The Food and Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply 

Prior Office of Inspector General (OIG) reviews focused on U.S. Food and Drug Administration (FDA) oversight of food recalls. Food recalls are the most effective means of protecting public health when a widely consumed food product is either defective or potentially harmful. At the time of those OIG reviews, FDA did not have statutory authority to require food manufacturers to initiate recalls of most foods.

After those reviews, enactment of the FDA Food Safety Modernization Act gave FDA new authority to order a mandatory recall and require firms to recall certain harmful foods. We conducted this review to determine whether FDA is fulfilling its responsibility in safeguarding the Nation’s food supply now that it has mandatory recall authority.

Our objective was to determine whether FDA had an efficient and effective food-recall process that ensured the safety of the Nation’s food supply. Specifically, we focused on FDA’s (1) oversight of firms’ initiation of food recalls, (2) monitoring of firm-initiated recalls, and (3) maintenance of food-recall data in the electronic recall data system.

We reviewed documentation for 30 voluntary food recalls judgmentally selected from the 1,557 food recalls reported to FDA between October 1, 2012, and May 4, 2015.

FDA did not always have an efficient and effective food-recall process that ensured the safety of the Nation’s food supply. We identified deficiencies in FDA’s oversight of recall initiation, monitoring of recalls, and the recall information captured and maintained in FDA’s electronic recall data system, the Recall Enterprise System (RES). Specifically, we found that FDA could not always ensure that firms initiated recalls promptly and that FDA did not always (1) evaluate health hazards in a timely manner, (2) issue audit check assignments at the appropriate level, (3) complete audit checks in accordance with its procedures, (4) collect timely and complete status reports from firms that have issued recalls, (5) track key recall data in the RES, and (6) maintain accurate recall data in the RES.

Recalls were not always initiated promptly because FDA does not have adequate procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls. FDA’s monitoring of recalls was not always adequate because FDA staff had insufficient oversight to ensure that the assignment was at the appropriate level, and FDA obtained incomplete or inaccurate consignee information from firms initiating recalls. Additionally, FDA lacked adequate procedures to collect timely and complete status reports from these firms because the procedures did not require staff to request status reports at the time the recall was initiated. Lastly, the RES contained deficient recall information because it did not track all information necessary for FDA to effectively monitor recall activities and assess the timeliness of recalls; the RES also contained inaccurate data.

We recommended that FDA use its Strategic Coordinated Oversight of Recall Execution (SCORE) initiative to establish set timeframes, expedite decision-making and move recall cases forward, and improve electronic recall data. We also made other procedural recommendations, which are listed in the report.

FDA agreed with our conclusion that it needs to help ensure that recalls are initiated promptly in all circumstances and said that it will consider the results of our review as it “continues to operate the SCORE team.” FDA also described other actions it has taken in response to our early alert, issued June 8, 2016, and draft report including initiating a new quality system audit process and a plan to provide early notice to the public and more guidance to staff.

Download the complete report or the Report in Brief.

Public Health England has linked a 12 cases of E. coli to Sainsbury’s Taste the Difference Aberdeen Angus quarter-pounder burgers, 454g packets, which are sold in the frozen section. Product: Taste the Difference 4 pack Aberdeen Angus British Beef Quarter Pounders (Frozen). Batches with ‘Best Before’ dates: July 2018, September 2018 and October 2018

The Public Health Agency of Canada says 40 E. coli illnesses are under investigation as possibly being linked to romaine lettuce. People who have reported illnesses have said that they ate romaine at home, at restaurants and in prepared salads purchased from grocery stores. The people infected are between the ages of 4 to 80 years of age and 70 % are women. One person has died.

The Centers for Disease Control and Prevention and the Kansas Department of Health and Environment have linked one person’s Salmonella Oranienburg infection to taking rattlesnake pills. Rattlesnake pills are often marketed as remedies for various conditions, such as cancer and HIV infection. These pills contain dehydrated rattlesnake meat ground into a powder and put into pill form. CDC recommends that you talk to your health care provider if you are considering taking rattlesnake pills, especially if you are in a group more likely to get a severe Salmonella infection.

Epidemiologic and laboratory evidence indicate that one person in Kansas became sick after taking rattlesnake pills purchased in Mexico. The ill person reported taking rattlesnake pills in the week before getting sick. Advanced laboratory testing called whole genome sequencing showed that the Salmonella that made the person sick matched the Salmonella found in rattlesnake pills from Mexico collected in an earlier, unrelated investigation.

Reptiles and their meat can carry Salmonella and make people sick. Past outbreak investigations have identified rattlesnake pills as a source of human Salmonella infections.

People in the following groups are more likely to get a severe Salmonella infection: People with weakened immune systems, including people who are receiving chemotherapy or have HIV; pregnant women; children younger than 5 years; and older adults. If you get sick after taking rattlesnake pills, contact your health care provider.

The Rhode Island Department of Health (RIDOH) said Arruda’s Dairy Farms of Tiverton is recalling its pint, quart and half-gallon clear containers of eggnog.

The affected products have a sell-by date of 2/3/18 or 2/10/18 and were distributed to retail stores and home-delivery customers throughout eastern Rhode Island and the Fall River area, health officials said.

No illnesses have been reported in connection with the recall, according to RIDOH, and the production of the eggnog has been halted until the problem is resolved.

The issue was identified after RIDOH conducted product sampling and found the presence of Salmonella bacteria, which can cause serious, sometimes fatal infections in young children and frail or elderly people, according to the Food and Drug Administration.

The Interagency Food Safety Analytics Collaboration (IFSAC) published its analysis of what food tend to be linked to certain bacteria.

Salmonella illnesses came from a wide variety of foods. Salmonella illnesses were broadly attributed across multiple food categories. More than 75% of Salmonella illnesses were attributed to seven food categories: Seeded Vegetables (such as tomatoes), Eggs, Chicken, Other Produce (such as nuts), Pork, Beef, and Fruits.

E. coli O157 illnesses were most often linked to Vegetable Row Crops (such as leafy greens) and Beef. More than 75% of illnesses were linked to these two categories.

Listeria monocytogenes illnesses were most often linked to Fruits and Dairy products. More than 75% of illnesses were attributed to these two categories, but the rarity of Listeria monocytogenes outbreaks makes these estimates less reliable than those for other pathogens.

Non-Dairy Campylobacter illnesses were most often linked to Chicken. Almost 80% of non-Dairy foodborne illnesses were attributed to Chicken, Other Seafood (such as shellfish), Seeded Vegetables, Vegetable Row Crops, and Other Meat/Poultry (such as lamb or duck). An attribution percentage for Dairy is not included because, among other reasons, most foodborne Campylobacter outbreaks were associated with unpasteurized milk, which is not widely consumed, and we think these over-represent Dairy as a source of Campylobacter illness. Removing Dairy illnesses from the calculations highlights important sources of illness from widely consumed foods, such as Chicken.

Here is the full report.

The U.S. Food and Drug Administration has issued an Import Alert over hepatitis A found in raw, frozen tuna from Sustainable Seafood Co. Ltd. in Can Lam, Vietnam, and P.T. Deho Canning Company in North Sulawesi, Indonesia.

“FDA believes that hepatitis A virus-contaminated seafood is a result of insanitary conditions in the production or packing facilities, e.g., poor worker hygiene, inadequate worker sanitation facilities, and/or contaminated water supply,” FDA said in the alert.

The FDA found hepatitis A virus in frozen raw tuna samples from the two suppliers in May 2017, but is issuing the Import Alert now “to address seafood products being introduced for entry based on two recent outbreaks,” Jason Stratchman-Miller, a spokesperson for FDA, told SeafoodSource.

In May, Hilo Fish Company in Hawaii recalled tuna sourced from Sustainable Seafood Company and Santa Cruz Seafood, Inc. that tested positive for the hepatitis A virus. The tuna had been distributed to several U.S. grocery stores.

“The current recall resulted from follow-up after the Hawaii Department of Health notified the FDA of a frozen tuna sample, sourced from PT Deho Canning Co., which tested positive for hepatitis A on 1 May, 2017,” FDA said in a statement in May.

In the new Import Alert, FDA explained that hepatitis A virus is excreted in feces of infected people “and can produce clinical disease when susceptible individuals consume contaminated water or foods.” 

As a result of the alert, FDA “may detain, without physical examination, shipments of fresh or frozen raw seafood” from Sustainable Seafood Co. and P.T. Deho Canning Company, the regulator said.

“Hepatitis A virus is primarily transmitted by person-to-person contact through fecal contamination, but common-source epidemics from contaminated food and water also occur,” FDA said in the alert. “Poor sanitation and crowding facilitate transmission. Contamination of foods by infected workers in food production facilities/processing plants and restaurants is common.”

So, where did the romaine lettuce come from?

The Public Health Agency of Canada is collaborating with provincial public health partners, the Canadian Food Inspection Agency and Health Canada to investigate an outbreak of Escherichia coli O157:H7. The outbreak involves five provinces and is linked to romaine lettuce. At this time, there are no product recalls associated with this outbreak. The outbreak investigation is ongoing, and this public health notice will be updated on a regular basis as the investigation evolves

Currently, there are 30 cases of E. coli O157 illness under investigation in five provinces: Ontario, (6), Quebec (5), New Brunswick (5), Nova Scotia (1), and Newfoundland and Labrador (13). Individuals became sick in November and December 2017. Twelve individuals have been hospitalized. One individual has died. Individuals who became ill are between the ages of 4 and 80 years of age. The majority of cases (70%) are female.

So, where did the romaine lettuce come from?

Jim Sinnema, owner of Old Silvana Creamery, issued a recall today for the milk because samples of it have tested positive for E. coli.  The milk has best-by dates between Dec. 15 and Dec. 23.

“The recall includes both of the firm’s retail raw milk brands, ‘Jim’s Jerseys’ and ‘Guernsey Goodness,’ which were bottled in half-gallon and one-gallon plastic jugs with orange or green caps. Recalled product was sold at the on-farm store, directly to private customers, and at retail stores in Western Washington,” according to the recall notice.

“Consumers who have purchased Old Silvana Creamery retail raw milk with ‘Best By dates’ of  12/15 through 12/23 are urged not to drink the product and return it to the place of purchase for a full refund. Consumers with questions may contact the company at 425-268-7961.”

Anyone who has consumed any of the recalled milk and developed symptoms of E. coli infection should immediately seek medical attention and tell their doctors about the possible exposure. Specific tests are required to diagnose E. coli infections. No illnesses had been reported as of today, according to a spokesman with the Washington State Department of Agriculture (WSDA).

However, it can take up to 10 days for symptoms of E. coli infection to develop. Consequently, anyone who has consumed the recalled raw milk or served it to their children or others should watch for symptoms in the coming days.

Symptoms often begin slowly with mild belly pain or non-bloody diarrhea that worsens over several days, according to the Centers for Disease Control and Prevention. Other symptoms can include severe stomach cramps, bloody diarrhea, and vomiting. If there is fever, it usually is not very high, less than 101 degrees F.

A life-threatening complication — hemolytic uremic syndrome (HUS) — impacting the kidneys can occur, especially in children. It develops an average of seven days after the first symptoms appear, often when the diarrhea is improving.

This is at least the third time Old Silvana Creamery has recalled its raw milk because of contamination issues. In January 2015 the dairy recalled unpasteurized milk when Campylobacter bacteria were detected. In 2013 the dairy recalled raw milk because of antibiotic residues, according to records at WSDA.

“Old Silvana Creamery LLC and WSDA continue to work jointly to address the source of the problem while conducting additional product testing through the WSDA laboratory as well as Old Silvana Creamery’s independent laboratory,” according to the dairy’s recall notice.

It is within the law to sell unpasteurized milk and other dairy products at retail locations, according to Washington state law, but state health officials caution that it carries significant risks, especially for young children, the elderly, pregnant and nursing women and anyone with a suppressed immune system, such as cancer patients.

State law requires unpasteurized, raw milk and raw dairy products to carry warning labels.

The Public Health Agency of Canada is collaborating with provincial public health partners, the Canadian Food Inspection Agency and Health Canada to investigate an outbreak of Escherichia coli O157, commonly called E. coli. The outbreak involves three provinces and is linked to romaine lettuce. At this time, there are no product recalls associated with this outbreak. The outbreak investigation is ongoing, and this public health notice will be updated on a regular basis as the investigation evolves.

Currently, there are 21 cases of E. coli O157 illness under investigation in three provinces: Quebec (3), New Brunswick (5), and Newfoundland and Labrador (13). Individuals became sick in November 2017. Ten individuals have been hospitalized. No deaths have been reported. Individuals who became ill are between the ages of 5 and 72 years of age. The majority of cases (71%) are female.

Many individuals who became sick reported eating romaine lettuce before their illnesses occurred. The Canadian Food Inspection Agency is working with public health officials to determine the source of the romaine lettuce that ill individuals were exposed to.