[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  

[[Page 49298]]


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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]
BILLING CODE 7590-01-P