ML20210K065
| ML20210K065 | |
| Person / Time | |
|---|---|
| Issue date: | 07/29/1999 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Flater D IOWA, STATE OF |
| References | |
| GL-99-01, NUDOCS 9908050203 | |
| Download: ML20210K065 (5) | |
Text
k . .- .. l Mr. Donald A. Flater, Chief 8 088 Bureau of Radiological Health
- l. 'lowa Department of Public Health
(' Lucas State Office Building Des Moines,IA 50319-
Dear Mr. Flater:
Thank you for your' May 24,1999 letter, regarding the bundling of exempt quantities of
' byproduct material in gauging devices.
Section 30.18 of 10 CFR is assigned compatibility category B, which requires adoption of an l Agreement State equivalent requirement that is essentially identical. The modification to your
- regulation results in a rule that is not essentially identical in wording to the NRC's regulation.
~ However, we recognize that yo6r rule modification to' eliminate the ability to " bundle" exempt quantities of exempt sources under your equivalent to 10 CFR 30.18 is consistent with the
- . guidance provided in NRC Generic Letter 99-01, which clarified that 10 CFR 30.18 does not l authorize bundling of exempt quantities. Therefore,"until NRC reaches final resolution of this issue, either by rule change, or other regulatory action, we do not believe your rule modification presents a significant programmatic compatibility difference.
.' Thank you for bringing this matter to our attention.
Sincerely, ,
% Signed By::
, PAULH. LOHAUS :
Pnul H. Lohaus, Director
' Office of State Programs
' Distribution:
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Mr. Donald A. Flater, Chief Bureau of Radiological Health lowa Department of Public Health Lucas State Office Building l Des Moines,IA 50319 l
Dear Mr. Flater:
Thank you for your May 24,1999 letter, regarding the bundling of exempt quantities of i byproduct material in gauging devices.
Section 30.18 of 10 CFR is assigned compatibility category B, which requires adoption of an Agreement State equivalent requirement that is essentially identical. The modification to your regulation results in a rule that is not essentially identical in wording to the NRC's regulation. .
However, we recognize that your rule modification to eliminate the ability to " bundle" exempt l quantitles of exempt sources under your equivalent to 10 CFR 30.18 is consistent with the guidance provided in NRC Generic Letter 99-01, which clarified that 10 CFR 30.18 does not authorize bundling of exempt quantities. Therefore, until NRC reaches final resolution of this issue, either by rule change, or other regulatory action, we do not believe your rule modification presents a significant programmatic compatibility difference.
Thank you for bringing this matter to our attention. I n rely,<
1
. t c Paul H. Lohaus, Director w '
Office of State Programs -
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Mr. Donald A. Flater, Chief '
Bureau of Radiological Health lowa Department of Public Health Lucas State Office Building Des Moines,IA 50319
Dear Mr. Flater:
Thank you for your May 24,1999 letter, regarding the b Jndling of exempt quantities of byproduct material in gauging devices.
Our previously stated position on this issue has not changed. We believe that based on the compatibility category B assigned to 10 CFR 30.18, your equivalent requirement should be worded essentially identical. However, any decision to modify your rule at this time, or at a later time following completion of NRC activities to address Ihis issue is solely a State decision. The status of your rule will be covered during the next regularly scheduled Integrated Materials Performance Evaluation Program (IMPEP) review.
Thank you for bringing this matter to our attention.
Sincerely ,
Paul H. Lohaus, Director Office of State Programs Distribution:
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DATE 07Ff/99 07/23/99
- 07/2if/99 07/1 /99 i l
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INSERT IN LIEU OF 2ND PARAGRAPH: .
m II 10 CFR 30.18 itas assigned compatiblity category B, which nomut!!y requires adoption of an Agreement State equivalent requirement that is essentially identical. The modification to your up
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- .; r ' '^ ^r9 ??.1S results in a rule that is not essentially identical in wording to the NRC's regulation. However, we recognize that your rule modification to eliminate the ability to
" bundle" exempt quantities of exempt sources under your equivalent to 10 CFR 30.18 is '
consistent with the guidance provided in NRC Generic Letter 99-01, which clarified that 10 CFR 30.18 does not authorize bundling ofM:
exempt quantities. Therefore, M: " . ;; Leiivvu ino. :he
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Mr. Donald A. Flater, Chief Bureau of Radiological Health lowa Department of Public Health ~
Lucas State. Office Building Des Moines,IA 50319
Dear Mr. Flater:
Thank you for your May 24,1999 letter, regarding the bundlin of exempt quantities of byproduct material in gauging devices.
Our previously stated position on this issue has not change We believe that based on the compatibility category B assigned to 10 CFR 30.18, your eq ivalent requirement should be worded essentially identical. However, any decision to m your rule at this time, or at a later
. time following completion of NRC activities to address this ' sue is solely a State decision. The j status of your rule will be covered during the next regularly scheduled Integrated Materials Performance Evakiation Program (IMPEP) review.
Thank you for bringing this matter to our attention.
Sincerely, Paul H. L haus, Director Office of tate Programs l
Distribution- j DIR RF - DCD (SP 7)
SDroggitis PDR (YE /)
JLynch, RSAO, Rill lowa File DOCUMENT NAME: G:\ LAB \ BUNDLING.WPD Ta receive e cop r of this document, Indicate in the box: 'C's Copy without attachmenV huve "E* = Copy with venclosure *N's No copy OFFICE OJE/[4 NMSS:D l OGQ l OSP Q l l l UAME- LABohiffg:(ftf CJPaperiello WW SATreby PHLohn uis '
DATE 07/T/99 07tD/997 07// /99 07/'l/99 i/ OSP FILE CODE: SP AG 9 F
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, I _PL THOMAS J.VILS bK '
DEPARTMENT OF PUBLIC HEALTH GOVERNOR STEPHEN C. GLEASON, D.o., DIRECTOR SALLY J. PEDERSON LT. GOVERNOR May 24,1999 Paul Lohaus, Director Office of State Programs US Nuclear Regulatory Commission Mail Stop 3-D-23 Washington, DC 20555
Dear Mr. Lohaus:
l This correspondence refers to NRC Generic Letter 99-01 and telephone conversations between my staff and yours. The generic letter discussed the licensing exemptions provided by 10 CFR 30.18 and the relationship of these exemptions to certain items that contain " bundles" of exempt quantities in certain gauging devices. As a summary the letter states:
NRC does not authorize: (a) the bundling of exempt quantities of byproduct material; (b) any program advising persons to combine exempt quantity sources; and (c) the .
possession and use of bundled exempt sources, in unregistered devices, by persons I exempt from licensing.
The letter concludes by stating that the NRC still has this situation under review and that, after the evaluation, NRC "will consider appropriate steps, including rulemaking..." to resolve it.
In April 1998, we changed our administrative rules to tighten the exemption contained in our counterpart of 30.18. We, by rule, eliminated the ability to " bundle" exempt quantities of exempt sources in devices. We did this even though Mr. Richard Bangart, the former Director of the Office of State Programs, implied in a letter to us dated November 27,1997, that we would incur a finding of"NOT Compatible
- during our next IMPEP rieview. Our response is contained in my letter to Mr. Bangart dated March 13, 1998.
Since regulatory oversight ends with the end user, the response to Mr. Bangart's letter indicated that our view of bundling exempt sources was a matter of health and safety.
i We stated our position in a letter to the radiation safety officer of BSI Instruments in i September 1997-I have enclosed a copy of that letter. Although not similar to any of the scenarios we presented in that letter, we have had, as a matter of record, an incident, which could have resulted in exposures, possibly execeding regulatory limits, involving a failure of a device with bundled exempt sources.
LUCAS STATE OFFICE BUILDING / 321 E.12TH ST. / DES MOINES, IOWA 50319-0075 DEAF RELAY (HEARING OR SPEECH IMPAIRED) 1-800-735 2942 / INTE RN ET: H TT P ://I D P H. STAT E.l A.U S/
FAuiLY & Couu. HEALTH HEALTH PROTECTION PLANNING & ADMINISTRATION SUBSTANCE ABUSE & HEALTH PROuCTION DIRECTOR's OFFICE 515-281 3931 515-281-5643 515-281-5787 515-281-3641 515-281 5604 FAX /515-242-6384 fax /515-281-4529 F Ax/515-281-4958 fax /515-281-4535 fax /515/281-4958 g ,
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- Page 2
( Lohaus, Paul US NRC l
May 27,1999 This incident involved a gauging device manufactured and distributed by Ronan Engineering Company and is _ documented by Event Report ID No: IA-99-01. The
' device contained nine bundles of ten exempt sources.
I
! In telephone conversations between my staff and yours, we have been asked if we would l change our rules back to the version that was verbatim with 30.18. We will not do so, even considering the compatibility issues for two reasons:
- 1. In light of the incident we had, our health and safety concerns still exist.
, - 2. Generic Letter 99-01 indicates that NRC has not published a final resolution to this problem and may even change 30.18. If this happens we would have to change our rules again.
. Until NRC publishes its ' final' position we consider this matter closed and will take no further action.
' If you have any questions or comments, please contact Dan McGhee at (515) 2817007 or me.
incerely,
/ .
nald A. Flater, Chief WL
. Bureau of Radiological Health (515) 281-3478 cc: Lloyd Bolling Jim Lynch Enclosure
~ 19.nWclenmunlechange. doc I'
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. *?i' STATE OF I A TERRY E. BRANSTA GOVERNOR DEPARTMENT OF PUBLIC HEALTH CHRISTOPHER G. ATCHISON. DIRECTOR September 24,1997 Mary Dedola Radiation Safety Officer BSIInstruments 101 Corporation Drive Aliquippa,PA 15001
DearMs. Dedola:
This responds to your letter dated September 3,1997, and documents our telephone conversation of September 18, 1997. The subject of these communications was your company's " Photon Gauge" program. In your letter you announced your intent to distribute devices which would be loaded, by the end user, with a maximum of thirty discreet exempt radioactive sources containing Cs-137. In our conversation, I informed.
you that until we received more information and a safety evaluation is conducted on your devices, we will not allow distribution of these devices in Iowa.
We have asked the US Nuclear Regulatory Commission (NRC) for a legal interpretation of the intent of 10 CFR 30.15 and 30.18. We have, as an Agreement State, identical .
rules. However, our thoughts are that these exemptions were to remove the regulation from very small amounts of radioactive material to allow the manufacture and distribution of items such as illuminated locks, smoke detectors, micro balances and the like. Collocating a number of these exempt sources in one device defeats our pnmary purpose which is to limit dose to the general public.
l While your devices may pose no threat to workers in establishments that use the gauges, we must take the long view and ask, "What are the effects of this radioactive material in l the public domain?" Our greatest concem in this regard is the waste stream.
l There are well documented cases in which manufacturers have introduced radioactive cobalt and cesium into their products. The sources in question were licensed, yet found their way to foundries and fabrication plants. Contaminated fencing and table legs were readily available.
l 1
LUCAS STATE OFFICE BUILDING / DES MotNES. lOWA 503194075 / 515-281-5787 FAX # (515) 281-4958 / TDD-DEAF SERVICES *(515) 242-6156
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Page 2 l Dedola, Mary BSIInstmments September 24,1997 l:
Exempt sources have an even higher probability of entering the waste stream from manufa+dng pmcesses since there is no regulation of their disposal. It is conceivable that one of your products containing 300 Ci of Cs-137 could get to a scrap yard and be.
incorporated into some commercially available, home-use prodact. 1 1
We have calculated that an unshielded 300 Ci of Cs-137 produces a dose ate of 1.1 mrem /hr' @ 30cm from a point. source. Let us assume that 10% of this a-tivity is incorporated into a bracket supporting a bed frame. Using the generally accepted eight hours of sleep per night, an individual using that bed would receive a dose of approximately 320 mrem in a year. Depending upon which agency one looks to for dose limits to the general public and environmental standards, this exposure is any where from 6x-64x a limit. I I
We consider this a serious problem. _ Uncontrolled disposal of exempt sources could cause such exposures. We feel so strongly about this issue that we are considering a rule change to speci5cally prohibit accumulations of exempt sources in individual devices.
I stand by the statements I made to you on the telephone, and I have described my j motivation. If you have any questions or comments, contact me or Dan McGhee at 515-281-7007.
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D nald A.Flater, Chief Bureau ofRadiological Health (515) 281-3478 a.mu.a.u ' '