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 In March 2010, FSIS posted an initial draft guidance to help the industry, particularly small and very small plants, comply with the HACCP validation regulations that were already on the books.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 This may sound like a straightforward idea, but the agency’s draft guidance set off a firestorm of concern among small and independent plants with few resources to dedicate to regulatory requirements.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.”