[Federal Register Volume 67, Number 2 (Thursday, January 3, 2002)]
[Proposed Rules]
[Pages 274-275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-72]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 67, No. 2 / Thursday, January 3, 2002 / 
Proposed Rules  

[[Page 274]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

[Docket No. PRM-35-15]


Jeffery C. Angel; Denial of Petition for Rulemaking

AGENCY: U.S. Nuclear Regulatory Commission.

ACTION: Petition for rulemaking: denial.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is denying a 
petition for rulemaking submitted by Jeffery C. Angel (PRM-35-15). The 
petitioner requested that the NRC amend its regulations concerning the 
medical use of byproduct material to prohibit the hand-held 
administration of radiopharmaceuticals by injection. In addition, the 
petitioner requests amendments to require the use of the ``Angel 
Shield'' instead of the currently used syringe radiation shields. The 
NRC is denying the petition because it would be inconsistent with the 
Commission's overall program for revising its regulatory framework for 
the medical use of byproduct material, to make requirements more risk-
informed, more performance based, and less prescriptive.

ADDRESSES: Copies of the petition for rulemaking, the public comments 
received, and the NRC's letter to the petitioner are available for 
public inspection or copying in the NRC Public Document Room, One White 
Flint North, 11555 Rockville Pike, Room 0-1F23, Rockville, Maryland 
20852. These documents are also available on NRC's rulemaking website 
at http://ruleforum.llnl.gov. For information about the interactive 
rulemaking website, contact Carol Gallagher, (301) 415-5905, email: 
[email protected].

FOR FURTHER INFORMATION CONTACT: Gary Comfort, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, (301) 415-8106, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

The Petition

    On August 23, 1999 (64 FR 45907), the Commission published in the 
Federal Register a notice of receipt of a petition for rulemaking filed 
by Jeffery C. Angel. The petitioner requested that the NRC amend its 
regulations concerning the medical use of byproduct material (10 CFR 
part 35) to prohibit the hand-held administration of 
radiopharmaceuticals by injection. The petitioner also requested the 
amendment of 10 CFR 35.60(c), ``Syringe shields and labels,'' to 
require the use of the ``Angel Shield,'' designed by the petitioner, 
instead of the syringe radiation shields currently in use. The 
petitioner believes that recent improvements in technology, 
specifically the invention of the Angel Shield, support the need to 
require its use by all NRC licensees when preparing or injecting 
radiopharmaceuticals in patients or human research subjects.
    In his supporting information, the petitioner contends that the use 
of the Angel Shield instead of the currently required syringe radiation 
shield would reduce radiation exposures by:
    1. Eliminating hand-held injections of radiopharmaceuticals.
    2. Completely encapsulating the syringe within the administrator, 
providing 360 degrees of protection.
    3. Shielding 100 percent of low energy (140 Kev) and 88 percent of 
high energy photons (511 Kev).
    4. Allowing for the remote administration of the 
radiopharmaceutical.
    5. Reducing the number of missed injections and subsequent multiple 
exposures.
    The petitioner supports his contention by stating that he has been 
a nuclear medicine technologist for over 20 years and has been exposed 
to radiation daily, using the traditional syringe radiation shield. The 
petitioner invented the Angel Shield to protect himself and others 
administering radiopharmaceuticals by injection. He states that other 
syringe radiation shields are neither designed nor engineered according 
to sound radiation protection principles.

Public Comments on the Petition

    The NRC received five comment letters. Three comment letters 
opposed the petition. Two of these were from certified health 
physicists and consultants in the area of radiation protection, and one 
was from an industry trade association. Two comment letters supported 
the petition. One of the letters is from a certified nuclear medicine 
technologist and the other is signed by five radiology physicians.
    One commenter stated that the petition cannot be justified in terms 
of cost-benefit, and that the petitioner failed to demonstrate that 
current exposures were excessive, thus presenting a significant risk to 
workers. Two commenters stated that the petition is self-serving in 
that it would provide a monopoly for the petitioner, as he is the only 
manufacturer of the Angel Shield. Another commenter said that licensees 
should be able to decide what procedures and equipment are necessary 
for the practice of their ``as low as reasonably achievable'' (ALARA) 
programs. One commenter said that prohibiting hand-held injections 
would adversely affect the practice of medicine, while another 
commenter stated that existing radiation syringe shields have been in 
use for many years without compromising worker or patient safety.
    A commenter supporting the petition stated that the majority of her 
occupational exposure as a nuclear medicine technologist came from the 
injection of radiopharmaceuticals and their preparation. The commenter 
contends that lowering radiation dose rates is more than enough 
justification for granting the petition, stating that this device will 
make her profession safer. The commenter also stated that unless the 
device is mandated, employers would not spend the money to provide 
adequate protection to achieve ALARA objectives.
    The other commenters in favor of the petition cite NRC Regulatory 
Guides 8.10 and 8.29 in support of their conclusion that the 
petitioner's device clearly furthers the objective of reducing 
occupational exposures as far below the specified limits as is 
reasonably achievable. According to these commenters, the Angel Shield 
should simply be viewed as a new, better, and safer syringe radiation 
shield than the ones currently employed and required pursuant to 10 CFR 
35.60(c). These commenters also assert that the new

[[Page 275]]

technology would permit the rejection of the antiquated practice and 
the unnecessary exposure associated with hand-held injections.

Reasons for Denial

    Based on consideration of the petition and public comments, the NRC 
is denying the petition because it would be inconsistent with the 
Commission's overall program for revising its regulatory framework for 
the medical use of byproduct material. This framework focuses 
Commission regulation on those medical procedures that pose the highest 
risk, structures its regulations to be more risk-informed and more 
performance-based and significantly reduces regulatory burden in many 
areas, consistent with NRC's ``Strategic Plan for Fiscal Year 1997--
Fiscal Year 2002,'' cited in ``Medical Use of Byproduct Material; 
Policy Statement; revision,'' 65 FR 47654 (August 2, 2000).
    The amendment the petitioner seeks would be contrary to this 
regulatory approach by prohibiting the hand-held administration of 
radiopharmaceuticals by injection and/or requiring the use of a 
specific shield (the Angel Shield). Licensees should have the 
flexibility to determine what kind of syringe or vial shields to use in 
order to meet the requirements contained in 10 CFR 20.1101, ``Radiation 
protection programs.'' This regulation requires licensees to use 
practical procedures and engineering controls designed to achieve doses 
that are ALARA (as low as reasonably achievable). In its inspection 
program, the NRC assesses whether licensees have complied with these 
requirements. Denial of this petition does not prohibit the licensee 
from using the ``Angel Shield'' or other shields, as practicable to 
meet these requirements. However, if this petition were granted, it 
would limit the flexibility of licensees to use other, including more 
effective, strategies to meet ALARA without additional rulemaking.
    The decision to deny the petition is consistent with our 
performance goals. There is no impact on public health and safety, the 
environment, or common defense and security. Use of the requested 
device is not essential to limit or minimize doses to the public, 
workers, or patients. Public confidence should not be affected because 
the existing regulations require licensees to minimize doses and this 
decision continues to allow licensees the flexibility to use the 
``Angel Shield'' or other strategies, as best fits their individual 
practices, in achieving this outcome. The decision maintains the 
effectiveness, efficiency, and realism of the current regulations. 
Lastly, the denial decision does not impose unnecessary regulatory 
burden on licensees or the NRC staff, whereas granting the petition 
would cause undue burden by imposing prescriptive criteria on 
licensees.
    For reasons cited in this document, the NRC denies the petition.

    Dated at Rockville, Maryland, this 18th day of December, 2001.

    For the Nuclear Regulatory Commission.
William D. Travers,
Executive Director for Operations.
[FR Doc. 02-72 Filed 1-2-02; 8:45 am]
BILLING CODE 7590-01-P