PROPOSED RULEMAKING

DEPARTMENT OF HEALTH

[ 28 PA. CODE CHS. 1131—1230 AND 1141a—1230a ]

Medical Marijuana

[51 Pa.B. 1141]
[Saturday, March 6, 2021]

 The Department of Health (Department) proposes to promulgate permanent regulations in 28 Pa. Code Part IXa (relating to medical marijuana) by replacing the current temporary regulations at 28 Pa. Code Part IX. The proposed permanent regulations are set forth in Annex A.

A. Purpose of the Proposed Rulemaking

 Under the authority of section 1107 of the Medical Marijuana Act (35 P.S. § 10231.1107) regarding temporary regulations, the Department promulgated temporary regulations to facilitate the prompt implementation of the Medical Marijuana Act (act) (35 P.S. §§ 10231.101—10231.2110) published at 46 Pa.B. 3254 (June 25, 2016); 46 Pa.B. 6829 (October 29, 2016); 46 Pa.B. 8036 (December 24, 2016); 47 Pa.B. 73 (January 7, 2017); 47 Pa.B. 74 (January 7, 2017); 47 Pa.B. 199 (January 14, 2017); 47 Pa.B. 217 (January 14, 2017); 47 Pa.B. 269 (January 14, 2017); 47 Pa.B. 3096 (June 3, 2017); 47 Pa.B. 6938 (November 11, 2017); and 48 Pa.B. 1508 (March 17, 2018). Under section 1107 of the act, the Department's authority to adopt temporary regulations was to expire May 12, 2018, 2 years after the effective date of section 1107 of the act. Prior to the expiration of its authority to adopt temporary regulations, the Department promulgated a second set of temporary regulations, with an expiration date of May 12, 2020, published at 48 Pa.B. 2767 (May 12, 2018); 48 Pa.B. 2793 (May 12, 2018); 48 Pa.B. 2801 (May 12, 2018); 48 Pa.B. 2806 (May 12, 2018); 48 Pa.B. 2810 (May 12, 2018); 48 Pa.B. 2814 (May 12, 2018); and 48 Pa.B. 2767 (May 12, 2018). Act 10 of 2020, section 1736-A.1, extended the expiration date of the temporary regulations to November 20, 2021.

 On June 22, 2018, the General Assembly amended Chapter 20 of the act (35 P.S. §§ 10231.2000—10231.2004) and provided the Department with authority to issue new temporary regulations to implement the revised Chapter 20. Under section 2004 of the act (35 P.S. § 10231.2004), the Department's authority to issue Chapter 20 temporary regulations was to expire 2 years after initial publication of the amended Chapter 20 temporary regulations. The Department rescinded the initial Chapter 20 temporary regulations on July 28, 2018, at 48 Pa.B. 4493 (July 28, 2018), and promulgated revised Chapter 20 temporary regulations at 48 Pa.B. 5072 (August 18, 2018) and 48 Pa.B. 7778 (December 22, 2018).

 This proposed rulemaking is intended to revise and replace the current temporary regulations found in Part IX to implement permanent regulations governing the medical marijuana program in proposed Part IXa. These proposed regulations will further the purpose of the act by providing access to medical marijuana for patients with serious medical conditions; ensuring a safe and effective method of distribution; and promoting high-quality research into the efficacy of medical marijuana.

 As a prefatory note, the current temporary regulations include Chapter 1131 (relating to safe harbor letter—temporary regulations). Chapter 1131 has expired and will be reserved.

B. Requirements of the Regulation

Chapter 1141a. General Provisions

 This proposed chapter replaces the current Chapter 1141 (relating to general provisions—temporary regulations). Proposed new sections and amendments to sections of the current temporary regulations are discussed more fully as follows.

§ 1141a.21. Definitions

 This proposed section replaces the current § 1141.21 (relating to definitions). In addition to including all definitions currently in § 1141.21, this proposed section consolidates all definitions under this proposed part in this section instead of defining the terms separately in each chapter.

 Beyond consolidating terms that are defined elsewhere, this section proposes to revise the definitions of the following terms defined in the current temporary regulations. The definition of ''ACRC'' is proposed to mirror the definition of ''Academic Clinical Research Center'' in the act and the definition of ''certified ACRC'' is proposed to be deleted as redundant. The definition of ''added substance'' is proposed to be revised by replacing ''and'' with ''or'' to clarify that either an ''additional ingredient'' or ''any substance'' constitutes an ''added substance.'' Additionally, ''any substances'' is proposed to be revised to the singular ''any substance.'' The definition of ''applicant'' is proposed to be revised to include persons who apply to become an approved laboratory, an ACRC, or a clinical registrant and to move subsections (ii) and (iii) from subsection (C) to subsection (B), as initial placement in subsection (C) was an error.

 The definition of ''CBD'' is proposed to be revised to add the substance's Chemical Abstracts Service (CAS) number to conform to scientific standards of substance identification. The definition of ''clinical registrant'' is proposed to be revised to add proposed subsection (iii) because the unnecessary definition of ''approved clinical registrant'' was deleted. The definition of ''continuing care'' is proposed to be revised to mirror the definition in the act by adding ''including an in-person consultation with the patient'' to the end. The definition of ''controlling interest'' is proposed to mirror the definition in the act by changing ''company'' to ''entity'' in subsection (i).

 The definition of ''laboratory applicant'' is proposed to be deleted as the definition of ''applicant'' is revised to include persons who apply to become an approved laboratory. The definition of ''marijuana'' is proposed to be revised to exclude synthetic marijuana. The definition of ''medical marijuana organization'' is proposed to be revised to remove the exclusion of a clinical registrant, to comport with section 2002(b)(5) of the act (35 P.S. § 2002(b)(5)). The definition of ''municipality'' is proposed to be revised to add ''county'' and ''or any similar general purpose unit of government which shall hereafter be created by the General Assembly.'' The definition of ''permit'' is proposed to be revised by changing ''applicant'' to ''medical marijuana organization'' to reflect the definition of ''permit'' in the act.

 The definition of ''serious medical condition'' is proposed to be revised to add ''anxiety disorders,'' ''Tourette's Syndrome'' and any other condition recommended by the Medical Marijuana Advisory Board (Board) and approved by the Secretary. These revisions follow from section 1202 of the act (35 P.S. § 10231.1202), which charged the Board with issuing a final report making various recommendations in section 1201(j) of the act (35 P.S. § 10231.1201(j)). The Board issued its final report and, in accordance with section 1201(j)(6) of the act, adopted the report at a public meeting on April 9, 2018. The Board's final report recommended that a process be established for a subcommittee of the Board to review and approve additional serious medical conditions on a continuous basis; the Secretary approved this recommendation at 48 Pa.B. 2898 (May 12, 2018). The definition of ''THC'' is proposed to be revised to clarify that the term refers to ''Delta-9'' tetrahydrocannabinol.

 Further, this proposed section defines these previously undefined terms: ''added substance,'' ''CAS number,'' ''CBC,'' ''CBDA,'' ''CBDV,'' ''CBG,'' ''CBN,'' ''cannabinoids,'' ''D8,'' ''medical marijuana extract,'' ''professional disciplinary action,'' ''THCA,'' ''THCV'' and ''terpenes.'' The addition of these terms and corresponding definitions is meant to provide greater clarity in identifying the chemical compounds used in medical marijuana products.

 Finally, due to revising the definition of ''applicant,'' the Department proposes to delete the definitions of ''approved clinical registrant'' and ''certified ACRC'' as unnecessary. To correspond to these changes, the Department proposes to revise the definitions of ''IRB,'' ''RAC'' and ''Research contract'' to delete the reference to ''certified'' ACRC.

§ 1141a.22. Records subject to disclosure; confidentiality

 This proposed section replaces the current § 1141.22 (relating to records subject to disclosure; confidentiality). The Department proposes to revise subsection (b) and to add subsections (f) and (g), as detailed as follows.

Subsection (a).

 This proposed subsection mirrors the current subsection (a). This proposed subsection lists what records are public records subject to disclosure under the Right-to-Know Law (RTKL) (65 P.S. §§ 67.101—67.3104).

Subsection (b).

 This proposed subsection lists what information is considered confidential and not subject to the RTKL. The Department proposes to revise paragraph (11) of this subsection to replace the phrase ''The names and any other information relating to'' with ''Any information that would identify.'' This amendment is being proposed to clarify any ambiguity relating to the confidentiality of individuals who review permit applications to protect the identities of, and any other information pertaining to, those individuals.

 Section 306 of the RTKL (65 P.S. § 67.306) provides that ''[n]othing in [the RTKL] shall supersede or modify the public or nonpublic nature of a record or document established in. . .regulation.'' To score the permit applications, the Department collaborated with a multitude of Commonwealth agencies. In an effort to dissuade applicants from attempting to exert any improper influence—an unfortunate but realistic concern when introducing a new billion-dollar industry—the Department protected the confidentiality of individuals who scored the applications by promulgating the temporary regulation, and the Department has determined that this protection remains necessary to carry out the provisions of the act.

Subsection (c).

 This proposed subsection mirrors the current subsection (c). This proposed subsection provides that applicants are responsible for marking confidential proprietary information contained in their applications prior to submission.

Subsection (d).

 This proposed subsection mirrors the current subsection (d). This proposed subsection provides that an applicant's failure to redact confidential proprietary information contained in the application will result in the disclosure of that information if requested under the RTKL.

Subsection (e).

 This proposed subsection mirrors the current subsection (e), except for adding language to clarify that an applicant is responsible for defending only those redactions it makes to protect its confidential proprietary or trade secret information. This proposed subsection provides that applicants are responsible for defending those redactions in their applications in any administrative or court hearing and that unsuccessful defense thereof may result in full disclosure of the application in unredacted form.

Subsection (f).

 This proposed subsection is new and provides that the Department may release de-identified data for research purposes that are subject to approval and oversight by the Department and an Institutional Review Board (IRB). The nascent nature of the medical marijuana program requires not only constant review of the efficacy of the program for its current purposes, but also research into potential areas of improvement. The addition of this proposed new subsection serves to effectuate those goals.

Subsection (g).

 This proposed subsection is new and permits the Department to collaborate with other Commonwealth agencies for purposes of investigating and enforcing violations of the act and regulations. This is necessary because other agencies have regulatory authority outside of the act, such as the Department of State in the licensing and professional conduct of practitioners, and collaboration is required by the act.

§ 1141a.23. Limitation on number of permits

 This proposed section mirrors the current § 1141.23 (relating to limitation on number of permits), except for changing ''Notwithstanding'' to ''Except as provided in'' as the introduction to the section and revising incorrect citations in paragraph (3). This proposed section sets the limits on the amount of grower/processor and dispensary permits the Department may issue and the limit of permits that may be received by one person.

§ 1141a.24. Medical marijuana regions

 This proposed section mirrors the current § 1141.24 (relating to medical marijuana regions). This proposed section outlines the geographic areas contained in each of the six medical marijuana regions in this Commonwealth. Further, this proposed section provides factors the Department will consider when issuing a permit and that the Department may change the number or boundaries of the regions every 2 years.

§ 1141a.25. General requirements for permits

 This proposed section mirrors the current § 1141.25 (relating to general requirements for permits). This proposed section outlines the general guidelines and prohibitions with respect to permits.

§ 1141a.26. Privilege and nontransferability

 This proposed section mirrors the current § 1141.26 (relating to privilege and nontransferability). This proposed section provides that the issuance or renewal of a permit is a revocable privilege, and that permits are nontransferable.

§ 1141a.27. General requirements for application

 This proposed section replaces the current § 1141.27 (relating to general requirements for application). The Department proposes to revise subsections (a), (c) and (d), as detailed as follows.

Subsection (a).

 This proposed subsection lists the types of applications to be submitted to the Department. The Department proposes to revise subsections (a)(3), (a)(4) and (a)(5) by deleting the phrase ''as authorized by a permit.'' This phrase is unnecessary because the definitions of ''medical marijuana organization'' and ''facility'' make clear that a permit has been issued. The Department proposes to additionally revise subsection (a)(4), which currently provides for ''[a]n application for approval of a change of location of a facility.'' This proposed rulemaking revises subsection (a)(4) to add that an application to change location may be submitted only for an ''operational'' facility. This revision clarifies that the regulation was never intended to apply to non-operational facilities, as permit applications are scored based upon the location provided within the application itself, and a successful applicant's attempt to relocate before operationalizing the location provided in the application undercuts the application and scoring processes. Beyond these revisions, this proposed subsection mirrors the current subsection (a).

Subsection (b).

 This proposed subsection mirrors the current subsection (b). This proposed subsection provides that, by submitting an application, an applicant consents to any necessary investigations to ensure the applicant's ability to meet the requirements under the act.

Subsection (c).

 This proposed section mirrors the current subsection (c), except for changing the citation in proposed subsection (c)(1) to refer to this proposed chapter and adding ''for an initial permit or for a permit renewal'' after ''application'' to clarify that this provision applies to medical marijuana permit applications. This proposed subsection lists the information that is required with the submission of an application. If this required information is not included, the application will be rejected as incomplete.

Subsection (d).

 This proposed subsection provides that an incomplete application will be rejected. This proposed subsection revises the language in the current subsection (d), which provides that ''[a]n application that is rejected by the Department as incomplete will be returned to the applicant without further consideration by the Department and the initial permit fee will be refunded.'' This proposed subsection removes the requirement on the Department to return an incomplete application, making for a more efficient and cost-effective operation. Additionally, the language regarding refunding the initial permit fee has been relocated to proposed § 1141a.28(a)(2) and (b)(2). This proposed section also adds ''for an initial permit'' after ''application'' to clarify that this provision applies only to initial permit applications.

§ 1141a.28. Fees

 This proposed section replaces the current § 1141.28 (relating to fees), with revisions to subsections (a), (b) and (c), as detailed as follows.

Subsection (a).

 This proposed subsection provides the fee amounts for initial and renewal grower/processor permits, and to whom initial permit fee refunds will be refunded. The current subsection (a) provides that the fee for these permits must be paid by ''certified check or money order.'' This proposed subsection expands the acceptable forms of payment to include cashier's checks. This revision provides applicants greater flexibility in their choice of payment. Proposed subsection (a)(2) is revised to clarify that the permit fee will be refunded if the application is rejected, as well as if the permit is not granted. Beyond these revisions, this proposed subsection mirrors the current subsection (a).

Subsection (b).

 This proposed subsection provides the fee amounts for initial and renewal dispensary permits, and to whom initial permit fees will be refunded. The current subsection (b) provides that the fee for these permits must be paid by ''certified check or money order.'' This proposed subsection will expand the acceptable forms of payment to include cashier's checks. This revision will provide applicants greater flexibility in their choice of payment. Proposed subsection (b)(1) is revised to match the language in subsection (a)(1) and proposed subsection (b)(2) is revised to clarify that the permit fee will be refunded if the application is rejected, as well as if the permit is not granted. Beyond these revisions, this proposed subsection mirrors the current subsection (b).

Subsection (c).

 This proposed subsection provides that a medical marijuana organization shall pay a $250 fee for: (1) ''an application for approval of a change in ownership;'' (2) an application for approval of a change of location of a facility; and (3) an application for approval of alteration of a facility. The proposed subsection makes three changes to the current subsection. First, the Department proposes to add ''cashier's check'' as an acceptable form of payment in subsection (c), consistent with the revisions to proposed subsections (a) and (b). Second, the Department proposes to delete the unnecessary phrase ''authorized by permit'' in current subsection (a)(2) and (3). Finally, the Department proposes to revise the current subsection (c)(2) to add the word ''operational'' before ''facility,'' consistent with the revision to § 1141a.27(a)(4) (relating to general requirements for application) to provide that a permittee must operationalize a facility at the location included in its application before it may attempt to move location.

§ 1141a.29. Initial permit application

 This proposed section replaces the current § 1141.29 (relating to initial permit application). While this proposed section largely tracks the current § 1141.29, this proposed section includes amendments to subsections (a) and (b), as detailed as follows.

Subsection (a).

 This proposed subsection mirrors the current subsection (a), except for changing the citation in proposed subsection (a)(2) to refer to this proposed chapter. This proposed subsection provides that the Department will publish notice of initial application availability in the Pennsylvania Bulletin; that the applicant may only use the application form prescribed by the Department; that applicants are required to redact their applications; and that untimely submissions will not be accepted.

Subsection (b).

 This proposed subsection requires certain information from an applicant in addition to that required by proposed § 1141a.27. Beyond the revisions detailed as follows, proposed subsection (b) mirrors the current regulatory provisions.

 This proposed subsection revises the citations in proposed subsections (b), (b)(6)(iii), (b)(9)(iv), (b)(12)(xii) and (b)(13) to refer to this proposed chapter.

 Further, this proposed subsection revises the language of the current subsection (b)(6)(iv) by adding ''financial backer'' to the introductory phrase for consistency throughout the subsection. Currently, subsection (b)(6)(iv)(B) requires an affidavit from each principal or operator of the applicant setting forth ''[w]hether the principal, operator or financial backer has been convicted of a criminal offense graded higher than a summary offense.'' This proposed subsection revises this language to reflect that applicants must disclose if they had previously been convicted of a criminal offense graded higher than a summary offense ''in this Commonwealth or the lowest-graded criminal offense in another State or country.'' This revision clarifies standards for reporting criminal convictions to the Department in light of the differing gradations of crimes in other states and countries. Proposed subsection (b)(6)(iv) also adds subsections (C) and (D), which are reworded and relocated from current subsection (b)(9)(vi) and (vii), because that subsection is more appropriately located in the section of the application requiring disclosures by means of affidavit.

 Last, this proposed subsection revises the language in current subsection (b)(9)(v). Currently, subsection (b)(9) outlines the types of evidence that would factor into the Department's determination of an applicant's ability to establish and operate a facility. Subsection (v) was deleted as duplicative of background check requirements in subsection (b)(6). Subparagraphs (vi) and (vii) are moved as reworded to § 1141a.29(b)(6)(iv) because they are more appropriately located in the section of the application requiring disclosures by means of affidavit.

 Current subsection (b)(9)(v) provides that the Department will factor in evidence of criminal actions graded higher than a summary offense under the laws of (1) Pennsylvania, (2) any other state, (3) the United States, or (4) a military, territorial or tribal authority. Consistent with amendments in proposed subsection (b)(6)(iv)(B), this proposed revision requires that the criminal conviction must be graded higher than a summary offense ''in this Commonwealth or the lowest-graded criminal offense in another State or country.'' This proposed change provides the same clarity to applicants as the proposed change to subsection (b)(6)(iv)(B).

Subsection (c).

 This proposed subsection mirrors the current subsection (c). It provides that if the Department determines that an initial permit application is complete but lacking information, the Department may, but is not obligated to, request the additional information from the applicant. Once contacted, an applicant has 30 days to provide the additional documentation.

Subsection (d).

 This proposed subsection mirrors the current subsection (d). It provides that the Department may, in its discretion, extend the deadline in proposed subsection (c) for up to an additional 15 days.

Subsection (e).

 This proposed subsection mirrors the current subsection (e). It specifies the Department's investigatory authority to inspect different facets of an applicant's site and compliance with the act and regulations, in addition to potentially interviewing individuals affiliated with the applicant's facility.

§ 1141a.30. Capital requirements

 This proposed section mirrors the current § 1141.30 (relating to capital requirements). This proposed section provides that a medical marijuana organization applicant must provide an affidavit, confirming that the applicant has the necessary amount of funds on deposit with one or more financial institutions.

§ 1141a.31. Background checks

 This proposed section replaces the current § 1141.31 (relating to background checks). While this proposed section largely tracks the current § 1141.31, this proposed section includes revisions to subsections (a) and (c), as detailed as follows.

Subsection (a).

 This proposed subsection mirrors the provisions of the current subsection (a), except for changing the citation to refer to this proposed chapter. This proposed subsection provides the way the Department will conduct criminal background checks on applicants and their affiliates.

Subsection (b).

 This proposed subsection mirrors the current subsection (b). This proposed subsection provides that the Department will only use the criminal background check for the limited purpose of determining character, fitness and suitability to serve in the individual's designated capacity.

Subsection (c).

 This proposed subsection exempts from its provisions an owner of a publicly traded company, except in certain circumstances. The current subsection (c) provides that § 1141.31 does not apply to an owner of securities in a publicly traded company ''if the Department determines that the owner is not substantially involved in the activities of the medical marijuana organization.'' The Department proposes to revise this subsection to omit the previously-quoted language. In making this revision, the Department proposes that proposed § 1141a.31 will not apply to an owner of securities in a publicly traded company ''unless the owner holds 5% or more of the company's securities or the owner has voting rights to elect or appoint one or more members of the board of directors or other governing board.'' This proposed change provides clarity with respect to who is exempt from background checks.

§ 1141a.32. Diversity goals

 This proposed section mirrors the current § 1141.32 (relating to diversity goals), except for changing the citation in proposed subsection (g) to refer to this proposed chapter. This proposed section outlines the Department's intent that medical marijuana organizations establish practices and procedures for promoting and ensuring diversity. Under this proposed section, applicants are required to include in their application a diversity plan, including contracts with diverse vendors, efforts to recruit diverse participants, and the diversity in the applicant's workforce. The Department will review the diversity plans submitted by applicants for viability. Applicants must also include in the renewal applications information of their efforts to meet their diversity goals and the effectiveness of its diversity plan.

§ 1141a.33. Review of initial permit applications

 This proposed section mirrors the current § 1141.33 (relating to review of initial permit applications), except for changing the citation in proposed subsection (a) to refer to this proposed chapter. This proposed section provides that the Department will review initial permit applications in accordance with section 603(a.1) of the act (35 P.S. § 10231.603(a.1)) and the factors in proposed § 1141a.24(b) (relating to medical marijuana regions). Further, the Department will publish the number of permits and the locations thereof in the Pennsylvania Bulletin.

§ 1141a.34. Denial of permit

 This proposed section mirrors the current § 1141.34 (relating to denial of a permit), except for changing the citations in proposed paragraphs (3) and (8) to refer to this proposed chapter. This proposed section delineates the grounds upon which the Department will deny the issuance of a permit to an applicant.

§ 1141a.35. Notice of denial

 This proposed section mirrors the current § 1141.35 (relating to notice of denial), except for amending a citation to refer to proposed Chapter 1230a (relating to practice and procedure). Under this proposed section, the Department will provide written notice of denial to an applicant, and the applicant may then appeal a notice of denial.

§ 1141a.36. Permit renewal applications

 This proposed section mirrors the current § 1141.36 (relating to permit renewal applications), except for changing the citation in proposed subsection (b) to refer to this proposed chapter. This proposed section provides the procedure for medical marijuana organizations applying for a permit renewal, in addition to specifying the information that must be included in the application.

§ 1141a.37. Denial of renewal of a permit

 This proposed section mirrors the current § 1141.37 (relating to denial of renewal of a permit), except for changing the citations in proposed subsections (b), (d) and (e) to refer to this proposed chapter. This proposed section provides the grounds upon which the Department will deny the renewal of a medical marijuana organization's permit and outlines the obligations of a medical marijuana organization should it fail to file a permit renewal application or should the Department deny its application for a renewal permit.

§ 1141a.38. Duty to report

 This proposed section largely tracks the provisions in current § 1141.38 (relating to duty to report), with two exceptions, as detailed as follows. This proposed section outlines the circumstances under which an applicant must report changes of information during the application process to the Department.

 First, consistent with the revisions to proposed § 1141a.39 (relating to application for change in ownership of a medical marijuana organization), the Department proposes to amend subsection (b) to reflect that medical marijuana organizations only need to submit an application for a change in ownership, as opposed to an application for approval of a change of ownership. This revision reflects the fact that the Department does not approve equity transactions of medical marijuana organizations. Instead, the Department only approves the suitability of the individuals affiliated with medical marijuana organizations. Second, the citations in subsections (b) and (c) are revised to refer to this proposed chapter.

§ 1141a.39. Application for change in ownership of a medical marijuana organization

 This proposed section replaces the current § 1141.39 (relating to application for approval of a change in ownership of a medical marijuana organization). This proposed section substantially amends the provisions in current § 1141.39, as detailed as follows.

Title.

 This proposed section omits the words ''approval of a'' from the title of current § 1141.39. Consistent with the proposed amendments to § 1141a.38 discussed previously, the Department proposes to clarify that it only determines the suitability of the individuals affiliated with medical marijuana organizations and does not approve a medical marijuana organization's equity transaction.

Subsection (a).

 This proposed subsection provides that medical marijuana organizations are required to submit an application for change in ownership to the Department in the event of an impending change in ownership involving a change in control. This proposed subsection deviates from the current subsection (a) in two ways: (1) it omits the words ''approval of a'' when discussing the application for a change in ownership, for the same reasons as discussed previously; and (2) it revises the citation to refer to this proposed chapter.

Subsection (b).

 This proposed subsection provides that an application for a change of ownership will not be considered complete until the applicant pays the necessary fees. In replacing this subsection, the Department proposes to omit the current subsection (b) in its entirety, as it does not reflect the internal process currently used to evaluate affiliation of individuals with a medical marijuana organization. Proposed subsection (b) tracks the substantive requirements of the current subsection (c). This proposed subsection deviates from the current subsection (c) in three ways: (1) it omits the words ''approval of a'' when discussing the application for a change in ownership, for the same reasons discussed previously; (2) it revises the citation to refer to this proposed chapter; and (3) it deletes ''the Department may reject an incomplete application'' as this language does not reflect current practice.

Subsection (c).

 This proposed subsection mirrors the current subsection (d), except for revising the citation to refer to this proposed chapter. Under this proposed subsection, medical marijuana organizations will be required to provide all of the information required by proposed § 1141a.29 (relating to initial permit application) for each individual involved in the change of ownership.

Subsection (d).

 This proposed subsection provides that a medical marijuana organization's change in ownership without the Department's knowledge and written approval of all individuals affiliated with the medical marijuana organization would be a violation of the act and this proposed part. This proposed subsection is modeled after the current subsection (f). The Department works with the medical marijuana organization to obtain all necessary information. This proposed subsection revises the current subsection (f) and includes the amended language as proposed subsection (d). Current subsection (f) provides that a change in ownership occurring without the Department's ''prior written approval of the change as provided in this section'' is a violation, whereas this proposed subsection omits that language and provides that a change in ownership that occurs without the Department's ''knowledge and written approval of all individuals affiliating with the medical marijuana organization'' is a violation. This revision reinforces the fact that the Department only determines the suitability of the individuals affiliated with a medical marijuana organization and does not approve a medical marijuana organization's equity transactions.

 Finally, in proposing to replace current subsection (d), the Department proposes to delete current subsection (e) in its entirety to eliminate a process that is not currently utilized.

§ 1141a.40. Application for approval of a change in location of an operational facility

 This proposed section mirrors the current § 1141.40 (relating to application for approval of a change in location of a facility), with three exceptions, as detailed as follows. This proposed section provides the procedure in which an operational facility may apply to relocate. This proposed section outlines the applicant's responsibilities with respect to the content of the application, duties after receiving approval, and grounds for denial of an application. Compared to the current § 1141.40, this proposed section deviates in three ways: (1) it adds the word ''operational'' to the title and to subsections (a) and (b), consistent with the proposed revisions to §§ 1141a.27 and 1141a.28 (relating to general requirements for applications; and fees); (2) it deletes ''authorized under a permit'' from subsections (a) and (b), as the language is unnecessary; and (3) it revises subsection (a) to refer to this proposed chapter.

§ 1141a.41. Application for approval of alteration of a facility

 This proposed section mirrors the current § 1141.41 (relating to application for approval of alteration of a facility), except for changing the citation in proposed subsection (b) to refer to this proposed chapter. This proposed section provides that, as a general rule, a medical marijuana organization may not alter its facility after the issuance of a permit. This proposed section further provides that a medical marijuana organization wishing to make such an alteration must submit an application to do so if the proposed alteration involves one or more of the scenarios delineated in proposed subsection (b)(1)—(3).

§ 1141a.42. Failure to be operational

 This proposed section mirrors the current § 1141.42 (relating to failure to be operational), except for changing the citation in proposed subsection (d) to refer to this proposed chapter. This proposed section requires a medical marijuana organization to notify the Department that it is operational within 6 months from the date the Department issues the permit. The Department will then conduct an inspection to determine whether the medical marijuana organization is operational. Failure to adhere to its operational timeline will require the medical marijuana organization to create a plan of correction to become operational. If the medical marijuana organization fails to comply with its plan of correction within 90 days of the Department approving the plan, the Department may take disciplinary action.

§ 1141a.43. Closure of a facility

 This proposed section mirrors the current § 1141.43 (relating to closure of a facility), except for changing the citations in proposed subsections (c)(3) and (d) to refer to this proposed chapter. This proposed section outlines the procedure for a medical marijuana facility to close a facility. A medical marijuana organization that intends to close a facility must provide proper notice and a closure plan to the Department, which must be approved by the Department. This proposed section also lists activities in which a medical marijuana organization is prohibiting from engaging after providing notice of its intention to close a facility.

§ 1141a.44. Insurance requirements

 This proposed section mirrors the current § 1141.44 (relating to insurance requirements). This proposed section requires a medical marijuana organization to obtain and maintain an adequate amount of insurance coverage for its activities, facilities and equipment. This proposed section further provides that a medical marijuana organization must obtain and maintain adequate workers' compensation insurance coverage.

§ 1141a.45. Inspection and investigation

 This proposed section mirrors the current § 1141.45 (relating to inspection and investigation). This proposed section provides that the Department may conduct announced or unannounced inspections to ensure a medical marijuana organization's compliance with its permit, the act, and this proposed part, and specifies the elements of the inspections. This proposed section further provides the extent to which the Department and its authorized agents may inspect a facility. The proposed section also outlines the penalty for a medical marijuana organization's failure to provide immediate access to its facility.

§ 1141a.46. Reports

 This proposed section largely mirrors the current § 1141.46 (relating to reports), except for proposed revisions to subsection (a), as detailed as follows.

Subsection (a).

 This proposed subsection outlines the ongoing reports medical marijuana organizations must provide to the Department and details the required contents of the reports. Proposed revisions to subsection (a)(1) and (2) require dispensaries and growers/processors to report the ''average price per unit of medical marijuana products sold'' rather than the ''per-dose price.'' These revisions are necessary because a ''dose'' varies from one patient to another and from one product to another.

Subsection (b).

 This proposed subsection mirrors the current subsection (b), which provides that the Department will aggregate the information submitted through these reports and publish it on the Department's web site.

Subsection (c).

 This proposed subsection mirrors the current subsection (c), which provides that the Department may require ongoing reporting of operational and financial information.

Subsection (d)

 This proposed subsection mirrors the current subsection (d), which provides that the Department may require any reports necessary to carry out its responsibilities under the act and this proposed part.

§ 1141a.47. General penalties and sanctions

 This proposed section mirrors the current § 1141.47 (relating to general penalties and sanctions), except for two revisions, as detailed as follows. This proposed section outlines the penalties and sanctions the Department may impose for violations of the act and this proposed part, which range from a written warning to revocation of a permit. This proposed section further provides that individuals who assist in the violation of the act or this proposed part are subject to civil penalties.

 Proposed subsection (a) augments the list of reasons for which the Department may suspend or revoke a medical marijuana organization's permit by adding falsification of information on any application submitted to the Department. This proposed addition serves to underscore the Department's expectation that applicants be truthful in all submissions to the Department. The Department also proposes to delete the words ''temporary regulations'' from subsection (d). As this proposed rulemaking promulgates Chapter 1230a as permanent regulations, this deletion is a necessary byproduct.

§ 1141a.48. Training

 This proposed section mirrors the current § 1141.48 (relating to training), except that the content is reorganized to clarify that principals, as well as employees, who have direct contact with patients or caregivers or who physically handle medical marijuana plants, seeds and products must complete the training. This proposed section outlines who must undergo a 2-hour training course developed by the Department, in addition to the information that must be included in the training. This proposed section further provides that the Department will make its training course available at no cost to medical marijuana organizations, and medical marijuana organizations must retain the attendance records for the training and make them available to the Department upon request.

§ 1141a.49. Zoning

 This proposed section mirrors the current § 1141.49 (relating to zoning). This proposed section provides that medical marijuana organizations must meet the same municipal zoning and land use requirements as other similar facilities located in the same zoning district.

§ 1141a.50. Advertising by a medical marijuana organization

 This proposed section mirrors the current § 1141a.50 (relating to advertising by a medical marijuana organization). This proposed section provides that medical marijuana organizations must be consistent with applicable Federal regulations when advertising or marketing medical marijuana products, and before use, these materials must first be approved by the Department. This proposed section further provides that it does not apply to information provided by a grower/processor to a dispensary listing various medical marijuana products, instruments, and devices that the grower/processor is offering for sale to the dispensary.

§ 1141a.51. Technical advisories

 This proposed section mirrors the current § 1141.51 (relating to technical advisories). This proposed section provides that the Department may publish technical advisories in the Pennsylvania Bulletin to provide guidance with respect to the Department's interpretation of the act and this proposed part, but that the advisories would not have the force of law or regulation.

Chapter 1151a. Growers/Processors

 This proposed chapter replaces the current Chapter 1151 (relating to growers/processors—temporary regulations). Proposed new sections and amendments to sections of the current temporary regulations are discussed more fully as follows.

§ 1151a.21. Growers/processors generally

 This proposed section mirrors the current § 1151.21 (relating to growers/processors generally) except for changing the citation in proposed subsection (b)(1) to refer to this proposed chapter. This proposed section provides that a grower/processor is under a continuing obligation to meet the qualifications necessary to receive a permit. This proposed section further provides that a grower/processor may not engage in growing/processing operations prior to being deemed operational by the Department; nor may a grower/processor employ someone under the age of 18 to work at its facility.

§ 1151a.22. Plans of operation

 This proposed section contains three proposed amendments to the current § 1151.22 (relating to plans of operation), as detailed as follows. This proposed section provides that at the time the Department determines a grower/processor to be operational, the grower/processor must provide the Department a full and complete plan of operation for review. This proposed section also delineates the required components of this plan of operation and provides that a grower/processor shall make the plan of operation available to the Department upon request.

 This proposed section adds subsection (c), requiring a grower/processor to comply with its plan of operation. This addition will ensure that growers/processors comply with the plans of operation submitted to the Department, which provide guidance as to how a grower/processor will handle specific events. Further, this proposed section revises the language in subsection (a)(2)(ii) by replacing the word ''visitors'' with the phrase ''individuals requiring access to the facility.'' The Department proposes this revision to emphasize that grower/processor facilities are not open to the public and are not permitted to have non-essential visitors. Finally, this proposed section revises the citation in proposed subsection (a)(12) to refer to this proposed chapter.

§ 1151a.23. Grower/processor facilities

 This proposed section mirrors the current § 1151.23 (relating to grower/processor facilities), excepting a one-word change in subsection (b)(3). This proposed section provides that growing/processing operations must occur in a secure facility approved by the Department. This proposed section further delineates areas that must be marked with proper signage, in addition to requiring that loading and unloading of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana, or medical marijuana products into and from a transport vehicle must take place in an enclosed, secure, out of public sight area of the facility.

 This proposed subsection revises subsection (b)(3) with respect to signage for limited access areas. Current subsection (b)(3) requires that limited access areas have a sign that states ''Do Not Enter—Limited Access Area—Access Limited to Authorized Personnel and Escorted Visitors.'' This proposed subsection replaces the word ''visitors'' with ''individuals.'' The Department proposes replacement of the term ''visitor'' to accentuate the fact that grower/processor facilities are not open to the public and are not permitted to have non-essential visitors.

§ 1151a.24. Start-up inventory

 This proposed section replaces the current § 1151.24 (relating to start-up inventory). This proposed section contains multiple changes from the current provisions, as detailed as follows.

Subsection (a).

 This proposed subsection provides that a grower/processor may obtain seeds from outside this Commonwealth to secure its start-up inventory. A grower/processor may obtain seeds from outside this Commonwealth during (1) the 30-day period after the Department deems the grower/processor operational or (2) any 30-day window established by the Department if the Department deems it necessary. This proposed subsection is revised to remove references to ''immature medical marijuana plants'' as section 702(a) of the act (35 P.S. § 10231.702(a)) only permits the importation of seeds from outside this Commonwealth. The Department proposes the additional 30-day window to provide growers/processors more flexibility in acquiring seeds if the Department determines that importation of additional seeds is necessary. Importation of additional seeds may be necessary to fulfill anticipated demand of medical marijuana products, and to ensure an ample supply of important medicine to persons in this Commonwealth in need of it.

Subsection (b).

 Proposed subsection (b) mirrors the current subsection (b). This proposed subsection provides that a grower/processor may not obtain medical marijuana plants, as opposed to seeds, from outside this Commonwealth at any time.

Subsection (c)

 Proposed subsection (c) requires that a grower/processor record in the electronic tracking system any seeds that it receives during a 30-day period under proposed subsection (a) within 24 hours of receiving the seeds. This proposed subsection is revised to remove ''and immature medical marijuana plant'' as section 702(a) of the act only permits the importation of seeds from outside this Commonwealth.

Subsection (d).

 The current subsection (d) provides that ''[a]fter the 30-day period in subsection (a) a grower/processor shall only grow medical marijuana plants from seeds or immature medical marijuana plants located physically in its facility, or purchase seeds, immature medical marijuana plants or medical marijuana plants from another grower/processor.'' The proposed subsection (d), necessitated by the change to proposed subsection (a), modifies existing language to incorporate any additional 30-day window that may be provided for the importation of seeds.

§ 1151a.25. Access to grower/processor facilities

 The Department proposes several substantive changes to the current § 1151.25 (relating to visitor access to grower/processor facilities).

Title.

 Current § 1151.25 is entitled ''Visitor access to grower/processor facilities.'' This proposed section is entitled ''Access to grower/processor facilities.'' This change proposes removal of the term ''visitor'' to accentuate the fact that grower/processor facilities are not open to the public.

Subsection (a).

 This proposed subsection provides that grower/processor facilities may not be open to the general public. If someone who is not approved to enter a facility requires access to that facility for purposes related to the work of the facility, the individual will be required to sign a log detailing the need for entry and will also be required to wear a temporary identification badge while on site and in the facility. This proposed subsection clarifies who may have access to a facility and for what purpose.

Subsection (b).

 This proposed subsection requires individuals to present a government-issued photo identification to enter a grower/processor facility. The current subsection (b) provides that ''visitors'' must present proper identification; this proposed subsection replaces ''visitors'' with ''individuals,'' consistent with the Department's removal of the term ''visitor'' from the proposed regulations.

Subsections (c) and (d).

 These proposed subsections mirror the current provisions. Proposed subsection (c) provides that individuals under the age of 18 are not permitted in a grower/processor facility. Proposed subsection (d) provides that a grower/processor must post proper signage at its facility.

Subsection (e).

 This proposed subsection largely mirrors the current subsection (e), with some minor changes. This proposed subsection provides the Department's expectations of a grower/processor that is admitting an individual into its facility. The changes from the current subsection include: (1) replacing the word ''visitor'' with ''individual,'' and (2) requiring that the individual detail the need for entry in the log. These changes are consistent with the Department's intent to remove the word ''visitor'' where possible, and to ensure that individuals entering grower/processor facilities are entering for the proper reasons.

Subsection (f).

 This proposed subsection provides the content and retention requirements for the log that individuals must sign upon entry to a grower/processor facility. Consistent with the rest of this proposed section, this proposed subsection changes the wording of the current regulations by replacing the word ''visitor'' with words or phrases similar to corresponding revisions to other subsections in this section.

Subsection (g).

 This proposed subsection mirrors the current regulatory provision. This proposed subsection provides that nothing in proposed § 1151a.25 will limit the right of the Department or its authorized agents, State or local law enforcement or other Federal, State or local government officials, from entering any area of a grower/processor site or facility, if entrance is necessary to perform their functions and duties that pertain to the act or this proposed part.

Subsection (h).

 This proposed subsection provides that grower/processor employees or other affiliated persons may not be compensated for granting access to a limited access area. The only change to the language of the current subsection (h) is the Department's proposal to replace the word ''visitor'' with ''individual,'' consistent with the rationale explained previously.

§ 1151a.26. Security and surveillance

 This proposed section mirrors the current § 1151.26 (relating to security and surveillance), except for two changes, as detailed as follows. This proposed section details the requirements of a grower/processor's security and surveillance systems and the inspection and servicing requirements. This proposed section further provides requirements with respect to access to rooms containing security and surveillance monitoring equipment and access.

 This proposed section amends the current regulation in two ways. First, proposed subsection (b)(5) permits more than one employee to be assigned to monitor the security system, whereas the current subsection only permits one employee to be assigned. Second, proposed subsection (d) requires that all entrances to and exits from a grower/processor facility must be securely locked ''at all times,'' as opposed to only during nonworking hours, as provided by the current subsection. The Department proposes these changes to ensure the safety and security of a grower/processor facility.

§ 1151a.27. Requirements for growing and processing medical marijuana

 This proposed section mirrors the current § 1151.27 (relating to requirements for growing and processing medical marijuana), except for amending two subsections, as detailed as follows. This proposed section provides that a grower/processor may only use pesticides, fungicides and herbicides approved by the Department of Agriculture and that the Department will periodically publish the list of approved pesticides, fungicides and herbicides in the Pennsylvania Bulletin. This proposed section also requires a grower/processor to use approved pesticides, fungicides and herbicides in a manner approved by the Department of Agriculture based on Federal law and regulations. A grower/processor must also log all actions taken to detect pests or pathogens and the measures taken for control. This proposed section requires a grower/processor to: use appropriate nutrient practices; use fertilizer as appropriate to support healthy plant growth; and maintain records of fertilizer and growth additives used.

 This proposed section amends two subsections in the current § 1151.27. First, the phrase ''additional active ingredients or materials'' in current subsection (f) is replaced with the newly-defined term ''added substance'' for the purposes of clarity. Further, proposed subsection (f) adds subparagraphs (i) and (ii) to provide guidance on what the Department will consider when determining whether to approve an added substance. Second, the current subsection (h)(3) provides that growers/processors only process parts of the medical marijuana plant that ''[c]ontain a level of mold, rot or other fungus or bacterial diseases acceptable to the Department.'' The proposed subsection changes that language to more clearly read that a grower/processor may only process parts of the medical marijuana plant that ''[d]o not contain levels of mold, rot or other fungus or bacterial diseases above the minimum levels acceptable to the Department.''

§ 1151a.28. Forms of medical marijuana

 This proposed section mirrors the current § 1151.28 (relating to forms of medical marijuana). This proposed section lists the six acceptable forms of medical marijuana that a grower/processor may process, in addition to providing that a grower/processor may not manufacture, produce or assemble any medical marijuana product, instrument or device without the prior written approval of the Department.

§ 1151a.29. Limit on medical marijuana processing

 This proposed section mirrors the current § 1151.29 (relating to limit on medical marijuana processing), excepting the revisions noted as follows. This proposed section provides that medical marijuana or medical marijuana products must have a specific concentration of total THC and total CBD, in addition to reporting the concentrations of delineated cannabinoids and listing them on the product's label. Further, this proposed section provides that within 6 months after the Department deems a grower/processor to be operational, a grower/processor must provide the Department a forecast of its medical marijuana production and form and notify the Department of potential increases or decreases within the following 6 months.

 This proposed section differs from the current § 1151.29 in two ways. First, proposed subsection (a) is revised to replace the full name of each cannabinoid on the product label with the abbreviation—as each is a defined term—in addition to requiring that the amount of Delta-8 THC be disclosed on the product label. These revisions are aimed at providing transparency with respect to the cannabinoids in medical marijuana products.

 Second, proposed subsection (b) requires a grower/processor to ''promptly'' notify the Department of anticipated increases or decreases in production; the current subsection (b) requires the grower/processor to notify the Department ''immediately.'' This proposed amendment provides a slightly expanded time frame for a grower/processor to notify the Department of a potential increase or decrease in production of medical marijuana or medical marijuana products.

§ 1151a.30. Inventory data

 This proposed section mirrors the current § 1151.30 (relating to inventory data). This proposed section specifies the data elements to be included in a grower/processor's inventory and requires a grower/processor to maintain the listed data in its electronic tracking system, in addition to requiring that a grower/processor establish inventory controls, and that the inventory information be maintained in an electronic record.

§ 1151a.31. Storage requirements

 This proposed section mirrors the current § 1151.31 (relating to storage requirements), except for amending a citation in subsection (a) to refer to this proposed chapter. This proposed section requires a grower/processor to ensure that its facility maintains a locked storage area for its products, and that these areas are kept in a clean and orderly condition.

§ 1151a.32. Equipment, operation and maintenance

 This proposed section mirrors the current § 1151.32 (relating to equipment, operation and maintenance). This proposed section requires a grower/processor to: have a written process in place to maintain the sanitation and operation of its equipment, which must be provided to the Department upon request; routinely calibrate equipment used in operations; and maintain a log regarding the maintenance, cleaning and calibration of its equipment.

§ 1151a.33. Sanitation and safety in a facility

 This proposed section mirrors the current § 1151.33 (relating to sanitation and safety in a facility), except that ''28 Pa. Code'' is added to correct the incomplete citation in subsection (b). This proposed section requires that a grower/processor maintain sanitary conditions to limit potential for contamination, in accordance with the requirements listed in subsection (a), including, for example, frequent cleaning and sanitizing, proper removal of trash and protection against pests. Further, this proposed section states that any employee coming into direct contact with medical marijuana is subject to restrictions in 28 Pa. Code § 27.153 (relating to restrictions on food handlers). This proposed section also requires a grower/processor to provide potable water, cleansers and handwashing facilities, as well as clean restroom facilities. Finally, this proposed section requires a grower/processor to comply with State and local building codes.

§ 1151a.34. Packaging and labeling of medical marijuana products

 This proposed section makes several substantive changes to the current § 1151.34 (relating to packaging and labeling of medical marijuana products), as described as follows.

Subsection (a).

 This proposed subsection, which mirrors the current subsection (a), provides that a grower/processor must package and label its products at its facility, and that the original seal may not be broken except for testing purposes at an approved laboratory.

Subsection (b).

 This proposed subsection lists the general requirements for medical marijuana product packaging. The current subsection (b)(3) provides that packaging must be ''[l]ight resistant or opaque, or both.'' This proposed subsection revises that provision and requires that packaging be opaque and removes the option to be ''light resistant.'' This revision effectuates the Department's intent that packaging not be transparent.

Subsection (c).

 This proposed subsection, which mirrors the current subsection (c), requires a grower/processor to identify each process lot of medical marijuana with a unique identifier.

Subsection (d).

 This proposed subsection requires that all packaging and labeling be approved by the Department and sets out the information that must be included on each label. The Department proposes to expand upon the requirements in the current subsection (d) by: (1) requiring that all packaging receive prior written approval of the Department; (2) requiring labels to list the species and percentages of all cannabinoids and individual terpenes; (3) requiring that labels be firmly affixed to the container directly holding medical marijuana as well as outer packaging; and (4) requiring that THC be the first number in a THC:CBD ratio, when the labeling includes a ratio. These revisions minimize patient confusion caused by medical marijuana packaging, and also ensure that individuals and law enforcement officials can readily determine if a medical marijuana product was purchased at a dispensary. This proposed subsection otherwise mirrors the current subsection (d), except for technical revision to subsection (d)(2) to correct syntax.

Subsection (e).

 This proposed subsection mirrors the current subsection (e). This proposed subsection specifies the design and other elements that may not be included on a label.

§ 1151a.35. Transportation of medical marijuana

 This proposed section mirrors the current § 1151.35 (relating to transportation of medical marijuana), with one exception in subsection (b)(4).

Subsection (a).

 This proposed subsection provides the guidelines for the transportation of medical marijuana and medical marijuana products—transporting only between specified hours; allowing for third-party contracting; prohibiting transport outside this Commonwealth; and requiring use of GPS tracking.

Subsection (b).

 This proposed subsection requires the vehicles used to transport medical marijuana to be insured, unmarked and temperature controlled with secure cargo areas. The current subsection (b)(4) requires that vehicles engaged in the transportation of medical marijuana ''[d]isplay current State inspection stickers and maintain a current State vehicle registration.'' This proposed subsection revises that provision to read that transportation vehicles must ''[m]aintain current State inspection and vehicle registrations.'' This revision allows for the possible elimination of inspection stickers in the future, as has been done with registration stickers.

Subsection (c).

 This proposed subsection requires medical marijuana transport vehicles to be staffed with at least two individuals, one of whom must always remain with the vehicle, who: are licensed drivers, wear plain clothing, carry identification and have access to communication.

Subsections (d)—(h).

 These proposed subsections provide that transportation vehicles are subject to inspection and require: products in transport must be concealed from outside view; direct transportation from a grower/processor facility to a medical marijuana dispensary or laboratory where unloading must promptly occur; a grower/processor must immediately report to the Department any accidents, losses or diversions of product that occur during transport; and a grower/processor must daily notify the Department of its delivery schedule.

§ 1151a.36. Transport manifest

 This proposed section mirrors the current § 1151.36 (relating to transport manifest), except for revising one citation in subsection (c) to refer to this proposed chapter. This proposed section requires a grower/processor to generate and maintain an electronic transport manifest, documenting information involved in all deliveries. This transport manifest is subject to inspection by the Department upon request. Proposed subsection (a) details the information that must be contained in the manifest. Proposed subsection (b) details specific chain of custody requirements for the transportation of seeds, plants and other medical marijuana products. Proposed subsection (c) specifies the transportation requirements for seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products. Proposed subsection (d) requires a grower/processor to provide a copy of the manifest to the delivery recipient. Subsection (e) requires a grower/processor to provide a copy of the manifest to the Department and other governmental officials if requested.

§ 1151a.37. Transportation of seeds, immature medical marijuana plants and medical marijuana plants

 This proposed section mirrors the current § 1151.37 (relating to transportation of seeds, immature medical marijuana plants and medical marijuana plants), except for revising three cross-references in subsection (c) to refer to this proposed chapter. This proposed section provides a that grower/processor may only transport seeds, immature medical marijuana plants and medical marijuana plants within this Commonwealth.

§ 1151a.38. Evidence of adverse loss during transport

 This proposed section mirrors the current § 1151.38 (relating to evidence of adverse loss during transport), with one exception detailed as follows. This proposed section outlines a grower/processor's duties in the event of an unresolved discrepancy in the transport manifest upon delivery. This proposed section also requires a grower processor to report suspected theft or diversion of product to the Department; to investigate a discrepancy in the transport manifest; to amend its plan of operation if necessary to prevent future discrepancies; and to submit a report of the investigation to the Department.

 The current subsection (a) provides that a grower/processor must refuse acceptance of a delivery in the event of any discrepancy in the transport manifest. Proposed subsection (a) requires a grower/processor to refuse delivery only when the discrepancy has not been resolved. This revision eliminates unnecessary delay in product delivery to dispensaries and, ultimately, to patients.

§ 1151a.39. Electronic Tracking System

 This proposed section provides that a grower/processor must use an electronic tracking system prescribed by the Department. This proposed section mirrors the current § 1151.39 (relating to electronic tracking system), except for omitting the obsolete language that the Department will provide notice of the electronic tracking system to be used by growers/processors, as the Department published this information in the Pennsylvania Bulletin at the time the system was implemented.

§ 1151a.40. Management and disposal of medical marijuana waste

 This proposed section mirrors the current § 1151.40 (relating to management and disposal of medical marijuana waste). This proposed section provides the obligations of a grower/processor with respect to the collection, storage and disposal of medical marijuana waste. Specifically, all unused, surplus, returned, contaminated or expired medical marijuana waste must be rendered unusable and incapable of ingestion and composted or disposed of according to municipal waste procedures or according to laws pertaining to hazardous waste.

§ 1151a.42. Complaints about or recall of medical marijuana products

 This proposed section mirrors the current § 1151.42 (relating to complaints about or recall of medical marijuana products), with two exceptions, as detailed as follows. This proposed section provides that in the event of a complaint of an adverse event from using medical marijuana, a dispensary must notify the Department and the grower/processor from which it purchased the medical marijuana and outlines the grower/processor's subsequent investigatory and reporting obligations. Further, this proposed section addresses processes and procedures in the event of a voluntary or mandatory recall of medical marijuana or medical marijuana products, subject to penalties for noncompliance; specifies the information that must be entered into the electronic tracking system; and specifies the requirements of a recall plan.

 This proposed section includes two amendments to the current regulations. First, proposed subsection (a)(1) requires that growers/processors ''immediately'' investigate complaints; the current regulation does not impose this immediacy requirement. Second, this proposed section adds subsection (h), authorizing the Department to initiate a mandatory recall upon receipt of information that any medical marijuana product poses a risk to public health and safety. These amendments underscore the Department's goals of product quality and patient safety.

§ 1151a.43. Pesticides

 This proposed section mirrors the current § 1151.43 (relating to pesticides), except that language was added in subsection (d) to clarify that the Department of Agriculture, which enforces the Pennsylvania Pesticide Control Act of 1973 (Pesticide Control Act) (3 P.S. §§ 111.21—112), coordinates with the Department. This proposed section requires that the use of pesticides by a grower/processor be in accordance with the applicable laws in this Commonwealth, subject to oversight by the Department and the Department of Agriculture. Further, this proposed section outlines the recordkeeping, record retention and record production requirements associated with pesticide application, prescribes the pesticide active ingredients that a grower/processor may use, and defines terms relevant to this proposed section, including select terms used in the statutes cited in this proposed section.

§ 1151a.44. Treatment and quarantine orders

 This proposed section mirrors the current § 1151.44 (relating to treatment and quarantine orders). This proposed section provides that the Department, in conjunction with the Department of Agriculture, may issue and carry out a treatment order against a grower/processor in the event that the grower/processor fails or refuses to eradicate a plant pest found at its facility. Further, this proposed section permits the Department of Agriculture, acting with the cooperation of the Department, to establish a quarantine if necessary to prevent the dissemination of plant pests and outlines the requirements in the event a quarantine is established.

Chapter 1161a. Dispensaries

 This proposed chapter replaces the current Chapter 1161 (relating to dispensaries—temporary regulations). Proposed new sections and amendments to sections of the current temporary regulations are discussed more fully as follows.

§ 1161a.22. Dispensaries generally

 This proposed section mirrors the current § 1161.22 (relating to dispensaries generally), except for revising a citation in subsection (b)(1) to refer to proposed Chapter 1141a. This proposed section provides that a dispensary is under a continuing obligation to meet the qualifications necessary to receive a permit. This proposed section further provides that a dispensary may not engage in dispensing operations prior to being deemed operational by the Department, may not employ someone under 18 years of age, and may not allow a patient to administer medical marijuana in the facility unless the patient is also an employee.

§ 1161a.23. Dispensing medical marijuana products

 This proposed section mirrors the current § 1161.23 (relating to dispensing medical marijuana products). This proposed section provides that a dispensary may only dispense to individuals who present a valid identification card; specifies the necessary prerequisites the dispensary must complete before dispensing medical marijuana products and before completing a transaction, including information that must be listed on a receipt and recordkeeping requirements.

§ 1161a.24. Limitations on dispensing

 This proposed section mirrors the current § 1161.24 (relating to limitations on dispensing). This proposed section provides that a dispensary may only dispense medical marijuana or medical marijuana in a quantity or form provided for on the patient's certification and permitted by the act or these proposed regulations. This proposed section also prohibits a dispensary from dispensing more than a 30-day supply of medical marijuana to a patient and not before the patient has exhausted all but a 7-day supply of medical marijuana.

§ 1161a.25. Licensed medical professionals at facility

 This proposed section mirrors the current § 1161.25 (relating to licensed medical professionals at facility), with one addition, as detailed as follows. This proposed section provides that a physician or pharmacist must be present at the facility during operating hours and, if a permittee operates more than one facility under the same permit, a physician assistant or certified nurse practitioner may cover the other sites. Further, this proposed section provides training requirements and continuing education standards for physicians, pharmacists, physician assistants and certified nurse practitioners. This section also prohibits a practitioner or physician from issuing patient certifications while at the facility.

 Compared to the current § 1161a.25, proposed subsection (b) provides that a facility's ''physician, pharmacist, physician assistant and certified registered nurse practitioner may rotate coverage of facilities as long as a physician or pharmacist is always present at one of the facilities.'' This addition clarifies that a dispensary authorized to operate more than one facility may allow the physician and pharmacist to rotate coverage to the secondary and tertiary dispensaries, as opposed to being limited to covering only the primary location.

§ 1161a.26. Dispensary facilities

 This proposed section modifies the current § 1161.26 (relating to dispensary facilities) in two ways, as detailed as follows. This proposed section imposes restrictions with respect to dispensary facilities and amenities. It also provides that individuals under 18 years of age may not enter a dispensary unless the individual is a patient or accompanied by a parent, guardian or caregiver. This proposed section further provides signage requirements for specific areas of the facility.

 This proposed section amends the current regulations in two ways. First, proposed subsection (b)(1) provides that a dispensary may not be located within 1,000 feet of ''a public, private or parochial school, or a day-care center providing services to children under 18 years of age, measured from the property line of a public, private or parochial school nearest to the dispensary to the nearest physical wall of the dispensary.'' This change clarifies that ''school'' is not intended to mean post-secondary schools and further defines how the 1,000-foot setback will be measured. This proposed section retains the authority of the Department to waive this requirement.

 Second, proposed subsection (e)(1) provides that signage in limited access areas must state that access is limited to authorized personnel and escorted ''individuals,'' as opposed to the word ''visitors'' found in the current subsection (e)(1). This change is proposed to remove references to ''visitors'' wherever possible, as discussed elsewhere in this preamble.

§ 1161a.27. Items and services provided at a dispensary

 This proposed section substantially revises the current § 1161.27 (relating to items and services provided at a dispensary), as detailed as follows.

Subsection (a).

 Beyond amending the regulatory citation to refer to this proposed chapter, this proposed subsection mirrors the current regulatory provision. This proposed subsection provides that a dispensary may only dispense medical marijuana in forms prescribed in proposed § 1161a.23(b)(2) (relating to dispensing medical marijuana products).

Subsections (b) and (c).

 These proposed subsections mirror the current subsections (b) and (c). These proposed subsections respectively provide that a dispensary may only purchase medical marijuana products from a grower/processor and that, with prior written approval from the Department, a dispensary may sell instruments, devices and services related to the use of medical marijuana products.

Subsection (d).

 Aside from revising one citation to refer to proposed Chapter 1151a (relating to growers/processors), this proposed subsection mirrors the current subsection (d). This proposed subsection provides that dispensaries may dispense a medical marijuana product with a THC concentration of less than 0.3% if purchased from a grower/processor that has obtained prior Department approval.

Subsection (e).

 This proposed subsection delineates prohibited actions for a dispensary. Specifically, dispensaries may not (1) provide medical marijuana product at no cost unless the patient is approved for financial assistance by the Department; (2) make purchases conditional upon the patient purchasing a medical device at the facility or a separate facility; (3) deliver, or contract with a third party to deliver medical marijuana; and (4) sell items and services unrelated to the use of medical marijuana products. This proposed subsection removes the current prohibition on advertising activities, as that provision caused confusion. The removal of this subsection does not, however, negate the general requirement in proposed § 1141a.50(b) (relating to advertising by a medical marijuana organization) that all promotional, advertising and marketing materials must be approved by the Department prior to use. Further, this proposed subsection revises the prohibition on delivering medical marijuana products by prohibiting a dispensary from contracting delivery to third parties, in addition to prohibiting a dispensary from delivering to a patient or caregiver, and by adding a prohibition on the sale of items unrelated to the use of medical marijuana. These revisions seek to limit the services a dispensary may provide to a patient or caregiver that are unrelated to the sale of medical marijuana products.

§ 1161a.28. Labels and safety inserts

 This proposed section mirrors the current § 1161.28 (relating to labels and safety inserts), with two exceptions, as detailed as follows. This proposed section sets forth the requirements of what must, and what may not, be listed on a label, in subsections (c) and (d), respectively, in addition to requiring, in subsection (b), that any product sold to a patient be fully sealed and labeled. Further, proposed subsection (c) requires a dispensary to inspect labels to ensure that the label contains all required information and is firmly affixed to the container holding medical marijuana, and proposed subsection (e) prescribes standards for safety inserts.

 Compared to the requirements in current § 1161.28, this proposed section adds the requirements that that all cannabinoids and terpenes and corresponding percentages be listed on the label and that a label be firmly affixed to a container directly holding medical marijuana. These revisions seek to ensure that law enforcement may readily discern the difference between packaging containing legitimate medical marijuana and illegal substances, in the event of a patient's interaction with law enforcement. In addition, the changes provide patients and caregivers with more information regarding the products they seek to purchase.

§ 1161a.29. Plans of operation

 This proposed section mirrors the current § 1161.29 (relating to plans of operation), with two exceptions, as detailed as follows. This proposed section provides that upon the Department determining a dispensary to be operational, the dispensary must provide the Department with its plan of operation. This proposed section outlines what must be included in a plan of operation and requires that a dispensary provide its plan of operation to the Department during inspections of the site and facility and at any time upon request.

 Proposed subsection (a)(2)(ii) replaces the word ''visitors'' with ''individuals requiring access to the facility.'' This change is proposed to remove references to ''visitors'' wherever possible, as discussed elsewhere in this preamble. Proposed subsection (c) adds the requirement that a dispensary comply with its plan of operation. This addition ensures that a dispensary adheres to the plan of operation submitted to the Department, in addition to informing the Department as to how a dispensary would handle specific events.

§ 1161a.30. Access to dispensary facilities

 The Department proposes several substantive changes to the current § 1161.30 (relating to visitor access to dispensary facilities), as detailed as follows.

Title.

 Current § 1161.30 is entitled ''Visitor access to dispensary facilities.'' This proposed section is entitled ''Access to dispensary facilities.'' This change proposes removal of the term ''visitor'' to emphasize that dispensaries are not open for general visitation.

Subsection (a).

 The current subsection (a) provides that a dispensary must post a sign at each entrance indicating that the premises are under constant video surveillance and that no one under 18 years of age is permitted to enter unless the individual is a patient or accompanied by a parent, guardian or caregiver. The proposed amendments include adding language to the sign indicating that only employees, patients and caregivers may enter, and that anyone under 18 years of age entering the dispensary must be a patient and accompanied by a parent. This proposed section clarifies that a dispensary is open only to employees, cardholders and individuals requiring access to provide goods or services.

Subsection (b).

 Proposed subsection (b) mirrors the current subsection (b) and provides that only authorized employees may enter limited access areas in a dispensary.

Subsection (c).

 Proposed subsection (c) requires individuals to present a government-issued photo identification to enter a dispensary. The current subsection (c) provides that ''visitors'' must present proper identification; this proposed subsection eliminates the word ''visitor'' consistent with the Department's removal of the term ''visitor'' from the regulations. The proposed new language clarifies that the subsection applies to any individual who is not approved to enter the facility who requires access to provide goods and services to the facility and requires the individual to sign a log and detail the need for entry to the facility.

Subsection (d).

 Proposed subsection (d) details a dispensary's obligations when admitting an individual to its facility, such as requiring the entrant to sign a log detailing the need for entry and to wear a temporary identification badge while in the facility. Similar to proposed § 1151a.25 (relating to access to grower/processor facilities), proposed subsection (d) revises the current subsection (d) to replace the term ''visitor'' with ''individual.''

Subsection (e).

 This proposed subsection provides the content and retention requirements for the log that individuals must sign upon entry to a dispensary. Consistent with the rest of this proposed section, this proposed subsection (e) changes the wording of the current subsection (e) by replacing the word ''visitor'' with words or phrases similar to corresponding revisions to other subsections in this section.

Subsection (f).

 Proposed subsection (f) mirrors the current subsection (f). This proposed subsection provides that nothing in proposed § 1161a.30 will limit the right of the Department or its authorized agents, or State or local law enforcement or other Federal, State or local government officials from entering any area of a grower/processor site or facility, if entrance is necessary to perform their functions and duties that pertain to the act or this proposed part.

Subsection (g).

 Proposed subsection (g) provides that dispensary employees or other affiliated persons may not be compensated for granting access to a limited access area. The only change to the language of the current subsection (d) is the Department's proposal to replace the word ''visitor'' with ''individual,'' consistent with the rationale explained previously.

§ 1161a.31. Security and surveillance

 This proposed section mirrors the current § 1161.31 (relating to security and surveillance), except for the changes detailed as follows. This proposed section requires that a dispensary establish and maintain security and surveillance systems to the specifications provided within this proposed section. Further, this proposed section prescribes lighting requirements and limits access to rooms containing surveillance monitoring equipment.

 This proposed section amends the current § 1161.31 in three ways. First, this proposed section allows dispensaries to designate multiple employees to continuously monitor the security and safety of a facility, whereas the current requirement only permits the designation of one employee. This revision provides dispensaries greater flexibility in ensuring the efficacy of their security systems while also not requiring the monitoring of these systems by a single person. Second, this proposed section requires that a dispensary install ''commercial grade, nonresidential doors and door locks'' on all external doors of the facility, which is not currently required by subsection (c). This change ensures the safety and security of each facility. Third, this proposed section requires that entrances to and exits from a dispensary be locked at all times, as opposed to just during nonworking hours, as currently required by subsection (d). This change seeks to ensure the safety and security of facilities.

§ 1161a.32. Inventory data

 This proposed section mirrors the current § 1161.32 (relating to inventory data). This proposed section lists the inventory information that must be maintained in the electronic tracking system, in addition to requiring a dispensary to establish inventory controls and conduct monthly reviews and annual comprehensive inventories, and specifies what information must be recorded as a result of inventory reviews.

§ 1161a.33. Storage requirements

 This proposed section mirrors the current § 1161.33 (relating to storage requirements), except for revising a citation in subsection (a) to refer to proposed Chapter 1151a. This proposed section provides that dispensaries must have separate and locked limited access areas for the storage of defective medical marijuana products, as described in this proposed section. This proposed section also provides that all storage areas must be maintained in a clean and orderly condition.

§ 1161a.34. Sanitation and safety in a facility

 This proposed section mirrors the current § 1161.34 (relating to sanitation and safety in a facility), except that except ''28 Pa. Code'' was added to correct the incomplete citation in subsection (b) and the word ''visitor'' was deleted from subsections (c) and (d) for the reasons explained elsewhere in this preamble. Proposed subsections (a) and (b) prescribe sanitation requirements and expectations for a dispensary facility and employees therein; proposed subsections (c) and (d) require adequate bathroom and hand-washing facilities; and proposed subsection (e) requires a dispensary to comply with all State and local building codes.

§ 1161a.35. Transportation of medical marijuana products

 This proposed section mirrors the current § 1161.35 (relating to transportation of medical marijuana products), with two exceptions, as detailed as follows. This proposed section provides that a dispensary may deliver medical marijuana products to medical marijuana organizations, subject to requirements delineated in proposed subsection (a). This proposed section also outlines the requirements with respect to the storage of medical marijuana products during transportation in proposed subsection (b); delivery drivers in proposed subsection (c); and transportation in proposed subsections (d) and (e). Further, proposed subsections (f) and (g) impose reporting requirements for specified events, and proposed subsection (h) subjects transport vehicles to inspection at the Department's request.

 The only amendments from the current regulation are in proposed subsection (b). Subsection (b)(1) requires that vehicles transporting medical marijuana products be ''equipped with a secure lockbox located within a locking cargo area,'' as opposed to the requirement in current subsection (b) that these vehicles be ''equipped with a secure lockbox or locking cargo area.'' This change clarifies that medical marijuana products are to be securely transported in a lockbox located within a locking cargo area to minimize opportunity for diversion. Further, proposed subsection (b)(4) requires that these vehicles maintain current State inspection and vehicle registrations, whereas the current regulation requires current vehicle registration and the display of a State inspection sticker. This revision allows for the possible elimination of inspection stickers in the future, as has been done with registration stickers.

§ 1161a.36. Transport manifest

 This proposed section mirrors the current § 1161.36 (relating to transport manifest), with one exception, as detailed as follows. Proposed subsections (a) and (b) provide that every transport vehicle shall generate a transport manifest, specifies the information that must be contained in the manifest and details requirements for delivery to multiple facilities. The one amendment to the current regulation is that proposed subsection (c) requires that seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products be transported in a secure lockbox located within a locked cargo area, whereas the current regulation requires that the product be packaged in a shipping container. Proposed subsection (d) requires a dispensary to provide a copy of the manifest to the delivery recipient. Subsection (e) requires a dispensary to provide a copy of the manifest to the Department and other governmental officials if requested. This amendment harmonizes this proposed section with the amendments to the requirements of proposed § 1161a.35 (relating to transportation of medical marijuana products) to prevent diversion.

§ 1161a.37. Evidence of adverse loss during transport

 This proposed section mirrors the current § 1161.37 (relating to evidence of adverse loss during transport), with one exception detailed as follows. This proposed section outlines a dispensary's duties in the event of an unresolved discrepancy in the transport manifest upon delivery. This proposed section also requires a dispensary to report suspected theft or diversion of product to the Department; to investigate a discrepancy in the transport manifest; to amend its plan of operation if necessary to prevent future discrepancies; and to submit a report of the investigation to the Department.

 The current subsection (a) provides that a dispensary must refuse acceptance of a delivery in the event of any discrepancy in the transport manifest. This proposed subsection (a) requires a dispensary to refuse delivery only when the discrepancy has not been resolved. This revision eliminates unnecessary delay in product delivery to dispensaries and, ultimately, to patients.

§ 1161a.38. Complaints about or recall of medical marijuana products

 This proposed section mirrors the current § 1161.38 (relating to complaints about or recall of medical marijuana products), except for revising a citation to refer to proposed Chapter 1151a. This proposed section provides that dispensaries must notify the Department and the grower/processor from which it purchased the medical marijuana product immediately upon becoming aware of a complaint made to the dispensary by an individual who experienced an adverse event resulting from interaction with a medical marijuana product. If the grower/processor were to recall the product, the dispensary is required to cease dispensing the item in question and coordinate a return of the recalled product.

§ 1161a.39. Electronic tracking system

 This proposed section provides that a dispensary must use an electronic tracking system prescribed by the Department. This proposed section mirrors the current § 1161.39 (relating to electronic tracking system), except for omitting the obsolete language that the Department will provide notice of the electronic tracking system to be used by growers/processors, as the Department published this information in the Pennsylvania Bulletin at the time the system was implemented.

§ 1161a.40. Application for additional dispensary locations

 This proposed section mirrors the current § 1161.40 (relating to application for additional dispensary locations), except for revising a citation to refer to proposed Chapter 1151a. This proposed section provides that an applicant for a dispensary permit may identify a primary location and up to two additional dispensary locations in its application or at a later date, using a form prescribed by the Department and following the initial permitting requirements set forth in proposed § 1114a.29 (relating to initial permit application), subject to subject to the payment of fees specified in subsection (c) and the Department's approval.

Chapter 1171a. Laboratories

 This proposed chapter replaces the current Chapter 1171 (relating to laboratories—temporary regulations). Proposed new sections and amendments to sections of the current temporary regulations are discussed more fully as follows.

§ 1171a.22. Laboratories generally

 This proposed section mirrors the current § 1171.22 (relating to laboratories generally), except for revising citations in subsection (a) to refer to this proposed chapter. This proposed section prohibits a laboratory from collecting or testing medical marijuana samples unless the laboratory has been approved by the Department under § 1171a.23 (relating to approval of laboratories) and has entered into a written contract with the grower/processor under § 1171a.29 (relating to testing requirements). This proposed section requires the Department to post a list of approved laboratories on its web site and provides general requirements with respect to: (1) laboratory duties; (2) director responsibilities and employee qualifications; (3) prohibitions on ownership; (4) duration of the Department's approval; and (5) nontransferability of the Department's approval.

§ 1171a.23. Approval of laboratories

 This proposed section mirrors the current § 1171.23 (relating to approval of laboratories), except for revising a citation in subsection (b)(8) to refer to this proposed chapter. This proposed section provides that a laboratory wishing to become an approved laboratory must submit a completed application to the Department, including the information required in proposed subsections (b) and (d), the submission of which amounts to consent to an investigation of any person, information, or location the Department deems appropriate to approve or deny the application. Under this proposed section, the Department may grant approval based upon its determination that the applicant is financially and professionally suitable to conduct the required testing.

§ 1171a.24. Suspension or revocation of an approval issued to a laboratory

 This proposed section mirrors the current § 1171.24 (relating to suspension or revocation of an approval issued to a laboratory). This proposed section provides that the Department may suspend or revoke a laboratory's approval if the laboratory engages in unethical practices, fails to maintain proper standards for reporting accuracy, or fails to comply with the act or this proposed part. Further, this proposed section delineates other conduct for which the Department may revoke a laboratory's approval.

§ 1171a.25. Renewal of an approval issued to a laboratory

 This proposed section mirrors the current § 1171.25 (relating to renewal of an approval issued to a laboratory), except for revising a citation to refer to this proposed chapter. This proposed section provides the timeframe in which an approved laboratory must submit an application for renewal.

§ 1171a.26. Stability testing and retention of samples

 This proposed section mirrors the current § 1171.26 (relating to stability testing and retention of samples). This proposed section provides that an approved laboratory must conduct required stability testing of samples collected from growers/processors to ensure product potency and purity and accurate expiration dating, and that the laboratory must properly store those tested samples for 1 year.

§ 1171a.27. Sampling procedures for testing

 This proposed section mirrors the current § 1171.27 (relating to sampling procedures for testing). Proposed subsection (a) requires a laboratory to ensure its employees follow established sample preparation procedures. Proposed subsections (b) and (c) outline the elements that a laboratory's policies and sampling procedures must include.

§ 1171a.28. Selection protocol for samples

 This proposed section mirrors the current § 1171.28 (relating to selection protocol for samples). This proposed section provides that an employee of an approved laboratory may only enter a grower/processor facility for the purpose of identifying and collecting samples, subject to procedures regarding chain of custody. This proposed section also specifies the samples that a laboratory employee must identify and collect from a grower/processor facility.

§ 1171a.29. Testing requirements

 The Department proposes several changes to the current § 1171.29 (relating to testing requirements), as detailed as follows.

Subsections (a) and (b).

 These proposed subsections mirror the current regulatory provisions. These proposed subsections provide that an approved laboratory must enter into a written contract with a growers/processor prior to conducting testing and submit a request for testing through the electronic tracking system.

Subsection (c).

 The current subsection (c) specifies that an approved laboratory must minimally test two samples at harvest and at process stages. This proposed subsection (c) amends the current subsection (c) by providing that one approved laboratory must conduct testing on the harvest sample and a different approved laboratory must conduct testing on the processed sample. This revision creates checks and balances in the testing process.

Subsections (d)—(f).

 These proposed subsections mirror the current regulatory provisions. These proposed subsections provide the minimum elements for which a laboratory must test; that testing samples must be conducted with a statistically significant number and size of samples and methodologies approved by the Department; and that testing is prohibited on samples in the delineated circumstances.

Subsection (g).

 This proposed subsection (g) specifies tracking and disposal requirements. Where the current subsection (g) requires that all tests be entered into the electronic tracking system, this proposed subsection (g) provides that only testing performed on samples of harvest lots and process lots must be entered into the electronic tracking system, which and allows for additional tests to be performed without being entered into the electronic tracking system. Many permittees have requested the ability to conduct additional testing prior to harvesting. Additionally, a citation has been amended to refer to this proposed chapter and the proposed Chapter 1151a.

§ 1171a.30. Standards for testing

 This proposed section mirrors the current § 1171.30 (relating to standards for testing). This proposed section requires that an approved laboratory follow the methodologies, ranges and parameters acceptable to the Department that are contained in the scope of the certificate of accreditation issued to the laboratory.

§ 1171a.31. Test results and reporting

 The Department proposes several changes to the current § 1171.31 (relating to test results and reporting), as detailed as follows, in addition to changing citations to reflect this proposed chapter and proposed Chapter 1151a.

Subsection (a).

 Aside from revising citations to refer to this proposed chapter, this proposed subsection (a) mirrors the current subsection (a). This proposed subsection lists the tests to which the testing requirements of the proposed chapter apply: testing on harvest lots and process lots.

Subsection (b).

 This proposed subsection (b) has been amended to clarify that only testing performed on harvest lots and process lots are required to be entered into the electronic tracking system. The current subsection (b) requires all test results to be entered into the system. This amendment allows a permittee to conduct additional testing outside of the two required to be entered into the system. Further, this proposed subsection (b) revises a citation to refer to this proposed chapter.

Subsection (c).

 This proposed subsection (c) mirrors the current subsection (c), except as detailed as follows. This proposed subsection (c) provides the procedure for a sample that fails testing. This proposed subsection allows a failed sample to be re-tested by the same laboratory. If the initially failed sample were then to pass re-testing, proposed subsection (c)(2) requires a different laboratory to confirm that passing test. Proposed subsection (c)(3) allows the Department to opt to reject the confirming result from the approved laboratory. The term ''confirming'' was added to subsection (c)(3) as a grammatical clarification. If the Department rejects the confirming result, or if the sample were to fail again, under proposed paragraph (3), the lot is required to be disposed of in accordance with proposed § 1151a.40 (relating to management and disposal of medical marijuana waste). Proposed paragraph (4) had been added to clarify the expectation that a re-tested sample that fails is required to be disposed of in accordance with proposed 1151a.40. Finally, citations have been amended to refer to this proposed chapter and proposed Chapter 1151a.

Subsection (d).

 This proposed subsection (d) mirrors the current subsection (d). This proposed subsection requires that a laboratory notify the Department and the approved laboratory of its intent to re-test a sample that failed a test or test another sample from the same harvest batch, harvest lot or process lot.

Subsection (e).

 This proposed subsection (e) requires a laboratory to provide a grower/processor a certificate of analysis that reports the results of the testing, which must include the delineated information. Compared to the current subsection (e), paragraph (1) of this proposed subsection utilizes defined abbreviations for certain chemical compounds, including compounds that have been added to the proposed paragraph (1), that must be included in the analysis, whereas the current subsection (e) provides the full names.

§ 1171a.32. Quality assurance program

 This proposed section mirrors the current § 1171.32 (relating to quality assurance program). This proposed section requires that an approved laboratory establish and implement a quality assurance program to ensure accuracy and delineates the components that the quality assurance program must include.

§ 1171a.33. Transporting samples

 This proposed section mirrors the current § 1171.33 (relating to transporting samples), except for revising citations in subsection (a) to refer to proposed Chapter 1151a. This proposed section requires that the samples must be transported in accordance with proposed §§ 1151a.35 and 1151a.36 (relating to transportation of medical marijuana; and transport manifest). Further, this proposed section requires that samples be transported from a grower/processor to an approved laboratory in a manner that adequately protects the integrity and composition of the samples from outside interference.

§ 1171a.34. Department request for testing

 This proposed section mirrors the current § 1171.34 (relating to Department request for testing). This proposed section provides that the Department, in its discretion, may identify and collect samples for testing by an approved laboratory, and the approved laboratory must provide a written report of the results within 7 days or sooner if requested by the Department.

§ 1171a.35. Laboratory reporting

 The Department proposed to make several changes to the current § 1171.35 (relating to laboratory reporting), as detailed as follows.

Subsection (a).

 This proposed subsection (a) lists the specific information a laboratory must enter into the electronic tracking system when testing a sample collected under proposed § 1171a.28(c) (relating to testing of samples from harvest lots and process lots). Compared to the current subsection (a), this proposed subsection (a) requires that only those tests conducted under proposed § 1171a.28(c), as opposed to all tests conducted, must be entered into the electronic tracking system. Additionally, citations are amended to refer to this proposed chapter.

Subsection (b).

 This proposed subsection provides that an approved laboratory maintain a certificate of analysis for 4 years and amends the current subsection to include those test results not required to be entered into the electronic tracking system. Additionally, proposed amendments to this subsection add paragraph (1), which requires an approved laboratory to immediately provide to the Department an electronic copy of a certificate of analysis for those test results that are not required to be entered into the electronic tracking system, and paragraph (2), which modifies the current subsection (b) to apply only to results entered into the electronic tracking system.

Subsection (c).

 This proposed subsection (c) provides that the Department may conduct an investigation based on the results of any certificate of analysis. This proposed subsection is added to ensure product quality and patient safety.

§ 1171a.36. Advertising.

 This proposed section mirrors the current § 1171.36 (relating to advertising). This proposed section prohibits a laboratory from advertising or promoting its services to the general public. This proposed section clarifies that personal solicitation by a laboratory employee is considered advertising or promotional marketing. It also provides that a laboratory may only advertise to a grower/processor those services performed on site, subject to prior Department approval. Further, this proposed section provides that a laboratory may erect signage at its facility, subject to compliance with local zoning requirements and this proposed section.

§ 1171a.37. Ownership prohibition

 This proposed section mirrors the current § 1171.37 (relating to ownership prohibition). This proposed section delineates those individuals who may not have a management, financial (direct or indirect) or other ownership interest in an approved laboratory.

§ 1171a.38. Appeals

 This proposed section mirrors the current § 1171.38 (relating to appeals), except for amending a citation to refer to proposed Chapter 1230a (relating to practice and procedure). This proposed section provides that all actions of the Department under this proposed chapter are governed by Chapter 5, Subchapter A of 2 Pa.C.S. (relating to practice and procedure of Commonwealth agencies) and its accompanying regulations, as modified by proposed Chapter 1230a.

Chapter 1181a. Physicians and Practitioners

 This proposed chapter replaces the current Chapter 1181 (relating to physicians and practitioners—temporary regulations). Proposed new sections and amendments to sections of the current temporary regulations are discussed more fully as follows.

§ 1181a.22. Practitioners generally

 This proposed section mirrors the current § 1181.22 (relating to practitioners generally), excepting three technical amendments, as detailed as follows. This proposed section requires that a practitioner meet continuing qualifications to be registered with the Department and may not issue patient certifications prior to becoming registered. This proposed section also requires a practitioner to notify a dispensary of a patient's adverse reaction to medical marijuana dispensed by that dispensary. Further, this proposed section permits a practitioner to petition the Board to review any proposed change to the currently listed serious medical conditions for which medical marijuana could be beneficial. Where the current § 1181a.22 provides that the Board will establish a procedure to effectuate this review process, this proposed section no longer contains that language, as the Board has already created that process. Additionally, a citation in proposed subsection (b) has been amended to refer to this proposed chapter, and a reference to the statute has been deleted in proposed subsection (d).

§ 1181a.23. Medical professionals generally

 This proposed section mirrors the current § 1181.23 (relating to medical professionals generally), except for revising a citation in subsection (b) to refer to this proposed chapter. This proposed section provides that, like the requirements for a registered practitioner, the requirements to be a registered medical professional are an ongoing responsibility to maintain. The proposed section also provides that a medical professional may not assume any duties at a dispensary until all requirements are satisfied. This proposed section further requires that a medical professional notify the practitioner listed on the patient certification of any adverse reaction suffered by the patient as a result of interaction with a medical marijuana product purchased at the dispensary.

§ 1181a.24. Physician registration

 The language in this proposed section substantively mirrors the current § 1181.24 (relating to physician registration), except for revising a citation in subsection (c) to refer to this proposed chapter but is reorganized for clarification. This section as currently written in the temporary regulation implies that that a physician may not apply for registration as a practitioner unless the physician holds an active, unrestricted medical license and is determined by the Department to be qualified to treat patients with serious medical conditions. The proposed section relocates the physician licensing requirement in current subsection (a)(1) to proposed subsection (a); deletes the current subsection (a)(2) and replaces it with proposed new subsection (c), to clarify that the Department determines approval to issue patient certifications based on the information submitted in the application; and revises the current subsection (c) to be proposed subsection (d). With this reorganization, the section more clearly provides for licensing qualifications to apply in subsection (a), followed by application requirements in subsection (b), and ending with a determination of approval to issue patient certifications based on the submitted application in subsection (c). This proposed section further provides that the Department may only list a physician on the practitioner registry after the physician has completed the training course required in proposed § 1181a.32 (relating to training) and met all other requirements for registration.

§ 1181a.25. Practitioner registry

 This proposed section mirrors the current § 1181.25 (relating to practitioner registry). This proposed section provides that the Department will maintain a practitioner registry for use by patients or caregivers, and that inclusion in the registry is subject to annual review by the Department to ensure that the practitioner remains qualified.

§ 1181a.26. Denial, revocation or suspension of a practitioner registration

 This proposed section mirrors the current § 1181.26 (relating to denial, revocation or suspension of a practitioner registration), except for revising a citation in subsection (c) to refer to this proposed chapter. This proposed section provides the grounds upon which the Department may deny, revoke or suspend a practitioner's registration. The proposed section also prohibits a physician who has been denied registration or has had that registration revoked or suspended from accessing, issuing, modifying or copying a patient's certification. Further, this proposed section provides that a physician may reapply if the circumstances leading to registration denial, revocation or suspension have resolved.

§ 1181a.27. Issuing patient certifications

 This proposed section mirrors the current § 1181.27 (relating to issuing patient certifications). This proposed section specifies the conditions under which a practitioner may issue a patient certification, as well as specifying the information that is required on a patient certification. This proposed section also requires a practitioner to provide a copy of a completed patient certification to the patient or the patient's caregiver and to the Department, as well as to retain a copy in the patient's file.

§ 1181a.28. Modifying a patient certification

 This proposed section mirrors the current § 1181.28 (relating to modifying a patient certification). This proposed section provides that a practitioner may not modify the form of medical marijuana products specified on a patient certification for 30 days from the date the receipt is entered into the electronic tracking system unless the practitioner notifies the Department. This proposed section also requires a practitioner to provide a copy of a modified patient certification to the patient or the patient's caregiver and to the Department, as well as to retain a copy in the patient's file.

§ 1181a.29. Revocation of a patient certification

 This proposed section mirrors the current § 1181.29 (relating to revocation of a patient certification). This proposed section provides that a practitioner must immediately notify the Department that a patient's circumstances have changed in a manner that would affect the patient's certification, for example, the patient no longer has the serious medical condition for which he or she was certified. The proposed section also provides that the Department will revoke the patient's certification upon receiving this notification. Further, this proposed section provides that a practitioner may withdraw the issuance of a patient certification at any time. The proposed section also provides that the Department will immediately notify the medical marijuana cardholder of a certification revocation and enter the information into the electronic tracking system.

§ 1181a.30. Prescription drug monitoring program

 This proposed section mirrors the current § 1181.30 (relating to prescription drug monitoring program). This proposed section requires a practitioner to review the Prescription Drug Monitoring Program prior to issuing or modifying a patient certification to determine whether the controlled substance history of the patient would impact the patient's use of medical marijuana products. The proposed section also specifies the reasons for which a practitioner may access the Prescription Drug Monitoring Program.

§ 1181a.31. Practitioner prohibitions

 This proposed section mirrors the current § 1181.31 (relating to practitioner prohibitions), except for adding subsection (g). This proposed section lists the prohibitions for practitioners, including: (1) accepting any form of remuneration for issuing patient certifications other than a fee for the patient consultation; (2) holding a direct or economic interest in a medical marijuana organization; (3) advertising as a certifying physician; (4) issuing a patient certification for personal use or for a family or household member; (5) acting as a caregiver for a patient certified by the practitioner; and (6) receiving or providing medical marijuana samples. In addition, proposed subsection (g) prohibits a practitioner from charging patients excessive fees. The Department is proposing the change due to patient complaints of practitioners taking advantage of the certification process by charging excessive lab testing, follow-up, or other fees not initially disclosed. Section 301(a)(11) of the act (35 P.S. § 10231.301(a)(11)) provides that the Department ''shall collaborate as necessary with other Commonwealth agencies or contract with third parties as necessary to carry out the provisions of this act.'' The Department will collaborate with the Department of State (DOS), which licenses physicians, and refer for investigation complaints that a practitioner is engaging in unscrupulous billing practices. The DOS will investigate and, if the DOS finds a violation of the Medical Practice Act of 1985 (63 P.S. §§ 422.1—422.51a), or the Osteopathic Medical Practice Act (63 P.S. §§ 271.1—271.18), the DOS will impose sanctions. If the DOS suspends, revokes, limits or otherwise restricts the practitioner's license, the practitioner will be removed from the medical marijuana physician registry under proposed § 1181a.26(a).

§ 1181a.32. Training

 This proposed section mirrors the current § 1181.32 (relating to training), except for revising a citation in subsection (a) to refer to this proposed chapter. This proposed section specifies those individuals who must complete a 4-hour training course prescribed by the Department and the requirements of that training course. Further, this proposed section provides that completion of the training course qualifies as continuing education credits by certain medical boards, and that individuals who completed the training course must submit documentation to that effect to the Department. Finally, this proposed section provides that the Department will provide on its web site a list of approved training providers.

§ 1181a.33. Appeals

 This proposed section mirrors the current § 1181.33 (relating to appeals), except for revising a citation to reflect proposed Chapter 1230a (relating to practice and procedure). This proposed section provides that all actions of the Department under this proposed chapter are governed by Chapter 5, Subchapter A of 2 Pa.C.S. and its accompanying regulations, as modified by proposed Chapter 1230a.

Chapter 1191a. Patients and caregivers

 This proposed chapter replaces the current Chapter 1191 (relating to patients and caregivers—temporary regulations). Proposed new sections and amendments to sections of the current temporary regulations are discussed more fully as follows.

§ 1191a.22. Patient and caregiver registry

 This proposed section mirrors the current § 1191.22 (relating to patient and caregiver registry), except for revising a citation in subsection (b) to refer to this proposed chapter. This proposed section provides that the Department will maintain a registry of patients and caregivers and lists the information that must be included in the registry. This proposed section also provides that the information contained in that registry is confidential and not subject to disclosure. Further, this proposed section provides that a caregiver may waive this confidentiality requirement and consent to providing the caregiver's name and contact information to the patient.

§ 1191a.23. Patients and caregivers generally

 This proposed section mirrors the current § 1191.23 (relating to patients and caregivers generally), except for revising a citation in subsection (b) to refer to this proposed chapter. This proposed section provides that the qualifications to become a patient or caregiver are ongoing qualifications, and the Department may issue a certification card to those individuals who meet those qualifications. Further, this proposed section provides that the Department may, with sufficient showing of suitability, allow a person under the age of 21 to serve as a caregiver. Finally, this proposed section provides that a minor patient shall have a caregiver who meets the criteria specified in subsection (d).

§ 1191a.24. Medical marijuana cardholder responsibilities

 The Department proposes several changes to the current § 1191.24 (relating to medical marijuana cardholder responsibilities), as detailed as follows.

Subsection (a).

 This proposed subsection (a) lists the circumstances under which a medical marijuana cardholder must immediately contact the Department. Specifically, those instances include: (1) change of the cardholder's name or address; (2) practitioner withdrawal of a patient certification; (3) a patient's decision to discontinue the services of a caregiver; (4) a decision of a caregiver to no longer serve in such a capacity for the patient; and (5) a decision by patient to discontinue treatment from the practitioner who issued the patient certification. This proposed subsection (a) amends the current subsection (a) in two ways: (1) corrects a typographical error (changing ''withdraw'' to ''withdrawal''); and (2) revises a citation to refer to the proposed § 1181a.29 (relating to revocation of a patient certification).

Subsection (b).

 This proposed subsection (b) replaces the current subsection (b) in its entirety and removes the current regulatory requirement that the cardholder must return the identification card upon receiving notification from the Department that the cardholder has been removed from the registry or the patient certification has been revoked. Returning the card is not necessary because the card will be inactivated and rendered unusable. This proposed subsection (b) provides that a medical marijuana cardholder must apply for a replacement identification card within 10 business days of discovering the loss or defacement of the identification card. This provision was moved from the current § 1191.28(f) (relating to identification cards) as it is more appropriate under this section detailing cardholder responsibilities.

§ 1191a.25. Application for, and issuance or denial of, identification cards

 This proposed section mirrors the current § 1191.25 (relating to application for, and issuance or denial of, identification cards), except for revising citations throughout to refer to this proposed chapter and proposed Chapters 1181a (relating to practitioners). This proposed section requires patient or caregiver identification card applicants to submit the proper application, complete with the information required in proposed subsections (b) and (d). Proposed subsection (c) details the procedure where an application designates a caregiver who is not authorized to serve as a caregiver. Applicants for a caregiver identification card are subject to a criminal background check and subsection (e) provides the grounds upon which an application may be denied.

 Proposed subsection (f) provides that the Department will notify the applicant of an incomplete application and of the additional information that is required. Proposed subsection (g) provides the applicant with 60 days to submit the requested information. Finally, proposed subsections (h) and (i) provide that the Department will notify an applicant in writing of the reasons for denial of an application, allow the applicant to submit a new application following that denial, and permit the Department to decline consideration of a re-application that does not correct previously identified deficiencies.

§ 1191a.26. Application fees

 This proposed section mirrors the current § 1191.26 (relating to application fees), except for two amendments, as detailed as follows.

Subsections (a) and (b).

 These proposed subsections (a) and (b) mirror the current subsections (a) and (b). These proposed subsections provide that an applicant may pay no more than one $50 fee in a 12-month period for an identification card, unless the applicant is submitting a renewal application within the same 12-month period or the applicant requires a replacement card, in which case the cardholder will pay $25 for a replacement card.

Subsection (c).

 This proposed subsection (c) provides that the Department may establish higher fees for the issuance of a second and subsequent replacement cards by publishing notice thereof in the Pennsylvania Bulletin. The current subsection (c) requires the Department to publish these fees every January. This proposed subsection eliminates the annual publication requirement if no changes are made.

Subsection (d).

 This proposed subsection (d) allows the Department to waive or reduce card fees for financial hardship and provides that the Department will publish on its web site the qualification for financial hardship. The current subsection (d) provides that this will occur every January. This proposed subsection eliminates the annual publication requirement if no changes are made.

§ 1191a.27. Criminal background checks

 This proposed section mirrors the current § 1191.27 (relating to criminal background checks). This proposed section requires an individual applying for an identification card as a caregiver submit to fingerprints to the Pennsylvania State Police for the purpose of obtaining a criminal background check. This proposed section also provides that the Department reviews the individual's criminal history only to determine the caregiver's character, fitness and suitability to serve in such a capacity.

§ 1191a.28. Identification cards

 This proposed section mirrors the current § 1191.28 (relating to identification cards), with one exception, as detailed as follows. This proposed section provides that the Department will issue identification cards as soon as practicable, and requires that the card contain certain delineated information, including a photograph of the cardholder. Subsection (c) provides that the Department will not require a photograph if the applicant submits a statement that a photograph cannot be provided due to the applicant's religious beliefs. Further, this proposed section outlines the circumstances under which an identification card issued to a patient or caregiver will expire. This proposed section omits the requirement in current subsection (f) that cardholders apply for a replacement card within 10 business days of discovering the loss or defacement of the card, as this requirement has been moved to proposed § 1191a.24(b) (relating to cardholder responsibilities).

§ 1191a.29. Renewing an identification card

 This proposed section mirrors the current § 1191.29 (relating to renewing an identification card), with two exceptions, as detailed as follows. This proposed section provides that a cardholder shall submit an application for card renewal no later than 30 days prior to the expiration of the current card, and that a cardholder shall obtain a new or updated certification. Further, this proposed section provides that the identification card will not be valid beyond the stated expiration date and the Department may remove the individual from the patient and caregiver registry if the Department denies a renewal application or if the cardholder fails to submit a renewal application.

 Compared to the current § 1191.29, proposed subsection (a) has been revised to require a medical marijuana cardholder to submit a new patient certification at the time the cardholder submits an application for a new identification card only if the certification is expired. This change is proposed because the time in which a patient must submit a new certification may not coincide with the time in which the patient must obtain a new identification card. Additionally, the citation in subsection (a) has been revised to refer to the proposed Chapter 1181a (relating to practitioners).

§ 1191a.30. Revocation or suspension of identification card

 This proposed section mirrors the current § 1191.30 (relating to revocation or suspension of identification card), except for the few revisions detailed as follows. This proposed section provides the instances in which the Department may suspend or revoke a cardholder's identification card and that, in such an instance, the Department will notify the cardholder of the Department's action. Further, this proposed section provides that if a patient's practitioner's registration has been revoked or suspended under proposed § 1181a.26 (relating to denial, revocation or suspension of a practitioner registration), or if a patient's practitioner withdraws the patient's patient certification under proposed § 1181a.29(c) (relating to revocation of a patient certification), the cardholder is required to obtain a new patient certification within 90 days of receiving notice from the Department or prior to the expiration of the identification card, whichever is sooner.

 Compared to the current § 1191.30, proposed subsection (c) has been revised to reflect that a patient does not need to apply for a new medical marijuana identification card when a practitioner's registration has been revoked or suspended or a practitioner withdraws the patient's certification under proposed § 1181a.29(c). Instead, proposed subsection (c) provides that a patient is required to obtain a new patient certification as explained previously. Additionally, citations have been amended throughout this section to refer to proposed Chapter 1181a (relating to practitioners).

§ 1191a.31. Obtaining medical marijuana products from a dispensary

 This proposed section mirrors the current § 1191.31 (relating to obtaining medical marijuana products from a dispensary), except for amending citations have been amended throughout this section to refer to proposed Chapters 1161a and 1181a (relating to practitioners; and dispensaries). This proposed section provides that a medical marijuana cardholder may only obtain medical marijuana products from a dispensary in accordance with proposed § 1161a.24 (relating to limitations on dispensing), and that the cardholder may only obtain medical marijuana products from a dispensary based on the recommendation provided in a valid patient certification that the dispensary may access through the electronic tracking system.

§ 1191a.32. Medical marijuana patient authorization letters

 This proposed section mirrors the current § 1191.32 (relating to medical marijuana patient authorization letters), except for revising a citation to refer to this proposed chapter and adding clarifying language to subsection (b), as detailed as follows. This proposed section provides that the Department will issue a medical marijuana patient authorization letter to a minor patient and may issue a patient authorization letter to an adult patient, instead of issuing an identification card. Proposed subsection (b) adds language to clarify that a patient authorization letter may be issued to an adult patient only when the patient's illness or infirmity permanently prevents the patient from visiting a dispensary. Further, this proposed section provides that when the minor patient who has been issued a patient authorization card turns 18 years of age, the patient is entitled to apply for an identification card. This proposed section also provides that a medical marijuana patient authorization letter confers the same rights and obligations, and is subject to the same terms and conditions, as apply to a medical marijuana cardholder, except that an identification card will be required for entry into a dispensary. Further, this proposed section provides that a patient who has been issued a medical marijuana patient authorization letter will not be required to pay an identification card application fee or an identification card renewal application fee.

 The medical marijuana patient authorization letter is not intended to, and may not be, a substitute for a medical marijuana identification card, which is required to access a dispensary. The patient authorization letter may be used only to signify authorization to be in possession of, or to consume, medical marijuana. It was developed because schools and child care programs have requested documentary evidence that minor patients, who cannot get a photo identification card from the Department of Transportation (PennDOT), the agency that verifies addresses in this Commonwealth for the issuance of a medical marijuana identification card, are permitted to consume medical marijuana. The letter does not afford access to a dispensary or authorize a caregiver to dispense medical marijuana. All patients holding a patient authorization letter must have a caregiver, who has an identification card, who visits the dispensary and obtains medical marijuana on the patient's behalf and delivers the medication to the patient. This letter is also used to accommodate homebound patients who also cannot obtain a PennDOT photo identification card. The Department also developed the patient authorization letter because it does not want to require payment for an identification card ($50 fee) from a patient who will never independently access a dispensary due to the patient's minor age or due to illness or infirmity that permanently prevents the patient from visiting a dispensary.

§ 1191a.33. Appeals

 This proposed section mirrors the current § 1191.33 (relating to appeals), except for revising a citation to reflect proposed Chapter 1230a (relating to practice and procedure). This proposed section provides that all actions of the Department under this proposed chapter are governed by Chapter 5, Subchapter A of 2 Pa.C.S., as modified by proposed Chapter 1230a.

Chapter 1211a. Clinical Registrants and Academic Research Centers

 This proposed chapter replaces the current Chapter 1211 (relating to clinical registrants and academic research centers—temporary regulations). Consistent with deleting the definition of ''certified ACRC'' from proposed Chapter 1141a, references to ''certified'' ACRC are removed from proposed §§ 1211a.25(b) and (d), 1211a.27(b)—(d), 1211a.27a, 1211a.30(c), 1211a.31(b), 1211a.32, 1211a.34 and 1211a.35. Other proposed amendments to sections of the current temporary regulations are discussed more fully as follows.

§ 1211a.22. Clinical registrants generally

 This proposed section mirrors the current § 1211.22 (relating to clinical registrants generally), except for revising citations to refer to this, and other, proposed chapters. This proposed section provides that the qualifications to be a clinical registrant are ongoing qualifications. Further, this proposed section outlines the process of becoming a clinical registrant, including holding or applying for dispensary and grower/processor permits. This proposed section provides that the Department will not approve more than eight clinical registrants, and the clinical registrant may not engage in dispensing activities until it receives Department approval. Further, this proposed section provides that an approved clinical registrant may not dispense medical marijuana products until determined to be operational by the Department and the clinical registrant demonstrates ability to begin research within 6 months of becoming operational. Finally, this proposed section provides that clinical registrants may dispense to a cardholders regardless of whether the patient is participating in a research study.

§ 1211a.23. Limitation on permits

 This proposed section mirrors the current § 1211.23 (relating to limitation on permits). This proposed section provides that an approved clinical registrant may not hold more than one dispensary and one grower/processor permit. Further, this proposed section provides that an approved clinical registrant may dispense medical marijuana at up to six separate locations, each of which must dispense medical marijuana to conduct research, and that no more than three of those locations may be in the same medical marijuana region or county.

§ 1211a.24. Capital requirements

 This proposed section mirrors the current § 1211.24 (relating to capital requirements), except for revising citations to refer to proposed chapters. This proposed section outlines the capital requirements for a clinical registrant applicant, which must be affirmed by means of affidavit submitted with the application to become a clinical registrant, along with a release to allow the Department to verify this information.

§ 1211a.25. Certifying ACRCs

 This proposed section mirrors the current § 1211.25 (relating to certifying ACRCs). This proposed section provides that the qualifications to become an ACRC are ongoing qualifications. This proposed section also provides that an accredited medical school may become approved to be an ACRC by application and that the Department will publish a notice in the Pennsylvania Bulletin announcing the availability of the application and the time period for applying. This proposed section specifies the information that must be included in an application and provides that the Department will publish a list of the certified ACRCs on its publicly available web site and in the Pennsylvania Bulletin.

§ 1211a.26. Revocation of a certification of an ACRC

 This proposed section mirrors the current § 1211.26 (relating to revocation of a certification of an ACRC). This proposed section outlines the circumstances under which the Department will revoke the certification of an ACRC. Further, should such an event occur, the Department will provide written notice of the action, and the ACRC will receive an opportunity to retain its certification by submitting proof of corrective action within 90 days of receiving the notice from the Department.

§ 1211a.27. Application for approval of a clinical registrant

 This proposed section mirrors the current § 1211.27 (relating to application for approval of a clinical registrant), except for revising citations to refer to this, and other, proposed chapters. This proposed section provides that an entity wishing to become a clinical registrant must apply to do so by means of application. This proposed section specifies the information that must be included in an application, some of which is confidential under the RTKL and not subject to disclosure. This proposed section also provides that the Department will publish a notice in the Pennsylvania Bulletin announcing the availability of the application and the time period for applying. This proposed section further provides that an applicant may only include one certified ACRC in its application for approval as a clinical registrant.

§ 1211a.27a. Research contracts

 This proposed section mirrors the current § 1211.27a (relating to research contracts). This proposed section provides that an applicant for approval as a clinical registrant shall provide with its application either (1) an executed agreement or (2) a letter of intent to enter into an agreement with a certified ACRC. This proposed section further provides that an applicant may submit more than one application, with separate applications identifying distinct certified ACRCs, and that although a certified ACRC may enter into a letter of intent with more than one clinical registrant applicant, it may only execute a research contract with one approved clinical registrant. Further, this proposed section provides that if more than one applicant for approval as a clinical registrant submits an application that includes a letter of intent with the same certified ACRC, the Department will follow the outlined prioritization in approving applications. Finally, this proposed section provides the minimum acceptable scores for a grower/processor and a dispensary permit application.

§ 1211a.28. Request for conversion of an existing permit

 This proposed section replaces the current § 1211.28 (relating to request for conversion of an existing permit), except for revising citations to refer to this, and other, proposed chapters. This proposed section provides that a dispensary or grower/processor permittee must submit a request for conversion of an existing grower/processor or dispensary permit with its application for approval as a clinical registrant. This proposed section further provides that upon approval as a clinical registrant, the clinical registrant will surrender its current dispensary or grower/processor permit, which will increase the number of available grower/processor or dispensary permits available to the commercial market. Finally, this proposed section provides that an applicant may include additional dispensary locations in its request for conversion of an existing permit or may request additional dispensary locations at a later date.

§ 1211a.29. Practices and procedures of research programs, projects or studies

 This proposed section mirrors the current § 1211.29 (relating to practices and procedures of research programs, projects or studies). This proposed section requires medical marijuana to be dispensed to a patient or caregiver as part of a research program in a form that conforms to the act or this proposed part. This proposed section further provides that medical marijuana may be dispensed from a clinical registrant directly to an ACRC in any form deemed safe by an IRB. This proposed section further provides requirements for research approval committees and IRBs, including (1) establishing policies and procedures, (2) reviewing research studies and (3) ensuring each research study addresses the issues specified in proposed subsection (e).

§ 1211a.30. Approval or denial of an application for approval of a clinical registrant

 This proposed section mirrors the current § 1211.30 (relating to approval or denial of an application for approval of a clinical registrant), except for revising citations to refer to this and other proposed chapters. This proposed section provides that an applicant shall be an approved clinical registrant upon the Department's approval of an application under proposed § 1211a.27 (relating to application for approval of a clinical registrant). This proposed section further provides that the Department may deny the application if the applicant has disclosed prior payments to a certified ACRC. This proposed section also specifies that prior to denying an application, the Department will issue written notice to the applicant and the applicant will have the opportunity to cure the prohibited payments by submitting to the Department a supplemental affidavit indicating that the certified ACRC or its affiliate has refunded to the applicant the prohibited payment. Further, this proposed section provides that an approved clinical registrant will have the same rights and obligations as a grower/processor or dispensary permittee, and a clinical registrant's dispensary and grower/processor permits will expire upon expiration, revocation or nonrenewal of the clinical registrant's approval.

§ 1211a.31. Renewal of approval of a clinical registrant

 This proposed section mirrors the current § 1211.31 (relating to renewal of approval of a clinical registrant), except for revising a citation to reflect proposed Chapter 1141a (relating to general provisions). This proposed section provides that the term of an approval of a clinical registrant will coincide with the term of the clinical registrant's grower/processor permit and dispensary permit, and that an approved clinical registrant will be required to renew its approval as part of its dispensary and grower/processor permit renewals. This proposed section further provides that the renewal application must be submitted on a form prescribed by the Department, must include the information specified in subsection (b), and is subject to Department approval. Finally, this proposed section provides that the Department will not renew approval for a clinical registrant if the Department determines that none of the clinical registrant's dispensary locations is engaging in research and does not intend to engage in research within 6 months of renewal.

§ 1211a.32. Revocation of approval of a clinical registrant

 This proposed section mirrors the current § 1211.32 (relating to revocation of approval of a clinical registrant), except for revising a citation to refer to this proposed chapter. This proposed section outlines the circumstances under which a clinical registrant's approval will be revoked, including revocation or suspension of the clinical registrant's grower/processor or dispensary permit, revocation of the partnered ACRC certification and lack of a research contract. This proposed section provides that the Department will issue written notice of its intention to revoke approval. Thereafter, the clinical registrant will have 90 days to contract with another certified ACRC that is not already contractually committed or have its approval revoked.

§ 1211a.33. Dispensing and tracking medical marijuana products

 This proposed section mirrors the current § 1211.33 (relating to dispensing and tracking medical marijuana products), except for revising a citation to refer to proposed Chapter 1161a (relation to dispensaries). This proposed section provides that the dispensary of an approved clinical registrant shall enter information into the electronic tracking system as required by the Department identifying patients who are enrolled in an approved research program or research study, in addition to entering information about medical marijuana products dispensed to all patients and caregivers.

§ 1211a.34. Prohibition

 This proposed section mirrors the current § 1211.34 (relating to prohibition). This proposed section provides that, except for reasonable remuneration specified in a research contract for the services to be performed or costs to be incurred by the certified ACRC, a certified ACRC may not solicit or accept anything of value from an approved clinical registrant or a principal or financial backer of an approved clinical registrant. Further, this proposed section clarifies that the prohibition does not apply to charitable contributions that are part of a history of giving to a certified ACRC established 1 year or more prior to the effective date of the act.

§ 1211a.35. Reporting requirements

 This proposed section mirrors the current § 1211.35 (relating to reporting requirements). This proposed section outlines when an approved clinical registrant must provide the Department a report of the findings of a research activity. This proposed section further provides that the Department will publish these findings on its publicly available web site and share them with other approved clinical registrants, ACRCs or other persons the Department determines would benefit from the findings.

§ 1211a.36. Sale or exchange

 This proposed section mirrors the current § 1211.36 (relating to sale or exchange), except for revising a citation to refer to this proposed chapter. This proposed section outlines the items a grower/processor of a clinical registrant may sell or exchange with another grower/processor and provides that a grower/processor of a clinical registrant may only sell its medical marijuana products to its own dispensary or to a dispensary owned by another clinical registrant. This proposed section further provides that an approved clinical registrant may petition the Department to sell its medical marijuana products to a dispensary in the commercial market and specifies that the petition must include the report required by proposed § 1211a.35 (relating to reporting requirements).

§ 1211a.37. Appeals

 This proposed section modifies the current § 1211.37 (relating to appeals), as detailed as follows. This proposed section provides that all actions of the Department under this proposed chapter are governed by Chapter 5, Subchapter A of 2 Pa.C.S. and its accompanying regulations, as modified by proposed Chapter 1230a (relating to practice and procedure). This proposed section amends the current § 1211.37 by adding the language that the accompanying regulations to 2 Pa.C.S. Chapter 5 (relating to practice and procedure), as modified by proposed Chapter 1230a, apply to the appeal process. This proposed section also revises the citation to refer to proposed Chapter 1230a.

Chapter 1230a. Practice and Procedure

 This proposed chapter replaces the current Chapter 1230 (relating to practice and procedure—temporary regulations). Proposed amendments to sections of the current temporary regulations are discussed more fully as follows.

§ 1230a.21. Scope

 This proposed section mirrors the current § 1230.21 (relating to scope). This proposed section provides that this proposed chapter and the General Rules of Administrative Practice and Procedure govern practice and procedure before the Department in medical marijuana appeals.

§ 1230a.22. Definitions

 This proposed section mirrors the current § 1230.22 (relating to definitions). This proposed section provides definitions not referenced in proposed § 1141a.21 (relating to definitions) and supplements the definitions in 1 Pa. Code § 31.3 (relating to definitions).

§ 1230a.23. Docket

 This proposed section mirrors the current § 1230.23 (relating to docket). This proposed section provides the general duties and address of the docket clerk for mailing of filings. Further, this proposed section provides that pleadings must be filed within prescribed time periods and are considered filed when received by the docket clerk. This proposed section also provides that the clerk will maintain the docket, that the docket is available for public inspection, and that proposed subsections (a) through (e) supersede 1 Pa. Code §§ 33.11 and 33.51 (relating to execution; and docket).

§ 1230a.24. Filing generally

 This proposed section mirrors the current § 1230.24 (relating to filings generally). This proposed section provides the general requirements for a filing to be accepted by the Department and provides for rejection or correction of deficient pleadings. This proposed section further provides that redundant, immaterial or inappropriate pleadings may be stricken before being accepted for filing.

§ 1230a.25. Effective date of adjudication, actions or order

 This proposed section mirrors the current § 1230.25 (relating to effective date of adjudication, actions or order). This proposed section provides that an adjudication, action or order is effective as of the date of mailing unless specifically provided otherwise, and that proposed subsection (a) supersedes 1 Pa. Code § 31.14 (relating to effective dates of agency orders).

§ 1230a.26. Representation

 This proposed section mirrors the current § 1230.26 (relating to representation). This proposed section provides that, except for an individual appearing on his own behalf, a party, corporation or group of individuals acting in concert must be represented by an attorney in good standing and outlines how that representation must be effected. This proposed section also provides that proposed subsections (a) through (d) supersede 1 Pa. Code §§ 31.21—31.23 (relating to appearance in person; appearance by attorney; and other representation prohibited at hearings).

§ 1230a.38. Commencement, form and content of Notice of Appeal

 This proposed section mirrors the current § 1230.38 (relating to commencement, form and content of notice of appeal). This proposed section details the proper form of, and procedure for filing, a Notice of Appeal. This proposed section also provides that proposed subsections (a) through (g) supersede 1 Pa. Code §§ 35.5—35.7 and 35.20 (relating to informal complaints; and appeals from actions of the staff).

§ 1230a.39. Timeliness of Notice of Appeal

 This proposed section amends the current § 1230.39 (relating to timeliness of Notice of Appeal), as detailed as follows. This proposed section provides that the timeliness of a Notice of Appeal is measured from the mailing date of the written notice of the action, and an untimely filed Notice of Appeal may be deemed an admission or be dismissed with prejudice. This proposed section further provides that the Department may file an answer and new matter to a Notice of Appeal within 30 days of service of the Notice, but is not required to do so.

 This proposed section proposes two amendments. First, proposed subsection (a) provides that the timeliness of an appeal will be measured from the mailing date of the written notice of the action instead of the date the appellant receives the written notice, as specified in the current subsection (a). This proposed amendment removes ambiguity relating to timeliness of appeals and removes the possibility for differing time periods for appeal. Second, proposed subsection (b) provides that an untimely filed Notice of Appeal may be deemed an admission or may be dismissed by the Department, instead of the language in the current § 1230.39 that one's ''failure to file'' a timely Notice of Appeal results in the same. This proposed amendment is a technical clarification. This proposed section also provides that proposed subsection (a) supersedes 1 Pa. Code §§ 35.5—35.7, 35.20 and 35.35 (relating to informal complaints; appeals from actions of the staff; and answers to complaints and petitions).

§ 1230a.43. Orders to Show Cause, orders or petitions filed by the Office

 This proposed section mirrors the current § 1230.43 (relating to Orders to Show Cause, orders or petitions filed by the Office), except for the revisions detailed as follows. This proposed section provides that the Office may start an action by filing an Order to Show Cause. Proposed subsection (b) revises the current subsection (b) to provide that the date of service is the date indicated on the certificate of service, regardless of the method of service, as opposed service being deemed complete 3 days after the date on the certificate of service if service is affected by mail. This proposed amendment eliminates ambiguity as to the date of service. This proposed section also specifies the required content for an Order to Show Cause and provides the required format for a notice to respond. Finally, this proposed section provides that proposed subsections (a) through (d) supersede 1 Pa. Code § 35.14 (relating to orders to show cause).

§ 1230a.44. Answers to Orders to Show Cause, orders or other petitions filed by the Office

 This proposed section mirrors the current § 1230.44 (relating to answers to orders to show cause, orders or other petitions filed by the Office), except for revising a citation to refer to this proposed chapter. This proposed section outlines the content, form, and substance of responses to Orders to Show Cause, orders or other petitions filed by the Office, in addition to providing penalties for failure to file a timely response. This proposed section also prohibits the filing of new matter or preliminary objections and specifies that proposed subsections (a) through (e) supersede 1 Pa. Code § 35.37 (relating to answers to orders to show cause).

§ 1230a.45. Verifications and affidavits

 This proposed section mirrors the current § 1230.45 (relating to verifications and affidavits). This proposed section provides that a pleading or other document containing an averment of fact not appearing of record in the action or containing a denial of fact shall be personally verified in a manner prescribed by this proposed section by a party thereto or by an authorized officer of the party if a corporation or other business entity.

§ 1230a.46. Entry of default judgment

 This proposed section mirrors the current § 1230.46 (relating to entry of default judgment). This proposed section provides that the Department, on motion of the Office, may enter default judgment against the respondent for failure to file within the required time an answer to an Order to Show Cause, order or other petition, to which the respondent may answer and have an opportunity to be heard; default judgment may not be granted prior to the hearing and the filing of an answer.

C. Affected Persons

 Medical marijuana applicants, patients and their caregivers, as well as grower/processor and dispensary permittees and approved labs, will be required to comply with the provisions in this proposed rulemaking. Additionally, those individuals or entities that have not yet been issued a permit to receive, dispense or prescribe medical marijuana as well as successful future applicants will be required to comply with the provisions contained in this proposed rulemaking.

D. Cost and Paperwork Estimate

Cost

Commonwealth

 The Department will experience increased demands to maintain compliance control over the Medical Marijuana Program. This increased demand will be handled by the existing Medical Marijuana Program complement. The Department does not expect that it will incur any cost increases as a result of this proposed rulemaking.

Local government

 This proposed rulemaking will impose no additional costs and have no negative fiscal impact upon political subdivisions. Further, this proposed rulemaking does not impose any additional burden of enforcement or review on political subdivisions.

Regulated community

 This proposed rulemaking will impose no additional costs upon medical marijuana cardholders and caregivers.

 Grower/processor and dispensary permittees may experience minimal cost increases in complying with the revised policies regarding facility security and testing and reporting requirements imposed by this proposed rulemaking.

 Practitioners will not experience any additional costs as a result of this proposed rulemaking.

General public

 This proposed rulemaking will have no fiscal impact on the general public.

Paperwork Estimates

Commonwealth and the regulated community

 This proposed rulemaking imposes no additional paperwork requirements on the Commonwealth or the regulated community.

Local government

 This proposed rulemaking imposes no additional paperwork requirements on local government.

General public

 This proposed rulemaking imposes no additional paperwork requirements on the general public.

E. Statutory Authority

 The Department obtains its authority to promulgate regulations relating to the Medical Marijuana Program from the provisions of the act. Section 301(a)(3) and (b) of the act (35 P.S. § 10231.301(a)(3) and (b)) provides the Department with the authority to promulgate all regulations necessary to carry out the provisions set forth in the act. Further, under section 301 of the act, the Department has (1) regulatory and enforcement authority over the growing, processing, sale and use of medical marijuana in this Commonwealth, and (2) authority to promulgate all regulations necessary to carry out the provisions of the act.

F. Effectiveness and Sunset Dates

 This proposed rulemaking becomes effective upon final-form publication in the Pennsylvania Bulletin. No sunset date will be established. The Department will continually review and monitor the effectiveness of these regulations after they are published as final.

G. Regulatory Review

 Under section 5(a) of the Regulatory Review Act, the act of June 30, 1989 (P.L. 73, No. 19) (71 P.S. § 745.5(a)), on February 16, 2020, the Department submitted a copy of these proposed regulations to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committee. In addition to submitting the proposed regulations, the Department has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form prepared by the Department. A copy of this form is available to the public upon request.

 Under section 5(g) of the Regulatory Review Act (71 P.S. § 745.5(g)), IRRC may convey any comments, recommendations, or objections to the proposed regulations within 30 days of the close of the public comment period. The comments, recommendations, or objections shall specify the regulatory review criteria that have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the regulation, by the Department, the General Assembly, and the Governor of comments, recommendation, or objections raised.

H. Contact Person

 Interested persons are invited to submit written comments, suggestions or objections regarding this proposed rulemaking to John J. Collins, Director, Office of Medical Marijuana, Department of Health, Room 628, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120, (717) 547-3047, or by e-mail to RA-DHMMregulations@pa.gov within 30 days after publication of these proposed regulations in the Pennsylvania Bulletin. Persons with a disability who wish to submit comments, suggestions, or objections regarding the proposed regulations may do so by using the previously listed number or address. Speech or hearing-impaired persons, or both, may submit comments, suggestions or objections by calling the Pennsylvania AT&T Relay Service at (800) 654-5984 (TDD users) or (800) 654-5988 (voice users).

ALISON BEAM, 
Acting Secretary

 Fiscal Note: 10-219. No fiscal impact; (8) recommends adoption.

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