ML20154J876
| ML20154J876 | |
| Person / Time | |
|---|---|
| Issue date: | 05/24/1988 |
| From: | Grimsley D NRC OFFICE OF ADMINISTRATION & RESOURCES MANAGEMENT (ARM) |
| To: | Heike P AFFILIATION NOT ASSIGNED |
| References | |
| FOIA-88-261 NUDOCS 8805270162 | |
| Download: ML20154J876 (2) | |
Text
U.S NUCLEAR REGULATO3Y COMMISSION
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RESPONSE TO FRL'EDOM OF K X! '^^'
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INFORMATION ACT (FOIA) REQUEST oxut weie s,,,
..ggpan Ef0VEStin Mr. Paul R. Heike PART I.-RECORDS RELEASED OR NOT LOCATED (See checaed bones)
No agency records sutreet to the roovest Fave been located No additonal agency records subiect to the sequest have been located Agency records subr ct to the roovest that are contif ed e Appendia are alreadv avasiatde for putsuc erspecton and copeng its the NRC Ptblic Document Room.
e 1717 H Street, N W, Washegton. DC g
Agency records tutfeet to the request th?t are identifed in AppeQu,__
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are being,r.3e,,adae e,o, put+c spec,.m are coe,ing e the Na C pun.ic Dom,,
Room.1717 H Street N W, WasNngton. DC, en a fo6 der under tNs FOt A eumber and teowester name The nonpropretary vers on of the proposaksi test you agreed to accept e a teierhone conversaton *sth a member of my sta'f a now teing made avadacie for public enspector and coveg at the NRC Putdic Docurrent Room,1717 H Street, N W. WasNogton DC, e a fo6 der urder tNs FO(A number and requester name Enclosed e inforerat->n on how you may octan access to and the c*arges for copyeg records placed in the NRC Pwbbc Document Room,1717 H Street. N W., Washegton. DC Agency records sutect to the re@est are enc'Jsed Any appkatse charge for Cop'es of the records pecMed and DavNnt procedu es te noted in the f omments secton r
Records svbrect to the roovest haie been referred to another Federes agencres) for reven and direct enpons* to you In view of NRC s respoese to the roovest. no fu ther acton a teeg taken on appeal W.er dated r
PART 11.
INFORM ATION WITHHELD FRDM PUBLIC DISCLOSURE Csrta.n informaton e the requested records e being withheld from putdec disclosure pu suant to the FOIA enemotons descreed in and for the reasons stated in Part H sec-r tons 8. C. and D. Ary re4ased portons of the docurneets for wNch ordy part of the record rs beeg withhe44 are beeg made avadat44 for publ+c en$ pecten and copying en the NRC Public Document Room.1717 N Street. N W.. Washrgton. DC. e a fo der under tNs FOIA number sad reovesier name.
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APPENDIX A DOCUMENTS TO BE RELEASED F0IA REQUEST NUMBER 88-261 DATE ORIGINATOR RECIPIENT DESCRIPTION 1.
10/24/83 T. Murley, NRC, M. Stolberg, New Notice of Violation Region 1 England Nuclear Corp.
(Inspeciton Nos.
(NENC) 83-01 and 83-02)
(5 Pages) 2.
2/5/85 T. Martin, NRC, M. Stolberg, E.I.
Inspection No.
Region 1 Dupont Biomedical 30-04581/84-02 Dept., NEN Products (35 Pages) 3.
3/6/85 T. Murley, NRC, Notice of Violatior.
Region 1 (Inspection No.
84-02) (5 pages)
UNITED ST ATES p ate et * '
'o NUCLEAR REGULATCRY COMMIS$10N g
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$31 PARK AVENUE KING OF PRVlll A. PENNSYLVA%' A 19406
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October 24, 1983 Docket Nos. 030-04579 030-04581 030-04704 EA 83-115 New England Nuclear Corporation ATTN:
M. A. Stolberg President 575 Albany Street Boston, Massachusetts 02118 Gentlemen:
Subject:
Notice of Violation (Inspection Nos. 83-01 and 83-02) l This refers to the inspection conducted by Messrs. C. Rowe and J. Nicolosi of this office on April 25 - 29, 1983 and to the inspection conducted by Mr. Nicolosi on June 27 - 28, 1983, of activities authorized by NRC License Nos.
20-00320-09, 20-00320-13, and 20-11868-01.
The reports of these inspections were forwarded to you on September 10, 1983.
The inspections were conducted to review the circumstances associated with three violations of NRC requirements which were identified by your staff and reported to the NRC.
These violations were discussed at an enforcement conference held with members of your staff on September 27, 1983. At that conference, the cause of the violations and your corrective actions were also discussed.
The first violatien involved exposure of a worker to concentrations of airborne radioactive material in excess of the quarterly limit.
The radiation dose re-ceived by the individual from exposure to these concentrations was not in excess i
of regulatory limits.
The exposure occurred after a glass reaction flask con-taining tritium cracked during flame sealing, thereby releasing airborne tritium and causing the exposure.
The second violation involved transportation of pack-ages containing licensed material with dose rates in excess of regulatory limits.
Tht causes of this violation included:
(1) inadequate shielding of the radioac-tive material because of voids in the lead shielding; (2) use of nonconservative acceptance criteria which was very close to the transport limit programmed into the radiation level measurement system computer and, (3) inadequate determina-tion of background radiation measurements because of other packages containing radioactive material in the areas where such measurements were taken. The third violatier involved shipment of a cask containing licensed material when the cask was thought to be empty.
As a result, the cask was mislabeled, and the shipping papers were incorrect.
This violation occurred because of inadequate control of incoming and outgoing casks in that they were stored in the same area. There-fore, a cask, mistakenly thought to be empty, was shipped back to the original supplier.
These violations have each been categorized as Severity Level 111 in accordance with the NRC Enforcement Policy (10 CFR 2, Appendix C).
Normally, a civil pen-alty is proposed for a Severity level 111 violation; however, we have exercised our discretion, after consultation with the Director of the Office of Inspection n Su a
,k) y
New England Nuclear Corporation 2
and Enforcement, and have decided not to propose civil penalties for these vio-lations.
In making this decision, we have considered the facts that (1) the first event, involving rupture of the glass reaction flask, appears to be an isolatec occurrence caused by equipment failure; (2) each event was promptly reported to the NRC by telephone and in writing, even though the two transporta-tion events were not required to be reported; and (3) your corrective actions were prompt and comprehensive.
Nonetheless, we emphasize that similar viola-tions in the future may result in additional enforcement action.
You are required to respond to the enclosed Notice and should follow the in-structions specified therein when preparing your response.
In your response you should also include a description of your quality assurance program for all shipping containers to ensure that all components meet critical specifi-cations and that future shipments comply with all appropriate requirements.
Your written reply to this letter and the results of future inspections will be considered in determining whether further enforcement action is appropriate.
In accordance with 10 CFR 2.790, a copy of this letter and its ent"osures will be placed in the NRC Public Document Room.
The responses directed by this letter and the enclosed Notice are not subject to the clearance procedures of the Office of Management and Budget, as required by the Paperwork Reduction Act of 1950, PL 96-511.
i Sincerely, Thomas E. Marley Regional Administrator
Enclosure:
i Public Document Room (POR) i Nuclear Safety Information Center (NSIC)
Commonwealth of Massachusetts (2) 1
NOTICE OF VIOLATION New England Nuclear Corporation Docket Nos.
030-04579 Bosten, Massachusetts 02118 030-04581 030-04704 License Nos. 20-00320-09 20-00320-13 20-11868-01 EA No.83-115 On April 25 - 29, 1983 and June 27 - 28, 1983, NRC inspections were conducted to review the circumstances associated with three violations of NRC requirements which were reported to the NRC by New England Nuclear Corporation (NENC).
EVENTS ASSOCIATED WITH VIOLATION A On November 18, 1981, a laboratory technician was exposed to the equivalent of 1248 maximum permissible concentration (MPC) hours of tritium, which is 2.4 times the limit specified in 10 CFR 20.
This event was reported to the NRC at that time by telephone. A followup report was provided the NRC in a letter dated December 10, 1981.
A review of this incident indicated that a worker was flame sealing a glass reaction flask containing 30 curies of tritium in an exhaust hood.
This procedure, approved by the Radiation Safety Committee, is performed daily.
For reasons that could not be determined during the licensee's evaluation and review, the flask cracked and permitted the tritium to be released.
Although the maximum permissible concentration for airborne tritium was exceeded, dose calculations by the licensee indicated that the worker's whole body absorbed dose from this exposure was 900 millirem.
The dose was limited by the timely action of the supervisory staff in decontaminating the worker immediately.
EVENTS ASSOCIATED WITH VIOLATION B.1 In November,1981, NENC shipped two molybdenum-99/ technetium-99m generators j
with Radioactive Yellow 111 labels.
Their clients measured radiation levels i
exceeding 200 rail 11 roentgen per hour at the surf ace and 10 milliroentgen per hour at one meter. HENC promptly informed the hRC of the event by telephone and also in letters dated December 12, 1981, and January 13, 1982.
Licensee evaluation o' the incidents identified three problers, namely, j
(1) the generator lead pigs contair.ed voids which provided less than were not detected at the final transport index check; (2) the acceptance adeouate shielding, allowing narrow directional beams of radiation which criterion programed into the external radiation icvel measurement system computer was not conservative in that it was very close to the transport limit; and, (3) a large number of generator. packages in the adjacent loading dock area increased background radiation significantly, making i
accurate measurements difficult.
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EVENTS ASSOCI ATED WITH VIOLATION B.2 On June 8,1983, an NENC representative reported to the NRC by telephone that a Type B quantity of sulfur-35 in a sealed capsule had been inadver-tently shipped on June 2,1983, in what was thought to be an empty con-tainer. As a result, the package was mislabeled and shipping papers were incorrect. A written report was also provided to the NRC.
NENC had originally received a shipment of sulfur-35 from the University of Missouri on June 1,1983, and it was placed in temporary storage to await processing.
Incoming and outgoing shipping casks were stored in the same This cask, with the security seal still intact, was mistakenly area.
thought to be empty by a lab technician.
Though it was not clear how the cask was labeled as "empty," this cask, along with four other empty casks, were shipped back to the original supplier.
The labels on the cask and the shipping papers indicated that the container was empty except for its uranium shielding.
Once NENC personnel recognized what had happened, they immediately traced the container to the original shipper and notified them that the cask still contained the sulfur-35.
The original shipper found that their original security seal was intact.
Normally, civil penalties are proposed for Severity Level III violations or events; however, civil penalties have not been proposed for these violations because (1) the violations were promptly identified and reported to the NRC by telephon: and in writing; and, (2) corrective actions were prompt and conipre' hensive. In addition, Violation A does not appear to have been the result of either inproper training or inadequate procedures.
In accordance with the NRC Enforcement Policy (10 CFR 2, Appendix C), the particular violations associated with these events are set forth below:
A.
10 CFR 20.103(a)(1) requires that no individual in a restricted area be ex-posed to radioactive material such that the uptake by any crgen from either inhalation or absorption or both routes of intake in any calendar quarter exceed that which would result from inhaling such radioactive material for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week for 13 weeks - in other words, 520 hours0.00602 days <br />0.144 hours <br />8.597884e-4 weeks <br />1.9786e-4 months <br /> at the maximum permissible concentration specified in 10 CFR 20, Appendix B, Table I, Column 1.
Contrary to the above, as a result of the cracking of a glass reaction flask, one individual working in the restricted area during the fourth calendar quarter of 1981 war exposed to tritium in an amount equivalent to 1,248 MPC hours for the tritium limit specified in 10 CFR 20, Appendix B, Table 1, Column 1, and this 1,248 MPC hours is in excess of the limits of 10 CFR 20.103(a)(1).
This is a Severity Level III violation (Supplement IV).
B.
10 CFR 71.5(a) requires that no licensee deliver any licensed material to a carrier for transport without complying with the applicable requirements of the regulations, appropriate to the mode of transport, of the Department of Transportation in 49 CFR parts 170 - 189.
1.
49 CFR 173.393(i) requires that all radioactive material be packaged in suitable packaging so that at any time during normal conditions incident to transprtation, the radiation dose rate does not exceed 200 millirem per hour at any point on the external surface of the package and the transport index does not exceed 10.
Contrary to the above, packages containing molybdenum-99/ technetium-99m generators were shipped by the licensee in November,1981, and were received at Las Vegas, Nevada, and Lubbock, Texas, on November 10, 1981 and December 11, 1981, respectively, and the packages had respective radiation dose rates of at least 220 and 400 millirem per hour at the surface and respective transport indices of 12 and 12.
This is a Severity Level III violation (Supplement V).
2.
49 CFR 172.403(g) requires that each package of radioactive material, unless excepted f rom labeling by $173.391 or $173.392, be labeled, as appropriate, with content and the number of curies.
49 CFR 172.202(a)(1) requires that the shipping papers include the proper shipping name described in 172.101 or 172.102.
Contrary to the above, on June 3,1983, a package containing a Type B quantity of sulfur-35 shipped from NENC was received at Columbia, i
Missouri, and the Radioactive Yellow-II label and the shipping papers did not identify the contents as sulfur-35.
This is a Severity level III violation (Supplement V).
Pursuant to the provisions of 10 CFR 2.201, New England Nuclear Corporation is i
hereby required to submit to this of fice within thirty days of the date of the
)
letter which transmitted this Notice, a written statement or explanation in reply, including: (1) the corrective steps which have been taken and the results achieved; (2) corrective steps which will be taken to avoid further violatic7s; and (3) the date when full compliance will be achieved.
Where good cause is shown, consideration will be given to extending this response time.
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UNITED STATES j
NUCLEAR REGULATORY COMMISSION F
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t 631 PARK AVENUE KING oF PRUSSIA, PENNSYLVANI A 19406 February 5, 1985 Docket No. 030-04581 License No. 20-00320-13 E. 1. DuPont, Biomedical Department ATTN: Mr. M. A. Stolberg President NEN Products 575 Albany Street Boston, MA 02118 Gentlemen:
Subject:
Inspection No. 030-04581/84-02 This refers to the special safety inspection conducted by Mr. C. T. Oberg of this office on December 11 and 20, 1984, of activities authorized by NRC t
License No. 20-00320-13 and to the discussions of our findings held by Mr.
i Oberg with members of your staff at the conclusion of the inspection, end to a subsequent telephone discussion between Mr. E. E. DeMaria and Mr. Oberg on January 4,1984.
This also refers to the telephonc discussion between Dr. J.
E. Glenn of this office and Mr. D. Dumas of your staff on January 29, 1985.
Areas examined during this inspection are described in the NRC Region I Inspection Report which is enclosed with this letter.
Within these areas, the inspection consisted of selective examinations of procedures and representative records, interviews with personnel, measurements made by the inspector, and observations by the inspector.
Our inspector also verified the steps you have taken to correct the violation brought to your attention in the enclosure to our letter dated September 25, 1984.
The steps you took to correct this item appear to have been inadequate; this item has recurred.
As discussed during the telephone conversation between Mr. Dumas and Dr.
Glenn, the apparent violations identified during this inspection will be discussed at an Enforcement Conference at our office in King of Prussia, Pennsylvania at 1:00 p.m., February 11, 1985.
We understand that members of your staff will attenc this ineeting. They should be prepared to discuss the causes of these apparent violations and your proposed corrective action.
Enforcement action for these violations will be considered following the Conference.
The NRC Enforcement Policy is described in Appendix C of 10 CFR Part 2, a copy of which is enclosed for your information.
In accordance with 10 CFR 2.790(a), a copy of this letter and the enclosures will be placed in the NRC Public Document Room.
1 E. I.=0uPont 2
No response to this letter is required.
Your cooperation with us in this matter is appreciated.
Sincerely, lE ets,s' omas T. Mar to, Director Division of Radation Safety and Safeguards
Enclosure:
- 1. NRC Region I Inspection Report No. 030-04581/84-02
- 2. 10 CFR Part 2 cc w/ encl:
Public Document Room (POR)
Nuclear Safety Information Center (NSIC)
Commonwealth of liassachusetts State of New Jersey I
bec w/ enc 1:
Region I Docket Room (w/ concurrences) i Senior Operations Officer (w/o enc 1) i J. Allan, DRA 1
- 0. Holody, RI J. Axelrad, IE J. Lieberman, ELD J. Glenn T. Oberg J. Joyner 4
/
U.S. NUCLEAR REGULATORY COMMISSION REGION I Report No.
30-04581/84-02 Docket No.
030-04581 License No.
20-00320-13 Priority 1
Category B
Licensee:
E. I. DuPont, Biomedical Department NEN Products 575 Albany Street Boston, Massachusetts 02118 Facility Name: New England Nuclear products Inspection At:
Bi'lerica, Massachusetts and Murray Hill, New Jersey i
Inspection Conducted:
December 11 and 20, 1984 Inspector :
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- .T.Oberg,RadiationSpecialist date Approved by:
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/ John E. Glenn; Ph.D., Chief, date Nuclear Materials Safety Section B
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Inspection Summary: Inspection on December 11 and 20, 1984 and (Report i
No. 030-04581/84-021 Areas Inspected: Special, announced inspection, including a review of the Customer Service Department license verification system operations; packtging and shipping; and package certification program.
Results:
Two apparent violations were identified: failure to adequately perform a license verification prior to the transfer of licensed material; and foilure to prepare a package to maintain radiation levels below regulatory limitt, during transport.
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DETAILS 1.
Persons Contacted G. Rocco, Site Manager
- D. Dumas, Manager, Operational Safety
- E. DeMaria, Senior Distribution Analyst "S. Roy, Supervisor, Radiation Protection and RSO for Medical Diagnostics R. Lopilato, Supervisor, Shipping Department A. Loiselle, lead Shipper M. Andella, Manager, Customer Service S. Lacivita, Supervisor, Customer Service
- Denotes those at both entrance and exit interviews 2.
General i
This special inspection wss conducted to examine the licensee s package certification program, and packaging and shipping programs as the result of a damaged package received by one of the licenste's customers.
In addition, the licens9e's customer service license verification process was reviewed because material had been transferred to an NRC licensee who was unauthorized to receive, use or possess it.
3.
Organization The licensee organizational structure and management reorganization dis-cussed in the 84-01 report has been completed.
No violations were identified.
4.
Transfer of Mater al s
Unauthorized Transfer of Byproduct Material:
During this inspection a review was performed of the circumstances surrounding transfers of sulfur-35 to an NRC licensee not authorized to receive the material.
In February, May, September, and October of 1984, an NRC licensed hospital ordered surfor-35 (1 to 5 millicuries of tagged methionine) from E. I.
DuPont, NEN Products.
The material was for nonhuman use in the hospital's research department.
NEN Products accepted the order after their Customer Service Department performed routine license verification review.
The material was packaged and transferred to the client hospital.
On or about December 14, 1984, the client hospital research department wanted to order more sulfur-35 tagged methicnine.
The Chief Technologist, new in the hospital Nuclear Medicine Department for just one month, could not determine from their license if they were authorized for sulfur-35.
She called E. I. DuPont, NEN Products to verify their authorization. At
2 this juncture, E. I. DuPont, NEN Products determined that the client hos-pital was not authorized to receive the material, that the same material had been transferred to the hospital without authorization on four previous occasions during 1984, and that an error had been made in their procedures that allowed the material to be transferred.
NEN Products informed the client hospital that the material would not be transferred to the hospital until proper authorization was obtained from the NRC. On December 14, 1984, NEN Products informed NRC Region I of the unauthorized transfers.
E. I. DuPont, NEN Products, investigated the circumstances surrounding their release of material to an unauthcrized recipient.
Based on the review, they determined that the errors were made by the Customer Service Department License Verification Group at the time that the orders for the sulfur-35 were placed.
The errors were the result of incorrect reading or interpretation of the customer verification information displayed on their computer's CRT screen.
To have accepted the order, the customer verifica-tion display should have indicated authorization under 33.100 (referring to authorization for non-human use materials under 10 CFR 33.100). Instead, the display showed 35.100 (referring to authorization for human use mater-ials under 10 CFR 35.100).
The technician reviewing the computer CRT, mis-takenly read it as authorization for 33.100 materials and not the actually authorized approval for materials under 35.100.
The orders were approved and the material was subsequently transferred to the client hospital. This 1s an apparent violation of 10 CFR 30.41(c), which requires a licensee to i
verify the transferee's authorization to receive the type, form and quan-tity of byproduct material to be transferred.
E. I. DuPont, NEN Products took immediate corrective action by retraining personnel and providing each with a memorandum, copy attached as Exhibit A, requiring them to verify all NRC licenses that disolay licensure under 33.100 (10 CFR 33).
In addition, NEN Products is considering an audit of the license verification system to identify areas that need improvement (see attached Exhibit B).
Long range corrective action will be to program their license verification computer system to distinguish between requests for cateriais under 10 CFR 33.100 and 10 CFR 35.100, and thus preclude processing of an incorrect order by "flagging" or blocking unauthorized requests.
This incident was attributed by the licensee to human error.
NEN represen-tatives stated that such errors have been calculated to have occurred at a rate of less than 0.01 percent for the number of byproduct materials orders received and shipped by E. I. DuPont, NEN Products during 1984.
5.0 Shipping Incident Significant Reduction of Package Integrity:
Ouring this inspection the inspector reviewed the E. I. DuPont, NEN Products package certification program and packaging / shipping of byproduct materials being transferred to persons authorized to receive and possess the material.
This review was performed because a package containing about 465 millicuries of cobalt-58 had undergone a significant reduction in integrity during transportation.
i 3
r The reduction in integrity resulted in radiation levels in excess of allow-able limits and deformation of both the internal and external packaging.
The package was not shipped by exclusive use vehicle.
On December 11, 1984, NRC Region I NRC was informed by a licensee in Murray Hill, New Jersey a t they had received a package from NEN Products the bottom surface of which measured about 400 millirem per hour (rtAem/hr), a level in excess of the 200 mrem /hr regulatory limit.
The package containeri a source of cobalt-58 electroplated on a metal disc and shielded within a Type M lead safe (~6 inches in diameter X -8 inches high). The package had split at the bottom seal such that only the straps around the package kept the styrofoam insert and lead shield contained within the package.
(See attached Exhibit C). At approximately the same time, the licensee also notified NEN Products and the carrier (Federal Express) of the situa-tion.
This package was subsequently opened (December 11,1984) in the presence of an NRC Inspector.
(See attached Exhibits C and D). No radioactive contamination levels were significantly greater than background.
Direct reading survey measurements made by both the licensee and the inspector showed that radiation levels at tee bottom of the package were in the range of 400 to 450 mR/hr on contact and about 3 mR/hr at one meter.
10 CFR 71.47, External Radia!. ion Standards for All Packages, requires that a package must be designed and prepared for shipment so that the radiation level does not exceed 200 mR/hr at any point on the external surface of the package and the transportation index does not exceed 10.
10 CFR 71.5, Transportation of Licensed Material, requires that each l'.cen-see comply with applicable requirements of 00T in 49 CFR Parts 170 through 189.
49 CFR 173.441(a), Raciiation Level Limitations, requires that each package of radioactive materials orfered for transportation be designed and pre-pared for shipment so that under conditions normally incident to transpor-tation the radiation level does not exceed 200 mR/hr at any point on the l
external surface of the oackage and the transportation index does not exceed 10.
1 Apparently because cf mishandling while within the transportation sys-tem, the lead shield inside of the package did not remain in place.
Under the conditions of transportation, the weight of the shield crushed and compacted the styrofoam packaging in the top and bottom sections of the package. This effectively changed the geometric configuration of the source &nd si.ield and produced the higher (bottom) surface radiation reading. The contracted carrier flys all packages into their central terminal in Atlanta, Georgia.
From there, the packages are rerouted to their final destinations.
Careless package handling at any point along these routes could have caused this problem.
Package handling techniques, plus the short residence time at any specific terminal or staging point, would effectively minimize the likelihood of any individual receiving a significant radiation exposure (greater than 500 mrem) to the whole body.
I 4
Based upon the condition in which this package was received, plus the ex-ternai surface high radiation level, it appears that the Jackage was not designed and prepared to maintain the radiation level within the regulatory limit of 200 mR/hr.
This represents an apparent violation of 10 CFR 71.47 and 49 CFR 173.441(a) referenced in foregoing paragraphs.
Immediately upon notification of the damaged package incident, NEN Products reviewed their testing results and initiated packaging design modification.
A packaging modification was subsequently tested and incorporated into packages containing Type M Lead Safes.
The modifications eliminated pos-sible shifting of the safe within the package during transportation, pre-venting loss of package integrity even subsequent to a 30-foot drop test.
All shipments of Type M Lead Safes containing byproduct materials were i
held up until testing of the packaging modification was completed and approved. The attached Exhibit G, memtrandum dated Dec' ember 20, 1984, describes the packaging modification and includes copies of photographs taken of the 30 foot drop test.
At E. I. DuPont, NEN Products, facilities, the inspector reviewed the Type A packaging testing results.
The testing was performed by Environmental l
Testing Corporation, Acton, Massachusetts, (Report No.12123) during March 1976. The certification for package No. 501010 (Box, Generator) was signed and notarized en March 24, 1976.
This DOT 7A Packaging was designat 1 for:
"Any fitting generator assembly unit or any fitting containment vesset with or without lead shielding and absorbent material for all liquids capable of absorbing twice the total volume of such liquids", in accordance with spe-cifications shown in the attached Exhibit E and having passed the required tests outlined in 10 CFR 71.
The certification and testing is shown in the attached Exhibit F.
The testing did not include the same packaging with the Type M Lead Safe.
The inspector also examined the modified packaging as described in Exhibit G.
This appears to preclude further similar. problems with this package. The licensee, is considering future modification of the packaging to employ various polyethylene copolyners that are very resilient and will not deform under conditions of high impact.
The packaging and shipping department was inspected and the inspector deter-mined that the handling conditions there would not result it; deformation of the packate as observed on receipt of this specific packago.
4.
Exit Inthview On December 20, 1984, an exit interview was held with those indivi6als indicated in the Persons Contacted section of this report'.
The inspector reviewed his findings, discussed the violations, and reviewed the enfcrce-ment options open to the NRC.
The inspector also informed the licensee that they would be advised by telephone of any significantly different enforcement action to be taken other than discussed during the exit inter-view.
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XOl Ok9I December 17, 1984 T0:
All Customer Service Reps FROM:
S. Lacivita Effective imediately, when the "LB" license screen displays 33.100 on an NRC license and the order con be licensed only under 33.100, the order should be brought to the License Verification Group for verification.
This does not apply to 35.100 products, which are used as radio '
pharmaceuticals.
if you have any questions please let me know, cc:
M. Andella K. D. Doyle K. Nicoli G. Solomon 1
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, nam o
- o 1K 16 01.
cc:
W. D. Findley D. Doyle K. Nicoli G. Solomon A. Pepicelli D. Dumas MEM0RANDUM To:
- 5. J. Lativita December 18, 1984 From: M. V. Andella h license Verification Audit I would like you to initiate a License-Verification audit. Thep!rimary objective of this audit will be to identify areas of our License Veri ication process which need improvement, i
Some of my reconnendations are:
Initially, weekly audits
- tapering off to quarterly
- beginning week of 12/17/84
- continuing indefinitely Audit comittee consisting of one supervisor and two Customer Service Representatives.
- Membership on ccmittee for all Customer Service Reps and Customer Service Supervisors, myself included, will be mandatory on a rotational basis.
)
- I strongly reconnend Distribution Supervisors serve as members also.
- You will act as consultant to eacn committee as well as schedule members on committee and schedule audits.
Audit committee will select random sample of orders processed the day of the aujit.
- They will review the license verification procedure used on each of the orders selected.
- They will report results of audit to management.
An additional benefit from this program can be an increased aware-ness of our responsibility and a better understanding of the requirements of an excellent license verification system.
N Rage 2 NEN Products' license verification system was always known as the best in the business.
If we approach this project enthusiastically and optimis-tically, we will succeed in maintaining that reputation.
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CERTIFICATION OF PACKAGING WITH RESPECT TO COMPLIANCE WITH DOT SPECIFICATION 7A PERFORMANCE REQUIREMENTS.
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I ERMES DEMARIA COMPLIANCE AND 1
OPERATIONS ANALYST CORPORATE DISTRIBUTION NOVEMBER 30, 1977 i
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TYPE A PACKAGING Type A packaging is that which must be designed in accordance with the applicable general packaging requirements as prescribed in the Hazardous Materials Regulations of the Department of Transportation, and which must be adequate to prevent the loss or dispersal of its. radioactive contents and to maintain its shielding properties when the package is subject to "normal" conditions of transport.
The regulations prescribe the performance criceria that simulate the "normal" conditions of transport.
It in against this criteria that a shipper must make his assessment of the adequacy of the package design.
The shipper of each DOT Specification 7A must_be prepared to provide. to the Department of Transportation a complete certification and supporting safety analysis demon-strating that the construction methods, packaging design, and materials of constructions are in compliance with the specification.
The packagings presented in this document have been tested and found to be in compliance with the requirements of DOT Spec. 7A.
The safety analysis for each package is on file with the Compliance and Operations Analyst of the Corporate Distribution Office.
Small quantities of Radioactive Material that meet the ragulatory conditions for limited quantity designation are excapted form DOT Spec. 7A packaging.
CONTENTS DESCRIPTION STOCK NO.
APPROXIMATE USAGE PER YEAR (1979)
SECRUITY SEALS TIBERBOARD BOX, 9 1/8 x 9 1/8 x 7 1/4 3-0185 3,500 FIBERBOARD DRY ICE BOX, 25 lbs.
3-0089 20,000 FIBERBOARD DRY ICE BOX, 10 lbs.
3-0084 10,000 FIBERBOARD BOX, 18" FLOOD PHANI.H 3-0200 500 T'BER30ARD BOX, 14" FLOOD PHANTOM 3-0199 800 FIBERBOARD BOX, TELESCOPING 3-0190 185,000 J,IBERBOARD BOX,, crnnA1TR 4 4-43010 47,500 FIBERBOARD BOX, LEAD PIPE 5-03013 18,000 FIBERBOARD BOX, XENON PIPE 5-03018 8,000 DOI SPEC 55 CONTAINER WOOD BOX, 3E1800 CYLINDER WOOD BOX, DOT SPEC 19A XXX STEEL DRUM, DOT 17H (55 GALLON)
STEEL DRUM, DOT 17C (55 CALLON)
CARTON, MULTILRIIT, 25 UNIT 3-0197 2,500 CARTON, MULTIUNIT, 50 UNIT 3-0198 2,500
{
1
MEMORANDUM i
September 30, 1977 EDM/ Comp-002-77 TO:
Dis tribut. ion FROM:
Ermes DeMaria
SUBJECT:
Security Seals for Radioactive Material Packagings.
The outside of all packages containing radioactive material shall have some type of seal which is -
1.
not readily breakable and 2.
while intact will be evidence that the package has not been illicity opened.
Tape bearing the NEN logo meets the above requirements for a security seal.
For a package that cannot be taped, a lead, wire sealed with a plug stamped with NEN designator is acceptable.
I have ordere6 a supply of wires and plugs with a number of devices that will crimp the plug to the wire.
Radioactive material packe.gings will be accepted in the
' distribution tystem only with approved DOT sdcurity seals.
i Distribution:
T. Peppicelli G. Law.
S. Kerekes M. Batchelder.
C. Killian R. Tonnesen EDM/js
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DOT 7A PACKAGING
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OUTER PACKAGE INNER PACKAGING CONTAINMENT VESSEL STOCK NO.
DESCRIPTION WGHT. LIMIT l STOCK NO.
DESCRIPTION Any fitting Generator
-6=01010 -
BOX, GENERATOR 65 lbs.
5-01067 Styrofoam (insert)
Part A assembly unit, CORRUGATED 5-01068 Styr foam (insert)
Any fitt ng containment vessel with or without i
lead shielding and absorbent 0-30800 Asphaltic Tape material for all liquids with NEN logo capable of absorbing twice i
the total volume of such liquids.
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AUTHORIZED CONTENTS:
TYPE A QUANTITY OF RADIOACTIVE MATERIAL IN NORMAL FORM.OR SPECIAL FORM.
O REQUIRED MARKINGS:
"USA DOT 7A TYPE A", "RADIOACTIVE MATERIAL".
i TEST REPORT NO.:
12123 ACTION ENVIRONMENTAL TESTING CORPORATION, MARCH 24,1976 i
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E.I. DU PONT DE NEMOURS & CO. (INC.).
BIOMEDICAL PRODUCTS DEPARTMENT 1
January 4, 1985 C.
Thor Oberg USNRC Region I 631 Park Avenue King of Prussia, PA 19406 Dear Mr. Oberg; Enclosed are the photographs you requested.
The photgraphs were j
taken after the 30 ft. drop test of the 14 x 14 x 14 in. carton identified in the Acton Environmental Test Report No. 12123, March 24, 1976, as package B.
A measurement of the current gen-erator box verified that the size of the carton has not changed:
it is still 14 x 14 x 14 inches.
Please feel free to contact me if further informations is required.
You s tr ly,
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E.E. DeMaria Sa.*ety & Environmental Control oc:
D. Dumas I
Site Safety Ofcice j
NEN Products, Billerica l
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I NEN MEDICAL PRODUCTS 544 Albany Street. Boston. Massachusetts 02118 Telephone 617 482 9595 Teles 94-0996 1
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actom S33 M A IN St At E f. ACTON. MASSACHUSE 71$ 01720 18171263 2933 80Sf 0N S42 0237 I
Harch 24, 1976 j
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THIS IS TO CERTIFY that Packaoe f501010 (Box Generator) l containing (H099/TC-99M Generator) subraf tted by HEW ENGLAND NUCLEAR, has been tested to, and satts-i f actorily meets the requirements as specified in the i
DEPARTMENT OF TRANSPORTATION SPECIFICATION 7A.
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CERTIFIED BY: M
'K William J. Schreiner Project Engineer l
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Test Report No. 12123 12 No. of Po*ges Report of Test on ENVIRONMENTAL TESTING OF TYPE A PACKAGING FOR NEW ENGLAND NUCLEAR I
UNDER PURCHASE ORDER NO.17409 1
r NVIRONMENTAL ACTON CORPORATION Data March 17, 1976 Prepared Checked Approved IY W.Schreiner A.Dentino M.L.Tolf Wbl!uNoP n. & & h:{l]$
oct 34P/76 vhM9n.
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Administrative Dath 1.0 Purnet. of Teit!
To subject the packages to the envirohmental tests as specified hereir.,
2.0 Wnufac turers New England Nuclear i
i 3.0 wnufacturer's Tvee or Model Nor Six (6) different configura-tions of packaaina.
Department of Transportation 4.0 Drawina. sa.eirient.ian er Exhibit:
Specification Section 173.398(b) 5.0 Quantity of items Tested, fline (9) of each of the above type.
6.0 t.enrity cloutfientian af it.m..
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7.0 Dat. Test Camalated?
March 12, 1976 l
8.0 Test Conducted Bvr i
A.Dentino 9.0 Diannittien af Neim."
Returned to New En91and Nuclear.
10.0 Abstrac t, Refer to result sections herein.
l III23 Report No.
Page I
I NYWDONME NT AL
{
ACTON CORPonATX>e j
FOREWORD During this test program, 54 packages were subjected to the environmental tests as specified herein.
Six (6) different confiouratior.s of packages were submitted.
They were described as shown below:
A)
Two packaces strapped together.
The bottom package being 14-1/2" X 14 1/2" " 14-1/2" i
and the top package being 9 X 9-1/2" X 4-3/4".
B) 14-1/2" X 14-1/2" X 14-1/,2" C) 9-1/2" X 10-1/4" X 4-1/4" 0) 5" X 10" X 5" E) 5" X 10" X 5" F) 5-3/4" X S-3/4" X 8-1/2" Nine (9) of each of the above packages were serialized and submitted to the following:
SERIAL NUMBEP.
ENVIRONMENT 1
High Temperature 2
Low Temperature J
Altitude 4
Compression 5
Water Spray & Freefall 7-Water Spray & Corner Drop 8
30-foot Drop 9
Vibration l
Each pLckage was only exposed to one of the environments listed, excent on Hos. 6 & 7 where water spray was per-formed before the freefall and the corner drop.
Following the environments, the condition of the packagine was noted and the packages were opened and a visual exam-1 ination of the centents wat made.
keput No. _1212 3 twueoNutNTAL ACTON 2
- rage
) conoam J
1.0 REOUIRE})ENT
S. PROCEDURE
S & RESULTS 1.1 H_ EAT 1.1.1 Reoutrements The test samples shall be subjected to the heat test as specified in Section 173.398 of the Dept.
)
of Transportation Soecification 7A, para, 2(1).
1.1.2 Procedures Each of the test samples was placed within a Conrad High Temperature Chamber and exposed to an ambient temperature of 130*F in still air for a period of B hours.
At the completion of this period, the internal temperature of the chamber was reduced to room ambient conditions and the test samples were visually examined.
1.1.3 R e_s ul t s There was no evidence of any physical damage to the i
packaoino and there was no evidence of any leakage of the packed contents.
Report No, 12123 l
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_.. _ _ _. _ _ _ _. _ _ _ _ _ _ _,,.. - _ _ _ _ _ _. _, _, _ ~ _ _.
1.2 COLO 1.2.1 Requirements The test samples shall be subjected to the cold test as specified in Section 173.398 of the Dept. of Transoortation Specification 7A. para. 2(11).
1.2.2 Procedure 1 Each of the test samples was placed within a Conrad Low Temperature Chamber and exposed to an ambient temperature of 40*F in still air for a period of 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br />.
At the completion of this period, the in-ternal temperature of the chamber was reduced to room ambient conditions and the test samples were visually examined.
1.2.3 Results There was no evidence of any physical damage to the packaging and there was no evidence of any leakace of the packed contents, i
i t
4 d
Reput No.
12123 l
l memn cfoN Po 09 -
cca m aro.
i
1.3
,R,E DU C E D. P RI S $UR E 1.3.1 Reguirements e
The test samples shall be subjected to the reduced pressure test as specified in Section 173.398 of the Dept. of Transportatien Specification 7A, para.
2(111),
1.3.2 Procedures The test samples were placed within a Tenney Eng-gineering Altitude Chamber ene the internal oressure of the chamber was reduced to a pressure of 0.5 atmosphera absolute (7.3 paia) simulated 18,000 feet.
This reduced pressure eat held for a period of 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> F011owing thit exposure, tha test samples were rwturned to room ambient c6nditions and visually examined for packatt damage or leatage.
1.3.3
,Re s ul t s There was no evidence of any physical damage to the packaging and there was no kvidence of any Isakage 1
of the packed content.b.
Reput bb. -- I 2 I 2 3 D N w y eac W M.
1 l
ACTON 5
Page
) cowoam s
b
1.4 YlBRAT!0N 1.4.1 Requirements The test samples shall be subjected to the vibration test as specified in Section 173.398 of the Dept.
of Transportation Specification 7A, para. 2(iv).
1.4.2 Procedures Each of the test samples was strapped to the move-able tabis of a Ling Vibration System Model A-249.
The test samples were subjected to the following sinusoidal and random vibration exposures:
SINUSOICAL 5-500 Hz at a sweep rate of I octave / minute at a level of 1.0g's RANDOM 2
10-50 Hz 9 0.034e fg, 50-350 Hz 9 -24db/ octave l
The overall a(rms) level was 2.8 and random vibration was for a period of 30 minutes.
The above vibration was parformed in each of three (3) mutually perpendicular axes.
Foilowino this exposure, the test samples were visually examined for any package damace.
1.4.3 Results There was no evidence of any physical damage to the packacing and there was no evidence of any leakace of the packed contents.
t 1
Report th,12123 i
i NY*O*h4 t NT A AC10 N 6
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1.5 WATER SPRAY & FREE DROP 1.5.1 Renuirements The test samplec shall be subjected to the water spray and free drop test as specified in Section 173.398 of the Dept. of Transportation Specification 7A. para. 3(9) and 3(11).
1.5.2 Procedures Each of the test samples was exposed $o a water spray to keep the entire exposed turface of the package continuously wet for a period of 30 minutes.
Between 1-1/2 and 2-1/2 hours after the conclusion of the water spray, the test samples were free dropped through a distance of 4 feet onto a flat un-yielding horizontal surface, striking the surfac6 in a position for which maximuin damage was exper ts i.
This was performed on the flat surfq;e of eacP package.
1.5.3 R e,s_u l t s On the 14-1/2" X 14-1/2" X 14-1/2" package, one edge was slightly creased.
No other damage was ncted to any of the packages and there was no evidence of leakage.
l 4
i Report No.
17123 a-tweacNutNTAL A CT Oilt y
Page a> >We n n@v
1.6 WATER OPRAY & CORNER OROP 1.6.1 Requirements The test samples shall be subjected to the water spray and corner drop test as specified in Section 173.398 of the Dept. of Transportation Specification 7A, para 3(i) and 3(111).
1.6.2 Procedures Each of the test samples was exposed to a water spray heavy enough to keep the entire exposed sur-face of the package contiiluously wet durino a period of 30 minutes.
Each package was then free dropped onto each corner of the package in succession from a height of 1 foot onto a flat unyielding horizontal turface.
Following this exposure, the test samples were vis-ually examined for package damace and leakage within.
1.6.3
_Re s u l t s i
A - packaces showed a creased corner en the smaller package and two seams split alono the bottom of the large package.
B - package showed the corners dented, slight sur-face splits along two edges on the bottom.
C - package thowed splits in the bottom edges and top corners.
In the top corners there were two approximately 1 inch splits in the covering.
0-E-F - packaces, the corners were creased.
There was r.o evidence of any leakace when the packaces were opened.
i i.,,,, s..
12'23 Acton 8
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CC8troptA7 04
t 1.7 P EllET R AT 10fi 1.7.1 Re,ouirements The test samples shall be subjected to the venetra-tion test as specified in Section 173.398 of the Dept. of Transportation Specification 7A. para, i
3(iv).
1 1.7.2 Procedures Each of the packages, in turn, was placed on an uncushioned flat horizontal surface.
A 1 1/4" diameter steel rod with a hemispherical end and weighing 13 lbs. was dropped from a height of 40 inches onto an exposed surface.
The long axis of the rod was perpendicular to the oackage surface at the instant of impact.
Following this test, the samples were visually examined for evidence of any physical damage.
On the double tied-together packages, the steel bar was dropped twice; once in each box.
1.7.3 Results On the double package units in the large package, approximately a 2-inch hole in the packing was r,oted and 5 splits in the cardboard from the steel bar extended from the hole up to 5 inches.
In all of the other packages, the steel bar oroduced hole approximately 2 inches in diameter.
P Following this environment, the test samples were visually examined for evidence of physical damage and leakage.
Except for the hole produced by the steel bar, no other damage was noted to any of the packages and there was no evidence of leakage, s
a Reputbk.
12123 I
occastNTAL l
.l ACTON 9
Page
)
concomaro.
i
r 1.8 COMPRESSION 1.8.1 Renuirements The test samples shall be sub.iected to the com-pression test as 5decified in Section 173.398 o" the Dept. of Transportation Specification 7A, para.
3(v).
1.8.2 Procedures Each of'the test samples, in turn, was subjected to a compression lotd equal to 2 lbs/sq. inch mu'ltiplied by the maximum horizontal cross section of the package.
NOTE:
THE SPECIFICATION REQUIRES A COMPRESSIVE LOAD EQUAL TO EITHER S TIMES THE WEIGHT OF THE PliCKAGE OR 2 LBS/SO.lNCH MULTIPLIED BY THE MAXIMUM WORIZ.
ONTAL CROSS SECTION OF THE PACKAGE, WHICHEVER IS GREATER.
ON ALL PACKAGES, THE 2 LBS/SQ. INCH RE-OUIREHENT WAS THE GREATER WEIGNT.
The required weights were applied uniform'ay against
{
the top and bottom of the packaoe with the package in the position in which the packaoe would normally l
be transported.
This load was applied for a period i
of 24 continuous hours.
The loads were as follows:
On A PACKAGE - that is, 2 packages tied together -
t 171 lbs.
During this test, the top small package area was calculated.
B PACKAGE - The 14-1/2" X 14-1/2" package - 421 lbs.
C PACKAGE - The 9-1/2" X 10-1/4" package - 195 lbs.
D PACKAGE
.5" X 10" 4 Vial 100 lbs.
E PACKAGE - 5" X 10" 5 Vial 100 lbs.
j F PACKAGE 3/4" X 5-3/4" 67 lbs.
i 1.8.3 Results 1
There was no evidence of damage,or leakaoe as a result of this test.
Report No.
I2I23 ACTON 10 pg,
?--- --.
7..-
1.9 30-F00T OROP TEST 1.9.1 Requirements a
fach of the test samples shall be subjected *to a 30-foot drop test as speci fied in para. 5.5.2 of American National Standa rd N14.7-1975.
1,9.2 Procedures Each of the test samples, in turn, was free-dropped through a distance of 30 feet onto a concrete flat horizontal surface.
Followino this environment, the test samples were visually examined for evidence of physical damage and leakage.
1.9.3 Results On PACKAGES A, the small package split and one lead pellet came out of the package.
On the large package there was a 4-inch split in the corner and a 4-1/2" split on top.
On PACKAGING B, there were two 2* holes in the side and one corner had pulled away from the staples in the package.
On the 25 VIAL PACKAGE C, t'he're was a 1-inch split along the seam.
On the TALL PACKAGE F, there was a 1-inch split along the seam.
On the $ VIAL PACKAGE E, there was no evidence of any damage and on the 4 VILL PACKAGE 0, there was no evidence of any damace.
Exceot for the small packaoe releasing the one lead pellet. there was no other loss of internal material and upon inspection there was no evidence of any leakage.
Reput No.
I2I23 l
l ACTON I1 p,g, c,--
2.0 TE_ST EOUIPMENT LIST 505E,,,,,,,,,,,,,M[gg:,,,,,,,,,MggE(,,,,,,,S[$Ng:,,,,33MgE,,,,,,,,,,,,,,,,,,,,,3ggy3Agy,INy f,C3[:[g[g,
Accolorometer B&KI 8302 344784 1 Hz - 5 KHz
+5%
AC320 3 months Lcg Converter Moseley 60D 299 0-60 DB
+0.5 db PE323 3 months tog Converter Moseley 608 844 0-60 D8
+0.5 db PE324 3 months i Enciter Ling A249 70 30,0007 force 1"P/P disp. +5%
Amplif ter Ling PP120/150 56 5 Hz - 5 KHz
[2%
PE317 1 month Eqec11rer/
80 channel auto / random Acolyzer MB TS69 422 10 Hz-4 KHz RG 50 db
+1 db PE321 1 month Input E=1,10,100 MY/in RacGrder X-Y HP 70358 1206A06843 1,10 V/in
+0.2%
RE336 3 months 1
Input E=1,10.100 MV/in accCrder X-Y HP 70358 1206A07017 1,10 V/In
+0.2%
RE337 3 months
!*?titede
-100* to +300*F
.hccbor Tenney 12ST 2762 100K' max.
+2*C CH301 3 months
' Tom 72rature 1 :hcabar Conrad C444 30760
-100' +0+200*F
+2*C CH307 3 months 1
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recertacr 20, 1984 WPE A P/GAGDJG FDDIFICATICt! 'ID G:!DrCR CARIUJ 501010 Pef: 1. Draf t FircraMum 12/14/P4 Typ !! Icad safe Fbdification
- 2. Acton Envirorm2ntal Certification Mirch 24, 1976
- 3. Acten Envirorrental Test Poport !6.12123 (3/12/76)
- 4. Photographs of 30 ft drcp 12/84 Type M Ftdificatien Generator packaging 505050 has been trolified to accept e type M lead safe.
FDDIFICATICti:
- 1. A ccrplete generator Type A pckaging ro. 501010
- 2. Each styrafcam ansert contains two pieces of 1.tyratoam spcers
- 3. A 1/2" plywocd insert with center hole and four wcoden plugs is placed between the tw styrafoam inserts.
- 4. A type M lead safe is placed within the center hole of the plywocd insert: held inplace and braced by the styra-foam inserts.
- 5. Two pieces of 1/2" plywccd support is place tcp ard bottm fone piece) between carton ard styrafoam insert.
- 6. Se carton is taped closed ard sealed with a security seal.
- 7. 7%o nylco strapes enempase the cmpleted package.
%e above :rdification is authorized for g/A2 quantaties of radioactive r:aterial in liquid or solid form. Specificatico markire r:ust be in otrpliance with 49 CFR 178.350.
Kv.irtra authorizcd weight: 70 lbs (gross)
FtKmDGRAPHS Ctl FILE (cocy attached).
tb rolification other than those authorizcd are to used.
E.E.Dt2hria Safey & Envircwental Control
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UNITED STATES 8'
NUCLEAR REGULATORY COMMISSION cc*
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ud. Glenn P. Lohaus Docket No. 030-04581 K. Abraham License No. 20-00320-13 Docket File EA 85-25 DJH - 3/6/85 E. I. OuPont, Biomedical Department ATTN: Mr. M. A. Stolberg President NEN Products 575 Albany Street Boston, Massachusetts 02118 Gentlemen:
Subject:
NOTICE OF VIOLATION (Inspection No. 84-02)
This refers to the NRC inspection conducted on December 11, 1984 in Murraf Hill, New Jersey and on December 20, 1984 at your facility in Boston, Massachusetts, of activities authorized by the NRC License No. 20-00320-13.
The report of the inspection was forwarded to you on February 5, 1985.
The inspection was conducted to review the circumstances associated with a viola-tion of NRC requirements involving the transportation of a package containing licensed material with radiation levels on the surface of the package in excess of the regulatory limit.
This violation was reported to the NRC by the recipient of the package, an NRC licensee in Murray Hill, New Jersey.
During the inspection, one other violation of NRC requirements was identified. On February 11, 1985, we held an enforcement conference with W. D. Findley and other members of your staf f during which the violations, their causts, and your corrective actions were discussed.
l The s iolation involving the tran s tation of the package with radiation levels r
on the surface in excess of the regulatory limit is classified at Severity
{
Level 111 in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C, as revised, 49 FR 8583 (March 8, 1984).
Although civil penalties are considered for Severity Level III violations, a civil penalty is not proposed in this case because of your prompt and comprehensive corrective actions taken in immediately stopping shipments of type M Le' i Safe until package modification and testing was completed, retraining personnel, and initiation of plans to develop a "fail safe" computer system for licensee verification.
Further, we commend the program you instituted pieviously of croviding training to your carriers of radioactive material.
Nonetheless, we emphasize that similar violations in the future may result in additional enforcement actions.
You are required to respond to the enclosed Notice and, in preparing your response, you should follow Ae instructions specified in the Potice.
In your response, you shoulo also document the corrective actians described at the enforcement conference.
Your reply to this letter and the results of future inspections will be considered in determining whether further enforcement action is appropriate.
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UNITED STATES Pi ) ?.
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631 PARK AVENUE gv f KING oF PRUSSIA, PENNSvLVANIA 194o6 i
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Docket No. 030-04581 License No. 20-00320-13 EA 85-25 E. I. DuPont, Biomedical Department ATTN:
Mr. M. A. Stolberg President NEN Products 575 Albany Street Boston, Massachusetts 02118 Gentlemen:
Subject:
NOTICE OF VIOLATION (Inspection No. 84-02)
This refers to the NRC inspection conducted on December 11, 1984 in Murray Hill, New Jersey and on December 20, 1984 at your facility in Boston, Massachusetts, of activities authorized by the NRC License No. 20-00320-13.
The report of the inspection was forwarded to you on February 5,1985.
The inspection was conducted to review the circumstances associated with a viola-tion of NRC requirements involving the transportation of a package containing licensed material with radiation levels on the surface of the package in excess of the regulatory limit.
This violation was reported to the NRC by the recipient of the package, an NRC licensee in Murray Hill, New Jersey.
During the inspection, one other violation of NRC requirements was identified. On February 11, 1985, we held an enforcement conference with W. O. Findley and other members of your staff during which the violations, their causes, and your corrective actions were discussed.
The violation involving the transportation of the package with radiation levels on the surface in excess of the regulatory lirait is classified at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C, as revised, 49 FR 8583 (March 8, 1984). Although civil penalties are considered for Severity Level III violations, a civil penalty is not proposed in this case because of your prompt and comprehensive corrective actions taken 11 immediately stopping shipments of type M Lead Safes until package modification and testing was completed, retraining personnel, and initiation of plans to develop a "fail safe" computer system for licensee verification.
Further, we commend the program you instituted previously of providing training to your carriers of
]
radioactive material.
Nonetheless, we emphasize that similar violations in the future may result in additional enforcement actions.
You are required to respond to the enclosed Notice and, in preparing your response, you should follow the instructic.1s specified in the Notice, In your response, you should also document the corrective actions described at the enforcement conference.
Your reply to this letter and the results of future inspections will be considered in deter;nining whether further enforcement action is appropriate.
- , ^'
1 J
E. I. DuPont In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and the enclosure will be placed in the NRC's Public Document Room.
The responses directed by this letter and the enclosed Notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.
Sincerely,
- e..
Thomas E. Murley Regional Administrator
Enclosure:
Notice of Violation cc w/ encl:
Public Document Room (PDR)
Nuclear Safety Information Center (NSIC)
Commonwealth of Massachusetts l
1 l
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,w
e NOTICE OF VIOLATION E. I. DuPont, NEN Products Docket No.
030-04581 Boston, Massachusetts 02118 License No. 20-00320-13 EA 85-25 A special NRC inspection was conducted at one of the licensee's customer facilities in Murray Hill, New Jersey on December 11, 1984, and at the licensee's facility in Boston, Massachusetts on December ^3,1984, to review the circurastances associated with the receipt at the Murray Hill facility of a package containing licensed material with radiation levels on the surface of the package in excess of the regulatory limit.
During the inspection, two l
violations of NRC requirements were identified.
In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C, as revised, 49 FR 8583 (March 8, 1984), the violations are set forth below:
A.
10 CFR 71.5 requires each licensee who transports lionsed material out-side the confines of its plant or other place of use, or who delivers licensed material to a carrier for transport, to comply with the appli-cable requirements of the Department of Transportation regulations in 49 CFR Parts 170 through 189, appropriate to the mode of transport.
49 CFR 173.441(a) requires each package of radioactive materials offered for transportation to be designed and prepared for snipment so that, under conditions normally incident to transportation, the radiation level does not exceed 200 mR/hr at any point on the external surface of the package.
Contrary to the above, on December 11, 1984, a package offered for trans-portation containing nominally 500 millicuries of cobalt-58 in a Type M lead safe, was not adequately designed and prepared for shipment under i
conditions nor ally incident to transportation in that the radiation level on the bottom of the external surface of the package was approximately 400 mR/hr when received at its destination in Murray Hill, New Jersey.
This is a Seve ity Level III violation (Supplement V).
B.
10 CFR 30.41(a) prohibits the transfcr of byproduct material except to an authorized recipient and 10 CFR 30.41(c) requires that, p or to transferring licensed material, the licensee transferring the material shall verify tnat the transferee's license authorizes the receipt of the type, form, and quantity of byproduct material to be transferred.
Contrary to the above, one to five millicurie quantities of sulfur-35 were transferred to St. Elizabeth's Hospital in BrighMn, Massachusetts, during February, May, September and October of 1984, wichout verifying 4
2 ~
Notice of Violation that St. Elizabeth's Hospital was authorized to receive the type, form and quantity of sulfur-35 shipper..
St. Elizabeth's Hospital was not authorized to receive this raaterial.
This is a Severity Level IV violation.
(Supplement VI)
Pursuant to the provisions of 10 CFR 2.201, E. I. DuPont, NEN Products is nereby required to submit to this office within thirty days of the date of the letter which transmitted this Notice, a written statement or explanation in reply addressing each alleged violation and including:
(1) admission or denial of the alleged violation; (2) the reasons for the violation if admitted; (3) the corrective steps which have been taken and the res.Its achieved; (4) corrective steps which will be taken to avoid further violations; and (5) the date when full compliance will be achieved.
Where good cause is shown, consideration will be given to extending this response time.
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