ML20211K197
| ML20211K197 | |
| Person / Time | |
|---|---|
| Issue date: | 06/19/1986 |
| From: | Grimsley D NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Hodgdon A AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20211K202 | List: |
| References | |
| FOIA-86-403 NUDOCS 8606270348 | |
| Download: ML20211K197 (2) | |
Text
"' D UNITED STATES
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NUCLEAR REGULATORY COMMISSION W ASHINGTON, D. C. 20555 g
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JUN 19 306-Mr. Andrew D. Hodgdon 584 Grove Street IN RESPONSE REFER Newton, MA 02162 TO FOIA-86-403
Dear Mr. Hodgdon:
This is in regard to your request, pursuant to the Freedom of information Act, to which the NRC assigned the above number.
This is a partial response to your request.
We will notify you upon completion of search for and review of any additional records subject to your request.
_X__
The staff has completed the search for and review of records subject to your request, and this is the final response to your request.
The NRC has no records subject to your request.
Records subject to your request are available for public inspection and copying at the NRC Public Document Room (PDR), 1717 H Street, NW, Washington, DC 20555, as noted on the enclosure (s).
The PDR accession number is identified beside each record description.
_Z__
Records subject to your request are being made available for public inspection and copying at the NRC Public Document Room (PDR), 1717 H Street, NW, Washington, DC 20555, in the PDR file folder under the above number and your name.
These records are listed on the enclosure (s).
We are enclosing a notice that provides information about charges and procedures for obtaining records from the PDR.
Sincerely, Donnie H. Grimsley, Director Division of Rules and Records Office of Administration Enclosure (s):
As stated l
l 8606070348 860619 i
HODODONG6-403 PDR
i Appendix F01A-86-403 l
t DATE ORIGINATOR RECIPIENT DESCRIPTION 1.
3/28/86 NRC Harvard University CAL No. 86-06 (3pgs.)
2.
4/21/86 NRC Harvard University Combined Inspection (19 pgs.)
Nos. 30-00753/86-01; 30-10180/86-01 and 30-15244/86-01.
3.
4/21/86 NRC Distribution List Notice of significant licensee (1 P9-)'
Meeting No.86-052.
4.
4/2 /86 Harvard NRC Acknowledgment of receipt (1 P9-)
University of 4/21/86 letter and confirmation of attendance at enforcement conference.
University dated 3/28/86 5.
5/22/86 NRC Harvard University Enforcement Conference Report (5pgs.)
No. 30-00753/86-02.
d 6*
6/9/86 NRC Harvard University Notice of violation and (8 pgs.)
r proposed imposition of civil penalties (NRC combined Inspection Report Nos. 30-00753/86-01; 30-10180/86-01; and30-15244/86-01).
7-6/10/86 Office Press Release press Release No. I-86-76. (1 pg.)
of Public Distribution Af fa i rs,
Region 1 8.
4/25/86 Harvard Univ. NRC Ltr concerning corrective actions and results of audit (19 pgs.)
=~
).b Docket Nos. 030-00753 License Nos. 20-00297-53 030-10180 20-00297-58 030-15244 20-00297-59 CAL No. 86-06 Harvard University ATTN: Warren E. C. Wacker, M.D.
Director of University Health Services 75 Mount Auburn Street Cambridge, Massachusetts 02138 Gentlemen:
This refers to the discussions of our findings at the conclusion of Inspection No. 86-01 between yourself and Dr. John E. Glenn of my staff on March 27, 1986.
During those discussions, Dr. Glenn expressed our concern over the seriousness of certain of the violations identified.
From those discussions, and from the telephone discussions between Mr. Robert Johnson, Harvard University, and Mr. James H. Joyner of this office on March 28, 1986, we understand that you have taken or will take the following actions:
1.
All disposals of radioactive material by incineration, burial, or decay followed by disposal in the normal trash will be halted until a complete audit of your waste handling program is completed.
In this regard, we understand further that; a.
Detailed procedures will be developed for handling and conducting adequate radiation surveys of radioactive waste, b.
Radioactive waste storage areas will be repaired as necessary to provide a dry storage environment.
c.
A radiation survey of each container of packaged radioactive waste will be conducted.
d.
Labelling of each container of packaged radioactive waste will be checked for accuracy.
e.
Radioactive waste in damaged containers will be repackaged.
f.
Drums in the older radioactive waste storage building will be restacked in a safe manner.
g.
The results of your audit and your corrective actions will be reported to this office in writing no later than 30 days 'from the date of this letter.
2.
The Radiation Safety Committee will meet within seven days of March 27, k
1986, to discuss the findings of Inspection No. 86-01. Further:
OFFICIAL RECORD COPY CAL HARVARD U - 0001.0.0 11/29/80 I
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Harvard Univzrsity 2
a.
The Radiation Safety Committee will determine what action is needed to secure correction of the problems identified in the four labora-tories whose authorizations to use radioactive material were suspended on March 27, 1986.
b.
The Radiation Safety Committee will reaffinn its policy for repeat violations and will communicate this policy to all authorized users.
c.
The Radiation Safety Committee's actions with regard to the four laboratories whose authorizations were suspended will be reported by telephone to Dr. Glenn (215 337-5260) prior to lifting the suspen-sions.
3.
A bioassay will be performed on the individual believed to have mouth-pipetted solutions containing radioactive materials, and the results reported to this office in writing within ten days after the results become available.
If our understanding of your planned actions, as described above, is not in accordance with the actions being implemented, please contact this office by telephor.e and in writing within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of your receipt of this letter.
Sincerely, Thomas T. Martin, Director Division of Radiation Safety and Safeguards cc:
Robert Johnson Assistant Radiation Safety Officer 46 0xford Street Cambridge, Massachusetts 02135 George Weinert, Deputy Director Environmental Health and Safety 46 0xford Street Cambridge, Massachusetts 02135 t
PublicDocumentRoom(PDR)
Nuclear Safety Information Center (NSIC)
Commonwealth of Massachusetts (2) 0FFICIAL RECORD COPY CAL HARVARD U - 0001.1.0 11/29/80
a Harvard University 3
bcc:
Region I Docket Room (w/ concurrences)
J. Allan, RI J. Gutierrez', RI D. Holody, RI T. Martin, RI J. Glenn, RI J. Joyner, RI E. Flack, IE V. Miller, NMSS J. Johansen, RI J. Jensen, RI J. Miller, RI i
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1 Friedman JGlenn JJoyner artin Al n
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0FFICIAL RECORD COPY CAL RVARD U - 0002.0.0 11/29/80
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APR 21 EE6 Docket Nos.;030-00753 License Nos. 20-00297-53 20-00297-58 030-10180 20-00297-59 030-15244 Harvard University ATTN: Robert Scott Vice President Radiation Protection Office 46 0xford Street Cambridge, Massachusetts 02138 Gentlemen:
Subject:
Combined Inspection Nos. 030-00753/86-01; 030-10180/86-01, and 030-15244/86-01 This refers to the routine safety inspection conducted by Ms. Jenny Johansen, Mr. John Miller and Mr. John Jensen of this office on March 25-27, 1986 at your facilities in Cambridge, Boston and Southborough, Massachusetts of activities e
authorized by NRC License Nos. 20-00297-53; 20-00297-58 and 20-00297-59 and to the discussions of our findings held by Ms. Johansen, Mr. Miller,and Dr. John E. Glenn of this office with Dr. Wacker, Mr. Robert Johnson, Mr. Ray White, and Mr. Frank Osborne of your staff at the conclusion of the inspection, and to a subsequent telephone discussion between yourself and Mr. James Joyner of this office on April 18, 1986.
As discussed during the telephone conversation between yourse and Mr. Joyner, the apparent violations identified during this inspection will be discussed at an Enforcement Conference at our office in King of Prussia, Pennsylvania at 1:30 p.m. on May 1, 1986. We understand that you will attend this meeting with other members of the University staff.
You should be prepared to discuss the causes of these apparent violations and your proposed corrective action.
Enforcement action for these violations will be considered by the NRC 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.
j In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter will be placed in the Public Document Room.
No response to this letter is required.
Md SU RETumi ORIGINAL TO REGION I OFFICIAL RECORD COPY IR HARVARD U - 0001.0.0 l
04/18/86
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i
Harvard University 2
Apg 31 g Your cooperation with us in this matter is appreciated.
Sincerely, Original Signed By John E. Glenn Thomas T. Martin, Director Division of Radiation Safety and Safeguards
Enclosures:
1.
NRC Region I Combined Inspection Report Nos. 030-00753/86-01, 030-10180/86-01 and 030-15244/86-01 2.
10 CFR Part 2 cc w/ encl:
Public Document Room (POR)
Nuclear Safety Information Center (NSIC)
Commonwealth of Massachusetts (2)
Mr. George Weinert, Deputy Director Environmental Health and Safety 46 0xford Street Cambridge, Massachusetts 02138 Dr. Jacob Shapiro Radiation Safety Officer 3
46 0xford Street Cambridge, Massachusetts 02138 bcc w/ encl:
Region I Docket Room (w/ concurrences)
Management Assistant, ORMA (w/o encl)
J. Axelrad, IE J. Lieberman, ELO E. Flack, IE J. Allan D. Holody J. Johansen J. Miller J. Jensen J. Glenn J. Gutierrez T. Martin RI:0RSS RI:0RSS RI:DRSS RI:DRSSpuRI:DRSSqoRI:0RSS Glenn QMartin 4/ive864(JJoyner4e>.//8fgr 4ee.
Mil er Jensen Johanseg/bc 4,u/86 4/i <8 4/i<<8e 0FFICIAL RECORD @PY -
IW HARVARD U - 0002.0.0 04/18/86
i U.S. NUCLEAR REGULATORY COMMISSION REGION I i
Report Nos.
030-00753/86-01 030-10180/86-01 030-15244/86-01 Docket Nos.
030-00753 030-10180 030-15244 License Nos.
20-00297-53 Priority II Category FIA 20-00297-58 20-00297-59 Licensee:
Harvard University Radiation Protection Office 46 0xford Street Cambridge, Massachusetts 02138 Facility Name:
Harvard University Inspection At:
Cambridge, Boston, and Southborough, Massachusetts Inspection Conducted:
March 25 and 27, 1986 Inspectors:
Y- ' F' 74' pfini J a se ealth Physicist date Y fl v n J. Miller, Health Physicist date f Y / VL J n T. Jensen, Health Physicist date ~ Approve by: S/ 4 mm J @ E. Glenn, Ph.D., Chief date N(clear Materials Safety Section B Inspection Summary: Inspection conducted on March 25, 26, and 27, 1986 (Report No. 86-01) Areas Inspected: Rottine unannounced inspection of two irradiator licenses and an academic broadscope program which covers research and development, calibra-tion services for other institutions and waste disposal services for affiliated institutions including licensee action on previous inspection findings, organt-zation, training and instructions to employees, internal audits, materials, facilities and instruments, security, receipt and transfer of materials, p-ersonnel protection, radiation protection procedures, effluent controls and waste disposal, transportation, posting and tour of the facilities. 3
w 2 Results: Seventeen apparent violations were identified. Failure of the Radiation Safety Committee to. meet quarterly (Section 4); Failure to train (Section S); Failure to calibrate a survey meter annually (Section 7) Failure to maintain security over licensed materials, two examples (Section 8); Failure to refrain from mouth pipetting (Section 11); Failure to adequately survey prior to disposal in the normal trash (Section 11); Failure to refrain from eating, drinking and storing of food in laboratories (Section 11); Failure to evaluate sanitary sewer disposal (Section 11); Failure to evaluate extremity exposures (Section 11); Failure to decontaminate spills upon notice (Section 11); Failure to dispose of radioactive ash in an authorized manner (Section 12); Failure to placard truck for LSA shipments (Section 13); l Failure to prepare shipping papers (Section 13); Failure to mark fiberboard drums " Radioactive LSA" (Section 13); Failure to use strong, tight packaging (Section 13); Failure to block and brace materials in waste disposal truck s (Section 13) 4 l ---.w--- ,.~ -p- -n-a-n-
DETAILS i 1. Persons Contacted
- Warren E. C. Wacker, M.D., Directcr, Harvard University Health Services Jacob Shapiro, Ph.D., Radiation Protection Officer (RPO)
- Robert U. Johnson, Associate Radiation Safety Officer (RS0)
Mr. Ciaotti, Director of Biological Lab Building, Member of Radiation Safety Committee Mr. Lenhoff, Area Radiation Safety Officer, Biochemistry and Biology
- Mr. Ray White, Senior Safety Engineer, Administrative Manager, Environmental Health and Safety
- Mr. Frank Osborne, Senior Health Physicist Mr. Jeffrey Milner, Radiation Survey Technician Mr. Richard St. Louis, Radiation Survey Technician Custodian, Biochemistry Building, Cambridge Campus Dishwasher, Biochemistry Building, Cambridge Campus Various professional staff, researchers and graduate students Cambridge, Boston and Southborough facilities
- Present at Exit Interview 2.
Licensee Actions on Previous Inspection Findings (0 pen) Inspection 84-01: Failure to survey for radiation levels or con-tamination prior to disposing of materials in the normal trash. The licensee warned the investigators in the building involved and stated that this appeared to be an isolated event. The laboratory personnel were given retraining and monitoring, daily surveys of all nonradioactive trash were required r id the results documented. In additici, the Radiation Protection Office technicians were instruction to increase monitoring of unmarked bags in hallways. From our March,1986 inspection it appears that the licensee's corrective actions should have been reviewed University-wide, as the same violation was identified in another area. (See Section 11) (Closed) Inspection 84-01: Failure to survey to assure radiation levels in the unrestricted area did not exceed 2 mrem in any one hour. The inspectors performed surveys in the unrestricted areas of the facilities visited. In no case were radiation levels so that a dose in excess of 2 mrem in any one hour would occur. (Closed) Inspection 84-01: Failure to post " Caution Radioactive Materials" signs. The inspectors observed all rooms were properly posted. (Closed) Failure to post Form NRC 3 in areas where it could be seen by individuals frequenting a restricted area. The inspectors observed that suf ficient Form NRC 3's were posted.
- = 4 ~ l 3. License Nos.: 20-00297-58,'20-00297-59 The inssiectors visited the self-contained irradiators that are authorized urider ifcense numbers 20-00297-58 and 20-00297-59. The records indicated that all of the irradiators had been leak tested at their required 6-month l frequency and all the leak tests yielded results less than 0.005 micro-Radiation levels measured by the inspectors in the unrestricted curies. 1 areas adjacent to the irradiators did not exceed levels specified in 10 CFR 20.105. The Gammacell 220 irradiator was serviced by AECL approximately one month i prior to the inspection. Personnel utilizing the irradiators were ade-j l quately trained. f 4. Organization The Radiation Protection Office has a staff which includes the Radiation Protection Officer (RPO), the Associate Radiation Safety Officer (RS0), l a.part-time Senior Health Physicist (only 10-15% of the time, as he is a named Radiation Safety Officer on two broad licenses of affiliated insti-tutions), a chief radiation survey techt.ician, five radiation survey tech-nicians, three waste disposal technicians, one full-time administrative aide and some part-time administrative personnel. The' adequacy of the i size of the staff was discussed during the exit interview (See Section 16). The Radiation Protection Office' staff also provides services to Harvard affiliated institutions in addition to the facilities composing Harvard University (See Attachment No.1 for list of facilities). According to the RS0's quarterly report for the period October 1 to December 31, 1985, which covers Harvard and its affiliated institutions, the survey technicians performed over 1800 surveys in over 1532 labora-tories involving over 3000 individual users (422 of whom were principal-investigators responsible for these laboratories). The Radiation Pro-j tection Office also provides effluent monitoring, thyroid monitoring, 1 incident response, personnel dosimetry, training and waste disposal for l Harvard University and its affiliated institutions. 1 The Radiation Safety Committee (RSC) consists of a representative of l Harvard University's administration, the Committee Chairman (who also is the Radiation Protection Officer (RPO)) the Associate Radiation Safety Officer (RS0), and representatives from the various departments using { radioactive materials. The RSC is responsible for assuring the safe use i ) of radioactive material and for promulgating internal controls over the use of radioactive materials. l An inspector reviewed the. minutes of the RSC'.s meetings for 1984 and 1985. The minutes indicated that the committee reviews, approves, or dentes all requests for new uses, renewal of previous authorizations and amendments of l existing authorizations. Reviews by the RSC' included the training and experience of the principal investigator, adequacy of facilities, instru-l mentation, and imposition of requirements. The RSC also approves j l l l l
5 auth'orization of individuals at affiliated institutions who have Harvard According to the RSO these authorizations are for the same mate-grants. He rials and quantities that the affiliated institutions have issued. coordinates the Harvard authorization with the affiliated institution'.s authorization. An inspector reviewed approximately 30 authorizations Each applicant had been reviewed for training, approved by the Committee. safety evaluations had been performed, and requirements imposed. The RSC met on January 31, June 26 and November 13 in 1984 and March 19, j July 2, and November 12 in 1985. The licensee's application dated February 23, 1979 contains a document entitled " Radiation Safety Committee" which states that the RSC meets quarterly. The finding that the RSC did not meet during the third quarter of 1984 and the second quarter of 1985 is an apparent violation of Condition 26 of License No. 20-00297-53. I 5. Training and Instructions to Employees i An inspector discussed with the RSO the training of ancillary personnel The (housekeeping, security, etc.) who may frequent a restricted area. I RSO stated that training for ancillary personnel had been given in the l Through records review and discussions with individuals past six months. the inspector determined that training had been given to ancillary per-sonnel. The licensee's application dated February 29, 1979 contains a document entitled " Radiation Safety Committee", which states, "No one is allowed to work with radioactive material without having had formal training..." 10 CFR 19.12 requires that all individuals working in restricted areas be i instructed in the applicable provisions of the Commission's regulations i and licenses. Through discussions with research personnel during the tour of the faci-lities and review of training and experience of the research personnel documented in the principal investigators' authorization files, the inspectors identified at least four individuals who worked with radio-active materials but had not attended a Harvard University formal training session prior to using radioactive materials. 4 The finding that individuals had not received Harvard University's formal training prior to the use of radioactive materials is an apparent violation of Condition 26 of License No. 20-00297-53 and 10 CFR 19.12. 6. Internal Audits The licensee does not have a. formal quarterly audit program which covers each principal investigator's laboratories, however, the RSO does make
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6 unannounced audits of laboratories with a frequency. depending on level of. The RSO stated that unannounced formal audits were performed when use. the radiation survey technician's monthly surveys identified repeated The RSO violations or problems in the high level of use laboratories. stated that he had performed formal audits of at least 15 principal investigator's laboratories in the past year and he had suspended some Additionally, the RSO stated authorizations as a result of the audits. that he had placed some principal investigators on notice that if further violations were found in their laboratories their authorization to use radioactive materials would be suspended. As a result of the NRC inspection findings, the RSO suspended authoriza-tions 02-06-GOL, 03-15-MUL, 02-10-GOL, AND 02-05-DEP on March 27, 1986. (See Section 16) No violations were identified. 7. Materials, Facilities and Instruments To control the quantities of materials authorized by the license, the license requires that authorized principal investigators submit an annual These inventory of each radionuclide possessed, usually as of April 1st. inventory results are compared to the amounts permitted on the authoriza-If the possession excteds the amount authorized, the principal tion. investigator.is notified that the excess material must either be disposed Additionally each purchase of one milli-of or the authorization amended. curie or more must be cleared through the Radiation Protection Office. Purchasing will not process these orders without the RSO's specific approval. In addition, the RSO receives a copy of all purchase orders for radioactive materials. An inspector reviewed the 1984 and 1985 annual inventories and found the materials on hand did not exceed the limits stated in License No. 20-00297-53. The license has approximately 16 buildings in the Harvard Medical Area and approximately 15 buildings at the Cambridge Campus in which licensed materials are used, in addition to the Southborough labs and waste hand-ling facilities. The inspectors toured a selected number of these buildings during the inspection. The facilities agreed with the state-ments in the licensee's application and supporting documents. All restricted areas were found to be properly posted. No violations were identified. The licensee has a large number of survey _ instruments available for the Radiation Protection Office staff. In addition,'certain principal-investi-gators are required by their authorizations to have an operable, cali-brated survey meter or monitor for surface contamination.
,~ b e 7 The licensee requires that survey meters or monitors be calibrated yearly in accordance with the procedures outlined in a letter dated December 12, 1985. During the tour of facilities, the inspectors identified an Eberline E120 survey meter, Serial No. 7299, in Building 8, Lab 354, at the Harvard Medical School which had not been calibrated since September 12, 1983. This survey meter was required to be calibrated annually. The finding that as of March 27, 1986 a survey meter had not been calibrated since September 12, 1983, a period of time in excess of one year, is an apparent violation of Condition 26 of License No. 20-00297-53. 8. Security On March 27, 1986, an inspector accompanied by a licensee representative toured selected buildings at the Cambridge campus. In the Biochemistry Building, the inspector observed that in the majority of laboratories visited and posted with " Caution Radioactive Materials" signs, and in which radioactive materials were stored, had open, unlocked doors and no one was present in the laboratories to maintain constant surveillance or immediate control over the licensed material in the laboratories. From discussions with a dishwasher and the building custodian the inspector determined that the doors of these laboratory rooms were open when the two individuals, arrived that morning, The finding that licensed materials stored in unlocked laboratories were c neither secured from unauthorized removal from the place of storage nor under the constant surveillance and immediate control of the licensee is an apparent violation of 10 CFR 20.207. While visiting a storage facility for radioactive waste held for decay-in-storage, the inspectors identified some fiberboard barrels containing radioactive material in a dumpster adjacent to the building. Radiation levels on contact with the two barrels were measured at 200,000 cpm, and 10,000 cpm, respectively by the inspectors with a thin crystal sodium-iodide detector (Ludlum Model 16, NRC No. 000885). Both of the barrels had been surveyed by technicians and released for disposal in the normal trash. The RSO stated that the barrels had not been released for ultimate disposal because they had not been surveyed by the Radiation Protection Officer. The dumpster where the barrels were stored was in an unrestricted area and was not maintained under constant surveillance and immediate control of the licensee. The finding that the licensee failed to secure licensed material stored in an unrestricted area or to maintain constant surveillance and immediate control of that material is an apparent violation of 10 CFR 20.207.
8 9. Receipt and Transfer of Materials The[RSOreceivescopiesofallpurchaseordersforradioactivematerials and'must approve all orders for one millicurie or more. Section 8 of the licensee's " Regulations for Use of Radioisotopes..." require that an indi-vidual authorized to use radioisotopes must sign for receipt of packages containing licensed materials. Upon receipt, the packages must be examined and wipe tests for removable contamination on the package surface and inside container must be performed. The results of the wipe tests must be documented on a receipt form and forwarded to the Radiation Protection Office. In addition, dose rate at the package surface must be measured prior to opening the package for those packages containing nuclides with surface dose rates. The results of these measurements are not recorded on the receipt form. Radioactive materials packages are delivered to each building's receiving dock. Receiving dock personnel notify the user's laboratory that the package has arrived and a user picks up the package and returns with it to the laboratory to perform the required surveys. An inspector reviewed all copies of purchase orders and corresponding receipt forms of packages received since January 1, 1986. All packages received were surveyed as required. No violations were identified. 10. Personnel Protection The licensee has an "in-house" film badge and TLD ring program. The licensee has participated in the NAVLAP program, however, the RPO stated that, because of the burden of approximately = 3000 dosimeters monthly, the in-house program was being terminated. The licensee will, in the near future, obtain personnel dosimetry from a commercial vendor. The licensee currently supplies monthly whole body film badges to all users of radioactive material, except those using tritium exclusively. Individuals using millicurie levels of P-32 are supplied with TLD ring badges. An inspector reviewed the RS0's quarterly reports and determined all exposures for 1984 and 1985 were well below the limits stated in 10 CFR 20.101. .The licensee requires thyroid monitoring within one month of using 0.1 millicurie of iodine-125 or iodine-131 for an todination unless a per-sonnel air monitor indicates a potential uptake. The.RSO then, requires a thyroid scan within 14 days. An inspector reviewed the thyroid monitoring results for 1984 and 1985. In particular, the results of thyroid scans for four individuals identi-fied by the inspectors of an iodination facility at Harvard Medical School i
3 9 as having performed fodinations during January, February and March 1986. The inspector found that these individuals did have thyroid monitoring performed at the required frequency or that thyroid monitoring (March., iodinations) would be performed within the one-month requirement. The RSO stated that he reviewed all orders for iodine-125 or iodine-131 and noted the receipt report for these orders. He then allowed 20 days to elapse prior to calling the laboratory to check on why individuals from the lab had not appeared for thyroid monitoring. In addition, the use logs of the 16 iodination facilities were checked monthly by the radiation survey technicians to see who had performed iodinations. Results of thyroid monitoring showed no one at Harvard had exceeded 20% of the MPC for iodine-125 or iodine-131 in the thyroid. Urine samples for those handling 100 mci of tritiated water or 10 mci of a tritiated organic compound are requiredby the licensee's " Regulations for Use of Radioisotopes...." An inspector reviewed the results of urine bioassays for 1984 and 1985. No individual exceeded 10% of an MPC for tritium in the urine. The licensee requires that individuals survey their hands, feet and clothing for contamination prior to leaving radioactive materials work areas. The inspectors touring the laboratories performed independent surveys of the hands, feet and clothing of individuals working with phosphorus-32 or iodine-125. No contamination was detected. No violations were identified.
- 11. Radiation Protection Procedures The inspectors reviewed the licensee's procedures for protection of personnel, facilities and the environment.
(See Sections 5,6,7,8,9,10, 12,14,and 15) The inspectors reviewed the licensee's compliance with 10 CFR 19 and 20 through observations and discuss-ions with individuals during the tour of the facilities. On March 27, 1986 the inspector touring the Biochemistry Building found evidence of mouth pipetting in laboratories posted with " Caution Radio-active Materials" signs. The inspector discussed mouth pipetting of radioactive materials with a researcher in Room 241. The individual admittea he did pipette radioactive materials by mouth. The licensee's representative accompanying the inspector stated that he had observed the individual pipetting radioactive materials by mouth during the last survey of the laboratory and had told the individual that mouth pipetting was not allowed. On that occasion, the individual had continued to pipette by mouth in the technician's presence.
10 The finding that an individual stated that he pipetted radioactive materials by mouth is an apparent violation of procedures referenced in Condition 26 of License No. 20-00297-53. The inspector was also informed by individuals in Room 237 that they ~ pipetted bacterial solutions by mouth, but did not pipette radioactive materials by mouth. The inspector discussed this information with the Senior Safety Engineer. 10 CFR 20.201(b) requires that each licensee make such surveys as may be As defined in 10 CFR necessary to comply with all sections of Part 20. 20.201(a), ". survey" means an evaluation of the radiation hazards incident to the production, use, release, disposal, or presence of radioactive materials or other sources of radiation under a specific set of conditions. 10 CFR 20.301 requires that no licensee dispose of licensed material except by certain specified procedures. The inspector found bags of " normal" trash in the hallway on the 2nd ficor of the Biochemistry building near Room 221. The inspector observed that the bags had no labels indicating that the bags contained radioactive The inspector surveyed the bags with an Eberline E120 survey wastes. meter and found radiation levels of 0.2 to 0.5 mR/hr from one of the bags. The inspector requested that the two researchers in Room 221 survey the contents of the bags and remove the radioactive materials. The Building Custodian stated that he could not determine the laboratory fron. which the trash had been removed, as he had collected all the " normal" teash from the laboratories on the 2nd floor that morning. The finding that no surveys were not made to assure compliance with 10 CFR 20.301 which describes authorized means of disposing of licensed material is an apparent violation of 10 CFR 20.201(b). This is a repeat of a similar violation identified during Inspection 84-01. The inspectors toured a number of laboratories in the Medical School Complex of Harvard University in Boston. The inspectors observed three instances of drinking in laboratories where radioactive materials are used, and two instances of storage of food and drink in laboratories where radioactive materials were used. The inspectors observed a laboratory technician in laboratory 263 in Building C2, where millicurie quantities of hydrogen-3 and phosphorus-32 were used, consume a cup of coffec after the inspector informed the technician of the hazard associated with this practice and that the practice was a violation of the University's regulations..The technician stated that the principal inves-tigator of the laboratory recommended that food and drink not be consumed in the laboratory. The technician added that drinking in the laboratory is lef t to the personal preference of the laboratory personnel and that there is no formal prohibition against the practice. The inspectors also observed a technician drinking in a laboratory in the Seely-Mudd Building,
1 i 11 I i where millicurie quantities of hydrogen-3 and sulfur-35 were used. In addition, the inspectors were informed by a. technician that she had drank i coffee in laboratory 270 in Building C2 where millicurie quantities of i l hydrogen-3, phosphorus-32 and sulfur-35 are used. The inspectors observed a refrigerator used for the sole purpose of storing food and drink in 4 laboratory 412 of the Seely-Mudd Building where approximately 250 micro-curies of phosphorus-32 were used. The inspectors also observed food stored in a refrigerator in laboratory 314 of the Seely-Mudd Building where approximately 100 microcuries of phosphorus-32 and iodine-125 were used. j The finding that drinking and storing of food and drink occurred in i laboratories where radioactive materials are used and stored is an apparent violation of Condition of 26 License No. 20-00297-53. 1 The inspectors observed five instances of disposal of radioactive material to the sanitary sewerage system for which the licensee made no evaluation i j to insure that releases were within 10 CFR part 20 limits. The inspectors measured approximately 5 milliress per hour at a drain in a waste storage j room (room 804, Building B1) in which millicurie quantities of phosphorus-32 i and sulfur-35 were stored. The licensee was unable to determine who had disposed the material and when the disposal occurred. The inspectors measured approximately 500 counts per minute of low energy gamma radia-j tion at a drain adjacent to a hood in which radioiodinations are performed l with iodine-125 (laboratory 124, building C2.) The laboratory personnel were unaware of disposals in this drain and had not recorded these dis-t l posals. The, inspectors measured similar levels of low energy gamma radia-tion at drains in laboratories 267, 417 and 908 of buildings C2, 81 and ] B1, respectively, of'which laboratory personnel were unaware of disposals i to those drains. l l The finding that the licensee failed to evaluate disposals of radioactive material to the sanitary sewerage system is an apparent violation of 10 CFR 20.201(b). l The inspectors were informed that a technician performed an experiment in {' laboratory 908, Building B1, using approximately 5 millicuries of phosphorus-32 and was not issued, and did not wear, any dosimetry to evaluate the exposure to the extremities of the technician. 4 The finding that the licensee failed to evaluate the exposure to the extremities of a technician that used approximately 5 millicuries of phosphorus-32 is an apparent violation of'10 CFR 20.201(b). f On March 25, 1986 at approximately 3:30 p.m., the inspectors discovered, on the floor of a waste storage room (room 8048, Building B1), removable contamination, some of which became affixed to the soles of the inspectors' shoes, as well as those of the Itcensee representative. The inspectors and the licensee representative decontaminated the soles of their shoes, which read as high as one millirem per hour. The inspectors then deter-mined (through wipe tests analyzed by the licensee's liquid scintillation 1 1
12 counting system) that removable contamination existed on the floor outside of the waste storage room in room 804, an unrestricted area. The levels of removable contamination in room 804 ranged from 4155 counts per minute per 100 square centimeters to 6743 counts per minute per 100 square centi-The inspectors recommended that the licensee contact the meters. Radiation Protection Office to assist in a thorough evaluation of the The extent of the contamination and assist in the decontamination effort. inspectors lef t the area upon the arrival of a representative of the Radiation Protection Office staff. The inspectors returned to room 804, Building B1, on March 26, 1986 at The inspectors determined (through wipe tests approximately 8:30 a.m.. and analysis by the licensee's liquid scintillation counting system) that removable contamination existed in room 804 and in the corridor adjacent to the entrance to room 804. The levels of removable contamination in the corridor ranged from 1582 to 1758 counts per minute per 100 square centi-meters, and the levels in room 804 ranged from 1320 to 7461 counts per minute per 100 square centimeters. The inspectors observed that neither the area in the corridor adjacent to room 804 or the room itself had been restricted for purpose of protection from radiation hazards. The licensee representative had informed the inspectors that she had initiated a decon-tamination effort on the previous afternoon and that a direct reading survey had been performed, but that a removable contamination survey had not been performed. The licensee's radiation protection procedures require that all spills of radioactive material be cleaned up promptly and that a survey be made after cleaning to verify that the radioactive material has been removed. The finding that the licensee failed to promptly decontaminate an area affected by a spill of radioactive material and to perform an adequate survey to verify that the radioactive material has been removed is an apparent violation of Condition 26 of License No. 20-00297-53.
- 12. Effluent Controls / Waste Disposal a.
Effluent Controls The licensee monitors effluent releases of 16 iodination hoods. An inspector reviewed the records for effluent releases for 1984, 1985, and 1986. The releases for 1984, 1985 and 1986 were well below 10% of the maximum permissible concentration (MPC) for unrestricted areas (environmental) as stated in 10 CFR 20.106 and averaged over a period not exceeding one year. No violations were identified. b. Waste Disposal The licensee disposes of radioactive wastes through decay-in-storage, incineraticn, on-site burial at Southborough, a commercial broker for waste burial in the State of Washington, and a hazardous waste
e 13 broker in accordance with 10 CFR 20.306. Since July 1984, records indicated that'the licensee has performed approximately 20'incinera-tions involving 725 fiberboard drums of waste, the majority of the nuclides involved being hydrogen-3, carbon-14,' sulfur-35 or todine-125, i has performed two burial involving 69 drums of short-lived nuclides; has sent 1,257 tiarrels to a hazardous waste broker in accordance with 10 CFR 20.306; has placed 2,060 barrels in storage for decay; and ~ shipped 851 barrels of waste through a commercial broker for burial in the State of Washington. An inspector reviewed the licensee's records for stack monitoring as a result of incineration performed from July 1984 to March of 1986. These records indicated that releases did not exceed 20% of MPC for all nuclides incinerated. An inspector reviewed the shipment manifests for the last 5 shipments of waste through the licensed waste broker for burial in Washington. The inspector noted that the January 27, 1986 shipment was returned, as one barrel contained an unacceptable isotope. All other manifests indicated that the barrels contained Class A waste and were prepared according to 10 CFR 61.55, 61.56, and 10 CFR 20.311. The licensee had a copy of the manifests and documentation of acknowledgement of receipt for all shipments since the last NRC inspection on January 26, 1984. The inspector noted that the last 5 shipment manifests contained barrels of waste from Harvard affiliated institutions, rather than a t separate manifest from each institution. The RSO stated that the licensee had discussed this with the broker and, in future' shipments, manifests will be made for each institution's waste. On March 27, 1986, the inspectors visited the two facilities where the licensee held radioactive waste for decay-in-storage. Fiberboard drums were often piled four high. In one of the facilities, a severe water leak had occurred and flooded the floor of the facility. Some of the fiberboard drums had absorbed the water on the floor and were buckling under the weight of the drums stacked on top of them. The integrity of these barrels was questionable. On March 27, 1986, the inspectors visited the plot of ground at South-borough that is used for land burial of byproduct material. The area was fenced and posted with a " Caution - Radioactive Material" sign. j A survey was performed in the burial ground by the inspectors with a thin crystal sodium iodide detector (Ludlum Model 16, NRC No. 000885). A pile of ash, approximately 4 feet x 4 feet x'10 feet, was determined to cor.tain radioactive material. Two localized spots in the ash pile emitted radiation fields above background, the larger of the two j measuring ~450,000 counts per minute with the scinttilation detector. 10 CFR 20.301 requires that no licensee dispose of Itcensed material j except by certain specified procedures. 1 b
i 14 t j The finding that the licensee disposed of radioactive material on the surface of the ground at the burial site is a method of disposal not authorized by the NRC and is an apparent violation of 10 CFR 20.301. i
- 13. Transportation Two The inspectors reviewed the licensee's transportation activities.
technicians who were responsible for collecting and transporting radioactive waste from Harvard and its affiliates to the Southborough The technicians storage facility were interviewed by the inspectors. stated that the majority of radioactive waste that was transported by Harvard University was categorized as low specific activity (LSA) and was i transported in fiberboard drums. They added that the fiberboard drums were labeled with the isotope and the words " Radioactive LSA" and no i i additional markings. The inspectors asked the technicians if the packaged shipments of LSA material were consigned as exclusive use. The technicians stated that the i shipments of LSA material were transported as " exclusive use". Later in I the inspection, the RSO confirmed that the LSA material was shipped as " exclusive use" and that the fiberboard drums used to ship the LSA mate-rial were " strong tight" containers and had not been tested to insure they met 00T specification 7A. n The inspectors asked the technicians if they placarded the vehicle when i they shipped the LSA material. They stated that they believed the vehicle required placarding, but they had been directed not to placard the l transporting vehicle by the RPO on the basis of out-of-date regulations. l The inspectors asked the RSO if the vehicle carrying the exclusive use shipments of LSA material was placarded, and he confirmed that it was not. He stated that the Radiation Safety Committee had discussed this parti- 'j cular issue at one of their meetings, but it was decided that the vehicle did not require placarding. LSA material was transported to Southborough, and the vehicle was not placarded, on March 12,13,19,22, and 26, 1986. j 49 CFR 173.425(b)(7) requires that the transport vehicle used for shipments of LSA material consigncd as exclusive use be placarded, with the placards prescribed in accordance with Subpart F of Part 172. The finding that the licensee failed to placard the transporting vehicle carry an " exclusive use" shipment of LSA material is an apparent violation of 49 CFR 173.425(b)(7). i The inspectors asked the technicians about.a shipment of radioactive waste that was transported from the Forsyth Dental Center to the Harvard Medical r School Complex on March 18, 1986. The shipment was comprised of four garbage pails, without fasteners for the lids, one of which contained 500 i microcuries of calcium-45. The inspectors asked the technicians if that I particular shipment form Forsyth Dental Center was accompanied by a ship-I ping paper. The technician who transported the radioactive waste from Forsyth stated that he did have a shipping paper in his possession while !} i e
l i ~ 15 I i 1 transporting the shipment. The RSO confirmed later that there the was.no shipping paper for the shipment from Forsyth Oental Center. ) 49 CFR 172.200(a) requires that a licensee who offers a hazardous material j for transportation must describe the hazardous material on the shipping ~ l paper in the manner described in 49 CFR 172. The finding that the licensee failed to describe on a shipping paper a hazardous material offered for transportation is an apparent violation of 49 CFR 172.200(a). During the inspectors' visit to the Harvard waste storage area at South-borough, Massachusetts, the inspectors identified approximately 15 fiber j board drums that were not labeled as " Radioactive LSA". Previously, the l technicians had informed the irspectors that the barrels of waste at j Southborough were labeled exactly as _they were shipped. 4 l l 49 CFR 173.425(b) (8) requires that packaged shipments of LSA material consigned as exclusive use must be stenciled or otherwise marked " Radio-1 active - LSA" on the exterior of each package. The finding that the licensee failed to stencil or mark " Radioactive-LSA" on each package of LSA material transported as an exclusive use shipment is.an apparent violation of 49 CFR 173.425(b)(8). On March 27, 1986, a technician drove a vehicle carrying 10-20 plastic j bags and containers of radioactive waste into the parking lot adjacent to the Environmental Health of Safety Office. Upon opening the back of the truck, the inspectors noted that the plastic bags and containers were not secured. } ) 49 CFR 177.834(a) requires that packaging not permanently attached to the motor vehicle and containing radioactive material must be secured against i t movement within the vehicle on which it is being transported under condi-I tions normally incident to transportation. h 49 CFR 173.425(b)(1) requiers that shipments of LSA material consigned as j exclusive use must be packaged in strong, tight packages:so that there i will be no leakage of radioactive material under conditions normally incident to transportation. i The finding that the licensee failed to secure packages containing radio-active material to prevent movement within the vehicle under conditions normally incident to transportation is an apparent violation of 49 CFR i 177.834(a). The finding that the 1icensee used plastic bags and garbage pails, packages 1 that are not strong and tight, to package LSA material for transport is an j . apparent violation of 49 CFR 173.425(b)(1). i i l t
o 9 16 14. Posting l All areas visited durinq the inspection were properly, posted.
- 15. Tour of Facilities On March 27, 1986 an inspector toured the Biochemistry and the Biological Sciences buildings at the Cambridge Campus and found apparent violations involving security (See Section 8); mouth pipetting; failure to perform a survey to assure that radioactive materials were not disposed in the normal trash (see Section 11).
On March 25,26, and 27, 1986 two inspectors toured the School of Public Health Building, the School of Medicine Buildings, the Laboratory for Reproductive and Reproduction Biology, the Seely-Mudd Building, the Harvard Medical Area receiving dock and waste disposal facilities, the laboratories of the Primate Center and the Southborough waste disposal fact,ities and found apparent violations involving drinking and storing food and drink in laboratories, evaluation of sanitary sewer disposal, evaluation of extremity exposure, and failure to decontaminate and perform adequate surveys for decontamination (see Section 11), unauthorized waste disposal (see Section 12), security (see Section 8) and transportation (see Section 13). 16. Exit Interview The inspectors reviewed the scope of the inspection and the findings with the individuals indicated in Section 1. Due to the seriousness of the violations identified, Dr. John E. Glenn, Chief Nuclear Materials Safety Section B, attended the exit interview and requested, and obtained, the licensee's commitment to take certain immediate corrective actions con-cerning the suspended authorizations and operations at the waste disposal facility (see Sections 6 and 12) and to report the results to Region I. The licensee's commitments were subsequently documented in a Confirmatory Action Letter issued by NRC Region I on March 28, 1986. Further, Dr. Glenn recommended that the licensee review the staffing of the Radiation Pro-tection Office at the professional level as it appeared that the licensee needed one if not two additional health physicists tu supervise the tech-nical staff to assure that commitments made to the NRC were properly carried out. Dr. Glenn reviewed the NRC's enforcement options as stated in Appendix C of 10 CFR Part 2.
SUBMIinM9 BY: R5b78EU. JXso, a o
- 30. 1984 July 1, 1984 to S:ptember ATTACHMENT 1
% OF TOTAL % CHANGE ry NUMBER OF PERSONS ON PROGRAM .PARTMENT EDICAL SCHOOL COMPLEX 357 .trv rd Medical School chool cf Public Health 146 26 Ichool of Dental Medicine 18 W R distion Laboratory 91 22.6 -0.2 ocolcy Mudd Building 14 652 'hapning Lab. LCHOOL OF ARTS & SCIENCE _S 137 ti:1:gy 26 homictry 'hycico-(includes Cyclotron) 15 16 kiCZ Ricchraistry 148 07 Ob:;rvetory 12.6 0 niv. cf Applied Science 13 364 02 POcbrdy Museum stOSPITALS Mass. Csneral Hospital (S.B.I.) 532 (58) 240 i:hildrcn's Hospital 257 PctGr Bent Brigham 92th Icrael Hospital 172 05 Rosten City Vatsrcn's Administration 23 24 1628 !! clean 11 rculknar 56.4 40.6 flaco. Rehabilitation 06 ~ 296 0FCI
- tt. Auburn Hospital 04
'tISCELLANEOUS 34 Bosten Biomedical Lab. 22 R; tin 5 Foundation 12 E. K;nnedy Shriver Res. Ctr. 03 'Ws3. Mental Health Ctr. 31 H.E. Regional Primate Res. Ctr. HetMMfescoueexanwvanecoxecoca.sxx 66 J;slin Clinic 16 Fctsyth Detttal Clinic 22 Haso. Eye & Ear Infirmary 01 8.1 -0.4 Haco. College of Pharmacy 28 235 0:ntGr for Blood Research HARVARD HEALTH SERVICES 0.3 0 05 09 Dental Clinic 04 X-rcy Department 2889 100.0 0.0 TOTALS .em.
April 21,1986 N2. 86-052 U.S. NUCLEAR REGULATORY COMilSSION REGION I NOTICE OF SIGNIFICANT LICENSEE MEETING Name of' Licensee: Harvard University Names of Facility: Harvard University Docket Nos.: 030-00753 030-10180 030-15244 Time and Date of Meeting: May 1, 1986, 1:30 p.m. Location of Meeting: NRC Region I, 631 Park Avenue, King of Prussia, Pennsylvania Main Conference Room Purpose of Meeting: Enforcement Conference regarding violations identified during Inspection No. 86-01 NRC Attendees: James M. Allan, Deputy Regional Administrator Thomas T. Martin, Director, Division of Radiation Safety and Safeguards James H. Joyner, Chief, Nuclear Materials Safety and Safeguards Branch, DRSS Jay M. Gutierrez, Regional Attorney Daniel J. Holody, Enforcement Specialist John E. Glenn, Chief, NMSS-B John T. Jensen, Health Physicist John J. Miller, Health Physicist Jenny M. Johansen, Health Physicist Licensee Attendees: Warren Wacker, M.D., Director, HUHS Ben Ferris, Director, Env. Health & Safeth George Weinert, Dep. Director, Env. Health & Safety Ann Taylor, Attorney Jacob Shapiro, RP0 Robert Johnson, RSO Note: Attendance by NRC personnel at this meeting should be made known by 4:45 p.m., April 30, 1986 via telephone call to J. Johansen, Region I, at FTS 8-488-1215. C'Li'A -jibC5 O ~ 1p$ Prepared 8 J. Johansen Distribution: d Victor Stello, Jr., Executive Director for Operationsy James H. Sniezek, Acting Deputy Executive Director for Regional Operations and Generic Requirements James M. Taylor, Director, Office of Inspection and Enforcement Jane Axelrad, Director, Enforcement Staff, IE J. Lieberman, Director and Chief Counsel, Regional Operations and Enforcement Division, OELD Don Chapell, Deputy Director, Division of Fuel Cycle and Material Safety, NMSS M I / Vandy Miller, Chief, Materials Licensing Branch, NMSS Leonard I. Cobb, Chief, Safeguards and Materials Program Branch, IE l public Document Room (PDR)}}