Fish and fishery products (21 CFR 123.3-123.28)

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 361 Food and Drug Administration, HHS § 123.3 acceptable level the occurrence of the identified food safety hazard. (d) Fish means fresh or saltwater finfish, crustaceans, other forms of aquatic animal life (including, but not limited to, alligator, frog, aquatic tur tle, jellyfish, sea cucumber, and sea ur chin and the roe of such animals) other than birds or mammals, and all mol lusks, where such animal life is in tended for human consumption. (e) Fishery product means any human food product in which fish is a charac terizing ingredient. (f) Food safety hazard means any bio logical, chemical, or physical property that may cause a food to be unsafe for human consumption. (g) Importer means either the U.S. owner or consignee at the time of entry 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, who is respon sible for ensuring that goods being of fered for entry into the United States are in compliance with all laws affect ing the importation. For the purposes of this definition, ordinarily the im porter is not the custom house broker, the freight forwarder, the carrier, or the steamship representative. (h) Molluscan shellfish means any edi ble species of fresh or frozen oysters, clams, mussels, or scallops, or edible portions of such species, except when the product consists entirely of the shucked adductor muscle. (i) Preventive measure means physical, chemical, or other factors that can be used to control an identified food safe ty hazard. (j) Process-monitoring instrument means an instrument or device used to indicate conditions during processing at a critical control point. (k)(1) Processing means, with respect to fish or fishery products: Handling, storing, preparing, heading, evis cerating, shucking, freezing, changing into different market forms, manufac turing, preserving, packing, labeling, dockside unloading, or holding. (2) The regulations in this part do not apply to: (i) Harvesting or transporting fish or fishery products, without otherwise en gaging in processing. (ii) Practices such as heading, evis cerating, or freezing intended solely to prepare a fish for holding on board a harvest vessel. (iii) The operation of a retail estab lishment. (l) Processor means any person en gaged in commercial, custom, or insti tutional processing of fish or fishery products, either in the United States or in a foreign country. A processing in cludes any person engaged in the pro duction of foods that are to be used in market or consumer tests. (m) Scombroid toxin-forming species means tuna, bluefish, mahi mahi, and other species, whether or not in the family Scombridae, in which signifi cant levels of histamine may be pro duced in the fish flesh by decarboxylation of free histidine as a result of exposure of the fish after cap ture to temperatures that permit the growth of mesophilic bacteria. (n) Shall is used to state mandatory requirements. (o) Shellfish control authority means a Federal, State, or foreign agency, or sovereign tribal government, legally responsible for the administration of a program that includes activities such as classification of molluscan shellfish growing areas, enforcement of molluscan shellfish harvesting con trols, and certification of molluscan shellfish processors. (p) Shellstock means raw, in-shell molluscan shellfish. (q) Should is used to state rec ommended or advisory procedures or to identify recommended equipment. (r) Shucked shellfish means molluscan shellfish that have one or both shells removed. (s) Smoked or smoke-flavored fishery products means the finished food pre pared by: (1) Treating fish with salt (sodium chloride), and (2) Subjecting it to the direct action of smoke from burning wood, sawdust, or similar material and/or imparting to it the flavor of smoke by a means such as immersing it in a solution of wood smoke. (t) Tag means a record of harvesting information attached to a container of shellstock by the harvester or proc essor. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00371 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 362 21 CFR Ch. I (4–1–15 Edition) § 123.5 § 123.5 Current good manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities, methods, practices, and controls used to process fish and fishery products are safe, and whether these products have been processed under sanitary condi tions. (b) The purpose of this part is to set forth requirements specific to the proc essing of fish and fishery products. § 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan. (a) Hazard analysis. Every processor shall conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product proc essed by that processor and to identify the preventive measures that the proc essor can apply to control those haz ards. Such food safety hazards can be introduced both within and outside the processing plant environment, includ ing food safety hazards that can occur before, during, and after harvest. A food safety hazard that is reasonably likely to occur is one for which a pru dent processor would establish controls because experience, illness data, sci entific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of fish or fishery product being processed in the absence of those controls. (b) The HACCP plan. Every processor shall have and implement a written HACCP plan whenever a hazard anal ysis reveals one or more food safety hazards that are reasonably likely to occur, as described in paragraph (a) of this section. A HACCP plan shall be specific to: (1) Each location where fish and fish ery products are processed by that processor; and (2) Each kind of fish and fishery prod uct processed by the processor. The plan may group kinds of fish and fish ery products together, or group kinds of production methods together, if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed in paragraph (c) of this section are identical for all fish and fishery prod ucts so grouped or for all production methods so grouped. (c) The contents of the HACCP plan. The HACCP plan shall, at a minimum: (1) List the food safety hazards that are reasonably likely to occur, as iden tified in accordance with paragraph (a) of this section, and that thus must be controlled for each fish and fishery product. Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of the following: (i) Natural toxins; (ii) Microbiological contamination; (iii) Chemical contamination; (iv) Pesticides; (v) Drug residues; (vi) Decomposition in scombroid toxin-forming species or in any other species where a food safety hazard has been associated with decomposition; (vii) Parasites, where the processor has knowledge or has reason to know that the parasite-containing fish or fishery product will be consumed with out a process sufficient to kill the parasites, or where the processor rep resents, labels, or intends for the prod uct to be so consumed; (viii) Unapproved use of direct or in direct food or color additives; and (ix) Physical hazards; (2) List the critical control points for each of the identified food safety haz ards, including as appropriate: (i) Critical control points designed to control food safety hazards that could be introduced in the processing plant environment; and (ii) Critical control points designed to control food safety hazards intro duced outside the processing plant en vironment, including food safety haz ards that occur before, during, and after harvest; (3) List the critical limits that must be met at each of the critical control points; (4) List the procedures, and frequency thereof, 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 § 123.7(b), to be followed VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00372 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 363 Food and Drug Administration, HHS § 123.7 in response to deviations from critical limits at critical control points; (6) List the verification procedures, and frequency thereof, that the proc essor will use in accordance with § 123.8(a); (7) Provide for a recordkeeping sys tem that documents the monitoring of the critical control points. The records shall contain the actual values and ob servations obtained during monitoring. (d) Signing and dating the HACCP plan. (1) The HACCP plan shall be signed and dated, either by the most responsible individual onsite at the processing facility or by a higher level official of the processor. This signature shall signify that the HACCP plan has been accepted for implementation by the firm. (2) The HACCP plan shall be dated and signed: (i) Upon initial acceptance; (ii) Upon any modification; and (iii) Upon verification of the plan in accordance with § 123.8(a)(1). (e) Products subject to other regula tions. For fish and fishery products that are subject to the requirements of part 113 or 114 of this chapter, the HACCP plan need not list the food safe ty hazard associated with the forma tion of Clostridium botulinum toxin in the finished, hermetically sealed con tainer, nor list the controls to prevent that food safety hazard. A HACCP plan for such fish and fishery products shall address any other food safety hazards that are reasonably likely to occur. (f) Sanitation. Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with § 123.11(b) they need not be included in the HACCP plan, and vice versa. (g) Legal basis. Failure of a processor to have and implement a HACCP plan that complies with this section when ever a HACCP plan is necessary, other wise operate in accordance with the re quirements of this part, shall render the fish or fishery products of that processor adulterated under section 402(a)(4) of the act. Whether a proc essor’s actions are consistent with en suring the safety of food will be deter mined through an evaluation of the processors overall implementation of its HACCP plan, if one is required. § 123.7 Corrective actions. (a) Whenever a deviation from a crit ical limit occurs, a processor shall take corrective action either by: (1) Following a corrective action plan that is appropriate for the particular deviation, or (2) Following the procedures in para graph (c) of this section. (b) Processors may develop written corrective action plans, which become part of their HACCP plans in accord ance with § 123.6(c)(5), by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A cor rective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and as signs 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. (c) 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 (c)(2) and (c)(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 a review. Adequate training may or may not include training in accord ance with § 123.10; (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; (5) Perform or obtain timely reassess ment by an individual or individuals who have been trained in accordance with § 123.10, to determine whether the VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00373 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 364 21 CFR Ch. I (4–1–15 Edition) § 123.8 HACCP plan needs to be modified to re duce the risk of recurrence of the devi ation, and modify the HACCP plan as necessary. (d) All corrective actions taken in ac cordance with this section shall be fully documented in records that are subject to verification in accordance with § 123.8(a)(3)(ii) and the record keeping requirements of § 123.9. § 123.8 Verification. (a) Overall verification. Every proc essor shall verify that the HACCP plan is adequate to control food safety haz ards that are reasonably likely to occur, and that the plan is being effec tively implemented. Verification shall include, at a minimum: (1) Reassessment of the HACCP plan. A reassessment of the adequacy of the HACCP plan whenever any changes occur that could affect the hazard anal ysis or alter the HACCP plan in any way or at least annually. Such changes may include changes in the following: Raw materials or source of raw mate rials, product formulation, processing methods or systems, finished product distribution systems, or the intended use or consumers of the finished prod uct. The reassessment shall be per formed by an individual or individuals who have been trained in accordance with § 123.10. The HACCP plan shall be modified immediately whenever a reas sessment reveals that the plan is no longer adequate to fully meet the re quirements of § 123.6(c). (2) Ongoing verification activities. On going verification activities including: (i) A review of any consumer com plaints that have been received by the processor to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points; (ii) The calibration of process-moni toring instruments; and, (iii) At the option of the processor, the performing of periodic end-product or in-process testing. (3) Records review. A review, including signing and dating, by an individual who has been trained in accordance with § 123.10, of the records that docu ment: (i) 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 they document values that are within the critical limits. This review shall occur within 1 week of the day that the records are made; (ii) 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 § 123.7. This review shall occur within 1 week of the day that the records are made; and (iii) The calibrating of any process control instruments used at critical control points and the performing of any periodic end-product or in-process testing that is part of the processor’s verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are com plete, 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. (b) Corrective actions. Processors shall immediately follow the procedures in § 123.7 whenever any verification proce dure, including the review of a con sumer complaint, reveals the need to take a corrective action. (c) Reassessment of the hazard analysis. Whenever a processor does not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are reasonably likely to occur, the processor shall reassess the adequacy of that hazard analysis whenever there are any changes that could reasonably affect whether a food safety hazard now exists. Such changes may include, but are not limited to changes in: Raw materials or source of raw materials, product formulation, processing meth ods or systems, finished product dis tribution systems, or the intended use or consumers of the finished product. The reassessment shall be performed by an individual or individuals who have been trained in accordance with § 123.10. (d) Recordkeeping. The calibration of process-monitoring instruments, and the performing of any periodic end product and in-process testing, in ac cordance with paragraphs (a)(2)(ii) through (iii) of this section shall be VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00374 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 365 Food and Drug Administration, HHS § 123.10 documented in records that are subject to the recordkeeping requirements of § 123.9. § 123.9 Records. (a) General requirements. All records required by this part shall include: (1) The name and location of the processor or importer; (2) The date and time of the activity that the record reflects; (3) The signature or initials of the person performing the operation; and (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. (b) Record retention. (1) All records re quired by this part shall be retained at the processing facility or importer’s place of business in the United States for at least 1 year after the date they were prepared in the case of refrig erated products and for at least 2 years after the date they were prepared in the case of frozen, preserved, or shelf stable products. (2) Records that relate to the general adequacy of equipment or processes being used by a processor, including the results of scientific studies and evaluations, shall be retained at the processing facility or the importer’s place of business in the United States for at least 2 years after their applica bility to the product being produced at the facility. (3) If the processing facility is closed for a prolonged period between sea sonal packs, or if record storage capac ity is limited on a processing vessel or at a remote processing site, the records may be transferred to some other rea sonably accessible location at the end of the seasonal pack but shall be imme diately returned for official review upon demand. (c) Official review. All records re quired by this part and all plans and procedures required by this part shall be available for official review and copying at reasonable times. (d) Public disclosure. (1) Subject to the limitations in paragraph (d)(2) of this section, all plans and records required by this part are not available for public disclosure unless they have been pre viously disclosed to the public as de fined in § 20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in § 20.61 of this chapter. (2) However, these records and plans may be subject to disclosure to the ex tent that they are otherwise publicly available, or that disclosure could not reasonably be expected to cause a com petitive hardship, such as generic-type HACCP plans that reflect standard in dustry practices. (e) Tags. Tags as defined in § 123.3(t) are not subject to the requirements of this section unless they are used to ful fill the requirements of § 123.28(c). (f) Records maintained on computers. The maintenance of records on com puters is acceptable, provided that ap propriate controls are implemented to ensure the integrity of the electronic data and signatures. § 123.10 Training. At a minimum, the following func tions shall be performed by an indi vidual who has successfully completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized cur riculum recognized as adequate by the U.S. Food and Drug Administration or who is otherwise qualified through job experience to perform these functions. Job experience will qualify an indi vidual to perform these functions if it has provided knowledge at least equiv alent to that provided through the standardized curriculum. (a) Developing a HACCP plan, which could include adapting a model or ge neric-type HACCP plan, that is appro priate for a specific processor, in order to meet the requirements of § 123.6(b); (b) Reassessing and modifying the HACCP plan in accordance with the corrective action procedures specified in § 123.7(c)(5), the HACCP plan in ac cordance with the verification activi ties specified in § 123.8(a)(1), and the hazard analysis in accordance with the verification activities specified in § 123.8(c); and VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00375 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 366 21 CFR Ch. I (4–1–15 Edition) § 123.11 (c) Performing the record review re quired by § 123.8(a)(3); The trained indi vidual need not be an employee of the processor. § 123.11 Sanitation control procedures. (a) Sanitation SOP. Each processor should have and implement a written sanitation standard operating proce dure (herein referred to as SSOP) or similar document that is specific to each location where fish and fishery products are produced. The SSOP should specify how the processor will meet those sanitation conditions and practices that are to be monitored in accordance with paragraph (b) of this section. (b) Sanitation monitoring. Each proc essor shall monitor the conditions and practices during processing with suffi cient frequency to ensure, at a min imum, conformance with those condi tions and practices specified in part 110 of this chapter that are both appro priate to the plant and the food being processed and relate to the following: (1) Safety of the water that comes into contact with food or food contact surfaces, or 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-contamina tion from insanitary objects to food, food packaging material, and other food contact surfaces, including uten sils, gloves, and outer garments, and from raw product to cooked 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. The processor shall correct in a time ly manner, those conditions and prac tices that are not met. (c) Sanitation control records. Each processor shall maintain sanitation control records that, at a minimum, document the monitoring and correc tions prescribed by paragraph (b) of this section. These records are subject to the requirements of § 123.9. (d) Relationship to HACCP plan. Sani tation controls may be included in the HACCP plan, required by § 123.6(b). However, to the extent that they are monitored in accordance with para graph (b) of this section they need not be included in the HACCP plan, and vice versa. § 123.12 Special requirements for im ported products. This section sets forth specific re quirements for imported fish and fish ery products. (a) Importer verification. Every im porter of fish or fishery products shall either: (1) Obtain the fish or fishery product from a country that has an active memorandum of understanding (MOU) or similar agreement with the Food and Drug Administration, that covers the fish or fishery product and docu ments the equivalency or compliance of the inspection system of the foreign country with the U.S. system, accu rately reflects the current situation be tween the signing parties, and is func tioning and enforceable in its entirety; or (2) Have and implement written verification procedures for ensuring that the fish and fishery products that they offer for import into the United States were processed in accordance with the requirements of this part. The procedures shall list at a minimum: (i) Product specifications that are de signed to ensure that the product is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act because it may be injurious to health or have been processed under insani tary conditions, and, (ii) Affirmative steps that may in clude any of the following: (A) Obtaining from the foreign proc essor the HACCP and sanitation moni toring records required by this part VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00376 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 367 Food and Drug Administration, HHS § 123.28 that relate to the specific lot of fish or fishery products being offered for im port; (B) Obtaining either a continuing or lot-by-lot certificate from an appro priate foreign government inspection authority or competent third party certifying that the imported fish or fishery product is or was processed in accordance with the requirements of this part; (C) Regularly inspecting the foreign processor’s facilities to ensure that the imported fish or fishery product is being processed in accordance with the requirements of this part; (D) Maintaining on file a copy, in English, of the foreign processor’s HACCP plan, and a written guarantee from the foreign processor that the im ported fish or fishery product is proc essed in accordance with the require ments of the part; (E) Periodically testing the imported fish or fishery product, and maintain ing on file a copy, in English, of a writ ten guarantee from the foreign proc essor that the imported fish or fishery product 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 § 123.9. (d) Determination of compliance. There must be evidence that all fish and fish ery products offered for entry into the United States have been processed under conditions that comply with this part. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of do mestic processors under this part, the product will appear to be adulterated and will be denied entry. Subpart B—Smoked and Smoke Flavored Fishery Products § 123.15 General. This subpart augments subpart A of this part by setting forth specific re quirements for processing smoked and smoke-flavored fishery products. § 123.16 Process controls. In order to meet the requirements of subpart A of this part, processors of smoked and smoke-flavored fishery products, except those subject to the requirements of part 113 or 114 of this chapter, shall include in their HACCP plans how they are controlling the food safety hazard associated with the for mation of toxin by Clostridium botu linum for at least as long as the shelf life of the product under normal and moderate abuse conditions. Subpart C—Raw Molluscan Shellfish § 123.20 General. This subpart augments subpart A of this part by setting forth specific re quirements for processing fresh or fro zen molluscan shellfish, where such processing does not include a treat ment that ensures the destruction of vegetative cells of microorganisms of public health concern. § 123.28 Source controls. (a) In order to meet the requirements of subpart A of this part as they apply to microbiological contamination, chemical contamination, natural tox ins, and related food safety hazards, processors shall include in their HACCP plans how they are controlling the origin of the molluscan shellfish they process to ensure that the condi tions of paragraphs (b), (c), and (d) of this section are met. (b) Processors shall only process molluscan shellfish harvested from growing waters approved for harvesting by a shellfish control authority. In the case of molluscan shellfish harvested from U.S. Federal waters, the require ments of this paragraph will be met so VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00377 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 368 21 CFR Ch. I (4–1–15 Edition) Pt. 129 long as the shellfish have not been har vested from waters that have been closed to harvesting by an agency of the Federal government. (c) To meet the requirements of para graph (b) of this section, processors who receive shellstock shall accept only shellstock from a harvester that is in compliance with such licensure requirements as may apply to the har vesting of molluscan shellfish or from a processor that is certified by a shell fish control authority, and that has a tag affixed to each container of shellstock. The tag shall bear, at a minimum, the information required in § 1240.60(b) of this chapter. In place of the tag, bulk shellstock shipments may be accompanied by a bill of lading or similar shipping document that con tains the information required in § 1240.60(b) of this chapter. Processors shall maintain records that document that all shellstock have met the re quirements of this section. These records shall document: (1) The date of harvest; (2) The location of harvest by State and site; (3) The quantity and type of shellfish; (4) The date of receipt by the proc essor; and (5) The name of the harvester, the name or registration number of the harvester’s vessel, or an identification number issued to the harvester by the shellfish control authority. (d) To meet the requirements of para graph (b) of this section, processors who receive shucked molluscan shell fish shall accept only containers of shucked molluscan shellfish that bear a label that complies with § 1240.60(c) of this chapter. Processors shall maintain records that document that all shucked molluscan shellfish have met the re quirements of this section. These records shall document: (1) The date of receipt; (2) The quantity and type of shellfish; and (3) The name and certification num ber of the packer or repacker of the product. PART 129—PROCESSING AND BOT TLING OF BOTTLED DRINKING WATER Subpart A—General Provisions Sec. 129.1 Current good manufacturing practice. 129.3 Definitions. Subpart B—Buildings and Facilities 129.20 Plant construction and design. 129.35 Sanitary facilities. 129.37 Sanitary operations. Subpart C—Equipment 129.40 Equipment and procedures. Subpart D [Reserved] Subpart E—Production and Process Controls 129.80 Processes and controls. AUTHORITY: 21 U.S.C. 342, 348, 371, 374; 42 U.S.C. 264. SOURCE: 42 FR 14355, Mar. 15, 1977, unless otherwise noted. Subpart A—General Provisions § 129.1 Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the criteria in §§ 129.20, 129.35, 129.37, 129.40, and 129.80 shall apply in determining whether the facilities, methods, practices, and con trols used in the processing, bottling, holding, and shipping of bottled drink ing water are in conformance with or are operated or administered in con formity with good manufacturing prac tice to assure that bottled drinking water is safe and that it has been proc essed, bottled, held, and transported under sanitary conditions. § 129.3 Definitions. For the purposes of this part, the fol lowing definitions apply: (a) Approved source when used in ref erence to a plant’s product water or op erations water means a source of water and the water therefrom, whether it be from a spring, artesian well, drilled well, municipal water supply, or any other source, that has been inspected and the water sampled, analyzed, and VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00378 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