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FDA Issues Annual Report on Food Facilities, Imports and Foreign Offices

Wednesday, November 27, 2013
Sandler, Travis & Rosenberg Trade Report

As required by the Food Safety Modernization Act, the Food and Drug Administration recently issued its third annual report on food facilities, food imports and FDA foreign offices. The report covers such matters as the appropriations used to inspect facilities registered pursuant to section 415 of the Federal, Food, Drug, and Cosmetic Act, the average cost of both a non-high-risk and a high-risk food facility inspection, the number of domestic and foreign facilities registered pursuant to section 415 of the FD&C Act that the FDA inspected in the previous fiscal year, the number of domestic and foreign facilities that were scheduled for inspection in the previous fiscal year but were ultimately not inspected, and the number of high-risk facilities identified pursuant to section 421 of the FD&C Act that were inspected as well as the number that were scheduled for inspection but were not inspected.

Required information about food imports includes the number of lines of food imported into the U.S. that the FDA physically inspected or sampled in the previous fiscal year, the number of lines of food imported into the U.S. that were not physically inspected or sampled in the previous fiscal year, and the average cost of physically inspecting or sampling a line of food subject to the FD&C Act that is imported or offered for import into the U.S. Lastly, the report includes information on the number of foreign FDA offices as well as the personnel stationed in each office.

The report indicates that the FDA physically examined (conducted field exams or analyzed samples) only 1.9%, or 207,839, of all food and feed import lines in fiscal year 2012. However, the FDA did electronically screen all import entries using an automated system that helps field inspectors determine which products pose the greatest risk. The agency recently enhanced its screening capability by implementing the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) information technology system. PREDICT uses data analytics from the entire life cycle of a product to better identify and target high-risk products before they enter the country. In addition, when necessary the FDA can issue import bulletins that signal FDA inspectors to pay special attention to a particular product, or a range of products from a particular producer, shipper or importer. Under import alerts products that appear to be subject to refusal based on existing evidence (such as a history of violations) can be detained at the border and refused admission into U.S. commerce unless the importer is able to demonstrate that the products are in compliance.

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