ML20207T145

Recommends That Further Work on RES Review of Ongoing RES-sponsored Rulemaking Re Revs to 10CFR30,32,40 & 70 Concerning Licensing of Sources & Devices Be Terminated. Draft 840411 Proposed Rule Encl

ML20207T145
Person / Time
Issue date:	05/15/1985
From:	Minogue R NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
Shared Package
ML20205D544	List: ML20205D540 ML20205H439 ML20206R668 ML20206T160 ML20207A130 ML20207S558 ML20207S637 ML20207S669 ML20207S695 ML20207S845 ML20207S866 ML20207S892 ML20207S910 ML20207S926 ML20207S935 ML20207S947 ML20207S955 ML20207S965 ML20207T123 ML20207T134 ML20207T142 ML20207T145
References
FRN-52FR2540, RULE-PR-30, RULE-PR-32 AB34-1-28, AB34-2-42, NUDOCS 8703230250
Download: ML20207T145 (51)

Text

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• RE5 Central Files l RAMRB r/f Subject Circ /Chron e p l

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!' MEMORANDUM FOR: William J. Dircks Dross Executive Director for Operations RMinogue l FROM: Robert B. Minogue, Director l Office of Nuclear Regulatory Research t

SUBJECT:

CONTROL 0F NRC RULEMAKING: RES REVIEW 0F ONG0ING RES-SPONSORED RULEMAKING: REVISIONS TO 10 CFR 30, 32, l l i.

j 40 and 70: LICENSING OF SOURCES AND DEVICES 7 ,

L I Based on our reassessment of the subject rulemaking. RES recausends that

(

I further work on this rule, in its present fom, be teminated. This review has

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g  !

l L been coordinated with the Office of Nuclear Material Safety and Safeguards, who  !

. F i E 4 concurs with this recommendation.

The basis for this roccamendation is as follows:

r

! l o The proposed rulemaking would propose to replace a voluntary system.

4 r No abuses of the voluntary system (which has been in effect for many

I j years). have been cited to support the need for this proposed action.

r .

E o The principal benefits of rulemaking are administrative in nature and do not flow to the licensees impacted by this proposed E .

rule; this action would seem to increase the regulatory burden ,

r

!, by requiring both the manufacturer and the user of the sealed sources -

or devices to be licensed rather than the present method of just 2 Iicensing the user.

1 - r L o Based on the draft Regulatory Analysis, the net cost impact

, i of these proposed rule changes are inconclusive, but appears

- r -

to be modest.  ;

I l b  :' o NMS$ is presently pursuing the development of an alternative

! apprnach to modifying the licensing process for sealed sources and ,

e devices which would be less onerous on the industry and more effective in rehctna the NRC workloed. We anticipate that a new L rulemaking action will be proposed by NMSS in the near  !

future.

The complete RES review package has been sent to OED0 (Attn: DEDROGR) and to I the Director, NMSS 0703230200 070304 PDR PH i 30 D2FR2040 PDR ,

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' Robert B. Minogue. Director

"' Office of Nuclear Regulatory Research

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,,,,,,, nM ss /o/ 2/, 8 d Licensing of Sources and Devices CFR CITATION:

10 CFR 30; 10 CFR 32; 10 CFR 40; 10 CFR 70 ABSTRACT:

The proposed rule would require manufacturers or distributors of sealed sources or devices containing sealed sources to obtain a license from the NRC prior to the initial transfer of the sealed t sources or devices to specific licensees. The rule would also k require' manufacturers or distributors of sealed sources or .

E devices to provide the NRC with information on such products r relating to design, manufacture, testing, operation, safety and hazards as a condition for obtaining a license. If the proposed L

requirements were applierd to the 800 material license E applications and amendments reviewed in 1982 as a statistical t base, total costs to suppliers would rise irom 5148,025 under the i current voluntary program to $152,950. At the same time, the

! proposed rule would eliminate the $48,000 cost to material

[ licensees of preparing 800 license amendments.

[

NRC plans to ^___l.--__ M - r-l-- '2 r- - ' develop an alternative means to modify the licensing process for sealed.

P sources and devices that would be less costly to the industry and 1 more offactive in reducing the NRC workload.

7 TIMETABLEt _f f[

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c (,[*o /F 7 g Final Action 9t/' 00K LEGAL AUTHORITtt 42 USC 2111; 42 USC 2201; 42 USC 2071; 42 USC 2092 I EFFECTS ON SMALL BUSINESS AND OTHER ENTITIES: Yes b AGENCY CONTACT f Donald R. Hopkins Nuclear Regulatory Commission

Office of Nuclear Regulatory Research E Washington, DC 20555 301 443-7678 A de af~ $,," %

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, [7590-01) p*,'h" NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30, 32, 40, and 70 Licensing of Sources and Devices AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

The Nuclear Regulatory Commission is considering amending its

SUMMARY

regulations to require suppliers of sources co'ntaining radioactive '

material or devices which contain sources as part of the device to submit 1

design, construction, quality control, and other information to enable the Commission to conduct generic safety reviews of these sources and devices. The proposed amendments would require generic safety reviews

} ' (as opposed to custom review for specific applications) for all sources The proposed and devices which will be distributed to specific licensees. e d -

amendments will create a formal source and device safety review process j

in place of the current voluntary program thereby providing a well defined regulatory authority applicable to both supplier and license 6

applicant.

g 5

Comments should be submitted on or before DATES:

E Comments received after this date will be considered if it is practica f

ik to do so, but assurance of consideration cannot be given except as to comments received on or before that date. .

1 Submit comments on the proposed rule or the supportirg ,

ADDRESSES:

4 regulatory analysis to the Secretary of the Commission, Nuclea l

i i 1 FRN 10 CFR 30 32 40 70 f 04/11/84 I

[7590-01]

... .s i

tory Commission, Washington, DC 20555, Attention: Docketing and Service Branch. Single copies of the regulatory analysis may be obtained on riquest from the contact identified below. Copies of the regulatory analysis and of ecmments received by the Commission may be examined in the Commission's Public Document Room at 1717 H Street NW., Washington, DC.

- FOR FURTHER INFORMATION CONTACT: Donald O. Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC E

20555,tilephone(301)443-7891.

SUPPLEMENTARY INFORMATION:

L

Background

Applicants for specific material licenses submitted under 10 CFR Parts 30, 40, and 70 for use of sources containing radioactive material C

E or devices containing such sources, must specify in the license appli-r I cation the manufacturer and the model number of the source or device to r '

be used. Approval of such license applications is given only after a safety evaluation of the source or oevice has been performed by the NRC or Agreement States' licensing staffs.

i In the absence of specific regulatory requirements applicable to both the supplier and the licensee applicant, the licensing staffs, in an effort to expedite the application review process, have encouraged suppliers of such sour:es and devices to provide design, construction, quality control, and other information needed to perform the safety evalu-ations before the customer (licensee applicant) has a need for these item-04/11/84 2 FRN 10 CFR 30 32 40 70

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i.

This voluntay program, which has been in use for a number of years, was intended to develop a list of "off-the-shelf" sources and devices for which generic safety reviews had been completed before the customer had a need for them.

Because there is no regulatory requirement, a number of problems exist with the present voluntary system. These include misunderstanding 4

by suppliers of the requirements of the voluntary system, failure to

' submit all the information needed for generic safety reviews, and sub-I mission of inadequate quality assurance prograas. These cause unneces-sary burdens and delays for the licensee applicart who is often forced to 6 act as a conduit funneling the required information from the supplier to r

L the NRC or to the Agreement States.

• Sometimes suppliers provide only enough information for a " custom L

review" for a specific application of a specific customer. One result of I thesenongeretic(customorspecific)reviewsisthatsubsequentusersof L

E the same item (which would be an "off-the-shelf" item if a generic safety L

review had been perfomed) aften suffer licensing delays and additional 6

? ,

costs for ad,ditional safety reviews required to assess the safety of the

[

j k item for their particular operation. In addition, costs and delays are r

i often suffered by current users of such items when they wish to change from one model source or device to accommodate changes in their opera-f I tions. The additional safety reviews resulting from current practices i E require some 800 amendments to NRC licenses annually, and constitute a I

considerable burden to the materials licensing staffs and to the i

licensees themselves.

In addition, although 99% of all suppliers of sources and devices i

are NRC licensees, the present voluntary program allows the NRC no 3 FRN 10 CFR 30 32 40 70 04/11/84 i

' [7590-01]

k authority over the quality assurance program of the supplier. The pro-i posed rule however would provide a specific regulatory requirement for the submission of such a quality assurance program as part of the license application to distribute sources and devices. S'uch a regulatory require-  ;

^

4 ment should provide a mechanism for alerting the licensing staffs of c

possible safety problems associated with the sources or devices.

4

The NRC feels that replacement of the current voluntary program with well defined regulatory requirements will not place any additional burden on suppliers of sources and devices since they are already providing  ;

f certain information directly or through their customers (licensee

) applicants). The institution of a regulatory basis for providing this 4

information will allow increased flexibility in the types of sources and O

devices which licensees may possess and use, will eliminate the necessity l for licensae applicants having to provide complete information on each i

source and device they plan to use, and will eliminate the need for 800 license amendments per year.

c i The NRC is proposing to amend its regulations by adding new sections T

C to 10 CFR Parts 30, 32, 40, and 70 to require suppliers of sources and o devices containing sources which will be distributed to specific licensees to submit design, construction, prototype testing, quality b control, and other information as needed for review of such sources and devices.

[

I The establishment of the proposed amendments would also provide for classification of devices containing sources according to the uses intended for the devices. A licensee would be permitted to possess and i

(

use any approved device containing a source within a specific category i without the need for a license amendment.

f 4 FRN 10 CFR 30 32 40 70 04/11/84 1,  !

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NO ENVIRONMENTAL IMPACT This proposed rule is non-substantive and insignificant from the standpoint of environmental impact. Therefore, neither an environmental impact statement nor an environmental impact appraisal and negative declaration are required for this proposed rule (10 CFR 51.5(d)(3)).

PAPERWORK REDUCTION ACT STATEMENT f' ~

I

' This proposed rule amends informatiin collection requirements that are subject to the Paperwork Reduction Act :f 1980 (44 U.S.C. 3501 et

{

E seq.). This rule has been submitted to the Office of Management and i

g Budget for review and approval of the paperwork requirements.

t a

REGUI.ATORY ANALYSIS e

e L

[

The Commission has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and benefits of the I

alternatives considered by the Commission. The draft analysis is avail-l able for inspection in the NRC Public Document Room, 1717 H Street NW.,

L Washington, DC. Single copies of the analysis may be obtained from j Donald O. Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear k Regulatory Commission, Washington, DC, telephone (301) 443-7891.

The Commission requests public comment on the draft regulatory analysis. Comments on the draft analysis may be submitted to the NRC as indicated under the ADDRESSES heading.

04/11/84 5 FRN 10 CFR 30 32 40 70

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l REGULATORY FLEXIBILITY CERTIFICATION On the basis of information available to it at this stage of the rulemaking proceeding and in accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission hereby certifies that this rule will not, if promulgated, have a significant economic impact on a sign **1 cant number of small entities. The proposed rule affects about 290 rappliers of sources and devices, most of whom qualify as small

[

business entities. In order to obtain a safety evaluation of their F

i products prior to distribution to their customers (NRC and Agreement t

State licensees), these suppliers are required to submit design and other

[

required information to the licensing staffs and are assessed fees for i safety reviews as provided in 10 CFR 170.31.

The approximately 290 suppliers are assessed fees of $350 for a f

h . generic source safety review and $175 for a custem source safety review,

$1600 for a generic device safety review and $800 for a custom device t

safety review. In addition, up to 5 drawings and 10 pages of text are

(

I required, adding an additional 5240 for supplier staff time in assembling whiswM thegforeachofthereviews. The resulting costs are then $590 and 5415 for source reviews and 51840 and $1040 for device reviews.

g During 1982 there were 50 generic source safety reviews performed at h

a cost of $29,500 and 19 custom source reviews performed at a cost of t 57885. During this same period there were 59 generic device safety reviews performed at a cost of $108,560 and 2 custom device reviews per-formed at a cost of 52080. The total costs to the 290 suppliers during this period were 5148,025. Also during 1982 there were some 800 license 04/11/84 6 FRN 10 CFR 30 32 40 70

[7590-01]

amendments at 560 per amendment, resulting in costs to Itcensees of

$48,000 and an overall cost of $196,025.

The proposed rule would eitminate custom reviews and require source and device suppliers to obtain generic safety reviews for all of their products prior to distribution to their customers. If this rule were applied to the 1982 reviews, the total costs to suppliers would rise to

$152,950, an increase of 3%. At the same time the proposed rule would eliminate the need for the 800 Itcense amendments costing 548,000, resulting in an overall cost reduction of some 25%. The costs to individual suppliers would depend upon the number of items submitted for r,

safety review.

I The proposed rule should have only a minor econcate impact on the r

L majority of suppliers since, although the fees are made mandatory under I the rule, most suppliers have been paying these fees under the voluntary program. The small increase in fees to the suppliers, as indicated

[ above, will be offset by a larger decrease in fees to Itcensees due to i

~ the reduction in the number of license amendments required annually.

L F

I LIST OF SUBJECTS IN 10 CFR PART 30, 32, 40 AND 70 4

L y pART 30 t

I l

L Byproduct material, Government contracts Intergovernmental relations Isotopes, Nuclear materials, Penalty, Radiation protection, Reporting and Recordkeeping requirements.

(

7 FRN 10 CFR 30 32 40 70 04/11/84 i

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[7590-01]

PART 32 Byproduct material, Labeling, Nuclear materials, Penalty, Radiation protection, Reporting and Recordkeeping requirements.

PART 40 Government contracts Hazardous materials-transportation, Nuclear h

Y materials, Penalty, Reporting and Recordkeeping requirements, Source k material, Uranium.

I PART 70 F

-- Hazard,ous materials-transportation, Nuclear materials, Packaging and containers, Penalty, Radiation protection, Reporting and Recordkeeping g

requirements, Scientific equipment, Security measures, Special nuclear material.

f For the reasons set out in the preamble and under the authority of c.

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 adop* the f following amendments to 10 CFR Parts 30, 32, 40, and 70.

L.

t- 04/11/84 8 FRN 10 CFR 30 32 40 70

[7590-01]

PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MnTERIAL

1. The authority citation for Part 30 is revised to read as follows:-

AUTHORITY: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 441, as amended (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2316, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244,1246(42U.S.C.5841,5842,5846).

Sec. 30.7 also issued unoer Pub. L.95-601, sec. 10, 92 Stat.

c 2951(42U.S.C.5851). Sec. 30.34(b) also issued under sec. 184, 68 t

Stat.954,asamended(42U.S.C.2234). Sec. 30.61 also issued under I

sec.187,68 Stat.955(42U.S.C.2237).

j For purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);

I: 55 30.3, 30.34(b) and (c), 30.41(a) and (c) and 30.53 are issued under sec. 161b. 68 Stat. 944, as amended (42 U.S.C. 2201(b)); and 55 30.36, 30.51,30.52,30.55and30.56(b)and(c)areissuedundersec.161o,68 Stat. 950, as namnded (42 U.S.C. 2201(o)).

2. Section 5 30.35 is added to read as follows:

- 5 30.35 Sources and devices.

(a) Subject to the provisions of paragraph (c) of this section, an appitcation for a specific license to use any type of source or any

(

l device containing sources for use or uses specified in groups I to VI

• inclusive of 5 30.72, will be approved for all the uses specified in the application if --

(1) The applicant satisfies the general requirements of 5 30.33; i

04/11/94 9 FRN 10 CFR 30 32 40 70

[7590-01]

i The applicant has adequate experience in the use or uses of (2) byproduct material specified in the groups listed in 5 30.72; i

(3) The applicant's radiation detection and measuring instrumenta-tion is adequate for tht specific uses applied for from the list of uses described in 5 30.72; and (4) The applicant's radiation safety procedures are adequate for the spacific uses applied for from the list of uses described in 6 30.72.

(b) An appitcation for a specific license to possess and use a -

device containing a source which has not been specifically approved for

' inclusion in one of the groups in Section 30.72 Schedule C will be approved if the applicant satisfies the general requirements in Section 30.33 of this chapter and satisfies the requirements in Section 32.120 or equivalent regulations of an Agreement State.

(c) The source or device has been approved under,10 CFR 32.120 < r

• the equivalent regulations of an Agreement State.

4 r

3. A new I 30.72 is added to read as follows:

Schedule C - Groues of devices containino sources of byproduct

$ 30.72 I

material and maximum allowed activities ner device.

1 (a) GROUP I - Fixed (normanently mounted) cauces.

l (1) Tvoe 1 - Density Measurement, The use of sources contained in gauging devices manufactured and f

distributed in accordance with a specific license issued according to the provisions of 10 CFR 32.120. These devices are designed to measure i density of materials in fixed installations, f

i 10 FRN 10 CFR 30 32 40 70 04/11/84 t

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Maximum Activity Isotope Cs-137 10 curies Co-60 1 curie An-241 1 curie (2) Tvoe 2 - Level measurement.

The use of sources contained in gauging devices manufactured and distributed in accordance with a specific license issued according to the provisions of 10 CFR 32.120. These devices ars designed to measure height of ft11 or interface location of materials in fixed installations.

Maximum Activity ,

Isotope 1

Cs-137 10 curies -

Co-60 250 stD icuries l

(3) Tvoo 3 - Thickness measurement and control.

The use of sources contained in gauging devices manufactured and i

distributed in accordance with a specific license issued according to the provisions of 10 CFR 32.120. These devices are designed for use in fixed installations to measure or control thickness of materials.

l Maximum Activity

' Isotope

$r-90 300 minicuries l

Cs-137 10 curies 1

Kr-85 1500 militcuries i

Co-60 1 millicurie i

l Pm-147 5 millicuries l

T1-204 250 millicuries I Ru-106 30 millicuries i

I 11 FRN 10 CFR 30 32 40 70 04/11/84 i r

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(4) Type 4 l- Moisture measurement.

TheuseofOourcescontainedingaugingdevicesmanufacturedand distributed in accordance with a specific license issued according to the i provisions of 10 CFR 32.120. These devices are designed to measure i moisture content of materials in fixed industrial installations.

1 Maximum Activity

,l Isotage -

Am-241:Be 1 curie i

i (b) GFOUP II - Analytical instruments.

(1) Type 1 - Gas chromatocraohs and aerosol detectors.

The use of sources contained in gauging devices manufactured and distributed in accordance with a specific license issued according to the provisions of 10 CFR 32.120. These devices are designed to determine quantitatsve and qualitative chemical composition of materials by gas l

chromatography in laboratory or industrial environments.

Isotope Maximum Activity I H-3 300 millicuries i

Ni-63 40 mil 11 curies

! Am-241 60 microcuries (2) Type 2 - X-ray fluorescence analysis devices.

I The use of sources contained in gauging devices manufactured and i ,

distributed in accordance with a specific license issued according to the These devices are designed to determine elemental provisions of 5 32.120.

' composition of materials using the X-ray fluorescence technique in both i

4 laboratory and field conditions.

1 i

i i 12 FRN 10 CFR 30 32 40 70 04/11/84 I

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[7590-013 M_aximum Activity

-Isotopat 100 millicuries Cd-109 125 millicuries Fe-55 200 millicuries Cm-244 100 millicuries An-241 100 millicuries Pu-238 1 curie Pm-147 i (c) ,G h .

/

4 (1) Type 1 - Moi ices manufactured and d l Use of sources contained in gauging devfic l c

buted in accordance with a speciThese devices are de Each device con-provisions of 10 CFR 32.120. and density of materials. During measurement of both moisture be encapsulated asthe one sour l tains two isotopes which may ain in the device or lbe beingmoved measurements the source (s) may reminto a prepared end of a rod from the device ( ) is retracted inside t Following the measuremant the source s l sampled.

device. Maximum M Isotope 45 millicuries Cs-137 100 millicuries An-241:Be l

(2) h. devices manufactured

Use of sources contained in gaugingfic licen buted in accordance with a speci i

l FRN 10 CFR 30 13

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.._,04/11/84- ~ ~ - - . - '*~"*ww,_., _% ,

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l These devices are portable and are designed to )

provisions of 10 CFR 32.120.

measure the surface moisture of materials.

Maximum Activity Isotope Am-241:Be 100 millicuries (3) Type 3 - Density cauces.

Use of sources contained in gauging devices manufactured and distri-buted in accordance with a specific license issued according to the pro-These devices are portable and are designed to visions of 10 CFR 32.120.

measure density of material under field conditions.

. Maximum Activity Isotope 200 mil 11 curies Cs-137 L

(d) Group IV - Irradiators.

j.

h- (1) Type 1 - Self contained dry storace irradiators.

g

~. Use of sources contained in devices manufactured and F

accordance with a specific license issued according to the provisions g

These devices are designed for irradiation of small P

10 CFR 32.120.

1 The sources are dry L samples for research and commercial purposes.

shielded and stationary.

Maximum Activity t- Isotope h

. 26400 curies Co-60 L 4200 curies I Cs-137 (e) Group V - Calibrators.

(1) Type 1 - Gamma-ray calibration devices.

Use of sources in devices manufactured and distribut with a specific license issued according to the provisions of 10 CFR 14 FRN 10 CFR 30 32 40 7 04/11/84 l

[7590-01]

These devices are designed for use in fixed facilities for 32.120. h calibration of portable gamma-ray survey meters or dosimetry devi as thermoluminescent dosimeters (TLD).

Maximum Activity Isotope 200 mil 11 curies Cs-137 Group VI - Radiography exposure devices.

(f)

(1) Type 1 - Panoramic (crankeutl.

Use of sources contained in devices manufactured i f accordance with a specific license issued according to the provis ons f These devices are designed to perform industrial radiog-10 CFR 32.120.

During use, the source is raphy in both fixed and field locations.

f- i F

^

moved from its shielded storage position to a fully exposed posit on After exposures are outside the exposure device (panoramic exposure).

- complete, the source is restricted to a shielded position.

7 Maximum Activity L Isotope i: Ir-192 (portable) 200 curies P

200 curies L Co-60 (fixed) installation k

Co-60 (portable) 100 curies n

(2) Type 2 - Beam (pipe 11ner).

i

Use of sources contained in devices manufactur f p

accordance with a specific license issued according to the prov h These are portable devices which are., designed for use 10 CFR 32.120.

i field industrial radiography. These devices (often referred to as a ff" pipeliner) are placed in position on a pipe and the source "on 15 FRN 10 CFR 30 32 40 7 04/11/84

[7590-01]

The mechanism operated to allow radiation to be beamed as required.

source remains inside the device during exposure.

Maximum Activity Isotope 200 curies Ir-192 PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

4. The authority citation for Part 32 is revised to read as follows:

AUTHORITY:

Sees. 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 amended (42 U.S.C. 5841).

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

32.19, 32.25(a) and (b),

2273); $$ 32.13, 32.15 (a), (c), and (d),

32.58, 32.59, and 32.62 32.29(a) and (b), 32.54, 32.55(a), (b), and (d),

are issued under sec. 161b,-68 Stat. 948, as amended (42 U.S.C. 2201(b));

and SS 32.12, 32.16, 32.20, 32.25(c), 32.29(c), 32.51a, 32.52 and 32.56 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).

are issued under sec.

5. A new Subpart 0 is added to Part 32 to read as follows:

I f

16 FRN 10 CFR 30 32 40 70 l 04/11/84

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SUBPART D - SPECIFICALLY LICENSED SOURCES AND DEVICES

$ 32.120 Byproduct inaterial contained in sources or ta devices contain ino sources for use under S 30.35: recuirements for Itcense to manu facture or initially transfer.

An application for a specific Itcense to manufacture or initially transfer sources containing byproduct material or devices containing such as those listed in 10 CFR 30.72 of this chapter to persons specifically licensed under S 30.35 of t[is chapter or squivalent regulations of an Agreement State will be approved if --

(1) Theapplicanisatisfiesthegeneralrequirementsof630.33of this chapter; (2) The applicant submits the following information to the NRC (1) Sources (A) Model number and type; (B) Isotope, chemical and physical form and maximum activity; (C) Leak test frequency. The NRC normally requires a six month interval. In the event the source manufacturer desires a longer leak test i

interval, the application shall contain sufficient information to demon-l strate that such longer interval is justified by the performance charac-l teristics of the source, or request that the NRC determine an acceptable l 1eak test interval based on information which includes but is not limited 1

I to:

(1) The ANSI classification of the source; (2) The radiotoxicity of the contained radioisotope (s);

(3) Operating experience with identical or similarly designed and l constructed sources (s);

04/11/84 17 FRN 10 CFR 30 32 40 70 l

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(D) A precise, concise description of the source including construc-tion materials, dimensions, fabrication and sealing methods and chemical and physical form of the radioisotope (s). The description should include

• a package of engineering drawings that identify construction methods, dimensions and procedures for sealing.

(E) A description of the information to be engraved, etched or imprinted on the source and a description of the type and location of warning labels to be used. The label for a source should include the f

u words " CAUTION-RADI0 ACTIVE MATERIAL", e th' manufacturer's name or trade-fc i

mark, the model number or unique serial number, radioisotope (s),

activity, assay date, and the radiation trefoil symbol. Where labelling is impracticable, a tag containing the above information should be F

attached to the source, unless the attachment of such a tag is also r- impracticable. When a source is permanently mounted in a device, source f labelling is not required provided the device is labelled.

i (F) A description of the planned use(s) of the source and the i

e y expected environment and operating conditions during norral use. Describe f type of users, locations of use, circumstances of normal use and possibil-ities of use as a component in other products. Indicate the expected

[

I useful life and describe probable effects of severe conditions, including L

F accidents and fires and possible diversion from intended use, I

i (G) Prototype testing and evaluation information as follows:

L (1) Maximum radiation levels at 5 and 30 centimeters from any external surface of the source averaged over an area not to exceed 100 square centimeters, giving the method of measurement or calculation.

(2) The results of testa performed on prototype sources that establish the integrity of source construction and seal under the most 04/11/84 18 FRN 10 CFR 30 32 40

adverse conditions uf use to which the source is likely to be subjected.

These prototype tests should, insofar as possible, reflect the actual con-ditions of use and, as a minimum, shall meet the designated usage classif; ication of the current ANSI Standard N542 entitled " Sealed Radioactive Sources, Classification" (see accompanying tables), provided the means for assigning such a classification is described.

(H) Describe the quality control program that will be used by the  ;

E source manufacturer to identify any mechanical material discrepancy that f- would be allowed between units and the manufacturing specifications.

i Table 1 Classification of Sealed Source Performance Tests F

i u.

I F

g,,,

I " I a 4 s e at

-4e c se me n -4e cise mi n.

( T.m er.t== - N. Tut - w c(se ms.

+as c 06n +las c phi

-4e c

. geo ye fse ms-4e gig n(gcfsema dd n gig 4ee ci. se c See cie r c ase ci. as c p '

25 kN/an'she. 35 kNIns' aba. SS kN/im abs. 25 kN/mi' aba. :S k N /ms' she.

I Esternet No Tant te 1e MN/mi- to 17e MNism' preaure (3.616.lin') to 2 MNIsn* to 1 M N /en*

te stamesobese ( U ett bl (le 163 Et (21 ti&4 Et f .the6 b/wl wi ei,s. wi .n t

wi .i ~

20s a (T es) S kg (4.4 lbl 5 kg (11 Ib) 2e kg (44 lbn b laneset No Test 50 m H.a est fruen 1 m(8.2e from I as fenssa 1 as , inen 1 an inns I an p

- ft.) and free drop ten names to a a4sel F- , surfaca fauna

• 1.5ess (4.trl ft) .

No Test se anim as ade se ana Net Uend Not Used Vibraties SSlaSee Ha as to se Hs at as te se its at 5 g peak 6 g pesk same, et 1.6 asse aanp.

r sanp. ased Es las et punk to peak Ilsate.436maan andemt Rose l aame. peak Hs at se r

{- t se"us .o. ,

sees (14.4 es) I kg (2J lb) '

Puesture No Test I m (15.4 sen ter H64 sen sear (1.16 as) '

feeus1am(3.2eit) freen I m fruen I se (see i en femen I am ,

I l l

l 19 FRN 10 CFR 30 32 04/11/84

,--+---,-w---y-,,-,.,,-,r.v----,,-- -. - , - . , , -%. _,.-,.--,,,-,..--,_--.-,.m. -

[7590-01]

Table 4 Sealed Source Performance Requirements for Typical Usage Sealed Soum Test and Class Sealed Source Usage Tempers. Pres- Vibra. Par ture sun impact tion tur Unprotseted so'u rce 4 3 5 1 5 Radiography-Industrial

• 4 3 3 1 3 Source in device Radiography 3 2 3 1 2 Medical 5 3 5 2 4

• Ga--- teletheracy Unpretected source 4 3 3 3 2 Gamma gauges (snedium and 3 2 3 2 high energy). Source in device 4 3 3 2 2 2 Beta rauges and sources for low enerry gamma mauses or X-Ray Suorescence analysis (excluding gas $11ed sources) 5 8 5 2 3 Oil Welllogging

[ 4 .3 3 3 3 Portable nmsture and density sauce (includina hand held '

or dolly transported) g 4 3 3 2 3 Ceneral neutron source application (excluding naetor R

start up) 7 2 2 1 1 Calibration sourece-Activity greater thaa 30 sCl ,

1 L

4 3 4 2 4 Camma Irradiators

• Catseeries II. III. IV 2 y Catswory I 4 3 3 2 t Chromatoersohy 3 2 2 1 *

". Ion 2enerators' Static Eliminasses 2 2 2 2 L 3 2 2 2 .

Smoke Detseesta

{

$ DLT M*$"*s.*l"Td " i w w s, t

c:::::: !,-?"'I " " o.,8#

c

te vc.=::.::::-

r i

y C

i

?

r .

V r

(11) Devices L

(A) Model number and type; (B) The source model designation and source manufacturer /distributo L

Unless the' source has been previously evaluated, provide the information required for sources in (i) above. Include the maximum activity and iso-tope to be used in device.

04/11/84 20 FRN 10 CFR 30 32 4

[7590-01]

The NRC normally requires a six month (C) Leak test frequency.

interval. In the event the manufacturer or initial distributor desire longer leak test interval, the application shall contain sufficient inf mation to demonstrate that a longer interval is justified on the basis operating experience with an identical device or one of similar desig (The leak test should and construction used under similar conditions.

consist of swiping of all, if, practical, external surfaces of the device.

Particular attention should be given to areas where the device has been In most cases, the NRC does bolted or welded together to form a seal.

f not require that the device be disassembled and the sources smear t

for removable contamination.)

c (D)

A precise, concise description of the device including construc-tion materials, dimensions, design, shielding, fabrication, "on-off" h

c-mechanisms and indicators and methods of securing the source (s) in kr Provide a brief statement that will provide the reviewer an j device.

The description should understanding of the capabilities of the device.

{i be accompanied by a package of engineering drawings that identify ccn p

tion methods, dimensions, safety components and descriptions of t L A copy of the operation and service manual on the I'$

device installations.

L device should be included.

{ (E)

A description of the label to be affixed to the device and its V-

' location. As a minimum the label should contain the manufacturer or b

~

distributor's name or trademark, model number or unique serial numb radioisotope (s), activity, assay date, the radiation trefoil symbol an the words, " CAUTION RADI0 ACTIVE-MATERIAL."

A range of operating (F) A description of the planned normal use.

conditions for each environmental condition should be specified for 21 FRN 10 CFR 30 32 40 04/11/84

• ', [7590-01]

}

device except in the case of custom devices. The range of operating conditions should include, as a minimum, temperature, vibration, impact, puncture, compression loadings, corrosive nature of the atmosphere, and potential for fire or flooding in the area in which the device is to be I

used. Include descriptions of the types of users, locations of use, I possibilities of use as a component in other products and the circum-stances of normal use. Specifically indicate whether the device will be moved during normal use; for example - whether it will slide on a track, rotate, swing on and off line 'and whether it is portable. Indicate the expected useful life of the device.

(G) Indicate wheiiher or not the device is a custom device. Devices manufactured per the unique specification of and for use by a single appit-cant are considered custom devices. Devices designed and constructed as =

off-the-shelf items or for u*.e by more than a single applicant are not deemed to be custom devices and should'not be so registered. If the e

device is a custom device the name and address of the company planning to use the device must be given as well as the name and telephone number of the cognizant individual who will use the device at the company facility.

(H) Prototype testing and evaluation information as follows:

(1) Radiation dose rates in millirems per-hour at the surface, at 5, 30, and 100 centimeters from the surface for the device with the shutter (s) in closed position and in the open position. As a minimum these readings should be taken at four equally spaced points in both the longigudinal and transverse planes. A descripticn of the method used to make the measurements and a description of the measurement locations shculd be included.

04/11/84 22 FRN 10 CFR 30 32 40 70

~

[7590-01]

(2) The results of tests performed on prototype devices. The tests and/or engineering analysis should, insofar as possible, reflect the actual conditions of use. The tests shall be performed on a device that is of the same design and fabr'cated in a manner that can be duplicated in production units, especially in regard to materials, tolerances and methods of construction. In the event that the device is a custom device, engineering analysis may be used in lieu of test data or as a minimum an operational test of the device should be made and the device swipe tested for removable contamination. Historical data'or engineering analysis data on the units or similar units should also be submitted to reinforce any statements made.

(I) Describe the quality control program that will be used by the device manufacturer to identify any mechanical or material discrepancy that would be allowed between units and the manufacturing specifications.

PART 40 - DOMESTIC LICENSING OF SOURCE MATERIAL

' 6. AUTHORITY: Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68 Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs. 11e(2) 83, 84, Pub. L.95-604, 92 Stat. 3033, as amended, 3039, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2014(e)(2), 2092, 2093, 2094, 2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); secs. 274, Pub. L.86-373, 73 Stat.

688 (42 U.S.C. 2021); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

l Sec. 40.7 also issued under Pub. L.95-601, sec. 10, 92 Stat.

2951 (42 U.S.C. 5851). Sec. 40.31(g) also issued under sec. 122, 68 04/11/84 23 FRN 10 CFR 30 32 40 70

. . [7590-01]

Sec. 40.46 also issued under sec.184, 68 Stat.939(42U.S.C2152). Sec. 40.71 also issued under Stat. 954, as amended (42 U.S.C. 2234).

sec. 187, 68 Stat. 955 (42 U.S.C. 2237). (42U.S.C.

For the purposes of sec. 223, 68 (Stat. 958, as amende

) and (c), 40.46, 2273); 55 40.3, 40.25(d)(1)-(3), 40.35(a)-(d), 61b, 68 Stat.40.41 948, as b 40.51(a) and (c), and 40.63 are issued under sec. 1 d (d)(3) and (4),

amended, (42 U.S.C. 2201(b)); and 55 40.25(c) an d 40.65 are issued 40.26(c)(2), 40.35(e), 40.42, 40.61, 40.62, 40.64 an

' SC 2201(o)).

under sec. 161o, 68 Stat. 950, as amended (42 U. . .

7. Section 40.33 is added to read as follows:

' S 40.33 Sources and devices. tion, an Subject to the provisions of paragraph (b) of this sec (a) containing source

$ application for a specific license to use roved sources for the *uses '

material or devices containing sources will be app n specified in the application if -- 0 32.

The applicant satisfies the general requirements nta-(1)

F. The applicant's radiation detection and measurin (2) d s involved in the uses f.

tion is adequate for conducting the proce ure b

specified in the application; and for The applicant's radiation safety procedures are a E (3)

)

the uses proposed in the application. d 5 40.36 I[ (b)

The sources or devices applied for must be appr before a license application or equivalent regulations of an Agreement State to use them may be approved.

I FRN 10 CFR 30 32 4 24 04/11/84

l

.- .a . , [7590-01]

i

8. Section 40.36 is added to read as follows:

Source material contained in sources or in devices containing

$ 40.36 reouf rements for-license to manufacture _

sources for use under 6 40.33:

or initially transfer.

(a)

An application for a specific license to manufacture or ini h

transfer sources containing source material or devices containing su sources to persons specifically licensed under_5 40.33 of this chap equivalent regulations of an Agreement State will be approved .

.! [ -

The applicant satisfies the general requirements of 5 40.32 (1) 1 this chapter;

' The applicant submits the following information to the NRC (2) r I (i) _Sources F

l- .

(A) Model number and type;-

{ ~

Isotope, chemical and physical form and maximum activity; (B) '

The NRC normally requires a six month

- (C) Leak test frequency.

y In the event the source manufacturer desires a longer leak

' interval.

.} interval, the application shall contain sufficient information tc de p

strate that such longer interval is justified by the performance c i t ble

" teristics of the source, or request that the NRC determine an accep leak test interval based on information which inc F

to:

l E f (1) The ANSI classification of the source;

l. [ The radiotoxicity of the contained radioisotope (s);

f (2)

! (3)

Operating experience with identical or similarly desig constructed sources (s);

(D)

A precise, concise descripton of the source including cons

- d chemical tion materials, dimensions, fabrication and sealing methods an l

l 25 FRN 10 CFR 30 32 40 04/11/84

[7590-01]

and physical form of the radioisotope (s). The description should include a package of engineering drawings that identify construction methods, dimensions and procedures for sealing.

(E) A description of the information to be engraved, etched or imprinted on the source and a description of the type and location of warning labels to be used. The label for a source should include the words " CAUTION-RADIOACTIVE MATERIAL", the manufacturer's name or trade-mark, the model number or unique serial number, radioisotope (s),

I- activity, assay date, and the radiation trefoil symbol. Where labelling 3 is impracticable, a tag containing the above information should be attached to the source, unless the attachment of such a tag is also b impracticable. When a source is permanently mounted in a device, source i labelling is not required provided the device is labelled.

(F) A description of the planned use(s) of the soJrce and the expected environment and operating conditions during normal use,

[

r.

Describe type of users, locations of use, circumstances of normal use and 1

[

possibilities of use as a component in other products. Indicate the

[

expected useful life and describe probable effects of severe conditions,

[ .

L including accidents and fires and possible diversion from intended use.

t l (G) Prototype testing and evaluation information as follows:

l

! c (1) Maximum radiation levels at 5 and 30 centimeters from any g

w E

external surface of the source averaged over an area not to exceed L 100 squarat centimeters, giving the method of measearement or ca.lculation.

(2) The results of tests performed on prototype sources thate establish the integrity of source construction and seal under the most adverse conditions of use to which the source is likely to be subjected.

1 I

l l

26 FRN 10 CFR 30 32 <

04/11/84 l

1

[7590-01]

These prototype tests should, insofar as possible, reflect the actual conditions of use and, as a minimum, shall meet the designated usage classification of the current ANSI Standard N542 entitled " Sealed Radio-active Sources, Classification" (see accompanying tables), provided the means for assigning such a classification is described.

(H) Describe the quality control program that will be used by the source manufacturer to identify any mechanical material discrepancy that I' would be allowed between units and the manufacturing specifications.

~

C

's I

L

?

h F

r w

L r

?

E L

i F

i i

27 FRN 10 CFR 30 32

• 04/11/84

A_A -- _ .a . . .:+_ ,

[7590-01) I e Tests Table 1 Classification of Sealed Source Performa x

s i

J s Speelal ,

4 Test

~

. l

- erC(M asiel e +8AFC(th) 4rCih nie)d thermal abak er Cite miel +MFC(thi an

" I erC(M miel 4ee C(th) and thennel shock tot *C to M*C Speulel

~4r C(se mie) +100*C (th) . +bt rimal ehech Get*C to M*C 26 kNf n.' she. Test No Ted +4e*C (th) 404*C tw M*C 25 kN/m' eLa. te 170 MNiem' retaneo

• 26 kN/m'she. to14 MNien* (24 4666 El _

35 kNise' abe. tel MNIm' Sfeariel W(le 1 ='a. 163 b l

~ ~ ~No Test 28 kHinn'she.

(3.5 lb.fla'l to 2 hNiin' (the b/W) w(1 i e6elb _ El

_ J_W(44b) 24 ha Ted W . 5 kg (Il Ib) frees I m le etenseshere aba- ,

me 3 km (4.4 El frienIen See a (Tes) femen i en ,

' 1.8est from I m

• Me Test 60 g (1 m(3.38 frun est it.) and free .

,

• Special drop tem tunes -

Test Nd Used to e n'oel Het Used esclass inssa __ M min 4.5ee (4.01ft) la t et ils M mis et 1.6 e.as emp.

M min SS no u Ha at

_ He Test 25 to P 4 lis 5 g punk eene, punk to timek

• c.um. et& s Seek and50to M end w 4. Sees

, emp. lls et e 634 men  !!s et M r , Spesist ease seek te I kg (IJ lb) Test punk and et to 18.8 es) fann 1in l 500 als etle a Beer fase (I m j l not (1.76 eel leg (164 arl g f r.ans I a.

I a (IE 4 eri f esse I en No Test fremtI m (3.20ft)  ;

Etzt3 l

l .

i FRH 10 CFR 30 32

. 28 04/11/84

• I o ,-

[7590-01]

Table 4 Sealed Source Performance Requirements for Typical Usage Sealed Source Test and Class ,

5ealed Source Usage Tempera- Pres- Vibra. Pane- I ture sure Impact tion ture

\

Radiography-Industrial ' Unpretected source 4 3 5 1 5 Source la devim 4 3 3 1 3 Medical Radiarraphy 2 2 3 1 3 Gamma telethersey 5 3 5 2 4 Gamma sausse (medium and Unpretected source 4 3 3 3 3 l high energy) Source la device 4 3 2 3 2 Beta asugen and sources for low enerry assuna raures 3 3 2 2 2 or X. Ray fluorescence analysis (ea~luding e gas Alled sourton)

Oil 'Nell, logging 5 4 5 2 3 Portable meisture and density gauge (including hand held 4 .3 3 3 3 1 or dolly transported)

General neutron eseree appliention (escluding reactor 4 3 3 2 3 start up)

Calibration sourtes-Activity greater thaa 30 aCl 2 2 2 1 1 Camma Irradiators

• Catenerise !!. III. IV 4 3 4 1 4 Catenery I 4 3 3 2 3 fon generators' Chromatorraohr 3 2 1 1 1 .

Statie Eliminators 2 3 1 2 3 Smoke Detmeters 3 2 2 3 3

• U"ta". 1"J" *sillllI *I." ** i n m i e , e c"':llIn 3 2" "

• J or,'.'.' si 8.. ;; !L-*,.".1 ss "s .?l-#-

"

• a -

(ii) Devices l

j (A) Model number and type; (B) The source model designation and source manufacturer / distributor.

Unless the source has been previously evaluated, provide the information l

required for sources in (1) above. Include the maximum activity and iso-tope to be used in device.

l 04/11/84 29 FRN 10 CFR 30 32 40 70

. _ - - . . , ,.,_.___.m_ - - _ _ . _

_ ,__.__,-___,._mm _ _ . , , -_ _ _ _ . -

• ~ '

r . ,' [7590-01]

1 (C) Leak test frequency. The NRC normally requires a six month In the event the manufacturer or initial distributor desires a

~

interval.

longer leak test interval, the application shall contain s'ufficient infor-mation to demonstrate that a longer interval is justified on the basis of operating experience with an identical device or one of similar design ,

and construction used under similar conditions. (The leak test should consist of swiping of all, if practical, external surfaces of the device.

Particular attention should be given to areas where the device has been

~

bolted or welded together to form a seal. In most cases, the NRC does not require that the device be disassembled and the sources smear tested for removable contamination.)

(D) A precise, concise description of the device including construc-tion materials, dimensions, design, shielding, fabrication, "on-off" mechanisms and indicators and methods of securing the source (s) in the device. Provide a brief statement that will provide the reviewer an understanding of the capabilities of the device. The description should l

be accompanied by a package of engineering drawings that idencify con-i struction methods, dimensions, safety components and descriptions of typical device installations. A copy of the operation and service manual on the device should be included.

(E) A description of the lat:e1 to be affixed to the device and its

! location. As a minimum the label should contain the manufacturer or 1 - distributor's name or trademark, model number or unique serial number, radioisotope (s), activity, assay date, the radiation trefoil symbol and the words, " CAUTION-RADI0 ACTIVE MATERIAL."

l (F) A description of the planned use of the device and the expected h

environment and operating conditions during normal use. A range of 30 FRN 10 CFR 30 32 40 70 04/11/84 l

...__m _ ____________u_____ _

[7590-01]

d ental condition should be specifie The range of operat-operating conditions for each environm devices.

t for the device except in the case of customminimum, tempe

+

'ing conditions should include, sive as a nature of the atmosphere and puncture, compression loadings, h corro area in which the device is to potential for fire or flooding in t e locations of use,

" 1 used. Include descriptions of the types of users,in othe ill be moved possibilities of use as itawillcomponentSpecificall slide on a track, of normal use.

Indicate the during normal use; for example - whetherd whether it i rotate,' swing on and off-line an Devices expectedusefullifeifthedevice. t m device.

li-(G) Indicate whether or not the device is a cu manufactured per the unique speci Devices designed and constructed as 1 cant are considered custom devices. re than a single applicant are l

, off-the-shelf items or for use by mo be so registered. If the device deemed to be custom devices and should fnotddress the ,

is a custos device the name and all as the name and teleph the device m.ust be given as we device at the company facility.

h cognizant individual who will use t e i n as follows:

Prototype testing and evaluation h informat o at the s (lf)

(I) Radiation dose rates is utilfrems-per- ourfac .

5, 30, and 100 centimeters from the surtheAsopen a minimumposition.

shutter (s) in closed position end infour equally spaced p these readings should be takenAatdescription of the method used to longitutinal and transverse planes.f the measurement locations measurements and a description o make the

, should be included.

j FRN 10 CFR 30 32

. 31 04/11/84

[7590-01] j i

~

l (2) The results of tests performed on prototype devices. The tests and/or engineering analysis should, insofar as possible, reflect the actual conditions of use. The tests shall be performed on a device that is of the same design and fabricated in a manner that can be duplicated in production units, especially in regard to materials, tolerances and methods of construction. In the event that the device is a custos device, engineering analysis may be used in lieu of test data or as a minimum an operational test of the device should be made and the device swipe tested for removable contamination. Historical data or engineering analysis data on the units or similar units should also be submitted to reinforce any statements made.

(I) Describe the quality control program that will be used by the device manufteturer to identify any mechanical or material discrepancy that would be a.llowed between units and the manufacturing specifications.

PART 70 - DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL

9. The authority citation for Part 70 is revised to read as follows:

AUTHORITY: Secs. 51, 53, 161, 182, 183, 68 Stat. 929, 930, 948, 953, 954, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2071, 1073, 2201, 2232, 2233, 2282); secs. 201, as amended. 202, 204, 206, 88 Stat. 1242, as amended, 1244, 1245, 1246 (42 U.S.C. 5841, 5842, 5845,

5846). .

i Sec. 70.7 also issued under Pub. L.95-601, sec. 10, 92 Stat.

2951 (42 U.S.C. 5851). Sec. 70.21(g) also issued under sec. 122, 68 tat. 939 (42 U.S.C. 2152). Sec. 70.31 also issued under sec. 57d, Pub. L.93-377, 88 Stat. 475 (42 U.S.C. 2077). Secs. 70.36 and 70.44

! 04/11/84 32 FRN 10 CFR 30 32 40 70

, , , [7590-01]

also issued under sec. 184, 68. Stat. 954, as amended (42 U.S.C. 2234).

Sec. 70.61 also issued under secs. 186, 187, 68 Stat. 955 (42 U.S.C.

2236,2237). Sec. 70.62 also issued under sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138).

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

2273);5570.3,70.19(c),70.21(c),70.22(a),(b),(d)-(L),70.24(a)(b) 70.32(a)(3), (5), (6), (d), and (1) 70.36, 70.39(b) and (c), 70.41(a),

70.42(a),and(c),70.56,70.57(b),(c),and(d),70.58(a)-(g)(3),and 1

(h)-(j) are issued under sec. 161b, 68 Stat.'948, as amended (42 U.S.C.

' ,/

2201(b)); 55 70.7, 70.20a(a), and (d) 70.20b (c), and (e) 70.21(c),

70.24(b), 70.32(a)(6),'(c), (d),(e), and (g), 70.36,70.51(c)-(g),70.56, 70.57(b) and (d), 70.58(a)-(g)(3) and (h-j) are issued under sec. 1611, 68 Stat. 949, as amended (42 U.S.C. 2201(1)); and 55 70.20b(d) and (e),

1 70.51(b) and (1), 70.52, 70.53, 70.54, 70.55, 70.58(g)(4), (k), and (1),

70.59, and 70.60(b) and (c) are issued under sec. 1610, 68 Stat. 950, as l: amended (42 U.S.C. 2201(o)).

10. Section 70.43 is added to read as follows:

5 70.43 Sources and devices.

(a) Sebject to the provisions of paragraph (b) of this section, an application for a specific license to use sources containing special

+ nuclear material or devices containing sources will be approved for the use(s) specified in the application if --

(1) The applicant satisfies the general requirements of 5 70.23; I (2) The applicant's radiation detection and measuring instrumenta-J tion is adequate for conducting the procedures involved in the uses specified in the application; and 04/11/84 33 FRN 10 CFR 30 32 40 70

' " . [7590-01]

(3) The applicant's radiation safety procedures are adequate for the uses proposed in the application.

(b) The sources or devices applied for must be approved under 5 70.45 or the equivalent regulations of an Agreement State before a Itcense appli-cation to use them may be approved.

11. Section 70.45 is added to read as follows:

5 70.45 Special nuclear material contained in sources or in devices containing sources for use unde. 5 70.43: requirements for license to manufacture or initially transfer.

(a) An applicati$n for a specific license to manufacture or initially transfer sources containing special nuclear material or devices 1 containing such sources to persons specifically licensed under 5 70.43 of this chapter or equivalent regulations of an Agreement State will be approved if -

(1) The applicant satisfies the general requirements of 5 70.23 of this chapter; (2) The applicant submits the following infomation to the NRC (1) Sources (A) Model number and type; (B) Isotope, chemical and physical fom, and maximum activity; ,

(C) Leak test frequency. The NRC nomally requires a six month interval. In the event the source m'anufacturer desires a longer leak test interval, the application shall contain sufficient infomation to demonstrate that such longer interval is justified by the perfomance 04/11/84 34 FRN 10 CFR 30 32 40 70

.. ~..

[7590-01]

characteristics of the source, or request that the NRC determine an acceptable leak test interval based on information which includes but is not limited to:

(1) The ANSI classification of the source; (2) The radiotoxicity of the contained radioisotope (s);

(3) Operating experience with identical or similarly designed and constructed sources (s);

(D) A precise, concise description of the source including construc-

~

- tion materials, dimensions, fabrication and sealing methods, and chemical and physical form of the radioisotope (s). The description should include apackageofengineeriigdrawingsthatidentifyconstructionmethods, dimensions and procedures for sealing.

(E) A description of the information to be engraved, etched or imprinted on the source and a description of the type and location of warning labels to be used. The label for a source should include the words " CAUTION-RADI0 ACTIVE MATERIAL", the manufacturer's name or trade-mark, the model number or unique serial number, radioisotope (s),

activity, assay date, and the radiation trefoil symbol. Where labelling is impracticable, a tag containing the above information should be attached to the source, unless the attachment of such a tag is also impracticable. When a source is permanently mounted in a device, source labelling is not required provided the device is labelled.

(F) A description of the planned use(s) of the source and the expected environment and operating conditions during normal use. Describe type of users, locations of use, circumstances of normal use and possibil-ities of use as a component in other products. Indicate the expected 04/11/84 35 FRN 10 CFR 30 32 40 70

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

. '.' [7590-01]

useful life and describe probable effects of severe conditions, including accidents and fires and possible diversion from intended use.

(G) Prototype testing' and evaluation information as follows:

(1) Maximum radiation levels at 5 and 30 centimeters from any external surface of the source averaged over an area not to exceed 100 square centime *. ors, giving the method of measurement or calculation.

(2) The results of tests performed on prototype sources that i

establish the integrity of source construction and seal under the most adverse conditions of use to which the source is likely to be subjected. ,

, ,/

These prototype tests should, insofar as possible, reflect the actual conditions of use and, as a minimum, shall meet the designated usage classification of the current ANSI Standard N542 entitled " Sealed Radio-4 active Sources, Classification" (see accompanying tables), provided the 4

means for assigning such a classification is described.

(H) Describe the quality control program that will be used by the source manufacturer to identify any mechanical material discrepancy that I would be allowed between units and the manufacturing specifications.

8 1

J

]

j 4 04/11/84 36 FRN 10 CFR 30 32 40 70 l

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l i i I

[7590-01] l l

Table 1 Classification of Sealed Source Performance Tests .

l 1

aan T a e a e x i s

s,= lei m.,e,de,e N. T -wc(se miei - w c(se mani

-ec$semie)d we$asuden see nhn esa -wcdas eer o6mien Test

+ w c phi +iwc phi ene nhi ee obisk reisel sheek abeek 400*c le wc eas*cto w C Ase*cto w c 26 kN/ses' abe. S8 kW/se' abe. M kN/se* eks. Spectet K;ter::al No Test 36 kN/se* ehe. SS kWise' abe.

to I M N/se' to to MN/ei' te lie M N/en' Ted pee,e ,3 (3.8 h/le ) to 1 M N/ ass' G IenW b t te atenesen.'ees (too blie') O ett bt He163lb./

ebe. taal abe. w)ek ---

in') eks. <

1 t kg (4.4 lbl 6 kg (Il li.) se km (44 lb) Speeiel Imoert He Teet M e (l.a een seea (7 een Ted frase I m(3.34 freen I en fease i en frase 1 en froom I se it.) and free deep tea taasee ,

to e steet eenrface fouse '

1 Jam (4.e8 ft) .

38 inia 30 mis se men Het Use.1 Net Used Special Vibeetlesi No Test Tese 36 te See lis 25 to M Ne et ts to se its et & a peak & w sansk ease, et I.h enen eenp.

en p. esed W to se peaktoeseek 14: et e.sas seen messi se to tiente eene. ensk to lis et 3D r and to to lls et le a seeg (14.5 een I kg (22 lb) Spartel ,

Peasters No Test I a (16.4 sen lee (164 erl set (1.14een .

Test freen I se(3.28ft) fesse I en fseem I ese fases I en fewen I se i

2 j

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i 04/11/84 37 FRN 10 CFR 30 32 40 70

-,-------,-~_yp__ c.,_ , , _ , - - - , , _w -

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[7590-01]

Table 4 Sealed Source Performance Requirements for Typical Usage 5eated Source Test and Class Sealed Scurce Usage Tem pera. Free. Vibra- Pane.

ture sure Impact tion ture Radiography-Industrial ' Unprotseted source 4 3 5 1 5 Source in device 4 3 3 1 3 Medical Radiarraohr 3 2 3 1 2 Camma teletherapy 5 3 5 2 4 Gamma gauges (seedium and Unprotected soerce 4 3 3 3 3 bigh energy) Source la device 4 3 2 3 2 Beta rauses and sources for low energy ramma raunes 3 3 2 2 2 or X. Ray Ruorescence analysis (escluding gas Alled neureus)

Oil Well,logsms 5 .4 5 2 3 Portable mouture and density gauge (includir.g hand held 4 .3 3 3 ,

3 er dolly tesnaported)

General neutron seuree app!! cation (escludina reactor 4 3 3 2 3 start up)

Calibration seurece-Activity greater thes 30 pCi 2 2 1 1 S Camma Irradiators' Categor!ee II. III. IV 4 3 4 1 4 Category I 4 3 3 2 3 fon generators' Chromatorraphy 3 2 2 1 1 Statie Eliminators 2 2 2 2 2 Saske Detectors 3 2 3 2 3

g g g y,.-.._, _ .

s=; wy = = -

(ii) Devices (A) Model number and type; (B) The source model designation and source manufacturer / distributor.

Unless the source has been previously evaluated. provide the information required for sources in (1) above. Include the maximum activity and isc-tope to be used in device.

04/11/84 33 FRN 10 CFR 30 32 40 70

. . [7590-01]

(C) Leak test frequency. The NRC normally requires a six month interval. In the event the manufacturer or initial distributor desires a longer leak test interval, the application shall contain sufficient infor-mation to demonstrate that a longer interval is justified on the basis of operating experience with an identical device or one of similar design and construction used under similar conditions. (The leak test should consist of swiping of all, if practical, external surfaces of the device.

Particular attention should be given to areas where the device has been bolted or, welded together to form a seal. In most cases, the NRC does notreqbirethatthedevicebedisassembledandthesourcessmeartested for removable contamination.)

(D) A precise, concise description of the device including construc-tion materials, dimensions, design, shielding, fabrication, "on-off" mechanisms and indicators and methods of securing the source (s) in the I device. Provide a brief statement that will provide the reviewer an

.o understanding of the capabilities of the device. The description should be accompanied by a package of engineering drawings that identify con-

! struction methods, dimensions, safety components and descriptions of

! typical device installations. A copy of the operation and service manual on the device should be included.

(E) A description of the label to be affixed to the device and its i location. As a minimum the label should contain the manufacturer or distributor's name or trademark, model number or unique serial number, 1

j radioisotope (s), activity, assay date, the radiation trefoil symbol and I the words, " CAUTION-RADIOACTIVE MATERIAL."

(F) A description of the planned normal use. A range of operating j conditions for each environmental condition should be specified for the l l

! 04/11/84 39 FRN 10 CFR 30 32 40 70

v~ ,-

[7590-01]

device except in the case of custom devices. The range of operating .

conditions should include as a minimum, temperature, vibration, impact, puncture, compression loadings, corrosive nature of the atmosphere and potential for fire or flooding in the area in which the device is to be used. Include descriptions of the types of users, locations.of use, possibilities of use as a component in other products and the circum-stances of normal use. Specifically indicate whether the device will be moved during normal use; for example -- whether it will slide on a track, rotate, swing on and off line and whether it is portable. Indicate the expected useful life of the device.

(G) Indicate whether or not the device is a custom device. Devices manufactured per the unique specification of and for use by a single applicant are considered custom devices. Devices designed and con-structed as off-the-shelf items or for use by more than a single appli-cant are not deemed to be custom devices and should not be so registered.

If the device is a custom device the name and address of the company planning to use the device must be given as well as the name and tele-phone number of the cognizant individual who will use the device at the company facility.

(H) Prototype testing and evaluation information as follows: ,

(I) Radiation dose rates in millirems per-hour at the surface, at 5, 30, and 100 centimeters from the surface for the device with the shutter (s) in closed position and in the open position. As a minimum these readings should be taken at four equally spaced points in both the longitudinal and transverse planes. A description of the method used to make the measurements and a description of the measurement locations should be included.

04/11/84 40 FRN 10 CFR 30 32 40 70 3

[7590-01]

(2) The results of tests performed on prototype devices. The tests

. and/or engineering analysis should, insofar as possible, reflect the actual conditions of use. The tests shall be performed on a device that is of the same design and fabricated in a manner that can be duplicated in production units, especially in regard to materials, tolerances and methods of construction. In the event that the device is a custom device, engineering analysis may be used in lieu of test data or as a minimum an

)

operational test of the device should be made and the device swipe tested for removable contamination. Historical data or, eng'aeering analysis data on the units or similar units should also be submitted to reinforce any statements made.

(I) Describe the quality control program that will be used by the device manufacturer to identify any mechanical or material discrepancy

- that would be allowed between units and the manufacturing specifications.

@ f

lf *

- Dated at Bethesda, Maryland this day of 1984.

For the Nuclear Regulatory Commission.

I f J

,/

William J. Dircks, Executive Director for Operations.

F F

I ,

04/11/h4 41 FRN 10 CFR 30 32 40 70 tve-- ,9y--.w .,-ry,.,,,..,-----p, ..,_.,--y . _ , , , _ __ _

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( /

yi, DRAFT REGULATORY ANALYSIS AMENDMENTS TO 10 CFR PARTS 30, 32, 40, AND 70 -

LICENSING OF SOURCES AND DEVICES 4

1. STATEMENT OF THE PROBLEM The material license application review process for applications submitted under 10 CFR Parts 30, 40, and 70 includes evaluation of the radiation safety adequacy of sources and devic.es containing sources which incorporate radioactive material. The responsibility for the safety evaluation review of these sources and devices is shared by the NRC and the Agreement States.

In order to expedite the application review process, the NRC licensing staff has encouraged manufacturers, distributors and importers of such sources and devices containing radioactive material to submit information to the NRC or Agreement States licensing staffs concerning these products prior to the need for a license to use the products by their customers (license applicants). For the past 35 years this process has been carried out as a voluntary program without specific and well defined regulatory authority applicable to both the supplier and the licensee.

The primary incentive or driving force for the supplier to furnish information is the desire to accommodate its customer, the license applicant.

I One result of this is that the evaluation of sources and devices is frequently

accomplished under considerable pressure on the NRC or Agreement State staffs since the supplier often waits until a sale of the source or device has been made before applying for a safety review. Another result is that the supplier often fails to supply all the needed information so that the ultimate user, the licensee, suffers delays in obtaining license approval and is often forced to 1 Enclosure B

act as a conduit, funneling the required information from the supplier to the i NRC or the Agreement States. f i

An additional problem associated with the present system is the practice

)

of suppliers of requesting a " custom" review of a sealed source or device for a 1 specific customer, with the result that subsequent users of the same item i

(which should be an off-the-shelf item if a complete generic review had been

, performed) often suffer licensing delays and additional costs for subsequent i

. safety reviews required to assess the item safety for their particular operation.

One result of the current practices is the need for some 800 amendments to NRC licenses anhually by users wishing to change from one model of a device containing a source to another to accommodate changes in their operations.

These licensing actions constitute a considerable burden to the materials licensing staff and to the licensees themselves.

Clearly, a generic safety review process is needed for all specifically licensed sources and devices. A classification system which groups devices according to their intended uses could lead to a licensing system which provides for flexibility and would enable licensees to possess and use approved devices I containing sources without the need for license amendments.

2. OBJECTIVES l

I A. Establish a regulatory requirement for suppliers (manufacturers, distributors or importers) of sources or devices which contain radioactive material which will be possessed and used by specific licensees to submit suffi-cient information concerning the devices and sources to the NRC or Agreement States to permit a generic safety review of the sources and devices prior to l

! their distribution to specific licensees. This a requirement would provide a consistent regulatory base for the sources and devices.

i B. Reduce the number of amendments required annually to authorize the use of devices containing sources by specific licensees.

l 2 Enclosure B l

C. Minimize the overall regulatory burden on specific licensees using devices containing sources.

D. Provide a classification system which groups source-device combinations into various use categories to provide flexibility for their possession and use by specific licensees.

3. ALTERNATIVES The regulatory alternatives which could be considered include:

A. Maintain the status quo which relies on the voluntary submission of information on sources and devices by the supplier.

i B. End the current voluntary program and require each applicant to submit design and construction data on sources and devices containing sources it wishes 4

to possess and use.

C. Amend the regulations to require suppliers of sources or devices which incorporate sources, to submit design, construction, quality control and other

information required to conduct a generic safety review on the sources and devices.

! 4. CONSEQUENCES A. Maintain the status quo: The present program of voluntary submission of information lacks regulatory consistency. Regulations are in place which require suppliers of sources or devices which will be distributed to general licensees or persons exempt from licensing to provide adequate information on the sources and devices as needed to perform generic safety evaluations. For consistency similar regulations are needed to require suppliers'to provide adequate information on sources and devices containing sources which will be 3

1 distributed to specific licensees.

Continuation of the voluntary program would have little effect on the suppliers of sources and devices. The approximately 290 suppliers are 3 Enclosure B

l assessed fees of $350 for a generic source safety review and $175 for a custom source safety review, $1600 for a generic device safety review and 5800 for a custom device safety review as provided in 10 CFR 170.31. In addition, up to 5 drawings and 10 pages of text are required, adding an additional $240 for supplier staff time in assembling the material for each of the reviews. The resulting costs are then $590 and $415 for source reviews and $1840 and $1040 for device reviews. The 10 or so suppliers who fail to participate in the voluntary program are unaffected but the licensees who choose to use their products are required to pay the fees assessed under 10 CFR 170.31 and their additional costs will be greater in that they will be acting as a conduit to funnel the required information between the suppliei and the licensing staffs.

Additional costs are also incurred under the current system in that some 800 licensing amendments are required annually because of the lack of a system which would provide flexibility for the devices containing sources which specific licensees may possess and use. At an estimated $60/hr and 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> per amendment, this adds some $48,000 annually to the costs incurred by licensees.

B. End current voluntary registry: The abolishment of the present voluntary system of registry would change little except to transfer the responsibility for transmitting design and other safety information to the j NRC or Agreement States from the manufacturer or supplier to the licensee-user. Although.the suppliers would be relieved the burden of data submittal

! and licensing, identical information would be required from each licensee-user. The overall costs may be expected to increase some since the licensee-user would incur the same fees as those of the supplier (estimated in A above), plus the additional staff costs incurred in relaying the needed information to the licensing staffs.

C. Amend the regulations to require submission of information concerning sources and devices by suppliers: Replacing the current voluntary registration program with a well defined regulatory requirement for licensing information submission maintains the advantages of the current voluntary program and eliminates the disadvantages. The requirement would apply to all suppliers, would eliminate custom reviews, and would reduce the costs to both the licensee 4 Enclosure B I . - - - __. .

users and the NRC and Agreement State 11 censing staffs by requiring generic safety reviews and eliminating the 800 amendments now required annually.

The additional burden to suppliers required by this alternative needs to l

be considered. Although the approximately 290 suppliers have been assessed fees under the existing voluntary program, this is the first time the program would be imposed by regulation or made mandatory. A list of fees assessed is described in A above and an analysis of the costs for safety reviews during 1982 is found in the Regulatory Flexibility Certification of the proposed rule. This analysis shows that costs to suppliers during 1982 were $148,000 and costs to licensee users for license amendments were $48,000'. Under the I proposed rule total costs to suppliers would be increased to $153,000 (based j on 1982 safety reviews) and costs to licensee users would be essentially zero due to elimination of the need for license amendments. Costs to individual suppliers would be determined by the number of items submitted for safety review and can be calculated from the fee schedule given in the above analysis.

The establishment of a generic safety review requirement coupled with a

1 j

generic classification of devices, which includes the maximum quantity of each j specific isotope to be used in the sources contained in the devices, will serve l

to provide increased flexibility for the devices which specific licensees may i possess and use. The licensee-users would be the beneficiaries of the generic 4 review by eliminating the need for the 800 license amendments now required I annually and the costs of some $48,000 described in A above.

5. DECISION RATIONALE Based on the discussion in (4), the staff recommends that alternative C be adopted. Alternative A lacks regulatory consistency and imposes unnecessary burdens in terms of license amendments on both licensee user and on the NRC and

! Agreement State licensing staffs. Alternative B would impose all of the burden on the licensee user with the supplier being relieved of all needs for voluntary i submittal and would probably increase costs since the licensee user would be 1

l acting as an intermediary in the data submittal process. Alternative C would 5 Enclosure B i

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

considerably reduce costs and delays to licensee users, reduce much of the >

burden on Itcensing staffs and at the same time impose minimal burdens on the suppliers.

6. IMPLEMENTATION Rulemaking of air.cr or non policy nature may be' approved by the Executive Director for Operations under authority delegated in 10 CFR 1.40(d). The proposed rulemaking is of a non policy nature in that it merely formalizes the existing voluntary policy of having suppliers of sealed sources and devices submit design and safety information concerning such sources and devices to the NRC and Agreement State licensing staffs.

The rulemaking would be undertaken in two stages: publication of a proposed rule in the Federal Register; and, following consideration of public comments on the proposed rule, a final rule would be published in the Federal Register.

7. NATIONAL ENVIRONMENTAL POLICY ACT (NEPA)

Since the proposed rulemaking would have no effect on currently used procedures, no change in environmental impact will result. As a result, under  ;

the criteria of 10 CFR Part 51 no Environmental Impact Statement is required.

1 8.

PAPERWORK REDUCTION ACT i

! The Paperwork Reduction Act of 1980 (Pub. L.69-511) requires that approval of the information gathering requirements of the proposed rulemaking be sought from the Office of Management and Budget. It should be noted that the informa-tion gathering requirements are, in effect, now required under the voluntary

registration system so that if the supplier fails to provide the required [

information, the licensee user must provide it in order to obtain license approval to use the sealed source or device. Since more than 10 persons are affected by this rulemaking, approval will be sought from OMB.

6 Enclosure B

- .. = - - . .

l.

9. REGULATORY FLEXIBILITY ACT As indicated previously, the proposed rule would have an economic impact on suppliers of sources and devices amounting to approximately $153,000 annually. Costs to individual suppliers would be determined by the number of items submitted. Of the approximately 290 suppliers, approximately 70% are estimated to be small entities as defined by the Small Business Administration in 13 CFR Part 121. On the other hand the proposed rule would benefit some

! 8,000 NRC licensee users, 90% of whom are considered to be small entities. On balance of tradeoff it is considered that the net effect of the proposed rule-making will not have a significant effect on a significant number of small entities. ,

10. RELATIONSHIP TO EXISTING 'OR PROPOSED REGULATIONS OR POLICIES The proposed rulemaking is generically related to the existing regulations in 10 CFR 32.22, 10 CFR 32.26, and 10 CFR 32.51 which apply to distribution to general licensees and persons exempt from licensing of radioactive material introduced into sources and devices. There are no known proposed regulations i or policies that could have an adverse impact on this action. The present voluntary program supports the concept of the proposed change since its exist-ence has helped to minimize the potential impact on suppliers.

l i

l l

l 7 Enclosure B

9 8

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SUPPORTING DOCUMENTS