Nuclear Medicine Clarification Act of 2025
This bill requires the Nuclear Regulatory Commission (NRC) to revise its regulations so that health care providers must report to the NRC when a dose of a radioactive drug caused by an extravasation exceeds specified quantities. An extravasation generally means the unintentional presence of a radioactive drug in the tissue surrounding the blood vessel following an injection.
Under the NRC’s current regulations, health care providers licensed by the NRC to use radioactive materials must submit a report to the NRC for any instance, known as a medical event, where the administered dose of a radioactive drug exceeds specified quantities or criteria.
In 2024, the NRC published a draft proposed rule that would add an extravasation as a medical event that must be reported. The draft proposed rule’s reporting threshold is based on a physician’s determination that the administration results or may potentially result in a radiation injury from an extravasation. The reporting threshold proposed by the NRC does not contain a quantified dose.
The bill requires the NRC to revise its regulations to add an extravasation as a medical event that must be reported, and it additionally requires the reporting threshold to be based on quantified doses (as specified in the bill).
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2541 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 2541
To require the Nuclear Regulatory Commission to revise its regulations
to protect patients from unintended exposure to radiation during
nuclear medicine procedures, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 1, 2025
Mr. Davis of North Carolina (for himself, Mr. Griffith, and Mr. Cline)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To require the Nuclear Regulatory Commission to revise its regulations
to protect patients from unintended exposure to radiation during
nuclear medicine procedures, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Nuclear Medicine Clarification Act
of 2025''.
SEC. 2. MEDICAL EVENT REPORTING OF UNINTENDED IRRADIATION.
(a) Revision of Regulations Required.--Not later than 120 days
after the date of enactment of this Act, the Nuclear Regulatory
Commission shall revise section 35.3045(a)(1) of title 10, Code of
Federal Regulations, by adding at the end the following:
``(iv) A dose that is due to an extravasation and exceeds--
``(A) 0.5 Sv (50 rem) dose equivalent to the 5 cubic centimeter
volume of tissue receiving the highest absorbed dose during residence
time; or
``(B) 0.5 Sv (50 rem) shallow dose equivalent to the contiguous 10
square centimeters of skin receiving the highest absorbed dose during
residence time.''.
(b) Effective Date.--The revision required under subsection (a)
shall take effect on the date that is 18 months after the date of
enactment of this Act.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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