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January 24, 2000 Dockets Management Branch (HFA-305) Re Docket No. 97N-0511 Dear Sir or Madam: Current Systems for Thermal Processing IDFA does not support mandatory HACCP for juice products from concentrates or beverages that use juice as an ingredient which are processed by the dairy industry. Although concern about the safety of fresh juices and related products is warranted, mandatory HACCP for all juice products is not necessary. The dairy industry utilizes its fluid milk processing systems to produce juices from concentrates and juice drink products. These systems include both food safety and quality components such as pasteurization, Good Manufacturing Practices (GMPs) and other programs mandated by FDA and the National Conference on Interstate Milk Shipments (NCIMS) through the Pasteurized Milk Ordinance (PMO) (FDA, 1995). The milk industry has a long established history of safe production of dairy and juice products and as a result there is high consumer confidence in these products. These comments are submitted on behalf of the International Dairy Foods Association (IDFA), and its constituent organizations, the Milk Industry Foundation, the International Ice Cream Association, and the National Cheese Institute. The approximately 850 member companies of these associations operate more than 1550 processing and manufacturing plants, which account for 85% of dairy products consumed in the United States. IDFA's members produce approximately 10% of all juice and juice drinks and 30% of the total orange juice manufactured from concentrate in the U.S. Dairy processors have historically applied the strict regulations mandated for dairy products to the processing of drinks made from juice and juice concentrates. Current systems include pasteurization and programs outlined by NCIMS and GMPs as stated in the Code of Federal Regulation, 21 CFR Part 110. The PMO mandates specific requirements for temperature controls, recording instruments, equipment design, testing and inspections for pasteurization. The following is an overview of high temperature, short time (HTST) pasteurization used by the majority of dairy processors for juice. The residence time of the product in the inclined holding tube is determined by the timing device. Temperature records (charts) are maintained in agreement with the indicating thermometer, which must have an accuracy of ± 0.5°F. If the temperature of the product does not meet the mandated pasteurization temperature, the product is diverted back to the constant level tank via the flow diversion valve. Pasteurization temperatures and times are automatically recorded by the record controller, which also activates the flow diversion valve when necessary. Pasteurized product is pumped upwards past a vacuum break that prevents cross-contamination with unpasteurized product. To ensure proper settings, FDA inspectors verify and seal the timing device and recorder controller to ensure proper holding time. These requirements are also described in Milk Pasteurization Controls and Tests (FDA, 1998). Time/temperature requirements for the pasteurization of milk are found in the PMO and 21 CFR 131.3:
1If the dairy ingredient has a fat content of 10% or more, or if it contains added sweeteners, the specified temperature shall be increased by 5°F. 2Additional pasteurization temperatures are provided by the PMO, 1995. Processing measures employed by the dairy industry are more than adequate to assure the elimination of pathogens in juice drinks. Specifically, the higher acidity of juices and juice drinks results in higher lethality during pasteurization (Banwart, 1989). Unlike milk, which focuses on the elimination of pathogens, the targets of pasteurization for fruit juice in the past have been the inactivation of enzymes and reduction in spoilage organisms (Fellows, 1996). Application of 5-log Reduction IDFA interprets the proposed rule to mean that a 5-log reduction in pathogens may occur at any step in the production of juice and juice beverages. As long as the juice ingredients have been subjected to the required reduction, either before or after blending, the product would be safe. This reduction should not necessarily have to occur immediately prior to final packaging. Juice ingredients used by dairies to manufacture juice beverages generally receive a 5-log reduction in pathogens by the supplier. Pasteurization at the dairy facility often occurs in addition to this 5-log reduction and therefore would not be subject to the mandatory HACCP program proposed by this regulation. Percentage Juice IDFA believes that the proposed rule should include a minimum percent juice for which this rule will apply. Minute percentages of juice do not pose a health threat particularly when the concept of hurdle technology is applied to the food. It is IDFA's position that the proposed regulations should not apply to products containing low levels of juice when GMPs are employed in combination with preservatives, temperature, pH, and/or pasteurization. Full-strength juices should be the target of the proposed rule due to their link to outbreaks of foodborne illness. Mandatory HACCP and a 5-log reduction in pathogens would be burdensome and unnecessary for processors manufacturing drinks with low levels of juice and discourage the incorporation of small amounts of juice to enhance products. IDFA would invite the opportunity to discuss with FDA the concept of a minimum percent juice exemption. IDFA appreciates the opportunity to comment on the proposed regulation and would welcome the opportunity to discuss these issues. We would be glad to answer any questions or provide any additional information. Respectfully submitted, Cary Frye References Banwart, G. J. 1989. Control of microorganisms by destruction, ch. 12. Basic Food Microbiology, 2nd ed. Van Nostrand Reinhold, New York. Fellows, P. J. 1996. Pasteurization, ch. 10. Food Processing Technology: Principles and Practice. Woodhead Publishing, Ltd., Cambridge. Food and Drug Administration. 1995. Grade "A" Pasteurized Milk Ordinance, 1995 Revision. U.S. Department of Health and Human Services. Food and Drug Administration. 1998. Milk Pasteurization Controls and Tests, 7th ed. Division of Human Resource Development, State Training Branch. |
