State Hemp Program 2

(1) Pursuant to s. 581.217, F.S., and in accordance with 7 U.S.C. Section 1639p, the Department shall authorize 3

and oversee the development of the state hemp program to regulate the cultivation of hemp in the state, which is a 4

potentially invasive plant species and is a threat to the plant life of this state if not properly controlled. Hemp 5

cultivated pursuant to this rule is considered an agricultural commodity. 6

(2) Definitions. The definitions provided in s. 581.217, F.S., and the following shall apply to this rule: 7

(a) “Hemp biomass” means non-food plant matter, including stalks, seed hulls, woody biomass, and hemp 8

flowers (post extraction). 9

(b) The word “Person” includes individuals, children, firms, associations, joint adventures, partnerships, estates, 10

trusts, business trusts, syndicates, fiduciaries, corporations, and all other groups or combinations. 11

variety or strain of hemp throughout the area. 13

(3) Pursuant to ss. 581.031(1), (3), (5), F.S., it is unlawful for any Person to introduce into this state or move 14

through this state hemp or hemp plant parts unless introduced or moved in compliance with this rule. 15

(4) Application. It is unlawful for a Person to cultivate hemp in this state without a License to Cultivate Hemp 16

issued by the Department. A Person seeking a license to cultivate hemp shall submit to the Department a complete 17

application consisting of the following: 18

(a) A completed Application for License to Cultivate Hemp FDACS-XXXXX xx/xx, incorporated herein by 19

reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. 20

(b) A detailed description of each Plot location intended for the cultivation of hemp, including address or legal 21

land description, and GPS coordinates. 22

Livescan service provider evaluated by the Florida Department of Law Enforcement for state and national 24

processing to Department ORI #_____. The Livescan service provider receipt for payment and process reference 25

number must be provided with the Application For License to Cultivate Hemp. 26

(d) An environmental containment plan for each proposed facility location. An environmental containment plan 27

must include the following: 28

1. A containment system of traps, filters, silt fences or berms, or a fallow area consisting of bare earth or ground 29

cover to prevent the Industrial Hemp from spreading through ditches, natural waterways, or other drainage. 30

2. The use of dedicated equipment for the facility or a plan to clean any equipment used on the site of all debris 31

before it is moved from the property. 32

3. A transportation and movement plan that ensures that the hemp is covered and moved in full containment 33

during transport from noncontiguous locations. 34

(e) A waste disposal plan. A detailed plan outlining the procedures the applicant will use to destroy hemp plants 35

that have been cultivated in violation of s. 581.217, F.S. or the rules promulgated therefrom. A waste disposal plan 36

must include the following: 37

1. A statement of the estimated costs to destroy the hemp plants, 38

2. The method of disposal using chemical or mechanical processes that will be applied to ensure that all hemp 39

plants are rendered non-viable. Pursuant to s. 381.986(8)(e), F.S., hemp cultivated under this rule is not eligible to be 40

sold by a licensed medical marijuana treatment center. Accordingly, the sale of hemp or hemp extract to a medical 41

marijuana treatment center is not an approved method of disposal. 42

(f) Proof of an Agricultural Bond if required by this rule. 43

(5) Cultivation requirements. The licensee shall comply with the following requirements: 44

(a) The licensee’s environmental containment plan. 45

(b) The licensee’s waste disposal plan. 46

must be provided to the Department upon request. 48

(d) Maintain the certification, label, and receipts for all certified hemp seed used in cultivation of hemp for three 49

(3) years. These documents must be provided to the Department upon request. 50

(e) Use only certified hemp seed as defined in Rule 5E-4.016(2), F.A.C or nursery stock obtained from a Florida 51

nursery registered with the Department that was grown from certified hemp seed. 52

(f) In accordance with s. 581.083, F.S., hemp may only be cultivated on lands that are used primarily for bona 53

fide agricultural purposes pursuant to s. 193.461, F.S. Two years after adoption of this rule, The Noxious Weed and 54

Invasive Plant Review Committee and the Hemp Advisory Committee shall evaluate and make separate 55

recommendations to the Department whether it is necessary to continue restricting cultivation of Hemp to lands that 56

are used primarily for bona fide agricultural purposes pursuant to s. 193.461, F.S. 57

(g) A License to Cultivate Hemp expires twelve months after the date of issuance. 58

(h) Post signage at every Plot access point which contains the following information: the Licensee’s name, the 59

Department issued license number, the licensee’s phone number, the GPS coordinates of the cultivation area, and a 60

statement that hemp is being cultivated. 61

(6) Nurseries. Nurseries propagating hemp plants for distribution shall: 62

(a) Register with the Department pursuant to s. 581.031(21), F.S. 63

(b) Only sell hemp plants for cultivation to Persons in the state of Florida who are licensed pursuant to this rule 64

or to Persons outside of Florida who are authorized to cultivate hemp under a plan authorized pursuant to 7 U.S.C. 65

1639p. 66

the Department upon request. 68

(7) Agricultural Bonds. As required by s. 581.083(4)(e), F.S., each licensee shall maintain, for each separate 69

growing location over five (5) contiguous acres, a bond in an amount of not more than 150 percent of the estimated 70

cost of removing and destroying the hemp. The bond amount determination shall be based on the biological and 71

physical factors associated with the organism being cultivated and produced, including size of the production area, 72

equipment, and products needed to eliminate the planting and organism. The maximum bond or certificate of deposit 73

required will not exceed $5,000 per acre except as allowed by s. 581.083(4)(e), F.S. The amount of the bond or 74

certificate of deposit shall be increased, upon order of the Department, at any time if the Department finds such 75

increase to be warranted by the cultivating operations of the permit holder. The increase shall be based on any 76

changes in the biological and physical factors of the organism being cultivated and produced as stated above in this 77

rule. 78

(8) Harvest. The licensee must notify the Department by email at [DPI Hemp Inspection inbox] no fewer than 79

thirty (30) days prior to each Plot’s intended harvest date. The licensee shall not harvest the Plot until the laboratory 80

results indicate that the sample does not have a total delta-9 THC concentration that exceeds 0.3 % on a dry weight 81

basis. 82

(9) THC field sampling. 83

(a) Under Department supervision and direction, the licensee shall collect a representative sample from each 84

Plot of hemp to be tested for total delta-9 tetrahydrocannabinol concentration. 85

(b) The Department shall place the sample under seal and the licensee shall submit the sample to an ISO 17025 86

accredited laboratory for testing. The methods utilized by the laboratory must be within their scope of accreditation. 87

The laboratory shall report directly to the Department and the licensee the analysis results for total delta-9 88

tetrahydrocannabinol concentration. The licensee shall not harvest the Plot until the laboratory results indicate the 89

Plot sample does not have a total delta-9 tetrahydrocannabinol concentration that exceeds 0.3 % on a dry weight 90

basis. If Plot sample results indicate that the total delta-9 tetrahydrocannabinol exceeds 0.3% on a dry weight basis, 91

the Department will perform a confirmatory test. 92

confirmatory sample results indicate the plants have a total delta-9 tetrahydrocannabinol concentration that exceeds 94

0.3 % on a dry weight basis. The licensee shall completely destroy all hemp plants, rendering the plants as non-95

viable in a manner approved by the Department using chemical or mechanical processes. However, if a licensee 96

removes and destroys all leaf or floral material from the plants, the hemp plants may be processed for barestalk 97

fiber, hulled hemp seed, hemp seed protein powder, or hemp seed oil. 98

(10) Inspections. The Department shall conduct random annual inspections of each licensee to ensure the 99

following: 100

(a) The Licensee’s environmental containment plan. 101

(b) Maintenance of seed certification documentation required under paragraph 5B-57.014(5)(d), F.A.C. 102

weight basis. 104

(d) Hemp plants are free from plant pests or disease. 105

(e) Compliance with s. 581.217, F.S. and rules promulgated therefrom. 106

(11) Transportation Requirements. 107

(a) Intrastate movement. Any Person transporting hemp within the state of Florida shall: 108

1. Transport Hemp in a fully enclosed vehicle or container when being moved between noncontiguous 109

locations. 110

2. Have in their possession a bill of lading or proof of ownership, certificate of inspection, documentation 111

showing the name, physical address, and license number of the originating licensed cultivator, and the name and 112

physical address of the recipient of the delivery when transporting between non-contiguous locations. 113

3. Stop and submit for inspection while passing any official agricultural inspection station pursuant to s. 570.15, 114

F.S. 115

(b) Interstate movement. Any Person doing business outside the State of Florida who desires to ship into this 116

state hemp plants, hemp plant products capable of hosting plant pests or diseases from any state, U.S. possession, 117

territory, or district of the United States, or foreign jurisdiction, shall comply with the following regulations: 118

1. The movement of propagative parts of hemp into the State of Florida is prohibited unless: 119

a. Accompanied by a Special Permit to Import Hemp issued by the Department. A Special Permit to Import 120

Hemp may be requested by submitting to the Division at the address shown on the form an Application for Special 121

Permit to Import Hemp, FDACS-XXXXX, xx/xx, which is incorporated herein by reference. 122

b. Accompanied by proof of origin and a phytosanitary certificate of inspection issued by a state or country 123

plant protection governmental agency. 124

c. The Person requests and submits to a special inspection pursuant to s. 581.031(23), F.S. prior to entry into the 125

State. 126

2. The movement of any hemp plants or hemp plant products capable of hosting plant pests or disease into the 127

State of Florida is prohibited unless: 128

a. Accompanied by a Permit to Import Hemp issued by the Department. A permit may be requested by 129

submitting to the Division at the address shown on the form an Application for Permit to Import Hemp, FDACS-130

XXXXX, xx/xx, which is incorporated herein by reference. 131

b. Accompanied by proof of origin and a phytosanitary certificate of inspection issued by a state or country 132

plant protection governmental agency. 133

c. The Person requests and submits to a special inspection pursuant to s. 581.031(23), F.S. prior to entry in the 134

State. 135

3. The movement of any Hemp biomass into the state of Florida is prohibited unless: 136

a. The Hemp biomass has been rendered non-viable through processing. 137

b. Accompanied by proof of origin and a phytosanitary certificate of inspection issued by a state or country 138

plant protection governmental agency. 139

c. The Person must request and submit to a special inspection outlined in s. 581.031(23), F.S. prior to entry in 140

the State. 141

4. Upon entry in the state, all persons transporting propagative parts of hemp, hemp plants, hemp plant products, 142

or Hemp biomass must comply with the intrastate movement requirements outlined in this rule. 143

(12) Abandoned operations. It is the responsibility of the licensee to completely destroy all hemp plant material, 144

rendering the plants as non-viable in a manner approved by the Department using chemical or mechanical processes 145

prior to vacating the property or stopping hemp cultivation. Failure of the permit holder to destroy the hemp will 146

result in an immediate final order by the Department and action against the licensee’s bond. 147

(13) Violations. A licensee must complete a corrective action plan if the Department determines that the 148

licensee has negligently violated s. 581.217, F.S. or this rule. A licensee who negligently violates the corrective 149

action plan under this rule three times within five (5) years is ineligible to cultivate hemp for five (5) years following 150

the date of the third violation. If the Department determines that a licensee has violated s. 581.217, F.S. or 151

Department rules with a culpable mental state greater than negligence, the Department shall immediately report the 152

licensee to the Attorney General and the United States Attorney General. A determination that a licensee has 153

negligently violated s. 581.217, F.S. or this rule shall be subject to the process outlined in ss. 120.569 and 120.57-154

120-595. A determination that a licensee has violated s. 581.217, F.S. or Department rule with a culpable mental 155

state greater than negligence shall be reported to the Attorney General and the United States Attorney General 156

notwithstanding ss. 120.569 and 120.57-120-595. 157

(14) Final Order. The Department may issue an immediate final order directing the licensee to immediately 158

destroy any hemp cultivated in violation of s. 581.217, F.S. and the rules promulgated therefrom. 159

(15) Byproducts. Any processing byproduct that contains a total delta-9 tetrahydrocannabinol concentration 160

exceeding 0.3% on a dry weight basis must be destroyed in accordance with the licensee’s waste disposal plan. 161

(16) Destruction verification. Upon destruction of the product, the licensee shall notify the Department via 162

FDACS-XXXXX xx/xx, incorporated herein by reference and available online at 163

https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. 164

Rulemaking Authority …. Law Implemented …. History–New . 165

166

5E-4.006 Seed Standards. 167

The minimum germination standard for agricultural seeds shall be 60% (including hard seed or dormant seed) 168

except hybrid field corn seed which shall be 90%, and hemp seed, which shall be 80% (including hard or dormant 169

seed). For hemp seed which germinates less than the standard established by the Department, the words “Below 170

Standard” shall be prominently displayed on the label. Hemp seed below 60% germination may not be sold. The 171

minimum standards for vegetable seeds are set forth in the documents incorporated herein. The federal seed act 172

regulations specified in 7 CFR 201 are hereby incorporated by reference. Copies of this document may be obtained 173

from the Superintendent of Documents, Attn: New Orders, P. O. Box 371954, Pittsburgh, PA 15250-7954. Charge 174

orders may be telephoned to the Government Printing Office order desk at (202)783-3238. Also incorporated by 175

reference are the State Noxious-Weed Seed Requirements Recognized in the Administration of the Federal Seed 176

Act, January 1994 publication, and the January 1995 replacement pages for the January 1994 publication. Copies of 177

these documents may be obtained from the United States Department of Agriculture, Agricultural Marketing 178

Service, Seed Regulatory and Testing Branch, Livestock and Seed Division, Building 506, BARC-East, Beltsville, 179

MD 20705-2350; telephone (301)504-9430. 180

Rulemaking Authority 570.07(23), 578.11(2) FS. Law Implemented 578.09(2)(a), 578.11(2) FS. History–New 5-30-63, 181

Amended 1-1-65, 11-21-69, Formerly 5E-4.06, Amended 2-7-89, 6-14-95, 6-9-98, . 182

5E-4.007 Commercial Tests. 183

(1) The Ddepartment will make commercial tests of seed when such will not interfere with prescribed duties of 184

the Ddepartment. A schedule of charges is listed below: 185

Type Test and Charge

Product Purity Germination

(a) through (s) No change.

(t) Hemp

(t) through (rr) renumbered (u) through (ss) No change.

21.00 21.00

Rulemaking Authority 578.11(2) FS. Law Implemented 578.11(2) FS. History–New 6-29-62, Amended 9-29-83, Formerly 186

5E-4.07, Amended 8-17-92, . 187

5E-4.016 Certified Hemp Seed. 188

(1) A certifying agency, or an institution or university conducting an industrial hemp pilot project pursuant to s. 189

1004.4473, F.S., may certify hemp seed. 190

(2) “Certified hemp seed” means a seed produced from a cultivar or named variety having a total delta-9-191

tetrahydrocannabinol concentration that does not exceed 0.3% on a dry weight basis and is produced under a system 192

which ensures genetic purity, identity, and a given minimum level of quality. 193

(3) An institution or university conducting an industrial hemp pilot project pursuant to s. 1004.4473, F.S., that 194

elect to certify hemp seed must: 195

(a) Follow the standards for seed certification in 7 CFR Parts 201.67 – 201.78; and 196

(b) Maintain records of all hemp seed certified by the institution or university pursuant to s. 578.23, F.S. 197

Rulemaking Authority 570.07(23), 578.11(2), 581.217(12) FS. Law Implemented 570.07(16)(g), 578.011(2), 578.011(8), 198

578.23, 581.217(6),581.217(11)(d) FS. History–New . 199

5E-3.003 Inspection; Sampling; Analysis; Reporting Rejected Feed and Feedstuff; Reduced Sampling 200

Requirements; Laboratory Certification/Exemption Requirements and Fees. 201

(1) Definitions. 202

(a) through (j) No change. 203

(k) The term “pet food” means any commercial feed prepared and distributed for consumption by dogs or cats. 204

(l) The term “pet treats” means any treat as defined in 5E-3.003(1)(i), F.A.C., prepared and distributed for 205

consumption by dogs or cats. 206

(m) The term “specialty pet” means any animal normally maintained in a household, including, rodents, 207

ornamental birds, ornamental fish, reptiles and amphibians, ferrets, hedgehogs, marsupials, and rabbits not raised for 208

food or fur. 209

(n) The term “specialty pet food” means any commercial feed prepared and distributed for consumption by 210

specialty pets. 211

(o) The term “specialty pet treats” means any treat as defined in 5E-3.003(1)(i), F.A.C., prepared and distributed 212

for consumption by specialty pets. 213

(p) The term “waste disposal plan” means a detailed plan outlining the chemical or mechanical process the 214

registrant will use to destroy products containing Hemp Extract. 215

(2) through (4) No change. 216

(5) Hemp extract in pet food, pet treats, specialty pet food and specialty pet treats. 217

(a) Hemp extract as defined in s. 581.217(3)(e), F.S. used in pet food, pet treats, specialty pet food and specialty 218

pet treats must be tested and have a certificate of analysis prepared by an independent testing laboratory as required 219

in s. 581.217(7), F.S. 220

(b) Prior to a feed master registrant engaging in the distribution of pet food, pet treats, specialty pet food and 221

specialty pet treats containing hemp extract, the registrant shall submit a waste disposal plan. The plan shall include 222

a method of disposal by a chemical or mechanical process that will destroy the pet food, pet treats, specialty pet food 223

and specialty pet treats. 224

delta-9-tetrahydrocannabinol concentration on a dry weight basis. 226

(d) Pet food, pet treats, specialty pet food and specialty pet treat products having a total delta-9-227

tetrahydrocannabinol concentration that exceeds 0.3% on a dry weight basis, shall be detained pursuant to s. 228

580.111, F.S. Those products having a total delta-9-tetrahydrocannabinol concentration that exceeds 0.3% on a dry 229

weight basis which have been detained pursuant to s. 580.111, F.S., shall not be further subdivided or renumbered 230

such that the integrity of the lot for identification is not maintained. The manufacturer or distributor shall not dispose 231

of the pet food, pet treats, specialty pet food and specialty pet treats in any manner until written permission is given 232

by the Department or a court of competent jurisdiction. 233

(e) Upon receipt of written permission by the Department or a court of competent jurisdiction, the pet food, pet 234

treats, specialty pet food and specialty pet treats shall be disposed of in accordance with a waste disposal plan or in 235

the manner provided for by a court of competent jurisdiction. Upon destruction of the product, the manufacturer or 236

distributor shall notify the Department via FDACS-XXXXX xx/xx, incorporated herein by reference and available 237

online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. 238

(f) Any byproduct as a result of processing which contains a total delta-9 tetrahydrocannabinol concentration 239

exceeding 0.3% on a dry weight basis must be properly destroyed by the manufacturer or distributor pursuant to the 240

waste disposal plan. 241

(5) through (8) renumbered (6) through (9) No change. 242

Rulemaking Authority 570.07(23), 580.036(2), 580.065 581.217(12)(b) FS. Law Implemented 580.036(2), 580.051, 243

580.065, 580.071, 580.091, 580.111, 580.121, 580.131, 581.217(7)(a) FS. History–New 12-30-70, 5-14-85, Formerly 5E-3.03, 244

Amended 3-4-87, 6-1-95, 11-14-01, 8-31-06, . 245

5E-3.004 Ingredient Statement. 246

(1) Each ingredient shall be specifically named (the names and definitions identified in “Official Publication 247

20012019” published by the Association of American Feed Control Officials shall be used as the common or usual 248

names unless the Department of Agriculture and Consumer Services designates otherwise by rule), except that 249

collective terms for a group of ingredients which perform a similar function may be used on labels for all 250

commercial feed except horse feed. Collective terms recognize a general classification of ingredient origin but do 251

not imply equivalent nutritional values. The following collective terms may be used in lieu of each ingredient term 252

provided that only those ingredients defined by Association of American Feed Control Officials within each 253

collective term are included: 254

Animal Protein Products 255

Grain Products 256

Plant Protein Products 257

Processed Grain By-Products 258

Forage Products 259

Roughage Products 260

Molasses Products 261

(a) through (b) No change. 262

(2) through (6) No change. 263

(7) Pet food, pet treats, specialty pet food and specialty pet treat products may contain hemp extract as defined 264

by s. 581.217(3), F.S. provided the product is not a drug as defined in s. 580.031(9), F.S. 265

(8)(7) “Official Publication 20192001” published by The Association of American Feed Control Officials is 266

hereby incorporated by reference. Copies may be obtained from AAFCO 1800 South Oak Street, Suite 100, 267

Champaign, Illinois 61820 or http://www.aafco.org/publications Assistant Secretary-Treasurer, P. O. Box 478, 268

Oxford, IN 47971. 269

Rulemaking Authority 570.07(23), 580.036(2) FS. Law Implemented 580.051(1)(f) , 581.217(3)(e) FS. History–New 12-30-270

70, 4-1-76, Formerly 5E-3.04, Amended 6-1-95, 11-14-01, . 271

5E-3.005 Labels. 272

(1) through (3) No change. 273

(4) Pet food, pet treats, specialty pet food and specialty pet treats consisting of or containing hemp extract must 274

be labeled as required in s. 581.217(7), F.S, and must declare the number of milligrams of cannabidiol (CBD) per 275

serving. The serving size must be defined on the label. 276

(5) The label and labeling for pet food, pet treats, specialty pet food and specialty pet treats consisting of or 277

containing hemp extract shall not contain claims indicating the product is intended for diagnosis, cure, mitigation, 278

treatment, or prevention of disease rendering it a drug as defined by s. 580.031(9), F.S. 279

(6) Pet food, pet treats, specialty pet food and specialty pet treats consisting of or containing hemp extract shall 280

be labeled “Not for human consumption.” 281

Rulemaking Authority 570.07(23), 580.036(2) FS. Law Implemented 580.051, 580.081, 580.112, 581.217(7) FS. History–282

New 12-30-70, Formerly 5E-3.05, Amended 3-5-89, 9-19-94, 6-1-95, . 283

HEMP EXTRACT IN FOOD 284

5K-4.034, Florida Administrative Code 285

5K-4.034 Hemp Extract in Food 286

(1) Products. Hemp Extracts intended to be included in or as Food as defined in s. 500.03, F.S., are subject to 287

the requirements of Chapter 500, F.S., and Rules 5K-4.002, .004, .020, .021, .035, F.A.C., and this rule. 288

(2) Definitions: 289

(a) “Approved Source” as it relates to Food consisting of or containing Hemp Extract means Food 290

manufactured, processed, packaged, labeled, or held in this state under sanitary conditions as demonstrated by 291

meeting the Department’s inspection requirements or evidence the source is in compliance with a foreign, federal, 292

state, local, territorial, or tribal jurisdiction’s food safety regulatory inspection program. 293

(b) “Batch Number” or “Lot Number” means the Food produced during a period of time under similar 294

conditions and identified by a specific code that allows traceability. 295

the basis of tests or other information showing that the product, until that date, under the conditions of handling, 297

storage, preparation, and use per label directions, will when consumed, contain not less than the quantity of each 298

ingredient as set forth on its label. 299

(d) “Hemp” is defined in s. 581.217(3)(d), F.S. 300

(e) “Hemp Extract” is defined in s. 581.217(3)(e), F.S. Hemp Extract does not include any material, compound, 301

mixture or preparation that contains any quantity of Synthetic Cannabinoids as defined in s. 893.03(1)(c)190., F.S. 302

(f) “Hemp Food Establishment” means an establishment, as defined in s. 500.03(p), F.S., manufacturing, 303

processing, packing, holding, preparing, or selling Food consisting of or containing Hemp Extract at wholesale or 304

retail. 305

(g) “Ingestion” means the process of taking Food into the body through the mouth and into the gastrointestinal 306

tract through eating or drinking. 307

(h) “Waste disposal plan” means a detailed plan outlining the chemical or mechanical process the establishment 308

will use to destroy products containing hemp extract. 309

(3) Permit and Fees. 310

(a) Hemp Food Establishments shall obtain a food permit as required in Rule 5K-4.020, F.A.C., and shall pay an 311

annual fee of $650. 312

(b) Hemp Food Establishments must submit to the Department a Waste disposal plan prior to manufacturing, 313

processing, packing, holding, preparing, or selling Food constituting of or containing Hemp Extract. 314

(4) Requirements. 315

(a) Food consisting of or containing Hemp or Hemp Extract must be obtained from an Approved Source. The 316

responsible party (as declared on the product label) shall provide to the Department, upon request, a valid food 317

license/permit and the most recent food safety inspection report from the Approved Source. 318

(b) Hemp Extract intended for human ingestion whether directly or through combination with other Food 319

products must originate from a crop intended to be used in the food supply chain. 320

or sold under the Cottage Food Operations Law in s. 500.80, F.S. 322

(d) Food which contains Hemp Extract and alcohol, other than Candies or Confections as defined in Rule 5K-323

4.0010, F.A.C., are subject to the requirements of this rule and the Beverage Law. 324

(e) Hemp intended for bodily application is not a Food and is subject to the Florida Drug and Cosmetic Act. 325

(f) Food containing or consisting of Hemp Extract must be stored and transported at or below room temperature. 326

If a Food is considered a Potentially Hazardous Food (PHF) or a Food requiring Time and Temperature Control for 327

Safety (TCS Food) as defined in 5K-4.0010, F.A.C., it must be stored in accordance with Rule 5K-4.002, F.A.C. All 328

Food products containing or consisting of Hemp Extract must be packaged in containers eliminating the exposure to 329

light to prevent degradation of the Cannabinoids. 330

(g) Food consisting of or containing Hemp Extract shall not contain a total delta-9 tetrahydrocannabinol 331

concentration of more than 0.3% on a dry weight basis. 332

(5) Contaminants. In addition to the requirements listed in Chapter 500, F.S., and Rule 5K-4.002, F.A.C., Food 333

consisting of or containing Hemp Extract shall be considered adulterated pursuant to s. 500.10(1)(a), F.S., if 334

Contaminants are detected at levels greater than those listed in this rule. 335

(a) Pesticide Limits. The following list of contaminants does not constitute 336

authorization to use or apply any of the following during hemp cultivation or processing. 337

1. Abamectin, 20 parts per billion. 338

2. Acephate, 20 parts per billion. 339

3. Acequinocyl, 20 parts per billion. 340

4. Acetamiprid, 10 parts per billion. 341

5. Aldicarb, 10 parts per billion. 342

6. Azoxystrobin, 10 parts per billion. 343

7. Bifenazate, 100 parts per billion. 344

8. Chlorfenapyr, 10 parts per billion. 345

9. Chlorpyrifos, 20 parts per billion. 346

10. Clofentezine, 40 parts per billion. 347

11. Coumaphos, 10 parts per billion. 348

12. Cyfluthrin, 10 parts per billion. 349

13. Cypermethrin, 500 parts per billion. 350

14. Daminozide, 10 parts per billion. 351

15. DDVP (Dichlorvos), 20 parts per billion. 352

16. Diazinon, 10 parts per billion. 353

17. Dimethoate, 10 parts per billion. 354

18. Dimethomorph, 10 parts per billion. 355

19. Ethoprop(hos), 10 parts per billion. 356

20. Etofenprox, 10 parts per billion. 357

21. Etoxazole, 10 parts per billion. 358

22. Fenhexamid, 80 parts per billion. 359

23. Fenoxycarb, 10 parts per billion. 360

24. Fenpyroximate, 100 parts per billion. 361

25. Fipronil, 10 parts per billion. 362

26. Flonicamid, 100 parts per billion. 363

27. Fludioxonil, 20 parts per billion. 364

28. Hexythiazox, 100 parts per billion. 365

29. Imazalil, 10 parts per billion. 366

30. Imidacloprid, 20 parts per billion. 367

31. Kresoxim-methyl, 20 parts per billion. 368

32. Malathion, 10 parts per billion. 369

33. Metalaxyl, 10 parts per billion. 370

34. Methiocarb, 10 parts per billion. 371

35. Methomyl, 10 parts per billion. 372

36. Methyl parathion, 10 parts per billion. 373

37. Mevinphos, 10 parts per billion. 374

38. Myclobutanil, 20 parts per billion. 375

39. Naled, 10 parts per billion. 376

40. Oxamyl, 26 parts per billion. 377

41. Paclobutrazol, 10 parts per billion. 378

42. Pentachloronitrobenzene, 30 parts per billion. 379

43. Permethrin, 20 parts per billion. 380

44. Phosmet, 20 parts per billion. 381

45. Piperonyl butoxide, 3,000 parts per billion. 382

46. Prallethrin, 20 parts per billion. 383

47. Propiconazole, 20 parts per billion. 384

48. Propoxur, 20 parts per billion. 385

49. Pyrethrins, 500 parts per billion. 386

50. Pyridaben, 20 parts per billion. 387

51. Spinetoram, 40 parts per billion. 388

52. Spinosad A, 20 parts per billion. 389

53. Spinosad D, 20 parts per billion. 390

54. Spiromesifen, 30 parts per billion. 391

55. Spirotetramat, 20 parts per billion. 392

56. Spiroxamine, 10 parts per billion. 393

57. Tebuconazole, 10 parts per billion. 394

58. Thiacloprid, 10 parts per billion. 395

59. Thiamethoxam, 10 parts per billion. 396

60. Trifloxystrobin, 20 parts per billion. 397

(b) Residual Solvent Limits. Residual Solvent limits listed in the United States Pharmacopeia, USP 40, (467), 398

hereby incorporated by reference and available online at 399

http://www.flrules.org/Gateway/reference.asp?No=RefXXXX. 400

1. Cadmium, 0.5 micrograms/gram. 402

2. Lead, 0.5 micrograms/gram. 403

3. Arsenic, 1.5 micrograms/gram. 404

4. Mercury, 3.0 micrograms/gram. 405

(d) Biological Limits. 406

1. Shiga toxin-producing Escherichia coli (STEC E. coli) and other pathogenic E. coli, none present. 407

2. Listeria monocytogenes, none present. 408

3. Salmonella, none present. 409

(e) Mycotoxin Limits. 410

1. Total Aflatoxin (B1, B2, G1, G2), 20 parts per billion. 411

2. Ochratoxin, 20 parts per billion. 412

(f) Cannabinoid Limits. Total delta-9 tetrahydrocannabinol concentration shall not exceed 0.3% on a dry weight 413

basis. 414

(g) If a testing sample is found to contain levels of any pathogen, toxicant, residual solvent, metal, or pesticide 415

not enumerated in this rule or by Florida law the Food shall be considered adulterated. 416

(6) Labeling. 417

(a) Food consisting of or containing Hemp Extract must be labeled as required by Chapter 500, F.S., s. 418

581.217(7), F.S., and 21 CFR Part 101, as incorporated by reference in Section 5K-4.002(4), F.A.C., and must 419

declare the number of milligrams of cannabidiol (CBD) per serving. The serving size shall be displayed on the 420

nutrition facts label of the product. 421

(b) The label and advertisement shall not contain claims indicating the product is intended for diagnosis, cure, 422

mitigation, treatment, or prevention of disease, rendering it a drug as defined in 21 U.S.C. 321(g)(1). Pursuant to s. 423

500.03(1)(n)4., F.S., such articles are not considered Food. 424

(7) Disposal. 425

(a) Laboratory samples found to contain more than a total delta-9 tetrahydrocannabinol concentration of 0.3% 426

on a dry weight basis shall be disposed of in accordance with 21 CFR 1317, which is hereby incorporated by 427

reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. 428

(b) Food containing a total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% on a dry weight basis 429

shall be detained pursuant to s. 500.172, F.S. Food containing a total delta-9 tetrahydrocannabinol concentration that 430

exceeds 0.3% on a dry weight basis which have been detained pursuant to s. 500.172, F.S. shall not be further 431

subdivided or renumbered such that the integrity of the lot is not maintained. The Hemp Food Establishment shall 432

not shall not dispose of the Food in any manner until written permission is given by the Department or a court of 433

competent jurisdiction. 434

exceeding 0.3% on a dry weight basis must be destroyed by the Hemp Food Establishment in accordance with the 436

Waste disposal plan. 437

(d) Upon receipt of written permission by the Department or a court of competent jurisdiction, the Food shall be 438

disposed of in accordance with the Waste disposal plan or in the manner provided for by a court of competent 439

jurisdiction. Upon destruction of the product, the Hemp Food Establishment shall notify the Department by 440

submitting FDACS-XXXXX xx/xx, incorporated herein by reference and available online at 441

https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. 442

(8) Penalties. Violations of this rule will be evaluated, and penalties imposed in accordance with Rule 5K-443

4.035, F.A.C. Labeling violations of s. 581.217(7), F.S., shall be deemed Tier I major violations under Rule 5K-444

4.035, F.A.C. 445

Rulemaking Authority 570.07(23), 500.09, FS. Law Implemented 581.217, 500.03, 500.04, 500.09, 500.10, 446

500.11, 500.12, 500.13, 500.172, FS. 447

448

HEMP EXTRACT IN DAIRY PRODUCTS AND FROZEN DESSERTS 449

5K-10.006, Florida Administrative Code 450

5K-10.006 Hemp Extract in Dairy Products and Frozen Desserts 451

(1) Products. Milk, Milk Products, and Frozen Desserts containing Hemp or Hemp Extract are subject to the 452

requirements of Chapter 502, F.S., and Chapter 5K-10, F.A.C., in addition to the requirements of this rule. Grade 453

“A” milk and milk products to which Hemp Extract has been added shall be considered “Substitute Milk” or 454

“Substitute Milk Products” as defined in Chapter 502, F.S. In addition to the requirements in Section 502.165 F.S., 455

Substitute Milk and Substitute Milk Products containing Hemp Extract are subject to the requirements of Chapter 456

5K-10, F.A.C. 457

(2) Definitions: 458

(a) “Approved Source” as it relates to Substitute Milk, Substitute Milk Products, and Frozen Desserts 459

containing Hemp Extract means Substitute Milk, Substitute Milk Products, and Frozen Desserts manufactured, 460

processed, packaged, labeled, or held in this state under sanitary conditions as demonstrated by meeting the 461

Department’s inspection requirements or evidence the source is in compliance with a foreign, federal, state, local, 462

territorial, or tribal jurisdiction’s dairy sanitation regulatory inspection program. 463

(b) “Batch Number” or “Lot Number” means the Substitute Milk, Substitute Milk Products, and Frozen 464

Desserts containing Hemp Extract produced during a period of time under similar conditions and identified by a 465

specific code that allows traceability. 466

the basis of tests or other information showing that the product, until that date, under the conditions of handling, 468

storage, preparation, and use per label directions, will when consumed, contain not less than the quantity of each 469

ingredient as set forth on its label. 470

(d) “Hemp” is defined in s. 581.217(3)(d), F.S. 471

(e) “Hemp Extract” is defined in s. 581.217(3)(e), F.S. Hemp Extract does not include any material, compound, 472

mixture or preparation that contains any quantity of Synthetic Cannabinoids as defined in s. 893.03(1)(c)190., F.S. 473

(f) “Hemp Frozen Dessert Manufacturer” means a person who manufactures, processes, converts, partially 474

freezes, or freezes any mix or frozen dessert containing Hemp Extract for distribution or sale. 475

(g) “Hemp Substitute Milk Manufacturer” means any place, premises, or establishment where Substitute Milk 476

containing Hemp Extract is collected, handled, processed, stored, pasteurized, ultra-pasteurized, aseptically 477

processed and packaged, retort processed after packaging, condensed, dried, packaged, bottled, or prepared for 478

distribution at wholesale. 479

(h) “Hemp Substitute Milk Product Manufacturer” means any place, premises, or establishment where 480

Substitute Milk Products containing Hemp Extract is collected, handled, processed, stored, pasteurized, ultra-481

pasteurized, aseptically processed and packaged, retort processed after packaging, condensed, dried, packaged, 482

bottled, or prepared for distribution at wholesale. 483

(i) “Ingestion” means the process of taking food into the body through the mouth and into the gastrointestinal 484

tract through eating or drinking. 485

(j) “Waste disposal plan” means a detailed plan outlining the chemical or mechanical process the manufacturer 486

will use to destroy products containing Hemp Extract. 487

(3) Permits and Fees. 488

(a) Hemp Substitute Milk, Hemp Substitute Milk Products, and Hemp Frozen Dessert Manufacturers shall 489

obtain a permit and pay the applicable fee required in Rule 5K-10.002, F.A.C. 490

(b) Manufacturers must submit to the Department a Waste disposal plan prior to manufacturing, processing, 491

packing, holding, preparing, or selling Hemp Substitute Milk, Hemp Substitute Milk Products, or Frozen Desserts 492

containing Hemp Extract. 493

(4) Requirements. 494

(a) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp Extract must be obtained 495

from an Approved Source. The responsible party (as declared on the product label) shall provide to the Department, 496

upon request, a valid dairy or food safety license/permit and the most recent dairy or food safety inspection report 497

from the Approved Source. 498

(b) Hemp Extract intended for human ingestion whether directly or through Substitute Milk, Substitute Milk 499

Products, or Frozen Dessert products must originate from a crop intended to be used in the food supply chain. 500

subject to the requirements of this rule and the Beverage Law. 502

(d) Hemp intended for bodily application is not a Substitute Milk, Substitute Milk Product, or Frozen Dessert 503

and is subject to the Florida Drug and Cosmetic Act. 504

(e) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp Extract must be stored and 505

transported in accordance with Chapter 5K-10, F.A.C. Substitute Milk, Substitute Milk Products, and Frozen 506

Desserts containing Hemp Extract must be packaged in containers eliminating the exposure to light to prevent 507

degradation of the Cannabinoids. 508

(f) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp Extract shall not contain a 509

total delta-9 tetrahydrocannabinol concentration of more than 0.3% on a dry weight basis. 510

(5) Contaminants. In addition to the requirements listed in Chapter 502, F.S., and Rule 5K-10.004, Substitute 511

Milk, Substitute Milk Products, and Frozen Desserts containing Hemp Extract shall be considered adulterated 512

pursuant to s. 502.181(2), F.S., if contaminants are detected at levels greater than those listed in this rule. 513

(a) Pesticide Limits. The following list of contaminants does not constitute authorization to use or apply any of 514

the following during hemp cultivation or processing. 515

1. Abamectin, 20 parts per billion. 516

2. Acephate, 20 parts per billion. 517

3. Acequinocyl, 20 parts per billion. 518

4. Acetamiprid, 10 parts per billion. 519

5. Aldicarb, 10 parts per billion. 520

6. Azoxystrobin, 10 parts per billion. 521

7. Bifenazate, 100 parts per billion. 522

8. Chlorfenapyr, 10 parts per billion. 523

9. Chlorpyrifos, 20 parts per billion. 524

10. Clofentezine, 40 parts per billion. 525

11. Coumaphos, 10 parts per billion. 526

12. Cyfluthrin, 10 parts per billion. 527

13. Cypermethrin, 500 parts per billion. 528

14. Daminozide, 10 parts per billion. 529

15. DDVP (Dichlorvos), 20 parts per billion. 530

16. Diazinon, 10 parts per billion. 531

17. Dimethoate, 10 parts per billion. 532

18. Dimethomorph, 10 parts per billion. 533

19. Ethoprop(hos), 10 parts per billion. 534

20. Etofenprox, 10 parts per billion. 535

21. Etoxazole, 10 parts per billion. 536

22. Fenhexamid, 80 parts per billion. 537

23. Fenoxycarb, 10 parts per billion. 538

24. Fenpyroximate, 100 parts per billion. 539

25. Fipronil, 10 parts per billion. 540

26. Flonicamid, 100 parts per billion. 541

27. Fludioxonil, 20 parts per billion. 542

28. Hexythiazox, 100 parts per billion. 543

29. Imazalil, 10 parts per billion. 544

30. Imidacloprid, 20 parts per billion. 545

31. Kresoxim-methyl, 20 parts per billion. 546

32. Malathion, 10 parts per billion. 547

33. Metalaxyl, 10 parts per billion. 548

34. Methiocarb, 10 parts per billion. 549

35. Methomyl, 10 parts per billion. 550

36. Methyl parathion, 10 parts per billion. 551

37. Mevinphos, 10 parts per billion. 552

38. Myclobutanil, 20 parts per billion. 553

39. Naled, 10 parts per billion. 554

40. Oxamyl, 26 parts per billion. 555

41. Paclobutrazol, 10 parts per billion. 556

42. Pentachloronitrobenzene, 30 parts per billion. 557

43. Permethrin, 20 parts per billion. 558

44. Phosmet, 20 parts per billion. 559

45. Piperonyl butoxide, 3,000 parts per billion. 560

46. Prallethrin, 20 parts per billion. 561

47. Propiconazole, 20 parts per billion. 562

48. Propoxur, 20 parts per billion. 563

49. Pyrethrins, 500 parts per billion. 564

50. Pyridaben, 20 parts per billion. 565

51. Spinetoram, 40 parts per billion. 566

52. Spinosad A, 20 parts per billion. 567

53. Spinosad D, 20 parts per billion. 568

54. Spiromesifen, 30 parts per billion. 569

55. Spirotetramat, 20 parts per billion. 570

56. Spiroxamine, 10 parts per billion. 571

57. Tebuconazole, 10 parts per billion. 572

58. Thiacloprid, 10 parts per billion. 573

59. Thiamethoxam, 10 parts per billion. 574

60. Trifloxystrobin, 20 parts per billion. 575

(b) Residual Solvent Limits. Residual Solvent limits listed in the United States Pharmacopeia, USP 40, (467), 576

which is hereby incorporated by reference and available online at 577

http://www.flrules.org/Gateway/reference.asp?No=RefXXXX. 578

1. Cadmium, 0.5 micrograms/gram 580

2. Lead, 0.5 micrograms/gram 581

3. Arsenic, 1.5 micrograms/gram 582

4. Mercury, 3.0 microgram/gram 583

(d) Biological Limits. 584

1. Shiga toxin-producing Escherichia coli (STEC E. coli) and other pathogenic E. coli, none present. 585

2. Listeria monocytogenes, none present. 586

3. Salmonella, none present. 587

(e) Mycotoxins Limits. 588

1. Total Aflatoxin (B1, B2, G1, G2), 20 parts per billion. 589

2. Ochratoxin, 20 parts per billion. 590

(f) Cannabinoid Limits. Total delta-9 tetrahydrocannabinol concentration shall not exceed 0.3% on a dry weight 591

basis. 592

(g) If a testing sample is found to contain levels of any pathogen, toxicant, residual solvent, metal, or pesticide 593

not enumerated in this rule or by Florida law the Substitute Milk, Substitute Milk Product, or Frozen Dessert 594

containing Hemp Extract shall be considered adulterated. 595

(6) Labeling. 596

(a) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp Extract must be labeled in 597

accordance with Chapter 502 F.S., s. 581.217(7), F.S., 21 CFR 101, and must include the number of milligrams of 598

cannabidiol (CBD) per serving. The serving size shall be displayed on the nutrition facts label of the product. 599

(b) The label and advertisement shall not contain claims indicating the product is intended for diagnosis, cure, 600

mitigation, treatment, or prevention of disease, rendering it a drug as defined in 21 U.S.C. 321(g)(1). 601

(7) Disposal. 602

(a) Laboratory samples found to contain more than a total delta-9 tetrahydrocannabinol concentration of 0.3% 603

on a dry weight basis shall be disposed of in accordance with 21 CFR 1317, which is hereby incorporated by 604

reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. 605

(b) Substitute Milk, Substitute Milk Products, or Frozen Desserts containing a total delta-9 606

tetrahydrocannabinol concentration that exceeds 0.3% on a dry weight basis shall be detained pursuant to s. 502.014, 607

F.S. Substitute Milk, Substitute Milk Products, or Frozen Desserts containing a total delta-9 tetrahydrocannabinol 608

concentration that exceeds 0.3% on a dry weight basis which have been detained pursuant to 502.014, F.S., shall not 609

be further subdivided or renumbered such that the integrity of the lot for identification is not maintained. The 610

permittee shall not shall not dispose of the Substitute Milk, Substitute Milk Products, or Frozen Desserts containing 611

Hemp Extract in any manner until written permission is given by the Department or a court of competent 612

jurisdiction. 613

exceeding 0.3% on a dry weight basis must be destroyed by the permittee in accordance with the Waste disposal 615

plan. 616

(d) Upon receipt of written permission by the Department or a court of competent jurisdiction, the Substitute 617

Milk, Substitute Milk Products, or Frozen Desserts shall be disposed of in accordance with the waste disposal plan 618

or in the manner provided for by a court of competent jurisdiction. Upon destruction of the product, the permittee 619

shall notify the Department by submitting FDACS-XXXXX xx/xx, incorporated herein by reference and available 620

online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. 621

(8) Penalties. Violations of this rule will be evaluated, and penalties imposed in accordance with Rule 5K-622

10.005, F.A.C. Labeling violations of s. 581.217(7), F.S. shall be deemed Tier I major violations under Rule 5K-623

10.005(b)1., F.A.C. 624

Rulemaking Authority 502.014, 502.053, 570.07(23), FS. Law Implemented 502.014, 502.032, 502.053, 625

502.091, 502.165, 502.231, 581.217(7), FS. History–New 9-21-67,