Fresh Produce Discussion Blog

Created by The Packer's National Editor Tom Karst

Tuesday, November 6, 2007

FDA Web pages up on Food Protection Plan

Teleconferences are seldom free of glitches, and today's teleconference announcing the new FDA's new Food Protection Plan was particularly painful. Between reporters doggedly trying and failing to get bottom line answers from FDA officials on what the plan means for the budget and workforce and agency officials speaking in generalities and platitudes, the event was fog-shrouded from the start. That was made worse when the line to the press event fell silent and I was left waiting for the event to resume. No matter, the FDA now has its Web site updated with some helpful details about the plan. Here is the link:
Speaking to new authority needed with the plan:

ADDITIONAL LEGISLATIVE AUTHORITY NEEDED
Empower FDA to Issue a Mandatory Recall of Food Products When Voluntary Recalls Are Not Effective
Although FDA has the authority to seize adulterated or misbranded food, this is not a practical option when contaminated product has already been distributed to hundreds or thousands of locations. And while the FDA has been able to accomplish most recalls through voluntary actions by product manufacturers or distributors, there are situations in which firms are unwilling to conduct a recall. In such situations FDA needs the ability to require a firm to conduct a recall to ensure the prompt and complete removal of food from distribution channels. This authority would be limited to foods that the Secretary has reason to believe are adulterated and present a threat of serious adverse health consequences or death. It would be imposed only if a firm refuses or unduly delays conducting a voluntary recall. An order to recall food could only be issued by the HHS Secretary, Deputy Secretary, or Commissioner of Food and Drugs, and would be accompanied by appropriate due process rights.
Provide FDA Enhanced Access to Food Records During Emergencies
During food-related emergencies, the FDA needs more complete and streamlined access to records necessary to identify the source of foodborne illness and take needed action. Improved access to information, including records related to an article of food or related articles of food that may present a threat, will enhance FDA's ability to identify problems, respond quickly and appropriately, and protect public health.
Currently, emergency access to records is limited to instances where, for an article of food, FDA has a reasonable belief that the food is adulterated and presents a threat of serious adverse health consequences or death. FDA proposes to expand access to records of related articles of food, such as food produced on the same manufacturing line. FDA also proposes, in food-related emergencies, to remove the adulteration requirement to allow its inspectors access to records in emergency situations where FDA has a reasonable belief that an article of food presents a threat of serious adverse health consequences or death. The recent melamine situation in which FDA had early clinical evidence that a specific food was causing illness in pets but did not have clear evidence of a specific adulteration is an example of such a scenario.
The records access would relate only to safety or security of the food and would not apply to records pertaining to recipes, financial data, pricing data, personnel data, research data, and sales data. The requirement would not impose any new recordkeeping burdens, and would maintain the current statutory exclusions for the records of farms and restaurants.

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