directory” is absolutely an obsolete one. I can readily find this business and contact information online, and it’s silly to assume that the same access isn’t available through the internet as a phone book. The minimum standard of name/city/state/zip is still helpful to search for businesses with generic names that may be harder to find.

As you may already know, FDA finalized new requirements for nutrition labeling on May 27, 2016. The new Nutrition Facts label includes updates to the required nutrient declarations and formatting requirements. Although FDA has proposed  to extend the initial compliance dates of July 26, 2018 or July 26, 2019 (depending on the size of the manufacturer), manufacturers may begin revising labels now to meet the new requirements.

Bold, FDA….bold.

This isn’t a finding, just a comment that FDA would like to see the updates to this label include switching to the new nutrition facts panel format.  However, I take issue with them trying to rush this particular manufacturer given that FDA is supporting extension of the deadlines despite many manufacturers already having completed in the 16 months since the rule became final, and the original deadline still 9 months out for large businesses.

Summary

This is a great warning letter to keep around. It’s a clear example of FDA both performing market surveillance on single serve products for compliance, as well as actually testing products to compare to the nutrition facts panel in the absence of a nutrition claim, which is very uncommon.

For businesses evaluating their labels for risk of enforcement, I offer the following business risk approach if you find yourself making decisions in the “grey area”.

  1. Food safety issues are non negotiable. Label content must NEVER put a consumer at risk.
  2. Has this issue been enforced based on the evidence available in warning letters or class action lawsuits?
  3. Is your product at “high risk” for label scrutiny by either FDA or consumer advocacy groups? Labels that are easy targets are those that: are dietary supplements, are fortified, contain nutrition claims on the label, contain health claims on the label, is intended for children, or are connected to a brand that makes nutrition/health connections in their marketing materials or website.
  4. Does the discovery of your use of the “grey area” show that you had an economic motivation to stretch the rule? I.e. did you deliberately mislead potential customers in order to gain a business advantage over your competitors or current industry trends?
  5. Is your decision defensible within the “must/shall” of the CFR?
  6. Always ask your marketing team, why do you want this? If the answer is that not doing it would affect purchase intent, that’s an obvious sign that consumers do value the issue, and you’re intentionally misleading customers.

Use these questions to decide how hard to push for the “spririt” of the labeling regulations, which is always to protect consumers from misleading business practices, as well as encourage fair competition among food producers.

Sell your product, not the label.

 

4th grade presentation: water treatment on the Oregon trail

Austin Bouck classroom presentation
Apparently I have T-Rex arms here…I was excited!

I had the honor once again to make a presentation to two 4th grade classes at a local elementary school during their Oregon Trail unit. The question posed to the students was:

Your wagon train has broken down, and you need to find water for your entire group. What can you do to make sure the water is safe?

I came in to cover the topic of water treatment. The presentation was based on several key points:

  1. What kinds of hazards/dangers do you need to address with water (or food in general)?
  2. What did pioneers on the Oregon trail know about these hazards in 1811-1840? (hint: no germ theory yet)
  3. Which hazards do different treatments address, and which ones would have been available at the time?

The presentation consists of me blabbering and motioning wildly, a powerpoint, and a visual aid. The visual is a set of configurable pegboards to represent different filtration “pore” sizes, and demonstrate how effective they might be depending on the situation.

4th grade Oregon Trail unit on water filtration
Steeper slope=more water pressure. Bill Nye, whenever you’re ready to have me on…

I can’t post the ppt here because I’m certain I used a number of copyright images. However I was able to record the presentation this year, so I can make the audio available. It’s about 25 minutes long including the questions. But if you’re into this kind of thing, or want to learn about different water treatments, enjoy!

3 focus points when working with poor food safety culture

“It’s not like they won’t find something anyway”

“We don’t have time”

“It’s never going to be perfect”

“That’s not my job.”

“We’ve done it this way for years…it’s never caused a problem”

Anyone who has worked in food at restaurants, manufacturers, or at home has run into folks who don’t hold food safety as the first priority when making food. This is hard at every level, but gets exponentially worse when executives and managers aren’t on board.

Here are some recommendations to think about for folks who are working in quality roles everywhere. These are most relevant to a dedicated quality person (like a QA manager at a manufacturer), but could also be implemented by anyone who wants to make a dent in moving food safety up the priority list for your fellow staff.

1. Make sure you are respected first.

“Dude, you’ve been here one day. It’s fine.”

No one is going to take quality culture, preventative food safety, etc. seriously if they don’t take the person leading it seriously. This is true for personal safety, lean ideas, or any other culture change. Make sure you’re not on any kind of high horse (because I’m right!), and make contributions that are relevant and help the production staff and supervisors, rather than impose burdens. Examples could be streamlining quality checkpoints or finding opportunities that improve both production efficiency and food safety.

Recommend little, but ask the questions that lead in the direction of food safety.

“If the equipment was already clean and ready to go when the operators arrive, do you think we would start-up faster or run better?”

QA direction: dedicated sanitation personnel, less conflict at startup between production goals and pre-op QA”

“Would it be easier for them to hop back-and-forth if there’s a problem if there was more space?”

QA direction: De-clutter workspace to make auditing tools and sanitation easier/more effective.

“Would it be better if they didn’t have to stop to measure and write down all this stuff?”

QA direction: installation of dataloggers, sanitizer dilution pumps, alarm-based checks

Common QA mistake: When working in an environment where a “compliant” culture isn’t in place, don’t cite regulations to make your point. No one wants to make change because the government says so (especially if they aren’t enforcing it), and no one wants to do it to make your annual audit easier. As far as the staff is concerned, audits and inspections are your problem once a year and because it’s hard for you, you’d rather make it their problem every day. Demonstrate the need for change based on risk to products, people, and business.

2. Prioritize, and let it go

The beard snood not covering my mustache isn’t the food safety risk you should be correcting in this situation.

In tandem with #1, unless you have an obviously high-risk product that is susceptible to contamination from hair or loose threads in clothing, let some of that stuff go. We know all of the basic personnel practices are important, but things like sanitation, cross-contact, and temperature control are the big ones that you need to use your “good will” currency on.

Don’t spend all your patience and points on forcing bangs under hairnets, immediately breaking down that extra (clean) cardboard, etc. And if these things need to be addressed, find allies within your organization to help enforce the small stuff so it isn’t all coming from the “quality police”. Including other staff/departments to set a good example or encourage these smaller, non-critical changes can help you save up all of your points for the big stuff.

With limited resources and limited “buy-in” your hard-line stances need to be on items that make food safer, rather than making audits easier.

3. Data, data, data

“I’m just saying that the correlation is unsettling, and we should look into it.”

Start getting quantitative verification of how you’re doing as a company, examples could be: complaints, defective products, production paperwork errors, sensory failures, mispicks, # of rags left on the floor at the end of the day, disposal costs, time cost for equipment breakdowns, time cost for rework, etc.

Lack of quality culture is many times driven by a lack of observed cost-benefit. Without data, everyone flies by the seat of their pants and can dismiss your concerns with “It’s not that much product, we produce a ton of okay product”, “it just happens sometimes”, or “it wouldn’t be worth the extra time to fix it for how often it actually happens”. Half the time “new” quality issues don’t go away, we just get complacent with them. As a new employee you didn’t bring in any of that complacency with sub-par products or food safety risk, and you have to bust some chops with data.

Data also provides a tool to those people in the company who do want to support a quality culture, but haven’t had any compelling evidence to disagree with their peers.

There are a number of resources out there for working with immature food safety cultures, and even more for immature personnel safety cultures, many of the same principals apply. I’m a big fan of the ADKAR model for change.

Here’s a limited piece of what you can directly do as a quality officer to support an ADKAR mode:.

Awareness of the need for change: Data, data, data

Desire to participate and support the change: respect, focusing only on one problem at a time (I know, it’s hard when it feels like an imminent food safety threat)

Knowledge on how to change: Come with multiple solutions or a goal oriented request (What could we change that would get the dirty mop bucket out of the room during production?), demonstrate that changes work with: data, data, data

Ability to implement required skills and behaviors: Volunteer to train employees on new procedures, and change your quality program to make it easier. Maybe you can replace that chlorine titration kit for a rapid test method? Maybe you can make a checklist? A fast reading digital thermometer could replace that old dial thermometer and make it feel like less of a chore.

Reinforcement to sustain the change: Persistence is key on your ONE issue you’re fixing. You may have changed the procedure, but your quality items are just one instruction of hundreds every employee receives every day. Even your best coworkers will need to have the entire ADKAR explained more than once. Until they’re doing it without help for at least 60 days, you don’t get to move on to your next project. If you throw it out there, move onto the next shiny change and hope it will stick, it won’t.

Ultimately you’ll need to decide if your company can embrace and make the transition, because food safety is hard and it’s only harder if your efforts aren’t recognized as beneficial to the business (did I mention data?). Make sure you can do the job ethically and legally and see what change you can effect, but know your personal lines and be ready to walk away from a bad situation.

Some of my favorite resources for reaching personnel on food safety:

Stopfoodborneillness.org is a great resources for personal stories of the impact of foodborne illness on individuals. Their “Why of food safety” video is a great refresher to regain momentum.

Behavioral Based Food Safety is a great IFSQN webinar talking about why people choose not to do the right thing, and how to create targeted strategies to get them on board.

ADKAR model for change mentioned above.

Here’s an ROI template I made you can use to make cost driven changes to QA practices.

The above were some thoughts I had while helping out another member at the International Food Safety and Quality Network who was struggling with a new company that was missing “management commitment” to a culture of food safety. Let me know what you think, or if you’ve ever run into a fellow employee, restaurant owner, or anyone who didn’t appreciate food safety and how you worked with that person.

New recalls and outbreaks feed

On the site we now have a new page called food outbreaks and recalls, which is a simple aggregated feed of news releases from FDA, FSIS/USDA, and CDC for those interested in checking out what was just recalled day-to-day or what outbreaks are currently being investigated.

Sorry for the break in content. We’ve just completed the transition to wordpress.org, and the details of getting all the new tools etc. in place took up quite a bit of time that ate into my content-creation time.

Back to our regular schedule next week, I have a lot of exciting ideas for posts and data analysis, and have already crashed excel twice making it do more stats than it ever wanted to. Stay tuned!

Fur, Farm, and Fork awarded IFSQN Member of the Month

Me and the other person with the NPR donation mug can stare each other down now.

I’m proud to be awarded Member of the Month for March, 2017 over at the International Food Safety and Quality Network, a community of food professionals sharing knowledge about food safety, equipment, certifications, and support.

From their about page:

The IFSQN was founded in 2003 to provide food safety practitioners with an online platform for sharing knowledge and information and to enable collaboration on the effective implementation, operation and continual improvement of food safety management systems. Twelve years on this remains our primary goal. As food safety regulations continue to develop and third party food safety certification standards are mandated globally the importance of the IFSQN has never been greater.

The IFSQN website attracts well over 1,500 unique visitors every day and we also distribute the popular Food Safety Talk newsletter to over 25,000 subscribers each and every week.

Our discussion forums are unique and unrivaled anywhere in the world; with over 40,000 members creating an archive of over 80,000 posts as well as 1’000’s of files and documents to assist members old and new.

Each year we run the popular Food Safety Live online conference which brings together thousands of food safety practitioners for a free day of learning and in January 2015 we began running weekly complimentary educational webinars for our members.

If you work in food check it out, the forum archive has an amazing array of topics, and there are some very talented people on there helping out for free purely to help other manufacturers produce safe food. It’s like VIN for food professionals, and that’s pretty awesome.

I get a sweet new mug, courtesy of Safefood 360 ™ as my “trophy”. Will display proudly next to my “Where your hairnet” trophy.

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.