U.S. Hemp Guidance Program

U.S. Hemp Guidance Program

U.S. Hemp Guidance Program DRAFT PHASE 2

TABLE OF CONTENTS

1 GROWER .......................................................................................................................................... 1 1.1 General Terms & Definitions............................................................................................................... 1 1.2 Registration/Application/Notification .................................................................................................. 3 1.2.1 Registration/Application Guidance............................................................................................. 3 1.2.2 Notification of Changes to the licensor by the licensee .......................................................... 3 1.3 Personnel............................................................................................................................................... 4 1.3.1 PERSONNEL GUIDANCE CHECKLIST................................................................................... 5 1.3.2 BEST MANAGEMENT PRACTICES CHECKLIST ................................................................. 6 1.3.3 FACILITY & BIOSECURITY AWARENESS CHECKLIST ..................................................... 7 1.4 Sampling and Handling Hemp for THC & CBD ............................................................................... 9 1.4.1 Definitions ...................................................................................................................................... 9 1.4.2 Sampling Timeline and Grower Responsibilities ................................................................... 10 1.4.3 Pre-Harvest Sampling Procedure ............................................................................................ 10 1.4.4 Handling Procedures of Pre-Harvest Samples ...................................................................... 10 1.4.5 Post-Harvest Sampling Procedures for Floral Material ........................................................ 10 1.4.6 Handling Procedures of Post-Harvest Samples .................................................................... 12 1.5 Testing and Hemp Cannabinoid Quantification: ............................................................................ 13 1.5.1 Potency ........................................................................................................................................ 13 1.5.2 Purity & Contaminants ............................................................................................................... 13 1.6 Storage and Distribution .................................................................................................................... 16 1.6.1 STORAGE & DISTRIBUTION CHECKLIST........................................................................... 17 1.7 Record Retention................................................................................................................................ 18 1.7.1 RECORD RETENTION CHECKLIST ...................................................................................... 19

2 PROCESSOR.................................................................................................................................. 20 2.1 General Terms & Definitions............................................................................................................. 20 2.2 Registration/Application/Notification ................................................................................................ 22 2.2.1 Registration/Application Guidance........................................................................................... 22 2.2.2 Notification of Changes to the licensor by the licensee ........................................................ 22 2.3 Personnel Guidance........................................................................................................................... 23 2.3.1 PERSONNEL CHECKLIST....................................................................................................... 24 2.4 Employee Training ............................................................................................................................. 25

U.S. Hemp Guidance Program DRAFT PHASE 2

2.4.1 NEW EMPLOYEE TRAINING CHECKLIST........................................................................... 27 2.4.2 EMPLOYEE TRAINING CHECKLIST/ANNUAL RECERTIFICATION............................... 32 2.5 Physical Plant and Grounds.............................................................................................................. 34 2.5.1 PHYSICAL PLANT AND GROUNDS CHECKLIST............................................................... 36 2.5.2 FACILITY & BIOSECURITY AWARENESS CHECKLIST ................................................... 37 2.6 Quality Management Systems.......................................................................................................... 39 2.6.1 QUALITY MANAGEMENT SYSTEMS CHECKLIST ............................................................ 42 2.6.2 QUALITY MANAGEMENT SYSTEMS PERSONNEL CHECKLIST................................... 43 2.6.3 LABORATORY OPERATIONS CHECKLIST......................................................................... 44 2.7 Industrial Hemp Guidance ? Supplier Qualification & Specifications ......................................... 45 2.8 Sampling and Handling Hemp for THC & CBD ............................................................................. 46 2.8.1 Definitions .................................................................................................................................... 46 2.8.2 Sampling Timeline and Grower Responsibilities ................................................................... 46 2.8.3 Pre-Harvest Sampling Procedure ............................................................................................ 47 2.8.4 Handling Procedures of Pre-Harvest Samples ...................................................................... 47 2.8.5 Post-Harvest Sampling Procedures for Floral Material ........................................................ 47 2.8.6 Handling Procedures of Post-Harvest Samples .................................................................... 48 2.9 Testing and Hemp Cannabinoid Quantification: ............................................................................ 49 2.9.1 Potency ........................................................................................................................................ 49 2.9.2 Purity & Contaminants ............................................................................................................... 49 2.10 Equipment and utensils ..................................................................................................................... 53 2.10.1 EQUIPMENT CHECKLIST........................................................................................................ 54 2.11 Production and Process Control ...................................................................................................... 55 2.11.1 PRODUCTION & PROCESS CONTROL CHECKLIST........................................................ 56 2.12 Production and Process Control Systems Master Manufacturing Record ................................ 57 2.12.1 PRODUCTION AND PROCESS CONTROL SYSTEMS MASTER MANUFACTURING RECORD ..................................................................................................................................................... 58 2.13 Packaging and Labeling Industrial Hemp ....................................................................................... 59 2.13.1 Labeling Practices ...................................................................................................................... 59 2.13.2 Guidance for packaging and labeling operations .................................................................. 59 2.13.3 Quality control procedures shall include: ................................................................................ 60 2.13.4 PACKAGING AND LABELING CHECKLIST ......................................................................... 61 2.14 Storage and Distribution .................................................................................................................... 62

U.S. Hemp Guidance Program DRAFT PHASE 2

2.14.1 STORAGE AND DISTRIBUTION CHECKLIST ..................................................................... 63 2.15 Quality Control Operations Related to Product Complaints, Adverse Events and Recalls..... 64

2.15.1 PRODUCT COMPLAINTS ADVERSE EVENTS, AND RECALLS CHECKLIST ............. 65 2.16 Import / Export..................................................................................................................................... 66

2.16.1 Import ........................................................................................................................................... 66 2.16.2 Export ........................................................................................................................................... 67 2.17 Record Retention................................................................................................................................ 68 2.17.1 RECORD RETENTION CHECKLIST ...................................................................................... 69

U.S. Hemp Guidance Program PHASE 2

1 GROWER

1.1 GENERAL TERMS & DEFINITIONS

The following Definitions and Interpretations apply to such terms when used in this U.S. Hemp Guidance Program.

Adulteration refers to a food that may be considered adulterated if it contains "any poisonous or deleterious substance which may render it injurious to health.....or if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is".

Batch means a specific quantity of industrial hemp that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified period of time according to a single manufacturing record.

Batch number, or lot number means any distinctive group of letters, or numbers, or any combination of them, from which the complete history of the processing, packaging, labeling, and/or storage of a batch or lot of industrial hemp product can be determined.

Biomass means the amount of living matter in a given habitat, expressed either as the weight of organisms per unit area or as the volume of organisms per unit volume of habitat.

Component means any substance intended for use in the manufacture of industrial hemp, including those that may not appear in the finished batch of the industrial hemp.

Growth Medium means the solid, liquid or semi-solid substance used to support the growth of the plant.

Hemp refers to cannabis varieties and any part of the plant, whether growing or not, containing a delta-9 tetrahydrocannabinol (THC) concentration of no more than three-tenths of one percent (0.3%) on a dry weight basis.

Industrial Hemp is Hemp

Ingredient means any substance that is used in the manufacture of hemp and that is intended to be present in the finished batch of the hemp product.

In-process material means any material that is compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any way for use in the manufacture of the hemp product.

Lot means a batch, or a specific identified portion of a batch, or, in the case of a hemp product produced by continuous process, a specific identified amount produced in a specified unit of time or

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