1. Chapter 12 The Seafood HACCP Regulation

2. Objective In this module, you will learn: u What are the requirements of the seafood HACCP regulation u How to reference the specific requirements

3. Regulation Format u Subpart A - General provisions –123.3Definitions –123.5Current GMPs –123.6HACCP plan –123.7Corrective actions –123.8Verification –123.9Records –123.10Training –123.11Sanitation control procedures –123.12Special requirements for imported products u Subpart B - Smoked and smoke- flavored fishery products –123.20General –123.16Process controls u Subpart C - Raw molluscan shellfish –123.20General –123.28Source controls

4. Definitions (§123.3) u certification number u critical control point u critical limit u fish u fishery product u hazard u importer u molluscan shellfish u preventive measure u process-monitoring equipment u processing u processor u scombroid toxin-forming species u shall u shellfish-control authority u shellstock u should u shucked shellfish u smoked or smoke-flavored fishery products u tag

5. Fish u Freshwater or saltwater finfish, crustacea, aquatic animal life (including alligators, frogs, aquatic turtles, jellyfish, sea cucumbers, sea urchins, and roe) other than birds or mammals, and all mollusks, where such animal life is intended for human consumption

6. Fishery Product u Any human food product where fish is a characterizing ingredient

7. Importer u The U.S. owner/consignee or the U.S. agent/representative of the foreign owner/consignee at the time of the product’s entry into the United States

8. Processor u Any person engaged in commercial, custom or institutional processing of fish or fishery products either in the United States or in a foreign country

9. Processing u Handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading or holding fish or fishery products

10. Shall u Used to state mandatory requirements

11. Should u Used to state recommended or advisory procedures or to identify recommended equipment

12. Who must comply? u Importer u Processor - domestic and foreign

13. This regulation does not apply to: u The harvest or transport of fish or fishery products u Practices such as heading, eviscerating or freezing intended solely to prepare a fish for holding on a harvest vessel u The operation of a retail establishment

14. Current Good Manufacturing Practices §123.5 u Regulations found in Title 21, Part 110 of the Code of Federal Regulations u Proper practices for the safe and sanitary handling of all foods

15. Hazard Analysis §123.6(a) u Every processor shall conduct or have conducted a hazard analysis u Two major steps in hazard analysis –Determine whether there are hazards that are reasonably likely to occur –Identify preventive measures to control the identified hazards

16. Hazards u Hazards that are “reasonably likely to occur” are those “for which a prudent processor would establish controls” u Decision is based on: –Experience –Illness data –Scientific reports –Other information (e.g., Hazards and Control Guide)

17. HACCP Plan §123.6(b) u Every processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food-safety hazards that are reasonably likely to occur

18. A HACCP plan shall be specific to: u Each processing location u Each species of fish and type of fishery product

19. The HACCP plan shall: u List the food safety hazards that are reasonably likely to occur u List the CCPs u List the critical limits u List the monitoring procedures u List predetermined corrective-action plans* u List the verification measures u Provide for a system of monitoring records *Processors are not required to predetermine corrective actions

20. Signing and Dating the HACCP Plan §123.6(d) u The HACCP plan shall be signed and dated by the most responsible individual at the processing facility or a higher level official of the processor u This signature shall signify that the HACCP plan has been accepted for implementation by the firm

21. The HACCP plan shall be signed and dated: u Upon initial acceptance u Upon any modification* u At least annually* *This is a verification requirement

22. Low Acid Canned Foods and Acidified Foods §123.6(e) u Processors who comply with 21CFR Part 113 or 21CFR Part 114 do not need to address the hazard of Clostridium botulinum in their HACCP plans u Other hazards reasonably likely to occur in acidified or low acid canned fishery product must be addressed in the HACCP plan as appropriate (e.g., histamine in canned tuna)

23. Sanitation Controls and the HACCP Plan §123.6(f) u Sanitation controls are not required to be included in the HACCP plan u Sanitation controls that are not part of the HACCP plan must be monitored according to the sanitation provisions of the regulation

24. Legal Basis §123.6(g) u FDA’s application of HACCP is primarily based on the Federal Food Drug and Cosmetic Act u Any fish or fishery products processed or imported in violation of this regulation can be considered adulterated and subject to regulatory action

25. Corrective Action §123.7 u Whenever a deviation from a critical limit occurs, a processor shall take corrective action

26. Corrective Actions - Two Choices u Predetermined u Alternate Procedure –Segregate and hold product –Determine product acceptability –Apply corrective action to product and process –Reassess the HACCP plan

27. Verification §123.8 u Every processor shall verify: –That the HACCP plan is adequate to control the food safety hazards that are reasonably likely to occur –That the HACCP plan is implemented effectively

28. Ongoing Verification u Consumer complaint review u Calibration of process-monitoring instruments u Periodic end-product and in-process testing (processor’s option)

29. Review of Records u CCP monitoring records u Corrective-action records u Calibration records u In-process and end-product testing records

30. Records §123.9 u Records required by the regulation: –Monitoring records –Corrective-action records –Verification records –Sanitation-control records –Importer-verification records

31. Required information on each record u Name and location of the processor or importer u Date and time of the activity being recorded u Signature or initials of the person making the record u Where appropriate, identity of the product and the production code if any

32. Record retention u One year for refrigerated products u Two years for frozen or preserved products

33. Training § 123.10 u The HACCP-trained individual shall: –Develop the HACCP plan –Reassess and modify the HACCP plan and hazard analysis –Review HACCP records

34. Sanitation §123.11 u Prerequisite program u Required even if a processor determines there is no need for a HACCP plan u May be part of the HACCP plan or managed separately

35. General Sanitation Requirement u Current GMP regulations are the standard for proper sanitation conditions and practices u Eight key sanitation conditions and practices u Mandatory sanitation monitoring with record keeping u Mandatory corrections with record keeping u Recommended SSOP

36. Eight key sanitation conditions/practices u Safety of water u Condition and cleanliness of food-contact surfaces u Prevention of cross- contamination u Maintenance of hand- washing, hand-sanitizing and toilet facilities u Protection from adulterants u Labeling, storage and use of toxic compounds u Employee health conditions u Exclusion of pests

37. Imported Products §123.12 u HACCP controls are required for imported fish and fishery products as well as for domestic products

38. Importer Verification u Import from countries with a memorandum of understanding (MOU), or u Implement verification procedures

39. Importer Verification Procedures u Product specifications and u Affirmative steps

40. Importer Verification Procedures Affirmative steps may include any of the following: u Obtain foreign processor’s HACCP and sanitation monitoring records for the lot being entered u Obtain continuing or lot-by-lot certificate from competent third party u Regularly inspect foreign processor u Obtain foreign processor's HACCP plan and written guarantee that regulation is being met u Test the product and obtain written guarantee that regulation is being met u Perform other verification procedures that provide equivalent level of assurance

41. Smoked and Smoke-Flavored Fishery Products §123.15 and §123.16 u HACCP plan must include controls for Clostridium botulinum toxin formation for the shelf life of the product under normal and moderate abuse conditions u Where product is subject to 21 CFR 113 or 114, the HACCP plan need not include such controls

42. Raw Molluscan Shellfish §123.20 u HACCP plans must include a means for controlling the origin of the raw molluscan shellfish u Where processing includes a treatment that ensures the destruction of vegetative cells of microorganisms of public health concern, the HACCP plan need not include controls on sources of origin

43. Raw Molluscan Shellfish §123.28 Processors shall only process molluscan shellfish from: u Growing waters approved by a shellfish- control authority u Federal growing waters not closed by an agency of the federal government

44. Raw Molluscan Shellfish §123.28 Shellstock Receiving: u If source is a harvester, harvester must be in compliance with any license requirement u If source is another processor, processor must be certified by a shellfish-control authority u Containers of shellstock must be properly tagged

45. Raw Molluscan Shellfish §1240.60 Required information on tag: u Date and place shellfish were harvested (state and site) u Type and quantity of shellfish u Harvester identification number, name of harvester, or name or registration number of harvester’s vessel

46. Raw Molluscan Shellfish §123.28 Records for shellstock receiving must document: u Date of harvest u Location of harvest by state and site u Quantity and type of shellfish u Date of receipt by the processor u Name of harvester, name or registration number of harvester’s vessel or harvester’s identification number

47. Raw Molluscan Shellfish §123.28 Shucked molluscan shellfish containers must bear a label that contains: u Name of packer or repacker u Address of packer or repacker u Certification number of packer or repacker

48. Raw Molluscan Shellfish §123.28 Records for shucked product must document: u Date of receipt u Quantity and type of shellfish u Name and certification number of the packer or repacker