This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives. STORAGE NAME: h1475.ACR DATE: 3/23/2023 HOUSE OF REPRESENTATIVES STAFF ANALYSIS BILL #: HB 1475 Hemp SPONSOR(S): Robinson, W. and others TIED BILLS: IDEN./SIM. BILLS: CS/SB 1676 REFERENCE ACTION ANALYST STAFF DIRECTOR or BUDGET/POLICY CHIEF 1) Agriculture, Conservation & Resiliency Subcommittee Gawin Moore 2) Agriculture & Natural Resources Appropriations Subcommittee 3) Infrastructure Strategies Committee SUMMARY ANALYSIS Hemp, also called industrial hemp, is defined as the plant Cannabis sativa L. and any part of that plant, including seeds, derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers thereof, whether growing or not, with a delta-9 tetrahydrocannabinol (THC) concentration that does not exceed 0.3 percent on a dry weight basis. Hemp is used to create hemp extract, which is defined as “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.” In 2019, the Legislature created the State Hemp Program within the Department of Agriculture and Consumer Services (DACS), which authorizes the cultivation of hemp and sale of hemp extract products. Hemp extract products are available throughout the state in various forms including, but not limited to, oils, lotions, and gummies. Hemp extract products are only authorized to be distributed in the state if the product meets certain requirements established by DACS. Hemp extract products meant for inhalation may not be sold to individuals under the age of 21. The bill revises definitions of food, hemp, and hemp extract and defines synthetically derived cannabinoid and total THC. The bill requires any hemp extract that will be distributed and sold in the state to have come from a batch processed in a facility permitted by a human health or food safety regulatory entity and that meets human health or food safety sanitization requirements. The bill requires hemp extract to be distributed and sold in a container that is suitable to contain products for human consumption, is composed of materials designed to minimize exposure to light, mitigates exposure to high temperatures, is not attractive to children, and is compliant with the United States Poison Prevention Packaging Act of 1970. The bill specifies that hemp extract may only be sold to a business in the state if that business is properly permitted. The bill specifies that hemp extract products intended for human ingestion may not be sold to anyone under 21 years of age. Additionally, hemp extract products intended for human ingestion or inhalation may not exceed 0.5 milligrams of total THC per dose or 2 milligrams total THC per container. The bill requires DACS to adopt rules for the State Hemp Program that provide packaging and labeling requirements and establish calculations for determining total THC. The bill may have an insignificant negative fiscal impact on the state. STORAGE NAME: h1475.ACR PAGE: 2 DATE: 3/23/2023 FULL ANALYSIS I. SUBSTANTIVE ANALYSIS A. EFFECT OF PROPOSED CHANGES: Background Hemp Hemp, also called industrial hemp, is defined as the plant Cannabis sativa L. and any part of that plant, including seeds, derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers thereof, whether growing or not, with a delta-9 tetrahydrocannabinol (THC) concentration 1 that does not exceed 0.3 percent on a dry weight basis. 2 While hemp and marijuana are both grown from the Cannabis sativa L. plant, they are different varieties that have been genetically bred and grown for different uses. Hemp can be distinguished from marijuana 3 by its lower concentrations of THC, and higher concentrations of cannabidiol (CBD). 4 CBD does not have psychoactive properties like marijuana does and does not produce a “high.” 5 Hemp is used to create hemp extract, which is defined as “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.” 6 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. 7 Hemp Cultivation The Agricultural Act of 2014 authorized an institution of higher education or a state department of agriculture to grow or cultivate industrial hemp if it is grown or cultivated for research conducted under an agricultural pilot program or other agricultural or academic research program provided the growing or cultivating of industrial hemp is allowed under state law where the university or state department of agriculture is located. 8 In 2017, the Legislature authorized the Department of Agriculture and Consumer Services (DACS) to oversee the development of industrial hemp pilot projects for the Institute of Food and Agricultural Science (IFAS) at the University of Florida, Florida Agricultural and Mechanical University, and any land grant university in the state that has a college of agriculture. 9 The purpose of the pilot projects was to cultivate, process, test, research, create, and market safe and effective commercial applications for industrial hemp in the agricultural sector. 10 Section 10113 of the Agriculture Improvement Act of 2018 (2018 Farm Bill) created the Hemp Farming Act to allow the cultivation of hemp beyond industrial hemp pilot programs. The 2018 Farm Bill removed hemp-derived products from Schedule I of the Controlled Substances Act. While the law 1 “Total delta-9 THC concentration” means delta-9 THC + (0.877 x THC acid), r. 5B-57.014(1)(i), F.A.C. 2 7 U.S.C. s. 5940 (2014); 7 U.S.C. s. 1639o (2018); “Dry weight basis” refers to a method of determining the percentage of a chemical in a substance after removing the moisture from the substance. Percentage of THC on a dry weight basis means the percentage of THC, by weight, in a cannabis item (plant, extract, or other derivative), after excluding moisture from the item. 7 C.F.R. s. 990 (2021). 3 Marijuana is identified in the United States drug laws as cannabis having high THC levels that are associated with psychotropic effects and is typically made from the flowering tops and leaves of the Cannabis sativa L. plant (sativa or indica varieties); The Controlled Substances Act was enacted as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970; 84 s. 1236 (1970). 4 National Conference of State Legislatures (NCSL), State Industrial Hemp Statutes, available at http://www.ncsl.org/research/agriculture-and-rural-development/state-industrial-hemp-statutes.aspx (last visited Mar. 10, 2023). 5 Centers for Disease Control and Prevention (CDC), CBD: What You Need to Know, https://www.cdc.gov/marijuana/featured- topics/CBD.html (last visited Mar. 18, 2023). 6 Section 581.217(3)(e), F.S. 7 Id. 8 7 U.S.C. s. 5940 (2014); Mindy Bridges and Karmen Hanson, Regulating Hemp and Cannabis-Based Products, NCSL (April 2022), available at https://documents.ncsl.org/wwwncsl/Agriculture/lb_2537.pdf (last visited Jan. 29, 2019). 9 Chapter 2017-124, Laws of Fla.; s. 1004.4473, F.S. 10 Section 1004.4473(2)(a), F.S. STORAGE NAME: h1475.ACR PAGE: 3 DATE: 3/23/2023 legalized hemp as an agricultural product, the law did not legalize CBD generally. 11 CBDs derived from hemp are considered legal if the hemp is grown by a licensed grower, produced in a manner that is consistent with the 2018 Farm Bill, and complies with other federal and state regulations. 12 In 2019, the Legislature created the state hemp program within DACS, 13 which was approved by the Secretary of the United States Department of Agriculture in 2020. 14 To grow hemp in Florida, each potential hemp grower must obtain a cultivation license from DACS. 15 Within 30 days prior to harvest, DACS, or its agent, is required to collect a representative sample from each lot to be tested for total delta-9 THC concentration. 16 DACS, or its agent, will then send those samples to an independent testing laboratory, 17 and if the sample comes back with an acceptable level of THC, the hemp grower may harvest their hemp crop. 18 Sale of Hemp Extract Products Hemp extract products are available throughout the state in various forms, including, but not limited to, oils, lotions, and gummies. Hemp extract products may only be distributed in the state if the product has a certificate of analysis prepared by an independent testing laboratory that verifies the hemp extract does not exceed 0.3 percent total delta-9 THC on a dry weight basis; does not contain contaminants unsafe for human consumption; and the container includes, among other information, the expiration date and number of milligrams of each marketed cannabinoid per serving. 19 Hemp extract products meant for inhalation may not be sold to individuals under the age of 21. 20 Since the passage of the 2018 Farm Bill and approval of the state hemp program, various other cannabinoid products have appeared on the market. 21 While such cannabinoids can naturally occur within the cannabis plant, certain cannabinoids like delta-8 THC are not found in significant amounts and must be synthetically derived from CBD. 22 The United States Food and Drug Administration (FDA) has issued a warning stating delta-8 THC products have not been approved by the FDA for safe use. 23 Additionally, the CDC recommends that all CBD and THC products are kept in childproof containers and are placed out of reach of children due to the unknown effect of such products on children. 24 Food Safety DACS is the agency responsible for the enforcement of the production, manufacture, transportation, and sale of food. DACS’s Division of Food Safety is directly responsible for assuring the public of a safe, wholesome, and properly represented food supply. 25 The division accomplishes this through the 11 7 U.S.C. s. 1639o (2018). 12 John Hudak, The Farm Bill, hemp legalization and the status of CBD: An Explainer, Brookings Dec. 14, 2018, available at https://www.brookings.edu/blog/fixgov/2018/12/14/the-farm-bill-hemp-and-cbd-explainer/ (last visited Mar. 10, 2023). 13 Ch. 2019-132, L.O.F. 14 USDA, Status of State and Tribal Hemp Production Plans for USDA Approval, https://www.ams.usda.gov/rules- regulations/hemp/state-and-tribal-plan-review (last visited Mar. 9, 2023); USDA, Florida State Hemp Plan, available at https://www.ams.usda.gov/sites/default/files/media/FloridaStateHempPlan.pdf (last visited Mar. 9, 2023). 15 Rule 5B-57.014(4), F.A.C. 16 Rule 5B-57.014(8)(a), F.A.C. 17 See Rule 5B-57.014(1)(d), F.A.C. for lab requirements. See also DACS, Approved Designated Laboratories for THC Testing, available at https://www.fdacs.gov/content/download/92484/file/approved-designated-labs-01-18-2023.pdf (last visited Mar. 10, 2023). 18 Rule 5B-57.014(8)(g), F.A.C. 19 Section 581.217(7), F.S. 20 Section 581.217(7)(c), F.S. 21 The federal and state hemp regulations do not specifically address THCs other than delta-9 THC in the definition of hemp, which has caused debate and concern among various stakeholders. The United States Drug Enforcement Agency (DEA) recently listed delta- 8 THC as a Schedule I narcotic in the Orange Book. DEA, Controlled Substances (last updated Feb. 15, 2023), available at https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf (last visited Mar. 18, 2023). 22 United States Food and Drug Administration (FDA), 5 Things to Know about Delta-8 Tetrahydrocannabinol- Delta-8 THC, https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc (last visited Mar. 10, 2023). 23 Id. 24 CDC, CBD: What You Need to Know, https://www.cdc.gov/marijuana/featured-topics/CBD.html (last visited Mar. 18, 2023). 25 DACS, Division of Food Safety, https://www.fdacs.gov/Divisions-Offices/Food-Safety (last visited March 10, 2023). STORAGE NAME: h1475.ACR PAGE: 4 DATE: 3/23/2023 permitting and inspection of food establishments, the inspection and evaluation of food products, and the performance of specialized laboratory testing on a variety of food products sold or produced in Florida. The division also proactively monitors food from manufacturing and distribution to retail. Effect of the Bill The bill specifies that the definition of food includes hemp extract, which allows DACS to regulate hemp extract as a food product under its food safety regulations, and requires time and temperature control for the safety and integrity of the product. The bill specifies that hemp-derived cannabinoids including, but not limited to, cannabinol, are not controlled substances or adulterants if they comply with State Hemp Program regulations. The bill revises the definition of hemp to specify that hemp extract may not exceed 0.3 percent total delta-9 THC on a wet weight basis. Additionally, the bill specifies that synthetically derived cannabinoids are not included in the definition of hemp. The bill also revises the definition of hemp extract to include snuff, chewing gum, and smokeless products derived from or containing hemp, but specifies the term does not include cannabinoids that are synthetically derived. The bill defines a synthetically derived cannabinoid to mean any cannabinoid created by reacting a cannabis- or noncannabis- derived extract with solvent or acid to increase the concentration of a present cannabinoid or to create a new cannabinoid not originally found in the extract. The bill also defines total THC to mean the sum of all THC isomers, with a concentration of more THC acid multiplied by 0.877, in milligrams per gram multiplied by the labeled weight of the product. The bill requires any hemp extract that will be distributed and sold in the state to have come from a batch that was processed in a facility that holds a current and valid permit issued by a human health or food safety regulatory entity with authority over the facility, and that meets the human health or food safety sanitization requirements of the regulatory entity. Such compliance must be documented by a report from the regulatory entity confirming that the facility meets such requirements. The bill requires hemp extract to be distributed and sold in a container that is suitable to contain products for human consumption, is composed of materials designed to minimize exposure to light, mitigates exposure to high temperatures, is not attractive to children, and is compliant with the United States Poison Prevention Packaging Act of 1970. The bill specifies that hemp extract may only be sold to a business in the state if that business is properly permitted. The bill specifies that hemp extract products for human ingestion may not be sold to anyone under 21 years of age. Additionally, hemp extract products intended for human ingestion or inhalation may not exceed 0.5 milligrams of total THC per dose or 2 milligrams total THC per container. The bill requires DACS to adopt rules for the State Hemp Program that provide packaging and labeling requirements that ensure that hemp extract intended for human ingestion or inhalation is not attractive to children and advertising regulations that ensure hemp extract intended for human ingestion or inhalation is not marketed or advertised in a manner that specifically targets or is attractive to children. The bill requires DACS to adopt rules to establish THC isomers to include in calculating total THC, which must include, at a minimum, delta-8 THC, delta-9 THC, delta-10 THC, exo-THC, and hexahydro- THC. B. SECTION DIRECTORY: Section 1. Amends s. 500.03, F.S., to specify hemp extract is a food product and must follow food safety protocols. Section 2. Amends s. 581.217, F.S., to specify hemp extract regulations. Section 3. Reenacts s. 893.02, F.S. STORAGE NAME: h1475.ACR PAGE: 5 DATE: 3/23/2023 Section 4. Provides an effective date of July 1, 2023. II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT A. FISCAL IMPACT ON STATE GOVERNMENT: 1. Revenues: None. 2. Expenditures: The bill may have an indeterminate negative fiscal impact on DACS related to the regulation of hemp as a food product. B. FISCAL IMPACT ON LOCAL GOVERNMENTS: 1. Revenues: None. 2. Expenditures: None. C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR: The bill may have an indeterminate negative fiscal impact on the private sector associated with the THC limits and new packaging requirements of the bill. D. FISCAL COMMENTS: None. III. COMMENTS A. CONSTITUTIONAL ISSUES: 1. Applicability of Municipality/County Mandates Provision: Not applicable. This bill does not appear to affect county or municipal government. 2. Other: None. B. RULE-MAKING AUTHORITY: The bill requires DACS to adopt rules related to new packaging requirements for hemp extract and the total concentration of THC in hemp extract products. C. DRAFTING ISSUES OR OTHER COMMENTS: None. IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES Not applicable.