FDA: Unclear How Much It Will Cost to Conduct Inspections to meet FSMA Requirements

Michael Taylor, Deputy Commissioner for Foods, the public official charged with leading the implementation of the monumental FDA Food Safety Modernization Act, wrote a letter this week to provide an update on the agency’s progress. According to Taylor, FDA has met a few key deadlines but has a lot of ground to cover.

In his Dear Colleague letter, Taylor outlined recent accomplishments at FDA, including a new “consumer friendly” recall search engine, which was created in consultation with “numerous stakeholder groups.”

He also pointed to FDA’s annual report to Congress, which was submitted last month. According to the report, FDA still doesn’t have a grasp of just how much it would cost to inspect high-risk facilities as the federal regulators are directed to do under the new food safety law.

The report notes that data from the cost of inspection from past years “were not structured to correspond” to the new framework required by the law. “Information on this point will be provided in future annual reports as it becomes available.”

”It should be noted that the risk level is only one element of many that affects the cost of doing an inspection” continues the update. “Other factors include the size of the facility both in number of people and square footage of the facility, the complexity or level of automation of the manufacturing process, and the volume of products, both in terms of the quantity produced and the number of different types of products produced, just to name a few. Whether a facility is characterized as high or low risk does not alone determine the cost of inspection.”

FDA also provided an update on the number of facilities under the agency’s jurisdiction.

“As of January 13, 2011, there were 167,033 active registered domestic facilities and 254,088 active registered foreign facilities, for a total of 421,121,” the report states. “In FY 2010, FDA and the States under contract with FDA inspected 25,214 domestic food facilities and 357 foreign food facilities.”

FDA also reported that in FY 2010 the agency inspected 206,723 food import lines, which amounts to approximately 2.1 percent of all food import lines.

The report ends with an overview of FDA’s growing number of foreign offices. There are 13 posts total now, in China, India, Costa Rica, Mexico, Belgium, the UK and Italy. The agency notes that collaborations between state, local, international, and federal agencies are expected to be strengthened in the coming months.

In his update letter, Taylor also highlighted a few recent FSMA deadlines met:

— FDA released the 4th edition of the “Fish and Fishery Products Hazards and Controls Guidance.”  It contains FDA’s latest recommendations to the seafood industry for reducing and eliminating food safety hazards in the fish and fishery products they process.

— FDA issued an interim final rule that requires anyone importing food into the United States to inform FDA if any country has refused entry to the same product, including food for animals. This new requirement will provide the agency with more information about foods that are being imported, which improves the FDA’s ability to target foods that may pose a significant risk to public health.

— FDA released an interim final rule on administrative detention of food, which allows the FDA to administratively detain food the agency believes has been produced under unsanitary or unsafe conditions.  Previously, the agency’s ability to detain food products applied only when the agency had credible evidence that a food product presented was contaminated or mislabeled in a way that presented a threat of serious adverse health consequences or death to humans or animals.

A copy of the letter is available on FDA’s website here.