Public Meeting Registration and Online Stakeholder Portal Now Open

The Reagan-Udall Foundation has opened a Stakeholder Portal to collect perspectives and experiences with FDA’s human foods program. In addition, the Foundation announced a public meeting of its food-focused Independent Expert Panel. 

The Expert Panel wants to hear directly from stakeholders,” said Jane E. Henney, MD, Chair of the foods Independent Expert Panel. “We want to hear firsthand observations about both the strengths and challenges the program faces as well as ideas on how to best prepare for the regulatory landscape of the future.”  

The portal allows all stakeholders to share their insights about what is working in FDA’s human foods program, the challenges it faces, and suggestions to improve program operations. Comments received through the Stakeholder Portal will be shared with the Independent Expert Panel charged with generating the recommendations for FDA. 

On September 29-30, the Reagan-Udall Foundation will facilitate a public meeting of the Independent Expert Panel on food. Invited stakeholders will provide feedback on critical topics such as Nutrition Initiatives, Food Safety, Intra-Federal Relations, Federal-State Relationships, Resources, and Positioning FDA for the Future. A limited number of seats are available to stakeholders who wish to observe the in-person meeting to be held in Washington, DC. To expand access, audio streaming will also be available.  

The operational evaluation focuses on the structure/leadership, authority, resources, and culture of FDA’s human foods program. The 60-business-day review will culminate in recommendations that will be submitted on December 6, 2022, to Dr. Robert Califf, Commissioner of Food and Drugs, at FDA

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A new outbreak of infections from Listeria monocytogenes has been reported by the FDA, bringing the agency’s number of open investigations to 10.

The Food and Drug Administration reports that it has begun on-site inspection and sample testing, but it has not found a specific source for the Listeria. It has not initiated traceback efforts. The agency reports there are six confirmed patients in the outbreak, but has not revealed their ages or the states where they live.

In other outbreak news, the patient count in an outbreak caused by Salmonella Mississippi has increased to 102 from the 100 patients reported a week ago.  The agency has not made public where the patients live or their ages. The FDA has not identified a source of the pathogen but has initiated traceback efforts. The agency has not reported what food or foods are being traced.

Other outbreaks with active FDA investigations

  • For a Salmonella Senftenberg outbreak from a not yet identified food, the patient count is steady at 27. Traceback has begun but FDA has not reported what is being traced.
  • For a Salmonella Typhimurium outbreak from a not yet identified food, the patient count is steady at 78. Traceback, on-site inspection and sample analysis has been initiated, but the FDA has not reported what is being traced or tested or where the inspection is taking place.
  • For a Cyclospora outbreak the patient count remains steady 79. Traceback has begun but the FDA has not reported what is being traced.
  • For another Cyclospora outbreak the patient count has remained steady at 42. Traceback has begun but the FDA has not reported what is being traced. Similarily, sample testing has begun but the agency has not reported what is being tested. 
  • An investigation related to adverse effects associated with Daily Harvest brand frozen Leeks & Lentils Crumbles is ongoing. The company has received more than 470 complaints of illnesses and as of its most recent report on July 29 the FDA had received 329 complaints. Some of the patients have gone into liver failure and at least 25 have had to have their gallbladders removed. The FDA is working on traceback efforts and has begun on-site inspection and product testing. Some testing has revealed that tara flour is an ingredient unique to the Daily Harvest crumbles product and could be related to the illnesses.
  • In an ongoing outbreak of infections caused by E. coli O157:H7 the FDA has initiated sample collection and analysis. The outbreak, reported by the CDC as being linked to lettuce on Wendy’s sandwiches, has sickened at least 84 people. The four-state outbreak has sickened more people according to the state counts, but all of the reports have not reached the CDC. Wendy’s has stopped serving the romaine-iceberg lettuce hybrid on sandwiches in several states, according to a statement from the company.
  • The FDA is conducting an on-site inspection at Big Olaf Creamery in Florida, which has been deemed to be behind an 11-state outbreak of Listeria infections. The state of Florida closed the business several weeks ago after tests found multiple places of contamination with Listeria monocytogenes in the plant. Testing also showed Listeria in 16 of 17 flavors of the company’s ice cream. At last count the outbreak had sickened 25 patients with one having died. A pregnant woman also miscarried. Twenty-four of the patients have required hospitalization.
  • An outbreak of infections from Cronobacter in four infants, two of whom died. The outbreak has been determined to be over by the CDC but is it still under investigation. The babies consumed infant formula made by Abbott Nutrition’s plant in Sturgis, MI.

The December 2017 Cluster 

In late 2017, three cases of E. coli O157:H7 were reported in Wisconsin. These Wisconsin cases were found to have genetic fingerprints that matched each other, which was an essentially definitive signal to investigating epidemiologists that the cases of illness had a common source. Wisconsin state health officials determined that this cluster was likely sickened by a contaminated mixed green salad served at an unidentified school. 

The three Wisconsin cases were classified as part of a CDC cluster (CDC Cluster Code: 1801MLEXH-1). This cluster soon grew to definitively include numerous cases from other states (Arizona, California, Maine, Michigan, New Jersey, Nevada, New York, Utah, Washington, and Wisconsin). Ultimately, the cluster included approximately 17 cases from ten states, all of whom had experienced an onset of symptoms from November 6, 2017, to January 9, 2018. 

Genetic analysis conducted by the CDC on the “isolate” (i.e., the E. coli O157:H7 bacteria isolated from her stool sample) showed that her illness was a genetic match to the cluster that originated in Wisconsin. The client was, therefore, definitively included as a confirmed case in this ten-state cluster of E. coli O157:H7 illnesses, as is set forth in the CDC’s official “line list” (i.e., chart of all confirmed cases in a cluster), which is reproduced below: 

The Spring 2018 E. coli O157:H7 Cluster 

Not long after the 1801MLEXH-1 cluster occurred, 240 E. coli O157:H7 cases from 37 states were identified in one of the largest ever E. coli outbreaks linked to the consumption of contaminated romaine lettuce. Due to its sheer size, this outbreak investigation demanded significant federal resources, including thorough epidemiologic and environmental investigations by CDC and FDA. Almost all the confirmed cases in this outbreak, known by CDC Cluster Code 1804 MLEXH-1, occurred from March 13 through early May 2018. 

The critical findings from the 2018 cluster were as follows: 

·  The 2018 cluster involved an identical strain, by genetic analysis, to the late 2017 cluster; 

·  CDC’s epidemiologic investigation conclusively identified romaine lettuce grown in the Yuma, Arizona growing region as the source of the outbreak; 

·  The E. coli strain involved in the 2018 cluster originated at an extremely large Centralized Animal Feeding Operation (CAFO) located in Wellton, Arizona (cattle are overwhelmingly the predominant animal source of E. coli O157:H7); 

·  The E. coli strain involved in the 2018 cluster was found in three different water samples from an irrigation canal that flows along the border of the CAFO in Wellton, Arizona. 

The Yuma, Arizona Growing Region 

In the past, lettuce from the Yuma growing region has been the source of several E. coli outbreaks.

Not surprisingly, the FDA, in its complete “Environmental Assessment of Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in a Multi-State Outbreak of E. coli O157:H7” concluded that the risk of environmental contamination associated with the 1804MLEXH-1 outbreak was, in fact, a persistent risk likely associated with past outbreaks, as well: 

Food safety problems related to raw whole and fresh-cut (e.g., bagged salad) leafy greens are a longstanding issue. As far back as 2004, FDA issued letters to the leafy greens industry to express concerns about continuing outbreaks associated with these commodities. FDA and our partners at CDC identified 28 foodborne illness outbreaks of Shiga-toxin producing E. coli (STEC) with a confirmed or suspected link to leafy greens in the United States between 2009 and 2017. This is a time frame that followed industry implementation of measures to address safety concerns after a large 2006 outbreak of E. coli O157:H7 caused by bagged spinach. 

STEC contamination of leafy greens has been identified by traceback to most likely occur in the farm environment. 

Contamination occurring in the farm environment may be amplified during fresh- cut produce manufacturing/processing if appropriate preventive controls are not in place. Unlike other foodborne pathogens, STEC, including E. coli O157:H7, is not considered to be an environmental contaminant in fresh-cut produce manufacturing/processing plants. 

In its summary of its environmental findings, the “FDA (in part) identified the following factors and findings as those that most likely contributed to the contamination of romaine lettuce from the Yuma growing region with E. coli O157:H7 that caused [the 1804MLEXH-1 outbreak]”: 

• FDA has concluded that the water from the irrigation canal where the outbreak strain was found most likely led to contamination of the romaine lettuce consumed during this outbreak. 

• There are several ways that irrigation canal water may have come in contact with the implicated romaine lettuce, including direct application to the crop and/or use of irrigation canal water to dilute crop protection chemicals applied to the lettuce crop, either through aerial or ground-based spray applications. 

• How and when the irrigation canal became contaminated with the outbreak strain is unknown. A large animal feeding operation is nearby, but no obvious route for contamination from this facility to the irrigation canal was identified. Other explanations are possible, although the EA team found no evidence to support them. 

Some might have heard that the FDA Commissioner has instituted a review on how the FDA, and it’s Food Safety arms or organized. Setting aside that it might be a good idea to create a single food safety agency with all the parts of USDA and FDA, etc., in one place, perhaps we can at least go back to the way things were in the Obama Administration.

Any brilliant ideas? Here is the 2022 organization chart of the FDA:

By the way, here is the 2022 organization chart of the USDA:

In the first 10 years of my practice, 90% of the cases I did were E. coli cases linked to ground beef. Hemolytic Uremic Syndrome (HUS) was called the “Hamburger Disease.” It took several years after deeming E. coli O157:H7 an adulterant in ground beef for industry, government, retailers and consumers to bend the curve.

I just hope we have not gotten too confident.

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that ground beef products in HelloFresh meal kits may be associated with Escherichia coli (E. coli) O157:H7 illness. A recall was not requested because the products are no longer available for purchase.

The meal kits containing ground beef for this public health alert were shipped to consumers from July 2-21, 2022. The following products are subject to the public health alert:     

  • 10-oz. plastic vacuum-packed packages containing “GROUND BEEF 85% LEAN/15% FAT” with codes “EST#46481 L1 22 155” or “EST#46481 L5 22 155” on the side of the packaging.

 The ground beef packages bear “EST.46841” inside the USDA mark of inspection and on the plastic ground beef package.

FSIS, the Centers for Disease Control and Prevention, and state public health partners are investigating an outbreak of E. coli O157:H7 and raw ground beef is the probable source of the reported illnesses. Traceback information identified that multiple case-patients received ground beef produced at establishment M46841 and distributed by HelloFresh in meal kits from July 2-21, 2022. Traceback of materials used to produce the ground beef is ongoing and FSIS continues to work with suppliers and public health partners on the investigation.

FSIS is concerned that some product may be in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away.

Perhaps the FSIS Outbreak Response will move from suspect to confirmed.

Buitoni affair: new testimonies overwhelm management

The testimonies of several employees of the Buitoni factory in Caudry shed light on the health deficiencies observed in their factory. They denounce a reduction in cleaning time imposed in 2015 and a change of flour in 2021. Investigation by Laetitia Cherel, investigation unit of Radio France.

Employees of the Buitoni site in Caudry denounce serious health deficiencies in their factory.

First, there is a sense of guilt. “ We think, we no longer sleep. We wonder how we got here. What did we do wrong?” The features drawn, Pierre * (an employee of the Caudry factory (North) where the Fraîch’Up pizzas of the Buitoni brand contaminated with Escherichia coli were manufactured) today feels the need to indulge. Since the scandal broke, he feels “responsible somewhere” for what happened. A feeling shared by several of his colleagues, including Patrick*: “ These pizzas were our life, our pride, he explains in a strangled voice . Our pride has turned into shame.”

Then there is the shock of the closure of the factory in which they and other employees have sometimes worked for several decades. On April 1, an order from the Nord prefecture ordered production to be halted “until compliance with hygiene regulations”. Patrick, Pierre and their colleagues then go around in circles. They continue to receive their remuneration but worry about their future.

Finally, there is the need to give their version of the facts on the “serious shortcomings” pointed out in the decree of the Nord prefecture to justify the closure of the factory. These shortcomings, the employees do not dispute. But they want to explain themselves. It is for all these reasons that, along with other colleagues, they agreed to speak to the Cellule investigation de Radio France.

Excerpts from the prefectural decree dated April 1, 2022.

Minimize non-production time

They specify from the outset that they have no information on the origin of the contamination. A judicial inquiry is underway to help understand the causes of the poisoning which claimed 56 victims, including 55 children aged 1 to 15, and which caused the death of two of them.

The investigation nevertheless revealed shortcomings in the management of the plant. These had already been pointed out by the DGCCRF (General Directorate for Competition, Consumer Affairs and Fraud Prevention) in three reports dating from 2012 , 2014 and 2020 (as revealed by the online investigative media Disclose ). We then discovered the presence of mold, rust and flaking paint in the factory, as well as food moths on the production line of Fraîch’Up pizzas.

The accounts of the employees shed light on these abuses. “In 2012, Nestlé implemented a new way of managing the site. This is called the Lean method, explains Maryse Tréton of the CGT agrifood federation. The objective is to reduce as much as possible all the time that is not dedicated to production. We reduce cleaning times and preventive maintenance times to maximize production.”

Three years later, in 2015, this reduction in cleaning time will be included in a so-called “competitiveness” plan. “Until 2015, the factory operated with 16 hours of production and 8 hours of cleaning per day, specify Patrick and Pierre. After 2015, we almost double the production time to reach 27 hours a day (in three shifts of 9 hours) and we almost halve the cleaning time, which goes from 8 hours to 4 hours 45 minutes.”

“The general condition has deteriorated”

According to them, the consequences of this reorganization are not long in coming: “ For us, that meant going faster on cleaning. So the priority was to clean the production line and the machines. But not what was around, like for example the walls and the ceilings. It was no longer possible to do everything.” Asked about this point, the management of Nestlé France confirms that the cleaning time is now less than 5 hours. But it specifies that it has “ systematic microbiological samples taken in different strategic areas of the site”.

This reduction in cleaning time would have had other consequences. According to the employees whom the Cellule investigation of Radio France met, certain zones of the factory which were cleaned at least once a year before 2015, would not be any more. “Before, explains one of them, we closed the factory for three weeks in August. During this time, the cleaning company that had a contract with the factory could do deep cleaning. Since then, Nestlé only wants to stop the factory for a single week in the summer. So the general condition has deteriorated.”

27 degrees due to clogged air conditioning

In the bakery workshop where the dough for the Fraîch’Up pizzas is made, “ before 2015, the air conditioning ducts were cleaned every six months to a year, explains Pierre. Now, it is no longer done and it is clogged. When it is 40 degrees outside, as there is sheet metal on the roofs, the temperature rises very high in the workshop, it is very hot, it can go up to 27 degrees.” Gilles Salvat, Deputy Director General of the Research and Reference Center of ANSES, the National Agency for Food Safety, specifies:“Products such as flour that come in powder form create dust in the factory environment which then clogs these filtration sleeves. They have to be taken apart and cleaned much more regularly. Otherwise, the operation of the air conditioning and ventilation systems is impaired. The consequence of this alteration can be, according to the scientist, a rise in temperature which leads to a risk of rapid development of Escherichia coli bacteria, even if there is nothing to confirm that this is what happened in the Buitoni factory.” Asked specifically about this point, the management of Nestlé France did not respond.

Flour silos not cleaned for seven years

Sanitation in other areas of the factory apparently left something to be desired. These are the silos, these four giant factory towers that are very visible from afar, and which each store 25 tonnes of flour. “Before, they were cleaned once a year, in August when the factory was closed. Since 2015, they have not been so to my knowledge,” says Patrick. However, according to the European guide to good hygiene practices for the storage of cereals, which we consulted, storage areas should be cleaned at least once a year.

Extract from the European Guide to Good Hygiene Practice, page 34, July 2015.

Another breach noted in the closure order issued by the prefecture: the presence of rodents in the bakery workshop. Patrick says he observed a possible crossing point for the rats: “Right next to the Fraîch’Up pizza production line , he says, there is a room where we put the raw materials. The driver [the delivery man, Editor’s note] does not close the door each time he takes a pallet off the truck. So the door stays open and rodents can get in.” Yet here again, according to Gilles Salvat, the presence of rodents is“obviously to be absolutely avoided in the food industry, because they are particularly important sources of bacterial infections, including potentially the bacterium Escherichia coli, even if it is rarely the main source” . When questioned, the management of Nestlé told us that it has made the fight against rodents a priority for several years. She specifies that she is committed to strengthening this fight with a view to restarting her factory.

A change of flour that raises questions

The track of contamination inside the factory is one of the hypotheses put forward by scientists, but it is not the only one. It is not excluded that the flour could have been contaminated before being delivered to the factory. This possibility was put forward by Christophe Cornu, the CEO of Nestlé France, in an interview with Le Figaro last July. And it is taken seriously by Éric Oswald, professor of bacteriology at the Faculty of Medicine of Toulouse Purpan. “ It wouldn’t be usual but the flour may have been contaminated with wheat soiled by spreading or manure in the fields. The bacterium is thus latent in the flour, explains the professor.And it is when this flour is going to be remixed with water and brought to temperature, that we risk having a development of the bacteria.

To deal with this eventuality, there is a type of flour that is heat-treated, that is, heated to kill bacteria. It is regularly used for the manufacture of raw pasta, more conducive to the presence of bacteria. And Buitoni, according to employees, used this type of flour until 2021 to make the dough for its Fraîch’Up range. But they claim that after this date, another non-thermally treated flour would have been used. “ At the beginning of 2021, there was a change of flour when we had been making Fraîch’Up with the same one for 20 years , we were told. We had never had a problem with this pasteurized flour. And we were told: now you are going to use a classic dough that is not pasteurized. We don’t understand why.”Asked about this point, the management of Nestlé confirmed to us that it had changed the recipe for Fraîch’Up pizzas, but without giving any details on the nature of the flour it now uses.

An alert, already at Nestlé, in the United States in 2009

And yet… In 2009 in the United States, contamination with unheated flour poisoned nearly 80 people. “The victims had eaten raw cookie dough from Nestlé’s Toll Cookie Dough brand which contained the bacterium Escherichia coli , explains Ilana Korchia, a French lawyer from the firm Marler Clark, specializing in food-borne illnesses. This firm defended 40 victims who had to be hospitalized, 10 of them developed haemolytic uremic syndrome (HUS). Ilana Korchia sees similarities in this affair with the Buitoni scandal in France: “It is the same brand, the same type of raw dough and the flour was already in question.”Following this contamination, in 2010 the American authorities classified the flour in the category of products “presenting a danger” and capable of causing epidemics of Escherichia coli. Since then, in the United States, products to be eaten raw have been made with heat-treated flour. And the mention “Safe” (“without danger”) is clearly indicated on the packaging.

*Names have been changed.

  • There are a number of Salmonella outbreak that have sickened many but have yet to be linked to a food product. The E. coli outbreak is still linked to Wendy’s, but a specific food item has not been called by the FDA, although lettuce is the prime suspect. The CDC likely will update numbers today. The FDA did close the Lucky Charms investigation without determining a causative agent. Hope that it is not the same conclusion on the ongoing – but not yet updated – Daily Harvest outbreak.
  • For the Salmonella Mississippi outbreak (ref# 1097) in a not yet identified product, the case count has increased from 99 to 100 cases.
  • For the Salmonella Senftenberg outbreak (ref# 1087) in a not yet identified food, the case count has increased from 22 to 27 cases.
  • For the Salmonella Typhimurium outbreak (ref# 1095) in a not yet identified food, the case count has increased from 73 to 78 cases.
  • For the Cyclospora outbreak (ref# 1080) the case count has increased from 75 to 79 cases.
  • For the Salmonella Braenderup outbreak (ref# 1075) the FDA investigation has closed. A product linked to illnesses was not identified.
  • The investigation associated with Dry Cereal (ref # 1064) has ended and the FDA investigation has closed with no pathogen or cause of the self-reported illnesses identified, despite extensive testing for numerous potential microbial and chemical adulterants.

The E. coli attorneys at Marler Clark filed additional lawsuits in Michigan Circuit Courts, against Wendy’s, Co., and John Doe Corporation (lettuce producer), on behalf of Zachary Nitz and Ebone Colbert-Taylor.  Both individuals became ill after eating hamburgers at Wendy’s restaurants and were positively identified as part of the multi-state Wendy’s outbreak.  The plaintiffs are represented by Marler Clark, The Food Safety Law Firm, and local counsel, Michael Heilmann. Marler Clark has also filed four individual lawsuits in Ohio.  Additional lawsuits will be brought in the coming days.  Marler Clark clients are from hard hit Michigan and Ohio as well as Indiana and Pennsylvania.

According to the CDC’s latest report:

97 Sick with E. coli O157:H7
43 Hospitalized
10 with Hemolytic Uremic Syndrome (HUS)
Age range 3 to 94
45% Female and 55% Male

We are representing 36 of the folks sickened and have filed 6 lawsuits in Ohio and Michigan so far. We have identified the grower and the shipper of the lettuce. We are working on the processor.

Since the last update on August 25, 2022, 13 more illnesses have been reported to CDC. As of August 31, 2022, a total of 97 people infected with the outbreak strain of E. coli O157:H7 have been reported from six states – Ohio, Michigan, Indiana, New York, Pennsylvania and Kentucky.

Note: The State of Ohio is reporting 24 cases, but Wood County alone is reporting 23, so the actually number for Ohio is likely 48.

Note: The State of Michigan is reporting 58 cases though the CDC, but earlier it reported at least 98, so the actual number in Michigan is at lease 100.

The CDC is reporting confirmed cases (by WGS) as follows: Indiana (11), Kentucky (1), Michigan (58), New York (1), Ohio (24) and Pennsylvania (2).

Illnesses started on dates ranging from July 26, 2022, to August 15, 2022.

Sick people range in age from 3 to 94 years, with a median age of 22 years, and 55% are male. Of 81 people with information available, 43 have been hospitalized and 10 developed hemolytic uremic syndrome, a serious condition that can cause kidney failure. No deaths have been reported.

State and local public health officials have been interviewing people about the foods they ate in the week before they got sick. Among 67 people with detailed food history, 54 (81%) reported eating at a Wendy’s restaurant in the week before their illness started. The Wendy’s restaurants where sick people ate are in Indiana, Michigan, Ohio, and Pennsylvania. People reported eating a variety of menu items, including burgers and sandwiches. Of 54 people with detailed information about what they ate at Wendy’s, 37 (69%) reported eating romaine lettuce served on burgers and sandwiches. 

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of E. coli outbreaks and hemolytic uremic syndrome (HUS). The E. coli lawyers of Marler Clark have represented thousands of victims of E. coli and other foodborne illness infections and have recovered over $850 Million for clients in the last 29 years. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation. For more information visit www.marlerclark.com.

Additional Resources:

All Lawsuits:

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The Reagan-Udall Foundation today announced five members of an Independent Expert Panel who will conduct the operational evaluation of the Food and Drug Administration’s human foods program. Dr. Jane Henney, former FDA Commissioner, was named as Chair of the panel last month. Joining Henney are Francisco Diez-Gonzalez, James Jones, Barbara Kowalcyk, Shiriki Kumanyika, and John Taylor.

“This team brings the right combination of FDA and other government experience along with deep subject matter expertise and first-hand systems and operations knowledge,” said Jane E. Henney, MD, Chair of the Independent Expert Panel. “We appreciate their commitment to developing actionable recommendations to help improve FDA’s human foods program.”

The review is set to officially launch on September 8, 2022, culminating 60-business-days later (December 6, 2022) in a report to Dr. Robert Califf, Commissioner of Food and Drugs, at FDA.

The Independent Expert Panel, charged with generating the report, is comprised of researchers, former regulators, and process improvement specialists with disciplinary expertise and experience in epidemiology, food science and safety, microbiology, nutrition, and regulatory operations.

  • Francisco Diez-Gonzalez, PhD, a food safety microbiologist, is Director of the Center for Food Safety and a Professor in the Department of Food Science and Technology at the University of Georgia’s College of Agricultural and Environmental Sciences. He conducts research aimed to control foodborne pathogens and is a member of the USDA’s National Advisory Committee on Microbiological Criteria for Foods.
  • James Jones is President of JJones Environmental, following a 30-year career at the U.S. Environmental Protection Agency. His posts at EPA included five years as the Assistant Administrator, and his accomplishments include leading the agency’s effort to significantly reduce pesticides in food and navigating a years-long backlog of pesticide registrations and tolerances as well as leading the Obama Administration’s efforts to reform the Toxic Substances Control Act.
  • Barbara Kowalcyk, PhD, directs the Center for Foodborne Illness Research and Prevention at The Ohio State University’s College of Food, Agricultural, and Environmental Sciences and is Associate Professor of Food Safety and Public Health in the Department of Food Science and Technology. She is a well-respected epidemiologist and biostatistician, and a nearly ten-year member of the FDA Science Board, which she currently chairs.
  • Shiriki Kumanyika, PhD, MS, MPH, is Research Professor in the Department of Community Health and Prevention at Drexel University’s Dornsife School of Public Health. She has applied her interdisciplinary background and extensive research experience in numerous roles, and currently chairs the National Academies Food and Nutrition Board. She is also Emeritus Professor of Epidemiology at the Perelman School of Medicine, University of Pennsylvania.
  • John Taylor, JD, is President and Principal, Compliance and Regulatory Affairs, at Greenleaf Health. He spent more than 20 years at FDA, holding posts that included Counselor to the Commissioner, Acting Deputy Principal Commissioner, Acting Deputy Commissioner for Global Regulatory Operations and Policy, and Associate Commissioner for Regulatory Affairs.

The Independent Expert Panel will focus on structure/leadership, authority, resources, and culture as it develops recommendations to equip FDA to better carry out its regulatory responsibilities, strengthen its relationships with state and local governments, and secure the nation’s food supply for the future.