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Good Agricultural and Collection Practices and Good Manufacturing Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials GOOD AGRICULTURAL AND COLLECTION PRACTICES AND GOOD MANUFACTURING PRACTICES FOR BOTANICAL MATERIALS CONTAINS NONBINDING RECOMMENDATIONS March 2017 Prepared by the American Herbal Products Association This document is the property of the American Herbal Products Association (AHPA) and is for AHPA purposes only. Unless given prior approval from AHPA, it shall not be reproduced, circulated, or quoted, in whole or in part, outside of AHPA, its Committees, and its members. Cite as: American Herbal Products Association. March 2017. Good Agricultural and Collection Practices and Good Manufacturing Practices for © March 2017 Botanical Materials. 1 Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials Contents Contents ..........................................................................................................................ii Acknowledgements ......................................................................................................... vi Preface ............................................................................................................................ vi Introduction ................................................................................................................... vii Disclaimers ...................................................................................................................... xi DEFINITIONS ................................................................................................................... 1 1. D.1. Definitions ............................................................................................................ 1 BOTANICAL IDENTITY AND QUALITY ............................................................................ 10 2. BQ.1. Botanical identity and quality ......................................................................... 10 BQ.1.1. General considerations ................................................................................ 10 BQ.1.2. Identity ......................................................................................................... 11 BQ.1.3. Physical characteristics ................................................................................ 14 BQ.1.4. Chemical characteristics ............................................................................... 15 BQ.1.5. Contaminants ............................................................................................... 16 CULTIVATION ................................................................................................................ 18 3. C.1. Cultivation .......................................................................................................... 18 C.1.1. Propagation material ...................................................................................... 18 C.1.2. Cultivation site ................................................................................................ 19 C.1.3. Fertilizer use .................................................................................................... 22 C.1.4. Irrigation .......................................................................................................... 25 C.1.5. Crop maintenance and protection .................................................................. 26 C.1.6. Other considerations ...................................................................................... 28 WILD COLLECTION ........................................................................................................ 29 4. WC.1 Wild collection ................................................................................................. 29 WC.1.1. Permits and permissions ............................................................................. 29 WC.1.2. Collection site .............................................................................................. 30 WC.1.3. Sustainability ............................................................................................... 31 ii © March 2017 Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials WC.1.4. Identification ............................................................................................... 34 WC.1.5. Other considerations ................................................................................... 35 GENERAL FARM STANDARDS ....................................................................................... 37 5. GF.1 General farm standards .................................................................................... 37 GF.1.1. General considerations ................................................................................. 37 GF.1.2. Farm buildings .............................................................................................. 39 GF.1.3. Farm equipment ........................................................................................... 40 GF.1.4. Farm personnel ............................................................................................. 41 GF.1.5. Records ......................................................................................................... 42 HARVEST OF CULTIVATED AND WILD COLLECTED PLANTS .......................................... 43 6. H.1 Harvest of cultivated and wild collected plants ................................................. 43 H.1.1. Harvest conditions .......................................................................................... 43 H.1.2. Harvest quality ................................................................................................ 45 H.1.3. Harvest documentation and samples ............................................................. 46 POST-HARVEST HANDLING ........................................................................................... 49 7. PH.1 Post-harvest handling ....................................................................................... 49 PH.1.1. Handling immediately after harvest ............................................................. 49 PH.1.2. Separating the desired plant part ................................................................ 50 PH.1.3. Washing and cleaning ................................................................................... 50 PH.1.4. Dehydration .................................................................................................. 51 FURTHER PROCESSING AND HANDLING ...................................................................... 56 8. FP.1 Further processing and handling ....................................................................... 56 FP.1.1. Special preparation ....................................................................................... 56 FP.1.2. Size reduction ................................................................................................ 56 FP.1.3. Extraction ...................................................................................................... 58 FP.1.4. Packing, packaging, and storage ................................................................... 60 FP.1.5. Shipping ......................................................................................................... 63 FOOD FACILITY AND FARM MIXED-TYPE FACILITY REQUIREMENTS ............................ 65 9. FF.1 Food facility and farm mixed-type facility requirements .................................. 65 FF.1.1. Regulations .................................................................................................... 65 iii © March 2017 Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials FF.1.2. Personnel ....................................................................................................... 65 FF.1.3. Plant and grounds ......................................................................................... 67 FF.1.4. Sanitary operations ....................................................................................... 69 FF.1.5. Sanitary facilities and controls ...................................................................... 70 FF.1.6. Equipment and utensils ................................................................................. 72 RECOMMENDATIONS FOR DIETARY INGREDIENT PROCESSORS ................................. 74 10. DI.1 Recommendations for dietary ingredient processors ..................................... 74 DI.1.1. Regulations .................................................................................................... 74 DI.1.2. Component controls ...................................................................................... 75 DI.1.3. Processing operations and finished product controls ................................... 76 DI.1.4. Laboratory operations ................................................................................... 78 DI.1.5. Personnel ....................................................................................................... 79 DI.1.6. Equipment ..................................................................................................... 79 DI.1.7. Quality management ..................................................................................... 79 APPENDIX 1: COVERED PRODUCE SUBJECT TO PART 112 ........................................... 81 §112.1 What food is covered
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