Title 21 CFR reference

(a) Any juice sold as such or used as an ingredient in beverages shall be processed in accordance with the requirements of this part. 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. The requirements of this part shall apply to any juice regardless of whether the juice, or any of its ingredients, is or has been shipped in interstate commerce (as defined in section 201(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321(b)). Raw agricultural ingredients of juice are not subject to the requirements of this part. Processors should apply existing agency guidance to minimize microbial food safety hazards for fresh fruits and vegetables in handling raw agricultural products. (b) The regulations in this part shall be effective January 22, 2002. However, by its terms, this part is not binding on small and very small businesses until the dates listed in paragraphs (b)(1) and (b)(2) of this section. (1) For small businesses employing fewer than 500 persons the regulations in this part are binding on January 21, 2003. (2) For…

Whenever a deviation from a critical limit occurs, a processor shall take corrective action by following the procedures set forth in paragraph (a) or paragraph (b) of this section. (a) Processors may develop written corrective action plans, which become part of their HACCP plans in accordance with § 120.8(b)(5), by which processors predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that: (1) No product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and (2) The cause of the deviation is corrected. (b) When a deviation from a critical limit occurs, and the processor does not have a corrective action plan that is appropriate for that deviation, the processor shall: (1) Segregate and hold the affected product, at least until the requirements of paragraphs (b)(2) and (b)(3) of this section are met; (2) Perform or obtain a review to determine the acceptability of the affected product for…

Verification.(a) Each processor shall verify that the Hazard Analysis and Critical Control Point (HACCP) system is being implemented according to design. (1) Verification activities shall include: (i) A review of any consumer complaints that have been received by the processor to determine whether such complaints relate to the performance of the HACCP plan or reveal previously unidentified critical control points; (ii) The calibration of process monitoring instruments; (iii) At the option of the processor, the performance of periodic end-product or in-process testing; except that processors of citrus juice that rely in whole or in part on surface treatment of fruit shall perform end-product testing in accordance with § 120.25. (iv) A review, including signing and dating, by an individual who has been trained in accordance with § 120.13, of the records that document: (A) The monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that the records document values that are within the critical limits. This review shall occur within 1 week (7 days) of the day that the records are made; (B)…

Required records.(a) Each processor shall maintain the following records documenting the processor's Hazard Analysis and Critical Control Point (HACCP) system: (1) Records documenting the implementation of the sanitation standard operating procedures (SSOP's) (see § 120.6); (2) The written hazard analysis required by § 120.7; (3) The written HACCP plan required by § 120.8; (4) Records documenting the ongoing application of the HACCP plan that include: (i) Monitoring of critical control points and their critical limits, including the recording of actual times, temperatures, or other measurements, as prescribed in the HACCP plan; and (ii) Corrective actions, including all actions taken in response to a deviation; and (5) Records documenting verification of the HACCP system and validation of the HACCP plan or hazard analysis, as appropriate. General requirements.(b) All records required by this part shall include: (1) The name of the processor or importer and the location of the processor or importer, if the processor or importer has more than one location; (2) The date and time of the activity that the record reflects, except that records required by paragraphs (a)(2),…

(a) Only an individual who has met the requirements of paragraph (b) of this section shall be responsible for the following functions: (1) Developing the hazard analysis, including delineating control measures, as required by § 120.7. (2) Developing a Hazard Analysis and Critical Control Point (HACCP) plan that is appropriate for a specific processor, in order to meet the requirements of § 120.8; (3) Verifying and modifying the HACCP plan in accordance with the corrective action procedures specified in § 120.10(b)(5) and the validation activities specified in §§ 120.11(b) and (c); and 120.7; (4) Performing the record review required by § 120.11(a)(1)(iv). (b) The individual performing the functions listed in paragraph (a) of this section shall have successfully completed training in the application of HACCP principles to juice processing at least equivalent to that received under standardized curriculum recognized as adequate by the Food and Drug Administration, or shall be otherwise qualified through job experience to perform these functions. Job experience may qualify an individual to perform these functions if such experience has provided knowledge at least equivalent to…

This section sets forth specific requirements for imported juice. Importer requirements.(a) Every importer of juice shall either: (1) Obtain the juice from a country that has an active memorandum of understanding (MOU) or similar agreement with the Food and Drug Administration, that covers the food and documents the equivalency or compliance of the inspection system of the foreign country with the U.S. system, accurately reflects the relationship between the signing parties, and is functioning and enforceable in its entirety; or (2) Have and implement written procedures for ensuring that the juice that such importer receives for import into the United States was processed in accordance with the requirements of this part. The procedures shall provide, at a minimum: (i) Product specifications that are designed to ensure that the juice is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act because it may be injurious to health or because it may have been processed under insanitary conditions; and (ii) Affirmative steps to ensure that the products being offered for entry were processed under controls that meet the requirements of this part. These steps…

This subpart augments subpart A of this part by setting forth specific requirements for process controls.

i.e.,5(a) In order to meet the requirements of subpart A of this part, processors of juice products shall include in their Hazard Analysis and Critical Control Point (HACCP) plans control measures that will consistently produce, at a minimum, a 5 log ( 10 ) reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism. For the purposes of this regulation, the “pertinent microorganism” is the most resistant microorganism of public health significance that is likely to occur in the juice. The following juice processors are exempt from this paragraph: (1) A juice processor that is subject to the requirements of part 113 or part 114 of this chapter; and (2) A juice processor using a single thermal processing step sufficient to achieve shelf-stability of the juice or a thermal concentration process that includes thermal treatment of all ingredients, provided that the processor includes a copy of the thermal process used to achieve shelf-stability or concentration in its written hazard analysis required by § 120.7. (b) All juice processors shall meet the requirements of paragraph (a) of…

Escherichia coliEach juice processor that relies on treatments that do not come into direct contact with all parts of the juice to achieve the requirements of § 120.24 shall analyze the finished product for biotype I as follows: (a) One 20 milliliter (mL) sample (consisting of two 10 mL subsamples) for each 1,000 gallons of juice produced shall be sampled each production day. If less than 1,000 gallons of juice is produced per day, the sample must be taken for each 1,000 gallons produced but not less than once every 5 working days that the facility is producing that juice. Each subsample shall be taken by randomly selecting a package of juice ready for distribution to consumers. (b) If the facility is producing more than one type of juice covered by this section, processors shall take subsamples according to paragraph (a) of this section for each of the covered juice products produced. E. coliEscherichia coliE. coli.E. coli(c) Processors shall analyze each subsample for the presence of by the method entitled “Analysis for in Citrus Juices—Modification of AOAC Official Method 992.30” or another method that is at least equivalent to this method in terms of accuracy, precision,…

The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act, § 101.9(j)(18)(vi) of this chapter, and parts 110 and 117 of this chapter are applicable to such terms when used in this part, except that the definitions and terms in parts 110 and 117 do not govern such terms where such terms are redefined in this part and except that the terms facility, hazard, and manufacturing/processing in parts 110 and 117 do not govern such terms where used in this part. The following definitions shall also apply: Cleaned(a) means washed with water of adequate sanitary quality. Control(b) means to prevent, eliminate, or reduce. Control measure(c) means any action or activity to prevent, reduce to acceptable levels, or eliminate a hazard. Critical control point(d) 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. Critical limit(e) 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…

Except as provided by § 117.5(c), parts 110 and 117 of this chapter apply in determining whether the facilities, methods, practices, and controls used to process juice are safe, and whether the food has been processed under sanitary conditions. [80 FR 56167, Sept. 17, 2015]

Sanitation controls.(a) Each processor shall have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing. The SSOP shall address: (1) Safety of the water that comes into contact with food or food contact surfaces or that is used in the manufacture of ice; (2) Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; (3) Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product; (4) Maintenance of hand washing, hand sanitizing, and toilet facilities; (5) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; (6) Proper labeling, storage, and use of toxic compounds; (7) Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food…

(a) Each processor shall develop, or have developed for it, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice processed by that processor and to identify control measures that the processor can apply to control those hazards. The written hazard analysis shall consist of at least the following: (1) Identification of food hazards; (2) An evaluation of each food hazard identified to determine if the hazard is reasonably likely to occur and thus, constitutes a food hazard that must be addressed in the HACCP plan. A food hazard that is reasonably likely to occur is one for which a prudent processor would establish controls 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. This evaluation shall include an assessment of the severity of the illness or injury if the food hazard occurs; (3) Identification of the control measures that the processor can apply to control the food hazards identified as…

HACCP plan.(a) Each processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing, as described in § 120.7. The HACCP plan shall be developed by an individual or individuals who have been trained in accordance with § 120.13 and shall be subject to the recordkeeping requirements of § 120.12. A HACCP plan shall be specific to: (1) Each location where juice is processed by that processor; and (2) Each type of juice processed by the processor. The plan may group types of juice products together, or group types of production methods together, if the food hazards, critical control points, critical limits, and procedures required to be identified and performed by paragraph (b) of this section are essentially identical, provided that any required features of the plan that are unique to a specific product or method are clearly delineated in the plan and are observed in practice. The contents of the HACCP plan.(b) The HACCP plan shall, at a minimum: (1) List all food hazards that are reasonably likely to occur as identified in accordance with § 120.7, and that thus must be…

Failure of a processor to have and to implement a Hazard Analysis and Critical Control Point (HACCP) system that complies with §§ 120.6, 120.7, and 120.8, or otherwise to operate in accordance with the requirements of this part, shall render the juice products of that processor adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Whether a processor's actions are consistent with ensuring the safety of juice will be determined through an evaluation of the processor's overall implementation of its HACCP system.