Not just “in bed with business”, 5 things FDA does for consumer advocacy and safety

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 two lists 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 discuss warning 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:

National Antimicrobial Resistance Monitoring System: ongoing evaluation of antibiotic resistance in retail meats and other commodities

Microbiological Surveillance Sampling: FY16 Cucumbers and Hot Peppers

Microbiological Surveillance Sampling: FY14-16 Raw Milk Cheese Aged 60 Days

Microbiological Surveillance Sampling: FY14-16 Sprouts

4. Pesticide Residue Monitoring Program

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!

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.