September, 1997

FDA signals move toward mandatory cider HACCP, warning labels

After months of waiting, the U.S. fresh juice industry now knows what the Food and Drug Administration plans for future regulations.
The August 26 announcement applies to unpasteurized juices. The "notice of intent" is not the actual recommended regulations - FDA is aiming to have those completed by the end of 1997. A period of public comment and governmental review would follow, which may allow the law to be on the books before the 1998 season.
By that time, the face of the apple cider industry may have already changed dramatically.
The FDA document calls for a mandatory Hazard Analysis and Critical Control Points (HACCP) plan to be put in place by producers of non-pasteurized juice. Until such a plan is in place, FDA is recommending, not requiring, warning labels to be placed on juice containers.
Some cider producers have already purchased pasteurizing units. The majority of producers have increased their knowledge of bacterial pathogens and their prevention and will take this information into the new season. A few have gone out of business, feeling they cannot bear the financial burden of either a pasteurizer or the additional facilities and recordkeeping.
"The HACCP measures will take time to be in full effect," said William Schultz, FDA deputy commissioner for policy. "In the interim we are asking the industry, as a voluntary public health service to their customers, to begin immediately labeling fresh apple juice and cider product with a statement of the risk."
FDA has "tentatively concluded" that the warning labels should contain three elements
A statement of the potential presence of bacteria that cause serious illness.
A statement that the product has not been processed or heated to destroy harmful bacteria.
A statement that children, the elderly and people with weakened immune systems are at greatest risk of illness from exposure to harmful bacteria in juice products.
In a written response to the proposals, the U.S. Apple Association said it supports communication with consumers about food safety and has recently sent a packet of such information to cider producers nationwide. The association asked FDA to recognize the voluntary effort of the industry to respond to the threat, see the risk to apple cider in comparison to that of other foods, advise consumers on how to distinguish between pasteurized and unpasteurized products, advise consumers on safe consumption of cider, and use the designations "pasteurized" and "unpasteurized/fresh" rather than "cider" and "juice."
USApple wants to see FDA rules that are scientifically supported, said Julia Stewart Daly, director of communications.
"We encouraged FDA to do a risk assessment and let that guide us as to what level of response is needed here. We want to make sure no one is over- or under-reacting," she said.
Mandatory HACCP plans have either been mandated or are already in place in the meat, seafood and poultry industries. In none of those cases were warning labels required in the interim period, said Daly.
"The industry is working very hard to deal with the problem," she said. "We just want to make sure that whatever gets proposed is appropriate."
The cider producers who have already decided to pasteurize are citing repercussions from any contamination incident and pressures from the marketplace as reasons to make the move.
"If somebody gets sick, I can lose everything but my home," said Alvin Hill, partner in Hill Brothers Orchard, longtime cider makers near Grand Rapids, Mich. The business decided in January to pasteurize and installed a new unit in time for this season. "I have many customers asking for pasteurized product this year, and I'd put down a $100 bill that pasteurization will be required next year."
Dennis Courtier of Lake City, Minn. made the decision to pasteurize his Pepin Heights Orchard cider in 1995. He believes the only way to guarantee a reliable and safe product is flash pasteurization.
In the present wholesale marketplace, unpasteurized product may already be a thing of the past, he said.
"Buyers are highly suspicious of anything that's not pasteurized because it will be their necks on the line, too," he said. "The people who aren't pasteurizing either can't read the handwriting on the wall or don't like it. If the industry doesn't adopt this technology on a widespread basis, it will be the end of the industry."
In Massachusetts, Frank Carlson calls the situation at his cider mill "frustrating to say the least." Carlson Orchard produces over a half-million gallons of cider each year and is pasteurizing its entire output this season.
The decision to pasteurize means a three-week delay before the Carlson mill is up and running. Until then, he is sending out the bulk product to a dairy for production.
"We have decided to not sell one gallon unpasteurized," said Carlson. "We just don't want to assume the liability. It's market driven - we just can't fight the advocacy groups."
All three cider makers said the taste of their pasteurized product was good. Hill said the only difference was a slightly lighter color while Carlson characterized the taste as "very acceptable."
A period of public comment has already started, although FDA suggests comments may have more impact if delivered after the final rules are proposed. The agency has also hinted it will phase any new regulations in over a period of years.
Industry observers are watching to see whether the regulations will result in pasteurization. FDA is considering requiring that any measures used under a HACCP plan to kill detectable pathogens do so at a "5-log" rate. This would be a provable method to eliminate 99.999% of the detected bacteria. Any juice producer that can accomplish this step would not need a warning label on its product.
"Based on available information, however, the agency considers pasteurization the only process validated to meet this standard at this time," said the FDA intent document. "However, the agency solicits comments on other ways to achieve this reduction."
The future cider market may still have a place for the unpasteurized product - sales directly from the farm. Courtier believes a "buyer beware" situation may evolve when the customer goes to the cider mills, makes a judgment on how clean and safe the operation is and then decides whether to buy the product.
"I think people will come to our farmstands to look for old-fashioned unpasteurized cider and will expect to find pasteurized in chain stores," said Carlson. "I still think there will be a niche for the good old-fashioned product."