Section 381.986, F.S., requires Medical Marijuana Treatment Centers (MMTC) electing to produce or manufacture edibles to hold a food permit pursuant to Chapter 500, F.S. The purpose of this rulemaking is to adopt a process by which MMTCs may be ...

 

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

Division of Food Safety

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

PURPOSE AND EFFECT: Section 381.986, F.S., requires Medical Marijuana Treatment Centers (MMTC) electing to produce or manufacture edibles to hold a food permit pursuant to Chapter 500, F.S. The purpose of this rulemaking is to adopt a process by which MMTCs may be permitted to process and manufacture edibles; define applicable terms and food permitting requirements; and establish guidelines for administering penalties for violations of the proposed rule chapter and Chapter 500, F.S.

SUMMARY: This proposed rule will adopt food permitting requirements for Medical Marijuana Treatment Centers (MMTC) electing to produce and manufacture edibles; define terms; outline food permitting and inspection requirements; and establish guidelines for imposing administrative penalties.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The department examined the number of MMTCs currently licensed by the Department of Health and the amount of fees the department proposes to charge MMTCs that wish to produce and manufacture edibles. Based on this information, the department determined there will be no adverse impact to small businesses and the potential regulatory costs of the proposed rule chapter does not exceed any of the criteria established in Section 120.541(2)(a), F.S. Additionally, no interested party submitted additional information regarding the economic impact.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 500.09, 500.12, 570.07(23), FS.

LAW IMPLEMENTED: 381.986(10), 500.03, 500.04, 500.09, 500.10, 500.12, 500.121, 500.147, 500.171, 500.172, 500.173, 500.174, 500.177, 500.80 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Matthew Colson by email at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

5K-11.001 Definitions.

For the purposes of this rule chapter, the definitions in Section 500.03, F.S., and the following shall apply:

(1) Department means the Florida Department of Agriculture and Consumer Services.

(2) Edibles is defined as in Section 381.986(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.

(3) Marijuana Oil means oil derived from Low-THC Cannabis as defined in Section 381.986(e), F.S., or Marijuana as defined in Section 381.986(f), F.S.

(4) Medical Marijuana Treatment Centers (MMTC) are licensed by the Florida Department of Health as provided in 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 500.03, FS. History–New __________.

 

5K-11.002 – Permits and Fees.

(1) Pursuant to Subsection 381.986(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) Prior to applying for a food permit pursuant to this rule chapter, an MMTC shall undergo a plan review with the Department 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 request a plan review, an MMTC shall submit a completed Medical Marijuana Treatment Center Plan Review Application, FDACS-14032 (Rev. 01/19), and any applicable fees as outlined in paragraph 5K-4.004(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;

(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) Remit in full the required permit fee as described in Subsection (6);

(d) Provide to the Department a list of all Edibles the MMTC intends to produce or manufacture. This list shall be attached to the Medical Marijuana Treatment Center Food Permit Application, FDACS -14031 (Rev. 01/19); and 

(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 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 plan review in Paragraph (a) and initial inspection in Paragraph (e).

(5) Prior to implementation, MMTCs shall notify the Department in writing at [e-mail], 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) Food Permit Fees. 

(a) Applications for an initial food permit received by the Department between January 1 through June 30 shall be assessed a permit fee of $650.00, plus an epidemiology fee as prescribed in Section 381.006(10), F.S.

(b) Applications for an initial food permit received by the Department between July 1 through December 31 shall be assessed a permit fee of $325.00, plus an epidemiology fee as prescribed in Section 381.006(10), F.S.

(c)  The renewal permit fee shall be $650.00, plus an epidemiology fee as prescribed in Section 381.006(10), F.S.

(d) Late Fees. A late fee of $100.00 will be applied to all permit renewal applications not received by the Department as prescribed in Section 500.12, F.S. The Department shall not issue a food permit until all applicable fees, including late fees, are received by the Department.

(7) An MMTC may produce or manufacture Edibles in more than one physical location.  An MMTC must complete the application requirements and receive an individual food permit for each physical location, by address, in which Edibles are produced or manufactured.

(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 change in ownership.  Food permits are not transferable from one person or physical location to another. 

(9) The permit or permit number shall not be used on any label or in any advertisement of Edibles. Permits shall be conspicuously displayed at the locations for which they were issued.

Rulemaking Authority 500.09, 500.12, 570.07(23) FS. Law Implemented 381.006(10), 500.12, 500.147, FS. History–New _________.

 

5K-11.003 Inspections and Reinspections.

(1) Inspections.  The Department shall inspect the areas where Edibles are produced or manufactured at an MMTC to ensure compliance with the requirements of Chapter 500, F.S., and this rule chapter.

(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., 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) Edibles may not be manufactured, distributed, or sold under the Cottage Food Operations Law in Section 500.80, F.S.

(3) Food used to create Edibles shall be as defined in Paragraph 500.03(1)(n), F.S.

(4) Marijuana Oil shall not be considered an unapproved food additive as defined in Paragraph 500.03(1)(o), F.S., if used in the production and manufacture of Edibles by a licensed MMTC pursuant to Section 381.986, F.S., and in accordance with this rule chapter.

(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) This rule sets forth the guidelines the Department will follow in imposing the penalties authorized under Chapter 500, F.S., relative to the production and manufacture of Edibles. The purpose of the guidelines is to give notice of the range of penalties that will be imposed for a single violation within a three-year period. The three-year period shall be based on the date of the last administrative enforcement action imposed against the violator. These guidelines list aggravating and mitigating factors that, if present, will reduce or increase penalties to be imposed. No aggravating factors will be applied to increase a fine imposed for a single violation above the statutory maximum for a Class II category of $5,000 for each violation as provided in Section 570.971, F.S., except for violations of Section 500.165, F.S., which have a statutory maximum for a Class III category of $10,000 as provided in Section 570.971, F.S. The guidelines in this rule chapter are based upon a single count violation of each provision listed. Multiple counts of the violated provision or a combination of the listed violations will be added together to determine an overall total penalty and will be grounds for enhancement of penalties.

(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.

(3) Stop-Sale, Stop-Use, Release, or Destruction Orders. The Department shall issue a Stop-Sale,  Stop-Use, Release, and/or Destruction Order FDACS-14215, (Rev. 03/18), as provided in 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, Stop-Use, Release, and/or Destruction Order 14215, (Rev. 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, Stop -Use, Release, and/or Destruction Order is incorporated by reference in Rule 5K-4.035, F.A.C.

(4) Nothing in this rule shall limit the ability of the Department to informally dispose of administrative actions by settlement agreement, consent order, or other lawful means.

(5) Rule Not All-Inclusive. This rule contains illustrative violations. It does not, and is not intended to, encompass all possible violations of statute or Department rule that might be committed by any person. The absence of any violation from this rule shall in no way be construed to indicate that the violation does not cause harm to the public or is not subject to a penalty. In any instance where the violation is not listed in this rule, the penalty will be determined by consideration of:

(a)The closest analogous violation, if any, that is listed in this rule; and

(b)The mitigating or aggravating factors listed in this rule.

(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. The violation caused, or has the potential to cause, harm to the public and the degree or extent of such harm.

2. The violation endangered the public safety or welfare.

3. Previous violations for the same or a similar offense that resulted in enforcement action, defined as follows:

a. First Offense. A violation of any law subject to penalty under Chapters 500, F.S., when no disciplinary administrative complaints involving the same permitholder have been filed with the Agency Clerk within the three years preceding the date the current administrative complaint is issued.

b. Second Offense. A violation of any law subject to penalty under Chapters 500, F.S., after one disciplinary administrative complaint involving the same permitholder has been filed with the Agency Clerk within the three years preceeding the date the current administrative complaint is issued, even if the current violation is not the same as the previous violation.

c. Third and Any Subsequent Offense. A violation of any law subject to penalty under Chapters 500, F.S., after two disciplinary administrative complaint involving the same permitholder has been filed with the Agency Clerk within the three years preceeding the date the current administrative complaint is issued, even if the current violation is not the same as the previous violation.

4. The length of time the business has been in operation and the violation history over the past three years.

5. The violation was repeated within one year.

6. The violator impeded, or otherwise failed to cooperate with, the Department’s inspection and/or investigation.

7. Whether the violation resulted from negligence or an intentional act.

8. The cost of enforcement action.

9. The number of other violations proven in the same proceeding.

10. The benefit to the violator.

(b) Mitigating Factors:

1. Any documented efforts by the violator at rehabilitation.

2. Whether intentional actions of another party prevented the violator from complying with the applicable laws or rules.

3. Acts of God or nature that impaired the ability of the violator to comply with Chapters 500, F.S., or this rule chapter.

4. The violation has a low risk of, or did not result in, harm to the public health, safety, or welfare.

5. The disciplinary history of the violator.

6. The violator expeditiously took affirmative or corrective action after it received written notification of the violation to rectify any financial damage or harm to the public.

7. If a repeat violation, whether three years has passed since the prior violation.

(7) The provisions of this rule chapter shall not be construed so as to prohibit or limit any other civil action or criminal prosecution that may be brought.

(8) In addition to the penalties established in this rule, the Department reserves the right to seek to recover any other costs, penalties, attorney’s fees, court costs, service fees, collection costs, and damages allowed by law. Additionally, the Department reserves the right to seek to recover any costs, penalties, attorney’s fees, court costs, service fees, collection costs, and costs resulting from a payment that is returned for insufficient funds to the Department.

(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. Violations to paragraphs 5K-4.002(1)(c) - (e), F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

2. Violations to Subsection 5K-4.002(2), F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

3. Violations to Rule 5K-4.004, F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

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(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, stop-use order, and/or destruction order.  For the purposes of this rule, the following violations shall be considered Tier I violations:

a. Operating a food establishment with no hot water available.

b. Operating a food establishment while hot water is available, but the source is turned off.

c. Failure to provide copies of required microbiological and/or chemical analysis for review.

d. Operating a food establishment without the required service sink or curbed cleaning facility.

e. Failure to have an adequate or accurately maintained process control system including Hazards Analysis and Critical Control Points (HACCP), scheduled process, food safety plan, or any such other required by Rule 5K-4.002, F.A.C.

f. Failure to follow process control system such as Hazards Analysis and Critical Control Points (HACCP), scheduled process, food safety plan, or any such other required by Rule 5K-4.002, F.A.C.

g. The manufacture, sale or delivery, holding or offering for sale any Edible that is deemed adulterated as outlined in Section 500.10, F.S.

h. The manufacture, sale or delivery, holding or offering for sale any Edible that is misbranded as provided in Section 500.11, F.S, or in 21 CFR Part 101 as incorporated in Rule 5K-4.002.

i. Transporting food under conditions which may render the Edible to be deemed adulterated, as provided in Section 500.10, F.S.

j. The presence of a pathogenic Escherichia coli, Salmonella enterica, or Listeria monocytogenes found in the environment of a Food Establishment in a location where contamination of food is likely to occur from the presence of the organism(s). In case of such violation, a stop-use order(s) shall be issued and shall not be released by the Department until the Food Establishment has  cleaned and/or repaired the affected areas and  all  test results following  environmental sampling  are observed by the Department and reported as “negative”  from an ISO (International Organizaiton of Standardization) 17025 based accrediated laboratory certified to conduct testing for the microorganism of concern.  Any and all cleaning, repairs, environmental sampling and testing shall be at the expense of the facility.

k. Violation of 21 CFR Part 117.20, as incorporated in Rule 5K - 4.002, F.A.C., where sewage is not conveyed to the point of disposal through an approved sanitary sewage system or another system constructed, maintained, and operated according to law, which may result in a way that a public health hazard or nuisance is created.

l. Violation of 21 CFR Part 117.20, as incorporated in Rule 5K-4.002, F.A.C., premises are not maintained free of roaches and rodents.

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 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. Violations that result in a second and any subsequent notice of non-compliance or Tier 1 major violation for the same or similar offense, within a three-year period.

b. The receipt of two or more consecutive inspection reports not meeting requirements.

c. The receipt of an inspection report not meeting inspection requirements, followed by an inspection report meeting inspection requirements, followed by an inspection report not meeting inspection requirements, within a three-year period.

d. Refusal to permit entry or inspection during operating hours as required by Section 500.147, F.S.

e. Operating as a food establishment without a valid food permit, as provided in Section 500.12, F.S.

f. Any violation requiring an Immediate Final Order, as authorized by Chapter 500, F.S.

(10) Willful violations shall result in the imposition of an administrative fine of $5,000 per violation, permit suspension, or permit revocation or any combination thereof. The following shall constitute a willful violation:

(a) The unauthorized breaking, cutting, or removal of any seal or tag applied by the department.

(b) The sale or distribution, or offering for sale or distribution, of any commodity under stop sale order unless done so within the parameters of a conditional release.

(c) The use of any equipment under stop use order unless done so within the parameters of a conditional release.

(d) Failure to comply with conditions stipulated in a release of a stop sale, and/or stop use order.

(e) The intentional introduction of adulterated or misbranded products into commerce.

(f) The failure to comply with either a Final Order, Immediate Final Order, or a Default Final Order of the Department.

(g) Operating a food establishment that has been deemed an imminent threat to the public health, safety, and welfare by the Department for failure to comply with Chapter 500, F.S., and this rule chapter.

(h) The falsification of any records required under Chapter 500, F.S., and this rule chapter.

(11) Resolution Of Violations, Settlement, And Additional Enforcement Remedies.

(a) The Department and person(s) charged with a violation may agree to resolve violations prior to an administrative hearing or enter into settlement pursuant to Section 120.57(4), F.S. The penalties addressed in this rule chapter shall not be construed to limit the authority of the Department to resolve violations prior to or after initiation of any administrative action or to settle with any party. The Department shall utilize all available remedies to ensure compliance including administrative action, civil actions, settlements, and referrals for criminal prosecution. The Department shall enforce a failure to comply with an agreement to resolve violations or a settlement agreement with the penalties and remedies provided in the agreement and as authorized by Chapter 120 or Chapter 500, F.S.

(b) Failure to respond to an administrative complaint shall result in the entry of a Default Final Order against the violator or entity responsible for the violation. The Department shall impose administrative fines in a Default Final Order equal to the maximum amount possible, not to exceed $5,000 per violation.

(c) A violator’s failure to comply with either a Final Order or a Default Final Order of the Department shall result in additional enforcement actions as authorized by law.

(d) Fines resulting from multiple violations or Final Orders shall be assessed cumulatively.

Rulemaking Authority 500.09, 500.12, 570.07(23), FS. Law Implemented 500.04, 500.09, 500.121, 500.171, 500.172,  500.173, 500.174, 500.177, History–New,_____________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Matthew Colson, Chief of Food Inspection

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Nicole “Nikki” Fried, Commissioner of Agriculture

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 28, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: March 23, 2018