Data Refuting 5-Logs As Sufficient Kill in Juice

• Flaws in Development of 5-Log Standard
• Consumption of Juice Underestimated
• Levels of Contaminant in Feces Underestimated
• Fruit for Juice is Usually Considered "juice grade" - Ignored
• Growth of Pathogens on Fruit
• Quantity of Contaminated Fruit Underestimated
• Final Contamination Rates in Juice Underestimated
• Pseudo-validation with Insufficient Standards

A number of assumptions were made by the NACMCF; assumptions that in the last three years seem to have been proven less and less valid and are pertinent to issues of both multiple reduction methods and the overall sufficiency of 5 logs. Here are seven key points that we believe refute the validity of 5-logs: (slide)

1) The committee underestimated the amount of juice the at-risk group consumes. The committee assumed the average individual would drink only 100 ml or three ounces of juice a day. (1) Yet, a letter from Roger Suchyta, Associate Executive Director of the American Academy of Pediatrics to the FDA dated 1/31/97, indicated:
"A recent unpublished survey of mothers of children less than 6 months of age showed that 70% of babies less than 6 months of age drink juice, and 20% of those babies drink at least 16 ounces of juice a day. Ten percent of the infants drink 24-42 ounces of juice a day. The survey also assessed juice consumption of infants 7-12 months of age. One hundred percent of these infants consumed fruit juice and 20% consumed at least 12 ounces a day with 15% consuming more than 15 ounces a day."

2) The committee assumed a low number of pathogens in animal feces. The committee worked with an assumption of levels on an order of 10 to 4 to 10 to 5.(2) However, at the Florida citrus juice meetings last November, Jur Strobos indicated that, "When you have fecal contamination, the level of pathogenic organisms that you get in a fecal contaminant is usually in the 10 to 11 or 10 to 12 range." (3)

3) The committee ignored that fruit that is sold for juice production is generally of a lower quality than fruit that is sold for commercial sale.(4) Scarring, dimples, microscopic holes, and other deformities are presently acceptable in juice grade fruit and increase the probability of uptake and therefore the likelihood and levels of contamination, issues that S.T.O.P. has raised repeatedly in its public comments.

4) The committee ignored favorable growth conditions of pathogens on fruit prior to harvest, during harvest, during transit or in storage prior to juicing. The optimal conditions for growth of pathogens is close to human body temperature. If you combine pathogens on fruit with the 90-plus degree heat, light and humidity in the kind of climate under which oranges are grown and harvested in southern climates of different states, you've optimized for much higher growth rates beyond the rate of initial contamination.

5) The committee underestimated the quantity of contaminated fruit in a batch, presuming that only a "very small number of fruits in any one batch would be contaminated...Using a relatively conservative estimate, they assumed that 1 fruit in 100 would be contaminated."(2) Fundamental practices in an industry or at an orchard may render contamination far more systematic than incidental. Examples include the use of fecal fertilizers and sprays, the use of unsanitary fertilizer, irrigation or wash water, and the practice of picking the fruit up off the ground. In these circumstances, far greater numbers of fruit could easily be contaminated than the 1% concluded by the committee. One company at the Florida meetings indicated that when they rinsed the surface of the fruit with water and common detergent, they got higher microbial loads in their juice than when they extracted juice with no rinsing.(5) FDA's 1997 survey of apple cider producers indicated that that 10% (6), not 1%, of the fruit might be picked up off the ground. And even this rate is suspect given that it was not observed but was given by orchard owners who had been educated by the US Apple Association about the hazards of drop apples.

6) The committee assumed a low rate of contamination in juice. Indeed, the committee admitted it had little, if any data on the contamination rate in juice. It therefore worked with an assumption of less than 10 cfu/ml.(2) At the Florida meetings, Dr. Martha Roberts, the deputy commissioner in Florida indicated that for 1996-1998, 4% of the samples, at approximately 5% of firms were positive for E. coli, a fecal indicator organism, and one firm had a rate of over 100 organisms per ml.(7) In a 1994 state cider inspection cited in the 1997 FDA cider report, the highest fecal coliform levels found in juice were 240 MPN/ml. (8) Preliminary research at the FDA apple cider pilot plant indicates that "typical juices made under poor conditions with poor quality fruit resulted in aerobic microbial counts of over 5 log/ml, despite incoming rates of 3 log/gram."(9)

7) The committee pseudo-validated 5-logs in juice by comparison with pasteurized eggs and fermented sausage. However, the "standard" for pasteurized eggs was developed by the marketing branch of USDA, not by rigorous testing. Indeed, even today, FSIS is not strongly supportive of 5-logs being sufficient for eggs. Repeated recalls of fermented sausage products for contamination by E. coli O157:H7 calls into question the level of safety provided by 5-logs. 13,000 pounds of salami were recalled just last week.
As of the last time the committee made recommendations, the committee did not seem to have data on the prevalence of contamination on fruit or the use of drop fruit in juice.
Re: contamination on fruit. At the November citrus meetings, Dr. Jur Strobos indicated that under laboratory conditions, "one of the things we tried to do is to figure out what's the maximum concentration of organisms that we can actually get uniformly spread around? And the maximum that we can develop is in the 10 to the 7, 10 to the 8 range."(3)
Re: prevalence of the practice of using drop fruit. The State of Massachusetts has endorsed its cider guild SSOPs which support the use of drop apples.(10) In the 1997 FDA cider survey, 37% of firms reported using drops.(11) Note that drop oranges were considered a potential source of the unpasteurized orange juice/Disneyworld outbreak of 1995.(12)
To date, nationally SSOPs and GMPs are largely voluntary and vary by state. Compliance with voluntary guidelines is not high. When FDA requested voluntary labeling on unpasteurized apple juices, its 1997 survey of cider producers indicated that only 18% of the firms labeled their produce as unpasteurized, another 9% provided a warning statement on a sign, and 5% in a pamphlets. Thus, less than a third voluntarily provided some information on juice hazards. (13). Inspections found 4% of inspected firms were operating under poor sanitary conditions. (14)
 
ENDNOTES
(1) NACMCF conclusion:"The Committee believes that a tolerable level of risk may be achieved by requiring an intervention(s) that has been validated to achieve a cumulative 5 log reduction in the target pathogen(s) or a reduction in yearly risk of illness to less than 10-5, assuming consumption of 100 ml of juice daily."(2) Letter by Dr. Robert Buchanan to the Record, dated 6/15/98
(3) Jur Strobos from Transcript of Proceedings, FDA Technical Workshop; Citrus Research and Education Center, University of Florida, Lake Alfred, Florida, 11/12/98
(4) Dr. Mary Lu Arpaia has given data at the 12/8/99 NACMCF meeting describing the differences between process, choice and first grade citrus. Also from USDA Definitions of "Cider grade" apples. The USDA definition of cider grade apples is: "apples which are free from decay, worm holes and internal breakdown." Grade 1 and 2 apples are "not overripe, which are free from decay worm holes, freezing injury and internal breakdown and free from any other defect, or combination of defect."
(5) Transcript of Proceedings, FDA Technical Workshop; Citrus Research and Education Center, University of Florida, Lake Alfred, Florida, 11/12/98, page 90, lines 20-25.
(6) FDA: Report of 1997 Inspections of Fresh, Unpasteurized Cider Manufacturers, Summary of Results; Inspection Findings, Harvesting Practices
(7) Dr. Martha Roberts from Transcript of Proceedings, FDA Technical Workshop; Citrus Research and Education Center, University of Florida, Lake Alfred, Florida, 11/12/98, page 35.
(8) FDA: Report of 1997 Inspections of Fresh, Unpasteurized Cider Manufacturers, Summary of Results; State Controls section; State Inspections and Microbial Sampling Initiatives.
(9) FDA/CFSAN, Potential for Infiltration, Survival and Growth of Human Pathogens within Fruits and Vegetables, reference to preliminary research at the FDA apple cider pilot plant in Placerville, CA, 1999.
(10) "Sanitary Operation Procedures for Massachusetts Cider Mills," Massachusetts Department of Public Health, Div. Of Food and Drugs, Food Protection Program, 5/12/97
(11) FDA: Report of 1997 Inspections of Fresh, Unpasteurized Cider Manufacturers, Summary of Results; Inspection Findings, Harvesting Practices
(12) Fox, Nicols; "Spoiled: The Dangerous Truth About a Food Chain Gone Haywire," Basic Books, New York, NY, 1997
(13) FDA: Report of 1997 Inspections of Fresh, Unpasteurized Cider Manufacturers, Summary of Results; Inspection Findings; Labeling,
(14) FDA: Report of 1997 Inspections of Fresh, Unpasteurized Cider Manufacturers, Summary of Results; Analysis of Inspectional Findings, The Typical Poor Operation section