C.M.R. 10, 144, ch. 220, pt. C, app 144-220-C-A
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.
C.M.R. 10, 144, ch. 220, pt. C, app 144-220-C-A