[Federal Register Volume 64, Number 162 (Monday, August 23, 1999)]
[Proposed Rules]
[Pages 45907-45908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21792]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

[Docket No. PRM-35-15]


Jeffery C. Angel; Receipt of Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking; Notice of receipt.

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SUMMARY: The Nuclear Regulatory Commission (NRC) has received and 
requests public comment on a petition for rulemaking filed by Jeffery 
C. Angel. The petition has been docketed by the Commission and has been 
assigned Docket No. PRM-35-15. The petitioner requests that the NRC 
amend its regulations concerning the medical use of byproduct material 
to prohibit the hand-held administration of radiopharmaceuticals by 
injection and to require the use of the Angel Shield, a device to 
administer radioactive substances. The petitioner requests that the NRC 
take this action to make the administration of radiopharmaceuticals by 
injection safer.

DATES: Submit comments by November 8, 1999. Comments received after 
this date will be considered if it is practical to do so, but assurance 
of consideration cannot be given except as to comments received on or 
before this date.

ADDRESSES: Submit comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555. Attention: Rulemakings and 
Adjudications staff.
    Deliver comments to 11555 Rockville Pike, Rockville, Maryland, 
between 7:30 am and 4:15 pm on Federal workdays.
    For a copy of the petition, write to David L. Meyer, Chief, Rules 
and Directives Branch, Division of Administrative Services, Office of 
Administration, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001.
    You may also provide comments via the NRC's interactive rulemaking 
website at http://ruleforum.llnl.gov. This site provides the capability 
to upload comments as files (any format), if your web browser supports 
that function. For information about the interactive rulemaking 
website, contact Ms. Carol Gallagher, (301) 415-5905 (e-mail: 
[email protected]).

FOR FURTHER INFORMATION CONTACT: David L. Meyer, Office of 
Administration, U.S. Nuclear Regulatory Commission, Washington, DC 
20555. Telephone: 301-415-7162 or Toll-free: 1-800-368-5642 or E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    On June 29, 1999, the Nuclear Regulatory Commission (NRC) received 
a petition for rulemaking submitted by Jeffery C. Angel. The petitioner 
requests that the NRC amend its regulations concerning the medical use 
of byproduct material to prohibit the hand-held administration of 
radiopharmaceuticals by injection and require the use of the Angel 
Shield, a device to administer radioactive substances. The petitioner 
requests that the NRC take this action to make the administration of 
radiopharmaceuticals by injection safer. The petition has been docketed 
as PRM-35-15. The NRC is soliciting public comment on the petition for 
rulemaking.
    The NRC's regulations governing the medical use of byproduct 
material appear in 10 CFR Part 35. Paragraph (c) of Sec. 35.60 requires 
that an individual use a syringe radiation shield when administering a 
radiopharmaceutical by injection unless the use of the shield is 
contraindicated for that patient or human research subject.

Discussion

    The petitioner states that the current practice of placing the 
radiopharmaceutical into a syringe radiation shield and delivering a 
hand-held injection places the person administering the substance in 
direct

[[Page 45908]]

and immediate contact with the radiopharmaceutical. The petitioner 
contends that this practice results in the unnecessary exposure of this 
individual to radiation. The petitioner asserts that the design and 
engineering of syringe radiation shields is not based on sound 
radiation protection principles. The petitioner further states that 
current syringe designs violate the fundamental radiation principles of 
time, shielding, and distance. The petitioner states that syringe 
radiation shields provide inadequate radiation protection because--
    1. They are hand held, thereby placing an administrator in direct 
and immediate contact with the radioactive substance;
    2. They must be light enough so that they are not cumbersome to 
work with and consequently, they do not incorporate enough shielding to 
protect administrators adequately; and
    3. There is no shielding at the distal or proximal portions of the 
shield, which results in direct and unnecessary radiation exposure.
    The petitioner refers to the provisions of 10 CFR 20.1101(b) that 
require licensees to use procedures and engineering controls based on 
sound radiation protection principles to achieve occupational dose 
rates that are as low as is reasonably achievable (ALARA).

The Petitioner's Request

    The petitioner requests that the NRC amend its regulations 
concerning the medical use of byproduct material to prohibit the hand-
held administration of radiopharmaceuticals by injection. As an 
alternative, the petitioner suggests that the NRC require the use of 
the Angel Shield, a radioactive substance administrator that eliminates 
the hand-held administration of radiopharmaceuticals by injection. The 
petitioner believes that radiation exposure rates would be immediately 
and substantially reduced through the use of the Angel Shield. The 
petitioner asserts that the Angel Shield reduces radiation exposure 
by--
    1. Eliminating the hand-held injection of radiopharmaceuticals;
    2. Encapsulating the syringe within the administrator completely 
thereby providing 360 degrees of protection;
    3. Shielding 100 percent of low-energy emissions (140 kev) and 88 
percent of high-energy emissions (511 kev);
    4. Allowing for the remote administration of the 
radiopharmaceutical; and
    5. Reducing the number of missed injections and subsequent multiple 
exposures.
    The petitioner explains that the Angel Shield uses \1/2\-inch lead 
walls that completely encapsulate the radiopharmaceutical. The 
petitioner further explains that the entire administration process is 
mechanized. This removes the occupational worker from direct and 
immediate contact with the radioactive substance. As a result, 
radiation exposure rates are substantially and immediately reduced.
    The petitioner contends that the reduction of unnecessary radiation 
exposure when administering radiopharmaceuticals by injection is of 
critical importance as the practice of nuclear medicine evolves toward 
therapeutic applications and the administration of medium and high-
energy radiopharmaceuticals. The petitioner states that the one of the 
NRC's primary duties is to establish regulations on the safe use of 
nuclear materials. The petitioner contends that prohibiting the hand-
held administration of radiopharmaceuticals by injection and requiring 
the use of the Angel Shield makes the administration of 
radiopharmaceuticals safer and furthers the goals of ALARA by reducing 
occupational dose rates.

The Petitioner

    The petitioner has been a nuclear medicine technologist for over 
twenty years and has been exposed to radiation on a recurrent daily 
basis. He invented a radioactive substance administrator, the Angel 
Shield, to protect himself and others from unnecessary radiation 
exposure when administering radiopharmaceuticals by injection.

    Dated at Rockville, Maryland, this 17th day of August, 1999.

    For the Nuclear Regulatory Commission.
Andrew L. Bates,
Acting Secretary of the Commission.
[FR Doc. 99-21792 Filed 8-20-99; 8:45 am]
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