With FSMA in Mind, GAO Reviews FDA’s Overseas Offices

FDA needs to adequately staff its foreign offices – where 44 percent of positions were vacant as of October 2014 — to fulfill its inspection mandate under the Food Safety Modernization Act (FSMA), according to a newly released report by the Government Accountability Office (GAO).

Under FSMA, FDA was mandated to inspect at least 600 foreign food facilities in 2011 and, for each of the next five years, to inspect at least twice the number of facilities inspected during the previous year. However, GAO explains, the agency is not currently keeping pace with that FSMA requirement. FDA officials told GAO’s researchers they do not plan to meet the FSMA mandate because of funding. The officials also “questioned the usefulness of conducting that many inspections,” GAO says.

GAO conducted an in-depth review of FDA’s foreign office operations in Canada, China, and Mexico. The locations were selected based on an analysis of the volume of food imports, the percentage of food imports refused at the border, and the number of food facility inspections for fiscal year 2013, among other factors. The review included visits to FDA’s offices in Beijing and Guangzhou, China, and in Mexico City.

This is not the first time GAO has looked into FDA’s overseas staffing. In 2010, the oversight arm of the U.S. Congress recommended that FDA develop a strategic workforce plan for its foreign offices to help ensure it recruits staff with the necessary experience and skills. “GAO continues to believe that such a plan for the foreign offices is critical to FDA’s ability to address staffing challenges,” the new report states.

“FDA has not conducted an analysis to determine whether the number of inspections in the FSMA mandate or the lower number of inspections it is conducting is sufficient to ensure comparable safety of imported and domestic food. Without such an analysis, FDA is not in a position to know what is a sufficient number of foreign inspections and, if appropriate, request a change in the mandate,” GAO says.

I believe it would be very helpful to fully staff all FDA overseas offices. But as a practical matter, I also believe direct inspection by FDA of overseas food facilities is not the key to improving the safety of food imported into the United States. Certified third party audits, the Foreign Supplier Verification Program, along with outreach and education efforts to stakeholders are likely to play a far more important role. As final regulations begin to roll out this year, FDA’s overseas offices will have their hands full simply explaining those new regulations.

Lessons Learned from the Implementation of Seafood HACCP for FSMA

One of the tenets of FSMA is the requirement for preventive systems (AKA HACCP) for all food groups regulated by FDA. Up to the time of passage of FSMA, FDA wanted preventive systems only for seafood, fruit and vegetable juices and low-acid canned foods. Since the requirement for preventive systems is about to be extended to all foods regulated by FDA it may be instructive for affected food firms to consider some of the common problems experienced by the seafood industry during the implementation of HACCP. This regulation has been highly successful and truly promoted seafood safety and consumer confidence in these products. There are several useful lessons that may make your transition to compliance easier.

  1. Unnecessary CCP’s. Implementation of the Seafood HACCP regulation came with a great deal of uncertainty for the industry.   Their response was to include a hazard as a CCP even when it did not meet the FDA “reasonably likely to occur” standard. This resulted in some cases overly complicated HACCP plans.   Firms can avoid this problem through rigorous hazard analysis and following agency guidance for the commodity being processed.
  1. Mixing sanitation controls with HACCP controls.The Seafood HACCP Regulation requires that certain aspects of sanitation be properly controlled, monitored and documented through records. While it is feasible to include these controls within the HACCP plan it is much simpler keep sanitation controls separate from HACCP controls.   A sanitation SOP is highly recommended that show how sanitation is controlled, monitored and recorded.
  1. Monitoring need to be available in their original form in an organized fashion.Inadequate or poorly organized monitoring records were a big problem. Ideally, records should not be rewritten unless absolutely necessary. Rewritten records are a red flag to FDA investigators.   If records are missing do not falsify information to fill the gaps. This could be the basis for a severe regulatory action. It is much better to perform a verification review and corrective action that is available to the investigator.
  1. If a new product is introduced to your processing operation the HACCP plan should be amended immediately.Do not wait until a convenient time as a regulator could show up at any time. Also, do not assume that the hazard analysis and HACCP plan for a similar product will be the same.   Either can result in a finding of failure to have a HACCP plan. You should start at the beginning with a proper hazard analysis and develop the plan for that product in accordance with the hazards you identify.
  1. Scientific studies used to establish a critical limit for a CCP should be readily available to the investigator.For example, a study to show the necessary heat penetration time-temperature parameters of a cooked product to achieve sufficient bacterial kill or the proper mix of salt, water and exposure time to achieve a proper level of water phase salts in a cold smoked fish products are important information for the investigator to evaluate whether the critical limit of a CCP is adequate to control the hazard.
  1. Generic HACCP plans should not be used.In the past some operations adopted a generic HACCP plan to cover their processing without performing a hazard analysis.   This often resulted in hazards being missed and a faulty plan. FDA expects that each firm will conduct a hazard analysis.   Not doing so could result in a serious charge.