Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Food

Agencies are able to receive shipment time-of-arrival information from ACE.

CBP reported that it has tested and implemented time-of-arrival information in its existing screening system, the Automated Commercial System. (CBP's new system, called the Automated Commercial Environment, will not be operational until October 15, 2011). Furthermore, CBP has explored the possibility of implementing a similar agreement with FSIS, and FSIS has a plan for pulling time-of-arrival information from ACE into the FSIS's import screening system.

FDA has worked with Congress to include civil penalty authority in food safety legislation, and the House of Representatives passed this bill. Section 135 of H.R. 2749, the Food Safety Enhancement Act, which was passed by the House of Representatives on July 30, 2009, would establish civil monetary penalties that FDA would be able to impose for violations relating to food. The Administration has issued a Statement of Administration Position in support of H.R. 2749.

Section 135 of H.R. 2749, the Food Safety Enhancement Act, which was passed by the House of Representatives on July 30, 2009, would establish civil monetary penalties that FDA would be able to impose for violations relating to food.

On March 7, 2012, CBP sent documentation indicating that a Participating Government Agency (PGA) Message Set had been developed for ACE that will allow for the capture of unique identifiers required by participating government agencies. (CBP further indicated that while FDA has not yet selected the specific unique identifier for foreign firms, the message set is flexible enough to adapt to their decision when it is made.)

In March 2012, CBP sent documentation indicating that a program had been developed for ACE that will allow for the capture of unique identifiers required by participating government agencies. (Although FDA has not yet selected the specific unique identifier for foreign firms, the message set is flexible enough to adapt to their decision.) Moreover, the FDA Food Safety Modernization Act included a provision stating that, not later than 1 year after the date of enactment of the Act, the Secretary, acting through the Commissioner of Food and Drugs, shall conduct a study regarding the need for, and challenges associated with, development and implementation of a program that requires a unique identification number for each food facility registered with the Secretary and, as appropriate, each broker that imports food into the United States. Because FDA worked with Congress to include this authority in the legislation, this recommendation is closed.

FDA said it believes that continuing to engage with CBP to develop a joint refusal/redelivery process is important. CBP and FDA have begun discussions of the joint form, as a prerequisite to consider this joint notice as a national procedure. Additional discussions are needed to complete this evaluation, after which it may be that national procedures can be drafted, cleared, and implemented. According to CBP, moreover, FDA determined that it would conduct an internal survey of the procedures currently being used when issuing refusals. CBP received the results of the FDA survey on 6/28/10.

CBP and FDA conducted the recommended study to determine the current refusal/re-delivery process. CBP conducted an internal survey requesting copies of the local Standard Operating Procedures being utilized to develop a national policy. Based on the findings from that internal survey, CBP drafted national procedures to implement a joint refusal/re-delivery process.

To further the advancements already in progress regarding information technology (IT) projects, FDA told us that it has initiated a project through the Partnership for Food Protection to further enhance IT integration through the augmentation of the functionality of eLEXNET, an internet-based data exchange system that allows Federal, State and local laboratories to electronically share food safety sample and test data for various foodborne pathogens. While this project is in the earliest stages of development, it initiates the process of providing a global repository of test data for FDA. The 2011 enhancements to eSAF include the ability to collect recall audit check data from state partners and the collection of data to support Field Management Directive (FMD) 76 and Manufactured Food Regulatory Program Standards (MFRPS) inspection auditing requirements. FDA has also implemented a process to utilize state analytical data to support the issuance of import alerts. If a state collects an imported sample as part of routine inspection or surveillance work and determines that the sample is violative, FDA can use those data to support import alerts. In addition, FDA stated that five state agencies, through the food contract, currently participate in a program to review and/or sample imported commodities during the course of routine contract work.

In FY10, FDA began distributing its weekly operational report as well as Reportable Food Registry (RFR) submissions with commissioned state officials to improve federal-state response to food and feed safety incidents. FDA also maintains support for changes to existing law to strengthen the ability of the agency to share information with states.

In August 2013, FDA sent its PREDICT Process Evaluation Plan, which evaluates performance in four key areas: (1) Rules Management, (2) Entry Review, (3) Examination and Sampling, and (4) Communication. FDA began the evaluation of PREDICT based on the written evaluation plan in late FY 2012 and expects to complete it in FY 2013.