Quaker Gluten-Free Oatmeal: Take Two

DISCLAIMER: The information included in this post is based on a 2-hour phone conversation with Quaker and extensive written information provided by Quaker in follow-up emails. Quaker reviewed the information included in this post for factual accuracy.

In October 2015, Quaker Oats debuted three gluten-free oatmeal products—Quick 1-Minute Oats, Instant Oatmeal Original, and Instant Oatmeal Maple & Brown Sugar. The oats used in these products are not produced under a gluten-free purity protocol; they are mechanically and optically sorted to be gluten-free.

What we have learned at Gluten Free Watchdog through speaking with three companies (i.e., General Mills, Grain Millers, Quaker) is that the processes used to mechanically and optically sort oats to be “gluten-free” are not the same among manufacturers. As a result, each manufacturer using this methodology must be assessed on an individual basis.

Bottom Line: After a lengthy and relatively transparent conversation with Quaker about their mechanical and optical sorting and testing protocols we are somewhat optimistic that “gluten-free” Quaker oats may be appropriate for individuals with gluten-related disorders. However, at Gluten Free Watchdog we must conduct our own independent testing before a complete assessment of Quaker gluten-free oatmeal products can be made. We do not endorse the use of Quaker gluten-free oatmeal products at this time by individuals with celiac disease and gluten-related disorders.

Note: Gluten Free Watchdog will be testing Quaker Oatmeal products when they become available nationwide in January and we will release another statement at that time.

The process used by Quaker to convert commodity oats into “gluten-free” oats:

• When commodity oats arrive at the mill (Cedar Rapids, Iowa), each railcar is visually assessed for the level of gluten-containing grain. The railcars with lower amounts of visible gluten contamination are designated for possible use in gluten-free oatmeal; oats with higher levels of contamination with wheat, barley, and rye are designated for use in regular oat products.
  • Note: GFWD would like to see Quaker take steps to source oats from farmers who do not grow wheat or barley or at least have the “cleanest” oats.
• Oats designated for possible use in gluten-free oatmeal undergo mechanical and optical sorting.
• A sample of sorted “cleaned” oat groats (defined by Quaker as the “oat without a coat”) is collected every hour via a continual flow process.
  • For each “lot” of oat groats, an amount equal to 3,000 (40 gram) servings of oats is pulled.
    • Note: GFWD asked Quaker about the total gram amount of product in one lot. Their response: “For competitive reasons we cannot give you exact numbers. What we can tell you is that a lot of oat groats is up to five consecutive days of a production run.”
  • Quaker actively looks for contamination by concentrating any potential sources of wheat, barley, and rye.
    • This sample (3,000, (40 gram servings) of oat groats is mechanically sorted to concentrate any possible grains that are not oat groats.
    • The possible non-oat grains are examined kernel by kernel by a “single kernel analysis machine.” This is an optical sorter.
    • Any possible non-oat grains determined by single kernel analysis are sent to the lab for testing.
  • The protocol for testing at this step is fairly complex:
    • 75 gram samples are divided into 5, 15 gram samples.
      • The number of 75 gram samples varies per lot but at times is up to 40, 75 gram samples.
    • ONE 15 gram sub-sample from each 75 gram sample is ground and tested using what Quaker terms their “mass extraction method.”
      • Note: GFWD asked Quaker to provide additional information on their mass extraction procedure. Quaker’s response: “We spent considerable time perfecting the mass extraction procedure to overcome the lack of homogeneity within samples (due to kernel contamination) that could skew testing based on 0.25 g. For this reason, we only employ the mass extraction procedure to test the non-groat samples. We do use “Mendez” cocktail, however the amount of “Mendez” cocktail and other solvents are proportionally increased to extract gluten from 15 g. We have experimentally proven that this “mass” extraction procedure is as effective as the original procedure. As mentioned, we are considering publishing this work and associated details in an appropriate scientific journal.”
      • Note: GFWD encourages Quaker to submit their experiment to a peer-reviewed scientific journal. 
      • Update: November 23, 2015: We reached out to the assay manufacturer R-biopharm for comment on the modifications made by Quaker to the R7001. Their response: “… as long as the ratios are kept proportionally, there should be no problem apart from the handling and waste problems of such large volumes… when scaling up to 15 g weigh in, one will need 150 ml Cocktail and 450 ml 80% ethanol. Since it will take very long in a water bath to heat 150 ml Cocktail to 50°C, I would recommend to pre-heat the Cocktail to 50°C prior to adding it to the sample.” In a follow-up email R-biopharm wrote, “Indeed we have already updated the instructions for use for the Gliadin ELISA when testing oat samples, since we had a few customers and also internal experiments showing that oat samples can be quite inhomogeneous. The updated instructions for use will soon be available in the test kits. However, we prefer not to generally instruct to use higher sample intakes, since the vast majority of samples is sufficiently homogeneous and a general increase in weigh in will also increase the costs for the customers. But the customers are of course free to decide on their own to increase to 1 g of sample weigh in – we also know that some customers do 1 g weigh in for all samples.”
      • Note: According to Quaker, they follow R-biopharm’s recommendation.
      • If the test result on the 15 gram sub-sample is below the lower limit of quantification (5 ppm) then the 75 gram sample “passes.”
      • If the result is at or above 20 ppm, the 75 gram sample fails and the entire lot of oat groats is sent to non gluten-free oat processing.
      • If the result is between 5 and 20 ppm, the remaining 4, 15 gram sub-samples are ground and tested.
      • For the lot of groats to “pass” and move onto the cutting, flaking, and packaging phase, the mean of the 5 tests must be less than 10.67 ppm gluten with no test result at or above 20 ppm gluten.
      • Note: GFWD is concerned that gluten contamination from the 75 gram sample may not be evenly distributed within the 5 (15 gram) samples. Quaker’s response, “We have thoroughly validated the performance of the single kernel detection device to ensure its capability… “When we are evaluating just a single 15g sub-sample, our research indicates that a BQL result requires no further testing.” 

Note: Early single kernel analysis inspections revealed that some wheat and barley remained in the “cleaned” oat groats (these were non-commercial runs). Adaptations were made to the mechanical and optical sorters. According to Quaker, since beginning their commercial runs, they have not found a single wheat, barley, or rye kernel in the oat groats designated for gluten-free oatmeal (based on visual analysis using the “single kernel analysis machine” of the 3,000 (40g) oat groat samples from each lot).

• Oat groats that pass gluten-free inspection are sent to the mill (oat groats that do not pass gluten-free inspection are designated for non-gluten-free oat products).
• Oat groats are cut and flaked for gluten-free oatmeal using dedicated gluten-free equipment.
• Gluten-free oat flakes are stored in dedicated gluten-free mobile storage tanks.
• Gluten-free oat flakes are packaged using equipment that is not dedicated gluten-free.
  • Gluten-free oatmeal is gravity-fed through a dedicated spout into the filler.
  • Packaging equipment consists of both machinery that fills the tubes and pouches with oatmeal and seals it AND equipment that packages the tubes and pouches into cases and cartons.
  • Quaker states that they take the necessary steps to restore the line to gluten-free status, including thorough swab testing for gluten to ensure no risk of gluten contamination.
    • Note: Regardless, GFWD would like to see Quaker move towards dedicated packaging equipment. Quaker’s response, “We understand why the idea that we are not using dedicated packaging equipment may cause concern. Let us assure you that while many parts of the process of creating gluten free oatmeal are relatively new, the cleaning protocol for the packaging lines is something we’ve been doing for years. It’s part of our stringent food safety standards and how we ensure that we are always in compliance with any allergen statement on our packaging.”
  • The oatmeal then undergoes finished product testing.
    • 16 pouches or tubes are pulled during a production run (approximately 1 pouch or tube every ½ hour).
      • Note: Approximately 400,000 single serving pouches are produced during a lot run; 50,000 tubes are produced during a lot run.
    • A 40 gram sample is taken from each pouch or tube.
    • The sample is homogenized.
    • Two extractions are taken from the homogenized sample and tested using the Ridascreen Gliadin R5 ELISA (R7001) Mendez Method.
    • If any single extraction from any of the 16 pouches or tubes is above 12 ppm gluten the entire lot is discarded.
    • Since beginning commercial runs, three early runs were above 12 ppm gluten and these lots were destroyed. Since taking corrective action, 25 additional lots have been run. All but one extraction from finished product gluten-free oatmeal tested below 5 ppm gluten; one extraction tested just above the lower limit of quantification of 5 ppm gluten (6 ppm).
    • UPDATE Jan 20, 2016: In email correspondence, Quaker writes, “we have continued to implement the testing protocol we shared with you for finished product. Out of our last 50 lots produced, we have had one lot test above 12ppm; as a result, that entire lot of finished product was destroyed. All other lots produced met or exceeded our standards and were released into market.”

What we like:

Quaker is…

• Testing individual containers and packets of oatmeal for gluten.
• Using the fully validated sandwich R5 ELISA Mendez Method (R7001) to test finished product oatmeal for gluten contamination.
• Testing each homogenized sample in duplicate.
• Not compositing samples.
• Not taking a lot mean to determine the safety of finished product
  • All finished product test results must be at or below 12 ppm gluten.

We also like two statements made by Quaker regarding their testing protocol:

• “Customers eat by serving, not by lot, and should expect their servings to be compliant.”
• “It’s not enough to treat gluten testing as a quality control measure, using traditional quality control methods (lot testing, compositing samples, etc.).  Traditional quality control methods just don’t work for gluten testing in oats.  At Quaker, we treat gluten testing as a food safety measure, which requires a different way of thinking and significantly more robust control systems to ensure the objective is met.”

What we would like to see improved:

We would like to see Quaker…

• Increase efforts to source oats from farms not growing barley and wheat and/or who routinely provide the cleanest oats.
• Take steps to evenly distribute (via homogenization) any gluten contamination within the 75 gram samples of possible non-oat groats before testing ONE 15 gram sub-sample.
• Publish the internal validation of their “mass extraction procedure” in a peer-reviewed journal.
• Use dedicated gluten-free packaging equipment.

Final thoughts

At Gluten Free Watchdog we are supportive of the use of oats by the celiac disease community that are produced under a gluten-free purity protocol. In general we are not supportive of commodity oats cleaned via mechanical and optical sorting. However, each manufacturer using this technology must be assessed on an individual basis.

The million dollar question for each brand of mechanically and optically sorted “gluten-free” oats is whether testing of oat ingredients (e.g., oat groats, oat flour) and finished product (e.g., Quaker Oatmeal, Cheerios) is sufficient to find gluten contamination if it is present. Adequate testing is a huge issue due in large part to gluten contamination in oats not being evenly distributed throughout a “lot” of oats.

While Gluten Free Watchdog is somewhat optimistic about the protocols followed by Quaker to produce gluten-free oat products we do not endorse the use of Quaker gluten-free oatmeal products at this time by individuals with celiac disease and gluten-related disorders. We will release another statement after conducting our own third party testing on these products. In addition, we continue to advise against the use of General Mills’ “gluten-free” Cheerios by individuals with celiac disease and other gluten-related disorders. We also advise against the use of all other oat-based “gluten-free” foods from manufacturers who do not source ALL of their oats from suppliers of purity protocol oats.