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 email@example.com or 571.298.1227 or Lynne Fairobent, Senior Manager of Government Relations at firstname.lastname@example.org or 571.298.1264.
Items of Interest
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 atintersocietal.org/iac/comment_period.htm#nuclear;
- Select the proposed Nuclear/PETStandardon which to comment;
- A window will expand with the description of theStandardand 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 theStandards. Facilities are notified of changes to the publishedStandards, and the most current version of theStandardscan 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: http://meetings.nrc.gov/pmns/
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.
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 at301-415-4132 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