Kerry Inc. Pleads Guilty and Agrees to Pay $19.228 Million in Connection with Insanitary Plant Conditions Linked to 2018 Salmonella Poisoning Outbreak

I need to update my slide deck:

Food and ingredient manufacturing company Kerry Inc. pleaded guilty today to a charge that it manufactured breakfast cereal under insanitary conditions at a facility in Gridley, Illinois, that was linked to a 2018 salmonellosis outbreak.

Pursuant to a plea agreement filed with a criminal information in federal court in Peoria, Illinois, Kerry pleaded guilty to a misdemeanor count of distributing adulterated cereal marketed as Kellogg’s Honey Smacks. The company also agreed to pay a criminal fine and forfeiture amount totaling $19.228 million. If the guilty plea is accepted by the court, the $19.228 million fine and forfeiture will constitute the largest-ever criminal penalty following a criminal conviction in a food safety case.

“Consumers depend on food manufacturers to take appropriate steps to ensure food safety,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division. “The Department is committed to holding accountable those who fail to meet this obligation.” 

“Today’s announcement should serve as a reminder that food manufacturers have a critical responsibility to produce and sell food that is safe for American consumers to eat,” said Assistant Commissioner Justin D. Green for the Food and Drug Administration’s (FDA) Office of Criminal Investigations. “We will continue to pursue and bring to justice those who put the public health at risk by allowing contaminated foods to enter the U.S. marketplace.” 

The criminal information unsealed today alleges that Kerry manufactured Kellogg’s Honey Smacks cereal under insanitary conditions and distributed it in violation of the Food, Drug, and Cosmetic Act. According to the plea agreement, tests performed as part of Kerry’s environmental monitoring program found numerous instances of Salmonella in the environment at the Gridley facility. During the time period June 2016 to June 2018, routine environmental tests detected Salmonella in the plant approximately 81 times, including at least one positive Salmonella sample each month. According to the plea agreement, employees at the Gridley facility routinely failed to implement corrective and preventative actions (CAPAs) to address positive Salmonella tests.

In June 2018, the FDA and the Centers for Disease Control and Prevention (CDC) announced that an ongoing outbreak of salmonellosis cases in the United States could be traced to Kellogg’s Honey Smacks cereal produced at Kerry’s Gridley facility. In response, Kellogg’s voluntarily recalled all Honey Smacks manufactured at the plant since June 2017. The CDC eventually identified more than 130 cases of salmonellosis linked to the outbreak, with illness onset dates beginning in March 2018. The CDC did not identify any deaths related to the outbreak.

Salmonellosis can cause symptoms such as diarrhea, fever, and abdominal cramps that last several days in healthy adults. Absent prompt treatment, salmonellosis can cause severe dehydration and even death in infants, young children, the elderly, transplant recipients, pregnant women, and individuals with weakened immune systems.

In a related case, Ravi K. Chermala, Kerry’s Director of Quality Assurance until September 2018, previously pleaded guilty to three misdemeanor counts of causing the introduction of adulterated food into interstate commerce. Chermala oversaw the sanitation programs at various Kerry manufacturing plants, including the Gridley facility. In pleading guilty, Chermala admitted that between June 2016 and June 2018, he directed subordinates not to report certain information to Kellogg’s about conditions at the Gridley facility. In addition, Chermala admitted that he directed subordinates at the Gridley facility to alter the plant’s program for monitoring for the presence of pathogens in the plant, limiting the facility’s ability to accurately detect insanitary conditions. Chermala is scheduled to be sentenced on Feb. 16.

The court set a March 14 sentencing date for Kerry. Further information about the Kerry and Chermala cases will be posted to the Department’s Information for Victims in Large Cases website at https://www.justice.gov/largecases.

FDA’s Office of Criminal Investigations is investigating the matter.

Senior Trial Attorney James T. Nelson of the Civil Division’s Consumer Protection Branch is prosecuting the case. Former Trial Attorney Cody Matthew Herche and Associate Chief Counsel Jason Hadges of FDA’s Office of Chief Counsel provided substantial assistance.

For more information about the enforcement efforts of the Consumer Protection Branch, visit the Branch’s website at http://www.justice.gov/civil/consumer-protection-branch

Look what’s in the Federal Register – https://www.federalregister.gov/documents/2022/11/18/2022-25140/expansion-of-fsis-shiga-toxin-producing-escherichia-coli-stec-testing-to-additional-raw-beef

Not sure why this is not in a press release – but as my friends “down under”say: “Good on ya mate.”

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is announcing that on February 1, 2023, the Agency will expand its routine verification testing for six Shiga toxin-producing Escherichia coli that are adulterants (non-O157 STEC; O26, O45, O103, O111, O121, or O145), in addition to the adulterant Escherichia coli ( E. coli) O157:H7, to ground beef, bench trim, and other raw ground beef components in addition to raw beef manufacturing trimmings in official establishments. The raw ground beef components to be tested for these six non-O157 STEC, hereafter “other raw ground beef components,” are: head meat, cheek meat, weasand (esophagus) meat, product from advanced meat recovery (AMR) systems, partially defatted chopped beef and partially defatted beef fatty tissue, low temperature rendered lean finely textured beef, and heart meat. Currently, FSIS tests only its beef manufacturing trimmings samples for these six non-O157 STEC and E. coli O157:H7. Otherwise, all other raw beef products are tested only for E. coli O157:H7 and Salmonella.FSIS also will begin testing for these non-O157 STEC in ground beef samples that it collects at retail stores and in applicable samples it collects of imported raw beef products. Additionally, FSIS is responding to comments regarding the STEC testing expansion and the costs and benefits analysis (CBA), as well as its updated STEC laboratory testing criteria for determining whether a result is positive.

DATES:

Beginning February 1, 2023, FSIS will implement routine verification testing for the six additional STECs discussed in this document (O26, O45, O103, O111, O121, and O145) in raw ground beef, bench trim, and other raw ground beef components. At this time, FSIS also will implement testing for these non-O157 STEC in ground beef samples that it collects at retail stores and in applicable samples it collects of imported raw beef products.

FOR FURTHER INFORMATION CONTACT:

Rachel Edelstein, Assistant Administrator, Office of Policy and Program Development by telephone at (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

On June 4, 2020, FSIS announced in the Federal Register its plans to expand its routine verification testing for six non-O157 STEC (O26, O45, O103, O111, O121, or O145) that are adulterants in applicable raw beef products, in addition to the adulterant E. coli O157:H7, to ground beef, bench trim, and other raw ground beef components for samples collected at official establishments (85 FR 34397). FSIS also announced that it would test for these non-O157 STEC in ground beef samples that it collects at retail stores and in applicable samples it collects of imported raw beef products. FSIS stated that it would announce the date for implementation of the new testing in a subsequent Federal Register notice. Additionally, FSIS responded to comments on the November 19, 2014, Federal Register notice titled, “Shiga Toxin-Producing Escherichia coli (STEC) in Certain Raw Beef Products (79 FR 68843).” FSIS also made available its updated CBA on the implementation of its non-O157 STEC testing on raw beef manufacturing trimmings and the costs and benefits associated with the expansion of its non-O157 STEC testing to ground beef, bench trim, and other raw ground beef components.[1

Recent Changes to FSIS’ Laboratory Testing Criteria for Determining Positives

On April 16, 2021, FSIS announced in the Constituent Update changes to the laboratory testing criteria for E. coliO157:H7.[2FSIS explained that it had fully aligned the testing criteria for E. coli O157:H7 with that for non-O157 STEC. FSIS also explained that identifying specific bacterial genes associated with human illness is important for detecting STECs in food. Under the updated method, consistent with laboratory testing for non-O157 STEC, an E. coliO157:H7 isolate is confirmed positive if it has a stx gene, an eae gene, and is identified by the laboratory as O157. Further, under the new method, FSIS no longer performs H7 gene testing for certain O157:H7 isolates. Harmonizing STEC laboratory testing creates a more efficient FSIS laboratory workflow where all regulated STECs are treated the same from initial laboratory screening to full isolate characterization. This update did not affect current FSIS laboratory protocols leading to the reporting of potential and presumptive positive results. To implement this change, FSIS updated the Microbiology Laboratory Guidebook (MLG) Chapter 5C, “ Detection, Isolation, and Identification of Top Seven Shiga Toxin-Producing Escherichia coli (STECs) from Meat Products and Carcass and Environmental Sponges,”  [3and began using the updated STEC method on samples received on or after May 17, 2021.

Aligning the criteria for identifying positives for the top seven STECs of public health interest does not affect FSIS’ public health priorities, will not require establishments, or public health partners, or equivalent countries that ship beef to the United States to change their existing STEC laboratory methods that met the previous two separate STEC definitions, and may facilitate commercial test kit technology development.

Implementation

Currently, the only raw beef products FSIS routinely tests for non-O157 STEC are beef manufacturing trimmings. On February 1, 2023, FSIS plans to implement its expansion of its routine verification testing for the six non-O157 STEC that are adulterants to ground beef, bench trim, and other raw ground beef components for samples collected at official establishments. Once FSIS expands its non-O157 sampling to all raw beef products, for any positive results during routine verification testing, FSIS will conduct follow-up testing. FSIS will analyze all follow-up samples for all seven adulterant STEC and Salmonella.

Responses to Comments

In response to a request from multiple industry associations for more time to submit comments on the June 4, 2020 Federal Register notice, FSIS extended the comment period by an additional 30 days to September 3, 2020.[4FSIS received 10 comments. Specifically, FSIS received comments from a small establishment owner and an industry organization opposed to the expanded testing; while a food industry group, a consumer group coalition, and a college organization supported the expansion of testing. A foreign country and a laboratory testing representative also commented on the proposal. Two comments were outside the scope of this document.

In response to comments, FSIS added clarification on the new laboratory method, and a new table showing the additional cost of the expansion; but made no fundamental changes to the CBA. The Agency still plans to expand STEC testing to ground beef, bench trim, and other raw ground beef components. A summary of the issues raised by commenters and the Agency’s responses follows.

Cost and Benefits Analysis

Comment: An industry organization stated that the Agency did not adequately explain how it calculated an annual savings of $51.6 million from reduced non-O157 STEC outbreak-related recalls. Also, the commenter stated that the Agency did not provide data to support that the proposal will prevent two outbreak-related recalls per year because, according to the commenter, there were only a few non-O157 STEC outbreak-related recalls before 2012 and they are still rare.

The industry organization argued that FSIS’ contention in the CBA that detection can prevent recalls does not include supporting data. According to the commenter, the Agency started testing beef manufacturing trimmings for non-O157 STECs in 2012; therefore, FSIS should compare the number of non-O157 STEC outbreak related recalls before and after implementing this testing program to determine whether the theory has merit.

Response: In the 2020 CBA, FSIS explained how it determined that the proposed policy was likely to prevent, on average, two recalls per year at an estimated cost of $25.6 million per recall. It described the reasoning in detail in section 3.b “Benefits from reduced outbreak-related recalls” and section 4 “Net benefit” (pp. 19-23). FSIS clarified that the estimate was based on Public Health Information System (PHIS) data related to non-O157 STEC contamination and prevalence (i.e., Agency sampling data), not solely on the historical number of non-O157 STEC outbreak-related recalls.

Before 2012, FSIS did not routinely test raw beef products for non-O157 STEC, so it is not possible to make the proposed comparison between the number of recalls associated with beef products contaminated with non-O157 STEC versus recalls caused by E. coli O157:H7. The first non-O157 STEC investigation that led to a recall of ground beef product in the U.S. occurred in 2010. Once the Agency began testing for non-O157 STEC in raw beef manufacturing trimmings, the Agency prevented contaminated raw beef products from entering commerce. Beginning February 8, 2013, FSIS began to withhold its determination as to whether meat and poultry products are not adulterated, and thus eligible to enter commerce, until all test results that bear on the determination have been received (77 FR 73401). A substantial number of recalls (93 recalls) of raw beef products adulterated with STEC occurred between August 2012 and December 2020. Of these recalls approximately 20.0 percent (19 recalls) were caused by non-O157 STEC. Six of the 19 recalls were a result of outbreak investigations and seven were from routine FSIS verification testing. The remaining six recalls were results of: establishment-product testing (four), Agricultural Marketing Service (AMS) testing (one), and a notification from U.S. Food and Drug Administration (FDA) about contaminated flour used to produce a USDA regulated product (one).

As is stated above, currently, the only raw beef products FSIS routinely tests for non-O157 STEC are beef manufacturing trimmings. However, of the 19 non-O157 STEC recalls, 15 of them involved raw non-intact and ground beef products containing non-O157 STEC. Five of the 15 beef products recalled occurred as a result of FSIS routine and follow-up sampling of beef manufacturing trimmings and follow-up sampling verification programs. FSIS may have detected the other ten if FSIS had sampled the product through a routine verification sampling project. Analysis of the Agency’s historical testing data indicates that the number of beef manufacturing trimming samples positive for non-O157 STEC (0.71 percent) exceeded samples positive for E. coli O157:H7 (0.23 percent). Therefore, other beef samples subject to FSIS testing for E. coli O157:H7 may contain non-O157 STEC. As such, we believe it is reasonable to derive the estimate of prevented outbreak-related recalls from the detected prevalence of the pathogen.

Comment: An industry organization commented that the proposed expansion would not contribute to overall lower numbers of positive non-O157 test results. The commenter stated that there have been only two outbreaks of non-O157 STEC attributed to raw beef products since 2006 that resulted in recalls. In the same timeframe, the commenter stated that there have been eight E. coli O157:H7 outbreaks. In addition, the commenter stated that from 2006 to present, there have been 129 recalls for O157, compared to 20 for non-O157 STEC. Finally, the commenter stated that the vast majority of recalls for STEC are not associated with illnesses, because the presence of the pathogen is only part of the equation. Virulence, consumer health, handling, and preparation all play a part.

Response: The STEC pathogen must be present for an individual to show symptoms of the disease caused by that pathogen. FSIS has previously determined that raw, non-intact beef products or raw, intact beef products that are intended for use in raw, non-intact product, that are contaminated with STEC are adulterated within the meaning of 21 U.S.C. 601(m)(1) (76 FR 58157; Sep. 20, 2011). Virulence, consumer health, handling, and preparation may play a part in causing illness, but the key point is that the pathogen must be present.

Between August 2012 and December 2020 approximately 45 million pounds of contaminated raw beef products were prevented from entering commerce by FSIS because of STEC adulteration. Over this timeframe, FSIS tested a total of 167,073 raw beef samples for E. coli O157:H7 and 220 (0.13 percent) of these samples were positive. Analysis of the data tested for O157:H7 and non-O157 STEC by FSIS between August 2012 and December 2020 showed that non-O157 STEC were more frequently recovered from verification beef manufacturing trimming samples.

Specifically, FSIS tested 44,457 samples over the same timeframe as above. See table 1 below for the percent of positive samples for the different STEC.

SerogroupPercent of positive samples
Non-O157.71
O103.42
O157:H7.23
O26.15
O111.11
O145.022
O45.020
O121.016

FSIS raw beef verification testing has been effective in helping to protect the public by detecting E. coli O157:H7 and non-O157 STEC adulterants and preventing these products from entering commerce.

As mentioned, in response to a previous comment, between August 2012 and December 2020, there were 19 recalls of FSIS regulated products that were caused by adulteration of product by non-O157 STEC serogroups. These recalls show that non-O157 STEC can be present in products intended for commerce and represents a threat to public health.

According to the CDC, the number of culture-confirmed illnesses caused by non-O157 STEC have increased, and outpaced illnesses caused by O157:H7 STEC.[5Surveillance data presented by the CDC revealed that the percentage change in incidence of STEC infections in 2019 compared with the annual average incidence from 2016 to 2018 showed that O157:H7 decreased by 20 percent and non-O157 STEC increased by 35 percent.

Comment: An industry organization commented that the CBA relies on the outdated 2013 Pathogen Controls in Beef Operations Survey to evaluate the potential costs from expanded industry sampling in response to the proposal. According to the commenter, this survey may not accurately represent industry sampling practices, and, therefore, costs to industry may be underestimated due to outdated data. The commenter stated that the Agency should conduct an updated survey, with specific questions related to the proposal, and update the CBA before finalizing any changes to its STEC sampling program.

Response: FSIS does not require industry testing for STEC. Under the Hazard Analysis and Critical Control Point (HACCP) regulations, the establishment is required to identify the intended use of the product (9 CFR 417.2(a)(2)), conduct the hazard analysis (9 CFR 417.2(a)), determine the hazard(s) reasonably likely to occur (9 CFR 417.2(a)(1)), and support the decision(s)made (9 CFR 417.5(a)(1)). Also, all establishments are required to conduct on-going verification activities to ensure that their HACCP plans are effectively implemented (9 CFR 417.4(a)(2)). Establishments are required to conduct ongoing verification activities to ensure that any critical control point (CCP) is adequately addressing STEC, or that purchase specifications continue to prevent the pathogen from entering the facility. FSIS recommends that establishments’ verification activities include testing for STEC (67 FR 6232562331).

Lastly, the HACCP regulations in 9 CFR part 417 require that establishments validate the HACCP plan’s adequacy to control the food safety hazards identified by the hazard analysis (9 CFR 417.4(a)). These regulations prescribe requirements for the initial validation of an establishment’s HACCP plan and require that establishments “conduct activities designed to determine that the HACCP plan is functioning as intended.” Validation under 9 CFR 417.4(a)(1)requires that establishments assemble two types of data: (1) The scientific or technical support for the judgments made in designing the HACCP system, and (2) evidence derived from the HACCP plan in operation to demonstrate that the establishment is able to implement the critical operational parameters necessary to achieve the results documented in the scientific or technical support. Thus, validation of the HACCP system involves validation of the critical control points in the HACCP plan, as well as of any interventions or processes used to support decisions in the hazard analysis (80 FR 27557).

In 2012, FSIS explained in a Federal Register notice (77 FR 31979) how E. coli O157:H7 results can be used for non-O157 STEC HACCP decision-making. FSIS considers controls for E. coli O157:H7 to be effective against non-O157 STEC when implemented appropriately (85 FR 34397). How each establishment designs and supports their unique HACCP system can vary, and in-plant testing may or may not be conducted. When employed, testing can be conducted for different reasons, including to establish microbiological independence between lots, fulfill customer purchase specifications for specific products, validate HACCP controls, verify the HACCP system is functioning as intended, or other reasons. The frequency of sampling, products sampled, lot size, sampling method used, and laboratory testing methodology can vary from establishment to establishment based on the purpose sampling serves in each establishment’s HACCP system.

In 2013, FSIS conducted a survey of industry practices of STEC controls to evaluate the potential costs to industry of expanding sampling in response to the 2012 change. Since that survey in 2013, the above HACCP requirements have not changed, the Agency’s method of verification has not changed, and the Agency’s policy regarding the use of E. coliO157:H7 as an indicator for STEC has not changed. Though an establishment may conduct STEC testing for a variety of reasons as noted above, FSIS does not have reason to believe the data obtained in the 2013 survey is no longer reliable nor indicative (on the aggregate) of industry practices. Further, innovations in testing methodology have since occurred that can reduce the costs of STEC analysis (see Section of Recent Changes to FSIS’ Laboratory Method (85 FR 3439734399)). If FSIS assumes establishments do not adopt these cost-saving innovations, the results of the 2013 survey remain valid for cost estimations.

In response to the comments regarding the use of E. coli O157:H7 testing results for non-O157 STEC decision-making, under HACCP, establishments may be able to support using a single STEC serogroup ( e.g., E. coli O157:H7) as an “indicator” of all STEC as one component for demonstrating overall process control over STEC. If this approach is used, the decision-making for how E. coli O157:H7 results indicate control over non-O157 STEC is to be included in the hazard analysis and appropriately supported. Testing for E. coli O157:H7 as an indicator of STEC control may be acceptable for validation, verification, and process control because often the same controls address all STEC.

However, as explained in the Federal Register notice referenced above, both E. coli O157:H7 and non-O157 STECs occur in raw beef at low levels and at low prevalence, and positive tests for these pathogens are not likely to be highly correlated. For this reason, testing for a single STEC serogroup alone cannot serve as an “index” organism for any other STEC, meaning an E. coli O157:H7 result alone does not provide direct evidence about the actual presence or absence of any other STEC serogroups in a specific lot. If an establishment produces 2 lots of product from the same source material and if one lot is positive for a non-O157 STEC serogroup, then an E. coli O157:H7 negative test in the second lot of product would not be sufficient to show microbiological independence even with additional process control information. Such microbiological independence determination would include consideration of numerous other factors, including commonalities in the source materials used, sanitation practices employed, antimicrobial interventions applied, any process control information, other sample results, and illness reports. E. coli O157:H7 testing results alone are not sufficient evidence for microbiological independence following a non-O157 positive.

In addressing corrective actions after a positive STEC result, FSIS personnel are to consider the impact one or more non-O157 STEC positives may have on the adequacy of the HACCP system to control STEC but should not automatically expect establishments to begin non-O157 STEC testing. When a product tests positive for non-O157 STEC, it is important for the establishment to recognize that even though the E. coli O157:H7 results and other processing CCP records may indicate process control was maintained, identification of non-O157 STEC contamination in the production process questions whether design or implementation of the establishment’s unique food safety system is sufficient to control STEC. In response to one or more non-O157 STEC positives, establishments must ensure any additional testing conducted includes non-O157 as part of the validation, verification, and reassessment requirements of 9 CFR 417.4 and supporting documentation requirements of 9 CFR 417.5(a)(1), until the establishment is able to demonstrate control over STEC in their unique HACCP system, or the HACCP system may be deemed inadequate (9 CFR 417.6). For example, it is particularly important in veal establishments to demonstrate control over STEC because FSIS data and other peer-reviewed research shows a higher incidence of non-O157 STEC as compared to E. coli O157:H7.[6

Comment: An industry organization stated that after FSIS starts testing for non-O157 STEC in additional raw beef products, AMS will likely similarly expand its purchase program requirements as it has done in the past in response to FSIS sampling programs, which could increase industry costs.

Response: AMS has a Federal Purchase Program and vendors that choose to participate in that program must comply with AMS’s requirements, including any testing requirements. The requirements of AMS’s Federal Purchase Program are outside the scope of this Federal Register notice about FSIS’ non-O157 STEC testing program.

Response to Positive Test Result

Comment: An industry organization commented that the proposal should not affect practices that have proven successful in the industry’s continued improvement on STEC control. These practices have predominantly applied to beef manufacturing trimmings but should be accepted for any additional products that FSIS samples and tests when it implements expanded testing.

Response: If an establishment uses the same controls for STEC on beef manufacturing trimmings as it does on its other raw beef products, even if the other raw beef products were not slaughtered on-site, it should be able to support the decisions made in the use of such controls. How each establishment designs and supports their HACCP system may vary depending on the establishment and its hazard analysis, HACCP plan and the decisions made to support them.

Comment: A consumer group and a college organization commented that they did not support the use of E. coli O157:H7 testing results for non-O157 STEC decision-making and encouraged FSIS to amend its instructions to inspection personnel to require establishment non-O157 STEC testing to the same degree as E. coli O157:H7 testing. However, an industry organization’s comments did support using E. coli O157:H7 testing results for non-O157 STEC process control decision-making.

Additionally, an industry organization commented that the Agency and industry must appropriately understand and respond to positive STEC results, regardless of the serovar.

Response: FSIS does not require industry testing for STEC. Under the Hazard Analysis and Critical Control Point (HACCP) regulations, the establishment is required to identify the intended use (9 CFR 417.2(a)(2)), conduct the hazard analysis (9 CFR 417.2(a)), determine the hazard(s) reasonably likely to occur (9 CFR 417.2(a)(1)), and support the decision(s)-made (9 CFR 417.5(a)(1)). To be clear: this notice announces the expansion of non-O157 STEC testing by FSIS when it conducts routine verification testing. It does not impose testing requirements on industry.

As is stated above, FSIS considers controls for E. coli O157:H7 to be effective against non-O157 STEC when implemented appropriately (85 FR 34397). As mentioned above, in 2012, FSIS explained in a Federal Register notice (77 FR 31979) how E. coli O157:H7 results can be used for non-O157 STEC HACCP decision-making.

International

Comment: A foreign government questioned whether FSIS would provide a reasonable interval between the publication of the final Federal Register notice and when foreign countries would be required to implement new testing for non-O157 STEC.

Response: After FSIS expands its non-O157 STEC verification sampling and testing, FSIS will require foreign countries that ship beef product to the United States to implement equivalent government verification testing for non-O157 STEC in the same products included in FSIS’ new expanded verification testing program. FSIS acknowledges that foreign countries will need additional time to implement changes to their testing requirements and to provide applicable supporting documentation. FSIS will continue to use the existing equivalence process [7to ensure that foreign countries implement a government microbiological sampling and testing program equivalent to FSIS’ verification testing program for raw beef products within a reasonable time period. In addition, FSIS will begin testing imported ground beef, bench trim, and other raw ground beef components for non-O157 STEC at the same time as FSIS implements its domestic non-O157 STEC testing program ( i.e., on this notice’s effective date).

Test Only for Other Raw Ground Beef Components at Slaughter

Comment: Two industry organizations commented that FSIS should only expand testing to other raw ground beef components produced in slaughter establishments because STEC are introduced, and therefore most effectively controlled, at slaughter. Also, conducting the testing at slaughter establishments allows establishments to identify positive product before it enters commerce. The commenters argued that testing other raw ground beef components for non-O157 STEC at slaughter would prevent recalls and allow establishments to address the underlying cause at the source.

The commenters also stated that sampling and testing at further processing establishments makes it more difficult to identify the cause of the positive result and may increase the amount of product implicated in a recall. Also, according to the commenters, sampling ground beef does not provide feedback to either the processing establishments or slaughter establishments on process control. The commenters stated that the Agency should not include ground beef in the Agency’s expanded non-O157 STEC testing.

Also, one commenter disagreed with the Agency’s argument that by sampling bench trim, the Agency is verifying the product is not adulterated before it is ground. The commenter argued that instead of sampling for non-O157 STEC, FSIS should consider verification tasks at grinding establishments to ensure they maintain effective programs, such as purchase specifications or validated antimicrobial interventions.

Response: FSIS agrees that slaughter establishments are in the best position to prevent non-O157 STEC contamination because the introduction of the contaminant to the exterior surface of beef products can occur during the slaughter and dressing operation. However, processing establishments that receive product for grinding also have an important role in addressing non-O157 STEC. As explained above, the HACCP regulations require establishments to conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur in their processes and to identify the preventive measures they can apply to control those hazards in the production of particular products (see 9 CFR 417.2(a)). Consistent with the HACCP regulations, processing establishments can control or reduce non-O157 STEC to below detectable levels by using preventive measures, including validated antimicrobial interventions. Processing establishments can also establish as a preventive measure a purchase specification that requires suppliers to provide source materials with no detectable STEC. Processing establishments can then verify that these control measures are working as intended through their own product testing ( see67 FR 62325).

As stated earlier in the document, currently, the only raw beef products routinely tested for non-O157 STEC by the Agency are beef manufacturing trimmings, and beef manufacturing trimmings are produced at the slaughter establishment. However, of the 19 non-O157 STEC recalls, 15 of them were a result of raw non-intact and ground beef products containing non-O157 STEC. These 15 recalls support that expansion of routine non-O157 testing to other raw beef products, such as ground beef and other raw ground beef components, is necessary so that adulterated products do not reach the consumer.

Testing Based on Production Volume

Comment: An industry organization commented that FSIS should conduct sampling and testing for non-O157 STEC in applicable product in all establishments, regardless of production volume, for at least one year, and then FSIS should evaluate the data to determine whether continued sampling is warranted. This approach would allow additional components to be tested for non-O157 STECs at all establishment sizes for all products used as components for ground beef.

Response: Currently, per FSIS Directive 10,010.1, all establishments that produce raw beef products are subject to FSIS sampling and testing for STEC and Salmonella, regardless of establishment size. Consistent with the sampling frequency set in the directive, FSIS will sample each establishment that produces raw ground beef products at least three times per year. FSIS also samples establishments that produce bench trim, other raw ground beef components, or beef manufacturing trimmings at least once per year for each product. FSIS will continue to assess results and make necessary changes to its sampling and testing program. However, FSIS anticipates that it will continue this sampling and testing on an ongoing basis beyond one year of sampling and testing.

Testing Methods

Comment: One individual commented that STEC testing is much more sensitive than E. coli O157:H7 testing. The commenter stated that the STEC test is a presence or absence test that will show positive results with just a couple of cells. The commenter also stated that test results showing low numbers for Aerobic Plate Count (APC) and generic E. coliwould also test positive for STEC.

Response: As discussed earlier in the document, FSIS updated its laboratory method in 2019 to use a single, combined workflow to screen samples for the presence of E. coli O157:H7 and the six non-O157 STEC that FSIS considers adulterants (O26, O45, O103, O111, O121, or O145). The technology used for screening samples allows all seven STEC serogroups to be screened identically. FSIS utilizes the following performance criteria and definitions when evaluating the suitability of an alternative laboratory method for a given analyte and sampling matrix pair: [8

  • Sensitivity of 90 percent or greater,
  • Specificity of 90 percent or greater,
  • Accuracy of 90 percent or greater,
  • Positive Predictive Value of 90 percent or greater, and

• Negative Predictive Value of 90 percent or greater. FSIS’ internal verification work during the selection of new technologies in 2018 found a sensitivity of 92 percent in STEC samples inoculated with approximately 1 CFU in a 325g sample for that technology.[9The manufacturer determined the average limit of detection (LOD50 ) of the iQ-Check STEC VIrX and SerO II method was 0.7 (range: 0.4-1.2) CFU/sample for O157 and other adulterant STEC.[10There is no difference in sensitivity for E. coli O157 and other non-O157 adulterant STEC serogroups. Additional information for using this method may be found in Chapter 5C of the MLG and associated appendices.[11

Testing Results

Comment: An industry organization commented that follow-up sampling conducted by the Agency in response to an E. coli O157:H7 positive in products only subject to E. coli O157:H7 testing should continue to be tested for all STEC, but the results should not be included in baseline and routine verification data (prevalence). According to the commenter, the Agency also incorrectly included follow-up sampling as part of the aggregated prevalence data in the proposed expansion of products tested for STEC. The commenter noted that FSIS previously reported follow-up sampling independently from routine sampling data and, according to the commenter, should consistently do so moving forward. According to the commenter, follow-up samples should never be included in overall prevalence calculations of O157 or non-O157 STEC. According to the commenter, follow-up sampling is conducted in response to a positive sampling result, which may indicate issues with process control at that establishment and can therefore skew the data.

Response: FSIS collects follow-up samples as a result of a positive from a routine verification sample. The purpose of scheduling these follow-up samples is to determine whether the establishment effectively addresses STEC. As mentioned above, once FSIS expands its non-O157 sampling to all raw beef products, FSIS will analyze all follow-up samples for all 7 adulterant STEC and Salmonella. FSIS posts the follow-up sampling results separately on its website.

When calculating prevalence, FSIS does not use follow-up sampling in its prevalence calculations. Also, FSIS does not typically use follow-up samples in its baseline studies.

Reallocating Resources

Comment: Two organizations commented that the Agency should explain its reasoning for changing its allocation of resources for sampling STECs. According to the commenters, the Agency intends to sample once per week in higher volume establishments, a slight increase from four samples per month, by reallocating resources from lower-volume establishments. The commenters argued that the slight increase will likely not cause significant issues in high volume establishments, but there is not enough information about the reallocation to understand the potential impact of decreased sampling at lower volume establishments. The commenters argued that the shift in sampling may represent a significant reduction or elimination of sampling in lower volume establishments. According to the commenters, the data should be analyzed by volume to determine whether a decrease in sampling frequency at lower volume establishments will inhibit the Agency from identifying establishments that may have issues with STEC control.

A college organization noted that diverting current testing resources from lower-volume establishments will result in extending the time required for determining establishment performance, potentially increasing the risk of contaminated products entering the marketplace. According to the commenter, until FSIS has demonstrated that reallocating samples among beef processors will not negatively impact public health, the Agency should focus on requesting additional resources from Congress for sampling and laboratory testing. The commenter encouraged FSIS to consider how microbial distribution within a product and/or false-positive test results may affect Agency verification results.

Response: FSIS may address allocating resources for sampling in a future Federal Register document, but FSIS believes the Agency has sufficient resources to conduct sampling and testing for STEC, ensuring that the nation’s commercial supply of raw beef products, whether domestic or imported, is safe, wholesome and unadulterated.

After implementation, the Agency may adjust the numbers of samples collected and tested +/− by approximately 10 percent. FSIS has a set minimum sampling frequency for each establishment. FSIS will sample each establishment that produces raw ground beef products at least three times per year. FSIS also samples establishments that produce bench trim, other raw ground beef components, or beef manufacturing trimmings at least once per year for each product.

Sampling Methodology

Comment: An industry organization noted that FSIS is evaluating alternatives to its sampling procedures ( e.g., assessing sampling using a surface swabbing with a cloth vs. N60 incision sampling). According to the commenter, methodology often has a significant impact on baseline results, which are used to inform the public health decisions of local, state, and federal bodies and other private entities, and support Agency decisions. The commenter argued that the Agency should conduct a short-term, targeted baseline sampling program after a change in methodology and make the new information public with explanations. According to the commenter, this approach will help provide context to preclude public uncertainty if prevalence seemingly increases because the new methodology increases sensitivity and detectability.

Additionally, the same commenter argued that potential changes to sampling methodology for pathogen sampling should be available for public comment. According to the commenter, the industry and other interested parties need time to consider impacts of the new methodology and provide information to the Agency to inform its decision-making. Also, an industry association and an individual commented that FSIS should continue to explore rapid and accurate methods to test for all pathogens of concern. One commenter encouraged FSIS to continue to work with industry and academia to develop rapid tests using the latest technology available to identify STEC and other pathogens in FSIS regulated products.

Response: FSIS continues to update its laboratory criteria and posts changes to its laboratory method in the MLG Chapter 5C titled “ Detection, Isolation, and Identification of Top Seven Shiga Toxin-Producing Escherichia coli (STECs) from Meat Products and Carcass and Environmental.” FSIS also usually announces these changes in the Constituent Update.

FSIS recognizes the importance of keeping abreast of the latest scientific endeavors as well as its role in promoting research in areas important to the FSIS mission. FSIS food safety research priorities [12are presented as suggestions for researchers interested in pursuing food safety objectives that are relevant to FSIS regulated products. This list of research areas of interest may be useful to researchers who are preparing grants for submission to agencies that fund food safety research ( e.g., USDA National Institute of Food and Agriculture ( https://www.nifa.usda.gov), National Institutes of Health ( https://www.nih.gov/​), Grants.gov ( https://www.grants.gov), or researchers with resources to conduct such research. In 2021 FSIS added a study titled, “Develop a method to detect Shiga toxin-producing Escherichia coli (STEC) based on virulence factors,” to the Food Safety Research Priority list.

As mentioned in its June 4, 2020 Federal Register notice (85 FR 34397), FSIS is conducting an in-field surface sampling study to determine the feasibility of a non-destructive surface sample collection method to collect raw beef manufacturing trimmings verification samples. FSIS will announce any changes to the sample collection method for the beef manufacturing trimmings project in a future Federal Register notice.

Data for Agency Policy

Comment: An industry organization commented that FSIS should use relevant scientific data for Agency policy. Specifically, the aggregated data by calendar year publicly available on FSIS’ website incorrectly includes sample results from multiple slaughter classes of cattle, different sampling categories, and is not appropriately stratified. In the aggregated data, the commenter stated that the Agency does not separate samples attributed to different slaughter classes of cattle, such as veal. The commenter stated that different slaughter classes of cattle have varying risks of O157 and non-O157 STEC contamination, and FSIS should evaluate the risk of these different slaughter classes separately.

Response: In the discussion regarding aggregated data, FSIS stated the sampling results from FSIS verification testing programs includes data from veal establishments and follow-up sampling results.[13Using aggregated sampling results is appropriate because FSIS is not proposing any changes to sampling allocations by slaughter class as part of the lab testing change. Therefore, the portion of samples collected from each slaughter class and the overall aggregate sampling is expected to remain consistent. The information showed that FSIS was finding non-O157 positive results in its verification sampling programs across all slaughter classes.

USDA’s Non-Discrimination Statement

In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, USDA, its Mission Areas, agencies, staff offices, employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Program information may be made available in languages other than English. Persons with disabilities who require alternative means of communication to obtain program information ( e.g., Braille, large print, audiotape, American Sign Language) should contact the responsible Mission Area, agency, or staff office; the USDA TARGET Center at (202) 720-2600 (voice and TTY); or the Federal Relay Service at (800) 877-8339.

To file a program discrimination complaint, a complainant should complete a Form AD-3027, USDA Program Discrimination Complaint Form, which can be obtained online at https://www.ocio.usda.gov/​document/​ad-3027, from any USDA office, by calling (866) 632-9992, or by writing a letter addressed to USDA. The letter must contain the complainant’s name, address, telephone number, and a written description of the alleged discriminatory action in sufficient detail to inform the Assistant Secretary for Civil Rights (ASCR) about the nature and date of an alleged civil rights violation. The completed AD-3027 form or letter must be submitted to USDA by:

(1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; or

(2) Fax: (833) 256-1665 or (202) 690-7442; or

(3) Email: program.intake@usda.gov.

USDA is an equal opportunity provider, employer, and lender.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: https://www.fsis.usda.gov/​federal-register.

FSIS will also announce and provide a link to it through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Updateis available on the FSIS web page. Through the web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: https://www.fsis.usda.gov/​subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

Done at Washington, DC.

Paul Kiecker,

Administrator.

Footnotes

1.  The CBA is available at: https://www.fsis.usda.gov/​sites/​default/​files/​media_​file/​2020-07/​FSIS-Non-0157-STEC-Testing-CBA-June-2020.pdf.Back to Citation

2.   https://www.fsis.usda.gov/​news-events/​news-press-releases/​constituent-update-april-16-2021.Back to Citation

3.   https://www.fsis.usda.gov/​sites/​default/​files/​media_​file/​2021-04/​MLG-5C.01.pdf.Back to Citation

4.   https://www.fsis.usda.gov/​news-events/​news-press-releases/​constituent-update-june-19-2020.Back to Citation

5.  Ibid.Back to Citation

6.   https://ask.usda.gov/​s/​article/​When-an-establishment-only-conducts-product-testing-for-E-coli-what-factors-does-the-establi.Back to Citation

7.   https://www.fsis.usda.gov/​inspection/​import-export/​equivalence.Back to Citation

8.  MLG 1.01- https://www.fsis.usda.gov/​sites/​default/​files/​media_​file/​2021-03/​MLG-1.01_​0.pdf.Back to Citation

9.   https://www.fsis.usda.gov/​sites/​default/​files/​media_​file/​2021-09/​Molecular-Screen-Evaluation-2018-White-Paper.pdf.Back to Citation

10.   https://www.bio-rad.com/​sites/​default/​files/​2021-08/​Bulletin_​3213.pdf.Back to Citation

11.   https://www.fsis.usda.gov/​sites/​default/​files/​media_​file/​2021-04/​MLG-5C.01.pdf.Back to Citation

12.   https://www.fsis.usda.gov/​science-data/​research-priorities.Back to Citation

13.   https://www.fsis.usda.gov/​science-data/​data-sets-visualizations/​microbiology/​microbiological-testing-program-escherichia-coli.Back to Citation

[FR Doc. 2022-25140 Filed 11-17-22; 8:45 am]

Statement of Jerold Mande, CEO, Nourish Science

FDA Proposed Redesign of Human Foods Program

I congratulate Dr. Califf and FDA for making a serious effort to address FDA’s many food failings. Unfortunately, they failed to use this hard work to produce a plan that solves the fundamental problems.

The #1 problem is inadequate resources including budget. This plan doesn’t propose them.

#2 we must make at least an equal effort to combat acute and chronic food illness. This plan will take nutrition, which is currently listed equally with food safety, and relegate it to what seems to be a small, unfunded, and separate center.

FDA was created to ensure processed food doesn’t make us sick, acutely or chronically. This plan will do virtually nothing to reduce the 1,600 deaths a day due to chronic food illness.

It’s time to move the F in FDA to a “Department of Food and Agriculture” that would elevate food & nutrition policy to the Cabinet level where it needs to be.

It is past time for Congress and the Administration to step in and solve the FDA organizational problems that seems to elude the FDA bureaucracy.

Safe food should not be a political issue.

Perhaps, because after 30 years in the food poison trenches, I had a good idea what was going to happen (or not), or perhaps I too got the embargoed FDA Statement on “FDA Proposes Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities.”

Embargoed FDA statements, like confidential Presidential documents, seem to be everyplace all at once.

Sources aside, Drs. Califf’s and Woodcock’s “plan” announced this morning is nothing more than a well-crafted (embargoed to increase the feeling of exclusivity) press release that rearranges the deck chairs on the USS FDA – food safety iceberg be damned.

The FDA essentially ignored the people selected by the Reagan-Udall Foundation to give the FDA suggestions on how to fix both the structure of the food side of the FDA and to move towards a more proactive culture of food safety writ large. Here is the present FDA Organization Chart (highlights by me of the Centers that need to be unified under either an empowered Deputy Commissioner for Foods or a separate Commissioner of Foods who reports to the HHS Secretary).

Xavier, Hakeem, Kevin, Mitch, Chuck and Joe, do you know that 48,000,000 of us get poisoned yearly by the “safest food supply in the world”?  And, that is just bacteria and viruses.  If you consider the food with too much salt, sugar and fat, that the FDA also does an inadequate job of regulating, millions of all of us become ill and die needlessly from this “safe food.”

Xavier, Hakeem, Kevin, Mitch, Chuck and Joe, before yet another food crisis like infant formula or E. coli-tainted romaine happens again – DO SOMETHING!

Xavier, Hakeem, Kevin, Mitch, Chuck and Joe, read the Reagan-Udall report. Hold hearings. Ask hard questions. Seek input from consumers and food processors on how best to organize the FDA to meet its Mission Statement: “The Food and Drug Administration is responsible for protecting the public health … by ensuring the safety of our nation’s food supply, … .”

This can be done. Government can work. Please step up and be the leaders that we need.

Tomorrow is the long-anticipated day that Dr. Califf is set to announce his intentions on how or if to implement the recommendations of the Reagan-Udall Foundation panel’s review of the FDA’s human foods program.

On behalf of the 48,000,000 Americans sickened by a foodborne illness yearly in the U.S. and the millions who die of diseases brought on by too much salt, sugar and fat, I hope is that it is more that “rearranging the deck chairs on the USS FDA.

I have said too often that my vision of a more empowered food-side (food poisoning and nutrition) of the FDA would have been to create two Senate appointed commissioners – one with a portfolio of all aspects of food and one with a portfolio of drugs and medical devices. 

Here are many who I admire that have hope as well.

American Frozen Food Institute, Association of Food and Drug Officials, Consumer Brands Association, Consumer Reports, Environmental Working Group, International Fresh Produce Association, STOP Foodborne Illness, Western GrowersDiverse coalition calls on FDA to outline meaningful reforms in announcement on foods program

WASHINGTON, D.C. – A diverse coalition of food policy stakeholders representing consumers, industry, and state and local regulators reiterated its call for significant structural reform of FDA’s foods program ahead of the agency’s anticipated January 31 announcement on how it intends to implement recommendations from a report by the Reagan-Udall Foundation.

The coalition commended the report when it was released in December of last year, noting that the expert panel accurately captured problems related to the structure, leadership, culture, transparency, and accountability within FDA’s foods program. Importantly, the report reinforces the coalition’s call for an expert, empowered deputy commissioner for food who could unify the program and elevate its stature within FDA.

The coalition reiterated the need for bold reforms that incorporate the following elements:

Full Unification of the Human and Animal Foods Program under an Expert Leader

Establishing an empowered deputy commissioner position with direct line authority over all components of FDA’s human and animal foods program is foundational to its operational success and essential culture change. In practice, this means unifying into a cohesive organizational structure — headed by the deputy commissioner — the Center for Food Safety and Applied Nutrition (CFSAN), the food and feed-related activities of the Center for Veterinary Medicine (CVM), and all the food-related components of the Office of Regulatory Affairs (ORA), including inspection and compliance, food-related laboratories, import oversight, state partnerships, training, and information technology.

Candidates for the empowered deputy commissioner role should possess the attributes recommended in the report, including expertise and knowledge in food safety and/or nutrition; demonstrated strong leadership, management, and communications skills; and the ability to lead and make timely decisions in a complex regulatory environment.

An Elevated, More Prominent Foods Program

The empowered deputy commissioner should be viewed internally and externally as the commissioner’s surrogate for all FDA food activities and as the agency’s leader, spokesperson and decision-maker for the foods program. The position should have the authority and standing within FDA and HHS, to represent FDA on foods program issues and funding before Congress, within the executive branch, as well as with stakeholders and foreign partners.

Culture Change and Modernization

Reframing the culture within the foods program is a prerequisite to the success of its structural reform. The current fragmented structure and lack of central authority and leadership contributes to a culture of silos, indecision, inaction, and delay in implementing the prevention mindset called for in the Food Safety Modernization Act (FSMA). The deputy commissioner should also be mandated to modernize the program in a way that facilitates transparency, timeliness, and meaningful stakeholder engagement as part of its decision-making process.

The FDA’s foods program is a distinctive part of the agency and deserves a structure and leadership model that is appropriately customized to fit its mission. We look forward to FDA Commissioner Califf’s pending announcement and remain committed to working with the agency as changes are implemented.

And, one would think the head of the FDA, would pay attention to those with the purse strings.

DURBIN, DELAURO URGE FDA COMMISSIONER CALIFF TO IMPLEMENT REFORMS AT THE AGENCY’S HUMAN FOODS PROGRAM

The letter follows the Reagan-Udall Foundation’s report which outlined significant flaws within FDA’s Human Food Program

WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Representative Rosa DeLauro (D-CT) sent a letter to the Food and Drug Administration (FDA) Commissioner Dr. Robert Califf urging him to make critical reforms within FDA’s Human Foods Program.  This follows the Reagan-Udall Foundation’s recent external evaluation and report, which outlined various flaws at FDA including their slow response to foodborne illness outbreaks, particularly with infant formula, and lack of implementing the Food Safety Modernization Act (FSMA), which Durbin and DeLauro authored.  In response to the report, Commissioner Califf plans to release a public update on his new vision of FDA soon. 

“We are writing regarding the Reagan-Udall Foundation’s critical review of the Food and Drug Administration’s (FDA) Human Foods Program,” wrote Durbin and DeLauro.  “You previously stated that this review would help inform a ‘new vision’ for FDA that will be announced at the end of this month.  As part of this ‘new vision,’ we encourage you to embrace the significant leadership and structural reforms that the Foundation recommended in its report.  American families cannot afford for FDA to continue its inadequate food oversight, especially when we now have a comprehensive analysis of how to start to remedy the agency’s food safety failures.”

FDA is responsible for the oversight of nearly 80 percent of food in the United States.  Too often, however, FDA has failed to protect Americans from dangerous food pathogens and outbreaks.  Every year, more than 48 million Americans are sickened, 128,000 are hospitalized, and 3,000 lose their lives because of some bacteria or virus in their food.  In 2011, FMSA was signed into law to transform the United States’ approach to foodborne illnesses.  FSMA requested FDA to be more proactive, not reactive, to foodborne illnesses to prevent outbreaks in the first place.  FSMA empowered FDA with new authorities, resources, and funding to accomplish this goal.  But, as outlined in the Reagan-Udall report, FDA has not made this shift, despite FSMA’s passage more than a decade ago.  FSMA required FDA to promulgate several rules so that it would prevent rather than respondto foodborne outbreaks.  However, more than a handful of times, FDA missed congressionally mandated deadlines to implement them.  FSMA also required FDA to “increase the frequency of inspection of all [food] facilities,” to ensure companies’ compliance with safety and quality standards.  But, FDA inspections have plummeted since FSMA was signed into law.

The letter cites FDA’s failures to respond to a compliance issue at Abbott Nutrition’s Sturgis, Michigan, facility which manufactures infant formula.

“However, despite the vulnerable population that consumes the products manufactured at this facility, FDA did not follow up and inspect the facility until January 2022, upon which it found several samples to suggest the presence of Cronobacter.  Even then, FDA did not request that Abbott initiate a recall of their infant formula—nor warn consumers—until mid-February 2022.  It’s difficult to explain why FDA moved this slowly, even when this issue hospitalized at least four infants, claimed two of their lives, and had the potential to harm the health and well-being of other infants across the nation,” the letter continued.

In July, Durbin, DeLauro, and Senator Richard Blumenthal (D-CT) introduced the Food Safety Administration Act of 2022, legislation that would establish the Food Safety Administration, a single food safety agency responsible for ensuring the safety of our nation’s food supply.  This new agency would take over food safety responsibilities currently housed at FDA.  In the Reagan-Udall Foundation’s report, this proposal was included as their first option for structural reform at FDA.

The letter also urged Commissioner Califf to empower a Deputy Commissioner for Foods with authority over the Human Foods Program; separate the Center for Food Safety and Applied Nutrition (CFSAN) into a “Center for Food Safety” and a “Center for Nutrition;” and directly integrate the Office of Regulatory Affairs’ (ORA) food-related inspectional and compliance responsibilities within the Human Foods Program.

The letter concluded, “As commissioner, you have the power to turn the FDA into an organization that meets its mission and prevents foodborne illnesses and outbreaks—saving and improving lives nationwide.  Now is the time for real reform at FDA—it is not the time for half measures or more excuses.  We look forward to learning more about your ‘new vision’ for FDA’s Human Foods Program later this month.”

Full text of today’s letter is available here and below:

January 30, 2023

Dear Commissioner Califf:

            We are writing regarding the Reagan-Udall Foundation’s critical review of the Food and Drug Administration’s (FDA) Human Foods Program.  You previously stated that this review would help inform a “new vision” for FDA that will be announced at the end of this month.  As part of this “new vision,” we encourage you to embrace the significant leadership and structural reforms that the Foundation recommended in its report.  American families cannot afford for FDA to continue its inadequate food oversight, especially when we now have a comprehensive analysis of how to start to remedy the agency’s food safety failures.

            In addition to its other duties, FDA is responsible for the oversight of nearly 80 percent of food in the United States—from peanut butter, to lettuce, to infant formula.  Too often, however, the FDA has failed to protect Americans from dangerous food pathogens and outbreaks.  Every year, more than 48 million Americans are sickened, 128,000 are hospitalized, and 3,000 lose their lives because E. Coli, Norovirus, Salmonella, or some other bacteria or virus in their food.  This pain, suffering, and loss of life is unacceptable; and, even more infuriating, it can be prevented. 

            In 2011, the FDA Food Safety Modernization Act (FSMA), legislation we crafted to transform our nation’s approach to foodborne illnesses, was signed into law.  It had a simple premise:  FDA was too reactive to foodborne illness outbreaks, acting only after a problem had arisen and people had been sickened.  We worked with bipartisan Members of Congress, consumer organizations, and food companies to turn FDA into an organization that would prevent outbreaks in the first place.  The FSMA empowered the FDA with new authorities, resources, and funding to accomplish this goal.  But, as outlined in the Reagan-Udall report, FDA has not lived up to its end of the bargain, despite the FSMA’s passage more than a decade ago. 

            For example, in October 2021, FDA was alerted to significant compliance issues at Abbott Nutrition’s Sturgis, Michigan, facility—a facility responsible for manufacturing infant formula.  However, despite the vulnerable population that consumes the products manufactured at this facility, FDA did not follow up and inspect the facility until January 2022, upon which it found several samples to suggest the presence of Cronobacter.  Even then, FDA did not request that Abbott initiate a recall of their infant formula—nor warn consumers—until mid-February 2022.  It’s difficult to explain why FDA moved this slowly, even when this issue hospitalized at least four infants, claimed two of their lives, and had the potential to harm the health and well-being of other infants across the nation.

            Americans deserve better than what FDA has done to ensure food safety.  That is why we introduced a bill last Congress to create a new, independent “Food Safety Administration” responsible for taking over FDA’s food oversight responsibilities.  In the Reagan-Udall Foundation’s report, this proposal was included as their first option for structural reform at FDA.  We understand that this change would require congressional action and would be difficult to accomplish in a divided Congress.  However, FDA should take this recommendation to heart and begin undertaking meaningful steps to improve the Human Foods Program in the meantime.

As was outlined in the report, the Human Foods Program must be unified under a single leader and restructured.  To this end, we urge you to empower a Deputy Commissioner for Foods with authority over the Human Foods Program; separate the Center for Food Safety and Applied Nutrition (CFSAN) into a “Center for Food Safety” and a “Center for Nutrition;” and directly integrate the Office of Regulatory Affairs’ (ORA) food-related inspectional and compliance responsibilities within the Human Foods Program.

As commissioner, you have the power to turn the FDA into an organization that meets its mission and prevents foodborne illnesses and outbreaks—saving and improving lives nationwide.  Now is the time for real reform at FDA—it is not the time for half measures or more excuses.  We look forward to learning more about your “new vision” for FDA’s Human Foods Program later this month.

Well, we shall see. Check back tomorrow to see of the USS FDA successfully avoided the iceberg.

Dr.  Califf, I have deep admiration for your past and ongoing public service.  The hard work of trying to protect the food and drug supply in the United States is a difficult and at times thankless task.  The fact that you have taken this responsibility on more than once speaks volumes to your character.

Your decision post the infant formula scare and shortage in asking the Regan-Udall Foundation to take a critical look at the culture and structure of the FDA took a bit of confidence and a lot of courage.  I had the honor to testify before your chosen panel and stayed to listen to the full two days of testimony from thought leaders – consumer, industry, academia and government – on how the “F” in FDA could best accomplish its mission.

Pulling from the panel’s recommendations, the FDA’s path to a safer food supply seems clear albeit a lot to “chew on”:

Most FDA employees understand the immense responsibility of the Agency’s Human Foods Program, appreciate the importance of their work, and share a common value of striving to protect public health. However, the current culture, structure, and governance model detract from the Program’s effectiveness. 

There are several factors contributing to this culture, including the lack of a clear vision and mission; a disparate structure and a consensus governance model; competing priorities; and the lack of a strong, supportive leader and, when the situation requires, an ultimate decision-maker, who is responsible for the Human Foods Program. The lack of a clear overarching leader of the Human Foods Program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration. 

The lack of a single clearly identified person to lead the Human Foods Program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil…. As senior leaders are considered for the Human Foods Program, an ideal leadership skill set should include: 

  • Expertise and knowledge in food safety and/or nutrition 
  • Ability to make decisions in a complex regulatory environment 
  • Ability to lead in a complex work environment 
  • Strong demonstrated management capability 
  • Superb communication skills 
  • Ability to identify and nurture talent 
  • Commitment to collaboration, not isolation 
  • Capable of breaking down silos 
  • Proven abilities to lead, support, and incent teamwork 
  • Ability to support initiatives that increase staff professionalism and performance 
  • Commitment to joint staff development and other activities by the collective parts of the Human Foods Program 

To move the Human Foods Program toward a more enabling and effective culture, the Panel recommends FDA leadership consider the following:

  • Identify, communicate, embrace, and promote a clear and compelling vision, mission, and value statement for the Human Foods Program.
  • Establish an organizational structure with a clear leader and ensure that there is a clear articulation of roles and responsibilities within the Human Foods Program and a culture that is well-equipped to survive (inevitable) leadership transitions.
  • Develop and nurture a culture where regulatory decision-making is rooted in scientific evidence and FDA’s legal framework. 
  • Commit to transparency, timeliness, and predictability in decision-making, with a preference towards action. 
  • Commit to an on-going process of culture change from the highest levels of FDA leadership. 
  • Develop and implement a change management strategy that not only manages change, but also effectively improves and monitors the environment for cultural change. 
  • Build expectations and incentives into the system to embrace a positive, collaborative culture that expects, values, and rewards teamwork. 
  • Create a culture of feedback and authenticity where continuous, honest, and constructive feedback is given and received.
  • Nurture current staff and recruit, hire, and promote top quality staff, including strong managers. 

FDA should increase the visibility and prominence of the Human Foods Program. 

Given the economic impact that foodborne illness and diet-related chronic disease have on Americans and the federal budget, it is imperative that the Human Foods Program become more prominent. When compared to the medical products programs within FDA, the Human Foods Program continuously struggles for visibility and prominence. A component of this elevation of the Human Foods Program is strong advocacy to advance the Human Foods Program at all levels of the government, especially at the Department of Health and Human Services (HHS) and the White House, including the Office of Management and Budget. 

  • The Human Foods Program should have clear lines of authority. 
  • Within the Human Foods Program, the importance of nutrition should be elevated. 
  • The foods portfolio of ORA should be integrated directly with the other elements of FDA’s Human Foods Program.
  • The food-relevant work of CVM should be integrated with the overall FDA Human Foods Program. 
  • A new Foods Advisory Committee, at the Commissioner-level, should be established to strengthen external input to Human Foods Program activities.

My vision of a more empowered food-side of the FDA would have created two Senate appointed commissioners – one with a portfolio of all aspects of food as mentioned above and one with a portfolio of drugs and medical devices.  However, I learned long ago to listen to those who swim in the deeper end of the intelligence pool.  I think you agree with that.  As you were recently quoted in an interview with the Washington Post:

In 2016, there was a deputy commissioner who was empowered. First, I was very comfortable with it. Secondly, it didn’t fix all the problems. There are still issues within that that need to be dealt with. We are coalescing on a plan. I had a deputy commissioner [when I was FDA Commissioner in 2016]. Scott Gottlieb [the next FDA Commissioner] changed that. If a commissioner comes in with grandiose ideas and gets halfway through a change, that’s not good for people. I think we are going to put in structures that are going to survive.

It seems that you, the Regan-Udall Foundation and the recently departed Frank Yiannas agree on the need for a revised structure within the FDA and the need for a person empowered to deliver and be accountable for creating “the safest food supply in the world”. As Mr. Yiannas recently said:

One, based on my experience these past four years, I (as well as a diverse group of Bipartisan Congressional Leaders and Consumer, State Regulatory, & Industry Stakeholder Groups) firmly believe the agency would operate more effectively and be better able to protect the American public from foodborne illness, with the creation of a more integrated operating structure and a fully empowered and experienced Deputy Commissioner for Foods, with direct oversight of those centers and offices responsible for human and animal foods. In this manner, she or he can more easily make the necessary changes that are needed to transform FDA’s Food Program for the 21st Century. Secondly, I also urge you to consider transferring the small, yet exceptional staff comprising the Office of Food Policy and Response (OFPR) to a new office of the Deputy Commissioner for Foods.

Dr. Califf, thank you for your leadership.  The 48,000,000 who are sickened yearly by food they consume, the 125,000 hospitalized and the 3,000 that die are counting on you.

Dr. Califf, one final thought; lock the door and do not let Frank Yiannas leave the building.  

Although I do not always agree with Mr. Yiannas on policy, the Regan-Udall Foundation’s definition of “ideal leadership” reads like a Frank Yiannas resume.  The FDA needs someone with broad private sector experience who understands that the power of the FDA to effectuate positive food safety changes – including human nutrition – will come from both consumer and industry stakeholders – not exclusively within the present FDA structure.

When you make the FDA structural change, you need to have someone (Frank Yiannas) at your side.  Do not let this moment pass.  We all depend on you.

This just hit my inbox. I’ll have more to say.

January 25, 2023

Dr. Califf:

This letter is to inform you that I am resigning my position as FDA Deputy Commissioner for FoodPolicy and Response effective February 24.

In December of 2018, I joined the FDA with the goal of helping to modernize the food safety oversight system in the United States and protecting the American people from contaminated food.I wanted to build on my work of protecting consumers by elevating food safety standards and building more effective, modern, and innovative food safety approaches, something I did in the private sector for more than 30 years.

Despite the unprecedented challenges we’ve faced in the past four years (such as a globalpandemic, unparalleled food supply chain disruptions, and six different acting or permanentcommissioners), thanks to the dedicated staff working on food safety throughout the FDA, I believewe made real improvements towards this goal.

Advancing FSMA

First, almost a decade since its passage and after the agency experienced three separate lawsuits(before my arrival) for failing to achieve several Food Safety Modernization Act (FSMA) mandates,we made needed and strategic progress by tackling two of the most critical, complicated, andoutstanding FSMA rulemakings by issuing a Final Food Traceability Rule and a new, proposedAgricultural Water Standard. While the FSMA-projected reductions in foodborne illnesses have yetto be realized a decade later, these two rules, once fully implemented, will be gamechangers inallowing those reductions to become a reality.

A New Era of Smarter Food Safety

But we didn’t stop there. Modern times require more modern approaches. Therefore, shortly aftermy arrival, we assembled some of the brightest minds in food safety from within and outside theFDA to help us prepare for the future. Based on their input, in 2020 and under the auspices of a NewEra of Smarter Food Safety, we unveiled a new vision and blueprint for the next decade tomodernize the way FDA does its food safety work and to bend the curve of foodborne illness onceand for all in this country. And in two short years, we achieved an amazing amount of work. Forexample, we leveraged smarter tools for prevention used for the very first time in FDA’s foodprogram, such as employing Artificial Intelligence to strengthen our ability to detect and preventviolative shipments of imported seafood from reaching the U.S. consumer. We also expedited andfacilitated the use of Tech-enabled Food Traceability to create a more transparent food system.And at a time of heightened food supply chain disruptions, we unleashed the power of data with the development of 21 Forward, a first of its kind food supply chain analytical platform to identify food facilities at greatest risk of food supply chain disruptions. We also launched a pilot to evaluate if select third party food safety standards aligned with FSMA and determine what role they might play in the nation’s food safety oversight system. And we advanced the concept of Food Safety Culture to achieve higher rates of compliance and to mobilize industry to do the same, realizing that advancing food safety requires going beyond traditional approaches, through a betterunderstanding of human behavior and organizational dynamics.

A Record of Prevention

Importantly, while regulatory activities matter, they’re not what matters most. What matters mostis outcomes or proven results that our work is achieving reductions in foodborne illnesses. Andearly indications are that we’ve been successful here too, whether it’s been through our work torally stakeholders to break the cycle of recurring outbreaks around Thanksgiving linked to fresh leafy greens through FDA’s Leafy Green Action Plan or, after 8 years and 8 outbreaks, breaking the cycle of Salmonellosis during the summer linked to imported papayas, through an enhanced Food Safety Partnership between the U.S. and Mexico, as just a couple of examples.

Tackling Foodborne Outbreaks Faster

And while prevention has been and must always be our focus, tackling foodborne outbreaks fasterand revealing their root cause is also essential to preventing future outbreaks, so here too, we made significant progress. For example, we strengthened FDA’s foodborne outbreak investigations and almost doubled the number of outbreak investigation reports the agency now publishes. Also, as a commitment to greater transparency, we began a process of sharing information about theoutbreaks the FDA is investigating through a weekly outbreak update table, even before there is any actionable information. And importantly, we completed an independent review of our outbreak investigation processes that led to the development of a Foodborne Outbreak Response Improvement Plan.

I want to THANK all of those in the FDA who have committed themselves to these efforts and I hopethat they are given the opportunity to continue this important work in the future. I hold the foodsafety staff throughout the agency in the highest regard, for their expertise, their experience, and –most of all – their commitment to the public.

Looking to the Future

In February 2022, as you rejoined the agency, I shared with you that I was considering leaving,expressing my concern that the decentralized structure of the foods program that you and I bothinherited, significantly impaired FDA’s ability to operate as an integrated food team and protect thepublic.

It was also in February of 2022 that I first learned of the infant formula incidents the had beenreported to various parts of the FDA several months before, so I postponed this decision anddedicated myself and my staff to doing all we could to help tackle this crisis. With the Abbott facilitynow reopened, infant formula availability more prevalent, and – very importantly – the necessarymonitoring, data systems, and insights now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave and vacate this position.

My fervent hope is that American consumers, especially mothers and fathers of infants, never againhave to face this type of preventable situation. It is incumbent on any public organization that hasundergone a crisis of this magnitude to undergo an independent and thorough review to understand how the crisis happened, what can be done to prevent it from happening again, and that the findings be transparently shared with the public. I am grateful that Congressional leaders have demanded that this happen and that the Office of the Inspector General has initiated its owninvestigation.

Lastly, while I respect that these are decisions only you can make, I do want to leave you with acouple of points for consideration. One, based on my experience these past four years, I (as well asa diverse group of Bipartisan Congressional Leaders and Consumer, State Regulatory, & IndustryStakeholder Groups) firmly believe the agency would operate more effectively and be better able toprotect the American public from foodborne illness, with the creation of a more integratedoperating structure and a fully empowered and experienced Deputy Commissioner for Foods, withdirect oversight of those centers and offices responsible for human and animal foods. In thismanner, she or he can more easily make the necessary changes that are needed to transform FDA’sFood Program for the 21st Century. Secondly, I also urge you to consider transferring the small, yet exceptional staff comprising the Office of Food Policy and Response (OFPR) to a new office of theDeputy Commissioner for Foods.

In closing, I will always remain grateful for the opportunity to have served our one and only trueboss, the approximate 340 million American consumers nationwide. Serving them has been a honor and privilege.

Frank Yiannas

Deputy Commissioner, Food Policy and Response

In the 30 years since the Jack in the Box outbreak, food safety has come a long way. Here are some of the people who have shaped it.

JANUARY FEBRUARY 2023 – https://www.qualityassurancemag.com/article/the-food-safety-set/

Row 1: Caroline Smith DeWaal, James Marsden, Darin Detwiler, Rosa DeLauro. Row 2: Frank Yiannas, Ann Marie McNamara, Dick Durbin, Bill Marler. Row 3: Mike Taylor, Craig Wilson, Sandra Eskin, Bill Keene

Food Safety Over the Last 30 Years

By Steven Mandernach, executive director, Association of Food and Drug Officials

When I talk to food safety leaders across the country and from around the world, we often discuss what has changed, how things are different. Many pathogens are the same: SalmonellaE. coli and Listeria monocytogenes continue to be persistent foodborne illness pathogens of concern, though significant progress has been made with all. Many, such as Cyclospora, norovirus and Hepatitis A, were largely unknown as potential foodborne illnesses. Produce and eggs were not known vehicles for illness, yet they have dominated much of the last 30 years of illnesses. In 1992, we hadn’t really thought that what happens at the farm level can affect food safety throughout the supply chain. 

Thirty years ago, a food safety professional’s work often focused on cleanliness and hygiene, but today, it’s more focused on process and prevention. Our facilities and establishments now often have and are required to have HACCP or food safety plans along with well-developed standard operating procedures. Further, we recognize that much of food safety isn’t necessarily based in microbiology, but rather soft “power” skills such as human behavior. 

Technologically speaking, cell phones were a thing of Hollywood 30 years ago, computers were somewhat rare, and handheld devices were on Star Trek, not found in the real world. Today, we are in an age of instant communication, and information expectations are immediate for everyone in the food chain, including the farmer, consumer and regulator. Further, laboratory testing that may have taken weeks or longer now often takes hours or only minutes. Also, we are regularly using DNA fingerprinting, which has advanced greatly since 1992, to identify smaller and smaller clusters for outbreaks. Many outbreaks now can be solved in days rather than weeks or months. 

Today, like then, we have many curious food safety professionals asking questions and advancing the body of knowledge. We have many areas that require yet more research, for example, on the transmission of pathogens through produce. Knowledge of Cyclospora remains tiny, and we have yet to find the silver bullet for human behavior, which is likely the most challenging component of food safety. 

One common factor across the past 30 years is people. We have had talented people and policy makers in industry, academia, regulatory, public health and consumer groups who have been unwilling to accept the status quo. These passionate food safety leaders insisted on and expected food safety to improve with knowledge, and they pushed to develop the knowledge where none existed. Work by these leaders has nearly eliminated some pathogens such as botulism, made significant reductions in others and kept the spotlight and focus in the public and C-suite on food safety. 

As we reflect on the 30th anniversary of the Jack in the Box E. coli outbreak, which in so many ways provided increased awareness of foodborne illness, we need to celebrate the people who have helped improve the safety of our national and global food supplies. These people have persevered where their message was often unpopular and expensive, and they managed to truly impact our world. 

These leaders would likely tell the emerging food safety leaders a few important things. 

  • You will always want more information than is available — but react with prevention and mitigation in mind, rather than complete certainty.
  • Not everything works. Periodic failures and persistence lead to successes.
  • Think, hypothesize, experiment and try: These actions result in improvements in food safety and the reduction of illness.
  • Build a community: Nothing can be accomplished alone. Everything requires friends, colleagues, critics and others.
  • Mentor and collaborate with others to build the next community of leaders.

Most importantly, though, do what’s right to prevent human illness. These leaders featured in the following pages can each be credited with work that improved food safety and further limited or reduced human illness. Food consumers — all of us — thank them for their courage, leadership and persistence in making food safer and reducing foodborne illness.


In the 30 years since the 1992-93 Jack in the Box E. coli outbreak, food safety policies, advocacy and research have come a long way. While there’s still more to be done, here are some of the people who have helped shape the last 30 years of food safety. 

Rosa DeLauro, The Representative

Rosa DeLauro, U.S. representative for Connecticut’s third congressional district since 1991, has long been vocal about food safety. She was a key leader in writing the Food Safety Modernization Act (FSMA), signed into law in 2011. She championed regular inspections of high-risk industrial food facilities, food companies taking preventive measures, a better system for tracing food and imported food meeting U.S. safety standards. In July 2022, she and Sen. Dick Durbin (also a member of The Food Safety Set) introduced the Food Safety Administration Act, legislation that would establish the Food Safety Administration, a single food safety agency responsible for keeping the food Americans consume safe for market. She and Durbin have advocated for streamlining the country’s food safety system since 2015. 


Darin Detwiler, The Professor 

Darin Detwiler didn’t have to take up the foodborne illness cause after his son, Riley, died in 1993 due to E. coli as part of the Jack in the Box outbreak. But the former U.S. Navy submariner turned tragedy into an opportunity to advocate and educate, working with groups such as IAFP and STOP Foodborne Illness and advising government agencies such as FDA and USDA. With more than 20 years’ teaching experience, he’s currently an associate teaching professor of regulatory affairs of food and food industry at Northeastern University. He’s received many awards, including IAFP’s Ewen C.D. Todd Control of Foodborne Illness Award in 2022. It’s all been part of an effort to help prevent more deaths such as Riley’s. “If 3,000 families are dealing with [foodborne illness] every year, that’s 90,000 families since my son died,” he told us in 2021. 


Nancy Donley, The Advocate 

After the death of her son, Alex, in 1993 due to E. coli, Donley dedicated herself to extensive advocacy with STOP Foodborne Illness, including serving as the organization’s president. She worked collaboratively with federal food safety agencies, industry, academia and other consumer groups in advancing stronger food safety practices and policies. Donley participated in numerous media interviews in efforts to build awareness of foodborne risk and educate the public on how best to protect themselves. Among other awards, Donley received NSF International’s 2011 International Lifetime Achievement Award for her “extraordinary efforts, outstanding dedication, and endless passion for food safety.” 


Dick Durbin, The Reformer 

Now in his fifth term, Sen. Dick Durbin of Illinois co-authored the FDA Food Safety Modernization Act — signed into law in 2011 and described by FDA as the most comprehensive food safety reform in 70 years — after receiving a letter from the mother of a child who died in 1993 after eating a hamburger contaminated with E. coli. Most recently, in July 2022, he and former Chair of the House Appropriations Committee Rosa DeLauro (also a member of The Food Safety Set) introduced the Food Safety Administration Act, legislation that would establish the Food Safety Administration, a single food safety agency responsible for keeping the food Americans consume safe for market. Durbin and DeLauro have argued in favor of consolidating the country’s food safety functions into one independent agency since 2015.


Sandra Eskin, The Consultant 

Sandra Eskin, deputy under secretary for food safety at the United States Department of Agriculture (USDA), spent nearly 20 years as a public-policy consultant to numerous consumer advocacy and public-interest organizations, providing strategic and policy advice on consumer protection issues such as food safety, dietary supplement safety and food and drug labeling and advertising. Prior to joining USDA, she was project director for food safety at The Pew Charitable Trusts. She currently oversees the Food Safety and Inspection Service (FSIS), which last year proposed regulatory framework for a new strategy to control Salmonella contamination in poultry products. Aside from her food safety work, she is also an award-winning children’s playwright. 


Bill Marler, The Lawyer

Bill Marler is recognized as one of the most prominent foodborne illness lawyers in America and a major force in food policy in the U.S. and around the world. He began litigating foodborne illness cases in 1993 and has since represented victims of nearly every large foodborne illness outbreak in the U.S. “If you do everything you can to prevent illness, you’re likely to prevent illness,” he told QA magazine in 2020. “And if that’s not something you think is doable, then maybe you’re not in the right business.” Marler’s advocacy for a safer food supply includes petitioning the USDA to better regulate pathogenic E. coli, working with nonprofit food safety and foodborne illness victims’ organizations and helping spur the passage of FSMA. 


Bill Keene, The Epidemiologist 

Bill Keene was a senior epidemiologist who, prior to his death in 2013, dedicated 23 years to the Oregon Health Authority’s Acute and Communicable Disease Prevention section. He and his team were able to trace the origins of numerous foodborne illnesses across the nation, including a 2008 Salmonella outbreak involving jalapeño peppers that sickened more than 1,200 and killed two people. Keene had a remarkable impact on the field of food safety and was known around the world for his persistence, curiosity and enthusiasm for fieldwork. Considered by many, including USA Today, as one of the nation’s foremost food safety sleuths, his work likely saved countless lives. Keene created the International Outbreak Museum in Portland, Ore. 

James Marsden, The Problem Solver

James Marsden was enlisted to turn the food safety program around at Chipotle Mexican Grill in 2016 following a series of norovirusE. coli and Salmonella outbreaks at various Chipotle locations. No stranger to crisis, Marsden, who has over 40 years of experience in the industry, previously served as vice president of scientific and technical affairs at the American Meat Institute, working to improve the meat inspection process following the 1993 Jack in the Box E. coli outbreak. A retired Kansas State University professor of meat science for 21 years, Marsden’s research focused on the safety of meat products and food safety training for the meat industry. Fun fact: he is father to actor James Marsden of “Enchanted” and “X-Men” fame. 


Ann Marie McNamara, The Industry Stalwart 

Currently the vice president of food safety and quality for supply chain at US Foods, Ann Marie McNamara’s other notable leadership roles include vice president of food safety and regulatory compliance at Jack in the Box, director of the microbiology division at USDA’s FSIS and more. She co-authored USDA’s Pathogen Reduction/HACCP rule that, for the first time, required microbiological testing and a risk-based approach to controlling hazards in foods. In 2022, IAFP presented her with their Food Safety Award in recognition of her long history of outstanding contributions to food safety research and education. McNamara delivered IAFP’s 2018 John H. Silliker Lecture, speaking on the topic of “Heroes Past and Future.” 


Caroline Smith DeWaal, The International Activist

Caroline Smith DeWaal founded Safe Food International in 2004, where she helped develop guidelines for consumer organizations to promote national food safety systems, as well as an information resource to track food outbreaks in multiple world regions to identify emerging trends and public health priorities. For 21 years, she was the director of food safety at the Center for Science in the Public Interest, where she directed policy formulation and execution on food safety issues and made numerous appearances before congressional committees to deliver testimony on food safety issues. She then spent five years as FDA’s International Food Safety Policy Manager, coordinating international projects and leading negotiations with foreign governments. She is now deputy director of EatSafe, working to improve food safety in countries with high rates of foodborne illness. 


Trevor Suslow, The Produce Safety Specialist 

As one QA advisory board member put it, Trevor Suslow “has been at the forefront of the research on food safety for leafy greens and is a driving force behind the food safety standards for produce. He’s smart, innovative and someone who is respected by industry, academia and regulators.” Suslow helped found DNA Plant Technology Corp. before joining the faculty at University of California-Davis, teaching and leading research around the safety and quality of whole and fresh-cut produce. Suslow also served as vice president of food safety at the Produce Marketing Association for two years. He’s been recognized for his impact, receiving IAFP’s 2018 Elmer Marth Educator Award and the 2019 IAFP President’s Recognition Award. 


Dr. Robert Tauxe, The CDC Constant 

Dr. Robert Tauxe first joined the CDC in 1985, where he played a role in foodborne illness outbreaks such as the 2008 jalapeno Salmonella outbreak. He also helped develop PulseNet, a network of state public health departments across the U.S. to keep track of E. coli O157 and other foodborne illness pathogens. “Because of PulseNet, we’re able to identify outbreaks sooner than we used to,” he told PBS back in 2002. “And we’re able to identify a new category of outbreaks that we never would have identified before.” Tauxe holds faculty appointments at the Emory University School of Public Health in the Department of International Health as well as the Emory University Department of Biology. He has authored or co-authored more than 250 scientific journal articles, letters and book chapters. After retiring from the agency in 2008, he stayed on as a civilian employee. 


Mike Taylor, The Consumer Advocate 

As administrator of the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), Mike Taylor was the government official who, after the deadly Jack in the Box outbreak, ruled that the pathogen E. coli is an adulterant in meat. He helped establish a new food safety regulatory program to prevent foodborne illness from meat and poultry in response to the outbreak. He was Deputy Commissioner for Foods and Veterinary Medicine at FDA for six years, where he oversaw implementation of the Food Safety Modernization Act (FSMA). He currently co-chairs the board of STOP Foodborne Illness, a nonprofit consumer advocacy group that supports victims of foodborne illness and their families in efforts to strengthen food safety culture and practices in government and industry. 


Dave Theno, The Crusader 

Dave Theno became head of Jack in the Box’s food safety shortly after the 1992-1993 E. coli outbreak and is credited by many with having saved the company. Theno’s prior positions include food safety and quality programs at Armour Food, Kellogg’s, Foster Farms and his own consulting company. Food safety industry veteran Bruce Ferree once wrote that Theno often said, “Food safety is not a competitive advantage. We need to share and work together to achieve this level of success.” His leadership in industry-wide improvement in food safety is recognized by many, including posthumously through the Dave Theno Food Safety Fellowship at STOP Foodborne Illness. 


Craig Wilson, The Retailer 

Craig Wilson’s title is probably longer than yours. He’s vice president, general merchandising manager of quality assurance/food safety, non-foods product safety and quality assurance, environmental services/HAZMAT and merchandise services for Costco Wholesale Corp. So, imagine having to say or write that out every time he gives a keynote address or joins an industry board, both of which happen a lot. Aside from numerous appearances at events such as the Food Safety Summit, Wilson has served on the steering committee for the National Food Safety Consortium and the technical committee at the Global Food Safety Initiative. And he’s not just a good talker. Wilson holds patents, such as one for steam pasteurization of food, and published a number of research papers covering food processing and safety. 


Frank Yiannas, The Forward Thinker 

Innovation is one of Frank Yiannas’ favorite words. He told us so himself in a 2019 QA cover story. “It’s important to advance food safety with change and innovation,” he said at the time. At each career stop he’s made, first at Walt Disney Co., then at Walmart and now at FDA, he’s helped usher in a transformation of some kind. Whether it’s food safety culture, which he’s written two books on, or traceability via blockchain, Yiannas has long advocated for and implemented technological innovations for food safety advancement and supply chain traceability and transparency and helped usher in FDA’s New Era for Smarter Food Safety. A registered microbiologist, he’s also taught as an adjunct professor at Michigan State University and received numerous industry awards, such as the 2015 Industry Professional Food Safety Hero Award from STOP Foodborne Illness.

Here are some cases where prosecutors brought criminal charges:

In 1998 in what the first criminal conviction in a large-scale food-poisoning outbreak was, Odwalla Inc. pleaded guilty to violating Federal food safety laws and agreed to pay a $1.5 million fine for selling tainted apple juice that killed a 16-month-old girl and sickened 70 other people in several states in 1996. Odwalla, based in Half Moon Bay, California pleaded guilty to 16 counts of unknowingly delivering ”adulterated food products for introduction into interstate commerce” in the October 1996 outbreak, in which a batch of its juice infected with the toxic bacteria E. coli O157:H7 sickened people in Colorado, California, Washington and Canada. Fourteen children developed a life-threatening disease (hemolytic uremic syndrome -HUS) that ravages kidneys. At the time, the $1.5 million penalty was the largest criminal penalty in a food poisoning case.  Odwalla also was on court-supervised probation for five years, meaning that it had to submit a detailed plan to the food and drug agency demonstrating its food safety precautions and that any subsequent violations could have resulted in more serious charges.

 In 2012 Eric Jensen, age 37, and Ryan Jensen, age 33, brothers who owned and operated Jensen Farms, a fourth-generation cantaloupe operation, located in Colorado, presented themselves to U.S. marshals in Denver and were taken into custody on federal charges brought by the U.S. Attorney’s Office with the Food and Drug Administration – Office of Criminal Investigation. According to the six-count indictment, Eric and Ryan Jensen unknowingly introduced adulterated (Listeria-tainted) cantaloupe into interstate commerce. The indictment further stated that the cantaloupe was prepared, packed and held under conditions, which rendered it injurious to health.  The outbreak sickened over 147, killing over 33 in 28 states in the fall of 2011.  The Jensen’s faced up to six years in jail and $1,500,000 in fines each. They eventually pleaded guilty and were sentenced to five years’ probation.

In 2013 Austin “Jack” DeCoster and his son, Peter DeCoster, both faced charges stemming from a Salmonella outbreak caused by their Iowa egg farms in 2010.  The Salmonella outbreak ran from May 1 to November 30, 2010 and prompted the recall of more than a half-billion eggs. And, while there were 1,939 confirmed infections, statistical models used to account for Salmonella illnesses in the U.S. suggested that the eggs might have sickened more than 62,000 people. The family business, known as Quality Egg LLC, pleaded guilty in 2015 to a federal felony count of bribing a USDA egg inspector and to two misdemeanors of unknowingly introducing adulterated food into interstate commerce. As part of the plea agreement, Quality Egg paid a $6.8-million fine and the DeCosters $100,000 each, for a total of $7 million.  Both DeCosters were sentenced to three months in jail.

 In 2014 former Peanut Corporation of America owner Stewart Parnell, his brother and one-time peanut broker, Michael Parnell, and Mary Wilkerson, former quality control manager at the company’s Blakely, Georgia, plant, faced a federal jury in Albany, Georgia. The 12-member jury found Stewart Parnell guilty on 67 federal felony counts, Michael Parnell was found guilty on 30 counts, and Wilkerson was found guilty of one of the two counts of obstruction of justice charged against her. Two other PCA employees earlier pleaded guilty. The felony charges of introducing adulterated food into interstate commerce, “with the intent to defraud or mislead,” stemmed from a 2008 to 2009 Salmonella outbreak that sickened 714 and left nine dead. Stewart Parnell, Michael Parnell, and Mary Wilkerson were all found guilty on multiple charges.  Stewart and Michael are spending decades in prison.

In 2015 ConAgra Foods agreed to plead guilty and pay $11.2 million in connection with the shipment of Salmonella contaminated peanut butter linked to a 2006 through 2007 nationwide outbreak of that sickened over 700. ConAgra signed a plea agreement admitting that it unknowingly introduced Peter Pan and private label peanut butter contaminated with Salmonella into interstate commerce during the 2006 through 2007 outbreak.

In 2020 Chipotle was ordered to pay $25 million to resolve criminal charges related to the company’s involvement in foodborne illness outbreaks that sickened more than 1,100 people between 2015 and 2018. Chipotle was implicated in at least five foodborne illness outbreaks between 2015 and 2018 connected to restaurants in the Los Angeles area, Boston, Virginia, and Ohio.  These incidents primarily stemmed from store-level employees’ failure to follow company food safety protocols at company-owned restaurants, including a Chipotle policy requiring the exclusion of employees who were sick or recently had been sick. For example, in August 2015, 234 consumers and employees of a Chipotle restaurant in Simi Valley, California reported becoming ill.  Although company policies required the restaurant to report certain employee illnesses to Chipotle safety officials and to implement enhanced food safety procedures, the restaurant did not pass along information regarding an ill employee until multiple consumers already had reported being sick. In December 2015, a norovirus incident at a Chipotle restaurant in Boston sickened 141 people.  According to the DPA, that outbreak likely was the result of an ill apprentice manager who was ordered to continue working in violation of company policy after vomiting in the restaurant.  Two days later, the same employee helped package a catering order for a Boston College basketball team, whose members were among the consumers sickened by the outbreak. In July 2018, approximately 647 people who dined at a Chipotle restaurant in Powell, Ohio reported illness related to Clostridium perfringens, a pathogen that grows rapidly when food is not held at appropriate temperatures.  The local health department found critical violations of local food regulations, including those specific to time and temperature controls for lettuce and beans.

In 2020 Blue Bell pleaded guilty in May 2020 to two misdemeanor counts of distributing adulterated ice cream products.  The sentence, imposed by U.S. District Judge Robert Pitman in Austin, Texas, was consistent with the terms of a plea agreement previously filed in the case.  The $17.25 million fine and forfeiture amount is the largest-ever criminal penalty following a conviction in a food safety case. In March 2015, tests conducted by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) linked the strain of Listeria in one of the Blue Bell ice cream products to a strain that sickened five patients at a Kansas hospital with listeriosis, the severe illness caused by ingestion of Listeria-contaminated food.  The FDA, CDC, and Blue Bell all issued public recall notifications on March 13, 2015.  Subsequent tests confirmed Listeria contamination in a product made at another Blue Bell facility in Broken Arrow, Oklahoma, which led to a second recall announcement on March 23, 2015. According to the plea agreement with the company, FDA inspections in March and April 2015 revealed sanitation issues at the Brenham and Broken Arrow facilities, including problems with the hot water supply needed to properly clean equipment and deteriorating factory conditions that could lead to insanitary water dripping into product mix during the manufacturing process.  Blue Bell temporarily closed all of its plants in late April 2015 to clean and update the facilities. Since re-opening its facilities in late 2015, Blue Bell has taken significant steps to enhance sanitation processes and enact a program to test products for Listeria prior to shipment. Paul Kruse, President and CEO of Blue Bell Ice Cream, is faced a felony trial in 2022. 

So, what gives the government the right to charge a company and certain employees with either a felony or a misdemeanor?

Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.  Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health.  The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.

Abbott Under Federal Criminal Investigation Over Baby Formula

Michigan plant at center of probe was temporarily closed by the company last year after potentially deadly bacteria was found. https://www.wsj.com/articles/abbott-under-criminal-investigation-over-baby-formula-11674255871?mod=business_lead_pos1

The Justice Department is investigating conduct at the Abbott Laboratories infant-formula plant in Sturgis, Mich., that led to its shutdown last year and worsened a nationwide formula shortage, people familiar with the matter said.

Attorneys with the Justice Department’s consumer-protection branch are conducting the criminal investigation, the people said. 

The branch, which has criminal as well as civil authority, was involved last year in a settlement with Abbott that allowed its Sturgis plant to resume operations after Food and Drug Administration inspectors found a potentially deadly bacteria there. 

“The DOJ has informed us of its investigation, and we’re cooperating fully,” an Abbott spokesman said.

The investigation signals further scrutiny of Abbott’s operation of the plant, a major source of baby formula in the U.S., and perhaps of the more than $4 billion formula industry.

The Justice Department in the past decade has investigated numerous food companies that have shipped contaminated products that resulted in illnesses or deaths. 

Several have led to criminal prosecutions under the 1938 Federal Food, Drug and Cosmetic Act of companies or executives involved in producing goods from ice cream to peanut butter. The law allows government officials to prosecute entities or individuals who introduce adulterated food into interstate commerce.

In many recent cases, DOJ has been able to successfully prosecute defendantson misdemeanor charges for introducing contaminated food into the market even without proof that officials acted with criminal intent, according to Bill Marler, a Seattle lawyer who represents victims of food-borne illnesses.  

Abbott, based outside Chicago, is one of the biggest manufacturers of baby formula. The company sells Similac, among other brands.

Last January, FDA inspectors found bacteria at the plant after receiving reports of babies who drank the company’s formula and became sick. The inspectors also found standing water, damage to drying equipment and defects in the seams of formula cans, among other problems at the Sturgis plant. 

Federal officials couldn’t conclusively link the bacteria at the plant to the infants’ illnesses, however. Abbott has said genetic sequencing of the bacteria in the sick babies didn’t match the strains found at the plant.

Abbott temporarily halted production at the Sturgis factory in February, and recalled baby formula made at the plant. The moves contributed to an infant formula shortage that sent parents and federal officials scrambling for months.

To bolster supplies, the federal government waived regulatory requirements and tariffs to allow more foreign formula into the country, and the White House organized planes to fly baby formula to the U.S. 

Abbott last May signed a legal agreement, called a consent decree, detailing the steps it would need to take to reopen the plant. 

In the complaint accompanying that civil agreement, the Justice Department said Abbott and several of its employees had caused “adulterated food” to enter interstate commerce.

“Ongoing inadequacies in manufacturing conditions and practices at Defendants’ facilities demonstrate that Defendants have been unwilling or unable to implement sustainable corrective actions to ensure the safety and quality of food manufactured for infants, a consumer group particularly vulnerable to foodborne pathogens,” the department said in the complaint.

In May I wrote:

According to the CDC and FDA, at least 4 kids were sickened and of those two died, from drinking Abbott infant formula.  Abbott denies the connection.  However, the resulting investigation and inspection (and whistleblower documents) uncovered enough problems in the Abbott facility to shutter it causing havoc with supplies of infant formula.  The facility is now set to reopen, but not before the U.S. Attorney sued Abbott and several employees. In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements.

Abbott is essentially confessing to the violations in the below consent decree. Under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law. It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected. The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs.

Here are the key documents:

Here is the 2021 inspection report at the plant – APPLIED – FOI II – BR Abbott Nutritions- FEI# 1815692 9-2021 EIR.

Here are the whistleblower documents – Redacted Confidential Disclosure re Abbott Laboratories – 10-19-2021_Redacted (1)

Here is the 2022 inspection report at the plant – Updated Final Applied_Unapplied Redactions Abbott Nutrition Sturgis FEI 1815692 FDA 483 1-31022 to 3-16-22 – ISSUED_Redacted

Here is the complaint – abbott_complaint_0

Here is the consent decree – abbott_proposed_consent_decree_0

Please read the above and ask the question: is this how infant formula should have been manufactured?

So, what gives the government the right to charge a company and certain employees with either a felony or a misdemeanor?

Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.  Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health.  The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.

The legal jargon aside, if you are a producer of food and knowingly or not manufacturer and sell adulterated food, you can (and should) face fines and jail time.