Abbott’s senior vice president grilled by members of House subcommittee

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

“We know we let you down.”

The senior vice president of Abbott Nutrition — the manufacturer of infant formula whose plant closure amid a food safety investigation has left the country in dire straits with parents scrambling to find food for their babies — opened his testimony before a U.S. House panel Wednesday with that admission of guilt.

The day-long hearing before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce was billed as an investigation into the infant formula shortage and the reasons behind it.

During the first half of the hearing members of the U.S. House of Representatives grilled top administrators from the Food and Drug Administration about the shortage and the agency’s investigation into Abbott’s Sturgis, MI, manufacturing plant. FDA Commissioner Robert Califf told the panel that the agency could have done a better job managing its investigation. (See our related story for complete coverage.)

The second half of the day was reserved for three executives from the baby food industry with about half of the time devoted to the shortage and the other half focusing solely on Abbott’s food safety status.

Abbott was represented by its senior vice president Christopher Calamari. Two other infant formula manufacturers also had top executives on hand to answer questions: Scott Fitz, vice president of Gerber, and Robert Cleveland, senior vice president of Reckitt. Together the three companies represent about 90 percent of the infant formula market in the United States. Abbott alone has 40 percent of the market.

Members of the House subcommittee questioned all three men about the status of infant formula production with little in the way of solutions offered for resolving the current shortage. All of the companies are working to meet the need with ramped-up production at U.S. plants. They are also working with the federal government to increase imports of infant formula.

As pressing as the need for more infant formula is, the reason behind the shortage received as much time in the spotlight as the shortage itself. If Abbott had not had to close down its Sturgis, MI, plant because of food safety issues there would not be a shortage.

Calamari repeatedly told the House subcommittee that Abbott is doing everything possible to get its plant up and running. It was closed down in mid-February when the company initiated a massive recall. The recall came amid an FDA investigation into links to a cronobacter outbreak that saw at least four babies hospitalized. Two of them died.

Time after time Calamari said that Abbott is “taking steps” to resolve food safety problems and make sure they don’t reoccur. Time after time the House members asked what the company is doing.

When Committee Chair Rep. Diana DeGette, D-CO, asked the question Calamari gave his generalized answer. DeGettee called him on it, seeking more specifics. The Abbott senior vice president then ticked off a handful of actions including replacing floors, repairing the roof, and changing the way personnel move through the 700,000-square-foot manufacturing plant.

During her closing remarks, the subcommittee chair remarked on the bipartisan outrage about the situation at the Abbott plant. She told Calamari that his answers had been “too vague.”

Highlights from other subcommittee members’ questions about the food safety situation and the answers from Calamari follow.

Rep. H. Morgan Griffith, R-VA
The ranking member of the subcommittee told Calamari that Abbott has more than a problem with its roof and floors. He cited a whistleblower document that reported managers hiding information from top corporate management and said the company has a “culture problem” and asked, “have any heads rolled?”

Calamari responded by saying he didn’t think it was a culture problem and that just last week he visited the Sturgis, MI, plant and met with multiple generations of employees there who are committed to producing safe infant formula.

Rep. Cathy McMorris Rodgers, R-WA
When the representative asked why there were cronobacter bacteria in the production facility Calamari said “it wasn’t in the production area,” adding that it is a naturally occurring bacteria. McMorris Rodgers asked Calamari what Abbott is doing to make sure its food safety issues do not recur he said the company “is committed to preventing future problems.”

Rep. Michael C. Burgess, R-TX
Burgess wanted to know when Abbott management was made aware of the whistleblower document. Calamari said they didn’t know about it until it was made public by Congress in April. He also said he did not want to speak to points made in the document because it is the subject of an ongoing investigation.

Rep. Kathleen M. Rice, D-NY
Rice also asked Calamari about the whistleblower document, wanting to know what measures Abbott has in place for employees to raise food safety concerns. Calamari said there is an “independent” entity within the company that takes and reviews employee concerns and that it was the whistleblower’s choice to not use the system to report concerns. Rice also asked what the company plans to do to make sure employees feel comfortable reporting issues and Calamari said the company would “encourage them to speak up.”

Rep. Janice D. Schakowsky, D-IL
Telling Calamari that she is “livid” about the situation and that the inspection report about the Sturgis, MI, plant is “disgusting,” Schakowsky asked him if he would take personal responsibility; he said “yes.”

Rep. Gary J. Palmer, R-AL
Calamari told Palmer that he was not aware of problems at the plant until FDA inspected it earlier this year. When Palmer asked why problems had not been addressed earlier Calamari said the company is committed to safety.

Rep. Scott H. Peters, D-CA
Peters asked how much of Abbott’s resources go toward food safety and Calamari said “tens of millions of dollars.” Peters then asked if it should be more. Calamari said, “we are committed to doing what it takes.”

Rep. Kim Schrier, D-WA
Schrier wanted to know why Congress should trust Abbott to fix problems at the production plant, especially in light of the whistleblower accusations of falsified records. Calamari said, “we are aligned with the FDA” on plans to reopen the plant.

Learn more about Cronobacter sakazakii and other foodborne disease outbreaks in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.

TAINTED formats 3 — “Reads like a true crime novel” – Food Safety News

Jif’s Salmonella outbreak. What we know so far

The US Centers for Disease Control and Prevention (CDC) is investigating an outbreak of Salmonella Senftenberg infections believed to be linked to consumption of Jif peanut butter products.

Jif peanut butters are manufactured by The JM Smucker Co.

outbreak-salmonella-peanut-butter-cdc-case-count-map The fourteen confirmed cases are scattered across twelve US states, including Arkansas (1), Georgia (2), Illinois (1), Massachusetts (1), Missouri (1), New York (1), North Carolina (1), Ohio (1), South Carolina (1), Texas (2), Virginia (1), and Washington (1). Two of the victims have been hospitalized.

The first reported victim became ill on February 17, 2022.

Outbreak victims range in age from less than one year old to 85 years old. The median age is 56, and 71% of the victims are female.

Interviews conducted with five of the outbreak victims revealed that all five had consumed peanut butter prior to falling ill. Two of the five had eaten Jif Creamy Reduced Fat peanut butter, one person reported Jif Natural Creamy Low Sodium peanut butter, and one person reported Jif Natural Creamy peanut butter.

The CDC cautions that the true number of sick people in an outbreak such as this is likely much higher than the number reported, and the outbreak may not be limited to the states with known illnesses.

According to the US Food and Drug Administration (FDA), the outbreak strain is closely related to a strain of Salmonella recovered in 2010 from an environmental sample in the Lexington, Kentucky, manufacturing plant where the implicated Jif peanut butter products are made.

A review of the FDA’s inspection database reveals that the Lexington facility was inspected on five separate occasions since 2009, including inspections in 2009, 2010, 2011, 2015, and 2018.

The 2010 and 2015 inspections were classified as Voluntary Action Indicated (VAI), meaning the inspector found deficiencies that needed to be corrected by the company. There is no list of the reported deficiencies in the database for either of the VAI inspections.

Recall status

The JM Smucker Co. has recalled a long list of Jif products, covering all lot codes from 1274425 to 2140425, but only with the first seven digits ending in 425 (the identifier code for the Lexington production plant).

Recalled products were distributed across the United States and exported to Canada.

The company has issued a separate recall notice listing the products distributed in Canada.

In addition to being sold through retail stores and other outlets, peanut butter is often used as an ingredient in other products. Recalls of products containing Jif peanut butter have already begun.

For an up-to-date linked list of announced recall notices, please select the Jif/Smucker Recalls menu item at the top of the page.

CDC’s advice to consumers

Do not eat any recalled Jif brand peanut butter. Throw it away.
This product has a very long shelf life, so be sure to check any Jif peanut butter you have at home to make sure it has not been recalled.
Wash surfaces and containers that may have touched the recalled peanut butter using hot, soapy water.
Call your healthcare provider if you have one or more of these symptoms after eating recalled peanut butter:
- Diarrhea and a fever higher than 102°F
- Diarrhea for more than 3 days that is not improving
- Bloody diarrhea
- So much vomiting that you cannot keep liquids down
- Signs of dehydration, such as:
  - Not peeing much
  - Dry mouth and throat
  - Feeling dizzy when standing up

CDC’s advice to businesses

Do not sell or serve recalled Jif brand peanut butter.
Wash and sanitize containers and surfaces that may have come in contact with recalled peanut butter.

Read more about previous outbreaks of Salmonella involving peanut butter in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.

Salmonella outbreak linked to Jif peanut butter products

The FDA, together with the CDC and state and local partners are investigating an outbreak of fourteen (14) Salmonella Senftenberg infections in twelve US states.

Two people have been hospitalized.

Cases have been reported in Arkansas (1), Georgia (2), Illinois (1), Massachusetts (1), Missouri (1), Ohio (1), North Carolina (1), New York (1), South Carolina (1), Texas (2), Virginia (1), and Washington (1).

According to the FDA, five out of five outbreak victims who were interviewed reported consuming peanut butter prior to becoming ill. Four of the five specifically mentioned Jif peanut butter.

Although the FDA has not yet found the outbreak strain in a finished product sample, the agency reports that a strain of Salmonella recovered from an environmental sample collected at the Jif Lexington, Kentucky, production plant twelve years ago (in 2010) is a genetic match for the Salmonella strain recovered from victims in this current outbreak.

This archival culture, combined with the information from outbreak victims who had consumed Jif peanut butter, catalyzed a voluntary recall on the part of The J.M. Smucker Co., the manufacturer of the Jif family of products.

The recall

The recall includes lot codes from 1274425 to 2140425, but only for lot codes that end in “425,” which is the identifier code for the Lexington, Kentucky production plant. Recalled products were distributed nationwide in the United States.

For a complete list of affected products, please refer to the J.M. Smucker recall notice.

As the recalled products have a two-year shelf life, the FDA urges consumers to check their pantries and discard or return any of the products included in the recall.

The lot code can be found near the bottom of the product label, directly below the BEST IF USED BY date, as illustrated here.

FDA recommends:

Consumers, restaurants, and retailers should not eat, sell, or serve any recalled Jif brand peanut butter that have lot code numbers 1274425 through 2140425. This product has a two-year shelf life so consumers should check any Jif peanut butter in their home.
If you have used the recalled Jif brand peanut butter that have lot code numbers 1274425 through 2140425, you should wash and sanitize surfaces and utensils that could have touched the peanut butter.
If you or someone in your household ate this peanut butter and have symptoms of salmonellosis, please contact your healthcare provider.

Read more about Salmonella in peanut butter in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.