IDOA recently submitted a revised version of the Illinois Hemp Plan to USDA for approval. According to the process outlined by the Joint Committee on Administrative Rules (JCAR) and the Illinois Administrative Procedure Act, "New rules and rule amendments must undergo public comment and JCAR review prior to adoption." The 45 day public comment period has ended and the process of adopting changes can take between 90 days to a year to complete
We have submitted our comment (below) and have requested a public hearing.
Introduction
We would like to thank the IDOA and the State of Illinois for continuing to pursue positive change for the Illinois hemp industry. Since its inception in 2019, the hemp production program in Illinois has created opportunities for small businesses and entrepreneurs to explore a new frontier in agriculture.
Without the dedicated individuals who represent our State’s Department of Agriculture working tirelessly to implement the program, the Illinois hemp industry would not be at the forefront of production and innovation in the space.
As an Association representing more than 100 members in the state of Illinois, the Illinois Hemp Growers Association (IHGA) has been dedicated to representing the hemp industry’s best interests at the local level since 2018.
We kindly submit the following comment to the Illinois Department of Agriculture (IDOA) for consideration during the public comment period now in effect regarding the current Hemp Plan submitted by IDOA for United States Department of Agriculture (USDA) approval.
Executive Summary
The following comment is based on two significant additions to the current iteration of the IDOA Hemp Plan.
1. Include language provided and otherwise approved by the United States Department of Agriculture for Performance Based Sampling (PBS) Protocols.
We urge the IDOA to implement PBS language provided by the USDA’s Final Rule as well as other clearly beneficial specific language used in other States’ Hemp Plans which have already been approved by the USDA. The benefits of PBS will not only to reduce the burden on designated sampling agents but also to reduce the burden of regulatory administration and enforcement on both citizens and State.
Compliance testing can be costly and complex to navigate, especially for small businesses. Most importantly, there are a wide variety of end-uses a cultivator may establish a hemp crop for which drastically reduce or even eliminate the need for Tetrahydrocannabinol (THC) compliance testing. Under the current iteration of the IDOA Hemp Plan, all of these crops must be sampled and tested according to standard protocols.
2. Include new definitions to be retroactively added to 505 ILCS 89 via amendment regarding hemp extract to solidify and enhance the position of producers and retailers within the current market while addressing public safety concerns.
Now is the time to create a clear legal bulwark within Illinois to protect producers and mitigate public safety concerns. We are aware that hemp derived cannabinoids are a particularly controversial subject within the much broader hemp and cannabis industries. We are also aware that the USDA requires strict adherence by state departments of agriculture to the language of the USDA Final Rule.
The IHGA has recently conducted a thorough review of the hemp plans from all 44 States, 53 Tribes, and 2 Territories that have received USDA approval. We believe that both of the suggestions within this comment are logical, helpful, and enforceable additions that do not conflict with what has already been approved by the USDA for other States.
The following pages contain detailed arguments and technical suggestions regarding implementation for the two points above.
Performance Based Sampling Protocols
Argument
According to the USDA Final Rule, “The flexibilities of (PBS) provided to States with primary regulatory authority over hemp in their jurisdiction will likely reduce the number of samples required to be collected and thus reduce the burden on designated sampling agents.”
It is reasonable to presume that the quote above asserts the objective of compliance can be satisfactorily ensured through means other than the established standard sampling and testing protocol.
Furthermore, the Final Rule recommends that States seeking primary regulatory authority over hemp in their jurisdiction avoid prescriptive PBS requirements and instead provide flexibility, “If the objective or intended result can be achieved by setting a readily measurable standard that is enforceable, the proposed requirement should merely specify the objective or result to be obtained rather than prescribe to the licensee how the objective or result is to be attained.”
Based on suggestions from our membership, years of experience in the industry, and our recent research, we believe that there are readily measurable standards which enable PBS that should be included in the IDOA Hemp Plan. Standards that are simple to enforce, will satisfy the objective of ensuring compliance, and still align with the USDA Final Rule.
Other States with USDA approved hemp plans are aligned with this perspective and have taken the initiative to benefit license holders by implementing various ways to enable PBS. Specifically, 9 States and 1 Tribe with approved hemp plans have included language related to PBS.
Hemp plans from the list above, along with language provided by the USDA Final Rule have served as the lodestar used to form the basis of the following technical suggestions regarding implementation of alternative methods.
Alternative Methods
The alternative methods will ensure, at a confidence level of 95 percent, that the cannabis plants produced under the guidelines of an alternative method will not test above the acceptable hemp THC level. The alternative methods in this protocol include the following intended uses of hemp:
1. Seedlings, clones, mothers and other nursery-style cultivations of immature plants that are harvested and sold prior to flowering
Due to extremely low levels of cannabinoids in the very immature plants, the sampling and testing of every harvest lot is impractical and unnecessary. The transfer of hemp transplants or mother plants from one location to the location at which the plants will be harvested shall not be considered a harvest. There are no flowers to test and THC content in plant tissue is negligible.
2. Sprouts, microgreens, and baby greens
Due to extremely low levels of cannabinoids in the very immature plants, the sampling and testing of every harvest lot is impractical and unnecessary. There are no flowers to test and THC content in plant tissue is negligible.
3. Fiber harvested at technical maturity
Harvesting at technical maturity ensures the termination of the crop prior to the onset of flowering when cannabinoid production occurs. There are no flowers to test and THC content in plant tissue is negligible. The sampling and testing of every harvest lot is impractical and unnecessary.
4. Grain harvested at biological maturity
Due to extremely low levels of cannabinoids in the seed itself and as a result of the grain ripening and harvest processes being inextricably linked to the inherent destruction of floral material, the sampling and testing of every harvest lot is impractical and unnecessary.
5. Monoecious varieties
Due to extremely low levels of cannabinoids throughout their entire lifecycle, the sampling and testing of every harvest lot is impractical and unnecessary.
6. Other non-feminized densely planted stands not intended for harvest
The sampling and testing of every lot of densely planted non-feminized varieties which function as a cover crop, food plot, or other similar use not intended for harvest with an average density of at least 10 plants per square foot is impractical and unnecessary.
License holders must indicate to IDOA when filing a Planting Report that the purpose of the planting is one of the intended uses listed above so any necessary performance-based compliance activities can be scheduled. The IDOA may grant an exception to standard sampling protocol if the Department is notified at the time of the Planting Report.
Alternative compliance and sampling protocol under this exception will include:
A producer shall provide documentation to the Department prior to planting, that demonstrates the seeds that are used to produce a hemp crop originated from a variety that meets the definition of hemp by having been produced under compliance by a licensed hemp producer under a state, tribal, or federal authorized program, or from a foreign supplier that meets USDA import requirements.
Visual verification by the Department that for each planting, hemp crops are being produced according to the intended uses listed above. This may include the producer providing photographic or other recorded media or documentation confirming planting date, current life cycle stage, planting density, harvest date, and all other reasonable requests for any readily measurable standard from the Department for the purposes of achieving the objective of compliance.
An exception granted under these conditions does not exempt a producer from following all reporting and notification requirements.
The Department reserves the right to conduct a records inspection, sample, and test any hemp lot at any time to determine hemp THC levels.
A hemp producer that is authorized to produce hemp for the intended uses listed above may request a certificate from the Department for the interstate shipment of specified harvest lots that meet the performance based protocol.
Defining Hemp Extract
Politicians, cannabis industry groups, and other special interests have raised concerns about the lack of more stringent health and safety regulation of hemp derived cannabinoids in comparison to cannabis and its derivatives. Inconsistent formulations, unlimited maximum dosages, lack of accurate and informative standardized labeling, age restrictions, product contamination, and a lack of safety data on long term use of novel cannabinoids are the most common concerns we have found through our research. Whether these concerns are raised in good faith out of an initiative to protect public safety from a purported threat or purely out of a desire to protect personal investments, the topic has become increasingly visible to members of the public who now seek action from legislators.
The IHGA believes that States should have primary regulatory authority over hemp in their jurisdictions and that includes all forms of hemp defined in the Farm Bill and recently upheld by the Ninth Circuit Court of Appeals.
States like California have taken it upon themselves to prohibit what they consider to be intoxicating hemp derived cannabinoids. Cannabis industry groups lauded the State for this development, but continue to lament the lack of actual enforcement. The approach of prohibition is one that sacrifices all else in the name of safety. This only perpetuates illegal markets and will not put an end to the social problems it causes. In our view, this is not a suitable example to follow when seeking successful policy that will benefit consumers as well as producers.
Regardless of any ongoing debates about regulating specific cannabinoids, the Illinois Hemp Plan as it stands must conform to the current legal definitions set forth in the Farm Bill and rules established in the Final Rule.
We believe that there are successful examples of States exercising their rights as primary regulatory authority over hemp to legislate mutually beneficial additional definitions beyond those defined in the Farm Bill. The example we would like to focus on and use as the basis for our suggestion comes from Florida’s USDA approved hemp plan, and recent relevant updates to the 2022 Florida Statutes (581.217).
The Florida Department of Agriculture and Consumer Services (FDACS) has on record a USDA approved hemp plan that defines hemp extract along with other key concepts related to consumer safety not found in the IDOA Hemp Plan. The Florida plan gives regulatory authority over hemp extracts and hemp products (including foods) containing more than trace amounts of cannabinoids intended for ingestion or inhalation to the FDACS Food Safety Division and the Florida Department of Health (FLDOH), the latter of which subsequently helped develop a hemp retailer license and additional guidelines for food establishments.
We believe that in order to adopt aspects of the FDACS Hemp Plan into the IDOA Hemp Plan, a combination of changes must be made to both the IDOA Hemp Plan and to 505 ILCS 89. Our suggestion is to include the proposed changes herein into the IDOA Hemp Plan immediately during the current submission period and retroactively push to amend 505 ILCS 89 upon USDA approval of the plan.
We are aware that the IDOA has a food safety division responsible for permitting and inspection of food establishments, inspection of food products, and performance of specialized laboratory analysis on a variety of food products sold or produced in the state. The Department monitors food from farm gate, through processing and distribution to the retail point of purchase. We see the technical suggestions for additional definitions and rules related to hemp extract below as aligned with USDA guidelines, mutually beneficial for both consumers and producers, and as independently enforceable by the Department based on their current scope of operations.
We also acknowledge that further iteration and collaboration with the Illinois Department of Public Health (IDPH) may be necessary for a comprehensive implementation that is satisfactory for all stakeholders due to the IDPH’s adoption of U.S Food and Drug Administration (FDA) code. According to the FDA, “The 2018 Farm Bill explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food Drug and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act (PHS Act). FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products.”
For several years now the FDA has maintained that any product containing cannabinoids derived from hemp marketed as a food, drug, dietary supplement, or food additive intended for human or animal consumption is illegal and prohibited from entering interstate commerce according to the FD&C Act. However, the primary concern of the FDA are Cannabis Derived Products (CDP) being marketed as drugs with claims of treating disease affecting vulnerable populations. Most warning letters issued and other enforcement activity performed by the FDA has been focused on this category of violations. Recent headlines suggesting FDA will soon move to regulate or provide guidance on regulating cannabinoids in food are unlikely to amount to any meaningful or positive changes.
As of October 2021, the FDA acknowledges that, “Overall, the growth of the CDP market continues to outpace the growth in the science and our understanding of the public health implications of these products.” Therefore, the IHGA asserts that it is justified and necessary to take action at the State level in Illinois regarding hemp extract based CDPs to solidify and enhance the position of producers and retailers within the current intrastate market while addressing public safety concerns.
Definitions
Definitions to be added via amendment of 505 ILCS 89:
“Batch” means the Hemp Extract produced during a period of time under similar conditions and identified by a specific code that allows traceability.
“Contaminants unsafe for human consumption” includes, but is not limited to, any microbe, fungus, yeast, mildew, herbicide, pesticide, fungicide, residual solvent, metal, or other contaminant found in any amount that exceeds any of the accepted limitations as determined by rules adopted by the Department of Health or other limitation pursuant to the laws of this state, whichever amount is less.
“Hemp extract” means a substance or compound intended for ingestion, containing more than trace amounts of cannabinoid, or for inhalation which is derived from or contains hemp and which does not contain other controlled substances. The term does not include synthetic CBD or seeds or seed-derived ingredients that are generally recognized as safe by the United States Food and Drug Administration.
“Ingestion” means the process of consuming Hemp Extract through the mouth, whether by swallowing into the gastrointestinal system or through tissue absorption.
“Inhalation” means the process of consuming Hemp Extract through the mouth or nasal passages into the respiratory system.
Rules
Rules to be added to IDOA Hemp Plan:
Distribution and Retail Sale of Hemp Extract
Hemp extract may only be distributed and sold in the state if the product:
Has a certificate of analysis prepared by an approved testing laboratory that states:
The hemp extract is the product of a batch tested by the independent testing laboratory;
The batch contained a total delta-9-tetrahydrocannabinol concentration that did not exceed 0.3 percent pursuant to the testing of a random sample of the batch; and
The batch does not contain contaminants unsafe for human consumption.
Is distributed or sold in a container that minimizes exposure to light to prevent degradation of cannabinoids and includes:
A scannable barcode or quick response code linked to the certificate of analysis of the hemp extract batch by an approved testing laboratory;
The batch number;
The Internet address of a website where batch information may be obtained;
The expiration date; and
The number of milligrams of each marketed cannabinoid per serving.
A disclaimer which shall state: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Hemp extract distributed or sold in violation of this section shall be considered adulterated or misbranded pursuant to state law.
Products that are intended for inhalation and contain hemp extract may not be sold in this state to a person who is under 21 years of age.
Hemp Extract intended for Human Consumption that is not clearly labeled as intended for Inhalation or Ingestion must meet all of the requirements for products intended for both Inhalation and Ingestion as provided in this rule. In the event that there are different requirements, the stricter standard shall apply.
Industrial Hemp Advisory Board Language
As an addendum, the IHGA would also like to suggest the creation of an Industrial Hemp Advisory Board within the Industrial Hemp Act. A board of advisors would be responsible for bringing helpful suggestions like the ones in this document to the attention of the Department on a regular basis.
Amendment to Section 18 of the Industrial Hemp Act
Moneys in the Fund shall also be utilized by the Department to appoint an advisory board to advise the Department on matters regarding the regulation of industrial hemp and to assist the Department in promulgating rules to carry out this article. The Department shall appoint ten members to the Illinois Hemp Product Advisory Board as follows:
1. One member with experience in industrial hemp regulation
2. One member with experience in industrial hemp education
3. One member representing the hemp manufacturing industry
4. One member who is a farmer of natural fiber crops
5. One member who is a farmer of grain and oilseed crops
6. One member who is a plant medicine specialist
7. One member with experience in seed development and genetics
8. One member with experience in technology and data security
9. One member representing social equity
10. One member representing veterans
(a) The term of office of members of the committee is three years; except members 4 and 5 for which the term of office is two years.
(b) Each advisory board member holds office until his or her term of office expires or until a successor is duly appointed. If a vacancy occurs on the board, the appointing authorities shall appoint a new member meeting the qualifications of the member vacating the position to serve the remainder of the unexpired term of the member.
(c) Members of the advisory board shall receive a monthly stipend of no less than $400.00 and are entitled to reimbursement for actual and necessary travel and subsistence expenses incurred in the performance of their official duties as members of the advisory board.
(d) The advisory board shall provide comprehensive advice to the Department, thoroughly review proposed rules, and regularly recommend new rules or changes to existing rules.
(e) Members must fulfill the duties and responsibilities listed in this section and must resign if they are unable to do so for more than one month of each calendar year.
(f) The advisory board shall meet monthly and report to the Department quarterly regarding their duties and responsibilities.
Conclusion
As we embark upon our 5th year of operation, the Illinois Hemp Growers Association remains committed to representing the hemp industry’s best interests and achieving positive change for the Illinois Hemp Industry.
We are happy to answer any questions based on this comment. We look forward to continuing to work with the IDOA and the State of Illinois and extend our most sincere gratitude for your time and consideration regarding this important matter.