FDA Official Discusses New Joint Refusal-Redelivery Form, Etc. at Food Safety Hearing

Among other things, Taylor discussed FDA’s response to a 2009 Government Accountability Office report that was critical of FDA’s oversight of imported food. Taylor also praised many aspects of the House-passed food safety bill, H.R. 2749.

FDA Addressing GAO Criticism by Improving Collaboration with CBP, Etc

According to Taylor, FDA acknowledges that GAO raised some important issues in its September 2009 report on imported food and will incorporate many of GAO’s recommendations. [See ITT’s Online Archives or 10/19/09 news, (Ref: 09101915), for BP summary of the GAO report.]

He stated that FDA is already taking the following steps to improve its oversight of the safety of imported food:

Working on joint FDA refusal - CBP redelivery form. As recommended, FDA is working with U.S. Customs and Border Protection to develop a national procedure and implement a joint FDA Refusal and CBP Re-delivery form. If approved, the joint notice should:

• Improve importer compliance with FDA refusal procedures;
• Help ensure that violative products are exported or destroyed; and
• Expedite the response time for the entry refusal process.

Devising plan to evaluate PREDICT. FDA agrees with GAO that a performance measurement plan is key to successfully evaluating FDA's upcoming Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system and is developing a plan to assess whether PREDICT improves FDA’s screening of import shipments, provides FDA with better information for decision-making purposes, improves upon the current screening module (OASIS), etc.

The official notes, however, that the plan cannot be fully implemented until PREDICT has been in use nationwide for a sufficient period of time to allow the necessary data to be generated, and that PREDICT’s full deployment has been delayed due to technical problems. [See ITT’s Online Archives or 04/20/10 news, (Ref: 10042017), for BP summary of the indefinite suspension of further rollout of PREDICT.]

Better risk-based targeting in sampling, etc. In addition, FDA is continuing to develop a risk-informed process to better target its food safety inspections, sampling, and laboratory analysis of food products. In fiscal years (FY) 2008 and 2009, FDA used a risk-informed model to prioritize which food manufacturers it should inspect. The model considered such factors as association of specific food industry types with foodborne outbreaks, recalls and/or reports of serious adverse events, the inherent risk of food products, and the compliance risk of facilities, as determined by past inspection histories. Taylor states that the application of this model has continued in FY 2010.

Agrees with House Bill’s Approach on Inspections, Imports, Penalties, Etc

Taylor also agreed with and praised a number of aspects of House-passed H.R. 2749, the Food Safety Enhancement Act of 2009, including the shift in focus of inspections to prevention rather than collecting evidence after problems have occurred; its new tools for ensuring that importers reliably verify that the foods they import are in compliance with standards equivalent to those in the U.S.; the ability to impose civil monetary penalties; and the new authority to require annual registration and unique identifiers for food facilities.

[The Senate is expected to soon begin its consideration of S. 510, the FDA Food Safety Modernization Act. See ITT’s Online Archives or 04/14/10 news, (Ref: 10041405), for BP summary.

See ITT’s Online Archives or 09/01/09, 08/25/09, 08/12/09, 08/10/09 and 08/04/09 news, (Ref: 09090120), (Ref: 09082510), (Ref: 09081205), (Ref: 09081015) and (Ref: 09080415), for BP summaries of House-passed H.R. 2749’s provisions on: ceramicware, Bisphenol A, & infant formula; facilities and exporting; food tracing; broker registration and new reasons to detain food; and importer registration, certification for high-risk imports, and increased inspections.]

¹The House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations

House subcommittee hearing information available at http://energycommerce.house.gov/index.php?option=com_content&view=article&id=1994:the-role-and-performance-of-fda-in-ensuring-food-safety&catid=133:subcommittee-on-oversight-and-investigations&Itemid=73