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Food Safety News

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Top Food Safety Stories of 2010: No. 8

Number 8 in our list of the top 17 food safety news stories of 2010 is the frequency–or infrequency–of food inspections in the United States.

The headlines said it all last April–”Except for Meat Most Food Does Not Get Inspected.”   Ordinarily it would not have been good news for the U.S. Food and Drug Administration (FDA), the agency responsible for inspecting the 80 percent of U.S. food that is not meat.

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Coming last April, however, when the Senate was still months away from acting on the FDA Food Safety and Modernization Act, it delivered the unwashed truth exactly when it was needed.

FDA got an assist from the Inspector General’s Office at the Department of Health and Human Services.  FDA not only agreed with the Inspector General’s findings, the agency pretty much agreed with its recommendations.

Among the major findings were:

  • On average, FDA inspects less than one quarter of the food facilities each year, and the number of facilities inspected has declined over time.  

  • Fifty-six percent of food facilities have gone five or more years without an FDA inspection.

  • The number of facilities that received official action indicated (OIA) classifications have declined over time.

  • FDA took regulatory action against 46 percent of the facilities with initial OAI classifications; for the remainder, FDA either lowered the classification or took no regulatory action.

  • For 36 percent of the facilities with OAI classifications in fiscal year (FY) 2007, FDA took no additional steps to ensure that the violations were corrected.

USDA’s Food Safety & Inspection Service (FSIS) assigns resident inspectors to all beef, pork, poultry and egg production facilities.  Inspectors are on the scene at those facilities during operations.  It takes about 6,500 inspectors to cover those USDA-inspected facilities.

By contrast, FDA in FY 2010 had no more than 2,505 inspectors to cover 51,229 food facilities that fall under its regulatory authority.   More than half of those facilities have not been inspected in more than five years.  ”If FDA does not routinely inspect food facilities, it is unable to guarantee that these facilities are complying with applicable laws and regulations,” the IG said.

FDA has managed to obtain budget authority to hire and train 339 additional inspectors since FT 2009, but, by some estimates, will need a couple thousand more to do the job set out in S. 510, the FDA Food Safety and Modernization Act.

As it is, the IG found that the number of food plants getting inspected by FDA’s Food Program field team is going down, and the number of facilities is going up.  The most food inspections in the five-year period covered by the IG report occurred during 2004 when 17,032 inspections were completed.

In the most recent year covered by the report, 2008, less than 15,000 facilities were inspected.  And the food industry is either cleaning up its act or inspectors are inflating the grades they are giving because the number of plants tagged for OIA has been cut in half.

The IG found that food makers coming to OIA attention typically fall into one or more of these categories: unsafe practices or insanitary conditions; repeat offender, and/or refuse to open records to inspection.  The IG also found enforcement action against just two percent.

The April IG report also made several recommendations, including for FDA to make more frequent inspections with emphasis on high-risk facilities.  The IG also made suggestions for improving on how OAI cases are handled, calling for FDA authority to impose civil penalties and access records during inspection.

The thrust of what the IG recommended is now covered in the food safety bill awaiting the President’s signature.

© Food Safety News
  • http://www.healthyfoodcoalition.org hhamil

    The article states, “By contrast, FDA in FY 2010 had no more than 2,505 inspectors to cover 51,229 food facilities that fall under its regulatory authority.”
    What is the source of the “51,229″ figure?
    According to the FDA (http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/ucm175995.htm), “As of July 15, 2009, FDA had received 382,866 registrations, of which 226,373 are foreign facilities and 156,493 are domestic facilities.” Which ones are free from inspection? Dr. Hamburg’s 10-22-09 written testimony to the Senate HELP Committee addressed the issue of foreign facilities and estimated the number at approximately 230,000. She stated the FDA would rely on inspection by its counterparts in other countries and desired language in the FSMA authorizing the use of accredited third party inspectors.
    The articles states, “FDA has managed to obtain budget authority to hire and train 339 additional inspectors since FT 2009, but, by some estimates, will need a couple thousand more to do the job set out in S. 510, the FDA Food Safety and Modernization Act.”
    I suggest that you listen to FDA Commissioner Hamburg’s actual testimony (not her submitted written comments) to the Senate HELP Committee on 10-22-09. As I recall, she estimated only a very small number of facilities inspected per inspector. In addition, I suggest you review the GAO report for numbers of actual inspections made.
    Unless the FDA becomes astonishingly more efficient, the number of inspectors needed will be extraordinary. The clear underestimation of this cost by the CBO got almost no comment.
    In addition, you make no mention of the number of inspectors needed to assure compliance with the new Sec. 419 Standards for Produce Safety of the FFDCA created by the FSMA.
    Will the failure of the advocates for the FSMA to accurately estimate its cost be a top story of 2010?

  • danflynn

    Harry, the number 51,229 comes from the IG report. It supposedly includes “food facilities that were subject to inspection and in business from the start of FY 2004 until the end of FY 2008.” And the IG report covered only domestic food facilities.
    Just using round figures, about 2,500 FDA staff are inspecting about 15,000 facilities a year, or about six per employee. Inspections often involve teams being in the facility for days or weeks. But six is a number FDA might have a hard time explaining to the incoming Congress.

  • http://www.healthyfoodcoalition.org Harry Hamil

    The article states, “By contrast, FDA in FY 2010 had no more than 2,505 inspectors to cover 51,229 food facilities that fall under its regulatory authority.”
    What is the source of the “51,229″ figure?
    According to the FDA (http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/ucm175995.htm), “As of July 15, 2009, FDA had received 382,866 registrations, of which 226,373 are foreign facilities and 156,493 are domestic facilities.” Which ones are free from inspection? Dr. Hamburg’s 10-22-09 written testimony to the Senate HELP Committee addressed the issue of foreign facilities and estimated the number at approximately 230,000. She stated the FDA would rely on inspection by its counterparts in other countries and desired language in the FSMA authorizing the use of accredited third party inspectors.
    The articles states, “FDA has managed to obtain budget authority to hire and train 339 additional inspectors since FT 2009, but, by some estimates, will need a couple thousand more to do the job set out in S. 510, the FDA Food Safety and Modernization Act.”
    I suggest that you listen to FDA Commissioner Hamburg’s actual testimony (not her submitted written comments) to the Senate HELP Committee on 10-22-09. As I recall, she estimated only a very small number of facilities inspected per inspector. In addition, I suggest you review the GAO report for numbers of actual inspections made.
    Unless the FDA becomes astonishingly more efficient, the number of inspectors needed will be extraordinary. The clear underestimation of this cost by the CBO got almost no comment.
    In addition, you make no mention of the number of inspectors needed to assure compliance with the new Sec. 419 Standards for Produce Safety of the FFDCA created by the FSMA.
    Will the failure of the advocates for the FSMA to accurately estimate its cost be a top story of 2010?

  • Dan Flynn

    Harry, the number 51,229 comes from the IG report. It supposedly includes “food facilities that were subject to inspection and in business from the start of FY 2004 until the end of FY 2008.” And the IG report covered only domestic food facilities.
    Just using round figures, about 2,500 FDA staff are inspecting about 15,000 facilities a year, or about six per employee. Inspections often involve teams being in the facility for days or weeks. But six is a number FDA might have a hard time explaining to the incoming Congress.