Hazard analysis and critical control point (HACCP) systems (21 CFR 120.1-120.25)

351 Food and Drug Administration, HHS § 120.3 § 119.1 Dietary supplements con taining ephedrine alkaloids. Dietary supplements containing ephedrine alkaloids present an unrea sonable risk of illness or injury under conditions of use recommended or sug gested in the labeling, or if no condi tions of use are recommended or sug gested in the labeling, under ordinary conditions of use. Therefore, dietary supplements containing ephedrine alkaloids are adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act. [69 FR 6853, Feb. 11, 2004] PART 120—HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS Subpart A—General Provisions Sec. 120.1 Applicability. 120.3 Definitions. 120.5 Current good manufacturing practice. 120.6 Sanitation standard operating proce dures. 120.7 Hazard analysis. 120.8 Hazard Analysis and Critical Control Point (HACCP) plan. 120.9 Legal basis. 120.10 Corrective actions. 120.11 Verification and validation. 120.12 Records. 120.13 Training. 120.14 Application of requirements to im ported products. Subpart B—Pathogen Reduction 120.20 General. 120.24 Process controls. 120.25 Process verification for certain proc essors. AUTHORITY: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 381, 393; 42 U.S.C. 241, 242l, 264. SOURCE: 66 FR 6197, Jan. 19, 2001, unless otherwise noted. Subpart A—General Provisions § 120.1 Applicability. (a) Any juice sold as such or used as an ingredient in beverages shall be processed in accordance with the re quirements of this part. Juice means the aqueous liquid expressed or ex tracted from one or more fruits or vegetables, purees of the edible por tions of one or more fruits or vegeta bles, 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 ingredi ents, is or has been shipped in inter state commerce (as defined in section 201(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321(b)). Raw ag ricultural 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 very small businesses that have either total annual sales of less than $500,000, or if their total annual sales are greater than $500,000 but their total food sales are less than $50,000; or the person claiming this exemption employed fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of juice were sold in the United States, the regula tions are binding on January 20, 2004. § 120.3 Definitions. The definitions of terms in section 201 of the Federal Food, Drug, and Cos metic Act, § 101.9(j)(18)(vi), and part 110 of this chapter are applicable to such terms when used in this part, except where redefined in this part. The fol lowing definitions shall also apply: (a) Cleaned means washed with water of adequate sanitary quality. (b) Control means to prevent, elimi nate, or reduce. (c) Control measure means any action or activity to prevent, reduce to ac ceptable levels, or eliminate a hazard. (d) Critical control point means a point, step, or procedure in a food proc ess at which a control measure can be applied and at which control is essen tial to reduce an identified food hazard to an acceptable level. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00361 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 352 21 CFR Ch. I (4–1–15 Edition) § 120.5 (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 dam aged fruit from undamaged fruit. For processors of citrus juices using treat ments 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 rea sonably likely to cause illness or in jury 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 representa tive 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 represent ative. (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, proc essing does not include: (i) Harvesting, picking, or trans porting raw agricultural ingredients of juice products, without otherwise en gaging in processing; and (ii) The operation of a retail estab lishment. (k) Processor means any person en gaged in commercial, custom, or insti tutional processing of juice products, either in the United States or in a for eign country, including any person en gaged in the processing of juice prod ucts that are intended for use in mar ket or consumer tests. (l) Retail establishment is an operation that provides juice directly to the con sumers and does not include an estab lishment that sells or distributes juice to other business entities as well as di rectly to consumers. ‘‘Provides’’ in cludes storing, preparing, packaging, serving, and vending. (m) Shall is used to state mandatory requirements. (n) Shelf-stable product means a prod uct that is hermetically sealed and, when stored at room temperature, should not demonstrate any microbial growth. (o) Should is used to state rec ommended or advisory procedures or to identify recommended equipment. (p) Validation means that element of verification focused on collecting and evaluating scientific and technical in formation to determine whether the HACCP plan, when properly imple mented, will effectively control the identified food hazards. (q) Verification means those activi ties, other than monitoring, that es tablish the validity of the HACCP plan and that the system is operating ac cording to the plan. § 120.5 Current good manufacturing practice. Part 110 of this chapter applies in de termining whether the facilities, meth ods, practices, and controls used to process juice are safe, and whether the food has been processed under sanitary conditions. § 120.6 Sanitation standard operating procedures. (a) Sanitation controls. 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 manufac ture 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, VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00362 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 353 Food and Drug Administration, HHS § 120.7 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, sani tizing agents, condensate, and other chemical, physical, and biological con taminants; (6) Proper labeling, storage, and use of toxic compounds; (7) Control of employee health condi tions that could result in the micro biological contamination of food, food packaging materials, and food contact surfaces; and (8) Exclusion of pests from the food plant. (b) Monitoring. The processor shall monitor the conditions and practices during processing with sufficient fre quency to ensure, at a minimum, con formance with those conditions and practices specified in part 110 of this chapter that are appropriate both to the plant and to the food being proc essed. Each processor shall correct, in a timely manner, those conditions and practices that are not met. (c) Records. Each processor shall maintain SSOP records that, at a min imum, document the monitoring and corrections prescribed by paragraph (b) of this section. These records are sub ject to the recordkeeping requirements of § 120.12. (d) Relationship to Hazard Analysis and Critical Control Point (HACCP) plan. Sanitation standard operating proce dure controls may be included in the HACCP plan required under § 120.8(b). However, to the extent that they are implemented in accordance with this section, they need not be included in the HACCP plan. § 120.7 Hazard analysis. (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 proc essor would establish controls because experience, illness data, scientific re ports, or other information provide a basis to conclude that there is a rea sonable 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 haz ard occurs; (3) Identification of the control meas ures that the processor can apply to control the food hazards identified as reasonably likely to occur in paragraph (a)(2) of this section; (4) Review of the current process to determine whether modifications are necessary; and (5) Identification of critical control points. (b) The hazard analysis shall include food hazards that can be introduced both within and outside the processing plant environment, including food haz ards that can occur before, during, and after harvest. The hazard analysis shall be developed by an individual or indi viduals who have been trained in ac cordance with § 120.13 and shall be sub ject to the recordkeeping requirements of § 120.12. (c) In evaluating what food hazards are reasonably likely to occur, consid eration should be given, at a minimum, to the following: (1) Microbiological contamination; (2) Parasites; (3) Chemical contamination; (4) Unlawful pesticides residues; (5) Decomposition in food where a food hazard has been associated with decomposition; (6) Natural toxins; (7) Unapproved use of food or color additives; (8) Presence of undeclared ingredi ents that may be allergens; and (9) Physical hazards. (d) Processors should evaluate prod uct ingredients, processing procedures, VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00363 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 354 21 CFR Ch. I (4–1–15 Edition) § 120.8 packaging, storage, and intended use; facility and equipment function and design; and plant sanitation, including employee hygiene, to determine the po tential effect of each on the safety of the finished food for the intended con sumer. (e) HACCP plans for juice need not address the food hazards associated with microorganisms and microbial toxins that are controlled by the re quirements of part 113 or part 114 of this chapter. A HACCP plan for such juice shall address any other food haz ards that are reasonably likely to occur. § 120.8 Hazard Analysis and Critical Control Point (HACCP) plan. (a) HACCP plan. Each processor shall have and implement a written HACCP plan whenever a hazard analysis re veals one or more food hazards that are reasonably likely to occur during proc essing, 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 record keeping requirements of § 120.12. A HACCP plan shall be specific to: (1) Each location where juice is proc essed 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 to gether, if the food hazards, critical con trol points, critical limits, and proce dures required to be identified and per formed 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. (b) The contents of the HACCP plan. The HACCP plan shall, at a minimum: (1) List all food hazards that are rea sonably likely to occur as identified in accordance with § 120.7, and that thus must be controlled for each type of product; (2) List the critical control points for each of the identified food hazards that is reasonably likely to occur, including as appropriate: (i) Critical control points designed to control food hazards that are reason ably likely to occur and could be intro duced inside the processing plant envi ronment; and (ii) Critical control points designed to control food hazards introduced out side the processing plant environment, including food hazards that occur be fore, during, and after harvest; (3) List the critical limits that shall be met at each of the critical control points; (4) List the procedures, and the fre quency with which they are to be per formed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits; (5) Include any corrective action plans that have been developed in ac cordance with § 120.10(a), and that are to be followed in response to deviations from critical limits at critical control points; (6) List the validation and verification procedures, and the fre quency with which they are to be per formed, that the processor will use in accordance with § 120.11; and (7) Provide for a recordkeeping sys tem that documents the monitoring of the critical control points in accord ance with § 120.12. The records shall contain the actual values and observa tions obtained during monitoring. (c) Sanitation. Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with § 120.6, they are not required to be included in the HACCP plan. § 120.9 Legal basis. Failure of a processor to have and to implement a Hazard Analysis and Crit ical Control Point (HACCP) system that complies with §§ 120.6, 120.7, and 120.8, or otherwise to operate in accord ance with the requirements of this part, shall render the juice products of that processor adulterated under sec tion 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 de termined through an evaluation of the processor’s overall implementation of its HACCP system. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00364 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 355 Food and Drug Administration, HHS § 120.11 § 120.10 Corrective actions. Whenever a deviation from a critical limit occurs, a processor shall take corrective action by following the pro cedures 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 accord ance with § 120.8(b)(5), by which proc essors predetermine the corrective ac tions 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 other wise adulterated as a result of the devi ation; and (2) The cause of the deviation is cor rected. (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 require ments of paragraphs (b)(2) and (b)(3) of this section are met; (2) Perform or obtain a review to de termine the acceptability of the af fected product for distribution. The re view shall be performed by an indi vidual or individuals who have ade quate training or experience to perform such review; (3) Take corrective action, when nec essary, with respect to the affected product to ensure that no product en ters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; (4) Take corrective action, when nec essary, to correct the cause of the devi ation; and (5) Perform or obtain timely verification in accordance with § 120.11, by an individual or individuals who have been trained in accordance with § 120.13, to determine whether modifica tion of the HACCP plan is required to reduce the risk of recurrence of the de viation, and to modify the HACCP plan as necessary. (c) All corrective actions taken in ac cordance with this section shall be fully documented in records that are subject to verification in accordance with § 120.11(a)(1)(iv)(B) and the record keeping requirements of § 120.12. § 120.11 Verification and validation. (a) Verification. Each processor shall verify that the Hazard Analysis and Critical Control Point (HACCP) system is being implemented according to de sign. (1) Verification activities shall in clude: (i) A review of any consumer com plaints 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 moni toring instruments; (iii) At the option of the processor, the performance of periodic end-prod uct 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 test ing 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 con trol 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 re view shall occur within 1 week (7 days) of the day that the records are made; (B) The taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appro priate corrective actions were taken in accordance with § 120.10. This review shall occur within 1 week (7 days) of the day that the records are made; and (C) The calibrating of any process monitoring instruments used at crit ical control points and the performance of any periodic end-product or in-proc ess testing that is part of the proc essor’s verification activities. The pur pose of these reviews shall be, at a min imum, to ensure that the records are VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00365 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 356 21 CFR Ch. I (4–1–15 Edition) § 120.12 complete and that these activities oc curred in accordance with the proc essor’s written procedures. These re views shall occur within a reasonable time after the records are made; and (v) The following of procedures in § 120.10 whenever any verification pro cedure, including the review of con sumer complaints, establishes the need to take a corrective action; and (vi) Additional process verification if required by § 120.25. (2) Records that document the cali bration of process monitoring instru ments, in accordance with paragraph (a)(1)(iv)(B) of this section, and the per formance of any periodic end-product and in-process testing, in accordance with paragraph (a)(1)(iv)(C) of this sec tion, are subject to the recordkeeping requirements of § 120.12. (b) Validation of the HACCP plan. Each processor shall validate that the HACCP plan is adequate to control food hazards that are reasonably likely to occur; this validation shall occur at least once within 12 months after im plementation and at least annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP plan in any way. Such changes may in clude changes in the following: Raw materials or source of raw materials; product formulation; processing meth ods or systems, including computers and their software; packaging; finished product distribution systems; or the in tended use or consumers of the finished product. The validation shall be per formed 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. The HACCP plan shall be modified im mediately whenever a validation re veals that the plan is no longer ade quate to fully meet the requirements of this part. (c) Validation of the hazard analysis. Whenever a juice processor has no HACCP plan because a hazard analysis has revealed no food hazards that are reasonably likely to occur, the proc essor shall reassess the adequacy of that hazard analysis whenever there are any changes in the process that could reasonably affect whether a food hazard exists. Such changes may in clude changes in the following: Raw materials or source of raw materials; product formulation; processing meth ods or systems, including computers and their software; packaging; finished product distribution systems; or the in tended use or intended consumers of the finished product. The validation of the hazard analysis shall be performed by an individual or individuals who have been trained in accordance with § 120.13, and, records documenting the validation shall be subject to the rec ordkeeping requirements of § 120.12. § 120.12 Records. (a) Required records. Each processor shall maintain the following records documenting the processor’s Hazard Analysis and Critical Control Point (HACCP) system: (1) Records documenting the imple mentation of the sanitation standard operating procedures (SSOP’s) (see § 120.6); (2) The written hazard analysis re quired by § 120.7; (3) The written HACCP plan required by § 120.8; (4) Records documenting the ongoing application of the HACCP plan that in clude: (i) Monitoring of critical control points and their critical limits, includ ing the recording of actual times, tem peratures, or other measurements, as prescribed in the HACCP plan; and (ii) Corrective actions, including all actions taken in response to a devi ation; and (5) Records documenting verification of the HACCP system and validation of the HACCP plan or hazard analysis, as appropriate. (b) General requirements. All records required by this part shall include: (1) The name of the processor or im porter and the location of the processor or importer, if the processor or im porter 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)(3), and (a)(5) of this section need not include the time; (3) The signature or initials of the person performing the operation or cre ating the record; and VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00366 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 357 Food and Drug Administration, HHS § 120.13 (4) Where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed. The records shall contain the actual values and observa tions obtained during monitoring. (c) Documentation. (1) The records in paragraphs (a)(2) and (a)(3) of this sec tion shall be signed and dated by the most responsible individual onsite at the processing facility or by a higher level official of the processor. These signatures shall signify that these records have been accepted by the firm. (2) The records in paragraphs (a)(2) and (a)(3) of this section shall be signed and dated: (i) Upon initial acceptance; (ii) Upon any modification; and (iii) Upon verification and validation in accordance with § 120.11. (d) Record retention. (1) All records re quired by this part shall be retained at the processing facility or at the im porter’s place of business in the United States for, in the case of perishable or refrigerated juices, at least 1 year after the date that such products were pre pared, and for, in the case of frozen, preserved, or shelf stable products, 2 years or the shelf life of the product, whichever is greater, after the date that the products were prepared. (2) Offsite storage of processing records required by paragraphs (a)(1) and (a)(4) of this section is permitted after 6 months following the date that the monitoring occurred, if such records can be retrieved and provided onsite within 24 hours of request for of ficial review. Electronic records are considered to be onsite if they are ac cessible from an onsite location and comply with paragraph (g) of this sec tion. (3) If the processing facility is closed for a prolonged period between sea sonal packs, the records may be trans ferred to some other reasonably acces sible location at the end of the sea sonal pack but shall be immediately returned to the processing facility for official review upon request. (e) Official review. All records re quired by this part shall be available for review and copying at reasonable times. (f) Public disclosure. (1) All records re quired by this part are not available for public disclosure unless they have been previously disclosed to the public, as defined in § 20.81 of this chapter, or unless they relate to a product or in gredient that has been abandoned and no longer represent a trade secret or confidential commercial or financial information as defined in § 20.61 of this chapter. (2) Records required to be maintained by this part are subject to disclosure to the extent that they are otherwise pub licly available, or that disclosure could not reasonably be expected to cause a competitive hardship, such as generic type HACCP plans that reflect stand ard industry practices. (g) Records maintained on computers. The maintenance of computerized records, in accordance with part 11 of this chapter, is acceptable. § 120.13 Training. (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 meas ures, as required by § 120.7. (2) Developing a Hazard Analysis and Critical Control Point (HACCP) plan that is appropriate for a specific proc essor, in order to meet the require ments 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 ac tivities specified in §§ 120.11(b) and (c); and 120.7; (4) Performing the record review re quired by § 120.11(a)(1)(iv). (b) The individual performing the functions listed in paragraph (a) of this section shall have successfully com pleted training in the application of HACCP principles to juice processing at least equivalent to that received under standardized curriculum recog nized as adequate by the Food and Drug Administration, or shall be other wise qualified through job experience to perform these functions. Job experi ence may qualify an individual to per form these functions if such experience VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00367 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 358 21 CFR Ch. I (4–1–15 Edition) § 120.14 has provided knowledge at least equiv alent to that provided through the standardized curriculum. The trained individual need not be an employee of the processor. § 120.14 Application of requirements to imported products. This section sets forth specific re quirements for imported juice. (a) Importer requirements. Every im porter of juice shall either: (1) Obtain the juice from a country that has an active memorandum of un derstanding (MOU) or similar agree ment with the Food and Drug Adminis tration, that covers the food and docu ments the equivalency or compliance of the inspection system of the foreign country with the U.S. system, accu rately reflects the relationship be tween the signing parties, and is func tioning and enforceable in its entirety; or (2) Have and implement written pro cedures for ensuring that the juice that such importer receives for import into the United States was processed in ac cordance with the requirements of this part. The procedures shall provide, at a minimum: (i) Product specifications that are de signed 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 may include any of the fol lowing: (A) Obtaining from the foreign proc essor the Hazard Analysis and Critical Control Point (HACCP) plan and pre requisite program of the standard oper ating procedure records required by this part that relate to the specific lot of food being offered for import; (B) Obtaining either a continuing or lot specific certificate from an appro priate foreign government inspection authority or competent third party certifying that the imported food has been processed in accordance with the requirements of this part; (C) Regularly inspecting the foreign processor’s facilities to ensure that the imported food is being processed in ac cordance with the requirements of this part; (D) Maintaining on file a copy, in English, of the foreign processor’s haz ard analysis and HACCP plan, and a written guarantee from the foreign processor that the imported food is processed in accordance with the re quirements of this part; (E) Periodically testing the imported food, and maintaining on file a copy, in English, of a written guarantee from the foreign processor that the imported food is processed in accordance with the requirements of this part; or (F) Other such verification measures as appropriate that provide an equiva lent level of assurance of compliance with the requirements of this part. (b) Competent third party. An importer may hire a competent third party to assist with or perform any or all of the verification activities specified in para graph (a)(2) of this section, including writing the importer’s verification pro cedures on the importer’s behalf. (c) Records. The importer shall main tain records, in English, that document the performance and results of the af firmative steps specified in paragraph (a)(2)(ii) of this section. These records shall be subject to the applicable provi sions of § 120.12. (d) Determination of compliance. The importer shall provide evidence that all juice offered for entry into the United States has been processed under conditions that comply with this part. If assurances do not exist that an im ported juice has been processed under conditions that are equivalent to those required of domestic processors under this part, the product will appear to be adulterated and will be denied entry. Subpart B—Pathogen Reduction § 120.20 General. This subpart augments subpart A of this part by setting forth specific re quirements for process controls. § 120.24 Process controls. (a) In order to meet the requirements of subpart A of this part, processors of juice products shall include in their VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00368 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 359 Food and Drug Administration, HHS § 120.25 Hazard Analysis and Critical Control Point (HACCP) plans control measures that will consistently produce, at a minimum, a 5 log (i.e., 105) 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 para graph: (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 in cludes thermal treatment of all ingre dients, provided that the processor in cludes a copy of the thermal process used to achieve shelf-stability or con centration in its written hazard anal ysis required by § 120.7. (b) All juice processors shall meet the requirements of paragraph (a) of this section through treatments that are applied directly to the juice, except that citrus juice processors may use treatments to fruit surfaces, provided that the 5-log reduction process begins after culling and cleaning as defined in § 120.3(a) and (f) and the reduction is ac complished within a single production facility. (c) All juice processors shall meet the requirements of paragraphs (a) and (b) of this section and perform final prod uct packaging within a single produc tion facility operating under current good manufacturing practices. Proc essors claiming an exemption under paragraph (a)(1) or (a)(2) of this section shall also process and perform final product packaging of all juice subject to the claimed exemption within a sin gle production facility operating under current good manufacturing practices. § 120.25 Process verification for cer tain processors. Each juice processor that relies on treatments that do not come into di rect contact with all parts of the juice to achieve the requirements of § 120.24 shall analyze the finished product for biotype I Escherichia coli 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 pro duced 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 con sumers. (b) If the facility is producing more than one type of juice covered by this section, processors shall take subsam ples according to paragraph (a) of this section for each of the covered juice products produced. (c) Processors shall analyze each sub sample for the presence of E. coli by the method entitled ‘‘Analysis for Esch erichia coli in Citrus Juices—Modifica tion of AOAC Official Method 992.30’’ or another method that is at least equiva lent to this method in terms of accu racy, precision, and sensitivity in de tecting E. coli. This method is designed to detect the presence or absence of E. coli in a 20 mL sample of juice (con sisting of two 10 mL subsamples). The method is as follows: (1) Sample size. Total-20 mL of juice; perform analysis using two 10 mL aliquots. (2) Media. Universal Preenrichment Broth (Difco, Detroit, MI), EC Broth (various manufacturers). (3) Method. ColiComplete (AOAC Offi cial Method 992.30—modified). (4) Procedure. Perform the following procedure two times: (i) Aseptically inoculate 10 mL of juice into 90 mL of Universal Preenrichment Broth (Difco) and incu bate at 35 °C for 18 to 24 hours. (ii) Next day, transfer 1 mL of preenriched sample into 10 mL of EC Broth, without durham gas vials. After inoculation, aseptically add a ColiComplete SSD disc into each tube. (iii) Incubate at 44.5 °C for 18 to 24 hours. (iv) Examine the tubes under longwave ultra violet light (366 nm). Fluorescent tubes indicate presence of E. coli. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00369 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 360 21 CFR Ch. I (4–1–15 Edition) Pt. 123 (v) MUG positive and negative con trols should be used as reference in in terpreting fluorescence reactions. Use an E. coli for positive control and 2 neg ative controls—a MUG negative strain and an uninoculated tube media. (d) If either 10 mL subsample is posi tive for E. coli, the 20 mL sample is re corded as positive and the processor shall: (1) Review monitoring records for the control measures to attain the 5-log re duction standard and correct those conditions and practices that are not met. In addition, the processor may choose to test the sample for the pres ence of pathogens of concern. (2) If the review of monitoring records or the additional testing indi cates that the 5-log reduction standard was not achieved (e.g., a sample is found to be positive for the presence of a pathogen or a deviation in the proc ess or its delivery is identified), the processor shall take corrective action as set forth in § 120.10. (e) If two samples in a series of seven tests are positive for E. coli, the control measures to attain the 5-log reduction standard shall be deemed to be inad equate and the processor shall imme diately: (1) Until corrective actions are com pleted, use an alternative process or processes that achieve the 5-log reduc tion after the juice has been expressed; (2) Perform a review of the moni toring records for control measures to attain the 5-log reduction standard. The review shall be sufficiently exten sive to determine that there are no trends towards loss of control; (i) If the conditions and practices are not being met, correct those that do not conform to the HACCP plan; or (ii) If the conditions and practices are being met, the processor shall vali date the HACCP plan in relation to the 5-log reduction standard; and (3) Take corrective action as set forth in § 120.10. Corrective actions shall include ensuring no product en ters commerce that is injurious to health as set forth in § 120.10(a)(1). PART 123—FISH AND FISHERY PRODUCTS Subpart A—General Provisions Sec. 123.3 Definitions. 123.5 Current good manufacturing practice. 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan. 123.7 Corrective actions. 123.8 Verification. 123.9 Records. 123.10 Training. 123.11 Sanitation control procedures. 123.12 Special requirements for imported products. Subpart B—Smoked and Smoke-Flavored Fishery Products 123.15 General. 123.16 Process controls. Subpart C—Raw Molluscan Shellfish 123.20 General. 123.28 Source controls. AUTHORITY: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 381, 393; 42 U.S.C. 241, 241l, 264. SOURCE: 60 FR 65197, Dec. 18, 1995, unless otherwise noted. Subpart A—General Provisions § 123.3 Definitions. The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) and in part 110 of this chapter are ap plicable to such terms when used in this part, except where they are herein redefined. The following definitions shall also apply: (a) Certification number means a unique combination of letters and numbers assigned by a shellfish control authority to a molluscan shellfish processor. (b) Critical control point means a point, step, or procedure in a food proc ess at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels. (c) 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 VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00370 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B