Guidance for Industry: Questions and Answers on Juice HACCP Regulation September 2001

GUIDANCE DOCUMENT

• Issued by: Human Foods Program

See additional Questions & Answers on the Juice HACCP Regulation (September 4, 2003)

(The regulation definitions are included as Appendix 1)

Table of Contents

• A. Coverage  
• B. Retail Exemption
• C. Relationship to CGMP's  
• D. The Juice Hazard Analysis
• E. Control Measures 
• F. The 5-log Reduction Performance Standard
• G. Control Measures for Chemical and Physical Hazards
• H. Records 
• I. Training 
• J. Imports and Exports
• K. Labeling Questions  
• Appendix 1--Definitions

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A. Coverage

1. What types of juice and juice products are covered by the regulation?

The regulation applies to juice sold as such or used as an ingredient in beverages. Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree. Juice produced by a person who operates a retail establishment as defined in § 120.3(e) are not covered by the regulation.

The regulation requires that processors apply HACCP principles if they make juice or juice concentrates for subsequent beverage use. Any processor making a product that could be labeled as 100 percent juice or a concentrate of that juice for subsequent beverage use must apply HACCP principles. For beverages containing less than 100 percent juice, only the juice ingredient must be made applying HACCP principles.

2. If I pasteurize my juice, do I need to comply with the regulation?

Yes. All juice processors (except retail processors as defined in the regulation) must comply with part 120 for each type of juice they produce.

3. Does this regulation cover fruit and vegetable purees?

The regulation applies to products sold as juice or used as an ingredient in beverages, including fruit and vegetable purees that are used in juices and beverages.

4. If my juice is sold only within my state, do I need to comply with the new regulation?

Yes. This regulation applies equally to juices produced and sold within the same state as well as juices sold in interstate commerce.

5. When do I need to comply with the juice HACCP regulation?

FDA encourages all juice processors to begin to comply with the regulation as soon as possible. The effective date is January 22, 2002. However, if your firm meets the definition for a small business, the effective date is January 21, 2003. If your firm meets the definition of a very small business, the effective date is January 20, 2004.

6. What are the definitions of a small business and a very small business?

Small businesses employ fewer than 500 persons (§120.1(b)(1)). Very small businesses must meet one of the following three criteria: annual sales of less than $500,000, total annual sales greater than $500,000 but total food sales less than $50,000, or operations that employ fewer than an average of 100 full-time equivalent employees and sell fewer than 100,000 units of juice in the United States (§120.1(b)(2)). The size of the business is determined by the magnitude of the corporate operation, not of the business unit.

7. I am a dairy processor who purchases pasteurized apple juice concentrate to make a 5% apple juice beverage and a 15% apple juice beverage. Am I required to comply with the juice HACCP regulation, including the 5-log reduction?

Because you are not making juice as defined by § 120.1(a), you are not required to produce your juice beverage under a HACCP system, although it is highly recommended. However, the juice ingredient (i.e., the pasteurized apple juice concentrate) must have been made under a HACCP program (including compliance with § 120.24).

8. I make a carbonated beverage that contains juice. Am I required to comply with the regulation?

As discussed in the response to question 7, because the carbonated beverage is not "juice" as defined by the regulation, you are not required to produce your carbonated beverage under a HACCP system. However, the juice ingredient of the carbonated beverage must have been made under a HACCP program.

9. I buy pasteurized orange juice concentrate (made under HACCP) and repack the concentrate into large volume bag-in-box containers that I sell to retail businesses to be used in an orange juice dispenser where it is mixed with water and dispensed to the consumer. Do I have to also comply with the regulation?

Yes. Each processor (including the repacker), except the retail processor, must do a hazard analysis and determine whether there are any hazards that are reasonably likely to occur during its process. If a processor identifies any hazards as reasonably likely to occur, it must have a HACCP plan to address those hazards. Because the juice beverage made from the orange juice dispenser is produced at a retail establishment, the seller of that juice is not a processor subject to the regulation. The retail establishment should comply with applicable provisions in the Food Code.

10. Are non-beverage foods that contain juice as an ingredient, e.g., a fruit flavored candy, required to be produced under a HACCP system?

No. The juice HACCP regulation applies to the processing of juice that is sold either as juice or sold for use as a beverage ingredient. Thus, a fruit flavored candy that contains juice as an ingredient is not required to be produced under a HACCP system.

11. Are food ingredients other than juice that are derived from fruit, e.g., citrus oil, required to be produced under a HACCP system?

No, the juice HACCP regulation applies only to the aqueous extract of fruits and vegetables that is sold either as juice or for use as an ingredient in beverages and not to other fruit or vegetable by-products such as citrus oil.

12. Would pulp from a fruit or vegetable used to make a juice or diluted juice beverage be considered juice under the juice HACCP regulation?

Yes. As noted, fruit and vegetable purees used as a juice ingredient are considered "juice" under the regulation. Pulp (i.e., pressed edible fruit or vegetable matter) is often a part of the aqueous liquid stream expressed or extracted from fruits and vegetables (e.g., citrus juice) and is comparable to puree except that it may not undergo the same degree of maceration. Pulp in a juice or a diluted juice beverage is considered juice or a juice ingredient; with a diluted juice beverage, processors are only required to comply with part 120 when making the juice ingredient (e.g., the pulp).

13. Are coffee and tea covered under the regulation?

No. Coffee and tea are infusions produced from dried ingredients and have traditionally not been considered to be juices. Thus, they are not covered under the regulation.

14. Would juice concentrates intended for uses such as flavors or sweeteners in foods other than beverages be subject to the regulation?

Juice concentrates intended for use as flavors, sweeteners, or similar uses in products that are not beverages are not subject to the regulation. However, because there may be problems segregating product used in beverages from that used in other foods, prudent juice concentrate processors should consider implementing HACCP for all of their juice products, not just those products that will be made into juice or used in beverages.

B. Retail Exemption

15. If a retailer decides to pasteurize his apple cider, does he need to have a HACCP system?

Retail producers of juices are not covered by the regulation and would not be required to establish a HACCP system regardless of whether they pasteurize their products.

A retail establishment is an operation that only provides juice directly to consumers. "Provides" includes storing, preparing, packaging, serving, and vending. A retail establishment does not include an establishment that sells or distributes juice to other business entities as well as directly to consumers.

FDA's Food Code provides guidance to retail producers for making safe products.

16. Does the regulation cover apple cider that I make from my own apples and sell over the internet directly to consumers? What about apple cider that I make from my own apples and sell at a farmers market?

If you make cider from your own apples (or apples that you have purchased) and only sell it directly to consumers (e.g., internet sales, farmers markets), you are considered a retailer and thus, your cider does not need to be processed under a HACCP system.

17. If I hire someone to make cider from my apples and I sell this cider at my roadside stand, is this juice producer required to have a HACCP system?

Yes. Only retail establishments are exempt from the regulation. Under the regulation, a retail establishment stores, prepares, packages, serves, and vends its product exclusively and directly to consumers. If someone else processes juice for a retail establishment, that processor is required to operate under HACCP principles.

18. Company A processes juice in a central kitchen and sells the juice to consumers from its own retail outlets. Is Company A's central kitchen considered a retail establishment? Are Company A's retail outlets considered retail establishments?

Company A's central kitchen is not a retail establishment that is exempt from the regulation because it does not sell juice directly to consumers at that location. However, Company A's retail outlets are retail establishments under part 120, if they sell juice directly to consumers and do not sell juice to other business entities (i.e., retail outlets owned by another company).

19. Company B processes juice in a central kitchen that sells juice directly to consumers from its central kitchen as well as supplying its retail outlets. Is the central kitchen a retail establishment? Are Company B's outlets retail establishments?

Company B's central kitchen is a retail establishment under part 120, because it (1) sells juice directly to consumers and (2) does not sell juice to other business entities (i.e., it provides juice only to the retail establishments it owns). If the retail outlets owned by Company B sell juice directly to consumers, but not to other business entities, they are also retail establishments under part 120. FDA encourages central kitchens that are retail establishments under the rule to establish a HACCP system in the processing of juice.

20. If Company C processes juice in a central kitchen that sells juice directly to consumers from its central kitchen and from its retail outlets, but also sells juice to other business entities, is the central kitchen a retail establishment?

Even though Company C sells juice directly to consumers at its central kitchen, the central kitchen is not a retail establishment for purposes of part 120 because it sells juice to business entities that it does not own.

C. Relationship to CGMP's

21. Do FDA's "Current Good Manufacturing Practices" (CGMP) regulations in 21 CFR Part 110 apply to firms that are subject to the juice HACCP regulation? Does compliance by these firms with the juice HACCP regulation replace the need to comply with the CGMP regulations?

Firms covered by the juice HACCP regulation are still subject to the CGMP regulations in Part 110. In fact, CGMP's are an essential foundation for a successful HACCP system.

D. The Juice Hazard Analysis

22. What is a hazard analysis?

The hazard analysis is an evaluation of potential microbiological, chemical, and physical hazards associated with a particular product and process and is used to determine which hazards are reasonably likely to occur and, if they occur, how they can best be controlled. The regulation requires that the hazard analysis be written.

23. Who should conduct the hazard analysis?

The regulation requires that a trained individual, whether an employee or consultant, conduct the written hazard analysis that juice processors (except retail processors) are required to have for their process.

24. What is a "hazard that is reasonably likely to occur?"

A food hazard that is reasonably likely to occur is defined in § 120.7(a)(2) as one for which a prudent processor would establish controls to reduce to acceptable levels, prevent, or eliminate the hazard because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that, in the absence of those controls, the food hazard will occur in the particular type of product being processed.

A potential hazard that has a severe, acute public health impact (e.g., injury caused by ingestion of glass fragments) and that presents a significant risk, even at an extremely low frequency of occurrence, should be identified as a hazard that is reasonably likely to occur. A hazard that requires long-term (chronic) exposure to cause harm would need to occur at a higher frequency to be identified as a hazard that is reasonably likely to occur. The mycotoxin, patulin, which can occur at high levels in apple juice made from damaged, moldy or rotten apples, is an example of a chronic exposure hazard that could occur at such a frequency that it may need to be controlled through a HACCP plan if drops are used to make juice or if apples are stored inappropriately prior to use for juice production.

25. What is the best way to begin a hazard analysis?

FDA believes that carrying out the five preliminary steps as outlined by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will assist processors in conducting a hazard analysis, as well as in other HACCP functions. These are:

• Assemble a HACCP team
• Describe the food and its distribution
• Identify the intended use and consumers of the food
• Develop a flow diagram that describes the process
• Verify the flow diagram

(See "Hazard Analysis and Critical Control Point Principles and Application Guidelines," Journal of Food Protection, Vol. 61, No. 6, pp. 762-775).

Although FDA is not specifically requiring that juice processors use the preliminary steps, these steps will aid them in focusing on their specific product and process.

Flow diagrams that identify each significant step in the process are particularly helpful in conducting a hazard analysis, by facilitating determination as to whether a hazard may be introduced or controlled at each process point.

26. How do I conduct a hazard analysis?

You must do the following in a written hazard analysis (see § 120.7(a)):

27. What is a control measure?

A control measure is any action or activity to prevent, reduce to acceptable levels, or eliminate a hazard (§ 120.3(c)). Control measures are further discussed in the next section.

28. What is a critical control point?

A critical control point (CCP) is a point, step, or procedure in a food process at which a control measure can be applied and at which control is essential to reduce an identified food hazard to an acceptable level (§ 120.3(d)).

E. Control Measures

29. When am I required to implement a HACCP control measure?

You are required to implement a HACCP control measure if you determine in your hazard analysis that a food hazard (e.g., a microbial pathogen, potentially hazardous levels of patulin, glass shards) is reasonably likely to occur in a juice product you produce.

30. What are some examples of HACCP control measures?

Examples of control measures include thermal processing of juice and culling produce to eliminate visibly moldy, rotten, or damaged fruit.

31. If a grower implements FDA's "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables," also referred to as FDA's Good Agricultural Practices (GAP) guidance document, is it considered a HACCP control measure?

No. However, juice processors are encouraged to work with growers of the produce they use to produce juice to evaluate and modify agricultural practices consistent with FDA's GAP guidance.

32. If I sell juice in bulk to company X for final processing and packaging of juice, who is responsible for determining whether HACCP controls for chemical and physical hazards are needed for the juice?

Both firms are responsible for ensuring that the products they make are safe. Both you, the first processor, and company X who is packaging the juice must conduct a hazard analysis and have a written HACCP plan for all hazards that are reasonably likely to occur. You are the primary processor and are responsible for controlling hazards that are reasonably likely to occur from the raw materials you use and from your processing facility (e.g., patulin, lead) in your HACCP plan. Subsequent processors may no longer need to identify these hazards as reasonably likely to occur, because you, the primary processor, have established measures for controlling these hazards. However, there may be other chemical and physical hazards that are reasonably likely to occur during subsequent processing (e.g., glass) that company X must control in their HACCP plan.

33. If I sell juice in bulk to company X for final processing and packaging of a diluted juice product, who is responsible for determining whether HACCP controls for chemical and physical hazards are needed for the juice?

As in the response to the previous question, both firms are responsible for ensuring that the products they make are safe. However, only juice processors must comply with the juice HACCP regulation. Therefore, you must conduct a hazard analysis and determine whether there are chemical, physical, and microbial hazards that are reasonably likely to occur. You are responsible for controlling in your HACCP plan all hazards that are reasonably likely to occur. As a processor of a diluted juice beverage, company X is not a juice processor as defined by the HACCP regulation, and thus, is not required to have a HACCP system. However, company X must ensure that the juice ingredient used in the diluted juice beverage complies with part 120.

F. The 5-log Reduction Performance Standard

34. What is the 5-log pathogen reduction performance standard?

Performance standard requirements in general are goals that processors should achieve but provide flexibility on how processors accomplish them. The 5-log pathogen reduction performance standard required by the regulation means that you must treat your juice (or citrus fruit if using surface treatments) using a process that will achieve at least a 100,000 fold decrease in the number of microorganisms (see next question). Juice processors must apply controls (e.g., heat, UV light) to achieve the 5-log reduction required by the regulation.

35. Does a 5-log reduction in the bacterial plate count (i.e., aerobic plate count or total plate count) of a juice sample meet the performance standard requirement?

No. Under the rule, the 5-log reduction must be targeted to the "pertinent pathogen." The "pertinent pathogen" is the most resistant microorganism of public health concern that may occur in the juice. The pertinent pathogen may vary with the type of juice and the type of treatment used, though typically it would be Salmonella or Escherichia coli O157:H7.

36. What times and temperatures should I use to pasteurize my juice?

Precise times and temperatures depend on the type of juice you make and your process. Scientific literature is an excellent source of information. (See "Thermal Inactivation of Stationary-Phase and Acid-Adapted Escherichia coli 0157:H7, Salmonella, and Listeria moncytogenes in Fruit Juices," by Alejandro S. Mazzotta, Journal of Food Protection, 1998, Vol. 64, No. 3, 2001, pages 315-320.)

37. How can I achieve a 5-log reduction without pasteurizing the product?

You can achieve a 5-log reduction by using control measures that have been shown to be effective in reducing the number of microorganisms. You can use one control measure that has been shown to reduce the pertinent microorganism by at least 5-log (e.g., high pressure) or a combination of control measures that have a cumulative effect of a 5-log reduction. Citrus juice processors may use surface treatments of the fruit to contribute towards attaining the 5-log reduction. All other juice processors must apply the 5-log process to the juice.

38. May I do the 5-log reduction on the fruit before extracting the juice?

Producers of juice other than citrus must apply the 5-log reduction treatment on the extracted juice. Citrus processors have the option of treating the surface of the fruit because it is unlikely that pathogens will enter sound, intact citrus fruit under current industry processing practices. If citrus juice processors use surface treatments to achieve all or part of the 5-log reduction, they must conduct tests to verify that the surface treatment is effective. Process verification procedures are found in § 120.25. (Note that the 5-log reduction treatment must occur within a single processing facility. See question 40.)

39. May cleaning (i.e., washing of the produce) and culling (i.e., removal of damaged produce) be included among the control measures used to meet the 5-log reduction requirement?

No. All produce used for making juice must be cleaned and culled prior to extraction or, in the case of surface treated citrus fruit, prior to control measures used to meet the 5-log reduction requirement. For surface treated citrus, culled fruit is undamaged, tree-picked fruit.

40. May juice be treated in one processing facility to achieve part of a 5-log pathogen reduction, i.e., a 2-log reduction, and then transported to another facility for treatment to achieve the remainder of the 5-log reduction?

No. The entire 5-log reduction must be accomplished within a single production facility operating under CGMP's.

41. May I use fruit that has fallen from the tree to the ground (i.e., drops) to make juice?

You may use drops if the fruit is cleaned and culled (i.e., damaged fruit removed) and the 5-log treatment is applied to the extracted juice. Citrus juice manufacturers using surface treatments must use undamaged tree-picked fruit.

42. I make shelf-stable juice that receives over a 10,000-log reduction. Am I still required to have microbial control measures in a HACCP plan? What about juice concentrates that are processed with over a 100-log reduction?

If you make thermally processed juice that is shelf stable or thermally processed juice concentrate, you are not required to include control measures in the HACCP plan for achieving the 5-log pathogen reduction. However, you must include a copy of the thermal process in your hazard analysis.

43. If I use a heat treatment process on my juice, can I assume that the process meets the 5-log pathogen reduction requirement of the HACCP regulation?

No. Except for processors of thermally processed shelf stable juices and juice concentrates, juice processors must establish and meet critical limits to ensure that the heat process is effective and consistently fulfills the 5-log reduction standard. Critical limits are the maximum or minimum values to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.

44. If a juice product is treated by a means other than heat to meet the 5-log pathogen reduction requirement, is FDA approval required for the treatment?

A food additive regulation is required for treatments that use irradiation (e.g., pulsed light, UV light, ionizing radiation) and may be required for the use of certain chemicals. You are responsible for ensuring that all treatments, regardless of compliance with food additive regulations, achieve the 5-log pathogen reduction for your juice and process.

45. Does each processor handling a juice have to do a 5-log reduction?

Each processor handling the juice (except retail processors) must conduct a hazard analysis to determine whether there are hazards, including microbial hazards, that are reasonably likely to occur. Each processor must have controls for microbial hazards. This may be assurances that the juice will be given the required 5-log treatment at another processing location.

46. If I produce a consumer frozen juice concentrate from a higher concentrated juice that comes from another location via tanker truck (whether or not under direct company control), do I need to redo the 5-log reduction?

Yes. As discussed in the response to question 40, the 5-log reduction must be conducted in the same processing facility where final product packaging of the consumer concentrate occurs (§ 120.24(c)). Tanker trucks may be a source of contamination because it is particularly difficult to adequately sanitize them between shipments.

47. In the past, some processors have added a small amount of untreated juice to pasteurized juice for flavor enhancement. May I do this?

No. All ingredients of the juice must have received a 5-log reduction. Pathogens may be present in untreated juice and could contaminate the treated juice.

48. Can a flavor essence recovered during a juice concentration operation be added back to a juice after the juice has received a 5-log pathogen reduction treatment without requiring an additional 5-log treatment?

If you can demonstrate that the recovery process used to capture the flavor essence achieved the 5-log reduction, you can add the essence to the treated juice and you will have complied with § 120.24. Otherwise, the flavor essence must undergo a 5-log reduction process before it is added to treated juice or the juice with the flavor essence must undergo a 5-log reduction to comply with § 120.24. If the essence is not treated along with the juice, you must ensure that the process by which the essence is added to the juice does not allow for contamination.

G. Control Measures for Chemical and Physical Hazards

49. Are there any mandatory HACCP control measures for chemical hazards such as patulin or lead?

HACCP controls for specific chemical hazards such as patulin and lead are required when a processor determines that the presence of the chemical in the juice is a hazard that is reasonably likely to occur. In conducting a hazard analysis, a juice processor must consider all potential hazards and determine whether any of these hazards are reasonably likely to occur. If a hazard is reasonably likely to occur, a processor must include controls for that hazard in its HACCP plan.

50. I am a dairy processor who also makes juice using my milk processing equipment. Should I be concerned about milk residues (allergenic proteins) being present in the juice? What are the controls to prevent possible allergen cross-contamination (cross-contact) in this situation, and should these controls be included in my HACCP Plan??

Yes, when using milk processing equipment to process juice, cross-contact of milk protein into the juice is a concern. Allergens, such as milk, soy (soy milk), or egg (egg nog) should be considered chemical hazards that need to be addressed in your hazard analysis. Controls to prevent cross contact may include a rigorous sanitation regime in between a production run of milk products and a production of juice products. In addition to sanitation, production scheduling can have a large impact on minimizing cross-contact from shared equipment. Processors should try to schedule all non-allergen containing products first, followed by allergen containing products, with a full clean-up before again running a non-allergen product. Depending on the outcome of the hazard analysis, sanitation and production scheduling may be managed through SSOP's or as part of the HACCP plan.

See Compliance Policy Guide 555.250 for the list of common food allergens recognized by the Agency.

51. Are HACCP control measures required for any specific physical hazards such as glass?

HACCP controls for specific physical hazards, e.g., glass, are required under the juice HACCP regulation when the processor determines in its hazard analysis that the specific physical hazard is reasonably likely to occur in the juice (see the response to question 49 above).

H. Records

52. What types of records will I be required to maintain to document my HACCP system?

You must maintain records pertaining to:

• Sanitation standard operating procedures monitoring and corrective actions
• The hazard analysis
• The HACCP plan
• Operational records such as records of process monitoring, corrective actions, verification, and validation activities
• Importer verification

General requirements and documentation requirements for records are included in §§ 120.12 (b) and (c) of the regulation.

53. How long must I keep the required HACCP records?

A processor of perishable or refrigerated juices and an importer of such juices must retain required HACCP records at the processing facility (processors) or at the importer's place of business in the United States (importers) for at least 1 year after the date that the products were prepared. A processor of frozen, preserved, or shelf stable products and an importer of such products must retain the required records at the processing facility (processors) or at the importer's place of business in the United States (importers) for 2 years or the shelf life of the product, whichever is greater, after the date that the products were prepared.

54. Are juice processors required to make all of their records related to juice available to FDA inspectors?

Only those records that are specifically required under § 120.12 must be made available for review and copying by FDA at reasonable times. These records are listed in the response to question 52.

55. What records are necessary to show that consumer complaints have been reviewed?

You must make a record that documents that you have performed a review of the consumer complaints that you have received. However, you are not required to show consumer complaints to FDA.

I. Training

56. What specialized training is needed to establish a HACCP system?

Certain key aspects of HACCP require training in HACCP principles. Individuals who perform certain functions related to the development of the hazard analysis and HACCP plan, and the verification, validation, corrective action, and record review requirements of the regulation must be trained (see § 120.13(a)). Training must be equivalent to a standardized curriculum that FDA recognizes as adequate. Job experience may qualify an individual to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum. The Juice Alliance is in the process of establishing a standardized curriculum, and FDA has been providing input to the Alliance's effort.

57. Does the person(s) doing the key aspects of the HACCP system need to be an employee(s) of the juice processing firm?

No, the trained individual need not be an employee of the processor. However, regardless of who the trained individual is, the firm processing the juice is ultimately responsible for the safety of the juice and for compliance with part 120.

J. Imports and Exports

58. Does imported juice that will only be used as an ingredient in beverages have to be produced in compliance with part 120?

Yes. All imported juice, even if the juice is for use as an ingredient in a beverage, must comply with the juice HACCP regulation.

59. What are the responsibilities of juice importers under the juice HACCP regulation?

In brief, importers of juice either must ensure that all juice they offer for entry into the U.S. has been processed in compliance with Part 120, or import such juice from a country that has an appropriate memorandum of understanding (MOU) with the U.S. In addition, importers must maintain records that document the performance and results of the affirmative steps taken to demonstrate compliance with the regulation. Requirements for importers of juice are set out in § 120.14 of the regulation.

60. Does the regulation apply to juices and juice concentrates produced in the U.S. and intended for export either as bulk shipment or in consumer packages?

Processors of juice intended for export must comply with the juice regulation unless the juice at issue satisfies all of the following conditions:

• Meets the specifications of the foreign purchaser;
• Conforms to the laws of the importing country;
• Is labeled on the outside of the shipping package that the product is intended for export; and
• Is not sold or offered for sale in domestic commerce.

61. Are there any established memoranda of understanding (MOUs) for juice? How does someone go about establishing an MOU?

There are currently no established MOUs for juice HACCP. Normally, the process is started by a letter to FDA from a foreign government requesting initiation of the MOU process. Letters to establish MOUs for juice should be submitted to:

Mr. Charles W. Cooper
Director, International Activities
HFS-585
Center for Food Safety and Applied Nutrition
Food and Drug Administration
200 C St., S.W.
Washington, DC 20204

Examples of FDA MOUs can be found at the Food and Drug Administration Cooperative Agreements web page.

K. Labeling Questions

62. If I want to label my product as pasteurized, what criteria do I need to meet?

Pasteurization is a heat treatment sufficient to destroy pathogens. Therefore, to be labeled as "pasteurized," a juice must be heat treated to destroy pathogens.

63. May I use the warning label statement on my products in lieu of implementing a HACCP system?

Generally speaking, use of the juice label warning statement is not an alternative to compliance with the HACCP regulation. All juice that is not appropriately treated to achieve a 5-log reduction in the pertinent pathogen is required to comply with the warning statement regulation; in the case of HACCP, all juice processors are required to comply with the regulation according to the staggered effectiveness dates (§ 120.1(b)) except retail establishments as defined by the regulation. Juice required to be produced under a HACCP system that is not so produced will be considered adulterated.

64. How can I label my apple cider that is processed using ultraviolet (UV) light? Can I label it as "pasteurized" or "UV treated?" Can it be called "fresh?"

As discussed above, pasteurization is a heat treatment sufficient to destroy pathogens. Therefore, use of the term "pasteurized" on products that have been treated with UV light to attain the 5-log reduction is misleading and the product would be considered to be misbranded under section 403(a) of the Food, Drug, and Cosmetic Act. Possible terms you may use that would convey to consumers that the product has been treated with UV to control pathogens are "treated with UV light to control pathogens," "treated with UV light to control harmful bacteria," or "UV treated." Juice processed using UV light cannot be labeled "fresh.

Appendix 1- Definitions

(a) Cleaned means washed with water of adequate sanitary quality.

(b) Control means to prevent, eliminate, or reduce.

(c) Control measure means any action or activity to prevent, reduce to acceptable levels, or eliminate a hazard.

(d) Critical control point means a point, step, or procedure in a food process at which a control measure can be applied and at which control is essential to reduce an identified food hazard to an acceptable level.

(e) Critical limit means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.

(f) Culled means separation of damaged fruit from undamaged fruit. For processors of citrus juices using treatments to fruit surfaces to comply with § 120.24, culled means undamaged, tree-picked fruit that is U.S. Department of Agriculture choice or higher quality.

(g) Food hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

(h) Importer means either the U.S. owner or consignee at the time of entry of a food product into the United States, or the U.S. agent or representative of the foreign owner or consignee at the time of entry into the United States. The importer is responsible for ensuring that goods being offered for entry into the United States are in compliance with all applicable laws. For the purposes of this definition, the importer is ordinarily not the custom house broker, the freight forwarder, the carrier, or the steamship representative.

(i) Monitor means to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification.

(j) (1) Processing means activities that are directly related to the production of juice products. (2) For purposes of this part, processing does not include:

• (i) Harvesting, picking, or transporting raw agricultural ingredients of juice products, without otherwise engaging in processing and
• (ii) The operation of a retail establishment.

(k) Processor means any person engaged in commercial, custom, or institutional processing of juice products, either in the United States or in a foreign country, including any person engaged in the processing of juice products that are intended for use in market or consumer tests.

(l) Retail establishment is an operation that provides juice directly to the consumers and does not include an establishment that sells or distributes juice to other business entities as well as directly to consumers. "Provides" includes storing, preparing, packaging, serving, and vending.

(m) Shall is used to state mandatory requirements.

(n) Shelf-stable product means a product that is hermetically sealed and, when stored at room temperature, should not demonstrate any microbial growth.

(o) Should is used to state recommended or advisory procedures or to identify recommended equipment.

(p) Validation means that element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the identified food hazards.

(q) Verification means those activities, other than monitoring, that establish the validity of the HACCP plan and that the system is operating according to the plan.

See additional Questions & Answers on the Juice HACCP Regulation (September 2, 2003).

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Related Information

• Juice Guidance Documents & Regulatory Information

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Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.