ML20138F078

Requests Commission Approval of Final Rule & Associated Rev to Enforcement Policy

ML20138F078
Person / Time
Issue date:	07/03/1996
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
FRN-62FR28948 AE07-2-018, AE7-2, AE7-2-16, AE7-2-17, AE7-2-18, SECY-96-152, SECY-96-152-R, NUDOCS 9607110325
Download: ML20138F078 (204)

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' n e n . . . . . . . . . initials RULEMAKING ISSUE July 3, 1996 (Affirmation)

SECY-96-152 FOR: The Commissioners l FROM: James M. Taylor, Executive Director for Operations

SUBJECT:

FINAL RULEMAKING - REVISION TO 10 CFR PART 34, LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS AND REVISION TO THE NRC ENFORCEMENT POLICY PURPOSE:

To obtain Commission approval of the final rule and the associated revision to the enforcement policy.

SUMMARY

The attached final rulemaking package incorporates a number of changes to 10 CFR Part 34 that have been underway for several years. The primary changes i involve requirements for: 1) use of two qualified individuals whenever radiographic operations occur outside a permanent facility; 2) mandatory certification of radiographers; 3) a radiation safety officer; and

4) additional training for radiographers' assistants. These changes were originally proposed to make NRC regulations more compatible with the Agreement States that have already upgraded industrial radiography requirements. There may be some cost associated with these new requirements, but most will be offset by burden reductions in the final rule on the frequency of field inspections conducted by licensees to evaluate radiographer performance. The requirement for two-person crews may result in some cost for those licensees not already using two-person crews, but the staff's analysis shows that for the majority of licensees, the rule will result in a cost savings.

CONTACT:

Cheryl Trottier, RES 415-6232 James Lieberman, OE i

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BACKGROUND:

The staff was directed by a Staff Requirements Memorandum, dated April 25, 1991, to prepare a proposed rule revising certain portions of 10 CFR Part 34 to make it more consistent with the approaches taken by the Agreement States in the " Suggested State Regulations for Control of Radiation." The industrial radiography safety concepts embodied in this revision evolved during a 5-year l collaborative process involving NRC staff, the Agreement States, American Society for Non-Destructive Testing (ASNT), radiography equipment manufacturers, radiography licensees, radiographars and industry. In developing the proposed rulemaking, the staff solicited recommendations on radiography issues from the Agreement States at the All-Agreement States meeting in October 1991, and from NRC Regional Offices, radiography equipment manufacturers, and radiography licensees. Also, a workshop was held on November 18, 1992, in Dallas, Texas, to discuss the recommendations received from the Agreement States and licensees. The staff held separate discussions with the Agreement States and members of the public on mandatory radiographer certification at the May 1991 Conference of Radiation Control Program Directors (CRCPD), Annual Meeting in Wichita, Kansas, and at a workshop on May 27-28, 1992, in Mobile, Alabama. The proposed rule also addressed a petition for rulemaking filed by the International Union of Operating Engineers (IU0E), Local No. 2, in October 1992, that requested revision of 10 CFR Part 34 that would require a minimum of two radiographic personnel when performing operations with radioactive material at temporary Jobsites.

The proposed rule addressed five major changes to the present regulations.

The first proposed change would require a minimum of two individuals to be l

present any time radiographic operations occur outside of a permanent l

radiographic installation. The second proposed change would require mandatory third party certification for radiographers. The third proposed change, in 10 CFR Part 34, involved identifying specific requirements related to the qualifications and duties of a radiation safety officer. The fourth proposed change would upgrade the training requirements for radiographer's assistants l and the last major change was to revise the definition of a permanent l radiographic installation to remove the ambiguities regarding its purpose.

By a Staff Requirements Memorandum, dated January 7, 1994, the Commission approved publication of proposed revisions to 10 CFR Part 34. The proposed rule was published for comment on February 28, 1994 (59 FR 9429), for a period of 90 days.

l l DISCUSSION:

Fifty-eight comment letters, representing approximately 31 percent of the NRC licensees and 21 percent of the Agreement States, were received in response to the Federal Register notice on the proposed rule. The staff held a workshop on December 13-15, 1994, in Houston, Texas with the Agreement States and the public to discuss the major issues identified during the resolution of comments. Five additional comment letters were received after this workshop, two from NRC licensees and three from Agreement States. Subsequent to the workshop, the staff re-evaluated the impact of the two proposed changes to the

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regulations that would impose the greatest cost to the NRC licensees: the requirement for a minimum of two individuals to always be present whenever radiography is performed at a temporary jobsite, and the requirement for mandatory certification of radiographers.

The most expensive change considered in the proposed rule, was the obligation to have at least two radiographers or one radiographer plus one other individual who, as a minimum, has met the training requirements of a radiographer's assistant to be present any time radiographic operations occur outside of a permanent radiographic installation. A major factor cited by industry as a reason for adopting the two-person requirement is that it would level the playing field for all radiography licensees, in that it would prevent competing radiography firms from underbidding radiography work based solely on the use of a one-person crew. Commenters supporting the proposed two-person provision stated that the cost to hire additional workers would not really impact them because they would simply pass this cost on to their customers. Although 77 percent of the comments received on this requirement favored adoption of the requirement as proposed, some comments (primarily from j small licensees) opposed this requirement. These commenter2 expressed concerns about the financial impact of this requirement on their operations.

l A frequently raised comment in support of the two-person crew questioned the effectiveness of one individual in providing surveillance of radiographic operations. The current NRC regulations already require licensees to maintain I adequate surveillance of the restricted area during radiographic operations to prevent the public from inadvertently entering the restricted area. Most NRC l licensees already use more than one individual to comply with the existing '

requirement. One advantage cited by commenters of requiring a minimum of two qualified individuals is to provide redundancy. For example, in the event a malfunction occurs causing the source to not be in a shielded position, two individuals may be better at solving the problem than one. I 1

At a meeting with members of the radiography industry in March 1995, the staff l stated that several of the major provisions of the proposed rule might not be '

recommended for adoption in order to reduce the implementation cost of the final rule. This staff position was also provided to Agreement States ,

representatives during the April 1995 workshop for Agreement States program )

managers. Subsequent to these meetings, 26 additional letters were received, l including letters from 11 of the Agreement States. The Agreement States and the industry representatives wno responded expressed dissatisfaction that the NRC might consider finalizing the revisions to 10 CFR Part 34 without two key requirements: the two-person requirement and mandatory certification of radiographers.

The 11 Agreement States submitting letters after the April 1995, workshop stated that a number of changes (radiographer certification, improved equipment standards and two-person crews) are needed to produce the best assurance for the protection of public health and safety and believe that NRC's decision not to include a requirement for two-person industrial radiography crews in this rulemaking provides a lesser degree of safety than the regulatory approach being followed by the Agreement States. Additionally, i

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these Agreement States expressed a view that the NRC was disregarding the collective regulatory experience of the Agreement States and the safety experience of the industry, and by not adopting the two-person requirement, '

inconsistency among regulatory programs will continue.

A recurrent theme, expressed by the Agreement States, was that this NRC position could undermine the progress of recent years in developing rules l through a participatory process. A view expressed by some of the Agreement States was that failure on the part of the NRC to adopt the two-person provision in the final rule could pose a hardship on NRC licensees working under reciprocity in those Agreement States requiring two-person crews. These  ;

Agreement States indicated that NRC licensees wishing to work under reciprocity in these States would be expected to use two-person crews.

Currently, .18 of the 29 Agreement States have adopted a requirement for a minimum of two qualified individuals to perform radiography at temporary jobsites. Several of these States (Illinois and Texas) currently have requirements more stringent than those proposed by NRC, in that they require both individuals to be certified radiogrephers.

l In a memorandum, dated March 18, 1996, the staff requested Commission guidance l on whether to include the two-person provision in the final rule package. In ,

i COMSECY-96-006, the Commission approved the staff's proposal to include the l two-person requirement in the final rule, provided the cost-benefit analysis l supports such an inclusion.

l l The final rule does include the requirement that at least, two qualified l individuals, a radiographer and a radiographer's assistant, be present l whenever radiographic operations occur outside a permanent installation. The i staff is recommending adoption of this provision on the basis that while there l will be some additional cost for a few licensees, the benefit of having two l individuals always present will justify the additional cost. Although the t staff believes that adopting the requirement to always use at least two l individuals at temporary jobsites could force a few licensees out of the l radiography business, NRC licensees working in many Agreement States are l already using two-person crews, and adoption of this provision would result in a uniform National standard. The enclosed regulatory analysis (Enclosure 3) indicates that the implementation cost for each of the 30-60 affected licensees would be between $24,000 and $72,000 per year, with a 10-year operating and maintenance cost between $168,480 and $505,440 per licensee for the two-person provision. The range used in the analysis assumes that only l these 30-60 NRC licensees would need to hire any assistants and that these licensees would hire 1-3 assistants.

The primary benefit will be an increase in assurance that operational safety measures will be implemented effectively and if an incapacitating injury to the radiographer should occur, the second individual could possibly prevent unnecessary radiation exposures to the worker and the public. In addition, adoption of a consistent National standard will level the field for those licensees that to enhance safety currently elect to use two individuals. If the Commission chooses to not adopt the provision that at least two qualified s

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i i The Commissioners 5 individuals be present when radiographic operations are undertaken outside of a permanent installation, the Commission would deny the petition from the IU0E. This final rule completes NRC action in response to the petition.

The second major issue in the proposed rule addressed mandatory certification for radiographers. Some of the larger licensee organizations objected to the requirement because they believed their in-house training programs were

! adequate and could see no need to rely on an outside organization to certify the training of their radiographers. Twelve of the Agreement States strongly supported the NRC adopting mandatory certification and stated that, along with other upgrades discussed earlier that have been adopted by a number of l Agreement States, they have seen an overall improvement in safety awareness l with their adoption of the mandatory certification requirement for

! radiographers. The majority of letters favoring adoption of mandatory certification were from the Agreement States.

The staff is proposing to adopt the provisions for mandatory certification, primarily in light of the positive results observed by the Agreement States and because it provides a consistent standard for measuring the training of

, all radiographers and will reduce the burden on licensees in confirming the I

training status of newly hired radiographers. For those licensees that objected to adoption of this provision because they already have a strong l

training program, the burden to follow a uniform testing program should be minimal. As discussed in the attached Regulatory Analysis, the cost to certify an individual radiographer is not great.

The final rule will require radiographers to become certified 2 years after the effective date of the rule. Present compatibility procedures require

Agreement State adoption of this requirement no later than 3 years after the effective date of the rule for NRC licensees. Given the above time constraints, it may take 5 years from the effective date of the rule before l national radiographer certification is fully achieved. Assuming the NRC's rule is effective in 1996, this may create a situation where there are l differing certification requirements in the Agreement States until the year

! 2001. The staff believes, however, that this is a minor matter because approximately eight Agreement States have certification requirements already l

in place and two more have adopted such a requirement but have yet to implement it. Most of the States where this requirement is in place also have l the largest populations of industrial radiography licensees, e.g., Texas and l Louisiana.

A collateral issue related to radiographer certification where the staff is continuing to work with the Agreement States, the Organization of Agreement States (0AS), CRCPD, ASNT, and the regulated community involves development of i a national certification program. It is anticipated that as this program evolves, the staff will develop a machanism to exchange information about the certification status of individual radiographers. This will enable licensees and regulators to take prompt action to prevent a poor performer whose certification has been revoked from simply moving to another State with an invalid card. This issue will continue to be discussed among the participants i

l The Commissioners 6 to complete the administrative framework required to support a national certification program.

A third major modification in the proposed rule involved requirements for a l Radiation Safety Officer-(RS0) and was adopted from the Texas regulations.  !

l The final rule specifies the qualifications and duties of the RSO. The RS0 is I the key licensee individual charged with the responsibility to ensure that the requirements in the license are followed. By listing the specific duties of l the RS0, and requiring additional training for this position, this individual l should be qualified to provide the appropriate attention to radiation safety l under the employ of the licensee.  !

A number of commenters were in favor of adopting this requirement. Those opposed were primarily against the qualification requirement that only an l individual who had 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> of documented experience as a radiographer would '

! be qualified to be an RSO. This requirement was an issue for some licensees I

who have a variety of licensed activities for the RS0 to oversee and where the use of a radiographer for this purpose would not be appropriate. To address these concerns an additional paragraph 34.42(b) was added stating that the Commission will consider alternatives to the qualifications listed under l 5 34.43(a) when the individual has the appropriate training and experience.

1 The last two major modifications included in the proposed rule: increased l training for radiographer's assistants and a revised definition for permanent radiographic installations, received only a few comments involving some l

clarification of terms and minor editorial changes. These have remained l essentially as originally proposed. Although not originally identified as major modifications, several provisions of the proposed rule would actually result in burden reduction to licensees, i.e., by reducing the frequency of survey meter calibrations and the frequency of licensee inspections of I radiographer performance.

Several Agreement States have raised a concern that the additional training

. received by the radiographer's assistant is still not sufficient. In l particular, these Agreement States require the radiographer's assistant to receive training in radiation safety subjects that are identified in 5 34.43(g). Several States use the term trainee, rather than radiographer's assistant, because they also expect them to become certified radiographers within a set period of time. This requirement has not been adopted in 10 CFR Part 34. A number of licensees at the Houston, Texas, workshop stated that they would find it a burden to upgrade all radiographer's assistants to the status of radiographer. Because these regulations are primarily a Division 2 level of compatibility, the Agreement States are not prohibited from requiring l

the additional training for radiographer's assistants, or from establishing a i separate category, using the term " trainee," in place of radiographer's assistant.

The consensus of the Agreement States, expressed at the December 1994, Houston, Texas, workshop was that one provision in the current rule provided little, if any, safety benefit. This provision requires the use of alarming ratemeters to alert the wearer of high radiation. The Agreement State l

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O t The Commissioners 7 representatives stated that in many situations they may actually contribute to incidents due to their misuse as a survey instrument. In addition, the Agreement States questioned the statistics on reductions in overexposures the NRC has used to justify the continued use of alarming ratemeters. The staff strongly supports maintaining this requirement in the final rule because the evidence (fewer overexposures since the rule was promulgated) supports its continuance. The staff believes it is unlikely that dropping the requirement for the alarming ratemeter would have any beneficial effect on whether the appropriate surveys are completed.

While the staff was preparing the final rule, a number of licensees contacted the NRC requesting clarification of what radiography equipment components would need to comply with the performance requirements in 5 34.20. In 1991, the radiography equipment requirements were revised and licensees were given until January 1996, to comply. In response to these requests, IN-95-58 was issued on December 18, 1995, reminding licensees of the January 10, 1996, effective date and informing them which components met the new requirements.

After the Information Notice (IN) was issued, subsequent communications from licensees and manufacturers indicated that many components in use and not listed in the IN had not been subjected to prototype testing or an engineering analysis. Another IN was issued, on April 4, 1996, to provide licensees with information on acceptable means for demonstrating the acceptability of associated equipment in use. These circumstances demonstrate that the current requirements for radiography equipment may need re-evaluation. The staff will begin a review of the current equipment requirements promulgated in 1991, to i determine the minimum set required and whether a better approach would be to I use a performance stan6ard in place of the ANSI standard in the existing regulation. The FRN for this rulemaking incluaes a statement addressing this ,

isshe. l As a result of the revision to 10 CFR Part 34, amendments are needed to the Enforcement Policy. The proposed revisions are described in the enclosed Federal Register notice. The revision would be effective concurrently with the amendments to 10 CFR Part 34. They will also be reflected in the next revision to NUREG-1600.

RESOURCES:

Resources required to implement these amendments are included in the NRC Five-Year Plan. This rule should have no significant impact on NRC's industrial radiography licensing and inspection programs. While NRC's radiography licensees would be expected to revise their procedures to implement the revised or new requirements within 60 days, licensees would be permitted to

! wait until their next renewal to submit the revised procedures to the NRC for i review, which may be up to 10 years in some cases, due to the recent one-time extension on materials license renewals. In the interim, NRC inspection staff would confirm, as part of its regular inspection activity, that licensees had implemented the revised regulatory requirements. There may be a slight increase in time required to conduct license reviews and inspections; however,

O e The Commissioners 8 the staff believes that the resources required should be minor and can be accounted for within existing resource allocations.

C0 ORDINATION: The Office of the General Counsel has no legal objection to this paper.

RECOMMENDATION:

That the Commission:

1. Approve the Nr- .e of Final Rulemaking and Revision to the NRC Enforcement Poiicy for publication (Enclosures 1 and 2).

2. Note:

a. That a final Regulatory Analysis will be available in the Public Document T(om (Enclosure 3);

b. The staff has prepared an environmental assessment (Enclosure 4).

The assessment concludes that the action will not significantly affect the quality of the human environment;

c. That in accordance with the Regulatory Flexibility Act, an init.al regulatory flexibility analysis has been prepared. The analysis indicates that this rule will not have a major adverse economic impact on radiography licensees, and, in fact, there should be an overall cost savings to all licensees based on reductions in existing regulations that offset any additional costs.

Approximately 90 percent of these licensees are considered to be "small entities." The estimated costs are not considered to be overly burdensome in light of the resultant benefits derived.

d. That the final rule contains information collection requirements that are subject to review by OMB. Upon Commission approval, formal request for 0MB review and clearance will be initiated;

e. That the Agreement States have been provided with a copy of the final rule and their comments have been considered in developing the final rule;

f. A public announcement will be issued (Enclosure 5);

g. The appropriate Congressional committees will be informed (Enclosure 6);

h. The staff has determined that, under the Small Business Regulatory Enforcement Fairness Act of 1996, this is not a " major rule" because although it may effect some small businesses, the majority of licensees already voluntarily use two-persons or must do so to meet Agreement State regulations. The appropriate letters have been prepared (Enclosure 7); and

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i. Copies of the Federal Register notice of final rulemaking will be distributed to all 10 CFR Part 34 licensees. The notice will be sent to other interested parties upon request.

a es M. Tefl or i ecutive Director

! for Operations l

Enclosures:

As stated (7)

Commissioners' comments or consent should be provided directly to SECY by

( COB Friday, July 19, 1996. Commission staff office comments, if any, should be submitted to the Commissioners NLT July 12, 1996, with an information copy l to SECY. If the paper is of such a nature that it requires additional review i and comment, the Commissioners and the Secretariat should be apprised of when l comments may be expected.

l l This paper is tentatively scheduled for affirmation at an open meeting during l the week of July 29, 1996. Please refer to the appropriate weekly Commission schedule, when published, for a specific date and time.

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ENCLOSURE 1

i. FEDERAL REG STER NOTICE d

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NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30, 34, 71 and 150 RIN 3150-AE07 Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY

The Nuclear Regulatory Commission (NRC) is amending its regulations governing industrial radiography. This final rule updates radiation safety requirements in order to enhance the level of protection of radiographers and the public. By a separate action published today in the Federal Register, the Commission has issued a modification to the Enforcement Policy that reflects these amendments to 10 CFR Part 34.

EFFECTIVE DATE: (30 days after publication in the Federal Register)

FOR FURTHER INFORMATION CONTACT: Dr. Donald O. Nellis or Mary L. Thomas, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington DC 20555; Telephone: (301) 415-6257 or 415-6230.

SUPPLEMENTARY INFORMATION:

I. Background. .

II.

Final Rule Provisions and Response to Public Comments on the Proposed Rule.

III. Conforming Rule Changes.

IV. Agreement State Compatibility.

V. Implementation.

VI. Finding of No Significant Environmental Impact: Availability.

VII. Paperwork Reduction Act Statement.

VIII. Regulatory Analysis.

IX. Regulatory Flexibility Analysis.

X. Backfit Analysis.

I. Background Part 34 of Title 10 of the Code of Federal Regulations was first published in 1965 (30 FR 8185; June 26, 1965) during the recodification of existing 10 CFR Parts 30 and 31. Part 34 established a new part devoted specifically to regulating the safe use of sealed sources of byproduct material in industrial radiography. Numerous modifications made by a number of Agreement States to corresponding regulations led to a decision, in 1991, to develop an overall revision to 10 CFR Part 34. Subsequently, the NRC published a proposed rule on February 28, 1994 (59 FR 9429), that incorporated a number of recommendations made at meetings with the Agreement States and industry in 1991 and 1992. The NRC also reviewed the radiography regulations from Texas, Louisiana, Canada, and the " Suggested State Regulations for 2

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1 Control of Radiation," developed by the Conference of Radiation Control Program Directors (CRCPD), Inc., in developing the proposed regulation. .

The proposed rule also addressed the potential resolution of a petition from the International Union of Operating Engineers (IV0E), Local No. 2, requesting an amendment to the radiography regulations to require the presence of a minimum of two radiographic personnel when performing industrial radiography.at temporary jobsites.(PRM-34-4). Based on comments received on this petition (35 out of 38 comments) in favor of a two person requirement, the proposed revision to 10 CFR Part 34 included a provision for at least two qualified individuals to be present anytime radiographic operations are

undertaken outside a permanent installation.

The other major provisions of the proposed rule were to: (1) require mandatory certification of radiographers, (2) specify the qualifications and i

duties for a radiation safety officer, (3) include additional training I requirements for radiographers' assistants, and (4) clarify the definition of l

! a permanent radiographie installation. The proposed rule also revised the I format of 10 CFR Part 34 to place requirements into categories that more accurately describe the requirements found in the rule.

4 II. Response to Public Comments on the Proposed Rule

and Final Rule Provisions 4

The comment period on the proposed rule closed May 31, 1994, but the NRC continued to receive comments while developing the final rule. By mid-December 1994, a total of 58 public comment letters were received on the proposed rule. Many commenters expressed opinions and recomendations on j 3

several sections of the proposed rule while others commented on only a single section. In developing a final rule, the NRC held a workshop in Houston, .

Texas, on December 13-15, 1994, to discuss the resolution of public comments received up to that date on the proposed rule. In addition, the NRC discussed its views and ought comments on several of the key provisions of the proposed rule at an industry workshop held in Las Vegas, Nevada, on March 20, 1995, and the April 1995 workshop for Agreement State program managers. The transcripts of these meetings, which are available for inspection and copying in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington DC, were reviewed in developing the final rule. Following these workshops, an additional 31 comment letters were received, bringing the total to o9 public comment letters.

This final rule includes a partial granting of the petition, PRM-34-4, in that it requires, at a minimum, a two-person crew whenever radiographic operations are being conducted outside of a permanent radiographic installation. The NRC has decided not to adopt the term " radiographer trainee," (which was one of the options proposed in the petition) but is requiring instead that the second person be another qualified radiographer or an individual who has met, at a minimum, the requirements for a radiographer's assistant. The NRC recognizes that, in Agreement States, the training of those individuals designated as trali.3es would meet and generally exceed the NRC's training requirements for a radiographer's assistant. Trainees are required to successfully complete the 40-hour course on the subjects listed in 5 34.43(g), while a radiographer's assistant has to meet only those requirements in 5 34.43(c) and is not required to complete the 40-hour course described.

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The estimated cost of requiring the two-person-crew could be significant for licensees who currently send only one radiographer to a temporary jobsite. .

However, the current regulation requires direct surveillance of the operation to prevent unauthorized entry into a high radiation area. To comply with this regulation, most licensees already must use more than one qualified individual in many situations.

In summary, the Commission believes that by requiring at least two

qualified iniividuals to always be present when radiographic-operations are being conducted, there will be a significant increase in assurance that operational safety measures and emergency procedures will be effectively implemented. The expectation is that violations involving failures to perform adequate radiation surveys of radiographic exposure devices and the surrounding area, failures to adequately post and monitor the restricted area, and failures to lock and secure the camera when not in use will become less frequent. Louisiana and Texas adopted two-person crews several years ago and report a significant reduction in incidents and exposures. Many of the other

[ Agreement States have since adopted the requirement because of the implicit

_ safety benefit implied in having two persons available to cope with emergency f situations. Furthermore, if an incapacitating injury to a radiographer should occur at a remote location, the presence of a second individual could be an L important factor in preventing unnecessary radiation exposures. The i

l- Commission is amending the Enforcement Policy as a result of this final

. rulemaking to provide, as an example of a Severity Level III violation, the conduct of radiography operations without the required second radiographer or I individual with, at least, the qualifications of a radiographer's assistant as l provided in 5 34.41.

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The remaining issues addressed in the comments received on the proposed rule and the NRC responses to those comments are discussed under the -

applicable CFR section.

l l Section 34.1: Purpose and Scope.

l This section of the final rule is basically unchanged from the existing regulation, with the exception of minor clarifyine changes. Other NRC regulations, such as, Parts 19, 20, 21, 30, 71, 150, 170, and 171, that apply l

to radiography licensees are now referenced by number in this section, and

" radiography" is changed to " industrial radiography" to distinguish it from medical uses. No comments were received on this section.

l Section 34.3: Definitions.

This section provides definitions for terms used in this part. The l proposed rule included a number of new definitions, as well as proposed revisions to a number of existing definitions.

The proposed rule contained definitions for the following new terms not previously addressed in 10 CFR Part 34: ALARA, Annual safety review, Associated equipment, Becquerel, Certifying entity, Collimator, Control tube, Exposure head, Field examination, Field station, Gray, Independent certifying organization, Projection sheath, Radiation safety officer, Radiographer ce-tification, Radiographic operations, S-tube, Shielded position, Sievert, Source assembly, and Temporary jobsite.

The term ALARA (as low as is reasonably achievable) was added to describe l a key element of the revised standards for protection against radiation in

, 10 CFR Part 20. The terms Becquerel, Gray, and Sievert were added to define 1

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the metric units used in all new or revised regulations. The term Annual safety review was added to clarify what was meant by the term periodic .

training used previously in i 34.11.

The terms Certifying entity, Independent certifying organization, and Radiographer certification were added to describe terms associated with the proposed requirements for verification of radiographer training.

The terms Collimator and S-tube were added to describe pieces of equipment that are used in conducting radiographic operations. The terms Field station and Temporary jobsite were added to clarify the meaning of these commonly used terms.

The term Radiation safety officer was added to define the role of this individual in industrial radiography. The terms Associated equipment, Control tube, Exposure head, Practical examination, Projection sheath, and Source assembly were added because, while used in the regulation, they were not previously defined.

The proposed rule presented modifications to the definitions of Permanent radiographic installation, Storage area, and Storage container. The definition of Permanent radiographic installation was modified to remove ambiguities in the existing definition concerning what the phrase, " intended for radiography," meant.

The definitions of Storage area and Storage container were modified to remove references to transportation.

Comment.

The six comment letters that addressed this section requested several additions, clarifications, and changes to the proposed and existing definitions.

One commenter requested adding a section addressing the unique aspects of underwater, offshore platform, and lay-barge radiography. Another commenter requested defining the term " control drive mechanism" because it is l

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l used in the definition of control tube. Clarification of the meaning of the terms " annual safety review," " field examination," and " radiographer's .

assistant" was requested. One Agreement State (Illinois) requested that the definition of permanent radiographic installation not be changed as proposed, that the definition of radiographer certification be broadened to included authorization by an Agreement State, that the Commission adopt the term radiographer trainee, and the term working position be explained. They further requested that definitions of malfunction, defect, transport, and transport container be added and suggested a number of editorial changes to the definitions to make them similar to definitions-in the Suggested State Regulations used by many of the Agreement States.

Response.

In response to public comments, the NRC has added five new definitions to the final rule: Control cable, Control drive mechanism, Lay-barge radiography, Offshore platform radiography, and Underwater radiography. Some l

of the definitions in the proposed rule were changed in response to comments.

Annual safety review was changed to Annual refresher safety training to clarify that its purpose is training. Projection sheath was changed to the more commonly used term, Guide tube, and Beam limiter was changed back to its original term, Collimator. The term working position as used in the definition of Exposure head means the location of the equipment during operation. Radiography was changed to Industrial radiography to reduce any confusion with medical uses. Field examination was changed to Practical examination to clarify that it need not occur in the field. In response to a

! comment raised on 5 34.43, Training, a definition for hands-on experience was 8 <

cv added to the final rule. The other new definitions in the proposed rule are adopted in the final rule without change. .

Definitions for defect and malfunction, which are defined in 10 CFR Part 21 were not added to 10 CFR Part 34 to avoid the potential for confusion should 10 CFR Part 21 be revised without any subsequent revision to 10 CFR Part 34, and as a result these terms were to be defined differently in Parts 34 and 21. The definition of Radiographer certification already includes individuals certified by certifying entities (i.e., Agreement States) and therefore no change was made to the final rule. No definition was added for transport or transport container, although the Agreement States are free i

to adopt or use definitions for these terms.

Changing the definition of Radiographer's assistant was discussed at the November 1992 workshop in Dallas, Texas. Some Agreement States use the term

" trainee" to refer to a radiographer's assistant and also require training in the subjects in 5 34.43(g). NRC only requires this training for radiographers. Although the NRC is not adopting the term trainee or requiring radiographers' assistants to have the same training as radiographers, the Agreement States are not prohibited from using the term in.their requirements or from requiring the additional training.

Section 34.5: Interpretations.

This section, while not in 10 CFR Part 34 previously, was added to the proposed rule because this is standard regulatory language used to state that only the General Counsel of the NRC has the authority to provide interpretations of the regulations which will be binding on the Commission.

No comments were received on this section.

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Section 34.8: Information collection reauirements: OMB approval.

This section was basically unchanged in the proposed rule, except for .

changing the section numbers to conform to the new format of the proposed rule and to list any new requirements that require OMB approval. No comments were received on this section.

Section 34.13: Specific license for industrial radiography.

This section (previously 5 34.11), provides the basic requirements for submittal of a license application which must be met satisfactorily before NRC will approve the application. A number of changes to this section were proposed, including a reduction in the inspection frequency of job performance for radiographers and assistants, a requirement for submitting procedures for verifying and documenting the certification status of radiographers, a requirement to designate and identify a Radiation Safety Officer (RS0) responsible for the licensee's radiation safety program, provisions for leak testing for depleted uranium leakage on those radiographic exposure devices that u:e depleted uranium for shielding, and a requirement to provide the location and description of all field stations and permanent radiographic installations.

The requirement for conducting field inspections of job performance of radiographers and assistants was moved to 5 34.43 to more accurately reflect l 1

its role in the training program. In addition, a requirement for conducting  ;

annual refresher safety training was substituted for the previously used term of periodic training. These changes are described more fully under the discussion of 5 34.43.

10

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! The requirement to conduct tests to identify depleted uranium (DU) contamination was added to detect wear through the "S" tube into the DU .

shielding. Such a condition could cause bindi19 of the control cable in the l groove and possibly prevent the radiographer from retracting the source. A <

new requirement was proposed to identify procedures for conducting leak tests l for sealed sources and radiographic exposure devices containi19 (DU) shielding l

if the licensee intends to perform the leak testing. 1 Comment.

Nine comment letters addressed this section. Six opposed changing the frequency of required licensee inspections of radiographers and radiographers' assistants from quarterly to annually. They stated that there is great benefit in conducting quarterly inspections and recommended keeping the quarterly requirement. Three commented favorably on the requirement to designate and identify an RS0 (5 34.13(g)). One commenter suggested that the l

RS0 should only be responsible for ensuring that a radiation safety program was implemented rather than being the one who must implement it as the proposed rule had suggested.

Response.

Although some commenters suggested that the quarterly inspections of radiographers and radiographers' assistants should be maintained, the Commission believes that the increased training required for radiographers' assistants, the requirement for the certification of radiographers, and the appointment of an RSO to oversee training and job performance, will compensate for the reduction in the numbers of inspections performed. However, the Commission agrees with the commenters that the benefits gained by these l

f 11

inspections indicate that a semiannual frequency may be preferable and has modified the final rule to require semiannual inspections. The requirement .

for conducting the field inspections for radiographers and radiographers' assistants has been moved to 5 34.43 to more accurately reflect its role in the training program. Additional information concerning the specifics of these inspections is given in 5 34.43(e).

Paragraph (b) specifies that training for industrial radiographers and radiographers' assistants must meet the requirements of 5 34.43. The new requirement to establish procedures to verify the certification status of radiographers applies to previously certified radiographers hired by the licensee. However, the licensee will be required to ensure that all radiographers are certified when this requirement becomes effective, (2 years after the final rule is published in the Federal Register). Section 34.13(b)(2) permits licensees to use certified radiographers before the mandatory 2-year implementation date in lieu of describing its initial training program in the subjects outlined in 5 34.43(g). With the adoption of mandatory certification for industrial radiographers, the final rule has been revised to delete the requirement that licensees include a description of their training program in the radiation safety topics in 5 34.43(g) for radiographers in their license application.

The final rule specifies that licensees must designate an RS0 and potential RSO designees. No change was made in the final rule as requested in the comment described above, because the rule is clear that the RS0's responsibility is to ensure that the radiation safety program is implemented in accordance with NRC regulations and with the licensee's operating and 12

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emergency procedures. Further discussion on the qualifications and duties of this individual are addressed under i 34.42. -

In response to comments on 5 34.27 that testing of radiographic devices for DU contamination should be incorporated in the section on testing of sealed sources for leakage, 5 34.13(h) was added. This paragraph requires that DU shielding, in addition to sealed sources, be tested for leakage. In response to comments received on 5 34.89 that provisions in the proposed rule requiring retention of records at specific locations was overly burdensome, a new $ 34.13(k) was added to' require license applicants to identify the locations where all records will be maintained. This provides the licensees with greater flexibility.

Section 34.20: Performance reauirements for industrial radiography eauipment.

This section specifies requirements for industrial radiographic equipment performance and use. Only a few changes to this section were presented in the proposed rule. The proposed changes primarily addressed equipment modifications and labelling requirements. The proposed rule would have prohibited modification of radiographic exposure devices, and associated equipment. The term, source assembly, was added to 5 34.20(c) to make it clear that it is one of the pieces of equipment that must meet the requirements of 5 34.20. Section 34.20(f) was added in the proposed rule to require labeling of all associated equipment acquired after January 10, 1996, to identify that the components have met the requirements of 5 34.20.

13

Comment.

Six coment letters addressed this section. Three comme ers were .

concerned that i 34.20(b)(1) specifies that the label required for the device was to be attached by the user when in practice most of the information required is supplied or attached by the supplier. j Two commenters expressed concern that the proposed rule did not seem to allow modifications whether they compromised safety or not, which differed from the existing i 34.20(b)(3). One commenter requested examples of I

" reasonably foreseeable abnormal conditions" discussed in 5 34.20(c)(1). One commenter expressed concern over the crushing and kinking tests for the guide tube listed in 5 34.20(c)(5) and stated that the rule implied that each guide tube had to be tested instead of testing a prototype and then using Quality Assurance / Quality Control (QA/QC) procedures in the design of subsequently manufactured guide tubes.

Finally, one commenter was concerned with 5 34.20(f) in the proposed rule that requires labeling of all associated equipment acquired after January 10, 1996. The commenter was concerned that a large amount of associated equipment .

l that meets ANSI N432-1980 and 10 CFR 34.20, and is currently in use is not labelled. Because compliance can be determined only at the time equipment is manufactured, the commenter was concerned that qualified associated equipment may not be authorized for use. The commenter also raised another concern as to what components would have to be labelled. The commenter stated that control gears, guide tube fittings, or outlet nipples are examples of items that it may not be practical to label. The commenter also pointed out that a properly labelled control assembly may not meet the ANSI requirements if one 14

of its components is replaced by a labelled replacement component from a different manufacturer. .

Response.

Sections 34.20(a) and (b).

Minor changes were made in each of these paragraphs to clarify what is meant by radiographic equipment. The terms " source assembly" and " sealed source" were added to 5 34.20(a) and (b) because these items are addressed in the ANSI Standard N432-1980.

Section 34.20(b).

The Commission recognizes that the uanufacturer generally provides much of the information required concerning the equipment initially and generally affixes a label to the device. If a replacement source or source assembly is installed or a licensee's name, telephone number, etc., changes, it is the j licensee's responsibility to make appropriate changes to the label. Although the requirement to have the label attached to the radiographic exposure device by the user has been part of the regulation since 1990 and was not a change made in the proposed rule, the paragraph has been rewritten in the final rule to state that the licensee shall ensure that the information required is attached, whether the information is added by the licensee or by the manufacturer.

In light of the comments received, paragraph (b)(3) of the proposed rule, which prohibited any modification of exposure devices and associated equipment, has been deleted and the existing (b)(3) modification language is retained.

15 l

Section 34.20(c).

In response to a comment requesting an example of a " reasonably .

foreseeable abnormal condition" one example would be where the coupling between the source assembly and the control cable cannot be unintentionally disconnected should the guide tube be severed.

Section 34.20(c)(5).

With respect to the comment received relating to this paragraph, stating that the rule implied that each guide tube had to be tested; this is neither true nor practical. It is the NRC's intent that the tests prescribed involve prototype devices and components. The ANSI Standard N432 covers criteria for the design of new devices and for qualifying prototypes to performance standards. This paragraph, 5 34.20(c)(5), is included in the rule because ANSI N432-1980 contains crushing and kinking tests that are specific for the control cable and the control cable sheath (tube) only. The existing paragraph (c)(5) was intended to apply the crushing tests specified for the controls to the guide tubes, and to apply a kinking resistance test that approximated the forces encountered during use. However, the NRC received a few requests for the use of guide tubes in special applications where the guide tubes could not comply with the crushing test criteria stipulated in the i

standard. Comments received from the airline industry on the 1990 equipment rule (55 FR 843), indicated that the special guide tubes used in testing I aircraft engines would not pass either the kinking test or crushing test specified in the ANSI standard. The NRC's response, at that time, was to state that persons with special requirements apply for an exemption under i 34.51. However, the Commission.has reconsidered its decision, and while 16 l

l

1 concluding that the crushing tests specified in ANSI N432 should be adequate l for the majority of guide tubes in use, the NRC also recognizes that the tests .

specified in ANSI N432 are not sufficient for all cases and that other tests may provide an equal level of safety and may be more appropriate, provided the tests used closely approximate the crushing forces likely to be encountered in normal use. Rather than continue to review case specific exemptions to achieve this, the rule has been modified to specify the use of both crushing and kinking tests appropriate to the conditions of use.

Section 34.20(f).

Paragraph 34.20(f) in the proposed rule, which specified that all l associated equipment acquired after January 10, 1996, had to be labelled to I identify that components met the requirements of 5 34.20, is deleted in the final rule. The NRC is currently re-evaluating the applicability of the ANSI Standard N432-1980 for associated equipment. In response to comments raised on the proposed rule and subsequent comments from a number of licensees requesting interpretation of Information Notice 96-20, issued on April 4, 1996, the NRC will consider the need for an amendment to i 34.20. In the '

interim, NRC inspections will focus on safety issues and incict.ts relating to associated equipment.

Section 34.21: Limits on levels of radiation for storage containers and source changers.

This section specifies the limits on radiation exposure levels for  ;

various equipment associated with industrial radiography. Retric equivalents 4

to values previously cited were added to the proposed rule. Because radiation l

. 17

l exposure instruments currently use units of roentgens to measure radioactivity, the proposed rule specified that measurements taken in .

roentgens could continue to be recorded in terms of roentgens, provided the limits described in the rule would not be exceeded.

Comment.

One comment was received on this section that indicated 5 34.21(b) was

, confusing as written because the language in the proposed rule stated that l

) i 34.21 would only apply to storage containers.

2 Response. l

, i NRC agrees and has rewritten i 34.21 in the final rule to specify the  ;

}

radiation exposure limits for storage containers and source changers and to delete requirements for radiographic exposure devices from this section.

i Because all radiographic equipment in use after January 10, 1996, will be required to meet ANSI N432-1980, the reference to requirements for equipment manufactured before January 10, 1992, is no longer needed and has been deleted l from the final rule.

Section 34.23: Locking of radiographic exposure devices, storage containers and source changers.

! This section requires locking of radiographic equipment to protect the public from inadvertent exposure to radiation. The proposed rule included additional requirements for locking radiographic exposure devices before movement and, if there is a keyed-lock, for removing the key at all times, i

when not under the direct surveillance of a radiographer or a radiographer's assistant.

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Comment.

1 Twelve comments were received on the new proposed 5 34.23(b), ten opposed .

the provision and two suggested word changes. Examples were: l l 1) The requirement to disconnect the control cables from the exposure i device before moving from one location to another in the same immediate area involves too much wear and tear on the source assembly connection. This could lead to equipment fatigue.

2) Industrial radiographers work under less than friendly situations in i

deep and muddy ditches and often under stress. They may also work in situations where one pipeline is tied into another and many radiographs, all within a short distance of each other, are required. Stress is high on the radiographer under these conditions because people are waiting. Requiring the f

disconnecting and re-connecting of cables before moving the radiographic exposure device for successive exposures only a few feet apart would only add l

to that stress and result in judgment errors which in turn could result in possible overexposures.

l l 3) Because many exposure devices now have, and all will soon be required to have, an automatic source securing device, requirir.g that the control

cables be removed before moving the device as little as a few feet is l

unnecessary and adds no additional measure of radiation safety.

4) All of this connecting and disconnecting would drastically increase the introduction of contaminants into the control tube or guide tube and cause excessive wear and would also increase radiation exposure to the extremities of the radiographers concerned.

i 2

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l Response.

l The NRC agrees with the commenters and has deleted the proposed .

l 5 34.23(b) from the final rule and modified the proposed 534.23(a). The final rule contains requirements that the source be secured after each l exposure [5 34.23(a)]. Paragraph (a) in the final rule requires the radiographic exposure device to have a lock or a locked outer container and specifies that it shall be kept locked with the key removed, when not under the direct surveillance of a radiographer or a radiographer's assistant. In addition, 5 34.49(b) requires the licensee to survey the radiographic exposure l device and guide tube after each exposure when approaching the device or the l guide tube to ensure that the source has been returned to the shielded position. The Commission has determined that this requirement provides for l

l adequate safety without the need for additional requirements to disconnect guide tubes before any movement. The proposed rule included the statement ,

that the source be manually secured in those exposure devices manufactured before January 10, 1992. This statement has been deleted in the final rule I because all devices in use after the effective date of this final rule, must l meet the requirements of 5 34.20 including automatic securing.

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Section 34.25: Radiation survey instruments.

This section (previously 5 34.24) specifies requirements for radiation -

survey instruments. The proposed rule included a requirement to perform an L

operability check before use. The proposed rule also reduced the frequency of survey meter calibrations from quarterly to semiannually and provided specific calibration protocols for linear, logarithmic, and digital scale instruments, including an accuracy requirement of plus or minus 20 percent. These changes were made to reflect current calibration standards and to address the variety of survey meters currently available. In addition, the proposed rule required that records of the instrument calibrations be maintained.

Comment.

Ten comments were received on this section. Three commented on the necessity for performing a daily operability check. One commenter objected to using the projection sheath (guide tube) port of a radiographic exposure device as a suitable radiation field for the operability check, and stated that if the source were not properly locked and shielded within the device, it would be possible for the operator to receive an overexposure if the survey meter being checked for operability were malfunctioning. This commenter suggested that a safer method was to use an appropriate check source for the radiation field. Two commenters suggested that some of the newer instruments could retain their calibration for up to 6 months as required by 5 34.25(b)(1), but five felt that a 3-month calibration period should be maintained, citing the rough treatment and hostile environment in which field radiography was performed. One commenter suggested that the calibrations should be made by persons 1. censed by the NRC or an Agreement State.

21

' Response.

The operability check, originally proposed for 5 34.25, has been moved to .

5 34.31 because this section-is a more appropriate location for the requirement. As recommended, the suggested method for performing an

-operability check has been changed to use a check source or other appropriate means. The suggestion that the regulations specify that persons performing-calibrations be licensed by the Commission or an Agreement State is not adopted at this time. The Commission does not believe that the suggested requirement is necessary because licensees must submit operating and emergency procedures with their application under 5 34.13. Because these would include a licensee's calibration procedures, an adequacy review of the calibration procedures would be conducted prior to granting a license. These procedures are reviewed in detail as part of the licensing process, thus adopting an ,

additional requirement to license individuals performing these calibrations could be an unnecessary burden.

The time interval for calibration under 5 34.25(b)(1) was not changed l from the 6-month frequency specified in the proposed rule. However, a j i

requirement to conduct inspection and maintenance of these instruments on a l quarterly basis has been included in 5 34.31. Equipment malfunctions are generally not due to the instrument being out of calibration, but to some other failure. The Commission believes that more frequent calibrations are not needed because significant changes in instrument response should be detected during the daily operability check.

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Section 34.27: Leak testing and replacement of sealed sources.

This section (previously 5 34.25) stipulates that licensees leak test .

sealed sources while in use and radiographic exposure devices that employ DU for shielding. The proposed rule included a requirement that the performance of a source exchange or a leak test must be made by persons authorized by the Commission or an Agreement State. The proposed rule also included a requirement that radiographic exposure devices using DU shielding be tested for contamination at intervals not to exceed 12 months unless the device was in storage, The presence of DU contamination could be an indi<ition of "S" tube wear that could lead to the binding of the control cable with the resultant inability to retract the source. The proposed rule also specified that leaking radiographic exposure devices be disposed of at a facility i

licensed to handle low-level waste.

Comment.

Six comments were received on this section. One commenter stated that the additional test requiring a check for DU contamination could probably not discriminate between a leaking source and DU contamination. Two commenters suggested that DU testing not be required for devices in storage. Another suggested that the DU testing be integrated into the required 6-month leak test for the sealed source. One commenter stated that disposal should not be limited to a facility licensed under 10 CFR Part 61. The last commenter pointed out that DU testing was important since the drive cable travels through the worn part of the "S" tube, and if the wear is significant, the cable picks up uranium contamination and users are exposed to this contamination during connecting and disconnecting controls etc., and while the 23

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

contamination level is low, it is poor health physics practice to allow individuals to have unprotected contact with contaminated items. .

Response.

The NRC recognizes that the detection of DV contamination does not imply that the wear on the "S" tube is sufficient to remove the exposure device from use. However, it is sufficient to require that a borescope or other suitable inspection be made to establish the degree of wear. Most nondestructive evaluation (NDE) firms have the capability to conduct their own inspection.

Firms that.do not have this capability could send the device to the manufacturer or to some other inspection service company for the inspection and evaluation.

The NRC has determined that leak testing services are available that can discriminate between DU contamination and sealed source contamination. The NRC has no objection to increasing the frequency for the DU contamination tests so that they are performed concurrently with the sealed source leak tests. However, the interval between the DU tests must not exceed 12 month:,

unless the device is in storage, with the provision that it be tested before use or transfer. Section 34.27(e) in the final rule has been modified to reflect this change. The requirement for disposal of a DV contaminated dc ice in a facility licensed under 10 CFR Part 61 has been deleted since 10 CFR 40.13(c)(6) exempts natural or depleted uranium metal used as a shielding constituent in a shipping container, provided it is appropriately labelled and the metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of 1/8 inch (3.2 millimeters).

24

l Section 34.29: Quarterly inventory.

This section (previously 5 34.26) specifies requirements for conducting a .

. quarterly inventory. The proposed rule was essentially unchanged from the existing regulation, with the exception of moving all recordkeeping requirements to 5 34.69.

Comment.

One commenter requested an editorial change to this section.

Response. .

In response to the comment, the final rule clarifies that an inventory of all devices that utilize DU shielding is also required.

Section 34.31: Inspection and maintenance of radiographic exposure devices, transport and storaae containers, associated eauipment, source chanaers, and survey instruments.

This section (previously 5 34.28) addresses requirements for the various types of inspection and maintenance activities that licensees must perform to ensure that equipment is in good operating condition, sources are properly shielded, required labels are present, and components important to safety are functioning properly. Records of these inspections and maintenance performed are to be kept for 3 years. ,

The proposed rule extended inspection and maintenance checks to include associated equipment. Associated equipment includes various items used for specific tasks which may not be supplied with the radiographic exposure device. Experience has shown that defects in associated equipment can have an effect on safety. The term routine maintenance was used in the proposed rule 25

l' l to clarify that licensees are not required to perform all maintenance. Many I equipment repairs may require returning the device to the manufacturer. A .

requirement to remove defective equipment from service until repaired was also I included, and that a record of the defect, as well as the corrective actions I taken, must be made.

Comment.

l Three comments were received on this section. Commenters indicated that the daily checks should be more than just visual checks and that they should include operability checks to reveal any equipment problems. The commenters indicated that the components should be maintained in accordance with the manufacturer's specifications and that the recording requirements should include maintenance performed even if this is performed by another, such as the manufacturer. l Response.

The NRC agrees that both visual and operability checks of equipment should be made daily and has modified paragraph (a) accordingly. The proposed rule would have only required that survey instrument operability be evaluated daily with a check source or other appropriate means. By requiring a daily operability check, the likelihood of the radiographer relying on a defective instrument should be reduced. Although it may be a good practice to maintain the equipment in accordance with the manufacturer's specifications, requiring this in the final rule is not necessary, provided the licensee has appropriate procedures for cond~ ting routine inspection and maintenance. The final rule will now require the licensee to have written procedures for the inspection and routine maintenance of radiographic equipment.

l l 26

In response to a comment on 5 34.35 regarding moving the transportation requirements in 10 CFR Parts 71 and 34 to reduce the confusion to licensees, .

the QA requirements for maintenance of transport packages have been included in this section. This, together with a minor conforming change to 10 CFR Part 71, will relieve an existing burden on radiography licensees, who will no longer need to separately submit a transport package QA program description for approval. The prescribed written procedures must include procedures necessary to inspect and maintain Type B packaging used to transport radioactive material.

Section 34.33: Permanent radiographic installations.

This section (previously 5 34.29) specifies the safety requirements that must be in place for any permanent radiographic installation. The proposed rule was basically unchanged from the existing regulation except that daily checks would be required for both the visible and audible alarms in place of testing the alarm systems at intervals not to exceed three months. Entrance controls of the type described in i 20.1601(a)(1) would be tested monthly under the proposed rule, instead of every 3 months.

Finally, the proposed rule would have required that, if an entrance control device or an alarm is operating improperly, it would be labelled as defective and repaired before operations are resumed.

Comment.

Six comments were received on this section. Two of the commenters believed that the monthly testing of entrance controls was redundant if there was also a requirement for a daily test. Two others were concerned that no 27 l

provision was made for surveillance of high radiation areas around the roof of those installations where the shielding is insufficient to reduce the .

radiation below the level of a high radiation area. One commenter expressed a concern that there was no provision for use of the facility should the visual and audible alarms become defective and require some time to repair. Two commenters also suggested that the alarm system be tested with a source rather than by turning on the exposure device.

Response.

The.NRC agrees that the exposure device need not be used to check the alarm system and has changed paragraph (b) in the final rule accordingly. The NRC has added words to help clarify the difference between entrance control devices described in 5 20.1601(a)(1) and the alarm systems described in 5 34.33(a)(2). Daily testing is required for the audible and visual alarms described in 5 34.33(a)(2). Systems whereby the radiation level is automatically reduced upon entry (5 34.33(a)(1)) require monthly testing. The final rule has been revised to allow licensees to continue to use the facility if the alarm system is found to be defective, for a period of up to 7 calendar days, provided the controls needed for a temporary jobsite are in place. The NRC will review any applications where high radiation areas exist outside the permanent installation on a case-by-case basis to ensure that adequate safety controls are in place for these installations.

Section 34.35: Labeling, storage, and transportation .

l This is a new section that specifies requirements for labeling, storage, and transportation of radioactive material used in industrial radiography.

The proposed rule contained requirements to lock and physically secure 28 l

l

transport packages and to store licensed material in a manner that minimizes the danger from explosions or fire. The proposed rule also contained a .

requirement for a QA program, as described in i 71.105.

Comment.

Three comments were received on this section. All requested that the applicable Department of Transportation (DOT) regulations, including the QA requirements on packages, be included in 10 CFR Part 34.

Response.

'l The NRC agrees that certain requirements in 10 CFR Part 71 relating to a QA program should be relocated in 10 CFR Part 34. The Commistion has made a determination that inspection programs for industrial radiography containers meeting the requirements of 5 34.31(b) will satisfy the requirements in i 71.101. While radiography licensees have always had to comply with the QA requirement for transport packages in 10 CFR Part 71, there have been numerous cases where they were unaware of this requirement and, therefore, failed to comply. The inclusion of this requirement in 10 CFR Part 34 will reduce the burden on radiography licensees to submit a QA program for NRC approval

{ separately. Much of the same information on inspection and maintenance that was required as part of the licensn application was similar to that information required for a QA program under 10 CFR Part 71. A revision to I 71.101 has been made to state that the inspection ano maintenance programs l for radiographic exposure devices, source changers, or packages transporting these devices that meet the provision of 5 34.31(b) or equivalent Agreement State regulations, need not be submitted separately as a QA program for 1

Commission approval. This change eliminates the potential for duplicate 1 29 I

l

submission of information and reduces the monetary burden on radiography itcensees because they will no longer be required to pay the fees associated .

with the QA program in 10 CFR Part 71. This change, however, does not relieve radiography licensees from complying with the transport requirements in 10 CFR Part 71.

Section 34.41: Conducting industrial radicaraphic operations.

This new section specifies certain conditions that must be met before performing. radiographic operations in order to ensure that adequate safety measures are in place before conducting radiographic operations. The proposed rule specified that all radiographic operations conducted at locations of use ,

l listed on the license must be conducted in a permanent radiographic installation. The NRC has always believed that radiography performed in a fixed facility, meeting ti e requirements of 5 34.33, would provide a safer environment for workers and the public. If licensees need to perform radiography at their place of business outside of a permanent facility due to some unique circumstances, i.e., item to be radiographed is too large for the facility, Commission authorization would be required. The proposed rule included a requirement for two individuals to be present whenever radiographic operations occur outside of a permanent installation. One of these individuals is required to be a fully qualified radiographer and the other individual is required to be a radiographer's assistant meeting the requirements specified in 5 34.43(c).

30

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Comment.

More than 50 comments were received on this section, 42 in favor and 11 -

opposed. Those not in favor of adopting the two-person requirement cited the additional cost for the second individual as the major reason. Some suggested modifying the requirement to allow use of less qualified people such as security guards for the second individual. Another suggestion was to allow the RS0 to determine when a second individual was required. One comment addressed radiography performed within a factory environment where access could be controlled by one radiographer who could lock access to the site to prevent persons from entering during radiography operations. Those in favor of the requirement cited the increased safety provided by having two individuals present at all times. Several commenters pointed out that the additional cost of th.s provision would be borne by the users with little impact on the licensees. One commenter was concerned that unless explicitly stated, unqualified individuals could be asked to perform duties that should be performed by qualified individuals, for example, rather than using a 2-person crew comprised of a radiographer and a radiographer's assistant, the customer may propose the use of one of its employees as a method to reduce the nondestructive testing company's fees.

Response

The Commission has d1cided to adopt the requirement for at least two qualified individuals to be present whenever radiographic operations are performed outside of a pernanent radiographic installation. The Commission believes that the safety it. sues involved mandate the adoption of this j requirement, particularly when radiography is performed in high places or in i trenches, where problems can most often occur, and where the radiographer 4

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alone is not able to control access. It should also be evident that in case of accident or injury, the second person needed at the site must be more than .

an observer. -The person should have sufficient radiography and safety training to allow him/her to take charge and secure the radioactive material, l provide aid where necessary, and prevent access to radiation areas by unauthorized persons, whereas an untrained person, such as a security guard or contractor's employee as suggested by one commenter, would be unable to perform these functions in a safe manner. The text of this section has been modified to emphasize that the purpose of the second individual is to provide i

immediate assistance when required and to prevent unauthorized entry into the restricted area.

Section 34.41(d) was added to include a requirement to have approved procedures before conducting specific types of radiographic operations such as lay-barge, underwater, and off-shore platform radiography to make NRC regulations more compatible with Agreement State requirements.

Section 34.42: Radiation Safety Officer for industrial radioaraphy.

This new section identifies the qualifications and duties of the RSO for industrial radiography. Previously, these requirements were referenced in regulatory guides and included as license conditions on a case-by-case basis, but not spelled out in the regulations. The NRC believes the RSO is the key individual for oversight of the licensee's radiography program and the person responsible for ensuring safe operation of the program.

The proposed rule specified that to be considered eligible for the RS0 j position, an individual must have a minimum of 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> of documented 4

experience as a qualified radiographer in industrial radiographic operations.

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Among the responsibilities of the RS0 specified in the proposed rule, were the establishment and oversight of all operating, emergency, and ALARA procedures -

and conduct of the annual review of the radiation protection program required by 5 20.1101(c).

Coment.

Twenty comment letters were received on this section in the proposed rule. More than half opposed the provision, primarily on the grounds that mandatory certification and the required 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> of experience in radiographic operations would cause many well trained persons to be disqualified. Several commenters stated that they used RS0s with broad radiation protection experience and academic training for oversight of the radiography and other programs but not for active supervision of radiographic operations. Other comenters stated that NRC should modify its requirement of 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> documented experience in radiographic operations partly because the documented experience could be difficult to verify. One commenter pointed out that there is no existing 40-hour course to prepare sameone to be an RSO for a radiography license. This comenter also pointed cut that there was a 2-day course available entitled Administrators Seminar that covered the specific regulations pertaining to radiography and how to implement an effective program. One Agreement State requested that the experience required for the RSO be broad enough to encompass X-ray radiography. Another comenter suggested that the NRC should consider modifying its requirements to permit fulfillment of the qualifications by more than one individual.

33

Response.

The requirement for 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> of documented experience in radiographic .

operations has been changed to read 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> of hands-on experience in industrial radiographic operations as a qualified radiographer, which is essentially 1 year full-time of field experience after reaching the level of a qualified radiographer, and formal training in the establishment and maintenance of a radiation protection program. What is meant by " hands-on experience" is experience in all those areas considered to be directly involved in the radiography process. These include taking radiographs, surveying devices and radiation areas, calibration of survey instruments, operational and performance testing of survey instruments and devices, film development, posting of radiation areas, transportation of radiography equipment and travel to temporary jobsites, posting of records and radiation area surveillance etc. Excessive time spent in only one or a two of these  !

operations (such as film development or radiation area surveillance) should not be counted toward the 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> under consideration. Limited experience with radiography utilizing X-rays can be included. However, because there are greater safety concerns asscciated with the use of exposure devices utilizing gamma radiation than there is with use of an X-ray device where the radiation field can be shut off, the majority of this experience should be in isotope radiography. The 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> time period was selected to ensure that the RS0 '

l has sufficient radiographic experience to be able to clearly oversee the safety aspects associated with industrial radiography. Because utilization logs are already kept for 3 years, no additional documentation of a l radiographer's experience would need to be maintained. This change is based l in part on the comments received at the December 1994, workshop held in

! 34

Houston, Texas. A number of licensees attending the workshop maintained that requiring documentation of 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> would be overly burdensome. .

A provision for the NRC to consider alternatives, based upon the licensee's submittal of the proposed RS0's credentials, has also been added to .,

provide flexibility for licensees that engage in other activities involving NRC licensed material where the RS0 would not likely be a radiographer but would be a radiation protection professional. The qualifications, training, and experience required of the RS0 will vary depending upon the complexity of the licens.ee's operations and the number of individuals potentially involved.

In response to comments at the December 1994, workshop in Houston, Texas, the requirement for the RSO to have formal classroom training related to the radiation protection program, has been modified to delete the requirement that it be a 40-hour course. The primary requirement is that the training properly addresses the appropriate subjects without regard to specification of the hours spent. Other minor word changes have been made for clarification. In response to a comment, paragraph (c)(5) has been changed to clarify that the RS0s must have the authority to assume control for instituting corrective actions, including stopping operations when necessary in emergency situations or unsafe conditions.

Section 34.43: Trainino.

This section addresses training requirements for industrial radiographers and radiographers' assistants. Section 34.43(a) in the proposed rule was revised to require radiographers to be certified by a certifying entity meeting the criteria specified in Appendix A to 10 CFR Part 34.

35

In addition, the proposed rule incorporated some additional training in l NRC regulations for radiographers' assistants, required written tests for .

radiographers' assistants, required annual refresher safety training for radiographers and assistants, and reduced the frequency of inspection of l radiographers and assistants from quarterly to annually.

Training subjects previously listed in Appendix A were moved to 5 34.43 (g) in the proposed rule. Several additional topics were also included: pictures or models of source assemblies; training in storage, control, and disposal of licensed materials; and other pertinent Federal regulations (i.e., DOT). The requirement for annual refresher safety training ,

l was included in the proposed rule to clarify what was meant by the term {

" periodic training" in the existing regulation. Licensees are expected to address new information since the employee's last training, such as new equipment or revised operating and emergency procedures, and safety issues.

Comment.

1 Sixty-one comment letters were received on this section, most commenting l on the certification provision. Four of the comment letters were directed against 5 34.4?(d), which reduced the inspection of the job performance of radiographers and radiographers' assistants to an annual inspection in place of the current quarterly inspections. The remainder of the comments addressed mandatory certification. Forty-three were in favor and 14 opposed to certification. Some of the larger licensees stated that their training i programs were superior to what was being proposed and that adopting this l

l requirement would force them into having to participate in a duplicate program without any corresponding safety benefit. Other commenters were opposed 36 t

because of the cost involved in implementing the program. Also, some licensees believed that they should be granted exemptions because their in- -

i house certification programs were somewhat site specific and specialized and

)

would not qualify their radiographers to compete in the commercial industrial radiography market without further, more generalized training. j Response.

After consideration of the comments received, the Commission has decided to adopt mandatory certification requirements for industrial radiographers to provide a consistent standard by which training of all radiographers can be i measured. Individual licensees will have less of a burden in confirming the training status of a newly hired radiographer through a national certification l l

system. While the final rule reduces the burden on licensees by no longer requiring them to submit descriptions of their training programs for the subjects listed in 5 34.43(g), licensees still must ensure that newly hired individuals have completed, or are provided, the appropriate training in the subjects listed in 5 34.43(g) and a period of on-the-job training. Licensees still must provide instruction in omergency and operating procedures, as well as any specific requirements in their NRC license. The final rule includes additional flexibility, in that, either written or oral tests may be used to test a radiographer's knowledge of this information but that in either case, the records required by 5 34.79 must be maintained as specified.

To be recognized as a certifying entity, an independent organization meeting the criteria specified in Part I of Appendix A will have to apply as specified in i 34.43(a)(1). A list of certifying entities will be made available to licensees on request by contactit g the appropriate regional office listed in Appendix D to 10 CFR Part 20 and will be published annually 37

in the Federal Register. Licensees will have 2 years to implement this certification requirement. During this time, the licensee may allow an . .

individual who has not met the certification requirements to act as a radiographer if the individual has received training in the subjects outlined in paragraph (g) of this section and has successfully completed a written test approved by the NRC.

The Commission recognizes that some of the larger licensees may believe l they have a superior program to that currently being offered by the existing certifying. organizations. These licensees will still be able to provide

! training as they currently do. Any additional burden from having their radiographers tested by an independent certifying organization should be minimal.

In response to comments, 6 34.43(e) is modified in the final rule to require inspections of radiographers and radiographers' assistants on at least a semiannual basis. With the required certification of radiographers and the additional training required of radiographers' assistants, the Commission believes that reducing these inspections from a quarterly to a semiannual

basis is justified. Nothing in the regulations prevents a licensee from l

l conducting these inspections more frequently. Radiographers or radiographers' assistants who have not participated in industrial radiographic operations for more than 6 months will be required to demonstrate their knowledge of the training requirements of 5 34.43(b)(3) and 5 34.43(c)(3), respectively, by a practical examination before their next participation in radiographic operations. Flexibility has been provided in 5 34.43(e) of the final rule for situations where the RSO also serves as a radiographer. In such cases, e

i 38

licensees must include information in their application as to how they will ensure that the proficiency of the radiograp. . is maintained. .

I Section 34.45: Operatinc and emeraency procedures.

This section (previously 5 34.32) identifies the procedures that  ;

licensees must develop and submit to the NRC in their application. The  ;

proposed rule included only minor changes to this section to assure that all l activities (e.g. source recovery) carried out by the licensee involving )

radioactive material were covered by appropriate procedures. l Comment.

Four commenters addressed this section. One commenter was opposed to allowing an organization to retrieve a source unless they had submitted extensive emergency and training procedures to the NRC. Another commenter stated that, although there are basic principles that apply to any source recovery, each specific source recovery exhibits unique characteristics and/or peculiarities and that specifics for source recovery would be better addressed

) in a separate procedure that is referenced in the regulation. The third I commenter requested adding a requirement for inspection, maintenance, and operability checks on survey instruments, clarification of procedures for identifying and reporting defects and malfunctions under 10 CFR Part 21 and i 34.101, and recommended that source recovery procedures should include the 1

topics: advance preparations, initial response, retrieval planning guidelines, retrieval operation guidelines, and post-retrieval tasks. The fourth commenter noted that each source recovery is unique so the procedures j need to be kept generic and flexible. Comments on another section suggested 39 1

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

that the Commission should address procedures for lay-barge, offshore platform, and underwater radiography because licensees may elect to perform .

these activities.

Response.

Because the Commission believes that licensees should have the flexibility to recover sources, no change has been made in the final rule concerning source recovery procedures. In response to other comments, survey instruments and transport containers have been included in the paragraph l

requiring . inspection, maintenance, and operability checks. With regard to clarification of procedures for identifying and reporting defects and malfunctions, 134.101 requires notification of the NRC only when a defect or malfunction is observed that corresponds to any of the incidents described under i 34.101(a). Additional reporting may be required for incidents that meet the definition of a " defect" under 10 CFR Part 21, and do not fall into any of the three categories in i 34.101.

In response to comments made at the December 1994 workshop in Houston, Texas, paragraph (a)(8) was revised to clarify that corrective action is not required if the alarm ratemeter alarms at an expected time, such as when the l i

source is being cranked in or out of the device.

The NRC did not adopt a provision for submitting procedures for lay- i barge, offshore platform, or underwater radiography for licensees who intend to perform these activities. Licensees who elect to perform these activities must address the applicable procedures with license submission.

l 4

j 40

Section 34.46: Supervision of radiographers' assistants.

This section (previously 5 34.44) specifies requirements for .

radiographers' assistants to handle equipment associated with radiographic operations. The proposed rule included no chariges to this section.

Comment.

No comments were received on this section.

i I

Section 34.47: Personnel monitorina.

This section (previously 5 34.33) addresses requirements for monitoring radiation exposures to radiographic personnel. The proposed rule specified that pocket dosimeters must have a range of 0-200 millirems, and included a requirement to read pocket dosimeters at the beginning and end of each shift to ensure that the dose.is correctly estimated. This requirement was included because it is nearly impossible to recharge a pocket dosimeter to zero.

Therefore, licensees must take a reading before and after use and determine  ;

the difference. The proposed rule provided criteria for allowing a worker to  ;

return to work when a pocket dosimeter is found to be off-scale. Paragraph (a) of the final rule requires workers to wear their dosimeters on the trunk i of the body in order to measure whole body dose as defined in 10 CFR 20.1003.

The dose to the extremities (again as defined in 10 CFR 20.1003) is to be measured only with appropriate extremity dosimeters. Paragraph (e) in the proposed rule specified that a worker must cease work whenever a film badge or i a thermoluminescent dosimeter (TLD) is lost until a replacement is provided to ensure that there is an accurate means to determine the worker's dose. The proposed rule included a provision that, after replacement, each film badge i

l 41

and TLD must be promptly processed and that alarming ratemeters be capable of alerting the wearer regardless of the environmental conditions. .

Comment.

The NRC received twenty-eight comment letters on this section. Several commenters wanted to be able to use additional dosimeters with higher ranges to supplement those specified in 5 34.47(a)(1). One comenter asked whether digital dosimeters (electronic personal dosimeters) could be used in place of pocket dosimeters since their range was considerably greater than the range specified for pocket dosimeters and also asked whether they could be used in place of an alarm ratemeter. Two comenters opposed replacing TLDs on a monthly basis because of the additional cost with no discernable increase in safety. A commenter wanted pocket dosimeters to be calibrated every 6 months in place of the specified 12 months and requested that the acceptable range ,

1 for dosimeter readings be set within plus or minus 20 percent. Nine commenters opposed 5 34.47(g)(3) because it required alarm ratemeters to alert the wearer regardless of environmental conditions. A number of comments were received at the December 1994 workshop in Houston, Texas relating to proposed requirements for TLD exchanges, alarming ratemeters, and the use of electronic personnel dosimeters. Suggestions were made to lower the preset dose rate specified in the rule below 5 mSv/hr to allow licensees the flexibility of using a lower dose rate if they choose. Other comments indicated that I radiographers often rely on alarming ratemeters to alert them that the source has not been retracted into the camera rather than performing a survey to verify that the source is properly stored. Because of this, these commenters believed that the requirement to always wear an alarming ratemeter should be

[ 42

i removed from the regulations. A number of licensees at the workshop stated that it would be extremely difficult and costly to obtain ratemeters that are .

capable of alerting the wearer in the wide variety of environmental conditions under which they work. A number of commenters at the workshop did not agree with lengthening the replacement frequency for TLDs to quarterly on the basis that frequent checks of workers' doses were needed due to the potential for t.igh doses. Several commenters requested flexibility to use electronic personnel dosimeters in place of pocket dosimeters and stated that pocket dosimeters.were increasingly difficult to obtain. One commenter recommended continued use of pocket dosimeters rather than electronic personal dosimeters and reported that supplies of pocket dosimeters were still available.

Response.

The final rule allows replacement of TLDs on a 3-month basis. The comments of the Agreement States requesting continuation of the monthly frequency were not adopted. The RSO is responsible for ensuring that worker doses are maintained ALARA. The purpose for requiring pocket dosimeter readings to be recorded daily is to ensure that worker doses are maintained ALARA. The requirement to replace film badges monthly was not changed because film badges are not rugged enougii to withstand environmental conditions for 3 months without the film housing developing light leaks or absorbing  ;

moisture.

The NRC did not change the final rule to permit use of pocket dosimeters with ranges greater than 0-200 millirems. This ensures that emergency l procedures are implemented when doses exceed 200 mrem. Licensees are free to use additional pocket dosimeters with higher ranges for informational purposes. The NRC has agreed to change the accuracy. requirement for pocket 43

_m._.____ _ . _ _ _ _ _ . _ _ _ . _ _ _ . _ _ _ .__ _ ~ _ _ _ _ _ _

1 i

i dosimeters to 20 percent to more closely match the recommendations in 1

j. ANSI N322 and ANSI N13.5. The calibration period of pocket dosimeters was not .

I changed because this is the maximum period recommended in ANSI N323.

3 l

The requirement that alarming ratemeters be sufficient to alert the I

wearer regardless of environmental conditions has been dropped from the final j rule. Licensees are expected to make a reasonable attempt to select alarming i ratemeters that will function properly for the conditions under which they will be used.

f Although a number of individuals at the December 1994 workshop in l Houston, Texas, believed that the use of alarming ratemeters results in radiographers failing to make the proper surveys, the evidence the Commission i

has seen demonstrates that overexposures have decreased since this requirement went into effect. Therefore, the NRC continues to believe that the proper use of alarming ratemeters may be an effective means for preventing overexposures.

The NRC has decided not to make any changes in the alarm point requirement.

The use of a lower limit would likely result in frequent alarms that could have a negative impact because the wearer would be more like'1y to turn off the  ;

l ratemeter to avoid an alarm. The purpose of alarming ratemeter is to alert j the wearer of an abnormal condition requiring prompt action to reduce the likelihood of an inadvertent overexposure.

Finally, in response to comments from licensees at the Houston, Texas, workshop, the final rule has been revised to allow the use of electronic personnel dosimeters in lieu of pocket dosimeters as a direct reading dosimeter. Those electronic personal dosimeters that also have tiarm ratemeter capabilities are not to be used as a substitute for alarm ratemeters I at-the present time. Individuals acting as a radiographer or radiographer's 44

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

l assistant must wear direct reading dosimeters, an operating alarm ratemeter, and either a film badge or a TLD during radiographic operations. .

Section 34.49: Radiation surveys.

This section'(previously 5 34.43) addresses requirements for surveys that must be made during and after radiographic operations to ensure that the t

radioactive source is safely secured when radiographic operations are not being performed and that public dose limits in 10 CFR Part 20 are met. The proposed rule included a number of revisions to this section. The first of ,

these was to replace the 360" survey of the exposure device with a requirement tc conduct a survey when approaching the exposure device and the guide tube I prior to exchanging film, repositioning the collimator, or dismantling equipment. The proposed rule also required conducting an adequate survey any time the source is exchanged and whenever a radiographic exposure device is placed in storage. l l

l Comment.

Eight comment letters were received on this section. One commenter noted that a number of NRC licensees have been fined in the past for failing to do the 360* survey of the radiographic exposure device and the guide tube evictly as designated and now the NRC is deleting the requirement. One commenter i

I pointed out that it is unnecessary to survey the storage area at the time of i

)

. quarterly inventory because there is already a requirement for surveying I whenever storage conditions change, i.e., whenever radioactive material is

! added to or removed from the storage area. The last commenter noted that '

i 5 34.49(f) would require the maintenance of records per 5 34.85, which in turn i 45

states that survey records to-be maintained are those of the last survey performed in the work day as specified in 5 34.49(d). The commenter was .

concerned that records would be interpreted as measurements of all of the 12 to 18 measurements specified in 5 34.21, and suggested a single measurement made at the outlet port of the radiography device each day would provide an adequate record and also any significant change in the reading obtained at I this position would be an indication that the source was not in its fully shielded position.

Response. , )

In response to these comments and additional coimnents from the workshop l

in Houston, Texas, the final rule has been change.d to clarify that the intent of the requirements in il 34.49(b) and (c) is to conduct a survey to ensure

-that the source is in the shielded position. This can be accomplished by surveying the radiographic exposure device and comp. 'ng the reading obtained to the reading expected when the source is known to be in the device.

The requirement in the proposed rule to survey the storage area initially and at the time of the quarterly inventory has been removed. Because i34.49(c) requires a survey whenever a radiographic exposure device is placed in storage, and 5 20.1302 alteady requires licensees to demonstrate compliance with the public dose limits, licensees are expected to establish a program to ensure that storage areas meet these requirements. Section 34.49(d) requires that a record of the last ' survey be maintained for each device prior to placing the device in storage for the day.

46 l

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b c Section 34.51: Surveillance.

, This section (previously 5 34.41) specifies requiroments for .

l radiographers to maintain surveillance of a high radiation area during industrial radiographic operations to protect against unauthorized entry. The proposed rule was basically unchanged from the existing rule except the l requirement specified " continuous" direct surveillance. References to 10 CFR  !

l l Part 20 were updated to reflect the changes made to 5 34.33, Permanent l Radiographic Installatior.s. In response to coments at the December 1994, 1

workshop in Houston, Texas, the final rule has been amended to clarify that, I for radiographic operations that employ 2-person crews, surveillance may be l

performed by the radiographer's assistant.

l l

Coment . l 1

No coments were received on this section. I Section 34.53: Postina.

This section addresses requirements for identifying areas where radioactive material is being used to comply with radiation protection requirements discussed in 10 CFR Part 20. The proposed rule made only minor changes to this section.

Coment.

One coment letter was received on this section. The comenter suggested that areas where radiography was being performed should be posted with signs

bearing the words " KEEP OUT" because the usual "CAVTION" and " DANGER" signs l

[ are inadequate at temporary job sites. The comenter also suggested that the 47 f

e 4 rope or tape used to post restricted areas for radiography be colored magenta and yellow. The commenter believed that it was important to clarify that .

"Very High Radiation Areas" need not be posted during industrial radiography because radiographic operations may create areas which meet the posting requirements of 520.1903(c).

Response. ,

No change was made to the final rule to exempt posting of very high radiation areas. Most industrial radiography programs are limited to the use of sources.that do not create very high radiation areas as defined in 5 20.1003. For licensees who intend to use radiation devices capable of creating very high radiation areas, considerations of posting and restricting these areas will be dealt with on a case-by-case basis during the licensing process.

Subpart E-Recordkeepina Reauirements.

This new subpart places all recordkeeping and notification requirements for 10 CFR Part 34 in one location.

Section 34.61: Records of specific licenses for industrial radiography.

This new section in the proposed rule requiros licensees to maintain a copy of their licenses until their licenses are terminated by the Commission.

Comment.

No comments were received on this section.

r 48 i

o .

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1 Section 34.63: Records of receipt and transfer of sealed sources.

This new section in the proposed rule requires licensees to maintain -

I records of receipt and disposition of radioactive sources used under their license. The requirement includes any devices containing shielding material using DU. In the case of such devices, the mass of DU designated by the manufacturer would be included in place of the activity.

Comment.

Only minor editorial comments were received on this section. l l

Section 34.65: Records of radiation survey instruments.

l This new section of the proposed rule contains the recordkeeping requirements for radiation instruments required under 5 34.25. The l recordkeeping requirements were previously included in existing 5 34.24. This section would require licensees to maintain calibration records for radiation survey instruments for 3 years after the record is made.

l l

Comment.

One comment letter was received on this section. The commenter requested i

l that the operability check required under 5 34.25 be included in the records l maint-ined under this section.

Response

The financial burden involved in recording daily operability checks under this section is felt to be prohibitive. Section 34.73 has been modified in i

4 the final rule to only require records of any problems encountered during

, operability checks.

49 l

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l Section 34.67: Records of leak testina and replacement of sealed sources.

This.new section contains recordkeeping requirements previously included .

in i 34.25(c) and requires licensees to maintain records of leak tests for 3 years after the record is made.

l i

Comment.

No comments were received on this section.

l Section 34.69: Records of cuarterly inventory.

This new section contains recordkeeping requirements previously contained

in i 34.26 and requires licensees to maintain records of quarterly inventories for 3 years after the record is made. The proposed rule required some additional information be kept, such as model number, serial number, and

manufacturer of the sealed source.

1 Comment.

)

One comment letter was received stating that the record should include all licensed devices whether or not they contain a sealed source at the time of inventory.

l Response.

Section 34.29 was revised in the final rule to include devices containing l

depleted uranium.

~

i Section 34.71: Utilization loas. 4 l This new section contains recordkeeping requirements previously included 1

in 5 34.27. The proposed rule would have required additional pieces of 50 l

l

--:. -----,,a u 1. -- - _ a A L information including the serial number of the device in which the sealed l source is located, the radiographer's signature, and the dates the device is .

removed from and returned to storage. This information is needed to assist in

! verifying the location of sources.

l Comment.

Three comment letters were received on this section. One commenter l

l pointed out that the RS0 may control the utilization log at the main office and, because the device could be at a field station many miles from the main office, signatures of the radiographers on the utilization log was not practical. The second commenter stated that the utilization log should include all devices removed from storage, not only those containing a sealed source at the time of removal. The third commenter requested removal of the requirement to include the radiographer's signature.

Response.

l Licensees at the December 1994 workshop in Houston, Texas, stated that l their radiographers were signing the log as required and either mailing or i

l faxing a copy of the document to the RSO after all signatures for the day were l

collected. The radiographer's signature is needed to ensure that only a j qualified individual has checked out a radiographic exposure device. This l

l provision was retained in the final rule.

l An exposure device not containing a sealed source will not be utilized l within the context intended in 5 34.71. If the radiographer intends to load a 1

sealed source into the empty exposure device, then a storage container which contains a sealed source must be checked out as specified in 5 34.71(a)(1) and 51 1

. - . _ . . = . =.

an entry made in the utilization log. This provision was retained in the final rule. .

Section 34.73: Records of inspection and maintenance of radicaraphic exposure devices. storage containers. associated eauipment, source chanaers, and survey instruments.

This new section contains recordkeeping requirements previously contained in 5 34.28(b). The proposed rule specified that inspection and maintenance records mu.st be maintained by the licensee for 3 years. Licensees must maintain records of equipment problems and of any maintenance performed under 5 34.21 (a) and (b). The records must include information, such as dates of checks, name of inspector, equipment inspected, any defects found, and repairs made.

I Comment. l i

Two comment letters were received addressing this section. The first letter requested that the highest radiation level measured at the beginning of each day from devices or source changers removed from storage should be recorded and used as a reference to provide a baseline for comparison with measurements taken from later surveys to ensure no change in the shielding was occurring. The second letter requested that the records compiled under j l

5 34.73 should include inspection records of survey instruments, equipment ]

1 problems, and records of maintenance performed. j l

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52 j l

i

Response.

l l The first comment was not adopted because sufficient requirements are .

already in place under 5 34.49 and i 20.1302 to ensure that licensees are.in compliance with the public dose limits. Licensees may choose to include

~

additional information in their records to assist them in assuring that there are no changes occurring in the shielding integrity. The requests of the L second commenter. have been incorporated in 5 34.31 in the final rule.

l Section 34.79: Records of trainina and certification.

This new section includes recordkeeping requirements previously included in 5 34.31(c). The proposed rule also specified that records verifying radiographer certification and annual safety reviews are to be retained for 3 years after the record is made. For annual safety reviews, the records include copies of tests, dates administered, names of instructors and l

attendees, and the topics covered. The proposed rule also specified that records of inspections of radiographers and radiographers' assistants must include a list of items checked and any non-compliances observed by the RSO.

i l

! Comment.

l Two comment letters were received on this section. One requested that the wording be changed to eliminate " copies of written tests" and replace it with " licensee administered written tests." The other requested minor editorial changes.

Response.

The wording has not been changed because in many cases the training and j testing may be given by outside consultants or companies that specialize in i

. 53 i

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. o i

such training and testing. The term " annual safety review" was changed in the final rule to " annual refresher safety training" to clarify its role in the .

licensees' training program.

Section 34.81: Copies of operatina and emeraency procedures.

l This new section includes requirements previously included in i 34.32 and would have required licensees to maintain copies of emergency and operating procedures until the Commission terminates the license.

l I

Comment. l No comments were received on this section.

i Section 34.83: Records of personnel monitoring.

This new section includes recordkeeping requirements previously included in 5 34.33(b) and would have required licensees to maintain records of alarm ratemeter calibrations, pocket dosimeter readings, and operability checks for l 3 years from the date the record was made, and maintain records of film badge L

l or TLD reports until the Commission terminates the license (s).

Comment.

One commenter requested that records of daily operability checks and quarterly inspections of survey instruments should be included in this 1

section. I Response.

These records are already required under 5 34.65. Therefore, no change l was made to this section, i

1 54 1 l

.._ -. . . _ _ . _ . . . _m . _ _ _ _ ..__. _ _ _ _ _ _ . . _ . . _ . ...

o e- ,

Section 34.85: Records of radiation surve_vs_.

This section (previously 5.34.43(d)) was essentially unchanged in the -

proposed rule.. The proposed rule would require the licensee to maintain records of exposure device surveys conducted before the radiographic exposure device is placed in storage-for 3 years'from the date the record was made.

l l

Comment.

No comments were received on this section.

l l

l Section 34.87: Form of records.

, This section (previously i 34.4) of the proposed rule was unchanged from

! the current regulations. This section of the proposed rule specified how records must be maintained, including storage by electronic media.

l Comment.

No comments were received on this section.

Section 34.89: Location of Documents and records.

l This new section addresses requirements for licensees to maintain certain l

l records at locations where radiographic operations occur, such as at a permanent installation, temporary jobsite, or field station, where radioactive material is stored and from which it is dispatched for use at a temporary jobsite. Two sections were included in the proposed rule to ensure that licensees have records available at the appropriate locations to maintain safe operations. The records include a copy of the license, copies of pertinent NRC regulations, utilization records for the devices in use at the temporary e

55

I jobsite, records of equipment problems, records of alarm system checks for permanent installations located at a temporary jobsite or field station, .

l personnel monitoring records, operating and emergency procedures, evidence of latest calibrations and operability checks of personnel monitoring devices, l

latest survey records, and shipping papers.

Comment.

Three comment letters addressed this section. One commenter believed that the 1.icensee should have more discretion regarding which records to keep at each particular site, while all three commenters stated that the requirements were confusing and would lead to voluminous record keeping.

Response.

In the final rule,134.89 specifies requirements for the minimum set of records to be maintained at field stations and temporary jobsites. This set  ;

of records is the minimum needed to ensure that the licensee can conduct radiographic operations safely and to demonstrate that they are in compliance with NRC regulations. The licensee has the discretion to determine the location for all other records required to be kept under 10 CFR Part 34 and other applicable parts of NRC regulations.

Section 34.101: Hotifications.

l This section of the proposed rule addressed requirements previously in l l

5 34.30, for licensees to notify the NRC of incidents having safety significance. The proposed rule contained a new requirement to inform the l appropriate NRC regional office (generally, where the license was issued) in 56 l

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

writing before using or storing radioactive material in any location for more than 180 days. .

Comment.

One coment was received requesting clarification between malfunctions that are to be reported under this section and defects that require reporting under 10 CFR Part 21.

Response.

The final rule was changed to acknowledge the reporting requirements in 10 CFR Parts 21 and 30. However, as noted in the response to i 34.45, 534.101 requires NRC notification when a defect or malfunction i.e 1bserved that corresponds to any of the incidents described under that i 34.101(a),

j regardless of whether additional reporting is required by other parts of this j chapter, such as 10 CFR Parts 21 and 30.

Section 34.111: Applications for exemptions.

This section of the proposed rule addressed exemptions and was basically the same as i 34.51 in the existing 10 CFR Part 34, with the exception of i

minor wording changes to make it consistent with current language used in other parts of the rule.

l l Comment.

No comments were received on this section.

57

l I

Section 34.121: Violations.

This section in the proposed rule addressed violations and was basically -

the same as i 34.61 in the current 10 CFR Part 34.

Comment.

l No comments were received on this section.

Section 34.123: Criminal penalties.

This section of the proposed rule addressed criminal penalties and was basically the same as i 34.63 in the current 10 CFR Part 34.

i Comment.

No comments were received on this section.

Appendix A. l l

This appendix was new in the proposed rule. The requirements in Appendix A in the current 10 CFR Part 34 were relocated to i 34.43(g). Part I of Appendix A in the proposed rule provided the requirements for an independent certifying organization and only applied to organizations other than the Agreement States. Parts II and III of Appendix A in the proposed rule provided the requirements for certification programs and written examinations for a certifying entity, and included the Agreement States.

The proposed rule specified that to be recognized as an independent certifying organization, the applicant should be a national society or i

association involved in setting national standards of practice for industrial i

radiography.

1 l 58

l An acceptable certification program would include training in the ,

1

subjects listed in 5 34.43(g), completion of a written and practical .

l l examination, and a minimum period of on-the-job experience.

l Comment.

Four comment letters addressing this section were received. One commenter questioned how the technical content of the examination could be at a ninth-grade reading level and expressed a view that the requirement for a l scientifically malyzed question base in III.4. was vague and should be l clarified. Anott,ar commenter felt that III.4.,5., and 6. should be deleted l l

l and combined into a new section that should specify analysis using nationally-l recognized psychometric examination methods. Several of the commenters asked why such a large population of questions was required. The G-34 Committee of the Conference of Radiation Control Program Directors (CRCPD) on Industrial Radiography provided numerous comments of a clarifying nature, including that:

An independent certifying organization should be open to nonmembers as well as members; A full-time staff may not be needed if the program is small; l References to applicable 10 CFR Part 34 sections should also include

" applicable Agreement State regulations";

Provisions in II.4, 6, and 8 (revocation, sanctions, and renewals) be incorporated into one section; Written procedures should be required for all aspects of the program, including safeguards for ensuring adequate proctoring of examinations.

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l Response.

The final rule was changed to clarify that the certification program for .

any independent organization should be open to nonmembers as oil as members.

The provision in I.5 of the proposed rule that specified a full-time staff has 1

been changed to specify an " adequate staff" to reduce any possible burden on i organizations operating a small program. The organization would still have to demonstrate that the staff was adequate to administer the program.

Section I.11 was expanded to specify that independent certifying organizations must have procedures for proctoring examinations, including proctor qualifications, which clarify that there are other qualifications beside the proctor not being employed by the same corporation as the examinees.

Sections II. 4, 8, and 9 were removed and replaced with a revised requirement that the certifying entity must have procedures for denying an application, revoking, suspending' .and reinstating a certification, because a number of Agreement States expressed concern at the December 1994 workshop in Houston, Texas, that they would be prohibited from revoking a certificate without providing an opportunity for due process.

In regard to the questions relating to the scientific analysis of tests and to the number of questions required in the question bank, the NRC

, consulted experts in the testing field and has revised the final rule to specify that test items must be drawn from a question bank containing psychometrically valid questions. Additional guidance on the creation and

]

analysis of tests will be provided in Regulatory Guide 10.6.

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60 i l

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! 10 CFR Part 150: Exemptions and continued regulator _y authority in Agreement .

l States and in offshore waters under Section 274 Section 150.15b of the proposed rule was added to clarify that the Comission reserves the authority to establish minimum standards regarding

radiographer certification and independent certifying organizations, and to identify acceptable certifying entities.

l Comment.

Two comments were received regarding this section from Agreement States objecting to the language that reserves the authority over certification to l the NRC. Part of the objection was based on the fact that the first testing for radiographer certification began in Texas and that the current state of i the national c- tification program is the result of cooperative development by a working partnership of Agreement States, the NRC, ASNT, CRCPD, and others.

I The commenters believe that the current wording of this section is contrary to the working partnership that led to the current state of certification development. The commenters also believe that the restriction imposed by this section would prevent current certifying entities from making improvements in their programs as the process for certifying radiographers continues to evolve. They also expressed concern that the language could result in

( automatic noncompliance for many and suggests that the Commission consider grandfathering those entities already operating and established at the effective date of the revision to 10 CFR Part 34.

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• 4 1

l

Response

The use of the language in 5150.15b was chosen in the proposed rule -

because the requirements identified in Appendix A only apply to independent certifying organizations and certifying entities. The Commission agrees that certain States may wish to identify an independent certifying organization and has deleted this section from the final rule. The Commission does not intend to retain sole authority for establishing standards for independent certifying organizations or certifying entities. However, in order to maintain a national certification program, whereby radiographers would be able to work in several States without needing to be recertified in each State, uniformity of these programs is essential. Any State choosing to identify an independent certifying organization or choosing to be a certifying entity would be expected to follow criteria compatible with those in Appendix A. NRC will continue to work cooperatively with the Agreement States to coordinate activities associated with the implementation of the radiographer certification program.

III. Conforming Rule Changes As a result of the overall revision to 10 CFR Part 34, conforming changes to 10 CFR 30.4 and 10 CFR 150.20 are required. These changes include removal of definitions in 10 CFR Part 30 for Radiographer, Radiographer's assistant, Radiography. These definitions are different from those in the final 10 CFR Part 34, and because they are not used in 10 CFR Part 30, they are being deleted from this part. Section 150.20 (b) is being revised to include the new subparts that were added to the final 10 CFR Part 34. j l

62 l i

E. Although Appendix A is designated as compatibility Division 2, the Agreement States are not required to implement a program unless they choose to .

become a certifying entity and then would only need to adopt Sections II and III of Appendix A. If an Agreement State chooses to identify an independent certifying organization, then it would need to also adopt Section-I of Appendix A.

V. Implementation The new requirements become effective 30 days after publication of the ,

final rule in the Federal Register, although the Commission intends to have different implementation dates for particular requirements of this final rule.

For use/ storage locations not previously identified on the license (e.g., l field stations, permanent radiographic installations, and temporary jobsites exceeding 180 days), licensees must request amendments or notify the NRC, as appropriate, within 60 days of the effective date of the rule. Few amendment requests are anticipated.

Licensees will have 1 year from the effective date of the rule to comply with the additional training requirements specified in 5 34.43(a) and (b). I Licensees should consider combining this training with the annual refresher safety training.

Licensees will have 1 year from the effective date of the rule to hire and train individuals to meet the requirements of 5 34.41(a).

All current RS0s will have two years to implement the additional RSO training requirements specified in 5 34.42(a), and to comply with the mandatory certification requirements in i 34.43(a)(2).

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IV. Agreement State Compatibility Sections of the rule will be a matter of compatibility between the NRC -

and the Agreement States, providing consistency between Federal and State safety requirements. Under current NRC procedures, radiographic equipment safety standards, training standards, operational safety standards, and technical definitions, are identified as Division 2 matters of compatibility.

The final rule is retaining the existing Division 2 designations for moct requirements.

The definitions and sections that will not be compatibility Division 2 are as follows:

! A. The definitions for ALARA, becquerel, gray, sealed source, and sievert are compatibility division 1 in this rule. These definitions, however, duplicate definitions contained in other parts of this Chapter. The States will only need to adopt them once.

B. The definitions for lay-barge radiography, radiographer's assistant, j and underwater radiography are considered to be special cases of Division 2.

l If a State does not authorize licensees to perform lay-barge, or underwater ,

l radiography, or does not permit the use of radiographer's assistants, then it i will not be required to adopt these definitions.

C. The following sections are compatibility Division 3: il 34.1, 34.5, 34.11, 34.111, 34.121, and 34.123.

l D. The following definitions and sections are compatibility Division 4:

The definition of offshore platform radiography in 55 34.3, 34.8, and 34.41(d) as it relates to offshore platform radiography. An Agreement State will need to adopt a definition of platform radiography if it autMrizes such activity on inland waters or tidal waters subject to the State's jurisdiction.

63 l

• O Licensees will have 2 years from the effective date of the rule to affirm that all radiographers have met the certification requirements of .

I34.43(a)(1). This will allow industrial radiography licensees operating in  ;

NRC jurisdiction 2 years to obtain certification for their employees who act

as radiographers. .

l Licensees are required within 60 days of the effective date of the rule 1

! to develop and implement revised procedures needed to implement the final 1 rule. Procedures requiring submittal to the NRC will not need to be submitted i until the next license renewal.

i

, Regarding changes to 571.101, Quality assurance reauirements, providing that 10 CFR Part 34 licensees are no longer required to apply for separate i

approval of their QA program for transport packages provided they meet the j . requirements of 5 34.31(b), or equivalent Agreement State requirements, those

licensees who already have NRC approval of their QA program are deemed to have acceptable procedures. Those licensees without a prior QA program approval

! must develop these procedures before using applicable transport packages.

Licensees are expected to implement any necessary procedural changes into their programs within 60 days of the effective date of the rule, but will not l need to amend their licenses until the next renewal. Expiration dates of any l existing QA program approvals will no longer be valid.

j VI. Finding of No Significant Environmental Impact: Availability l

4

The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR i,

j Part 51, that the rule is not a major Federal action significantly affecting 65 i

0 .

l the quality of the human environment and therefore, an environmental impact statement is not required. .

The revision of 10 CFR Part 34 involves some revisions to regulations authorizing the use of sealed sources in the field of industrial radiography.

1 In particular, the revisions include: upgrades in the testing of  ;

l radiographers, qualifications and duties for radiation safety officers, reductions in inspection frequencies for radiographers and assistants, requirements for periodic testing of the shielding integrity of the radiography device and operability checks of radiation survey equipment, and 1

new recordkeeping and labeling requirements. No requirements for significant I quantities of materials, water, electricity or other forms of energy have been identified, and no environmental or radiation impacts will be involved.

The environmental assessment and finding of no significant impact on which this determination is based are available for inspection at the NRC Public Document Room at 2120 L Street, NW. (Lower Level), Washington DC. )

1 Single copies of the environmental assessment and finding of no significant l impact are available from Dr. Donald 0. Nellis, Radiation Protection and l Health Effects Branch, Division of Regulatory Applications, Office of Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, l telephone (301) 415-6257.

l VII. Paperwork Reduction Act Statement This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1996 (44 U.S.C. 3501 et seq.).

66 l

These requirements were approved by Office of Management and Budget; approval number 3150- . .

The public reporting burden for this collection of information is estimated to average 83 hours9.606481e-4 days <br />0.0231 hours <br />1.372354e-4 weeks <br />3.15815e-5 months <br /> per licensee, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments on any aspect of this collection of information, including suggestions for reducing this burden, to the Information and Records Management. Branch (T-6F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; and to the Desk Officer, Office of Information and Regulatory Affairs, NE0B-10202, (3150- ), Office of Management and Budget, Washington, DC 20503.

! Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

1 VIII. Regulatory Analysis l

The Commission prepared a regulatory analysis on this final rule. The analysis examines the costs and benefits of the alternatives considered by the Commission. See the discussion in the Regulatory Flexibility Certification concerning the final regulatory analysis. This analysis is available for 67

inspection in the NRC Public Document Room at 2120 L Street NW. (Lower Level),

Washington, DC. .

IX. Regulatory Flexibility Certification.

As required by the Regulatory Flexibility Act (5 U.S.C. 605(b), the Commission certifies that this rule does not have a significant adverse economic impact on a substantial number of sm-"  ; ties. The NRC has prepared a final regulatory analysis of the impact of this rule on small entities. A copy of the final regulatory analysis is available for inspection or copying in the NRC Public Document Room, 2120 L Street, NW. (Lower Level)

Washington, DC. The regulation affects about 170 industrial radiography licensees, of which most are small entities. The regulatory analysis for the j final rule shows that there will be an average net savings of $18,000 per licensee per year for most licensees. For those licensees who will need to j hire additional assistants to meet the two-person-requirement, the cost used l in the regulatory analysis was between $5,000 and $53,000 per year..

X. Small Business Regulatory Enforcement Fairness Act l In accordance with the Small Business Regulatory Enforcement Fairness Act l

of 1996, the NRC has determined that this action is not a " major rule", and has submitted this determination to the General Accounting Office and the Congress, as required.

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1 10 CFR Part 150 Hazardous materials-transportation, Intergovernmental relations, Nuclear .

materials, Penalty, Reporting and recordkeeping requirements, Security  !

measures, Source material, Special nuclear material.

For 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. 552 and 553, the NRC is adopting the following amendments.to 10 CFR Parts 30, 34, 71, and 150.

• * * *

• 1 1

I PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF l

BYPRODUCT MATERIAL  ;

1. The authority citation'for Part 30 continues to read as follows:

AUTHORITY:. Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234, 83, Stat. 444, as amended (42 U.S.C. 2111,.2112, 2201, 2232, 2233, 2236, 2282); secs. 201 as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

I Section 30.7 also issued under Pub. L. 95 - 601, sec. 10, 92 Stat. 2951 l as amended by Pub. L. 102 - 486, sec. 2902, 106 Stat. 3123, (42 U.S.C. 5851).

Section 30.34(b) also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

70 mWm -m w ma y < = p --

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XI. Backfit Analysis I -

The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this rule and, therefore, that a backfit analysis is not required for this rule. The final rule does not involve any provisions that impose i backfits as defined in 10 CFR 50.109(a)(1).

i List of Subjects 10 CFR Part 30 I Byproduct material, Criminal penalties, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.

l 10 CFR Part 34 Byproduct material, Criminal penalties, Nuclear material, Packaging and containers, Radiation protection, Radiography, Reporting and recordkeeping requirements, Scientific equipment, Security measures.

10 CFR Part 71 Criminal penalties, Hazardous materials transportation, Nuclear materials, Packaging and containers, Reporting and recordkeeping requirements.

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. . . . . . ~ _ .. .

I 30.4 IAmendedl. '

l 2. In 5 30.4, the definitions of Radioarapher, Radioarapher's assistant, .

l L and Radioaraphy are removed.

l 1 l

3. Part 34 is revised to read as follows: l l

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PART 34--LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION l SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS i

Subpart A - General Provisions

Secs. ,

l 1 I

34.1 Purpose and scope.

l 34.3 Definitions. l l 34.5 Interpretations.

l 34.8 Information collection requirements: OMB approval.

Subpart B - Specific Licensing Provisions

'34.11 Application for a specific license.

34.13 Specific license for industrial radiography.

Subpart C - Equipment l 34.20 Performance requirements for industrial radiography equipment.

l 34.21 Limits on external radiation levels from radiographic exposure devices, storage containers, and source changers.

34.23 Locking of radiographic exposure devices, storage containers, and source changers.

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l 34.25 Radiation survey instruments.

34.27 Leak testing and replacement of sealed sources. .

34.29 Quarterly inventory.

34.31 Inspection and maintenance of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments.

34.33 Permanent radiographic installations.

34.35 Labeling, storage, and transportation.

Subpart D - Radiation Safety Requirements 34.41 Conducting industrial radiographic operations.

34.42 Radiation Safety Officer for industrial radiography.

l 34.43 Training, j 34.45 Operating and emergency procedures.

l 34.46 Supervision of radiographers' assistants.

34.47 Personnel monitoring.

l 34.49 Radiation surveys.

l 34.51 Surveillance.

34.53 Posting.

Subpart E - Recordkeeping Requirements 34.61 Records of tae specific license for industrial radiography.

34.63 Records of the receipt and transfer of sealed sources.

34.65 Records of radiation survey instruments.

34.67 Records of leak testing of sealed sources and devices containing depleted uranium.

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34.69 Records of quarterly inventory.

34.71 Utilization logs. .

34.73 Records of inspection and maintenance of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments.

34.75 Records of alarm system and entrance control checks at permanent radiographic installations.

34.79 Records of training and certification.

34.81 Cop.ies of operating and emergency procedures.

34.83 Records of personnel monitoring procedures.

34.85 Records of radiation surveys.

34.87 Form of records.

34.89 Location of documents and records.

Subpart F - Notifications 34.101 Notifications.

Subpart G - Exemptions 34.111 Applications for exemptions.

Subpart H - Violations 34.121 Violations.

34.123 Criminal penalties.

Appendix A to 10 CFR Part 34 73

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(

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

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

1 Section 34.45 also issued under sec. 206, 88 Stat.1246 (42 U.S.C. 5846). l l

l I Subpart A - General Provisions l

5 34.1 Purpose and scope.

l This part prescribes requirements for the issuance of licenses for the

, use of sealed sources containing byproduct material and radiation safety requirements for persons using these sealed sources in industrial radiography.

The provisions and requirements of this part are in addition to, and not in I substitution for, other requirements of this chapter. In particular, the requirements and provisions of 10 Parts 19, 20, 21, 30, 71, 150, 170, and 171 of this chapter apply to applications and licenses subject to this part. This l rule does not apply to medical uses of byproduct material.

5 34.3 Definitions.

l ALARA (acronym for as low as is reasonably achievable) means making every reasonable effort to maintain exposures to radiation as far below the dose limits specified in 10 CFR Part 20 as is practical consistent with the purpose l for which the licensed activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of j technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, 74

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and in relation to utilization of nuclear energy and licensed materials in the public interest. .

Annual refresher safety training means a review conducted or provided by j the licensee for its employees on radiation safety aspects of industrial radiography. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, new or revised regulations, accidents or errors that have been observed, and should also provide opportunities for employees to ask safety questions.

! Assoc.iated equipment means equipment that is used in conjunction with a radiographic exposure device to make radiographic exposures that drives, l

guides, or comes in contact with the source, (e.g., guide tube, control tube,

, control (drive) cable, removable source stop, "J" tube and collimator when it i

is used as an exposure head.

1 l

Becquerel (Bq) means one disintegration per second.

Certifying Entity means an independent certifying organization meeting the requirements in Appendix A of this part or an Agreement State ma-ting the requirements in Appendix A, Parts II and III of this part.

Co11/mator means a radiation shield that is placed on -d of the guide tube or directly onto a radiographic exposure device to restrict the size of the radiation beam when the sealed source is cranked into position to l

make a radiographic exposure.

Control (drive) cable means the cable that is connected to the source assembly and used to drive the source to and from the exposure location.

Control drive mechanism means a device that enables the source assembly l

l to be moved to and from the exposure device.

l l

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Control tube means a protective sheath for guiding the control cable.

The control tube connects the control drive mechanism to the radiographic .

exposure device.

Exposure head means a device that locates the gamma radiography sealed source in the selected working position. (An exposure head is also known as a source stop.)

Field station means a facility where licensed material may be stored or used and from which equipment is dispatched.

Gray means the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 Joule / kilogram. It is also equal to 100 rads.

Guide tube (Projection sheath) means a flexible or rigid tube (i.e.,

"J" tube) for guiding the source assembly and the attached control cable from the exposure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head.

Hands-on experience means experience in all of those areas considered to be directly involved in the radiography process.

Independent certifying organization means an independent organization that meets all of the criteria of Appendix A to this part.

Industrial radiography (radiography) means an examination of the structure of materials by nondestructive methods, utilizing ionizing radiation to make radiographic images.

Lay-barge radiography means industrial radiography performed on any water vessel used for laying pipe.

Offshore platforia radiography means industrial radiography conducted from a platform over a body of water.

76

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Permanent radiographic installation means an enclosed shielded room, i cell, or vault, not located at a temporary jobsite, in which radiography is .

performed.

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l Practical Examination means a demonstration through practical application of the safety rules and principles in industrial radiography including use of l

i all appropriate equipment and procedures.

1 Radiation Safety Officer for industrial radiography means an individual l

i with the responsibility for the overall radiation safety program on behalf of I the licensee and who meets the requirements of 5 34.42.

Radiographer means any individual who performs or who, in attendance at l the site where the sealed source or sources are being used, personally supervises industrial radiographic operations and who is responsible to the

! licensee for assuring compliance with the requirements of the Commission's I

regulations and the conditions of the license.

Radiographer certification means written approval received from a certifying entity stating that an individual has satisfactorily met certain established radiation safety, testing, and experience criteria.

l Radiographer's assistant means any individual who under the direct l supervision of a radiographer, uses radiographic exposure devices, sealed sources or related handling tools, or radiation survey instruments in j industrial radiography.

Radiographic exposure device (also called a camera, or a projector) means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise l

l changed, from a shielded to unshielded position for purposes of making a radiographic exposure.

I 77

Radiographic operations means all activities associated with the presence of radioactive sources in a radiographic exposure device during use of the .

device or transport (except when being transported by a common or contract transport), to include surveys to confirm the adequacy of boundaries, setting up equipment and any activity inside restricted area boundaries.

S-tube means a tube through which the radioactive source travels when inside a radiographic exposure device.

Sealed source means any byproduct material that is encased in a capsule designed t.o prevent leakage or escape of the byproduct material.

Shielded position means the location within the radiographic exposure device or source changer where the sealed source is secured and restricted from movement.

Sfevert means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor (1 Sv - 100 rems).

Source assembly means an assembly that consists of the sealed source and a connector that attaches the source to the control cable. ~he source assembly may also include a stop ball used to secure the source in the shielded position.

Source changer means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those also used for transporting and storage of sealed sources.

Storage area means any location, facility, or vehicle which is used to store or to secure a radiographic exposure device, a storage container, or a sealed source when it is not in use and which is locked or has a physical 78

l l barrier to prevent accidental exposure, tam;:aring with, or unauthorized l

removal of the device, container, or source. -

Storage container means a container in which sealed sources are secured and stored.

Temporary Johsite means a W nion where radiographic operations are

( conducted and where licensed material may be stored other than those

location (s) of use authorized on the license.

l Underwater radiography means industrial radiography performed when the i radiograph.ic exposure device and/or related equipment are beneath the surface i of the water.

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534.5 Interpretations.

i Except as specifically authorized by the Commission in writing, no l interpretation of the meaning of the regulations in this part by any officer l or employee of the Commission, other than a written interpretation by the General Counsel, will be recognized to be binding upon the Commission.

534.8 Information collection reauirements: OMB approval.

(a) The Nuclear Regulatory Commission has submi'ted the information collection requirements contained in this part to the Office of Management and l Budget (0MB) for approval as required by the Paperwork Reduction Act of 1980 l

l (44 U.S.C. 3501 et seq.) OMB has approved the information collection 1

requirements contained in this part under control number 3150- .

(b) The approved information collection requirements contained in this part appear in il 34.13, 34.20, 34.25, 34.27, 34.29, 34.31, 34.33, 34.35, 4 .

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34.43, 34.45, 34.47, 34.49, 34.61, 34.63, 34.65, 34.67, 34.69, 34.71, 34.73, 34.75, 34.79, 34.81, 34.83, 34.85, 34.87, 34.89, 34.91, and 34.101. .

(c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. The information collection requirement and the control number under which it is approved are as follows:

(1) In 5 34.11, NRC Form 313 is approved under control number 3150-0120.

. Subpart B - Specific Licensing Provisions i34.11 Application for a specific license.

A person may file an application for specific license for use of sealed sources in industrial radiography, in duplicate, on NRC Form 313, " Application for Material License," in accordance with the provisions of 5 30.32 of this chapter.

I i 34.13 Specific license for industrial radiography.

An application for a specific license for the use of licensed material in l

industrial radiography will be approved if the applicant meets the following  ;

1  :

requirements: l 1

(a) The applicant satisfies the general requirements specified in 5 30.33 of this chapter for byproduct material, as appropriate, and any special requirements contained in this part.

(b) The applicant submits an adequate program for training radiographers and radiographers' assistants'that meets the requirements of 5 34.43.

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(1) After (2 years after the final rule is published in the Federal Register), a license applicant need not describe its initial training and .

examination program for radiographers in the subjects outlined in 5 34.43(g). j (2) From (insert effective date of final rule) to (2 years after the final rule is published in the Federal Register) a license applicant may i

affirm that all individuals acting as industrial radiographers will be i certified in radiation safety by a certifying entity before commencing duty as radiographers. This affirmation substitutes for a description of its initial training and examination program for radiographers in the subjects outlined in 5 34.43(g).

(c) The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification 4 of individuals acting as radiographers remains valid.

(d) The applicant submits written operating and emergency procedures as described in 5 34.45.

(e) The applicant submits a description of a program for inspections of the job performance of erth radiographer.and radiographers' assistant at intervals not to exc%d 6 months as described in 5 34.43(e).

(f) The applicant submits a description of the applicant's overall organizational structure as it applies tc the radiation safety responsibilities in industrial radiography, including specified delegation of authority and responsibility.

(g) The applicant identifies and lists the qualifications of the individual (s) designated as the RSO (134.42) and potential designees responsible for ensuring that the licensee's radiation safety program is implemented in accordance with approved procedures.

81 i

i

(h) If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium (DU) shielding, the applicant .

must describe the procedures for performing and the qualifications of the person (s) authorized to do the leak testing. If the applicant intends to analyze its own wipe samples, the application must include a description of the procedures to be followed. The description must include the --

(1) Instruments to be used; (2) Methods of performing the analysis; and (3) . Pertinent experience of the person who will analyze the wipe samples.

(i) If the applicant intends to perform "in-house" calibrations of survey instruments the applicant must describe methods to be used and the relevant experience of the person (s) who will perform the calibrations. All calibrations must be performed according to the procedures described and at I the intervals prescribed in i 34.25.

(j) The applicant identifies and describes the location (s) of all field l stations and permanent radiographic installations.

(k) The applicant identifies the locations where all records required by this part and other parts of this Chapter will be maintained.

l 1

Subpart C - Equipment i 34.20 Performance reauirements for industrial radiography eauiDment.

Equipment used in industrial radiographic operations must meet the l following minimum criteria:

l l

82

1 (a) Each radiographic exposure device, source assembly or sealed source, and all associated equipment must meet the requirements specified in American .

National Standard Institute, N432-1980 " Radiological Safety for the Design and  !

l Construction of Apparatus for Gamma Radiography," (published as NBS Handbook i 136, issued January 1981). This publication has been approved for 1

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 J

American National Standards Institute, Inc.,1430 Broadway, New York, New York 10018 Telephone (212)-642-4900. Copies of the document are available for inspection at the Nuclear Regulatory Commission Library,11545 Rockville Pike, Rockville, Maryland 20852. A copy of the document is also on file at the Office of the Federal Register, 800 North Capital Street NW., Suite 700, 1

Washington, DC 20408.

~

Engineering analysis may be submitted by an i.pplicant or licensee to demonstrate the applicability of previously performed testing on similar individual radiography equipment components. Upon review, the Commission may-find this an acceptable alternative to actual testing of the component pursuant to the above referenced standard.

(b) In addition to the requirements specified in paragraph (a) of this section, the following requirements apply to radiographic exposure devices, source changers, source assemblies and sealed sources.

(1) The licensee shall ensure that each radiographic' exposure device has attached to it a durable, legible, clearly visible label bearing the --

(i) Chemical symbol and mass number of the radionuclide in the device; (ii) Activity and the date on which this activity was last measured; (iii) Model (or product code) and serial number of the sealed source; 83

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

(iv) Manufacturer's identity of the sealed source; and (v) Licensee'_s name, address, and telephone number. .

l (2) Radiographic exposure devices intended for use as Type B transport

! containers must meet the applicable requirements of 10 CFR Part 71.

(3) Modification of radiographic exposure devices, source changers, and source assemblies 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)

L of this section, the following requirements apply to radiographic exposure devices, source assemblies, and associated equipment that allow the source to be moved out of the device for radiographic operations or to source changers.

(1) The coupling between the source assembly and the control cable must l be designed in such a manner that the source assembly will not become j disconnected if cranked outside the guide tube. The coupling must be such i that it cannot be unintentionally disconnected under normal and reasonaMy l

l foreseeable abnormal conditions.

(2) The device must automatically secure the source assembly when it is cranked back ir.to the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the i exposure device.

(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.

t 84

(4) (i) Each sealed source or source assembly must have attached to it or engraved on it, a durable, legible, visible label with the words: .

l " DANGER -- RADI0 ACTIVE."

(ii) The label may not interfere with the safe operation of the exposure device or associated equipment.  !

(5) The guide tube must be able to withstand a crushing test that l l closely approximates the crushing forces that are likely to be encountered l l during use, a' be able to withstand a kinking resistance test that closely )

approximates the kinking forces that are likely to be encountered during use, l

l (6) Guide tubes must be used when moving the source out of the device.

(7) An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during industrial radiography operations.

, (8) The guide tube exposure head connection must be able to withstand l the tensile test for control units specified in ANSI N432-1980.

(9) Source changers must provide a system for ensuring that the source l will not be accidentally withdrawn from the changer when connecting or l

L disconnecting the drive cable to or from a source assembly.

(d) All radiographic exposure devices and associated equipment in use after January 10, 1996, must comply with the requirements of this section.

(e) Notwithstanding paragraph (a)(1) of this section, equipment used in industrial radiographic operations need not comply with 5 8.9.2(c) of the j Endurance Test in American National Standards Institute N432-1980, if the prototype equipment has been tested using a torque value representative of the i torque that an individual using the radiography equipment can realistically i exert on the lever or crankshaft of the drive mechanism.

85 l

I 34.21: Limits on external radiation levels from storage containers and source chanaers. .

The maximum exposure rate limits for storage containers and source changers are 2 millisieverts (200 millirem) per hour at any exterior surface, and 0.1 millisieverts (10 millirem) per hour at 1 meter from any exterior surface with the sealed source in the shielded position.

I 34.23: Lockina of radioaraphic exposure devices storaae containers and source chanaers.

(a) Each radiographic exposure device must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The exposure device and/or its container must be kept locked (and if a keyed-lock, with the key removed at all times) when not under the direct surveillance of a radiographer or a radiographer's assistant except at permanent radiographic installations as stated in 5 34.51. l In addition, during radiographic operations the sealed source assembly must be secured in the shielded position each time the source is returned to that l position.

j (b) Each sealed source storage container and source changer must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. Storage containers and source changers must be kept locked (and if a keyed-lock, with the key removed at all times) when containing sealed sources except when under the direct surveillance of a radiographer or a radiographer's assistant.

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4 5 34.25: Radiation survey instruments.

(a) The licensee shall keep sufficient calibrated and operable radiation .

survey instruments at each location where radioactive material is present to make the radiation surveys rev & ad by this part and by 10 CFR Part 20 of this chapter. Instrumentation required by this section must be capable of measuring a range from 0.02 millisieverts (2 millirems) per hour through 0.01 sievert (1 rem) per hour.

l (b) The licensee shall have each radiation survey instrument required under paragraph (a) of this section calibrated --

(1) At intervals not to exceed 6 months and after instrument servicing, except for battery changes; (2) For linear scale instruments, at two points located approximately one-third and two-thirds of full-scale on each scale; for logarithmic scale instruments, at mid-range of each decade, and at two points of at least one l

decade; and for digital instruments, at 3 points between 0.02 and 10 millisieverts (2 and 1000 millirems) per hour; and (3) So that an accuracy within plus or minus 20 percent of the calibration source can be demonstrated at each point checked.

(c) The licensee shall maintain records of the results of the instrument calibrations in accordance with 5 34.65.

5 34.27 Leak testina and replacement of sealed sources.

(a) The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing of any sealed source must be performed by persons authorized to do so by the NRC or an Agreement State.

87

4 (b) The opening, repair, or modification of any sealed source rrst be performed by persons specifically authorized to do so by the Commission or an .

Agreement State.

(c) Testing and recordkeeping requirements.

(1) Each licensee who uses a sealed source shall have the source tested for leakage at intervals not to exceed 6 months. The leak testing of the source must be performed using a method approved by the Commission or by an Agreement State. The wipe sample should be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of 185 Bq (0.005 microcurie) of radioactive material on the test sample and must be performed by a person specifically authorized by the Commission or an Agreement State to perform the analysis.

(2) The licensee shall maintain records of the leak tests in accordance with 5 34.67.

(3) Unless a sealed source is accompanied by a certificate from the transferor that shows that it has been leak tested within 6 months before the transfer, it may not be used by the licensee until tested for leakage. Sealed sources that are in storage and not in use do not require leak testing, but must be tested before use or transfer to another person if the interval of storage exceeds 6 months.

(d) Any test conducted pursuant to paragraphs (b) and (c) of this section which reveals the presence of 185 Bq (0.005 microcurie) or more of removable radioactive material must be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall have it decontaminated and repaired or disposed of 88

in accordance with Commission regulations. A report must be filed with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory .

Commission, Washington, DC 20555-0001, within 5 days of any test with results that exceed the threshold in this subsection, describing the equipment involved, the test results, and the corrective action taken. A copy of the report must be sent to the Administrator of the appropriate Nuclear Regulatory Commission's Regional Office listed in Appendix D of 10 CFR Part 20 of.this l

chapter " Standards for Protection Against Radiation." i l

(e) Each exposure device using depleted uranium (DU) shielding and an )

"S" tube configuration must be tested for DU contamination at intervals not to exceed 12 months. The analysis must be capable of detecting the presence of i

. 185 Bq (0.005 microcuries) of radioactive material on the test sample and must be performed by a person specifically authorized by the Commission or an Agreement State to perform the analysis. Should such testing reveal the presence of DU contamination, the exposure device must be removed from use until an evaluation of the wear of the S-tube has been made. Should the evaluation reveal that the S-tube is worn through, the device may not be used again. DU shielded devices do not have to be tested for DU contamination while in storage and not in use. Before using or transferring such a device 1

however the device must be tested for DU contamination, if the interval of storage exceeds 12 months. A record of the DU leak-test must be made in accordance with 5 34.67.

. 89 l

l 5 34.29 Quarterly inventory.

(a) Each licensee shall conduct a quarterly physical inventory to .

account for all sealed sources and for devices containing depleted uranium received and possessed under this license.

(b) The licensee shall maintain records of the quarterly inventory in '

accordance with 5 34.69.

5 34.31 Inspection and maintenance of radioaraphic exposure devices.

I transport and storaae containers associated eauipment. source chanaers and survey instruments. '

(a) The licensee shall perform visual and operability checks on survey l

meters, radiographic exposure devices, transport and storage containers, associated equipment and source changers before use on each day the equipment is to be used to ensure that the equipment is in good working condition, that j the sources are adequately shielded, and that required labeling is present.

Survey instrument operability must be performed using check sources or other appropriate means. If equipment problems are found, the equipment must be

! removed from service until repaired.

(b) Each licensee shall have written procedures for:

(1) Inspection and routine maintenance of radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments at intervals not to exceed 3 months or before the first use thereafter to ensure the proper functioning of components important to safety.

Replacement components shall meet design specifications. If equipment problems are found, the equipment must be removed from service until repaired.

90 I

l-(2) Inspection and maintenance necessary to maintain the Type B packaging used to transport radioactive materials. The inspection and .

maintenance program must include procedures to assure that' Type B packages are shipped and maintained in accordance with the certificate of compliance or other approval.

(c) Records of equipment problems and of any maintenance performed under paragraphs (a) and (b) of this section must be made in accordance with 5 34.73.

1 34.33 Permanent radioaraphic installations.

(a) Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation must have either:

(1) An entrance control of the type described in i 20.1601(a)(1) of this chapter that reduces the radiation level upon entry into the area, or (2) Both conspicuous visible and audible warning signals to warn of the presence of radiation. The visible signal must be actuated by radiation whenever the source is exposed. The audible signal must be actuated wlmn an attempt is made to enter the installation while the source is exposed.

(b) The alarm system must be tested for proper operation with a radiation source each day before the installation is used for radiographic operations. The test must include a check of both the visible and audible signals. Entrance control devices that reduce the radiation level upon entry (designated in paragraph (a)(1) of this section) must be tested monthly. If an entrance control device or an alarm is operating improperly, it must be l immediately labeled as defective and repaired within 7 calendar days. The I

i facility may continue to be used during this 7-day period, provided the

! 91

licensee implements the continuous surveillance requirements of 5 34.51 and uses an alarming ratemeter. Test records for entrance controls and audible .

and visual alarm must be maintained in accordance with 5 34.75.

I34.35 Labelina, storaae, and transportation.

(a) The licensee may not use a source changer or a container to store licensed material unless the source changer or the storage container has securely attached to it a durable, legible, and clearly visible label bearing the standard trefoil radiation caution symbol conventional colors, i.e.,

magenta, purple or black on a yellow background, having a minimum diameter of 25 mm, and the wording CAUTION

• RADI0 ACTIVE MATERIAL NOTIFY CIVIL AUTHORITIES (or " NAME OF COMPANY")

• --- or " DANGER" (b) The licensee may not transport licensed material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with regulations set out in 10 CFR Part 71.

(c) Locked radiographic exposure devices and storage containers must be physically secured to prevent tampering or removal by unauthorized personnel.

The licensee shall store licensed material in a manner which will minimize danger from explosion or fire.

(d) The licensee shall lock and physically secure the transport package containing licensed material in the transporting vehicle to prevent accidental l

92 1

. o loss, tampering, or unauthorized removal of the licensed material from the vehicle.

• Subpart D - Radiation Safety Requirements i 34.41 Conductina industrial radicaraphic operations.

(a) Whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by i

at least one other qualified radiographer or an individual who has at a minimum met the requirements of 5 34.43(c). The additional qualified individual shall observe the operations and be capable of providing immediate assistance to prevent unauthorized entry. Radiography may not be performed if only one qualified individual is present.

(b) All radiographic operations conducted at locations of use authorized on the license must be conducted in a permanent radiographic installation, unless specifically authorized by the Commission.

(c) A licensee may conduct lay-barge, offshore platform, or underwater radiography only if procedures have been approved by the Commission or by an Agreement State. i j i 34.42 Radiation Safety Officer for industrial radioaraphy.

The RSO shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's program.

(a) The minimum qualifications, training, and experience for RS0s for

industrial radiography are as follows

(1) Completion of the training and testing requirements of 5 34.43(a);

)

93

(2) 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> of hands-on experience as a qualified radiographer in industrial radiographic operations; and .

(3) Formal training in the establishment and maintenance of a radiation protection program.

(b) The Commission will consider alternatives when the RS0 has appropriate training and/or experience in the field of ionizing radiation, and in addition, has adequate formal training with respect to the establishment and maintenance of a radiation safety protection program.

(c) The specific duties and authorities of the RSO include, but are not limited to:

(1) Establishing and overseeing all operating, emergency, and ALARA procedures as required by 10 CFR Part 20 of this chapter, and reviewing them regularly to ensure that the procedures in use conform to current 10 CFR Part 20 procedures, conform to other NRC regulations and to the license conditions.

(2) Overseeing and approving all phases of the training program for radiographic personnel, ensuring that appropriate and effective radiation protection practices are taught; (3) Ensuring that required radiation surveys and leak tests are performed and documented in accordance with the regulations, including any corrective measures when levels of radiation exceed established limits; (4) Ensuring that personnel monitoring devices are calibrated and used properly by occupationally-exposed personnel, that records are kept of the monitoring results, and that timely notifications are made as required by 520.2203 of this chapter; and 94

1 (5) Ensuring that operations are conducted safely and to assume control for instituting corrective actions including stopping of operations when . i necessary.  ;

i (d) Licensees will have 2 years from the effective date of this rule to meet the requirements of paragraph (a) or (b) of this section.  !

I l

5 34.43 Training.

(a) The licensee may not permit any individual to act as a radiographer until the . individual --

(1) Has received training in the subjects in paragraph (g) of this section, in addition to a minimum of 2 months of on-the-Job training, and is certified through a radiographer certification program by a certifying entity in accordance with the criteria specified in Appendix A of this part. (An independent organization that would like to be recognized as a certifying entity shall submit its request to the Director, Office of Nuclear Materials Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC.

20555-0001.)

OR (2) The licensee may, until (insert date 2 years after the final rule is published in the Federal Register), allow an individual who has not met the requirement of paragraph (a)(1) of this section, to act as a radiographer after the individual has received training in the subjects outlined in paragraph (g) of this section and demonstrated an understanding of these subjects by successful completion of a written examination that was previously submitted to and approved by the Commission.

95

(b) In addition, the licensee may not permit any individual to act as a radiographer until the individual - - .

4 (1) Has received copies of and instruction in the requirements described in NRC regulations contained in this part; in il 30.7, 30.9, and 30.10 of this chapter; in the applicable sections of 10 CFR Parts 19 and 20, of this I

chapter, in applicable DOT regulations as referenced in 10 CFR Part 71, in the NRC license (s) under which the radiographer will perform industrial radiography, and the licensee's operating and emergency procedures; (2) .Has demonstrated understanding of the licensee's license and operating and emergency procedures by successful completion of a written or oral examination covering this material.

(3) Has received training in the use of the licensee's radiographic exposure devices, sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments.

(4) Has demonstrated understanding of the use of radiographic exposure devices, sources, survey instruments and associated equipment described in paragraphs (b)(1) and (b)(3) of this section by successful completion of a

practical examinatian covering this material.

(c) The licensee may not permit any individual to act as a radiographer's assistant until the individual- -

(1) Has received copies of and instruction in the requirements described in NRC regulations contained in this part, in il 30.7, 30.9, and 30.10 of this chapter, in the applicable sections of 10 CFR Parts 19 and 20 of this chapter, in applicable DOT regulations as referenced in 10 CFR Part 71, in the NRC license (s) under which the radiographer's assistant will perform industrial radiography, and the licensee's operating and emergency procedures; 96 m .-- - , , , - - - - - ,,

[

(2) Has developed competence to use, under the personal supervision of the radiographer, the radiographic exposure devices, sealed sources, .

associated equipment, and radiation survey instruments that the assistant will use; and (3) Has demonstrated understanding of the instructions provided under t

(c)(1) of this section by successfully completing a written test on the l

l subjects covered and has demonstrated competence in the use of hardware described in (c)(2) of this section by successful completion of a practical

! examination on the use of such hardware.

(d) The licensee shall provide at.ual refresher safety training for each radiographer and radiographer's assistant at intervals not to exceed i

12 months.

(e) Except as provided in paragraph (e)(4), the RS0 or designee shall conduct an inspection program of the job performance of each radiographer and l l i radiographer's assistant to ensure that the Commission's regulations, license reqairements, and the applicant's operating and emergency procedures are followed. The inspection program must:

(1) Include observation of the performance of each radiographer and radiographer's assistant during an actual industrial radiographic operation, at intervals not to exceed 6 months; and (2) Provide that, if a radiographer or a radiograpier's assistant has not participated in an industrial radiographic operation for more than 6 months since the last inspection, the radiographor must demonstrate knowledge of the training requirements of 5 34.43(b)(3) and the radiographer's assistant l

l must re-demonstrate knowledge of the training requirements of 5 34.43(c)(2) by 1

97 i

I l a practical examination before these individuals can next participate in a radiographic operation. .

4 (3) The Commission may consider alternatives in those situations where i, the individual serves as both radiographer and RSO.

j (4) In those operations where a single individual serves as both j radiographer and RSO, and performs all radiography operations, an inspection program is not required.

l (f) The licensee shall maintain records of the above training to include i

certificat. ion documents, written and practical examinations, refresher safety 1

training and inspections of job performance in accordance with i 34.79.

{ (g) The licensee shall include the following subjects required in s

! paragraph (a) of this section:

i 2

(1) Fundamentals of radiation safety including -- l

} (i) Characteristics of gamma radiation; i^

(ii) Units of radiation dose and quantity of radioactivity;

-(iii) Hazards of exposure to radiation; (iv) Levels of radiation from licensed material; and (v) Methods of controlling radiation dose (time, distance, and shielding);

(2) Radiation detection instruments including --

(i) Use, operation, calibration, and limitations of radiation survey )

instruments; (ii) Survey techniques; and (iii) Use of personnel monitoring equipment; (3) Equipment to be used including --

98

(1) Operation and control of radiographic exposure equipment, remote handling equipment, and storage containers, including pictures or models of .

j source assemblies (pigtails). 1 (ii) Storage, control, and disposal of licensed material; and (iii) Inspection and maintenance of equipment. I l

(4) The requirements of pertinent Federal regulations; and

(5) Case histories of accidents in radiography.

(h) Licensees will have one year from the effective date of this rule to

comply with the additional training requirements specified in paragraphs i

e (b)(1) and (c)(1) of this section.

f 34.45 Operatina and emergency procedures.

l 4

(a) Operating and emergency procedures must include, as a minimum, 4

instructions in the following:

(1) Appropriate handling and use of licensed sealed sources and 4

radiographic exposure devices so that no person is likely to be exposed to l

3 radiation doses in excess of the limits established in 10 CFR Part 20 of this i chapter " Standards for Protection Against Radiation",

(2) Methods and occasions for conducting radiation surveys; j (3) Methods for controlling access to radiographic areas;

! (4) Methods and occasions for locking and securing radiographic exposure r

devices, transport and storage containers and sealed sources; 1-

!- (5) Personnel monitoring and the use of personnel monitoring equipeent; (6) Transporting sealed sources to field locations, including packing of radiographic exposure devices and storage containers in the vehicles,

, 99 f

i

_m... _ _ _ . . _ . _ . - _ _ _ _ _ _ _ _ ..___ _._ . _ _ . _ _ . _ . _ . - _ _ _ - _ . _ . .

i h

placarding of vehicles when needed, and control of the sealed sources during j transportation (refer to 49 CFR Parts 171-173); .

(7) The inspection, maintenance, and operability checks of radiographic exposure devices, survey instruments, transport containers, and storage j containers; j (8) Steps that must be taken immediately by radiography personnel in the i

event a pocket dosimeter is found to be off-scale or an alarm ratemeter alarms i

unexpectedly.

(9) The procedure (s) for identifying and reporting defects and j noncompliance, as required by 10 CFR Part 21 of this chapter; i (10) The procedure for notifying proper persons in the event of an i

accident;

! (11) Minimizing exposure of persons in the event of an accident;

(12) Source recovery procedure if licensee will perform source recovery; i-l (13) Maintenance of records.

l (b) The licensee shall maintain copies of current operating and i emergency procedures in accordance with 5 34.81 and i 34.89.

i t

i

! l 34.46 Supervision of radicaraphers' assistants.

1 Whenever a radiographer's assistant uses radiographic exposure devices,

! associated equipment or sealed sources or conducts radiation surveys required by i 34.49(b) to determine that the sealed source has returned to the shielded position after an exposure, the assistant shall be under the personal supervision of a radiographer. The personal supervision must include: '

(a) The radiogiapher's physical presence at the site where the sealed i

3 sources are being used;

100 i

i-d

i (b) The availability of the radiographer to give immediate assistance if required; and .

(c) The radiographer's direct observation of the assistant's performance of the operations referred to in this section.

5 34.47 Personnel monitorina.

(a) The licensee may not permit any individual to act as a radiographer or a radiographer's assistant unless, at all times during radiographic operations., each individual wears, on the trunk of the body, a combination of direct reading dosimeter, an operating alarm ratemeter, and either a film badge or a TLD. At permanent radiography installations where other appropriate alarming or warning devices are in routine use, the wearing of an alarming ratemeter is not required.

(1) Pocket dosimeters must have a range from zero to 2 millisieverts (200 millirems) and must be recharged at the start of each shift. Electronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters.

(2) Each film badge and TLD must be assigned to and worn by only one individual.

(3) Film badges must be replaced at periods not to exceed one month and TLDs must be replaced at periods not to exceed three months.

(4) After replacement, each film badge or TLD must be processed as soon as possible.

(b) Direct reading dosimeters such as pocket dosimeters or electronic personal dosimeters, must be read and the ex)osures recorded at the beginning f

l 101

and end of each shift, and records must be maintained in accordance with 534.83.  ; .

(c) Pocket dosimeters, or electronic personal dosimeters, must be checked at periods not to exceed 12 months for correct response to radiation, and records must be maiatained in accordance with .134.85. Acceptable dosimeters must read within plus or minus 20 percer.t of the true radiation exposure.

(d) If an individual's pocket dosimeter is found to be off-scale, or if his or her, electronic personal dosimeter reads greater than 2 millisieverts (200 millirems), and the possibility of radiation exposure cannot be ruled out as the cause, the individual's film badge or TLD must be sent for processing within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. In addition, the individual may not resume work associated with licensed material use until a determination of the individual's radiation '

exposure has been made. This determination must be made by the RS0 or the RS0's designee. The results of this determination must be included in the records maintained in accordance with 5 34.83.

(e) If a film badge or TLD is lost or damaged, the worker shall cease work immediately until a replacement film badge or TLD is provided and the exposure is calculated for the time period from issuance to loss or damage of the film badge or TLD. The results of the calculated exposure and the time period for which the film badge or TLD was lost or damaged must be included in the records maintained in accordance with 5 34.83.

(f) Reports received from the film badge or TLD processor must be retained in accordance with 5 34.83.

(g) Each alarm ratemeter must --

102

. . l (1) Be' checked to ensure that the alarm functions properly (sounds) before using at the start of each shift; .

(2) Be set to give an alarm signal at a preset dose rate of 5 mSv/hr l i

(500 mrem /hr); with an accuracy of plus or minus 20 percent of the true

. radiation dose rate; (3) Require special means to change the preset alarm function; and (4) Be calibrated at periods not to exceed 12 months for correct response to radiation. The licensee shall maintain records of alarm ratemeter calibrations in accordance with 5 34.83.

t l

l 534.49 Radiation surveys.

.The licensee shall:

(a) Conduct surveys with a calibrated and operable radiation survey instrument that meets the requirements of 5 34.25.

l (b) Using a survey instrument meeting the requirements of paragraph (a) l l of this section, conduct a survey of the radiographic exposure device and the i

l guide tube after each exposure when approaching the device or the guide tube.

The survey must determine that the sealed source has returned to its shielded position before exchanging films, repositioning the exposure head, or dismantling equipment.

(c) Conduct a survey of the radiographic exposure device with a calibrated radiation survey instrument any time the source is exchanged and whenever a radiographic exposure device is placed in a storage area (as l

l defined in i 34.3), to ensure that the sealed source is in its shielded position.

(

l (d) Maintain records in accordance with 5 34.85.

103 l

134.51 Surveillance.

During each radiographic operation the radiographer, or the other .-

individual present, as required by 5 34.41, shall maintain continuous direct visual surveillance of the operation to protect against unauthorized entry l into a high radiation area, as defined in 10 CFR Part 20 of this chapter, except at permanent -radiographic installations where all entryways are locked and the requirements of 5 34.33 are met. <

l34.53 Postina.

All areas in which industrial radiography is being performed must be conspicuously posted as required by 1 20.1902 of this. chapter. Exceptions listed in i 20.1903 of this chapter do not apply to industrial radiographic operations.

Subpart E - Recordkeeping Requirements 634.61 Records of the specific license for industrial radioaraphy.

Each licensee shall maintain a copy of its license, license conditions,

- documents incorporated by reference, and amendments to each of these items until superseded by new documents approved by the commission, or until the  :

Commission terminates the license. ,

I34.63 Records of receipt and transfer of sealed sources.

(a) Each licensee shall maintain records showing the receipts and transfers of sealed sources and devices using DU for shielding and retain each "

record for 3 years after it is made.

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(b) These records must include the date, the name of the individual making the record, radionuclide, number of becquerels (curies) or mass (for .

DU), and manufacturer, model, and serial number of each sealed source and/or device, as appropriate.

I 34.65 Records of radiation survey instruments.

Each licensee shall maintain records of the calibrations of its radiation surve) nstruments that are required under i 34.25 and retain each record for ,

3 years after it is made.

S 34.67 Records of leak testina of sealed sources and devices containina depleted uranium.

I Each licensee shall maintain records of leak test results for sealed sources and for devices containing DU. The results must be stated in units of becquerels (microcuries). The licensee shall ratain each record for 3 years l after it is made or until the source in storage is removed.

l 5 34.69 Records of auarterly inventory.

l. (a) Each licensee shall maintain records of the quarterly inventory of

• sealed sources and of devices containing depleted uranium as required by l 5 34.29 and retain each record for 3 years after it is made.

(b) The record must include the date of the inventory, name of-the individual conducting the inventory, radionuclide, number of becquerels (curies) or mass (for DU) in each device, location of sealed source and/or devices, and manufacturer, model, and serial number of each sealed source and/or device, as appropriate.

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I 34.71 Utilization loas.

L (a) Each licensee shall maintain utilization legs showing for each .

sealed source the following information:

(1) A description, including the make, model, and serial number of the l

L radiographic exposure device or transport or :torage container in which the sealed source is located; (2) The identity and signature of the radiographer to whom assigned; and l (3) The plant or site where used and dates of use, including the dates removed and returned to storage.

(b) The licensee shall retain the logs required by paragraph (a) of this section for 3 years after the log is made.

l 5 34.73 Records of inspection and maintenance of radiographic exposure devices, transport and storaae containers. associated eouipment, source chanaers, and survey instruments.

(a) ~Each licensee shall maintain records specified in i 34.31 of equipment problems found in daily checks and quarterly inspections of radiographic exposure devices,-transport and storage containers, associated equipment, source changers, and survey instruments; and retain each record for 3 years after it is made.

(b) The record must include the date of check or inspection, name of inspector, equipment involved, any problems found, and what repair and/or maintenance, if any, was done.

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l 5 34.75 Records of alarm system and entrance control checks at permanent radioarachic installations. .

l j Each licensee shall maintain records of alarm system and entrance control device tests required under i 34.33 and retain each record for 3 years after

! it is made.

l 5 34.79 Records of trainina and certification.

Each licensee shall maintain the following records (of training and certification) for 3 years after the record is made:

l (a) Records of training of each radiographer and each radiographer's assistant.. The record must include radiographer certification documents and l

l veritication of certification status, copies of written tests, dates of oral

. and practical examinations, and names of individuals conducting and receiving the oral and practical examinations; and l (b) Records of annual refresher safety training and semi-annual inspections of job performance for each radiographer and each radiographer's l assistant. The records must list the topics discussed during the refresher

safety training, .the dates the annual refresher safety training was conducted, and names of the instructors and attendees. For inspections of job performance, the records must also include a list showing the items checked and any non-compliances observed by the RSO.

I34.81 Copies of operatino and emeraenc_y procedures.

Each licensee shall maintain a copy of current operating and emergency l

! procedures until the Commission terminates the license. Superseded material l.

must be retained for 3 years after the change is made.

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S 34.83 Records of personnel monitorino.

Each licensee shall maintain the following exposure records specified in .

5 34.47: 1 (a) Direct reading dosimeter readings and yearly operability checks required by 5 34.47(b) and (c) for 3 years after the record is made.

(b) Records of alarm ratemeter calibrations for 3 years after the record is made. 1 (c) Reports received from the film badge or TLD processor until the Commission. terminates the license. l (d) Records of estimates of exposures as a result of: off-scale personal direct reading dosimeters, or lost or damaged film badges or TLDs, until the l Commission terminates the license.

i 34.85 Records of radiation surveys.

l Each licensee shall maintain a record of each exposure device survey 4 conducted before the device is placed in storage as specified in 5 34.49(c),

if that survey is the last one performed in the workday. Each record must be maintained for 3 years after it is made.

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& 34.87 Form of records.

Each record required by this part must be legible throughout the l specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear l

copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and 108

complete records during the required retention period. Recordr, such as I letters, drawings, and specifications, must include all pertinent information, .

such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

534.89 Location of documents and records.

(a) Each licensee shall maintain copies of records required by this part and other applicable parts of this chapter at the location specified in 534.13(k).

(b) Each licensee shall also maintain copies of the following documents and records sufficient to demonstrate compliance at each applicable field station and each temporary jobsite; i

(1) The license authorizing the ute of licensed material; (2) A copy of 10 CFR Parts 19, 20, and 34 of NRC regulations; l (3) Utilization records for each radiographic exposure device dispatched from that location as required by 5 34.71.

(4) Records of equipment problems identified in daily checks of equipment as required by 5 34.73(a);

(5) Records of alarm system and entrance control checks required by i 34.75, if applicable; l (6) Records of direct reading dosimeters such as pocket dosimeter and/or l electronic personal dosimeters readings as required by 5 34.83; (7) Operating and emergency procedures required by 5 34.81; (8) Evidence of the latest calibration of the radiation survey l instruments in use at the site, as required by 5 34.65; d

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(9) Evidence of the latest calibrations of alarm ratemeters and operability checks of pocket dosimeters and/or electronic personal dosimeters .

as required by 5 34.83; (10) Latest survey records required by 5 34.85; (11) The shipping papers for the transportation of radioactive materials required by 5 71.5 of this chapter; and (12) When operating under reciprocity pursuant to i 150.20 of this chapter, a copy of the Agreement State license authorizing the use of licensed l

materials.

l Subpart F - Notifications i

l 5 34.101 Notifications.

i (a) In addition to the reporting requirements specified in i 30.50 and l under other sections of this chapter, such as i 21.21, each licensee shall provide a written report to the U.S. Nuclear Regulatory Commission, Division of Industrial and Medical Nuclear Safety, Washington, DC 20555-0001, with a l copy to the Director, Office for Analysis and Evaluation of Operational Data, l

U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, within 30 days of the occurrence of any of the following incidents involving radiographic equipment:

l (1) Unintentional disconnection of the source assembly from the control cable; (2) Inability to retract the source assembly to its fully shielded l

l position and secure it in this position; or i (3) Failure of any component (critical to safe operation of the device) to properly perform its intended function; j 110 l

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(b) The licensee shall include the following information in each report j suomitted under paragraph (a) of this section, and in each report of .

overexposure submitted under 10 CFR 20.2203 which involves failure of safety components of radiography equipment:

(1) A description of the equipment problem; (2) Cause of each incident, if known; (3) Name of the manufacturer and model number of equipment involved in the incident; (4) . Place, date, and time of the incident; (5) Actions taken to establish normal operations; j (6) Corrective actions taken or planned to prevent recurrence; and l

l (7) Qualifications of personnel involved in the incident.

(c) Any licensee conducting radiographic operations or storing l radioactive material at any location not listed on the license for a period in excess of 180 days in a calendar year, shall notify the appropriate NRC regional office listed in 5 30.6(a)(2) prior to exceeding the 180 days.

Subpart G - Exemptions 5 34.111 Applications for exemptions.

The Commission may, upon application of any interested person or upon its own initiative, grant an exemption from the requirements of the regulations in l this part if it determines the exemption is authorized by law and would not i

endanger life or property or the comon defense and security and is otherwise in the public interest.

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Subpart H - Violations 6 34.121 Violations. .

(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of ---

(1) The Atomu Energy Act of 1954, as amended; (2) Title II of the Energy Reorganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to these Acts.

(b) The Commission may obtain a court order for the payment of a civil penalty imposed under Section 234 of the Atomic Energy Act; (1) For violations of ---

(i) Sections 53, 57, 62, 63, 81, 82,101,103,104,107, or 109 of the l

Atomic Energy Act of 1954, as amended; i

(ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or order issued pursuant to the sections l specified in paragraph (b)(1)(1) of this section.

l (iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section.

(2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954, as amended.

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5 34.123 Criminal penalties.

, (a) Section 223 of the Atomic Energy Act of 1952, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under one or more of El 161b, 1611, or 1610 of the Act. For purposes of Section 223, all the regulations in 112

l 10 CFR Part 34 are issued under one or more of 15161b,1611, or 1610, except for the sections listed in paragraph (b) of this section. .

(b) The regulations in 10 CFR Part 34 that are not issued under sections 161b, 1611, or 1610 for the purposes of Section 223 are as follows: il 34.1, 34.3, 34.5, 34.8, 34.11, 34.13, 34.111, 34.121, 34.123.

Appendix A to 10 CFR Part 34 1

1. Requirements for an Independent Certifying Organization. l An independent certifying organization shall:

1. Be an organization such as a society or ar.sociation, whose members l l

participate in, or have an interest in, the fields of industrial radiography; )

2. Make its membership available to the general public nationwide that l 1s not restricted because of race, color, religion, sex, age, national origin 1

or disability;

3. Have a certification program open to nonmembers, as well as members;

4. Be an incorporated, nationally recognized organization, that is involved in setting national standards of practice within its fields of expertise;

5. Have an adequate staff, a viable system for financing its operations, and a policy- and decision-making review board;

6. Have a set of written organizational by-laws and policies that provide adequate assurance of lack of conflict of interest and a system for monitoring and enforcing those by-laws and policies;

7. Have a committee, whose members can carry out their responsibilities impartially, to review and approve the certification guidelines and 113 i

l procedures, and to advise the organization's staff in implementing the certification program; . I

8. Have a committee, whose members can carry out their responsibilities impartially, to review complaints against certified individuals and to  !

determine appropriate sanctions; l

l 9. Have written procedures describing all aspects of its certification  !

l program, maintain records of the current status of each individual's l 1

l certification and the administration of its certification program;

10. Have procedures to ensure that certified individuals are provided due process with respect to the administration of its certification program, including the process of becoming certified and any sanctions imposed against certified individuals; l

l 11. Have procedures for proctoring examinations, including qualifications for proctors. These procedures must ensure that the

! individuals proctoring each examination are not employed by the same company l

or corporation (or a wholly-owned subsidiary of such company or corporation) as any of the examinees; l 12. Exchange information about certified individuals with the Commission and other independent certifying organizations and/or Agreement States and allow periodic review of its certification program and related records; and

! 13. Provide a description to the Commission of its procedures for choosing examination sites and for providing an appropriate examination environment.

l II. Requirements for Certification Programs.

All certification programs must:

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l 1. Require applicants for certification to (a) receive training in the topics set forth in i 34.43(g) or equivalent Agreement State regulations, and .

l (b) satisfactorily complete a written examination covering these topics; l 2. Require applicants for certification to provide documentation that demonstrates that the applicant has: (a) received training in the topics set forth in 5 34.43(g) or equivalent Agreement State regulations; l (b) satisfactorily completed a minimum period of on-the-job training; and (c) has received verification by an Agreement State or a NRC licensee that the applicant has demonstrated the capability of independently working as a radiographer;

3. Include procedures to ensure that all examination questions are protected from disclosure;

4. Include procedures for denying an application, revoking, suspending, l

and reinstating a certificate;

5. Provide a certification period of not less than 3 years nor more than l

5 years; j 6. Include procedures for renewing certifications and, if the procedures l

allow renewals without examination, require evidence of recent full-time l employment and annual refresher training.

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7. Provide a timely response to inquiries, by telephone or letter, from member:: of the public, about an individual's certification status.

III. Requirements for Written Examinations.

All examinations must be:

1. Designed to test an individual's knowledge and understanding of the l topics listed in i 34.43(g) or equivalent Agreement State requirements; l 115 l

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2. Written in a multiple-choice format;

3. Have test iter.es drawn from a question bank containing .

psychometrically valid questions based on the material in 5 34.43(g).

PART 71 - PACKAGING AND TRANSPORTATION OF RADI0 ACTIVE MATERIAL l

4. The authority citation for Part 71 continues to read as follows:

AUTHORITY: Secs. 53, 57, 62, 63, 81, 161, 182, 183, 68 Stat. 930, 932, 933, 935, 948, 953, 954, as amended, secs. 1701, 106 stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2077, 2092, 2093, 2111, 2201, 2232, 2233, 2297f); secs. 201, ,

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

Section 71.97 also issued under sec. 301, Pub. L.96-295, 14 stat. 789-790.

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5. In 5 71.101 a new paragraph (g) is added to read as follows:

5 71.101 Quality assurance requirements.

(g) Radiography containers: A program for transport container inspection and maintenance limited to radiographic exposure devices, source

changers, or packages transporting these devices and meeting the requirements of 5 34.31(b) or equivalent Agreement State requirement, is deemed to satisfy the requirements of 55 71.12(b) and 71.101(b).

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PART 150 - EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN AGREEMENT STATES AND IN OFFSHORE WATERS tlNDER SECTION 274 .

6. The authority citation for Part 150 continues to read as follows:

AUTHORITY: Sec.lbi,.68 Stat.948, as amended, sec. 274.73 Stat. 688 (42 '

U.S.C. 2201, 2021): sec. 201.88 Stat 1242, as amended (42 U.S.C. 5841).

Sections 150.3, 150.15, 150,15a, 150.31, 150.32 also issued under secs.

l 11e(2), 81, 68 Stat.923, 935, as amended, secs. 83, 84, 92 Stat. 3033, 3039 l (42 U.S.C. 201.4(e), 2111, 2113, 2114). Section 150.14 also issued under sec.

53, 68 Stat. 930 as amended (42 U.S.C. 2073). Section 150.15 also issued under secs. 135,141, Pub. L.97-425, 96 Stat. 2232, 2241, (42 U.S.C.10155, 10161,). Section 150.17a also issued under sec.122.66 Stat. 939(42 U.S.C.

2152). Section 150.30 also issued under sec. 234.83 Stat. 444 (42 U.S.C.

2282).

7. In i 150.20, paragraph (b) is revised to read as follows:

(b) Notwithstanding any provision to the contrary in any specific j license issued by an Agreement State to a person engaging in activities in a l

l non-Agreement State or in offshore waters under the general licenses provided l in this section, the general licenses provided in this section are subject to l

the provisions in il 30.7(a) through (f), 30.9,30.10,30.14(d),30.34,30.41, 30.51 to 30.63, inclusive, of 10 CFR Part 30 of this chapter; il 40.7(a) through (f), 40.9, 40.10, 40.41, 40.51, 40.61, 40.63 inclusive, 40.71 and l 40.81 of 10 CFR Part 40 of this chapter; il 70.7(a) through (f), 70.9, 70.10,

! 70.32, 70.42, 70.51 to 70.56, inclusive, 70.60 to 70.62, inclusive, and to the i

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l l provisions of 10 CFR Parts 19, 20 and 71 and Subpart C through H of 10 CFR Part 34, il 39.15 and 39.31 through 39.77, inclusive, any person engaging in .

l activities in non-Agreement States or in offshore waters under the general licenses provided in this section:

l Dated at Rockville, Maryland, this day of 1996.

For the Nuclear Regulatory Comission.

John C. Hoyle, Secretary of the Comission.

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ENCLOSURE 2 1

i j FEDERAL REGISTER NOTICE

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h POL CY STATEMENT: MODIFICATION i

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[7590-01-P]

NUCLEAR REGULATORY COMMISSION Revision of the NRC Enforcement Policy l AGENCY: Nuclear Regulatory Comission.

l ACTION: Policy Statement: Modification.

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SUMMARY

The Nuclear Regulatory Comission (NRC) is publishing a modification to its Enforcement Policy to add examples for categorizing the significance of 1

violations of 10 CFR Part 34, Licenses for Radiography and Radiation Safety Raquirements for Radiographic Operations. By a separate action published l

today in the Federal Register, the Commission has issued a final rule amending 10 CFR Part 34. The modification to the Enforcement Policy reflects thos!

amendments.

DATES: Consistent with the amendments to 10 CFR Part 34, th'is action is l effective in 90 days or on the day the particular provision of 10 CFR Part 34 become effective. Coments submitted within 60 days of publication of this modification will be considered.

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l ADDRESSES: Send written coments to: The Secretary of the Commission, U.S.

Nuclear Regulatory Comission, Washington, DC 20555. ATTN: Docketing and I

, Service Branch. Hand deliver comments to: 11555 Rockville Pike, Rockville, 1

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t 4 Maryland, between 7:45 am and 4:15 pm, Federal workdays. Copies of comments received may be examined at the NRC Public Document Room, 2120 L Street, NW. -

(Lower Level), Washington, DC.

l l FOR FURTHER INFORMATION CONTACT: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555,(301) 415-2741.

l l SUPPLEMENTARY INFORMATION:

l The Commission's Enforcement Policy was first issued on September 4, 1980. Since that time, the Enforcement Policy has been revised on a number of 1

occasions, most recently on June 30, 1995 (60 FR 34381). The Enforcement Policy was also published as NUREG-1600, General Statement of Policy and Procedure for NRC Enforcement Actions. As a result of amendments to 10 CFR Part 34 being published today as a final regulation, revisions are warranted to the Enforcement Policy to provide guidance on categorizing potential violations of the amended requirements. The revisions to the Enforcement Policy are being issued concurrently with the new rule.

The Policy recognizes that violations have differing degrees of safety significance. As reflected in the severity levels, safety significance includes actual safety consequence, potential safety consequence, and regulatory significance. Changes are being made to Supplement VI, Fuel Cycle and Materials Operations, to provide additional or amended examples of violations that are of significant concern and therefore should be categorized at Severity Level III. The changes are:

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1. Example C.4 is being amended to add a reference to uncertified persons. Conduct of licensed activities by an uncertified person is -

significant because the certification demonstrates that the person has received training in accordance with 10 CFR Part 34 or equivalent Agreement State regulation, has satisfactorily completed a minimum period of an on-the-job training, and has received verification by an Agreement State or an NRC licensee that the person has demonstrated the capability of independently working as a radiographer.

2. . Example C.8 is being amended to add a reference to have present emergency notices. A failure, during radiographic operation, to have present emergency notices as required by 10 CFR Part 34 when only one radiographer is present is significant because there needs to be notice to the public if a radiographer is disabled.

3. Example C.12 is being added to address a failure, during radiographic operation, to stop work after a pocket dosimeter is found to be off-scale, or after an electronic dosimeter reads greater than 200 mrem, and before a determination of the individual's actual radiation exposure has been made. This example is significant because of the need to evaluate the potential to exceed regulatory limits and the need to take corrective action.

The existing examples for Severity Level III violations presently address other significant violations of the amendments to 10 CFR Part 34 such as a failure to perform surveys to determine that the sealed source has been returned to its shielded position, to properly monitoring site boundaries for access control, and to utilize qualified RS0s.

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Therefore, the following revision is made to Supplement VI and will be reflected in the next publication of NUREG 1600: -

I SUPPLEMENT VI--FUEL CYCLE AND MATERIALS OPERATIONS C. Severity Level III - Violations involving for example:

4. Conduct of licensed activities by a technically unqualified or uncertified person or;

8. A failure, during radiographic operations, to have present at i

l least two qualified individuals or to use radiographic equipment, radiation survey instruments, and/or personnel monitoring devices as required by 10 CFR Part 34; l

11. A significant failure to meet decommissioning requirements including a failure to notify the NRC as required by regulation or license condition, substantial failure to meet decommissioning standards, failure to conduct and/or complete decommissioning activities in accordance with regulation or license condition, or failure to meet required schedules without i

adequate justification, or I

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12. A failure, during radiographic operations, to stop work after a l pocket dosimeter is found to have gone off-scale, or after an electronic -

dosimeter reads greater than 200 mrem, and before a determination is made of the individual's actual radiation exposure have been made.

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l Dated at Rockville, Maryland, this day of 1996.

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For the Nuclear Regulatory Commission.

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John C. Hoyle, i Secretary of the Commission.

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4 ENCLOSURE 3 4

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! REGULATORY ANALYS S I

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l REGULATORY ANALYSIS OVERALL REVISION OF 10 CFR PART 34 -

1.0 Statement of the Problem The NRC has not initiated an overall revision of 10 CFR Part 34 in many years. During this time, a number of Agreement States have revised and updated their radiography regulations. The decision to develop an overall revision to 10 CFR Part 34 was made with the intent of establishing new safety requirements for radiography licensees and clarifying the regulation so that 1

licensees will have a better understanding of what is expected in radiographic '

operations.

1.1 The Industry The radiography industry, which is the concern of this regulatory l

analysis, consists of approximately 450 firms in the United States that perform radioisotope radiography either at fixed locations or at multiple temporary jobsites. This industry employs about 10,000 full-time radiographers and radiographers' assistants. Approximately 160 of these firms are NRC licensees, employing about 3,200 workers of which about 800 are assumed to be radiographers' assistants (about 5 per licensee) and 2400 are radiographers (about 15 per licensee). The remainder of the firms (290) are l

Agreement States licensees. Roughly 20 percent of NRC licensed firms (30) conduct radiography at a single location, the other 80 percent (130) work at multiple locations generally referred to as temporary jobsites. Approximately 90 percent of the licensees are considered "small entities" under the criterion established in Section 605(b) of the Regulatory Flexibility Act of 1

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1980. Radiography device utilization by the industry is typically 0.4 radiography devices per individual or 2 devices for every 5 radiography -

personnel. The industry is believed to have approximately 4,000 devices in use, of which 1,200 are used by NRC licensees. Typically, radiographic exposure devices employ either cobalt-60 or iridium-192 radioisotope sources.

Most of the radiography licensees are in the business of non-destructive testing, in which radiography represents only part of their total income; however, a few firms work only in radiography. Much of the work in the field (e.g., temporary jobsites) involves the inspection of welds in bridges; oil, gas, and other pipelines; and in the steel framework of commercial buildings under construction.

1.2 Changes The changes to 10 CFR Part 34 are directed at improving industrial radiography safety performance. This revision specifies requirements for mandatory certification of radiographers, a re-definition of a permanent radiographic installation, new requirements for the designation of and the qualifications for a Radiation Safety Officer (RS0), reduced mandatory inspection frequency of radiographers' and radiographers' assistants' performance, additional training for radiographers' assistants, specification of required documents at various radiographic operations sites, additional recordkeeping and labeling requirements, reduced frequency of survey meter calibrations, and a new requirement for leak testing of radiographic exposure l devices. A number of the changes involve a reorganization of the regulations for clarification. The revision includes some new definitions and the redefinition of some terms in the present regulation.

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2.0 Objectives The NRC is revising its regulations governing industrial radiography for -

purposes of improving radiography safety. The revision includes additional I safety requirements that will enhance the level of protection of l l

radiographers, radiographers' assistants, and the public, and clarifies the regulations so that licensees will have a better understanding of what is 1

expected in radiographic operations. There has not been an overall revision  !

of 10 CFR Part 34 in many years while many of the Agreement States have I

updated their radiography regulations. This revision incorporates certain provisions of the updated Agreement State regulations. The format of this revision has been modified to place requirements into categories that describe l the type of requirements that are found in each subpart. I I

3.0 Alternatives The alternatives are to revise 10 CFR Part 34 as planned, adopt the proposed requirements with the exception of the "two-person rule," or to take no action at this time and continue the status quo.

Alternative 1 - Revise 10 CFR Part 34 as Planned Adoption of this alternative would result in a comprehensive revision of I l

10 CFR Part 34. Many of the changes involve rearrangement of sections of the current regulation and rewording to make the regulations more understandable. l l

The revision would also make 10 CFR Part 34 more consistent with Agreement State regulations.

The most significant new requirements are for two-qualified individuals to always be present whenever radiographic operations occur outside of a 3

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permanent installation, mandatory certification of radiographers, and additional requirements for Radiation Safety Officers. Other changes to -

l 10 CFR Part 34 brought about by this rulemaking include: recordkeeping, labeling, additional training for radiographers' assistants, and additional testing of certain radiographic exposure devices. ,

Alternative 2 - Revise 10 CFR Part 34 as Planned, But Do Not Adopt the "Two-person Rule" Adoption of this alternative would include all of the proposed requirements discussed in Alternative 1, except for the provision to require two qualified individuals to always be present whenever radiographic operations are performed outside a permanent installation.

Alternative 3 - No Action Alternative 3 would be to take no action at this time and continue in the status quo. This alternative would leave in place those portions of the current 10 CFR Part 34 that are inconsistent with the regulations of many Agreement States.

4.0 Impacts Alternative 1 - Revise 10 CFR Part 34 as Planned

1. NRC Adopting Alternative 1 should not have a significant impact on NRC resources to review license applications since most of the additional requirements in this overall revision would not require license amendments.

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Little additional time will be needed to inspect implementation of the additional requirements. . Currently, it takes a week to review a license -

application, and three-quarters to one day to inspect a licensee. The additional requirements specified in this alternative should not substantially increase either application review or inspection time, t

2. . Licensees The discussion of the impacts of this rule on NRC licensees is separated l into (a) major impacts that would result from substantive new requirements, and (b) minor impacts that would result from requirements such as additional l recordkeeping and device testing. The impacts for Agreement States were not included in this assessment because several Agreement States already l

incorporate many of the requirements of this revised rule in their regulations. Multiplying the values obtained in this analysis by a factor of l 3 will provide an upper estimate of the total costs for both NRC and Agreement State licensees to implement the rule, and assumes that all Agreement States would need to adopt these requirements.

a. Maior Impacts

i. Two-Person Crews The two-person crew requirement can add to the cost of performing radiography at locations where there is no permanent radiographic installation. Nonetheless, a number of Agreement States have had such a requirement in their regulations for several years, and consider it both necessary and beneficial. In many of these States the requirement is to have a minimum of two fully qualified radiographers at each temporary jobsite. In

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l these States radiographers' assistants or radiographer trainees, although present and working at the jobsite, are not considered to be part of the -

j required two-person crews. The NRC requirement, however, would specify that l

l the two-person crew as a minimum be composed af one qualified radiographer and one individual who meets the qualifications of a radiographer's assistant.

Radiographer's helpers, used by some of the larger radiography licensees to patrol and survey radiation boundaries, and not trained to the level of a radiographer's assistant, would not qualify to be members of the two-person crews.

As stated previously, 80 percent of the industrial isotope radiography occurs at locations other than permanent radiographic installations. It is assumed that approximately one-fourth (800) of the NRC radiography personnel l discussed in Section 1.1 are radiographers' assistants. Also, it is assumed, for the purpose of estimating the cost of the two-person crew amendment, that under the present regulations 70-85 percent of the jobsites require two or more radiographers or radiographers' assistants. NRC regulations have always required licensees to maintain visual surveillance of radiographic operations 4 l

l to protect against unauthorized entry into a high radiation area. In many l

cases, this requires the presence of more than one qualified individual, therefore a large percentage of NRC licensees are already using two or more individuals at temporary job sites. This requirement would affect only those I

situations in which licensees use only one qualified radiographer in the i

performance of radiography.

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l The additional cost of implementing this requirement is estimated to be i

$24,000 per licensee per assistant. This figure was calculated by using the following: a radiographer's assistant is paid $12 per hour (including i ,

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benefits), works 2,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> per year, and thus, earns $24,000 per year. It is estimated that of the 15-30 percent of the field or temporary radiography -

jobs which do not currently require a two-person crew, some 50-75 percent of i licensees already use 2-person crews on a voluntary basis. Therefore, the assumption is made that under the new requirement 30-60 licensees would each need to hire 1-3 radiographers' assistants. At a cost of $24,000 per l assistant this would result in an implementation cost in the range of $24,000-

$72,000 for each of the 30-60 licensees. The estimated implementation cost to )

the NRC regulated radiography industry is in the range of $720,000-

$4.3 million. The projected 10 year operating and maintenance cost would be in the range of $168,480-$505,440 per licensee, based on each of the 30-60 licensees spending between $24,000 and $72,000 per year for 10 years, discounted at a rate of 7 percent. The total cost over 10 years would be in l the range of $5.1-$30.2 million for the 30-60 affected NRC licensees used in the analysi:. The annual non-discounted operating and maintenance costs for the two-person rule is the same as the implementation cost.

ii. Mandatory certification for radiographers The revision to the training requirements in 5 34.43(a) requires mandatory certification for all radiographers. Currently, certification has been optional under 10 CFR Part 34, and to date 644 radiographers have been certified through the voluntary ASNT program.

In developing the voluntary radiographer certification rule (see 56 FR 11504; March 19, 1991), the ASNT estimated that the cost to the industry for certification to be approximately $300 to $400 per radiographer. These estimated costs consist of $95 for examination and certification fees for ASNT 7

members, $140 for non-members. The remainder represents estimates for travel, food, and lodging for persons applying for certification. Travel costs, which-represented a significant fraction of the total cost, could not be estimated 1

with certainty because the number of locations at which the examination would l be-offered was uncertain. ~However, ASNT has indicated that it expects to offer the examination at as many locations as possible. Therefore, most -!

j examinees could travel to and from the testing site by automobile the same day, thus eliminating lodging costs. Under these circumstances, the staff estimates.the cost of travel and food to be about $100. The ASNT certification is valid for 5 years, and those who qualify for re-certification without examination will be charged $55 for members and $100 for non-members. I l

Individuals who fail the examination will be charged $60 to re-take the examination. For the purpose of this analysis, the initial cost is estimated

, to be $240 ($140 ASNT non-member fee and $100 travel costs) per radiographer, l

and $3,600 per NRC licensee, assuming 15 radiographers per NRC licensee. The l cost for re-certification without examination is estimated to be $200 ($100 l

.ASNT non-member fee + $100 travel costs) per radiographer. For those i 1

radiographers who.would require re-testing, the cost would be higher.

Assuming all radiographers are not ASNT members this would result in an initial industry fee of $576,000 for all 160 NRC licensees, and an annual L estimated operating and maintenance cost of $96,000 if one-fifth of the total number of radiographers are re-certified per year (certification remaining valid for 5 years). This translates into an annual cost for each licensee of

$600. -The projected 10 year operating and maintenance cost will be $4,212 for each licensee and $673,920 for all NRC licensees.

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1 iii. Additional Training of Radioaraphers' Assistants I Paragraph 34.43(b)(1) will require that the radiographers' assistants be-given instruction in the following portions of Il 30.7, 30.9, 30.10, and applicable sections of 10 CFR Parts 19 and 20. They must also be given instruction in applicable Department of Transportation (DOT) regulations and  !

in the NRC license (s) under which the radiographer will perform radiography.

This is in addition to the current requirements to provide instruction in the  ;

licensees operating and emergency procedures. It is estimated that this requirement will entail an additional day of training for all radiographers' '

assistants. Making the assumption that each of the 160 NRC licensees currently have 5 radiographers' assistants and some of them (30-60) will hire l 1-3 assistants to meet the two-person rule for a total of 830-980 assistants, and a further assumption that one radiographer's assistant will be replaced i each year per licensee, the costs of the additional training can be determined as follows: if each radiographer's assistant is paid a salary of $12 per hour (including benefits), and each receives 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of instruction, it would result in a cost of $96 per assistant or a cost of $480 to $768 per licensee for all 5 to 8 assistants, plus a cost to the licensee of $240 ($30/hr X 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br />) for salary and benefits of the RSO who will conduct the training; for a total one-time licensee cost of $720 to $1008. This estimate assumed that the RSO would conduct the training of all of the licensee's radiographers' assistants at the same time. The result of these assumptions is an additional one-time impact for all 160 NRC licensees of $115,200 to 161,280. Replacing only one radiographer's assistant each year would result in an annual cost of

$336 per licensee to train a replacement radiographer's assistant. This cost ,

l accounts for the $96 for salary and benefits and the $240 for the RS0 l l

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I iii. Radiation Safety Officer The requirement in 5 34.13(g) to designate a Radiation Safety Officer -

(RS0) is new. Currently, Regulatory Guide 10.6, describes the information l I

applicants must submit in applying for a license. The guide requests the ,

l applicants to submit the name of the individual who would be responsible for the supervision of the radiation safety program. In addition, the guide states that this individual should be a qualified radiographer wi' a minimum of 1 year of actual experience as a radiographer, but the guide de not specifica1.ly list the duties of this individual. The new 5 34.42 lists both l the qualifications and the specific duties of the RSO.

The first item listed under the RS0's qualifications in 5 34.42, namely, the requirement to complete the training and testing requirements for a qualified radiographer, should not have any significant economic impact on i licensees. The second item requires that the RSO have a minimum of 2,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> of hands-on experience in industrial radiographic operations as a qualified radiographer as required by 5 34.43(a) and have 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of training in the establishment and maintenance of a radiation protection program. It is

believed that this additional training could cost each licensee $1,800 ($500 l

l for the training, $500 for the transportation to and from the training, $320 for meals, lodging, and expenses while attending the training, and $480 in salary and benefits ($30/hr X 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br />)). This results in an initial cost of

$288,000 for the estimated 160 NRC licensees. Also, this estimate assumes that currently, there are no RS0s who would meet the requirements of the new rule, which is unlikely.

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! 10-year projected operating and maintenance cost savings of $16,532,100 to all

! NRC licensees, or an average of about $127,170 per licensee. -

2.b. Minor Impacts

i. Testina for Depleted Uranium (DU)

Section 34.27(e) of the final rule requires that licensees leak-test those radiographic exposure devices containing DU shielding in which the l

source is moved from its shielded position in the device to an unshielded  ;

position outside the device by means of a control cable. The purpose of the I

( leak-test is to verify that the "S" tube, through whics the cable moves, has not been degraded to a state where the control cable function could be j

limited. Such leak-tests are to be performed at intervals not to exceed 12 months and may be performed by the licensee using acceptable leak-test t

kits. Alternatively, the licensee may return the device to the manufacturer for performance of the leak-test. If the testing reveals the presence of DU 1

contamination, the exposure device must be removed from use until an evaluation of the wear of the "S" tube has been made. The estimated cost for j such a leak-test is estimated to be $25 if the licensee performs the leak-test l

and $75 if the leak-test is performed by the manufacturer. Using an average  ;

cost of $50, the cost to NRC licensees to perform the leak-test on the approximately 1,200 devices in use is $60,000 annually, or approximately $375 per licensee. Based upon past experience, wear of the "S" tube occurs only after an average of around 6 years of use, indicating that approximately 200 devices per year will indicate the presence of DU contamination and require additional evaluation. Assuming the cost of shipping the device to the manufacturer or other qualified evaluator plus the cost of the evaluation to l 12

l conducting the training. The projected 10 year operating and maintenance cost would be $377,395 for all 160 NRC licensees. .

iv. Ir.spections of Radioaraphers and Radicaraphers' Assistants Durina l

l Actual Operations The frequency of inspections of the job performance of radiographers and I radiographers' assistants would be changed from quarterly to semiannual. This j change would provide some relief to licensees by reducing the costs of l i inspections of on the job performance by 50 percent. Assuming that the 1 l

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licensee's RSO performs the inspections, that each inspection takes 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />, and the RS0's salary and benefits are on the order of $30 per hour, the cost j to each NRC licensee is about $590 per inspection, assuming a cost of $500 for the RS0's travel expenses to temporary jobsites per inspection. Under the l

current regulation, inspections are required every 3 months for each worker.

Assuming that each licensee that performs radiography in a permanent facility l has an average of 10 individuals, the current annual cost to the 30 licensees that perform radiography in a permanent facility is $108,000, using 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> of

the RS0's time per individual. By assuming that each licensee performing ,

l 1 field radiography has an average of 20 individuals (or 15 teams assuming that i

l under the current rule some teams are comprised of 3 individuals and some may l be lone radiographers) the current annual cost to the 130 licensees is l

$4,602,000. Therefore, these inspections currently cost the NRC licensed industry $1,177,500 per quarter or $4,710,000 per year. This rulemaking revises the inspection period from a quarterly basis to a semiannual basis and would result in an operating and maintenance cost savings of $2,355,000 to all NRC licensees or an average of $18,115 per licensee. This results in a 11 l

be $150 per device, the additional cost to these licensees would be $30,000, with a total cost of $90,000 to all licensees or approximately $563 per -

licensee. The projected 10 year operating and maintenance cost, including shipping, will be $631,800 or $3,952 per licensee.

ii. Documents Reauired at Various locations Section 34.89 requires certain documents to be available at field stations and temporary jobsites. A field station is a location where radiography equipment is stored and from which equipment is dispatched to temporary jobsites where radiography is to be conducted. Because most permanent installations are located at a licensee's place of business where all records are normally stored, this requirement will impact only those 130 licensees that operate at temporary jobsites or field stations. The impact on NRC licensees to have these documents available will be a $150 cost per licensee per year with an industry cost of $19,500. This was determined assuming a $10 per hour labor rate for clerical staff (including benefits),

and an estimated 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> to have the documents available. The projected 10-year operating and maintenance cost will be $136,890, iii. Recordkeepina, Notifications and Labelina Other changes that appear in this revision fall into the realm of recordkeeping and include the addition of required signatures, listing of serial numbers of devices in use in the utilization logs, records of depleted uranium leak-tests performed, written notifications whenever a material will be used or stored for more chan 180 days at a location not listed on the license, and at a minimum, a sign to alert the public of the potential hazard

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in the event the radiographer becomes incapacitated. New requirements for recordkeeping, notifications and labeling are expected to cost approximately -

$200 per licensee or a total of $32,000 for all NRC licensees. The projected 10-year operating and maintenance cost will be $224,640.

iv. Radiation Survey Instruments The calibration interval for radiation survey instruments is being extended from 3 months to 6 months since it is believed that more frequent calibration is not needed and that any change in instrument response would be detected during the daily operability check of the meter. These changes will provide some relief to licensees by reducing the costs of radiation survey instrument calibrations by 50 percent. The cost of calibrating a radiation survey instrument is approximately $100 per instrument. Assuming that there is a total of 1,200 radiation survey instruments that must be calibrated every 3 months, the operating and maintenance costs would be $120,000. By requiring the instruments to be calibrated every 6 months the annual savings to all licensees would be $240,000 or $1,500 per licensee. The projected 10-year operating and maintenance cost will be $1,684,800 or $10,530 per licensee.

v. Permanent Radiographic Installations Although the current regulation requires both visible and audible warning signals to be installed at " permanent radiographic installations,"

some licensees have misinterpreted the requirement and have classified what should be permanent installations as temporary jobsites, and have not installed the required warning signals. This rulemaking revises the definition of a permanent radiographic installation. As noted above, 14

annual fee reduction to the radiography industry of $30,200 for new, amended, F

or renewed approvals and an additional reduction of $130,000 in annual fees. -

Alternative 2 - Revise 10 CFR Part 34 as Planned. But Do Not Adopt the "Two-person" Rule

1. NRC l Adopting Alternative 2 should not have a significant impact on NRC resources to review license applications since most of the additional requirements in this overall revision would not require license amendments.

l. Little additional time will be needed to inspect implementation of the-additional requirements. Currently, it takes a week to review a license application, and three-quarters to one day to inspect a licensee. The additional requirements specified in this alternative should not substantially increase either application review or inspection time.

I l 2. Licensees The consequences of this alternative would be the r .ne as Alternative 1, l

except that the provision for the "two-person" rule would not be adopted.

Based on occupational exposure data submitted to the NRC on an annual basis,

the maximum likely benefit from adoption of the two-person provision would be l

to avoid 1-2 overexposures per year (6-100 rem of averted dose). In addition, 2-3 severe extremity or skin overexposures with deterministic effects might be l

avoided over a 10-year period. By assuming that adoption of the mandatory two-person provision would result in elimination of radiography overexposures

, at the level _ experienced in the last 10 years, the $2,000/ person-rem guideline

would indicate that the annual cost would need to be less than $80,000 to

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approximately 20 percent, or 30, of the NRC licensees operate at single locations. This rulemaking will result in an initial cost of $3,000 per -

facility for installation of alarms, and an annual cost of $50 for operating and maintenance per NRC licensee. It is unlikely that all NRC licensees will need to install additional alarms. If an assumption is made that the 30 licensees cited above are the only ones with radiography cells, and that j one-half would need to install additional alarms-to meet the new requirements, there would be an initial industry cost of $45,000 for the 15 licensees l

installing additional alarms with a projected 10-year operating and maintenance cost of $351 per licensee and a total of $5,265 for the 15 licensees used in the analysis, vi. Quality Assurance Currently, radiography licensees that transport radioactive material in i

a Type B container are required by i 71.12(b) to have a Quality Assurance (QA)

Program approved by the Commission in addition to a radioactive material

! license. Since radiography licensees will no longer be required to apply for QA Program approval, they will no longer need to pay the fees associated with -

the approval.

l Cost savings associated with this rule change only apply to those j radiography licensees that are not licenses for permanent installations, or 130 radiography licensees. Fees associated with a QA program approval are as l

follows: initial application - $320; amendment - $240; renewal - $340; annual fee - $1,000. Approximately 40 new programs approvals, 30 amendments, and 30 I renewals are issued each year to radiography licensees. Using the fees and

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actions taken on approvals as specified above, this rulemaking results in a l i

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makes NRC's requirements consistent with the Agreement State regulations, but may result in a final rule that is not cost-effective. The second alternative .

would make NRC's requirements less consistent with the Agreement States' regulations and would not include the "two-person rule," but would result in a j rule with a cost savings.

The first alternative was chosen, even though there may be some cost i associated with its adoption, on the basis that there will be an overall i

enhancement in safety by always requiring a second qualified individual at temporary jobsites. Because industrial radiography involves the use of highly radioactive sources, there is a need to have high assurance that sufficient measures are undertaken to ensure that the source remains in its shielded position when not in use. More overexposures have resulted in the radiography industry than in any other licensed activity, primarily due to inadequate source and equipment handling. By requiring a second qualified individual to be present, there will be greater assurance that the radioactive material will l be properly handled, thus, reducing the potential for additional overexposures.

6.0 Implementation The finai rule will be published in the Federal Register and will include an effective date for implementation of the changes to allow licensees time to make the required changes.

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i l Justify inclusion of the two-person requirement, and the lowest estimated I l 10 year operating cost is $5.lM. Table 2 shows that without this provision, -

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there would be an overall cost savings to all NRC licensees of $21 million, l when a discount rate of 7 percent is applied over a 10-year period. However, l

l it should be pointed out that NRC licensees would still need to use two-person crews when working in certain Agreement States which will result in increased l expense to these licensees. Both Texas and Illinois require both individuals l l \

l to be certified radiographers. l

! Alternative 3 - No Action l The primary consequences of this alternative would be that although NRC l

! licensees would be free to voluntarily implement some or all of the

! recommendations made by the Agreement States, they would not be required to do l

l so under 10 CFR Part 34. This would continue the status quo of having i different standards in the Agreement States, would not have the potential benefit of reducing the frequency of overexposures in radiography, and would not provide any of the regulatory reliefs.

5.0 Decision Rationale The changes presented in the proposed revision were carefully chosen on the basis of recommendations from the radiography industry, including users i and manufacturers of radiography equipment, and the Agreement States. As l

l indicated in the Alternative section above, the decisions available are to revise 10 CFR Part 34 as proposed, revise part 34 as proposed but not adopt the "two-person rule," or to take no action at this time. The first alternative incorporates the recommendations of the Agreement States and thus 17

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, a 7.0 Costs.

A summary of the costs of the above amendments, based on the estimates .

made above are given in Table 1 for Alternative 1 and in Table 2 for Alternative 2.

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t Table 1 Implementation and Annual Operating and Maintenance Costs for Alternative 1 New Requirement implementation Cost Total Present Worth of Operating and Annual Operating Maintenance Cost

• and Maintenance (1995 Dollars) (1995 Dollars) Cost' l (1995 Dollars)  !

Per NRC All NRC I Per NRC. All NRC Per NRC Licensee Licensee Licensees Licensee Licensees Two-person rule

• 24,000 to 72,000 720,000 to 4.3M 168.480 to 505,440 5.1M to 30.2M 24,000 to 72,000  :

Mandatory Certification for 3,600 576,000 4.212 673,920 600  !

Radiographers

[

Radiation Safety Officer 1,800 288,000 0 0 '

0 3 Additional Training for 720 to 1008 115,280 to 2,359 377,395 336 7 Radiographers' Assistants 161,280 f Reduced Field Inspection 0 0 -127,170 -16,532,100 -18.115 t

Costs i i

! Depleted Uranium Tests 375 60,000 3,952 631,800 563 l location of documents and 150 19,500 1,053 136,890 150 records

[

Recordkeeping and 200 32,000 1,404 224,640 -I 200 Labelling i Reduced Rad. Survey Inst. 0 0 -10,530 -1,684,800 -1,500 [

Calibrations f

Pemanent Facility Alarms

• 3,000 4,500 351 5,265 50 i QA* 0 0 -8650 -1,124,604 -1,232 Total 33,845 to 82,133 1.9M to 5.5M 35,461 to 372,421 -16M to +13M 5,052-53,052 Total Cost per NRC Licensee' 69,306 to 454,554 t I

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. *These values were calculated using a 7% discount rate projected over 10 years, i ihese values were not discounted. I

• Cost would apply to the estimated 30-60 licensees who need to hire assistants. )

• An initial cost of $3,000 would apply to the 15 licensees who have to install alarms at their permanent facilities.

• Cost represented were averaged over the 130 licensees that are required to have a QA Program.

'These values represent the O&M cost projected over 10 years at a discount rate of 7% plus the implementation cost. The range represents the projected lowest and highest costs to implement the two-person rule provision. i a

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Table 2 ~

Implementation and Annual Operating and Maintenance Costs for Alternative 2 ummma-New Requirement implementation Cost Total Present Worth of Operating and Annual Operating Maintenance Cost

• and Maintenance (1995 Dollars) (1995 Dollars) Cost *(1995 Dollars)

Per NRC All NRC Per NRC All NRC Per NRC Licensee Licensee Licensees Licensee licensees Mandatory Certification for 3,600 576,000 4,212 673,920 600 Radiographers Radiation Safety Officer 1,800 288,000 0 0 0 Additional Training for 720 115,200 2,359 377,395 336 Radiographers' Assistants Reduced Field Inspection 0 0 -127,170 -16,532,100 Costs

-18.115 Depleted Uranium Tests 375 60,000 3,952 631,800 563 Location of documents and 150 19,500 1,053 136,890 150 records Recordkeeping and 200 32,000 1,404 224,640 200 Labelling Reduced Rad. Survey Inst. 0 0 -10.530 -1,684,800 -1,500 Calibrations Permanent Facility Alarms

• 3,000 45,000 351 5,265 50 QA* 0 0 0 0 0 Total 9,845 1.2M -124,369 -16.1M -17,716 Total Cost per NRC Licensee * ~114,524

• These values were calculated using a 7% discount rate projected over 10 years.

'These values were not discounted.

• An initial cost of $3,000 would apply to the 15 licensees who have to install alarms at their permanent facilities.

• Cost represented were averaged over the 130 licensees that are required to have a QA Program.

• These values represent the O&M cost projected over 10 years at a discount rate of 7% plus the implementation cost.

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. ENCLOSURE 4 4

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1 ENVIRONMENTAL ASSESSMENT

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ENVIRONMENTAL ASSESSMENT AND FINDING OF NO SIGNIFICANT IMPACT REVISION OF 10 CFR PART 34 -

RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RfDIOGRAPHY The Nuclear Regulatory Commission has amended its regulations that apply to industrial radiography to improve radiography safety.

Environmental Assessment l

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Identification of Proposed Action Part 34 of Title 10 of the Code of Federal Regulations specifies the radiation safety requirements for radiographic operations, including performance requirements for industrial radiographic exposure devices, radiation safety requirements for radiographers and precautionary procedures in radiographic operations. This revision imposes the requirements for mandatory certification of radiographers, a requirement for two appropriately trained individuals to be present at all non-permanent radiography sites (5 34.41), additional training for radiographers' assistants (5 34.43), the requirement for a Radiation Safety Officer (5 34.42), and clarifies the requirements for permanent radiographic installations related to installation of alarms and access control devices.

Need for the Proposed Action A number of revisions to the Suggested State Regulations made the NRC regulations different from many of the Agreement States' regulations. There has not been an overall revision of Part 34 in many years while a number of Agreement States have updated their regulations. A decision was made to

a .

develop an overall revision to 10 CFR Part 34 with the intent of clarifying the requirements so that licensees may have a better understanding of what is -

expected during radiographic operations.

5 Environmental Impacts of the Final Actior, The revision of 10 CFR Part 34 should have no significant effect on the human environment. The changes in this revision of 10 CFR Part 34 are directed at improving t'he safety performance of radiographers and assistants in industrial radiography. The revision adds requirements for: mandatory certification of radiographers, two qualified personnel at all non-permanent radiography sites, the duties and qualifications for a Radiation Safety Officer (RS0), maintenance of specific documents at sites where radiographic operations are occurring, additional training for radiographers' assistants, additional recordkeeping and labeling requirements, leak testing of radiographic exposure' devices, and describes when a permanent radiographic installation must be used. A number of the changes involve a reorganization of the regulations for the purpose of clarification, and includes some new definitions, as well as redefinition of some terms in the present regulation.

Normal operations During normal operations, the radiation dose due to external radiation outside of the radiographic exposure device should not be significantly different from the natural background levels present in the area. None of the proposed revisions to 10 CFR Part 34 are intended to increase the radiation dose from normal operations. Although direct radiation is the primary impact from radiography, direct radiation is controlled by the requirements for 2

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design and operation of the radiographic exposure device, surveying and posting requirements to control public access to the area while radiographic -

operations are occurring, and training requirements for personnel handling the sealed sources used in radiography.

Personnel monitoring of the workers handling the radioactive sources confirms that there is minimal risk of public exposure from normal radiographic operations.

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Accidents-The operating history for radiography indicates that the most accidents l involving radiography have only resulted in direct radiation exposure to workers from equipment failures or personnel errors, such as failing to i properly survey the area before handling the equipment. The only cases where members of the public have been exposed to radiation resulted from failure on the part of radiography personnel to properly monitor the restricted area to l

l prevent unauthorized entries by members of the public. The revisions to l

l 10 CFR Part 34 will further reduce the likelihood of this occurrence by upgrading the training of radiographers' assistants, clarifying survey requirements, and by requiring two persons to be present at all non-permanent radiography sites, to prevent unauthorized entry into high radiation areas by

(

l members of the public.

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

was to adopt the revisions as proposed. A second alternative considered was 3

A a to adopt the revisions as proposed, but not adopt the most costly provision

("two-person rule"). The third alternative was to take no action. -

Amendment of the existing regulations, including adopting the provision that requires two individuals to always be present was chosen as the best alternative.

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

Acencies and Persons Consulted -

Consultations on the rule have been held with both Agreement State and industry representatives at workshops held May-1992 in Mobile, Alabama, November 1992 in Dallas, Texas, December 1994 in Houston, Texas, March 1995 in Las Vegas, Nevada, and April 1995 in Rockville, Maryland.

Finding of No Significant Impact l

Accordingly, the Commission nas determined not to prepare an environmental i impact statement for the final rule. Based on the foregoing environmental '

assessment,'we conclude that this amendment will not have a significant effect of the quality of the human environment. i l

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i ENCLOSURE 5 PUBL C ANNOUNCEMENT i

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NRC AMENDS REGULATIONS l GOVERNING SAFETY OF INDUSTRIAL RADIOGRAPHY -

l The Nuclear Regulatory Commission is amending its l

j regulations governing industrial radiography to enhance safety of radiographers and the public and to provide licensees with a better understanding of what is expected in radiography operations.

j Radiography is a process that uses radioactive materials to make X-ray-like pictures of the inside of large objects, such as metal castings or welded pipelines, to see if they contain flaws.

l A person who conducts radiography operations is known as a

" radiographer."

l The NRC has approximately 170 radiography licensees, and the j 29 Agreement States (which are states that have assumed, by agreement, part of the NRC's regulatory authority) have about 330 additional licensees.

l The revised regulations require radiographers to be certified by an independent certifying organization or an Agreement State, in addition to meeting the existing training and

! qualification requirements.

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! The amendments also:

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• Require two qualified persons--a radiographer and a trained assistant--to be present any time radiography occurs at a temporary jobsite.

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o Require licensees to have a Radiation Safety Officer, with responsibility for ensuring compliance with .

} radiation protection rules. The amended regulations

, set out qualifications, duties and training for this position.

• Require additional training for radiographer's assistants.

A proposed rule on this subject was published in the Federal Register .for public comment on February 28, 1994. Changes to the rule were made as a result of comments received, which are discussed in the (date) edition of the Federal Register.

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1 ENCLOSURE 6 1

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i CONGRESSIONAL LETTERS h

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i (s@ hto y 4 UNITED STATES g j 2

NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 2066H001

\*****/ .

The Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510

Dear Mr. Chairman:

l Enclosed for the information of the Subcommittee is a copy of a notice of

! final rule to be published in the Federal Register. The Nuclear Regulatory Commission (NRC) is amending its regulations concerning licenses for industrial radiography for the purposes of updating and improving safety in

radiographic operations. This revision also incorporates certain provisions of regulations that have been adopted by the Agreement States.

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The amended regulations include a requirement for the mandatory certification of radiographers and a requirement for two-person crews at all non-permanent radiographic installations. Both requirements enjoy a large measure of l support from the industry and Agreement States and are meant to improve safety, encourage professionalism, and level the playing field for all '

radiography participants. The anticipated costs to each licensee are expected to be about $34,000 to $82,000 for the first year, depending primarily upon the number of additional personnel required to meet the two-person requirement, and an annual operating cost of about $5,000 to $53,000 in

! subsequent years.

Sincerely, i

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l Dennis K. Rathbun, Director l Office of Congressional Affairs l

Enclosure:

l Federal Register Notice cc: Senator Bob Graham f

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UNITED STATES s* NUCLEAR REGULATORY COMMISSION ,

• WASHINGTON, D.C. 20065 4 001

\*****/

The Honorable Dan Schaefer, Chairman Subcomittee on Energy and Power Committee on Commerce United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the information of the Subcommittee is a copy of a notice of final rule. to be published in the Federal Reaister. The Nuclear Regulatory Commission (NRC) is amending its regulations concerning licenses for industrial radiography for the purposes of updating and improving safety in radiographic operations. This revision also incorporates certain provisions of regulations that have been adopted by the Agreement States.

The amended regulations include a requirement for the mandatory certification of radiographers and a requirement for two-person crews at all non-permanent radiographic installations. Both requirements enjoy a large measure of support from the industry and Agreement States and are meant to improve safety, encourage professionalism, and level the playing field for all radiography participants. The anticipated costs to each licensee are expected to be about $34,000 to $82,000 for the first year, depending primarily upon the number of additional personnel required to meet the two-person requirement, and an annual operating cost of about $5,000 to $53,000 in subsequent years.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Federal Register Notice

! cc: Representative Frank Pallone i

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.I i, ENCLOSURE 7 i

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CONGRESSIONAL REVIEW LETTERS 4

SMALL BUSINESS REGULATORY ENFORCEMENT 4

FAIRNESS ACT OF 1996 i

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l [ 4 UNITED STATES l g j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20656 4001 l

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Mr. Robert P. Murphy l General Counsel '

General Accounting Office i l

441 G. St., NW '

l Washington, DC 20548 i l

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Dear Mr. Murphy:

l Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is l submitting, a final rule revising the regulations concerning licenses for industrial radiography. This revision is for the purposes of updating and improving safety in radiographic operations and incorporates certain j provisions of regulations that have been adopted by the Agreement States.

l The amended regulations include a requirement for the mandatory certification of radiographers and a requirement for two-person crews at all non-permanent radiographic installations. Both requirements enjoy a large measure of support from the industry and Agreement States and are meant to improve safety, encourage professionalism, and level the playing field for all radiography participants. The anticipated costs to each licensee are expected to be about $34,000 to $82,000 for the first year, depending primarily upon i the number of additional personnel required to meet the two-person I requirement, and an annual operating cost of about $5,000 to $53,000 in l subsequent years. We have determined that this rule is not a " major rule" as  !

defined in 5 U.S.C. 804(2). l l Enclosed is a copy of the final rule that is being transmitted to the Office l' l of the Federal Register for publication. The Regulatory Flexibility

! Certification is included in the final rule. This final rule is scheduled to become effective 30 days after publication in the Federal Register.

l l Sincerely, l

Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Final Rule l

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l g&* ~%s y 4 UNITED STATES l g 2

j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 2065M001 t

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\...../ .

The Honorable Al Gore President of the United States Senate Washington, DC 20510

Dear Mr. President:

Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is submitting a final rule revising the regulations concerning licenses for industrial. radiography. This revision is for the purposes of updating and improving safety in radiographic operations and incorporates certain provisions of regulations that have bes? adopted by the Agreement States.

l The amended regulations include a requirement for the mandatory certification of radiographers and a requirement for two-person crews at all non-permanent

radiographic installations. Both requirements enjoy a large measure of support from the industry and Agreement States and are meant to improve safety, encourage professionalism, and level the playing field for all radiography participants. The anticipated costs to each licensee are expected to be about $34,000 to $82,000 for the first year, depending primarily upon the number of additional personnel required to meet the two-person requirement, and an annual operating cost of about $5,000 to $53,000 in subsequent years. We have determined that this rule is not a " major rule" as i

defined in 5 U.S.C. 804(2).

l Enclosed is a copy of the final rule that is being transmitted to the Office of the Federal Register for publication. The Regulatory Flexibil.ty Certification is included in the final rule. This final rule is scheduled to become effective 30 days after publication in the Federal Register.

l l Sincerely, Dennis K. Rathbun, Director l Office of Congressional Affairs

Enclosure:

Final Rule i

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<. k p un q p UNITED STATES g j NUCLEAR REGULATORY COMMISSION o $ WASHINGTON, D.C. 206t50001

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The Honorable Newt Gingrich Speaker of the United States House of Representatives Washington, DC 20515 l

Dear Mr. Speaker:

1 Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness  !

Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is l submitting a final rule revising the regulations concerning licenses for  !

l industrial, radiography. This revision is for the purposes of updating and l l improving safety in radiographic operations and incorporates certain l l provisions of regulations that have been adopted by the Agreement States. l The amended regulations include a requirement for the mandatory certification of radiographers and a requirement for two-person crews at all non-permanent radiographic installations. Both requirements enjoy a large measure of l support from the industry and Agreement States and are meant to improve l safety, encourage professionalism, and level the playing field for all radiography participants. The anticipated costs to each licensee are expected to be about $34,000 to $82,000 for the first year, depending primarily upon the number of additional personnel required to meet the two-person I

requirement, and an annual operating cost of about $5,000 to $53,000 in subsequent years. We have determined that this rule is not a " major rule" as defined in 5 U.S.C. 804(2). I

! Enclosed is a copy of the final rule that is being transmitted to the Office of the Federal Register for publication. The Regulatory Flexibility ,

Certification is included in the final rule. This final rule is scheduled to '

become effective 30 days after publication in the Federal Reaister.

Sincerely, l

Dennis K. Rathbun, Director Office of Congressional Affairs l

Enclosure:

Final Rule l

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