Current Regulations

1. Current Regulations Food Safety

2. HACCP and Regulatory Agencies USDA/FSIS Inspection Meat and Poultry Food and Drug Administration PMO National Advisory Committee for the Microbiological Criteria for Food Federal Meat Inspection Act Poultry Products Inspection act an Egg Products Inspection act Continuous in-plant inspection of slaughter � daily inspection of �further processed� environments Eggs � liquid, frozen and dried FDA � Others Periodic inspections Federal Food Drug and Cosmetic act Pasteurized Milk Ordinance milk � state regulations in addition to FDA �grade A� PMO �prescriptive�, not reactive � revisions will be HACCP -basedFederal Meat Inspection Act Poultry Products Inspection act an Egg Products Inspection act Continuous in-plant inspection of slaughter � daily inspection of �further processed� environments Eggs � liquid, frozen and dried FDA � Others Periodic inspections Federal Food Drug and Cosmetic act Pasteurized Milk Ordinance milk � state regulations in addition to FDA �grade A� PMO �prescriptive�, not reactive � revisions will be HACCP -based

3. Regulatory Requirements for HACCP FDA � Fish and Fisheries USDA/FSIS � Meat and Poultry FDA � Juice �Coming Soon� Fresh Produce Egg

4. Code of Federal Regulations (CFR) Title 9, Parts 416 and 417 USDA/FSIS Meat and Poultry Regulation Addresses: Sanitation HACCP 61 FR 38868 July 25, 199661 FR 38868 July 25, 1996

5. Part 416 - Sanitation Must Develop Written SSOPs Part 416.13 � Implementation Part 416.14 � Maintenance Part 416.15 � Corrective Actions Part 416.16 � Records Part 416.17 � Agency Verification 416.13 � Must conduct pre-op detailed in SSOPs on frequencies specified, monitor implementation 416.14 � Evaluation of effectiveness 416.15 � Corrective Actions 416.16- Records 416.17 � Verification � Agency will verify the adequacy and effectiveness of the SSOP and the procedures described. -Review SSOP Review Daily Records Direct observation of implementation Direct observation of testing 416.13 � Must conduct pre-op detailed in SSOPs on frequencies specified, monitor implementation 416.14 � Evaluation of effectiveness 416.15 � Corrective Actions 416.16- Records 416.17 � Verification � Agency will verify the adequacy and effectiveness of the SSOP and the procedures described. -Review SSOP Review Daily Records Direct observation of implementation Direct observation of testing

6. Part 417 � HACCP Systems 417.2 � Hazard Analysis and HACCP plan Include Flow Chart Requirements Requirements for Hazard Analysis Requirements for HACCP Plans Process Categories Single HACCP plan may cover multiple products Contents of HACCP plan Signing and Dating HACCP Plan Hazard Analysis � Each establishment must conduct a Hazard Analysis to determine if they are �reasonably likely to occur� Flow Chart also included in this section of reg HACCP plan � Each establishment shall develop and implement a written HACCP plan covering each product produced. Hazard Analysis � Each establishment must conduct a Hazard Analysis to determine if they are �reasonably likely to occur� Flow Chart also included in this section of reg HACCP plan � Each establishment shall develop and implement a written HACCP plan covering each product produced.

7. 417.2 � Corrective Actions �Cause of deviation is identified and eliminated The CCP will be under control after the corrective action is taken Measures to prevent recurrence are established No Product that is Injurious to health or otherwise adulterated as a result of the deviation enters commerce�

8. 417.4 � Validation, Verification and Reassessment Validation Initial Ongoing Reassessment of Plan Reassessment of Hazard Analysis Initial Validation � HACCP plan functioning as intended, adequacy of CCPs, CLs, monitoring, and recordkeeping, and corrective actions. Also includes review of records. Ongoing � Equipment calibration Direct observations of monitoring activities and corrective actions Daily review of records Reassessment � At LEAST annually and when any changes occur Reassessment of Hazard Analysis � Reassess when changes occurInitial Validation � HACCP plan functioning as intended, adequacy of CCPs, CLs, monitoring, and recordkeeping, and corrective actions. Also includes review of records. Ongoing � Equipment calibration Direct observations of monitoring activities and corrective actions Daily review of records Reassessment � At LEAST annually and when any changes occur Reassessment of Hazard Analysis � Reassess when changes occur

9. 417.2 Process Categories: Slaughter � all species Raw Product � Ground Raw Product � Not Ground Thermally processed � Commercially Sterile Not heat treated � Shelf Stable Heat Treated � Shelf Stable Fully cooked � Not shelf stable Heat treated but not fully cooked, not shelf stable Product with secondary inhibitors � not shelf stable

10. 417.5 - Records Hazard Analysis HACCP Plan Documentation Time, Date, Signature Pre-Shipment Review Computer Records Record Retention Record Maintenance Hazard Analysis and Documentation HACCP plan (decision making documents, documents supporting monitoring and development of CCPs CL, verification, etc). Documentation of monitoring, CL, actual records generated Time and Date recorded, sign or initial Pre-Shipment review Ideally dated and signed by person who did not generate record Computer Records Ok if controls are implemented to ensure the integrity of electronic data and signatures Record Retention Slaughter and refrigerated � 1 year Frozen, preserved, shelf-stable � two years Off site storage � permitted after 6 m and much be retrieved within 24 hoursRecord Maintenance Hazard Analysis and Documentation HACCP plan (decision making documents, documents supporting monitoring and development of CCPs CL, verification, etc). Documentation of monitoring, CL, actual records generated Time and Date recorded, sign or initial Pre-Shipment review Ideally dated and signed by person who did not generate record Computer Records Ok if controls are implemented to ensure the integrity of electronic data and signatures Record Retention Slaughter and refrigerated � 1 year Frozen, preserved, shelf-stable � two years Off site storage � permitted after 6 m and much be retrieved within 24 hours

11. CFR � Title 21, Part 123 Fish and Fisheries

12. Subpart A � General Provisions 123.3 Definitions 123.5 - CGMPs

13. 123.6 � HACCP Plan Hazard Analysis HACCP Plan Products Subjected to Other Regulations Sanitation Legal Issues Hazard Analysis HACCP Plan location where processing occurs Kind of fish processed by processor Groups of fish can be put into 1 plan together List of Hazards Reasonably likely to occur CCPs CLs Monitoring procedures Corrective Actions Verification procedures Recordkeeping Sign and Date � HACCP plan accepted and implemented by the firm initial modification verification Products subjected to other regs Do NOT need to address C bot in hermetically sealed containers Sanitation Not included in HACCP plan Legal Basis If no HACCP plan, product is adulteratedHazard Analysis HACCP Plan location where processing occurs Kind of fish processed by processor Groups of fish can be put into 1 plan together List of Hazards Reasonably likely to occur CCPs CLs Monitoring procedures Corrective Actions Verification procedures Recordkeeping Sign and Date � HACCP plan accepted and implemented by the firm initial modification verification Products subjected to other regs Do NOT need to address C bot in hermetically sealed containers Sanitation Not included in HACCP plan Legal Basis If no HACCP plan, product is adulterated

14. Subpart A 123.7 � Corrective Actions 123.8 � Verification 123.9 � Records 123.10 � Training 123.11 � Sanitation 123.12 � Special Req for Imported Products CA � No product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation Cause if correction When NO corrective action plan available Segregate and hold the affected product Perform a review Take corrective action with respect to the affected product Corrective action to correct the cause of the deviation Reassessment DOCUMENT all CA Verifications Overall Reassessment when changes occur On-going � after customer complaints Instrument calibrations End-product testing � optional Record review � sign and date monitoring of ccps Taking CAs calibrations Reassessment Recordkeeping Records General Name and location of processor Date and time of activity Signature Id of the product and production code Record Retention 1 year � refrigerated 2 years � frozen, preserved or shelf-stable Must be retained at place of business for 2 years Official Review � FDA may copy at any time Public disclosure NOT available for public disclosure Computers � same as USDA Training At least 1 trained individual/plan Sanitation � NOT required Special � Importer Verification MOU � memorandum of understanding with FDA Competent Verification Procedures CA � No product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation Cause if correction When NO corrective action plan available Segregate and hold the affected product Perform a review Take corrective action with respect to the affected product Corrective action to correct the cause of the deviation Reassessment DOCUMENT all CA Verifications Overall Reassessment when changes occur On-going � after customer complaints Instrument calibrations End-product testing � optional Record review � sign and date monitoring of ccps Taking CAs calibrations Reassessment Recordkeeping Records General Name and location of processor Date and time of activity Signature Id of the product and production code Record Retention 1 year � refrigerated 2 years � frozen, preserved or shelf-stable Must be retained at place of business for 2 years Official Review � FDA may copy at any time Public disclosure NOT available for public disclosure Computers � same as USDA Training At least 1 trained individual/plan Sanitation � NOT required Special � Importer Verification MOU � memorandum of understanding with FDA Competent Verification Procedures

15. Subpart B � Smoked Products 123.15 � General 123.16 � Process Controls MUST address C. botulinum for shelf-life of product under moderate abuse conditions

16. Subpart C � Raw Shellfish 123.20 � General 123.28 � Source Controls Control of Origin US Federal Waters (not Closed) Tag Date of Harvest Location of Harvest Quantity and Type of Fish Name of Harvester