Guidance for Industry: Exemptions from the Warning Label Requirement for Juice - Recommendations for Effectively Achieving a 5-Log Pathogen Reduction; Final Guidance
Contains Nonbinding Recommendations
October 7, 2002
Comments and suggestions regarding this document may be submitted at any time to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should be identified with the Docket Number 01D-0493. For questions regarding this document contact Jennifer A. Burnham, (301) 436-2030.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Contains Nonbinding Recommendations
Guidance for Industry
Exemptions from the Warning Label Requirement for Juice - Recommendations for Effectively Achieving a 5-Log Pathogen Reduction
In the Federal Register of July 8, 1998 (63 FR 37030), the Food and Drug Administration (FDA) published a final rule requiring a warning label on any juice that has not been processed to prevent, reduce, or eliminate pathogenic microorganisms that may be present (the "juice labeling rule"). In this guidance document, juice means any juice or juice ingredient in a beverage, as defined by 21 CFR 120.1(a). Under 21 CFR 101.17(g), any juice or juice ingredient that is not processed to reduce pathogens by 100,000-fold (i.e., attain a 5-log reduction in the pertinent pathogenic microorganism) must bear a warning label. Because labeling may have limited effectiveness (i.e., it must be read and be understood), the warning label was intended to provide a measure of public safety until final Hazard Analysis and Critical Control Point (HACCP) regulations for juice could be established and implemented.
In the Federal Register of January 19, 2001 (66 FR 6138), FDA published a final rule requiring the application of HACCP principles to the processing of any juice or juice ingredient in a beverage (the "juice HACCP rule"). Juice produced in a retail establishment, i.e., a facility that produces juice that is only sold directly to consumers, is exempt from the HACCP requirements. Like the juice labeling rule, the juice HACCP rule utilizes the standard of a 5-log reduction in the pertinent pathogenic microorganism. Specifically, under § 120.24(a), juice processors must establish control measures that will produce such a reduction.
After the publication of the juice labeling rule, FDA's scientific understanding of how to attain effectively a 5-log pathogen reduction evolved, as discussed in the preamble and as reflected in the requirements of the juice HACCP rule.
Purpose of this Guidance
The purpose of this guidance document is to provide guidance to those juice processors not yet subject to the juice HACCP rule (e.g., small and very small processors who are not subject to the juice HACCP rule until January 21, 2003 and January 20, 2004, respectively) who are performing a 5-log pathogen reduction to attain exemption from the warning label requirement. This guidance document also provides guidance to processors at retail who are not subject to the juice HACCP rule and who are performing a 5-log pathogen reduction to attain exemption from the warning label requirement. FDA encourages those processors to operate consistently with this guidance in terms of 5-log pathogen reduction treatments because this guidance is based upon FDA's current scientific knowledge. In part, this guidance supercedes the previous 5-log pathogen reduction guidance in the juice labeling rule and FDA's guidance document, "Warning and Notice Statement: Labeling of Juice Products Small Entity Compliance Guide" (the "small entity compliance guide") (Ref. 1), because these documents no longer reflect FDA's current thinking.
FDA's current scientific understanding of how to attain effectively a 5-log pathogen reduction is based on information obtained from public meetings, discussions, comments to the juice HACCP proposed rule (63 FR 20450), and recommendations from the National Advisory Committee on Microbiological Criteria for Food (NACMCF) (Refs. 2 and 3). To assist juice processors in attaining a 5-log pathogen reduction consistent with current scientific knowledge, Table 1 compares FDA's previous and current recommendations for achieving the 5-log pathogen reduction. The following questions and answers provide additional guidance in terms of FDA's current recommendations for the 5-log reduction:
Question: When in the process should the 5-log pathogen reduction treatment be applied?
Answer: Based upon current scientific understanding, FDA recommends that the 5-log pathogen reduction and final product packaging occur under one firm's control, in a single production facility that is operating under current Good Manufacturing Practices (CGMPs) and immediately before or immediately after packing. This recommendation is for both citrus and non-citrus juices. Although good agricultural practices (GAPs) and CGMPs at the farming and harvesting stages are encouraged, they should not be counted towards the 5-log pathogen reduction. The basis for this recommendation is discussed in more detail in the juice HACCP rule (66 FR 6138 at 6166).
Question: What should be treated?
Answer: FDA recommends that juice processors use treatments that directly contact all pathogens that may be present in or on the fruit or vegetables being processed. For most products, this means that the treatments should be performed on the juice after it is expressed. For citrus juices only, effective surface treatment of the citrus fruit may constitute direct contact with all pathogens, and thus, processors may consider counting such treatment toward the 5-log pathogen reduction. If surface treatments are used on citrus fruits to achieve the 5-log pathogen reduction, FDA recommends that the treatment be applied to undamaged, tree-picked fruit (i.e., culled fruit that is U.S. Department of Agriculture choice or higher quality), that has been cleaned. (Note: There is no current USDA standard for choice or higher quality. FDA will consider undamaged tree-picked citrus fruit to meet the definition of "culled" for purposes of compliance with the juice HACCP regulation). The basis for this recommendation is discussed in more detail in the juice HACCP rule (66 FR 6138 at 6171).
Small and very small processors (as defined in 21 CFR 120.1(b)) who do not treat their juice to achieve the 5-log pathogen reduction should continue to comply with the juice labeling rule. All other juice processors are now required by the juice HACCP regulation (21 CFR Part 120) to apply HACCP principles to their processing operations and to have, in any resulting HACCP plan, measures to achieve a 5-log reduction in pathogens. Based upon FDA's current knowledge, processing juice in accordance with the recommendations in the small entity compliance guide for the juice labeling rule may not reduce pathogens to an acceptable level. Therefore, juice processors claiming exemption from the warning label requirement on the basis of the 5-log pathogen reduction provision of 21 CFR 101.17(g)(7) should consider the principles in this guidance.
On August 31, 2001, FDA published a guidance document, "The Juice HACCP Regulation: Questions and Answers" to provide additional information on the juice HACCP rule, including assistance in achieving a 5-log pathogen reduction. As a follow-up to that document, FDA plans to publish additional information in question and answer format that processors may find useful, as well as additional guidance documents including, "Guidance for Industry: Juice HACCP Hazards and Control Guide" and "Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices." All documents will be available electronically.
|Previous Regulatory Requirements/Guidance for Achieving a 5-Log Pathogen Reduction||Current Regulatory Requirements/Guidance for Achieving a 5-Log Pathogen Reduction|
|5-log reduction must occur in target pathogen for a period of at least as long as the shelf-life of the product stored under normal or moderate abuse conditions (juice labeling rule, 21 CFR 101.17(g)(7)(i)).||No change (21 CFR 101.17(g)(7)(i); 21 CFR 120.24(a)).|
|5-log pathogen reduction may include measures taken during farming, harvesting, or processing over which the processor has control and which are effective (Small Entity Compliance Guide).||5-log pathogen reduction and final packaging should occur under one firm's control and within a single production facility. Any reduction of pathogens based upon the application of GAPs and CGMPs in farming and harvesting is encouraged but should not be counted towards 5-log pathogen reduction.|
|5-log pathogen reduction may be cumulative (Small Entity Compliance Guide).||No change (preamble to the juice HACCP rule).|
|No prior guidance.||5-log pathogen reduction should use treatments that directly contact all pathogens that may be present. For citrus fruit, surface treatment may be counted toward 5-log pathogen reduction following cleaning and culling. For non-citrus fruit, treatment should be applied to the expressed juice.|
- FDA, DHHS, "Guidance for Industry: Warning and Notice Statement: Labeling of Juice Products Small Entity Compliance Guide," September 18, 1998.
- FSIS, USDA, "National Advisory Committee on Microbiological Criteria for Food," 64 FR 63281-63282, November 19, 1999.
- NACMCF, "National Advisory Committee on Microbiological Criteria for Food, Meeting on Fresh Citrus Juice; Transcript of Proceedings," December 8 to 9, 1999, public meeting.
The above guidance document supercedes the previous version dated December 21, 2001.