Harkin: New Report Reinforces Need to Pass Comprehensive Food Safety Reform Now

WASHINGTON, D.C. – Senator Tom Harkin (D-IA) released the following statement today regarding a Department of Health and Human Services (HHS) Office of the Inspector General (OIG) report on the Food and Drug Administration’s (FDA) inspections of domestic food facilities.  Among its findings, the report identifies significant weaknesses in FDA’s inspections of food facilities, including the fact that FDA inspects less than a quarter of food facilities each year, and that more than half of all food facilities have gone five or more years without an FDA inspection.  Harkin initially requested this report as Chairman of the Senate Committee on Agriculture, Nutrition and Forestry.  The Senate Health, Education, Labor and Pensions (HELP) Committee, which Harkin now chairs, reported out the FDA Food Modernization Act of 2009 without a single dissenting vote on November 18, 2009.  It must now go to the full Senate to be approved.

“This new report shows what we have feared for too long: that that our domestic food facilities are not being adequately inspected and FDA needs additional authorities to keep the food on our tables safe.  This is unacceptable in our modern society and an important reminder that we must provide FDA with the needed tools to properly inspect food facilities and effectively react to problems in order to ensure the safety of the food American families eat.  Quite simply, picking up food at the grocery store should not be a health risk.

“At a time when party line bickering seems to have reached an all time high, efforts to pass comprehensive food safety legislation have risen above partisanship.  In fact, our food safety bill passed out of the Senate HELP Committee without a single ‘no’ vote and a similar bill passed in the House with strong bipartisan support.  This legislation is long overdue and it is my hope that we can soon pass the FDA Food Modernization Act of 2009 on the Senate floor in order to get the bill reconciled with the House and on the President’s desk to be signed into law.”

A summary of the report as provided by the HHS OIG can be found below.  A full copy of the report can be found here.

FDA Inspections of Domestic Food Facilities (OEI-02-08-00080)

Our report identifies significant weaknesses in FDA’s inspections of food facilities.  FDA inspects food facilities to ensure food safety and compliance with regulations.  Our report finds that FDA inspects less than a quarter of food facilities each year.  In addition, more than half of all food facilities have gone five or more years without an FDA inspection.  Further, when FDA identifies violations that are significant enough to warrant an “official action indicated” (OAI) classification, some type of regulatory action should be recommended.  This action could include issuing a warning letter, holding a regulatory meeting, or initiating an enforcement action such as a seizure or an injunction.  In fiscal year 2007, FDA took action against 46 percent of the facilities that initially received OAI classifications.  FDA either lowered the classification or took no regulatory action for the remaining facilities.  We also found that most of the facilities that received OAI classifications had a history of violations and that some facilities refused to grant FDA access to their records.

Finally, for 36 percent of the facilities that received OAI classifications, FDA took no additional steps to ensure that the violations were corrected.  For the remaining facilities, FDA either re-inspected the facilities or reviewed some type of evidence from the facility that demonstrated that the facility had corrected violations.

Based on the findings of this report, we recommended that FDA: (1) increase the frequency of food facility inspections, with particular emphasis on high-risk facilities; (2) provide additional guidance about when it is appropriate to lower OAI classifications; (3) take appropriate actions against facilities with OAI classifications, particularly those that have histories of violations; (4) ensure that violations are corrected for all facilities that receive OAI classifications; (5) consider seeking additional statutory authority that would allow FDA to impose civil penalties through administrative proceedings; and (6) seek statutory authority to allow FDA access to facilities’ records during the inspection process.  FDA supported our two recommendations to seek additional statutory authority and agreed with our recommendation to provide additional guidance about when it is appropriate to lower OAI classifications.  FDA noted several actions it has taken, or plans to take, to address the remaining three recommendations.