Category: FDA

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.

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

– Ologies & -Isms. Copyright 2008 The Gale Group, Inc.

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

 

US Food and Drug Administration – More Than Just An Enforcement Agency

I was reminded today that the US Food and Drug Administration is more than just an enforcement agency. FDA also supports research into technologies and methods designed to speed the identification of sources of foodborne contamination and to facilitate bringing disease outbreaks under control.

The following article appears on FDA’s Consumer Updates page and is reposted with the permission of FDA.

Genome Project for Food Pathogens Launched

Scientists will be studying and recording the genetic makeup of bacteria that have caused outbreaks of foodborne illnesses.

The tiny organisms that cause foodborne illnesses—bacteria, viruses and others—are formidable foes. Despite efforts to reduce outbreaks, bacteria like Salmonella, Campylobacter, E. coli and Listeria are pervasive in the environment. Like masters of disguise, they evolve into different strains to adapt to changing surroundings.

These microorganisms are collectively referred to as food pathogens. And they do a lot of harm. Every year an estimated 48 million Americans get sick from a foodborne disease, 128,000 are hospitalized, and 3,000 die, according to the Centers for Disease Control and Prevention (CDC).

Despite progress in our understanding of these pathogens, there is a lot that scientists do not yet understand, including where these harmful organisms live, how they survive or multiply in the environment, and whether some geographic locations affect them in unique ways.

To answer these and other questions, the Food and Drug Administration (FDA) is embarking on a five-year collaboration with public and private partners to create a public database of the gene sequences of 100,000 bacteria that have been responsible for outbreaks of foodborne illnesses around the world. Gene sequences are the ordered chemical building blocks that make up the bacteria’s DNA.

The goal of this effort, called “The 100K Genome Project” is to give public health officials the tools they need to more rapidly identify the source of the contamination and bring these outbreaks under control, says Steven Musser, Ph.D., director of the Office of Regulatory Science in FDA’s Center for Food Safety and Applied Nutrition (CFSAN).

The Practical Applications

Musser explains that this new database containing the genetic codes of food pathogens will:

  • enable scientists in both the public and private sectors to develop tests that can identify the bacteria present in a sample within days or even hours.
  • help investigators discover the likely source of an outbreak. For example, a cluster of Salmonella illnesses is detected using current testing procedures but the contaminated food is not easily identified. A test would reveal what bacteria is present in the person’s body and the genome database could indicate where that strain or one like it came from the last time it was detected. That would point investigators in the direction of a specific food or region.
  • greatly expand the pool of researchers able to develop software for the diagnosis and analysis of potential hazards that could lead to new methods of preventing and controlling outbreaks. Making this information available to the public means that researchers throughout the world can use it. “If we keep this information to ourselves at FDA, we’re limited to just what we can think of doing with it,” says Musser.

A Public-Private Collaboration

This initiative is a collaboration between FDA, the University of California/Davis, and Agilent Technologies Inc.

The genomic sequencing will be done at a new facility at UC Davis that will coordinate the overall effort. As the gene sequences are completed, they will be stored in the National Institutes of Health’s National Center for Biotechnology Information’s public database.

FDA is providing hundreds of genetic sequences its scientists have already drafted, thousands of actual food pathogens for additional sequencing, and other technical support. Under a cooperative agreement grant to UC Davis, FDA scientists will guide the project and provide technical assistance.

Agilent—a company that manufactures equipment for electronic and bio-analytical measurement—is supplying expertise, instrumentation and funding.

The list of collaborators contributing to the project continues to grow. For example, CDC and the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) have both joined the initiative.

“FDA is pleased to contribute the scientific and technical expertise necessary to create and maintain this food pathogen database that will be fully accessible and have long-lasting impact on protecting public health,” says FDA Commissioner Margaret A. Hamburg, M.D.

“This initiative shows great promise as we look to improve our ability to identify and track down potential sources of foodborne outbreaks,” said USDA Under Secretary for Food Safety Elisabeth Hagen, M.D. “FSIS intends to submit important bacterial strains from our regulatory testing program for sequencing at UC Davis, and we look forward to the benefits this public database could provide federal, state and local public health agencies.”

CDC will provide its foodborne disease expertise, strains to be sequenced and other information for use in the project. CDC experts will also serve on the steering committee for the project.

The endeavor is also a reflection of FDA’s focus on regulatory science, which is the scientific foundation of FDA’s regulatory decisions, says Musser, who heads a lab at CFSAN with more than 120 researchers dedicated to preventing food safety problems before they occur, and identifying the causes when they do.

As it relates to food safety, regulatory science involves the development of tools, standards and approaches to assess the safety of the foods consumed by people and animals in this country. The database is an important advance, says Musser. “It doesn’t get better than this.”

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This article first appeared on FDA’s Consumer Updates page on July 12, 2012.