[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.75]

[Page 567]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
                Subpart C--General Technical Requirements
 
Sec. 35.75  Release of individuals containing radiopharmaceuticals or permanent implants.

    (a) The licensee may authorize the release from its control of any 
individual who has been administered radiopharmaceuticals or permanent 
implants containing radioactive material if the total effective dose 
equivalent to any other individual from exposure to the released 
individual is not likely to exceed 5 millisieverts (0.5 rem).\1\
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    \1\Regulatory Guide 8.39, ``Release of Patients Administered 
Radioactive Materials,'' describes methods for calculating doses to 
other individuals and contains tables of activities not likely to cause 
doses exceeding 5 millisieverts (0.5 rem).
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    (b) The licensee shall provide the released individual with 
instructions, including written instructions, on actions recommended to 
maintain doses to other individuals as low as is reasonably achievable 
if the total effective dose equivalent to any other individual is likely 
to exceed 1 millisievert (0.1 rem). If the dose to a breast-feeding 
infant or child could exceed 1 millisievert (0.1 rem) assuming there 
were no interruption of breast-feeding, the instructions shall also 
include:
    (1) Guidance on the interruption or discontinuation of breast-
feeding and
    (2) Information on the consequences of failure to follow the 
guidance.
    (c) The licensee shall maintain a record of the basis for 
authorizing the release of an individual, for 3 years after the date of 
release, if the total effective dose equivalent is calculated by:
    (1) Using the retained activity rather than the activity 
administered,
    (2) Using an occupancy factor less than 0.25 at 1 meter,
    (3) Using the biological or effective half-life, or
    (4) Considering the shielding by tissue.
    (d) The licensee shall maintain a record, for 3 years after the date 
of release, that instructions were provided to a breast-feeding woman if 
the radiation dose to the infant or child from continued breast-feeding 
could result in a total effective dose equivalent exceeding 5 
millisieverts (0.5 rem).

[62 FR 4133, Jan. 29, 1997]