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Preventive Controls: Daunting for Some, Standard Procedure for Seafood

The concept of “preventive controls” is an anxiety-producing one for many FDA-regulated food companies right now as the agency prepares to issue a final rule that will make hazard-prevention measures mandatory for processing facilities.

As Food Safety News reported last week, trepidation is especially high among smaller firms, which are balking at potential costs of meeting the new requirements. But for the seafood industry, which has been under a mandatory preventive controls plan for almost two decades, the new rule triggers memories rather than fear. The message coming from this industry is: “We were able to do it, and you can, too.”

Seafood is one of only two types of food that the U.S. Food and Drug Administration requires a preventive control plan to process (the other is juice). These plans, known as HACCP (hazard analysis and critical control points), bear a close resemblance to those that will be required of other industries under the FDA’s new rule, known as HARPC (hazard analysis and risk-based preventive controls). Both systems focus on identifying points in processing where hazards may compromise food safety and implementing preventive measures at those points.

But while some in the fresh produce industry are daunted by the new HARPC regulations  (one processor called it “the end of many small- and mid-size farms”), the seafood industry says it has been there, done that, and that it came through the experience as a stronger sector.

“The complaints we’re hearing from the other industries as they look at these preventive measures are almost identical to what we heard from the seafood industry when HACCP was introduced,” says Dr. Steve Otwell, a seafood specialist with the University of Florida Sea Grant and national coordinator of the Seafood HACCP Alliance. “Surprisingly, HACCP has been accommodated, has been implemented in the seafood industry, and it has not had the financial consequences that some feared. ”

The costs of implementing HARPC have been put at approximately $701 million for the first year and then $472 million annually, according to estimates from the White House Office of Management and Budget. It’s these numbers — and the complexity of a HARPC plan itself — that have processors of other FDA-controlled foods, especially smaller ones, worried.

How seafood came to adopt HACCP early

The fact that the majority of seafood-processing firms are small or medium in size prompted the seafood industry to request HACCP regulation back in the early 1990s, according to Kenny Lum, president of the Seafood Products Association, which provides processing assistance to Northwest seafood companies. At that time, Lum says, European buyers were beginning to require preventive control plans of their American suppliers, while American consumers were expressing concerns about seafood safety and quality. The industry wanted to implement HACCP to prove to its customers that all seafood processors were producing high-quality, sanitary products.

“Industry had a concern because there are a lot of very small operators, so we really wanted to have sort of a regulatory safety net that everybody needed to operate under,” Lum explains.

A long and winding road

Just because the seafood industry asked for it doesn’t mean the road to HACCP implementation was a smooth one. At first, processors were overwhelmed by the new rules.

In January 1999, two years after FDA’s HACCP rule for seafood had gone into effect, the agency published a Q & A document to help processors with the challenges they were facing.

“A large number of questions have been raised by the seafood industry, regulators, consumers, and others about interpretation of the regulation,” FDA stated in the introduction to its Q & A document.

The Q & A was intended as a supplement to another document FDA wrote to help seafood processors comply with HACCP: the “Fish and Fishery Products Hazards and Controls Guide,” or “The Guide,” now in its 4th edition and published in 2011. Otwell says The Guide has become a crucial tool in helping seafood processors navigate HACCP.

“It has really turned out to be a seafood safety bible,” Otwell says. “Everybody, whether I’m in China, the United States, Florida or Massachussetts, everybody can go to the same book of recommendations.”

“That’s what helps us through those challenges, particularly small processors,” Lum says of The Guide. “It gives us a format.”

Education crucial to alliance

As helpful as The Guide has been for seafood processors, both men agree that HACCP implementation would not have been successful without the educational efforts that accompany it.

That education comes in large part from the Seafood HACCP Alliance, a collaboration of academics, government agencies and industry formed in 1995 to provide HACCP training and support to seafood processors.

“Training is the essential part of HACCP — making sure that even the small processors, since they’re going to be subject to regulation, go through the training,” says Lum.

In order to make this education happen, industries now coming under HARPC are going to have to work with university extension programs and government agencies to develop a training support system that’s accessible to all processors, says Otwell, who is the national coordinator for the Seafood HACCP Alliance.

“[Cost] should not be a hurdle. Education should be available for everybody to help this thing happen and cost should not be an impediment,” Otwell says. “If people have not accounted for educational delivery, that imposes a pretty heavy cost.”

“The Seafood HACCP Alliance is a model that everybody else is trying to follow, but we came up with it at a time when the universities were funded to do these sorts of educational things. Now things have gotten tougher. Budgets across the United States are tighter, so the delivery’s going to be a little more difficult.”

That’s why Otwell says that it’s crucial for government, universities and the industry come together to figure out an education plan for the new preventive controls.

An ever-evolving process

Despite the fact that seafood has been making friends with HACCP since FDA issued its final rule in 1995 (two years before it was implemented), the industry still faces difficulties associated with these standards.

“It continues to be a challenge for small processors as well as new processors coming into the business,” Lum says. “Sometimes it just becomes overwhelming and they just decide maybe they’ll do something else. Maybe manufacturing toys or something,” he jokes. But for those willing to get serious about HACCP, the tools are there to help them.

One key to ensuring that HACCP stays effective — and not prohibitively expensive — is flexibility in the rules, he says. While FDA’s HACCP rule says seafood processors can adjust regulations to fit their businesses if they can prove that what they’re doing is just as effective, he says many processors, especially smaller ones, lack the resources and knowledge to put together the data needed to make these changes.

For example, while HACCP requires processors to record storage temperatures every 30 minutes, for some firms, such as those in very cold climates, this might be unnecessary since years of records will show that temperatures never fluctuate that quickly. Processors need to know how to present this type of data to FDA in order to get a change in process approved, Lum explains.

Adapting the HACCP rule is something Otwell says FDA could work on, both for the benefit of inspectors and processors.

“Inspectors get put into situations where they have to make judgment calls but don’t have information,” Otwell notes. “There needs to be some way of constructive exchange so that it can be shared across the wider community.”

This is something he suggests FDA work on with other industries as it moves forward with the preventive controls rule.

Looking toward the future

Although the seafood industry will not be subject to the new HARPC rule, it continues to evolve its HACCP plan. One aspect that will be important going forward is translating HACCP into other languages so that foreign processors are on the same page, Otwell says.

New estimates have found that 90 percent of seafood consumed in the U.S is imported. Because of this, a big part of HACCP compliance now is making sure that foreign suppliers understand and incorporate these preventive controls into their food safety culture, he says.

“So if you’re going to get the training across, not only does the language have to be there, but you’ve got to be mindful of how they learn and their cultures,” Otwell points out. “And it’s different in different locations. So looking back over the past 15 years, that’s one of the lessons there from the seafood alliance that the other groups could pay attention to.”

Lum says he hopes pathogen interventions for ready-to-eat foods such as tuna and oysters will get more attention. While processes such as irradiation for oysters have been approved, they are not currently required under seafood HACCP.

“That’s really one of our focuses is this very category of minimally processed ready-to-eat foods because we believe we can build risk assessment models and put in the interventions,” Lum says.

What do other industries have to look forward to? Otwell says mandatory preventive controls help everyone get on the same page.

“One thing that was dramatic [about HACCP for seafood] – it changed the whole knowledge base and the whole language of communication. Before HACCP came along, people didn’t talk about sanitation control procedures. Now everybody can communicate and compare things. [HACCP] definitely raised attention and awareness, and if you’re aware and you get into a more preventive mode, obviously you’re going to have some impact.”

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