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HACCP Plan Products: Cold Pressed Hemp Seeds Page 1 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES Selected Sections of a HACCP Plan For Cold Pressed Hemp Seeds Reviewed by: ________________________ Plant Manger Date: _______________________ Products: Cold Pressed Hemp Seeds Page 2 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES Table of Contents Company Overview ................................................................................................................................. 3 Product Description ................................................................................................................................. 4 Product Description ................................................................................................................................. 5 Flow Diagram .......................................................................................................................................... 6 Process Narrative .................................................................................................................................... 7 Ingredients and Packaging Material ..................................................................................................... 7 Receive Hemp Grain ............................................................................................................................ 7 Receive Packaging ............................................................................................................................... 7 Store Hemp Grain ................................................................................................................................ 7 Store Packaging ................................................................................................................................... 7 Clean Hemp Grain................................................................................................................................ 7 Auger Clean Grain from Outdoor Hopper to Indoor Hopper ................................................................. 7 KK40 Screw Pressing ............................................................................................................................ 8 Hemp Seed Oil ..................................................................................................................................... 8 Filtering/Pump .................................................................................................................................... 8 Filling (5-gallon pails, 55-gallon drum).................................................................................................. 8 Store, Ship ........................................................................................................................................... 8 Hemp Seed Cake.................................................................................................................................. 8 Milling ................................................................................................................................................. 9 Sifting .................................................................................................................................................. 9 Metal Detection .................................................................................................................................. 9 55-Gallon Drum ....................................................................................................................................... 9 Filling (20lb sacs) ................................................................................................................................. 9 Store, Ship ........................................................................................................................................... 9 Hazard Analysis ..................................................................................................................................... 10 Process Preventative Control ................................................................................................................. 15 Allergen Preventive Controls ................................................................................................................. 15 Ingredient Allergen Identification ...................................................................................................... 15 Production Line Allergen Assessment ................................................................................................ 16 Products: Cold Pressed Hemp Seeds Page 3 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES Scheduling Implications: .................................................................................................................... 16 Allergen Cleaning Implications: (Required)......................................................................................... 16 Sanitation Preventive Controls .............................................................................................................. 16 Zoning and Related GMP Controls ..................................................................................................... 16 Cleaning and Sanitation ..................................................................................................................... 16 Microbiological Verification of Sanitation Practices ............................................................................ 17 Supply-chain-applied Preventive Controls Program ............................................................................... 17 Company Overview Hemp Acres is a small processing facility that makes a variety of consumable products from locally grown industrial hemp seeds and flower. The manufacturing process begins by cleaning the grain of any foreign seeds and debris to a level of 99.9% pure hemp seed. Once clean, the grain is then fed i nto a screw press, where the oil is extruded from the hemp seed. The grain being fed through the press exceeds 140℉, ensuring a kill step. After passing through the press, the oil separates from the seed, collected and passes through a filtration process. The hemp meal (cake) is milled and sifted to collect the protein powder. • Seed Cleaning (described in this plan) • Hemp Seed Oil (described in this plan) • Hemp Protein Powder (described in this plan) The hemp seed oil and protein powder are made 5 days a week in one 5-hour production shift, followed by 3 hours of sanitation. Dry cleaning is used in production area, with select pieces of equipment being cleaned in a three-compartment sink, or sanitized and washed down in place. Water is treated and tested per EPA requirements by the county. An integrated pest control program is also in place. Products: Cold Pressed Hemp Seeds Page 4 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES Product Description Product Name Hemp Seed Oil Product Description, Including Important Food Safety Characteristics This product is a ready to eat oil, bottled in 12floz glass amber bottles, 1-gallon jugs, 5-gallon pals, or 55-gallon drums. During the filtering process diatomaceous earth and bleaching clays are added to filter and refined for a more stable product shelf life. Ingredients Hemp Seed Packaging Used Glass, 12floz individual retail package with label Plastic, food grade 1-gallon, 5-gallon pail, 55- gallon food grade drum. Intended Use Ready to eat oil, bulk blending oil, cosmetic oil Intended Consumers General consumption, topical applications Shelf Life 18 months Labeling Instructions None Storage and Distribution Ambient, not to exceed 90℉, Keep refrigerated upon opening Approved: Signature: Print Name: Date: Products: Cold Pressed Hemp Seeds Page 5 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES Product Description Product Name Hemp Protein Powder Product Description, Including Important Food Safety Characteristics This product is ready to eat protein powder packed in 20lb sealed bags. The process involves milling the cake to a fine powder which then passes through a sifter, separating the protein from the fiber. The low water activity makes the product shelf stable. Water activity ≥0.65 Ingredients Hemp Seed Cake Packaging Used 20lb food safe bags Intended Use Ready-to-eat protein powder, protein bars, mix with smoothies etc. Intended Consumers General Consumption Shelf Life 10 Months Labeling Instructions None Storage and Distribution Ambient, not to exceed 90℉, keep in a cool dry place. Approved: Signature: Print name: Date: Products: Cold Pressed Hemp Seeds Page 6 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES Flow Diagram Receive hemp grain Store grain in 4000 bu. Hopper bin Clean grain to 99.9% pure with air screener and gravity table, filling smaller hopper Hemp Seed Cake Cake falls in trough and augured into cake hopper Hemp Seed Oil Oil falls into trough and into 1st Mixing Tank Pump/Filter Auger clean grain from outside hopper to inside hopper KK40 grain screw press +140℉ 2nd Mixing Tank Clean oil tank Cake is augured up to mill Milling Sifting Metal detection 55-galllon food bucket Filling, 25lb-50lb sacs Store, ship Filling, 55-gallon drums Filling, 5-gallon pails Store, ship Gray area indicates primary pathogen control area Receive Packaging Store Packaging 1-micron filter CCP1 PCC 1 CCP2 PCC 2 Products: Cold Pressed Hemp Seeds Page 7 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES Process Narrative Ingredients and Packaging Material Processing material is purchased from local farmers and delivered on site by farmer. Supplier that provide hemp grain have had their grain load sampled for microbial content by Minnesota Valley Testing Labs. Each delivery is administered a lot number to ensure traceability to the source of grain. Packaging material are purchased from an approved supplier that complies with internationally recognized food safety and quality systems. Receive Hemp Grain Hemp Grain – Received by the semi-load. Unloading of the hemp grain is transferred from the semi-truck via Hemp Acres grain vacuum, and blown into 4000bu. Hopper bin. A lot number is assigned with each delivery and a copy is given to both Hemp Acres and the deliverer. Receive Packaging Bags and bottles are delivered in bulk to the facility. Suppliers provide a certificate of conformance that packaging materials and inks meet food safety and regulatory requirements. Store Hemp Grain Ingredients are comprised only of raw hemp seed. Once processed the ingredients are stored in the facility (temperature kept below 70℉). All containers are sealed to avoid cross-contact and cross- contamination during storage. Store Packaging Buckets, bottles, and sacs are stored in a dry dedicated space within the facility. Packaging is used First- In-First-Out. Clean Hemp Grain Grain is augured form 4000 bu. Hopper bin to air screener. The grain falls onto two screens with specific slotted holes to size the grain and remove foreign seeds. Air is applied to both the top screen and bottom screen to blow off debris. The grain falls out the clean shoot and into a 13’ elevator leg. The elevator lifts the grain, unloading into the gravity table. The gravity table uses more air and screening to remove any seeds that aren’t hemp and remove immature/undesirable seeds. The clean shoot from the gravity table is now 99.9% pure hemp seed (an acceptable level to process) and is dispensed into a 22’ elevator leg. This leg unloads the cleaned grain into a 3.5-ton bulk hopper tank, which holds clean grain ready to be processed. Auger Clean Grain from Outdoor Hopper to Indoor Hopper Grain is augured from outside hopper to indoor hopper. The indoor hopper gravity feeds the presses, removing the oil from the seed. Products: Cold Pressed Hemp Seeds Page 8 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES KK40 Screw Pressing Heat sleeves are applied to the screw press to raise the temperature of the barrels to 200℉. This warms the barrels allowing for the seed to begin crushing. The press is adjusted accordingly to allow for the maximum amount of oil to be squeezed from the seed. The press heads stay a constant temperature above 140℉ and under intense pressure, ensuring a kill step at this point. Once the press is set, it runs untouched until 300L oil tank is full. Hemp Seed Oil There are two troughs that separate the oil from the cake. The oil collects and flows from the trough into a 300L stainless steel tank. A substantial amount of sediment from the press falls into the tank as well, which is a crucial part of the filtering process. Filtering/Pump Once the desired amount of oil is collected in the dirty oil tank, the press is shut down so filtering can commence. A ratio mixture of Diatomaceous Earth (DE) is added to the oil and a stirrer is turned on to agitate the sediment and DE together. Once a desired mixture is achieved, the oil is pumped through a screening plate filter under pressure. This process circulates the oil through the filter, back into the dirty oil tank. After about 1 hour of running, the DE and sediment have filtered the oil ≤ 1 micron, and the oil is pumped into the 2nd mixing tank. Now the sediment is removed from the filter frames and cleaned. The oil will go through one more step to remove the chlorophyll and any heavy metals which will ensure stability of the oil. With the stirrer activated, Bleaching Clays (BE) and DE are added back into the dirty oil tank. Once the desired mixture is set, the pump is turned on, moving the oil back through the filter for about 1 hour (or until desired levels of purity are met). Once the oil meets our set standards, a bypass valve is opened, passing through a 1-micron filter, filling a 300L stainless steel tank, or 55-gallon drum, with clean oil. Filling (5-gallon pails, 55-gallon drum) The identity of the 5-gallon pail or 55-gallon drum is confirmed for each batch placed on the line to ensure that it is the correct material and proper SKU #. 5-gallon buckets are filled directly by hand from the 300L clean oil tank. 55-gallon drums are filled directly from a filling hose off the 1-micron filter. Once filled they are moved down the line to be capped, sealed, and labeled for completion. Store, Ship Jugs, pails, and drums are stored in a designated area in the facility or shipped out immediately upon customers’ requests. Hemp Seed Cake The cake is extruded hot off the press and falls into a designated “cake trough”. In this trough is a slow- moving stainless-steel auger which conveys the cake into a designated “cake hopper”, cooling it along the way. Once to the end of the trough, the cake falls into the hopper and awaits milling. Products: Cold Pressed Hemp Seeds Page 9 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES Milling Connected to the cake hopper is a stainless-steel flighting auger. Once this flighting auger is initiated, the caked travels up to 13’, unloading into a grinder. This grinder spins at high rpm’s, pulverizing the cake into a fine powder and passes through a screen. Sifting In one fluid motion, the pulverized cake falls from the grinder, through food grade tubing, and onto a sifting screener. The sifter is aggressively vibrating, allowing for finer particles (protein) to fall through, while leaving the larger particles (fiber) on top of the screen. The two particles exit the screen through spouts and fall through more food grade tubing. Critical control point to ensure no metal can pass through a .35mm screen. Metal Detection As the protein exits the sifter, it falls through a food grade tube which passes through a calibrated metal detector. This ensures no metal is ending up in the sifted protein. 55-Gallon Drum As the protein falls through the metal detector, we fill 55-gallon drums at a time to ensure no metal shavings are in the final protein sacs. Filling (20lb sacs) When the 55-gallon drum is close to being full, it is transferred out with a new drum. We then scoop from the 55-gallon bucket into 20lb food grade bags for wholesale. Sacs are sealed, dated, labeled, and ready for shipment. Store, Ship Sacs are stored in a designated area within the facility or shipped out immediately upon customers’ requests. Products: Cold Pressed Hemp Seeds Page 10 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES Hazard Analysis Hazard identification (column 2) considers those that may be present in the food because the hazard occurs naturally, the hazard may be unintentionally introduced, or the hazard may be intentionally introduced for economic gain. B= Biological hazards including bacteria, viruses, parasites, and environmental pathogens. C= Chemical hazards, including radiological hazards, food allergens, substances such as pesticides and drug residues, natural toxins, decomposition, and unapproved food or color additives. P= Physical hazards include potentially harmful extraneous matter that may cause choking, injury or other adverse health effects. (1) Ingredient or Processing Step (2) Identify potential food safety hazards introduced, controlled or enhanced at this step (3) Are any potential food safety hazards requiring a preventive control? (4) Justify your decision for column 3 (5) What preventive control measures can be applied to significantly minimize or prevent the food safety hazards? Process including CCP’s Allergen, Sanitation, Supply-chain, other preventive control (6) Is the preventive control applied in this step? Yes No Yes No Receive Packaging: 12floz glass bottles,5-gal pails, 55-gal drum, 20lb sacs B None C None P None Store Packaging B None C None P None Receive Hemp Grain B None X Grain is automated vacuum system. All shipments of grain undergo 3rd party analysis prior to delivery to ensure grain X Products: Cold Pressed Hemp Seeds Page 11 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES meets certain standards. C Gluten X Grain undergoes Gluten testing before delivery 3rd party analysis. X P Foreign debris, metal, wood X Grain passes through multiple cleaning machines and magnets to ensure no foreign debris enters the facility Air Screener, Gravity Table, Magnets before entering press. X Store Hemp Grain B None X Grain is between 8%- 9% moisture The grain will ultimately enter the press which exceed 140℉, acting as a kill step X C None P None Clean Hemp Grain B None X Contamination possible if environment and employee practices not managed at appropriate hygiene level. Sanitation Control – Zoning, maintain dry environment, Cleaning equipment before operating and after shut down. X C None P Metal, wood, foreign debris X Contamination possible if delivery of grain has foreign debris. Applying air, screens of multiple sizes and magnetics ensure nothing but hemp enters the indoor hopper X Continued Products: Cold Pressed Hemp Seeds Page 12 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES Auger Clean Grain from Outdoor Hopper to Indoor Hopper B None X Cracking of seeds in auger, causes free fatty acids Monthly cleaning of the auger is preformed X C None P None KK40 Screw Press B None X Contamination possible if environment and employee practices not managed at appropriate hygiene level. Sanitation control – Zoning, maintaining dry environment X C None P None Hemp Seed Oil B None X Contamination possible if environment and employee practices not managed at appropriate hygiene level. Sanitation control – Zoning, maintaining dry environment. Cleaning before and after each batch. X C None P None Filtering/Pump B None X Contamination possible if environment and employee practices not managed at appropriate hygiene level. Sanitation control – Zoning, maintaining dry environment. Cleaning before and after each batch. X C Minerals from DE and BE X Diatomaceous Earth and Bleaching clays are Bleaching clay remove chlorophyll which provides stability X Products: Cold Pressed Hemp Seeds Page 13 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES natural occurring food safe minerals used as filter aid. P None Filling (5-gallon, 55- gallon drums) B None X Contamination possible if environment and employee practices not managed at appropriate hygiene level. Sanitation control – Zoning, maintaining dry environment. Cleaning before and after each batch. X C None P None Store, Ship B None C None P None Hemp Seed Cake B None X Contamination possible if environment and employee practices not managed at appropriate hygiene level. Sanitation control – Zoning, maintaining dry environment. Cleaning before and after each batch. X C None P None Continued Products: Cold Pressed Hemp Seeds Page 14 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES Milling Yes No Yes No B None X Contamination possible if environment and employee practices not managed at appropriate hygiene level. Sanitation control – Zoning, maintaining dry environment. Cleaning before and after each batch. X C None P Metal X Poorly maintained or ware on mill could generate metal fragments passing through the screen. Subsequent Metal Detection X Sifting B None X Contamination possible if environment and employee practices not managed at appropriate hygiene level. Sanitation control – Zoning, maintaining dry environment. Cleaning before and after each batch. X C None P None Metal Detection B None C None P Metal Inclusion X Metal may be present from previous operation Process control – metal detector X 55-gallon Drum B None X Contamination possible if environment and employee practices not Sanitation control – Zoning, maintaining dry environment. Cleaning before X Products: Cold Pressed Hemp Seeds Page 15 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES managed at appropriate hygiene level. and after each batch. C None P None Filling 20-lb Sacs B None X Contamination possible if environment and employee practices not managed at appropriate hygiene level. Sanitation control – Zoning, maintaining dry environment. Cleaning before and after each batch. X C None P None Store, Ship B None C None P None Process Preventative Control Allergen Preventive Controls Ingredient Allergen Identification Raw Material Name Supplier Allergens in Ingredient Formulation Allergens in Precautionary Labeling Egg Milk Soy Wheat Tree Nut Peanut Shellfish Process Control Hazards Critical Limits Monitoring Corrective Action Verification Record What How Frequency Who Metal Detectio n Metal Inclusio n Alarm/L ight Fall through Constant Plant Mana ger Rerun Signature per batch Per Batch Filtering Sedimen t Inclusio n % of DE & BE Mix Incorporat e measured amounts into dirty oil tank Per Batch Plant Mana ger Sample testing Signature per batch Per Batch Products: Cold Pressed Hemp Seeds Page 16 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES Hemp Grain Local Organic Famers None Production Line Allergen Assessment Product Name Production Line Intentional Allergens Egg Milk Soy Wheat Tree Nut Peanut Fish Shellfish Hemp Grain 1 Scheduling Implications: Hemp grain is hypoallergenic; therefore, no risk is currently present in the processing of hemp grain. Allergen Cleaning Implications: (Required) Allergen cleaning is unnecessary due to the fact we only deal with the hemp grain which is hypoallergenic. Sanitation Preventive Controls Zoning and Related GMP Controls The processing areas are maintained at a higher hygiene level than receiving, storage, and shipping area, as specified in SOP 15-123 – High Hygiene Sanitation Procedures. As specified in SOP 15-456 – Employee Hygiene in High Hygiene Areas, employees must put on smocks that do not have pockets, change into factory shows, put on protective equipment (hair net, beard net), and wash their hands before entering processing and production area. Filling area is maintained at the same hygiene level as the processing area (See SOP 15-789 – Filling Procedures). Equipment and utensils that are cleaned out-of-place are cleaned and sanitized in a wash area adjacent to the processing area. Clean equipment is dried and stored on tables and racks in an area adjacent to the processing area. Cleaning a sanitation equipment has a dedicated location to store sanitation and cleaning equipment. Cleaning and Sanitation The facility, including loading areas are dry cleaned. Processing area, and storage area are maintained dry during production. Lines and equipment are wet cleaned and sanitized before each new batch of processing begins. Equipment is completely dried prior to production. See these Standard Operating Procedures for details. • SOP 16-454 – Dry Cleaning Products: Cold Pressed Hemp Seeds Page 17 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES • SOP 16-455 – Controlled Wet Cleaning Microbiological Verification of Sanitation Practices A Salmonella environmental monitoring program is in place to verify that controls are sufficient to prevent the presence and harborage of Salmonella in the environment and equipment. This program includes an evaluation of Enterobacteriaceae levels as an additional verification that conditions do not exist that could lead to the presence and harborage of Salmonella. Enterobacteriaceae environmental monitoring occurs weekly and Salmonella monitoring occurs monthly. Additional environmental monitoring is conducted in the event of special circumstances, including equipment maintenance in processing area. Leaks that could occurring in the oil processing that could introduce free fatty acids to oils and proteins. See: • SOP 15-282: Environmental Monitoring Verification Procedures • SOP 15-283: Environmental Monitoring for Special Circumstances Supply-chain-applied Preventive Controls Program We work directly with farmers to provide us with hemp grain that meets certain specifications. Prior to delivery, farmers are required to third party analysis their grain for microbiological content of the grain. Raw Material or Ingredient Hemp Grain Approved Supplier Approval Date Hazards APC, Mold, Yeast, E. Coli, Salmonella, Mycotoxins, Gluten, Peroxide, Free Fatty Acids Preventive Controls Applied by the Supplier Proper harvest and storage of grain Type of Supplier Verification 3rd party analysis of homogenized sample taken from grain bin Verification Procedure A copy of a 3rd party analysis. Copy of field location of where grain was grown, how it was harvested, and stored. Records • Incoming goods log • 3rd party COA of grain • Bill of Lading verifying each shipment of grain • Lot numbers assigned to each incoming delivery of grain. • Corrective action records. • 2-year record keeping Products: Cold Pressed Hemp Seeds Page 18 of 18 Plant Name: Hemp Acres LLC ISSUE DATE 04/15/19 Address: 8420 County Road 10 E Waconia, MN 55387 SUPERSEDES