To best represent medical physics, the 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.
For additional information related to AAPM’s government relations efforts, contact Lynne Fairobent, manager of Legislative and Regulatory Affairs at lynne@aapm.org or 301-209-3364.
NRC Issues Regulatory Guide 8.35 Revision 1: Planned Special Exposures (75FR52999) Regulatory Guide 8.35 provides guidance on the conditions and prerequisites for permitting planned special exposure(s) (PSE(s)), as allowed by Title 10 of the Code of Federal Regulations (10 CFR) Part 20, “Standards for Protection against Radiation” (Ref. 1), the associated specific monitoring and reporting requirements, and examples of acceptable means of satisfying these requirements. This was issued with a temporary identification as Draft Regulatory Guide, DG–8032. The full text of Regulatory Guide 8.35 Revision 1 can be found at: http://www.nrc.gov/reading-rm/doc-collections/reg-guides/occupational-health/rg/.
NRC Notice of issuance and availability of Draft Regulatory Guide, DG–8035, ‘‘Administrative Practices in Radiation Surveys and Monitoring. ’’ (75FR52996)
On August 30, 2010, NRC announced the availability of Draft Regulatory Guide DG-8035. DG–8035 is proposed Revision 1 of Regulatory Guide 8.2, dated August 1973. This guide provides general guidance that the staff of the NRC considers acceptable for the administrative practices associated with surveys and monitoring of ionizing radiation in licensed institutions, intended primarily for administrative and management personnel in organizations that are involved in, or are planning to initiate, activities involving the handling of radioactive materials or radiation.
The administrative requirements for radiation monitoring are mainly specified in Title 10 of the Code of Federal Regulations, part 20, ‘‘Standards for Protection against Radiation’’ (10 CFR part 20), and are applicable to all NRC-licensed activities. This part requires surveys in order to evaluate the significance of radiation levels that may be present. In addition, it requires radiation monitoring in order to obtain measurements for the evaluation of potential exposures and doses. Comments are due October 29, 2010.
NRC cites the VA for problems with prostate brachytherapy programs at additional VA facilities
AAPM comments to FDA on Therapeutic Device Improvements
AAPM filed comments in response to FDA's request for comments related to device improvements to reduce the number of under- doses, over-doses and misaligned exposures from therapeutic radiation.
Click here to review the comments
NRC Issues Proposed Rule – Part 37 (75 FR 33901) Physical Protection of Byproduct Material; Proposed Rule
On June 15th, NRC issued a proposed rule 10 CFR Part 37, Physical Protection of Byproduct Material; Proposed Rule in the Federal Register.
The purpose is to amend NRC regulations to establish security requirements for the use and transport of category 1 and category 2 quantities of radioactive material, which the NRC considers to be risk-significant and therefore to warrant additional protection. Category 1 and category 2 thresholds are based on those established in the International Atomic Energy Agency (IAEA) Code of Conduct on the Safety and Security of Radioactive Sources, which NRC endorses. The objective of this proposed rule is to provide reasonable assurance of preventing the theft or diversion of category 1 and category 2 quantities of radioactive material. The proposed regulations would also include security requirements for the transportation of irradiated reactor fuel that weighs 100 grams or less in net weight of irradiated fuel. The proposed rule would affect any licensee that is authorized to possess category 1 or category 2 quantities of radioactive material, any licensee that transports these materials using ground transportation, and any licensee that transports small quantities of irradiated reactor fuel.
This rulemaking will codify the requirements in effect via specific orders issued to licensees with category 1 and category 2 sources.
Category 1 Threshold |
Category 2 Threshold |
|||
Radioactive Material |
Terabequerals |
Curies |
Terabequerals |
Curies |
|
(TBq) |
(CI) |
(TBq) |
(CI) |
Americium-241 |
60 |
1,620 |
0.6 |
16.2 |
Americium-241/Beryllium |
60 |
1,620 |
0.6 |
16.2 |
Californium-252 |
20 |
540 |
0.2 |
5.40 |
Curium-244 |
50 |
1,350 |
0.5 |
13.5 |
Cobalt-60 |
30 |
810 |
0.3 |
8.10 |
Cesium-137 |
100 |
2,700 |
1 |
27.0 |
Gaolinium-153 |
1,000 |
27,000 |
10.0 |
270 |
Iridium-192 |
80 |
2,160 |
0.8 |
21.6 |
Plutonium-238 |
60 |
1,620 |
0.6 |
16.2 |
Plutonium-239/Beryllium |
60 |
1,620 |
0.6 |
16.2 |
Promethium-147 |
40,000 |
1,080,000 |
400 |
10,800 |
Radium-226 |
40 |
1,080 |
0.4 |
10.8 |
Selenium-75 |
200 |
5,400 |
2.0 |
54.0 |
Strontium-90 (Yttrium-90) |
1,000 |
27,000 |
10.0 |
270 |
Thulium-170 |
20,000 |
540,000 |
200 |
5,400 |
Ytterbium-169 |
300 |
8,100 |
3.0 |
81.0 |
The proposed rule and additional information can be found at www.regulations.gov at NRC 2008-0120. Comments are due to NRC October 15, 2010. Comments specific to the information collection aspects of this proposed rule are due to NRC July 15, 2010.
In addition to the proposed rule, NRC has posted the following documents at www.regulations.gov NRC 2010-0194: Draft Implementation Guidance, Draft Regulatory Analysis, and Draft EA and FONSI for review and comment.
NRC plans to hold two public meetings or workshops on the rule and guidance. These are tentatively scheduled for September 1 in Austin TX and September 20 in Rockville.
If you have any questions, please contact Lynne Fairobent, AAPM’s Manager of Legislative and Regulatory Affairs at lynne@aapm.org.
NRC Commissioners Direct Staff to Rework Reproposed Rule: Medical Use of Byproduct Material – Amendments/Medical Event Definitions (RIN 3150-AI26)
The NRC Commissioners disapproved the staff’s recommendation to publish the reproposed amendments to Part 35 in the Federal Register. The Commissioners stated that:
- The staff should work closely with the Advisory Committee on the Medical Uses of Isotopes and the broader medical and stakeholder community to develop event definitions that will protect the interests of patients, allow physicians the flexibility to take actions that they deem medically necessary, while continuing to enable the agency to detect failures in process, procedure, and training as well as any misapplication of byproduct materials by authorized users.
- The staff should hold a series of stakeholder workshops to discuss issues associated with the medical event definition. Areas for discussion should include, but not limited to, methods for defining medical events which continue to ensure the safe use of radioactive materials while providing flexibility to account for medically necessary adjustments and the terms and thresholds for reporting medical events to the NRC and patients.
- Given the recent Commission vote, the current regulation will remain effective until the staff completes the additional outreach to stakeholders.
In the August 6, 2008 Federal Register (73 FR 45635) NRC initially proposed a rule to amend 10 CFR Part 35 related to reporting and notification of medical events and to clarify requirements for permanent implant brachytherapy. NRC received a total of 57 comment letters. Many of the comments were form letters with identical language. Most of the comments were from medical universities, hospitals, private physicians, and professional organizations representing the medical community. The comments were primarily not supportive of parts of the rulemaking.
NRC has had the final rule on hold due to the substantial number of medical events that were reported to the NRC during late summer and early fall of 2008. NRC staff has been reviewing and analyzing the circumstances of, and data from, these events. Based on its evaluation of this information, including an independent analysis by an NRC medical consultant, the NRC staff believes that a number of medical events that were reported in 2008 would not be categorized as medical events under the proposed rule published on August 6, 2008. NRC staff believes this is inconsistent with the original regulatory intent, which was to clarify the requirements for permanent implant brachytherapy so that licensees would be able to identify medical events more easily and in a more timely manner. An unintended effect of the proposed rule would have been that some significant events would not be identified, categorized, and reported as medical events. Additionally, the evaluation of the circumstances and data from the substantial number of medical events reported in 2008 prompted the staff to reevaluate the regulations related to training requirements and time frames for licensees to assess the dose to the treatment site for permanent implant brachytherapy. Therefore, the proposed rule language and rationale have been modified to reflect this new information and the NRC staff is recommending that the Commission publish the revised proposed rule for public comment.
The reproposed rule would amend the current regulations by:
(1) adding activity-based criteria for defining some medical events for permanent implant brachytherapy;
(2) adding a requirement to report, as a medical event, any administration requiring a written directive (WD) if a WD is required and not prepared, and documentation in medical records or licensees’ standard written procedures that existed prior to the administration is insufficient to determine if a medical event has occurred;
(3) clarifying requirements for WDs for permanent implant brachytherapy;
(4) adding a requirement that licensees provide and document training to their staff on the requirements of § 35.3045;
(5) adding a requirement that licensees must assess the dose to the treatment site no later than 60 days from the date that the patient leaves the post-treatment recovery area; and
(6) making certain administrative and clarification changes.
The reproposed rule would facilitate the ability of medical licensees to recognize some medical events in permanent implant brachytherapy earlier and, therefore, be able to take corrective actions sooner than under current regulations. These changes to the regulations are based in part on recommendations from the ACMUI as well as the staff’s evaluation of the circumstances of, and data from, the substantial number of medical events reported in 2008.
SECY-10-0062 provides the staff’s recommendations to the Commission. Included in the draft staff paper are: the comments received on the proposed rule published on August 6, 2008, and the changes made to the proposed rule as a result of the evaluation of the circumstances of and data from the substantial number of medical events reported in 2008, are discussed in detail in the draft Federal Register Notice. Additionally, per SRM-COMSECY-09-0026, “Request For Rebaselining of Medical Event Definition Rulemaking to Reflect Recent Veterans Administration Experience” changes made to the proposed rule language published on August 6, 2008, are highlighted in Rule Language Changes.
The Commission has scheduled a hearing on July 8th to discuss the staff’s recommendations and to hear input from the stakeholder community. AAPM has been invited to testify. After the Commission briefing, the Commissioners will vote on issuing the reproposed rule.
If you have any questions, please contact Lynne Fairobent, AAPM’s Manager of Legislative and Regulatory Affairs at lynne@aapm.org.
AAPM testifies before Congress on Radiation use in Medicine
FDA Launches Medical Device and Radiation-Emitting Product Transparency Web site
Mon, 19 Apr 2010
The U.S. Food and Drug Administration launched the Center for Devices and Radiological Health (CDRH) Transparency Web site today as part of the agency’s transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.
House Passes H.R. 3672 - American Medical Isotopes Production Act of 2009
Posted 12-10-2009
Representative Markey (MA-7) introduced H.R. 3276 on July 21, 2009. The purpose of this legislation is to help patients who rely on medical imaging for the treatment and diagnosis of many common cancers by authorizing funding and providing a clear road map to create a domestic supply of Mo-99 while also allowing a responsible time line and safeguards for the transfer of HEU to low enriched uranium (LEU). AAPM supports this legislation and continues to work with the Senate on passage. AAPM correspondence related to this:
1. July 15, 2009 AAPM Letter to Rep. Markey
2. December 2, 2009 AAPM Letter Senate Energy Subcommittee
3. Coalition paper on medical isotope supply
NRC REQUESTS COMMENTS ON DRAFT SAFETY CULTURE POLICY STATEMENT
Posted 12-10-2009
In the November 6, 2009 Federal Register (74 FR 57525) [http://edocket.access.gpo.gov/2009/pdf/E9-26816.pdf], the Nuclear Regulatory Commission (NRC) requested comments on a draft Safety Culture Policy Statement. Comments are due February 5, 2010 (90 days after publication). The NRC is issuing a draft policy statement that sets forth the Commission’s expectation that all licensees and certificate holders establish and maintain a positive safety culture that protects public health and safety and the common defense and security when carrying out licensed activities. The Commission defines safety culture as that assembly of characteristics, attitudes, and behaviors in organizations and individuals which establishes that as an overriding priority, nuclear safety and security issues receive the attention warranted by their significance. Background information related to NRC Safety Culture can be found at: http://www.nrc.gov/about-nrc/regulatory/enforcement/safety-culture.html.
NRC CONSIDERING REVISING RADIATION PROTECTION REGULATIONS
Posted 12-10-2009
The U.S. Nuclear Regulatory Commission (NRC) is seeking public comment on potential changes to the NRC’s current radiation protection regulations to achieve greater alignment between the regulations and the 2007 recommendations of the International Commission on Radiological Protection (ICRP) contained in ICRP Publication 103. The Nuclear Regulatory Commission is looking at implementing ICRP Report 103, which includes a reduction in the annual personnel exposure limit from 50 Sv to 20 Sv. These limits would apply beyond Nuclear Medicine departments and include Cardiology and Interventional Radiology workers. AAPM is responding to NRC on this issue, but individual comments are welcome. Please see http://www.nrc.gov/about-nrc/regulatory/rulemaking/opt-revise.html for more information. The Federal Register notice can be found at: http://edocket.access.gpo.gov/2009/pdf/E9-15950.pdf. If you have input that AAPM should consider in drafting its response, please send your comments to Lynne Fairobent, Manager of Legislative and Regulatory Affairs at lynne@aapm.org by February 1, 2010.
AAPM comments on draft ICRP Report 103
NEW CARE Bill: H.R. 3652 – Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009
Posted 12-10-2009
The CARE Bill (stands for the Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009) has been introduced in the House [H.R. 3652] by Rep. John Barrow (D – GA) [http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.3652:]. As of December 10, 2009,this Bill had 11 co-sponsors [Rep. Marsha Blackburn (TN-7); Rep. Michael Castle, (DE); Bob Etheridge (NC-2); Tom Latham,(IA-4), Edward j. Markey (MA-7), Patrick Tiberi (OH-12), Bruce Braley (IA-1), Stephanie Herseth Sandlin (SD), Randy J. Forbes (VA-4), Russ Carnahan (MO-3), and Jim Moran (VA-8), ]. The House Bill, with one exception, is identical to that introduced in the 110th Congress. The exception is the inclusion [Page 12, lines 8-10] recognizing the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) Bill passed in the 110th Congress. The MIPPA Bill only applies to advanced imaging procedures (PET, CT, MR and nuclear medicine) performed in free standing clinics. Work is under way identifying a sponsor and introduction of a parallel bill in the Senate.
NRC Announces Enforcement Conference for VA Medical Center, Philadelphia, Pennsylvania
Posted 12-10-2009
On December 17, 2009, NRC will hold an enforcement conference to discuss the Commission’s finding related to the Philadelphia Veteran’s Affairs (VA) event. The conference will be held in Rockville, MD and be available via toll free audio cast.... [Read More]
NRC Releases Guidance on Microsphere Brachytherapy Sources and Devices
Posted 9-04-08
NRC staff evaluated Yttrium-90 (Y-90) microspheres which are regulated under 10 CFR 35.1000 "Other Medical Uses of Byproduct Material or Radiation for Byproduct Material" and in August 2008 issued a revised guidance document including additional specific training and experience requirements.
AAPM Recent Comments to Federal Agencies
updated 1-28-09
2009 Comments
AAPM Provides Comments to the Nuclear Science Advisory Committee Isotope Subcommittee. 1-13-09 Additional information related to the NSACI is posted on the GRAC website.
2008 Comments
AAPM Provides Comments to the NRC on CsCl Sources 10-15-08
AAPM Submits Nominations for the NRC's Advisory Committee on Medical uses of Isotopes
AAPM Sends Letter to NRC chairman Klein re: Petition Determination on 10 CFR Part 35 T&E 9-22-08
AAPM Submits Comments on NRDC Petition re: HEU
AAPM Provides Comments to NRC on the Proposed Rule to Expand the National Source Tracking System.
FDA Issues Public Health Notification
Posted 7-15-08
FDA informed healthcare professionals of the possibility that x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. Most patients with electronic medical devices undergo CT scans without any adverse consequences. However, the Agency has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. FDA is continuing to investigate the issue and is working with the manufacturer to raise awareness in the healthcare community. See the FDA Public Health Notification for a description of adverse event reports and recommendations regarding reducing the potential risk to patients.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Public Health Notification regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#ElectronicMedical
AAPM comments on the draft FDA public health notification posted 04-08
House, Senate Override President's Veto Of Medicare Bill
Posted July 16, 2008
The House voted 383-41 Tuesday afternoon to override President Bush's veto
earlier in the day of Medicare legislation, and the Senate followed suit
with a 70-26 vote. President Bush vetoed the Medicare bill, as senior
administration officials vowed yesterday he would do, railing against
provisions cutting Medicare Advantage and reforming Part D. The bill earlier
passed both chambers by veto-proof margins.
NRC Issues Revision to Regulatory Guides 6.1 and 10.2
Posted July 14, 2008
Regulatory Guide 6.1 Leak Testing Radioactive Brachytherapy Sources: This regulatory guide endorses the method described in Volumes 3 and 9 of NUREG-1556 as a process that the NRC has found to be acceptable for meeting the regulatory requirements for leak testing of radioactive brachytherapy sources. Link to NUREG-1556: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/r2/
Regulatory Guide 10.2 Guidance to Academic institutions Applying for Licences of Limited Scope: This regulatory guide endorses the methods and procedures for limited scope byproduct material licensing contained in the current revision of NUREG-1556, Volume 7, “Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Academic, Research, and Development, and Other Licenses of Limited Scope” (Ref. 4), as a process that the NRC staff has found acceptable for meeting the regulatory requirements. Link: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v7/
Senate Passes Medicare Bill 7-10-08
Posted July 14, 2008
The Senate has passed the Medicare bill (H.R. 6331) which averts the 10.6% decrease tothe conversion factor effective July 1st and mandates an additional 1.1% increase in the(January 1, 2008-June 30, 2008) conversion factor for 2009. In essence, theestimated 16% across the board reduction to physician and freestandingclinic payments effective January 1, 2009 has now become a slight 1.1% increase to payments implemented on January 1, 2008.The White House reports that the President will veto the bill, however, the legislation passed both the House and Senate by a large margin to likely secure a veto-proof physician payment fix package.
Senate Health, Education, Labor and Pensions (HELP) Committee passes S. 1042 CARE legislation out of committee
Posted March 15, 2008
On Thursday, March 13, 2008, the Senate HELP committee voted to move forward the Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy bill, or CARE bill (S. 1042) out of committee. Thank you to all AAPM members that called their Senators and Representatives to date on this legislation. In the next couple of weeks, members of Congress will be in their home districts for Easter recess, please contact their offices and ask that they support the passing of S. 1042 and H.R. 583 as soon as possible upon return from the spring recess. If you have not done so, it is not too late go to: http://capwiz.com/aapm/home/ and follow the instructions for calling or emailing your members. If you have contacted your members, please follow up and ask what action have they taken based on your request.
If you have questions, please contact, Lynne Fairobent, AAPM's manager of Legislative and Regulatory Affairs at lynne@aapm.org.
Action Alert: CARE Legislation - Senate HELP committee key members 
Posted: February 13, 2008
The Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy (CARE) legislation (S.1042) is scheduled for mark up by the Senate Health, Education, Labor & Pension (HELP) committee. As such it is especially vital the AAPM members that reside in states where the members of the Senate HELP committee are from, call their Senator and ask that the bill be moved forward without additional amemdment. Key Senators that we are targeting are: Senator Harkin (Iowa), Mikulski (Maryland), Murray (Washington), Reed (Rhode Island), Clinton (New York), Obama (Illinois), Brown (Ohio), Gregg (New Hampshire), Alexander (Tennessee), Murkowski (Alaska), Roberts (Kansas), Allard (Colorado) and Coburn (Oklahoma).
To show you CARE about quality care and health care costs, please visit the Legislative Action Center and use the supplied communication tools to quickly and easily contact your legislators.
“Source Collection and Threat Reduction” (SCATR) Program -
The Conference of Radiation Control Program Directors (CRCPD) and the Department of Energy have initiated a rare opportunity for radioactive material licensees to have financial assistance in properly disposing of unwanted sealed sources. The program is entitled “Source Collection and Threat Reduction” or “SCATR.” The AAPM endorses the SCATR program and encourages AAPM members to have their licensees register and take advantage of this opportunity. For additional information and to register your sources click here CRCPD SCATR.
Federal Agency Issues
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).
Comments filed by the AAPM
Archived Information