On Jan. 10, 2012, a Congressional House report was issued on the government’s investigation into the cantaloupe Listeria outbreak. The report provided some very interesting findings and lessons not only for and about Jensen Farms but for and about the industry as a whole.
Conducted by the Congressional Committee on Energy and Commerce, the investigation included a review of documents from and interviews with FDA; Jensen Farms; its distributor, Frontera Produce; and its third-party auditor, Primus Labs. And it was the information obtained from and about the audits that was highlighted as of most significant issue – and concern – in the report. The report was accompanied by a Letter from the Committee to FDA Commissioner Margaret Hamburg that further emphasized concern around the use of third-party auditors. The letter to Commissioner Hamburg stated:
“We urge you to review closely the information uncovered during our investigation. In particular, the investigation identified significant problems with the third-party inspection system used by growers and distributors … FDA officials identified “serious design flaws” in the processing technique used at Jensen Farms and “poor sanitary design of the facility itself” as the causes of the contamination, and they indicated that “everything that was found wrong was addressed in FDA guidance” published in 2009. Yet these flawed facility designs and processing techniques were both recommended by and rated as “superior” by the third-party auditor of Jensen Farms.
This finding revealed two major industry problem areas:
1. Failures in the industry’s auditing system
As the letter states “The auditing failed in the case of the recent Listeria outbreak.” These failures are itemized as the auditors:
– missing or failing to prioritize important food safety deficiencies
– lacking any regulatory authority and not reporting identified problems to any regulatory authority
– not ensuring that identified problems were resolved
– providing advance notice of site visits
– spending only a short period of time on-site
– multiple conflicts of interest
In defense, Jerry Walzel, the president of Bio Food Safety, Inc., the subcontractor hired by Primus Labs to conduct the Jensen Farms audit, stated that consistent with Primus Labs policy – the audits only deducted from the score if a method or technique was inconsistent with FDA regulations; they did not deduct from the score if FDA guidance was not being followed – which brings up the second major issue.
2. The perception of guidance vs. regulation
The auditors’ findings were not based on the practices of the best farms and failed to ensure that the producer met FDA guidance.
I don’t believe that Walzel’s additional statement that “guidelines are opinions … regulations are law” is indicative of the perception and practices followed by the industry and/or its auditors. But if that is a view, the consequence will herald the end of self-policing and ensure that all GMPs and guidance documents become regulation.
The issue of what to do about FDA guidance vs. regulations is not new. The fact that “one does not have to follow guidance” is true in a literal sense. But from a practical perspective, any company that does not follow FDA guidance is, quite frankly, looking for trouble. In fact, whether or not this is indicative of majority perception, the fact remains that it was unfortunately stated as defense in an outbreak that sickened 146 people in 28 states, killed 30, and caused a miscarriage; that an official of a leading auditing agency told the committee that his company “did not consider FDA guidance when conducting audits;” and that a processor with “serious design flaws” passed its audit with a 96 percent and no deficiencies noted or corrective action stated. Aside from the human tragedy associated with this outbreak, this report and the accompanying letter are another black eye for third-party audit systems. This is a sad reflection of a system that has much to add to food safety and public health. If not to assure food safety, what is the purpose of third-party audits on which so much of the industry depends?
Additionally, each of the Jensen Farm or third-party audit failures noted by the committee raises further question, the answers of which will impact the entire industry. For example, in noting the auditors’ failure to report problems to regulatory authorities, the question to be asked is – If you are in a food plant and see an obvious Class I hazard, do you have an obligation to report it? Although FSMA Section 307, Accreditation of Third-Party Auditors, states that the results of a regulatory third-party audit are to determine if the facility can be certified, while the results of a consultative audit “are for internal purposes only,” does the consultative auditor still hold a legal responsibility to report Class I hazards to FDA? This is a question to which there does not yet appear to be a clear answer, but has wide ranging implications if the answer is “yes.”
It is through FSMA that Congress expects FDA to fix these failures. As the letter explains, FSMA requires that FDA establish an accreditation system and model auditing standards for third-party audits of imported foods. However, the standards are expected to influence domestic audits as well, and the committee suggested that “FDA consider developing a voluntary model program for domestic auditors that could become the standard of care for third-party auditing programs in the United States.”
We have to hope that the details will be clearly and comprehensively specified when the regulatory language of the section is published. And we should all hope that, for the sake of the food industry and the consumer, that the setting of robust standards for these foreign audits – and auditors, will put third-party audits in a good light and not become a source of constant criticism and doubt. There are already some robust third-party audit programs, but those who are looking for problems don’t differentiate the good from the bad, and thus Congressional focus, such as happened recently, is nothing but damaging to a system that has great capacity to protect both brands and public health.
Dr. David Acheson, former FDA Associate Commission for Foods, is Managing Director for Food and Import Safety at Leavitt Partners LLC. ” Investigation of Cantaloupe Listeria Outbreak Has Congress Asking Serious Questions Around Third Party Audits” first appeared on the Leavitt Partners blog Jan. 19, 2012.