WASHINGTON — The US Food and Drug Administration (FDA) has published a set of frequently asked questions and answers for manufacturers, retailers and distributors of pig ear pet treats following a widespread Salmonella outbreak in the US that affected 154 people across 32 states.

Pet Food Processing spoke with the FDA’s Center for Veterinary Medicine (CVM) about the Q&A, which addresses most of the questions the agency has received from the industry so far on the subject of pig ear pet treat safety.

“FDA urges firms to remain vigilant about taking measures to control pathogens such as Salmonella, and to conduct regular assessments, such as testing, to verify the effectiveness of their processing and the safety of their products,” comments Dr. Steven Solomon, DVM, MPH, director of the CVM.

What should suppliers/retailer do in order to resume selling pig ears?

The FDA suggests companies along the pig ear pet treat supply chain take extra precautionary measures to ensure product is not contaminated through environmental factors, handling or cross-contamination.

For example, retailers who held product in storage during the outbreak are advised to process them further before offering them on the market, especially those that were imported. During the investigation, several pig ear products found to be contaminated with Salmonella were sourced from Argentina, Brazil and Columbia.

The agency issued an Import Alert (72-03) to inform suppliers and distributors about potential risks with the imported products and lay out guidance for vetting those products for the US market. The FDA said it was unable to discuss specific compliance or enforcement strategies.

Traceability was also an issue, as the FDA found contaminated product difficult to trace in some cases where it had been mixed with other product in bulk bins at the point of sale. “Retailers should be aware that selling bulk product or commingling unwrapped product can lead to cross-contamination and impact traceability,” the agency states.

The FDA also reported some pig ear treats tested positive for Salmonella even after being individually packaged and irradiated. It reminds suppliers to consider pathogen contamination levels, water activity, and the possibilities of post-processing recontamination during cooling and packaging to prevent contamination.

“Whether choosing irradiation or another pathogen control method such as baking, suppliers should ensure that their processes and conditions are validated and verified as effective on their specific equipment and for the particular product,” the FDA says.

What responsibilities do manufacturers and suppliers have in controlling for Salmonella?

For firms subject to Food Safety Modernization Act (FSMA) regulations, upholding rules for Preventive Controls for Animal Food and validating the effectiveness of their contamination control processes will help manufacturers and suppliers mitigate Salmonella risk, the FDA says.

Additionally, companies not subject to FSMA requirements, as well as importers of animal food products, are expected to keep adulterated products off the market. The FDA refers importers to its Foreign Supplier Verification Program, which holds them accountable to food safety standards that match those followed by US manufacturers and suppliers.

What can retailers do to make sure their suppliers are controlling for Salmonella?

Understanding suppliers’ contamination control methods and asking that they provide details about those processes is one way retailers can ensure product is safe for shelves, the FDA says. This includes compliance with Preventive Controls for Animal Food regulations, as well as providing information on the methods used for and proof of effective and consistent elimination of pathogens. 

Is properly performed irradiation effective at removing Salmonella from pig ears?

The FDA recognizes irradiation as a safe and effective way to prevent pathogen contamination in animal food and treat products but warns manufacturers to consider the effectiveness and potential risks associated with irradiating particular products.

Irradiation is the “ionizing radiation for treatment of animal diets,” as defined by the agency. Although it is proven to be effective, the FDA says it does not require or recommend it over other methods of pathogen control.

What should retailers and distributors do with product held in their procession at the time the outbreak was announced? Can they ship pig ears for further processing, like irradiation and packaging? 

If a product held by a retailer or distributor was recalled by the agency as part of the Salmonella outbreak investigation, the FDA advises them to either dispose of the product or submit it to the agency for reconditioning.

Products held by retailers and distributors that were not recalled do not need to be reconditioned or disposed of and may be sold and distributed. However, the FDA suggests companies take necessary steps to ensure those products are safe.

There is no cost associated with submitting a reconditioning plan to the FDA, the agency says.

“Pig ears previously irradiated in accordance with 21 CFR 579.22 cannot be re-irradiated. However, further processing using other methods that can eliminate Salmonella may be an option,” the FDA adds.

Does FDA “approve” or otherwise verify suppliers and/or the effectiveness of their processes? 

The agency says it will oversee and verify processes in cases where reconditioning plans have been submitted. Otherwise, the agency regulates food safety plans for pathogen control as part of FSMA, in which the responsibility falls on suppliers and manufacturers of the animal food products.

Why did FDA advise retailers not to sell any pig ears?

As previously mentioned, some retailers mixed several brands of pig ear pet treats into the same bulk bins, making it difficult to identify product that caused the contamination from product that became cross-contaminated at the point of sale, the agency explains.

Additionally, some products were packaged with limited labeling that did not include country of origin or irradiation status. The FDA says it was concerned about the ability of consumers and retailers to clearly identify safe product from potentially contaminated product as a result.

“We believe that the outbreak and the agencies’ response has increased awareness among industry and consumers of the potential for pig ear pet treats to be contaminated with Salmonella, the transmission of Salmonella to people and animals, and the need for industry to take steps to address this potential for contamination. Now that the outbreak has abated, we reiterate industry’s responsibility to ensure that product introduced to the market is not contaminated,” the FDA states.

Where did contaminated product come from?

FDA identified positive product associated with the outbreak that originated from Argentina, Brazil and Colombia. However, in the course of the investigation, the agency also identified US product that tested positive for Salmonella and were subsequently recalled. Although the strain of Salmonella found in the US product did not match the outbreak strain, the FDA urges domestic manufacturers and suppliers, as well as foreign importers, retailers and distributors, to ensure products are free of pathogens and other contaminants that pose risks to human and animal health. 

What is FDA doing on this issue going forward?

The agency says it “is continuing to monitor the marketplace as new product is introduced but cannot discuss specific compliance or enforcement strategies… The agency will take actions as appropriate to address contaminated product.”

For imported products, Import Alert 72-03 remains in place and will be updated accordingly as more product is tested.

The Q&A was posted on Oct. 30, the same day it and the Centers for Disease Control and Prevention (CDC) announced the outbreak appeared to be over.

Read more about the suppliers, manufacturers, retailers and distributors involved in this recent Salmonella outbreak linked to pig ear pet treats and the timeline of the investigation.

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