ML20149L015

Responds to 951108 Fax,Which Contains Copy of Ltr from K Carrington & 951024 Memo from R Penrod

ML20149L015
Person / Time
Issue date:	02/12/1996
From:	Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP)
To:	Spell W LOUISIANA, STATE OF
Shared Package
ML20149L020	List: ML20149L015 ML20149L035
References
NUDOCS 9602230174
Download: ML20149L015 (4)

Text

.

1 L

IfB 121996J Mr. William H. Spell, Administrator Radiation Protection Division Office 'of Air Quality and Radiation Protection 7290 Bluebonnet Road Post Office Box 82135 Baton Rouge, LA 70884-2135 i

Dear Mr. Spell:

This is in response to your November 8, 1995 fax, which contained a copy of a letter you received from Mr. Kenneth Carrington, NDT Repair Service, Inc., and a memorandum from Mr. Richard Penrod, of your office, dated October 24, 1995.

As we have discussed, we have tried to address the concerns raised by Mr. Carrington, and others, in the Information Notice recently issued on i

Section 34.20, and in information provided in NRC's November 20, 1995, letter to Mr. Richard Dicharry, SPEC, Inc., a copy of which was provided to you. We hope the November 20, 1995, letter and Information Notice have been responsive to Mr. Carrington's concerns.

,3 -

The issue of U.S. Customs agents opening' RAM packages, as mentioned in Mr. Penrod's memorandum, is under review and we will correspond separately with you on that issue.

PleasecontactmeorJimhyers(30k-415-2328) if you have questions' on the above matters.

I Sincerely, j

OdginalSignedBW '

PAUL H. LOHAUS Paul Lohaus, Deputy Director Office of State Programs

Enclosures:

1.

Information Notice 2.

Letter dated 11/20/95 to Mr. Dicharry Distribution:

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Mr. William H. Spell, Administrator' "w~

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Post Office Box 82135 Batun Ro LA 70884-2135 Dear Mr. Spel This is in respon to your November 8, 1995 fax, which contained a copy of a letter you received om Mr. Kenneth Carrington, NDT Repair Service, Inc., and a memorandum from Mr.

ichard Penrod, of your office, dated October 24, 1995.

As we have discussed, we ve tried to address the concerns raised by Mr. Carrington, and others, n the Information Notice recently issued on Section 34.20, and in info on provided in NRC's November 20, 1995, letter to Mr. Richard Dicharry, SPEC, c., a copy of which was provided to you. We hope the November 20, 1995, lett and Information Notice have been responsive to Mr. Carrington's concerns.

The issue of U. S. Customs agents ope g RAM packages, as mentioned in Mr. Penrod's memorandum, is under revie nd we will correspond separately with you on that issue.

Please contact me or Jim Myers (301-415-2328 if you have questions on the above matters.

Sincerely, OdginalSigned PAUL H. LOHAUS Paul Lohaus, Deputy D ctor l

Office of State Program

Enclosures:

1.

Information Notice 2.

Letter dated 11/20/95 to Mr. Dicharry cc: DCool/NMSS FCombs/NMSS Distribution:

DIR RF (5S320)

DCD (SP 02)

HLBangart PDR (YES X NO PLohaus SDroggitis JMyers.

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OFFICE OSRy Asl OSP:DD - l OSP:4 ((j l l

l l NAME JMyers WJ PLohausr/ % iht RBangart"W' An o DATE 02/4/96 02/1y with 10 CFR 34.20 is intended, then an exemption request should be su mitted prior to January 1, 1996, to allow the staff adequate time j

to process the request.

Exemptions to 10 CFR 34.20 may be considered only for limited special or unique cases, where the licensee can demonstrate that the engineered safety features, use limitations, and procedures would compensate i

for not meeting the requirements and afford similar or increased radiation j

safety protection. An example of a limited special or unique case would include a nonportable device used in a fixed radiographic facility.

i Performance of radiography after January 10, 1996, with equipment which does not comply with the requirements of 10 CFR 34.20 is a violation of Commission l

l requirements.

In accordance with example C.8 of Supplement VI of the Commission's Enforcement Policy, such violations are considered violations of

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significant regulatory concern and may be categorized at Severity Level III

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and subject to civil penalties.

In light of the notice that has been given licensees to meet this regulation, the time that has been provided licensees j

to achieve compliance, and the importance of meeting the requirements of l

10 CFR 34.20, the NRC intends to levy a civil penalty without considering the normal civil penalty assessment process pursuant to Section VII.A.1 of the Enforcement Policy. Accordingly, a civil penalty of $5,000, the base Severity Level III civil penalty, may be assessed for each camera a licensee uses after A nuary 10, 1996, that does not meet the requirements of 10 CFR 34.20.

If during an ins >ection, the NRC identifies that a licensee is not meeting the regulation, tte licensee will need to suspend any operation with nonconforming cameras.

Failure to do so may be considered deliberate violations and may i

subject the licensee to significant civil action, including license revocation, and to. criminal sanctions.

Individuals responsible for such t

violations may be subject to sanctions for violating 10 CFR 30.10, rule on i

" Deliberate Misconduct."

l i

However, the Commission intends to exercise its enforcement discretion for i

j licensees who make a good faith effort to comply with 10 CFR 34.20 before the offective date of the rule. Therefore, a licensee who performs radiography l

l after January 10, 1996, with equipment that does not meet 10 CFR 34.20 will not be subject to civil peoalties or suspension of operations for such i

violations if the licensee has evidence that on or before January 10, 1996, it i

in good faith ordered equipment for prompt replacement that meets the requirements of 10 CFR 34.20.

It should be noted that Agreement State licensees conducting radiography under reciprocity will be subject to these A

regulatory requirements and enforcement policy.

i L

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IN 95-58 December 18, 1995 Page 4 of 4

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This information notice requires no specific action or written response.

If you have any questions about the information in this notice, please contact one of the technical contacts listed below or the appropriate regional office.

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Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material

~

Safety and Safeguards Contacts:

J. Bruce Carrico, NMSS (For general information)

(301) 415-7826 Thomas W. Rich, NHSS (For device information)

(301) 415-7893 Attachments:

1.

List of Approved Equipment 2.

List of Recently Issued NMSS'Information Notices 3.

List of Recently Issued NRC Information Notices

(

?

4 4

IN 95-58 December 18, 1995 Page 1 of 8 i

(,.

11/21/95 List of Models That Meet 10 CFR Part 34 Requirements CAMERA (S)

Modql Manufacturer Status Description 060 A AMEP. SHAM ACTIVE Co-60 110 mci, Cs-137 10.8Ci, Yb-169 20C1, Tm-170 200Ci, Ir-192 120Ci 660 AE AMERSHAM ACTIVE Co-60 110 mci, Cs-137 10.8Ci, Yb-169 20Ci, Tm-170 200C1, Ir-169 120Ci 660 B AMERSHAM ACTIVE Co-60 110mC1, Cs-137 10.8Ci, Yb-169 20Ci, Tm-170 g

200Ci, Ir-192 140C1 q

660 BE AMERSHAM ACTIVE Co-60 110 mci, Cs-137 10.8Ci, Yb-169 20Ci, Tm-170 200CI, Ir-192 140Ci GGO SYSTEM AMERSHAM ACTIVE Co-60 110 mci, Cs-137 10.8Ci, Yb-169 20Ci, Tm-170 200C1, Ir-192 140Ci 4

G76 A AMERSHAM ACTIVE Co-60 330Ci, DU 168 kg G76 AE AMERSHAM ACTIVE Co-60 330Ci, DU 168 kg G76 B AMERSHAM ACTIVE Co-60 330Ci, DU 168 kg G76 BE AMERSHAM ACTIVE Co-60 330Ci, DU 168 kg

/

'80 A AMERSHAM ACTIVE Co-60 110Ci, DU 129

(

kg 000 AE AMERSHAM ACTIVE Co-60 110C1, DU 129 kg

IN 95-58 December 18, 1995 Page 2 of 8 11/21/95

(.

List of Models That Meet 10 CFR Part 34 Requirements CAMERA (S) (continued)

Mod 71 Manufacturer Status Description 680 B AMERSHAM ACTIVE Co-60 110Ci, DU 129 kg 680 BE AMERSHAM ACTIVE Co-60 110C1, DU 129 kg 684 A AMERSHAM ACTIVE Co-60 11Ci, Ir-192 240C1, DU 68 kg 684 AE AMERSHAM ACTIVE

.Co-60 11Ci, Ir-192 240Ci, DU 68 kg 684 B AMERSHAM ACTIVE Co-60 11Ci, Ir-192 240C1, DU 68 kg

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14 BE AMERSHAM ACTIVE Co-60 11Ci, Ir-192 240CI, DU 68 kg 741 A AMERSHAM ACTIVE Co-60 33Ci, Ir-192 240Ci, DU 90 kg 741 AE AMERSHAM ACTIVE Co-60 33Ci, Ir-192 240C1, DU 90 kg

'44 B AMERSHAM ACTIVE Co-60 33Ci, Ir-192

/

240C1, DU 90 kg i

741 BE AMERSHAM ACTIVE Co-60 33Ci, Ir-192 240Ci, DU 90 kg 865 AMERSHAM ACTIVE Ir-192 240Ci, DU 18 kg IR-100 INDUSTRIAL NUCLEAR ACTIVE Ir-192 120Ci, DU 14.5 kg SPEC 150 SPEC ACTIVE Ir-192 150Ci, DU 17 kg TITAN NORDION ACTIVE Ir-192 140Ci

,I l

m._

IN 95-58 December 18,1995 Page 3 of 8 11/21/9!

List of Models That Meet 10 CFR Part 34 Requirements SOURCE (S) (continued) s Mod 71 Manufacturer Status Description 1

32 INDUSTRIAL NUCLEAR ACTIVE Ir-192 120Ci j

33 INDUSTRIAL NUCLEAR ACTIVE Ir-192 120C1 702 RTS ACTIVE Ir-192 120C1 l

848 AMERSHAM INACTIVE Cs-137 30Ci, Yb-169 200Ci, Tm-170 SOCi, l

Ir-192 240Ci 866 AMERSHAM ACTIVE Cs-137 30 Ci, Yb-169 200Ci, Tm-170 SOCi, Ir-192 240Ci

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,7702 AMERSHAM INACTIVE Ir-192 120Ci i

87703 AMERSHAM ACTIVE Ir-192 120Ci 87704 AMERSHAM INACTIVE Ir-192 120Ci 88 INDUSTRIAL NUCLEAR ACTIVE IR-192 120CI i

89h1 AMERSHAM ACIVE IR-192 240CI l

89912 AMERSHAM ACTIVE IR-192 240CI 89913 AMERSHAM ACTIVE IR-192 240CI 89914 AMERSHAM ACTIVE IR-192 240CI 89916 AMERSHAM ACTIVE IR-192 240CI 89921 AMERSHAM ACTIVE IR-192 240CI 89922 AMERSHAM ACTIVE IR-192 240CI 83923 AMERSHAM ACTIVE IR-192 240CI e

9924 AMERSHAM ACTIVE IR-192 240CI l (

C0003 AMERSHAM ACTIVE Ir-192 240Ci

e IN 95-58 December 18, 1995 Page 4 of 8 i

11/21/95 n

List of Models That Meet 10 CFR Part 34 Requirements SOURCE (S) (continued)

Modnl Manufacturer Status Description 91810 AMERSHAM ACTIVE Yb-169 20Ci 91811 AMERSHAM ACTIVE Co-60 20C1 91812 AMERSHAM ACTIVE Tu-170 20Ci 91813 AMERSHAM ACTIVE Ir-192 20Ci 943 AMERSHAM ACTIVE Co-60 110Ci A424-1 AMERSHAM ACTIVE Co-60 220Ci, Yb-169 200Ci, Tm-170 50 Ci, Ir-192 240Ci

[

4-10 AMERSHAM ACTIVE Co-60 sci A424-11 AMERSHAM ACTIVE Co-60 SOCi A424-12 AMERSHAM ACTIVE Co-60 100Ci A424-13 AMERSHAM ACTIVE Co-60 330Ci A424-14 AMERSHAM ACTIVE Co-60 110Ci A424-15 AMERSHAM ACTIVE Co-60 lici A424-16 AMERSHAM ACTIVE Co-60 SOCi A424-17 AMERSHAM ACTIVE Co-6 SOCi A424-18 AMERSHAM ACTIVE Co-60 33Ci A424-19 AMERSHAM ACTIVE Co-60 120 mci A424-2 AMERSHAM ACTIVE Co-60 220Ci, Yb-169 200Ci, Tu-170 50Ci, Ir-192 240Ci A424-20 AMERSHAM ACTIVE Cs-137 30Ci, Yb-169 l

200C1, Tu-170 50Ci, Ir-192 240Ci i

IN 95-58 December 18, 1995 Page 5 of 8 4

4 11/21/95 List of Models That Meet 10 CFR Part 34 Requirements SOURCE (S) (continued)

M_o_d 31 Manufacturer Status Description A424-22 AMERSHAM ACTIVE Co-60 220Ci, Cs-137 10.8Ci, Yb-169 200Ci, Tm-170 SOCi, Ir-192 240Ci A424-3 AMERSHAM ACTIVE Co-60 220Ci, Yb-169 200Ci, Tm-170 SOCi, Ir-192 240Ci A424-4 AMERSHAM ACTIVE Co-60 220Ci, Yb-169 200Ci, Tm-170 SOCi, Ir-192 240Ci "t4-5 AMERSHAM ACTIVE Co-60 220Ci, Yb-169

(

200Ci, Tm-170 SOCi, Ir-192 240Ci A424-6 AMERSHAM ACTIVE Co-60 220Ci, Yb-169 200Ci, 1%-170 SOCi, Ir-192 240Ci A424-7 AMERSHAM ACTIVE Co-60 220Ci, Yb-169 200Ci, Tu-170 SOCi, Ir-192 240Ci A424-8 AMERSHAM ACTIVE Co-60.220Ci, Yb-169 200Ci, Tu-170 50C1, Ir-192 240Ci A424-9 AMERSHAM ACTI'IE Co-60 220Ci, Cs-137 30Ci, Yb-169 200Ci, Ta-170 SOCi, Ir-192 240Ci A453-1 AMERSHAM ACTIVE Co-60 220Ci, Yb-169 200Ci, Tu-170 SOCi, Ir-192 MOCi

'53-2 AMERSHAM ACTIVE Co-60 220Ci, Yb-169 g

200C1, Tu-170 SOCi, Ir-192 240Ci

IN 95-58 Deced er 18, 1995 Page 6 of 8 i

11/21/95 List of Models That Meet 10 CFR Part 34 Requirements SOURCE (S) (continued)

' Mod 71 Manufacturer Status Description A58101-8 AMERSHAM ACTIVE Ir-192 240Ci C-16F SPEC ACTIVE Ir-192 100CI E-16T SPEC ACTIVE Ir-192 100Ci C-990 NORDION ACTIVE Ir-192 140Ci G-11F SPEC UNKNOWN G-13F SPEC UNKNOWN G-15F SPEC UNKNOWN G-17F SPEC UNKNOWN l

G-19F SPEC ACTIVE Co-60 110Ci

[

F SPEC ACTIVE Ir-192 240Ci G-1T SPEC UNKNOWN G-21F SPEC ACTIVE Co-60 110Ci G-23 SPEC ACTIVE Ir-192 240Ci G-36 SPEC ACTIVE Ir-192 240Ci G-37F SPEC ACTIVE Co-60 110Ci G-38 SPEC ACTIVE Ir-192 240Ci C-3F SPEC ACTIVE Ir-192 240Ci G-40F SPEC ACTIVE Ir-192 240Ci G-40T SPEC ACTIVE Ir-192 240Ci I C-41.F SPEC ACTIVE Ir-192 240Ci C-41T SPEC ACTIVE' Ir-192 240Ci G-42.

SPEC UNfWOWN 0-MOF SPEC UNKNOWN

(

4 SPEC UNKNOWN L

.0 SPEC ACTIVE Ir-192 240Ci

f.

IN 95-58 i

December 18, 1995 Page 7 of 8 k-

11/21/95 List of Models That Meet 10 CFR Part 34 Requirements SOURCE (S) (continued)

Modql Manufacturer Status Description G-9F SPEC UNKNOWN N-23 SPEC INACTIVE Ir-192 100Ci T-1 SPEC ACTIVE Ir-192 140Ci T-1F SPEC ACTIVE Ir-192 140Ci T-2F SPEC INACTIVE Ir-192 140Ci T-5 SPEC ACTIVE Ir-192 140Ci T-5F SPEC ACTIVE Ir-192 140Ci

"-6 SPEC ACTIVE Ir-192 140Ci

. 7F SPEC INACTIVE Ir-192 140Ci CHANGER (S)

Mod ^.1 Manufacturer Stctus Description 500-SU AMERSHAM INACTIVE IR-192 120CI, DU 18 KG 650L AMERSHAM ACTIVE IR192 240CI,CO60 120 MCI,CS137 10.8CI,YB169 40CI,TM170 400CI, DU 42 LBS 770 AMERSHAM ACTIVE CO-60 550CI, DU 161 KG 771 AMERSHAM ACTIVE CO,-60 110CI, DU 97 KG

(

3 AMER 3 HAM ACTIVE Ir-192 1000C1, DU 100 kg

IN 95-58 December 18, 1995 Page 8 of 8

\\

11/21/95 List of Models That Meet 10 CFR Part 34 Requirements CHANGER (S) (continued)

Mod 91 Manufacturer Status Description 850 AMERSHAM ACTIVE IR-192 24OCI, DU'22 KG 855 AMERSHAM ACTIVE IR-192 960CI, DU 57 KG C-1 SPEC ACTIVE IR-192 100CI, DU 17KG

)

l 6

IN 95-58 December 18, 1995 Page 1 of 1 k'

LIST OF RECENTLY ISSUED NMSS INFORMATION NOTICES Information Date of Notice No.

Subject Issuance Issued to 95-55 Handling Uncontained 12/6/95 All Uranium Recovery Yellowcake Outside of a Licensees.

Facility Processing Circuit j

95-51 Recent Incidents Involving 10/27/95 All material and fuel cycle Potential Loss of Control licensees.

of Licensed Material 95-50 Safety Defect in Gammamed 10/30/95 All High Dose Rate 121 Bronchial Catheter Afterloader (HDR) Licensees.

Clamping Adapters 95-44 Ensuring Combatible Use of 09/26/95 All Radiography Licensees.

Drive Cables Incorporating Industrial Nuclear Company

(

Ball-type Male Conectors

. -39 Brachytherapy Incidents 09/19/95 All U.S. Nuclear Regulatory Involving Treatment Commission Medical i

Planning Errors Licensees.

95-29 Oversight of Design and 06/07/95 All holders of OLs or cps and Fabrication Activities for nuclear power reactors.

for Metal Components Used in Spent Fuel Dry Storage Independent spent fuel Systems storage installation designers and fabricators.

95-28 Emplacement of Support 06/05/95 All holders of OLs or cps Pads for Spent Fuel Dry for nuclear power reactors Storage Installatiras at Reactor Sites 95-25 Valve Failure during 05/11/95 All U.S. Nuclear Regulatory Patient Treatment with Commission Medical Gamma Stereotactic Licensees.

Radiosurgery Unit l

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\\ *s 7

IN 95-58 December 18, 1995 Page 1 of 1 LIST OF RECENTLY ISSUED f

NRC INFORMATION NOTICES Date of Issued to i

Infomation Issuance Notice No.

Subject l-All holders of Ols or cps Risk Impact Study Regarding 12/18/95 for nuclear power reactors.

l 95-57 Maintenance During low-Power Operation and Shutdown All holders of OLs or cps Shielding Deficiency in 12/11/95 for nuclear power reactors.

95-56 Spent Fuel Transfer Canal at a Boiling-Water _ Reactor 4

Handling Uncontained 12/06/95 All Uranium Recovery j

Licensees.

95-55 Yellowcake Outside of a Facility Processing l

Circuit All holders of OLs or cps l

95-54 Decay Heat Management 12/01/95 for nuclear power reactors.

Practices during Refueling Outages

.(

All holders of OLs or cps l

Failures of Main Steam 12/01/95 for nuclear power reactors.

95-53 isolation Valves as a Result of Sticking Solenoid Pilot Valves All holders of OLs or cps Unexpected Opening of a 11/30/95 for nuclear power reactors.

95-47, Safety / Relief Valve and Rev. 1 Complications Involving Suppression Pool Cooling Strainer Blockage All holders of Ots or cps Control and Oversight of 11/28/95 for nuclear power reactors.

94-13, Supp. 2 Contractors during Re-fueling Activities and Clarificaiton of Applica-bility of Section 50.120 of Title 10 of The Code of Federal Regulations to Contractor Personnel f

OL = Operating License CP - Construction Pemit

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?gmgg UNITED STATES Y

S NUCLEAR REGULATORY COMMISSION k

f WASHINGTON, D.C. 20555 4 001 1

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November 20, 1995 R.D. Dicharry Source Production & Equipment Co., Inc.

113 Teal street St Rose, LA 70087-9691

Dear Mr. Dicharry:

This is in response to your letter dated August 3,1995.

In your letter you requested clarification of several items relating to industrial radiography.

In order that we may provide prompt feedback to some of your concerns, I have provided responses to those questions (numbers 1, 2, 3, 5 and 8) that I can answer.

I am forwarding the remainder of the questions, which deal primarily with licensing issues, to Pat Santiago of the Commercial Section.

For matters related to these questions, please call her at (301) 415-7269.

1. Associated Eauipment Use Authorization Control assemblies that meet the ANSI N432-1980 and 10 CFR 34.20 equipment requirements when tested with one camera are not allowed to be used with another camera unless they have either passed the appropriate tests, have been shown through engineering analysis that they would likely meet the test requirements, or have been granted a license exemption.

In all cases, before the equipment is allowed to be used, it must have been deemed acceptable for licensing purposes by a regulatory authority (i.e., NRC or Agreement State).

2. Associated Eauipment Reaistration Reauirements The associated equipment must be registered for use with the radiography camera, or have been granted a license exemption.

In order for the component to be registered, it must have passed the requirements of ANSI N432-1980 and 10 CFR 34.20 or have been shown to meet these requirements by engineering analysis.

The licensee / user is ultimately responsible for ensuring that their radiography equipment has met the appropriate requirements or has been granted a license exemption.

10 CFR Part 34 is a user based regulation and 10 CFR 30.32, " Application for specific licenses", states under paragraph (g), that the applicant (licensee) is required to identify the source or device as registered by the Commission or an Agreement State, or submit the information identified in 10 CFR 32.210(c).

In many cases, for efficiency and convenience, the manufacturer, not the licensee requesting use of the device, submits the information to register the equipment. This is an acceptable pra tice as codified in 10 CFR Part 32.210.

During the registration process, as part of the safety evaluation, reviewers ensure that the product (s) meet all applicable regulations.

This includes 10 ENCLOSURE 2

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i Mr. R. D. Dicharry CFR 34.20, and 10 CFR 32.210.

In accordance with 10 CFR 32.210(c), "The request for review of a sealed source or device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property." Once the safety review has been completed and the product is deemed acceptable for licensing purposes, a registration certificate is

. issued.

Users of foreign manufactured associated equipment are only authorized to use the associated equipment if a regulatory authority has deemed the equipment acceptable for licensing purposes as indicated on a registration certificate or by a license exemption.

If the equipment has not been registered or granted an exemption, then the licensee requesting use of the product must t =gister the product with the appropriate licensing authority.

If the

.pplicant is located in an Agreement State, then the licensee needs to submit

he request for a safety evaluation to that state.

If the applicant is located in NRC jurisdiction, then the licensee needs to submit the request for a safety evaluation to the NRC.

3. Associated Eauipment Labelino Our policy has been that all associated equipment used in radiography equipment that has an effect on the overall safety / integrity of the camera or changer needs to be labeled and in such a manner that the label can not be easily removed.

The associated equipment includes the guide tubes (including "J" or similar type guide tubes), control tubes, control cables, and collimators that could come in contact with the scaled source.

By labeling the component, the manufacturer and/or licensee indicates that this component is expected to pass the equipment requirements in ANSI N432-1980 and 10 CFR 34.20 and that a prototype component built to the same specifications has been subjected to the equipment tests and passed these tests.

It is up to the manufacturer as to the label content (i.e., company logo, model number, etc.).

The location of the label shall be such that the component cannot be modified without indication that the component has been modified.

Information on labeling of components is typically found in the labeling section of the associated camera's registration certificate.

For example, the connectors on the guide tube are required to pass the tensile test described in ANSI N432-1980.

Our policy is that this component is to be labeled, and by labeling the manufacturer / licensee is indicating that this component is identical to one that has passed the equipment tests and for which a safety evaluation has been performed.

One way to label this component, so that any modification of the guide tube is noticeable, is to label the connectors themselves.

In order to change the length of the guide tube, a connector has to be removed, and then other connections added.

Unless the manufactured provided these connectors (assuming that the modification has

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i Mr. R. D. Dicharry been approved) a different connector would have to be installed. This would be an indication to an inspector that the guide tube is not authorized for use since the new connectors would not be properly labeled.

If manufacturers or distributors of associated equipment want their components approved for use, they must provide to the appropriate licensing authority the information necessary as outlined in 10 CFR 32.210 and to perform a safety evaluation.

If the associated equipment is deemed acceptable for licensing purposes, a registration certificate or similar document stating that this component is approved for use with specified radiography equipment will be generated. This document will be forwarded to the applicant and to the appropriate person (s) in NRC regional offices and Agreement States and any other concerned parties, as necessary.

4. Quality Control Reauirements Manufacturers of associated equipment must meet the requirements and all necessary testing stated in ANSI N432-1980 and 10 CFR 34.20.

In addition, they must meet the requirements in 10 CFR 32.210, which includes a review of their quality control program.

5. Source Chanaer and Source Compatibility The application process to verify that one manuf acturer's source model is compatible for use in another manufacturer's source changer is similar to the process we use to verify that one manufacturer's source is compatible for use in another manufacturer's camera.

Either the manufacturer of the source or chaager, or the applicant which requests use of the combination can submit the application for safety evaluation.

In all cases, our safety evaluation review is the same.

We review and analyze the information as required by 10 CFR 32.210, 10 CFR 34.20, and the ANSI N432-1980 to ensure that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

For your particular concern, of how we verify that one manufacturer's source is compatible for use in another manufacturer's source changer, I have summarized the basic procedures below.

1)

Get drawings, including tolerances, of the changer and sealed Source.

2)

Compare dimensions to ensure that the components are compatible when they are manufactured within tolerance.

Mr. R. D. Dicharry 3) Verify that prototype has passed all necessary tests (ANSI,10 CFR 34.20).

In lieu of actual tests, if a substantially similar component has passed the appropriate tests, engineering analysis may be used.

4) Verify that the radiation levels are within acceptable limits.

5) Verify that the locking mechanism will work properly with the sealed sourCO.

Your questions refer to current policy decisions that affect all manufacturers and distributors of radiography equipment.

Therefore, I am forwarding copies of this letter and your August 30, 1995, letter to other manufacturers of radiography equipment for their information and use.

"C'krialSignedBy:

StevenLBaggett Steven L. Baggett, Section Leader Sealed Source Safety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Attachment:

SPEC letter dated August 30, 1995 cc:

K. Roughan, Amersham B. Huddleson, INC J. Munroe, RTS J. Stirling, Nordion B. Spell, State of CA E. Bailey, State of CA 4

DISTRIBUTION:

SCDB r/f IMNS Central Files NMSS r/f P. Lohaus L. Bolling P. Santiago B. Carrico R. Chappell R. O'Connell F. Combs SSSS Staff R. Baer NE02-SSD-7 M. Schwartz S. Treby D. Cool DOCUMENT NAME:

G:\\SSDS\\DICHARY.CLR To,oceive a copy of 18de document, lad 6cate in the boa: "C* = Copy w6thout attachment / enclosure

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Mr. R. D. Dicharry 3) Verify that prototype has passed all necessary tests (ANSI,10 CFR 34.20).

In lieu of actual tests, if a substantially similar component has passed the appropriate tests, engineering analysis may be used.

4) Verify that the radiation levels are within acceptable limits.

5) Verify that the locking mechanism will work properly with the sealed source.

Your questions refer to current policy decisions that affect all manufacturers and distributors of radiography equipment.

Therefore, I am forwarding copies of this letter and your August 30, 1995, letter to other manufacturers of radiography equipment for their information and use.

SI"C'"dtldrialSignedBy:

i StevenLBaggett Steven L. Baggett, Section Leader Sealed Source Safety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Attachment:

SPEC letter dated August 30, 1995 cc:

K. Roughan, Amersham B. Huddleson, INC J. Munroe, RTS J. Stirling, Nordion B. Spell, State of CA E. Bailey, State of CA 1

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t Qy 0-August 3,1995 Mr. Steven Baggett, Section Leader Scaled Source Safety Section Source Containment and Devices Branch Division ofIndustrial and medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

. U. S. Nuclear Regulatory Commission Washington, D. C. 2055561

Subject:

Clarification of Radiography Equipment Requirements

Dear Steve:

The gxupose of this generic letter is to request clarification of the regulatory requirements regarding the authonzation and use ofindustrial radiography equipment. Bruce Carrico has already responded to some questions last June regarding license amendment requirements for radiography licensees to use the model SPEC-150 exposure device. I am pleased to report that the first NRC license amemiment for the SPEC-150 was issued since then. It is good to see that the list of authorized model numbers in Items 6 and 9 of a user's NRC Materials license have been replaced with a reference to the authorizing regulation. I was concerned that 10 CFR 32.210 might not be applicable since it applies to manufacturers that distribute products to exempt parties and general licensees.

In order to provide accurate license amendment information to NRC licensed users to use the SPEC-150 would you please clarify the following points. I realize that the requirements might be different in agreement states dependmg on the division level ofcompatibility. I explored some ofthese questions a few years ago without resolution, so I will not be surprised if they take some time to unravel. Please do not think that I expect quick answers to them.

1. ASSOCIATED EQUIPMENT USE AUTHORIZATION Are ticeamt users authorized to use other manufacturers' associated equipment, pnmarily control assemblics, with the SPEC-150? Each model camera in the United States requires considerably different amounts of foiec to operate (perhaps as much as 3x greater force over the range ofcameras),

and each model control assembly generates considerably different amounts of force. Therefore, is a coutml assembly that meets the ANSI N432-1980 and 10 CFR 34.20 requirements when tested with one camera automatically qualified to be used with another model camera that it has not been tested with?

2. ASSOCIATEDEQUIPMENTREGISTRATIONREQUIREMENTS Iflicensed users are authorized to use other manufacturers' aswh'ed equipment with the SPEC-150, what are the registration requirements and who is required to submit the appliesti= the manufacturer or the user? We feel that associated equipment marnifactured by other parties should be tested with the SPEC-150 to verify that it meets ANSI N432-1980, especially the 20,000 cycle endurance test g with SPECS torque specification. Fabrication should be controlled by an approved

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l quality assurance program. Licensed users should be able to use other manufacturers' associated equipment with the SPEC-150 exposure device providing they are authorized by the NRC. Are l

! baaed users of the SPEC-150 required to submit foreign manufactured associated eqinipment to the NRC for approval?

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3. ASSOCIATEDEQUIPMENTLABELING

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What are the regulatory reqibucsts regarding labeling ofnaaachied equipment that is m=ireti-ed by other parties to verify that it meets ANSI N432-19807 We descritm the labeling of our associated equipment in the SS&D applicatiort However, some associated equipment manufacturers do not manufacture sources and devices; therefore, they do not submit SS&D applications. Are licensed users required to have only associated equipment that is labeled?

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4. ASSOCIATED EQUIPMENTREPAIR Arc licensed users authonzed to salvage and assemble components ofvarious manufacturers' control assemblies to repair a SPEC control assembly? Are they required to venfy that the new design meets the ANSI N432-1980 test requirements and 10 CFR 34.207 Finally, are there additional labeling requirements for " composite" Waud equipment?

5. QUALITY CONTROLREQUIREMENTS l

What are the requirements, if any, that manufacturers of associated equipment (i.e., control

====ahl% guide tubes and collunarnrs) must meet to distribute to users of the SPEC-150? Are they required to test their equipment with the radiography system in acceidescc with ANSI N432-1980, I

and are there any quality control requirements?

6. SAFETY INSPECTION AND MAINTENANCE Are NRC licensed users required to adopt the manufacturer's safety inspection and mainte. nance instructions? 'Ihis is a very common and signi6e=ar question. Part 32.210(c) requires infonnation from the n=nfachmer aboot service and maintenance of the device. That infonnation is included in the SS&D registrabon application and is also reflected in the SPEC-150 User's Manual. Licensed users are required pursuant to 10 CIR 34.28(b) to conduct a quartedy inspection and mai*nanm program, but the mai* nance program requitancets are not ap~ ined We prefer users to voluntanly adopt our ia a~ don and mainimane instructions, but it does not appear to be a regulatory requirement for them to do so. Manur=*=er's instructions regarding the Regi~ecy of maintenance and restrictions against unamharimd repairs are vay important. We feelthat use 3 should not be required to adopt our recc-s.= *.rions as long as they have a comparable alternate program. Is NRC awhari=* ion required for liccased users to adopt an attemate program?

7. DEVICE REPAIR Repair ofexposure devices is not speci6cally addressed in 10 CFR 34.20, so this might be out ofyour scope. I have asked SCDB to clarify the re,J.;; cad user's authorization to perform repairs (as opposed to maimemam) to Type B packages. "Ihe answer could have an impact on firmard uscus authorization l

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@0 to repair radiography devices that are also a Type B package.

8. SOURCE CHANGER AND SOURCE COMPATIBILITY What is the application process to verify that one manufacturer's source model is compatible for use in another manufacture /s source changer? Which manufacturer must submit the application?

SUMMARY

I imagine that all manufacturers have a strong interest in these questions. The interpretation of the regulations could have a significant financial impact. Obviously, no manufacturer wants to suffer a ce5+utive disadvantage if regulatory requirements are applied unevenly among various types of domestic and foreign manufacm=crs. However, our greatest concern is the civil liability that results from insuries to workers due to Spred malfunctions. We have never lost a suit nor have we ever W out ofcourt, but the legal expense we have suffered is enonnous. Injuries that are caused by other manufacturers associated equipment that are used with SPEC exposure devices and sources subjects us, the proverbial " deep pockets," to litigation even when our products are not defective. ' Ibis is the greatest threat to SPEC. With a clear understanding of the regulations we can assist radiography licensees to use and operate our equipment in a safe manner.

1 I will be happy to visit with you and your staff to discuss this further. Thank you very much for your assistance.

S' I-

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R. D. (Donny) Dic President l

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Bill Spell i

1 08-02-95.GCl

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TASK # - SS320 DATE-11/17/95 MAIL CTRL. - 1995 TASK STARTED - 11/17/95 TASK DUE - 11/30/95 TASK COMPLETED -

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