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[COL Peter Myers 289-0132: Proposed NRC Rule - Release of Patients]



The regulators are keeping busy! Viz.:


----- Forwarded message # 1:

Date:     Mon, 27 Jun 94 12:54:01 EDT
From:     COL Peter Myers 289-0132  <pmyers@aeha1.apgea.army.mil>
To:       pmonddn.68b@aeha1.apgea.army.mil
Subject:  Proposed NRC Rule - Release of Patients


               U.S. NUCLEAR REGULATORY COMMISSION
 
                    Office of Public Affairs
                     Washington, D.C.  20555
 
NUREG/BR-0032                                       301-415-8200
 
VOL.  14, No. 25                       Week Ending June 22, 1994
 
                          NEWS RELEASES
 
No. 94-99                                          June 16, 1994
 
                    NRC PROPOSES REVISIONS TO
                    REGULATIONS ON RELEASE OF
                 PATIENTS ADMINISTERED BYPRODUCT
                            MATERIAL
 
 
    The Nuclear Regulatory Commission is proposing to amend its 
regulations to clarify which portions govern the release of 
patients from a hospital or other licensed medical facility 
after they have received radioactive material for treatment or 
diagnostic purposes.  The revisions would also update the 
regulations and respond to two petitions received on this 
subject.
 
    From a health and safety viewpoint, the proposed standard 
for patient release is essentially the same as the present 
standard.
 
    Radioactive pharmaceuticals or implants are administered to 
approximately 8 to 9 million patients in the United States each 
year for diagnosis or treatment of disease.  These patients can 
expose other persons around them to radiation until the 
radioactive material has been excreted from their bodies or has 
become less intense due to radioactive decay.
 
    Under the proposed rule, patients could not be released if 
the estimated dose to any individual from exposure to the 
patient would be greater than 500 millirems in any one year.  
(Typical natural background radiation in the United States is 
300 millirems per year.)  The new criteria would be consistent 
with the recommendations of the International Commission on 
Radiological Protection.
 
    Current NRC requirements on the release of patients 
containing radioactive material are contained in a portion of 
the Commissions's regulations that deals specifically with 
medical uses of radioactive material.  Medical licensees are not 
permitted to authorize the release of patients to whom nuclear 
material has been administered until either (1) the measured 
dose rate from the patient is less than 5 millirems per hour at 
a distance of 1 meter or (2) the radiopharmaceutical content of 
the patient is less than 30 millicuries.  For the most commonly 
used radioactive material, this is equivalent to approximately 
500 millirems per year.
 
    When the Commission's new regulations on general radiation 
protection standards, which became mandatory on January 1, were 
published, the question arose (as evidenced by petitions for 
rulemaking) as to whether it was the Commission's intention to 
supersede the specific requirements for release of patients.  In 
fact, the Commission did not.
 
    The proposed rule would therefore amend the general 
radiation protection regulations to exclude doses to individuals 
exposed to released patients.  Release of patients containing 
radioactivity would be governed by the more explicit 
requirements of the specific medical-use regulation.
 
    The medical-use regulation would simultaneously be revised 
from the current 5 millirems per hour at 1 meter or 30 
millicuries radiopharmaceutical content to a flat estimated 500 
millirems maximum per year to an individual exposed to the 
patient.  This change would provide flexibility to allow 
case-by-case calculation of doses in special circumstances, such 
as when a released patient lives alone.  In addition, the change 
would allow licensees to take into account the specific 
characteristics of the radioactive material to be used, while 
maintaining a consistent overall level of protection.
 
    Before releasing a patient, licensees would be required to 
determine the expected radiation dose to individuals exposed to 
the patient, taking into account the fact that radiation decays 
and that the dose rate immediately upon release would be higher 
than the dose rate a few days or weeks later.  The NRC is 
issuing a draft Regulatory Guide DG-8015, "Release of Patients 
Administered Radioactive Material," that includes a table and 
method for estimating the annual dose.  Single copies are 
available by written request to:  Printing and Mail Services 
Branch, Office of Administration, U.S. Nuclear Regulatory 
Commission, Washington, DC  20555, or Fax:  (301) 504-2260.
 
    In addition to the 500-millirems-per-year limit, the 
proposed rule would require that, if the annual dose to an 
individual exposed to the patient is likely to exceed 100 
millirems, the licensee would have to:
 
    (1)  Provide the patient with written instructions on how to 
maintain doses to other individuals as low as reasonably 
achievable and
 
    (2)  Maintain for three years a record of the released 
patient and the calculated total dose to the individual likely 
to receive the highest dose from the patient.
 
    The draft Regulatory Guide provides guidance on acceptable 
instructions and recordkeeping.
 
    The proposed revisions would partially grant two petitions 
for rulemaking on criteria for release of patients who have been 
administered radioactive material.  On June 12, 1991, March 9, 
1992, and May 18, 1992, the NRC published Federal Register 
Notices concerning receipt of the petitions from Dr. Carol S. 
Marcus and the American College of Nuclear Medicine.  The 
proposed rule reflects public comments received.
 
    Interested persons are invited to submit written comments on 
the proposed changes, which are to Parts 20 and 35 of the 
Commission's regulations, by August 29 (75 days after 
publication of a notice in the Federal Register on June 15).
 
    The comments should be addressed to Secretary of the 
Commission, U.S. Nuclear Regulatory Commission, Washington, DC 
20555, Attention:  Docketing and Service Branch.


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