Guest Blog: Does The “No Illnesses” Language Belong in Recall Notices?

The following Guest Blog first appeared on Food Safety News, and is reproduced here with the kind permission of its author, Dan Flynn.

Does The “No Illnesses” Language Belong in Recall Notices?

by Dan Flynn

Food companies that are voluntarily recalling a product usually use the language suggested by regulatory agencies that is then distributed electronically via the federal government websites. Recalls not connected to outbreaks almost always contain a line saying there are no reported illnesses associated with the recalled product.

William F. Keene, Oregon’s senior state epidemiologist, thinks it’s time for reporters and editors to “not let themselves be duped into amplifying press release boilerplate.”

Both the U.S. Food and Drug Administration (FDA) and USDA’s Food Safety and Inspection Service (FSIS) have templates for companies to use when writing a recall announcement. They are:

FDA: ”No illnesses have been reported to date.”

FSIS: “There have been no reports of illnesses associated with consumption of these products.”

“Until they have the isolate(s) serotyped, have PFGE’d (conducted a pulsed-field gel electrophoresis analysis), and compared to PulseNet or analogous data,” says Keene, “they are just blowing smoke.” He says that without subtyping data, the media should not fall for it. The only accurate report is that there is no way of knowing (at this time) if there are any associated illnesses.

Dr. David Acheson, who previously held top posts at both FSIS and FDA before becoming a partner at Leavitt Partners, says Keene “is correct, but nobody other than a microbiologist would know that the heck that means and the basic statement from the regulators is still correct.”

Acheson says the point of recall announcements is to answer the public’s “what should I do” questions, and he prefers keeping it “simple and specific.” Acheson says he might add the word “yet” to statements about no illnesses being reported.

Phyllis Entis, the food safety microbiologist and author, who publishes the highly respected eFoodAlert, covering food recalls worldwide, goes a step further than Keene.

“I think that an absence of a ‘no illnesses’ statement would be preferable to the current boilerplate,” she says. “I agree that we should be asking the question, and I have queried CDC in some cases. At times, I even get an answer!”

And Entis notes that boilerplate is used worldwide. The XL Foods recall, the largest beef recall in Canada’s history, originally came out with this line from the template: “There have been on reported illnesses associated with the consumption of these products.”

A short time later the Public Health Agency of Canada (PHAC) was confirming 18 cases of E coli O157:H7 from XL’s contaminated beef.

Keene, who has solved many a multistate outbreak, admits he is motivated by a desire to “light a fire” under food companies to get them to turn over isolates to public health labs so they can be subtyped. Only then can the food isolates be matched to any human cases that might exist.

“As you can imagine, Keene says, “this is not a prospect that excites many food processors, as it literally asking for trouble. I think making it clear that we don’t know if there might be illnesses will prompt people to ask more of the right questions.”

Keene notes that often-ill people who are matched to contaminated food are never asked (or told) if they ate it. He says the system is complicated, with the left hand often not knowing what the right hand is doing.

Carol L. Tucker-Foreman, distinguished food policy fellow at the Consumer Federation of America and USDA’s former Assistant Secretary for Food and Consumer Services, says where there is a recall, there is risk.

“The current FSIS language suggests that there are no reported illnesses as yet and therefore no risk to public health,” she says. “But if that were the case there would be no recall. The recall means the company and FSIS know some meat from the recalled lot is available to the public. That means there is some continuing risk and the agency should say so.”

With her experience in and out of the federal government, Tucker-Foreman says both FDA and FSIS “are eager not to alarm the public unnecessarily or create to much of a problem for the company where there’s no reported illnesses.”

She says food companies “particularly hate the fact that a press release and recall occur based only on plant testing, However, there is no recall unless FSIS believes some contaminated product left the plant and has not yet been recover.”

For his part, Keene is the first to acknowledge that most recalls are not associated with illnesses. However, he says, that is only partially true because nobody is asking. If isolates were turned over to public health labs and searches for matches conducted, then we’d know more about whether or not there were illnesses.

Keene says even then if the test produced a common pattern and there was no spiking of the pattern, its unlikely CDC would bother getting back to “state epi people” and the matches might not be contemporaneous enough to make it worthwhile to health officials to get back in touch with the ill people.

Keene was last in the national news in September 2011 when Del Monte Fresh Produce dropped a lawsuit against the epidemiologist that some said sought to put the science of epidemiology on trial. Del Monte was upset because some of its Central American grown cantaloupe were subjected to an import alert.

About the author: Dan Flynn is a Denver-based writer and editor with more than ten years of food safety experience. As a public affairs professional, he worked with government and regulatory agencies at the local, state, and federal levels. At present, he is Editor of Food Safety News.

Guest Blog: Going Public The FDA Way

The following Guest Blog first appeared on barfblog.com, and is reproduced here with the kind permission of its author, Doug Powell.

Going Public: there may be some rules but FDA says they’re a secret

by Dr. Douglas Powell

The same agencies that tout a science-based approach to foodborne illness aren’t so good at one of the 3 legs of the risk analysis stool – risk communication.

It gets lots of pandering, but almost all government agencies and industry groups, regardless of geography, are really bad at risk communication when performance is stacked up against what has been proven to work (not very much).

When to go public about health warnings – like potential outbreaks of foodborne disease – remains contentious. And no one is willing to come clean about it and say, this is when we go public and why. Or at least write it down. Bureaucrat 101 – write it down, have to do it; so don’t write it down.

I understand the flexibility public health types require to do their jobs effectively, but much of the public outrage surrounding various outbreaks – salmonella in tomatoes/jalapenos, 2008, listeria in Maple Leaf deli meats, 2008, the various leafy green recalls and outbreaks of 2010, 2011, 2012, the 1996 outbreak of cyclospora linked to Guatemalan raspberries, and the delay in clamping down on Iowa eggs – can be traced to screw ups in going public.

It’s long been a tenet of risk communication that it is better to go early with public information rather than later. People can handle all kinds of information, especially when they are informed in an honest and forthright manner.

So it’s of no surprise that the U.S. Government Accountability Office (GAO) couldn’t find anyone within the Food and Drug Administration (FDA) to say, this is how we decide when to go public.

“FDA has interim internal procedures describing the steps it will take to order a food recall, but these procedures have not been made public, and the agency has not provided information on when they will be. Federal internal control standards call for federal agencies to clearly document
policies, procedures, techniques, and mechanisms for implementing management directives and to make that documentation readily available for examination.”

“Similarly, FDA officials told us that they have not decided whether they will issue regulations or industry guidance to clarify for the public FDA’s procedures for ordering food recalls and that FSMA has no requirement to do so. Federal internal control standards direct federal agencies to
ensure adequate means of communicating with and obtaining information from external stakeholders who may have a significant impact on the agency achieving its goals.

“About a week-and-a-half before our closing meeting, FDA officials provided us interim internal procedures for ordering recalls of food. These interim procedures include detailed information on such topics as which officials are to be involved in an ordered food recall decision and what methods and timelines FDA officials will use to communicate with companies involved in such a recall. The interim procedures also state that FDA is to incorporate procedures into the
agency’s publicly available Regulatory Procedures Manual and other FDA documents. FDA officials have not, however, provided timelines on when they expect to make procedures publicly available.”

And it goes on like that for 61 pages.

GAO recommends, among other things, that FDA issue regulations or industry guidance to clarify its ordered food recall process and implement recommendations from others to address FDA communication challenges in advising the public about food recalls and outbreaks. The agency neither agreed nor disagreed with GAO’s recommendations but cited ongoing agency actions that are to address most recommendations.

To strengthen FDA’s process for ordering recalls, the Secretary of Health and Human Services should direct the Commissioner of FDA to document FDA’s process for ordering food recalls in regulations or industry guidance to include information on how the agency will weigh evidence on whether a recall is necessary.

To address FDA’s communication challenges in advising the public about food recalls and outbreaks, the Secretary of Health and Human Services should direct the Commissioner of FDA to implement recommendations from the Institute of Medicine and National Research Council to develop, in conjunction with other federal agencies, a coordinated plan for crisis communications.

To address FDA’s communication challenges in advising the public about food recalls and outbreaks, the Secretary of Health and Human Services should direct the Commissioner of FDA to implement recommendations from FDA’s risk communication committee to develop a policy for communications during emerging events.

The full report is available at http://www.gao.gov/products/GAO-12-589.

About the author: Dr. Douglas Powell is a professor of food safety at Kansas State University and the publisher of barfblog.com. Powell is passionate about food, has five daughters, and is an OK goaltender in pickup hockey.

Guest Blog: Going Beyond Legal

It’s not often that I come across an industry consultant who tries to call the public’s attention to deficiencies in the practices within his own industry. Mr. McNaughton’s article highlights the practice of “grandfathering” – a practice that allows older procedures, equipment and building designs to continue in operation even when they no longer represent “Current Good Manufacturing Practices.”

The following Guest Blog first appeared on Cheese Reporter (Volume 137, No. 1, June 29, 2012), and is reproduced here with the kind permission of its author, Neville McNaughton.

Going Beyond Legal

Grandfathering: What Is It and If Consumers Knew

by Neville McNaughton

As an advisor to cheese makers, investors, and anyone who wants to be a part of the dairy processing industry, the practice of grandfathering is the most difficult to understand.

For those unfamiliar with the concept of being “grandfathered in,” it is the practice of allowing an operator who was in production prior to a change in safety regulations to not be required to meet the same upgraded standard as a new entrant into the industry.

This is a common practice and one that is perhaps the most difficult to understand. As a rather literal person, regulations to me are regulations and they should apply to us all. It so happens that this is not the case. If you were fortunate enough to have been in operation prior to the introduction of a new rule, there is a possibility that you will not have to comply.

This is unacceptable on many levels: Food safety regulation should have only one function — that of protecting the health and safety of consumers. This protection is far more important today than in the past as the consuming public is more removed from the production of food than ever in history.

Consequently the consumer has little chance of being able to assess the food they consume. Caveat Emptor! Generally I mean this in a technical sense, but in all fairness, our food is being produced farther than ever from its point of consumption. The distance food now travels is revealing, and has led to the rise of movements like the “10, 20 or 100-Mile Diets” to promote healthier eating that also supports the local food supply.

If public health and safety is the goal of regulation, then one would think that as new discovery and processing requirements come into play, operators would be required to meet the standard. No? I can assure processors that consumers do expect and believe this; they do not accept two standards where only the new operator meets the safety requirements.

Sound like a Tale of Two Industries?

Grandfathering is definitely not just an issue for small operators. One of the most glaring/disappointing cases in recent history was a Listeria issue in a large meat plant.

After several years of analysis the reports are telling us that a contributor to the problem was the age of the building, which determined its design and construction methods. The reports are never totally illuminating because, as consumers, we are expected to accept that our inspection agencies are looking into the issues in great depth and somehow that will solve the problem. The plant in question is still in production today. Sounds like Band-Aids were added, doesn’t it?

At what point should our regulators sit down with a processor and advise them that their building and equipment need to be upgraded or replaced?

Let’s consider the state that banned raw milk cheese production while allowing one historical producer to continue. Where is the level playing field? Who needs the upgrades?

The Grade A processor who is operating in an historical building with wooden ceilings?
Grade A processors who have shields above their filling operations to stop drips contacting product and packaging as it is being filled?
The cheese maker who has trays on the top of his cheese to stop drips landing on the cheese?
The cheese packaging operation that has drips falling down on the filling line from HVAC registers in the ceiling?
The cheese maker who was told (an independent consultant was brought in to audit and advise) to add a positive air system to their production space when they had a Listeria problem before they could recommence production? (Other new operators setting up in the same state after this incident were required to put in extract fans only, no filtered air in, and were permitted to operate with open screened windows).

These may seem like trivial issues, but if something in a drip is unsafe for a product for instance, consider how far the drip splatters when it hits the horizontal shield. You can see how the problem grows exponentially.

Regulatory discrepancies happen because of the many influences in the System. An impacted industry puts pressure on their local politician, local politician puts pressure on the top bureaucrat, and it’s all downhill from there.

Observing operators with influence has never made me comfortable. What makes operators and their industries good is whether or not they make good decisions. A checks and balances system is absolutely necessary for regulating the decisions surrounding food processing safety.

If food safety is as much about attitude as it is about regulation, “Grandfathering” is an attitude problem. It shows arrogance on the part of the operator, weakness on the part of the regulator, and corruption (or at the very least confusion) on the part of the politician.

The politician can be a problem because he/she is frequently unduly influenced by the business operator in his electorate. The politician wants profitable businesses in the district to create jobs etc. but he or she should not be able to overwhelmingly influence the decision-making processes surrounding public health and safety. The situation is compounded when states do not have similar regulations. Can the operator just pick up and move across the state line?

Additionally, many states do not enforce their own regulations equally. As an example, a new construction must have brine tanks set away from walls to ensure easy cleaning while existing operators are required to make no changes.

But in one case, a new operator was permitted to build brine tanks into a corner with no provision for cleaning. They placed a freon-based evaporator in the room directly above the brine tank, further impacting the potential for dripping from the condensate tray, the potential for leaking from the condensate tray and condensate drain that led the condensate away to waste.

If condensate drains are not properly installed, they certainly can leak. The freon gas lines to and from the evaporator are insulated, frequently becoming a major source of drips and contamination.

I have a long history of working with regulators and inspectors. What were acceptable practices when I began in this industry are not acceptable today and certainly should not be. I am certain that if we had consumers on a committee along with federal and state regulators, the Grandfather rule would be gone.

Remember that many of the top federal regulators came from the industry they regulate, so they already work closely with the processors. The potential for influence is clear. The creation of a working regulatory committee that includes consumers would improve the dynamic that has led to the current situation.

There is much room to improve the way we run our food industry. There are challenges ahead for which we either don’t have solutions or don’t want to make the change mostly because of cost.

Remove the Grandfather rule and we can expect to see change occur more quickly.

About the Author: Neville McNaughton, president of Cheez Sorce, St. Louis, MO, has many years of experience manufacturing dairy products in both New Zealand and US. He has been a judge at several cheese competitions. Neville writes a regular column in Cheese Reporter.