The backlog received a more formal review from the Secretary of State in 2016, where the extent of the backlog was further teased out, as well as a lack of review of metrics. Here were the highlights:
There were 2841 firms late for an inspection (out of ~12,000 total)
They identified that there is currently no proactive method to capture establishments that never reach out to ODA to get a license in the first place
They had no idea how long it had been since they visited their “overdue” firms
“…the program has not been keeping track of these data and is unable to say how many firms were past due a year ago or five years ago”
So I was curious, of the ones who haven’t been inspected recently, how long has it been? And with inspectors scattered around the state, are there any correlations to be drawn between locations?
A public records request from ODA on 12/29/17 and I had a PDF with every firm currently licensed in Oregon, their address, and date of last inspection. The number of firms (a few were removed from the dataset for incomplete/corrupted data from the transfer) represented was approximately 1600.
Kudos to Oregon for now being able to pull this data so quickly! It shows they fixed the problem of being able to tell when a firm became past due. However, has the state been using this new tool to catch up on firms that haven’t been visited in a while? Or are they still visiting the same facilities?
That’s still a lot of inspections that were more than 40 months ago…Lets break this down in a few ways.
The Best and Worst
Note: while medians may have been a more representative average for areas with lots of inspection data, in order to make sure I could compare all cities equally I opted to use averages.
Averaging months since last inspection by city, we can see that the vast majority of cities are hitting less than 2 years as an average.
This is good, overall for the most part ODA is making sure that the majority of facilities are inspected at least every other year. The statewide average time since last inspection was 13.9 months.
So what cities were the worst at backlogged inspections?
(only cities with 3 or more facilities represented here).
Average months since last inspection
And the best?
Average months since last inspection
Unfortunately this doesn’t tell us much except that because the spread is so large, some areas must get more attention than others. To explore this, I charted out the office/assignment locations of all of ODA’s food safety inspectors in Oregon, then charted cities who averaged >18 months between inspections.
As I guessed there were some rural locations that may be overrepresented by having few facilities, but this data didn’t really look telling until I charted the opposite.
Given that every single ODA office fell within one of the high-performing cities, it appears that there is a correlation between general proximity to an ODA inspector and a higher likelihood of staying off of the inspection “backlog.”
This makes sense, as ODA inspectors see these facilities in their hometowns every day, they stay in their minds, and any changes in the business may make it their way via local coverage/discussion. They’re also simpler (low travel time) targets for inspectors who want to knock out multiple inspections in a day, should numbers be a factor or they’re being encouraged to make the most of their time.
This also demonstrates that ODA’s system isn’t currently setup (as indicated in the secretary of state report) to push inspectors to inspect facilities at their assigned interval or by “most overdue”. Instead the system permits discretion that leads to this distribution, ultimately creating areas that fall way behind the state average, and areas where some firms are inspected like clockwork regardless of their associated risk or past performance.
A more fascinating analysis would necessarily include a review of which facilities have problems and whether that encourages or discourages a more recent inspection, and the intervals between inspections for each firm. Unfortunately, I did not have the necessary data to perform that analysis.
To tackle the backlog, ODA responded to the report and released statements that they plan to take on fewer FDA contract inspections (which were represented in this report) in order to catch up the backlog. Given the large number of over-performing cities, it also seems that a backlog-driven inspection schedule could also assist the state in getting caught up by reassigning labor away from inspector’s backyards and towards rural Oregon. That would take care of the long tail anyway.
It’s complicated though. FDA inspections can take the place of state inspections while also providing a valuable source of revenue, something ODA has been requesting since 2014 to keep up with Oregon’s rapidly expanding food, beer, and now cannabis industries. FDA inspections are also much more timely and will continue to become more intensive as FSMA rules come under enforcement for smaller and smaller firms.
Ultimately, I don’t think this data demonstrates any particular failure on ODA’s part; however, it does show that there’s potential for unequal enforcement in rural areas. Making this information public allows us to understand the amount of food safety education and enforcement makes it to our communities, while also holding our state government accountable for getting them done. We want people to pay for food safety, both in taxes and business investment, that means they need to see the results of that investment.
I’m not done with this data just yet! If you have any ideas as to how it should be analyzed let me know and I’ll see if it can be teased out, or you can email me and I’m happy to share the source data.
Filion, Katie, and Douglas A. Powell. “The use of restaurant inspection disclosure systems as a means of communicating food safety information.” Journal of Foodservice 20.6 (2009): 287-297.
This week I’m going to do something a little different, rather than review the entire contents of one or several letters, I wanted to address some common findings that showed up in some truly awful facilities that received warning letters recently. Among a huge number of general findings of insanitary conditions like dirty equipment, rotting food, and poor general upkeep, the FDA inspectors made some pointed comments about hand contact when gloves were used.
Subject: CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
You failed to ensure all personnel working in direct contact with food, food contact surfaces, and food packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food as required by 21 CFR Part 110.10(b). For example:
a. Employees failed to maintain gloves used in food handling in an intact, clean, and sanitary condition as required by 21 CFR Part 110.10(b)(5). For example, an employee in the front kitchen was observed using gloved hands to assemble sanitized production equipment. This employee stopped assembly to manipulate the hose that had been on the floor and then resumed assembling the sanitized equipment without first washing and sanitizing or changing the gloves.
b. Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated as required by 21 CFR Part 110.10(b)(3). For example:
i. Multiple employees were observed returning from breaks without washing their hands or washed their hands and then put on hairnets and earphones, without first re-washing their hands, before resuming production activities in the front and back kitchens and the spice room.
ii. Throughout the inspection the front and back kitchen mixer employees were observed touching non-food contact surfaces such as shovels, buttons, equipment, buckets, cardboard boxes, waste bins, drums, kettles, and tables with gloved hands, then using the same gloved hands, without first sanitizing or changing, to handle raw ingredients and subsequently handle finished product and food contact surfaces.
iii. A production employee was observed after a break in production to come directly from the break area into the spice room, handle non-food contact surfaces including a door handle, tables, a screw driver and then handle food production equipment such as a mixer, paddle, and a hose without first washing or sanitizing their hands.
iv. Employees were observed entering the front kitchen production room from the spice room, handling non-food contact equipment such as a radio, boxes, and a trash can and then not washing or sanitizing their hands before performing work that included their bare hands touching the interior of “(b)(4)” finished product containers.
Subject: CGMP Food/Prepared, Packed or Held Under Insanitary conditions/adulterated
Employees were not observed washing their hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Specifically…Employees engaged in food preparation were observed leaving the food preparation area, retrieving additional ingredients or packaging supplies, and taking phone calls. The employees were observed changing their gloves between these events, but they were not observed washing their hands prior to changing their gloves.
So what risk do the findings pose?
So….here’s the deal. Hands are obvious and effective vectors for disease. In general we tend to focus on the fecal-oral route (fingernails and cheap toilet paper kill people, wash up friends), but in a food plant, it’s important to watch where employees frequently interact with areas where they might touch “unclean” spaces and bring things back to the product, like bacteria on a dirty pallet or allergens from a snack/lunch while on break.
What’s missing here to evaluate the risk is some context. Generally employees can move from sanitary “food contact” surfaces without having to “intervene” on their hands, and some of the surfaces identified such as equipment buttons or screwdrivers could very well have been sanitized at the beginning of the shift so that clean-handed employees could use them without issue. That would be an efficient approach to startup sanitation. However, the other findings like coming back from break or handling items on the floor or obviously dirty equipment is normally out of the realm of best practice, and based on the awful sanitary state of the plants mentioned in the warning letters, it’s very likely that those surfaces/practices resulted in frequent cross-contamination. Good auditor.
What about the gloves?
This is more interesting, FDA specifically went after both manufacturers for using dirty gloved hands, because gloves aren’t magical. However, in the second warning letter above, FDA was pretty strict in that they didn’t consider the glove change adequate as an intervention. The general thought process here is that if you take off a pair of dirty gloves, your hands get dirty in the process. Therefore putting on a new pair of gloves with “dirty” hands means that your new gloves get contaminated regardless.
The “gloves or no gloves” debate typically focuses on the fact that it has been shown that glove use actually reduces hand washing compliance in healthcare and food settings, because people think the gloves make their hands cleaner. While dirty hands get washed (eew, there’s dirt on my hand), dirty gloves get worn.
The other half of the risk assessment though is based on bacterial transfer rates. And on this half, it has been shown that bacteria transfers from food to bare hands at about a 10% rate while through a glove it only transfers at a 0.01% rate. So even if you contaminated your hands while taking off an old pair of dirty gloves, only a tiny amount of those bacteria would actually make it back through a new pair of gloves. Though that doesn’t matter if you then contaminate the contact side of a new pair of gloves with your dirty hands, and it has been shown that handwashing between glove changes reduces that incidence! BUT it turns out that surgeons do this to protect themselves from getting contaminated during surgery without handwashing when changing gloves aseptically, so it’s common practice in other aseptic fields!
So…it’s complicated. But there is a potential third option, even if it isn’t generally considered in the guidance (by the way, mandatory washing between glove changes isn’t actually codified anywhere, but is enforced guidance and part of GFSI schemes).
So we’ve concluded that putting on gloves with dirty hands results in dirty gloves. Fine. But once you’ve put on a smooth, impervious, surface that can be cleaned and sanitized, you no longer have a glove, but a “food contact surface” just like a spoon! And spoons (if visibly clean) can be sanitized before returning to use.
We know that, in general, current handwashing recommendations can result in a 2-3.5 log reduction of bacteria on hands. This is the best we can realistically hope to do with current practice, and we rely on handwashing to prevent either low levels of contamination, or to simply remove visible filth that carries higher numbers of bacteria. Further transfer to food depends on transfer rates that are highly variable, and actual food safety risk depends on what’s transferred and whether it has the ability to keep proliferating.
We also know that gloves can be removed with minimal transfer per medical literature, and that only 0.01% of bacteria will make it from a “dirty” hand through the glove. So we just need to take care of those pesky bacteria on the outside of the glove. Too bad there isn’t some kind of way we could quickly treat a visibly clean food contact surface…say a 5-log reduction in like, 30 seconds to a minute…
Enter glove/hand dips. A method where in critical areas you maintain a “bath” of sanitizer prepared to manufacturers specifications that will provide a 5 log reduction of pathogens on a clean surface. By changing your gloves and sanitizing them by dipping them in your solution, you can empiracally achieve a much higher reduction in organisms on the contact surface than you would achieve by de-gloving>handwashing>re-gloving. Even better, you can do it just as quickly has a hand wash and can put these hand dips in convenient locations. Basically, you treat your hands as if they were a utensil like a spoon instead of hands.
Hand dip stations are important to sanitize clean handsand gloves.
Important language distinction here is that they said “clean gloves”, they still need to meet a visibly clean standard for the sanitizer to work, but if there is no visible contamination, you’re ready to sanitize, and a fresh pair of gloves out of the box will normally meet this standard.
So, from a scientifically validated approach, glove dip stations should be as or more efficient as handwashing between glove changes. Unfortunately because of the abundance of state and FDA guidance mandating a “wash” between glove changes, different auditors may be more or less open to this procedure even if it has been properly validated/verified. However, the entire point of HACCP or HARPC is that you can establish whatever procedures work best for your plant/process that can be substantiated scientifically. Try it out, collect enough data to demonstrate that it works, and slip this blog post in your citations if it helps ;).
Fuller, Christopher, et al. ““The dirty hand in the latex glove”: a study of hand hygiene compliance when gloves are worn.” Infection Control & Hospital Epidemiology 32.12 (2011): 1194-1199.
Montville, Rebecca, Yuhuan Chen, and Donald W. Schaffner. “Glove barriers to bacterial cross-contamination between hands to food.” Journal of Food Protection 64.6 (2001): 845-849.
Robinson, Andrew L., et al. “Adequate Hand Washing and Glove Use Are Necessary To Reduce Cross-Contamination from Hands with High Bacterial Loads.” Journal of food protection 79.2 (2016): 304-308.
Jensen, Dane A., et al. “Quantifying the Effects of Water Temperature, Soap Volume, Lather Time, and Antimicrobial Soap as Variables in the Removal of Escherichia coli ATCC 11229 from Hands.” Journal of Food Protection 80.6 (2017): 1022-1031.
At FF&F, I’m often harsh on FDA for lack of enforcement, ownership of their own role in preventive food safety, and failing to consistently stand by their guidance. However, you will still see me using FDA research and policy decisions as a primary source of credible primary source material. After all, it’s right there in the agency’s mission:
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
This is a huge endeavor, and for all my criticism, threading the line between public health, consumer advocacy, and some portion of business advocacy is an incredibly hard task that they do what they can with.
Unfortunately, because tackling this mission requires individuals with knowledge of food as an industry, and because the agency is part of the federal government, many people do not recognize any scientific information provided by FDA either because they believe they’re part of a grand conspiracy (which is a group I don’t expect to be reached by this post), or because so many senior members are inevitably connected to conflicts of interest from the business side of food.
However, of FDA’s 14,000+ employees, many of them are doctors, scientists, and public servants who believe in the mission and perhaps even more compelling, there are many others who just have a “steady job” who don’t have a stake in the results. These folks produce great work that helps make our food supply safer. Work that is rigorous, effective, and from a market standpoint, impartial.
So I’ve generated this list to identify a few things to counter the “FDA isn’t an advocate for consumers” argument. To make it onto this list the items need to meet three criteria. First, that the actions taken are intended to protect the public or provide transparency; second, that the action taken doesn’t provide some obvious benefit or perk to industry; and third, that the action is transparent and verifiable (unlike an outbreak response or inspection/approval activities).
1. Interstate Milk and Shellfish Shipper Certification and List
These twolists are published monthly to the public. The list of milk shippers not only provides the names of approved shippers, but also approved manufacturers of packaging for milk in accordance with the Pasteurized Milk Ordinance. Even moreso, FDA publishes the current scores they received on their last sanitation audit so that consumers can hold companies accountable and make decisions based on food safety, or ask their favorite dairy product brands who they use. Public scores not only help consumers evaluate companies who otherwise wouldn’t share them, but they actively benefit consumers by incentivizing companies into trying for higher scores even though they technically “passed”.
2. Public posting of Warning Letters
We discusswarning letters often at FF&F because they offer great insight into events where FDA has actually moved forward with enforcement for violations of the law. For the public though, it’s a rare opportunity where FDA has taken the worst-of-the-worst offenders and laid their failures out for all to see, and even more so, note their lack of response when given a first opportunity to correct them.
FDA sees warning letters as a method for encouraging voluntary action to correct problems they found in investigations, after-market product testing and label review, plant inspections, and to increase the pressure on companies that aren’t responding to form 483 findings (inspection violations).
Warning letters are all public for companies big and small, and outline the specifics of the violations along with how they relate to the written law. They also remain posted online forever, even after the problems have been corrected, giving the public a direct look at who in the industry has been most negligent in adhering to the law.
3. Retail Surveillance for Foodborne Pathogens
FDA does a ton of microbiological surveillance activities to get data on the prevalence of foodborne pathogens at the retail level. Whether to evaluate the safety of a specific commodity or to check domestic vs. imported items, this data is not only valuable to consumers and industry alike, but also results in enforcement actions taken against those companies that have their products turn up positive (though unfortunately without some detective work it’s difficult to to see that follow up). Here are some examples of recent retail surveillance activities turned into reports for the public:
Each year, FDA samples thousands of produce samples both domestic and imported and tests them for hundreds of different pesticides to see what commodities coming from where are in violation of established limits or even detectable. They conduct targeted checks of commodities of concern and take enforcement action against violators.
Once the tests are complete, every year FDA produces a report to show what the current rates of violation and detected levels are. This allows consumers who are concerned about pesticides to either choose imported vs. domestic produce, or avoid certain fruits and vegetables that may be known for more violations. Consumers who are also buying Organic can check out pesticide levels/usage in conventional foods to make sure that their chosen commodity is worth the extra certification for their pesticide concerns.
5. Posting of Recalls, Withdrawals, and Safety Alerts
One that most people know about, but we often take for granted. Think about what a recall is: a company identifies (or has FDA identify for them) an issue with a product that makes it either illegal to sell or potentially unsafe to sell to the public, so the company pulls it from the market. Who needs to be made aware that this happened?
Obviously anyone selling the product needs to know to pull it from the shelf, and they need to let their customers know that they should throw it away or bring it back to the store. But does the entire country need to know that the local supermarket is recalling their muffins because they forgot to label the walnuts?
Not only does FDA make sure that the entire country knows when a company has a recall, but why they had the recall. They then keep a permanent public record that anyone who ever wants to buy a product or do any business with that company can look up with a simple google search.
In addition to publicizing these events, FDA uses this same forum to call out companies who don’t recall things voluntarily by issuing safety alerts and advisories. In the face of defiant companies who aren’t willing to “voluntarily” recall, FDA uses the forum to make sure the public knows both of the potential danger, and that the company isn’t allowed to keep the issue a secret.
There are a thousand other ways that FDA helps protect the public through policy-making, data collection, or enforcement, but these 5 are unique in that they’re immediately verifiable by anyone with access to a search engine, and that “big industry” doesn’t benefit by them unless they’re also advocating for the public. If anyone has anything else they think should be added to this list, please comment and I’d be happy to review and add it in!
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 getveryfewexamples 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.
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.
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.
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”.
Food safety issues are non negotiable. Label content must NEVER put a consumer at risk.
Has this issue been enforced based on the evidence available in warning letters or class action lawsuits?
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.
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?
Is your decision defensible within the “must/shall” of the CFR?
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.
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.
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.
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
Wood + 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.
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-zerolegal 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.
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.
I 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.
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
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
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?
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.
I’m back! Check out the About page for more information on the new direction of the blog. Today’s post will be a recurring one. Each week I’ll go through the FDA warning letters recently posted, read through the ones related to food, and offer a summary of any interesting findings and/or findings that we as consumers should or shouldn’t be paying attention to.
First, because this blog is about education and communication, let’s help out those who don’t know what an FDA warning letter is. Per FDA:
When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter.
The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate.
This is a good description of what a warning letter is, but when does FDA hand them out?
FDA sees warning letters as a method for encouraging voluntary action to correct problems they found in investigations, after-market product testing and label review, plant inspections, and to increase the pressure on companies that aren’t responding to form 483 findings (inspection violations).
In FDA-speak this means that they’re avoiding forced action that would be supported by a judge or federal officer, such as injunctions or seizing products and facilities. However as far as any reputable food company is concerned, it’s really being voluntold. After all, companies that do not respond to warning letters are almost guaranteed to subsequently receive actual enforcement actions, and because warning letters are public, if a company is in the public space in any large way (e.g. a recognizable brand) getting your warning letter closed is an additional public step to regaining consumer trust.
This is just a brief overview, for more information on FDA decision-making in regards to why a warning letter might be issued you can read their procedures. It also contains a lot of information about “prior notice” and other legal requirements the warning letter satisfies.
FDA warning letters this week
Now let’s get to the goods! In these posts I’ll be using the warning letter numbers to identify specific letters and avoid typing company names simply for the sake of making it about the information in the letter and not the addressee. If you’re curious about which companies received the letters, you can check them out yourself or google the warning letter number, that should get you there.
I picked a doozy of a week to start doing this, there are some extensive and complex letters here, I’ll keep my comments “brief”, but check out the letters for yourself to read the full scope of violations.
Subject: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Seafood shows up a lot in warning letters for HACCP violations. Companies and 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 warning letter is actually a follow up to a previous one, where FDA reviewed the corrective actions of the company and determined that they weren’t enough.
We received your written response dated January 10, 2017 which included Product Specifications and Importer Written Verification Procedures…However, your product specifications failed to identify the hazards that are specific to the product.
Off the top of my head, I would guess that the person who wrote the specifications in response to the letter has not had formal HACCP training and didn’t understand how to carry out an actual hazard analysis, or where the information could be found in the CFR. Ultimately this warning letter represents a failure of a company both to follow prescribed regulations and understand the value of HACCP and Preventative Food Safety.
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!
Subject: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
I love seeing this subject on warning letters, because it usually means we get some insight into how FDA enforces current good manufacturing practices (cGMP or GMP). Other times, we just get to hear about gross conditions within a plant. It’s really a mixed bag of findings, but they’re usually interesting in one way or another.
The first set of findings for this letter concerned inspectors finding flies, bugs, and rodent excreta pellets (REP’s, and one of my favorite acronyms ever) in the bakery. Thankfully, the REP’s were found underneath a mop sink in the corner, and not somewhere closer to food (some warning letters are much more nauseating with respect to where they find these things). The flies were found throughout the facility, both on products and equipment as flies in your home would. Not a good start. I imagine this facility has either no pest control program or doesn’t use a professional. Either way the presence of the flies indicates that their presence was “normal” and that this facility needs culture change. Further demonstrated by FDA noting that they found pests in inspections for two previous years (clearly no lesson was learned).
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.
The second set of findings concerned handwashing practices. These weren’t the worst ones you see. The ones that are immediately concerning are when FDA notes things like employees using the restroom or dirty surfaces like pest traps and mop buckets, then going back to touching products. In this plant the inspector took note every time an employee left the area or touched non-food surfaces and returned to food without stopping to wash their hands. This is wrong, and the company again has a culture issue, but remember that doctors only follow proper handwashing 40% percent of the time as well. So while it’s the wrong behavior for handling food, it’s far from abnormal and a constant struggle in all settings.
Additional findings concerned sanitation and handling of food contact surfaces. And…well, these some things that directly inoculate your products with bacteria.
packaging material…was observed in direct contact with the floor soiled with food debris
The baking sheet pans came into direct contact with a trash can during scraping. The sheet pans were not cleaned or sanitized after contact with the trash can before unbaked 9” pie shells were placed onto the sheet pans.
observations [of accumulated food debris on equipment] were noted after the previous day’s production run and prior to production start-up on each of the aforementioned dates. Production commenced without removal of the observed food debris.
The rest of the findings show pretty severe deficiencies with the way the company conducts itself, handles products and materials in the facilities (including storing secondary packaging in the employee bathroom…) and in general fails to maintain a sanitary facility for food production. Honestly this warning letter is so chock full of obvious contamination issues it’s frustrating that FDA hasn’t taken action sooner. After all, more than half of the observations are followed by the note:
This is a repeat observation from the 9/20/2010 FDA inspection.
This is where I get frustrated as a member of the industry, a taxpayer, and a consumer. According to FDA’s database of inspections, they’ve visited this facility on the following dates: 4/14/09, 9/23/10, and 6/10/11. According to the database, that’s the last time they’ve been there until the inspection noted in this warning letter (10/18/16). They were also never issued a warning letter for those inspections in 2011. Either they decided the State of TN was in charge of following up at the state level, they contracted FDA inspections through the state of TN in the intervening 5 years, or no one inspected this facility for 5 years after finding all these problems in 2011.
We won’t ever know, but regardless of what happened in the intervening 5 years, we should be grateful FDA is taking action now, and found the facilities response to a 483 issued at the inspection:
…[we] have determined your response is inadequate. You have not provided evidence such as photographs, receipts, and/or training documentation to show you have corrected any of the violations observed.
Here’s hoping some pretty good evidence was provided in 2011.
Subject: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
This letter is for similar violations as the first one we discussed for failing to adhere to seafood HACCP regulations. However this producer actually has a properly constructed hazard analysis and HACCP plan, but failed to properly execute it.
The firm had a cook step for crab that included a time/temperature combination to ensure that any pathogens would be killed. By reviewing the companies records, FDA observed that 9 different times employees had ended the cooks too early but no notes or corrections were made. This is concerning because it means that product may have been released undercooked, and employees running the equipment didn’t have the training necessary to follow the cook instructions, or understand why ending it prematurely was unacceptable.
The letter indicates that the company and FDA have been working through this issue, FDA indicates that the response has been inadequate for lack of evidence. Protip: if you tell FDA “we modified our HACCP plan to your recommendations”, you have to send them the modified HACCP plan. It’s amazing how many follow-up letters have to tell companies this or similar.
This facility also had sanitation issues, not as severe as the bakery above, but running on dirty equipment undermines any HACCP plan or cooking step you do.
You are not monitoring the cleanliness of food contact surfaces as evidenced by previously cooked crab parts from operations on the previous day and after cleaning operations were observed on the metal conveyor were observed to come into direct contact with newly cooked crabs on the conveyor belt.
Protip: if there’s still pieces of the food from the last time you used it, it isn’t clean.
Among the sanitation violations however, FDA notes that the correction actions the company informed them of are acceptable enough that they will verify at next inspection, rather than simply reply that “response was not adequate”, which is a good sign that FDA has confidence the company will get it together and can be trusted to keep improving without direct supervision. From the letter I get the impression that the company had problems, but didn’t have the longstanding culture and facility issues we saw manifesting in the bakery discussed earlier. After all, they couldn’t demonstrate that the low concentration of chlorine in their sanitizing stations was such a pervasive problem without also noting that employees were actually using the sanitizer stations frequently.
WL# CMS Case # 516352
Subject: Acidified Foods/Prepared Packed or Held Under Insanitary Conditions
Acidified foods are foods in hermetically sealed (airtight) containers that could support the growth of microorganisms (high water activity), but are modified with acidic ingredients to bring their final pH to 4.6 or below. FDA strictly regulates these foods because they have the potential to support the growth of Clostridium botulinumwhich causes botulism, a truly terrifying disease.
Because of these strict regulations, we often see warning letters related to not following HACCP/regulatory requirements for acidified or low-acid foods, very similarly to those we see for juice and seafood. This producer had a lot of issues that come down to them not following these regulations and controlling the process of production, leading FDA to crack down because they present a risk of growing Clostridium species in their products. Check out the letter for those specifics.
In addition to the acidified foods violations, the firm had some interesting violations connected to glove use. Nitrile gloves are often associated with food safety, but they aren’t magic. A clean hand is better than a dirty glove, and this firm demonstrated this with a few well observed glove observations:
an employee…had a tear on the glove worn on his right hand. The tear extended from the palm to the backside on the hand across the area between the thumb and fore finger.
an employee…was observed picking up a lid which had fallen to the floor and placing it in a sink. The employee did not wash or sanitize his gloves before returning to capping the filled jars of product
The only food safety “magic” that gloves provide is that they can be changed. A glove change and sanitize can save time and provide convenience to employees who do things like pick up objects they dropped on the floor or open doors when they don’t have to walk away to a handwashing sink. Provided that the gloves themselves are also in a convenient nearby location.
And when it comes to enforcing food safety behaviors, convenience=compliance.
I was perusing the Bad Bug Book while doing some research on the recent Blue Bell outbreak and came across a hyperlink. After hearing “do you want to know more?” in my head, I clicked through on some non-L. mono species of Listeria and was…confused. I quickly doubled back, thinking that maybe I had been redirected, but there it was.
FDA describes the reference as “current information about the major known agents that cause foodborne illness.” Descriptions also include a statement that it should not be used as a comprehensive or clinical reference. However, this isn’t an excuse for making a consumer and industry reference link to a completely uncontrolled document source. The Bad Bug Book (2nd ed.) is a wonderfully written resource, both for a lay and industry audience; but the fact that the authors of the Listeria page referred to Wikipedia as an ongoing resource, without knowing or being able to control the content presented to consumers, is irresponsible. A nefarious Wikipedia troll could at any moment have an article claiming that L. grayi is a GMO herbicide borne bacteria found in bananas that causes uncontrolled crying and hair growth, and have the full support of the FDA behind their article.
Please don’t write that article.
A currently live example of why this was such a poor decision is that if you click through to some of the pages, they don’t exist (as of 7/27/15). I don’t know if the author intended to write them him/herself and never got around to it, or if they simply assumed the pages existed, and then didn’t bother to review the content. I’m not satisfied with either of those answers, and if alternatively the reference articles were removed at some point, that also highlights what a poor decision those links were.
Given the sheer number of PhD’s involved in the book’s creation, I think taxpayers should expect a resource with material actually reviewed and sanctioned by FDA. The poor editing here is unacceptable and a change should be made to the current edition of the book.
Many of the other pages in the book name multiple related species, but either included links to NIH or CDC or included no link at all, both of which are acceptable alternatives. I won’t name the authors and editors of the book here, anyone who wants to know can find them at the front of the document. If you’re interested in bringing this to FDA’s attention in your own way, they’re on twitter as @US_FDA and additional points of contact are available at www.fda.gov.
Food and Drug Administration (2012). Listeria Monocytogenes Bad Bug Book, Foodborne pathogenic microorganisms and natural toxins. Second Edition, 99-100