§331.APPENDIX E. Primary Material Use Categories for Radioactive Material Licensees

Fee Category			Primary Material Use Category Description
MANUFACTURING/DISTRIBUTION
201A.	Broad Scope Manufacturing and/or Distributions – licenses (as specified in 32 Ill. Adm. Code 330.270) for possession and use of radioactive material for research and development, and processing or manufacturing radioactive material or items containing radioactive material for commercial distribution, including, but not limited to, nuclear pharmacy operations, or manufacturing of a chemical mixture, compound, solution or alloy which is listed in 32 Ill. Adm. Code 330.30.
201B.	Specific Manufacturing and /or Distribution – licenses for possession and use of greater than 37 GBq (1 Ci) of radioactive material for research and development, and processing or manufacturing radioactive material or items containing radioactive material for commercial distribution, including, but not limited to, manufacturing of a chemical mixture, compound, solution or alloy which is listed in 32 Ill. Adm. Code 330.30.
201C.	Nuclear Pharmacy and Limited Manufacturing and/or Distribution – this category of radioactive material licenses addresses two similar types of licenses, either:
	i)			nuclear pharmacy licenses for possession, use and distribution of radiopharmaceuticals and sealed sources to persons authorized pursuant to 32 Ill. Adm. Code 335; or
	ii)			Licenses for possession and use of not more than 37 GBq (1 Ci) of radioactive material for research and development, and processing or manufacturing of radioactive material for limited commercial distribution, including, but not limited to, manufacturing of a chemical mixture, radiolabeled compound, solution or alloy that is listed in 32 Ill. Adm. Code 330.30.
201D.	Distribution – licenses authorizing receipt, storage and distribution of radioactive material or items containing radioactive material, not involving processing or manufacturing of radioactive material.
IRRADIATORS
202A.	Category I Irradiator – licenses for possession and use of radioactive material as sealed sources in a gamma irradiator in which the sealed source is completely contained in a dry container constructed of solid material, the sealed source is shielded at all times, and human access to the sealed source and the volume undergoing irradiation is not physically possible because of the design of the irradiator.
202B.	Category II, III or IV Irradiator – licenses for possession and use of less than 370 TBq (10,000 Ci) of radioactive material as sealed sources in a controlled human access gamma irradiator in which the sealed source is either:
	i)			contained in a dry container constructed of solid materials, is fully shielded when not in use and is exposed within a radiation volume that is maintained inaccessible during use by an entry control system;
	ii)			Contained in a storage pool, the sealed source is shielded at all times, and human access to the sealed source and the volume undergoing irradiation is physically restricted in its design configuration and proper mode of use; or
	iii)			Contained in a storage pool, is fully shielded when not in use and is exposed within a radiation volume that is maintained inaccessible during use by an entry control system.
202C.	Category II, III or IV Irradiator – licenses for possession and use of 370 TBq (10,000 Ci) or more of radioactive material as sealed sources in a controlled human access gamma irradiator in which the sealed source is either:
	i)			Contained in a dry container constructed of solid materials, is fully shielded when not in use and is exposed within a radiation volume that is maintained inaccessible during use by an entry control system;
	ii)			Contained in a storage pool, the sealed source is shielded at all times, and human access to the sealed source and the volume undergoing irradiation is physically restricted in its design configuration and proper mode of use; or
	iii)			Contained in a storage pool, is fully shielded when not in use and is exposed within a radiation volume that is maintained inaccessible during use by an entry control system.
RESEARCH AND DEVELOPMENT
203A.	Broad Scope Research and Development – licenses (as specified in 32 Ill. Adm. Code 330.270) for possession and use of radioactive material for research and development that do not authorize commercial distribution.
203B.	Other Research and Development – licenses for possession and use of radioactive material for research and development that do not authorize commercial distribution.
	AGENCY NOTE:  The Agency will allow the non-commercial distribution of material to other licensees for the purpose of collaborative research and development.
PORTABLE AND FIXED GAUGES
204A.		Gas Chromatographs and Fixed X-Ray Fluorescence Analyzers – specific licenses for possession and use of radioactive material in sealed sources for use in gas chromatographs or fixed x-ray fluorescence analyzers.
204B.		Portable Gauges and Portable X-Ray Fluorescence Analyzers – specific licenses for possession and use of radioactive material as sealed sources for use in portable gauges or x-ray fluorescence analyzers.
204C.		Fixed Gauges – specific licenses for possession and use of radioactive material as sealed sources for use in fixed gauges.
SERVICE
205A.		Service – licenses that authorize services for other persons, including, but not limited to, testing of sealed sources for leakage or contamination, instrument calibration and sample analysis, but not including waste disposal transportation or radioactive waste broker services.  Medical service licensees include licensees that only transport sources and equipment to a client's facility, but do not authorize the medical use or administration of that material.  The medical use or administration of radioactive material to humans or animals shall be performed under a specific medical use license.
205B.		Nuclear Laundries – licenses for commercial collection and laundering of items contaminated with radioactive material.
205C.		Decontamination Facilities – licenses that authorize receipt of items contaminated with radioactive material for the purpose of decontaminating such items.
WIRELINE (Well-Logging)
206.			Wireline Service Operations (as defined in 32 Ill. Ad. Code 351) – licenses specifically authorizing use of radioactive material for wireline services, well surveys and tracer studies.
INDUSTRIAL RADIOGRAPHY
207.			Industrial Radiography (as defined in 32 Ill. Adm. Code 350) – licenses specifically authorizing use of radioactive material for industrial radiography at permanent or temporary jobsites.
MEDICAL/VETERINARY
208A.			Broad Scope Medical/Veterinary Use – broad scope licenses (as specified in 32 Ill. Adm. Code 330.270) authorizing diagnostic and/or therapeutic veterinary or human use of radioactive material.  These licenses may include research and development, or use of radioactive material in sealed sources contained in teletherapy or high dose rate remote afterloader devices.
208B.			Medical/Veterinary Use Including Teletherapy and/or High Dose Rate Remote Afterloader – licenses for diagnostic and/or therapeutic human or veterinary use of radioactive material that include authorization for possession and use of radioactive material as sealed sources contained in teletherapy or high dose rate remote afterloader devices for medical or veterinary use and for the irradiation of other items.   AGENCY NOTE:  Possession of a teletherapy unit that is out of service and in storage only does not means the primary radioactive material use category is the teletherapy category described in 208B.  Such licensees should review the other categories to determine their primary radioactive material use category.  If this is the only material possessed under a specific license, then see category 212A.
208C.			Medical/Veterinary Use – licenses for diagnostic and/or therapeutic human or veterinary use of radioactive material (i.e., 32 Ill. Adm. Code 335.5010 and/or 335.7010).
208D.			Diagnostic Use Only – licenses restricted to only the diagnostic human or veterinary use of radioactive material for uptake, dilution, excretion, imaging or localization studies, sealed sources for diagnosis; and in vitro kits (i.e., 32 Ill. Adm. Code 335.4010), except as specified in 32 Ill. Adm. Code 330.220(e).
208E.			Limited Medical/Veterinary Use – licenses restricted to only the human or veterinary use of radioactive material for uptake, dilution and excretion studies (i.e., 32 Ill. Adm. Code 335.3010).
208F.			Mobile Nuclear Medicine – licenses authorizing the receipt, possession and use of radioactive material for diagnostic or therapeutic human or veterinary use at temporary jobsites.   AGENCY NOTE:  Licensees wishing to establish mobile medical services involving High Dose Rate Remote Afterloaders for therapeutic use in humans or animals shall be licensed under Category 208B.
GENERAL LICENSES
209A.			Persons with Prepackaged Units for In Vitro Testing − persons who receive, acquire, possess or use prepackaged units for in vitro clinical or laboratory testing pursuant to the general license provided by 32 Ill. Adm. Code 330.220(e)(1).   AGENCY NOTE:  Prepackaged units may be known as in vitro kits or RIA kits.
209B.			Persons with Generally Licensed Devices – persons required to register with the Agency pursuant to 32 Ill. Adm. Code 330.220(a)(4).
SOURCE MATERIAL
210A.			Possession and Use of Source Material (as defined in 32 Ill. Adm. Code 310.20) and Byproduct Material (as defined in 32 Ill. Adm. Code 332.20) – licenses for possession and use of source material in recovery operations such as milling, in-site leaching, heap-leaching, ore buying stations, ion exchange facilities and in processing of ores containing source material for extraction of metals other than uranium or thorium, including licenses authorizing the possession of byproduct waste material (tailings) from source material recovery operations as well as licenses authorizing the possession and maintenance of a facility in a standby mode.
210B.			Possession and Use of Source Material (as defined in 32 Ill. Adm. Code 310.20) – licenses for possession and use of source material that require a specific radioactive materials license.  This does not include licenses authorizing manufacture and distribution of source material, no does it include specific licensees authorizing source material used for shielding or source material authorized for use in manufacturing operations as described in Material Use Categories 201A, B and C of this Section.
WASTE DISPOSAL AND TREATMENT FACILITIES
211A.			Low-Level Radioactive Waste Disposal Facilities – licenses issued pursuant to 32 Ill. Adm. Code 601 specifically authorizing the disposal of low-level radioactive waste away from the point of generation.
211B.			Low-Level Radioactive Waste Treatment Facilities – licenses specifically authorizing the receipt of low-level radioactive waste material from other persons for treatment away from the point of generation, and transfer to a person authorized to receive or dispose of the material.
211C.			Centralized Low-Level Radioactive Waste Storage Facilities – licenses specifically authorizing the receipt of low-level radioactive waste material from other persons for storage away from the point of generation, and transfer to a person authorized to receive or dispose of the material.
211D.			Other Low-Level Radioactive Waste – licenses authorizing other methodologies for disposal of low-level radioactive waste.
OTHER
212A.			Storage Only – licenses authorizing storage only of radioactive material, but does not include facilities described as Centralized Low-Level Radioactive Waste Storage Facilities.
212B.			Possession Incident to Exempt Distribution – licenses authorizing possession, receipt, storage and repackaging of byproduct radioactive material for eventual distribution to persons exempt under a specific license issued by the U.S. Nuclear Regulatory Commission.   AGENCY NOTE:  The U.S. Nuclear Regulatory Commission maintains sole authority to issue licenses authorizing distribution of exempt quantities of byproduct radioactive material.  However, those licenses do not authorize storage of the material at facilities in Illinois, therefore, a separate license must be obtained from the Agency for possession of the material.
212C.			Other – all other specific radioactive material licenses not specified elsewhere in this Appendix.
212D.			Reciprocity for Exhibition and Demonstration Only – licenses authorizing only exhibition or demonstration of devices for a period of not greater than 180 days in any 12-month period.
212E.			Sealed Source and Device Evaluation Maintenance Fee – a fee per active evaluation sheet maintained by the Agency excluding custom sealed source and device evaluation sheets.

 

(Source:  Amended at 39 Ill. Reg. 11981, effective August 17, 2015)