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HACCP Validation: A Long Road to Clarification

While the U.S. Department of Agriculture’s Food Safety and Inspection Service has been requiring meat and poultry plants use Hazard Analysis and Critical Control Point, or HACCP, systems since the late 1990s, the details of how exactly plants validate those systems to ensure they work has been a topic of recent debate and increasingly a focus of the agency.

According to FSIS, the initial roll out of HACCP across the industry was focused on making sure all plants had met their basic requirements, but as the years rolled on the agency became concerned about whether small and medium sized plants had designed and documented their systems with enough rigor. In March 2010, FSIS posted an initial draft guidance to help the industry, particularly small and very small plants, comply with the HACCP validation regulations that were already on the books.

When FSIS talks about validation, it’s referring to the process of demonstrating that a HACCP system works as it is designed to. There are two parts to validation, according to the agency. The first is making sure you have the right technical or scientific justification that the process can control the particular hazard, whether it is Salmonella or E. coli O157:H7. The second is proving the system can actually do what it is supposed to, that the plan on paper works in practice.

This may sound like a straightforward idea, but the agency’s draft guidance set off a firestorm of concern among small and independent plants with few resources to dedicate to regulatory requirements. Of the roughly 6,000 plants FSIS regulates, nearly half of them are very small and another 2,000 are small, while 391 are categorized as large, according to the agency.

In June 2010, when FSIS held a public meeting at USDA in Washington, DC to discuss the first draft of the guidance, Administrator Al Almanza told the audience that he had held the document for a while saying, “I knew it was going to have a significant impact across the Agency.”

“I am excited about the opportunity to have this public meeting and the additional two meetings because I think that we need to clarify what our position is, and that’s one thing that I think got lost along the way,” said Almanza.

FSIS’ position had gotten more than lost. Many in the industry were concerned the guidance was a warning that burdensome testing requirements were coming.

Bob Hibbert, a lawyer representing the Eastern Meatpackers Association, summed up the concerns among small and medium sized operations.

“What you would hope, after about 15 years or so of HACCP, is that we would all be moving in the direction where this is becoming increasingly known territory, where we have enough experience, enough precedent, enough understanding about what has worked and hasn’t worked to be increasingly useful for people navigating this space,” he said. “Unfortunately, despite the agency’s intentions, I think the current draft is a step backward in that regard.”

Hibbert said that people in the field – the ones who matter the most: people working in the plants and FSIS officials enforcing HACCP – were reading the guidance to mean that FSIS would be looking for a lot more tests results.

“The message to the establishments now is you’d better test the heck out of everything if you want to avoid problems with enforcement,” said Hibbert. “That’s a problem.”

Joe Cloud, co-owner of True and Essential Meats, a very small multi-species plant in the Shenandoah Valley in Virginia, appeared at the meeting after writing to FSIS expressing concerns about how onerous testing requirements could harm his business, which is booming thanks to the growing local food movement.

“I’m here today because I do have a concern that FSIS does not necessarily understand the needs and realities of very small plants,” said Cloud.

“I’m here to ask that the agency keep in mind the realities of small community-based plants as you proceed,” he said.

Over the past three years, the agency has made a concerted effort to clarify the guidance and help smaller plants understand what is expected of them and how to comply.

The outreach has included web seminars, public meetings, trainings, and fielding more calls through the small plant help desk, a resource of experts available to answer questions and help plants comply with food safety and labeling requirements.

The agency also considered more than 2,000 comments from stakeholders on the first document and worked to address the concerns.

In May 2012, FSIS posted a revised draft guidance document and asked for more input. On the second draft, stakeholders logged just 50 comments.

“We have finally gotten to a place where the guidance is more understandable and user friendly,” said Daniel Engeljohn, Deputy Assistant Administrator, of FSIS’ Office of Field Operations. “Truly, it’s because we’ve been responsive to the comments. “

FSIS inspector and plant personnel review plant documentation to ensure compliance with a HACCP plan on May 13, 1996. USDA photo by Bob Nichols courtesy of flickr.

“We wrote it so it would be especially helpful for small plants,” said Engeljohn, pointing out that FSIS has included more examples and explanations in the latest draft. FSIS has also charged its Enforcement, Investigations, and Analysis Officers (EIAOs) to be more helpful to plants that need it.

“We’re not writing their plans for them,” said Engeljohn, “but answering their questions.”

Tony Corbo, a lobbyist for Food & Water Watch, a group often critical of USDA, gives credit to the agency for their work on the guidance.

“They’ve made progress in terms of trying to give flexibility to the small guys,” said Corbo.

Faith Critzer, a food safety extension specialist and professor at the University of Tennessee agrees that FSIS outreach has been key.

“I think they’ve been putting their best foot forward,” she said. “They’ve been working in good faith with industry to make it as easy as it can be.”

“I think it’s just as important for small and medium size plants as it is for large,” she added. “It’s just harder for smaller and medium size plants because they don’t have the same resources.”

Through the University of Tennessee’s food safety extension program, Critzer works with plants of all sizes to help them improve their food safety practices. The extension pulls scientific literature to help support HACCP plans. They also help processors figure out whether they need to do their own study to back up their practices or whether they can tweak their process.

Corbo does remain concerned about how firms can get access to the information they need about validation.  In 2011, the National Advisory Committee on Meat and Poultry Inspection (NACMPI) recommended that FSIS support the creation of a consortium of scientists, processors, extension specialists, consumer groups, and trade associations to focus solely on validation.

“FSIS doesn’t seem to be interested in doing that,” said Corbo.

Plants of all sizes do have resources at their disposal. Agricultural extensions can be invaluable, companies can call the small plant desk, seek out scientific research on their own, or use industry associations and experts – but all of this takes time, and if further study or testing is needed, money.

While everyone seems to agree FSIS has made strides in better communicating what they expect, and making the guidance more useful, there is still uncertainty about how it will all work in practice.

Critzer said she thinks the FSIS’ validation guidance is on the radar of many small plants, but “it’s not necessarily something they’ve spent a lot of time on.”

Three years after the initial public meeting on HACCP validation, Joe Cloud, of True & Essential Meats, told Food Safety News he is still not sure quite what to expect, but he remains concerned about the amount of work that could be required to meet the validation requirements, since his very small plant does not have dedicated scientific staff focused on HACCP like large plants do.

“I really don’t know exactly what’s going to be required,” he said. “There are still a lot of unknowns.”

© Food Safety News
  • John Munsell

    Some considerations.

    Large plants, killing up to 6,000 beef per day, have their own in-house labs, and collect dozens or hundreds of tests daily. The cost can easily be spread over the thousands of head killed daily. Small plants, most of which do not even slaughter, suffer from miniscule-sized sales volumes, and find it financially impossible to test daily…….or even weekly. And, many of these small plants make a multitude of specialty products, primarily cured, smoked meats such as a
    variety of bacons, hams, sausages, etc. A concern subsequent to the March 2010 guideline was that FSIS expected all plants to conduct frequent lab testing of all products. When a plant makes very little of a product, lab testing fees overwhelm the ability of the plant to cover the cost.

    We must remember the numerous cautions which have been raised that testing [alone] does NOT produce safe food! Testing is an indicator, which can show that a plant has problems. Given the small incidence of pathogens (perhaps 3/10ths of 1 %), the probability that collecting 1 lb meat out of 10,000 lbs will actually detect the presence of pathogens is not good. Last year, USDA’s OIG stated that the agency’s n-60 testing protocol would most likely NOT find
    pathogens when present. When plants send in a meat sample for lab analysis, the lab report only states that the sample did not contain pathogens, while making no guarantee that the rest of the lot is pathogen-free. Smoked, fully-cooked meats are less likely to harbor invisible pathogens.

    Perhaps my major problem with testing is the agency’s ho-hum response when pathogens are found, WHEN THE MEAT ORIGINATED FROM A MAJOR PACKER! Imagine this scenario: Paul’s
    Processing Plant, a downstream further processing plant which purchases all its meat from large, source slaughter providers, tests trim or ground beef for E.coli, and the test is positive for the pathogen. Well, what should USDA do to protect consumers in such a case? Answer: shut down Paul’s, while insulating his source provider(s) from accountability. The agency’s bias becomes more clear when we realize that until a couple years ago, FSIS did not allow its inspectors to document the SOURCE of meat being tested at the time of sample collection. This means that if a FSIS inspector collected a sample at Paul’s for E.coli analysis, and Paul purchased the meat from Tyson, Cargill or whomever, the agency did NOT allow the inspector to document that the meat originally came from Tyson or Cargill. Agency actions at my
    plant in 2002 were not unique, but have been replicated countless times across America…….in small plants. Agency-collected ground beef samples at my plant produced 4 e.coli positives, and the inspectors who collected them admitted that the meat was purchased from Est 969 in Greeley, CO, which was then owned by ConAgra. The inspector had all the details (for which he
    got in trouble). How did FSIS respond to such irrefrutable evidence? It shut down my grinder for four months, while the Greeley plant did not lose one minute of production. Please believe me, this has occurred countless times, arguably not as eggregiously as what happened at my

    For years, FSIS authored policies which made tracebacks to the source impossible. Somewhat better now, but it has a ways to go.

    So, what do adverse lab results VALIDATE? In the eyes of FSIS, adverse test results at downstream further processing plants prove, or validate, that the small plant has failures
    in their HACCP Plans! Forget about the source of the pathogen! Manure runs downhill, and FSIS is perfectly comfortable allowing the large source slaughter plants to ship pathogens into commerce, and then attempting to detect and remove pathogens at downstream further processing plants. Let the horses out of the barn, then spend one’s primary focus finding the horses out in commerce.

    Helena, exactly WHAT does an adverse lab result validate?

    Please remember that E.coli and Salmonella are enteric bacteria, which by strict definition means they emanate from within animals’ intestines, and by extension, are found on manure-covered hides. The vast majority of small, downstream further processing plants do not slaughter, meaning they have no intestines or hides on their premises. Yet, FSIS holds them ultimately and [primarily] exclusively responsible for pathogens detected on their premises.

    What are we validating? The ability of a further processing plant to (1) detect and (2) remove invisible pathogens from incoming meat?

    Or, should validation be conducted to initially PREVENT shipment of pathogens into commerce?

    Another major problem with Validation is how to develop a SCIENCE-BASED testing frequency protocol. In other words, how frequently should plants test their products? Should a plant test ground beef once a year, once a month, once a day, etc? I prophesy that the agency will use this issue to effectively shutter small plants, for their alleged noncompliance with frequency protocol. Helena, please know that NO science-based protocol currently exists! On June 24, I emailed Dr. Emilion Esteban, FSIS Excutive Associate for Laboratory Services in Athens, GA, (& copied Dr. Daniel Engeljohn) asking him for copies of science-based frequency sampling protocol. I’ve not heard one thing back from Dr. Esteban. On June 25, I emailed Dr. Kerri Karris, Pres of the International HACCP Alliance, asking her for copies of such protocol. Have heard no response from Kerri. I’ll forward these two emails to you.

    Helena, why no response from USDA & industry leaders? Because there is NO science-based
    frequency protocol available. Do you see the beauty of this, in FSIS’ eyes?

    Because FSIS won’t have to shut down small plants now because of their adverse lab results, but because of their noncompliance with “science-based” frequency protocol. Oh, by the way, such protocol does not exist.

    Validation can be an effective tool, when implemented properly. Unfortunately, FSIS is floundering on this issue, and not providing answers to what test results validate, and how frequently tests should be conducted.

    • tallen2007


    • Oginikwe

      So, if I am a big producer and I find that I have 50,000 pounds of ground beef contaminated with e.coli, what is there to prevent me from selling that to smaller plants knowing that they will be held responsible?