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.