On April 25, 2023, the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA) proposed its first ever limit on the level of Salmonella in raw chicken.

Under the new proposal, the chicken ingredient used in the manufacture of breaded, stuffed raw chicken products must not contain more than one live Salmonella per gram of chicken.

The FSIS will consider any breaded, stuffed raw chicken product to be adulterated if it is manufactured using a chicken ingredient that exceeds the one-per-gram limit.

The proposed limit does not apply to other forms of breaded raw chicken products, such as nuggets, patties, or chicken fingers.

The details will be published in the Federal Register, and the public will have a 60-day period in which to provide comments on the new proposal.

Why now?

In 1998-2020, the FSIS carried out 178 Salmonella outbreak investigations associated with raw and cooked chicken products. Fourteen of them involved breaded, stuffed raw chicken products.

According to statistics cited in the draft proposal, breaded stuffed chicken products accounted for less than 0.15% of the total US chicken supply, yet were associated with approximately 5% of all chicken-associated outbreaks in the United States.

In 2006, following a series of outbreaks, the FSIS urged the poultry industry to modify the labeling on packages of breaded, stuffed chicken products to emphasize to consumers that these products are, in fact, raw and that they must be cooked to an internal temperature of 165º.

That same year, the FSIS issued guidance to consumers regarding safe cooking practices for these products.

Nevertheless, additional outbreaks occurred in 2008-2009, 2013, 2014, 2015-2016, and 2021, leading the FSIS to propose this new policy approach.

In a Letter to the Editor of Food Safety News, Consumer Reports expressed its support for the initiative.

Conversely, the National Chicken Council has voiced its opposition to the proposed policy change.

According to reporting by Food Safety News, the Council raised concerns regarding economic impacts, job losses, and an “abrupt shift” in longstanding policy—a shift that the industry group claimed was not science-based.

Impact on food safety

The USDA argues, based on anticipated portion size and the expectation that at least some of the Salmonella will be killed when the raw chicken products are cooked, that their proposed limit “…should significantly mitigate the risk of illness…” associated with the raw, breaded stuffed chicken products.

But other countries have chosen a different path.

In the past, Canada also struggled with repeated outbreaks of Salmonella associated with raw, breaded chicken products.

On April 1, 2019, the Canadian Food Inspection Agency (CFIA) implemented a new policy designed to reduce the risk of Salmonella illnesses associated with these products.

That policy included a “zero tolerance” for Salmonella in a 125g sample of the raw chicken mix used to manufacture the targeted products.

This specification is 125 times as stringent as the proposed USDA limit.

There have been no reported outbreaks of Salmonella in Canada linked to consumption of raw, breaded chicken products manufactured since the new policy took effect.

In the United Kingdom and member countries of the European Union, the detection of Salmonella in any raw poultry product—intact, ground, and/or breaded—is grounds for initiating a product recall.

When viewed against the backdrop of European and Canadian policies, the proposed USDA approach is barely a first baby step in the direction of mitigating the risk of Salmonella outbreaks linked to raw, breaded stuffed chicken products.

And this new policy will have no effect at all on the risk of Salmonella infections from other raw poultry, whether due to undercooking or cross-contamination.

By the numbers

In its draft proposal, the USDA acknowledges that infective doses as low as from 1 to 420 Salmonella organisms per person have caused illnesses in previous outbreaks, with a median dose of 36 Salmonella per person.

At a permitted level of one Salmonella per gram, a 3-ounce (85g) portion of breaded stuffed chicken would contain, in theory, 85 Salmonella cells before cooking. 

If the product is allowed to thaw and remain at or above room temperature before cooking, either in the car or in the home, these numbers will increase.

The best way to ensure that temperature abuse does not lead to a dangerous level of Salmonella is to start with as clean a slate as possible. 

In this context, a limit of one Salmonella per gram is a recipe for disaster.

Faulty focus

The USDA has limited its proposal to breaded, stuffed raw chicken products, arbitrarily exempting all other breaded raw chicken products—indeed, all other raw poultry—from any limitation on the presence of Salmonella in the product.

This is a mistake. There is absolutely no scientific or epidemiological basis for this decision.

Canada, too, has made a similar error. While the Canadian “zero-tolerance” policy is far more stringent than the proposed USDA approach, the CFIA has limited that policy to breaded raw chicken products that are NOT stuffed, exempting all other raw poultry from this Salmonella control measure.

Neither country has adopted Salmonella-control measures that would reduce the risk of cross-contamination due to raw poultry in the kitchen.

It is time for both countries to face the reality that the presence of Salmonella in any raw poultry meat represents a significant health hazard to the general public and must be addressed at the source.

The time for baby steps is over.

---

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

TAINTED is available in digital format from all major on-line retailers. Press the button to go directly to your preferred digital bookstore.

This story by Coral Beach first appeared in Food Safety News and is reposted here with permission.

Three of FDA’s former food safety chiefs have come together today to submit comments to a U.S. House of Representative’s oversight committee focused on chain of command problems at the agency.

The former Food and Drug Administration officials who submitted the comments to the U.S. House of Representatives Subcommittee on Health Care and Financial Services for the Committee on Oversight and Accountability are:

• Stephen Ostroff, M.D., Former FDA Deputy Commissioner for Foods and Veterinary Medicine and Acting Commissioner 2016-2018;
• Michael R. Taylor, Former FDA Deputy Commissioner for Foods and Veterinary Medicine 2010-2016;
• David Acheson, M.D., Former FDA Associate Commissioner for Foods 2007-2009.

While the comments submitted to the committee’s official record are made in the context of the 2022 infant formula crisis, which shed light on communication problems at the FDA, they focus on the overall problem of a lack of a clear chain of command for the agency’s foods program.

“The infant formula events are one sign that FDA has not accomplished the food safety transformation FSMA (the Food Safety Modernization Act of 2011) envisioned and is not organized for success on food safety, but there are many others,” the former FDA food safety leaders say in their comments. 

“The problems begin with the program’s low priority in the FDA commissioner’s office and include its fragmented organizational structure, insular culture, bureaucratic infighting, slow decision making, and failure to follow through on FSMA implementation.”

The comments repeatedly refer to the current FDA Commissioner Robert Califf and his apparent lack of willingness to effectively overhaul the food side of the FDA. The three former officials say Califf presides over an effective drug side of the agency, but they disagree with the commissioner’s handling of recommendations from an expert panel on how to make the food side of the agency work to ensure food safety.

“. . . they (the panel of experts) called for FDA to unify the program under a single leader with full line management authority to lead its essential culture change and program modernization,” the three former FDA deputy commissioners say in their comments.

“Inexplicably, FDA leadership has rejected this recommendation. . . Even more critically, the Deputy Commissioner for Human Foods (planned by Califf) does not even have authority over all of FDA’s human food components. That is because the large field-based units within FDA that manage food inspections, field laboratories, and import oversight – and consume some two-thirds of FDA’s food-related budget – remain organizationally separate, with no direct management accountability to the new deputy commissioner.”

The former FDA deputy commissioners say that Califf is focused on operations of the drug side of the agency — even though the FDA is responsible for more than 80 percent of the American food supply. They say the commissioner keeps pushing for an unrealistic option for the operation of the food side of the agency.

“The matrix management approach Dr. Califf touts from his private sector experience has been tried and failed at FDA, as we know from our personal experience and as exemplified by the lags in FDA’s action on infant formula,” according to the comments submitted to the committee hearing record.

“It is unclear why FDA leadership has rejected the recommendations of its stakeholders and independent experts who have deep experience and expertise on food matters.  One possibility is that, while the agency’s top leaders are highly expert in medical product oversight, they lack personal experience and expertise on food safety and what it will take to transform the Food Program’s culture and performance.

“Medical products certainly deserve all the attention they get at FDA, and for years that’s been the focus of FDA’s top leadership, which helps explain why food regulation has a lower priority within FDA and is chronically underfunded.  The focus of FDA leadership on medical products may also explain why the commissioner’s proposed reorganization of the Food Program is patterned after the model that works for drugs and other medical products but won’t work for food.”

The three former FDA deputy commissioners say quick action is required to ensure the safety of the country’s food supply and that Congress should step in if Commissioner Califf fails to take appropriate action.

“Ideally, the Commissioner would change course and replace the announced reorganization with one that truly unifies the Food Program and empowers the new deputy commissioner position.  Absent that, Congress must act by directing FDA to make these critical changes.  Or Congress could elevate and reset the Food Program by removing food from FDA altogether and creating a separate agency under a Commissioner for Food Safety and Nutrition,” the former deputy commissioners say. 

“With decisive action now, Americans can get the unified, efficient and forward-leaning food program they deserve and expect. With half steps, disunity and dysfunction that was so evident during the infant formula crisis will persist and history will surely repeat itself.”

---

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

TAINTED is available in digital format from all major on-line retailers. Press the button to go directly to your preferred digital bookstore.