ML20196E684
| ML20196E684 | |
| Person / Time | |
|---|---|
| Issue date: | 02/18/1988 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 8803010242 | |
| Download: ML20196E684 (54) | |
Text
_ _ _
ORlGNAL
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION 1
Title:
Briefing on Static Elimination Problems Location:
washington, o, c.
Date:
Thursday, February 18, 1988 i
Pages:
1-36 Ann Riley & Associates 4
Court Reporters 1625 l Street, N.W., Su!te 921 Washington, D.C. 20006 1
(202) 293-3950 l
8803010242 880210 pf 9, f PDR i
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1 D I SCLA I MER 2
3 4
5
~6 This is an unoffic'lal transcript of a meeting of the 7
United States Nuclear Regulatory Commission held on S
2/18/88 In the Commission's_ office at 1717 H Street, 9
'N.W.,
Washington, D.C.
The meeting was open to public s
10 attendance and observation.
This transcript has not been 11 reviewed, corrected, or edited, and it may contain
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12 inaccuracles.
'-g 13 The transcript is intended solely for general i
14 informational purposes.
As provided by 10 CFR 9.103, it is 15 not part of the formal or informal record of decision of the 16 matters discussed.
Expressions of opinion in this transcript l
17 do not necessarily reflect final determination or beliefs.
No 18 pleading or other paper may be filed with the C atsm i s s i c.n in 19 any proceeding as the result of or addressed to any statement 20 or argument contained herein, except as the Commission may 21 authorl=e, 22 23, 24 25 w
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1 UNITED STATES OF AMERICA 2
NUCLEAR REGULATORY COMMISSION 3
4 BRIEFING ON STATIC ELIMINATION PROBLEMS 5
6 PUBLIC MEETING 7
8 Nuclear Regulatory Commission 9
Room 1130 10 1717 H Street, Northwest 11 Washington, D.C..
12 13 Thursday, Feburary 18, 1988 14 15 The commission met in open session, pursuant to 16 notice, at 2:10 p.m., the Honorable LANDO W.
ZECH, Chairman of 17 the Commission, presiding.
18 COMMISSIONERS PRESENT:
19 LANDO W.
- ZECH, Chairman of the Commission 20 THOMAS M. ROBERTS, Member of the Commission 21 FREDERICK M.
BERNTHAL, Member of the Commission 22 (By telephone hook-up) 23 KENNETH CARR, Member of the Commission
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24 25 4
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STAFF AND PRESENTERS SEATED'AT THE COMMISSION TABLE:
2 J. HOYLE, Secretary 3
W.
PARLER, OGC 4
V. STELLO, EDO 5
DR. FRANK YOUNG, FDA 6
R.
BERNERO 7
I 8
9 10 11 12 13 14 15 i
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19 i
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21 22 23 i,
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3 1
PROCEEDING'S g--
2 CHAIRMAN ZECH:
Good afternoon, ladies and gentlemen.
3 Commissioner Rogers is on travel and will not be with us this 4
afternoon.
Commissioner Bernthal is ill at home, but I 5
understand he is on a conference call.
Can you hear us, 6
Commissioner Bernthal?
7 COMMISSIONER BERNTHAL:
Yes, but it seems to be
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8 coming in and out.
9 CHAIRMAN ZECH:
All right.
10 COMMISSIONER ROBERTS:
I don't know how sick you are, 11 Fred, but I admire your devotion to duty.
12 (Laughter.)
13 CHAIRMAN ZECH:
All right.
And I understand also the five Regions are on, and I presume they have been checked 14 15 out.
Is that right, Mr. Secretary?
16 MR. HOYLE:
Yes, sir, they have been checked out.
17 CHAIRMAN ZECH:
All right.
This afternoon's briefing 4
18 is a status briefing before the Commission.
The NRC staff will i
19.
address the current actions being taken to address the failure 20 of 3M static eliminator devices.
On January 21st, 1988, 21 Ashland Chemical company reported an accident involving 22 radioactive contamination which was traced to a static 23 eliminator device.
This device uses high velocity air passing
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24 near a polonium 210 radioactive source to ionize the air.
The 25 air is used to removo dust from containers.
4
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1 The device is manufactured under NRC license by 2
Minnesota Mining and Manufacturing Company.
Subsequent to the 1
3 Ashland Chemical report, the NRC has issued three immediately 4
effective ~ orders to Minnesota Mining and Manufacturing Company, 5
one suspending distribution of these devices, and two, i
6 ir.volving removal of these devices from use in processes that 7
have the potential for the contamination to be consumed by or 8
applied to humans.
9 Specifically, food, beverage, cosmetics, and 10 pharmaceutical applications have been suspended, and the 11 devices recalled.by the manufacturer in accord with NRC orders.
12 Two additional immediately effective orders have been prepared 13 for issuance today.
They direct the 3M Company first to 14 suspend the use o'f all polonium 210 devices within 30 days.
15' Second, recall all polonium 210 static eliminator devices to 3M 16 within 90 days.
17 Third, to promptly test the devices for detectable I
18 radioactive leakage, and if any is detected, notify the users 19 of the device of the potential.for contamination in the 20 workplace.
And fourth, to notify the NRC or the agreement 21 state of the leaking device.
22 A report of compliance with the order and any I
23 exceptions is also required by the orders.
In cases where 24 safety considerations exist that requiro the continued use of 25 the devices, the order to the users contains a provision to
5 1
allow continued use with suitable monitoring under written 2
approval from the NRC or the agreement state for the specific 3
case.
These orders are to be published in the Federal Register 4
in approximately five working days.
5 The NRC has been and continues to work closely with 6
the Food and Drug Administration and with the agreement states 7
to assure that all available actions are being taken to protect 8
the public and workers.
Dr. Frank Young, Administrator of the 9
Food and Drug Administration, is here with us today, as he was 10 last week, when the Commission was briefed on these facilities.
11 We welcome you, Dr. Young, and we appreciate your 12 being with us today.
13 DR. YOUNG:
Thank you.
14 CHAIRMAN ZECH:
I urge the staff and the FDA to 15 continue to work together to assure that we are doing all that 16 we can to protect health and safety.
17 Do my fellow Commissioners have any opening remarks 18 to make?
19
[No response.)
20 CHAIRMAN ZECH:
If not, Mr. Stello, you may proceed.
21 MR. STELLO:
Thank you, Mr. Chairman.
As you have 22 already indicated, we are pleased to have Dr. Young with us I
23 again today, and I have Mr. Bernero with me, who has been 24 following this essentially full-time, seven days a week, to 25 understand the full significance of the issue that we are faced
6 1
with.
2 You have already indicated that you had approved an 3
order and you described the context of that order, and it has 4
in fact been signed, and a copy had been sent to 3M, and the 5
remaining order -- orders will be placed in the Federal 6
Register, as you indicated, in about five days.
7 We expect that this will be a problem that will be 8
with us, as we indicated last time, for some time.
The number 9
of devices is large.
The number of facilities where we have 10 found contamination continues to grow.
Our purpose today is to 11 brief you on where we stand with respect to our knowledge of 12 the problem, what we have done about it, and what more remains.
13 With that, I will turn to Mr. Bernero to give you a 14 brief status, and that will be followed by some remarks by Dr.
15 Young.
16 CHAIRMAN ZECH:
All right.
Thank you very much.
Mr.
17 Bernero, you may begin.
18 MR. BERNERO:
Thank you, Mr. Chairman.
19 May I have the first slide, please?
20 (SLIDE.)
21 MR. BERNERO:
I have a slide here just to refresh 22 your memories on the licensing basis or the requirements for a 23 generally licensed device such as we are talking about here.
24 The regulations, and these are rather old regulations -- they i
25 go back many years.
A device for general licensir.g has four
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7
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1 ke provisions.
It should be safely handled by persons,who are g,
2 not specifically trained in radiological safety, and under 3
ordinary conditions, nothing should be released.
The 4
radioactive material should be closely or tightly held.
5 In addition, there are two other requirements that 6
relate to the direct radiation in normal use and the release or 7
dosage in case of fire.
They aren't really pertinent here and 8
I don't intend to dwell on them.
The 3M' license, which is a 9
specific license authorizing general license distribution is 10 also an old proceeding.
It goes back to 1965.
And I must say 11 that in the record of the licensing as best we can understand i
12 it -- obviously, going back so many years you have different 13 people who are no longer with us -- I think it was clear that 14 there was an understood potential for some leakage, no barrier 15 could be perfect if you have an adhesive of these microspheres, 16 but it was not expected to have releases under ordinary 17 conditions.
That is the best we can interpret the entire 18 record, although I just say there is no explicit numerical 19 criterion on what constitutes acceptable leakage, there is no 20 thousandth of a percent or one in a million or any number like 21 that.
22 The license in question or licenses were expanded to 23 multiple devices with increased reporting requirements in 1978, 24 about a decade after they were first issued.
I include a 25 picture of the microsphere just to refresh your memories.
8 i
1 Remember,.this is the key safety system where the radioactive 2
material is tightly held in this particle so that even if it is 3
released the public risk is not great, because the microsphere f
4 is a rather_ robust form, it is a little too large to be 5
breathed, and it is also quite insoluble, and there are 6
solubility data in the licensing record to support that.
i 7
May I have the next slide, please?
8 (SLIDE.)
9 MR. BERNERO:
You reviewed some of the chronology.
I 10 have two slides here, Number 1 and Number 2, of chronology, and 11 all I would like to say is, rather than go into the specifics 12 of the order which you already summarized, I would like to 13 characterize the thrust of the investigation.
At the very 14 beginning it appeared, since this was a chemical works and an 15 isolated report, it appeared that we were dealing with an
.t 16 exceptional case, and if you read the order, if you read the 17 record, if you were involved at all in the discussions at the I
18 time, there was an appearance of focusing on an exceptional 19 case and as the data grew and this first chronology sheet shows 2'O more failure data coming in in the weeks following the initial 21 report and the initial investigation, it led us to the concern 22 toward more widespread application, but still focused on the 23 compressed air devices.
24 The even numbered, 902, 902F, 906, and 908, are the j
25 serial numbers of the static elimination devices.used with i
4
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1 compressed air, the highest velocity.
2 Still, the focus was on exceptional cases or 3
exceptional circumstances with an alarming increase in the 4
numbet The food, beverag's, cosmetic, and pharmaceutical uses, 5
packaging, that we encountered, and we are finding failures 6
there, that raised a concern with our sister agency, the FDA, 7
and of course a great deal of priority given to pursue those 8
' applications, one, to find and stop the leakers, and secondly, 9
to examine the products wherever they were actually or 10 potentially contaminated.
11 May I have the next slide, please?
12 (SLIDE. )
13 MR. BERNERO:
If you go to the second chronology, 3M, 14 in accordance with the first order, submitted to us a letter 15 report containing a plan on February 8th, and there was a 16 subsequent meeting on that plan on February lith.
17 The February 8th report had a body of data that was i
18 available to 3M apparently at that time, and their focus was on 19 environmental causes, the situations in which the devices were 20 being used.
I will show you one of their data sheets in a 21 moment.
22 Their plan, which I have also reproduced for your I
23 reference in a subsequent slide, was a minimal one focusing on 24 the possible misapplication of some devices.
In other words, 25 they have a position called static analyst, a person who looks i
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1 i
10 1
at the application in the field to see that it is suitable for 7
2 the device and there could have been misapplied devices, again 1
J 3
the focus on exceptional circumstances.
4 The meeting on the lith, we discussed those 5
materials.
The 3M top management was present.
They did not 6
have any more data to offer but they requested access to the 7
data we had.
By that time, the resources and field work being 8
done by the NRC, by the agreement states and by the FDA, was 9
producing a preponderance of data that was not immediately and 10 directly available to 3M, because we were out getting it or the 11 states were out getting it.
12 We agreed to have technical staff of the states, NRC 13 and 3M pool this data, and that meeting is taking place 14 tomorrow, and in discussing the plan of action, 3M agreed to 15 submit a more detailed plan by February 26th, which is two 4
16 weeks after the meeting.
17 Now, as we continued all last week, we got more and 18 more data.
Remember, the first order suspended the 19 distribution of the compressed air devices in food, beverage, 20 cosmetics and pharmaceutical, but did not withdraw the existing i
21 ones.
What we did in order number three on February 12th, and 22 I must say at the February lith meeting, 3M said it was their l
i 23 intention to do this, we withdrew all models of all the devices i
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24 from production and packaging of food, beverage, cosmetics and 25 pharmaceutical products.
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2 directly from the 3M February 8th report, if you look at the
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upper cross line, bottling industry, they were analyzing by l
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4 industry application, and you see a distribution of failure in 1
5 bottling that seems to be significantly higher than the j
6 occasions of failure in other applications.
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7 Also, if one looks at the food industry, over on the
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8 righthand side, you see 30 with a footnote "4" and 3 with a 1
9 footnote "5," the data there was puzzling because there were 10 situations where contamination was not found on the nozzle, but 11 was found in the plant, and so there appeared to be some sort 12 of failure patterns there.
13 Again, the focus here was on adverse environment that 14 would be exceptional, not typical.
i 15 The plan that I mentioned earlier is this next slide.
4 1
i 16 This is lifted verbatim from the report of February 8th by 3M.
)
17 (SLIDE.]
i 18 MR. BERNERO:
You can see by perusal of it that it is 19 fundamentally reviewing the list of distribution, improving 20 product literature, improving static analysts' training in order to weed out exceptional causes of failure.
21 2.
(SLIDE.]
4 23 MR. BERNERO:
In the meanwhile, the NRC staff sent an l[,
24 inspection team up to 3M and gathered the data from their own i'
25 records.
What I have here is a table which was used in our 1
i l
12 1
February lith meeting.
I have added a few notes to it for your 2
information.
3 Basically, for the distribution set that was 4
distributed in 1986, from the 1986 reports.
If you look at the i
5 prices, they are broken down by model number into the brackets a
6 of compressed air use, static bars and blown air.
The numbers 7
are representative.
1987 would have been somewhat different 8
and 1988 even different still.
The basic distribution of 9
devices is rather significant, I think.
10 Fifty-seven percent of all the devices are compressed 11 air; 34 percent are static bars and only 8 percent are blown 12 air.
13 From the 3M records, the next column, we found 14 detectable leakage at the plant, at~the 3M plant of these 15 devices as listed, but as reported, the two columns on the 16 righthand side, were data that was analyzed and then filtered t
17 in a way by saying, well, there was a damaging environment, so 18 that accounts for the release and therefore it is not a leaking 19 device, it is a damaged device.
3M made that distinction.
i 20 In addition, 3M had a procedure for sampling in the 21 plant we found inadequate.
They have since corrected it, after 22 this inspection.
As a result, one must look at the raw data in 23 the more or less center column, the number leaking "all," that 24 column, as equal to or greater than data, that if a proper 25 procedure had been used, not only would the ones. listed have l
1 l
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shown up as leakers but probably more.
It had to do with a 2
screening swipe that had sort of a decontaminating effect.
3 CHAIRMAN ZECH:
Were we aware of this definition they 4
were using, this criteria they were using for leaking devices 5
as far as calling some damaged and some undamaged?
6 MR. BERNERO:
Not until we did this inspection and 7
analyzed the data that you see.
They were informed of that at 8
the time.
9 The thing to see here is when we go back to this i
10 data, which may be an under call, we see the distribution i
11 involving other model numbers and the rather interesting thing, 12 for most of them, it is about a tenth of a percent failure rate 13 that is reported.
14 With that, we used this list, recognizing the frailty 15 of the data, we used this list as a source --
4 t
l 16 CHAIRMAN ZECH:
Where do you see a tenth of a 17 percent?
18 MR. BERNERO:
The numbers in brackets,.04 percent, j
19
.7 percent and so on, those numbers represent a failure rate 20 obtained by comparing 5 to 13,138 or 62 to 8,700.
I 21 CHAIRMAN ZECH:
It looks to me like
.9.
22 MR. BERNERO:
Yes, it is between half a percent and a 23 tenth of a percent.
I just rounded it off.
)
CHAIRMAN ZECF,:
If it is
.9, it is about one percent.
24 i
25 MR. BERNERO:
Yes, it could be as high as one
l 14 1
percent.
It is as low as.04 percent.
Most[ofthemareinthe s
2 cluster of a half to one.
3 CHAIRMAN ZECH:
Do we consider one high?
That seems 4
to me to be something we should be concerned with.
5 MR. BERNERO:
The concerns that one gets looking at 6
these data, the concerns are that in the first place, it is I
l l
7 getting close to the failure level certainly that one would l
8 say, hey, that's too much, that can't represent ordinary 9
conditions.
It is distributed over other model numbers.
It is 10 not merely in the compressed air devices.
11 CHAIRMAN ZECH:
Were we aware of these percentages, 12 almost one percent?
When were we first aware of that?
13 MR. BERNERO:
I would say we found this out in the i
14 last two weeks, about a week and a half ago.
15 CHAIRMAN ZECH:
Is there anything in our regulations i
16 that require a certain number as far as a leakage percentage or
)
l 17 do we require any reports from them if it looks to them like
' i 18 the leakage is higher than it should be?
19 MR. BERNERO:
We require reports at.005 microcuries 20 detected activity released.
That derives from the regulations.
21 That is not the detectable level.
There is no criterion either in the license or in the regulations that says what percentage 22 23 of leaking devices constitutes unacceptability or 24 acceptability.
i 25 CHAIRMAN ZECH:
Maybe there should be, i
i 4
0
15 j
1 MR. BERNERO:
The regulations, in that first slide, 2
the regulations just say in ordinary use, the material should 3
not be released.
4 CHAIRMAN ZECH:
Maybe there should he.
I assume you 5
will look at this.
6 MR. BERNERO:
It is something we will definitely look 7
at.
4 8
The other thing that I would point out as a cause for 9
concern looking at this data is if the models are so different, l
10 than we ha e a lot broader problem than the focus we had at the 11 beginning of focusing on the compressed air models and the 12-exceptional case.
l 13 (SLIDE.)
l 14 MF. BERNERO:
The next two sheets are a list that we P
15 have tried to keep available to you as we went along.
It is a 16 list of sites with failed devices.
If you look at the footnote I
17 on the lower right, contamination at these facilities exceeded i
j 18
.005 microcuries.
That is 11,000 disintegrations per minute.
.I 19 That's the reportability criterion in the regulations.
We use 20 it as a threshold to sort this list, although we knew there 21 were other facilities where less than that level of 22 contamination was detected, was found, but it was below the 23 reported level.
24 This is an incosplete list.
It changes daily.
It 25 does show, however, many diverse applications and different i
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.g, models of the devices are involved, and what is more troubling
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is it shows many different, very dif.*erent pathways for 3
exposure to persons.
If you'go to the second page, you.will 4
see number 37, the Moto Photo Shop in North Dartmouth, i
I 5
That occurred last Saturday.
It was discovered 6
last Saturday.
This is.one of.these photo developing shops you 7
find in a shopping mall.
8 Our inspectors found quite a 6it of contamination 9
leaking from the device used to cut the static on the film that 10 was being developed.
It was a compressed air model.
How much 11 of it tracked out into the mall or what is just unknown.
You i
12 can see the many different pathways to man that can be seen.
13 Of course, many of these are food, beverage, cosmetic and 14 pharmaceutical applications.
i 15 CHAIRMAN ZECH:
Do your orders require all these 16 devices be recalled?
17 MR. BERNERO:
Yes, they do.
I am going to give you a 18 summary of the orders.
19 CHAIRMAN ZECH:
The ones on this sheet, the devices 20 are all being recalled?
21 MR. BERNERO:
Yes.
They are either recalled 22 immediately, if they are food, beverage, cosmetic and 23 pharmaceutical, they are already recalled and that is in 24 motian, or they are recalled by today's orders on a timeframe 25 if they are other appl'ications, with on1y a safety exclusion
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that I will explain.
7-2 One other thing.
I haven't even had time to type 3
this up in a usable form.
We have.had telephone call-ins from 4
the agreement states and in a rough summation of all the 5
agreement states, they have surveyed by now 828 facilities and 6
found detectable contamination, not reportable but detectable 7
contamination at 118 facilities of the 828.
That is 8
approximately 15 percent.
That of course, would clearly be an 9
unacceptable level of rele.ase.
lo (SLIDE.]
11 MR. BERNERO:
You may recall from a week ago when you 12 were briefed on this, the current safety conclusion was the j
13 very thing, and I consciously used the very. conclusion, because 14 we are still holding to this conclusion.
Based on the data we 15 have at this time, even if these microspheres gained access to 16 the workplace or to the consumer products, it f.s unlikely there 17, is a significant health hazard to the public.
That does not 18 excuse us of vigorous evaluation of the potential safety 19 significance and getting out there to find what is contaminated 20 and to stop it.
21 In order to do that, we felt, considering the broad 22 range of models and applications involved and the growing 23 failure rates, the more we looked at it, the higher the failure 24 rate appeared to be, we generated the two orders of February 25 18th that were signed rrd started out this morning, and the
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18
. 1 I
1 summary is there-are two orders because of tha parties
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2 involved.
3 We have one order as to 3M and the other crder is to 4
the general licensees using the 3M static elimination devices.
5 In essence, the orders suspend the transfer and use of these-1 6
devices, recall them to 3M for tests and appropriate use of the i
7 test results, and there is an exception in the ordor for 8
competing safety risks.
9 (SLIDE.]
10 MR. BERNERO:
I would summarize the orders.
The 3M 11 order, and I have tried to paraphrase the five elements of the 12 order --
13 CHAIRMAN ZECH:
You mean the order to 3M?
14 MR. BERNERO:
Yes.
15 CHAIRMAN ZECH:
From NRC?
16 MR. BERNERO:
Yes.
The order to 3M from NRC says, 17 first of all, suspend transfer,of these devices except as 18 specifically authorized by NRC.
Secondly, immediately notify l
19 the general licensees.
This is the priority way'for the 20 general licensee to learn of this.
They will get a copy of the 21 orders through 3M in this order clause.
22 Third, instruct the users to return the devices, you 23 know, the packaging and things like that, identification, as i
24 soon as feasible but no more than 90 days from the date of the I
25 order.
19 1
Fourth, 3M will test the returned devices for 2
leakages, one of-the important pieces of data, which may indicate contamination out 'here in the field that needs to be 3
c 4
found, and therefore, the results of the tests where leakage is 5
found, detectable leakage, notify the user who sent the device 6
in, the NRC and the affected agreement state.
7 Lastly, provide status reports on the progress in 8
doing this at 30 day intervals.
9 In addition, this order, and I separated it here, is 10 a show cause order.
It is an instruction to 3M to show cause 11 in 60 days why this license shouldn't simply be revoked, and i
12 then just proceed with the clean-up.
13 The corollary order to the general licensees, and 14 this is under our regulations, to them, we order suspend the i
15 use of the devices.
Secondly, send the devices back to 3M 16 within the 90 days, and thirdly, we do leave a loophole, if you 17 will, temporary continuation of use is possible where it is 18 essential for safety.
This is fire, explosion or other 19 hazards, in order to suppress it.
It would require written 20 approval of the NRC or the agreement state involved and it 21 would be under surveillance to be specified by them.
That 22 would be unique to the application.
That exception does not 23 apply to food, beverage, cosmetic, pharmaceutical or medical 24 devices.
It applies only to what we would call industrial or 25 commercial applications.
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20 1
COMMISSIONER ROBERTS:
Whc makes the call on the g_,
2 first element of essential.for safety?
3 MR. BERNERO:
The user says, I need it, and has to 4
ask for permission.
The order is written to have the affected 5
regional administrator or the affected agreement state 6
authority make the call of whether it is acceptable and the 7
conditions under which it would be acceptable.
8 Note, it is temporary and it would give an 9
opportunity for alternative courses to be sought, and of i
10 course, the time period can be controlled that way.
11 Keep in mind, the half life of these devices, the 12 half life of the isotope, is relatively short, so that the i
13 isotope drops in radioactivity level by approximately a factor 14 of six in one year.
15 CHAIRMAN ZECH:
A half life is what?
16 MR. BERNERO:
138 days.
It really decays rather 17 substantially in a year.
18 This order is also published in the Federal Register.
i 19 That is the formal way to promulgate it, but the expeditious 20 distribution of it is through the order to 3M.
21 CHAIRMAN ZECH:
Which we have done?
22 MR. BERNERO:
Yes, that's the fastest way to get it 23 to all.
t 24 That's the summary.
I would like to turn it over 25 now.
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21 1
' MR. STELLO:
Mr. Chairman, with your permission, I 2
will turn to Dr. Young for one comment, but I don't know that 3
the presentation was clear and I would like to make sure it is.
4 This order is immediately effective.
These devices 5
are cease and desist now.
The timing of the issues are more 6
with respect to the timing to be returned to 3M.
7 CHAIRMAN ZECH:
I was going to.ask about the 30 and 8
90 days.
It is immediately effective?
1 9
MR. BERNERO:
Yes, to summarize,.the food, beverage, 10 cosmetic and pharmaceutical devices are already under order for
'll return by, I believe, it is March 2nd.
That is in progress.
12 That is going on right now.
13 This order recognizes that.
It is explicitly 14 recognized.
Then what we are dealing with are the rest,of the 15 devices, what I call commercial and industrial.
Those have as 16 soon as feasible but not longer than 90 days.
17 CHAIRMAN ZECH:
To do what?
18 MR. BERNERO:
To return them.
It says cease 19 immediately.
Of course, that is going to be a variable time 20 depending on when the individual licensee got the word and so 21 forth.
22 (Commissionar Roberts left the room at 2:40 p.m.]
23 CHAIRMAN ZECH:
We have given orders now to cease and desist their use.
24 25 MR. BERNERO:
Yes.
t
22 1
MR. STELLO:
Effective immediately'.
- c 2
CHAIRMAN ZECH:
Of not only the food and drug type, 3
pharmaceutical, cosmetic devices, but all the others also?
4 MR. BERNERO:
All models, all applications.
5 CHAIRMAN ZECH:
All models, all applications of these 6
devices.
The order calls for them to cease with their use 7
immediately and to recall them; is that correct?
8 MR. STELLO:
That is correct.
9 DR. YOUNG:
First of all, Mr. Chairman, I want to 10 thank your staff for the very thorough interaction with our 11 staff and the cooperation that you have given us in the ability 12 to fulfill our mission.
13 CHAIRMAN ZECH:
I appreciate that.
14 DR. YOUNG:
They have done a tremendous job, and I 15 know they have been working around the clock oin it.
16 CHAIRMAN ZECH:
I know they have been working very 17 hard, and I appreciate what you and your people have been 18 doing, too, Doctor.
This is our joint responsibility.
19 DR. YOUN.G:
Yes, it is.
20 CHAIRMAN ZECH:
And we want to make sure that you get 21 the continued cooperation of our staff.
If you don't, please 22 let me know.
23 DR. YOUNG:
They have been very cooperative.
And I 24 also fully support your action t' hat is taken to remove these 25 from the marketplace.
I think that's particularly relevant,
23 1
because I do have a letter that I know the 3M. company sent out g
2 as of February 15th,
'88, that said if firms believed that the 1
3 device was imperative for continued use, to contact FDA for 4
approval for that continued use, and I want to state for the 5
record that we fully support your action that no approval of 6
such continuatinn should be provided.
j u
7 We have done the following things since our last 8
meeting:
9 First of all, we have inspected each of the 16 firms 10 that have now been identified, 13 plus the original ones that 11 were on, and have collected samples from 13 of these and 12
. completed most of the analyses.
13 Altogether, we have analyzed over 1300 samples, and 14 we will continue to have our Winchester Laboratory working a 15 two 12-hour shift to deal with this.
l 16 We have also divided our products into.those that 17 might present a risk and have looked at those first, and then 18 followed up on others that we would think would be less risky, 19 For example, we were looking first at devices that 20 were in things such as nasal sprays or anything that would go 21 directly into the body, in contrast to lotions or creams, where 22 we know that the penetration of the skin would be low.
23 We have looked, as your lists have provided, and 24 found about 263 firms that do fall within the Food, Drug and 2F Cosmetic Act that are either producing drugs, biologics, s
24
-1 devices, cosmetics or foods.
.Q 2
Of these, we have found in your plants that had 3
detectable radiation above the limit no samples that were 4
positive.
5 We have found one fragment of a microsphere in one of 6
the plants that you had detectable activity, but not above the 7
background, and this was very helpful again to have your total 8
list of those that have any detectable activity.
9 We are going to take the strategy of looking at all 10 of these firms first with those that were detectable and out of 11 compliance.
We have found no evidence of contaminated product 12 there.
Detectable but not out of compliance, as you define it, 13 and then all other plants.
And we will look in that fashion.
14 We continue to believe, as you have pointed out, from 15 our analyses that there is no evidence of any public health 16 hazard at this time and no hazard to health.
Even in the event 17 that an entire microsphere were ingested or an entire 18 microsphere were inhaled, we do not believe, based on the 19 calculations and the calculations that we have received from 20 your agency,' lead us to feel very strongly that there would not 21 be a health hazard.
And I think the important thing for the 22 American people to realize is that although we are out and 23 going to inspect all of the plants, and though we will examine 24 the samples, we are doing this to provide an extra layer of 25 safety so that we can be sure that there is not that rare gun
25 1
out there that may be leaking more than we would anticipate.
2 We are very comfortable at this time, based on the 3
evidence that we have, that there is neither a hazard to public 4
health or a hazard to individual health.
5 CHAIRMAN ZECH:
Thank you very much, Doctor.
Does 6
that complete --
7 MR. STELLO:
That completes cur presentation, Mr.
8 Chairman.
9 CHAIRMAN ZECH:
All right.
I will ask for comments 10 from my fellow Commissioners.
Commissioner Roberts had to 11 leave for a few moments for a previous appointment.
12 Commissioner Carr, do you have any questions?
13 COMMISSIONER CARR:
No.
14 CHAIRMAN ZECH:
Commissioner Bernthal, I know you are 15 on.
I hope you have been able to hear us all right.
Do you 16 have any questions?
17 COMMISSIONER BERNTHAL:
No, I don't.
I think I got 18 about 75 percent of it.
19 CHAIRMAN ZECH:
All right.
20 Well, let me ask a couple.-
21 First of all, what is the total number of devices 22 that we have that we are talking about?
Do we know, the total 23 number of devices?
24 MR. BERNERO:
Well, if you use the chart that I had 25 to show the distribution of models, in 1986, it was
26 g-(
1 approximately 42,000 devices, and the current number is 2
probably not too far from that.
I don't know the exact number, 3
but that's a reasonable figure for the total.
And the 4
breakdown of them is on that chart that I used where they are 5
broken down into compressed air, static bars and blown air.
6 CRAIRMAN ZECH:
Now, that's the total number, 42,000?
7 MR. BERNERO:
42,000 devices, units, and they are all 8
9 CHAIRMAN ZECH:
Of all kinds?
10 MR. BERNERO:
All kinds; all forms, all model 11 numbers.
12 CHAIRMAN ZECH:
All right.
I have been told that 13 there is another manufacturer of similar devices, and that a 14 site visit was scheduled for last week, I think that's correct.
15 What was the result of that visit?
And is the Staff sure that 16 we don't have a similar situation with that licensee?
17 MR. BERNERO:
Okay, that staff visit was made.
It's 18 actually a New York State licensee.
The New York State 19 licensee.uses a somewhat different technology.
20 CHAIRMAN ZECH:
Is it a different manufacturer than 21 3M?
22 MR. BERNERO:
Yes, it's a different company, 23 different manufacturer, and a different way of doing it.
24 CHAIRMAN ZECH:
How many devices have they got?
25 MR. BERNERO:
If I remember the number, it's
27 s
1
' a p p r o x i m.a t e l y, 1 5 0 0, a little bit over - ~
2 CHAIRMAN ZECH:
Is that included in the 42,000?
3 MR. BERNERO:
No, no. This is --
4 CHAIRMAN ZECH:
These are in addition?
5 MR. BERNERO:
These are polonium-210, but they have 6
gold foil, it's not a microsphere --
7 CHAIRMAN ZECH:
Are we examining those?
8 MR. BERNERO:
They have been looked at, and the State 9
of New York -- apparently they are distributed only in New 10 York, and that is an agreement state.
But our staff has been 11 out there, has looked at the devices.
There is no evidence of 12 failure in those devices.
13 There is another supplier that is an NRC licensee in 14 California that we are tracking down now that is licensed to 15 make static eliminators using polonium-210 of a much, much 16 smaller size, at least an order of magnitude smaller in size.
17 They are things like static brushes for --
18 CHAIRMAN ZECH:
But we are contacting that 19 manufacturer?
l 20 MR. BERNERO:
Yes, we are contacting them to see what I
21 22 CHAIRMAN ZECH:
Have we contacted them yet?
I I
23 MR. BERNERO:
I can't say that for sure.
We're 1
24.
working through Region V.
s 25 CHAIRMAN ZECH:
Region V, are you on the phone?
Do i
4
28 1
you know?
2 MR. BERNERO:
An important feature there is it's a 3
significantly smaller device to begin with.
The inventory of 4
radioactive material in it is at least a'n order of magnitude 5
smaller.
6 CHAIRMAN ZECH:
But that is another manufacturer 7
other than the 3M and the New York --
8 MR. BERNERO:
Yes.
9 CHAIRMAN ZECH:
How many more do we have?
l'O MR. BERNERO:
We know of no others.
11 CHAIRMAN ZECH:
I see.
Well, let's find out if 12 they've been contacted.
If not, contact them as soon as 13 possible.
14 MR. BERNERO:
Absolutely.
We are tracking that down.
15 CHAIRMAN ZECH:
And I presume that we are going to do 16 an inspection of that firm also.
17 MR. BERNERO:
Yes, indeed.
I 18 We believe California is inspecting -- see, 19 California is an agreement state, and we believe California is 20 inspecting.
We don't have their report yet, but California is f
21 one of the states participating in this meeting tomorrow.
The 22 five states are participating, in my last news, and they are 23 all major user states -- that is, California, Illinois, Florida 24
-- oh, I forget the other two,.but states with a large 25 in'rentory of these devices.
29 1
REGION V SPEAKER:
You made a comment a moment ago
('N i
c l
2 about the facility out here in California.
l 3
CHAIRMAN ZECH:
Yes, Region V, go ahead.
4 REGION V SPEAKER:
You were making reference to 5
neutron products which is in the local area here.
We had a 6
call yesterday from Steve Baggott to send the complete license 7
file back to him, which is being done today.
The inspection on 8
this -- they have been inspected four times over the last two 9
years, and they have always had a clean inspection.
They have 10 nothing in the way of a bad enforcement history or inspection 11 history on.those people.
{
12 CHAIRMAN ZECH:
All'four inspections, you say, were 13 clean inspections?
That means you detected nothing improper, 14 no problem with our regulations?
l 15 REGION V SPEAKER:
That's right.
They were clear 16 inspections.
17 CHAIRMAN ZECH:
All right.
Clear inspections.
All 18 ri.jht.
Thank you very much.
19 Dr. Young, perhaps you could help me with this one.
20 on the solubility of polonium' microspheres, if they were 21 ingested or inhaled or otherwise taken into the body, do we 22 have any indication that they would be soluble, and if so, what 23 would be the result?
24 DR. YOUNG:
The microspheres have been studied both 2S commercially and in laboratory animals.
The only area.that we
30 1
think would be a'ny problem would be in the hydroc'holoric acid 2
in the stomach.
Based on the information that your agency 3
provided in regards to acid solubility, we are looking at below 4
a tenth of a percent leaching from this in months.
5 CHAIRMAN ZECH:
What would that do to the human body?
6 DR. YOUNG:
That would essentially be negligible.
7 There should not be any detectable radioactivity that would be 8
released in the -- the result is insignificant.
9 CHAIRMAN ZECH:
All right.
10 MR. BERNERO:
I might add to that, Mr. Chairman, we 11 also have some results from our own lab in Idaho, where they 12 have taken pristine microspheres and done solution tests for 40 13 hours1.50463e-4 days <br />0.00361 hours <br />2.149471e-5 weeks <br />4.9465e-6 months <br /> in Coca cola and beer, and have found negligible 14 solubility.
15 CHAIRMAN ZECH:
I see.
Are we still doing more of 16 those tests now?
17 MR. BERNERO:
Yes.
More tests are going on, I 18 believe.
19 CHAIRMAN ZECH:
And Dr. Young, are you involved in 20 those tests, too?
2)
DR. YOUNG:
No, that is being done in your 22 laboratories, but we rely very heavily on the work that's been 23 done with concentrated hydrocholoric acid, since that study has 24 shown that there is less than a tenth of a percent of 25 solubility.
\\
31 1
CHAIRMAN ZECH:
Well, we are providing the FDA with gs j
2 the --
3 MR. BERNERO:
Yes.
The FDA has the information.
The 4
licensing basis of this device, the microsphere, included 5
extensive solubility data and that included hydrocholoric acid 6
stronger than beverages 7
DR. YOUNG:
I think we used 6 normal or something 8
like that.
~
9 MR. BERNERO:
A hundred normal.
It's a pH of 2.
And 10 that is pretty acid.
You wouldn't have a very good stomach if 11 you --
12 DR. YOUNG:
I think there is not a problem from what 13 we can see from the work that was done as part of your license.
14 CHAIRMAN ZECH:
All right.
15 DR. YOUNG:
The ability to -- and also it should be i
16 emphasized that transit time for this going from the mouth out 17 into the feces is probably on the order of two to four days.
18 So it's not going to reside any period of time, and with that 19 very low dissolution rate, it's a negligible risk.
20 CHAIRMAN ZECH:
All right.
Just to make sure that I 21 am clear on all this, do our orders that we have got out that 22 are currently drafted or have been issued cover all of the 23 polonium-210 static eliminator devices that have been 24 distributed by any licensee that we are aware of?
25 MR. BERNERO:
No.
They cover only the polonium-210 i
~
32 1
' static elimination devices that 3M has distributed under the
- g-2 NRC license.
They do not apply to this company in California 3
that Region V just spoke of, and they do not apply to the 4
polonium-210 devices that I mentioned the New York company has.
5 CHAIRMAN ZECH:
All right.
But I presume that as you 6
are investigating those companies --
7 MR. BERNERO:
Yes, certainly.
8 CHAIRMAN ZECH:
-- if you find any need.to put out a 9
similar order, you will do so?
10 MR. STELLO:
Excuse me, Mr. Chairman.
You recall 11 both of those companies are in agreement states?
12 CHAIRMAN ZECH:
Yes, I understand that.
13 MR. STELLO:
The orders would --
14 CHAIRMAN ZECH:
But we'd make sure that --
15 MR. BERNERO:
Except through an administrative 16 peculiarity, the California one is actually an NRC license.
17 CHAIRMAN ZECH:
All right.
Well, in any case, we 18 want to make sure that we-have covered all the bases.
.i 19 MR. BERNERO:
We are following up with vigor to make 20~
sure that we have all of the bases and we tsre also looking at 21 the other potentially relatable licenses.
22 CHAIRMAN ZECH:
And how about the possibility of any 23 of these devices being exported to other countries?
4 24 MR. BERNERO:
What we have done, in the -- it gets 25 kind of tricky, because under our regulations, Part 1.10
.r.,.,
,~.
y. - - - - -,
a v,
33
-(
1 authorizes export.
Now what'we did in the order to 3M, we 2
directed 3M not only to report to the users about these orders 3
-- you know, to send these orders to the users, but to send 4
them to the international distributors.
So that the 5
information is there.
It gets a little trickier if you want to 6
now take action against the user in a foreign country.
7 MR. PARLER:
It does get tricky.
We have no 8
jurisdiction over the use in a foreign country that I know 9
about.
10
[ Laughter.)
11 MR. PARLER:
But we can tell the international 12 community, the IAEA, about the problem, et cetera, et cetera.
13 We can seek cooperation, but we have no jurisdiction that I am 14 aware of outside of our borders.
15 CHAIRMAN ZECH:
But we should certainly inform them.
16 MR. BERNERO:
Except the FDA has a concern.
17 MR. PARLER:
I was thinking just about the Nuclear 18 Regulatory Commission, under the Atomic Energy Act and Energy 19 Reorganization Act.
20 DR. YOUNG:
Mr. Chairman, we would be able to reach 21 that from our regulatory mode.
And what we have done is the 22 following two things:
23 We have notified the State Department so that we 24 could work through this and have that through the networks, and vj 25 then we are beginning through our network of other regulatory 4
e
34 7_ d 1
agencies in the countries that we would identify as we get 2
information from either 3M or NRC, we will use our networks to 3
let those countries know of the problems that we have.
So that 4
is already underway.
That's a significant issue, because we 5
can't just rest on the United States territory.
We have to 6
look at the other parts of the world.
7 I might also add on another issue, when FDA does its 8
analyses, in addition to doing ours, the way cur system works 9
is we require the company who has been the consignee or whom 10 this device has been sold to, to do a large number of assays, 11 and then our assays are done as a check against the corporate 12 assays.
13 So many, many more assays have been done beyond the 14 1300 that I mentioned earlier.
15 CHAIRMAN ZECH:
All right, fine.
16 DR. YOUNG:
So that we are continuing to look to make 17 sure there is no safety problem.
We don't see anything here at 18 this point.
19 CHAIRMAN ZECH:
Okay, fine.
Well, I think whatever 20 we come up with here, too, would be certainly of great interest 21 to the International Atomic Energy Association, and I think we 22 should at least keep them informed, and I presume that we 23 intend to do that.
24 MR. STELLO:
Yes, sir.
. \\.
25 CHAIRMAN ZECH:
Okay.
35 7.,k Are there any other questions?
Commissioner Carr?
l 2
Commissioner Bernthal, do you have any before we 3
conclude?
4 All right.
If not, we understand that the health 5
threat in this case is low, as we have been told several times.
6 DR. YOUNG:
That is correct.
7 CHAIRMAN ZECH:
Especially since the polonium is 8
tightly bound in the microspheres and it's certainly unlikely 9
to result in an appreciable exposure to anyone, even in the 10 probable event that someone were to ingest them.
11 DR. YOUNG:
That's correct.
12 CHAIRMAN ZECH:
I presume that's what we are saying.
13 However, it seems to me that even recognizing this, 14 that we have a responsibility to do all we can within our 15 authority to assure that these devices do not pose any hazard 16 to the public or to workers.
17 DR. YOUNG:
That's correct.
18 (Commissioner Roberts entered the room at 2:58.)
19 CHAIRMAN ZECH:
And I again certainly urge the Staff 20 to work very closely with the FDA, and with our agreement 21 states, to follow up aggressively on any and all leads to 22 assure that we are doing all we can to protect the public 23 health and safety.
24 We certainly expect that the Staff will continue to v.,
25 keep the Commission fully informed of all the actions that are
~. _
36 7,
1 taken on this particular matter.
2 Are there any other questions?
3 Commissioner Roberts, do you have anything before we 4
conclude?
5 All right.
Well, thank you very much for a very fine 6
briefing.
Dr. Young, thank you for being with us.
7 DR. YOUNG:
Thank you.
8 CHAIRMAN ZECH:
We stand adjourned.
9 (Whereupon, at 3:00 o' clock p.m.,
the meeting was 10 adjourned.)
11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
1 2
REPORTER'S CERTIFICATE 3
4 This is to certify that the attached events of a 4
5 meeting of the U.S. Nuclear Regulatory Commission entitled:
6 7
TITLE OF MEETING: ' Briefing on Static Elfmination Problems 8
PLACE OF MEETING:
Washington, D.C.
9 DATE OF MEETING: Thursday, February 18, 1988 10 11 were held as herein appears, and that this is the original.
12 transcript thereof for the' file of the Commission taken C
13 stenographically by me, thereafter reduced to typewriting by 14 me or under the direction of the court reporting company, and 15 that the transcript is a true and accurate. record of the 16 foregoing events.
17 A
_ _ _ _ _ _ _,f_ _ g,. '
.~ '> ( ' _.
18 r
, g.,
19 20 21 22 Ann Riley & Associates, Ltd.
23 I
24 25 x..j
,.--.-n.-
g e
D 9
7 9
e BRIEFING ON STATUS OF P0-210 STATIC ELIMINATOR ACTIVITIES FEBRUARY 18, 1988 i
e
BASIS FOR GENERAL LICENSE - STATIC ELIMINATORS 10 CFR 32.51 DEVICE CAN BE SAFELY llANDLED BY PERs0NS NOT HAVING RADIOLOGICAL PROTECTION TRAINING AND
^
UNDER ORDINARY CONDITIONS OF USE, RADI0 ACTIVE MATERIAL WILL NOT BE.
RELEASED AND PERSONS WILL NOT BE EXPOSED EXTERNALLY IN EXCESS OF 10 PERCENT NRC LIMITS (PART 20)
AND UNDER ACCIDENT CONDITIONS, UNLIKELY TO CAUSE INTERNAL AND EXTERNAL PERSON DOSE IN EXCESS OF NRC LIMITS (PART 32) 3M LICENSE ORIGINALLY ISSUED IN 1965 UNDERSTOOD P0TENTIAL FOR LEAKAGE, NOT UNDER ORDINARY CONDITIONS LICENSE EXPANDED TO MULTIPLE DEVICES INCREASED REPORTING REQUIREMENTS SINCE 1978 1
i
.m m.
c; MICR0 SPHERE Zr P 0 sphere 2 7 (zirconium pyrophosphate)
Po-210 absorbed in outer regions Sphere with Po-210 absorbed within is fired at 700*C Thin Ni coating i
~
{
Density 2-3 Gm/CC i
22-43 um
~~ ~
Melting Point >1500*C DIAMETER (About. 001 in.)
Low Solubility a
e e
i i
i i
l 3M CHRONOLOGY - 1 JAN. 21 ASHLAND CHEMICAL CO. REPORT JAN. 22 NRC AT EASTON PLANT JAN. 25 ORDER #1 A.
SUSPEND DISTRIBUTION OF 902, 902F, 906, AND 908 B.
INFORM USERS / REMINDER OF NOTICE REQUIREMENTS C.
SEND COPY OF INF0. NOTICE (B) TO RA-III D.
TEST DEVICES AND SUBMIT PLAN BY FEB. 8 E.
ANALYZE CAUSES JAN. 22 - FEB. 5 MORE FAILURE DATA RECEIVED FEB. 5 ORDER #2 (CONFIRMATORY)
REMOVE 902, 902F, 906, AND 908 FROM FBCP PACKAGING
\\
t W
3M CilRON0 LOGY - 2 FEB. 8 3M REPORT AND "PLAN" VERY LITTLE DATA FOCUS ON ENVIRONMENTAL CAUSES MINIMAL PLAN FEB. 11 3M/NRC/FDA MEETING AT R-III 3M TOP MANAGEMENT PRESENT VERY LITTLE MORE FROM 3M EXCEPT DECISION ON ALL MODELS IN FBCP AND NEED YOUR DATA NRC FOCUS ON WHETilER TilIS EVIDENCE Sil0WS THAT ALL DEVICES ARE NOT GENERALLY LICENSABLE FDA FOCUS ON FBCP FRODUCT SAMPLING AFTER REMOVAL l
AGREED TO FEB. 19 3M/NRC/ STATES MEETING AT 3M TO P0OL DATA 3M AGREED TO SUBMIT ACTION PLAN BY FEB. 26 FEB. 5 - FEB. 12 MORE FAILURE DATA 0 tiler MODELS l
FEB. 12 ORDER #3
- REMOVE ALL MODELS FROM FBCP PRODUCTION AND PACKAGING I
- s i
g r
s
\\.
TASLE A Fage 1 t
3M MODEL 902, 902F, 906 and 908 STATIC ELIMINATOR TEST DATA I
1
-Industry 902 902F 906 908 category Pass Fall Pass Fall PASS fFall Pass Tall (1)
Bo_ttling 14 12 16 9
ccanetics 23 1
I Klectronics 89 1
220 3
93 0
53 0
l 30(4)
Food 2.
0 3(5)
M; dical 36 0
2 0
14 0
=
Photographic 42 0
33 1
28 0
~
~
Paper 3
0 1
0 3
0 Printing 26 0
33 0
9 0
Other(6) 17 1
l 2
0 52 0
'6 1
F 3_
totals 215 2
223 3
283(2) 14 129(3) 10 i
l i_
e l
I I
1 1
t I
_e-,-
e_,-_-
- - - - ~ ~. - -
1
3M PLAN - FEBRUARY 8, 1988 BASED ON Tile FINDINGS OF THIS STUDY, 3M INTENDS TO TAKE THE FOLLOWING ACTIONS:
~
1.
REVIEW THE LIST OF DEVICES TilAT WERE RETURNED IN 1987 AND HAVE TRAINED AND SUITABLY EQUIPPED STATIC ANALYSTS VISIT CUSTOMER SITES WHERE TESTING OF Tile RETURNED DEVICES INDICATES POTENTIAL PROBLEMS.
2.
REVISE Tile PRODUCT LITERATURE TO REINFORCE Tile WORDING REGARDING THE TYPE OF ENVIRONMENT WillCil MilST BE MAINTAINED TO PREVENT FAILURES.
3.
PROVIDE REFRESHER TRAINING TO STATIC ANALYSTS TO BE CERTAIN THAT CUSTOMER APPLICATIONS ARE THOROUGilLY EVALUATED BEFORE LEASES-ARE SIGNED.
3M WILL CONTACT Tile CUSTOMER BEFORE LEASES ARE RENEWED TO BE CERTAIN THE APPLICATION llAS NOT CliANGED.
4 4
g e
l 6
9
1-
- i
.n 4
Data on Returned Devices from 3M Records f rom 3M Reports
- P.odel fio. Lea kir.g ht. Le6 king No. Returned (All)
.(Undama9ed) (Damaged) 1986 1986 7-.
g 902/902F 13,138 5.(0.04%)
0 1
e
~
62 (0.7%
8 0
ij906 8,718.
908.
1.990' 17 (0.8%)
o
.0 23.846 57%
315/210/220 11,050 95 (0.9%)
17 7.
r,
[
203 93 0
0 0
3 204 787 L(0.9%)'
0
'0 v-.
205 2.292 0
0 0
206 175 1(0.5%)
O C
14.397 34%
.3 905 2,070 0
0 0
907 668 5 (0.8%)
0 0-C 9
909 808 0
0 0
7,546 8%
41,789
- Tato from 1985 and 1986 Reports
\\
4
February 17, 1988 LIST OF SITES WITH FAILED DEVICES +
PRODUCT TYPE OF TEST COMPANY LOCATIDN PRODUCT RESULTS 1.
KTI Carrollton, TX chemicals
-o-Pos 2.
KTI Sunnyvale, CA chemicals 3.
Xicer M11pitis, CA chemicals 4.
Coca Cola Dallas, TX beverage
- -NDA, -n-NDA 5.
Coca Cola Dallas, TX beverage
- -NDA, -o-NDA
~6.
Coca Cola Fort Worth, TX beverage
-NDA, o-NDA 7.
Coca Cola Needham, MA beverage
-NDA 8.
Anheuser Busch St. Louis, M0 beverage
- -NGA i-NOA 9.
Custom Photo Austin, TX Film
-o-Pos, 20,000cga 10..Ashland Chemical Easton, PA chemicals
-o-NDA
- 11. Ashland Chemical Dallas TX chemicals
-o-Pos, 200PCi/1
- 12. McDonnell Douglas St. Louis, MO 13 Block Drugs Dayton, NJ denture
- -NDA adhesive
- 14. Ford Motor Co.
Milan, MI
- 15. Anteuser Busch lacksonville, FL beverage
- 16. Avon Morton Grove IL cosmetics
- 17. Ross Labs Div.
Casa Grande, AZ food, similac
- -NDA.
of Abbott Labs.
- 18. Coca Cola Phoenix, AZ beverage
- -NDA -#-NDA
- 19. Paul Flum Ideas St. Louis, MO
- 20. Best Food Urlt Argo, IL
- 21. 3M Ames, IA
- 22. Pepsi Cola Tulsa, OK beverage
-#-MDA
- 23. Coca Cola San Leandro, CA beverage
- 24. Block Drug Ibsecao, PR shampoo (Reedoci
- 25. CREST Photo Labs.
Pawtucket, RI developing
- 26. South Atlantic Bishopville, SC beverage Canners (Coke)
- 27. Photo Finish McColl, SC developing t
Pos= Positive Results
- = Test performed by FDA i
NDA= NO DETECTABLE ACTIVITY i= Test performed by Medi Trace Labs.
o-Test performed by Agreement States cr General Licensee Contractors
+ Contamination at these fr.cilities exceeded 0.005 uCi -
11,000 DPM
l l
I l
a February 17, 1988 LIST OF SITES WITH FAILED DEVICES +
l PR0bOCT l
TYPE OF TEST C04PANY LOCATION PRODUCT RESULTS
- 28. Hygela Coca Luia Pensacola, FL beverage
- 29. Ford Motor Co.
Ottca, MI paint
- 30. Dial Corp Ft. Madison, IA microwave lunch packages
- 31. Pro Corp Florence, MA plastic cases used on PC's l
- 32. K-Mart Garland, TX process film
[
- 33. Xerox Corp Richardson, TX
- 34. Micro Technclogy Boise, MD electronic chips
- 35. Mii)er Container Milan,.IL
- 35. McLaaghlin Body Co.
E. Moline, IL
- 37. Moto ?hoto horth Dartmouth, film MA
- 38. Ross Laboratories Alta Vista, VA food supplement
- Poj, 222,000 dpm (1 microsphere)
- 39. Super Photo New Orleans, LA developing Pos= Positive Results
- = Test performed by FDA IWA= NO DETECTABLE ACTIVITY f= Test performed by Medi Trace Labs.
e - T:st performd by Agreament States or General Licensee Contractors
+ Cor.tamination at these facilities exceeded 0.005 uCi -
11,000 DPM
s CURRENT SAFETY CONCLUSION i
BASED ON Tile ANALYSES AVAILABLE AT THIS TIME, EVEN IF MICR0 SPHERES GAINED ACCESSTOCONSUMIlRPRODUCTS,IT.ISUNLIKELYTHATTHEREWOULDBEASIGNIFICANT llEALTil HAZARD TO Tile PUBLIC.
NEVERTHELESS, IN ORDER TO MORE FULLY EVALUATE THE POTENTIAL SAFETY SIGNIFICANCE, SAMPLES OF CONSUMER PRODUCTS RESULTING FROM TilESE MANUFACTURING PROCESSES ARE BEING ANALYZED BY NRC AND FDA.
e 1
e
l FEBRUARY 18, 1988 ORDERS l
TWO ORDERS TO 3M TO GENERAL LICENSEES SUSPEND TRANSFER'AND llSE RETURN TO 3M FOR TEST EXCEPTIONS FOR SAFETY 5
4 4
0 t
b
i 3M,0RDER A.
SUSPEND TRANSFER OF DEVICES B.
IMMEDIATELY NOTIFY GENERAL LICENSEES DISTRIBUTE GL ORDER C.
INSTRllCT USERS TO RETURN DEVICES ASAF BUT NO MORE TliAN 90 DAYS D.
TEST RETURNED DEVICES FOR LEAKAGE NOTIFYbSER,NRC, STATES E.
STATUS REPORTS (30-DAY)
Sil0W CAUSE IN 60 DAYS WHY LICENSE SHOULD NOT BE REV0KED h
a
9 GL' ORDER
~
A.
SUSPEND USE OF DEVICES-B.
SEND DEVICES DACK TO 3M WITHIN 90 DAYS C.
TEMPORARY CONTINUATION OF USE POSSIBLE ESSENTIAL FOR SAFETY 1
WRITTEN APPROVAL 0F NRC OR STATE UNDER SURVEILLANCE TO BE SPECIFIED
~
NOT FOR FBCP OR MEDICAL DEVICES PUBLISilED IN FEDERAL REGISTER DISTRIBUTED UNDER ORDER T0 3M 9
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TPAMSMITTAL TO:
Document Control Oesk, 016 Phillips 0
l ADVANCED COPY TO:
The P;blic Document Room Ad>[RI
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DATE:
j FROM:
SECY Correspendence a Records Branch R
j Attached are copies of a Commission meeting transcript and related meeting g
document (s). They are being forwarded for entry on the Daily Accession List and i
placement in the Public Document Room. No other distribution is requested or required.
G Meeting
Title:
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Open N Closed Meeting Date:
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- 1. TRANSCRIPT 1
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- PDR is advanced one copy of each document, two of each SECY paper.
C&R Branch files the original trarscript, with attachrents, withcut SECY
- papers, E
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