Text

Forwards Notice of Pr 10CFR31, General Domestic Licenses for Byproduct Matl & 10CFR32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Matl, for Publication in Fr
	ML20217L035
Person / Time
Issue date:	06/01/1990
From:	Beckjord E; NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	Graham B, Sharp P, Udall M; HOUSE OF REP., ENERGY & COMMERCE, SENATE, ENVIRONMENT & PUBLIC WORKS
Shared Package
ML20217L002	List: ML20217K996; ML20217L007; ML20217L020; ML20217L029; ML20217L035; ML20217L044; ML20217L066; ML20217L759;
References
	FRN-56FR67011, RULE-PR-31, RULE-PR-32 AD34-1-051, AD34-1-51, NUDOCS 9708190018
	Download: ML20217L035 (73)
	v • d • e

___-

O IDENTICAL LETTFRS TO:

Chairman Bob Graham, Senate Subcommittee on Nuclear Regulation cc: Alan K. Simpson Chairman Philip R. Sharp, llouse Subcommittee on Energy and Power cc: Carlos J. Moorhead The lionorable Horris K. Udall, Chairman Subcommittee on Energy and the Environment Comittee on Interior and Insular Affairs United States llouse of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the information of the subcommittee is a copy of a Notice of Proposed Ruleqking to be publisheri in the Federal Register. 10 CFR Part 31 establishes general licenses for the possession and use of byproduct material contained in certain devices. The NRC is pro >osing to amend these regulations to require the general licensees to provide tie NRC with specific information about the licensed devices. Corresponding changes would also be made in 10 CFR Part 32 on the transfer reporting requirements imposed on persons authorized to distribute byproduct material. These changes are being made because there is inadequate accounting for generally licensed devices, and also a general lack of awareness of the appropriate regulations on the part of general licensees.

It is anticipated that the proposed rules will ensure that these two problems are remedied by more timely contact between the general licensee and the NRC.

Sincerely, 9700190010 970012 PDR PR 31 56FR67011 PDR Eric S. Beckjord, Director Office of Nuclear Regulatory Research

Enclosure:

Notice of Proposed Rulemaking cc: . Representative James V. Hansen

See previous copy for concurrence.

OfflCE:RDB:DRA:* RDB:DRA* RDB:DRA* DD:DRA* D:DRA* D:R a NAME: JMate MFleishman SBahadur FCostanzi BMorris temes EBecLjord DATE: 5/23/90 5/23/90 5/30/90 5/30/90 5/30/90 $ /90 6// /90 OfflCE: EDO OCA HAME: JTaylor DRathbun DATE 5/ /90 / /90 G)p{Cg Q, g OfflCIAL RECORD COPY

umTro sTAtts

(('p**teg*% ,

, NUCLEAR REGULATORY COMMISSION t, p! wasmuotou. o. c. rouss '

, \,e.../ ,

i i

Tha Honorable Philip R. Sharp, Chairman .. .. .

Subcomittee on Energy and Power l Comittee on Energy and Comerce United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the information of the subcomittee is a copy of a Notice of !

Proposed Rulemaking to be published in the federal Register. 10 CFR Part 31 establishes general licenses for the possession and use of byproduct material contained in certain devices. The NRC is pro)osing to amend these regulations to require the general licensees to provide t1e NRC with specific information ,

about the licensed devices. Corresponding changes would also be made in 10 CFR Part 32 on the transfer reporting requirements imposed on persons authorized to distribute byproduct material. These changes are being made because there is inadequate accounting for generally licensed devices, and also a general lack ofawarenessq(theappropriateregulationsonthepartofgenerallicensees.

It is anticipated that the proposed rules will ensure that these two problems are remedied by more timely contact between the general licensee and the NRC.

Sincerely, S.

Eric S. Beckjor W

jDirector Office of Nucle Regulatory Research Enclosuret Notice of Proposed Rulemaking

-cc: Representative Carlos J. Moorhead 1

i w

i

,, ,---.,--~,m.

. .~ v ,-s . . _ . . . - - _ , _ , --,.--,--% . , _y-.. . . , . - . .

p ** *

o d v9'o, UNITED S1 ATEs n NUCLE AR REGULATORY COMMISSION f8 ' '% <E 8

W A$HING T ON, D, C. 70555 3 . .u....

y The Honorable Bob Graham, Chairman -

Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510

Dear Mr. Chairman:

Enclosed for the information of the subcommittee ir, a copy of a Notice of Proposed Rulemaking to be published in the Federal Register. 10 CFR Part 31 establishes general licenses for the possession and use of byproduct exiterial contained in certain devices. The NRC is pro)osing to amend these regulations to require the general licensees to provide tle NRC with specific information about the licensed devices. Corresponding changes would also be made in 10 CFR Part 32 on the transfer reporting requirements imposed on persons authorized to distribute byproduct material. These changes are being made because there is inadequate accounting for generally licensed devices, and also a general lack of awareness gf the appropriate regulations on the part of general licensees.

It is anticipated that the proposed rules will ensure that these two problems are remedied by more timely contact between the general licensee and the NRC.

Sincerely, O q <? s I d J. J %

Eric S. Beckjord 1 rector Office of Nuclear egulatory Research

Enclosure:

Notice of Proposed Rulemaking cc: Senator Alan K. Simpson

. v

+#p* N o ,o UNITLD STATES

/7' On NUCLEAll flEGUL ATOi1Y COMMISSION

$ I WWHNG T ON, D. C, 705%

%, . . . . . /

The lionorable Horris K. 'Udall, Ch' airman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs United States llouse of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosedfortheinformationofthetubcommitteeisacopyofaffoticeof proposed Rulemakir.g to be published in the Federal Rg ister. 10 CFR part 31 establishes general licenses for the possession and use oT byproduct material contained in certain devict.s. The NRC is pro)osing to amend these regulations to require the gtneral liceriscea to provide tie NRC with specific information about the licensed devices. Co responding changes would also be made in 10 CFR part 32 on the transfer report!ng requirements imposed on persons authorized to distribute byproduct material. These changes are being made because there is inadequate acepunting for generally licensed devices, and also a general lack of awareness of the appropriate regulations on the part of general licensees.

It is anticipated that the proposed rules will ensure that these two problems are remedied by more timely contact between the general licensee and the NRC.

Sincerely,

, M Eric 5. Beckjord, 1 rector Office of Nuclear cgulatory Research

Enclosure:

Notice of proposed Rulemaking cc: Representative James V. llansen

/

j .. . !

?

I".

g w ,,

(.so'

(),y ,y'.f ,h. .*

/,,.

' " ~ '

IDENTICAL LET[ERS -TO:

Chairman John B. Breay Senata Subcommit~te~eonNucle)arReg cc: A16n K. Simpson Chairman' Philip R. Sharp Houce Subcomittee on Energy and Power cc ' Carlos J. Moorhead The Honorable Morris K. Udall, Chairman -

i Subcomittee on Energy and the Environment .

Comittee on Interior and Insular Affairs United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the information of the subcomittee is a copy of a Notice of Proposed Ruleyaking to be published irf the Federal Register. 10 CFR Part 31 establishes general licenses for the' possession and use of byproduct material '

contained in certain devices. The NRC is pro)osing to amend these regulations to require the general licensees to provide t1e NRC with specific information about the licensed devices. Corfesponding changes would also be made in 10 CFR Part 32 on the transfer reportirig requirements imposed on persons authorized to distribute byproduct material.< These changes are being made because there is inadequate accounting for generally licensed devices, and also a general lack of awareness of the appropriate regulations on the part of general licensees.

It is anticipated that the' proposed rules will ensure that these two problems are remedied by more timely contact between the general licensee and the NRC.

Sincerely,

/

Eric S. Beckjord, Director Office of Nuclear Regulatory Research

Enclosure:

Nr.tice of Proposed Rulemaking R. g tive James V. Hansen

'OfflCE:Kf:DRA: RDPid DD:DRA DD:GIR D:RES CHeltemes EBeckjord NAME: JTate . MFle m man SBahadur FC afizi is

.DATE: ~5/23/90 5/23/90 5/p/90 5/< /90 90 5/ /90 5/ /90 0FFICE: E00-NAME: JTaylor DATE 5/ /90' 0FFICIAL RECORD COPY

I

P The Honorable Horris K. Udall Distribution:

subj-circ-chron[BYPCONG]

Reading files ESDeckjord

'~ CHeltemes BMorris FCostanzi SBahadur JTelford SDolins EDO r/f OCA e

E Document flame:

BYP CONG Re~ destor'.10:

CC;tSBY Author's llame:

MATE Document Consnents:

CB 4/27/90 PARTS 31 & 32 CONGRESSIONAL LTRS 4

F Document Name:

10 CfR PARTS 31 AND 32 FRN Requestor's ID: -

BONSDY Author's Name:

itATE, J.

Document Connents:

nrcres bonsby Cookie 4/11/90 6

,e t' . l~l-90 hD 3h-\

D:cument H:me:

PARTS 31 32 CP p' i. * ' J 'l 0 Requestor's 10: k k-Af'9(

BON $BY Author's Name:

MATE Document Coments:

CB 5/11/90 comission paper on parts 31 & 32 neg, consent e

Fort The Commissioners From: Janes M. Taylor, Executive Director f or Operations

Subject:

PROPOSED AMENDHENTS TO 10 CFR PART ?l, 'UENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL," AND 10 CFR PART 32,

" SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL" purpose: To request the consent of the Commission for publication of the pro)osed rule changes to improve the public health and safety dy reducing the likelihood that generally licensed devices containing byproduct material would be improperly .

accounted for or inadvertently discarded.

Background:

In July of 1988, the staff initiated a rulemaking to ensure ethat devices used under the general license provisions of 10 CFR Part 31 were adequately maintained, pro >erly transferred, and properly discarded. During tie past several years there have been almost no inspections of general licensees. As a result, there was little or no data'to determine if the general license mechanism was an effective neans of assuring the public health and safety. The staff initiated this rulemaking af ter the completion of a study begun in 1983 which lasted about three years. As a result of the study, the staff concluded that there was an inadequate accounting for generally licensed devices and that there was a general Icek of awareness of the appropriate regulations on the part of general licensees. The staff further concluded that these two problems could be remedied by more frequent and tinely contact between the general licensee and the NRC. This conclusion p>nvided the basis for the proposed regulatory changes.

Contact:

Joseph J. Mate, RES 492-3795 e

_% - _,n._.. . .-

The Commissioners 2 Discussion: The proposed changes in Parts 31 and 32 would accomplish the following:

Section 31.2, " Terms and Conditions" - subjects each general licensee to the requirements of 10 CFR 30.9 which

~-

imposes certain requirements regarding the completeness and accuracy of information submitted to the Commission by licensees.

Section 31.5, "Certain 14easuring, Gauging or Controlling Devices"-deletesallreferencestospecificItcensesissued by Agreement States which authorize distribution of devices to persons generally licensed by Agreement States and requires generallicenseestoprovideNRCwithinformatIonaboutthe radioactive material used under provisions of a general license (includessuchitemsasnameandaddress, specific information about the device, name and telephone number of person responsible for controlling the use of the device, address where the device is located, and whether the specific requirements of Section 31.5 have been met).

Section 31.6, " General License to Install Devices 4 Genera 11y Licensed in i 31.5" provides explicit authorization to distribute devices to general licensees provided that the i 31.0 general licensee maintains a specific license from an Agreement State that authorizes distribution of such devices. Additionally, the general licensee in i 31.6 is not subject to the 180 day limitation per calendar year imposed by 10 CFR Part 150 on Agreement State licensees operating in non-Agreement States.

Section 32.51a, " Conditions of Licenses" - requires general licensees to provide users of devices with written instructions, precautions, leak testing requirements, transfer and reporting requ hements, and disposal options to users in order to ensure th A devices are used safely.and are properly transferred.

Section 32.52, " Material Transfer of Reports and Records"

- requires the distributor of the device, a specific licensee, to use a prescribed format, or to provide all of the informa-tion required by the format on a clear and legible record, when submitting transfer reports to the NRC. The format provides more detailed and complete information about the general licensees to whom the device was transferred and would be presented in Subpart E of Part 32, 6 32.310.

The Consnissioners 3 Reconsnendationr Unless the staff is instructed to the contrary within 10 days

~ '

from the date of this paper, the enclosed anendments to 10 CFR i Parts 31 and 32 will be issued as a proposed rule.

-Coordination: The Offices of Governmental and Public Affairs, Nuclear .

a'nd Administration co-Nr in L Material Safety and Safeguards,f General Counsel has a legal

these anendments. The Office o objection, James M. Taylor ,

Executive Director for Operations

Enclosure:

Proposed Rulemaking Package 4

I e

ry- E- ~ [,- -. _ y . ---..

4

The Commissioners 4 Recommendations: Unless the staff is instructed to the contrary within 10 days from the date of this paper, ine enclosed amendments to 10 CFR Parts 31 and 32 will be issued as a proposto ru'e.

Coordination: The Offices of Governmental and Public Affairs,,'iuclear Material. Safety and Safeguards, and Adminis'.-6 tion concur in these amendments. The Office of General Counse! has no legal objection.

James M. Taylor ,

Executive Director for Operations

Enclosure:

Proposed Rulemaking Package 4

1 I

i

See Previous Concurrence .

4 1

Offe: RDB:DRA:RES RDB:DRA:RES RDB:DRA:RES RDB:DRA:RES DD:DRA:RES DRA:RES D:RES Name: JMate:cb*- MFleishman*;SBahadur* .Costanzi*- BMorris* CHeltemes* ESBeckjord* i Data:' L5/30/90 5/30/90 5/30/90. 5/30/90 5/30/90 6/01/90 6/01/90 4 Offe: GC:0GC -D:NMSS EDO Name: WParler* RBernero* JTaylor .

Dste: 5/30/90 .5/21/90 / /90 '

0FFICIAL RECORD COPY

t r

9

. The Commissioners 4 Coordination:- The Offices Governmental and' Public Affairs, Nuclear Material >

Safety-and Safeguards, and Administration concur.in these- ,

- amendments. The Office-of General Counsel has'no legal '-

- objection. ,

James H. Taylor Executive Director for Operations

Enclosure:

[ ~ Proposed Rulemaking Package i

1 P

4

.0ffe: DRA:RESR%

.hf

RESRDdRA:RESR :RE *

.RES D S D:RE a

'Name:: JMte:cb . MFTeishman SBahadur C i N rs C temes ESBeckjord-

'Dato: f /34/90 4 /J /90- 6/p/90 J74 90 O/90 ( /90- 6// /90 Offe: GC:0GC D:NMSS ED0

.Name: WParler RBernero- JTaylor- .

Date:! S / 30/90 5'/21/90 / /90" "

6tt - 5et -0FFICIAl. RECORD COPY-r4 En ru n

'PhGE9- : P h c tS .

TheCommissidners 4:

4 Coordination:' The Offices Governmental and Public Affairs, Nuclear Material Safety and Safeguards, and Administration concur inLthese-amendments. The Office'of General Counsel has no. legal objection. ,

James M. Taylor Executive Director for Operations

Enclosure:

Proposed Rulemaking Package a

~

20ffc:- RDB:DRA:RES RDO:0RA:RES RDB:DRA:RES RDB:DRA:RES DD:DRA:RES -DRA:RES D:RES-Name:; JMate:ch MFleishman SBahadur.

- Costanzi BMorris Cileltemes- ES0eckjnrW

.Date: L-- ./90- / /90-*

- /- /90 / /90 / /90 !/ /90 / /90 no 04joc/

Offc: 0GCL ,k D:NHSS . EDO Name: 7 *a: r le r--

RBernero- JTaylor LDate: f/3D/90 L/:/90_: - / /90 0FFICIAL RECORD COPY

6 4 +

- n =

G Enclosure 1 FEDERAL REGISTER NOTICE 4

N-to e Enclosure 1 ,

FEDERAL REGISTER NOTICE 4

t

[7590-01]

NUCLEAR REGULATORY COMMISSION 10 CFR Parts 31,and 32 RIN 3150 - A034 Requirement for the Possession of Industrial Devices Containing Byproduct Material AGENCY: Nuclear Regulatory Commission. ,

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is proposing to amand its regulations governing the safe use of byproduct material in certain gauges-ahd other similar devices. The proposed changes, among other things, would require general licensees to provide the NRC information about the radioactive material used under the provisions that establish general domestic licenses for byproduct material. Corresponding changes would also be made in the transfer reporting requirements imposed on persons authorized to distribute byproduct material in devices to general licensees. Distributors of devices would be required to use a uniform e

format when submitting the quarterly transfer reports to NRC. The proposed rule is intended to improve public health and safety by reducing the likelihood that generally licensed devices containing byproduct

= material are improperly accounted for or inadvertently discarded.

DATE: The comment period expires 75 days after publication: Comments received after this date will be considered if it is practicable to do 1

..- - _ . - . . . . _ _ - -. .. . ~ - - -

4-T

+

so.:but the NRC is able to ensure consideration only for comments received on or before this date.

ADDRESSES: Mail written comments to the Secretary, U.S. Nuclear Regulatory Commission,. Washington, DC 20555, Attention: Docketing and Service Branch. Deliver comments to One White Flint North, 11555 Rockville Pike, Rockville, MD, between 7:30 am and 4:15 pm on weekdays.

Copies of the draft regulatory analysis, as well as copies of the comments received on the proposed rule, may be examined at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT: Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, tdiephone (301) 492-3795.

SUPPLEMENTARY INFORMATION:

Background

On February 12,1959 (24 FR 1089), the NRC amended its regulations to provide a gensral license for the use of byproduct material contained in certain luminous, measuring, gauging, and controlling devices producing light or emitting radiation. Under the current conditions for a general license, certain persons may receive and use a device

- containing byproduct material if the device has been manufactured and distributed in accordance with the specifications contained in a specific license issued by the NRC or by an Agreement State. A specific license 1

2

- - ~ _ - . . , . - - . - . . . . - .. .

is issued upon a determination by a regulatory authority that the safety features of the device and the instructions for safe operation are adequate and meet regulatory requirements, lhe general licensee is required to comply with the safety instructions contained in or referenced on the label of the device and to have the testing or servicing of the device performed by an individual authorized to manufacture, install, or service these devices. A general licensed device is a " black box," that is, the radioactive material is contained in a sealed source usually within a shielded device. The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. Thus, the general license policy is a mechanism to simplify the license process whereby a case-by-case determination of the adequacy of the radiation training or experiente of each potential user is not necessary.

Discussion In the past, general licensees have not been contacted by NRC on a regular basis because of the relatively small radiation risk of generally licensed devices. During the the past 30 years that devices have been used under the general license program, the operational history has been good. These devices have survived fires and explosions on many occasions without a total loss of shielding. They have been damaged by molten

~

steel, and hit by construction vehicles with only minor losses in radiation shielding while maintaining the integrity of the source capsule, 3

9 w ,

l None the less, there have been a number of occurrences involving generally licensed devices that suggest that better accounting for such ,

devices may be beneficial. For example, a gauge containing 340 m1111 curies of krypton-85 was improperly disposed of by transferring the device to a metal salvage yard that was not authorized to receive such a device. In another instance, a static eliminator bar with 22.5 mil 11 curies of americium-241 was sent to an unlicensed sanitary landfill.

Of course there have been other types of incidents involving NRC generally licensed devices including overexposures, damaged d,evices, leaking or contaminated sources, and equipment malfunctions. However, loss of accountability remains the most frequent incident and the predominant concern.

Because of these occurrences, the NRC's Office of Nuclear Material Safety and Safeguards (NMSS) conducted a radiological risk assessment addressing storage of devices in warehouses, disposal in scrap yards, incineration of waste, melting in a smelter, and disposal in a landfill.

Included in-the risk assessment was an incident at a steel company in 1983 (discussed in NUREG-1188 "The Auburn Steel Company Radioactive Contamination Incident") which probably represents a worst case scenario for generally licensed gauging devices. Although, individual doses were low and within guidelines for exposure of members of the public, the clean up costs were in excess of two million dollars.

In consideration of both the risk assessment and incidents like those noted above, the NRC conducted a three year sampling (1984 thru 1986) of general licensees (taken from the vendor's quarterly reports) to

. determine whether there was an accounting problem with gauge users under general licenses, and if so, what remedial action might be necessary.

4

_ ~ _ . - . _ _ . _ . . . _ _ . . _ . _ _ . . _. _ .

- l it-

+ 1 4

The sampling was conducted both by telephone calls and site visits. The sampling revealed several areas of concern-about.the use of radioactive material under the general license provisions. On the basis of the sampling, the NRC concluded that there is 1) inadequate accounting for these licensed devices and 2) a lack of awareness of appropriate regulations on the part of the user. The NRC further concluded that

. these two problems can be remedied by more frequent and timely contact between the general licensee and the NRC. This conclusion by the NRC provides the basis for the regulatory changes proposed in thi,s action.

An estimated 35,000 persons use products under a general license.

NRC regulations- that affect general licensees' responsibilities and that are presently being amended are 10 CFR 31.2, 31.5, and 31.6. Under 10 CFR 31.2, " Terms and Conditions," the general licensees are subject to certain brovisions of Parts 30 and also Parts of 19, 20, and 21. The proposed revision to $ 31.2 would also subject the general licensees to the requirements of 10 CFR 30.9, " Completeness and Accuracy of Information," which imposes certain requirements regarding the completeness and accuracy of the information submitted to NRC by licensees not now imposed upon general licensees.

10 CFR 31.4, "Information Collection Requirements: OMB approval,"

lists the various sections of Part 31 that contain approved information collection requirements. Paragraph b of f 31.4 is being amended to add S 31.6 to the approved listing. The OMB clearance package has been prepared and will be forwarded to OMB- for approval when .the proposed rule is published in the Federal Register.

10 CFR 31.5, "Certain measuring, gauging or controlling devices,"

provides for a general licensee to acquire, receive, possess, use, or 5

--a- m__-_-----

transfer byproduct materials. It also specifies the responsibilities of general licensees regarding the use of byproduct materials. Under the proposed revisions a new paragraph (c)(11) would be added to require the general licensee to provide specific information to NKU. This informa-tion would include the following: complete name and address; specific information about the device such as manufacturer, model number, number of devices, etc.; name, title, and telephone number of the person responsible for controlling the use of the device; address where the device is located or used; and whether tne specific requirements of S 31.5 (c) have been met. In addition a proposed revision to paragraph (b) of G 31.5 would delete all references to specific licenses issued by Agreement States which authorize distribution of devices to persons generally licensed by Agreement States.

At present, 10 CFR 31.6, " General license to install devices generally licensed in S 31.5," provides a general license to certain specific licensees from Agreement States to install or service devices used under S 31.5. The current regulation, (10 CFR 31.6) is not clear with respect to time restrictions. 10 CFR 150.20 (b)(3) imposes a 180 day per calendar year limitation on the activities of Agreement State Licensees in non-Agreement States. The proposed amendments to S 31.6 establish that an Agreement State licensee is authorized to distribute products to users of a general license and need not file an NRC Form 244 (Registration Certificate). Further, they are not limited to an amount of time that their activities are authorized. This practice is convenient to the NRC, Agreement States, and manufacturers because it reduces and simplifies paper work without increasing the threat to public health and safety. The proposed revision to conditions of the general 6

license provided in 6 31.6 would explicitly authorize distribution of devices to general licensees, provided that the S 31.6 general licensee maintains a specific license from an Agreement State that authorizes distribution of such devices. There is no time limit placed on the general licensen operating in non-Agreement States. Proposed paragraph (a) would require the general licensee to report to the NRC all persons receiving the device from tha general licensee, as specified in the proposed S 32.52. Proposed paragraph (d) would require the general licensee to supply to each of the recipients a copy of the ge,neral license issued under 6 31.5. Proposed paragraph (e) would require that written instructions and precautions be provided to persons serviciag the device. Proposed paragraph (f) would also require a person performing routine installation / servicing / relocation of these devices to notify the appropriate NRC regional office at least 3 working days prior to the start of the activities. The revisions are necessary to provide a level of periodic inspection of those activities that intentionally place a worker in direct contact with the device or an unshielded radiation source.- Obviously, the prior notification does not apply in cases where a radiological hazard exists due to accidents nr a malfunction of the device. To be consistent with the proposed modifications, the section heading would be amended to read " General license to install and distribute devices generally licensed in S 31.5." .

10 CFR 32.51a, " Conditions of licenses," presently imposes conditions on the application for a specific license to manufacture or initially transfer devices containing byproduct material to persons generally licensed under S 31.5. The proposed addition of paragraph (c) to S 32.51a would require specific licensees who hold a general license 7

l

to provide users of devices written instructions and precautions to ensure that the devices are used safely. In addition, these general licensees must provide any testing requirements, transfer and reporting requirements, and disposal options to such users.

10 CFR 32.52, " Material transfer reports and records," currently requires specific licensees authorized to distribute devices to general licensees to file transfer reports with the NRC on a quarterly basis.

Tne revised regulation prescribes the format to be used when submitting transfer reports to the NRC. The proposed format provides more detailed ,

and complete inforsction about the general licensee to whom the device was transferred. The format is presented in proposed Subpart E of Part 32, 6 32.310. If a licensee cannot use the prescribed format, they may provide all of the information required by the format on a clear and legible secord. In addition, specific licensees would now be required to identify a person responsible for meeting the requirements associated with the device rather than simply identifying a point of contact at the gener . licensee's location.

After receipt of the quarterly transfer reports from the specific licensee under S 32.52, the NRC would send letters to the general licensees who received the devices and ask them to verify in writing that they had purchased the devices contain(ng byproduct material and that they understand the requirements of the general license. The licensee would be required to respond to the NRC by letter and to verify safety-related information about the device and its location.

Thereafter, notices would be sent periodically to the general licensee requesting they verify that they still had the device, verify safety related information, and remind the general licensee of their regulatory 8

. ~ ~ . _ _

- - - -..-. . - _ - . . . . - . _ . - . . . ~ _ _ . ..- . .- ..- .. - .

4 5 responsibilities in using the device. The frequency of the inventory letters would range from every 1 to 3 years depending on the radiation risk associated with the device. Any failure to respond or any reports of lost devices would initiate NRC follow-up action.

Environmental Impact:- Categorical Exclusion 4

The NP.C has determined that the proposed regulations are the type of action described in the categorical exclusion 10 CFR 51.22(c)(3)(111). ,

Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.

4 Paperwork Reduction Act Statement

. The proposed rule amends the information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.) This proposed rule has been submitted to the Office of Manage-ment and Budget for review and approval of the paperwork requirements.

Public-reporting burden for this collection of information is estimated to average about 20 minutes per response, including time for reviewing instructicns, searching existing data sources, gathering and-maintaining the data needed, and completing and reviewing the collection of information. ' Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Information and Records Management Branch (MNBB-7714), U.S. Nuclear Regulatory Commission, Washington, DC 20555;

^

9 4

. . . , , , . - , - - . . - - , -. _ - - - - - . . .-e .

. - r,

i c3 and to the Paperwork- Reduction Project (3150-0016 and 3150-0001), Office ;

of Management and Budget Washington,'DC 20503. ,

4 Regulatory Analysis [

The NRC has prepared a _ draft regulatory analysis of this proposed regulation. The analysis-examines the cost and benefits of the alterna- ,

tives considered hy the NRC. The draft analysis is available for inspec-tion in the NRC Public Document Room, 2120 L Street, NW. (Lower Level),

Washington, DC. Single copies of the draft analysis may be obtained fron Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone: 301-492-3795.

4 a Regulatory Flexibility certification 4

Based on information available at this stage of the rulemaking 4

proceeding and in accordance with the Regulatory Flexibility Act, 5-7 U.S.C. 605(b), the NRC certifies that, if promulgated, this rule will not have a significant economic impact on a substantial number of-small entities. The NRC has adopted size. standards that classify a small entity as one whose gross annual receipts do not exceed $3.5'millioniover-a 3 year period. The proposed rule affects about-35,000 persons using i

products under this general license, many of whom would be classified as

-a small entity. However,Lthe NRC believes that the economic impact of the proposed requirements on any general licensee would be negligible.

The proposed rule is being issued to better' determine the identity of the 10 t .

, 9- - - , + - , -,et-- y_ - -,,w.--n-..sw.,. , .w.,, , v,,

general licensees and to ensure that the general licensees understand and

- comply with regulatory responsibilities regarding radioactive devices.

Backfit Analysis-The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to these proposed rules and therefote a backfit analysis is not required because these proposed amendments do not involve any provisions that would imptie backfits as defined in 10 CFR 50.109(a)(1).,

List of Subjects in 10 CFR Parts 31 and 32 j 10 CFR Part 31 Bypeoduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and record-keeping requirements, and Scientific equipment.

10 CFR Part 32 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements, and Scientific equipment.

For the reasons set out in the preamble and under the authority of the Atomic Energy. Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 31 and 32:

11

PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

1. The authority citation for Part 31 continues to read as follows: Authority: Secs. 81,161,183, 68 Stat. 935, 948, 954, .as amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842).

Section 31.6 also issued under sec. 274, 73 Stat 688 (42 U.S.C.

2021).

For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.

2273); $$31.5 (c)(1)-(3) and (5)-(9), 31.8(c), 31.10(b), and 31.11(b),

(c), and (d) are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b); and $$31.5 (c)(4), (5), and (8), and 31.11(b) and (e) are-issued under sec.161o, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).

. a

2. Section 31.2 is revised to read as follows:

9 31.2 Terms and conditions.

The general licenses provided in this part are subject to the provision of SS 30.9, 30.14(d), 30.34(a) to te), 30.41, 30.51 to-30.63, and Parts 19, 20, and 21 of this chapter1 unless indicated otherwise in the language of the general license.

3. In 6 31.4 paragraph b is revised to read as follows:

S 31.4 Information collection requirements: OMB approval.

Attention is' directed particularly to the provisions of the regulations

~

in Part 20 of' this chapter which relate to the labeling of containers. -

12

~ - .. - . . - - . - . - - - . .-

(a) * *

(b) The approved information collection requirements contained in this part appear in il 31.5, 31.6, 31.8, and 31.11, 4.. Ini31.5, paragraph (b)isreviseuandParagraph(c)(11)is added to read as follows:

6 31.5 Certain measuring, gauging, or controlling devices.2 (b) The general license in paragraph (a) of this section applies only to byproduct material contained in devices that have been manufac-tured or initially transferred and labeled in accordance with the speci-fications contained in a specific license issued pursuant to i 32.51 of this chapter or in accordance with the specifications contained in the a

general license of 5 31.6.

(c)

(11) Shall respond within 30 calendar days of receipt of a request from the Nuclear Regulatory Commission to verify the following information and any other such information as may be requested by the Commission as it relates to the general license.

(i) Name and complete address of the general licensee.

(ii) Identification of specific information about the device, such' as: the manufacturer, model number, the number of devices, type of iso-tope, and who has performed what service on the device since the last reporting period.-

2 Persons possessing byproduct material in devices under a general licens_

in 5 31.5 before January 15, 1975. may continue to possess, use, or transfer (Footnote Continued) 13

- . ~ .. .- . - . - -.- ... . _--

(iii) Name, title, and telephone number of the person who is responsible for the device and for ensuring compliance with the appropriate regulations and requirements.

(iv) Address at which ti'e devices are located or used.

(v) Whether the require 6ents of S 31.5(c)(1) through 31.5(c)(10) have been met.

5. Section 31.6 is amended by revising the section heading and the introductory paragraph and by adding paragraphs (a), (d), (e), and (f) to ,

read as follows:

S 31.6, General license to distribute, install, and service devices generally-licensed in S 31.5.

Anyeperson who holds a specific license issued by an Agreement State authorizing the holder to manufacture, distribute, install, or service devices described in S 31.5 within the Agreement State is hereby granted a general license to distribute, install, or service the devices in any non-Agreement State for an unlimited period of time, and a general license to distribute, install, ot service the devices in offshore waters, as defined in S 150.3(f) provided that:

f (a) The Agreement State licensee files the appropriate transfer reports as required by S 32.52.

- a a a a *

(footnote Continued) that material in accordance with the labeling requirements of 5 31.5 in effect 1on January 14, 1975.

.14

(d) The person shall furnish a copy of the general license contained in S 3'.5 of this chapter to each person who is responsible for i

the byproduct material and for ensuring compliance with the appropriate regulations and requirements.

(e) The person,,shall provide the individual responsible for service of the device with written instructions and precautions necessary to ensure its safe installation, operation, and service. These instructions shall include leak testing requirements, transfer and reporting requirements, disposal options including possible costs, and , reporting requirements for lost or damaged devices.

(f) The persons performing routine service / installation, or relocation of devices shall notify the appropriate NRC Regional Office listed in Appendix 0 of Part 20 of this chapter at least 3 working days prior toaengaging in such activities in Non-Agreement States. The notification shall include the date and location of the activity that will be performed. Prior notification does not apply in cases where a radiological hazard exists due to accidents or malfunction of the device.

PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TPANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

6. The authority citation for Part 32 continues to read as follows:

Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,.as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as ,

l amended (42 U.S.C, 5841).

15

For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.

2273); SS 32.13, 32.15 (a), (c), and (d), 32.19, 32.25 (a) and (b), 32.29 .

(a) and (b), 32.54, 32.55 (a), (b), and (d), 32.58, 32.59, 32.62, and 32.210 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C.

2201 (b)); ar.d SS 32.12,32.16,32.20,32.25(c),32.29(c),32.51a,32.52, 32.56, and 32.210 are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).

7. Section 32.51a is amended by adding paragraph (c) to read as follows:

S 32.51a same: Conditions of licenses.

a a a n

a (c) Furnish the individuals identified under S 31.5(c)(11) or

$31.6(d) with written instructions and precautions necessary to ensure safe installation, operation, and service of the device. These instructions must include the leak testing requirements, transfer and reporting requirements, disposal options including possible costs, and reporting requirements for lost or damaged devices.

8. Section 32 52 is revised to read as follows:

S 32.52 Same: Material transfer reports and records.

Each parson licensed under S 32.51 or S 31.6 to initially transfer devices to generally licensed persons shall:

1 16

l 9--

+

... 7 T

'(a) Report'to the Director of the Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commissio.1, Washington,- DC

20555, and send a copy of.the report to the appropriate NRC regional office listed in Appendix D of Part 20 of this chapter, all transfers of

- "such devices to persons for use under the general license _in 4 31.5 of this chapter. The report should be provided in the format pretented in ,

_Subpart E of Part 32, 6 32.310. " Transfer Report Format" or the report' i .may be provided on a clear and legible record as long as all of the data required by the format is included. If one or more intermediate-persons ,

s temporarily possesses the device at the intended place of use prior to its possession by the user, the report must-include the same information for each intermediary as in Subpart E, 6 32.310, and clearly designate that person as an intermediary. If no transfers have been made to e

persons generally licensed under i 31.5 during the reporting period, the report shall so indicate. The report must cover each calendar quarter and be filed within 30 days of the end of the calendar quarter.

(b) Report to~ the responsible Agreement State agency all transfers

.of such device (s) to persons for-use under a general license in an Agree-5 ment State's regulations that are equivalent to 5 31.5. The report-must be provided in the format in Subpart E, 6 32.310. " Transfer Report Format." If one or more intermediate persons temporarily possesses the device at the intended place of use prior to its possession by the user,-

the-report must include the same information for each intermediary as in Subpart E, 9 32.310, and clearly' designate that person as an intermediary.- lf no transfers have been made to persons. generally licensed under $ 31.5 during~the' reporting period, the report must so 17

, w .. - .. . . . - .- - .. -. -. .. -. . _. . . . - . . .

l l

indicate. The report must cover each calendar' quarter and be filed I

within 30 days of the end of the calendar quarter. *

(c) Keep records of all transfers of such devices for each general licensee and in corpliance with the above reporting requirenents of

~~

l 32.52.-Records required by this section must be maintained for a period of 5 years from the date of the recorded event.

9. Subpart E (Section 32.310) is added to 10 CFR Part 32 to read as follows:

.1 Subpart E - Report of Transfer of Byproduct Materials

$32.3j0TransferReportFormat Each person licensed to transfer devices to persons generally licensed under 5 32.31 shall use the format presented in this section to submit the reports required by-l 32.52.

18

Subpart E-Report of Transfer of Byproduct Materials

, Section 32.310 - Transfer Report Format NAME OF VENDOR AND LICENSE NUMBER REPORTING PERIOD FROM TO-GENERAL LICENSEE INFORMATION COMPANY NAME, STREET, CITY, DEPARTM'ENT STATE, ZIP CODE PERSON RESPONSIBLE FOR CONTROL OF THE DEVICE 9AME AND TITLE TELEPHONE NUMBER 4

FOR EACH DEVICE PROVIDE THE FOLLOWING MODEL SERIAL ISOTOPE ACTIVITY AND UNITS NUMBER NUMBER

- . . ~ - . . . - . .. .-. . . . . . - - . ~ . . - ._- .. . . - . .-- -

1 i

Subject:

Requ'irements.for.the Possession of Industrial Devices

~

Containing Byproduct Material (RIN 3150-A034).

Dated-at Rockville, Maryland this ' day of 1990.- -

for the Nuclear Regulatory Comission.

i.

James M.' Taylor.

Executive Director for operations.

4 4

e w

20 wv ~

Enclosure 2 .

Draft Regulatory Analysis a

1 c

l t

1 i

(

I l

l

)

"- r

-e ARGONNE NATIONAL LABORATORY '

9700 South Cass Avenue, Argonne,.lllinois 60439 4

a

-DRAFT - DO NOT CITE REGULATORY ANALYSIS: -

REQUIREMENTS FOR POSSESSION OF DEVICES CONTAINING BYPRODUCT MATERIAL 4

s a by Philip H.-Kier Environmental Assessments and Information Sciences Division May 1990 work sponsored by U.S.-NVCLEAR REGULATORY COMMISSION

_ Office of Nuclecr Regulatory Research

.w -- , . - - - _ ._ _ .. - , - .-_. .,

t

(

l

}

i i

i CONTENTS

' A B S T RA C T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1 STATEMENT Of THE PR0BLEM............................. 4................

1.1 Background......................................................... "

1.2 NRC Study of Conformity with General License Conditions............

1.2.1 Part i Results...............................................

1.2.2 Part 11 Results..............................................

2 OBJECTIVES.............................................................

3 AllERNATli;l........................................................... >

3.1 No Change..........................................................

3.2 Modify Reporting Requirements......................................

3.2.1 Knowledge of Conditions in General Licenses. . . . . . . . . . . . . . . . . .

3.2.2-Verification of Conformity with General License Conditions...

4 00NSLQUENCES........................................................... !

4 4.1 Benefits of Alternative 2..........................................

4.2 Costs of Alternative 2.............................................

4.2.1 Costs of Revisions to 10 CfR 31.5............................

4.2.7 Costs of Revisions to 10 CFR 31.6............................

4.2, IRC Development and implementation Costs. . . . . . . . . . . . . . . . . . . . .

4 2 . 4 S u mma ry o f C o s t s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5 DECISION RAT 10NALE.....................................................

6 IMPLEMENTATION.........................................................

7 'ffECT ON SHAll ENTITIES...............................................

TABLES

- 1 Types of Costs Likely to be Avoided by Proposed Revisions. . . . . . . . . . . . . .

2 Summary of Costs to NRC and Industry of Proposed Changes................

iii

L t

ABSTRACT A survey of holders of general licenses issued by the U.S. Nuclear Regulatory Commission for possession and use of certain devices containing byproduct material showed that there has been several instances of record where devices were improperly maintained, improperly transferred, cr --4 inadvertently discarded. The survey also indicated that general licensees are frequently unaware that there are certain license conditions that must be complied with relating to the possession and use of these devices. A lack of compliance with general license conditions has led to improper disposal of the devices, which can cause a small radiological risk to public health and safety. Costs ranging from $50,000 to $2,200,000 have been incurred in cleanup and disposal of contamination resulting from incidents of improper disposal, with additional costs incurred for the staff efforts of regulatory 6

agencies.

The staff is proposing to revise certain regulations contained in 10 CFR (Code of Federal Regulations), Parts 31 and 32, to improve compliance with general license requirements. The revisions would require manufacturers transferring such devices (specific licensees) from Agreement States to provide a copy of the general license to the general licensee. The revisions would also require the general licensee to verify compliance with the general license requirements soon after receiving the device and periodically thereafter.

The Commission has-an obligation to take reasonable steps to help -

ensure compliance with its regulations when noncompliance increases the risk of radiological. contamination. A regulatory analysis of the costs and iv

1 benefits of the proposed revisions has been completed. Costs to be borne by the Commission for the proposed revisions were estimated: $62,000 for l

4 development / implementation and $71,000 for annual operations. The annual industry operations costs were estimated to be $458,000. The annual industry j i costs translates into a total Itfetime implementation ec<t ner. device of less than $10, for many devices, this is less than 1% of the purchase price.

) The i staff-concluded that, because the proposed revisions would reduce the risk of i radiological contamination from improperly maintained or disposed of devices, l these costs would be justified. -

L L l N

[

4 9

6 J P 4

y

(

,,,....,,,,,,-w._n.-,n-.n,.,.,.n , . , , , , , . , , ,,=,...n .,, , n n , n _ ,wa,,c,,, .a,, ..,_,n.,,,,-,,.n, .n n. n-m.,--,. , , , ,

P I

I REGULATORY ANALYSIS:

REQUIRENENTS FOR POSSESSION OF DEVICES CONTAINING BYPRODUCT MATERIAL 1 STATENENT OF THE PROBLEN

" ^

1.1 BACKGROUND

On February 12, 1959, (24 FR 1089) the U.S. Nuclear Regulatory Commission (NRC or Commission) amended its regulations to provide in 10 CFR 31.5 for general licenses for the possession and use of byproduct material in certain 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. The Commission's regulations apply only in 'Non-Agreement States", those that have not entered into an agreement with the NRC under Section 274 of the Atomic Energy Act and have the authority to regulate the manufacture and use of such devices.

" Agreement States" (i.e., states that have entered into such an agreement with theNRC)havesimilarregulationstothoseoftheCommission. The devices must have been manufactured in accordance with the specification contained in a specific license issued by an Agreement State or by the Commission under 10 CFR Parts 30 or 32 for manufacturers in Non-Agreement States.

At present, thare are about 150 " specific licensees" (i.e., holders of specific licensees from-the NRC or from an Agreement State for the manufacture, servicing, or repair of the regulated devices). These specific licensees are authorized to distribute the devices. There are also approximately 35,000 " general licensees" (i.e., holders of a general license w.,

I I

2 f l

for possession and use). General licensees possess an estimated 400,000 devices to which Commission regulation apply.

A general licensee under the jurisdiction of the Commission is currently required to follow safety instructions on device labels, to test or service a device, or to have such testing or servicing performed by the supplier or other specific licensee authorized to manufacture, install, or service such devices. General licensees are also required not to abandon a device and to maintain records of testing and servicing of the device.

Damaged or lost devices must be reported.

The Commission is notified as follows when possession of devices containing byproduct material is transferred. A specific licensee is required by 10 CFR 32.5?da) to report, quarterly, all transfers to general licensees.

These reports must identify each general licensee by name and address (including, for an organization, the name or position of a person who may act as a point of contact between the Commission and the general licensee); the type and model number of the device transferred; and the quantity and type of byproduct material contained in the device. A general licensee is required by 10 CFR 31.5(c)(8) to transfer or dispose of such a device only to the holder of a specific license pursuant to parts 30 and 32 or to the holder of a license issued by an Agreement State; a ilmited exception to inis requirement is provided by 10 CFR 31.5(c)(9), wherein the device can be transferred to another general licensee. A transfer of a device by a general licensee to either a specific licensee or another general licensee must be reported to the Commission within 30 days of the transfer.

3 1.2 NRC STUDY OF CONFORMITY WITH GENERAL LICENSE CONDITIONS The NRC traditionally has had little contact with general licensees other than through the reporting requirements described above. Improperly maintained, transferred, or' discarded devices may impose an unnecessary risk to the public health and safety. Many devices containing byproduct materials are sturdily built. If devices are transferred to a scrap metal processor, however, the sealed source capsule can be breached during processing, contaminate the entire batch of scrap metal, and consequently, expose the public to radiation from the reused r W 1, Currently, the regulations do not contain any procedure for verifying di t canoral licensee has knowledge of or is conforming with the rules and regulations of 10 CFR 31.5.

The ConvQssion conducted a study from 1984 through 1986 (" General License Study") to ascertain the extent of compliance with general license conditions. Because of the broad rar.go of devices covered under 10 CFR 31.5, the study was divided into two parts. The first part covered industrial gauging and measuring devices, such as large-scale level, density, and thickness monitors. There are approximately 16,000 devices in this category containing sources with activities in the 0.5 to 1 curie range, licensed by the Commission. The second part of the study involved self-luminous signs, analytical instruments such as x-ray fluorescence spectrometers or liquid scintillation spectrometers, and smaller-scale thickness, density, and level gauges. The results of the study summarized below were taken from an unpublished NRr. report entitled " General License Study Report."

r 4

l 1.2.1 Part ! Results 1he Part I study included 228 site surveys of general Itcensees by the study task force and 132 inspections conducted by NRC regional offices. Some [

of the Agreemerit States also contributed data to the ' General License Study."

1he information gathered by the study, although from a small sample of general licensees possessing large-scale gauges, clearly established that there is a compliance problem. Among the findings of Part I were the following:

. Approximately 15% of the general licensees could not '

iccount for all of their gauges.

. A majority of general licensees did not notify the i Commission of transfers of their gauges, improperly transfgrred th* gauges, or transferred them without properly not. iag the Commission.

. At least 25% ci ae general licensees were not performing required leak tests or maintaining leak-test records; or they were not inspecting a gauge's on/off shielding mechanisms or not inspecting them as required.

Am eement States reported incidents of thickness gauges being found in a landfill and in an abandoned paper mill, 1.t' . 2 Part !! Results Part 11 of the study covered devices that vary greatly in design and use. The range of problems encountered in Part 11 is exemplified by the

' problem. relating to self-luminous exit signs and beta backscatter gauges.

Exit' signs, which are one of the most widely..used of these devices,- contain >

9

_. . .u .._ . . , _ - ...:_.. ___.; _

5 tritium gas that excites phosphorous-coated glass tubes to give off light.

They are used in places where wiring of electrical signs would be difficult or expensive to do. Beta backscatter gauges contain a small sealed source and a radiation detector that measures how much radiation is reflected back trom a material sample. The concern about these devices is the accountability of the removable source which is only about one inch in diameter. Ninety eight interviews were conducted on these types of devices. The findings of Part !!

are summarized below:

. Nonconformity with the general license conditions was very widespread.

. Only 16% of the general licensees for exit signs t;ere aware of the regulatory requirements.

. Manufacturers and distributors frequently underreport the number of signs sold to general licensees. General licensees (electrical distributors and contractors) report having about 30% more signs than were listed in quarterly reports of the manufacturers.

. Three cases involved missing sources from beta backscatter gauges.

. Only 45% of those surveyed for backscatter gauges were aware of the general license conditions.

. Vendors reports did not accurately reflect the number of radioactive sources in the possession of general licensees.

As a result when sources were returned to the manufacturer

t 6

for disposal, NRC was not notified. llence, NRC records were not accurate.

9

t,.

7 2 DBJECTIVES

'The objective of the proposed revisions is to improve the protection of public health ~ and safety by reducing the likelihood that generally licensed devices containing byproduct material are isproperly ' accounted for or inadvertently discarded. The proposed revisions would achieve this objective in two.wayst by requiring that specific licensees in Agreement States provide a general licensee under of the jurisdiction of the Commission with a copy of the general ~ license when transferring a device; and by requiring the general licensee to verify compliance with the conditions of the general license imposed by the rules and regulations contained in 10 CFR 31.5 soon after receipt of a device and periodically thereafter.

e

.I I

T

8 3 ALTERNATIVES The following are the only alternatives to be considered in this regulatory analysis.

3.1 NO CHANGE This alternative would continue the status quo by making no change in the current regulations governing devices containing byproduct material.

3.2 MODIFY REPORTING REQUIREMENTS This alternative would amend certain regulations contained in 10 CFR Parts 31 and 32 to help ensure that devices containing byproduct material are maintained and transferred properly and are not inadvertently discarded The general mechanism to be used is to require general licensees to verify compliance with the conditions imposed by general licenses.

3.2.1 Knowledge of Conditions in General Licenses The General License Study indicated that many persons with operational responsibilities for devices containing byproduct material are unaware that NRC regulations impose general-license requirements on such devices, and, therefore, that they may not be complying with the general-license conditions.

One reason for this situation is that holders of specific licenses issued by Agreement States are not required to inform general licensees of the conditions of general licenses. This is in contrast to holders of NRC specific licenses, who are required by 10 CFR 31.51a to furnish a general licensee transferee with a copy of the 10 CFR 31.5 general license or an

9 Agreement State equivalent. The proposed revisions would add a subsection (d) to 10 CFR 31.6 that requires holders of specific licenses issued by Agreement States to furnish a copy of the general license contained in 10 CFR 31.5 to transferees under the Commission's jurisdiction.

A second reason for noncompliance is that the individual within the organization of the general licensee who received the copy of the general license conditions did not inform the individual with operational responsibilities. 10 CFR 32.52 requires that the specific licensee report to NRC or the Agreement State agency the name and/or title of the individual who constitutes the point of contact between the NRC, or the Agreement State agency, and the general licensee. The General 1.icense Study indicated that this individual,6who is frequently in the purchasing department, did not inform the individual who uses the device of the general license conditions; or that high personnel turnover destroyed the organization's knowledge of the license conditions. An amendment to 10 CFR 32.52 would require that a specific licensee report to NRC, or an Agreement State agency, information on the devices and the general licensee transferee using the format depicted in the proposed 10 CFR 32.310. This format calls for identification of the person responsible for meeting regulatory requirements associated with the device rather than the " point of contact." This change means that the general licensee would be informed of a specific individual who is responsible for ensuring compliance with the general license conditions, and, if that individual leaves the general licensee, that another must be appointed in his or her stead.

l 1

i 10 :

Proposed subsection (c) of 10 CFR 32.51a would also help ensure that users of devices are aware of the conditions in the general license. It would ,

I provide that the responsible user be furnished with written instructions and !

~ '

precautions necessary to ensure safe installation, operation, service, and disposal of the device.

3.2.2 Verification of Conformity with General License conditions Currently, the only comunications between a general licensee and NRC is the requirement that the NRC be notified when a device containing byproduct material is transferred or disposed of. The proposed amendments, in a new l item 11 to 10 CFR 31.5(c), would require a general licensee to respond within i 30 days to requests from the Commission for verification of information ;

relating to the general licen.e and the general licensee. One new requirement ,

would reinforce the importance of accuracy and completeness in responding to the Comission's request; 10 CFR 31.2 would be revised to make a general license subject to 10 CFR 30.9, which requires that information provided the Commission be accurate and complete. ,

it is envisioned that the first request for verification would be made shortly after NRC receives notice from specific licensees in the quarterly report-that devices containing byproduct material have been transferred to a general licensee. This first verification request would offer greater assurance that a general licensee is informed of its regulatory responsibilities._ The NRC would then make periodic requests for verification to remiad general licensees of their regulatory responsibilities and to reduce

- * -e,-= , y +,,w - --

r-----c-v -.,wy. w-...y-,-w.--..y. -,.-ywm . . , --.-e- .,-w,wm,- ,,.wr-r + . - - -,- --

i 11 the likelihood that devices containing byproduct material are illegally

l transferred or inadvertently disposed of. !

NRC recognizes specific licensees of Agreement States as having ,

equiv'alentregulationsanddistributionauthorizations. However, there is no uniform requirement equivalent to the requirement in 10 CFR 32.52 that ;

transfers be reported to NRC. Thenewsubsection(a)of10CFR31.6would' l 1.

require such reporting in a format that transmits information needed by NRC to ensure the safe use of the radioactive material.

O I

i

4 12 4 CONSEQUENCES lhe estimates of costs and benefits of the proposed revisions are based on the guidance found in NUREG/BR-0058, " Regulatory Analysis Guidelines of the

~

U.S.NuclearRegulatoryCommission"(" Guidelines")andNUREG/CR-3568,"A llandbook for Value-impact Analysis" ("Ilandbook"). The convention used in regulatory analyses is that costs and benefits are measured in terms of changes from the status quo. As for Alternative 1, which is to make no changes in the current regulations, and which represents the status quo, there are no costs or benefits associated with it.

4.1 BENEFITS OF ALTERNATIVE 2 As discussed in Sec. 1.2 of this report, there is lack of compliance with general license conditions. Such noncompliance reduces accountability and increases the risk that the devices containing byproduct material are somehow disposed of in a way that may endanger the public health and could entail expensive investigation, cleanup, and disposal activities. The proposed revisions will undoubtedly improve accountability for the subject devices and also improve the protection of the public. There have been several incidents involving industrial and medical devices that have endangered public health and safety and that have required expensive cleanup operations. Although Sec. 31.5 general licenses were not involved in these incidents, they could be involved in similar incidents. Thus, the proposed revisions will reduce the likelihood of incidents similar to the ones described below, which involve contaminated steel, and other incidents involving improperly maintained or disposed-of devices, i

l

.. l 13 There was a radioactive incident at the Auburn Steel Company in Auburn, N.Y. Auburn Steel Company operates a 'minimill" that recycles scrap metal into steel bars. The incident is recounted in "The Auburn Steel Company RadioactiveContaminationincident"(NUREG-ll88). One day in 1983, approximately 25 curies of cobalt-60 was inadvertently melted, contaminating 120 tons of steel. The source or sources of the cobalt-60 were not identified, but the primary candidates were an industrial radiography source and a very old teletheraphy source. The cost of decontaminating the plant and disposing of the radioactive waste was estimated to be in excess of $2.2

+

million. This figure does not include the costs arising from lost steel production or the costs to the Agreement State for its regulatory oversight of the decontamination process.

A more serious incident occurred in Mexico in 1984 and is recounted in

" Contaminated Mexican Steel incident" (NUREG-1103). A cobalt-60 teletherapy unit having a source of 1,003 curies had been exported from the United States to a medical center in Juaret, Mexico, in 1977. During loading in Mexico, the source encapsulation was intentionally ruptured, and some of the tiny pellets of cobalt-60 metal were dislodged from the capsule, contaminating a truck and its wake, lhe ruptured source was sold to a scrap yard as scrap metal; the scrap yard sold the contaminated steel scrap to two foundries, where it was made into reinforcing bars (rebars) and restaurant chair legs. The incident

. was discovered when a truck tripped a radiation monitor at the los Alamos Scientific Laboratory. By that time, these contaminated products had been !

distributed throughout the United States. The incident required about eight l e

e, 9 e- ,

3 - , , - L.--+ -,..# --- * .--e. _.m y m g --J , yiw--- _-.p-, ., e g gr ., 7m,_, y, - -..-..re ,,--y.

I

.9 14 ,

staff-years _of effort and approximately $233,000 to locate and recover the l contaminated products in the United States.

Incidents at steel plants in South Carolina, California, and Alabama, involving cesium gauging devices, have also occurred. Cleanup and disposal >

costs for the South Carolina incident were between $400,000 and $500,0001 for the California incident, approximately $1,000,000; and for the Alabama incident, between $50,000 and $$00,000. Table I summarizes these costs.

f 4.2 COSTS OF ALTERNATIVE 2 The proposed revisions of 10 CfR 31.5 and 31.6 would result in costs to three types of entities: (1) specific licensees (2) general licensees; and (3) the Commiss&on. There would also be costs to the Commission associated with the rulemaking process.

4.2.1 Costs of Revisions to 10 CFR 31.5 The proposed revision would require general licensees to respond to requests from the Commission for verification of information relating to their general licenses. This information would help the Commission verify the location of devices containing byproduct materials and confirm compliance with the general-license conditions imposed by its regulations. The Commission-plans to send a general licensee a request for verification soon after a quarterly report is received from a specific licensee indicating that the general licensee had been shipped one or more devices. This request would cover only those devices shipped during the quarter. The Commission also would periodically send each general licensee a request for verification

4 4

15 covering all devices in' the possession of the general licensee. This planned procedure would require eight steps, each step involving a cost to either the general licensee or the Conmission.

Step 1. The proposed revision would require the Commission to create a computerized directory of devices that contains, as a minimum, the information required by the Section 32.310 format. This cost would be characterized by the llandbook as an NRC implementation cost. However, this directory has aircady been created and is storing information obtained from specific licensees pursuant to current regulations. Since the cost of creating the computerized directory has already been incurred regardless of whether the proposed rule in issued, it is a sunk cost and therefore outside the scope of this analysis.

Stop 2. NRC would have to enter information from the Section 32.310 format into the Step 1 directory. There would be a Section 32.310 form for each shipment that occurs each quarter. This cost would be characterized by the Handbook as an NRC operations cost. There are approximately 5,000 shipments per quarter to general licensees under NRC's jurisdiction (i.e., in Non-Agreements States), and it is estimated to take a clerk 2 minutes on the average to enter the information on this form in the directory, from NUREG/CR-4627, " Generic Cost Estimates", Abstract 5.2.(Revision 1), the composite NRC labor costs in undiscounted 1987 dollars is approximately

t 16 i 8

7 o k Avolded by o sed R v sions i Location of Radioactive Range of Cleanup Contamination incident Costs ($1000) :

Auburn, N.Y. 2,200 Juarez, Mexico 233(inU.S.only)

South Carolina 400-500 California 1.000 Alabama 50-500 i

L F

i w+2..-. , 6 -.mi< y ww.,-...w-- .y .e--- y y.. -ac, ,_,-.,yy4w y ..-,.,ye,,,i. 7.y-,,,,--,..w. y,,---w---#--e- vvs--#yy-vg--

<tw%--.-.--+ -eu.- e,,- g ---w #. +r wW-*=*-*W--af

i 17

$40/ hour (hr). The cost per year (yr) of this step would then be: [

Cost (step 2)=4 quarters /yrx$1.33/ shipment ($40/hr9 ,

30 shipments /hr) x 5000 shipments / quarter =

$27,000/yr However, this directory is already being maintained so that this cost, too, is a sunk cost and therefore outside the scope of this analysis. ,

Step 3. The planned procedure would require the Comission to mail a request for verification to each general licensee that received a shipment of devices during a quarter. This step would be characterized oy the Handbook as an NRC operations cost. In estimating the cost of this step, it is assumed that the Commission would use the information from the specific licensees ,

stored in the directory and that each request would be computer-generated. It is estimated that the cost of generating and mailing each request is about

$1.25($1.00 forstuffingenvelopesand$0.25forminimumpostage). The annual cost of this step would then be:

Cost (step 3) = 4 quarters /yr x 5,000 shipments / quarter x

$1.25/ shipment = $25,000/yr.

-Step 4. A general licensee would have to respond to the Commission's request for verification for those devices transferred to the general licensee during the' quarter. The GLneral 1.icense Study found that the average time required to locate and verify license conditions for all devices in the; possession of a general licensee was approximately 30 min. As the initial b

verification request pertains only to those devices received during a quarter,

(

,_ _ _ _ ,_ _, . 2 ,_ __ _ . . _ _ . _ _ , _ _ . _ _ . _ _ - - . _ _ _

. i

- I

+-

(

i 18 ;

L it is estimated that it would take a general licensee about 15 minutes of ;

staff time to comply. Assu-4ng that the cost to industry of staff time is also $40/hr, the annual cost f this step, which is characterized by the :

Handbook as an Industry operations cost, is estimated as: ;

Cost (step 4) 4 quarters /yr x 5000 shipments / quarter x

$10/ shipment =$200,000/yr step 6. When the Commission receives a response from a general licensee, it must log in the response on the computerized directory or somehow record that verification has been received, it is assumed that the staff ,

effort associated with this step costs $1 per response (40 responses processed perhour). Theennnual cost of this step, an NRC operations cost, would be estimated as:

Cost (step 5) - 4 quarters /yr x 5,000 shipments / quarter x

$1/ shipment - $20,000/yr The Commission is also planning to mail periodic requests to verify compliance with general license conditions for all devices in the possession ;

of the general licensees. These periodic verification requests would repeat steps 3-through 5 but would differ from the initial verification requests in the number mailed annually. In this analysis, it will be assumed that one-third of the approximately 35,000 general licensees under NRC's jurisdiction would receive a verification request annually.-

Steps 6 & 8. The cost to the Commission of sending a verification request _and processing the response has been estimated above to be $2.25. The L - . - . , ---

4

~

19 annual cost to the Commission of the periodic verification requests is estimated as:

l Cost (steps 6&8)=11,667 requests /yr x $2.25/ request = $26,250 Step 7 1he cost to a general licensee of responding to a periodic !

verification request is greater than the cost of responding to the initial request because the former covers all devices in the possession of the general licensee.- As discussed earlier, it is estimated that one-half hour of staff time is required for verification for all devices. The annual costs to general licensees of responding to periodic verification requests is thent Cost (step 7) = 11,667 requests /yrx$40/hrx e 0.5 hr/ request = $233,340/yr l To summarize, it is estimated that the annual operations costs of the '

proposed revision of 10 CfR 31.5 are $433,340 for general licensees and ,

$71,250 for the Commission in undiscounted 1987 dollars. These costs do not '

include costs to '.he Commission of creating and maintaining a computerized directory of devices, which are considered sunk costs.

4.2.2 Costs of Revisions to 10 CFR 31.6 The proposed revisions add subsections (a) and (d) to 10 CFR 31.6 4 which may entail some costs to holders of specific licensees issued bu Agreement States. There are approximately 150 specific licensees in iAv

, United States, of which approximately 90 hold licensees issued by Agreement l

~

20 States and approximately 60 hold licenses issued by the Commission. Only the former are affected by the proposed revisions.

Subsection (a). This new subsection wou5d require holders of specific licenses from Agreement-States to file with the Comission the Section 32.310

, form for each shipment to a general licensee under NRC's jurisdiction.

Currently, some Agreement State specific licensees send reports to the Comission voluntarily. There would be only negligible cost for these specific licensees to substitute the Comission's format. For the other-specific licensees from Agreement States, this subsection would impose a new cost, it is estimated on the basis of the NRC staff's understanding of the !

industry, that 6or each quarterly report there is an average of two staff hours ($80) spent and postage of $4. It is assumed that this cost would apply for one-third (30) of the specific licensees in Agreement States. The annual cost of the new subsection would then be estimatej at Cost (subsection a) = 30 reports / quarter x $84/ report x ,

4 quarters /yr = $10,080.

Based on quarterly transfer reports received by the Comission, approximately 25% of the specific licensees generate these transfer reports by

. computer. The proposed revisions would require some format revisions to the computer programs. It is estimated that it would require no more than two days (16 hours1.851852e-4 days 0.00444 hours 2.645503e-5 weeks 6.088e-6 months ) of staff effort per specific licensee to complete the revisions. _This is a one-time cost that would be characterized as an industry implementation cost. Approximately 38 vendors would expend about 16 hours1.851852e-4 days 0.00444 hours 2.645503e-5 weeks 6.088e-6 months l cach, or 608 hours0.00704 days 0.169 hours 0.00101 weeks 2.31344e-4 months at $40/hr for a total cost of $24,320.

1 4

l 21 !

subsection (d). This new subsection would require holders of specific :

licenses from Agreement States-to provide general licensee transferees with ;

copies of the general license contained in 10 CfR 31.5, instead of the i Agreeiwnt State license. The associated cost is small and is estimated to be !

1

$1.25 per shipment for stuffing envelopes and postage. The annual cost of l

this new subsection is then estimated to be :

Cost (subsection d)-= 12,000 shipments /yr x $1.25/ shipment = $15,000/yr !

- Thus the total cost to holders of specific licenses from Ag eement l

- States is estimated to be $25,080/yr. There is also an industry ;

) implementation cost estimated to be $24,320.

4.2.3 NRC Develppment and Implementation Costs ,

- NRC development costs are the costs of preparation pilor to l

. f implementation. They may include expenditures for research in support of the l

proposed regulatory action, publishing notices of rulemaking, holding public meetings, responding to public comments, and issuing a final rule. The

_- General License Survey, which is the research in support of the proposed regulatory action, has-already been performed and is therefore a sunk cost outside the scope of this analysis. Development costs within the scope of

- this analysis are the costs of: proceeding with a rulemaking. These are mainly= -

-s the costs of the effort of_ NRC professional staff members in the Office of Nuclear _ Materials Safety and Safeguards (NNSS) and in the Office of Nuclear f

Regulatory u toarch (RES) and of: publishing a notice of proposed rulemaking :

_.(NPRN);and the final rule'in the: Federal Register.

- i t

1

- .. ., ,an,-a +y .n,+,,- ,, .;.,.,.A,,-, ,...-.m. e,-- :n-- , ,,,..,.-.n,-,,,,...-~n - , - , - . , , , , . . , - .- ,o a

22 The proposed regulatory action is an amendment to existing regulations with annual costs to industry of less than $1 million spread over thousands of specific and general licensees. The action's preparation cost to NRC is

~

cstimated to require it total of two-thirds of a professional staff-year.

Based on Abstract 5.2 (revision 1) from Generic Cost Estimates, the estimated cost of one NRC professional staff is $72,000/ staff-yr. The component of NRC'S development costs due to staff effort, then. would be $48,000.

The proposed rule changes are relatively short and can be printed in two pages in the Federal Register. The preamble is also relatively short and would not require more than six pages. It is estimated that publication of the NPRM and the final rule would require a total of 16 pages. From Abstract 5.1, the cost ofn a page in the Federal Register is $600. Thus, the cost of publishing the NPRM and the final rule is estimated to be $9,600. The total NRC development costs, which would occur in a single year, are estimated to be approximately $58,000.

NRC implementation costs are those " front-end" costs necessary to effectuate the proposed action; they may arise from the necessity of developing procedures and aids, e.g., regulatory guides, to assist licensees in complying with the final action. The proposed revisions would affect specific licensees and general licensees for devices containing byproduct material. There are no implementation costs for NRC regarding general licensees. Ilowever, specific licensees would have to be informed of the regulatory changes. This would require the composition of a short regulatory aid kaown as an "information notice" and mailing the notice to the approximstely 150 specific licensees. It is estimated that this cost would

23 not exceed $4,000. The total NRC development and implementation costs are i then estimated to be $62,000.

4.2.4 NRC"inforcementCosts Enforcement costs are those costs incurred by NRC after it determines ,

that a licensee is not in compliance with the age.ti:y's regulations.

-Olscussion with HMSS indicates that the proposed regulatory action may result ,

in an increase in enforcement activities on the part of the NRC. Costs per i enforcement action would likely remain unchanged, but the number of enforcement actions might increase if the additional information available to the NRC indicates that general licensees have lost or abandoned devices or are handling the degices in an unsafe manner more frequently than currently seen. ,

The staff estimates that a one-time enforcement cost of 2 or 3 FTEs may be required to provide additional regulatory oversight in the form of providing copies of regulations and directions on the disposal of devices.

Based on an assumed annual enforcement rate of 1.5 percent for specific

licensees, it is estimated that about 600 general licensees might require enforcement actions per year. These actions would constitute continual NRC operating costs and could require from 4 to 6 FTEs annually depending upon thr

. complexity of the enforcement actions. Using the estimates provided in

" Generic Cost Estimates," NUREG/CR-4627, Rev. 1, for NRC labor rates, the techniques contained in the standard NRC regulatory analysis references, and '

assuming a 30 year time horizon, total estimates for NRC enforcement range from $4.8 million to $7.0 million, if one uses a 5 percent discount rate. If

- __ - - - - - ~ , - - _. - _ _ _ _ _ __ _

24 !

one uses the 10 percent discount rate, the costs could range from $3.'0 million !

- to $4.4 million. !

4 ;

[N.5=SummaryofCosts 1

-The costs of the proposed action will now be summarized in terms of. the l attributes defined in the Handbook. In accordance with the Guidelines, the i i

present value of annual costs will be estimated using a 10% real annual

- discount rate. To obtain a present value, the number of years over which the ;

e costs are incurred must be estimated. -These annual costs will continue to be q incurred as long as there is commerce in the subject devices, at current !

levels, with the proposed revisions in effect. This period will be assumed, ;

somewhat arbitrertly, to be 20 years. Then, with use of Table C.2 of the t Handbook, the present value of a cost'is its annual cost multiplied by 8.51. l Table 2 summarizes these costs, it should be r-ted that the enforcement cost ,

i identified in paragraph 4.2.4 above are not included in the summary since they ;

are not a direct cost of this rulemaking.

P J

t

?

-i

[

P t

eY-w-e-vem.-4y- r -

--,- eg gww en.re .ptd- y gv y,-n$--yy g * ,y- v --. .e, L- iopg. g 2-v =aemy-- ..--m-g-, y..egy 'h rsyw.mi-7 4 y. wm y- pe y.P -.+.-gse ppes.ip.nyw, rig m W F,- e.7r...ny .w(-e e L4e er-p.-e .c

i i

25 i TABLE 2 Summary of Costs to NRC and Industry of Proposed Changes ,

Cost ($1000)

Item Upfront Annual Pres,ent Value NRC development 58 NRC implementation 4 NRC operations 71 604 Industry operations

General licensee 433 3683 Specific licensee- 35 298 Industry implementation 24 4

O

26 5 DECISION RATIONALE It is recommended that the proposed action be adopted because it represents-a reasonable and cost-effective means for the Commission to fulfill its obligation to protect the public health and safety. It will ensure that general licensees comply with NRC regulations for devices containing byproduct

. material. The rationale for this recommendation follows.

The results of a survey conducted by the Commission indicated that there is noncompliance with the general license conditions contained in 10 CFR 31.5(c). Such noncompliance presents a risk to public health and safety by increasing the likelihood that such devices will be disposed of improperly.

Also, noncompliance regarding proper maintenance and servicing e.g., periodic leak tecting, presents an occupational risk. The General License Study revealed that a number of devices cannot be accounted for iv.d that a major reason for noncompliance is that employees of general licensees are unaware that, associated with the possession and use of these devices, there are license conditions that must be met.

The proposed regulatory action would establish a reasonable procedure to help ensure that general licensees are aware of the general license and that they do in fact comply with its conditions, it is estimated that adoption-of the proposed regulatory action would result in upfront development and implementation costs to the Commission of $62,000 and annuai costs to industry of $458,000 and-to the Commission of $71,000. There is also an industry implementation cost of $24,000.

Experience has provided information on the potential cost of disposing of devices improperly. Costs ranging from $50,000 to $2,200,000 have been n

s 27 incurred in cleanup and disposal of contamination in previous incidents, with additional costs incurred by the staff effort of regulatory agencies. It is not possible to estimate the reduction in the frequency of improperly disposed-of devices resulting in significant contamination that wout M attributable to the proposed action. However, if the frequency is r W ed by one such incident per year, the costs and benefits would be of comparable magnitude.

naced on the General Licensee Study, the Commission has knowledge that there is widespread ignorance among general licensees of the general license and its conditions. The Commission also his knowledge that a number of devices have been misplaced and are unaccotr.tud for. Similarly, the Commission is aware that improperly disposed-of devices containing byproduct material have caused contamination that could endanger the public health and safety and that have required expensive cleanup and disposal activities. The Commission, having knowledge of noncompliance with its regulations, has a responsibility to take reasonable steps to help ensure that licensees comply with its regulations. This responsibility is heightened when noncompilance puts the public health and safety at risk. The proposed action would provide a reasonable procedure to help ensure that general licensees are aware of the general license and comply with its conditions, Adoption of the proposal would thereby help the Commission fulfill its responsibility to protect public health and safety.

1

.. ________.i.-.-

. .. .=. . . -_ ~ . . . - . . --- ..- - _- . . . . _ . . . .

c.

28: (

6 IMPLEMENTATION

- The proposed regulatory action is not expected to present any significant-implementation problems. The computerized directory that would be required has already been implemented by the Commission. The only action

- needed.: for implementation is that the Commission develop and mail an information notice to specific licensees to inform them of their new <

responsibilities under the amended 10 CFR 31.6.

f Y-

?

4 W

4_'

4 6

e n- p- ,swg, * - , - - - =- ,--,a + ,cy w v- --

~

29 7 EFFECT ON SMALL ENTITIES As was discussed in Sec. 4.2.1 and 4.2.2 of this analysis, the proposed action would have-some economic impact on specific licensees and an general .

licensees of devices containing byproduct material. There are approximately-35,000 general licensees and approximately 150 specific licensees, many of

whom may be "small entities" within the meaning of the Regulatory Flexibility

. Act~(P.L.96-534). However, as will now be demonstrated, the economic impact

-on these entities would not be significant.

In Sec. 4.2.1 of this analysis, it was- estimated that the cost of responding to the Commission's initial verification request to general licensees would be $200,000/yr, it is estimated that there are approximately 80,000 devices transferred from specific licensees to general licensees under the Commission's jurisdiction per year. In Sec. 4.2.2, it was estimated that the cost to specific licensees of complying with the requirements of new subsections (a) and (d) of 10 CFR 31.6 would be $25,000/yr. It is very likely that the specific licensees would pass on this cost to the Commission's general licensees. The average cost to the Commission's general licensees of receiving transferred devices would thus be $225.000, or $2.81 per device.

The periodic verification requests impose an additional cost on general licensees. In Sec. 4.2.1, it was estimated that the annual cost of responding the the periodic verification requests is $233,340. It is estimated that

- there are approximately 400,000 devices in the possession of the Commission's general licensees. .The cost to-general licensees of periodic verification-requests-would'be approximately 50.60/ device /yr. The price of the devices ranges from $185 to_$250,000. However, many devices in commerce are density

. . - . - - ~ - .. . -. . - - . . . .--. - .- -_ . . . -.- ... . .-

P

- s. ,

(

30 i

orthiskness.gagescontainingbyproductmaterials'suchasamericiumthatcost from $1,000 to $10,000. The useful_ lifetime of such devices is limited to-3 to 10 yr by the durability of- their electronic' components. For devices with a 10-yr lifetime, the cost of the proposed action is estimated to be less than' l

-;$10, which is small in absolute terms and small in comparison to the initial.

cost of most devices. Therefore, the-proposed action would not have a significant economic impact on small entities. .

t 5

4 i

4 t

4 4

1 W

h 4

y e- w - i-=-- e +,e -

, .w . u . e. - cw,w- - - -

(. ]

AB.3 tH Pbg i

?

JUN 21 1990 MEMORANDUM FOR: Chief, Records and Reports Management Brenda J. Divisi6n Branch,' Shelton,'of Information Support Services, Office of Information Resources Management FROM:- Sher Bahadur, Chief, Regulation Development Branch,_ Division of Regulatory Applications, Office of Nuclear Regulatory Research

SUBJECT:

OMB CLEARANCE SUBMITTAL FOR THE PROPOSED RULE ENTITLED,

" REQUIREMENTS FOR THE POSSESSION OF INDUSTRIAL DEVICES

- CONTAINING BYPRODUCT MATERIAL" - 10 CFR PARTS 31 AND 32 Attached are a Federal Register Notice and a supporting statement for the OMB clearance submittal. . The OMB submittal is for the proposed rule entitled,

" Requirements for the Possession of Industrial Devices Containing Byproduct Material." The subject package has been previously reviewed by your staff and is being forwardgl to you for submittal to the Office of Management and Budget (OMB). The rulemaking package was submitted to the EDO for signature and for review by the Commission on June 1, 1990.

' NOTE FOR THE RECORD: The attached package was previously reviewed by Beth St. Mary of IRM in March and again in June 1990. Her comments and suggestions are included in this final package.

be Sher Bahadur, Chief Regulation Development Branch Division of Regulatory Applications Of_fice of Nuclear Regulatory Research Enclosures

1. Federal Register Notice

2. Supporting Statement

3. Proposed Rule-Distribution: [SHELTONME!'0]:

-subj-circ-chron-Reading. Files SBahadur- .

ADiPalo

. Mate

( .

Offe:.'D :RDB DD 4:RES D:DRA RES 2Name: JMate:cb. MF1tishman' SBahadur Date: '6/2)/90 6/tg/90 6h.l /90.

OFFICIAL RECORD COPY MOMO t p(n iSP(3

. , , s t

(f b 3 Lj- j JUN 21

U

- p- D rg- -.

k Distribution:-[3132OMB.FRN).

subj-circ-chron '*

Reading Files, PNorry, . IRM RSMith, OGC SBahadur MFleishman: ,

JNate: ' '

SHudson -

L

. 4 1

e N

r f

l

. 5

l

. i

< I i

l l

1 l

i i

Enclosure 1 Federal Register Notice e

s e

. g -- -

[7590-01]

NUCLEAR REGULATORY COMMISSION Documents Containing Reporting or Recordkeeping Requirements: Office of Management and Budget- ,

~ ~ ' '

(OMB) Review-AGENCY: Nuclear Regulatory Commission (NRC)-

ACTION:' Notice of the Office' of Management an6 Budget review of information collection.

SUMMARY

The Nuclear Regulatory-Commission (NRC) has recently submitted .

to' the Offjpe of Management and Budget (OMB) for review, the following proposal for the collection of information under the provisions:of the PaperworkReductionAct(44U.S.C. Chapter 35).

1. Type of submission, new, revision, or extension: Revision e 2. The title of the information collection: Requirements for Pos-session of Industrial Devices lContaining Byproduct Material -

10 CFR 31.5, 31.6, 32.51a, and 32.52.

~ 3. - .The form number.if applicable:-~Not Applicable 4-

4. ~ liow 'of ten < is the collectionL required: Collection'will continue to be-required.on a quarterly basis from specific licensees-who transfer

. devices to general licensees. In' addition, general licensees will be required to report initially.and then on a periodic basis. _

1

t.

4^

5. Who will be required or asked to report: Specific licensees (distributors)authorizedtodistributedevicesandgeneral licensees initially, and then on a periodic basis.

6. An estimate of the number of additional responses: Specific licensees - None, General Licensees - 31,667 annually.

7. An estimate of the total number of additional hours needed to complete the requirement or request: Specific Licensees -

608 hours0.00704 days 0.169 hours 0.00101 weeks 2.31344e-4 months (one time cost) and General Licensees - 12,226 hours0.00262 days 0.0628 hours 3.736772e-4 weeks 8.5993e-5 months .

8. The average burden per response is: General Licensees -

1 igitial response is 15 minutes and periodic respor.se is 50 minutes.

9. An indication of whether f.ection SE04(h), Public Law 96-511 applies: Not applicable

10. Abstract: The proposed rule wcult requite general licensees to respond to NRC with infurr.t. tion about radioactive material used under the general license provisions of Section 31.5 of 10 CTR Part 31. In addition, corresponding changes would be nede in the transfer reporting requirements imposed on persons authorized to distribute byproduct material in 10 CFR 31.5 and 32.52. These changes would require distributors of devices to use a uniform format or to provide all of the information required by the format on a clear and legible record when sulnntting their quarterly reports.

2

l

. .l n' \

Copies of the submittal may be inspected or obtained for a fee from the

-NRC Public Document Room, 2120 L Street NW., (Lower Level), Washington, DC.

Comments and questions can-be directed by mail to the OMB Reviewer:

Ronald Minsk, Paperwork Reduction Project (3150-0016 and 3150-0001).

Office of Information and Regulatory Affairs, NE08-3019, Office of Management and Budget Washington, DC 20503.

Commentscanalsobecommunicatedbytelephoneat(202)395-3084.

The NRC Clearance Officer is Brenda J. Shelton, (301) 492-8132.

Dated gt Bethesda, Maryland, this day of 1990.

For the Nuclear Regulatory Commission.

Patricia G. Norry, Designated Senior i Official for Information Resources Management l

3

l-i Copies of the submittal may be inspected or obtained for a fee from the NRC Public Document Robm, 2120 L Street NW., (Lower _ Level), Washington, DC, Cournents and questions can Le directta by mail to the OMB Reviews:r:

Ronald Minsk, Paperwork Reduction Project (3150-0016 and 3150-0001).

Office of Information and Regulatory Affairs, NE0B-3019, Office of Management and Budget Washington, DC 20503.

Comments can also be communicated by telephone at (202) 395-3084.

TheNRCClearanceOfficerisBrendaJ.Shelton,(301)492-8132.

Dated et Bethesda, Maryland, this day of 1990.

For the Nuclear Regulatory Consission.

Patricia G. horry, Designated Senior Officit.1 for Information Resources Management D RES'R0 RA RDB RA OGC IRM Name: JMate- SHudson M eishman SBahadur RSmith PNorry Date: 6/11/% 6/as/90 6/4t/90 6/2f/90 6/ /90 6/ /90 0FFICIAL RECORD COPY

\

4

4 4

,4 m Enclosure 2 Supporting Statement a

OMB SUPPORTING STATEMENT FOR PROPOSED RULES 10 CFR PARTS 31 AND 32 REQUIREMENTS FOR POSSESSION OF INDUSTRIAL DEVICES Description of the Information Collection The Nuclear Regulatory Commission is proposing to amend its regula-tions for assuring the safe use of byproduct material in certain gauges

-and other similar devices. The proposed changes, among other things, would require general licensees to respond to the NRC with information about radioactive material under the general license provisions Section 31.5 in 10 CFR Part 31, " General Domestic Licenses for Byproduct Materi-al." Corresponding changes would also be made in the transfer reporting requirements imposed on persons authorized to distribute byproduct mate-rial in 10 CFR 31.6, " General License to Install Devices Generally Licensed in Section 31.5" and 10 CFR 32.52, " Material Transfer Reports and Records." These changes would require distributors of devices to use a uniform format when submitting the quarterly transfer reports to NRC.

In addition, general licensees would be required to provide users of devices with written instructions and precautions to ensure that devices are used safely and are properly transferred.

A. Justification

1. [yed for the Collection of Information l$1959,theNRCamendeditsregulationstoprovideageneral license for the use of byproduct material conteined in certain luminous, measuring, gauging, and controlling devices producing light or emitting radiation. Under the conditions for a general license, certain persons may receive and use a device containing byproduct material if the device has been manufactured and distributed in accordance with the specifications contained in a specific license issued by the NRC or by an Agreement State. A specific license is issued upon a determination by a regulatory authority that the safety features of the device and the instruc-tions for safe operation are adequate.

The general licensee is required to comply with the safety instructions contained in or referenced on the label of the device and to have the testing or servicing of the device performed by the supplier or other specific licensee authorized to manufacture, install, or service such devices. A general licensed device is a

" black box" (i.e., the radioactive material is contained in a sealed source with a shielded device). The device is designed with inherent radiation safety features so that it can be used by a person without any radiation training or experience. Thus, the general license policy is a means of simplifying the specific license process whereby a case-by-case determination for the adequacy of. qualification is not necessary.

In the past, general licensees have. traditionally not been contacted on a regular basis because of the relatively small radiation risk of generally licensed devices compared to the risk of other specifically licensed installations.

y ;

i L

l !

During the past 30 years that devices have been used under the- -i'

- general license program, the operational history has been good.

These devices have survived fires and explosions on many occasions '

without a total loss of shielding. They have been damaped by molten steel and hit by construction vehicles with only minor ;osses in radiation shielding while maintaining the integrity of the source

-capsule.

~~

j There have been a number of occurrences involving generally--

licensed devices that suggest that better accounting for such devices may be beneficial.- For example, a gauge containing 340 mil 11 curies of krypton-85 was improperly disposed of by transferring-the device to a metal salvage yard that was not authorized to receive such a device. In another instance, a static eliminator bar i with 22.5 millicuries of americium-241 was sent to an unlicensed sanitary landfill. -Of course there have been other types of incidents involving NRC generally licensed devices including over-exposures, damaged devicss, leaking or contaminated sources, and ,

equipment malfunctions. However, loss of accountability romains the ,

most frequent incident and the predominant concern.

S Because of these occurrences, the NRC's Office of Nuclear Material Safety and Safeguards (NMSS) conducted a radiological risk assessment addressing storage of devices in warehouses, disposal in

,- scrap yards, incineration of waste, melting in a smelter, and 4 dispos 11 in a landfill. Included in the risk assessment was an incident at a steel company in 1983 (discussed in NUREG-1188 "The

- AuburnSteelCompanyRadioactiveContaminationIncident")whIch

probably represents a worst case scenario for generally licensed-gauging devices. Although individual doses were low and within guidelines for exposure of members of-the public, the clean up costs

- were in excess of two million dollars.

In consideration of both the risk assessment and incidents like

! those noted above, the NRC conducted a 3 year sampling (1984 thru

i- 1986)of F reports)generallicensees(takenfromthevendor'squarterly to determine whether there was an accounting problem with gauge users under general licenses, and if so, what remedial action might be necessary. The sampling was conducted both by telephone 4 calls;and site visits. The sampling revealed several areas-of concern about the use of radioactive material under the general license' provisions. On the basis of.the sampling, the NRC concluded that there is-1) inadequate accounting for these licensed devices '

l and, 2) T lack of awareness,of appropriate regulations on the part-L of the user. The NRC further concluded that these two problems can

be remedied by more frequent and timely contact between- the' general-licensee and the NRC.

The specific licensee-authorized to distribute such devices is required to submit material transfer reports and records to NRC identifying the person'or persons to whom such devices were trans-4 ferred _during the preceding calendar quarter. Under the proposed i revision, the distributor of the devices would be required to

-provide the NRC,-_using a prescribed format, some additional 1

2--

4 information about the general licensee to whom the devices were trans-ferred. After receipt of the quarterly transfer reports from the specific licensee, NRC would contact the general licensee who received the devices and ask them to verify in writing that they had purchased the devices containing byproduct material and that they understand the requirements of the general license. The general licensee would be required to respond to the NRC by letter and to verify the safety related parameters about the device and its location. A letter would also be sent to the general licensee periodically tnereatt#r'to verify that the general licensee still had the device and to remind them of their responsibilities relative to using and maintaining the device.

Any failure to respond or any reports of lost devices would initiate an innediate NRC follow-up action.

In order to correct the type of problems discussed above, the following revisions are proposed that will result in additional information collection requirements.

Section31.5(c)(11)isanewparagraphthatwouldbeadded that requires general licensees to provide specific information to-NRC. This information would include the following: complete name and address; specific information about the device received; name and teleahone number of the person responsible for controlling the use of tie device; address where the device is located or used; and whether the specific requirements or 31.5 (c) have been met. This inford tion will be used to validate and update the data provided by the specific licensee and will provide NRC with current data relative to ownership and location of devices.

Section 31.6 (d) would require specific licensees from Agreement States who hold a general license to install devices in non-Agreement States to supply a copy of the general license issued under 31.5 to each person who is responsible for the byproduct material and for ensuring compliance with the appropriate regulations and requirements.

This action insures that a person receiving the device is aware of their responsibilities for proper handling and reporting. Paragraph (e) would require that written instructions and precautions be provided to persons servicing the device to ensure its safe inctallation, operation, and servicing. Paragraph (f) would require a person performing routine installation / servicing / relocation of these devices to notify the appropriate NRC regional office at least 3 working days prior to the start of activities. These revisions provide a level of periodic inspection of those activities that intentionally place a worker in direct contact with the device or an unshielded radiation source.

Section 32.51a (c) would require specific licensees who hold a general license to provide users of devices with written instructions and precautions to ensure that the devicer are used safety. In addition,

these general licensees must provide any testing requirements, transfer and reporting requirements, and disposal options to such users.

, Section 32.52 (a) and (b) prescribes the format to be used when l submitting transfer reports to the NRC. The proposed format essentially standardizts the information currently provided about the general 3

a

(

licensee to whom the device was transfer. red. As such, no substantial additional information is being required.

2. Agency Use of the Information The information provided in the reports of the general licensees will validate and update information provided by the specific licensees relative to the transfer of devices. It will also serve to assure NRC that the general licensee' nas taken 'possession of the transferred material and is aware of his responsibilities as a general licensee.

3. Reduction o' Burden Through Information Technology There era no legal obstacles to reducing the burden associated with this information collection requirement through the use of information technology. In fact, the NRC encourages it. However, many licensees typically do not saintain records as required by the

- regulations on automated equipment. Therefore, the use of computers for reporting the requested information does not seem practical.

4. Effort to Identify Duplication There is no known duplication of information collection require-

' gnts within NRC relative to this requirement. The Information R5quirements Control Automated System (IRCAS) was searched and ,

_ no duplication was found.

5. Effort to Use Similar Information

' There is no similar information available to NRC,

6. Effort to Reduce Small Business Burden Because the majority of the specific and general licensees are small businesses, care was taken to require only the mininom amount

< of information needed in order to assure that the health and safety of the public is being protected. It is not possible to further reduce the burden on small businesses by reducing the information collected or the frequency of the collection.

7. Consequences of Less-Frequent Collection It is not possible to report less frequently. Should the

requested information not be reported on a periodic basis, the like-lihood of adequate protection of the health and safety of the public would be diminished.

8. Circumstances Which-Just'ify Variation From OMB Guidelines There is no variation from OMB guidelines.

I 4

9. Consultations Outside The imC The proposed rulemaking package wes reviewed by the Agreement States and their comments were incorporated to the maximum degree possible. It should be noted_that Agreement State licensees report to their states, and not directly to NRC. As a result, there will-be no duplication of effort.

10.- Confidentiality of Infunsior NRC provides no pledge of confidentiality for the collection of information, except for proprietary information that may be contained in the vendor's quarterly reports of transfer.

11. Justification For Sensitive Questions No sensitive information is being requested under these regulations.

12. Estimated Annual Cost To The Federal Government The total cost to the Federal Government to administer the proposed rule after it has been published and has become effective is shown below:

Sectkn 31.5 Verification of data from the quarterly reports would take 1820 hours0.0211 days 0.506 hours 0.00301 weeks 6.9251e-4 months (.091 hours0.00105 days 0.0253 hours 1.50463e-4 weeks 3.46255e-5 months x 20,000 shipments). The cost is

$167,440(1820 hours0.0211 days 0.506 hours 0.00301 weeks 6.9251e-4 months x $92.00 per hour).

Log in the general licensees verification response would take 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months (.025 hours2.893519e-4 days 0.00694 hours 4.133598e-5 weeks 9.5125e-6 months x 20,000 responses). The cost is $46,000 (500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months x $92.00 per hour).

Sending a periodic verification request to licensee and proccss the cost The response would is $124,476 (1353 take 1353 hours0.0157 days 0.376 hours 0.00224 weeks 5.148165e-4 months (.116 hours0.00134 days 0.0322 hours 1.917989e-4 weeks 4.4138e-5 months x 11 hours1.273148e-4 days 0.00306 hours 1.818783e-5 weeks 4.1855e-6 months x $92.0 Total Cost to Government on an Anouel Basis is 3673 hours0.0425 days 1.02 hours 0.00607 weeks 0.0014 months or

$337,916.

13. Estimate of Burden The estimate of burden for the licensees can be divided into three costs segments: the cost of corrpliance with Section 31.5, the cost of compliance with Section 31.6, and cost of compliance with Section 32.51a. There is ne rdditional cost burden for revisions tc

-Sectior. 32.52. .

'Section 31.5 Licensee response to the Commi nicr's quarterly verification request would take 5000 hours0.0579 days 1.389 hours 0.00827 weeks 0.0019 months (0.250 hrs x 20,000 responses).

The cost is $M0,000 (5000 hchrs x $92.00 per hour).

E

t l' .;

i.

Licensee response to periodic verification request would take 5834 hours0.0675 days 1.621 hours 0.00965 weeks 0.00222 months (.500 hrs x 11,667 responses). The cost is $536,728 (5834hoursx$92.00perhour).

The cost to the Licensees on an annual basis is 10,834 hours0.00965 days 0.232 hours 0.00138 weeks 3.17337e-4 months or $996,728.

Section 31.6 .

AgreementStateslicenseesnotificationtoNRCofquarterly).

transfers would take 996 hours0.0115 days 0.277 hours 0.00165 weeks 3.78978e-4 months (.083 hrs x 12,000 shipments The cost is $91,632 (996 hours0.0115 days 0.277 hours 0.00165 weeks 3.78978e-4 months x $92.00 per hour).

provide copy of general license to general licensees in A Stateswouldtake396 hours (.033hrsx12,000 shipments)greement. The cost is $36,432 (396 hours0.00458 days 0.11 hours 6.547619e-4 weeks 1.50678e-4 months x $92.00 per hour).

The cost to Licensees on an annual basis is 1392 hours0.0161 days 0.387 hours 0.0023 weeks 5.29656e-4 months or

$128,064.

Section 32.51a Specific Licensees revise computer systems to meet requested format. Only about 25% of specific licensees, approximately 38, now submit computer reports which would require changes. This wBuldtake608 hours (38licenseesx16 hrs). The cost is $55,936 (608hoursx$92.00perhour).

The cost to Licensees is 608 hours0.00704 days 0.169 hours 0.00101 weeks 2.31344e-4 months or $55,936.

Section 32.52 No additonal burden The total cost to licensees is 12,834 hours0.00965 days 0.232 hours 0.00138 weeks 3.17337e-4 months (10,834 + 1.392 + 608) or

$1,180,728.

14. Reasons For Change in Burden The burden shown in this proposed rulemaking package reflects an increase of 12,834 hours0.00965 days 0.232 hours 0.00138 weeks 3.17337e-4 months or $1,180,728 for material licensees (both general and specific licensees) over the current regulations.

The increase results from changes to the regulations that would require material licensees to verify that they have received devices from a specific licensee and that they understand their responsi-bilities in handling and using the devices. It should be noted that 608 hours0.00704 days 0.169 hours 0.00101 weeks 2.31344e-4 months of this total ($55,936) is a one time cost to revise computer systems and therefore is not an annual cost.

6

15. ,

Publication for Statistical Use Nor,e ' '

B. - Collections of Information Employing Statistical Methods Statistical methods are not used in the collection of information.

4 l

l M

7

, --~ . - . - ~ . . . . _ .. - . - . . . - - . - ~ - - . . - . -.

)

.l d .

_f

psh: Tl ;

V

. o- 93 ( j

-i

_ i

. hQ- .

i

."J oe s :

b

Attached :-is l your" commission paper along with.a: Copy of SECY-90~ }

175. -T he chanoes we would: like to- see in the paper are.as follows: :

%f 1 ~. . Include a discussion rela ting this- paper to SECY-90-175. .which

.is currently'before:the-Commission..

M-7 - 2 . -- -Include aidiscussion relating the BRC policy. What rances of t doses may be_- expected. from. generally .1icensed devices.-.And ;j accordingly, what-impacts might the BRC policy; have on. the numbers. -

of.such' devices out-~there?~

e c, P -- ?3. . Coordinate with OE on-the enforcement issue.- The Regulatory .i

- 9t A , Analysis discusses 600. but that number seems high and.could have *

.significant resource implications.

Please contact me if you have. Questions. ;

\'- e ge .

5

% g

., ~#

D ,,

p- */

{. *i 4-e

's =

4 4

4

~$

I.

'.-)

, a 9 .'

g.

t 4

?

O P

+e.. ,

. m w- . mew. eryem ,,.,w__, m.g-s , m.,v-.i-r,- ., ,, o m .54 .,n , wm -e r- m 3 y w-. wme

p .-

~

pp 06: kM

,s k m ak Geoeb.

"If' &h)'g b $. N Y f Y3 fjygg 8/3/90 OC COMMENT 5 DN DRAFT PAPER ON PRO,80$ED SENERAL LICENSE RULE CH/HBi!5 p0ge 3 Resources Sectient a The paper should cleat *:iy state whether the runs.ireen are inclueed in the draf t FY 1991-1995 Five Year Plan (FYPi. oE - NO s NkSS yn

- The paper should clear ly state what yeart si the i esourcats i arw resquired. B gg.i ninirm (\l 9 A. l ( AegTi O N hl, pS-NO It is unclear whether additional enfor.:ement resources 'DC h - N O arw resciuired by NMSS PC and the Megions, clue to these rule thenges beyond the NitBE one= time cost of 2 or 3 FTEs discussed on page :'3 of the Reglutatory Analysis (Enstesure 2) . NM85 to currently re-rseviewing the paper to remasosa their restniece requireemnts and to determine what's includest in the FYP.

- Th.is paragraph shoul:1 include informaition en r e scra r c e D' resquirements for all of ficers that are itientlenes on pagars N h#1 I-A 23 and 24 of kne Regu1 story Analysis (Enclosure 2). *stie og g'D 24 mentions , enforcement casts will be incuersed by 3Prie but these are not mentioned on page 3 of the paper. 3t e c. g o , \

is unclea- whether these are witMin SPA *a FYP.,

ik i %.\

bUC $0N1 l{ , Q i

4 I

e

([

r 1 A b 3 LH

- FEB 2 81931 pg '-

y e

1 Note to: John E. Glenn, Chief of the Medical and Commercial Use

- Safety Branch, Nuclear Material Safety and Safeguards

!tucrt A. Treby, ' Assistant General Counsel for Rulemaking and j- Fuel Cycle from: Sher Bahadur, Chief of the Regulation Development Branch, Office of Nuclear Regulatory Research

Subject:

PROPOSED RULEMAKING PACKAGE ON 10 CFR PART 31

.: Enclosed for your information is the proposed rulemaking package on 10 CFR Part 31 that has been revised to incorporate comments from the Executive Director for Operations (EDO).The package was originally submitted to the EDO in June 1990.

As you will note, the areas that have been modified include the purpose of and rationale for the proposed action. Please note that the actual language in the rule has essencially remained unchanged. Call me at 23775 if you have any-questions.

e Sher Bahadur, Chief Regulatory Applications Branch Office of Nuclear Regulatory Research

%s w "

Q,

[t r ij -

4 For: -The Commissioners From:' James M. Taylor, Executive Director for. Operations-

Subject:

PROPOSED AMENDMENTS TO 10 CFR PART 31 " GENERAL DOMESTIC LICENSES' FOR BYPRODUCT MATERIAL " AND 10 CFR PART-32,

" SPECIFIC DOMESTIC LICENSES-TO MANUFACTURE OR TRANS,FER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL"

~

Purpose:

To obtain Commission approval _for publication of a Federal-Register-notice for the proposed amendments.

Backaround: Between 1984 and 1986, the staff conducted a 3 year sampling both by telephone calls and site visits to determine the k

extent of compliance with the regulations which apply to the

_ general-licensees. Based on the sampling, the NMSS staff aconcludt) that there was a general lack of awareness of the appropriate regulations on the part of general: licensees and that-there was an inadequate handling and accounting for generally licensed devices. The impetus for the study in part was a number of incidents of improper use or disposition of

_ generally licensed devices. The staff believes these incidents were the result of-ignorance of the requirements and responsibilities for possession of these devices on the part of general licensees evidenced by the_ study. Although no significant public health and safety hazards resulted from these incidents, otherwise avoidable exposures did take place. Any unplanned release of radioactive material poses a potential

-threat to public health and safety, and causes unnecessary expense to-society. Between 1985 and 1990, such incidents cost an: average of.$750,000 per year. in cleaning up and disposing of contaminated material.-

On May 14,1990..the staff submitted a Commission Paper (SECY 90-175) which responded to the staff requirements memorandum (SRM) dated.0ctober 3,1989, concerning the

Contact:

Joseph J. Mate, RES -

492-3795~

e

L 10 The Commissioners 2 adtquacy of regulatory oversight of generally licensed materials. In SECY 90-175 the staff identified certain generally licensed devices that should be controlled through the specific licensing program. These devices are gamma gauges that of necessity are configured with a large air gap such that a worker could place a body part directly in the radiation beam.

The staff indicated its intent to initiate a separate rulemaking dealing with these devices.

The staff also identified in SECY 90-175 several types of devices which appear to be suitable for exemption from regulation. These devices include static eliminators containing krypton-85, beta backscatter devices, gas chromatographs containing nickel-63, x-ray fluorescence analyzers containing cadmium-109 and iron-95, and calibration and reference sources with small activities. Misuse or improper disposal of these devices would have a minor impact on public health and safety. Establishing exemptions for these devices could eliminate the need for up to 10,000 general licenses and 700 specific licenses. In accordance with Commission direction, the staff plans to initiate rulemaking under the Commission's BRC policy for devices that appear 4 suitable for exemptions.

With regard to the remaining larger group of devices for which neither exemption nor specific licensing appears appropriate, the staff stated that it intended to develop a rule change aimed at ensuring proper regulation of these generally licensed devices. The Commission concurred with the staff recommendations of SECY 90-175 and, by SRM dated August 13, 1990 (Enclosure 1), directed the staff to proceed with these rulemakings, and in particular, "to establish a registration and response system for general licensees ...." This rulemaking package has been developed in response to that SRM.

Discussion: There are approximately 35,000 general licensees who possess an estimated 400,000 devices containing byproduct material regulated under 10 CFR Parts 31 and 32. The proposed amendments (Enclosure 2) have been developed to ensure that the general licensees are aware of and understand the require-ments attendant to possession of these devices. This will be accompli;.ned through (1) an initial verification by the NRC staff of the information regarding the identification of and people responsible for the devica collected at the time at which the general licensee takes possession of the device, and (2) periodic follow-ups by the staff to remind general licensees l

I

______--_---._______._.___._.-__.____._.-.A_-._._____

L l a l-g The Commissioners 3 of their regulatory responsibilities and verify the currency of the information on possession and use that NRC has on these devices.

The staff believes that increased awareness and understanding of the regulations on the part of general licensees will increase the likelihood that they will comply with the Commission requirements for a generally licensed device.

Compliance with regulations will ensure that these devices are properly handled and accounted for and not inadvertently or improperly discarded, thereby reducing the potential for unnecessary radiation exposure to the-public.

Although, as discussed in SECY 90-175, the potential health and safety impact from the misuse or improper disposal of generally licensed devices was assessed to be small, the inadequate accounting of such devices evidenced in the 3 year sampling adds an uncertainty to the determination of the actual risk.

Through the proposed amendments, th( NRC should be able to gather information that would confirm that the risk is indeed low, and provide a basis for confidence that generally licensed devices are being handled and regulated in an appropriate

manner.

The proposed changes in Parts 31 and 32 are summarized as follows:

Section 31.2, " Terms and Conditions" - each general licensee would become subject to 10 CFR 30.9 which imposes requirements regarding the completeness and accuracy of information submitted to the Commission by licensees.

Section 31.5, "Certain Measuring, Gauging, or Controlling Devices" - all references to specific licenses issued by Agreement States which authorize distribution of devices to persons generally licensed by Agreement States would be deleted, and general licensees would be required to provide NRC with information about the devices and the people responsible for the device under provisions of a general license. This would include the name and telephane number of the person responsible for controlling the use c: the device, address where the device is located, and whether the specific requirements of Section 31.5 have been met.

Section 31.6, " General License to Distribute, Install, and Service Devices Generally Licensed in S 31.5" - removes th'e time limitation of 180 days placed on the specific licensee for distributing, installing, or servicing devices in non-Agreement States. In addition, it would impose information transfer and reporting requirements upon specific licensees

4.

The Commissioners 4 from an Agreement State who have a general license to distribute devices to general licensees in non-Agreement States. As a result of these modifications and a previous omission, the title of $ 31.6 is being modified to include the words " distribute and service." In addition, S 31.4, "Information Collection Requirements: OMB Approval," would be modified to include the information collection requirements added to $ 31.6 in the OMB approved list of information collection requirements for Part 31.

Section 32.51a, " Conditions of Licenses" - would require specific licensees to provide users of generally licensed devices with written: instructions, precautions, leak testing requirements, transfer and reporting requirements, and disposal options in order to ensure that devices are used safely and are properly transferred. .

Section 32.52, " Material Transfer of Reports and Records" -

would require the distributor of a device, a specific licensee, to use a prescribed new format, or to provide all of the information required by the format on a clear and legible

, record, when submitting a transfer report to the NRC. The new format requests more detailed and complete information about the general licensee to whom the device was transferred than currently requested in S 32.52.

Resources: A discussion of the development and implementation costs regarding the proposed rule is contained in the enclosed Regulatory Analysis on pages 22 and 23 (Enclosure 3). These one-time costs are nominal ($62,000) and are not considered to be a major factor in implementing the proposed rule. The second category of costs (on-going) are those that are incurred by NRC in processing the correspondence associated

( with the proposed requirements. This includes tracking the generally licensed devices and maintaining the records.

These costs amount to about $71,000 per year, or approximately 1.7 FTEs, for HMSS (see pages 14-20 of Enclosure 3). The final category of costs are on going enforcement costs. The enforcement costs are estimated to be about 0.5 FTE for NMSS and an additional 2 FTE: for the Office of Enforcement.

Additional resources woul6 also be needed in the Regional Offices on the ordt.' of 4 .-TEs. These costs assume that the current approach to enfo' cement actions is taken. However, the staff intends t: tv lop a more streamlined approach to enforcement actions for this class of licensee which would be much less resource intensive. The impact on the Office of Governmental and Public Affairs is less than 0.2 FTE. A discussion of these costs is contained on pages 23 to 25 of Enclosure 3. All of the resources identified above, except for

1-

[-

2

.The Commissioners 5 development and implementation cost (562,000), are expected to be needed starting in FY 1992 and are not currently in the Five-Year Plan (1991-1995) for the subject offices. -The rule

-is expected to be in place by early FY 1992.

Recommendations: Unless the staff is instructed to the contrary within 10 days from the date of this paper, the enclosed amendments to 10 CFR Parts 31 and 32 will be issued as a proposed rule.

Coordination: .The Office of Governmental and Public Affairs concurs with the contents of this paper. The Office cf the General Counsel has no legal objection.

James M. Taylor Executive Director for Operations

Enclosure:

1. Staff Requirements Memo (August If, 1990)

2. Federal Register Notice

3. Draft Regulatory Analysis

, 4. Congressional Letters e

The Commissioners 5 cave'opment and implementation cost ($62,000), are expected to b4 6.eedad starting in FY 1992 and are not currently in the F .ve-Year Plan (1991-1995) for the subject offices. The rule is expected to be in place by early FY 13'2.

Recommendationp: Unless the staff is instructed to the contrary within 10 days from the date of this paper, the enclosed amendments to 10 CFR Parts 31 and 32 will bs issued as a proposed rule.

~

Coordination: The Office of Governmental and Public Affairs concurs with the contents of this paper. The Office of the General Counsel has no legal objection.

James M. Taylor Executive Diree'or for Operations

Enclosure:

1. Staff Requirements Memo (Augustif,1990)

2. Federal Register Notice

3. Draft Regulatory Analysis

4. Congressional letters

SEE PREVIOUS CONCURRENCE Offe: RDB:DRA:RES RDB:0RA:RES RDB:0RA;RES DD:DRA:RES DRA:RES DD/GRI:RES 0:RES Name: "JMate:cb *MFleishman *SBahadur .

Costanti *BMorris *CHeltemes *EsBec,kjord Date: 5/30/90 5/30/90 5/30/90 5/30/90 5/30/90 6/01/90 6/01/90 Offe: GC:0GC D:0E 0:NMSS E00 GPA Name: *WParler "JLieberman *RDernero lor *SSchwartz Date: 5/30/90 7/26/90 5/21/90 JTay/90

/ 8/10/90 0FFICIAL RECORD COPY

.~_ . - - - - . . - - - . - - . ~ . - - - - - .

I l

1hc Commissioners 5 cost ($62,000) are expected to be needed starting in TY 1992 l and are not cur-rently in th / rive Year Plan (1991-1995) for the subject offices. The rul it expected to b, in place hy mid TY 1991.

~

Recommendations: Unless lhe staff is instructed to the contrary within 10 days '

from the da(e of this pher, the enclosed amendments to 10 CFR

' Parts 31 and' 2 will b issued as a proposed rule. ,

Coordination: The Office of G rnmental and Public Affairs concurs with the contents of thig paper. The Office of General Counsel hasnolegalobjecion.

ames M. Taylor cutive Director f Operations

Enclosure:

Proposed Rulemaking Packag P

t

SEE PREVIOUS CONCURRENCE Offet RDB:0RA:RES RDB:DRA:RES RDB:DRA:RES DD:DRA:RES DRA:RES DD/GRI:RES D:RES Namet cJMate:cb *MFleishman *SBahadur *Costanzi *BMorris *CHeltemes

ESBeckjord l Dates- 5/30/90 5/30/90 5/30/90 5/30/90. 5/30/90 6/01/90 6/01/90 Offet 'BC:0GC D:0Es D:NMSS EDO G Raset *WParler JLieberman *RBernero JTaylor j'(riz Dates 5/30/90 7/Ab/90 5/21/90 / /90 s/t /90 OfflCIAL RECORD OPY

i

, t The Connissioners 5 l

1 of Enclosure 2. The final category of sts are enforcement costs. The enforcement costs, however are higher and are

. estimated to be on the order of 2 to FTE(one-time)for :

NMS$ and an additional 2 to 3 FTE f OE(on-going). A discussion of these costs is cont ned on pages 23 and 24 of _

the regulatory analysis (Enclosu 2). ;

Recommendations: Unless the staff is instructe to the contrary within 10 days from the date of this paper, he enclosed amendments to 10 CFR Parts 31 and 32 will be iss ed as a proposed rule.

Coordination: -

The Offices of Governmen 1 and Public Affairs, Nuclear Material Safety and Saf guards, Enforcement, and .

Administration concur n these amendments. The Office of General Counsel has legal objection.

James M. Taylor Executive Director for Operations

Enclosure:

Proposed Rulemaking Package o

SEE PREVIOUS CONCURRENCE Offer ROB:DRA:RES RDB:DRA:RES RDB:DRA:RES DD:DRA:RES DRA:RES DD/GRI:RES D:RES iMamet OJMate:cb *MFleishman *SBahadur- *Costanzi

Bilorris - ' *CHeltemes *ESBeckjord Dates- 5/30/90 5/ 5/30/90 5/30/90 5/30/90 6/01/90 6/01/90' Offet GC:0GC 0 :NMSS EDO

^Mame *WParler / JLi

0 *RBernero JTaylor Dates 5/30/90' 7$t /90 5/21/90 / /90 0FFICIAL RECORD COPY

-v--

rr-w 6 -w a

a TheCNmmssioners 4 4

Coordination: 4he Offices Governmental 7:.d Public Affairs, Nuclear Material 5)fety and Safeguards, and Administration' concur in these amendments. The Office of General Courr.el has no legal objection. -

James M. Taylor

=-Executive Director

'f,or Operations N ,

Enclosure:

Proposed Rulemaking Package

\

N,,N '

N

'N 4

s s

\

- MA m 1 .

Offet DRA:RES Rd A:RES (Rd NRA RES R :RE

.RES D MS D:RE Namer te:cb MF1 shman SBahadur Cort 8nzi N (r C temes JSBeckjord Date I /n /90 s /$$/90 5/p/90 #1d/90 O/90 Q /90- 4// /90 Offet GC:0GC D:NMSS EDO Name t. WParler RBernero JTaylor <

Date: S / 30/90 . F/AI/90 / /90 4tt 5EE OFFICIAL. RECORD COPY H tvt tu n P hC. g4 P A g gg

i

.- l l

The Commissioners 4 coordination: The Offices Govern ntal and Public Affairs,-Nuclear Material -

Safety and Safegu ds, and Administration concur in these !

amendments. The ffice of General Counsel has no legal objection. l t

James M. Taylor -

Executive Director for Operations ;

Enclosure:

Proposed Rulemaking Pa age 4

Offer RD8:DRA:RES RDB:DRA:RES RDB:DRA:RES RDB:DRA:RES DD:DRA:RES DRA:RES D:RES Namat JMate:cb MFleishman SBahadur Costanzi BMorris CHeltemes ESBeckjord cates. /90. / /90 / /90 .

/ /90 / /90 / /90 / /90 Offet :0 Dh5%b EO

-Name: arler RBernero : JTaylor

. Dater- /p/90 f/y/90 / /90 0FFICIAL RECORD COPY

' ' * %, UNITED STATES

/* ,

/ n NUCLEAR REGULATORY COMMISSION '

[ )L , WWHNG T ON, D. C. 20%6 s

+..... MAY tf e MEMORADUM FORT Eric Beckjord Director Office of Nuclear P:;.htery Research TROM: Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards StfBJECT: PROPOSED RULEMAKING FOR POSSEt.i10N OF INDUSTRIAL DEYlCES

. 10 CFR PARIS 31 and 32 ;

Your March 14, 1990 memorandum requested Office concurrence on the proposed rule. By memorandum dated March 30, 1990, we responded with several recomended changes, mostly editorial and requested an opportunity to renew the final package before it was sent forward.

-Our staff has met and resolved our concerns. By note dated April 23, 1990, Mr. Joseph Mate of your staff forwarded a revised proposed rulemaking packaged and requested finah Office concurrence. We concur that the subject document should be published for public comments. A few comments are in the enclosed markup, s %

Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards

Enclosure:

As stated

(. 4 .

___ ._._..._.__.__.m.. ___ . _ . _ _. . _ ___ _... _ _ __ _ . _ . _ _ _ _ _ _ _ _ _ _ . __,

b i

t 4 L s

f .

1 i

Document Names !

PARTS 31 32 CP i i

I Requestor's ID: i 90NSBY !

r i

t Author's Name:- i NATE, J. l t

i Document Co w .a .~* * .

i l bonsby 2/26/91-CP FOR PARTS 31/32 INDUSTRIAL DEVICES l l

F f

?

i

?

e h

8 i

v

< .t

?

I k

i e

h i

e

+

4 1

?

t 4

4 E

1 a 3 e ?

i 5

.j

.j i

-.{:

~ . _ u-_ , - , . _ . . . . - - -- . - . _ . - - - . _ . _ - , .

.- . 2

ML20217L035

Contents

Text

Dear Mr. Chairman:

Enclosure:

Dear Mr. Chairman:

Dear Mr. Chairman:

Enclosure:

Dear Mr. Chairman:

Enclosure:

Dear Mr. Chairman:

Enclosure:

Subject:

Background:

Contact:

Enclosure:

Enclosure:

Enclosure:

Enclosure:

SUMMARY

Background

Subject:

1.1 BACKGROUND

SUBJECT:

SUMMARY

Subject:

Subject:

Purpose:

Contact:

Enclosure:

Enclosure:

Enclosure:

Enclosure:

Enclosure:

Enclosure:

Enclosure:

Navigation menu

ML20217L035

Text

Dear Mr. Chairman:

Enclosure:

Dear Mr. Chairman:

Dear Mr. Chairman:

Enclosure:

Dear Mr. Chairman:

Enclosure:

Dear Mr. Chairman:

Enclosure:

Subject:

Background:

Contact:

Enclosure:

Enclosure:

Enclosure:

Enclosure:

SUMMARY

Background

Subject:

1.1 BACKGROUND

SUBJECT:

SUMMARY

Subject:

Subject:

Purpose:

Contact:

Enclosure:

Enclosure:

Enclosure:

Enclosure:

Enclosure:

Enclosure:

Enclosure:

Navigation menu

Search