reglab/statecodes huggingface dataset:
Illinois Administrative Code › Title 32 - ENERGY › Part 332 - LICENSING REQUIREMENTS FOR SOURCE MATERIAL MILLING FACILITIES › Section 332.240 - Technical Criteria for Byproduct Material Disposal Sites - Control of Radiation Hazards

Current through Register Vol. 48, No. 28, July 12, 2024
a) Licensees
			 shall place an earthen cover over byproduct material at the end of source
			 material milling operations and shall close the disposal site in accordance
			 with a design which assures compliance with the requirements specified in
			 Section
			 332.170(d)
			 of this Part for a period of 1,000 years. Lands not decommissioned in
			 accordance with Section
			 332.150(b)(1)
			 of this Part shall be incorporated into the disposal area. Monitoring for total
			 radon after installation of an appropriately designed cover is not required.
			 Total radon emissions from cover material shall be estimated as part of
			 developing a closure plan. The standard for total radon release rate specified
			 in Section
			 332.170(d)
			 of this Part, however, applies only to emissions from byproduct material. In
			 computing required byproduct material area cover thicknesses, average moisture
			 in the cover shall be determined from similar soils and under similar
			 circumstances. The effects of any synthetic layer shall not be taken into
			 account in determining the calculated total radon release rate. If material
			 other than soil is proposed as cover material, it shall be demonstrated that
			 such material will not crack or degrade by differential settlement, weathering
			 or other mechanism, over long-term time intervals. Near surface cover material
			 within the top three meters shall not include byproduct material or rock that
			 contains elevated levels of radium; soils used for near surface cover shall be
			 essentially the same, as far as radioactivity is concerned, as that of
			 surrounding surface soils.
b) The
			 licensee shall ensure that disposal sites are closed in a manner that assures
			 no active maintenance will be required. The licensee shall address the
			 nonradiological hazards associated with the wastes in planning and implementing
			 closure. To the extent necessary to prevent threats to human health and the
			 environment, the licensee shall control or eliminate postclosure escape of
			 nonradiological hazardous constituents, leachate, contaminated rainwater or
			 waste decomposition products to groundwater, surface water or to the
			 atmosphere.
Illinois Administrative Code › Title 32 - ENERGY › Part 332 - LICENSING REQUIREMENTS FOR SOURCE MATERIAL MILLING FACILITIES › Section 332.260 - Financial Surety Requirements

Current through Register Vol. 48, No. 28, July 12, 2024
a)
			 The license applicant shall establish financial surety arrangements, prior to
			 the Agency authorization of commencement of operations, to assure the
			 availability of sufficient funds for decontaminating, decommissioning and
			 reclaiming the source material milling facility, including reclamation of any
			 tailings or waste disposal areas, and licensed site, as well as the
			 stabilization and closure of the byproduct material disposal site and the
			 long-term care payment.
b) An
			 acceptable surety arrangement may consist of cash or negotiable securities
			 deposited with the Agency, irrevocable assignments of savings or certificates
			 of deposit, or the deposit of an instrument executed by the applicant or
			 licensee and a corporate surety or financial institution with the Agency
			 designated as the beneficiary. However, self insurance, or any arrangement that
			 essentially constitutes self insurance (e.g., a contract with a State or
			 federal agency) will not satisfy the surety requirement since this provides no
			 additional assurance other than that which already exists through license
			 requirements. The value of the deposit shall be equal to or greater than the
			 amount of the surety required by subsection (c). Any surety arrangement must be
			 available in Illinois subject to judicial process and execution in the event
			 required for the purposes set forth in this Part.
c) The amount of funds to be ensured by the
			 surety arrangements shall be greater than or equal to the Agency approved
			 decommissioning cost estimates. Each decommissioning cost estimate shall be
			 submitted for review and Agency approval and shall contain:
1) A detailed cost estimate for the
			 decontamination, decommissioning, restoration and reclamation of buildings and
			 the licensed site, stabilization and closure of the disposal area and the
			 requirements of Section
			 332.270 for
			 the long-term care payment in the amount reflecting:
A) The cost of an independent contractor to
			 perform all decommissioning activities;
B) The cost of meeting Section
			 332.150
			 for unrestricted use;
C) The volume
			 of onsite subsurface material containing residual radioactivity that will
			 require remediation; and
D) A
			 contingency factor of 25 percent of the total decommissioning cost
			 estimate.
Illinois Administrative Code › Title 32 - ENERGY › Part 332 - LICENSING REQUIREMENTS FOR SOURCE MATERIAL MILLING FACILITIES › Section 332.270 - Long-Term Care Fund

Current through Register Vol. 48, No. 28, July 12, 2024
a) Prior to
			 termination of a source material milling or byproduct material license, a
			 minimum payment of $250,000 (1978 dollars - $811,000 in 2008 dollars) to cover
			 the cost of long-term care shall be paid by the licensee. If title and custody
			 to land and byproduct material are transferred to the State, the payment shall
			 be made to the State agency assuming custody. If title and custody are
			 transfered to a federal agency, the payment shall be deposited in the general
			 treasury of the United States.
b)
			 If the cost of long-term care is determined, on the basis of a site specific
			 evaluation, to be greater than $250,000 (1978 dollars - $811,000 in 2008
			 dollars), variance in the funding requirements shall be specified by the
			 Agency. The total amount of the payment must be such that, with an assumed 1
			 percent annual real interest rate, the collected funds will yield interest in
			 an amount sufficient to cover the annual costs of long-term care. The minimum
			 funding requirement will be adjusted annually prior to actual payment to
			 recognize inflation. The inflation rate to be used is that indicated by the
			 change in the Consumer Price Index published by the U.S. Department of Labor,
			 Bureau of Labor Statistics.
Illinois Administrative Code › Title 32 - ENERGY › Part 332 - LICENSING REQUIREMENTS FOR SOURCE MATERIAL MILLING FACILITIES › Section 332.280 - Land Ownership

Current through Register Vol. 48, No. 28, July 12, 2024
a) These
			 requirements relating to ownership of byproduct material, mineral rights and
			 disposal sites apply to all licenses terminated, issued or renewed after
			 January 1, 1990.
b) Unless exempted
			 by NRC, title to land (including any affected interests therein) which is used
			 for the disposal of byproduct material, or is essential to ensure the long-term
			 stability of the disposal area and the title to byproduct material shall be
			 transferred to the United States of America or the State of Illinois, at the
			 State's option, prior to the termination of the license. The applicant or
			 licensee shall attempt to obtain ownership of severable subsurface interests
			 and rights, and shall, in the event that certain rights cannot be obtained,
			 provide notification in local public land records of the fact that the land is
			 being used for the disposal of radioactive material and is subject to an NRC
			 license prohibiting the disruption and disturbance of the radioactive
			 material.
c) The use of the surface
			 or subsurface estates, or both, of the lands transferred to the State or to the
			 United States of America is prohibited unless the NRC determines by order that
			 such use will not endanger the public health, safety, welfare or environment.
			 The person who transferred such lands to the State or to the United States of
			 America shall have the right of first refusal with respect to such use of such
			 lands.
d) Byproduct material and
			 land transferred to the United States of America or the State in accordance
			 with this section shall be transferred without cost to the United States of
			 America or the State other than administrative and legal costs incurred in
			 carrying out such transfer.
e) The
			 provisions of this Section respecting transfer of title and custody to land and
			 byproduct material do not apply in the case of lands held in trust by the
			 United States of America for any Indian tribe or lands owned by such Indian
			 tribe subject to a restriction against alienation imposed by the United States
			 of America. Where such lands are used for the disposal of byproduct material,
			 the licensee shall enter into arrangements with the NRC as may be appropriate
			 to assure the long-term care of such lands by the United States of
			 America.
f) Prior to termination of
			 the license, the licensee shall provide evidence that it will comply with
			 ownership requirements of this Section.
Illinois Administrative Code › Title 32 - ENERGY › Part 332 - LICENSING REQUIREMENTS FOR SOURCE MATERIAL MILLING FACILITIES › Section 332.290 - Maintenance of Records, Reports, and Transfers

Current through Register Vol. 48, No. 28, July 12, 2024
a) Each licensee shall maintain any records
			 and make any reports in connection with the license activities as may be
			 required by the conditions of the license or by the rules, regulations and
			 orders of the Agency.
b) Records
			 that are required to be maintained by regulation or by license conditions shall
			 be maintained in a format allowing for easy access and review by the Agency,
			 for a time period specified in the applicable regulation or license condition.
			 If a record retention period is not otherwise specified, these records shall be
			 maintained and transferred to the officials specified in subsection (d) of this
			 Section as a condition of license termination unless the Agency otherwise
			 authorizes their disposition.
c)
			 Records that shall be maintained pursuant to this Part may be the original, or
			 a reproduced copy or microfilm if this reproduced copy or microfilm is capable
			 of producing copy that is clear and legible at the end of the required
			 retention period.
d) Copies of
			 records of the location and quantity of byproduct material contained in the
			 disposal site shall be transferred upon license termination to the Agency, the
			 agency responsible for long-term care, the U.S. Nuclear Regulatory Commission,
			 the chief executive of the nearest municipality, the chief executive of the
			 county in which the disposal site is located, the county zoning board or land
			 development and planning agency and the Governor.
e) Each licensee shall file a copy of its
			 financial report or a certified financial statement annually with the Agency in
			 order to update the information base for determining the continued financial
			 qualifications of the licensee.
f)
			 Each licensee shall submit status reports to the Agency. The reports shall be
			 submitted within 60 days after January 1 and July 1 of each year and shall
			 cover the previous 6 months of operation. The reports shall include:
1) Specification of the quantity of each of
			 the radionuclides released to unrestricted areas in liquid and gaseous
			 effluents;
2) The results of the
			 environmental monitoring program;
3) Data reported in a manner that will permit
			 the Agency to confirm the potential annual radiation doses to the
			 public;
4) A summary of licensee
			 survey and maintenance activities;
5) A summary of activities and quantities of
			 licensed material processed, stored, transferred or disposed of;
6) Any instances in which observed site,
			 facility, process or equipment characteristics were significantly different
			 from those described in the application for a license; and
7) If the quantities of radionuclides
			 released are more than 25 percent greater than those anticipated in the license
			 application, or if unanticipated maintenance is performed, a discussion of the
			 cause of the release or the reason for the maintenance.
Illinois Administrative Code › Title 32 - ENERGY › Part 333 - FEES FOR CALIBRATION SERVICES › Section 333.10 - Purpose and Scope

Current through Register Vol. 48, No. 28, July 12, 2024
Under the provisions of the Radiation Protection Act of 1990,
				the Illinois Department of Nuclear Safety (Department) is authorized to
				maintain a facility for the purpose of calibrating radiation detection and
				measuring instruments in accordance with national standards. The Department may
				make calibration services available to public or private entities within or
				outside of Illinois and may assess a reasonable fee for such services
				[420
				ILCS 40/25(g) ]. The Department has
				established such a facility, which has been accredited as a State Regional
				Calibration Laboratory by the Conference of Radiation Control Program
				Directors, Inc. This Part sets forth the procedures to be followed by persons
				who request the services of this facility, the terms and conditions under which
				such services will be provided and the fees that the Department will charge for
				providing calibration services.
Illinois Administrative Code › Title 32 - ENERGY › Part 333 - FEES FOR CALIBRATION SERVICES › Section 333.20 - Procedure for Requesting Calibration Services

Current through Register Vol. 48, No. 28, July 12, 2024
Any person may request the Department to perform calibration
				services described in this Part.
a)
			 Requests for such services shall be in writing and addressed to the Manager,
			 Calibration Facility, Illinois Department of Nuclear Safety, 1301 Knotts
			 Street, Springfield, Illinois 62703.
b) The request shall specify the type of
			 instrument for which calibration services are requested, by instrument name and
			 model number.
Illinois Administrative Code › Title 32 - ENERGY › Part 333 - FEES FOR CALIBRATION SERVICES › Section 333.30 - Conditions

Current through Register Vol. 48, No. 28, July 12, 2024
Any person who sends an instrument to the Department for
				calibration shall bear the cost and risk of transporting the instrument to the
				Department and returning the instrument to the sender. In addition, neither the
				Department nor the State of Illinois, nor any of their employees, agents or
				assignees shall be liable for any loss or damages, including without
				limitation, direct, consequential or special damages that may result in
				connection with the performance of calibration services.
Illinois Administrative Code › Title 32 - ENERGY › Part 333 - FEES FOR CALIBRATION SERVICES › Section 333.40 - Calibration Services

Current through Register Vol. 48, No. 28, July 12, 2024
a) The
			 Department provides the following calibration services under accreditation by
			 the Conference of Radiation Control Program Directors, Inc.
1) X-ray Calibrations. 5 beam codes at 32
			 mR/sec. This service is available for the Radcal MDH 1015 x-ray monitor only.
			 The available beam codes are:
BEAM
CODE
HALF-VALUE
LAYER
HOMOGENEITY
COEFFICIENT
L
80
1.81 mm Aluminum
0.59
L
100
2.82 mm Aluminum
0.59
M
30
0.36 mm Aluminum
0.65
M
50
1.03 mm Aluminum
0.64
M
100
4.96 mm Aluminum
0.73
2)
			 Gamma Ray Calibrations. 1 beam code. This service is available only for ion
			 chamber and energy compensated G-M tube instruments.
BEAM CODE
INTENSITIES
Cs-137
.005 - 40 R/hr
Illinois Administrative Code › Title 32 - ENERGY › Part 333 - FEES FOR CALIBRATION SERVICES › Section 333.50 - Fee Schedule

Current through Register Vol. 48, No. 28, July 12, 2024
a)
Radcal MDH x-ray monitor calibration (maximum 2
						  probes)
$235.00 /ea
b)
G-M ion chamber survey instrument or microrem
						  meter
$75.00 /ea
c)
Reference quality ion chamber calibration (1 point, 1
						  beam quality, either gamma or x-ray)
$100.00 /ea
d)
Pocket dosimeter calibration
$5.00/per dosimeter ($50 minimum charge)
e)
Count-rate instrument
$75.00/ea
each additional probe
$25.00
f)
Handling charge for any non-operational instrument
						  received for calibration
$25.00
g)
Other services
$100.00/hour
Illinois Administrative Code › Title 32 - ENERGY › Part 333 - FEES FOR CALIBRATION SERVICES › Section 333.60 - Other Provisions

Current through Register Vol. 48, No. 28, July 12, 2024
a) The
			 Department will not repair or service non-functioning instruments. However, if
			 batteries or other parts are missing from instruments sent to the Department,
			 the Department will so advise the person sending the instrument and request
			 that the missing parts be supplied. If the person sending the instrument fails
			 to supply the needed items, the Department will return the instrument subject
			 to payment of the handling fee provided in this Part.
b) Upon completing the calibration services,
			 the Department will return the instrument along with a bill for services
			 rendered to the person seeking the calibration service.
c) Payment for services shall be by check or
			 money order, made payable to the Illinois Department of Nuclear
			 Safety.
d) Upon receipt of the full
			 amount of the billing, the Department will provide a copy of the records and
			 results of the calibration to the sender.
e) The Department upon written request may
			 waive all or a portion of any fee established in this Part upon making a
			 determination that such a waiver would be in the best interests of the State of
			 Illinois. Examples of situations in which the Department may consider a waiver
			 include:
1) When requested to service the
			 calibration of instruments used by federal, state or local agencies in Illinois
			 for purposes of assuring protection of the public health and safety through a
			 cooperative agreement with the Department.
2) When the person requesting the calibration
			 service provides a service (such as making training or other resources
			 available) to the Department in exchange for calibration services.
Illinois Administrative Code › Title 32 - ENERGY › Part 334 - FEES FOR BY-PRODUCT MATERIAL LICENSES › Section 334.10 - Purpose and Scope

Current through Register Vol. 48, No. 28, July 12, 2024
a) The purpose
			 of this Part is to establish an annual fee which shall be imposed on the owner
			 or operator of any property that has been used in whole or in part for the
			 milling of source material and is being used for the storage or disposal of
			 by-product material, equal to $2 per cubic foot of by-product material being
			 stored or disposed of by the facility. However, no fees shall be collected from
			 any State, county, municipal, or local governmental agency. Moneys collected
			 shall be deposited by the Department into the By-product Material Safety Fund
			 (Fund). [420 ILCS 42/15
			 ]
b) The Department is authorized
			 to spend money from the Fund for the following purposes:
(1) the costs of monitoring, inspecting, and
			 otherwise regulating the storage and disposal of by-product material, wherever
			 located;
(2) the costs of
			 undertaking any necessary maintenance, decommissioning activities, cleanup,
			 responses to radiation emergencies, or remedial action that may be necessary in
			 connection with by-product materials;
(3) the costs incurred by the Department
			 arising from the transportation of the by-product material from a storage or
			 unlicensed disposal location to a licensed permanent disposal facility.
			 [420 ILCS
			 42/15(b) ]
Illinois Administrative Code › Title 32 - ENERGY › Part 334 - FEES FOR BY-PRODUCT MATERIAL LICENSES › Section 334.20 - Definitions

Current through Register Vol. 48, No. 28, July 12, 2024
As used in this Part, the following definitions apply:
"Act" means the Uranium and Thorium Mill Tailings Control Act
				[420 ILCS 42 ].
"By-product material" means the tailings or wastes produced by
				the extraction or concentration of uranium or thorium from any ore processed
				primarily for its source material content, including discrete surface wastes
				resulting from underground solution extraction processes but not including
				underground ore bodies depleted by such solution extraction processes.
"Department" means the Department of Nuclear Safety.
"Director" means the Director of the Department of Nuclear
				Safety.
"Person" means any individual, corporation, partnership, firm,
				association, trust, estate, public or private institution, group, agency,
				political subdivision of this State, any other State or political subdivision
				or agency thereof, and any legal successor, representative, agent, or agency of
				the foregoing, other than the United States Nuclear Regulatory Commission, or
				any successor thereto, and other than federal government agencies licensed by
				the United States Nuclear Regulatory Commission, or any successor
				thereto.
"Source material" means uranium, thorium, or any other material
				that the Department declares by order to be source material after the United
				States Nuclear Regulatory Commission or its successor has determined the
				material to be source material; or ores containing one or more of those
				materials in such concentration as the Department declares by order to be
				source material after the United States Nuclear Regulatory Commission or its
				successor has determined the material in such concentration to be source
				material.
Illinois Administrative Code › Title 32 - ENERGY › Part 334 - FEES FOR BY-PRODUCT MATERIAL LICENSES › Section 334.30 - Payment of Fees into the By-Product Material Safety Fund

Current through Register Vol. 48, No. 28, July 12, 2024
The storage fees assessed under this Part are separate and
				distinct from any license fees imposed under 32 Ill. Adm. Code 331.
a) The annual fee of $2 per cubic foot shall
			 be assessed on the quantity of by-product material in the owner or operator's
			 possession on January 1 of each year. The Department shall provide notice of
			 the amount of the fee to each owner by certified mail by February 1 of each
			 year.
b) The quantity of material
			 for the assessment in subsection (a) above does not include by-product material
			 that has been at the facility for 180 days or less.
c) In connection with settling litigation
			 regarding the amount of the fee to be imposed, the Director may enter into an
			 agreement with the owner or operator of any facility specifying that the fee to
			 be imposed shall not exceed $26,000,000 in any calendar year [420 ILCS
			 42/15(a) ].
d) Beginning in 1995, the annual fee shall be
			 payable in equal installments on June 1, 1995, September 1, 1995, December 1,
			 1995 and December 31, 1995.
e)
			 Beginning in 1996, the annual fee shall be payable in equal quarterly
			 installments due March 31, June 30, September 30 and December 31.
f) Payments shall be by check or money order
			 made payable to the Illinois Department of Nuclear Safety.
g) If the owner or operator wishes to contest
			 the annual fee assessment, the owner or operator may petition the Department to
			 request a hearing. This petition must be received by the Department on or
			 before the date the payment is due. If a hearing is granted, it shall be
			 conducted in accordance with 32 Ill. Adm. Code 200.
h) Any person failing to pay the fees as
			 specified in this Section may be issued a Preliminary Order and Notice of
			 Opportunity for Hearing, and may be subject to a civil penalty. This civil
			 penalty shall not exceed 4 times the amount of the fees not paid [420 ILCS
			 42/40(b) ].
Illinois Administrative Code › Title 32 - ENERGY › Part 334 - FEES FOR BY-PRODUCT MATERIAL LICENSES › Section 334.40 - Reimbursement of Fees from the By-Product Material Safety Fund

Current through Register Vol. 48, No. 28, July 12, 2024
a) An owner or
			 operator who incurs costs in connection with the decontamination or
			 decommissioning of the storage or disposal facility or other properties
			 contaminated with by-product material is entitled to have those costs promptly
			 reimbursed from the Fund.
b) An
			 owner or operator of a facility shall submit a request for reimbursement to the
			 Director subject to audit by the Director.
c) The Director shall, upon receipt of a
			 request, give written notice approving or disapproving each of the owner or
			 operator's request for reimbursement within 60 days.
d) The Director shall approve requests for
			 reimbursement unless:
1) The Director finds
			 that the amount is excessive, erroneous, or otherwise inconsistent with
			 subsection (b) above; or
2) The
			 Director finds that the amount is inconsistent with any license or license
			 amendments issued in connection with that owner or operator's decontamination
			 or decommissioning plan.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 335.10 - Purpose and Scope

Current through Register Vol. 48, No. 28, July 12, 2024
This Part contains the requirements and provisions for the
				  medical use of radioactive material and for issuance of specific licenses
				  authorizing the medical use of this material. This Part allows use of
				  radioactive material strictly for medical use as authorized by an authorized
				  user and does not allow use for training, demonstration or other purposes
				  unrelated to the treatment of patients. These requirements and provisions
				  provide for the radiation safety of workers, the general public, patients and
				  human research subjects. The requirements of this Part are in addition to, and
				  not in substitution for, others in 32 Ill. Adm. Code: Chapter II, Subchapters b
				  and d. The requirements of 32 Ill. Adm. Code: Chapter II, Subchapters b and d
				  apply to applicants and licensees subject to this Part unless specifically
				  exempted.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 335.15 - Incorporations by Reference

Current through Register Vol. 48, No. 28, July 12, 2024
All rules, standards and guidelines of agencies of the United
				  States or nationally recognized organizations or associations that are
				  incorporated by reference in this Part are incorporated as of the date
				  specified in the reference and do not include any later amendments or editions.
				  Copies of these rules, standards and guidelines that have been incorporated by
				  reference are available for public inspection and copying at the Illinois
				  Emergency Management Agency, 1035 Outer Park Drive, Springfield,
				  Illinois.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 335.30 - License Required

Current through Register Vol. 48, No. 28, July 12, 2024
a) A
				person shall manufacture, produce, acquire, receive, possess, prepare, use or
				transfer radioactive material for medical use only in accordance with a
				specific license issued by the Agency, the U.S. Nuclear Regulatory Commission,
				an Agreement State, or as allowed by subsection (b)(1) or (2) of this
				Section.
b) A specific license is
				not needed for an individual who:
1) Receives,
				possesses, uses or transfers radioactive material in accordance with this Part
				under the supervision of an authorized user as provided in Section
				335.1050 unless
				prohibited by license condition; or
2) Prepares unsealed radioactive material for
				medical use in accordance with this Part under the supervision of an authorized
				nuclear pharmacist or authorized user as provided in Section
				335.1050 unless
				prohibited by license condition.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 335.35 - Suppliers for Sealed Sources or Devices for Medical Use

Current through Register Vol. 48, No. 28, July 12, 2024
For medical use, a licensee shall only use:
a) Sealed sources or devices manufactured,
				labeled, packaged, and distributed in accordance with a license issued under 32
				Ill. Adm. Code 330 or equivalent requirements of the U.S. Nuclear Regulatory
				Commission or an Agreement State.
b) Sealed sources or devices non-commercially
				transferred from an Agency, U.S. Nuclear Regulatory Commission or an Agreement
				State medical use licensee.
c)
				Teletherapy sources manufactured and distributed in accordance with a license
				issued under 32 Ill. Adm. Code 330 or equivalent requirements of the U.S.
				Nuclear Regulatory Commission or an Agreement State.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 335.40 - License Amendments

Current through Register Vol. 48, No. 28, July 12, 2024
For specific licenses issued pursuant to 32 Ill. Adm. Code
				  330.260(a)
				  or
				  330.260(b),
				  a licensee's management shall apply for and shall receive a license
				  amendment:
a) Before using radioactive
				material for any use not permitted by the license;
b) Before permitting anyone to work as an
				authorized user, authorized medical physicist, or ophthalmic physicist under
				the license, except:
1) For a visiting
				authorized user, as described in Section
				335.1060;
2) For an authorized user, an individual who
				meets:
A) The requirements in
				335.9180;
				and
B) The applicable board
				certification requirements in subsections
				335.9030(a),
				335.9040(a),
				335.9050(a),
				335.9060(a),
				335.9070(a),
				335.9100(a),
				335.9130(a),
				and
				335.9140(a);
3) For an authorized medical
				physicist, an individual who meets the requirements in subsection
				335.9150(a)
				and Section 335.9180;
4) An
				individual who is identified as an authorized user, an authorized medical
				physicist, or an ophthalmic physicist on an Agency, U.S. Nuclear Regulatory
				Commission, or Agreement State license or other equivalent permit recognized by
				the Agency that authorizes the use of byproduct material in medical use, on a
				permit issued by the Agency, the U.S. Nuclear Regulatory Commission or an
				Agreement State specific license of broad scope that is authorized to permit
				the use of byproduct material in medical use, or on a permit issued by the U.S.
				Nuclear Regulatory Commission master material licensee that is authorized to
				permit the use of byproduct material in medical use;
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 335.45 - Notifications

Current through Register Vol. 48, No. 28, July 12, 2024
a) For specific
				licenses issued pursuant to 32 Ill. Adm. Code
				330.260(a)
				or (b), a licensee shall provide the Agency,
				no later than 30 days after the date that the licensee permits an individual to
				work under the provisions of subsection
				335.40(b)
				as an authorized user, authorized medical physicist, or ophthalmic physicist:
1) A copy of the board certification and, as
				appropriate, verification of completion of:
A)
				Training for the authorized medical physicist under subsection
				335.9150(d);
B) Any additional case experience required in
				subsection
				335.9050(b)(2)(F)
				for an authorized user under Section
				335.5010;
				or
C) Device specific training in
				subsection
				335.9140(d)
				for the authorized user under Section
				335.8010;
				or
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 335.60 - Provisions for the Protection of Human Research Subjects

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee may conduct research involving
				human research subjects only if it uses the radioactive materials specified on
				its license for the uses authorized on its license.
b) If the research is conducted, funded,
				supported or regulated by another Federal agency that has implemented the
				Federal Policy for the Protection of Human Subjects (Federal Policy), the
				licensee shall, before conducting research:
1)
				Obtain review and approval of the research from an Institutional Review Board,
				as defined and described in the Federal Policy; and
2) Obtain informed consent, as defined and
				described in the Federal Policy, from the human research subject.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 335.1040 - Authorities and Responsibilities for the Radiation Protection Program

Current through Register Vol. 48, No. 28, July 12, 2024
a) In addition to
				the radiation protection program requirements of 32 Ill. Adm. Code
				340.110,
				a licensee's management shall approve in writing:
1) Requests for a license application,
				renewal or amendment before submittal to the Agency.
2) Any individual before allowing that
				individual to work as an authorized user or authorized medical
				physicist.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 335.1050 - Supervision

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee who
				permits the receipt, possession, use or transfer of radioactive material by an
				individual other than a physician under the supervision of an authorized user
				as allowed by Section
				335.30 of this
				Part shall:
1) Document instruction provided
				to the supervised individual, prior to assuming duties requiring the handling
				of radioactive materials, regarding the principles of radiation safety
				appropriate to that individual's use of radioactive material;
2) Review the supervised individual's use of
				radioactive material, provide reinstruction and review records kept to reflect
				this use;
3) Require the authorized
				user or Radiation Safety Officer to be available to communicate with the
				supervised individual; and
4) Allow
				only those individuals who are accredited by the Agency pursuant to 32 Ill.
				Adm. Code
				401.100
				or exempt from accreditation by 32 Ill. Adm. Code
				401.30,
				and designated in writing by the licensee, to administer radionuclides or
				radiation to patients.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 335.1060 - Authorized User and Visiting Authorized User

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee shall assure that only
				authorized users of radioactive material:
1)
				Select or establish written criteria for the selection of the patients to
				receive radioactive material or radiation therefrom; and
2) Prescribe the radiopharmaceutical dosage
				or radiation dose to be administered.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 335.1080 - Report and Notification of a Medical Event

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee shall report any event as a
				medical event, except for an event that results from patient intervention, in
				which:
1) The administration of a radioactive
				material or radiation from radioactive material, except permanent implant
				brachytherapy, results in:
A) A dose that
				differs from the prescribed dose or dose that would have resulted from the
				prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5
				Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent
				to the skin; and
i) The total dose delivered
				differs from the prescribed dose by 20 percent or more;
ii) The total dosage delivered differs from
				the prescribed dosage by 20 percent or more or falls outside the prescribed
				dosage range; or
iii) The
				fractionated dose delivered differs from the prescribed dose for a single
				fraction, by 50 percent or more.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 335.1100 - Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee shall
				report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose
				equivalent that is a result of an administration of radioactive material or
				radiation from radioactive material to a pregnant individual unless the dose to
				the embryo/fetus was specifically approved, in advance, by the authorized
				user.
b) A licensee shall report
				any dose to a nursing child that is a result of an administration of
				radioactive material to a breast-feeding individual that:
1) Is greater than 50 mSv (5 rem) total
				effective dose equivalent; or
2)
				Has resulted in unintended permanent functional damage to an organ or a
				physiological system of the child, as determined by a physician.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 335.1110 - Written Directives

Current through Register Vol. 48, No. 28, July 12, 2024
a) A
				written directive shall be dated and signed by an authorized user before the
				administration of I-131 sodium iodide greater than 1.11 MBq (30 µCi), any
				therapeutic dosage of unsealed radioactive material or any therapeutic dose of
				radiation from radioactive material. If, because of the emergent nature of the
				patient's condition, a delay in order to provide a written directive would
				jeopardize the patient's health, an oral directive is acceptable. The
				information contained in the oral directive shall be documented as soon as
				possible in writing in the patient's record. A written directive shall be
				prepared within 48 hours after the oral directive.
b) The written directive shall contain the
				patient's or human research subject's name and the following information:
1) For any administration of quantities
				greater than 1.11 MBq (30 µCi) of sodium iodide I-131, the
				dosage.
2) For an administration of
				a therapeutic dosage of unsealed radioactive material other than sodium iodide
				I-131, the radioactive drug, dosage and route of administration.
3) For gamma stereotactic radiosurgery, the
				total dose, treatment site, and values for the target coordinate settings per
				treatment for each anatomically distinct treatment site.
4) For teletherapy, the total dose, dose per
				fraction, number of fractions and treatment site.
5) For high dose-rate remote afterloading
				brachytherapy, the radionuclide, treatment site, dose per fraction, number of
				fractions and total dose.
6) For
				permanent implant brachytherapy:
A) Before
				implantation: the treatment site, the radionuclide, and the total source
				strength; and
B) After implantation
				but before the patient leaves the post-treatment recovery area: the treatment
				site, the number of sources implanted, the total source strength implanted, and
				the date; or
7) For all
				other brachytherapy, including low, medium and pulsed dose rate remote
				afterloaders:
A) Before implantation:
				treatment site, the radionuclide and dose; and
B) After implantation but before completion
				of the procedure: the radionuclide, treatment site, number of sources, total
				source strength, and exposure time (or the total dose) and date.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 335.1120 - Procedures for Administrations Requiring a Written Directive

Current through Register Vol. 48, No. 28, July 12, 2024
a) For any
				administration requiring a written directive, the licensee shall develop,
				implement, and maintain written procedures to provide high confidence that:
1) The patient's or human research subject's
				identity is verified before each administration; and
2) Each administration is in accordance with
				the written directive.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 335.2010 - Possession, Use and Calibration of Instruments Used to Measure the Activity of Unsealed Radioactive Material

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				For direct measurements performed in accordance with Section
				335.2030,
				the licensee shall possess and use instrumentation to measure the activity of
				unsealed byproduct material before it is administered to each patient or human
				research subject.
b) A licensee
				shall calibrate the instrumentation required in subsection (a) in accordance
				with nationally recognized standards or the manufacturer's
				instructions.
c) A licensee shall
				maintain a record of instrument calibrations required by subsection (b) for 5
				years. The records shall include the model and serial number of the instrument,
				the date of the calibration, the results of the calibration, the name of the
				individual who performed the calibration and a copy of the national standard or
				manufacturer's instructions used to perform the calibration.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 335.2030 - Assay of Radiopharmaceutical Dosages

Current through Register Vol. 48, No. 28, July 12, 2024
a) A licensee shall determine and record the
				activity of each dosage before medical use.
b) For a unit dosage, this determination
				shall be made by:
1) Direct measurement of
				radioactivity by the licensee; or
2) For radiopharmaceuticals with a photon
				emitting radionuclide not requiring a written directive, a decay correction
				based on the activity or activity concentration determined by:
A) A manufacturer or preparer authorized
				under Section
				335.30 or
				equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements;
				or
B) An Agency, U.S. Nuclear
				Regulatory Commission or Agreement State licensee for use in research in
				accordance with a Radioactive Drug Research Committee-approved protocol or an
				Investigational New Drug (IND) protocol accepted by FDA; or
C) A PET radioactive drug producer licensed
				under 32 Ill. Adm. Code
				330.260(c)(23)
				 or the equivalent regulations of the U.S.
				Nuclear Regulatory Commission or an Agreement State.
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 335.2040 - Authorization for Calibration, Transmission, Attenuation Correction and Reference Sources

Current through Register Vol. 48, No. 28, July 12, 2024
Any person authorized by Section
				  335.30 for
				  medical use of radioactive material may receive, possess and use the following
				  radioactive material for check, calibration, transmission, attenuation
				  correction and reference use. Reference sources containing radioactive material
				  authorized under this Part shall not be used for medical use except in
				  accordance with the requirements in Section
				  335.6010.
				  Sealed sources shall not be combined (i.e. bundled or aggregated) to create an
				  activity greater than the maximum activity of any single sealed source
				  authorized under this Section. Sealed sources are authorized as follows:
a) Sealed sources not exceeding 1.11 GBq (30
				mCi) each, manufactured and distributed by a person licensed under Section
				335.30 or
				equivalent U.S. Nuclear Regulatory Commission or Agreement State
				regulations.
b) Sealed sources, not
				exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to
				redistribute the sealed sources manufactured and distributed by a person
				licensed under Section
				335.30 or
				equivalent U.S. Nuclear Regulatory Commission or Agreement State regulations,
				providing the redistributed sealed sources are in the original packaging and
				shielding and are accompanied by the manufacturer's approved
				instructions.
c) Any radioactive
				material with a half-life not greater than 120 days in individual amounts not
				to exceed 0.56 GBq (15 mCi).
d) Any
				radioactive material with a half-life longer than 120 days in individual
				amounts not to exceed the smaller of 7.4 MBq (200 mCi) or 1000 times the
				quantities in Appendix B of 32 Ill. Adm. Code 330.
e) Technetium-99m in amounts as
				needed.
f) Yttrium-90 in individual
				amounts not to exceed 4.6 GBq (125 mCi).
g) Gadolinium-153 in individual amounts not
				to exceed 22.2 GBq (600 mCi).
Illinois Administrative Code › Title 32 - ENERGY › Part 335 - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 335.2060 - Labeling and Use of Vials and Syringes

Current through Register Vol. 48, No. 28, July 12, 2024
a) Each syringe and vial that contains
				unsealed radioactive material shall be labeled to identify the
				radiopharmaceutical. Each syringe shield and vial shield shall also be labeled
				unless the label on the syringe or vial is visible when shielded.
b) A licensee shall use syringe radiation
				shields unless the use of a shield is contraindicated for an individual
				patient.
AGENCY NOTE: The use of a syringe radiation shield could be
				  contraindicated if a patient presented a venous anatomy poorly suited for
				  venipuncture.
AGENCY NOTE: The use of a syringe radiation shield could
					 be contraindicated if a patient presented a venous anatomy poorly suited for
					 venipuncture.