<?xml version='1.0' encoding='utf-8'?>
<subtitle num="12" heading="Radiation Management" title_num="26" title_heading="Department of the Environment">
  <chapter num="01" heading="Radiation Protection">
    <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference.">
      <text>All provisions of the Regulations for the Control of Ionizing Radiation (1994) as amended by Supplement 1 through Supplement 35 are incorporated by reference.</text>
    </regulation>
    <annotations>
      <annotation type="Authority">Environment Article, §§8-106, 8-301, and 8-304, Annotated Code of Maryland</annotation>
      <annotation type="History" subtype="Administrative History">Effective date: February 4, 1976 (3:3 Md. R. 150)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 25, 1977 (4:11 Md. R. 866)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .01 repealed and new Regulation .01 adopted effective December 6, 1982 (9:24 Md. R. 2390)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .01 amended effective September 21, 1986 (13:19 Md. R. 2121); October 9, 1995 (22:20 Md. R. 1546)</annotation>
      <annotation type="History" subtype="Administrative History">COMAR 10.14.02.01 recodified to COMAR 26.12.01.01</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .01 amended effective December 16, 1996 (23:25 Md. R. 1787); November 3, 1997 (24:22 Md. R. 1552); June 29, 1998 (25:13 Md. R. 997); December 28, 1998 (25:26 Md. R. 1926); June 14, 1999 (26:12 Md. R. 926); February 7, 2000 (27:2 Md. R. 149); April 1, 2002 (29:6 Md. R. 570); October 13, 2003 (30:20 Md. R. 1448); October 27, 2003 (30:21 Md. R. 1530); March 29, 2004 (31:6 Md. R. 510); June 7, 2004 (31:11 Md. R. 858); June 20, 2005 (32:12 Md. R. 1048); December 8, 2005 (32:24 Md. R. 1906); October 9, 2006 (33:20 Md. R. 1617); December 17, 2007 (34:25 Md. R. 2216); June 15, 2009 (36:12 Md. R. 839); November 15, 2010 (37:23 Md. R. 1612); November 15, 2010 (37:23 Md. R. 1612); September 19, 2011 (38:19 Md. R. 1148); August 6, 2012 (39:15 Md. R. 965); October 29, 2012 (39:21 Md., R. 1380); January 6, 2014 (40:26 Md. R. 2165); September 15, 2014 (41:18 Md. R. 1011); January 19, 2015 (42:1 Md. R. 19); June 22, 2015 (42:12 Md. R. 764); September 14, 2015 (42:18 Md. R. 1180); October 26, 2015 (42:21 Md. R. 1303); November 24, 2016 (43:23 Md. R. 1281); May 21, 2018 (45:10 Md. R. 504); February 22, 2021 (48:4 Md. R. 178); December 27, 2021 (48:26 Md. R. 1113); December 12, 2022 (49:12 Md. R. 1052)​; August 7, 2023 (50:15 Md. R. 683); August 19, 2024 (51:16 Md. R. 744); September 15, 2025 (52:18 Md. R. 924)</annotation>
    </annotations>
  </chapter>
  <chapter num="02" heading="Inspection and Certification">
    <regulation prefix="Regulation" num=".01" heading="Definitions.">
      <paragraph num="A.">
        <text>In this chapter, the following terms have the meanings indicated.</text>
      </paragraph>
      <paragraph num="B.">
        <text>Terms Defined.</text>
        <paragraph num="(1)">
          <text>“Applied radiation machine experience” means employment at activities that:</text>
          <paragraph num="(a)">
            <text>Involve the operation, maintenance, or quality control of radiation machines; and</text>
          </paragraph>
          <paragraph num="(b)">
            <text>Produce data that can be used in the determination of radiation machine compliance with the regulations of Maryland, the Federal Government, or any other state.</text>
          </paragraph>
        </paragraph>
        <paragraph num="(2)">
          <text>“Device” means any assemblage of components of a radiation machine that includes:</text>
          <paragraph num="(a)">
            <text>Not more than one control panel;</text>
          </paragraph>
          <paragraph num="(b)">
            <text>The necessary supporting structures; and</text>
          </paragraph>
          <paragraph num="(c)">
            <text>Any additional components or auxiliary equipment that function with the assemblage to produce the result desired by using the machine.</text>
          </paragraph>
        </paragraph>
        <paragraph num="(3)">
          <text>“Inspect” means the process of observing the use and operation of a radiation machine for the purpose of judging whether its use may violate a provision of the Maryland Radiation Act or any regulations issued under this Act.</text>
        </paragraph>
        <paragraph num="(4)">
          <text>“Inspector” means a person who has a valid and current license, issued by the Department pursuant to Regulation .03 of this chapter, to inspect radiation machines and radiation machine facilities.</text>
        </paragraph>
        <paragraph num="(5)">
          <text>“Major component” means a part of a radiation machine that if improperly installed, maintained, or operating could result in a higher radiation dose to humans than would occur if the component were properly installed, maintained, or operating.</text>
        </paragraph>
        <paragraph num="(6)">
          <text>“Medical physicist” means a person who has a valid and current license, issued by the Department pursuant to Regulation .03 of this chapter, to evaluate performance of mammography equipment and facility quality assurance programs.</text>
        </paragraph>
        <paragraph num="(7)">
          <text>“Radiation” means:</text>
          <paragraph num="(a)">
            <text>Ionizing radiation, including gamma rays, X-rays, alpha particles, beta particles, neutrons, high speed electrons, high speed protons, and any other atomic or nuclear particles or rays;</text>
          </paragraph>
          <paragraph num="(b)">
            <text>All electromagnetic radiation that can be generated during the operation of a manufactured device that has an electronic circuit; or</text>
          </paragraph>
          <paragraph num="(c)">
            <text>All sonic, ultrasonic, or infrasonic waves that are emitted as a result of the operation, in a manufactured device, of an electronic circuit that can generate a physical field of radiation.</text>
          </paragraph>
        </paragraph>
        <paragraph num="(8)">
          <text>“Radiation machine” means a device that is capable of producing radiation.</text>
        </paragraph>
        <paragraph num="(9)">
          <text>“State certification” or “State-certified” means a declaration by the Department that the use of a radiation machine complies with the Maryland Radiation Act and all regulations adopted under this Act.</text>
        </paragraph>
        <paragraph num="(10)">
          <text>“Reference inspection procedure” means an inspection procedure that:</text>
          <paragraph num="(a)">
            <text>Is used by the Department to determine compliance of a radiation machine with a provision of the Maryland Radiation Act or any regulations issued under this Act; and</text>
          </paragraph>
          <paragraph num="(b)">
            <text>Has been described in the “Maryland State Catalog of Reference Inspection Procedures for Inspecting Radiation Machines” (April 15, 1986) which is incorporated by reference.</text>
          </paragraph>
        </paragraph>
      </paragraph>
    </regulation>
    <regulation prefix="Regulation" num=".02" heading="State Certification of Radiation Machines.">
      <paragraph num="A.">
        <text>Applicability. This regulation does not apply to persons using the following radiation machines:</text>
        <paragraph num="(1)">
          <text>Those used for dental diagnosis or screening (machines classified in Group 6);</text>
        </paragraph>
        <paragraph num="(2)">
          <text>Those used for veterinary diagnosis or screening (machines classified in Group 7);</text>
        </paragraph>
        <paragraph num="(3)">
          <text>Those used for mammography diagnostic or screening purposes located in a mammography facility regulated under 21 CFR Part 900 (machines classified in Group 8);</text>
        </paragraph>
        <paragraph num="(4)">
          <text>Those used for veterinary dental diagnosis or screening (machines classified in Group 9);</text>
        </paragraph>
        <paragraph num="(5)">
          <text>Radiation machines exempted from the requirements of Section B.3 of the Regulations for the Control of Ionizing Radiation 1994, which is incorporated by reference in COMAR 26.12.01.01; and</text>
        </paragraph>
        <paragraph num="(6)">
          <text>Radiation machines that are licensed by the Department as provided by Section C. of the incorporated document in COMAR 26.12.01.01.</text>
        </paragraph>
      </paragraph>
      <paragraph num="B.">
        <text>Classification of Radiation Machines. Radiation machines are classified according to the following system:</text>
        <paragraph num="(1)">
          <text>Group 1 — Radiation machines that can generate radiation levels of 500 rems in one hour at one meter from the source of radiation and are used to irradiate materials. These are the radiation machines subject to  Section D.602 of the incorporated document in COMAR 26.12.01.01.</text>
        </paragraph>
        <paragraph num="(2)">
          <text>Group 2 — Radiation machines that are used for human medical therapy. These are the radiation machines subject to  Sections F.8 and F.9 of the incorporated document in COMAR 26.12.01.01.</text>
        </paragraph>
        <paragraph num="(3)">
          <text>Group 3 — Radiation machines other than those in Group 2 that are used for healing arts purposes in hospitals certified by the Joint Commission on Accreditation of Hospitals.</text>
        </paragraph>
        <paragraph num="(4)">
          <text>Group 4 — Radiation machines that are not included in Group 3 or Group 5 but their use is prescribed by a physician, chiropractor, or podiatrist.</text>
        </paragraph>
        <paragraph num="(5)">
          <text>Group 5 — Radiation machines that are not included in Groups 1 through 4 but are used:</text>
          <paragraph num="(a)">
            <text>In industrial applications;</text>
          </paragraph>
          <paragraph num="(b)">
            <text>For research purposes;</text>
          </paragraph>
          <paragraph num="(c)">
            <text>For security fluoroscopy of baggage or parcels; or</text>
          </paragraph>
          <paragraph num="(d)">
            <text>Solely for educational purposes.</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="C.">
        <text>State Certification Required for Radiation Machines.</text>
        <paragraph num="(1)">
          <text>Exemptions from Other Regulations Not Implied. A person is not exempted from complying with an applicable provision of the incorporated document in COMAR 26.12.01.01 because of compliance with this regulation.</text>
        </paragraph>
        <paragraph num="(2)">
          <text>General State Certification. Other than during inspections for compliance with these regulations, a person may not cause or permit the use of any radiation machine after the State certification due date specified for that machine in §C(5) of this regulation if it has not been State certified by the Department.</text>
        </paragraph>
        <paragraph num="(3)">
          <text>Recertification After Replacement or Rebuilding of Major Components. Except for routine X-ray tube replacement, a person may not cause or permit the use of any radiation machine that has had any major component replaced or substantially rebuilt until the major component that has been affected has been reinspected and the radiation machine has again been State certified.</text>
        </paragraph>
        <paragraph num="(4)">
          <text>Interim State Certification.</text>
          <paragraph num="(a)">
            <text>The following classes of radiation machines are State certified until the time the Department promulgates regulations controlling the use of these radiation machines:</text>
            <paragraph num="(i)">
              <text>Radiation machines that produce non-ionizing electromagnetic radiation; and</text>
            </paragraph>
            <paragraph num="(ii)">
              <text>Radiation machines that produce sonic, ultrasonic, or infrasonic radiation.</text>
            </paragraph>
          </paragraph>
          <paragraph num="(b)">
            <text>A radiation machine shall be considered State-certified by the Department until the first State certification due date established in §C(5) of this regulation, if:</text>
            <paragraph num="(i)">
              <text>The machine has been registered by the Department under Sections B. and F. of the Regulations for the Control of Ionizing Radiation (1994), which is incorporated by reference in COMAR 26.12.01.01; or</text>
            </paragraph>
            <paragraph num="(ii)">
              <text>The person responsible for the use of the machine has not been notified by the Department that the machine does not meet a provision of this subtitle.</text>
            </paragraph>
          </paragraph>
        </paragraph>
        <paragraph num="(5)">
          <text>Due Dates for State Certification. Due dates for State certification of radiation machines are established according to the Group as set forth in §B of this regulation. These dates are as follows:</text>
        </paragraph>
        <aftertext>1 “All” means all facilities of that group regardless of registration number. The certification due date for Group 1 machines shall be July 1st of each year. The certification due date for Group 2 machines shall be December 31st of each year.</aftertext>
      </paragraph>
      <paragraph num="D.">
        <text>Application for State Certification.</text>
        <paragraph num="(1)">
          <text>Each person responsible for the use of a radiation machine shall apply for State certification of the machine at least 45 days, but not more than 180 days, before the scheduled due date established in §C(5) of this regulation.</text>
        </paragraph>
        <paragraph num="(2)">
          <text>The application shall be made on forms issued by the Department and shall contain:</text>
          <paragraph num="(a)">
            <text>All information indicated on the forms; and</text>
          </paragraph>
          <paragraph num="(b)">
            <text>A Departmental inspection report that has been completed and signed by an inspector licensed under Regulation .03 of this chapter.</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="E.">
        <text>Denial of Certification.</text>
        <paragraph num="(1)">
          <text>The Department shall deny State certification of a radiation machine if it determines that the use of the machine will result in a violation of either the Maryland Radiation Act or any regulation promulgated under this Act.</text>
        </paragraph>
        <paragraph num="(2)">
          <text>A determination made by the Department under §E(1) may be made based on information contained on the inspection report, an independent inspection made by the Department, or any other pertinent information known by the Department.</text>
        </paragraph>
      </paragraph>
    </regulation>
    <regulation prefix="Regulation" num=".03" heading="Licensing of Inspectors.">
      <paragraph num="A.">
        <text>Application For a License. A person may apply to the Department, on forms provided by the Department, for a license to inspect radiation machines or for the renewal or reinstatement of a previously issued license. The application shall contain all information indicated on the form.</text>
      </paragraph>
      <paragraph num="B.">
        <text>Denial of Application.</text>
        <paragraph num="(1)">
          <text>The Department shall deny an application for a license to inspect radiation machines if the applicant:</text>
          <paragraph num="(a)">
            <text>Has not demonstrated compliance with the State Workers' Compensation Laws as required by Environment Article, §1-202, Annotated Code of Maryland; or</text>
          </paragraph>
          <paragraph num="(b)">
            <text>Has a financial arrangement with any business entity offering commercial sales or servicing of radiation machines.</text>
          </paragraph>
        </paragraph>
        <paragraph num="(2)">
          <text>The Department may deny an application, or suspend or revoke a license, or grant a license with conditions, if it determines that the applicant or licensee does not have sufficient training or applied radiation machine experience to carry out the requirements of this regulation, has demonstrated improper performance in the inspection of radiation machines as provided under §C of this regulation, or has not performed any State certifications during a licensing period.</text>
        </paragraph>
        <paragraph num="(3)">
          <text>Determination Criteria. The determination made by the Department under §B(2) of this chapter shall be made using the following criteria:</text>
          <paragraph num="(a)">
            <text>The licensee shall have a level of training and applied radiation machine experience equal to or greater than one of the following sets of criteria:</text>
            <paragraph num="(i)">
              <text>A bachelor's degree with 30 credit hours in the physical or biological sciences or mathematics, and 4 years of applied radiation machine experience acceptable to the Department;</text>
            </paragraph>
            <paragraph num="(ii)">
              <text>A master's degree in health physics or medical radiological physics, and 2 years of applied radiation machine experience acceptable to the Department;</text>
            </paragraph>
            <paragraph num="(iii)">
              <text>A doctor's degree in health physics or medical radiological physics, and 1 year of applied radiation machine experience acceptable to the Department;</text>
            </paragraph>
            <paragraph num="(iv)">
              <text>Certification by the American Board of Health Physics or the American Board of Radiology, and 1 year of applied radiation machine experience acceptable to the Department; or</text>
            </paragraph>
            <paragraph num="(v)">
              <text>An associate's degree with 15 credit hours in the physical or biological sciences or mathematics, and 10 years of applied radiation experience acceptable to the Department;</text>
            </paragraph>
          </paragraph>
          <paragraph num="(b)">
            <text>In addition to the requirements of §B(3)(a) of this regulation, a licensee who inspects radiation machines having energy levels greater than one million electron volts shall have at least 1 year of experience at activities that provide information useful in the determination of compliance of these radiation machines with Section F.(9) and I. of the Regulations for the Control of Ionizing Radiation (1994), which is incorporated by reference in COMAR 26.12.01.01 or the equivalent regulations of the federal government or of any other state.</text>
          </paragraph>
          <paragraph num="(c)">
            <text>In addition to the requirements of §B(3)(a) or B(3)(b) of this regulation, a licensee who evaluates the performance of mammography equipment and facility quality assurance programs shall meet all qualifications for a medical physicist set forth in 21 CFR §900.12(a)(3).</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="C.">
        <text>Suspension or Revocation of License.  The Department may deny a renewal application or suspend or revoke a license if it determines that the inspector:</text>
        <paragraph num="(1)">
          <text>Has a financial arrangement with any business entity offering commercial sales or servicing of radiation machines;</text>
        </paragraph>
        <paragraph num="(2)">
          <text>Has falsified data on a report;</text>
        </paragraph>
        <paragraph num="(3)">
          <text>Has used an inspection procedure found unacceptable under Regulation .05C;</text>
        </paragraph>
        <paragraph num="(4)">
          <text>Is negligent in the performance of inspections such that significant errors result;</text>
        </paragraph>
        <paragraph num="(5)">
          <text>Has performed an inspection for the purpose of State certification without having filed a report with the Department within 30 days of the inspection;</text>
        </paragraph>
        <paragraph num="(6)">
          <text>Has violated any other applicable regulation in this chapter; or</text>
        </paragraph>
        <paragraph num="(7)">
          <text>Has failed to provide, in the initial or renewal application for a medical physicist, documentation of information, such as continuing education.</text>
        </paragraph>
      </paragraph>
      <paragraph num="D.">
        <text>Duration of Licenses. Unless a license is suspended or revoked as provided in §C of this regulation or has been issued with conditions, a license shall remain in effect for 3 years from the date of issuance.</text>
      </paragraph>
      <paragraph num="E.">
        <text>License To Be Available.</text>
        <paragraph num="(1)">
          <text>An inspector shall maintain the license or a copy of the license in his possession and shall show the license to every person for whom an inspection is to be performed before the inspection.</text>
        </paragraph>
        <paragraph num="(2)">
          <text>The inspector shall make the license immediately available to the Department upon request.</text>
        </paragraph>
      </paragraph>
    </regulation>
    <regulation prefix="Regulation" num=".04" heading="Notification and Hearings.">
      <paragraph num="A.">
        <text>Notification of Denial, Suspension, or Revocation; Hearing. An order denying, suspending, or revoking a license or certificate, or the granting of a license or certificate with conditions, shall be personally served as summonses are served, or by certified mail, upon the applicant or licensee and shall be final unless the applicant or licensee requests a hearing before the Department within 10 days after service.</text>
      </paragraph>
      <paragraph num="B.">
        <text>When a hearing is requested by the applicant or licensee, under §A of this regulation, it shall be held pursuant to the Administrative Procedure Act, State Government Article, §§10-201—10-226, Annotated Code of Maryland.</text>
      </paragraph>
    </regulation>
    <regulation prefix="Regulation" num=".05" heading="Inspection Procedures.">
      <paragraph num="A.">
        <text>Procedures Common To All Radiation Machine Inspections. The inspector shall:</text>
        <paragraph num="(1)">
          <text>Notify the Department's Radiological Health Program immediately by telephone if a situation is discovered where a person could receive an excess radiation dose due to a radiation machine not meeting the requirements of Sections A., B., E., F., H., I., or J. of the Regulations for the Control of Ionizing Radiation (1994), which is incorporated by reference in COMAR 26.12.01.01 and if that dose may cause an imminent and substantial endangerment to health;</text>
        </paragraph>
        <paragraph num="(2)">
          <text>Record all information required by the State Certification Data Forms;</text>
        </paragraph>
        <paragraph num="(3)">
          <text>Observe if the notices to workers are posted as required by Section J. of the incorporated document in COMAR 26.12.01.01;</text>
        </paragraph>
        <paragraph num="(4)">
          <text>Observe if the warning signs and instructions of Sections D. and F. of the incorporated document in COMAR 26.12.01.01 are posted when required;</text>
        </paragraph>
        <paragraph num="(5)">
          <text>Determine the adequacy of the personnel monitoring system if a system is required by Section D.202 of the incorporated document in COMAR 26.12.01.01;</text>
        </paragraph>
        <paragraph num="(6)">
          <text>Forward a copy of the inspection report to the Department not later than 30 calendar days after the beginning of each radiation machine inspection; and</text>
        </paragraph>
        <paragraph num="(7)">
          <text>Record the nature of any machine adjustments or repairs that are carried out during the time of the inspection on the appropriate spaces provided on the Department inspection report forms.</text>
        </paragraph>
      </paragraph>
      <paragraph num="B.">
        <text>Inspections Performed According to Procedures.</text>
        <paragraph num="(1)">
          <text>While inspecting a radiation machine, an inspector shall use a procedure that is adequate to determine compliance with the requirement of this subtitle.</text>
        </paragraph>
        <paragraph num="(2)">
          <text>An inspector may not use an inspection test procedure that has been found by the Department to be an unacceptable test procedure under §C of this regulation.</text>
        </paragraph>
        <paragraph num="(3)">
          <text>The Department will periodically audit the performance of inspectors, including verification that at least one State certification was performed during the licensing period.</text>
        </paragraph>
      </paragraph>
      <paragraph num="C.">
        <text>Finding of Unacceptability of Test Procedure.</text>
        <paragraph num="(1)">
          <text>Upon request by the Department, an inspector shall provide a schedule of forthcoming inspections of radiation machines.</text>
        </paragraph>
        <paragraph num="(2)">
          <text>An inspector shall cooperate with any agent of the Department while the agent is auditing the performance of a radiation machine inspection.</text>
        </paragraph>
        <paragraph num="(3)">
          <text>Initial Finding.</text>
          <paragraph num="(a)">
            <text>Based upon audit information, inspection report information or any other pertinent information known to the Department, the Department may notify an inspector that a procedure or part of a procedure used under §B is questionable and shall provide the reasons for this finding.</text>
          </paragraph>
          <paragraph num="(b)">
            <text>Not later than 20 calendar days following receipt of the notification under §C(3)(a), of this regulation, the inspector shall forward to the Department a detailed, written description of the questionable inspection procedure.</text>
          </paragraph>
          <paragraph num="(c)">
            <text>If an inspector does not meet the requirement of §C(3)(b), of this regulation, a finding that a procedure is questionable under §C(3)(a), of this regulation, shall become a finding of unacceptability for the purpose of §B of this regulation.</text>
          </paragraph>
          <paragraph num="(d)">
            <text>Based upon the information received under §C(3)(a) and (b), of this regulation, the Department shall notify the inspector within 25 calendar days following the forwarding of the written description under §C(3)(b), of this regulation, that the questionable inspection procedure is found to be:</text>
            <paragraph num="(i)">
              <text>Acceptable; or</text>
            </paragraph>
            <paragraph num="(ii)">
              <text>Initially unacceptable.</text>
            </paragraph>
          </paragraph>
        </paragraph>
        <paragraph num="(4)">
          <text>Final Finding.</text>
          <paragraph num="(a)">
            <text>If an initially unacceptable finding is made under §C(3)(d)(ii), the inspector may request that a final finding be made under this regulation.</text>
          </paragraph>
          <paragraph num="(b)">
            <text>A finding that a procedure is initially unacceptable shall become a final finding of unacceptability for the purpose of §B, of this regulation, if the inspector does not request a final finding within 14 calendar days following the inspector's receipt of notification under §C(3)(d) of this regulation.</text>
          </paragraph>
          <paragraph num="(c)">
            <text>Not later than 60 calendar days following the Department's receipt of the request for a final finding under §C(4)(a), of this regulation, the inspector shall conduct a personal demonstration for the Department of the inspection procedure in question. The personal demonstration may include:</text>
            <paragraph num="(i)">
              <text>A physical demonstration of the procedure using the type of radiation machine that it was designed to inspect;</text>
            </paragraph>
            <paragraph num="(ii)">
              <text>A mathematical demonstration of the theory upon which the procedure is based; or</text>
            </paragraph>
            <paragraph num="(iii)">
              <text>Any other method of demonstration agreed to by the Department.</text>
            </paragraph>
          </paragraph>
          <paragraph num="(d)">
            <text>A demonstration arranged by the inspector under §C(4)(c) of this regulation shall be made:</text>
            <paragraph num="(i)">
              <text>At a time and location convenient to the Department;</text>
            </paragraph>
            <paragraph num="(ii)">
              <text>At a reasonable expense to the Department; and</text>
            </paragraph>
            <paragraph num="(iii)">
              <text>According to a demonstration protocol prepared by the inspector and approved by the Department.</text>
            </paragraph>
          </paragraph>
          <paragraph num="(e)">
            <text>In making its final finding, the Department will determine whether the inspector has presented sufficient additional information that will allow the Department to change the initially unacceptable finding to an acceptable finding.</text>
          </paragraph>
        </paragraph>
        <paragraph num="(5)">
          <text>In making its initial or final finding, the Department will determine whether the inspector has demonstrated, to the satisfaction of the Department, that the questionable inspection procedure can produce data that is as accurate and precise as the applicable reference inspection procedure.</text>
        </paragraph>
      </paragraph>
      <paragraph num="D.">
        <text>Use of Unlicensed Personnel.</text>
        <paragraph num="(1)">
          <text>Other than as provided in §C(2) of this regulation, the use of unlicensed persons in the conduct of a certification inspection is not allowed.</text>
        </paragraph>
        <paragraph num="(2)">
          <text>An inspector may use an unlicensed assistant or trainee during the course of an inspection if the assistant or trainee is under the personal supervision of the licensee at all times. “Personal supervision” means guidance and instruction provided to an assistant or trainee by an inspector licensed under this chapter who is present at the site, in visual contact with the assistant or trainee while the assistant or trainee is using sources of radiation, and in such proximity that immediate advice or assistance can be given.</text>
        </paragraph>
      </paragraph>
    </regulation>
    <annotations>
      <annotation type="Authority">Environment Article, §§8-104(a), 8-106, 8-301, 8-304, and 8-306, Annotated Code of Maryland</annotation>
      <annotation type="History" subtype="Administrative History">Effective date:</annotation>
      <annotation type="History" subtype="Administrative History">Regulations .02—.06 adopted April 30, 1987 (14:4 Md. R. 418)</annotation>
      <annotation type="History" subtype="Administrative History">COMAR 10.14.02.02—.06 recodified to COMAR 26.12.02.01—.05</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 29, 2004 (31:6 Md. R. 510)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 29, 2004 (31:6 Md. R. 510)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02A amended effective May 21, 2018 (45:10 Md. R. 504)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 20, 1997 (24:21 Md. R. 1453)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02C amended effective February 15, 1993 (20:3 Md. R. 261); October 20, 1997 (24:21 Md. R. 1453); November 15, 2010 (37:23 Md. R. 1613); February 22, 2021 (48:4 Md. R. 178)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02D amended effective May 14, 1990 (17:9 Md. R. 1092)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 29, 2004 (31:6 Md. R. 510)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .03B, C amended effective January 19, 2015 (42:1 Md. R. 19)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .04B amended effective March 29, 2004 (31:6 Md. R. 510)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .05A, B amended effective March 29, 2004 (31:6 Md. R. 510)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .05D adopted effective October 20, 1997 (24:21 Md. R. 1453)</annotation>
    </annotations>
  </chapter>
  <chapter num="03" heading="State Radiation Control Fund">
    <regulation prefix="Regulation" num=".01" heading="Definitions.">
      <paragraph num="A.">
        <text>In this chapter, the following terms have the meanings indicated.</text>
      </paragraph>
      <paragraph num="B.">
        <text>Terms Defined.</text>
        <paragraph num="(1)">
          <text>“Calendar year 2011 base” or “CY 2011 base” means the base year fee from calendar year 2011. The base year fee is adjusted annually in accordance with the Consumer Price Index as provided in Regulation .04 of this chapter.</text>
        </paragraph>
        <paragraph num="(2)">
          <text>“Facility” means the location at which one or more sources of radiation are:</text>
          <paragraph num="(a)">
            <text>Installed or located within one building, vehicle, or under one roof; and</text>
          </paragraph>
          <paragraph num="(b)">
            <text>Under the same administrative control.</text>
          </paragraph>
        </paragraph>
        <paragraph num="(3)">
          <text>“Group” means the classification of radiation machine established by COMAR 26.12.02.02B.</text>
        </paragraph>
        <paragraph num="(4)">
          <text>“Irradiator license” means a category of specific license authorizing a person to possess and use radioactive material to perform intentional exposure of various products to ionizing radiation to effect polymerization, sterilization, or other effects.</text>
        </paragraph>
        <paragraph num="(5)">
          <text>“Radiation machine” means a device that is capable of producing radiation. On any radiation producing equipment having at least one X-ray tube, or other single point from which radiation may be emitted, each X-ray tube or other radiation emission point is considered a separate radiation machine for purposes of this section.</text>
        </paragraph>
        <paragraph num="(6)">
          <text>“Sealed source and device registration” means the administrative process by which Maryland companies who intend to manufacture or distribute a sealed radioactive source or device containing a radioactive sealed source under a specific or general license obtain the Department's approval of a document containing the radiation safety and engineering evaluation of the product information.</text>
        </paragraph>
        <paragraph num="(7)">
          <text>“Teletherapy license” means a category of specific license authorizing a person to possess or use radioactive materials to administer teletherapy as defined in §A.2 of the Regulations for the Control of Ionizing Radiation (1994), which is incorporated by reference in COMAR 26.12.01.01.</text>
        </paragraph>
        <paragraph num="(8)">
          <text>“Unregistered facility” means a facility at which one or more radiation machines is installed without the facility having been registered with the Department, in violation of the provisions of §B.5 of the Regulations for the Control of Ionizing Radiation (1994), which is incorporated by reference in COMAR 26.12.01.01.</text>
        </paragraph>
        <paragraph num="(9)">
          <text>“X-ray tube” means any electron tube that is designed to be used primarily for the production of X-rays. For the purpose of this regulation, a tube means an X-ray tube, unless otherwise specified.</text>
        </paragraph>
      </paragraph>
    </regulation>
    <regulation prefix="Regulation" num=".02" heading="Fee Required.">
      <paragraph num="A.">
        <text>Exemptions. This regulation does not apply to persons using the following sources of radiation:</text>
        <paragraph num="(1)">
          <text>Radiation machines exempted from registration by the Department according to §B.3 of Regulations for the Control of Ionizing Radiation (1994), which is incorporated by reference in COMAR 26.12.01.01;</text>
        </paragraph>
        <paragraph num="(2)">
          <text>Radioactive materials that are not subject to licensing by Part C of Regulations for the Control of Ionizing Radiation (1994), which is incorporated by reference in COMAR 26.12.01.01;</text>
        </paragraph>
        <paragraph num="(3)">
          <text>Radiation machines located at a school of dentistry accredited by the Commission on Dental Accreditation of the American Dental Association; and</text>
        </paragraph>
        <paragraph num="(4)">
          <text>Temporary dental clinics that:</text>
          <paragraph num="(a)">
            <text>Hold a permit under Health Occupations Article, Title 4, Annotated Code of Maryland;</text>
          </paragraph>
          <paragraph num="(b)">
            <text>Provide all services on a pro bono basis; and</text>
          </paragraph>
          <paragraph num="(c)">
            <text>Operate fewer than 100 hours per year.</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="B.">
        <text>The Agency may, upon application or upon its own initiative, grant other exemptions or exceptions from the requirements of this chapter that it determines are authorized by law.</text>
      </paragraph>
      <paragraph num="C.">
        <text>Past Due Fees for Unregistered Facilities. A person submitting an application for registration of a radiation machine or machines in an unregistered facility shall remit a past due fee for each machine at the facility for each year the facility was in operation without having been registered in accordance with §B.5 of Regulations for the Control of Ionizing Radiation (1994). The fee is based on the schedule in Regulation .03A of this chapter.</text>
      </paragraph>
      <paragraph num="D.">
        <text>Biennial Fees for Radiation Machine Facilities. Except for dental facilities, which must pay annually, each radiation machine facility shall pay to the Department a biennial fee for each radiation machine in that facility based on the fee schedule in Regulation .03B of this chapter. The fee shall be paid on or before the first day of the month in which the anniversary of the registration date occurs. The Department shall collect the biennial fee in two equal annual installments.</text>
      </paragraph>
      <paragraph num="E.">
        <text>Annual Fees for Licenses to Possess or Use Radioactive Materials. A person with a license to possess or use radioactive material shall pay to the Department an annual licensing fee in accordance with the fee schedule set forth in Regulation .03C of this chapter. The fee shall be paid on or before the first day of the month in which the anniversary of the license date occurs.</text>
      </paragraph>
      <paragraph num="F.">
        <text>Radioactive Material License Reciprocity Fee. A person granted a general license to conduct an activity under the authority of §C.90 of Regulations for the Control of Ionizing Radiation (1994) shall remit a fee equal to the amount shown in Regulation .03C of this chapter. The fee shall be received by the Department before the person may conduct any activity covered by the license during the 180-day period in which the general license is effective.</text>
      </paragraph>
      <paragraph num="G.">
        <text>All fees shall be:</text>
        <paragraph num="(1)">
          <text>Payable to the Maryland Department of the Environment Radiation Control Fund;</text>
        </paragraph>
        <paragraph num="(2)">
          <text>Accompanied by required documents provided by the Department; and</text>
        </paragraph>
        <paragraph num="(3)">
          <text>Applied to the year following the date payment of the fee is due.</text>
        </paragraph>
      </paragraph>
      <paragraph num="H.">
        <text>Dental Radiation Machine Fees.</text>
        <paragraph num="(1)">
          <text>The annual fee for dental radiation machines shall be $60 per tube, as shown in Regulation .03, Table 2, beginning July 1, 2002.</text>
        </paragraph>
        <paragraph num="(2)">
          <text>The annual fee for dental radiation machines shall be $70 per tube beginning June 30, 2004.</text>
        </paragraph>
        <paragraph num="(3)">
          <text>The annual fee for dental radiation machines shall be $80 per tube during the period from July 1, 2006 through June 30, 2010. The annual fee for dental radiation machines shall remain at $80 per tube after June 30, 2010, unless altered by the General Assembly.</text>
        </paragraph>
      </paragraph>
      <paragraph num="I.">
        <text>Sealed Source and Device Registration Fees.</text>
        <paragraph num="(1)">
          <text>Each holder of a Maryland-issued sealed source and device registration sheet shall pay an annual fee [of $1,600 per source or device registration sheet] in accordance with Regulation .03D of this chapter as adjusted each year in accordance with the Consumer Price Index as provided in Regulation .04 of this chapter. This fee shall be paid on or before the first day of the month of the initial issuance date of the registration sheet or sheets.</text>
        </paragraph>
        <paragraph num="(2)">
          <text>Application fees for evaluating requests for new or modified in entirety sealed source and device registration sheets shall be in accordance with Regulation .03D of this chapter as adjusted each year in accordance with the Consumer Price Index as provided in Regulation .04 of this chapter and shall be paid upon application.</text>
        </paragraph>
      </paragraph>
      <paragraph num="J.">
        <text>Annual General License Fees. Each person as defined in §A.2 of the Regulations for the Control of Ionizing Radiation who possesses radioactive material under the provisions of a general license in §C.22(a), (d), and (e) of COMAR 26.12.01.01  shall pay a calendar year 2016 base annual fee of $50 as adjusted each calendar year in accordance with the Consumer Price Index as provided in Regulation .04 of this chapter.</text>
      </paragraph>
    </regulation>
    <regulation prefix="Regulation" num=".03" heading="Fee Schedule.">
      <paragraph num="A.">
        <text>Table I — Past Due Fees for Unregistered Facilities.</text>
      </paragraph>
      <paragraph num="B.">
        <text>Table 2 — Radiation Machine Fees.</text>
      </paragraph>
      <paragraph num="C.">
        <text>Table 3 — Fees for Specific Radioactive Material Licenses and Reciprocity.</text>
      </paragraph>
      <paragraph num="D.">
        <text>Table 4—Fees for Sealed Source and Device Sheets.</text>
      </paragraph>
    </regulation>
    <regulation prefix="Regulation" num=".04" heading="Consumer Price Index Adjustment.">
      <paragraph num="A.">
        <text>Beginning January 1, 2012, the annual fees set forth in this chapter, with the exception of Group 6 dental facilities and Group 9 veterinary dental machines, shall be increased each year by the percentage, if any, by which the Consumer Price Index for the most recent calendar year exceeds the Consumer Price Index for the previous calendar year.</text>
      </paragraph>
      <paragraph num="B.">
        <text>The Consumer Price Index for a calendar year is the average of the Consumer Price Index for all urban consumers published by the Department of Labor as of the close of the 12-month period ending on August 31 of each calendar year.</text>
      </paragraph>
      <paragraph num="C.">
        <text>For radioactive materials licensees with a calendar year 2011 base fee greater than $1,000 and sealed source and device sheets, each annual fee adjustment to reflect a change in the Consumer Price Index will be rounded to the nearest higher hundred-dollar increment.  For radiation machine fees except dental fees, for general license fees, and for those radioactive material licensees with a calendar year 2011 base fee of $1,000 or less, each annual fee adjustment to reflect a change in the Consumer Price Index will be rounded to the nearest higher one-dollar increment.</text>
      </paragraph>
    </regulation>
    <annotations>
      <annotation type="Authority">Environment Article, §§8-301(b)(1)(iii), 8-301(c), 8-304(c), and 8-306, Annotated Code of Maryland</annotation>
      <annotation type="History" subtype="Administrative History">Effective date: May 14, 1990 (17:9 Md. R. 1092)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02C amended effective February 15, 1993 (20:3 Md. R. 261)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02D, E amended effective December 23, 1991 (18:25 Md. R. 2759)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02F, G amended effective July 4, 1994 (21:13 Md. R. 1160)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 4, 1994 (21:13 Md. R. 1160)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 23, 1991 (18:25 Md. R. 2759)</annotation>
      <annotation type="History" subtype="Administrative History">Regulations .01—.03 repealed and new Regulations .01—.03 adopted effective January 26, 1998 (25:2 Md. R. 81)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 29, 2004 (31:6 Md. R. 511); August 16, 2004 (31:16 Md. R. 1256); January 1, 2015 (41:17 Md. R. 971)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 29, 2004 (31:6 Md. R. 511)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02A, J amended effective August 29, 2016 (43:17 Md. R. 959)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02I, J adopted effective August 16, 2004 (31:16 Md. R. 1256)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02I amended effective March 21, 2011 (38:6 Md. R. 397)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .02I, J amended effective January 1, 2015 (41:17 Md. R. 971)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .03 amended effective August 16, 2004 (31:16 Md. R. 1256); March 21, 2011 (38:6 Md. R. 397); January 1, 2015 (41:17 Md. R. 971); August 29, 2016 (43:17 Md. R. 959)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .03A, B amended effective March 29, 2004 (31:6 Md. R. 511)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .04 adopted effective March 21, 2011 (38:6 Md. R. 397)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .04A amended effective August 29, 2016 (43:17 Md. R. 959)</annotation>
      <annotation type="History" subtype="Administrative History">Regulation .04C amended effective January 1, 2015 (41:17 Md. R. 971)</annotation>
    </annotations>
  </chapter>
</subtitle>