ML20196B579
| ML20196B579 | |
| Person / Time | |
|---|---|
| Issue date: | 02/08/1988 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 8802120012 | |
| Download: ML20196B579 (77) | |
Text
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
Title:
Briefing on Static Elimination Device' Problems Location:
washincton, D. c.
Date:
Monday, Februery 8, 1988
(
Pages:
1 - 57 i
Ann Riley & Associates Court Reporters 16251 Street, N.W., Sulto 921 Washington, D.C. 20006 (202) 293-3950
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2 3
4 5
6 This is an unofficial transcript of a meeting of the 7
United States Nuclear Regu l a t ory Conim i ss i on he l d on s
2/08/88 In the Commission's office at 1717 H Street, 9
'fi.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
/'(
12 inaccuracles.
13 The transcript is intended solely for general 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 i
16 matters discussed.
Expressions of opinion in this transcript L
17 do not necese,arily reflect final determination or beliefs.
No 18 pleading or other paper may be filed with the Commission in 19 any proceeding as the result of or addressed to any statement 20 or argument contained herein, except as the Commission may 21 authorize.
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UNITED STATES OF AMERICA 0
NUCLEAR REGULATORY COMMISSION 3
4 5
BRIEFING ON STATIC ELIMINATION DEVICE PROBLEMS 6
7 8
PUBLIC MEETING 9
10 11 Nuclear Regulatory Commission 12 Room 1130 13 1717 H Street, Northwest 14 Washington, D.C.
15 16 Monday, February 8, 1988 17 18 The Commission met in open session, pursuant to 19 notice, at 1:40 o' clock, p.m., the Honorable LANDO W.
- ZECH, 20 Chairman of the Commission, presiding.
21 22 COMMISSIONERS PRESENT:
23 LANDO W.
- ZECH, Chairman of the Commission 24 THOMAS M. ROBERTS, Member of the Commission 25 FREDERICK.M. BERNTHAL, Member of the Commission
G 3
1 PROCEEDINGS I
2 CHAIRMAN ZECH:
Good afternoon, ladies and gentlemen.
3 I understand we need a vote, Mr. Secretary, to hold 4
this meeting on less than one week's notice; is that correct?
5 MR. CHILK:
Yes, we do, sir.
6 CHAIRMAN ZECH:
Do I have a vote from my fellow 7
Commissioners, please?
8 COMMISSIONER BERNTHAL:
Aye.
9 COMMISSIONER ROBERTS:
Aye.
10 CHAIRMAN ZECH:
Aye.
11 The purpose of the meeting this afternoon is for the 12 Commission to receive an information briefing on the use of 13 static eliminators containing polonium-210 and to discuss the
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14 effects on public health and safety.
15 Commissioners Carr and Rogers are not present this 16 afternoon, and I understand that Commissioner Bernthal has to 17 leave at 2:20.
18 The NRC Staff will discuss actions that have occurred 19 since the initial detection of contamination in late January of 20 this year, as far as our notification is concerned.
The Staff 21 will also discuss actions that have been taken and further 22 actions contemplated.
23 I understand that Dr. Frank Young, Commissioner of 24 the Food and Drug Administration, is with us today, and, Dr.
25 Young, ye appreciate very much your being with us.
We welcome
2 1
STAFF AND PRESENTERS SEATED'AT THE COMMISSION, TABLE:
2 3
S.
CHILK 4
W.
PARLER 5
V. STELLO 6
F. YOUNG 7
H. THOMPSON 8
D. CUNNINGHAM 9
10 SPEAKERPHONE PARTICIPANTS:
11 12 REGION III:
13 B. DAVIS 14 B. MALLETT 15 D. SRENIAWSKI 16 17 REGION I SPEAKER 18 REGION II SPEAKER 19 20 21 22 23 24 25 w
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you to our agency, and we appreciate the assistance.that you 2
have been providing to the Nuclear Regulatory Commission in 3
these past few days regarding this important matter.
4 DR. YOUNG:
Thank you.
5 CHAIRMAN ZECH:
The Commission has called this 6
meeting on short notice because of the importance of the matter 7
and the desire of the Commission to be fully informed and to 8
ensure ourselves that the actions so far taken by the Staff are 9
appropriate.
10 I should emphasize at the outset that I have been 11 informed that at this time there has not been found any 12 evidence of radiation contamination of any consumer product.
13 We want to hear that today from those at the table, but that's 14 what I have been informed.
15 Based on the analysis available at this time, even if 16 microspheres gained access to consumer products, I am further l
17 informed that it is unlikely that there would be any 18 significant health hazard to the public.
Nevertheless, in 19 order to more fully evaluate the potential safety significance, 20 samples of consumer products resulting from these manufacturing 21 processes are being analyzed by the Nuclear Regulatory 22 Commission and the Food and Drug Administration.
The NRC and 23 the FDA will continue to work with the states and with the 24 companies involved to give us further assurance that consumer 25 products are not contaminated.
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5 1
The Commission, of course, wants to ensure that we 2
are doing all that we can to protect the public health and 3
safety, including the safety environment of the workers.
-4 Before we begin, do any of my fellow Commissioners 5
have any opening remarks to make?
6 (No response.)
7 CHAIRMAN ZECH:
Commissioner Rogers, being unable to 8
be here today, has asked me to read for the record a statement 9
that he wishes to submit, and I will read it now, and I quote 10 "As you know, I am on planned travel February 8th u,w 11 9th, 1988, and am unable to attend the Commission meeting whica 12 was scheduled.on February the 7th.
I would appreciate your 13 reading for the record the following statement on the polonium-14 210 leakage problem in, static elimination devices."
15 And I continue the quote:
"I strongly support the 16 vigorous actions taken by the agency on January 25, 1988 with 17 the general licensee, Minnesota Mining & Manufacturing Company, 18 to cease further distribution of these devices and conduct an 19 exploratory test program when the agency learned of the initial 20 instance of leakage and contamination in Pennsylvania and Texas 21 of the polonium-210 sources in 3-M's compressed air static I
22 eliminator devices and subsequently on February the 5th, 1988, 23 with evidence of greater leakage and potential of contamination 24 of these sources in certain food, beverage, and pharmaceutical 1
l 25 industries became available to 3-M and to NRC inspectors at 3-M i
Q 6
1 facilities.
2 "The prompt issuance of an NRC order on February the 3
5th to 3-M to recall all of the approximately 22,000 static 4
elimination devices which had been losued in 1987 and to notify 5
the Food and Drug Administration and the Office of Governmental 6
and Public Affairs for distribution of the order to the 7
agreement states was, in my opinion, an example of effective 8
and responsible federal regulatory action in protecting public 9
health, even though preliminary assessments by the agency of 10 potential health effects to the public from presently known 11 instances of leakage did not show them to be of consequence.
12 "The recall order in no way constrains the agency 13 from taking further regulatory action in this matter as 14 appropriate additional information on leakage or contamination 15 by the devices becomes available from the general licensee and 16 the agency's onsite inspectors.
I 17 "It is equally important that the agency protect 18 industrial process workers from potential low-level 19 occupational radiation exposure, as well as the general public 20 as consumers of food, beverage, or pharmaceutical products.
As 21 such, the defective static eliminator situation warrants 22 continued close investigation and cooperation by the NRC and 23 the Food and Drug Administration and prompt disclosure of the 24 facts to the public," signed Kenneth C. Rogers, Commissioner, 25 unquote.
7 l'
With that, Mr. Stello, you may proceed.
~
2 MR. STELLO:
Thank you, Mr. Chairman.
3 What I would ask, if possible, if we could depart 4
from our usual procedure in triefing by going to first some 5
summary statements of where we are within the NRC and within 6
FDA.
7 Commissioner Young, who as you have already pointed 8
out has broken away from a very busy schedule and will need to 9
leave here in about 45 minutes, so in order to provide an 10 opportunity for the Commission to hear his views on this matter 11 and perhaps ask any questions that you may want to, I'll ask 12 Mr. Thompson to give a very short summary of where we are, and 13 then I will ask Commissioner Young to do the same, and then 14 perhaps if you would, we could go directly to any questions you 15 may have of FDA at that point before Commissioner Young has to 16 leave.
17 CHAIRMAN ZECH:
That sounds fine.
18 MR. STELLO:
If that's acceptable.
19 CHAIRMAN ZECH:
Please proceed.
20 MR. STELLO:
Hugh, why don't you try to hold it to a l
21 few minutes for a summary, and then we'll get into the details 22 after that.
23 MR. THOMPSON:
Thank you, Mr. Chairman.
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24 Through the inspection activities of the NRC Staff, 25 the agreement states, and the affected licensees, there have t
8 1
been approximate'ly 23 facilities identified-that have f.,
2 contaminated facilities or have contamination levels sufficient 3
to be at the NRC reporting level for these type devices.
We 4
have sampled products that would be potentially consumed by 5
humans, individuals.
The companies have sampled and the FDA 6
has sampled.
He have done calculations based on our knowledge 7
of the performance of the polonium in the microsphere 8
container, and we have concluded at this time first, no product 9
that is consumed by the public in the form of food, drugs, or 10 pharmaceuticals has been found to be contaminated, but even if 11 there were some of these small microspheres were to get into 12 those products, in our judgment, it is unlikely that they would 13 be a significant health hazard.
14 We do believe that the continued inspection 15 activities that we are doing and that we are conducting today 16 will find other facilities likely to be contaminated and that 17 additional products will need to be sampled as we go through 18 the activities of following up on the additional devices and 19 their applications in the industries.
20 MR. STELLO:
Mr. Chairman, I would add one point to 21 what Mr. Thompson said to give some scope.to this.
My 22 understanding is that the number of devices that are involved 23 are on the order of 50,000 devices.
They are used in a large 24 spectrum of facilities for a variety of purposes, some of which 25 are directly related to safety functions performed by the
9
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1 devices.
2 We have concentrated our efforts, along with those of 3
the FDA, to direct our attention to.those devices which, if 4
they fail, could find a way into the public domain through food 5
or related products in the cosmetic or whatever industry.
6 There is a great deal that remains to be done, and later this 7
afternoon we'll be giving you a scope of what further action we 8
will need to take with respect to dealing with this fairly 9
large number of devices and how to approach that in a realistic 10 manner.
11 With that, I'll turn to Dr. Young.
12 CHAIRMAN ZECH:
All right.
Dr. Young, you may 13 proceed.
14 DR. YOUNG:
Thank you very much, Mr. Chairman.
15 I would like to provide some scope of the information 16 that we have received to date, and I appreciate the cooperation 17 that your agency has provided to us..
18 We were able to be notified quite early upon receipt 19 of the information by the Nuclear Regulatory Agency, and we 20 have the list of the 23 plants that had been referred to us.
21 of those plants, 13 are in the food / drug / cosmetic device arena 22 that we are involved in.
We have taken 32 samples from that 23 material to date.
Ten of the samples have been completely 24 analyzed, and in none of the samples was there any evidence of 25 radioactivity.
10 1
We feel that is a very high priority for us to
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continue to interact closely with the Nuclear Regulatory 3
Agency, and we shall do this to be sure that we keep your 4
Commission fully informed, and I have been pleased with the 5
partnership that we have had in analyzing samples.
The samples 6
have been both analyzed by our two organizations, as well as 7
states and industrial corporations.
8 I would also agree that there is no significant 9
hazard likely to be there on the products, but when one is in 10 such an early phase, we're really taking the extra steps to 11 look at each of the products.
I should point out that the 12 products will be exposed to human beings in different ways.
i 13 In the case of food, of course, one is looking for 14 the passage through the intestinal tract to see whether any of 15 the radioactive microspheres would be retained.
In the case of 16 things that are applied to the skin or mucosa, obviously the 17 radiation is going to be closest to the point of application.
18 So our strategy will vary somewhat within each of the products, 19 but it is our full intention to take the list that you provide 20 us with those products that are potentially contaminated, and 21 we will promise to look at each of these products and 22 communicate fully with you and with the press in regard to any 23 hazards that wc've found.
24 But I want to emphasize again, as I started, there is
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25 no evidence at this time of any radioactive contamination in
11 1
any of -the products related-to food, drugs, devices, and
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2 cosmetics.
3 Second, from what we know at this point of the type 4
of microsphere, the type of alpha radiation, that it is 5
unlikely that there would be a very significant herith effect.
6 But nevertheless, we don't want to leave any stone unturned, 7
and we will work on that as promptly as humanly possible.
8 CHAIRMAN ZECH:
Thank you very much.
If you could 9
remain with us for awhile, I might ask Mr. Thompson to go into 10 the briefing a bit, and if we may, we'll just interrupt and 11 perhaps, Dr. Young, direct any questions to you, knowing you 12 can't stay with us for the entire briefing very likely.
13 Is that all right with my fellow Commissioners?
14 COMMISSIONER BERNTHAL:
Fine.
15 MR. THOMPSON:
Thank you, Mr. Chairman.
16 I'm not sure whether my slide man is back there in I
17 the back or not.
I believe he is.
But he's learning the l
18 difference between the right side up and the wrong side.
19 CHAIRMAN ZECH:
Good.
20 MR. THOMPSON:
This is our training session here.
i 21 We do have passed out, I think, a set of the briefing 22 slides to you.
They were making a few last-minute l
23 modifications to reflect the infornation.
If I could, would you distribute the copies which are 24 25 a little bit better of the particular device to the
12 1
Commissioners, because I think~when the Xerox machine takes 2
this in its normal manner, it treats everything the same way.
3 (Slide.]
4 If I could this afternoon, I would like to talk a bit 5
about the device, what the problem was that we found with the i
6 device, the risk, which I think you've just heard som:
7 information on it, some of the actions that both the NRC, the 1
8 FDA, and the states have been taking in response to this 9
particular issue, and the future actions and issues that we l
10 think are critical for us to address this in an effective way.
11 (Slide.)
12 The device is about two inches long, and it is used 13 primarily in -- this is a 900 Series device that is produced by 14 the 3-M company, and it is used in airlines and in a multitude 15 of processes that we had identified earlier, just a few of the 16 processes.
17 The air will come in, as you can see from the 18 lefthand side, pass over the polonium-210 microspheres which 19 are bound in a slight epoxy -- that's about a two-inch long 20 device -- and pass out on the righthand side.
It could pass 21 out into an array of different types of configurations.
It 22 could go into an air manifold; it could go into a filtering l
23 system that would be used for the bottling of some various l
24 products, or it could be pretty much open just in a straight 25 line, so there is just a number of arrangements that it could
13 1
occur in.
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2 What we were having, as you can see, the microspheres would be bound right in that epoxy, and some of those 3
1 4
microspheres have been becoming dislodged and entering into the' L
5
. environment.
6 (Slide.')
i 7'
The microsphere itself is a ceramic, very hard 8
substance, zirconium pyrophosphate, in which a solution 9
containing polonium-210 is absorbed in it.
That sphere is then 10 fired up around 700 degrees Centigrade with a small -- a very 11 thin nickel coating as its particular characteristics.
12 The diameter is somewhere between 22 and 43 aicrons, i
13 a n d.i t ' s a f a i r l y d e n s e p a r t _i c l e.-
14 If yon lock at the next slide, I don't know that we i
15 have a slide on it, but in your handout you willisee a picture 16 of these microspherr.4 compared to the human hair That kind of 17 shows you a number of these things.
18 And the ner.t picture that you have in your handout is i
i 19 a micron electronic b!.ovup, magnification of what one of thocs 20 spheres actually would look like.
j 21 We will hava Lone copies of tliese for the public at i
j 22 the end of the briefing.
1 r
23 The initial everi occurred --
l 24 CHAIRMAN ZZCH:
Before you go on, aould you tell us i
25 just very briefly, I think it's important, that we're talking
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about polonium and not' plutonium.
Would you please give us a I
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2 very brief definition of polonium and perhaps the difference, 3
as I understand it, the chemistry and the radioactivity are i
4 completely different?
But I'd like you to tell us a little bit i
5 more about that, if you would very briefly.
6 MR. THOMPSON:
All right.
I'd like to turn to Mr.
7 Cunningham to do that.
8 CHAIRMAN ZECH:
Fine.
Just very briefly.
i 9
MR. CUNNINGHAM:
Polonium is found in nature.
It is 10 part of the decay chain of radium.
It's lower in the decay 11 chain than radon, for example, but it is part of the same dacay 12 chain, so it is found in nature.
But the polonium that is used 13 in these devices is made in a reactor because of the problems 14 of concentrating it from nature.
15 It is an alpha emitter, about 5 meb energy.
Alpha 16 particles will not normally penetrate the skin.
It is a i
17 relatively short half-life material, about 138 days.
l' 18 Plutonium, of course, is a heavier particle.
It does 19 have an alpha radiation.
It is a fissile material; polonium is 20 not.
It is very close to lead in the chemistry of the thing.
21 CHAIRMAN ZECH:
That's fine for now.
Thank you.
22 You may proceed, nr. Thompson.
l l
23 MR. THOMPSON:
Okay.
The initial event, as you 24 mentioned earlier, Mr. Chairman, did start with the Ashland 25 Chemical Company.
There was a customer of the Ashland Chemical
.. i
15 1
Company who had been detecting small amounts of alpha activity s
2 in some of the sulfuric acid in some of their products, ard.
3 they began to search around to try to identify how that 4
activity had been identified at their facility.
They started 5
last summer.
Toward November and December, as I understand it, 6
they concentrated their investigation on trying to eliminate 7
some of the chemicals that were supplied to them, and, in fac',
8 on January 21st, this particular company took a survey team to 9
the Ashland Chemical Company and identified the alpha 10 contamination at that facility.
11 COMMISSIONER BERNTHAL:
Hugh, let me ask one 12 question.
How pure is the material in these microspheres?
In i
13 other words, to what level can you assure that there are no 14 radioactive contaminants that might be longer-lived, for 15 example?
16 And by the way, plutonium is close to lead in the 17 periodic chart, but it's chemistry is not similar to lead, nor 18 is bismuth which is closer to lead.
I think that should be 19 mentioned.
It has quite a different chemistry.
20 The fact of the question, do we expect any 21 contaminants at all, or is this carrier-free material?
22 MR. THOMPSON:
I am not personally able to answer j
23 that question.
We do have the key Regions who have been 24 involved in doing the inspection activities at the facilities.
25 Region III, Bert Davis, do you have anyone who could
4-16 1
answer Commissioner Bernthal's question concerning the s
2 possibility of contamination on the quality control on the 3
polonium that's bound in these spheres?
4 CHAIRMAN ZECH:
We have Mr. Davis on the speaker, I 5
believe.
If you heard that, go ahead, please.
6 MR. DAVIS:
This is Bert Davis, Region III.
I'm 7
sorry that we cannot answer that right now, but if we can get 8
an answer for you, we'll provide it later.
9 CHAIRMAN ZECH:
Thank you very much.
10 MR. THOMPSON:
NRC was notified by the Ashland 11 Chemical company's consultant, who verified the contamination 12 of that product the next day, which was January 22nd, and 13 Region I then dispatched a team to the site.
We verified that 14 there was contamination at the Easton site, and the State of 15 Texas subsequently found additional contamina' tion on the 24th 16 of January, resulting in NRC issuing an order suspending the 17 distribution of these devices by 3-M on January 25th.
I'll 18 discuss in just a moment precisely what the purpose of that 19 order was.
20 CHAIRMAN ZECH:
1988.
21 MR. THOMPSON:
1988; yes, sir.
22 Two other of the Ashland Chemical plants showe' no 23 contamination.
l, 24 COMMISSIONER ROBERTS:
Well, I guess this is implied, i vs 25 Did those two other plants use this same device?
l
17 1
MR. THOMPSON:
Yes, sir.
I believe that is correct.
2 That's my understanding, that they used that device.
3 If anybody has other information that they didn't, 4
I'd like to know that.
5 The initial findings of that inspection, which was 6
done by Region I, was that in fact contamination was coming 7
loose from the polonium static air eliminators but appears not 8
to be dissolving.
We concluded that based on sampling of the 9
chemical companies' products, in which we found particulate 10 matters in that product as well as when we sampled the urine 11 from the workers which would give an idea of some aspect of the 12 material being in solution, dissolving in the stream, if it had 13 been inhaled -- not inhaled but if it had been ingested by the 14 workers, that it would be likely to be identified in that 15 sample.
16 Region I did hold the products of the Ashland 17 Chenical Company until we found through our sampling process 18 that those had been acceptable for industrial use and release.
19 COMMISSIONER BERNTHAL:
Let's see.
Your slip of the 20 tongue raises a question.
What about inhalation?
Even though 21 these things have quite a high density, they are terribly small 22 and presumably can become airborne.
Do we know anything yet 23 about the possibility of inhalation?
24 MR., THOMPSON:
We have looked at the aspect of i
25 inhalation and we are discussing the specific risk that is
18 1
associated with that.
Our initial judgment was that the 2
particles would likely not reach the critical parts of the lung 3
but I guess I would like to turn to Dr. Young who may want to 4
give us his judgments on the likelihood of those particles 5
being inhaled.
6 DR. YOUNG:
Your question is both an interesting one 7
and an important one.
The particles are very heavy.
8 Therefore, there will be a differont kinetic analysis required 9
for this in a particle which is fairly airborne.
10 We would not expect these to reach the alveolar sacs, 11 however, they would lodge somewhere either in the nasal 12 passages to the trachea, the bronchi, the brochials.
My 13 estimate would be that it would be more the smaller air 14 passages if they were to gain access to t un lung itself, but a 15 substantial number should be filtered out in the nose hairs.
16 Be that as it may, where they would lodge, they would 17 emit radiation in about a 5 to 10 micron track, which would 18 produce a substantial degree of ionization there.
Thus, it is 19 very important to determine whether the products themselves are 20 contaminated and what the likelihood of that would be in 21 introducing any risk to either workers or consumers.
22 The good news is to date, but yet on limited samples, 23 there is no evidence of contamination.
24 COMMISSIONER BERNTHAL:
Either by inhalation or
[
25 ingestion?
19 1
DR. YOUNG:
No evidence of contamination o' the I
t 7x 2
products.
In regard to the ingestion, the safety factor there 3
would be, as I have been told by our folks in the center for j
4 Radiation -- I'm sorry -- Devices in Radiological Health, it is 5
unlikely that more than one percent of the radioactivity would 6
be removed from the microsphere by acid and such, but 7
therefore, the comfort of it not being in the urine would 8
' indicate low amounts were taken in an'd not removed, but it does 9
not of course say whether or not any of the microspheres would 10 remain in the body or would pass out, because of the density, 11 it would be hoped that a substantial amount of these that were 12 ingested might clear the intestinal tract.
Of course, they 13 could lodge in villi, on things such as the appendix or other 14 areas.
15 Nevertheless, I think the key issue will be to 16 determine whether the products themselves are contaminated and 17 what the likelihood would be there.
18 COMMISSIONER BERNTHAL:
Wouldn't inhalation in your l
19 judgment be a greater health risk were that to occur or are you 20 unprepared to comment on that at this point?
21 DR. YOUNG:
I think it is very early in the analysis l
22 to know.
This could be said clearly; in the case of the l
23 product, it wil)' depend on what the product is as to the route 24 of exposure.
The use of a food would obviously be a l
l 25 gastrointestinal tract, only if it was a product that was used
20 a.
1 in a nasal spray or something like that, would you worry about 2
an inhalation route.
We can analyze that very rapidly by 3
looking at all the products.
4 For the worker, I think your question is more 5
relevant.
The fact that they are fairly heavy particles, they 6
would settle more rapidly than would the normal poly-dispersed 7
dust.
I do think there would be some concern and obviously as 8
a person concerned with health, all of us would be concerned 9
about that.
Yet, there is not sufficient evidence to give the 10 magnitude at this time.
11 CHAIRMAN ZECH:
In the facilities where we have found 12 contamination, has it been found, for example, on the floor or 13 is it in the air?
My question really is, Dr. Young, pointed to 14 the fact that you say this heavy material would tend to settle 15 on the floor.
Do we know where the contamination has been 16 found in the facilities?
17 DR. YOUNG:
I asked that question of Mr. Thompson and 18 he can add more to it.
From the information he gave me, the 19 particles are primarily on the floor areas and were able to be 20 picked up by swabs and not within the air in the rooms.
21 MR. THOMPSON:
That's the primary pattern.
I believe J
22 Region I may have some more specific details.
There have been 23 some contamination in a few places, particularly one of the 24 plants out in Arizona, where the contamination dropped about 25 25 feet from where the product was actually going, and there
21 1
turned out to be a pattern of about 10 feet diameter where the 2
large majority of the concantration was found and the 3
contamination was found, but there turned out to be small parts 4
of it in some of the printing oil that goes on these bottling 5
cans.
It was very difficult to clean up.
The assessment was 6
there were still particles but some of them had actually kind 7
of bounced and may have been carried onto small parts of the 8'
stairwell, parts of the machinery, some difficult areas to 9
clean up.
10 In general, Region I, I think you have done more 11 inspections than the others right now, is that the general 12 pattern you are finding, which would be. indicative of most of 13 it, that it is a floor type contamination?
14 REGION I SPEAKER:
In the case of Ashland, in the 15 Easton facility, that is correct.
The contamination is largely 16 on the floor.
It is on equipment that the devices were used 17 on.
In the case of Ashland, the devices were out of service 18 when we were up there so we were not able to take air samples 19 at the time the devices were being used.
The contamination 20 exists on floors ar.d surfaces and we have no indication that it 21 was airborne.
22 COMMISSIONER BERNTHAL:
Let me ask a related 23 question.
I only have ten minutes or so to go.
24 As far as we know, is the integrity of these 25 microspheres maintained in all of the contamination we found or
22 1
is there any evidence for them having been broken and material 2
escaping from them?
In other words, thus far, are we confining 3
the concern to the microspheres themselves or not?
4 MR. THOMPSON:
I don't think we can have specific 5
evidence precisely to address that point.
We have sent some 6
samples that we have.taken to our laboratory from microscopic 7
analysis to see that.
The judgment is that these spheres can 8
crack, can break up under certain circumstances.
The evidence 9
in the reports that were provided by 3M, if they do that, they 10 still maintain their structure, the polonium is not released, 11 it is just in a smaller type of ceramic charactaristic.
12 I think we did gtt some ten micron sized particles in 13 the Ashland Chemical, in the State of Texas, when they did some 14 of their measurements, which indicated that the thing doesn't 15 dissolve quicker, it stays in soluble characteristics even if 16 it were cracked up.
17 COMMISSIONER BERNTHAL:
Now you are talking about 18 ceramic and not about the nickel coating; right?
That would l
19 have very different dissolution characteristics or leaching 20 characteristics, I should say.
21 MR. CUNNINGHAM:
We do have leaching characteristics l
l 22 without the nickel coating on, still rather insoluble, no 23 solubility.
I l
24 MR. STELLO:
There seemed to be a question that 25 needed to be addressed.
Using the standard lung models, if you l
l
23 j
l 1
did breath in a particle, that came into the l'ung, I think it 2
would be useful to at least present the magnitude of the dose 3
we are talking about, because it is quite small.
4 MR. CUNNINGHAM:
In the lung itself, if we assume 5
that one of these microspheres of 30 microns diameter and a 6
tenth of a microcurie of polonium, did reach the lower region 7
of the lung, the alveolar sac, it would be about 4.8 rem to the 8
lung, which translates to in effect a full body dose of the 9
equivalent of about 830 millirem.
By way of perspective on 10 that, my recollection of the latest NCRP report is a person 11 smoking cigarettes, a typical cigarette smoker, gets about 6 12 rem to the lung per year, a large contribution being polonium.
13 If you broke that up into smaller particles, of 14 course, as the particles become smaller, the greater the chance 15 of it rsaching the lung, but the activity, the smaller l
16 particles go down by the cube, you break that sphere up.
It is 17 a change in characteristics.
18 That is our estimate for the lung dose.
19 COMMISSIONER BERNTHAL:
I think in fairness, I think 20 the Commissioner from FDA can probably enlighten us at greater 21 length than we are prepared to receive today, but my 22 understanding is that these things can be synergistic, both in 23 the case of radon in basements and the case of polonium 210 in 24 tobacco smoke and in this case, polonium 210 with other 25 synergistic materials, it could be much more dangerous than the 1
l
24 1
dose itself, or at least there'is some evidence, I think.
The g3 2
dose itself isn't the only thing to look at, as I understand 3
it.
Maybe you would like to comment.
4 DR. YOUNG:
I will only comment briefly on it and 5
would be delighted to provide more information.
I think the 6
key issue here is we are dealing with an alpha particle which 7
has an ionization track of about 5 to 10 microns and it is 8
somewhat different than delivering whole body radiation, 9
because you are looking at a point source, which is your 10 concern.
11 That is why I feel that the most appropriate thing to 12 do is to pull out all stops to determine whether the products 13 are contaminated.
That really is our best layer of safety.
If 14 we have a product contamination, then we have to go out and 15 deal with that immediately and that helps us on the speculation 16 because then we know where it is likely to be delivered and at 17 what part, if any, and thus, I am pleased to see that we are 18 getting the names of the plants, we are working together and we 19 are looking to see where product is.
I 20 You are absolutely correct, Commissioner.
You are 21 looking at the track of radiation and that's why we want to see 22 with all that in place.
The understanding that I have is even 23 if this was ingested and retained for a short period of time, i
24 we are dealing with relatively low levels of radiation and the 25 hazard is not significant.
I don't want the American people to
25 1
be alarmed at this point of investigation, that we have a 2
crisis of major import.
We are really trying to pull out all 3
stops to see that there is or is not any contamination of 4
products.
5 CHAIRMAN ZECH:
Before we go on, I know Commissioner 6
Bernthal must leave in a few minutes.
Do you have anything 7
else you would like to get into now?
~
8 COMMISSIONER BERNTHAL:
No.
I think I am finished 9
for the moment.
10 COMMISSIONER ROBERTS:
Can I ask a quick question?
11 CHAIRMAN ZECH:
Please.
12 COMMISSIONER ROBERTS:
Do we know that 3M is the only 13 manufacturer of this device?
14 MR. THOMPSON:
We know there is another nanufacturer 15 of a static eliminator device that has radioactive polonium in 16 it.
It is manufactured with a different process.
I believe we 17 do have an inspector -- it is licensed by the State of New 18 York.
I do believe we have an inspector up there today 19 evaluating and looking at that particular device.
It is a foil 20 construction whereas this one is an epoxy type construction.
21 We are not aware of any other leakage but we are investigating 1
22 and following up on that particular activity.
2 23 There are static eliminators that are non-radioactive 24 types.
Those devices are not part of our investigation at this 25 time.
26 1
MR. STELLO:
I think it would be important to point
_7 i
2 out that the company Mr. Thompson is referring to -- it should 3
be pointed out that the number of products involved are several 4
order of magnitudes less, like one or two percent of what we 5
are talking about at 3M.
It is a fairly small company.
6 CHAIRMAN ZECH:
We are going to look at that, too, I 7
presume.
8 MR. THOMPSON:
We are doing it as we speak.
There is 9
an inspector up there today.
It is an agreement state and that 10 effort is being coordinated through our agreement state 11 program, which in fact this has been a very close effort, not 12 only with the FDA but the agreement states and their inspection 13 activities to follow on the devices for which they have 14 regulatory oversight.
15 CHAIRMAN ZECH:
Proceed.
16 MR. THOMPSON:
Dr. Young, if there is anything else 17 you want to add.
I am starting to go into some of the details 18 of where we are.
19 DR. YOUNG:
Please go on.
I only want to be 20 responsive to any questions that you might have.
21 CHAIRMAN ZECH:
When you leave, can you have one of 22 your colleagues join us at the table?
23 DR. YOUNG:
Surely.
I will stay a few minutes 24 beyond.
I know this is an important issue.
I will try to stay 25 as long as possible..
4 -
27 1
CHAIRMAN ZECH:
Thank you.
We appreciate that very 2
much.
Proceed, Mr. Thompson.
3 (SLIDE.)
4 MR. THOMPSON:
Following our evaluation that in fact 5
these devices really were not performing as they were intended 6
to be, that is in the general licenses, we don't anticipate the 7
release of this radioactive material into the work environment
'r into a particular product.
We were focusing ~on the 8
o 9
individual area and the work product at that time was some 10 sulfuric acid.
11 We had a two pronged approach.
We sent a team from 12 Region III up to 3M to investigate that facility's records and 13 the history of the information they had available to them 14 concerning leaking devices.
This device had been licensed by 15 NRC for a fairly long period of time and we did not have a 16 broad indication of failures of this device.
17 CHAIRMAN ZECH:
When did we first license this 18 device?
l 19 MR. THOMPSON:
I am going to say 20 years; 1968.
As l
l 20 you know, these devices are renewed every few years, about 21 every five years.
I would want to point out sometime in the l
l 22 briefing today that in one of the review prscesses, in one of l
23 the reviews, there was concern expressed by the staff about 24 this particular type of incident occurring.
25 COMMISSIONER BERNT;IAL:
When was that?
28 1
MR. THOMPSON:
I believe it was'in May of 1976.
i 2
There was a realization at that time that use of this type of I
3 consumer product, the device could actually have a release of 4
these microspheres and they expressed some concerns with the 5
continued licensing of this device.
6 The record is not absolutely clear as to precisely 7
what was done, it is one of the follow up actions we will have 8
as to whether or not other devices may have a similar record of 9
review.
You should be aware that was part of the record when 10 we went back to review it.
11 MR. STELLO:
Mr. Chairman, I misspoke.
The license 12 was originally issued, according to a document I am referring 13 to now, on February 17, 1964.
14 COMMISSIONER BERNTHAL:
One last question and I am i
15 going to have'to run out the door.
I apologize.
I am trying 16 to visit some of the Tennessee Valley Authority plants.
'l 17 You have answered the other question I had.
I really 18 was interested in knowing whether you have an idea why these l
19 things came unstuck so to speak, and whether it is radiation 20 damage to the epoxy itself.
Has that been locked at?
Do you 21 have any idea yet what the cause was?
22 MR. THOMPSON:
We have been discussing potential 23 reasons for the cause of this device failure.
It is clear that 24 a soluble solvent, water, in. fact, in an environment will cause 25 the epoxy to fail to perform its intended function.
- However, a
j 29 gs there is at least one or two other applications in which they 1
2 appear to be in a very dry environment and in particular drug 3
companies of major concern that we will discuss later on, and j
4 in that particular case, there was no clear indication of why 5
there was a release in that device.
6 That particular company had another process line with 7
an ionizer installed in it.
They had a treatment of the 8
cooling of the air, they had some filtration activities and 9
maybe even some filters that seemed to provide a pure quality 10 of air that was passing over the epoxy.
However, that is the 11 first focus of the effort that we directed 3M to do, to ensure 12 that they evaluate the cause and understand the performance of f
13 this device prior to commencing any redistribution of this 14 series of a device.
l 15 COMMISSIONER BERNTHAL:
You are saying there were 4
16 units side by side with different air quality characteristics, 17 one of which failed and one didn't?
18 MR. THOMPSON:
I can't say side by side because I 19 have not been physically out in the field.
I understand there 20 is one plant in Piscataway, New Jersey, where the device 21 performed as intended.
The additional plant by the same i
22 company in Dayton, New Jersey, there were failures in that l
23 device and rather significant failures.
l 24 COMMISSIONER BERNTRAL:
I am sorry.
I have to go.
l l
25 Thank you very much and particularly you, Commissioner.
l
4 30 l
DR. YOUNG:
My pleasure.
I appreciate the 2
opportunity to help.
3 (Commissioner Bernthal left the briefing.]
4 MR. THOMPSON:
I would like to make sure Region III 5
and Region I get back on the line since I am beginning to talk i
6 about them.
7 CHAIRMAN ZECH:
Region III, are you on?
8 MR. SRENIAWSKI:
Region III is on.
9 CHAIRMAN ZECH:
Region I?
10 REGION I SPEAKER:
Region I is on.
11 MR. THOMPSON:
We had a major two pronged approach, 12 as I mentioned earlier.
One was for the Region III team to go 13 to the 3M licensee, to understand what type of information, 14 inspection records they had concerning the devices and their 15 use, with the thousands of licensed devices or a thousand of 16 these devices out there, we wanted to focus both our resources 17 and the resources of 3M on those things that had the most 18 significant safety issues with respect to public health and 19
- safety, i
20 In order to do that, I issued the order on January 21 25th that required 3M to notify all the customers who had this 22 type of device, that is the 902, 906 and 908 series, of the L
l l
leaking problems they were having.
We suspended distribution 23 24 of this device until there was an evaluation and approval by l
l 25 NRC to redistribute it, required them to develop a survey and l
l
\\
e 31 1
determine the scope and the significance of what needed to be
. s 2
done to arrive at the solution of why this particular device 3
was failing, to analyze specifically what was happening with 4
the Ashland chemical devices, where we had the failure.
In 5
fact, at that time that was the only failure we were aware of, 6
and also to provide NRC with a list of customers who had this 7
particular device.
8 COMMISSIONER ROBERTS:
Is there a question about the 9
ability to provide an accurate list?
10 MR. THOMPSON:
The computerized list of some 20,000 11 devices, I am sure there are some errors in the names and 12 addresses of people.
There was no question they provided the 13 list to us.
Whether er not all the information on that list 14 was specifically correct, I don't know.
Maybe Region III may 15 want to comment on the quality of the list they provided.
16 MR. DAVIS:
Mr. Sreniawski, who is our Section Chief i
17 and was up the.re, will answer the question.
18 MR. SRENIAWSKI:
That question was posed to the 3M l
19 representatives.
They said that to the best of their 20 knowledge, they had not double checked it, but there could be l
21 some small percentage of errors.
Wc are talking about the 22 20,000.
There could be some small errors, clerical errors that 23 would be present in any normal distribution list.
24 MR. THOMPSON:
Taking that list, we did some -- since 25 we talked initially on the current safety evaluation, I would i
1
e 32 1
like to go to the next slide.
2 (SLIDE.]
3 MR. THOMPSON:
Once we haA the list and while we were 4
at the site, we identi.fisd by inspection of the 3M records, 5
that they had devices which had failures, some in fact _in the 6
food, beverage and pharmaceu'eical industry, and we had also 7
directed that the 3M Company do a pilot survey with their own 8
teams aimed at this particular area of their usage in order to 9
get an identification of any leakage that may involve products 10 dealing with these areas.
11 At the same time, we notified the agreement states of 12 facilities in those agreement states which had a record, a past 13 record of having failed devices, at least by 3M.
14 When it appeared to start dealing with these food and 15 beverage products, we promptly notified the FDA of the new 16 developments in this particular case.
We had notified them, I 17 believe, of the order that we issued initially, but at that 18 time we had no specific concerns with the product being in human consumption.
19 20 We certainly increased our coordination then with the 21 FDA, with the focus on those applications, where human 22 consumption was involved.
We have again developed this list l
23 with the products that we talked about earlier being ones in 24 which both NRC and the FDA have taken samples of those products 25 to have them analyzed at our particular labs.
33 1
Some of the facilities that were involved in the
.s 2
beverage industry were identified by the industry themselves in 3
response to the notice they had received.
They initiated 4
fairly extensive sampling, hiring consultants at their own 5
facilities and have identified areas where the device could 6
enter into the food process.
In those cases, they have also 7
joined in the sampling of their own products in a significant 8
way over the weekend, leaving no efforts unturned to"complete 9
analysis of these types of devices.
10 DR. YOUNG:
Mr. Chairman, I could add that in our 11 studies, in answer to Commissioner Roberts' question, there 12 were a few plants that we found that we got the probate plant 13 that had devices that were not on the 3-M list, so I think the
)
14 strategy that NRC and we are following is to take any company i
15 that has a single device and then ask for that company to give 16 us a full range of plants that that device might be located in, 17 and that will help us enlarge that net.
i 18 The only difficulty will be, of course, that we'll i
j have to rely on the notice that you put out promptly to try and 19 l
l 20 alert other plants to let us know in the event that it's not on i
l the 3-M list at all, which is the danger of your question.
21 22 CHAIRMAN ZSCH:
Well, let me ask a related question, l
23 if I may.
We've focused on devices used in consumer products i
24 as a first priority, and I think that's certainly appropriate -
s 25
- food, beverage, pharmaceutical products.
s 34 1
What's your sense of the likelihood that devices used~
gs 2
at facilities that are not already covered by the orders that 3
we've put out would pose a public health hazard?
4 MR. STELLO:
That's very hard to estimate at this 5
point.
I think by having the order out and the identification, 6
the self-identification, as well as a list, we'll be relying on 7
the kinds of information that we've already had.
Through the 8
identification of plants through your Commission, most of the 9
indications to date are just as Hugh mentioned, that the 10 particles appear to be primarily on the floor and other l
11 surfaces.
Thus again, you're dealing with worker safety, and i
12 that's a high priority, and I believa that's what the 13 Commission is working on now.
14 CHAIRMAN ZECH:
Well, I guess my only concern is that l
15 we should look at the possibility of expanding the order to 16 include other facilities that might use this device, unless we 17 are absolutely certain that we've covered all the aspects that 18 it might get into the human body.
19 DR. YOUNG:
It's hard to answer your question 20 directly because we're just going over the notes of the 21 locations now.
22 CHAIRMAN ZECH:
No, I understand that.
23 DR. YOUNG:
But as a public health significance, I 24 think we're really dividing it into two major categories, those 25 of the workers in the plant --
35 1
CHAIRMAN ZECH:
Right.
2 DR. YOUNG:
And then any consumer product.
3 CHAIRMAN ZECH:
Right.
4 DR. YOUNG:
And we would take the packaging also to 5
be considered as a consumer product.
6 CHAIRMAN ZECH:
Certainly.
7 DR. YOUNG:
And that would include the foil, the 8
boxes, and all of those other areas that could come into 9
contact with human beings.
10 CHAIRMAN ZECH:
Yes.
And it would be expanded as 11 appropriate.
I think that's what you're telling me, isn't it?
12 DR. YOUNG:
That's correct.
And we would focus on i
13 the boxes in the initial phase and anything including the 14 material that's delivered to the consumer, its packaging, its 15 labeling, anything that could possibly be contaminated.
16 MR. STELLO:
Mr. Chairman, let me -- we're meeting 17 with 3-M Thursday, I believe it is, of this week.
18 MR. THOMPSON:
Thursday of this week; yes, sir.
19 MR. STELLO:
And we intend to develop a program, and 20 we will have that ordering of priorities.
We've already dealt 21 with the issue of products which can either be consumed by or 22 applied to humans.
i 23 We're going to look at the list of any other products 24 that could be made, that could otherwica be contaminated in any s
25 way, shape, or form, and we'll be focusing on those, and then I
o 36
. e have, of course, industrial applications, and we want to 1
w 7
2 progress down them to make sure that we get those that have the 3
potential for public harm, to get the highest priority, and, of 4
course, we're very concerned that we pay attention to where 5
there's a potential for worker safety, too.
6 There's also another dimension of the problem.
Other 7
devices that are manufactured by 3-M appear to be more benign; 8
that is, the ones that are involved here, as you ca'n see, have 4
9 compressed air forced through the devices.
There are other 10 devices they make which just take and process ambient air, 11 others which are used in rollers or what have you in printing 12 presses, and we'll be going down the list considering both the 13 likelihood of a problem with the device, as well as the l
14 potential impact on the public health and safety, and we hope 15 to have at least some scope of how to proceed with the rest of 16 them following our meeting on Thursday.
17 CHAIRMAN ZECH:
Vell, I certainly agree with the 18 priorities that you're taking.
There's no question about that, i
19 But I guess my only concern is to make sure that we're looking 20 at the possible threat to the human body from facilitien that 21 we have not so far covered in our order.
22 MR. STELLO:
We will.
We will.
23 CHAIRMAN ZECH:
And that's what I just want to make 24 sure we continue to look at that.
25 DR. YOUNG:
It's an important point.
l
37 1
CHAIRMAN ZECH:
Yes.
And I think that we should be 2
mindful that it may well be necessary to issue an expanded 3
order, and so I would ask you, Dr. Young, your people, to not 4
hesitate to let us know if you think that order should be 5
expanded beyond the one that we have out already 6
DR. YOUNG:
Excellent.
7 CHAIRMAN ZECH:
i think we should do it as soon as 8
possible and give that some kind of a priority.
9 All right.
Thank you.
Mr. Thcmpson, you may 10 proceed.
11 MR. THOMPSON:
Yes, sir.
12 (Slide.)
13 The next slide shows you kind of a summary listing of 14 the types and locations that we have failed devices.
You can 15 see it covers the beverage bottling type industry, some in the 16 food industry, some in the cosmetic and medical products, and I
17 some in, obviously, industrial applications.
18 Now that's a total of 30 places where we have had I
19 reports of some failures of the devices.
The list we have, I l
20 guess, identified with specific facilities, which if I could
(
21 have the specific facilities up --
22 (Slide.)
23
-- identifies only 23 at this time, because there are 24 some calculation levels that deal with the other numbers that 25 are not at NRC's reportable level.
38 1
Do we have copies in your package?
2 CHAIRMAN ZECH:
No.
We don't have a copy of that 3
one.
4 DR. YOUNG:
Mr. Chairman,,as I mentioned, of those 23 5
that are shown, 13 ar FDA-related and regulated plants.
We 6
have had seven plant inspections this time as of 10:00 o' clock 7
this morning.
Of those inspections, we have collected 32 8
samples.
'Of those 32 samples, ten have been completely 9
analyzed, and in none of the samples has there been any 10 radioactivity detected at this time.
11 CHAIRMAN ZECH:
None of the samples of any of the 12 companies on this list?
13 DR. YOUNG:
On this list.
And we're still in the 14 process of assaying these.
These are difficult assays 15 depending on the product.
In liquid, it's a lot easier than it 16 is in dealing with powders.
But we will complete these as 17 rapidly as we can.
And when I talk about a sample, that's 18 really a lot of material; it's not just an individual 19 container.
20 CHAIRMAN ZECH:
We need copies of this list 21 available, please.
Sam, will you make sure that takes place?
22 MR. CHILK:
I'll do it right now, sir.
23 CHAIRMAN ZECH:
Thank you.
24 DR. YOUNG:
And, Mr. Chairman, as any additional 25 plants are identified, our promise to the Nuclear Regulatory
I 39 gs Commission is that we will use our inspectors and our sampling j
1 2
and continue to work in collaboration and work together on 3
these samples.
4 CHAIRMAN ZECH:
Let me be sure now that I understand 5
what you've told me, and I just want to repeat it.
6 DR. YOUNG:
Surely.
7 CHATRMAN ZECH:
On tais list that you've given us 8
with the sites with failed devices, you have told us that your 9
inspections to date -- of how many of them?
10 DR. YOUNG:
We have inspected seven of those, and I 11 can, if you'd like, make an additional copy.
I have on my 12 sheet, we have put the.ones that we have known to be FDA 13 establishments, and where we have inspected is listed company 14 by company, and I can -- if you can get a copy for that --
15 CHAIRMAN ZECH:
I think that would be helpful, too.
16 DR. YOUNG:
Of those seven that we have looked at, we 17 have also taken a total of 32 samples, and a sample in this 18 case is a large number of individual bottles or whatever the 19 product is.
Of those 32, we have completed ten, and there is e
20 no sample that has been radioactive at this time.
21 CliAIRKAH ZECH:
Okay.
You have not found any 22 radioactivity on the samples.
23 DR. YOUNG:
That's correct.
24 CHAIRMAN ZECH:
That you've taken.so far on this 25 list.
40 1
DR. YOUNG:
That's correct.
Nor has the Nuclear f ~s 2
Regulatory Commission nor has the manufacturing plant 3
personnel.
So that of those that have been examined so far, we 4
have found no radioactivity.
5 CHAIRMAN ZECH:
And no radioactivity as far as the 6
product is concerned?
7 DR. YOUNG:
As far as the product is concerned.
8 CHAIRMAN ZECH:
That's what you're talking about.
9 DR. YOUNG:
That's right.
I'm totally, in all of my 10 remaras, I'm talking about the consumer product.
In some of 11 these plantr, there have been found to be radioactivity, as was 12 described earlier.
13 CHAIRMAN ZECil At the facility, though.
Some of 14 these plants -- or is it all of these plants that have found --
15 MR. STELLO:
All.
16 CHAIRMAN ZECH:
All of them have contamination at the 17 facility?
l 18 MR. STELLO:
Contamination at the facility.
So far 19 none of the products, consumer products, at these facilities 20 have tested positive.
21 CH.\\IRMAN ZECH:
All right, fine.
22 MR. STELLO:
By eith9r FDA, NRC, or the company 23 themselves.
The company programs in many cases have been very 24 extensive.
25 DR. YOUNG:
That's correct.
L----________________
Y 41 1
CHAIRMAN ZECII:
Now are we looking at other sites e
2 that have failed devices?
Do we know that thls is a complete 3
list?
4 MR. THOMPSON:
This is not avcomplete list.
From the 5
extent that as additional information ic'ecming in, you know!
6 and inspections are ongoing now, I think there may be two or 7
three additional facilities that would be added to the list.
8 This was prepared earlier this morning.;
9 So the list, as we continue our inspection 10 activities, the list will continue to grow.
11 I would note that,. I think, as we said-in all of 12 these casos, in particu)ar with respect to the beverage 13 industry, there havo been extensive samplings in all of the 14 beverage cases for whjeb NRC has regulatory oversight for, and 15 the products have,~in fact, beep found not to contain -- not to 16 be contaminated with any of these --
17 CRAIRMAN ZECH:
Have all the facilities that NRC hss' 18 interfaced with in thia"intter and FDA, have all the facilitles l
l 19 and companies been cooperative as regards this effort?
20 MR. THOMPSON:
They have been. absolutely cooperative.
l 21 They're obvio1 sly all concerned about their names being named.
22 CHAIRMAN ZECH:
Yes, I'5 sure they are.
But none of 23 them have been uncooparative; is that wnat'you're telling us?
l 24 DR. YOUNG:
Not-to the best o% my knowledge, and also 25 it is important to point out that' manufacturing has ceased in
42 1
these plants, so that there's not anything further that's being 2
introduced.
~3 I think the good news, Mr. Chairman, is that though 4
the samples are limited to date and still ongoing, that no 5
plant yet that had contamination that was evident upon 6
inspection by the Nuclear Regulatory Commission, had any 7
radioactivity in the consumer products that were manufactured 8
there, and that's what we have to keep focusing on.
9 CHAIRMAN ZECH:
I understand.
We're also thinking 10 about the workers, too, now.
11 DR. YOUNG:
Absolutely.
12 CHAIRMAN ZECH:
And if th..re's contamination at the 13 plant, I presume we have procedures underway to not only 14 decontaminate the facility, but to check the workers for any 15 contamination that they may have received.
16 MR. STELLO:
That's correct.
17 CHAIRMAN ZECH:
Those things are going on also; is 18 that correct?
19 MR. THOMPSON:
We are following up with each of the 20 facilities Nith respect to the actions they are taking to 21 ensure that their employees, within our regulatory area -- the 22 agreement states are following up on other ones -- to ensure i
23 that the workers are properly evaluated as part of this 24 program.
25 CHAIRMAN ZECH:
All right.
Proceed.
i o
43
)
1 MR. STELLO:
While we have the list in front of us, J
2 let's recall that this activity -- and I should congratulate 3
the Staff; they've been working pretty much throughout the 4
entire weekend, and I'm sure when we get back to our offices, 5
as we continue, we'll get new information, and this list could 6
very well change today, tomorrow, next week.
We are not 7
through.
8 CHAIRMAN ZECH:
I understand the list is not 9
necessarily a complete list.
I hope it's accurate as far as 10 you've put it together.
31 MR. STELLO:
It is as accurate as we could make it at 12 the time we walked into this meeting, which is probably why it 13 wasn't included in the packages.
14 CHAIRMAN ZECH:
All right, fine.
15 MR. THOMPSON:
We are confident that the facilities 16 on this list, in fact, did meet our reporting level for the 17 contamination of the 11,000 disintegrations per minute 18 reporting aspect.
19 CHAIRMAN ZECH:
All these facilities have stopped 20 using these devices; is that correct?
21 MR. THOMPSON:
To the best of my knowledge, all of 22 these faci.' ties have not only stopped their process line but 23 they have removed these devices and in most cases they have 24 completed the decontamination activities necessary to allow 25 them uo continue processing.
44 1
CHAIRMAN ZECH:
The Food and Drug Administration is f3 2
again sampling the products from these companies.
3 DR. YOUNG:
That's correct.
4 CHAIRMAN ZECH:
You have sampled some but not all at 5
this point and you are continuing to sample the others, I 6
presume.
7 DR. YOUNG:
That's correct.
We are not allowing any 8
additional lot 5 to go into commerce until we know whether the 9
lots can be traced of those particular plants.
That is a very 10 important issue for assuring consumer safety.
We are working 11 on that as well right now.
12 CHAIRMAN ZECH:
Thank you.
You may proceed.
13 MR. DAVIS:
This is Bert Davis with Region III.
We 14 do have one company that had some contamination and cleaned it 15 up, removed the device that was leaking but they had some other 16 devices that were used in critical applications.
They wipe 17 tested those and found they were not leaking and they are using 18 them today.
19 DR. YOUNG:
Are they manufacturing food, drug and 20 cosmetic products?
{
21 MR. DAVIS:
No; they are not.
22 DR. YOUNG:
The concern I would have and would just 23 caution you on is that wherever one is putting something into 24 the consumer line, one has to be sure you can tell whether the I
l 25 lot is clearly marked on the box and on the shipping areas.
I l
45 1
know'we have been working very closely with the Nuclear 77,
2 Regulatory Commission and we shall continue to, to be sure that 3
the consumer products when introduced can be tracked.
4 CHAIRMAN ZECH:
Fine.
5 MR. THOMPSON:
I think that points to some of the 6
difficulty we may be facing in the futura, that some of these 7
static eliminator devices do have a safety implication with 8
respect to potential fire hazards, with respect to the quality 9
of a heart pacemaker device.
We will have some difficult 10 judgments to make with respect to whether those devices are to 11 be automatically removed or whether it is a show cause type of 12 approach.
13 CHAIRMAN ZECH:
I think the Commission should be 14 involved in those decisions.
Iappreciadethefactthatwe 15 might have some tough ones.
This is a very important issue.
16 Public health and safety is concerned.
On those calls that you 17 think you have good reason to allow the continued use of this 18 device, I think you should involve the Commission.
19 MR. THOMPSON:
We certainly will.
20 MR. STELLO:
Mr. Chairman, you recognize that if we 21 find issues out there where we have to take immediate action, 1
22
.the Commission has authorized the staff to do so.
(
23 CHAIRMAN ZECH:
We are not reneging on anything we 24 have already authorized you to do.
25 MR. PARLER:
It was a question of perhaps putting l
(
46 1
various things in a balance, immediate action would not be p
2 taken for some reason.
If you get to that point, the 3
Commission and the Chairman wants to know about it.
4 CHAIRMAN ZECH:
Yes.
Thank you.
That is exactly 5
right.
6 MR. THOMPSON:
In fact, we probably are taking some 7
additional actions very soon with respect to making sure that 8
3M notifies all of its customers of the activities that we are 9
having and addressing now, to the extent that we have some 10 concerns that they have not fully notified all of their 11 customers of the problems.
12 CHAIRMAN ZECH:
What I am saying is I expect the 13 Commission to be completely informed.
14 MR. STELLO:
Absolutely.
15 CHAIRMAN ZECH:
Come to us if you do feel there is 16 something that is to the point where your judgment has any 17 concerns at all.
18 Go ahead, Mr. Thompson.
19
[ SLIDE.]
20 MR. THOMPSON:
Late last week, we issued a second 21 order.
I think it was referred to earlier today.
It was 22 immediately effective, confirting the 3M Company's decision to 23 remove these devices, the 902, 906 and 908 series, from any 24 application dealing with food, bottling, pharmaceutical and 25 cosmetic uses.
We felt this was the appropriate step to be
4 D
47 1
taken given the. extensive nature of these failures in these 2
devices.
3 The 3M Company did not disagree with that.
In fact, 4
it started removing these types of devices prior to doing that.
5 We are also, as we talked about earlier, continuing 6
actively our program of sampling the products, where we find 7
the contaminated facility.
We have an important meeting with 8
3M this week.
In fact, today'at close of business, they should 9
have the report of their results of the surveys they have been 10 doing, at the higher risk facilities and developing an action 11 plan which 3M proposes to take during the coming timeframe to 12 get a complete understanding of the problems occurring.
13 Our current actions, as we talked about earlier, is 14 the high priority sampling of the human products.
3M's report 15 to us, which is due today, and we also have ongoing right now a 16 review by Region III of the records of 3M of other static l
17 eliminator devices.
These are the other ones and the ones l
18 currently in question, to see if the history of these devices l
19 that is available at 3M and their records indicate there may be 20 a pattern that we were not aware of for those devices, as we 21 were not aware of for the 900 series devices.
22 We do have our order with 3M and NRC and I would note 23 FDA is joining us in Chicago at the meeting on Thursday to 24 receive and evaluate the response that 3M has had to the order.
25 We will basically take any further actions as we need in l
l l
48 1
coordination with the Commission, where we don't need to take f..
2 immediate action, if we find the need to take immediate action, 3
we obviously will take immediate action in order to protect the 4
public health and safety.
5 Two other actions that we are following up on is some 6
evidence at 3M of incomplete reporting of leaking surveillance 7
of these devices to us.
We would have believed the leaking 8
devices, the 70 some odd cases that we had identified in our 9
inspections, there should have been some better understanding 10 of the reporting of these devices to us so this would not have 11 occurred.
12 Also, an evaluation of 3M's assessment of how these 13 devices are being utilized in the environment, when they allow 14 these to be operated under their general license provisions.
15 (SLIDE.]
16 MR. THOMPSON:
Finally, covering some of the issues 17 that we see, we really need to complete our root cause 18 determination, was it extraordinary ambient conditions, were 19 these devices just too vulnerable for ordinary conditions to be l
20 continued.
Should we expand our testing and suspension to 21 other models.
Are other product samplings needed, if so, which 22 ones.
How to evaluate the competing risk.
Also, depending on 23 the number, determine that the facilities that had leaking 1
24 devices are adequately evaluated and decontaminated, the 25 appropriate way to do that, make sure if it involves thousand l
l
d i
49 1
and thousands of facilities, our resources will be stretched, g~s 2
but certainly we will want to make sure we have some confidence 3
that the places that become contaminated are certainly cleaned 4
up before the activity is resumed.
5 MR. STELLO:
That concludes our presentation.
6 CHAIRMAN ZECH:
You have given us your current risk 7
evaluation before and I presume that is why you skipped it, you 8
don't have any problem with it.
I presume FDA has said the 9
same thing.
10 MR. THOMPSON:
Essentially, Mr. Chairman, we 11 anticipate there will be a continued identification of some 12 contaminated facilities as we continue the inspection 13 activities.
As we said earlier, it is unlikely even if some of 14 those microspheres were to enter into the consumer products, it 15 is unlikely it would be a significant health hazard to the 16 public.
Nevertheless, we are continuing jointly with FDA and 17 NRC and the agreement states to sample these products as we go 18 through the next weeks.
19 CHAIRMAN ZECH:
All right.
Thank you very much.
20 Questions?
Commissioner Roberts?
21 COMMISSIONER ROBERTS: No questions, Mr. Chairman.
1 l
22 MR. DAVIS:
Mr. Chairman, we do have some information l
23 regarding Commissioner Bernthal's question on the purity of the l
24 polonium, if you would like to record it.
l 25 CHAIRMAN ZECH:
He is not here but go ahead.
We will
o a
50 1
tell him about it. '
2 MR. DAVIS:
Bruce Mallett, the Branch Chief in our 3
office, is going to do that.
4 MR. MALLETT:
This is Bruce Mallett.
Thank you for 5
letting me address this issue.
This is polonium 210 and it is 6
made by neutron irradiation of stable bismuth and it is 7
irradiated by Atomic Energy of Canada in their irradiator of 8
aluminum cans.
Polonium 210 is then extracted by a melting 9
chemical extraction process at a very high temperature process 10 through a precipitated filter and it is electroplated on the 11 platinum gauges.
They call it a gauge, but it is actually like 12 a wire.
The stable bismuth used to irradiate is nuclear. grade 13 so the purity is in the parts per billion range.
After the l
14 polonium has been precipitated and plated on the platinum l
1 15 gauges, prior to incorporating it in microspheres, they do a 16 gamma spectroscopy of it.
If there is anything else that shows 17 up besides polonium 210, they reject the batch.
18 MR. STELLO:
Thank you.
19 CHAIRMAN ZECH:
Thank you very much.
20 Let me just ask a couple of questions.
With regard 21 to our licensing process itself and the monitoring process, it 22 seems to me that if we issued this license in 1964, that is 24 l
23 years ago, how often have we reviewed that license itself or 24 that p.rocess itself to make sure that we -- somewhere along the l
25 line I have been told that 3M has these devices returned every
o e
51 1
three months -- every 13 months; is that correct?
,.s 2
MR. THOMPSON:
Yes.
The normal practice for this 3
particular device is that it must be, with respect to our 4
current license, leak tested every 12 months.
There is an one 5
month grace period, which is the current practice for the 6
general licensee to return it back to 3M for leak testing.
7 The general licensees normally don't get involved in 8
making contamination surveys, leak testing of this device.
9 They rely almost entirely on 3M's service in the contractual 10 way that currently exists.
11 CHAIRMAN ZECH:
When they return the device to 3M, 12 does 3M monitor it for contamination or radiation leakage?
13 MR. THOMPSON:
They do.
Let me ack Region III to l
14 respond precisely to what they do, since they just did the l
l l
15 inspection.
16 MR. SRENIAWSKI:
Gauges are leased for a year.
All l
17 the gauges are almost exclusively returned to 3M.
The general l
l 18 licensee does not do the leak test.
The leak tests are l
19 scheduled for 13 months.
Your statements are essentially true.
20 It is rare that a licensee would hire a private consultant to l
l 21 do an individual su'vey and it would only be in the case of an r
22 accident.
There have been a few accidents and there have been 23 a few cases where 3M or a private consultant has responded, a 24 serious accident like a gauge dropping into a furncce.
25 MR. PARLER:
The accident that he is talking about I l
1
52 1-gather is something that happened in the industrial process 2
that possibly could have caused damage to the gauge, to the 3
device, not an accident that could release stuff.
4 MR. SRENIAWSKI:
There have been a few fires which 5
fall into that same category, where the entire building goes.
6 MR. THOMPSON:
I believe in answer to your question, 7
Mr. Chairman, what normally occurs is that there is a test done 8
of the device by 3M when it is received at the end of the 9
lease.
They do a drop test and a smear test on the device to 10
.,ee if it had leaking, if the device had been leaking.
11 CHAIRMAN ZECH:
How long have we known this leakage 12 has gone on and the contamination problem?
Has 3M known it for 13 a long time or did they just discover it?
ThisisBertDavisInRegionIII.
Let me 14 MR. DAVIS:
15 try to answer that.
We get a monthly report from 3M, that 16 shows failure rates of devices.
That has been running at about 17 0.03 percent failure.
That failure rate is consistent with 18 what is expected as the failure rate at the time the devices 19 were originally licensed.
20 One of the problems we found in our inspections was 21 that we determined that there were some devices, for example, 22 the 900 series that we have been talking about, that had a 23 higher failure rate than the.03 percent, around 1 percent, and 24 that was not being reported to us in the monthly report.
s.
25 Apparently the reason was that whenever 3M would
53 1
examine the products, when they were returned to the.3M 2
facility, if they determined that the leakage was due to an 3
event, as they called it, which would be damage or a fire or 4
even oil contamination, they would call that a failure due to 1
5 an event and they were not reporting that to us.
6 We learned of these things last week.
7 CHAIRMAN ZECH:
What you are saying is they had 8
reported a very small number of problems; is that correct?
9 MR. DAVIS:
That is right.
Over the years, they 10 reported a small number of problems and we did not consider 11 those problems.
The reason I have given is it was because the 12 number of problems was consistent with what the expectations 13 were when the devices were licensed.
14 CHAIRMAN ZECH:
Has there been any change to the 15 device itself in the years since we have licensed it?
For 16 example, how about the adhesive material itself?
Has that been 17 changed?
If that has been changed, would that have to come to 18 us to review?
19 MR. DAVIS:
We would have to review it.
Let me ask 20 if my staff knows.
Mr. Sreniawski reports that there was at 21 least one change in the adhesives used during this time 22 interval.
23 CHAIRMAN ZECH:
Did we review that and approve it?
24 MR. THOMPSON:
The license was renewed, I believe the 25 last one was in 1985.
Certainly our last renewal did address
54 1
.that.
7 2
Don, was that change made before the 1985 timeframe?
3 MR. SRENIAWSKI:
Yes; it was.
4 MR. THOMPSON:
I guess the question is, Mr. Chairman, 5
whether or not the staff looked at the epoxy change as part of 6
our licensing process.
7 MR. SRENIAWSKI:
We don't know the answer to that.
8 MR. STELLO:
We will get the answer back to you, Mr.
9 Chairman.
10 CHAIRMAN ZECH:
Fine.
In 1985, what happened?
Did 11 you say we reviewed the whole license in 1985?
12 MR. THOMPSON:
Typically with the material licensees, 13 we review their license every five years and at one time -- we 14 have a provision which is called timely renewal.
If a licensee 15 has requested a renewal of his license and has an application 16 submitted to NRC for review and approval, prior to the 17 expiration date, it will remain effective in a status called 18 timely renewal.
19 This particular license application had undergone a l
20 number of renewals.
It did have, as I mentioned earlier, that t
21 one period where there was staff concern over this particular 22 license and it went for a fairly long period of time without l
23 actually being renewed but remained under the timely renewal 24 status.
25 CHAIRMAN ZECH:
Fine.
Could you review for me very
55 1
briefly again the status of recalling the devices?
What have s
2 we done as far as limiting their use?
3 MR. THOMPSON:
The first thing we have done has 4
stopped any distribution of these devices to any application 5
from 3M, of the 902, the 906 and the 908 series, static 6
eliminators.
These particular ones are used in the high 7
pressure air systems.
That involves the entire spectrum of 8
applications of those devices in the industry.
9 We have also issued a confirmatory order confirming 10 the removal of those devices that are specifically in the food, 11 beverage, pharmaceutical and cosmetic industry, to the extent 12 they have been identified.
Those devices are to be removed 13 immediately from the application in the plant, packaged and 14 await further shipping instructions from the 3M Company, which 15 would normally have those devices returned back to 3M since 16 they are leased devices.
17 COMMISSIONER ROBERTS:
I have a question that you may i
18 not be able to answer.
If I am manufacturer X and I have one 19 of these devices and I must cease using it, are there 20 alternatives for whatever the industrial process is?
21 MR. THOMPSON:
Commissioner, I believe the answer is 22 yes.
In discussing it with a number of the manufacturing 23 applicants, I have found certain individuals who had these 24 devices, who thought they were installed and had not been 25 installed, they were sitting in the warehouse.
There are those
i 56 1
who have removed t. hem 1.mmediately and the' plant is able to 2
operate.
3 I am not aware of any specific device in the 4
discussions with the group we talked to that would not be able 5
to continue operating.
6 The one concern I am aware of dealt with the 7
pacemakers, the order, I do not believe, covered the medical 8
devices at that time, because of the lack of specific knowledge 9
of where we would actually shut down an industry that made some 10 medical davices.
11 We did not address other areas such as the static bar 12 eliminators.
They are not covered by this order.
They may 13 have some concerns with respect to fire hazards at the printing 14 presses.
They are thousands of applications of these devices.
15 Commissioner, I cannot tell you that everybody will 16 be able to continue to operate every part of their facility as 17 designed without a replacement.
I do understand there are non-18 radioactive static eliminators available.
Whether they would 19 fit immediately in the process, I don't know.
20 CHAIRMAN ZECH:
Well, I'd like to thank the Staff and 21 the Office of Nuclear Materials Safety and Safeguards in 22 particular for this presentation.
23 I would also like to thank Dr. Frank Young and his 24 colleagues from the Food and Drug Administration for joining us 25 here today.
We value your knowledge and expertise in this
'57 1
. area, and we certainly respect your responsibilities, as well 2
as our own.
We appreciate your continuing cooperation with us 3
in this effort.
4 It looks to me like we are taking.the proper steps, 5
but I think we need to continue to take an energetic, yet 6
conservative and cautious approach to the actions that we have 7
talked about here today, but also to act proisptly when any 8
action seems called for, and I would like to encourage the 9
Staff to continue working with the Food and Drug 10 Administration, with the states involved, and with the other 11 appropriate agencies of our government, as well as with the 12 industries and the companies involved, too.
13 The Commission intends to closely monitor all these 14 activities, and we want to make sure that we are fully 15 informed.
16 MR. STELLO:
You will be.
17 CHAIRMAN ZECH:
Thank you very much.
We stand 18 adjourned.
19 (Whereupon, at 3:07 o' clock, p.m., the Commission 20 meeting was adjourned.)
21 22 23 24 s
25
1 i
2-REPORTER'S CERTIFICATE 3
4 This is to certify that the attached events of a 5
meeting of the U.S. Nuclear Regulatory Commission entitled:
6 7
TITLE OF MEETING: Briefing on Statis Elimination Device Problems 8
PLACE OF MEETING:
Washington, D.C.
9 DATE OF MEETING: Monday, February 8, 1988 10 11 were held as herein appears, and that this is the original 12 transcript thereof for the file of the Commission taken
{'
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 18 Suzanne B.
oung 19 20 l
21 22 Ann Riley & Associates, Ltd.
23 24 25
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INITIAL EVENTS: ASRAi0 OEMICAL COPPANY (ACC)
ACC CUSTOPER QlESTICED SMALL AIRR ACTIVITY IN SLIRRIC ACID JANUARY 21 INVESTIGATION SHOED AIRR CONTAMINATION IN PLANT AIO ON 10RKER CLOTHING NRC NOTIFIED-DISPATOED TEAM TO ACC SITE (JAN 22to)
NRC TEAM RXH) 00NTAMI!MTION AT ACC - EASTON, STATE OF TEXAS F0iND IT AT ACC-DALIAS (JAN 214m)
PRC ISSLED ORDER SUSPEdulNG DISTRIBUTION OF DEVICES (JAN 25m)
N) OTER ACC PLANTS SHOED NO CONTAMINATION 4
INITIAL FIl0lNGS Af0 ALTIONS 00NTAMINANT IS COMING LDOSE BUT APPEARS NOT TO E DISSOLVING
- SAffLING OF ACC PRODUCTS
- SAffLING OF M)RKERS' LEIE
- ACC PRODUCTS EE ELD LNTIL SION TO E ACCEPTABLE R)R INDUSTRIAL USE i
- EGION III TEAM TO 3M - JAN 25m
- 1sT NRC ORDER TO 3M - JAN 25m
(
- NOTIFY ALL CUST0ERS
- SUSPEND DISTRIBilTION 1
- SURVEY APO ETERMIE SCOPE APO SOLUTION
- ANALY2E ACC DEVI&S FOR FAILIFE ECHANISM
- PROVIE LIST OF CUST0ER TO NRC
CIRRENT SAFETY CONCUJSION
- 00NTIIED IDENTIFICATION OF CONTAMINATED FACILITIES LIKELY AFFECTED
- BASED ON TE nmLYSES AVAILABLE AT 1111S TIE, EWN IF MICROSPERES GAIED ACCESS TO 00NSIER PRODUCTS, IT IS LN_IKELY TilAT TEE WXLD E A SIGNIFICANT EALTH HAZARD TO llE PLELIC. EVERIELESS, IN ORDER 10 PORE FULLY EVALIRTE TE POTENTIAL SAFELY SIGNIFICANCE, SNPLES OF CONSINR PRODUCTS RESULTING FROM TESE MMFACRRING PROCESSES ARE EING ANALY2ED BY IRC AND FIA.
1 h
d R)LLDEP ACTIVITIES i
DISCOVERY OF PSNY PORE DEVIE FAILLEES, SOE IN FOOD, IDERAGE l
Ati) PHARMEEUTICAL IP0USTRY INCREASED COORDINATION WITH FIR AND STATES WITH FOCUS ON lif%N APPLICATIONS 5
- 1sT PRIORITY R)R lifmN APPLICATIONS WERE FAlllEES HAVE BEEN i
PREVIOUSLY IDENTIFIED IN DEVI&S REREED TO 3M
- 2m PRIORITY R)R lif9N APPLICATIONS WITH ND l@0WI DEVIE FAILLES I
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TYPES OF LOCATIONS WITH FAILED DEVICES BEVERAGE BOTTLING 12 l
FOOD 5
COSMETIC, MEDICAL PRODUCTS 2
INDUSTRIAL 11 TOTAL 30 i
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NRC 2ND ORDER 1
0 FEBRUARY S C0fflhMATORY ORDER. IMMEDIATELY EFFECTIVE I
. CONFIRMED 3M F,EBRUAR ~ 3 AND FEBR.UART S NOTIES' T0 t,
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' REMOVE DEVICES FROM FOOD, BOTTLING, PHARMACEUTICAL, i
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AND'CDSMETIC USES bl.Y.iic O
SAMPLING PROGRAM WITil NRC, FDA AND STATES COLLABMATING c
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3M REPORTS AND ACTION PLAN MEETING NEEKiOF FEBRUARY 8 3. g.
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o OMENT RISK EVALLRTION BASED ON TIE ANALYSES AVAILABLE AT THIS TIE, EVEN IF MICROSRBES CAIED ACCESS TO 00NSlFER Pf000 CTS, IT IS lM lELY TIMT TEE WDLLD BE A SIGNIFICANT EALTH IMZARD TO TE PlELIC. EVERTIELESS, IN ORDER 10 P0RE RA1Y EVAIJJATE TIE POTENTIAL SARTY SIGNIFICANCE, SAPPLES OF CONSLER PRODUCTS ESlLTING FIO1 TIESE MAfAFACIMING PIOCESSES ARE EING ANALY2ED BY fEC Af0 FDA.
a.
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ISSES ROOT CAUSE ETERMINATION
- ARE TESE EVIES FAILLES CAUSED BY EXTRAORDINARY APBIENT CONDITIONS OR ARE TE DEVICES T00 VlAKRABLE TO ORDINARY 00f0ITIONS?
- SHOULD TEST AND SUSPENSION E EXID0ED TO OTER f0DELS SUCH.AS STATIC BARS?
- ARE RRTER PRODUCT SMMES NEEDED? WICH7 SHOULD 00FFETING RISKS E ETERMlED?
DEPENDING ON RfEER, DETERMIE THAT FACILITIES HAD LEAKY DEVICES ARE ADt'DUATELY EVALUATED 9
O I
s CORRECIED COPY LIST OF SITES WITH FAILED DEVICES
- TYPE OF COMPANY LOCATION PR000CT WHEN
'I.
Kil Carrollton, TX chemicals 2/4/88 2.
KII Sunnyvale, CA chemicals 3.
Xicor Milpitas, CA chemicals 4.
Coca Cola Dallas, TX beverage 5.
Coca Cola Dallas, TX beverage 6.
Coca Cola Fort Worth, TX beverage 7.
Coca Cola Needham, MA beverage 8.
Anheuser Busch St. Louis, MO beverage
- 9. Custom Photo Austin, TX
- 10. Ashland Chemical Easton, PA chemicals
- 11. Ashland Chemical Dallas, TX chemicals
- 12. McDonnell Douglas St. Louis, MO
- 13. Block Drugs Dayton, NJ denture 2/S/88 adhesive
- 14. Ford Motor Co.
Milan, MI
- 15. Anheuser Busch Jacksonville,.FL beverage
- 16. Avon Morton Grove, It cosmetics
- 17. Ross Labs Div.
Casa Grande, AZ food, similac of Abbott Labs.
- 18. Coca Cola Phoenix, AZ beverage
- 19. Paul Flv ideas St. Louis, MO
- 20. Best Fooc Unit Argo, IL
- 21. 3M Ames, IA I
- 22. Pepsi Cola Tulsa, OK beverage
- 23. Coca Cola San Liandro, CA beverage "Contamination at these facilities exceeded 0.005 uCi -
11,000 DPM
SATURDAY, FEBRUARY 6, 1988:. 9:00 P.M. EST PLANTS THAT EXCEED NRC REPORTING GUIDELINES (23 sites)
NAME LOCATION PRODUCT RESULTS KTI Carrollton, TX Chemical s KTI Sunnyvale, CA Chemical s XICOR M111pitus, CA Chemical s i
Coca Cola Dallast TX Soft Drinks FI Coca Cola Dallas, TX Soft Drinks FI Coca Cola Fort Worth, TX Soft Drinks FI Coca Cola Needham, MA Soft Drinks FI Anhauser-Busch St. Louis, M0 Malt Beverages F
Custom Photo Austin, TX Photo ?
Ashland Chemical Easton, PA Chemical s Ashland Chemical Dallas, TX Chemicals Mcdonald Douglas St. Louis, M0 Airplane ? '
Block Drugs Dayton, NJ Dental Adhesive FI Ford Motor Milan, MI Cars ?
Anhauser-Busch Jacksonville, FL Malt Beverages F
Avon Morton Grove, IL Cosmetics F
Ross Laboratories Casa Grande,.AZ Infant Formula FI Coca Cola Phoenix AZ Soft Drinks FI Paul Flum Ideas St. Louis, MO
?
(2.
- Best Food Unit Argo, IL
? Food F
3M Ames, IA
? Chemicals ?
Pepsi Cola Tulsa, OK Soft Drinks F
Coca Cola San Leandro, CA Soft Drinks F
F = Known to be FDA establishments I = Inspected and sampled as of 9:00 P.M., 2/6/88 l
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ADVANCED COPY TO:
The Public Document Rocm 9
DATE:
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SECY Correspondence & Records Branch h
i Attached are copies of a Commission meeting transcript and related meeting i
document (s). They are being forwarded for entry on the Daily Accession List and
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Meeting
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Meeting Date:
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