Tag: FSIS

It is time to rebuild the US food safety system

Several weeks ago, food safety advocate Bill Marler launched his campaign to “Get the ‘F’ out of the FDA.”

Marler proposed that Congress split the Food and Drug Administration into two separate agencies—one with responsibility for food safety and human nutrition, and the other for drugs, cosmetics and medical devices.

While I agree with the need for a separate agency to oversee food safety and human nutrition, I believe Marler’s proposal does not go far enough.

It is time to consolidate all food safety activities at the federal level under a single umbrella.

Here’s why.

Split jurisdiction

At present, responsibility for overseeing food safety is split between two main federal agencies: the FDA and the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA).

The USDA is responsible for the safety of meat and poultry, catfish, and egg products.

The FDA is responsible for the safety of all food products that do not contain meat or poultry, for intact eggs, and for all fish other than catfish.

This division of responsibility by commodity has led to some strange and confusing situations.

  • canned foods containing meat or poultry come under FSIS jurisdiction, while all other canned foods are FDA-regulated.
  • pizzas containing more than 2% meat are the responsibility of FSIS; less than 2% meat, and the FDA takes over.
  • open-faced sandwiches containing meat are overseed by FSIS; closed sandwiches are the responsibility of the FDA, whether or not meat is present.

These arbitrary distinctions mean that many food processing plants must answer to two separate federal agencies.

Conflict of interest

The USDA operates under a double mandate.

On the one hand, it is responsible for certifying that the food products under its jurisdiction are safe for human consumption.

On the other hand, the USDA also is charged with promoting US agricultural products both domestically and to overseas markets.

This is akin to having the quality assurance department of a food company report to the head of the marketing department.

We have seen the consequences of this conflict most recently in the FSIS draft proposal to allow as much as one Salmonella per gram of chicken in raw, breaded stuffed chicken products. 

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An immodest proposal

It is time to demolish the current ineffective, wasteful, and conflicted system and build a new one, centered on a new Food Safety and Nutrition Agency (FSNA) with a seat at the Cabinet table.

The FSNA would take over all of the food safety and nutrition program activities currently performed by the FDA. In addition, all responsibility for meat, poultry, egg products and catfish would fall under the FSNA umbrella.

The USDA would retain responsiblity for certifying the fitness of livestock for slaughter and certifying the fitness of their meat for human consumption.

At the moment meat or poultry leaves the slaughterhouse, jurisdiction would shift to the FSNA.

This approach would have the benefit of eliminating the conflict of interest inherent in the USDA’s double mandate. It would also unscramble the arbitrary and confusing overlap of jurisdictions between the FDA and the FSIS.

The consolidation of all food safety responsibilities within a single, independent agency is not a new idea.

The Canadian Food Inspection Agency (CFIA) was created in 1997 by consolidating into a single agency the food safety components of the Health Protection Branch (then the Canadian equivalent to the FDA), the Department of Agriculture, and the Department of Fisheries and Oceans.

Other countries, including the United Kingdom, Australia, and New Zealand have followed a similar path.

The bottom line

Congress created the current dysfunctional structure over a span of many decades. 

Therefore, it is up to Congress to deconstruct this broken system and build a new one that will work to the benefit of the public it has been elected to represent.

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USDA has future plans to consider whether Salmonella in chicken should be dealt with

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

The USDA is beginning to consider whether or not to consider if Salmonella in poultry should be considered a problem.

The department’s Food Safety and Inspection Service (FSIS) today announced that it is “considering a regulatory framework” for a new strategy that would allow the agency to consider controlling Salmonella in poultry products. The goal, if things move forward, is to reduce human illnesses.

Every year at least 135,000 people are sickened by Salmonella, according to the Centers for Disease Control and Prevention. Of those illnesses, one-fourth are caused by the pathogen in chicken.

The potential framework described in the FSIS announcement has three prongs and an open ended time schedule.

Some who have been fighting for Salmonella to be declared an adulterant in poultry — making it illegal to sell chicken contaminated with it knowingly or unknowingly — are feeling lukewarm about the potential framework.

Bill Marler, a Seattle food safety attorney who three years ago filed a petition on behalf of several individuals and three consumer groups seeking to have Salmonella declared an adulterant, said the FSIS announcement reminded him of a 19970s TV commercial: “Where’s the beef?”

He said the proposal for a framework to consider studying the situation “dances around” the problem. He is concerned that the proposed framework is not bold enough. He is, however, glad to see some movement, any movement.

“This is the first public-facing document I’ve seen in more than 30 years that FSIS has put out there showing that they understand there is a problem,” Marler said.

Consumer Reports, one of the groups named in the petition filed by Marler, is also pleased at this first step by FSIS. The group said the announcement  “is an encouraging sign that the agency is stepping up its efforts to protect the public.

“Salmonella contamination is all too common in poultry and poses a potentially deadly risk to consumers,” said Brian Ronholm, director of food policy at Consumer Reports. “It’s critical for the USDA to work expeditiously to adopt aggressive goals to sharply reduce Salmonella contamination and focus its efforts on reducing the strains that pose the biggest threat to human health.”

The citizen’s petition asked FSIS to declare 32 strains of Salmonella to be considered an adulterant. The FSIS is considering whether to review three of those strains.

Salmonella contamination is widespread in chicken in part because of the often crowded and filthy conditions in which they are raised, according to Consumer Reports. A recent CR investigation, for example, found almost one-third of ground chicken samples tested contained Salmonella. 

Consumer reports said the numbers are alarming and that the framework needs to go further.

“While the USDA currently requires producers to test poultry for Salmonella, a processing facility is allowed to have the bacteria in up to 9.8 percent of all whole birds it tests, 15.4 percent of all parts, and 25 percent of ground chicken. Producers that exceed these amounts are given what amounts to a warning, but not prevented from selling the meat,” according to the Consumer Reports statement.

By the FSIS’s own admission the number of illnesses caused by Salmonella in poultry has remained stagnant for decades. This is in the context that industry has reduced the amount of Salmonella found in poultry by 50 percent. Marler explained that anomaly in terms of a swimming pool.

“If you have a pool and you drain out half of the water you still have half a pool of water,” he said.

The water in the pool represents the amount of Salmonella in the chicken. There’s just too much of it left, even with the 50 percent of it gone, that makes people sick. That shows how much Salmonella is in chicken — too big of a bacterial load, as scientists say.

With the proposed FSIS framework the number of human illnesses caused by Salmonella in poultry would be decreased by 25 percent, meaning three out of four people who are sickened would still get sick. That is not acceptable in Marler’s opinion. 

The Center for Science in the Public Interest (CSPI) is pleased to see the attention to Salmonella in poultry but is cautiously optimistic.

“While the proposed framework represents a welcome shift in thinking by the agency, many important details are yet to be worked out, and the need for these changes is urgent,” CSPI said in a statement this morning.

“USDA’s announcement of this framework represents a landmark acknowledgment from an agency that has long refused to recognize that Salmonella in raw poultry poses unacceptable risks. Center for Science in the Public Interest first petitioned the USDA to ban certain strains of antibiotic-resistant Salmonella in 2011, and again in 2014, but was denied twice by the agency.”

STOP Foodborne Illness is also happy to see some action out of FSIS on the decade-old problem of Salmonella in chicken.

“Stop Foodborne Illness (STOP) applauds FSIS for taking the first step of developing meaningful, comprehensive controls for Salmonella in poultry that includes an enforceable final product standard. The proposed framework reflects many issues raised by STOP and its coalition partners in our joint petition filed in January 2021,” said Mitzi D. Baum, M.Sc. and CEO of STOP.

One key point in the proposed framework for the possible FSIS strategy for dealing with Salmonella in poultry is to have the industry work out the problem. The framework calls for birds to come into “the establishments” cleaner. That means that people who raise chickens would have to send healthy birds to slaughterhouses and processing plants.

By putting pressure on “the establishments” to accept cleaner birds the government believes the slaughterhouses and processors would put pressure on their suppliers, thus resolving the problem.

Marler says the most significant point in the proposed framework is that it recognizes that dealing with Salmonella pre-harvest is necessary. Right now there is no industry incentive to fix the problem.

Consumer Reports agrees that testing so-called incoming birds is a crucial step.

“Under the proposal announced by the USDA, poultry producers would be required to test flocks for Salmonella before slaughter and provide documentation on Salmonella levels or serotypes to processing plants,” according to Consumer Reports’ statement. “The requirement is meant to incentivize plants to implement measures to reduce the Salmonella load in the final poultry product. USDA is also considering the adoption of a final product standard to ensure that poultry contaminated with Salmonella likely to make people sick is not allowed on the market.”

The framework itself 

A key point from the FSIS announcement is that the agency will be seeking comment from stakeholders on all of the elements of the framework —  both at a public meeting and in written comments submitted to the meeting docket in the Federal Register — before moving forward with any proposed changes to regulations or other actions.

After analyzing recent data on human illness from the Centers for Disease Control and Prevention and FSIS sampling results from chicken and turkey products, the agency has decided to focus at this time on three serotypes: Enteritidis, Typhimurium, and Infantis, which together cause 33 percent of all Salmonella illnesses. The public petition requested that 32 types be considered adulterants.

Excerpts from the three components of the framework

Component 1: Requiring incoming flocks be tested for Salmonella before entering an establishment

FSIS is considering requiring establishments to characterize Salmonella as a hazard reasonably likely to occur at receiving and that incoming flocks be tested for Salmonella before entering an establishment. 

Under this approach, the flock would have to meet a predetermined target for Salmonella at receiving, which may be industry-wide or establishment-specific, and the establishment must demonstrate that its subsequent process will be effective in reducing Salmonella so that the product will meet the final product standard. 

Salmonella enters an establishment in and on the birds. The goal of this component is to incentivize the use of pre-harvest interventions that reduce the level of incoming Salmonella contamination or mitigate the risk of a particular serotype entering the establishment.

Under this approach, FSIS does not intend to require the industry to adopt any specific pre-harvest interventions but would allow flexibility for the industry to adopt the practices that are most effective at controlling Salmonella in each particular operation. Establishments would be encouraged to work with their suppliers and contractors to ensure they are implementing best practices in reducing the Salmonella hazard in breeding facilities, hatcheries, grow-out and throughout transport.

Component 2: Enhanced Establishment Process Control Monitoring and FSIS Verification 

To ensure that poultry slaughter establishments are effectively controlling Salmonella throughout their operations, FSIS may propose to modify its current regulations to prescribe enhanced establishment monitoring procedures, including revised locations for multipoint sampling and the use of a statistical approach to process control.

The second component of this proposed framework builds on Hazard Analysis and Critical Control Point (HACCP), FSIS’ prevention-based approach to food safety. To ensure pathogen control throughout slaughter and processing operations, FSIS may modify the existing requirements for indicator organism testing for process control and establish additional parameters to better define the required analysis of the data. As part of the proposal, establishments may be required to test for indicator organisms (e.g., aerobic plate count [APC], Enterobacteriaceae).

Component 3: Enforceable Final Product Standard

FSIS is assessing whether certain levels or types of Salmonella in raw poultry products present an elevated risk of causing human illness such that they should be considered adulterants. As a result, the agency is considering implementing a final product standard or standards to ensure that product contaminated with Salmonella that is likely to make people sick is not sold to consumers. 

To protect public health, FSIS regulations should prevent products with high levels of contamination and/or specific serotypes from entering commerce. This goal would be accomplished by declaring Salmonella an adulterant. In doing so, FSIS would rely on criteria that were applied to STECs. These criteria are: consideration of serotypes associated with human illness; low infectious dose; severity of human illnesses; and typical consumer cooking practices.

(Editor’s note) The reference to STECs, or Sign toxin-producing E. coli, relates to how the beef industry was forced to clean up its meat when E. Coli was declared an adulterant.

Consistent with its approach to determining the status of certain STECs as adulterants in specific raw beef products, FSIS is considering whether there are specific Salmonella and raw poultry product pairs that have characteristics that distinguish them from other raw poultry products contaminated with Salmonella, such that Salmonella at certain levels and/or types of Salmonella should be considered as an adulterant when present in that specific raw poultry product. 

For example, FSIS will soon be releasing a proposal that Salmonella meets the criteria to be considered an adulterant in not-ready-to-eat (NRTE) breaded and stuffed raw chicken products, an action that will allow the Agency to better protect public health. 

At the same time, FSIS is exploring if a single product standard for Salmonella in all raw poultry products may be appropriate. From a consumer’s perspective, exposure to a quantity and/or serotype of Salmonella likely to make them sick is a key risk factor for the illness that may be consistent across product types. 

Seeking public comment

FSIS is soliciting input on all aspects of the draft framework, related to the three components as well as the cross-cutting issues. An online copy of the proposed framework is available at: www.fsis.usda.gov/inspection/inspection-programs/inspection-poultry-products/reducing-salmonella-poultry/proposed.

Food Safety Administration: A too-modest proposal

Senator Richard Durbin (D-IL) and Representative Rosa DeLauro (D-CT) have proposed bicameral legislation to split the US Food and Drug Administration (FDA) into two separate entities: the Food Safety Administration (FSA) and the Federal Drug Administration.

The new Food Safety Administration would remain a part of the US Department of Health and Human Services and would be led by a food safety expert whose appointment would require Senate confirmation.

The proposed restructuring of the FDA came in response to agency shortcomings revealed during the recent Abbott Nutrition infant formula recalls and investigations.

Divide and conquer

While the intentions of Senator Durbin and Congresswoman DeLauro are to be lauded, I believe their proposed solution does not address a major underlying flaw in the US food safety regulatory system.

I am referring to the divided and overlapping jurisdictions of the current FDA and the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture.

As now constituted, the FDA is responsible for ensuring the safety of approximately 80% of the US food supply. The FSIS oversees most of the balance, including meat, poultry, eggs and siluriformes (catfish and other related species).

This split jurisdiction has led to some strange and arbitrary divisions of authority. For example, the USDA oversees inspection of open-faced sandwiches containing meat or poultry, while the FDA is responsible for all other open-faced sandwiches as well as for all closed-face sandwiches, regardless of the filling.

Pizzas containing more than 2% meat are regulated by the FSIS; other pizzas come under the purview of the FDA.

As I wrote in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, “[a] fragmented inspection system is expensive, inefficient and unfair to the industry it regulates.”

In addition to the jurisdictional jigsaw puzzle, the FSIS is in a potential conflict of interest vis-à-vis other agencies within the USDA that are responsible for marketing US food commodities domestically and around the world.

Show me the money

The combined discretionary food safety budget allocated to FSIS and the current FDA for 2022 is $2.766 billion.

The FDA’s share of this budget is $1.6 billion, or ~58% of the total amount.

Yet, the FDA is responsible for regulating ~80% of the food supply. The Durbin/DeLauro proposal does nothing to address the funding imbalance between the two principal federal food safety agencies.

In 1998, a joint committee of food safety experts within the US Institute of Medicine and the National Research Council recommended that the US consolidate food safety into a “single, unified agency headed by a single administrator.“

Several US trading partners have done just that.

Canada, the United Kingdom, Ireland, Australia, New Zealand and Denmark, to name just a few, have successfully consolidated their food safety programs. In doing so, these countries have reduced duplication of efforts, streamlined jurisdictions, and removed the appearance of a conflict of interest between agricultural marketing and food safety.

The solution

The United States should have taken the advice of its own experts decades ago.

Representative DeLauro and Senator Durbin, the US food safety system is badly broken. What you are proposing is to apply a Band-Aid when what is needed is an organ transplant.

Instead of splitting the current FDA into two separate components, you should be proposing a single, unified, stronger Food Safety Administration. One with enough muscle to claim a seat at the cabinet table.

It’s time to “go big or go home.”

Learn more about a variety of food safety issues in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.

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“Reads like a true crime novel” – Food Safety News