ML20245D239
| ML20245D239 | |
| Person / Time | |
|---|---|
| Issue date: | 06/20/1989 |
| From: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Bernero R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 8906270025 | |
| Download: ML20245D239 (10) | |
Text
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T JUN 2 01989 MEMORANDUM FOR: Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards FR0ll:
Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety, NHSS
SUBJECT:
LESSONS LEARNED FROM THE FAILURE OF 3M STATIC ELIMINATION DEVICES Enclosed is the Lessons Learned Report from the failure of the 3M Po-210 Static Elimination Devices. This effort was initiated to examine the effectiveness of the response of NRC and the Agreement States to the problem of contamination caused by the failure of a generally licensed device. We plan to distribute the report to cognizant individuals within NRC, and file the report in the 3M file along with other documents related to the incident.
The findings for the report will be considered as part of our effort to improve regulation of generally licensed devices. The report has been coordinated with the general license re-evaluation effort, and the findings are compatible with the recommendations in the draft Commission paper on the general license re-evaluation.
Original signed by 4j 44~
Richard E. Cunningham, Direct 4r Division of Industrial and Medical Nuclear Safety, NMSS
Enclosure:
As stated l
l cc:
H. Denton, GPA l
C. Kammerer, GPA
)
E. Jordan, AE0D l
DISTRIBUTION:
NRC Central File PDR (Review Group - 3M)
IMNS Central File NMSS r/f IM0B r/f R0'Connell i
JHicked DCool JLyash JGlenn JAustin
- See previous concurrence OFC: IMDB*
- IMDB*
- IMAB*
- IMDB*
- INN 5*
- IM S
- IMN6 NAME:R0'Connell/ll:JLyash
- JGlenn :DCool
- JHicke
- RE i gh m
......_.............................................y :G ^
DATE:05/16/89
- 05/18/89:05/24/89:05/31/89:06/ /89: 6/8 /89
- 0 /
89 0FFICIAL RECORD COPY 8906270025 890620 F
PDR REVGP NRCTHMCO :
PDR l
l i
i LESSONS LEARNED FROM TH'E FAILURE OF 3M. STATIC ELIMINATION DEVICES.
l Table of Contents Page-
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4 1.0 Introduction l'
- 2. 0 Actions That Worked Well 1-3.0 Lessons Indicating the Need for Rulemaking-2' 4.0 Lessons Related to General License Policies, Licensing Procedures, or Inspection Procedures 3
- 5. 0 Additional Observations 4~
5.1 Response Actions Taken by the NRC 4
5.2 Licensing and Inspection of General Licensees 6
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'5.3 Coordination with Other Agencies 7
5.4 Changes or Additions to Regulations 7
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June 1989 i
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Contact:
R.L. O'Connell, NMSS I
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9 LESSONS LEARNED FROM THE FAILURE OF 3M STATIC ELIMINATION DEVICES
1.0 INTRODUCTION
On January 22, 1988, the Ashland Chemical Company (Ashland) reported to the NRC the presence of radioactive contamination at its plart in Easton, Pennsylvania.
The contaminatier, was believed to be coming from static elimination devices manufactured and distributed by the Minnesota Mining and Manufacturing Company (3M).
Ashland possessed the devices under an NRC general license.
The devices owed their effectiveness to polonium-210, an alpha emitting nuclide contained in tiny particles (microspheres) of ceramic material.
The contamination appeared to be caused by degradation of the devices, resulting in the shedding of microspheres or fragments of microspheres from the devices.
In followup investigations, the NRC learned that other 3M polonium-210 devices had similarly degraded, causing contamination of other industrial locations.
Actions were quickly taken to find out the extent of the problem and to effect remedial actions..The NRC issued a series of Orders is iuspeed distribution, at first suspending distribution of modelt known to be leaking ' microspheres and finally recalling all 3M devices containing polonium-210.
The purpose of this report is to document the lessons learned during the response to 3M static elimination device failures.
Suggestions for examples of lessons learned were solicited from all involved Headquarters offices and the Regional offices.
The resulting compilation of lessons included actions that worked well, changes needed in the NRC regulations, reconsideration of general licensing policy and its application, and other observations of lessons to be kept in mind but not requiring specific action at this time.
2.0 ACTIONS THAT WORKED WELL Many response actions were perceived as having been especially helpful in providing understanding, resolving problems, and promoting the objectives of all concerned parties.
These actions are identified below:
2.1 Having an early meeting with 3M to communicate the NRC's perception of the problem.
2.2 Making extensive efforts to survey licensee plants, particularly by Agreement State personnel, early in the sequence of events.
2 2.3 Requiring monthly status summaries from the licensee.
2.4 NMSS coordination of response actions in One White Flint North, which now houses the NMSS staff and most of the other Headquarters offices assisting in resolving the problem (OGC, SLITP, IP, PA).
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2.5 Coordinating reports of the results of NRC and Agreement State surveys at general licensee facilities.
2.6 Providing periodic status summaries of the event and the actions takenlor in progress to all cognizant staff.
2.7 Having devices evaluated by the NRC, independent of the licensee, to ascertain the cause of the problem.
2.8 Holding discussions between NMSS, OGC, the NRC's Regional offices, and the Office of Governmental and Public Affairs (State, Local and Indian Tribe Programs, International Programs, and Public Affairs) to assure consistency in actions such as the Orders and Confirmatory Action Letters.
2.9 Disseminating information to the states promptly through the electronic mail service of the Conference of Radiation Control Program Directors'
" Radiation Bulletin Board."
2.10 When the Order was issued recalling all 3M static elimination devices, making provision in the Order for users to keep those devices that were essential to worker safety.
A number of applications were identified where I
continued use was necessary for the elimination of static electricity in order to avoid fires or explosions.
3.0 LESSONS INDICATING THE NEED FOR RULEMAKING 1
The following lessons should be addressed in a rulemaking on general licenses (RES leadh LESSONS:
3.1 Before a license is issued authorizing distribution to general licensees, the applicant should submit a description of the system that will be used to maintain the list of general licensees to whom devices are distributed.
In addition, the product distribution reports currently required of manu-l facturers and distributors of generally licensed items should be enhanced I
to include periodic status summaries of total devices distributed, indus-tries and applications involved, and expected type of use environment.
These reports should include information for both domestic and foreign customers.
BASIS:
The 3M Company was not always able to provide an accurate listing of its users, nor was it able to identify all users having food, beverage, cosmetic, and pharmaceutical applications.
Some Agreement States (e.g., Arkansas)
3 indicated having a better kncwledge of 3M device users in their states than did the 3M Company.
- 3. 2 10 CFR 32.51 should be revised to include more detailed quality assurance (QA) requirements.
BASIS:
Some of the problems encountered with the 3M devices might have been avoided if an adequate QA program had been used during the manufacture and distribution of the devices.
3.3 The regulations should require any change in a generally licensed device to be reviewed and tested for its effect on confinement of radioactivity.
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BASIS:
Any change in the design of a device previously evaluated and approved that could increase the probability of device failure, create the possibility of accident or malfunction of a different type than previously evaluated, or reduce the margin of safety as previously evaluated, should be analyzed and verified as acceptable.
The 3M company changed the composition used in manufacturing its polonium-210 devices.
Some evidence suggests that the change resulted in poorer I
retention of the radioactive microspheres within the devices.
3M did not inform NRC of the change, and the change was not reviewed by the NRC's licensing staff.
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4.0 LESSONS RELATED TO GENERAL LICENSE POLICIES, LICENSING PROCEDURES, OR I
INSPECTION PROCEDURES The following lessons should be addressed in a study of the NRC's policies relating to issuance of general licenses and the distribution of radioactive material to general licensees (NMSS lead, in coordination with Regional l
Offices):
1 LESSONS:
4.1 Devices manufactured for distribution to general licensees should be required and demonstrated to maintain source integrity in all potential use environments, and subsequently authorized use should be limited to those uses and environments.
BASIS:
Although 3M indicated that use environments would be evaluated before its devices were leased to a prospective customer, and the customer was warned concerning use of the devices in unsuitable environments, many failures were accelerated by use in adverse environments warned against in 3M instruction sheets.
However, the principcl cause of device failure appears to have been poor design and construction.
4.2 Test ceta and laboratory analyses that form the bases for license approval should not come solely from the licensee; confirming data from an independent laboratory should be considered.
BASIS:
When the NRC issued the license to 3M to manufacture the devices and subsequently renewed the license, the NRC had no independent verification of
4 claims made by the licensee concerning the integrity of the components (e.g.,
microspheres) and the behavior of the materials in various environments.
4.3 The existing system of generally licensed devices should be critically examined to assure that the desired margin of safety is inherent, and then verify compliance by inspection of the device distributor and inspection of a representative sample of general licensee users.
BASIS:
Inspection of general licensee users must necessarily be limited by the scarcity of resources and the extremely large number of general licensees and l
generally licensed devices.
The agency should not expect that safety can be i
inspected into the program.
However, a certain amount of inspection should be conducted to ensure that licensees carry out commitments to implement necessary programs.
Although 3M indicated that use environments would be evaluated before its devices were leaeed to a prospective customer, and the customer was warned d
concerning use of the devices in unsuitable environments, many failures were attributed to use in environments warned against in 3M instruction sheets.
4.4 The consequences of contamination of products consumed by or applied to persons should be given serious consideration when the license to I
distribute is originally issued and subsequently renewed.
BASIS:
There is a degree of risk associated with the system of generally licensed devices.
The agency should either accept this risk or establish,
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implement and maintain a more restrictive and confined program.
5.0 ADDITIONAL OBSERVATIONS Many things came to light that do not require specific changes in NRC
'l regulations or activities.
However, they are things that should be borne in mind in the future during response activities.
Suggestions and observations of v
this nature are recorded below.
i 5.1 RESPONSE ACTIONS TAKEN BY THE NRC o
On February 18, 1988, the NRC issued two Orders relative to 3M static elimination devices.
One Order suspended immediately the authority of general licensees to use 3M devices containing polonium-210.
The other Order required 3M to notify all its generally licensed customers by first-class mail of the Order suspending use and to instruct the users to return their devices as soon as feasible but within 90 days.
The immediately effective " suspend use" Order did not allow users a grace period to find, obtain, and install replacement devices.
Many private and government-related businesses stated that compliance with the Order would severely impact their operations:
productivity would be diminished, product quality would be impaired, and/or the livelihood of employees would be compromised.
Some persons became alarmed because of the fear of radiation.
A number of general licensee employees requested biological analyses; others wrote letters to the NRC desiring information on the l
associated health hazards.
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4 Considerable costs were incurred by all parties involved, both before and after the device recall.
Depending on circumstances, various general licensees suffered the cost of radiological consultants, decontamination, lost production, loss of customer confidence, and -- in some cases --
recall of products that had been processed in plants using the 3M devices.
In addition, the 3M Company, the NRC, and many other state and federal agencies expended considerable resources in following up on the suspension of use ef fected by the Orders of February 5,12, and 18.
The diversion of resources by NRC and state personnel for this response activity potentially affected other mission activities that were important to health and safety.
i The short time within which the Orders were prepared and issued did not allow time for the NRC and state agencies to adjust their priorities and identify lower priority work that could not or would not be accomplished.
NRC may wish to consider ways in which costs can be recovered for response 60 incidents.
Not all general licensees complied with the February 18, 1988, Order.
o One-fifth of the devices were returned within 30 days, but only about i
two-thirds had been returned at the end of the prescribed 90-day period.
When it became obvious that the NRC did not have the resources to carry out enforcement proceedings against the hundreds of general licensees that had not returned their devices, the NRC issued a notice on May 18, 1988.
That notice, in effect, provided for those general licensees that had not complied with the Order to continue to use their devices until the expiration of their lease.
(This extension could conceivably last until mid-February 1989 for users whose lease had been renewed just before the Order to general licensees was issued.)
Survey techniques and equipment varied among states, NRC Regions, and o
licensee contractors.
As a result, the data could not be readily compared and evaluated as it was received from different sources.
Most state and Federal radiation control programs do not routinely stock o
enough alpha monitoring equipment (quantity and types) to sustain a major, long-term monitoring capability.
The 3M Company indicated that it was having to respond to too many o
regulatory voices:
the NRC (Region III and Headquarters), FDA, and Agreement States.
A single, full-time clerk was appointed to receive information from all o
sources, record the information, and provide for its distribution.
The reported information was disseminated in daily updates until after the recall of all 3M devices and weekly thereafter through the month of July, i
l when little further activity was taking place.
The updates were sent to l
all Regional offices, all other affected NRC offices, the Commissioners' assistants, and the FDA.
Although the recorder was not always kept fully informed, these reports generally provided complete inf ormation as quickly as it was developed.
Nevertheless, some NRC staff members at the working
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i level felt that they received only piecemeal information and were not fully informed.
5.2 LICENSING AND INSPECTION OF GENERAL LICENSEES 3M had changed the composition of the materials used in manufacturing its o
static elimination devices, but no change was made in the device registry, I
and the NRC was not informed of the change.
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The NRC did not have current specific data on the extent to which the 3M devices were in use throughout the United States and in many foreign countries.
o 3M's manufacturing and distribution licenses were renewed (1) without i
consideration of analytical techniques (e.g., scanning electron microscopy 1
as used by Brookhaven National Laboratory to investigate the integrity of l
microspheres) that became available after the license was originally issued, (2) without adequate consideration given to several literature i
reports of problems with 3M's devices, and (3) with only limited i
information on the number of device failures that were occurring, j
NRC license approval for 3M's devices was predicated largely on health o
physics considerations, but device failure was primarily a design and chemical problem that led to a health physics problem (i.e., environment unsuited to the epoxy in use).
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The NRC's Document Control-System (DCS) was not used during the staff's
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response because the DCS did not contain the pertinent information.
. Licensing documents were not available to Headquarters staff until they 3
were telefaxed from Region III, and the telefax copies were not always readily legible.
(All licensing documents are now being entered.into the j
DCS, so the system will be up-to-date within a few years.)
The NRC has no licensing requirement or independent determination of i
o competency and ability for decontamination service contractors.
Anyone acting in that capacity could therefore be involved in handling radioactive material under a customer's license, possibly without appropriate experience, qualification, or training.
Some Agreement States require that radiological service contractors be specifically licensed to handle radioactive material.
These contractors are responsible for establishing and implementing necessary management and radiological controls.
In non-Agreement States, radiological service contractors work under the auspices of the NRC license of the client being serviced.
If the license is a specific license, the licensee usually has the technical competence and ability to assure that proper management and radiological controls are established and implemented.
In these cases, the licensee is held responsible and liable for the radiological safety and actions of the contractor.
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i However, in the case of a radiological service contractor doing work for a i
general licensee, the general licensee likely does not have the technical competence and ability to be responsible and liable for the radiological safety and actions of the contractor.
In some cases it was apparent that the contractor engaged by the general licensee was not competent or lacked I
the necessary resources to establish radiological controls and effect decontamination.
Several times regional inspectors found that the decontamination effort performed by the contractor was incomplete or not effective.
In other cases, it was apparent that the contractor did not understand the nature of the problem and how to monitor the contamination.
Although the radiological concern in this particular case was relatively benign, it is probable that some organizations that perform radiological services may not have sufficient competence, training, and qualification for the services rendered.
Unqualified service companies or individuals pose a potential for creating problems and putting personnel at risk.
Evaluation of the pplication to manufacture and distribute devices for use o
under general license called for specialized expertise in disciplines other than health physics, access to an extensive literature collection, and knowledge of related actions in other countries (e.g., Canada's experience with 3M devices).
Many Agreement States need additional training and experience to review applications of this type.
For the reasons given above, some persons believe that licensing of o
generally licensed devices could be a candidate for centralization.
In addition, decentralization resulted in the licensee having to respond to several regulatory voices, both federal and state.
- 5. 3 COORDINATION WITH OTHER AGENCIES Not all agencies were agreed on acceptable levels of contamination.
o The value of 5 nanocuries (~11,100 dpm alpha) was considered by some Agreement States to be too high for hand-held static elimination devices (Models 902 and 906).
For these models, surface contamination could have been transferred to workers' hands and clothing, spread about the work area, and could conceivably have been ingested.
At least one Agreement State required decontamination to less than 20 dpm/100 cm2 5.4 CHANGES OR ADDITIONS TO REGULATIONS Several questions arose concerning the General License program:
(1) o Should 10 CFR 31.3 and 31.5 be deleted in their entirety?
(2) Should a limit be placed on the quantity of material that can be generally licensed?
(3)
Should the quantity of material that is exempt from licensing be increased so that a general license would not be needed for such devices?
General licensees have little comprehension of the nature of their o
radioactive devices and the restrictions on their use.
Many employees of the general licensee are unaware that the facility even has radioactive
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material in its possession.
The Agreement St6te of Texas reported that 50 I
of the 3M devices were lost by its general licensees in a four year period.
l The copies of NRC regulations supplied by 3M to its' customers were in very small type and legible only with difficulty.
This fact may.have downplayed the significance of these regulations in the minds of the recipients.
The 1
3M customer contact is ordinarily a purchasing agent who has nothing to do with the installation or use of the devices.
The shipping clerk who i
receives the package may not provide enclosed papers to persons in the work area.
Many general licensees either had not received the notification from 3M l
that their devices had been recalled or had not given attention to the l
notification when it was received.
(Food, beverage, drug, and cosmetic industries were an exception to this generalization; some had already taken i
action when contacted by the state.) When notified by personnel from the state agency, most general licensees responded promptly to the Order.
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