Government Transparency – An Oxymoron: Updated

Oxymoron – a rhetorical device or figure of speech in which contradictory or opposite words or concepts are combined for effect

On June 27, 2012, FDA posted the following notice on its Enforcement Report web page:

FDA is pleased to present a new format for its weekly Enforcement Report. When you select the link below for this week’s report, you will hopefully find a simpler, clearer report that offers downloadable data for analyses while also providing savings and encouraging future innovation for Government. This data-driven report provides FDA a baseline as it moves forward in its efforts to integrate the Agency’s compliance and enforcement data.

The new reporting format is, indeed, easier to use – so much easier, in fact, that it highlights the purely cosmetic nature of FDA’s interest in transparency.

One of my pet peeves with FDA is its refusal to release retail distribution information for food safety recalls. The agency claims that this information is proprietary to the companies who “voluntarily” recall their products. In contrast, USDA’s Food Safety and Inspection Service (FSIS) maintains a policy of releasing retail distribution lists within seven days of a recall announcement. Same government. Different department. Different policy.

Another of my gripes is FDA’s equally adamant refusal to provide a list of countries to which a recalled product was exported, unless the company itself releases that information. Particularly frustrating was the recent series of Diamond Pet Foods Salmonella recalls.

Diamond Pet Foods – and several other companies for whom Diamond manufactured dry dog food – recalled a long list of products after three separate batches of the pet food were linked to a Salmonella Infantis outbreak that sickened 49 people (47 in the USA and 2 in Canada). One of the companies caught up in the recalls was Natural Balance Pet Foods.

On May 4th, Natural Balance recalled 833 tons of dry dog foods in response to the Diamond Pet Foods recall notice. At the time of the recall, consumers were told that the products “may have been” distributed in Alabama, Arkansas, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Wisconsin, West Virginia, Wyoming and Canada.

Consumers were NOT told that the recalled Natural Balance products also were shipped to Taiwan and Israel. That information, which was in FDA’s hands at the time of the May 4th recall, was released today (July 25th) in FDA’s Weekly Enforcement Report.

What is the logic in refusing to release an international (country-level) distribution list at the time of a recall, when the information will eventually be made public anyway?

On June 27th, when FDA introduced its new Weekly Enforcement Report format, I sent the following request to the agency’s Office of Public Affairs:

I’ve been thinking of using the new format of the FDA Weekly Enforcement Report as the jump-off for a blog story about the recall process. I would greatly appreciate answers to a couple of questions. Specifically,

1. What are the criteria that determine when information on a specific recall is included in a Weekly Enforcement Report?

2. Why does FDA not release retail distribution lists for Class I recalls (as FSIS does)? When does consumer protection trump “proprietary” interests?

3. Why does FDA not release information (when it is available) on the foreign countries to which a recalled product was exported? While I realize that FDA’s primary responsibility is to US citizens, the FDA web site is often the SOLE source of this type of information for people (including expatriate US citizens) living in many foreign countries.

I plan to comment on each of these issues in my article, and would appreciate a clear statement of FDA’s current policies and the reasons for these policies.

I received an acknowledgment of my request the next day, asking for my deadline. I indicated that I would appreciate a reply by the end of June. On July 12th, I sent a reminder. As of today, I’m still waiting for answers.

FDA is not the only culprit – or even the worst culprit – when it comes to timely public disclosure of recall and outbreak information. Canada’s federal and provincial health and agriculture agencies are just as bad. Information requests sent to Health Canada, the Public Health Agency of Canada, the Canadian Food Inspection Agency and some of the provincial departments often are ignored completely – acknowledged at times, but rarely answered substantively. Some US states are equally at fault. Idaho, for example, requested that the name of an Idaho mail-order hatchery be withheld from a CDC Outbreak Investigation Report. And the EU publishes a daily list of food and animal feed safety notifications (Rapid Alert System for Food and Feed) without providing any identifying information – neither brand names nor lot numbers – even when the food is implicated in a disease outbreak.

Government agencies are inherently secretive. They can’t help it; it’s in their DNA. President Obama’s earlier promises notwithstanding, we shall never see true transparency from US government departments. Not today. Not next year.

Sadly, the best we can hope for is a reduction in government opacity.

FDA’s response

After sending a link to this article to FDA’s Office of Public Affairs, I received the following replies to my questions:

1. What are the criteria that determine when information on a specific recall is included in a Weekly Enforcement Report?

When the recall is classified it is available for the weekly (by CFR part 7 section 21 CFR) published Enforcement Report.

2. Why does FDA not release retail distribution lists for Class I recalls (as FSIS does)?

Freedom of Information regulations do not permit us to release this commercial confidential information (CCI) information. The following link should be helpful and will provide greater clarity. http://www.archives.gov/federal-register/codification/executive-order/12600.html. In addition, I would need to refer you to USDA of which FSIS is a subpart.

When does consumer protection trump “proprietary” interests?

Congressional mandate when the Freedom of Information Act was passed.

3. Why does FDA not release information (when it is available) on the foreign countries to which a recalled product was exported? While I realize that FDA’s primary responsibility is to US citizens, the FDA web site is often the SOLE source of this type of information for people (including ex-patriate US citizens) living in many foreign countries.

See response #2

Guest Blog: In Defense of Food Safety Leadership

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

In Defense of Food Safety Leadership

by Nancy Donley

My only child, Alex, died from hemolytic uremic syndrome (HUS) caused by eating E. coli O157:H7-contaminated ground beef back in 1993 when he was only 6 years old. It was the most horrendous experience possible.

His first symptoms were severe abdominal cramping and bowel movements that consisted strictly of blood and mucus. Alex suffered terribly as his organs shut down one by one. At one point one of his lungs collapsed, requiring bedside surgery. His brain swelled so horribly that shunts were drilled into his head in an effort to relieve the pressure, but to no avail.

My brave little boy’s last words to me before slipping into a coma were, “Don’t cry, Mommy” as I couldn’t stop the tears from silently flowing. His last gesture to his dad was to blow him a kiss. I was with him when he suffered a grand mal seizure and was put on a ventilator. My little boy, my only child, was dead.

Alex had wanted to be a paramedic when he grew up so that he “could help others” — his words. So when he died we hoped to be able to donate his organs so that he could fulfill that wish of helping others, but his organs were unsalvageable because of the damage caused by the E. coli toxins.

There was no cure for this awful disease then and there still isn’t today. Doctors can only hope to support bodily systems until the toxins pass through. It is for this reason that it is critically important for meat and poultry companies to put into place prevention strategies and technologies to ensure that contaminated meat doesn’t make its way into the marketplace. That’s why we need to support innovations and advances that enhance food safety.

After Alex’s death, I felt compelled — really more like obligated — to fulfill his wish of helping and protecting other consumers by being his voice and working with federal regulating agencies and with companies to see to it that we did a better job as a country in generating a safer food supply. In the process, I have visited numerous meat and poultry plants, have provided input on public policies and food safety laws, and have served on the National Advisory Board for Meat and Poultry Inspection.

One of the many plants I visited was Beef Products, Inc. I got to know the owners, Eldon and Regina Roth, and was impressed by their complete commitment to the safety and wholesomeness of the meat products they produced. I was also impressed by the food safety culture they instilled throughout their company. We shed tears together over what happened to Alex and realized how we share the common goal of preventing illness and death from foodborne pathogens. Ever since that moment, BPI has generously supported STOP and has never asked for anything in return.

That said, one point that needs to be perfectly clear is this: After what I personally experienced watching my son suffer and die, I am very skeptical and cynical about for-profit meat companies and their professed commitment to food safety. Not all companies “walk their talk.” BPI does.

There has been a lot of misinformation swirling around the Internet and on TV about lean beef trim produced by Beef Products, Inc. As I stated earlier, I have personally visited their plant and the categorization of calling their product “pink slime” is completely false and incendiary. Consumers need to understand that this product is meat, period, and that the use of ammonia hydroxide in minute amounts during processing improves the safety of the product and is routinely used throughout the food industry. There are many types of interventions including food-grade antimicrobial sprays which are used on all manner of foods. Some of these things may sound icky and gross, especially when inaccurately portrayed. These interventions are necessary in ridding meat of deadly pathogens and are required to prove they pose no threats to consumers. Companies would be prohibited by the USDA and FDA to use substances that could be harmful in human consumption.

I am very concerned that mis-categorization campaigns such as this “pink slime” campaign will cause well-intentioned companies such as BPI to cease innovations for developing better food safety technologies and strategies. Why try to do something better only to get set up as a target? If this does in fact happen, and promising technologies get thwarted, we, the American public, will be the losers. And tragedies like Alex will continue to go on and on and on.

About the author: Nancy Donley is recognized as a leading proponent of improvement in both government and private food safety efforts since the death of her six-year old son Alex in 1993 from consumption of E. coli O157:H7-contaminated ground beef. Alex was her and her husband Tom’s only child. Nancy works in a volunteer capacity for STOP Foodborne Illness and has served as its president for over 10 years. She has done extensive advocacy work on behalf of the organization and has been featured in numerous magazine articles, newspaper articles and television interviews in efforts to increase awareness about the risks of foodborne illness. Nancy serves on the United States Department of Agriculture’s National Advisory Committee on Meat and Poultry Inspection. She has received numerous awards for her advocacy efforts.

The Real Pink Slime

OK. I get it. You want to have the option of choosing whether or not to buy ground beef that contains Lean Finely Textured Beef. Sorry, I meant “pink slime.”

Now, how would you like the packages of ground beef to be labeled?

Hmmm…

May contain beef that has been treated to kill harmful bacteria? Definitely not. Sounds too healthy.

May contain ammoniated Lean Finely Textured Beef? No. Too technical sounding.

May contain ammoniated defatted finely ground beef? No. Not disgusting enough.

Guess the label should simply declare “Contains pink slime.”

Now that we’ve got that issue resolved, let’s not forget the real risks hiding in those packages of ground beef and pre-formed burger patties – Salmonella, E. coli O157:H7 and other shiga-toxin producing E. coli.

E. coli O157:H7 Photo by Janice Haney Carr, Centers for Disease Control and Prevention

These pathogenic bacteria are the real hazards associated with eating beef burgers. These are the culprits that maim thousands of victims annually – killing some and leaving many others to deal with life-long chronic ailments.