ML20027B600
| ML20027B600 | |
| Person / Time | |
|---|---|
| Issue date: | 05/24/1982 |
| From: | Haynes R NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | Roberts L NEW YORK, STATE OF |
| Shared Package | |
| ML20027B599 | List: |
| References | |
| NUDOCS 8209290006 | |
| Download: ML20027B600 (85) | |
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UNITED STATES Ref:
SA/RSH "g
NUCLEAR REGULATORY COMMISSION n
,I REGION I g
$31 PARK AVENUE KING OF PRUSSIA, PENNSYLVANIA 19406 MAY 241982 Ms. Lillian Roberts Industrial Comissioner New York State Department of Labor 2 World Trade Center New York, New York 10047
Dear Comissioner Roberts:
J This is to confinn the discussion Messrs. John McGrath and Ralph S.
Heyer held with Deputy Industrial Comissioner Edward Maher, Mr. Joseph Drayton and Dr. Francis Bradley on April 23, 1982, following the review and evaluation of the New York Capartment of Labor radiation control program. The review covered the pdncipal administrative and technical aspects of the program.
This included an examination of the program's legislation and regulations, organization, management and administration, personnel, and licensing and compliance functions.
Our review used as a reference, the " Guidelines for NRC Review of Agreement State Radiation Control Programs." These guidelines were published in the Federal Register on December 4,1981 as a final general statement of i
policy.
The Guide provides 30 Indicators for evaluating Agreement State program areas.
Guidance as to their relative importance to an Agreement l
State program is provided by categorizing the Indicators into two categories.
Category I Indicators reflect on a State's ability to adequately protect the public health and safety.
Category II Indicators are essential in order to avoid the development of problems in one or more of the principal programs areas, i.e., Category I Indicators.
When i
one significant Category I comment is mah, the deficiency may seriously affect the State's ability to protect th: ;ublic health and safety and the matter needs to be addressed on a priority basis.
If there are more than one significant Category I coments, then improvements in those areas are critically needed.
In such cases, we will need a timely response from the State and NRC staff recomendations for adequacy and compatibility will not be offered until after the response is received and evaluated.
In the latter case, a follow-up review would be made within six months.
8209290006 820914 PDR STPRQ ESGNY
Ms.'Lillian Roberts 4 Our review identified significant problems in two Category I Indicators i
as follows.
" Status of Regulations" recommends that the State have regulations essentially identical to 10 CFR Parts 19 and 20.
The last revision of Industrial Code Rule 38 was in 1978.
We recommended to Dr.
Bradley that the State begin updating these regulations to assure continued compatibility with NRC. The second Category I Indicator,
" Technical Quality of Licensing Actions" recommends that the radiation control program assure that all essential elements of applications have been submitted and meet current regulatory guidance.
Our review of selected license files identified the need for additional and/or more i
j detailed information in the application in several cases.
Suggestions were made to Dr. Bradley and staff to assure this information is received and evaluated prior to issuing the license.
1 i
Also discussed during our meeting were several topics concerning the general functions of the State's program. These included the addition of a word processor to aid the staff in the performance of their duties, the lower salary levels for professionals in comparison to other Agreement States and the consideration of adopting civil penalties as an additional method of enforcement by the Department.
Dr. Bradley indicated the possibility of the New York Department of Labor receiving license application (s) for uranium mills.
Additional requirements have been established by the Uranium Mill Tailings Radiation Control Act that Agreement States must meet if they wish to regulate i
l tailings associated with source material milling.
These must be met by New York and an amendment to the Section 274b Agreement between New York and NRC will be necessary. The process is complex.
If New York desires, we will be pleased to meet with you and other members of your staff to specifically review this matter in detail.
Enclosed are our specific comments on the technical and administrative aspects of the program. We would like to receive your response to the items mentioned above.
Dr. Bradley is welcome to respond to the canments contained in the enclosure including additional details on the Category I comments.
Enclosed is an extra copy of this letter for placement in your State Public Document Room or otherwise made available for public review.
l I
l ii~.-._______.-.._....__.-,._._.___..._.._____.,._..___._______._.._____-._____
Ms..Lillian Roberts,
I appreciate the courtesy and cooperation extended to Messrs. John McGrath and Ralph S. Heyer during the meeting with your staff.
Sincerely, f
e _=c 0 Q:1_
Ronald C. Hayn C Regional Administrator
Enclosures:
As stated cc:
Deputy Industrial Commissioner Edward Maher, w/ encl.
Dr. Frank J. Bradley, w/ enc 1.
Mr. Joseph Drayton, w/ encl.
Mr. Jack Spath, w/ encl.
Mr. G. Wayne Kerr, w/ encl.
State Public Document Room, w/ encl.
NRC Public Document Room, w/ encl.
Distribution:
EDO,w/ enc 1.
RCHaynes, Reg. I, w/ encl FBrenneman, Reg. I, w/ encl.
DANussbaumer,OSP,w/ encl.
JRMcGrath,OSP,w/ encl.
RSHeyer, Reg. IV, w/ enc 1.
State Letter Book, OSP, w/ encl.
OSP NY File, (file copy), w/ encl.
Reg. I NY File, w/ encl.
OSP Director's Reading File SA Reading File l
l
Technical Coments and Recomendations on the New York Department of Labor Radiation Control Pr m g I.
Legislation and Regulations l
" Status of Regulations" is a Category I Inc'icator.
The following significant deficiency was noted.
A.
Coment The State must have regulations essentially identical to 10 CFR Parts 19 and 20 and should adopt other regulations to maintain a high degree of uniformity with these of NRC.
A review of the New York Department of Labor Industr 1 Code Rule 38, " Ionizing Radiation Protection" indicated the last update, revision or amendment was on July 10, 1978.
Recomendation We strongly recomend that the State begin revising and updating Code 38 to include applicable changes made to NRC regulations since July 10, 1978 in order to maintain a high degree of uniformity. A chronology of these changes which have been incorporated into the Suggested State Regulations is enclosed (Enclosure 2).
We recomend that the Department begin to develop a long-term plan to revise and update Industrial Code Rule 38.
Due to the considerable staff effort that will be required, this plan should include benchmarks and provisions for progress reports to Department management.
II. Management and Administration
" Office Equipment and Support" is a Category II indicator.
The i
l following coment was noted.
A.
Coment and Recomendation Due to the increased number of applications for radioactive materials being submitted to the Department of Labor we.ecomend a word processor be obtained by the Department for the radiation control program. The word processor could also be used to store information relative to issuance of licenses as well as maintaining work load statistics related to license and compliance i
~.
actions.
If additional information is needed with respect to the types of infonnation retrieval systems used by other Agreement States, we would be pleased to assist you.
III. Personnel
" Staff Continuity" is a Category II indicator. The following coment and recomendation is made.
A.
Comment and Recomendation During past reviews it was stated that f;he professional salary levels were comparable to the other New York Offices and very competitive with the other Agreement State programs.
- However, it was noted during this review that there has been a steady decrease in the Department's standing in relation to other Agreement State programs.
This may become a problem in the future.
We recomend the staff salaries be monitored to assure that they remain competitive and do not become a factor adversely affecting the program's ability to attract and retain qualified staff.
IV.
Licensing
" Technical Quality of Licensing Actions" is a Category I Indicator.
The following significant deficiencies were noted.
A.
Coment Our review of selected license files indicates that, in at least two cases, applicants for new licenses were issued licenses without the submission of adequate operating and emergency procedures.
Recomendation We recomend that the applicants for new licenses and for license renewals submit operating and emergency procedures which reflect the scope of the applicants' activities and that licenses not be issued, or renewed, unless this information has been submitted.
B.
Coment and Recommendation Following each of the previous two program reviews we have comented on the need to renew licenses in their entirety at no greater than 5-6 years intervals.
We recommend that a license renewal action be based on complete, updated application and that all previous licensing documents be superseded.
As a minimum this policy should be established for Priority I licenses.
C.
Comment It was noted that in at least three license files cases, procedures for receipt of radioactive material were either not included in the license application or were not provided in sufficient detail.
Recommendation We recommend that detailed procedures be incorporated in the application to assure proper handling, storage and receipt of radioactive materials.
D.
Comment In our reyiew of selected license files, at least three renewal cases were identified where there was a need for submission of an updated health physics manual.
Recommendation It is recommended that health physics manuals be appropriately updated when licensees request renewal and especially to assure that any State and Federal regulations which are referenced in the manual are appropriately updated.
This is important in the case of Seismograph Service Corporation, license number 962-0278, which was recently renewed.
V.
Compliance
" Enforcement Procedures" is a Category I Indicator.
The following minor comment is noted:
A.
Comment Enforcement procedures should be sufficient to provide a substantial deterrent to licensee non-compliance with regulatory requirements.
During the meeting with Deputy Industrial Commissioner, we noted that adoption of civil penalties would provide an additional enforcement tool.
We would be pleased to respond to any comments or questions regarding civil penalties.
Attached, as Enclosure 3, is a copy of a February 1,1982 letter that was sent to Agreement States addressing the civil penalty issue and which invited State responses.
l
-4
" Inspection Reports" is a Category II Indicator and the following deficiencies were found:
B.
Comment Our review of selected compliance files indicated that worker interviews were not adequately documented and in some cases were apparently not conducted.
During the last review, this same comment was made. Upon discussions with the staff there were indications that inspectors now routinely interview workers, however, there was no supporting documentation.
Recommendation We recommend that once interviews are conducted with radiation workers, that the results of the discussions be summarized in the inspection report.
C.
Comment Our review of sei -+ed compliance files indicated that, in at least six cases, previous non-compliance items were not addressed on the " Findings of Violations" report.
Recommendation It is recommended that, although the State uses the "318" form, which is acceptable, previous non-compliance items be addressed in summary form on the inspection report. This would highlight any repetitive violations and the inspector could then discuss them during the inspection.
D.
Comment In our review of selected compliance files, it was noted that in at least. three cases, the State did not acknowledge the licensees' responses to cited non-compliance items.
Recommendation It is recommended that the State acknowledge the licensees' responses to cited non-compliance items or other responses to letters following inspections.
It was also noted that in several cases the licensees' responses to violations did not describe in sufficient detail the corrective action or were otherwise not completely responsive.
It is
5 recommended that the inspectors and supervisors review the licensees' responses to assure that they are complete, accurate, and address the citations.
E.
Comment Contrary to the radiation control program's policy, we found in some cases, that formal enforcement letters were not sent to the licensee detailing the cited non-compliance items.
Recommendation We recommend that your internal policies be followed including in cases were there are no violations cited, and formal letters be sent to the licensee.
F.
Comment It was noted that in at least five compliance reports, the type of inspection was not stated 1.e., announced vs. unannounced, partial vs. complete,. routine vs. followup.
Recommendation It is recommended that the type of inspection be indicated in the introductory portion of the inspection report along with the previous non-compliance items.
This again would provide a brief synopsis for the supervisory reviewer and for the next inspector to review prior to the next inspection.
IV.
Personnel Coment and Recommendation The following comment and recommendation, relating to Training, a Category II indicator, is made.
(
We recommend that the Department's new staff member attend the next NRC sponsored " Industrial Radiography" and " Licensing Orientation" courses.
NRC will fund the travel and per diem costs for persons approved for such training.
4/16/82
- = Compatibility Item
- = Strongly encour adoption by Stz CHRONOLOGY Amendments to be Considered by Agreement States (from September 1971)
Suggested State Effective Date 10 CFR Part Reculations Summarv Sept. 24, 1971 20 Part C. Sch. B
- Addition of an exempt l
30 Part 0, App. B quantity for BA-133.
M2rch 26, 1972 20 A. 3, C.40
- Addition and modification 30 C.100, 0.207 of transport and packaging 40 procedures.
70 71 1
Nov. 2, 1972 20 Part 0, App. A
- Changes in values of radionuclides of uil concentrations in air l
and water.
Sept. 17, 1973 19 Part J
- Requirements for notices, instructions and reports by licensees to workers, and options available to workers with regard to inspections.
Oct. 24, 1973 20 A.2(i)
- Change to abbreviations l
30 Part B, Sch. A for " curie" and " micro-l 32 Part 0, App. A curie," and addition of l
. and App. B definition for "millicuri e. "
l Jan. 10, 1974 31 C.22(i)
Authorization to use 32 C.28(h) carbon-14 in in vitro clinical or lacoratory tests.
M;rch 11, 1974 30 C.40
- Requirement that suppliers 31 must verify that customers 40 are authorized to receive 70 the material shipped.
150 l
July 29, 1974 30 A.2(i) -
- Special curie definitions Part 0 and concentration values Appendix for U and Th.
Suggested State Effective Date 10 CFR Part Reoulations Summarv Aug. 16, 1974 31 C.22(h)
Addition of 3H and 59Fe 32 C.26(c) to in vitro tests and 35 C.28(h) extension of Medical C.28(j)
Group licensing.
Jan. 15, 1975 31 C.22(d)
. Modification of require-32 C.28(d) ments for distribution of 31.5 GL devices.
A.3(c)
Clarification of AEC Jan. 19, 1975 contractors exemption pursuant to Energy Reorganization Act.
Requrements for control June 25, 1975 20 0.206 of licensed material in unrestricted areas and g in storage.
t June 25, 1975 35 Part'C, Sch. C Addition of I-125 seeds for interstitial treatment of cancer to Group VI.
i Jan. 19, 1976 20 0.1(a)
Incorporation of "As Low As Is Reasonably Achiev-able (ALARA)" wording.
Jan. 29, 1976 20 Part 0, App. A Modification of occucational exposure limit for Rn-222.
Feb. 23, 1976 35 Part C, Sch. C Addition of tin-113/
indium-113m generators to Group III.
April 19,1976 35 Part C, Sch. C Addition of ytterbium-169 DTPA for cisernography to Group II.
Juna 2, 1976 20 Parts C, O Requirements for 31 and E preservation of certain 32 records required by the 34 regulations.
10 70 150
3 Suggested State Effective Date 10 CFR Part Reoulations Summary Aug. 4, 1976 34 E.203 Personnel monitoring requirements for industrial radiographers.
Aug. 16, 1976 35 Part C, Sch. C Addition of I-125 fibrinogen for detection of deep vein thrombosis to Group II.
Dec. 29, 1976 20 D.103
- Authorizes use of respirators.
Bases internal exposure limits on intake into the body.
Jan. 5, 1977 40 C.21(d)
- Es'tablishes GL for depleted uranium products.
March 7, 1977 40 C.3(c)
- Exemption for personnel
- neutron dosimeters containing thorium.
May 31, 1977 31 C.22(i)
Addition of SE-75 to i_n vitro GL.
32 (C.28(h) n June 27, 1977 31 C.22(i)
Addition of mock 32 C.28(h) iodine-125 calibration sources to _in vitro GL.
August 15, 1977 35 C.26(b)
Modification of requirements for indivi-dual physician use of radioactive material for human use.
Jan. 6, 1978 40 C.21(a)
Extends small quantity source material GL to Federal, State and local governments for operational purposes.
Jan. 16, 1978 35 Part C, Sch. C Addition of Tc-99m human serum albumin for heart blood pool imaging to Group III.
Feb. 7, 1978 35 Part C, Sch. C Addition of Tc-99m 4
medronate sodium for bone imaging to Group III.
4 Suggested State Effective Date 10 CFR Part Reculations Summary Feb. 16, 178 30 C.4(c)
- Exemption for spark gap irradiators containing cobalt-60.
M2rch 14, 1978 20
'D.203(c)
- Additional requirmeents for controlling areas in which radiation levels in excess of 500 rems /hr exist.
June 16, 1978 35 Part C, Sch. C Addition of Tc-99m gluceptate sodium for brain and renal perfusion imaging to Group III.
~
Juns 23, 1978 20 0.203(f)
- Removal or defacing of radioactive material labels on empty containers.
i Sapt. 7, 1978 35 Part C, Sch. C Addition of Tc-99m human serum albumin microspheres for venography to Group III.
D:c. 28, 1978 35 G.2(c)
- Requirement to perform survey of patients to confirm that implants have been removed.
March 22, 1979 35 Part C, Sch. C Deletion of diagnostic procedures from medical groups.
Junn 5, 1979 30 C.31(d)
Notice of discontinued 40 licensed operations.
70 July 9, 1979 35 G.3(d)(e), (f),
- Teletherapy calibrations (g),(h)
August 20, 1979 19 0.1,
- Control of radiation to 20 0.101, 0.102 transient workers.
J.13
- Modification of September 27, 1979 71 C.100
'- transportation requirements.
l
5 Suggested State Effective Date 10 CFR Part
. Reculations Summarv M rch 3, 1980 34 Part E
- Amendments to industrial C.26(e) radiography requirements.
March 28, 1980 71 A.3(b)
Corr:ction to reference C.101 Postal service regulations.
September 2, 1980 35 C.26(c)
Testing of radioisotope generators.
Scptember 19, 1980 40 C.21(a)
Deletion of GL for source material medicinals.
Navember 10, 1980 35 0.409 Medicai misadministration reporting.
Requirements to implement l
Nsvember 17, 1980 40 A.2 C.25(e),(f),(g) the Uranium Mill Tailings (h)
Act i
i C.29
(
Part C, Sch. E 0:cember 1, 1980 20 0.106(g)
Reference to 40 CFR 190 for uranium fuel cycle-oper.ations.
January 28, 1981 20 0.304
- Deletion of waste burial authori::ati.on March 6,.1981 35 Part C, Sch. C Addition of Tc 99m I
oxidronate sodium to l
Group III l
March 13,1981 34 E.203(b)
Disposal of p~ocket dosimeter records.
l March 31, 1981 20 D.306 Biomedical waste rule 1
M y 13, 1981 30 C.4(c)
- Exemotion for survey instrument calibration sources.
. - ~
Encl. 3 FEB i 1982 Ira :.. Byers,I;.0.
State healb Officer State Depart =ent of r.ealth Stata Office Building nut:;omery, Alahaua 36130 dear ur. Ayars:
Several events in Agreesent Itates have highlightad the desirability of having authority to apply civil penalties @.en violattens of radiation safety requir: cents ara found.
In tae su:r.er of 1979, consiceracle local and national publicity focused on a plant in Tuscon, Arizona unich esnufactured self-lur.iimus derices containing a radioactive isotope, triticm.
5311, but detactsele acounts of trittui:: trere found in unrestricted areas around the plant, including foodstuffs prepared in a school kitchen nearty and swinr.ifng pcols.
Certain organizational and procedural problems encountered by the State agency having regulatory responsibility ifnited the effective-ness of its enforcement actions. On Septacter ZS.1979. in testimony l,efore the.irizona Senate !:ealth. Welfare and.;ging Cr.:sittee, we offered rec::nvendations for correcting these problems. Taase reccanendations included asendina the Arizona statuta to authorize the State radiation control agency to impose civil penalties. The Arizona legislature sucsequently acted favorably on this recourendation and tvernor Mbbitt signed the bill into law.
The Arizona hdiation P.cquiat:ry Ar;cncy has prepared civil penalty regulations.
also la 1979, Colorado's Covernor Lam requested the Colorado Oureau of Investigation (CSI) to investigata allegations of criminal lew violations by a uranius mill operator.
CSI's report of its investigation was issued in Scpmer,15i0.
One of its conclusions was that the Colorado Department of Health's enforcement actions acainst the v.fil operator were r.ot always as effective as they could have been. Gur revieve of this natter, which included discussions witn- ;olorado represtintatives, f adicated agreacent with the finding that Colorado Cepart:.ent of i;calth enforcer. ant actions were not as effective as they could have been. We reezr. ended to Culorado that, among other icarovements, they seek civil penalty authority to use as an additional enforcement teol to help icprove safety perforrance of licensees.
Legislation for this purpose was intrWed in 1951 but the legislature did not act on it.
It has been re-introduced in 1932.
Ira L 117ers, M.D.
- In hoveoiser 1931, CLS' "Sa Minutes" presented a progra= on a ranagement/
labor dis;,uta at a Tennessae a:anufacturer of decleted uranium projectiles which centerec on radiation safety issues. The Tennessce Division of Radiological Health is respor.sible for replating the radiological hazards from the use of the uranium at this plant.
Based upon cur review of anforcemenc correspondence exchanged by Tennessee and the itcensee and our discussions with the Tennessee Livision of Radiological health staff, we concluded that the Division has been diligent in inspecting the plant operations, identifying violations of State radiation protectica requirements and seeking corrective action. Monetheless, in testizony before a Congressional Subcoss.ittee chaired by Representative Albert Gore, on December 3,1931. Mr. J. A. B111 Grahan, Director of the Division stated that civil penalty authority would have been helpful in obtainino i
quicker correction of violations and that the State would seek such authority. ile also testified at this hearing and reconscended the state seek civil penalty authority.
All Agreement States have authority to levy crimin3l penalties upon judicial findings of violations of State law concerning protection of public health and safety arising from the use of radioactive matarials.
Additionally, all Agreement States have authority to issue Orders =odifying licenses, including suspension and revocation, when necessary to protect pubife health and safety. However, only a few Aareecent States have authority to apply civil monetary penalties.
nRC has authority to apply civil monetary penalties under Section 234 of the Atocic Energy Act, as Wad. iiRC's experience has shown that civil penalty authority is a valuable enforcement tool which encourages licensee compliance.
Frc= an enforcenent perspective, civil penalties represent an effective, intercediate alternative to suspendinc or revoking a ifcense, which should be reserved for core severe concomplianco i
situations.
It is notaworthy that the report of the littional Govcenors' Association on low-level radioactive waste discosal (August,1980) contained a recow.cndation that Agreement States should be encouraged to adopt civil penalty authority.
It sees.s that it takes a sajor event such as those described above to initiate a proposal to seek civil penalty authority. He would hope that the ai,ove examples would prompt you to seriously considar such a prograc.
Louisiana and South Carolina have authority to apply civil penalties and have utilized it.
You may wish to discuss the rerits of such a pronrem wit: officials of these States regarding their experienccs.
I urge each Agreecent State that has not already done so to seek authori:y to apply l
l l
I l
l l
IraLjHyers.H.D. '
civil penalties as an integral part of its enforear.ent progrr.: for radioactive caterials. The present Suggested Radiation Control Nde!
..ct includes provisions for civil penalty aut::ority and should be nelpful to this regard.
The Sw.tgested Act has been submittad by the Office of Manage. Ant and Budget to the Council of State Governconts fse adoptica as a nodal Act. A copy of the f.odel Act has been furnished to the Girector of your radiation control procram.
I would appreciate receiving your thoughts on this :stter.
If your prograa presently has civil penalty authority, a statement of your vicus on its value would be helpful to us. We are always available to meet with you ar.d other members of the State Government, including the legislature, either to present testimony on or to discuss this catter.
Sincerely, G. Llayne Kerr, Director Office of State Programs cc: Tir. lubrey Gouwin 1
l l
l l
1
. _,... _ ~ _ _ _ _ _
davi,I Axelrud ;i.3., Cecissicant
.Stata departcent of :!calth
!.:gire State Pia::a -
Towr Niluing Albany, neu York 12237 cc:
I'r. acrnic i-ca14, ',hief R/..; Liccusing Se.::tiva Stato cesart::wnt of !!calth Enfrc Stata Pla::a Tower Bufiding
/.lbany, l!aw York 12237
- 'r. Robert F. Flacke, Ccmisticner
.icw York State Depart:ent of Environnental Conscrvation CO Ucif F. cad Maany, ficu York 12223 cc:
Tir. Thc:as J. Casiwan. Catef Toxic ~. tdf ation Section
.aw Ycri Stata ucrartr.ent of Enviru mental casarvation 50 Woif ricad Albany, itew York 12233
.'fGEuT1cA 1ETTERS
'is. Lill fan 1;oberts Ir.dustrial Cc:smissicner OM sew York Stata departncnt of Labor
- ' World Trade conter
- its Tcrt, itew Yort ICC47 F. J. Bracicy,'Ph.;
cc:
Principal :'.adiophysicist Radiolocfcal Health :.c1t
- lew York State Occartncnt of Labor 2 Woric Trade i. enter l
'tew York, new Yort 10047
.cviu J. Sencur, ii.s., Cctr.issioner i;ew York City ^e::artnent of Tcalth 125 Werth Street l
- .eu York, Hau York iCC13 cc:
Laenard Solon, Ph..), Gf rector Surnau of P.adiation Centrol
!iew York City T.upart:ent of Health 377 Broauuy ih York, Jew Yori.
10013
2 REPORT AND STAFF EVALUATION OF THE NEW YORK STATE DEPARTMENT OF LABOR RADIATION CONTROL PROGRAM FOR THE PERIOD MARCH 27 1981 to APRIL 23, 1982 The 20th regulatory program review meeting with New York Department of Labor was held during the week of April 19-23, 1982, in New York City.
The Depart-ment was represented by Dr. Francis Bradley, Principal Radiophysicist; Mr. George Kasyk, Associate Radiophysicist; and Mr. Louis Cabasino, Senior Radiophysicist.
The NRC was represented by Mr. John McGrath and Mr. Ralph S. Heyer.
A review of selected license and compliance files was conducted by Mr. McGrath and Mr. Heyer on April 20-23, 1982.
A field accompaniment with Mr. Herb Michaels was conducted by Mr. Heyer on April 19, 1982.
A summary meeting regarding the results of the regulatory program review was held with Deputy Industrial Commissioner Edward Maher, Mr. Joseph Drayton, Director of the Division of Safety and Health and Dr. Francis Bradley.
Conclusions At the time of the review, no finding was offered concerning the New York Department of Labor (NYDOL) program for control of Agreement materials as regards to adequacy to protect public health and safety nor compatibility with the regulatory programs of the NRC and the Agreement State.
Significant pro-blems were found in program areas for which the indicators are in Categories I and II.
We have requested additional information in the form of responses to our letters to the Industrial Commissioner before a staff evaluation on the adequacy and compatibility of the program can be offered.
l These conclusions are based on the review of the technical and administrative l
aspects of the Department's regulatory program for Agreement materials.
i Included in this review were examinations of selected licensing and compliance files, information related to the program indicators specified in the
" Guidelines for NRC Review of Agreement State Radiation Control Programs," the results of accompaniment of a State inspector, the continuing exchange-of-information program between the State and the NRC and a review of licenses issued by NYDOL since March 27, 1981.
Summary Discussion with Deputy Industrial Commissioner Maher A summary meeting to present the results of the regulatory program review was held with Mr. Maher on April 23, 1982 in New York City, New York.
Also attending this summary meeting were Dr. Francis Bradley, Mr. Joseph Drayton and Mr. John McGrath, Office of State Programs.
The following comments and recommendations were made to Mr. Maher.
1.
The " status of regulations" is a Category I Indicator.
The Industrial Code Rule No. 38 has not been updated since July 10, 1978.
Several changes have been made to NRC 10 CFR Parts 19 and 20 and thus it was recommended that the State begin revising and updat'rq Code Rule 38 to include the applicable changes to NRC regulations.
2.
There appeared to be a serious problem with the " Technical Quality of Licensing Actions" indicator.
This has been a repeat comment following each review since 1979.
Since the technical quality of
i 3
i licensing actions is another Category I indicator we could not make a determination at this time as to a finding of adequacy and compatibility.
i 3.
A comment was made with regard to " Enforcement Procedures" indicator.
During the meeting with the Deputy Industrial Commissioner it was noted that adoption of civil penalties would provide an additional enforcement tool for the Department.. A copy of an Agreement State letter discussing the civil penalty issue was attached _to the letter of comments and recommendations to Industrial Commissioner Roberts.
4.
We also recommended the possible addition of a word processing system for the Department.
Cue to the increased number of applica-tions for radioactive materials being submitted to the Department of Labor it was noted that a word processor could store information relative to issuance of licenses as well as maintaining work load statistics.
5.
It was noted to the Deputy Industrial Commissioner that the Department's standing in relation to other programs' salary levels has steadily decreased.
Since this may be a problem in the future we recommended that the staff salaries be monitored to assure that they remain competitive and do not become a factor adversely affecting the programs ability to attract and retain qualified staff.
l 6.
It was identified upon review of selected compliance files that the inspection reports did not document adequately certain items of non-compliance, health and safety matters and did not completely j
document inspection findings.
This comment and recommendation was made to assure that documentation is adequately done.
Summary Discussions with Dr. Francis Bradley The following comments and recommendations were made to Dr. Bradley and his staff following the review:
1.
It was recommended that applicants for new licenses and for license renewals submit operating and emergency procedures, have detailed procedures for receipt and handling of radioactive material and that the health physics manuals used by the license applicant be appro-priately updated to assure that they are consistent with current State and Federal regulations.
We also commented on the need to renew, at least the Priority I licenses, in their entirety at no greater than five to six year intervals.
All these comments are under the " Technical Quality of Licensing Actions" indicator which is a " Category I" indicator.
2.
It was recommended that attention be directed toward documentation of worker interviews following an inspection, listing any previous items of non-compliance, acknowledging the licensee's response to non-compliance items, identifying the type of inspection conducted, and lastly, issuing a formal enforcement letter detailing the cited n
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4 non-compliance items consistent with the Department's policy.
These items are all under the compliance section and are Category II indicators.
3.
We recommend the newest staff member attend the " Industrial Radiography" " Inspection Procedures" and " Orientation" courses.
This comment is under training, a Category II indicator.
Program Changes Related to Previous NRC Comments and Recommendations 1.
Licensing A.
Comment During the review of selected license files concerning the implementation of our comments from last year, it was noted that licenses requiring bioassay for tritium lacked an action plan to deal with elevated levels of tritium in urine.
This is a significant deficiency.
Recommendation We again recommend that licensees using uncontained tritium be required to state what action will be taken with regard to workers whose urine shows levels of tritium above prescribed action levels.
State Response All licenses are being reviewed for tritium possession limits.
Any license authorizing more than 100 millicuries of Hydrogen 3 is revised and the following conditions are added:
(1)
Individuals involved in operations which utilize, at any one time, more than 100 millicuries of Hydrogen 3 (Tritium) in a non-contained form, other than metallic foil, shall have bioassays performed within one week following a single operation and at weekly intervals for continuing operations.
(2) Tritium shall not be used in such a manner as to cause any individual to receive a radiation exposure such that urinary excretion rates exceed 28 microcuries of Tritium per liter when averaged over a calendar quarter.
(3) Urinalysis shall be performed at weekly intervals on all individuals who work in the controlled areas of facilities in which Tritium is used.
If the average concentration of Tritium in urine for any single individual during a calendar quarter is less than 10 microcuries per liter, urinalysis may be performed on chat individual at monthly intervals for the following calendar quarter and may continue at monthly intervals so long as the average concentration in the calendar quarter remains below 10 microcuries per liter.
The urine specimen shall be collected on the same day of the week insofar as possible.
5 (4) A report of an average concentration in excess of the limit specified in 2 above for any individual shall be filed, in writing, within thirty (30) days of the end of the calendar quarter with the Radiological Health Unit, Division of Safety and Health, State of New York Department of Labor, 2 World Trade Center, New York, New York 10047.
The report shall contain the results of all urinalyses for the individual during the calendar quarter, the cause of the excessive concentra-tions, and the corrective steps taken or planned to assure against a recurrence.
(5) Any single urinalysis which discloses a concentration of greater than 50 microcuries per liter shall be reported, in writing, within seven (7) days of the licensee's receipt of the results to the Radiological health Unit, Division of Safety and Health, State of New York Department of Labor, 2 World Trade Center, New York, New York 10047.
Furthermore we are requiring in the firm's Radiation Safety Manual (or Health Physics Manual) provide a graded response program to increased bicassay contamination levels (in this regard we would appreciate any advice from NRC on the suitableness of the 28 micro-curies, T/1 (SIC) of urine as equivalent to 5 rem /y; some of our licensees are claiming following ANSI N13-N721 that value of approx-imately 49 microcuries, T/1 of urine-5 rem /y please give us any recommendations you have on this matter it has considerable economic importance and revisions in value should be done uniformly in Agreement and non-Agreement States).
Present Status A review of selected license files did identify that any license l
authorizing more than 100 millicuries of Tritium was revised.
The 28 microcurie of Tritium per liter limit was implemented as well as the limits and contaiticns specified in the above " state response" section.
All were incorporated in thosc selected license files that were reviewed.
By letter dated December 17, 1981 the NRC responded to the 28 microcurie of Tritium per liter limit and supplied Dr. Bradley with the requested supporting information.
B.
Comment A review of selected license files indicated in several instances that the staff had not adequately documented telephone conversations.
This is a minor deficiency.
l Recommendation l
l We recommend that the staff adequately document telephone conversations relating to licensing actions.
6 State Response An " Action Sheet" form is used by the licensing group (copy is available in the Agreement State File).
Present Status It was noted upon review of selected license files that the " Action Sheet" was being used to document telephone conversations.
C.
Comment and Recommendation We recommend that when a license is renewed, that the staff insure the license is amended in its entirety superceeding all ottar licensing documents.
State Response Within the limitations of staff time and incoming licensing workload the complete revision of extensively amended existing licenses will be implemented.
Present Status This was a repeat comment on this review.
The problem of renewing of licensing in entirety still persists.
It was recommended by this reviewer that at least the Priority I licenses be renewed in entirety at no more than 5-6 year intervals.
2.
Compliance l
A.
Comment l
A review of selected compliance files indicated that worker interviews were not adequately documented in inspection reports.
Discussion with the staff indicated that the inspectors do not routinely interview workers.
This comment was made during last year's review.
Recommendation We recommend that radiation workers be interviewed to determine the extent of their knowledge of radiation safety, regulatory require-ments and emergency procedures.
These interviews should be documented in summary form in the inspection report.
State Response This item was discussed with staff and will be highlighted in the review of inspection forms to ensure that it is being implemented and documented.
7 Present Status Review of selected compliance file identified that in some cases documentation of worker interviews was recorded.
However, again this was a repeat comment and it was recommended that worker inter-views be conducted and documented accordingly.
Upon discussion with staff, it was identified that worker interviews were being conducted but in some cases not documented.
B.
Comment As a result of last year's review, we recommended that the inspection report format be revised to include the date and noncompliance items, if any, from the previous inspection.
The use of the 313 card was considered acceptable.
However, it was noted that enforcement letters do not identify previous items of noncompliance.
Recommendation We believe enforcement letters should highlight the findings of repetitive violations and that the licensee should be requested to state in his reply not only when and what will be done to correct noncompliance items, but also what will be done to prevent a recur-rence.
Example of letters of this nature were furnished in an All Agreement State letter dated November 14, 1978, a copy of which is enclosed.
State Response In future compliance letters repeat violations will be highlighted and depending on the seriousness of the repeat violations will be cause for escalated enforcement action unless appropriate control actions are taken.
Present Status l
l Review of selected compliance files identified that previous items of non-compliance were only documented on the 318 card.
This reviewer recommended that they also be documented specifically in the inspection report.
3.
Training A.
Comment It was noted that since our last review approximately 12 months ago there was no training provided for the professional staff.
This i
comment was made during last year's review.
l Recommendation We again recommend that the professional staff, especially the new members, be afforded the opportunity to at*.end NRC sponsored training
==
l f
8 courses.
We recommend that the newest staff member attend the licensing course currently scheduled to be held in September 1981.
State Response We are pleased to announce that since this comment and recommendation was received that three radiophysicists have or are receiving additional training as follows:
(1)
L. Cabasino, Course
" Safety Aspects of Industrial Radiography l
for State Regulatory Personnel; June 1-5, 1981 (2)
H. Michael, Course
" Safety Aspects of Industrial Radiography for State Regulatory Personnel; August 24-28, 1981 (3)
G. Kasyk, Course
" Orientation Course in Licensing Practices and Procedures" l
September 14-25, 1981 1
Present Status i
The previous year's comment on training was properly responded to by the State.
This reviewer also recommended that the newest profes-sional staff member attend the " Industrial Radiography," " Inspection l
Procedures" and Orientation" courses.
I l
9 LEGISLATION AND REGULAT'UNS Legal Authority (I)
There has been no change in the statutory authority of the Department.
Statutory authority for the radiation control program, New York Department of Labor remains the same as for the other New York offices.
New York Depart-ment of Labor remains responsible for industrial applications of radioactive material whereas the other three offices, New York State Health, New York City Department of Health and New York Department of Environment Conservation, maintain regulatory responsibilities over other types of license applications.
Status of Regulations (I)
The last total revision of the New York Department of Labor Part 38 of Title 12 of the Official Compilation of Codes, Rules and Regulations of the State of New York (Cited as 12 NYCRR 38) was in July 1978.
The Department's regulations with respect to NRC 10 CFR Parts 19 and 20 need to be updated to maintain a high degree of uniformity and consistency.
Updating of Regulations (II)
The New York Department of Labor has established procedures for effecting appropriate amendments to Industrial Code Rule No. 38 and to update the Code at five year intervals.
It was learned during the review that the next update and revision is scheduled for July 1983.
Due to the extensive amount of staff time as well as legislative actions required to update the regulations, the Department should initiate work on the next revision as soon as possible.
ORGANIZATION Location of the Radiation Control Program within the State Organization (II)
There has been no change in the location of the Radiation Control Program (RCP) in the Department of Labor'.
A copy of the organizational chart is attached to Appendix E.
Internal Organization of the Radiation Control Program (II)
There has been several changes to the internal organization of the New York Department of Labor since the last review.
There is a new Industrial Commis-sioner, Ms. Lilian Roberts; a new Deputy Industrial Commissioner, Mr. Edward Maher; and a new Director for the Division of Safety and Health, Mr. Joseph Drayton.
Legal Assistance (II)
Legal staff are assigned to the Radiological Health Unit (RHU) on a case-by-case basis by the Department Counsel.
The legal staff are familiar with Industrial Code Rule 38 and its ramifications.
10 Technical Advisory Committee (II)
There are no technical advisory committees.
Dr. Bradley stated that for unique or very technically complex problems the NRC may be contacted.
As of the date of this review there were no unique or complex applications received by the Department.
There is no medical advisory committee in the Department of Labor since this Department only handles industrial license applications.
MANAGEMENT AND ADMINISTRATION Quality of Emergency Planning (I)
The Department of Labor is a resource agency to the Department of Health under the New York State emergency plan.
However, for any industrial radiological emergencies in which there is no release to the environment, the Department of Labor responds directly and takes appropriate action.
These procedures remain unchanged from the previous reviews.
The plan does outline the responsibil-ities and actions to be taken by each agency in New York.
Persons responsible for initiating response actions, emergency communication procedures and notification of appropriate local, county and State agencies are covered in this plan.
Budget l
The period covered by NYDOL fiscal year is April 1 to March 31.
The source of funds for the RCP is from general tax revenues.
The total budget designated for radioactive material for FY 83 is $250,000.
There are 404 active licenses in the Department, thus the funding level is $614 per license.
l It was noted during the review that approximately $1000 for the West Valley Low Level Waste Disposal site is used.
Upon further discussion it was iden-i tified that.1 person / year is utilized for this dormant site.
According to Dr. Bradley, the Department is responsible for any activities and every indi-vidual at the waste site as well as for the environmental sampling activities as long as the site is in existence.
SA Staff notes, however, that the New York Department of Environmental Conservation also has regulatory responsibility for environmental aspects of the LLW site at West Valley.
Laboratory Support (II)
A laboratory for analysis of radiation in samples collected by the RCP staff is located on the same floor as the Department in the number 2 World Trade Center building.
The program staff analyze their own samples.
A Nuclear Chicago Windowless flow counter with automatic sample change capability and Packard Tricarb liquid scintillation counter with automatic sample change l
capability is utilized.
All professional staff members are familiar with the use and handling of this equipment.
l
I 11 Administrative Procedures (II)
The RCP has licensing and inspecticn guides that have been evaluated in the past and found adequate.
The RCP has developed a new licensing requirements list for review of moisture and density gauges.
This check list had been prepared for applicants requesting a license and appears to be sufficient.
(Attached as Appendix A.)
A radiography manual instruction sheet was also developed and given to applicants in order to provide a " cook book" format for preparation of a radiography manual.
This instruction sheet details written procedures for shipping and receiving radioactive material.
(Attached as Appendix B.)
The Department also uses a standard letter (DOSH 240.3) " Bond for Removal of Radioactive Materials and/or Decontamination of Installations" to assure that sufficient funds are available for decontamination, restoration and reclama-tion of licensed facilities upon completion of operations.
(Attached as Appendix C.)
It was identified that communication between the licensing staff and inspection staff is adequate.
The Department does have a public relations individual who handles public relations and press releases.
The NRC as well as Agreement States are notified when NYD0L issues a press release.
Management (II)
All statistics on licenses arid inspections conducted, as well as violations cited are maintained by the RCP and furnished to NRC on a semiannual basis.
Due to the small size of the office the RCP management can assess werkload trends, resources and any changes in legislative and regulatory responsibilities periodically without problem.
The principal radiophysicist continuously conducts reviews of licensing actions with the associate radiophysicists and reviews any Priority I licenses that may be issued.
All the inspection reports and enforcement actions are also l
reviewed and signed by the principal radiophysicist after the cases have been l
completed by the inspector.
I Office Equipment and Support Facilities (II)
There are 1.5 person years clerical effort involved in the Agreement State Program.
The Department does not have any automatic typing capability avail-able.
It appears that there is adequate secretarial support, however. it was recommended that a word processor would assist the RCP greatly.
This comment was addressed in our letter to the Department Management.
l Public Information (II) l RCP licensing and inspection files are not available for perusal by the public except by request to Department Counsel.
It was stated by Dr. Bradley that there are no exceptions.
4 12
' PERSONNEL Qualifications of Technical Staff (II)
There has been an addition of a new staff member to the RCP (Resume attached as Appendix D).
Thus there are two secretarial staff; Dr. Bradley, Principal Radiophysicist; George Kasyk, Associated Radiophysicist; Louis Cabasino, Senior Radiophysicist; Andrew Awai (new) Senior Radiophysicist; Herb Michaels, Senior Radiophysicist and, Robert Kelley, located in Buffalo.
Mr. Kelley reports administratively to the New York office and technically to Dr. Bradley.
There have been no changes in the personnel pcaition descriptions since the last review.
The agency requires that all professional staff possess the academic training and experience equivalent to a Bachelor's Degree in the physicial or life sciences.
Additional training and/or a higher degree is required for senior level positions.
Vacancies are advertised by the Civil Service Commission and ads are placed in newspapers and professional journals.
s Staffing Level (II)
A total of.5.65 person years of effort is applied to the Agreement materials program. ' This staff effort' is composed of the following:
Name Staff Years Activities F. J. Bradley 0.90 Management G. L.Kasyk 0.95 Licensing
-L. S. Cabasino 0.95 Compliance R. Kelley (Buffalo) 0.95 Compliance H. Michaels 0.95 Licensing / Compliance A. Awai,
0.95 Licensing / Compliance 5.65 Considering the 404 active licenses in the program as of this review, person years expended was 1.3 per 100 licenses.
This is between the 1.0-1.5 person year per 100 license suggested by the NRC guideline.
It was noted that approximately.1 person year is utilized for the West Valley Waste Burial site:
This factor,is incorporated in the above calculations and the monetary. details explained in the budget section of this report.
Staff Supervision.(II)
Supervisory personnel hork with the staff very closely.
This can be accomplished quite readily due to the size ano location of all but one of the personnel being located in one office, (Robert Kelle.v, an inspector, is located in the Buffalo office and continues to report technically to Dr. Bradley).
The, following is a list of designated responsibilities and duties for all staff members:
13 Name Duties & Responsibilities 1.
B. L. Kasyk, H. Michael, A. Awai Review licenses 2.
G. L. Kasyk Sign licenses 3.
L. Cabasino, R. Kelley, H. Michael, Perform inspections A. Awai 4.
G. L. Kasyk, F. J. Bradley Evaluate Inspector performance Review inspection reports Sign enforcement letters 5.
L. Cabasino, R. Kelley, H. Michael, Perform duties in A. Awai environmental surveillance 6.
G. Kasyk, L. Cabasino, F. J. Bradley Emergency planning activities Supervise junior personnel 7.
L. Cabasino, F. J. Bradley Set inspection priorities and assign inspections The newest staff member (Andrew Awai) *nitially is working on license applications and inspecting small programs under close supervision.
Training (II)
The RCP has an informal on-the-job-training program for new employees.
They work under close supervision with senior personnel until they are adequately trained and able to function independently.
The participation of the RCP in NRC training courses has improved in the past year.
During the period since the last review, G. Kasyk attended the NRC Licensing Orientation Course, L. Cabasino and H. Michaels attended the NRC Industrial Radiography Course and H. Michaels attended the NRC 10 week Health Physics Course.
It was recommended during this review that the new staff member attend the NRC sponsored " Inspection Procedures," " Industrial Radicgraphy" and " Orientation" courses.
Staff Continuity (II)
The current salary levels in the radiation control program are as follows:
Position Salary Range l
Principal Radiophysicist
$33,515-$38,810 l
Associate Radiophysicist
$24,440-$28,660 l
Senior Radiophysicist
$18,000-$22,285 It was stated by Dr. Bradley that sir.ce the RCP has hired two new Senior Radiophysicists in the past 1.5 years the Department "will have to wait and see about the retention of junior staff."
It was noted that in the 1981 job market that it was difficult for the RCP to attract qualified personnel at the entrance level salary for Senior Radiophysicist position.
It was commented by the reviewer, in the letter of findings to Commissioner Roberts, that the professional salary levels were comparable to the other New York Offices in the past.
However, there has been a noticeable decrease in
14 the Department's standing in relation to other Agreement State programs.
This was identified as a possible problem in the future and it was recommended that staff salaries be monitored to assure that they remain competative and do not become a factor adversely affecting the programs ability to attract and retain qualified staff.
In addition, due to the size of the programfthe promotion potential of junior personnel is currently limited.
There was one individual who has left the program (Mr. L. Schuster) through retirement.
LICENSING Technical Quality of Licensing Actions (I)
The program uses licensing guides that have been evaluated by the NRC.
The license reviewers use checklists comparable to those of other Agreement States.
Licensing actions are coordinated with the inspectors.
The applicants are notified within 1-2 weeks that their application has been received.
Initial action is taken on license review within 30 days.
License expiration notices are sent out 90 days prior to expiration date.
The license files are kept in an orderly fashion, however, due to the extensive number of amendments to licenses (averaging between 15-30) it was difficult to follow any changes and additions.
This comment was made to the staff and addressed in the letter to the Commissioner.
It was recommended that a license renewal action be based on a complete, updated application that will supercede all previous licensing documents.
It was also recommended that initially, at least, the Priority I licenses be renewed at no more than 5-6 year intervals.
There were 4 prelicensing visits conducted since the last review.
Two at Truton (US) Limited and two at Carrier Air Conditioning.
Currently, the program has 404 active licenses.
There were 24 new licenses (see Appendix E) and 242 amendments issued.
The license files that were reviewed had some repeated comments from the previous review as well as several additional items.
The results of the selected license file review are attached in Appendix I.
Adequacy of Product Evaluations (I)
During the review two sealed source and devices were evaluated and ten were pe, ding.
Mr. Kasyk conducted the review for the two devices; Self-Powered Lighting--Luminous aircraft signs and Self-Powered Lighting--Aircraft eye alignment device.
It was noted that the evaluations of manufacturers' data of the sealen sources and devices were conducted using an NRC outline.
Licensing Procedures (II)
A list of standard licensing conditions similar to the NRC's conditions are being used by the State and a copy is attached as Appendix G.
The licensing staff uses internal licensing guides, checklists and policy memoranda consis-tent with NRC practices.
License applicants are furnished with copies of applicable guides and are also assisted by the RCP staff.
t t
15 All licenses are issued for three years and all compliance history and current status are considered in licensing actions.
The files are maintained in an orderly fashion except for the extensive amount of amendments issued per license.
Details on selected license file reviews are attached as Appendix I.*
COMPLIANCE Status of Inspection Program (I)
During the review of selected compliance files it was noted that the RCP maintains an inspection program that is adequate to assess licensees' compli-ance with State regulations and license conditions.
However, it was difficult to search through a license with numerous amendments in preparation for an 1
inspection.
Mr. Cabasino has done a commendable job in maintaining the number of overdue inspections at a minimum.
During the last review 161 inspections were overdue (20 Priority I).
During this review 11 Priority I, 36 Priority II, and 21 Priority III were overdue.
This represents a decrease from 161 overdue inspections in 1981, to 68 in 1982.
The priority classification list (revised in 1978) is attached in Appendix H.
In the Priority I classification five were overdue by more than 15 months, in the Priority II nine were overdue by 24 months and Priority III all by 6 months.
Inspector's Performance and Capability (I)
On April 19, 1982 an accompaniment of Herb Michaels was conducted and the report is attached as Appendix K.
The inspectors performance was found adequate.
The compliance supervisor, Mr. Cabasino, conducts routine supervisory accompaniments and field evaluations to assess the performance and assure the application of appropriate and consistent policies and guides by the inspectors.
Response to Actual and Alleged Incidents (I)
The program investigated 10 incidents during the year.
Investigations were promptly conducted.
Investigations are written in detail and documented in the files as well as submitted to the NRC in the Semi-Annual Reports.
A review of selected reports included an Isotope Production Laboratories lost Cs-137 source on February 20, 1981; and a Schlumberger accident involving Cs-137, Co-60 and Ra-226 sources on August 25, 1981.
All of the incidents were examined in appropriate depth and the reports included calculations by j
the Department for whole body and extremity exposure.
i The licensees in the State of New York are responsible for the diagnosis and treatment of injuries including radiation to their employees.
There are
-emergency procedures for this incorporated in many of the licensees' response plans.
However, it was noted that the State may require a second medical i
Note:
A special review of Radium Chemical Company, Inc. was conducted to determine current status of facility.
(See Appendix I.)
l.
16 l
opinion in which a list of medical consultants would be requested from the NRC or DOE and consultation would be provided directly to the State.
Enforcement Procedures (I)
According to RCP policy, enforcement letters are written on all significant items of noncompliance and always on Priority I licensees when items of non-compliance are found.
In routine inspections of Priority I and II licensees, a notice of inspection findings is left with the licensee with instruction to correct the items and respond within 10-30 days.
The radiophysicist who performs the inspection, reviews the licensee's response for adequacy and if acceptable is then acknowledged.
If not, further or additional information may be requested to be submitted.
The New York Department of Labor does not 1
have civil penalty authority and this issue was discussed with Department Management and addressed in our letter.
Inspection Procedures (II)
Inspection guides and policy guides are used by the compliance staff.
All inspections are unannounced and exit interviews are conducted with licensee management.
The inspection reports are reviewed and initialed by Dr. Bradley signifying completion of the inspection.
All inspection information goes into the file.
Verbal briefing of licensing staff is conducted only in exceptional compliance cases.
Inspection Reports (II) l l
Inspection reports generally contained substantiation of items of noncompliance and health and safety matters.
However, our review of selected compliance files disclosed that certain items that are normally part of DOL procedures, were not documented.
These included conducting worker interviews and docu-menting them, previous items of noncompliance were not specified in the report but were on 318 cards (which are used to itemize the cited noncompliance item and respective license condition).
Review of selected compliance files also identified that formal written enforcement letters were missing in some reports.
See details in " Review of Selecte'd Compliance Files" attached in Appendix J.
These comments were discussed with the staff as well as being addressed in our letter.
Independent Measurements (II)
It is the policy of the Department to conduct indpendent measurements of licenses operations to verify survey and check documentation.
It appears that the instruments available are adequate for surveying all types of licensed operations (i.e., geiger-meter counters, lapel air samplers, filters for collection of air samples, and smoke tubes and velometers for ventilation j
studies).
Annual instrument calibration is performed using sources with I
calibration traceable to NBS.
More frequent spot checks for constancy of readings are made using small check sources.
Calibrations are performed by State calibration laboratory and outside commercial calibration firms for j
which State pays a fee.
t m.
- - ~
17 OTHER AREAS AFFECTING THE ADEQUACY OF THE DEPARTMENT OF LABOR'S RADIATION CONTROL PROGRAM The information on the Department's NARM program is included in overall " Unit Statistics." Data on the number of NARM and Agreement Material licenses and inspections are varied.
Most licensees with NARM also possess agreement material.
Thus, exact number of licenses and inspections could not be obtained.
The following data on the number of x-ray registrants, by category, is an approximation derived from the State's Annual Report to USPHS:
Category Number 1.
Facilities using x ray devices
$1000 2.
Radiographic or fluoroscopic devices
$300 3.
Analytic x-ray devices
- 200 4.
Industrial Radiography services
$35 The number of particle accelerator registrants in the State is approximately 30.
These facilities are not inspected (except by special request) by the State.
Routine inspection efforts are deferred to the Federal OSHA.
l l
l LIST OF APPENDICES 4
A.
Licensing Requirements for Moisture / Density Gauges B.
Radiography Manual Instruction C.
Bond for Removal of Radioactive Materials D.
New Employee Resume E.
Organizational Chart F.
Priority I Radioactive Material Licenses G.
Standard Licensing Conditions H.
Inspection Priorities I.
Review of Selected License Files J.
Review of Selected Compliance Files K.
Field Evaluation of Inspector Accompaniment t
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LICENSING REQUIREMENTS FOR MOISTURE / DENSITY GAUGES In order to expedite the review of an application, detailed information muct be submitted as required on DOSH-237(Application "B").
IMPORTANT:
Each supplementary sheet to the application must be identified by com-plete company address, date of the application, Item it belongs to and No. of pages(1 of 6 ; etc).
Use separate pages for each individual Item.
I.
Firm Location.
Give the exact address and zoning (must be industrial or commercial) for the Installation.
Licenses are not issued to P.O.
Boxes.
II.
Be sure to include a complete description of the Moisture / Den-sity Gauge (s) and sealed Source (s) (Model Nos. Isotope (s)
Activity etc.).
III.
Explain where and how the Gauge will be stored.
It must be in a steel locked cabinet, preferrably in an unoccupied secure area.
If the Gauge is at a mobile laboratory the cabinet must be secured.
IV.
Prevention of unauthorized use of the Gauge.
Detail security during the day and after hours.
V.
What is the nature of the building construction.
Is it fire-proff, are t hr e sprinklers, or fire extenguishers?
VI.
List the qualification of person proposed to be the Radiation Safety Officer.
A copy of the certificate of training with the Gauge applied for must be included for each operator.
VII.
Describe your personnel exposures monitoring procedures.
l Account for both gamma and neutron exposures to operators.
l i
Provide an estimate for both, the dose to a Gauge operator under full time use and the dose to the general public, if any.
VIII.
Include written Operating and Emergency Instructions, vnien must include detailed procedures for establishment of controlled area, posting of signs, step by step operation of the Gauge with particular attention to limiting unnecessary exposures, such as standing close to the Gauge during counting, moving the Gauge to new counting location without putting the source into shielded position, never transporting the Gauge in the driver's compartment and limiting carrying the Gauge for long distances close to the body.
4 A s W 1 lX h
%...a..
o Page 2 VIII.
(Cont.)
Provide the Emergenc'y telephone number and who will respond if an accident, vehicular or field should occur (must be qualified Licensed person !).
If the Gauge is going to be transported and stored overnight in company vehicle, include instructions and security.
At no time shall the Gauge be taken inside a private residence or a motel room overnight.
IMPORTANT:
This should be a fascimile or list of what the Gauge operator must have with him in the field.
The operator must also carry copy of the License and of all amendments, personal identifi-a cation, authorization to use the Gauge, a copy of Code Rule 38, Leak test Certificate, Notice to Employees, Radioactive Materials Warning Sign and Emergency Equipment (Rope, Signs, Stands).
IX.
You must keep a record of use of the Gauge, a utilization log.
Provide this Department with either a sample, or description of what information you will record.
It must include the Model and Serial Number, date, time of day the Gauge is removed from j
storage, name of the operator, destination, time of day and date Gauge is returned and signature or initial of the Operator.
l l
X.
If you are requesting possession of several Gauges submit a procedure for inventory control and physical examinations of the Gauges at six ' month intervals.
XI.
Who will service the Gauge?
It must be done by either the Manufacturer or by a specifically licensed person.
XII.
Who will leak test the Gauge:
Specify procedure.
l l
XIII. How will you dispose of the radioactive material if no longer needed? (manufacturer or a licensed waste disposal firm only).
(
RADIOGR]iPHY MANUAL INSTRUCTIONS Your attention is invited to the new Industrial Code Rule No.38,
" Ionizing Radiation Protection" (12 NYCRR 38), effective July 10, 1978, Section 39 entitled " Transportation", Subdivision (c), which now requires detailed written procedures for receiving and ship-ping radioactive materials.
The manual should be compiled along the following guidelines:
1.
The manual should be constructed as loose leaf book to facili-tate changes of sections.
2.
There should be an index with date of issue, clearly identi-fying each individual section of the manual by caption, date and number of pages.
3.
Sections should have each page numbered, dated and signed by compiler.
Copies of printed regulations and/or manuals may be inserted.
Individual section shall contain, but need not be restricted to:
a.
New York State Industrial Code Rule No.38, " Ionizing Radiation Protection" (12 NYCRR 38), effective July 10, 1978, Appendix A.4.
Subdivisions (b) and (c).
The training manual Subdivision (b) and a sample of qualifying examination together with approved answers should be separate from the operating and emergency procedures, Sub-division (c).
If your company plans not to be approved for the training and periodic retraining or refresher for radiographers a procedure shall be submitted courses as to how this will be accomplished.
b.
Separate operating instructions for each licensed device and its normal radiation levels.
c.
Sample of all forms and records, such as survey forms, daily log, equipment check out list, etc. used in the process of radiography and inventory control of sources, together with detailed instructions of how to fill them out.
Copy of license with all amendments and of Code Rule 38.
d.
Description of inspection and maintenance program for radiographic equipment prior to deployment.
Step by step instructions of how to perform radiography e.
and exchange sources in orderly and safe way.
i y
, f.
If room radio, graphy is part of licensee's operation, annotated drawing of the facility, radiation survey of each individual room under worst possible condit. ion, all safety devices such as interlocks, alarms, barriers and other protective devices shall be described and their operation and purpose explained.
g.
Deta ted description and drawing of proposed isotope stor..ge area, with safeguards and expected radiation levels.
i
BOND FOR RS40 VAL OF RADIOACTIVE MATERIALS AND/OR DECONTAMINATION OF ESTALLATIONS KNOW ALL MSI BI THESE PRESBiTS:
That as Principal, (Insert name and address of Licensee) and as Surety, (Insert name and address of Surety) cro held and firmly bound as Obligors to the Industrial Commissioner of the State of New York, his successors and assigns, as Obligee, in the sum of Ten Thousand ($10,000)
Dollars lawful money of the United States for which payment whereof said Principal and Sursty bind themselves, their heirs, executors, administrators, successors and assigns, jointly and severally, by these presents;
'Ihat the said Principal, pursuant to Title 12 of the New York State Official Compilation of Codes, Rules and Regulations Chapter I, Sub-chapter A. Part 38 (Indus-trial Code Rule No. 38) Relating to Radiation Protection, has applied for and been granted a license or amended license (a copy of which license, including all amend-m:nts thereto, is by reference made a part hereof) to transfer, receive, possess, use or store certain radioactive materials described in such license and, pursuant to S:ction 38 7 of such Part 38 (Industrial Code Rule No. 38) has been required to furnish this bond; NOW, THEREFORE, THE CONDITION OF THIS OBLIGATIDN is such that, if the Prin. cipal, when so ordered by the Industrial Commissioner' of the State of New York, fails to remove radioactive materials and/or to decontaminate installations as provided in Section 38.16 of such Part 38 (Industrial Code Rule No. 38), then he and his Surety shall be liable to the Obligee for any expenses, not exceeding the sum of this bond, incurred by the Industrial Commissioner of the State of New York in exercising his powers of removal and/or decontamination pursuant to said Section 38.16.
IT E rwan it UNDERSTOOD AND AGREED that this bond shall be in effect during the entire period of said license, amendments thereto, and renewals thereof issued to the Principal above-named, provided, however, that the Surety, upon thirty (30) days' notice by certified mail to the Industrial Cc=missioner of the State of New York, at his office, Two World Trade Center, New York, New York 10047, and to the Principal at the address stated in the license, may cancel this bond, except to the extent of any liability thereon that may have accrued or arisen as a result of an order of the Industrial Commissioner pursuant to Section 38.16 issued prior to the effective date of such cancellation.
Signed and sealed this day of
, 197 IN THE PRESHICE OF:
PRECIPAL SUREIY DOSH-240.7 (8-76) f f.EEUt31
(_
D.
APPENDIX E LOCATION OF THE RCP WITHIN THE STATE ORGANIZATION L.
R berts LABOR COMMISSIONER DOL DIRECTOR J.F.
Drayton DIVISION OF SAFETY AND HEALTH l
CHIEF F.J.
Bradley RADIOLCGICAL HEALTH UNIT l
l LICENSING PROGRAM INSPECTION PROGRAM G.L.
Kasyk F.J.
Bradley/L. Cabasino
m..
M i
NEW YORK STATE DEPARTMENT OF LABOR DIVISION OF SAFETY AND HEALTH RADIOLOGICAL HEALTH UNIT RADIACTIVE MATERIAL LICENSES (No. 1)
A.J.
Testing Laboratories, Inc.
Adirondack Steel Casting Co.,
Inc.
580 Myrtle Avenue Metalurgical Laboratory Brooklyn, New York 11205 Watervliet, New York 12189 RSO:
A.J.
Massaro RSO:
William D.
Hollander Airco Carbon African Metals Corporation A Division of Airco, Inc.
123 William Street Packard Road at 47th Street New York, New York 10038 Niagara Falls, New York 14302 RSO:
James L.
Kindsey,.J r.
RSO:
Richard W.
Pysz The Air Preheater Co.,
Inc.
Albany Engineered Systems Wellsville, New York 14895 P.O.
Box 310 RSO:
Max N.
Allen Glens Falls, New York 12801 RSO:
Jeffrey B.
Duncan Alliance Tool Corp.
Becton, Dickinson Immunodiagnostics 2 Jet View Drive Mountain View Avenue Ro c hs t e r, New York 14624 Orangeburgh, New York 10962 RSO:
G.
Short RSO:
Herman Rutner Atlas Steel Casting Company Branch Radiographic Laboratories, Inc.
1963 Elmwood Avenue Non-Destructive Testing Dept.
Buffalo, New York 14207 28 South Avenue West i RSO:
Thomas Herdlein Cranford, New Jersey 07016 l
RSO:
William H.
Branch, Sr.
The Bendix Corporation Bulova Watch Company, Inc.
Electrical Comp >nents Div.
75-20 Astoria Boulevard Delaware Avenue Flushing, New York 11370 Sidney, New York 13838 RSO:
William Santo RSO:
Paul D.
Moore Blaw-Know Buffalo X-Ray Company l Food and Chemical Equipment Inc.
81-83 East Market Street l 750 East Ferry Street Buffalo, New York 14240 l Buffalo, New York 14240 RSO:
Donald Bolling RSO:
Donald R.
nalchow i
l ha. ; L;j ;:
t
Priority No. 1 Pago 2 Celspan Corporation Certified Testing Laboratories, Inc P.O.
Box 235 2623 Roberts Avenue 4455 Genesee Street Bronx, New Yo rk 104 61-Buffalo, New York 14221 RSO:
Robert R.
Plumstead RSO:
Raymond F.
Missert Chicago Bridge & Iron Company Combustion Engineering, Inc.
8900 Fairbanks-North Houston Road 1000 Prospect Hill Road Houston, Texas 77040 Windsor, Connecticut 06095 RSO:
Darwin C.
Wilbur RSO:
Reynold L. Hoover Consolidated X-Ray Service Corp.
Consolidated Tes tin g Laborato ries,In 6 Woodbridge Avenue 79 Herrick Road Woodbridge, New Jersey 07095 New Hyde Park, New York 11040 RSO:
J.
Lee Ballard RSO:
Richard Wood Consolidated Testing Laboratories, Dresser Transportation Equipment Inc.
Division 76 Herrick Road 2 Main Street New Hyde Park, New York 11040 Depew, New York 14043 RSO:
Richard Wood RSO:
K.L.
Wilson EAD Metallurgical Inc.
Eastman Kodak Company 71 Pearce Avenue Marketing Education Center.
Tonawanda, New York 14150 4545 East River Road RSO:
Eugene Oleksy West Henrietta, New York RSO:
Richard F.
Scherberger l
Foster Wheeler Energy Corp.
Foster Wheeler Energy Corporation l
Quality Centrol Department Quality Control Department l
Radiographic Section 110 South Orange Avenue l
Dansville, New York 14437 Livington, New Jersey 07039 i
RSO:
T.
Hayes RSO:
F.B.
Kovacs Genecast Carrier Corp.
Division of General Railway Signal Co.
Carrier Parkway l
801 West Avenue Syracuse, New York 13221
[
Rochester, New York 14602 RSO:
H.
Ridler I
RSO:
R.
Miller Ebasco Services Inc.
Subsidiary of Halliburton Co.
Building 100-Port Kearny South Kearry, New Jersey 07032 RSO:
R.
Allikberg l
Pric icy No. 1 Pago.3 9
Excolco Developments, Inc.
General Electric Co.
Inspection Dept.
600 Main St.
-Mill Street i
Johnson City, New York 13790 Silver Creek, New York 14136 RSO:
W.
Kuehl Attn:
M. Pilwoski General Electric Company Grumman Aerospace Corporation One River Road Industrial Safety & Hygiene Schenectady, New York 12345 Mail Stop B-33-02 RSO:
J.S.
Shockley, Jr.
RSO:
Robert H.
Pargmann Herbert Products, Inc.
IBM Corp.
180 Linden Avenue Neighborhood Road Westbury, New York 11590 Kingston, New York 12401 RSO:
John C.
Herbert Atta:
E.
Formica ITT Grinnell Corporation Lederle' Laboratories l 260 West Exchange Street Division of American Cyanamid Co.
Providence, Rhode Island 02901 Pearl River, New York 10965 RSO:
Joseph G.
Kowalski RSO:
Robert H.
Blank Municipal Testing Laboratory, Inc.
N.Y.
Testing Laboratories, Inc.
160 Lauman Lane 81 Urban Avenue Hicksville, New York 11801 Westbury, New York 11590 RSO:
Claude E.
Jaycox RSO:
Elliot M.
Huff, Jr.
NL Industries, Inc.
Nuclear Associates Nuclear Metals Division Division of Victoreen 1130 Central Avenue 100 Voice Road Albany, New York 12205 Carle Place, New York 11514 RSO:
A.
Potter RSO:
Malcolm D.
Powell Nuclear Diagnostic Laboratories, Inc.
Nuclear Fuel Services, Inc.
1000 Lower South Street A Subsidiary of Getty 011 Co.
Peakskill, New York 10566 P.O.
Box 124 RSO:
Alan Jones RSO:
Richard T.
Smokowski Numax Electronics Inc.
Nuclear Radiation Devel., Corp.
720 Old Willets Path 2937 Alt Boulevard Hauppauge, New York 11787 Grand Island, New Y0rk 14072
" RSO:
Frederick Beck RSO:
J.D.
McGraw Pan American World Airways Peabody Testing Services Non-Destructive Testing Lab.
A Division of Magnaflux Corp.
Jet Cen ter Building 208 7800 West Lawrence Avenue JFK International Airport Chicago, Illinois 60656 Jamaica, New York 11430 RSO:
Earl L.
Banfield RSO:
J.P.
Baust i
_.... _. -, _ _.. - ~
-.~
e Priority No. 1 Pego 4 ITT Grinnell Industrial Piping, Inc.
Peabody Testing Services Old Highway 421 A Division of Magnaflux Corp.
Kornersv111e, North Carolina 27284 986 Oliver Street RSO:
D.
Harris North Tonawanda, New York 141 RSO:
E.
Banfield Pittsburgh Des Moines Steel Company Pittsburgh Testing Lab.
Neville Island 605 Young Street Pittsburgh, PA 15225 Tonawanda, New York 14150 RSO:
William J.
Weisner RSO:
Joseph Gentile Pittsburgh Testing Laboratory RAI Research Corp.
6159 East Molloy Road 225 Marcus Boulevard East Syracuse, New York 13057 Hauppauge, New York 11787 RSO:
Walter J.
Peters RSO:
Vincent F.
D'Agostino Redium Chemical Company, Inc.
Radiac Research Corporation 161 East 42 Street 261 Kent Avenue New York, New York 10017 Brooklyn, New York 11211 RSO:
W.
Koegl RSO:
John V.
Tekin Rochester Gas and Electric Corp.
Radatron Division 84 East Avenue Mark IV Industries Rochester, New York 14649 2424 Niagara Falls, Blvd.
RSO:
Donald McCormack North Tonawanda, New York 1412 RSO:
John Perbach Self-Powered Lighting, Ltd.
Simmonds Precision Engine 8 Uestchester Plaza Systems, Inc.
Elmsford, New York 10523 Norwich-Oxford Road RSO:
William Hegarty Norwich, New York 13815 j
RSO:
Edward L.
Mooney TII Corporation Stone & Webster Engineering 100 North Strong Avenue Corp.
Lindenhurst, New York 11757 245 Summer Street RSO:
Seymour I.
Megoff Boston, Massachusetts, 02210 RSO:
James D.
Gibson Tuboco, Inc.
Tennessee Gas Pipeline Co.
iQuality Control Dept.
Division of Tenneco, Inc.
123 Varick Avenue Tennessee Circle Brooklyn, New York 11237 RSO:
David L.
Gulbertson lRSO:
John V.
Cronise i
i L
Priority No. 1 Pago 5 Twin City Testing Corp.
Shil-la Ar t Gems, Inc.
107-111 Goundry Street 50 West 47 St.
North Tonawanda, New York 14120 New York, New York 10036 RSO:
Boris B.
Joffe Attn:
B.T.
Cho Schwarz-Mann, Inc.
Trek Inc.
2 Ram Ridge Road 1674 Quaker Road Spring Valley, New York 10977 Barker, New York 14012 Attn:
S.
Allen RSO:
Bruce T.
Williams Trutom(US) Limited Tri State Industrial Laundries 790 Waterviet-Shaker Road 1634 Lincoln Avenue Lathan, New York Utica, New York 13502 Attn:
R.
Pfannewstiel RSO:
J.
Peplinski Union Carbide Corporation Union Carbide Corp.
Process and Product Development Sterling Forest Research Cente 61 East Park Drive P.O.
Box 324 Tonawanda, New York 14150 Tuxedo, New York 10987 RSO:
T.
Smist RSO:
Dr.
J.
Agresta UPA Technology, Inc.
Worthington Compressors, Inc.
60 Oak Drive Quality Assurance Department Syosset, New York 11791 Clinton and Roberts Streets RSO:
Jadwiga Strzeiczyk Buffalo, New York 14240 RSO:
Joseph M.
Eiszewski l
(
I i
us:=:- sr
.G. EASYK
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NEW YORK S'IATE DEPARIMEtE OF IABOR RADIOIDGICAL HEAL'IH UNIT
\\,
STANDARD LICENSDU OCNDITICNS
\\,
BASED CN STATE AND U.S. NRC EXPERIENCE N.\\
4 l
l REVISED April 1, 1978 07
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_1 I
GE2ERAL CDNDITIONS Iccation of Use (1)
A.
Radioactive materials shall be used only at the licensee's address stated in Corxiition 2 above.
B.
Radioactive materials shall be used only at (2)
Radioactive materials may be used at and at twWrary job sites of the licensee throughout the State of New York.
(3)
RMimetive materials shall be used only at tarporary job sites of the licensee throughout the State of New York.
(4)
RMiettive materials may be used anywhere in Radiation Standards (5)
'Ihe licensee shall ccuply with the provisions of the State of New York Industrial Code Rule No.38, *'Radthienjis5EliEMen" (12NYCRR 38),
as assaded-effective En
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7# Zoniziony Radinkot. % fac M" Authorized Users (6)
Radioactive materials shall be used by (7)
Radioactive materials shall be used by, or under the supervision of, (8)
RMimetive materials shall be used by, or under the supervision and in the physical presence of, (9)
A.
RMimetive naterials shall be used by, or under the supervision of, individuals designated by the B.
'Ihe use of radioactive materials, in or on humans shall be by a
- 1ysician.
Application and docuent reference (10)
Except as specifically provided otherwise by this Li. cense, the licensee shall receive, possess, use and transfer radioactive materials in
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, acmrdance with statments, representations and procedures contained in his application dated
, with attactment, and in related %==nts as follows:
(11) 'Ihis license does not authorize the camercial distribution of exengt quan-tities of byproduct material pursuant to Dampticm 28, Table 1, Secticn 38.
41, 12 NYCRR 38.
(12) The licensee shall report in writing within 30 days to the Chief, Radio-logical Health. Unit, Division of Safety and Health, New York State Depart-ment Of Iabor, 2 World Trade Center, New York, New York 10047, the loss or abrunmi:nt of any sealed source containing licensed material. 'Ihe report shall include information regarding isotope, amount, location, depth, method of innobilizatim, sealing, placarding, and notations to be placed in public records.
(13) The licensee shall not use rMbwtive materials in or en hunan beings or in field apolications where activity is released except as provided otherwise ~
by specific ocoditions of this license.
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made available to each person working with or naving respuimu.,m radioactive materials pursuant to Sectico 38.34(b) of Industrial No. 38.
'Ihe manual and Code Rule shall be followed and any cha' manual affecting the safety and health of persons shall be suP this Department for license amendment prior to issuance to pr (18) 'Zhe licensee shall comply with Iocal Law No. 49/71 " Air Pr Ccde" of the City of New York Department of Air Resourr (19) 'Ihe licensee shall ocuply with Part 380 Rules and Recr of New York Departnent of Environmental Conservatior
t
. 2-accordance with statments, representaticms and procedures contained in his applicatica dated
, with attachment, and in related <h =mts as follcus:
(11) mis license does not authorize the er==rcial distribution of exengt quan-tities of byproduct material pursuant to Exsipticn 28, Table 1, Section 38.
41, 12 NYCRR 38.
(12) The licensee shall report in writing within 30 days to the mief, Radio-logical Health Unit, Division of Safety and Health, New York State Depart-ment Of r.nhne, 2 World Trade Center, New York, New York 10047, the loss or aba&mmit of any sealed source containing licensed material. The report shall include informaticn regarding isotope, amount, location, depth, method of innobilizaticn, saaling, plar-arding, and notations to be placed in public recAds.
w (13) The licensee shall not use radioactive materials in or on human beings or in field applications where activit
' - ' ' - - " - ~
by specific conditions of this 1
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i5iide' available to each person wc_.__..,
radioactive materials pursuant to Section 38.34(b) of Industrial Code Rule No. 38.
De manual and (bde Rule shall be followed and any change in the manual affecting the safety and health of persons shall be subnitted to this Department for license Eureldrait prior to issuance to personnel.
(18) The licensee shall ctmply with Iocal Iaw No. 49/71 " Air Pollution Control Cbde" of the City of New York Department of Air Resources.
(19) he licensee shall ocuply with Part 380 Rules and Regulations of the State of New York Department of Environmental Cnservation,
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D accordance with statements, representaticns and pra wes contained in his application dated with attachment, and in related Av'==nts as follows:
(11) 21s license does not authorize the acumercial distribution of exenpt quan-tities of byproduct material pursuant to Exenpticm 28, Table 1, Section 38.
41, 12 NYCRR 38.
(12) The licensee shall report in writing within 30 days to the Chief, Radio-logical Health. Unit, Division of Safety and Health, New York State Depart-ment Of W r, 2 World Trade Center, New York, New York 10047, the loss or abandonment of any sealed source containing licensed material.
The report shall include information regarding isotope, amount, location, depth, method of in=+4112ation, sealing, placarding, and notations to be placed in public records.
(13) The licensee shall not use radioactive materials in or on hunan beings or in field applications where activity is released except as provided otherwise '
by specific conditions of this license.
'(14) Experimental animals adninistered radioactive materials or their products shall not be used for hunan cxmstaption.
i I(15) Radioactive materials shall not be used in or on hunan beings or in products distributed to the public.
i (16) The licensee shall subnit revised plans and specifications of the exhaust l
system in Ocndition of this license, or any new systuu involving the L
use of radiopctive materials, to this Department ifor approval prior to making alterations of or additions to the systan, or the installatico of a new systen.
(17) The licensee's Radiation Protection Program manual specified in Cbndition of this license, including a copy of the Code Rule, shall be made available to each person working with or having responsibility for radioactive materials pursuant to Section 38.34(b) of Industrial Code Rule No. 38.
We manual and (bde Rule shall be followed and any change in the manual affecting the safety and health of persons shall be subnitted to this Department for license amendment prior to issuance to personnel.
9 (18) The~ licensee shall crnply with Im.al Iaw No. 49/71 " Air Pollution Control Cbde" of the City of New York Department of Air Resources.
(19) The licensee shall ccuply with Part 380 Rules and Regulations of the State of New York Department of EnvuTamm.stal Conservation,
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l II. SEALED SOURCES Handling of Sealed Sources (1)
Sealed sources containing radioactive material shall not be opened.
(2)
Sealed sources containing radioactive material shall not be cpened or remaved frts their respective source holders by the licensee.
(3)
Sealed sources centaining raaimetive material shall not be opened or renaved frcm by the licensee.
(4)
'Ihe licensee shall not open/or repair sealed sources.
- LEAK TEST.
For broad licenses and for licenses to persons who fabricate sour:es:
(5)
A.. (1)
Each sealed source acquired frcm another person and contain-ing radim_ctive material, other than Hydrogen 3, with a half-life greater than thirty days and in any form other than gas shall be tested for contamination and/or leakage prior to use.
In the absence of a certificate frm a transferor indicating that a test has been made within six manths prior to the transfer, the sealed source shall not be put into use until tested.
(2)
Notwithstanding the periodic leak test required by this condition, any licensed sealed source is exerpt frcm such leak tests wh'en the source contains 100 microcuries or less of beta and/or ganma emitting material or 10 microcuries or less of alpha enitting material.
COMENT
'Ihe % tion in 5.A. (3) may be applied where, in judgenent of the license reviewer, health and safety will not be ccuprcmised.
(3)
Except for alpha sources, the periodic leak test required by this condition does not apply to sealed sources that are stored and not being used.
'Ihe sources excepted frm this test shall be tested for leakage prior to any use or transfer to another person unless they have been leak tested within six nonths prior to the date of use or transfer.
B.
Each sealed source fabricated by the licensee shall be inspected and tested for construction defects, leakage and centamination prior to use or transfer as a sealed source.
If the inspection or test reveals any construction defects or 0.005 microcurie or i
greater of contamination, the source shall not be used or trans-ferred as a sealed source until it has been. w ed and de-
' contaminated.
s gf, 5
f C.
Each eaaled source containing radioactive material, other than Hydrogen 3 wit' a half-life greater than thirty days and in any form other than gas,
sha',1 be tested for leakage and/or contamination at intervals not to ex-ceed six nonths euwt. that each source designed for the purpose of snit-ting alpha particles shall be tested at intervals not to exceed three nonths.
D.
The test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sanple.
We test satple shall be taken frm the sealed source or frcm the surfaces of the device in which the sealed source is pezmanently or senipe.rmanently nounted or stored on which one might expect contanination to accanulate.
Records of leak test results shall be kept in units of microcuries and maintained for inspect-ion by the Departsnent.
E.
If the test required by Subsection A. or C. of this condition reveals the presence of 0.005 microcuries or nere of renovable contamination, the licensee shall inmediately withdraw the sealed source frcm use and shall cause it to be decontaminated and repaired or to be disposed of in accord-ance with 12 NYCRR 38.
A report shall be filed within 5 days of the test with the Clief, Radiological Health Unit, Division of Safety and Health, New York State Department of Labor, 2 World Trade Center, New York 10047, describing the equignent involved, the test results, and corrective action taken.
OMENT ne following condition is leak test condition for neutron and beta gama sources only.
Section D. belcw which specifies by whcm the leak test shall be carried out, may be cmitted where it is inappropriate, (6) A. (1)
Each sealed source containing radioactive material other than Hydrogen 3, with a half-life greater than thirty days and in any for;n other than gas shall be tested for leakage and/or contamination at intervals not to exceed six months.
In the absence of a certif-icate frcm a transferor indicating that a test has been made within six nonths prior to the transfer, the sealed source shall not by'put into use until tested.
(2)
Notwithstanding the periodic leak test required by this condition, any licensed sealed source is exeupt fran such leak tests when the source contains 100 microcuries or less of beta and/or ganma enit-ting material or 10 microcuries or less of alpha enitting material.
We exception in 6.A.
nent of the license reviewer, health and safety will not be can-(3) be prcmised.
F
,,,o s
(3)
'Ihe periodic leak test required by this condition does not apply to scaled sources that are stored and not being used. The sources ex-cepted frun this test shall be tested for leakage prior to any use or transfer to another person unless they have been leak tested within six nonths prior to the date of use or transfer.
B.
'Ihe test shall be capable of detecting the presence of 0.005 microcurie of radinactive material on the test sanple. The test sanple shall be taken frcm the sealed source or frcm the surfaces of the device in which the sealed source is permanently nounted or stored on which one might ex-pect contamination to a m = late.
Pecords of leak test results shall be kept in units of microcuries and maintained for inspection by the Depart-ment.
C.
If the test reveals the presence cf 0.005 microcurie or more of renovable contaminaticn, the licensee shall.imnediately withdraw the sealed source fran use and shall cause it to be decontaminated and repaired or to be dis-posed of in accordance with 12 NYCRR 38. A report shall be filed within 5 days of the test with the Chief, Radiological Health Unit, Division of Safety and Health, New York State Department of Iabor, 2 World Trade CLnter, New York,' New York 10047, dxMbing the equi ment involved, the F
test results, and the corrective action taken.
D.
Tests for leakage and/or contamination shall be performed by
, or by other persons specifically authorized oy the U.S. Nuclear Regulatory Ccmmission, or other Agreement State to perfoz;m such services.
CDtHENT
'Ihe follcwing condition is the leak test condition for alpha neutron and r
g beta-ganma sources. This condition contains a section which. specifies by whcm the leak test shall be canied out.
E*ch sealed scurce containing radioactive. material other than Hydgo-(7) A. (1) a f
gen 3, with a half-life greater than thirty days and in any fopn otheg than gas shall be tested for leakage and/or contamination at intervals not to exceed six nonths, except that each source designed for the pug-
)
pose of snitting alpha particles shall be tested at intervals not to exceed three months.
In the absence of certificate frcm a transfegorg indicating that a test has been made within six months prior to the transfer, the sealed source shall not be put into use until tested, (2)
Notwithstanding the periodic leak test required by this conditicng apy licensed sealed source is excrnpt fran such leak. tests when the source contains 100 microcuries or less of beta and/or gagna emitting nategigl or 10 microcuries or less of alpha unitting materia,1 9
4
,/ -
B.
We test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample.
We test sanple shall be taken frcm the sealed source or from the surfaces of the device in which the sealed source is permanently mounted or stored on which one might ewect contamination to accumlate.
Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Department.
C.
If the test reveals the presence of 0.005 microcurie or more of re-movable contanination, the licensee shall immediately withdraw the sealed source frcm use and shall cause it to be decontaminated and re-paired or to be disposed of in accordance with 12 NYCRR 38.
A report shall be filed within five days of the test with the Chief, Radiological Health Unit, Division of Safety and Health, New York State Department of Iabor, 2 World Trade Center, New York, New York 10047, des-cribing the equignent involved, the test results, and the corrective action taken.
D.
Tests for leakage and/or contamination shall be performed by
, or other persons specifically authorized by the Department, U.S. Nuclear Regulatory Ctanission, or other Agrement State to perform such services.
E.
S e licensee shall have sealed sources tested for leakage of radioactive materials pursuant to Section 38.26(f) of Industrial Code Rule No. 38.
shall only be performed by persons specifically licensed by this Department, Te.sts the Stato DT *nt of Health, the New York City Department of Health, the U.S. Nuclea-1 tory Ccannission services.
or other Agreement State to perform such CO MEtI2
'Ihis condition provides for leak test intervals of three specified equipment.
ypars for certain (8)A.
(1) shall be tested for leakage and/or contamination at intervals not to exceed three years.
In the absence of a certificate from a transferor indicating that a test has been made within six nonths prior to the transfer, the sealed source shall not be put into use until tested.
(2)Notwithstanding the periodic leak test required by this condition, any licensed sealed source is exstpt from such leak tests when the source contains 100 microcuries or less of beta and/or garma material or 10 microcuries or less of alpha anitting material.
'Ihm ewtion 8.A. (3) may be applied where, in the judgment of the license reviewer, health and safety will not be ump m aised.
(3)2e pericdic leak test required by this condition does not apply to sealed sources that are stored and not being used.
W e source excepted fran this test shall be tested for 1 leakage prior to any use or transfer to another person unless they have been leak tested within six nonths prior to the date of use or transfer.
9 v.., -
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- vi. ion in 7.A. (3) may be applied where, in the judgrnent of the license reviewer, health and safety will not be caprcInised.
(3)
Except for alpha sources, the periodic leak test required by this condition does not apply to sealed sources that are stored and not being used. Se sources excepted frcza this test shall be tested for leakage prior to any use or transfer to another person unless they have been leak tested within six nonths prior to the date of use or transfer.
i B.
Se test shall be capable of detecting the presence of 0.005 microcurie of radie=ctive material on the test sanple.
Se test saple shall be taken frun the sealed source or frun the surfaces of the device in which the sealed source is pezmanently mounted or stored on which one might expect contamination to acctzrnlate.
Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Departsnent.
C.
If the test reveals the presence of 0.005 microcurie or more of renova-ble contamination, the licensee shall i==diately withdraw the sealed source frczn use and shall ause it to the decontaminated and rapaired or to be AW-ed of in accordance with 12 NYCRR 38. A report shall be filed within 5 days of the test with the 011ef, Radiological Health 7
Unit, Division of Safety and Health, New York State napart2nent of Iabor, 2 World Trade Center, New York, New York 10047, describing the-
{
equipment involved, the test results, and the corrective action taken.
D.
Tests for 1=#aa= and/or contamination shall be performed by l
, or by other persons specifically authorized by the Departsnent, the U.S. Nuclear Regulatory 0:Innission, i
i or other Agreenent State to perform sudt services.
(9)
Each sealed source of licensed material to be used outside of a shiel-ded exposure device shall bear a durable, legible, and visible tag permanently attached to the source. Se tag shall be at least one(1) inch square, shall bear the conventional radiation syntol prescribed in subdivision 38.31 (a),12 NYCRR 38, and a minimum of the following instructions:
DANGER-RADIQACTIVE MATERIAL-DO NOT HANDLE-NorIFY CIVIL AUIHORITIES (and/or other authority if appropriate)
IF FtXJND. Repair or rep 3acement of tags shall be acccuplished by persons specifically licensed by the Department, the U.S. Nuclear Regulatory 02mtission, or other Agreement State to perform this service.
(10)
Each sealed source of licensed radioactive material to be used outside of a shielded exposure device shall bear a durable, legible, and visible l
tag permanently attached to the source. Se tag shall be at least one (1) inch square, shall bear the conventional radiation symbol prescribed in subdivision 38.31 (a),12 NYCRR 38, and a mini:ntzn of the following ins-tructions: DANGER-RADIOACTIVE MATERIAL-DO NOT HANDLE-NorIFY MILITARY AUIHORITIES IF ET)UND. Repair or replacenent of tags shall be acotztplished by persons specifically licensed by the Depart 2nent, the U.S. Nuclear 1
Regulatory Ctanission, or other Agreement State to perfoz2n this service.
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III _Cas omMRTOGRAPHY (1)
Detector cells containing foil shall only be used in conjunction with a prcperly operating tenperature control mechanism whis prevents foil t==wetures fran scWing degrees Centigrade.
(2)
In lieu of using the conventional radiation caution colors.(magenta or purple on yellov background) as provided in subdivision 38.31(a),
12 NYCRR 38, the licensee is hereby authorized to label detector cells and cell baths, containing radioactive materials and used in gas
& rana %4hy devices, with conspicuously etched or s+ a==1 radiation *4~1 rjnbols without a color requirenent.
(3)'
A.-
Each chu.metug41 detector containing Nickel 63 shall be tested for leakage and/or contamination at intervals not to exceed six nonths.
In absence cf a certificate frun a transferor indicating that a test has been made within six months prior to the transfe.r, the detector shall not be put into use until tested.
B.
%e test shall be r =pable of detecting the presence of 0.005 micro-curie of radioactive material on the test sanple. Se test i
sanple shall be taken from the surfaces of the device in which i'
the foil is mounted or stored on which one might expect contamination to acctznulate.
Records of leak test results shall be kept in units of microcuries and maintained for inspection by the l
Depa,.w ant..
I C.
If the test reveals the presence of 0.005 microcurie or more of rem wable contamination, the licensee shall i M iately withdraw the foil from use and shall cause it to be decontaminated and repaired or to be. disposed of in accordance with 12 NYCRR 38.
A report shall be filed within five days of the test with the
' Chief, Radiological Health Unit, Division of Safety and Health, Ney York State Depart nent of Labor, 2 hbrld Trade Center, New York, New York 10047, describing the equipnent involved, the test results, and the corrective action taken.
D.
Tests for leakage and/or contamination shall be perfw.umd by the licensee or by other persons specifically authorized by the Department, State Departrent of Health, New York City Department of Health, U.S. Nuclear Regulatory Comnission, or other Agreement State to perform sud services.
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IV HYISOGEN 3 (1)
, A.
Individuals involved in operations which utilize, at any one time, nore than 100 mil 11 curies of Hyivge-n 3 in a non-contained form, other than metallic foil, shall have bi& =ays performed within one week following a singk operation and at weekly intervals for continting operations.
B.
(1)
Tritita shall not be used in such a manner as to cause any individual to receive a radiation exposure such that urinary excreticn rates exceed 28 microcuries of trititzn per liter when averaged over a calendar quarter.
(2)
Urinalysis shall be performed at weekly intervals on all individaals who work in the controlled areas of facilities in l '...
which tritita is used.
If the average ccocentration of tritita T~
in urine for any single individual during a calendar quarter
~
is less than 10 microcuries per liter, urinalysis may be performed on that individual at mothly intervals for the following calendar quarter and may continue at monthlyintervals so long as the average concentration in the calendar quarter remains below 10 microcuries per liter. te urine specimen shall be onllected on the same day of the week insofar as possible.
(3)
A report of an average concentration in excess of the limit specified in B. (1) above for any individual shall be filed, in writing, within thirty (30) days of the end of the calendar j
quarter with Radiological Health Unit, Division of i
Safety and Health, New York State Depaveit' of Iabor, 2 I
World Trade Center, New Yod, New York 10047.
S e report shall contain the results of all urinalyses for the individual l
during the calendar quarter, the cause of the excessive con-centrations, and the corrective steps taken or planned to assure against a recurrence.
l (4)
Any single urinalysis which discloses a concentration of greater than 50 microcuries per liter shall be reported, in writing, within seven (7) days of the licensee's receipt of
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the results to Radiological Health Unit, Division of Safety and Health, New York State Department of Labor, 2 World Trade Center, New York, New York 10047.
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(1)
Se licensee shall ocuply with the provisions of 12 NYCRR 38, "
ation Protection", including Appendix A " Specific requirenents for industrial radiwtathy", Section 38.41, 12 NYCRR 38.
(*)
S e individuals listed below are the only persons authorized by this license to act'as radiw apiers or radi% sat ers' assistants as defined i
in A.2 of Appendix A of Section 38.41, 12 NYCRR 38.
A.
Padi-f.at ers i
(i)
All individuals authorized to act as radigt piers pursuant to a valid license 4===d to the licensee by an Agreement State covering the uses and radinactive materials authorized by this license.
(ii)
B.
Radi%athers' Assistants
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(i)
All individuals authorized to act as radiographers' assistants pursuant to a valid license issued to the licensee by an AT&==i=nt State covering the uses and radinactive materials authorized by this license.
(ii)
(3)
A.
Pursuant to A.3(e), Appendix A. Section 38.41, 12 NYCRR 38, the licensee t
is authorized to perform tests for leakage or contamination of the sealed sources authorized by this license in accordance with procedures contained in B.
Notwithstanding the periodic leak test required by A.3(e), Appendix A, Section 38.41,12 NYCRR 38, such requirenent does not apply to radio-graphy sources that are stored and not being used. Se sources excepted fran this test shall be tested for leakage prior to any use i
or transfer to another person unless they have been leak tested within l
six months prior to the date of use or transfer.
l C.
Sealed sources authorized for a use other than radi%.pisy shall be tested as radiwtaehy sources in accordance with A.3(e), Appendix A, Section 38.41, 12 NYCRR 38.
l (4) te licensee is authorized to receive, possess, and use sealed sources of l
Iridium 192 or Cobalt 60 where the radioactivity excwds the maxinun I
amount of radioactivity specified in Ccndition 8 of this license provided:
1 A.
S,uch possession does not exceed the quantity per source specified in fondition 8 by nore than 20% for Iridium 192 or 10% for enhalt 60; B.
Records of the licensee diow that no nore than the maxinum amount of radioactivity per source specified in Candition 8 of the license was ordered fran the supplier or transferor o2. v.ne byproduct material; and
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%e levels of radiation for radiographic expsure devices and storage containers do not exceed those specified in A.3(a), Appendix A, Section 38.41, 12 PECRR 38.
(5)
W e radioactive materials shall be used by, or under the supervision of, qmlified licensee personnel designated by W e licensee shall maintain a current record of each person who has been qualified and has served as Radiographer and Radiographer's Assistant.
(6)
Re authorized place of use (is only, includes) tetporarf jcb sites of the licensee throughout the State of tk.w York. Se licensee shall notify this Department at least seven (7) days prior to using radioactive materials at such tenporary job sites.
(7)
S e licensy vis autho# -
to r
, pcssess, use transf to
/
ograms o anium contained shiel '
matKal in thydevices urce exchangers 1cens ein.
(8) t e licensee ~ radiation protection program manual specified in condition
, including a copy of the Code Rule shall be made avai]able to each person working with or having responsibility for sources of radiation pursuant to Section 38.34(b),12 INCRR 38.
W e operating and emergency procedures, including the inspection and maintenance of devices and storage containers shall be followed.
Any change in the manual affecting the radiation protection of persons shall be subnitted to this Depart:nent for license amerdnent prior to issuanm to personnel.
One (1) curie of Iridiun 192 is defined as that quantity of radioactivity which prrvhm an intensity of 0.55 roentgens / hour at one (1) meter fran the source.
/.
/ VI GMt% IRRADIATOR9 (1)
A.
Each sealed source containing r.vHmetive mataterial shall be tested for leakage and/or contamination at intervals not to exceed six nonths.
In the absence of a certificate frun a transferor indicat-ing that a test has been made within six nonths prior to the transfer, the sealed source shall not be used until tested.
B.
%e tests shall be capable of detecting the presence of 0.05 micro-curie of contamination on the test sanple.
%e test sanple shall be taken fran apprcpriate accessible surfaces of the device in whirA the sealed source is permanently or senipermanently nounted or stored.
Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Department.
C.
If the test reveals the presence of 0.05 microcurie or nere of retovable contamination, the licensee shall inmediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with 12 NYCRR 38.
A report shall be filed within five days of the test with the Olief,, Radiological Health Unit, Division of Safety and Health New York State Department of Iabor, 2 World Trade Center, N'w York New York 10047, describing the eouipement involved, the test results, and the corrective action taken.
D.
Tests for leakagae and/or contamination shall be performed by or by other persons specifically authorized by the Department, New York State Department of Health, New York City Department of Health, U.S. Nuclear Regulatory Ccm-mission, or other Agreement State to perform such services.
(2)
Written instructions shall be followed and a ccpy of these instructions shall be made available to each individual using or having responsibility for use of radioactive material.
Any changes in thesp instructions shall have the prior approval of the Chief, l
Radiological Health Unit Division of Safety and Health, New York State Department of Iabor,2 World Trade Center, New Yo&, New York 10047.
(3) he procedures ccntained in AECL's instruction manual for the "Gammacell
" device shall be followed and a ccpy of this manual shall be made available to each person using or having responsibility for the use of the radioactive material.
(4) t e licensee is authorized to relocate, store, and install source units containing radioactive material licensed above and to perform r.cintenance and rep:ir of the units which does not involve exposure of sealed sources.
Replacenent. And disposal of sealed sources co6tainizia radioactive rhaterial shall be performed only by persons specifically authorized by the Department, New York State Department of Health, New York City Department of Health, U.S.
Nuclear Regulatory Cmnission, or other Agreement State to perform such services.
/
(5)
After installation of the irradiator and Cesiun 137 or Cobalt 60 source and prior to initiation of the irradiation program, a radiation survey shall be conducted to determine the maximum radiation levels in each adjoining the irradiation rocm. A detailed report of the results of this survey shall be sent to the Chief, Radiological Health Unit, Division of Safety and Health, New York State Department of Iabor, 2 World Trade Center, New York, I W York 10047, not later than thirty days following installation of une source.
(6)
After installation of the irradiator and Cesiurn 137 or hit 60 source and prior to initiation of the irradiation program, a radiation survey shall be conducted to Jetermine radiation levels around, above, and below the irradiator with the source in the irradiate position ard with the source in the shielded position. A detailed report of the results of the surveys shall be sent to the Chief, Radiological Health Unit, Division Safety and Health, New York State Department of Iabor, 2 World Trade Center, New York, New York 10047, not later than thirty days following installation of the sCurce.
(7)
'Ihe licensee shall notify this Department at least seven (7) days prior to the the initiation of any irradiator installation and source replacanent
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authorized in this license.
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. VII GENERAL LICD2SE DISTRIBUTION AND CERTAIN SEMrn SOUIrFR AND DEVICES M
(1)
We licensee is not authorized to repair, nodify, dismantle, or affect any change in the gauges manufactured by the
.%e licensee is not authorized to modify or alter labefs affixed to the gauge by the in accordance with the terms and conditions of the licenses authorizing manufacture of the gauge except where a change in the leak test interval for the gauge has been authorized or when a generally # licensed gatge is converted to a specifically licensed status.
(2)
Foil containing radioactive material shall not be reaved frm the device.
(3)
No generally licensed device shall be installed by the licensee in such a manner or in such a location that any person could receive more than 0.5 rem in a calendar year under ordinary circumstances of use.
(4) he licensee shall furnish to each general licensee to whcm it
. transfers a generally licensed device a copy of Item (b), Table 3, Section 33.41, 12 NYCRR 38.
(5) hsts of sealed sources for leakage or contamination shall be in acmrdance with the following:
A. S e conditions of pertinent licenses issued by the Department, the State Department of Health, the NW York City Department of Health, the U.S. Nuclear Pegulatory Ccnmission, or other Agrement State authorizing the custcmer's use and possession of the radioactive material; B. me procedures described in the application filed by and dated
.o C. We sealed source shall not be removed frcm the device. hsts shall be made with the sealed source in the shielded or off condition; I
D Prior to mllection of test sanples, the-tester shall survey the area which he will occupy during the sample collection; and E. A report of the results of each test shall be provided the cus-tener in units of microcuries.
i n
(6)
After installation by the licensee of each device distributed to persons general-ly licensed pursuant to Iten (b), Table 3, Section 38.41, 12 NYCRR 38, the licen-see shall conduct a radiation survey and shall assure that the levels of radiation do not exceed those specified in the license authorizing the manufacture or dis-tribution of the installed gauge. 'Ihe licensee shall furnish the general licen-see a ocpy of the radiation survey report.
(7)
'Ihe handling of radioactive material under this license in the manufacture, ins-tallation, dismantling, relocation, and testing of devices shall be performed by (8)
'Ihe licensee shall test each device distributed under this license for leakage or contamination of radioactive material and proper cperation of the "on-off" mechanism and indicator, if any, at the time of installation of the device.
(9) A. Each device distributed under this license shall bear a durable, clearly visible and legible label or labels cantaining the statements:
1.
" Receipt, possession, use, and transfer of this device are subject to a general license or equivalent and regulations of the U.S. Nuclear Regulatory 02nnission or an Agreement State."
2.
" Abandonment or disposal prohibited unleastransferred to persens specifical-ly licensed by the Nuclear Regulatory Otmnission or an Igreement State."
3.
" Operation prohibited if there is indication of failure of or damage to shielding, source containment or on-off mechanism."
4.
" Installation, dismantling, relocation, maintenance, repair and testing in-volving the radioactive material, its shielding or contair: ment shall be per-formed by persons specifically licensed by the Nuclear Regulatory Cm mission or an Agreement State."
5.
" Device shall be tested for radioactive leakage and proper functioning of on-off mechanism and indicator, if any, at installation, at source replace-mnt*, and thereafter at no longer than intervals."
6.
"Ioss, theft, or transfer of this device and failure of or damage to the shielding, the source containment or the on-off mechanism must be reported to the Nuclear Regulatory Q2nnission or an Agreerent State."
l B.
Each device distributed under this license shall bear a durable, clearly visible and legible label or labels containing the device nodel ard serial number, the radiation symbol in colors magenta or purple on a yellow background, the wrds, "CAUTIQi, PADICACTIVE MATERIAL" or " DANGER, PADICACTIVE MATERIAL," the ciuantity, identity and date of measuremnt of the radioactive material, and the name of
'the distributor of the device.
I C.
Each label required by this condition shall bear the statsnent, " Removal of this label is prohibited."
1 l
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- (10)
'A.
W e licensee shall report to the Chief, Radiological
-lth Unit, Division of Safety and Health, New York State Departne of labor, 2 World Trade Center, Nea York, New York 10047, all transfers of devices distrbuted under this license to persons generally licensed under Itan (b), Table 3, Section 38.41, 12 NYCRR 38.
Such report shall identify each general licensee by name and address, the type of device transferred, the quantity and type of radioactive material contained _
in the device, and the specific location where each device is installed.
We rcport shall be subnitted within 30 days after the end of each calendar quarter in which any such device is transferred to a generally licensed person.
B.
'Iha licensee shall report to the chief, Radiological Health Unit, Division of Safety and Health, New York State Depart 2nent of Labor, 2 World Trade Center, New York, Nea York 10047, all transfers of devices distributed under this license to persons generally licensed under Item (b), Table 3, Section 38.41, 12 NYCRR 38.
Such reports shall identify each general licensee by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device.
me report shall be subnitted within 30 days after the end of each calendar quarter in which any such device is transferred,to a generally licensed person.
(11)
Demonstrate, install, relocate, maintain, and test galging devices manufactured by the Cbrporation under the provisions of Itan (b), Table 3, Section 38.41, 12 NYCRR 38, for distribution to persons generally licensed or equivalent provisions of the regulations of the U.S. Nticlear'Rcgulatory Ctzmttssion or other Agrem ent State.
(12)
We licensee shall not transfer possession and/or control of radioactive material or products containing radioactive material as a contaminant except:
1 A.
By transfer of waste to an authrorized recipient; B'.
By transfer to a specifically licensed recipient; or C.
As provided otherwise by specific condition of this lice;.se pursuant to the requiremnts of Exe1ption 2, Table 1, Section 38.41, 12 NYCRR 38.
(13)
Installation, relocation, maintenance, repair, and ini'.ial radiation survey of devices containing radioactive material and leak testing, installation, replacement, and disposal of sealed rources containing radioactive material used in devices shall be performed only by
, or by other persons specific-ally authorized by the Department, U.S. Nuclee.r Ec<;ulatory Ccmnissicn, or other Agreenent State to perform such services.
~,.
(14)
Installation, relocation, maintenance, repair, and initial radiation survey of devices containing radioactive material and installation, replacment, and disposal of sealed sources containing radioactive material used in devices shall be perfomed only by or by other persons specifically authorized by the Decartment, the U.S. Nuclear Regulatory Ctumission, or other Agreement State to perform such services.
i (15)
Maintenance, repair and initial radiation survey of devices containing radioactive material and leak testing, installation, replacment, and disposal of sealed sources containing byproduct material used in devices shall be performed only by by other persons specifically authorized by the Department, the U.S. or Nuclear Regulatory Cbnmission, or other Agrement State to perform such services.
(16)
We licensee shall not open and/or repair sealed sources or reove sealed sources frcm their respective source holders and/or devices.
4
-. - ~ j + 7 (17)
We licensee is not authorized to repair, nodify, diinnantle or affect any changes in the sosirce holders and/or devices nor nodify or alter labels -
affixedthereto except as otherwise approved by this Departnent.
YII CIVIL DEFENSE (1)
Each sealed source containino licensed material to be used outside of a shielded exposure device shall have a durable, legible, and visible tag permanantly attached by a durable ring. We tag shall be at least one (1) inch square, shall bear a conventional radiation synbol prescribed in Section 38.31(a) of 12 NYCRR 38, and a minimum of the follcwing instructions:
DANGER-RADIOAC.TIVE fGTERIAL DO NOT HAhTLE-NorIFY CIVIL AU1EORITIES IF EDUND.
Replacement of tags and rings shall be carried out by the licensee in accordance with instructions contained in PPOCEDURES AND REGUIATIGE E1DR 'IHE CARE AND USE OF THE CCD CD V-778 RADIATICN TRAINING SOURCE SET, dated February 1967.
(2)
A.
Byproduct material contained in DCPA Sealed Source Sets shcIl be tested for external leakage and/or contamination upon receipt frcm another person, except when the licensee receives certification fran the person that the sources had been tested within six (6) nonths prior to transfer and found free of surface contamination.
mereafter, sources shall be tested for leakage and/or centamination at intervals not to exceed six (6) nonths.
Records of leak test results shall be maintained by the licensee.
B.
We test for leakage and/or contanunation shall be capable of detecting the presence of 0.0,5 microcurie of radioactive material on the test sample.
l l
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C.
If the test reveals any radioactive material, the licensee shall take ir: mediate action to prevent spread of contamination and within five (5) days after empletion of the test shall notify the 011ef, Radiological Health Unit, Division of Safety and Health, New York State Department of Labor, 2Etli Trade Center, New York, New York 10047.
D.
Ieak test of sealed sources in DCPA Sealed Source Sets shall be performed by the licensee in accordance with instructions contained in PROCEDURES AND REGUIATICNS EUR M CARE AND USE OF M OCD, CD V-778 RADIATION TRADOKi SOURCE SET, dated February 1967.
(3)
Byproduct material shall be stored except for tesipwary storage at locations where trauung courses are conducted.
W e
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'VIII TE m1HERAPY O mnent While the Radiological Health Unit does not license the use of teletherapy units by physician, it is responsible under 12 NYCRR 38 for licensing the installation of such units in hospitals, clinics and physician's offices.
Werefore, license cxanditions pertinent to installation are included.
(1)
A.
Teletherapy sources shall be tested for leakage at intervals not to exceed six nonths.
Ew.ais of test results shall be kept in units of microcuries and maintained for inspection by the Industrial rh =issioner.
In the absence of a certificate frcm a transferor indicating that a test has been made within six nonths prior to the transfer, the source shall not be used until tested for leakage.
B.
W e tests shall be sufficiently sensitive to detect 0.05 micro-curie of contamination on the test sanple.
C.
%e test sanple shall be taken from selected accessible surfaces of the teletherapy head. % e selected accessible surfaces should be those surfaces on which one might expect contamination (if there were to be leakage) to accumulate and shall include the inner surface of the nest frequently used treatment cones or beam m111 mating device. We test sanplo shall be taken with the source in the "off" position.
D.
If the test reveals the presence of 0.05 microcurie or nore of renovable contamination, the licensee shall prtmotly take action to prevent spread of contamination and shall file a report within five days of the test with the Chief, Radiological Health Unit, Division of Safety and Health, New York State Department of Labor, 2 World Trade Center, New York, New York 10047, describing the test results and the corrective action taken.
~(2)
Prior
- to initiation of a treatment program, each teletherapy unit shall be equipped with electrical or mechanical stops limiting use of the primary beam of radiation so as to assure czmpliance with subdivision 38.22 (a),12 NYCRR 38, as evidenced by a radiation survey.
Necessary use restrictions shall be fully described in radiation survey reports submitted in accord-ance with (3)
A written instruction shall be posted at the teletherapy machine mntrol.
mis instruction shall inform the machine operator of the procedure to be followed should he be unable to turn the madtine's primary beam of radiation "off" with the controls outside the treatment room.
'Ihese instructions shall caution individuals to avoid exposure to the primary beam of radiation when in the treatment rocm and shall include specific instructions for:
A.
Iocating and using the device for manually turning off the teletF Py unit's primary beam of radiation.
s
f B.
Removing the patient fran the treat:nent 5xx2n.
C.
Securing the rocm against unauthorized entry.
D.
Notifying the responsible physician or radiation protection officer.
(41. A.
Access to the telethera y recrn shall be controlled by a door at each entrance. Such doors shall be normally closed.
B.
Each entrance to the teletherapy room shall be equipped with an electrical interlock system that will turn the teletherapy machine's primary beam of radiation off imnediately upon opening of any entrance door. W e interlock system shall be connected in such a manner that the teletherapy machine's primary beam of radiation cannot be turned on until all treatznent roan entrance doors are closed and the beam "on-off" control is reset at the control panel.
C.
Electrical interlocks on entrance doors to the teletherapy roon shall be tested for proper operation at least once every six months.
Records of test results shall be maintained for inspection by the (insert appropriate regulatory body).
D.
In the event of malfunction of any door interlock, the teletherapy machine control shall be locked in the "off" condition and not used, e. w t as may be necessary to repair or replacment of the interlock systen, until the interlock system is shcun to be functioning properly.
45)
Prior to initiation of a treatment program, and subsequent to each installation of a teletherapy source, radiation surveys and tests shall be performed in accordance with the following:
A.
A radiation survey shall be made of:
(i) he teletherapy source housing, with the teletherapy source in the
','off" position. %e maximtrn and average radiation levels at one meter frcm the telettieraby source in the "off" position shall not exceed 10 millircentgens per hour and 2 milliroentgens per hour, respectively.
(i'i) All areas adjacent to the treatment rocm with the teletherapy source in the "on" position. We survey, except Item (c), shall be performed with a phantcm in the primary beam of radiation and shall clearly establish:
(a) mat radiation levels in controlled areas are not likely to cause personnel exposure in excess of the limits specified in subdivision 38.21 (a),12 NYCRR 38.
(b)
Wat quantities of radiation in uncontrolled areas do not exceed the limits specified in subdivision 38.22 (a),12 NYCRR 38.
l
[
(c) he intansity of the primary beam of radiation at a specified distance frm the teletherapy source.
B.
Tests shall be made to determine proper operation of:
(i)
Electrical interlocks or, entrance doors to the teletherapy treat-ment rocm.
(ii) ne teletherapy source "or.-off" irdicators, both at the source housing and on the teletherapy machine control panel.
(iii) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel, and operation of the beam "on-off" mechanism).
(iv)
%e teletherapy treatment timing device.
C.
A report of the results of the above surveys and tests shall be sent to the Gief, Radiological Health Unit, Division of Safety and Health,, Nee York State Department of Iabor, 2 World Trade Center Nee York, New York, 10047, not late,r than thirty days following each installation of a teletherapy source.
(6) Any changes made in treatment room shielding,1ccation, or use of the teletherapy machine which could result in an increase in radiation levels in unrestricted areas outside the teletherapy treatment rocm and made subsequent to the ccrrpletion of the initial radiation survey performed in accordance with shall be evaluated by a radiation survey made.in accordance with Itcm A.
(ii) of A report describing the change (s), and giving the results of the survey (s)'shall be sent to the Chief, Radiological Health Unit, Division of" Safety and Health, New York State Department of Labor, 2 terld Trade Center, New York, Nee York 10047.
(7) ne licenree is authorized to install in his facility the teletherapy unit specified in Item 9.A. loaded with a sealed source as described in Item 6, 7, and 8 of this license. S e installation shall be in accordance with the procedures, reu-erdations, and suggestions contained in and shall be conducted by the local service organization under the supervision of Deviations frcm the foregoing shall have the prior approval of the Gief, Radiological I
Health Unit, Division of Safety and Health, New York State Department of labor, l
2 World Trade Center, New York, New York 10047.
(8) ne licensee is authorized to possess, use, transfer, and inport the uranium i
contained as shielding material in the teletherapy units authorized by this license.
(9) Each teletherapy machine shall be fully inspected and serviced during source re-placement or at intervals rot to exceed five (5) years, whichever cmes first, to assure proper functioning of the source exposure mechanism.
Eis inspection and se.rvicing must be performed by persons specifically authorized to do by the Industrial. Ccrmissiorm;$he U.S. Nuclear Regulatory Ommission or an Agrement State State, and a report of the inspection and servicing must be kept on file for review by the Departnent.
(10).
Pursuant to Section 38.9 of 12 NYCRR 38, the licensee is authorized to :
receive, possess, use, and transfer the uranium contained as shielding -
material in the teletherapy units authorized by this license.
(11)
Se radie*-tive materials may only be used at the sites of custmers in this state who possess valid radioact.ive materials licenses for the source issued'by this Department, the New York State and New York City Departments of Health.
te licensee shall notify this Department at least seven (7) days prior to the initiation of any teletherapy unit i
installation anddismantling authorized in this license.
(12) he licensee in hereby authorized to perform the 5 year inspection and maintenance servicing on teletherapy units in accordance with procedures submitted with letter dated
, signed by (13)
S e licensee is hereby au l. sized to perform leak tests on the sealed sourcerlicensed in Conditicr a 6, 7, and 8 during installation or servicing 6f the teletherapy units as authorized in Condition We leak tests shall be in accordance with the leak test condition of the custcmer's license. Such test shall satisfy the leak test requirenents of the..
custmer's license, provided that the customer is supplied the results of the leak test in microcuries and advised of the requirenents for renoving frm service the device containing the sealed sources and wi.ing the results to this Department if the leak test reveals contamination in excess of that specified by his license.
(14) he following shall be performed cnly by persons specifically authorized by the Department, the U.S. Nuclear Regulatory Camission, or an Agreement State to perform such services:
A.
Installation, relocation, or remaval of teletherapy units containing sources.
B.
Source exchange.
C.
Any maintenance or repair operations on a teletherapy unit involving work on the source drawer, the shutter, or other mechanism that could expose the source, reduce the shielding around the source, or caprmise the safety of the unit and result in increased radiation levels.
i l
i
IX MEDICAL APPLICATIONS CONENT - Sczne of these license conditions nry be pertinent for radio-pba m utical firms.
(1)
'Ihe licensee shall not use radioactive matarial in or on human beings or in field applications where activity is released ex-cept as provided otherwise by specific condition of this license.
(2)
Dperimental animals administered radioactive materials shall not be used for hunan constmption.
(3)
Radioactive material shall not be used in or on human beinas ' -
or in products distributed to the public.
(4)
A.
Except as otherwise specifically provided by this license, radioactive material to be administered to humans shall be procured in prepackaged, precalibrated form fran a supplier who manufactures or repackages the product under appu.yriate pharmaceutical controls related to assay, identity, quality, purity, sterility, and nonpyrogenicity.
B. Radoactive material prepared by the licensee may be used in humans, provided the product is produced under pharmaceutical controls related to assay, identity, quality, purity, sterility, and nonpyrogenicity in accordance with (5)
Needles or standard medical applicator cells containing Cobalt 60 as wire shall not be opened by the licensee unless specifically authorized by a condition in this license.
(6)
A. Iodine 131 labeled Macroaggregated Iodinated Human Serun Albumin shall be procured fran a supplier who holds an unsuspended or unrevoked license issred by the Secretary, Depart: ment of Health, Education, and Nelfare, to prcpagate or manufacture and prepare, label, or distribute this material pursuant to 42 CER 73,
" Biological Products."
B. Chronium 51 labeled Human Serun Albumin shall be procured fran I
a supplier who holds an unsuspended or unrevoked license issued by the Secretary, Department of Health, Education, and Welfare, l
to propagate or manufacture and prepare, label, or distribute l
this material pursuant to 42 CE'R 73, " Biological Products."
1 C. Technetium 99m Petechnetate may be eluted and prepared fran a Molybdenum 99/Technetiun 99m generator in accordance with statements, reEresentations, and procedures contained in l
(
D.
Iodine 131 labeled 0311oidal (Microaggregated) Hunan Serun Albunin shall be procured frcrr. a supplier who holds an unsusperded or unrevoked license issued by the Secretary, Department of Health, Education, and Welfare, to propagate or manufacture and prepare, label, or distribute this material pursuant to 42 CFR 73, " Biological Products."
E.
Technetiun 99m labeled sulfur colloid preparations which appear flocculent or aggregated shall not be used in humans.
F.
Technetium 99m labeled sulfur colloid shall be procured and/or prepared in accordance with statenents, representations, and procedures contained in G.
Iodine 131 as iodinated' human serum albumin for use in cisternography shall be procured fran a supplier who holds an unsuspended or unrevoked license issued by the Secretary, Department of Health, Education ard Welfare, to prcpagate or manufacture and prepare, label, or distribute IHSA for cisternography pursuant to 42 CFR 73, " Biological Products."
H.
Technetiun 99m lab'eled iron-ascorbate-diethylenetriamine pentaacetic acid ccmplex shall be procured and/or prepared in accordance with statenents, representations, and procedures contained in
_CmMENP Standard Cbnditions for Technetium 99m Labeled Albunin Microspheres (Human) for Lung Imaging.
I.
Technetium 99m labeled albunin microspheres (human) for lung imaging shall be procured and/or prepared in accordance with statements, re-presentations, and procedures contained in l
J.
Technetiun 99m labeled albumin microspheres (human)
(or connercial kits) l used to prepare the products shall be procured fran a supplier who tolds an unsuspended or unrevoked license issued by the Secretary, Department of Health, Education, and Welfare to propagate or manufacture and prepare, label, or distribute the material for the purpose of lung imaging pursuant to 42 CER 73m " Biological Products."
m
f
~,
X PIDIONILM ALPHA SOURCES (1)
'Ihe sources when not in use shall be stored in a closed container ade-quately designed and constructed to contain plutoniun which might otherwise be released during storage.
(2)
At least once every three nonths the licensee shall test the source for loss of plutonium in one of the following ways, using radiation detection instrunentation capable of detecting 0.005 microcurie of alpha cantanination:
(a)
By measurement of the source or alpha surveys of the storage cxmtainer and areas in which the source is used; or (b)
By wiping thoroughly the external surfaces of the source nount, other than the radioactive surface of the source, with a piece of filter paper of high wet strength and low porosity noistened with a solution which will not attack the mount and, after the paper is allowed to dry, measurina the radioactivity on the paper.
(3)
If any survey of measurenent performed as required by 2. (a) or 2. (b) above, discloses the loss of nore than 0.005 microcuries of plutonium from the source, or if a source has been damaged or broken, the source shall be deemed to be losing plutoniun.
The licensee shall i==Hately withdraw it fran use, and cause the source to be deccntaminated and repaired, or disposed of in accordance with provisions of 12 NYCRR 38.
Within five (5) days after determining that any source has lost.
plutonium, the licensee shall file a report with the Chief, Radiological Health Unit, Division of Safety and Health, New York State Department of Iabor, 2 ?Jorld Trade Center, New York, New York 10047, describing the source, the test results, the ement of contamination and the corrective action taken.
(4)
Records of test results shall be kept in units of microcuries and maintained for inspection by the Department.
(5)
Notwithstanding the periodic test required by License Condition 2, any plutonium alpha source containing not nore than 0.1 microcurie of plutoniun is exanpted frcm the above requirenents.
(6)
Except for plutoniun contained in a medical device desicned for irtlividual hunin gplication, no plutonium, regardless of form, shall be delivered to e carrier for shipnunt by air transport or transported in an aircraft by the licensee.
(7)
A.
Each encapsulated plutonium source designed for the purpose of enit-
~
ting neutron or ganma radiation shall be tested for leakage at intervals not to exceed six (6) months.
In the absence of a certificate frcm a transferor indicating that a test has been made within six (6) nonths prior to the transfer, the sealed source shall not be put into use until tested.
,l
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B.
%e test shall be capable of detecting the presence of 0.005 micro-l c2ie of alpha ecmtamination of the test saple. %e test saple shall be taken fran the source or fran appropriate accessible surfaces of the device in which the sealed source is pemanently or semipermamanently nounted or stored. Records of leak test results shall be kept in units of microcuries anr1 maintained for inspection by the Department.
C.
If the test reveals the presence of 0.005 microcurie or nere of re.
movable alpha contamination, the licensee shall inmediately withdraw the sealed source fran use and shall cause it to be d-Aaminated and repaired by a person appropriately licensed to make such rapairs or to be disposed of in accordance with the regulations. Within five (5) days after deternining that any source has leaked, the licensee shall file a report with the Chief, Radiological Health Unit, Division of Safety and Health, New York State Department of Labor, 2 World Trade Center, New York, New York 10047, describing the source, the tect results, the extent of contamination, the apparent or suspected cause of source failure, and the corrective action taken.
D.
Se pertiodic leak test required by this condition does not apply to sealed sources that are stored and not being used.
Se sources excepted fran this test shall be tested for leakage prior to any use or transfer to anothar person, unless they have been leak tested within six (6) nonths prior to the date of use or transfer.
E.
Notwithstanding the other provisions of this leak test condition, leak tests are not required on pacemakers inplanted in experimental animals provided that a leak test shall be performed inmediately following renoval of the pacemakers fran the anianals.
XI TRANSPORTATION We following cordition is to be used in licenses where the licensee (not a comon or contract carrier under regulations published by the Department of Transportation or U.S. Post Office) wants coverage for transportation of radiois*otopes because his transportation does not occur in interstate or foreign connarce or the traansportation is.by air in other than civil aircraft.
(1)
W e licensee may transport license <' material or deliver licensed material to a carrier for transport, in accmbre with the provisions of Section 38.39, 12 NYCRR 38.
O
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'j a d,A b/
Revision f 2 3-15-78 TABLE 1
~
Priority Classification by Category Priority # 1
()
Source Code
=
A Waste burial grounds (84)(86) n Waste disponal services (84)(86)
C Manufacturer of generally (80) (81) (32) (83) (84) licensed devices D
Major processors manufactures and distributors of
( 7)) ( 7 7) ( 71) ( 7 5) ( 7 8) radioactive material products ( possession limit (79) (80) (81) ( 82) ( 83 )
greater than 0.5 Curie)(except saaled light sources (gg) in finished products)
E Scaled gamma radiographic' sources (70)
F Scaled irradiation sources (1 Kilocurie (71) or greater)
.,yPriority # 2 11 Neutron generators (24)
I Static climinator bars (specifically licensed)
(40) (41)
J Radioactive ma terial gauging devices not other -
(50) (5 3) (5 4) (5 5 ) (5 9 )
wise specified (specifically licensed)
(60) (61) (62)
K Sealed irradiation sources (less than 1 Kilo-(71) curic)
L Scaled special nuclear material sources (75)
H Scaled radioactive material sources used in R& D (72)(73)(76)
MM Scaled RAM not otherwisc itemized
( 7 8) ( 7 9 )
M Unscaled radium and daughter products (80) 0 Unscaled source material (31)
P Unscaled radioactive material used in R &D (82)(89) otherwise,itemiEcd (except on timepieces)
(82)(89)
PP Un, scaled RAM not 5.
1 Q
Unscaled special nuclear material sources (83)
R Tc1ctheraphy service (91) f$5.1('I b
I
.o I
j t
.l.
- f '
p i
I S
Other radioactive material sales or servicat not otherwise ;
(99) specified i
[
i 1.
I, Priority # 3 i
i
?
I i
T Air Ionizers (42)
- ?' #p
.)
l U
Cas Chromatographs (57)
..)
{
I p
(
4-
.ei
(
V Sealed calibration sources
,72)
I p-(
I W
Sealed ionization or excitation sources!
(1 3) l i
(85h l
X Unsealed radioactive material on timep:.cceo f
l Y
Leak testing service (92)(93) c x
Z Humidity, gauges (51) j
[
I AA */acuum gaur,es (specifically licensed)
(52D l
i BB Static meters (specifically licensed)
(43:
i
}'
1 l
CC Scaled li r,h t sources (74)
!i i
e
(.
riority # 4 I
i Cencrally licensed gaunes f
Generally licensed static eliminator bars (regi t e r ra. '
I Other generally licensed and registered source:p not c.
e specii I.
Ionizinr, radiation equipment (registered)
I c
e f
- 4 s
e*
6 A
A
APPENDIX I REVIEW OF SELECTED LICENSE FILES 1.
Licensee:
West Seneca Developmental Canter Address:
West Seneca, NY License Number:
2297-3106 Date of Issuance:
Aug. 10, 1981 Expiration Date:
Dec. 31, 1984 License Type:
Level Gauge 2.
Licensee:
Wassaic Developmental Center Address:
Wassaic, NY License Number:
2299-3111 Date of Issuance:
Aug. 18, 1981 Expiration Date:
Dec. 31, 1984 License Type:
Level Gauge 3.
Licensee:
General Electric Company Address:
Niskayuna, NY License Number:
794,-0220 Date of Issuance:
Nov.18,1966 (original)
Expiration Date:
April 30, 1984 (18 amendments)
License Type:
R&D 4.
Licensee:
Schwartz /Mann, Becton Dickinson Immunographics Address:
Orangeburg, NY License Number:
273-0811 Date of Issuance:
June 6, 1972 (original)
Expiration Date:
Jan. 31, 1984 (13 amendments)
License Type:
Radioimmunoassay 5.
Licensee:
Seismograph Service Corporation Address:
Tulsa, OK License Number:
962-0278 Date of Issuance:
Aug. 2, 1972 (Amend. #3)
Expiration Date:
Oct. 31, 1981 (under renewal)
License Type:
Well Logging 6.
Licensee:
Nuclear Radiation Development Address:
Grand Island, NY License Number:
1398-1811/1391-1811/1429-1811 Date of Issuance: Dec. 21, 1979 (Amend #21)/ July 15, 1981 (Amend #20)/
July 16, 1980 (Amend #12)
Expiration Date:
July 31, 1984/ July 31, 1982/ July 31, 1981 License Type:
Broad Industrial / Leak Testing / General License 7.
Licensee:
Sigma Laboratories Address:
E. Elmhurst, NY License Number:
2293-2220/2223-2220/2110-2220 Date of Issuance:
June 23, 1981/ Sept. 27, 1979/ Sept. 10, 1975 (original)
Expiration Date:
Oct. 31, 1984/0ct. 31, 1981/Oct. 31, 1984 License Type:
R&D/GL/Auth. Leak Tests
I-2 8.
Licensee:
Self-Powered Lighting, Ltd.
Address:
Elmsford, NY License Number:
1308-1611 Date of Issuance:
Jan. 1, 1980 Expiration Date:
Oct. 31, 1981 License Type:
Manufacture and Distribution 9.
Licensee:
Technicon Instruments Corp.
Address:
Terry Town, NY License Number: 22#5 -2178 A277 - 2M8 Date of Issuance:
Mar, 16, 981 (renewed)
Expiration Date:
Oct. 31, 1982 License Type:
GL/Invitro Radioimmunoassay 10.
Licensee:
Barrett Paving Materials Inc.
Address:
Utica, NY License Number:
2294-3102 Date of Issuance:
June 26, 1981 Expiration Date:
Jan. 31, 1984 License Type:
Gauge 11.
Licensee:
Trutan (US) Ltd.
Address:
Latham, NY License Number:
2291-3100 Date of Issuance:
June 5, 1981 Expiration Date:
Oct. 31, 1984 License Type:
Industrial Radiography 12.
Licensee:
Mica Radionuclear Instruments, Inc.
Address:
Bronx, NY License Number:
2252-3034 Date of Issuance:
April 26, 1981 Expiration Date:
July 31, 1983 License T9pe:
Service (installation of teletherapy units) l
s I-3 i
License files Coments 1
2 3
4 5
6 7
8 9
10 11 12 1.
Not sufficient detail or not operating and emergency procedures x
x 2.
Renewal in entirety is recomended x
x x
x 3.
Not sufficient detail or no procedures for receipt transfer of radioactive materials x
x x
4.
No training procedures in application x
5.
Outdated Health Physics Manual x
x x
6.
Leak test procedures questionable x
x 4
1 i
l SPECIAL REVIEW Radium Chemical Company, Inc.
L-0120 l
Original New York license issued October 1,1964.
The license is currently up i
for renewal.
The license authorizes the manufacture of tritium and promethium j
compounds.
The radium and radon is registered, but was never put on the l
license.-
On July 30 and 31, 1980, the last full inspection was performed by L. Cabasino 1
and R. Kelley.
Eighteen items of noncompliance were found:
(1) inadequate l
personnel monitoring record keeping, (2) two film badges being used by one i
person, (3)-(6) other personnel monitoring records problems, (7) smoking in j
hood area, (8) reduced flow in tritium hood (inadequate), (9) no inventory on receipt and sale of radium, (10) smoking in area with surface contamination, (11) pocket dosimeters not being used, (12) survey meters not calibrated.
(13) no records of survey meter calibration, (14) no determination of radio-activity discharges into air, (15) whole body scans overdue on all employees, (16) no written instructions on shipment and receipt of radioactive material, (17) six overexposures-whole body for 1979, and (18) excessive-radon airborne 4
concentrations.
The licensee was given until August 31, 1980 to respond.
The report included extensive independent measurement results.
The report was i
hand written and it was difficult to follow and find adequate support for the items of noncompliance.
At the time of.the inspection the company was manu--
facturing Rn seeds, tritium compounds, and radium needles.
The report covered i
the following areas:
Administrative Information, Radiation Protection Program (including personnel monitoring, surveys, calibration, environmental monitoring, training, posting, records, and transportation), independent measurements, and comments.
In the comments section, the inspectors stated that the company has a small staff, therefore the exposure " load" for each is high.
The main i
problem appeared to be the radon pump room.
j On August 21, 1980, the state notified the company that their radon samples l
indicated that concentrations in the pump room were 100 times MPC.
They stated that these values represented an imminent hazard and that unless corrected immediately they would " tag" the pump room and not permit anyone to enter except for emergency service on the radon pump.
On September 19, 1980 the state made a follow-up visit to the company to take additional air samoles.
At that time, two additional items of noncompliance were cited:
(1) exhaust t
3 vents not working and air samples for radium of 9/17 over MPC.
l On October 24, 1980, the licensee submitted a proposal to construct a hood over the radon pump and install charcoal filters in the duct system.
The State responded on October 31 stating that the company should submit specific plans for approval prior to making any alterations to the facility.
In the meantime, on October 28 another visit was made to the site to take more samples.
The inspector indicated that the company has not been fully cooperative and l
that continued hazards are prevalent.
i L
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,-,-..,,,vv.-
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SR-2 On February 5,1981, the state issued an " Order to Comply" to the company to remove and dispose of the 2.9 Ci of radium in the radon pump and to decon-taminate the pump room to specified limits.
A compliance date of March 9 was set.
On March 2 the company requested on extention to April 15 and that rather than dispose of the radium, install an exhaust system to eliminate the problem.
The State issued a modified order extending the compliance date to April 15,1981.
However, four conditions were specified:
(1) each person entering the cump room shall wear a radon monitoring detector, (2) the pump room exhaust shall be checked for compliance with applicable MCP limits, (3) biweekly progress reports shall be provided on the " ventilation plans, installing a new pump and disposing of one gram of Ra-226, and (4) evaluation of progress by their HP consultant.
At the licensee's request, the State later extended the deadline to May 1.
Apparently no action of correspondence took place until an inspection was performed on July 2, 1981.
During that inspection continued overexposures were noted as well as other serious items of noncompliance.
The inspector determined that little had been done to comply with the order.
An enforcement letter was sent on July 6 stating that the company has failed to respond in writing to any items of noncompliance noted since August 1980 and that addi-tional violations had been discovered.
Also on July 6 the State issued another order which was essentially identical to the February 5,1981 order.
This time the licensee was given until July 15 to comply.
In the meantime, the State was informed that the company was shipping radon to unlicensed customers.
This was brought to the company's attention in a letter dated July 9, 1981.
Also on July 9-10 a follow-up inspection was performed.
Again, radon exposures were above regulatory limits, surface contamination in uncontrolled areas was above limits, and no records were kept on stack monitoring.
In addition, there was a release of 1.5 curies of radon which was not reported.
On July 16, the company requested an extension to August 15.
The company stated that the pump would be dismantled and that they had contracted with Nuclear Diagnostic Laboratories to dispose of the radium.
The delay was due to waiting for 2 specially constructed Type B 55 gal. drums from a Tennessee firm.
On July 16 state inspectors again visited the site.
The inspector verified the company's plan to dispose of the radium.
The inspector also stated that the company has moved toward correcting the problem of shipping material to unlicensed customers.
One item of noncompliance was cited concerning the exhaust system not working.
The licensee was again admonished to respond to the previous items cited.
On July 21, 1981 the company submitted a report on the +1 curie release of radon including details of corrective action.
Around this time the July 6 order was extended to August 15 as the company requested.
On July 30, state inspectors met with the president of the company, the RSO and others to discuss the delays in responding to the violations cited.
Basically the result of the meeting was a commitment on the part of the licensee to allow the RSO to work full time on safety matters and to get more help for the RSO.
SR-3 Further inspections were performed on August 6, 13, 20, 27, September 3, 11, 15, 24, October 13 and 23.
During these inspections radon samples were taken and wipes collected, discussions about the handling procedures for disposal of the radon.
Letters continued to cite the company's lack of efforts to stay in compliance.
During this time the " Order to Comply" was.being continuously extended.
Apparently the radium solution was finally packaged and disposed of on October 31, 1981.
In a letter dated December 11, 1981, the company RSO attempted to respond to the enforcement letters which had been issued to the company since the July 1980 inspection.
Some of the problem were resolved by the disposal of the radium, but there were other problems which the licenste did not adequately address.
The State sent a letter to the company on January 6,1982 detailing what additional information would be required.
Of particular concern to the State at this time was the dismantling of the equip-ment in the pump room and decontamination of the facility.
Other areas of concern were the repair of the tritium hood, development of procedures for instrument calibration, shipping and receiving procedures, the use of protective clothing, revised record keeping system, and program for checking ventilation.
The company was given until January 15 to respond.
On January 26, 1982 the State sent a letter to the company reminding them that the July 6, 1981 letter was still in effect and requested a response by February 1.
On January 28, the RSO submitted a letter discussing procedures to be followed in dismantlir.g the pumo and decontaminating the room.
The procedure left a lot to be desired and on February 8 the State sent a letter discussing the deficiencies.
Of particular concern to the State was the presence of the company's HP consultant during the work, since the State has long since become skeptical of the. company RS0's abilities to handle radiation safety.
The State also specified that the company must cover all floors and other surfaces with absorbent paper, use protective clothing and respirators, perform a complete radiation survey.
The last correspondence was dated March 17, 1982.
At that time the State was still placing requirements on the company regarding the cleanup of the pump.
As of the time of the review the company still had not performed this cleanup.
It was evident, in the review of this file, that the State's enforcement efforts have been less than ideal.
The continuous issance of " Orders to Comply" and the extension on the compliance dates showed the licensee's 9;
apparent lack of regard for the orders.
Civil penalties, if the State had had l
authority to issue them, might have accelerated the compliance effort.
l l
w
+ -
APPENDIX J REVIEW OF SELECTED COMPLIANCE FILES 1.
Licensee:
UPA Technology Inspector:
Lou Cabasino License No:
741-0921, Reviewed by:
11/30/80 but no signature (Backscatter B-emitter) of supervisor indicated Date of Inspection:
8/12, 13, Enforcement Letter:
none sent, 591 15/80 left with licensee for response Type of Inspection; Routine License Response:
9/15/80 Type of Form used:
Standard (591) No. of N/C cited:
4 Enforcement letter wasn't sent but a copy of Inspection Findings" a.
form was left with the licensee.
b.
Previous items of N/C not discussed / mentioned.
c.
Acknowledgement of receipt by State of N/C response was not done.
d.
Unannounced or announced wasn't specified.
2.
Licenso:
Atlantic Testing Inspector:
L. M. Schuster
(
Laboratories License No:
2125-2253 (Gauge)
Reviewed by:
no supervisor review indicated Date of Inspection:
7/26/79 Enforcement letter:
8/6/79 signed by F. Bradley Type of Inspection:
Routine License response:
none documented Type of Form used:
Standard (591) No. of N/C cited:
8 a.
Inspection is timely!
b.
Announced or unannounced not indicated.
c.
No worker interview documented.
d.
No State acknowledgement of receipt of licensees response to cited noncompliance items.
e.
Previous noncompliance items not in report.
This should be summarized to assure that appropriate followup of previous N/C items has been conducted (as was committed by licensee in letter to State).
3.
Licensee:
Rodale Electronics Inspector:
Lou Cabasino License No:
2218-2985 (Invitro)
Reviewed by:
F. J. Dradley 11/27/79 and initialed Date of Inspection:
10/3/79 Enforcement letter:
10/29/79 signed by L. Cabasino Type of Inspection:
Routine Licensing Response:
11/5/79 Type of Form used:
Standard (591) No. of N/C cited:
3 a.
Previous noncompliance items not mentioned.
J-2 b.
Announced or unannounced not indicated.
c.
State acknowledgement to licensee response.
d.
Rest of report looks clean.
4.
Licensee:
Twin City Inspector:
Bob Kelley International, Inc.
License No:
278-0897 and Reviewed by:
F. J. Bradley 2/3/82 and 1402-0897 (GL) initialed Date of Inspection:
5/27/81 Enforcement letter:
6/5/81 signed by Kelley Type of Inspection:
Routine License Response:
6/19/81 Type of form Used:
Standard (591) No. of N/C cited:
2 a.
Announced or unannounced not indicated however it appears to have been an announced with regard to the tone of the report, b.
Clean report.
5.
Licensee:
Herbert Products Inspector:
L. M. Schuster License No:
1430-1950, (GL)
Reviewed by:
F. J. Bradley 1/19/79 and initialed Date of Inspection:
2/13/78 Enforcement letter:
none sent*
Type of Inspection:
- Routine, License response:
1/10/79 unannounced Type of Form used:
Standard (591) No. of N/C cited:
4
- a.
Enforcement letter not sent.
A copy of 591 was left with the licensee to respond.
This is considered acceptable by the State, however, it was recommended that a formal letter be sent signed by supervisor to assure that cited noncompliance items are properly corrected.
b.
Overdue for inspection.
6.
Licensee:
Self-Powered Lighting Inspector:
Lou Cabasino License No: 1308-1811 Reviewed by:
still open
[
Date of Inspection:
2/23/82 Enforcement letter:
2/23/82 Type of Inspection:
Special License Response:
still open Type of Form used:
Standard (591) No. of N/C cited:
1 1
a.
Last regular inspection:
3/12, 13, 19/79 b.
Special and other inspections:
6/26, 27/79; 7/2/79; 7/11/79; 8/16/79; 8/16/79; 10/18/79; 12/7/79; 2/8/80 l
6/18/80; 6/26/80 c.
Most recent priorities inspection was on 3/9-12/81 in which eight j
noncompliance items were found.
d.
SPL is currently under " order on consent" by the NYDEC.
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J-3 Present report did not mention the previous cited (eight) e.
noncompliance items.
7.
Licensee:
Dunlop Tire and Rubber Co.
Inspector:
Bob Kelley License No:
LRX-0317, (Gauge)
Reviewed by:
F. J. Bradley, 6/16/bl* and signed Date of Inspection:
9/18/80 Enforcement letter:
11/14/80 Type of Inspection:
- Routine, Licensee response:
12/15/80 unannounced Type of Form used:
Standard (591)
No. of N/C cited:
5 a.
Inspection results written on Standard Form 00SH246.9 " Notice of Inspection Fingings."
b.
Reports are kept in a " tickler file": until the inspector closes case and signed by supervisor, c.
Worker interview not documented.
- d.
Supervisor doesn't review report until closed out by inspector.
4 8.
Licensee:
Truton (US) Ltd.
Inspector:
L. Schuster License No:
NRC #44-18008-01 Reviewed by:
F. J. Bradley Date of Inspection:
10/30/80 Enforcement letter:
11/02/80 Type of Inspection:
Routine License Response:
11/17/80 Type of Form used:
Standard (591) No. of N/C cited:
10 Noncompliance items cited during inspection:
Radiographic exposure devices not secured during transport.
a.
b.
No documentation of radiographer's qualifications.
c.
No record of pocket dosimeter reading available.
d.
No records of radiation surveys available.
e.
Exposure device stored in motel room at night.
f.
No leak test records.
g.
No copy of State Code or NRC license available.
h.
No " Notice to Employee" sign posted.
1.
Vehicle not placarded during transport.
j.
No daily maintenance inspection list.
.