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.

One thought on “Guest Blog: Going Public The FDA Way

  1. Doug: I now give the following presentation – perhaps it would help even FDA.
    Truthiness, Scientification and Bullshit in Communication – From Public Health to Politics.
    Presented by G.W. (Bill) Riedel, Ottawa –
    Writers need to “develop a built-in bullshit detector.” (Hemingway) and so do readers!
    Canadian academic and author Laura Penny opens her book – ‘Your Call is Important to Us, the Truth about BULLSHIT’ (There are at least 10 books in Ottawa public libraries with the word bullshit in the title, most of them written by academics) by quoting Lilly Tomlin: “No matter how cynical you become, it is never enough to keep up.” She then delivers her own judgement by starting the book with the observation: “We live in an era of unprecedented bullshit production” thereby joining other authors who have made similar claims. For example:
    Neil Postman – 1969 – “every day in almost every way people are exposed to more bullshit than it is healthy for them to endure….” He further notes that “the best things schools can do for kids is to help them learn how to distinguish useful talk from bullshit.”
    Harry Frankfurt – 2005 – begins his book ‘On Bullshit’ (translated into 26 languages) with “One of the most salient features of our culture is that there is so much bullshit.”
    Stephen Law – 2011 – Believing Bullshit notes – ‘It seems to me that every child should have some immunity to bullshit built into their upbringing.”
    In spite of this there are few attempts to examine the human propensity to bullshit, especially as it exists in public health and politics. This presentation will survey much of the academic literature on the subject.
    Perhaps the most important question to be examined will deal with potential legal consequences for bullshitters – Andrew Aberdein deals with the question in, Raising the tone: Definition, Bullshit, and the Definition of Bullshit, Chapter 10, page 152 of Gary L. Hardcastle and George A. Reisch, 2006, Bullshit and Philosophy – guaranteed to get perfect results every time, Open Court, Chicago. Aberdein observes: “In British and American common law, a civil claim for negligence arises when the defendant has a duty of care to the plaintiff which he neglects to exercise, thereby harming the plaintiff. Here the deceptive bullshitter has a duty to tell the truth; neglecting this duty harms his audience if they come to believe his false statements…. The associated culpability can range from inadvertence to willful blindness”.
    If you are not concerned about culpability perhaps finding out what BBB, ABB and BBSN stand for might be sufficiently of interest to attend this presentation. The end of leadership in the age of mba?
    Increase the efficiency of your organization by declaring: THIS IS A BULLSHIT-FREE ZONE BECAUSE IT IS NOT NICE TO BULLSHIT YOUR FELLOW CITIZENS BECAUSE BULLSHITTING IS BULLYING!
    Berkun, Scott – #53 – How to detect bullshit – http://www.scottberkun.com/essays/53-how-to-detect-bullshit/, August 9, 2006(accessed Nov. 23, 2010). (The first rule is to expect bullshit).
    “Postman’s core message, which I would summarize as, Citizens living in a democracy, if they hope to keep that democracy, need to learn how to tell the difference between facts and bullshit.” (www.democraticunderground.com)

    Like

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