For juice processors, whose very philosophylies in providing the freshest tasting, most nutritious products possible, the Food andDrug Administration’s imminent Hazard Analysis and Critical Control Points (HACCP)regulations are an uneasy topic. Many juice processors – large and small, fresh andpasteurized – feel strongly about their production methods, and many, especially those whodo not pasteurize, feel additional processing will sacrifice juice integrity.

But it is likely the FDA will mandateHACCP, and the industry has been actively consulting on the topic.

In April 1998, the FDA published theproposed regulations for HACCP Procedures for the Safe and Sanitary Processing andImporting of Juice. In the time since then, the juice industry has worked closely with theFDA, through test programs and industry workshops, to develop HACCP rules that areeffective in meeting safety goals, and appropriate for juice processors and the many typesof products they produce.

Some of the most debated issues include thenecessity for pasteurized juice makers and small processors (those who produce less than40,000 gallons per year) to adhere to HACCP regulations, and the proposed standard of a 5log (99.99 percent) reduction in pathogens, which the fresh juice industry says isimpossible to meet with current technology.

Up for discussion
It is unclear at this point how these issues will be resolved – early this year, the FDAre-opened the HACCP standards for discussion. But in the interim, it has required fresh,unpasteurized, non-citrus juice processors who have not achieved a 5 log reduction inpathogens to place warning labels on their products, and gave an extended deadline of July1999 to citrus juice processors who have not achieved that standard.

“My sense is that [the FDA] has beengetting quite a bit of pressure from the pasteurized groups to avoid having HACCP apply tothem, and they’ve probably been getting pressure from other groups that the 5 logreduction may not be appropriate,” says Marc Isaacs, president of Sun Orchard FreshCitrus Juices, Tempe, Ariz., and president of the American Fresh Juice Council.

“The good news is that in spite of theuncertainty as to what the final regulations are going to say, a number of members of thefresh juice industry have taken steps on a pro-active basis to implement HACCP programs intheir facilities. In fact, I would say that a large percentage of our members in theAmerican Fresh Juice Council have implemented HACCP plans in their facilities, and manyhave also, whether they agree with it or not, achieved a 5 log reduction,” saysIsaacs.

Industry/FDA cooperation

The FDA has been conducting research onvarious types of juice, such as Apple in a Northern California study, and citrus with thehelp of a fresh citrus juice task force in Florida. Fresh Samantha, Saco, Maine, is amember of the American Fresh Juice Council and is taking part in a pilot program with theFDA to examine HACCP in the plant, tracing safety steps all the way back to the field.

Pamela Fischer, manager of qualityassurance at Fresh Samantha, praises the work between the industry and the FDA. “Ithink it has come together really well. I think there’s been good cooperation between theFDA and the juice processors. There’s been a great sharing of information, and it hasn’tbeen as painful as I think some people thought it would be.”

Cost of compliance

An important aspect of the proposedregulations will be the cost of compliance, with both training and documentation among thebiggest issues non-HACCP facilities will face, according to Fischer and Isaacs.

“With or without HACCP, you still needto have your Good Manufacturing Practices,” says Fischer “…you need to be ableto document that you’re doing [GMPs] and keep track of everything you are doing. Foodsafety all comes back to training and monitoring. For companies that do not have thepersonnel to do that, I suppose they’d have to add that.”

Isaacs says, “The biggest issue thatI’ve heard about from the smaller processors is the fact that documentation is verydifficult. You may have a very small employee base and because of that, in addition todoing the pressing and the bottling and everything else, they’ve got be taking down allthe information that’s got to be documented.”

Such documentation would be kept on-siteand made available to the FDA in case of an audit. It would also be invaluable in the caseof an outbreak. Individual HACCP plans would not, however, be filed with the FDA.

“There’s no question that for HACCP tobe effective there’s got to be a whole change in the culture,” says Isaacs.”When we developed our HACCP plan, our first step was going back to our goodmanufacturing practices and our sanitation procedures and making sure those were at a highlevel. Then we stepped into the HACCP world and started analyzing the critical controlpoints and at what points in our process there could be any type of contamination.

“Clearly there have been additionalcosts from a training standpoint, and an equipment and a capital standpoint, whether it’schlorinating equipment or grading.. It is definitely a more expensive process on allfronts,” he says.

As to whether or not pasteurized juicemakers and small processors need to be included in the final HACCP regulations, theposition of the American Fresh Juice Council is yes on both counts.

“We feel that HACCP is important forall juice processors, pasteurized and unpasteurized, and that’s because it is not onlyimportant to review your process from an extraction and fruit processing standpoint, it’sjust as important to make sure that the bottling and the handling after it’s manufacturedis done on a cautious basis,” says Isaacs. “I think that the HACCP plan is agood way for any processor, large or small, to walk through their entire process andunderstand where the potential is for contamination.”

Appropriate guidelines

An issue still up for discussion is theestablishment of appropriate guidelines for different juices. Apple, vegetable and citrusjuices, for example, have different potential risks and sanitation issues.

“What we’ve been trying to push andwork with the FDA on is ‘why don’t you complete the research that’s out there being doneand then determine what makes sense for the industry based on the results of the research- what has to be done for certain juice types vs. other juice types; what is theenvironment that some of these pathogens are growing in’ –  so we can go directly tosome of those areas,” says Isaacs.

In a letter to the FDA, the council hassuggested that if a performance standard is implemented, there should to be”clarification as to the scientific basis for the proposed standard and how thatstandard applies to each specific juice type.” It has also requested a phase-in planthat would allow for a 3 log reduction after two years, and  a 5 log reduction afterfour years, to allow the industry to develop alternative technology.

Isaacs says he hopes to eventually seestate and local agencies take a hand in helping processors adhere to HACCP regulations. Hesuggests that the FDA delegate some of the authority for inspections to local agencies.

“We would hope that the FDA would workwith the state and local agencies so if there are problems, the processor would be madeaware of them quickly and would be required to make changes to their systems if they arenot adhering to GMPs or sanitation practices,” he says.