[ RadSafe ] NRC Issues a Regulatory Issue Summary Regarding Dose Limit for Patient (Find the mistake!!!!)

[Boby Mathew]

Dear All
  Please find the mistake in the press release from NRC regarding the Dose Limit for Patient Release Under 10 CFR 35.75. See how they have converted 0.5 mSv to 0.5 rem in one place and 5 mSv to 0.5 rem under the background title. Though i have  little radiation safety background, i myself got confused after reading the article. Another example of how we confuse the public and experts.
  Boby
   
   
  UNITED STATES
  NUCLEAR REGULATORY COMMISSION
  OFFICE OF FEDERAL AND STATE MATERIALS AND ENVIRONMENTAL
  MANAGEMENT PROGRAMS
  WASHINGTON, D.C. 20555
  March 27, 2008
  NRC REGULATORY ISSUE SUMMARY 2008-07
  DOSE LIMIT FOR PATIENT RELEASE UNDER 10 CFR 35.75
  ADDRESSEES
  All U.S. Nuclear Regulatory Commission (NRC) medical use licensees and NRC Master
  Material Licensees. All Radiation Control Program Directors, and State Liaison Officers.
  INTENT
  The NRC is issuing this regulatory issue summary (RIS) to inform all addressees that the NRC
  intends to pursue rulemaking to clarify the 0.5 millisievert (mSv) (0.5 rem) limit in 10 CFR 35.75
  as an annual limit, rather than a per-release limit. This rulemaking is being pursued because
  the NRC has determined that the regulation as it is now written does not incorporate the NRC=s
  intent in having promulgated this regulation.
  BACKGROUND
  10 CFR 35.75 (a) provides:
  A licensee may authorize the release from its control of any individual who has been
  administered unsealed byproduct material or implants containing byproduct material if
  the total effective dose equivalent [TEDE] to any other individual from exposure of the
  released individual is not likely to exceed 5 mSv (0.5 rem).
  The dose-based criterion in 10 CFR 35.75 for release of patients or human research subjects to
  whom byproduct material has been administered was established in 1997, when the NRC
  amended its regulations to provide for a dose-based rather than activity-based limit for release
  of these individuals who have been administered unsealed byproduct material or implants
  containing byproduct material (see 62 FR 4124). Licensees have asked whether, in cases in
  which an individual is given a series of administrations over time, the dose-to-others criterion
  applies to each of the administrations separately, or whether the dose-to others criterion for
  release of the individual is an annual dose limit. While the regulatory history of the 1997
  addition to 10 CFR Part 35 that established the patient release criteria in '35.75 supports the
  intent of an annual dose limit interpretation, the wording of the regulation, which has not been
  changed since 1997, is ambiguous.
  RIS 2008-07
  Page 2 of 3
  ML063030572
  SUMMARY OF ISSUE
  As explained in the Supplementary Information accompanying the final rule (62 FR 4124,
  January 29, 1997) the NRC proposed to adopt a new 10 CFR 35.75(a) to change the patient
  release criteria from 1,110 megabecquerels (30 millicuries) of activity in a patient, or a dose rate
  of 0.05 millisievert (5 millirem) per hour at 1 meter from a patient, to a TEDE not to exceed 5
  millisieverts (0.5 rem) in any one year to an individual from exposure to a released patient. The
  Supplementary Information states that this release limit was consistent with the
  recommendations of the International Commission on Radiological Protection (ICRP) in ICRP
  Publication 60, A1990 Recommendations of the International Commission on Radiological
  Protection,@ and the National Council on Radiation Protection and Measurements (NCRP) in
  NCRP Report Number 116, ALimitation of Exposure to Ionizing Radiation.@ Each of these
  recommendations provided a basis for allowing individuals to receive annual doses up to 5
  millisieverts (0.5 rem) in a given year in situations when exposure to radiation is not expected to
  result in doses above 1 millisievert (0.1 rem) per year for a long period of time, as would be the
  case for doses from released patients. Current ICRP and NCRP recommendations on doses to
  individuals from exposure to a released patient are still consistent with the above-cited earlier
  recommendations from these advisory organizations.
  The wording of '35.75, which does not indicate that the dose limit is an annual limit, was based
  on the presumption, appropriate at the time the regulation was being developed, that an
  individual who received a therapeutic radiopharmaceutical dosage or a therapeutic sealed
  source permanent implant and was released under the restrictions of '35.75 was highly unlikely
  to receive another treatment and again be released under '35.75 within a year, i.e., to receive
  multiple administrations and to undergo multiple releases within a given year. The presumption
  that patients receive single administrations of therapeutic doses in a given year, which is the
  basis used in developing the wording for the dose limit in '35.75, is no longer valid. Several
  licensees have described patient treatment protocols involving multiple therapeutic
  administrations, and in some cases multiple patient releases under '35.75, in a given year.
  If multiple administrations or applications in a single year are planned, anticipated, or potentially
  may be required for an individual, the decision about releasing that individual following each of
  the administrations should, in NRC=s view, be based on the cumulative TEDE from all
  administrations or applications in a given year not exceeding 5 mSv (0.5 rem) for the maximally
  exposed other individual.
  The position of the NRC, supported by the recommendations of both national and international
  organizations, remains that there should be an annual limit on the dose to other individuals from
  the release of an individual under the provisions of 10 CFR 35.75.
  Therefore, NRC intends to pursue rulemaking to establish the 0.5 millisievert (mSv) (0.5 rem)
  limit in 10 CFR 35.75 as an annual limit. The normal procedures for rulemaking, including
  opportunity for public comment, will be followed.
  RIS 2008-07
  Page 3 of 3
  FEDERAL REGISTER NOTIFICATION
  A notice of opportunity for public comment on this RIS was not published in the Federal Register
  because this RIS is informational and does not represent a departure from current regulatory
  requirements.
  CONGRESSIONAL REVIEW ACT
  In accordance with the Congressional Review Act, the NRC has determined that this RIS is not
  a major rule, and the Office of Information and Regulatory Affairs of the Office of Management
  and Budget (OMB) has confirmed this determination.
  PAPERWORK REDUCTION ACT STATEMENT
  This RIS references information collection requirements that are subject to the Paperwork
  Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were approved
  by the Office of Management and Budget, approval number 3150-0010.
  Public Protection Notification
  The NRC may not conduct or sponsor, and a person is not required to respond to, a request for
  information collection requirement unless the requesting document displays a currently valid
  OMB control number.
  CONTACT
  This RIS requires no specific action or written response. If you have any questions about this
  summary, please contact one of the individuals listed below or the appropriate regional office.
  /RA/
  Robert Lewis, Director
  Division of Materials Safety
  and State Agreements
  Office of Federal and State Materials
  and Environmental Management Programs
  Technical Contact: Ronald Zelac, FSME
  (301)415-7635
  E-mail: rez at nrc.gov
  Enclosure:
  List of Recently Issued FSME
  Generic Communications
  RIS 2008-07
  Page 3 of 3
  FEDERAL REGISTER NOTIFICATION
  A notice of opportunity for public comment on this RIS was not published in the Federal Register because this RIS is
  informational and does not represent a departure from current regulatory requirements.
  CONGRESSIONAL REVIEW ACT
  In accordance with the Congressional Review Act, the NRC has determined that this RIS is not a major rule, and the
  Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB) has confirmed this
  determination.
  PAPERWORK REDUCTION ACT STATEMENT
  This RIS references information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44
  U.S.C. 3501 et seq.). These information collections were approved by the Office of Management and Budget,
  approval number 3150-0010.
  Public Protection Notification
  The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information collection
  requirement unless the requesting document displays a currently valid OMB control number
  CONTACT
  This RIS requires no specific action or written response. If you have any questions about this summary, please
  contact one of the individuals listed below or the appropriate regional office.
  /RA/
  Robert Lewis, Director
  Division of Materials Safety
  and State Agreements
  Office of Federal and State Materials
  and Environmental Management Programs
  Technical Contact: Ronald Zelac, FSME
  (301)415-7635
  E-mail: rez at nrc.gov
  Enclosure:
  List of Recently Issued FSME
  Generic Communications
  ML063030572
  OFC
  DMSSA/MSEA
  TechEd
  DMSSA/MSEA
  DMSSA/MSEA DMSSA/MSEA
  NAME
  RZelac:smh
  EKraus FAX
  CFlannery
  MLO for AMcIntosh SWastler
  DATE 10/02/07 10/31/06 10/02/07 12/11/06 10/12/07
  OFC OIS OGC OGC DMSSA
  NAME TDonnell FCameron TRothschild RLewis
  DATE 12/04/07 11/08/07 11/15/07 2/27/08 / /08
  OFFICIAL RECORD COPY
  RIS 2008-07
  Enclosure 1
  Page 1 of 1
  List of Recently Issued FSME Generic Communications
  Date GC No. Subject Addressees
  10/04/07 RIS-07-22 Status Update For
  Implementation Of NRC
  Regulatory Authority for
  Certain Naturally-Occurring
  and Accelerator-Produced
  Radioactive Material
  All U.S. Nuclear Regulatory
  Commission materials licensees,
  radiation control program directors,
  State liaison officers, and the
  NRC’s Advisory Committee on the
  Medical Uses of Isotopes.
  10/04/07 RIS-07-23 Date For Operation Of
  National Source Tracking
  System
  All licensees authorized to possess
  Category 1 or Category 2 quantities
  of radioactive materials. All
  Radiation Control Program
  Directors and State Liaison
  Officers.
  12/05/07 RIS-07-27 Improving Public
  Understanding of the Risks
  Associated with Medical
  Events
  All U.S. Nuclear Regulatory
  Commission medical use
  licensees. All Radiation Control
  Program Directors, and State
  Liaison Officers
  12/07/07 RIS-07-28 Security Requirements for
  Portable Gauges
  U.S. Nuclear Regulatory
  Commission portable gauge
  licensees and Agreement State
  Radiation Control Program
  Directors and Liaison Officers
  12/14/07 RIS-07-38 Ensuring Complete and
  Accurate Information iIn the
  Documentation of Training
  and Experience for
  Individuals Seeking Approval
  as Medical Authorized Users
  All U.S. Nuclear Regulatory
  Commission medical use licensees
  and NRC master materials
  licensees. All Agreement State
  Radiation Control Program
  Directors and State Liaison Officers
  02/01/08 RIS 2008-
  02
  Actions to Increase the
  Security of High Activity
  Radioactive Sources
  All U.S. Nuclear Regulatory
  Commission Materials and Master
  Materials Licensees. All Agreement
  State Radiation Control Program
  Directors and State Liaison
  Officers.
  Note: This list contains the six most recently issued generic communications. A full listing of
  generic communications may be viewed at the NRC public website at the following address:
  http://www.nrc.gov/reading-rm/doc-collections/gen-comm/index.html

       
---------------------------------
You rock. That's why Blockbuster's offering you one month of Blockbuster Total Access, No Cost.