An Analysis of the FDA Food Safety Plan

Dec. 5, 2007

Two associates of Washington law firm Keller and Heckman LLP listened in on an FDA audioconference about the Food Protection Plan presented Nov. 6.  Here's their summary:

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On November 16, FDA held a "Stakeholder Teleconference" to discuss the Agency's Food Protection Plan.  Dr. David Acheson, Assistant Commissioner of Food Protection, began the teleconference with an overview of the Plan. FDA then took questions. 

We monitored the teleconference and provide some highlights below.

* In response to questions about not having sufficient data to perform risk based inspections,  FDA agreed that it will need data and help identifying data sources but that it does not have to wait for all the data to become available in order to start a risk based assessment. 

* FDA believes that stakeholder outreach will help FDA find out what data exists and how to secure data received.

* In response to questions as to why the Plan does not address specific issues such as resistance surveillance in food and feed and BSE surveillance, FDA explained that it deliberately decided not to go into specific detail in the Plan. Dr. Daniel McChesney (Director of the Office of Surveillance and Compliance at the Center for Veterinary Medicine) commented that the ARM program to identify trends in antimicrobial susceptibilities and the BSE rule (which will be issued shortly) will be integrated into the Plan. 

* In addition, FDA explained that the Plan does not directly address working with CODEX and other international bodies because the Plan was meant to focus on what FDA is hoping to accomplish, such as directly working with foreign countries, such as China.

As for budget issues, FDA explained that the Agency is currently under a continuing resolution and that limits what can be done through December 2007. The budget request for 2008 was complete before the Plan was developed. The budget request for 2009 will be heavily influenced by the Plan and submitted in February 2008.

The Plan will not have any impact on memorandums of understanding (MOUs) between FDA and USDA.

FDA was asked if it was planning to seek legislation that would require submission of attribution data (including requiring states to submit information) and whether it was going to make product and ingredient trace back mandatory. FDA responded that there is no plan for mandatory reporting. FoodNet (CDC's Foodborne Diseases Active Surveillance Network) works well in the sites where it is in place, but is not good at attributing an illness to a specific food. FDA is working with CDC to improve this. The system depends on state and local input. FDA is focusing on what is doable and it is not going to seek the authority to require reporting since it is not feasible.

FDA's response to the need for mandatory trace back was similar; they will explore this in the future but it is not doable right now, especially since it's not clear what the scope of mandatory trace back would be-- what is the best way to trace and how far back do you go?

Another question addressed the accreditation of private third parties to inspect facilities and how to ensure that the paid inspectors will not be unduly influenced. FDA responded that there would be an audit process and other oversight.  FDA understands that the financial interests of the inspectors will be an issue.  They pointed to the current program for medical devices as a model-FDA shares information with Canada and audits can be by accredited third parties; it places responsibility on the regulated industry to keep its house in order.

In addition, FDA does not have to accept the results of voluntary third party audits. FDA was open to discussing the following-- if inspections are voluntary, then what is the value since an unsatisfactory inspection need not be reported? FDA felt that voluntary inspections could be an asset in the event that there were 2 manufacturers that FDA did not have any information on but one could submit voluntary inspection results, then the Agency would focus resources on the manufacturer that had not undergone a voluntary inspection.

In response to complaints that feed regulation is not a big enough part of the Plan, Dr. McChesney  assured that CVM was involved in developing the Plan and that the Animal Food Safety System and other mandates (Food and Feed Processing regulations) will be integrated.

Next steps for FDA include: working on specific statutory language, continuing to brief members of the House and Senate, particularly those with related bills already in the works and continuing to offer Congress technical assistance.

Setting priorities will be difficult for FDA since they do not know yet what resources are available.  FDA will focus on continuing dialogue with stakeholders and building on prevention, intervention, and response elements; they will not move forward on areas that are resource intensive.

One question asked since FDA is operating on a continuing resolution for funding, what are your top three priorities if the '08 budget is passed? FDA explained that they were in the process of making that determination but identified the following 3 key elements:
1) dialogue on how to acquire data,
2) legislation – especially for third-party accreditation, and
3) working with foreign governments.

In conclusion, FDA urged all parties to remain engaged and contact the Agency with more input.  More teleconferences are planned.

-The link for FDA's Food Protection Plan:

-A replay of the teleconference is available by calling 800-860-4694
(U.S.) or 203-369-3365 (International).

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