ML23151A554
| ML23151A554 | |
| Person / Time | |
|---|---|
| Issue date: | 12/31/1985 |
| From: | Stello V NRC/EDO |
| To: | |
| References | |
| PRM-040-025, 50FR53335 | |
| Download: ML23151A554 (1) | |
Text
DOCUMENT DATE:
TITLE:
CASE
REFERENCE:
KEYWORD:
/
12/31/1985 PRM:040-025 - 50FR53335 - ST ATE OF ALABAMA
)
PRM-040-025 50FR53335 RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete
STATUS OP RULEMAXING PROPOSED RULE:
PRM-040-025 OPEN ITEM (Y/N) N RULE NAME:
STATE OP ALABAMA PROPOSED RULE PED REG CITE:
50FR53335 PROPOSED RULB PUBLICATION DATE:
12/31/85 HUMBER OP COMMENTS:
1 ORIGINAL DATB POR COMMENTS&
I I
EXTENSION DATE:
I I
~
r PINAL ROLE~PBD. REG. CITE: 53:B'R.10252 FINAL RULE PUBLICATION DATE: 03/31/88 NOTES ON VOLUME 1 (8/26/85 -
3/3/86). PETITION WITHDRAWN 53 FR 10252.
TATUS FILE LOCATED ON Pl.
P RULE TO FIND TBB STAFF CONTACT OR VIEW THE RULEMAKING HISTORY PRESS PAGE DOWB KEY HISTORY OP THE RULE PART AFFECTED: PRM-040-025 RULB TITLES
,tf:-fr-<"'r' ROPOSED RULE SECY PAPER:
PINAL RULE SECY PAPER:
CONTACTl:
CONTACT2:
STATE OP ALABAMA PROPOSED RULB SRM DATE:
FINAL RULE SRM DATE:
STAFF CONTACTS DATB PROPOSED RULE I
I SIGNED BY SECRETARY:
DATE FINAL RULE I
I SIGNED BY SECRETARY:
ON THE RULE KAIL STOP:
PHONE:
MAJ:L STOP:
PHONE:
12/26/85 03/17/88
DOCKET NO. PRM-040-025 (50FR53335)
DATE DOCKETED 09/03/85 12/26/85 03/03/86 03/17/88 DATE OF TITLE OR In the Matter of STATE OF ALABAMA DOCUMENT DESCRIPTION OF DOCUMENT 08/26/85 PETITION OF THE STATE OF ALABAMA TO MODIFY 10 CFR PART 40.
12/26/85 FEDERAL REGISTER NOTICE - RECEIPT OF PETITION FOR RULEMAK.ING 03/03/86 COMMENT OF NORTH AMERICAN PHILIPS LIGHTING CORP.
(RICHARD A. MESERVE) (
- r,*
DOCl"ET NUMBER ITj('~ r U' r PRM 4t1'-..t!)-
C.StJ Pfocfr.i! 3 ~
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U',NRC "88 MAR 17 P 4 :11 OFFILF Jr : : l,~ :-. f,-.. 11 r OOCK[T!Nt,,,. '.)Li<VlU.
BRANCl-i NUCLEAR REGULATORY COMMISSION 10 CFR PART 40
[DOCKET NO. PRM-40-25]
The State of Alabama; Withdrawal of Petition for Rulemaking AGENCY:
Nuclear Regulatory Con111ission.
ACiatr:
Petition for rulemaking; withdrawal.
SUMMARY
The Con111ission is withdrawing, at the petitioner's request, a petition for rulemaking that was filed by the State of Alabama.
In the petition, dated August 26, 1985, the State of Alabama had requested that the Con111ission review the exemption from licensing requirements for products or parts containing tungsten or magnesium-thorium alloys whose thorium content does not exceed 4% by weight, and either remove the prohibition on processing the parts or set out the prohibition as part of a general license.
ADDRESSEES:
Copies of the petitioner's letters of request and withdrawal are available for public inspection in the Co11111ission's Public Document Room.
1717 H Street, N.W., Washington, D.C.
Single copies of these letters may be obtained by writing to the Division of Rules and Records, Office of Administration and Resources Management, U.S.Nuclear Regulatory Commission, Washington, D.C. 20555.
FOR FURTHER INFORMATION CONTACT:
Sterling W. Bell, Division of Industrial and Medical Nuclear Safety, U.S. Nuclear Regulatory Co111T11ssion, Washington,
- J D.C. 20555, Telephone: 301-492-0617.
SUPPLEMENTARY INFORMATION:
Section 40.13(c){4) of 10 CFR Part 40, *Domestic L1censing of Source Material," provides an exemption from licensing requirements for any person who possesses finished products or parts containing tungsten or magnesium-thorium alloys up to 4% thorium by weight. However, the exemption does not authorize chemical, physical, or metallurgical treatment or processing of the products. Therefore, an unlicensed person may possess and use the products as long as the person does not treat or process them.
On August 26, 1985, the State of Alabama, Department of Public Health, submitted a petition for rulemaking which requested NRC to review the exemption and make certain amendments to its regulations. A notice of receipt of the petition was published in the Federal Register on December 31, 1985 (50 FR 53335).
Public comments were requested by March 3, 1986.
2
The petitioner stated the prohibition on treatment and processing of the products containing thorium is unenforceable for unlicensed persons.
The State of Alabama said that it had identified thorium products in scrap which were being melted or cut by unlicensed persons.
The petitioner requested that NRC review the restriction on processing, and delete the restriction if it is unnecessary to protect the public health and safety. The petitioner believed that the restriction was necessary and, therefore, recommended that the exemption be deleted and replaced by a general license.
The general license would be similar to the existing general license provided in 10 CFR 40.25,
- General license for use of certain industrial products or devices.u The petitioner requested that the general license require that the product be obtained from a licensed manufacturer, be labeled, and be authorized for distribution only if the manufacturer demonstrates that its use will not result in radiation doses to persons above certain specified limits.
Only one conunent was received on the petition. Covington and Burling, Counsel for North American Philips Lighting Corporation, opposed the petition on the basis that the petition did not demonstrate any significant health risks resulting from the current regulatory approach, or demonstrate that any health and safety benefit would result which would justify imposing additional regulatory burden on licensees.
3
After reviewing the original reasons for the petition and the availability of sufficient supporting data at this time, the petitioner believes that the best approach 1s to have the requested changes retained by the NRC staff for 1ts considerations when the NRC next considers general revision to this portion of its regulations. Therefore, by letter dated January 15, 1988, the petitioner requested that the petition be withdrawn.
The NRC concurs with the State of Alabama.
The NRC staff believes that 10 CFR Part 40, including the exemption questioned by the petition, provides adequate protection of the public health and safety. However, the NRC staff also believes that, in light of the many exemptions which currently exist in Part 40, a general revision of that portion of the regulations would provide consistency and clarity to the regulatory framework.
The NRC accepts the State of Alabama's request that the petition be withdrawn.
Dated at Bethesda, Maryland, this ~ay of March 1988.
For The Nuclear Regulatory COll1llfss1on.
Executive Director for Operations.
4
DOCKET NUMt:Rt<
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P.ETITION RULE PRM,4J-,tS-Co v ING TON
& suRLING {_5~F!(.oa~35)
DANIEL M, GRIBBON OON V, HARRIS,,JR, W ILLIAM STANLEY., JR, WEAVER W. OUNNAN EDWI N M, ZIMME RMAN JEROME ACKERMAN HENRY P, SAILER JOHN H, SCHAFER ALFRED H, MOSES JOHN Lc:MOYNE ELLICOTT DAVIDE, McGIFFERT H, EDWARD DUNKELBERGER,JR, BRICE McADOO CLAGETT RIC MARO A, BRADY HERBERT OYM JOHN VANOERSTAR NEWMAN T, HALVORSON,JR, HARVEY M. APPLEBAUM MICHAELS, HORNE CHARLES F. C. R UFF M ICHAEL BOUDIN BINGHAM B, LEVERICH ALLAN TOPOL VIRG INIA G. WATKIN RICHAR D 0, CO PAK EN CHARLES LISTER PETER O. TROOBOFF
~5~~~yo~*e~~i~AtS,JR.
WILLIAM O, IVER SON
~A=~~,~~... ~~'o~6TON, JR, COLEMAN S, HICKS STUART C. STOCK EUGENE 0, GU LLANO
~U1c0NMtl~~~6':?J1 JR.
PATRICIA A, BAR ALO REEVES C, WESTBROOK THEODORE VOORHEES, JR,
.JEFFREY G, HUVELLE JOANNE a. GROSSMAN J. MICHAEL HEMMER GREGORY M. SCHMIOT J, MARK IWRY BERT.J. GAGE VID E. ROACH ll BY HAND STANLEY L, TEMKO JAMES C, McKAY JOHN W, DOUGLAS HAMILTON CAROTHERS J, RANDOLPH WILSON R09 £RTS B. OWEN EDGAR F. CZARRA,J R.
WILLIAM H, ALLEN DAVID B. ISBELL JOHN 8,JONES,JR.
PAUL R. DUK£ PHILIP R,STANSBURY CHARLES A.MILLER PETER BARTON HUTT EUGENE I. LAMBERT MARK A, WEISS HARRIS WEI NSTEIN JOHN B, OENNISTON PETER J. NICKLES JONATHAN 0, BLAKE
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£, EDWARD BRUCE DAVID N, BROWN PAUL J, TAGL1ABUE ANDREW W, SINGER DAVID H, HICKMAN RUSSELL H, CARPENTER,JR, NICHOLAS W, F"ELS THEODORE Lo GARRETT DANA T, ACKERLY JOHN M, VINE JOHN TH O MAS SMITH ll JOHN P, R UPP CLAUSEN ELY, JR.
RICHARD F. KINGHAM ROBERT M, SUSSMAN MICHAEL R, LEVY
'?~8:...°sEs~W~CL11~t/si*N, JR.
PAUL J, BERMAN WILLIAM P, SKINNER GE.ORGE M, CHESTER,JR.
RICHARD A, MESERVE GREGG H, LEVY CAROLYN F, CORWIN OSCAR M. GARIBALDI 1201 PENNSYLVANIA AVENUE, N. W.
P. 0. BOX 7S66 WAWt.'WfTel'JI, o. c. 20044 USNRC -
c202J 662-6000 WRITER'S DIRECT DIAL NUMBER 086 HAR -3
OCKETING w>,
- BRA N,,,
I P4 :OJ 662-5304 March 3, 1986 Mr. Samuel J.
Office of the United States Chilk, Secretary Commission Nuclear Regulatory Commission 1717 H Street, N. W.
Washington, D. C.
20555 Re :
Dear Secretary Chilk:
State of Alabama's Petition for Rulemaking, Dkt No. PRM-40-25 FONTAINE C, BRADLEY EDWARD BURLING, JR, HOWARD C, WESTWOOD CHARLES A. HORSKY JOHN T, SAPIENZA
.JAMES H. McGLOTHLI N ERNEST W,JENNES HARRY L. SHN IOERMAN EDWIN S~ COHEN COUNSEL JOHN SHERMAN COOPER DON A. Z f MMERMAN 01" COUNSEL TWX: 710 8Z2*0005 (ca WSM)
TELEX: 89*.593 (COVLING WSH)
TELECOPIER I NFORMATION:
(ZOZ) 882*8280 CABLE1 COVLING I am writing on behalf of North American Philips Lighting Corporation concerning a petition for rulemaking that was submitted by the State of Alabama.
The State requests that the NRC modify the current exemption from licensing requirements for certain products or parts containing not more than 4 percent thorium by weight.
The NRC has requested comments on the State's proposal.
50 Fed. Reg. 53335 (Dec. 31, 1985).
The current NRC regulations contain an exemption from licensing for:
Any finished product or part fabricated of, or containing tungsten or magnesium-thorium alloys, provided that the thorium c<\\ntent of the alloy does not exceed 4 percent ~y weight and that the exemption contained in th's subparagraph shall not be deemed to authorize the chemical, physical or metallugical treatment or processing of any such product or part.
COVI N GT O N o. BURLI N G Mr. Samuel T. Chilk March 3, 1986 Page 2 10 CFR 40.13(c) (4).
The State asserts that products or parts currently covered by the exemption should instead be subject to a general license.
The State suggests specific modifications of the NRC rules that impose significant new restraints on the manufacture, transfer, and possession of such products or parts.
The unspoken premise of the State's petition is that health risks are created as a result of a general absence of awareness of the limitation on treatment or processing, and that these risks would be avoided if the materials were subject to a general license.
But there is no evidence, beyond one isolated incident described by the State, to indicate either that those who handle materials covered by the exemption are generally unaware of the limitation on treatment or processing, or that any significant health risks result from the current regulatory approach.
Absent evidence on these matters, wholesale modifica-tion of the licensing regime is inappropriate.
The specific changes proposed by the State also go further than is necessary to address the concerns that motivate the petition.
For example, the State would impose detailed labeling requirements that go beyond a notice barring treatment or processing.
It would require com licated predictions of exposure under accident circumstances.
It would also impose severe restraints on the transfer of products and parts; transfer to another general licensee would be authorized only when the product or part remains in use "at the same location," or when the product or part is held in storage "in the original shipping container at its intended location of use."
Most of the proposed requirements are unrelated to unauthorized treatment or processing, and none are justified by any analysis of risk.
Moreover, the modifications would impose significant burdens on the NRC and those who manufacture or transfer products or parts containing not more than 4 percent thorium.
Thus, even if the NRC were to conclude that an examination of the exemption is appropriate, the modifications proposed by the State should be rejected.
cc:
J. Dutton Richard A.
eserve Counsel for North American Philips Lighting Corporation
DOCKET NUMBER P.ETITION RULE PRM ~ot.5
{5JF!l S333?)
NUCLEAR REGULATORY COMMISSION 10 CFR PART 40 Docket No. PRM~40-25 "85 State of Alabama:
Receipt of a Petition for Rulema AGENCY:
Nuclear Regulatory Corrvniss ion.
ACTION:
Petition for rulemaking.
7590-01
SUMMARY
The Nuclear Regulatory Corrvnission is publishing for public co1m1ent
- a notice of receipt of a petition for ru lemaking submitted by the State of Alabama *. The petition requests that the NRC amend its -regulations governing unimportant quantities of source material. The petitioner suggests that the NRC examine the exemption from licensing requirements for products or parts fabricated of or containing tungsten or magnesium-thorium alloys whose thorium content is less than 4 percent by wei~ht and either remove the restriction on this exemption or set out the restriction as part of a general license.
The petitioner requests this action so that a person who obtains an exempt product covered by the exemption would be aware of limitations placed on its use.
DATE: Submit comnents by MAR 3 1985
- Co1m1ents received after this date will be considered if it is practica l to do so, but assurance of consideration cannot be given except as to comments received on or before this date.
ADDRESSES:
Submit corrvnents to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, A_ttention: Correspondence and Records Branch.
. For a copy of the petition write:
Division of Rules and Records, Office of Administration, U.S. Nuclear Regulatory Co1T111ission, Washington, DC 20555.
rnspect and copy the petition or coirrnents received on the petition at:
The NRC Public Document Room, 1717 H Street, NW, Washington, DC.
FOR FURTHER INFORMATION CONTACT:
John Philips, Chief; Rules and Procedures Branch, Division of Rules and Records, Office of Administration, U.S. Nuclear Regulatory Co1T111ission, Washington, DC 20555, Telephone:
{301} 492-7086 or Toll Free (800) 368-5642.
SUPPLEMENTARY INFORMATION:
The Nuclear Regula~ory Corranission has received a petition for rulemaking from the State of Alabama.
Thi$ petition for rulemaking has been assigned Docket No. PRM-40-25.
The petitioner requests that the NRC amend its regulations governing unimportant quantities of source material.
Section 40.13(c)(4) sets out an exemption from licensing requirements for any person who receives, possesses, uses, or transfers a product or part fabricated of, or containing tungsten or magnesium - thorium alloys if the thorium content of the alloy does not exceed four percent by weight. This provision also restricts the exemption by not authorizing the chemical, physical, or metallurgical treatment or processing of the exempt product.
The petitioner believes that in pla,cing a restriction on an exemption, the NRC has created a structurally deficient regulation that may lead to unintentional violations by persons who may receive products covered by the exemption and be
- unaware of any.further regulatory restriction. The petitioner identified a situation where materials were distributed under this exemption in scrap
_ metals which were melted and cut by an oxyacetylene torcn.
To remedy this situation, the petitioner suggests that a safety evaluation be perfonned to determine whether or not this restriction is necessary.
ff the safety evaluation does not indicate that the restriction is needed, the petitioner believes it should be removed.
However, if the restriction is
- needed, for the use of four percent magnesium-thorium alloys, it should not be presented as part of an exemption, but should be included under a general license.
The petitioner believes the appropriate course of action is to place these products in the general license provisions of 10 CFR 40.25 and s~ggests the following amen~ents to the regulations to accomplish this action.
- 1.
In §40.25,,add a new paragraph (f) to read as follows:
§40.25 General license for use of certain industrial products or devices.
11 (f) A general license is hereby issued to receive, acquire, possess, and use any finished product or part fabricated of, or containing tungsten or magnesium-thorium alloys, provided that the thorium content of the a1loy does not exceed 4 *percent by weight and that the general license contained in this paragraph (f) shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part.
Any general licensee is authorized to transfer such product or part to another general l i.censee only:
- (1) when the product or part remains in use at the same location, or (2) where the product or part is held in storage in the original shipping container at its intended location of use prior to the initial use by a general licensee."
- 2.
In §40.34, paragraph (d) is added to read as follows:
§40.34 Special requirements for the issuance of a specific license.
11 (d) An app,lication for a specific license to manufacture or, initially transfer the -products or parts containing.,not more than 4 percent thorium to persons generally licensed under §40.25(f) of this Chapter or equivalent regulations of an Agreement State will be approved if:
(1) The applicant has satisfied* the general requirements of §40'.32 of this Chapter; (2)
T~e applicant submits sufficient information relating to the mao'ufacture, quality control, labels, proposed uses and potential hazards of the product or part to provide reasonable assurance that:
(i} Under ordinary condition of' handling, storage, and use the product or part the thorium contained in the product or part will not be released or inadvertently removed from the product or part and it is unlikely.that any person will receive in any period of one calendar quarter a dose in excess of 10 percent of the limits spe~ified in the table in §20.lOl(a} of this Chapter or if the exposure may be to radioactive materials in air in excess of 10 percent of the limits specified in §20.103(a} of this Chapter; and,
- (ii) Under accident condition such as fire and/or explosion associated with the handling, storage, and use of the product or part, it is unlikely that a person would receive an external radiation dose or an internal I
dose commitment in excess of the dose to the appropriate organ as specified in column IV of the Table in §32.24 of this Chapter *
( 3)
Each product or part bears or has an accompany.ing 1 abe l or instructions approved by the Corrunission which contain in a clearly identified and separate statement instructions and precautions necessary to assure safe installation, operation, servicing, and disposal of the product or part; (4)
Each person licensed under this section shall furnish a copy of the general license contained in §40.25(f) or an Agreement State's regulation equivalent to §40.25{f) to each person to whom he directly or through an intermediate person transfers thorium in a product or part.
Further, each person licensed under this section shall report the transfer of such product or parts i~
the manner required for generally licensed devices pursuant to
§32.52 of this Chapter."
- The NRC invites public comnent on PRM-40-25.
Those who intend to submit comments on the petition may obtain a copy of the petition from the Division of Rules and Records, Office of Administration, U.S. Nuclear Regulatory Corrmission, Washington, DC 20555.
Dated at Washington, DC this "Lf,f day of 1985.
r Regulatory Conmission
- Conmission.
State Office Building
- s5 IRA L. MYERS, M.D.
STATE HEALTH OFFICER Secretary Montgomery, Alabama 36130 August 26, 1985 U.S. Nuclear Regulatory Commission ATTN:
Chief, Docketing & Service Branch Washington, D.C.
20555 OFFICE o~ Sl,Jiit 1A1, '
DOCKETING " SERVIU BRANCH Re:
Dear Sir:
This is a petition for rule making filed pursuant to 10CFR2.802.
The State of Alabama, as an Agreement State, has identified an inconsistency within the reference section of 10CFR Part 40.
The last phrase of 40.13(c)(4) reading
" *** and that the exemption contained in this subparagraph shall not be deemed to authorize the chemical, physical, or metallurgical treatment or. processing of any such product or part; *** "
is a condition of use and since the user is exempt from 10CFR40.13 it is unenforceable.
The State of Alabama has identified certain mate.rials distributed pursuant to the provisions of this section in scrap metals.
These metals were being melted and were being cut up by an oxyacetylene torch.
It appears to us that if this restriction must be on the use of the 4 percent magnesium-thorium alloys then they should not be exempt but rather generally licensed under 10CFR40.25.
On the other hand, if the safety evaluation indicates that this restriction is unnecessary then it should be removed from the exemption in 40.13(c)(4).
Alabama believes that the proper course of action is to place these products in the general license section as 40.25(f).
"(f) A general license is hereby issued to receive, acquire, possess, and use any finish product o~ part fabricated of, or containing tungsten or magnesium~thorium alloys, provided that the thorium content of the alloy does not exceed 4 percent by weight and that the general license contained in this paragraph (f) shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part.
Any general licensee is authorized to transfer such product or part to another general licensee only
U_..
NU~LEAR REGULATORY COMMf~~~
DOCKETI 'G S:RVICE SECTION OFFICE C '."
'IE SECP..TA. Y OF THt
'.\\MISSION Po1tffl rk D le Copiu R Add'! c.
e Speclaf D", 1butiori
U.S. Nuclear Regulatory Connnission Page 2 August 26, 1985 (i) when the product or part remains in use at the same location, or (ii) where the product or part is held in storage in the original shipping container at its intended location of use prior to the initial use by a general licensee."
Further, 10CFR40.34 would have to be amended by adding a paragraph (d).
"(d) An application for a specific license to manufacture or initially transfer the products or parts containing not more than 4 percent thorium to persons generally licensed under 40.25(f) of this Chapter or equivalent regulations of an Agreement State will be approved if:
(1)
The applicant has satisfied the general requirements of 40.32 of this Chapter; (2)
The applicant submits sufficient information relating to the manufacture, quality control, labels, proposed uses and potential hazards of the product or part to provide reason-able assurance that:
(i) Under ordinary condition of handling, storage, and use the product or part the thorium contained in the product or part will not be released or inadvertently removed from the product or part and it is unlikely that any person will receive in any period of one calendar quar-ter a dose in excess of 10 percent of the limits specified in the table in Section 20.l0l(a) of this Chapter or if the exposure may be to radioactive materials in air in excess of 10 percent of the limits specified in Section 20.103(a) of this Chapter; and, (ii) Under accident condition such as fire and/or explosion associated with the handling, storage, and l"<Se of the product or part, it is unlikely that a person would receive an external radiation dose or an internal dose commitment in excess of the dose to the appropriate organ as specified in Column IV of the Table in Section 32.24 of this Chapter.
(3)
Each product or part bears or has an accompanying label or instructions approved by the Connnission which contain in a clearly identified and separate statement instructions and precautions necessary to assure safe installation, operation, servicing, and disposal of the product or part;
U.S. Nuclear Regulatory Commission Page 3 August 26, 1985 (4)
Each person licensed under this section shall furnish a copy of the general license contained in Section 40.25(f) or an Agreement State's regulation equivalent to Section 40.25(f) to each person to whom he directly or through an intermediate person transfers thorium in a product or part. Further, each person licensed under this section shall report the transfer of such product or parts in the manner required for generally licensed devices pursuant to Section 32.52 of this Chapter."
We appreciate your consideration of this request.
Thank you,
~:::t::
State Health Officer ILM:avg