June 22, 2009With all the discussion over Evanger’s recent run-in with FDA, I thought it would be useful to piece together the entire chain of events for eFoodAlert readers. Last Wednesday, I sent an email to Joel and Holly Sher, asking for their cooperation. The outcome was a 35-minute telephone conversation with Joel, followed by a series of email exchanges.
How It Began
In 2002, Joel and Holly Sher purchased Evanger’s, a Wheeling, IL pet food canning company, which was founded in 1935. The couple spent the next two years renovating the canning facility, learning the intricacies of manufacturing canned pet foods, and developing a network of local suppliers of fresh meat and produce for their pet foods.
Under its new ownership, Evanger’s strove to gain a reputation among pet owners for producing high quality canned pet foods. The Company, thanks to its reliance on domestic suppliers, was not involved in the 2007 melamine-related pet food recalls. In fact, under its current management, Evanger’s has never experienced a recall for any reason.
The Company’s first face-to-face contact with FDA took place in March 2008, when an inspector came to call – the first FDA visit to Evanger’s Wheeling facility in thirteen years.
A New FDA Emphasis On Inspection
FDA’s current canned food regulatory system came into being in the early 1970’s, and was an agency success story for more than 30 years. Unfortunately, success sometimes breeds complacency. On July 18, 2007, Castleberry’s Food Company recalled its canned chili products, when four cases of botulism were linked to the Company’s canned chili. The recall was expanded on July 21st to encompass all of Castleberry’s canned foods, including pet foods.
Five months later, FDA received a second shock. Agency inspectors discovered that New Era Canning’s cut green beans presented a serious health risk, due to deficiencies in the Michigan Company’s canning operations. New Era recalled the green beans on December 21, 2007, and expanded the recall to include additional products in January 2008.
Prodded into action by the deficiencies that were revealed during the Castleberry’s and New Era investigations, FDA sent a Dear Colleague letter to all canned food processors on December 21, 2007. In the letter – issued on the same day as the first New Era recall – FDA reminded processors of their responsibilities under federal regulations. In addition, the agency stepped up its canned food inspection program.
Three months after FDA released its Dear Colleague letter, the agency sent an inspector to visit Evanger’s. During his visit, the FDA inspector pointed out several deviations to Joel Sher, many of which were corrected while the inspection was still in progress. The most significant issue – one that would require more time and outside expertise to correct – was the need to update the Company’s sterilization “Processes”, on file with FDA.
Because canned foods present an ideal environment for the growth of Clostridium botulinum and the development of the deadly toxin that causes botulism, FDA requires that canned food manufacturers validate their cooking processes for each individual recipe. Government regulations also are very specific in their requirements for equipment validation and record keeping.
The inspector who visited Evanger’s in March 2008 pointed out that the Processes then on file with the agency were outdated. Joel and Holly had modified some formulas and developed a new line of “hand-packed” canned foods. The Company needed to submit new validation data to cover the changes – and was required to operate under an Emergency Permit while its documentation was brought up to date.
Evanger’s Complies
Evanger’s hired two different experts in canned food process validation to bring its paperwork into full compliance. Thermal Process Technology took care of the hand-packed products, and TechniCal was handed the loaf-style canned food validation project.
TechniCal and Evanger’s went beyond the bare requirements for validation, deciding to base the loaf-style canned food process validation on the most difficult product to sterilize – the Vegetarian loaf-style. In addition to the standard process validations, Joel Sher instructed TechniCal to also validate the effectiveness of the Company’s canned food sterilization equipment – the retorts – in a “worst case scenario”.
Retorts are equipped with vents that are opened while steam is introduced into the chamber. The vents allow dry air to escape as the steam enters the retort, preventing the formation of air pockets that could result in inadequate sterilization. TechniCal, on instructions from Evanger’s, ran a test of the process without opening the vents. Even under those “worst case” conditions, the sterilization process was effective.
All of the work was completed promptly, and all of the validation data were in FDA’s hands by the end of August 2008. In order to tidy up Evanger’s process file, TechniCal also deleted the obsolete processes from the Company’s FDA file.
In fact, when eFoodAlert contacted FDA by email on December 2, 2008, we were told, “Evanger’s was issued a permit and is now operating in full compliance with applicable FDA regulations.”
Certain that the company had met all FDA requirements, Joel Sher planned to request the dismissal of the Company’s Emergency Permit during the next inspection, scheduled for March 2009. But that was not to be.
The Stumbling Block
As planned, the FDA inspector returned to Evanger’s in March 2009. On making his rounds, the inspector pointed out a couple of minor deviations, which were addressed immediately and noted on the inspection report. But, according to the inspector, TechniCal had made a mistake in its submission, on Evanger’s behalf, of the process validation data to FDA.
Instead of naming the validation process “All Loaf Style Solid Pack Products”, which would have covered the entire range of products, TechniCal named the process “Vegetarian”. Rather than simply allowing TechniCal to correct the process name, FDA decided to apply the letter of the law, and demanded that Evanger’s submit a separate process validation for each individual loaf style. And, two months after the inspection, FDA suspended Evanger’s Emergency Operating Permit – even though the Company was already working to comply with FDA’s demands.
Is Evanger’s Canned Pet Food Safe?
During our telephone conversation, I asked Joel Sher whether FDA had ever requested a product recall. “No,” he replied, “Absolutely not!”
Joel went on to explain that, if FDA was concerned about the safety of Evanger’s canned foods, the agency could have requested a recall, and could have asked Illinois to block sale of the canned food within the state. FDA took no such actions.
In response to my questions regarding the Company’s internal Quality Assurance program, and its commitment to product safety, Sher disclosed the following:
- Evanger’s processes all of its loaf-style pet foods based on the requirements for the toughest product to sterilize – the Vegetarian loaf. This provides an extra safety margin for all of the other products;
- Evanger’s has validated its sterilization equipment under worst-case scenarios, again ensuring a safety margin for normal operations;
- Evanger’s supplier of vitamin and mineral premixes maintains a Certificate of Analysis on file for each premix batch, and those Certificates are available to Evanger’s upon request;
- Evanger’s receives a Certificate of Analysis for each shipment of other specialty ingredients, such as guar gum;
- Evanger’s conducts incubation testing of each batch of canned food it produces; and
- Evanger’s conducts random sampling of its products for microbiological and nutritional profile testing, carried out by a reputable independent laboratory.
No manufacturer is immune from the occasional complaint from a dissatisfied customer. And Evanger’s is no exception. The Company tries to address complaints as they arise, but its efforts are not always successful.
One former customer, unhappy with Evanger’s response to her complaint that the Company’s dry dog food had made her dogs ill, took matters into her own hands. She arranged for a sample of Evanger’s dry food to be tested for copper, aflatoxins and solanine. The testing lab reported negative results for solanine (a natural toxin sometimes found in potato) and aflatoxins (toxins produced by some molds). The lab determined the level of copper to be 12.3mg/Kg (shown on the report as 1.23mg/100g).
The amount of copper found by the testing lab is nearly twice the minimum level (7.3mg/Kg) recommended by FDA for a dry dog food, but well within the maximum recommended level of 250mg/Kg. And despite the customer’s claim that a copper concentration of 12.3mg/Kg is excessive, other high quality dry dog foods routinely contain this much copper. Innova dry dog food, for example, typically contains 14.4mg/Kg.
What Happens Next?
Evanger’s has filed the required additional Process information with FDA, and has requested an informal hearing – set for June 23rd – to review its status. The Company expects their Permit suspension to be lifted shortly thereafter.
“Meanwhile,” Joel Sher reports, “Evanger’s continues to manufacture its high quality, nutritious, wholesome, innovative and safe products at its plant in Wheeling, Illinois.”
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