FDA and Stealth Recalls

Stealth – the act or characteristic of moving with extreme care and quietness, especially so as to avoid detection

– Collins English Dictionary – Complete and Unabridged © HarperCollins Publishers 1991, 1994, 1998, 2000, 2003

About 10 days ago, I complained about an unpublicized Class I recall, which was described in FDA’s Weekly Enforcement Report dated February 8, 2012. The recall involved 114 tons of cut leaf “curly” spinach from Tiro Tres Farms, Eagle Pass, TX. The offending spinach was recalled by the manufacturer after the product was found to be contaminated with E. coli O157:H7.

I received some comments – and some flak – about my article, so I decided to see whether this was a one-time incident or whether there have been other Class I recalls about which we consumers were never informed. The following recalls were gleaned from FDA Weekly Enforcement Reports dated on or after November 2, 2011.

  • Nicho Produce Co., Inc. (Edinburg, TX): A CUT ABOVE produce items. Thirty-three (33) different items, including shredded, cut, sliced, diced or cubed salad greens, vegetables and fruits, most of them packed in 5-lb bags. Products were recalled due to potential contamination with Listeria monocytogenes. This was an FDA-initiated Class I recall, announced by letters dated December 9th and 19th, 2011, and involved 9,829.5 “pieces” distributed in Texas.
  • River Ranch Fresh Foods LLC, (Salinas, CA): River Ranch and Hy-Vee bagged salads and coleslaw with Best if Used by date of 4 NOV 2011. Product was recalled after FDA found two environmental sub samples positive for Listeria monocytogenes. This was an FDA-initiated Class I recall that was subsequent to an earlier public recall of Farmers Market and Hy-Vee brands of bagged salads, also produced by River Ranch. This stealth recall involved 588 cases of bagged salads, which were distributed to Indiana, Iowa and Canada.
  • Rio Queen Citrus, Inc. (Mission, TX): TexRio Tomatoes, packed in 20-lb bulk boxes, imported from Mexico. Notification of the company-initiated Class I recall was by telephone on November 25, 2011. Two hundred forty-three (243) boxes were recalled because the tomatoes were potentially contaminated with Salmonella. Distributed to Texas and Missouri.
  • Four Seasons Produce, Inc. (Ephrata, PA): Farm Wey labeled cantaloupes, Lot #32773301 & 32773302, manufactured by Farm-Wey Produce, Inc. (Lakeland, FL). Four Seasons recalled 1,064 cases (15/case) on November 19th by email, telephone and fax after being informed by New York State that the melons were potentially contaminated with Salmonella. The recalled cantaloupes were distributed to New York, Pennsylvania, Puerto Rico and Bermuda.
  • Combs Produce, LP (Dallas, TX): Natures Harvest Grape Tomatoes, recalled by email on November 25, 2011 due to potential contamination with Salmonella. Approximately 400 cases were distributed to Oklahoma and Texas.
  • Supreme Protein (Manasquan, NJ): Supreme Protein Chocolate Caramel Cookie Crunch (0.71 oz/20g bars; Lot B11272A October 2012), manufactured by Belmont Confections Inc. (Youngstown, OH). The firm initiated a recall by email, letter and telephone on October 11, 2012 of 473 bars, because the product was potentially contaminated with Salmonella. The recalled bars were distributed nationwide.

These are just a few examples from less than 4 months’ worth of FDA Enforcement Reports. For brevity and simplicity, I limited myself to Class I microbiological hazards, and did not include undeclared allergens, foreign material contamination (i.e., metal, glass, etc) or undeclared/unapproved additives.

I was taken to task for my February 9th stealth recall ‘rant’ by Jim Prevor of the Perishable Pundit in his February 15th item “Food Safety, Recalls And Why Consumers Don’t Always Need Notification.” What were his gripes, and how do they stack up in light of what I have found?

Prevor theorized that the E. coli O157:H7-contaminated spinach was not destined for direct retail sale; therefore, he concluded, there was “…no need to notify consumers.”

But, USDA’s Food Safety and Inspection Service routinely publicizes recalls of products that are destined strictly for the institutional market. Why should FDA not do likewise?

Prevor also suggests that the recall was not publicized to avoid worrying or confusing consumers, who would not differentiate between the recalled (curly) spinach from Texas and the unaffected (flat leaf) baby spinach from California and Arizona. He concludes that avoiding a public announcement was the responsible path, to prevent crushing “countless farmers and processors”.

Sorry, Jim, but how does that justification extrapolate to the “Branded” products I’ve cited above – especially those that were sold in retail-sized packaging bearing lot number identification and/or expiration dates?

Finally, Prevor ends his article with the following statement:

One suspects that the decision to not announce recalls when the announcement would not enhance public health is motivated by the desire to protect another value: Maintaining viable farms, industries, jobs, etc.

Interesting. I always thought that the primary responsibility of FDA was to protect public health.

FDA relies on consumers and consumer advocates to help it carry out its broad mandate. The agency has no choice – it cannot afford to inspect more than a tiny fraction of food producers and processors in the USA. But, like it or not, the flip side of this dependency is the need to keep consumers informed. Naive consumers, or those who are ignorant of existing recalls, are more likely to become casualties than collaborators.

When President Obama took office, he promised “transparency” in his administration. I grant that the workings of FDA, USDA and other US agencies are more open than those in many – perhaps most – other countries. Nevertheless, the President’s promise raised the bar for FDA. At the very least, there should be a consistent – and transparent – policy guiding the agency’s decisions on when and how to release information about recalls. This is especially true for FDA-initiated recalls.

Speaking as a consumer, and as a food safety microbiologist with more than 30 years of experience – several of them with Canada’s food safety regulatory agency – I strongly believe that all Class I recalls should be posted promptly on the government’s food safety website.

Consumers deserve – and should demand – no less.

FDA Fines American Red Cross Another $9.6 Million

For the second time in less than 2 years, FDA has levied fines of more than $9 million on the Biomedical Services arm of the American National Red Cross.

The fines are due to violations by the Red Cross of a 2003 Amended Consent Decree of Permanent Injunction. FDA and the Red Cross entered into the 2003 Consent Decree after FDA inspections of various Red Cross biomedical facilities found numerous deviations from FDA law, regulations and the requirements of an earlier (1993) Consent Decree. The biomedical facilities are responsible for ensuring the safe collection, screening, handling and distribution of the nation’s supply of donated blood.

On June 17, 2010, FDA informed the Red Cross that the non-profit organization was to be fined $9,776,000 for violations of the Consent Decree that occurred from 2003 to 2008. The second series of fines, announced on January 13, 2012, covers violations that were documented during a series of inspections carried out from April 2010 through October 2010.

All told, FDA has fined the American National Red Cross $19,368,200.

A number of the violations that were documented during FDA inspections of 16 different Red Cross Blood Services facilities threaten the potential safety of the nation’s donated blood supply. Here are just a few of the more egregious lapses:

  • Failure to establish, implement and continuously maintain managerial control over QA in all regions and laboratories…
  • QA programs were not adequate to ensure that all regulated donor management operations were being performed effectively at the Philadelphia DCSC…
  • Failure to comply with reporting requirements…
  • Inadequate National Donor Deferral (high-risk donor screening) Register…
  • Failure to promptly implement adequate corrective actions to prevent recurrence of the failure to control suspected blood or blood components…
  • Failure to follow Standard Operating Procedure…
  • Failure to establish and maintain a distribution and receipt procedure that includes a system by which the distribution or receipt of each unit of blood can be readily determined to facilitate its recall, if necessary…
  • Failure to ensure that supplies are used in a manner consistent with the manufacturer’ s instructions, and failure to prepare the phlebotomy site using a method that gives maximum assurance of a sterile container of blood…

FDA also underscores in its most recent letter to Mr. Chris Hrouda, Executive Vice President of Biomedical Services for the American National Red Cross that many of the violations enumerated in the January 13, 2012 letter are “virtually identical” to violations reported in previous letters.

As of March 2010, the adult population (15 years of age and up) of the USA was approximately 242 million people. According to the Red Cross web site, 3 out of every 100 Americans – that’s roughly 7.25 million people – are blood donors. I wonder how those 7.25 million people feel about the way the Red Cross is handling their precious Gift of Life.

The American National Red Cross depends on the good will and generosity of millions of people who donate their time, money, and blood to save the lives of total strangers. It’s time that the organization was held to account, not just by FDA, but also by the people on whose generosity it relies for its very existence.

Next time the Red Cross contacts me to ask for a donation, I plan to demand an accounting of how they propose to clean up their act. I suggest that everyone do likewise.