The OIG has been investigating the FDA’s recall procedures and on Wednesday, according to Food Safety News, gave the agency a “heads up” that left little to the imagination that changes need to be made in policies and procedures governing food safety
Specifically, the OIG is focusing on the fact that in too many cases, the American public has been put at risk of pathogenic diseases because the FDA was slow in issuing recall notices because the “FDA did not have policies and procedures to ensure that firms or responsible parties initiated voluntary food recalls promptly. This issue is a significant matter and requires FDA’s immediate attention,” according to OIG’s early alert.
The alert goes on to say, “We suggest that FDA updates its policies and procedures to instruct its recall staff to establish set time-frames for: 1. FDA to request that firms voluntarily recall their products and 2. firms to initiate voluntary food recalls.”
Keep in mind that the USDA, FSIS and FDA are using the latest technology available to track and follow production and manufacturing, from the federal, state and local company level. We know where the food comes from, or at least the government does, plus these agencies have inspection personnel on the ground in the various states, working alongside state and local health officials.
Even more important is the identification of pathogens responsible for food-borne outbreaks. The Centers for Disease Control and Prevention (CDC) uses PulseNet, a nationwide database of pathogenic bacterial DNA fingerprints, used to track and identify pathogens in linked to outbreaks using pulsed-field gel electrophoresis (PFGE) and whole genome sequencing (WGS).
So it leaves me clueless. Why is it taking so long for a recall to be initiated, and why in the world, after a pathogen has been identified, does it take so long for a company to fully correct violations that caused the outbreak in the first place?
How long does it take to ask a company to issue a recall of a product?
The OIG staff looked at over 30 recalls dating from October 2012 to May 2015. Two specific recalls were mentioned in detail and included a nut butter recall from nSpired Natural Foods, Inc. for Salmonella contamination that wasn’t initiated until 165 days after (almost six months) the FDA had identified the adulterated product. In this recall, 14 people were sickened.
The other case cited involved a series of recalls involving various cheese products where at least nine people became ill from Listeria monocytogenes, including one infant who died. The CDC also was able to link two fetal deaths to the products in this case. It took the FDA 81 days from the point they became aware of the adulterated product until the firm, Oasis Brands, Inc., issued a voluntary recall.
I am going to add another case everyone is familiar with — Dole packaged salads. The CDC investigated the outbreak organism, Listeria monocytogenes in specimens that dated back to July 2015. Yet Dole didn’t issue a recall until January 21, 2016. By that time, 19 people in the U.S. and six people in Canada had been sickened. One person died.
The CRF Frozen Foods fiasco
On Friday, Food Safety News revealed that state and federal agencies have known about the series of violations at CRF Frozen Foods of Pasco, Washington. This frozen food firm is linked to the Listeria outbreak that has been going on since May 2014. What blows me away is the fact that the plant is still in operation, despite the violations.
CRF Foods didn’t issue a voluntary recall until April 23, 2016, and by then, a number of people had been sickened and two people had died. This outbreak is still being investigated, and the company’s products are being distributed to schools under the Department of Agriculture’s school lunch program, nursing homes. and other facilities and retailers.
The list of violations documented by inspectors from the Washington State Department of Agriculture (WSDA) and FDA, beginning in December 2014 and continuing through March of this year, included:
1. broken and cracked floors;
2. dirt, trash and food debris;
3. leaking pipes;
4. mold-like residues;
5. inoperable hand-washing stations;
6. multiple examples of broken and worn equipment and surfaces that were impossible to clean and sanitize;
7. external doors left open, allowing possible entry of rodents and other pests, and,
8. bathroom doors leading into a processing room left open, possibly exposing food to airborne pathogens.
The FDA posted some of the violation letters this week on their site. In one letter, FDA inspectors discuss the finding of dead rodents in some of their packages of frozen vegetables.
During the most recent inspection in March of this year, Camp and CRF president Jonathan Rodacy refused to provide inspectors with any company records, saying all documents were proprietary information. They also refused to allow inspectors to take photographs, according to FDA’s inspection report. Yet the FDA is allowing this company to continue to operate? Get real!
Here’s the clincher, folks. Many of the violations discovered in a December 2014 inspection by the FDA were still present in 2015 inspections and still there in March 2016. Yet the company still is putting out food for us to eat. So does the FDA really protect the American consumer? To me, it is questionable right now. Why hasn’t CRF Frozen Foods been closed down, and even more to the point, how many other food processors are out there with similar food safety violations?
