Evanger's Dog & Cat Food Company, Inc., whose canned food operation has been under FDA scrutiny for more than a year, learned yesterday that the federal agency was suspending the company's temporary emergency operating permit. FDA's action prevents Evanger's from selling its canned pet foods outside of its home state of Illinois.
FDA, in a notice released to the public yesterday evening, stated that Evanger's ". . . deviated from the prescribed process, equipment, product shipment, and recordkeeping requirements in the production of the company's thermally processed low acid canned food (LACF) products." The deviations, according to FDA, could result in under-processing, which could allow survival of Clostridium botulinum in the canned pet foods. Clostridium botulinum is a spore-forming bacterium that produces a deadly neurotoxin.
The story began in April 2008. After inspecting Evanger's food canning operations, FDA advised the company that the pet food maker would need to obtain an emergency operating permit in order to continue interstate distribution of its canned pet foods. The agency took this action due to "significant deviations" in the company's processes, equipment and documentation. The emergency permit would allow Evanger's to continue operating while correcting those deviations.
The company responded publicly to the April 2008 FDA action, claiming that the problem was a relatively minor documentation issue, that FDA's April 24, 2008 announcement was inaccurate and misleading, and that Evanger's was not operating under an emergency permit.
In June 2008, FDA issued Evanger's with a temporary Emergency Permit, under which the company could continue to operate while correcting the outstanding issues. The agency reinspected Evanger's between March and April 2009, and determined that the company was not operating in compliance with the conditions of the Emergency Permit. FDA, therefore, decided to suspend the permit until Evanger's shows that it has taken appropriate corrective actions to bring the company's processes into line with government requirements.
Evanger's released a statement today in response to FDA's actions. Joel Sher, the company's Vice President, blames the entire problem on an inadvertent documentation error on the part of Evanger's processing expert. The error, according to Sher, occurred in August 2008 and the company ". . . has been working with the FDA to resolve this issue quickly."
As FDA pointed out in a "Dear Colleague" letter to the Low Acid Canned Food industry in 2007, the agency's canned food regulations ". . . are among the best examples of science-based food safety regulations with long records of successful implementation." But this excellent track record requires diligent attention to careful process control and thorough process documentation – something that, apparently, has been lacking at Evanger's.
It's time for Evanger's to come out of "denial" and start cleaning up its act. It's not enough to use wholesome ingredients that are sourced in the United States. It's not enough to be the oldest natural pet food company in the United States. Evanger's customers have every right to expect the company to process its pet foods under the very best of Good Manufacturing Practices and in full compliance with FDA requirements.
Anything less is unacceptable.