department of agriculture - 61csr30 hemp …...west virginia department of agriculture public...
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61CSR30
Hemp Products RuleWest 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 Hemp seed derivates
Hemp concentrates or extracts
Hemp edibles
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
Not Covered Hemp that has not been processed
Hemp that has been minimally processed
Agricultural hemp seed
THC Content
Per the 2018 Farm Bill section 297B (ii)
THC must be under 0.3%
Dry weight basis
Δ9- 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 31st
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
Careless
Class III- Negligent
Unsafe Products
Adulterated Products
Immediate Health
Concern
Over 0.3% THC
Falsification of
application
No dosage
Failure to meet label
claims
Improper labeling
Misbranding
Enforcement Actions for Product
Violations
Class I Class II Class III
1st violation -Notification and
embargo of
product
-Fine of $250
-Hearing
-Notification
-Fine of $250
-30 days to fix
violation
-Notification
-Fine of $100
-30 days to fix
violation
2nd violation NA -Notification
-Additional $200
penalty
-7 days to correct
violation
-Notification
-Additional $100
penalty
-7 days to correct
3rd violation NA -Notification of
Hearing
-Notification of
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