Green Aquaponics LLC as a ModelDecoupled aquaponic process flow diagram. A Guide to the Aquaponics Food Safety Plan Development: Green Aquaponics LLC as a Model. 2 Table 1. Product

Publication FST-302P

A Guide to the Aquaponics Food Safety Plan Development:

Green Aquaponics LLC as a Model

Publication FST-302P/VSG-18-6

A Guide to the Aquaponics Food Safety Plan Development: Green Aquaponics LLC as a Model

Mahmoudreza Ovissipour, Assistant Professor and Extension Specialist, Seafood Agriculture Research and Extension Center, Department of Food Science and Technology, Virginia Tech

Barbara Rasco, Professor and Director, School of Food Science, Washington State UniversityGleyn Bledsoe, Adjunct Professor, Washington State University

Setareh Shiroodi, Postdoctoral Associate in Food Safety, Seafood Agricultural Research and Extension Center, Virginia Tech

DISCLAIMER: The plan provides an example of best practices. It is for training purposes only and does not represent any specific operation. Development of a food safety plan is site-specific, and plans for each location should be developed separately.

This model includes both required and optional information to illustrate how a food safety plan might be designed under regulations in 21 Code of Federal Regulations (CFR) Parts 112, 117, and 123, associated with the Food Safety Modernization Act (Public Law (PL) 111-353). Conditions and specifications used (e.g., validation information) are for illustrative purposes only and may not represent actual process conditions.

www.ext.vt.eduProduced by Virginia Cooperative Extension, Virginia Tech, 2019

Virginia Cooperative Extension programs and employment are open to all, regardless of age, color, disability, gender, gender identity, gender expression, national origin, political affiliation, race, religion, sexual orientation, genetic informa-tion, veteran status, or any other basis protected by law. An equal opportunity/affirmative action

employer. Issued in furtherance of Cooperative Extension work, Virginia Polytechnic Institute and State University, Virginia State University, and the U.S. Department of Agriculture cooperating. Edwin J. Jones, Director, Virginia Cooperative Extension, Virginia Tech, Blacksburg; M. Ray McKinnie, Administrator, 1890 Extension Program,

Virginia State University, Petersburg.

VT/0119/FST-302P/VSG-18-6

1

Company Overview Green Aquaponics LLC. was established in 2000 as an aquaculture farm in Idaho, first developed for producing fish, specifically male blue tilapia (Tilapia aurea) and in 2010, Green Aquaponics coupled its indoor aquaculture system with an indoor fresh produce production unit into an aquaponics system and expanded operations to their Washington facility in Aquatown. This company produces lettuces on rafts in a recirculation system. The aquaculture capacity is 10,000 lb of tilapia per year. The hydroponic area is 12,000 square feet in an indoor production system with an indoor raft system producing approximately 90,000 lb per year presuming a harvestable crop of lettuce every 4 weeks after transplant. The first harvestable fish follow in 9 months and are then harvested monthly based upon market demand. The water source is tested potable well water that feeds the aquaculture section, and after passing through the aquaculture section proceeds through a biofilter converting ammonia to nitrate providing water for irrigating the fresh produce. Water quality entering the produce unit is tested at least monthly to ensure that it meets requirements under the Produce Safety Rule. The light source is partially from natural light plus LED based artificial lighting.

The company sells live fish to local restaurants and whole fish (bled and eviscerated), shipped on fresh water ice, to local distributers and retailers. Lettuce is packed in plastic clamshells or plastic-coated cardboard boxes with ice as needed and then shipped to local distributers.

Product DescriptionsTable 1. Product description for fresh/whole on-ice fish. (See page 2)

Table 2. Product description for live fish. (See page 3)

Table 3. Product description for lettuce. (See page 4)

Figure 1: Coupled Aquaponic Process Flow Diagram

Figure 2: Decoupled Aquaponic Process Flow Diagram

Product Descriptions Flow Diagrams

Coupled Aquaponic Process Flow Diagram

Figure 1. Coupled aquaponic process flow diagram.

Decoupled Aquaponic Process Flow Diagram

Figure 2. Decoupled aquaponic process flow diagram.

A Guide to the Aquaponics Food Safety Plan Development: Green Aquaponics LLC as a Model

2

Table 1. Product description for fresh/whole on-ice fish.

Food Safety Plan – Product Description, Distri-bution, Consumers, and Intended Use

Blue tilapia (Tilapia aurea) – Whole on ice

Green Aquaponics LLC, 456 River Way, Aquatown, WA 98765

Approved by: P. GreenSignature: P. Green Peter Green, Processing Manager

Version 2: Sept. 9, 2018

Supercedes: Version 1: Aug. 1, 2017

Product Name Blue tilapia – Fresh, whole on ice

Product Description, Including Important Food Safety Characteristics

Ingredients Fish: blue tilapia (Tilapia aurea)

Packing Used Polystyrene boxes (25-lb. net weight fish) with potable water ice. Boxes are sealed with tape having company logo as a tamper-evident feature and have printed lot code, species, weight, date of harvest, and company address information.

Intended Use Fresh tilapia sold to retailers, restaurants, proces-sors

Intended Consumers General public, to be cooked prior to consumption

Shelf Life 5-7 days at 37-45 F/3-7 C

Allergens Fish: tilapia

Labeling Instructions Keep refrigerated (37-45 F/3-7 C). Contains fish (tilapia) to be cooked prior to consumption.

Other Labeling (as applicable) Lot number, best use-by date, intact container sealing tape as tamper-evident feature. Species listed (allergen warning).

Storage and Distribution Keep refrigerated (37-45 F/3-7 C)

Approved: P. GreenSignature: P. Green Peter Green, Processing Manager

Date: 09.09.2018

3

Table 2. Product description for live fish.


Blue tilapia (Tilapia aurea) – Live


Approved by: P. GreenSignature: P. GreenPeter Green, Processing Manager



Product Name Blue tilapia – Live


Ingredients Fish: tilapia

Packing Used Stainless steel fish tanks containing potable well water, with air bubblers or oxygen injectors used during transport as needed. For short-term trans-port, tanks are filled one-third full. Headspace provides sufficient oxygen for the fish during short hauls. Tanks are sealed with a numbered seal. Accompanying documentation includes lot code, harvest date, number and fish weight, company contact information.

Intended Use Live tilapia sold to restaurants for consumption by the general public

Intended Consumers General public, to be cooked prior to consumption

Shelf Life 14 days at 69-77 F (20-25 C) in restaurant aquar-ium

Allergens Fish: tilapia

Labeling Instructions Keep live in freshwater tank; to be cooked prior to consumption

Other Labeling (as applicable) Lot number, best use-by date, intact container seal as tamper-evident feature

Storage and Distribution Keep live and use within 2 weeks

Approved: P. GreenSignature: P. Green Peter Green, Processing Manager

Date: 09.09.2018

4

Table 3. Product description for lettuce.


Lettuce, buttercrunch





Product Name Lettuce, buttercrunch


Ingredients Lettuce, buttercrunch

Packing Used Individually packaged in plastic clamshells with a lot code and tamper-evident tape seal or plas-tic-coated boxes for retail sale. Potable water ice added as needed to maintain quality.

Intended Use Fresh lettuce sold via retailer as whole heads

Intended Consumers General public

Shelf Life 7-10 days after packing under refrigeration

Allergens Water source is also used for fish. Allergen risk unlikely, but lettuce retailers should consider label-ing the products as being produced in a system in which tilapia are also grown. Lettuce and tilapia are processed in the same facility with operations physically segregated by walls and separate en-tries to reduce the risk of allergen cross-contact.

Labeling Instructions Keep refrigerated (40-50 F/4-10 C). Allergen warning: Processed in an aquaponics facility that raises fish (tilapia).

Other Labeling (as applicable) Lot number, best use-by date, intact tape on clam-shell as tamper-evident feature, company contact information

Storage and Distribution Refrigerated (40-50 F/4-10 C)

Approved: P. GreenSignature: P. GreenPeter Green, Processing Manager

Date: 09.09.2018

5

Process Descriptions

Fish ProductionReceive tilapia (fingerlings from fish fingerling producers): Healthy blue tilapia (Tilapia aurea) fingerlings are transported in trailers equipped with oxygenation tanks from a licensed fish breeder. Fingerlings are inspected for quality, lack of disease, and presence of parasites before a lot number is assigned. Health certificates are received for each lot of fingerlings. Health certificates are required from the suppliers as a condition of purchase.

Receive fish feed: Fish feed is received in 50-pound bags from fish feed producers, and the bags are checked for any physical defects. Date of feed production, date of expiration, lot number, feed ingredients, and the chemical composition of the feeds are also checked for nutritional quality and for any unanticipated allergens. We inspect our feed producer annually as part of our approved supplier program. Feed comes with a certificate of analysis. Feed is sent out quarterly for analysis for pathogens (e.g., Salmonella spp.) and allergens (e.g., soy, wheat) and for nutrient profile. We do not use medicated feed or animal drugs in the cultivation of the tilapia in this facility.

Fish feed storage: All fish feed bags are stored at a temperature below 90 degrees Fahrenheit (F)/32 degrees Celsius (C) in a storage room, where they are covered and kept on pallets off the floor, isolated from the lettuce production unit and lettuce processing area. To avoid cross-contamination, feeds with allergenic components are stored together and labeled as such. Fish feeds containing plant- and animal-based proteins that might be allergenic are segregated and stored in a separate storage area. A trained employee conducts daily pest control inspections of the feed storage room, and pest control is contracted to an outside firm that visits the facility on a monthly basis.

Well water: Well water is treated with UV or ozone prior to entering the fish tanks. Median well water temperature is 50 F/10 C. The water samples are tested every week for total coliforms (<4 CFU/ml) and presence or absence of Escherichia coli, Listeria monocytogenes, Salmonella spp., and Vibrio spp. The intensity of UV light is checked weekly to monitor remaining bulb life following the manufacturer’s recommendations. If ozone is used, the concentration is tested daily using a calibrated, dissolved ozone monitor. Surface fouling of the UV system is monitored daily, and fouling is removed as needed.

Fish culturing: Fish fingerlings are introduced into previously cleaned tanks containing clean potable water from the well. Well water is tested on a continuous real-time basis for temperature, pH, and oxygen. Daily tests are conducted for oxygen reduction potential; weekly tests are conducted for E. coli, Salmonella spp., and Listeria monocytogenes; monthly tests are conducted for ammonia, nitrite, and sulfide; and yearly tests are conducted for arsenic. Tanks are monitored every day for dead fish, and if there are any, they are removed from the tanks, the loss is recorded, and a visual exam for signs of disease is conducted. Fish feeding is conducted using an automatic fish feeder to eliminate the human error of overfeeding, missed feedings or cross contamination (from human to feed and from human hands to lettuce after touching the feed). Feeding is controlled because overfeeding results in more solid waste and higher ammonia concentrations. Workers pose a risk of introducing fungal disease to the fish from their hands. During handling of the fish, workers are required to wash and sanitize their hands. Workers are also required to wear the personal protection equipment necessary for the job.

Farm animals, specifically dogs, are kept away from fish tanks and out of the production areas. Cultivation areas are covered with netting to reduce the risk of contamination from birds and bird predation.

Fish and Plants Processing Flow Diagram

Figure 3: Fish and Plants Processing Flow Diagram Figure 3. Fish and plants processing flow diagram.

6

Solids removal filters: After fish tanks, there are solid removal filters to remove fish fecal matter and uneaten feed from the aquaculture system. These solid materials are collected and then further processed into compost.

Solids waste recovery: Solid waste materials (e.g., dead fish) are recovered and are acid-hydrolyzed to a liquid form and used to provide nutrients to plants. Hydrolysate could be added to irrigation water and passed through a UV treatment system to inactivate any pathogens that may be present prior to its use. Fish hydrolysate can also be used as a fertilizer for plants grown in soil off-site as it meets the criteria for organic fertilizer. In addition, the waste can be digested through anaerobic digestion.

Biofilters: Biofilters convert ammonia to nitrite, and nitrite to nitrate. Nitrate is 400 times less toxic to fish than ammonia and can be utilized by plants as a nitrogen source. Nitrosomonas spp. convert ammonia to nitrite, and Nitrobacter spp. convert nitrite to nitrate. It takes 4.5 grams of oxygen to convert 1 gram of ammonia to nitrate. The survival of the two types of bacteria in biofilters depends on maintaining a proper dissolved oxygen level (at least 2 mg/L), pH (above 7), alkalinity (50-100 mg/L CaCO3), and temperature (around 68 F/20 C). Hence, oxygen is provided by a U-tube or a blower into the biofilter system. Water recovered off the biofilters is passed through a UV unit or treated with ozone and then used for irrigating the lettuce. Water quality is tested to ensure that it meets chemical and microbial quality (i.e., turbidity, aroma, appearance) before being used for irrigation. Testing is conducted so water is shown to meet water quality standards for irrigation water under 21 CFR Part 112.

Fish depuration: Tilapia are transferred to separate tanks and held in fresh water for three to five days to empty gut contents and to remove any benthic off-flavors from the flesh that may have resulted from cultivation in a recirculating system. Microbial quality of the water is tested. Fresh water in the tanks is exchanged every two days or more frequently if fish stocking density is high.

Fish harvesting: Fish are harvested directly from the tanks with a net by workers wearing clean uniforms, clean gloves, and personal protective equipment. Fish are transferred to either the live shipments tanks or to totes for transport to the whole fish processing room. The processing room is air conditioned to a temperature of less than 50 F/10 C and held

under positive pressure relative to the outside to reduce the risk of environmental airborne microbial contamination. Sanitary potable ice is on hand to keep the fish cold if ambient temperatures are high.

Live fish processing and shipping: Fish are taken from the tanks with nets that have a load cell to measure weight, and they are transferred directly to the live hold tanks for shipment. Live hold tanks are cleaned and sanitized following each shipment and inspected prior to filling for odor or indications that the tanks have not been adequately cleaned. Tanks are affixed with a numbered seal that is recorded and sent in advance to the customer for verification upon arrival; this is part of our traceability and food defense programs. If air or oxygen is needed for any shipment, food-grade gas that has been sourced from an approved supplier is used. Any fixtures or devices used for aeration are cleaned and sanitized prior to each shipment. Temperature during shipment is controlled to maintain fish quality.

Whole fish processing and shipping: Fish are received from the production unit and are handled by workers who wear gloves, clean uniforms, hair coverings, and personal protection equipment. Fish are stunned (if required by customer), their throats are cut, and they are allowed to bleed out in slush ice made from potable water. Otherwise, tilapia are killed by placing them into slush ice and then bled out. Fish are immediately processed if possible — within 24 hours as long as fish temperature can remain at 39.2 F/4 C or below. Fish are eviscerated by hand by workers who have been trained in good manufacturing practices, and sanitation and hygiene practices, as per the requirements of 21 CFR Part 117 with their training documented.

Washing: Eviscerated fish are washed in potable water containing a sanitizer (chlorinated well water [2-4 ppm] or other appropriate treatment) to reduce the number of environmental bacteria on the surface of the fish. Fish are weighed (25 pounds +/- 5% allowance) and then layered with clean potable iced water into clean polystyrene boxes that have clean plastic liners. Neither the boxes nor the liners can have signs of damage or contamination. Both the boxes and the liners are from approved suppliers.

Ice: Ice is made from potable well water in a commercial ice maker and is stored in sanitary containers and handled with sanitary utensils. Any ice that is not in immediate use is held in a covered tote with a drain so that water can run out to a floor drain. Any ice transferred to a tote is used within 24 hours.

7

Packaging materials: Packaging materials (plastic liners, polystyrene containers) are inspected for signs of odor, damage, or contamination. Label tape is inspected for logo. Print stock for labeling containers is inspected to see that it meets technical specifications and shows no visible signs of contamination. These materials are part of our supply chain program, and the distributor is visited on an annual basis. Materials come with a letter of guarantee that they are appropriate for food contact and they meet our technical specifications per contract. Packaging materials are stored covered in an area segregated from the food processing or production areas and away from where any allergenic materials or chemicals are stored. Temperatures should not exceed 110 F /44 C.

Weighing, labeling, and shipping – whole fish: Boxes are labeled with lot code, species, production location, address, contact information, and harvest date, and then shipped on ice to the market. Temperature is monitored during shipment with a thermometer, a data logger, or the presence of adequate ice at receiving.

Lettuce ProductionReceive lettuce seeds: Lettuce seeds are received from an approved supplier and germinated in sanitized single-use rockwool starter cubes in potable well water.

Germination and planting on rafts: After germination, the lettuce plants are placed into holes in rafts to receive water and nutrients from the aquaculture section of the operations. Rafts are made from polystyrene and are cleaned and sanitized after every use.

Plant nutrients: Supplemental liquid nutrient mix is purchased from an approved supplier who provides a certificate of analysis annually. These nutrients are added in cases where nutrients in the water from the aquaculture tanks are not sufficient, and signs of nutrient deficiency are present. Plant nutrients are transferred to the growing tanks using a metering pump with clean and sanitized tubing. Plant nutrients are stored in a secured area away from cultivation and processing operations.

All handling of plants in the produce production area are conducted by workers who maintain the best personal hygiene practices. Workers wear clean uniforms and head covers and use disposable gloves to reduce the risk of cross-contamination. They are trained as required under 21 CFR Parts 112 and 117, with their training documented. Worker refresher training is

provided at least annually; training for seasonal workers is provided at the beginning of the season or anytime when a deficiency is noted. Biosecurity measures are maintained in the growing area by use of hand and foot dips containing sanitizer. Farm animals, specifically dogs, are kept out of the produce production areas.

UV or ozone unit – plant production: Water is passed through a UV unit or ozonated after use in the fish rearing tanks and prior to irrigating lettuce. Either UV or ozone sanitizes the water and reduces risk of accumulation of pathogenic microorganisms. The water samples are tested every week for total coliforms (<4 CFU/ml) and for presence or absence of Escherichia coli, Listeria monocytogenes, Salmonella spp., and Vibrio spp. The intensity of UV light is checked weekly to determine remaining bulb life following the manufacturer’s instructions. Surface fouling of the UV system is monitored daily, and fouling is removed as needed. Ozone level is checked using a calibrated, dissolved ozone monitor.

Lettuce harvesting: Sanitation during harvesting is critical. All workers wear disposable gloves, hair coverings, sanitizable footwear, and clean uniforms during the harvesting process, and they enter the processing area with sanitized footwear. Workers change into sanitized footwear in the processing room; this footwear is allowed only in the processing room. Any worker in this area has received relevant training under 21 CFR Parts 112 and 117 with training documented. Harvesting is conducted by removing the raft from the water tanks. When removing the rafts, workers must ensure that the water from the bottom of the rafts and the plant roots does not splash in a manner that it could contaminate the edible portion of plants on other racks.

The rafts are transported to the processing area on a clean and sanitized handcart. The roots of the lettuce plants are cut off from the underside of the raft using clean and sanitized knives. Lettuce is then transferred to previously sanitized bins. These bins are transferred to the packing area where the lettuce is rinsed in potable water and drained. This area contains a stainless steel sink with hot and cold potable water, a stainless steel drainage table, and a packing table. A separate hand-wash sink with hand sanitizer is available in this processing area. The water source is well water that has been sanitized (chlorinated [2-4 ppm]) before being used to wash the lettuce. Foot dips containing sanitizer are at the entrance, and hand dips are located in the harvest area.

8

Dewatering and draining: Lettuce is placed on a clean and sanitary stainless steel table for draining.

Size sorting and trimming: The washed lettuce is sorted based on size, and rejected produce that does not meet quality standards is discarded, or it is collected, segregated in a separate bin, and sent to a local farm for use as animal feed.

Ice: Ice is made from potable well water in a commercial ice maker and is stored in sanitary containers and handled with sanitary utensils. Any ice that is not in immediate use is held in a covered tote with a drain so that water can run out of the container to a floor drain. Any ice transferred to a tote or smaller container is to be used within 24 hours, after which it is discarded.

Packaging materials: Packaging materials (plastic clam shells, fiberboard boxes, polyethylene liners, adhesive seals, logo sealing tape) are inspected for signs of damage or physical contamination. These materials are part of our supply chain program, and the distributor is visited on an annual basis. Materials come with a letter of guarantee that they are appropriate for food contact and they meet our technical specifications as per the contract. Packaging materials are stored covered in an area segregated from the food processing or production areas and away from any allergenic materials, dust, moisture, or chemicals. Temperatures should not to exceed 110 F/44 C.

Metal and physical objects inspection: After sorting, lettuce is visually inspected by workers for the presence of foreign matter, including raft or rockwool residue.

Packing: Lettuce is packed in plastic clamshells and labeled with the common name of the produce, production date and location, lot code, best-by date, storage and use instructions, and allergen warning (produced in an aquaponics facility that also produces tilapia). Clamshells are sealed with a tamper-evident adhesive seal. For wholesale distribution, fiberboard boxes are lined with a gas-permeable polyethylene case liner and filled with 24 count per carton. The lot code is applied, and the carton is sealed with company logo tape.

Cold storage: The products are stored in a cold room (34-36 F/1.5-3.0 C) until transferred to the market that is to occur within two days.

Shipping: Lettuce is shipped refrigerated to the market by common carrier. First in, first out (FIFO) rules will apply to distribution. The vehicle used for shipment is evaluated so that it meets the requirements for sanitary transport (21 CFR Parts 1 and 11).

Note: The fish and plant production are physically separated so the fish are not in contact with the plants for biosecurity and allergen control. In addition, the fish processing and packing room is a separate room from the lettuce processing and packing room to reduce the risk of cross-contamination. Individuals are not to move between the two areas unless they follow the sanitation, phytosanitary, and biosecurity procedures in place to reduce cross-contamination.

Note: The facility has restrooms located on the farm and in each processing room. They are equipped with hand-washing sinks, sanitizers, and disposable paper towels, which meets the requirements of 21 CFR Parts 117 and 123.

Hazard Analysis

Fish Culturing

Fish Culturing in Coupled SystemTable 4. Food safety plan for fish culturing in a coupled aquaponic system. (See page 10)

Fish Culturing in Decoupled SystemTable 5. Food safety plan for fish culturing in a decoupled aquaponic system. (See page 15)

Fish Processing

Live FishTable 6. Food safety plan for live fish processing. (See page 20)

Whole FishTable 7. Food safety plan for whole fish processing. (See page 25)

Plant Processing

Lettuce CultivationTable 8. Food safety plan for lettuce cultivation. (See page 31)

9

Lettuce ProcessingTable 9. Food safety plan for lettuce processing. (See page 38)

Food Safety Plan: Process Preventive Controls

Fish Culturing

Fish Culturing in Coupled SystemTable 10. Food safety plan: Process preventive controls for fish culturing in coupled aquaponics system. (See page 44)

Fish Culturing in Decoupled SystemTable 11. Food safety plan: Process preventive controls for fish culturing in decoupled aquaponics system. (See page 48)

Fish Processing

Live FishTable 12. Food safety plan: Process preventive controls for live fish processing. (See page 51)

Whole Fish, Bled and EvisceratedTable 13. Food safety plan: Process preventive controls for whole fish processing. (See page 55)

Lettuce Cultivation Table 14. Food safety plan: Process preventive control for lettuce cultivation. (See page 56)

Lettuce ProcessingTable 15. Food safety plan: Process preventive control for lettuce processing. (See page 59)

Food Safety Plan: Allergen Pre-ventive Controls

Fish ProductsTable 16. Food safety plan: Allergen preventive controls for fish products. (See page 60)

Table 17. Fish product labeling. (See page 61)

Scheduling implications: Special production scheduling not necessary as all finished products contain the fish allergen.

Allergen cleaning implications: No special sanitation controls required specific to the fish allergens as all finished product contains the fish allergen.

Lettuce ProductTable 18. Food safety plan: Allergen preventive controls for lettuce. (See page 62)

Table 19. Lettuce product labeling. (See page 63)

Scheduling implications: Special production scheduling not necessary as all finished products contain or could come into contact with the fish allergen.

Allergen cleaning implications: No special sanitation controls required specific to the fish allergens as all finished product contains or could come into contact with the fish allergen.

Food Safety Plan: Sanitation Preventive Controls

Sanitation Preventive Controls: Facility Sanitation Monitoring Master ListTable 20. Sanitation preventive controls: Facility sanitation monitoring master list. (See page 64)

Sanitation Preventive Controls: Facility Sanitation Verification ActivitiesTable 21. Sanitation preventive controls: Facility sanitation verification activities. (See page 64)

Sanitation Preventive Controls: Facility Sanitation Implementation/ EffectivenessTable 22. Sanitation preventive controls: Facility sanitation implementation/effectiveness. (See page 65)

Food Safety Plan: General Assessment Information

Assessment – Food Protection Table 23. Food protection plan. (See page 66)

10

(1) Ingredient/ processing

step

(2) Identify potential food safety hazards intro-duced, controlled, or

enhanced

(3) Do any

potential food safe-ty hazards require a

preventive control?

(4)Justify your decision for

column 3

(5)What preventive con-

trol measure(s) can be applied to significantly

minimize or prevent the food safety haz-

ard? Processes include CCPs, allergens, sanita-tion, supply chain, other

preventive controls

(6) Is pre-ventive control

applied at this step?

Yes No Yes No

Receiving fish finger-lings

B Biological hazard: microbial contami-nation such asL. monocytogenes,Aeromonas hydrophila

X History of out-break

Supply chain control, ap-proved supplier third-party auditMicrobial testing of fish as part of health certificate sent with each lot of fish

X

C Chemical hazard: antibiotics

X Unapproved antibiotics un-likely for fish

X

P Physical hazard: foreign materials

X Unlikely for fish fingerlings

X

A Allergen contami-nation

X No allergens introduced be-sides fish itself

X

E Economic fraud: wrong species

X Fresh water fish are not hista-mine-forming species; biotox-in risk is low

X

I Intentional con-tamination

X Risk low because like-ly toxicants would affect fish health or behavior

Supply chain control pro-gram

X

Table 4. Food safety plan for fish culturing in a coupled aquaponic system.

Food Safety Plan – Hazard Analysis Coupled Aquaponics System

Aquaponic tilapia – Blue tilapia (Tilapia aurea) and hydroponic lettuce in a coupled system

Green Aquaponics LLC, 456 River Way, Aquatown, WA 98765Approved by: P. GreenSignature: P. Green Peter Green, Processing Manager



11


step


enhanced

(3) Do any


preventive control?


column 3





preventive controls



Yes No Yes No

Introducing fingerlings to tank

B Biological hazard: microbial contam-ination

X Fish from bios-ecure area and not released unless cleared for stocking by animal health professional

Biosecurity program X

C Chemical hazard: animal drugs or unapproved chem-icals

X Fish from bios-ecure area and not released unless cleared for stocking by animal health professional



X Easily removed if present

X


X No allergens introduced

X

E Economic fraud X Species substi-tution

Species identification verified when fingerlings received

X


X Fish transferred under moni-tored condi-tions, making risk low

X

Fish culturing or grow out

B Biological hazard: microbial contami-nation and growth: A. hydrophila,L. monocytogenes,Vibrio spp.,Salmonella spp.,Pathogenic E. coli


Sampling and providing tests results from third-party labSampling from water, fish, and feedWater meets specifications required under Part 112Pest control programPersonnel hygiene training programRestrict access of warm-blooded animals to the farm

X

Table 4. Food safety plan for fish culturing in a coupled aquaponic system. (cont.)

12


step


enhanced

(3) Do any


preventive control?


column 3





preventive controls



Yes No Yes No


X Possibility of harmful residues in fish flesh

Antibiotics are used under proper supervision and only in fish removed from productionFish are not to be fed ther-apeutic feeds in production tanks

X

P Physical hazard: debris

X Debris would settle in tank

X



X

E Economic fraud X XI Intentional con-

taminationX Contamination

of feed or waterFeed is stored in locked storage area with controlled accessWater source is monitored and access controlled; 24-hr video surveillance

X

Solids remov-al filters

B Biological hazard: bacterial contami-nation and growth

X Wet, solid materials are a source of nutri-ents for envi-ronmental bac-teria, including pathogens

Correct management of filter operation and Good Manufacturing Practices (GMPs); collecting and removing solids from the system critical for fish quality

X

C Chemical hazard X No chemical addition at this step

X

P Physical hazard X Physical haz-ards removed at this step

X

A Allergens contam-ination

X No allergens introduced from filter operation

X

E Economic fraud X Low risk of a hazard that would affect food

X

I Intentional adulter-ation

X At a discharge point; low risk

X


13


step


enhanced

(3) Do any


preventive control?


column 3





preventive controls



Yes No Yes NoBiofilters B Biological hazard:

microbial contam-ination

X Contamination in biofilters possible

GMPs control spurious microbial growth

X

C Chemical hazard: contamination

X Ammonia lev-els highIf biofilters do not work appropriately, the ammonia level increases and could be harmful to fish

Collect samples from bio-filters to measure ammonia, nitrite, and nitrate as part of GMPsA fish health factor but not a food safety risk

X


X Biofilter should not be clogged

Regular checking of the biofilter to remove any solid materials

X



X

E Economic fraud X Low risk for a food safety hazard

X


X Enclosed and difficult to contaminate

X

UV or ozonated discharge to hydroponic unit

B Biological hazard: microbial contami-nation and growth

X UV system verified by manufacturer and operated according to their instruc-tions; system has been val-idated on-site for microbial controlIf ozone used, concentrations are monitored and controlled to standards for irrigation water under Part 112

Daily check on operation of UV system for fouling, and weekly monitoring of light intensityMonitoring of ozone con-centration

X


14


step


enhanced

(3) Do any


preventive control?


column 3





preventive controls



Yes No Yes No

UV or ozonated discharge to hydroponic unit (cont.)


X No chemicals used at this step

GMPs X


X Unlikely Settled out or removed by filters

X



GMPs control water distri-bution systemNo cross-connections

X

E Economic fraud X Low-quality system func-tionality easily detected; does not pose direct food safety threat

X


X X

Purging fish – transfer fish to purge tanks


X Potable water used

Routine water testing pro-gram in place

X


X Potable water used


X

P Physical hazard: foreign material

X Visual detection and re-moval

X



Fish are not fed during purging or transfer

X

E Economic fraud X X

I Intentional con-tamination: access to fish

X Fish are held in secured area

Control access to approved individuals only

X


15

Table 5. Food safety plan for fish culturing in a decoupled aquaponic system.

Food Safety Plan – Hazard Analysis Decoupled Aquaponics System

Aquaponic tilapia – Blue tilapia (Tilapia aurea) and hydroponic lettuce in decoupled system

Green Aquaponics LLC, 456 River Way, Aqua-town, WA 98765





step


enhanced

(3) Do any


preventive control?


column 3



minimize or prevent the food safety hazard?

Processes include CCPs, allergens, sanitation,

supply chain, other pre-ventive controls



Yes No Yes No

Receiving fish finger-lings

B Biological hazard: microbial contami-nation such as L. monocytogenes,A. hydrophila


Supply chain control, ap-proved supplier, third-party audit

X


X Unapproved antibiotics un-likely for fish

X


X Unlikely for fish fingerling

X



X

E Economic fraud X Wrong speciesFresh water fish are not hista-mine-forming species; biotox-in risk is low

Supply chain control, ap-proved supplier, third-party audit

X

I Intentional contam-ination

X Low risk because likely toxicants would affect fish health or behavior


X

16


step


enhanced

(3) Do any


preventive control?


column 3








Yes No Yes No

Introducing fingerlings to tank

B Biological hazard: microbial contami-nation

X Fish are from biosecure area and not released unless cleared for stocking by animal health professional


C Chemical hazard: animal drugs or un-approved chemicals

X Fish are from biosecure area and not released unless cleared for stocking by animal health professional



X Easily removed if present

X


X No unique allergens intro-duced

X

E Economic fraud X Species identifi-cation verified

X


X Fish transferred under moni-tored condi-tions, making risk low

X


X Contamination of feed or water

Feed is stored in locked storage area with controlled accessWater source is monitored and access controlled 24-hr video surveillance

X

Solids remov-al filters

B Biological hazard: bacterial contami-nation and growth

X Wet, solid materials are a source of nutrients for environmental bacteria, includ-ing pathogens

Correct management of fil-tration system and GMPs; collecting and removing solids from the system is critical for fish health and product quality

X

Table 5. Food safety plan for fish culturing in a decoupled aquaponic system. (cont.)

17


step


enhanced

(3) Do any


preventive control?


column 3








Yes No Yes No

Solids re-moval filters (cont.)

C Chemical hazard X No chemicals added

X

P Physical hazard X Debris would be removed at this step

X

A Allergen contamination


X

E Economic fraud X X

I Intentional adulteration

X X

Biofilters B Biological hazard: microbial contami-nation and growth

X Microbial contamination with pathogens possible

GMPs control growth of spurious microorganisms; if filter is contaminated, it is taken off-line

X

C Chemical hazard: ammonia

X If biofilters do not work appropriately, the ammonia level increases and could be harmful to fish; could lead to the proliferation of harmful mi-crobes

Collecting samples from biofilters to measure am-monia, nitrite, and nitrate as part of GMPs. This is primarily a fish health and product quality issue

X

P Physical hazard: solid materials

X Biofilter should not be clogged. Filter would remove some foreign material

Regular checking of the biofilter to remove any solid materials

X



X

E Economic fraud X Would not pose a food safety risk

X


X Unlikely in a closed system

Operation of biofilters would likely be impact-ed quickly if toxins were introduced

X


18


step


enhanced

(3) Do any


preventive control?


column 3








Yes No Yes No

UV or ozonated discharge to hydroponic unit


X UV or ozone systems installed to re-duce microbes to target levels, (i.e., to agri-cultural water standards)

Daily check on operation of UV system for fouling, and weekly monitoring of light intensity

Monitor concentration of ozone in water

X

C Chemical hazard X No chemicals introduced

X

P Physical hazard X No debris intro-duced

X



X

E Economic fraud X Low-quality system function-ality easily de-tected; does not pose direct food safety threat

Daily and weekly checks for light intensity and ozone levels

X


X UV and ozone generators are closed systems

X

Purging fish – transfer fish to purge tanks


X Treated or pota-ble water used


X

C Chemical hazard X No chemicals introduced

X

P Physical hazard X Debris, if any, removed at later steps

X



X

E Economic fraud X Step is to eliminate gut contents and improve flesh quality

X


19


step


enhanced

(3) Do any


preventive control?


column 3








Yes No Yes No

Purging fish – transfer fish to purge tanks (cont.)

I Intentional contam-ination: access to fish

X Fish are held in secured areaControlled access for ap-proved individ-uals only

X


20

Table 6. Food safety plan for live fish processing.

Food Safety Plan – Hazard Analysis Decoupled Aquaponics Systems

Aquaponic tilapia – Blue tilapia (Tilapia aurea) and hydroponic lettuce

Green Aquaponics LLC, 456 River Way, Aqua-town, WA 98765Approved by: P. GreenSignature: P. Green Peter Green, Processing Manager




step


enhanced

(3) Do any


preventive control?


column 3








Yes No Yes No

Gas (oxygen or air)

B Biological hazard X Contamination of pressurized gas unlikely

X

C Chemical hazard X Gas is food-grade Contamination of pressurized gas unlikely

Supply chain controls, cer-tificate of analysis

X

P Physical hazard X Gas is filtered X


X No unique aller-gens introduced

X

E Economic fraud X Gas substitution unlikely

X


X Pressurized cyl-inders are closed and secured

X

Tanks B Biological hazard: microbial contami-nation and growth

X Live hauls are short; tempera-ture kept cool

GMPs X

C Chemical hazard: chemical contami-nation

X Fish are trans-ferred in clean water; no chem-icals are added except infused gas

X

21

Table 6. Food safety plan for live fish processing. (cont.)


step


enhanced

(3) Do any


preventive control?


column 3








Yes No Yes No

Tanks (cont.) P Physical hazard X Physical hazards would settle out in tank

X



X

E Economic fraud X Transportation step for fish of known species

X


X Tanks are sealed with a numbered seal. Access during transit unlikely

Receive fish for process-ing from purge tanks

B Biological hazard: microbial contam-ination and growth such as L. monocytogenes,E. coli,Salmonella


Sampling and third-party microbial analysis from fish meat and waterProper fish handling and minimized cross-contami-nation

X

C Chemical hazard:antibiotics, pesticide

X Unapproved chemical use

For pest control, no chem-icals should be used inside facility; biological pest control should be appliedNo animal drugs used in fish production

X


X Unlikely Unlikely to have foreign objects in fish, but would be visually apparent and then removed

A Tilapia fish allergen X X

22


step


enhanced

(3) Do any


preventive control?


column 3








Yes No Yes No

Receive fish for process-ing from purge tanks (cont.)

E Species substitution X Fish species controlled within facility at receiving step; only fish cultured at the facility are processed at this facility

X


X Tanks are secured

Internal inventory control and monitoring, including video surveillanceReduce risk for contamina-tion of water used by secur-ing source and controlling access

X

Weigh using load cell in net; transfer fish to live tank for ship-ment


X Process is short and conducted under refriger-ated conditions

Refrigeration and sanitation SOPs maintained

X

C Chemical hazard: unapproved chem-icals

X Only approved chemicals used for cleaning and sanitizing

Sanitation SOPs maintained X


X Easily removed X



X

E Economic fraud: fish are inaccurately weighed

X Unlikely, and would not pose a food safety threat

Load cell is calibrated and operators properly trained to take and record weights

X


X Transfer step with minimal handling

X

Label B Biological hazard: microbial contami-nation

X Fish are han-dled at this step and could become con-taminated

Sanitation and GMP programs to reduce risk of contamination, and short shipment

X


23


step


enhanced

(3) Do any


preventive control?


column 3








Yes No Yes No

Label (cont.) C Chemical hazard: allergens

X Fish contain allergens

Labeled as containing fish allergens and with species name

X

P Physical hazard Any foreign material that might be harmful would be visible and easily removed

Visual inspection X

A Tilapia fish allergen X Fish allergen labeling is required

Allergen labeling statement needed

X

E Species and net weight

X Proper species ID and net weight on pack-age

GMPs and technical speci-fications followed

X


X Tamper-evident feature on live tanks (unique seal) and lot code for traceability in case of a recall

X

Ship B Biological hazard: microbial growth

X Temperature control needed by monitoring ice level

Short shipment; fish on adequate amount of ice maintained, and ice level and fish temperature at cus-tomer receipt documented

X


X Live tank sealed; any ox-ygen or air used is food-grade

Tank integrity ensured

Food-grade gas use moni-tored by GMPs

X


X Live tank sealed, so contamination unlikely

Visual inspection X

A Allergen contami-nation: tilapia fish allergen

X Container sealed

Allergen labeling state-ment, fish species, and common name on shipping container

X


24


step


enhanced

(3) Do any


preventive control?


column 3








Yes No Yes No

Ship (cont.) E Economic fraud: species ID and net weight

X Container sealed

Proper species ID and net weight on packages

X


X Tamper-evident feature on tank (unique seal) and lot code for traceability in case of a recallPackage integrity main-tained during shipment; shipment rejected if seal missing, number incorrect, or package damaged

X


25


step


enhanced

(3) Do any

potential food safe-ty hazards

require a pre-

ventive control?


column 3


trol measure(s) can be applied to significantly minimize or prevent the food safety hazard? Pro-

cesses include CCPs, allergens, sanitation,




Yes No Yes No

Packaging B Biological hazard X Packaging has a heat step during manufacture; no recycled paper is used

Physical inspection on receipt

X


X Packaging must be food-grade

Supply chain control pro-gram; letter of guarantee

X

P Physical hazard X Debris, foreign matter

GMP; physical inspection on receipt

X


X No allergenic materials used


X

E Economic fraud X Safety issue not likely to result from inferior materials


X


X Materials are in sealed contain-ers

Sealed packaging stored in secure location

X

Ice B Biological hazard: microbial contami-nation

X Microbially contaminated water

GMP; use only tested potable water that meets drinking water standards

X


X Chemically contaminated water

GMP; use only tested potable water that meets drinking water standards

X

Table 7. Food safety plan for whole fish processing.

Food Safety Plan – Hazard Analysis Decoupled Aquaponics Systems


Green Aquaponics LLC, 456 River Way, Aquatown, WA 98765Approved by: P. GreenSignature: P. Green Peter Green, Processing Manager



26


step


enhanced

(3) Do any


require a pre-

ventive control?


column 3







Yes No Yes No

Ice (cont.) P Physical hazard: foreign material

X Physical debris GMP; debris would be detected visually and removed; if small metallic debris, would be rinsed off during process or removed by filtration

X


X Not likely to be present in well water

X

E Economic fraud X Water from secured private well

X


X Water from secured private well

X

Receive fish from purge tank for pro-cessing

B Contamination withL. monocytogenes,E. coli,Salmonella spp.Microbial growth

X History of out-breakProcessing temperature (50 F or less) will reduce risk of microbial growth

Sampling and third-party microbial analysis from fish meat and waterProper fish handling and minimized cross-contami-nation. Verify proper processing environment temperature

X

C Antibiotics, Pesticides

X No unapproved chemical use

No antibiotics or animal drugs usedFor pest control, no chem-icals should be used inside facility; biological pest control should be applied

X

P Foreign materials X Unlikely Visual inspection and removal

X

A Tilapia fish allergen X No unique aller-gen introduced at this step

No unique allergen intro-duced at this step

X

E Species substitution X Unlikely because only one species processed at facility

Fish species controlled within facility at receiving step; only fish cultured here are processed at this facility

X

Table 7. Food safety plan for whole fish processing. (cont.)

27


step


enhanced

(3) Do any


require a pre-

ventive control?


column 3







Yes No Yes No

Receive fish from purge tank for processing (cont.)


X Unlikely; step monitored and access con-trolled

Internal inventory control and monitoring, including video surveillance

X

Bleed and eviscerate

B Microbial contami-nation and growth

X Processed under sanitary condi-tions and with potable water

Sanitary conditions are maintained; fish at cold temperature; viscera promptly separated from fish and disposed of

X

C Chemical contami-nation

X Unlikely; only potable water used at this step

No unapproved chemicals are used in facilityWater is potable

X

P Foreign material X Unlikely; fish have already been washed to remove any debris in next processing step

Would be visible and easily removed

X

A Allergen X No unique aller-gens introduced at this step

X

E Economic fraud X Unlikely to pose food safety hazard; trained individ uals per-form this step

Technical specifications on grading and cuts are met

X


X Unlikely; pro-cess is moni-tored

Operation monitored; later steps would remove con-tamination

X

Washing B Microbial contami-nation:E. coli,L. monocytogenes


Sanitizing the water with chlorine or other approved sanitizer; daily water sam-pling and testing for chlo-rine or other sanitizer as part of sanitation program

X

C Chemical contami-nation

X No unapproved chemicals used

Water is filtered and potable X


28


step


enhanced

(3) Do any


require a pre-

ventive control?


column 3







Yes No Yes No

Washing (cont.)

P Foreign material X Filtered, potable water used

Water is filtered and potable X

A Tilapia fish allergen X No unique aller-gens introduced at this step

No unique allergens present in processing facility

X

E N/A X X


X Reduce risk for contamina-tion of water used

X

Weighing, pack, ice, label


X Fish are han-dled by people at this stepIce could be contaminatedBins or pack-aging could be contaminated

Sanitation and GMP programs to reduce risk of contamination

X


X No chemicals used at this step

Appropriate GMPs X


X Any foreign material that might be harmful would be visible and easily removed

X


X Fish is a recog-nized allergen

Fish are allergens and should be labeled as aller-gensSpecies and common names on packageAllergen labeling statement

X

E Economic fraud: species and net weight

X Proper species ID and net weight must be on package Cultivated fresh water fish pose little safety risk from species substi tution

GMPs and technical speci-fications followedOnly one species grown in facility

X


29


step


enhanced

(3) Do any


require a pre-

ventive control?


column 3







Yes No Yes No

Weighing, pack, ice, label (cont.)


X Tamper-evident feature on package (unique sealing tape) and lot code for trace-ability in case of a recall

X

Store on ice B Biological hazard -microbial growth

X Ice could be contaminated

Potable water and clean totes used; sanitation Stan-dard Sanitation Operating Procedures (SSOPs)FIFO stock rotation and temperature monitoring

X


X Ice could be contaminated

Potable water and clean totes used

X


X Debris could be present in ice

Ice made from potable wa-ter and held under sanitary conditionsAny debris would be visi-ble and could be removed

X


X Allergen intro-duction unlikely

Container is sealed X

E Economic fraud X Species misla-beled

Only one type of fish grown in facility

X


X Contaminated ice

Ice kept in secure area with controlled access

X

Ship B Biological hazard: microbial growth

X Temperature control needed by monitoring ice level

Short shipment; fish on adequate amount of ice

X


X Container sealed

Package integrity ensured X


X Container sealed

Visual inspection X


X Container sealed

Readable and prominent allergen labeling statement; fish species and common names on shipping con-tainer

X


30


step


enhanced

(3) Do any


require a pre-

ventive control?


column 3







Yes No Yes No

Ship (cont.) E Economic fraud X Container sealed

Proper species ID and net weight on package

X


X Tamper-evident feature on package (unique seal) and lot code for traceability in case of a recallPackage integrity ensured during shipment

X


31


step


enhanced

(3) Do any

potential food safety

hazards require a

preventive control?


column 3

(5)What preventive control measure(s) can be ap-

plied to significantly min-imize or prevent the food safety hazard? Process-es include CCPs, aller-

gens, sanitation, supply chain, other preventive

controls



Yes No Yes No

Packaging B Biological hazard: microbial contami-nation

X Packaging has low risk of contamination during manu-facture and is inspected on receipt for dam-age; no recycled content in boxes

Physical inspection on receipt for damage and odor; all packaging must be sealed

X


X Packaging must be food-grade

Supply chain control, letter of guarantee

X


X Debris, foreign matter

GMP, physical inspection on receipt; if present, ship-ment rejected

X


X No allergenic materials used in manufacture

Supply chain control program

X

E Economic fraud X Safety issue not likely to result from inferior materials


X


X Materials in sealed contain-ers

Materials stored in secure location with limited access

X

Table 8. Food safety plan for lettuce cultivation.

Food Safety Plan – Hazard AnalysisDecoupled Aquaponics Systems


Green Aquaponics LLC, 456 River Way, Aqua-town, WA 98765Approved by: P. GreenSignature: P. Green Peter Green, Processing Manager



32


step


enhanced

(3) Do any


hazards require a

preventive control?


column 3




controls



Yes No Yes No

Nutrient mixes


X Nutrient mixes are treated to reduce micro-bial load during manufacture by filtration or heating

Supply chain program, cer-tificate of analysis, inspec-tion at receipt

X


X Nutrient mix must be food-grade

Supply chain program, certificate of analysis

X

P Physical hazard: physical

X Liquid material Supply chain programContainers with foreign materials rejected

X


X Formulations not likely to contain aller-gens

Supply chain program, letter of guarantee

X

E Economic fraud X Fraud not likely to cause food safety concern but could affect plant growth

Supply chain program, letter of guarantee

X


X Addition of nutrients into large volume of water poses a risk; disgrun-tled employees

Nutrients stored in secure area with limited accessTight inventory control Use only by trained and trusted employeeFood defense program

X

Ice B Biological hazard: microbial contami-nation

X Microbially contaminated water

GMP, use tested potable water that meets drinking water standards

X


X Chemically contaminated water

GMP, use tested potable water that meets drinking water standards

X

Table 8. Food safety plan for lettuce cultivation. (cont.)

33


step


enhanced

(3) Do any


hazards require a

preventive control?


column 3




controls



Yes No Yes No

Ice (cont.) P Physical hazard: foreign material

X Physical debris GMP, debris would be visu-ally detected and removed; small metallic debris would be rinsed off during pro-cessing or removed by filtration

A Allergen contami-nation-

X Not likely in well water

X

E Economic fraud X Water from secured private well

X


X Water from secured private well

Limited access to well X

Receive lettuce seed

B Biological hazard: microbial contami-nation such asL. monocytogenes,Salmonella spp.E. coli


Supply chain control, ap-proved supplier third-party audit

X

C Chemical hazard: pesticide residues

X Unapproved pesticides not used. Seed from approved suppliersPeriodic analy-sis for verifica-tionLetter of guar-antee

X


X Unlikely Foreign materials do not cause any food safety con-cern when seeds are used for germination and not eaten as is

X


X Fish and lettuce production physically seg-regated

GMPs X


34


step


enhanced

(3) Do any


hazards require a

preventive control?


column 3




controls



Yes No Yes No

Receive lettuce seed (cont.)

E Economic fraud X Lettuce seed purchased from approved supplier


X


X Seeds from ap-proved supplier who is inspect-ed and audited annually


X

Germination of seeds on rafts


X Pathogens and spoilage microbes could grow on rafts, plants, or in water

Monitor water quality in GMPsObserve for presence of microbial growth or plant disease

X


X Unapproved chemical use

Maintain proper GMPs (water chemistry) and sani-tation SOPs

X


X Debris from rafts or tanks

Any debris would sink or be easily removed

X

A Allergen contam-ination: allergen introduction

X No unique allergens added at this stepGermination media, seeds, and nutrients are aller-gen-free

Fish and lettuce cultivation operations are physically segregated

X

E Economic fraud X Not likely that substitution of seeds nutrients would pose a food safety risk

Letters of guarantee, supply chain program

X


35


step


enhanced

(3) Do any


hazards require a

preventive control?


column 3




controls



Yes No Yes No

Germination of seeds on rafts (cont.)


X Germination system contam-inated

System closely monitored; biosecurity maintained

X

Lettuce grow out on rafts


X Water, nutri-ents, and plant tissue can sup-port microbial growth

Water is sanitized prior to use with UV light or ozone

Facility is kept clean and sanitary

Operators look for signs of disease

X


X Cultivation conditions are carefully con-trolledWater chemis-try monitored

GMPs X


X Any debris would be re-moved at a later step

GMPs X


X Fish and lettuce production physically segregated; no containers or utensils are transferred be-tween fish and lettuce produc-tion areas

GMPs X

E Economic fraud X Not likely to occur; not like-ly to pose food safety hazard

X


36


step


enhanced

(3) Do any


hazards require a

preventive control?


column 3




controls



Yes No Yes No

Lettuce grow out on rafts (cont.)

I Intentional adulter-ation: contaminants introduced into water system

X Cultivation conditions are carefully controlled and monitored

24-hr video surveillance X

Lettuce harvesting

B Biological hazard: mi-crobial contamination such asL. monocytogenes, E. coli, Salmonella spp.,Vibrio spp.


Use previously sanitized harvesting tools and gloves, and proper hand-washing practices to prevent any cross-contaminationTrained workers employ best hygiene practices

X

C Chemical hazard: pesticide residues

X GMPs make pesticide use unlikely

Pesticides should not be used in aquaponic systems and are banned from this facility

X

P Physical hazard: raft residue, metal fragments

X Possible metal and raft residue into the lettuce

Metal detection by visu-ally checking lettuce and removing any metal and residue during harvesting; later rinse step to remove debris

X

A Allergen contam-ination: allergen transfer

X Harvest condi-tions are care-fully controlled

GMPsFish and plant operations physically segregatedWorkers from aquaponics section not permitted to handle lettuce unless they follow sanitation and aller-gen control procedures

X

E Economic fraud X Not likely; no food safety haz-ard anticipated

X


37


step


enhanced

(3) Do any


hazards require a

preventive control?


column 3




controls



Yes No Yes No

Lettuce harvesting (cont.)


X Harvest condi-tions are care-fully controlled and monitored

No individuals work alone in harvesting and production areas24-hr video surveillance. No personal items or chemi-cals are permitted in harvest area

X

Cut lettuce from raft and place into bin


X Drip from plants could contain mi-crobes; bins could be con-taminated

GMPs have lettuce plants not draining onto each otherBins and utensils are cleaned, sanitized, and stored off the ground

X


X No chemicals used in process

GMPs in place to control hazard

X

P Physical hazard: for-eign material

X Any introduced debris would be large enough to visually remove

GMPs in place to control hazard

X

A Allergen contam-ination: allergen transfer

X Harvest condi-tions are care-fully controlled

GMPsFish and plant operations physically segregatedWorkers trained in sanita-tion and allergen control procedures

X

E Economic fraud X Nothing at this step likely to create a food safety hazard

X


X Harvest condi-tions are care-fully controlled and monitored

No individuals work alone in harvesting and produc-tion areas24-hr video surveillanceNo personal items or chem-icals permitted in harvest area

X


38

Table 9. Food safety plan for lettuce processing.

Food Safety Plan – Hazard AnalysisDecoupled Aquaponics Systems


Green Aquaponics LLC, 456 River Way, Aqua-town, WA 98765





step

(2) Identify potential

food safety hazards introduced, con-

trolled, or enhanced

(3) Do any


hazards require a

preventive control? (4)

Justify your decision for

column 3




ard? Processes include CCPs, allergens, san-itation, supply chain, other preventive con-

trols

(6) Is pre-ventive control applied at this step?

Yes No Yes No

Receive lettuce into processing area

B Biological hazard: mi-crobial contamination:L. monocytogenes,E. coli,Salmonella spp.

X History of outbreak

Maintain good hygiene in facility. Workers trained in hygiene practices and activities monitoredMicrobial analysis from lettuce and waterAppropriate separation be-tween fish and lettuce pro-duction units to reduce risk of microbial contamination and ensure biosecurity

X


X Only ap-proved chem-icals used in facility; these are properly handled by trained em-ployeesChemicals are not stored in processing area

GMPs and sanitation con-trol program

X

39


step




(3) Do any


hazards require a



column 3





trols


Yes No Yes No

Receive lettuce into processing area (cont.)


X During planting and growing lettuce, there is a possibility of transferring metal and raft materials to the lettuceVisual exams and rinsing provide controls

X


X No allergen introduction likely at this stepProcessing conditions are carefully controlled and monitored

GMPs. Fish and plant op-erations physically segre-gated

X

E Economic fraud X Nothing at this step likely to pose a food safety hazard

X


X Processing conditions are carefully controlled and monitored

No individuals work alone in production area24-hr video surveillance

X

Sort and grade


X Processing conditions and worker hygiene are carefully controlled and monitored

Sanitation and GMPs X


X Chemicals not used at this step

Sanitation and GMPs X

Table 9. Food safety plan for lettuce processing. (cont.)

40


step




(3) Do any


hazards require a



column 3





trols


Yes No Yes No

Sort and grade (cont.)


X Unlikely Visual inspection for any foreign materials

X


X No unique allergens at this step

GMPs X

E Economic fraud X Nothing at this step likely to pose a food safety hazard

X


X Processing conditions carefully controlled and monitored

GMPs X

Washing and draining

B Biological hazard: microbial contami-nation:L monocytogenes,E. coli,Salmonella spp.

X History of outbreak

Use sanitizer in wash water. Proper sanitizing of wash-ing and draining areaSwab for environmental bacteria as part of verifica-tion program

X

C Chemical hazard: improper sanitizer use

X Correct sanitizers are used at proper concentration

SSOPs, records, and em-ployee training in proper use of sanitizers

X

P Physical hazard: debris

X Particles are visible and can be removed

GMPs X


X Processing conditions are carefully controlled and monitored, so introduction unlikely

GMPs X


41


step




(3) Do any


hazards require a



column 3





trols


Yes No Yes NoWashing and draining (cont.)

E Economic fraud X Nothing likely at this step to pose a food safety hazard

X

I Intentional adulter-ation: contaminated water


GMPs X

Metal and foreign mate-rials inspec-tion


X Short process under sanitary conditions

SSOPs X


X Sanitizer chemicals used at this step are con-trolled

SSOPs X

P Physical hazard: metals and debris

X Visually check the lettuce X


X No additives at this step

GMPs X

E Economic fraud X Nothing likely at this step to pose a food safety hazard

X



X

Packaging and labeling


X Sanitation controls

SSOPs X


X Low risk of contamination

SSOPs and GMPs X


42


step




(3) Do any


hazards require a



column 3





trols


Yes No Yes No

Packaging and labeling (cont.)

P Physical hazard: introduction of foreign material

X Low risk of introduction; could be seen and removed

GMPs X

A Allergen contamina-tion: warning label

X Allergen warning label recommendedLabel lettuce as produced in a facility that also processes fish (tilapia)

GMPs for labeling X

E Economic fraud X Product is properly labeled

X


Label indicating what the tamper-evident feature of package isTamper-evident feature presentLot code for traceability in case of recall

X

Cold storage B Biological hazard: environmental pathogen contami-nation and growth

X Package sealed; low risk of micro-bial contami-nation

Packages kept refrigerated

GMPsShort shelf lifeRefrigeration will reduce rate of microbial growth

X


X No chemicals used

GMPs X


Package sealed

GMPs X


43


step




(3) Do any


hazards require a



column 3





trols


Yes No Yes No

Cold storage (cont.)


Package sealedProduct has proper allergen label applied

GMPs X

E Economic fraud X Package sealed

X


Package sealed

Shipping B Biological hazard: microbial growth

X Refrigerated shipping as needed

Product refrigerated or on iceTemperature controlled

X


X Package sealed

X

P Physical hazard: Foreign materials

X Package sealed

X


X Package sealed

X

E Economic fraud X Package sealed

X


X Package sealed

X


44

Tabl

e 10

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r fish

cul

turin

g in

cou

pled

aqu

apon

ics

syst

em.

Food

Saf

ety

Plan

– P

roce

ss P

reve

ntiv

e C

ontr

ols

Aqua

poni

c til

apia

– B

lue

tilap

ia (T

ilapi

a au

rea)

and

hyd

ropo

nic

lettu

ce –

C

oupl

ed s

yste

ms

Gre

en A

quap

onic

s LL

C, 4

56 R

iver

Way

, Aqu

atow

n, W

A 98

765

Appr

oved

by:

P. G

reen

Si

gnat

ure:

P. G

reen

Pe

ter G

reen

, Pro

cess

ing

Man

ager

Vers

ion

2: S

ept.

9, 2

018

Supe

rced

es: V

ersi

on 1

: Aug

. 1, 2

017

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

FISH

CU

LTU

RIN

G: C

OU

PLED

SY

STEM

Rece

ive

fish

finge

rling

sPa

thog

enic

ba

cter

iaFi

sh a

ppea

r to

be

heal

thy

and

dis-

ease

-free

Each

lot o

f fin

gerli

ngs

has a

hea

lth

certi

ficat

e

Fish

ap

pear

-an

ce a

nd

beha

vior

Pres

ence

of

certi

ficat

e in

dica

ting

path

o-ge

n-fre

e fin

gerli

ngs

Visu

al

insp

ectio

n of

fish

Each

lot

rece

ived

QA

man

ager

Reje

ct lo

t if c

rit-

ical

lim

it is

not

met

,A

ND

disc

ontin

ue u

se

until

supp

lier

agre

es to

pro

vide

ce

rtific

ate

for e

ach

lot

Revi

ew su

pplie

r pr

ogra

m a

nd u

p-da

te a

udit

prog

ram

as

nee

ded

Cond

uct r

oot

caus

e an

alys

is an

d ta

ke a

ctio

n to

pre

-ve

nt re

occu

rrenc

e

Visit

all

new

su

pplie

rs w

ithin

th

e ye

ar a

nd a

ll ex

istin

g su

pplie

rs

at le

ast o

nce

a pe

r ye

ar to

revi

ew th

e gr

ower

’s cu

ltiva

-tio

n fa

cilit

ies a

nd

proc

edur

es a

nd

fish

heal

th p

ro-

gram

Revi

ew c

ertifi

cate

an

d au

dit r

epor

ts an

d re

ceiv

ing

reco

rd

Prod

ucer

’s ce

rtif-

icat

esA

udit

repo

rtsRe

ceiv

ing

reco

rd

show

ing

visu

al

insp

ectio

n of

fish

45

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

FISH

CU

LTU

RIN

G: C

OU

PLED

SY

STEM

Fish

cul

tur-

ing

or g

row

ou

t

Path

ogen

ic

bact

eria

Feed

is

path

o-ge

n-fre

e

Supp

lier

prov

ides

ce

rtific

ate

or re

sults

fro

m

third

-par

ty

lab

show

-in

g fe

ed

is pa

tho-

gen-

free

Visu

al

insp

ectio

n of

feed

an

d fe

ed

reco

rds

Each

lot

QA

man

ager

Reje

ct lo

t of f

eed

if m

icro

bial

load

ou

t of s

pec

Revi

ew su

pply

ch

ain

prog

ram

Prov

ide

appr

opri-

ate

stora

ge fo

r fee

dEv

alua

te p

est

cont

rol s

yste

m to

re

duce

risk

of c

on-

tam

inat

ion

from

pe

stsCo

nduc

t roo

t ca

use

anal

ysis

and

take

act

ion

to p

re-

vent

reoc

curre

nce

Trea

t wat

er to

re

gain

mic

robi

al

cont

rol

Reco

rds r

evie

wRe

view

of f

eed

labe

lPe

riodi

c te

sting

of

feed

for p

atho

gens

(m

onth

ly)

Perio

dic

testi

ng

of fi

sh a

nd w

ater

(m

onth

ly)

Lab

resu

lts fo

r w

ater

Lab

resu

lts fo

r fe

ed

Lab

resu

lts fo

r fish

Path

ogen

ic

bact

eria

Wat

er is

safe

fo

r int

ende

d us

e

Wat

er is

no

t con

-ta

min

ated

Wat

er

treat

men

t sy

stem

fu

nctio

ning

pr

oper

ly

Ope

ratio

n of

wat

er

treat

men

t sy

stem

; vi

sual

, ar

oma,

an

d pH

of

wat

er

Dai

lyQ

A m

anag

erD

iscon

tinue

use

of

cont

amin

ated

feed

an

d re

view

supp

ly

chai

n pr

ogra

mCo

nsid

er n

ew

supp

liers

Cond

uct r

oot

caus

e an

alys

is an

d ta

ke a

ctio

n to

pre

-ve

nt re

occu

rrenc

e

Wee

kly

wat

er te

st-in

g fo

r mic

robe

sRe

cord

s rev

iew

for

wat

er q

ualit

y, c

ali-

brat

ion,

and

mic

ro

lab

resu

lts

Wat

er tr

eatm

ent

syste

m o

pera

tion

reco

rdW

ater

qua

lity

pH, t

empe

ratu

re

reco

rds

Instr

umen

t cal

ibra

-tio

n re

cord

sTe

sting

reco

rds f

or

mon

thly

wel

l tes

t re

sults

Tabl

e 10

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r fish

cul

turin

g in

cou

pled

aqu

apon

ics

syst

em. (

cont

.)

46

Tabl

e 10

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r fish

cul

turin

g in

cou

pled

aqu

apon

ics

syst

em. (

cont

.)

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

FISH

CU

LTU

RIN

G: C

OU

PLED

SY

STEM

Fish

cul

tur-

ing

or g

row

ou

t (co

nt.)

Ant

ibio

tics

or u

nap-

prov

ed

chem

ical

s

Feed

is fr

ee

from

un-

appr

oved

ch

emic

als

Certi

ficat

e sh

owin

g dr

ug-fr

ee

feed

Certi

ficat

e fo

r eac

h lo

tEa

ch lo

tQ

A m

anag

erD

iscon

tinue

use

of

susp

ect f

eed;

hol

d pr

oduc

t (fis

h) a

nd

exam

ine

for s

afet

yId

entif

y po

tent

ially

im

pact

ed p

rodu

ct

and

rem

ove

from

va

lue

chai

nCo

nduc

t roo

t ca

use

anal

ysis

and

take

act

ion

to p

re-

vent

reoc

curre

nce

Perio

dic

testi

ng

for u

napp

rove

d ch

emic

als

Revi

ew re

cord

s for

fe

ed c

ompo

sitio

n an

d ce

rtific

ates

of

anal

ysis,

dru

g-te

st-in

g re

cord

s

Feed

com

posit

ion

reco

rds

Dru

g te

sting

re

cord

s

Inte

ntio

nal

adul

tera

tion

Mic

robi

al,

chem

ical

, or

phy

sical

co

ntam

ina-

tion

Mon

itorin

g w

orke

rs

and

faci

lity

secu

rity

Ong

oing

Dai

lyQ

A an

d pr

o-du

ctio

n m

anag

er

Prod

uct t

estin

g re

cord

sRe

view

food

de-

fens

e re

cord

sRe

vise

d w

orke

r tra

inin

g pr

ogra

m

and

reco

rds

Food

def

ense

re

cord

sW

orke

r tra

inin

g re

cord

s

UV

or o

zone

–

wat

er

disc

harg

e to

hy

drop

onic

un

it

Path

ogen

ic

bact

eria

Wat

er

qual

ity

mus

t mee

t co

lifor

m

stand

ards

fo

r irri

-ga

tion

wat

er a

nd

be p

atho

-ge

n-fre

e

Wat

er

qual

ity

testi

ng in

fa

cilit

y sh

ows w

a-te

r mee

ts sta

ndar

ds

Ope

ratio

n of

U

V sy

stem

(d

aily

)Ch

eck

and

reco

rd in

ten-

sity

of U

V

light

and

op

erat

iona

l pa

ram

eter

s fo

r (co

nt.)

47

Tabl

e 10

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r fish

cul

turin

g in

cou

pled

aqu

apon

ics

syst

em. (

cont

.)

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

FISH

CU

LTU

RIN

G: C

OU

PLED

SY

STEM

Fish

cul

tur-

ing

or g

row

ou

t (co

nt.)

(con

t.)oz

one

unit,

in

clud

ing

ozon

e le

vels

in

disc

harg

e w

ater

(d

aily

)Cl

eani

ng

sche

dule

to

rem

ove

foul

ing

from

UV

la

mp

unit

(wee

kly

or

as n

eede

d)M

onito

r op

erat

ion

of o

zone

un

its a

nd

ozon

e le

vel

in w

ater

, an

d re

cord

op

erat

iona

l pa

ram

eter

s an

d oz

one

leve

ls (a

t le

ast d

aily

)

Dai

ly/w

eek-

lyQ

A m

anag

erCh

eck

oper

atio

n of

th

e U

V o

r ozo

ne

sani

tatio

n sy

s-te

m a

nd re

pair

as

need

ed; s

witc

h to

al

tern

ativ

e sy

stem

fo

r wat

er p

urifi

ca-

tion

Cond

uct r

oot

caus

e an

alys

is an

d ta

ke a

ctio

n to

pre

-ve

nt re

occu

rrenc

e

Tota

l cou

nts a

nd

targ

eted

pat

hoge

n sa

mpl

es a

naly

zed

(wee

kly)

Revi

ew re

cord

s for

op

erat

ion

of U

V

and

ozon

e sy

stem

s an

d ca

libra

tion

of

mon

itorin

g eq

uip-

men

t (w

eekl

y)Re

view

wat

er fl

ow

and

wat

er q

ualit

y re

cord

sRe

view

lab

test

resu

lts

Dai

ly w

ater

qua

l-ity

and

vol

ume,

m

easu

rem

ent

reco

rds

UV

syste

m re

cord

sO

zone

syste

m

reco

rds

Revi

ew o

f san

ita-

tion

reco

rds (

for

foul

ing

of U

V

unit)

UV

ligh

t cal

ibra

-tio

n re

cord

s (lu

x)O

zone

mon

itor

calib

ratio

n re

cord

sW

ater

flow

and

w

ater

qua

lity

reco

rds

Ana

lytic

al la

b re

sults

48

Tabl

e 11

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r fish

cul

turin

g in

dec

oupl

ed a

quap

onic

s sy

stem

.

Food

Saf

ety

Plan

– P

roce

ss P

reve

ntiv

e C

ontr

ols

Aqu

apon

ic ti

lapi

a –

Blu

e til

apia

(Tila

pia

aure

a) a

nd h

ydro

poni

c le

ttuce

–

Dec

oupl

ed s

yste

m

Gre

en A

quap

onic

s LL

C, 4

56 R

iver

Way

, Aqu

atow

n, W

A 98

765

App

rove

d by

: P. G

reen

S

igna

ture

: P. G

reen

P

eter

Gre

en, P

roce

ssin

g M

anag

er

Vers

ion

2: S

ept.

9, 2

018

Sup

erce

des:

Ver

sion

1: A

ug. 1

, 201

7

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

FISH

CU

LTU

RIN

G: D

ECO

UPL

ED S

YSTE

M

Rece

ivin

g fis

h fin

ger-

ling

Path

ogen

ic

bact

eria

Fish

app

ear

to b

e he

alth

y an

d di

s-ea

se-fr

eeEa

ch lo

t of

finge

rling

s ha

s a h

ealth

ce

rtific

ate

Fish

app

ear-

ance

and

be

havi

orPr

esen

ce o

f ce

rtific

ate

indi

catin

g pa

tho-

gen-

free

finge

rling

s

Visu

al

insp

ec-

tion

of

fish

Each

lot

rece

ived

QA

man

ager

Reje

ct lo

t if c

rit-

ical

lim

it is

not

met

,A

ND

disc

ontin

ue u

se

until

supp

lier

agre

es to

pro

vide

ce

rtific

ate

for e

ach

lot

Revi

ew su

pplie

r pr

ogra

m a

nd u

p-da

te a

udit

prog

ram

as

nee

ded

Cond

uct r

oot

caus

e an

alys

is an

d ta

ke a

ctio

n to

pre

-ve

nt re

occu

rrenc

e

Visit

all

new

su

pplie

rs w

ithin

th

e ye

ar a

nd a

ll ex

istin

g su

pplie

rs

at le

ast o

nce

a ye

ar to

revi

ew th

e gr

ower

’s cu

ltiva

-tio

n fa

cilit

ies,

pro-

cedu

res,

and

fish

heal

th p

rogr

am

Prod

ucer

’s ce

rtif-

icat

esA

udit

repo

rtsRe

ceiv

ing

reco

rd

show

ing

visu

al

insp

ectio

n of

and

re

cord

s fro

m a

ll lo

ts

49

Tabl

e 11

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r fish

cul

turin

g in

dec

oupl

ed a

quap

onic

s sy

stem

. (co

nt.)

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

FISH

CU

LTU

RIN

G: D

ECO

UPL

ED S

YSTE

M

Fish

cul

tur-

ing

or g

row

ou

t

Path

ogen

ic

bact

eria

Feed

is

path

o-ge

n-fre

e

Supp

lier

prov

ides

ce

rtific

ate

or

resu

lts fr

om

third

-par

ty

lab

show

ing

mic

robi

al

load

of f

eed

Visu

al

insp

ec-

tion

of

feed

and

fe

ed

reco

rds

Each

lot

QA

man

ager

Reje

ct lo

t of f

eed

if m

icro

load

is o

ut

of sp

ecRe

view

supp

ly

chai

n pr

ogra

mPr

ovid

e ap

prop

ri-at

e sto

rage

for f

eed

Impr

ove

pest

con-

trol s

yste

mCo

nduc

t roo

t ca

use

anal

ysis

and

take

act

ion

to p

re-

vent

reoc

curre

nce

Reco

rds r

evie

w fo

r ce

rtific

ates

, aud

it re

ports

, rec

eivi

ng

docu

men

tatio

nRe

view

of f

eed

labe

lPe

riodi

c te

sting

of

feed

for p

atho

gens

(m

onth

ly)

Perio

dic

testi

ng

of fi

sh a

nd w

ater

(m

onth

ly)

Lab

resu

lts fo

r w

ater

Lab

resu

lts fo

r fee

dLa

b re

sults

for fi

sh

Path

ogen

ic

bact

eria

W

ater

is sa

feW

ater

is n

ot

cont

ami-

nate

d; U

V

or o

zone

sy

stem

fu

nctio

ning

ac

cord

ing

to

man

ufac

tur-

er st

anda

rds

Ope

ra-

tion

of

UV

or

ozon

e sy

stem

, ap

pear

-an

ce,

arom

a,

and

pH

of w

ater

Dai

lyQ

A m

anag

erTr

eat w

ater

to

rega

in m

icro

bial

co

ntro

lCo

nduc

t roo

t ca

use

anal

ysis

and

take

act

ion

to p

re-

vent

reoc

curre

nce

Wee

kly

wat

er te

st-in

g fo

r mic

robe

sRe

view

of U

V o

r oz

one

oper

atio

n,

light

inte

nsity

, pH

, tem

pera

ture

re

cord

sCa

libra

tion

reco

rds

for U

V a

nd o

zone

m

onito

ring

equi

p-m

ent a

nd th

eir

revi

ewM

icro

bial

test

reco

rds

Testi

ng re

cord

s an

d ce

rtific

ates

Testi

ng re

cord

s an

d ce

rtific

ates

for

mon

thly

wel

l tes

t re

sults

50

Tabl

e 11

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r fish

cul

turin

g in

dec

oupl

ed a

quap

onic

s sy

stem

. (co

nt.)

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

FISH

CU

LTU

RIN

G: D

ECO

UPL

ED S

YSTE

M

Fish

cul

tur-

ing

or g

row

ou

t (co

nt.)

Ant

ibio

tics

or o

ther

ch

emic

als

Feed

is fr

ee

from

un-

appr

oved

ch

emic

als

Certi

ficat

e sh

owin

g dr

ug-fr

ee

feed

Each

lot

Each

lot

QA

man

ager

Disc

ontin

ue u

se o

f co

ntam

inat

ed fe

ed

and

revi

ew su

pply

ch

ain

prog

ram

Cond

uct r

oot

caus

e an

alys

is an

d ta

ke a

ctio

n to

pre

-ve

nt re

occu

rrenc

e

Perio

dic

testi

ng fo

r un

appr

oved

che

m-

ical

s (qu

arte

rly)

Reco

rds r

evie

w

Feed

reco

rds

Dru

g te

sting

re

cord

s

Inte

ntio

nal

adul

tera

tion

Mic

robe

s or

chem

ical

s no

t add

ed

Mon

itorin

g w

orke

rs

and

faci

lity

secu

rity

Ong

oing

Dai

lyQ

A an

d pr

o-du

ctio

n m

anag

er

Hol

d pr

oduc

t and

ex

amin

e fo

r saf

ety

Cond

uct r

oot

caus

e an

alys

is an

d ta

ke a

ctio

n to

pre

-ve

nt re

occu

rrenc

e

Prod

uct t

estin

g re

cord

s rev

iew

Food

def

ense

re-

cord

s and

wor

ker

train

ing

Reco

rds r

evie

w

Food

def

ense

re

cord

sW

orke

r tra

inin

g re

cord

s

UV

or

ozon

e di

scha

rge

to

hydr

opon

ic

unit

Path

ogen

ic

bact

eria

Wat

er q

uali-

ty m

ust m

eet

colif

orm

sta

ndar

ds

Wat

er q

ual-

ity te

sting

in

faci

lity

show

s wat

er

mee

ts sta

n-da

rds

Ope

ra-

tion

of

UV

or

ozon

e sy

stem

Dai

lyQ

A m

anag

erCh

eck

oper

atio

n of

th

e U

V o

r ozo

ne

syste

m a

nd re

pair

as n

eede

d; sw

itch

to a

ltern

ativ

e sy

stem

for w

ater

pu

rifica

tion

Cond

uct r

oot

caus

e an

alys

is an

d ta

ke a

ctio

n to

pre

-ve

nt re

occu

rrenc

e

UV

ligh

t rec

ords

Clea

ning

sche

dule

an

d re

cord

s Re

view

sani

tatio

n re

cord

s Ve

rify

ozon

e sy

s-te

m o

pera

tion

and

revi

ew re

cord

sW

ater

flow

and

w

ater

qua

lity

revi

ew re

cord

s

Dai

ly w

ater

qua

lity

and

volu

me

mea

-su

rem

ents

reco

rds

UV

or o

zone

sy

stem

ope

ratio

n re

cord

sSa

nita

tion

reco

rds

(for f

oulin

g of

UV

un

it)U

V li

ght c

alib

ra-

tion

reco

rds (

lux)

Ozo

ne m

onito

ring

equi

pmen

t Ca

libra

tion

reco

rds

Mic

robi

olog

ical

te

st re

sults

51

Tabl

e 12

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r liv

e fis

h pr

oces

sing

.

Food

Saf

ety

Plan

– P

roce

ss P

reve

ntiv

e C

ontr

ols

Aqu

apon

ic ti

lapi

a –

Blu

e til

apia

(Tila

pia

aure

a) a

nd h

ydro

poni

c le

ttuce

. Fi

sh p

roce

ssin

g –

live

fish

Gre

en A

quap

onic

s LL

C, 4

56 R

iver

Way

, Aqu

atow

n, W

A 98

765

App

rove

d by

: P. G

reen

S

igna

ture

: P. G

reen

P

eter

Gre

en, P

roce

ssin

g M

anag

er

Vers

ion

2: S

ept.

9, 2

018

Sup

erce

des:

Ver

sion

1: A

ug. 1

, 201

7

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

FI

SH P

ROC

ESSI

NG

: LIV

E FI

SHRe

ceiv

e fis

h fo

r pro

cess

-in

g

Path

ogen

ic

mic

robi

al

cont

ami-

natio

n an

d gr

owth

Sens

ory

prop

ertie

s of

fish

Prov

ide

mon

itor-

ing

data

fro

m fo

od

safe

ty p

lan,

in

clud

ing

sani

tatio

n;

insp

ect fi

sh

for v

isual

de

fect

sTe

m-

pera

ture

co

ntro

l and

m

onito

ring

of p

roce

ss-

ing

room

Visu

alEa

ch lo

tQ

A m

anag

erRe

ject

lot i

f it d

oes

not m

eet s

enso

ry

or ta

rget

tem

pera

-tu

reCo

nduc

t roo

t ca

use

anal

ysis

and

take

act

ion

to p

re-

vent

reoc

curre

nce

Sam

ples

from

fish

an

d m

eat t

este

d pe

riodi

cally

for

mic

robe

sPr

ovid

es th

ird-p

ar-

ty c

ertifi

cate

and

la

b re

sults

for l

ots

sam

pled

qua

rterly

Revi

ew sa

nita

tion

reco

rds,

tem

pera

-tu

re re

cord

s, an

d ca

libra

tion

reco

rds

Sani

tatio

n re

cord

sLa

b re

sults

from

pe

riodi

c m

icro

bio-

logi

cal t

estin

g Th

erm

omet

er c

ali-

brat

ion

reco

rds

Tem

pera

ture

re

cord

s

52

Tabl

e 12

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r liv

e fis

h pr

oces

sing

. (co

nt.)

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

FI

SH P

ROC

ESSI

NG

: LIV

E FI

SHLa

belin

gA

llerg

ens

Prop

er la

bel

Labe

ls on

fin

ished

pr

oduc

t mus

t ha

ve c

om-

mon

nam

e of

fis

h, so

urce

, an

d lo

t num

-be

rA

llerg

en

war

ning

la-

bel i

s pre

sent

Prop

er

labe

lA

ttach

on

e la

bel

to re

cord

la

belin

g sh

eet e

ach

time

new

la

bels

are

used

Visu

al

insp

ec-

tion

of

labe

l for

ac

cura

cy

Ever

y tim

e la

bels

are

appl

ied

Pack

-ag

ing

supe

rvi-

sor

Segr

egat

e an

d re

-labe

l any

im-

prop

erly

labe

led

prod

uct

Mod

ify la

belin

g pr

oced

ure

as a

p-pr

opria

te

Labe

l and

labe

ling

reco

rds r

evie

wLa

bel

Labe

ling

reco

rds

Trac

eabi

lity

Labe

ls on

fin

ished

pr

oduc

t mus

t ha

ve c

lear

lo

t cod

e

Lot c

ode

pres

ent a

nd

read

able

Visu

alEa

ch p

acka

gePa

ck-

agin

g su

perv

i-so

r

Segr

egat

e an

d re

-labe

l any

im-

prop

erly

labe

led

prod

uct

Mod

ify la

belin

g pr

oced

ure

as a

p-pr

opria

te

Labe

l and

labe

ling

reco

rds r

evie

wLa

bel

Labe

ling

reco

rds

Tam

per

evid

ence

Tam

per-e

vi-

dent

feat

ure

pres

ent a

nd

func

tiona

l

Tam

-pe

r-evi

dent

fe

atur

e is

desc

ribed

on

labe

l; fe

atur

e pr

esen

t and

fu

nctio

nal

Visu

alEa

ch p

acka

gePa

ck-

agin

g su

perv

i-so

r

Segr

egat

e af

fect

ed

pack

ages

and

reap

-pl

y ta

mpe

r-evi

dent

fe

atur

eM

odify

labe

ling

proc

edur

e as

ap-

prop

riate

Pack

reco

rds

revi

ewPa

ck re

cord

s

Econ

omic

fra

udPr

oper

labe

lW

eigh

t and

sp

ecie

s is

accu

rate

Visu

alEa

ch p

acka

gePa

ck-

agin

g su

perv

i-so

r

Segr

egat

e af

fect

-ed

pac

kage

and

re

-labe

lM

odify

labe

ling

proc

edur

e as

ap-

prop

riate

Labe

ling

and

pack

re

cord

s rev

iew

Calib

ratio

n re

cord

s re

view

Labe

ling

reco

rds

Pack

ing

reco

rds

Scal

e ca

libra

tion

reco

rds

53

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

FI

SH P

ROC

ESSI

NG

: LIV

E FI

SH, B

LED

, AN

D E

VIS

CER

ATED

Rece

ive

fish

for p

roce

ss-

ing

Path

ogen

ic

bact

eria

Sens

ory

qual

ity o

f fis

h, te

m-

pera

ture

of

fish

Prov

ide

mon

itor-

ing

data

fro

m fo

od

safe

ty p

lan,

in

clud

ing

revi

ew o

f sa

nita

tion

reco

rds

to sh

ow

cont

rol

in e

arlie

r op

erat

ions

Insp

ect fi

sh

for v

isual

de

fect

s in-

dica

tive

of

mic

robi

al

grow

th

Visu

alEa

ch lo

tQ

A m

an-

ager

Reje

ct lo

t if i

t doe

s no

t mee

t sen

sory

or

targ

et te

mpe

ra-

ture

Co

nduc

t roo

t ca

use

anal

ysis

and

take

act

ion

to p

re-

vent

reoc

curre

nce

Sam

ples

from

fish

an

d m

eat t

este

d pe

riodi

cally

for

APC

, Sal

mon

ella

sp

p., L

mon

ocyt

o-ge

nes

Prov

ides

third

-par

-ty

cer

tifica

te a

nd

lab

resu

lts fo

r lot

s sa

mpl

ed q

uarte

rlyRe

view

sani

tatio

n an

d la

b re

cord

s

Sani

tatio

n re

cord

s

Lab

resu

lts fr

om

perio

dic

testi

ng

Tabl

e 13

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r who

le fi

sh p

roce

ssin

g.

Food

Saf

ety

Plan

– P

roce

ss P

reve

ntiv

e C

ontr

ols

Aqu

apon

ic ti

lapi

a –

Blu

e til

apia

(Tila

pia

aure

a) a

nd h

ydro

poni

c le

ttuce

Fish

pro

cess

ing

– W

hole

fish

, ble

d an

d ev

isce

rate

d

Gre

en A

quap

onic

s LL

C, 4

56 R

iver

Way

, Aqu

atow

n, W

A 98

765

App

rove

d by

: P. G

reen

S

igna

ture

: P. G

reen

P

eter

Gre

en, P

roce

ssin

g M

anag

er

Vers

ion

2: S

ept.

9, 2

018

Sup

erce

des:

Ver

sion

1: A

ug. 1

, 201

7

54

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

FI

SH P

ROC

ESSI

NG

: LIV

E FI

SH, B

LED

, AN

D E

VIS

CER

ATED

Rece

ive

fish

for p

roce

ss-

ing

(con

t.)

Mic

robi

al

grow

thPr

oces

s ro

om a

nd

prod

uct t

em-

pera

ture

Tem

pera

-tu

re c

ontro

l an

d m

on-

itorin

g of

te

mpe

ratu

re

in p

roce

ss-

ing

room

Ther

mom

-et

erTw

ice

daily

Pro-

duct

ion

man

ager

Redu

ce T

for

HVA

C sy

stem

and

re

test

Add

sani

tary

ice

if ne

eded

to k

eep

fish

cool

Cond

uct r

oot

caus

e an

alys

is an

d ta

ke a

ctio

n to

pre

-ve

nt re

occu

rrenc

e

Revi

ew te

mpe

ra-

ture

and

tem

pera

-tu

re c

alib

ratio

n re

cord

s

Tem

pera

ture

re

cord

sTh

erm

omet

er c

al-

ibra

tion

reco

rds

Was

hing

Path

ogen

ic

bact

eria

Chlo

rine

be-

twee

n 2

and

4 pp

m in

w

ash

wat

er

Chlo

rine

test

resu

ltsCh

lorin

e te

st ki

tEv

ery

hour

QA

man

-ag

erA

djus

t chl

orin

e le

vels

as n

eede

dCh

eck

calib

ratio

n an

d en

sure

that

ch

lorin

e m

easu

re-

men

ts ar

e be

ing

prop

erly

mad

eCo

nduc

t roo

t ca

use

anal

ysis

and

take

act

ion

to p

re-

vent

reoc

curre

nce

Calib

ratio

n re

sults

fo

r chl

orin

e te

st ki

tRe

view

chl

orin

e te

st an

d m

unic

ipal

w

ater

reco

rds

Chlo

rine

test

reco

rds

Mun

icip

al w

ater

te

st re

ports

Wei

gh,

pack

, lab

elM

icro

bial

co

ntam

i-na

tion

and

grow

th

Stor

ed fi

sh

mus

t be

mai

ntai

ned

at in

tern

al

tem

pera

ture

of

less

than

45

F

Look

for

pres

ence

of

ice

and

reco

rd in

-te

rnal

tem

-pe

ratu

re o

f 2

fish/

100

lbs.

Visu

alEv

ery

hour

QA

man

-ag

erA

dd ic

e w

hen

need

edO

Rad

d ic

e if

inte

r-na

l T >

45

F an

d re

chec

k te

mpe

ra-

ture

s to

mak

e su

re

fish

tem

pera

ture

is

belo

w 4

5 F

Han

d-he

ld d

igita

l th

erm

omet

er u

sed

to ta

ke in

ter-

nal t

empe

ratu

re

calib

rate

d w

eekl

y;

if ou

tside

+/-

2 F,

re

plac

e w

ith n

ew

one

Revi

ew te

mpe

ra-

ture

reco

rds

Reco

rds o

f int

er-

nal t

empe

ratu

re o

f fis

h at

rece

ipt a

nd

durin

g pr

oces

sing

Dai

ly p

roce

ssin

g ro

om te

mpe

ra-

ture

s

Tabl

e 13

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r who

le fi

sh p

roce

ssin

g. (c

ont.)

55

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

FI

SH P

ROC

ESSI

NG

: LIV

E FI

SH, B

LED

, AN

D E

VIS

CER

ATED

Wei

gh,

pack

, lab

el

(con

t.)

Revi

ew p

roce

ss

room

and

ther

mom

-et

er c

alib

ratio

n re

cord

sRe

view

sani

tatio

n re

cord

s – ic

e is

sani

tary

Revi

ew w

ater

qu

ality

sani

tatio

n re

cord

s

Wee

kly

calib

ra-

tion

of h

and-

held

di

gita

l the

rmom

-et

erIc

e pr

oduc

tion

and

sani

tatio

n re

cord

s

Alle

rgen

sLa

bel a

ccu-

racy

Labe

ls on

fin

ished

pr

oduc

t m

ust h

ave

com

mon

na

me

of

fish,

sour

ce,

and

lot

num

ber

Visu

alA

ttach

on

e la

bel

to re

cord

la

belin

g sh

eet e

ach

time

new

la

bels

are

mad

e

Ever

y tim

e la

bels

are

appl

ied

Pack

agin

g su

perv

isor

Segr

egat

e an

d re

-labe

l any

im-

prop

erly

labe

led

prod

uct

Mod

ify la

belin

g pr

oced

ure

Revi

ew o

f la-

bel a

nd la

belin

g re

cord

s

Labe

lLa

belin

g re

cord

Trac

eabi

lity

Lot c

ode

pres

ent a

nd

read

able

Alle

rgen

w

arni

ng

labe

l pre

sent

Labe

ls on

fin

ished

pr

od-

uct m

ust

incl

ude

lot

num

ber

Visu

alEa

ch p

ack-

age

Pack

agin

g su

perv

isor

Segr

egat

e an

d re

-labe

l any

im-

prop

erly

labe

led

prod

uct

Mod

ify la

belin

g pr

oced

ure

as a

p-pr

opria

te

Revi

ew la

bels

and

labe

l rec

ords

Labe

lLa

belin

g re

cord

s

Tam

per

evid

ence

Labe

l and

fe

atur

eTa

mpe

r-evi

-de

nt fe

atur

e de

scrib

ed

on la

bel i

s pr

esen

t and

fu

nctio

nal

Visu

alEa

ch p

ack-

age

Pack

agin

g su

perv

isor

Segr

egat

e af

fect

ed

pack

ages

and

reap

-pl

y ta

mpe

r-evi

dent

fe

atur

e

Revi

ew la

bels

and

labe

l rec

ords

Labe

lLa

belin

g re

cord

s

Tabl

e 13

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r who

le fi

sh p

roce

ssin

g.

56

Tabl

e 14

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r let

tuce

cul

tivat

ion.

Food

Saf

ety

Plan

– P

roce

ss P

reve

ntiv

e C

ontr

ols

Aqu

apon

ic ti

lapi

a –

Blu

e til

apia

(Tila

pia

aure

a) a

nd h

ydro

poni

c le

ttuce

–

Lettu

ce c

ultiv

atio

n

Gre

en A

quap

onic

s LL

C, 4

56 R

iver

Way

, Aqu

atow

n, W

A 98

765

App

rove

d by

: P. G

reen

S

igna

ture

: P. G

reen

P

eter

Gre

en, P

roce

ssin

g M

anag

er

Vers

ion

2: S

ept.

9, 2

018

Sup

erce

des:

Ver

sion

1: A

ug. 1

, 201

7

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

LETT

UC

E C

ULT

IVAT

ION

Rece

ive

lettu

ce se

edPa

thog

enic

ba

cter

iaSu

pply

ch

ain

cont

rol,

use

only

ap

prov

ed

supp

liers

, th

ird-p

arty

au

dit

Pres

ence

of

certi

ficat

e in

dica

ting

path

o-ge

n-fre

e se

eds

Visu

alEa

ch lo

t re

ceiv

edQ

A m

an-

ager

Reje

ct lo

t if c

riti-

cal l

imit

is no

t met

AN

Ddi

scon

tinue

use

un

til su

pplie

r ag

rees

to p

rovi

de

com

plia

nt p

rodu

ct

certi

ficat

e fo

r eac

h lo

t

Visit

all

new

sup-

plie

rs w

ithin

the

year

and

all

ex-

istin

g su

pplie

rs a

t le

ast o

nce

a ye

ar

to re

view

seed

op-

erat

ions

or o

btai

n au

dit r

esul

ts fro

m

third

-par

ty a

udito

r (a

nnua

lly)

Test

seed

ship

-m

ents

quar

terly

fo

r pat

hoge

nsRe

view

rece

ivin

g re

cord

s, ce

rtifi-

cate

s, te

st re

cord

s, an

d au

dit r

epor

ts

Prod

ucer

’s ce

rtif-

icat

esA

udit

repo

rtsRe

ceiv

ing

reco

rd

for a

ll lo

tsA

naly

tical

reco

rds

57

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

LETT

UC

E C

ULT

IVAT

ION

Rece

ive

lettu

ce se

ed

(con

t.)

Chem

ical

re

sidue

Supp

ly

chai

n co

ntro

l, ap

prov

ed

supp

lier

third

-par

ty

audi

t

Pres

ence

of

certi

ficat

e in

dica

ting

pesti

-ci

de-fr

ee

seed

s

Visu

alEa

ch lo

t re

ceiv

edQ

A m

an-

ager

Reje

ct lo

t if c

ritic

al

limit

is no

t met

AN

Ddi

scon

tinue

use

un

til su

pplie

r ag

rees

to p

rovi

de

com

plia

nt p

rodu

ct

and

certi

ficat

e fo

r ea

ch lo

t

Visit

all

new

su

pplie

rs w

ithin

th

e ye

ar a

nd a

ll ex

istin

g su

pplie

rs

twic

e pe

r yea

r on

a ro

tatin

g ba

sis to

re

view

seed

op-

erat

ions

or o

btai

n au

dit r

esul

ts fro

m

third

-par

ty a

udito

r (a

nnua

lly)

Test

seed

ship

-m

ents

quar

terly

for

pesti

cide

sRe

view

test

re-

cord

s, re

ceiv

ing

reco

rds,

and

audi

t re

ports

Rece

ivin

g re

cord

fo

r all

lots

Inte

ntio

nal

adul

tera

tion

Supp

ly

chai

n co

ntro

l, ap

prov

ed

supp

lier,

third

-par

ty

audi

t

Visu

al a

nd

sens

ory

insp

ectio

n at

re

ceip

t

Visu

alEa

ch lo

t re

ceiv

edQ

A m

an-

ager

Reje

ct su

spic

ious

sh

ipm

ents,

incl

ud-

ing

reje

ctio

n of

se

edlin

gs th

at fa

il to

thriv

e fo

r no

appa

rent

reas

onCo

nduc

t roo

t cau

se

anal

ysis

and

take

ac

tion

to p

reve

nt

reoc

curre

nce

Revi

ew re

ceiv

ing

logs

and

ger

min

a-tio

n re

cord

s

Rece

ivin

g re

cord

sG

erm

inat

ion

reco

rds

Path

ogen

ic

bact

eria

W

ater

qua

l-ity

mee

ts sp

ecifi

catio

n fo

r irri

ga-

tion

wat

er

qual

ity

Dai

ly w

ater

sa

mpl

ing

for t

urbi

dity

(in

dica

tive

of m

icro

bial

gr

owth

)

Visu

al a

nd

instr

umen

-ta

l tes

ts

Dai

ly w

ater

sa

mpl

es fo

r pH

QA

man

-ag

erRe

pair

or re

plac

e th

e U

V u

nit i

f it

does

not

pro

vide

en

ough

mic

robi

al

redu

ctio

n

Verif

y th

at n

ew

or re

paire

d U

V o

r oz

one

unit

func

-tio

ns p

rope

rlyRe

view

reco

rds

Wat

er q

ualit

y re

cord

s

Tabl

e 14

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r let

tuce

cul

tivat

ion.

(con

t.)

58

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

ncy

Who

LETT

UC

E C

ULT

IVAT

ION

Let

tuce

gr

ow o

ut o

n ra

fts (c

ont.)

Chec

k U

V

oper

atin

g at

pr

oper

ligh

t in

tens

ity a

nd

unit

has n

o fo

ulin

g.Fo

r ozo

ne,

conc

entra

-tio

n in

cul

ti-va

tion

wat

er

is ad

equa

te

for m

icro

bi-

al c

ontro

l

Dai

ly c

heck

of

UV

uni

t or

dai

ly

chec

k on

oz

one

con-

cent

ratio

n in

w

ater

Incr

ease

ozo

ne a

d-di

tion

if m

icro

bial

co

ntro

l ina

dequ

ate

Use

bac

kup

chem

-ic

al sa

nitiz

er, a

nd

if th

is is

not p

os-

sible

, disc

ontin

ue

oper

atio

ns u

ntil

sani

tary

con

ditio

ns

can

be v

erifi

edCo

nduc

t roo

t ca

use

anal

ysis

and

take

act

ion

to p

re-

vent

reoc

curre

nce

Revi

ew la

b,

ozon

e, U

V o

pera

-tio

nal a

nd c

alib

ra-

tion

reco

rds

Lab

resu

lts fo

r UV

or

ozo

ne o

pera

tion

log,

ligh

t int

ensi-

ty a

nd b

ulb

life,

re

cord

s for

ozo

ne

conc

entra

tion

Calib

ratio

n re

-co

rds f

or o

zone

or

UV

mon

itorin

g in

strum

enta

tion

Lettu

ce

harv

estin

gPa

thog

ens

Lettu

ce

– ge

nera

l ap

pear

ance

, se

nsor

y qu

ality

, and

sig

ns o

f m

icro

bial

lo

ad

Visu

al in

-sp

ectio

nVi

sual

Each

lot

QA

man

-ag

erRe

train

if p

rope

r ha

nd-w

ashi

ng a

nd

tool

sani

tatio

n pr

actic

es a

re n

ot

follo

wed

dur

ing

harv

estin

gVe

rify

glov

e us

e du

ring

harv

estin

g an

d ha

ndlin

gSe

greg

ate

susp

ect-

ed p

rodu

ct a

nd d

o no

t shi

pCo

nduc

t roo

t ca

use

anal

ysis

for

sour

ce o

f mic

robi

-al

con

tam

inat

ion

Verif

y sa

nita

tion

proc

edur

es a

nd

sani

tizer

con

cen-

tratio

nTe

st le

ttuce

for

bact

eria

wee

kly

Revi

ew o

f pro

d-uc

t har

vest

and

qual

ity re

cord

s, la

b re

cord

s, an

d sa

nita

tion

reco

rds

Prod

uct h

arve

st an

d qu

ality

re-

cord

sLa

b re

cord

sSa

nita

tion

reco

rds

Tabl

e 14

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r let

tuce

cul

tivat

ion.

(con

t.)

59

Tabl

e 15

. Foo

d sa

fety

pla

n: P

roce

ss p

reve

ntiv

e co

ntro

ls fo

r let

tuce

pro

cess

ing.

Food

Saf

ety

Plan

– P

roce

ss P

reve

ntiv

e C

ontr

ols

Aqu

apon

ic ti

lapi

a –

Blu

e til

apia

(Tila

pia

aure

a) a

nd h

ydro

poni

c le

t-tu

ce –

Let

tuce

pro

cess

ing

Gre

en A

quap

onic

s LL

C, 4

56 R

iver

Way

, Aqu

atow

n, W

A 98

765

App

rove

d by

: P. G

reen

S

igna

ture

: P. G

reen

P

eter

Gre

en, P

roce

ssin

g M

anag

er

Vers

ion

2: S

ept.

9, 2

018

Sup

erce

des:

Ver

sion

1: A

ug. 1

, 201

7

Proc

ess

cont

rol

step

Haz

ard(

s)

Para

met

er,

valu

es,

or c

ritic

al

limits

Mon

itorin

g

Cor

rect

ive

actio

nVe

rifica

tion

Rec

ords

Wha

tH

owFr

eque

n-cy

Who

LE

TTU

CE

PRO

CES

SIN

GRe

ceiv

e le

ttuce

Path

ogen

sVi

sual

exa

m

and

sam

plin

g fo

r tes

ting

App

ear-

ance

Visu

alEa

ch lo

tQ

A m

an-

ager

Reje

ct if

mic

ro

tests

out

of s

pec

Perio

dic

lab

testi

ng a

nd re

view

re

cord

s

Rece

ivin

g la

b re

sults

Was

h an

d dr

ain

Path

ogen

sCh

lorin

e 2-

4 pp

m, p

H 6

.5Ch

lorin

e te

st ki

ts

pH

Visu

al

pH m

eter

Hou

rlyQ

A m

an-

ager

Disc

ontin

ue

proc

essin

g un

til

chlo

rine

leve

l is

suffi

cien

t for

sani

-tiz

atio

nCh

eck

the

chlo

-rin

e so

urce

; if i

t is

deac

tivat

ed, a

dd

mor

e fre

sh c

hlo-

rine

Verif

y op

erat

ion

of

chlo

rine

addi

tion

unit

Reco

rds r

evie

w

Reco

rds o

f chl

o-rin

e co

ncen

tratio

n an

d pH

Met

al a

nd

phys

ical

ob

ject

s in

spec

tion

Met

als

Met

als i

nclu

-sio

nVi

sual

ex

am fo

r m

etal

Visu

alEa

ch lo

tQ

A m

an-

ager

If m

etal

foun

d,

hold

pro

duct

and

re

chec

k th

e re

st of

the

lot p

rior t

o re

leas

e.Co

nduc

t roo

t ca

use

anal

ysis

and

take

act

ion

to p

re-

vent

reoc

curre

nce.

Perio

dica

lly v

erify

th

at p

roce

ssor

s can

de

tect

thes

e m

a-te

rials

(trai

ning

). Re

view

insp

ectio

n re

cord

s.

Insp

ectio

n re

cord

s

60

Tabl

e 16

. Foo

d sa

fety

pla

n: A

llerg

en p

reve

ntiv

e co

ntro

ls fo

r fish

pro

duct

s.

Food

Saf

ety

Plan

– A

llerg

en P

reve

ntiv

e C

ontr

ols

Aqu

apon

ic ti

lapi

a –

Blu

e til

apia

(Tila

pia

aure

a)

Gre

en A

quap

onic

s LL

C, 4

56 R

iver

Way

, Aqu

atow

n, W

A 98

765

App

rove

d by

: P. G

reen

S

igna

ture

: P. G

reen

Pet

er G

reen

, Pro

cess

ing

Man

ager

Vers

ion

2: S

ept.

9, 2

018

Sup

erce

des:

Ver

sion

1: A

ug. 1

, 201

7

(1) A

l-le

rgen

co

ntro

l(2

) Haz

-ar

d(3

) C

riter

ion

Mon

itorin

g(8

) C

orre

ctiv

e ac

tion

(9)

Verifi

catio

n(1

0)

Rec

ords

(4)

Wha

t(5

) H

ow(6

) Fr

eque

ncy

(7)

Who

Fi

shU

nde-

clar

ed

alle

rgen

Prod

uct

mus

t co

ntai

n al

lerg

en

decl

ara-

tion:

“IN

GRE

-D

IEN

TS:

Fish

: til

apia

”

Pres

ence

or

abse

nce

or

alle

rgen

dec

la-

ratio

n

Trai

ned

em-

ploy

ee (p

ack-

agin

g le

ad)

chec

ks p

rodu

ct

labe

ling

at th

e be

ginn

ing

and

end

of e

ach

shift

and

on

lot c

hang

esTr

aine

d em

-pl

oyee

reco

rds

obse

rvat

ions

on

pac

kagi

ng

reco

rds

Begi

nnin

g an

d en

d of

eac

h sh

ift a

nd o

n lo

t cha

nges

Pack

agin

g le

adIn

the

even

t tha

t th

e al

lerg

en d

ec-

lara

tion

is no

t on

the

labe

l, pa

ck-

agin

g le

ad w

ill

notif

y su

perv

isor

and

plac

e af

fect

ed

prod

uct o

n ho

ld

until

the

last

good

ch

eck

Prod

uct i

s the

n pr

oper

ly la

bele

dRo

ot c

ause

ana

l-ys

is co

nduc

ted

to

dete

rmin

e w

hy

failu

re o

ccur

red,

an

d iss

ue is

cor

-re

cted

Labe

l rev

iew

Labe

ling

reco

rds a

re

revi

ewed

and

ve

rified

by

QC

Pack

agin

g re

cord

s

61

Table 17. Fish products labeling.

Products Allergen Statement

Tilapia INGREDIENTS: Tilapia

Product name Production line

Intentional Allergens

Egg Milk Soy Wheat Tree nut Peanut Fish Shellfish

Tilapia All facility equipment

N/A N/A N/A N/A N/A N/A Declared N/A

62

Tabl

e 18

. Foo

d sa

fety

pla

n: A

llerg

en p

reve

ntiv

e co

ntro

ls fo

r let

tuce

.

Food

Saf

ety

Plan

– A

llerg

en P

reve

ntiv

e C

ontr

ols

Aqu

apon

ics

lettu

ce

Gre

en A

quap

onic

s LL

C, 4

56 R

iver

Way

, A

quat

own,

WA

9876

5

App

rove

d by

: P. G

reen

Sig

natu

re: P

. Gre

en

Pro

cess

ing

Man

ager

Vers

ion

2: S

ept.

9, 2

018

Sup

erce

des:

Ver

sion

1: A

ug. 1

, 201

7

(1) A

l-le

rgen

co

ntro

l(2

) Haz

-ar

d(3

) C

riter

ion

Mon

itorin

g(8

) C

orre

ctiv

e ac

tion

(9)

Verifi

catio

n(1

0)

Rec

ords

(4)

Wha

t(5

) H

ow(6

) Fr

eque

ncy

(7)

Who

Fi

shU

nde-

clar

ed

alle

rgen

Prod

uct

mus

t co

ntai

n al

lerg

en

decl

ara-

tion:

“I

NG

RE-

DIE

NTS

: Le

ttuce

, pr

oduc

ed

in a

faci

li-ty

that

also

pr

oces

ses

fish

(tila

-pi

a)”

Pres

ence

or

abse

nce

or

alle

rgen

dec

la-

ratio

n:

“Pro

duce

d in

a

faci

lity

that

al

so p

roce

sses

fis

h (ti

lapi

a)”

Trai

ned

em-

ploy

ee (p

ack-

agin

g le

ad)

chec

ks p

rodu

ct

labe

ling

at th

e be

ginn

ing

and

end

of e

ach

shift

and

on

lot c

hang

es E

mpl

oy-

ee re

cord

s ob

serv

atio

ns

on p

acka

ging

re

cord

s

Begi

nnin

g an

d en

d of

eac

h sh

ift a

nd o

n lo

t cha

nges

Pack

agin

g le

adIn

the

even

t tha

t th

e al

lerg

en d

ec-

lara

tion

is no

t on

the

labe

l, pa

ck-

agin

g le

ad w

ill

notif

y su

perv

isor

and

plac

e af

fect

ed

prod

uct o

n ho

ld

until

the

last

good

ch

eck

Prod

uct i

s rel

a-be

led

Root

cau

se

anal

ysis

cond

uct-

ed to

det

erm

ine

why

dev

iatio

n oc

curre

d, a

nd

steps

take

n to

fix

defic

ienc

y

Labe

l rev

iew

Reco

rds a

re

revi

ewed

and

ve

rified

by

QC

Pack

agin

g re

cord

s

63

Table 19. Lettuce products labeling.

Products Allergen Statement

Lettuce INGREDIENTS: Lettuce, produced in a facility that also processes fish (tilapia)

Product name Production line

Intentional Allergens

Egg Milk Soy Wheat Tree nut Peanut Fish Shellfish

Lettuce All facility equipment N/A N/A N/A N/A N/A N/A Declared N/A

64

Tabl

e 20

. San

itatio

n pr

even

tive

cont

rol:

Faci

lity

sani

tatio

n m

onito

ring

mas

ter l

ist.

Equi

pmen

tPr

oces

s m

onito

rSO

P/fo

rmM

onito

ring

freq

uenc

yA

ctio

n lim

itC

orre

ctio

nR

ecor

ds/

loca

tion

Pers

on re

-sp

onsi

ble

Mon

itor-

ing

reco

rd

revi

ewPe

rson

re-

spon

sibl

e

Prod

uct c

on-

tact

surfa

ces

Visu

al in

-sp

ectio

nD

aily

pre

-op

insp

ectio

n lo

gD

aily

Visib

le so

ilRe

clea

n an

d re

sani

tize

un-

til v

isibl

e so

il is

rem

oved

QC

offic

eD

epar

tmen

t m

anag

erD

aily

pre

-op

insp

ectio

n lo

gQ

C m

anag

er

Non

prod

uct

cont

act s

ur-

face

s

Visu

al in

-sp

ectio

nM

aste

r san

i-ta

tion

sche

d-ul

e

As d

eter

-m

ined

on

sche

dule

As d

eter

-m

ined

on

sche

dule

Recl

ean

and

resa

nitiz

e un

til v

isual

ly

clea

n

QC

offic

ePr

oduc

tion

empl

oyee

sM

aste

r san

i-ta

tion

sche

d-ul

e

QC

or d

epar

t-m

ent m

an-

ager

Tabl

e 21

. San

itatio

n pr

even

tive

cont

rols

: Fac

ility

san

itatio

n ve

rifica

tion

activ

ities

.

Equi

pmen

t/re

cord

Verifi

catio

n ac

tivity

SOP/

form

Freq

uenc

yA

ctio

n lim

itPe

rson

re-

spon

sibl

eC

orre

ctiv

e ac

tion

Impl

emen

tPe

rson

re-

spon

sibl

eR

ecor

ds/

loca

tion

Prod

uct c

on-

tact

surfa

ces

Ade

nosin

e tri

phos

phat

e (A

TP) s

wab

-bi

ng

SSO

P AT

P sw

abs

Dai

ly0-

10RL

U:

Pass

11-3

0 RL

U:

Caut

ion

31 R

LU <

: Fa

ilCh

eck

the

kit

man

ufac

ture

r m

anua

ls fo

r in

struc

tion

and

actio

n lim

its

Prod

uctio

n em

ploy

eeRe

clea

n an

d re

sani

tize

un-

til A

TP re

sults

m

eet a

ctio

n lim

it

N/A

QC

man

ager

QC

offic

e

65

Tabl

e 22

. San

itatio

n pr

even

tive

cont

rols

: Fac

ility

san

itatio

n im

plem

enta

tion/

effe

ctiv

enes

s.

Test

Equi

pmen

t/ re

agen

tC

alib

ratio

nC

alib

ratio

n fr

eque

ncy

SOP

#Pe

rson

re-

spon

sibl

eR

ecor

ds/lo

-ca

tion

Mon

itorin

g re

cord

re-

view

Pers

on re

-sp

onsi

ble

Envi

ronm

en-

tal s

wab

bing

(L

ister

ia sp

p.)

Spon

ge st

ick

swab

Cont

rols

are

run

by o

utsid

e la

bora

tory

for

the

met

hods

us

ed to

test

the

spon

ge

Dai

lyPr

ovid

ed b

y la

bora

tory

QA

man

ager

QC

offic

e an

d ou

tside

labo

ra-

tory

QC

man

ager

QC

man

ager

ATP

swab

bing

an

d te

sting

Nov

a LU

M II

or

equ

ival

ent

Posit

ive

and

nega

tive

con-

trols

• Neg

ativ

e co

n-tro

l = m

onth

ly• P

ositi

ve c

on

trol

= m

onth

ly

ATP

swab

bing

an

d te

sting

Qua

lity

depa

rt-m

ent a

ssoc

iate

or

des

igne

e

Qua

lity

depa

rt-m

ent

ATP

cont

rols:

pe

rform

ance

ch

ecks

Qua

lity

depa

rt-m

ent a

ssoc

iate

or

des

igne

e

66

Table 23. Food protection plan.

Food protection – General factors Unsatisfactory Satisfactory

• Trained designated employee(s) in charge of food safety plan for fish production, plant production, GMPs, SOPs, supply chain controls, sanitary transport, and food defense.

• Trained designated employee(s) trained on vulnerability assessment, actionable process steps, and mitigation strategies to significantly minimize risk of intentional contamination.

• Trained individual in plant phytosanitary best practices and fish health.

• No trained employees. • Trained employee(s).

• Designated employees attend food safety training courses or receives sufficient training on-site to ensure they are capable of successfully performing these tasks.

Food Safety Plan: General Assessment Information

Assessment – Food Protection Our employees are trained to meet the technical and documented training requirements of 21 CFR Parts 11, 112, 117, 121, and 123, as per the requirements of their jobs. At least one person on each shift has received training to serve as a qualified individual, as appropriate, for produce production under the Produce Safety Rule, or is trained to serve as a preventive controls qualified individual for food processing. Individuals who have had seafood HACCP training should become familiar with the new requirements of Food Safety Modernization Act, either on their own or through additional training so they have the background information needed to serve as a Preventive Controls Qualified Individual (PCQI). These individual(s) will be required to prepare the food safety plan, develop the hazard analysis, validate the preventive controls,

review food safety and food protection records, and conduct a re-analysis of the food safety plan. The individual(s) will be deemed to be capable through successful work performance of these tasks, although attendance at a course in one or more of the regulations listed here is anticipated. A qualified individual in our facility will also be one who understands the importance of sanitation and biosecurity and can implement an effective plan to reduce the risk for human, animal, and plant disease in our operation. There will be at least one qualified individual on-site at all times who has training and understanding of the intentional adulteration rule and how it is to be implemented at our facility.

Any worker or contractor who has a role in ensuring some aspect of food safety will have training that is documented with records retained in personnel or contractor files. Training for all employees is updated as hazard analyses change or at least twice per year. Table 23 provides an assessment rubric showing when a food protection plan is satisfactory and when it is not.

67


• Written and documented hazard analysis and food protection plan, including food defense, GMPs, and SOPs.

• Written plant and animal protection programs.

• No food safety plan, GMPs, or SOPs are available.

• No updated HACCP/HARPC hazard analysis.

• No updated GMPs and SOPs.

• FSMA compliance lacking.

• Phytosanitary and biosecurity provisions lacking.

• Well-written and available food protection plan, GMPs, and SOPs.

• Plan adequately addresses food defense.

• Well-drafted biosecurity protocols.

• Indication that food safety plan and SOPs are re-evaluated and updated when there is a change in product, process, or distribution that could affect food safety, and at least annually (21 CFR Part 123 Seafood HACCP).

• Staff is familiar with FSMA requirements.

• Staff is familiar with plant and animal health requirements and biosecurity measures.

• Visitor protocol program in place. • Visitors come and visit with no supervision, posing a biosecurity, food safety, and food defense risk.

• Visitors bring animals on-site.

• Visitors do not comply with dress or personal protective equipment requirements on-site.

• No indication that visitors have received any training about the facility and facility’s food safety requirements.

• Visitor policies developed and implemented.

• Visitor hygiene protocol developed and implemented.

• Visitor plant health and animal biosecurity protocols developed and implemented.

• Visitor supervision protocol developed and implemented.

Table 23. Food protection plan. (cont.)

68


• Written pest control program.

• Written domestic animal policies.

• Pests (insects, rodents, birds) have access to production, processing, and material storage areas.

• Animal waste near production or processing areas; improper waste management could attract pests.

• Improper feed storage; feed not isolated and protected, giving pests access to food and transmission of pathogens (viruses, Salmonella spp., E. coli, etc.).

• Third-party pest control with regu-lar checking.

• Proper feed storage.

• Feed kept in designated storage room, isolated from other dry goods and packaging.

• Warm-blooded animals kept out of facility.

• Any domestic animals are away from production and processing areas, preferably at the edge of property (for guard animals).

• Employees trained about possible sources of cross-contamination when moving between fish pro-duction site and lettuce production unit.

• Required use of boot sanitation stations outside the fish production and processing sites and the lettuce production and processing units.

• Proper maintenance of boot sanita-tions stations and footwear, includ-ing footwear storage; dedicated footwear for use at the facility.

• Hand-sanitizer units outside fish and lettuce production areas and outside processing areas.

• Properly constructed and main-tained restrooms.

• Regular grass and brush removal on-site to decrease the number of pests in the environment, including birds, and rodents.

• Removal of standing water (in-sects).

• Garbage removed from site at least weekly. Garbage receptacles are covered and the area around them kept clean.

• Fish processing waste is covered and refrigerated until disposed of.


69


• Water used for plant and fish production meets appropriate water quality standards.

• Water is contaminated.

• No assurance that water meets required standards for its intended purpose.

• Compliance with agricultural water provisions in Produce Safety Rule, including testing provisions.

• Water used to raise fish is safe and not a source of contamination for either the fish or plants.

• The water used for hand-washing, produce-washing, fish-washing, contact surfaces, etc., should be potable and for processing activities, sanitized, and at proper temperature.

• No potable water is available.

• No hot water available for hand-washing in restrooms..

• No regular water testing conducted.

• Water not properly sanitized.

• Ice not made from potable water.

• Water testing not conducted at appropriate frequency.

• Water testing conducted using an inappropriate method.

• Water sampling done improperly or at less than necessary frequency.

• Potable water is available.

• Hot water is available

• Regular tests performed for E. coli, coliform, Listeria monocytogenes, pH, alkalinity, ammonia, nitrite, nitrate, and arsenic (important in areas where background levels are high).

• Regular worker training for personal hygiene, food handling, food processing, fish feeding, plant growth requirements, water recirculation systems, food defense, and biosecurity.

• No regular training is available.

• Training is not effective.

• Training not documented.

• Workers trained for skills needed in their job description.

• Training is effective.

• Training is documented.

• Training refresher provided at least once a year.

• Rest area for workers with appropriate lockers for storing personal items; lunchroom/breakroom provided.

• Convenient place to hang work clothes provided so work clothes are not taken out of processing area.

• Discourage prescription or OTC drugs, tobacco, and allergenic foods from being brought on-site.

• No designated lunchroom, rest area, lockers.

• Workers wear work clothes (coats, hats, aprons, boots, gloves) into toilet area, breakroom, or outside; no place to hang or store their clothing or personal protection equipment prior to using toilet.

• Personal items stored in processing or production areas.

• Prohibited substances on-site.

• Prohibited substances in production area.

• Well-designed rest area, lunchroom, and lockers that are convenient and easy to use.

• Sufficient storage for personal items.

• Sufficient storage for work clothing and personal protection equipment.

• Consumption of allergen-containing foods on-site is discouraged; if these foods are consumed, workers take decontamination precautions prior to returning to work (proper hand-washing should be sufficient).

• No prohibited substances on-site.


70


• Restroom for men and women provided outside of the production and processing area but easily accessible with potable hot and cold water, sanitizers, and required materials for maintaining a sanitary toilet area.

• Area to hang work clothes outside toilet area provided.

• Restrooms and rest areas are kept clean.

• Restroom inside the production or processing areas serving as a possible source of contamination.

• Restroom not properly constructed, serving as a potential source of contamination.

• No place to hang uniforms, boots prior to use of toilet.

• No clean uniforms or boots provided for workers to change into.

• No clean water, sanitizer, towels, etc.

• Restrooms not clean or well-maintained.

• Restroom located outside the production building.

• Hot and cold water, sanitizers, and clean stuffs are available.

• Routine cleaning schedule followed.

• SOPs are available for workers.

• Restrooms are well-maintained and stocked with clean paper towels.

• Uniforms and footwear are properly stocked and cleaned.

• Work clothes are properly stored.


71


• Aquaculture facility: tanks, plumbing, lighting.

• Workers not trained to operate pumps and plumbing system.

• Water quality is not adequate.

• Water testing not conducted or test results not available.

• Effective SOPs for cleaning tanks and plumbing system, and use of sanitizer, as needed, are not implemented.

• Design does not provide a means to isolate individual production tanks.

• Maintenance inadequate.

• Calibration or operation of testing equipment for water quality inadequate.

• UV or ozone systems used for water sanitization are not functioning, do not control microbial growth, or are not being operated or maintained properly.

• Workers are trained on operation of aquaculture system, and training is documented.

• Water quality testing (pH, T, dissolved oxygen, alkalinity, ammonia, nitrite, nitrate) is conducted.

• Test equipment is operational and properly calibrated.

• Effective SOPs are developed and implemented for cleaning aquaculture facility.

• System has been redesigned and reconstructed so tanks can be isolated from the system for disease control or for sanitizing individual tanks.

• Appropriate maintenance schedule developed and implemented.

• Appropriate cleaning schedule developed and implemented.

• Adequate ventilation to reduce risk of environmental microbe growth.

• Proper lighting with bulbs that are protected against breakage.

• UV or ozone systems are functioning and providing adequate sanitation.

• Effectiveness of UV and ozone systems checked at least weekly.

• Ozone concentration tested daily with a calibrated liquid ozone meter.

• UV lamp output checked weekly; assembly checked for fouling and cleaned as needed.


72


• Aquaculture feeding system. • No certificate of analysis on feed or inadequate ingredient statement.

• Improper on-site formulation of diets.

• Improper diet purchased.

• No medicated feed permissible in facility, but medicated feed found on-site.

• Improper feed storage in an open area, or in a building with improper ventilation and temperature control.

• Improper feed use, feed particle size, or feeding rate.

• Improper allergen segregation or unique allergens on-site for which there is no control program.

• Workers do not maintain proper hygiene during feed handling or feeding operations.

• Improper use of automatic feeders, clogged or empty feeders.

• Failure to clean and/or maintain feeding system.

• Workers lack knowledge of fish feed requirements and fish behavior.

• Improper pest control.

• Feed storage not segregated from rest of operation (allergens) or is not secured (food defense).

• Inventory of feed use inadequate.

• Medicated feeds on site.

• No control program.

• Feed shipment lacking proper documentation is rejected.

• Nonconforming feed is segregated and evaluated for safety. Rework if possible. Workers retrained on proper feed production techniques.

• No medicated feed at facility.

• Workers trained to use proper hygiene; and training is documented and annual updates are provided.

• Workers trained on allergen and security risks associated with feeds.

• Feed stored in a way to reduce risk of pest contamination and at proper temperature with adequate ventilation.

• Allergen control program in place so that feeds with unique allergens are segregated, properly stored, and inventoried.

• Recalculate the mass balance of fish. Workers observe fish behavior to see if they are consuming feed. Feeding rate is adjusted based on the amount of uneaten feed in the system.

• Proper particle size for the size of fish is used, based on feed manufacturer’s recommendations.

• Automatic feeders are cleaned, properly filled, and maintained.

• Smaller fish are fed by hand using best hygiene practices.

• Workers trained on what behavioral features to observe in fish to determine satiety and signs of stress.

• Effective SOPs for pest control are followed.


73


• Aquaculture feeding system. • No certificate of analysis on feed or inadequate ingredient statement.

• Improper on-site formulation of diets.

• Improper diet purchased.

• No medicated feed permissible in facility, but medicated feed found on-site.

• Improper feed storage in an open area, or in a building with improper ventilation and temperature control.

• Improper feed use, feed particle size, or feeding rate.

• Improper allergen segregation or unique allergens on-site for which there is no control program.

• Workers do not maintain proper hygiene during feed handling or feeding operations.

• Improper use of automatic feeders, clogged or empty feeders.

• Failure to clean and/or maintain feeding system.

• Workers lack knowledge of fish feed requirements and fish behavior.

• Improper pest control.

• Feed storage not segregated from rest of operation (allergens) or is not secured (food defense).

• Inventory of feed use inadequate.

• Medicated feeds on site.

• No control program.

• Feed shipment lacking proper documentation is rejected.

• Nonconforming feed is segregated and evaluated for safety. Rework if possible. Workers retrained on proper feed production techniques.

• No medicated feed at facility.

• Workers trained to use proper hygiene; and training is documented and annual updates are provided.

• Workers trained on allergen and security risks associated with feeds.

• Feed stored in a way to reduce risk of pest contamination and at proper temperature with adequate ventilation.

• Allergen control program in place so that feeds with unique allergens are segregated, properly stored, and inventoried.

• Recalculate the mass balance of fish. Workers observe fish behavior to see if they are consuming feed. Feeding rate is adjusted based on the amount of uneaten feed in the system.

• Proper particle size for the size of fish is used, based on feed manufacturer’s recommendations.

• Automatic feeders are cleaned, properly filled, and maintained.

• Smaller fish are fed by hand using best hygiene practices.

• Workers trained on what behavioral features to observe in fish to determine satiety and signs of stress.

• Effective SOPs for pest control are followed.


• Aquaculture unit biofilter. • Dead fish in water.

• No microbial lab test for water.

• No water quality test (T, pH, ammonia, nitrite, nitrate, dissolved oxygen) is available.

• Biofilters are clogged and not working efficiently.

• Water level too high and overflowing biofilter.

• Dead fish are removed from water as soon as possible.

• Portable device is available for water quality measurements.

• Regular water sampling and microbial testing is conducted.

• Biofilters are checked regularly for clogs, and any solid materials are removed.

• Filter is checked for damage or signs that removal of solid materials is not as effective as necessary.

• Pump for biofilter system properly maintained.

• Solid removal: Solids from fish tanks include fish fecal matter and leftover feed, which can be sources of cross-contamination (allergens) or microbial contamination.

• Clogged or torn filter cannot remove the solids effectively.

• No SOPs for removing the solids from the plant.

• No regular inspection of filters.

• No effective maintenance program.

• Lack of proper storage of recovered solids and use or disposal.

• Solid removal filters inspected daily.

• Solid waste is consistently removed from the fish production unit.

• Effective, operational SOPs, and maintenance program are in place.

• Recovery and the removal of solids removed.


74


• Plant germination and grow-out units, and water for this system.

• No microbial and chemical water testing results are available; improper level of testing.

• Water is in contact with the edible part of the plant and is not of appropriate microbial quality.

• No SOPs for germination, grow out, and harvesting.

• No training for employees.

• No effective program for cleaning and maintaining culture units.

• Insufficient phytosanitary program in place to reduce risk of plant disease.

• UV or ozone systems are not functional or not operated properly.

• UV output or ozone concentration not measured or measurements are not reliable.

• Regular water tests conducted for pathogens and indicator organisms.

• Regular water tests conducted for ammonia, nitrite, nitrate, pH, phosphorous.

• Water does not touch the edible part of the plant.

• SOPs available for germination, growing, and harvesting plants.

• Employee trained for handling rafts and harvesting plants.

• Hydroponic system design is appropriate for easy access, removal of rafts, and low risk of contamination during harvesting operations.

• Rafts inspected for damage.

• Rafts cleaned and sanitized.

• Germination and grow-out tanks cleaned at appropriate intervals to reduce biofilm formation.

• Proper ventilation reduces risk of microbial growth.

• Proper lighting with bulbs protected from breakage.

• SOPs for cleaning the facility.

• GMPs for maintaining operation, water flow, quality, and conditions for plant growth.

• UV and ozone systems are functioning as needed, with appropriate level of sanitization.

• UV and ozone systems are properly calibrated at appropriate intervals and calibrations recorded.


75


• Cross-contamination: microbes or allergens.

• No training available: microbes, allergens.

• No gloves, sanitizers, hand-washing/sanitizing stations or foot dips are available.

• Poor physical isolation between aquaculture unit and plant grow-out site.

• Facility lacks access controls to reduce risk of intentional contamination.

• Well-documented and routine training is provided for employees.

• Appropriate isolation exists between aquaculture and plant germination and grow-out units. These operations are in separate buildings. Access is controlled into the separate buildings.

• Boot and hand sanitizer stations are available.

• Gloves are available, along with hand-washing stations.

• Workers trained on use of hand and foot washing/sanitizing facilities.

• Facility access is restricted to authorized individuals only.

• No personal items are brought into production area.

• No chemicals stored in processing area, and chemical inventory is tightly monitored and controlled.

• Equipment and utensils. • Production equipment is rusty, broken, cracked, greasy, leaking, etc.

• Production equipment is unsanitary.

• Utensils are unsanitary.

• Utensils are not stored to protect them from contamination.

• Good maintenance program insti-tuted as part of GMPs.

• Effective sanitation SOPs in place. • Broken, rusty, and leaking parts

are replaced; food-grade oils and lubricants are used; the use of metals is controlled, including screw and staples.

• Harvesting methods to reduce risk of cross-contamination.

• No training for workers.

• No sanitation equipment for harvesting tools.

• No protective gloves or clothing for harvesting.

• Cross-contamination from water, hands, ice (if used), utensils, or other food contact surfaces.

• Workers trained in produce safety; training is documented.

• Sanitation equipment provided for tools; workers trained to maintain equipment in a sanitary state.

• Workers wear protective gloves and have clean uniforms.

• Good GMPs ensure no cross-contamination from water to food crop.


76


• Fish harvesting. • No clean totes or containers available.

• No SOPs for harvesting and handling fish.

• No cooling system or sanitary ice for harvested fish.

• Food-grade gas not available for live hauling.

• Hauling or brailing systems not sanitary.

• Fish are not secure from contamination during brailing or transport.

• Clean boxes or totes for harvesting fish are available and properly stored.

• SOPs are in place for harvesting and handling fish, including worker training.

• Ice available for cooling fish; mechanical refrigeration is functioning and adequate.

• Food-grade oxygen or air is available for live hauls; tanks are clean; tanks are secured.

• Brailing systems are kept sanitary; there is controlled access to brailing systems.

• Lettuce harvesting. • Workers handling plants with no hand protection.

• Workers lack clean clothing, head coverings, and footwear.

• Workers handling rafts and plants during harvesting without proper sanitary procedures.

• Knives and other utensils are not clean.

• Storage for knives and utensils inadequate.

• Harvest containers made of improper material or not clean.

• Workers wear clean gloves and clothing all the time.

• Workers have clean clothing, head coverings, and footwear.

• Workers only handle plants during the harvesting operation and not at other times; handling follows GMPs.

• Individuals trained in horticulture and plant health evaluate plants daily. Plants that need to be removed for further examination are handled in a sanitary manner.

• Utensils and food contact surfaces are made of suitable food-grade material and are in good repair, clean, and sanitary.

• Storage for knives and utensils is sanitary and protects workers from inadvertent injury.


77


• Lettuce washing, packaging, and storage.

• No lab test available for water.

• No on-site test available for chlorine.

• No SOPs for sanitizing the contact surfaces.

• No environmental sampling or tests.

• No cold storage available.

• No label.

• No allergen warning.

• No lot code or traceability.

• No tamper-evident feature with packaging.

• Transport vehicle unsuitable or dirty.

• Routine water sampling and tests conducted.

• Calibrated test kit for chlorine is on-site.

• SOPs in place for sanitizing the contact surfaces.

• Environmental sampling and tests conducted.

• Cold storage exists that is different from fish cold storage.

• Proper labeling for identification of product, storage conditions, allergen warning, traceability, and evidence of tampering.

• Storage area refrigerated, clean, and sanitary.

• Ice (if used) is clean and sanitary.

• Water is tested, potable, and contains chlorine at level to control microbial growth during wash step.

• Food contact surfaces are of durable, food-grade, cleanable material and are kept clean and sanitary.

• Environmental sampling conducted for ready-to-eat food; test results recorded, and product call-back program is in place if an issue is found with pathogenic microbes.

• Product traceability. • No records and lot number for shipment.

• Proper tracking system for tracking the products through the value chain.


78


• Chemicals. • No SOPs available.

• No MSDS available.

• Improper storage of chemicals.

• Improper containers and containment for chemicals in use.

• Chemicals (bulk) stored in production or processing area.

• No spill plan.

• Use of antibiotics; animal drugs prohibited.

• No training program for workers who make, use, or are exposed to chemicals. No documentation of worker training.

• SOPs are available.

• MSDS is available.

• Proper storage (toxic chemicals in locker).

• Inventory of chemicals is available.

•Third-party sanitizer provider (plastic containers with lock, on the wall).

• SOPs for spills and spill plan are available.

• Workers trained to handle, test, use, and store chemicals properly.

• Only enough chemicals needed for immediate use is in production or processing areas.

• No unapproved chemicals are on-site.

• Recall program. • No recall program and no mock recalls conducted.

• Recall team members and roles not noted or out of date.

• Contact information for regulatory agencies missing or inaccurate.

• Recall plan not integrated into overall crisis management program.

• No crisis management program.

• Well-written recall program in place, and mock recall held at least once a year.

• Recall members identified and trained, and their contact information kept up to date.

• List of key contacts is in place, including contacts for regulatory authorities. One person is tasked with keeping this list up to date and reviewing quarterly.

• Crisis management plan in place. (This is in addition to food defense plan.) Plan is exercised at least annually.


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AcknowledgmentsThis work was supported by the USDA National Institute of Food and Agriculture, Western Regional Center to Enhance Food Safety (USDA NIFA 2015-70020-24398). The authors would like to express their sincere thanks to Dr. Michael Schwarz, Director of Seafood AREC at Virginia Tech. for technical support; Gail Jamison, Seafood AREC, at Virginia Tech. for reviewing the document; and Dr. Nitin Nitin, Professor in the Department of Food Science and Technology/Biological Systems Engineering at UC Davis for his support. The authors would like to thank Amber Nair, Jacob Reynolds, Kate Allen, Estefania Fernandez, Rachael Kozolup, Theresa Klaman, Diane Ducharme, Stelios Viazis, Stephen Hughes, and Brandi McGrady, Food and Drug Administration; Jill Wisehart, Beth Lorence, Lyndsie Wilson, Karen Ullmann, Roger Beekman, and Kelly Hamilton, Washington State Department of Agriculture; Avery Cromwell, California Department of Food and Agriculture; Barbara Hanson, Alaska Department of Environmental Conservation; Angie Nelson, Montana Department of Agriculture; Cristy Dice, Colorado Department of Agriculture; Brian Daily, Rachel Clarke, Rebecca Mills, Ariel Agenbroad, Colette DePhelps, Gregg Small, and Jang Ho Kim, University of Idaho; Bruce Odegaard, Seafood Products Association; Jaclyn Evans and Brigitta Gruenberg, Idaho State Department of Agriculture; Daniel Perpich, Vertical Harvest Hydroponic; Dan Herman, Agribusiness Group, Virginia Department of Corrections; Lindsey Webb, U.S. House of Representatives; Tim Ham, and Stephanie Smith, Washington State University; Donn Sharp, U.S. Global Resources; Ron Johnson and John Colt, National Oceanic and Atmospheric Administration; and Torbjørn Trondsen, University of Tromsø; for their input and discussion during the workshops where this plan was presented and discussed.

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Documents

Green Aquaponics LLC as a ModelDecoupled aquaponic process flow diagram. A Guide to the Aquaponics Food Safety Plan Development: Green Aquaponics LLC as a Model. 2 Table 1. Product