TITLE 32: ENERGY CHAPTER II: DEPARTMENT OF NUCLEAR SAFETY SUBCHAPTER b: RADIATION PROTECTION PART 410 RADIATION INSPECTORS AND INSPECTIONS Section 410.10 Policy and Scope 410.20 Radiation Inspectors Education/Experience and Instrumentation Requirements 410.30 Approval of Application and Application/Registration Fees 410.40 Radiation Installations and Classifications 410.50 Inspection Procedures 410.60 Choice of Type of Inspector, Inspection Fees and Inspection Schedule 410.70 Separate Installation 410.80 Change in Operator ILLUSTRATION A NEW FACILITY FILING ANNIVERSARY DATE (CLASS C FACILITY USED AS AN EXAMPLE) ILLUSTRATION B EXISTING FACILITY FILING ANNIVERSARY DATE (CLASS B FACILITY USED AS AN EXAMPLE) AUTHORITY: Implementing and authorized by Sections 4 and 8.9 of the Radiation Protection Act (Ill. Rev. Stat. 1989, ch. 111«, pars. 214 and 218.9). SOURCE: Adopted at 8 Ill. Reg. 23209, effective November 19, 1984, amended at 9 Ill. Reg. 17821, effective November 5, 1985; amended at 10 Ill. Reg. 13265, effective July 29, 1986; amended at 13 Ill. Reg. 342, effective January 30, 1989; amended at 14 Ill. Reg. 13638, effective August 13, 1990. Section 410.10 Policy and Scope a) The Radiation Protection Advisory Council shall recommend criteria to the Department of Nuclear Safety (Department) for education, experience and instrumentation standards for inspectors of radiation machines in radiation installations. b) The Department shall: 1) Establish radiation machine inspection standards for the protection of the public health. 2) Maintain and provide, on request, a list of persons approved as qualified nondepartment inspectors of radiation machines. 3) Review the findings and inspection procedures of qualified nondepartment inspectors. (Source: Amended at 13 Ill. Reg. 342, effective January 30, 1989) Section 410.20 Radiation Inspectors Education/Experience and Instrumentation Requirements a) An individual is considered qualified to be an inspector of radiation machines if his or her credentials satisfy the criteria which have been recommended by the Radiation Protection Advisory Council (See Section 8.9 of the Radiation Protection Act (the Act) Ill. Rev. Stat. 1987, ch. 111«, par. 218.9) and approved by the Department as set forth in this Section. b) Inspections and testing of radiation machines shall be conducted by designated Department personnel or by other qualified nondepartment inspectors. Approval of the nondepartment inspectors shall be based upon meeting the education/certification and experience in clinical practice requirements indicated in any one of the criteria set forth below. Education and/or Experience Certification 1) Certification by the and experience included American Board of in certification. Radiology in radio- logical physics or diagnostic radio- logical physics 2) Certification by the and experience included American Board of in certification. Health Physics 3) Doctorate (Ph.D. and 6 months of applied degree) in health x-ray radiation physics, medical protection radiological physics experience. or physics 4) Master's (MS/MA) degree and1 year of applied in health physics, x-ray radiation medical radiological protection physics or physics experience. 5) Bachelor's (BS/BA) and 2 years of applied degree in health x-ray radiation physics, medical protection radiological physics experience. or physics 6) Master's (MS/MA) or and 3 years of applied Bachelor's (BS/BA) x-ray radiation degree in a physical protection science or mathematics experience. 7) Registered Radiologic and 5 years of applied Technologist x-ray radiation protection experience. c) Upon initial application to the Department, and as a condition for approval as a qualified inspector, an applicant shall submit verification of access to instruments which will enable the individual to perform inspections and tests in accordance with Department standards. (Source: Amended at 13 Ill. Reg. 342, effective January 30, 1989) Section 410.30 Approval of Application and Application/Registration Fees a) An applicant for approval by the Department as a qualified nondepartment inspector shall submit a complete and legible application on a form prescribed and furnished by the Department. The Department shall assess each applicant an application fee, as prescribed in Section 8.9(e) of the Act, which will serve as a registration fee for the remainder of the calendar year. The application fee is non-refundable. b) The Department shall provide written notification to the applicant concerning the status of the application within 4 weeks after receipt of the application. If approval is granted, the applicant shall receive a "Notice of Approval" and the individual's name and address shall be entered in the record of persons approved as qualified nondepartment inspectors of radiation machines. c) The Department shall assess all qualified nondepartment inspectors an annual registration fee, as prescribed in Section 8.9(e) of the Act, payable on January 1 of each year. The registration fee is non-refundable. Failure of the inspector to remit the appropriate registration fee will cause the Department to remove the individual's name from the record specified in subsection (b). If an individual's name is removed from the record of qualified nondepartment inspectors, the Department will not accept radiation machine inspection reports completed on or after the date the inspector's name was removed from the record. d) If an individual's name is removed from the record of qualified nondepartment inspectors, he or she may reapply for approval by the Department in accordance with the requirements of subsections (a) and (b). (Source: Amended at 13 Ill. Reg. 342, effective January 30, 1989) Section 410.40 Radiation Installations and Classifications a) Class A - shall include all radiation installations utilizing radiation machines located in dental offices and clinics and used solely for dental diagnosis, or located in veterinary offices and used solely for diagnosis, and all installations using commercially manufactured cabinet radiographic/fluoroscopic radiation machines and electron microscopes. (See Section 8.9(f) of the Act.) b) Class B - shall include all radiation installations utilizing radiation machines located in offices or clinics of persons licensed under the "Medical Practice Act of 1987" (Ill. Rev. Stat. 1987, ch. 111, par. 4400-1 et seq.) or under the "Podiatric Medical Practice Act of 1987" (Ill. Rev. Stat. 1987, ch. 111, par. 4801 et seq.) and used solely for diagnosis or therapy and all installations using spectroscopy radiation machines, non- commercially manufactured cabinet radiographic/fluoroscopic radiation machines, portable radiographic/fluoroscopic radiation machines, non-cabinet baggage/package fluoroscopic radiation machines and electronic beam welders. (See Section 8.9(f) of the Act.) c) Class C - shall include all radiation installations utilizing radiation machines which are not classified as Class A or Class B installations. Class C shall include but not be limited to radiation machines located in hospitals and educational institutions and all installations using diffraction radiation machines, open radiography radiation machines, closed radiographic/fluoroscopic radiation machines and radiation machines used as gauges. Test booths, tubs, baths or rooms used by manufacturing, assembly or repair facilities for testing radiation machines shall be categorized as Class C radiation installations. (See Section 8.9(f) of the Act.) d) Radiation installations utilizing radiation machines that are in different classes (see subsections (a), (b), and (c) above) will be assigned a classification based upon the machine(s) requiring the most frequent inspecting and testing. (See Section 410.60(d).) (Source: Amended at 13 Ill. Reg. 342, effective January 30, 1989) Section 410.50 Inspection Procedures a) It will be the responsibility of the Departmental inspector and the qualified nondepartment inspector to: 1) Establish that radiation machines are being maintained and operated in accordance with standards established by the Department to protect the public health as set forth in 32 Ill. Adm. Code 310, 320, 340, 350, 360, 380, 390, 400, and 401; and 2) Consult with the operator to ascertain the identity of individuals who use the equipment to administer ionizing radiation to human beings (See 32 Ill. Adm. Code 360.30(a)(4) and 360.30(i)) and to verify that those named individuals are licensed in accordance with state law, are accredited by the Department, or are exempt from such requirements in accordance with 32 Ill. Adm. Code 401.30. b) It will be the responsibility of the qualified nondepartment inspector to provide timely, accurate, and thorough inspection reports and certify all survey findings on appropriate Department radiation machine inspection forms. A survey instruction manual will be provided to each inspector by the Department for the completion of this requirement. c) It will be the responsibility of the qualified nondepartment inspector to perform radiation measurements with instruments which are sufficiently sensitive to determine compliance with the standards established by the Department under this section. These instruments shall be calibrated with devices which have no more than a three step (tertiary) calibration, traceable to the National Bureau of Standards. d) It will be the responsibility of the qualified nondepartment inspector to certify on appropriate Department radiation machine inspection forms for each inspection that his/her instruments have been properly calibrated at intervals not to exceed 12 months prior to each inspection. e) It will be the responsibility of the qualified nondepartment inspector to maintain, for a period of at least 3 inspection cycles (See Section 410.60(d)), a copy of all inspection data gathered during inspections of radiation machines conducted in accordance with subsections (a)(1) and (2) above. f) It will be the responsibility of each operator of a radiation installation, upon completion of the inspection and testing of the radiation machine(s) by a qualified nondepartment inspector, to forward a clear, legible copy of the inspection report along with the appropriate filing fee to the Department. (See Section 410.60(a) (3).) In the event the Department has reason to question the accuracy or thoroughness of a radiation machine inspection report due to the submission of incomplete or contradictory information or wherein it is not possible to verify compliance with the Department's standards for operating such equipment in accordance with 32 Ill. Adm. Code 310, 320, 340, 350, 360, 380, 390, 400 and 401, the report will be returned to the operator for completion, correction or for reinspection as appropriate. Forms returned to the operator for corrections or completion must be returned to the Department within 30 days of receipt. g) Within 30 days of receipt of a completed radiation machine inspection report, the Department will provide results to the operator regarding the inspector's survey. h) Reviews of qualified nondepartment inspectors' survey findings and inspection procedures will be conducted by the Department. Items and procedures considered as part of such reviews shall include, but need not be limited to, one or more of the following: 1) The type of instruments used by the inspector; 2) The procedures for the use of these instruments to determine compliance with Department standards; 3) The thoroughness and accuracy of inspection reports; 4) Use of other documents and investigative procedures to assure compliance with Department standards listed in subsection (a); and 5) Reinspection and testing by the Department of the radiation machines, records, and associated operating procedures of a radiation installation that were inspected by a qualified nondepartment inspector. (Source: Amended at 13 Ill. Reg. 342, effective January 30, 1989) Section 410.60 Choice of Type of Inspector, Inspection Fees and Inspection Schedule a) Operators of radiation installations shall assure that the installations, including all radiation machines located therein, are registered with the Department in accordance with the provisions of 32 Ill. Adm. Code 320 and are inspected and tested in accordance with the requirements of this Part. 1) Operators may elect to have their radiation machines and associated operating procedures inspected and tested by either a Departmental inspector or by a qualified nondepartment inspector whose name is included in the Department's record of persons approved as qualified inspectors of radiation machines. 2) Fees for Department inspection and testing will be as prescribed in the Act. AGENCY NOTE: The fee for a Department inspection and testing will be $45 per radiation machine located in dental offices and clinics and used solely for dental diagnosis, in veterinary offices and used solely for diagnosis, or in offices and clinics of persons licensed under the Podiatric Medical Practice Act of 1987 (Ill. Rev. Stat. 1989, ch. 111, par. 4801 et seq.), and used solely for diagnosis or therapy. The fee for inspection and testing in all other cases shall be $65 per radiation machine before January 1, 1990, and $80.00 per radiation machine on or after January 1, 1990. The Department will bill the operator for the appropriate fee after the machine has been inspected and tested. (See Section 8.9(a) of the Act.) 3) If the operator elects to have a qualified nondepartment inspector inspect and test the radiation equipment, the Department will assess a filing fee per radiation machine, as prescribed in Section 8.9(b) of the Act. The filing fee is payable, by the operator, to the Department upon submission of the qualified nondepartment inspector's radiation inspection report. AGENCY NOTE: The filing fee for radiation machine inspection and testing results is $5.00 per machine through December 31, 1989. Beginning January 1, 1990, the filing fee for inspection and testing results is $25.00 per machine. (See Section 8.9(b) of the Act.) b) Operators of radiation installations shall assure that all radiation machines located in that installation are maintained and operated in accordance with standards established by the Department to protect the public health and safety as set forth in 32 Ill. Adm. Code 310, 320, 340, 350, 360, 380, 390, 400, and 401. Operators shall also assure that all persons who use a radiation machine to administer ionizing radiation to human beings are licensed in accordance with the requirements of 32 Ill. Adm. Code 360.10 or are accredited by the Department or exempt from such requirements in accordance with 32 Ill. Adm. Code 401.30. c) Inspection Report Filing Anniversary Date (See Illustrations A and B for Anniversary Date Explanations) 1) Each operator of a radiation installation shall file an application for initial inspection and testing to be performed by either a Departmental inspector or a qualified nondepartment inspector no later than 30 days after the initial installation of a radiation machine(s) (See Section 8.9(c) of the Act) or 30 days after the effective date of this Part, whichever is later. The radiation machine(s) shall be inspected and tested in accordance with Section 410.50(a) and radiation inspection report(s) filed with the Department within 6 months of the date of initial installation or the effective date of this Part, whichever is later. The inspection and testing end date will establish the operator's filing anniversary date for filing subsequent radiation machine inspection reports. All future inspection and testing of the operator's radiation machine(s) must be performed and the radiation inspection report filed either on the filing anniversary date or within the 5 month period immediately preceding the operator's filing anniversary date. 2) For operators of radiation installations who have filed radiation inspection reports with the Department previous to the effective date of this Part, the filing anniversary date will be the end date of the last inspection and testing period as indicated on the most recent inspection report filed with the Department. All future inspection(s) and testing(s) of the operator's radiation machine(s) must be completed and the report filed either on the filing anniversary date or within the 5 month period immediately preceding the operator's filing anniversary date. 3) If any radiation machine(s) is installed, relocated (i.e., stationary equipment that has been moved) or reactivated within 7 months prior to the operator's inspection report filing anniversary date, and if the machine(s) is inspected during the 7 month period, the radiation machine(s) does not have to be reinspected within the 5 month period prescribed in subsection (c)(1). The radiation inspection report(s) shall be filed with the Department on or before the operator's inspection report filing anniversary date. 4) If any radiation machine(s) totally replaces the operator's radiation machine inventory, the operator's inspection report filing anniversary date will be changed to the end date of the inspection and testing of the radiation machine(s). In accordance with subsection (c)(1), inspection reports shall be filed within 6 months from the date of installation of the replacement machine(s). d) An operator shall file an application for subsequent inspections to be performed by either a Departmental or qualified nondepartment inspector in accordance with the following schedule: 1) Operators of Class A installations shall file an application for inspection each 3 years. 2) Operators of Class B installations shall file an application for inspection each 2 years. 3) Operators of Class C installations shall file an application for inspection annually. 4) Applications for inspections of existing radiation machines must be filed with the Department within 9 months of the operator's inspection report filing anniversary date. e) Within 30 days of the installation of new, used, relocated or reactivated radiation machines, the operator shall file an application for an inspection by either a Departmental inspector or a qualified nondepartment inspector. Inspection and testing of the radiation machine(s) shall be performed in accordance with subsection (c) above and radiation inspection report(s) filed with the Department within 6 months of the date of installation/activa- tion of the system(s). This Section applies to the relocation or reactivation of a radiation machine(s) that previously had been stored or rendered mechanically or electrically inoperable by the operator. (Source: Amended at 14 Ill. Reg. 13638, effective August 13, 1990) Section 410.70 Separate Installation Radiation Installations shall be defined as any location or facility where radiation machines are used. For purposes of registration and inspection frequency, the Department shall interpret "radiation installation" as follows: a) A radiation machine which is utilized by a given Class as defined in Section 410.40, is operated by the same person and is located in 1 building or in buildings which are contiguous to one another will be treated as a single radiation installation, except as provided in subsection (b) below. b) If the Department is treating radiation machines which are located in different buildings as being part of a single radiation installation in accordance with subsection (a) and the operator seeks to have the facilities treated as separate installations, the Department will consider the facilities as separate radiation installations upon receipt of a written request of the operator. (Source: Amended at 13 Ill. Reg. 342, effective January 30, 1989) Section 410.80 Change in Operator Within 30 days of changing the operator of a radiation installation, the new operator must notify the Department and must file an application for inspection by either a Departmental inspector or by a qualified nondepartment inspector. Such filing and inspection must be made regardless of the length of time which has passed since the most recent inspection of the radiation installation through the previous operator. (Source: Amended at 13 Ill. Reg. 342, effective January 30, 1989) Section 410.ILLUSTRATION A NEW FACILITY FILING ANNIVERSARY DATE (CLASS C FACILITY USED AS AN EXAMPLE) AGENCY NOTE: Letters set off by closed parenthesis in the above Illustration correspond to the arabic outline letters below. A) An operator of a "Class C" facility installs a radiation machine. (See Section 410.40(c).) B) Prior to operation, the operator must register the radiation machine with the Department. (See 32 Ill. Adm. Code 320.10.) C) The Department will forward an application for inspection to the operator upon notification of the installation of a radiation machine. The application will be the mechanism by which an operator will declare his or her preference for either a Department or qualified nondepartment inspector. (See Sections 410.60(a)(1) and (c)(1).) D) The operator is required to file the application for inspection within 30 days from the date of installation of the radiation machine. (See Section 410.60(c)(1).) E) The operator must have his or her radiation machine inspected and a radiation inspection report filed with the Department within 6 months of the date of initial installation. (See Section 410.60(c)(1).) F) The end date of the radiation machine inspection and testing will establish the operator's filing anniversary date for filing subsequent inspection reports. All future inspection and testing of the operator's radiation machine(s) must be performed and the radiation inspection report filed with the Department either on the filing anniversary date or within the 5 month period immediately preceding the filing anniversary date. (See Section 410.60(c)(1).) G) The operator is required to file an application with the Department for reinspection of his or her radiation machine within 9 months of the filing anniversary date. (See Section 410.60(d)(4).) H) The operator installs a new/used radiation machine or relocates/ reactivates an existing radiation machine that had been previously stored or rendered mechanically inoperable. I) The operator shall file an application with the Department for inspection within 30 days of the installation of new, used, relocated, or reactivated radiation machines. The inspection and testing of the radiation machine(s) shall be performed in accordance with Section 410.50(a) and radiation inspection report(s) filed with the Department within 6 months of the date of activation of the system(s). (See Section 410.60(e).) J) If any radiation machine(s) is installed, relocated or reactivated within 7 months prior to the operator's inspection report filing anniversary date, and if the machine(s) is inspected during the 7 month period, the radiation machine(s) does not have to be reinspected within the 5 month period prescribed in Section 410.60(c)(1). The radiation inspection report(s) shall be filed with the Department on or before the operator's inspection report filing anniversary date. (See Section 410.60(c)(3).) K) If any radiation machine(s) totally replaces the operator's radiation machine inventory, the operator's inspection report filing anniversary date will be changed to the end date of the inspection and testing of the radiation machine(s). In accordance with Section 410.60(c)(1), inspection reports shall be filed within 6 months from the date of installation of the replacement machine(s). (See Section 410.60(c)(4).) (Source: Added at 13 Ill. Reg. 342, effective January 30, 1989) Section 410.ILLUSTRATION B EXISTING FACILITY FILING ANNIVERSARY DATE (CLASS B FACILITY USED AS AN EXAMPLE) AGENCY NOTE: Letters set off by closed parenthesis in the above Illustration correspond to the arabic outline letters below. A) The effective date of Section 410.60(c). B) The end date of the operator's last radiation machine inspection and testing ("Class B" facility). C) The end date of the radiation machine inspection and testing will establish the operator's filing anniversary date for filing subsequent inspection reports. All future inspection and testing of the operator's radiation machine(s) must be performed and the radiation inspection report filed with the Department either on the filing anniversary date or within the 5 month period immediately preceding the filing anniversary date. (See Section 410.60(c)(2).) D) The operator is required to file an application with the Department for reinspection of his or her radiation machine within 9 months of the filing anniversary date. (See Section 410.60(d)(4).) E) The operator installs a new or used radiation machine or relocates or reactivates an existing radiation machine that had been previously stored or rendered mechanically inoperable. F) The operator shall file an application with the Department for inspection within 30 days of the installation of new, used, relocated, or reactivated radiation machines. The inspection and testing of the radiation machine(s) shall be performed in accordance with Section 410.50(a) and radiation inspection report(s) filed with the Department within 6 months of the date of activation of the system(s). (See Section 410.60(e).) G) If any radiation machine(s) is installed, relocated or reactivated within 7 months prior to the operator's inspection report filing anniversary date, and if the machine(s) is inspected during the 7 month period, the radiation machine(s) does not have to be reinspected within the 5 month period prescribed in Section 410.60(c)(1). The radiation inspection report(s) shall be filed with the Department on or before the operator's inspection report filing anniversary date. (See Section 410.60(c)(3).) H) If any radiation machine(s) totally replaces the operator's radiation machine inventory, the operator's inspection report filing anniversary date will be changed to the end date of the inspection and testing of the radiation machine(s). In accordance with Section 410.60(c)(1), inspection reports shall be filed within 6 months from the date of installation of the replacement machine(s). (See Section 410.60(c)(4).) (Source: Added at 13 Ill. Reg. 342, effective January 30, 1989)