Header:
CODE OF RHODE ISLAND RULES
AGENCY 14. DEPARTMENT OF HEALTH
SUB-AGENCY 120. OCCUPATIONAL AND RADIOLOGICAL HEALTH
CHAPTER 003. CONTROL OF RADIATION
Date:
08/31/2009
Document:
14 120 003. CONTROL OF RADIATION
…
A.5.7 Records of Individual Monitoring Results.
(a) Recordkeeping Requirement. Each licensee or registrant shall maintain records of doses received by all individuals for whom monitoring was required pursuant to A.3.3, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before 1 January 1994 need not be changed. These records shall include, when applicable:
(1) The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities; and
(2) The estimated intake of radionuclides [See A.2.4]; and
(3) The committed effective dose equivalent assigned to the intake of radionuclides; and
(4) The specific information used to assess the committed effective dose equivalent pursuant to A.2.6(a) and (c), and when required by A.3.3; and
(5) The total effective dose equivalent when required by A.2.4; and
(6) The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.
(b) Recordkeeping Frequency. The licensee or registrant shall make entries of the records specified in A.5.7(a) at intervals not to exceed 1 year.
(c) Recordkeeping Format. The licensee or registrant shall maintain the records specified in A.5.7(a) on Agency Form RCA-3, in accordance with the instructions for Agency Form RCA-3, or in clear and legible records containing all the information required by Agency Form RCA-3.
(d) The licensee or registrant shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, shall also be kept on file, but may be maintained separately from the dose records.
(e) The licensee or registrant shall retain each required form or record until the Agency terminates each pertinent license or registration requiring the record.
(f) Upon termination of the license or registration, the licensee or registrant shall make arrangements, satisfactory to the Agency, for permanent storage of records contained on Agency Form RCA-2 or equivalent.
…
A.7.3 Emergency Authority.
(a) Whenever the administrator finds that an emergency exists requiring immediate action to protect the public health or welfare, he may issue an order stating that an emergency exists and requiring that such action be taken as he deems necessary to meet the emergency. Such order shall be effective immediately.
(b) Any person to whom an emergency order is directed shall comply therewith immediately.
A.7.4 Orders of Suspension, Modification, and Revocation.
(a) An order may be issued for immediate suspension of a registration or license, or a portion thereof, as necessary to remove an immediate threat to the health or safety of a registrant's or licensee's employees or the public. Non-payment of fees beyond the due date may also result in the suspension of a registration or license.
(b) An order for the modification of a registration or license, in whole or in part, may be issued as an enforcement sanction, when it is determined that a registrant's or licensee's operations or activities must be limited or modified to protect the health, safety or interest of the registrant's or licensee's employees or the public.
(c) An order may be issued to revoke a registration or license when
(1) The registrant's or licensee's performance shows that he is not qualified to perform the activities covered by the registration or license; or
(2) The registrant or licensee refuses to correct violations; or
(3) A registrant or licensee does not comply with an Order of Abatement, or
(4) A registrant's or licensee's response to a Notice of Violation indicates inability or unwillingness to maintain compliance with regulatory requirements; or
(5) Any material false statement is made in the application or in any statement of fact required under these regulations.
…
C.5.3 Special Requirements for Issuance of Certain Specific Licenses for Radioactive Material.
(a) Human Use of Radioactive Material. In addition to the requirements set forth in C.5.2 and C.8, a specific license for human use of radioactive material in institutions will be issued under the following conditions:
(1) If the application is for medical use sited in a medical institution, only the institution's management may apply. If the application is for medical use not cited in a medical institution, any person may apply.
(2) The Agency finds the applicant equipped and committed to observe the safety standards established by the Agency in these regulations for the protection of the public health and safety.
(b) Human Use of Sealed Sources. In addition to the requirements set forth in C.5.2 and C.8, a specific license for human use of sealed sources will be issued only if the applicant or, if the application is made by an institution, the individual user is a physician.
(c) Use of Sealed Sources in Industrial Radiography. In addition to the requirements set forth in C.5.2, a specific license for use of sealed sources in industrial radiography will be issued if:
(1) The applicant submits an adequate program for training radiographers and radiographer's assistants that meets the requirements of E.2.10.
(2) The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid.
(3) The applicant submits written operating and emergency procedures as described in E.2.11.
(4) The applicant submits a description of a program for inspections of the job performance of each radiographer and radiographer's assistant at intervals not to exceed 6 months as described in E.2.10(e).
(5) The applicant submits a description of the applicant's overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegations of authority and responsibility.
(6) The applicant identifies and lists the qualifications of the individual(s) designated as the RSO (E.2.21) and potential designees responsible for ensuring that the licensee's radiation safety program is implemented in accordance with approved procedures.
(7) If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium (DU) shielding, the applicant must describe the procedures for performing the test. The description must include the:
(i) Instrumentation to be used;
(ii) Method(s) of collecting the samples;
(iii) Qualifications of the person who will analyze the wipe samples; and
(iv) Method(s) of analyzing the samples.
(8) If the applicant intends to perform "in-house" calibrations of survey instruments the applicant must describe methods to be used and the relevant experience of the person(s) who will perform the calibrations. All calibrations must be performed according to the procedures described and at the intervals prescribed in E.2.5.
(9) The applicant identifies and describes the location(s) of all field stations and permanent radiographic installations.
(10) The applicant identifies the location(s) where all records required by this subpart and other parts of these regulations will be maintained.
(11) If a license application includes underwater radiography, a description of:
(i) Radiation safety procedures and radiographer responsibilities unique to the performance of
underwater radiography;
(ii) Radiographic equipment and radiation safety equipment unique to underwater radiography; and
(iii) Methods for gas-tight encapsulation of equipment; and
(12) If an application includes offshore platform and/or lay-barge radiography, a description of:
(i) Transport procedures for radioactive material to be used in industrial radiographic operations;
(ii) Storage facilities for radioactive material; and
(iii) Methods for restricting access to radiation areas.
(d) Use of Radioactive Material at Property Not Owned by Applicant. In addition to the requirements set forth in C.5.2 and/or C.8, a specific license for use of radioactive material where the proposed location of use is not owned by the applicant will be issued under the following conditions:
(1) Each initial application shall include a letter signed by the property owner (or authorized representative) that permits the use of licensed radioactive material at the proposed location of use.
(2) Each amendment request for an additional location of use shall include a letter signed by the property owner (or authorized representative) that permits the use of licensed radioactive material at the proposed location of use.
…
C.5.17 Consideration of the Need for an Emergency Plan for Responding to a Release of Radioactive Materials.
(a) Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in Appendix F to this Part must contain either:
(1) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems to the thyroid; or
(2) An emergency plan for responding to a release of radioactive material.
(b) One or more of the following factors may be used to support an evaluation submitted under
(1) The radioactive material is physically separated so that only a portion could be involved in an accident;
(2) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;
(3) The release fraction in the respirable size range would be lower that the release fraction shown in Appendix F to this Part due to the chemical or physical form of the material;
(4) The solubility of the radioactive material would reduce the dose received;
(5) Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in Appendix F to this Part;
(6) Operating restrictions or procedures would prevent a release fraction as large as that shown in Appendix F to this Part;
(7) Other factors appropriate for the specific facility.
(c) An emergency plan for responding to a release of radioactive material submitted under C.5.17(a)(2) must include the following information:
(1) Facility Description. A brief description of the licensee's facility and area near the site.
(2) Types of Accidents. An identification of each type of radioactive materials accident for which protective actions may be needed.
(3) Classification of Accidents. A classification system for classifying accidents as alerts or site area emergencies.
(4) Detection of Accidents. Identification of the means of detecting each type of accident in a timely manner.
(5) Mitigation of Consequences. A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.
(6) Assessment of Releases. A brief description of the methods and equipment to assess releases of radioactive materials.
(7) Responsibilities. A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the Agency; also responsibilities for developing, maintaining, and updating the plan.
(8) Notification and Coordination. A commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of injured onsite workers when appropriate. A control point must be established. The notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the Agency immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency.[n44]
[n44 These reporting requirements do not supersede or release licensees of complying with the requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L. 99-499 or other state or federal reporting requirements.]
(9) Information to be Communicated. A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the Agency.
(10) Training. A brief description of the frequency, performance objectives and plans for training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios.
(11) Safe Shutdown. A brief description of the means of restoring the facility to a safe condition after an accident.
(12) Exercises. Provisions for conducting quarterly communications checks with the offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises although recommended is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.
(13) Hazardous Chemicals. A certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L. 99-499, if applicable to the applicant's activities at the proposed place of use of the radioactive material.
(d) The licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensee's emergency plan before submitting it to the Agency. The licensee shall provide any comments received within the 60 days to the Agency with the emergency plan.
Section C.6 Reciprocity.
C.6.1 Reciprocal Recognition of Licenses.
(a) Licenses of Radioactive Material.
(1) Subject to these regulations, and the limitations contained in C.6.1(a)(4), any person who holds a specific license from the U.S. Nuclear Regulatory Commission or any Agreement State, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this State, except for areas under exclusive federal jurisdiction, for a period not in excess of 180 days in any calendar year provided that:
(i) the licensing document does not limit the activity authorized by such document to specified installations or locations;
(ii) the out-of-state licensee submits Agency Form MAT-9, a copy of the pertinent licensing document, and the appropriate fee as prescribed in I.3.4 to the Agency at least three (3) days prior to engaging in such activity for the first time in a calendar year. If a submittal cannot be filed three (3) days before engaging in activities under reciprocity, because of an emergency or other reason, the Agency may waive the 3-day time requirement provided the licensee:
(a) Informs the Agency by telephone, facsimile, an Agency Form MAT-9, or a letter of initial activities or revisions to the information submitted on the initial Agency Form MAT-9;
(b) Receives oral or written authorization for the activity from the Agency; and
(c) Within three (3) days after the notification, files an Agency Form MAT-9, a copy of the pertinent licensing document, and the appropriate fee as prescribed in I.3.4.
(iii) the out-of-state licensee complies with all applicable regulations of the Agency and with all the terms and conditions of his licensing document, except any such terms and conditions which may be inconsistent with applicable regulations of the Agency;
(iv) the out-of-state licensee supplies such other information as the Agency may request; and
(v) the out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in C.6.1(a)(1) except by transfer to a person:
(a) specifically licensed by the Agency or by the U.S. Nuclear Regulatory Commission to receive such material, or
(b) exempt from the requirements for a license for such material under C.2.2(a).
(vi) the out-of-state licensee files an amended Agency Form MAT-9 with the Agency to request approval for changes in work locations, radioactive material, or work activities different from the information contained on the initial MAT-9.
(2) Notwithstanding the provisions of C.6.1(a)(1), any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State authorizing the holder to manufacture, transfer, install, or service a device described in C.4.2(b)(1) within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate or service such a device in this State, except for areas under exclusive federal jurisdiction, provided that:
(i) such person shall file a report with the Agency within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this State. Each such report shall identify each general licensee to whom such device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;
(ii) the device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the U.S. Nuclear Regulatory Commission or an Agreement State ;
(iii) such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that "Removal of this label is prohibited;" and
(iv) the holder of the specific license shall furnish to each general licensee to whom he transfers such device or on whose premises he installs such device a copy of the general license contained in C.4.2(b).
(3) The Agency may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by another agency, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.
(4) The Agency will not accept any applications for reciprocity under this subpart with respect to activities authorized pursuant to regulations that are equivalent to Subpart C.8 ["Use of Radionuclides in the Healing Arts"]. These activities will only be authorized under the provision of a specific license issued by the Agency.
(b) Licenses of Naturally-Occurring and Accelerator-Produced Radioactive Material.
(1) Subject to these regulations, and the limitations contained in C.6.1(b)(4), any person who holds a specific license from any Licensing State, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this State, except for areas under exclusive federal jurisdiction, for a period not in excess of 180 days in any calendar year provided that:
(i) the licensing document does not limit the activity authorized by such document to specified installations or locations;
(ii) the out-of-state licensee submits Agency Form MAT-9, a copy of the pertinent licensing document, and the appropriate fee as prescribed in I.3.4 to the Agency at least three (3) days prior to engaging in such activity for the first time in a calendar year. If a submittal cannot be filed three (3) days before engaging in activities under reciprocity, because of an emergency or other reason, the Agency may waive the 3-day time requirement provided the licensee:
(a) Informs the Agency by telephone, facsimile, an Agency Form MAT-9, or a letter of initial activities or revisions to the information submitted on the initial Agency Form MAT-9;
(b) Receives oral or written authorization for the activity from the Agency; and
(c) Within three (3) days after the notification, files an Agency Form MAT-9, a copy of the pertinent licensing document, and the appropriate fee as prescribed in I.3.4.
(iii) The out-of-state licensee complies with all applicable regulations of the Agency and with all the terms and conditions of his licensing document, except any such terms and conditions which may be inconsistent with applicable regulations of the Agency;
(iv) the out-of-state licensee supplies such other information as the Agency may request; and
(v) the out-of-state license shall not transfer or dispose of radioactive material possessed or used under the general license provided in C.6.1(b)(1) except by transfer to a person;
(a) specifically licensed by the Agency or by another Licensing State to receive such material, or
(b) exempt from the requirements for a license for such material under C.2.2.
(2) Notwithstanding the provisions of C.6.1(b)(1), any person who holds a specific license issued by a Licensing State authorizing the holder to manufacture, transfer, install, or service a device described in C.4.2(b)(1) within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate or service such a device in this State, except for areas under exclusive federal jurisdiction, provided that:
(i) such person shall file a report with the Agency within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this State. Each such report shall identify each general licensee to whom such device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;
(ii) the device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by a Licensing State ;
(iii) such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that "Removal of this label is prohibited;" and
(iv) the holder of the specific license shall furnish to each general licensee to whom he transfers such device or on whose premises he installs such device a copy of the general license contained in C.4.2(b).
(3) The Agency may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by a Licensing State, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.
(4) The Agency will not accept any applications for reciprocity under this subpart with respect to activities authorized pursuant to regulations that are equivalent to Subpart C.8 ["Use of Radionuclides in the Healing Arts"]. These activities will only be authorized under the provision of a specific license issued by the Agency.
(c) Generally Licensed Devices.
(1) Reciprocity requests involving generally licensed devices registered pursuant to C.4.2(b)(6) or the equivalent regulations of the U.S. Nuclear Regulatory Commission, another Agreement State or a Licensing State shall be handled in accordance with the procedures contained in C.6.1(a) or (b), as appropriate. Applicants for reciprocity shall submit evidence of current registration pursuant to C.4.2(b)(6) (or the equivalent regulations of the U.S. Nuclear Regulatory Commission, another Agreement State or a Licensing State) in lieu of a specific radioactive materials license.
(2) Reciprocity requests involving other generally licensed devices shall also be handled in accordance with the procedures contained in C.6.1(a) or (b), as appropriate. In lieu of a specific radioactive materials license, applicants for reciprocity shall submit a copy of the general license authorization for the device and documentation that they are authorized to possess the device under a general license pursuant to the regulations of the U.S. Nuclear Regulatory Commission, another Agreement State or a Licensing State that are applicable to the jurisdiction where the reciprocity request originated.
…
**Note: Only the section analyzed by the PHASYS team is included here as the entire regulation exceeded ~100 pages.
|