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Serious Questions About Third-Party Audits

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.

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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. 

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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.

© Food Safety News
  • doc raymond

    Good article that I think highlights two issues not often thought of when discussing third party audits and the FSMA.
    1. FDA uses GMPs and Guidances to try and make the products they have authority over safer. USDA uses rules and regulations. The difference is huge and is just one reason the two agencies should not be combined.
    2. FSMA and may food safety pundits emphasize the need to improve imported food safety, yet most of our outbreaks and illnesses are from domestic products. How can we expect to make Guatemala conform to our GMPs and guidances if we cannot make Jensen Farms conform?

  • http://www.twitter.com/H_O_G_ Joan

    I’m no longer able to trust any agency that follows up on the safety of our food. Why have auditors if they are able to be paid to look the other way.If it wasn’t a clear case of bribery, then it’s a case of failed auditing. Either way, it’s a lose-lose situation. It’s time for accountability. How may more lives must be lost? The blood of those that died is on the hands of ALL parties involved.

  • http://www.johnmunsell.com jmunsell

    FSIS “Guidance” documents are a source of confusion not only for the inspection force, but also for meat plant managers. Example: in March, 1998, FSIS issued a “Guidance for Beef Grinders to Better Protect Public Health”. This Guidance included 21 references to Traceback, Trace Forward, Trace Back, Trace, Tracking, Tracing, Tracking System, and Traceability. Subsequently, FSIS has displayed a cavalier ambivalence and refusal to perform tracebacks. Almost 14 years after FSIS published this Guidance document, the agency requested approval from OMB to perform Tracebacks subsequent to Verification Sampling Positives. If FDA issues Guidance documents, then ignores them as FSIS has the above Guidance for Grinders, we can assume FDA is not committed to the Guidance, and 3rd party auditors can play loose and easy with their review of plant practices. How can meat plants or produce companies be charged with noncompliance to Guidelines when the regulatory agency itself artfully dodges implementation of the Guideline? Indeed, compliance to Guidelines is voluntary. But if the Guidance is truly beneficial, it should morph into a regulation. Then, compliance with the regulation is required not only from the industry, but also by the regulatory agency.
    FSIS has always contended that Meat Plants’ HACCP Plans must say what they (meat plants) do, but the plant must then do what the HACCP Plan says. Same should be true for agency-released Guidance documents: agencies must proactively embrace and endorse what their guidance documents say.
    Public Health would benefit by FDA not following FSIS lead on this Guidance issue.
    John Munsell

  • Jess C. Rajan, Ph.D.

    Federal Agencies also use “third-party” audits in their operations. Both the FDA and FSIS use contracted services from a private entity for the accreditations and audits of federal food testing laboratories.
    Employees from the FDA and FSIS serve as “Liaisons” on the Board of Directors of the “third-party” contractor’s organization:
    http://www.a2la.org/committees/bodlist.cfm
    FSIS is conducting veterinary drug residue testing in animals used for human food under a 1984 Memorandum of Understanding (MOU) with the FDA. The standards and procedures used by FSIS and the private third-party for accreditations and audits are not based on U.S. food safety regulatory standards.

  • http://www.phfspec.com Peter Cocotas

    Some perspective. Third party audits were not designed to replace government inspections but partly to fill a void due to the lack of government inspections; nobody ever assumed that the results would be a substitute for a regulatory inspection nor that the results would be transmitted to a regulatory body. The purposes were to assess food safety systems in place and their effectiveness. They started out as a good idea and indeed performed a valuable service for buyers and sellers who in the absence of any material data could,for example, purchase food products from a factory in China with more confidence than sight unseen. But in truth the audit is a point in time; is only as good as the auditor; and a lot of audits have morphed from core food safety to quality systems resulting in a 100 page generic checklist without site specific expertise or hazard analysis.
    Accordingly, I don’t know whether it is more shocking or amusing to find that- after some fifteen or twenty years from their inception-that FDA now has concerns about these audits including that they “lacked regulatory authority” and that results were not reported to regulatory bodies. This begs more questions than answers because it implies that the audits were somehow involved or beholden to the agency when they were not. There is also a boomerang aspect to this argument. If the agency thought third party audits were a substitute for regulatory audits why didn’t they take more of an interest in understanding or verifying them. If they weren’t a substitute why didn’t they audit high risk foods more rigorously.

  • http://www.johnmunsell.com John Munsell

    FSIS “Guidance” documents are a source of confusion not only for the inspection force, but also for meat plant managers. Example: in March, 1998, FSIS issued a “Guidance for Beef Grinders to Better Protect Public Health”. This Guidance included 21 references to Traceback, Trace Forward, Trace Back, Trace, Tracking, Tracing, Tracking System, and Traceability. Subsequently, FSIS has displayed a cavalier ambivalence and refusal to perform tracebacks. Almost 14 years after FSIS published this Guidance document, the agency requested approval from OMB to perform Tracebacks subsequent to Verification Sampling Positives. If FDA issues Guidance documents, then ignores them as FSIS has the above Guidance for Grinders, we can assume FDA is not committed to the Guidance, and 3rd party auditors can play loose and easy with their review of plant practices. How can meat plants or produce companies be charged with noncompliance to Guidelines when the regulatory agency itself artfully dodges implementation of the Guideline? Indeed, compliance to Guidelines is voluntary. But if the Guidance is truly beneficial, it should morph into a regulation. Then, compliance with the regulation is required not only from the industry, but also by the regulatory agency.
    FSIS has always contended that Meat Plants’ HACCP Plans must say what they (meat plants) do, but the plant must then do what the HACCP Plan says. Same should be true for agency-released Guidance documents: agencies must proactively embrace and endorse what their guidance documents say.
    Public Health would benefit by FDA not following FSIS lead on this Guidance issue.
    John Munsell

  • http://www.quafsi.cl Raul Vergara

    I am writing from Chile, and I fully agree that the way audits (under different stanndars) are often not carried in a professional way.
    In same cases it can be lack of competences from the auditor, but there is a bigger issue: unfortunately for the CB, certifications are part of their bussiness and therefore they want to earn as much as possible in the different market. Due to the above CB don’t want to loose customers, and therefore in same cases they even ask auditors not to rise more than XX Non Conformities. In this cases there is a problem both from the CB and from the auditor that because doesn’t want to loose his job, accepts this irregular situation.
    And I don’t feel that the Acreditation Bodies are vey active in following up the activities of the different CB’s
    Therefore it is not easy to solve this issue, but clearly things need to be done.

  • David

    3rd party auditing firms give advance notice of their audit, so what they see is a dog and pony show. The plant is clean, the records up to date, etc. The auditor spends most time looking at records and a few minutes in the plant. While in the plant they look for bugs, holes in walls, inspect rodent traps, look a hairnets, etc. It’s nothing very detailed. There is very little inspecting food contact surfaces and what microbial issues may be present. A “Superior” score means the plant and records looked good for one day, and that is all it means.

  • Ted

    I have worked in the food industry for the past 25 years, in both food manufacturing and as a consultant. To be quite honest, the USDA, FDA and Third Party auditors add little to no value to the safety of our food supply. The USDA and FDA should both be eliminated (as we know them today) and a new Food Agency established that serves as a “mentor” to the manufacturers, establishing strict criteria that must be followed and using “random” audits of both product and facilities to identify where the programs are working and not, then holding manufacturers responsible when they do not meet compliance. Our approach to managing food safety in this country is wrong and totally ineffective. Unless you are a key supplier to a large customer (i.e. Wal Mart, McDonalds, etc…), you are not motivated to do the right thing. And especially in the current economy, most companies (not all) are strictly motivated by profit, which means that they will cut corners when possible (i.e. no micro testing on their finished goods, etc..) because they know very few people are looking. The bottom line is that our food industry is out of control and those that are the weakest link in the food safety chain are allowed to get away with whatever they want, constantly putting the consumer at risk, using “staged” third party audits to divert the attention away. I speak from experience. I speak from working with and for some of these same type of companies. I see how ineffective the USDA is as is the FDA, and how pathetic the third party auditing process is. Good companies are just that. They take their responsibilities seriously and put their best foot forward. It is the irresponsible companies that my comments are about and the lack of attention they currently get. The current food safety program is broke. It is now time to do the right thing and fix it. How many more examples of failure do we need?

  • http://www.lgma.ca.gov April Ward

    What’s missing in the recent food safety debate is mention of programs like the California Leafy Greens Marketing Agreement (LGMA) which address many of the concerns now being raised about audit systems in the produce industry.
    Our program has chosen to use government auditors to verify that food safety practices are in place on leafy greens farms – we believe that government auditors provide truly-independent food safety audits.
    But we also want to stress that any audit is only one part of a strong and successful food safety program. The LGMA’s food safety program includes a set of rigorous standards for growers to follow, a compliance program that requires corrective actions to be taken on all findings, and the ability to adapt and improve as research unveils more information about pathogen control on the farm.
    Over 200 billion servings of leafy greens have been produced under the LGMA; yet it is often overlooked in this debate. We believe the LGMA program provides a successful food safety model that can be applied across the produce industry, and we are happy to share with anyone who is interested.

  • Randall

    A lot of insightful comments, showing that maybe the auditing system itself should be more systemic, and that commodity be tested and facilities swabbed and tested for all microbials. I may be wrong, but I don’t think that the audit at Jensen Farms was a food audit like everyone says – it was just a building audit.
    Maybe a better audit would have discovered the Lysteria and we wouldn’t be having this discussion at all, but the auditors can’t make the growers order the more thorough (and expensive) food safety audit.
    This might be one of those times to let Congress act by promulgating standards for growers, distributors, and auditors. But lets not kid ourselves – True government oversight would be so cumbersome on the governments fund that it is impossible.
    April may be right – a commodity by commodity marketing agreement may be helpful, though I think the spinach situation pointed out significantly different issues than the cantaloupes do.