I must admit I was a bit suspect when I flew from Seattle to DC a few months ago to testify for 5 minutes before the Independent Expert Panel. Putting aside if they would pay attention to me, but would the panel take to heart the experience and thoughtfulness of all the panels and the panel members. From a read of the report, I think they did. Now the question is will Congress and the FDA Commissioner take the recommendations to heart?

Here are a few highlights cut from the final report:

Culture

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. 

Structure

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.

Structure changes should be implemented with cultural transformation efforts.

Honestly, this is what I focused on. I am convinced if you get the structure right and the right leaders in place, the culture will develop and the resources will be available. The Panel had five structural option. My preference is the first one:

Resources

The expectations of the FDA Human Foods Program and its impact on public health and our nation’s economy are immense. However, relatively modest increases in federal budget authority, flat staffing levels, and lack of sustained and sufficient commitment to upgrading information technology (IT)— contrasting with a rapidly changing food industry– have constricted the ability of the Human Foods Program to carry out its mission efficiently and effectively. In addition to aforementioned cultural and structural changes, the FDA’s Human Foods Program urgently needs additional personnel, financial, and IT resources to perform its Congressional mandate more effectively.

Here is the full report: https://www.marlerblog.com/files/2022/12/Human-Foods-Program-Independent-Expert-Panel-Final-Report-120622.pdf

The Independent Expert Panel, charged with generating the report by December 6th, 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.

I testified before the panel. It will be interesting to see the reccomendations.

Paige Cornwell Seattle Times staff reporter

Kirsten Paulsen began 2022 wanting to eat healthier and incorporate more vegetables into her diet. She found Daily Harvest, a food delivery company that touts easy to prep, plant-based meals, and signed up for regular shipments of smoothies, vegetable bowls and vegan ingredients to add to other dishes.

In one shipment, the Bellevue resident received a bag of French lentil and leek crumbles, for customers to add protein to a lasagna or an empanada. She prepared them according to the company’s instructions and added them to a meal. Within a day, she recalled, she was sweating profusely, dry heaving on the floor, in pain she equated to worse than giving birth to her son.

Her husband took her to an emergency room, where she was told she had heightened levels of bilirubin that could indicate potential issues with her liver or bile duct, and she was severely dehydrated. The doctors weren’t sure what caused the symptoms.

“The doctor asked me what I had eaten, because he thought I had been poisoned,” she said. 

Paulsen didn’t know at the time in June that others in the U.S., including at least 16 in Washington, had consumed the same Daily Harvest crumbles and reported feeling ill. 

In the months since their initial deliveries arrived, some of those Washington customers say they’re still sick, and a Seattle-area attorney is at the center of legal action related to the outbreak. 

After eating the crumbles from Daily Harvest, Paulsen said she was so sick that she collapsed on the floor of an emergency room bathroom. Her gallbladder was removed as a result of the illness and she has… (Daniel Kim / The Seattle Times)More 

Daily Harvest received 470 reports of “illness or adverse reactions,” the company wrote on its website in June. An estimated 133 people were hospitalized, according to the Food and Drug Administration, which received a total of 393 reports connected to the crumbles. 

Consumers reported gastrointestinal illnesses and abnormal functions of their livers, bile ducts, and/or gallbladders, according to the FDA. Some patients, including Paulsen, had their gallbladders removed.

Daily Harvest initiated a voluntary recall of the crumbles on June 17, sending an email that “a small number of customers have reported gastrointestinal discomfort” after consuming them. The company instructed customers to dispose of the crumbles, of which 28,000 units were distributed from April 28 to June 17 throughout the U.S. through online sales and delivery, at the Chicago Daily Harvest store and at a pop-up in Los Angeles. Samples were also sent to social media influencers, a detail that later played a unique role in connecting the people impacted by the outbreak.

“We are taking this very seriously and doing everything we can to get to the bottom of this. Your health and well-being are our top priority,” the company wrote five days later.

In July, Daily Harvest posted on its website that it had identified tara flour, a plant-based ingredient that’s high in protein, as the cause. The company launched an investigation, founder and CEO Rachel Drori wrote, and worked closely with the FDA, the Centers for Disease Control and Prevention, “as well as top doctors, microbiologists, toxicologists and three independent labs” to determine what caused the adverse effects. The crumbles were the first and only time tara flour was used by Daily Harvest, which has more than 140 items, Drori wrote. 

The FDA’s investigation is ongoing, the agency said last week, and it hasn’t determined the cause or ingredient that was the source of the reported symptoms.

Daily Harvest did not respond to The Seattle Times’ requests last week for additional on-the-record comments related to the lawsuits or allegations made in the lawsuits.

The company posted on its blog on Nov. 9 an extensive list of its food safety standards that have been in place since Daily Harvest was founded. This includes a requirement that farmers and suppliers confirm “every crop has been tested for toxins and pathogens.” They must show proof that food is organic, not genetically modified and allergen-free when applicable, Daily Harvestwrote. The company said it also conducts pesticide residue tests. 

The company previously said it would offer refunds to customers. For some who say they were sickened, a refund and possible answer to what made them sick wasn’t enough. A handful of lawsuits have been filed against the company, alleging Daily Harvest was negligent in oversight of its products and in adequately warning people about the crumbles. Daily Harvest has denied the allegations. 

Bill Marler, a food safety lawyer who is representing more than 300 people who were sickened by Daily Harvest’s lentil crumbles, is photographed at his Bainbridge Island office on Nov. 3, 2022. Marler was… (Daniel Kim / The Seattle Times)

Twolawsuits were filedby customers represented by Seattle-area lawyer Bill Marler, who says he’s been hired by 346 people across the U.S. who allege the crumbles made them sick. He withdrew a third complaint when he learned the company’s terms of use have an arbitration clause, meaning disputes must be solved through an arbitrator. Earlier this month, a federal judge in New York ruled another Daily Harvest customer’s lawsuit will go to arbitration. 

The lawsuits represented by Marler, one in state court and one in federal court, were filed on behalf of children he notes didn’t agree to the company’s terms of use. The federal complaint was filed by an Oklahoma man whose young daughter was allegedly sickened, and also lists manufacturer Stone Gate Foods and supplier Smirk’s. 

The claims, Daily Harvest said in an Oct. 28 court filing, fail in whole or in part because the company “did not know, nor should it have known of the alleged defect in the product,” nor did it create the alleged defect. An attorney representing Smirk’s said there was no evidence the tara flour correlates to the customers’ health issues and that the product met all specifications and food-importer requirements. Stone Gate Foods did not respond to requests for comment. 

Marler first heard about Daily Harvest from a former client he represented in the 1990s, who was infected due to an E. coli outbreak linked to undercooked beef at Jack in the Box restaurants. She was sickened again, Marler said, allegedly by the crumbles and received an email from Daily Harvest about the gastrointestinal complaints.

“She said ‘I am suffering more than just tummy aches. I’ve been really sick and on top of that, there are all these people on Reddit who have the same symptoms,’” he recalled.

Consumers learned about the outbreak not just from health departments but from Reddit, TikTok or Instagram. Influencers with hundreds of thousands of followers posted about their experiences; commenters wrote they had the same symptoms.

“The connection was made through social media,” Marler said. “That doesn’t happen very often.”

Anne Heartsong was recovering at home in Everett after three days in the hospital when she received a text from her niece telling her to check out a TikTok video. The June 18 video was from a popular TikTok creator who said about a month earlier she received the crumbles in a PR package from Daily Harvest and went to the ER with severe stomach cramps about a day after consuming them.

“My niece, who is in her 20s and into TikTok, said, ‘Auntie, you need to watch this TikTok,’” Heartsong said. “Every single one of the symptoms were mine. I am watching this video and my heart sinks. I thought ‘Oh my God, it’s Daily Harvest.’”

Heartsong ate the crumbles over a period of two weeks in June, until she started feeling ill; her body was shaking, her teeth were chattering and she developed a low fever. Her COVID-19 tests were negative, so she assumed she had contracted a bug from her three grandkids. Her symptoms worsened; her urine turned brown and her son-in-law, after a brief visit, called her daughter to say Heartsong was yellow. Heartsong had been too sick to notice her skin color change, she said.

She went to the Providence Regional Medical Center emergency department and was admitted with what the doctors told her was abnormal liver function. She underwent scores of tests; ultrasounds showed a normal gallbladder and bile ducts, according to medical records reviewed by The Seattle Times. Her paperwork listed “painless jaundice” as the first finding, though doctors didn’t note how or when her liver function became abnormal.

Her liver numbers returned to a normal range after two months, but she had severe fatigue for three months, forcing her to cancel a bike trip in Napa, California. She told clients at her commercial property and accounting business she was dealing with an unknown illness.

Paulsen, the Bellevue Daily Harvest customer, said she continues to suffer from gastrointestinal pain related to her gall bladder removal surgery. She can’t eat spicy or high-fat foods, or consume carbonated or caffeinated beverages. She’s lost 30 pounds. Last month, she was hospitalized again with severe stomach cramping. 

Kirsten Paulsen is photographed at her house at her house in Bellevue on Oct. 5, 2022. Paulsen had her gallbladder taken out after she ate Daily Harvest’s lentil crumbles, which have sickened hundreds… (Daniel Kim / The Seattle Times)

“My body was destroyed,” Paulsen said.

Heartsong initially subscribed to Daily Harvest for its convenience and to learn how to cook healthy, vegetarian meals. She canceled her subscription. Thanksgiving was the first time in months she ate some of her favorite foods again. But she’s still cautious.

“I’m a much safer eater now,” she said. “That’s for sure.”

I have been thinking it has been some time since I dug into a Naughty or Nice list. Here is one we at Food Safety News put together (with input from readers) in 2009. Reading these brings back a lot of memories, both good and bad. Shoot me an email at bmarler@marlerclark.com with your thoughts on who should be on this year’s list.

After much thought and consideration, here was the Food Safety News Naughty list for 2009:

NAUGHTY:  Stewart Parnell, President of Peanut Corporation of America, for asking for nearly $1 million from his bankrupt business for his own criminal defense fund after shipping peanuts his own tests showed were contaminated with Salmonella that sickened over 700 and killed at least nine. (See “PCA Executives To Divide $875,000,” Dec 11, 2009)

NAUGHTY:  President Obama for NOT appointing a new permanent U.S. Department of Agriculture Under Secretary for Food Safety. ALSO NAUGHTY: USDA Secretary Tom Vilsack for making excuses about it.  (See “FSIS Remains Leaderless,” Oct. 16, 2009) 

NAUGHTY:  Some raw milk, small and sustainable agriculture advocates who confused the entire food safety debate by making and circulating false claims about the bills.  It really is about food safety and is not a gigantic conspiracy by Monsanto to wipe out organic and backyard farms!   

NAUGHTY:  FDA’s Office of Criminal Investigations and the U.S. District Attorney in Georgia for moving so slowly with the criminal investigations of the Peanut Corporation of America and its executives, including Stewart Parnell. (See “One Year Later, Still no Charges for PCA,” Nov 07, 2009)

NAUGHTY:  President Obama and Vice-President Biden for ordering undercooked hamburgers for the Press Corps at a DC restaurant with less than stellar inspection reports.

NAUGHTY:  Washington State University for removing Michael Pollan’s “Omnivore’s Dilemma” from the Common Reading Program.

NAUGHTY:  The FDA for caving to political pressure and backing down on oyster regulations.  (See “Under Pressure, FDA Puts Oyster Policy On Hold,” Nov 14, 2009) 

NAUGHTY:  The Senate for being too slow on health care reform to pass meaningful–and decades overdue–food safety legislation before the Holidays.

NAUGHTY:  Weston A. Price Foundation for more denial of outbreaks and giving consumers false information about raw milk safety.

NAUGHTY:  FDA for its failure to control ridiculous health claims like Kellogg’s claiming that Cocoa Krispies are a “Smart Choice” because it “helps support your child’s immunity.”  (See “Do Krispies Boost Kids’ Immune Systems?” Nov 01, 2009) 

NAUGHTY:  J. Patrick Boyle of the American Meat Institute for trying to dynamite the Senate food safety bill even though it doesn’t have anything to do with the meat industry.  

NAUGHTY:  State public health department officials attending the Interstate Shellfish Sanitation Conference in October who put industry profits ahead of public health. 

NAUGHTY:  Rep. Charlie Melancon for declaring the death of 15 people a year is not too high a price to pay for a U.S. Senate seat in an oyster growing State. (See “Under Pressure, FDA Puts Oyster Policy On Hold,” Nov 14, 2009) 

NAUGHTY:  Secretary Vilsack and White House for trying, in the name of free trade, to roll over Rep. Rosa DeLauro’s efforts to assure that the US does not permit poultry processors from shipping raw poultry meat from the US to China for processing and shipping back to the US for sale until USDA has determined that China’s inspection program is equivalent to ours. (See “Deal Reached on Poultry Imports,” Sep 27, 2009)  

NAUGHTY:  FDA Commissioner Margaret Hamburg for urging Congress to give the Agency authority to reduce the intensity of inspections if they don’t get all the money they ask for.

NAUGHTY:  The FDA staff that keeps appealing to consumer advocates, “don’t set us up to fail,” when consumer advocates push for more inspection.  They never say, “help us get the law and resources we need to protect people.” 

After much thought and consideration, here was the Food Safety News Nice list for 2009:

NICE: Sen. Dick Durbin for being the driving force behind food safety legislation in the Senate and the HELP Committee for passing S. 510 out of committee with bipartisan support. (See “Senate Schedules Markup of S. 510,” Nov 11, 2009)

NICE: Rep. Rosa DeLauro and Sen. Kirsten Gillibrand for being consumer champions and persistent advocates of food safety reform. (See “DeLauro Urges Inquiry Into Beef Testing,” Nov 13, 2009, “DeLauro Calls for Beef Plant Closure,” Dec 10, 2009 and “Gillibrand to Introduce ‘E.coli Eradication’ Bill,” Oct 14, 2009) 

NICE:  Food & Drug Administration Commissioner Margaret Hamburg for improving public access to information, including “Warning Letters” and 483 Reports.  (See “FDA Expands What’s In ‘Warning Letters,’” Sep 17, 2009) 

NICE: Secretary Vilsack and Deputy Secretary Kathleen Merrigan for USDA’s new outreach programs, like “Know your farmer, know your food.”  (See “USDA Promotes Local Food,” Sep 25, 2009)

NICE: New York Times writer Michael Moss for his Pulitzer-worthy article on the dark origins of ground beef and the terrible impact of E. coli O157:H7. 

NICE: The quick work of the U.S. House Energy and Commerce Committee, whose members worked quickly and got their hands on incriminating email traffic between the PCA executives, who took the Fifth Amendment when called to testify.  

NICE:  President Obama for setting up the Food Safety Working Group.

NICE: The public, for an outpouring of support for WSU’s Common Reading Program (hat tip, Food Democracy Now). 

NICE: Makers of Food, Inc, who introduced the country to the underside of food production, and made a very watchable – if frightening – film about it.

NICE: Michelle Obama, for planting a kitchen garden at the White House, and getting kids involved in (very) local food and for getting a local DC farmer’s market through the red tape.

NICE:  FDA for getting a guilty plea by Mark McAfee of OPDC to criminal charges of misbranding raw milk and selling across state lines as “pet food.”  (See “FDA Attempts to Corral Raw Milk Producer,” Dec 17, 2009) 

NICE:  Marion Nestle for, among other things, her persistent and common sense critique of how junk food and soda is marketed to children.  (See “Q&A: Nestle on Food Safety Politics,” Sep 21, 2009) 

NICE: Mike Taylor and Don Kraemer at FDA for boldly putting public health ahead of Gulf Coast oyster industry profits.  (See “FDA Acts to Reduce Raw Oyster Poisoning,” Oct 20, 2009) 

NICE:  Consumer and public health groups that have joined with produce growers and food processors and retailers to support FDA reform legislation, making its passage possible.  (See “Victims: ‘We Want Bill Before Holidays’,” Oct 08, 2009)

NICE: Dedicated writers whose excellent articles gave insight and context to food safety issues:  Lyndsey Layton of the Washington Post for her piece on Linda Rivera’s struggle with E. coli O157:H7 from cookie dough, Peter Eisler, Elizabeth Weise, and others of USA Today for their reporting on school lunches, and Nick Grube of the Daily Triplicate for his three-part series on Mari Tardiff’s struggle to recover from the Campylobacter infection and ensuing Guillain-Barre Syndrome she got from drinking raw milk.

NICE:  Food Bloggers – Simple, Good and Tasty, Cold Truth, Ag and Food Law, Civil Eats, Grist, Weaversway, Chuck Jolley, Food Politics, Ethicurean, La Vida Locavore, Obamafoodorama, Food Shield, efoodalert, Fanatic Cook, Fresh Talk, Center for a Liveable Future, Food Law, Buy Safe Eat Well and Barf Blog.

NICE: Bill Marler and Marler Clark, LLP for their generous support of all three Food Safety News offices in Seattle, Denver, and Washington, DC to make FSN’s coverage of important food safety issues possible, even as traditional media shrink.

These lists were a compilation of submissions from the Food Safety News publisher, staff, readers, and food safety experts.