Narrative. Description of Process. REVISED SEPTEMBER 2017 Commercial Processing Example: Wild Salmon Sushi Rolls

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National Seafood HACCP Alliance for Training and Education REVISED SEPTEMBER 2017 Commercial Processing Example: Wild Salmon Sushi Rolls Example: This is a Special Training Model for illustrative purposes only. The SHA models are based on guidance contained in FDA s Fish and Fishery Products Hazards and s Guidance (4 th Edition, 2011) and additional information available since the 2011 edition. It was produced by the National Seafood HACCP Alliance (SHA) strictly as an example for training. This Model does not represent a specific requirement or recommendation from FDA. Keep in mind that this model may not apply to all situations. Narrative Company Market Name Source of Fishery Product Describe the Food Method of Receiving, Storage and Distribution Finished Packaging Type Intended Use and Consumer ABC Sushi Rolls Company, Anywhere, USA Salmon (Oncorhynchus kisutch) Wild caught salmon (frozen); purchased from another processor. Salmon sushi rolls (salmon, rice mixture and seaweed), chilled, packaged in oxygen permeable packaging, Salmon fillets are received frozen, thawed, stored under refrigeration and subsequently distributed under refrigeration. Salmon sushi rolls are placed into plastic trays and covered by an oxygen permeable film. Salmon sushi rolls are an uncooked prepared product (ready to eat), to be consumed by the general public. Description of Process Receive frozen salmon Frozen wild salmon (oceancaught) fillets are received from primary processor. The primary processor freezes the salmon to a temperature of 4 o F/ 20 o C or lower for more than 7 days to kill parasites as required by the company s product specifications. A statement is on file from the supplier verifying that all salmon shipped is provided to ABC Seafood Company indicating the fish have been processed according to the supplier s HACCP plan to eliminate parasites. Frozen salmon storage After receipt, the salmon is held in frozen storage (0 o F or below) until it removed for tempering prior to making sushi rolls. Product can remain in frozen storage for up to two weeks. Preparing salmon Frozen salmon fillets are brought to the preparation room, tempered for about 20 minutes prior to manually cutting into 1 strips. The preparation room temperature is 45 o F/7.2 o C. Receive dry materials Dry seaweed without added ingredients, and 40lb bags of rice are received from approved vendors. Vinegar received with confirmation for sulfite free. Dry Storage Seaweed and rice are stored in original containers in the dry storage area. Cooking rice Rice is removed from the dry storage area and taken to the rice cooking room where it is batch cooked in boiling water until done. Rice acidification Acidification is used to prepare rice with proper texture and to prevent growth of potential pathogenic bacteria, Bacillus cereus. The hot rice is immediately mixed in the cooker with vinegar (sulfitefree) to acidify to a ph of 4.3 or less. Mixing is done manually. Acidified rice is put into 5 gallon insulated containers to keep it warm (80 105 o F/~27 41 o C) so it will roll better. The insulated containers are taken to the sushi prep room which is maintained at 45 o F/7.2 o C. The finished rice is allowed to equilibrate for at least 30 minutes before ph is tested. Assemble nori, rice and salmon into rolls The acidified rice, seaweed (nori) and salmon portions are assembled into sushi rolls in a process that takes less than two hours. The rice is formed into a sheet, the seaweed and salmon Seafood HACCP Models: Wild Salmon Sushi Rolls Page 1 of 13

REVISED SEPTEMBER 2017 are placed on the rice and it is rolled together. Each roll takes about two minutes to assemble. Cut rolls The finished roll is manually sliced into approximately 1 round pieces, using a handheld unbreakable knife. Pack and label All pieces are placed into plastic trays with oxygen permeable film and labeled. National Seafood HACCP Alliance for Training and Education Finished product refrigerated storage The finished packaged sushi product is either placed directly on a refrigerated truck and shipped to the customer the same day or stored in a refrigerated cooler overnight at 40 o F/4.4 o C or less for shipment the next day. SPECIAL NOTE: glassware or glass containers are used in processing the salmon, rice or sushi rolls. The total process time after rice is cooked through the Pack and Label is no more than 2 hours. Wild Salmon Sushi Rolls Process Flow Chart Receive Dry Materials Receive frozen salmon Dry storage of rice Dry storage of seaweed (ri) Frozen storage of salmon Cook rice Preparing salmon Rice acidification Assemble nori, rice and fish into rolls Cut rolls Pack and label Finished product refrigerated storage Seafood HACCP Models: Wild Salmon Sushi Rolls Page 2 of 13

National Seafood HACCP Alliance for Training and Education Commercial Processing Example: Wild Salmon Sushi Rolls Example: For Illustrative Purposes Only. Models are based in current guidance contained in FDA s Fish and Fishery Products Hazards and Guidance. Keep in mind that this model does not apply to all situations. Description Company: ABC Sushi Rolls Company Fish or Shellfish Species Where Product Is Purchased From Fisherman From Fish Farm From Processor Refrigerated How Product Is Received Iced Frozen Shelf-Stable Refrigerated How Product Is Stored Iced Frozen Shelf-Stable Refrigerated How Product Is Shipped Iced Frozen Shelf-Stable How Product is Packaged Air Packed ROP* How Product Will Be Consumed Raw to be cooked Raw RTE* Cooked RTE* Intended Consumer General Public At Risk Population Common Name: Salmon (wild) Market Name: Salmon Scientific Name: Oncorhynchus kisutch *ROP = Reduced Oxygen Packaging; *RTE = Ready to Eat Potential Food Safety Hazards: All potential food safety hazards based on the product description and processing flow diagram associated with this product and process are identified using Tables 3 2 (speciesrelated hazards) and 3 4 (process related hazards) in the FDA Hazards and s Guidance (2011 edition). Processors should be aware that additional guidance may be periodically posted on FDA Seafood HACCP Websites, and additional hazards not covered by this guidance may be relevant to certain products under certain circumstances. The FDA recommendations indicate 5 potential hazards that that are species or process related. Each potential hazard must be addressed in the Hazard Analysis. Glass Inclusion as listed in the FDA Guidance Table 3 4 Process related hazards was not included because no glassware or glass containers are used in processing the salmon, rice or sushi rolls. 1. Parasites (species related, chapter 5) 2. growth (thermal during processing) (process related, chapter 12) [NOTE: Although not specifically listed in the FDA Tables for potential hazards, pathogen growth in cooked rice should be included as a potential hazard for this particular product (mentioned on FDA Guidance page 217)] 3. Food Allergens (natural) (process related, chapter 19) 4. Food Additives (use of sulfites to control melanosis) (process related, chapter 19) 5. (if used in packaging ) (process related, chapter 20) SANITATION CONTROL PROCEDURES (SCP) are monitored throughout all processing s and the daily SCP records accompany the HACCP records. Seafood HACCP Models: Wild Salmon Sushi Rolls Page 3 of 13

REVISED SEPTEMBER 2017 Hazard Analysis Worksheet National Seafood HACCP Alliance for Training and Education Firm Name: ABC Sushi Rolls Company Product Description: Salmon sushi rolls in oxygen permeable packages Firm Location: Anywhere, USA Method of Storage & Distribution: Refrigerated at 40 F Intended Use & Consumer: Ready-to-eat uncooked prepared product, to be consumed by general public without further cooking (1) Processing Step Receive dry ingredients and packaging materials (2) List all potential food safety hazards that could be associated with this product and process. Parasites Food Allergens (3) Is the potential food safety hazard significant (introduced, enhanced or eliminated) at this? (Yes or ) (4) Justify the decision that you made in column 3 t reasonably likely to occur in ingredients or packaging t reasonably likely to occur in ingredients or packaging t reasonably likely to occur in ingredients or packaging (5) What control measure(s) can be applied to prevent this significant hazard? (6) Is this a Critical Point? (Yes or ) Food Additives additives used Dry Storage Parasites Food Allergens t reasonably likely to occur at this t reasonably likely to occur in dry storage t reasonably likely to occur in dry storage t reasonably likely to occur in dry storage Food Additives additives used t reasonably likely to occur at this Parasites led by supplier with freezing Receive frozen salmon growth- temperature t reasonably likely in frozen salmon Food Allergens Yes Salmon is a food allergen Finished product label applied at pack and label will identify fish market name (salmon). Food Additives additives used Metal inclusion is not likely to occur at this Seafood HACCP Models: Wild Salmon Sushi Rolls Page 4 of 13

National Seafood HACCP Alliance for Training and Education (1) Processing Step (2) List all potential food safety hazards that could be associated with this product and process. (3) Is the potential food safety hazard significant (introduced, enhanced or eliminated) at this? (Yes or ) (4) Justify the decision that you made in column 3 (5) What control measure(s) can be applied to prevent this significant hazard? (6) Is this a Critical Point? (Yes or ) Parasites led by supplier with freezing growth temperature t likely to occur in frozen salmon Frozen Storage Food Allergens Yes Salmon is a food allergen Finished product label applied at pack and label will identify fish market name (salmon). Food Additives additives used Parasites t reasonably likely to occur at this t reasonably likely to occur in cooked rice t reasonably likely to occur during cooking Cook rice Food Allergens Rice is not a major food allergen Food Additives additives used Parasites t reasonably likely to occur at this t reasonably likely to occur in rice or acidified rice Rice acidification Yes Bacillus cereus could grow and form toxins if cooked rice is timetemperature d Food Allergens Rice is not a major food allergen Rice acidification Yes Food Additives additives used ; vinegar (sulfitefree) is not a food additive t reasonably likely to occur at this Seafood HACCP Models: Wild Salmon Sushi Rolls Page 5 of 13

REVISED SEPTEMBER 2017 (1) Processing Step (2) List all potential food safety hazards that could be associated with this product and process. (3) Is the potential food safety hazard significant (introduced, enhanced or eliminated) at this? (Yes or ) (4) Justify the decision that you made in column 3 National Seafood HACCP Alliance for Training and Education (5) What control measure(s) can be applied to prevent this significant hazard? (6) Is this a Critical Point? (Yes or ) Parasites led by supplier with freezing t reasonably likely to occur because of short time at this in separate, chilled room Preparing salmon Food Allergens Yes Salmon is a food allergen Finished product label applied at pack and label will identify fish market name (salmon). Food Additives additives are used t reasonably likely to occur at this Parasites led by supplier with freezing Assemble nori, rice and fish into rolls t reasonably likely to occur due to short time at this in separate, chilled room Food Allergens Yes Salmon is a food allergen Finished product label applied at pack and label will identify fish market name (salmon). Food Additives additives are used t reasonably likely to occur at this Parasites led by supplier with freezing t reasonably likely to occur due to short time at this in separate, chilled room Cut Rolls Food Allergens Yes Salmon is a food allergen Finished product label applied at pack and label will identify fish market name (salmon). Food Additives additives are used t reasonably likely to occur at this (using special cutting blades) Seafood HACCP Models: Wild Salmon Sushi Rolls Page 6 of 13

National Seafood HACCP Alliance for Training and Education (1) Processing Step (2) List all potential food safety hazards that could be associated with this product and process. (3) Is the potential food safety hazard significant (introduced, enhanced or eliminated) at this? (Yes or ) (4) Justify the decision that you made in column 3 (5) What control measure(s) can be applied to prevent this significant hazard? (6) Is this a Critical Point? (Yes or ) Parasites led by supplier with freezing t reasonably likely to occur due to short time at this in separate, chilled room Pack and Label Food Allergens Yes Salmon is a food allergen Finished product label applied at pack and label will identify fish market name (salmon). Yes Food Additives additives are used t reasonably likely to occur at this Parasites led by supplier with freezing Finished product refrigerated storage Food Allergens Yes Pathogens can grow in storage if rolls exposed to temperature conditions Undeclared allergens not reasonably likely to occur; already controlled at the pack and label. Time and temperature controls Yes Food Additives additives are used t reasonably likely to occur at this Seafood HACCP Models: Wild Salmon Sushi Rolls Page 7 of 13

REVISED SEPTEMBER 2017 Wild Salmon Sushi Rolls Process Flow Chart Shaded s are critical control points National Seafood HACCP Alliance for Training and Education Receive Dry Materials Receive frozen salmon Dry storage of rice Dry storage of seaweed (ri) Frozen storage of salmon Cook rice Preparing salmon Rice acidification CCP 1 Assemble nori, rice and fish into rolls Cut rolls Pack and label CCP 2 Finished product refrigerated storage CCP 3 Seafood HACCP Models: Wild Salmon Sushi Rolls Page 8 of 13

National Seafood HACCP Alliance for Training and Education Firm Name ABC Sushi Rolls Company HACCP Plan Form Product Description Salmon sushi rolls in oxygen permeable packaging Firm Location Anywhere USA Method of Storage & Distribution Intended Use & Consumer Refrigerated below 40 F/4.4 C Ready to eat product, to be consumed by the general public without further cooking Critical Point (CCP) Significant Hazard(s) Critical Limits for each Measure What CCP 1: RICE ACIDIFICATION. (Bacillus cereus) Equilibration time of acidification is 30 minutes or more. ph of rice is 4.3 or less Time of acidification and ph of rice Monitoring How When Who Clock and ph meter Each batch Quality person Corrective Action Verification Records If the equilibration time is not met, then the rice will be on hold until it reaches the 30 minute timeframe. Evaluate production procedures to prevent future recurrences. Retrain staff. If the ph is not 4.3 or less; then add more vinegar and re-check the ph; allow full equilibration time. Evaluate rice acidification formula to prevent future recurrences. Retrain involved staff. Daily review of monitoring and corrective action records; Prior accuracy check for ph meter standardized per batch, and ph meter calibration as required by manufacturer. Study on file that validates the equilibration time to yield a stable ph of less than or equal to 4.3 Acidification record; Corrective Actions and ph meter calibration and accuracy log; training record. Signature: Date: Seafood HACCP Models: Wild Salmon Sushi Rolls Page 9 of 13

REVISED SEPTEMBER 2017 HACCP Plan Form National Seafood HACCP Alliance for Training and Education Firm Name ABC Sushi Rolls Company Firm Location Anywhere USA Product Description Salmon sushi rolls in oxygen permeable packaging Method of Storage & Distribution Intended Use & Consumer Refrigerated below 40 F/4.4 C Ready to eat product, to be consumed by the general public without further cooking Critical Point (CCP) Significant Hazard(s) Critical Limits for each Measure What CCP 2: PACK AND LABEL Food Allergens Labels on finished product packages include the market name salmon in the ingredient list. Finished product labels Monitoring How When Visual checks of ingredient list on finished product label Representative sample of finished product containers from each lot. Who Packing Supervisor Corrective Action Verification Records If the label does not have salmon in the ingredient list Then segregate and re-label incorrectly labeled product Review and modify label procedures as necessary. Retrain involved staff. Daily review of monitoring and corrective action records for time sensitive product Pack room report; Corrective Actions; training records. Signature: Date: Seafood HACCP Models: Wild Salmon Sushi Rolls Page 10 of 13

National Seafood HACCP Alliance for Training and Education Firm Name ABC Sushi Rolls Company HACCP Plan Form Product Description Salmon sushi rolls in oxygen permeable packaging Firm Location Anywhere USA Method of Storage & Distribution Intended Use & Consumer Refrigerated below 40 F/4.4 C Ready to eat product, to be consumed by the general public without further cooking Critical Point (CCP) CCP 3: FINISHED PRODUCT REFRIGERATED STORAGE Significant Hazard(s) Critical Limits for each Measure What Cooler at 40 o F/4.4 o C or below Cooler temperature Monitoring How When Continuous time and temperature recorder Continuous with visual checks at least once per day Who Shift Supervisor Corrective Action If cooler temperature is above 40 o F/4.4 o C, then move product to another cooler or ice and hold for evaluation for exposure. Adjust or repair cooler as necessary. Evaluate product safety by determining cumulative exposure temperature and time above 40 o F/4.4 o C. Destroy if necessary. Retrain involved staff. Verification Records Weekly review of monitoring and corrective action records. Calibrate temperature recorder once per year Check accuracy of time temperature recorder daily. Cooler temperature log and time temperature recording chart; Corrective Actions; training records Signature: Date: Seafood HACCP Models: Wild Salmon Sushi Rolls Page 11 of 13

REVISED SEPTEMBER 2017 Firm Name ABC Sushi Rolls Company Firm Location Anywhere USA HACCP Plan Form (landscape format) Product Description Salmon sushi rolls in oxygen permeable packaging Method of Storage & Distribution Refrigerated below 40 F/4.4 C National Seafood HACCP Alliance for Training and Education Intended Use & Consumer Ready to eat product, to be consumed by the general public without further cooking Critical Point (CCP) Significant Hazard(s) Critical Limits for each Measure Monitoring What How When Who Corrective Action Verification Records Rice Acidification Pathogenic bacteria growth temperature. (Bacillus cereus) Equilibration time of acidification is 30 minutes or more. ph of rice is 4.3 or less Time of acidification and ph of rice Clock and ph meter Each batch Quality person If the equilibration time is not met, then the rice will be on hold until it reaches the 30 minute timeframe. Evaluate production procedures to prevent future recurrences. Retrain staff. If the ph is not 4.3 or less; then add more vinegar and re-check the ph; allow full equilibration time. Evaluate rice acidification formula to prevent future recurrences. Retrain involved staff. Daily review of monitoring and corrective action records; Prior accuracy check for ph meter standardized per batch, and ph meter calibration as required by manufacturer. Study on file that validates the equilibration time to yield a stable ph of less than or equal to 4.3 Acidification record; Corrective Actions and ph meter calibration and accuracy log; training record. Pack and Label Food Allergens Labels on finished product packages include the market name salmon in the ingredient list. Finished product labels Visual checks of ingredient list on finished product label Representative sample of finished product containers from each lot. Packing supervisor If the label does not have salmon in the ingredient list Then segregate and re-label incorrectly labeled product Review and modify label procedures as necessary. Retrain involved staff. Daily review of monitoring and corrective action records. Pack room report; Corrective Actions; training records. Seafood HACCP Models: Wild Salmon Sushi Rolls Page 12 of 13

National Seafood HACCP Alliance for Training and Education REVISED SEPTEMBER 2017 Critical Point (CCP) Significant Hazard(s) Critical Limits for each Measure Monitoring What How When Who Corrective Action Verification Records Finished Product Refrigerated Storage Pathogenic bacteria growth temperature Cooler at 40 o F/4.4 o C or below Cooler temperatu re Continuous time and temperature recorder Continuous with visual checks at least once per day Shift Supervisor If cooler temperature is above 40 o F/4.4 o C, then move product to another cooler or ice and hold for evaluation for exposure. Adjust or repair cooler as necessary. Evaluate product safety by determining cumulative exposure temperature and time above 40 o F/4.4 o C. Weekly review of monitoring and corrective action records. Calibrate temperature recorder once per year Check accuracy of time temperature recorder daily. Cooler temperature log and time temperature recording chart; Corrective Actions; training records Destroy if necessary. Retrain involved staff. Signature: Date: Seafood HACCP Models: Wild Salmon Sushi Rolls Page 13 of 13