Friday, August 23, 2013

Kinnikinnick K2 Facility Earns HACCP Food Safety Certificate.

Update: June 30, 2014

Our K2 facility has just passed its re-certification audit with flying colours, scoring even higher than our first audit. Our preparations for BRC continue and we hope to have our first BRC audit by the end of the year.

We are very pleased to announce that our K2 Facility received its HACCP Food Safety Certificate on July 26, 2013.

HACCP stands for Hazard Analysis & Critical Control Points. HACCP is a systematic preventive approach to food safety and biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe, and designs measurements to reduce these risks to a safe level. In this manner, HACCP is referred as the prevention of hazards rather than finished product inspection. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. *

Two years ago, we made the decision to "up our game" in food safety and began the long path to HACCP certification.

Seven Principles of HACCP (from wikipedia)
Principle 1: Conduct a hazard analysis. – Plans determine the food safety hazards and identify the preventive measures the plan can apply to control these hazards. A food safety hazard is any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.
Principle 2: Identify critical control points. – A critical control point (CCP) is a point, step, or procedure in a food manufacturing process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to an acceptable level.
Principle 3: Establish critical limits for each critical control point. – A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.
Principle 4: Establish critical control point monitoring requirements. – Monitoring activities are necessary to ensure that the process is under control at each critical control point.
Principle 5: Establish corrective actions. - These are actions to be taken when monitoring indicates a deviation from an established critical limit. The final rule requires a plant's HACCP plan to identify the corrective actions to be taken if a critical limit is not met. Corrective actions are intended to ensure that no product injurious to health or otherwise adulterated as a result of the deviation enters commerce.
Principle 6: Establish procedures for ensuring the HACCP system is working as intended. – Validation ensures that the plants do what they were designed to do; that is, they are successful in ensuring the production of a safe product. Plants will be required to validate their own HACCP plans.
Verification also includes 'validation' – the process of finding evidence for the accuracy of the HACCP system (e.g. scientific evidence for critical limitations).
Principle 7: Establish record keeping procedures. – The HACCP regulation requires that all plants maintain certain documents, including its hazard analysis and written HACCP plan, and records documenting the monitoring of critical control points, critical limits, verification activities, and the handling of processing deviations.

We chose to be certified under the new AHA program  developed by the Alberta & Canadian Governments.

Alberta HACCP Advantage (AHA!) is a voluntary program established by Alberta Agriculture and Rural Development (ARD), in cooperation with Agriculture and Agri-Food Canada. AHA! is a food safety program that has resources to assist processors in developing, improving and implementing a food safety system to meet the requirements of their current customers and may also help gain new customers. AHA! was developed to complement current food safety regulations, and to facilitate consistent program development within the processing industry.
The goal of the Alberta HACCP Advantage (AHA!) program is to assist processors in implementing a complete and effective food safety program. An effective food safety program identifies hazards and measures to prevent, eliminate or reduce hazards during the processing and production of food. It is an outcome based approach, which provides flexibility during implementation, regardless of your operation. *

To qualify for certification, facilities must comply with the 7 principles and undergo an extensive audit by an outside agency. For one week in May of this year, an auditor from QMI-SAI Canada Ltd. reviewed our facility, procedures & documentation.

On July 26, we received our official certificate.

We are one of only 4 AHA HACCP Certified Facilities in Alberta and we are very proud of the hard work done by all our staff (especially Charmei, our HACCP Coordinator) to achieve this benchmark.

We're not done yet.

We had originally planned to complete HACCP certification of our smaller K1 facility by the end of next year, but we have recently made the decision to certify both our K1 & K2 facilities under the even more stringent BRC Global Food Safety Standards. BRC certification is the world's leading standard for food safety and will further our commitment to provide our customers with the safest possible gluten free food.

Read More

< 5ppm gluten: Labeling and Science vs the Real World
Gluten Testing & our New Lab Tested Gluten Free Logo
Kinnikinnick Foods Receives Kosher Certification
Kinnikinnick's Position on Oats in Gluten Free Food
The Importance of a Dedicated Gluten Free Facility
Keeping "Gluten Free" Free Of Gluten



Thursday, August 15, 2013

< 5ppm gluten: Labeling and Science vs the Real World

Twitter, Facebook and the internet in general are wonderful things. But they are not without problems. This morning, as I normally do, I checked out Twitter mentions and Facebook posts. On Facebook I saw a nice post about our Pizza Crust.  I flipped over to Twitter and saw a mention from someone saying that our pizza crust had caused a gluten reaction and that it wasn't gluten free and that we were lying about our products being gluten free. This caused several of her followers to become very concerned. One was afraid they had "poisoned" her baby by giving her some of our products.

Now, obviously we never want to hear that someone feels unwell after eating one of our products. We have a formal complaint tracking system for this. However I did want to clarify our gluten free status, the strict testing and ingredient sourcing protocols we have in place and our 22 year commitment as a dedicated, family run gluten free company. This did not go well. Twitter's 140 character limit is not the best method to explain something to someone who is feeling unwell and angry. I want to expand on what I posted on Twitter in a form that allows for some continuity and clarity.

One of the things that I tweeted was

"We guarantee our product to be gluten free to < 5ppm (which is the limit of science)"
The reply to this was that this tweet was proof that we were not gluten free and that we shouldn't be allowed to label our products gluten free. I won't refer to this twitter conversation any more but if you feel you'd like to judge our response, our Twitter account is public and we stand behind everything thing we said.

So let's talk about PPM. What does it mean? What's safe? What are the rules? What's the science behind testing?

Warning: Science & Math Ahead

What does PPM mean?
PPM is short for Parts Per Million. OK most everyone knows that. But what does it -really- mean. A million is a pretty big number but it's helpful if we break it down to a real world example.

 So 1ppm is 1 ounce in 1 million ounces or 1 gram in 1 million grams. Hmmm, that's not easy. It becomes a bit easier when you convert that to pounds and kilograms

1ppm = 1 ounce in 62,000 pounds (31.25 tons)
1ppm = 1 gram in 1000 kilograms (1 metric tonne)

Now -that- starts to show you the kind of numbers we are dealing with here. 

Let's give you an actual example. A standard grain car contains about 80 tons (160,000 pounds) or 72.6 metric tonnes (72600 kilograms)*.

To find out what 1ppm of -something- in that grain car would be, all we need to do is run a calculation.

1 ppm      X ppm
31.25tons = 80tons

X = 2.56

If 1 ppm is 1 ounce in 31 tons, 1 ppm in a grain car looks like this:

2.56 ounces per 160,000lb
72.6 grams per 72,600kg

Probably the easiest way to think of what 1ppm means is this:

1ppm = 1 You in a room with a Million people.

or maybe

1ppm = 1 needle in a haystack of a million pieces of hay.

It's very small indeed.

The Rules

For many years, the Codex Alimentarius had a standard of 200ppm and this was widely accepted in Europe and the UK.

Until 13 days ago, the US had -NO- regulations as to what constituted a gluten free product. Let me repeat that. There were no regulations governing gluten free products in the US. Until August 2, 2013.

Up until last year, Canada (where we are based) had an informal limit of 20ppm for product labelled gluten free, although the regulations explicitly said "none". The 20ppm was  what was referred to as the "enforcement threshold". That is, if a product tested higher than 20ppm and was labelled gluten free it was subject to a recall. These guidelines were the strictest in the world and have been in place for at least 15 years and maybe longer. This is the regulatory environment Kinnikinnick "grew up" in.

Fortunately, things have started to become clearer world wide.

Last year Canada released the new guidance for gluten free labeling which basically formalized and clarified the pre-existing rules.

Since 2008, the Codex has an updated standard to set a threshold of 20ppm. (pdf)

In August 2013, after 9 years of deliberation and consultation (and I expect a good deal of lobbying), the FDA finally released the rules for what is allowed to be labeled gluten free. Companies have 1 year to comply.

One note on Oats and gluten free. While the new US regulations allow them, both Canada & the Codex do NOT allow Oats or products containing oats to be labeled gluten free. These agencies recognize that oats can be tolerated by most but not all people who are intolerant to gluten. This is a position we also take and we do not use oats in any of our products.

Because of the major uncertainty, especially in the US, about what gluten free actually meant, several celiac support groups drew up their own guidelines and created gluten free certification programs. The allowable PPM for certification from these groups ranges from 10-20ppm. While this filled a void, we choose to certify our own products.

Some of you may say "well, why would we trust you over a certification organization?" The answer is simple, if a company does not comply with a certification organization standards (ie: tests over 10 or 20ppm) then they risk being dropped by the certification organization (although I expect there is a process to "fix things" to retain status). Because we label our products with our own logo which claims <5ppm we are legally bound to provide that. There are no certification organization bodies that can claim that. There are a couple of companies who claim 100% gluten free but we'll get to why that is unsupportable shortly.

What's Safe.

Here's a good question. How much gluten is safe for the general celiac population. There's not an easy answer. It used to be extraordinarily confusing for consumers,but in recent years things have started to become clearer.
As of August 2013, at last, the consensus of governments, science, support groups and certification organizations has set the safe maximum level to be somewhere between 10-20ppm.

These numbers come with one caveat, especially at the 20ppm level. This is safe for the -average- celiac to consume and cause no damage. This does not mean -you- won't react to 20ppm. This is why some certification organizations have chosen to have a 10ppm standard. And remember, 20ppm per product is additive. This is up to 20ppm -per product- you eat per day. If you eat a lot of products in a day that are at or near 20ppm, even "average" celiacs may be getting enough to cause a problem.

This is why we have chosen the < 5ppm standard.

The Science of testing for gluten (and why claims of 100% gluten free are unsupportable)
Before we get to the < 5ppm standard, it might be helpful for a quick refresher on our standards. For a complete overview please see our post Gluten Testing and Our New Lab Tested Gluten Free Logo

I'll summarize some important points from that post:

  1. In general, all the tests on the market today are looking for gliadin, which is a protein in wheat. This protein is most commonly referred to as gluten. 
  2. It's  important to realize that for testing, gliadin & gluten are not the same thing. A gliadin result of 5ppm means it contains 10ppm gluten.
  3. The Level of detection of gluten is different than the level of quantification (translation: you can tell gluten is in something at a lower level than you can accurately say how much there is)
  4. The only accepted & verified test for determination of gluten is Enzyme-linked Immunoassay (ELISA) R5 Mendez Method.
  5. The most sensitive test available to science (that is recognized) is the R5 ELISA Quantitative test, with a Limit of detection of 1.5ppm gliadin/3ppm gluten.
  6. We use both the R5 ELISA Quantitative (how much) test and the R5 ELISA Qualitative (yes/no) test which has a limit of detection of 2.5ppm gliadin/5ppm gluten.
  7. The large majority of our suppliers are dedicated gluten free. For those that aren't, where alternatives are not possible, we have extensive documentation on their procedures and rigorous testing of every lot.
  8. We test both incoming ingredients and finished products using both the qualitative and quantitative tests depending on the ingredient.
  9. All our finished products must test below 2.5ppm gliadin/5ppm gluten.
The most important point for this blog entry are points 4 & 5. The testing we use is the only one that is universally accepted to be accurate. The very smallest amount that it can identify is 3ppm gluten. Not 1ppm and certainly not 0ppm. Can a company who claims to be 100% gluten free (which is 0ppm) have absolutely no gluten in their product. Yes. Can they prove it? No. Since the most accurate test in the world can only test to 3ppm, the most they can say is they have 3ppm or less or perhaps < 5ppm (see where I'm going with this?)

< 5 ppm and the real world.

Let take an example of a gluten free bread by Brand X. We'll say that 1 slice of our example bread is approximately 1 ounce or 28 grams. (your brand may be heavier & denser ;)

How much gluten would be in the product under the 20, 10 & 5ppm standards.

I'm only going to work in grams because there's really no useful measure below ounce.

So using our example above we know that 1ppm = 1 gram in 1000 kilograms.

20ppm = 20grams in 1000 kilograms or 20000mg in 1000000000mg = 0.00002
10ppm =  10grams in 1000 kilograms or 10000mg in 1000000000mg = 0.00001
5ppm =  5grams in 1000 kilograms or 5000mg in 1000000000mg = 0.000005

So for a 28 gram sample (28000 millgrams) we get the following totals.

20ppm = 0.56mg gluten/28 gram serving
10ppm = 0.28mg gluten/28 gram serving
5ppm = 0.14mg gluten/28 gram serving****

 (ok for those of you who still want ounces - 5 ppm  = 0.0000128oz/1 oz serving)

Now even at 20ppm, 0.56mg is not very much. About the weight of half of an eyelash. Or perhaps 1 crystal of granulated sugar. Or a grain of sand. It's a truly tiny amount. But our bodies ("our" being us celiacs) are truly remarkable and this tiny amount can cause issues for some people. Based on our current knowledge ("our" being Science's) very few would react to 0.28mg and virtually none to 0.14mg.

But here's the thing. You'll notice I've added ****  to the 5ppm amount calculation.

When we do the testing on our finished products we use the 5ppm Quick Test (qualitative yes/no). A Pass mean no detection. A fail means detection. (we've never had a fail by the way) So a pass means that there is, yes, you guessed it < 5ppm.

Update: I just received and email from our QA lab manager saying "hey, we haven't used quick tests for finished products for quite a while."

Here's what he had to say:

For finished products we use microwell strip format ELISA with heated cocktail extraction based on AOAC Official First Action Method No. 2012.01.

As a routine procedure we use the kit in a screening mode by running a 5 ppm standard alongside the samples and then comparing optical densities of the sample wells to that of the 5 ppm well using a spectrophotometer. If we were to encounter a positive sample that tests above 5 ppm we would build a full scale calibration curve with 5 standards.

It’s more time consuming (1.5 hrs just for the assay), but ensures better detection and/or quantification of glidain in heat treated foods.

(I actually knew this but yesterday had me linking to the post from 18 months ago and that's how we -used- to do it)

 Now I'll translate. Turns out that heat treated products (ie: any baked goods) are much harder to test because heat treatment changes the protein structure. Quick tests can't properly do the job. Even the sensitive test has challenges and the samples require extra, specialized processing (the heated cocktail extraction thing)

Another point to make. Every test we do takes an minimum 90 minutes.This stuff is not easy or cheap folks.

Here's the really important thing. The reason for this post. If we say our products are guaranteed to < 5ppm, this does -not- mean there is 0.14mg of gluten in it. (or rather less than 0.14mg) It means this:
  • We have researched our suppliers products, procedures and standards.
  • We have tested incoming ingredients.
  • We have made our products in our 2 dedicated facilities (where staff are forbidden to even bring gluten containing bread to lunch).
  • We have regularly verified our testing results with outside labs.
  • We have tested our finished products to have < 5ppm gluten.
 It would be awesome if I could tell you that our products had 0ppm gluten, but to do so would be inaccurate because the Science won't let me.

What I can tell you is that our products are the gluten free-est gluten free products around*.

* If some other manufacturer wants to dispute that I'm fine with that. Just post your testing and protocols for everyone to see, like we do. As a celiac of 16 years and gluten free consumer, I really wish you would.

Jay Bigam
Executive VP


Monday, August 5, 2013

Kinnikinnick is now a Sesame Free company

As many of you know, Sesame Seeds are one of the top allergens. For several years now, our K2 facility that produces our cookies, muffins, waffles, mixes and some breads & buns has been sesame free.  About 2 weeks ago, we stopped producing our last product that contained Sesame Seeds at our K1 facility.

This makes us now a completely Sesame Free company to go along with being Gluten, Dairy, Peanut & Tree Nut, Shellfish, Fish & Mustard & Latex Free company.

Packaging that mentions Sesame in an allergy warning will now gradually disappear as we reprint.