[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]
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