This rule establishes certification requirements for Syringe Services Programs (SSPs) in Maine, which are community-based harm reduction programs that exchange used syringes for sterile ones, distribute overdose prevention equipment, and provide referrals to substance use disorder treatment and infectious disease services. Operators must submit a detailed application including consumer confidentiality protocols, staff training plans, disposal plans, and data collection procedures. Certified SSPs must follow specific operating requirements such as one-for-one syringe exchange policies, prohibition on distributing to minors, staff identification requirements, and data reporting obligations. The rule also covers department administration including certification review, suspension or revocation, inspections, and appeals.
View official sourceSTATE OF MAINE SYRINGE SERVICES PROGRAMS RULE 10-144 CODE of MAINE RULES Chapter 252 DEPARTMENT of HEALTH and HUMAN SERVICES MAINE CENTER for DISEASE CONTROL and PREVENTION Last Amended: March 8, 2026 TABLE OF CONTENTS SECTION 1. PURPOSE AND GENERAL DEFINITIONS 1 A. Purpose 1 B. Definitions 1 SECTION 2. APPLICATION FOR CERTIFICATION 3 A. Filing of Application 3 B. Application for SSP Modifications 3 C. Application Review 3 D. Contents of Application 3 E. Additional Application Information 5 F. Suitability of Applicant 5 SECTION 3. CERTIFIED SYRINGE SERVICES PROGRAM OPERATIONS 7 A. Operating Requirements 7 B. SSP Notification 7 C. Data Collection and Reporting 8 D. Recordkeeping 8 E. Posting of Certification 9 SECTION 4. DEPARTMENT ADMINISTRATION 9 A. Refusal to Certify 9 B. Suspension of Revocation of Certification 9 C. Right of Inspection 10 D. Length of Certification 10 E. Appeals Procedure 10 F. Non-Transferable Certification 10 STATUTORY AUTHORITY 11 SECTION 1. PURPOSE AND GENERAL DEFINITIONS A. Purpose. This rule establishes requirements for certification as a hypodermic apparatus exchange programs or “Syringe Services Program,” as authorized by 22 M.R.S. § 1341. B. Definitions. As used in this rule, the following terms have the following meanings: 1. Applicant means the Syringe Service Program (SSP) or prospective Syringe Service Program applying for certification or recertification or seeking program modifications pursuant to this rule. 2. Administrator means a person having the authority and responsibility for the operation of the Syringe Services Program and for staff performance. 3. Brick-and-Mortar Site means, for the purposes of this rule per 22 M.R.S. § 1341 (5), a type of service model for the provision of Syringe Services to Consumers within a permanent building located within an Operation Area. 4. Certification Review Team means the stakeholder group charged with reviewing SSP applications. Membership may include subject matter experts who represent the following: the Maine Department of Health and Human Services (“Department”) Maine Center for Disease Control and Prevention (“Maine CDC”); the Maine Department of Health and Human Services Office of Behavioral Health; the Maine Association of Chiefs of Police; the Maine Department of Public Safety; the Maine Department of Labor Bureau of Labor Standards; the Maine Drug Enforcement Agency; HIV Prevention service providers and Consumer representatives. Maine CDC’s Director or designee will appoint appropriate members of the Certification Review Team to review applications for certification of Syringe Services Programs. 5. Certified Syringe Services Program means a Department-approved community-based Syringe Services Program (SSP) that offers harm reduction and Syringe Services that may include exchanging a Consumer’s used syringes for sterile syringes, distributing overdose prevention equipment, testing for sexually transmitted diseases and blood borne infectious diseases, assisting Consumers with referrals for social support and assistance programs, distributing safer sex supplies, and providing public health education. Any Program certified pursuant to 22 M.R.S. § 1341 includes all approved Sites, service models and staff of the SSP. 6. Consumer means a person eighteen (18) years of age or older who is enrolled in a Syringe Services Program. 7. Consumer Confidentiality Protocol means the SSP’s written protocol which strictly limits the disclosure of Consumer identification information and Consumer HIV status. 8. Consumer Education and Referral Plan means the SSP’s written plan for educating Consumers on preventing and treating HIV, Viral Hepatitis and other blood borne pathogens, and substance use disorder treatment, and for describing how the SSP will refer Consumers to appropriate services. 9. Delivery Services means, for the purposes of this rule per 22 M.R.S. § 1341 (5)(B), a type of service model for the provision of hypodermic apparatuses to Consumers within an Operation Area. 10. Department means the Maine Department of Health and Human Services Maine Center for Disease Control and Prevention (Maine CDC). 11. Exchange Event means the Consumer’s encounter with a Syringe Services Program to exchange one or more used syringes for sterile syringes or to receive any other Syringe Services. 12. Hypodermic Apparatus means a syringe used with a hollow needle for the injection of material beneath the skin. 13. Mobile Site means, for the purposes of this rule per 22 M.R.S. § 1341 (5)(A), a type of service model for the provision of Syringe Services in the community that may include temporary setups, rotating locations at set or variable schedules within the Operation Area. 14. Needle or Syringe Disposal Plan means the SSP’s written plan which describes a coordinated program for the terminal disposal and incineration of used syringes. 15. New Enrollee means a person eighteen (18) years of age or older who enrolls into a Syringe Services Program for the first time. If a Consumer exits or is disenrolled from a Syringe Services Program and re-enrolls at a later time, that person will be considered a “New Enrollee.” 16. Operation Area means the Sites and geographic territory where the certified SSP is approved by the Department to operate and provide Syringe Services. 17. Policy and Procedures Manual means the written resource detailing the SSP’s protocols to guide its SSP Staff. Components of the Manual are listed in Section 3 (Operating Requirements) of this rule. 18. Program Data Collection Protocols mean the SSP’s written procedures for collecting and reporting data in accordance with this rule. Data required for reporting is listed in Section 3 of this rule. 19. Public Notice means written notice issued via certified mail to local or county law enforcement, substance use disorder treatment providers and infectious disease prevention service providers within the proposed Operation Area, and the chief municipal officer of each municipality (i.e. the mayor, city or town manager, or other top executive of the municipality) where the SSP proposes to serve, of a Applicant’s intent to establish a Syringe Services Program in the community, including an explanation of the public health goals of the SSP and planned service locations and delivery models, and that serves as an invitation to participate in the implementation of the SSP. 20. Site means the location(s) or venue(s) where the Syringe Services Program is seeking certification or certified to offer services to Consumers. 21. Staff means anyone involved in providing Syringe Services on behalf of a certified Syringe Services Program. 22. Staff Training Plan means a written plan established and maintained by a Certified SSP, in accordance with Operating Requirements in Section 3 of this rule. 23. Syringe means, for the purposes of this rule, the same as “hypodermic apparatus”, as used in 22 M.R.S. § 1341 and defined at Section 1(12)) of this rule. 24. Syringe Services means services provided in person by a certified hypodermic apparatus exchange program (22 M.R.S. § 1341), which may include, but is not limited to, receiving in person new syringes, referrals, and educational materials about prevention, treatment, and proper disposal of syringes. SECTION 2. APPLICATION FOR CERTIFICATION A. Filing of Application Any person who intends to apply to the Department for certification of the Syringe Services Program must be the individual who has ultimate responsibility for ensuring SSP operations for compliance with this rule. To apply for certification to operate a Syringe Services Program, the Applicant must, prior to the commencement of such operation, submit the application in the form and manner prescribed by the Department. Applications submitted on behalf of a corporation or association must be made by any two officers thereof or by the Administrator of the SSP. Applicants must submit one copy of the complete application to the Department for review and approval. B. Application for SSP Modifications Certified SSPs seeking to relocate to a new Site, add any new Site, or expand the Operation Area must submit a complete application in accordance with the procedure set forth in Section 2 of this rule. C. Application Review The Certification Review Team will review each application and, within thirty (30) working days, forward the team’s advisory recommendations to the Director of the Maine CDC. The Director will issue a final decision regarding certification within ten (10) working days of receipt of the Certification Review Team’s recommendations. The Director or Department designee will send notice of the SSP certification decision to the Applicant, Maine Department of Public Safety, the Maine Drug Enforcement Agency and the local or county law enforcement, within ten (10) working days of Department’s decision regarding certification or change in certification. D. Contents of Application Each application must contain: 1. The name by which the SSP is to be legally known and the name under which it will be doing business. 2. For proprietary corporations: the full name and address of each person, firm or corporation having (directly or indirectly) an ownership interest of 5% or more in the SSP; 3. For business entities with one owner or business partnerships: the full name and contact information for the owner and each partner; 4. For not-for-profit organizations: the full name and contact information for the President of the Board of Directors or appropriate municipal government representative; 5. The name and contact information for the individual designated by the applicant as the Administrator of the SSP. 6. A description of all service models offered by the SSP, in accordance with 22 M.R.S. § 1341 (5), including any Site location(s), as applicable. For Brick-and-Mortar Sites: This description must include the building address(es) and contact information of the owner(s) of each building utilized by the SSP. For Mobile Sites: This description must identify the address of each location or venue temporarily set-up for SSP operations, and the name and contact information of the Administrator. For Delivery Services: This description must identify the intended area where hypodermic apparatuses may be lawfully delivered. The hours of operation for each service model. An approved letter of registration with a valid biomedical waste generator number from the Maine Department of Environmental Protection, to demonstrate compliance with hazardous waste law (38 M.R.S. §1319-O (3)) and any applicable rules for the handling and disposal of biomedical waste. Written documentation that SSP operations comply with all municipal zoning ordinances within the Operation Area. Examples include a notice from a town manager or municipal officer such as Code Enforcement or Planning Board, verifying that the Site is suitable for use and does not violate applicable municipal zoning ordinances or local permit or land use laws, and a map showing how SSP operations comply with all applicable municipal zoning ordinances, local regulations, and this rule. Email or images demonstrating proof of delivery of Public Notice. Attestation that the Program’s operations comply or will comply with this rule. E. Additional Application Information Each application must also include any applicable internal policies and, minimally, the following documents: 1. A copy of the Applicant/SSP’s Consumer Confidentiality Protocol. 2. A copy of the Applicant/SSP’s Consumer Education and Referral Plan which must include a list of the following resources: substance use disorder treatment providers, social service providers and HIV and Viral Hepatitis service and treatment providers available in the area the Syringe Services Program serves. 3. A copy of the Applicant/SSP’s Needle or Syringe Disposal Plan which demonstrates compliance with the Occupational Safety and Health Administration’s guidelines regarding Occupational Exposure to Bloodborne Pathogens and the Safe Discarding and Containment of Contaminated Sharps under 29 CFR §1910.1030. 4. A copy of the Applicant/SSPP’s Staff Training Plan which complies with the Occupational Safety and Health Administration’s guidelines regarding Occupational Exposure to Bloodborne Pathogens and the Safe Discarding and Containment of Contaminated Sharps under 29 C.F.R. §1910.1030 and the Maine CDC Privacy Policy. 5. A copy of the Applicant/SSP’s Data Collection Protocols. 6. Proof of Public Notice. 7. A copy of the Program’s Policy and Procedures Manual. F. Suitability of Applicant In acting upon any application for SSP certification, the Department will determine the suitability of the Applicant to operate a Syringe Services Program by evaluating: 1. Whether the Applicant demonstrates a willingness and ability to operate and manage the Program in compliance with this rule and all relevant laws. In making this determination, the Department will consider each of the following factors: a. Applicant’s record and reputation for lawful conduct in business and personal affairs of the corporation, the Administrator and the management staff over the previous five (5) years, including, but not limited to, any criminal conviction(s). b. Information which relates to the ability of the SSP to comply with all applicable laws and regulations. c. Any information reasonably related to the SSP’s ability to provide safe services to the public. d. Management and oversight experience, including the capacity to manage SSP general operations and staff. e. Experience in the field of health care, public health, social services or areas related to the provision of HIV or substance use disorder prevention and treatment. f. Conduct which demonstrates an understanding of, and compliance with, consumers’ rights and confidentiality. SECTION 3. CERTIFIED SYRINGE SERVICES PROGRAM OPERATIONS A. Operating Requirements. In operating a Certified Syringe Services Program: 1. SSPs must adhere to a distribution policy that allows the one-for-one exchange of a used syringe for each sterile syringe provided to the Consumer. In instances where the Consumer cannot offer a used syringe to be exchanged, a Program may provide a Consumer with new syringes, as needed, but may not exceed 100 syringes per Consumer per encounter. 2. The SSP may further limit the number of syringes provided to each Consumer in accordance with its Policy and Procedures Manual. 3. SSP enrollment of Consumers must be in accordance with the SSP’s Policy and Procedure Manual, and a Consumer may enroll in more than one SSP. 4. SSPs may provide Syringe Services within its Operation Area, including Delivery Services, to enrolled Consumers, regardless of where the Consumer resides. 5. SSPs may not knowingly distribute syringes to persons younger than 18 years of age. 6. SSPs must comply with all applicable Maine Statutes and rules, and local regulations, as applicable. 7. SSPs may furnish sterile syringes to a New Enrollee when the enrollee exchanges used syringes for sterile syringes or disposal. However, a syringe exchange is not required by this rule. 8. SSP staff may not accept remuneration directly from Consumers for providing hypodermic apparatuses. 9. SSP staff must carry identification and a copy of the SSP certification document while conducting SSP operations and outreach in the community. The copy of the Certification must identify the SSP’s Operating Area. 10. SSP Consumer enrollment guidelines must require the SSP to notify all Consumers of rules and laws applicable to Syringe Services Programs. 11. Syringe Services Program staff must be trained in confidentiality protocols and bloodborne pathogen infection control, including post-exposure protocols. Staff training must also include HIV-prevention education, substance use disorder treatment education, and any and all training necessary for the safe and lawful operation of a Syringe Services Program. 12. SSPs must provide Syringe Services, including Delivery Services, in a manner that: Demonstrates effective understanding of all training protocols described in Section 3(A)(11) of this rule, Ensures appropriate protections of Consumers’ confidentiality, and c. Facilitates the safe handling and proper disposal of syringes. SSPs may only provide Delivery Services of hypodermic apparatuses under the following conditions, per 22 M.R.S. § 1341 (5)(B): Delivery is made to locations within the SSP’s approved Operation Area; The SSP ensures client confidentiality; The SSP ensures safe handling of all hypodermic apparatuses during delivery; The SSP ensures proper disposal of used hypodermic apparatuses; Any individuals or entities expressly inviting the SSP to deliver hypodermic apparatuses have the legal authority to do so; The location for delivery of the hypodermic apparatuses is outside of 1,000 feet from any primary or secondary school property; and This rule or any applicable Maine law does not otherwise prohibit SSP delivery of the hypodermic apparatuses to the location. 14. SSPs must comply with all terms of any contractual agreement with the Department to remain certified. 15. SSPs must comply with this rule and all terms of any contractual agreement with the Department to be eligible for State funds. (22 M.R.S. § 1341 (4)). B. SSP Notification Each SSP must notify the Department in writing within two (2) business days of any changes regarding the following: 1. Ownership; 2. SSP contact telephone number; 3. Administrator, management, or staff of the Program, excluding volunteers; 4. Operating hours; and 5. Policy and Procedures Manual. C. Data Collection and Reporting Each Certified Syringe Services Program must submit utilization data in the aggregate to the Department no less frequently than monthly, using the electronic system prescribed by the Department. (22 M.R.S. § 1341 (3)). The following data are required by site: Demographic information reported by Consumers served by the SSP including age, race, ethnicity, sex and gender; The number of syringes collected, distributed and disposed of; The number of Consumers receiving Syringe Services; The number of referrals made to HIV service and treatment providers; The number of Consumers who received an HIV test through the SSP; The number of tests administered for HIV and for hepatitis C; The number of referrals made to substance use disorder treatment providers; The number of New Enrollees receiving sterile syringes without exchange at enrollment; The number of syringes distributed to New Enrollees without exchange at enrollment; and Any additional data elements determined necessary by the Department to inform on program utilization and compliance with this rule. Additionally, the Department may require SSPs to assist with data quality activities and reporting, as needed, to ensure data is accurate and reliable. D. Recordkeeping. SSPs must maintain and make available to the Department upon request the following: 1. SSP Policy and Procedure Manual that includes the following components: Confidentiality safeguards; Safety procedures, including demonstration of proper bloodborne pathogen protocols and exposure protocols; c. Referral services for Consumers; d. Complaint procedures; and e. Consumer enrollment and termination procedures. 2. Copy of SSP application approved for current Certification; 3. A current record of locations of operating Sites; 4. Operating hours for all Syringe Service models offered by the SSP, including Delivery Services; 5. A record of staff names; and 6. Record of any grievance or complaint reported to the Program and related findings, as a result of the investigation. E. Posting of Certification The Certification granted by the Department must be conspicuously posted in Brick- and-Mortar Sites and offices of the Administrator of the SSP. SECTION 4. DEPARTMENT ADMINISTRATION Refusal to Certify The Department may refuse certification of an Applicant if any of the following conditions exist: 1. Incorrect or incomplete information submitted in the SSP’s application; 2. The applicant does not meet all the requirements of applicable laws and regulations, including requirements of this rule; or 3. The Applicant or Applicant’s Administrator and management staff have violated specific laws, rules, and regulations pertaining to, or in connection with, the operation of a Syringe Services Program in the five (5) years preceding date of application. B. Suspension or Revocation of Certification 1. The Department may suspend or revoke any certification issued pursuant to 22 M.R.S. § 1341 for: a. Violation of applicable laws, regulation and rules, or contractual agreements; or b. Conduct committing, permitting, aiding or abetting any illegal practices in the operation of a Syringe Services Program; or c. Conduct detrimental to the welfare of the Consumers enrolled in a Syringe Services Program. 2. The Department will mail its decision to suspend or revoke Certification to the Program’s last known mailing address. 3. Upon suspension or revocation of a Certification, the Administrator must immediately surrender the Certification to the Department and cease all operations. 4. The Department will inform local law enforcement, the chief municipal officer of each municipality (i.e. the mayor, city or town manager, or other top executive of the municipality) where the SSP was certified, and Certification Review Team members of the revocations of, or changes in, Program Certification within ten (10) days. C. Right of Inspection Any duly designated employee of the Department must be permitted access to Program records and enter upon and into the premises of any certified Syringe Services Program. 1. The Department may inspect relevant SSP documents to determine whether the SSP complies with this rule. It is within the sole discretion of the Department to determine whether to announce inspections conducted for compliance purposes or in response to a complaint. 2. The SSP must afford full access to the Department to examine and copy all records, documents and reports required for recordkeeping by the certified SSP under this rule, at no expense to the Department. D. Length of Certification 1. The Department may certify SSPs for a period not to exceed five (5) years, pursuant to 22 M.R.S. § 1341 (2)(H). The Department may renew certification every five years, provided the SSP demonstrates continued compliance and suitability, upon the SSP’s application in accordance with Section 2 of this rule. 2. A Certification will be considered valid until it expires or is suspended or revoked by the Department. 3. Suspension or revocation may void the contract between the SSP and the Department. E. Appeals Procedure Any person aggrieved by the Department’s decision to deny, suspend or revoke Certification to a Program or SSP applicant may request a hearing as provided by the Maine Administrative Procedure Act, 5 M.R.S. Chapter 375, Subchapter 4. A request for a hearing must be made in writing within thirty (30) days of the date that the Department’s decision was issued. The request for hearing must be made in writing to the Maine CDC and must state clearly the reason(s) for the request. F. Non-Transferable Certification No SSP certification may be assigned or transferred. STATUTORY AUTHORITY: 22 M.R.S. § 1341(2) EFFECTIVE DATE: Forms specify July 15, 1998; filing received June 26, 1998 – as “Rules Governing the Implementation of Hypodermic Apparatus Exchange Programs” AMENDED: July 1, 2009 – filing 2009-241 September 1, 2022 – filing 2022-168 (EMERGENCY) – as “Syringe Services Programs Rule” November 30, 2022 - filing 2022-229 APAO ACCESSIBILITY CHECK (Word): March 3, 2026 AMENDED: March 8, 2026 - filing 2026-059