Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part C - LICENSING OF RADIOACTIVE MATERIAL › Appendix 144-220-C-A - GENERAL PROVISIONS

Current through 2024-29, July 17, 2024
A. Purpose.
The regulations in this Part set out fees charged for
					 licensing and registration services rendered by the Maine Center for Disease
					 Control and Prevention, Radiation Control Program (the Agency), as authorized
					 under 22 MRSA Section 680 of Maine's Radiation Protection Act.
B. Scope.
Except for persons who apply for or hold the permits,
					 licenses, or approvals exempted in Part C, the regulations in this section
					 apply to a person who is:
1. An applicant for or holder of a specific radioactive
					 material license, NARM material, source material, or special nuclear material
					 license issued pursuant to Part C of these rules;
2. An applicant for or holder of specific approval of
					 shipping containers issued pursuant to Part L of these rules;
3. An applicant for or holder of a specific approval of
					 sealed sources and devices containing radioactive material, NARM material,
					 source material, or special nuclear material;
4. Required to have routine and non-routine safety and
					 safeguards inspections of activities licensed pursuant to the requirements of
					 these rules; or
5. An applicant for or holder of a license, approval,
					 determination, or other authorization issued by the Agency pursuant to these
					 rules.
C. Definitions.
As used in this Part:
1. Materials license means a radioactive, NARM, or a source
					 material license issued pursuant to Part C of these rules.
2. Sealed source means any radioactive material, or NARM
					 material that is encased in a capsule designed to prevent leakage or escape of
					 the material.
3. Inspection means:
a. Routine inspections designed to evaluate the licensee's
					 activities within the context of the licensee having primary responsibility for
					 protection of the public and environment.
b. Non-routine inspections in response or reaction to an
					 incident, allegation, follow-up to inspection deficiencies or inspections to
					 determine implementation of safety issues. A non-routine or reactive inspection
					 has the same purpose as the routine inspection.
4. State agency means any executive department, commission,
					 independent establishment, corporation, wholly or partly owned by the State of
					 Maine, or any board, bureau, division, service, office, officer, authority,
					 administration, or other establishment in the executive branch of the
					 State.
D. Exemptions.
1. No application fees, annual fees, amendment fees, or
					 inspection fees shall be required for:
a. A license authorizing the export only of a production or
					 utilization facility.
b. A license authorizing the export only or import only of
					 radioactive material, source material or special nuclear material.
2. A license authorizing the use of source material as
					 shielding only in devices and containers, provided, however, that all other
					 licensed radioactive material, source material, or special nuclear material in
					 the device or container will be subject to the fees prescribed in Table 1 of
					 this Appendix.
E. Payment of fees
1. Application fees. Each application for which a fee is
					 prescribed shall be accompanied by a remittance in the full amount of the fee.
					 No application will be accepted for filing or processed prior to payment of the
					 full amount specified. Applications for which no remittance is received may be
					 returned to the applicant. All application fees will be charged irrespective of
					 the Agency's disposition of the application or withdrawal of the
					 application.
2. Full cost. For each application on which the review
					 charges are based on full costs and the application has been pending with the
					 Agency for six months or longer, the first bill for accumulated costs will be
					 sent and will include all of the applicable review time and contractual costs
					 expended. Thereafter, each applicant will be billed at six-month intervals or
					 when the review is completed, whichever is earlier. Each bill will identify the
					 applications and the costs related to each.
3. Non-routine inspection fees. Non-routine inspection fees
					 are payable upon notification by the Agency. Inspection costs will include
					 preparation time, time on site and documentation time and any associated
					 contractual service costs but will exclude the time involved by the staff in
					 the processing and issuance of a notice of violation or civil penalty.
4. Annual fees. A license fee based upon the type of
					 license, number of sources and/or gauges shall be assessed on an annual basis.
					 The licensee has until June 1st of the billing year or 60 days from the
					 postmark date of the radioactive materials license annual fees invoice,
					 whichever is later, to submit payment in full, unless special arrangements are
					 made with the Agency. Failure to pay the annual fee by the due date will result
					 in a penalty not to exceed 9 percent of the unpaid fee compounded monthly.
					 Failure to remit full payment within six months could, at the Agency's
					 discretion, result in the initiation of license termination procedures.
5. Method of payment. Fee payments shall be by check,
					 draft, or money order made payable to the Treasurer, State of Maine.
F. Average cost per professional staff-hour.
Fees for permits, licenses, amendments, renewals, special projects and
					 inspections will be calculated based upon the full costs for the review.
TABLE 1 to Appendix A
RADIOACTIVE MATERIALS SPECIFIC LICENSE AND INSPECTION
					 FEE SCHEDULE
LICENSE CATEGORY
APPLICATION
ANNUAL
NON-ROUTINE
								INSPECTION
1. SPECIAL NUCLEAR MATERIAL
A. Sealed sources in devices
$500.00
$1200.005
$1,300.00
B. Pacemakers
$500.00
$350.00
$800.00
C. Other except critical
$690.00
$3,800.00
$800.00
D. Termination
$500.00
2. SOURCE MATERIAL
A. Shielding
$110.00
$450.00
$350.00
B. Water treatment wastes
$800.00
$1,100.00
$1,300.00
C. Other
$790.00
$8,100.00
$1,500.00
D. Termination
$500.00
Full Cost
3. RADIOACTIVE MATERIAL, NATURALLY OCCURRING
								RADIOACTIVE MATERIAL OR ACCELERATOR PRODUCED MATERIAL
A. Processing or manufacturing for commercial
								distribution
1. Broad Scope A
$8,000.00
$20,000.00
$2,100.00
2. Broad Scope B
$7,000.00
$15,000.00
$2,100.00
3. Broad Scope C
$6,000.00
$12,000.00
$2,100.00
4. Other
$1,300.00
$4,875.00
$2,000.00
B. Radiopharmaceuticals, reagent kits, sources and
								devices
1. Processing, manufacturing and distribution. This
								category includes nuclear pharmacies.
$6,000.00
$6,750.00
$1,900.00
2. Cyclotron for processing, manufacturing and
								distribution.
$6,500.00
$6,100.00
$1,900.00
3. Distribution only
$2,000.00
$4350.00
$1,200.00
C. Sealed sources for irradiation
1. Fixed, self shielded
$1,500.00
$2,325.00
$690.00
2. Exposed source < 10,000 Ci.
$3,000.00
$6,350.00
$1,300.00
3. Exposed source > 10,000 Ci.
$8,000.00
$31,400.00
$1,400.00
D. Distribution to persons exempt (NARM)
1. Device review required
$2,500.00
$6,600.00
$690.00
2. No device review required
$3,000.00
$7,450.00
$690.00
E. Distribution to persons generally
								licensed
1. SSD review required
$2,500.00
$3,300.00
$690.00
2. No SSD review required
$1,900.00
$1,250.00
$690.00
F. Research and development, no commercial
								distribution
1. Broad Scope A
$3,300.00
$8,500.00
$1,200.00
2. Broad Scope B
$2,500.00
$7,000.00
$1,200.00
3. Broad Scope C
$2,300.00
$5,500.00
$1,200.00
4. Other
$1,500.00
$3,250.00
$930.00
G. Services for other licensees
$2,000.00
$3,400.00
$690.00
H. Industrial radiography
$4,000.00
$8,400.00
$2,500.00
I. All other radioactive and NARM, except 4A
								through 8D
1. Portable gauges
$700.00
$1,000.005
$1,200.00
2. Fixed gauges
$700.00
$1,000.005
$1,200.00
3. X-ray fluorescence
$700.00
$1,000.005
$1,200.00
4. Laboratory services
$700.00
$1,000.00
$1,200.00
5. Storage only
$500.00
$800.00
$1,200.00
6. In-vitro laboratories
$500.00
$1,000.00
$1,200.00
7. Gas chromatographs
$500.00
$800.00
$1,200.00
8. Other
$500.00
$1,100.00
$1,200.00
4. WASTE DISPOSAL SERVICES
A. Packaging or repackaging
$2,800.00
$7,000.00
$1,600.00
B. Transfer to another person
$2,500.00
$5,000.00
$2,100.00
C. Incineration or other treatment
$500 + full cost
$14,100.00
5. WELL LOGGING
A. Well logging and tracer studies
$3,400.00
$4,850.00
$800.00
B. Field flooding tracer studies
$500.00 + full cost
$5,000.00
$1,200.00
6. NUCLEAR LAUNDRIES
$8,000.00
$17,700.00
$1,900.00
7. MEDICAL (HUMAN) USE
A. Broad scope
$5,000.00
$17,250.00
$1,800.00
B. Other Medical Use
1. G.100 - Use of unsealed radioactive material for
								uptake, dilution, and excretion studies-written directive not required
$1,000.00
$2,500.00
$1,500.00
2. G.200 - Use of unsealed radioactive material for
								imaging and localization studies-written directive not required
$1,000.00
$2,500.006
$1,500.00
3. G.300 - Use of unsealed radioactive material -
								written directive required
$1,000.00
$2,500.006
$1,500.00
4. G.400 - Manual brachytherapy
$1,000.00
$2,500.006
$1,500.00
5. G.500 - Sealed sources for diagnosis
$1,000.00
$2,500.006
$1,500.00
6. G.600 - Sealed source(s) in a device for
								therapy-teletherapy, remote afterloader, or gamma stereotactic radiosurgery
								unit
$3,400.00
$8,500.006
$1,900.00
7. G.1000 - Other medical uses of RAM or radiation
								from RAM
$2,000.00
$4,500.006
$1,900.00
8. CIVIL DEFENSE ACTIVITIES
$580.00
$1,275.00
$690.00
9. DEVICE, PRODUCT OR SEALED SOURCE SAFETY
								EVALUATION
A. Devices, for commercial dist.
$4,000.00
$10,400.00
B. Devices, single applicant
$4,000.00
$10,400.00
C. Sources, for commercial dist.
$2,500.00
$7,300.00
D. Sources, single applicant
$750.00
$1,200.00
10. GENERAL LICENSE
								REGISTRATION
A. Submission of form HHE-860
$200.00
$1,200.00
B. Submission of form HHE-861 (facility)
$200.00
$1,200.00
C. Submission of form HHE-862 (device)
$200.00
$1,200.00
D. Submission of form HHE-863 (facility)
$200.00
$1,200.00
E. Submission of form HHE-867
$200.00
$1,200.00
11. RECIPROCITY
$1,800.00
TABLE 1 to Appendix A
1. Types of material license fees - Separate charges as
					 shown in the schedule will be assessed for applications for new licenses and
					 approvals, issuance of new licenses and approvals, and amendments to existing
					 licenses and approvals. The following guidelines apply to these charges:
a. Application fees - Applications for materials licenses
					 and approvals must be accompanied by the prescribed application fee for each
					 category, except that applications for licenses covering more than one fee
					 category of special nuclear material or source material to be used at the same
					 location, must be accompanied by the prescribed application fee for the highest
					 fee category. When a license or approval has expired, the application fee for
					 each category shall be due, except for licenses covering more than one fee
					 category of special nuclear material or source material for use at the same
					 location, in which case the application fee for the highest category
					 applies.
b. License/approval fees - For new licenses and approvals
					 issued in fee Categories 1D, 2C, 4C, and 5B, the recipient shall pay the
					 license or approval fee for each category, as determined by the Agency in
					 accordance with Part E of this Appendix except that a license covering more
					 than one fee category of special nuclear material in Categories 1A through 1D
					 or source material in fee Categories 2A through 2C must pay a license fee for
					 the highest fee category assigned to the license.
c. Amendment fees - Applications for amendments must be
					 accompanied by the minimum amendment fee of $150. The Agency will compute the
					 final amendment fee based upon actual costs, but not more than $1,000., and the
					 applicant will be billed at the completion of the licensing action.
2. Material license fees will not be charged for orders
					 issued by the Agency pursuant to Part B.8 nor for amendments resulting
					 specifically from such orders. However, fees will be charged for approvals
					 issued pursuant to a specific exemption provision of the Agency's regulations
					 regardless of whether the approval is in the form of a license amendment,
					 letter of approval, safety evaluation report, or other form. In addition to the
					 fee shown, an applicant may be assessed an additional fee for sealed source and
					 device evaluations as shown in Categories 9A through 9D.
3. Types of inspections - Separate charges as shown in this
					 schedule will be the maximum amount assessed for each non-routine inspection,
					 which is performed. The amount that will be charged to the licensee will be
					 based on the staff time and contractual costs expended by the Agency.
4. A licensee who is authorized to use licensed radioactive
					 materials at multiple locations that are not immediately adjacent, or on the
					 same campus, will be assessed an additional 25% of their annual fee for
					 multiple sites. This does not apply to broad scope licensees.
5. The following scale of additional fees will be added to
					 the stated annual fee as applicable from the licensed quantity. If a licensee
					 is authorized for use under fee categories 1.A, 3.I.1, and/or 3.I.3 the total
					 number of gauges authorized under all types are cumulative. If more than one of
					 the remaining fee categories also applies to a licensee only the highest fee
					 will be charged.
License Category
1-4 gauges
5 to 9 gauges
10 gauges plus
1.A.
0
$ 500.00
$ 1000.00
3.I.1.
0
$ 500.00
$ 1000.00
3.I.3.
0
$ 500.00
$ 1000.00
License Category
1-10 gauges
11 to 20 gauges
21 gauges plus
3.I.2.
0
$ 500.00
$ 1000.00
6. The license fee categories 7.B.2 through 7.B.7 will be
					 charged the stated fee if any of the categories are authorized singly. There
					 will be no charge for a 7.B.1 authorization if the licensee holds a license for
					 7.B.2 through 7.B.7. If multiple categories are authorized an additional fee of
					 $1,000 per category will be added to the annual fee of the highest fee
					 category.