Lab Error Triggers Product Recall

There’s a third-party contract lab located somewhere in Canada that needs to review its Good Laboratory Practices and lab sanitation protocols.

On October 5, 2011, the Canadian Food Inspection Agency (CFIA), in conjunction with Foodfest International 2000 Inc., warned the Ontario public that Strubs ready-to-eat Danish Style Smoked Grav-Lox Atlantic Salmon (Lot code 09262011) should not be consumed.

The Grav-Lox, according to CFIA, might be contaminated with Salmonella. Foodfest International 2000 Inc. (the distributor) recalled the offending product.

That was one month ago.

Today, CFIA rescinded its Health Hazard Alert, and advised the public that the Strubs Grav-Lox did NOT present a health risk from Salmonella.

Why the reversal? Because, according to CFIA, the lab responsible for reporting the initial Salmonella-positive result found that “...the Salmonella positive result was in fact a false positive, attributed to laboratory cross contamination.”

Now, I’ve worked in – and managed – several microbiology labs in my professional life. And I’m here to tell you that the LAST thing that should happen in a professionally run lab – whether government, in-house company, or third-party lab – is laboratory cross contamination.

Aseptic technique and assiduous attention to proper lab sanitation procedures are fundamental to the production of dependable lab results. So is the routine use of positive control and negative control sample analysis.

The company for whom the third-party lab did its analyses should have three questions for the lab’s management:

How did the lab cross-contamination happen?
Why did it take a full month for the cross-contamination to be discovered?
How will the lab change its procedures to ensure that the same thing doesn’t happen again?

I don’t know who hired the third-party lab; it could have been either Strubs or Foodfest (CFIA maintains its own labs). But, if I was the one who hired that hapless excuse for a professional lab, I’d be looking for a replacement, ASAP.

FDA’s Puppet Master

Anyone trying to figure out who pulls FDA’s strings on retail distribution information policy for Class I recalls need look no farther than the Grocery Manufacturers Association (GMA).

Every time a major food safety recall is announced, eFoodAlert receives questions from consumers who are trying to find out whether their favorite supermarket carried the recalled product. This was especially the case during the Jensen Farms cantaloupe recall, as not all of the recalled cantaloupes were individually labeled.

Two weeks ago, Harry Hamil (owner of Black Mountain Farmers Market and a regular eFoodAlert reader) took me to task over my rhetorical question “When is FDA going to wake up, put the health and safety of American consumers ahead of industry interests, and provide us all with timely and complete information?”

My specific complaint was over FDA’s refusal to release retail distribution information for Listeria monocytogenes-contaminated Jensen Farms cantaloupes. Harry challenged me to make three phone calls:

To the White House, asking why USDA releases retail distribution lists while FDA does not;
To the Western Growers Association, asking their position on release of this information; and
To the Produce Marketing Association, asking their position of the release of retail distribution lists.

I followed up on Harry’s challenge by sending email requests to the Western Growers Association, the Produce Marketing Association and the Grocery Manufacturers Association, asking each of them for their position on the release of retail distribution lists for all Class I (highest hazard level) recalls. (I didn’t bother trying to contact the White House. My past efforts to do so have resulted in either no response or a “thank you for your interest” reply.)

The Produce Marketing Association never replied to my email, even though I made two attempts to contact them.

The Western Growers Association‘s Senior Vice President, Hank Giclas, responded that “WG does not have a formal position on the question of identifying retailers who sold recalled product.”

Brian Kennedy, spokesman for the Grocery Manufacturers Association (GMA) had this to say:

“During a recall consumers should focus their attention on the specifics of the recalled product itself (i.e., name, variety, size, lot code). In a FDA Class I recall, all of this info is made public. Releasing a public list of all the retailers where the recalled products were sold does not make sense from a food safety perspective. Any proposed list could change from week to week or even from day-to-day so if consumers were not constantly monitoring this list for any changes, they could inadvertently purchase the recalled product. Also, even if they were monitoring the list closely, the list might not necessarily be accurate. In addition, some shoppers might not be able to remember exactly where they purchased a particular item.”

This is what FDA Commissioner Dr. Margaret Hamburg had to say about releasing retail distribution information in her introductory statement during a media teleconference on September 28, 2011:

“[C]onsumers can inquire of their retailers where cantaloupe came from, and retailers are prepared to provide that information if they are not already providing it to you in their stores.”

And, in replying to a reporter’s question about releasing retail distribution information, Dr. Hamburg added,

“I think it’s a lot more accurate for the consumer to actually ask their retailer in terms of the ability to get that information out and, of course, when you put stuff on the web site, not everybody accesses it. So I think it is an important message that if people are uncertain to ask their retailer. That’s how they’ll get the most accurate and most direct information.”

Am I crazy, or is FDA allowing the Grocery Manufacturers Association dictate Agency policy on release of retail distribution lists?

I repeat the rhetorical question with which Harry Hamil took exception two weeks ago:

When is FDA going to wake up, put the health and safety of American consumers ahead of industry interests, and provide us all with timely and complete information?

FDA’s – And Obama’s – Broken Promises

“There are certain things that only a government can do. And one of those things is ensuring that the foods we eat …are safe and don’t cause us harm.”

President Barack Obama, March 14, 2009

Anyone who believes that the Food Safety Modernization Act protects this nation’s consumers from foodborne disease outbreaks is dreaming in Technicolor. And anyone who believes that the Federal Food, Drug and Cosmetics Act protects consumers from harmful drugs, cosmetics and medical devices is equally self-delusional.

Consider this:

Jensen Farms, the source of Listeria monocytogenes-contaminated cantaloupes that are responsible for 125 illnesses and 27 deaths, registered with FDA in 2011. FDA officials, speaking during a media teleconference last week, confirmed that the company’s operations had never been inspected by FDA, and that Jensen Farms was not scheduled for inspection until sometime between 2015 and 2017 – 5 to 7 years after registration – as specified under the Food Safety Modernization Act.
Larry Schultz Organic Farm, a free-range shell-egg producer that was linked last week to six cases of Salmonella Enteritidis infections in Minnesota, was not covered under FDA’s Egg Safety Rule, because the company maintains fewer than 3,000 laying hens. In contrast, the “small producer” definition in the United Kingdom is fewer than 350 laying hens. FDA has no plans to inspect shell egg producers that maintain fewer than 3,000 hens.
CooperVision, a contact lens manufacturer and distributor, initiated an international recall of certain of its contact lenses on August 19, 2011. Recall notices were posted on government web sites in Hong Kong, Australia, Spain and Italy. The company successfully resisted FDA’s “request” to issue a public recall notice in the USA for almost two months. The Voluntary Recall was announced on October 13, 2011 – only after the shares of CooperVision’s parent company tanked as a result of publicity generated by eFoodAlert and by MSNBC.com’s JoNel Aleccia.
Insight Pharmaceuticals issued a “stealth recall” of more than 34,000 bottles of Nostrilla Nasal Decongestant nasal spray on September 19, 2011. Although a few retailers of the OTC nasal spray posted recall notices, the company only went public with its recall on October 19, 2011, explaining that the product was contaminated with Burkholderia cepacia – a microbe that is capable of causing very serious infections in people with compromised immune systems or chronic lung conditions. Insight exposed its customers to an unnecessary risk for a full month before publicizing its recall. Where was FDA while this was taking place?

The so-called Food Safety Modernization Act – a last-minute “compromise” to salvage a worthwhile project that was being sandbagged by certain”Congresscritters” – has buried FDA and the food industry in a quagmire of mandates and regulatory red tape that threatens to choke off any real progress toward a safer food supply. The situation is no better in the drug, cosmetic and device divisions of FDA, where mandatory recall authority is so tied up in “process” that it is non-existent.

Our tax dollars are being frittered away by pissant politicians who believe it more important to make speeches about the repugnancy of their opponents’ ideas than to reach practical and effective bipartisan solutions to our pressing health and safety problems.

At this rate, we might as well disband FDA’s Food Safety operations and take our chances with the free market. The money we save can be used to defray the medical costs resulting from foodborne disease outbreaks.