Definitions, Permits and Fees, Inspection and Reinspection, Permitting Requirements, Guidelines for Imposing Administrative Penalties
DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES
RULE NOS.:RULE TITLES:
5K-11.001Definitions
5K-11.002Permits and Fees
5K-11.003Inspection and Reinspection
5K-11.004Permitting Requirements
5K-11.005Guidelines for Imposing Administrative Penalties
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 45 No. 236, December 6, 2019 issue of the Florida Administrative Register.
5K-11.001 Definitions.
For the purposes of this rule chapter, the definitions in s. Section 500.03, F.S., and the following shall apply:
(1) Change in Ownership means:
(a) An event in which the permittee sells or otherwise transfers its ownership to a different person as evidenced by a change in federal employer identification number or taxpayer identification number; or
(b) An event in which 51 percent or more of the ownership, shares, membership, or controlling interest of a permittee is in any manner transferred or otherwise assigned. This paragraph does not apply to a permit held by a person that is publicly traded on a recognized stock exchange. A change solely in the management or board of directors is not a change of ownership.
(2)(1) No change.
(3)(2) Edibles is defined as in s. Section 381.986(1)(d), F.S., to mean commercially produced food items made with Marijuana Oil, but no other form of marijuana, that are produced and dispensed by a Medical Marijuana Treatment Center.
(4)(3) Marijuana Oil means oil derived from Low-THC Cannabis as defined in s. Section 381.986(1)(e), F.S., or Marijuana as defined in s. Section 381.986(1)(f), F.S.
(5)(4) Medical Marijuana Treatment Centers (MMTC) are licensed by the Florida Department of Health as provided in s. Subsection 381.986(8), F.S., and are defined as in Art. X, § 29(b)(5), Fla. Const., to mean an entity that acquires, cultivates, possesses, processes (including development of related products such as food, tinctures, aerosols, oils, or ointments), transfers, transports, sells, distributes, dispenses, or administers marijuana, products containing marijuana, related supplies, or educational materials to qualifying patients or their caregivers.
Rulemaking Authority 500.09, 570.07(23), FS. Law Implemented 381.986, 500.03, 500.12, FS. History–New __________.
5K-11.002 – Permits and Fees.
(1) Pursuant to s. Subsection 381.986(8)(e)8., F.S., MMTCs producing or manufacturing Edibles are required to be permitted as food establishments and are subject to the requirements of Chapter 500, F.S., and this rule chapter.
(2) MMTCs are strongly encouraged to Prior to applying for a food permit pursuant to this rule chapter, an MMTC shall undergo a plan review with the Department prior to applying for a food permit pursuant to this rule chapter, for the purpose of evaluating whether proposed construction or remodeling plans conform to current requirements established in Chapter 500, F.S., and this rule chapter including existing regulations adopted by reference. To MMTCs may request a plan review, an MMTC shall by submitting submit a completed Medical Marijuana Treatment Center Plan Review Application, FDACS- 14222 14032 (Rev. 11/18 01/19) incorporated by reference in Rule 5K-4.004(8)(a), F.A.C., and any applicable fees as outlined in paragraph 5K-4.004(8)(9)(b), F.A.C. An MMTC shall not apply for a food permit unless plans are approved by the Department. The Medical Marijuana Treatment Center Plan Review Application, FDACS- 14032 (Rev. 01/19), is incorporated by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX.
(3) Initial Permits. Prior to producing or manufacturing Edibles, an MMTC must obtain a food permit pursuant to Chapter 500, F.S., and in accordance with this rule. To apply for a food permit an MMTC shall:
(a) Complete a plan review pursuant to Subsection (2) and have approved plans by the Department;
(a)(b) Submit to the Department a completed Medical Marijuana Treatment Center Food Permit Application, FDACS-14031, (Rev. 01/19), which is adopted and incorporated by reference and available as indicated in the form and online at http://www.flrules.org/Gateway/reference.asp?No=Ref-xxxx;
(c) through (d) redesignated (b) through (c) No change.
(d)(e) Demonstrate through an initial inspection conducted by the Department that the facility where Edibles will be produced or manufactured meets inspection requirements established in Chapter 500, F.S., and Paragraphs 5K-4.002(1)(c) - (e), Subsection 5K-4.002(2), and Rule 5K-4.004 Rule Chapter 5K-4, F.A.C.
(4) Permit renewal. Food permits must be renewed by the MMTC annually as prescribed in Subsection (3), with the exception of the plan review in Paragraph (a) and initial inspection in Paragraph (3)(d)(e).
(5) Prior to implementation, MMTCs shall notify the Department in writing at foodinsp@freshfromflorida.com, of any changes or additions to: food products to be produced or manufactured.; equipment to be used; or methods of processing. The Department will review the change to determine whether additional action is required by the MMTC to remain in compliance with Chapter 500, F.S., and this rule chapter. The Department shall notify the MMTC and schedule an inspection if further action is necessary.
(6) through (7) No change.
(8) Change in Ownership or Physical Location of an MMTC. An MMTC must complete the application requirements and receive a new food permit prior to manufacturing or producing edibles in a new location or after a Cchange in Oownership. Food permits are not transferable from one person or physical location to another.
(9) No change.
5K-11.003 Inspections and Reinspections.
(1) No change.
(2) Reinspections. Any reinspection required for an MMTC shall be charged a fee of $135.00 for recovery of the cost incurred to provide each reinspection. For the purposes of this section, a reinspection refers to any inspection conducted for the purpose of verifying compliance with Chapter 500, F.S., or the rules promulgated thereunder, or this rule chapter following a previous inspection that requires a reinspection. Such inspection shall be indicated by issuance of an inspection report listing conditions that are not in compliance and which, when viewed as a whole, are more likely to contribute to food contamination, illnesses, or environmental health hazards.
Rulemaking Authority 500.09, 500.12, 570.07(23) FS. Law Implemented 500.12, 500.147, FS. History–New ______.
5K-11.004 Permitting Requirements.
(1) Paragraphs 5K-4.002(1)(c) - (e), Subsection 5K-4.002(2), and Rule 5K-4.004, F.A.C., are incorporated by reference and apply to MMTCs operating as food establishments.
(2) through (4) renumbered (1) through (3) No change.
(5) Any person violating this rule chapter shall be subject to the injunction procedures of Section 500.171, F.S., and to the penalties provided in Sections 500.121, 500.172, 500.173, 500.174, and 500.177, F.S.
Rulemaking Authority 500.09, 570.07(23), FS. Law Implemented 500.04, 500.09, 500.10, 500.12, 500.80, FS. History–New ______________.
5K-11.005 Guidelines for Imposing Administrative Penalties.
(1) No change.
(2) Any person violating this rule chapter shall be subject to the injunction procedures of s. 500.171, F.S., and to the penalties provided in ss. 500.121, 500.172, 500.173, 500.174, and 500.177, F.S.
(3)(2) The Department will enforce compliance with Chapters 500, F.S., and this rule chapter by issuing an administrative complaint, a stop-sale order, stop-use order, release order, destruction order, notice of non-compliance, permit suspension or revocation, or an immediate final order for violations of Chapters 500, F.S., and this rule chapter.
(4)(3) Stop-Sale, or Stop-Use, Release, or Destruction Orders. The Department shall issue a Stop-Sale, or Stop-Use, Release, and/or Destruction Order FDACS-14215, (Rev. (04/19 03/18), as provided in s. Section 500.172, F.S., whenever necessary to effectuate the statutory duties of the Department in the interest of public health, safety, and welfare and as necessary to promote the safety of any food product, food-processing equipment, or areas within an entity operating as a food establishment in Florida. A Stop-Sale, or Stop-Use, Release, and/or Destruction Order 14215, (Rev. 04/19 03/18), will be used to give notice that such a product, processing equipment or area is, or is suspected of, failing to comply with the requirements of Chapter 500, F.S., or this rule chapter, and shall prohibit the removal, use, or disposal of such item. The Stop-Sale, or Stop -Use, Release, and/or Destruction Order is incorporated by reference in Rule 5K-4.035, F.A.C.
(4) through (5) renumbered (5) through (6) No change.
(7) (6) Aggravating and Mitigating Factors. The Department will consider aggravating and mitigating factors in determining penalties for violations of Chapters 500, F.S., and this rule chapter. The factors shall be applied against each single count of the listed violation.
(a) Aggravating Factors:
1. through 3. No change.
4. The length of time the business has been in operation and the violation history over the past three years.
5. through 10. No change.
(b) No change.
(7) through (8) renumbered (8) through (9) No change.
(10)(9) Penalties.
(a) Minor Violation. Any Department investigation or inspection which reveals violations of this Rule Chapter in which the Department determines that the violator was unaware of the rule or unclear as to how to comply with it will result in the issuance of a Notice of Non-Compliance as the Department’s first response to the violation. For the purposes of this rule, the following violations shall be considered minor and shall result in the issuance of a notice of noncompliance:
1. through 3. No change.
4. Failure to notify the Department in writing of any changes or additions to food products to be produced or manufactured, equipment to be used, or methods of processing prior to implementation in accordance to Subsection 5K-11.002(5)(4), F.A.C.
(b) Major Violations. Any violation of Chapters 500, F.S., or this rule chapter that may result in economic or physical harm to a person or may adversely affect the public health, safety, or welfare or creates a significant threat of such harm shall be considered a major violation.
1. Tier I. Tier I major violations shall result in the issuance of a stop-sale order, and/or stop-use order, and/or destruction order. For the purposes of this rule, the following violations shall be considered Tier I violations:
a. through l. No change.
2. Tier II. Tier II violations shall result in the issuance of a stop-sale, stop-use order, destruction order, and/or an administrative fine of $500 up to the statutory maximum. Aggravating factors, as defined in paragraph (6)(a) of this rule, shall warrant the adjustment of the fine upward per violation per aggravating factor and mitigating factors, as defined in paragraph (6)(b) of this rule, shall warrant the adjustment of the fine downward per violation per mitigating factor, but no fine shall exceed the statutory maximum as outlined in s. Section 570.971, F.S., as applicable. If, three years after the day of the last violation under Chapters 500, F.S., or this rule chapter, no new violation has occurred, all previous fines shall be disregarded when administering a fine for the next violation. For the purposes of this rule, the following violations shall be considered Tier II violations:
a. through f. No change.
(10) through (11) renumbered (11) through (12) No change.
