Pa. Medical Marijuana draft regulations for growers and processors. Part 3

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 § 1151.36.       Transportation of medical marijuana.

(a)        A grower/processor with a valid permit issued by the Departmentmay transport medical marijuana to a dispensary or a Department-approved laboratory in this Commonwealth.The following apply:

(1)        In order to transport medical marijuana to a dispensary within this Commonwealth, a grower/processor shall comply with the terms of this section.

(2)        A grower/processor may deliver medical marijuana to a dispensary or Department-approved laboratory only between the hours of 7 a.m. and 9 p.m.

(3)        A grower/processor may contract for delivery of medical marijuana so long as the contractor meets the qualifications in this section.

(4)        A grower/processorshall not transport medical marijuana to any place outside of this Commonwealth.

(5)        The grower/processor shall use a global tracking system to ensure safe, efficient delivery of the medical marijuana.

(b)        Vehicles allowed to transport medical marijuana shall:

(1)        Be equipped with a secure lockbox or locking cargo area, which shall be used for the sanitary and secure transport of medical marijuana.

(2)        Have no markings that would either identify or indicate that the vehicle is being used to transport medicinal marijuana.

(3)        Be capable of being temperature-controlled for perishable medical marijuana.

(4)        Have passed and display current state inspection and registration stickers.

(5)        Be insured in the amount of $1,000,000 per incident.

(c)        Each transport vehicle shall be staffed with a delivery team consisting of at least two employees and shall require the following:

(1)        At least one delivery team member shall remain with the vehicle at all times that the vehicle contains medical marijuana.

(2)        Each delivery team member shall have access to a secure form of communication with the grower/processor, such as a cellular telephone, at all times that the vehicle contains medical marijuana.

(3)        Each delivery team member shall carry an employee identification badge at all times and shall, upon demand, produce it to the Departmentor its authorized representatives, law enforcement or other state or federal government officials.

(4)        Each delivery team member shall have a valid Pennsylvania Driver’s License.

(5)        While on duty, a delivery team member may not wear any clothing or symbols that may indicate ownership or possession of medical marijuana.

(d)       Medical marijuana stored inside the transport vehicle shall not be visible from the outside of the transport vehicle.

(e)        A transport vehicle shall proceed from the grower/processor, where the medical marijuana is loaded, directly to the dispensary or Department-approved laboratory, where the medical marijuana is unloaded without intervening stops or delays, except to other permitted dispensaries or Department-approved laboratories receiving medical marijuana.

(f)        A grower/processor shall report any vehicle accidents, diversions, losses, or other reportable events that occur during transport to the Departmentimmediately.A grower/processor shall notify the Department of its delivery schedule, including routes and delivery times, through a designated phone line established by the Department.

(g)        A grower/processor shall complete a transport manifest as required by § 1151.37 (relating to transport manifest).

(h)        For purposes of this part, a transport vehicle shall be considered an extension of the permitted grower/processor and shall be subject to inspection by the Department or its authorized representatives,Department law enforcement or other federal, state or local government officials.  Transport vehicles may be stopped and inspected at any permitted grower/processor or dispensary, or while enroute during transportation.

 

§1151.37.        Transport manifest.

(a)        A grower/processor shall generate a printed transport manifest that accompanies every transport of medical marijuana andthat contains the following information:

(1)        The name, address and permit number of the grower/processor and the name of and contact information for a representative of the grower/processor.

(2)        The name, address and permit number of the dispensary receiving the delivery and the name of and contact information for a representative of the dispensary.

(3)        The quantity, by weight or unit, of each medical marijuana batch/lotcontained in each transport, along with the lot number for every batch.

(4)        The date of departure and approximate time of departure.

(5)        The date of arrival and approximate time of arrival.

(6)        The transport vehicle’s make and model and license plate number. 

(7)        The name and signature of each member of the delivery team accompanying the transport.

(b)        A grower/processor representative may transport medical marijuana from an originating location to multiple dispensaries as long as each transport manifest correctly reflects specific inventory in transit and each recipient dispensary provides the grower/processor with a printed receipt for medical marijuana delivered.

(c)        All medical marijuana being transported must be packaged in shipping containers and labeled in accordance with § 1151.35 (relating to packaging and labelling of medical marijuana).

(d)       A grower/processor shall provide a copy of the transport manifest to each dispensary receiving the inventory described in the transport manifest.  In order to maintain confidentiality, a grower/processor may separate the transport manifest for each receiving dispensary.

(e)        A grower/processor must, if requested, provide a copy of the printed transport manifest, and any printed receipts for medical marijuana being transported, to the Department, law enforcement or other federal, state or local government officials.

 

§ 1151.38.       Evidence of theft, diversion, or discrepancy during transport.

(a)        If a grower/processor finds evidence of a theft or diversion during transport, the grower/processor shall immediately report the theft or diversion to the Department and to the appropriate law enforcement authorities.

(b)        If a grower/processor finds a discrepancy in the transport manifest, the grower/processor shall:

(1)        Conduct an investigation.

(2)        Amend the grower/processor’s standard plan of operation, if necessary.

(3)        Send a report of the investigation to the Department.

(i)         A grower/processor shall submit a written preliminary report of the investigation within seven days of discovering the discrepancy.

(ii)        A grower/processor shall submit a final written report of the investigation within 30 days of discovering the discrepancy.

 

§ 1151.39.       Seed-to-sale tracking system.

A medical marijuana organization shall implement a seed-to-sale tracking system as required by the Departmentaddressing all of the requirements in § 701 of the Act.

 

§ 1151.40.       Disposal of marijuana and medical marijuana.

Solid and liquid wastes generated during the production, processing and testing of medical marijuana must be stored, managed, and disposed of in accordance with applicable state and local laws and regulations.

 

§ 1151.41.       Tax reporting.

(a)        The grower/processor must submit quarterly reports to the Department and the Department of Revenueas follows:

(1)        On a form or electronic system designated by the Department.

(2)        Returns are due on or before the twentieth day of the month following the close of the previous quarter, including periods with no activity or payment due.

(3)        Submit, with payment due, to the Department of Revenueon or before the twentieth day of the month, following the close of the previous quarter. When the twentieth day of the month falls on a Saturday, Sunday, or a legal holiday, the filing must be postmarked by the U.S. Postal Service no later than the next postal business day.

(b)        All records must be maintained and available for review for a four-year period.

(c)        A penalty oftwo percent per month will be assessed on any payments postmarked after the twentieth day of the month following the quarter of sale. When the twentieth day of the month falls on a Saturday, Sunday, or a legal holiday, the filing must be postmarked by the U.S. Postal Service no later than the next postal business day. Absent a postmark, the date received by the Departmentor its authorized designee shall be used to assess the penalty of 2% per month on payments received after the twentieth day of the month following the quarter of sale.

(d)       Failure to make a report or pay the sales taxes and penalties, or both, in the manner and dates outlined in this section will be sufficient grounds for the Departmentto suspend or revoke a grower/processor permit.

 

§ 1151.42.       Recall of marijuana or medical marijuana.

(a)        The following apply regarding voluntary recalls:

(1)        A grower/processor may withdraw medical marijuana from the market by its owndetermination for reasons that do not pose a risk to public health and safety, such as for aesthetic reasons or other similar deficiencies in product or packaging.

(2)        If a grower/processor issues a recall for a reason that does not pose a risk to public safety, the grower/processor shall notify the Departmentwithin 48 hours of beginning the market withdrawal. 

(b)        The following apply regarding mandatory recall:

(1)        If a condition that poses a risk to public safety exists, the grower/processor shall:

(i)         Immediately notify the Department.

(ii)        Secure, isolate and prevent the distribution of all medical marijuana that may have been affected by the condition warranting the recall.  The grower/processor may not destroy any affected medical marijuana prior to notifying the Departmentand coordinating that destruction with the Department.

(2)        If a grower/processor fails to cooperate with the Departmentin recall activities, or fails to immediately inform the Departmentof a need for a recall upon becoming aware of the public health and safety concern, the Departmentmay seek a cease and desist order under § 1141.49(relating to general penalties and sanctions)

(3)        Notwithstanding paragraph (2), a grower/processor that fails to cooperate with the Departmentin recall activities, or that fails to immediately inform the Departmentof a need for a recall upon becoming aware of the public safety concern may be subject to the penalties and sanctions provided for by the Act and this Part.

(c)        A grower/processor shall develop a recall plan as part of its policies and procedures that sets the procedures for the recall of medical marijuana.  A recall plan must include the following:

(1)        Designation of a member of the grower/processor’s staff who serves as the recall coordinator.

(2)        Procedures for identifying and isolating product to prevent or minimize its distribution to patients, caregivers and other medical marijuana organizations.

(3)        Procedures to retrieve and destroy product.

(4)        A communications plan to notify those affected by the recall, including:

(i)         How the grower/processor will notify other medical marijuana organizations in possession of marijuana or medical marijuana subject to the recall.

(ii)        The use of press releases and other appropriate notifications to ensure patients and caregivers are notified of the recall if the affected medical marijuana was distributed to patients and caregivers.

(5)        Procedures for notifying the Department.

(6)        Procedures for entering information relating to the recall into the grower/processor’s tracking system.

(d)       A recall must follow the procedures outlined in the grower/processor’s recall plan, unless changes are otherwise approved by the Department. The grower/processor must ensure recall procedures are conducted to maximize recall of affected medical marijuana and minimize risks to public health and safety.

(e)        A grower/processor shall coordinate destruction of affected medical marijuana with the Departmentand allow the Departmentor its representative, at its discretion, to oversee the destruction of affected medical marijuana recalled to ensure the destruction of affected medical marijuana that poses risks to public health and safety.  Disposal shall otherwise comply with the requirements of § 1151.40(relating to disposal of marijuana and medical marijuana).

(f)        The grower/processor shall enter information relevant to the recall into the electronic tracking system as part of the daily inventory, including:

(1)        The total amount of affected medical marijuana, including types, forms and batches and lots, if applicable.  

(2)        The amount of affected medical marijuana returned to the grower/processor as part of the recall effort, including types, forms and batches and lots, if applicable, by day.  

(3)        The total amount of affected medical marijuana returned to the grower/processor as part of the recall effort, including types, forms and batches and lots, if applicable.

(4)        When the affected medical marijuana was received.

(5)        The name of the recall coordinator or other persons responsible for accepting the recalled medical marijuana.

(6)        From whom the affected medical marijuana was received, when and by what means of transport.

(7)        The reason for the recall.

(8)        Sample amounts, types, forms and batches and lots, if applicable, sent to testing laboratories, including the name and address of the laboratory, dates of testing, and results by sample.

(9)        The name of the person overseeing disposal, the name of the disposal company, if applicable, the method of disposal, the date of disposal and the amount disposed of by types, forms and batches and lots, if applicable.

(10)      Any other information required by the Department.

 

§ 1151.43.       Medical marijuana organization required training.

(a)        A principal of a medical marijuana organization shall complete a Department-approved two-hour training course prior to commencing initial operation of the medical marijuana organization.  

(b)        An employee who has direct contact with patients or caregivers or who physically handles medical marijuana shall complete a Department- approved two-hour training course within 90 days after beginning work at a medical marijuana organization.

(c)        The two-hour training course shall provide information to principals and employees on:

(1)        Federal and state medical marijuana laws and regulations and other laws and regulations pertinent to the responsibilities of principals and employees.

(2)        Standard operating procedures within the medical marijuana organization.

(3)        Proper handling of medical marijuana.

(4)        Proper recordkeeping.

(5)        Detection and prevention of diversion of medical marijuana.

(6)        Security procedures.

(7)        Safety procedures, including responding to the following:

(i)         A medical emergency.

(ii)        A fire.

(iii)       A chemical spill.

(iv)       A threatening event including:

(A)       An armed robbery.

(B)       A burglary.

(C)       A criminal incident.

(d)       The medical marijuana organization shall obtain and retain the training materials and attendance records of its principals and employees and shall make the training materials available for inspection by the Departmentupon request.

(e)        The Departmentmay require additional education or training for principals, operators and employees of a medical marijuana organizationthat has a valid permit issued by the Departmentat any time, with adequate notice to the medical marijuana organization.

(f)        The Departmentwill make the two-hour training course available at no cost.\

 

§ 1151.44. Pesticides

(a)      The use of any pesticide by a grower/processor in the growth or manufacture of medical marijuana shall be in accordance with theact of March 1, 1974 (P.L. 90, No. 24), known as thePennsylvania Pesticide Control Act of 1973 (3 P.S. §§ 111.21-111.61) and this Part.

 (b)       The Department, in cooperation with the Department of Agriculture, will inspect for and enforce the following requirements on growers/processors.

(c)        The following apply regarding recordkeeping requirements for pesticide applications:

(1) The grower/processor shall keep for each application of a pesticide a record containing the following information:

(i) The date of application. For a pesticide requiring a re-entry time, the date of application must include the hour completed.

(ii) The place of application including the name and address of the grower/processor and the specific block, section, or plants treated.

(iii) The size of the area treated.

(iv) The brand name of every pesticide used.

(v) The EPA product registration number. This requirement is unnecessary for products exempted under section 25(b) of the Federal Insecticide, Fungicide and Rodenticide Act of 1947.

(vi) The total amount of every pesticide used in pounds, ounces, gallons, or liters, applied to a treated area.

(vii) The dosage or rate of application of every pesticide used.

(viii) The names of all persons involved in making the pesticide, and when applicable,the permit or certification numbers of the persons making or supervising the application.

(ix)  The grower/processor shall maintain a file containing copies of pesticide labels and Safety Data Sheets for all pesticides used at the site.

(2) A record required to be kept under this section shall be completed within 24 hours of the completion of the application and maintained for at least 4 years and shall be made immediately available to medical personnel in the case of an emergency, the Department or its authorized representatives and the Department of Agriculture upon request.

(d)       The Department and the Department of Agriculture may cooperate and enter into agreements in order to secure uniformity of regulations and enforcement with regard to pesticides and to develop and administer training and educational programs.

(e)        For purposes of enforcement, all provisions of the act of March 1, 1974 (P.L. 90, No. 24)(3 P.S. §§ 111.21—111.61) known as the Pennsylvania Pesticide Control Act of 1973 and the attendant regulations at 7 Pa.Code §§ 128.1 et seq. are hereby incorporated by reference and adopted as standards of the Department for the production of medical marijuana. 

(f)        Acceptable pesticide active ingredients for use in growing and processingmedical marijuana are listed in Appendix A.

(g)The following words and phrases, when used in this section, have the following meanings, unless the context clearly indicates otherwise:

Defoliant.— Any substance or mixture of substances intended for causing the leaves or foliage to drop from a plant, with or without causing abscission.

Desiccant.— Any substance or mixture of substances intended for artificially accelerating the drying of plant tissue.

General use pesticide.— A pesticide which is not classified as a restricted use pursuant to section 3(d) of the Federal Insecticide, Fungicide and Rodenticide Act of 1947, as amended in 1972, or a pesticide that the Secretary of Agriculture has determined to be restricted pursuant to the Pesticide Control Act of 1973, Act of March 1, 1974( P.L. 90, No. 24) (3 P.S. 111.21 – 111.61) (1987) Section 6 (b)(6). The term includes pesticides exempted that are permitted to be distributed under a Federal exemption under section 18 or 25(b) of Federal Insecticide, Fungicide and Rodenticide Act of 1947 (7 U.S.C.A. §§ 136p and 136w(b)) and are registered by the State.

Pesticide.— Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, and any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant.

Plant regulator. — Any substance or mixture of substances intended, through physiological action, for accelerating or retarding the rate of growth or rate of maturation, or for otherwise altering the behavior of plants or the produce thereof, but shall not include substances to the extent that they are intended as plant nutrients, trace elements, nutritional chemicals, plant inoculants, and soil amendments.  The term does not include any of those nutrient mixtures or soil amendments as are commonly known as vitamin-hormone horticultural products, which are intended for improvement, maintenance, survival, health, and propagation of plants, and as are not for pest destruction and are nontoxic, nonpoisonous in the undiluted packaged concentration.

Restricted use pesticide. — The use of a pesticide which is classified as a restricted use pursuant to section 3(d) of the Federal Insecticide, Fungicide and Rodenticide Act of 1947, as amended in 1972, or a pesticide that the Secretary of Agriculture has determined to be restricted pursuant to the Pesticide Control Act of 1973, Act of March 1, 1974, (P.L. 90, No. 24) (3 P.S. 111.21 – 111.61) (1987) Section 6 (b)(6).

 

§1151.45.        Treatment and quarantine orders.

(a)     Where a plant pest is found, the Department, in cooperation with the Department of Agriculture under the authority of the Plant Pest Act, may issue and enforce a treatment order, including an order to eradicate, for any plant that may carry or harbor the plant pest. Such order will be issued in writing and set forth the necessary treatment, control or eradication measures required. If a grower/processor who has been issued a treatment order fails or refuses to comply with such order, the Department, acting in cooperation with the Department of Agriculture, may carry out the control measures established in the treatment order with all expenses associated with such measures accruing to the grower/processor failing or refusing to comply.

(b)     The Department of Agriculture, acting with cooperation of the Department, may establish a Quarantine to prevent the dissemination of plant pests within the Commonwealth or to prevent or delay the introduction of a plant pest into the Commonwealth from any country, state or territory. The following apply:

(1)        Upon finding a plant pest in a grower/processor operation that has the potential to cause serious damage to other grower/processors or agriculture, the geographic area in which the plant pest was found and any adjacent areas as the Department of Agriculture may deem necessary shall be quarantined.

(2)        The Quarantine Order shall establish conditions and restrictions considered necessary to prevent or reduce the movement of the plant pest from the quarantine area. Vehicles or any means of conveyance suspected of carrying the plant pest may be subject to quarantine and a treatment order may be issued to as necessary to eradicate the plant pest. 

(3)        The Quarantine Order may regulate the planting, growing or harvesting of any crop that serves as a host or reservoir for the plant pest within the quarantined area and may include prohibiting the establishment of a specific batch of medical marijuana within a specific geographic area or during a specified time period. A crop suspected of harboring the plant pest may be ordered to be treated or destroyed.

 

§ 1151.46.       Insurance requirements.

Each grower/processor shall have appropriate insurance coverage of the buildings and equipment and adequate comprehensive liability insurance, or an equivalent self-insurance plan, covering principals, officers and employees.

 

 

 

 

 

 

 

 

APPENDIX A—Acceptable pesticide active ingredients for use:

 

The following pesticides can be can be used legally in the production of medical marijuana and in accordance with the Pesticide Control Act.  Products containing the active ingredients listed here must also be labeled for use in greenhouses on food crops to qualify. 

EPA Status

Pesticide Type

Comments

Active Ingredient

25(b)

Insecticide

 

Castor Oil

25(b)

Insecticide

 

Cedar Oil

25(b)

Insecticide

 

Cinnamon

25(b)

Fungicide, Insecticide

 

Cinnamon Oil

25(b)

Fungicide, Insecticide

 

Citric Acid

25(b)

Bactericide, Fungicide

 

Clove

25(b)

Insecticide

 

Clove Oil

25(b)

Fungicide

 

Corn Oil

25(b)

Insecticide

 

Cottonseed Oil

25(b)

Insecticide

 

Garlic

25(b)

Insect Repellent

 

Garlic Oil

25(b)

Fungicide

 

Geraniol

25(b)

Insecticide

 

Geranium Oil

25(b)

Fungicide, Insecticide

 

Lemon Grass Oil

25(b)

Insecticide

 

Peppermint Oil

25(b)

Insecticide

 

Peroxyacetic Acid

25(b)

Fungicide

 

Potassium Sorbate

25(b)

Insecticide

 

Rosemary

25(b)

Insecticide

 

Rosemary Oil

25(b)

Fungicide, Insecticide, Miticide

 

Sesame Oil

25(b)

Fungicide, Insecticide

 

Sodium Lauryl Sulfate

25(b)

Insecticide

 

Soybean Oil

25(b)

Fungicide

 

Thyme

25(b)

Fungicide, Insecticide, Miticide

 

Thyme oil

25(b)

Insecticide

 

White Pepper

Sec 3 Products

Insecticide

 

Azadirachtin

Sec 3 Products

Fungicide

 

Bacillus Amyloliquefaciens Strain D747

Sec 3 Products

Fungicide

For use in protected growing environments only (e.g., greenhouses).

Bacillus Pumilus Strain GHA 180

Sec 3 Products

Fungicide

 

Bacillus Subtilis QST713 Strain

Sec 3 Products

Insecticide

 

Bacillus Thuringiensis SSP. Aizawai

Sec 3 Products

Insecticide

 

Canola Oil

Sec 3 Products

Insect Repellent

 

Capsicum Oleoresin Extract

Sec 3 Products

Insecticide

Ground application only to non-blooming plants.

Chromobacterium Sub Strain PRAA4-1 Cells

Sec 3 Products

Fungicide, Insecticide

 

Clarified Hydrophobic Extract of Neem Oil

Sec 3 Products

Fungicide

 

Copper Octanoate

Sec 3 Products

PGR

 

Cytokinin (Kinetin)

Sec 3 Products

Insecticide

 

Diatomaceous Earth

Sec 3 Products

PGR

 

Gibberellins (Gibberellic Acid)

Sec 3 Products

PGR

 

Harpin Alpha Beta

Sec 3 Products

Antimicrobial, Fungicide

No foliar applications allowed.

Hydrogen Peroxide

Sec 3 Products

PGR

Applications allowed in furrow at planting or in hydroponics only.

IBA (Indole-3-Butyric Acid)

Sec 3 Products

Insecticide, PGR

 

Kaolin

Sec 3 Products

Insecticide

 

Mineral Oil

Sec 3 Products

Fungicide

Use only allowed prior to final transplant, unless grown in recirculating hydroponics systems.

Mono- and Di-Potassium Salts of Phosphorous Acid

Sec 3 Products

Insecticide

 

Monopotassium Phosphate

Sec 3 Products

Nematicide

 

Myrothecium Verrucaria

Sec 3 Products

Fungicide, Insecticide

 

Neem Oil, Cold Pressed

Sec 3 Products

Insecticide

Use allowed prior to final transplant.

Piperonyl Butoxide

Sec 3 Products

Insecticide

Use allowed prior to final transplant.

Potassium Laurate

Sec 3 Products

Fungicide, Insecticide

 

Potassium Salts of Fatty Acids

Sec 3 Products

Insecticide

 

Pyrethrins

Sec 3 Products

Insecticide

 

Pyrethrins

Sec 3 Products

Molluscicide

 

Sodium Ferric EDTA

Sec 3 Products

Fungicide

 

Trichoderma Asperellum Strain ICC 012

 

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