美国HACCP要求英文

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1、Title 21: Food and DrugsPART 120 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMSSect ion ContentsSubpart A Gen eral Provisi ons20.1Applicability.20.3Definitions.20.5Current good manufacturing practice.20.6Sanitation standard operating procedures.20.7Hazard analysis.20.8Hazard Analysis and

2、 Critical Control Point (HACCP) plan.20.9Legal basis.20.10Corrective actions.勺20.11Verification and validation.20.12Records.20.13Training.20.14Application of requirements to imported products.Subpart B Pathoge n Reducti on20.20General.20.24Process cont s.20.25Process verification for certain process

3、ors.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, uni ess otherwise noted.Subpart A Gen eral Provisi ons120.1Applicability.(a) Any juice sold as such or used as an in gredie nt in beverages shall be processed in acc

4、orda nee with the requirements of this part. Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree. The requireme nts of this part shall apply to any

5、juice regardless of whether the juice, or any of itsin gredie nts, is or has bee n shipped in in terstate commerce (as defi ned in sect ion 201(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321(b). Raw agricultural ingredients of juice are not subject to the requireme nts of this part. P

6、rocessors should apply exist ing age ncy guida nee to mini mize 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 notbin di ng on small and very

7、 small bus in esses un til the dates listed in paragraphs (b)(1) and (b)(2) of this sect ion.(1) For small bus in esses emplo ying fewer tha n 500 pers ons the regulati ons in this part are binding on January : 2003.(2) For very small bus in esses that have either total annual sales of less tha n $5

8、00,000, or if their total annual sales are greater tha n $500,000 but their total food sales are less tha n $50,000; or the pers on clai ming this exemptio n employed fewer tha n an average of 100 full-time equivale nt employees and fewer tha n 100,000 un its of juice were sold in the Un ited States

9、, the regulati ons are bin di ng on January 20, 2004.120.3Defi nitio ns.The defi niti ons of terms in sect ion 201 of the Federal Food, Drug, and Cosmetic Act, 101.9110 of this chapter are applicable to such terms whe n used in this part, except where redefi ned in this part. The following definitio

10、ns shall also apply:(a) Cleanedmeans washed with water of adequate sanitary quality.(b) Control means to prevent, eliminate, or reduce.(c) Control measuremeans any action or activity to prevent, reduce to acceptable levels, or eliminate a hazard.(d) Critical control pointmeans a point, step, or proc

11、edure in a food process at which a control measure can be applied and at which control is essential to reduce an identified food hazard to an acceptable level.(e) Critical limit means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical

12、 control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.(f) Culled means separation of damaged fruit from undamaged fruit. For processors of citrus juices using treatments to fruit surfaces to comply withculledm1e2a0n.s24u,ndamaged, tree-pi

13、cked fruit that is U.S.Department of Agriculture choice or higher quality.(g) Food hazardmeans any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.(h) Importermeans either the U.S. owner or consignee at the time of entry of a

14、 food product into the United States, or the U.S. agent or representative of the foreign owner or consignee at the time of entry into the United States. The importer is responsible for ensuring that goods being offered for entry into the United States are in compliance with all applicable laws. For

15、the purposes of this definition, the importer is ordinarily not the custom house broker, the freight forwarder, the carrier, or the steamship representative.(i) Monitor means to conduct a planned sequence of observations or measurements to assess whether a proces point, or procedure is under control

16、 and to produce an accurate record for use in verification.(j) (1) Processingmeans activities that are directly related to the production of juice products.(2) For purposes of this part, processing does not include:(i) Harvesting, picking, or transporting raw agricultural ingredients of juice produc

17、ts, without otherwise engaging in processing; and(ii) The operation of a retail establishment.(k) Processormeans any person engaged in commercial, custom, or institutional processing of juice products, either in the United States or in a foreign country, including any person engaged in the processin

18、g of juice products that are intended for use in market or consumer tests.(l) Retail establishmenits an operation that provides juice directly to the consumers and does not include an establishment that sells or distributes juice to other business entities as well as directly to consumers. “Provides

19、 ” includes storing, preparing, packaging, serving, and vending.(m) Shallis used to state mandatory requirements.(n) Shelf-stable producmt eans a product that is hermetically sealed and, when stored at room temperature, should not demonstrate any microbial growth.(o) Shouldis used to state recommend

20、ed or advisory procedures or to identify recommended equipment.(p) Validation means that element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the identified food haza

21、rds.(q) Verification means those activities, other than monitoring, that establish the validity of the HACCP plan and that the system is operating according to the plan.120.5Current good manufacturing practice.Part 110 of this chapter applies in determining whether the facilities, methods, practices

22、, and controls used to process juice are safe, and whether the food has been processed under sanitary conditions.120.6Sanitation standard operating procedures.(a) Sanitation controlsE. ach processor shall have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation c

23、onditions and practices before, during, and after processing. The SSOP sha address:(1) Safety of the water that comes into contact with food or food contact surfaces or that is used in the manufacture of ice;(2) Condition and cleanliness of food contact surfaces, including utensils, gloves, and oute

24、r garments;(3) Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product;(4) Maintenance of hand washing, hand sanitizing, and toilet facilitie

25、s;(5) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;(6) Proper labeling, storage, and use of toxic compounds;(7)

26、Control of employee health conditions that could result in the microbiological 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 suf

27、ficient frequency to ensure, at a minimum, conformance with those conditions and practices specified in part 110 of thi chapter that are appropriate both to the plant and to the food being processed. Each processor shall correct, in timely manner, those conditions and practices that are not met.(c)

28、Records.Each processor shall maintain SSOP records that, at a minimum, document the monitoring and corrections prescribed by paragraph (b) of this section. These records are subject to the recordkeeping requirements of 120.12.(d) Relationship to Hazard Analysis and Critical Control Point (HACCP) plS

29、aann. itation standard operating procedure controls may be inclued in the HACCP plan required under120.8(b). However, to the extent ththey are implemented in accordance with this section, they need not be included in the HACCP plan. 120.7Hazard analysis.(a) Each processor shall develop, or have deve

30、loped 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 sha consist o

31、f 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 f

32、or which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that, in the absenc of those controls, the food hazard will occur in the particular type of product bein

33、g processed. This evaluation shall include an assessment of the severity of the illness or injury if the food hazard occurs;(3) Identification of the control measures that the processor can apply to control the food hazards identified as reasonably likely to occur in paragraph (a)(2) of this section

34、;(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 processin plant environment, including food hazards that can occ

35、ur before, during, and after harvest. The hazard analysisshall be developed by an individual or individuals who have been trained in accordance with120be subject to the recordkeeping requirements of120.12.(c) In evaluating what food hazards are reasonably likely to occur, consideration should be giv

36、en, 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) Pres

37、ence of undeclared ingredients that may be allergens; and(9) Physical hazards.(d) Processors should evaluate product ingredients, processing procedures, packaging, storage, and intended u facility and equipment function and design; and plant sanitation, including employee hygiene, to determine the p

38、otential effect of each on the safety of the finished food for the intended consumer.(e) HACCP plans for juice need not address the food hazards associated with microorganisms and microbial toxins that are controlled by the requirements of part 113 or part 114 of this chapter. A HACCP plan for such

39、juice shall address any other food hazards that are reasonably likely to occur.120.8Hazard Analysis and Critical Control Point (HACCP) plan.(a) HACCP plan.Each processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food hazards that are reasonably like

40、ly to occur during processing, as described in The HACCP plan shall be developed by an individual or individuals who have been trained in accordance with 120.13 and shall be subject to the recordkeeping requirements of120.12. A HACCP plan shal(1) Each location where juice is processed by that proces

41、sor; and(2) Each type of juice processed by the processor. The plan may group types of juice products together, or grou types of production methods together, if the food hazards, critical control points, critical limits, and procedures required to be identified and performed by paragraph (b) of this

42、 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 pla and are observed in practice.(b) The contents of the HACCP planT.he HACCP plan shall, at a minimum:(1) List all food hazards that are

43、reasonably likely to occur as identified in accordance with 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 hazar

44、ds that are reasonably likely to occur and could be introduced inside the processing plant environment; and(ii) Critical control points designed to control food hazards introduced outside the processing plant environment, including food hazards that occur before, during, and after harvest;(3) List t

45、he critical limits that shall be met at each of the critical control points;(4) List the procedures, and the frequency with which they are to be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;(5) Include any corrective action

46、 plans thaatvhe been developed in accordance with120.10(a), and that arbe followed in response to deviations from critical limits at critical control points;(6) List the validation and verification procedures, and the frequency with which they are to be performed, that the processor will use in acco

47、rdance with120.11; and(7) Provide for a recordkeeping system that documents the monitoring of the critical control points inaccordance with120.12. The records shall contain the actual values and obosbetravianteiodndsuring monitoring.(c) Sanitation.Sanitation controls may be included in the HACCP pla

48、n. However, to the extent that they are monitored in accordance with120.6, they are not required to be included in the HACCP plan.120.9L egal basis.Failure of a processor to have and to implement a Hazard Analysis and Critical Control Point (HACCP) system that complies with 120.6, 120.7, and 120.8,

49、or otherwise to operate in accordance with the requiremenpart, shall render the juice products of that processor adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Whether a processors actions are consistent with ensuring the safety of juice will be determined through a

50、n evaluation of the processors overall implementation of its HACCP system.120.10Corrective actions.Whenever a deviation from a critical limit occurs, a processor shall take corrective action by following the procedures set forth in paragraph (a) or paragraph (b) of this section.(a) Processors may de

51、velop written corrective action plans, which become part of their HACCP plans in accordance with 120.8(b)(5), by which processors predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular

52、 deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:(1) No product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and(2) The cause of the deviation is corrected.(b) When

53、 a deviation from a critical limit occurs, and the processor does not have a corrective action plan that is appropriate for that deviation, the processor shall:(1) Segregate and hold the affected product, at least until the requirements of paragraphs (b)(2) and (b)(3) of thi section are met;(2) Perf

54、orm or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform such review;(3) Take corrective action, when necessary, with respect to the affected produ

55、ct to ensure that no product enter commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;(4) Take corrective action, when necessary, to correct the cause of the deviation; and(5) Perform or obtain timely verification in accordance with120.1r 1in, dbiyvi

56、daunainlsdwivhidouhalaovebeen trained in accordance with 120.13, to determine whether modification of the HACCP plan is requirreduce the risk of recurrence of the deviation, and to modify the HACCP plan as necessary.(c) All corrective actions taken in accordance with this section shall be fully docu

57、mented in records that are subject to verification in accordance with120.11(a)(1)(iv)(B) and the recordkeeping requirements o120.11Verification and validation.(a) Verification. Each processor shall verify that the Hazard Analysis and Critical Control Point (HACCP) system is being implemented accordi

58、ng to design.(1) Verification activities shall include:(i) A review of any consumer complaints that have been received by the processor to determine whether such complaints relate to the performance of the HACCP plan or reveal previously unidentified critical control points;(ii) The calibration of p

59、rocess monitoring instruments;(iii) At the option of the processor, the performance of periodic end-product or in-process testing; except that processors of citrus juice that rely in whole or in part on surface treatment of fruit shall perform end-product testing in accordance with 120.25.(iv) A rev

60、iew, including signing and dating, by an individual who has been trained in accordance with of the records that document:(A) The monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that the records document v

61、alues that are within the critical limits. This review 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 appropriate corrective ac

62、tions were taken in accordance with 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 critical control points and the performance of any periodic end-product or in-process testing that is part of

63、the processors verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete and that these activities occurred in accordance with the processors written procedures. These reviews shall occur within a reasonable time after the records are made;

64、 and(v) The following of procedures in .10 whe1n2e0ver any verification procedure, including the review of consumer complaints, establishes the need to take a corrective action; and(vi) Additional process verification if required by 120.25.(2) Records that document the calibration of process monitor

65、ing instruments, in accordance with paragraph(a) (1)(iv)(B) of this section, and the performance of any periodic end-product and in-process testing, in accordance with paragraph (a)(1)(iv)(C) of this section, 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 a