ML20246B501

Recommends That Commission Approve Notice of Final Rulemaking Re Amends to 10CFR34, Safety Requirements for Industrial Radiographic Equipment

ML20246B501
Person / Time
Issue date:	06/28/1989
From:	Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
TASK-RIA, TASK-SE SECY-89-194, NUDOCS 8907070357
Download: ML20246B501 (116)

Text

{{#Wiki_filter:,. -. -.. - a -O;_ in ; g _ - w:.,.,. I ~ b. Ul [ I... il >[. a 4. <+ 2 1 2 a nscu 8 \\..... y,i June 28, 1989 SECY-89-194 (Aff.irmat. ion) .For: The Commissioners From: Victor Stello Jr. Executive Director for Operations

Subject:

AMENDMENTS TO 10 CFR PART 34: SAFELY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC EQUIPMENT ~

Purpose:

To obtain Comission approval of a notice of final rulemaking. Issue: Improvement in safety requirements in industrial radiography operations aimed at reducing exposures to radiography personnel and potential exposures to members of the general public. Sumary: This paper recommends amending 10 CFR Part 34 to specify additional safety performance requirements for industrial radiographic equipment, to add additional reporting requirements, and to require that radiographer wear alarm rate meters. Discussion: Industrial radiography, a technique of nondestructive testing, uses radioactive sources or x-rays to detect flaws in welds and cracks, breaks, etc., in bridges, buildings, and manufactured articles. Most radiographic devices use gama rays to produce radiographs, although x-rays and neutrons are also used. Approx-imately 90% of these devices are designed to project a radio-active source out of its shielded position within the device to the working position. The procedure for taking radiographs is to place a film about the object to be examined, position one end of a guide tube (the Other end is attached to the radiographic device) on the other side of the object from the film, crank or project the radioactive source from its shielded position in the device to the end of the guide tube, leave it there for the required length of time, crank the source back into the device, and recover the film for processing.

Contact:

D. O. Nellis, RES 492-3628 / 90 10 m i. p y a t, p_. Y 9. :,, / i

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1The Commissioners 2 Although the procedure appears straightforward, radiation over-exposures of radiographer and the general public occur with a frequency that concerns both the NRC and the Agreement States. Additionally, serious injuries and even some deaths (all outside the United States) have occurred as a result of cccidental over-exposures involving radiography operations. The potential for serious consequences is present because of the high intensity of the radioactive sources used in industrial radiography. Large overexposure have' occurred mainly among radiography per-sonnel, but the most severe consequences have occurred to members of the public. In one case for example, an individual in California picked up a source and put it in his hip pocket and suffered a severe radiation burn. A similar case occurred in India, and in' Argentina, a man put a source in his pocket and had to have both legs amputated. In another case, an individual picked up a source and took it home where it caused 8 deaths; a similar case occurred earlier, resulting in 4 deaths. In all cases, a radiation survey could have prevented these exposures by indicating the source was not in the radiographic exposure device. Improved equipment may also have prevented some of these accidents. Over the decade ending in 1984, entities licensed by the NRC to perform industrial radiography have accounted for more than one half of the reported radiation overexposure greater than 5 rems whole body or 75 rems to extremities. The Agreement States have had_similar experience. Most of the reported-radiography overexposure have involved unsuspected unshielded sources and failure to conduct proper radiation surveys at the end of every radiographic exposure. As discussed below, a variety of problems have resulted in unsus-pected, unshielded sources. Insufficient experience, inadequate training, work pressures, and the routine, repetitive nature of the work have contributed to Oe failure to conduct surveys. NRC data indicate that equipment problems are the initiating event in approximately 40% of all reported overexposure events. The radiographic exposure devices incorporate components such as locks and source guide tubes that are important to radiation safety. On occasion, a component has failed to perform its intended function and that failure, together with the radiographer's failure to follow proper radiological safety prac-tices, has caused unnecessary exposures to the radiographer and others in the immediate vicinity. The type of situations which have been determined to contribute to radiography overexposure are:

L% 'X m y gThe Commissioners: 3 t-L (1) The radioactive source moves out of its shielded position l after being cranked back into the device due to failure of. l the securing device (or some other reason). '(2) The' source is improperly connccted or not connected to the control cable so that it will not retract once it has been projected out of the device. '(3) The source is cranked out of the end of the guide tube.and L falls to the ground because of connector failure or improper.. connection. (4)' The source becomes stuck in the guide tube due to damage to the guide tube or due to fraying of the control cable. In an attempt to reduce serious radiography overexposure which may be the result of equipment problems, the NRC published an Advance Notice of Proposed Rulemaking (ANPRM) on March 27, 1978, (43 FR 12718) that proposed the development of safety requirements for radiographic devices that are licensed under 10 CFR Part 34. Comments on the ANPRM requested thet the NRC delay further action until completion of a consensus performance standard in this area. In 19S1, a voluntary consensus standard, NBS Handbook 136, American National Standard N432 " Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," was issued. In 1980 an ad hoc Radiography Steering Committee composed of NRC personnel and representatives from California, Louisiana, and Texas, (states that have large numbers of radiography licensees) was formed to draft recommendations for improving radiography safety. Of four task forces established by the Committee, the one on Radiographic Equipment Safety Design was charged with developing recommendations on performance criteria for radiographic devices. In 1984, the Task Force issued its recommendations on performance requirements. These included most of the performance criteria specified in the consensus standard plus additional criteria not found in the standard. One addi-tional item that was sug ested during meetings of the Steering Committee was that radiographer be required to wear alarm ratemeters as an additional safety measure in the event the survey meter is defective or is not used as required. On March 15, 1988, the NRC published for public comment a proposed rule (53 FR 8460) that would require radiographic exposure devices and associated equipment to meet the requirements specified in American National Standard N432 plus a number of additional criteria that were recommended by the Radiographic Equipment Safety Design Task Force described in the previous paragraph. Sixty-eight comment letters were received with the average commenter addressing comments to approximately 10 of the 26 items involved in the rule. Of the 26 items proposed, comments were equelly divided on two, opposed f

K 3: ;W 3 r* . The'Commissior.ers 4 on nine and in' favor on 15. The principal opposition was. directed' to five items; source position indicator, automatic securing of the source, the five-year replacement requirement, need for alarm ratemeters and the proposed trigger levels for alarm ratemeters. . A general analysis and resolution. of.the coments is given in the Supplementary Information section.of the Federal Register Notice (Enclosure A) and additiona~1:information is included in the. L Analysis of Comments ~ document (Enclosure D). The enclosed final rule, which adopts most of the Steering Committee recommendations, is intended to provide additional safety performance requirements for radiographic equipment and-recommends, in addition, that a redundant safety device be worn l, by radiographer as a means of reducing radiography overexposure to both the general public and to radiographer. Both NRC and the' Agreement States regulate equipment manufacturers l and radiography licensees in their respective areas. Because the l manufacturers distribute nationwide and because a radiography company may have work in several states, it is important that the NRC and -the States have the same requirements for radiographic equipment and personnel dosimetry. Accordingly, the Agreement States will be required to implement requirements that are compatible with the NRC's final rule. In January 1987, Texas (an Agreement State) implemented requirements in its regulations which are similar to .those being proposed by the NRC. The action involves no new NRC resource requirements and is.not expected to have a significant economic impact on small businesses. Enforcement - Policy: Accompanying the final rule is a modification to the Commission's General Statement of Policy and Procedure for NRC Enforcement Actions, 10 CFR Part 2, Appendix C. This change which is to be made to Supplement VI, " Fuel Cycle and Materials Operations," provides an example by which violations of the requirements of the 10 CFR 'Part ?4 rule change may be categorized. A description of the change is provided in the Federal Register Notice. The purpose of this change to the enforcement policy is to give notice to licensees that a failure to have the equipment required by the rule may be considered a violation of significant regulatory concern. Coordination: The amenoments in this final rule have been reviewed and concurred in by a number of otner offices. The offices of Nuclear Material Safety and Safeguards, Nuclear Reactor Regulation, Governmental and Public Aff airs, Analysis and Evaluation of Operational Data, Enforcement, and Administration concur in these amenoments. ACRS and CRGR have no comments. The Office of the General Counsel has no legal objections. l l 1 l

op The Commissioners 5 Recommendation: That the Commission: 1.(a) Approve publication in the Federal Register of the final amendments to Part 34 (Enclosure A) that would become effeci.he one year after publication in the Federal Register. (b) Approve publication of the modification to Appendix C to 10 CFR Part 2 as an effective policy statement that would betone effective concurrent with Part 34 rule change. 2. Approve the staff's conclusions set forth in the Final Regulatory Flexibility Analysis (Appendix A to Enclosure A) that the benefits to the public health and safety that would result from the implementation of the proposed amendments outweigh the possible economic impact upon small entities. l The Chief Cour,sel for Advocacy of the Small Business Administration will be informed of this rulemaking and the reason for it as required by Section 605(b) of the Regulatory Flexibility Act. 3. Note that: a. An environmental assessment and a finding of no signif-icant impact have been prepared for this rule (Enclosure C). b. With respect to the Agreement States, this item will be made a matter of compatibility because it concerns ba-sic safety stardards, c. The Committee on Environment and Public Works, the Comnittee on Energy and Commerce and the Committee on Interior and Insular Affairs will be informed (Enclosure E). d. A public announcement will be issued when the Federal Register Notice is filed with the Office of the Federal Register (Enclosure F). e. Copies of the final rule will be distributed to affected licensees and other interested persons by the Office of Administration. f. The reporting and recordkeeping requirements contained in the regulation have been approved by the Office of Management and Budget, approval nuinber 3150-0007. l

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100mR/hr) and radio-graphert are required to post the boundaries of the high radiation areas with appropriate signs -(S 20.203(c)) and survey the restricted area bound-ary. Also, calculations based on the inverse sqpare law show that for a 200 Ci Iridium source the radiation field at a normal operator's position (with 21 foot guide tube and 25 foct control tube) is approximately 430 mR/hr. Trigger levels of much less than the 500 mR/nr specified would then trigger an alarm under normal radiography exposures. Also, alarm ratemeters that trigger while radiographer are conducting normal opera-tions would prove annoying and would likely be turned off. In view of these conditions, the trigger level should be set at 500 mR/hr. Those licensees that have a problem with this provision due to the need to work at nuclear power facilities where higher radiation levels may exist, may apply for an Exemption under S 34.51. With regard to the requirement to check the dosimeter alarm at 500 mR/hr on a daily basis, the provision has been rewritten to require a 05/22/89 36 Enclosure A 1 17590-013 ) calibration on an annual basis instead. The requirement for a daily check on the alarm remains unchanged. This can be provided by an electronic check point that corresponds approximately to the response of'a'500 mR/hr field. Finding of No Significant Environment Impact: Availability The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations'in Sub-part A of 10 CFR Part 51, that this rule is not a major Federal action significantly affecting the quality of the human environment and there-fore an environmental impact statement is not required. The final rule involves engineering design modifications to indust-rial' radiography devices and requires licensees to use only radiography i-devices and associated equipment that provide certain additional safety features. Radiographer are required to wear alarm ratemeters. No requirements for significant quantities of materials, water, electricity or other forms of energy have been identified and no environmental or 1. l radiation impacts are involved. 1' The environmental assessment and finding of no significant impact l on which this determination is based are available for inspection at the NRC Public Document Room, 2120 L Street NW., Lower Level, Washington, DC. Single copies of the environmental assessinent and the finding of no significant impact are available from Dr. Donald O. Nellis, Radiation Protection and Health Effects Branch, Division of Regulatory Applications, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, - Washington, DC 20555, telephone (301)492-3628. 06/05/89 37 Enclosure A 1 b h Papsrwork Reduction Act Statement L L This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). These requirements were approved by the Office of Management and Budget,. approval number 3150-0007. 1 Public reporting burden for this collection of information is esti, mated to average 34 hours per response, frecluding the time for reviewing. instructions, searching existing data sources, gathering and maintaining 1 the data needed, and completing and reviewing the collection of informa-l tion. Send comments regarding this burden estimate or any other aspect of.this collection of information, including suggestions for reducing ' j this burden, to the Records and Reports Management. Branch (P-530), U.S. Nuclear Regulatory Commission, Washington, DC 20555; and to the Paper-work Reduction Project (3150-0007), Office of Management and Budget. Washington, DC 20503 Regulatory Analysis The Commission has prepared a regulatory analysis on this final rule. The analysis examines the costs and benefits of the alternatives considered by the Commission. The regulatory analysis is ave'lable for inspection in the NRC Public Document Room, 2120 L Street NW, Lower Level, Washington, DC. Single copies may be obtained from Donald O. Nellis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telcphone (301)492-3628. 06/05/89 38 Enclosure A M 4 i t ~,. Regulatory Flexibility Analysis ' The NRC has prepared a final regulatory flexibility analysis of the impact of this rule on small entities as required by Section 604 of the ' Regulatory Flexibility Act. The analysis, which is set out in Appendix'A of this document, indicates that this rule could have an economic impact of about $5,113 initially, and $1,188 annually on each radiography licen- ~ see, 90% or more of which are considered to be small entities. These costs are not considered to be overly burdensome in light of the possible benefits derived. Modification of Enforcement Policy The Commission is modifying its General Statement of Policy and Procedure for NRC Enforcement Actions, 10 CFR Part 2, Appendix C (Enforcement Policy) to reflect the Commission's amendment of 10 CFR Part 34. The change to the Enforcement Policy is being published concurrently witn the new rule. The modification to the Enforcement Policy is being made at this time to Supplement VI " Fuel Cycle and Materials Operations" to put licensees on notice that the failure to implement the requirements for dosimetry and equipment by the required date may be corisidered a violation of significant regulatory concern. The example is to be used as guidance in considering Severity Level III violations of the requirements. The example for Severity Level III is significant because it represents failures associated with the use of equipment and dosimetry designed to minimize overexposure from radioactive materials. 06/05/89 39 Enclosure A f [7590-01] L Backfit Analysis This final rule does not modify or add to systems, structures, com- ~ ponents, or design of a facility; the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct or operate a facility. Accordingly,-NRC has determined. that the backfit rule 10 CFR 50.109 does not apply to this final rule, and i therefore a backfit analysis is not required for this final rule because these amendments do not involve provisions which impose backfits as defined ~in 10 CFR 50.109(a)(1). List of Subjects in 10.CFR Part 2 and 10 CFR Part 34 Part'2 - Administrative practice and procedure, Antitrust, Byproduct material, Classified information, Civil penalty, Enforcement, l l Environmental protection, Nuclear materials, Nuclear power plants and reactors, Penalty, Sex discrimination, Source material, Special nuclear l l material, Violations, Waste treatment and disposal. L Part 34 - Byproduct material, Incorporation by reference, Packaging and containers, Penalty, Radiation protection, Radiography, Reporting and recordkeeping requirements, Scientific equipment, Security measures. For the reasons set out in the preamble and under the authority'of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is adopting the following amendments to 10 CFR Part 2 and 10 CFR Part 34: 06/05/89 40 Enclosure A I i [7590-01]- w . e PART 2 - RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDI'NGS 1. The authority. citation for Part 2 continues to read in part as 1 follows: AUTHORITY: Sec'. 161, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841). 2. Appendix C, Supplement VI, is modified by adding example 9 to paragraph C to read as follows: Appendix C -- General Statement of Policy and Procedure for NRC Enforcement Actions A A A A A Supplement VI --- Severity Categories C. Severity III. 9. Failure, during radiographic operations, to have present or use radiographic equipment, radiation survey instruments, and/or personnel monitoring devices as required by Part 34. PART 34 - LICENSES FOR RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR RADIOGRAPHIC OPERATIONS i 1. The authority citation for Part 34 is revised to read as follows: AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841). 05/22/89 41 Enclosure A I I [7590-01] Section'34.32 also issued under.sec. 206, 88 Stat. 1246 (42 U.S.C. 5846). l For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. l 2273); SS 34.20(a)-(e), 34.21(a) and (b), 34.22, 34.23, 34.24, 34.25(a), i (b) and (d), 34.28, 34.29, 34.31(a) and (b), 34.32, 34.33(a), (c), (d) l and (f), 34.41, 34.42, 34.43(a), (b) and (c) and 34.44 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b); and SS 34.11(d), 34.25(c) and (d), 34.26. 34.27, 34.28(b), 34.29(c), 34.30, 34.31(c), 34.33(b) and (e) and 34.43(d) are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)). 2. A new S 34.20 is added under the Equipment Control heading in Subpart B to read as follows: S 34.20 Performance requirements for radiography equipment. Equipment used in industrial radiographic operations must meet the following minimum criteria: (a) Each radiographic exposure device and all associated equipment must taeet the requirements specified in American National Standard N432 " Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," 1981 (published as NBS Handbook 136). This publica-tion has been approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a). This publication may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402 and from the American National Standards Institute, Inc., 1430 Broadway, New York, New York 10018, Tele-phone (212) 642-4900. Copies of the document are available for inspection at the Nuclear Regulatory Commission Public Document Room, 2120 L Street 06/05/89 42 Enclosure A I I NW., Lower Level, Washington, DC 20555. A copy of the document is also on ~ file at the Office of the Federal Register, 1100 L Street NW., Room 8301, l Washington, DC 20408. _(b) In addition to the requirements specified in paragraph (a) of this section, the following requirements apply to radiographic exposure devices and associated equipment. (1) Each radiographic exposure device must have attached to it by the user, a durable, legible, clearly visible label bearing the-- (i) Chemical symbol and mass number of the radionuclides in the device; (ii) Activity and the date on which this activity was last measured; (iii) Model number and serial number of the sealed source, and (iv) Manufacturer of the sealed source. (v) Licensee's name, address, and telephone number. (2) Radiographic exposure devices intended for use as Type B tran-sport containers must meet the applicable requirements of 10 CFR Part 71. (3) Modification of any exposure devices and associated equipment is prohibited, unless the design of any replacement component, including source holder, source assembly, controls or guide tubes would not compromise the design safety features of the system. (c) In addition to the requirements specified in paragraphs (a) and (b) of this section, the'following requirements apply to radiographic exposure devices and associated equipment that allow the source to be moved out of the device for routine operation. (1) The coupling between the source assembly and the control cable must be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling must 06/05/89 43 Enclosure A [7590-01] P .also be such that it cannot be unintentionally disconnected under normal .and reasonably foreseeable abnormal conditions. l (2) The device must automatically secure the source assembly when it is cranked back into. the fully shielded position within the device. This securing system may only be released by means of a deliberate opera-tion on the exposure device. l (3) The outlet fittings, lock box, and drive cable fittings on each radiographic exposure' device must be equipped with safety plugs or covers which must be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter. (4) Each sealed source or source assembly must have attached to it I i or engraved in it, a durable, legible, visible label with the words: " DANGER - RADI0 ACTIVE." The label must not interfere with the safe opera-tion of the exposure device or associated equipment. (5) The guide tube must have passed the crushing tests for the con- { trol tube as specified in ANSI N432 and a kinking resistance test that j closely approximates the kinking forces likely to be encountered during use. (6) Guide tubes must be used when moving the source out of th.e device. (7) An exposure head or similar device designed to prevent the l source assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during radiographic l operations. (8) The guide tube exposure head connection must be able to with-stand the tensile test for control units specified in ANSI N432. l 06/05/89 44 Enclosure A 1 4 .. s (9) Source changers must provide a system for assuring that the source will not be accidentally withdrawn from the changer.when connect-4 ing or disconnecting the drive cable to or from a source assembly. -(d) All newly manufactured radiographic exposure devices and asso-ciated equipment _ acquired by licensees after (insert a date 1 year from the effective date of the final rule) mJst Comply with the requirements of this section. (e) All radiographic exposure devices and associated equipment in use after (insert a date 5 years from the effective date of the final rule) must comply with the requirements of this section. 3. In S 34.21 the existing paragraph is designated as paragraph (a) and a new paragraph (b) is added to read as follows: 6 34.21 Limit on levels of radiation for radiographic exposure devices and storage containers. a (b) Paragraph (a) of this section applies to all existing equipment received prior to (insert a date 1 year after the effective date of the final rule). Five years after (insert the effective date of the final rule), 6 34.21 applies only to storage containers (source changers) and all other radiographic equipment must meet the requirements of S 34.20. 4. A new neading " REPORTING" is added and a new $ 34.30 is edded under that heading to read as follows: $ 34.30 Reporting requirements. (a) In addition to the reporting requirements specified under other sections of this chapter, each licensee shall provide a written report to the U.S. Nuclear Regulatory Commission; Division of Industrial and Medical 06/05/89 45 Enclosure A l I f {pgg g y--- - - . ( Nuclear Safety; Medical, Academic and Commercial Use Safety Branch; Washington, DC.20555, with a copy to the Director, Office for Analysis and l Evaluation of Operational Data, U.S. Nuclear Regulatory Commission, Washington, DC 20555, within 30 days of the occurrence of any of the following incidents involving radiographic equipment: (1) Unintentional disconnection of the source assembly from the control cable. (2) Inability to retract the source assembly to its fully shielded position'and secure it in this position. (3) Failure of any component (critical to safe operation of the device) to properly perform its intended function, and which could potentially-cause a radiation hazard, and which is not correctable as part of the licensee's routine maintenance program other than by replacement. (b) The licensee shall include the following information in each report submitted under paragraph (a) of this section: (1) A description of the equipment problem. (2) Cause of each incident, if known. (3) Manufacturer and model number of equipment involved in the incident. 4 (4) Place, time and date of the incident. (5) Actions taken to establish normal operations. (6) Corrective actions taken or planned to prevent recurrence. (7) Qualifications of personnel involved in each incident. (c) Reports of overexposure submitted under 10 CFR 20.405 which involve failure of safety components of radiography equipment must also include the information specified in paragraph (b) of this section. 06/05/89 46 Enclosure A [7590-01] 1. e-5. In S 34.33 paragraph (a) is revised to read as follows and a f new paragraph (f) is added to read as follows: S 34.33' Personnel monitoring. (a) The licensee may not permit any individual to act as a radio-grapher or a radiographer's assistant unless, at all times during radio-graphic operations, each such individual wears a direct reading pocket dosimeter, an alarm ratemeter and either a film badge or a thermolumine-scent dosimeter (TLD) except that for permanent radiography facilities where other appropriate alarming or warning devices are in routine use, the wearing of an alarming ratemeter is not required. Pocket dosimeters must have a range from zero to at least 200 milliroentgen'and must be recharged at the start of each shift. Each film badge and TLD must be assigned to and worn by only one individual. R R R R R (f) Each alarm ratemeter must-- (1) Be checked to ensure that the alarm functions properly (sounds) prior to use at the start of each shift; l-(2) Be set to give an alarm signal at a preset dose rate 500 mR/hr. (3) Require special means to change the preset alarm function; and (4) Be calibrated at periods not to exceed one year for correct response to radiation: Acceptable ratemeters must alarm within plus or minus 20 percent of the true radiation dose rate. 6. In Appendix A, Item II.C, "Use of personnel monitoring l equipment," is revised to include: Appendix A II 06/05/89 47 Enclosure A l I [7590.01) I } C *** l 3. Alarm ratemeters n n n n n l Dated at Rockville, MD, this day of _ 1989. For the Nuclear Regulatory Commission. l l Samuel J. Chilk Secretary of the Commission 06/05/89 48 Enclosure A i ] [7590-01) APPENDIX A TO THIS DOCUMENT -- REGULATORY FLEXIBILITY ANALYSIS FOR AMENDMENTS TO 10 CFR PART 34 ON SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC. EQUIPMENT The Nuclear Regulatory Commission is amending its regulations that apply to industrial radiography. These amendments impose additional safety performance standards on radiographic equipment and radiographer are required to wear alarm ratemeters. In addition, the amendments require reporting of failures of radiography equipment to meet safety performance standards in the field. Industrial radiography performed in the field has been of concern to the NRC and the Agreement States for over 20 years, in part because of its high incidence of overexposure (4 to 5 times that of other radiation workers), and in part because of the potential for serious consequences to both the public and radiographer due to the.high activity of the radioactive sources used in this industry. Among the actions corsidered by the NRC to help alleviate the situation are: (a) A training manual for radiography personnel, (b) Improved training programs for individual radiographer, (c) Increasing inspection time observing actual radiographic operations, L. (d) Providing additional guidance for reporting events as required I by 10 CFR, and (e) Establishment of safety requirements for radiographic equipment. The amendments in this rulemaking fall within category (e) above. l They are designed to reduce the potential for overexposure by the j 06/05/89 49 Enclosure A ) [ .[7590-01)~ a -. s l i, i, imposition of safety performance standards on radiographic exposure devices and associated equipment and by providing some redundancy in detecting exposed sources by requiring the use of alarming ratemeters. A total of approximately 1,100 radiography licenses are currently in effect, approximately one-third have been issued by the NRC and the other two-thirds by the Agreement States. Based upon a recent survey of some 355 NRC radiography licensees and discussions with Agreement State personnel in California, Louisiana, and Texas, (which contain most of the non-NRC radiography licensees) the staff has concluded that approximately 90% of all radiography licensees have annual receipts of less than $3.5 million, the criterion for defining "small entities," specified in Section 605(b) cf the Regulatory Flexibility Act of 1980. Most of the radiography licensees are in the business of nondestruc-tive testing in which radiography represents only a part of their total income. A few small firms work only in radiography. In spite of their i classification as small entities, the NRC survey cited above indicated that 76% of the licer. sees had annual receipts of over $500K and most of 1 the remainder had annual receipts exceeding $250K. l l The estimated costs to individual licensees resulting from these l amendments consist of an initial cost of $3,636 for the purchase of radio-graphy devices and $1,477 for purchase of alarm rate meters, plus an annual cost of $1,188 for replacement of devices and alarm dosimeters, annual calibration of alarm dosimeters, annual maintenance costs, and reporting and labelling requirements. 06/05/89 50 Enclosure A I, '.. s A breakdown in the annual cost per licens:e given cbove is as follows: Replacement of exposure devices (over $ 404 and above the present cost) Replacement of alarm ratemeters i 295 Calibration of alarm ratemeters -$ 227 Ratemeter battery replacement 5 164 Reporting and labelling requirements $ 98 $1188 Although the majority of the licensees fall within the category of- "small entities" as defined by the NRC, the Commission believes that the 1 initial and annual' costs of the new rulemaking which are described above should not have a significant economic impact op most of the licensees because the costs are small compared to their annual receipts.

Further, the Commission has concluded that the benefits that would result to radio-graphers and to the general public as a result of these amendments out-weigh the small cost to the licensees. This final rule does not duplicate or conflict with other Federal rules.

l e 06/05/89 51 Enclosure A r! w l a l REGULATORY ANALYSIS FOR AMENDMENTS TO 10 CFR PART 34 ON SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC EQUIPMENT 1. Statement of the Problem A total of approximately 1,100 firms currently possess radiography licenses to perform industrial radiography (either at fixed locations or at multiple l locations) using gamma rays for the nondestructive testing of pipeline weld joints, steel structures, boilers, aircraft parts and other related items and structures. Approximately one-third of these licenses have been issued by the Nuclear Regulatcry Commission and the remaining two-thirds by Agreement States. The firms employ an estimated 5,000 radiographer and radiographer assistants on a full-or part-time basis, but it is estimated that another 5,000 radio-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 compar.ies) are in use, producing tens-of-millions of radiographic pictures per year and utilizing in excess of $20 million worth of radiographic film per year. In general the industry may be characterized as consisting of firms that conduct their radiography at a single location (36%) and those that conduct their radiography at cultiple locations (64%). Approximately 90% are consid-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 radiographer and devices generally perform nondestructive testing by a variety of methods, only one of which is radiography; and the operators are trained in other methods of nondestructive testing as well. Radiation exposures received by radiographer have been a concern of the NRC and Agreement States for some time. During the years 1979 through 1983, radiographer overexposure averaged 18% of all overexposure although 1 ENCLOSURE B \\ l radiographer represent only 4% of all radiation workers. These overexposure 'are usually a result of improper procedures or equipment problems, but the numbers due to each are.not well known. a NRC exposure data ir.dicate that equipment problems contribute to'approxi-mately 40% of all reported overexposure events. Texas data indicate a much lower incidence of equipment problems (21%), but exhibit such a high incidence 5 of " unknown" reasons for overexposure (65%) compared to (15%) for NRC d6ta that it is probable that additional equipment problems were contributors to .some of these " unknowns." In 1978 the NRC published an Advance Notice 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 exponres 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 Con'struction 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 draft recommendations for improving radiography safety. The Steering Committee subsequently established four task forces to address various aspects of the pro 31em: Radiographic Equipment Design Safety; Training and Certification of Radiographer; Inspection; and Collection and Analysis of Incident 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 radiographer and to the general public. Although 2 ENCLOSURE B rl a o, ; the' consensus standard mentioned above was published in 1981, in the very com. ~ j: 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. Objectives These amendments are intended to achieve reductions in exposures to radiographer 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 1 hose areas where the task force has identified problems and suggested solutions. Incorporation of performance standards in the regulations has the advantage of requiring indus-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 dards and a requirement for radiographer to wear alarm dosimettes; simultaneously issuing a regulatory guide that endorses the standard N432 supplemented by additional perfor-mance standards and acceptable methods for meeting the alarm dosim-etry requirement. (3) Incorporate the described requirements in the regulations. This involves incorporation by reference of the consensus standard N432 3 ENCLOSURE B I i+, in the regulations, and the incorporation of such other performance standards as were recommended by the equipment task force, plus a requirement for radiographer 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 overexposure would probably remain about the same, and the probability of serious incidents involving members of the public as well as workers would also be unchanged. This alternative leaves the implementation of the consensus standard, NBS Handbook 136, up to 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 a requirement for radiographer to wear alarm rate-meters ; simultaneously issuing a regulatory 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 f a. a ] j The NRC estimates a staff effort on the order of 12 person eonths at a 1 cost of $7000 per person-month for a total NRC implementation cost of approximately 584,000. 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 radiographer and l 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 1,100 radiogr;phy 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 are approximately $14.2 millier 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 req'uirements in the regula-tions. This involves incorporation by reference of the consensus standard N432 in the regulations, and the incorporation of such other performance standards as were recommended by the equipment task force, plus a requirement for radiographer to wear alarm ratemeters. 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 projected to be somewhat less than that identified in Alternati';e 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 ENCLO5URE B r g- .'y The'ccst to industry includes all of-the costs identified under Alternative 2 plus-the' cost associated with the purchase and replacement of-radiographic exposure devices. -These latter costs are estimated at $4 -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 estimetes are presented'in Appendix A. Coupled with the' costs discussed under Alternative 2, this produces industry-wide costs on a 1989 present worth basis of approximately $21.4 million. A corresponding value-for individual licensees is on the order of $19,503. No legal or other barriers to the adoption of this alternative have been identified. 5. Decision Rationale The staff proposes that Alternative 3 be adopted. Alternative 1 is not l selected because the objective of this. action is to improve public health and safety through the reduction of exposures to radiographer and to the general public by the application of safety performance standards for radiographic exposure devices and the required wearing of alar'm 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 accomplish the desired objective. While the costs of the proposed amendment have been discussed above l and are amplified in Appendix A; the benefits have not.- The benefits to be derived from a reduction in potential overexposure by the adoption of these amendments in the regulations is difficult to evaluate on a monetary basis. In general, it is not meaningful 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 e t Y--__-_____--__-_-------__ -Also, in many of the reported incidents the cause of the overexposure is either unknown or not reported. A more appropriate approach to oenefits 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 200 rems and a potential for a much larger dose that was avertd by luck; or the incident in Morocco in 1984 that resulted in the deaths of L persons, 6. Implementation The NRC expects that the various requirements of the rule will be made effective or:e 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 requirements of the rule. All devices in use prior to this date must comply with the requirements of the rule after five years from the effective date of the rule. This implementation schedule was chosen to give manufacturers time to. incorporate the new provisions of the rule in the new devices and to allow users time to evaluate 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 impose 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. This action will affect sections of 10 CFR Part 34 of the Commission's regulations. No effects on other existing or preposed requirements have been identified. 7 ENCLOSUPE B I I I t. l APPENDIX A COST ANALYSIS i) Replacement of Radiography Exposure Devices The costs of incorporating the safety performance criteria for radiographic equipment were developed in 1984 by the Task Force on 1 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. Independent of the proposed rule, the staff assumes that there is a continuous need to periodically replace 3500 radiographic exposure devices as they wear out. Based on an assumed operating life of ten years per device 2 it is estimated that on average 10% or 350 devices will be replaced annually. Therefore, a major incremental cost resulting from this proposed requirement is the cost of the additional safety features incurred during these annual replacements. This is estimated at 51268 per device, the basis of which is detailed in Table 1. The average annual cost to indu'stry is estimated at 5444,000 ((350 devices) x 51268)). On a per licensee basis the average annual cost is $404. For reasons explained below, it is assumea these costs commence in the year 2000. The staff also recognizes that when this requirement becomes effective in 1995 there will be a need for industry to accelerate its replacement of exposure devices. This is because even devices that are serviceable and have useful remaining lives will have to be discarded in 1995 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, 1984. 2The staff recognizes that the useful life per device can very dramatically depending on such factors as its usage rate, variations in model designs, and site specific conditions. Howe ~ver, 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 f R staff looked at a ten year period encompassing the 1990 to 1999 time frame. 3 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 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 rule would purchaf t 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, j 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 1 Assuming the purchase of one ratemeter for each of the estimated 5000 l i i working radiographer and radiographer assistants

• at an estimated cost of i

$325 each, the total cost to the industry would oe $1,625,000. For each of the estimated 1100 licensees the cost would be $1477. 3) Annual Cost for Alarm Ratemeter Replacement l i 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 industry will then be $325,000 and to eat.h of the 1100 licensees $295. i 4) Annual C6st for Alarm Ratemeter Calibration i i The average cost of calibration of alarm ratemeters is estimated to be ) $50 each, based on information from persons who provide such services. l 3Since this analysis takas into account the incremental costs incurred through 1999, the preceding analysis begins capturing annual costs commencing in the year 2000, 9 ENCLOSURE B 1 I,

i Since the rule requires an annua' calibration, the annual cost of calibrating 5000 ratemeters would be $bu,000 to the industry ~ and $227

~ for each licensee, 5) Annual Alarm Ratemeter Battery Replacement' Battery life for alarm ratemeters depends on the count rate, but the - y average lifetime appears to be 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 1100 licensees $164. 6) Annual Reporting Requiretaents Based on records af past incidents involving radiographic exposure devices, it is estimated that the new reporting requirements, specified in S34.30 could result in an additional 50 reports annually. Using an estimate of one hour per report and a cost of $60 per hour the annual cost to the industry would be $3000 or approximately $2.75 fo'r each licensee. 7) Annual Labelling Requirements 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 cevices 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. L 10 ENCLOSURE B l I 3 1 1 1 ) t 0 r 4 ope r R a f e 0 0 0 0 0 e osY 5 5 5 5 5 0 c t. 7 7 3 3 3 5 r .ir 8 8 3 o one f I UP ~ d ) ks y de l a T e~ v t l m a o o t r v r n a n f ey p i mcr e d ena s s e cee 5 5 1 1 1 1 i p l q 2 2 0 0 0 0. d t auY e t a per t s d ere n o A RFP e c s ( m g e m n e u i l a pt m t a ir ma i t c m n iiv i e i i f v t at m i i s ed r e C rs rE l f ue 0 0 0 0 0 0 e s. bel e osc 0 0 0 0 0 0 tt uy ah n hl ct c oi 5 5 5 5 5 5 i n .pv 3 3 3 3 3 3 ri tb a axe co ,m ef m 'r E D P e vo i r x es i o o ss rk b ua dcn fr k ne dbi e P c il n o b ae ya g l dc n ) f a x i ee oh i t e( a g ( rv bg li r nt ar k o o ai 0 l p R n 0 0 0 0 a d cr r U 5 5 2 0 0 0 ~t e oh o t 3 1 1 1 o rd l t c sr 0 T an n oe 0 0 0 0 aa. ,d ee I CP 1 5 5 5 a i yrivi i rl epod r ebt pmn o t mii f ierne rsc s t h cs t s t yn aeet o i l i n e cl od w n o cl nt ne C le odi ni a u n k b y et h aamoar a l eri nt mt r 1 l n l us oid e rgor we c oif oy od bco i e l e aep t t r f prfl e ed vs ayc up r e l i b a l l o d rl e oa ef psm a t b e mee enn sr po ge T g ai ecd pon t eust r rh rrl o o c m gtbl s i P o es ue ec iys nsupas et t p l oi l l tli i e e c oe osh ob e abn wt ye c c e c r s ric mma o et cr l l d ert n* r n k r th t sr oeh aa u n cu nt e nsu t sc l l i f un mi o o oo oih ooo use ouuaoo rr S C L s C wt Cps Aam fPGSSC oe e f t h ri T12345 er PC a b c d. e f 1 1 l f L...; .i I Table 2 Summary of Costs y Alternative 2 Alternative'3 -Industry Licensee. Industry ?.icensee 1(a) Purchase of radiography $ $ $4,000,000 5 3636 devices

• 1(b) Annual replacement of 4M,000 404

. radiography ~ devices ** 2(a) Purchase of alarm rstemeters*** 1,625,000 1.477 1,625,000 1,477 2(b) Annual ratemeter rep 1acement**** 325,000 295 325,000 295 3) Annual - ratemeter calibration **** 250,000 227 250,000 227 4). Annual ratemeter battery replacement **** 180,000 164 180,000 164 ^ 5) AnnualReporting requi rements *** 3,000 3 3,000 3 6)- Annuallabelling requirements **^ 105,000 95 105,000 95 1989 Present Worth Total Cost ***** $14.2 Million $12,900 $21.4 Million 519,450

• This' cost is already expressed on a 1989 present worth basis.
  • Annual cost assumed to commence in year 2000 and continue for 20 years.
    • 0ne time up front cost incurred in 1990.
      • Annual costs ' assumed to commence in year 1990 and continue for 30 years.
        • 1989 present worth based on a 5% real discount rate.....capters cests between 1990 and 2020.

12 ENCLOSURE B I l ENVI?0NMENTAL ASSESSMENT AND FINDING 0F 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 to industrial radiography to require ac:ditional safety features for industrial radiographic equipment and ' Muire that radiographer wear alarm ratemeters. Envir0nmental Assessment Identification of Final Action 10 CFR Part 34 specifies the radiation safety requirements for radiographic operations, including performance requirements for industrial radiographic devices, personal radiation safety requirements for radiographer 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 additienal personnel radiation monitoring requirements for radiographer (Section 34.33). Need for the Final Action The number of radiation overexposure and potential overexposure of both f radiographer 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 sources used in industrial radiography are sufficient to cause serious injury or death. Although a voluntary consensus standard that incorporates many of the proposed performance requirements has been available since 1981, there is i 1 Enclosure C l =. L 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 that regulatory action is needed at this time. Environmental Impacts of the Final Action The revision of 10 CFR Part 34 should have no environmentally significant impact. The final performance requirements will involve engineering design modifications and will require radiographer 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 l 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 overexposure of radiographer and the general public would continue unabated. A second alternative considered was to incorporate the additional performance requirement into a regulatory guide. However, since regulatory i 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 Enclosure C l 1 li 1 Agencies and Persons Consulted l L Consultations on the rule have been held with Agreement State representatives from California, Louisi.ana and Texas. Also, discussions regarding the content and purpose of the rule were held with representatives of radiographic device manufacturers add with representatives of nondestructive testing companies involved in radiography. finding of No Significant Impact The Commiscion has determined not to prepare an environmental impact statement for the final rule. Based on the foregoing environmental assessment we concluded that this amendment will not have a significant effect on the quality of the environment. e 3 Enclosure C - - +. ~ Document Namei 10 CFR 34 EhTIR ASSE ENCL C Requestor's ID: COATES Author's Name: hTLLIS, D Document Comments: kTN ECS 2/17/89 KEEP SHEET WITH DOCUMENT l \\ m 3 l ANALYSIS OF COMMENT 5 Enclosure D ( ANALYSIS OF COMMENTS IDENTITY OF COMMENTERS 1 Docket File Comenter Number Commenter 1 State of California i (Div. of Occupational Safety & Health) Yan Nuys, CA I 2 MQS Inspection Inc. Hartford, CT 3 Liberty Mutual Hopkinton, MA 4 MQS Inspection, Inc. Hartford, CT 5 NDTMA Bethel Island, CA 6 Americon Holding Company, Inc. Copley, OH 7 MQS Inspection Inc. Hartford, CT 8 Consumers Power Jackson, MI 9 NDTMA Bethel Island, CA 10 Riley-Beatrd, Inc. Shreveport LA 11 Amersham Corporation Burlington, MA 12 ASNT Columbus. OH 13 Edwards Pipeline Testing, Inc. Tulsa, OK 14 Combustion Engineering Windsor, CT l ANALYSIS OF COMMENTS (Continued) IDENTITY OF.COMMENTERS Docket File Cownenter Number Commenter 15 MQS Inspection Inc. Elk Grove Village, IL 16 Westinghouse Electric Corporation Pittsburgh, PA l 17. Empire Steel Castings, Inc. Reading, PA 18 Amersham Corporation Arlington Heights, IL 19 Industrial NDT Company, Inc. North Charleston, SC 20 MQS Inspection, Inc. Hartford, CT l 21 Texas Departmerit of Health Austin, TX 22 Bethlehem Steel Corporation Bethlehem, PA 23 Air Tr.nsport Association Washington, DC 24 NDTMA Bethel Island, CA 1 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 29 Richardson X-Ray, Inc.. Alhambra, CA 2 l t L_ - -- _ _ _ I ) ANALYSIS OF COP 94ENTS (Continued) 1 IDENTITY OF COMMEN'JERS Docket File Commenter Number Comenter 30 Tech /0PS, Inc. Boston, MA 31 MQS Inspection Inc.. Roseville, MN l 32 Globe X-Ray Services Tulsa, OK 33 Ultrasonic Specialists, Inc. Houston, TX 34 Connex Pipe Systems Marietta, OH 35 Harrison Steel Castings, Co. Attica, IN 36 Mason & Hanger-Silas Mason Co., Inc. Middletown IA 37 Northwest Testing Laboratories, Inc. Portland, OR 38 NASA 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 f ANALYSISOFComENTS(Continued) f IDENTITY OF COMMENTERS Docket File I Connenter Commenter Number Eastern Idaho Vocational-Technical 45 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 50 Larry Van Fleet Richland, WA 51 Electro Alloys. Inc. 52 E. Lewis Cook & Associates Chattanooga, TN 53 Department of the Air Force Kelly AFB, TX Pensacola Testing Laboratories, Inc. 54 Pensacola, FL 55 Dupiteate of 54 56 U.S. Nuclear Regulatory Connission Region I King of Prussia, PA 57 Geotge M. Corney Hilton, NY 58 Riley-Beaird, Inc. Shreveport, LA 59 Litton, Ingalls Shipbuilding Pascagoula, MS 4 i ANALYSIS OF COMMENTS (Continued) IDENTITY OF COMMENTERS l Docket File { Commenter Number Commenter l 60 Industrial NDT Services Indianapolis, IN 61 No Identification 62 Duplicate of 32 l 63 L.H. Sherwin Cincinnati, OH 64 Department of the Air Force Bolling AFB, DC 65 Capital X-Ray Services, Inc. Tulsa, OK 66 Union Carbide Corporation North Kansas City, MO 67 American Airitnes Tulsa, OK 1 68 A. Santascelli Burke, VA ' 69 Quad City Testing Laboratory, Inc. l Devenport IA l 70 Fabrication Inspection Services l Harvey, LA 71 MQS Inspection, Inc. Roseville, MN 72 Edwards Pipeline Testing, Inc. Tulsa, OK 73 Professional Welding Associates Inc. rewaunee, WI 74 Emar Enterprises El Cajon, CA 1 1 75 Joseph F. Bush Avondale Industries Inc. New Orleans, LA i 5 l ANALYSIS OF COMENTS (Continued) IDENTITY OF COMMENTERS Docket File Commenter Number Commenter 76 Boeing Connercial Airplane Co. Seattle, WA 1 l 77 Tenneco Gas Transportation Houston, TX 78 Alabama Power Mobile, AL 79 Central Testing Co., Inc. Lake Charles, LA I 80 ASNT(Survey) Columbus, OH 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 86 Source Production & Equipment Co., Inc. St. Rose, LA ^ 87 No Identity Given Orlando, FL 88 Teledyne CAE Gainsville, FL 89 RTS Technology, Inc. North Andover, MA i, l. ANALYSIS OF COMMENTS SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC 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 letters discussed above, the AMERICAN SOCIETY FOR NONDESTRUCTIVE TESTING, INC., (ASNT), a major trade organization which represents 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 of 7000, the majority cf 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 th's docket. 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 current analy-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 T o t a l re c t i ve d ----- ---------- ---------- ----------- ----- 8 9 Comment on another rule ---------------- 4 Request for extension only ------------- 5 Duplicates ----------------------------- 3 Survey letters without comments -------- 8 Request for copy of rule --------------- 1 21 04/26/89 7 Enclosure D N2t va l i d ccmme nt l ette rs ------------------------------ 68 Additional ASNT survey' responses ---------------------- 399 GENERAL DISCUSSION The proposed rule contained issues expressed both in sections, such as $34.20; paragraphs, such as $34.20 (c); and sub paragraphs, such as $34.20(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 make comments on all of the issues but a brief review of the comment letters from many of the larger radiography firms indicate that they responded to I. comments on at least 10 of the 27 issues. 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 cf them. S 34.20(a) DEVICES MUST MEET REQUIREMENTS OF ANSI N432 l Twenty four comments were received on this requirement, eleven or 46 percent approved and thirteen or 54 percent were opposed. Principal comments were as i follows: APPROVED Commenter 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 announcing the change. 18 Stacidard specifications are the basis for well constructed radiographic equipment. 04/26/89 8 Enclosure D l E__ _ _ _ _ _ I, +, .= APPROVED (Cont'd) Covmenter 30~ Consensus standard assures practicability of the requirement. 86 Agree with all parts of the standard except the requirement for-section on radiation levels. ' 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. 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 overexposure non-existent. 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 having to carry the device longer and closer to the body. 04/26/89 9 En:losure D t E' { 1 OPPOSED (Cont'd) Commenter l Feels that the conditions of the standard should be restricted to 88 field device use only. Staff Response: l The principal objection is 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 shielding material anc radio-graphic exposure devices measured four inches or more from the source to the outside of the device. With the use of depleted uranium shielding beginning in the mid sixties it was possible to meet the existing radiation levels with devices that measured around two inches from source to surface 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. 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-dard were published in 1981, that identical levels have been a part of the international ste.ndard since 1977, and that the radiography industry has not been unaware of the new requirements. The fact that several radiographic exposure 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 particularly since the standard applies to portable, mobile, and fixed exposure devices. The staff see no reason to make any changes in this provision. S 34.20(b)(1) EXPOSURE DEVICE LABEL A total of fourte a.omments were received on this issue, all but two approved. The negative comments indicated that the markings should be such that 04/26/89 10 Enclosure D th:y cannot be nutilat:d beycnd identification and that the upkeep of proper markings could be costly. The other comment was that the isotope manufacturer must be responsible to provide the customar with the proper label and that guidelines should be prepared to specify label dimensions and method of attach-ment to allow device manufacturers a standard for design specifications. Staff Response: Current industry practice is for the manufacturer to provide a plate to the exposure device user with the source r. hanger 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, add ess end telephone number of the owner will be included on the label. It is the responsibility of the user to keep this information 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 of these two issues. One manufacturer however questioned in whose judgment would modifications affect system design and safety. The manufacturer also as~ked if this implies that no roodifications' may be made without resubmission of designs to the proper NRC or Agreement state authority. Staff Response: No changes are to be made in 6 34.20(b)(2). In regard to me comment concerning modifications, the intent of this provision is to prohibit users frcm making modifications that coc'id 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 C2NECTION Twenty two comments were received on this requirement. Fifteen, or 68 percent of the commenters approved and seven, or 32 percent were opposed. The principal comments were as follows: 04/26/89 11 Enclosure D I ii -_-_-- _ _x APPROVED Qg]Lenter 7 Approve but recommend that whatever coupling is adopted that it be made mandatory and standardized to the point of interchangeability regardless of the manufacturer. Tnis 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 is more appropriate. 19 An improved standardized design should greatly reduce inadvertent overexposure. 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 wording 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 abnormal situations. OPPOSED Commenter 21 o Don't like the wording. Suggest that we change from technical specifications to performance requirements. l 04/26/89 12 Enclosure D I h 4 OPPOSED (Cont'd) i Commenter 42 Unsure of the meaning or'which connectors would be accepted. 53 The wording is ambiguous. Also, it should be specified that a positive force is required for a disconnect. Suggests that wording might specify motion in two orthogonal directions. 64 o This would require moving parts that could fail. 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 Commenter 7 Should be on all cameras but with the understanding that it is only a guide. 8 Experience has shown that they are not reliable. 04/26/89 13 Enclosure D APPROVED (Cont'd). f Commenter 10 Not needed, if survey meter is used. 13 Could lead to false indications. The additional parts needed could fail. 18 May be an additional guide but it can also fail. Don't think there 1. are adequate statistics to show that-it increases safety. 19 Those~in use have not proven to be fail-sais. Retrofitted ones could be worse. l l 22 Should not be required even though the idea 'is good, --- radiographer won't use survey meters. 28 May. result in negative impact as radiographer 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 disadvantage at the present time --- a crutch to use instead of a survey meter.

38 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. l 04/26/89 14 Enclosure D !l 1-APPROVED (Cont'd) Commenter 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 Should postpone this requirement until data are acquired to show how it will improve safety. 79 Keep ca.neras 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 not fail. It was also pointed out at this meeting that source position indi-cators consisting of red and green lights were installed on some devices as early as 1958. These failed so frequently that the NRC asked manufacturers to remove them. Also, a provision for such an indicator has been proposed for inclusion in the next revision of the International Radiography Standard,150 3999, by the French delegation but there appears to be little support from other countries. In view of the continued oppostion and past experience with these indicators the staff have agreed to remove the provision. i S 34.20(c)(3) AUTOMATIC SECURING OF SOURCE ASSEMBLY Thirty-two comments were received on this requirement. Seven, or 22 percent of the commenters approved and twenty-five, or 78 percent were opposed. The principal comments were as follows: I 04/26/89 15 Enclosure D l i l I 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. 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. l OPPOSED Commenter 8 Thinks it will add to the complexity of the devices. 18 Will need'added maintenance and it is unclear tisat it would be cost effective. 19 Retrofitting will probably result in increased exposures. Models that already have this feature have failed, -- locking the source outside the device rather than inside. ) i Do not think it will improve safety. Tech-Ops model 900 which has 32 this option can be defeated by taping the locking knob in the upright position. 33 Could be a problem maintenance wise. Also personnel could by pass it if it caused aggravation. l Complicates exposure sequence, --- it also could be bypassed. 35 04/26/89 16 Enclosure D i !!o

• e

's. OPPOSED (Cont'd)- Commenter 38 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 radiographer to lock the projector and also the cranking device itself. Extremely negative response. Lack of maintenance or work in hostile 42 condition could cause problems. 43 Will need maintenance and will not be cost effective. Object to having to manually reset device after each shot. I 47 Will lessen dependence on surveys. Reduces' radiographer's use of survey meter. Also locking devices 49 that secure the control cable greatly increase cable wear. More parts can cause more malfunctions. Also could keep source out 64 of device. 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. 88 Could cause source to be locked out. Staff Fosition 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 04/26/89 17 o b2 ' require manual unlecking b2 fora the n xt exposure, something that should also..e required if present procedures are followed. The provision will remain I as' proposed. l S 34.20(c)(4) REQUIRE SAFETY PLUGS OR COVERS, l S l A total of sixteen comments were received on this requirement. All of them approved. There were only three substantive comments received, as follows: 1 Commenter l 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 co hold the covers or plugs and keep them clean. Taping them to the camera as has beer, practiced by some radiographer, results in a sticky residue which attracts grit which then works its w1y into the device when the covers are put in place and tends to cause internal wear of parts. 89 Equipment should be required to perform satisfactorily under adverse environmental conditions and it should be left to the manufacturer to determine how to achieve this. Staff Position General design conditions under Section 5.1 of ANSI N432 presently call for the exposure 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 moving parts. The staff feels that the requirements as stated will require users to use appropriate plugs or covers during storage or transportation. No change is to be made in this requirement. 04/26/89 18 i 1 -I b,. 'sj S 34.20(c)(5) LABELLING OF SOURCE OR SOURCE ASSEMBLY A total of twelve comments were received on this requirement. One was opposed and eleven approved. Only two substantive comments were received, as follows: l Commenter l 64 The requirement does not pose a problem if it doesn't intarfere with l the. lock or guide tube operation. However a durable tag that is 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 overexposure 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. Staff Response This requirement has been an effective part of the Texas radiation control regulations since October 1, 1987, and while there were a few problems ini-tially, these appear to have been solved. Initially heat shrinkable plastic j 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 $-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. 04/26/89 19 Enclosure D j I) S 34.20(c)(6) GUIDE TUBE CRUSHING TESTS AND KINKING RESISTANCE TEST A total' of ten comment letters were received on this requirement, eight approving and two opposed. The cnly substantive comments came from the aircraft maintenance ccmmunity and these are listed below: Commenter i The thin walled guide tubes used to inspect vane pins on aircraft 23 engines would not meet the kinking and crushing tests proposed. 67-There are occasions when other types of guide tubes are required, such as braided tubes or stainless steel. How does NRC suggest l handling these issues. from a regulatory viewpoint? Some of our guide tubes used in power plant turbines will not pass 88 this requirement. Staff 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-tion of the Final Rule. Persons who have special requirements may apply for an exemption under S 34.51. S 34.20(c)(7) REQUIREMENT TO USE GUIDE TUBES A total of three comments were received on this requirement. All were i approving. One question was raised and this is listed below: Commenter What is the implication of ~ conduits in this requirement? 18 l 04/26/89 20 Enclosure D 4 i I 2 Staff Responso In the American National Standard N432 under definitions is found the i following: SOURCE GUIDE TUDE (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 a.nd the word has no particular significance except to provide some added clarity. The word conduit has been ren.oved. S 34.20(c)(8) REQUIRE THE USE OF EXPOSURE HEADS A total of eight comments were received on this requiree nt. All were favorable. One commenter suggested combining this with the next requirement. Comme _nter 18 Why not designate all termittations designed to prevent emergence of the source from the guide tube as requiring a pull test d>en mar.ufactured? l Staff Response We think that this is what S 34.20(c)(9) actually says, No changes are to he made. i S 34.20(c)(9) REQUIRE A GUIDE TUBE TENSILE TEST l 'Only two comments were received on this requirement, both were in favor. l Staff Response No changes are anticipated for this requirement. 04/26/89 21 Enclosure D u__-___________-- i ~, 5 34.20(c)(10) SOURCE CHANGERS A total cf three comments were received on this requirement. The comments received were as follows:

Commenter 1

Requirements for source changers should be separated out from this paragraph--- more appropriately as a S 34.20(f). 8 o Source changer design is adequate. 88 e Most source changers leave something to be desired. Staff Response Since source changers fall within the category of essociated equipment, no need is seen for relocatii,g this provision. The words have been changed slightly to help make the intent of the provision more clear. S 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: I l APPROVED Commenter 76 Approves of the five year limitation here but requests two and one half years for compliance with S 34.20(d). 1 i l 04/26/89 22 Enclosure D s) l -{ q d OPPOSED 'I ~ 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. Feels that the government is trying to help industry sell more devices. l 4 The five year limit should be extended, to ten years. Seasonal work extends ths lifetime of devices as there is less use. 13 Use, work conditions, type of S tube etc. determine lifetime. Would prefer to see a periodic inspection by manufacturers to determine when to recall devices. Five years is.too short. Cobalt 60 devices are used much less than 15 those with Iridium and should have a longer life. Lifetime depends on type, use, and quality of the maintenance program. Repla:ement of devices with those complying with the rule should be determined by attrition. Lifetime is determined by how far the source has to be cranked 6ut 18 as well as by type of S tube and amount of dirt in work area. C.oul d consider revalidating equipment as required for Type B packages under Part 71 with manufacturers assessing the safety and need for replacement. 22 F

ires acuipment should have a ten year time frame to comply.

Five years is too short. Some devices have a life expectancy of ten 26 to fifteen years. Also replacement costs are high, ours would be $48,000. The five year grace period will cause a financial burden. Experience 27 has shown that properly maintained equipment will perform in excess of ten-twelve years. 04/26/89 23 Enclosure D (- ri 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, $637,500. This would not be a prudent use of funds. 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 is 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 have yet to be developed and tested. 75 Lifetime should be more like twelve years. Six out of seven devices j purchased in 1967 are still working fine at our company. i 77 Five years is unacceptably short. Equipment should be sent back to { the manufacturer or en approved service center for appropriate maintenance every two to three years. 82 There is only one type 1R device available at present and that is only for Iridium. There are no type IR devices for Cobolt 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 in its present form this j firm will probably have to discontinue business. 04/26/89 24 Enclosure D Y _ _ _ -_ _ _ - I 3, [. I (! opp 0 SED (Cont'd) Commenter fxperience has shown that properly maintained equipment een safely 83 last ten to twenty years. Our replacement costs would be 560,^00. 85 Our cost of. replacement would be $150,000. Staff Response 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 sma71er 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 that many of the devices now in use by the industry may be f rom 10 to 20 years old, ro longer in production, and replacement parts unavailable Emphasis of this point is shown by the intent of one of the larger device suppliers to issue a notice phasing 'out of service over a period of 3 years beginning in 1989, certain of the devices it norma 11y' services because of unavailability of replacement parts. The staff feels that many other devices 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 presumably, unsafe devices. While many of the commenters feel that this pro-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 compliance with the new rule would constitute a financial burden, it should be pointed out that all equipment in use at the time of publication of the prposed L 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 04/26/89 25 Enclosure D I 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 indicates that the cost to the l incustry resulting from implementation of this provision of the rule is of the 1 j, order of $4 million dollars on a 1989 present worth basis calculated over the l ten year interval from 1990 to 1999. The cost to the individual licensee resulting from implementation of this provision of the rule over the same ten l 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 arguments presented here the provision remains as proposed except that the five year period shall start from the effective date of the final rule. 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 We support the radiation levels of less than 200 mR/hr at the 18 j 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 Requiring all radiographic equipment to meet the levels specified in 21 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 expnsures to radiography personnel. 04/26/89 26 Enclosure D { s g. L OPPOSliD (Cont'd) Commenter l '86 We support the incorporation of ANSI N432.except for the condition of reduced exterior radiation levels specified for the following reasonsr l (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, the pursuit of ALARA and the necessity for compatibility with DOT and 150 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 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 52 percent were opposed. The only substantive comments were those received from persons opposed to the requirement and the principal comments were as follows: 04/26/89 27 Enclosure D I,, =. l Commenter Don't agree with this requirement. Think that reporting of defective 8 equipment should be reported under 10 CFR Part 21. Approve of the additional reporting requirements for the case of a 22 disconnect or of an overexposure. Feel that the cther items are normal maintenance problems that occur an an average of ten times per year. The cost of reporting the:;e is undere.',timated. We feel that reporting ten of these normal maintenance prablems 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 overexposure. 6 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 Re9orting equipment failures is difficult and impossible to enforce. Licensees will just not do it. 59 Agree that significant malfunction,s should be reported but that other component failures should merely be filed for NRC inspection and review. Feel that b 34.30(a)(3) is too all encompassing. Suggest that this 64 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 c'ata collection requirement only. 88 It tron't work. Some companies can only afford cheap equipment that is prone to more problems. They won't comply because they kr.]w that if they report honestly the equipment will be banned by the NRC. 04/26/89 28 Enclosure D n o ' Staff Responso The staff agrees that item three of these provision was amoiguous'and has rewritten it to apply only te components critical to safe operations. 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 o 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 the nuclear power industry. However, calibration or daily checks may be a problem. NRC requires a d.aily creck but does not 7pecify how it should be done -- NRC should specify the criteria for such checks. 30 Specify alarm rate meter instead of dosimeter. Also modern chirpers { should not be banned. f l 44 Believe in personal alarms for radiographer but should be able to ure 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 ) 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. { 1 04/26/89 29 Enclosure D - _ _ _ _ - - _ =.. _ - -. _ - - - - - - - - -. - - i l APPROVED (Cont'd) l l Commenter 64 Concur in their use. Don't like the 500 mR/hr alarm level. Also b should be aware that thEy can malfunction and read zero. 1 73 Feel that this requirement would do more tc protect radiographer than any equiprent design change. '79 We have used audible alarms for ters years and they have cut our overexposure to zero. OPPOSED Commenter. 2. Does not address problem. If radiographer cannot adequately monitor his survey meter then two man crews should bt required. 4

• ~

Don't need if proper surveys are made. Recommends two man crews for all field assignments. 7 e 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 use. Have mixed emotions --- in the past some empioyees used them and 13 6 became t60 dependent on the alarms. i Reliance on alarm dosimeters could lead to overexposure. I 15 22 ObjGct. Management and regulatory agencies need to enforce proper procedures instead. 04/26/89 30 Enclosure D l OPPOSED (Cont'd) Commenter 26 Will tend to reduce radiographer's use of the survey meters. 28 Will result in non performance of radiation surveys and may have a negative impact on safety. This proposed solution fails to address 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. 35 Is of negligible benefit---- just another piece of equioment that could lead to reduced use of survey meters. 38 Recommend that this requirement be dropped. Also maintenance and calibration could be costly, $7,800 initicily and $2,600 annually. k 40 Our strongest objections ere to this requirement. Feel that knowledge and experience of radiographer are the most important items. Request an exemption from this requirement for permanant i faellities. 1 45 Alerm dosimeters are big, bulky and heavy and can get dropped or damaged. Also radiographer may use them in place of a survey. i 48 Object, use of surveys will deteriorate. 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. 04/26/89 31 Enclosure D l 1 n.. (. s. OPPOSED (Cont'd) -Commenter. 59 e. Suggest an alarm on the survey meters in use. 69 -

• Will encourage radiographer to ignore the survey meter.

71 Alarm dosimeters.will promote complacency in the use of survey meters. Alarm dosimeters wil'1 add little to safety but greatly to users 81~.* 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 dose rates from devices are limited to 50 mR/hr at five cm. 83 Radiographer will rely on alarm dosimeters instead of the survey meter. Staff Response The staff does not agree with the assumption'that radiographer will neglect using survey meters. Alt,o survey meters with alarms do not supply the redundancy cf a separate alarm ratemeter since the alarm on the survey meter is

onnected 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 cost environments. The provision has been changed to exempt permanent facilities from this requirement since other alarming or warning devices are alreaQy required. S 34.33(f)(2) ALARM DOSIMETERS MUST ALARM AT A PRESET LEVEL OF 500 MR/HR Thirteen comments were received on this requirement. All thirteen, or 100 percent were opposed. No commenters approved. Principal comments were as follows: 04/26/89 32 Enclosure D t' 4 Commenttr This may require a check source large enough to require a specific l' ' license and could add considerably to-the cost impact of the rule. Believe that'this level is too high because it is too difficult to 18 test conveniently. Should specify an alarm rate meter instead of dosimeter. Believe 30 that the level is too high to test conveniently. l The licensee should be given adequate latitude to determine its cwn 39 alarm level. We don't want to use them at a permanent facility where there are 40 already adequate alarm systems. 44 It should not take a 500 mR/hr field to cause an alarm. The specified alarm level of 500 mR/hr is too high. 47 53 Feel that the recommended 500 mR/hr level is too high a rate to trigger an alarm for Air Force needs. The 500 mR/hr set point would be inadequate around power facilities. 56 Suggest allowing the ciarn setting to be at 100-200 mR/hr aboy? bac.kground. Question the need for a daily response test in a 500 mR/hr field. 60 Do not agree that the alarm trigger be confined to 500 mR/hr dose 64 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. Commenter does not want his workers working in a 500 mR/hr environment. 82 04/26/89 33 l o s Commenter 88 Alarm dosimettrs are a good idea but the 500 mR/hr dose rate is too high. 1 1 STAFF POSITION Calculations for a 200 Ci Iridium source at a normal operator position (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 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 exetaption 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-E tronic check point. Calibration requirements have been changed to require them on ar annual basis instead. No other changes have been made. l ASNT SURVEY The ASNT Survey which was discussed briefly on page 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 j survey does not track the proposed rule and it is difficult to assess. On the surface it appears that the respondents have a favorable outlook on all aspects of the proposed rule but this conclusien is at odds with the results of people who providad direct comments on the rule. 1 i 1 1 04/26/89 34 ~e The American Society for Nondestructive Testing, Inc. Member Survey Regarding: Proposed Safety. Requirements 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 LATER 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 Yotal Respondents 399 1. Are you currently or have you previcusly been a user of industrici radio 0raphy equipment? 0.995 Yes 0.005 No 04/26/89 35 Enclosure D l .s

• a Meao 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 Gcmma 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 metion 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. 9.90 Agree 0.05 Disagree 0.04 No Opinion 5. The exposure device shall be equipped with a visual indicator that indicates when the source assembly is in the fully shielded position and the shutter (if any) is closed. 0.60 Agr?e 0,35 Disagree 0.05 No Opinion l 6. An exposure head or similar device, designed to prevent the sourr.e j astembly five passing out the end of the guide tube, shall be attached to I-the outermest end of the guide ts.be. 0.86 Agree' O.11 Disagraa 0.04 No Opinion I 04/26/89 36 Enclosure D 1 A I o Memo to Members 1. l 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. 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 reduced to the levels specified in ANSI N432. For portable devices the limits are 200 mR/Hr @ surface or 50 mR/hr 9 50mm and 2 mR/hr @ 1 meter. For mobile devices the limits are 200 mR/Hr @ surface of 100 mR/Hr @ 50 mm and 5 mR/hr @ 1 meter. 0.71 Agree 0.19 Disagree 0.10 No Opinion 30. If the licensee receives a devica later than one year after the effective date of the final ruie, 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 Nc Gpinion 13. All radiographic exposure devices not in compliar,ce shall be withdrawn 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 04/26/89 37 Enclosure D t E

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0 . Memo to Members 12. Each radiographer and assistant shall wear an alarm dosimeter. 0.61 Agree 0.35 Disagree 0.03 No Opinion l-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 1 04/26/89 38 5.... ,A? . 2.y,; ~ y t : c, Dbcument'Name:... ' ~ ~ COMMENTS / ANALYSIS FINAL RULE- ~ - Requestor's-ID: -MENDIOLA : - Author's Name: ~ DNellis Docuinent *omments: u . Part of a final rule package. 4 0 e- e ~ I' L I' CONGRESSIONAL LETTER l Enclosed for the information of the Subcommittee.is a copy of a final rule amending 10 CFR Part 34 that will be published in the Federal Register. The Nuclear Regulatory Commission is amending its regulations with respect to those licensees ~ngaged in industrial radiography. This amendment will' e require that radiographic exposure devices meet specified performance standards and will require that radiographer wear alarm rateraeters to provic't supplemental warning of unsuspected unshielded radioactive sources. The amendment is expected to help reduce the incidence of serious radiation exposures to radiographer and members of the general public. The Commission is issuing the final rule with an effective date 1 year after publication in the Federal Register. Enclosure E jg :. w I PUBLIC ANNOUNCEMENT NRC_ AMENDS ITS REGULATION ON I SAFETY REQUIREttENTS FOR INDUSTRIAL RADIOGRAPHIC EXPOSURE EQUIPMENT The Nuclear Regulatory Coniiission is amending its regulations dealing with l industrial radiographic equipment to establish new regulatory requirements in l the form of performance standards for such equipment. -A requirement for radiographer to wear alarm ratemeters is also included. The incidence of radiation overexposure of radiographer occurs at a rate that is double that of radiation workers in other fields. This, coupled with'the potential for overexposure to the general public from the high intensity radioactive sources used in the radiography industry, has been a matter of concern to the NRC for some' time. Most of the industrial radiography overexposure are the result of inadvertently allowing the radioactive source to remuin out of its shielded position in the exposure device because of improper operational procedures or equipment malfunction. This amendment is intended to reduce equipment I malfunction and will require a supplemental warning device for radiographer to alert them to the presence of an unshielded radioactive source, whether I caused by improper procedures or equipment malfunction. Enclosure F l } j f (F .qo o DAMSMITTE T0-Document Control Desk! 016 Phillips .fj ADVANCED COPY TO: The Public Document Room 7/ '/79 N# 9 3 DATE: ij FROM: SECY Correspondence & Records Branch 1 Attached are copies of a Commission meeting transcript and related meeting l' document (s). They are being forwarded for entry on the Daily Accession List and placement in the Public Document Room. No other distribution is requested or l required. I Meeting

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