Title 10
MARYLAND DEPARTMENT OF HEALTH

Subtitle 27 BOARD OF NURSING

10.27.01 Examination and Licensure

Authority: Health Occupations Article, §§1-205, 1-209, 1-213, 8-201, 8-205, 8-206, 8-301—8-315, 8-6A-05(a), 8-701, 8-7A-01, and 8-703; Tax-General Article, §§10-738 and 10-739(b)(1); Annotated Code of Maryland; Ch. 486, Acts of 2012; Chs. 281 and 282, Acts of 2013; Chs. 385 and 386, Acts of 2016; and Chs. 234 and 234, Acts of 2017

Notice of Final Action

[25-008-F]

On April 24, 2025, the Secretary of Health adopted amendments to Regulation .02 under COMAR 10.27.01 Examination and Licensure. .This action, which was proposed for adoption in 52:5 Md. R. 244—245 (March 7, 2025), has been adopted as proposed.

Effective Date: July 1, 2025.

MEENA SESHAMANI, M.D., PhD
Secretary of Health

Title 11
DEPARTMENT OF TRANSPORTATION

Subtitle 15 MOTOR VEHICLE ADMINISTRATION—VEHICLE REGISTRATION

11.15.40 Plug-In Electric Drive Vehicles

Authority: Transportation Article §§12-104(b), 11-103.4, [and] 13-815, and 13-956, Annotated Code of Maryland

Notice of Final Action

[24-232-F]

On May 7, 2025, the Administrator of the Motor Vehicle Administration adopted amendments to Regulations .01, .03, and .04 and new regulation .05 under COMAR 11.15.40—Plug-in Electric [Vehicle] Drive Vehicles [and Low Emission Vehicle Excise Tax Credit]. This action, which was proposed for adoption in 52:6 Md. R. 287 (March 21, 2025), has been adopted as proposed.

Effective Date: May 26, 2025.

CHRISTINE NIZER

Administrator

Title 14
INDEPENDENT AGENCIES

Subtitle 17 MARYLAND CANNABIS ADMINISTRATION

Notice of Final Action

[24-226-F]

On April 23, 2025, the Maryland Cannabis Administration adopted:

(1) Amendments to Regulations .03 and .04 and new Regulation .11 under COMAR 14.17.06 Standard Cannabis Licenses;

(2) New Regulation .09 under COMAR 14.17.07 Micro Cannabis Licenses;

(3) Amendments to Regulation .09 under COMAR 14.17.10 Cannabis Grower Operations;

(4) Amendments to Regulation .19 under COMAR 14.17.11 Cannabis Processor Operations;

(5) Amendments to Regulation .06 under COMAR 14.17.12 Cannabis Dispensary Operations;

(6) Amendments to Regulations .01—.06 under COMAR 14.17.17 Receivership; and

(7) Amendments to Regulation .02 under COMAR 14.17.21 Fees.

This action, which was proposed for adoption in 52:2 Md. R. 122—125 (January 24, 2025), has been adopted with the nonsubstantive changes shown below.

Effective Date: May 26, 2025.

Attorney General’s Certification

In accordance with State Government Article, §10-113, Annotated Code of Maryland, the Attorney General certifies that the following changes do not differ substantively from the proposed text. The nature of the changes and the basis for this conclusion are as follows:

COMAR 14.17.06.03F: To resolve a conflict between proposed text in §E and §F(2), the MCA is clarifying that the permission in §E for growers and processors to change location outside of the region in which they were awarded a license if the change is due to a co-location agreement is an exception to the provision in §F(2).

COMAR 14.17.06.04J: MCA is clarifying that a unit of ownership in a licensee’s subsidiary issued as an employee incentive unit would be subject to the provisions of this section. Additionally, MCA is streamlining terms throughout the section by using the term individual to describe someone who may receive an incentive unit under this section. MCA is also clarifying that employee incentive units issued to employees must be disclosed on the licensee’s annual ownership report. Finally, MCA is correcting references and numbering errors.

COMAR 14.17.06.11C: To ensure co-location provisions align with the intent for growers and processors to be distributed proportionately throughout the State, MCA is clarifying that at least one co-locating licensee is operating in the region they were awarded a license.

COMAR 14.17.06.11E: To ensure each co-locating licensee has unfettered access to its video surveillance recordings, MCA is clarifying that a co-located licensee shall have equal access to its video surveillance recordings and equal control over access to its storage areas.

COMAR 14.17.06.11F: MCA is clarifying that a co-location agreement may not take effect without its approval of agreement terms and that co-locating licensees who are sharing security or video surveillance systems must specify which licensee is responsible for ensuring the shared systems comply with the applicable regulations.

COMAR 14.17.06.11G: MCA is clarifying the actions it may take if it determines a co-location agreement violates the regulation; rather than invalidate the agreement, MCA would deny or rescind approval of it.

COMAR 14.17.12.06B: MCA is correcting conjunctions in this section to align with the relevant statutory provision, Alcoholic Beverages and Cannabis Article, §36-410(a)(3), Annotated Code of Maryland.

COMAR 14.17.17.01B: MCA is removing redundant language and clarifying provisions to better articulate its intent.

COMAR 14.17.17.03: MCA is specifying that the term “order” in this regulation refers to a court order.

COMAR 14.17.17.04B: Throughout this section MCA is making terms consistent with §F of this regulation by clarifying that the plan for disposition of the license and the cannabis inventory are subject to the provisions of this chapter.

COMAR 14.17.17.04G: Consistent with §B(7) of this regulation, which establishes that all disposition plans are subject to MCA approval, MCA is clarifying that any plan modification is subject to MCA approval as well.

COMAR 14.17.17.06: As proposed, §§D and E prohibit any individual or entity with a security interest in a cannabis business from bidding or ultimately buying the license being disposed. MCA is further specifying that this prohibition includes any creditor subsidiaries or affiliates as well.

14.17.06 Standard Cannabis Licenses

Authority: Alcoholic Beverages and Cannabis Article, §§36-201, 36-401, and 36-403, Annotated Code of Maryland

.03 Change of Location.

A.—D. (proposed text unchanged)

E. (proposed text unchanged)

F. The Administration may deny a change of location application if:

(1) (proposed text unchanged)

(2) [[The]] Notwithstanding §E of this regulation, the change of location would move the proposed licensed location outside of the region or jurisdiction in which it was awarded; or

(3) (proposed text unchanged)

G. (proposed text unchanged)

.04 Transfer of Ownership Interest in a License.

A.—I. (proposed text unchanged)

J. Employee Incentive Programs.

(1) In this section, the term “incentive unit” means a unit of ownership in the licensee or its parent, subsidiary, or affiliate such as stock or limited liability company membership, issued to an [[employee of the licensee]] individual as part of [[an]] a licensee’s employee incentive program or other compensation.

[[(1)]] (2) (proposed text unchanged)

[[(2)]] (3) A licensee shall:

(a) Establish a detailed employee incentive plan for each [[agent, employee, or owner]] individual to whom it intends to issue incentive units and issue incentive units in accordance with the plan; and

(b) Upon request, provide a copy of the plan in [[§J(2)(a)]] §J(3)(a) of this regulation, in a manner prescribed by the Administration.

[[(3)]] (4) —[[(4)]](5)(proposed text unchanged)

[[(5)]] (6) In the annual disclosure of ownership and control report required by COMAR 14.17.16.02, a licensee shall [[include]] disclose any employee [[ownership transfers]] incentive unit issuances or transfers that have occurred since the date of the licensee's last annual disclosure submission.

.11 Licensee Co-Location.

A.—B. (proposed text unchanged)

C. Two or more grower or processor licensees may enter an agreement to share a licensed premises, provided at least one of the licensees operates in the region in which they were awarded a license.

D. (proposed text unchanged)

E. A co-located licensee shall:

(1)—(3) (proposed text unchanged)

(4) [[Independently and uniquely]] Have equal, independent, and unique control over access to its storage area, including the ability to add or remove its badged agents to access any area in which their plants or products are stored;

(5) Have equal, independent, and unique access to its video surveillance recordings, which shall be recorded and saved as required by COMAR 14.17.10.02 or COMAR 14.17.11.02, whichever applies; and

(6) (proposed text unchanged)

F. A co-location agreement [[may not]]:

(1) [[Transfer]] May not transfer ownership or control of a license in violation of Alcoholic Beverages and Cannabis Article, §36-503, Annotated Code of Maryland;

(2) [[Be]] May not be used to circumvent any requirements for operating a licensed premises; [[or]]

(3) [[Take]] May not take effect prior to [[inspection of the shared premises by the]] Administration[[.]]:

(a) Approval of the agreement terms; and

(b) Inspection of the shared premises; and

(4) If co-located licensees are sharing security or video surveillance systems, shall specify which licensee is responsible for ensuring a shared system complies with COMAR 14.17.10.02F and G or COMAR 14.17.11.02E and F, whichever apply.

G. (proposed text unchanged)

H. If the Administration determines a co-location agreement violates §F of this regulation, the Administration may:

(1) [[Invalidate]] Deny or rescind approval of the co-location agreement; and

(2) (proposed text unchanged)

14.17.12 Cannabis Dispensary Operations

Authority: Alcoholic Beverages and Cannabis Article, §§36-202, 36-203, 36-401, and 36-410, Annotated Code of Maryland

.06 Product Reservations and Trade Practices.

A. (proposed text unchanged)

B. Subject to §§C and D of this regulation, a dispensary licensed under COMAR 14.17.06.08 or COMAR 14.17.07.07 shall ensure at least 25 percent of product available for retail sales are products grown, manufactured, extracted, or otherwise produced by:

(1) Licensees that have no common ownership interest or control with the dispensary licensee; [[or]] and

(2) (proposed text unchanged)

C.—F. (proposed text unchanged)

14.17.17 Receivership

Authority: Alcoholic Beverages and Cannabis Article, §§36-202, 36-203, and 36-503, Annotated Code of Maryland

.01 Security Interest in a Cannabis License.

A. (proposed text unchanged)

B. A security agreement may not contain provisions that authorize the creditor to:

(1) [[Unilaterally:[AB1]

(a)]] Require the security agreement to become due earlier than the terms specified in the agreement, except if the licensee materially breaches or defaults on its material obligations as set forth in the security agreement;

[[(b)]] (2) Convert the debt under the security agreement to equity whether present, optional, or future, in a manner that violates Maryland law concerning ownership and control of a license, including restrictions on transfers of a license; [[or]]

[[(c)]] (3) (proposed text unchanged)

[[(2)]] (4)—[[(3)]] (5) (proposed text unchanged)

C.—D. (proposed text unchanged)

.03 Selection of an Eligible Receiver.

A. A creditor may select an eligible receiver who is registered with the Administration to oversee the disposition of a cannabis license if the licensee is the subject of [[an]] a court order requiring appointment of a receiver.

B. Within 10 business days of a court order requiring appointment of a receiver, the creditor shall submit to the Administration:

(1) (proposed text unchanged)

(2) Proof of [[an]] a court order requiring appointment of a receiver; and

(3) (proposed text unchanged)

.04 Receivership Registration.

A.(proposed text unchanged)

B. The prospective receiver shall submit to the Administration a completed registration form, in a manner specified by the Administration, accompanied by the following:

(1) Documentation establishing the [[applicant’s]] prospective receiver’s qualifications and ability to oversee the orderly disposition of the secured license and the licensee’s cannabis inventory, in a manner that facilitates continuity of the licensee’s operations to the extent possible, including demonstrated understanding of the laws and regulations that apply to:

(a)—(b) (proposed text unchanged)

(2)—(6) (proposed text unchanged)

(7) A disposition of license plan, subject to Administration approval, which includes:

(a) A detailed description of the plan for the orderly disposition of the license and [[associated business assets]] the licensee’s cannabis inventory, to satisfy the security interest in the right to the proceeds from the sale of the license; and

(b) A proposed timeline for the orderly disposition of the license of the associated licensee and the licensee’s cannabis inventory; and

(8) (proposed text unchanged)

C. (proposed text unchanged)

D.—F. (proposed text unchanged)

G. The receiver [[shall report]] may not implement any disposition of license plan modifications [[submitted as part of the registration within 10 days of the plan modification to the Administration]] prior to receiving Administration approval of the plan modifications.

.06 Disposition of a Cannabis License.

A.—C. (proposed text unchanged)

D. An individual [[or]], entity, or an entity’s parent company, subsidiary, or affiliate, may not bid on or obtain a cannabis license that is subject to disposition under this chapter if it has any security interest in the cannabis license.

E. The Administration shall deny the transfer and sale of any cannabis license to an individual or entity, or an entity’s parent company, subsidiary, or affiliate, if it has any security interest in the cannabis license.

F.— J. (proposed text unchanged)

TABATHA ROBINSON
Director

Subtitle 22 COMMISSION ON CRIMINAL SENTENCING POLICY

Notice of Final Action

[25-021-F]

On May 6, 2025, the Maryland State Commission on Criminal Sentencing Policy adopted:

(1) Amendments to Regulation .05 under COMAR 14.22.01 General Regulations; and

(2) Amendments to Regulation .02 under COMAR 14.22.02 Criminal Offenses and Seriousness Categories.

This action, which was proposed for adoption in 52:6 Md. R. 288—289 (March 21, 2025), has been adopted as proposed.

Effective Date: July 1, 2025.

DAVID A SOULE
Executive Director

Title 20
PUBLIC SERVICE COMMISSION

Subtitle 53 COMPETITIVE ELECTRICITY SUPPLY

20.53.07 Residential Customer Protection

Authority: Public Utilities Article, §§2-113, 2-121, 4-308, 5-101, 7-505, 7-507, 7-511, [[and]] 7-603, and 7-707, Annotated Code of Maryland

Notice of Final Action

[25-001-F]

On April 23, 2025, the Public Service Commission adopted amendments to Regulation .07 and new Regulation .15 under COMAR 20.53.07 Residential Customer Protection. This action, which was proposed for adoption in 52:5 Md. R. 246—247 (March 7, 2025), has been adopted with the nonsubstantive changes shown below.

Effective Date: May 26, 2025.

Attorney General’s Certification

Public Utilities Article, §7-707, Annotated Code of Maryland was added to the authority line.

ANDREW S. JOHNSTON
Executive Secretary

Subtitle 59 COMPETITIVE GAS SUPPLY

20.59.07 Residential Customer Protection

Authority: Public Utilities Article, §§2-113, 2-121, 4-308, 5-101, 7-507, 7-511, and 7-601—7-606, Annotated Code of Maryland

Notice of Final Action

[25-002-F]

On April 23, 2025, the Public Service Commission adopted amendments to Regulation .07 under COMAR 20.59.07 Residential Customer Protection. This action, which was proposed for adoption in 52:5 Md. R. 247 (March 7, 2025), has been adopted as proposed.

Effective Date: May 26, 2025.

ANDREW S. JOHNSTON

Executive Secretary

Subtitle 61 RENEWABLE ENERGY PORTFOLIO STANDARD PROGRAM

Notice of Final Action

[25-003-F]

On April 23, 2025, the Public Service Commission adopted:

(1) New Regulation .07 under COMAR 20.61.01 General; and

(2) Amendments to Regulations .01 and .02 under COMAR 20.61.04 Consumer Protection, Reporting, and Enforcement.

This action, which was proposed for adoption in 52:5 Md. R. 248 (March 7, 2025), has been adopted as proposed.

Effective Date: May 26, 2025.

ANDREW S. JOHNSTON
Executive Secretary

Title 36
MARYLAND STATE LOTTERY AND GAMING CONTROL AGENCY

Notice of Final Action

[24-156-F]

On April 24, 2025, the Maryland Lottery and Gaming Control Agency adopted:

(1) Amendments to Regulations .01—.06 under COMAR 36.01.01 General;

(2) Amendments to Regulations .01—.06, and .08 under COMAR 36.01.03 Voluntary Exclusion and Responsible Gaming;

(3) Amendments to Regulation .01 and new Regulation .02 under COMAR 36.02.01 General ;

(4) Amendments to Regulations .01—.10 under COMAR 36.02.02 Retailer Licensing;

(5) Amendments to Regulation .01, new Regulations .02—.05, the amendment and recodification of existing Regulations .02—.11 to be Regulations .06—.15, and the repeal of existing Regulation .12 under COMAR 36.02.03 Retailer Requirements;

(6) Amendments to Regulations .01—.07 and the repeal of existing Regulation .08 under COMAR 36.02.04 Common Provisions for All Lottery Games;

(7) Amendments to Regulations .01—.04 under COMAR 36.02.05 Specific Game Provisions;

(8) Amendments to Regulations .01 and .02 under COMAR 36.02.07 Unclaimed Lottery Prizes; and

(9) Amendments to Regulations .01—.05 under COMAR 36.02.09 Instant Ticket Lottery Machines.

This action, which was proposed for adoption in 51:24 Md. R. 1099—1119 (December 2, 2024), has been adopted as proposed.

Effective Date: May 26, 2025.

JOHN MARTIN
Director

Withdrawal of Regulations

Title 36
MARYLAND STATE LOTTERY AND GAMING CONTROL AGENCY

Notice of Withdrawal

[24-169-W]

The Maryland Lottery and Gaming Control Agency withdraws proposed amendments to:

(1) Regulation .36 under COMAR 36.03.10 Video Lottery Facility Minimum Internal Control Standards; and

(2) Regulation .15 under COMAR 36.05.03 Table Game Procedures,

as published in 51:23 Md. R.1117—1120 (December 2, 2024).

JOHN MARTIN
Director

Proposed Action on Regulations

Title 09
MARYLAND DEPARTMENT OF LABOR

Subtitle 34 OFFICE OF CEMETERY OVERSIGHT

Authority: Business Regulation Article, §§5-102, 5-204, 5-205, 5-301-312, 5-401-403, 5-901-5-905; Health-General Article, §5-508, Annotated Code of Maryland

Notice of Proposed Action

[25-078-P]

The Office of Cemetery Oversight proposes to:

(1) Amend Regulation .02 under COMAR 09.34.05 Crematories—Definitions;

(2) Amend Regulations .02—.07, and 14 under COMAR 09.34.06 Crematories—Permit and Registration Process and Fees;

(3) Amend Regulation .02 under COMAR 09.34.07 Crematories—Inspections, Complaints, and Discipline;

(4) Amend Regulations .01—.03, .05—.08, and .10—.12 under COMAR 09.34.08 Crematories—Crematory Procedures; and

(5) Amend Regulation .02 under COMAR 09.34.09 Crematories—Code of Ethics.

This action was considered at the March 27, 2025 Office of Cemetery Oversight Advisory Council On Cemetery Operations public meeting.

Statement of Purpose

The purpose of this action is to expand the options available for Marylanders for the final disposition of human remains by regulating alkaline hydrolysis in order to protect the dignity and needs of those who choose alkaline hydrolysis and to incorporate its oversight of the process of alkaline hydrolysis as well as the operation of the appliances and facilities for alkaline hydrolysis.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Deborah Rappazzo, Director of the Office of Cemetery Oversight, Maryland Department of Labor, Maryland Department of Labor, 100 S. Charles St., Twr 1 Baltimore MD 21201, or call 410-230-6228, or email to deborah.rappazzo@maryland.gov. Comments will be accepted through June 16, 2025. A public hearing will be held on June 26, 2025 at 9:30a.m at Maryland Department of Labor, 100 S. Charles St., Baltimore, MD 21201

To access the meeting virtually: https://meet.google.com/qbi-saua-preTo access the meeting by dialing in from a phone: ‪(US) ‪+1 661-432-1294 PIN: 461 303 003#

Open Meeting

Final action on the proposal will be considered by the Office of Cemetery Oversight during a public meeting to be held on June 26, 2025 at 9:30am. To access the meeting virtually: https://meet.google.com/qbi-saua-pre
To access the meeting by dialing in from a phone: ‪(US) ‪+1 661-432-1294 PIN: 461 303 003#.

09.34.05 Crematories — Definitions

Authority: Business Regulation Article, §5-204[,] ; Health-General Article, §5-508, Annotated Code of Maryland

.02 Definitions.

A. (text unchanged)

B. Terms Defined.

(1) (text unchanged)

(2) “Alkaline hydrolysis” means the process of reducing human remains using water, alkaline chemicals, and heat inside a watertight vessel to accelerate decomposition.

[(2)] (3) “Authorizing agent” means an individual [legally entitled to order the cremation of human remains or legally authorized to control] who has legal authority to arrange for and make decisions regarding the final disposition of human remains, including cremation or alkaline hydrolysis.

[(3)] (4) Consumer.

(a)—(b) (text unchanged)

(c) “Consumer” includes a funeral establishment contracting with a crematory or the designated next of kin of a decedent contracting with a crematory.

[(5)] (6) (text unchanged)

[(6)] (7) “Cremation” means [the process of reducing human remains to bone fragments through intense heat and evaporation, including any mechanical or thermal process and may include pulverization.] disposition of a dead human body by means of incineration.

[(7)] (8)—[(8)] (9) (text unchanged)

[(9)] (10) “Crematory” means a building, portion or a building, or structure that houses the necessary appliances and facilities for cremation, alkaline hydrolysis, or both.

[(10)] (11) (text unchanged)

(12) “Decedent” means a dead human being.

[(11)] (13)— [(12)] (14) (text unchanged)

[(13)] (15) “Holding facility" means an area, within or adjacent to a crematory, designed for the retention of human remains before cremation or alkaline hydrolysis.

[(14)] (16) Human Remains.

(a) “Human remains” means:

(i) [the] The body of a deceased person[,]; or

(ii) A part of a body or limb that has been removed from a living person.

(b) “Human remains” includes the body or part of a body or limb in any state of decomposition.

(17) “Hydrolysis container” means a container, other than a casket, designed to enclose human remains and made of suitable material to be easily destroyed during hydrolysis that resists spillage and leakage.

(18) “Hydrolysis unit” means the watertight vessel in which the process of alkaline hydrolysis occurs.

(19) “Hydrolyzed human remains” means the recoverable bone fragments of a deceased person that result from the completion of alkaline hydrolysis.

[(15)] (20)—[(18)] (23) (text unchanged)

[(19)] (24) “Processed human remains" means the end result of pulverization [of cremated human remains], where the residue from the cremation or alkaline hydrolysis process is [cleaned] pulverized, leaving only bone fragments reduced to 5 millimeters or less.

[(20)] (25)—[(22)] (27) (text unchanged)

09.34.06 Crematories — Permit and Registration Process and Fees

Authority: Business Regulation Article, §§5-102, 5-204, 5-205, 5-301—5-310, 5-312, 5-401—5-403, and 5-901—5-905, Annotated Code of Maryland

.02 Permit Issuing Agency.

A.—C. (text unchanged)

D. A person who is a licensee or holder of a corporation license under Health Occupations Article, Title 7, Annotated Code of Maryland, and owns a greater interest in a crematory than a person who holds a permit or registration under Business Regulation Article, Title [7] 5, Annotated Code of Maryland, shall obtain a permit to engage in the operation of a crematory from the Board.

E. (text unchanged)

F. All operating crematories and individuals designated as the registered crematory operator required to obtain a permit from the Office shall apply to the Office for a permit [within 90 days from the effective date of this chapter].

G. A permit issued by the Office shall specify if the crematory is authorized to offer and perform either cremation services, alkaline hydrolysis services, or both.

.03 Permit — Requirements for Permit for a Crematory Owned by a Corporation, Limited Liability Company, or Partnership.

A. (text unchanged)

B. A corporation, limited liability company, or partnership shall receive a permit if the entity:

(1)—(3) (text unchanged)

(4) Designates a registered crematory operator as the responsible party for each affiliated crematory provided that:

(a) [the] The registered crematory operator may not be designated as the responsible party for more than a total of two crematories; and

(b) A registered crematory operator shall be registered to operate a cremator, an alkaline hydrolysis unit, or both;

(5)—(7) (text unchanged)

.04 Permit — Requirements for Permit for a Crematory Owned by a Sole Proprietor.

A. (text unchanged)

B. A sole proprietor shall receive a permit if the sole proprietor:

(1)—(3) (text unchanged)

(4) Designates a registered crematory operator as the responsible party for each affiliated crematory provided that:

(a) [the] The registered crematory operator may not be designated as the responsible party for more than a total of two crematories; and

(b) A registered crematory operator shall be registered to operate a cremator, alkaline hydrolysis unit, or both;

(5)—(6) (text unchanged)

.05 Permit — Requirements for Registration for a Registered Crematory Operator.

A. An individual shall register with and receive a permit from the Office as a registered crematory operator if the individual meets the registration requirements of this regulation and the permit shall specify whether the individual’s training and registration required by this chapter permits the individual to operate a cremator, alkaline hydrolysis unit, or both.

B. An individual shall be registered with the Office as a registered crematory operator if the individual:

(1)—(4) (text unchanged)

(5) Has achieved certification as a crematory operator by the Cremation Association of North America [(CANA)], International Cemetery, Cremation and Funeral Association [(ICCFA)], or other equivalent certification recognized by the Office and the Board;

(6) Has successfully completed the operator training course of the manufacturer of the cremator or alkaline hydrolysis unit located in the crematory with which the applicant is affiliated;

(7)—(10) (text unchanged)

C.—E. (text unchanged)

[F. An individual who will become the registered crematory operator for a crematory which was in operation prior to the effective date of this chapter or for a crematory which has filed an application for a permit pursuant to this chapter shall obtain the certification and training required by §B(5) and (6) of this regulation within 90 days from the effective date of this chapter or be subject to action by the Office.]

.06 Permit — Requirements for Permit for a New Crematory Owned by a Corporation, Limited Liability Company, or Partnership.

A. (text unchanged)

B. A corporation, limited liability company, or partnership shall receive a permit from the Office if, at least 30 days prior to the opening of the new crematory, the entity:

(1)—(3) (text unchanged)

(4) Designates a registered crematory operator as the responsible party for each affiliated crematory provided that:

(a) [the] The registered crematory operator may not be designated as the responsible party for more than a total of two crematories; and

(b) A registered crematory operator shall be registered to operate a cremator, alkaline hydrolysis unit, or both.

(5)—(6) (text unchanged)

C. Crematories [not in operation prior to the effective date of this chapter] shall be certified by:

(1) The Cremation Association of North America [(CANA)];

(2) The International Cemetery, Cremation and Funeral Association [(ICCFA)]; or

(3) (text unchanged)

.07 Permit — Requirements for a New Crematory Owned by a Sole Proprietor.

A. (text unchanged)

B. A sole proprietor shall receive a permit from the Office if, at least 30 days prior to the opening of the new crematory, the sole proprietor applicant:

(1)—(3) (text unchanged)

(4) Designates a registered crematory operator as the responsible party for each affiliated crematory provided that:

(a) [the] The registered crematory operator may not be designated as the responsible party for more than a total of two crematories; and

(b) A registered crematory operator shall be registered to operate a cremator, alkaline hydrolysis unit, or both.

(5)—(6) (text unchanged)

C. Before applying to the Office for a permit, [any] a crematory [not in operation before the effective date of this chapter,] shall have in its employ an individual who holds a certification from:

(1) The Cremation Association of North America [(CANA)];

(2) The International Cemetery, Cremation and Funeral Association [(ICCFA)]; or

(3) Another equivalent body recognized by the Office and the Board.

.14 Cremation Prior to Obtaining a Permit.

A crematory may cremate or hydrolyze the human remains of one decedent prior to obtaining a permit from the Office, provided:

A. The cremation or alkaline hydrolysis is only performed as part of the manufacturer’s operator training course for the cremation machinery or alkaline hydrolysis unit in which the cremation or alkaline hydrolysis takes place; and

B. The person or persons with the right to final disposition of the decedent are notified and have given permission prior to the cremation or alkaline hydrolysis.

09.34.07 Crematories — Inspections, Complaints, and Discipline

Authority: Business Regulation Article, §§5-204, 5-310, and 5-311, Annotated Code of Maryland

.02 Inspection by the Office.

A.—B. (text unchanged)

C. A crematory shall maintain the following minimum standards:

(1) (text unchanged)

(2) Except by express, written consent of the authorizing agents to perform simultaneous, multiple cremations or alkaline hydrolyzations, there shall be no more than one human body [cremated] processed in a single cremator or alkaline hydrolysis unit at a time;

(3) A cremator or alkaline hydrolysis unit shall be cleaned completely after each cremation or alkaline hydrolysis;

(4) There may not be co-mingling of human remains and pet remains in refrigeration units, [or cremation machinery] cremators, or alkaline hydrolysis units;

(5) Separate cremators or alkaline hydrolysis units shall be dedicated for the cremation or alkaline hydrolysis of human remains and the cremation or alkaline hydrolysis of pets;

(6) There may not be:

(a) Co-mingling of [cremated] processed human remains with other [cremated] processed human remains or pet remains;

(b) Scooping of [cremated] processed human remains from a bucket containing commingled [cremated] processed human remains; or

(7) Excluding a deceased person with a known communicable infection, human remains shall be properly identified before cremation or alkaline hydrolysis by verifying that the documentation accompanying the human remains is consistent with a visual observation of the human remains;

(8) (text unchanged)

(9) Each crematory shall have:

(a) A sink with hot and cold water in the room in which the [cremator] crematory equipment is housed; and

(b) The [equipment] tools necessary to thoroughly clean the floor within the room housing the [cremator] crematory equipment with water and an appropriate sanitizing agent;

(10) The name of the deceased shall be visible on the outside of the [cremation] crematory container;

(11) Human remains shall be properly stored prior to cremation or alkaline hydrolysis;

(12) Crematories shall:

(a) (text unchanged)

(b) Pulverize the [cremated] processed human remains with a mortar and pestle when the [cremated] processed human remains are not sufficient in amount for pulverizing in mechanical equipment;

(13) Separate pulverizing drums shall be dedicated for [cremated] processed human remains and [cremated] processed pet remains;

(14) (text unchanged)

(15) A crematory may not refuse to release [cremated] processed human remains pending payment of outstanding fees;

(16) [Within 6 months of the effective date of this regulation, cremators] Cremators without safety devices that prevent the automatic door from dropping prematurely shall be retrofitted with such safety devices;

(17)—(20) (text unchanged)

(21) All individuals who operate the cremator or alkaline hydrolysis unit in a crematory shall be certified by the Cremation Association of North America [(CANA)], International Cemetery, Cremation and Funeral Association [(ICCFA)], or other equivalent certification recognized by the Office and the Board. Individuals receiving training toward certification to operate a cremator or alkaline hydrolysis unit shall be allowed to work under the supervision of a registered crematory operator who has the required certification for a period not to exceed 6 months.

D. The following completed forms shall be available at all times for inspection and copying and are subject to be pulled at random by the inspector:

(1) [Cremation] Crematory services authorization form;

(2)—(4) (text unchanged)

(5) Record of cremation or alkaline hydrolysis;

(6) Certificate of cremation or alkaline hydrolysis; and

(7) Return of human [cremated] processed remains certificate.

E.—G. (text unchanged)

H. At the time of the Office’s inspection, the permit holder shall provide written documentation to the Office’s inspector that:

(1) The [cremator] crematory equipment has been inspected in accordance with manufacturer specifications;

(2) (text unchanged)

(3) The permit holder has requested that the manufacturer conduct an inspection of the [cremator] crematory equipment.

09.34.08 Crematories — [Cremation] Crematory Procedures

Authority: Business Regulation Article, §5-204, Annotated Code of Maryland

.01 Scope.

This chapter governs the procedures to be followed by a permit holder in performing a cremation or alkaline hydrolysis in this State.

.02 Removal, Identification, and Transportation of Human Remains.

A. Upon receipt of human remains, a permit holder, in the presence of the authorizing agent or representative of the funeral establishment engaging crematory services, shall:

(1)—(2) (text unchanged)

(3) Refuse to accept human remains for cremation or alkaline hydrolysis if an inspection of the human remains indicates the presence of any battery operated, implanted device;

(4) Remove and properly dispose of any hazardous object or any other materials that the permitted designee of the crematory authority deems should be removed from the human remains or [cremation] crematory container in order to prevent harm to the public health or damage to the cremator or alkaline hydrolysis unit;

(5) Remove any jewelry on the human remains or in the [cremation] crematory container;

(6) Return any removed jewelry to the authorizing agent or representative of the funeral establishment engaging [cremation] crematory services; and

(7) Obtain a signed, itemized receipt from the authorizing agent or representative of the funeral establishment engaging [cremation] crematory services for the removed jewelry and retain the receipt as a permanent record.

B.—C. (text unchanged)

D. A crematory authority shall not accept unidentified human remains for cremation or alkaline hydrolysis.

.03 [Cremation Container] Crematory Containers.

A. A cremation container:

(1)—(5) (text unchanged)

(6) Shall comply with all local, State, and federal governmental emissions regulations; [and]

(7) May not be composed of metal or polyethylene material; and

(8) A cremation container which appears to be heavily coated with varnish, lacquer, or any other highly combustible substance shall be:

(a) Placed in a cold cremator within which no cremation has occurred in the prior 4 hours; or

(b) Coated completely with water before being placed in the cremator.

B. [A cremation container which appears to be heavily coated with varnish, lacquer, or any other highly combustible substance shall be:] An alkaline hydrolysis container:

(1) [Placed in a cold cremator within which no cremation has occurred in the prior 4 hours; or] Shall consist of a completely enclosed biodegradable covering for the human remains;

(2) [Coated completely with water before being placed in the cremator.] Once inside the alkaline hydrolysis unit, may be removed;

(3) Shall be resistant to leakage or spillage;

(4) Shall provide protection to the health and safety of crematory establishment personnel and the public;

(5) Shall comply with all local, State, and federal governmental emissions regulations; and

(6) May not be composed of metal or polyethylene material.

.05 Holding Remains.

A. Unless prevented by emergency circumstances, human remains that have been designated for cremation or alkaline hydrolysis shall be [cremated] processed by a crematory authority within 48 hours after receipt.

B. A crematory authority may not hold human remains for cremation or alkaline hydrolysis unless the human remains are contained within an individual, [rigid, stackable,] closed cremation or alkaline hydrolysis container as required under Regulation .03 of this chapter.

C. A crematory authority may not accept a cremation or alkaline hydrolysis container from which there is any evidence of leakage of the body fluids from the human remains therein.

D. Whenever a crematory authority is unable to cremate or hydrolyze human remains within 48 hours of taking custody thereof due to emergency circumstances, the crematory authority shall maintain the human remains in a refrigerated holding facility, either on or off site, at 40° F or less, unless the remains have been embalmed.

.06 Identification of Human Remains Immediately Prior to Cremation or Alkaline Hydrolysis.

A. Immediately prior to being placed within the cremator or alkaline hydrolysis unit, a designee of the crematory authority shall:

(1) (text unchanged)

(2) Place in the cremator or alkaline hydrolysis unit the circular, hard metal identification disc of the human remains being [cremated] processed where it shall remain in place until the cremation or alkaline hydrolysis process is complete.

B. The designee of the crematory authority who is operating the cremator or alkaline hydrolysis unit may not leave the immediate area of the cremator or alkaline hydrolysis unit during the cremation or alkaline hydrolysis process.

.07 [Cremation] Crematory Services Authorization.

A. Except as otherwise provided in this regulation, a crematory authority may not cremate or hydrolyze human remains until:

(1) (text unchanged)

(2) The crematory has received:

(a) A cremation or alkaline hydrolysis authorization on a form approved by the Office and signed by an authorizing agent;

(b)—(c) (text unchanged)

(3) The crematory authority has documented that at least 12 hours have elapsed from the time of death of the individual whose remains are to be [cremated] processed.

B. The cremation or alkaline hydrolysis authorization form shall:

(1) (text unchanged)

(2) Contain the following information:

(a)—(b) (text unchanged)

(d) (text unchanged)

(e) Authorization for the crematory authority to cremate or hydrolyze the human remains;

(f) Authorization to verify that the following have been removed prior to cremation or alkaline hydrolysis:

(i)—(ii) (text unchanged)

(g) A representation by the authorizing agent that radiological implant treatment has not occurred to the human remains within 5 days before cremation or alkaline hydrolysis;

(h) A representation that the authorizing agent is aware of no objection to the human remains being [cremated] processed by any person who has a right to control the disposition of the human remains; and

(i) The name and address of the person authorized to claim the [cremated] processed remains from the crematory authority or accept the [cremated] processed remains via registered mail; and

(3) Be signed by the authorizing agent.

C. If an authorizing agent is not available to execute the [cremation] crematory services authorization form, the authorizing agent may delegate that authority to another individual:

(1)—(2) (text unchanged)

D. (text unchanged)

E. A person signing a [cremation] crematory services authorization form is deemed to warrant the truthfulness of any facts set forth in the [cremation] authorization form, including the identity of the deceased whose remains are sought to be [cremated] processed and the authority of that person to order such a cremation or alkaline hydrolysis.

F. A crematory authority shall notify and obtain the written consent of the authorizing agent before the cremation or alkaline hydrolysis of human remains at a location other than the location named on the cremation or alkaline hydrolysis authorization form.

G. A crematory authority shall maintain a copy of every [cremation] crematory services authorization form required under this regulation as permanent records.

H. [Cremation] Crematory services authorization records are subject to inspection and copying by the Office.

.08 Record of Receipt of Remains.

A. A crematory authority shall provide to an individual who delivers human remains for cremation or alkaline hydrolysis a receipt signed by both the crematory authority and the person who delivered the human remains, that includes the:

(1)—(6) (text unchanged)

B. The crematory authority shall maintain a record of each cremation or alkaline hydrolysis which shall include the:

(1)—(5) (text unchanged)

(6) Date, time, and location of cremation or alkaline hydrolysis; and

(7) Name of the individual who performed the cremation or alkaline hydrolysis.

C. The crematory authority shall provide a certificate of disposition of [cremated] processed human remains to the authorizing agent or funeral establishment that arranged for the cremation or alkaline hydrolysis that contains the:

(1)—(2) (text unchanged)

(3) Date, time, and location where cremation or alkaline hydrolysis occurred;

(4) Name of the individual who performed the cremation or alkaline hydrolysis;

(5) Name and address of the person who received the [cremated] processed human remains from the crematory authority; and

(6) If ascertainable, the location, including the name of the cemetery and plot location if the remains are interred, the manner, and the date of the disposition of the [cremated] processed human remains.

D.—E. (text unchanged)

.10 Disposition of [Cremated] Processed Human Remains.

A. Upon completion of the cremation or alkaline hydrolysis, insofar as is possible:

(1) All of the recoverable residue of the cremation or alkaline hydrolysis process shall be:

(a) Removed from the cremator or alkaline hydrolysis unit; and [:]

(b) Except for medical devices remaining after cremation or alkaline hydrolysis, processed; and

(2) The identification disc required by Health Occupations Article, §7-411, Annotated Code of Maryland, shall be:

(a) Removed from the cremator or alkaline hydrolysis unit; and

(b) Placed in the container with the [cremated] processed human remains.

B. Medical devices which remain after the completion of the cremation or alkaline hydrolysis process shall be treated as medical waste and disposed of accordingly.

C. (text unchanged)

D. If the [cremation] sealable container opening is not of adequate dimensions to accommodate an identification disc, it shall be affixed to the container and a record of the cremation number shall be [place] placed in the container.

E.—G. (text unchanged)

H. If processed human remains have been in the possession of a crematory authority, as originally authorized by the authorizing agent, without instructions for disposition, for a period of 10 days or more from the date of cremation or alkaline hydrolysis, the crematory authority may send the processed human remains, using the current mailing standard approved by the U.S. Postal Service, to the authorizing agent.

.11 Tools.

A. A crematory offering cremation shall maintain, at its own expense, the following tool inventory:

[A.] (1)—[I.] (9) (text unchanged)

B. A crematory offering hydrolysis shall maintain, at its own expense, the following tool inventory:

(1) Suitable tools for cleaning the alkaline hydrolysis unit;

(2) Brush with fine bristles for cleaning pulverizers;

(3) Mortar and pestle;

(4) Funnel;

(5) Hand magnet and metal detector wand to detect and remove metal from hydrolyzed human remains;

(6) Tweezers to remove nonmetal objects from hydrolyzed human remains;

(7) Dust masks; and

(8) An Occupational Safety and Health Administration compliant combination safety shower and eye wash station.

.12 Visitors.

A. The crematory permit holder or registered crematory operator shall:

(1) Submit to the Office the number of persons not affiliated with the operation of the crematory or alkaline hydrolysis unit who can safely be within the same room and within 10 feet of the cremator door; and

(2) (text unchanged)

B. Crematories that begin operation after July 1, 2014, shall construct a viewing room the area of the cremator or alkaline hydrolysis unit if the crematory authority intends to permit more than two visitors present in the area of the cremator or alkaline hydrolysis unit during a cremation.

09.34.09 Crematories — Code of Ethics

Authority: Business Regulation Article, §§5-204 and 5-310, Annotated Code of Maryland

.02 General Professional Practices.

A.—B. (text unchanged)

C. A permit holder or registered crematory operator may not:

(1) (text unchanged)

(2) Operate a crematory or perform a cremation or alkaline hydrolysis while under the influence of alcohol, an illegal drug, or a controlled dangerous substance which has not been prescribed by a physician.

DEBORAH RAPPAZZO

Director of the Office of Cemetery Oversight

Title 10
MARYLAND DEPARTMENT OF HEALTH

Subtitle 05 FREESTANDING AMBULATORY CARE FACILITIES

10.05.02 Freestanding Birthing Centers

Authority: Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland

Notice of Proposed Action

[25-068-P]

The Secretary of Health proposes to amend Regulations .01, .03—.08, .10—.12, propose new Regulations .02, .08, and .10, and recodify existing Regulations .02—.06., .07, and .08—.12 to be Regulations .03—.07, .09, and .11—.15 respectively of COMAR 10.05.02 Freestanding Birthing Centers.

Statement of Purpose

The purpose of this action is to set minimum, reasonable standards for licensure of Freestanding Birthing Centers in Maryland. OHCQ is proposing changes to 10.05.02 because of the need to:

(1) Incorporate more recent definitions and references;

(2) Add template language to clarify the enforcement process and protect a facility's right for an informal dispute resolution (existing authority and process has not changed); and

(3) Reflect current standards of care and strengthen quality and safety protocols.

This chapter is intended to maximize safety and quality of perinatal care services (services before, during, and after birth) in a non-hospital, non-residential setting. Revisions will support the opening of freestanding birth centers (there currently are none in operation) which would improve access to perinatal services for pregnant birthing persons.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Jordan Fisher Blotter, Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 W. Preston Street, Room 534, Baltimore, Maryland 21201, or call 410-767-0938, or email to mdh.regs@maryland.gov. Comments will be accepted through June 16, 2025. A public hearing has not been scheduled.

.01 Definitions.

A. (text unchanged)

B. Terms Defined.

(1) (text unchanged)

(2) "Certified nurse midwife" [means a registered nurse who is certified:] has the meaning stated in COMAR 10.27.05.01.

[(a) By the American College of Nurse Midwives Certification Council; and

(b) To practice nurse midwifery in this State by the Board.]

(3) (text unchanged)

(4) "Immediate action" means all actions the freestanding birthing center has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely.

(5) Immediate Jeopardy.

(a) "Immediate jeopardy" means a situation in which immediate corrective action is necessary because the freestanding birthing center's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public.

(b) “Immediate jeopardy” consists of three components:

(i) Noncompliance with this chapter;

(ii) Serious injury, harm, or death; and

(iii) The need for immediate action.

(6) “Informal dispute resolution (IDR)” means an informal process that provides a freestanding birthing center the opportunity to dispute one or more deficiencies cited in a written Statement of Deficiencies issued by the Department or the Department’s designee related to a recent survey.

(7) “Licensed certified midwife” has the meaning stated in Health Occupations Article, §8-6D-01, Annotated Code of Maryland.

(8) "Licensed direct-entry midwife” has the meaning stated in COMAR 10.64.01.01.

[(4)] (9) "Midwifery" means the antepartum, intrapartum, and postpartum management and care of [women] birthing persons and their newborns.

(10) "Need for immediate action" means that immediate corrective action is necessary to remove the jeopardy.

[(5)] (11) "Newborn" means an infant in the first [48 hours] 28 days of life.

(12) "Noncompliance" means the freestanding birthing center is non-compliant with one or more licensure requirements of this chapter.

[(6)] (13) Normal Maternity.

(a) (text unchanged)

(b) “Normal maternity” does not include the use of drugs for induction or augmentation of labor, general and regional anesthesia, vacuum extractors, forceps, recorded electronic fetal monitors, cesarean section, [or] surgical procedures other than episiotomy or perineal repair, care provided prior to 36 weeks gestation, or care provided after 42 weeks gestation.

[(7) "Nurse midwife services" means those services permitted to be provided by individuals licensed to practice nurse midwifery under Health Occupations Article, Title 8, Subtitle 6, Annotated Code of Maryland.]

(14) “Office of Health Care Quality (OHCQ)” means the Office of Healthcare Quality of the Maryland Department of Health.

(15) "Plan of Correction" means a written plan submitted by the freestanding birthing center to the OHCQ which documents steps the freestanding birthing center will take to come into compliance with the licensure requirements.

(16) "Removal of the immediate jeopardy" means that the freestanding birthing center has implemented the removal plan, and the OHCQ has verified that all actions the freestanding birthing center took were effective in removing the likelihood that serious injury, serious harm, serious impairment, or death would occur or recur.

(17) "Serious injury, harm, or death" means a situation which has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public.

(18) "Statement of Deficiencies" means the written notification that the OHCQ issues to the free standing birthing center that contains a listing of deficiencies cited that require correction.

.02 Incorporation By Reference.

In this chapter, the following document is incorporated by reference, National Fire Protection Association (NFPA) 101 Life Safety Code (2018 Edition), which is incorporated by reference in COMAR 29.06.01.06.

[.03] .04 Licensing Procedure.

[A freestanding birthing center shall submit a nonrefundable fee of $300 with an application for initial licensure or $300 with an application for license renewal.]

A. An applicant shall submit:

(1) An application on a written or electronic form provided by the Department;

(2) All other reasonable documents as required by the Department; and

(3) A business email address for the applicant or their organization.

B. License Application Administratively Closed.

(1) An application is not complete until the Department has received the completed license application and all required documents.

(2) After 180 calendar days from the date of initial receipt, the Department may deem an incomplete license application inactive and administratively close the application.

(3) An applicant whose application is administratively closed may reapply for a license by submitting a new application.

C. Voiding of License.

(1) Maryland State Department of Assessments and Taxation (SDAT).

(a) A freestanding birthing center shall remain in good standing with (SDAT).

(b) If the freestanding birthing center fails to return to good standing 60 calendar days after receipt of notification of noncompliance from SDAT or another government agency, the Department may void the freestanding birthing center's license.

(2) Ceases the Provision of Services.

(a) A license is void if the freestanding birthing center ceases to provide services to patients for a period of 180 consecutive days.

(b) The owner shall immediately cease all use of the previously issued freestanding birthing center license when the license is voided.

D. Current Business Email Address. A freestanding birthing center is required to maintain a current business email address on file with the OHCQ.

[.04] .05 [Surveys.] Inspection by OHCQ.

A.—C. (text unchanged)

D. Notice of Deficiencies.

(1) If a survey identifies noncompliance with a requirement, the Secretary shall:

(a) Issue a written Statement of Deficiencies that cites each deficiency;

(b) Require the freestanding birthing center to submit an acceptable Plan of Correction within 10 calendar days of receipt of the Statement of Deficiencies;

(c) Notify the freestanding birthing center of any sanctions or that failure to correct the violation may result in sanctions; and

(d) Offer the freestanding birthing center the opportunity for IDR.

E. Plan of Correction.

(1) The freestanding birthing center shall submit a written Plan of Correction to the OHCQ that documents steps the licensee will take to come into compliance, including:

(a) How the freestanding birthing center will correct each deficiency;

(b) The date by which each deficient practice will be corrected;

(c) How the freestanding birthing center will prevent the deficient practice from recurring; and

(d) Who will be responsible for ensuring the deficiency will not reoccur.

(2) Failure to return an acceptable Plan of Correction within the allotted time frame may result in a sanction.

(3) A request for an IDR does not change the freestanding birthing center's requirement to submit a Plan of Correction for all deficiencies within 10 calendar days after receipt of the notice of deficiency.

F. Immediate Jeopardy.

(1) Declaration of Immediate Jeopardy.

(a) When the OHCQ identifies a situation in which immediate corrective action is necessary because the freestanding birthing center's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public, an immediate jeopardy will be declared.

(b) The OHCQ shall provide the freestanding birthing center with a written notice that includes a description of the situation that constitutes an immediate jeopardy.

(2) Removal Plan. The freestanding birthing center shall submit a written removal plan to the OHCQ that includes:

(a) The immediate action a freestanding birthing center will take to prevent serious harm from occurring or recurring;

(b) All actions to remove past, present, and future jeopardy; and

(c) The date by which the freestanding birthing center asserts the likelihood for serious harm to any recipient no longer exists.

(3) OHCQ's Review of the Removal Plan.

(a) The OHCQ shall review the freestanding birthing center's removal plan to determine that the removal plan, if implemented appropriately, will remove the likelihood that serious harm will occur, or recur.

(b) The OHCQ shall verify that the freestanding birthing center has implemented the removal plan.

(4) OHCQ's Approval of the Removal Plan. The OHCQ shall approve the removal plan after verifying that all actions the freestanding birthing center took were effective in removing the likelihood that serious injury, serious harm, serious impairment or death would occur or reoccur.

(5) Plan of Correction. If an immediate jeopardy is identified during a survey, the Plan of Correction must completely correct all noncompliance associated with the immediate jeopardy.

G. Informal Dispute Resolution (IDR).

(1) A freestanding birthing center may request an IDR to dispute one or more deficiencies in a Statement of Deficiencies.

(2) The freestanding birthing center shall submit the request for an IDR to the Department within 10 calendar days of receiving the Statement of Deficiencies.

(3) The written request for an IDR shall fully describe the disagreement with the Statement of Deficiencies and be accompanied by all evidence for the Department’s consideration.

(4) At the discretion of the Department, the IDR may be held in person, by telephone, by video conference, or in writing.

(5) IDRs are informal in nature and are not attended by legal counsel representing the freestanding birthing center or the Department.

(6) The IDR process may not delay the effective date of any enforcement action.

(7) In the event a freestanding birthing center requests an IDR of a deficiency written by a designee of the Department, the Department shall request the designee to participate in the IDR process.

(8) There is no appeal of the Department’s decision in an IDR.

[.05] .06 Personnel.

A. (text unchanged)

B. Director of Midwifery Services. The administrator shall appoint a certified nurse midwife or licensed certified midwife as director of midwifery services who is responsible for the employment, training, and supervision of the licensed professional staff.

[C. A physician shall be on call and available to provide medical assistance to the freestanding birthing center whenever the center is treating a patient.]

[D.]C. [Medical Director] Clinical Director.

(1) The [medical] clinical director shall:

(a) Be a certified nurse midwife;

(b) Be a licensed certified midwife; or

(c) Be a physician with:

[(a)] (i) (text unchanged)

(ii) Appropriate experience in the care of pregnant and postpartum patients; and

[(2) Have staff privileges at a hospital licensed by this State; and]

[(3)] (d) (text unchanged)

(2) The same individual may be clinical director and the director of midwifery services.

[E.] D. Two licensed staff individuals, one of whom shall be a certified nurse midwife or licensed certified midwife, shall:

[attend] (1) Attend each birth; and

[. They shall be] (2) Be currently certified in:

[(1)] (a) Adult [CPR] cardiopulmonary resuscitation equivalent to the American Heart Association Class C basic life support; and

[(2)] (b) Neonatal [CPR] resuscitation by a course endorsed by the [equivalent to that of the] American Academy of Pediatrics and the American Heart Association.

[.06] .07 [Protocols] Clinical Practice Guidelines.

A. The [medical] clinical director and director of [nurse] midwifery shall develop [protocols] clinical practice guidelines for the management of routine and emergency care of the patient and [her] the fetus or newborn during pregnancy, birth, and postpartum through discharge, whether through completion of the pregnancy or referral or transfer to other levels of care.

B. The [protocols] clinical practice guidelines shall include, at a minimum, procedures for the:

(1) Transfer of patients or newborns for appropriate hospital obstetric and newborn care; [and]

(2) Monitoring of fetal heart tones consistent with the current standards of care; and

[(2)] (3) Use of ultrasound imaging that is:

(a) (text unchanged)

(b) Within the scope of practice for a:

(i) Physician; [or]

(ii) Certified nurse midwife[.]; or

(iii) Licensed certified midwife.

[B.]C. The administrator shall:

(1) Ensure that all [protocols] clinical practice guidelines are fully implemented by the clinical staff;

(2) Periodically review the [protocols] non-clinical policies and revise them when necessary; and

(3) Make the [protocols] clinical practice guidelines available to staff for reference on site at all times.

D. A licensed direct-entry midwife, certified nurse midwife, and licensed certified midwife practicing in a birthing center shall remain in compliance with applicable practice guidelines including but not limited to:

(1) Health Occupations Article, §8-6C-08, Annotated Code of Maryland;

(2) COMAR 10.64.01.10;

(3) COMAR 10.27.05.04; and

(4)COMAR 10.27.05.01(a)(8).

.08 Consultation.

A licensed direct-entry midwife, licensed certified midwife, certified nurse midwife, or physician shall consult or collaborate with another health care practitioner who has the knowledge, skills, and expertise to manage a clinical issue, as needed or as required in Health Occupations Article, §8-6C-04, Annotated Code of Maryland.

[.07] .09 [Referral System.] Referrals.

[A freestanding birthing center shall have a system for consultation with and referral to a physician who is Board-certified in a specialty that provides services for pregnant and postpartum patients, or a physician who has appropriate experience in the care of pregnant and postpartum patients.] A licensed direct-entry midwife, licensed certified midwife, certified nurse midwife, or physician shall refer and transfer patients with complications beyond their scope of practice to a health care practitioner with the knowledge, skills, and experience to manage the client.

.10 Hospitalization.

A. A freestanding birthing center shall have a written procedure for the transfer of patients to a nearby hospital when care beyond the capabilities of the facility is required.

B. Procedures for emergency transfer to a hospital shall include, at minimum:

(1) Written clinical practice guidelines related to emergency transfer procedures;

(2) A mechanism for notifying the hospital of a pending emergency case;

(3) A mechanism for arranging appropriate transportation to the hospital; and

(4) Protocols for transmitting a copy of the patient’s medical record to the hospital.

C. A freestanding birthing center shall conduct a transfer drill with staff that may be involved in patient transfers at least once a year.

[.08] .11 Quality Assurance Program.

A.—B. (text unchanged)

C. A freestanding birthing center shall conduct a quarterly review of all patients transferred to an emergency department or a hospital.

D. Process of Filing a Complaint. The freestanding birthing center shall have a written process that describes how patients are notified of how to file a complaint with the OHCQ and, if applicable, an accreditation organization.

[.10] .13 Fire Safety and Emergency Preparedness.

A. (text unchanged)

B. Power Outage. A freestanding birthing center shall have:

(1) A written plan to address power outages; and

(2) Annual staff training relating to power outages.

[B.] C. Evacuation.

(1) (text unchanged)

(2) A freestanding birthing center shall keep all personnel informed of their responsibilities under the plan and conduct a supervised evacuation [drills] drill at [regular intervals] least once a year.

[C. Transfer of Patients.

(1) A freestanding birthing center shall have emergency transportation available at all times, as demonstrated by:

(a) A written agreement with an ambulance service;

(b) Evidence that the center has confirmed that municipal ambulance services are available; or

(c) When located on the grounds of an acute care hospital, a written protocol which describes emergency transportation by means other than ambulance.

(2) A freestanding birthing center shall have a procedure for emergency communication with the ambulance service, or other emergency transportation mechanisms.]

[.11] .14 Equipment.

A. Equipment and furnishings shall be constructed of materials that are easily cleaned and maintained and shall include, at a minimum:

(1) (text unchanged)

(2) A transfer [incubator or] isolette or demonstrated capability of ready access to a transfer [incubator] isolette;

(3)—(5) (text unchanged)

(6) Oxygen equipment for patient and newborn that is stored in accordance with Standards for Health Care Facilities, NFPA 99[, which is incorporated by reference as part of COMAR 29.06.01.06B(2)]; and

(7) (text unchanged)

B. (text unchanged)

[.12] .15 Health Record.

A. (text unchanged)

B. The health record of each patient shall contain documentation of all services provided while the patient and [her] the fetus or newborn are under the care of the freestanding birthing center, including reports by outside providers who have examined or treated the patient at the request of the center.

C. (text unchanged)

LAURA HERRERA SCOTT

Secretary of Health

Subtitle 63 COMMUNITY-BASED BEHAVIORAL HEALTH PROGRAMS AND SERVICES

Notice of Proposed Action

[25-063-P]

The Acting Secretary of Health proposes to:

(1) Repeal existing Regulations .01—.05 and adopt new Regulations .01—.13 under COMAR 10.63.01 General Compliance and Reporting Requirements; .

(2) Repeal existing Regulations .01—.04 and adopt new Regulations .01—.14 under COMAR 10.63.02 General Staffing Requirements;

(3) Repeal existing Regulations .01—.21 and adopt new Regulations .01—.10 under COMAR 10.63.06 Licensure Process;

(4) Adopt new Regulations .01—.10 under a new chapter, COMAR 10.63.09 Corrective Actions and Sanctions.

Statement of Purpose

The purpose of this action is to repeal existing regulations within COMAR 10.63 (Community Behavioral Health Programs and Services) to align with current statutory requirements and include additional regulatory requirements to support improved quality of services compliance and provide a more equitable and sustainable operating environment for community-based behavioral health programs in the State.

(1) COMAR 10.63.01 sets forth compliance and reporting requirements for all organizations operating programs to provide community-based behavioral health services;

(2) COMAR 10.63.02 outlines general staffing requirements;

(3) COMAR 10.63.06 concerns the application and licensure process; and

(4) COMAR 10.63.09 provides the regulatory framework for corrective actions and sanctions undertaken by the Behavioral Health Administration for material and egregious non-compliance with federal or State law or regulation.

Estimate of Economic Impact

I. Summary of Economic Impact. The proposed regulations will have an economic impact for the Department. The proposed regulations update and add requirements for accreditation-based and non-accreditation-based licenses which subsequently add to the review and approval of licensure applications by the Department before licenses are issued. In this manner, the proposed regulations increase expenditures in the required staffing levels, training, and systems support needed to implement the changes to licensure requirements. The amount of these increased expenditures is indeterminable as any method used to project the effect of the proposed regulations on the current volume of licensure applications is speculative.

For organizations operating programs to provide community behavioral health services, the cost of adhering to the proposed regulations that update and clarify application requirements for accreditation-based and non-accreditation-based licenses is indeterminable, as any costs will vary by organization, number of sites and the program type(s) they are seeking licensure for in the State. For certain program types, the proposed regulations update staffing requirements which may include changes to required staff credentials, staffing levels, site requirements, program requirements, and management requirements for licensure. The proposed regulatory package also updates and clarifies program requirements for certain program types, which may also generate regulatory burden and associated compliance costs.

Some local governments functioning as the Local Behavioral Health Authority or the Local Addiction Authority may provide substance-related disorder services, and which may require the local government agencies to be accredited. The amount of agencies that would need to be accredited cannot be determined as it will vary between local governments.

II. Types of Economic Impact.

Impacted Entity	Revenue (R+/R-) Expenditure (E+/E-)	Magnitude
A. On issuing agency:
Maryland Department of Health	(E+)	Indeterminable
B. On other State agencies:	NONE
C. On local governments:
Local Behavioral Health Authorities/Local Addiction Authorities	(E+)	Unquantifiable
	Benefit (+) Cost (-)	Magnitude
D. On regulated industries or trade groups:
(1) Licensed Community-Based Behavioral Health Organizations	(-)	Indeterminable
(2) Licensed Community-Based Behavioral Health Organizations	(+)	Indeterminable
(3) Administrative Service Organization	(+)	Unquantifiable
E. On other industries or trade groups:
(1) Behavioral Health Consultants	(+)	Indeterminable
(2) Community Behavioral Health Trade Groups	(+)	Indeterminable
(3) Accrediting Organizations	(-)	Indeterminable
F. Direct and indirect effects on public:
(1) Indirect Effects on Quality of Care	(+)	Indeterminable
(2) Indirect Effects on Access to Care	(+)	Unquantifiable
(3) Indirect Effects on Access to Care	(-)	Unquantifiable

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

A. These new requirements add to the review and approval of licensure applications by the Department before licenses are issued. In this manner, the proposed regulations increase expenditures in the required staffing levels, training, and systems support needed to implement the changes to licensure requirements. The amount of these increased expenditures is indeterminable.

C. Additional expenditures may be related to increased audit and compliance activities and any increased regulatory burden. At this time, the impact is unquantifiable.

D(1). The Department anticipates that increased program and compliance activities and increased regulatory burden may result in additional costs for organizations.

D(2). The Department anticipates that a reduction in fraud, waste, and abuse within the provider community may result in benefits for organizations as a whole, but any exact amount of benefit would be indeterminable.

D(3). The Department anticipates that a reduction in fraud, waste, and abuse within the provider community may result in a benefit for the Administrative Service Organization. At this time, the impact is unquantifiable.

E(1). The Department anticipates that Behavioral Health Consultants may have additional opportunities to assist regulated organizations with compliance with these regulations and the new licensure process. Any exact amount of benefit would be indeterminable.

E(2). The Department anticipates that Community Behavioral Health Trade Groups may see an increased need for support among association members to comply with new regulatory requirements. Any exact amount of benefit would be indeterminable.

E(3). The Department understands that as a result of these regulations, accreditation organizations may see less organizations operating programs providing community-based behavioral health services seeking accreditation. Any cost associated with this would be indeterminable.

F(1). The Department strongly believes that these new regulatory requirements will result in better providers and better overall quality of care as a result. Nevertheless, any exact amount of this benefit is indeterminable.

F(2). The Department strongly believes that these new regulatory requirements will result in a higher quality of care and an improved access of care for community-based behavioral health programs.

F(3). The Department appreciates that these new regulatory requirements may result in the closure of some community-based behavioral health programs over time, any exact impact would be unquantifiable.

Economic Impact on Small Businesses

An analysis of this economic impact follows:

The proposed action has a meaningful economic impact on small businesses. For organizations operating community behavioral health programs, many of which are small businesses, the cost of adhering to the proposed regulations that update and clarify application requirements for accreditation-based and non-accreditation-based licenses is indeterminable, as costs will vary by organization, number of sites, and the program type(s) they are seeking licensure for in the State. For certain program types, the proposed regulations update staffing requirements which may include changes to required staff credentials, staffing levels, site requirements, program requirements, and management requirements for licensure all of which may increase operating costs, compliance costs and general regulatory burden.

Impact on Individuals with Disabilities

The proposed action has an impact on individuals with disabilities as follows:

To the extent that individuals with disabilities receive community-based behavioral health services, the Department believes that these regulations will result in better care for individuals receiving these services. Overall, the Department anticipates a positive impact and an improved quality of care.

Opportunity for Public Comment

Comments may be sent to Jordan Fisher Blotter , Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 534, Baltimore, Maryland 21201, or call 410-767-0938, or email to mdh.regs@maryland.gov. Comments will be accepted through June 16, 2025. A public hearing has not been scheduled.

10.63.01 [Requirements for All Licensed Programs] General Compliance and Reporting Requirements

Authority: Health-General Article, [§§7.5-204, ] §§7.5-204 (a)(2), [8-402, 8-404,] and [10-901] 7.5-402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) "Accreditation organization" means a private entity that conducts inspections and surveys of health care facilities or health care staff agencies based on nationally recognized and developed standards that is approved by the Secretary in accordance with Health General Article, §19-2302, Annotated Code of Maryland.

(2) "Accreditation" means the approval granted to a program by an accreditation organization.

(3) "Accreditation-based license" means a license which requires that the organization be accredited by an approved accreditation organization.

(4) "Administration" means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed in accordance with this subtitle.

(5) "Agreement to cooperate" means a written agreement between an organization operating a program and the appropriate local authority that provides for coordination and cooperation in carrying out behavioral health activities in a given jurisdiction.

(6) "Applicant" means the legally authorized individual or entity submitting an application for licensure.

(7) "Behavioral health services" means prevention, screening, early intervention, treatment, recovery, support, wraparound, and rehabilitation services for individuals with substance-related disorders, addictive disorders, mental disorders, or a combination of these disorders.

(8) "Business day" means any day except Saturday, Sunday, or a State holiday.

(9) "Community-based" means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(10) Corporate Officers.

(a) “Corporate officers” means the managing employees or other individuals responsible for the conduct of the affairs of the organization inclusive of the organization’s controlling board.

(b) “Corporate officers” includes but is not limited to the organization's:

(i) Chief Executive Officer;

(ii) Chief Financial Officer;

(iii) Chief Medical Officer;

(iv) Chief Information Officer;

(v) Corporate Compliance Officer;

(vi) Board members; and

(vii) Other senior officers of the organization.

(11) "Corrective action" means specific actions undertaken by an organization to address a violation of any local, state, or federal law or regulation.

(12) "Critical incident" means an event that impacts the health, safety, or welfare of a program participant or staff.

(13) "Department" means the Maryland Department of Health.

(14) "Discontinuation plan" means an organization's written plan which is provided to the Administration when the organization intends to discontinue program or licensed service operations.

(15) Experimental Project.

(a) “Experimental project” means a project, irrespective of funding, that if deemed successful, may be considered and adopted as a permanent policy or program.

(b) “Experimental project” includes:

(i) Demonstration projects; or

(ii) Pilot projects.

(16) "Family support services " has the meaning stated in Health-General Article, §7.5-101, Annotated Code of Maryland.

(17) "Group practice" has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland.

(18) "Guardian" has the meaning stated in Estates and Trusts Article, §13-101, Annotated Code of Maryland.

(19) "Jurisdiction" means Baltimore City or one of the 23 counties in the State.

(20) "License" means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(21) "Licensed mental health professional" means a practitioner authorized under Health Occupations Article, Annotated Code of Maryland, who has specialty in the diagnosis and treatment of mental health, addictive, substance-related, or co-occurring disorders.

(22) Local Authority.

(a) “Local authority” means the designated county or multicounty authority responsible for planning, managing, and monitoring publicly funded mental health, substance-related, or addictive disorder services.

(b) “Local authority” includes the:

(i) Core service agency as defined in Health General Article, §7.5-101(g), Annotated Code of Maryland;

(ii) Local addictions authority as defined in Health General Article, §7.5-101(j), Annotated Code of Maryland; and

(iii) Local behavioral health authority as defined in Health General Article, §7.5-101(k), Annotated Code of Maryland.

(23) "Medically necessary" means a service or benefit that is:

(a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;

(b) Consistent with current accepted standards of good medical practice;

(c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and

(d) Not primarily for the convenience of the participant, family, provider, or organization.

(24) "Organization" means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(25) "Participant" means an individual receiving behavioral health services in a community-based program.

(26) "Peer support services" has the meaning stated in Health-General Article, §7.5-101, Annotated Code of Maryland.

(27) "Plain language" means language which is easily understandable by program participants and takes into account the various levels of education and understanding of the population.

(28) Plan of Care.

(a) “Plan of care” means a medically necessary care plan which is responsive to an individual’s goals, values, and preferences while considering the individual’s needs respective to their behavioral health condition.

(b) "Plan of care" includes but is not limited to:

(i) An individualized treatment plan; and

(ii) An individualized rehabilitation plan.

(29) "Program" means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of §B(29)(a)—(c) of this regulation.

(30) "Public behavioral health system" means the system that provides medically necessary behavioral health services for Medical Assistance participants and certain other uninsured individuals.

(31) "Recovery residence" means a program certified under this subtitle to provide alcohol and illicit drug-free housing to individuals with substance-related disorders, addictive disorders, or co-occurring mental health and substance-related disorders or addictive disorders.

(32) "Residential" means the setting of a community-based program in which program participants both reside and receive behavioral health services.

(33) "Secretary" means the Secretary of the Maryland Department of Health or their designee.

(34) "Site" means the location where the organization operates the program as detailed on the program’s license.

(35) "Telehealth" means the synchronous delivery of medically necessary services to a participant at an originating site by a distant site provider, through the use of technology-assisted communication in accordance with COMAR 10.09.49.

.02 Programs Requiring License.

A. Except as provided in §C of this regulation, an organization shall have a valid and current license issued by the Secretary in accordance with COMAR 10.63.06 to operate a program which provides community-based behavioral health services in the State.

B. A license issued in accordance with COMAR 10.63.06 may not be transferred.

C. In accordance with Health-General Article, §7.5-401, Annotated Code of Maryland, the following do not fall within any of the program descriptions set forth in this subtitle which require a license in accordance with COMAR 10.63.06:

(1) A health professional in either a solo or group practice, who is:

(a) Licensed under the Health Occupations Article, Annotated Code of Maryland; and

(b) Providing behavioral health services in accordance with the requirements of the appropriate professional board;

(2) Alcoholics Anonymous, Narcotics Anonymous, peer support services, family support services, or other similar organizations, if the organization holds meetings or provides support services but does not provide any type of treatment;

(3) Employees’ assistance programs of a business or State entity;

(4) Outpatient behavioral health treatment and rehabilitation services accredited by an approved accreditation organization provided in regulated space of a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland;

(5) Federally qualified health center providing primary health services in accordance with 42 USC §254b; and

(6) Private therapeutic group homes authorized under:

(a) Health-General Article, §§10-920—23, Annotated Code of Maryland;

(b) COMAR 10.21.07; or

(c) COMAR 14.31.05—.07.

D. Recovery Residences.

(1) Recovery residences are exempt from the licensure requirements set forth in §A of this regulation.

(2) Recovery residences are required to be certified by the Maryland Certification of Recovery Residences in accordance with the program description set forth in this subtitle.

E. The Administration may exempt an organization from the requirements of this subtitle if the program:

(1) Is an experimental project or does not fall within any of the program descriptions set forth in this subtitle; and

(2) At the satisfaction of the Administration, is proved to be subject to contractual provisions, conditions of grant award, or other requirements that are comparable to the requirements of this subtitle.

.03 Compliance with State and Federal Law and Regulation.

A. An organization licensed in accordance with COMAR 10.63.06 to operate a program to provide community-based behavioral health services in the State shall comply with all applicable requirements of this subtitle.

B. An organization licensed in accordance with COMAR 10.63.06 to operate a program shall comply with all applicable federal and State laws and regulations, including, but not limited to:

(1) The Health Insurance Portability and Accountability Act, 42. U.S.C. §§1320d—1320d-9, and implementing regulations at 45 C.F.R. Part 160 and 164;

(2) Federal regulations on confidentiality of substance use disorder patient records, 42 CFR Part 2;

(3) State confidentiality statutes, including:

(a) Health-General Article, §§4-301—4-310, Annotated Code of Maryland;

(b) General Provisions Article, §§4-101—4-601 Annotated Code of Maryland; and

(c) Current applicable State confidentiality regulations;

(4) The Americans With Disabilities Act, 42 U.S.C. §§12101—12213;

(5) The federal Fair Housing Act, 42 U.S.C. §3604;

(6) The Eliminating Kickbacks in Recovery Act, 18 U.S.C. §220; and

(7) Labor and Employment Article, Title 3, Annotated Code of Maryland.

C. Organizations Advertising or Offering Housing for Program Participants. Any organization advertising or offering housing for program participants shall comply with Real Property Code, Title 8, Annotated Code of Maryland, and any local requirements, regardless of whether housing is provided directly by the organization or program or through a referral to another organization.

.04 Compliance with Accreditation Standards.

An organization operating a program to provide community-based behavioral health services with an accreditation-based license shall:

A. Comply with all requirements and standards of the accreditation organization by which it is accredited;

B. Provide behavioral health services only to populations for which it is accredited; and

C. Notify the Administration in writing within 5 business days of any change in accreditation status.

.05 Corporate Compliance Requirements.

A. An organization shall document and implement a corporate compliance plan covering each program it operates.

B. An organization’s compliance plan shall:

(1) Meet the standards established by the applicable accreditation organization for its operated program or services; or

(2) For organizations without an applicable accreditation organization compliance standard, meet the standards outlined in §C of this regulation.

C. Corporate Compliance Standards. A corporate compliance plan shall include the:

(1) Implementation of policies and procedures covering compliance in key areas of the organization’s provision of behavioral health care services, including, at a minimum:

(a) Billing;

(b) Coding;

(c) Confidentiality;

(d) Documentation;

(e) Ethical behavior;

(f) Preventing illegal service and referral incentives; and

(g) Contingency planning in case of a loss of key staff or capacity to serve program participants;

(2) Appointment of a corporate compliance officer;

(3) Implementation of a no-fault reporting system for compliance issues that ensures that whistleblowers are not subject to punitive actions;

(4) Documentation of a policy statement indicating a prohibition of conflicts of interest between the organization and program participants;

(5) Implementation of a strategy for risk assessment, auditing, and monitoring which includes:

(a) A documented annual review of risk areas in the organization;

(b) Succession and contingency plans for the organization; and

(c) An audit program with at least four audits a year that is focused on proper documentation, billing, and coding practices in high risk areas;

(6) A process for documentation of the organization’s responses to critical incidents in accordance with Regulation .06 of this chapter and the development of any necessary corrective actions;

(7) Investigation of any violations of State or federal law or regulation, or organizational policy; and

(8) Organization’s procedure in the event of any violation of State or federal law or regulation, or organizational policy including the:

(a) Implementation of any necessary corrective action; and

(b) Submission of any required reports to the Administration or other applicable State, local, or federal authority.

.06 Reporting Requirements.

A. Critical Incident Reporting.

(1) An organization operating a community-based behavioral health program shall report the following critical incidents to the Administration:

(a) Any death of a program participant;

(b) Injuries to program participants that are:

(i) Life-threatening; or

(ii) The result of interpersonal violence;

(c) The following sexual activity:

(i) Consensual sexual activity between a current program participant and a member of the organization’s staff, including volunteers or consultants associated with the program or the organization operating the program; and

(ii) Non-consensual sexual activity between a current or former program participant and a member of the organization’s staff including volunteers or consultants associated with the program or the organization operating the program;

(d) Any unexpected evacuation of a program site under circumstances that threaten the life, health, or safety of program participants;

(e) Any fatal or non-fatal overdose of a program participant;

(f) Suspected or alleged abuse, neglect, or exploitation of a program participant;

(g) A disease or condition listed in the List of Reportable Diseases or Conditions, as set forth in COMAR 10.06.01.03 in addition to the reporting requirements of COMAR 10.06.01.04 for any program participant or organization staff;

(h) Any suicide attempt by either:

(i) A current program participant; or

(ii) A former program participant within 30 days following discharge;

(i) Any credible threat by a program participant determined by the organization to represent a risk to the life, health, or safety of staff, other program participants, targeted individuals, or the general public;

(j) A program participant’s violation of an order of conditional release from a State psychiatric hospital;

(k) From a program that administers, dispenses, monitors or stores medication:

(i) Any theft of medication;

(ii) Any unexplained loss of medications; and

(iii) Any medication error that requires medical intervention;

(l) Any disappearance or elopement of one of the following program participants from a residential program site:

(i) A child;

(ii) A vulnerable adult;

(iii) An older adult; or

(iv) An adult with a behavioral health or somatic condition that if left unattended or untreated would be life threatening; and

(m) Any other serious incident as determined by the Administration that threatens the life, health, or safety of program participants.

(2) An organization shall report all critical incidents to the Administration, or its designee, on the form provided by the Administration within 3 business days of the organization’s knowledge of the critical incident.

(3) An organization's failure to report a critical incident in accordance with §A(1)—(2) of this regulation may result in a civil money penalty in accordance with COMAR 10.63.08.

B. Organization Financial Status Reporting.

(1) An organization shall notify the Administration of changes in the financial condition of the organization that may affect its ability to operate a program to provide behavioral health services including, at minimum:

(a) Filing of bankruptcy;

(b) Any wage claim against the organization;

(c) Notification of failure to pay State or federal taxes;

(d) Any foreclosure action against the organization filed in Circuit Court;

(e) Any of the following District Court actions filed against the organization:

(i) Failure to pay rent; or

(ii) Breach of lease;

(f) Any utility shut-off notice due to non-payment;

(g) Any legal actions brought against the organization or the organization’s owner seeking to recover greater than $15,000; and

(h) Any other action which may affect the organization’s ability to operate a program.

(2) An organization shall report all changes in the financial condition to the Administration, or its designee, on the form provided by the Administration within 3 business days of the organization’s knowledge of the change in the financial condition.

(3) An organization's failure to report a change in the financial condition in accordance with §B(1)—(2) of this regulation may result in a civil money penalty in accordance with COMAR 10.63.08.

C. Program Outcomes Reporting.

(1) The organization shall provide data elements to the Administration at the frequency required by the Administration if:

(a) The program’s provided behavioral health services are funded by the federal Substance Abuse and Mental Health Services Administration and related federal funding sources; and

(b) The organization bills the public behavioral health system for either:

(i) Specialty mental health services in accordance with COMAR 10.09.59; or

(ii) Community-based substance use disorder services in accordance with COMAR 10.09.80.

(2) The data elements provided to the Administration shall be in accordance with federal requirements set forth in:

(a) 42 U.S.C. §300x-9;

(b) 42 U.S.C. §300x-35;

(c) 42 U.S.C. §300x-52(a); and

(d) 42 U.S.C. §300x-53(a).

D. An organization shall report vacancies in accordance with COMAR 10.63.02.03.

.07 Site Requirements.

A. Licensed Program Site Location Requirements.

(1) An organization’s licensed program site shall be located in the State.

(2) An organization may not have a licensed program site:

(a) In a manner inconsistent with federal, State, or local law, ordinance, or regulation inclusive of zoning requirements;

(b) If providing outpatient behavioral health services on the same site as a residential dwelling; or

(c) If providing residential behavioral health services on the same site as any other licensed healthcare service.

(3) Accessibility.

(a) A program shall be accessible to program participants and others involved in their care during its approved operating hours.

(b) Accessibility includes but is not limited to:

(i) Compliance with the federal Americans with Disabilities Act, 42 U.S.C. §§12101—12213;

(ii) The provision of translation services as necessary to meet the needs of program participants; and

(iii) The provision of deaf and hard of hearing services necessary to meet the needs of program participants.

(4) Regardless of the amount of services provided by telehealth, the organization shall have sufficient space on its licensed program site to:

(a) Provide confidential behavioral health services during operating hours; and

(b) Provide the behavioral health services which it is licensed to provide, including group services.

(5) If an organization utilizes a shared space for a program providing community-based behavioral health services, the organization shall maintain confidentiality in accordance with the requirements of Regulation .03 of this chapter.

B. Post-Licensing Inspections.

(1) The Administration or its designee may make announced or unannounced visits to inspect an organization at:

(a) A licensed program site;

(b) An administrative office; or

(c) Any other location deemed necessary for the health, safety, or welfare of program participants.

(2) The Administration, or its designee, has the authority to inspect, scan, and copy business records of the organization or program, including but not limited to:

(a) Financial records;

(b) Treatment records;

(c) Service records;

(d) Staffing records; and

(e) Policies and procedures.

(3) The Administration, or its designee, may inspect an organization operating a program providing behavioral health services to:

(a) Determine compliance with any accreditation standards;

(b) Follow-up on any issue identified by the organization’s accreditation organization;

(c) Validate the findings of the organization’s accreditation organization;

(d) Investigate any critical incidents; or

(e) Determine compliance with any State or federal law or regulation.

.08 Documentation Requirements.

A. Medical Records. An organization shall maintain documentation of all behavioral health services provided to program participants, to include, at minimum, the following:

(1) The date of service with service start and end times;

(2) The program participant’s primary behavioral health complaint or the reason for the visit;

(3) A brief description of the service provided, including progress notes and any referrals for additional services;

(4) The place of service;

(5) Whether the service is by telehealth, and, if so, the location of both the licensed mental health professional and the program participant;

(6) A statement indicating that the program participant received copies of:

(a) The organization’s grievance policy; and

(b) Any necessary billing documents; and

(7) A signature block which may be handwritten or electronic which includes the following for the licensed mental health professional:

(a) Printed name;

(b) Title;

(c) Signature; and

(d) Date.

B. Confidentiality. An organization shall maintain program medical records and confidential information:

(1) According to the requirements of Regulation .03 of this chapter; and

(2) At the licensed program site in a location that is:

(a) Exclusively controlled by the organization; and

(b) Locked.

C. Timekeeping. An organization shall maintain timekeeping records in accordance with COMAR 09.32.01.06 for required staff enumerated in COMAR 10.63.02 or in any of the program descriptions set forth in this subtitle and contractors, including physicians and nurse practitioners.

.09 Telehealth Service Requirements.

A. Scope. This regulation applies to community-based behavioral health services delivered via synchronous telehealth which are eligible for reimbursement by the Public Behavioral Health System.

B. Covered Services. In accordance with COMAR 10.09.49.03, community-based behavioral health services delivered via telehealth shall be:

(1) Medically necessary;

(2) Provided to the same extent and standard of care as services provided in person;

(3) Within a licensed behavioral health professional’s scope of practice; and

(4) Permitted to be provided via telehealth as set forth in the chapter of this subtitle defining the covered service being rendered.

C. The organization shall ensure that all licensed mental health professionals obtain the program participant’s consent to services via telehealth, unless there is an emergency that prevents obtaining consent, which shall be documented in the program participant’s medical record.

D. Medical Record Documentation. The organization shall ensure medical records for services rendered via telehealth:

(1) Maintain documentation in the same manner as during an in-person visit, using either electronic or paper medical records;

(2) Are retained according to the provisions of Health-General Article, §4-403, Annotated Code of Maryland; and

(3) Include program participant consent documentation as required in §C of this regulation.

E. Technical Requirements. An organization operating a program providing community-based behavioral health services shall meet all technical requirements described in COMAR 10.09.49.05.

F. Confidentiality. An organization operating a program providing community-based behavioral health services shall meet all requirements described in:

(1) COMAR 10.09.49.06; and

(2) Regulation .03 of this chapter.

G. Limitations. An organization operating a program providing community-based behavioral health services is subject to the following limitations on the provision of a service delivered via telehealth:

(1) A service delivered via telehealth is subject to the same program restrictions, preauthorizations, limitations, and coverage requirements that exist for services delivered in person.

(2) A service delivered via telehealth does not include:

(a) An audio-only telephone conversation between a licensed mental health professional and a program participant unless provided on dates of service between July 1, 2021, and June 30, 2023, inclusive;

(b) An electronic mail message between a licensed mental health professional and a program participant;

(c) A facsimile transmission between a licensed mental health professional and a program participant; or

(d) A telephone conversation, electronic mail message, or facsimile transmission between a licensed mental health professional without direct interaction with the program participant.

(3) Program specific limitations as set forth in the chapter of this subtitle defining the covered service being rendered.

.10 Agreement with Local Authorities.

A. An organization that intends to operate a program to provide community-based behavioral health services in the State shall execute an agreement to cooperate with the applicable local authority in each jurisdiction in which they intend to provide behavioral health services prior to applying for a license for any program licensed under this subtitle.

B. The agreement to cooperate shall provide for coordination and cooperation between the organization and local authority in the jurisdiction that services are to be provided, including, but not limited to, facilitating:

(1) Any site visit, including but not limited to a complaint or critical incident investigation;

(2) The transition of services if:

(a) The organization closes any of its program sites; or

(b) An organization plans to close or discontinue a service;

(3) Program compliance audits; and

(4) The provision of any additional documentation requested by the Administration.

C. The agreement to cooperate may not include a provision that authorizes the local authority to prohibit an organization from offering services at any location.

D. The agreement to cooperate shall be included with the licensure application provided to the Administration in accordance with COMAR 10.63.06.03.

.11 Rights of Program Participants.

A. An organization may not discriminate in the provision of community-based behavioral health services on the basis of race, creed, color, age, gender, sexual orientation, gender identity, national origin, marital status, disabilities, or any other classification prohibited under State or federal law in accordance with the requirements of Regulation .03 of this chapter.

B. An organization shall protect and promote the exercise of the program participant rights enumerated in §D of this regulation in all aspects of its program operations.

C. Notification of Program Participant Rights. The organization shall inform the program participant, in a language that the participant understands, of:

(1) The rights and responsibilities listed in §D of this regulation; and

(2) The Suicide and Crisis Hotline.

D. Program Participant Rights.

(1) An organization shall provide care for program participants in a manner and in an environment that maintains or enhances each participant’s dignity and respect.

(2) A program participant receiving community-based behavioral health services from an organization licensed in accordance with COMAR 10.63.06 has the right to:

(a) Be treated with consideration, respect, and full recognition of the program participant’s human dignity and individuality;

(b) Receive treatment, care, and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations;

(c) Receive treatment in accordance with their individualized plan of care or rehabilitation plan;

(d) If applicable, receive treatment in accordance with the preferences of their advance directive for mental health services in accordance with Health-General, §10-708, Annotated Code of Maryland;

(e) Consent to or refuse treatment after the possible consequences of refusing treatment are fully explained;

(f) Be free from mistreatment, neglect, and verbal, mental, emotional, sexual, and physical abuse;

(g) Contact at any time:

(i) Personal legal counsel;

(ii) The State protection and advocacy agency;

(iii) The applicable local authority;

(iv) The Administration; and

(v) The Department.

(h) Make suggestions, complaints, or present grievances on behalf of the program participant or others, to the organization, the State protection and advocacy agency, the applicable local authority, the Administration, the Department, or other individuals without threat or fear of retaliation;

(i) Receive a prompt response, through the organization’s established complaint or grievance policy, to any complaints, suggestions, or grievances the program participant may have;

(j) Except when prohibited for the health and safety of the program participant or others, keep any identification, insurance information, and public benefits documentation in their possession;

(k) Designate their own representative payee for Social Security;

(l) Authorize advocates, family, or friends to participate in care coordination or the treatment planning and discharge planning process;

(m) Contact emergency services for emergency assistance or transportation to a hospital at any time; and

(n) Not be compelled to perform work for the organization and, if the program participant chooses to perform work for the organization, is monetarily compensated by the organization for any work performed.

E. Addressing Alleged Violations of Participant Rights. An organization licensed to operate a program to provide community-based behavioral health services in accordance with COMAR 10.63.06 shall:

(1) Initiate an investigation within 3 business days into any alleged violations of program participant rights involving anyone furnishing services on behalf of the organization;

(2) Document any actions taken to prevent further violations while the alleged violation is investigated;

(3) Investigate and document all alleged violations in accordance with the organization’s written policies as outlined in §F of this regulation;

(4) Take any corrective action required by the local authority or the Administration; and

(5) Report any critical incidents in accordance with Regulation .06 of this chapter.

F. Program Participant Rights Policy. An organization operating a community-based behavioral health program shall have a written policy to investigate and document all alleged violations of participant rights that, at minimum, outlines:

(1) The timeline of the investigation;

(2) The procedure for private interviews with any witnesses;

(3) Any necessary safeguards to ensure that the alleged perpetrator is not involved in conducting the investigation;

(4) The procedure for the review of the program participant’s file and other relevant records;

(5) Action taken based on the organization’s written policies; and

(6) The procedure for the completion and submission of documentation relevant to the investigative process to the local authority or the Administration.

.12 Organization Grievance Policy.

A. Grievance Policy. An organization operating a community-based behavioral health program shall have a grievance policy.

(1) An organization shall provide program participants with a copy of the grievance policy at the time of admission.

(2) An organization’s grievance policy shall include at a minimum:

(a) The right of program participants to grieve program decisions including, but not limited to, decisions concerning:

(i) Treatment;

(ii) Violations of program participant rights;

(iii) Discharge; and

(iv) Change in status or services;

(b) Instructions on how to file a grievance as described in §B of this regulation; and

(c) Procedures for the following:

(i) Review of the initial decision on the grievance by supervisory staff;

(ii) An opportunity to appeal the outcome of the initial decision to senior management; and

(iii) Explicit provisions that allow the program participant at any time to contact the appropriate local authority, the Administration, and if applicable, the accreditation organization.

B. An organization operating a program providing community-based behavioral health services shall provide program participants instructions on how to file a grievance which shall:

(1) Be in plain language;

(2) Be in a language that the program participant understands;

(3) Accommodate individuals who are unable to read print or communicate in writing;

(4) Outline the steps of the grievance process as described in §A(2)(c) of this regulation; and

(5) Contain current contact information for the appropriate local authority, the Administration, and if applicable, the accreditation organization.

C. An organization operating a program providing community-based behavioral health services may not retaliate against a program participant who presents a grievance.

D. An organization operating a program providing community-based behavioral health services shall inform each program participant in writing when revisions are made to the grievance policy and communicate to program participants the nature and extent of the changes.

.13 Discontinuation of Program Operations.

A. Planned Discontinuation of Program Operations.

(1) An organization operating a program providing community-based behavioral health services shall notify the following no less than 60 business days prior to the intended discontinuation date:

(a) The Administration;

(b) The appropriate local authority; and

(c) If applicable, the State Opioid Treatment Authority.

(2) The notice provided shall include the organization’s written plan for:

(a) Discontinuation of operations, including relevant dates;

(b) Informing program participants or guardians of the planned discontinuation of services;

(c) Informing program participants or guardians of other behavioral health service options;

(d) Transitioning program participants to other behavioral health services;

(e) Storing and protecting all records after the discontinuation of operations for a period of at least 7 years; and

(f) Notifying employees, contractors, and consultants of its discontinuation of operations.

(3) Within 20 business days from receipt of the organization’s notification of intention to discontinue program or licensed service operations, the Administration shall:

(a) Notify the organization in writing whether the organization’s written discontinuation plan is acceptable; and

(b) Either:

(i) Approve final closure; or

(ii) If the organization’s plan is unacceptable, meet with the organization and the appropriate local authority to make a plan that protects the health, safety, and welfare of program participants.

(4) Until the Administration approves final closure, the organization shall:

(a) Provide services as appropriate;

(b) Make best efforts to refer program participants to alternative services to ensure continuation of care; and

(c) Document its efforts to refer program participants to alternative services.

(5) Upon approval by the Administration of the organization’s discontinuation plan, the organization shall implement the discontinuation plan.

(6) At all times during the discontinuation process, the organization shall cooperate with the Administration and the appropriate local authority.

B. Unplanned Discontinuation of Program Operations.

(1) An organization licensed in accordance with this subtitle that experiences an unexpected discontinuation or interruption of services for more than 1 day at any licensed program site, whether temporary or permanent, shall immediately, but no longer than 24 hours, inform:

(a) Program participants or their guardians via:

(i) Direct communication; and

(ii) Visible signage at the licensed program site;

(b) The Administration;

(c) The appropriate local authority; and

(d) If applicable, the State Opioid Treatment Authority.

(2) The organization, if requested by the Administration or the local authority, shall provide a proposed written emergency plan that includes:

(a) A census of program participants affected by the discontinuation of services;

(b) Types of services affected;

(c) Expected or estimated duration of closure;

(d) How services will be provided in the interim, including any staffing changes;

(e) If applicable, the location where interim services will be provided;

(f) If applicable, a plan to transition program participants to an alternative program or make other arrangements to ensure continuity of services for the individuals;

(g) A plan for storing and protecting all records, ensuring program participant and auditor access upon request; and

(h) A plan for notification of employees, contractors, consultants, and consumers.

(3) In the event of an unplanned discontinuation of program operations, the Administration or its designee may contact program participants to discuss the discontinuation of services and ensure the continuity of care.

(4) Within 7 business days after receipt of the organization’s notification of discontinuation of program operations, the Administration shall:

(a) Notify the organization in writing whether the organization’s written discontinuation plan is acceptable; and

(b) Either:

(i) Approve final discontinuation; or

(ii) If the organization’s plan is unacceptable, meet with the organization and the appropriate local authority, to make a plan that protects the health, safety, and welfare of program participants.

(5) The organization may not discontinue program operations until the Administration approves the discontinuation plan.

(6) At all times during the discontinuation process, the organization shall cooperate with the Administration and the appropriate local authority.

C. Non-Compliance with Discontinuation Requirements.

(1) In the event of a planned discontinuation of services, if an organization fails to comply with §A of this regulation, the Secretary may deny any future application for a license submitted by the organization, its corporate officers, or required staff of the organization.

(2) In the event of an unplanned discontinuation of services, if an organization fails to comply with §B of this regulation, the Secretary may deny any future application for a license submitted by the organization, its corporate officers, or required staff of the organization.

10.63.02 [Programs Required to be Accredited in Order to be Licensed to Provide Community-Based Behavioral Health Services] General Staffing Requirements

Authority: Health-General Article, [§§7.5-204,] §§7.5-204 (a)(2)[8-402, 8-404, 10-901,] and [10-1402] 7.5-402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(2) "Administration" means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed in accordance with this subtitle.

(3) Allied Health Staff.

(a) "Allied health staff" means an individual not licensed in accordance with Health Occupations Title, Annotated Code of Maryland that is utilized by an organization to provide support services or direct care services in the operation of a community-based behavioral health program.

(b) “Allied health staff” includes, but is not limited to:

(i) Rehabilitation workers;

(ii) Direct service staff;

(iii) Non-certified peer recovery specialists;

(iv) Community health workers;

(v) Health educators;

(vi) Counselor aides; and

(vii) Group living workers.

(4) "Applicant" means the legally authorized individual or entity submitting an application for licensure.

(5) "Behavioral health services" means prevention, screening, early intervention, treatment, recovery, support, wraparound, and rehabilitation services for individuals with substance-related disorders, addictive disorders, mental disorders, or a combination of these disorders.

(6) "Business day" means any day except Saturday, Sunday, or a State holiday.

(7) "Community-based" means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(8) Corporate Officers.

(a) “Corporate officers” means the managing employees or other individuals responsible for the conduct of the affairs of the organization inclusive of the organization’s controlling board.

(b) “Corporate officers” includes but is not limited to the organization's:

(i) Chief Executive Officer;

(ii) Chief Financial Officer;

(iii) Chief Medical Officer;

(iv) Chief Information Officer;

(v) Corporate Compliance Officer;

(vi) Board members; and

(vii) Other senior officers of the organization.

(9) "Criminal justice information system" has the meaning stated in Criminal Procedure Article, §10-201, Annotated Code of Maryland.

(10) "Critical incident" means an event that impacts the health, safety, or welfare of a program participant or staff.

(11) "Department" means the Maryland Department of Health.

(12) "License" means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(13) "Licensed mental health professional" means a practitioner authorized under Health Occupations Article, Annotated of Code of Maryland, who has specialty in the diagnosis and treatment of mental health, addictive, substance-related, or co-occurring disorders.

(14) Local Authority.

(b) “Local authority” includes the:

(i) Core service agency as defined in Health General Article, §7.5-101(g), Annotated Code of Maryland;

(ii) Local addictions authority as defined in Health General Article, §7.5-101(j), Annotated Code of Maryland; and

(iii) Local behavioral health authority as defined in Health General Article, §7.5-101(k), Annotated Code of Maryland.

(15) "Organization" means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(16) "Participant" means an individual receiving behavioral health services in a community-based program.

(17) "Peer support services" has the meaning stated in Health-General Article, §7.5-101, Annotated Code of Maryland.

(18) "Professional licensure background check" means a background check conducted into an individual's professional status, history, and credentials.

(19) "Program" means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of §B(19)(a)—(c) of this regulation.

(20) "Rap Back Program" has the meaning stated in COMAR 12.15.01.03.

(21) "Residential" means the setting of a community-based program in which program participants both reside and receive behavioral health services.

(22) "Site" means the location where the organization operates the program as detailed on the program’s license.

(23) "Telehealth" means the synchronous delivery of medically necessary services to a participant at an originating site by a distant site provider, through the use of technology-assisted communication in accordance with COMAR 10.09.49.

(24) "Variance" means an alternate method of meeting the intent of a regulation under this subtitle as approved by the Administration.

.02 General Staff Requirements.

A. Supervision of Staff. An organization operating a community-based behavioral health services program shall provide supervision to staff providing direct care services including all requirements of Health Occupations Article, Annotated Code of Maryland.

B. Dedicated Program Staff.

(1) Dedicated program staff are individuals who are employed by an organization to perform duties at a single program site at a time.

(2) Dedicated program staff may perform duties at multiple program sites, but may not actively perform duties for multiple programs simultaneously.

(3) Organizations that require dedicated program staff to perform duties at multiple program sites shall ensure that timekeeping records clearly indicate the program site at which the individual performed duties for each hour worked.

(4) For the purposes of determining if a program meets minimum staffing requirements, an organization may only count the number of hours during which the dedicated program staff performs duties at the program in question.

(5) An organization may not count the hours during which a dedicated program staff performs duties at another program site for the purposes of determining if a program meets minimum staffing requirements, regardless of:

(a) The physical proximity of the different programs;

(b) The amount of services provided by telehealth;

(c) The overlap of services provided by the different programs; and

(d) The overlap in program participants served by the different programs.

C. Organizational Level Staff. Organizational level staff are individuals who are employed by an organization that may perform duties for multiple program sites simultaneously, provided that:

(1) The programs are managed according to uniform organizational policies and procedures applicable to all programs;

(2) All program participant records may be accessed from any program site;

(3) The individual in the position responds to emergencies, in person or via remote video conference, within 1 hour of being notified;

(4) Staff at each licensed program site have direct access to the individual in the position as needed; and

(5) On a routine basis, and as clinically required, the individual in the position provides on-site consultation at each licensed program site to ensure adequate clinical and administrative oversight.

D. Organizations who employ a single individual to perform the duties of multiple positions shall:

(1) When the individual performs an organizational level position and a dedicated program position, consider the individual dedicated program staff for the purposes of determining minimum staffing requirements; and

(2) Meet the requirements of this chapter and any program specific descriptions set forth in this subtitle associated with each of the positions the individual fills.

.03 Vacancy Reporting Requirements.

A. An organization shall follow the requirements of §B of this regulation upon vacancy of any of the following staff:

(1) A corporate officer;

(2) The medical director as specified in Regulation .13 of this chapter;

(3) The program director as specified in Regulation .07 of this chapter;

(4) The clinical director as specified in Regulation .06 of this chapter;

(5) Clinical supervisors as specified in Regulations .09 and .14 of this chapter;

(6) A rehabilitation specialist as specified in Regulation .10 of this chapter; and

(7) Any other required staff as specified within any of the program descriptions set forth in this subtitle.

B. Upon vacancy of any staff specified in §A of this regulation, the organization shall:

(1) Immediately implement a good-faith effort to fill the vacancy;

(2) Seek a variance in accordance with COMAR 10.63.06.10B, if applicable;

(3) Notify the Administration and the appropriate local authority within 40 business days of the vacancy in the manner specified by the Administration; and

(4) Notify the Administration and the appropriate local authority immediately upon hire of the individual filling the vacancy in the manner specified by the Administration to include at minimum the individual’s:

(a) Name;

(b) Credentials, including a copy of any applicable licenses or certifications, and a resume or curriculum vitae; and

(c) Actual start date.

C. Notwithstanding the requirements of §A of this regulation, an organization shall immediately, but in no event longer than 48 hours, report to the Administration any vacancy that causes a significant impact to a licensed program’s operations or the health, safety, or welfare of program participants.

.04 Staff Training and Competency Plans.

A. An organization operating a community-based behavioral health services program shall develop and implement a training plan that covers each staff member which includes at a minimum policies and procedures related to:

(1) Onboarding;

(2) Orientation;

(3) Annual training;

(4) Performance standards; and

(5) Competency development plan.

B. Within 60 business days of hire, at a minimum, all staff shall receive training from the organization in, at minimum, the following:

(1) Role and responsibilities;

(2) Corporate compliance;

(3) Confidentiality and communication with program participants and others, including participant consent;

(4) Building caring and collaborative relationships with program participants;

(5) Setting and maintaining safe boundaries with program participants;

(6) Confidentiality and communication with program participants and others, including participant consent;

(7) Any other training as specified within the program descriptions set forth in this subtitle; and

(8) Any other training required by the organization’s accreditation organization.

C. Staff Training Records. An organization shall maintain all staff training in accordance with the employment records requirements contained in COMAR 09.32.01.06.

.05 Background Checks for All Programs.

A. Criminal Background Checks.

(1) An organization shall, at minimum, perform a criminal background check, at the organization’s expense, for each employee and contractor:

(a) Prior to employment; and

(b) Every 3 years.

(2) The pre-employment criminal background check shall, at minimum, include:

(a) The individual’s criminal history in any state in which they have lived or worked in the past 10 years; and

(b) If their scope of work for the organization includes transporting program participants, the individual’s driving record in any state in which they have lived or worked in the past 10 years.

(3) Any subsequent criminal background checks conducted while the individual is employed by the organization shall, at minimum, include the State, and, if the individual resides out of State, the state in which the individual resides.

(4) Any organization providing licensed behavioral health services to minors shall comply with the criminal background check requirements set forth in Family Law Article, §5-551, Annotated Code of Maryland.

(5) A criminal background check through the Criminal Justice Information System will satisfy the requirements of:

(a) The initial pre-employment criminal background check; or

(b) Any subsequent criminal background checks.

(6) An organization participating in the Department of Public Safety and Correctional Services Rap Back Program is exempt from the requirements of §A(1)(b) of this regulation.

B. Professional Licensure Background Check.

(1) An organization shall perform a professional licensure background check for each employee and contractor who holds professional licensure:

(a) Prior to employment; and

(b) Every 2 years.

(2) Each professional licensure background check shall include the State and any state in which the individual has held professional licensure in the past 10 years.

C. Continuous Monitoring for Exclusion.

(1) Each organization shall continuously monitor the following resources to ensure they are not employing individuals who have been excluded from providing services:

(a) Maryland Medicaid’s sanctioned providers list;

(b) The Department’s Office of the Inspector General’s exclusion list; and

(c) The federal Department of Health and Human Services, Office of the Inspector General’s List of Excluded Individuals/Entities database.

(2) An organization shall, at minimum, check all employees for exclusion in the resources enumerated in §C(1) of this regulation quarterly.

D. Background Check Policy.

(1) An organization shall have a background check policy covering each program it operates regarding the criminal history and professional licensure history of employees and contractors.

(2) The background check policy, at a minimum, shall:

(a) Outline the criteria to be used to determine if an individual with a criminal history can be employed by the organization, including the following considerations:

(i) The age at which the individual committed the crime;

(ii) The circumstances surrounding the crime;

(iii) Any punishment imposed for the crime, including any subsequent court actions regarding that punishment;

(iv) The length of time that has passed since the crime;

(v) Subsequent work history;

(vi) Employment and character references; and

(vii) Other evidence that demonstrates whether the employee, contractor, or volunteer poses a threat to the health or safety of program participants, program staff, or members of the public;

(b) Outline the criteria to be used to determine if an individual with a license not in good standing in the past 10 years can be employed by the organization; and

(c) Require employees and contractors to report the following:

(i) All arrests or pending criminal charges except for minor traffic violations that occur during employment; and

(ii) Any change in professional license or certificate status.

(3) The background check policy may contain exclusionary criteria stricter than required by §E of this regulation, as appropriate, to protect program participants.

E. Exclusionary Criteria.

(1) The organization may not employ an employee or contractor if the organization does not complete the criminal background check and professional licensure check as required by §§A and B of this regulation.

(2) The organization may not employ an employee or contractor if the individual is excluded from providing services by:

(a) Maryland Medicaid;

(b) The Department’s Office of the Inspector General; or

(c) The federal Department of Health and Human Services.

(3) An organization may not employ an employee or contractor if the individual has been convicted at any time of:

(a) Child abuse;

(b) Abuse or neglect of a vulnerable adult; or

(c) Sexual abuse.

F. Documentation Requirements.

(1) An organization shall document the organization’s:

(a) Review of criminal history and professional licensure records of potential employees and contractors;

(b) Decisions regarding the impact of the criminal history or professional licensure history on the employability of each applicant for employment and on each employee and contractor; and

(c) Implementation of the policy required by §D of this regulation.

(2) An organization shall maintain the documentation required by §F(1) of this regulation for 3 years after the individual either:

(a) Is not hired; or

(b) If hired, leaves employment with the organization.

G. An organization seeking to utilize volunteers shall ensure current and prospective volunteers are subject to the background check requirements as described in §§A—F of this regulation.

.06 Clinical Director.

A. A clinical director is an organizational level staff member and may perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

B. A clinical director shall possess, at minimum, the following qualifications:

(1) An active professional behavioral health license at the independent practice level in accordance with the applicable Health Occupations Board; and

(2) At least 5 years of documented experience in human services, 2 years of which include providing administrative or clinical supervision.

C. A clinical director shall:

(1) Be an employee of the organization which operates the program which they direct;

(2) Be available in person at each program site a sufficient number of hours in order to effectively direct the clinical aspects of the program in accordance with §D of this regulation; and

(3) Arrange for an appropriate clinical supervisor in accordance with Health Occupations Article, Annotated Code of Maryland.

D. A clinical director is responsible for the following functions:

(1) Leading and approving the development of clinical program policies and procedures;

(2) Providing clinical supervision and oversight of the clinical quality of the organization;

(3) Managing clinical crises; and

(4) Ensuring the organization follows appropriate discontinuation of service procedures including transition of care in accordance with COMAR 10.63.01.13.

E. A clinical director may be a clinical supervisor in accordance with Health Occupations Article, Annotated Code of Maryland.

.07 Program Director.

A. A program director is an organizational level staff member and may perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

B. A program director shall possess, at minimum, the following qualifications:

(1) A bachelor's degree from an accredited educational institution; and

(2) Five years of documented experience in human services, 2 years of which include providing administrative or clinical supervision.

C. The program director shall:

(1) Be an employee of the organization that operates the program which they direct; and

(2) Be available in person at each program site for a sufficient number of hours in order to effectively direct the program in accordance with §D of this regulation.

D. The program director is responsible for the following functions:

(1) Leading and approving the development of program policies and procedures;

(2) Administrative oversight;

(3) Program supervision and oversight;

(4) Ensuring the implementation and safety of the therapeutic and treatment environment;

(5) Ensuring the organization’s program license is posted in accordance with COMAR 10.63.06.04D; and

(6) Ensuring the organization follows appropriate discontinuation of service procedures including the transition of care in accordance with COMAR 10.63.01.13.

E. The program director may delegate the responsibilities enumerated in §D of this regulation through a formal delegation agreement.

.08 Corporate Compliance Officer.

A. A corporate compliance officer is an organizational level staff member and may perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

B. A corporate compliance officer shall meet all minimum qualifications as set forth by the organization.

C. The corporate compliance officer shall:

(1) Be an employee of the organization that operates the program which they oversee; and

(2) Be available in person at each program site for a sufficient number of hours in order to effectively oversee the program in accordance with §D of this regulation.

D. The corporate compliance officer shall:

(1) Have direct access to the organization’s corporate officers;

(2) Educate the organization on necessary compliance requirements;

(3) Develop and oversee compliance with the corporate compliance plan in accordance with COMAR 10.63.01.05; and

(4) Address noncompliance within the organization and, if necessary, report noncompliance in accordance with COMAR 10.63.01.05C(8).

.09 Licensed Mental Health Professionals and Clinical Supervisors.

A. Licensed Mental Health Professionals.

(1) A licensed mental health professional is dedicated program staff and may not perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

(2) A licensed mental health professional shall possess active licensure in accordance with Health Occupations Article, Annotated Code of Maryland and may include the following:

(a) Psychiatrist;

(b) Licensed psychologist;

(c) Psychiatric nurse practitioner;

(d) Clinical nurse specialist in psychiatric and mental health nursing;

(e) Licensed certified social worker-clinical;

(f) Licensed clinical alcohol and drug counselor;

(g) Licensed clinical marriage and family therapist;

(h) Licensed clinical professional art therapist;

(i) Licensed clinical professional counselor; or

(j) An individual properly supervised under a formal supervision agreement who is either a:

(i) Licensed master social worker;

(ii) Licensed graduate alcohol and drug counselor;

(iii) Licensed graduate marriage and family therapist;

(iv) Licensed graduate professional art therapist;

(v) Licensed graduate professional counselor;

(vi) Licensed certified social worker; or

(vii) Registered psychology associate.

B. Clinical Supervisors.

(1) Clinical supervisors are dedicated program staff and may not perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

(2) A clinical supervisor shall:

(a) Only provide clinical supervision if actively licensed to do so in accordance with Health Occupations Article, Annotated Code of Maryland; and

(b) If providing supervision to alcohol and drug counselors have written approval from the Board of Professional Counselors as required by COMAR 10.58.07.13—.15.

(3) If a clinical supervisor is not an employee of the organization, the clinical supervisor shall execute the following agreements:

(a) A Business Associates Agreement between the clinical supervisor and the organization in accordance with 45 CFR §164.502; and

(b) A formal supervision agreement between the clinical supervisor and the individual they supervise.

C. Clinical Interns. An organization may utilize clinical interns within the scope of service limits established by State law and regulation.

D. An organization may not allow a licensed mental health professional to provide behavioral health services to program participants when the mental health professional is located outside the United States or its territories.

.10 Rehabilitation Specialists.

A. Rehabilitation specialists are dedicated program staff and may not perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

B. A rehabilitation specialist shall, at minimum, have the following qualifications:

(1) Have a minimum of 2 years of direct care experience working with:

(a) Adults that have a serious mental disorder; or

(b) Minors who have serious emotional or behavioral difficulties;

(2) Be licensed or certified as one of the following in accordance with Health Occupations Article, Annotated Code of Maryland:

(a) A licensed mental health professional as defined in this chapter, certified at the independent practice level;

(b) A licensed mental health professional certified at the graduate level, receiving formal, documented supervision, in accordance with licensing board requirements, by a licensed mental health professional who is an employee of the organization;

(c) A licensed mental health professional certified at the graduate level, receiving formal, documented supervision, in accordance with licensing board requirements, by a licensed mental health professional who has a Business Associate Agreement with the organization in accordance with 45 CFR §164.502;

(d) A licensed occupational therapist;

(e) A registered nurse who:

(i) Is licensed and in good standing holds a psychiatric mental health nursing certification in accordance with the American Nurses Credentialing Center; or

(ii) Has, at minimum, a bachelor’s degree in social work, counseling, rehabilitation, psychology, nursing, or a related field; or

(f) A master’s prepared rehabilitation counselor certified in the practice of rehabilitation counseling by the Commission on Rehabilitation Counselor Certification.

C. A rehabilitation specialist shall:

(1) Be an employee of the organization that operates the program; and

(2) Be available in person at each program site for a sufficient number of hours in order to effectively direct the program in accordance with §D of this regulation.

D. Rehabilitation specialists shall perform the following duties:

(1) Patient assessments;

(2) Person-centered treatment planning;

(3) Psycho-social skill training;

(4) Clinical documentation; and

(5) Other services as informed by the needs of the program participant.

.11 Certified Peer Recovery Specialists.

A. Certified peer recovery specialists are dedicated program staff and may not perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

B. An organization shall ensure that a certified peer recovery specialist has the following qualifications:

(1) A high school diploma or high school equivalency certificate; and

(2) A current certification as a peer recovery specialist from the Board approved by the Department.

C. A certified peer recovery specialist shall adhere to all requirements of the Board, including at a minimum:

(1) Formal training and education of the knowledge, skills and abilities in each of the four domains identified by the Board; and

(2) Adherence to the Ethics Code of Conduct, Principles and Service Guidelines established by the Board.

D. A certified peer recovery specialist may not perform any clinical treatment services or functions unless otherwise licensed in accordance with Health Occupations Article, Annotated Code of Maryland.

.12 Allied Health Staff.

A. An organization operating a community-based behavioral health services program may utilize allied health staff in the operation of the program to provide:

(1) Support services; or

(2) Direct care services which are not within the scope of practice of a licensed clinical professional in accordance with Health Occupations Title, Annotated Code of Maryland.

B. Qualifications. An organization shall have policies and procedures for the employment of allied health staff which specifies:

(1) Minimum qualifications; and

(2) Any prevailing professional standards in accordance with the program descriptions set forth in this subtitle.

C. A corporate officer may not serve as allied health staff in the course of their regular duties.

.13 Medical Directors.

A. Medical directors are dedicated program staff and may not perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

B. Effective January 1, 2026, the medical director of a program shall:

(1) Be licensed in the State as required by Health Occupations Article, §14-301, Annotated Code of Maryland; and

(2) Be an employee of the organization which operates the program which they direct.

C. The medical director, either directly or through formal delegation, shall:

(1) Approve and regularly review the program’s:

(a) Admission criteria;

(b) Discharge criteria; and

(c) Medical policies, procedures, and protocols;

(2) Direct patient care;

(3) Ensure the adequacy of individualized treatment plans;

(4) Ensure daily medical coverage to meet program participant needs;

(5) Determine the credentials required of other licensed clinical staff who serve the program;

(6) Monitor the care delivered by other staff who serve the program;

(7) Review all critical incidents; and

(8) Oversee the quality of care delivered by all programs for which the individual is serving as medical director.

D. In addition to the requirements of this regulation, a medical director shall meet any applicable additional program specific qualifications or requirements set forth in this subtitle.

.14 Substance Use Disorder Program Specific Staff.

A. Substance Related Disorder Clinical Supervisor.

(1) Substance related disorder clinical supervisors are dedicated program staff and may not perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

(2) A substance related disorder clinical supervisor shall have, at minimum, the following qualifications:

(a) Be employed as a clinical supervisor before October 1, 2002 or, at minimum, licensed as one of the following:

(i) A licensed clinical professional counselor;

(ii) A licensed certified social worker—clinical; or

(iii) A licensed alcohol and drug counselor; and

(b) Be approved to supervise from the Board of Professional Counselors and Therapists as required by COMAR 10.58.07.13—.15.

(3) A clinical supervisor shall provide, in person or via audio visual teleconference, supervision to staff, maintaining a staff to supervisor ratio of no greater than one supervisor to 15 staff.

(4) A Certified Associate Alcohol and Drug Counselor who is approved by the Board of Professional Counselors and Therapists to supervise shall themselves be supervised by a Board approved supervisor in accordance with COMAR 10.58.07.07.

(5) A clinical supervisor may carry a caseload so long as the supervisor’s caseload does not impede the clinical supervisor’s ability to supervise.

B. Facility Coordinator.

(1) Facility coordinators for residential substance use disorder programs are dedicated program staff and may not perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

(2) A facility coordinator shall have, at minimum, the following qualifications:

(a) A high school diploma or high school equivalency certificate; and

(b) Two years of experience as an allied health staff member in a substance related disorder treatment program.

(3) The responsibilities of a facility coordinator include:

(a) Overseeing the daily operations of the licensed program site; and

(b) Ensuring the program site is sufficiently maintained to meet the needs of the program.

C. Substance Related Disorder Clinical Staff.

(1) Substance related disorder clinical staff are dedicated program staff and may not perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

(2) Substance related disorder clinical staff shall, at minimum, be:

(a) Licensed or certified as an alcohol and drug counselor by the Board of Professional Counselors and Therapists; or

(b) Licensed, certified, or permitted under Health Occupations Article, Annotated Code of Maryland to provide substance abuse treatment.

(3) Substance related disorder clinical staff are responsible for the following:

(a) Providing substance related disorder assessment and treatment services;

(b) Documenting services accurately;

(c) Maintaining confidentiality;

(d) Ensuring services are provided in accordance with applicable supervision requirements; and

(e) Ensuring program participant rights are respected.

10.63.06 [Application and] Licensure Process

Authority: Health-General Article, [§§7.5-204,] §§7.5-204 (a)(2)[8-402, 8-404,] and [10-901] 7.5-402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(2) "Accreditation" means the approval granted to a program by an accreditation organization.

(3) "Accreditation-based license" means a license which requires that the organization be accredited by an approved accreditation organization.

(4) "Administration" means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed in accordance with this subtitle.

(5) "Administrative withdrawal" means the Administration's cancellation of an organization's application for licensure.

(6) "Agreement to cooperate" means a written agreement between an organization operating a program and the appropriate local authority that provides for coordination and cooperation in carrying out behavioral health activities in a given jurisdiction.

(7) "Applicant" means the legally authorized individual or entity submitting an application for licensure.

(8) "Behavioral health services" means prevention, screening, early intervention, treatment, recovery, support, wraparound, and rehabilitation services for individuals with substance-related disorders, addictive disorders, mental disorders, or a combination of these disorders.

(9) "Business day" means any day except Saturday, Sunday, or a State holiday.

(10) "Community-based" means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(11) Corporate Officers.

(a) “Corporate officers” means the managing employees or other individuals responsible for the conduct of the affairs of the organization inclusive of the organization’s controlling board.

(b) “Corporate officers” includes but is not limited to the organization's:

(i) Chief Executive Officer;

(ii) Chief Financial Officer;

(iii) Chief Medical Officer;

(iv) Chief Information Officer;

(v) Corporate Compliance Officer;

(vi) Board members; and

(vii) Other senior officers of the organization.

(12) "Corrective Action" means specific actions undertaken by an organization to address a violation of any local, state, or federal law or regulation.

(13) "Deficiency" means a failure to meet an accreditation, licensure, or certification standard, or a relevant federal, State, or local ordinance, law, regulation, or building code, as applicable.

(14) "Department" means the Maryland Department of Health.

(15) "Jurisdiction" means Baltimore City or one of the 23 counties in the State.

(16) "License" means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(17) Local Authority.

(b) “Local authority” includes the:

(i) Core service agency as defined in Health General Article, §7.5-101(g), Annotated Code of Maryland;

(ii) Local addictions authority as defined in Health General Article, §7.5-101(j), Annotated Code of Maryland; and

(iii) Local behavioral health authority as defined in Health General Article, §7.5-101(k), Annotated Code of Maryland.

(18) "Organization" means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(19) "Participant" means an individual receiving behavioral health services in a community-based program.

(20) "Plan of correction" means an organization's written plan of corrective actions to address program deficiencies.

(21) "Program" means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of §B.(21)(a)—(c) of this regulation.

(22) "Resident agent" has the meaning stated in Corporations and Associations Article, §1-101, Annotated Code of Maryland.

(23) "Residential" means the setting of a community-based program in which program participants both reside and receive behavioral health services.

(24) "Secretary" means the Secretary of the Maryland Department of Health or their designee.

(25) "Site" means the location where the organization operates the program as detailed on the program’s license.

(26) "Variance" means an alternate method of meeting the intent of a regulation under this subtitle as approved by the Administration.

.02 License Application Process for All Community-Based Behavioral Health Programs.

A. An organization seeking to operate a program to provide community-based behavioral health services shall submit an application for licensure to the Administration or its designee in the manner specified by the Administration.

B. The application shall, at minimum, provide the following information:

(1) The services the organization intends to provide at the program site;

(2) Verification of the organization’s compliance with all applicable requirements for the program under this subtitle; and

(3) Attestation of the organization’s compliance with relevant federal, State, or local ordinances, laws, regulations, and orders governing the program.

C. The applicant shall report the following information regarding the organization seeking licensure:

(1) A listing of all individuals or entities with an ownership stake in the organization;

(2) A listing of the names and contact information of all corporate officers of the organization, including board members;

(3) Contact information including:

(a) The name and email address of a designated point of contact;

(b) A mailing address; and

(c) The contact information for the organization’s resident agent; and

(4) A copy of any program license or certification currently or previously held by the organization.

D. The applicant shall complete a disclosure form in the manner specified by the Administration that discloses, at minimum, the following information for individuals or entities with an ownership stake, corporate officers, key staff, or any additional individuals specified by the Administration:

(1) Any deficiencies or compliance violations issued by an accreditation organization or licensing entity;

(2) Any suspension, revocation, or termination of a license;

(3) Any criminal convictions other than minor traffic violations;

(4) Any settlements with the Department's Office of the Inspector General; and

(5) Any money owed to the Department.

E. The applicant shall include with the application all documentation required in §§B—D of this regulation and any additional program specific documentation as set forth in the chapter of this subtitle outlining the program description.

F. Additional Application Requirements for Organizations Requiring Accreditation.

(1) An applicant applying for an accreditation-based license shall submit the following with the organization's application:

(a) The program's most recent behavioral health accreditation survey report;

(b) The final letter or certificate issuing accreditation to the organization; and

(c) The findings, reports, and program improvement plans arising from any accreditation survey or decision by any behavioral health accreditation organization during the previous 3 years.

(2) An organization currently operating a program with a plan of correction approved by an approved accreditation organization shall provide:

(a) A copy of the plan of correction; and

(b) Documentation demonstrating that the organization’s program currently complies with the plan of correction.

G. As part of the license application process, the Administration may request that an organization submit to an inspection of the program site prior to issuing a license.

.03 Documentation to Accompany License Application.

A. Applicants shall include the following documentation with their application for licensure to operate a program to provide community-based behavioral health services:

(1) A copy of the agreement to cooperate between the organization and the appropriate local authority as described in COMAR 10.63.01.10;

(2) Copies of all applicable permits required by local jurisdictions and the Administration, including, at a minimum:

(a) Fire permits; and

(b) Use and occupancy permits;

(3) A copy of the organization’s current by-laws and articles of incorporation;

(4) A copy of the organization’s certificate of status from the State Department of Assessments and Taxation, verifying the organization is in good standing, issued within the current tax year of the application;

(5) A copy of the organizational chart for the organization and program showing the supervisory structure which includes the names, roles, professional titles, and credentials of all required management staff and other required staff;

(6) Documented verification that the program site is:

(a) Owned or leased by the organization;

(b) Under the sole control of the organization; and

(c) Not prohibited from providing behavioral health services on the site;

(7) A copy of the organization’s business plan and 1 year operating budget; and

(8) A copy of the organization’s plan for continuity of operations in the event of:

(9) Loss of key staff;

(a) Loss of ability to provide services for any reason; or

(b) Loss of facility.

B. Any organization currently operating a community-based behavioral health program with a plan of correction approved by the Administration or local authority shall provide documentation demonstrating the organization’s compliance with the plan of correction.

C. Any organization seeking licensure for a program that will prepare or serve food shall provide a copy of its commercial kitchen license for the program or the caterer that is providing food.

D. Additional Documentation.

(1) The Administration may determine additional documentation is necessary to evaluate a license application.

(2) Upon request, the organization shall provide any additional documentation requested by the Administration.

.04 Issuance of License.

A. The Administration or its designee shall review all completed applications for licensure.

B. If the Administration or its designee determines that the application meets the requirements of this subtitle to provide community-based behavioral health services, the Secretary shall issue a license to the organization to operate a program to provide community-based behavioral health services that specifies the:

(1) Programs that the applicant is licensed to provide, including the addresses of all licensed program sites;

(2) Duration of the licensure period:

(3) If applicable, the name of the accreditation organization; and

(4) Date of issue.

C. Notifications of Licensure.

(1) The Administration shall notify the applicable local authority when an organization has been issued a license to operate a program to provide community-behavioral health services.

(2) The Administration shall post a license listing on its website that describes the following for each licensed program:

(a) The name of the organization operating the program;

(b) The licensed program type;

(c) The effective dates of licensure; and

(d) Contact information:

(i) For non-residential programs, the licensed program site address; or

(ii) For residential programs, the contact address which is provided by the organization.

D. Each organization shall ensure that the license is posted in a public area at the licensed program site.

.05 Duration of License.

A. A license is effective on the date issued as it appears on the license and remains in effect for the duration of the license period.

B. Unless modified by the Secretary for good cause, the license period is:

(1) For an accreditation-based license, the duration of the accreditation period plus 3 months; or

(2) For all other licenses, the period established by the Administration at the time the license was issued, which is not to exceed 3 years.

C. The Secretary may, at the Secretary’s discretion and with notice to the organization, issue an extension or modify a license expiration date.

.06 License Renewal.

A. An organization seeking to continue operating a program beyond the program’s current license period shall submit a new application in accordance with Regulation .02 of this chapter.

B. The application shall be received by the Administration or its designee at least 40 business days, but no more than 120 business days, before the expiration of the organization's current license.

C. Failure to Submit a Timely Application.

(1) If the organization does not submit a new application in a timely manner, as described in §B of this regulation, the Secretary may suspend the organization’s license at the end of the current license period.

(2) If an organization’s license is suspended, the organization shall proceed with enacting an unplanned discontinuation of services as outlined in COMAR 10.63.01.13.

D. License Renewal for Organizations with Sanctions.

(1) For any organization that is subject to a plan of correction or sanctions under COMAR 10.63.09 the organization may request a temporary license extension to address any deficiencies at least 40 business days prior to the expiration of the organization’s current license.

(2) The Secretary may grant a temporary license extension, not to exceed 60 business days, to allow the program to perform any corrective actions to address deficiencies or sanctions.

(3) An organization operating under a temporarily extended license may submit a new license application in accordance with §A of this regulation once they have addressed all deficiencies or sanctions.

(4) The Secretary may deny a license for any organization that has:

(a) Failed to address program deficiencies which present a risk to the health and safety of program participants; or

(b) Failed to comply with a plan of correction, directed plan of correction, or sanction in accordance with COMAR 10.63.09.

E. The effective date and duration period for the license is established in accordance with Regulation .05 of this chapter.

F. An organization’s previously issued license expires the day prior to the effective date of the newly issued license.

.07 Administrative Withdrawal.

A. The Administration may withdraw an application for licensure submitted to the Administration when:

(1) The Administration cannot make a determination on the application due to incomplete information or missing required documentation;

(2) The Administration has attempted to contact the applicant using the contact information provided in accordance with Regulation .02C(3) of this chapter to complete the application or obtain the missing documentation; and

(3) The applicant has not supplied the Administration with completed information within 30 business days of notification that the application is incomplete or that additional documentation is required.

B. The Administration shall notify the organization when an application for licensure has been administratively withdrawn.

C. An applicant whose application is withdrawn in accordance with this regulation may submit a new application in accordance with Regulation .02 of this chapter.

D. An applicant whose application is withdrawn in accordance with this regulation may not submit more than two applications for the same program in one calendar year.

E. An administrative withdrawal of an application is not a denial as described in Regulation .08 of this chapter and may not be appealed in accordance with COMAR 10.63.09.09.

.08 Denial of License to Provide Community-Based Behavioral Health Services.

A. The Secretary may deny a license to any applicant that does not sufficiently demonstrate its ability to meet the requirements of this subtitle to provide community-based behavioral health services.

B. When determining the applicant’s capacity to operate a program in accordance with the requirements of this subtitle, the Secretary shall consider, at minimum, the following:

(1) If the applicant or any of the individuals listed under COMAR 10.63.06.02C(1) and (2) have:

(a) Had a previous license revoked by the Administration or other licensing authority, or has surrendered or defaulted on a license for disciplinary related reasons; or

(b) Discontinued operations of another program without complying with the requirements of COMAR 10.63.01.13;

(2) If the information the applicant disclosed in accordance with COMAR 10.63.06.02D would indicate an inability of the applicant to safely operate a program;

(3) Any loss or denial of accreditation status by an accreditation organization;

(4) Any outstanding debts or financial obligations of the organization; and

(5) Any criminal convictions of the applicant or any of the individuals listed under COMAR 10.63.06.02C(1) and (2), in accordance with §D of this regulation.

C. The Secretary shall deny any application that meets one or more of the following criteria:

(1) The applicant failed to disclose information in accordance with COMAR 10.63.06.02D;

(2) The applicant intentionally falsified information provided in connection with any application to the Department;

(3) A continuing course of conduct of material non-compliance with applicable statutes and regulations; or

(4) A pattern of submission of false information to the State or its designees in order to:

(a) Obtain medical necessity authorizations for service; or

(b) Obtain payment.

D. In making a determination about a license application from an applicant with a criminal record, the Secretary shall consider the following factors:

(1) The age at which the crime was committed;

(2) The circumstances surrounding the crime;

(3) The length of time that has passed since the crime;

(4) Subsequent work history;

(5) Employment and character references; and

(6) Other evidence that demonstrates whether the applicant poses a threat to the health or safety of program participants.

E. If the Secretary denies licensure, the Administration shall give written notice of the denial to the applicant.

F. The notice of the denial of an application for a license shall include:

(1) The reason for the denial of licensure;

(2) The effective date of the denial; and

(3) Notice that the program has a right to a hearing in accordance with COMAR 10.63.09.09.

.09 License Modification.

A. An organization shall submit a written request to the Administration, in the manner required by the Administration, before adding or closing a program site, or otherwise altering the services provided at a licensed program site.

B. A written request for program modification shall, at minimum, include the following:

(1) An application for program modification in the manner required by the Administration;

(2) Documentation indicating that the organization has notified the appropriate local authority of the proposed program modification;

(3) Documentation indicating that the organization has notified any program participants of the proposed change in program site; and

(4) If the program operates in accordance with an accreditation-based license, documentation indicating that the organization has notified the appropriate accreditation organization of the proposed program modification.

C. Prior to approval for any modification described in this regulation, an organization’s program site may be inspected by the Administration or its designee.

D. Relocation.

(1) A license modification does not include the relocation of a licensed program to a new program site.

(2) An organization seeking to relocate operations of a licensed program to a new program site shall:

(a) Initiate a discontinuation of program operations in accordance with COMAR 10.63.01.13; and

(b) Submit a new license application in accordance with Regulation .02 of this chapter.

E. If an organization adds or closes a program site, or otherwise alters the services provided at a licensed program site without prior approval from the Administration, the Secretary may suspend the organization's license in accordance with COMAR 10.63.09.05.

.10 Variances.

A. An organization shall request a variance from the Administration if:

(1) The organization is unable to meet the requirements of any regulation under this subtitle for any program it operates; and

(2) The organization intends to request the Administration to temporarily exempt an organization from the requirements of any regulation under this subtitle.

B. An organization seeking a variance shall request the variance from the Administration within 40 business days unless the timeline for reporting the occurrence to the Administration as required by this subtitle is sooner.

C. The Administration may grant a variance to any organization operating a program providing community-based behavioral health services licensed in accordance with this chapter for any regulation under this subtitle.

D. The organization shall submit a written request for a variance in the manner determined by the Administration.

E. Granting Variances.

(1) The Administration shall review completed variance requests and determine if the intent of the regulation to which a variance is sought is met by the alternative proposed by the organization.

(2) The Administration shall respond to all variance requests with a written notice that:

(a) Provides the organization with the decision on the request for a variance, including the justification the Administration used to reach the decision;

(b) Provides the timeframe for which the variance is granted; and

(c) Is shared with the relevant local authority.

F. A variance is applicable to a single licensed program site and is non-transferable.

G. Failure to comply with any conditions under which the variance is granted may result in revocation of the variance.

H The Administration may not grant a variance:

(1) That would endanger the health or safety of the individuals served;

(2) For any accreditation standard; or

(3) For any State, local, and federal laws and regulations other than those governed under this subtitle.

I. Variances are granted at the Administration’s discretion and may not be appealed.

10.63.09 Corrective Actions and Sanctions

Authority: Health-General Article, §§7.5-205(a)(2), 7.5-402, and 19-333—19-339 Annotated Code of Maryland.

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(2) "Accreditation" means the approval granted to a program by an accreditation organization.

(3) "Accreditation-based license" means a license which requires that the organization be accredited by an approved accreditation organization.

(4) "Administration" means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed in accordance with this subtitle.

(6) "Business day" means any day except Saturday, Sunday, or a State holiday.

(7) "Community-based" means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(8) "Corrective Action" means specific actions undertaken by an organization to address a violation of any local, state, or federal law or regulation.

(9) "Deficiency" means a failure to meet an accreditation, licensure, or certification standard, or a relevant federal, State, or local ordinance, law, regulation, or building code, as applicable.

(10) "Department" means the Maryland Department of Health.

(11) "Guardian" has the meaning stated in Estates and Trusts Article, §13-101, Annotated Code of Maryland.

(12) "License" means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(13) Local Authority.

(b) “Local authority” includes the:

(i) Core service agency as defined in Health General Article, §7.5-101(g), Annotated Code of Maryland;

(ii) Local addictions authority as defined in Health General Article, §7.5-101(j), Annotated Code of Maryland; and

(iii) Local behavioral health authority as defined in Health General Article, §7.5-101(k), Annotated Code of Maryland.

(14) Material and Egregious Violation.

(a) “Material and egregious violation” means any course of conduct, including a single incident, that may cause a program, individual, or organization to fail to comply with any statutory, regulatory, or contractual requirement.

(b) “Material and egregious violation” includes but is not limited to:

(i) Fraudulent or other behavior which influences or may influence the payment or receipt of money or other property;

(ii) Practices which affect or may affect the health or safety of any individual; or

(iii) Practices which violate or may violate participant rights.

(15) "Notice of deficiencies" means the notice provided by the Administration to an organization regarding any deficiencies, including a violation of any local, State, or federal law or regulation.

(16) "Organization" means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(17) "Participant" means an individual receiving behavioral health services in a community-based program.

(18) "Plain language" means language which is easily understandable by program participants and takes into account the various levels of education and understanding of the population.

(19) "Plan of Correction" means an organization's written plan of corrective actions to address program deficiencies.

(20) "Program" means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of §B.(20)(a)—(c)of this regulation .

(21) "Secretary" means the Secretary of the Maryland Department of Health or their designee.

(22) "Site" means the location where the organization operates the program as detailed on the program’s license.

(23) "Summary suspension" means the indefinite suspension of an organization's license taken if the Secretary believes emergency action is necessary to protect the public health, safety, or welfare.

.02 Notice of Deficiencies.

A. If the Administration intends to take action after a determination that an organization licensed to operate a program that provides community-based behavioral health services has violated any provision of this subtitle, including any material and egregious violation of local, State, or federal law or regulation or any accreditation standard, the Administration shall provide the organization with a notice of deficiencies.

B. The Administration’s notice of deficiencies provided to the organization shall include:

(1) A citation to each statute, regulation, or ordinance violated;

(2) The basis for determining the violation; and

(3) Any intermediate sanctions imposed due to the deficiencies.

C. Plan of Correction.

(1) The organization shall submit a plan of correction to the Administration within 10 business days of receipt of the notice of deficiencies, stating:

(a) The corrective action which will be undertaken to address the deficiency;

(b) The individuals in the organization responsible for the corrective action;

(c) The timeline for the corrective action, including a date of resolution; and

(d) How a recurrence will be prevented.

(2) If the Administration determines the nature of the deficiency warrants a more immediate response, the Administration may require that the plan of correction be submitted sooner than 10 business days after receipt of the notice of deficiencies

(3) The Administration may grant an extension, not to exceed 20 business days, for the submission of the plan of correction.

D. Notification Requirements. If the Administration issues a notice of deficiencies to an organization in accordance with §A of this regulation, the organization shall, within 10 business days of receipt of the notice:

(1) Provide program participants or their guardians with a written plain language summary of the notice of deficiencies;

(2) Provide the Administration with a copy of the notice which was provided to program participants; and

(3) If applicable, provide a copy of the notice of deficiencies to the organization’s accreditation organization.

.03 Directed Plan of Correction.

A. If the Administration determines that an organization licensed to operate a program that provides community-based behavioral health services has violated any provision of this subtitle, including any material and egregious violation of local, State, or federal law or regulation, the Administration may impose a directed plan of correction on the organization, in addition to any intermediate sanctions imposed in accordance with Regulation .04 of this chapter.

B. A directed plan of correction may include the following:

(1) Mandated staffing patterns which may specify the number of personnel and personnel qualifications;

(2) Imposition of a site monitor, by which the Administration, or its designee, maintains an ongoing physical presence to provide assistance and evaluate the extent of the organization’s progress in correcting violations;

(3) Submission of reports at the frequency stated by the Administration outlining the organization’s progress in correcting violations; or

(4) Other requirements at the discretion of the Administration to ensure the health, safety, or welfare of program participants.

C. Termination of Directed Plan of Correction. A directed plan of correction may be terminated when:

(1) All conditions of the directed plan of correction are met at the satisfaction of the Administration; or

(2) The Administration determines that progressive disciplinary action is warranted in accordance with Regulations .04–.06 of this chapter and revokes or amends the directed plan of correction.

D. Notification Requirements. If the Administration issues a directed plan of correction to an organization in accordance with §A of this regulation, the organization shall, within 10 business days of receipt of the directed plan of correction:

(1) Provide program participants or their guardians with a written plain language summary of the directed plan of correction;

(2) Provide the Administration with proof of the notice which was provided to program participants; and

(3) If applicable, provide notice of the directed plan of correction to the organization’s accreditation organization.

.04 Intermediate Sanctions.

A. If the Administration determines that an organization licensed to operate a program that provides community-based behavioral health services has violated any provision of this subtitle, including any material and egregious violation of local, State, or federal law or regulation, the Administration may take one or more of the following actions as an intermediate sanction:

(1) Prohibit the organization from providing community-based behavioral health services to any additional individuals not currently receiving services with the organization's licensed program;

(2) Require the organization to reduce the number of program participants currently receiving behavioral health services;

(3) Restrict the organization’s operated program to specified behavioral health services;

(4) Require the organization or any of its staff to receive mandatory training in identified areas within specific timeframes at the organization’s expense;

(5) Require the organization to use the services of an Administration approved consultant at the organization’s expense;

(6) Require the establishment of an escrow account that shall be utilized for specific, identified purposes at the direction of the Administration;

(7) Impose a civil money penalty in accordance with COMAR 10.63.08; or

(8) Require the organization to take any other intermediate action determined necessary by the Administration.

B. The Administration may impose an intermediate sanction in lieu of or in addition to:

(1) A notice of deficiencies in accordance with Regulation .02 of this chapter; or

(2) A directed plan of correction in accordance with Regulation .03 of this chapter.

C. Notification Requirements. If the Administration issues a directed plan of correction to an organization in accordance with §A of this regulation, the organization shall, within 10 business days of receipt of the notice of the intermediate sanction:

(1) Provide program participants or their guardians with a written plain language summary of the intermediate sanction;

(2) Provide the Administration with a copy of the notice which was provided to program participants; and

(3) If applicable, provide notice of the intermediate sanction to the organization’s accreditation organization.

D. If an intermediate sanction requires a program to discontinue services to current or new program participants, an organization shall discontinue operations in accordance with COMAR 10.63.01.13B.

.05 Summary Suspension.

A. The Secretary may order a summary suspension of an organization’s license to operate a program providing community-based behavioral health services if:

(1) The organization violated any provision of this subtitle, including any material and egregious violation of local, State, or federal law or regulation; and

(2) The public health, safety, or welfare imperative requires emergency action.

B. If the Secretary summarily suspends an organization’s license to operate a program providing community-based behavioral health services, the organization shall immediately, but no greater than 24 hours after receipt:

(1) Stop providing services to program participants;

(2) Discontinue any enrollment of any new program participants;

(3) Follow the requirements for an unplanned discontinuation of program operations as outlined in COMAR 10.63.01.13B; and

(4) Cooperate with the Administration and local authority regarding any necessary coordination of care.

C. Following the summary suspension of the license of the organization, the Administration shall follow the requirements of State Government Article, §10-226, Annotated Code of Maryland.

D. The organization may request a hearing on the summary suspension in accordance with Regulation .09 of this chapter.

.06 License Revocation.

B. If the Administration determines that the organization has failed to adhere to a plan of correction or sanction imposed under Regulations .02—.04 of this chapter, the Secretary may revoke the license.

C. The Secretary shall revoke the license of any organization whose accreditation is terminated, not renewed, or otherwise lost.

D. An organization whose license is revoked may not provide community-based behavioral health services which were covered under the revoked license.

E. If the Secretary revokes a license under this chapter, the Administration shall give written notice of the revocation to the organization.

F. An organization may appeal a revocation in accordance with Regulation .09 of this chapter.

G. The notice of the revocation shall include:

(1) The program site, license number, and program which is being revoked;

(2) The facts that warrant the revocation of licensure;

(3) Notice that the organization has a right to a hearing in accordance with Regulation .09 of this chapter; and

(4) The date upon which the program must cease providing services.

H. Notification Requirements. If the Secretary revokes an organization’s license to operate a community-based behavioral health program in accordance with §A of this regulation, the organization shall, within 24 hours of the notice of revocation:

(1) Provide program participants or their guardians with a written plain language notice of the revocation;

(2) Provide the Administration with proof of the notice which was provided to program participants; and

(3) If applicable, provide notice of the revocation to the organization’s accreditation organization.

I. If the Secretary revokes an organization’s license to operate a program providing community-based behavioral health services, the organization shall, by the termination date specified in the notice:

(1) Stop providing services to program participants;

(2) Discontinue enrollment of any new program participants; and

(3) Proceed with an unplanned discontinuation of program operations in accordance with the requirements of COMAR 10.63.01.13B.

.07 Settlement Agreement.

A. An organization that is licensed to operate a program that provides community-based behavioral health services that has violated a requirement of this subtitle may enter into a settlement agreement with the Department.

B. A settlement agreement between an organization and the Department shall be approved by the Secretary.

C. A settlement agreement is considered a public document and may be disseminated in accordance with General Provisions Article, Title 4, Annotated Code of Maryland.

D. Notification Requirements. Upon execution of a settlement agreement with the Department, the organization shall, within 10 business days of settlement:

(1) Provide program participants or their guardians with a written plain language summary of the settlement agreement;

(2) Provide the Administration with proof of the notice which was provided to program participants;

(3) If applicable, provide notice of the settlement to the organization’s accreditation organization; and

(4) Post the settlement agreement:

(a) In a public location at the licensed program site; and

(b) On the program’s website.

.08 Initiation of Receivership.

The Secretary may take action to initiate receivership of an organization licensed to operate a program that provides community-based behavioral health services in accordance with the requirements outlined in Health-General Article, §§19-333—19-339, Annotated Code of Maryland.

.09 Right to a Hearing on Proposed Sanctions.

An organization licensed to operate a program that provides community-based behavioral health services in accordance with COMAR 10.63.06 which is aggrieved by any of the following actions may appeal the determination by filing a request for an administrative hearing in accordance with Regulation .10 of this chapter:

A. The denial of an application for a license under COMAR 10.63.06.08;

B. The summary suspension of a license in accordance with Regulation .05 of this chapter;

C. The denial of a request for a modification of a license in accordance with COMAR 10.63.06.09;

D The denial of a request to discontinue program operations in accordance with COMAR 10.63.01.13;

E. The revocation of a license for any reason other than loss of accreditation in accordance with Regulation .06 of this chapter;

F. The imposition of an intermediate sanction in accordance with Regulation .04 of this chapter;

G. The imposition of a civil money penalty in accordance with COMAR 10.63.08; or

H. The suspension of a license in accordance with COMAR 10.63.06.06.

.10 Hearing Procedures.

A. If the Secretary, Administration, or Department proposes to take an action listed in Regulation .09A—H of this chapter, the Administration shall deliver a written notice of the proposed action to the organization’s program director for the community-based behavioral health program in accordance with the provisions of COMAR 10.01.03.08.

B. Within 10 business days after receipt of the notice of the proposed action, the organization shall submit to the Administration, at the address identified in the notice provided in §A of this regulation, a written request for a hearing.

C. The organization’s request for a hearing shall comply with the provisions of COMAR 10.01.03.06.

D. If the organization does not submit to the Administration a hearing request that is postmarked within 10 business days after the date of the notice provided in §A of this regulation:

(1) The organization’s right to a hearing on the action is waived; and

(2) The Administration’s action shall become final.

E. The Administration may offer the program the opportunity for an informal case resolution conference to attempt to resolve all or some of the deficiencies listed in the notice provided in accordance with Regulation .02 of this chapter.

F. If the organization submits a request for a hearing on a summary suspension in accordance with Regulation .05 of this chapter, the hearing shall take place in accordance with the requirements of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.

RYAN B. MORAN, DRPH, MHSA

Acting Secretary of Health

Title 13A
STATE BOARD OF EDUCATION

Subtitle 12 EDUCATOR LICENSURE

13A.12.05 Administrators and Supervisors

Authority: Education Article, §§2-205, 2-303(g), 6-701—6-708, 8-3A-03 and 8-701—8-708, Annotated Code of Maryland

Notice of Proposed Action

[25-055-P]

The State Board of Education proposes to repeal existing Regulation .05 and adopt new Regulation .05 under COMAR 13A.12.05 Administrators and Supervisors. This action was considered by the State Board of Education at its meeting on February 25, 2025.

Statement of Purpose

The purpose of this action is to repeal and replace the licensure requirements for principals, assistant principals, and supervisors of instruction. The new regulations expand the pathways to licensure and modify the specific courses required for those who earn a licensure outside of an administrator preparation program.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Kelly Meadows, Assistant State Superintendent, Maryland State Department of Education, Division of Educator Effectiveness, 200 West Baltimore Street, Baltimore, MD 21201, or call 410-767-0386, or email to kelly.meadows@maryland.gov. Comments will be accepted through June 16, 2025. A public hearing has not been scheduled.

Open Meeting

Final action on the proposal will be considered by the State Board of Education during a public meeting to be held on July 29, 2025 at 9:00 am, at 200 West Baltimore Street, Baltimore, MD 21201.

.05 Supervisors of Instruction, Assistant Principals, and Principals.

A. Application of Regulation.

(1) This regulation applies to obtaining licensure as an Administrator.

(2) If a principal transfers to become a principal in a special education school, the principal shall hold a Supervisor of Special Education license as set forth in Regulation .10 of this chapter.

B. Administrator Requirements.

(1) This license qualifies an individual to be assigned as a supervisor of instruction, assistant principal, or principal.

(2) The applicant shall have:

(a) A master’s degree, or higher, from an accredited institution of higher education;

(b) Twenty-seven months of effective teaching performance or effective performance as a specialist as defined in COMAR 13A.12.04;

(c) Three semester hours or State-approved CPD credits in special education coursework; and

(3) The applicant shall meet one of the following pathways:

(a) A Department-approved program which leads to licensure as a supervisor of instruction, assistant principal, or principal;

(b) An approved out-of-State program that leads to licensure as a supervisor of instruction, assistant principal, or principal and includes a supervised clinical practicum;

(c) Eighteen semester hours of graduate coursework taken at an institution of higher education, to include coursework in the following categories:

(i) Curriculum, instruction, and assessment;

(ii) Supervision, evaluation, and supporting instructional improvement;

(iii) Legal issues and ethical decision-making;

(iv) Program/school administration;

(v) Culturally responsive leadership and/or equity in leadership; and

(vi) Supervised clinical practicum that is a minimum of 240 clock hours; or

(d) Holds a valid professional state license in administration from another state or country and has verification of 5 years of effective performance as an administrator in a PK-12 school setting.

(4) Applicants who qualify based on §3(b) or (c) of this regulation must present a qualifying score as established by the State Superintendent of Schools on a school leader licensure assessment approved by the State Board of Education.

CAREY M. WRIGHT, ED.D.

State Superintendent of Schools

Title 13B
MARYLAND HIGHER EDUCATION COMMISSION

Subtitle 02 ACADEMIC REGULATIONS

13B.02.01 Requirements for Authorization of Out-of-State Degree-Granting Institutions to Operate in Maryland

Authority: Education Article, §§10-212, 11-105, 11-201—11-207, and 16-108, Annotated Code of Maryland

Notice of Proposed Action

[25-065-P]

The Maryland Higher Education Commission proposes to amend Regulation .07 under COMAR 13B.02.01 Requirements for Authorization of Out-of-State Degree-Granting Institutions to Operate in Maryland. This action was considered at an open meeting of the Commission on January 22, 2025.

Statement of Purpose

The purpose of this action is to allow an out-of-State institution to provide a justification for why a proposed program should be offered at its Maryland campus when that or a similar program is not offered at its main or primary campus.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Emily A. A. Dow, Ph.D., Assistant Secretary for Academic Affairs, Maryland Higher Education Commission, 217. E. Redwood St., Suite 2100 Baltimore, MD 21202, or call 410-767-3049, or email to emily.dow@maryland.gov. Comments will be accepted through June 16, 2025. A public hearing has not been scheduled.

.07 Institutional Initial Approval Process.

A.—E. (text unchanged)

F. Secretary's Grant of Approval to Operate in Maryland.

(1) The Secretary shall grant the certificate of approval to the out-of-State institution to operate in Maryland on such conditions as may be considered appropriate, if the Secretary is satisfied that:

(a)—(b) (text unchanged)

(c) The programs to be offered in Maryland are similar to programs offered at its main or primary campus, unless the Secretary finds that the institution has provided sufficient justification otherwise.

(2) (text unchanged)

G.—I. (text unchanged)

SANJAY RAI, Ph.D.
Secretary of Higher Education

Subtitle 08 FINANCIAL AID

13B.08.22 Teaching Fellows for Maryland Scholarship Program

Authority: Education Article, §§11-105 and 18-204 and Title 18, Subtitle 22, Annotated Code of Maryland

Notice of Proposed Action

[25-066-P]

The Maryland Higher Education Commission proposes to amend Regulation .02 under COMAR 13B.08.22.02 Teaching Fellows for Maryland Scholarship Program. This action was considered at an open meeting of the Commission on January 22, 2025.

Statement of Purpose

The purpose of this action is to change the definitions of full-time and part-time for this scholarship so as to expand eligibility.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Geoff Newman, Assistant Secretary for Finance and Administration, Maryland Higher Education Commission, 201 E. Redwood St., Suite 2100, Baltimore, MD 21202, or call 410-767-3041, or email to geoff.newman@maryland.gov. Comments will be accepted through June 16, 2025. A public hearing has not been scheduled.

.02 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(4) (text unchanged)

(5) “Full-time” means enrollment in:

(a) [At least 12 credits per semester in] For an undergraduate certificate or degree program, at least 12 credits per semester; or

(b) [At least 9 credits per semester in] For a graduate certificate or degree program, the number of credits needed for the institution to classify the graduate student as full-time based on the institution’s policy.

(6)—(9) (text unchanged)

(10) “Part-time” means enrollment in:

(a) [At least 6 credits, but fewer than 12 credits, per semester in] For an undergraduate certificate or degree program, at least 1 credit, but fewer than 12 credits; or

(b) [At least 6 credits, but fewer than 9 credits, per semester in] For a graduate certificate or degree program, the number of credits needed for the institution to classify the graduate student as part-time based on the institution’s policy.

(11)—(14) (text unchanged)

SANJAY RAI, PH.D.

Secretary of Higher Education

Title 14
INDEPENDENT AGENCIES

Subtitle 39 INTERAGENCY COMMISSION ON SCHOOL CONSTRUCTION

14.39.04 Project Delivery Methods

Authority: Education Article, §§4-126, 5-112, and 5-303, Annotated Code of Maryland

Notice of Proposed Action

[25-079-P]

The Interagency Commission on School Construction proposes to amend Regulations .05 and .08 under COMAR 14.39.04 Project Delivery Methods. This action was considered by the Interagency Commission on School Construction at open meetings held on April 10, 2025 for which notice was given by publication on the General Assembly website pursuant to General Provisions Article, §3-302, Annotated Code of Maryland.

Statement of Purpose

The purpose of this action is to remove the requirement of advance notification prior to contract award for the use of Job Order Contracting and Construction Management Agency project delivery methods for Local Education Agency State Funded school construction projects.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Victoria Howard, Policy Analyst, Interagency Commission on School Construction, 351 W. Camden St. Baltimore MD 21201, or call 410-767-0600, or email to victoria.howard@maryland.gov. Comments will be accepted through June 16, 2025. A public hearing has not been scheduled.

.05 Construction Management Agency.

A. (text unchanged)

[B. Notice to the IAC.

(1) Not later than 2 months before the release of the solicitation documents to offerors, the LEA shall provide written notice to the IAC or its designee that the CMA method will be used.

(2) The LEA shall acknowledge in the notice that the State is not responsible for any project cost overruns.]

[C.] B. (text unchanged)

[D.] C. State Reimbursement.

[(1) If the LEA is not acting as construction manager, State funds may be used to reimburse allowable CMA costs associated with procuring and managing trade contracts, as defined by the IAC or its designee.]

[(2)] (1) (text unchanged)

[(3) CMA services provided during the design phase of the project are not eligible for State reimbursement.]

[(4)] (2)—[(5)] (3) (text unchanged)

.08 Job Order Contracting.

A.—D. (text unchanged)

E. Procurement and Award.

(1)—(2) (text unchanged)

(3) When submitting a contract approval to the IAC, the LEA must acknowledge that the State is not responsible for any project cost overruns.

F. Approvals. If an LEA intends to execute a State-funded project through a JOC, it:

[(1) If an LEA intends to execute a State-funded project through the JOC, it

(a) Shall provide the IAC or its designee with evidence that the JOC was procured competitively, including documents and the submissions from bidders or offerors;]

[(b)] (1) Shall provide the IAC or its designee with a brief description of the anticipated scope of work, the duration of the JOC contract, the number of annual extensions, and the maximum combined cost of the projects to be performed under the JOC,

[(c) May also include the anticipated minimum cost of each project and the estimated cost of all projects to be performed in each fiscal or calendar year.

(2) The LEA shall notify the IAC or its designee of its intention to use the JOC to execute a State-funded project at the earliest possible date, and shall provide the information required under §F(1)(a) of this regulation.

(3) The LEA shall acknowledge in the notification that the State is not responsible for any project cost overruns.

(4) Approval of Contracts or Reimbursement.

(a) The LEA shall obtain approval of project award, reimbursement, or both, in the manner and timeframe required for all projects funded under the relevant program.]

[(b)] (2) [Design] Shall submit the project for design review prior to the start of construction [shall be required] if it would be required for similar project funded through the same State funding program[.];

[(c)] (3) [If approval is requested for a project to be executed through a JOC under which a State-funded project was previously approved, the LEA may] May reference [the] an earlier approval and the JOC solicitation if approval is requested for a project to be executed through a JOC under which a State-funded project was previously approved, but is not required to resubmit all relevant information[.];

(4) Shall obtain approval of contract award, reimbursement, or both, in the manner and timeframe required for all projects funded under the relevant program;

[(d)] (5) [For] Shall, for design-build JOC projects, clearly indicate on the request for approval of [project] contract award or for reimbursement [shall clearly indicate] those portions of the project cost that are associated with preconstruction activities in order to allow the IAC or its designee to determine which costs are eligible for State reimbursement[.];

[(e)] (6) [Allowable] Shall include in the total construction cost allowable preconstruction services, as determined by the IAC [shall be included in the total construction cost.]; and,

[(f)] (7) [Final] Shall acknowledge that final adjustment of the State’s participation [shall] will be made at project closeout.

ALEX DONAHUE

Executive Director

Subtitle 41 STATE BOARD OF SIGN LANGUAGE INTERPRETERS

14.41.01 Licensing Requirements for Sign Language Interpreters

Authority: State Government Article, §§9-2410—9-2435, Annotated Code of Maryland

Notice of Proposed Action

[24-231-P]

The State Board of Sign Language Interpreters proposes to adopt new Regulations .01—.16 under a new chapter, COMAR 14.41.01 Licensing Requirements for Sign Language Interpreters, under a new subtitle, Subtitle 41 State Board of Sign Language Interpreters.

The licensing of sign language interpreters is under the authority and supervision of the State Board of Sign Language Interpreters (SBSLI).

Statement of Purpose

The purpose of this action is to establish regulations for the licensing of individuals to provide sign language interpretation services in Maryland in accordance with State Government Article, § 9-2410, et seq., Annotated Code of Maryland. This chapter does not apply to individuals providing sign language interpretation services as described in State Government Article, § 9-2418(b), Annotated Code of Maryland.

Estimate of Economic Impact

I. Summary of Economic Impact. Funding for Licenses Funding for sanctions Special funding for supporting licenses requirement.

II. Types of Economic Impact.

Impacted Entity	Revenue (R+/R-) Expenditure (E+/E-)	Magnitude
A. On issuing agency:
GODHH	(R+)	$144,179 net
B. On other State agencies:	NONE
C. On local governments:	NONE
	Benefit (+) Cost (-)	Magnitude
D. On regulated industries or trade groups:	NONE
E. On other industries or trade groups:	NONE
F. Direct and indirect effects on public:	NONE

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

A. In Fiscal Year (FY) 2025, this action will have a $144,179 net positive economic impact on the Office of the Deaf and Hard of Hearing’s (ODHH) budget. This amount represents revenue increases incurred through licensing fees collected from sign language interpreters, less portal fees, banking and other miscellaneous administrative expenses. Revenue from licensing fees will comprise the Sign Language Interpreters Fund.

Economic Impact on Small Businesses

The proposed action has a meaningful economic impact on small businesses. An analysis of this economic impact follows:

This could impact interpreter agencies and freelance interpreters.

Impact on Individuals with Disabilities

The proposed action has an impact on individuals with disabilities as follows:

(1) Deaf;

(2) DeafBlind; and

(3) Hard of Hearing.

Opportunity for Public Comment

Comments may be sent to Usherla DeBerry or Tanea Brown, Director, Governor's Office of the Deaf and Hard of Hearing, 100 Community Place, or call (443) 453-5761, or email to gov.odhh@maryland.gov. Comments will be accepted through June 16, 2025. A public hearing has not been scheduled.

.01 Purpose and Scope.

The purpose of this chapter is to establish regulations for the licensing of individuals to provide sign language interpretation services in Maryland in accordance with State Government Article, §9-2410, et seq., Annotated Code of Maryland. This chapter does not apply to individuals providing sign language interpretation services as described in State Government Article, §9-2418(b), Annotated Code of Maryland.

.02 Authority.

The licensing of sign language interpreters is under the authority and supervision of the State Board of Sign Language Interpreters (SBSLI).

.03 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Agency” means any for-profit or non-profit entity that provides or arranges for sign language interpretation services in the State for any individual or other entity, including but not limited to:

(a) Consumers;

(b) Government agencies;

(c) Places of public accommodation; and

(d) Employers.

(2)“American Sign Language (ASL)” means a distinct language specific to the United States and parts of Canada that is a visual-spatial method of communication involving the hands, arms, facial markers, and body movements to communicate with others, including through the conveyance of thoughts, words, emotions, and grammatical information.

(3) “Board” or “SBSLI” means the State Board of Sign Language Interpreters.

(4) “Continuing education unit” (CEU) means continuing education/ professional development required to obtain or renew a license issued under these regulations.

(a) One continuing education unit equals ten hours of continuing education.

(b) Continuing education units taken to maintain national or regional certification will be accepted.

(5) “Educational programs or services by a public, state-funded, or nonpublic school means any setting birth through secondary education”

(6) “License” means a license issued under these regulations to allow an individual or agency to provide sign language interpretation services.

(7) “Nationally or Regionally Recognized Certification” means:

(a) A sign language interpreting certification issued and recognized by one of the following:

(i) The Registry of Interpreters for the Deaf (RID); or

(ii) The Board of Evaluation for Interpreters (BEI).

(b) Any other certification issued by a national or regional organization that is recognized by the Board.

(8) “Office” or “GODHH” means the Governor’s Office of the Deaf and Hard of Hearing.

(9) Provide Sign Language Interpretation Services.

(a) “Provide Sign Language Interpretation Services” means to convey the meaning of a message that is expressed in:

(i) An oral or signed language by rendering the message in American Sign Language; or

(ii) American Sign Language by rendering the message in an oral or signed language.

(b) “Provide Sign Language Interpretation Services” includes providing sign language interpretation services in a video remote interpreting setting.

(10) “Provisional License” means a limited license issued by the Board to provide sign language interpretation services in limited settings for a limited period of time in accordance with these regulations.

(11) “Restorative justice program” means a program designed to repair harm caused to all individuals involved in a crime through mediation, dialogue, or group conferencing between a licensee and an aggrieved party or complaint.

(12) “Video Relay Service (VRS)” means the federally reimbursed and regulated program established to enable phone calls between users of American Sign Language and individuals who do not use American Sign Language by videoconferencing technology and the use of the services of a remotely located sign language interpreter.

(13) Video Remote Interpreting (VRI).

(a) “Video Remote Interpreting (VRI)” means providing sign language interpretation services by videoconferencing in which the participants are in one location and the interpreter is in a separate location.

(b) Video Remote Interpreting is also known as Virtual Interpreting, where any party that is utilizing sign language interpreting services is remote.

(c) “Video Remote Interpreting (VRI)” does not include Video Relay Service.

.04 License Required.

A. General. An individual shall be licensed by the Board before an individual may:

(1) Provide sign language interpretation services for compensation; or

(2) Represent to the public, by description of services or use of a title or designation, that the individual is authorized to provide sign language interpretation services.

B. Specialty Areas. An individual shall be licensed by the Board in a specialty area and level, if applicable, before an individual may:

(1) Provide sign language interpretation services for compensation in that specialty area as authorized based on the level, if applicable; and

(2) Represent to the public, by description of services or use of a title, designation, or level, that the individual is authorized to provide sign language interpretation services in any specialty area and level, if applicable.

C. Authorization.

(1) An active license issued by the Board authorizes the licensee to provide sign language interpretation services within the scope of the general or specialty areas as indicated by the Board.

(2) The Board authorization to provide sign language interpretation services is contingent upon the individual maintaining any nationally or regionally recognized certification required for the license.

D. Exceptions. The licensure requirements of this regulation do not apply to the following:

(1) An individual who provides sign language interpretation services as part of a video relay service;

(2) An individual who provides sign language interpretation services as an uncompensated volunteer and in a setting in which a sign language interpreter is not otherwise required by law;

(3) An individual described in State Government Article, §9-2418(b)(3), Annotated Code of Maryland, who does not provide sign language interpretation services in the State for more than 80 hours each calendar year, if the individual:

(a) Self-certifies eligibility for this exemption; and

(b) Notifies the Board of each sign language interpreting assignment within 10 days after completing the assignment; and

(4) Any other individual identified in State Government Article, §9-2418(b), Annotated Code of Maryland.

E. Nontransferable. All licenses issued by the Board are non-transferable.

F. Required Notification. Any licensee, within 60 days of the change, shall notify the Board in writing of any change in the following:

(1) Any event that results in the revocation, suspension, expiration, or any other event that impacts the validity of any nationally or regionally recognized certification required for the license; or

(2) The licensee’s name, email address, or mailing address.

G. Waivers.

Pursuant to the discretion granted to the Board in State Government Article, §9-2420, Annotated Code of Maryland, the Board elects not to waive any requirement of State Government Article, Title 9, for an applicant who is licensed to provide sign language interpretation services in another state.

H. Validity Period. Unless otherwise specified, any license issued by the Board is valid for 1 year from the date of issuance.

.05 General License Qualifications.

A. To qualify for a license to provide sign language interpretation services for the general community, an individual shall have a valid nationally recognized certification from one of the following organizations at the required level, if applicable:

(1) Board for Evaluators of Interpreters (BEI) at the basic level or higher;

(2) National Association of the Deaf (NAD) at Level III or higher; or

(3) Registry of the Interpreters for the Deaf (RID).

B. Restrictions. An individual who holds a license to provide sign language services for the general community may not provide any sign language interpretation services in a specialty area unless permitted under these regulations.

.06 Provisional License.

A. An individual who is unable to meet the licensure requirements of this chapter may apply for a provisional license.

B. To qualify for a provisional license to provide sign language interpretation services for the general community, the individual shall:

(1) Be 18 years or older;

(2) Have a high school diploma or a certificate of high school equivalence, or courses from an accredited college or university; and

(3) Obtain a passing score on the knowledge and ethics written exam from either:

(a) The Registry of Interpreters for the Deaf (RID); or

(b) The Board of Evaluation for Interpreters (BEI);

C. To qualify for a provisional license to provide sign language interpretation services for the education or school setting, the individual shall:

(1) Be 18 years or older and;

(2) Have a high school diploma or a certificate of high school equivalence, or courses from an accredited college or university and;

(3) Have RID ED:K-12 or;

(4) Pass the EIPA written exam and obtain a minimum score of 3.7 on the EIPA for either the:

(a) PSE-ASL assessment; or

(b) ASL-PSE assessment.

D. Restrictions.

(1) An individual who holds a provisional license to provide sign language interpretation services for the general community may not provide any sign language interpretation services in a specialty area except in a medical setting if part of a formal mentorship or if the individual is accompanied by a licensed sign language interpreter.

(2) An individual who holds an education provisional license to provide sign language interpretation services may only provide sign language interpretation in educational programs and services.

E. Validity Period. A provisional license is valid for 3 years from the date of issuance.

F. Renewal for Provisional General Community License. An individual may only renew a provisional license one time for an additional 2-year period if the individual:

(1) Earns 2.0 units (20 hours) of continuing education in interpreting and relevant topics;

(2) One of the hours required in § E(1) of this regulation shall include power, privilege, and oppression (PPO) studies.

G. Renewal for Provisional Education Specialty. An individual may only renew a provisional education specialty one time for an additional 2 years if the individual:

(1) Earns 2.0 units (20 hours) of continuing education in educational interpreting and relevant topics;

(2) One of the hours required in § F(1) of this regulation shall include power, privilege, and oppression (PPO) studies, including deaf culture, deaf awareness, and diversity in education.

H. Expiration. An individual may not hold a provisional license for more than 5 years.

.07 Agencies.

A. Agencies shall be registered as a business in good standing with the State of Maryland and provide the following information to the Office:

(1) Name;

(2) Areas of interpreting services provided;

(3) Proof of legal existence; and

(4) Proof of good standing

B. Agencies shall provide provisionally licensed or fully licensed interpreters in all settings.

.08 Consumer Choice.

A. Interpreters and agencies shall provide sign language interpreting services via VRI or on-site, in-person interpreting according to the preference of the consumer.

B. Prior to accepting a request for services, interpreters and agencies must ask the requester of the services whether the consumer prefers VRI or on-site, in-person interpreting.

C. If the requester is requesting one type of service and the consumer prefers the other type, the interpreter or agency shall not provide sign language interpreting services.

D. In the case of an emergency, interpreters and agencies may provide sign language interpreting services via VRI for up to sixty (60) minutes.

.09 Application.

A. An applicant shall:

(1) Submit a completed application form, supplied by the Office;

(2) Provide identification which shall include a valid:

(a) Driver’s license;

(b) State-Issued identification; or

(c) Passport;

(3) Submit a 2x2 inch (passport-sized) photo of the applicant;

(4) Submit documentation that the applicant has met:

(a) Any required certifications;

(b) Any required education qualifications;

(c) Any required experience qualifications; and

(d) Any required continuing education hours; and

(5) Submit payment for any required fees.

B . Fees.

(1) All fees are paid annually unless specified otherwise and are nonrefundable. The fees are as follows:

(a) Initial application for general community non-provisional license—$150;

(b) Initial 3-year provisional license—$300;

(c) Renewal application for general community non-provisional license—$100;

(d) Provisional 2-year license renewal for general community or education specialty—$150;

(e) Reactivation fee—$150;

(f) Initial agency application—$250;

(g) Agency renewals—$200; and

(h) Late renewal application (31 or more days after renewal date)—$75.

(2) If a provisional licensee qualifies for a non-provisional license the Board may prorate a portion of the $300 fee to cover any additional application fees.

.10 Approval.

A. Upon receiving a completed application under Regulation .09 of this chapter and all documentation required by law or regulation, the Office shall determine compliance with the requirements of this chapter by evaluating the application and required documentation.

B. The Office, within 30 working days after receipt of a full application including all required documentation, shall:

(1) Approve or deny the application; and

(2) Upon approval of an application, ask the Board to issue the interpreter a license authorizing the applicant to provide sign language interpreting services in accordance with the regulations in this chapter.

C. Except with the approval of the Board, an applicant may not withdraw an application while under investigation or having received a notice of denial of licensure.

D. If the Office denies an application, the Office shall notify the applicant in writing by certified mail of the denial, stating the:

(1) Reason for the denial;

(2) Specific regulation with which the applicant has failed to comply that is the basis for the denial;

(3) Applicant’s right to request a hearing; and

(4) Procedure to be used if the applicant wishes to request a hearing to appeal the decision of the Office.

E. A hearing on the denial of an application shall be conducted in accordance with Regulation .12 of this chapter.

.11 Suspension, Revocation, and Fines.

A. If a licensee or applicant violates any provision in State Government Article, §9-2426, Annotated Code of Maryland, or any provision of §B of this regulation, the Board may initiate disciplinary proceedings to:

(1) Deny a license to any applicant;

(2) Reprimand any licensee;

(3) Suspend a license;

(4) Summarily suspend a license;

(4) Revoke a license:

(5) Require a licensee to attend an educational course or training;

(6) Impose a fine not to exceed $500.00 for each violation; or

(7) Use a restorative justice program in lieu of taking final action on a complaint.

B. The actions listed in §A of this regulation may be imposed if an applicant or a licensee:

(1) Fraudulently or deceptively obtains or attempts to obtain a license for the applicant, licensee, or another individual;

(2) Fraudulently or deceptively uses a license;

(3) Provides sign language interpretation services after the expiration of a license or outside the scope of the license;

(4) Is deemed legally incompetent to provide sign language services;

(5) Engages in dishonest, unethical, immoral, or unprofessional conduct as defined in the RID-NAD Code of Professional Conduct or its successor;

(6) Uses alcohol or drugs before or during a sign language interpreting assignment, to the extent of being unfit to provide sign language interpretation services;

(7) Is the subject of disciplinary or other administrative action taken against the individual’s certification or license to provide sign language interpretation services in another state; or

(8) Violates any provision of the State Government Article, §§9-2410—9-2435, Annotated Code of Maryland, or any regulation in this chapter.

C. The Board shall commence disciplinary proceedings under this regulation upon receipt of a complaint submitted to the Board against an applicant or licensee if:

(1) The complaint is made by a person other than a member of the Board;

(2) The complaint is made under oath by the person who submits the complaint;

(3) The complaint states specifically the facts on which the complaint is based;

(4) The Board will conduct a meeting with all involved parties to collect evidence; and

(5) The Board finds that a complaint alleges facts that are adequate grounds for action under State Government Article, §9-2426, Annotated Code of Maryland and this regulation.

D. The Board shall consider the severity of the violation and whether the violation constitutes a pattern of improper conduct, prior to imposing any disciplinary action.

E. If a license is suspended or revoked, the original license shall be surrendered within 5 business days of the Board’s decision.

(1) The license shall be presented in person at the Office; or

(2) Mailed to the Office via registered mail within 5 business days of the date of the Board’s decision.

F. During the suspension or revocation period of a license, the licensee shall not engage in any interpreting work.

G. During the revocation period of a license, the licensee may not reapply for licensure for a minimum of 3 months, which will include the investigation period. The final length of the revocation period will be determined by the Board.

H. An individual who violates the terms of the suspension or disciplinary action may be subject to additional disciplinary action by the Board.

.12 Due Process and Hearings.

A. Prior to imposing any penalty under Regulation .11 of this chapter, the Board shall notify the licensee by certified mail 30 calendar days in advance of the imposition of any such penalty, and the notice shall specify:

(1) The Penalty the Board intends to impose;

(2) The effective date and period of the penalty;

(3) The reason for the penalty;

(4) The regulatory violation which is the basis for the penalty;

(5) Notification if the licensee may continue to provide sign language services during the penalty period; and

(6) Notice that the licensee may request a hearing before the Office of Administrative Hearings.

B. If the license holder or applicant requests a hearing in writing within the 30-day period, the Board shall promptly refer the case to the Office of Administrative Hearings.

C. Hearing procedures are in accordance with the Administrative Procedure Act, State Government Article, §10-201 et seq., Annotated Code of Maryland, and with COMAR 28.02.

D. The administrative law judge shall determine if the charges against the license holder or applicant are supported by a preponderance of the evidence.

E. The administrative law judge shall submit in writing to the Board proposed findings of fact, proposed conclusions of law, and recommendations. The administrative law judge shall distribute this written proposed decision to the parties.

F. A party objecting to the administrative law judge's proposed decision may file exceptions with the Board within 15 calendar days of the date of the decision, and:

(1) The party filing exceptions shall ensure that a copy of the exceptions is provided to the opposing party;

(2) An opposing party may respond to the exceptions within 15 calendar days of the date of the exceptions;

(3) All parties shall have an opportunity for oral argument before the Board before a final decision is made;

(4) The Board shall limit oral/signed argument to 15 minutes per side;

(5) The Board may refuse to consider facts that the party could have produced at the hearing; and

(6) The Board may abrogate, change, or modify the original decision, or remand the case to the Office of Administrative Hearings.

.13 Record of Hearings.

A. The Office of Administrative Hearings shall prepare an official case record as provided in COMAR 28.02.01.23.

B. The Office of Administrative Hearings shall record the proceedings before the administrative law judge.

C. A party requesting a transcript of the proceedings, or part of the proceedings, shall pay the costs of the transcript, and a party requesting an expedited transcript shall pay the costs of the expedited transcript.

.14 Restorative Justice.

A. The Board may use a restorative justice program upon request by the complainant.

B. The Board shall contract with qualified restorative justice mediator(s) or facilitator(s) to lead this process.

.15 Grace Period.

Individuals shall not be subject to penalty for failing to comply with the provisions of this chapter until January 1, 2026.

.16 Reinstatement After a Period of Inactivity, Suspension, or Revocation.

A. The Board shall reinstate the license of an individual who for any reason has failed to renew the license if the individual:

(1) Applies to the Board for reinstatement;

(2) Meets the renewal requirements of Regulations .06 or .07 of this chapter; and

(3) Pays to the Board the renewal fee and the reinstatement fee set by the Board.

B. The Board shall reinstate the license of an individual whose license has been suspended if the individual:

(1) Applies to the Board for reinstatement after the period of suspension has ended;

(2) Meets the renewal requirements of Regulations .06 or .07 of this chapter; and

(3) Pays to the Board the renewal fee and the reinstatement fee set by the Board.

C. The Board may reinstate the license of an individual whose license has been revoked if the individual:

(1) Applies to the Board for reinstatement no less than 5 years after their license was revoked.

(2) Presents to the Board a petition demonstrating good cause for reinstatement;

(3) Meets the renewal requirements of .06 or .07 of this chapter; and

(4) Pays to the Board the renewal fee and reinstatement fee set by the Board.

USHERLA DEBERRY

Director

Title 15
MARYLAND DEPARTMENT OF AGRICULTURE

Subtitle 06 PLANT PEST CONTROL

15.06.04 Regulation of Invasive Plants

Authority: Agriculture Article; §§2-103(b) and 9.5-301 et. seq; Annotated Code of Maryland

Notice of Proposed Action

[25-022-P]

The Maryland Department of Agriculture proposes to amend Regulations .02—.06 and repeal existing Regulation .07 under COMAR 15.06.04 Regulation of Invasive Plants.

Statement of Purpose

The purpose of this action is to implement new legislation altering the regulatory approach for controlling invasive plant species in the State, including requiring the Secretary of Agriculture to establish a list of prohibited invasive plants by regulation. See Ch. 589, Acts of 2024.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Kimberly Rice, Program Manager, Maryland Department of Agriculture, 50 Harry S. Truman Parkway, Annapolis, Maryland 21401, or c all 410-841-5920, or email to kimberly.rice@maryland.gov. Comments will be accepted through June 16, 2025. A public hearing has not been scheduled.

.02 Definitions.

A. (text unchanged)

B. Terms Defined.

(1) “Classify as a prohibited invasive plant” means the Secretary is including an invasive plant on the Consolidated List of Maryland Invasive Plant Species in accordance with the Agriculture Article, §§9.5-301 and 9.5-301.1, Annotated Code of Maryland.

[(1)](2) (text unchanged)

(3) “Committee” means the Invasive Plants Advisory Committee.

(4) “Consolidated List of Maryland Invasive Plant Species” means a list of plant species classified as prohibited invasive plants in accordance with Agriculture Article, §§9.5-301 and 9.5-301.1, Annotated Code of Maryland.

(5) “Early Detection Rapid Response (EDRR) Plant Species” means a nonnative plant species that:

(a) Is not yet widespread in the State but is at risk of:

(i) Becoming established as an invasive species; and

(ii) Causing significant damage; and

(b)Has:

(i) Been found in at least one native species habitat in the State; or

(ii) Not yet been found in the State.

(6)“Expert Assessor” means:

(a) An individual or a team within the Department or the Department of Natural Resources; or

(b) A qualified independent assessor.

[(2)](7) Invasive Plant.

(a) “Invasive plant” means [a terrestrial plant species] any living part of a plant species or its subspecies that:

[(a)](i)—[(b)](ii) (text unchanged)

(b) “Invasive plant” includes a commercial or noncommercial plant that is terrestrial or aquatic and meets the definition under §B(7)(a) of this regulation.

[(3) “Off-site” means property other than where the Tier 1 invasive plant exists, including property under the control of the person removing the Tier 1 plant but not contiguous, for example, separated by a road or property owned by another person.

(4) “Tier 1 invasive plant” includes invasive plant species that cause or are likely to cause severe harm within the State.

(5) “Tier 2 invasive plant” includes invasive plant species that cause or are likely to cause substantial negative impact within the State.

(6) “Transport” means when a person moves a Tier 1 invasive plant anywhere within the State, including for transportation or shipment.]

(8) “Invasive Plant Species Status Assessment Protocol” means a protocol based on the NatureServe’s 2004 protocol (An Invasive Species Assessment Protocol: Evaluating Non-Native Plants for the Impact on Biodiversity. Version 1.)

(9)“Invasiveness Rank” means a rank assigned to a nonnative species to signify its level of invasiveness based on the results of an invasive assessment protocol. “Invasiveness Rank” includes an invasiveness significance ranking of high, medium, low, or insignificant.

(10)“Landscaping services” includes services for ornamental horticultural design, maintenance, and installation of living plants.

(11) “Prohibited invasive plant” includes invasive plant species that cause or are likely to cause severe harm within the State.

(12) “Qualified independent assessor” means an individual or team that:

(a) Possesses at least 2 years of field experience in invasive plant species in Maryland or in nearby jurisdictions, including Washington, D.C., Delaware, New Jersey, New York, Pennsylvania, Virginia, and West Virginia; and

(b) Has assessed invasive plant species without supervision from the Department, the Department of Natural Resources or the Committee

(13) “Watch List” means a list of plant species that:

(a) Have been assessed by an expert assessor in accordance with Agriculture Article, 9.5-301, Annotated Code of Maryland;

(b) Were not determined by the assessment to be eligible for classification as a prohibited invasive plant; and

(c) May be reassessed in the future.

.03 [Risk] Invasive Plant Species Status Assessment Protocol [for Invasive Plants].

A. The Secretary shall determine whether an invasive plant qualifies as a [Tier 1 or a Tier 2] prohibited invasive plant or a plant for the Watch List based on the following protocols to be completed by a qualified assessor:

(1) Plant risk assessment protocol [established by] based on the NatureServe’s 2004 protocol (an invasive species assessment protocol: evaluating non-native plants for their impact on biodiversity. Version 1.) [United States Department of Agriculture, Animal and Plant Health Inspection Service, Plant Protection Quarantine pursuant to A. Koop, L. Fowler, L. Newton, and B. Caton, Development and Validation of a Weed Screening Tool for the United States, Biological Invasions (2012) 14:273-294, which is incorporated by reference]; and

(2) Factors relating to special Maryland circumstances (e.g. potential distribution, current distribution, threatened and endangered species or ecosystems, feasibility of control, and special agricultural conditions)[.];

B. Assessments will be completed by a qualified independent assessor; and

C. All assessments will be reviewed and approved by the Invasive Plant Advisory Committee.

.04 [Tier 1]Prohibited Plant Prohibitions and Approvals.

A. Except as approved by the Secretary under this regulation, a person may not propagate, import, transfer, sell, purchase, transport, or introduce any living part of a [Tier 1] prohibited invasive plant in the State.

B. (text unchanged)

C. A person has the Secretary's approval and may engage in any activity prohibited by §A of this regulation for the limited purpose of:

(1) Controlling a [Tier 1] prohibited invasive plant, provided:

(a)—(c) (text unchanged)

(2) Transporting a [Tier 1] prohibited invasive plant off-site for the purpose of identification or disposal, provided:

(a)—(b) (text unchanged)

D. For approvals not granted under §C of this regulation, a person may submit a written request to the Secretary for approval of any activity allowed under §B of this regulation with the following information:

(1)—(4) (text unchanged)

(5) [Tier 1] Prohibited invasive plant for which approval is being requested (full botanical name);

(6) Specific location of the [Tier 1] prohibited invasive plant;

(7)—(10) (text unchanged)

E. (text unchanged)

.05 Administrative Orders by the Secretary.

A. The Secretary may issue administrative orders to enforce the provisions of this chapter and Agriculture Article, Title 9.5 (Invasive Plants Prevention and Control), Annotated Code of Maryland, as follows:

(1) Order any person to cease propagating, importing, transferring, selling, purchasing, transporting, or introducing any living part of a [Tier 1] prohibited invasive plant in the State;

(2) Order the condemnation and seizure of any [Tier 1] prohibited invasive plant owned or possessed by any person who violates [§9.5-302(a)(2) of the] Agriculture Article, §9.5-302(b), Annotated Code of Maryland;

(3) Order the marking or tagging in a conspicuous manner of a [Tier 1] prohibited invasive plant owned or controlled by any person subject to an order of the Secretary under this chapter;

(4) Order any person, on notice from the Secretary, to dispose of any [Tier 1] prohibited invasive plant that is held in violation of this chapter or in violation of Agriculture Article, Title 9.5, Annotated Code of Maryland, in a manner that renders all plant parts nonviable, or allow a person to return a [Tier 1] prohibited invasive plant to the out-of-State supplier of the plant, as approved in advance by the Secretary;

(5) Order a person to make any [Tier 1] prohibited invasive plant available to the Secretary for destruction if the person has failed to dispose of the [Tier 1] prohibited invasive plant as ordered by the Secretary and require that person to pay any destruction cost;

[(6) Order any person to cease selling or offering for sale at any retail outlet a Tier 2 invasive plant until the retail outlet posts in a conspicuous manner in proximity to all Tier 2 plant displays a sign identifying the plants as Tier 2 plants;

(7) Order any person to cease providing landscaping services to plant or supply for planting a Tier 2 invasive plant, if the person fails to provide the customer with a list of Tier 2 invasive plants; or]

[(8)] (6) (text unchanged)

B. (text unchanged)

.06 [Tier 1 and Tier 2] Prohibited Invasive Plants and Watchlist Plants.

A. Prohibited invasive plants are those plants listed on the Consolidated List of Maryland Invasive Plant Species found on the Maryland Department of Agriculture’s website located at __https://mda.maryland.gov/plants-pests/Pages/maryland_invasive_plants_prevention_and_control.aspx_[The following plants are classified as Prohibited Tier 1 invasive plants upon adoption of this regulation (see Department's website for adoption date http://mda.maryland.gov/plantspests/Pages/maryland invasive plants prevention and control.aspx) :

(1) Ficaria verna (fig buttercup);

(2) Geranium lucidum (shining cranesbill);

(3) Iris pseudacorus (yellow flag iris);

(4) Euonymus fortune (wintercreeper);

(5) Lonicera maackii (Amur honeysuckle); and

(6) Corydalis incisa (incised fumewort).]

B. Phase-out periods for [Tier 1 Plants] prohibited invasive plants.

(1) A person in possession of a [Tier 1] prohibited invasive plant, except a person who is growing a woody plant in ground, shall comply with the [Tier 1] prohibited invasive plant provisions of this chapter within [1 year] 2 years of that plant’s effective date on the [Tier 1] prohibited invasive plant list.

(2) A person who is growing a [Tier 1 woody] prohibited invasive plant in ground shall comply with the provisions of this chapter within [2] 5 years from that plant’s effective date on the [Tier 1] Prohibited Invasive Plant list.

(3) A person may not acquire a new [Tier 1] prohibited invasive plant after that plant’s effective date on the [Tier 1] prohibited invasive plant list.

C. [The following plants are classified as Tier 2 invasive plants upon adoption of this regulation (see Department's website for adoption date http://mda.maryland.gov/plants-pests/Pages/maryland invasive plants prevention and control.aspx):

(1) Euonymus alatus (burning bush);

(2) Ligustrum obtusifolium (blunt-leaved or border privet);

(3) Wisteria sinensis (Chinese wisteria);

(4) Wisteria floribunda (Japanese wisteria);

(5) Wisteria xormosa (floribunda x sinensis hybrids);

(6) Cytisus scopoarius, (Scotch broom);

(7) Nandina domestica (heavenly bamboo), except for the cultivar Firepower;

(8) Phyllostachys aurea (golden bamboo);

(9) Phyllostachys aureosulcata (yellow groove bamboo);

(10) Pyrus calleryana (Callery pear);

(11) Tetradium daniellii (bee bee tree);

(12) Aralia elata (Japanese angelica-tree); and

(13) Berberis thunbergii (Japanese barberry).] The Secretary shall maintain a listing of plants on the Watch List, which listing may be amended from time to time.

[D. A person shall comply with the Tier 2 provisions of this chapter within 3 months of a plant's effective date on the Tier 2 list.]

[E]. D. Procedures for Classification or Declassification of a [an Invasive Plant] prohibited invasive plant [as a Tier 1 Invasive Plant or Tier 2 Invasive Plant] and associated cultivars.

(1) A person who requests the classification or declassification of a plant as a [Invasive Plant as a Tier 1 or Tier 2 invasive plant] prohibited invasive plant, shall submit a written request to the Secretary that includes the name of the requestor, contact information, scientific name of the plant, and a justification for the request.

(2) Upon receipt of the request the Secretary, in consultation with the Invasive Plant Advisory Committee, shall make a determination, considering:

(a) (text unchanged)

(b) If the plant has already been assessed pursuant to Regulation .03 of this chapter, whether new, science-based information is available that could change the species' [tier ranking] designation as a prohibited invasive plant; and

(3) (text unchanged)

[F]. E. Distribution of the Prohibited Invasive Plant List and the Watch List [of Tier 2 Invasive Plants].

(1) The Secretary shall send [a list of Tier 2 invasive plants] the Prohibited Invasive Plant List and the Watch List with annual renewal letters and with each new application for a nursery, plant dealer, or plant broker license.

(2) The Secretary shall post the [current list of Tier 2 invasive plants] Prohibited Invasive Plant List and the Watch List on the Department's website.

(3) A person in the business of providing landscaping services who plants or supplies for planting a plant on the Watch List [Tier 2 invasive plant] shall provide to the customer requesting the service the [list of Tier 2 invasive plants] Watch List.

[G.] F. Disposal of [Tier 1 Plants] prohibited invasive plants. Any person who removes a [Tier 1 plant] prohibited invasive plant off-site shall ensure that:

(1)—(2) (text unchanged)

STEVEN A. CONNELLY
Deputy Secretary

Title 26
DEPARTMENT OF ENVIRONMENT

Subtitle 13 DISPOSAL OF CONTROLLED HAZARDOUS SUBSTANCES

Authority: Environment Article, Title 7, Subtitle 2, Annotated Code of Maryland

Notice of Proposed Action

[24-159-P]

The Secretary of the Environment proposes to:

(1) Amend Regulations .03, .04, and .05 under COMAR 26.13.01 Hazardous Waste Management System: General;

(2) Amend Regulations .01, .04, .04-1, .05, .06, .07, .07-1, .11, .13, .16, .19, and .23, and adopt new Regulation .04-7 under COMAR 26.13.02 Identification and Listing of Hazardous Waste;

(3) Amend Regulations .01, .01-1, .02, .03-3, .03-4, .03-5, .03-7, .05, .05-4, and .06 under COMAR 26.13.03 Standards Applicable to Generators of Hazardous Waste;

(4) Amend Regulation .01 under COMAR 26.13.04 Standards Applicable to Transporters of Hazardous Waste;

(5) Amend Regulations .01, .04, .05 and .14, under COMAR 26.13.05 Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities;

(6) Amend Regulations .01, .02, .05, and .22 under COMAR 26.13.06 Interim Status Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities;

(7) Amend Regulations .01, .02, .02-6, ,17, .20, and .20-1—.20-6 under COMAR 26.13.07 Permits for CHS Facilities; (8) Amend Regulation .01 under COMAR 26.13.09 Land Disposal Restrictions; (9) Amend Regulations .01, .04, .06, .08, .14, .17, .19, .20, and .25, and adopt new Regulations .09-1, .16-1, and .32—.49 under COMAR 26.13.10 Standards for the Management of Specific Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities; and

(10) Amend Regulation .01 under COMAR 26.13.11 Special Medical Wastes.

Statement of Purpose

The purpose of this action is to revise COMAR 26.13 so that State regulations are consistent with the following elements of the federal hazardous waste regulatory program:

(1) Management standards for hazardous waste pharmaceuticals at healthcare facilities;

(2) Revisions to the ignitability characteristic definition;

(3) Management standards for waste automotive airbags;

(4) Exclusions for solvent-contaminated wipes; and

(5) Addition of aerosol cans to the list of universal wastes.

There are also various technical corrections that involve such things as removal of obsolete provisions, adoption of required provisions that had previously been omitted in error, changing dates for incorporations by reference to make them current, and revisions to correct inconsistencies that the U.S. Environmental Protection Agency had identified in corresponding federal regulations.

This action also revises administrative requirements for hazardous waste permitting so that the regulations are consistent with sections 1-601 thru 1-606 of the Environment Article, Annotated Code of Maryland.

Estimate of Economic Impact

I. Summary of Economic Impact. The primary economic impact of the regulatory amendments is expected to be incurred by the healthcare sector, but it is estimated that the costs will be a tiny fraction of the gross domestic product of the healthcare industry in the state. Other elements of the proposed action are expected to produce cost savings for hazardous waste generators in general by providing alternate, simplified management standards, but these savings are difficult to quantify.

II. Types of Economic Impact.

Impacted Entity	Revenue (R+/R-) Expenditure (E+/E-)	Magnitude
A. On issuing agency:
Department of the Environment Solid Waste Program	(E+)	Minimal
B. On other State agencies:
Various - agencies that generate hazardous waste in connection with their operations.	(E-)	Not reliably quantifiable.
C. On local governments:
Various - local governments that generate hazardous waste in connection with their operations.	(E-)	Not reliably quantifiable.
	Benefit (+) Cost (-)	Magnitude
D. On regulated industries or trade groups:
(1) Health care facilities that generate hazardous waste pharmaceuticals	(-)	Aggregate cost of $352,000 for the healthcare sector in the State.
(2) Hazardous waste generators in general	(+)	Not reliably quantifiable.
E. On other industries or trade groups:
Not applicable	(+)	Not applicable
F. Direct and indirect effects on public:
	(+)	Not reliably quantifiable.

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

A. (Implementation costs - mainly costs of compliance monitoring and compliance assistance.) The proposed action is not anticipated to require the hiring of any new staff. Implementation is expected to be able to be accomplished using existing resources.

B. Agency expenditures for hazardous waste management may decrease if an agency is able to take advantage of provisions that allow for alternate, simplified management standards for certain hazardous wastes.

C. Agency expenditures for hazardous waste management may decrease if an agency is able to take advantage of provisions that allow for alternate, simplified management standards for certain hazardous wastes.

D(1). In the preamble of the Federal Register notice for the proposal of the federal regulations on management standards for hazardous waste pharmaceuticals at healthcare facilities, the EPA provided an estimated annual compliance cost of 13 million dollars nationwide (89 Fed, Reg, 58075, 9/25/15). This figure was used as the basis for developing an estimate of costs that would be incurred by healthcare facilities in Maryland.

An estimate of the size of the healthcare industry in Maryland as a percentage of the domestic healthcare industry was generated by assuming that the percentage is the same as the percentage of the national Gross Domestic Product (GDP) for the healthcare industry that is generated by the Maryland healthcare industry. Data from the U.S. Department of Commerce Bureau of Economic Analysis (BEA) for 2014 indicates that national GDP for the healthcare and social assistance category was 1,224,867 million dollars, and GDP for the same category in Maryland was 25,657 million dollars. Dividing the State figure by the national figure yields an estimate that the Maryland healthcare sector is approximately 2.09 percent of the national health care sector. Multiplying $13 million by 0.021 and then applying an inflation factor of 1.2970 based on Bureau of Economic Analysis implicit price deflators for GDP from 2014 and 2024 yields an estimated cost for Maryland facilities of $352,000 (rounded to nearest $1,000).

D(2). Expenditures for hazardous waste management may decrease if a generator of hazardous waste is able to take advantage of provisions in the proposed action that allow for alternate, simplified management standards for certain hazardous wastes.

F. The public will continue to benefit from the safe management of hazardous waste and the associated avoidance of adverse impacts to human health and the environment, and will benefit from an elimination of the disposal of hazardous waste pharmaceuticals via discharge to sewer systems, but a specific value for the benefits to the public that would result from the proposed action is impossible to quantify.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Edward Hammerberg, RCE Supervisor, Maryland Department of the Environment, Solid Waste Program, 1800 Washington Blvd., STE 605, Baltimore, MD 21230-1719, or call (410) 537-3356, or email to ed.hammerberg@maryland.gov. Comments will be accepted through June 16, 2025. A public hearing has not been scheduled.

26.13.01 Hazardous Waste Management System: General

Authority: Environment Article, §6-905.3 and Title 7, Subtitle 2, Annotated Code of Maryland

.03 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(2-1) (text unchanged)

[(2-1-1)] (2-2) (text unchanged)

(2-3) “Aerosol can” means a non-refillable receptacle that:

(a) Contains a gas compressed, liquified, or dissolved under pressure, the sole purpose of which is to expel a liquid, paste, or powder; and

(b) Is fitted with a self-closing relief device that allows the contents to be ejected by the gas.

(2-4) “Airbag inflator” means a small metal canister within an airbag module that generally houses explosive propellant and an initiator, and that causes an airbag module to deploy when an electronic pulse is received from a vehicle’s crash sensor.

(2-5) “Airbag module” means a fully assembled unit that includes both an airbag inflator and the fabric cushion that is designed to inflate and deploy in the event of a vehicle crash.

(2-6) “Airbag waste” means a hazardous waste airbag module or hazardous waste airbag inflator.

(2-7) Airbag Waste Collection Facility.

(a) “Airbag waste collection facility” means a facility that receives airbag waste from an airbag handler that is operating under the provisions of COMAR 26.13.02.04-7; and

(b) “Airbag waste collection facility” does not include a facility that accumulates in-transit airbag waste for 10 days or less.

(2-8) “Airbag waste handler” means a person, by site, that generates airbag waste that is subject to regulation under this subtitle.

[(2-2) ] (2-9)—[(2-3)] (2-10) (text unchanged)

(3) — (16-1) (text unchanged)

(16-2) “Drug Enforcement Administration” means the United States Drug Enforcement Administration;

[(16-2)] (16-3)—[(16-4)] (16-5)(text unchanged)

(17) — (20) (text unchanged)

(20-1) “Evaluated hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that:

(a) Has been evaluated by a reverse distributor in accordance with COMAR 26.13.10.49 and 40 CFR §266.510(a)(3); and

(b) Will not be sent to another reverse distributor for further evaluation or verification of manufacturer credit.

(21) — (24-2) (text unchanged)

(25) “Final closure” means the closure of all hazardous waste management units at the facility in accordance with all applicable closure requirements so that hazardous waste management activities under COMAR 26.13.05 and 26.13.06 are no longer conducted at the facility unless subject to the provisions in COMAR 26.13.03.03-3—.03-10 and COMAR 26.13.03.05-1—.05-2.

(26)—(34) (text unchanged)

(34-1) Hazardous Waste Pharmaceutical.

(a) “Hazardous waste pharmaceutical” means a pharmaceutical that is a solid waste as defined in COMAR 26.13.02.02 and:

(i) Exhibits one or more characteristics identified in COMAR 26.13.02.10—.14; or

(ii) Is listed in COMAR 26.13.02.15—.19.

(b) “Hazardous waste pharmaceutical” does not include:

(i) A pharmaceutical that will be legitimately used or reused by, for example, being lawfully donated for use for its intended purpose;

(ii) A pharmaceutical that is reclaimed, as described in COMAR 26.13.02.01D(7);

(iii) An over-the-counter pharmaceutical, dietary supplement, or homeopathic drug for which there is a reasonable expectation that the item will be legitimately used or reused by, for example, being lawfully redistributed for use for its intended purpose; or

(iv) An over-the-counter pharmaceutical, dietary supplement, or homeopathic drug for which there is a reasonable expectation that the item will be reclaimed.

(34-2) Healthcare Facility.

(a) “Healthcare facility” means any person that is legally authorized to:

(i) Provide preventative, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body;

(ii) Act as a provider of counseling, service, assessment, or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or

(iii) Distribute, sell, or dispense pharmaceuticals, including over-the counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals.

(b) “Healthcare facility” includes, but is not limited to:

(i) Wholesale distributors;

(ii) Third-party logistics providers that serve as forward distributors;

(iii) Military medical logistics facilities;

(iv) Hospitals, psychiatric hospitals, and ambulatory surgical centers;

(v) Health clinics and physicians’ offices;

(vi) Optical and dental providers;

(vii) Chiropractors;

(viii) Long-term care facilities;

(ix) Ambulance services;

(x) Pharmacies, long term-care pharmacies, mail-order pharmacies, and retailers of pharmaceuticals;

(xi) Veterinary clinics; and

(xii) Veterinary hospitals.

(c) “Healthcare facility” does not include:

(i) Pharmaceutical manufacturers;

(ii) Reverse distributors with respect to the receipt, accumulation, and processing of prescription pharmaceuticals for the purpose of facilitating or verifying manufacturer credit; or

(iii) Reverse logistics centers.

(34-3) “Household waste pharmaceutical” means a pharmaceutical that is a solid waste, as defined in COMAR 26.13.02.02, but is excluded from being a hazardous waste under COMAR 26.13.02.04-1A(1).

(35) — (48) (text unchanged)

(48-1) Long-term Care Facility.

(a) “Long-term care facility” means a licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility.

(b) “Long-term care facility” includes, but is not limited to, hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities.

(c) “Long-term care facility” does not include:

(i) A group home;

(ii) An independent living community;

(iii) An assisted living facility; or

(iv) The independent and assisted living portions of a continuing care retirement community.

(49) — (55-1) (text unchanged)

(55-2) Non-creditable Hazardous Waste Pharmaceutical.

(a) “Non-creditable hazardous waste pharmaceutical” means:

(i) A prescription hazardous waste pharmaceutical that does not have a reasonable expectation to be eligible for manufacturer credit; or

(ii) A nonprescription hazardous waste pharmaceutical that does not have a reasonable expectation to be reclaimed, legitimately used, or legitimately reused.

(b) “Non-creditable hazardous waste pharmaceutical” includes, but is not limited to:

(i) Investigational drugs;

(ii) Free samples of pharmaceuticals received by healthcare facilities;

(iii) Residues of pharmaceuticals remaining in empty containers;

(iv) Contaminated personal protective equipment;

(v) Floor sweepings; and

(vi) Cleanup material from the spills of pharmaceuticals.

(55-3) “Non-hazardous waste pharmaceutical” means a pharmaceutical that:

(a) Is a solid waste as defined in COMAR 26.13.02.02;

(b) Is not listed in COMAR 26.13.02.15—.19; and

(c) Does not exhibit any of the characteristics of hazardous waste identified in COMAR 26.13.02.10—.14.

(55-4) “Non-pharmaceutical hazardous waste” means a solid waste, as defined in COMAR 26.13.02.02, that is not a pharmaceutical, as defined in this section, and:

(a) Is listed in COMAR 26.13.02.15—.19; or

(b) Exhibits one or more of the characteristics of hazardous waste identified in COMAR 26.13.02.10—.14.

[(55-2)] (55-5) — [(55-3)] — (55-6) (text unchanged)

(56)—(62-1) (text unchanged)

(62-2) Pharmaceutical.

(a) “Pharmaceutical” means:

(i) A drug or dietary supplement for use by humans or other animals;

(ii) An electronic nicotine delivery system, such as an electronic cigarette or vaping pen; or

(iii) A liquid nicotine-containing product packaged for retail sale for use in electronic nicotine delivery systems, and including a pre-filled cartridge, pre-filled vial, or other packaging.

(b) “Pharmaceutical” includes, but is not limited to:

(i) A dietary supplement, as defined by the Federal Food, Drug and Cosmetic Act;

(ii) A prescription drug, as defined by 21 CFR §203.3(y);

(iii) An over-the-counter drug;

(iv) A homeopathic drug;

(v) A compounded drug;

(vi) An investigational new drug;

(vii) A pharmaceutical remaining in a nonempty container;

(viii) Personal protective equipment contaminated with a pharmaceutical; and

(ix) Clean-up material from a spill of a pharmaceutical.

(c) “Pharmaceutical” does not include dental amalgam or sharps.

(63) — (64) (text unchanged)

(64-1) Potentially Creditable Hazardous Waste Pharmaceutical.

(a) “Potentially creditable hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that:

(i) Has a reasonable expectation to receive manufacturer credit;

(ii) Is in original manufacturer packaging;

(iii) Is not a pharmaceutical that was subject to a recall;

(iv) Is undispensed; and

(v) Is unexpired or is less than 1 year past its expiration date.

(b) “Potentially creditable hazardous waste pharmaceutical” does not include:

(i) An evaluated hazardous waste pharmaceutical; or

(ii) Nonprescription pharmaceuticals including, but not limited to, over-the-counter drugs, homeopathic drugs, and dietary supplements.

[(64-1)] (64-2) (text unchanged)

(65) — (67) (text unchanged)

(67-1) Reverse Distributor.

(a) “Reverse distributor” means a person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit.

(b) “Reverse distributor” includes a forward distributor, a third-party logistics provider, a pharmaceutical manufacturer, or another person who processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit.

(68) — (73) (text unchanged)

(73-1) “Solvent-contaminated wipe” means a wipe that, after use or after cleaning up a spill, meets any of the following conditions:

(a) Contains one or more of the F001 through F005 solvents listed in COMAR 26.13.02.16A or the corresponding P- or U-listed solvents found in COMAR 26.13.02.19;

(b) Exhibits a hazardous characteristic found in COMAR 26.13.02.10—.14 if that characteristic results from a solvent listed in COMAR 26.13.02.15—.19; or

(c) Exhibits only the characteristic of ignitability found in COMAR 26.13.02.11 due to the presence of one or more solvents that are not listed in COMAR 26.13.02.15—.19.

(74) — (76) (text unchanged)

(76-1) Sump.

(a) "Sump" means, except as provided in §B(76-1)(b) of this regulation, any pit or reservoir that is a tank, and the troughs or trenches connected to it, that serves to collect hazardous waste for transport to hazardous waste storage, treatment, or disposal facilities.

(b) “Sump” means, in the context of regulations in this subtitle for landfills, surface impoundments, and waste piles, a lined pit or reservoir that serves to collect liquids drained from a leachate collection and removal system or leak detection system for subsequent removal from the system.

(77) — (89) (text unchanged)

(89-1) "Universal waste" means any of the following hazardous wastes that are managed under the universal waste requirements of COMAR 26.13.10.06—.25:

(a) (text unchanged)

(b) Pesticides as described in COMAR 26.13.10.08; [or]

(c) Mercury-containing equipment, lamps, or PCB-containing lamp ballasts, each as described in COMAR 26.13.10.09[.] ; or

(d) Aerosol cans as described in COMAR 26.13.10.09-1.

(89-2) Universal Waste Handler.

(a) "Universal waste handler" means:

(i) (text unchanged)

(ii) The owner or operator of a facility, including all contiguous property, that receives universal waste from other universal waste handlers, accumulates universal waste, and sends universal waste to another universal waste handler, a destination facility, or a foreign destination; [or]

(iii) A person that treats universal waste as described in COMAR 26.13.10.12, .14, or .15B(3)(c), including large quantity handlers as described in COMAR 26.13.10.20A, B, or D[.] ; or

(iv) A person that recycles universal waste under the provisions of COMAR 26.13.10.16-1, including large quantity handlers as described in COMAR 26.13.10.20F.

(b) "Universal waste handler" does not mean a:

(i) —(ii) (text unchanged)

(iii) Person that recycles universal waste, except for persons identified in §B(89-2)(a)(iv) of this regulation;

(iv) —(v) (text unchanged)

(89-3) — (95) (text unchanged)

(95-1) “Wipe” means a woven or non-woven shop towel, rag, pad, or swab made of wood pulp, fabric, cotton, polyester blends, or other material.

(96) (text unchanged)

.04 Rule-Making Petitions.

A. — K. (text unchanged)

L. Legitimate Recycling of Hazardous Secondary Materials.

(1) — (3) (text unchanged)

(4) Criteria to Be Considered Contained.

(a) For the purposes of this section, a hazardous secondary material is considered to be contained if the material is held in a unit, including a land-based unit, that meets the following criteria:

(i) — (iv) (text unchanged)

(v) The unit is operated so that only mutually compatible materials are placed in the unit; [and]

(vi) The materials being held in the unit are compatible with the materials of construction of the unit[.] ; and

(vi) The unit is designed and operated in a manner that addresses any potential risks of fires or explosions.

(b) (text unchanged)

.05 Incorporation by Reference.

A. (text unchanged)

B. Incorporation of Federal Regulations by Reference.

(1) As qualified by §B(2) of this regulation, certain federal regulations are incorporated by reference as follows:

(a) When used in COMAR 26.13.05, 40 CFR §§144.3 and 264.140—264.151 as of [July 1, 2019] July 1, 2024, are incorporated by reference;

(b) When used in COMAR 26.13.06, the federal regulations as of [July 1, 2019] July 1, 2024, in 40 CFR §§265.90—265.94, 265.140—265.148, 265.270—265.282, 265.340—265.351, 265.370—265.382, and 265.400—265.406 are incorporated by reference;

(c) When used in COMAR 26.13.01—26.13.10, [the federal regulations as of July 1, 2019, in 40 CFR Part 264,] Appendix IX of 40 CFR Part 264, as amended (Ground Water Monitoring List)[, 40 CFR Part 261, Appendix III Chemical Analysis Test Methods, and 49 CFR 173, 178, and 179 are] is incorporated by reference;

(d) When used in COMAR 26.13.03.07, the federal regulations as of [July 1, 2019] July 1, 2024, in 40 CFR §§262.81—262.89 are incorporated by reference;

(e) — (f) (text unchanged)

(g) When used in COMAR 26.13.02.17D, the federal regulations as of [July 1, 2020] July 1, 2024, in 40 CFR §261.32(d) are incorporated by reference;

(h) When used in COMAR 26.13.02.19-7, the federal regulations as of [July 1, 2020] July 1, 2024, in 40 CFR §261.39(a)(5) are incorporated by reference;

(i) When used in COMAR 26.13.02.19-8 the federal regulations as of [July 1, 2020] July 1, 2024, in 40 CFR §261.41 are incorporated by reference;

(j) When used in COMAR 26.13.03.05F(4), the federal regulations as of July 1, 2024, in 40 CFR §314(e) are incorporated by reference;

[(j)] (k) When used in COMAR 26.13.03.07, the federal regulations as of [July 1, 2020] July 1, 2024, in 40 CFR Part 262, Subpart H, are incorporated by reference;

[(k)] (l)When used in COMAR 26.13.05.02C(1), the federal regulations as of [July 1, 2020] July 1, 2024, in 40 CFR §264.12(a) are incorporated by reference;

(m) When used in COMAR 26.13.05.04G(4), 40 CFR Part 302, as amended, is incorporated by reference;

[(l)] (n) When used in COMAR 26.13.05.11, the federal regulations as of [July 1, 2020] July 1, 2024, in 40 CFR §§264.221(c)(2)(i)—(iv) and .223(b)—(d) are incorporated by reference;

[(m)] (o) When used in COMAR 26.13.05.12, the federal regulations as of [July 1, 2020] July 1, 2024, in 40 CFR §253(b) and (c) are incorporated by reference;

[(n)] (p) When used in COMAR 26.13.05.14, the federal regulations as of [July 1, 2020] July 1, 2024, in 40 CFR §§264.301(c)(3)(i)—(v), .301(c)(5), .303(c), and .304(b) are incorporated by reference;

[(o)] (q) When used in COMAR 26.13.06.19, the federal regulations as of [July 1, 2020] July 1, 2024, in 40 CFR §§265.222 and .223 are incorporated by reference;

[(p)] (r) When used in COMAR 26.13.06.20, the federal regulations as of [July 1, 2020] July 1, 2024, in 40 CFR §§265.254, .255, and .259 are incorporated by reference;

[(q)] (s) When used in COMAR 26.13.06.22, the federal regulations as of [July 1, 2020] July 1, 2024, in 40 CFR §§265.302 and .303 are incorporated by reference;

[(r)] (t) When used in COMAR 26.13.07.13-2A(13), the federal regulations as of [July 1, 2020] July 1, 2024, in Appendix I of 40 CFR §270.42 are incorporated by reference; [and]

[(s)] (u) Except as qualified by COMAR 26.13.09.03, when used in used in COMAR 26.13.01—26.13.10, the federal regulations as of [July 1, 2020] July 1, 2024, in 40 CFR Part 268 are incorporated by reference[.]; and

(v) When used in COMAR 26.13.10.49C, the federal regulations as of July 1, 2024, in 40 CFR §§266.510(a), (b)(1), b(2), b(4), c(1)—(4), and c(7)—(10) are incorporated by reference.

(2) References to Other Federal Regulations in Federal Regulations That Have Been Incorporated by Reference.

(a) (text unchanged)

(b) The following table lists federal regulations and the analogous provisions within the Code of Maryland Regulations:

40 CFR Provision Referenced	State of Maryland Analog to the Referenced 40 CFR Provision
§122.72(c). Note that, although there is a cross-reference to this citation in 40 CFR §265.276, it has been recodified. The current citation for this provision is 40 CFR §270.72(a)(3).	26.13.07.23C(1)(c)
§124.5 — Part 262, Subpart F (text unchanged)
Part 262, Subpart M	26.13.03.03-5C and D
§262.17(a)(7)	26.13.03.03-5B
§262.17(a)(7)(iv)	26.13.03.03-5B(1)(a)
262.11 — 262.20(e) (text unchanged)
§262.23(a)	26.13.03.04E(1)
§262.23(c) and (d) — §264.17(b) (text unchanged)
§264.72	26.13.05.05C
§264.73 — §265.21 (text unchanged)
§265.72	26.13.06.05A
§265.73 — §266.20(b) (text unchanged)
§266.500	26.13.01.03B
§266.502	26.13.10.37 – .45
§266.503	26.13.10.46
§266.508(a)	26.13.10.47A – E
§266.508(b)	26.13.10.47F
§266.509	26.13.10.48
§266.510	26.13.10.49
§266.510(a)	26.13.10.49C(1)(a)
§266.510(c)	26.13.10.49C(1)(c)
§266.510(c)(5)	26.13.10.47 and 26.13.10.49D(2)
§266.510(c)(6)	26.13.10.49D
Part 268	26.13.09
§270.14—§273.2 (text unchanged)

C. (text unchanged)

26.13.02 Identification and Listing of Hazardous Waste

Authority: Environment Article, §6-905.3 and Title 7, Subtitle 2, Annotated Code of Maryland

.01 Purpose and Scope.

A. (text unchanged)

B. In this chapter:

(1) Regulations .01—.07 define the terms "solid waste" and "hazardous waste", identify those wastes which are excluded from regulation under COMAR 26.13.03—26.13.07, 26.13.09, and 26.13.10 and establish special management requirements for hazardous waste produced by small quantity generators and hazardous waste which is used, re-used, recycled, or reclaimed.

(3) — (4) (text unchanged)

C. — D. (text unchanged)

.04 Materials Which Are Not Solid Wastes.

A. The following materials are not solid wastes for the purpose of this chapter:

(1) Domestic sewage, as defined in §B of this regulation, and, except as prohibited by COMAR 26.13.10.33 and Clean Water Act requirements at 40 CFR §403.4(b), any mixture of domestic sewage and other wastes that passes through a sewer system to a publicly owned treatment [work] works for treatment;

(2) — (16) (text unchanged)

(17) Petrochemical recovered oil from an associated organic chemical manufacturing facility that is to be inserted into the petroleum refining process (SIC code 2911) along with normal petroleum refining process streams, subject to the following:

(a) — (c) (text unchanged)

(d) Before the oil generated by the organic chemical manufacturing facility is recycled into the petroleum refining process, it is not:

(i) (text unchanged)

(ii) A material accumulated speculatively as defined in Regulation .01D of this chapter; [and]

(18) A used cathode ray tube (CRT) under the following conditions:

(a) — (c) (text unchanged)

(d) Glass removed from a CRT if it is managed in accordance with the requirements of Regulation .19-6D of this chapter[.]; and

(19) Beginning at the point of generation, a solvent-contaminated wipe that is sent for cleaning and reuse, if the following conditions are met:

(a) The wipe:

(i) Contains no free liquids, as determined by Method 9095B, the Paint Filter Liquids Test, included in “Test Methods for Evaluating Solid Waste, Physical/Chemical Methods”, EPA SW-846, which is incorporated by reference at COMAR 26.13.01.05A(4);

(ii) Contains no hazardous waste listed in Regulations .15—.19 of this chapter other than solvents; and

(iii) If it exhibits any of the characteristics of toxicity, corrosivity, or reactivity, does so only as a result of contamination by solvent contaminants, and not as a result of contamination by non-solvent contaminants;

(b) While being accumulated, stored, and transported, the wipe is contained in a nonleaking, closed container that is labeled “Excluded Solvent-Contaminated Wipes”;

(c) The container in which the wipe is placed:

(i) Is able to contain any free liquid that is expressed from materials in the container; and

(ii) Is kept closed except when it is necessary to open the container to add material, remove material, or examine the contents of the container, with closure of the container achieved by complete contact between a fitted lid of the container and the container rim;

(d) Each container that is being used to accumulate solvent contaminated wipes is marked with the earlier of the following dates as the accumulation start-date:

(i) The date on which the first solvent-contaminated wipe was placed in the container; or

(ii) If a wipe is transferred to the container from another container, the accumulation start-date associated with the container from which the wipe is being transferred;

(e) The wipe is sent for cleaning not later than 180 days after the accumulation start date associated with the container in which the wipe is being accumulated;

(f) The container in which the wipe is being accumulated is sealed, with all lids properly and securely affixed to the container, and all openings tightly bound or closed sufficiently to prevent leaks and emissions, if:

(i) The container is full;

(ii) Solvent-contaminated wipes that will be cleaned for reuse are no longer being generated; or

(iii) The container is being transported;

(g) At the point of being sent for cleaning on site, or at the point of being transported off site for cleaning:

(i) The wipe continues to contain no free liquids, as specified in §A(19)(a) of this regulation; and

(ii) The container in which the wipe has been placed contains no free liquid;

(h) The generator manages free liquids removed from solvent-contaminated wipes, and free liquid removed from a container in which a solvent contaminated wipe is being accumulated in accordance with applicable requirements of COMAR 26.13.01—26.13.10;

(i) The generator maintains the following documentation at the generator’s site:

(i) The name and address of the laundry or dry cleaner that is receiving the solvent-contaminated wipes;

(ii) Documentation that the 180-day accumulation time limit of §A(19)(e) of this regulation is being met; and

(iii) A description of the process that the generator is using to ensure that the solvent-contaminated wipes contain no free liquids at the point of being laundered or dry cleaned on site, or at the point of being transported off site for laundering or dry cleaning; and

(j) The solvent-contaminated wipe is sent to a laundry or dry cleaner whose discharge, if any, is regulated under §§301 and 402 of the Clean Water Act, or §307 of the Clean Water Act.

Agency Note: In rare circumstances, a facility that processes solvent-contaminated wipes for reuse may receive a container of wipes that includes free liquids, either unexpectedly as a result of effects such as compression, gravity, or percolation, or as a result of improper management by the generator before transport. In such circumstances, the processing facility is required to remove the free liquids from the solvent-contaminated wipes and the container, characterize the liquids as to whether they meet the definition of hazardous waste, and manage the liquids in accordance with the applicable requirements of COMAR 26.13.03. After removal of the free liquids, the facility may still process the wipes for reuse.

B. — C. (text unchanged)

.04-1 Solid Wastes Which Are Not Hazardous Wastes.

A. The following solid wastes are not hazardous wastes:

(1) — (14) (text unchanged)

(15) Used oil re-refining distillation bottoms that are used as feedstock to manufacture asphalt products; [and]

(16) Leachate or gas condensate collected from a landfill where certain solid wastes have been disposed if the following conditions are met:

(a) — (e) (text unchanged)

(f) The leachate or gas condensate is not regulated as a hazardous waste under §A-1 of this regulation[.]; and

(17) From the point of generation, a solvent-contaminated wipe that is sent for disposal or treatment if the wipe is not a hazardous waste due to the presence of trichloroethylene and the following conditions are met:

(a) The wipe:

(i) Contains no hazardous waste listed in Regulations .15—.19 of this chapter other than solvents; and

(ii) If it exhibits any of the characteristics of toxicity, corrosivity, or reactivity, does so only as a result of contamination by solvent contaminants, and not as a result of contamination by non-solvent contaminants;

(b) While being accumulated, stored, and transported, the wipe is contained in a nonleaking, closed container that is labeled “Excluded Solvent-Contaminated Wipes”;

(c) The container in which the wipe is placed:

(i) Is able to contain any free liquid that is expressed from materials in the container; and

(d) Each container that is being used to accumulate solvent contaminated wipes is marked with the earlier of the following dates as the accumulation start-date:

(i) The date on which the first solvent-contaminated wipe was placed in the container; or

(ii) If a wipe is transferred to the container from another container, the accumulation start-date associated with the container from which the wipe is being transferred;

(e) The wipe is sent for disposal or treatment not later than 180 days after the accumulation start date associated with the container in which the wipe is being accumulated;

(i) The container is full;

(ii) Additional solvent-contaminated wipes will not be placed in the container; or

(iii) The container is being transported;

(g) At the point of being transported for disposal or treatment:

(i) The wipe contains no free liquids, as specified in Regulation .04A(19)(a) of this chapter; and

(ii) The container in which the wipe has been placed contains no free liquid;

(i) The generator maintains the following documentation at the generator’s site:

(i) The name and address of the landfill or combustor that is receiving the solvent-contaminated wipes;

(ii) Documentation that the 180-day accumulation time limit of §A(17)(e) of this regulation is being met; and

(iii) A description of the process that the generator is using to ensure that the solvent-contaminated wipes contain no free liquids at the point of being transported off site for treatment or disposal;

(j) The wipe is sent for disposal or treatment to a:

(i) Landfill that is permitted, licensed, or registered by a state to manage municipal solid waste and is in compliance with the requirements of 40 CFR Part 258 or equivalent state regulations;

(ii) Landfill that is authorized to accept hazardous waste under a permit or interim status and that meets the applicable requirements for permitted and interim status hazardous waste landfills in 40 CFR Parts 264 and 265, or equivalent state regulations;

(iii) Municipal waste combustor or other facility regulated under Section 129 of the Clean Air Act; or

(iv) Combustor, boiler, or industrial furnace that is authorized to burn hazardous waste, and is operated in accordance with applicable requirements of 40 CFR Parts 264, 265, and 266 Subpart H, or equivalent state regulations.

A-1. — F. (text unchanged)

.04-7 Conditional Exemption for Collection of Airbag Waste.

A. This regulation:

(1) Applies to all airbag waste, as defined in COMAR 26.13.01.03B, collected from auto dealers or other airbag waste handlers for the purpose of safe disposal; and

(2) Provides management standards for airbag waste that an airbag waste handler may comply with as an alternative to managing airbag waste under other requirements of this subtitle that apply to management of hazardous waste generally.

B. Airbag waste at the airbag waste handler or during transport to an airbag waste collection facility or a designated facility is not subject to regulation under COMAR 26.13.03—.07 and .09, and is not subject to the notification requirements of §3010 of RCRA if:

(1) The airbag waste handler:

(a) In accumulating airbag waste:

(i) Accumulates no more than 250 items in its current inventory of waste airbag modules and waste airbag inflators; and

(ii) Does not accumulate any airbag waste for longer than 180 days;

(b) Meets the following requirements with respect to packaging the airbag waste:

(i) While the waste is being accumulated, ensures that the waste is packaged in a container that is designed to address the risks posed by the airbag waste, including reducing the risk of the airbag waste reacting in case of a fire, and reducing the risk of a projectile hazard if a defective airbag inflator were to deploy; and

(ii) Ensures that, before the airbag waste is offered for transport, the waste packaging meets U.S. Department of Transportation requirements for hazardous materials transportation;

(c) Ensures that each container in which airbag waste is being accumulated is:

(i) Marked with the earliest date on which accumulation began for the airbag waste within the container; and

(ii) Labeled with the words “Airbag Waste – Do Not Reuse”;

(d) Sends the airbag waste directly to either:

(i) An airbag waste collection facility in the United States that is under the control of a vehicle manufacturer or the authorized representative of a vehicle manufacturer;

(ii) An authorized party administering a remedy program in response to a recall under the National Highway Traffic Safety Administration; or

(iii) A “designated facility” as defined in COMAR 26.13.01.03B; and

(e) Complies with the record keeping requirements of §C of this regulation; and

(2) The transport of the airbag waste is conducted in compliance with all applicable U.S. Department of Transportation (DOT) regulations in 49 CFR Part 171—180 during transit.

C. Record Keeping.

(1) For each off-site shipment of airbag waste made under this regulation, an airbag waste handler shall maintain the following information and records at the handler facility for a minimum of 3 years:

(a) Name of the transporter;

(b) Date of the shipment;

(c) Name and address of the receiving facility;

(d) Types of airbag waste included in the shipment , such as airbag modules and airbag inflators;

(e) The quantity of each type of airbag waste in the shipment;

(f) Confirmation of receipt of the shipment that includes the:

(i) Information specified in §C(1)(c)—(e) of this regulation; and

(ii) Date that the receiving facility received the shipment.

(2) The airbag waste handler:

(a) May satisfy the record keeping requirements of this section through the use of routine business records, such as electronic or paper financial records, bills of lading, copies of DOT shipping papers, and electronic or paper confirmation of receipt; and

(b) Shall make the shipping information and records and the confirmations of receipt required by this section available for inspection by a representative of the Department or the U.S. Environmental Protection Agency upon request.

D. Requirements Applicable to Airbag Waste Received from an Airbag Waste Handler.

(1) Upon arrival at an airbag waste collection facility or a designated facility, airbag waste from an airbag waste handler operating under this regulation becomes subject to all applicable hazardous waste regulations.

(2) For airbag waste identified in §D(1) of this regulation, the facility receiving the airbag waste:

(a) Is considered the generator of the airbag waste; and

(b) Shall comply with all applicable requirements of COMAR 26.13.03 with respect to that waste.

E. Prohibition on Reuse. A person may not reuse in a vehicle a defective airbag module or a defective airbag inflator that is subject to a recall under the National Highway Traffic Safety Administration. An attempt to reuse the defective item in this manner constitutes sham recycling and is prohibited by COMAR 26.13.02.02H.

.05 Special Requirements for Hazardous Waste Generated by Small Quantity Generators.

A. Exemptions.

(1) (text unchanged)

(2) In determining quantities under this chapter and COMAR 26.13.03, a generator shall include all hazardous waste generated, except for hazardous waste that is:

(a) — (e) (text unchanged)

(f) Universal waste managed under Regulation .07-1 of this chapter and COMAR 26.13.10.06—.25; [or]

(g) Managed as part of an episodic generation event in compliance with the requirements of COMAR 26.13.03.05-2—26.13.03.05-4[.]; or

(h) A hazardous waste pharmaceutical, as defined in COMAR 26.13.01.03B, that is:

(i) Subject to or managed in accordance with COMAR 26.13.10.32—.49; or

(ii) Also a Drug Enforcement Administration controlled substance and is conditionally exempt under COMAR 26.13.10.34.

B. — C. (text unchanged)

D. In order for hazardous waste to be excluded from regulation under this chapter, the generator:

(1) (text unchanged)

(2) Shall treat or dispose of the waste in an on-site facility, or ensure delivery to an off-site treatment, storage, or disposal facility, either of which, if located in the United States, is:

(a) — (f) (text unchanged)

(g) For universal waste managed under COMAR 26.13.10.06—.25, a universal waste handler or destination facility subject to the requirements of COMAR 26.13.10.06—.25; [or]

(h) A facility that is under the control of the same person as the generator, as described in COMAR 26.13.03.03—11B(1), if the generator marks the generator's containers of hazardous waste in accordance with the requirements of COMAR 26.13.03.03—10A(1) and (2), and the facility is authorized to accept the waste from the generator for consolidation under the provisions of:

(i) (text unchanged)

(ii) 40 CFR §262.14(a)(5)(viii) or analogous regulations of the destination state, as applicable, if the facility to which the waste is being sent is not located in Maryland; [and]

(i) A reverse distributor as defined in COMAR 26.13.01.03B, if the waste is a potentially creditable hazardous waste generated by a healthcare facility as defined in COMAR 26.13.01.03B;

(j) For a non-creditable hazardous waste pharmaceutical or a potentially creditable hazardous waste pharmaceutical, a healthcare facility, as defined in COMAR 26.13.01.03B, if:

(i) The generator meets the applicability requirements in COMAR 26.13.10.36A; and

(ii) The receiving healthcare facility meets the conditions in COMAR 26.13.10.36C(1); or

(k) For airbag waste, an airbag waste collection facility or a designated facility subject to Regulation .04-7 of this chapter;

(3) May not accumulate hazardous waste on-site if the generator accumulates at any time:

(a) (text unchanged)

(b) More than a total of 100 kilograms of any hazardous waste not otherwise regulated under §D(3)(a) of this regulation, in which case, those accumulated wastes are subject to regulation under COMAR 26.13.03—26.13.07 and 26.13.10 and the applicable notification requirements of §3010 of RCRA, and the time period of COMAR 26.13.03.03—4C for accumulation of wastes on-site begins for a generator when the initial waste is generated[.]; and

(4) May not place or arrange to have placed bulk or non-containerized liquid hazardous waste or hazardous waste containing free liquids in a landfill regardless of whether sorbents have been added.

E. — G. (text unchanged)

.06 Requirements for Recyclable Materials.

A. (text unchanged)

A-1. Exclusions.

(1) The following recyclable materials are not CHS for purposes of the regulations indicated:

(a) Industrial ethyl alcohol that is reclaimed is not a CHS for purposes of COMAR 26.13.03—26.13.09, except that:

(i) [exports] Exports and imports are subject to the requirements of 40 CFR Part 262, Subpart H, as made applicable in COMAR 26.13.03.07 ;

(ii) A person initiating a shipment for reclamation in a foreign country, and any intermediary arranging for the shipment, shall comply with the requirements of §B(2) of this regulation; and

(iii) A transporter transporting a shipment for export shall comply with the requirements of §B(3) of this regulation.

(b) — (c) (text unchanged)

(2) The following recyclable materials are not subject to regulation under COMAR 26.13.03—26.13.07 and are not subject to the regulations indicated, 40 CFR Part 268, or the notification requirements of §3010 of RCRA:

(a) Industrial ethyl alcohol that is reclaimed is not subject to COMAR 26.13.03—26.13.07, except for the requirements specified in [§D] §A-1(1)(a)(i) of this regulation;

(b) — (e) (text unchanged)

(3) (text unchanged)

B. Generators and Transporters.

(1) Generators and transporters of recyclable materials are subject to the applicable requirements of COMAR 26.13.03—26.13.04 and the notification requirements under §3010 of RCRA, except as provided in §§A(2) and A-1 of this regulation.

(2) A person initiating a shipment of industrial ethyl alcohol for reclamation in a foreign country, and any intermediary arranging for the shipment:

(a) Shall comply with the requirements applicable to a primary exporter in 40 CFR §§262.83(b), 262.83(g)(1)—(4) and (6), and 262.84(h); and

(b) May export such materials only upon consent of the receiving country and in conformance with the EPA Acknowledgment of Consent as defined in 40 CFR Part 262 Subpart H; and

(c) Shall provide a copy of the EPA Acknowledgment of Consent to the transporter transporting the shipment for export.

(3) A transporter transporting a shipment of industrial ethyl alcohol for export:

(a) May not accept a shipment if the transporter knows the shipment does not conform to the EPA Acknowledgment of Consent; and

(b) Shall ensure that a copy of the EPA Acknowledgment of Consent:

(i) Accompanies the shipment; and

(ii) Is delivered to the facility designated by the person initiating the shipment.

C. Storage of Recyclable Materials.

(1) (text unchanged)

(2) Owners or operators of facilities that recycle recyclable materials without storing them before they are recycled are subject to the following requirements, except as provided in §A(1) of this regulation:

(a) Notification requirements under §3010 of RCRA; [and]

(b) COMAR 26.13.05.05B and C[.]; and

(c) Biennial reporting requirements of COMAR 26.13.05.05F.

.07 Residues of Hazardous Waste in Empty Containers.

A. (text unchanged)

B. Definition of Empty.

(1) [A] Except as provided in §B(2)—(4) of this regulation, a container or an inner liner removed from a container that has held any hazardous waste[, except a waste that is compressed gas or that is identified in Regulations .16—.19 of this chapter as an acute hazardous waste,] is empty if all wastes have been removed that can be removed using the practices commonly employed to remove materials from that type of container, such as pouring, pumping, and aspirating, and either:

(a) — (b) (text unchanged)

(2) — (3) (text unchanged)

(4) A container that held a hazardous waste pharmaceutical or that contains a residue of a hazardous waste pharmaceutical is empty if it meets the criteria specified in COMAR 26.13.10.35.

.07-1 Requirements for Universal Waste.

A. Except as specified in COMAR 26.13.10.06—.25, the wastes listed in §B of this regulation are exempt from regulation under COMAR 26.13.03—26.13.07, COMAR 26.13.09, and COMAR 26.13.10.01—.05, and, therefore, are not fully regulated as hazardous waste.

B. The following wastes are subject to regulation under COMAR 26.13.10.06—.25:

(1) (text unchanged)

(2) Pesticides, as described in COMAR 26.13.10.08; [and]

(3) Mercury-containing equipment, lamps, or PCB-containing lamp ballasts, each as described in COMAR 26.13.10.09[.] ; and

(4) Aerosol cans, as described in COMAR 26.13.10.09-1.

.11 Characteristic of Ignitability.

A. A solid waste exhibits the characteristic of ignitability if a representative sample of the waste has any of the following properties:

(1) [It] Except as provided in §A-1 of this regulation, it is a liquid[, other than an aqueous solution containing less than 24 percent alcohol by volume, and] that has a flash point less than 60°C (140°F), as determined by[:] using one of the methods specified in 40 CFR §261.21(a)(1);

[(a) A Pensky-Martens Closed Cup Tester, using the test method specified in ASTM Standard D-93-79, or D-93-80;

(b) A Setaflash Closed Cup Tester, using the test method specified in ASTM Standard D-3278-78; or

(2) — (4) (text unchanged)

A-1. A liquid that is an alcohol-containing solution that contains less than 24 percent alcohol by volume and at least 50 percent water by weight is not considered to exhibit the characteristic of ignitability under §A(1) of this regulation.

B. (text unchanged)

C. For the purposes of this regulation:

(1) — (2) (text unchanged)

(3) A compressed gas shall be characterized as ignitable if any of the following criteria are met:

(a) — (b) (text unchanged)

(i) The] the compressed gas meets the definition of "flammable gas (Division 2.1)" under 49 CFR §173.115(a) and [(k)] (l);

[(ii) Using the test procedure with the Bureau of Explosives' Flame Projection Apparatus described in Regulation .11-1 of this chapter, the flame projects more than 18 inches beyond the ignition source with the valve opened fully, or the flame flashes back and burns at the valve with any degree of valve opening;

(iii) Using the test procedure with the Bureau of Explosives' Open Drum Apparatus described in Regulation .11-1 of this chapter, there is any significant propagation of flame away from the ignition source; or

(iv) Using the test procedure with the Bureau of Explosives' Closed Drum Apparatus described in Regulation .11-1 of this chapter, there is any explosion of the vapor-air mixture in the drum;]

(4) (text unchanged)

(5) "Organic peroxide":

(a) (text unchanged)

(b) Does not include a material that:

(i) Meets the definition of a [Class A or Class B explosive, as described in Regulation .13C of this chapter] Division 1.1, 1.2, or 1.3 explosive, as defined in 49 CFR §173.50 and 49 CFR §173.53, in which case the material is classed as an explosive;

(ii) — (iv) (text unchanged)

[Agency Note: ASTM Standards are available from ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA, 19428.]

.13 Characteristic of Reactivity.

A. A solid waste exhibits the characteristic of reactivity if a representative sample of the waste has any of the following properties:

(1) — (7) (text unchanged)

(8) It is a:

(a) (text unchanged)

(b) [Class A explosive or a Class B explosive as determined under §C of this regulation] Division 1.1, 1.2, or 1.3 explosive as defined in 49 CFR §173.50 and 173.53.

B. (text unchanged)

[C. To determine if a waste explosive is a Class A explosive or a Class B explosive, a person shall:

(1) Determine the division number for the explosive under 49 CFR §173.50; and

(2) Consult 49 CFR §173.53 to determine the class name for the waste under the U.S. Department of Transportation classification system that was in effect before January 1, 1991.]

.16 Hazardous Waste from Nonspecific Sources.

A. As qualified by §§B and D of this regulation, the solid wastes listed in the “Hazardous Waste” column of Table 1 of this regulation are listed as hazardous wastes from nonspecific sources unless they are excluded under:

(1) — (2) (text unchanged)

(3) Section C or D of this regulation:

TABLE 1 Hazardous Waste from Nonspecific Sources

Industry	EPA Hazardous Waste Number	Hazardous Waste	Hazard Code
Generic	F001 — F012 (text unchanged)
	[F014	Cyanidation wastewater treatment tailing pond sediment from mineral metals recovery operations	(T)
	F015	Spent cyanide bath solutions from mineral metals recovery operations	(R ,T)]
	F019 — F039 (text unchanged)

B. — D. (text unchanged)

.19 Discarded Commercial Chemical Products, Off-Specification Species, Containers, and Spill Residues of These.

The following materials or items are hazardous wastes if and when they are discarded or intended to be discarded as described in Regulation .02A(2)(a) of this chapter, when they are mixed with waste oil or used oil or other material and applied to the land for dust suppression or road treatment, when they are otherwise applied to the land instead of their original intended use or when they are contained in products that are applied to the land instead of their original intended use or when, instead of their original intended use, they are produced for use as (or as a component of) a fuel, distributed for use as a fuel, or burned as a fuel:

A. — B. (text unchanged)

C. Any residue remaining in a container or inner liner removed from a container that has been used to hold any commercial chemical product or manufacturing chemical intermediate having the generic name listed in §E, F, G, or H of this regulation unless the container or inner liner is empty as defined in Regulation .07B of this chapter or as specified in COMAR 26.13.10.35.

D. — F. (text unchanged)

G. The commercial chemical products, manufacturing chemical intermediates, or off-specification commercial chemical products, referred to in §§A—D of this regulation, are identified as toxic wastes (T) unless otherwise designated and are subject to the small quantity exclusion defined in Regulation .05A and C of this chapter. These wastes and their corresponding EPA Hazardous Waste Numbers are:

Hazardous Waste Number	Substance*
	A2213 see U394
U001 — U201 (text unchanged)
[U202	Saccharin and salts]
U203 — U411 (text unchanged)

* Agency note: the Department has included in this table those trade names of which the Department was aware. An omission of a trade name does not imply that a waste commercial chemical product having that name is not hazardous. The material is hazardous if it is listed under its generic name.

H. (text unchanged)

.23 Basis for Listing Hazardous Wastes.

EPA Hazardous Waste Number	Hazardous Constituents For Which Listed
F001 — F012	(text unchanged)
[F014	cyanide (complexed)
F015	cyanide (salts)]
F019 — F038	(text unchanged)
F039	All constituents for which treatment standards are specified for multi-source leachate, both wastewaters and nonwastewaters, under 40 CFR [§268.43(a)] §268.43, Table CCW
K001 — K181	(text unchanged)

26.13.03 Standards Applicable to Generators of Hazardous Waste

Authority: Environment Article, Title 7, Subtitle 2, Annotated Code of Maryland

.01 Purpose, Scope, and Applicability.

A. — A-1. (text unchanged)

A-2. [A] Except as provided in §§J—L of this regulation, a person is subject to the requirements of this chapter if the person meets any of the following criteria:

(1) — (4) (text unchanged)

A-3. — F. (text unchanged)

G. A generator of hazardous waste who treats, stores, or disposes hazardous waste on-site shall comply with the applicable standards and permit requirements of COMAR 26.13.05, 26.13.06, [and] 26.13.07, and 26.13.09, but may be exempted from certain of these requirements under Regulation .03-4 of this chapter.

H. — J. (text unchanged)

K. A reverse distributor, as defined in COMAR 26.13.01.03B, is subject to COMAR 26.13.10.32—.49 instead of this chapter for the management of hazardous waste pharmaceuticals.

L. A healthcare facility, as defined in COMAR 26.13.01.03B:

(1) Shall determine whether the healthcare facility is subject to the provisions of COMAR 26.13.10.32—.49 for the management of hazardous waste pharmaceutical based on:

(a) The total hazardous amount of waste that the healthcare facility generates each calendar month, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste; and

(b) The criteria in COMAR 26.13.10.32E and F; and

(2) Shall, if the healthcare facility is a very small quantity generator under federal regulations, as described in COMAR 26.13.03.01-1B, when counting all of the hazardous waste it generates in a calendar month, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste, refer to COMAR 26.13.10.32D(1)(c) and (d) to determine the applicable requirements for managing the generator’s hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste.

.01-1 Federally-defined Hazardous Waste Generator Categories — Applicability in Maryland.

A. — B. (text unchanged)

B-1. Federal Generator Categories — Healthcare Facilities that Generate Hazardous Waste Pharmaceuticals. To determine the applicable federally-defined hazardous waste generator category, a healthcare facility as defined in COMAR 26.13.01.03B shall refer to COMAR 26.13.10.32F

C. — D. (text unchanged)

.02 Hazardous Waste Determination — Generator's Obligations.

A. — B. (text unchanged)

C. If the result of the determination required by §A of this regulation is that the waste is a hazardous waste, the generator of the waste shall refer to COMAR 26.13.02, 26.13.05, 26.13.06, 26.13.09, and 26.13.10 for possible exclusions or restrictions pertaining to management of the specific waste.

D. (text unchanged)

.03-3 Satellite Accumulation Areas.

A. — D. (text unchanged)

E. Management Standards.

(1) (text unchanged)

(2) Container Standards.

(a) The generator shall use a container made of or lined with materials that will not react with, and are otherwise compatible with, the hazardous waste to be accumulated, so that the ability of the container to contain the waste is not impaired.

[(2)] (b) (text unchanged)

[(a)] (i)— [(b)] (ii) (text unchanged)

(3) — (5) (text unchanged)

(6) The generator shall ensure that the satellite accumulation area is operated in accordance with the:

(a) [preparedness] Preparedness and prevention requirements of Regulation .03-5C of this chapter[.]; and

(b) Contingency plan and emergency procedure requirements of Regulation .03-5D and E of this chapter.

.03-4 Accumulation of Hazardous Waste — Exemption from Permit Requirement.

A. — B. (text unchanged)

C. Limits on Time of Accumulation of Hazardous Waste. A person may accumulate a hazardous waste on site for no more than 90 days, unless:

(1) — (2) (text unchanged)

(3) The waste is being managed in a container or a tank by a person who qualifies for an additional 90 days of accumulation time under the provisions of §D(2) of this regulation, for a maximum accumulation limit of 180 days, by being a person who:

(a) Either:

(i) Meets the federal definition of a small quantity generator; or

(ii) Does not qualify as a Maryland-defined small quantity generator under Regulation .01A-3(1) of this chapter, and meets the federal definition of a very small quantity generator;

(b) (text unchanged)

(c) Does not receive hazardous waste from an off-site [Maryland-defined small quantity] generator under the provisions of Regulation .03-11 of this chapter;

(4) — (5) (text unchanged)

D. — E. (text unchanged)

.03-5 General Requirements for Persons Accumulating Hazardous Waste.

A. — B. (text unchanged)

C. Preparedness and Prevention.

(1) Except as provided in §C(2) of this regulation, a person subject to this regulation:

(a) Shall:

(i) [ensure] Ensure that, for each area at a site where hazardous waste is generated or accumulated, the requirements of COMAR 26.13.05.03 for preparedness and prevention at a hazardous waste facility are met; and

(ii) Maintain records documenting arrangements made with local emergency response agencies required by COMAR 26.13.05.03H, or, in cases where such arrangements do not exist, documenting attempts that were made to make such arrangements; and

(b) (text unchanged)

(2) (text unchanged)

D. — F. (text unchanged)

.03-7 Requirements for Accumulation of Hazardous Waste in Tanks.

A. (text unchanged)

B. A person subject to this regulation shall:

(1) Comply with the requirements of:

(a) — (b) (text unchanged)

(c) COMAR 26.13.05.10-4[, except that the generator may not seek a variance from the requirements of COMAR 26.13.05.10-4 under the provisions of COMAR 26.13.05.10-5]; and

(d) (text unchanged)

(2) — (3) (text unchanged)

(4) Use inventory logs, monitoring equipment, or other records to demonstrate that:

(a) If using a batch process, hazardous waste has been emptied within 90 days of first entering the tank or by an alternate deadline established under Regulation .03-4C(1) or C(3) of this chapter; and

(b) If using a continuous flow process, the volumes of hazardous waste that are estimated to be entering the tank each day are exiting the tank within 90 days of first entering the tank or by an alternate deadline established under Regulation .03-4C(1) or C(3) of this chapter;

(5) — (7) (text unchanged)

.05 Pretransport Requirements.

A. — E. (text unchanged)

F. Liquids in Landfills Prohibition.

(1) A person may not place or arrange to have placed bulk or non-containerized liquid hazardous waste or hazardous waste containing free liquids in a landfill.

(2) The prohibition of §F(1) of this regulation applies regardless of whether sorbents have been added to the waste.

(3) To demonstrate the absence or presence of free liquids, a person shall use Method 9095, Paint Filter Liquids Test, as described in "Test Methods for Evaluating Solid Waste, Physical/Chemical Methods", EPA Publication SW-846, which is incorporated by reference in COMAR 26.13.01.05A(4).

(4) A person may not use a sorbent to eliminate free liquids from a waste that is to be disposed of in a landfill unless the sorbent meets the requirements of 40 CFR §264.314(d).

.05-4 Episodic Generation Events — Maryland-Defined Small Quantity Generators.

A. — B. (text unchanged)

C. Management Standards.

(1) A Maryland-defined small quantity generator managing hazardous waste from an episodic generation event:

(a) May accumulate the waste in a:

(i) (text unchanged)

(ii) Tank, if the requirements of §C(4) of this regulation are met; [and]

(b) May not accumulate the waste in a drip pad or in a containment building[.]; and

(c) Shall manage the waste in a manner that minimizes the possibility of a fire, explosion, or release of hazardous waste or hazardous waste constituents to the air, soil, or water.

(2) — (4) (text unchanged)

(5) [Manifest] Requirements — Manifests, Record Keeping, and Reporting. The generator shall comply with the:

(a) [hazardous] Hazardous waste manifest provisions of Regulation .04 of this chapter and applicable provisions of 40 CFR Part 262 Subpart B when the generator sends hazardous waste from an episodic event off site to a designated facility as defined in COMAR 26.13.01.03B[.];

(b) Record keeping requirements of Regulations .06A(1), (3), and (4) of this chapter;

(c) Exception reporting requirements of Regulation .06C(2) of this chapter; and

(d) Additional reporting requirements of Regulation .06D of this chapter.

(6) (text unchanged)

.06 Record Keeping and Reporting.

A. (text unchanged)

B. Annual or Biennial Reporting.

(1) — (2) (text unchanged)

(3) Information on exports of hazardous waste is not required to be included in the report required by §B(1) and (2) of this regulation. Instead, exporters of hazardous waste shall comply with the annual reporting requirements [of Regulation .07-2C of this chapter] that are established by 40 CFR §262.83(g) and administered by EPA, as specified in Regulation .07B of this chapter.

(4) — (5) (text unchanged)

C. — D. (text unchanged)

26.13.04 Standards Applicable to Transporters of Hazardous Waste

Authority: Environment Article, Title 7, Subtitle 2, Annotated Code of Maryland

.01 General.

A. — C. (text unchanged)

D. Mixing.

(1) — (2) (text unchanged)

(3) Mixing does not include the blending, mingling, combining, or putting together of waste within but not among the following categories of hazardous waste from the same or different sources provided the substances are chemically and physically compatible:

(a) — (b) (text unchanged)

(c) Cyanides [(]with [the following] EPA Hazardous Waste Numbers[)—] F007, F008, F009, F010, F011, F013, [F014, F015,] or F016, or all of these;

(d) — (e) (text unchanged)

(4) (text unchanged)

(5) When consolidating the contents of two or more containers with the same hazardous waste into a new container, or when combining and consolidating two different hazardous wastes that are compatible with each other, the transporter shall do the following for each container of 119 gallons or less that is being used to hold the consolidated waste:

(a) Mark the container with the words “Hazardous Waste”; and

(b) Either:

(i) Mark the container with each applicable EPA hazardous waste number (EPA hazardous waste code) identified in COMAR 26.13.02.10—.19; or

(ii) Use the method specified in COMAR 26.13.03.05C(3) to satisfy the requirement to mark the container with the EPA hazardous waste numbers of the wastes in the container.

E. — F. (text unchanged)

26.13.05 Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities

Authority: Environment Article, Title 7, Subtitle 2, Annotated Code of Maryland

.01 General.

A. Purpose, Scope, and Applicability.

(1) — (2) (text unchanged)

(3) The requirements of this chapter do not apply to:

(a) — (c) (text unchanged)

(d) A generator accumulating waste on-site in compliance with:

(i) COMAR 26.13.03.03-3—.03-10, except to the extent that a provision in COMAR 26.13.03.03-3—.03-10 requires the generator to comply with the requirements in this chapter; or

(ii) COMAR 26.13.03.05-3—.05-5;

(e) — (j) (text unchanged)

(k) Universal waste handlers and universal waste transporters handling the following wastes:

(i) (text unchanged)

(ii) Pesticides, as described in COMAR 26.13.10.08; [and]

(iii) Lamps, mercury-containing equipment, or PCB-containing lamp ballasts, each as described in COMAR 26.13.10.09; [or] and

(iv) Aerosol cans, as described in COMAR 26.13.10.09-1; or

(l) A person who operates a device to crush mercury-containing lamps if the person who operates the device is in compliance with the requirements of COMAR 26.13.10.15B(3)[.]; or

(m) A reverse distributor accumulating potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals, as defined in COMAR 26.13.01.03B.

Agency Note: Reverse distributors are subject to regulation under COMAR 26.13.10.32—.49 instead of this chapter for the accumulation of potentially creditable hazardous waste pharmaceuticals and evaluated pharmaceuticals.

B. — D. (text unchanged)

.04 Contingency Plan and Emergency Procedures.

A. — F. (text unchanged)

G. Emergency Procedures.

(1) — (3) (text unchanged)

(4) If the emergency coordinator determines that the facility has had a release, fire, or explosion which could threaten human health, or the environment, outside the facility, or if the release is of a quantity which would exceed the Reportable Quantities listed in 40 CFR Part 302, [as promulgated effective July 1, 2007,] the emergency coordinator shall report these findings as follows:

(a) — (b) (text unchanged)

(5) — (10) (text unchanged)

.05 Manifest System, Record Keeping, and Reporting.

A. — B. (text unchanged)

C. Manifest Discrepancies.

(1) Manifest discrepancies are:

(a) — (b) (text unchanged)

(c) Container residues, which are residues that exceed the quantity limits for a container to be defined as "empty" under COMAR 26.13.02.07B and 26.13.10.35.

(2) — (8) (text unchanged)

D. Operating Record.

(1) (text unchanged)

(2) The owner or operator shall record the following information as it becomes available, and maintain it in the operating record until closure of the facility:

(a) — (b) (text unchanged)

(i) — (ii) (text unchanged)

(d) — (g) (text unchanged)

(h) Monitoring, testing, or analytical data, and corrective action when required by Regulations .06—.06-7, .10D, .10-2, .10-4, .11D-2, .11D-3, .11F, .12D-1, .12D-2, .12E, .13G, [I, K,] .13I, .13K, .14C, .14E, .14F, [I] .14I, .16I, and .16-1C of this chapter;

(i) — (p) (text unchanged)

E. — H. (text unchanged)

.14 Landfills.

A. — M. (text unchanged)

N. Special Requirements for Liquid Waste.

(1) Liquids in Landfills Prohibition.

[(1)](a) A person may not place waste which contains free liquids in a landfill, including bulk waste, non-containerized waste, or waste in containers.

(b) The prohibition of §N(1)(a) of this regulation applies regardless of whether sorbents have been added to the waste.

(2) (text unchanged)

(3) A person may not use a sorbent to eliminate free liquids from a waste that is to be disposed of in a landfill unless the sorbent meets the requirements of 40 CFR §264.314(d).

O. — P. (text unchanged)

26.13.06 Interim Status Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities

Authority: Environment Article, Title 7, Subtitle 2, Annotated Code of Maryland

.01 General.

A. Purpose, Scope, and Applicability.

(1) — (3) (text unchanged)

(4) The requirements of this chapter do not apply to:

(a) — (i) (text unchanged)

(j) Universal waste handlers and universal waste transporters handling the following wastes:

(i) (text unchanged)

(ii) Pesticides, as described in COMAR 26.13.10.08; [and]

(iii) Lamps, mercury-containing equipment, or PCB-containing lamp ballasts, each as described in COMAR 26.13.10.09; [or] and

(iv) Aerosol cans, as described in COMAR 26.13.10.09-1; or

(k) The addition of absorbent material to a waste container or the addition of waste to absorbent in a container, if:

(i) — (iii) (text unchanged)

(iv) COMAR 26.13.05.09C, which concerns compatibility of waste with containers, is complied with[.]; or

(l) A reverse distributor accumulating potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals, as defined in COMAR 26.13.01.03B.

(5) — (7) (text unchanged)

B. — C. (text unchanged)

.02 General Facility Standards.

A. — D. (text unchanged)

E. An owner or operator shall ensure that the inspection schedule required in §D of this regulation includes, at a minimum, the items and frequencies called for in:

(1) — (4) (text unchanged)

(5) 40 CFR §§265.278, 265.347, 265.377, and [265.402] 265.403, which are incorporated by reference in Regulations .21A, .23A, .24A, and .25A of this chapter, respectively.

F. — H. (text unchanged)

.05 Manifest System, Record Keeping, and Reporting.

A. (text unchanged)

B. For the purpose of complying with this regulation, the owner or operator of a facility subject to this chapter shall:

(1) In place of the requirement of COMAR 26.13.05.05D(2)(c), record and maintain in the operating record the results of waste analyses, waste determinations, and trial tests performed as specified in:

(a) — (c) (text unchanged)

(d) COMAR 26.13.05.12C, with which the owner or operator is required to comply in Regulation .20B(2) of this chapter; [and]

(e) 40 CFR §§265.273, 265.341, 265.375, and 265.402, which are incorporated by reference in Regulations .21A, .23B, .24A, and .25A of this chapter, respectively; and

(f) As qualified by COMAR 26.13.09.03B, 40 CFR §268.4(a) and 40 CFR §268.7.

(2) — (5) (text unchanged)

C. (text unchanged)

.22 Landfills.

A. —E-2. (text unchanged)

F. Special Requirements for Liquid Wastes and Containers.

(1) Liquids in Landfills Prohibition.

[(1)](a) (text unchanged)

(b) The prohibition of §F(1)(a) of this regulation applies regardless of whether sorbents have been added to the waste.

(c) A person may not use a sorbent to eliminate free liquids from a waste that is to be disposed of in a landfill unless the sorbent meets the requirements of 40 CFR §264.314(d).

(2) — (3) (text unchanged)

26.13.07 Permits for CHS Facilities

Authority: Environment Article, Title 1, Subtitle 6 and Title 7, Subtitle 2, Annotated Code of Maryland

.01 Permit Required.

A. — E. (text unchanged)

[F. Incorporation by Reference. 40 CFR §§264.140—264.151, as promulgated as of July 1, 2007, are incorporated by reference.]

.02 Application for a Permit.

A. — C-1 (text unchanged)

D. Permit Information. All applicants, using an application format acceptable to the Department, shall provide the following information to the Secretary:

(1) — (39) (text unchanged)

(40) For hazardous debris that the facility will manage, a description of each debris category and each contaminant category to be treated, stored, or disposed of at the facility.

(41) For a land disposal facility, if a case-by-case extension has been approved under 40 CFR §268.5 or a petition has been approved under 40 CFR §268.6, a copy of the notice of approval for the extension or petition.

E. (text unchanged)

.02-6 Specific Information Requirements for Incinerators.

A. — B. (text unchanged)

C. If the permit applicant does not submit a trial burn plan or the results of a trial burn under §B(2) of this regulation, the permit applicant shall submit the following information:

(1) An analysis, using the analytical techniques specified in [40 CFR Part 261, Appendix III, which is incorporated by reference in COMAR 26.13.01.05B(1)(c)] COMAR 26.13.02.22, of each waste or mixture of wastes to be burned including:

(a) — (d) (text unchanged)

(e) An approximate quantification of the hazardous constituents identified in the waste, within the precision produced by the analytical methods specified in [40 CFR Part 261, Appendix III] COMAR 26.13.02.22; and

(f) (text unchanged)

(2) — (8) (text unchanged)

D. (text unchanged)

.17 Hazardous Waste Incinerator Permits.

A. (text unchanged)

B. Trial Burn.

(1) — (2) (text unchanged)

(3) The trial burn plan shall include the following information:

(a) An analysis of each waste or mixture of wastes to be burned which includes:

(i) — (ii) (text unchanged)

(iii) An identification of any hazardous organic constituents listed in COMAR 26.13.02.24 which are present in the waste to be burned, except that the applicant need not analyze for constituents listed in COMAR 26.13.02.24 which would reasonably not be expected to be found in the waste. The constituents excluded from analysis shall be identified, and the basis for their exclusion stated. The waste analysis shall rely on analytical techniques specified in [40 CFR Part 261, Appendix III] COMAR 26.13.02.22.

(iv) — (vi) (text unchanged)

(b) — (h) (text unchanged)

(4) — (12) (text unchanged)

C. — D. (text unchanged)

.20 Administrative Procedures — Permit Applications and Modifications.

A. (text unchanged)

B. Modifications, Revocation and Reissuance, or Termination of Permits.

(1) (text unchanged)

(2) Denial of Request.

(a) If the Secretary decides that a request made under §B(1)(c) of this regulation is not justified, the Secretary shall send the requester a brief written response giving a reason for the decision [and shall offer an opportunity for a contested case hearing, in accordance with Maryland's Administrative Procedure Act, State Government Article, §10-201 et seq., Annotated Code of Maryland, and the procedures in Regulation .20-5B of this chapter].

(b) (text unchanged)

(c) A denial of a request constitutes a final permit decision of the Secretary and is subject to judicial review under Regulation .20-5B of this chapter.

(3) Tentative Decision to Modify or Revoke and Reissue.

(a) If the Secretary tentatively decides to modify or revoke and reissue a permit under Regulation .11 of this chapter, the Secretary shall prepare a [draft permit] tentative determination under Regulation .20-1A of this chapter, which shall include a draft permit incorporating the proposed changes.

(b) The Secretary may request additional information when evaluating the potential modification, revocation and reissuance, or termination of a permit and, in the case of a modified permit, may require the submission of an updated permit application.

(4) — (6) (text unchanged)

(7) Judicial Review. A final decision to modify, revoke and reissue, or terminate a permit is subject to judicial review under Regulation .20-5B of this chapter.

.20-1 Administrative Procedures—Tentative and Final Determinations.

A. Tentative Determinations and Draft Permits.

(1) — (3) (text unchanged)

(4) Draft Permits—General.

(a) — (b) (text unchanged)

(c) [An appeal of the] The final decision [may be made in accordance with Maryland Administrative Procedure Act, State Government Article, §10-201 et seq., Annotated Code of Maryland, by following the procedures in Regulation .20-6C(3) of this chapter] is subject to judicial review under Regulation .20-5B of this chapter.

(5) (text unchanged)

B. — C. (text unchanged)

D. Administrative Record for Draft Permits.

(1) (text unchanged)

(2) For preparing a draft permit under §A of this regulation, the record shall consist of:

(a) — (b) (text unchanged)

(c) The statement of basis [or fact sheet] under §B of this regulation or the fact sheet under §C of this regulation;

(d) — (e) (text unchanged)

(3) (text unchanged)

[(4) This section applies to all draft permits for which public notice was given after January 31, 1983.]

[(5)] (4) (text unchanged)

(5) Public Availability of Information—Tentative Determination.

(a) Except as provided in §D(5)(b) of this regulation, the Department shall, not later than the date of publication of a notice of tentative determination under Regulation .20-2A of this chapter, make available for inspection and copying:

(i) The permit application on which the tentative determination is based;

(ii) Documents that were submitted with the permit application;

(iii) All documents that the Department relied on in making the tentative determination; and

(iv) The privilege log developed under §D(5)(c) of this regulation

(b) The requirements of §D(5)(a) of this regulation do not apply to materials that have been designated confidential business information, documents for which disclosure is precluded by law, or documents that are subject to privilege.

(c) The Department shall compile a privilege log that:

(i) Identifies all documents not made available for inspection and copying under §D(5)(b) of this regulation; and

(ii) States the reasons for withholding each document identified in the log.

E. Final Determination.

(1) The Department shall prepare a final determination if:

(a) Written comments adverse to the tentative determination were received by the Department within [45 days after the publication of the notice of tentative determination] during the comment period established for the tentative determination;

(b) — (c) (text unchanged)

(d) The final determination is substantively different from the tentative determination [and all persons aggrieved by the final determination have not waived, in writing, their right to request a contested case hearing].

(2) Notice of Final Determination.

[(2)](a) If the Department is required to prepare a final determination under §E(1) of this regulation, the Department shall publish a notice of the final determination in accordance with the requirements of Regulation .20-2 of this chapter.

(b) If the final determination differs substantively from the tentative determination, the Department shall, before publishing notice of the final determination under §E(2)(a) of this regulation:

(i) Publish notice of intent to issue a final determination that includes a proposed final determination and provides the opportunity for written public comment for a period of at least 30 days on the portion of the proposed final determination that differs substantively from the tentative determination;

(ii) Consider all public comments submitted on the proposed final determination during the public comment period; and

(iii) Prepare written responses to public comments submitted on the proposed final determination during the public comment period, and provide a copy of the written responses to persons who submitted the comments.

(3) Final Decision.

(a) The final determination made by the Department under §E(1) of this regulation or, if applicable, under the process established in §E(2) of this regulation, constitutes the Department’s final decision.

[(3)] (b) If the Department is not required to prepare a final determination under §E(1) of this regulation, the tentative determination [is] becomes a final decision by the Department when the permit is issued or denied.

.20-2 Administrative Procedures—Public Notices of Permit Actions and Public Comment Period.

A. The Secretary shall give public notice [that] of the following[ actions have occurred]:

(1) (text unchanged)

(2) A draft permit has been prepared and a tentative determination has been made to issue the draft permit;

(3) [Public hearings or informational meetings have] An informational meeting has been scheduled;

(4) [An appeal has been granted] A public hearing has been scheduled;

(5) (text unchanged)

(6) An application to modify a CHS permit under Regulation .11 of this chapter has been received by the Department; [and]

(7) A final determination has been prepared under Regulation .20-1E of this chapter[.] ;

(8) The Department intends to issue a final determination that differs substantively from a tentative determination, in accordance with Regulation .20-1E(2)(b) of this chapter; and

(9) The Department has reopened a comment period under Regulation .20-4C of this chapter.

B. — C. (text unchanged)

D. Timing.

(1) — (4) (text unchanged)

(5) The Secretary:

(a) Shall extend the comment period established under §D(1) of this regulation for an additional 60 days if the Secretary receives a written request to do so from any person during the original comment period provided;

(b) May not extend the comment period under §D(5)(a) of this regulation more than once; and

(c) May establish a longer comment period to the extent that the Secretary determines that the longer comment period is necessary.

E. Methods.

(1) Except as provided in §E(2) of this regulation, the Secretary shall give public notice of activities described in §A of this regulation by mailing a copy of a notice to the following persons:

(a) — (c) (text unchanged)

(d) Persons on a mailing list developed by:

(i) — (ii) (text unchanged)

(iii) Notifying the public of the opportunity to be put on the mailing list through periodic publication in the public press or on the Department’s website and in such publications as regional and State funded newsletters, environmental bulletins, or State law journals;

(e) Any unit of local government having jurisdiction over the area where the facility is proposed to be located; [and]

(f) Each State agency having any authority under State law with respect to the construction and operation of the facility[.] ;

(g) Any person who submitted written comments during the public comment period; and

(h) Any person who submitted oral or written comments at a public hearing conducted under Regulation .20-5A of this chapter and who provided the Department with a legible mailing address when signing in at the hearing.

(2) — (6) (text unchanged)

(7) Electronic Posting.

(a) Notice of Receipt of Application. The Department shall:

(i) Post on the Department’s website the notice of receipt of an application for a CHS facility permit under §A(5) of this regulation, and the notice of receipt of an application for modification of a CHS facility permit under §A(6) of this regulation; and

(ii) Provide a method for interested persons to electronically request any additional notices related to an application for a permit identified in §E(7)(a)(i) of this regulation.

(b) Final Determination. The Department shall post on the Department’s website notice that a tentative determination has become a final determination.

F. Public Notices—Content.

(1) — (3) (text unchanged)

(4) Public Notices of Final Determination. In addition to the information required to be contained in public notices by §F(1) of this regulation, the public notice of a final determination under Regulation .20-1E(1) of this chapter shall include reference to the right to judicial review in accordance with Environment Article §1-601(a), Annotated Code of Maryland.

.20-3 Administrative Procedures—Informational Meetings on Permit Applications.

A. — B. (text unchanged)

C. Presentation of Information Concerning an Application.

(1) The Department may require the applicant to attend an informational meeting[,] or public hearing, [or contested case hearing] and present information concerning the application.

(2) (text unchanged)

.20-4 Administrative Procedures—Public Comments.

A. (text unchanged)

B. Obligation to Raise Issues and Provide Information During the Public Comment Period.

(1) — (3) (text unchanged)

(4) Because a comment period longer than 45 days will often be necessary in complicated proceedings to give commenters a reasonable opportunity to comply with the requirements of this regulation:

(a) (text unchanged)

(b) The Secretary shall freely establish longer comment periods under Regulation .20-2 of this chapter to the extent they appear necessary and as required by Regulation 20-2D(5) of this chapter.

C. Reopening of the Public Comment Period.

(1) If any data, information, or arguments submitted during the public comment period, including information or arguments required under §B of this regulation appear to raise substantial new questions concerning a permit, the Secretary may take one or more of the following actions:

(a) Prepare a new draft permit, appropriately modified, and prepare a new tentative determination under Regulation .20-1A of this chapter;

(b) — (c) (text unchanged)

(2) If the comment period is reopened under §C(1)(c) of this regulation, the Secretary shall:

(a) (text unchanged)

(b) Assure that public notice for the reopening of the public comment period issued according to Regulation .20-2 of this chapter defines the scope of the reopening.

(3) — (4) (text unchanged)

D. Response to Comments.

(1) At the time that any final permit is issued, the Secretary shall:

(a) Issue a response to comments, including a response to any comments on a proposed final determination submitted in accordance with Regulation .20-1E(2)(b) of this chapter; and

(b) (text unchanged)

(2) The Secretary shall include in the administrative record for the final permit decision:

(a) All materials in the administrative record for the draft permit under Regulation .20-1D of this chapter; and

(b) [all] All new materials supplied during the public comment period, new points raised, and documents cited in the response to comments.

(3) — (4) (text unchanged)

.20-5 Administrative Procedures—Hearings and Judicial Review.

A. Public Hearings.

(1) — (2) (text unchanged)

(3) Hearing Limitations and Extension of Comment Period.

(a) Any person may submit oral or written statements and data concerning the tentative determination or the draft permit at the public hearing.

(b) — (d) (text unchanged)

(4) — (5) (text unchanged)

[B. Contested Case Hearings.

(1) Applicability. This section applies to permits to own, operate, establish, or maintain a CHS facility issued pursuant to Environment Article, §7-232, Annotated Code of Maryland.

(2) A person may request a contested case hearing to appeal a final determination issued by the Department under Regulation .20-1E of this chapter if the person makes factual allegations with sufficient particularity to demonstrate that:

(a) The person is aggrieved by the final determination; and

(b) The final determination is:

(i) Legally inconsistent with any provisions of law applicable to the final determination being challenged; or

(ii) Based on an incorrect determination of a relevant and material fact.

(3) A person requesting a contested case hearing shall submit a written request for adjudication within 15 days after publication of a notice of final determination.

(4) A person requesting adjudication shall assure that the request sets forth the basis for the request with sufficient particularity to demonstrate that:

(a) The issues to be raised are within the scope of §B(2) of this regulation; and

(b) The person is aggrieved by the final determination.

(5) Challenging Compliance with Zoning and Land Use Requirements.

(a) Except as provided in §B(5)(b) of this regulation, a person may not, in a contested case hearing, challenge a facility's compliance with zoning and land use requirements or conformity with a county plan issued under Environment Article, Title 9, Subtitle 5, Annotated Code of Maryland.

(b) The provisions of §B(5)(a) of this regulation do not prevent a person from:

(i) Challenging whether the Department has complied with Environment Article, §§2-404(b)(2)(ii) and 9-210(a)(3), Annotated Code of Maryland, when applicable; or

(ii) Contesting the compliance of a facility with zoning and land use or county plan requirements in any proceeding brought in accordance with and under any applicable local laws.

(6) A contested case hearing shall be conducted in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.

(7) Summary Disposition. The Secretary shall comply with the provisions of Environment Article, §1-606, Annotated Code of Maryland, concerning summary disposition of a request for a contested case hearing.]

B. Judicial Review.

(1) A person may file a petition for judicial review of a final permit decision on the issuance, denial, renewal, modification, or revocation and reissuance of a CHS facility permit under Environment Article, §7-232, Annotated Code of Maryland, if the person:

(a) Meets threshold requirements for standing under federal law; and

(b) Either:

(i) Is the applicant; or

(ii) Participated in the public participation process through the submission of written or oral comments, unless an opportunity for public participation was not provided.

(2) The record on review and the objections considered during judicial review shall be limited in accordance with the provisions of Environment Article, Title 1, Subtitle 6, Annotated Code of Maryland.

(3) Venue.

(a) Unless otherwise provided by statute, a person who is filing a petition for judicial review of a final permit decision under §B(1) of this regulation shall file the petition with the circuit court for the county where the application for the permit states that the proposed activity will occur.

(b) The decision of the circuit court may be appealed to the Appellate Court of Maryland.

(4) A person submitting a petition for judicial review of a final permit decision shall file the petition within 30 days after publication of notice of a final determination in accordance with Regulation .20-2A(7) of this chapter.

.20-6 Administrative Procedures—Issuance and Effective Date of Permits.

A. After the close of the public comment period on a draft permit under Regulation .20-2 of this chapter, or the close of the public comment period on a notice of intent to issue a final determination under Regulation .20-1E(2)(b) of this chapter the Secretary shall:

(1) Issue a final permit decision in accordance with Regulation .20-1E(3) of this chapter;

(2) (text unchanged)

(3) Include in the [notice] notification required by §A(2) of this regulation reference to the procedures for [appealing a decision on a] petitioning for judicial review on a final permit decision [or for contesting a decision to terminate a permit].

B. [For]“Final permit decision” means, for the purposes of this regulation, [a final permit decision means] a final decision to issue, deny, modify, revoke and reissue, or terminate a permit.

C. A final permit decision shall become effective 30 days after the service of notice of the decision under §A of this regulation, unless:

(1) A later effective date is specified in the decision; or

[(2) The permit is within the scope of Environment Article, Title 1, Subtitle 6, Annotated Code of Maryland, and a person requests a contested case hearing under Environment Article, §1-605, Annotated Code of Maryland; or]

[(3)] (2) (text unchanged)

26.13.09 Land Disposal Restrictions

Authority: Environment Article, Title 7, Subtitle 2, Annotated Code of Maryland

.01 Purpose and Scope.

[A. ]This chapter:

[(1)] A. (text unchanged)

[(2)] B. Applies to:

[(a)] (1) (text unchanged)

[(b)] (2) Transporters of hazardous waste; [and]

[(c)] (3) (text unchanged)

(4) Reverse distributors; and

[(3)] C. Does not apply to a hazardous waste that is listed in COMAR 26.13.02.16—.19 but is not listed in 40 CFR §§261.30—261.34, unless the waste:

[(a)] (1)— [(b)] (2) (text unchanged)

26.13.10 Standards for the Management of Specific Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities

Authority: Environment Article, §6-905.3 and Title 7, Subtitle 2, Annotated Code of Maryland

.01 Recyclable Materials Used in a Manner Constituting Disposal.

A. Applicability.

(1) — (2) (text unchanged)

(3) Except as provided in §A(4) and (5) of this regulation, products produced for the general public's use that are used in a manner that constitutes disposal and that contain recyclable materials are not presently subject to regulation if:

(a) The recyclable materials have undergone a chemical reaction in the course of producing the product so as to become inseparable by physical means; [and]

(b) For each recyclable material, that is, hazardous waste, that the product contains, the product meets the applicable:

(i) (text unchanged)

(ii) Prohibition levels in 40 CFR §268.32 or RCRA §3004(d), if no treatment standards have been established under 40 CFR Part 268, Subpart D[.] ; and

(c) The recycler complies with the requirements of 40 CFR §268.7(b)(6), either directly or, if located in Maryland, as qualified by COMAR 26.13.09.03B.

(4) — (5) (text unchanged)

B. — C. (text unchanged)

D. Standards Applicable to Users of Materials That Are Used in a Manner That Constitutes Disposal.

(1) Owners or operators of facilities that use recyclable materials in a manner that constitutes disposal are regulated under all applicable provisions of COMAR 26.13.02, 26.13.05, 26.13.06, [and] 26.13.07, and 26.13.09 and §3010 of RCRA, except that these requirements do not apply to products which contain these recyclable materials under the provisions of §A(3) of this regulation.

(2) (text unchanged)

.04 Spent Lead-Acid Batteries Being Reclaimed.

A. — I. (text unchanged)

J. Requirements — Exports of Batteries That Will Be Reclaimed. Persons who export batteries to be reclaimed through regeneration or any other means in a foreign country are:

(1) Exempt from the following requirements with respect to those batteries:

(a) COMAR 26.13.03, except for COMAR 26.13.03.02, which concerns hazardous waste determination; and

(b) (text unchanged)

[(c) The notification requirements of §3010 of RCRA; and]

(2) (text unchanged)

K. (text unchanged)

.06 Scope — Standards for Universal Waste Management.

This regulation and Regulations .07—.25 of this chapter:

A. (text unchanged)

B. Include standards for managing the following:

(1) (text unchanged)

(2) Pesticides, as described in Regulation .08 of this chapter; [and]

(3) (text unchanged)

(4) Aerosol cans, as described in Regulation .09-1 of this chapter; and

C. (text unchanged)

.08 Applicability — Pesticides.

A. Except for pesticides identified in §B of this regulation, or as otherwise specified in §B of this regulation, the requirements of Regulations .06—.25 of this chapter apply to persons managing pesticides, as defined in COMAR 26.13.01.03B, meeting the following conditions:

(1) — (2) (text unchanged)

B. [The] Except as otherwise noted in this section, the requirements of Regulations .06—.25 of this chapter do not apply to management of the following pesticides:

(1) (text unchanged)

(2) [Pesticides] Except for a pesticide in an aerosol can as defined in COMAR 26.13.01.03, pesticides not meeting the conditions of §A of this regulation, which shall instead be managed in compliance with the hazardous waste regulations in COMAR 26.13.01—26.13.10.05;

(3) A pesticide in an aerosol can as defined in COMAR 26.13.01.03 that does not meet the conditions of §A of this regulation, which shall be managed either:

(a) As aerosol can universal waste in compliance with:

(i) Regulation .16-1 of this chapter or Regulation .20F of this chapter; and

(ii) All other applicable requirements of Regulations .06—.25 of this chapter; or

(b) In compliance with the hazardous waste regulations in COMAR 26.13.01—26.13.10.05

[(3)](4)—[(4)](5) (text unchanged)

C.—D. (text unchanged)

.09-1 Applicability — Aerosol Cans.

A. Except for aerosol cans identified in §B of this regulation, the requirements of Regulations .06—.25 of this chapter apply to persons managing aerosol cans as defined in COMAR 26.13.01.03B.

B. The requirements of Regulations .06—.25 of this chapter do not apply to the management of an aerosol can that:

(1) Is not yet waste under COMAR 26.13.02, including an aerosol can that does not meet the criteria for waste generation in §C of this regulation;

(2) Does not meet the criteria of §D of this regulation to be regulated as hazardous waste; or

(3) Qualifies as an empty container under the provisions of COMAR 26.13.02.07B.

C. Generation of Waste Aerosol Cans.

(1) A used aerosol can becomes a waste on the date the can is discarded, with "discarded" being defined by the criteria of COMAR 26.13.02.02A(2).

(2) An unused aerosol can becomes a waste on the date the handler decides to discard the can.

D. Criteria to be Regulated as Hazardous Waste. An aerosol can is regulated as hazardous waste if the aerosol can:

(1) Exhibits one or more of the characteristics of hazardous waste identified in COMAR 26.13.02.10—.14;

(2) Contains a substance listed in COMAR 26.13.02.15—.19; or

(3) Otherwise meets the definition of hazardous waste in COMAR 26.13.02.03.

E. Voluntary Management. A person managing an aerosol can excluded under §B of this regulation may voluntarily elect to manage the aerosol can in accordance with the provisions of Regulations .06—.25 of this chapter.

.14 Small Quantity Handlers of Universal Waste Mercury-Containing Equipment — Specific Management Standards.

A. (text unchanged)

B. A small quantity handler of universal waste:

(1)—(2) (text unchanged)

(3) May remove mercury-containing ampules from universal waste mercury-containing equipment, if the handler:

(a)—(c) (text unchanged)

(d) Immediately transfers any mercury resulting from spills or leaks from broken ampules from the containment device required by §B(3)(b) of this regulation to a container that meets [the requirements of COMAR 26.13.03.03-3—.03-10] and is managed in accordance with all applicable requirements of COMAR 26.13.01—26.13.10;

(e) — (h) (text unchanged)

(4) — (6) (text unchanged)

.16-1 Small Quantity Handlers of Universal Waste Aerosol Cans — Specific Management Standards.

A. A small quantity handler of universal waste shall manage universal waste aerosol cans in a way that prevents any releases of universal waste or a component of universal waste to the environment.

B. A small quantity handler of universal waste shall:

(1) Accumulate universal waste aerosol cans in a container that is:

(a) Structurally sound;

(b) Compatible with the contents of the aerosol cans;

(c) Lacking evidence of:

(i) Leakage;

(ii) Spillage; or

(iii) Damage that could cause leakage under reasonably foreseeable conditions; and

(d) Protected from sources of heat;

(2) Manage a universal waste aerosol can that show evidence of leakage by:

(a) Packaging the aerosol can in a separate closed container;

(b) Overpacking the aerosol can in a container with absorbents; or

(c) Immediately puncturing and draining the aerosol can in accordance with the requirements of §D of this regulation.

C. A small quantity handler of universal waste may conduct the following activities if each individual aerosol can is not breached and remains intact:

(1) Sorting aerosol cans by type;

(2) Commingling intact aerosol cans in one container; and

(3) Removing actuators to reduce the risk that an accidental release will occur.

D. A small quantity handler of universal waste aerosol cans who punctures and drains a universal waste aerosol can shall:

(1) Recycle the empty punctured aerosol can;

(2) Conduct puncturing and draining activities using a device specifically designed to:

(a) Safely puncture aerosol cans; and

(b) Effectively contain the residual contents from the punctured can and any related emissions;

(3) Establish and follow a written procedure that specifies how to safely puncture and drain the universal waste aerosol can, including details about the following topics:

(a) Proper assembly, operation, and maintenance of the device used for the activity;

(b) Segregation of incompatible wastes generated; and

(c) Proper waste management practices to prevent fires and releases;

(4) Maintain, on site, a copy of the manufacturer’s operating instructions and specifications for the device that is being used for puncturing and draining;

(5) Ensure that persons performing puncturing and draining activities are trained in the proper procedures for conducting the activities.

(6) Ensure that puncturing of the can is done in a manner that:

(a) Is designed to prevent fires and prevent the release of any component of universal waste to the environment; and

(b) In addition to other appropriate measures to satisfy the requirements of §D(6(a) of this regulation, includes locating the puncturing equipment on a solid, flat surface in a well-ventilated area;

(7) Immediately transfer the contents from the waste aerosol can or puncturing device, if applicable, to a container or tank that meets the applicable requirements in:

(a) COMAR 26.13.02.05;

(b) COMAR 26.13.03.03-3; or

(c) COMAR 26.13.03.03-4 —.03-11, .05E, .05-1, and .05-2;

(8) Conduct a hazardous waste determination in accordance with the requirements of COMAR 26.13.03.02—.02-2 on:

(a) The contents emptied from the aerosol can;

(b) The punctured, drained aerosol can if the aerosol can does not meet the criteria of COMAR 26.13.02.07B to be considered “empty”; and

(c) Any other solid waste generated in connection with the puncturing and draining of the aerosol can;

(9) Manage any hazardous waste generated as a result of puncturing and draining the aerosol can in accordance with all applicable requirements of COMAR 26.13.01—.10, with the universal waste handler being considered the generator of the hazardous waste and subject to the requirements of COMAR 26.13.03;

(10) Manage nonhazardous waste generated as a result of puncturing and draining the aerosol can in accordance with applicable State, federal, and local solid waste regulations; and

(11) Satisfy the following requirements concerning emergency preparedness and response:

(a) Have in place a written procedure on how to respond in the event of a spill or leak to minimize risks to human health and the environment;

(b) Have a spill cleanup kit readily available; and

(c) Promptly clean up any spill or leak of the contents of an aerosol can.

.17 Small Quantity Handlers of Universal Waste — General Management Standards.

A. Labeling and Marking.

(1) (text unchanged)

(2) A small quantity handler of universal waste shall:

(a)—(f) (text unchanged)

(g) Clearly label or mark each universal waste aerosol can that is not in a container, and each container in which universal waste aerosol cans are being held with one of the following phrases:

(i) “Universal Waste—Aerosol Can(s)”;

(ii) “Waste Aerosol Can(s)”; or

(iii) “Used Aerosol Can(s)

(3) (text unchanged)

B. — D. (text unchanged)

.19 Large Quantity Handlers of Universal Waste — General Requirements.

A.—B. (text unchanged)

C. Notification.

(1) Except as provided in §C(2) of this regulation, a large quantity handler of universal waste, before accumulating 5,000 kilograms of universal waste for the first time, shall:

(a) Send to the Secretary a written notification that includes the following information:

(i)—(iii) (text unchanged)

(iv) A list of all the types of universal waste managed by the handler, such as "batteries, pesticides, mercury-containing equipment, aerosol cans, and lamps"; and

(v) (text unchanged)

(b) (text unchanged)

(2) (text unchanged)

.20 Large Quantity Handlers of Universal Waste — Specific Management Standards.

A.—E. (text unchanged)

F. Universal Waste Aerosol Cans. A large quantity handler of universal waste shall manage universal waste aerosol cans in accordance with the requirements established for small quantity handlers in Regulation .16-1 of this chapter.

.25 Petitions to Include Other Wastes as Universal Wastes.

A. General Requirements.

(1) [A] Except as provided in §C of this regulation, a person seeking to add a hazardous waste or a category of hazardous waste to the universal waste regulations of [COMAR 26.13.10.06—.25] Regulations .06—.25 of this chapter may petition for a regulatory amendment under this regulation and COMAR 26.13.01.04A and J.

B. (text unchanged)

C. Hazardous waste pharmaceuticals are regulated by Regulations .32—.49 of this chapter and may not be added to the universal waste regulations of Regulations .06—.25 of this chapter as a category of universal waste.

.32 Hazardous Waste Pharmaceuticals — General Provisions.

A. Scope. This regulation and Regulations .33—.49 of this chapter:

(1) Establish requirements for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors; and

(2) Identify certain pharmaceuticals that are excluded from regulation under COMAR 26.13.01—.10.

B. Defined Terms. The following terms used in this regulation and Regulations .33—.49 of this chapter have the meaning stated in COMAR 26.13.01.03B:

(1) “Evaluated hazardous waste pharmaceutical”;

(2) “Hazardous waste pharmaceutical”;

(3) “Healthcare facility”;

(4) “Household waste pharmaceutical”;

(5) “Long-term care facility”;

(6) “Non-creditable hazardous waste pharmaceutical”;

(7) “Non-hazardous waste pharmaceutical”;

(8) “Non-pharmaceutical hazardous waste”;

(9) “Pharmaceutical”;

(10) “Potentially creditable hazardous waste pharmaceutical”; and

(11) “Reverse distributor”.

C. Excluded Materials and Wastes.

(1) Except as specified in this section, the following pharmaceuticals are not subject to regulation under COMAR 26.13.01—26.13.10:

(a) A pharmaceutical that is not a solid waste, as defined in COMAR 26.13.02.02, because the pharmaceutical is to be:

(i) Reclaimed; or

(ii) Legitimately used or legitimately reused, such as by being lawfully donated for use for the pharmaceutical’s intended purpose;

(b) An over-the-counter pharmaceutical, a dietary supplement, or a homeopathic drug that is not a solid waste, as defined in COMAR 26.13.02.02, because:

(i) The material is going to be reclaimed; or

(ii) There is a reasonable expectation that the material will be legitimately used or legitimately reused, such as by being lawfully redistributed for use for its intended purpose;

(c) A pharmaceutical that is being managed in accordance with a recall strategy that has been approved by the U.S. Food and Drug Administration (FDA) in accordance with 21 CFR Part 7, Subpart C, except that this regulation and Regulations .33—.49 of this chapter apply to the management of the recalled hazardous waste pharmaceutical after the FDA approves the destruction of the recalled pharmaceutical;

(d) A pharmaceutical that is being managed in accordance with a recall corrective action plan that has been accepted by the U.S. Consumer Product Safety Commission (CPSC) in accordance with 16 CFR Part 1115, except that this regulation and Regulations .33—.49 of this chapter apply to the management of the recalled hazardous waste pharmaceutical after the CPSC approves the destruction of the recalled pharmaceutical;

(e) A pharmaceutical that is being stored during an investigation, during a judicial proceeding, or according to a preservation order until either:

(i) The investigation, judicial proceeding, or preservation order has concluded, and a decision is made to discard the pharmaceutical; or

(ii) A decision is made to discard the pharmaceutical before the investigation, judicial proceeding, or preservation order has concluded;

(f) An investigational new drug for which an investigational new drug application is in effect in accordance with the FDA’s regulations in 21 CFR Part 312, except that this regulation and Regulations .33—.49 of this chapter apply to the management of the drug if:

(i) The drug, if discarded, would meet the definition of hazardous waste; and

(ii) A decision has been made to discard the investigational new drug, or the FDA has approved the destruction of the investigational new drug; and

(g) A household waste pharmaceutical, including a household waste pharmaceutical that has been collected by an authorized collector as defined by the U.S. Drug Enforcement Administration if the authorized collector complies with the conditional exemption in Regulations .34A(2) and B of this chapter.

(2) The residue of a hazardous waste pharmaceutical that remains in a stock container, dispensing container, unit dose container, syringe, or intravenous bag that is empty according to the criteria in Regulation .35 of this chapter is not regulated as hazardous waste.

D. Excluded Facilities.

(1) A healthcare facility that is a very small quantity generator under federal regulations, as described in COMAR 26.13.03.01-1B, when counting all of the hazardous waste it generates in a calendar month, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste:

(a) Is subject to:

(i) Regulation .33 of this chapter, which prohibits the discharge of hazardous waste pharmaceuticals to sewer systems that discharge to publicly owned treatment works; and

(ii) Regulation .35 of this chapter, which concerns residues of hazardous waste pharmaceuticals in empty containers;

(b) Has the option of complying with the requirements of §E(3) of this regulation for the management of the facility’s hazardous waste pharmaceuticals, as an alternative to managing the hazardous waste pharmaceuticals in accordance with COMAR 26.13.02.05 and the optional provisions of Regulation .36 of this chapter;

(c) Unless the facility voluntarily elects to manage hazardous waste pharmaceuticals in accordance with the regulations specified in §E(3) of this regulation:

(i) Shall manage the hazardous waste pharmaceuticals it generates in accordance with COMAR 26.13.02.05;

(ii) May comply with the optional provisions of Regulation .36 of this chapter; and

(iii) Is not subject to the requirements of §E(3) of this regulation; and

(d) Shall manage the non-pharmaceutical hazardous waste it generates in accordance with:

(i) COMAR 26.13.03 if the amount of non-pharmaceutical hazardous waste accumulated by the facility prevents the facility from being classified as a Maryland-defined small quantity generator, as specified in COMAR 26.13.03.01A-3(1); or

(ii) COMAR 26.13.02.05 if the amount of non-pharmaceutical hazardous waste accumulated by the facility allows the facility to be classified as a Maryland-defined small quantity generator.

(2) A long-term care facility with 20 beds or fewer:

(a) Is presumed to be a very small quantity generator under federal regulations with respect to all of the hazardous waste it generates in a calendar month, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste, unless the Department is able to demonstrate otherwise; and

(b) Shall comply with §D(1) of this regulation unless the Department demonstrates that the facility does not qualify as a very small quantity generator under federal regulations, taking into account both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste, in which case the facility shall comply with the requirements of §§E(3) and E(4) of this regulation.

E. Applicability — Healthcare Facilities and Management of Hazardous Waste Pharmaceuticals.

(1) Based on the criteria specified in COMAR 26.13.03.01-1B, a healthcare facility is subject to the requirements specified in §E(3) of this regulation if, in a calendar month:

(a) The facility:

(i) Meets the criteria to be classified as a federally-defined large quantity generator or a federally-defined small quantity generator based on the amount of non-pharmaceutical hazardous waste generated in a calendar month; and

(ii) Generates any quantity of hazardous waste pharmaceuticals;

(b) The facility:

(i) Meets the criteria to be classified as a very small quantity generator under federal regulations, counting only the non-pharmaceutical hazardous waste generated by the facility; and

(ii) Generates a quantity of hazardous waste pharmaceuticals that exceeds the criteria to be classified as a very small quantity generator under federal regulations, taking into account only the hazardous waste pharmaceuticals generated by the facility; or

(c) The total amount of hazardous waste that the facility generates, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste, exceeds the criteria to be classified as a very small quantity generator under federal regulations.

(2) §F of this regulation provides a summary, in a tabular format, of the criteria specified in §E(1) of this regulation.

(3) A healthcare facility identified in §E(1) of this regulation is subject to the following instead of COMAR 26.13.02—26.13.06 in managing hazardous waste pharmaceuticals:

(a) Regulations .33—.35, .37—.45, and .47 of this chapter with respect to the management of:

(i) Non-creditable hazardous waste pharmaceuticals; and

(ii) Potentially creditable hazardous waste pharmaceuticals if they are not destined for a reverse distributor; and

(b) Regulations .33—.35, .37, .38, .46, and .48 of this chapter with respect to the management of potentially creditable hazardous waste pharmaceuticals that are prescription pharmaceuticals and are destined for a reverse distributor.

(4) A healthcare facility shall manage its non-pharmaceutical hazardous waste in accordance with all applicable requirements of COMAR 26.13.01—26.13.10 based on whether the facility is a fully regulated generator or a Maryland-defined small quantity generator, as defined in COMAR 26.13.01.03B, taking into account the total amount of hazardous waste generated and accumulated, including both pharmaceutical hazardous waste and non-pharmaceutical hazardous waste.

F. Summary Table — Applicability to Healthcare Facilities.

(1) Table 1 of §F(3) of this regulation:

(a) Summarizes, for most generators, the criteria on the amount of hazardous waste generated in a calendar month that determine whether a healthcare facility is subject to the requirements specified in §E(3) of this regulation; and

(b) Identifies the federal hazardous waste generator category that applies to the facility.

(2) If a healthcare facility also generates any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill, into or on any land or water, of any acute hazardous waste listed in COMAR 26.13.02.16 or COMAR 26.13.02.19E, the facility shall also consider that waste in determining the facility’s federal generator category for the purposes of §E(1) of this regulation, based on the criteria in COMAR 26.13.03.01-1B.

(3) Table 1.

*Defining Characteristics of Generator, Unless §F(2) of This Regulation Applies*			Subject to Requirements in §E(3) of this Regulation?	Federal Hazardous Waste Generator Category of Healthcare Facility
Amount of Hazardous Waste Pharmaceuticals Generated, Calendar Month	Amount of Non-Pharmaceutical Hazardous Waste Generated, Calendar Month	Total Hazardous Waste Generated, Calendar Month (Hazardous Waste Pharmaceuticals and Non-Pharmaceutical Haz. Waste)	Subject to Requirements in §E(3) of this Regulation?
Any amount, acute or non-acute	> 1 kg acute, ≥ 1000 kg non-acute, or both	>1 kg acute, ≥ 1000 kg non-acute, or both	Yes. See §E(1)(a) of this regulation.	large quantity generator
Any amount, acute or non-acute	acute ≤ 1 kg; and non-acute > 100 kg and < 1000 kg	acute ≤ 1 kg; and non-acute > 100 kg and < 1000 kg	Yes. See §E(1)(a) of this regulation.	small quantity generator
Any amount, acute or non-acute	acute ≤ 1 kg; and non-acute > 100 kg and < 1000 kg	> 1 kg acute, ≥ 1000 kg non-acute, or both	Yes. See §E(1)(a) of this regulation	small quantity generator
> 1 kg acute, > 100 kg non-acute, or both	≤ 1 kg acute and ≤ 100 kg non-acute	> 1 kg acute, > 100 kg non-acute, or both	Yes. See §E(1)(b) of this regulation.	very small quantity generator
≤ 1 kg acute and ≤ 100 kg non-acute	≤ 1 kg acute and ≤ 100 kg non-acute	> 1 kg acute, > 100 kg non-acute, or both	Yes. See §E(1)(c) of this regulation.	very small quantity generator
≤ 1 kg acute and ≤ 100 kg non-acute	≤ 1 kg acute and ≤ 100 kg non-acute	≤ 1 kg acute and ≤ 100 kg non-acute	No, unless the facility voluntarily elects to manage hazardous waste pharmaceuticals in accordance with these provisions. See §D(1) of this regulation for applicable requirements.	very small quantity generator
Long-term Care Facility with ≤ 20 Beds			No, unless the Department demonstrates that the facility does not qualify to be a Very Small Quantity Generator. See §D(2) of this regulation for applicable requirements.	Presumed to be a very small quantity generator unless the Department demonstrates otherwise

Agency Note: In Table 1 of §F(3) of this regulation, “<” means less than; “≤” means less than or equal, “>” means greater than, and “≥” means greater than or equal.

G. Applicability — Reverse Distributors. A reverse distributor:

(1) Is subject to Regulations .33—.35 and .47—.49 of this chapter instead of COMAR 26.13.03—26.13.06 with respect to the management of hazardous waste pharmaceuticals; and

(2) Shall manage its non-pharmaceutical hazardous waste in accordance with all applicable requirements of COMAR 26.13.01—26.13.10.

H. Applicability — Other Entities. An entity other than a healthcare facility or a reverse distributor that generates or manages a hazardous waste pharmaceutical, such as a pharmaceutical manufacturer or a reverse logistics center:

(1) Is not subject to Regulations .33—.49 of this chapter; and

(2) Shall manage the hazardous waste pharmaceutical in accordance with the applicable requirements of COMAR 26.13.03.

.33 Prohibition on Sewer Disposal of Hazardous Waste Pharmaceuticals.

A. This regulation applies to:

(1) A healthcare facility that meets any of the following criteria:

(a) The facility is managing hazardous waste pharmaceuticals under the provisions of COMAR 26.13.02.05, as provided in Regulation .32D(1)(c)(i) of this chapter;

(b) The facility is voluntarily complying with the requirements of Regulations .37—.48 of this chapter, in accordance with Regulation .37A(2) of this chapter; or

(c) The facility is subject to Regulations .37—.48 of this chapter; and

(2) A reverse distributor.

B. A facility identified in §A of this regulation may not discharge a hazardous waste pharmaceutical to a sewer system that passes through to a publicly owned treatment works (POTW).

C. Healthcare facilities and reverse distributors remain subject to the prohibitions in 40 CFR §403.5(b), which prohibits introduction of specified pollutants into a POTW.

.34 Conditional Exemption — Controlled Substances and Household Waste Pharmaceuticals.

A. If the conditions of §B of this regulation are met, the following are exempt from the requirements of COMAR 26.13.03—26.13.10:

(1) A hazardous waste pharmaceutical that is also listed on a schedule of controlled substances by the Drug Enforcement Administration in 21 CFR Part 1308; and

(2) A household waste pharmaceutical that is collected in a take-back event or program, including, but not limited to, a household waste pharmaceutical that is:

(a) Collected by an authorized collector, as defined by the Drug Enforcement Administration, who is registered with the Drug Enforcement Administration; and

(b) Commingled by the authorized collector with controlled substances from an ultimate user as defined by the Drug Enforcement Administration.

B. Conditions for Exemption. The exemption of §A of this regulation applies if a waste pharmaceutical identified in §A of this regulation is:

(1) Managed in compliance with the sewer prohibition of Regulation .33 of this chapter;

(2) Collected, stored, transported, and disposed of in compliance with all applicable Drug Enforcement Administration regulations for controlled substances; and

(3) Either:

(a) Destroyed by a method that the Drug Enforcement Administration has publicly deemed in writing to meet the Drug Enforcement Administration’s non-retrievable standard of destruction; or

(b) Combusted at one of the facilities identified in 40 CFR §266.506(b)(3)(i)—(v).

.35 Residues of Hazardous Waste Pharmaceuticals in Empty Containers.

A. This regulation establishes criteria under which a container that held a pharmaceutical is considered to be empty.

B. A container that is empty according to the criteria in this regulation is not regulated as hazardous waste unless the materials of construction of the container itself cause the container to meet the definition of hazardous waste.

C. Stock, Dispensing and Unit-dose Containers.

(1) Except as provided in §C(2) of this regulation, the following containers are considered empty, and any residues remaining in the containers are not regulated as hazardous waste if the pharmaceuticals have been removed from the container using the practices commonly employed to remove materials from that type of container:

(a) A stock bottle, dispensing bottle, vial, or ampule; and

(b) A unit-dose container, such as a unit-dose packet, cup, wrapper, blister pack, or delivery device.

(2) The criterion of §C(1) of this regulation does not apply to a stock bottle, dispensing bottle, vial, or ampule that exceeds 1 liter or has a capacity of more than 10,000 pills.

D. Syringes.

(1) A syringe is considered empty and the residues are not regulated as hazardous waste if the contents of the syringe have been removed by fully depressing the plunger of the syringe.

(2) At a healthcare facility that is operating under Regulations .32—.47 of this chapter, if a syringe is not empty, the generator of the waste shall place the syringe with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of:

(a) As a noncreditable hazardous waste pharmaceutical under Regulations .33—.47 of this chapter; and

(b) Any applicable federal, state, and local requirements for sharps containers and medical waste.

E. Intravenous (IV) Bags.

(1) An IV bag is considered empty and the residues are not regulated as hazardous waste if:

(a) The pharmaceuticals in the IV bag have been fully administered to a patient; or

(b) The IV bag:

(i) Held non-acute hazardous waste pharmaceuticals; and

(ii) Is empty as defined in COMAR 26.13.02.07B(1).

(2) At a healthcare facility that is operating under Regulations .32—.47 of this chapter, if an IV bag that is going to be discarded is not empty as specified in §E(1) of this regulation, the generator shall place the IV bag with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of as a noncreditable hazardous waste pharmaceutical under Regulations .33 — .47 of this chapter.

F. Other Containers, Including Delivery Devices.

(1) This section applies to any type of container, including a delivery device, that:

(a) Is not identified in §§C—E of this regulation;

(b) Held or contains a pharmaceutical that would be regulated as hazardous waste if discarded; and

(c) Is unused, partially administered or fully administered.

(2) Examples of containers subject to this section include inhalers, aerosol cans, nebulizers, and tubes of ointments, gels, or creams.

(3) Except as specified in §F(4) of this regulation, at a healthcare facility that is operating under Regulations .32—.47 of this chapter, the generator of a container identified in §F(1) of this regulation that is going to be discarded shall manage the container as a non-creditable hazardous waste pharmaceutical under Regulations .33—.47 of this chapter.

(4) §F(3) of this regulation does not apply if the container that is going to be discarded:

(a) Held non-acute hazardous waste pharmaceuticals; and

(b) Is empty as defined in COMAR 26.13.02.07B(1) or B(2).

.36 Optional Provisions — Healthcare Facilities that Qualify as Very Small Quantity Generators.

A. Applicability.

(1) This regulation applies to a healthcare facility that:

(a) Is a very small quantity generator under federal regulations, as described in COMAR 26.13.03.01-1B, when counting all of the hazardous waste it generates in a calendar month, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste; and

(b) Has not voluntarily elected to manage hazardous waste pharmaceuticals in accordance with the requirements of Regulations .37—.48 of this chapter, as provided in Regulation .37A(2) of this chapter.

(2) The provisions of §B—D of this regulation may be used by a healthcare facility that meets the criteria of §A(1)(b) of this regulation.

B. A healthcare facility identified in §A of this regulation may send the healthcare facility’s potentially creditable pharmaceuticals to a reverse distributor.

C. Off-site Consolidation of Hazardous Waste Pharmaceuticals. A healthcare facility identified in §A of this regulation may send a hazardous waste pharmaceutical it generates to an off-site location of another generator if:

(1) The receiving site is a healthcare facility that is:

(a) Located in Maryland and meets the conditions in:

(i) Regulation .45 of this chapter, if a noncreditable hazardous waste pharmaceutical is being shipped; and

(ii) Regulation .46B of this chapter, if a potentially creditable hazardous waste pharmaceutical is being shipped; or

(b) Not located in Maryland and meets requirements that correspond to the requirements of §C(1)(a) of this regulation that are applicable in the state in which the receiving facility is located; or

(2) The healthcare facility proposes to send the hazardous waste pharmaceutical off-site to a hazardous waste generator, and:

(a) The healthcare facility meets the conditions in COMAR 26.13.02.05D(2)(h); and

(b) The receiving hazardous waste generator meets the conditions in:

(i) COMAR 26.13.03.03-11 if the generator is located in Maryland; or

(ii) 40 CFR §262.17(f) or the corresponding requirements of the state in which the off-site generator is located if the generator is not located in Maryland.

D. Long-term Care Facilities.

(1) Except as provided in §D(2) of this regulation, a long-term care facility that meets the conditions in §A of this regulation may dispose of a hazardous waste pharmaceutical in an on-site collection receptacle of an authorized collector, as defined by the Drug Enforcement Administration, that is registered with the Drug Enforcement Administration if the contents of the receptacle are collected, stored, transported, destroyed, and disposed of in compliance with all Drug Enforcement Administration regulations for controlled substances.

(2) §D(1) of this regulation does not apply to contaminated personal protective equipment or clean-up materials.

.37 Standards for Healthcare Facilities Managing Hazardous Waste Pharmaceuticals — Applicability.

A. This regulation and Regulations .38—.48 of this chapter apply to a healthcare facility that:

(1) Meets the criteria specified in Regulation .32E(1) of this chapter or is identified in Regulation .32E(2) of this chapter as being subject to these requirements; or

(2) Is identified in Regulation .32D(1) of this chapter and has voluntarily elected to comply with this regulation and Regulations .38—.48 of this chapter, as provided in Regulation .32D(1)(b) of this chapter.

B. A healthcare facility identified in §A of this regulation shall:

(1) Manage the following in accordance with the provisions of Regulations .38—.45, and .47 of this chapter:

(a) Non-creditable hazardous waste pharmaceuticals; and

(b) Potentially creditable hazardous waste pharmaceuticals that are not destined for a reverse distributor; and

(2) Manage potentially creditable hazardous waste pharmaceuticals that are destined for a reverse distributor in accordance with the provisions of Regulations .38, .46 and .48 of this chapter.

.38 Notification — Healthcare Facilities Managing Hazardous Waste Pharmaceuticals.

A. This regulation establishes requirements for a facility identified in Regulation .37A of this chapter to notify the Department that the facility:

(1) Is operating under the standards of this chapter relating to the management of hazardous waste pharmaceuticals; and

(2) Will no longer be operating under the standards of this chapter relating to the management of hazardous waste pharmaceuticals.

B. Notification of Operation.

(1) A healthcare facility shall notify the Department that the healthcare facility is operating under the standards of this chapter relating to the management of hazardous waste pharmaceuticals by:

(a) Submitting an initial or revised Site Identification Form (EPA Form 8700-12) to the Department; and

(b) Completing the questions on “Pharmaceutical Activities” in the “Additional Regulated Waste Activities” section of the Site Identification Form, checking the “yes” box on the form to indicate that the facility is operating under 40 CFR Part 266, Subpart P for the management of hazardous waste pharmaceuticals.

(2) A healthcare facility submitting a notification under this section is not required to list waste codes for the facility’s hazardous waste pharmaceuticals in Box 10B of the Site Identification Form, but shall list waste codes in Box 10B for non-pharmaceutical hazardous wastes that are generated or managed at the facility.

(3) A person that is the owner or operator of multiple sites or locations that are operating under the standards of this chapter relating to the management of hazardous waste pharmaceuticals shall submit a separate notification for each site or existing EPA identification number, except that a single notification is required for a location with multiple sites that are considered to be on the site of a single facility.

(4) Deadlines for the Notification Required by §B(1) of this Regulation.

(a) A healthcare facility that already has an EPA identification number shall make the notification:

(i) As part of the healthcare facility’s next biennial report of hazardous waste activity, if the healthcare facility’s generator status under federal regulations is “large quantity generator”, or if federal regulations otherwise require the healthcare facility to submit a biennial report of hazardous waste activity; or

(ii) If the healthcare facility does not meet the criteria of §B(4)(a)(i) of this regulation, within 60 days after the effective date of §B of this regulation, or within 60 days after the date the healthcare facility becomes subject to the standards of this chapter relating to the management of hazardous waste pharmaceuticals, whichever is later.

(b) A healthcare facility that does not have an EPA identification number shall make the notification within 60 days after the effective date of §B of this regulation, or within 60 days after the date the healthcare facility becomes subject to the standards of this chapter relating to the management of hazardous waste pharmaceuticals, whichever is later.

(5) A healthcare facility shall keep a copy of its notification on file for as long as the healthcare facility is operating under the standards of this chapter relating to the management of hazardous waste pharmaceuticals.

C. Notification of Withdrawal.

(1) Applicability. This section applies to a healthcare facility that:

(a) Either:

(i) Had been required to manage hazardous waste pharmaceuticals in accordance with the regulations identified in Regulation .32E(3) of this chapter, but is no longer required to do so because the facility is now classified as a very small quantity generator under federal regulations, as described in COMAR 26.13.03.01-1B, when counting all of the hazardous waste it generates in a calendar month, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste; and

(ii) Will not be voluntarily complying with the requirements of Regulation .32E(3) of this chapter for the management of the facility’s hazardous waste pharmaceuticals, as an alternative to managing the hazardous waste pharmaceuticals in accordance with COMAR 26.13.02.05 and the optional provisions of Regulation .36 of this chapter; or

(b) Had voluntarily elected to comply with the requirements of Regulation .32E(3) of this chapter for the management of the facility’s hazardous waste pharmaceuticals, but no longer will be doing so, and will instead be managing the hazardous waste pharmaceuticals in accordance with COMAR 26.13.02.05 and the optional provisions of Regulation .36 of this chapter.

(2) A healthcare facility identified in §C(1) of this regulation shall:

(a) Before beginning to manage hazardous waste pharmaceuticals in accordance with COMAR 26.13.02.05, notify the Department that the healthcare facility will no longer be operating under the standards of this chapter relating to the management of hazardous waste pharmaceuticals;

(b)Make the notification required by §C(2)a) of this regulation by:

(i) Submitting a Site Identification Form (EPA Form 8700-12) to the Department; and

(ii) Completing the questions on “Pharmaceutical Activities” in the “Additional Regulated Waste Activities” section of the Site Identification Form, as directed in the instructions for the form; and

(c) Keep a copy of its withdrawal notification on file for at least 3 years from the date of signature on the notification of withdrawal.

(3) A healthcare facility submitting a notification under this section is not required to list waste codes for the facility’s hazardous waste pharmaceuticals in Box 10B of the Site Identification Form.

(4) A person that is the owner or operator of multiple sites or locations that are required to submit notification under this section shall submit a separate notification of withdrawal for each affected site or existing EPA identification number, except that a single notification is required for a location with multiple sites that are considered to be on the site of a single facility.

.39 General Standards — Healthcare Facilities Managing Non-Creditable Hazardous Waste Pharmaceuticals.

A. Training. The owner or operator of a healthcare facility managing non-creditable hazardous waste pharmaceuticals shall ensure that all personnel that manage non-creditable hazardous waste pharmaceuticals are thoroughly familiar with proper waste handling and emergency procedures relevant to their responsibilities during normal facility operations and emergencies.

B. Hazardous Waste Determination.

(1) A healthcare facility that generates a solid waste that is a non-creditable pharmaceutical shall determine whether that pharmaceutical is a hazardous waste pharmaceutical by determining whether the waste is listed as a hazardous waste in COMAR 26.13.02.15—.19, and whether the waste exhibits any of the characteristics of hazardous waste defined in COMAR 26.13.02.10—.14.

(2) In determining whether a solid waste is a hazardous waste, a healthcare facility shall follow the procedures in COMAR 26.13.03.02-1.

(3) A healthcare facility shall use the hazardous waste determination conducted in accordance with this section to determine the applicability of Regulations .32—.48 of this chapter to the waste, except that the healthcare facility may choose to manage its non-hazardous waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals under Regulations .32—.48 of this chapter.

C. Land Disposal Restrictions. A healthcare facility:

(1) Shall ensure that the non-creditable hazardous waste pharmaceuticals generated by the facility are managed in accordance with the land disposal restrictions of 40 CFR Part 268, as incorporated by reference at COMAR 26.13.09.03A; and

(2.) Is not required, in complying with 40 CFR §268.7(a), to identify the hazardous waste numbers, also referred to as hazardous waste codes, on the land disposal restrictions notification.

D. Response to Spills. A healthcare facility shall:

(1) Immediately contain a spill of a non-creditable hazardous waste pharmaceutical; and

(2) Manage spill cleanup materials as non-creditable hazardous waste pharmaceuticals in accordance with Regulations .32—.48 of this chapter.

.40 Container Standards — Healthcare Facilities Managing Non-Creditable Hazardous Waste Pharmaceuticals.

A. A healthcare facility may not place a non-creditable hazardous waste pharmaceutical in a container unless the container:

(1) Is structurally sound;

(2) Is compatible with the contents of the container; and

(3) Lacks evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions.

B. A healthcare facility that manages ignitable or reactive non-creditable hazardous waste pharmaceuticals in a container, or that mixes or commingles incompatible non-creditable hazardous waste pharmaceuticals in a container shall manage the container so that the container does not have the potential to:

(1) Generate:

(a) Extreme heat or pressure;

(b) A fire or an explosion; or

(c) A violent reaction;

(2) Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health;

(3) Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosion;

(4) Damage the structural integrity of the container; or

(5) Threaten human health or the environment through means other than those identified in §B(1)—(4) of this regulation.

C. A healthcare facility shall keep each container of non-creditable hazardous waste pharmaceuticals closed and secured in a manner that prevents unauthorized access to the contents of the container.

D. Commingling Non-creditable Hazardous Waste Pharmaceuticals with Non-hazardous Non-creditable Waste Pharmaceuticals.

(1) Except as provided in §D(2) of this regulation, a healthcare facility may accumulate non-creditable hazardous waste pharmaceuticals and non-hazardous non-creditable waste pharmaceuticals in the same container.

(2) A healthcare facility may not accumulate the following non-creditable hazardous waste pharmaceuticals in the same container with non-hazardous non-creditable waste pharmaceuticals:

(a) Non-creditable hazardous waste pharmaceuticals that are prohibited from being combusted because of the dilution prohibition of 40 CFR §268.3(c), namely, metal bearing waste codes listed in Appendix XI of 40 CFR Part 268 that meet none of the criteria in 40 CFR §268.3(c)(1)—(6); and

(b) Non-creditable hazardous waste pharmaceuticals that are prohibited from being lab packed by 40 CFR §268.42(c), namely, wastes having waste codes listed in Appendix IV of 40 CFR Part 268.

(3) A healthcare facility shall label a container that contains a non-creditable hazardous waste pharmaceutical identified in §D(2) of this regulation with all applicable EPA hazardous waste numbers, which are also referred to as hazardous waste codes.

E. Container Labeling. A healthcare facility shall label or clearly mark each container of non-creditable hazardous waste pharmaceuticals with the phrase “Hazardous Waste Pharmaceuticals”.

.41 Accumulation Time Limit — Non-Creditable Hazardous Waste Pharmaceuticals.

A. A healthcare facility may accumulate a non-creditable hazardous waste pharmaceutical on site for 1 year or less without having to either:

(1) Obtain a CHS permit issued under COMAR 26.13.07 that authorizes storage of the pharmaceutical; or

(2) Qualify for interim status, as defined in COMAR 26.13.01.03B, with respect to the waste management unit in which the pharmaceutical is being managed.

B. A healthcare facility that accumulates a non-creditable hazardous waste pharmaceutical on site shall demonstrate the length of time that the non-creditable hazardous waste pharmaceutical has been accumulating, starting from the date that the pharmaceutical first became a waste, as specified in §C of this regulation.

C. A healthcare facility shall demonstrate the length of time that a non-creditable hazardous waste pharmaceutical has been accumulating by one or more of the following methods:

(1) Marking or labeling the container of the non-creditable hazardous waste pharmaceutical with the date that the non-creditable hazardous waste pharmaceutical became a waste;

(2) Maintaining an inventory system that identifies the date that the non-creditable hazardous waste pharmaceutical item being accumulated became a waste; or

(3) Placing the non-creditable hazardous waste pharmaceutical in a specific area in which non-creditable hazardous waste pharmaceuticals are accumulated, identifying the earliest date that any of the non-creditable hazardous waste pharmaceuticals in the area became a waste, and having that information readily available during a compliance inspection, by, for example, marking or labeling the accumulation area with the accumulation start-date, or by entering the current earliest accumulation start-date in a log book or facility operating record.

.42 Management of Rejected Shipments of Non-Creditable Hazardous Waste Pharmaceuticals by Healthcare Facilities.

A. Applicability. This regulation applies to a healthcare facility that sends a shipment of non-creditable hazardous waste pharmaceuticals to a designated facility with the understanding that the designated facility can accept and manage the waste, and later receives that shipment back as a rejected load in accordance with the manifest discrepancy provisions of:

(1) COMAR 26.13.05.05C or COMAR 26.13.06.05, as applicable, if the designated facility is located in Maryland; or

(2) 40 CFR §264.72 or 40 CFR §265.72, as applicable, or equivalent state requirements, if the designated facility is not located in Maryland.

B. A healthcare facility identified in §A of this regulation may accumulate a rejected non-creditable hazardous waste pharmaceutical on site for up to an additional 90 days if the healthcare facility manages the rejected shipment in accordance with Regulation .40 of this chapter.

C. Upon receipt of a rejected shipment of a non-creditable hazardous waste pharmaceutical, a healthcare facility shall:

(1) Sign either:

(a) Item 18c of the original manifest, if the original manifest was used for the returned shipment; or

(b) Item 20 of the new manifest, if a new manifest was used for the returned shipment;

(2) Provide the transporter with a copy of the manifest;

(3) Within 30 days of receipt of the rejected shipment, send a copy of the manifest to the designated facility that returned the shipment to the healthcare facility; and

(4) Within 90 days of receipt of the rejected shipment, transport or offer for transport the returned shipment in accordance with the shipping standards of Regulation .47A—E of this chapter.

.43 Reporting by Healthcare Facilities for Non-Creditable Hazardous Waste Pharmaceuticals.

A. Biennial Reporting. Healthcare facilities are not subject to biennial reporting requirements under COMAR 26.13.03.06B with respect to non-creditable hazardous waste pharmaceuticals managed under Regulations .32—.49 of this chapter.

B. Exception Reporting for a Missing Copy of the Manifest.

(1) For a shipment of a non-creditable hazardous waste pharmaceutical from a healthcare facility to a designated facility, if the healthcare facility does not receive a copy of the manifest with the signature of the owner or operator of the designated facility within 60 days of the date that the initial transporter accepted the non-creditable hazardous waste pharmaceutical, the healthcare facility shall submit the following to the unit in the Department responsible for oversight of the State’s hazardous waste management program:

(a) A legible copy of the original manifest for which the healthcare facility has not received confirmation of delivery to the designated facility; and

(b) A handwritten or typed note on the copy of the manifest itself, or on an attached sheet of paper, that:

(i) States that the return copy of the manifest was not received;

(ii) Explains the efforts taken to locate the non-creditable hazardous waste pharmaceuticals; and

(iii) Presents the results of the efforts taken to locate the non-creditable hazardous waste pharmaceuticals.

(2) For a shipment of a non-creditable hazardous waste pharmaceutical from a healthcare facility that was rejected by the designated facility and shipped to an alternate facility using appropriate manifest procedures, if the healthcare facility has not received, within 60 days of the date the rejected shipment was accepted by the initial transporter forwarding the shipment from the originally designated facility to the alternate facility, a copy of the manifest with the signature of the owner or operator of the alternate facility, the healthcare facility shall submit the following to the unit in the Department responsible for oversight of the State’s hazardous waste management program:

(a) A legible copy of the original manifest for which the healthcare facility has not received confirmation of delivery to the designated facility; and

(b) A handwritten or typed note on the copy of the manifest itself, or on an attached sheet of paper, that:

(i) States that the return copy of the manifest was not received;

(ii) Explains the efforts taken to locate the non-creditable hazardous waste pharmaceuticals; and

(iii) Presents the results of the efforts taken to locate the non-creditable hazardous waste pharmaceuticals.

C. Additional Reports. The Department may require healthcare facilities to furnish additional reports concerning the quantities and disposition of non-creditable hazardous waste pharmaceuticals.

.44 Record Keeping by Healthcare Facilities for Non-Creditable Hazardous Waste Pharmaceuticals.

A. Manifests and Exception Reports. Unless a specified period of retention is extended in accordance with §C of this regulation, a healthcare facility shall:

(1) Keep a copy of each manifest signed in accordance with COMAR 26.13.03.04E(1) for 3 years or until the healthcare facility receives a signed copy of the manifest from the designated facility that received the non-creditable hazardous waste pharmaceuticals that are being tracked by the manifest;

(2) Retain as a record each signed copy of a manifest received from the designated facility identified on the manifest, with the period of retention being at least 3 years from the date the waste was accepted by the initial transporter; and

(3) Keep a copy of each exception report required by Regulation .43B of this chapter for a period of at least 3 years from the date of the report;

B. Waste Determinations.

(1) Unless a healthcare facility is excluded from this requirement by §B(3) of this regulation, a healthcare facility shall keep records of any test result, waste analysis, or other determination made to support the healthcare facility’s hazardous waste determinations consistent with COMAR 26.13.03.02-2, the record keeping requirements for hazardous waste determinations by generators of hazardous waste.

(2) Unless the period of retention is extended in accordance with §C of this regulation, a healthcare facility shall retain the records identified in §B(1) of this regulation for at least 3 years from the date that the waste that was the subject of the waste determination was last sent to on-site or off-site treatment, storage, or disposal.

(3) A healthcare facility that manages all of the healthcare facility’s non-creditable non-hazardous waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals is not required to keep documentation of hazardous waste determinations for waste pharmaceuticals.

C. The periods of retention for records referred to in §A—B of this regulation are extended:

(1) Automatically during the course of any unresolved enforcement action regarding the regulated activity; or

(2) As requested by the Department or the Regional Administrator of Region 3 of the EPA.

D. The healthcare facility shall ensure that any record required to be kept by this regulation is made readily available upon the request of an inspector representing the Department or the EPA.

.45 Acceptance of Non-Creditable Hazardous Waste Pharmaceuticals from Off Site.

A. This regulation establishes conditions under which a healthcare facility may accept non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility that qualifies, under federal regulations, as a very small quantity generator (VSQG) of hazardous waste.

B. Regulation .32F of this chapter specifies criteria that determine whether a generator of hazardous waste pharmaceuticals qualifies as a very small quantity generator of hazardous waste under federal regulations.

C. A healthcare facility that does not have a permit or interim status that allows the facility to accept hazardous waste from off site may accept non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility if:

(1) The off-site facility qualifies, under federal regulations, as a very small quantity generator (VSQG) of hazardous waste;

(2) Either:

(a) The receiving facility and the VSQG healthcare facility that is sending the non-creditable hazardous waste pharmaceuticals off site are under the control of the same person, as specified in §D of this regulation; or

(b) The receiving facility has a contractual or other documented business relationship by which the receiving healthcare facility supplies pharmaceuticals to the VSQG healthcare facility; and

(3) The receiving facility:

(a) Is operating under the provisions of Regulations .32—.48 of this chapter for the management of the receiving facility’s non-creditable hazardous waste pharmaceuticals;

(b) Manages the non-creditable hazardous waste pharmaceuticals that it receives from off site in compliance with the requirements of Regulations .32—.48 of this chapter; and

(c) Keeps records of the non-creditable hazardous waste pharmaceuticals that the facility receives from off site for 3 years from the date that the shipment is received, except that the periods of retention of these records is extended automatically during the course of any unresolved enforcement action regarding the regulated activity.

D. For the purposes of this regulation:

(1) “Person” has the meaning given by the definition in COMAR 26.13.01.03B; and

(2) “Control”:

(a) Means the power to direct the policies of the healthcare facility, whether by the ownership of stock, voting rights, or otherwise; and

(b) Does not include the situation when a contractor operates healthcare facilities on behalf of a different person.

.46 Standards for Healthcare Facilities Managing Potentially Creditable Hazardous Waste Pharmaceuticals.

A. Hazardous Waste Determination for Potentially Creditable Pharmaceuticals.

(1) A healthcare facility that generates a solid waste that is a potentially creditable pharmaceutical shall determine whether that pharmaceutical is a hazardous waste pharmaceutical by determining whether the waste is listed as a hazardous waste in COMAR 26.13.02.15—.19, and whether the waste exhibits any of the characteristics of hazardous waste defined in COMAR 26.13.02.10—.14.

(2) In determining whether a solid waste is a hazardous waste, a healthcare facility shall follow the procedures in COMAR 26.13.03.02-1.

(3) A healthcare facility shall use the hazardous waste determination conducted in accordance with this section to determine the applicability of Regulations .32—.49 of this chapter to the waste, except that the healthcare facility may choose to manage its potentially creditable non-hazardous waste pharmaceuticals as potentially creditable hazardous waste pharmaceuticals under Regulations .32—.49 of this chapter.

B. Acceptance of Potentially Creditable Hazardous Waste Pharmaceuticals from Off Site.

(1) This section establishes conditions under which a healthcare facility may accept potentially creditable hazardous waste pharmaceuticals from an off-site healthcare facility that qualifies, under federal regulations, as a very small quantity generator (VSQG) of hazardous waste.

(2) Regulation .32F of this chapter specifies criteria that determine whether a generator of hazardous waste pharmaceuticals qualifies as a very small quantity generator of hazardous waste under federal regulations.

(3). For the purposes of this regulation:

(a) “Person” has the meaning given by the definition in COMAR 26.13.01.03B; and

(b) “Control”:

(i) Means the power to direct the policies of the healthcare facility, whether by the ownership of stock, voting rights, or otherwise; and

(ii) Does not include the situation when a contractor operates healthcare facilities on behalf of a different person.

(4) A healthcare facility that does not have a permit or interim status that allows the facility to accept hazardous waste from off site may accept potentially creditable hazardous waste pharmaceuticals from an off-site healthcare facility if:

(a) The off-site facility qualifies, under federal regulations, as a very small quantity generator (VSQG) of hazardous waste;

(b) Either:

(i) The receiving facility and the VSQG healthcare facility that is sending the potentially creditable hazardous waste pharmaceuticals off site are under the control of the same person, as specified in §B(3) of this regulation; or

(ii) The receiving facility has a contractual or other documented business relationship whereby the receiving healthcare facility supplies pharmaceuticals to the VSQG healthcare facility; and

(c) The receiving facility:

(i) Is operating under the provisions of Regulations .32—.49 of this chapter for the management of the receiving facility’s potentially creditable hazardous waste pharmaceuticals;

(ii) Manages the potentially creditable hazardous waste pharmaceuticals that it receives from off site in compliance with the requirements of Regulations .32—.49 of this chapter; and

(iii) Keeps records of the potentially creditable hazardous waste pharmaceuticals that the facility receives from off site for 3 years from the date that the shipment is received, except that the periods of retention of these records is extended automatically during the course of any unresolved enforcement action regarding the regulated activity;

C. Prohibition of Shipment. Except for potentially creditable hazardous waste pharmaceuticals, a healthcare facility may not send hazardous waste to a reverse distributor.

D. Biennial Reporting. A healthcare facility is not subject to biennial reporting requirements under COMAR 26.13.03.06B with respect to potentially creditable hazardous waste pharmaceuticals managed under Regulations .32—.49 of this chapter.

E. Record Keeping. A healthcare facility that initiates a shipment of a potentially creditable hazardous waste pharmaceutical to a reverse distributor shall:

(1) Keep the following records, in either a paper or electronic format, for each shipment of a potentially creditable hazardous waste pharmaceutical:

(a) The confirmation of delivery; and

(b) The shipping paper or papers prepared in accordance with 49 CFR Part 172 Subpart C, if applicable;

(2) Unless the period of retention is extended in accordance with §E(3) of this regulation, retain the records identified in §E(1) of this regulation for at least 3 years from the date of shipment;

(3) Maintain a record beyond the period specified in §E(2) of this regulation:

(a) During the course of any unresolved enforcement action regarding the regulated activity; or

(b) As requested by the Department or the Regional Administrator of Region 3 of the EPA; and

(4) Ensure that any record required to be kept by this regulation is made readily available upon the request of an inspector representing the Department or the EPA.

F. Response to Spills. A healthcare facility shall:

(1) Immediately contain a spill of a potentially creditable hazardous waste pharmaceutical; and

(2) Manage clean-up materials from a spill of a potentially creditable hazardous waste pharmaceutical as non-creditable hazardous waste pharmaceuticals in accordance with Regulations .32—.48 of this chapter.

.47 Shipping Requirements — Non-creditable Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals.

A. This regulation establishes requirements that apply to:

(1) A healthcare facility shipping non-creditable hazardous waste pharmaceuticals off site; and

(2) A reverse distributor shipping evaluated hazardous wastes pharmaceuticals off site.

B. A person identified in §A of this regulation shall:

(1) Ship the waste identified in §A of this regulation to a designated facility that is authorized to accept the specified hazardous waste by a hazardous waste facility permit, interim status authority, or other legal mechanism consistent with state and federal hazardous waste regulations; and

(2) Ensure that the waste is transported by a transporter that has been issued a CHS Hauler Certificate in accordance with COMAR 26.13.04.01C.

C. Pre-transport Requirements — Healthcare Facilities. A healthcare facility shall comply with the following requirements before transporting off site or offering for transport off site a non-creditable hazardous waste pharmaceutical:

(1) Package the waste in accordance with the applicable U.S. Department of Transportation regulations on hazardous materials under 49 CFR Parts 173, 178, and 180;

(2) Label each package in accordance with the applicable U.S. Department of Transportation regulations on hazardous materials under 49 CFR Part 172 Subpart E;

(3) Mark each package of hazardous waste pharmaceuticals in accordance with the applicable U.S. Department of Transportation regulations on hazardous materials under 49 CFR Part 172 Subpart D;

(4) Mark each container of 119 gallons or less being used in the off-site shipment with the following words and information in accordance with the requirements of 49 CFR § 172.304:

"HAZARDOUS WASTE — Federal Law Prohibits Improper Disposal. If found, contact the nearest police or public safety authority or the U. S. Environmental Protection Agency.

Healthcare Facility’s or Reverse Distributor’s Name and Address ____________________________.

Healthcare Facility’s or Reverse Distributor’s EPA Identification Number______________________

Manifest Tracking Number ___________________________________________________________ "

(5) Mark each lab pack container that will be incinerated in compliance with 40 CFR § 268.42(c) as follows:

(a) Mark the container with EPA Hazardous Waste Numbers D004, D005, D006, D007, D008, D010, and D011, when applicable, by either:

(i) Directly marking the applicable EPA Hazardous Waste Numbers on the container; or

(ii) Using an electronic system for data capture, storage, and retrieval, such as bar coding or a radio frequency identification tag, if the electronic system allows the destination facility to be informed of the container's contents for the purposes of compliance with applicable hazardous waste management regulations; and

(b) It is not necessary to mark the container with EPA Hazardous Waste Numbers other than those identified in §C(5)(a) of this regulation;

(6) Placard the shipment or offer the initial transporter the appropriate placards according to U.S. Department of Transportation regulations for hazardous materials under 49 CFR Part 172, Subpart F.

D. Pre-transport Requirements — Reverse Distributors. A reverse distributor shipping evaluated hazardous waste pharmaceuticals off site shall:

(1) Comply with the requirements of §C of this regulation; and

(2) Mark each container of 119 gallons or less that is being used in the off-site shipment with the EPA hazardous waste numbers of the wastes in the container by either:

(a) Directly marking the applicable EPA Hazardous Waste Numbers on the container; or

(b) Using a method described in §C(5)(a)(ii) of this regulation.

E. Manifesting.

(1) Except as specified in §E(2) of this regulation, a person identified in §A of this regulation shall comply with the manifest requirements of COMAR 26.13.03.04.

(2) A healthcare facility shipping non-creditable hazardous waste pharmaceuticals:

(a) Is not required to list all applicable hazardous waste numbers, also known as hazardous waste codes, in the “Waste Codes” section of the manifest form, item 13 of EPA Form 8700-22; and

(b) Shall write either the code “PHRM” or the code “PHARMS” in the “Waste Codes” section of the manifest form, item 13 of EPA Form 8700-22.

F. Export and Import Requirements.

(1) A healthcare facility or reverse distributor that exports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to COMAR 26.13.02.07.

(2) Import Requirements.

(a) A person that imports a non-creditable hazardous waste pharmaceutical or an evaluated hazardous waste pharmaceutical is subject to COMAR 26.13.02.07.

(b) A healthcare facility or a reverse distributor may not accept an imported non-creditable hazardous waste pharmaceutical or an imported evaluated hazardous waste pharmaceutical unless the healthcare facility or reverse distributor has a permit or interim status that allows hazardous waste to be accepted from off site.

.48 Shipments of Potentially Creditable Hazardous Waste Pharmaceuticals to a Reverse Distributor.

A. A healthcare facility or a reverse distributor that transports off site or offers for transport off site potentially creditable hazardous waste pharmaceuticals to a reverse distributor shall comply with all applicable U.S. Department of Transportation regulations in 49 CFR Parts 171—180 for any potentially creditable hazardous waste pharmaceutical that meets the definition of hazardous material in 49 CFR § 171.8.

Agency Note: For the purposes of the U.S. Department of Transportation’s regulations, a material is considered a hazardous waste if it is subject to the hazardous waste manifest requirements of the U.S. Environmental Protection Agency specified in 40 CFR Part 262. Because a potentially creditable hazardous waste pharmaceutical does not require a hazardous waste manifest, it is not considered a hazardous waste under the U.S. Department of Transportation’s regulations.

B. Delivery Confirmation. A reverse distributor that receives a shipment of potentially creditable hazardous waste pharmaceuticals:

(1) Shall, upon receipt of the shipment, provide confirmation of receipt to the healthcare facility or reverse distributor that initiated the shipment;

(2) Shall indicate in the confirmation of receipt that the shipment of potentially creditable hazardous waste pharmaceuticals has arrived at its destination and is under the control of the reverse distributor; and

(3) May provide the confirmation of receipt in a paper format or an electronic format.

C. Required Actions if a Timely Confirmation of Delivery is not Received. If 35 days have elapsed since a healthcare facility or reverse distributor initiated a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor, and the initiating shipper has not received confirmation of delivery, the initiating shipper shall promptly contact the carrier and the reverse distributor that was the intended recipient of the shipment to:

(1) Report that the delivery confirmation has not been received; and

(2) Determine the status of the potentially creditable hazardous waste pharmaceuticals that were shipped.

D. Exports. A healthcare facility or reverse distributor that sends a potentially creditable hazardous waste pharmaceutical to a foreign destination:

(1) Is not required to comply with the manifesting requirements of 40 CFR § 262.83(c);

(2) Shall comply with:

(a) The applicable sections of 40 CFR Part 262, Subpart H, as qualified by COMAR 26.13.03.07B(2); and

(b) §§A—C of this regulation.

E. Imports.

(1) A person that imports potentially creditable hazardous waste pharmaceuticals into the United States is subject to §§A—C of this regulation instead of 40 CFR Part 262, Subpart H.

(2) Immediately after a potentially creditable hazardous waste pharmaceutical enters the United States, the potentially creditable hazardous waste pharmaceutical is subject to all applicable requirements of Regulations .32—.49 of this chapter.

F. Transporter Requirements. A person that transports potentially creditable hazardous waste pharmaceuticals to a reverse distributor:

(1) May do so without meeting the requirements of COMAR 26.13.04 that apply to persons who transport hazardous waste; and

(2) Shall comply with all applicable requirements of the U.S. Department of Transportation for the transport of hazardous materials.

.49 Standards for Reverse Distributors.

A. This regulation establishes requirements for reverse distributors for the management of:

(1) Potentially creditable hazardous waste pharmaceuticals; and

(2) Evaluated hazardous waste pharmaceuticals.

B. A reverse distributor may accept potentially creditable hazardous waste pharmaceuticals from off site and accumulate potentially creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals on site without a hazardous waste permit and without having interim status if the reverse distributor complies with the requirements of §§C—D of this regulation.

C. Management Standards.

(1) As qualified by §C(2) of this regulation, a reverse distributor shall manage potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals in accordance with the following:

(a) The management standards of 40 CFR §266.510(a);

(b) Additional standards for management of potentially creditable hazardous waste pharmaceuticals destined for another reverse distributor as specified in 40 CFR §266.510(b)(1)—(2) and (4); and

(c) Additional standards for management of evaluated hazardous waste pharmaceuticals as specified in 40 CFR §266.510(c)(1)—(4) and 40 CFR §266.510(c)(7)—(10).

(2) In complying with the provisions of 40 CFR §266.510 cited in §C(1) of this regulation, a reverse distributor shall:

(a) Substitute “Department” for “EPA Regional Administrator”; and

(b) Refer to the table in COMAR 26.13.01.05B(2) to identify references to provisions in COMAR that should be substituted for corresponding references to federal regulations that are made in 40 CFR §266.510.

D. Shipping Requirements. A reverse distributor shall:

(1) Ship potentially creditable hazardous waste pharmaceuticals destined for another reverse distributor in accordance with the requirements of Regulation .48 of this chapter;

(2) Ship evaluated hazardous waste pharmaceuticals in accordance with the requirements of Regulation .47 of this chapter; and

(3) Ensure that an evaluated hazardous waste pharmaceutical that is shipped off-site from a location within the State or to a facility within the State is transported by a hauler and vehicle that is in compliance with COMAR 26.13.04.01C.

E. Permit Requirements. A reverse distributor is an operator of a hazardous waste treatment, storage, or disposal facility and is subject to applicable requirements of COMAR 26.13.05, .06, and .07 if the reverse distributor:

(1) Does not meet the conditions of this Regulation;

(2) Accepts manifested hazardous waste from off-site; or

(3) Treats or disposes of hazardous waste pharmaceuticals on site.

26.13. 11 Special Medical Wastes

Authority: Environment Article, §§7-104, 7-201 et seq., 9-252, and 9-314, Annotated Code of Maryland

.01 Purpose and Scope.

A. This chapter identifies those solid wastes that are subject to regulation as special medical wastes under COMAR 26.13.12 and 26.13.13.

B. In this chapter:

[A.] (1)—[ C.] (3) (text unchanged)

[D.] (4) Special medical waste is hereby exempted from the requirements of Environment Article, §§7-205, 7-224, 7-226, 7-232, [7-249(a)(3), 7-253(3), with respect to the driver's certificate only,] and §7-253(4), Annotated Code of Maryland.

SERENA MCILWAIN
Secretary of the Environment

Title 31
MARYLAND INSURANCE ADMINISTRATION

Subtitle 10 HEALTH INSURANCE—GENERAL

31.10.51 Mental Health Benefits and Substance Use Disorder Benefits—Reports on Nonquantitative Treatment Limitations and Data

Authority: Insurance Article, §§2-109(a)(1) and 15-144, Annotated Code of Maryland

Notice of Proposed Action

[25-018-P]

The Acting Insurance Commissioner proposes to amend Regulations .03 and .04 repeal existing Regulation .05, amend and recodify existing Regulations .06 and .07 to be Regulation .05 and .06, and recodify existing Regulation .08 to be Regulation .07 under COMAR 31.10.51 Mental Health Benefits and Substance Use Disorder Benefits—Reports on Nonquantitative Treatment Limitations and Data Notices of Cancellation, Nonrenewal, Premium Increase, and Reduction in Coverage.

Statement of Purpose

The purpose of this action is to amend COMAR 31.10.51 Mental Health Benefits and Substance Use Disorder Benefits—Reports on Nonquantitative Treatment Limitations and Data to conform to recent changes to corresponding federal regulations under 45 C.F.R. §146.136, and to implement amendments made to Insurance Article, §15-144, Annotated Code of Maryland during the 2024 General Assembly legislative session. Chapter 234 (H.B. 1074) modified the nonquantitative treatment limitation reporting requirements, necessitating certain revisions to the uniform definitions and methodologies for the reporting requirements currently described in COMAR 31.10.51.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Jessica Blackmon, Administrative Law Clerk, Maryland Insurance Administration, 200 Saint Paul Place, Suite 2700, Baltimore, MD 21202, or call 4104682019, or email to insuranceregreview.mia@maryland.gov. Comments will be accepted through June 2, 2025. A public hearing has not been scheduled.

.03 Definitions.

A. (text unchanged)

B. Terms Defined.

(1) “Analysis report” means the report required by Insurance Article, [§15-144], §15-144(c)(2), Annotated Code of Maryland.

(2) (text unchanged)

[(3) “Data report” means the report required by Insurance Article, §15-144(f), Annotated Code of Maryland.]

[(4)] (3) “Evidentiary standards” [means the carrier’s defined level and type of evidence necessary to evaluate whether a given factor is established, present, or utilized, which results in the determination to apply or not apply a NQTL to which that factor relates] has the meaning stated in 45 C.F.R. §146.136(a).

[(5)] (4) “Factor” [means a circumstance, condition, fact, standard, criterion, influence, or any other consideration that contributes to the development, design, or implementation of a NQTL] has the meaning stated in 45 C.F.R. §146.136(a).

[(6)] (5)—[(13)] (12) (text unchanged)

[(14)] (13) “Process” [means a series of actions or steps taken during the development, design, or implementation/application of a NQTL] has the meaning stated in 45 C.F.R. §146.136(a).

(14) “Product” has the meaning stated in Insurance Article, §15-1309(a)(3), Annotated Code of Maryland.

(15)—(16) (text unchanged)

(17) “Strategy” has the meaning stated in 45 C.F.R. §146.136(a).

[(17)] (18)—[(18)] (19) (text unchanged)

.04 Filing of Nonquantitative Treatment Limitation Comparative Analysis Report.

A. For [the five health benefit plans with the highest enrollment for] each product offered by the carrier in the individual, small, and large group markets, a carrier that delivers or issues for delivery a health benefit plan in the State shall file a comparative analysis for each nonquantitative treatment limitation [specified] selected by the Commissioner in accordance with Insurance Article, §15-144 (c)(5), Annotated Code of Maryland, in the form required by the Commissioner, to demonstrate the carrier’s compliance with the Parity Act, in accordance with Insurance Article, §15-144(c)—(e), and (g), Annotated Code of Maryland. An analysis report shall be filed with the Commissioner using only the form developed by the Commissioner and posted on the Administration’s website.

B. If, for any plan within a product described in §A of this regulation, the processes, strategies, evidentiary standards, or other factors used in designing and applying the selected NQTLs to MH/SUD benefits and M/S benefits are different, as written or in operation, from the other plans within the product, the carrier shall submit a separate comparative analysis for the selected NQTLs for the plan, and the statement required by Insurance Article, §15-144(c)(3)(iii) shall note the exception and identify the plan.

C. A carrier shall submit the data templates described in Insurance Article, §15-144(f), Annotated Code of Maryland, in the form required by the Commissioner.

D. The analysis reports described in §§A—C of this regulation shall be submitted on or before July 1, 2024, and every 2 years thereafter.

[B.] E. — [D.] G. (text unchanged)

[E.] H. Each analysis report shall contain [a statement, signed by a corporate officer, attesting to the accuracy of the information contained in the analysis report] the statements required by Insurance Article, §15-144(c)(3)(iii) and (g)(4), Annotated Code of Maryland.

[F.] I. Failure to file a complete analysis report shall [result in penalties described in] constitute noncompliance with the Parity Act and the Commissioner will have authority to act in accordance with the provisions of Insurance Article, §15-144 (j), Annotated Code of Maryland.

[G.] J. Complete Analysis Report.

(1) The analysis required by Insurance Article, §15-144(d), Annotated Code of Maryland, shall have been performed for [processes] NQTLs in place during the calendar year preceding the analysis report.

(2)—(3) (text unchanged)

(4) The analysis reports shall include the following information to be considered complete:

(a) All of the information identified in Insurance Article, [§15-144(e)], §15-144(d)-(f), Annotated Code of Maryland, in the manner and format specified in the standard reporting form and associated instructions provided on the Administration’s website;

(b) A response to each step listed in the reporting form, for each NQTL selected in accordance with Insurance Article, §15-144 (c)(5), Annotated Code of Maryland in each classification and sub-classification, as applicable. If a particular item in a step is not applicable (for example, if none of the factors used to determine that the NQTL will apply to a benefit was given more weight than another), an explanation shall be provided as to why the item is not applicable;

(c) A statement as to whether there is any variation in the design or application of a guideline or standard used by the carrier between MH/SUD and medical/surgical benefits, and, if so, a description of the factors and process used for establishing that variation. Specific definitions of factors, processes, or criteria used to establish or support any variation is required. Any practice guidelines that may be associated with the NQTL shall also be provided;

(d) If the design or application of the NQTL turns on specific decisions in the administration of the benefits, identification of the basis of the decisions, the decision maker or makers, the timing of the decisions, and the qualifications of the decision maker or makers, including expertise and specialty;

(e)—(g) (text unchanged)

(h) Documentation of audits, reviews, and analyses to check sample claims or other administrative data to assess how each NQTL operates in practice, and whether written processes are correctly carried out, including the results of the audits and reviews performed on the NQTLs [identified] selected in accordance with Insurance Article, [§15-144(c)(2)(ii)] §15-144(c)(5), Annotated Code of Maryland, to conduct the comparative analysis required under Insurance Article, §15-144 (d)(2), Annotated Code of Maryland, as written, and in operation;

(i) Citations to any documents, studies, testing, claims data, or reports that include factors, sources, evidentiary standards, or other evidence relied upon in developing or applying the NQTL (for example, meeting minutes or reports showing how those considerations were applied), with copies of those items available on request; and

(j) (text unchanged)

[.06] .05 Summary Form.

A. (text unchanged)

B. The summary form shall be made available to plan members and accessible to the public on the carrier’s website no later than [April 1, 2022 and April 1, 2024] 30 days following the due date of each analysis report. The carrier shall make the summary form available to plan members in response to a written request within 30 days of the request.

C.—D. (text unchanged)

[.07] .06 Compliance Plan.

A. If, as a result of the review of the reports described in [Regulations .02 and .03] Regulation .04 of this chapter, the Commissioner finds that a carrier subject to Insurance Article, §15-144, Annotated Code of Maryland, failed to comply with provisions of the Parity Act, the Commissioner shall notify the carrier and require the carrier to submit a compliance plan pursuant to Insurance Article, §15-144(i), Annotated Code of Maryland, to correct the noncompliance. The notice shall be in writing, but may be transmitted electronically.

B.—C. (text unchanged)

MARIE GRANT

Acting Insurance Commissioner

Errata

COMAR 11.04.17.04

At 52:9 Md. R. 412 (May 2, 2025), column 2, following line 3 from the top:

Insert: B. (text unchanged)

[25-10-14]

COMAR 25.03.03.02

At 52:4 Md. R. 222 (February 21, 2025), column 2, line 3 from the bottom:

For: Annotated Code of Maryland.]

COMAR 25.03.03.02

At 52:4 Md. R. 222 (February 21, 2025), column 2, line 3 from the bottom:

For: Annotated Code of Maryland.]

Read: Annotated Code of Maryland.

[25-10-16]

Special Documents

DEPARTMENT OF THE ENVIRONMENT

SUSQUEHANNA RIVER BASIN COMMISSION

Commission Meeting

AGENCY: Susquehanna River Basin Commission.

ACTION: Notice.

SUMMARY:  The Susquehanna River Basin Commission will conduct its regular business meeting on June 4, 2025 in Harrisburg, Pennsylvania.  Details concerning the matters to be addressed at the business meeting are contained in the Supplementary Information section of this notice. Also, the Commission published a document in the Federal Register on March 28, 2025 concerning its public hearing on April 24, in Harrisburg, Pennsylvania.

DATES: The meeting will be held on Wednesday, June 4, 2025 at 2:30 p.m.

ADDRESSES: This public meeting will be conducted in person and digitally from the Susquehanna River Basin Commission at 4423 North Front Street, Harrisburg, Pennsylvania.

FOR FURTHER INFORMATION CONTACT: Jason E. Oyler, General Counsel and Secretary to the Commission, telephone: 717-238-0423; fax: 717-238-2436.

SUPPLEMENTARY INFORMATION: The business meeting will include actions or presentations on the following items: 1) Adoption of an updated Dry Cooling Resolution; 2) Adoption of the FY2026 Budget Reconciliation; 3) Approval of contract and grants; 4) Adoption of a Policy on the Acceptance of Gifts and Other Funds; 5) Adoption of the Annual Update to the Water Resources Program; and 6) 27 actions on 18 regulatory program projects.

This agenda is complete at the time of issuance, but other items may be added, and some stricken without further notice. The listing of an item on the agenda does not necessarily mean that the Commission will take final action on it at this meeting. When the Commission does take final action, notice of these actions will be published in the Federal Register after the meeting. Any actions specific to projects will also be provided in writing directly to project sponsors.

The meeting will be conducted both in person and digitally at the Susquehanna River Basin Commission, 4423 North Front Street, Harrisburg, Pennsylvania. The public is invited to attend the Commission’s business meeting. The public may access the Business Meeting remotely via Zoom :
https://us02web.zoom.us/j/81256961855?pwd=JjtXeSxCauchJQlToIUFaqxovbT55N.1 Meeting ID 812 5696 1855;

Passcode: SRBC4423! or via telephone: 929-436-2866 or 301-715-8592.

A public hearing and written comment period was provided for the actions on the 18 projects and the comment period on those proposed actions is closed. Written comments pertaining to all other items on the agenda at the business meeting may be mailed to the Susquehanna River Basin Commission, 4423 North Front Street, Harrisburg, Pennsylvania 17110-1788, or submitted electronically at the link Business Meeting Comments. Comments are due to the Commission for all items on the business meeting agenda on or before June 2, 2025. Comments will not be accepted at the business meeting noticed herein.

Authority: Pub. L. 91-575, 84 Stat. 1509 et seq., 18 CFR Parts 801, 806, and 808.

Dated: April 30, 2025

Jason E. Oyler,

General Counsel and Secretary to the Commission

[25-10-13]

WATER AND SCIENCE ADMINISTRATION

Water Quality Certification Request 25-WQC-0011 &

Federal Consistency Determination Request

U.S. Army Corps of Engineers, Baltimore District

2 Hopkins Plaza

Baltimore, MD 21201

Add’l. Info: Pursuant to COMAR 26.08.02.10F(1)(d), The Maryland Department of the Environment is providing notice of a request for Water Quality Certification (25-WQC-0011).

Location: Waters of the United States, including wetlands and navigable waters, within the State of Maryland except: Back Creek (of the Chesapeake and Delaware Canal), east of a line extending from Welch Point to Courthouse Point to the Delaware line and to the Second Street Bridge to the south; Herring Creek east of the line extending from Welch Point to Courthouse Point to the dam that crosses Herring Creek; and Long Branch to the Boat Yard Road Bridge to the north, including jurisdictional wetlands adjacent and contiguous to these tidal waterways.

The U.S. Army Corps of Engineers, Baltimore District, has requested a Water Quality Certification (WQC) under Section 401 of the Clean Water Act for the proposed modified reissuance of the Maryland State Programmatic General Permit-6 (MDSPGP-6) as the Maryland State Programmatic General Permit-7 (MDSPGP-7), for a five year period. The WQC application is for MDSPGP-7 activities that may result in a discharge of dredged and/or fill material in waters of the United States, including wetlands and navigable waters, within the State of Maryland. A federal consistency determination has also been requested in accordance with the Coastal Zone Management Act (CZMA) for this activity.

A copy of the current version of the MDSPGP that expires on September 30, 2026 can be viewed on the U.S. Army Corps of Engineers webpage at: https://www.nab.usace.army.mil/Portals/63/MDSPGP-6%20Permit%20Final%20with%20Appendicies%2020210930.pdf

The draft MDSPGP-7 is also available at: https://www.nab.usace.army.mil/Portals/63/docs/Regulatory/PN/NEW_MDSPGP-7%20Initial%20Draft_20241106_dwnld20241202_rev%20for%20PN.pdf?ver=wOazDyIwcB3FHgZToR0JZg%3d%3d

The WQC request, CZMA federal consistency determination, and supporting information, including the Department’s public notice, is available on the Department’s website at the following link: https://mde.maryland.gov/programs/water/WetlandsandWaterways/Pages/MDSPGP-7-Reissuance.aspx. Any project updates or decisions will be posted on this webpage.

The purpose of this notice is to solicit comments from the public about the proposed issuance of the MDSPGP-7. Arrangements may be made for inspection and copying of file materials. Interested parties may provide written comments on the requests or request an informational hearing. A request for a hearing must be in writing and include the following information: 1) Name, Address, and Telephone Number of the person making the request; 2) the identity of any other person(s) the requestor is representing; and 3) the specific issues proposed to be considered at the hearing related to water quality. Any person or party interested in commenting or requesting a hearing is requested to submit comments and requests to Alex Vazquez, Wetlands and Waterways Program, Water and Science Administration, Maryland Department of the Environment, 1800 Washington Blvd., Ste. 430, Baltimore, MD 21230, or email comments to alex.vazquez@maryland.gov or by phone at (410) 537-3541. Comments and/or a request for hearing must be received on or before June 16th, 2025 at 5:00 PM..

Contact: Alex Vazquez at alex.vazquez@maryland.gov or 410-537-3541.

DEPARTMENT OF STATE POLICE

HANDGUN ROSTER BOARD

Handgun Roster Restriction Addition

The KEL-TEC PR57 appeared in the March 21st issue of the Maryland Register and, after 30 days with no objection filed, was included on the Maryland Handgun Roster on April 20th as an approved firearm. Under CR 4-301(h)(1)(iv), the KEL-TEC PR57 would meet the definition of a "Copycat Weapon" because it is a semiautomatic pistol with a fixed magazine that can accept more than 10 rounds. The firearm will be listed on the Handgun Roster with a restriction of sales to Law Enforcement Agencies or US Military only. Please note, the firearm is not authorized for sale to the general public or to law enforcement / U.S. Military members. The only exemption for sale would be to personnel if acting within the scope of official business, personnel of the United States government or a unit of that government, members of the armed forces of the United States or of the National Guard, law enforcement personnel of the State or a local unit in the State, or a railroad police officer authorized under Title 3 of the Public Safety Article or 49 U.S.C. § 28101.

Any questions regarding the roster can be addressed to the Handgun Roster Board Administrator, Ms. Rachel Rosenberg (410-653-4247).

[25-10-08]

General Notices

Notice of ADA Compliance

The State of Maryland is committed to ensuring that individuals with disabilities are able to fully participate in public meetings. Anyone planning to attend a meeting announced below who wishes to receive auxiliary aids, services, or accommodations is invited to contact the agency representative at least 48 hours in advance, at the telephone number listed in the notice or through Maryland Relay.

Issue Date	Emergency and Proposed Regulations 5 p.m.*	Notices, etc. 10:30 a.m.	Final Regulations 10:30 a.m.
May 30	May 12	May 19	May 21
June 13	May 23**	June 2	June 4
June 27	June 9	June 16	June 18
July 11	June 23	June 30	July 2
July 25	July 7	July 14	July 16
August 8	July 21	July 28	July 30
August 22	August 4	August 11	August 13
September 5	August 18	August 25	August 27
September 19	August 29**	September 8	September 10
October 3	September 15	September 22	September 24
October 17	September 29	October 6	October 8
October 31	October 10**	October 20	October 22
November 14	October 27	November 3	November 5
December 1***	November 10	November 17	November 19
December 12	November 24	December 1	December 3
December 26	December 8	December 15	December 17