ML20055J044

Suggests That Fr Notice,Page 23,Part B Include 7.Type of Personnel Involved in Each Incident, Per Document Re Safety Requirements for Industrial Radiographic Exposure Devices

ML20055J044
Person / Time
Issue date:	01/13/1989
From:	Novak T NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:	Roecklein A NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
Shared Package
ML20055H979	List: ML20055H978 ML20055H984 ML20055H993 ML20055H999 ML20055J009 ML20055J015 ML20055J017 ML20055J022 ML20055J030 ML20055J032 ML20055J034 ML20055J035 ML20055J036 ML20055J037 ML20055J038 ML20055J039 ML20055J040 ML20055J041 ML20055J042 ML20055J043 ML20055J044
References
FRN-55FR843, FRN-55FR8460, RULE-PR-34 AC12-2-24, NUDOCS 9007310309
Download: ML20055J044 (64)

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UNITED STATES E

NUCLEAR REGULATORY COMMISSION -

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pu January 13, 1939 f)%

i HEMORANDUM FOR:

A. K. Roechlein, Acting Chief-Radiation Protection and Health Effects Branch Division of Regulatory Applications, RES FRON:

Thomas M. Nevak, Director Division of Safety Programs, AE00

SUBJECT:

SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC EXPOSURE DEVICES We have reviewed the subject document and we suggest that the Federal Register Notice, page 23, Part b,-should include the following additionai item:

"7.-Type of personne involved in each incident."

We appreciate ~ the o.pportunity to connent on the subject document.

Ib"I#

b. I. 3 'l W

Thomas M. Novak, Director

, Division of Safoty Programs, AE00 4

g73g309900726 34 55FRB43 PI,

AC /2 - 3.

Pae este ROUTING AND TRANSWTTAL SUP 12/28/88 nw. me= emmen.

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me.so m er/ Post) 4eoner 3.

F.J. Congel, NRR.

g, R.E. Cunningham, NMSS

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C.C. Kamerer, GPA 8,

M.C. Malsch, OGC.

4, T.M. Novak. AEOD.

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Action Fue note end natum

]Repreel For Closeense Mr Convueetten As Reevested For Correction Prope m Reely Direutete For Veer infeenotten See Me

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agMAnas SUBJECT ~

Safety. RequiremIents 'for Industrial Radiographic Exnosure Devices; t

L Please review and-coment on' the enclosed documents. and provide me with your connents by January 18, 1989.

ENCLOSURES:

1 Comission Paper-Federal Register Notice Analysis of Coments Do NOT use this form os e Rt00Ro et approvels, consveronese, dispeesle, elearonees, and simlier estione PROM:(Name,

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Room No -414 Acting: Chief A.K. Roe lein, Phone Ms.

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ANALYSIS OF COMMENTS 1

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-1 ANALYSIS OF COMMENTS =

i IDENTITY OF COPHENTERS Doe!.et File Commenter Number Comenter

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1 State of California (Div.of,OccupationalSafety8. Health)

Van Nuys.-CA-q 2-MQS Inspection Inc.

I Hartford, CT 1

3 Liberty Mutual =

Hopkinto,, MA.-

4 MQS Inspection, Inc.

Hartford, CT 5

NDTMA Bethel Island, CA 6

AmericonHoldingCompan/,Inc.

Copley, OH 7

MQS Inspection sinc.

Hartford, CT 8

Consumars Power Jackson.-MI 9

NDTMA Bethel Island, CA 10 Riley-Beaird Inc.

Shreveport LA 11 Amersham Corporation Burlington, MA 12 ASNT Columbus 'OH 13 Edwards Pipeline Testing Inc.

', ~

Tulsa, OK

~14 Combustion Engineering Windsor.-CT ft1

.. ~.. -. -

ANALYSIS OF CO M ENTS (Continued).

IDENTITY OF CGMMENTERS Docket File Commenter Number Comenter 15 MQS Inspection. Inc.

l Elk Grove Village,'IL 16 Westinghouse Electric Corporation Pittsburgh, PA 17 Empire Steel Castings.-Inc.

Reading, PA l

10 Amersham Corporation Arlington Heights, IL-19 Industrial NDT Company, Inc.

North Charleston, SC j

20 MQS Inspection. Inc.

Hartford, CT.

. i i

i 21 Texas Department of Health Austin, TX 22.

Bethlehem Steel Corpora' tion =

Bethlehem, PA 23 Air Transport Association Washington, DC 24 NDTMA Bethel Island, CA l

25.

NDTMA Bethel Island,.CA 26 Carolina Power & Light Co.

Raleigh, NC 27 Duke Power Co.

Charlotte, NC 28 Department of the' Navy Washington, DC e

29 Richardson X-Ray, Inc.

Alhambra CA.

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I ANALYSIS OF ComENTS-(Continued)

IDENTITY OF COMMENTERS i

~ Docket File Commenter Number Commenter 30 Tech /0PS. Inc.

Boston, MA t

31 MQS Inspection,'Inc..

Roseville, MN 32 Globe X-Ray Services; Tulsa, OK 4

e 33 Ultrasonic Specialists, Inc.

l Houston, TX 34 Connex Pipe SysteG Marietta, OH 35 Harrison Steel Castings, Co.

Attica, IN

+

36 Mason & Hanger-Silas Mason Co.,'Inc.

Middletown IA-a 37

-Northwest Testing Laboratories,'Inc.

Portland, OR i

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38 NASA d

Kennedy Space Center, FL 1

39 Florida Power-Corporation-1 Crystal River, FL '

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40

. Keokuk' Steel Castings, Inc.

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Keokuk.IA' 41 Mobile Inspection Service, Inc.

Santa Fe Springs, CA 1

4 42 North American Testing Co., Inc.

Maryland Heights, M0 43 Mason & Hanger-Silas" Mason Co., Inc.

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Amarillo, TX 4

44 Newport News Shipbuilding Newport News, VA 3

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ANALYS15DF.ComENTS(Continued)

IDENTITY OF CDP 94 ENTERS Docket File L

Comenter Number

' Comenter

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45 Eastern Idaho Vocational-Technical l

School Idaho Falls, ID-46 Grove Valve & Regulator Co.

Oakland, CA 47 X-Ray Inc.

Seattle..WA 48

_ MQS Inspection, Inc.

Indianapolis, IN 49 John Deere Foundry East Moline East Moline, IL

't 50 Larry Van' Fleet Richland, WA-51 Electro Alloys, Inc.

52 E. Lewis Cook-& Associates-i Chattanooga, TN 53 Department of the' Air Force Kelly AFB, TX l

Pensacola Testing Laboratories. Inc.

54 l

Pensacola, FL 55 Duplicate of.54 56 U.S. Nuclear Regulatory Comission:

l Region'I King of Prussia..PA 57 George M. Corney Hilton, NY 58 Riley-Beaird.-Inc.

Shreveport, LA.

59 Litton, ingalls Shipbuilding

.Pascagoula,~MS 1

3

-- -. a.

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[

ANALYSIS OF COMMENTS (Continued)

IDENTITY OF'COMMENTF h Docket File

. Comenter

- Number Commenter 60 Industrial NDT Services Isdianapolis, IN 61 No Identifiction 4

62:

Duplicate of 32 63 L.H. Sherwin Cincinnati. 0H 64 Department of the Air Force Bolling AFB ~ DC 65 Capital.X-Ray Services Inc.

Tulsa,.OK 66 Union Carbide: Corporation North Kansas City, M0'

^

67 American Airlines Tulsa, LOK' l

68 A.'Santascelli Burke, VA' 69 Quad City Testing Labor'atory, Inc.

. Devenport I A ~

70

. Fabrication Inspection Services Harvey, LA 71 MQS Inspection. Inc.

Rosev111e', MN-72 Edwards Pipeline. Testing. Inc.

Tulsa,'0K i

73-Professional Welding Associates. Inc.

l Kewaunee, WI

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74 Emar En'tersrises L

El~ Cajon

A i

l 75 Joseph:F. Bush Avondale' Industries, Inc.

New Orleans, LA 15 1

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i ANALYSISOFCO>NENTSL(Continued)

IDENTITY OF COMMENTERS

- Dor.ket File

' Commenter' Number:

Commenter 76 Boeing Commerciai Airplane Co.

1 Seattle, WA 77 Tenneco Gas Transportation Houston, TX j

78 Alabama Power Mobile, AL 79.

Central Testing Co., Inc.

I Lake Charles, LA

.t 80 ASNT(Survey) a Columbus, OH 81 George R. Henke Napa CA 82 Arrow NDE-Company, Inc..

Breken Arrow, OK 83 ComLustion Engineering. Inc.

Wind. tor, CT q

84 Air Transport Association l

Washiagton, DC

.l

'^

85' Rockwell. International Atchison, KS 86 Source Productica & Equipment Co., Inc.

St. Rose. LA a

87 No Identity Given Orlando, FL k

88 Teledyne.CAE Gainsville, FL' 89

-RTS Technology, Inc.

North Andover, MA 6

O DQ Document Name:

COMMENTS / ANALYSIS f!NAL RULE Requestor's 10:-

MENDIOLA Author's Name:

i DNellis Document Comments:

Part of a final rule package.

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ANALYSIS OF COMMENTS IDENTITY OF COMMENTERS Docket File Commen.er Number Comenter 1

State of California (Div.'ofOccupationalSafety8 Health)-

~

Van Nuys, LA 2

MQS Inspection, Inc.

Hartford, CT 3

Liberty Mutual Hopkinton,.MA' 4

MQS Inspection, Inc.

Hartford, CT S

NDTMA Bethel Island,;CA 6

AmericonHoldingCompanyiInc.:

Copley, OH 7

MQS Inspection, Inc.

Hartford,'CT 8

Consumers Power 1

Jackson, MI-9 NDTMA Bethel Island, CA-t

-10 Riley-Beaird,.Inc.

Shreveport, LA 11 Amersham Corporation-Burlington, MA 12 ASNT Columbus, OH 13 Edwards Pipeline Testing, Inc.

Tulsa, OK-

.I 4 --

' Combustion Engineering Windsor, CT j

ANALYSISOFCOMMENTS(Continued)

IDENTITY OF COMMENTERS Docket Jile Comenter i

humber Comenter i

15 MQS Inspection, Inc.

Elk-Grove Village. IL.

16 Westinghouse Ele'etric: Corporation Pittsburgh,~PA~

17 Empire Steel Castings, Inc..

t Reading, PA ID Amersham. Corporation Arlington ' Heights. IL 19 Industrial:NDT Company, Inc.

NorthfCharleston, SC-t 20 HQS' Inspection,Inc.

Hartford, CT-21 Texas Department of Health Austin, TX 22 Bethlehem Steel Corporation

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Bethlehem, PA-l 23 Air Transport Association Washington. DC 24 NDTMA Bethel Island, CA 2S NDTMA Bethel Island, CA 1

26 Carolina Power & Light Co.--

.Raleigh, NC 1

27

-Duke Power Co.

. Charlotte, NC--

s 28 Department of the Navy Washington, DC i

29 Richardsor:1-Ray, Inc.

Alhambra,:CA-l 2

[

ANALYSIS OF COMENTS (Continued) j IDENTITY OF COMMENTERS Docket File Commenter Number Commenter 30 Tech /0PS, Inc.

Boston, MAL 31 MQS Inspection, Inc.

Roseville, MN

~ lobe X-Ray Services

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32 G

Tulsa, OK

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33 Ultrasonic Specialists,.Inc.

Houston, TX 34 Connex Pipe Systems Marietta, OH

g 35 Harrison Steel-Castings, Co.-

Attica :IN 36 Mason & Hanger-Silas Mason Co.', Inc.

Middletown, IA 37 Northwest Testing Laboratories, Inc.

]

Portland, OR i

38 NASA

~ l Kennedy Space Center, FL 39 Florida Power Corporation-Crystal River, FL 40 Keokuk Steel Castings Inc.

Keokuk, IA 41 Mobile Inspection Service Inc.

Santa Fe Springs. CA 42 North American Testing Co., Inc.

~

Maryland Heights,-MO 43 Mason & Hanger-Silas' Mason Co., Inc.

Amarillo, TX 44 Newport News Shipbuilding Newport News, VA 3

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1 l

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ANALYSIS OF COMMENTS (Continued)

IDENTITY OF COMMENTERS Docket File-Comenter Number Comenter 1

45 Eastern Idaho Vocational-Tschnical School.

Idaho Falls, ID 46 Grove Valve & Regulator Co.

Oakland, CA-1 47 X-Ray-Inc.

Seattle, WA j

I 48 MQS Inspection,'Inc.

Indianapolis, IN 3

49

- John Deere Foundry East Moline

' East Moline. IL 1

50 Larry Van Fleet Richland, WA~

51 Electro Alloys. Inc.

E 52 Missing i

-i 53 Department of the Air Force Kelly AFB, TX

.i 54 Pensacola Testing Laboratories, Inc.

-I Pensacola 'FL

'i 55 Duplicate of 54 l

56 U.S. Nuclear Regulatory Comission.

'I Region I

' King of Prussia, PA 57 George M. Co;ney Hilton, NY 58 Riley-Beeird, Inc.

Shreveport, LA 59 Litton.-Ingalls Shipbuilding Pascagoula, MS 4-

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ANALYSIS OF COMMENTS (Continued)

IDENTITY OF COMMENTERS Docket File Commenter

i Number Commenter i

60 Industrial NDT Services Indianapolis, IN P

61 No Identifiction 62-Duplicate of 32 63 1L.H. Sherwin-

' Cincinnati, OH-

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(4 Department of the-Air Force-Bolling-AFB DC 65 Capital X-Ray Services. Inc.-

Tulsa,'0K'

-l 66 Union Carbide Corporation

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North Kansas City, MO a

67 American Airlines Tulsa, OK.

L 68 A. Santascelli Burke, VA 69 Quad City Testing Laboratory.. Inc.

Devenport, tI A:

70 Fabrication' Inspection Services Harvey, LA 71 MQSlInspectioneInc~.,

Roseville, MN 72 Edwards Pipeline Testing, Inc.

Tulsa,-0K 73 Professional Welding. Associates, Inc.

Kewaunee, WI

~

74 Emar ' Enterprises El Cajon, CA l

75 Joseph.F. Bush Avondale Industries Inc.

New Orleans, LA 5

J ANALYSIS OF COMMENTS (Continued)

IDENTITY OF COMMENTERS 1

Docket File Commenter Number Commenter-76 Boeing Connercial Airplane Co.

Seattle, WA-77 Tenneco Gas Transportation Houston, TX, 78' Alabama Power Mobile, AL 79 Central Testing Co., Inc..

Lake Charles, LA 80~

ASNT(Survey)

Columbus. 0H 81-George R; Henke Napa, CA 82 Arrow NDE Company, Inc..

Broken Arrow, OK.

83 Combustion Engineering, Inc.

Windsor, CT 84 Air Transport Association.

Washington, DC-85-Rockwell, International Atchison, KS 18 6 Source Production & Equipment Co'.

Inc.

St. Rose, LA i

87 No Identity.Given

-l Orlando.. FL.

88 Teledyne CAE Gainsville, FL 89 RTS Technology, Inc.

North Andover, MA 6

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ANALYSIS OF COMMENTS i

i SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC i

EQUIPMENT The NRC received a total'of 88 docketed comment letters and one telephone comment for a total of 89 commenters on the proposed rule, As indicated below,_

a breakdown of these letters resulted in a total of 68 net valid comment letters.

In addition to the comment l'etters discussed above, the AMERICAN SOCIETY FOR, NONDESTRUCTIVE TESTING. INC., (ASNT), a major trade organization which represents-'

l a significant number of radiographic equipment users, polled their membership using a survey questionnaire based on the proposed rule.- Responses to the ASNT survey amounted-to 399 out of the stated ASNT membership ofl7000, the majority of which are involved in alternate means of nondestructive testing that involve ultrasound, eddy currents, microwave techniques, ultra violet sensing and-others.

The replies and the analysis of the survey were recorded as docket number 80 in this docket.

l Because the form of the survey was a multiple choice assignment'with.three choices; AGREE, DISAGREE, NO OPINION, and since it did not track directly the issues addressed in the proposed rule, it was not~ included in the currentLanaly-sis of comments.

The results of the survey and the NRC assessment of what it infers are addressed'at the end of this analysis of comments.

BREAKDOWN OF COMMENTS i

Tota l re c e i v e d -------------------- ------------------- : 89 i

Comment on ano' rule ---------------- 4 Request for ext,.sion only ------------- 5 Duplicates --------------------------'---' 3 Survey letters without comments -------- 8 Request for copy of rule --------------- 1 21 i

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Net valid comment letters ------------------------------ 68 Additional ASNT survey responses --------------------- 399 4

GENERAL DISCUSSION 4

l The proposed rela contained issues expressed both in sections, such as' I

S34.20; paragraphs, such as $34.20 (c); and sub paragraphs, such as.634.20(c)

(3); all of which were open for discussion and comment.

This added to a total of 27 separate issues to be commented upon.

Most of the commenters did not j

make comments on cil of the issues but a brief review of the comment letters from many of the larger radiography firms' indicate that they responded to comments on at least 10 of the 27Eissues.

In addition commenters:provided a-number of additional comments or suggestions to the NRC on how to' improve:on -

radiography safety.

The following-analyzes each_of the 27 issues in order and-this.is then followed by a discussion of additional comments and the NRC response to each of them.-

1

i S 34.20(a) DEVICES MUST MEET REQUIREMENTS OF ANSI N432 Twenty four comments were received on this requilement, eleven or 46-percent i

approved and thirteen or 54 percent were opposed.- Principal comments were as

.-l follows:

APPROVED q

Commenter i

8 This requirement will make the equipment more reliable and safer to operate.

16 Approve of the requirement but request a formal administrative.

requirement for the NRC to notify its licensees of any changes in the consensus standard, in addition'to the~ Federal Register notice i

announcing the change.

Standard specifications are the b' sis for well constructed radiographic 18 a

equipment.

8 1

i-APPROVED-(Cont'd)

Commenter 30 Consensus standard assures practicability of the requirement.

86 Agree with all parts of.the standard except the requirement for section on radiation levels.

Y OPPOSED Commenter 21 :*

The radiation levels specified in the standard may prove.not to be cost effective.

Radiation levels on equipment have not been found to be a major contributor to exposure.

23 Opposed because the added shielding requirements would make existing devices obsolete after five years and impose a significant financial burden on users of current equipment.

~

64 The added shielding required to meet the-specified radiation would limit the portability of the devices.

1 75.

Opposed due to the cost of replacement devices.;

79 Opposed to all the changes required by the standard until the NRC conducts a survey to show that the proposed changes will make overexposures non-existent.

I 82 Finds it unbelievable that'the only inferred concept to _ reduce radia-tion levels is to trash current devices.

Not only is"this very.

expensive but present carrying times are of the order of four minutes per day and the device is seldom in contact with the leg or other parts of the body.

The devices currently weigh in the order of forty pounds and additional shielding will result in havinc to carry the device longer a:id closer to the body.

9

1.

OPPOSED'(Cont'd)

I l

Commenter 88 i

Feels that the conditions of the standard should be restricted to field device use only.

Staff Response:

The principal objection to adoption of this provision appears to be'the added shielding needed to meet the-radiation levels specified-in the' standard ANSI N432.

Commenters should be aware that the existing radiation level limits were established when lead was the commonly used s11elding material and radio '

graphic exposure dev'ces measured four inches or mot' from the source to the outside of the device.

With the use of depleted uraniim. shielding beginning in the mid sixties it was possible to meet'the existing Madiation. levels with devices that measured around two inches from source to sur' ace of the device.

This can lead to surface levels of about 800 mR/hr.- Independent studies made in France and the United States indicate that the annual dose to the thigh from carrying radiography devices increased from 5.4 R for the older and larger-devices to 11.5'R for the newer smaller devices.

1 l.

Studies such as the above are the probable basis'for'the levels specified in ANSI N432.

It should be pointed out that the levels specified in.the stan-l dard were published in 1981, that identical levels have been a part of the l

international standard since 1977, and that'the radiography industry has not been unaware of the new requirements.

The fact that several radiographic exposure j

devices now on the market can meet the new-radiation levels and still be port-able seems to refute the argument of many of the commenters.

The staff also see no reason to restrict the requirements of the standard to-field devices

.p'articularly since the standard applies to portable, mobile, and fixed exposure j

devices.

The staff see no reason to make any changes in this provision.

l 6 34.20(b)(1) EXPOSURE DEVICE LABEL t

A total of fourteen comments were received on this issue, all but two

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approved.

The negative comments indicated that the markings should be such that

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they cannot be mutilated beyond identification and that the upkeep of proper markings could be costly.

The cther comment was that the isotope manufacturer must be responsible to provide 16 custoiner with the proper label and that guidelines should be prepared to specify lebel dimensions and method of attach-ment to allow device manufacturers a stcadard for design specifications.

Staff Response:

Current industry practice is for the manufacturer to provide a plate to the exposure device user with the source changer and new source.

The standard does however provide that the device have a location for attaching this plate (see 4.2).

It is the responsibility of the device user to attach the plate.

The provision will stand as proposed except one additional item, the name, address and telephone number of the owner will be included on the label.

It is the responsibility of the user to keep this i: formation current.

S 34.20(b)(2) REQUIREMENT TO MEET 10 CFR PART 71 S 34.20(b)(3) MODIFICATIONS NOT TO COMPROMISE SAFETY No negative responses were received for either o'f these two issues.

One manufacturer however c;uestioned in whose judgment would modifications ifect system design and safety.

The manufacturer also asked if this implies that no modifications may be made without resubmission of designs to the proper NRC or l

Agreement state authority.

Staff Response:

l j

No changes are to be made in S 34.20(b)(2).

In regard to the comment concerning modifications, the intent of this provision is to prohibit users from making modifications that could compromise the safety of the device.

The provi-sion is not intended to impose design restrictions on manufacturers.

No changes-are to be made in S 34.20(b)(3).

S 34.20(c)(1) SOURCE ASSEMBLY-CONTROL CABLE CONNECTION Twenty two comments were received on thu requirement.

Fifteen, or 68 percent of the commenters approved and seven, o.' 32 percent were opposed.

The principal comments were as follows:

11

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APPROVED 1

Commenter 7

Approve but recommend that whatever coupling is adopted that it be i

made mandatory and standardized to the point of interchangeability regardless of the manufacturer.

This concept of-interchangeability should also be extended to apply to all components that attach to

.the exposure devices.

18 Approve in principle but feel that the wording in the Texas regulations l

is more appropriate.

19 An improved standardized design should greatly reduce inacvertent i

overexposures.

Suggests going even further--- _ eliminate pigtails.

This would be the single best safety improvement of all~those proposed.

(Note that at'least one device now in use has no pigtail.)

30 Approve but feel the wording should state that a positive force is needed to produce a disconnect.

88 Agree in principle,-but the wopding is not'too clear.

Prefers the screw type connector with a lock.

('

89 Might be improved by following the State of Texas wording which emphasizes an application oriented approach as opposed to an engineer-ing approach; this would allow future. designs and. approaches for i

abnormal situations.

k OPPOSED Commenter 1

21 Don't like the wording.

Suggest that we change from technical specifications to performance requirements.

L 1

.i OPPOSED-(Cont'd) i Commenter, 42 Unsure of the meaning or which connectors would be accepted.

)

63 The wording is ambiguous.

Also, it should be specified that a=pcsitive force is required for a disconnect.

Suggests that wording might specify motion.in two orthogonal directions.

64 This would require moving parts'that could fail.

i 65 The language is too restrictive.

'~

74

. Feels that disconnects will occur even in fail-safe devices.

Staff Response

.1.

Staff agrees that the wording should be changed to reflect more of.a performance oriented approach.

The' suggestion has been adopted and the wording changed.

6 34.20(c)(2) SOURCE POSITION INDICATOR Forty-two comments were received on this requirement. 'Four,.or 10 percent of;the commenters approved and thirty-eight, or-90 percent were. opposed.

The principal comments were as follows:

APPROVED L

Comme.er i.

7 Should be on all cameras but with the understanding that it is only-L a guide.

l 13

OPPOSEO 1

Commenter i

Experience has shown that they are not reliable.-

8 10 Not needed, if. survey meter is used.

13 Could lead to false indicat.fons.

The additional parts needed could fail.

i 18 May be an additional guide but it can also. fail. : Don't think there

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are adequate statistics to show-that it increases safety.

19 Those in use have not proven to be fail-safe.

Retrofitted ones could be worse.

22

-Should not be required even though the idea is good, --

radiographers won't use survey meters.

29 May result in negative impact as radiographers may rely on indicator instead of survey meter.

30 Note that the indicator only indicates the position of the pigtail..

If the source falls off._the pigtail the indicator, is of no use.

32 Do not-think it.will improve safety.

33 Would be a disao' vantage at the present time --- a crutch to use instead of a survey meter.

38 o'

Good idea but it should be emphasized that it is only an. additional indicator.

40 Impractical in a permanent installation.

42 Have an extremely negative feeling towards.

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OPPOSED (Cont'd)

J 1

Commenter F

49 We have one, --- it is not 100 percent accurate and also needs maintenance.

59 OK if a foolproof and easily visible one can be designed.

60 Unreasonable,-will malfunction and be expensive.

67-

• J Should postpone this requirement until data are acquired to show how it will improve safety.

79 Keep cameras simple.

81 Generally negative about all additions to cameras..

Staff Position This particular item has long been controversial.

At a 1978 NRC meeting convened to discuss the design of radiographic exposure devices, it was gener-ally agreed:that-it was not'possible to design a position indicator that' could l

not fall.- It was also pointed out at-this' meeting'that source position indi-1 l

cators consisting of red and green' lights were installed on some devices as.

l' early as 1958.

These failed so frequently that'the NRC asked manufacturers 1to

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remove them.

Also, a provision for such an indicator has been proposed,for inclusion in the next revision of the International Radiography Standard, ISO q

3999, by the French delegation but there appears to be.little support from other l>

countries.

In view of the continued oppostion and past experience with these L

indicators the staff have agreed to remove the provision.

E S 34.20(c)(3) _ AUTOMATIC SFUf:ING OF SOURCE ASSEMBLY Thirty-two comments were received on '".s requirement.

Seven, or 22 i

percant of the commenters approved and tw;nty-five, or 78 percent were opposed.

'The principal comments were as follows:

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APPROVED

]

Commenter 7

This feature should have been made mandatory a long time ago.

Devices without this feature should be recalled immediately.

-(

22 The design should incorporate a requirement that failure of the securing mechanism would not prevent a full retraction of the source into its shielded position in the device.

s 30 It should avoid inadvertent operator errors.

60 A good idea if it would work properly.

86 Strongly approve,. but want to include the option of operating the unsecuring operation from a remote position.

OPPOSED Commenter 8

Thinks it will add to the complexity.of the devices, s

18 Will need added maintenance and it is unclear-that-it would be cost effective.

19 Retrofitting-will probably result in increased exposures.

Models that already have this feature have. failed, -- locking the source 4

outside the device rather than inside.

32 Do not think it will improve safety.

Tech-Ops model 900 which has this option can be defeated by taping the locking knob in the upright

position, o

33 Could be a problem maintenance wise.

Also personnel could by pass'it if it caused aggravation.

-i 35 Complicates exposure sequence,'--- it also could be bypassed.

16

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F OPPOSED (Cont'd)

Commenter 33 Opposed.

Costs too much to modify equipment and replacement costs are also high.

40 Feel that it is unnecessary.

Our procedures presently call for the j

radiographer to lock the projector and also the cranking device itself.

42 Extremely negative response.

Lack of maintenance or work in hostile condition could cause problems.

43 Will need maintenance and will not be cost effective.

Object.to having to manually reset device af ter each shot.

l l

47 Will lessen dependence on surveys.

49 Reduces radiographer's use of survey meter.

Also locking devices that secure the control cable greatly increase cable wear.

64 More parts can cause more malfunctions.

Also could keep source out i

of device.

1 81 Present equipment is adequate.

84 Would reduce the use of survey meters.

Also certain procedures on aircraft engines would be impossible with this feature.

l 88 Could cause source to be locked out.

I Staff Position The staff does not agree that this provision would cause a problem.

Many of the incidents involving sources slipping out of the shielded position is due to wear imposed by foot operation of manual locking mechanisms now on existing radiographic exposure devices.

The only change this provision will make would-i 17

be to require manual unlocking before the next exposure, something that should also be required if present procedures are followed.

The provision will remain as proposed.

$ 34.20(c)(4) REQUIRE SAFETY PLUGS OR COVERS A total of sixteen comments were received on this requirement.

All of them spproved.

There were only three substantive comments received, as follows:

Commenter 65 Approve of the requirement as long as the covers or plugs are not integrated as a working, moving, function of the device.

74 Urges that radiography devices be equipped with a receptacle of some sort to hold the covers or plugs and keep them clean.

Taping them to the camera as has M en practiced by some radiographers, results in a sticky residue wnich attracts grit which then works its way into the device when the covers are put in place and tends to cause internal wear of parts.

j 89 Equipment should be required to perform satisfactorily under adverse environmental conditions and it should be left to the manufacturer to determine how u achieve this.

StaffPos,igen i

General design conditions under Section 5.1 of ANSI N432 presently call for the expecure devices to be designed with due regard for the need to minimize the entry of water,. mud, sand, or other foreign matter into the controls or j

moving N rts.

The staff feels that the requirements as stated will require users to use 6ppropriate plugs or covers during storogs or transportation.

No change $s to be made in this requirewnt.

18

I C

6 34.20(c)(5)

LABELLING OF SOURCE OR SOURCE ASSEMBLY t

A total of twelve cf.wents were received cn this requirement.

One was opposed and elesen approved.

Only two substantive comments were received, as follows:

Commenter 64 The requirement does not pose a problem if it doesn't interfere with the lock or guide tube operation.

However a durable tag that is l

large enough to be visible without unrolling (leading to a large dose to the fingers) and that doesn't interfere with the operation of the source will be very hard to design.

Due to size, engraving will also

[

not be visible until serious overexposuu has resulted.

88 Do not think that this is a practical idea.

We should see if it can be done successfully before making it a regulation, i

Staff Response This requirement has been a' effective part of the-Texas radiation control regulations since October 1,195 /, and while there were a few problems ini-tially, these appear to have be in solved.

Initially heat shrinkable plastic was used but was found to wrinkle, gum up and even caused sources to hang up in the guide tube.

The next attempt was to use a soft metal sleeve containing the required information which was to be crimped tightly on the pigtail.

This was found to cause some hang ups in sharp S-tube devices.

Currently the method used by most manufacturers involves laser etching of the pigtail.

For Texas, the words Danger - Radioactive are etched on the source capsule itself'and the serial number of the source is etched on the connector end of the pigtail.

The requirement will remain as written in the proposed rule with the understanding that any successful method of labelling, including laser etching, will be acceptable.

19

I i

6 34.20(c)(6) GUIDE TUBE CRUSHING TESTS AND KINKING RESISTANCE TEST A total of ten comment letters were received on this requirement, eight appreving and two opposed.

The only substantive comments came from the aircraft maintenance community and these are listed below:

Commenter 23 The thin walled guide tubes used to inspect vane pins on aircraft engines would not meet the kinking and crushing tests proposed.

i 67 There are occasions when other types of guide tubes are required, such as braided tubes or stainless steel.

How does NRC suggest handling these issues from a regulatory viewpoint?

88 Some of our guide tubes used in power plant turbines will not pass this requirement.

Stoff Response The provision is left unchanged.

Crushing tests are specified in the standard and an acceptable kinking test is outlined in the Public Comment sec-I tion of the Final Rule.

Persons who have special requirements may apply for an exemption under S 34.51.

6 34.20(c)(7) REQUIREMENT TO USE GUIDE TUBES A total of three comments were received on this requirement.

All were approving.

One question was raised and this is listed below:

Commenter 18 What is the implication of conduits in this requirement?

20

Staff Response In the American National Standard N432 under definitions is found the following:

SOURCE GUIDE TUBE (CONDUIT)

In the International Standard ISO 3999 the same piece of hardware is referred to as:

PROJECTION SHEATH It is simply a matter of usage and the word has no particular significance except to provide some added clarity.

The word conduit has been rtmoved.

6 34.20(c)(8)

Rt' QUIRE THE USE OF EXPOSURE HEADS A total of eight comments were rt.ceived on this requirement.

All were favorable.

One commenter suggested comt,ining this with the next requirement.

Commenter 18 e

Why not designate all terminations designed to prevent emergence of l

the source from the guide tube as requiring a pull test when manufactured?

l Staff Response i

We think that this is what 9 34.20(c)(9) actually says.

No changes are to be made.

S 34.20(c)(9) REQUIRE A GUIDE TUBE TENSILE TEST Only two comments were received on this requirement, both were in favor.

Staff Response No changes are anticipated for this requirement.

1 21 I

a

'd' i

S 34.20(c)(10) SOURCE CHANGERS A total of three comments were received on this requirement.

The comments received were as follows:

Commenter 1

Raquirements for source changers should be separated out from this paragraph--- more appropriately as a 5 34.20(f).

8 Source changer design is adequate.

88 Most source changers leave something to be desired.

Staff Response Since source changers fall within the category of associated equipment, no need is seen for relocating this provision.

The words have been changed slightly to help make the intent of the provision more clear.

6 34.20(e) COMPLIANCE WITH SECTION 34.20 AFTER 5 YEARS Twenty-seven comments were received on this requirement.

Two, or 7 percent of the commenters approved and twenty-five, or 93 percent were opposed.

The principal comments were as follows:

APPROVED l'

Commenter l

l 76 Approves of the five year limitation here but requests two and one half years for compliance with 6 34.20(d).

9 h

22

n m nm-OPPOSED Commenter 2

This would be a financial burden on users.

Also lifetime depends on use, environment, and whether lazy 5 or sharp S tubes are used.

4 Feels that the government is trying to help industry sell more devices.

The five year limit should be extended to ten years.

13 Seasonal work extends the lifetime of devices as there is less use.

Use, work conditions, type of S tube etc. determine lifetime. Would preft;r to see a periodic inspection by manufacturers to determine

~

when to recall devices.

15 Five years is too short.

Cobalt 60 devices are used much less than-those with Iridium and should have a longer life.

Lifetime depends on type, use, and quality of the. maintenance program.

Replacement of devices with those corpiying with the rule should be determined by attrition.

IB Lifetime is determined by how far the source has to be cranked out as well as by type of S tube and amount of dirt in work area.

Could consider revalidating equipment as required for Type 8 packages under Part 71 with manufacturers assessing the safety and need for replacement.

22 Existing equipment should have a ten year time frame to comply.

26 Five years is too short.

Some devices have a life expectancy of ten to fifteen years.

Also replacement costs are high, ours would be

$48,000.

27 The five year grace period will cause a financial burden.

Experience has shown that properly maintained equipment will perform in excess of ten-twelve years.

23

OPPOSED (Cont'd)

Commenter 28 Maintenance record and lifetime of devices used by the Navy appear to be well beyond the five year lifetime estimated in the rule.

Also the replacement cost would be prohibitive, 5637,500.

This would not be a prudent use of funds, i

32 Many devices last longer than five years.

Propose that attrition determine the replacement of devices.

It is also expensive, our estimate of cost is $111,000, over the five years.

38 The five year service life is excessively conservative, ten to fifteen years ir, closer to the norm.

If enacted this could result in premature replacement of perfectly safe and useful equipment.

Our estimated cost for this replacement is $183,000.

If this rule is adopted we recommend two to five years for manufacturers to comply and seven to ten years for users.

64 Have reservations about setting a time limit for compliance with a standard especially when working models for some of the provisions i

have yet to be developed and tested.

7f Lifetime should be more like twelve years.

Six out of seven devices.

purchased in 1967 are still working fine at our company.

77 Five years is unacceptably short.

Equipment should be sent back to the manufacturer or an approved service center for appropriate maintenance every two to three years.

There is only one type 1R device available at present and that is 82 only for Iridium.

'here are no type 1R devices for Cobalt available, I

at least in the USA.

This firm is presently putting on hold any new

.j Cobalt 60 business as present devices cost $15,000, and would be ren-dered obsolete by the rule.

If the rule passes 11: its present form this i

firm will probably hive to discontinue business, 24

OPPOSED _(Cont'd)

J Commenter i

83 Experience has shown that properly maintained equipment can safely last ten to twenty years.

Our replacement costs would be $60,000.

Our cost of replacement would be $150,000.

l 85 Staff Response t

The staff is aware that retrofitting of existing radiographic exposure devices to meet the requirements of the rule is not practical, and that meeting the requirements of the rule will therefore involve the purchase of new equipment that meets all the requirements.

The staff is aware too, that the radiography industry is in a period of recession and that, as a result, many smaller radiography firms have gone out of, business.

A side-effect of this depressed state of the industry has been the creation of a large market'in used radiographic exposure devices.

The staff is concerned tiat many of the devices how in use by the industry may be from 10 to 20 years olt, no longer in production, and replacement parts unavailable.

Emphasis of thil point is shown by the intent of one of the larger device suppliers to issue a natice phasing'out of service over a period of 3 years beginning in 1989, certain of the devices it normally services because of j

unavailability of replacement parts.

The staff feels that many other devices I

with similar problems not subject to this notice are also. in use in the market place.

This provision will help to phase out of use such unserviceable and l

presumably, unsafe devices.

While many of the commenters feel that this pro-

~ t vision will pose a financial burden to users.and could result in premature replacement of safe and useful equipment, this view is not shared by the staff.

While conceding that the lifetime of many devices may be as much as 10 years, the staff feels that many of the devices currently in use need to be replaced with devices meetings the criteria of the rule.

With regard to the charge that l

compliance with the new rule would constitute a finant.ial burden, it should'be' pointed out that all equipment in use at the time of publication of the prposed rule will have been in service for a period of more than seven years at the-date required for compliance, and would therefore also have been eligible for a-25

seven year application of its depreciation allowance.

This allowance would seem to appreciably reduce the financial burden claimed by the commenters.

In addition, the regulatory analysis for this rule inilicates that the cost to the industry resulting from implementation of this provision of the rule is of the order of $4 million dollars on a 1989 present worth basis calculated over the ten year interval from 1990 to 1999.

The cost to tha individual licensee resulting from implementation of this provision of the rule over the same ten year period is $3636.

Annual costs over this ten year period are therefore

$400,000 for the industry and $364 for individual licensees.

In view of the i

arguments presented here the provision remains as proposed except that the five year period shall start from the effective date of the final rule.

l S 34.21 LIMIT ON EXTERNAL RADIATION LEVELS Only five comments were received on this requirement, three approved and two were opposed.

The three comments of significance are listed below:

APPROVED Commenter 18 We support the radiation levels of less than 200 mR/hr at the surface or 50 mR/hr at 5 cm. We also suggest a standard such as maximum surface area to be measured or maximum size of the radiation detector to be used.

For radiography exposure devices at 5 cm, large differences in measured dose rates are possible dependent upon the detector size.

OPPOSED Commenter 21 Requiring all radiographic equipment to meet the levels specified in ANSI N432 will initially cost licensees a great deal more than indi--

cated without corresponding radiation safety benefit.

The outside radiation levels on existing equipment has not been found to be a major contributor to radiation exposures to radiography personnel.

26

j 1

OPPOSED (Cont'd)

Commenter 86 We support the incorporation of ANSI

,.' except for the condition of reduced exterior radiation levels specified for the following i

reasons:

(1) There is no evidence of a radiological risk associated with current radiation levels.

Without indication of a health hazard, reducing limits based on safety concerns is not justified.

(2) The discussion of radiation levels indicated that surface levels could be as high as 800 mR/hr.

Our experience with devices man-ufactured over the past 15 years indicate maximum levels of approximately 350 mR/yr.

(3) It is not possible to meet the proposed external radiation levels with existing devices.

Unless there is compelling justification,

+he pursuit of ALARA and the necessity' for compatibility with DOT and ISO specifications will result in an extreme financial impact on the radiography industry.

Staff Response The issue of external radiation levels was discussed under comments to S 34.20(a) and'will not be repeated here.

The final version of this provision f

will now read five years after the effective date of the rule.

S 34.30 REPORTING REQUIREMENTS Sixteen comments were received on this requirement, six, or 38 percent approved and ten or 62 percent were opposed.

The only substantive comments were those received from persons opposed to the requirement and the principal comments were as follows:

27

s Commenter Don't agrie with this requirement.

Think that reporting of defective 8

equipment should be reported under 10 CFR Part 21.

22 Approve of the additional reporting requirements for the case of a disconnect or vi an overexpuncre.

Feel that the other itees are normal maintenance problems that occur on an average of ten times per year.

The cost of reporting these is underestimated.

We ftel that reporting ten of these normal maintenance problems per year would cost us $3300.

27 This reporting is unnecessary unless there is an overexposure.

Better enforcement of existing regulations would go a long way toward reducing violations and overexposures.

S 34.30(a)(3) is ambiguous and open ended, excessive and unnecessary.

38 The sheer volume of documents staggers the imagination.

Regulatory monitoring is adequately served by S 34.30(a)(1) and (2).

45 Riporting equipment failures is difficult and impossible to enforce.

Licenseeswilljustnotdoit.

l 59 Agree that significant malfunctions should be reported but that other component failures should merely be filed for NRC inspection and review.

64 Feel that S 34.30(a)(3) is too all encompassing.

Suggest that this be rewritten.

Also feel that an annual compilation of all these reported equipment failures be published annually by the NRC.

67 Should make this a data collection requirement only.

88 It won't work.

Some companies.can only afford cheap equipment that is prone to more problems.

They won't comply because they know that if they report honestly the equipment will be banned by the NRC.

28

1 Staff Response The staff agrees that item three of these provision was ambiguous and has rewritten it to apply only to components critical to safe operations.

l 6 34.33(a) REQUIRE WEARING OF AN ALARM DOSIMETER Fifty comments were received on this requirement.

Eighteen, or 36 percent of the commenters approved and thirty-two, or 64 percent were opposed.

The principal comments were as follows:

APPROVED Commenter 18 We recommend the use of a modern chirper.

Also we should specify an alarm rate meter instead of dosimeter.

23 The requirement has merit, we are considering purchasing some.

27 This is a good idea and is widely used in tha nuclear power industry.

However, calibration or daily checks may be a problem.

NRC requires a daily check but does not specify how it should be done -- NRC should specify the criteria for su:h checks.

30 Specify alarm rate meter instead of dosimeter.

Also modern chirpers should not be banned.

44 Believe in personal alarms for radiographers but should be able to use state of-the-art chirpers.

Trigger level of 500 mR/hr is much too high.

53 Concur especially in this requirement but specifies that'the alarm t

should also go off if the device is subject to radiation saturation.

60 Good precaution but don't like the 500 mR/hr level field test as this would result in unnecessary exposure to the radiographer.

+'

29 r-+-,

if I

J APPROVED (Cont'd)

J Commenter i

64 Concur in their use.

Don't like the 500 mR/hr alarm level.

Also should be aware that they can malfunction and read zero.

73 Feel'that this requirement would do more to protect radiographers than any equipment design change.

79 We have used audible alarms for ten years and they have cut our overexposures to zero.

OPPOSED Commenter I

2 Does not address problem.

If radiographer cannot adequately monitor his survey meter then two man crews should be required.

Don't need if proper surveys are made.

Recommends two man crews for 4

all field assignments.

7 Survey meters with audible alarms and belt clips are available.

If radiographer's hands are full he should have an assistant.

8 Use of alarm dosimeters should be optional, not mandatory.

10 Unnecessary when a survey meter is in uso.

13 Have mixed emotions --- in the past some employees used them and became too dependent on the alarms.

f 15 Reliance on alarm dosimeters could lead to overexposures.

22 Object.

Management and regulatory agencies need to enforce proper procedures instead.

OPPOSED (Cont'd)

Commenter 26 Will tend t9 reduce radiographer's use of the survey meters, 28 Will result in non performance of radiation surveys and may have a i

negative impact en safety.

This proposed solution fails to address L

the basic problem of management control and lack of aggressive enforcement.

33 Object because of start-up cost and maintenance.

Also feel that chirpers should be allowed.

34 Opposed, chirpers do not work in noisy environments, ---also think that a hearing test may be required of individuals wearing alarm dosimeters.

i 35 Is of negligible benefit---- just another piece of equipment that could lead to reduced use of survey meters.'

I 38 Recommend that this requirement be dropped.

Also maintenance and calibration could be costly, $7,800 initially and $2,600 annually.

40 Our strongest objections are to this requirement.

Feel that knowledge and experience of radiographers are the most important items.

Request an exemption from this requirement.for permanent facilities.

45 Alarm dosimeters are big, bulky and heavy and can get dropped or damaged.

A1.so radiographers may use them in place of a survey.

48 Object, use of surveys will deterioratm Money would be better spent on use of two man crews, each with a survey instrument.

49 Want to require survey meters with pre-set alarms instead of alarm dosimeters.

31

OPPOSED (Cont'd)

Commenter 59 Suggest an alarm on the survey meters in use.

i Will encourage radiographers to ignore the survey meter.

69 Alarm dosimeters will promote complacency in the use of survey l

71 meters.

81 Alarm dosimeters will add little to safety but greatly to users

+

expenses.

82 Feel that chirpers should be considered.

Opposed to trigger level of 500 mR/hr.

Wants to know why such high dose rates are allowed for alarm dosimeters when dosi rates from devices are limited to 50 mR/hr at five cm.

Radiographers will rely on alarm dosimeters *instead of the survey meter.

84 Staf' Response The staff does not agree with the assumption that radiographers will neglect using survey meters.

Also survey meters with alarms do not supply the redundancy of a separate alarm ratemeter since the alarm on the survey meter is connected to the survey meter output and it fails any time the survey meter fails.

Sound levels generated by alarm ratemeters are generally loud enough for most environments.

The provision has been changed to exempt permanent facilities from this requirement since other alarming or warning devices are already required.

$_34.33(f)(2) ALARM DOSIMETERS MUST ALARM AT A PRESET LEVEL OF 500 MR/HR i

Thirteen comments a <re reseived on this requirement.

All thirteen, or 100 percent were opposec No commenters approved.

Principal comments were as follows:

i l

32

l l

Commenter 1

This may require a check source large enough to require a specific license and could add considerably to the cost impact of the rule.

18 Believe that this level is too high because it is too difficult to test conveniently.

30 Should specify'an alarm rate meter instead of dosimeter.

Believe that the level is too high to test conveniently.

39 e

The licensee should be given adequate latitude to determine its own alarm level.

40 We don't want to use them at a permanent facility where there are already adequate alarm systems.

44 It should not take a 500 mR/hr field to cause an alarm.

47 The specified alarm level of 500 mR/hr is t'oo high.

53 Feel that the recommended 500 mR/hr level is too high a rate to trigger an alarm for Air Force needs.

56 The 500 mR/hr set point would be inadequatt around power facilities.

Suggest allowing the alarm setting to be a; 100-200 mR/hr above background.

60 Question the need for a daily response t st in a 500 mR/hr field.

64 Do not agree that the alarm trigger be confined to 500 mR/hr dose rate.

We presently use a beeper that beeps according to dose rates and also alarms at an accumulated dose that is pre-set by the user.

82 Commenter does not want his workers working in a 500 mR/hr environment.

33

~

l Commenter Alarm dosimeters are a good idea but the 500 mR/hr dose rate is too I

88 high.

STAFF POSITION i

Calculations for a 200 Ci Iridium source at a normal operator position l

(21 foot guide tube and 25 foot control tube) show that the radiation level is approximately 430 mR/hr.

Trigger. levels of much less than 500 mR/hr would I

cause the alarm to trip during normal operations and thereby defeat the purpose of the alarm.

Licensees that have a problem with this provision may apply for an exemption under S 34.51.

The requirement for checking the alarm level at 500 mR/hr on a daily basis remains unchanged.

This can be achieved by an elec-tronic check point.

Calibration requirements have been changed to require them on an annual basis instead.

Ns other changes have been made.

ASNT SURVEY The ASNT Survey which was discussed briefly on phge 7 consisted of 13 multiple choice questions.

A sample of the survey questions is given below along with the fraction of respondents responses to each of the questions.

The survey does not track the proposed rule and it is difficult to assess.

On thr, surface it appears that the respondents have a favorable outlook on all aspects of the proposed rule but this conclusion is at odds with the results ci peopla i

who provided direct comments on the rule.

r 4

0 34 e

The Americar Society for Nondestructive Testing, Inc.

Member Survey Regarding:

Proposed Safety Re quirements for Industrial Radiographic Equipment INSTRUCTIONS Before answering the survey questions, read all the material contained in this packet regarding the proposed rules.

Below, in statement format, are the 11 proposed rules which most _directly affect industrial radiographic equipment users.

For each proposed rule, you are given the choice of agreeing (being in favor of that proposed rule), disagreeing (being opposed to that proposed rule) or offer-ing no opinion.

Two demographic questions are also included.

Check only one answer per question.

Specific comments or questions about the proposed rules should be sent directly to the appropriate NRC address indicated in the enclosed Comments to ASNT may be provided on additional sheet (s) of paper and memo.

returned with the survey.

Please return this survey, NO L,TER THAN THURSDAY, JULY 28 to:

ASNT Attn:

Tim Strawn 4153 Arlingate Plaza Caller #28518 Columbus, OH 43228-0518 Thanks for your interest and co-operation in this effort.

QUESTIONS Total Respondents 399 8

1.

Are you currently or have you previously been a user of industrial radiography equipment?

0.995 Yes 0.005 No 35

Memo to Members.

2.

Are you sending comments on these proposed rules directly to the NRC in addition to returning this survey to ASNT headquarters?

0.21 Yes 0.79 No 3.

Radiography equipment shall incorporate the provisions of ANSI N432

" Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography" (reference:

National Bureau of Standards Handbook 136).

0.67 Agree 0.18 Disagree 0.15 No Opinion 4.

The coupling of the source assembly to the drive cable shall consist of application of motion in two planes and a positive force in at least one of the planes.

The coupling must be designed so that it cannot be

~

unintentionally disconnected.

0.90 Agree 0.05 Disagrea 0.04 No Opinion 5.

The exposure device shall be equipped with a visual indicator that irdicates when the source assembly is in the fully shielded position and the shutter (if any) is closed.

l 0.60 Agree 0.35 Disagree 0.05 No Opinion 6.

An exposure head or similar device, designed to prevent the source assembly from passing out the end of the guide tube, shall be attached to the outermost end of the guide tube.

0.86 Agree 0.11 Disagree 0.04 No Opinion' i

36

{

- - - - - - - ~ ~ - - ^ ~ ~ ~ ~

o Memo to Members '

7.

Both ends of the exposure device and the drive cable fittings shall be equipped with safety plugs or covers to prevent damage to the source assembly and prevent the entrance of foreign matter.

i i

0.92 Agree 0.05 Disagree 0.03 No Opinion 8.

The exposure device shall be constructed to ensure that when the source assembly is cranked back into the fully shielded position in the device, it shall be automatically secured in this position.

It shall only be possible to release this securing system by means of a deliberate operation on the exposure device.

~

0.75 Agree 0.21 Disagree 0.04 No Opinion 9.

Exterior radiation levels from exposure devices shall be reNeed to the

[

levels specified in ANSI N432.

For portable devices the limits are 200 mR/Hr @ surf ace or 50 mR/hr @ 50mm and 2 mR/hr IB 1.neter.

For mobile devices the limits are 200 mR/Hr @ surface of 100 mR/Hr 0 50 mm and 5 mR/hr @ 1 meter.

0.71 Agree 0.19 Disagree 0.10 No Opinion

10..If the licensee receives a device later than one year.after the effective date of the final rule, the device would have to meet all.of the require-ments of the rule at the time it is received and continue to meet them.

0.78 Agree 0.17 Disagree 0.05 No Opinion' 11.

All radiographic exposure devices'not in compliance shall be withirawn from use after five years from the date of publication of the final rule unless they are retrofitted to comply.

0.68 Agree 0.26 Disagree 0.06 No Opinion 37

o Memo to Members,

12.

Each radiographer and assistant shall wear an alarm dosimeter.

0.61 Agree 0.35 Disagree 0.03 No Opinion 13.

Radiography licensees shall report unintentional source disconnects, failures to retract and secure a source, and the failure of any device component to operate as intended.

0.63 Agree 0.31 Disagree 0.06 No Opinion i

30 i

A C /A - t.

l Md REGULATORY ANALYSIS FOR AMENDMENTS TO 10 CFR PART 34 ON SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC EQUIPMENT 1.

Statement of the Problem I

A total of approximately 1,100 firms currently possess radiography licenses to perform industrial radiography (e,ither at fixed iocations or at multiple locations) using gamma rays for the.ondestructive testing of pipeline weld f

joints, steel structures, boilers, aircraft parts and other related items and structures. Approximately one-third of these licenses have been issued by the Nuclear Regulatory Commission and the remaining two-thirds by Agreement States.

The firms employ an estimated 5,000 radiographers and radiographer assistants on a fu. ;- or part-time basis, but it is estimated that another 5,000 radio-i graphy supervisors are also actively engaged in the field for a few weeks each year.

An estimated 3,500 radiographic exposure devices (currently manufactured l

by 3 major companies) are in use, producing tens-of-millions of radiographic pictures per year and utilizing in excess of $20 million worth of radiographic film per y(ar.

l In general the industry may be characterized as consisting of firms that conduct their radiography at a' single location (36%) and those that conduct I

their radiography at multiple locations (64%).

Approximately 90% are consid-l ered to be "small entities" under the criterion established in Section 605(b)

{

of the Regulatory Flexibility Act of 1980.

Those operators with the fewest I

radiographers and devices generally perform nondestructive testing by a variety of methods,.only pe of which is radiography; and the operators are trained in other methods of nondestructive testing as well.

Radiation exposures received by radiographers have been a concern of the l

NRC anct Agreement States for some time.

During the years 1979 through 1983, radiograoher overexposures averaged 18% of all.overexposures although 1

ENCLOSURE B

radiographers r;present only 4% of all radiation workers.

These overexposures are usually a result of improper procedures or equipment problems, but the numbers due to each are not well known.

NRC exposure data indicate that equipment problems contribute to approxi-mately 40% of all reported overexposure events. Texas data indicate a much lower incidence of equipment problems (2 %), but exhibit such a high incidence of " unknown" reasons for overexposure (65%) compared to (15%) for NRC data that it is probable that additional equipment problems were contributors to some of these " unknowns."

In 1978 the NRC published an Advance Noti

• of Proposed Rulemaking (ANPRM, 43 FR 12718) to announce that it was undertaking the development of design requirements for radiographic exposure devices licensed under 10 CFR Part 34 as a means of reducing the number of large radiation exposures to personnel caused by equipment failure.

Among the many comments received concerning this ANPRM was the suggestion that the NRC delay further action pending completion of a consensus performance standard for such radiographic exposure devices.

In January 1981, a consensus standard, NBS Handbook 136, American National Stan-dard N432, " Radiological Safety for the Design and. Construction of Apparatus for Gamma Radiography" was published.

In March 1980, (partly as a result of a serious radiation accident involving a radiographic device that occurred in California in 1979), an ad hoc Radiography Steering Committee was formed, composed of both Federal and State government representatives, to draf t recommendations for improvino adiography safety.

The l

Steering Committee subsequently established four task forces tc address various aspects f the problem:

Radiographic Equipment Design Safety; 1 raining and Certification of Radiographers; Inspection; and Collection and Analysis of

ncident Data.

The proposed amendments discussed in this regulatory analysis are the product of the first task force listed.

They would affect two classes of licensees--radiographic equipment manufacturers and industrial radiography companies.

The proposed amendments are needed at this time as a means of reducing radiography exposures to both radiographers and to the general public.

Although 2

ENCLOSURE B l

l 1

tha consensus standard mentioned above was published in 1931, in the very con-petitive radiography industry, it is not clear that all manufacturers are using the consensus standard, the adoption of which is voluntary until required by regulation.

As a result, it is assumed that it has not had its full potential effect on reducing either the rate or the magnitude of radiography overexpo-sures.

Failure to take appropriate action at-this time would only allow the present rate of radiography overexposure $ to continue and possibly increase, and could lead to possible tragic incidents involving members of the public as well as workers.

2.

Obiectives These amendments are intended to achieve reductions k exposures to radiagraphers and assure that the public health and safety is protected in applications of industrial radiography that utilize sealed radioactive sources, through the imposition of safety performance standards in those areas where the task force has identified problems and suggested solutions.

Incorporation of performance standards in the regulations has the advantage of requiring indus-r trial firms to meet the performance standards rather than relying on voluntary compliance.

3.

Alternatives Three alternatives were considered:

(1) Take no action at this time (2) Propose new regulatory requirements calling for generally specified safety performance standards and a requirement for radiographers to wear alarm dosimeters; simultaneously. issuing a regulatory guide that endorses the standard N432 supplemented by additional perfor-mance standards and acceptable methods for meeting the altrm dosim-(.try requirement.

(3) Incorporate the described requirements in the regulations.

This involves incorporation by reference of the consensus standard N432 3

ENCLOSURE B i

in the regulations, and the incorporation of such other performance l

e standards as were recommended by the equipment task force, plus a requirement for radiographers to wear alarm ratemeters.

4.

Consequences Alternative (1):

Take no action at this time This alternative would probably lead to no change in the status quo.

The number of radiographer overexposures would probably remain e aut the same, and the probability of serious incidents involving members of the public as well as workers would also be unchanged.

This alternative '" aves the implementation of the consensus standard, NBS Handbook 136, up t. the manufacturers of the radiographic exposure devices.

This alternative would entail no additional costs to the NRC and only those costs to industry and licensees that were voluntarily accepted in implementing the consensus standard.

Alternative (2):

Propose new regulatory requirements calling for generally specified safety p.erformance standards and i

a requirement for radiographers to wear alarm rate-I meters simultaneously issuing a regulato:'y guide that endorses the standard N432 supplemented by. additional performance standards and acceptable methods for meeting the alarm ratemeter requirement.

Regulatory guides are issued to provide methods acceptable to the NRC for implementing specific parts of the NRC regulations.

They are not sub-stitutes for regulations and compliance with a guide is not required unless it is incorporated into a license.

In this alternative, the per-formance standards are specified in a general manner so that, although the methods outlined in the regulatory guide are acceptable to the NRC as a means of meeting the regulatory requirements, there is no requirement for licensees to adopt them.

The cost to the NRC for this alternative involves the cost of formally issuing new regulations associated with alarm ratemeters plus the cost of developing and issuing a regulatory guide.

4 ENCLOSURE B

..y..

l-The NRC estimates a staff effort on the order of 12 person-months at a O

cost of $7000 per person-month for a total NRC implementation cost of approximately $84,000.

The cost to the radiography industry is found in Appendix A to this regulatory analysis and is estimated to be a one time cost of $1,625,000 to provide alarm ratemeters to 5,000 radiographers and radiographer assistants and an annual cost of $863,000 for replacement of alarm ratemeters and batteries, calibration of alarm ratemeters, reporting and labelling.

To each of the estimated 1,300 radiography licensees these costs represent a one time cost of $1,477, and annual costs of $784.

On a 1989 present worth basis, total industry costs ara approximately $14.2 million.

No costs associated with improvements to radiographic exposure devices are assigned to this alternative as such improvements are not being proposed as new NRC regulations.

Although surveys indicate that approximately 90% of all radiography licensees qualify as "small entities," the costs cited here are not considered to constitute an undue burden on the industry.

No legal or other barriers to the adoption of this alternative have been identified.

Alternative (3):

Incorporate the described requirements in the regula-tions.

This involves incorporation by reference of l

the consensus standard N432 in the regulations, and the incorporation of such other performance standards as were reco3 mended by the equipment task force, plus a requirement for radiographers to wear alarm ratemeterst in this alternative the specific safety requirements are-included as part of the regulations through the incorporation by reference of the consensus standard N432.

Licensees would be required to incorporate the specific

. safety requirements in their exposure devices.

The cost to the NRC is i

projected to be somewhat less than that identified in Alternetive 2 because there will be no need to prepare a regulatory guide.

Assuming an NRC staff effort of 2 person months (at $7,000 per person month) for the promulgation of new regulations, the NRC implementation cost is approximately $14,000.

5 ENCLOSURE B a

The cost to industry includes all of the costs ~ identified under Alternative 2 plus the cost associated with the purchase and replacement of radiographic expusure devices.

These latter costs are estimated at 54 s

million on a 1989 present worth basis plus an annual recurring cost commencing in the year 2000 of $444,000.

On a per licensee basis these costs are estimated at $3636 and $404 respectively.

The bases of these cost estimates are presented in Appendix A.

Coupled with the costs discussed under Alternative 2, this produces industry-wide costs on a j

1989 present worth basis of approximately $21.4 million.

A :ctresponding-l value for individual licensees is on the order of $19,500.

No legal or other barriers to the adoption of this alternative have been idt ;1fied.

5.

Decision Rationale The staff proposes that. Alternative 3 be adopted.

Alternative l is not selected because the objective of this action is to improve public health and safety through the reduction of exposures to radiographers and to the general pub'lic by the application of safety performance standards for radiographic exposure devices and the required wearing of alarm ratemeters.

Alternative 1 appears to offer no hope of accomplishing this objective.

Alternative 2 also fails to address the objective because licensees.have the option of adopting the performance standards of N432 as they see fit.

Alternative 3 appears to accomplishthedesiredobjective.

While the costs of the proposed amendment have been discussed above and are amplified in Appendix A; the benefits heve not.

The benefits to be derived from a reduction in potential overexposures by the adoption of these amendments in the regulations _is difficult to evaluate on a monetery basis.

In general, it is not Deaningful to specify an average dose received as a result of a radiography overexposure because the dose could vary from a few rems to a dose sufficient to produce radiation sickness, injury, and even death.

6 ENCLOSURE B l

j Also, in many of the reported incidents the cause of the overexposure is 3

i either unknown or not reported.

A more appropriate approach to benefits is to consider the potential: benefits that might have accrued in specific incidents such as the 1980 overexposure in Texas that resulted in an individual dose of t

200 rems and a potential for'a much larger dose that was averted b,v luck; or l-the incident ~in Morocco in 1984 that resulted in the deaths of 8 persons.

6.

Implementation The NRC expects that the various requirementi of the rule will be made effective one~to five years after the effective date of the final rule.

All newly manufactured devices acquired by licensees after one year from the effective date of the rule must comply with the requirenents;

~

of the rule.

All devices in use prior to this' date must' comply with the ra f rements of the rule after five years from the effective date of the

^

rule.

This implementation schedule was chosen to give manufacturers tiw to incorporate the new provisions of the rule ~in the new devices and to-

~

~

allow users time to e' valuate the new devices.

Also it is doubtful that manufacturers would be able to provide 3500 new devices meeting the require-ments on a more accelerated schedule and further; the accelerated. schedule could imoose a severe financial burden _on licensees.

Regional inspectors

.will begin ' inspecting against the provisions of _the new' regulation one

. year after.the effective date of the final rule.

l.

This action will affect sections of 10 CFR Part 34 of the Commission's regulations.

No effects on other existing or_ proposed requirements have been identified.

i 7

ENCLOSURE B

l 1

APPENDIX A COST ANALYSIS s

i 1)

Replacement of Radiography Exposure Devices I

i ll The costs of incorporating the safety performance criteria for radiographic equipment were developed in 1984 by the Task Force on 2

Equipment Safety Performance Criteria ; a group composed of both NRC and Agreement State representatives.

The cost estimates developed relied upon discussions with major equipment manufacturers as well as the informed judgment of the Task Force members, i

i Independent of the proposed rule, the staff assumes that there is a continuous i

need to periodically _ replace 3500 radiographic, exposure-devices as they wear-out.

Based on an assumed operating life of ten years per devices it is estimated that on average 10% or 350 devices will be replaced annually..

Therefore, a major incremental cost resulting from' this proposed requirement 1

is the cost of the additional safety features incurred during these annually replacements.

This is estimated at $1268 per device, the basis.of which is i

detailed in Table 1. 'The average annual cost to industry is ettimated at-

$444,000 ((350 devices) x $1268)).

On a per-licensee basis the average i

annual cost is $404.

For reasons explained below, it is assumad these costs--

I commence in the year 2000.

The' staff also recognizes that when this reauirement becomes effective in 1995 there will.be a need for industry to accelerate its replacement of-expo ure devices.

This is because even devices that are serviceable and have useful j

remaining lives will have to be discarded in 199h if they do not contain-the enhanced safety features prescribed in the rule.

To estimate this cost the, 2" Radiographic Equipment. Safety Performance Criteria," Task Force on Equipment

^

Safety Performance Criteria, April 30,1]84.

2The staff recognizes that the usefu' life per device can very dramatically 4

depending on such_ factors as its usage rate, variations in model designs, and site specific conditions.

However, based on discussions with manufacturers

-and licensees, 10 years appears to be a reasonable estimate.

If these devices prove to be more durable, the corresponding annual costs would be less than those reported here.

Alternatively, shorter useful lives will result in higher annual costs.

8 ENCLOSURE B a

8 staff looked at a ten year period encompassing the 1990 to 1999 time frame.

Without the rule, it is expected that industry would continue to replace 10%

of its exposure devices per year at a cost of $5000 per device.

On a 1989 present worth basis (5% real discount rate) the costs incurred between 1990 j

. and 1999 are estimated at $12.867 million.

With the rule in place, it is assumed that during the 1990-94 time frame the industry would continue to replace worn out devices at a rate of 350 per year, but in anticipation of the i

rule would purchase devices with enhanced safety features at a cost of $6268 per device, in addition, in 1995 when all exposure devices must meet the new safety standards, the remaining 1750 devices would be replaced at a unit cost of $6268. On a 1989 present worth basis this cost stream equals $16.844 million.

The cost differential between these two expenditure streams, expressed on a 1989 present worth basis, is about $4 million and can be viewed as the incremental cost of replacing the current generation of exposure devices, some of which'would still have a serviceable useful life.

2)

Purchase of Alarm Ratemeters Assuming the purchase of one ratemeter for each of the estimated 5000 working radiographers and radiographer assistants at an estimated cost of

$325 each, the total cost to the industry would be $1,625,000.

For each of.the estimated 1100 licensees the cose. would be 51477 3)

Annual Cost for Alarm Ratemeter Replacement if the estimated average lifetime of the alarm ratemeter is taken.to be_ _

five years, then the 5000 ratemeters will have to be replaced at the rate of 1000 per year.

The annual cost to the inaustry will'then be $325,000 and to each of the 1100 licensees $295.

4)

Annual Cost for Alarm Ratemeter Calibration The average cost of calibration of alarm ratemeters is estimated to be

$50 each, based on information from persons who provide such services.

' 3Since this analysis takes into account the incremental costs incurred through 1999, the preceding analysis begins capturing annual costs commencing in the year 2000.

9 ENCLOSURE B d

c.

Since the rule requires an annual. calibration, the annual cost of j

calibrating 5000 ratemeters would be $250,000 to the industry and $227 for each licensee.

j 5)

/inuai Alarm Ratemeter Battery Replacement Battery life for alarm ratemeters depends on the count rate, but-the average lifetime appears to tie around 200 operating hours or approximately one working month.

Most use nine. volt transistor batteries that cost approximately $3 each.

The costs per ratemeter would therefore be about

$36 per year.

Cost-to the industry would be $180,000 and to each of the i

1100 licensees $164.

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6)

Annual Reporting Requirements Based on records of past incidents involving radiographic exposure dcVices, it is estimated that the new reporting requirements specified in 634.30

[

could result rn an additional 50 reports annually.

Using an estimate of l

one hour per report and a cost of $60 per hour the annual-cost to the industry would be $3000 or approximately $2.75 for each licensee, i

7)

Annual Labelling Requirements

)

i The new requirements for labelling specified in S34.20(b)(1) are estimated to require about 1.5 labels per year for Iridium devices. This amounts to-5250 labels per year for the estimated 3500 devices currently in use.

The estimated time per label is one third of an hour (20 min) and the costs are estimated to be $20 per label (based on $60 per hour).

Annual cost to the industry would then be $105,000 and the cost to each licensee would be

$95.

-i 10 ENCLOSURE B

4 Table 1.

Costs for Incorporating Performance Criteria (Adapted from Task Force Report)

No. of Replacement No. of Annual Cost Performance Cost Range Exposure Frequency Units Range Criteria

• Per Unit ($)

Devices Per Year Per Year

($/Yr)-

a.

Source' Pigtail label

.5 3500 2.5 8750 4,000 b.

Connector 35 3500 2.5 8750 310,000 c.

Lock operable only with 100-200 3500 0.1 350 35,000-70,000 source shielded d.

Control removable ~only 50-100 3500 0.1 350 17,500-35,000 with source secured in the' shielded position e.

Control operation 50-100 3500 0.1 350 17,500-3500 possible only with source connected f.

Automatic source 50-100

- 3500 0.1 350 17,500-35,000-

-assembly trap _

mechanism Total (if lock box criteria implemented separately) 401,500-499,000 Point Estimate 444,000

• The following performance criteria are already in use, thus, minirsum cost is involved:

1.

Pull test of pigtail assembly and drive cable assembly.

2.

Guide tube performance crit &ia.

3.

Safety plugs for outlet nipple, lock box, and drive cable fittings.

4.

Source assembly cannot be moved through the back of the device.

5.

Controls to be marked to indicate the direction of cable movement.-

l l

.w..

. Table 2 i

Summary of Costs 1

Alternative 2 Alternative 3 1

Industry Licensee Industry Licensee 1(a) Purchase of radiography

$ $ $4,000,000

$ 3636 devices

• l 1(b) Annual replacement of 444,000 404.

radiography devices **

- 2(a) Purchase of alarm ratemeters***

1,625,000 1,477_ 1,625,000 1,477 2(b) Annual ratemet replacement ***

325,000 295 325,000 295.

3)

Annual ratemetr calibration **'

,000 227-250,000 227 4)

Annual ratemeter battery replacement ****

180,000 164 180,000 164-

~

f 5)

Annual Reporting requirements ****

3,000 3

3,000 3

6)

Annuallabelling requirements ***

105,000 95 105,000 95 i

1989 Present Worth Total Cost *****

$14.2 Million

,$12,900 $21.4 Million

$19,450

• This cost-is already expressed on a 1989 present vorth basis.

• • Annual cost assumed to commence in year 2000 and continue for 20 years.

l

• • • 0ne time up front cost incurred in 1990... _

~

J L

• • • • Annual costs assumed to commence in year 1990 and continue for 30 years.

(

• • • • • 1989 present worth based on a 5% real discount rate..... captures costs between 1990 and 2020.

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u 12 ENCLOSURE B~

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14 e a :n gg W

ENVIRONMENTAL ASSESSMENT AND FINDING OF NO SIGNIFICANT IMPACT REVISION OF 10 CFR PART 34 SAFETY REQUIREMENTS FOR INDUSTRIAL-RADIOGRAPHIC EQUIPMENT.

The Nuclear Regulatory Commission is amending its regulations that apply _

j to industrial radiography to require additional safety features for industrialc radiographic equipment and~ require that radiographers wear alarm ratemeters.

{

l Environmental Assessment m

Identification of Final Action 10 CFR Part 34 specifies'the radiation safety requirements for' radiographic.

operations, including performance requir_ements.for industrial radiographic devices, personal radiation safety requirements for radiographers and precau-tionary procedures in radiographic operations.

This revision will specify additional performance requirements for; industrial radiographic equip-ment (Sections 34.20), a requirement for reporting equipment malfunctions (Section 34.30), and additional personnel radiation monitoring requirements for 9

radiographers (Section 34.33).

Need for the Final Action The number of radiation overexposures and potential overexposures of both' radiographers and the general public'has been'a cause of concern to the NRC for a number of years, primarily because the_ radiation levels of the radioactive j

sources used in industrial radiography are sufficient to cause serious _ injury j

or death.

Although a voluntary consensus standard that incorporates many of f

the proposed performance requirements-has.been available since 1981, there is.

4 1

4 little evidence that all manufacturers have adopted the standard completely in the manufacture of their equipment.

In addition, a recent NRC analysis indicates that some 40% of all radiography incidents involve equipment problems.

In view of these facts, it is felt thati

[

regulatory action is needed at this time.

l Environmental Impacts of the Final Action.-

The revision of 10 CFR Part 34 should have no W ironmentally significant t

impact.

The final performance requirements will in9olve engineering design =

modifications and will require radiographers-to wear alarm ratemeters, but requirements for energy, water, and materials will be insignificant and no environmental or radiation impact will be involved.

Alternatives to the Final Action As required by Section 102(2)(E) of NEPA (42 USC 4322(2)(E)), possible alternatives to the final action have been considered.

The first alternative considered was to take no action at this time.

This-alternative is not acceptable since the number of overexposures.of radiographers and the general' public would continue unabated.

j A second alternative considered was to incorporate the additional performance-requirement into a regulatory guide. -However,-since regulatory guides are not substitutes for regulations, compliance with a regulatory guide is not required except in those cases where compliance is specified as a licensing condition.

This alternative in effect renders compliance voluntary and makes it unacceptable.

Amendment of the existing regulations was chosen as the best alternative.

Alternative Use of Resources No alternative use of resources was considered.

2

Agencies and Persons Consulted Consultations on the. rule have been held with Agreement State representatives from California, Louisiana and Texas.

Also, discussions t

regarding the content and purpose of the rule were held with representatives I

of radiographic device manufacturers and with representatives of nondestructive testing companies involved in radiography, i

t Finding of No Significant Impact

l The Commission has determined not to prepare an environmental impact statement for the-final rule.-

i i

Based on the foregoing environmental assessment we^:oncluded that this amendment will not have a significant effect on the quaisty of the environment,

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3 4;

-l Document Nime:

10 CFR 34 i:NVIR ASSE ENCL C i

Requestor's ID:

COATES i

Author's Name:

NELLIS, D Document Connents:

. WFN EOS 2/17/89 KEEP SHEET WITH DOCUMENT 4

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