[Federal Register Volume 71, Number 160 (Friday, August 18, 2006)]
[Proposed Rules]
[Pages 47751-47752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13632]
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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. 71, No. 160 / Friday, August 18, 2006 /
Proposed Rules
[[Page 47751]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 36
[Docket No. PRM-36-01]
American National Standards Institute N43.10 Committee; Denial of
Petition for Rulemaking
AGENCY: U.S. Nuclear Regulatory Commission.
ACTION: Denial of petition for rulemaking.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is denying a
petition for rulemaking (PRM-36-01) submitted by the American National
Standards Institute N43.10 Committee. The petitioner requested that the
NRC amend its regulations to provide relief from the requirements to
have an operator present onsite whenever an irradiator is operated
using an automatic product conveyor system and whenever product is
moved into or out of the radiation room when an irradiator is operated
in a batch mode. In addition, the petitioner requested relief from the
requirement to have a person who has received training, described in
the regulations, on how to respond to alarms onsite at a panoramic
irradiator where static irradiations (no movement of the product) are
occurring.
ADDRESSES: Copies of the petition for rulemaking, the public comments
received, and NRC's letter to the petitioner may be examined at NRC
Public Document Room, Public File Area Room O1F21, 11555 Rockville
Pike, Rockville, MD. These documents also may be viewed and downloaded
electronically via the rulemaking Web site.
The NRC maintains an Agencywide Document Access and Management
System (ADAMS), which provides text and image files of NRC's public
documents. These documents may be accessed through NRC's Public
Electronic Reading Room on the Internet at http://www.nrc.gov/reading-rm/adams.html. If you do not have access to ADAMS, or if there are
problems in accessing the documents located in ADAMS, contact the NRC's
Public Document Room Reference staff at 1-800-397-4209, 301-415-4737,
or by e-mail to: [email protected].
FOR FURTHER INFORMATION CONTACT: Thomas Young, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, telephone: (301) 415-5795, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
The Petition
On September 15, 1998 (63 FR 49298), the NRC published a notice of
receipt of a petition for rulemaking filed by the American National
Standards Institute N43.10 Committee. The petitioner requested that NRC
amend 10 CFR 36.65(a) and (b). These regulations require that:
(a) Both an irradiator operator and at least one other individual,
who is trained on how to respond and prepared to promptly render or
summon assistance if the access control alarm sounds, shall be present
onsite:
(1) Whenever the irradiator is operated using an automatic product
conveyor system; and
(2) Whenever the product is moved into or out of the radiation room
when the irradiator is operated in a batch mode.
(b) At a panoramic irradiator at which static irradiations (no
movement of the product) are occurring, a person who has received the
training on how to respond to alarms described in Sec. 36.51(g) must
be onsite.
The petitioner suggested revisions to require that:
(1) The operator and at least one other trained individual would be
present onsite whenever it is necessary to enter the radiation room;
(2) An individual trained to respond to alarms would be available
and prepared to promptly attend to alarms, emergencies, or abnormal
event conditions at any time the irradiator is operating;
(3) If the individual is not onsite, automatic means of
communication would be provided from the irradiator control system to
the individual and the irradiator control system would be secured from
unauthorized access and the console key would be secured from removal
from the control console when the individual is not onsite;
(4) Inspection and maintenance for operability of the automatic
communication system be completed; and
(5) A definition be provided in 10 CFR 36.2 for the term,
``onsite.''
Currently a licensee is required to maintain adequate coverage on
all shifts of a continuously operating panoramic irradiator facility.
However, the petitioner believes that based on domestic and
international operating experience with panoramic irradiators, there is
no significant benefit to safety from having the operator and an
additional trained individual onsite as opposed to an individual being
available to respond promptly from an offsite location. The petitioner
believes the current cost for a licensee to employ individuals for
continuous operation of the facility has a substantial impact on the
expense associated with conducting business. The petitioner believes
that revising the requirements as suggested above would result in cost
containment without a reduction in safety.
The petitioner believes that recent improvements in communications
technology support the design of automated alert systems to provide
offsite warning to an individual who could then respond through
technologies such as pagers, cell and land-line telephones, remote
process control monitoring, etc. The petitioner believes that remote
response to alarms could require only slightly longer response time
than if the responder were onsite.
In its supporting information, the petitioner recognizes that
during emergencies and abnormal events, human intervention is required
to evaluate the situation and determine whether actions need to be
taken and what specific action is required. The petitioner believes
this evaluation can take place remotely, between the irradiator and an
individual offsite. The petitioner also supports its position by
stating that European irradiators of similar design and characteristics
to those in the United States have had no incidents that can be traced
to the practice of unattended operations.
Public Comments on the Petition
The notice of receipt of petition for rulemaking invited interested
persons to submit comments. The NRC received
[[Page 47752]]
one comment letter from the Manager of Technical Services, State of
Ohio's Bureau of Radiation Protection. The commenter was generally in
favor of granting the petition. However, the commenter noted that the
problem with remote communication systems is that they are likely to
fail or become overloaded under extreme conditions, although the
probability of having two remote incidents (irradiator and
communication systems) occurring at one time is highly improbable for
the unattended operation of a panoramic irradiator. In addition, the
commenter suggested that an onsite security guard or other non-operator
personnel could be trained to summon assistance as required without
needing the operator. The comments were considered in the development
of the NRC's decision on this petition.
Reasons for Denial
The NRC is denying the petition for the following two reasons:
1. In February 1993, the NRC amended its regulations to add 10 CFR
Part 36, ``Licenses and Radiation Safety Requirements for
Irradiators,'' to specify radiation safety requirements and licensing
requirements for the use of licensed radioactive materials in
irradiators. After the rule became effective, the NRC received numerous
licensee event reports that described failures or non-functions of
source mechanisms and related systems that needed intervention by
personnel who had received training described in the regulations on how
to respond to alarms. The information reported to the NRC from 1990 to
2006 about events at irradiator facilities indicates no reduction in
the number of events or the nature of events. The NRC determined that
the data on events do not support the petitioner's request or indicate
that the requirements should be revised. Rather, the NRC continues to
believe that there is a need for individuals to be onsite to evaluate
and respond to such emergencies, as well as to ensure day-to-day
radiation safety.
2. The NRC does not believe that reliance on an automated
communication system to notify a remote human operator via an
electronic mechanism provides the same level of safety as currently
provided by an onsite operator and/or a second individual who is
trained to respond to irradiator alarms. This issue was previously
raised in comments on the proposed rule for 10 CFR Part 36. The
Statements of Consideration (SOC) for the final rule (58 FR 7715;
February 9, 1993) state that, for 10 CFR 36.65, ``a considerable number
of comments objected to the proposed requirements as excessive.'' A
commenter suggested that an irradiator with an automatic conveyor
system should be able to operate with only an operator present and an
automatic telephone dialing device for responding to alarms. Another
commenter suggested that the irradiator should be able to operate
unattended but with an automatic telephone dialing device. The SOC
state that the NRC did not accept either suggestion because the NRC
believed that automatic conveyer systems have enough malfunctions to
require that an operator be present at the site. In addition, the NRC
believed that the operator should have some backup in case of problems.
The petitioner has not provided a sufficient basis from which to
conclude that this NRC judgement is no longer correct. Specifically, no
new information has been provided by the petitioner that would warrant
revising the existing regulations. The existing NRC regulations provide
the basis for reasonable assurance that the common defense and security
and public health and safety are adequately protected.
For the reasons cited in this document, the NRC denies this
petition.
Dated at Rockville, Maryland, this 4th day of August, 2006.
For the Nuclear Regulatory Commission.
Luis A. Reyes,
Executive Director for Operations.
[FR Doc. E6-13632 Filed 8-17-06; 8:45 am]
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