Text

Request for OMB Review & Supporting Statement Re 10CFR30, Rules of General Applicability to Domestic Licensing of Byproduct Matl. Estimated Respondent Burden Is 158,785 H
	ML20210E282
Person / Time
Issue date:	07/22/1999
From:	Shelton B; NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:	;
Shared Package
ML20210E271	List: ML20210E267; ML20210E282;
References
	OMB-3150-0017, NUDOCS 9907280174
	Download: ML20210E282 (25)
	v • d • e

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Please rearl the instructions before completing this form. For additional forms or cssistinc3 in comptting this form, contact your agerc/s P perwork Clear nce Officer. Send two copirs of this form, th3 coll ction instrumsnt to be revizw:d, ths Supporting Statement, and cny addition l documentiti:n to: Offi30 cf inf:rmiti:n cnd R:gul:tiry Aff: Irs, Offica cf 1

Managest..mt and Budget, Docket Library, Room 10102,72517th Street NW, W ::hingt;n, DC 20503 7 [ 7y

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1. Agency /S,sbagency onginating request

2. OMB controlnumber v e jj p f.( d ek

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U.S. Nuclear Regulatory Commission g

a.

3150-0017 b.

3. Type of bbrmebon collection (check one)

4. Type of review requested (check one)

a. New collection g

a Regular

c. Delegated g b. Revision of a currently approved collection

b. Emergency - Approval requested by (date):

c. Extension of a currently approved collection

5. Will this information collection have a a.Yes significant economic impact on a

d. Reinstatement, without change, of a previously approved substantial number of small enttties?

i collection for which approval has expired g

b.No app oEh a ehre

,/

a. Three years from approval date col r h Requested 6

f. Existing collection in use without an OMB control number spirabon date

b. Other (Specify):

7. Title 10 CFR 30, Rules of General Applicability to Domestic Licensing of Hyproduct Material

8. Agency form number (s) (if app / cable)

NA

9. KIywords Byproduct Material, Radiation Protection, Reporting and Recordkeeping Requirements

10. Abstract 10 CFR 30 establishes requirements that are applicable to all persons in the US governing domestic licensing of r:dioactive byproduct material.

11. Affected pubhc (varn onmary atn v and an orners tnat sooty e,rn v)

12. Obligation to tespond i%vn onmary a,tn y ener an ceners ener sooty atn vp

a. Individuals or households

d. Farms a Voluntary T

b. Business or other for-profit T

e. Federal Government

b. Required to obtain or retain benefits T

c. Not-for-profit institutions T

f. State. Local or Tnbal GovemmentT c. Mandatory

13. Annual reporting and recordkeeping hour burden 14 Annual reporting and recordkeeping cost burden en thousands orcroitars)

a. Number of respondents 21.529 a Total annualized capital /startup costs

b. Total annuairesponses 23,337

b. Total annual costs (O&M)

1. Percentage of these responses c Total annualized cost requested collected electronically 0.0

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d current OMB inventory

c. Total annual hours requested 158,785 e oference

d. Current OMB inventory 147,273 f Explanation of difference

o. Difference 11,512 1

gram change f Explanation of difference 285 2 A@stment

1. Program change

2. Adjustment I I *277

15. Purpose of information collection 16 Frequency of record #eeping or reporting (check att that apply)

Strk pomary wirn "P" and all others that apply with "X')

7 a Recordkeeping

b. Third-party disclosure

a. Application for benefits 7

c Reporting

b. Program evaluation e Program planning or management ~)

2. Weekly 3 Monthly

f. Research asion

d. Audit g Regulatory or comphance 7

4 Quarterly 5 Semi-annually

6. Annually

c. General purpose statistics T 7 Biennially

~7 8 Other(describe)1 Tye' ar renewal

17. Statistical methods 18 Agency contact tverson wno can best answer questions regarcing the Dois this information collection employ statistical methods?

Name.

.Iayne McCausiand Q No Yes 301-415-6219

Phone, OMB831 in,s form was oes,9ned wieg inFoes 10/95 9907200174 990722 PDR ORO EUSOPIB PDR

19.C:rtification for P perwork Reducti:n Act Subminisna On behalf of this Federal agency, I certify that the collection ofinformatico encompassed by this request complies with 5 CFR 1320.9.

NOTE: De text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.3 (b)(3h appear at the end of the instructions. The certipcation is to be made with reference to tbase regulatory provisions as setforth in the instructions.

~?4-Re following is a summary of the topics, regarding the proposed collection ofinformation, that the certification covers:

(a) It is necessary for the proper performance of agency functions; (b) It avoids un%cessary duplication; (c) It reduces burden on small entities; (d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; (e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; (f) It indicates the retention periods for recordkeeping requirements; (g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3):

(i)

Why the information is being collected; (ii) Use ofinformation; (iii) Burden estimate; (iv) Nature of response ooluntary, required for a benetit, or mandatory);

(v) Nature of extent of confidentic.lity; and (vi) Need to display currently salid OMB control number; (h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected (see note in item 19 of the instructions);

(i) It uses effective and efficient statistical sursey methodology; and (j) It makes appropriate use ofinformation technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in item 18 of the Supporting Statement.

1 Sgnature of Authorized Agency Official Date S

Sen#or Official or desgnee Date

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Brinda Jo.

C Clearanewn%Gifqof the Chief information Officer 97 OMB 83-1 10/95

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m FINAL SUPPORTING STATEMENT FOR 10 CFR PART 30

" RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL"

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(3150-0017)" '

REVISION TO CLEARANCE EXTENSION k

Description of Information Collection The Nuclear Regulatory Commission's regulations in 10 CFR Part 30 establish rules appMable to all persons in the United States governing domestic licensing of radioactive byproduct j

material. The regulations were issued pursuant to the Atomic Energy Act of 1954, as amended, Title 11 of the Energy Reorganization Act of 1974, as amended, and exemptions from the domestic licensing requirements permitted by Section 81 of the Act. A final rule, Self-Guarantee of Decommissioning Funding by Non-Profit and Non-Bond issuing Licensees,10 CFR Parts 30, 40,50,70, and 72 was codified since the last Part 30 clearance submittal. The additional burden generated by that rule is being incorporated in this package.

A.

Justification 1.

Need for and Practical Utility of the Collection of information Section 30.9(b) requires that an applicant or licensee notify the Commission of information which the applicant or licensee recognizes as having significant implications for public health j

and safety or the common defense and security. This requirement applies only to information which is not already required to be provided to the Commission by other reporting or updating requirements. The information must be provided within 2 working days to the administrator of the appropriate NRC regional office.

This requirement is necessary because there may be some circumstances in which a licensee possesses some information which could be important to the protection of public health and

%/ or the common defense and security, but which is not otherwise required to be reported.

The codification of this full disclosure requirement should not result in significant additional burdens on applicants or licensees. No formal program is required. It is expected that licensees will maintain a professional attitude toward safety and that, if some potential safety information is identified by the licensee, the information will be provided freely and promptly to the NRC so that the agency can evaluate it and act on it, if necessary.

Section 30.11 provides that the Commission may, upon the application of any interested person or on its own initiative, grant exemptions from the requirements of 10 CFR Parts 30-36 and 39 under specified conditions.

The information submitted under this section is examined by the NRC to determine whether the requested exemption is authorized by law, and will not endanger life or property or the common defense and security, and is otherwise in the public interest.

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1 Section 30.15(b) requires that any person who desires to apply byproduct materia: to, or to incorporate it into, the products exempted in Section 30.15(a), or who desires to initially transfer for sale or distribution such products containing byproduct material, apply for a specific license pursuant to Section 32.14. Such a license indicates that the product may be distributed by the licensee to persons exempt from the regulations (hereinafter " exempt persons").

The information on the application is necessary to permit the NRC to determine whether the proposed use of byproduct material provides adequate protection of public health and safety.

The NRC review of the information and the findings therefrom form the basis for NRC licensing decisions. NRC Form 313, " Application for Material License,"is used to collect this information and has previously been cleared under OMB Clearance No. 3150-0120, which should be referred to for additional supporting information, burden, and cost data.

Section 30.18(d) indicates that no person may, for purposes of commercial distribution, transfer byproduct material in the quantities set forth in Section 30.71, Schedule B, to exempt persons, except in accordance with a license issued under Section 32.18.

The information on the application is necessary to permit the NRC to determine whether the proposed use of byproduct material provides adequate protection of public health and safety.

The NRC review and the findings therefrom form the basis for NRC licensing decisions. NRC Form 313, which is used to collect this information, has previously been cleared under OMB Clearance No. 3150-0120, which should be referred to for additional supporting information, burden, and cost data.

Section 30.19(b) requires that any person who desires to manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, or to transfer such products to exempt persons for use, apply for a license pursuant to Section 32.22, with a license provision that the product may be transferred to exempt persons.

The information on the application is necessary to permit the NRC to determine whether the proposed use of byproduct material provides adequate protection of public health and safety.

The NRC review and the findings therefrom form the basis for NRC licensing decisions. NRC l

Form 313, which is used to collect this information, has previously been cleared under OMB Clearance No. 3150-0120, which should be referred to for additional supporting information, burden, and cost data.

Section 30.20(b) requires that any person who desires to manufacture, process, or produce gas and aerosol detectors containing byproduct material, or to initially transfer such products to l

exempt persons for use, apply for a license pursuant to Section 32.26, with a license provision that the product may be initially transferred to exempt persons.

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p The information on the application is necessary to permit the NRC to determine whether the proposed use of byproduct material provides adequate protection of public health and safety.

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' The NRC review and the findings therefrom form the basis for NRC licensing decisions. NRC Form 313, which is used to collect this information, has previously been cleared under OMB 4

Clearance No. 3150-0120, which should be referred to for additional supporting information, burden, and cost data.

Section 30.32(a) requires that applications for specific licenses for byproduct material be submitted on NRC Form 313, " Application for Material License." The NRC reviews the information submitted on the NRC Form 313 to determine whether an applicant for a license has training, experience, equipment, facilities, and procedures for the use of byproduct material that are adequate to protect the public health and safety.

NRC Form 313 has previously been cleared under OMB Clearance No. 3150-0120, which should be referred to for additional supporting information, burden, and cost data.

Section 30.32(b) provides that NRC may require further statements after the filing of the application, and before the expiration of the license, to enable NRC to determine whether the application should be granted or denied or whether a license should be modified or revoked.

Such additional information is sometimes needed to clarify information submitted in the application, or to rectify deficiencies in proposed or existing programs for protection of the public health and safety, the common defense and security, or the onvironment.

The additional information is reviewed by various NRC organizational units to assess the adequacy of the applicant's physical plant, procedures, and plans for protection of the public health and safety, common defense and security, and the environment. The NRC review and the findings therefrom form the basis for NRC decisions concerning the issuance, modification, or revocation of licenses for byproduct material.

The burden and cost associated with further statements is included in the burden and cost data for submittal of applications on NRC Form 313, which has previously been cleared under OMB Clearance No. 3150-0120.

Section 30.32(f) requires that an application for a license to receive and possess byproduct material for the conduct of any activity which the Commission determines will significantly affect the quality of the environment must be filed at least 9 months prior to commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by an environmental report required pursuant to 10 CFR Part 51, Subpart A.

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l Facilities for commercial waste disposal, or other activities covered by this section, are generally j

large and complex and have the potential to significantly affect the quality of the human envitaament. NRC's consideration of environmental effects and balancing of alternatives for the project, as mandated by the " National Environmental Policy Act of 1969," requires the applicant to submit a comprehensive and detailed environmental report. The NRC licensing staff reviews

. the environmental report to assure that it is complete and that it considers and balances attematives for the project in order to best protect the environment.

This section refers to and requires the submission of information pursuant to 10 CFR Part 51.

The collection of information, the burden imposed on respondents, and the cost to the Government are contained in the supporting statement for 10 CFR Part 51, which was previously cleared under OMB Clearance No. 3150-0021.

Section 30.32(a) requires that an application for a specific license to use byproduct material in the form of a sealed source or in a device that contains a sealed source must either identify the source or device by manufacturer and model numbei, as registered with the NRC under Section 32.210 or with an Agreement State, or contain the radiation safety related information that is identified in Section 32.210(c). This information is needed by the NRC to determine the adequacy of the radiation safety properties of the source and device under the conditions of proposed use. This determination is used to establish that the applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property.

The burden and cost data associated with these registrations are included in the supporting statement for 10 CFR Part 32, which was previously cleared under OMB Clearance No. 3150-0001.

Section 30.34(e)(4) permits the Commission to incorporate in any license issued pursuant to the regulations in 10 CFR Parts 30-36 and 39 additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of byproduct material, in addition, reports and the keeping of records may be required, as nece.ssary, to fulfill the purposes of the Atomic

, Energy Act and regulations of the Commission.

Although this regulation imposes no paperwork burden itself, it is cited as the authority, when necessary, for the issuance of orders for the modification of licenses. When the issuance of such orders involves the imposition of reporting or recordkeeping requirements, requests for l

OMB clearance of the specific information collection requirements are submitted, as necessary.

i The information is used by the NRC staff to verify that the licensee has performed required actions in a complete and timely manner.

Section 30.34(a) requires each licensee preparing technetium-99m radiopharmaceuticals from

. molybdenum-99/ technetium-99m generators to test the generator eluates for molybdenum-99 breakthrough in accordance with Section 35.204. The licensee is required to record the results of each test and maintain records of the test results for 3 years.

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The requirement to maintain the records of test results is necessary to permit the NRC inspection staff to determine that nuclear pharmacy licensees and broad medical licensees have l

conducted the tests to determine the amount of molybdenum-99 in technetium-99 radioactive drugs before administration to patients. If excessive molybdenum-99 is present, it would result

. in unnecessary radiation doses to patients.

S.getion 30.34(h) requires that a licensee immediately notify the appropriate NRC regional administrator, in writing, following the filing of a bankruptcy petition by or against the licensee or a controlling or affiliate entity. No action is required of a licensee unless and until a petition for bankruptcy is filed.

This information is needed because a licensee who is experiencing severe economic hardship may not be capable of carrying out licensed activities in a manner that protects public health and safety. In particular, a licensee involved in bankruptcy proceedings can have problems affecting payment for proper handling of licensed radioactive material and for decontamination and decommissioning of the licensed facility in a safe manner. Improper materials handling or decontamination activities can lead to spread of contamination throughout a licensee's facility and the potential for dispersion of contaminated material offsite. Financial difficulties can also result in problems affecting the licensee's waste disposal activities.

l The information provided by the notification is used by the NRC regional inspection and licensing staff, in consultation with headquarters legal and program staff, to determine the need for prompt NRC response or regulatory action in the event of a potential hazard to public health and safety posed by a licensee that does not have the resources to properly secure the licensed material or clean up possible contamination. In addition, prompt notification would allow the Commission to take timely and appropriate action in a bankruptcy proceeding to seek to have available assets of the licensee applied to cover costs of cleanup before funds are disbursed and become unavailable for cleanup.

Section 30.35 sets forth the requirements for financial assurance and recordkeeping for decommissioning. Sections 30.35(a) and (b) specify which licensees are required to submit a decommissioning funding plan or a certification that financial assurance for decommissioning has been provided. Sections 30.35(c) and (d) specify the criteria for and required amounts of financial assurance for decommissioning. Section 30.35(e) specifies the content of the decommissioning funding plan. Section 30.35(f) specifies acceptable methods for providing for financial assurance for decommissioning: either through prepayment; a surety method, insurance or other guarantee method; or, in the case of Government licensees, a statement of intent containing a cost estimate for decommissioning.

Section 30.35(g) requires that each person licensed under 10 CFR Parts 30 and 32-35 keep records of information important to the safe and effective decommissioning of the facility until the license is terminated by the Commission. Licensees are required to list in a single document (to be held by the licensee and updated once every 2 years) identification of all restricted areas where licensed materials were used or stored, all areas outside of restricted areas where documentation is required for unusual occurrences or spills, and all areas outside of restricted f

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m areas where waste has been buried or which contain material such that, if the license expired, the licensee would be required to either decontaminate the area or seek special approval for disposal. This information is needed by the NRC to ensure that no future users of the site will be i

inadvertently exposed to radiation.

The records and reports required by Section 30.35 are necessary for the Commission to determine whether an applicant will be able to carry out the requirements of Section 30.36 which specify that licensed premises must be decontaminated to a level " suitable for release for unrestricted use" before the license may be terminated. NRC will review the information to ensure that adequate funds will be available to ensure that the applicant will conduct decon-tamination efforts in a timely manner and minimize exposure of workers to radioactive materials.

The information will also be used to ensure that the decontamination efforts will reduce the residual radioactive contamination sufficiently to protect the public health and safety after the site is released for unrestricted use.

Section 30.36 specifies procedures for terminating licensee responsibility for nuclear materials and clarifies that a license will continue in effect, with respect to possession of byproduct material, until the Commission notifies the licensee in writing that the license is terminated.

Section 30.36(b)(2)(ii) allows licensees that have an approved decommissioning funding plan to semiannually request a reduction in the amount of their required financial assurance as decommissioning proceeds and radiological contamination is reduced at the site. Section 30.36(d) requires each licensee to notify the Commission in writing of its decision not to renew its license and to either begin decommissioning its site or submit within 12 months of notification a decommissioning plan. Section 30.36(e) requices that coincident with the notification required by Section 30.36(d), licensees maintain all decommissioning financial assurances established by the licensee pursuant to Section 30.35. Section 30.36(g) requires that a decommissioning plan be submitted, if required by license condition or if the proposed procedures and activities necessary to carry out the decommissioning have not been previously approved by the Commission, and these procedures could increase potential health and safety impacts to workers or to the public.

All of the above information required by Section 30.36 is reviewed by the NRC to determine that there is no significant risk to public health and safety before a licensee's responsibility for nuclear materials is terminated and a facility is released for unrestricted use.

Section 30.36(i) requires, as a final step in decommissioning, that a licensee certify the disposition of all licensed material, including accumulated wastes, by submitting a completed NRC Form 314, " Certificate of Disposition of Materials."In addition, this section requires that the licensee conduct a radiation survey of the site where the licensed activities were carried out and 6

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note on NRC Form 314 whether or not the survey was conducted and, if so, attach the results, if l

' not separately forwarded to NRC. The radiation survey, similar to those generated during

~ operations, is required to confirm the absence of radioactive materials or to establish the level of l

residual radioactive contamination. The information on disposal of nuclear materials and the survey are considered the minimum information necessary to establish a record to support a finding that a license can be safely terminated. NRC Form 314 has been previously cleared under OMB Clearance No. 3150-0028, which should be referred to for additional supporting information, burden and cost data.

' Section 30.37(a) requires that an application for renewal of a specific license be filed in accordance with Section 30.32. The NRC reviews the information submitted to determine -

whether an applicant for a license renewal has training, experience, equipment, facilities, and procedures for the use of byproduct material that are adequate to protect the public health and safety.

The burden and cost data for these applications for renewal of specific licenses have been included in the supporting statement for NRC Form 313, which has previously been cleared under OMB Clearance No. 3150-0120.

Section 30.38 requires that an application for amen Jment of a license be filed in accordance with Section 30.32. The NRC reviews the information submitted to determine whether the licensee has training, experience, equipment, facilities, and procedures for the use of byproduct material that are adequate to protect the public he alth and safety.

The burden and cost data for these applicad,ns fo'licem amendments have been included in the supporting statement for NRC Form 313, which has previously been cleared under OMB Clearance No. 3150-0120.

Sections 30.41(c) and (d). Section 30.41(c) requires that, before transferring byproduct material to a specific licensee or a general licensee who is required to register prior to receipt of byproduct material, the transferor must verify that the transferee's license authorizes receipt of the type, form, and quantity of byproduct material to be transferred. Section 30.41(d) specifies methods acceptable to the Commission for accomplishing the required verification, including:

(1)'

The transferor may have in his possession, and read, a copy of the transferee's specific license or registration certificate.

(2)

The transferor may have a written certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of byproduct material to be transferred, specifying the license

- or registration number, issuing agency, and expiration date.

(3)-

For emergency shipments, the transferor may accept oral certification from the transferee, provided it is confirmed in writing within.10 days.

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(4)

The transferor may obtain other sources of information compiled by a reporting service from official records of the Commission or Agreement State licensing agency.

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(5)

When the above methods of verification are not available, the transferor may obtain and record confirmation from the Commission or Agreement State licensing agency.

The information required by Sections 30.41(c) and (d) is used by transferring licensees to provide assurance that the licensed byproduct material is being transferred to a person who is authorized to receive it. This verification serves as an additional check to prevent transfer of byproduct material to persons who may not have the facilities, training, experience, equipment, or procedures necessary for the safe handling of the material. Records of these certifications will be reviewed by NRC inspectors during periodic inspections to ensure that licensees have been complying with verification requirements.

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Section 30.50 requires licensees to notify NRC of events or conditions that threaten the health and safety of individuals either using or potentially exposed to licensed material. Section 30.50(a) requires licensees to notify the NRC as soon as possible, but no later than 4 hours4.62963e-5 days 0.00111 hours 6.613757e-6 weeks 1.522e-6 months , of events that prevent immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed the regulatory limits. Section 30.50(b) requires licensees to notify the NRC within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after the discovery of any of the following events involving licensed material.

Licensees must report unplanned contamination events, such as those in which access to an area must be restricted for more than 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months by imposing additional radiological controls or by prohibiting entry into the area. It is important that the NRC be notified in such cases because accidental contamination events increase radiation exposure and the risk of ingesting radioactive material.

Licensees are required to report events in which equipment necessary to prevent uncontrolled releases of radioactive material, to prevent overexposure to radiation, or to mitigate the consequences of an accident is disabled or fails to function as designed. This includes l

procedural errors, equipment failure, equipment damage, etc. This notification is necessary in l

situations in which there are no backup systems available to perform the required safety I

function. Notification is not required for an individual component failure if redundant systems are operable and available to automatically perform the required function. Licensees are required to report events that require medical treatment of a radioactively contaminated individual at a medical facility. Such events are significant because they may: (1) indicate safety problems in a licensed operation, (2) risk internal contamination through open wounds, and (3) expose medical personnel to radiation and contamination. Prompt notification is necessary so that NRC i

can ensure that an evaluation is performed and that measures are taken to prevent recurrence.

Licensees are also required to report all fires and explosions damaging any licensed material or any device, container, or equipment containing licenced material, so that such events may be promptly evaluated and measures taken to minimize any spread of contamination and determine i

the performance of features designed to controllicensed material.

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l Licensees are required to make the reports required by Sections 30.50(a) and (b) by telephone to the NRC Operations Center, in addition to the telephone report, licensees must submit a written follow-up report within 30 days which includes, in addition to descriptive information, an j

evaluation of the probable cause, a description of corrective actions taken or planned, and the results of any evaluations or assessments.

Section 30.51 establishes overall record retention requirements applicable to byproduct material licensees for cases in which retention periods are not otherwise specified in the regulations.

Section 30.51(a) requires that each licensee who receives byproduct material must keep records showing the receipt, transfer, and disposal of the byproduct material. It provides for retention of records of receipt of byproduct material as long as the material is possessed and for 3 years following transfer or disposal of the material, provides a 3 year retention period for records of transfer of byproduct material, and provides that records of disposal of licensed material must be maintained until the Commission terminates the license that authorizes the disposal.

Section 30.51(b) requires that records which are required by the regulations in 10 CFR Parts 30-36 and 3g or by license conditions must be maintained for the period specified by the i

appropriate regulation or license condition, in any case in which a retention period is not specified, the records must be maintained until the Commission terminates the license that authorizes the subject activity.

Records are necessary as a primary source for determination that licensees have confined their I

possession and use of byproduct material to the locations and purposes authorized in the licenses and have not violated or failed to observe any of the terms and provisions of the Atomic Energy Act or any regulation or order of the Commission. Records of receipt can demonstrate that the licensee has received byproduct material of the element and mass number and in the chemical and/or physical form specified in the license. Records of transfer can demonstrate that the licensee has transferred byproduct material of the type, form, and quantity that transferees are authorized to receive. Records of disposal can demonstrate that the licensee has obtained

approval of disposal procedures and/or has disposed of byproduct material in accordance with NRC regulations. Records of receipt, transfer, and disposal, taken together, can demonstrate that the licensee has possessed at any one time no more than the maximum quantity of byproduct material authorized in the license. The retention periods provide reasonable assurance that records will be available for Commission inspection after the recorded event.

Section 30.55(c) requires that each person who is authorized to possess tritium shall report promptly to the appropriate NRC regional office any incident in which any attempt has been made or is believed to have been made to commit a theft or unlawful diversion of more than 10 curies of such material at any one time or 100 curies of such material in any one calendar year.

The initial report shall be followed within 15 days by a written report which contains the details of the incident, its consequences, and any substantive additional information.

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The information submitted by licensees under this requirement is used by the regional offico to determine whether there has been a diversion or other loss of material and to initiate prompt action in the event of such diversion or loss. The written reports submitted to NRC regional offices are duplicate copies of reports filed with the Federal Bureau of Investigation on the theft or unlawful diversion of tritium.

Accendix A establishes criteria for parent companies to pass the financial test and to obtain a parent company financial guarantee. It specifies various financial ratios, including net worth and asset / liability ratios, and bond ratings. It requires that the licensee notify the NRC within 90 days of any matters coming to the attention of the independent auditor which cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test. If the parent company no longer meets the financial test requirements, the licensee must send notice to NRC of intent to establish alternate financial assurance as specified in the Commission's regulations. The notice must be sent withi190 days after the end.

of the fiscal year for which year-end financial data show that the company no longer meets the financial test requirements. The notice is necessary to permit NRC to take action to ensure that alternative means of financial assurance are available for decommissioning the licensee's site.

Accendix C establishes criteria for companies to pass the financial test and to obtain a self guarantee for financial assurance. It specifies various financial ratios, including net worth ratios, and bond ratings. It requires that the licensee notify the NRC within 90 days of any matters coming to the attention of the independent auditor which cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test. If the company no longer meets the financial test requirements, the licensee must send immediate notice to NRC of intent to establish alternate financial assurance as specified in the Commission's regulations within 120 days. The notice is necessary to permit NRC to take action to ensure that alternative means of financial assurance are available for decommissioning the licensee's site.

Accendix D establishes criteria for applicants or licensees to provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial test of Section 11 of this appendix. The terms of the self-guarantee are in Section Ill.

This appendix establishes criteria for passing the financial test for the self-guarantee and establishes the terms for a self-guarantee. The licensee must inform the NRC within 90 days of any matters that may cause an adjustment in the data specified in the financial test: and/.or if the licensee no longer meets requirements, a notice must be sent to the NRC within 90 days.

Also, alternative financial assurance must be provided within 120 days after the end of such fiscal year.

Aooendix E establishes criteria for nonprofit colleges, universities, and hospitals to provide reasonable assurance of the availability of funds for decommissioning based on furnishing first own guarantee that funds will be available for decommissioning costs and on a demonstration that the applicant or licensee passes the financial test of Section ll of this appendix. This appendix establishes criteria for passing the financial test for the self-guarantee and establishes 10

i the terms for a self-guarantee. The licensee must inform the NRC within 90 days of any matters l

that may cause an adjustment in the data specified in the financial test and/or if the licensee no longer meets requirements, a notice must be sent to the NRC within 90 days. Also, alternative financial assurance must be provided within 120 days after the end of such fiscal year. If the licensee' most recent bond issuance ceases to be rated as "A" or above by Standard cad Poors or Moodys, the licensee shall provide written notice to NRC within 20 days after p6lication of the change by the rating agency.

2.

Aaency Use of the Informatior)

The records that 10 CFR Part 30 requires the licensees to maintain are reviewed during inspections, license renewals, and license amendment reviews to evaluate compliance with NRC radiation safety requirements for possession and use of byproduct material.

The records of receipt, transfer, and disposal of byproduct material are reviewed by the NRC Intpectors to determine that licensees have confined their possession and use of byproduct material to the locations, parposes, receipt, and quantities authorized in their licenses.

Reports of significant safety events and theft of radioactive material are used by the agency in evaluating the protective actions required to avoid exposures to radiation or releases of radioactive materials that could exceed regulatory limits and, therefore, impact public health and safety, the common defense and security, and the environment.

Bankruptcy reports, decommissioning plans, decommissioning funding plans, and certifications of financial assurance for decommidning are reviewed by the NRC to ensure tnat a licensee has adequate procedures and fwds for any necessary clean-up efforts before a licensee's responsibility for byproduct m aterials is terminated and the site is released for unrestricted use.

3.

Reduction of Burden throuoh Information Technoloav There are no legal obstacles to reducing the burden associated with this information collection.

The NRC encourages applicants and licensees to use new automated information technology when it would be beneficial to them. However, the applications and reports do not lend themselves readily to the use of automated information technology for submission because of the varied types of information and the infrequency of submission. Consequently, the current percentage of electronic submissions is zero.

l 4.

Effort to identify Duolication and Use Pimilar Information i

The Information Requirements Control Automated System (IRCAS) was searcned to determine q

duplication. None was found. In general, information required by NRC in applications, reports, j

or records concerning the transfer, receipt, possession, or use of byproduct material does not iuplicate other Federalinformation collection requirements and is not available from any source 1

other than arplicants or licensees. The col!ection of this information by use of specified forms and other required reports and records is the most ef'ective and least burdensome means of l

11

)

r obtaining the information.

There is no similar information available to the NRC that can be used to evaluate compliance with NRC requirements governing the domestic licensing of byproduct material; to ensure public hearth and safety from NRC-licensed activities; and to identify trends and events that must be corrected to ensure continued safe practices.

5.

Effort to Reduce Sm_plqusiness Burden The majority of licensees who use byproduct material are small businesses. Since the health and safety consequences of improper handling or use of radioactive byproduct material are the same for large and small entities, it is not possib's to reduce the burden on small businesses by less frequent or less complete reporting, recordkeeping, or accounting and control procedures.

6.

Conseauences to Fed.eral Proaram or Policy Activities if the Collection is Not Conducted or is Conducted Less Freauentiv If the information is not collected, NRC will have no way to assess whether this category of licensee is operating within the radiation safety requirements applicable to the possession, use, or transfer of byproduct material.

The required reports are collected and evaluated on a continuing basis as events occur.

Applications for new licenses and amendments are submitted only once. Applications for renewal of licenses are submitted every 5 years. Information submitted in previous applications may be referenced without being resubmitted. The schedule for collecting the information is the minimum frequency necessary to assure that licensees will continue to conduct programs in a manner that will assure adequata protection of public health and safety.

7.

Circumstances Which Justifv Variation from OMB Guidelines Contrary to the Office of Management and Budget Guidelines (OMB) in 5 CFR 1320.6(b),

Section 30.9(b) requires that licensees submit a notification to NRC in less than 30 days from the date of it%ntifying information having significant implications for the public health and safety or the common defense and security and which is not coured by other reporting requirements.

The requirement to provide notification within 2 working days following the identification of the information is necessary to ensure that NRC is made aware of the significant safety information so e 'a taka prompt action to protect the public health and safety.

Contrary to the OMB Guidelines in 5 CFR 1320.6(b), Section 30.34(h) requires that licensees submit a notification to NRC in less than 30 days from the date of filing af a petition for bankruptcy. The requirement to provide notification promptly following the filing of the petition u.

necessary to ensure that NRC is made aware of the bankruptcy so as to take effective action to protect the public health and safety. Allowing a period of 30 or more days to elapse might preclude NRC from becoming aware of the licensee's distressed financial circumstances in time to prevent the development or aggravation of a potential hazard to the public. Moreover, the 12

E' v

- United States Code contains requirements regarding notification of creditors in bankruptcy.

Section 30.34(h) would require one additional notification. Notifying NRC promptly after the filing of the petition would in fact be less of a burden on the bankrupt than a separate notification

- later in the proceedings.

Contrary to the OMB Guidelines in 5 CFR 1320.6(f), Section 30.35(g) requires that licensees keep records important to the safe and effective decommissioning of the facility until the license is terminated by the Commission. It is necessary that the secords be retained longer than 3 years so that the Commission may determine whether an applicant will be able to carry out the requirements of Section 30.36 which specify that licensed premises must be decontaminated to a level" suitable for release for unrestricted use" before the license may be terminated. NRC reviews the information to ensure that adequate funds will be available to ensure that the applicant will conduct decontan.ination efforts in a timely manner and minimize exposure of workers to radioactive materials. The information is also used to ensure that the decontamination efforts will reduce the residual radioactive contamination sufficienth to protect the public health and safety after the site is released for unrestricted use.

Contrary to the OMB Guidelines in 5 CFR 1320.6(b), Section 30.36 requires each licensee who does not apply for license renewal to notify the Commission immediately in writing of its decision not to renew its license and to request termination of the 9 cense. This notification in less than 30 days is necessary to permit the NRC staff to determine whether any prompt measures may be needed to ensure that radioactive material is safely transferred or disposed of, and thet there is no significant risk to public health and safety before a licensee's responsibility for nuclear materials is terminated and a facility is released for unrestricted use.

Contrary to the OMB Guidelines in 5 CFR 1320.6(b), Section 30.50 requires licensees to notify NRC immediately (i.e., within 4 hours4.62963e-5 days 0.00111 hours 6.613757e-6 weeks 1.522e-6 months ) by telephone of events or conditions that threaten the health and safety of individuals using licensed material or that prevent the performance of surveys or other safety-related duties necessary to maintain control over licensed material. It is important that the NRC be notified in such cases because accidental contamination events increase radiation exposure and the risk of ingesting radioactive material. Immediate notification is needed so that such events may be promptly evaluated and measures taken to minimize any spread of contamination and determine the performano of features designed to controllicensed material.

Contrary to the OMB Guidelines in 5 CFR 1320.6(f), Section 30.51(a) requires retention of records of receipt of byproduct material as long as the materialis possessed and for 3 years following transfer or disposal, provides a 3 year retention period for records of transfer of byproduct material, and provides that records of disposal of licensed material must be maintained until the Commission terminates the license. Section 30.51(b) requires that reccrds which are required by the regulations in 10 CFR Parts 30-36 and 39, or by license conditions, must be maintained for the period specified by the appropriate regulation or license condition. In any case in which a retention period is not specified, the records must be maintained until the Commission authorizes their disposition.

13

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These records are necessary as a primary source for determination that licensees have confined their possession and use of byproduct material to the locations and purposes authorized in the licenses and have not violated or failed to observe any of the terms and provisions of the Atomic Energy Act or any regulation or order of the Commission Records of receipt can demonstrate that the licensee has received byproduct material of the element and mass number and in the chemical and/or physical form specified in the license. Records of transfer can demonstrate that the licensee has transferred byproduct material of the type, form, and quantity that transferees are authorized to receive. Records of disposal can demonstrate that the licensee has obtained approval of disposal procedures and/or has disposed of byproduct materialin accordance with NRC regulations. Records of receipt, transfer, and disposal, taken together, can demonstrate that the licensee has possessed at any one time, no more than the maximum quantity of byproduct material authorized in the license. Retention for longer than 3 years, where required, is necessary to provide reasonable assurance that records will be available for Commission inspection after the recorded event.

Contrary to the OMB Guidelines in 5 CFR 1320.6(b), Section 30.55(c) requires that each person who is authorized to possess tritium shall report promptly to the appropriate NRC regional office, by telephone and telegraph, mailgram, or facsimile, any incident in which any attempt has been made or is believed to have been made to commit a theft or unlawful diversion of more than 10 curies of such material at any one time or 100 curies of such material in any one calendar year.

The initial report must be followed within 15 days by a wr tten report setting forth the details of the incident and its consequences. Receipt of these reports in less than 30 days is necessary to permit the regional office to determine whether there has been a diversion or other loss of material and to initiate prompt action in the event of such diversion or loss. The written reports submitted to NRC regional offices which set forth the details of the incident, its consequences, and any substantive additionalinformation are duplicate copies of reports filed with the Federal Bureau of Investigation on the theft or unlawful diversion of tritium.

Contrary to the OMB Guidelines in 5 CFR 1320.6(b), Appendix C requires licensees to notify NRC immediately, (i.e., within 4 hours4.62963e-5 days 0.00111 hours 6.613757e-6 weeks 1.522e-6 months ) if the company no longer meets the financial test requirements, of its intent to establish alternate financial assurance as specified in the Commission's regulations within 120 days. It is important that the NRC be notified immediately in such cases to permit NRC to take action to ensure that alternative means of firiancial assurance are available for decommissioning the licensee's site so that the decommissioning will be carried out in a manner which protects public health and safety.

8.

Consultations Outside the NRC An opportunity to comment on the information collection requirements in 10 CFR Part 30 was provided in a Federal Register notice published or, March 31,1999 (64 FR 15381). No comments were received.

9.

Payment or Gift to Resoondents Not applicable.

14

10.

Confidentiality of the information Reports submitted are generally subject to public disclosure in accordance with 10 CFR 2.790 and 10 CFR Part 9. Section 2.790 allows the NRC to withhold certain proprietary information (information of commercial value or " trade secrets") if, at the time of submittal of the report, the requirements for withholding the information are met (refer to 10 CFR 2.790(b)). Also, there are provisions in 10 CFR Part 9 for the NRC to withhold some documents, such as reports of radiation exposure to individuals and other personal records, from public disclosure.

11.

Justification for Sensitive Questions This information collection does not involve sensitive questions.

12.

Estimated Burden and Burden Hour Cost The estimates are based on submittals to NRC in past years. The cost to licensees and applicants is calculated at a rate of $140 per hour for professional staff for the technical reports and records prepared in response to the 10 CFR Part 30 information collection requirements.

This rate is based on NRC's fully recoverable fee rate. The recordkeeping requirements in Sections 30.41(c) and (d), and 30.51 are calculated at a rate of $63 per hour, because these requirements can be fulfilled using automated equipment, computer-generated reports and administrative / clerical staff. These figures include both salaries and overhead.

NRC Licensees:

The total annual burden is estimated to be about 47,032 hours3.703704e-4 days 0.00889 hours 5.291005e-5 weeks 1.2176e-5 months per year for the 5,529 licensees covered by 10 CFR Part 30. The details are shown in Tables 1 and 2. The total cost for the NRC licensees would be 20,381 hours0.00441 days 0.106 hours 6.299603e-4 weeks 1.449705e-4 months x $63/ hour, or $1,284,003, for Sections 30.41(c and d) and 30.51, plus 26,556 hours0.00644 days 0.154 hours 9.193122e-4 weeks 2.11558e-4 months x $140/ hour, or $3,717,840, for the other reporting and recordkeeping requirements, giving a total cost burden of $5,001,843.

Aareement State Licensees:

The total annual burden is estimated to be 111,753 hours0.00872 days 0.209 hours 0.00125 weeks 2.865165e-4 months per year for the approximately 16,000 Agreement State licensees. The details are shown in Tables 3 and 4. The total cost for the Agreement State licensees would be 58,230 hours0.00266 days 0.0639 hours 3.80291e-4 weeks 8.7515e-5 months x $63/ hour, or $3,668,490, for Sections 30.41(c and d) and 30.51, plus 53,523 hours0.00605 days 0.145 hours 8.647487e-4 weeks 1.990015e-4 months x $140/ hour, or $7,493,220, for the other reporting and recordkeeping requirements, giving a total cost burden of

$11,161,710.

l The total annual burden for both NRC and the Agreement States is 158,785 hours0.00909 days 0.218 hours 0.0013 weeks 2.986925e-4 months .

l l

13.

Estimate of Other Additional Costs None. For licensees under 10 CFR Part 30, it is most likely that purchases of equipment and 15

l services were made (1) prior to October 1,1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

14.

Estirnated Annualized Cost to the Federal Government The annual cost for the NRC to review the records and reports required by 10 CFR Part 30 is estimated to be 9,834 hours0.00965 days 0.232 hours 0.00138 weeks 3.17337e-4 months x $140/ hour, or $1,376,760. This cost can be broken down into:

7,609 hours0.00705 days 0.169 hours 0.00101 weeks 2.317245e-4 months , or $1,065,260, for review of the reports submitted to NRC; and 2,225 hours0.0026 days 0.0625 hours 3.720238e-4 weeks 8.56125e-5 months , or

$311,500, for review of the records during inspections. The majority of the cost for review of reports is associated with review of the decommissioning funding plans and decommissioning plans, which account for 5,539 hours0.00624 days 0.15 hours 8.912037e-4 weeks 2.050895e-4 months , or $775,460. In addition, technical assistance contracts for review of these plans are estimated at $200,000. Therefore, the total estimated annualized cost to the Federal government for the 10 CFR Part 30 information collection requirements is approximately $1,576,760. Application review activities for 10 CFR Part 30 licensees are attributed to and reported under OMB Clearance No. 3150-0120 for NRC Form 313. The burden of certifying the disposition of alllicensed material, including accumulated wastes, required for termination of 10 CFR Part 30 licenses is reported under OMB Clearance No. 3150-0028 for NRC Form 314. These costs are fully recovered through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and/or 171.

15.

Reasons for Chanaes in Burden or Cost The overall burden has increased due to an increase in the recordkeeping burden for Agreement State licenses under 30.51. The number of licensees increased from 12,178 to 16,000 with a corresponding burden increase of 13,377 hours0.00436 days 0.105 hours 6.233466e-4 weeks 1.434485e-4 months . There was a decrease in NRC licensees for 30.51 from 6,089 to 5,529 with a corresponding burden decrease of 1,960 hours0.0111 days 0.267 hours 0.00159 weeks 3.6528e-4 months .

The overall result is a burden increase of 11,512 hours0.00593 days 0.142 hours 8.465608e-4 weeks 1.94816e-4 months . The number of responses increased due to the capturing of recordkeepers for the first time.

16.

Publication for Statistical Use There is no application to statistics in the information collected. There are no plans fcr publication of this information.

17.

Reason for Not Displavina the Expiration Date The requirements are contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become obsolete would be unduty burdensome and too difficult to keep current.

16

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18.

Exceptions to the Certification Statement There are no exceptions.

8.

COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Not applicable.

l 1

I 17

I i

Table 1. Part 30 Reporting Burden for NRC Licensees

~

Licensee Total Annual No. of Licensee Staff Hours Licensee Burden Section Responses Annually Per Submittal (Hrs) 30.9(b) 9 1

9 30.11 20 5

100 30.15(b)

Burden is covered under OMB Clearance No. 3150-0120 30.18(d)

Burden is covered under OMB Clearance No. 3150-0120 30.19(b)

Burden is covered under OMB Clearance No. 3150-0120 30.20(b)

Burden is covered under OMB Clearance No. 3150-0120 30.32(a)

Burden is covered under OMB Clearance No. 3150-0120 30.32(b)

Burden is covered unde.- OMB Clearance No. 3150-0120 30.32(f)

Burden is covered under OMB Clearance No. 3150-0021 30.32(g)

Burden is covered under OMB Clearance No. 3150-0001 30.34(e)(4)

Burden is covered under individual clearance requests that are submitted as needed.

30.34(h) 10 0.5 5

30.35 Certification 50 100 5,000 Funding Plan 15 300 4,500 30.36(b)(2)(ii) 10 6

60 30.56(d) 390 1

390 30.36(e)

Burden is included in 6 30.35.

30.36(g) 25 360 9,000 l

l 18

g

Table 1. Part 30 Reporting Burden for NRC Licensees (continued) 30.36(i)

Burden is covered under OMB Clearance No. 3150-0028 30.37(a)

Burden is covered under OMB Clearance No. 3150-0120 30.38 Burden is covered under OMB Clearance No. 3150-0120 30.50 70 4

280 30.55(c) 2 10 20 Appendix A Burden is included in 9 30.35 Appendix C Burden is included in 30.35 Appendix D 4

1 4

Appendix E 91 1

91 Total Annually Reporting 696 19,459 Hours t

19

m-t Table 2. Part 30 R.ecordkeeping Burden for NRC Licensees l

Annual Hours Total No. of per Recordkeeping Section Recordkeepers Recordkeeper Hours 30.34(g) 92 17.3 1,592 30.35(g) 560 10.0 5,600 30.41(c) & (d) 294 3.5 1,029 30.51 5,529 3.5 19,352 Total Number of Recordkeepers:

5,529 Total Recordkeeping Hours Annually:

27,573 TOTAL ANNUAL BURDEN HOURS:

47,032 20

p e

Table 3. Part 30 Equivalency Reporting Burden for Agreement State Licensees Licensee Total Annual No. of Licensee Staff Hours Licensee Burden Section Responses Annually Per Submittal (Hrs) 30.9(b) 18 1

18 30.11 40 5

200 30.32(a)

Burden is covered under OMB Clearance No. 3150-0120 30.32(b).

Burden is covered under OMB Clearance No. 3150-0120 30.32(f)

Burden is covered under OMB Clearance No. 3150-0021 30.32(g)

Burden is covered under OMB Clearance Na. 3150-0001

- 30.34(e)(4)

Burden is covered under individual clearance requests that are submitted as needed.

30.34(h) 20 0.5 10 30.35 Certification 100 100 10,000 Funding Plan 30 300 9,000 30.36(b)(2)(ii) 20 6

120 30.36(d) 780 1

780 30.36(e)

Burden is included in S 30.35 30.38(g) 50 360 18,000 30.36(j)

Burden is covered under OMB Clearance No. 3150-0028 21

r-f.

i l

Table 3. Part 30 Equivalency Reporting Burden for Agreement State Licensees

~~ (continued) i i

30.37(a)

Burden is covered under OMB Clearance No. 3150-0120 30.38 Burden is covered under OMB Clearance No. 3150-0120 30.'50 54 4

216 Appendix A Burden is included in 30.35 Appendix C Burden is included in S 30.35 Total Renorting 1,112 38,344 l

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Table 4. Part 30 Equivalency Recordkeeping Burden for Agreement State Licensees Annual Hours Total No. of per Recordkeeping

. Section Recordkeepers Becordkeeper Hours 30.34(g) 230 17.3 3,979 30.35(g) 1,120 10.0 11,200 30.41(c) & (d) 637 3.5 2,230 30.51 16,000 3.5 56,000 Total Number of Recordkeepers:

16,000 Total Recordkeeping Hours Annually:

73,409 TOTAL ANNUAL BURDEN HOURS:

111,753 TOTAL ANNUAL BURDEN HOURS 158,785 FOR NRC AND AGREEMENT STATES:

1 23

ML20210E282

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