To best represent medical physics, AAPM has worked to establish a close and cooperative working relationship with numerous government bodies and organizations including the Congress, federal and state agencies, related professional societies and a range of medical providers, corporations and suppliers.
The responsibility for ensuring the safe use of radioactive materials and radiation-producing machines is shared by a number of federal agencies and states. Key federal agencies are the Nuclear Regulatory Commission (NRC), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Environmental Protection Agency (EPA).
For additional information related to AAPM’s government relations efforts or if you have regulatory issues of concern, please contact Richard Martin, Government Relations Specialst at firstname.lastname@example.org or 571.298.1227 or Lynne Fairobent, Senior Manager of Government Relations at email@example.com or 571.298.1264.
Items of Interest
NRC Releases licensing guidance on Eckert and Ziegler GalliaPharmTM Germanium-68/Gallium-68 generator - updated October 6, 2016
On September 28, 2016, the U.S. Nuclear Regulatory Commission, in conjunction with the Agreement States through a joint working group, issued the enclosed licensing guidance entitled, “Eckert and Ziegler GalliaPharmTM Germanium-68/Gallium-68 Pharmacy Grade Generator Licensing Guidance.”
Germanium-68/Gallium-68 (Ge-68/Ga-68) generators are similar to conventional molybdenum-99/technetium-99m (Mo-99/Tc-99m) and strontium-82/rubidium-82 (Sr-82/Rb-82) generators, which are regulated under Title 10 of the Code of Federal Regulations (10 CFR) 35.200. Like Mo-99/Tc-99m and Sr-82/Rb-82 generators, potential breakthrough of the parent radionuclide is possible when eluting the generator. This breakthrough could lead to Ge-68 contaminating the Ga-68 radiopharmaceutical, potentially causing an unnecessarily higher radiation exposure to patients. 10 CFR 35.204 provides permissible concentration limits for parent radionuclides for Mo-99/Tc-99m and Sr-82/Rb-82 generators to limit such exposure, but no such limit is specified for Ge-68/Ga-68 generators. Therefore, the use of a Ge-68/Ga-68 generator to prepare Ga-68 radiopharmaceuticals for imaging and localization studies is regulated under 10 CFR 35.1000, "Other Medical Uses of Byproduct Material or Radiation from Byproduct Material."
This licensing guidance applies only to the use of the GalliaPharmTM Ge-68/Ga-68 pharmaceutical grade generator manufactured by Eckert and Ziegler Radiopharma GmbH. All sections of this licensing guidance apply to both medical licensee and commercial nuclear pharmacy licensee use of this generator, unless otherwise specified. This licensing guidance does not apply to licensees or applicants that will receive unit or bulk doses of Ga-68 radiopharmaceuticals rather than use the Eckert and Ziegler GalliaPharmTM generator themselves. These licensees and applicants will be regulated under 10 CFR 35.200 and, as such, authorized users must meet the requirements in 10 CFR 35.290.
This licensing guidance may also be found on the NRC Medical Uses Licensee Toolkit. If you have any questions regarding this correspondence, please contact Dr. Katie Tapp at 301-415-0236 or Katherine.Tapp@nrc.gov.
IAC Releases Updates to Nuclear/PET Standards -New Standards Effective March 15, 2017 –updated September 15, 2016.
As an accreditation organization, IAC Nuclear/PET is committed to maintaining a program that balances the changing needs of both the nuclear cardiology, nuclear medicine and PET community and the general public by influencing the quality of patient care provided. The IAC Standards and Guidelines for Nuclear/PET Accreditation are the most important component of that commitment. Composed by physicians and technologists from the IAC sponsoring organizations, the Standards are reviewed periodically by the Board of Directors and revised as needed. As a component of the accreditation process, the IAC Nuclear/PET Board of Directors preliminarily approved the proposed Standards which were posted to the IAC Nuclear/PET website for a 60-day public comment period from April 1 to June 1, 2016. Following careful review and consideration of the comments received, the Board of Directors voted final approval of the Standards.
Key Revisions to the IAC Standards for Nuclear/PETSome of the changes made are a clarification or explanation of the previous Standards, however, in several instances, the requirements have been modified. Key modifications include:
- Technical Staff - The Standard previously titled nuclear medicine technologist(s) is now technical staff in all references.
- General Protocol Guidelines - A substantial change to the IAC Nuclear/PET Standards regarding the required administered radiopharmaceutical dose ranges and corresponding radiation effective doses for myocardial perfusion imaging was made. To read the background on this change, please visit intersocietal.org/nuclear/main/dose.htm.
- Part D: Therapy Procedures - The majority of the new Part D section already existed in the previous Standards, however, these requirements were moved to a new section for Therapy Protocols and Performance only.
For a summary of all the revisions made to the Nuclear/PET Standards, please visit intersocietal.org/nuclear/standards/IACNuclearPETStandards2016_SummaryofChanges.pdf.
WA Proposed Rule for Computed Tomography (CT) - update September 6, 2016
The State of Washington has published a proposed rule for CT. Comments will be accepted through September 7, 2016. These changes do not apply to registrants exclusively using low power CT X-ray systems (5 kW or less) or cone-beam CT X-ray systems or CT simulators exclusively for treatment planning purposes in conjunction with a megavoltage radiation therapy or brachytherapy.
A Public Hearing will be held September 7, 2016, 10:00 a.m.
Washington State Department of Health
Town Center 3, Room 224
111 Israel Road Southeast
Tumwater, Washington 98504
The WA Department of Health worked with an advisory committee to develop rules for the safe use of CT X-ray systems for diagnostic purposes. The use of CT X-ray systems has grown in recent years in number of units, frequency of prescribed scans and, most importantly, the amount of radiation used. The proposed rules are intended to reduce occupational and patient radiation exposure, and help prevent overexposure. If you have questions about this rulemaking, contact Dan Van Gent, X-Ray Section Manager, at 360-236-3231.
- Preliminary Significant Analysis (PDF)
- Preliminary Small Business Economic Impact Statement (PDF)
- CR-101 Preproposal Statement of Inquiry (PDF)
- CT Advisory Committee
MN Announces Intent to revise x-ray regulations - updated August 18, 2016
The State of Minnesota has announced their intent to revise the state's x-ray regulations. Attached for your information is the announcement from the July 18th State Federal Register and the excerpted relevant text. The state is requesting comments by September 17, 2016 on what the proposed rule should look like.
The latest version of the Council of Radiation Control Program Directors (CRCPD's) Suggested State Regulation - Part F and the rationale which were revised in 2015. SSR-F may give you some insight as to what x-ray regulations should look like.
Questions should be directed to Richard Martin, Government Relations Specialist at firstname.lastname@example.org or 571.298.1227 or Lynne Fairobent, Senior Manager of Government Relations at email@example.com or 571.298.1264.
Department of Veterans Affairs Issued Advanced Practice Nurses Proposed Rule - update June 21, 2016
The Department of Veterans Affairs(VA) is seeking comments on a proposed rule that would amend its medical regulations to permit full practice authority of all VA advanced practice registered nurses (APRNs) when they are acting within the scope of their VA employment. Purpose is to increase veterans' access to VA health care by expanding the pool of qualified health care professionals who are authorized to provide primary health care and other related health services consistent with their education, training and certification. If passed, the APRN may practice without the clinical supervision or mandatory collaboration of physicians. This will also take precedence over state regulations. In the proposed rule, the VA stated that this would help to ensure a consistent continuum of health care across Veterans Health Administration by decreasing the variability in APRN practice that currently exits due to variability of state practice regulations.
AAPM represents diagnostic medical physicists who work side-by- side with both radiologic technologists and radiologists; medical physicists are involved in training both groups, and in optimizing protocols which impact both the acquisition and interpretation of medical imaging. Medical physicists have no financial stake in the VA proposal, and this commentary represents our significant experience working in the diagnostic radiology environment and our commitment to patient safety. Based upon the experience of medical physicists, there is absolutely no possibility that our respected advanced practice registered nurse colleagues, who lack the experience of radiologic technologists for acquisition and radiologists for interpretation of medical images, could deliver accurate radiologic diagnostic images and interpretation. Allowing this proposal to go forward would produce substandard care and be an egregious disservice to veterans who have honorably served our nation.
If you have questions please contact Lynne Fairobent, Senior Manager of Government Relations at firstname.lastname@example.org.
The U.S. Nuclear Regulatory Commission (NRC) has revised and consolidated two policy statements on NRC’s Agreement State Programs: the ‘‘Policy Statement on Adequacy and Compatibility of Agreement State Programs’’ and the ‘‘Statement of Principles and Policy for the Agreement State Program.’’ The resulting proposed single policy statement has been revised to add that public health and safety includes physical protection of agreement material. Comments must be submitted to NRC by August 16, 2016.
The Commission’s proposed consolidated policy removes details on the Integrated Materials Performance Evaluation Program (IMPEP) and the ‘‘Principles of Good Regulation.’’ The NRC added a description of the National Materials Program (NMP).
Of note is the change to the definition of Levels of Compatibility especially Compatibility Category B. Based on comments received, the NRC staff noted that there is a wide variation on the interpretation of the description of Compatibility Category B and of the definition of significant transboundary implication. In light of this, the Commission is proposing a new description of Compatibility Category B to eliminate the phrase ‘‘significant transboundary implication.’’
NRC stated that:
- “An ‘‘adequate’’ program includes those program elements of a radiation control regulatory program necessary to maintain an acceptable level of protection of public health and safety within an Agreement State. An Agreement State’s radiation control program is adequate to protect public health and safety if administration of the program provides reasonable assurance of protection of public health and safety in regulating the use of agreement material. The level of protection afforded by the program elements of the NRC’s materials regulatory program is presumed to be adequate to provide a reasonable assurance of protection of public health and safety. Therefore, the overall level of protection of public health and safety provided by a State program should be equivalent to, or greater than, the level provided by the NRC program.”
- “A ‘‘compatible’’ program consists of those program elements necessary to sustain an orderly pattern of regulation of radiation protection. An Agreement State has the flexibility to adopt and implement program elements within the State’s jurisdiction that are not addressed by the NRC, or program elements not required for compatibility (i.e., those NRC program elements not assigned to Compatibility Category A, B, or C). However, such program elements of an Agreement State relating to agreement material shall (1) be compatible with those of the NRC (i.e., should not create conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis); (2) not preclude a practice authorized by the AEA and in the national interest; and (3) not preclude the ability of the Commission to evaluate the effectiveness of the NRC and Agreement State programs for agreement material with respect to protection of public health and safety. For purposes of compatibility, the State shall adopt program elements assigned Compatibility Categories A, B, and C.”
“The proposed new definition of levels of compatibility are:
- Category A—Basic Radiation Protection Standards. This category includes basic radiation protection standards that encompass dose limits, concentration and release limits related to radiation protection in part 20 of title 10 of the Code of Federal Regulations (10 CFR), that are generally applicable, and the dose limits for land disposal of radioactive waste in 10 CFR 61.41.7 Also included in this category are a limited number of definitions, signs, labels, and scientific terms that are necessary for a common understanding of radiation protection principles among licensees, regulatory agencies, and members of the public. Such State standards should be essentially identical to those of the NRC, unless Federal statutes provide the State authority to adopt different standards. Basic radiation protection standards do not include constraints or other limits below the level associated with ‘‘adequate protection’’ that take into account considerations such as economic cost and other factors.
- Category B—Cross Jurisdictional Program Elements. This category pertains to a small number of program elements that cross jurisdictional boundaries and that should be addressed to ensure uniformity of regulation on a nationwide basis. Examples include, but are not limited to, sealed source and device registration certificates, transportation regulations, and radiography certification. Agreement State program elements shall be essentially identical to those of the NRC. Because program elements used in the Agreement State Program are necessary to maintain an acceptable level of protection of public health and safety, economic factors 8 should not be considered.
- Category C—Other NRC Program Elements. These are other NRC program elements that are important for an Agreement State to implement in order to avoid conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis. Such Agreement State program elements should embody the essential objective of the corresponding NRC program elements. Agreement State program elements may be more restrictive than NRC program elements; however, they should not be so restrictive as to prohibit a practice authorized by the AEA and in the national interest without an adequate public health and safety or environmental basis related to radiation protection.
- Category D—Program Elements Not Required for Compatibility. These are program elements that do not meet any of the criteria listed in Compatibility Category A, B, or C above and are not required to be adopted for purposes of compatibility.
- Category NRC—Areas of Exclusive NRC Regulatory Authority. These are program elements over which the NRC cannot discontinue its regulatory authority pursuant to the AEA or provisions of title 10 of the Code of Federal Regulations. However, an Agreement State may inform its licensees of these NRC requirements through an appropriate mechanism under the State’s administrative procedure laws as long as the State adopts these provisions solely for the purposes of notification, and does not exercise any regulatory authority as a result.”
Individual comments may be submitted to NRC by August 16, 2016 by any of the following methods:
- Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC–2016–0094.
- Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: OWFN 12–H08, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001.
If you would like AAPM to consider any comments on this draft policy statement, please email them to Richard Martin, Government Relations Specialist at email@example.com or Lynne Fairobent, Senior Manager for Government Relations as firstname.lastname@example.org no later than August 1, 2016 in order that the comments can be consolidated and approved for submittal to NRC by August 16, 2016.
New Version of DICOM Standard Available - Replaces the 2016b release.
- The 2016c release of the DICOM standard is now available from the DICOM home page or from dicom.nema.org/medical/dicom/current/. It is also indexed from Editor’s status page at: www.dclunie.com/dicom-status/status.html
- Release notes are at: dicom.nema.org/medical/dicom/current/output/pdf/releasenotes_2016c.pdf
- The changes from the 2016b release are shown highlighted in PDF files; note that changes to figures are not detected and some changed figures are not rendered in the diff files: www.dclunie.com/dicom-status/status.html#DiffsStandard2016b2016c .
IAEA Publishes Nuclear Medicine Handbook - updated June 13, 2016
The International Atomic Energy Agency (IAEA) recently published theNuclear Medicine Physics Handbook. The handbook, intended for teachers, students and residents involved in medical physics programs, provides a comprehensive overview of the knowledge required in physics, instrumentation and data processing for the practice of medical physics in modern nuclear medicine. A set of teaching slides were also developed to assist in presenting the material in each chapter. You can download a PDF version of the slides or register with the IAEA to obtain the Power Point version.
In addition, the IAEA has made available the IAEA Radiotracer Biodistribution Template (IAEA-RaBiT)– a free resource for (organ level) radionuclide dosimetry research and applications for those involved with internal dosimetry. The IAEA-RaBiT is a standard-format template that can be used to organize biodistribution information within a center, reporting it in publications, and support high throughput dosimetry protocols. It is freely available for download/use, created as a community resource.Finally, for those interested in Quality Assurance and Quality Controls of SPECT systems, IAEA has also developed an e-learning module for SPECT systemsand tutorial videoson the IAEAHuman Health Campus.
The National Electrical Manufacturers Association (NEMA) published NEMA XR 31-2016 Standard Attributes on X-ray Equipment for Interventional Procedures. The Medical Imaging and Technology Alliance (MITA), a division of NEMA, developed this new standard using MITA Smart Dose Interventional technology. This standard offers healthcare providers a reference to identify key features which contribute to enhanced patient care and to help manage patient radiation dose delivery, while still enabling the system to provide sufficient image quality needed by the physician.
NEMA XR 31-2016 Standard Attributes on X-ray Equipment for Interventional Procedures describes eight features that should be taken into consideration when performing risk management evaluations on existing stationary x-ray interventional equipment. These key features were introduced over the course of the past decade and are now considered state of the art: dosimetric indications
- added filters
- range of air kerma rates in fluoroscopy
- virtual collimation
- stored fluoroscopy
- variable pulsed fluoroscopy
- digital x-ray imaging device
Proposed Changes to IAC Nuclear/PET Standards - Now Open for Public Comment - updated April 1, 2016
The Intersocietal Accreditation Commission (IAC) has announced a substantial change to the IAC Nuclear/PET Standards regarding the required radiopharmaceutical activities and their corresponding radiation effective doses is proposed.Details on the changes can be found at: intersocietal.org/nuclear/main/dose.htm. Comment period closes June 1st, 2016. In order to provide comments, the IAC Comment Form must be completed and submitted electronically by the provided deadline.
The Standards are reviewed periodically by the IAC Nuclear/PET Board of Directors and revised as needed. As a component to the accreditation process, proposed Standards that have been approved by the Board of Directors are then posted to the IAC website for a 60-day public comment period. These proposed Standards include changes to the current Standards, the removal of current Standards and/or the addition of new Standards.
To Submit a Comment on ProposedStandards
- Visit the IAC website at intersocietal.org/iac/comment_period.htm#nuclear;
- Select the proposed Nuclear/PET Standard on which to comment;
- A window will expand with the description of the Standard and the proposed change on the left;
- On the right, fill in your name and comment in the boxes provided;
- Hit Submit.
At the close of the comment period, the IAC Nuclear/PET Board of Directors will review any submitted comments, consider modifications as needed and vote for final approval of the Standards. Facilities are notified of changes to the published Standards, and the most current version of the Standards can be viewed or printed from the IAC Nuclear/PET website at intersocietal.org/nuclear/main/nuclear_standards.htm.
If you have questions or comments that you would like AAPM to consider submitting, please contact Lynne Fairobent, Senior Manager of Government Relations at email@example.com.
AAPM Submits Comments to the Joint Commission in response to the Proposed New National Patient Safety Goal on Pediatric Computed Tomography (CT) Imaging
The Joint Commission was seeking input on a proposed new National Patient Safety Goal (NPSG) on Pediatric Computed Tomography (CT) Imaging. Published data about the frequency of pediatric CT imaging varies. Despite evidence that use of CT may have stabilized or is declining after a period of increased use, there is an opportunity to further prevent unnecessary radiation exposure for children. An NPSG would spotlight this issue, and would motivate accredited organizations to use evidence-based practices for determining when CT examinations are necessary.
NRC Program Review of 10 CFR Part 37 - Updated March 28, 2016
The NRC has initiated a program review of requirements in 10 CFR Part 37 to evaluate the clarity of the rule language and licensee experience with implementing the rule. As part of this review, the NRC sought input from various stakeholders, including licensees. Several licensees provided voluntary assistance by completing a questionnaire about Part 37 regulatory requirements and guidance, as well as participated in interview sessions as follow-up to the questionnaires.
As part of the continuing program review, the NRC has issued a Federal Register Notice (FRN) on March 14, 2016, and plans to hold a series of public meetings to discuss the topics identified in the FRN and facilitate public participation in the Part 37 assessment that is being performed by the NRC.
The staff will publicly notice the official dates and times of these meetings, but they are tentatively scheduled as webinars on March 31, April 7, April 12, and April 19, and a public meeting to be held at the NRC Headquarters on May 5, 2016. The webinars will be focused on specific audiences – e.g., March 31 and April 7 – Materials Licensees; April 12 – Agreement States; and April 19 – Reactor or Part 50 Licensees. The American Association of Physicists in Medicine is welcome to participate in any meeting that suits its availability. Please consult the NRC public meeting schedule, which can be accessed at: meetings.nrc.gov/pmns/mtg.
Please find the direct link below to register for Webinar 1:
Webinar 1 – Program Review of Part 37 of Title 10 of the Code of Federal Regulations
Join us for a webinar on Mar 31, 2016 at 2:00 PM EDT. Register now!
After registering, you will receive a confirmation email containing information about joining the webinar.
Comments on the FRN are due by May 13, 2016. Please feel free to send any written comments on the FRN or any other comments or items you would like to share, to Part37Assessment@nrc.gov. If you have any questions about the webinars and public meeting or any other questions, please feel free to call George Smith at 301-415-7201 or email George.firstname.lastname@example.org; or Carrie Crawford at 301-415-4132< or email email@example.com.
The Intersocietal Accreditation Commissionl (IAC) releases A Year in Review - updated March 22, 2016
For the first time in its 25 year history, the IAC has published a review of its history.
MITA sends letter to CMS re: XR-29 - updated March 21, 2016
The Medical Imaging and Technology Alliance (MITA) sent a letter to the Centers for Medicare & Medicaid Services (CMS) on January 20, 2016 with questions on the process that CMS will use to determine compliance. On March 4, 2016, CMS responded to MITA's questions.
FDA Approves ACR's Digital Mammography Manual - updated March 11, 2106
This alternative standard was approved and became effective on February 17, 2016. It has no time limit. The alternative standard allows for the use by mammography facilities of the ACR Digital Mammography Quality Control Manualas an alternative to the quality assurance program recommended by the image receptor manufacturer. The FDA has determined that the ACR's quality control manual is, as required in § 900.18(a)(1): Alternative Requirements, “at least as effective in assuring quality mammography” as following the manufacturers’ QC manuals. For the most recent FDA assistance, please visit Frequently Asked Questions about DBT and MQSA Training Requirements. If there are additional questions, contact the FDA Mammography Facility Hotline at 1-800-838-7715 orMQSAhotline@hcmsllc.com.
NOTE from ACR: The ACR manual is currently undergoing preparation for publication and should be available this spring. ACR-accredited mammography facilities and those applying for accreditation will be invited to download the PDF manual at no charge; medical physicists associated with ACR-accredited facilities will also be allowed to download the manual at no charge.
NRC Issues Update to Yttrium-90 Microspheres Licensing Guidance added March 1, 2016
On February 17, 2016, the U.S. Nuclear Regulatory Commission (NRC), in conjunction with the Agreement States through a joint working group, issued revision 9 to the licensing guidance for Yttrium-90 (Y-90) Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres®.
The licensing guidance for Y-90 microsphere brachytherapy was initially published in October 2002 and subsequently revised in 2004, 2007, 2008, 2011, and 2012. Based on recommendations from the Advisory Committee on the Medical Uses of Isotopes (ACMUI) (ADAMS Accession No.ML14300A138), the joint working group revised this licensing guidance. This current licensing guidance revision has three major changes based on these ACMUI recommendations.These changes (1) remove specifications for gastrointestinal tract and lung dose/activity in the written directive and exclude reporting dose/activity to an organ or tissue other than the treatment site as a medical event when the dose/activity is caused by shunting when the shunting was evaluated prior to treatment in accordance with manufacturer’s procedures, (2) specifically exclude reporting of events due to stasis or emergent patient conditions, and (3) allow for interventional radiologists certified by the American Osteopathic Board of Radiology to become Authorized Users.The licensing guidance may also be found on the NRC Medical Uses Licensee Toolkit at www.nrc.gov/materials/miau/med-use-toolkit.html#et.
If you have questions regarding the Y-90 Licensing Guidance, please contact Katie Tapp at (301) 415-0236 or Katherine.Tapp@nrc.gov.
If you have questions about the ACMUI meeting notice, please contact Sophie Holiday at (301) 415-7865 or Sophie.Holiday@nrc.gov.
NRC Updates Medical Uses Licensee Toolkit - added February 2016
NRC recently updated the Medical Uses Licensee Toolkit to include the Purpose of Medical Event Reporting. Immediately beneath this section, you will find the Medical Event Presentations from the 2015 Advisory Committee on Medical Uses of Isotopes (ACMUI) Meetings. Additional presentations will be posted when available. If you have any questions related to the “Purpose of Medical Event Reporting”, please contact Said.Daibes@nrc.gov. If you have any questions related to the “Medical Event Presentations”, please contact Sophie.Holiday@nrc.gov.
Draft ICRP report “Diagnostic Reference Levels in Medical Imaging Available for Comment - added February 2016
The International Commission on Radiological Protection (ICRP) first introduced the term ‘diagnostic reference level’ (DRL) in Publication 73 (1996). The concept was subsequently developed further, and practical guidance was provided in 2001. DRLs have been proven to be an effective tool that aids in optimization of protection in the medical exposure of patients for diagnostic and interventional procedures. However, with time it has become evident that additional advice is needed. There are issues related to definitions of the terms used in previous guidance, determination of the values for DRLs, the appropriate interval for re-evaluating and updating these values, appropriate use of DRLs in clinical practice, methods for practical application of this tool, and application of the DRL concept to newer imaging technologies. This report is intended as a further source of information and guidance on these issues. Some terminology has been clarified. In addition, the report recommends quantities for use as DRLs for various imaging modalities, and provides information on use of DRLs for interventional procedures and in pediatric imaging. It suggests modifications in the conduct of DRL surveys that take advantage of automated reporting of radiation dose related quantities, and points out the importance of including information on DRLs in training programs for health care workers. The target audience for this report is national, regional and local authorities, professional societies, facilities where ionizing radiation is used for medical purposes, and responsible staff within these facilities. A full set of the Commission’s recommendations is provided.
Please send your comments to Lynne Fairobent at firstname.lastname@example.org on the attached Excel spreadsheet no later than April 1st, so that they can be consolidated as AAPM comments. Please be sure to include page and line number as the ICRP did not do continuous line numbering.
NCRP Requests Comments on Draft Lens of the Eye Commentary
The draft NCRP commentary prepared by SC 1-23 on “Guidance on Radiation Dose Limits for the Lens of the Eye” is now ready for review.This Commentary has been prepared in order to provide guidance on whether existing 3 dose limits to the lens of the eye should be changed in the United States. The guidance is based on a detailed evaluation of recent studies on the radiation dose response for the development of 5 cataracts.
Please focus your comments on substantive (e.g., technical errors, references that are not included and incomplete or incorrect interpretation of data) rather than editorial problems in the draft commentary. If you have suggestions for changes or additions to the text, please indicate clearly how your recommendations should be addressed by the committee in preparing the final revision of the commentary.
If you would like to have AAPM consider your comments, please send your comments to Lynne Fairobent at email@example.com on the attached excel spreadsheet by March 1st in order that I can consolidate them for AAPM's submittal. NCRP comment period closes March 9th.
NRC Requests for Information Regarding I-131 Patient Release.
The NRC is interested in obtaining input from as many stakeholders as possible, including the physicians, the NRC and Agreement State medical use licensees, and NRC MML medical use permittees that administer I-131 under the provisions of Title 10 of the Code of Federal Regulations Part 35 (10 CFR 35.300) or equivalent Agreement State requirements. The NRC is also interested in obtaining input from Agreement States. In addition to the recipients of this RIS, the NRC will also be seeking input from patients, patient advocacy groups, professional organizations, and other interested individuals. The focus of this information-gathering effort is to obtain: information that patients believe will help them understand the I-131 (also referred to as Radioactive Iodine (RAI)) treatment procedures, the physician’s or licensee’s/permittee’s best practices when making informed decisions on releasing RAI treatment patients, and information provided to patients on how to reduce radiation doses to others. The NRC is also interested in learning if patient advocacy groups, medical professional organizations, licensees, or other individuals have brochures that already contain the information requested.
The NRC published the “Sodium Iodide I-131 Patient Release Information Collection” FRN to reach as many stakeholders as possible. In the FRN, the NRC staff requested that stakeholders provide the NRC with information that they already possess concerning: (1) Web sites that provide potential patients with information on RAI treatment procedures so that patients will understand the reason for the procedures, the process, and how to reduce radiation exposure to others; (2) patient/licensee acknowledgement forms and best practices that focus on the dialog used by physicians/licensees and patients that ultimately results in the informed decision, based on radiation exposure considerations, on when the patient should be released; (3) guidance for released patients that helps to reduce the variability of instructions provided to patients and to eliminate some of the uncertainty regarding the type of information that is provided to the patient; and (4) an existing brochure for nationwide use that licensees and Agreement States believe provides clear guidance on the release of patients treated with I-131.
To aid all stakeholders, in the FRN NRC staff provided suggested topics or questions related to the information the stakeholders will submit on the Web site, in the patient/licensee acknowledgement forms, in guidance for released patients, and in a brochure for nationwide use. Because these topics and questions are probably incomplete, the NRC staff also requested that stakeholders, based on their personnel experience, identify any additional topics and questions that they believe should be included in these lists and any that they believe should be omitted from these lists. The NRC is not requesting the development of new information or that individuals research any of the topics presented in the FRN. Greater detail on the information requested and how to submit it is provided in the FRN. The NRC is also requesting that Agreement State and NRC medical use licensees, as well as NRC MML medical use permittees, voluntarily share the FRN with their staff associated with the administration of sodium iodine I-131. As noted in the FRN, this information should be submitted by February 16, 2016. The FRN is enclosed or can be accessed on the electronic Federal Register page.
AAPM submitted comments in response to the above request.
NRC Requests Comments on Petitions to change basis of Radiation Protection Regulations
On June 23, 2015, NRC published in the Federal Register, (link: federalregister.gov/a/2015-15441) a request for comment on three petitions from Drs. Carol Marcus, Mark L. Miller, and Mohan Doss for rulemaking (PRM) (Docket Nos.: PRM-20-28, PRM-20-29, PRM-20-30) requesting that NRC amend its “Standards for Protection Against Radiation” regulations and change the basis of those regulations from the Linear No-Threshold model of radiation protection to the radiation hormesis model. See the attached file for the Notice titled, ‘‘Linear No-Threshold Model and Standards for Protection Against Radiation.”
Full details of the Petitions can be accessed at: www.regulations.gov/#!docketDetail;D=NRC-2015-0057.
Comments specific to the Petitions for Rulemaking should be submitted by September 08, 2015. Comments received after these dates will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date. If you have any comments that AAPM should consider in a response, please send them to Lynne Fairobent, Senior Manager for Government Relations at firstname.lastname@example.org no later than August 25, 2015.
In keeping with the IAC's continued commitment to streamlining and simplifying the accreditation process, we are pleased to announce that the public now has the opportunity to comment on proposed changes to the IAC Standards and Guidelines for MRI Accreditation.
The Standards are reviewed periodically by the IAC MRI Board of Directors and revised as needed. As a new component to the accreditation process, proposed Standards that have been approved by the Board of Directors are then posted to the IAC website for a 60-day public comment period. These proposed Standards include changes to the current Standards, the removal of current Standards and/or the addition of new Standards.
Beginning May 5th, 2015, the public may visit the IAC website at intersocietal.org/iac/comment_period.htm to comment on any of the proposed Standards until July 5th, 2015.
In order to provide comments, the IAC Comment Form must be completed and submitted electronically by the provided deadline.
To Submit a Comment on Proposed Standards:
- Visit the IAC website at intersocietal.org/iac/comment_period.htm;
- Scroll down to the section for MRI Standards Available for Comment;
- Select the proposed Standard on which to comment;
- A window will expand with the description of the Standard and the proposed change on the left;
- On the right, fill in your name and comment in the boxes provided;
- Hit Submit.
- At the close of the comment period, the IAC MRI Board of Directors will review any submitted comments, consider modifications as needed and vote for final approval of the Standards. Facilities are notified of changes to the published Standards, and the most current version of the Standards can be viewed or printed from the IAC MRI website at intersocietal.org/mri/main/mri_standards.htm.
On November 20, 2014,NRC published in theFederal Register,an extension for the comment period for advance notice of the 10 CFR Part 20 proposed rulemaking by 120 days. Comments should be filed no later than June 22, 2015 (80 FR 14033).
NRC issued the Advance Notice for Proposed Rulemaking (ANPR) for 10 CFR Part 20 Standards for Protection Against Radiation was published in the Federal Register on July 25, 2014 (79 FR 43284). In addition to the ANPR, NRC also published 6 Issue Papers as well. This information is contained on the NRC website:
- Advance Notice of Proposed Rulemaking: Potential Changes to Radiation Protection Regulations
- Issue Paper 1: Update 10 CFR Part 20 to Align with International Commission on Radiological Protection Publication 103 Methodology and Terminology.
- Issue Paper 2: Occupational Dose Limit for the Lens of the Eye.
- Issue Paper 3: Dose Limit for the Embryo/Fetus of a Declared Pregnant Occupational Worker.
- Issue Paper 4: Individual Protection - ALARA Planning.
- Issue Paper 5: Metrication - Units of Radiation Exposure and Dose.
- Issue Paper 6: Reporting of Occupational Exposure.
Additional background information on NRC's Options to Revise Radiation Protection Regulations and Guidance can be found here.
Please send any comments for AAPM’s consideration to Lynne Fairobent, Senior Manager for Government Relations at email@example.com.
- 2016-03-31 - AAPM Comments to The Joint Commission Proposed New National Patient Safety Goal on Pediatric Computed Tomography (CT) Imaging
- 2016-08-26 - AAPM Comments to NRC re: Docket Nos: PRM-20-28, PRM-20-29 and PRM-20-30 (80 FR 35870)
- 2016-02-16 - AAPM comments to NRC re: patient release
- Comments filed by AAPM between 2006 – 2010