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Democrats Urge FDA to Reform Third-Party Auditing System

Democrats on the Energy and Commerce Committee are flagging problems with third-party inspections, which many growers and retailers rely on for food safety oversight, and urging federal officials to reform the audit system.

Lawmakers sent a letter to Food and Drug Administration Commissioner Margaret Hamburg Tuesday citing the “significant problems” the panel found during its investigation of the multi-state cantaloupe listeria outbreak, the deadliest foodborne illness outbreak in 100 years.

“We urge you to review closely the information uncovered during our investigation,” read the letter, signed by Ranking Member Henry Waxman, D-CA; Dianna DeGette, D-CO; John Dingell, D-MI; and Frank Pallone, D-NJ.  “In particular, the investigation identified significant problems with the third-party inspection system used by growers and distributors to ensure the safety of fresh produce, This auditing system is often the first and only line of defense against a deadly food borne disease outbreak.”

In their investigation, Committee staff obtained documents from and interviewed “high-ranking officials” at FDA, Jensen Farms, the cantaloupe grower, Primus Labs, the third-party auditor that inspected Jensen right before the outbreak, and Frontera Produce, the distributor that shipped the cantaloupe across the country.

The staff report points out that though FDA officials identified serious problems and design flaws at Jensen Farms, the company was given a “superior” rating by Primus Labs just weeks before the outbreak began to grab national headlines.

“Our investigation reveals some of the reasons why: the auditors’ findings were not based on the practices of the best farms and failed to ensure that the producer met FDA guidance; the auditors missed or failed to prioritize important food safety deficiencies; the auditors lacked any regulatory authority and did not report identified problems to the FDA or other state or federal authorities; the auditors did not ensure that identified problems were resolved; and the auditors provided advance notice of site visits and spent only a short period of time on-site. It also became apparent in the investigation that the auditors had multiple conflicts of interest.”

The letter calls for FDA to develop a model program for domestic auditors “that could become the standard of care for third-party auditing programs in the United States.”

Lawmakers also called attention to the inherent conflict of interest issues with third party audits — the company that depends on a passing audit often gets to choose which company conducts the audit, which would contribute to certain company’s “extraordinarily high” pass rate. For Primus Labs, it was 97 percent.

“Indeed, the problems identified in the audits of Jensen Farms are similar to those that the Committee identified in food safety investigations in 2009 and 2010. In 2009, following the Salmonella outbreak in peanut butter products sold by the Peanut Corporation of America (PCA), a Committee investigation revealed that a private, for-profit auditing firm gave the company glowing reviews. The auditor, AlB, was selected by PCA, it was paid by PCA, and it reported to PCA. The auditor awarded a “superior” rating to the company’s plant. Six months after the audit, PCA’s products killed nine people and sickened 691 people.”

AIB also awarded Wright County Egg — the massive farm involved in a half-billion egg recall and Salmonella outbreak in 2010 — a “superior” rating and had awarded the company a “recognition of achievement.” Two months later, FDA reported a much different picture of “serious violations of food safety standards, including barns infested with mice, chicken manure piled eight feet high, and un-caged hens tracking through excrement,” according to the staff report.

“Like it or not our food safety system relies heavily on third-party auditors to identify dangerous practices and prevent contaminated foods from reaching the market,” concludes the letter. “We believe reforms in third-party audits are essential. We call on you to address the problems identified in this investigation in regulation and guidance.”

Read the full letter here.

© Food Safety News
  • Nal

    Like so much of our society, let’s find a scapegoat. Blame the auditors! Yes, I agree that third party auditing has its flaws. They provide only a snapshot of what happens at a facility. They generally are only going to see what a company wants them to see. They assess company practices (generally not process) against the audit standard. There are pressures from corporate offices and customers to make good scores. I am not an auditor, but sit on the other side of the table many times during the course of a year.
    The real culprit is the company. There are many good, reputable companies out there doing the right thing. They have knowledgeable people on board working to ensure that a safe and quality product is shipped. No one wants to make people sick, not to mention cause a death. Companies know – or should know – what is going on in their facilities.
    Third party audits, customer audits, trade associations, state and federal regulations, FDA are all used as sources to improve practices. It is a continuous process as new developments come into play. Every company must make a commitment to have the right people in place and to work on continuous improvement to ensure safety and quality.

  • I’m befuddled on this issue, admit that I’m old school, but the whole issue with “independent” 3rd party auditors has me shaking my head.
    First of all, we have meat & poultry plants which are required to have HACCP Plans in place, including GMP’s, SSOP’s, prerequisite programs, ad infinitum. Some of the company’s employees have received official HACCP training, which is in fact required to oversee daily operations. These folks are trained in Hazard Analyses, Prevention, CCP’s, microbial testing, and Corrective Actions to Prevent Recurrences amongst other duties. At the same time, plant operations are overseen by FSIS employees, and their multiple layers of supervisors and hq’s bureaucrats. FSIS employees have also been trained in HACCP methodology, coupled with agency training which allows them to capably scrutinize day-to-day meat production operations.
    Therefore, since we already have company employees and FSIS inspection personnel who not only have already received science-based training but are also “on the line” every day, why is there a need for allegedly independent, impartial and unbiased third party entities?
    Answers: (1) FSIS intentionally introduced HACCP as a tool for the agency to semi-retire at the largest meat establishments. Remember the agency’s promise that its role under HACCP would be “Hands Off”, that it would no longer police the industry, and that it would jettison its previous command-and-control authority. Well, since FSIS has no desire to intensive, hands-on oversight of the meat & poultry industry, well, quite frankly, we need a replacement set of “science-based” eyes to perform the oversight, absent a meaningful FSIS involvement. (2) HACCP has given plants the right to devise a production system which THEORETICALLY proves that the plant consistently produces safe food. Proof of plants’ success in this endeavor is provided via a plethora of daily HACCP reports, all done by company employees, and which can be easily falsified in the absence of any meaningful FSIS oversight. Since the fox is in charge of the henhouse (not only at Wright County Egg), and FSIS loathes intensive scrutiny anymore, quite frankly, public health interests are best promoted via trained, honest and impartial 3rd party entities. However, as this report shows, some of these auditors are apparently not trained, honest, or impartial. To be guilty of these 3 traits will result in no further assessments: what plant is willing to pay outside experts to reveal ongoing problems?
    Solution: FSIS must re-embrace its previous requirement to closely scrutinize meat production lines, with authority to implement aggressive enforcement actions when sanitation problems are solved. This however is contrary to the very heart of HACCP, which requires governmental non-involvement while the industry polices itself. Anyone who claims that America’s educational system is excellent will be forced to recount that belief, when we see how stupid Americans have been to endorse the HACCP protocol for RAW meat & poultry. I don’t care if we resort to subsequent 4th & 5th party auditors! As long as FSIS intentionally turns a blind eye to ongoing pathogen problems at slaughter plants, outbreaks will continue, and Congresx will be continually besieged to take positions on the efficacy of 3rd party assessments. Instead, Congress’ real focus should be on FSIS retirement at the largest meat establishments, by intentional agency design.
    Third party auditors should NOT be our focus here! Primary emphasis should instead be on the agency’s uptimate goal, which is COMFORT, a gift of FSIS-style HACCP.
    John Munsell

  • I’m befuddled on this issue, admit that I’m old school, but the whole issue with “independent” 3rd party auditors has me shaking my head.
    First of all, we have meat & poultry plants which are required to have HACCP Plans in place, including GMP’s, SSOP’s, prerequisite programs, ad infinitum. Some of the company’s employees have received official HACCP training, which is in fact required to oversee daily operations. These folks are trained in Hazard Analyses, Prevention, CCP’s, microbial testing, and Corrective Actions to Prevent Recurrences amongst other duties. At the same time, plant operations are overseen by FSIS employees, and their multiple layers of supervisors and hq’s bureaucrats. FSIS employees have also been trained in HACCP methodology, coupled with agency training which allows them to capably scrutinize day-to-day meat production operations.
    Therefore, since we already have company employees and FSIS inspection personnel who not only have already received science-based training but are also “on the line” every day, why is there a need for allegedly independent, impartial and unbiased third party entities?
    Answers: (1) FSIS intentionally introduced HACCP as a tool for the agency to semi-retire at the largest meat establishments. Remember the agency’s promise that its role under HACCP would be “Hands Off”, that it would no longer police the industry, and that it would jettison its previous command-and-control authority. Well, since FSIS has no desire to intensive, hands-on oversight of the meat & poultry industry, well, quite frankly, we need a replacement set of “science-based” eyes to perform the oversight, absent a meaningful FSIS involvement. (2) HACCP has given plants the right to devise a production system which THEORETICALLY proves that the plant consistently produces safe food. Proof of plants’ success in this endeavor is provided via a plethora of daily HACCP reports, all done by company employees, and which can be easily falsified in the absence of any meaningful FSIS oversight. Since the fox is in charge of the henhouse (not only at Wright County Egg), and FSIS loathes intensive scrutiny anymore, quite frankly, public health interests are best promoted via trained, honest and impartial 3rd party entities. However, as this report shows, some of these auditors are apparently not trained, honest, or impartial. To be guilty of these 3 traits will result in no further assessments: what plant is willing to pay outside experts to reveal ongoing problems?
    Solution: FSIS must re-embrace its previous requirement to closely scrutinize meat production lines, with authority to implement aggressive enforcement actions when sanitation problems are solved. This however is contrary to the very heart of HACCP, which requires governmental non-involvement while the industry polices itself. Anyone who claims that America’s educational system is excellent will be forced to recount that belief, when we see how stupid Americans have been to endorse the HACCP protocol for RAW meat & poultry. I don’t care if we resort to subsequent 4th & 5th party auditors! As long as FSIS intentionally turns a blind eye to ongoing pathogen problems at slaughter plants, outbreaks will continue, and Congresx will be continually besieged to take positions on the efficacy of 3rd party assessments. Instead, Congress’ real focus should be on FSIS retirement at the largest meat establishments, by intentional agency design.
    Third party auditors should NOT be our focus here! Primary emphasis should instead be on the agency’s uptimate goal, which is COMFORT, a gift of FSIS-style HACCP.
    John Munsell

  • Eric Gingerich

    It is easy to be a Monday morning quarterback after a problem has occurred and the errors are found. What is lacking is a standard set of criteria to go by. Does FDA provide this? No!! FDA is very good about saying you need to intervene to prevent problems but will not tell producers up front what needs to be done. The cantaloupe case here with Listeriosis is unprecedented. The proper control measures were not (and still are not) known completely. How can a good audit be constructed without the knowledge of what is required to prevent listeriosis being spread by melons.

  • What amuses me about the whole food safety debate and continuing food outbreaks, is that the food industry don’t seem to learn from previous mistakes. It is just like a continuing cycle of event / issue identified, media exposure, insufficient action, then back to the event. Research has found listeria associated with cantaloupe before and we know basic GMP when implemented controls many issues.

  • Reema

    It’s time to make FSIS bigger and police the operation of private sector (HACCP) along with biological investigations at more micro level. Suspend their permits and double up the re-permitting cost/s If plants fails to follow HACCP. I see this solution as a holistic approach to the known problem.