FDA Guidance on Juice HACCP

Background

On July 8, 1998, the Food and Drug Administration (FDA) released a regulation within the Federal Register (63 FR 37030) that necessitated a warning tag on any juice which was not been treated to reign in, minimize, or obliterate any potential disease-causing microorganisms present (the “juice labeling rule”). For the purpose of this document, juice or any constituent elements of a beverage described in 21 CFR 120.1(a) are included. Any juice or juice ingredient that has not undergone a process that reduces pathogens by one million-fold (in order to have a 5-log decrease in the relevant pathogenic microbe) must display a warning label in accordance with 21 CFR 101.17(g). Labeling may not be a reliable method for protecting public safety, so a warning label was used as a precautionary measure until the Hazard Analysis and Critical Control Point (HACCP) regulations for juice could be finalized and applied.

On January 19, 2001, the FDA announced a conclusion in the Federal Register that imposing Hazard Analysis and Critical Control Points (HACCP) principles on the manufacture of any form of juice or juice elements for consumable drinks had to be put into action (the ‘juice HACCP rule‘). Fruit juice made at a shop that only sells it directly to customers does not have to meet HACCP regulations. The juice HACCP regulation follows the same goal of the juice labeling rule – ensuring a decrease of 5 log orders of the relevant pathogenic microorganisms. Under § 120.24(a), juice processors must put measures in place to ensure a significant reduction.

After the release of the regulation regarding fruit juice labeling, the FDA developed a more comprehensive idea of how to efficiently eliminate bacteria by a 5 log reduction, as stated in the explanation of the standards of the juice Hazard Analysis and Critical Control Points Clause.

Purpose of this Guidance

This document is intended to give advice to any juice processors who are not yet regulated by the HACCP rule concerning juice (such as smaller and very small processors who have until January 21, 2003 and January 20, 2004, respectively for following this rule) who are reducing the amount of pathogens by 5 logs in order to become exempt from the need for a warning label. This document serves as a source for instructions for vendors in stores who are not governed by the juice HACCP rule and are striving to reach a 5-log pathogen reduction to be exempted from the necessity of providing a warning label. The FDA suggests that food processors adhere to the 5-log pathogen reduction treatments given in this document as it reflects the FDA’s present scientific understanding. This notice updates the directions given on setting standards for reducing pathogens in juice labeling in the ruling, as well as in the “Warning and Notice Statement: Labeling of Juice Products Small Entity Compliance Guide” (Ref.1) since they no longer reflect the current ideas of the FDA.

FDA Recommendations

The Food and Drug Administration (FDA)’s current expertise on the most effective procedure to reduce the likelihood of pathogen contamination (a 5-log pathogen reduction) is derived from listening to public meetings, opinions, comments on the proposed juice HACCP rule (63 FR 20450), and advice gleaned from the National Advisory Committee on Microbiological Criteria for Food (NACMCF) (Refs. 2 and 3). In order to ensure the juice processors are meeting the 5-log pathogen reduction that is believed to be correct according to current research, Table 1 displays a comparison of the FDA’s suggestions from the past and present to achieve the same reduction. The following questions and answers provide additional guidance in terms of FDA’s current recommendations for the 5-log reduction:

At what stage of the procedure should the 5-log pathogen reduction process be used?

According to current scientific understanding, the FDA proposed that the destruction of harmful organisms and the packing of the final product should be done in one place under the supervision of a single organization. This firm must follow Good Manufacturing Practices and the packing process should occur right before or right after the destruction. This recommendation is for both citrus and non-citrus juices. GAPs and CGMPs are suggested to be carried out during farming and harvesting stages, however, they should not be factored into the 5-log pathogen reduction total. This suggestion has been thoroughly outlined in the juice HACCP guide (66 FR 6138 at 6166).

Question: What should be treated?

The Food and Drug Administration suggests that processors of juice employ methods that can specifically target any microorganisms that may be living on, or within, the fruit or vegetables that are undergoing processing. For the majority of items, it is necessary to apply treatments to the juice once it has been extracted. Only in the case of citrus juices, effective disinfection of the citrus fruit might involve interaction with all kinds of germs and bacteria, so processors may view this as having achieved the five-log pathogenic decrease. If a surface treatment is used to reduce pathogens by five orders of magnitude, the FDA suggests using it on undamaged and higher quality fruit that was picked off of the tree, and that has been cleaned. The FDA has determined that undamaged citrus fruit picked from the tree can be considered “culled” for the purpose of adhering to the juice HACCP regulation, despite there being no formal USDA standard for choice or higher quality. This recommendation is further explained within the contents of the juice HACCP rule, located in the Federal Register volume 66, issue 6138, beginning on page 6171.

Summary

Processors of all sizes, including those that are very small, must keep meeting the standards for juice labeling established in 21 CFR 120.1(b), even if their juices are not treated in such a way as to reduce pathogens by a 5-log. Under the juice HACCP legislation (21 CFR Part 120), all other juice processors must use HACCP principles in their production operations and make sure their HACCP plan involves measures that reduce pathogens by a factor of five. The FDA does not currently believe that following the instructions given in the guidelines for juice labelling will fully eliminate potential pathogens. Hence, juice producers asserting immunity from the demand for a warning label as suggested by 21 CFR 101.17(g)(7)’s 5-log reduction of pathogens ought to reflect on the guidelines in this guidance.

On August 31, 2001, the Food and Drug Administration (FDA) released a guide titled “The Juice HACCP Regulation: Questions and Answers” which was created to give more information about the HACCP rule for juice and advice on how to achieve a 5-log reduction in pathogens. The Food and Drug Administration plans to provide further material related to the document in question and answer form, which processors may find beneficial. Additionally, FDA intends to issue new guidance documents, such as the “Guidance for Industry: Juice HACCP Hazards and Control Guide” and “Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices.”

QUESTIONS & ANSWERS

A. Applicability

Is fruit nectar covered by the regulation?

Nectar is a commonly termed name in the United States and worldwide commerce pertaining to a thinned down juice drink that can contain either fruit juice or mash, water, and possibly sweetener. So, nectar is not governed by Part 120 since it is a drink that contains juice. The ingredient that is present as puree or juice in that nectar is restrained by the rule stated in §120.1(a).

Is coconut milk and/or water covered by the regulation?

Yes. Coconut is classified as a fruit, and anything taken out of it, e.g. water or milk, is seen as juice and is therefore subject to government control (check out 58 FR 2892 at 2910, January 6, 1993 and 63 FR 20450 at 20451, April 24, 1998).

Is juice used in alcoholic beverages (e.g., wines, alcoholic cider) covered under the regulation?

It depends. Any juice that has not been fermented and has been used to alter the taste or sweetness of a drinks, like wine or cider, and in the completed beverage, maintains its color, taste and nutrition (§120.1(a)) is subject to the rule. The law does not apply to juice that is transformed through fermentation into an alcoholic drink to the point where it is no longer recognizable as juice when the process is complete. (This was commented on in 58 FR 2897 at 2899; §101.3(k).

B. Implementation Dates

If one juice processor makes a concentrate before the applicable effective date and stores it for a period of time, and a second juice processor processes the concentrate into juice after the applicable effective date, which processor is required to comply with the regulation?

The second juicing machine must abide by the law (§120.1(a)).

C. Sanitation Standard Operating Procedures (SSOPs)

Are office toilets included in the mandatory SSOP for maintenance of such facilities?

It depends. The processor must decide the best way to control any potential risks that may arise from office staff having access to the restroom in a processing area, or processing staff being able to use the toilet facilities in an office. The SSOP procedures should encompass both the workplace toilets and toilets which are used in the processing area (as per §120.6(a)(4)).

D. Hazard Analysis

Should a processor incorporate the receipt of raw ingredients into a juice HACCP plan?

If a processor finds that receiving the raw ingredients is a Key Control Point, then their HACCP plan should contain a set of critical limits, potential corrective actions (optional), methods of observation, paperwork logging procedures, and verification steps associated with the CCP (§120.8(b)).

How extensive does the hazard analysis have to be?

The degree of a danger examination relies upon the sort of item, the cycle included, and the amount and kind of potential dangers and dangers that are presumed to occur. It is necessary to determine all potential risks in the hazard evaluation process, whether they happen inside or outside the production area, including any potential risks that may happen prior to, during, or after harvest (§120.8).

Where can I find more information on conducting a hazard analysis?

If you are looking to learn more about performing a hazard analysis, consult the National Advisory Committee on Microbiological Criteria for Foods’ (NACMCF) publication, “Hazard Analysis and Critical Control Point Principles and Applications Guidelines,” which is in the Journal of Food Protection, Vol. 61, No. 9, pp. Between 1998 and 1259, the Juice Alliance developed a program called “Juice HACCP Training Curriculum” and the FDA created a guidebook titled “Juice HACCP Hazards and Controls Guide”.

Does the industry have to have original scientific reports (papers) available to substantiate its hazard analysis decisions?

The processor is not obligated to maintain the initial research documents. Processors should have at the ready any data which is not easy for them to get to and that can be used for their own purposes and to help inspectors.

Can similar products such as pulp free orange juice and orange juice with extra pulp share the same hazard analysis and HACCP plan?

Yes. Products with similar attributes can use the same hazard analysis and HACCP plans if the food hazards, CCPs, critical limits, control measures and documentation are essentially identical, with any discrepancies in the plan or its implementation applied separately to each product or method.

In the example provided, the inclusion of pulp in orange juice could alter the amount of time needed to pasteurize it in order to eliminate any pathogenic microorganisms. If this is the case, then the HACCP plan would have to include both critical limits for both types of juice, one for the orange juice that contains pulp and one for the orange juice that does not.

Each processor should assess their own products and procedures to decide if the resemblances and distinctions necessitate a unique risk assessment and HACCP plan or if the products and methods can use the same assessment and plan (or its parts).

E. HACCP Plan

How should added ingredients in a product considered to be 100 percent juice according to the “Percent Juice Labeling” regulation (21 CFR 101.30) be taken into account in the product’s HACCP plan?

Substances such as 100 % orange juice with added calcium are counted as a form of “juice” according to §120.1(a), and regulated accordingly. As part of the hazard analysis for the juice, producers should examine all substances which have been incorporated into the juice (as outlined in §120.7(d)). If the processor makes the conclusion that potential risks are probable to be caused by the ingredients, measures to deal with such hazards must be part of the product’s HACCP program as per §120.7(e). An example of something that should be included in any HACCP plan is control measures to guarantee that any ingredients like soy protein, preservatives like sulfites that can cause allergies/intolerances, or other items that could lead to serious hypersensitivity reactions are stated on the label.

How many critical control points (CCPs) should there be in a HACCP plan?

Only the number of Critical Control Points (CCPs) required for the hazards that are identified for a certain product should be included in the Hazard Analysis and Critical Control Point (HACCP) plan.