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

CDC Declares Diamond Pet Food Salmonella Outbreak “Over”

CDC has just released the “Final Update” covering its investigation into cases of human Salmonella Infantis illnesses caused by contaminated dry dog food.

As of today (July 18, 2012), CDC has confirmed 47 cases of Salmonella Infantis in 20 US states; two additional cases were reported in Canada, bringing the total number of known human cases to 49.

Most illnesses developed between January 4th and June 26th. Of the 24 victims for whom information was available, 10 (42%) were hospitalized. The youngest outbreak patient was less than a year old; the oldest was 82.

There is no way of knowing how many dogs and cats were infected, as no government agency in either the USA or Canada tracks reports of animal illnesses. eFoodAlert has learned of at least 54 animals who became ill after being fed a dry pet food manufactured by Diamond Pet Foods in their Gaston, SC production plant. Eight of the 54 animals died.

The 47 US illnesses were identified in Alabama (2), Arkansas (2), California (3), Connecticut (2), Georgia (2), Illinois (4), Indiana (1), Kentucky (1), Michigan (2), Minnesota (1), Missouri (3), New Jersey (2), New York (5), North Carolina (5), Ohio (3), Oklahoma (1), Pennsylvania (3), South Carolina (2), Texas (1), and Virginia (2). The two Canadian victims were residents of Quebec and Nova Scotia.

Geographic distribution of US Salmonella Infantis cases traced to Diamond Pet Foods dry pet food products

The outbreak investigation developed an interesting twist – a second strain of Salmonella Infantis was found in a dog food sample collected from the home of an ill person in Canada. This genetically different strain of Salmonella Infantis was identical to the strain recovered from sixteen human cases of salmonellosis in the USA. Those 16 cases are included in the total of 47 confirmed US cases. Ironically, the Canadian patient was infected with a strain of Salmonella that was not associated with the pet food outbreak.

As I reported on May 15th, FDA inspected Diamond’s Gaston production plant and found a number of significant deficiencies in the company’s procedures and sanitation. The Salmonella Infantis outbreak strain was recovered from samples of finished product; however, none of the environmental or ingredient samples tested by FDA were contaminated with Salmonella. Unfortunately, we’ll never know how the finished pet food became contaminated.

This outbreak of Salmonella illnesses has implications beyond the borders of the USA and Canada. Some of the recalled pet food was shipped to other countries in Europe and Asia. Neither FDA nor Diamond has been willing to provide a list of countries to which the products were shipped, although some of this information is available from recipient countries or distributors.

Additional information on the international distribution of the recalled food is likely to seep out as FDA adds the pet food recalls to its Weekly Enforcement Reports. In today’s report, we learned that the Solid Gold products affected by this recall were supplied to Singapore (confirming information released by Singapore on May 29th), as well as to Canada and the USA.

CDC has evolved a very effective system for identifying possible human disease outbreaks, and cooperates closely with other federal, state and public health agencies in the investigation of these outbreaks. Unfortunately, there is no similar system in place to detect disease outbreaks in companion animals.

FDA “accepts” reports of pet illnesses that may be associated with pet foods, treats or medications; however, there is no mechanism in place for tracking and collating these reports. Nor is reporting of these illnesses mandatory. As a result, hundreds of dogs and cats may have become ill and dozens may have died unnecessarily before this outbreak affected enough people to become visible to CDC.

It’s bad enough when human illness is the “early warning system” for contaminated human food. Why should people also be used as the mineshaft canaries for contaminated pet foods?

Chicken Jerky Pet Treats – FDA Does Data Dump

FDA did a data dump today. The agency has made available for download the results of 5 1/2 years worth of pet treat lab analyses.

This unprecedented release of (relatively) raw lab data by FDA comes on the heels of JoNel Aleccia’s July 13th article on the more than 1,000 pet illnesses and deaths being blamed on chicken jerky pet treats.

When eFoodAlert last contacted FDA’s Center for Veterinary Medicine on this subject in February 2012, the level of frustration felt by the agency was clear in the response we received from FDA Spokeswoman Laura Alvey.

“Testing continues and is ongoing,” Alvey said back then in reply to my questions. “We have tested samples from all over the country.”

Among the tests Alvey mentioned were Salmonella, and chemical toxicants such as melamine, melamine analogs and diethylene glycol. Alvey explained that FDA’s regulatory hands were tied until its scientists could detect a contaminant and demonstrate that a product was adulterated. “The regulations don’t allow for products to be removed based on complaints,” she emphasized.

It’s clear from today’s data dump that FDA has not made any further progress in solving the mystery. In my opinion, the absence of progress is due to two factors – lack of resources dedicated to researching the problem, and lack of a systematic approach to the problem.

Since November 18, 2011, FDA’s various District Offices have collected and analyzed a total of 48 samples of various brands and varieties of pet jerky treats in six district and regional FDA labs. That’s roughly one sample per lab per month. Twelve of the samples were tested for Salmonella; 30 were analyzed for the presence of ethylene glycol, diethylene glycol and/or propylene glycol; 12 were examined for melamine and cyanuric acid. An occasional sample was also examined for other microbial or chemical contaminants. Some samples were analyzed for multiple microbiological and chemical contaminants; others were subjected just one microbiological or chemical test.

In fairness, the data released today by FDA may not be complete. They include only those product samples for which the word “Jerky” appeared on the product label or in the product description. A product labeled simply as a “Pet Treat” or “Pet Chew” would not be part of these data.

There is no way to tell what motivated the selection of tests to be run on a given sample; that information is not included in the data dump. Nor do we know why these samples were collected. Were they part of routine surveillance? Were they the result of a consumer complaint or “adverse event” report? Were they taken during a pet food production plant inspection? This information, too, is lacking.

So far, all of the tests results have been negative, except for the finding of undeclared propylene glycol in twelve samples. Propylene glycol is on FDA’s Generally Recognized As Safe (GRAS) list of food chemicals and ingredients, both for human and animal consumption. Thus, even though the ingredient was not listed on the package label, no regulatory action was “indicated” according to FDA.

Propylene glycol is a humectant – it keeps a food soft, moist and chewy. It also is an antifreeze, although it is far less toxic than other common antifreezes, namely, ethylene glycol and diethylene glycol. But propylene glycol, at certain exposure levels, can be toxic to dogs and cats. And I have not been able to find any studies that evaluate the effect of propylene glycol in combination with other possible pet food ingredients.

Furthermore, has anyone at FDA thought to examine the chemical reactions involving propylene glycol that may take place during the manufacture of pet treats? Dow Chemical lists several reactions that could occur under favorable conditions of heat and oxidation. Has anyone investigated the effects of irradiation on propylene glycol? Some manufacturers irradiate their pet treats to ensure microbiological safety. There are, no doubt, several possible avenues of research here.

Come on, FDA! It’s time to pause, breathe, and start thinking outside the treat bag.