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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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