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

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Page 1: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

61CSR30

Hemp Products RuleWest Virginia Department of Agriculture

Public Informational Meeting

July 29, 2019

Page 2: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

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”

Page 3: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

Why regulate hemp products?

Public Safety

Consumer Protection

Industry Confidence

Page 4: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

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

Page 5: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

THC Content

Per the 2018 Farm Bill section 297B (ii)

THC must be under 0.3%

Dry weight basis

Δ9- THC post decarboxylation

Page 6: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

Decarboxylation

Non-psychoactive Psychoactive

Page 7: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

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)

Page 8: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

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.

Page 9: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

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

Page 10: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

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

Page 11: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

Certificate of Analysis

Lot

Date issued

Lab methods

Product Name

CBD content

THC content

Solvents

Pesticides

Microbial contaminants

Heavy Metals

Page 12: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

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

Page 13: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

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

Page 14: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

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

Page 15: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

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

Page 16: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

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

Page 17: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

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

Page 18: Department of Agriculture - 61CSR30 Hemp …...West Virginia Department of Agriculture Public Informational Meeting July 29, 2019 Authority –WV Code 19-12E-7 “…Production, sale,

Contact Info…

Amie Minor

West Virginia Department of Agriculture

Regulatory & Environmental Affairs Division

304-558-2226

[email protected]