ML20129G806
| ML20129G806 | |
| Person / Time | |
|---|---|
| Issue date: | 07/31/1994 |
| From: | Michele Burgess NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML20129G101 | List: |
| References | |
| NUDOCS 9610300216 | |
| Download: ML20129G806 (56) | |
Text
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i 's j REVIEW CROUP -
- , RADICTCTIVE DEVICES i
i Comparison of Selected U.S. Nuclear Regulatory Commission Regulations and Current Agreement l State Regulations Regarding the i
General Licenses in 10 CFR 31.5 I
by Michele L. Burgess July 1994 Courtesy of the Sealed Source Safety Section PN R NR PDR G
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- l Contents 4
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j Summary of Findings ....................................... 1 i
, Discu ssion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Section 1 - Camparison Summary List . . . . . . . . . . . . . . . . . . . . . . . . 4 Section 2 - Comparison Between NRC and SSR . . . . . . . . . . . . . . . . . 5 Section 3 - Comparison Between NRC and States . . . . . . . . . . . . . . . . 7
- Section 4 - Additional State Requirements . . . . . . . . . . . . . . . . . . . . . 8
- Section 5 - State Suggestions for improvement of the GL Program . . . . 9 Appendix A - NRC Regulations Used in the Comparison . . . . . . . . . . . . . . . A-1 i
Appendix B - SSR Regulations Used in the Comparison ................ B-1 i
l Appendix C - Detailed Comparison Sheets . . . . . . . . . . . . . . . . . . . . . . . . C-1 4
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Summary of Findings in March 1994, U. S. Nuclear Regulatory Commission (NRC) regulations, the
' Suggested State Regulations (SSR), and Agreement State (State) regulations were evaluated to determine the uniformity of requirements pertaining to items licensed and distributed under the general license (GL) as described in ,
10 CFR 31.5. A total of 21 (72.4 percent) of the 29 Agreement States l participated in the comparison. l The focus of'the comparison was sections 10 CFR 31.5, 32.51,32.51(a), and )
32.52. The State and SSR regulations were compared to the NRC sections listed j above. The Agreement States provided their state regulations equivalent to those listed and information on fees. inspections, and other tracking procedures. In ,
addition, several respondents included suggestions for improvement of the GL ,
program in general.
The requirements of the SSR were found to be equivalent to those of NRC, except !
for the substitution of the use of radioactive material for byproduct material, and wording differences in reference to applicable sections of State Codes or Agencies.
In addition, the SSR omits reference to the importation of devices. These types of t differences were also found in the State regulations and were not considered i omissions for the purposes of the comparison.
Only the State of Texas had regulations that contained significant differences from the NRC regulations. The major difforence was that the Texas regulations pertaining to certain GL devices, oth Pr than gauges, that are designed and ,
manufactured for the purpose of producing light or an ionized atmosphere were j treated in a third category of the State's equivalent to 10 CFR 31.3. In the NRC l regulations,10 CFR 31.3 allows the licensee to possess, without the requirements l of 10 CFR 31.5, certain static elimination devices and ion generating tubes. l Licenses under 10 CFR 31.3 can be issued only by the NRC. !
I Nevada and New York regulations (9.6 percent) contain the same requirements although they do not follow the NRC format and wording. All other participating State regulations (85.6 percent) maintain the requirements of the NRC regulations, ,
in the same or very similar format and wording.
Of the participating States, twelve had additional requirements imposed on the general li.:ensee. These included, but were not limited to, the use of fees, ;
inspections, and tracking or registration systems. In many cases, the additional ;
requirements were not referenced in the regulations received. The purpose of many of these systems has been to provide both financial and informational support of the GL program. The State of Texas required that licensees maintain assignment records for portable or mobile devices including serial number, location, 1
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- dates assigned to location, kept both at the address in the GLA and at the temporary site. The licensees must also keep a copy of the operating and ,
instruction manual at each temporary site. ;
Several States included suggestions for improvement to the GL program. A major concern expressed was the widespread problem that a large proportion of general licensees do not understand or recognize that they are in possession of radioactive ;
material, and that they may not follow the proper methods for disposing of and transferring the devices. It has been indicated that statements made in >
distributor's sales literature and changing personnel are two of the major l contributors to the problem. Suggested solutions to these problems include j tracking or registration systems, fees, facility inspections, phone or mail '
verifications, a restriction on the limits of certain isotopes and uses, and the elimination of the GL program. Some of these solutions are already practiced to .
varying degrees in a few States, and are in the proposed rule change to 31.5 and ,
32.51. !
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Discussion '.I-i This report presents the findings of the general license comparison 1:
iI (SSR), and current Agreement State (State) censed re and distributed under the general license (GL) as described in 10 CFR 3 These States were:of 21 (72.4 percent) of the 29 Agreement . . A total State l
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Alabama, Arizona, Arkansas, Colorado, Floride, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Nebraska ,
w N Mexico,Utah. New York Dept. of Labor, North Carolina, Rhode island,-!
and ,
match and existence of additional requiremen '
1 indicates that the regulations ata essentially the same ein content; differences in reference to applicable. These sections o i differences Sections 2 and 3are common of this report. to all the States and are explained in greate!
i The codes used in this list are not intended to '
correspond to any NRC regulation compatibility rating system. Section 2 o SSR. Section 3 is a comparison of_NRC and Sta j description of any additional requirements imposed by Appendix .
the States A
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SSR regulations used in the comparison. Appen checklists generated for each State.
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! Section 1 - Comparison Summary List of Participating States ;
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+ l tracking !
j State 31.5 32.51 fees inspections (cooes below) '
AL 1 1 occasional selected licensees c 1 -
AZ 1 1
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j AR 1 NS if also have specific license or
! history of problems l
! CO NS 1 $100/yr/ facility b i l FL 1 1 $20/yr/ device, except 5 yrs, except exit signs b
- exit signs GA 1 1 $100/yr/f acility, b except exit signs IL 1 NS lA 1 1 a KS 1 NS " catch-as-catch-can" b KY 1 NS $75/yr, includes exit at least one time, except exit signs c signs LA 1 1 MS 1 1' $150/yr '4-5 yrs e i NE 1 1 NV 1 1 NM 1 1 NY 1 NS requested in next budget NC 1 NS $75/yr, except exit 3-4 yrs, exit signs if also have c signs specific license ;
RI 1 1 I TN 1 1 !
TX 2 NS $200/ facility-initial d i UT 1 NS $50/ facility-5 yrs non-responders to state registration e process or survey Key:
MS - not sent with information recened from State 1 - content some lose Section 31 2 differences in content toes Secten 3)
Emplonation of the tracking system codes:
a- phone survey about every 5 yrs b- database only 1 c- form sent to those on lists from manufacturer's quarterly distribution reports d- General License Acknowledgement (GLA)- says initial fee only, but also says the GLA empires (time limit
. not provided) e- form sont to those on lists from manufacturer's quarterly destribution reports plus mail survey 4
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,a Section 2 - Comparison Between NRC and SSR The requirements of the SSR were found to be equivalent to those of NRC. The ;
differences aside from minor wording changes are as follows:
The SSR includes the words "to own" when referring to the receipt of the devices.
The SSR omits the use of " initially transferred" and substitutes " distributed" in the NRC phrase " manufactured and initially transferred".
The substitution of the use of radioactive material for byproduct material occurred to some degree in all of the regulations examined. The term radioactive material is used versus byproduct material in order to cover all of the hazards that States can regulate, including naturally occurring and accelerator-produced material (NARM), naturally occurring radioactive material (NORM), and byproduct material.
The SSR references the home state in place of the NRC.
Because of differences in format and numbering of sections in the State codes, references to additional provisions are not the same. Since it would have been beyond the scope of this comparison, the statements tying in additional provisions were checked only for similarity of form. The individual provisions were not checked for equivalence.
The SSR omits reference to the importation of devices.
J NRC and Licensing State are included in references to other licensing bodies, to recipients of transfer reports, and to distribution outside the home state.
The Conference of Radiation Control Program Directors, Inc. (CRCPD) is a conglomeration of State representatives that set standards for State NARM and NORM programs. The term " Licensing State" refers to any State approved by the CRCPD to regulate NARM and NORM the way NRC regulates byproduct material. A state can be a Licensing State without being an Agreement State, although as of January 1993 there are no such cases.
The SSR indicates that records for leak tests, on-off mechanisms, and any other tests required by the 10 CFR 31.5 equivalent regulations should be kept for o.ne, one, and two years, respectively. The NRC regulations indicate that all of the above records should be kept for three years. This difference exists because of an increase in the number of years required to keep these records in the NRC regulations. The change was not required to be made by the States.
The SSR does not include reference in the 10 CFR 31.5(c)(3) equivalent to the tests for leakage and proper operation of the on-off mechanism and indicator as required in 10 CFR 31.5(c)(2). The 10 CFR 31.5(c)(3) equivalent specifies only "other tests". Therefore, the SSR doesn't specifically require that the leak and on-off tests are performed according to the device labels, or by a person specifically licensed to perform the activities. See Subdivision C.22d.iii.(2) and (3) on pages C13 and C14 of 5
t the Suggested State Regulations, Volume I dated January 1991 for exact wording.
The differences listed above were found to be ommon in the State regulations and were determined to be format changes not alte.1g the content of the regulat.'on.
They were not considered differences for the purposes of the State comparison.
See Appendix C for the checklist prepared of the SSR differences. Append lx C does not always include raference to these types of differences.
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h Section 3 - Comparison Between NRC and States 1
The comparison for the States includ9d only those differences in excess of the I points listed for the SSR comparison.
3 Only the State of Texas had regulations that contained a significant difference from
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the NRC regulations. Thc State of Texas regulations equivalent to 10 CFR 31.5 does not address devices designed cnd manufactured for the purpose of producing light or an ionized atmosphere 0.e. exit signs, gas chromatographs). The State of Texas equivalent to 10 CFR 31.3, which is a Division I compatibility item and covers static eliminators and ion generating tubes, has been expanded to include these items as a third category. In the NRC regulations,10 CFR 31.3 allows the
} licenses to possess, without the requirements of 10 CFR 31.5, certain static elimination devices and ion generating tubes. Ucences under 10 CFR 31.3 can be l--
issued only by the NRC. In the Texas regulation, additional requirements containing a subset of 10 CFR ?1.5 are added as a subsection under the third category only. The subsection eddresses the same requirements that the State covers in its 10 CFR 31.5 equivalent ex:ept for the following:
The 5: tate of Texas's 10 CFR 3'.3 equivalent is subject to fewer additional state provisions than the 10 CFR 31.5 equivalent. These include requiring g fees, registration, and additional record-keeping.
There are no restrictions listed on who may receive these items under a general license.
These differences and the inclusion of these items in the 10 CFR 31.3 equivalent regulation results in the following:
These items are omitted from the registration and fee requirement imposed on the items covered under the Texas regulation.
The distribution license for these items must be issued by NRC.
The general license to transfer, receive, acquire, possess, and use these devices are not limited by the phrase "...to commercial and industrial firms and to research, educational, and medical institutions, individuals in the conduct of their business, and state or local government agencies...".
The State of Nevada and the State of New York regulations (9.6 percent) contained l'
the same requirements although they do not follov the NRC wording. A difference noted in the State of New York's regulations is that devices containing certain levels of beta , or gamma-emitting materials other than tritium, or certain levels of
{ alpha-emitting materials are not specified as exempt from leak testing.
All other participating States' regulations (85.6 percent) maintain all of the requirements of the NRC regulations, in an equivalent form.
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l la l Section 4 - Additional State Requirements i
in addition to the minimum requirements as determined by the SSR and NRC J
regulations,13 (61.9 percent) of the 21 States participating had additional systems in place covering inspections, fees, and tracking (discussed below). The State of Texas required that licensees maintain assignment records for portable or mobile 4
i devices including serial rumber, location, dates assigned to location, kept both at the address in the GLA and at the temporary site. The licensees must also keep a copy of the operating and instruction manual at each temporary site.
- A total of eight States have some type of fees system in place. Six States have annual fees per facility ranging from $10 to $15u, one State has a $20 annual fee
! per device, and one State has a $200 initial fee only. One State has requested i fees to be added to the 94-95 budget. The fees were assumed to be facility fees if l no positive confirmation could be found otherwise. In most cases, there are no j fees charged for exit signs.
a i Several of the participating States indicated that they would inspect GL items if
! conducting an inspection for a specific license at the same facility or in the same j general area. Eight States have some type of inspection frequency, other than i event related, on general licensees, with three States indicating that they do not l inspect exit signs. Three of the eight indicate that they attempt to inspect at least j once or have a random selection process for determining facilities to inspect.
- Three States inspect on a regular frequency ranging from 3 to 5 years. One State
- will inspect for GL items only if there is a history of problems. The final State will l inspect those licensees that fail to respond to the State's registration process.
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! Eleven Gtates indicated the use of some type of tracking or registration system. ;
i Four of the 11 indicated use of a database tracking system only. One State uses i only a mail survey approximately every 5 years to update information. Six States .
-l send a form to general licensees from a list generated from the manufacturer's quarterly distribution reports, and require some type of registration. It is probable j that these States also use a database system to store this information. -
t l Of the States employing some type of fee, inspection, or tracking system, five have systems which involve all three.
i Several States reported that the general response to the State's requirements for
! registration was favorable. The States indicated that licensees viewed the process i as an indication that safety issues concerning the GL items were being addressed.
j The uso of a fee system was reported both to encourage licensees to report i transfers and to provide financial support for the GL Program. The implementation j of tracking systems was reported to improve accountability of device transfers
, through the inherent verification of information received by the State in i manufacturer transfer reports. The tracking systems also were reported to increase i the licensee's awareness of the products received, to encourage licensee accountability for the devices, and to provide a source of statisticalinformation.
! The use of computerized tracking systems was reported to simplify record keeping
! and informational studies and to facilitate the implementation of fees.
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i -* j Section 5 - State Suggestions for Improvement of the GL Program l
j The majority of the problems that States and licensees had with the GL system !
, were reported to be the result of errors or omissions in manufacturer reports and !
l licensee misinformation. Many of the respondents felt that licensee abandonment, !
j incorrect disposal, or incorrect transfer of the device were commonly because of !
- devices being forgotten through change of personnel or sale of property, or l because of confusion generated by the end user not receiving copies of !
- regulations. In addition, it was reported that some manufacturer's literature states
i that no further licensing is required, sometimes resulting in the licensee assuming '
- that he has no obligations. t 1 l Suggestions for improvement of the general license program have been offered in l four general categories: restrictions on the items that can be generally licensed, 3 agency contact with the user, traceability, and disposal. i
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! One way to reduce the risks associated with the general license program is to I
- eliminate from the program those devices that represent the highest hazard. The j main concerns expressed in this area were portability and activity levels. It was i recommended that portable devices, in-plant gauges, and devices with sources l l greater than class C for disposal purposes should not be generally licensed. In ,
l addition, restrictions on the upper limits on activity for some of the more hazardous :
- isotopes was suggested. As a more extreme alternative, it was suggested that the )
- entire GL program be eliminated and require that if a device does not meet the '
j requirements to be licensed as an exempt item then it must be specifically licensed. .
j Increased contact with the end user was another method for improving the GL i program. It was suggested that changing the current regulations to require that i j copies of regulations be received by the end user and not only the owner of the l device would increase the awareness of the user and eliminate many of the i problems associated with incorrect handling, transfer, loss, and disposal. In
- addition, many respondents offered that database tracking systems and registration i of devices increased the ability of the regulating agency to communicate with the i- end user, thereby providing a means for additional guidance and information
- exchange. Fees in addition to the tracking systems were reported to encourage j general licensee compliance with correct disposal and reporting procedures and to i_ cover partial costs of GL program. Mail / phone surveys and inspections were j suggested to verify compliance with inventory, testing, and record keeping j requirements.
i j improvements in the accountability or traceability of the items was another j suggested area for improvement. It was recommended that the general licensee be
- required to perform 6 or 12 month inventories, and to send duplicate reports of
- leak and shutter tests to the regulating agency. Additional suggestions included better reporting of receiving and transferring devices, more effective notification j system other than quarterly reports, and having reports sent to regulatory agency
1 Disposal and abandonment of devices were major concerns of many of the j respondents. Areas for improvement included requiring the manufacturer provide
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{ a information concerning disposal options and costs before shipment of the devices or for the manufacturer to provide in some way for the disposal of the device.
Two ways proposed were to authorize or.ly the lease of devices or to require that the cost of the device include a commitment by the manufacturer to accept the devics for disposal.
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Appendix A - NRC Reaulations Used in the Comoarison i
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4 UNITED STATES NUCLEAR REGUL ATOHY COMMISSION RULES and R.EGULATIONS fifLF 10. CHAPfER 1 CODE OF FEDERAL REGULAflONS-ENERGY
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_ _____ . ._y 31.1 31.Sc) :
PART GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL i i 31 i l the purpose of detecting. men.surina.
- anuging or controlling thlekness, den-
% sity, level, interface location. radl 4
j
- ation, leakage, or qualitative or quanti-
. tative chemical composition, or for i
- producing light or an lontzed atmas
[phere.
tbl The general lleense in pararraph I Imp of this section applies only to by.
product material contained in devices j, s hich have been mariufactured or int.
- tially transferred and labeled in ac
- cordance tith the specifications con E tained in a speelfle license issued pur a suant to I 32.51 of this chapter er in I accordance tith the specificat tom contained in a specific fleerve Iseucri by an Agreement State a hicle authnr tres distribution of the devices to per sons generally lleensed by the Arree j ment State.
l (c) Any person . a ho acquires, re .
celves. possesses, uses or transfers b3 - jl product material in a device pursuant i to the general license in paragraph rat of this section:
(1) Shall assure that all labels af-fixed to the device at the time of te ceipt and bearing a statement that te moral of the label is prohibited are maintained thereon and shall comply with all instructions and precautions (
provided by such labets; I
- 42) Shall assure that the device is tested for leakage of raoloactive mate.
rial and proper operation of the on off mechanism and indleator,if any. at no
- longer than six-rnonth intervals or at
- such other intervata as are speelfled in
- the label; however:
l til Devices containing only kr>pton
. need not be tested for leakage of ra-
- dioactive material, and (11) Devlees containing only triflum
~3315 rertain measurlag. gauging or con- i or not more than 100 microcuries of '
trollina dedees.' other beta and/or gamma emitting }
(al A d.meral license is hereby lasued material or i
- to conmerdal and industrial firms and 10 microcuries of alpha emitting matenal l
- research, educatienal and medical in.
and devices held in storage in the orismal
stitutions. Individuals in the conduct I l of their bustr.ess, and Federal. State or shipping container poor to initialinttz!!2 1 j
e local government agencies to acquire, ti'm need not be tested for any purpose. '
" recelbe, possess, use or transfer, in ac. (3) Shall assure that the tests required cordance with the provisions of para- by paragraph (cM2) of this section and graphs (b), (c) and (d) of this section- other testing, installation, servicing and typroduct material contained in de. l vices designed and rnanufactured for removal from installation mvolung the I radioactive materials. its shiciding or i
' Persons possessins byproduct material in containment, are performed devices under the general license in 4 31.5 (i) in accordance with the mstructions before Jan.15.1g73, may continue to poe. provided by the labels.or sens, use or transfer that material in accord.
ance with the requirements of f 31.6 in (iil by a person holding a specific ef fect on Jan. 14,1975 license pursuant to Parts 30 and 32 of 31-1 November 30.1992
FART 31 e GENERAL DOMESTIC LICENSF81 FOR BYPRODUCT MATERIAL ,
this chapter or from an Agreement State (8) Except as provided in paragraph 4, install and service such devicein any to perform su(n activities; (c)(9) of this section, shall transfer or
- non Agreement State and a general
"~
~ dispose of the device containing by. 4 license to install and service such device
- (4) Shall metntam records showmg product material only by transfer to a g in offshore waters, as definedin c%mphance with the requirements of person holding a specific license pursuant g i150.3(f)of this chapter:Provided, nat:
par: graphs (c)(2) and (c)(3) of tlus to Parts 30 and 32 of this chapter or from "
s:ctnn. The records must show the results of tests. The records also must an Agreement State, t re:eive the device (a) (Deleted 39 FR 43531.)
show the dates of performance of. and and withm 30 days after transfer of a ! (b) The device has been manufac-the nimes of persons performmg. device to a specific licensee shall furnish o tured, labeled, installed, and serviced in t:stmg. installmg. serwcmg. and to the Director of Nuclear Matenal Safety 'g removmg from the installation accordance with applicable provisions of and Safeguards U.S. Nuclear Regulatory R r:ducctive material and its shielding or the specific license issued to such person Commission, Washmston, D.C. 20555, a cont:inment.ne bcensee shall retam report containing identification of the
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these records as follows: ""
- "I*",' "*** *"d I WMmmmuhmM d'"i DY (i) Each record of a test for leakage or o r:dioactive matenal required by model number and the name and address n
~ par: graph (c)(2) of this section must be of the person receiving the device. No I retzined for three years after the next report is equired if the device is trans- { regulat' ions of the Agreement State which i required leak test is performed or until ferred to the specific licensee in order to a licensed manufacture of the device bor a th3 se led source is transfetred or obtatn a replacement device; 8 statement that removal of the label is
- disposed of.
- 9) Shall transfer the device to {pr habited.
(ii) Each record of a test of the on-off 3 ano(ther generallicensee only: (d) (Deleted 39 FR 43531.l mech nism and indicator required by a par gr:ph (c)(2) of this section must be ; (i) Where the device remains in use at ret:med for three years after the next ; a particular location. In such case the mquired test of the on-off mechanism " transferor shall give the transferee a copy cnd indicator is performed or until the of this section and any safety documents serled source is transferred or disposed identified in the label of the device and of- withm 30 days of the transfer, report to (iii) Each record that is required by par: graph (c)(3) of this section must be the Director of Nuclear Material Safety r2 tim:d for three years from the date of and Safeguards, U.S. Nuclear Regulatory th1 rec rded event or until the device is Commission, Washington, D.C. 20555, transfirred or disposed of. the manufacturer's name and model
~ number of device transferred, the name (5) Upon the occurrence of a fadure and address of the transferee, and he of or damage to, or any indication of a name and/or position o. an individual possible fail,tre of or damage to, the who may constitute a point of contact shielding of the radioactive material or between the Commission and the trans-the on-off mechanism or indicator, or ferce; or upon the detection of 0.005 microcurie (ii) Where the device is held in storage or more removable radioactive matettal, in the original shipping container at its shall immediately suspend operation of intended location of use prior to initial the device untd at has been repaired by ,,,use by a generallicensee.
thz manufacturer or other person holding -
- a specific license pursuant to Parts 30 and h 32 of this chapter or from an Agreement , Ji>(10) Shall comply with the prodsions of E State to repair such devices, or disposed g fl 20.2201 and 20.2202 of this chapter for 3 of by transfer to a person authorized by a
- reporting radiationincidents, theft orlossd
" spreific license to receive the byproduct f licen3ed matenal, but shall be exempt from material contained in the device ano. 2 het other requirements of Parts 19,20, and 21 within 30 days, furnish to the Director of of this chapter.
the appropnate Nuclear Regulatory Com-mission Inspection and Enforcement Rejonal Office hsteil in Appendix D of [ (d) The general bcense in paragrapir Part 20 of this chapter, a report contain
- j (a) of this section does not authonzs the ing a brief description of the event and E manufacture or import of devices the remIdial action taken; (containing byproduct material.
(6) Shall not abandon the device
,containing byproduct matenal; { 31.6 General license to install devices r- % generally licensen in % 31.5.
g (7) Shall not export the device 3 Any person who holds a specific
. containing byproduct material except in ; licenseIssued by an Agreement State
$ accordance with Part i10 of this lll suthorizing the holder to manufacture,
- chapter. Insts!!, or service a device described la L l 31.5 within such Agrpement State is l hereby granted a generallicense to
. 32.29(bl
, FART 32 e SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER ..
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l 3 Subpert S-Generally Licensed items 8 32.51 Byproduct snaterial contained in devices for use under 8 31.5; require.
a ments for license te manuf.ncture, or j
[ j initially transfer. '
8 (a) An application for a specific 11-Icense to manufacture, or initially
- transfer devices containing byprouuct
' material to persons generally licensed under 5 31.5 of this chapter or equiva- j lent regulations of an Agreement !
, State will be approved if: )
(1) The applicant satisfies the gener- I
{al requirements of I 30.33 of this chap- l' ter; (2) The applicant submits sufficient 4
- ,; information relating to the design.
- manufacture, prototype testing. Qual- l
= ity control. labels, proposed uses in. I l stallation. servicing, lest testing, oper-
, . sting and safety instructions, and po-
" tential hazards of the device to pro-vide reasonable assurance that: 4 (1)The device can be safe y operated ,
, by persons not having training in radi- .
_ological protection:
>(11) Under ordinary conditions of
, handling, storage, and use of the device, s the byproduct material contained in the Ei devim will not be released or i i
E inadvertently removed from the device.
3 and it is unlikely that any person will receive in 1 year a dose in excess of to l percent of the annuallimits specified in
$ 20.1201(a) of this chapter: and
- (111) Under accident conditions (such as fire and explosion) associated with handling. storage and use of the device. It is unlittely that any person would receive an external radiation dose or dose commitment in excess of
, the dose to the appropriate organ as k' specified l 32 24. in Column IV of the table in E (3) Each device bears a durable, leg-
- lble, clearly visible label or labels ap-R proved by the Commission which con-tain in a clearly identified and sepa-rate statement:
(!) Instructions and precautions nec.
essary to nasure safe installation, oper-ation. and servicing of the device (doc-uments such as operating and service manuals may be identified in the label and used to provide this information);
.. n... . on .ono
L 32.S ha) 32.52m PART 32 e SPECIFIC DOMESTIC UCENSES TO MANUFACTURE OR TRANSFER ... .
(11) The requirement.s. or lack of re- (1) Primary containment (source Q 32.51a Same: conditions of licenses, quirement, for leak testing, or for test- capsule ); Each person licensed under 32.51 g ing any on off mechanism and indica- (2) Protec tion of primary shalt:
14 tor, including the maximum time in- containment; (a) Furnish a copy of the general
- terval for auch testing, and the identi-E fication of rad'osctive material by iso- (3) Method of sealing containment; license contained in 31.5 of this
$ tope, quantity of radioactivity, and (4) Containment construction ma- chapter to each person to whom he date of determination of the quantity; tenals. directly or through an intermediate and g ($) Form of contained radioactive person transfers byproduct material in a
- h material; device for use pursuant to the general e (6) Maximum temperature withstood Ucense contained in {31.5 of this
$ during prototype tests; chapter.
N> ttill The information called for in (7) M aximum pressure withstood (b) Furnish a copy of the general the following statement in the same or during prototype tests; license contained in the Agreement substantially similar form: ' (8) Maximum quanuty of contained @ State's regulation equivalent to { 31.5 of The receipt. possession, use. and transfer radioactive matenal;
- this chapter, or alternatively, furnish a of this device Mode!
- Serial No. (9) Radiotoxicity of contained radio ' copy of the general license contained in
- are subject to a general lleense or
. active matena;. and @ 31.5 of this chapter, to each person to (10) Operatmg expenence with identi- whom he directly or through an inter-bU Nft or of a state wfth w hh N eal devices or samtilrly designed and m e d iate person transfers byproduct m has entered into an agreement for the exer.
I clse e f regulatory authortty. This label shall constructed devices material in a device for use pursuant to e be maintained on the devlee in a legible con- - the Eenerallicense of an Agreement State.
dition. Removal of this label is prohibited.
If a copy of the general license in { 31.5 carmon-nantoacrm inami" of this chapter is furnished to such mame of manufacturer or initial transfer- person, it shall be accompanied by a note
" - e x plamar.g that use of the device is (c)in the event the applicant desires regulated by the Agreement State under that the general licensee under 5 31.5 of requirements substantially the same as this chapter, or under equivalent those in 31.5 of this chapter.
~
regulations of an Agreement State,be 32.52 Same: material transfer reports (b) In the event the applicant destres authorized to instell the device. collect that the device be required to be tested at the sample to be analyzed by a specific and records.
~
intervals longer than six months, either licensee for leakage of radioactive material, service the device. test the on-for proper operation of the on off muhanism and mdicator. if any, or for off mechanism and indicator, or .emove {
e Each person hcensed under i 32.51 to ice m sta su n, the $ imtially transfer devices to generally leakage of radioactive material or for applicant shallinclude in the e
' bcensed persons g.
both, he shall include in his application M spplication written instructions to be sufficient information to demonstrate R followed by the generallicensee. O that such longer interval is justified by y estimated calendar quarter doses L E performance charactenstics of the device g associated with such activity or _
h or similar devices, and by design features e activities, and the bases for these (a) Report to the Director of Nuclear estimates. The submitted information K
w which have a significiant beanns on the must demcastrate that performance of Material Safety and Safeguards, U.S.
g probabdity or consequences ofleakage of this activity or activities by an Nuclear Regulatory Co m mis sion, radioactive matenal from the device or individual untrained in radiological Washington, D.C. 20555, with a copy to failure of the on off mechanism and prote.: tion, in additton to other the appropriate NRC Regional Office indicator. In determining the acceptable nandl10g. storage and use of devices listed in Appendix D of Part 20 of this mtIrval for the test for leakage of under the genect! license, is unlikely to cause that individual to receive a dose chapter, all transfers of such devices to radioactive matenal, the Commission will persons for use under the general heense in excesa of to percent of the annual consider mformation which includes, but 0 in i 31.5 of this chapter. Such report limits specified in $ 20.1201(al of this is not limited to: chapter. E shall identify each general licensee by e name and address, an individual by name
~
h and/or position who may constitute a point of contact between the Commission and the general licensee, the type and model number of device transferred, and the quantity and type of byproduct material contained in the device. If one or more intermediate persons will tempo-rardy possess the device at the intended
'Devtus licensed under i 32.51 prior to place of use prior to its possession by the January ts.19'IS may bear labels authortzed ty the regulations in effect on January 1. user, the report shall include identifica-e model. sertal number, and the name (f the manufacturer, or initial transferor name, addresa, contact, and relationship may be omitted from this label provided the information is elsewhere spectiled in label.
ing affixed to the device.
32.52(a) 32.54(a s
'. PART 32 e SPECIFIC DOMESTIC UCENSES TO MANUFACTURE OR TRANSFER ...
to the intended user, if no transfers have pliance with the report requirements of been made to persons generally licensed this section.
under i 31.5 of this chapter during the J-p reporting period, the report shall sok The records required by this r*+
- indicate. The report shall cover eachSgraph shall be matntained for a period I
," ca!:ndar quarter and shall be filed withinf of five years from the date of the t 30 days thereafter. The first report to be; recorded event. )
~
- filed pursuant to this paragraph as revised a ,
and effective on January 15,1975, sha cover the first calendar quarter in 1975.
The report,if any, required for the fourth calendar quarter in 1974 shall be filed pursuant to the requirements of this aragraph in effect on January 14,1975.
(b) Report to the responsible Agree-ment State agencv all transfers of such devices to persons for use under a j general license in an Agreement State's l regulation equivalent to 5 31.5 of this chapter. Such report shall identify each general licensee by ,name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general licensee, the type and model number of device transferred, and the quantity and type of by pr oduct matenal contained in the device. if one or more intermediate persons will temporanly l
- possess the device at the intended place l lof use prior to its possession by the ,
e vaer, the report shall include identifica- a; A tion of each intermediate person by a
~
Q g name, addresa, contact, and relationship to the intended user. The report shall ]
be submitted within 30 days after the end of each calendar quarter in which i such a device is transferred to the generally licensed person. If no trans-fers have been made to a particular Agreement State dunrg the reporting period, this information shall be reported to the responsible Agreement State agency upon request of the agency. The first report, if any, to be filed pursuant to this paragraph as revised and effective on January 15, 1975, shall cover the first calendar quarter in 1975.
(c) Keep records showtng the name, address, and a point of contact for each general licensee to whom he directly or throueb an intermediate person transfers byproduct matenal in devices for use pursuant to the general license provided tn 6 31.5 of this chapter or equivalent regulations of an Agreement State. The records shall show the date of each transfer, the isotope and quantity of radioactivity in each device transferred, the identity of any intermediate person, and com-O
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1 l Anoendix B - SSR Reaulations Used in the Comparison 1
! The following is taken from the Suggested State Regulations for the Control of Radiation, Volume I, dated January 1991.
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h SSRQt Volume ! January 1991 Sec. C.22 General Licenses * - Radioactive Material Other Than Source Material
- a. Certain Devices and Eauioment. A general license is hereby issued to transfer, receive, acquire, own, possess, and use radioactive material incorporated in the following devices or equipment which have been manufactured, tested and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the NRC for use pursuant to Section 31.3 of 10 CFR Part 31. This general license is subject to the provisions of Sections A.4 through A.9, Subparagraph C.4a.ii., Sections C.31, C.40, C.50 and Parts D4/, J, and T of these regulations.
- i. Srmric Flimination Device. Devices designed for use as static elinunators which contain, as a scaled source or sources, radioactive material consisting of a total of not more than 500 microcuries (18.5 MBq) of polonium-210 per device.
ii. Ion Generating Tube. Devices designed for ionization of air which contain, as a scaled source or sources, radioactive material consisting of a total of not more than 500 microcuries (18.5 MBq) of polonium-210 per device or a total of not more than 50 millicuries (1.85 GBq) of hydmgen-3 (tritium) per device.
- b. Reserved
- c. Reserved
- d. Certidn Measunne Gauring or Controlling Devices
- i. A general license is hereby issued to commercial and industrial firms and to research, educational and medical institutions, individuals in the conduct of their business, and State or local government agencies to own, receive, acquire, possess, use or transfer in accordance with the provisions of Subp r.p.phs C.22d.ii., iii., and iv., radioactive material, excluding special nuclear material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.
' Note: DQtrent general licenses are usued ivi this secnon, sadt of which has its own speqfic condstunu and requirements.
y Attention is derected partacularly to the provuions of Part D of these regulanons which relate to the labelirg of contasners.
_ __ ._ . _ _ _ _.____ _ . _ _ _ . _ .. .- ___m SSRCR Volume ! January 1991 )
ii. The general license in Subparagraph C.22d.i. applies only to radioactive material contained in deuces which have been manufactured and labeled in accordance with the specifications contained in a specific license issued by the Agency punuant to Paragraph C.28d. or in accordance with the specifications l i
contained in a specific license issued by the NRC, an Agreement State or a-Licensing State, which authorize > distribution of devices to penons generally licensed by the NRC, an Agreement State or a Licensing State.5/ l iii. Any person who owns, receives, acquires, possesses, uses, or transfen ,
radioactive material in a device pursuant to the general license in Subparagraph .
C.22d.i.:
(1) shall assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, are mamtained thereon and shall comply with allinstructions and precautions provided by such labels; l (2) shall assure mat the device is tested for leakage of radioactive material ,
and proper operation of the "on-off" mechanism and indicator, if any, at l no longer than 6 month intervals or at such other intervals as are specified in the label, however, ;
i (a) devices contammg only krypton need not be tested for leakage of !
radioactive material, and (b) devices contaming only tritium or not more than 100 microcuries (3.7 MBq) of other beta- and/or gamma-emitting material or 10 microcuries (0.37 MBq) of alpha-emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose; (3) shall assure that other testing, installation, servicing, and removal from installation involving the radioactive material, its shielding or containment, are perfotmed:
(a) in accordance with the instructions provided by the labels, or (b) by a person holding an applicable specific license from the Agency, the NRC, an Agreement State or a Licensing State to perform such activities; y Regulanons under the Federal Food, Drug, and Cosmene Act authernang the une of redscaenn control devnces an food producnon requsre certann addanonal labelsng thereon whsch is found in 21 Cnt 179.21.
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- SSRQt Volume ! January 1991
- l l (4) shall mamtain records showing compliance with the requirements of i Subdivision C.22d.iii.(2) and (3). The records shall show the results of
- tests. The records also shall show the dates of performance of, and the names of persons perfornung, testing, installation, servicing, and removal i
- from installation conceming the radioactive material, its shielding or i contamment. Records of tests for leakage of radioactive material
- required by Subdivision C.22d.iii.(2) shall be mamtained for 1 year after j the next required leak test is perfor ned or until the sealed source is
- transferred or disposed of. Recor6 of tests of the "on-off" mechanism l and indicator required by Subdivision C.22d.iii.(2) shall be mamtained
! for 1 year after the next required test of the "on-off" mechanism and ;
! indicator is performed or until the scaled source is transferred or disposed of. Records which are required by Subdivision C.22d.iii.(3) l shall be mamtained for a period of 2 years ' rom the date of the recorded I i event or undl the device is transferred or disposed of; f
(5) upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive materia
- or the "on-off" mechanism or indicator, or upon the detection of 0.005 j microcurie (185 Bq) or more removable radioactive material, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding an applicable specific ,
i license from the Agency, the NRC, an Agreement State or a Licensing i State to repair such devices, or disposed of by transfer to a person j authorized by an applicable specific license to receive the radioactive
> material contained in the device and, within 30 days, furmsh to the
- i. Agency a report containmg a brief description of the event and the
- remedial action taken; 4
l (6) shall not abandon the device containing radioactive material; l (7) except as provided in Subdivision C.22d.iii.(8), shall transfer or dispose i
of the device containing radioactive material only by transfer to a specific j licensee of the Agency, the NRC, an Agreement State or a Licensing State f whose specific license authorizes him to receive the desice and within 30 4 days after transfer of a device to a specific licensee shall furnish to the Agency a report containmg identificatiu of the device by manufacturer's name and model number and the name and address of the person i
i receiving the device. No report is required if the device is transferred to i the specific licensee in order to obtain a replacement device;
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SSRCR Volume ! January 1991
(
(8) shall transfer the device to another general licensee only: ,
i (a) where the device remains in use at a particular location. In such i case the transferor shall give the transferee a copy of this regulation and any safety _ documents identified in the label on the ,
device and within 30 days of the transfer, report to the Agency the manufacturer's name and model numb . of device transferred, the name and address of the transferee, and the name and/or position of an individual who may constitute a point of contact between j' the Agency and the transferee; or i
I (b) where the device is held in storage in the origmal shipping
- container at its intended location of use prior to initial use by a general licensee; and (9) shall comply with the provisions of Sections D.402 and D.403 of these l
regul-tions for reporting radiation incidents, theft, or loss of licensed matenal, but shall be exempt from the other requirements of Parts 0 and J of these regulations.
iv. The general license in Subparagraph C.22d.i. does not authorize the -
manufacture of devices contaming radioactive material. ,
- v. The general license provided in Subparagraph C.22d.i. is subject to the ,
provisions of Sections A.4 through A.9, C.31, C.40, C.50, and Part T of these l regulations. l l
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SSRot Volume ! January 1991 Sec. C.28 Special Reauirements for a Specific License to Manufacture Assemble. Repair.
or Distribute Commodities. Products. or Devices which Contain Radioactive MatenM
- d. Ihamine the unmdeure and Distribudon of Devices to Penons Generally Ucensed Under Fe- .sh C.22d.
- i. An application for a specific license to manufacture or distdbute devices containing radioactive material, excluding special nuclear matedal, to persons generally licensed under Paragraph C.22d. or equivalent regulations of the NRC, an Agreement State, or a Licensing State will be approved if:
(1) the applicant satisfies the general requirements of Section C.25; (2) the applicant submits sufficient information relating to the design, i' manufacture, ,.ototype testing, qu..aty control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:
(a) the device can be safely operated by persons not having trauung in radiological protection, (b) under ordmary conditions of hmadling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvenently removed from the device, and it is unhkely that any person will receive in any period of I calendar quaner a dose in excess of 10 percent of the limits specified in the table in Paragraph D.101a. of tnese regulations, and (c) under accident conditions such as fire and explosion associated i
with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses:
Whole body; head and trunk; active blood forming organs; gonads; or lens of eye . . . . . . . . . . . 15 rems (150 mSv)
Hands and forearms; feet and ankles; locahzed ,
areas of skin averaged over areas no larger than I square centimeter . . . . . . . . . . . . . . . . . . . . 200 rems (2 Sv)
Other organs . . . . . . . . . . . . . . . . . . . . . . . 50 rems (500 mSv);
and
SSRQt Volume ! January 1991 (3) cach device bears a durable, legible, clearly visible label or labels approved by the Agency, which contain in a clearly identified and separate statement:
(a) instructions and precautions necessary to assure safe installation, operation, and servicing'of the device; documents such as operating and service manuals may be identified in the label and used to provide this information, (b) the requirement, or lack of requirement, for leak testing, or for testing any "on.off" mecharusm and indicator, including the '
mammum time interval for such testing, and the identification of radioacuve material by isotope, quantity of radioactivity, and date of deternunation of the quantity, and i
(c) the information called for in one of the followmg statements, as appropriate, in the same or substantially similar form:
(i) The receipt, possession, use, and transfer of this device, Model Serial No. 2/, are subject to a ,
general license or the equivalent and the regulations of the NRC or a State with which the NRC has entered into an agreement for the exercise of regulatory authority. This label shall be mamtained on the device in a legible condition. Removal of this label is prohibited.
CAUTION - RADIOACrlVE MATERIAL Name of manufacturer or distributor (2) The receipt, possession, use, and transfer of this device, Model Serial No. 2/, are subject to a general license or the equivalent, and the regulations of a Licensing State. This label shall be mamtained on the device in a legible condition. Removal of this label is prohibited.
CAUTION - RADIOACTIVE MATERIAL Name of manufacturer or distributor y/ Ine monet, ser\ial number, and name of the mans 4aaurer or dastnbutor may be omittedJVom thk label provided j the uqormation is elsewhere spaq6ed m labelang afbred to the devnce
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{ SSitOt Volume ! January 1991 i
f li. In the event the applicant desires that the device be required to be tested at intervals longer than 6 months, either for proper operation of the "on-off" ;
- mechamsm and indicator, if any, or for leakage of radioactive material or for i both, the applicant shall include in the application sufficient information to
- demonstrate that such longer interval 1.; justified by performance characteristics
! of the device or similar devices and by design features which have a significant i bearmg on the probability or consequences ofleakage of radioactive material :
i from the device or failure of the "on-off mechamsm and indicator. In i determining the acceptable interval for the test for leakage of radioactive ;
i material, the Agency will consider information which includes, but is not limited to:
l (1) pnmary containment or source capsule; (2) protection of pnmary contamment; (3) method of sealing contamment; (4) contamment construction materials; (S) form of contained radioactive material; (6) mammum temperature withstood dunng prototype tests; (7) mammum pressure withstood dunng prototype tests; (8) maximum quantity of contained radioactive material; (9) radiotoxicity of contained radioactive material; and (10) operating experience with identical devices or similarly designed and constructed devices.
iii. In the event the applicant desires that the general licensee under Parap 1ph C.22d., or under equivalent regulations of the NRC, an Agreement State, or a Licensing State be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of adioactive material, service the device, test the "on-off mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and basis for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a calendar quarter dose in excess of 10 percent of the ]
limits specified in the table in Paragraph D.101a. of these regulations.
k j i SSRQt Volume ! January 1991 :
iv. - Each person licensed under Paragraph C.0Gd. to distribute devices to generally !
i licensed persons shall:
t ;
(1) furnish a copy of the general license contained in Paragraph C.22d. to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general l
- license contained in Paragraph C.22d.;
(2) furnish a copy of the general license contained in the NRC's, Agreement State's,_or Licensing State's regulation equivalent to Paragraph C.22d., or ,
l alternatively, fumish a copy of the general license contained in
! Paragraph C.22d. to each person to whom he directly or through an I
- intermediate person transfers radioactive material in a device for use .
' pursuant to the general license of the NRC, the Agreement State, or the j Ucensing State. If a copy cf the general license in Paragraph C.22d. is j furnished to such a person, it shall be accompanied by a note explammg 1 that the use of the device is regulated by the NRC, Agreement State, or l l
- Ilcensing State under requirements substantially the same as those in
! Paragraph C.22d.;
f (3) report to the Agency all transfers of such devices to persons for use under the general license in Paragraph C.22d. Such report shall identify each general licensee by name and addres , an individual by name and/or position who may constitute a point of contact between the -
Agency and the general licensee, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If one or more intennediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user.
If no transfers have been made to persons generally licensed under Paragraph C.22d. during the reporting period, the repon shall so indicate. The report shall cover each calendar quaner and shall be filed within 30 days thereafter; (4) furnish reports to other agencies.
(a) Report to the NRC all transfers of such devices to persons for use under the NRC general license in Section 31.5 of 10 CFR Part 31.
(b) Report to the responsible State agency all transfers of devices manufactured and distributed pursuant to Paragraph C.28d. for use under a general license in that State's regulations equivalent to Paragraph C.22d.
ssnat vauma na,,,, ;yy; !
(c) Such reports shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the agency and the general .
licensee, the type and model of the device transferred, and the quantny and type of radioactive material contained in the device.
If one or more intermediate penons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intennediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the generally licensed person.
(d) If no transfers have been made to NRC licensees during the reporting period, this information shall be reported to the NRC.
(e) If no transfers have been made to general licensees within a particular State dunng tie reporting period, this information shall be reported to the responsible State agency upon request of that agency; and keep records showmg the name, addrese and the point of contact for j (5) cach general licensee to whom he direct / or through an intermediate person transfers radioactive material in devices for use pursuant to the l general license provided in Paragraph C.22d., or equivalent regulations of the NRC, an Agreement State, or a Licensing State. The records shall show the date of each transfer, the radionuclide and the quantity of !
radioactivity in each device transferred, the identity of any intermediate person, and compliance with the report requirements of Subparagraph l C.28d.iv.
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- Anoendix C - Detailed Comcarison Sheets 3
Following are the comparison sheets generated during the research phase of the
- j. comparison. They indicate differences found between the NRC regulations and i those of the State. Because of differences in State regulation format and numbering, the section numbers on the sheets correspond to the NRC regulations.
I The first sheet details the comparison of NRC regulations and the SSR. The j remainder of the sheets are the State comparisons and are listed in alphabetical
- order. j I
)
I C-1
\ . _ _
. =. . - - _. .. ._. . - . . ._. - .- -_ .
, GL comparison with sugg state regs '
30.31 C.20 same
, C.20.a similar, wording different (missing from "although the filing of" to the end of the paragraph
! C.20.b similar, wording different i 1
RH-401. added i 31,3 C.22.a sub: device or equipment "which is listed in Part I.... ** SSR also: tested and labeled *
- sub: provisions different, not checked if OK 31.3 (a_1 C.22.a.i
. not listed 31.3 (bj C.22.a.ii not listed 31.5 C.22.d 31.5 (d C.22.d.i exact (ref change OK) 31.5 lb) C.22.d.ii (ref change OK) *
- SSR also: issued by " licensing state" '
31.5 (c) C.22.d.iii ref change OK 31.5 (c) (1) C.22.d.iii.(1) exact 31.5 (c) (2) C.22.d.iii.(2) exact 31.5 (c) (2) (i) C.22.d.iii.(2).(a) exact 31.5 (c) (2) (ii) C.22.d.iii.(2).(b) exact 31.5 (c) (3) C.22.d.iii.(3) exact (ref OK) 31.5 (c) (3) (i) C.22.d.iii.(3).(a) exact 31.5 (c) (3) (ii) C.22.d.iii.(3).(b) SSR also: an " applicable" specific *
- SSR also: " licensing state" 31.5 (c) (4) C.22.d.iii.(4) sub: " installation servicing" (SSR has
" installation, servicing") *
- no mention of how long to keep records 31.5 (c) (5) C.22.d.iii.(5) SSR also: an " applicable" specific *
- SSR also: " licensing state" 31.5 (c) (6) C.22.d.iii.(6) exact 31.5 (c) (8) C.22.d.iii.(7) SSR also: " licensing state" C-2 l
31.5 (c) (9) C.22.d.iii.(8) exact ;
31.5 (c) (9) (i) C.22.d.iii.(8).(a) exact j
' 31.5 (c) (9) (ii) C.22.d.iii.(8),(b) exact l 31.5 (c) (10) C.22.d.iii.(9) ref change - did not check 31.5 (d) C.22.d.iv exact added C.22.d.v ref change - did not check f
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i GL Comparison with NRC Regulations l State: Alabama
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State Agency: Alabama Dept. of Public Health Address: 434 Monroe Street 4
Montgomery, AL 36130-3017
Contact:
David Walter, Radiation Physicist ll 4
Radioactive Material Licensing Branch Division of Radiation Contro:
4 Bureau of Health Care Standards 1
31.5 (b) NRC also " initially transfer" *
- added: FDA provisions i
31.5 (c) (4) sub: 1/1/2 years i
31.5 (c) (7) not found 31.5 (d) NRC also: "or import" added: additional state provisions
?2.51 (a) (3) (iii) provides a second format choice for the label 32.52 (c) does not require: " keep records 5 years" !
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__._m . .__ _._ . _ _ _ . _ _ . _ _ _ ._ .
GL Comparison with NRC Regulations i State: Arizona State Agency: Arizona Radiation Regulatory Agency Address: 4814 South 40th Street Phoenix, AZ 85040
Contact:
Aubrey V. Godwin, Director 602-255-4845 FAX 602-437-0705 <
31.5 (b) NRC also: "or initially transfer" *
- added: FD&C provisions 31.5 (c) added: "own" 31.5 (c) (4) sub: "shall" for "must *
- sub: "1/1/2 yrs" l
31.5 (c) (7) not found 31.5 (d) NRC also: "or import" added: additional state provisions 32.51 (a) (3) (iii) provides second format choice for !abel 32.52 (c) NRC also requires: " keep reports for 5 years" l
C-5
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GL Comparison with NRC Regulations State: Arkansas I State Agency: Arkansas Department of Health 1 i 1
Address: 4815 West Markham St i Little Ttock, Arkansas 72205-3867 '
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Contact:
Steve E. Mack Health Physicist '
Division of Radiation Control and Emergency Management (501) 661-2301 1 1
inspections: only if on site for a specific license inspection, or if licensee has shown a history of poor compliance .
I additional tracking / reports: none other: "32.52 (c) contains the requirement that transfer records be maintained for five years. The A regs do not specify a time limit.
Since there are no manufacturers nor distributors in the State to which these regs apply, no Dept admin policy has been developed to include this time period."
l adds RH-401. General Licenses - Source Material. '
i 31.3 *
- NRC also: manufactured, " tested and labeled" pursuant l 31.3 (a) not listed out j 31.3 (b) not listed out l 31.5 not found l 31.5 (a) *
- NRC also: and " Federal," state *
- added: to "own," receive *
- i sub: provisions of "RH-402.b.2,3,4 radioactive" material *
- added: material,
" excluding special nuclear material," contained 31.5 (b) *
- sub: applies only to " radioactive" material (NRC uses byproduct material) *
- NRC also manufactured "or initially transferred" and labeled 31.5 (c.) added: who "cwns", acquires *
- sub: transfers " radioactive" material (NRC uses byproduct material) 31.5 (c) (3) (ii) exact except for "from the Department, the U.S. NRC or an Agreement State to perform such activities" C-6
31.5 (c) (4) sub: records "shall" show (NRC uses must) *
- sub: records also .
"shall" show (NRC uses must) *
- wording in last 3 lines (not sure if it says the same legally) 31.5 (c) (4) (i) not found, no time limits specified for how long to keep records 31.5 (c) (4) (i) not found 31.5 (c) (4) (i) not found 31.5 (c) (5) exact except sub: receive the " radioactive" material (NRC uses byproduct material) 31.5 (c) (6) exact except sub: containing the " radioactive" material (NRC uses byproduct material) 31.5 (c) (7) not found, letter from them says "31.5 (c) (7) prohibits the export of devices generally licensed. The Arkansas regulations do not contain this specific prohibition. No general licensee has ever expressed an interest in exporting such devices, nor is the problem anticipated to arise."
31.5 (d) exact except NRC also: manufacture "or import" of *
- sub: containing
" radioactive" material (NRC uses byproduct material) adds RH-402.b.5 referring to state provisions i
l 32.51 not found in packet i
C-7
i GL Comparison with NRC Regulations
- State
- Colorado State Agency: State Dept. of Health
- Radiation Control Division Address
- 4300 Cherry Creek Drive South
, Denver, CO 80222-1530
Contact:
Charles E. Mattson Environmental Protection l Specialist 3 i
fees: $100/yr/ facility inspections: for exposure or material release only i
j additional tracking / reports: database
)
31.5 not sent 32.51 (a) (3) (iii) provides a second format choice for the labels 32.52 (c) NRC also requires: " keep records 5 years" C-8
. . _ - . ~ _ .
i GL Comparison with NRC Regulations
]
l State: Florida State Agency: State of Florida
! Dept. of Health and Rehabilitative Services Office of Radiation Control Radioactive Materials Section -
i I i Address: 1317 Winewood Blvd.
Tallahassee, FL 32399-0700 .,
Contact:
Michael N. Stephens Public Health Physicist 1 5
fees: fees for five general licenses-4
- GL static eliminators and measuring, gauging and controlling devices '
4
- $20 per device per year '
- DU, in-vivo, and in-vitro GL is $100 per device per year !
- billed on the first workday in May, due July 1 '
i
- number of devices is taken from the manufacturer's quarterly notification lists. number reduced if licensee provides documentation ,
that the device was properly disposed of i i
inspections: static elim, devices, in-vivo and in-vitro certificate holders on a 5 year l frequency
{ 31.3' sub: use " radioactive" material (NRC uses byproduct) *
- limits to i manufacturer specifically lic under 31.3 of NRC *
- also: subject to provisions of
, some state regs 31.3 (a) exact except sub: use " radioactive" material (NRC uses byproduct)'
[ 31.3 (b) exact except sub: use " radioactive" material (NRC uses byproduct) i 31.5 (a) exact except also: to "own," receive *
- sub: use " radioactive
! material, excluding special nuclear material" (NRC uses byproduct material) i 31.5 (b) - sub: use " radioactive" material (NRC uses byproduct) *
- NRC also ;
i manufactured "or initially transferred" and labeled *
- added: regarding Federal Food, Drug and Cosmetic Act and 21 CFR Part 179 i
31.5 (c) also: who " owns," receives *
- sub: transfers " radioactive" material (NRC uses byproduct)
, 31.5 (c) (4) some sub of shall for must i
31.5 (c) (4) (i) 1 year to keep leak test records (NRC is 3) :
- 31.5 (c) (4) (i) 1 year to keep on-off test records (NRC is 3)
C-9
. . .- - - - - - = . - . - . - . . - . - . - - . -- -.
t
! l 4
. )
31.5 (c) (4) (i) 2 year to keep other test records (NRC is 3) 31.5 (c) (5) sub: receive the " radioactive" material (NRC uses byproduct)
. 31.5 (c) (6) sub: containing the " radioactive" material (NRC uses byproduct) l l 31.5 (c) (7) not found 31.5 (c) (8) sub: containing " radioactive" material (NRC uses byproduct)
. 31.'.i (c) (10) refers to state regs and parts (not available so do not know if they i ara compatible provisions) j 31.5 (d) NRC also: manufacture "or import" of devices
- adds 10D 91.306 (4) (e) referring to state provisions 4
32.51 (a) sub: " distribute" for initially transfer *
- sub: " radioactive material, excluding special nuclear material" for byproduct material *
- wording different sub:
" possessing a GL" 32.51 (a) ;2) (ii) sub: " radioactive" for byproduct *
- NRC also some info on other type of user 32.51 (a) (3) (iii) provides two choices for labels j 32.51 (b) exact except NRC add: "but not limited to"
, 32.51 (c) also Licensing State i
i 4
i d
C-10
i GL Comparison with NRC Regulations State: Georgia State Agency: Georgia Dept. of Natural Resources >
Environmental Protection Division Address: 205 Butler Street, S.E.
East Floyd Tower .
Atlanta, GA 30334 :
Contact:
Cornelius Maryland, Prin.
Radiological Health Specialist (404) 362-2675 or Ralph McCoy at same address and number ,
i fees: $100/yr/ facility, no exit signs inspections: for cause only
- additional tracking / reports: database i
~
31.5 (a) added: "own" *
- sub: " radioactive" 31.5 (b) NRC also " initially transfer" *
- added: FDA provisions l 31.5 (c) (4) sub: 1/1/2 years 31 5 (c) (7) not found 31.5 (d) NRC also: "or import" added: additional state provisions 32.51 (a) (3) (iii) provides second format choica for labals ;
l 32.52 (c) NRC also requires: " keep records 5 years" I
\
J l
l l
l l
i C-11
GL Comparison with NRC Regulations
.1 State: lilinois State Agency: State of lilinois Department of Nuclear Safety
., Address: 1035 Outer Park Dr i Springfield, 111 6 2 7 0 4
Contact:
Bruce J. Sanza, Head Inspection and Enforcement Division of Radioactive Materials (217) 785-9947 31.5 (a) *
- NRC also: and " Federal," state *
- added: to "own," receive *
- sub: transfers " radioactive" material (NRC uses byproduct material) *
- added:
j material, " excluding special nuclear material," contained 31.5 (b) IL code Section 330.280 (d) same as 32.51? *
- added: A State, "or a Licensing State," which added: agency note regard?ng Fed. Food, Drug and Cosmetic Act 31.5 (c) added: who " owns," receives *
- subi transfers " radioactive" material-(NRC uses byproduct)
' 31.5 (c) (4 sub: "shall" (NRC uses must) *
- 1 year to keep leak test records (NRC is 3) 'I year to keep on-off test records (NRC is 3) *
- 2 year to keep other test records (NRC is 3) 31.5 (c) (4) (i) not listed out (NLO)
- 31.5 (c) (7) not found 31.5 (d) NRC also
- manufacture "or import" of devices
( added: subject to ... provisions
, 32.51 not found in packet 4
i C-12
. - - . --- . _ . . - -. --. . . -.~ . _. - . .- -.
GL Comparison with NRC Regulations State: lowa State Agency: lowa Dept of Public Health Address: Lucas State Office Bldg.,4th Floor Des Moines, IA 50319-0075 ;
Contact:
Donald A. Flater l Bureau of Environmental Health l 515-281-3478 FAX 515-242-6284 fees: none (fee regs set as "equiv to NRC")
additional tracking / reports: phone survey about every 5 years 31.5 (a) added: "own" *
- sub: " radioactive" 31.5 (b) NRC also " initially transfer" *
- added: FDA provisions J1.5 (c) (4) sub: 1/1/2 years !,
31.5 (c) (7) not found 31.5 (d) NRC also: "or import" added: additional state provisions 32.51 (a) (3) (iii) second format choice 32.52 (c) NRC also: " keep records 5 years" l
4 C-13
l l
~
GL Comparison with NRC Regulations State: Kansas State Agency: Kansas Department of Health and Environment Division of Environment Bureau of Air and Radiation 4
Radiat!on Control Program 2
Address: 109 SW 9th Street, Suite 602 Topeka,KS 66612-1274 inepec+ ions: all GL (except in-vitro, I think) are on a Priority V reinspection freq of
" catch as catch can" additional tracking / reports:
computer database program- license data entry form, info on
- GL: G licensee, contact, vendor, device type, # units transferred, isotope, activity per device, model number, transfer 4
date, inspected Y/N?, memo 31.3 NRC also: "own, receive," *
- sub: " radioactive" (NRC uses byproduct) 31.3 (a) sub: " ionization of air" (NRC has "use as static eliminators") *
- sub:
, " radioactive" (NRC uses byproduct) i 31.3 (b) *
- sub: " radioactive" (NRC uses bypr. duct) added: subject to ..... provisions l
, 31.5 (a) added: " Subject to the provisions of subsection (b) and (c) of this !
regulation," (refs to the remainder of 31.5) *
- NRC also: hereby issued "to 1 i commercial and industrial firms and research, educational and medical institutions, .
individuals in the conduct of their business, and Federal, State or local government l agencies" 31.5 (b) *
- sub: " radioactive" (NRC uses byproduct) *
- NRC also: "or initially l transferred" 31.5 (c) NRC also: " receives, transfers," *
- sub: " radioactive" (NRC uses byproduct) 31.5 (c) (4) sub: "shall" (NRC uses must) *
- 1 year to keep leak test records (NRC is 3) *
- 1 year to keep on-off test records (NRC is 3) *
- 2 year to keep other test records (NRC is 3) ,
31.5 (c) (4) (i) not listed out (NLO) i 31.5 (c) (4) (ii) NLO C-14
1
.. 4 31.5 (c) (4) (iii) NLO' f
31.5 (c) (7) - not found i 31.5 (d) NRC also: "or import" j
32.51 not found in packet f
i i
r I
E P
?
4 h
I t
n r
?
f P
1 l
[
b i
?
' C- 15 l
l i
GL Comparison with NRC Regulations i State: Kentucky i State Agency: Department for Health Services Cabinet for Human Resources Commonwealth of Kentucky l l
Address: Frankfort, KY 40621-0001
Contact:
Vicki D. Jeffs, Supervisor Radioactive Materials Section Radiation Control Branch (502) 564-3700 fees: categories: (1) gauges (2) electron capture detectors (gas chromatograph)
(3) static eliminators (4) exit signs (5) other devices (misc) *
- initial and annual fee of $75 except for exit signs inspections: except exit signs, try to inspect each GL at least one time additional tracking / reports: quarterly reports from manufacturers and distributors, then form letter sent with fee notification if required, GL terminated upon proper notification of return of device other: says that some of the problems are due to changes in licensee personnel, infreq of inspections by reg agency, dict /manuf oversights or mistakes in reporting 31.3 sub: " radioactive" for byproduct 31.3 (a) sub: " radioactive" for byproduct 31.3 (b) sub: " radioactive" for byproduct added section on more provisions 31.5 (a) no " federal" " sub: " radioactive material, excluding special nuclear material" (NRC uses byproduct) 31.5 (b) sub: " radioactive" (NRC uses byproduct) ' NRC also: "or initially transferred" *
- 902 KAR 100:058 same as 32.51? ' added: about Fed Food, Drug and Cosmetics Act 31.5 (c) added: " owns" " sub: " radioactive" (NRC uses byproduct) 31.5 (c) (3) missing: about shall assure that the tests in (c) (2) (i) and (ii) are performed:
C-16
31.5 (c) (4) sub: "shall" (NRC uses must) *
- 1 year to keep leak test records (NRC is 3) " 1 year to keep on-off test records (NRC is 3) *
- 2 year to keep other test records (NRC is 3) 31.5 (c) (4) (i) not listed out (NLO) 31.5 (c) (4) (ii) NLO 31.5 (c) (4) (iii) NLO 31.5 (c) (7) not found 31.5 (c) (8) sub: " radioactive" for byproduct ,
31.5 (d) NRC also: "or import"
- added: subject to .... provisions 32.51 not found in packet t
e C-17 1
GL Comparison with NRC Regulations State: Louisiana :
) State Agency: Radiation Protection Division
- Office of Air Quality & Radiation Protection l Address: 7290 Cluebonnet Road l 2nd floor PO Box 82135
- Baton Rouge, LA 70884-2135 i
, 1
Contact:
Jim Sanford 504-765-0138 FAX 504-765-0222 a
l 31.5 (a) adueu: "own" *
- sub: " radioactive" 31.5 (b) NRC also " initially transfer" *
- added: FDA provisions 31.5 (c) (4) sub: 1/1/2 years l 31.5 (c) (7) not found j 31.5 (d) NRC also: "or import" added: additional state provisions 32.51 (a) (3) (iii) second format choice 32.52 (c) NRC also: " keep records 5 years" C-18
-i
- GL Comparison with NRC Regulations i State
- Mississippi i State Agency: State Dept. of Health i
! Division of Radiological Health '
Address: 3150 Lawson Street P.O. Box 1700 Jackson, MS 39215-1700 ,
Contact:
Jonathan F. Barlow Health Physicist Sr.
(601) 354-6657 fees: $150/ year :
inspections: 4-5 years additional tracking / reports: forms sent from 1/4fy rpts {
l 31.5 (a) added: "own" *
- sub: " radioactive" 31.5 (b) NRC also " initially transfer" *
- added: FDA provisions H 31.5 (c) (7) not found 31.5 (d) NRC also: "or import" added: additional state provisions 32.51 (a) (3) (iii) second format choice 32.52 (c) NRC also: " keep records 5 years" I l
C-19
GL Comparison with NRC Regulations State: Nebraska State Agency: Division of Radiological Health !
State Dept. of Health Address: 301 Centennial Mall South, 3rd floor PO Box 95007 Lincoln, NE 68509
Contact:
Mr. Harold R. Borchert, Director i I
i 31.5 (a) added: "own" *
- sub: "ra:ficactive" {
31.5 (b) NRC also " initially transfer" l 31.5 (c) (4) (i) till disposal 31.5 (c) (1) (ii) till disposal {
31.5 (c) (4) (iii) 2 years 31.5 (c) (7) not found 31.5 (d) NRC also: "or import" j added: additional state provisions l
32.51 (a) (3) (iii) second format choice l
32.52 (c) NRC also: " keep records 5 years" !
added: RSO training requirements ;
I i
C-20
d
, GL Comparison with NRC Regulations
) State: Nevada !
State Agency: Bureau of Health Protection Services Dept. of Human Resourcec State of Nevada ,
Address: 505 E King Street, Room 101 Carson City, NV 89710
Contact:
Stanley R. Marshall, Supervisor Deputy Food & Drug Commissioner Radiological Health Section (702)687-5395 FAX (702)687-5751 31.5 (a) added: "own" *
- sub: " radioactive" 31.5 (b) NRC also " initially transfer" added: additional state provisions 31.5 (c) (4) (i) till disposal 31.5 (c) (4) (ii) 1 yr 31.5 (c) (4) (iii) 2 yr 31.5 (c) (5) NRC also: "and remedial action taken" 31.5 (c) (7) not found 31.5 (d) NRC also: "or import" 32.51 (a) (3) (iii) second format choice 32.51 (b) not found 32.52 (c) NRC also: " keep records 5 years" C-21
l GL Comparison with NRC Regulations State: New Mexico State Agency: Health and Environment Dept.
Environmental improvement Division Community Services Bureau Radia: ion Licensing and Registration Section State of New Mexico Address: 1190 St. Francis Drive PO Box 26110 Santa Fe, NM 87502-6110
Contact:
Mr. Benito Garcia, Chief 505-827-4358 FAX 505-827-4361 31.5 (a) added: "own" *
- sub: " radioactive" 31.5 (b) NRC also " initially transfer" *
- added: FDA provisions 31.5 (c) added: "own" 31.5 (c) (4) sub: 2 years 31.5 (c) (7) not found 31.5 (d) NRC also: "or import" added: additional state provisions 3152 (c) NRC also: " keep records 5 years" C-22
b GL Comparison with NRC Regulations State: New York State Agency: State of New York Department of Labor Division of Safety and Health Radiological Health Unit Address: One Main Street Brooklyn, NY 11201
Contact:
Rita Aldrich Principal Radiophysicist (718) 797-7642 fees: they are requesting annual fees in 1994-1995 appropriations bill, but do not know if it will be approved other: regs imp!icitly require that only devices which are to be permanently installed in a given location can 've received as a GL 31.3 added: "or imported" added: -
Terms and conditions: not combine or increase the isotopes AND not use on humans comply with listed sections 31.5 (a) NRC also: "to commercial and industrial firms... gov't agencies" *
- NRC also: " transfer" *
- added: "own" *
- NRC has comma " level, interface location" *
- added: description of label added: reporting receipt of a GL 31.5 (c) (2) (ii) NRC also; ... beta or alpha and held in original shipping container..."
1 31.5 (c) (4) missing '
31.5 (c) (7) missing 31.5 (c) (8) NRC also "no report for replacements" l 31.5 (c) (3) (ii) missing 31.5 (d) missing 32.51 not found in packet C-23 i
i
GL Comparison with NRC Regulations State: North Carolina State Agency: State of North Carolina Dept. of Environment Health, and Natural Resources Division of Radiation Protection Address: PO Box 27687 Raleigh, NC 27611-7687 919-571-4141 FAX 919-571-4148
Contact:
J. Robin Haden, Chief Radioactive Materia's Section fees: $75 annual, except for exit lights inspections: about 1/4 of their monthly insp are GL, freq: industrial gauges is 3 years and others are 4 yrs, exit lights not insp unless they have another license additional tracking / reports:
- 1. receipt of 1/4 reports
- 2. acknowledgements / deficiency letters to distr.ibutors
- 3. - new GLs sent a form and cover letter
- current GL sent a form to update
-if have specific license, given opp to add GL to it
-if have a terminated GL, sent form to reactivate it
- facility issued a GL# specific to their facility
- second letter sent if no answer in 30 days 31.5 (a) added: "own" *
- sub: " radioactive" 31.5 (b) NRC also " initially transfer" *
- added: FDA provisions 31.5 (c) (3) (i) added: "GL can do leak test kit if use a kit provided by someone with specific license to provide leak test kit services 31.5 (c) (4) sub: 1/1/2 years 31.5 (c) (7) not found 31.5 (d) NRC also: "or import" *
- added: "or distribution" added: additional state provisions 32.51 not found in packet C-24
GL Comparison with NRC Regulations State: Rhode Island State Agency: Rhode Island Dept. of Health Radiation Control Agency Address: 206 Cannon Bldg 3 Capitol Hill Providence, Rl 02908-5907
Contact:
Roger Marinelli, Chief Division of Occupational and Radiological Health 401-277-2438 FAX 401-277-2158 31.5 (a) added: "own" *
- sub: " radioactive" 31.5 (b) NRC also " initially transfer" *
- added: FDA provisions 31.5 (c) added: "own" 31.5 (c) (3) NRC also: " tests required by (c)(2)" and other tests 31.5 (c) (4) sub: 1/1/2 years 31.5 (c) (7) not found 31.5 (d) NRC also: "or import" added: additional state provisions -
32.51 (a) (3) (iii) second format choice 32.52 (c) NRC also: " keep records 5 years" C-25
l 1 ,
4 i
GL Comparison with NRC Regulations l
State: Tennessee i State Agency: Tennessee Dept. of Health and Environment Division of Radiological Health Address: L&C Annex,3rd floor 401 Church Street Nashville, TN 37243-1532
Contact:
Johnny Graves 615 532-0364 615-532-0614 l
31.5 (a) added: "own" *
- sub: " radioactive" 1 31.5 (b) NRC also " initially transfer"
)
31.5 (c) (4) no mention of how long to keep 31.5 (c) (7) not found 31.5 (d) NRC also: "or import" added: additional' state provisions 32.51 (a) (3) (iii) suond format choice 32.52 (c) NRC utso: " keep records 5 years" C-26
49 e
GL Comparison with NRC Regulations State: Texas State Agency: Bureau of Radiation Control Texas Dept. of Health Address: 1100 West 49th Street Austin, TX 78756-3189
Contact:
Mr. David K. Lacker, Chief 512-834-6688 FAX 512-834-6690 fees: $200 initial only (but says that it expires on the date listed on the GLA, no mention of how long they are good for) additional tracking / reports: GLA General License Acknowledgement other: notice * *
- for producing light or an ionized atmosphere - is not under 31.5(a), is listed under 31.3 with the static eliminator and ion generator tubes but it adds additional requirements for th 6 31.5 (a) sub: " radioactive" *
- NRC also " light / ion atm producing" added: and owe no delinquent state business tax 31.5 (c) (3) (i) not found 31.5 (c) (4) no ref on how long to keep added: maintain:
- 1. assignment records for portable / mobile devices including serial
- , location, dates assigned to location, kept both at the address in the GLA and at the temporary site L copy of the operating and instruction manual at each temp site 31.5 (c) (7) not found 31.5 (c) (8) NRC also: "no need to report if returned for a replacement" 31.5 (c) (10) not found 31.5 (d) NRC also: "or import" added: additional state provisions 32.51 not found C-27
l GL Comparison with NRC Regulations State: Utah State Agency: Division of Radiation Control Utah Dept. of Environmental Quality Address: 168 North 1950 West PO Box 144850 Salt Lake City, UT 84114-4850
Contact:
Susan Giddings, Health Physicist 801-536-4250 FAX 801-531-8218 l
l l
inspections: used to investigate non-responders (new and current registrants) with on-site insp of address in 1/41y report additional tracking / reports:
letter notifying manuf of their resp to report to state of transfers into l state device notification letter - says we have been notified that you received a GL device, fill out form and send in with fee, registration certificate issued dbase to track GL GL survey with cover letter and rules - seems to be sent to all in dbase
- freq unknown 31.5 (a) added: "own" *
- sub: " radioactive" 31.5 (b) NRC also " initially transfer" *
- added: FDA provisions 31.5 (c) added "own 31.5 (c) (4) sub: 1/1/2 years 31.5 (c) (7) not found )
31.5 (d) NRC also: "or import" added: additional state provisions 32.51 not found C-28
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amoroacerva navrees l Manwoon so: working aroup -
a FRM: - Joel O. Ta*w=mu working Group axhair L RE: INIUBRTION TAGET: W3KIE GROUP QWUHt, BAOCROUND MmRIAIS AND REFEREN3S
(
j Attached is an information packet for the joint Ag-st State-NRC working j Group (WG) to review the regulation of devices containing radinar+lve j material.
As you know, the Manion approved formation of the WG in June,1995. The.
3 WG was formed 21 August,1995 and NRC staff estimated that one year would be rwwiad for the WG to cxmplete its work. The p .-sit plan calls for a series I
of five meetings of the WG between C-$.-2+r,1995 and April,1996. including a
.public workshop in January, 1996. As you can see frun the WG charter, the goal is to prninem a final WG report by May,1996.
Our first meeting will be held at the NRC Iw=imarters Mtite Flint North i couplex beginning 8:30 am,14=aday, Mr*=r 24th and eruling the morning of.
Shursday, nr+<*=r 26, 1995. The meetings will be publicly announced j 'beforehand and will be open to the public. A copy of the'announomumt of the :
i meeting has been made available to professional and trade organizations and to -
i others that may be interested in the WG activities. Please feel free to make
{ further distribution. If you cannot attend the meeting, please let either co-chair Bob Free or me know.. State WG members should contact the NRC Office l of State sws.c-= for fiar-al information on travel support.
) The attadummits include:
- i. 1. WG Omrter j 2. Public armour---,.-il of WG meeting i 3. Draft meeting agenda (nrmmerits requested) j 4. SECY-95-139 and Staff Requirenents Memo dated 20 June 1995 (which !
{ created t]w WG)
- l
[ 5. Papers by J. Inbenau and J. Yusko "Radinae+ive materials in recycled l metals," ]1ealth Physics 68:440-451 and +w--- nying editorial-(April-t- 1995), arul "3he continuing problem of radinae+1ve scrap metal,"
i Bggaglias of the 27th Anrmal Conference on Radiatirwt control (in i print)
! 6. Federal Register Notice re g --W rulemekirxy for GL devices, 56 3 l j; 67011 (26 <iarw=dwr 1991)
- 7. Draft SBCY to finalize r-,-M rulemaking for GL devices (undated) !
- j. 8. Report, "Japroper transfer /di==al scenarios for generally licensed ,
j devices," prepared by Oak Ridge Associated Universities (April 1987) l
}. 9. " Draft report on survey of general licensees under 10 CFR 31.5,"
prepared by ICF Inc. ' (nnmanhar 1990) l 10. "Tedinical letter laru.L: Task 7, final review of the 1987 report by Oak 2
l -
I f O'^2^l" 12 p p . i
,+ - -
. . . . - - . . . . _ . . . . -.. - -.~ . . . . . - . . . . . .- .._
3 e
i ..
~( Workire Group 2 I
i
- 10. "Tecimical letter iq;vti: Task 7, final review of the 1987 igan.L by Oak Ridge Associated Universities...," prepared by Pacific Northwest
- Tahnratories (3 June 1994).
I apologize for the volume of material, however, it was felt that endt of the attad =iw is gersane to our task. Itans 1-4 are self-explanatory. Itan 5 includes the most recent published Aq;utw on the iM of the problea.
^
Itans 6 & 7 relate to a NRC p-;-ml to i& additional requirements on general liceiv:ar*. 'Diis Ex-; - e-i rulesnaking was referred to by Jim Yusko and me in our Health Ihysics paper. 'Ihe draft final rulanaking package (iten 7 was never and=itted because of Ismemue ==Lenints as reported in our paper).
Items 8,9 and 10 are NRC reports of NRC sponsored studies that attempted to shed light on the GL prwtam.
If additional 13;vtLs or references are identified that would be useful to the NG, please bring them to the attention of either Bob Free or me. We will endeavor to make them available to the WG.
We have a famichble challenge ahead of us but I look forward to workiry together with you to meet it!
Attachments: As stated oc w/atts.:' WG Cb-chair R. Free Wg r.inic.nns W. Iahs, )#1 C. Ryder, RES F. G-im, OGC R. Bangart, OSP NRC Public M w nt Room cx: w/att.2: W. Amrher, OPA I
i i
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.- UNITED STATES
( } NUCLEAR REGULATORY COMMISSION I j
q g*...*je WASHINGTON, D.C. 20065-0001
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- Joint Agreement State-NRC Working Group I i To Evaluate Control and Accountability of Licensed Devices l
1 I.
! CHARTER
) Scope i A working group of Federal and State regulators is to evaluate ,
4 current regulations concerning the control of and accountability l for generally and specifically licensed devices and develop recommendations for alternative regulatory approaches, as appropriate, taking into consideration the costs of any recommended changes. A part of the effort should be devoted to definirg a method of measuring the effectiveness of the current and proposed programs.
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Background
On June 20, 1995 the Commission approved a staff plan to contact the Organization of Agreement States (OAS) to form a working l
group (WG) to evaluate current regulations concerning generally i and specifically licensed devices.
The Problem i
Inadequate control of licensed devices by licensees has lead to radioactive materials being included in metal scrap intended for recycling. Inadvertent smeltings of radioactive materials in '
mills have occurred resulting in contamination of mills, mill products and byproducts. Subsequent costs for each incident that l required decontamination, waste disposal and mill shutdown have totaled as much as $ 23 million. While exposures to radiation :
from radioactive sources in metal scrap in the U.S. have been '
minimal, significant radiation exposures of workers and the public resulted from incidents which occurred in Mexico and in ;
Estonia, in the latter case causing one death. "Near-misses" '
have ur occurred in the U.S.: In 1994-95 an unshielded 14 GBq (370 l aci) cs source was found buried at a scrap yard in Illinois, a 12GBq (330 sci) 07Cs became separated from its unielded holder when the holder went through a shredder at a scrapyard in Kentucky, and uTCs contamination of soil was found at a scrapyard in Michigan.
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While various types of radioactive material have been found in metal scrap, the principal source of concern are devices such as nuclear gauges. Under NRC regulations specifically licensed gauge users are subject to annual fees and a schedule calling for inspections every 5 years while general licensees are not subject to fees nor to routine inspections.
The Task The task of the WG is to assess the current regulatory programs for generally and specifically licensed devices and determine the baseline.for regulating these devices. The assessment should address the question of whether there is an adequate level of assurance that these devices are properly controlled and accounted for by licensees, and that they do not present unacceptable levels of risk of exposure to radiation to workers and the public or financial risk to the metal recycling industry.
An integral part of this assessment is to determine how to measure the success or failure of a regulatory program. The WG should examine regulatory alternatives including the costs of the alternatives for device vendors and users, the regulating agencies and other potentially affected groups and provide a recommendation to the Commission.
The Issues Seven issues were identified by NRC staff that require a coordinated Agreement State and NRC review, i.e. addressed by the ,
WG: I
- 1. NRC and Acreement State Comoatibility -- NRC and Agreement State regulations need to be compatible since approximately 2/3 of the devices are used by Agreement State licensees and loss of a device will often have effects in States other than the licensing State.
- 2. Cost and Fee Considerations -- There are various options for licensing devices that would provide better control and accountability. The cost of implementation to the NRC and Agreement States and the appropriate cost recovery method need to be considered.
- 3. Radiation Exposure Savinos -- The savings in radiation exposures resulting from better control over, and accountability for, devices need to be considered in the selection of the method for licensing of devices.
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- 4. Device Desian -- Currently, the design requirements for j generally licensed devices are more stringent than those for specifically licensed devices. The safety impact of using a different licensing method, which may rely on administrative controls rather than the design of the devices, must be evaluated.
- 5. Chances That Affect All Devices Versus Oniv Newiv Acauired Devices -- Since there are currently about 1.5 million generally licensed devices in NRC and Agreement States, changes in the licensing of devices need to address both new requirements for
- devices currently possessed by licensees and newly acquired devices.
- 6. Device DisDosal -- Options for the disposal of devices need to be delineated. Many current general licensees may wish to
- dispose of the devices rather than be subjected to increased
, regulation.
- 7. Device Identification -- Added requirements to ensure that methods of identification are used that could better withstand harsh, unexpected environments. Such requirements may enhance the ability to identify devices that are disposed of or 4
improperly transferred.
In addition to these issues the WG should also answer the following question which is central to evaluating both the present regulatory program and any contemplated changes:
How can the success (or failure) of a regulatory program for ensuring adequate control and accountability of licensed sources be most effectively measured?
l Committee Oraanization and Orerations
- Joel O. Lubenau, Senior Health Physicist, NMSS/IMNS/SCDB and Robert Free, Branch Administrator, Emergency Response and Incident Investigation, Texas Bureau of Radiation Control have been named WG co-chairs by the NRC and OAS respectively. Other OAS members are Martha Dibblee, Manager, Radioactive Materials i i Program, Oregon Radiation Protection Services, J. Robin Haden, Chief, Radioactive Materials Section and Rita Aldrich, Principal Radiophysicist, New York State Department of Labor (alternate).
Other NRC members are Lloyd A. Bolling, Office of State Programs and John L. Telford, Office of Nuclear Regulatory Research.
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!* Tha Conference of Radiation Control Program Directors, Inc.
l' (CRCPD) has tasked its E-23 Committee on Resource Recovery and Radioactivity to review the issue of radioactive materials in metal scrap and develop recommendations. The committee has worked closely with the metal recycling industries and State and sd Federal agencies to develop guidance particularly for educational efforts and protective measures. The WG co-chairs will request the CRCPD to designate an E-23 representative to serve as liaison
! to the WG.
2 The International Atomic Energy Agency (IAEA) has reported on the i problem of assuring adequate controls and disposal of " spent" i radiation sources, i.e., sources that are no longer needed or j
usable. The NRC co-chair will request the NRC Nuclear Safety Attache assigned to the U.S. Mission to the UN System Organizations (James Richardson) to serve as liaison to the WG, The co-chairs will be jointly responsible for developing a work j plan for the WG, monitoring progress, preparing minutes of WG minutes and drafting a report of the WG's work and l recommendations. Secretarial, logistical and travel support for i WG meetings will be provided by the NRC. WG meetings are not j subject to the requirements of the Federal Advisory Committee Act
! (FACA) but they will be publicly announced in advance through the j- NRC Public Meeting Notice System. Maximum use will be made of j other appropriate media, e.g., professional and trade 3
newsletters, to announce meetings to as broad an audience as i possible. WG meetings will be open to the public and will be ~,
- held in the Washington,.DC area. NRC will fund the travel and
, per dien costs for the OAS co-chair and'two additional OAS j members. The CRCPD liaison is welcome to attend all meetings but NRC will not fund the travel costs.
Persons attending WG meetings will be welcome to provide comments l j to the WG for its consideration in either written form or orally 1
at times specified by the WG co-chairs. A public workshop will i be held to enable stakeholders to participate more directly in i this process. The WG will be responsible for developing a plan i for the workshop. NRC will provide the logistical and associated i funding support for the workshop. The workshop will be held in
- the DC area. ;
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Taraets and Milestones Meetings of the WG are blocked out as follows:
Meetina week of Notes Oct 23, 1995 Scheduled for October 24-26, 1995.
Initial i 2nd Dec 11, 1995 Jan 15, 1996 Public workshop 3rd Mar 11, 1996 Review draft WG report
.4th Apr 15, 1996 Finalize WG report 5th other key dates:
Activity Date April 14-19, 1996 IRPA Congress May 5-10, 1996 CRCPD Annual Meeting l
June 24, 1996 NRC staff report to the EDO l
l (Target date)
July 21-25, 1996 HPS Annual Meeting ,
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( g E E
UNITED STATES NUCLEAR REGULATORY COMMISSION g, ...../ WASHINGTON, D.C. 20555-0001 CEGGE IN LOCATION! SEE PAGE 2!
September 20, 1995 Revised Notice of Public Meeting -
On June 20, 1995 the U.S. Nuclear Regulatory Commission approved formation of a joint NRC-State Working Group to review the regulatory program for radioactive material contained in devices.
The primary factor for this decision is the occurrence of radioactive materials mixed with metal scrap intended for recycling. In the United States there has been 24 instances where radioactive sources were accidentally smelted with metal scrap causing contamination of manufacturing mills and their products. Resulting costs for have been as high as $23 million for a single incident. Serious injuries caused by exposure to radiation in the U.S. have not been documented but overseas, a large radioactive source that became mixed with metal scrap resulted in one death and radiation injuries to others.
'A Working Group of Federal and State regulators is to evaluate current regulations concerning the control of and accountability for generally and specifically licensed devices and develop recommendations for alternative regulatory approaches, as appropriate, taking into consideration the costs of any recommended changes.
The Working Group will be co-chaired by Robert Free of the Texas Bureau of Radiation Control and Joel O. Lubenau, NRC. Other State members of the Working Group are Martha G. Dibblee, Oregon Radiation Protection Services, Robin J. Haden, North Carolina Division of Radiation Protection, and Rita Aldrich, New York State Department of Labor Principal Radiophysicist (alternate).
Other NRC members are Lloyd A. Bolling, Office of State Programs and John L. Telford, Office of Nuclear Regulatory Research.
Preliminary plans call for a series of meetings of the Working Group beginning in October, 1995 including a public workshop in January, 1996. The workshop will provide an opportunity for direct input by stakcholders potentially affected by this review, e.g., the metal scrap recycling industry and mill operators, device manufacturers, and users of licensed devices. A target date of May, 1996 has been set for the Working Group to develop and finalize its recommendations.
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. All meetings of the Working Group will be publicly announced and open to the public. The first meeting has been tentatively scheduled for October 24-26, 1995 in Rockville, Maryland beginning on Tuesday, October 24th at 8:30 am.
4 CHANGE IN LOCATION!
The first meeting will be held at the Doubletree' Hotel, 1750 Rockville Pike, Rockville, MD 20852. The hotel is readily accessible from the Twinbrook Station on the red line of the Metro. The telephone number is 301-468-1100.
Meeting times and rooms are:
Tuesday, October 24, 1995, 8:30 am - 5:00 pm Wednesday, October 25, 1995, 8:00 am - 5:00 pm Thursday, October 26, 1995, 8:30 am - 10:30 am
. Randolph Room Doubletree Hotel 4
i CIMNGE IN LOCATION!
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i Information on this meeting and future meetings will be
! available to the public:
o by telephone recording on the toll-free NRC Public Meeting Announcement System, 1-800-952-9674, o on the toll-free electronic bulletin board,1-800-952-9676, and l o in periodic postings in the Public Document Room and Local Public Document Rooms.
l Information may also be obtained toll ~ree at NRC at FedWorld, 1-800-303-9672, access through the GATEWAY option.
The NRC contact is Joel Lubenau, Office of Nuclear Materials Safety and Safeguards. He can be reached by telephone at 301-415-7910, by fax at 301-415-5369 and by e-mail at JOL@NRC. GOV.
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4 JOINF AGREEMINF STATE-NRC WCRKDIG GROUP TO IGVIDi 'IHE REWIATIN OF IEVICES 03fIAINING RADIOACTIVE MATERIAIB (Working Group) J Draft Aaenda j October 24 26. 1995 i a
) OtH: hairs: Robert Free, Texas Dept. of Health Joel inharunt, NRC Office of Nuclear Materialm ;
1 Safety ard Safeguards Mmhars: Martha Dibblee, Oregon Dept. of }kanan Raarances j Robin Haden, North Carolina Dept. of Envircrement, I 4
Health and Natural Resources
- Rita Aldridi (alternate), New York State Department i of Labor l Lloyd Bolling, NRC Office of State Pruga-1 John Telford, NRC Offi of Nuclear Regulatory Researdt
- Liaisons
- Ja m Yusko, 01 airman, Resource Recovery and l
. Fadimr+1vity rwrunittee, Conference of i
. Radiation Control P m p.am Directors j James Ridiardson, NRC Nuclear Attache, International Atruir' Energy Agency
)
'Dwadav. October 24, 1995 8:30 - 9:15 am Call to Order Cb-chairs 9:15 - 9:45 am Introductory RE5 Harks Carl Paperiello, Director, NRC Office of Nuclear Safety and Safeguards 9:45 - 10:15 am Break 10:15 - 11:30 am Overview: Radioative Materials in %uled Metala James Yusko 11:30 - 1:00 pn 112ndi 1:00 - 2:00 pn NRC Reglatory Approadt for Radime+3ve Materials in Devlees John Telford Office of Enforcuis.nt Representative 2:00 - 3:00 pn Alternative Approacher By the A + d. States
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l Lloyd Bolling l atin en -
Martha Dibblee i Robert Free 3:00 - 3:30 pn Break 3:30 - 4:45 pn Opportunity for Public Ctunnent: t o are the Stakeholders?
Co-chairs 4:45 - 5:00 pn >genda Plannirg for Wednesday Co-chairs I
! Wednesckw, October 25, 1995 8:00 - 8:30 am International lbrspectives Jim Richardson
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8:30 - 10:00 am Di< m cion: Working Group Charter and Meeting Schedule 4 Ocy-diairs 4
10:00 - 10:30 am Break l l
10:30 - 11:30 am Discussion: Public Workshop Plannirri Cb-chairs 11:30 - 1:00 pn Innch 1:00 - 2:00 pn Discussion: Public Workshop Planning co-chairs ;
I 2:00 - 3:00 pn Opportunity for Public Ci .=ud. !
l Cb-chairs i 3:00 - 3:30 pn Break j 3:30 - 4:45 pn Discussion: Otusmications, Working Group Tasks, Assignments and Milestones Cb-chairs 4:45 - 5:00 pn Agenda Planning for 'Ihursday a
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l 8:30 - 10:30 am Wrap-up D1srsmions:
Charter ard Meetirq S6arhile Public E= M acp i Ctmuunicatiers, Tasks, Assiy ==(w and Milestmes h irs 10:30 am Mjouu === st i
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- 'o UNITED STATES g NUCLEAR REGULATORY COMMISSION
[ W ASHIN GTON, D.C. 20555 n y
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OFFICE OF THE JUN 2 01995 SECRETARY ;
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MEMORANDUM TO: James M. Taylor l I
ExecutWve Director for Operations FROM: Jol n . H etary 1
SUBJECT:
SECA 13 9 - STAFF REQUIREMENTS - COMGD ;
003 - IMPROVING NRC'S CONTROL OVER, AND '
LICENSEES ACCOUNTABILITY FOR, GENERALLY AND SPECIFICALLY LICENSED DEVICES This is to advise you that the Commission has not objected to staff's plans to contact the Organization of Agreement States to initiate formation of a working group to evaluate current regulations concerning generally and specifically licensed devices.
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cc: The Chairman Commissioner Rogers Commissioner de Planque Commissioner Jackson ..
OGC OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
SECY NOTE: THIS SRM AND SECY-95-139 WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.
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i POLICY ISSUE (NEGATIVE CONSENT)
May 31, 1995 SECY-95-139 fQB: The Cosmiissioners 4 ffME: James M. Taylor Executive Director for Operations i
SUBJECT:
STAFF REQUIREMENTS - COMGD-94-003 - IMPROVING NRC' S CONTROL OVER, AND LICENSEES' ACCOUNTABILITY FOR, GENERALLY AND SPECIFICALLY 4
LICENSED DEVICES
) PURPOSE:
l To respond to the Staff Requirements Memorandum of October 18, 1994, (copy
! included as Attachment 1), which requested that the staff develop j recommendations for future actions to improve general licensees' control over, and accountacility for, generally licensed devices used under 10 CFR 31.5. In developing the recomunendations, the staff was instructed to explore the
- problem of accidental smeltings of devices containing byproduct material. It i has become clear that the recommendations should also encompass similar
- devices used under a specific license. Staff intends to form o Working Group 1 with Agreement State representation to evaluate the current regalations
- concerning generally and specifically licensed devices.
BACKGROUND: ..
l The Steel Manufacturers Association (SMA) has reported various incidents j involving the accidental smeltings of devices containing byproduct material.
i The devices involved were transferred to SMA facilities through various i mechanisms. However, the root cause of these devices making it into the smelting process has been Nuclear Regulatory Consiission and Agreement State
- general and specific licensees' loss of control and accountability for the devices.
NOTE: TO BE MADE PUBLICLY AVAILABLE WHEN THE FINAL SRM IS MADE
! AVAILABLE
Contact:
l John W. Lubinski, NMSS 4
- 415-7868 e
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l The Commissioners l l The NRC has learr.ed, through performing surveys and studies of general
- licensees, that many general licensees are not aware of their responsibilities j under the general license. This has led to general licensees improperly
- transferring or disposing of byproduct material and could result in persons j working at generally licensed facilities receiving unnecessary exposures.
I To make general licensees more aware of their requirements under the general l
license and to ensure accountability of the material used under the general j license, NRC staff determined that more frequent contact with general licensees is necessary. It was determined that the most efficient form of 2 contacting general licensees would be by mail. On December 27, 1991, a proposed rule, t' ne inventory rule, was published,.which would provide a mechanism for contacting all existing and future general licensees. The resources associated with the rule were estimated to be $350,000 in contract funds per year and five full-time equivalents (FTE) per year between Headquarters and the regional offices. The staff prepared a final rule that was slightly revised and expanded as a result of comments received from the public. However, due to limited resources, the rulemaking was placed on hold on December 29, 1993.
The staff also developed and published a proposed r'ule that addressed the design of certain generally licensed devices. The-proposed rule was published :
on November 27, 1992, and included limiting the size of the accessible air gap ' !
and/or limiting the dose rate within the radiation beam of certain generally '
licensed devices. The staff has reviewed the comments received concerning the ,
proposed rule. However, implementation of the rule requires contacting '
existing general licensees to determine if they are affected by the change and to verify that those affected have modified their devices to meet the new i rule. The resources for cosumnicating with the general licensees were included in the resources bu:4eted for the inventory rule. Since these l resources are not available, this rulemaking has also been placed on hold.
DISCUSSION:
1 There are approximately 1.5 million generally licensed devices in Agreement States and areas of NRC jurisdiction. Approximately 450,000 of these devices are regulated by NRC. Because of the large number of generally licensed devices and low risk associated with many of the devices, the staff is investigating whether some of the persons using devices under a general license can be exempted from licensing requirements based on the type of device they possesi. The Office of Nuclear Regulatory Research has employed the services of a contractor to study the feasibility of providing such an exemption. The exemption would relieve certain existing general licensees from the reporting, record-keeping, testing, and disposal requirements associated with use of the devices under a general license. Approximately 60,000 of the approximately 450,000 devices currently licensed under an NRC general license may fall into this category.
The staff has conducted an extensive review of the issues involved in the control over, and accountability for, generally licensed devices. The staff has determined that the same issues apply to control over, and accountability
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- The Commissioners
i i for, similar devices used under a specific license. Seven issues, which are I listed below, were identified during the staff's review and will require a
' coordinated NRC and Agreement State effort to address the broader national issue of control over, and accountability for, generally and s;cuically i licensed devices.
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- 1. NRC and Agreement State Compatibility -- NRC and Agreement State
! regulations need to be compatible since approximately 2/3 of the devices are 4
used by Agreement State licensees and loss of a device will often have effects in States other than the licensing State. .
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- 2. Cost and Fee Considerations -- There are various options for licensing !
! devices that would provide better control and accountability. The cost of l 1
implementation to the NRC and Agreement States and the appropriate cost l
- recovery method need to be considered. j i
- 3. Radiation Exoosure Savinas -- The savings in radiation exposures resulting from better control over, and accountability for, devices need to be !
considered in the selection of the method for licensing of devices. j
- 4. Device Desian -- Currently, the' design requirements 'for generally licensed devices are more stringent than those for specifically licensed devices. The safety impact of using a different licensing method, which may rely on administrative controls rather than the design of the devices, must be evaluated.
- 5. Chanaes That Affect All Devices Versus Only Newiv Acautred Devices -- Since there are currently about 1.5 million generally licensed devices in NRC and Agreement States, changes in the licensing of devices need to address both new requirements for devices currently possessed by licensees and newly acqcired l devices.
- 6. Device Disposal -- Options for the disposal of devices need to be delineated. Many current general licensees may wish to dispose of the devices :
rather than be subjected to increased regulation. !
- 7. Device Identification -- Added requirements to ensure that methods of i identification are used that could better withstand harsh, unexpected '
er.vironments. Such requirements may enhance the ability to identify devices that are disposed of or improperly transferred.
A more detailed discussion of each of the above seven concerns is contained in i Attachment 2.
The staff has identified a variety of approaches that address control over, and accountability for, generally and specifically licensed devices. At one end of the range of options is a modification of the inventory rule proposed in 1991. This option is to institute a new form of license that would require registration of individual devices. In concept, a yearly interaction, through the mail, would be required, where the licensee would pNvide confirmation regarding the _ device's location and status. The staff has also considered an
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l The Commissioners )
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! option that requires all generally Itcensed devices be available only on a
- lease basis. This option would stipulate control and accountability l requirements on the part of the vendors.
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{ Howe'rer, the staff review concluded that any option or approach recommended by I
- the staff would only address NRC regulated devices and that a national '
i solution must involve the Agreement States. The general and specific l licensing programs need to be analyzed in greater detail to address each of ,
- . the above seven issues and include contributions from Agreement State Program l l personnol. If a national solution is not developed, the changes made to NRC's ;
l Itcensing programs would do little to affect the population as a whole and i would ut necessarily result in a significant increase in the control over, I and accountability for, generally and specifically. licensed devices, which was ;
j the initial motivation for this review prompted by the number of accidental i j smeltings of devices. i i l i The staff believes that 'the most effective way to evaluate these issues from a j national perspective would be to establish an NRC/ Agreement State Working i Group. Since several Agreement States have established programs providing l l greater control over, and accountability for, generally licensed devices, '
i participation by representatives from these States (i.e. 3-6 individual State i representatives) would help ensure a broad level of State input and reflect j their experience. Agreement State participation, and identification of i specific State representatives, will be coordinated through the Organization l t of Agreement States. The staff estimates that the Working Group would take
! approximately one year to complete its work to assess the current licensing programs and to provide recommendations and estimated costs for improving .
these programs. This Working Group would fall within the exemption for
" operational committees" discussed in SECY-94-264, and consequently, would not have to be chartered under the Federal Advisory Committee Act. However, as noted in SECY-94-264, the meetings of such operational committees should be the subject of public notice and should be open to the public. The staff intends to follow these procedures for the Working Group.
RESOURCES:
The staff estimates that the resources necessary to support an NRC/ Agreement l State Working Group would include approximately 1 NRC FTE and $24,000 to cover l travel costs for State participants. Working Group meetings will be held it i NRC Headquarters to minimize expenses. The Office of Nuclear Naterial Safety j and Safeguards is currently budgeted for the NRC FTE.necessary to support the '
Working Group. The resource support necessary from the Office of State Programs and the Office of the General Counsel is expected to be minimal and will be provided through available, budgeted resources. Travel expenses for Agreement State personnel participating in the Working Group will be subsumed in the Office of State Programs' current budget.
REColetE9EATION:
That the Cosmission note that, unless directed otherwise, the staff will, 30 days from the date of this paper, contact the Organization of Agreement i
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The Coamissioners ;
States to initiate the formation of a Working Group to evaluate the current regulations concerning generally and specifically licensed devices. The staff expects it will take 2-3 months to initiate the Working Group, and the group's activities would then take about one year to complete.
- C00RDINATIONt The concepts of this paper were discussed at the Organization of 8greement States' Managers Meeting in April 1995, and at the Conference of Kadiation Control Program Directors' annual meeting in May 1995. Both groups agreed j
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that an NRC/ Agreement State Working Group should be formed to address the 9enerally and specifically licensed device programs.
The Office of the General Counsel has reviewed this paper and has no legal objection.
/ ~
Y s M. T lor ecutive irector a
for Operations i
' Attachments:
- 1. SAM dated October 18, 1994
- 2. Concerns That Need to Be Addressed When Developing a
- Program for Increasing Control Over, and Accountability for, Generally and Specifically Licensed Devices 1
SECY NOTE: In the absence of instructions to the contrary, SECY will notify the staff on Thursday, June 15,assents 1995,
' that the Commission, by negative consent, 4
to the action proposed in this paper.
DISTRIBUTION:
Commissioners OGC OCAA OIG OPA
! MA j
EDO SECY 4
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- pm asa ,, 'o UNITED STATES
- NUCLEAR REGULATORY COMMISSION
- e waswiworos.o.c 20sss
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" * ' O' T"' October 18, 1994 sECRETAR Y MEMORANDUM TO: James M. Taylor E pcutive Director for Operations FROM: b* John C. Hoyle, Acting Secretary f
SUBJECT:
COMGD-94-003 - IMPROVING NRC's CONTROL OVER, t
AND LICENSEES' ACCOUNTABILITY FOR, GENERALLY LICENSED DEVICES The Commission (with all Commissioners agreeing) has approved the following course of action for improving the NRC's control over, and licensees' accountability for, generally licensed devices.
4
- l. The staff should develop interi,m guidelines and associated technical basis, for disposal of 1"Cs in furnace dust resulting from the inadvertent melting of sources. This action should include working'with the Environmental Protection Agency, as appropriate.
- 2. The staff should cooperate with the Steel Manufacturers Association and other appropriate organizations to
! continue attempts to identify the magnitude and character of the problem of radioactive sources turning up in the scrap metal stream.
- 3. The staff should continue to explore the problem of accidental.smeltings of NRC-licensed and Agreement State licensed devices and to deve3op reccamendations for future staff actions in this area. In developing these recommendatio..s, the staff should not rule out options that would involve a third party, e.g. DOE.
Any recommendations should include a cost / benefit analysis and consideration of the limited resources available to the NRC and to Agreement States.
- 4. The staff should inform the Steel Manufacturers Association of the provisions in the draft Federal Radiological Emergency Response Plan (59FR46086) for notifications and assistance in the event radioactive sources are found in the public domain.
(EDO) (SECY Suspense: 4/21/95) u+.4... 3
l cc: The Chairman Commissioner Rogers Commissioner de Planque OGC OCA OIG
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i CONCERNS THAT NEED TO BE ADDRESSED WHEN DEVELOPING j A PROGRAM FOR INCREASING CONTROL OVER, j AND ACCOUNTABILITY FOR, GENERALLY AND SPECIFICALLY LICENSED DEVICES i
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} 1. NUCLEAR REGULATORY C0fetISSION AND AGREEMENT STATE COMPATIBILITY Approximately two-thirds of all generally and specifically licensed devices
- located within the United States are under Agreement State jurisdiction.
,' Therefore, the appropriate level of compatibility with the Agreement States j needs to be determined and established.
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! Historically, the regulations for distribution and use of generally licensed
! devices have been Division 2 levels of compatibility with the Agreement States. This means the States must address the basic principles of the regulations but may adopt more restrictive regulations. A drawback to continuing to have these regulations designated as Division 2 levels of compatibility is that .the regulations covering possession and use of devices may be different, depending on the regulatory jurisdiction. This is significant since the current regulations do not require contacting the regulatory authorities before acquiring a device. Under Division 2 compatibility, distributors of generally licensed devices are required to keep abreast of 30 sets of general license regulations (the Nuclear Regulatory Commission's and the 29 Agreement States' regulations). Differences in current general licensing regulations have led to distributors providing incorrect information to general licensees.
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Changing the regulations to Division I levels of compatibility would mean that the Agreement States would have to adopt the regulations, essentially verbatim, into their regulations. This would not allow the States to adopt more restrictive programs. However, some Agreement States have already established general license programs that may be outside the scope of any program developed by NRC. Requiring these States to change their programs may not be cost-effective and may actually decrease the level of confidence that the material is handled safely. At the other end of the spectrum, many Agreement States do little to regulate general licensees and do not maintain a listing of existing general licensees.
In lieu of having the States adopt compatible regulations, the review could determine whether NRC should reserve the right to issue distribution licenses.
The distribution license program would be comparable to the current program for issuing exempt distribution licenses. However, this would represent a large increase in NRC's workload.
- 2. COST A M FEE CONSIDERATIONS Under current Commission policy, fees are not charged to holders of general licenses under 10 CFR Part 31.5 because they are not required to file an application, do not receive a specific approval, are infrequently inspected, and there is no accurate listing of all general licensees. However, depending on the method chosen to improve control over generally licensed devices used 1
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- under 10 CFR 31.5, the current fee policy for these general licensees will
! need to be reconsidered.
- Innovative licensing alternatives other than the current specific and general
- licenses should be considered. For example, one possibility is a mail j registration system that requires licensees to answer a few questions i regarding possession and use of the devices. However, the major concern that i inhibited the implementation of the proposed inventory rule, published
- December 27, 1991, was the resources needed to follow up on devices that are
- initially unaccounted for. Even if registration were limited to a relatively
! small fraction of the 1.5 million existing generally licensed devices, and a few percent of those were unaccounted for, staff follow up might be needed for thousands of devices.
- 3. RADIATION EXPOSURE SAVINGS It is very difficult to ascertain the radiation exposure savings associated )
, with improvements to the licensing programs. At the present time, there is '
not enough information to determine the exposure to general licensees' i personnel or to the public during use of a device, or to determine exposures l l associated with unauthorized transfer or disposal of a device. !
1 i MRC issued a contract, in 1987, to Oak Ridge Associated Universities (0RAU) to
! determine the likelihood of improper transfer or disposal of generally licensed devices and the exposures associated with such transfer or disposal.
i i ORAU concluded, in part, that there is a potential for significant doses from '
i several types of generally licensed devices. However, the NRC staff did not
- agree with this conclusion. The staff believed the conclusions were based on-unrealistic assumptions that produce dose estimates that are too conservative.
- Based on a Commission suggestion in 1991, the staff procured the services of
! another contractor, Pacific Northwest Laboratories (PNL), to perform a peer j review of the ORAU study.
1 i PNL's conclusion is that it did not have enough information available, due to l time and resource constraints of the contract, to accurately determine the l dose committments expected as the result of an accident involving a generally
- licensed device or of improper transfer or disposal of such device, or to e accurately predict the likelihood of an accident or improper transfer or
! disposal actually occurring. However, PNL has concluded that the results of l the ORAU study are extremely conservative and present a much higher dose
- commitment than would be expected.
! 4. DEVICE DESIGN l The staff has been assessing whether certain generally licensed devices are
- safe for use under the current licensing program. Generally licensed devices
- are currently designed to meet the criteria in 10 CFR 32.51. These criteria j account for both ordinary and accidental use, handling, and storage conditions. Requirements for normal use of the device were developed to make
- it unlikely that any person could receive an annual dose in excess of 5 mSv (500 mres). Because of the design and intended use of generally licensed devices, the only persons likely to receive a dose close to this limit during 2
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I j normal use would be employees of a general licensee. While NRC has always
. considered the employees occupational workers, a question should be posed as
, to whether these employees should be considered members of the public or a special class of occupational worker.
- J j The Office of Nuclear Regulatory Research is continuing to assess the design i dose criteria established for generally licensed devices in 10 CFR Part 32, to
- determine if the limit should be lowered from 10 percent of the occupational j limit in 10 CFR Part 20, 5 mSv/yr (500 mres/yr),.to the dose limit for members i of the public, 1 mSv/yr (100 mres/yr). Changing the criteria to 1 mSv/yr i 2 (100 ares /yr) would mean all devices designed to meet the 5 mSv/yr l (500 ares /yr) criteria would need to be redesigned or used under a specific j license.
l One approach might be restricting devices to use only under a specific j license. However, this must be evaluated with caution, since the only ,
- limiting regulation on exposures would be the Part 20 occupational dose limit, !
t 50 mSv/yr (5 res/yr). If all users of these devices were specific licensees, l j the manufacturers of the devices would have no incentive to design devices j that would meet the more stringent criteria included in 10 CFR 32.51. Thus,
< additional requirements would need to be added to the rules or as specific l i, license conditions.
t j 5. CHANGES THAT AFFECT ALL DEVICES VERSUS ONLY NEWLY. ACQUIRED DEVICES u
! Changes to the general and specific licensing programs would need to address >l both existing and future licensees. If a plan is developed that only i l addresses future licensees, its effects will not be seen for some time, since l current licensees could continue to possess byproduct material, under current i j licensing requirements, for many years. j i '
- Any program implemented that would impose new requirements on existing
! licensees would need to address communicating with all existing licensees, to !
i verify the information currently on file with the Commission and to verify j that the licensee has made the appropriate changes to ensure compliance with j any new requirements.
- 6. DEVICE DISPOSAL l Any program that is implemented needs to address options for disposal of unwanted devices. Many existing licensees may have unwanted devices but either cannot afford disposal of the devices, or cannot locate a person authorized to receive the device for disposal. Disposal may be denis.-d because ;
I the licensee is not a member of a low-level waste di.sposal compact or because the devices contain greater than Class C material, for which there is no l disposa; repository.
l I_ The Department of Energy (DOE) has indicated that it will accept material for
- i. disposal if it poses a threat to public health and safety and there is no l
other means of disposing of the material. However, DOE does not consider the t
inability to pay for disposal as such a threat.
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- 7. DEVICE IDENTIFICATION
" Dne item of concern after unauthorized transfer or disposal has occurred is identification of the device and byproduct material. Currently, generally licensed devices are required to have a "... durable, legible, clearly visible label...." However, many of the devices that have been improperly transferred-
- or disposed of either did not have a label or had an illegible label.
i j A method to solve this problem would be to require that device labels be
) designed to withstand the harsher, unexpected environments that may occur with improper transfer / disposal. This would include engraving the required
- j. information into the source housing. In addition, the regulations could include a requirement to have the distributors engrave the name of the ,
licensee using the device on the label. This would allow tracking the device i J to the person who improperly' transferred or disposed of it. However, none of these changes would ensure identification of a device if it were intentionally !
disposed of by an unauthorized method.
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