ML20039A536

Request for OMB Review & Supporting Statement Re 10CFR30. Estimated Respondent Burden Is 36,819-h

ML20039A536
Person / Time
Issue date:	11/24/1981
From:	Donoghue D, Scott R NRC OFFICE OF ADMINISTRATION (ADM)
To:
Shared Package
ML20039A534	List: ML20039A533 ML20039A536
References
NUDOCS 8112180035
Download: ML20039A536 (14)

Text

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RECUEST FOR C>MB REVIEW

~ (Undl ' fh3 Pap:rwork Rcduction Act and Executivo Ord:r 12291)

Im? rtant - Read instructions (SF 33A) before completing this Office of I.-formation and Regulatory Affairs form. Submit the requirednumber of copies of SF 83,together Office of Manygemer.t an't Budget with the matenal for which review is requested to:

Washington. D C. 20503

1. D:partment/ Agency and Bureau / Office originating request 3.Name(s) and telephone number (s) of person (si who can best answer cuestions regarding request U.S. Nuclear Reculatory Commission Pat Woolley (301) 492-8137 2.6-dngit Agency / Bureau number (firstpart of 11 digst Treasury 4.3 digit functional coce flastpart of 11-cigit Treasury Account Account No.)

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$ Tatis ot information Collection or Rulemaking C. ts this a rulerr:aning sucmtssson uncer Section 3504tn) of P L. 96-5117 (Check one)

IM No (Section 3507 sucmission) 10 CFR 30 2 a ves. NPAM. Expecteo date of puolication:

6. A.ts anyinformatron collection (reporting or recorckeeping) 3 0 Yes.tinal rule. Expected date of puchcation:

involved? (Check one)

Effectsve date:

1R Yes and proDosal is attached for review D. At what phase of rulemakingis this submission made?

2 O Yes but DrCoCsalis not attacned - skid to Question D.

3 C No - skip to ouestion O.

ig Not acclicable B. Are the responcents pnmanly educational agencies or 2 o Masor rule.at NPRM stage Institutoons or is the purpose related to Federaleducation 3 0 Masor Final rule for wnscn no NPRM wts published programs ?

4 O Major Final rule. after pubhcation of NP AM O Yes U No 5 C Nonmajor rule.at NPAM sta'ge 6 C Nonmaior rufe. at Final stage COMPLETE SHADED PORTION IF INFORM ATION COLLECTION PftOPOSALIS ATTACHED

7. Current (or former) OMB Number

8. Requested

12. Agency report form number (s)

Expiration Date 3150-0017 N/A Expiration Date

13. Are respondents only Federal agencies?

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17. Abstract-Nicds and Usts (50 words oricss) 10 CFR 30 governs tha application reporting and'.recordkeeping requirements of those licensees using byproduct material.

,18. Rststsd report f ormis) (give OMB numcer(s). IRCN(s).

20. Catalog of Feceral Domestic Assistance Program Number inttinalagency report form number (s) or symbol (s))...., -

N/A

21. Small business or organization IX Yes O No l 19.Typs of af fected public (Check as manyas apply)

22. Type of activity of affected public-indicate 3-digit Standard Indus al ass a on cme (s) (up to W - d over 1 O Individua!s othouseholds 10, check O Multiple or O All 2 O state orlocalgovernments 3 0 farms e El businesses orotherinstitutions (exce$.

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O No CERTIFICATION SY AUTHORIZED OFFICI ALS SU8MITTING REQUEST-ftif y that the informauen Collection er rulemaeung submitted for (Gvi5w 65 neceSSary for the prcper perf ormance Of the agency'S fur'Clions.that Hw prODCSal represents the minimum pubhc burden and Feceral Cost Consistent with rieed. and as Consistent with aCCbCable CMB and agency OChCy cirectives Signature and title Cf:

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Daniel J. Don c, hue R. Stechen Scott

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007 2 6 1991 SUPPORTING STATEMENT FOR APPLICATION, REPORTING, AND RECORDKEEPING REQUIREMENTS IN 10 CFR PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL INTRODUCTION In the Atomic Energy Act of 1954, as amended, Public Law 83-703 (68 Stat. 919), the Congress of the United States made the following finding concerning the development, use,'and control of atomic energy:

"d.

The processing and utilization of... byproduct... material must be regulated in the national interest; and in order to provide for the common defense and security and to protect the health and safety of the public."

The Congress established the means for regulation of byproduct material in section 81 of the Act:

"Sec. 81. Domestic Distribution.

• • • The Commission is authorized to issue general or specific licenses to applicants seeking to use byproduct material for research or development purposes, for medical therapy, -

industrial uses, agricultural uses, or such other useful applications as may be develcped.

• • • The Commission shall not permit the distribution of any byproduct material to any licensee, and shall recall or order the recall of any distributed material from any licensee, who is not equipped to observe or fails to observe such safety standards to protect health as may be established by the Commission or who uses such material in viola-tion of law or regulation of the Commission or in a manner other than as disclosed in the application therefor or approved by the Commissi'on. ***"

Under the above authority, the Commission has issued, amended, and rescinded rules applicable to all persons in the United States governing domestic licensing of byproduct material.

Among those rules are the indi-vidual application, reporting, and recordkeeping requirements set forth below that collectively carry OMB Control Number 3150-0017.

(1) Justification.

(1.1) 10 CFR 30.32(a) imposes a general duty to file an apolication for a byproduct material license in duplicate on an NRC application form either with the Director of Nuclear Material Safety and Safeguards or in person at Commission offices.

10 CFR 30.37 requires that applications for renewal of a specific license be filed in accordance with 10 CFR 30.32.

10 CFR 30.38 requires that applications-for amendment of a license be filed in accordance with 10 CFR 30.32 and requires applicants to specify the respects in which the license is to be amended and the grounds for the amendment.

The justification for the above application requirements is covered in the supporting statements for application forms NRC-313R (OMB Control Number 3150-0023), NRC-313M (OMB Control Number 3150-0041), and NRC-3131 (OMB Control Number 3150-0042).

(1.2) 10 CFR 30.32(b) states that the Commission may at any time after the filing of the original application, and before the

. expiration of the license, require further statements to enable the Commission to determine whether the application should be 4

granted or denied or whether a license should be modified or revoked.

This information requirement is necessary to enable the NRC staff to request additional data and information for applications that are deficient or inadequate to support requests for new, renewed, or amended licenses for byproduct material.

The information requirement also permits the NRC staff to put applicants on notice that submission of an incomplete application will often result in a delay in issuance of the license because of the correspondence necessary to obtain information requested on the application.

The authority for this information requirement is

.dubsection182a.oftheAtomicEnergyActof1954,asamended, which sets out language nearly identical to 10 CFR 30.32(b).

The additional data and information plus supplemental information and information incorporated by reference are all considered by the NRC staff in determining whether an applica-tion meets the requirements of Atomic Energy Act of 1954, as amended, and the regulations of the Commission.

(1.3) 10 CFR 30.32(f) specifies that certain applications for a license to receive and possess byproduct material must be filed 3

at least 9 months prior to commencement of construction of the plant or. facility in which the activity will be conducted and must be accompanied by any environmental report required under 10 CFR Part 51.

The information requirement was added to the Commission's regulations effective March 21, 1972.

It is needed to assure that an opportunity is provided for full consideration of environmental effects before site preparation is begun.

Because site preparation can constitute a key point, from the standpoint of environmental impact, in connection with the licensing of byproduct material, the information requirement enables consideration and balancing of a broader range of realistic alternatives and provides a more significant mechanism for protecting the ervironment during the earlier stages of a project for which a byproduct material license is being sought.

The authority for the information requirement is section 102, National Environmental Policy Act of 1969 2

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(83 Stat. 853) and section 161 of the Atomic Energy Act of 1954, as amended.

(1.4) 10 CFR 30.34(e)4) permits the Commission to incorporate in any license additional requirements and conditions to require reports and the keeping of records as may be necessary to effectuate the purposes of the Atomic Energy Act of 1954,, as amended, and regulations of the Commission.

Although this information requirement imposes no paperwork burden itself, it is cited on those occasions when the NRC has found it necessary to issue orders to modify licenses.

In cases that require licensees to perform an action with concomitant recordkeeping er reporting requirements, the NRC staff files a clearance request for a single-time information -

requirement.

A recent example is the set of orders issued in February 1980 to major byproduct materials licensees requiring them to prepare and submit for NRC review certain information that is needed to assure that adequate onsite planning is made to protect against and to respond to nuclear accidents.

One regulation cited for the recordkeeping and reporting requirements of the orders was 10 CFR 30.34(e).

The NRC sought a General Accounting Office clearance of the recordkeeping and reporting part of the onsite radiological contingency plans (R 0089).

The authority for the information requirement is subsection 1610. of the Atomic Energy Act of 1954, as amended, which among other things ~ authorizes the Commission to require by rule, regulation, or order such reports and the keeping of such records with respect to activities under licenses issued pursuant to section 81 as may be necessary to effectuate the purposes of the Act.

The data is used by the NRC staff to verify that the licensees have performed a required action in a complete,and timely manner.

No similar data would be already available because of the individual nature of the responses.

(1.5) 10 CFR 30.34'(f) requires each specific licensee to notify the Commission in writing when the licensee decides to permanently discentinue all activities involving materials authorized undar the license.

The information requirement was added to the Commission's regulations effective June 5, 1979, to remedy a situation in which the Commission sometimes did not discover that a licensee had discontinued a licensed program, and perhaps had even 3

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O-vacated the premises, until the Commission had conducted an inspection or communicated with the licensee at the end of the

. 5 year license period.

The NRC staff needs to communicate with licensees on a timely basis regarding disposition of byproduct material and cleanup of the facility in which the byproduct material has been possessed and used.

The authority for the information requirement is subsection 1610. of the Atomic Energy Act of 1954, as amended, which among other things authorizes the Commission to require by rule or regulation such reports with respect to activities under licenses issued pursuant to section 81 as may be necessary to effectuate the purposes of the Act.

The notification allows the NRC staff to terminate the byproduct material license in an orderly and timely manner.

No similar data is available because only the licensees can decide to permanently discontinue all activities involving byproduct material authorized under their licenses.

(1.6) 10 CFR 30.34(g) requires each licensee.p/ technetium-99mreparing techne radiopharmaceuticals from molybdenum-99 generators to test the generator eluates for molybdenum-99 breakthrough in accordance with 10 CFR 35.(b)(4)(i) through (iv).

The requirement to perform tests was added to the NRC's regulations effective September 2, 1980, to correct a situation in which therewere no uniform requirements in NRC licenses or regulations or in connection with labeling or package inserts for users 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.

The authority for the requirement is section 81, and subsection 161b. of the Atomic Energy Act of 1954, as amended, that authorizes the Commission to establish by regulation such standards to govern the possession and use of byproduct material as the Commission may deem necessary or desirable to protect health or to minimize danger to life or property.

The requirement to maintain the records for 3 years for Commission inspection permits NRC staff to determine that nuclear pharmacy licensees and broad medical licensees have indeed conducted neulybdenum-99 breakthrough tests on each elution from molybdenum-99/ technetium-99 generators.

Only the requirement to maintain records of the tests is information collection.

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No similar data can be recorded because of the individual nature of each molybdenum-99 breakthrough test.

(1.7) 10 CFR 30.51(a) requires that each licensee who receives byproduct material must keep records showing the receipt, transfer, and disposal of such byproduct material.

Records are necessary as a primary source of docume'ntation 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 rule, 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 in composite 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 authority for the information requirement is subsection 1610. of the Atomic Energy Act of 1954, as amended, which among other things authorizes the Commission to require by. rule or regulation the keeping of such records with respect to activities under licenses issued pursuant to section 81 as may be necessary.to effectuate the purposes of the Act.

The requirement to keep records showing the receipt, transfer, and disposal of byproduct material permits NRC. staff to determine that the licensee has been in compliance with the terms and cunditions of the license and the terms and provi-sions of the Atomic Energy Act and rules, regulations, and orders of the Commission.

No similar data can be recoided because of the individual nature of the recorded events.

(1.8) 10 CFR 30.51(b) requires that records which are required by the regulations in 10 CFR Part 30 through 35 or by license condi-tion must be maintained for the period specified oy the appropriate regulation or license condition.

In any case where a retention period is not specified, the records must be maintained until the Commission authorizes their disposition.

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The information requirement was added to the NRC's regulations effective June 2,1976, to correct a situation in which the Commission's regulations did not specify when an applicant or licensee may dispose of required records.

The j

rule change prescribed tinie periods for applicant and' licensee retention of certain records and provided that, if a retention period is not otherwise specified, those records must be maintained by the applicant or licensee until the Commission authorizes trair disposition.

The authority for the information requirement is section 161 of the Atomic Energy Act of 1954, as amended, which among other things authorizes the Commission to require by rule or regulation the keeping of such records with respect to accivities under licenses issued pursuant to section 81 as may be necessary to effectuate the purposes of the Act.

The retention periods provide reasonable assurance that records will be available for Commission inspection after the recorded event.

The rule change did not change or add to records requirements except with respect to the retention periods.

(1.9) 10 CFR 30.51(c) provides a two year retention period for records of receipt of byproduct material following transfer or disposal, provides a five year retention period for records of transfer of byproduct material, and cross references 10 CFR 20.401(c) which provides that records of disposal of licensed material must be maintained until the Commission authorizes their disposition.

The information requirement was added to the NRC's regulations effective June 2, 1976, to correct a' situation in which 10 CFR Part 30 did not specify when an applicant or licensee may dispose of records concerned with receipt, transfer, or disposal of byproduct material.

The authority for the information requirement is section 161 of the Atomic Energy Act of 1954, as amended, which among other things authorizes the Commission to require by rule or regulation the keeping of such records with respect to activities under licenses issued pursuant to section 81 as may be necessary to effectuate the purposes of the Act.

The information requirement is used oy all specific and general licensees to schedule disposition of records.

(1.10) 10 CFR 30.51(d) provides:

(1) The required records may be either the original or a reproduced copy or microform; and (2) if there is a conflict pertaining to the retention period for the same type of record, the NRC s regulations would be controlling in all cases.

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r The first information requirement was added to the NRC's regulations effective June 2, 1976, to clarify a proposal that only those records which must be maintained pursuant to 10 CFR Part 20 may be maintained in the form of microfilms only. The rule change extended coverage so that records which must be maintained pursuant to 10 CFR Parts 30 through 35 may be the original or a reproduced copy or microform if the reprod,uced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations.

The second information requirement was added to the NRC's regulations effective June 2, 1976, to avoid the need to specify which document would be controlling in the event the documents (regulation, license condition, technical specifi-cation, etc.) provi'de for'different retention periods for the same records.

The~ authority for the information requirement is section 161 of the Atomic Energy Act of 1954, as amended, which among other things authorizes the Commission to require by rule or regulation the keeping of such records with respect to activities under licenses issued pursuant to section 81 as may be necessary to effectuate the purposes of the Act.

The information requirements are used by all specific and general licensees because they must keep records as the original, reproduced copy, or microform.

Individual licensees choose whatever recordkeeping system that best suits their needs.

The time spent by licensees to convert original records to reproduced copy or microform depends on the licensees' per-ception of the space and effort they may save by their recordkeeping system over the retention periods required for the records.

(1.11) 10CFR30.55(b)requireseachlicenseeauthorizedtopossess large quantities of tritium to submit to the Commiss-ion a semiannual statement of the licensee's tritium inventory to the nearest' hundredth of a gram of tritium.

The infor: ration requirement was added to the Ccmmission's regulations. effective June 5,1972, on the basis that it is necessary to provide, within reesonable limits and on a current basis, information needed by the Commission in the interest of the common defense and security of the United States as to inventory quantities of tritium at various lccations in the United States.

The authority for the ir. formation requirement is section 161 of the Atomic Energy Act of 1954, as amended, which among other things authorizes the Commission to establish ay

i rule or regulation such standards and instructions to govern the possession of byproduct material as the Commission may deem necessary or desirable to promote the common defense and security.

The inventory statements are submitted to the Department of Energy as inputs to the U.S. central computer system, the Nuclear Materials Management and Safeguards System (NMMSS),

which is jointly sponsored by the NRC and the Departmer.t.

The system tracks inventory quantities of tritium at various locations through use of a Reporting Identification Symbol (RIS) assigned by the Commission to the licensee.

No similar data is available because only the licensee knows the tritium inventory on March 31 and September 30 of each year.

(1.12) 10 CFR 30.55(c) requires each licensee authorized to possess tritium to report promptly any incident in which an attempt has been made or is believed to have been made to commit a theft or unlawful diversion of tritium.

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The information requirement was added to the Commission's regulations effective June 5, 1972, on the basis it is necessary to provide, within reasonable limits and on a current basis, information needed by the Commission as to thefts or unlawful diversions of :citium.

In the interest of the common defense and security of the United States, the Commission set the reporting limits at more than 10 curies of tritium at any one time ar more than 100 curies of tritium in any one year.

The authority for the information requirement is-section 161 of the Atomic Energy Act of 1954, as amended, which among other things authorizes the Commission to require by rule or regulation such reports with respect to activites under licenses issued pursuant to section 81 as may be necessary to effectuate the purposes of the Act.

The NRC Regional Office staff uses the initial report by telephone and telegraph, mailgram, or facsimile to verify that the licensee has:

(a) checked receipt, transfer, and inventory records to make certain the tritium was received; (b) contacted the final carrier to determine if a bill of lading (was signed showing receipt of the tritium; and (c) conducted or continues l

to conduct) a thorough search and agreed to keep the NRC Regional Office inforr=<i of the licensee's progress.

If the licensee has not already done so, the NRC Regional Office staff may (based on information in the initial and written reports) inform the licensee that it would be appro-I i

priate to notify local authorities, the news media, and the

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v State and include a description of the container (s) of tritium, the hazards in handling, and instructions if found.

A determination to dispatch Regional Office inspectors for purposes of investigation and independent search efforts would generally be based on information in the report' as to the s

perceived impacts.of the stolen or unlawfully diverted tritium i

on the common defense and security of the United States.

The written reports submitted to NRC Regional Offices which set forth the details of the incident, its consequences, and any substantive additional information are duplicate copies of written reports' filed with the Federal Bureau of Irnestigation on the tneft or unlawful diversion of tritium.

(2) Description of the Information Collection.

The potential respondent universe is composed of all persons in the United States who would desire to manufacture, produce, transfer, receive, acquire, own, possess, or use byproduct material as authorized in a specific license or general license issued pursuant to the regulations in 10 CFR Chapter I.

Of the potential respondent universe, about 7000 persons hold specific licenses for which applications have been filed.

The NRC's caseload forecast for the next 3 years is:

Applica-tions for license renewals - 1100 in 1982,1700 in 1983, and 1500 in 1984; applications for amendment of licenses - about 3600 per year; applications for new licenses - 700 in 1982, 850 in 1983, and 850 in 1984.

Applicant / licensee data is compiled and maintained'by the NRC staff in the system 6f records NRC-3, " Byproduct Material License Records - NRC."

System data is indexed by applicant /

licensee name within each State, alphabetically by licensee name within license expiration time periods, and by assigned license number in juxtaposition with licensee name.

(2)(viii)Tabulationandpdblicationolans.

Application information submitted to NRC is used to prepare new licenses, license renewals, and license amendments.

Reportable information provided by licensees is systematically evaluated by NRC staff and is available to the public on request unless tne informat. ion is proprietary or exempt frca disclosure under 10 CFR Part 9, "PUSLIC PECORDS," (OMB Control Number 3150-0043).

(3) Time Schedule for information collection and oublication.

Not applicable.

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i (4) Consultations outside the agency.

On June 26, 1965, the Commission published in the Federal Register (30 FR 8185) a recodification of 10 CFR Part 30 after allowing 30-days public comment on a proposed recodification published December 17, 1964 in the Federal Register (29 FR 17915).

The information requirements in the 1965 version of 10 CFR Part 30 and all subsequent new and amended information require-ments in 10 CFR Part 30 have been (or are currently) the subject of informal rulemaking proceedings under 5 U.S.C. 552 and 553 during which the Commission has considered (or is considering) noblic comments.

(5) Estimate of information collection burden.

See table of burdens and costs.

(6) Sensitive questions.

Not applicable.

NRC application forms carry a Privacy Act Statement pursuant to 5 U.S.C. 552a(e)(3), enacted into law by section 3 of the Privacy Act of 1974 (Ptb. L.93-579).

(7) Estimate of cost to Federal Government'.

AlldirectandindirectcostsincurredbytheNRCinp'roviding special benefits may be recovered by fees.

The term special benefits" includes services rendered at the request of a recipient and all services necessary for the issuance of a required permit, license, approval, or amendment, or other services necessary to assist a recipient in complying with statutory obligations or obligations under the Commission's regulations.

Accordingly, the prescribed fee that applicants and licensees must pay when submitting an application covers the direct and indirect costs of processing an application and issuing a license.

Prescribed fees are set out in 10 CFR 170.31, " Schedule of fees for materials licenses and other regulatory services." Prescribed fees for applications - new licenses, license renewals, and license amendments range from

$40 to $950.

In addition, the prescribed fee that licensees must pay for health and safety inspections covers the direct and indirect costs of each routine inspection performed, including reviews of records.

Prescribed fees are set out in 10 CFR 170.32, " Schedule of fees for health and safety, and safeguards inspections for materials licenses." Prescribed fees for health and safety inspections range from 5200 to.51600 at a maximum frequency ranging from 1 every 10 years to 1 per year.

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e For purposes of estimating " cost to Federal Government,"

the table of burdens and costs includes the direct and indirect costs to the Commission's licensing staff for processing applications and reports and the direct and indirect costs to the Commission's inspection and enforcement staff f;r con-ducting health and safety inspections that include reviews of records.

Because the costs vary considerably for differences in activities, sizes, and complexities of materials licensees covered, the table shows a range of estimated costs to the Federal Government.

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Summary of burdens and costs Cost to Respondents or Reports Annual Hours per Burden Fed. Govt.

Section Recordkeepers

-Annually Responses

Response

(hrs)

($1000)

S30.32(a) 700 1

700 133-665

.630.32(b) 800 1

800 4

3200

$30.32(f) 0 on occasion 0

0 0**

0 0***

0 630.34(a)(4) 0.3 0**

O S30.34(f) 67 O

S30.34(g) 221 52-104 16,575 1/60 269* *** 48 121-627 S30.37 1100 1

1100 S30.38 3600 1

3600 144-468 530.51(a) over 7000 on occasion 1,'000,500 1/30 33'350 770-5,000 530.51(b) over 7000 0

0 0

0 0

S30.51(c) over 7000 0

0 0

0 0

$30.51(d) over 7000 0

0 0

0 0

530.55(b) 10 2

20 25/60 8

~0 530.55(c) 23 on occasion 0

2 0

0 36,819 1,216-6,848

^Burden covered in supporting statement for application forms.

AANo applications or reports filed to date.

Number of respondents, burden and' cost to Federal government r::vered-in clearance requests for single-time information requirement.

• • • • Burden was calculated on the basis of the average number of responses made each year, approximately 78.

b b

e 12

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