.01 License — General.

A. General Requirements.

(1) A person shall obtain a license from the Secretary before performing or offering to perform a forensic analysis in this State.

(2) A person may not perform or offer to perform forensic analysis without first obtaining a forensic laboratory license from the Secretary.

(3) Letter of Permit Exception.

(a) The Secretary may grant an individual a letter of permit exception if:

(i) The individual is not affiliated with a public or commercial laboratory that performs forensic analyses;

(ii) The application for the letter of permit exception is limited to an individual performing limited forensic analysis in a discipline or subdiscipline; and

(iii) The individual applying for the letter of permit exception has documentation that demonstrates the individualís competency and experience in the specific forensic discipline or subdiscipline in which the forensic analysis will be performed.

(b) The individual who will perform the forensic analysis shall:

(i) Submit an application for a letter of permit exception to the Department for approval;

(ii) Renew a letter of permit exception every 3 years from the date of issuance, if renewal is desired;

(iii) Be subject to oversight by the Department; and

(iv) Be subject to the sanctions set forth in COMAR 10.51.07.

(4) Waiver.

(a) The Secretary may grant to a forensic laboratory not located in this State, a waiver from the licensing requirements of this subtitle if:

(i) The forensic analysis or examination is not performed by a licensee;

(ii) The waiver is limited to a single case or related cases; and

(iii) The person requesting the waiver has documentation that demonstrates the forensic laboratoryís competency and quality.

(b) A licensee, a party to a criminal case or related cases, or the forensic laboratory that has been requested to perform a forensic analysis shall:

(i) Submit a request for a waiver for approval by the Department; and

(ii) Make requests in accordance with the process established by the Department.

(c) The Department may require an out-of-State laboratory that has been waived for licensure to apply for licensure based on the number of waivers issued to that laboratory by the Department.

(d) The Department may deny a waiver if:

(i) The Department determines the laboratory has been the subject of frequent waiver requests and the laboratory has failed to apply for licensure; or

(ii) The laboratoryís license application was denied or its license was suspended or revoked by the Department.

(5) Prohibited Analyses. The Secretary may impose principal and alternative sanctions as set forth in this subtitle if a person performs or offers to perform a forensic analysis or part of a forensic analysis, including the use of a reagent, supply, procedure, method, technique, kit, or equipment, that:

(a) Does not produce accurate or reliable forensic analysis results as evidenced by documented, independent scientific testing and evaluation; or

(b) Lacks proof of efficacy substantiated by independently conducted and documented scientifically based evidence.

B. Limitation. A person may not operate a forensic laboratory in a forensic science discipline or subdiscipline other than what is listed on the license unless it is a discipline or subdiscipline listed under COMAR .

C. Application Eligibility. A person meeting the requirements and standards of this subtitle and the requirements set forth in Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, may apply for a forensic laboratory permit.

D. Issuance.

(1) Permit. The Secretary may issue a permit that:

(a) Is valid for not more than 3 years from the date of issue; and

(b) Shall be renewed before the date of expiration if a person intends to operate the forensic laboratory in the succeeding permit period.

(2) Site License Required. A person shall obtain a separate license for each location at which the person maintains a site to perform forensic analyses.

E. In order to maintain a State license issued by the Department pursuant to this subtitle, a licensee shall be in compliance with all applicable federal, State, and local requirements.