In case anyone hasn’t yet figured it out, the Mandatory Recall Authority that Congress granted FDA under the Food Safety Modernization Act was responsible for Kasel’s ‘voluntary’ recall of Salmonella-contaminated pet treats.
Earlier today, FDA released the letter in which the agency threw down its gauntlet and demanded that Kasel Associates Industries, Inc. recall contaminated pet treats. The February 13, 2013 “Notification of Opportunity to Initiate a Voluntary Recall”, was hand-delivered to Raymond J. Kasel. The letter stated the basis for FDA’s determination that “…there is a reasonable probability that the affected pet treats are adulterated under section 402(a)(1) and (a)(4) of the FD&C Act and that there is a reasonable probability that the use of or exposure to the pet treats will cause serious adverse health consequences or death to humans or animals…” A sampling of the findings include:
- Multiple finished product samples of Kasel pet treats obtained by the State of Colorado’s Department of Agriculture in September and October 2012, were tested and subsequently found to be positive for Salmonella.
- In response to the state of Colorado’s Salmonella-positive results, FDA conducted an inspection of Kasel’s manufacturing facility from September 19-28, 2012. During the inspection, the FDA investigators collected various samples for further testing, including bulk and finished product samples and numerous environmental samples. Many of these samples tested positive for Salmonella.
- Salmonella is a pathogenic organism that can cause serious adverse health consequences or death in humans and animals. The presence of Salmonella in pet food can pose a particularly acute health risk to children and people who are elderly or immunocompromised.
- [E]vidence collected by FDA and the state of Colorado, including environmental and product samples collected and analyzed by Colorado and the FDA, and observations made by FDA during the inspection of [Kasel], establishes the following:
- Pet treat products manufactured, processed, packed, or held by [Kasel] from April 20, 2012, through September 19, 2012, are contaminated with Salmonella, or are at risk for contamination with Salmonella, based on the conditions in your facility and multiple Salmonella-positive results from environmental samples, including positive results on food contact surfaces within your facility, and from samples of your finished product. Test results indicate there are more than a dozen different Salmonella serotypes in your firm’s manufacturing facility and finished products. In addition, the test results indicate that various Salmonella positive samples from finished products are serotype matches to, and in some cases share a Pulsed Field Gel Electrophoresis (PFGE) pattern with, other finished products and/or various environmental swabs taken at the facility during the September 2012 inspection. Due to this widespread Salmonella contamination and/or risk of contamination, FDA has determined that there is a reasonable probability these products are adulterated under section 402 of the FD&C Act and there is a reasonable probability that the use of or exposure to these pet treats will cause serious adverse health consequences or death to humans or animals.
- [Kasel] created, caused or was otherwise responsible for this reasonable probability of adulteration: under section 402 of the FD&C Act. Specifically, FDA has determined that the conditions within your facility (e.g., the presence of Salmonella in various locations throughout the facility and multiple sanitation deficiencies) that could lead to cross contamination between raw materials and finished products caused the reasonable probability.”
The letter, which was signed by Michael R. Taylor (FDA’s Deputy Commissioner for Foods and Veterinary Medicine), demanded action within two (2) business days of its receipt by Mr. Kasel, and concluded with the following two statements:
“If you do not voluntarily cease distribution and conduct a recall in the time and manner described in this section, FDA may, by order, require you to immediately cease distribution of the affected pet treats. Additionally, FDA may, by order require you to immediately notify all persons manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling the affected pet treats to immediately cease distribution of such articles; and to immediately notify all persons to which such articles have been distributed, transported, or sold, to immediately cease distribution of the affected pet treats.”
“If a response is not received from you within two (2) business days of your receipt of this letter, FDA may by order require you to immediately cease distribution and notify applicable parties, as explained above.”
The food and pet food industries are now on notice. FDA is ready, willing and able to use its mandatory recall authority to achieve the removal of dangerously contaminated food and pet food from the marketplace.