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,

• r 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 aminor@wvda.us