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(v) MUG positive and negative con- PART 123— AND trols should be used as reference in in- PRODUCTS terpreting fluorescence reactions. Use an E. coli for positive control and 2 neg- Subpart A—General Provisions ative controls—a MUG negative strain and an uninoculated tube media. Sec. (d) If either 10 mL subsample is posi- 123.3 Definitions. 123.5 Current good manufacturing practice. tive for E. coli, the 20 mL sample is re- 123.6 Hazard analysis and Hazard Analysis corded as positive and the processor Critical Control Point (HACCP) plan. shall: 123.7 Corrective actions. (1) Review monitoring records for the 123.8 Verification. control measures to attain the 5-log re- 123.9 Records. duction standard and correct those 123.10 Training. conditions and practices that are not 123.11 Sanitation control procedures. met. In addition, the processor may 123.12 Special requirements for imported products. choose to test the sample for the pres- ence of pathogens of concern. Subpart B—Smoked and Smoke-Flavored (2) If the review of monitoring Fishery Products records or the additional testing indi- cates that the 5-log reduction standard 123.15 General. 123.16 Process controls. was not achieved (e.g., a sample is found to be positive for the presence of Subpart C—Raw Molluscan a pathogen or a deviation in the proc- ess or its delivery is identified), the 123.20 General. processor shall take corrective action 123.28 Source controls. as set forth in § 120.10. AUTHORITY: 21 U.S.C. 321, 342, 343, 346, 348, (e) If two samples in a series of seven 371, 374, 379e, 381, 393; 42 U.S.C. 241, 241l, 264. tests are positive for E. coli, the control SOURCE: 60 FR 65197, Dec. 18, 1995, unless measures to attain the 5-log reduction otherwise noted. standard shall be deemed to be inad- equate and the processor shall imme- Subpart A—General Provisions diately: (1) Until corrective actions are com- § 123.3 Definitions. pleted, use an alternative process or The definitions and interpretations processes that achieve the 5-log reduc- of terms in section 201 of the Federal tion after the juice has been expressed; , Drug, and Cosmetic Act (the act) (2) Perform a review of the moni- and in part 110 of this chapter are ap- toring records for control measures to plicable to such terms when used in attain the 5-log reduction standard. this part, except where they are herein The review shall be sufficiently exten- redefined. The following definitions sive to determine that there are no shall also apply: trends towards loss of control; (a) Certification number means a (i) If the conditions and practices are unique combination of letters and not being met, correct those that do numbers assigned by a shellfish control not conform to the HACCP plan; or authority to a molluscan shellfish (ii) If the conditions and practices processor. are being met, the processor shall vali- (b) Critical control point means a point, step, or procedure in a food proc- date the HACCP plan in relation to the ess at which control can be applied, 5-log reduction standard; and and a food safety hazard can as a result (3) Take corrective action as set be prevented, eliminated, or reduced to forth in § 120.10. Corrective actions acceptable levels. shall include ensuring no product en- (c) Critical limit means the maximum ters commerce that is injurious to or minimum value to which a physical, health as set forth in § 120.10(a)(1). biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an

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acceptable level the occurrence of the (ii) Practices such as heading, evis- identified food safety hazard. cerating, or freezing intended solely to (d) Fish means fresh or saltwater prepare a fish for holding on board a finfish, , other forms of harvest vessel. (including, but not (iii) The operation of a retail estab- limited to, alligator, frog, aquatic tur- lishment. tle, , cucumber, and sea ur- (l) Processor means any person en- chin and the of such animals) other gaged in commercial, custom, or insti- than birds or mammals, and all mol- tutional processing of fish or fishery lusks, where such animal life is in- products, either in the United States or tended for human consumption. in a foreign country. A processing in- (e) Fishery product means any human cludes any person engaged in the pro- food product in which fish is a charac- duction of that are to be used in terizing ingredient. market or consumer tests. (f) Food safety hazard means any bio- (m) Scombroid toxin-forming species logical, chemical, or physical property means , bluefish, mahi mahi, and that may cause a food to be unsafe for other species, whether or not in the human consumption. family , in which signifi- cant levels of histamine may be pro- (g) Importer means either the U.S. duced in the fish flesh by owner or consignee at the time of entry decarboxylation of free histidine as a into the United States, or the U.S. result of exposure of the fish after cap- agent or representative of the foreign ture to temperatures that permit the owner or consignee at the time of entry growth of mesophilic bacteria. into the United States, who is respon- (n) Shall is used to state mandatory sible for ensuring that goods being of- requirements. fered for entry into the United States (o) Shellfish control authority means a are in compliance with all laws affect- Federal, State, or foreign agency, or ing the importation. For the purposes sovereign tribal government, legally of this definition, ordinarily the im- responsible for the administration of a porter is not the custom house broker, program that includes activities such the freight forwarder, the carrier, or as classification of molluscan shellfish the steamship representative. growing areas, enforcement of (h) means any edi- Molluscan shellfish molluscan shellfish harvesting con- ble species of fresh or frozen , trols, and certification of molluscan clams, , or , or edible shellfish processors. portions of such species, except when (p) Shellstock means raw, in-shell the product consists entirely of the molluscan shellfish. shucked adductor muscle. (q) Should is used to state rec- (i) Preventive measure means physical, ommended or advisory procedures or to chemical, or other factors that can be identify recommended equipment. used to control an identified food safe- (r) Shucked shellfish means molluscan ty hazard. shellfish that have one or both shells (j) Process-monitoring instrument removed. means an instrument or device used to (s) Smoked or smoke-flavored fishery indicate conditions during processing products means the finished food pre- at a critical control point. pared by: (k)(1) Processing means, with respect (1) Treating fish with salt (sodium to fish or fishery products: Handling, chloride), and storing, preparing, heading, evis- (2) Subjecting it to the direct action cerating, shucking, freezing, changing of smoke from burning , sawdust, into different market forms, manufac- or similar material and/or imparting to turing, preserving, packing, labeling, it the flavor of smoke by a means such dockside unloading, or holding. as immersing it in a solution of wood (2) The regulations in this part do smoke. not apply to: (t) Tag means a record of harvesting (i) Harvesting or transporting fish or information attached to a container of fishery products, without otherwise en- shellstock by the harvester or proc- gaging in processing. essor.

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§ 123.5 Current good manufacturing in paragraph (c) of this section are practice. identical for all fish and fishery prod- (a) Part 110 of this chapter applies in ucts so grouped or for all production determining whether the facilities, methods so grouped. methods, practices, and controls used (c) The contents of the HACCP plan. to process fish and fishery products are The HACCP plan shall, at a minimum: safe, and whether these products have (1) List the food safety hazards that been processed under sanitary condi- are reasonably likely to occur, as iden- tions. tified in accordance with paragraph (a) (b) The purpose of this part is to set of this section, and that thus must be forth requirements specific to the proc- controlled for each fish and fishery essing of fish and fishery products. product. Consideration should be given to whether any food safety hazards are § 123.6 Hazard analysis and Hazard reasonably likely to occur as a result Analysis Critical Control Point of the following: (HACCP) plan. (i) Natural toxins; (a) Hazard analysis. Every processor (ii) Microbiological contamination; shall conduct, or have conducted for it, (iii) Chemical contamination; a hazard analysis to determine whether (iv) Pesticides; there are food safety hazards that are (v) Drug residues; reasonably likely to occur for each (vi) Decomposition in scombroid kind of fish and fishery product proc- toxin-forming species or in any other essed by that processor and to identify species where a food safety hazard has the preventive measures that the proc- been associated with decomposition; essor can apply to control those haz- (vii) Parasites, where the processor ards. Such food safety hazards can be has knowledge or has reason to know introduced both within and outside the that the parasite-containing fish or processing plant environment, includ- fishery product will be consumed with- ing food safety hazards that can occur out a process sufficient to kill the before, during, and after harvest. A parasites, or where the processor rep- food safety hazard that is reasonably resents, labels, or intends for the prod- likely to occur is one for which a pru- uct to be so consumed; dent processor would establish controls (viii) Unapproved use of direct or in- because experience, illness data, sci- direct food or color additives; and entific reports, or other information (ix) Physical hazards; provide a basis to conclude that there (2) List the critical control points for is a reasonable possibility that it will each of the identified food safety haz- occur in the particular type of fish or ards, including as appropriate: fishery product being processed in the (i) Critical control points designed to absence of those controls. control food safety hazards that could (b) The HACCP plan. Every processor be introduced in the processing plant shall have and implement a written environment; and HACCP plan whenever a hazard anal- (ii) Critical control points designed ysis reveals one or more food safety to control food safety hazards intro- hazards that are reasonably likely to duced outside the processing plant en- occur, as described in paragraph (a) of vironment, including food safety haz- this section. A HACCP plan shall be ards that occur before, during, and specific to: after harvest; (1) Each location where fish and fish- (3) List the critical limits that must ery products are processed by that be met at each of the critical control processor; and points; (2) Each kind of fish and fishery prod- (4) List the procedures, and frequency uct processed by the processor. The thereof, that will be used to monitor plan may group kinds of fish and fish- each of the critical control points to ery products together, or group kinds ensure compliance with the critical of production methods together, if the limits; food safety hazards, critical control (5) Include any corrective action points, critical limits, and procedures plans that have been developed in ac- required to be identified and performed cordance with § 123.7(b), to be followed

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in response to deviations from critical § 123.7 Corrective actions. limits at critical control points; (a) Whenever a deviation from a crit- (6) List the verification procedures, ical limit occurs, a processor shall take and frequency thereof, that the proc- corrective action either by: essor will use in accordance with § 123.8(a); (1) Following a corrective action plan (7) Provide for a recordkeeping sys- that is appropriate for the particular tem that documents the monitoring of deviation, or the critical control points. The records (2) Following the procedures in para- shall contain the actual values and ob- graph (c) of this section. servations obtained during monitoring. (b) Processors may develop written (d) Signing and dating the HACCP corrective action plans, which become plan. (1) The HACCP plan shall be part of their HACCP plans in accord- signed and dated, either by the most ance with § 123.6(c)(5), by which they responsible individual onsite at the predetermine the corrective actions processing facility or by a higher level that they will take whenever there is a official of the processor. This signature deviation from a critical limit. A cor- shall signify that the HACCP plan has rective action plan that is appropriate been accepted for implementation by for a particular deviation is one that the firm. describes the steps to be taken and as- (2) The HACCP plan shall be dated signs responsibility for taking those and signed: steps, to ensure that: (i) Upon initial acceptance; (1) No product enters commerce that (ii) Upon any modification; and is either injurious to health or is other- (iii) Upon verification of the plan in wise adulterated as a result of the devi- accordance with § 123.8(a)(1). ation; and (e) Products subject to other regula- (2) The cause of the deviation is cor- tions. For fish and fishery products rected. that are subject to the requirements of (c) When a deviation from a critical part 113 or 114 of this chapter, the limit occurs and the processor does not HACCP plan need not list the food safe- have a corrective action plan that is ty hazard associated with the forma- appropriate for that deviation, the tion of Clostridium botulinum toxin in processor shall: the finished, hermetically sealed con- (1) Segregate and hold the affected tainer, nor list the controls to prevent product, at least until the require- that food safety hazard. A HACCP plan ments of paragraphs (c)(2) and (c)(3) of for such fish and fishery products shall this section are met; address any other food safety hazards (2) Perform or obtain a review to de- that are reasonably likely to occur. termine the acceptability of the af- (f) Sanitation. Sanitation controls fected product for distribution. The re- may be included in the HACCP plan. view shall be performed by an indi- However, to the extent that they are vidual or individuals who have ade- monitored in accordance with § 123.11(b) quate training or experience to perform they need not be included in the such a review. Adequate training may HACCP plan, and vice versa. or may not include training in accord- (g) Legal basis. Failure of a processor ance with § 123.10; to have and implement a HACCP plan (3) Take corrective action, when nec- that complies with this section when- essary, with respect to the affected ever a HACCP plan is necessary, other- product to ensure that no product en- wise operate in accordance with the re- ters commerce that is either injurious quirements of this part, shall render to health or is otherwise adulterated as the fish or fishery products of that a result of the deviation; processor adulterated under section (4) Take corrective action, when nec- 402(a)(4) of the act. Whether a proc- essary, to correct the cause of the devi- essor’s actions are consistent with en- ation; suring the safety of food will be deter- (5) Perform or obtain timely reassess- mined through an evaluation of the ment by an individual or individuals processors overall implementation of who have been trained in accordance its HACCP plan, if one is required. with § 123.10, to determine whether the

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HACCP plan needs to be modified to re- be, at a minimum, to ensure that the duce the risk of recurrence of the devi- records are complete and to verify that ation, and modify the HACCP plan as they document values that are within necessary. the critical limits. This review shall (d) All corrective actions taken in ac- occur within 1 week of the day that the cordance with this section shall be records are made; fully documented in records that are (ii) The taking of corrective actions. subject to verification in accordance The purpose of this review shall be, at with § 123.8(a)(3)(ii) and the record- a minimum, to ensure that the records keeping requirements of § 123.9. are complete and to verify that appro- priate corrective actions were taken in § 123.8 Verification. accordance with § 123.7. This review (a) Overall verification. Every proc- shall occur within 1 week of the day essor shall verify that the HACCP plan that the records are made; and is adequate to control food safety haz- (iii) The calibrating of any process ards that are reasonably likely to control instruments used at critical occur, and that the plan is being effec- control points and the performing of tively implemented. Verification shall any periodic end-product or in-process include, at a minimum: testing that is part of the processor’s (1) Reassessment of the HACCP plan. A verification activities. The purpose of reassessment of the adequacy of the these reviews shall be, at a minimum, HACCP plan whenever any changes to ensure that the records are com- occur that could affect the hazard anal- plete, and that these activities oc- ysis or alter the HACCP plan in any curred in accordance with the proc- way or at least annually. Such changes essor’s written procedures. These re- may include changes in the following: views shall occur within a reasonable Raw materials or source of raw mate- time after the records are made. rials, product formulation, processing (b) Corrective actions. Processors shall methods or systems, finished product immediately follow the procedures in distribution systems, or the intended § 123.7 whenever any verification proce- use or consumers of the finished prod- dure, including the review of a con- uct. The reassessment shall be per- sumer complaint, reveals the need to formed by an individual or individuals take a corrective action. who have been trained in accordance (c) Reassessment of the hazard analysis. with § 123.10. The HACCP plan shall be Whenever a processor does not have a modified immediately whenever a reas- HACCP plan because a hazard analysis sessment reveals that the plan is no has revealed no food safety hazards longer adequate to fully meet the re- that are reasonably likely to occur, the quirements of § 123.6(c). processor shall reassess the adequacy (2) Ongoing verification activities. On- of that hazard analysis whenever there going verification activities including: are any changes that could reasonably (i) A review of any consumer com- affect whether a food safety hazard plaints that have been received by the now exists. Such changes may include, processor to determine whether they but are not limited to changes in: Raw relate to the performance of critical materials or source of raw materials, control points or reveal the existence product formulation, processing meth- of unidentified critical control points; ods or systems, finished product dis- (ii) The calibration of process-moni- tribution systems, or the intended use toring instruments; and, or consumers of the finished product. (iii) At the option of the processor, The reassessment shall be performed the performing of periodic end-product by an individual or individuals who or in-process testing. have been trained in accordance with (3) Records review. A review, including § 123.10. signing and dating, by an individual (d) Recordkeeping. The calibration of who has been trained in accordance process-monitoring instruments, and with § 123.10, of the records that docu- the performing of any periodic end- ment: product and in-process testing, in ac- (i) The monitoring of critical control cordance with paragraphs (a)(2)(ii) points. The purpose of this review shall through (iii) of this section shall be

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documented in records that are subject fined in § 20.81 of this chapter or they to the recordkeeping requirements of relate to a product or ingredient that § 123.9. has been abandoned and they no longer represent a trade secret or confidential § 123.9 Records. commercial or financial information as (a) General requirements. All records defined in § 20.61 of this chapter. required by this part shall include: (2) However, these records and plans (1) The name and location of the may be subject to disclosure to the ex- processor or importer; tent that they are otherwise publicly (2) The date and time of the activity available, or that disclosure could not that the record reflects; reasonably be expected to cause a com- (3) The signature or initials of the petitive hardship, such as generic-type person performing the operation; and HACCP plans that reflect standard in- (4) Where appropriate, the identity of the product and the production code, if dustry practices. any. Processing and other information (e) Tags. Tags as defined in § 123.3(t) shall be entered on records at the time are not subject to the requirements of that it is observed. this section unless they are used to ful- (b) Record retention. (1) All records re- fill the requirements of § 123.28(c). quired by this part shall be retained at (f) Records maintained on computers. the processing facility or importer’s The maintenance of records on com- place of business in the United States puters is acceptable, provided that ap- for at least 1 year after the date they propriate controls are implemented to were prepared in the case of refrig- ensure the integrity of the electronic erated products and for at least 2 years data and signatures. after the date they were prepared in the case of frozen, preserved, or shelf- § 123.10 Training. stable products. At a minimum, the following func- (2) Records that relate to the general tions shall be performed by an indi- adequacy of equipment or processes vidual who has successfully completed being used by a processor, including training in the application of HACCP the results of scientific studies and evaluations, shall be retained at the principles to fish and fishery product processing facility or the importer’s processing at least equivalent to that place of business in the United States received under standardized cur- for at least 2 years after their applica- riculum recognized as adequate by the bility to the product being produced at U.S. Food and Drug Administration or the facility. who is otherwise qualified through job (3) If the processing facility is closed experience to perform these functions. for a prolonged period between sea- Job experience will qualify an indi- sonal packs, or if record storage capac- vidual to perform these functions if it ity is limited on a processing vessel or has provided knowledge at least equiv- at a remote processing site, the records alent to that provided through the may be transferred to some other rea- standardized curriculum. sonably accessible location at the end (a) Developing a HACCP plan, which of the seasonal pack but shall be imme- could include adapting a model or ge- diately returned for official review neric-type HACCP plan, that is appro- upon demand. priate for a specific processor, in order (c) Official review. All records re- to meet the requirements of § 123.6(b); quired by this part and all plans and (b) Reassessing and modifying the procedures required by this part shall HACCP plan in accordance with the be available for official review and corrective action procedures specified copying at reasonable times. (d) Public disclosure. (1) Subject to the in § 123.7(c)(5), the HACCP plan in ac- limitations in paragraph (d)(2) of this cordance with the verification activi- section, all plans and records required ties specified in § 123.8(a)(1), and the by this part are not available for public hazard analysis in accordance with the disclosure unless they have been pre- verification activities specified in viously disclosed to the public as de- § 123.8(c); and

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(c) Performing the record review re- The processor shall correct in a time- quired by § 123.8(a)(3); The trained indi- ly manner, those conditions and prac- vidual need not be an employee of the tices that are not met. processor. (c) Sanitation control records. Each processor shall maintain sanitation § 123.11 Sanitation control procedures. control records that, at a minimum, (a) Sanitation SOP. Each processor document the monitoring and correc- should have and implement a written tions prescribed by paragraph (b) of sanitation standard operating proce- this section. These records are subject dure (herein referred to as SSOP) or to the requirements of § 123.9. similar document that is specific to (d) Relationship to HACCP plan. Sani- each location where fish and fishery tation controls may be included in the products are produced. The SSOP HACCP plan, required by § 123.6(b). should specify how the processor will However, to the extent that they are meet those sanitation conditions and monitored in accordance with para- practices that are to be monitored in graph (b) of this section they need not accordance with paragraph (b) of this be included in the HACCP plan, and section. vice versa. (b) Sanitation monitoring. Each proc- § 123.12 Special requirements for im- essor shall monitor the conditions and ported products. practices during processing with suffi- cient frequency to ensure, at a min- This section sets forth specific re- imum, conformance with those condi- quirements for imported fish and fish- tions and practices specified in part 110 ery products. of this chapter that are both appro- (a) Importer verification. Every im- priate to the plant and the food being porter of fish or fishery products shall processed and relate to the following: either: (1) Obtain the fish or fishery product (1) Safety of the that comes from a country that has an active into contact with food or food contact memorandum of understanding (MOU) surfaces, or is used in the manufacture or similar agreement with the Food of ; and Drug Administration, that covers (2) Condition and cleanliness of food the fish or fishery product and docu- contact surfaces, including utensils, ments the equivalency or compliance gloves, and outer garments; of the inspection system of the foreign (3) Prevention of cross-contamina- country with the U.S. system, accu- tion from insanitary objects to food, rately reflects the current situation be- food packaging material, and other tween the signing parties, and is func- food contact surfaces, including uten- tioning and enforceable in its entirety; sils, gloves, and outer garments, and or from raw product to cooked product; (2) Have and implement written (4) Maintenance of hand washing, verification procedures for ensuring hand sanitizing, and toilet facilities; that the fish and fishery products that (5) Protection of food, food packaging they offer for import into the United material, and food contact surfaces States were processed in accordance from adulteration with lubricants, fuel, with the requirements of this part. The pesticides, cleaning compounds, sani- procedures shall list at a minimum: tizing agents, condensate, and other (i) Product specifications that are de- chemical, physical, and biological con- signed to ensure that the product is not taminants; adulterated under section 402 of the (6) Proper labeling, storage, and use Federal Food, Drug, and Cosmetic Act of toxic compounds; because it may be injurious to health (7) Control of employee health condi- or have been processed under insani- tions that could result in the micro- tary conditions, and, biological contamination of food, food (ii) Affirmative steps that may in- packaging materials, and food contact clude any of the following: surfaces; and (A) Obtaining from the foreign proc- (8) Exclusion of pests from the food essor the HACCP and sanitation moni- plant. toring records required by this part

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that relate to the specific lot of fish or product will appear to be adulterated fishery products being offered for im- and will be denied entry. port; (B) Obtaining either a continuing or Subpart B—Smoked and Smoke- lot-by-lot certificate from an appro- Flavored Fishery Products priate foreign government inspection authority or competent third party § 123.15 General. certifying that the imported fish or This subpart augments subpart A of fishery product is or was processed in this part by setting forth specific re- accordance with the requirements of quirements for processing smoked and this part; smoke-flavored fishery products. (C) Regularly inspecting the foreign processor’s facilities to ensure that the § 123.16 Process controls. imported fish or fishery product is In order to meet the requirements of being processed in accordance with the subpart A of this part, processors of requirements of this part; smoked and smoke-flavored fishery (D) Maintaining on file a copy, in products, except those subject to the English, of the foreign processor’s requirements of part 113 or 114 of this HACCP plan, and a written guarantee chapter, shall include in their HACCP from the foreign processor that the im- plans how they are controlling the food ported fish or fishery product is proc- safety hazard associated with the for- essed in accordance with the require- mation of toxin by Clostridium botu- ments of the part; linum for at least as long as the shelf (E) Periodically testing the imported life of the product under normal and fish or fishery product, and maintain- moderate abuse conditions. ing on file a copy, in English, of a writ- ten guarantee from the foreign proc- Subpart C—Raw Molluscan essor that the imported fish or fishery Shellfish product is processed in accordance with the requirements of this part or, § 123.20 General. (F) Other such verification measures This subpart augments subpart A of as appropriate that provide an equiva- this part by setting forth specific re- lent level of assurance of compliance quirements for processing fresh or fro- with the requirements of this part. zen molluscan shellfish, where such (b) Competent third party. An importer processing does not include a treat- may hire a competent third party to ment that ensures the destruction of assist with or perform any or all of the vegetative cells of microorganisms of verification activities specified in para- public health concern. graph (a)(2) of this section, including writing the importer’s verification pro- § 123.28 Source controls. cedures on the importer’s behalf. (a) In order to meet the requirements (c) Records. The importer shall main- of subpart A of this part as they apply tain records, in English, that document to microbiological contamination, the performance and results of the af- chemical contamination, natural tox- firmative steps specified in paragraph ins, and related food safety hazards, (a)(2)(ii) of this section. These records processors shall include in their shall be subject to the applicable provi- HACCP plans how they are controlling sions of § 123.9. the origin of the molluscan shellfish (d) Determination of compliance. There they process to ensure that the condi- must be evidence that all fish and fish- tions of paragraphs (b), (c), and (d) of ery products offered for entry into the this section are met. United States have been processed (b) Processors shall only process under conditions that comply with this molluscan shellfish harvested from part. If assurances do not exist that the growing approved for harvesting imported fish or fishery product has by a shellfish control authority. In the been processed under conditions that case of molluscan shellfish harvested are equivalent to those required of do- from U.S. Federal waters, the require- mestic processors under this part, the ments of this paragraph will be met so

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long as the shellfish have not been har- PART 129—PROCESSING AND BOT- vested from waters that have been TLING OF BOTTLED DRINKING closed to harvesting by an agency of WATER the Federal government. (c) To meet the requirements of para- Subpart A—General Provisions graph (b) of this section, processors who receive shellstock shall accept Sec. 129.1 Current good manufacturing practice. only shellstock from a harvester that 129.3 Definitions. is in compliance with such licensure requirements as may apply to the har- Subpart B—Buildings and Facilities vesting of molluscan shellfish or from 129.20 Plant construction and design. a processor that is certified by a shell- 129.35 Sanitary facilities. fish control authority, and that has a 129.37 Sanitary operations. tag affixed to each container of shellstock. The tag shall bear, at a Subpart C—Equipment minimum, the information required in 129.40 Equipment and procedures. § 1240.60(b) of this chapter. In place of the tag, bulk shellstock shipments may Subpart D [Reserved] be accompanied by a bill of lading or similar shipping document that con- Subpart E—Production and Process tains the information required in Controls § 1240.60(b) of this chapter. Processors 129.80 Processes and controls. shall maintain records that document AUTHORITY: 21 U.S.C. 342, 348, 371, 374; 42 that all shellstock have met the re- U.S.C. 264. quirements of this section. These records shall document: SOURCE: 42 FR 14355, Mar. 15, 1977, unless otherwise noted. (1) The date of harvest; (2) The location of harvest by State and site; Subpart A—General Provisions (3) The quantity and type of shellfish; § 129.1 Current good manufacturing (4) The date of receipt by the proc- practice. essor; and The applicable criteria in part 110 of (5) The name of the harvester, the this chapter, as well as the criteria in name or registration number of the §§ 129.20, 129.35, 129.37, 129.40, and 129.80 harvester’s vessel, or an identification shall apply in determining whether the number issued to the harvester by the facilities, methods, practices, and con- shellfish control authority. trols used in the processing, bottling, (d) To meet the requirements of para- holding, and shipping of bottled drink- graph (b) of this section, processors ing water are in conformance with or who receive shucked molluscan shell- are operated or administered in con- fish shall accept only containers of formity with good manufacturing prac- shucked molluscan shellfish that bear tice to assure that bottled drinking a label that complies with § 1240.60(c) of water is safe and that it has been proc- this chapter. Processors shall maintain essed, bottled, held, and transported records that document that all shucked under sanitary conditions. molluscan shellfish have met the re- § 129.3 Definitions. quirements of this section. These records shall document: For the purposes of this part, the fol- lowing definitions apply: (1) The date of receipt; (a) Approved source when used in ref- (2) The quantity and type of shellfish; erence to a plant’s product water or op- and erations water means a source of water (3) The name and certification num- and the water therefrom, whether it be ber of the packer or repacker of the from a spring, artesian well, drilled product. well, municipal water supply, or any other source, that has been inspected and the water sampled, analyzed, and

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