ML20133L693
| ML20133L693 | |
| Person / Time | |
|---|---|
| Site: | 07000036 |
| Issue date: | 02/04/1971 |
| From: | Cunningham R US ATOMIC ENERGY COMMISSION (AEC) |
| To: | US ATOMIC ENERGY COMMISSION (AEC) |
| Shared Package | |
| ML20133G976 | List:
|
| References | |
| FOIA-96-343 NUDOCS 9701220109 | |
| Download: ML20133L693 (4) | |
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UNITED STATES ATOMIC ENERGY COMMISSION
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oses February 4, 1971 j
Note to Files VISIT TO MALLINCKRODT, ST. LOUIS, JANUARY 11, 1971 I visited Mallinckrodt Nuclear on January 11 1971, to discuss (a) radio-i i
pharmaceutical quality control procedures, (b) levels of radiation in unrestricted areas from waste storage, and (c) control of iodine release.
Mr. Frank A. Schottelkorb, General Manager, Diagnostic Products Division; Dr. Gordon Lindenblad,'Research and Development; and Mr. Donald W. Solden, Health Physicist, attended the meeting. Mr. Schotte1korb is new with Mallinckrodt. Mallinckrodt Nuclear as well-as other pharmaceutical production 1
operations report to him.
Dr. Werner Wald, who was Manager of Mallinckrodt Nuclear, recently resigned, and the position has not yet been filled.
Mr.
Schottelkorb is supervising the Mallinckrodt Nuclear operation with assistance j
from Dr. Lindenblad until the position is filled.
Quality Control The reason for discussing quality control relates to the incident in September 1970 involving extensive molybdenum breakthrough from a batch of technetium generators manufactured at the Carlstadt facility. These generators were j
E shipped to customers even after quality control detected molybdenum break-through. This raised questions about the adequacy of Mallinckrodt's quality control program. Background and exchanges of correspondence about this 4
incident are contained in the Mallinckrodt files.
(Mano to the Files dated September 8, 1970; letter from Mallinckrodt dated September 14, 1970; letter l
to Mallinckrodt dated October 22, 1970; and letters from Mallinckrodt dated 4
October 27, 1970, and November 13, 1970.)
The issues concerning quality control were not resolved as of the November correspondence in that it appeared that management might make a decision to ship pharmaceutic.a1 products to customers or not recall those that were already shipped even though quality control indicated that the products did not meet specifications. During the course of the discussion, I indicated that, in our opinion, the quality control program should include the following elements:
1.
A range of limits on product specifications for in-house quality control purposes which are well within the regulatory limits. If the in-house limits are exceeded, supervision should be notified inanediately that such is the case.
4 9701220109 970114 PDR FOIA FLOYD96-343 PDR
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February 4, 1971 4
2.
A strict prohibition against shipment of drugs which do not meet regulatory 1
specifications. If drugs which exceed regulatory specifications are dis-tributed prior to completion of quality control tests, they must be recalled.
' 3. -Quality control records of all tests conducted, and routine management review of such records.
4.
A quality control department which is organizationally independent of other departments, such as production or R&D. Quality control reports should be sent to and reviewed by top management independent of these departments.
1 (These four points were developed with the assistance of Capt. Briner, our j
. radiopharmaceutical consultant.)
i Mr. Schottelkorb agreed and said that he would send a letter which corrects some of the objections we had to their letter of November 13 and meets the four objectives. It should be noted that Mr. Schottelkorb began employment with Mallinckrodt after the September incident and has since made a number of changes in quality control.
Levels of Radiation in Unrestricted Areas from Waste Storage i
The Independent Measurements Program conducted by the Division of Compliance found that the levels of radiation in unrestricted areas resulting from the manner in which Mallinckrodt Nuclear operates an outdoor waste storage facility were slightly in excess of the standards in 10 CFR 20.
Mallinckrodt was in-formed of these findings and, because of this, submitted an application dated September 18, 1970, for an exemption from Part 20 to these levels based on occupancy factors for the unrestricted area involved. The application was not acted upon since it was our opinion, based on the information it contained, Il that the levels of radiation would be relatively easy to reduce, and, therefore, the exemption is not justified and, secondly, that the occupancy factor used to justify their application could vary considerably after granting an exemption since it involved workets in an adjacent factory over which Mallinckrodt-had no i
control.
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Af ter touring the plant and examining the waste storage facility, I remain of the opinion that it would not be difficult nor involve substantial capital investment to (a) add further shielding to the storage facility or (b) relocate it in an area well within plant boundaries which would not result in excessive i
levels of radiation in unrestricted areas. Mallinckrodt has upgraded the
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shielding of the present storage facility within the past few months, but they have not yet evaluated how this has affected a reduction of levels of radiation 1
1 in unrestricted areas. The TLD data from the Independent Measurements Program which were available as of the date of my visit were through mid-July 1970.
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February 4, 1971 4
Mallinckrodt is currently undergoing plant expansion with the acquisition of two new'bu11 dings. They have tentative plans to relocate the storage l
facility by the end'of 1971 or early in 1972. It was suggested to Mr.
Schotte1korb that this'was too long a time to wait to resolve the problem if it still existed, and he agreed. I told Mallinckrodt we would furnish what i
TLD data are available since July to assist them in their evaluation of cur-i, rent radiation levels in unrestricted areas. If levels are etill in excess of Part 20, Mr. Schottelkorb said they would propose a plan to solve the problem in a rather short time.
Mr. Schotte1korb said they would let us know 4
by approximately February 15 what the situation is with respect to current levels of radiation in unrestricted areas, their plans to correct the problem if it still exists, and a time schedule for making the corrections.
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i relayed to Solden on February 3 the remaining TLD data for Station No.1.
The data cover the period July 18, 1970, through December 29, 1970.
It appears j
that levels of radiation average roughly 350 mrem per 30 days.
Solden said that, while this might be in compliance with Part 20, it was sufficiently near the limit that something needed to be done.)
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Control of Iodine Release I outlined to Mallinckrodt our program to reassess iodine discharge from major iodine processors to determine whether such discharge was as low as practicable and to determine whether or not additional limits were necessary for iodine in air effluents because of exposures via the grass-cow-milk chain.
l The area in which Mallinckrodt is located appears to have been rural until
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recent times. There are a number of light industries developing, and there are some residences within a thousand-yard radius, mostly old and probably l
of low value which could be scheduled for destruction as land values go up.
The topography is rolling hills with Mallinckrodt situated in a rather shallow basin. A new housing development is located approximately two miles SW of the i
plant. The nearest farm which I was able to locate was approximately three miles WSW of the plant. Although no cows were observed, this may have been due to the bad weather which prevailed at the time. Mallinckrodt agreed to survey the surrounding territory to determine where the nearest dairy cattle are.
On the basis of quantities of iodine handled per week compared to the amount l
of iodine released in air effluents, Mallinckrodt is the least effective of 3
the four major radiopharmaceutical manufacturers in limiting iodine discharge in air effluents. The situation had improved somewhat in 1970.
Solden indicated that the average quantity of iodine received by Mallinckrodt per week was 34 curies, and the 1970 release was 0.9 curie. During a tour of the plant, it was learned that Mallinckrodt has roughly 13 iodine processing stations, some of which involve hoods that do not have charcoal filters.
In
- addition, the main filter station where their large quantities of sodium iodine e-r,,
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o Note to Files 4
February 4, 1971 are processed has a faulty gasket on the charcoal bed allowing a high percentage of effluent bypass.
Mr. Schotte1korb agreed that probably all iodine stations should have charcoal filters, except perhaps for some stations where microcurie quantities of iodine are already incorporated in certain types of finished radiopharmaceuticals (not sodium iodine).
Mr. Schottelkorb said they would need to consult with their engineering department to obtain cost estimates to upgrade their system, and they might also need clearance from their Board of Directors, depending on the cost. He said that he would inform us of a specific plan to upgrade the system in a few weeks.
Except for improving the efficiency of the air cleaning system and locating the nearest cows, no action on the part of Mallinckrodt appears necessary at this time to assess the environmental impact of the iodine which is released since they are part of the Independent Measurements Program. A first approxi-mation with the raw air sampling data indicates that it is unlikely that Mallinckrodt's effluents result in any kind of problem. Air sampling data, coupled with meteorological data, are currently being processed and should provide a fair indication of where the iodine is going and in what concen-trations. Mr. Larry Denton told me on February 3, 1971, that, after this phase of their program is completed, they plan to take grass or milk samples 4
in the plant environment to round out the picture after the grazing season begins.
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Richard E. Cunningham Assistant Director for Plans and Technical Programs Division of Materials Licensing