[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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