ML20058F993
| ML20058F993 | |
| Person / Time | |
|---|---|
| Issue date: | 09/14/1990 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| REF-10CFR9.7 NUDOCS 9011090282 | |
| Download: ML20058F993 (36) | |
Text
- - --
l 4
- /pt E80g**c, UNITED STATES es,
.g j
NUCL E AR R E GU L ATOR Y COMMISSdGN.............
WASHINGTON D.C. 20$b5 RELEASED TO THE POR
\\,',,,.*
September 14, 1990,
//k/90 orner or Twt
''''''''''' M i
sicRtim
*eese j
MEMORANDUM FORT.
James M. Taylor fp Executive Director for t'; gations
)
FROM:
Samuel J. Chilk, Secrets b
SUBJECT:
SECY-90-211 - PROPOSED RUi E FOR LICENSES AND 1
RADIATION SAFETY REQUIREMINTS FOR LARGE IRRADIATORS The Commission (with all Commissioners agreeing) has approved publication of the notice of proposed rulemaking to obtain public comments on a new Part 36 on licenses and radiation safety requirements for large irradiators subject to the attached revisions and the following comments.
The Statement of Consideration should clearly indicate that investigstion of cesium Waste Encapo lation and Storage Facility (WESF) capsules is continuing and thsa the Commission may reconsider their use when the results or other pertinent information becomes available.
Accordingly, the Federal Recister notice should be revised specifically to acknowledge the potuntial.need for such reconsideration and to solicit public comment on whether the Commission should allow continued use of sources containing soluble cesium-137.
The need for rule section of the Federal Racister notice should include a summary of relevant lessons learned from the RSI-Decatur accident.
The summary should briefly describe how the proposed rule addresses the lessons discussed in Enclosure 6 of SECY-90-211 that are relevant to the proposed rule (e.g.,
items 1, 3, and 6-10).
State Programs staff should prepare a suitable response to the t
issue of Agreement State licensing, which is relevant to the proposed rule because it-bears on the Commission's decision to require the States to-adopt compatible regulations.
The remainder of the text of the Statement of Consideration should be' T
reordered appropriately.
SECY NOTE:
THIS SRM, SECY-90-211 AND THE VOTE SHEET OF COMMISSIONER CURTISS WILL BE MADE PUBLICLY AVAILABLE 10 WORKING DAYS FROM THE DATE OF THIS SRM gj O 90o934 i
g PT9.7 PDC
4-i 4 '
In order to maintain consistency among the various Parts of the regulations dealing with byproduct material licensing with respect to provisions on employee protection and completeness of information, sections 36.7 and 36.9 should be deleted.
To make it clear that an irradiator licensee must comply with provisions addressing these matters in Part 30, the following should be added as the last sentence of section 36.1(a):
In particular, the provisions of Parts 19, 20, 21, 30, 71 &
170 of this chapter apply to applications and licenses subject to this Part.
(EDO)
(SECY Suspense:
10/26/90)
In addition, the Commission believes the Interim Report of DOE's Type B Investigation Board and any records of the WESF source testing performed to date should be requested from DOE as soon as possible.
Staff should assemble a review panel composed of individuals who represent the full range of appropriate expertise and who have not been directly involved in decisions affecting the licensing of WESF sources.
The panel should review DOE's findir3gs and report to the Commission with an assessment of the implications of these findings and recommendations regarding the continued commercial use of the WESF sources.
(EDO)
(SECY Suspense:
12/17/90)
The review panel recommendations an6 all related public comments on the rule should form the basis Isr recommended changes to the proposed final rule which address the matter of continued licensability of sealed sources containing readily soluble or dispersible material.
(EDO)
(SECY Suspense 3/25/91) commissioners Rogers and Remick think that staff's discussion regarding ability to pay for recovery operations is confusing (page 3 of enclosure 6).
The result is a perception that the specific issue raised in the cleanup of the RSI accident was not considered relative to this rulemaking.
This confusion should be addressed in the final rulemaking.
In addition, the staff should review the current priority for
-rulemaking to address financial assurance for cleanup of
a
)
s
. acciderats, not just for large irradiators, but for all materials licensees with the potential for significant accidental contamination.
(EDO)
(SECY Suspenset 3/25/91)
Attachments:
As stated cc Chairman Carr Commissioner Rogers Commissioner Curtiss Commissioner Remick OGC GPA T
-. ~
(7590-01) o IV.
Radiation Protection Philosophy.
V.
Reference Documents.
VI.
Public Meeting VII.
Summary of the Proposed Requirements and The Rationale for Their Inclusion.
VIII. Other Considerations.
- Ix A,.ewerit Ate ce@'W)'
3 MX.
Finding of No significant Environmental Impact:
Availability.
Xf, Paperwork Reduction Act Statement.
XIT.
Regulatory Analysis.
XIII. Regulatory Flexibility Certification.
XIV. *i44t Backfit Analysis.
X % % Mt. List of Subjects.
XVI. Wording of the Proposed Amendments.
I.
Large Irradiators Irradiators u'e gamma radiation to irradiate products to change their characteristics' in some way.
Irradiators are used for a variety of purposes in research, industry, and other fields.
Irradiators covered by this proposed rule are those large enough to deliver a dose exceeding 500 rems [ rads) (5 sieverts [ grays)) in one hour at a distance of one meter.
The proposed rule does not cover se'.f-contained irradiator devices in which the volume being irradiated is '.otally inaccessible to people.
Irradiators use eith;c radioactive materials or electronic machines (x-ray machines or accelerators) to produce very high radiation dose levels.
The NRC and Agreement States regulate irradiators using radio-active byproduct materials.
Electronic machine irradiators are regulated 3
[7590-01)
^
Licenses for the Use of Panoramic Dry Source-Storage Irradiators, Self-Contained Wet Source-Storage Irradiators, and Panoramic Wet Source Storage Irradiators," that was published in January 1985.
However, the scope of e '
4 the guide is limited, and many subjects are not covered or are covered in a way now considered obsolete.
On subjects that are not covered in the regulations or guide or for which there are no criteria on what is acceptable, the applicant has no way of knowing what will be accepted.
Similarly, the license reviewer may be uncertain about what should be required.
If the license reviewer considers the application incomplete or inadequate, he or she sends a " deficiency letter" to the applicant i
explaining what additional information is needed.
Review of the applica-4 tion is not resumed until a written response from the applicant has been received.
This can substantially delay issuance of a license.
(it-is possibie-and-desirabie-to-formatire-the-requirements-for licensing-ierge-f rradiators-by-way-of-raiemaking:--Reiemaking-has-the l
advantage-of pubiicly-stating-the NRes requirements:--Thes--the-require-ments governing-isrge-feradiators-shoeid-be-eisar-and-be-consistentiy-and l
uniformiy-appifed-) Thus, although the safety requirements and policies are generally understood and agreed upon, they are contained in regula-gg tions, a regulatory guide, and specific licensing c'onditions.
This rule W
would! clarify [andstandardizetherequirementsforcurrent'!;;;;;;0and
- rt :.ti;;;;t:d ;r;/..'. in ind..try : d ;_'d ;';; tr' ; :: : 9tg i
ft:f'itf:: ; i: rrr; t 'f::::f ; :t:-d:rd i futu#e. ired 4 tog; A rule would also make the NRC's licensing reviews and inspections more efficient.
If requirements are clearly stated in a rule, license applications could be shorter because there would be no need for appli-cants to describe what they would do in areas covered by the rule.
The 9
l
[7590-01)
NRC could then issue licenses with fewer license conditions.
Inspections would be more efficient because there would be a uniform set of require-i ments.
(The-uniform requirements of-a-reie-aise previde-a-strenger-basis fer-enforcement-because uniform-wording-shocid acquire-a eniform-inter-pretation-)
At present, aside from the specific requirements in S 20.203 on access control, many requirements are those committed to by the applicant in its license application.
The wording of similar requirements can vary slightly from licensee to licensee.
This makes the NRC inspector's job more diffi-cult because he or she must determine precisely what each licensee is committed to doing.
There are at this time a number of new large irradiators either under construction or planned.
In addition, Congress has appropriated money in support of the construction of six food irradiators.
Thus, a significant expansion in irradiator operations is expected.
Developers of these new facilities may not be familiar with NRC requirements.
A rule would help make NRC's. requirements clear to people building new irradiators.
There are also some areas in which either technology is changing (such as computer controllers) or NRC policy is evolving (such as quality assurance).
A rule can provide a comprehensive and up-to-date i
these areas that would be consistently and uniformly applied.
U 4 Mon g,;g g,
In addition, there were lessons learned from a leakina source accident 4 Mhri that occurred at an irradiatorfin 1988.[ Ihat accident is discussed in NRCl h
@rt NUREG-1392, Leakage of an Irrap tor Source--the June 1988 Georgia Whiletherehavebeen!atleastthreepreviousinstancesof RSI Incident."
leakina sources at irradiators, the essons learned from the 1988 accident l
reinforce the need for bein0 prepa d to detect and cope with leaking u
t i
\\
! L Se d A. Summey d 10 Endeswee (,
y y
[7590-01) c.
J Isources.
Therefore, the proposed rule requires a means to detect leaking sources, a water-tight pool on pool-type irradiators, procedures for detect-f ing and dealino with radioactive contamination if it is found, training for
)
operators in those procedures, and notification of NRC if contamination is found.
The cause of the leak is still being actively investigated.
When the cause of the leak is discovered, there may be additional lessons learnedy f
The rule will be a matter of compatibility between the NRC an:i the Agreement States, thereby providing consistency between Federal and State safety. requirements. With regard to basic radiation standards and defini-tions, as found in 10 CFR Part 20, which have been identified as strict 94.m ot t Q matters of compatibility with respect to Agreement State regulations, in AW this area the Agreement States are expected to adopt essentially an
& IX.
identical standard.
However,[with-regard-to-non-stendards/ definitions on retaset yg, etees--the this rule while being a matter of compatibility between the 2
Cs y d NRC and the Agreement' States is assigned a level of compatibility which 2
would allow the Agreement States to adopt additional [ mere-stringent specific] requirements based on local concerns or experience.
III.
Review of Operating Experience To develop a basis for these proposed safety requirements, the NRC reviewed the operating experience of large irradiators.
The information
~
presented in this section is taken, in large part, from " Review of Events at Large, Pool-Type Irradiators," Eugene A. : Trager, Jr., NRC Office for 11
[7590-01)
Analysis and Evaluation of Operating Data, NRC Report NUREG-1345, 1989.
(Copies of NUREG-1345 may be purchased through the U.S. Government Print-ing Office by calling (202) 275-2060 or by writing to the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20013-7082.
Copies may also be purchased from the National Technical Information Service, U.S.
Department of Commerce, 5285 Pe Royal Road, Springfield, VA 22161.)
A.
Radiat4 n Overexposures Se tous radiation overexposures involving irradiators occurred in the d.S. in 1974 and 1977.
Fatalities were caused by radiation over-exposures involving irradiators in Italy in 1975 y in Norway in 1982; o.nd 'm Et Sivder %
M1H.
In 1974, in New Jersey, an operator at a panoramic irradiator walked into the radiation room containing an exposed source, saw it, and quickly left the room.
He received a dose large enough to cause clinically observ-able symptoms of radiation sickness, but the dose was not large enough to be fatal.
The entrance to the room lacked the modern automatic access con-trol systems now used and an alarm system had been turned off.
The operator did not follow the proper procedures for entry.
It is possible the operator was not sufficiently vigilant because he was working alone at a late point in his shift.
The operator made the error on the twelfth hour of the fourth straight day in which he worked 10 to 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />.
In 1977, a worker at an another irradiator in New Jersey was over-exposed to radiation after he entered a radiation room while a 500,000-curie (18-x-1922] (1.8 x 101s. becquerel) cobalt-60 source was unshielded.
The licensee was in the process of modifying the irradiator and was operating the-irradiator while the interlocks on the door used to i
(7590-01]
automatically cause the source to become shielded upon entry if the pri-mary door or barrier were passed, and (3) there was no alarm system to alert the person entering that the source was exposed.
In addition, several NRC operational requirements were not met.
In total, at least i
six levels of protection in NRC's current and proposed requirements were not provided.
(The accident is described in more detail in "The Radia-tion Accident at Institute for Energy Technology, September, 1982, Some Technical Considerations," Leiv Berteig and Jon Flatby, The Journal of Industrial Irradiation Technology, Volume 2, pages 309-319,1984.)
(art on 8DN B.
Other Operating Problems Y
[ Trager s-report) NUREG-1345 identified forty-five events at U.S.
l irradiators of which forty-four had some actual or potential safety significance.
Only two of the events had actual rather than potential impact on the health and safety of the employees or the public.
Of the forty-four events, thirty-one involved the failure, malfunction, or degradation in the performance of some irradiator system.
These systems include:
access control, source savement mechanism (movement and suspension); source encapsulation; and pool or cleanup system.
An addi-tional ten events stemmed from managew nt deficiencies.
Three events involved natural phenomena and other. site problems.
1.
Access control.
Two radiation overexposures involving access control were discussed in Section III. A. and will not be discussed further here.
Both events occurred prior to implementation of NRC's current access control regula-tions in Part 20.
A third event, ' eported in 1978, also involved the 14
.. j O
The most recent fatality resulting from an irradiator exposure occurred in El Splvador in 1989.
A movable rack holding a 18,000-curie (6. 60 x 10 '-becquerel) cobalt-60 source was jammed in an unshielded position.
An operator bypassed safety systems and entered the irradiation chamber, along with two helpers, to free the rack and lower the source back into a 1
storage pool.
The three workers were exposed to high doses and
)
develcped acute radiation syndrome.
Although prompt medical attention was effective in countering the acute effects, the legs of two of the men had to be amputated.
Six months after the accident, the operator died as a result of radiation-induced lung damage which was complicated by a lung injury sustained during treatment.
(summarized from Croft, J.,
Zuniga-Bello, P.,
and A.
Kenneke, 1989, "The Radiological Accident in San Salvador,"
I!.EA General Conference:
Scientific Programme for Nuclear Safety, September 28, 1999) 10$6CI OU pee.vious R$$'
- - - ~
- - - ~ ~
~
~ ~ ~
'~ '
(7590-01) access control system.
It was discovered that failure of two door inter-lock switches would allow the source to move from the safe storage to the exposed position even if the door to the radiation room was open.
2.
Source movement.
There were thirteen eve aat involved interference with source movement and six other events that involved the source suspension cables.
weft.
There vestinsufficient data to specify a cause for five of the thir-3 teen events in which source movement was impeded.
In six of the thirteen events, the product carriers interfered with the movement of the source rack.
In one of those, the interference was indirect; a box pusher cylin-der created a short in a control circuit resulting in the tripping of a circuit breaker in the control circuit.
The source then properly began lowering itself into the shielded position.
But loss of the control circuit caused the loss of the source-down position sensor, and so the source cable drum continued to rotate and raised the source to the up position before the motor stalled.
The source had to be lowered manually.
There were two source-movement events involving loss of source movement capability that had unique causes.
At a research irradiator, interference between an experiment and the source impeded movement of the source.. Low temperatures at another irradiator caused freezing that j
appears to have been responsible for preventing movement of the source.
The thirteen events involving source movement'were benign in that lL no. radiation exposures resulted.
But two of the events caused fires inside the radiation room.
Two events resulted in individual sources
+
1 coming loose from the source rack.
One event resulted in distortion of the source rack.
15
[7590-01) d bI
[An-event-in] The previously mentioned 1988 event involved the leak-age of a cesium-137 source.
This resulted in the release of about 10 curies (3.7 x 10" becquerels) of cesium-137 to the pool.
The event led to concerns that contaminated products might have been shipped from the plant.
[However) Although no contamination was found on products that had been [ shipped] distributed to the public, contamination was found on products that had been shipped to a warehouse and in workers' houses and a car.
4 Pool or cleanup system.
There were three events that involved pool leakage or pool cleanup system leaks.
In the case of the leaking pool, the existence of a high rate of water loss from the storage pool was noted by an NRC inspector during an inspection.
After discussions with the NRC, the licensee agreed to repair the leak and monitor the rate of pool leakage, i
There were two events involving leaks in pool water purification systems.
In one event, the piping on the discharge side of the purifica-tion system pump leaked.
Contributing factors were that the piping was suitable for cold temperatures _while the pool water temperature was 120'F andthatthejointshadrecentlybeentorqued.
The leak developed when the irradiator was shut down for the weekend and there was apparently no low pool level shut-off on the purification pump.
In the second event involving a pool purification system leak, a pipe broke.
Contaminated water spilled into the facility and some ran out of the building.
Small amounts of contamination were later found on the ground outside of the building.
t 17
- ~ _ -
)
hhdad proc 4dgres WMd k AValla.Mt. h (7590-01]
inspcten 6e nkeente. docte$ M li+y e M ea & n, l
hwwec, and a time consuming and unnecessary license amendment.
This could unneces-ihe Sah4Y d sarily hamper fac'llity operation. ^gocumentationonchangesinprocedures g
Wi4 havt is mest be retained for inspection by the NRC for three years (9 36.81(d)).
x The application must describe the responsibilities and authorities of the radiation safety officer and other management personnel.
The applicant must also describe the qualifications of the radiation safety officer.
These are standard requirements used to judge whether the appli-cant's personnel are qualified to handle radioactive materials safely.
Consideration was given as to whether the proposed rule should contain specific requirements for the qualifications of the radiation safety officer.
Requirements could be placed on:
the amount of f]rmal radiation safety training, the amount of on-the-job training, the length and type of previous experience, and the amount of formal education.
It was decided not to specify minimum qualifications in the rule because tnere is so much variability in qualifications among people who would be adequate to do the job.
Instead, it was decided that guidance on qualifications should be included in a Regulatory Guide and that the NRC license reviewer should make the final determination of adequacy based,
on the actual qualifications of a specific individual.
This would allow the licensee reviewer the flexibility to consider the strengths and weaknesses of.a specific individual in making the determination.
Applications to operate panoramic irradiators must contain logic
-diagrams of access control systems.
Applications also must contain information on how sealed sources would be tested for leakage and contamination.
The applicant must submit information on loading and unloading sources.
If the applicant intends to load and unload sources, the-I 26
[7590-01]
The door or barrier that series as the primary access control system i
must have controls that would (1) prevent the source from being moved out of its shielded position if the door or barrier were open and (2) cause l
the source to return to its shielded position if the door or barrier were opened while the source was exposed.
The backup access control system must be able to detect entry while the source is exposed.
If entry is detected, the system must (1) auto-matically cause the source to return to its shielded position and
)
(2) activate audible and visible alarms.
In addition, the proposed rule would require a radiation monitor in the radiation room of panoramic irradiators to detect radiation when the source is indicated to be in the fully shielded position.
The radiation monitor would have alarms and an interlock on the personnel access door.
This is a new requirement not in the existing i 20.203(c)(6).
The purpose is to provide an additional level of protection in case of some failure of the source movement mechanism combined with a failure of the operator to make the required radiation survey upon entry into the radiation room.
The phrase currently used in i 20.203(c)(6) concerning reduction of radiation levels upon entry is worded so that an individual could not receive "a dose in excess of 100 mrem in one hour." This requirement has been changed in S 36.23 to state that the time for the sources to return be. kss beg oc qua.l 4e to the shielded position mustg ;t r:: # the time that it would take a person entering the radiation room to walk to the edge of the pool (wet-source-storage) or into the beam (dry-source-storage).
This wording more directly states the intent of the requirement.
If necessary, the licensee could use a time-delay mechanism to delay opening the door after unlocking it.
30
(7590-01]
O The access control requirements apply to each entrance of the radia-tion room of a panoramic irradiator whether intended for personnel access or intended only for product entrance or exit.
Panoramic irradiators with a conveyor system could meet the requirement by providing clearances around the conveyor carriers that are too small to allow someone to pass through.
The requirement is that the door or barrier must prevent inadvertent entry.
The purpose of this requirement is to prevent a rea-sonably prudent person from carelessly, inattentively, or accidentally entering the radiation room while the source is exposed.
an indL96ndent Theaccesscontrolsectionwouldrequire4backupaccesscontrol system on panoramic irradiators.
The backun system could use photo-electric cells in an entrance maze, pressure mats on the floor, or similar means of detecting a person entering the radiation room while the source is exposed.
The purpose of the backup system is to provide a redundant means of preventing a person from being eccidentally exposed to the source. 'In case of a failure of the interlocks on the door or bar-rier combined with a failure to follow operational procedures, the backup system should warn the person entering the radiation room of the danger and automatically cause the sources to return to their shielded position.
The system must also alert another person of.the entry.
That person must be prepared to render or summon assistance.
This provision [impiieitiy) l prevents the operation of the panoramic irradiator without a second person being available to render or summon assistance.
The section explicitly states that the irradiator may not operate if the requirements of the section are not met.
This section also contains requirements for underwater irradiators.
i For example, the pool must be within an area surrounded by a personnel access barrier with an intrusion alarm when the facility is not operating.
31
[7590-01)
Ifanirradiatorweresubjecttoalargeearthquake,thepotential i
damage of radiological significance would be to the integrity of its concrete shielding.
Analyses of reinforced concrete irradiator shields l
designed to meet generally accepted building code requirements for rein-forced concrete have shown they are inherently quite robust and resis-tant to damage from moderate-size earthquakes.
To protect against large earthquakes, the NRC decided to include requirements that radiation shields in seismic areas be designed to retain their integrity after a large earthquake.
Also, all irradiators must have an emergency procedure for earthquakes, j
$1~ET
[B--Wee-of-casion-sources The-two-radionociides generally-esed-in gamma-irradiators-are 5
)
cobait-66-and-cesion-ig--Eobait-60-is-in-the-form-of-solid-metaipeliets that-are-reistively-insolubie-in-water --Eesine-ia7;-on-the-other-hand;-is gene ra t iy-encap s ni ated-as - a-s ei t;- c e s i ne-c hi o ri de;- that-i s - f ai riy-s ei nbi e in-water --Therefore;-cesine-157-comid-be-mere-dispersible-than-cobait-68 1
if-the-sealed-source-leaked-or-was-damaged:--The question-considered-is shoeid-use-of-cesium-iS7-sources-shosid-be-permitted-st-aii-er permitted only-with-certain-additional-restrictionst ee, RSI ta bezahq Georg%
i n-1988;- a-c osine-iSF-s ourc e g-stzy i rra di atorzi esked: -No-radiation exposures-in-excess-of-NR6As-iinits-occurred;-but-the-iesk-raised-a ques-tion-aboot-the-integrity-of-cesium-187-seerees:--As-oz
@ -the eanse-of-the-leak-is-not known-and-is-stili-being-actively-investigated; intends 40. One.Veduta.
f 7
The-NRE4 Q whether-cesine-187-secreesjare-suitable l
Nato $s,
%.:ti;eti: 5 c r % te; *tf=4 hee,,,
V fe as -
4
- i n
- tintia diece. O. nri;r ;r ri:7 G M s d tb r 9 --* ~ er t h4 Cowdesien fpcIMea.O[
or gealed sources conhiting ftadily O %c comme,nt en I'M 8P 5
k vnaMtr,
)
gersiht. medecial
. ~ _ _ _ _ _. _ _ _. _ _. _
(7590-01)
( p
-use-might-net-be permitted:--On-the-ether-hand;-if-the their shows-that-the-leak was-an-iseisted-failure-enlikely-to-ocent-again;-there might-be-no-restrictions-en-the use-of-cesins:--The-resciution-of-this y
issee-most-be-deferred entii-the-rescits-of-the-investigation-are-evaiiabler)
-y y
i L
Seismic Detection and Resistance As a related issun to sitina, NRC considered requirements for a seismic detector whose activation automatically causes the source to return to its_
1 fully shielded position.
Such a requirement is contained in the ANSI Cate-cory IV Standard and is general practice.
However, the detectors and tour _ce_
return mechanism would not improve the safety of large irradiators because shield walls must be desianed to provide adequate shielding to protect workers and the general public in the event of a seismic event.
There-fore, NRC concluded that such a requirement is not necessary to protect the public health and safety.
Public comment is specifically requested on the need for a seismic detector and automatic source return mechanism.
t l
C.
Decommissioning i
The NRC considered whether special design requirements were needed to L
facilitata decommissioning of the facility.
The NRC concluded that the h
requirements in the proposed rule are adequate to facilitate decommission-p L
ing. ' Normally, decommissionina is relatively simple, because there would be no radioactive contamination present in the facility.
However, concam-ination could be present if leakage of the sources did occur.
[The-high quali ty-and-i ntegri ty-of-the-s eat ed-s earce s -makes-s i gni fi c an't-i e skege-f rom l-the-secrees-anlikely).
17, leakage from sources did occur (;-however;) the periodic leak tests of dry-storage sources and monitoring of the pool water L
58
}
b
[7590-01)
H.
Issuance of a Regulatory Guide The NRC plans to develop a regulatory guide that will set forth the information that an irradiator license applicant should provide in its license application.
Development of the guide will begin after public comments on the proposed rule have been reviewed.
NRC intends to issue the guide in draft form for public comment before the final irradiator rule becomes effective.
The guide would replace the draft irradiator licensing guide now in use.
yX.
Finding of No Significant Environmental Impact:
Availability The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart n of 10 CFR Part 51, that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and therefore an environmental impact statement is not required.
The proposed
. action codifies in a rule the licensing requirements and policies on large irradiators.
[Since-t]The proposed action is-directed to improving the regu-latory, licensing, inspection, and enforcement framework relating to these-irradiators[--it) and will not affect the quality of the human environment.
The environmental assessment and finding of no significant impact on which this determination is based are available for inspection at the NRC Public Document Room,: 2120 L Street NW.
Lower Level, Washington, DC.
Single copies are available-wi+,hout charge upon written request from NRC Distri-bution Section, Office of Information Resources Management, U.S. Nuclear Regulstory Commission, Washington, DC 20555.
62
[7590-01)
XI _ Paperwork Reduction Act Statement This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.),
l This rule has been submitted to the Office of Management and Budget for review and approval of these requirements.
l The total recordkeeping and reporting burden for this collection of 1
information is estimated to average 750 hours0.00868 days <br />0.208 hours <br />0.00124 weeks <br />2.85375e-4 months <br /> per licensee per year, includ-L ing the time for reviewing instructions, searching existing data sources, h
L gathering and maintaining the data needed, and completing and reviewing the b
i collection of information.
However, this does not represent an increment due to this regulation; the burden is already imposed on licensees because of license canditions and other requirements.
Send coments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Information and Records-[end-Reports) Management Branch, Division of Information Support Services [/fRM), Office of Information [ Administration-and) Resources Man-agement, U.S., Nuclear Regulatory Commission, Washington,_DC.20555; and to
?
the Paperwork Reduction Project (3150-
), Office of Management and Budget, a
Washington, DC 20503.
4
-XII. Regulatory Analysis i
The Commission has_ prepared a draft regulatory analysis on this pro-posed regulation.
The analysis compares the costs and benefits of the requirements in the rule with current licensing requirements.
The draft 3
analysis is available for_ inspection in the NRC Public Document Room, 4
=
[7590-01) 2120 L Street NW., Lower Level, Washington, DC.
Single copies of the analysis may be obtained without charge upon written request from:
Oistribution Section, Office of Information Resources Management, sSNRC, I
Washington, DC 20555.
Comments on the analysis may be submitted to the NRC as indicated under the ADDRESSES headina.
[As-indicated previensiy--the-Eemmission-is partieniariy-interested-in receiving-publie-eemments-en-the-regulatory-analysis-)
XIII. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b),
the Commission certifies that this rule, if adopted, will not have a signifi-cant economic impact upon a substantial number of small entities.
' Currently, there are roughly 70 to 80 irradiators that are large irradiators, as defined by the proposed rule.
Of those irradiators, there i
are currently 39 irradiators in the U.5, with sources greater than 250,000 curies (9 x 1015 becquerels) up to a maximum of 30,000,000 curies (1.1 x 1018 l
'mcqperels).
Fifteen are licensed by NRC; 24 are-licensed by Agreement s.cte s.
Five additional irradiators are either under construction or pro-posed for construction in Agreement States.
In addition, the NRC licenses 10 irradiators with sources smaller than 250,000 curies (9.25 x 1015 becquerels) that would be subject to the rule.
The Agreement States probably have about twice as many of these " smaller" large irradiators.
Thus, the total number of facilities that would ultimately be affected by the rule is-roughly 70 to 80.
All the irradiators use cobalt-60 except for four which L
use cesium-137.
In addition to these irradiators, Congress has appropriated 1
money to the U.S. Department of Energy to support the construction of six 64 i
=v--
-M-'
w&*=
c
[7590-01)
C (c) How the proposed regulations could be modified to take into account the entity's differing needs or capabilities; (d) The benefits that would be gained or the detriments that would be avoided by the licensee if the proposed regulations were modified as suggested; and
'(e) How the regulation, as modified, would still adequately protect the public health and safety.
The comments should be sent to the Secretary of the Commission, U.S.
Nuclear _ Regulatory Commission, Washington, DC 20555, ATTN:
Docketing and Service Branch.
XI\\/.
% Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this proposed rule and therefore that a backfit analysis is not required for this proposed rule.
The proposed rule does not involve any provisions that would impose backfits as defined in 10 CFR 50.109 (a)(1).
X V.
%WE ListofSubjects L
l-10 CFR Part 19 Environmental protection, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Penalty, Radiation protec-tion, Reporting and recordkeeping requirerents, Sex discrimination.
Byproduct material, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and 66 d
[7590-01)
XVI. Wording of the Proposed Amendments For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt 10 CFR 36 and make the conforming amendments to 10 CFR Parts 19, 20, 21, 30, 40, 51, 70, and 170.
1.
Part 36 is added to 10 CFR Chapter I to read as follows:
l l
Part 36 - Licenses and Radiation Safety Requirements for.arce Irradiators
(
Subpart'A - General Provisions Sec.
i 36.1 Purpose and scope.
l.'
36.2 Definitions.
36.5 Interpretations.
L36.7 Employee Protection.
36.8
'Information collection requirements:. OMB approval.
36.9 Completeness and Accuracy of Information.
Subpart B - Specific Licensino Requirements 36.11 Application for a specific license.
l 36.13 Specific licenses for large irradiators.
36.15
' Start'of construction.
1:
l:
36.17 Applications for exemptions.
i 36.19 Request for written statements.
l 68 l
/-
[7590-01) e J
L
$ 36.23 Access control.
(a) Each entrance to a radiation room at a panoramic irradiator mustL have a-door or other physical barrier to prevent inadvertent' entry of per-sonnel while the sources are exposed.
It must not be possible to move the sources out of their shielded position if the door or barrier is open.
Opening the door or barrier while the sources are exposed must cause the sources to return to their shielded position.
The time for the sources to be less San or ept 40 return to the shielded position mustpt :::::^ the time that it would take a person starting to enter the radiation room to walk to the edge of the
. pool or into the beam (as [ appropriate] applicable for irradiator type).
The primary entry door must have a lock that is operated by the same key-used to move the sources.
The doors and barriers must not prevent any individual in the radiation' room from leaving.
(b) In addition, each entrance to a radiation room at a panoramic an inkeendent irradiator must have backup access control to detect personnel entry while 3
the_ sources are exposed if the primary access control fails.
Entry while the sources are exposed must cause the sources to return to their fully shielded position and must also activate a visible and audible alarm to make theikdividualenteringtheroomawareofthehazard.'Thealarmmustalso alert at'least one other individual who is on site of the entry.
That indi-vidual shall be; trained and prepared to promptly render or. summon assistance.
(c) A radiation monitor must be provided to detect the presence of radiation in the radiation room of a panoramic irradiator before personnel entry.
The monitor must be integrated with personnel access door locks to prevent ~ room access when the monitor detects high radiation levels, malfunc-tions', or is turned off.
The monitor must generate audible and_ visible alarms if high radiation levels are detected when personnel entry is 79
--+
v
[7590-01) if offsite power is lost or if a component of the return mechanism fails.
The design must allow for accomplishing the return without causing radiation overexposures of personnel.
(j) Seismic.
For panoramic irradiators to be built in seismic areas, the licensee shall design the reinforced concrete radiation shields to retain their integrity in the event of an [fer-the-maximam-credibie) earthquake j
l
[fer-the-area--as-estabiished-by) by designing to the seismic require-ments of an appropriate source such as ACI Standard 318-77, " Building Code Reouirements for Reinforced Concrete," or local building codes, if current l
l
[er ether-appropriate-seerees-)
L S 36.41 [Quelity-assurance-in)Constructionkontrol.
9 The requirements of this section must be met for [by) irradiators whose construction begins after leffective date of the rulel.
The requirements I
of'this section must be met prior to loading sources.
(C Shieldino.
For panoramic irradiators, the licensee shall monitor the construction of the shielding to verify that its construction meets design specifications and generally accepted building code requirements for reinforced concrete.
(b) Foundations.
For-panoramic irradiators, the licensee shall moni-l tor the construction of.the foundations to verify that their construction meets design specifications.
(c) Pool-integrity.
For pool irradiators, the licensee shall verify that the pool meets design specifications and shall test the integrity of l
the pool.
The licensee shall verify that penetrations and water intakes meet the requirements of 8 36.33(b).
88 wm
+-
y 7
>[ -! !
' ' '((
i e
2 L! G )
3:
Y'u-
.p y I
f,4 -
.e
,k-
['s 7
DRAFT C0tCPFSSIONAL LETTER
++
Dear.Mr. Chairman:
SCnY IThe Commission has ;:t:' t: r;;r;:
a',to the Office of the Federal
=ad "
q g
M Register for publication the enclosed proposed amendments to the Commission's s
y.y'1" rules.
The amendments would create a new Part 36 on radiation safety and j
L1icensing' requirements for.large irrasiators.
Ninety days will be allowed for y
~ public comment.
i L.
- Irradiators use gamma radiation to irradiate' products and change their
. characteristics. in some way.
Most irradiator capacity is now used to steril-ize dispos'able medica 1Lproducts.
Most of the remaining. capacity is.used in
.j chemical processing.
There is currently.little irradiation of food, which
~
-would be for:the purpose of destroying pests or prolonging shelf-life, but
~
Congress has appropriated mon'y to:the Department of Energy'to support the e
p construction of six-irradiators for use in-food processing.
There are currently about 70 to 80 irradiators.in the U.S.: t'at would: ultimately h
r 1
be affected by the rule.
Some are licensed and; inspected by NRC'and others by t
J Agreement States ~
i a
+
j
= Commercial irradiators have been licensed since 1964.
While the safety require-i
- ments.and polic'ies are generally understood'and agreed upon,'they are contained
-.ma.
l i
L.
d i
P r
yr.
i e
g y-y s
4 y
w
.. u 4,
4_
l e Como\\l W Lj in regulat ons, a': regulatory guide, 'and specific licensing conditions.
This rule would clarify, standardize-and update the requirements for current Md
'i.....; n n.: ; p p r: =ti:fp:t:d gr:::th i-the 4-d"d y; futuct. irradidors,
S Sincerely, i
Eric S. Beckjord, Director Office of Nuclear Regulatory Research
Enclosure:
- Federal' Register Notice I
I t
l L
l i.
l l
l't ii A
b
\\
t r
d' l<
2.
. _ ~ -
'Y NRC CONSIDERS REGULATION FOR LARGE IRRADIATORS g
i
?
L' The Nuclear Regulatory Commission is considering changing its regulations y
to,specify radiation safety and licensing requirements for licensees who use j
radioactive materials in large irradiators, g
The primary use (85% percent) of large irradiators is to sterilize' dis-posable medical products,and supplies such as rubber gloves and syringes.
Most of. the remaining. irradiations are -for chemical processing--mainly to change the-f c'homical characteristics of plastics.
~
L Irradiators that would be covered by the NRC's proposed rule are of three types:-
l(1): Panoramic, wet-source-storage iri adiators--sealed " sources" a
containing radio' active materials (usually cobalt-60) are submerged in a water Lstorage poo_1.and are fully shielded when not in use.
Irradiations occur by-moving.the sources;out of water and into the air, and then moving products to lbe irradiated past the sources.
i (2) Underwater irradiators--the sealed sources are'in a water storage
-pool at all: times,= and' the products to:be irradiated are lowered into the
+
water.'.
J (3): Panoramic,- dry-source-storage-irradiators--the sealed sources are stored:in a shield constructe' of solid materials.and are fully shielded when d
not in-use.
Irradiations occur in air-.
f Lar irradi tors are' urrently icensed nder the eneral equir ment T of.th regulat ns of th RC or A eement S tes (whi are ates at ave
'g as ed aut ity, the gh. agree nt with e.NRC, er th icen ng radioacti materia withini e state) nd lice e conditions.
The proposed Lrule:would formalize and codify the specific conditio'ne equirements would
~
include:
Commacde.Ilcrediehm h&H. been II'4M8d #UWfa 'IN N O' #"
kN"6ON "
P
.nay,ay aew na.y=6 e., *y.= = tan =1 in 70 Ldatt., clari$wi*
tawu,a
' Ad $geciA lktq adiWns. %o pioned ruit. we*U %s demdardine.
'and Mdakt, % gascaments l
fcc ounnt and 4vhet. irradiatm, (,'"#' 4 L
1 e
\\
't
.I 1
_t :
?
_Irradiator. operator training; Written operating and emergency procedures; Leak testing of-the sealed radioactive material sources; Doeble~ encapsulation of sealed sources installed after the effective date-of the rule; Access controls to prevent inadvertent personnel entry into a e
e' radiation room at a panoramic irradiator while the radioactive sources are exposed; Limits on ra'diation dose rates in normally accessible areas; e'
Radiation monitors and surveys; Reports to the NRC if radioactive material sources are leaking or stuck in an unshielded position, the pool liner becomes degraded or p
.certain'other conditions occur; and l
. Safety requirements for design and construction.
Approximately 70 to 80 large'irradiators would be affected by the rule.
m,___.
.n.__m
__m..,.._
_..a a
~'
)
i Interested persons.'are invited to submit written comments on the proposed' regulations by (90 days after'the publication in the Federal' Register on
).
The comments should be addressed to.
1 the= Secretary of the Commission, U.~S. Nuclear Regulatory Commission, i.
Washington,-DC 20555,. Attention:
Docketing ar;d Service Branch, l
!1 f~
y, Ut, 1
1 b_
l dome, ort. Iltan$ed and ifrJpe.ched by k N anci M r5
)
?
L k
Agreement 5+3.+es (wuch ace. e +ee d at b e.
- ll, At$amed Ja.aborHy, Acough greernent with klRL, avec NL li k(.t.n4mh = ofradicadivt.-
tedecIt{s wiMn M Mes).
t p,
)
't i
i l-2
.r
~
9c e!
L DRAFT ENVIRONMENTAL ASSESSMENT AND FINDING OF 4
NO SIGNIFICANT IMPACT s
ON.
PROPOSED AMENDMENTS-TO CFR " LICENSES AND RADIATION SAFETY REQUIREMENTS FOR LARGE IRRADIATORS" Office of Nuclear Regulatory Research U.S. Nuclear Regulatory Commission
. November 1989 I.
THE PROPOSED ACTION is to develop p g i L.,ged M es a.ede A d (
vThe. proposed action 1 4x"f licensing and w
radiation safety. requirements for the use of licensed radioactive materials for.
o large irradiators.
This action is called the "rulemaking" option in this
^ environmental assessment.
froP06M Irradiators:use: gamma radiat on to irradiate products to change their C
characteristics in some way.. The licensing and safety requirements would apply
]-
.to large panoramic irradiators?(t ose in which the mater.ial being irradiated is in air in a room that is accessible to personnel when the source is shielded)
D+
and'cartain~ 1arge underwater irradiators in which the source always remains
[
~
. shielded under water and-the product-is:irradiatedLunderwater. V The rule would l>
L" noticover self-contained. dry-source-storage irradiator devices, instrument cali-h.
.brators, medical.' uses of: sealed sources (such as. teletherapy),
nondestructive testing.(such as industrial-radiography).
[
II.- NEED~ FOR. THE' PROPOSED RULEMAKING ACTION L
Large irradiators are currently licensed primarily under: -(1)the
' general provisions-of.10 CFR 30.33, which requires: that " equipment and
. facilities are adequate"/ and that'the. " applicant isl qualified by training and -
experience;'F(2) the' general; requirements of Part '20, for example, ' dose limits L
- and the need for " adequate" surveys; and (3) the specific requirements of-n.
10 CFR 20.203(c)(6)-.and (7) that: deal with access. control-requirements for pano-ramic. irradiators.
There is also a: draft regulatory guide FC 403-4, " Guide for
'the' Preparation of Applications for Licenses for the Use of Penoramic Dry-Source-Storage Irradiators, Self-Contained Wet Source-Storage.Irradiators, and Panoramic Wet Source-Storage Irradiators, that,was published in January 1985.
I~ '
h However, the scope of the guide is: limited, and'many subjects-are not covered-
- or_ are covered in' a =way now considered obsolete.
On subjects that are not-L' 1
- covered:in. the regulations:or guide or for which there are no criteria on what
. is. acceptable,: the applicant has no Lway of knowing what wil? 5e accepted.
Simi-p
. larly.-the;. license reviewer may be uncertain about what should be required.
.. If the license reviewer con'siders the application incomplete or inadequate, l
he or she-sends a:" deficiency letter"'to the applicant explaining what additional p
% icediakes us. Oose.ceble. f clelivering o. dose grade Oa.n
[
Soo 3.m m one, b e 4
o.
- Mspace, of one me.k' from Se soore.e., ebber - in de oc Web e gregri.A 6 L
L %61% of -irradiator.-
~
3".,
j 1
",;3
-(
g ". ' '
.y
,linformation is needed., Review of the application is not resumed until a'wri.tten' response'from the applicant has been received.
This can substantially delay; issuance of a license.
)
c TW. jr:90 sed
'(
Although the safety requirement and policies are generally understood h
.and_ agreed upon, they are contained n regulations, a regulatory guide, and L
specific 1.icensing conditions. -44f rule would clarify, standardize, and L
update the requirements for current icensees and support anticipated growth in the industry.
\\
1 A rule would also make the NRC's licensing reviews and inspections more ef ficient.' 'It requirements are clearly stated in a rule, license applications
.could be shorter because there would be no need for applicants to describe 4
what they would do,in areas covered by the rule.
The NRC could then-issue licenses-with fewer' license conditions.
Inspections would be more efficient l
because there would be a uniform set of requirements.
The uniform requirements of. a rule =also provide a stronger basis for enforcement because' uniform wordingishould. acquire a uniform interpretation.
.. At:present,.aside from the specific requirements in S.20.203 on access
. control, many requirements are those committed to by the applicant in its license application.; -_The wording of similar requirements can vary slightly from-licensee l
?to licensee. This makes the NRC inspector's job more difficult because he or
- she must determine precisely what each licensee is committed to.doing..
There are'at this time a number of new large irradiators either under construction or planned.
In addition, Congress has appropriated money in sup-port ofJthe' construction of six food irradiators.
Thus, a.significant expansion in'irradiator operations is expected.
Developers of thesenew facilities may
- m not be; familiar with NRC requirements.
A rule would help make'NRC's requirements Lclear to; people' building new irradiators.
There are'also.some areas in which either technology is changing (such as
- computer controllers) or NRC policy. is evolving =(such as quality assurance).
LA rule can provide a comprehensive and up-to-date policy in these areas:that Jwould be consistently andiuniformly applied ~
ogsmied by kadi6 Ken Steedhers,.Tuci(.R4d in DaddQ W LIn addition, there were 1 ssons learned from a leaking. source accident 4
that occurred at;an irradiato in:1988.
While there have been at=least three l
1g' ' orevious instances of. leaking sources at irradiators, the lessons. learned from s
1 thelaccident reinforce the need'for being prepared to detect?and cope with' l
Kleaking? sources.
Therefore, the proposed rule requires.a means to detect:
leaking sources, a water-cight pool on pool-type irradiators', procedures for
- detecting leaks and dealing with radioactive contamination:.if'it is found, training-for operators'in these procedures, and notification.
TheErule will be' aLeatter of compatibility between the NRC and the Agreement States, thereby providing consistency between Federal and State safety requirements.
The rule'is assigned a level of compatibility which would allow the: Agreement States to adopt additional specific requirements ^ based on-local w
concerns-or experience.
2
-~
~ - -
p o
.e III.-- ALTERNATIVES TO THE PROPOSED RULEMAKING ACTION
- LThe onlyialternative -to %d rulemaking " "' "is to take nr. action at l
4 this time-and'to continue the 1icensing'and inspection process as brfore.
This E
is called the " status quo" alternative.
Th;r f;r:, 9en t;;: ;i t:r=ti ;;: m 1
- n ide,ed ;u ;.u.,, y.,,, ; Summaries. of the alternatives are provided in this section.'
r Alternative 1 4 Status quo gg g g l'
.I rnati e 1 is simply to take no ulema ing ac 'on and _ainta n the
'l tat quo.~
e imp cts-of t ing the statu quo a ernati woul be t i
co nued se-by-se lice e revie
, lic ses t t are neumb ed wi E
..9-rrespo ence c taining ommitme s, va ation' in the eview roces, an outdat crite a.
In e curre stat of,a owing i dustry, and i tici ted conti ued'gro th, this ould be a burden on both the applicants for / icen es an
,tthe NRC regulatory process, Alternative 2.- Rulemaking Alternative 2 is to adopt the proposed rule, the major requirements of which I
are summarized in this sub-section.
As-previously stated, the rule applies to large panoramicLirradiators with both dry-source and wet-source storage and l
large underwater irradiators, categories II. III and IV.respectively_-
~
M: distr ~ ~ "cre n;di: :f d:1'=rir; e d,;; great;r-W 500 r;n 't e *
- I h;;r ;t : dict:r: ;f er.e ;,etei f tt; ;;;rn, ei;,;,,,,,, e - er e;.,.; O
.ppr;; riet. ;,. ;;,. ;jpe o f :...u i. w,"- Since the proposed rule covers several
- types of, facilities, notall requirements: apply to all types of irradiators.
For example,,the safety requirements for personnel entry into' panoramic irra,
diators do.not. apply.to underwater irradiators, since the source is. underwater at'all times.
Similarly, regulations governing. source storage-pools do not.
apply to. dry-source facilities.
.,,The proposed rule specifies how and wherecto apply-for a license.
An
'I application must describelthe applicant's proposed activities,' facilities,- equip-
- ment, personnel training.'and experience, operating and emergency procedures, cand administrative = controls."
Applications'must also contain logic diagrams of access control systems, i'nformation on leak testing,-loading andLunloading of-sources. and frecuency of routine maintenance'and inspection.
In addition,
' applicants must supply any additional safety information required by the NRC.
i
~
Sealed source design.and. performance requirements are'specified by.the iruleyand are basically a= restatement of the: performance criteria contained.in
-ANSI' standard N542-1977n " Sealed Radioactive Sources, Classification," published
.by the NationaliBureau~of ? Standards in 1978-as NBS Handbook 126.
Sealed sources:
zare required to;be doubly < encapsulated.
The rule applies only to sealed-sources.
installed after,the offactive date of'the rule.
Sources installed prior to-this'
.date would have been approved'under current procedures.
1 The requirements for access control provided'in the posed rule are
- i taken largely from the existing Part 20.203(c)(6) and (c) with an attempt to simplify the;wordin. 'When the new rule is published in final form.as Part
-I 36,. sections 20.203(c) 6) and (c)(7) will be deleted.
An additional require-
- ment states -that the radiation room must have a door or other physical barrier 1
3 H
m
['
s.
oa s
e I t ', he ' +
- g
.j iu-f
- Alternative.1 is simply to take no rulemaking action and maintain the status - quo.
~ The primary impacts of - maintaining status quo
. would' be : the.. continued use of: safety requirements and policies
. contained in multiple sources for.the preparation and review of L
license applications; specific licensing: conditions for inspection
. and :- enforcement that-may vary slightly for each licenses; and outdated criteria..
This presents. a - burden to the applicant, licensee and NRC or Agreement State, and may allow for inconsistent regulatory control.
status Quo is especially undesirable when.
g considering the anticipated growth in the irradiator industry.
i i
hI
>?
Ta m g
h tous PACE i
-J; I
.f
'l i
I
,4 m.
f
.\\
i i
.(
P 4
(
.-[
l i
.l
.a.
the source has returned to its fully = shielded position.
Prior to a planned irradiation,: the operator' must inspect the radiation room, ensure that no one
' else is inside, and activate a control in the room which will, allow the sources
-to be moved.- The door must'then be locked to prevent unauthorized entry.
The irradiation of explosive or highly flammable materials is prohibited unless the licensee has obtained prior written authorization from the NRC.
Licensees are required to maintain the following records for the specified
~
-periods: a copy of the license and application must be maintained until a new
-license is issued; personnel training records for the duration of employment; current operating and emergency procedures with revisions for the previous 3 years; film badge and TLD results until the NRC authorizes disposal; radiation
. survey and' calibration records for 3 years; leak test, inspection, and mainte-nance records for 3 years; a log book listing malfunctions, irregularities, and operating problems; and an inventory of all sealed sources must be kept for the life of the. facility.
Reports to the NRC are required for the following:
theft or loss of radioactive material, events that cause or threaten overexposures, excessive radiation levels, loss of facility operation for one day or more, or property damage. greater than $2000, leaking or damaged sources, and pool contamination.
Individuals must be notified of their overexposures if they occur.
Licensees must report in writing within;5 days the following occurrencesi sources stuck in unshielded position,: fire or explosion,. damaged source racks, abnormal pool water loss, detection of radiation in exit portal, unusual radioactive contamin-ation, pool-. liner degradation,. and certain other. events.. Reports must. describe.
the event, its cause, and corrective actions to date.
IV. ~ ENVIRONMENTAL IMPACTS OF THE PROPOSED ACTION (RULEMAKING)
. 1 AND.THE ALTERNATIVE ACTION (STATUS QU0)
The environmental impacts of the proposed rulemaking alternative and the status 1guo alternative are discussed below for both. normal and accident condi-
=f tions.
Radiation exposures of both the workers and the public are considered.
l
'l A.1 Normal _ operations - external radiation..
During normal operations, the radiation dose due to external radiation
]
I outside of the shielding should not be significantly different from the. natural L
background radiation levels' present in. the area.
"t :;rr:nt?; :
i
- t; ;hi;;gj ;; p;r
- tir;;4-qg p
<---,u o m.
+q - d4-+4-- den 7;;;; ;;;;7;;;
- 7; g H
-by ra==4r
, e-d tM
- dicti:n f:n st"--!!7:rr 'n;; --dienti;;;
- =u-l~
Et--4eh '- th: :tr.;t6mJ LlMi..;:nd "-
~"
" - The.
. level of exposure would be controlled by the shielding required under
- Section 36.25 of the proposed rule; This type of requirement is identical i
(
to the-present conditions contained in the draft regulatory guide currently used for shielding of-irradiators that are already in operation.
3 s
The impact of-external radiation under. normal operations is considered to.
be negligible under both the proposed rule and the present status quo.
Although direct radiation.is the. primary impact from an irradiator facility, the impacts of direct radiation are mitigated by the requirements for shielding.
This is confirmed by personnel dosimeter records for workers currently 7
. - ~
' ~~^
~
~~
~~'~~~
^ ~ ^ ~
~
~
yy o
l,
- [ e --
hi@
~$-
(
n m c. :
k i The license application.must describe the training program for operators and hyg the qualifications of the radiation safety officer.
These would then be 4l evaluated by NRC on a case-by-case basis. - The. proposed rule also would require c
. drills of the emergency procedures (S 36.51(d)(6)).
Specialized training in decontamination would not be required because decontamination, if extensive,
.i
^
should beldone by specialists who are experienced in decontamination work
.rather than.by irradiator personnel.
Thus, the proposed rule would require j
that decontamination be done by a licensee authorized to do that type of work
_ $ 36.59(d))..
(
L
'L
- 4.
Ability to Pay for Recovery Operations yy The interim report stated, "According to information contained in RSI's y
Audited Financial Statement, the company is self-insured with respect to. general N
. liability coverage.
Whereas the specific issue of liability for the RSI incident-has not yet been determined, the recovery costs are estimated' to be in the
. multimillion dollar. category.to date.
This raises the overall question-of the h
4, ability of'the company.to pay.for remedial action and recovery operations should
~
a later decision fix. liability with RSI for.the incident."
[Inteet M nest P$6
- The proposed rule does not deal with the issue ~of a licensee's financial ability to' pay.for cleanupLof accidents.
This issue-is broader in scope, and Q(potentially concerns all radioactive material. licensees not just irra Thus, thi 1ssue hould be dealt with on a broad basis for all licensees an
[
once i toad o or only ne clas of licen ees at:a ime,'an is th efore-l Y
ou de.the cope of e irradi or rule king'whi focuse on re freme s for the's e opera on of ir diators.
he NRC-n dealin.with-thi issue has aken'th approa of d ling with b
the issue r all 1 ensees.
n June 7, 85, the RC oub shed Advan Notice'
.Propos Rulemak g (50 Feder Regist 20906.
The comment eriod f I
4 expi d on No aber 7, 5.
However, on-Dece er 15,
- 986, e Dire or of the Office Nuclear aterial Saf y and Sa guards eque ed termi ation f i
j theurule king..T termination equest's ated th "th most re onableinterf preta n" of t results of.
valve imp ct anal is i that."c erci y
r
!available fin cial mechani s are ina propt f a for he purp e of t is pro-i posed rule king." On M 2, 1987, e Executive Director for Opera ions W
' approved termination o the rulemaking O
y
- a 3
1
m a:
'4; 5
.t j'up) J '
,. )
Y'
- 4 1
4 P'
- Thus',. the NRC considered dealing with this issue' for all materials
' licensees.
On June 7, 1985, the NRC published an Advanced Notice of Proposed. Rulemakingi on " Financial Responsibility Requirements
' Applicable to-NRC Licensees for Cleanup of Accidental' and Unexpected Releases of Radioactive Materials" (50 Federal Reaister
'20906).. The comment. period expired on. November 7,
1985.
The rulemaking was terminated in 1987, however, based on the results-of a'valuelimpact analysis and-review of public comments.
NUREG/CR-4958, a'
contractor report published September 1987.
9 entitled " Impact of Proposed Financial ~ Assurance Requirements on
' Nuclear Material: Licensees,." found that suitable commercial cleanup iinsurance was not generally.available.
This report stated that, "The consensus.
view was that insurance for ' cleanup. ' and environmental restoration as=a result'of a release of radioactive materials 'was not. currently being offered by any company.
The only apparent exceptions to this view were insurance from some hospital
- q :
, activities, university research laboratories, and (perhaps) spent
. fuel-storage facilities."'
T t
n.
'a N O r
l',
,i
,s u
I
- t; v
+
i
' ^
d;
,.w
\\w 1; a w
1y ni
)
e
's j
Y
, f-:..
. fs 3 p
+;o 3s seque (Septe er;198)) contract,ar report -
UREG/CR-958,"Iyct of.Pr osed F nancial ssuran Require ts on N ear Mate al Lice fees,"
f nd that uitabl commerc'al cleanu insuranc was not nerally valiabk.
The rep t stat
".The formatio obtained rom tele one con cts (w h the
{
'insur nce in try) w consist t, and e of the ources nded t corrob-'
ora e what he othe
,had sa The co sensus vi was th insur ce for [
cleanup nd envir nmental storatio as a res t of a' lease radio ve mater is was t curre ly being fered b any com ny.
T only a arent
- ex tions t this vi were in rance fo some-ho ital tivitie, university Qesearchlaoratories,and(perhaps)spentfuelstoragefacilities."
5.
Cost Recovery l
L The interim report stated, "The RSI incident has strained the resources of all participants significantly.
Although the U.S. Department of. Energy is paying for its:own personnel and that of its contractors involved in the inci-
~
dent, the State of Georgia, U.S. Environmental Protection Agency, U.S. Nuclear Regulatory Commisiion,. Food and Drug' Administration, and. the Dekalb County -
o Public Works Department have devoted a.large amount of resources that have not been' paidifor by DOE; It.is highly probable that cost recovery will be pursued at a later date by.one or more of the participants, once-liability for the incident has been fixed."
l y
1,
"- The! question of whether cost recovery is an issue that should be consid-
?
ered in licensing.irradiator facilities is. under study, by the Conference of, _
R'adiation Control. Program Directors, Inc. and the results are not available at-I
- this time '"
~
Cost. recovery by regulatory bodies from licensees is outside the scope of this rulemaking and is not dealt with in the proposed rule.
r p
4 4
l
, -., -