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
.

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.

Eliminating Listeria in your Facility…the musical

Listeria monocytogenes on oxford agar
L. monocytogenes on Oxford Agar. Source: wikipedia commons author Nathan Reading

So I know that all of you who subscribe to Fur, Farm, and Fork do so for the meticulously researched analysis of food safety and regulatory issues.

So… here’s a Rihanna song parody about eliminating Listeria from a food plant!

…it was fun. And this is my site so I can do what I want.

If you want to listen to someone  sing it, download the mp3 here.

Lyrics below, basically covering where Listeria can be found in the food plant enjoy!

 Listeria (Disturbia Parody)

Bum Bum bio bum bum bio-film

Bum Bum bio bum bum bio-film

Bum Bum bio bum bum bio-film

Bum Bum bio bum bum bio-film

 

[what did we find

I didn’t expect this

What are we gonna do now]

 

What do these results mean

(presumptive positive)

Near the wall, near the sink

(where there was standing water)

Right where we process cream

(and products ready-to-eat)

Get the QA team together

 

It’s a sneaky microbe

Riding on your shoes

It can grow in the cold

Where it eludes you

A poison in your food

And it can end you

It’s too close for comfort

 

Let’s tear this room apart

We need to swab every square foot

Then the spare parts

We can get to the cause root

Use those trending charts

Why didn’t we catch this last year

It’s not in the product, we swear

 

But we just found Listeria

All the product’s been retained

Listeria

Biofilms in our drains

Listeria

Might be from the supply chain

Listeria

Listeria

 

Bum Bum bio bum bum bio-film

Bum Bum bio bum bum bio-film

Bum Bum bio bum bum bio-film

Bum Bum bio bum bum bio-film

 

Condensate drips from the walls

(we can’t see from where it comes)

These concrete cracks aren’t that small

(The floors are twenty years old)

We need some new grout

Old equipment thrown out

It’s too close for comfort

 

It’s a sneaky microbe

Riding on your shoes

It can grow in the cold

Where it eludes you

A poison in your food

And it can end you

It could be anywhere

 

Let’s tear this room apart

We need to swab every square foot

Then the spare parts

We can get to the cause root

Use those trending charts

Why didn’t we catch this last year

It’s not in the product, we swear

 

But we just found Listeria

All the product’s been retained

Listeria

Biofilms in our drains

Listeria

Might be from the supply chain

Listeria

Listeria

 

Bum Bum bio bum bum bio-film

Bum Bum bio bum bum bio-film

Bum Bum bio bum bum bio-film

Bum Bum bio bum bum bio-film

 

Risk assessments are now change-in

Zero tolerance And we’re jumpin-in

We didn’t no, oh, oh

Grab your swabs and let’s go oh oh

 

Let’s tear this room apart

We need to swab every square foot

Then the spare parts

We can get to the cause root

Use those trending charts

Why didn’t we catch this last year

It’s not in the product, we swear

 

But we just found Listeria

All the product’s been retained

Listeria

Biofilms in our drains

Listeria

Might be from the supply chain

Listeria

Listeria

 

Bum Bum bio bum bum bio-film

Bum Bum bio bum bum bio-film

Bum Bum bio bum bum bio-film

Bum Bum bio bum bum bio-film

 


Inspired by various warning letters at companies associated with outbreaks of Listeria monocytogenes. Original song performed by Rihanna, music composed by Robert Allen, Chris Brown, Andre Darrell Merritt, and Brian Kennedy Seals. Instrumental background sourced from www.karaoke-version.com.

This media file may contain copyrighted material that qualifies as fair use under the Copyright act of 1976. 17 U.S.C. Section 107. See Campbell vs. Acuff-Rose Music (92-1292), 510 US 569

 

FDA Warning Letters this week: A dirty glove is a dirty hand

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

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

A dirty glove is a dirty hand

This week I’m going to do something a little different, rather than review the entire contents of one or several letters, I wanted to address some common findings that showed up in some truly awful facilities that received warning letters recently. Among a huge number of general findings of insanitary conditions like dirty equipment, rotting food, and poor general upkeep, the FDA inspectors made some pointed comments about hand contact when gloves were used.

WL# 18-ATL-01

Subject: CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
   You failed to ensure all personnel working in direct contact with food, food contact surfaces, and food packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food as required by 21 CFR Part 110.10(b). For example:
 a.  Employees failed to maintain gloves used in food handling in an intact, clean, and sanitary condition as required by 21 CFR Part 110.10(b)(5). For example, an employee in the front kitchen was observed using gloved hands to assemble sanitized production equipment. This employee stopped assembly to manipulate the hose that had been on the floor and then resumed assembling the sanitized equipment without first washing and sanitizing or changing the gloves.
b.  Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated as required by 21 CFR Part 110.10(b)(3). For example:
i.    Multiple employees were observed returning from breaks without washing their hands or washed their hands and then put on hairnets and earphones, without first re-washing their hands, before resuming production activities in the front and back kitchens and the spice room.
ii.    Throughout the inspection the front and back kitchen mixer employees were observed touching non-food contact surfaces such as shovels, buttons, equipment, buckets, cardboard boxes, waste bins, drums, kettles, and tables with gloved hands, then using the same gloved hands, without first sanitizing or changing, to handle raw ingredients and subsequently handle finished product and food contact surfaces.
iii.    A production employee was observed after a break in production to come directly from the break area into the spice room, handle non-food contact surfaces including a door handle, tables, a screw driver and then handle food production equipment such as a mixer, paddle, and a hose without first washing or sanitizing their hands.
iv.    Employees were observed entering the front kitchen production room from the spice room, handling non-food contact equipment such as a radio, boxes, and a trash can and then not washing or sanitizing their hands before performing work that included their bare hands touching the interior of “(b)(4)” finished product containers.

WL# CIN-17-510879-04

Subject: CGMP Food/Prepared, Packed or Held Under Insanitary conditions/adulterated
Employees were not observed washing their hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Specifically…Employees engaged in food preparation were observed leaving the food preparation area, retrieving additional ingredients or packaging supplies, and taking phone calls. The employees were observed changing their gloves between these events, but they were not observed washing their hands prior to changing their gloves.
So what risk do the findings pose?

So….here’s the deal. Hands are obvious and effective vectors for disease. In general we tend to focus on the fecal-oral route (fingernails and cheap toilet paper kill people, wash up friends), but in a food plant, it’s important to watch where employees frequently interact with areas where they might touch “unclean” spaces and bring things back to the product, like bacteria on a dirty pallet or allergens from a snack/lunch while on break.

What’s missing here to evaluate the risk is some context. Generally employees can move from sanitary “food contact” surfaces without having to “intervene” on their hands, and some of the surfaces identified such as equipment buttons or screwdrivers could very well have been sanitized at the beginning of the shift so that clean-handed employees could use them without issue. That would be an efficient approach to startup sanitation. However, the other findings like coming back from break or handling items on the floor or obviously dirty equipment is normally out of the realm of best practice, and based on the awful sanitary state of the plants mentioned in the warning letters, it’s very likely that those surfaces/practices resulted in frequent cross-contamination. Good auditor.

What about the gloves?

This is more interesting, FDA specifically went after both manufacturers for using dirty gloved hands, because gloves aren’t magical. However, in the second warning letter above, FDA was pretty strict in that they didn’t consider the glove change adequate as an intervention. The general thought process here is that if you take off a pair of dirty gloves, your hands get dirty in the process. Therefore putting on a new pair of gloves with “dirty” hands means that your new gloves get contaminated regardless.

The “gloves or no gloves” debate typically focuses on the fact that it has been shown that glove use actually reduces hand washing compliance in healthcare and food settings, because people think the gloves make their hands cleaner. While dirty hands get washed (eew, there’s dirt on my hand), dirty gloves get worn.

The other half of the risk assessment though is based on bacterial transfer rates. And on this half, it has been shown that bacteria transfers from food to bare hands at about a 10% rate while through a glove it only transfers at a 0.01% rate. So even if you contaminated your hands while taking off an old pair of dirty gloves, only a tiny amount of those bacteria would actually make it back through a new pair of gloves. Though that doesn’t matter if you then contaminate the contact side of a new pair of gloves with your dirty hands, and it has been shown that handwashing between glove changes reduces that incidence! BUT it turns out that surgeons do this to protect themselves from getting contaminated during surgery without handwashing when changing gloves aseptically, so it’s common practice in other aseptic fields!

*pant, pant*

So…it’s complicated. But there is a potential third option, even if it isn’t generally considered in the guidance (by the way, mandatory washing between glove changes isn’t actually codified anywhere, but is enforced guidance and part of GFSI schemes).

So we’ve concluded that putting on gloves with dirty hands results in dirty gloves. Fine. But once you’ve put on a smooth, impervious, surface that can be cleaned and sanitized, you no longer have a glove, but a “food contact surface” just like a spoon! And spoons (if visibly clean) can be sanitized before returning to use.

We know that, in general, current handwashing recommendations can result in a 2-3.5 log reduction of bacteria on hands. This is the best we can realistically hope to do with current practice, and we rely on handwashing to prevent either low levels of contamination, or to simply remove visible filth that carries higher numbers of bacteria. Further transfer to food depends on transfer rates that are highly variable, and actual food safety risk depends on what’s transferred and whether it has the ability to keep proliferating.

We also know that gloves can be removed with minimal transfer per medical literature, and that only 0.01% of bacteria will make it from a “dirty” hand through the glove. So we just need to take care of those pesky bacteria on the outside of the glove. Too bad there isn’t some kind of way we could quickly treat a visibly clean food contact surface…say a 5-log reduction in like, 30 seconds to a minute…

Enter glove/hand dips. A method where in critical areas you maintain a “bath” of sanitizer prepared to manufacturers specifications that will provide a 5 log reduction of pathogens on a clean surface. By changing your gloves and sanitizing them by dipping them in your solution, you can empiracally achieve a much higher reduction in organisms on the contact surface than you would achieve by de-gloving>handwashing>re-gloving. Even better, you can do it just as quickly has a hand wash and can put these hand dips in convenient locations. Basically, you treat your hands as if they were a utensil like a spoon instead of hands.

FDA references these “hand dip” or “glove dip” stations in the Food code (2-301.16), refers to them in guidance related to nut processing, warning letters, and specifically states in a risk assessment on sprouts processors (emphasis mine):

Hand dip stations are important to sanitize clean hands and gloves.

Important language distinction here is that they said “clean gloves”, they still need to meet a visibly clean standard for the sanitizer to work, but if there is no visible contamination, you’re ready to sanitize, and a fresh pair of gloves out of the box will normally meet this standard.

Hand dip stations are also referenced in some older FSIS publications.

So, from a scientifically validated approach, glove dip stations should be as or more efficient as handwashing between glove changes. Unfortunately because of the abundance of state and FDA guidance mandating a “wash” between glove changes, different auditors may be more or less open to this procedure even if it has been properly validated/verified. However, the entire point of HACCP or HARPC is that you can establish whatever procedures work best for your plant/process that can be substantiated scientifically. Try it out, collect enough data to demonstrate that it works, and slip this blog post in your citations if it helps ;).

Literature:

Fuller, Christopher, et al. ““The dirty hand in the latex glove”: a study of hand hygiene compliance when gloves are worn.” Infection Control & Hospital Epidemiology 32.12 (2011): 1194-1199.

Montville, Rebecca, Yuhuan Chen, and Donald W. Schaffner. “Glove barriers to bacterial cross-contamination between hands to food.” Journal of Food Protection 64.6 (2001): 845-849.

Robinson, Andrew L., et al. “Adequate Hand Washing and Glove Use Are Necessary To Reduce Cross-Contamination from Hands with High Bacterial Loads.” Journal of food protection 79.2 (2016): 304-308.

Jensen, Dane A., et al. “Quantifying the Effects of Water Temperature, Soap Volume, Lather Time, and Antimicrobial Soap as Variables in the Removal of Escherichia coli ATCC 11229 from Hands.” Journal of Food Protection 80.6 (2017): 1022-1031.

 

Missing CFR definitions: So what does “food-grade” actually mean?

Not food-grade...or is it?I was looking over the SQF code the other day and pondering the phrase “food-grade” for lubricants and chemicals, then I got home and noticed the “food-grade” sticker on my CO2 canister in my kegerator.

This is what we call nerd-sniping,  regulatory edition.

I sat down and started searching Title 21 of the Code of Federal Regulations, and in this case I was searching for a specific definition. After all, FDA uses the term “food-grade” in some of their guidance documents and individual chemical requirements, so they must have defined it, right?

…well maybe it was included in the original FD&C text, like some of those random standard of identities and definitions?

…well maybe they didn’t duplicate it, but it’s defined in Title 9 for USDA regulations then?

……well, crap. Well, if the bad bug book can cite wikipedia, then maybe FDA will include this blog post as a guidance document at some point.

If “food” is “food-grade”, then what is the term used for?

Since the term appears in the SQF and other codes, it’s usually a good assumption that you can find a definition in the codex alimentarius, maintained by the FAO and member nations. And if a US national standard doesn’t exist, it’s typically safe for manufacturers to refer to an international standard of some kind.

So, a quick search for “food-grade” in codex leads me to…

Okay, they use the term frequently for specific food additive standards (e.g. food grade salt, agar, and edible insects).

Maybe I’m overthinking this…maybe this is just a dictionary definition, and while I, as someone regulated under this standard, feel like it should have been codified, maybe I’m just supposed to take Oxford’s broad interpretation:

Of a quality suitable for human consumption, or for use in food production or storage.

I really don’t like attributing “food-grade” to just a substance that happens to be used in food production…that’s almost tautological. So in this case, I’m assuming I’m expected to examine each ingredient or food contact substance individually and make a judgement call based on standards that are or aren’t available, or just avoid anything hazardous that may somehow come with that ingredient. So where can we start?

The Food Chemicals Codex Standard (FCC)

The US Pharmacopeia (USP) is an organization that helps develop global public health standards and works closely with codex and helps publish the FCC monographs. These “monographs” are basically standards of purity necessary for specific uses of food ingredients. For example, salt has several levels of purity depending on use. Salt can be used in industrial chemistry in the petroleum industry or pesticide creation, it could be used as an ingredient or carrier in foods, or it could even be used as an inject-able substance in medicine. Each of those intended uses has a different purity standard, and you only want to do as much as necessary to make the ingredient safe for use. So, using this resource, items that hold the FCC purity standard would certainly be “food-grade”.

Back to the USA then, since we’re now operating outside of any sort of regulated definition of “food-grade” for foods in general. We can move past obvious foods and ingredients like produce, where “food-grade” would generally be assumed to be articles intended for human consumption that do not contain any poisonous or deleterious substances above any regulated threshold. We can also very easily find guidance for new food additives and functional ingredients that go through a normal review process.

What about the other stuff? Packaging, sanitizers, lubricants…

This really ends up being both easy and hard. You can certainly find products labeled food grade, and food packaging suppliers (selling to industry, not the public) will readily send you letters and specifications indicating that the plastic resins and other materials are safe for food contact. But establishing under what standard these items are held to is more difficult.

Food-Grade Packaging materials: FDA regulates substances used in food packaging and has migration standards to to make sure that anything in the material doesn’t transfer to the food in a significant way.

Food-Grade Lubricants and Maintenance Chemicals: In areas above food contact surfaces or in machinery that handles food, these chemicals are expected to occasionally enter food in small amounts. So they need to be safe for consumption in small amounts. FDA has a list of these materials and a general safety/purity standard. NSF has a great discussion of these standards and other international standards for lubricants, and provides certifications for these products that are very much accepted by both FDA and 3rd party auditors. NSF also helps approve food contact surfaces.

Food-Grade Sanitation Chemicals: FDA has a list for sanitizers and other “substances utilized to control the growth of microorganisms”, and includes the most common active ingredients as well as whether the sanitizer requires a rinse or not to make sure that no harmful residues are left behind. Once again, this is assuming that we aren’t feeding people these things, the SDS may still say they are toxic if swallowed, but in small amounts or “good manufacturing practice” they will be harmless.

Food-Grade Compressed Gasses: This is one that is very undefined. For example, FDA references Nitrogen’s GRAS status with this helpful note:

 The ingredient must be of a purity suitable for its intended use.

Very scientific FDA. So we have no domestic purity standard for compressed gases for food use, however we have established one for medical use. I spoke with a representative of Airgas over the phone, who stated that the only difference between gas cylinders sold with the “food grade” or “beverage grade” claim was their procedure for cleaning the tanks and tracking the gas by lot. This would make sense if they needed to follow a sanitation protocol or avoid/remove residues of any non-food grade lubricants used in industrial applications other than food, and if their typical “basic” gasses are already of high purity.

Internationally for the EU and European pharmacopeia there are standards for compressed gas purity, and in the US it would be assumed that “food grade” gasses would comply with the FCC monograph. An example one for Nitrogen can be found here.

So at the end of all this, is the answer simply that FDA could not come up with a “food-grade” standard that applied to all these types of materials? Or perhaps they thought that all these cases were already contained within their “adulteration” and “poisonous and deleterious substances” definitions. I still take issue with the fact that they use this phrase so heavily throughout the regulatory text that a definition should have been necessary. So, FDA, for your review, I submit the following definition:

As described in Fur, Farm, and Fork:

Food-Grade substance:  A substance that, when used within good manufacturing practice, is suitable for its intended use, does not introduce any poisonous or deleterious components to the food, and complies with any federally adopted purity standards

 

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!

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

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

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

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

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

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

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

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

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

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

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

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

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

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

How exactly would someone actually test for fecal material?

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

1. Direct (macro) observation

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

2. Microscopy

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

3. Chemical Indicators

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

4. Microbiological Profile

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

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

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

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

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

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

 

 

Resources for fecal identification forensics:

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

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

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

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

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

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

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

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

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

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

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

fsis enforcement reports data (.xlsx)

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

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

 

 

 

 

 

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


verification-procedures-performed

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

compliance-rate

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

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

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

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

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

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

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

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

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

 

ResearchBlogging.org

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

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

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

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

WL# 17-ATL-12

Subject: Food Labeling/Misbranded/False and Misleading

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

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

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

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

Thank you FDA!

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

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

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

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

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

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

How far off from label is too far?

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

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

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

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

Back to the letter…

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

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

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

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

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

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

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

 

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

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

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

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

Bold, FDA….bold.

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

Summary

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

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

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

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

Sell your product, not the label.