July, 1998

Warning labels required, HACCP rules on the way

Warning label regulations for cider and other fresh juices are now in place after their release July 8. The other anticipated regulation, covering establishment of HACCP procedures, is nearing completion after closing of the comment period, which also took place July 8.
This season, cider manufacturers who do not have a HACCP plan in place must place warning labels on the container. The need for these labels was disputed by the U.S. Apple Association and others, but the regulations remained unchanged from when they were first proposed. Cider makers across the nation are waiting to see whether the Food and Drug Administration will be similarly unmoved by comments on the HACCP regulations.
"It's my personal opinion that the FDA already has a pretty clear understanding of what it wants to do," said Jim Cranney, USApple 's vice president of industry services. "I don't expect them to be swayed one way or another by any concerns that come in."
HACCP is indeed the wave of the future of food safety regulation within FDA. Already, seafood, meat and poultry operations have been required to adopt it.
"We feel it is a more effective food safety strategy, enforcement tool and safety program for industry than strictly GMPs alone and our inspections based on GMPs," said Darrell Schwalm, assistant manager for FDA's HACCP policy.
A major area of concern in the HACCP regulations is the performance standard they set of achieving a five-log (100,000-fold) kill of any pathogens detected. Currently, the only single step known to achieve this five-log step is pasteurization, although the rules do not specify how the kill is to be achieved.
But why five logs? USApple believes the five-log standard presumes the presence of the target pathogen. In real life, these pathogens are rarely found when processors are strictly using Good Management Practices (GMPs) and Standard Operating Procedures (SOPs). That fact should be taken into consideration, but wasn't, when the five-log standard was established, according to USApple.
The five-log standard was established at the urging of the National Advisory Committee on Microbiological Criteria for Foods. It was arrived at "by consensus of the expert panel as a target that would provide adequate public health assurances while minimizing the impact of treatments on the sensory attributes of the juice," said scientist Robert Buchanan, in a memo recalling the discussions.
No quantitative data was available on the levels of E. Coli 0157:H7 that could be expected in apple cider, according to the memo. Instead, the panel made a series of assumptions and extrapolations to come up with what it called a "worst case scenario" indicating that a five-log reduction would remove the pathogen and provide the necessary safety margin.
Another reason the agency settled on the five-log benchmark was that "there is significant regulatory precedence for this value," said the Buchanan memo. Microbiological reduction targets of five logs already exist for salmonella in liquid egg pasteurization and E. coli in fermented sausage, for example.
Michigan Department of Agriculture comments propose that performance standards for fresh juice be based on levels of human pathogens actually found in the product plus a safety factor of one or two logs. If insufficient data is available, MDA suggests using total E. coli counts to indicate the level of fecal contamination possible.
"The level of risk should drive the regulatory decision making process. HACCP may be an appropriate solution to some food safety problems, but is an overreaction in this instance. USApple is opposed to the mandatory implementation of HACCP on the basis that it is unnecessary for many producers. Rather, HACCP should be among the options available to producers for achieving the appropriate reduction in the target microorganisms," said the USApple document.
Producers of under 40,000 gallons of cider a year are exempted from the regulations, as are people who produce juice for consumption on the premises. Both USApple and MDA comments urged removal of the 40,000-gallon exemption. A USApple national survey of cider producers indicates that nearly 80% of the industry would be exempt.
"The actions of one producer can have profound impact on both consumer health and public perceptions regarding food safety," states the MDA comments. "We urge the Agency (FDA) to work with other regulatory agencies and stakeholders to ensure the uniform adoption of reasonable risk reduction practices."
Some cider producers who sell their product only within their state have been wondering whether the FDA regulations apply to them. The final warning label regulations state that juice solely a product of intrastate activities is not subject to FDA's jurisdiction and thus not subject to the warning statement requirement. However, in these circumstances, FDA routinely works with state regulatory agencies who also have a mission to protect the public health.
Jerry Wojtala, MDA science and technology section manager, said his agency is consulting legal counsel on the jurisdiction question. "We would feel more comfortable knowing the answer to that because we will be the ones out there enforcing it," he said.
USApple supports a two-year phase-in period for producers to achieve FDA's final food safety goals. In addition, all producers not currently able to meet these goals would be required to display a "consumer information statement" on the package rather than a warning label.
The label would say "This is a natural product that has not bee pasteurized or otherwise treated. There is a risk that it may inadvertently contain harmful bacteria that can cause serious illness in children, the elderly and persons with weakened immune systems." USApple has asked FDA to form focus groups to evaluate this statement.
The association believes its language would serve to educate consumers more than the FDA language, without frightening them.
"FDA's newly-required warning label creates the impression that consumers are at grave risk from the consumption of unpasteurized cider," said Kraig Naasz, president of USApple. "The actual risk of serious illness is extremely low, especially when compared to other food groups that are more commonly and appropriately associated with foodborne illness."