How will FDA Inspect all Those Food Plants?

Under the Food Safety & Modernization Act signed into law earlier this year, the Food & Drug Administration is expected to inspect some 19,200 foreign food facilities by 2016. That lofty goal is “almost certainly unattainable considering budgetary limitations,” according to Robert Hahn, an attorney for OFW Law speaking at the latest Food Institute webinar on the FSMA – part of the association’s ongoing series. To give you an idea of how “lofty” that goal is, FDA inspected just 153 foreign plants in 2008 out of an estimated 189,000 in operation at the time.

Under the Food Safety & Modernization Act signed into law earlier this year, the Food & Drug Administration is expected to inspect some 19,200 foreign food facilities by 2016. That lofty goal is “almost certainly unattainable considering budgetary limitations,” according to Robert Hahn, an attorney for OFW Law speaking at the latest Food Institute webinar on the FSMA – part of the association’s ongoing series. To give you an idea of how “lofty” that goal is, FDA inspected just 153 foreign plants in 2008 out of an estimated 189,000 in operation at the time.

That does not mean that FDA will not make every effort to substantially increase inspections of those foreign facilities noted Mr. Hahn. 
Third party auditors are certain to play a large role in this process as it evolves. Those auditors will be relied upon to inspect many international facilities considering FDA’s benchmarks over the next five years. The details about how third party auditors will operate will be the topic of much conversation and discussion within the government and the global food industry. As noted at the webinar, FDA will likely hold a meeting on the topic over the next few months to iron out some of those details and listen to industry comments.  The Food Institute will be reporting on these developments as the implementation of the FSMA progresses and will discuss them in future webinars as the series progresses.

Mr,. Hahn also anticipates FDA will schedule a meeting addressing the accreditation process for third party auditors in coming months.
For the time being, FDA is currently in “thinking and drafting mode,” in this process. Thus far, the agency has issued two interim final rules, on administrative detention and prior notice, updated the Fish and Fishery Products Hazards Analysis and Controls Guidance, and created a consumer-friendly search engine for recalls. Furthermore, FDA has been accepting comments from the industry on numerous aspects from FDA’s new manadaory recall authority to improving the reportable food registry.

During a public meeting FDA held last month, a significant amount of attention was directed to the agency’s enforcement of reportable foods, and the responsibility of grocery stores to safeguard consumers from purchasing such foods. The agency has discretionary authority to require consumer notification of “reportable foods,” and if a report is made to the Reportable Food Registry, FDA may require the responsible party to submit “consumer-oriented information” to the agency, which will then post a one page summary on its website. Any grocery store that sold the reportable food and is part of chain with 15 or more locations must provide notification to consumers within 24 hours and maintain the notification for 14 days. The manner and location of the notification will be determined by FDA within one year.

The issue of the regulation focused on the definition of a grocery store. Most attendees at the meeting claimed that the definition should apply to a wide variety of retailers, and methods of notification that were considered were printouts at cash registers, video kiosks and phone/text/email messages to consumers enrolled in loyalty card programs.

In a relatively short time, FDA has been extremely busy looking to be on target with implementing the FSMA within the mandated timeframes, notes The Food Institute. Numerous developments can be anticipated over the next year and will be covered in the Institute’s ongoing webinar series as well summarized in The Food Institute Report.

If you would like to learn more, simply go to www.foodinstitute.com/FSMAwebinar.cfm