Hemp Products Rule West Virginia Department of Agriculture Public - PowerPoint PPT Presentation

61CSR30 Hemp Products Rule West Virginia Department of Agriculture Public Informational Meeting July 29, 2019

Authority – WV Code 19-12E-7  “…Production, sale, possession, handling, or transport of hemp products and extracts, including those containing one or more hemp- derived cannabinoids, including CBD”

Why regulate hemp products?  Public Safety  Consumer Protection  Industry Confidence

Hemp products Covered under 61CSR30 Not Covered Hemp seed derivates Hemp that has not been processed   Hemp concentrates or extracts Hemp that has been minimally processed   Hemp edibles Agricultural hemp seed   Hemp drinks  Hemp tinctures  Hemp lotions  Hemp transdermal patches  Hemp fiber products  Hemp seed incapable of germination  Hemp oil  Hemp aerosols  Hemp vaping products  Hemp pet treats 

THC Content  Per the 2018 Farm Bill section 297B (ii)  THC must be under 0.3%  Dry weight basis  Δ 9- THC post decarboxylation

Decarboxylation Non-psychoactive Psychoactive

What are other states doing? State Instrumentation Calculation Arkansas HPLC Δ9 THC + (THC -A * 0.877) California HPLC Δ9 THC + (THC -A * 0.877) Colorado GC/FID Δ9 THC + (THC -A * 0.877) Kentucky GC/FID Δ9 THC + (THC -A * 0.877) Maine HPLC Δ9 THC + (THC -A * 0.877) Minnesota HPLC Δ9 THC + (THC -A * 0.877) New Jersey HPLC Δ9 THC + (THC -A * 0.877) Nevada HPLC Δ9 THC + THC -A Oregon HPLC Δ9 THC + (THC -A * 0.877) South Carolina GC/FID & HPLC Δ9 THC + (THC -A * 0.877) Tennessee HPLC Δ9 THC Virginia GC/FID Δ9 THC + (THC -A * 0.877) Wisconsin HPLC Δ9 THC + (THC -A * 0.877) West Virginia HPLC Δ9 THC + (THC -A * 0.877)

What we do… Ultra-high-performance liquid chromatography (UHPLC) to  chromatographically separate and quantitate the THC and THC-A  %Total Δ9 - THC = % Δ9 -THC + (% Δ9 -THCA × 0.877)  Results are used to confirm the total THC concentration on a dry weight basis  Samples that have results above 0.3 total THC are retested in duplicate to confirm results.

Sellers & Distributors of Hemp Products  Required to register with the WVDA to sell or distribute hemp products and extracts in WV  Must fill out application form  $100 annual registration fee  Expires annually on December 31 st  Registration is required annually  Manufacturers who are only selling their own products are exempt from the $100 fee, but shall register  May add additional products throughout the year  Annual approved seller / distributor stickers

Manufacturer Requirements  Manufacturers who wish to sell hemp products in WV must register annually  Application form must be completed  Complete copy of label must be included  Certificate of Analysis (COA)  $200 fee per product  Hemp fiber products are exempt from fee  Product lot and traceability must be maintained by manufacturer

Certificate of Analysis  Lot  Date issued  Lab methods  Product Name  CBD content  THC content  Solvents  Pesticides  Microbial contaminants  Heavy Metals

Labeling Requirements FDA guidelines for food labeling  FDA guidelines for cosmetic product warning  statements No medical claims that are unsubstantiated by  FDA Production lot  Animal treats must meet federal guidance  Seed – WV Code 19-16  Must be in English  Cannot be attractive to children  Can not state false information  Net weight  Contact information  CBD or THC content if applicable  Serving size and content per package  Allergens 

Inspections & Testing  WVDA will conduct random inspections  WVDA will analyze samples for contaminants and label claims  Only samples collected by WVDA shall be considered official

Enforcement Actions for Unregistered Sellers and Manufacturers First Offense -Notified and given 14 days to register -Product embargoed if does not register within time frame Second Offense -Notified and given 14 days to register -Issued a $250 fine -Product embargoed if does not register within time frame Third Offense -Notified and product embargoed -Issued a $250 fine -Registration suspension hearing

Product Violation Classes Class I- Flagrant Class II- Faulty or Class III- Negligent Careless Unsafe Products Falsification of Improper labeling application Adulterated Products Misbranding No dosage Immediate Health Concern Failure to meet label claims Over 0.3% THC

Enforcement Actions for Product Violations Class I Class II Class III 1 st violation -Notification and -Notification -Notification embargo of -Fine of $250 -Fine of $100 product -30 days to fix -30 days to fix -Fine of $250 violation violation -Hearing 2 nd violation NA -Notification -Notification -Additional $200 -Additional $100 penalty penalty -7 days to correct -7 days to correct violation 3 rd violation NA -Notification of -Notification of Hearing Hearing

Summary  All sellers and distributors of hemp products must register with the WVDA annually  All manufacturers of hemp products must register with the WVDA annually  Manufacturers must provide a COA and label at the time of registration

Contact Info… Amie Minor West Virginia Department of Agriculture Regulatory & Environmental Affairs Division 304-558-2226 aminor@wvda.us