All of Oregon’s restaurant inspections soon to be online

Restaurant Complied sticker
Source: Multnomah County Food Safety Blog. Check it out, it’s awesome! http://www.chefsconnection.org/

Food safety is expensive, how do we reward companies that are taking the time to do it right?

It’s been shown that consumers will use food safety performance to choose which restaurants to eat at when it’s available. Unfortunately, when it isn’t available, a restaurant that is keeping your biscuits and gravy at a balmy 110ºf doesn’t look any different than the national brand that gets audited quarterly by their corporate food safety team armed with calibrated thermometers, a handwashing alarm, and zero tolerance.

As of this year, Oregon is working to make that information available to all of us carrying a smartphone.

The Oregon Health Authority has now enrolled34/36 of Oregon’s counties into the Healthspace software, a platform for them to scan, log, track, and make restaurant inspections publicly available.

To get more information I spoke with Jonathan Modie of OHA, he reported that the state is very excited about the new system, both from the increased level of transparency it provides to the public, but also the new analytics tools to help them identify problem facilities or locations. Having everyone on a single system allows for better data and helps counties compare their situations to each other.

So why do I have such a cluster of different sources below for restaurant inspections? It turns out the state made the system available approximately one year ago, which is allowing time to get every restaurant into the system both to troubleshoot, and level the playing field among restaurants. Rather than say “LOOK AT OUR NEW SYSTEM!” and encourage everyone in Oregon to look at the only inspection logged in the system so far (e.g. FF&F Fried Chicken), allowing a year for the backlog to include every restaurant in the county to be represented is both fair and prudent.

Just two counties are still operating outside the healthspace system but the inspection data is still available for consumer review. Multnomah and Washington counties already had robust public reporting systems in place, though Multnomah county intends to transition sometime later this year.

While it isn’t food safety directly on the door of the restaurant (which research tends to demonstrate is the only real way to have an impact on the general public and not just nerds like myself), it’s much more accessible than going to the bulletin board at your local courthouse. Public inspections allow us to not only hold restaurants accountable, but to assess the effectiveness of enforcement. We will be able to hold county inspectors responsible for visiting restaurants at the appropriate intervals, even if they’re far away.

So how does it work?

Oregon’s restaurants are inspected by local county environmental health officials, who try to visit twice annually but at least annually to ensure that restaurants are in compliance with Oregon’s sanitary standards. Restaurants are scored based on the severity of the various violations:

  • Priority: violations that are considered direct contributors to foodborne illness. These are the big ones like hot/cold holding and cooking to temp.
  • Priority foundation: violations that aren’t making dangerous food right now, but could contribute. Things like failing to make sure your sanitizer is at the correct concentration.
  • Code: findings that violate construction or other standards, but aren’t posing an imminent food safety hazard.

Restaurants that score above 70 are in compliance, however that score is not indicated on the door of the restaurant. Producers simply receive a “complied” or “failed to comply”. Not crazy helpful.

For today however, for those of you in counties already making this information public, you can click on the links below and check out the most recent inspection and/or score of the restaurant you plan to dine in (or a local favorite).

County Where to access online as of 1-15-18
Baker https://www.malheurco.org/environmental-health/online-inspections/
Benton Coming in 2018
Clackamas http://www.clackamas.us/publichealth/restaurant/
Clatsop https://healthspace.com/Clients/Oregon/Clatsop/Web.nsf/home.xsp
Columbia https://healthspace.com/Clients/Oregon/Columbia/Web.nsf/home.xsp
Coos Coming in 2018
Crook http://www.co.crook.or.us/Departments/HealthDepartment/EnvironmentalHealth/tabid/2183/Default.aspx
Curry https://healthspace.com/Clients/Oregon/curry/Web.nsf/home.xsp
Deschutes https://healthspace.com/Clients/Oregon/Deschutes/Web.nsf/home.xsp
Douglas Coming in 2018
Gilliam, Wasco, and Sherman http://ncphd.org/records-licensing/environmental-health-food/food-restaurants/
Grant Coming in 2018
Harney Coming in 2018
Hood River https://healthspace.com/Clients/Oregon/hoodriver/Web.nsf/home.xsp
Jackson https://healthspace.com/Clients/Oregon/jackson/Web.nsf/home.xsp
Jefferson Expected January 2018
Josephine https://www.co.josephine.or.us/Page.asp?NavID=1253
Klamath Coming in 2018
Lake Coming in 2018
Lane https://healthspace.com/Clients/Oregon/Lane/Web.nsf/home.xsp
Lincoln Coming in 2018
Linn Coming in 2018
Malheur https://www.malheurco.org/environmental-health/online-inspections/
Marion http://apps.co.marion.or.us/RIS/Default.aspx
Morrow https://healthspace.com/Clients/Oregon/Umatilla/Web.nsf/home.xsp
Multinomah https://aca.accela.com/multco/
Polk Coming in 2018
Tillamook http://tillamookchc.org/environmental-health/facility-inspections/by-type/restaurants/
Umatilla https://healthspace.com/Clients/Oregon/Umatilla/Web.nsf/home.xsp
Union http://www.chdinc.org/eh/
Wallowa Coming in 2018
Washington http://www.co.washington.or.us/HHS/EnvironmentalHealth/FoodSafety/restaurant-inspections.cfm
Wheeler Coming in 2018
Yamhill http://www.co.yamhill.or.us/content/yamhill-county-restaurant-inspections

I’ll revisit this list later in 2018 and update as additional counties come online. Happy researching, and a heartfelt Kudos to OHA for championing this initiative to make our food supply (and regulation) transparent. When the world doesn’t end for restaurants, Oregonians should push for similar transparency for retail and food processor inspections.

Oregon food processing establishment inspections, location impact on inspection backlog

ODA Food Safety Inspections
Each circle represents a city, larger circles indicate more inspections were performed in that city.

Oregon Department of Agriculture has had some recent poor reviews regarding it’s maintenance of inspections in recent years.

In December 2014 in response to a public records request from the Statesman Journal, they quickly worked to get caught up on several grocery store inspections before releasing the report.

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?

Distribution of months since last inspection

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.

Average months since last inspection city count

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).

City Average months since last inspection
Oakland 46.7
Elkton 35.9
Aurora 33.1
Cornelius 33.0
Monroe 30.3
Boring 28.2
Mt Angel 26.2
Dayton 26.1
Cloverdale 25.5
Gold Hill 24.0
Brookings 23.5
Gaston 23.2
Culver 22.9
Milton Freewater 22.6
Keizer 22.1
Phoenix 21.2
Rickreall 21.0
Yamhill 20.6
Dallas 20.5
And the best?
City Average months since last inspection
South Beach 3.2
Baker City 6.3
Lake 6.4
Gold Beach 6.8
White City 6.8
Cottage Grove 7.3
Enterprise 7.5
Oregon City 7.9
Gresham 8.2
Grants Pass 8.3
Mosier 8.9
Rogue River 8.9
Klamath Falls 9.0
Roseburg 9.5
Madras 9.7
Depoe Bay 9.9
Ontario 9.9
Redmond 10.3
Tigard 10.4

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.

ODA inspector offices and cities with >18 month average inspection
Stars are location of food safety inspector offices, blue circles are cities where the last inspection was >18 months ago on average

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.

ODA inspector offices cities average inspection <18 months.
Red stars are ODA food inspector offices, blue circles are cities with an average of <18 months since the last food safety inspection.

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.

Relevant literature:

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.

Filion, K. and Powell, D.A. 2011. Designing a national restaurant inspection disclosure system for New Zealand. Journal of Food Protection 74(11): 1869-1874
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Why I decide to care about food safety

Hospital Bed
Source: Wikipedia Commons image by tsca. https://commons.wikimedia.org/wiki/File:Hospital_room_ubt.jpeg

Oftentimes when we talk about the importance of food safety, we bring up victim cases; devastating accounts of individual families whose lives were forever changed by a horrific illness. Even more so, us in industry attend meetings and go to training that reinforces CDC’s “1 in 6” statistic, or the roughly 3,000 people that will die this year. We leave thinking “obviously this is a public health emergency” and that we can improve quality of life for everyone if we could simply give out more thermometers, convince people to stop eating raw oysters or milk, and have mandatory vaccinations and 100 days of sick leave under surveillance for food service workers…

…but where does this actually land in terms of risk? Where do we prioritize this as a public health initiative? 1 in 6 people includes an unpleasant day of diarrhea from unknown sources. And 128,000 people hospitalized…we could save that many people from injury or death simply by turning our attention to something with as much or more public health impact like defensive driving, combating alcoholism, or even trying to regulate safety in extreme sports.

Leading causes of death in 2015
CDC Mortality table 19: https://www.cdc.gov/nchs/data/hus/hus16.pdf#019

It’s a similar question you might ask when donating to your neighbor’s school band program. Couldn’t that money have been better spent at a food bank or doctors without borders? What about a political campaign that said it would support those band programs ongoing?

People end up choosing a path for many different reasons. Before I knew I would be doing what I do now, I wanted my career to have a positive impact on the world. What compels me to focus on food safety is how cruel and unfair so many of those illnesses are. Stop foodborne illness does an excellent job illustrating this point with their honor wall.

Choosing your lunch shouldn’t be a life-altering event. But it is for those 128,000.

While I, as a food industry person, tend to be empathetic to the restaurants and companies who then have to live with the horror of having caused such an event, so many more manufacturers continue to squeak by with “no reports of illness”, even as food rots on uncleaned equipment in their facility, ready for the next day’s production.

I approach my work every day with the thought “could I be contributing to that number somehow?” and make decisions through that lens. I’m lucky to work for a company that takes that responsibility seriously, but other food safety professionals aren’t as lucky. Those people have a decision to make, stay and try to make a difference, or move on to somewhere that’s already doing the right things and wash their hands of the situation. It’s hard to say which one is the right move. As some food safety podcasters like to say, it’s complicated and it depends.

I care about food safety because when I personally buy food it comes with a promise. Not just the same promise as any other product in that it meets my expectations, but the promise that whomever sold it to me would be appropriately upset if their product somehow hurt me. Not because my injury or death threatened their livelihood, but because they care about their fellow man and that they prepared the meal for me with the best of intentions. I care about food safety because it’s a small and tangible way that I can have a positive impact on the world, even if it’s just that we can choose to eat whatever we want with the knowledge that the risk is on us rather than a lottery born of willful negligence.

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!

FDA Warning Letters This Week 2/22/17

warning-letters

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

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

WL# 17-PHI-04

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

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

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

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

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

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

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

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

So back to the warning letter:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

pitted-concrete
Source: my patio.

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

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

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

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

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

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

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

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

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

That was sarcasm.

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

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

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

99.999% of 10,000,000=100

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

After all, in 2011, you said this:

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

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

Anatomy of a “Serving”

NFPIs it how much you’re expected to eat? How much you should eat? Pardon me, but if I want to eat an entire bag of potato chips, that’s exactly what I’m going to do.

I say this as the guy who helps create nutrition facts panels for food products for a living. I have read, reread, proof read, and colored red hundreds of these little tables in my time, and believe it or not, people aren’t lining up at parties to hear my thrilling stories.

I know!

Right now you’re thinking, “But Austin, I remember back in 2008 the FDA called 2,584 adults from the US to ask them questions about their diet. And 24% of the respondents said they had no idea if serving sizes were determined by government rules or by manufacturers.”

Your oddly specific observation would be correct, and I should have at least ¼ of the room hovering around me in rapt attention, waiting for me to clarify this confusing point. Time has shown however that everyone is clearly too intimidated to approach and ask the simple questions, even when I’m subtly firing off labeling trivia from the empty cracker box carelessly left by the cheese platter, or establishing my mastery of the dance floor.

Fact: Every party has a dance floor, here’s the label. dance floor Well let’s clear this up right now while I’ve got you at home/work/somewhere, on your computer/phone/tablet (scary that I know where you are, isn’t it?). Who determines serving sizes, manufacturers or the government?

Answer: The government!…ish.

Well that was unsatisfying, but it’s the most accurate answer I can give. Essentially what happens is that our government, via the FDA and FSIS (Food Safety Inspection Service), determine how serving sizes are to be calculated and presented, but also leave manufacturers options in specific situations.

So how are serving sizes determined?

Step 1, what are you eating?

he first step companies need to take when determining serving size is to determine what type of product they are selling. Back in 1993 when they had to decide all of this stuff, FDA determined that they could use data collected in the NHANES dietary surveys conducted in 1978 and 1988 to set these standards. These were nationwide surveys that collected all sorts of data, including nutritional intake and food frequency data. With this information, FDA created “Reference Amounts Customarily Consumed,” or RACC, for different categories of food.

The first step is easy, find the category that a food falls into, and look up the RACC used to determine the serving size in 21 CFR 101.12 (for non-meat items). For example, if I was making mashed potatoes, my category would be “Potatoes and Sweet Potatoes/Yams: Mashed, candied, stuffed, or with sauce” and my RACC would be 140 grams.

Step 2, how can someone measure it out?

Here’s where the variation begins! You might just want to use that 140 grams we saw above; however, not everyone has a scale in their kitchen, and let’s see you try to guess how much mashed potato makes up 140 grams. Can you think of the last time you weighed your food, much less with metric weights (provided you live in the U.S.)?

So at this juncture, the government instructs manufacturers to determine what the closest “common household measurement” to one RACC of your product is. So if we take 140g of our potatoes and see that that’s about 2/3 of a cup, our serving size becomes 2/3 of a cup!

>THIS IS IMPORTANT<

Imagine we made a new, super fluffy mashed potato with more butter, and 140 grams of these potatoes actually wind up closer to ¾ of a cup. This means that even though both potato products were based on a RACC of 140g, they might have two completely different serving sizes, and the manufacturer arrived at each using the same government reference amount!

So there you have it, two serving sizes created based on a government standard, but completely different once observed on the store shelf. How could there be even more variation?

Single Serving

Ah, right. For many products, if the entire container contains less or near 200% of the RACC amount, then there are different rules to play by. In most cases, the product will be considered a single serving, but in others, manufacturers have the choice to label them as one or two servings. This is why you see different types of labeling in small containers such as ice cream, muffins, soda, and other “single serving” containers that appear significantly larger than the usual RACC amount.

As eaten, not as sold

Ah, and this is critical. When you ask someone how much cake they eat, they typically don’t respond with, “about 1/3 of a box of cake mix”. RACC values are based on products as they are consumed. However, serving sizes are based on products as they are sold. The reasoning? Because it would be bizarre to buy a bag of flour and see “two slices of bread” for a serving size. This makes more sense for some products than others, but ultimately serving sizes for products that require further preparation are the amount of packaged product it takes to make about 1 RACC of product as eaten. And remember, this must be rounded off at a common household measure!

Final thoughts

As we realize that our beloved nutrition facts panel is now old enough to drink (enforcement began in ’94), we look back and start to wonder if that data from the 70’s and 80’s used to determine RACC values still holds water. I can’t think of anyone who eats ½ cup of ice cream in a sitting, nor leaves the potato chip bag untouched after their first 10-20 chips.

But how about we think about RACC values in a different way. These values were never intended to be an expectation, but simply a way to bring nutrition information into context using consumer data. The thousands of calories in a 20 lb. bag of rice don’t have a lot of context when I eat it one bowl at a time, but that’s also not to say that I’ll never eat an obscene amount of rice in one sitting just because I’m starving.

Instead think of it this way, if these values are simply references to what we customarily consume at a time, we’ve got a great tool on our hands. I wouldn’t expect you to eat only ½ cup of ice cream, but have you noticed that many ice cream scoops happen to portion about ½ cup of ice cream at a time? And while I’ve been known to turn a bag of kettle fried chips into a meal, I still eat them one handful at a time, which just so happens to contain approximately 10-15 chips.

If only some sort of reference was available so that I could tell about how many calories I ate with each handful…

To learn more about how serving sizes are determined for all food products, check out the labeling and nutrition documents on the FDA website, this PowerPoint provided by the FSIS, or the Guide to Federal Food Labeling Requirements for Meat, Poultry, and Egg Products. Check out what consumer opinions of labels are looking like since 2008 in the FDA’s consumer research.

Choinière C. & Lando A. (2008). 2008 Health and Diet Survey, DOI:

ResearchBlogging.org

Conrad J. Choinière, & Amy Lando (2008). 2008 Health and Diet Survey FDA Consumer Behavior Research Foos Safety Surveys (FSS)

Why isn’t the USDA declaring the invisible feces in our meat?

No, that wasn’t a typo. Today I came across this petition for rulemaking to FSIS from the Physicians Committee for Responsible Medicine.

First off: PCRM has some great programs that promote research, animal welfare, and better medicine. The overall merit of their organization cannot be judged by a single program or campaign they have in place.

Now let’s tear this petition apart, because I actually had to check their website to make sure it was real, and not an over-the-top satire from The Onion.

The concern the committee wishes to correct via this petition is thus:

“Inconsistent with its statutory mandate, USDA regularly passes at inspection meat and poultry that is  contaminated with feces. Although USDA implements a “zero tolerance” policy for fecal contamination, this policy applies to visible fecal contamination only. The result is that fecally contaminated meat and poultry products pass inspection as long as the feces on them are not “visible” to the naked eye.

This inspection policy conveys a misleading promise of “wholesomeness.” Feces may contain round worms, hair worms, tape worms, and leftover bits of whatever the animal excreting the feces may have eaten, not to mention the usual fecal components of digestive juices and various chemicals that the animal was in the process of excreting. Americans deserve fair notice that food products deemed “wholesome” by USDA would be deemed disgusting by the average consumer and adulterated under any reasonable reading of federal law.”

Not to quote without context, the petition goes on to list the ways in which non-obvious feces may be introduced to meat product, the most valid being shared scald/chill tanks in processing operations.

Ultimately, the corrections the committee is seeking are removal of the “wholesome” description from USDA inspected meats, begin treating feces as an adulterant, and:

“USDA should amend sections 317.2(l)(2) and 381.125(b)(2)(i) of the Code of Federal Regulations to exclude from the current mandatory label the sentence that reads, “This product was prepared from inspected and passed meat
and/or poultry.” USDA should amend sections 317.2(l)(2), 381.125(b)(2)(i), and 381.125(b)(2)(ii) of Title 9 to include in the mandatory label the following as the second-to-last sentence: “This product may be permeated with feces, which cooking does not remove.”

That’s some pretty heavy language, perfectly stated to play on the fears and squeamishness of your average consumer. However, I see nothing written there about food safety, so the intention of the change is obvious: prevent people from eating meat.

While the about page for PCRM mentions nothing about being proponents of animal rights, the amount of articles devoted to encouraging a purely vegan diet clearly shows that they have an anti-meat agenda. While they correctly advertize the health benefits of vegan foods, a quick search of their website saturates any visitor with the message “meat is bad, and animal agriculture is always cruel”.

The petition shines a light on a group that is ready to intentionally scare and mislead consumers into changing their lifestyle. As part of their justification that feces is everywhere, they cite one of their own studies, “Fecal Contamination in Retail Chicken Products“. In this study, the committee proved that invisible fecal contamination is everywhere by “testing for the presence of feces.”

No such test exists.

What they actually did was test for generic E. coli, which can act as an indicator organism for fecal contamination.  HACCP programs in slaughter facilities use on-line enumeration of E. coli and other coliforms to validate critical control points for just that purpose. But in this case, rather than setting limits and using a statistical rationale to make a conclusion about the level of contamination, it appears that any evidence of the presence of E. coli  led to the determination that the sample was contaminated with feces. Because there are no methods declared, this evidence could be as mundane as RNA fragments from a non-pathogenic strain recovered in an enriched sample.

The study is absolutely meaningless. There is no available data to review in terms of the levels of contamination, no methods listed for how the E. coli was enumerated, and finally no legitimate publication, suggesting that the construction of the study and its conclusions would not have passed peer review.

As part of the rule change, PCRM would like feces to be declared as an adulterant. Generally, USDA inspectors cannot allow adulterated products to enter commerce, adding to the ludicrosity of this proposal. By the PCRM’s definition, all meat products are covered in invisible feces, and the presence of invisible feces should prevent any product from entering commerce. In one swift move, PCRM will ensure that only clean, wholesome meats will be sold, i.e. none.
But have things changed over the years to make eating meat less safe? The PCRM thinks so. I have no data to argue whether or not Americans are cooking less (PCRM also neglected to provide data), and eating more RTE products, but I did think it was funny that when I read this:
“Americans today consume far more meat and poultry than ever before, thereby increasing their potential exposure to fecal contamination in these products”
When the first link I read on their website contained this graph…
http://www.pcrm.org/media/blog/nov2013/youre-in-good-company-with-a-vegan-thanksgiving
http://www.pcrm.org/media/blog/nov2013/youre-in-good-company-with-a-vegan-thanksgiving
Which is it PCRM? Whichever is more convenient for the ad campaign at the time?
(side note: if people indeed are eating out more in restaurants, that would mean they are eating at inspected restaurants where county health inspectors ensure adequate cooking temperatures, rather than at home where people rarely if ever have proper process control)
Finally, the idea that the USDA needs to declare the presence of invisible feces on every product that passes inspection makes no logical sense,  and does nothing but mislead the consumer, not only by implying that the product isn’t safe in general, but that fully cooking the product makes no difference. If it wasn’t obvious by now that this proposed rule change isn’t solely to earn points with vegans, look closely the wording. In order to turn consumers off meat, PCRM would risk undoing years of public education and trust in proper cooking temperatures.
Clearly I took this proposal too literally, but because FSIS will actually have to review the proposal, and PCRM wants to brag about how these changes might occur, I offer one last piece of evidence to support my view that this proposal belongs on a tabloid.
Proposed legends
…one of their proposed inspection marks literally contains a DO NOT EAT symbol.

ResearchBlogging.org

Physicians Committee for Responsible Medicine (2013). Re: Fecal Contamination of Poultry and Meat USDA Petition for Rulemaking

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The poultry microbiome, culture-based ecology continues to mislead us all

Shigella penetrating the intestinal wall. Source: cellimagelibrary.org

If the world was enriched and homogenized, we would actually have a very good idea of what the microbiological community within looks like. Fortunately, the world is much more complex than the miniature environments we culture in the lab, and high throughput sequencing (HTS) is allowing us to fully appreciate micro-biodiversity. As new information becomes available, many of our models for microbial communities continue to be challenged by the actual composition of species in natural environments.

In the world of food safety, we rely on these models to set policy on a regulatory level, and to set critical limits down at the production level. Which tests we run on what products depend directly on what organisms (that cause food borne illness or spoilage) are supposed to be found on that type of food. The authors of this study that came out in PLOS ONE this February examined the microbiome associated with poultry products from farm to fork (meaning from clucking chicken to packaged poultry product) using HTS rather than culture/enrichment methods. The results indicate that there is an unappreciated amount of diversity between different stages of the poultry production process, and that we may not acknowledge the presence of some organisms as much as we should.

In the study, samples were taken from multiple steps in the poultry production process: wet and dry litter, fecal samples, fluid from carcasses collected during the cooling process following slaughter, and fluid from raw retail poultry products (legs, wings, and breasts). Other than the retail portion, all of the samples collected were from the same batch of birds from start to finish. The available RNA from viable cells in each sample was amplified and identified as belonging to specific species using a combination of Illumina sequencing and database referencing (blastn and usearch).

From this pile of data, lists of organisms were compiled to compare the ecosystem profile for each point in production.

The numbers refer the the number of unique taxa found in each group

The authors were very surprised by the amount of diversity between the two litter samples (wet and dry) and the fecal sample. They expected to see very similar profiles, as all of the predicted microbes in those groups would be inoculated from contact with fecal material (young chicks have no inherited microflora, and are coprophagous); however, all of the groups’ microbial communities had very little in common. As shown above, of the hundreds of unique species identified, only 52 were actually found at every stage from farm to fork.

In evaluating food safety, several results are of concern. The first was that the authors found significant amounts of Shigella spp., which have traditionally not been associated with poultry products and may not be a part of many sanitation programs. The second is that in one of their dry litter samples, the authors found a large amount of C. jejuni. It’s presence was interesting as previous studies have found it difficult to cultivate C. jejuni onto dry litter, suggesting that it will not grow in that environment. This discovery further shows that our attempts to cultivate bacteria are not indicative of their behavior in “the wild”. There may be nutrient gradients or a symbiont in play that allows C. jejuni to grow; therefore the possible contamination of dry litter has to be acknowledged in that facility’s Campylobacter monitoring program.

The last point of interest I’ll discuss here is the large amount of unique species that were found in samples following slaughter. This suggests that these species did not come from the farm, but rather were introduced during slaughter and processing. Interestingly, among Campylobacter spp., there was little to no abundance of C. jejuni in the samples, but differing amounts of other Campylobacter spp. This is revealing, as we have been predisposed to expect C. jejuni to be present due to our use of selective media.

Let’s fully appreciate the amount of diversity found within the processing facility, the authors collected two post-processing samples labeled carcass rinse and carcass weep. The rinse was composed of fluid shaken off of the carcass following its removal from the chlorinated chill tanks, and the weep was the drippings from the same carcass 48 hours later. 2/3 of the unique species found the weep samples were not found in the rinse. The authors interpret this as being due to the fact that the sterilization of carcasses is not the goal of poultry processing, and provide the example that viable Salmonella can be recovered from carcasses even after they are sent through the standard antimicrobial processes. The goal is to reduce enumeration, not sterilization.

Finally, in examining the retail samples, we get what we expect. Similar organisms as the weep, with some new faces, presumably because they persisted through processing at undetectable levels, and slowly grew as the product was stored in refrigeration.

The authors conclude by examining some potential symbionts that would allow C. jejuni to persist, but ultimately say that due to the high number of environments C. jejuni can occupy, attempting to exclude it in a universal way will not be very effective.

So all in all, a thorough example of the misdirection we receive from culture bias, and a startling look at how, given enough incubation time, properly processed meat can still support a huge amount of microbial diversity, including many food borne pathogens.

Appreciate this diversity, and make sure you cook your chicken to temperature.

 

ResearchBlogging.org

Oakley BB, Morales CA, Line J, Berrang ME, Meinersmann RJ, Tillman GE, Wise MG, Siragusa GR, Hiett KL, & Seal BS (2013). The Poultry-Associated Microbiome: Network Analysis and Farm-to-Fork Characterizations. PloS one, 8 (2) PMID: 23468931

“Organizational silos,” and how they prevent effective zoonotic disease tracking

It appears that the agencies that we rely on to track disease outbreaks need to start tracking disease, not just their own jurisdiction.

An article in Sociology of Health and Illness piqued my interest this last week that reveals the amount of segregation different government agencies have when dealing with zoonotic disease. The understanding of the goals and connections between livestock, wildlife, and human health among these agencies are often apathetic at best, and antagonistic at worst.

The author of the article took it upon himself to interview several government agencies with different species and regional jurisdictions, and was able to reveal what he calls “organizational silos” that develop when the values and cultures of these different agencies prevent them from working with outside groups. When attempting to monitor emerging infectious disease (EID), identification of cross-species movement is critical to predicting and preventing pandemics. Unfortunately, while they may be able to acknowledge the geographical movement of EID’s, many organizations are blinded by their specific oversight of humans or animals.

Copied from the article: Diagram showing the crossover between domestic animals, wildlife, and human EID. Important emergence factors for each circle are listed on the outside.

There are many telling comments contained in his interviews, and I encourage you to read the article to get the whole scope of the problem, but I’ve chosen to list a few of my favorites here:

From the Director of Animal Health Division at a state Department of Agriculture:

“‘We got a positive [flu result] on one of our routine surveillance tests’ of a poultry farm, Spencer complained, and ‘we were required to contact the USDA right away because of the pandemic Asian strain’. Spencer added, ‘It seems a little silly because there was no clinical illness on the property, and the strain came back something pretty common…’ In Spencer’s eyes, it was ‘hard to justify’ reporting the flu strain to the USDA… These days, Spencer said he passes on information about disease events to the state DOH and leaves it to them to tell local health boards. ‘If somebody screws up’, he shrugged, ‘at least we can blame the [Department of Health]’.”

Not an uncommon perspective for many organizations, or even coworkers! Let’s hear from another director at the USDA Animal and Plant Health Inspection Service (APHIS):

 “Clinton argued that the ‘single biggest threat for disease’ comes from ‘wildlife intermingling with domestic livestock’. He told me, ‘You can’t control the birds’ and he rightly pointed out that ducks are flu incubators. If the bird flu – which Clinton called the top priority of his agency – becomes pandemic in humans, he told me, it will come from waterfowl.”

Interesting, I might argue that we have much more interaction with domestic fowl (can’t remember the last time I handled a wild duck) and that they therefore were the point of spreading, but let’s see what others had to say about this viewpoint.

“Nina Marano, a zoonotic disease expert at the CDC, told me that ‘most of the outbreaks have occurred through interaction with domestic poultry’. Another example: though poultry farmers singled out wild birds called cattle egrets as the source of a 2004 flu outbreak in California, the egrets tested negative – it turned out that contaminated egg containers circulating between farms were the culprit (McNeil 2004).”

Finally, one last example of how a zoonotic disease often isn’t treated as such by human health agencies. From a Director of the Infectious Disease Bureau of a city Public Health Commission:

“When I asked Sanders to describe a zoonose that she responded to, she mentioned a recent outbreak of salmonella…and she believed that the pathogen came from two live poultry markets in Chinatown. What I found telling was that, in Sanders’ lengthy discussion of this outbreak, she did not mention any communication with veterinary medicine agencies.While the Disease Bureau’s response to salmonella followed protocol, it did not turn to the Department of Agriculture, the USDA, or any other agencies involved in animal health for help or information. Nor did it share information with them.”

Clearly here the city health board considered this a food safety issue, but payed no attention to the implications of getting meat from an approved source (a domain which definitely belongs to the USDA or county health department), or the fact that other agriculture agencies may be interested in a salmonella outbreak. There are many other telling quotes within these interviews, and I again encourage you to check out the article.

The author of the study concludes that the only examples we get of harmonious collaboration are for those diseases which are in the public eye such as rabies and influenza (H5N1 and H1N1), though we still have lines drawn even when the public is asking for action (“‘we have enough H1N1 to worry about without worrying about turkeys’. He
concluded that turkey infection is ‘a Department of Agriculture issue’”). The most shining example of the failure to communicate by these institutions in the article was the outbreak of Bird Flu in the US.

The first human cases of H5N1 in the US were wrongly diagnosed with St. Louis encephalitis, resulting in the deaths of 3 patients. A veterinary pathologist at the Bronx zoo observed neurological symptoms in some of the zoo’s birds and suspected a link, however encephalitis would not have killed her birds. Both the CDC and local DOH would not accept new information from her, instead keeping the encephalitis diagnosis. She then sent specimens to a friend at an Army Medical Research Institute of Infectious Diseases, who revealed the etiology of the disease and I’m sure had a hilarious conversation with the CDC and DOH (could you please explain to us why this veterinarian is doing your job casually on the side, and doing it better?). By the time the CDC received/accepted this information, H5N1 was endemic in the area.

Nothing against the CDC, it’s a fantastic organization, but this highlights the closed lines of communication that exist between human and animal agencies the author discusses. In order to prevent the next EID crisis, rigorous epidemiology is critical. Refusing to acknowledge the importance of cross-species movement to the virulence and emergence of a disease that falls under your agency does not only prevent you from identifying the next source of infection, but leaves you with nothing but reactive measures catered to a epidemic that you refuse to fully appreciate.

ResearchBlogging.org

Jerolmack, C. (2012). Who’s worried about turkeys? How ‘organisational silos’ impede zoonotic disease surveillance Sociology of Health & Illness DOI: 10.1111/j.1467-9566.2012.01501.x