Contains Nonbinding Recommendations
Comments and suggestions regarding this document may be submitted at any time. Submit comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the Docket Number 2004D-0311.
For questions regarding this document, contact Michael E. Kashtock at the Center for Food Safety and Applied Nutrition (CFSAN) at (Tel) (301) 436-2022 (Updated phone: 240-402-2022), (Fax) (301) 436-2651, or email email@example.com.
Additional copies are available from:
Office of Plant and Dairy Foods
Division of Plant Product Safety HFS-305
Center for Food Safety and Applied Nutrition
Food and Drug Administration, 5100 Paint Branch Parkway
College Park, MD 20740
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Guidance for Industry(1)
Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
This guidance addresses the use of ozone to treat apple juice to meet the pathogen reduction requirements of 21 CFR Part 120 "Hazard Analysis and Critical Control Point (HACCP) Systems" (the juice HACCP regulation) and 21 CFR 101.17(g) "Juices that have not been specifically processed to prevent, reduce, or eliminate the presence of pathogens" (the juice labeling regulation).(2)
In the fall of 2003, an outbreak of foodborne cryptosporidiosis occurred in Ohio that resulted in 23 confirmed and 121 probable case-patients. Cryptosporidiosis is a diarrheal illness caused by species of the protozoan parasite Cryptosporidium, e.g., Cryptosporidium parvum. This illness can be severe in healthy individuals, and can be life-threatening in immuno-compromised persons. Apple cider produced at a local orchard that was treated with ozone for pathogen reduction purposes has been epidemiologically implicated as the responsible food by the U.S. Centers for Disease Control and Prevention. In addition, oocysts of Cryptosporidium parvum were present in a container of the implicated apple cider taken from the home of a case patient.
Ozone is a substance that can reduce levels of harmful microorganisms, including pathogenic E. coli strains and Cryptosporidium, in juice. Ozone is approved as a food additive that may be safely used as an antimicrobial agent in the treatment, storage, and processing of certain foods under the conditions of use prescribed in 21 CFR 173.368.(3)
Any treatment, including the use of ozone, used to meet the pathogen reduction requirements of the juice HACCP regulation must be carried out as a "process"(4) that will produce, at a minimum, a 5-log reduction of the pertinent microorganism (the most resistant organism of public health concern that is likely to occur in the juice.),(5) and the treatment process must be validated.(6) Similarly, any treatment used to achieve the pathogen reduction requirements of the juice labeling regulation must be a "process" that will produce at least a 5-log reduction in the pertinent microorganism.(7) FDA has previously advised that this process should be validated.(8)
A processor subject to the juice HACCP regulation would typically address these requirements by identifying a validation study that establishes the efficacy of his process for achieving the 5-log pathogen reduction (21 CFR 120.11 and 120.24), by establishing critical control points (21 CFR 120.8 (b)(2)) and critical limits (21 CFR 120.8 (b)(3)), and by monitoring the process at the critical control points to ensure that the critical limits are met (21 CFR 120.8 (b)(4)). A processor subject to the HACCP regulation is also required to make certain records available to FDA inspectors, including documentation that validates the efficacy of the process for the reduction of the pertinent microorganism, a HACCP plan, and monitoring records (21 CFR 120.12).
A processor subject to the juice labeling regulation is not required to apply HACCP principles to its operations. However, to comply with 21 CFR 101.17(g)(7), the juice must be processed in a manner that will produce, at a minimum, a 5-log reduction in the pertinent microorganism. We would also expect the process to be delivered in a manner that will achieve the required 5-log reduction for the pertinent pathogen, which should include the use of appropriate process controls and monitoring in accord with our "Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food" regulation in 21 CFR 110.80(b)(2).
As noted, the principles of process and validation apply to all treatments to juice, including the use of ozone as an antimicrobial agent. A validation study can establish the specifics of an ozonation process that are necessary to achieve the 5-log reduction. With ozone, the variables may include the total concentration of ozone introduced into the juice, the flow rate of ozone into the batch tank, the treatment time, the appropriate batch volume, and the degree of agitation of the juice, if any, needed to ensure that the ozone is uniformly dispersed in the juice. Compositional factors, such as the amount and type of juice solids present (e.g., sucrose and organic matter) can vary among different apple juice and cider products and may affect the efficacy of a process. A validation study may also establish how these factors need to be controlled to ensure the efficacy of the ozonation process. However, at this time, FDA is not aware of any published scientific study that establishes conditions for ozonating apple juice to achieve a 5-log pathogen reduction for any pathogen.
Therefore, we are advising all processors using (or considering using) ozone for treating apple juice or apple cider to be certain that they comply with the pathogen reduction provisions of the regulation that applies to them, including validation of their process, or implement another means of processing their juice. Processors may consult with a process authority to determine whether a validation study exists that supports their process, and for assistance in establishing processing parameters, e.g., process controls, critical limits, and monitoring procedures. Additional information is also available in our Juice HACCP Hazards and Controls Guidance, First Edition.
Guidance for Processors for the 2004 Cider Season Only
FDA is aware that some small processors have purchased ozone units for processing their juice in the belief that ozone treatment of apple juice had been shown to meet the 5-log pathogen reduction requirements. FDA wishes to minimize disruption of the operations of these processors. However the agency places the highest priority on protecting the public health. Therefore, FDA is providing the following guidance to processors:
- For juice processors whose operations are not "retail establishments" as defined in the juice HACCP regulation (21 CFR 120.3(l)): You are subject to the Juice HACCP regulation which requires that you treat your juice to achieve a 5-log pathogen reduction. Under FDA's regulations, you no longer have the option to sell juice treated with ozone if the treatment has not achieved the 5-log pathogen reduction. However, FDA will consider the exercise of its enforcement discretion and allow you to sell juice treated with ozone for the remainder of the current cider season, i.e., until September 1, 2005, provided that you apply the warning label specified in the juice labeling regulation to your juice offered for sale in packaged form. This policy will allow you to continue to sell your juice, with the appropriate warning label, and provide time for you to procure alternative processing equipment for future cider production if ozone treatment of apple juice has not been demonstrated to achieve the 5-log pathogen reduction requirements by next year's cider season.
- For processors whose operations are "retail establishments" as defined in the juice HACCP regulation (21CFR 120.3(l)): If your business operates in interstate commerce you are subject to the juice labeling regulation. Under that regulation, you have the option of selling juice that is not treated to achieve the 5-log pathogen reduction, e.g., juice treated with ozone using a process that has not been validated to achieve the 5-log pathogen reduction, provided that the juice's label bears the warning statement specified in the juice labeling regulation (see footnote #9). If you are using an ozone treatment that has not been validated to treat your juice, and the label does not bear the required warning statement, you are potentially subject to FDA enforcement action. If your business operates only in intrastate commerce, you are subject to the requirements of your state regulatory authority.
2 The juice HACCP regulation, which covers all non-retail juice processors, requires a processor of juice to evaluate its operations using Hazard Analysis Critical Control Point (HACCP) principles and, if necessary, to develop and implement HACCP systems (i.e., a system of preventive control measures based upon HACCP principles) for its operations. The juice labeling regulation, which covers retail processors of juice, requires that any container of juice that has not been treated to achieve a 5-log reduction in the most resistant pathogen bear a warning label informing consumers of the risk associated with consuming untreated juice.
5 We have recommended in our Juice HACCP Hazards and Controls Guidance, First Edition, that E. coli O157:H7 and Cryptosporidium parvum be considered when determining the pertinent microorganism for apple juice. Whichever microorganism is most resistant to the process to be used, e.g., heat pasteurization, UV light, is the pertinent microorganism for that process. The guidance is available at http://www.cfsan.fda.gov/~dms/juicgu10.html.
6 The juice HACCP final rule requires that each processor validate that the HACCP plan is adequate to control hazards that are reasonably likely to occur (21 CFR 120.11(b).) Except for shelf stable juices and juice concentrates, such validation must establish that the HACCP plan is capable of achieving a 5-log reduction in the pertinent microorganism (21 CFR 120.24).
8 In the juice labeling final rule, we stated that "consistent with customary scientific practices, the method that produces the 5-log reduction should be validated," (63 FR 37029 at 37042; July 8, 1998) and as such, advised any processor subject to the juice labeling regulation that we would expect its process to be supported by a validation study demonstrating its efficacy against the pertinent pathogen, e.g., Cryptosporidium parvum.
9The required warning label reads "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems."
This document supercedes Guidance for Industry: Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes (August 2004)