[Federal Register Volume 63, Number 178 (Tuesday, September 15, 1998)]
[Proposed Rules]
[Pages 49298-49301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24714]
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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. 63, No. 178 / Tuesday, September 15, 1998 /
Proposed Rules
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 36
[Docket No. PRM-36-1]
American National Standards Institute N43.10 Committee; 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 the
American National Standards Institute N43.10 Committee. The petition
was docketed as PRM-36-1 on June 25, 1998. The petitioner requests that
the NRC amend its radiation safety requirements for irradiators to
allow the operation of panoramic irradiator facilities without
continuous onsite attendance.
DATES: Submit comments by November 30, 1998. 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: David L. Meyer, Office of
Administration, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001.
You may also provide comments via the NRC's interactive rulemaking
website through the home page (http://www.nrc.gov). This site provides
the availability to upload comments as files (any format), if your web
browser supports the function. For information about the interactive
rulemaking website, contact 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
20555-0001. Telephone: 301-415-7162 or Toll Free: 800-368-5642 or e-
mail: DLM[email protected].
SUPPLEMENTARY INFORMATION:
Background
The NRC's current regulations at 10 CFR 36.65 (a) and (b) describe
how an irradiator must be attended during operation. The regulations
specify 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. 35.51(g) must be
onsite.
The petitioner states that at the time this regulation was
published (February 9, 1993; 58 FR 7715), the intent was to ensure that
appropriately trained personnel were available to provide prompt
response to emergencies or abnormal event conditions that could occur
during the operation of a panoramic irradiator. The petitioner further
states that based on case histories of accidents at panoramic
irradiators and on the potential for automatic conveyor systems to
malfunction, the regulation was designed to ensure that individuals
responding to an abnormal event be physically located at the irradiator
site to render assistance promptly.
The Suggested Revisions
10 CFR 36.65 (a) and (b)
(a) Both an irradiator operator and at least one other individual,
who is trained on how to respond to alarms as described in
Sec. 36.51(g) and prepared to promptly render or summon assistance,
shall be present onsite whenever it is necessary to enter the radiation
room.
(b) At least one individual who has received the training on how to
respond to alarms described in Sec. 36.51(g) must be available and
prepared to promptly respond to alarms, emergencies, or abnormal event
conditions at any time a panoramic irradiator is operating. If the
individual is not onsite,
(1) Automatic means of communications must be provided from the
irradiator control system to alert the individual to alarms,
emergencies, or abnormal event conditions. As a minimum, the automatic
communication system must alert the individual to those emergency or
abnormal events listed in Sec. 36.53(b);
(2) The irradiator control system must be secured from unauthorized
access at any time an irradiator operator is not onsite. This security
must include physically securing the key described in Sec. 36.31(a)
from being removed from the control console.
10 CFR 36.61(a) ``Inspection and Maintenance''
(17) Operability of automatic communications systems used to alert
individuals to alarms, emergencies, or abnormal event conditions if
required by Sec. 36.65(b)(1).
10 CFR 36.2 ``Definitions''
Onsite means within the building housing the irradiator or on
property controlled by the licensee that is contiguous with the
building housing the irradiator.
Grounds for Request
The petitioner states that the current requirements dictate that
personnel be employed to maintain adequate coverage on all shifts of a
continuously operating panoramic irradiator facility. However,
according to the petitioner, based on both domestic and international
operational experience with these large irradiators, there is no
significant benefit to safety from having an individual onsite as
opposed to being available to respond promptly from an offsite
location.
In addition, the petitioner states that the number of personnel
required to operate and safely manage an irradiator has a substantial
impact on the expense associated with conducting business, that
personnel expenses in salary,
[[Page 49299]]
benefits, insurance, training, and affiliated costs must eventually be
passed on to customers. The petitioner offers that employing a minimal
number of employees without compromising safety provides an opportunity
to optimize cost containment without eroding the facility's financial
ability to maintain operations.
Supporting Information
The petitioner states that panoramic gamma irradiators are designed
to require minimal or no operator intervention with the system to
continue routine operations following start-up. The petitioner notes
that although the current regulations require the operator and other
individuals to be onsite during routine product processing, their
involvement with the irradiator controls or safety systems is minimal
while the product is being irradiated during normal operations. The
petitioner asserts that human intervention is required only during
emergencies or abnormal events. Controlling the response to emergencies
and abnormal events, such as those listed in 10 CFR 36.53(b) according
to the petitioner, requires intervention by the operator or other
appropriately trained personnel to evaluate the situation and determine
whether actions need to be taken and what specific action would be
required. The petitioner believes that the need to have individuals
physically present onsite during operation is governed by the potential
need to respond to emergencies and abnormal events.
The petitioner states that at the time part 36 was published, the
best method for alerting individuals to emergency or abnormal event
conditions was considered to be audible and visible alarm systems that
would annunciate within the facility, and that individuals responsible
for responding to the alarms would be onsite to answer the alarms
promptly. However, the petitioner notes that with recent improvements
of communications technology, including wireless communications, and in
continuing improvements in process control technology, alerting an
individual to an abnormal event in an operating system does not have to
rely solely on audible and visible signals within the facility to
ensure that the alert is made. The petitioner offers that automated
alert systems can now be easily designed to provide an offsite alert to
an individual available to respond promptly through technologies such
as pagers, cellular telephones, land-line telephones, remote process
control monitoring, or other methods. If the offsite individual,
according to the petitioner, is located so as to be available to
respond promptly, response to alarms could require only a slightly
longer time than if the individual were onsite.
The petitioner notes that the irradiator operator makes the first
response in the event of an emergency or abnormal event. Under the
conditions of the current regulations, the implicit assumption is that,
during evening or night shifts when the facility management or the
Radiation Safety Officer (RSO) are not assumed to be present, the
irradiator operator would respond to the alert and assess the
situation. The petitioner states that in typical emergency procedures
for panoramic irradiators, one of the first responsibilities of the
irradiator operator responding to an alert, is to notify the RSO of the
condition, and to rely on the RSO or facility management to provide
specific instructions to take in responding to the emergency.
Therefore, the initial response by an irradiator operator onsite during
an abnormal event would be to secure the irradiator against entry and
notify the RSO or other responsible party.
The petitioner states that for response to any emergency situation,
appropriate actions must be taken to prevent individuals from entering
the radiation room while the sources are unshielded (i,e., to prevent
personnel exposures) and to protect the sources from damage. The
petitioner lists the 10 emergency and abnormal event conditions
identified in 10 CFR 36.53(b) for which a licensee must implement
procedures to address. These are: (1) Sources stuck in the unshielded
position; (2) Personnel overexposures; (3) A radiation alarm from the
product exit portal monitor or pool monitor; (4) Detection of leaking
sources, pool contamination, or alarm caused by contamination of pool
water; (5) A low or high water level indicator, and abnormal water
loss, or leakage from the source storage pool; (6) A prolonged loss of
electrical power; (7) A fire alarm or explosion in the radiation room;
(8) An alarm indicating unauthorized entry into the radiation room,
area around pool, or another alarmed area; (9) Natural phenomena,
including an earthquake, a tornado, flooding, or phenomena as
appropriate for the geographical location of the facility; and (10) The
jamming of automatic conveyor systems.
The petitioner states that 10 CFR part 36, subpart C specifies the
design features of a panoramic irradiator that address most of the
items from the list in terms of preventing personnel exposures and
damage to the sources during an abnormal event. Specifically, the
petitioner states that access control system as described in 10 CFR
36.23 will prevent unauthorized entry and protect against personnel
exposure (item 2 on the list). In 10 CFR 36.39, the conveyor system
must automatically be stopped if the exit radiation monitor detects a
source (item 3). Sources must be returned to the shielded position and
access controls maintained during a prolonged loss of electrical power
as described in 10 CFR 36.37 (item 6). A fire protection system
designed to meet the requirements of 10 CFR 36.27 will cause the
sources to return to the shielded position in the event a fire is
detected, thereby protecting the sources from fire damage (item 7).
Unauthorized entry to the radiation room must, under 10 CFR 36.23 (a)
cause the sources to return to the shielded position (item 8). If an
automatic conveyor system jams, the source rack protection required by
10 CFR 36.35 ensures that some cause other than interference with the
source rack is the cause of the jam, which will allow the sources to be
safely returned to the shielded position (item 10).
The petitioner contends that in the remaining abnormal event
conditions listed in 10 CFR 36.53, appropriate response to the
conditions would not necessarily be required immediately. That is,
responding to the event would entail some evaluation of the conditions
before deciding the proper actions to take. The petitioner believes
that having individuals onsite to respond to these conditions would not
present a substantive improvement in safety over having the same
individual offsite, but available to respond promptly. In particular,
the petitioner notes that sources stuck in an unshielded position (item
1 from the list), while potentially causing damage to the product being
irradiated if it cannot be independently removed from the radiation
room, do not present an immediate threat to personnel, provided the
access control system operates in accordance with the 10 CFR 36.23
design requirements. Nor does a stuck source rack, in and of itself,
pose a threat to the integrity of the sources. Similarly, detection of
a leaking source (item 4) would not require quicker action than could
be provided by an offsite individual, as long as the water circulation
system is automatically stopped to prevent accumulation of contaminants
in the water treatment and filtration system. Water level alarms (item
5) and natural phenomena (item 9) would not present an immediate hazard
requiring onsite assistance, provided that the radiation
[[Page 49300]]
room access control system is operating properly.
Therefore, the petitioner contends that in considering the design
requirements for panoramic irradiators and the potential emergency or
abnormal event conditions that are addressed in procedures as well as
facility design, response by the licensee would not be substantively
impaired if the individual responding to the alarms were not located
onsite. The petitioner states that automated communication system using
current technology would provide adequate protection of personnel and
source integrity by alerting an offsite person who is able to respond
promptly.
In considering the potential impacts from the proposed rule change,
the petitioner cites that European nations permit unattended operation
of irradiators, as requested in this petition. The petitioner states
that these irradiators have similar or identical design characteristics
to those operating in the United States, in terms of the safety and
monitoring systems, as well as in product conveyance. The petitioner
notes that there have been no incidents at these irradiators that can
be traced to the practice of unattended operations.
NUREG-1345
Review of Events at Large Pool Irradiators
The petitioner notes that in reviewing information notices issued
to irradiator operators by the NRC over the past several years that
none of the events described in the notices occurred during unattended
operations. However, the petitioner notes that NUREG-1345, entitled
``Review of Events at Large Pool-Type Irradiators,'' which summarizes
45 events at Category IV irradiators, specifically mentions three
events that occurred during unattended operations. They were:
1. Failure of Pool Water Purification System at RTI, Rockaway, NJ,
September 22, 1986.
2. Product Conveyance Jam at Johnson & Johnson, Sydney, Australia,
November 13, 1982.
3. Contaminated Water Spill at International Nutronics, Inc.,
Dover, NJ, December 31, 1982.
The petitioner provides a paragraph summarizing how each event
occurred. The petitioner states the situations prompting the first two
events (i.e., low water level and product conveyance system jam) are
listed in the abnormal event procedures required under 10 CFR 36.53(b).
The petitioner offers that under the proposed revision described in
this petition, both instances would require notification of the offsite
individual. In the first event, there were no offsite consequences or
threats to worker or public health and safety, although continued loss
of pool water could have presented shielding problems inside the
irradiator. In the second event, approximately 15 hours passed between
the initiating event (conveyor jam) and the fire, which would have
allowed more than adequate time for response and mitigation had the
offsite individual been promptly notified.
The third event that occurred during unattended operations resulted
not from the irradiator operation, but from operation of a pool water
clean-up system. Under existing regulations, attendance during this
operation would not be specifically required.
Analysis of Events and Lessons Learned
The petitioner notes that in the ``Analysis of Events and Lessons
Learned'' section of NUREG-1345, Category IV irradiator events are
grouped into several types and that to evaluate whether the proposed
regulatory revision is adequate to protect worker and public health and
safety, the potential consequences of each type of event under
unattended operations as described in this petition must be examined.
The petitioner states that of the event types listed in NUREG-1345,
those described as management deficiencies are not directly related to
attendance during operations. That is, the presence of individuals
onsite during operations would have no relevance to mitigating
potential consequences of management deficiencies, except as may be
related to system problems with the irradiator itself.
The petitioner asserts that events stemming from system problems
are the most likely type of event that would have adverse consequences
from unattended operations and that in NUREG-1345, this type of event
is subdivided into: (1) Access control systems; (2) source movement and
suspension; (3) encapsulation; (4) pool leakage and pool purification
system; and (5) miscellaneous systems. The petitioner notes that in
considering whether mitigation of these types of events would be
compromised by not having the irradiator operator onsite, the most
serious potential consequences would be the failure of the access
control systems. The petitioner notes that in NUREG-1345, three of the
four events involving the access control system resulted from systems
that either were not operating properly or were not designed to meet
the criteria as currently specified in 10 CFR part 36. The other event
involved an interlock design defect that was corrected through wiring
modification.
Unauthorized Access to the Irradiator
The petitioner argues that if the irradiator access control system
is designed to meet the requirements of 10 CFR 36, that the primary and
backup access control systems will ensure that inadvertent entry to the
irradiator is not possible, even under conditions of unattended
operation. In addition, the petitioner states that the existing
regulations require that the key used to operate the irradiator be the
same key used to open the door to the radiation room and that only one
such key be in service at the facility. The petitioner proposes in the
suggested amendments that physically securing the key from removal
would provide an additional layer of protection against unauthorized
access to the irradiator.
Other Type of Irradiator Events
The petitioner believes that response and mitigation of other type
of events described in NUREG-1345 would not be greatly improved by
having an onsite individual to respond as compared to the individual
being offsite, but able to respond promptly. For example, source racks
stuck in the unshielded position typically require several hours or
days to correct; that mitigative and corrective actions in such
instances would be accomplished by a team of individuals and would not
be done solely by the two people required by the existing regulations
to be onsite. The petitioner believes that the small additional delay
resulting from an individual offsite being the first to respond to such
an abnormal event would not have a discernible effect on the adequacy
of response.
As another example, the petitioner states that NUREG-1345 lists
several events that resulted in fires in the irradiator, that might be
considered to have important consequences for unattended operations.
The petitioner states that events in which there was an initiating
event from the irradiator system involved a significant time interval
between the initiating event, usually a stuck source rack, and the
fire. In those events, according to the petitioner, the time delay
ranged from approximately nine hours to eleven days, which would allow
adequate time for an offsite individual to respond and summon
appropriate assistance. The petitioner notes that properly designed
source rack protective barriers, as required under 10 CFR 36.35
minimizes
[[Page 49301]]
the probability of having a source rack become stuck from product or
carrier interference, which further reduces the fire potential in
irradiators designed in accordance with 10 CFR 36 part criteria.
Conclusion
The petitioner concludes that the consequences of Category IV
irradiator events described in NUREG-1345 would not be increased under
the conditions proposed in this petition. The petitioner believes that
having an offsite operator with automatic communication capabilities as
described in this petition would not appreciably diminish response to
and mitigation of abnormal events or emergencies, and would not
compromise safety of either the workers or the general public.
For the Nuclear Regulatory Commission.
Dated at Rockville, Maryland, this 8th day of September, 1998.
John C. Hoyle
Secretary of the Commission.
[FR Doc. 98-24714 Filed 9-14-98; 8:45 am]
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