ML20196D548

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Request for OMB Review & Supporting Statement Re 10CFR31, General Domestic Licenses for Byproduct Matl. Estimated Respondent Burden Is 7,899 H
ML20196D548
Person / Time
Issue date: 11/05/1998
From: Shelton B
NRC
To:
Shared Package
ML20196D536 List:
References
OMB-3150-0016, OMB-3150-16, NUDOCS 9812020274
Download: ML20196D548 (8)


Text

' Please're d the instructions befora comp'; ting this form. Fcr addition:1 forms er assistr.nce in compliting this form, contict your Support cg:ing Stit:mont End cny cdditionti docum:nt: tionOffica to:ncy's cf P;perwork Infarmttiin Cl:er:nce cnd R!culsttryOfficir. S;nd Offica Aff;lrs, two copitscf cf this form Managem2nt cnd (Judget, Docket Library, Riom 10102,72517th Street NW, W:shingtrn, DC 20503.

1. Agency / Subagency orginating request 2. OMB control number U.S. Nuclear Regulatory Commission y a. 3150-0016 b.None
3. Type of informaten coneccon (check one) . 4. Type of review requested (check 000)
a. New collection y a. Regular c. Delsgated g b. Revision of a cunently approved collection b. Emergency Approval requested by (date):
c. Extension of a cunently approved couschon 5. Wili this information collection have a a.Yes

~ significant economic impact on a -

substantial number of small entities?

d. couection Remetatement,hich for w approval ifas expiredwithout change, of a previously approved Y b' N0
e. ush appmved

,egyga p p g a.Three years from approval date

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f. Existing conection in use without an OMB control number 7 b. Other (Specify): 6/30/1999
7. Title 10 CFR 31, General Domestic Licenses for Byproduct Material 8 Agency form number (s) (if apptca6Je)

N/A I

e. Keywords Byproduct Material, Rad!ation Protection, Reporting and Recordkeeping Requirements
10. Abstract Proposed Rule 10 CFR 31.5, Requirements for the Possession ofIndustrial Devices Containing Byproduct Mat: rial is being amended to add new requirements. General licensees will be required to respond within 30 d ys to NRC's request for information concerning products that the licensee received under a generallicense.

3 Affected public (new*eme,y man gasoms,s metasetymm x > gobhgaten to respond (more emery unn v eare amers met meery mm x >

a. Individuals or households d. Farms a Voluntary

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T b. Business or other for-profit T e. Federal Govemment b. Required to obtain or retain benefits T c. Not-for-profit institutions T f. State, Local or Tribal GovemfremT c. Mandatory

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13. Annual reporting and recordkeeping hour burden 14. Annual reporting and recordkeeping cost burden emousenaisoroosers;
s. Number of respondents 30,378 s. Total annualized capital /startup costs 0
b. Total annual responses o10 b. Total annual costs (oa,M)
1. Percentage of these responses c. Total annualized cost requested 0 conoceed electronicany 0.0  % d. cunent OMB inventory
c. Total annual hours requested 7,899 e Difference 0
f. Explanation of difference
o. Difference 0
1. Program change
f. Explanadon of h
1. Program change 2. Adjustment
2. Adjustment
15. Purpose of informaten conecten 16. Frequency of recordkeeping or reporting (check s# ther apply)

(seers pnmary * 'P"and af oWiers that appfi r weh "M a. Recordkeeping b. Third-party disclosure l

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c. Application for benefits e. Program planning or management c. Reporting

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b. Program evaluation
c. General purpose statisucs T
f. Research
g. Reguistory or compliance

] 1. On occasion

4. Quartetty

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2. Weekly
5. Semi-annually

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3. Monthly
6. Annually

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d. Audit 7. Biennially 8. Other (describe)
17. 5tetencet methods 18. Agency contact (person who con best answer quespons regardeg me Does this informaten coNection employ statistical methods?

Name: Jayne McCausland Yes-  % No Phone: 301-415-6219 oggs 831 me vann es snee uoms warme 10/95 9812O20274 981105 PDR ORO EUSOM8 PDR

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19.C:rtifis'ti:n f:r P perw:rk Reductisn Act Submi=isna (

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! On behalf of this Federal agency,I certify that the collection ofinformation encompassed by this request complies wiJh 5 CFR 1320.9.

i NOTE: De text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8 (b)(3), appear at the end of the instructions. The certification is to be made with reference to those regulatoryprovisions as setfbrth in the instructions.

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' ne 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 unnecessary 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):

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

(v) Nature of extent of confidentiality; and (vi) Need to display currently valid OMB control number;.

(h) It was developed by an office that has planned and allocated resources for the efficient and effective manage-(i) E*u"sesNE6N!!NcTe!YSE$tkaiShnN880Yofy';Y

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(j) It makes appropriate use ofinformation technology.

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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.

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4 Signature of Authorned Agency Ofrost Date

' Date  ;

Signature of Sener Ofrael or Oos' l

.( A. L Sheferi,

, OfRce of the Chief Information Officer ll fI  !

_ =_

WW " 10/95

l k . 4 OMB SUPPORTING STATEMENT FOR PROPOSED RULE 10 CFR PART 31 REQUIREMENTS FOR THOSE WHO POSSESS CERTAIN INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL TO PROVIDE REQUESTED INFORMATION Descriotion of the Information Collection in 1959, the Atomic Energy Commission amended its regulations to provide a general license to possess and use byproduct material contained in certain luminous, measuring, gauging, and controlling devices producing light or emitting radiation. Under the conditions for a general license, certain persons may receive and use a device containing byproduct materialif the device has been manufactured and distributed in accordance with the specifications contained in a specific license issued by the NRC or by an Agreement State pursuant to 10 CFR Parts 30 and 32.

The general licensee is required to comply with the safety instructions contained in or l referenced on the label of the device and to have the testing or servicing of the device performed by the supplier or other specific licensee authorized to manufacture, install, or service such devices. A generally licensed device is a " black box" that usually consists of radioactive material, contained in a sealed source, within a shielded device. The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. Thus, the general license is meant to simplify the licensing process so that a case-by case determination of the adequacy of the radiation training or experience of each user is not necessary.

In the past, general licensees have not been contacted by the NRC on a regular basis because of the relatively small radiation risk compared to the risk of other specifically licensed installations. These devices have survived fires and explosions on many occasions without a totalloss of shielding. They have been damaged by molten steel and hit by construction vehicles with only minor losses in radiation shielding while maintaining the integrity of the source capsule. However, there have been a number of occurrences involving generally licensed devices that suggest that better accounting for such devices may be beneficial. For example, one or more cesium-type gauges were mixed in with some scrap metal that was smelted to form steel and the entire batch of steel was contaminated. In another instance, a static eliminator bar with 22.5 millicurie of americium-241 was sent to a sanitary landfill. There have been other types of incidents involving NRC generally licensed devices including overexposure, damaged devices, leaking or contaminated sources, and equipment malfunctions. However, loss of accountability remains the most common problem and the predominant concem.

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in consideration of incidents like those noted above, the NRC conducted a 3-year sampling (1984 through 1986) of generallicensees to determine whether there was an accounting problem with generally licensed device users, and if so, what remedial action could be taken.

On the basis of this 3-year General License Study, the NRC concluded that there is 1) a lack of awareness of appropriate regulations on the part of the user and 2) an inadequate handling and accounting for these licensed devices. The NRC further concluded that these two problems can be remedied by more frequent and timely contact between the general licensee and the NRC.

A. JUSTIFICATION in order to correct the types of problems discussed above,10 CFR Part 31 is being amended.

10 CFR 31.5(c) would be amended to require general licensees to verify compliance with certain conditions imposed by the generallicense. This would ensure that certain general licensees are aware of and understand the requirements attendant to the possession of generally licensed devices containing byproduct material and to better enable the NRC to verify the location, use, and disposition of such devices. The intent is to reduce the possibility of the devices being improperly transferred or inadvertently discarded, and ultimately to avoid unnecessary radiation exposure to the public and unnecessary expense involved in retrieving the items, particularly in the scrap metal stream as well as to avoid the contamination of steel mills, metals, and waste products.

A new suboaraaraoh (11) to 10 CFR 31.5(c) would require general licensees to respond, within 30 days or otherwise specified time, to requests from the NRC to verify data already held by NRC relating to the general license and the general licensee. The licensee can request an extension if he or she is having difficulty in providing the information. Requests by NRC for verification would be made which provide the information currently on record conceming devices containing byproduct material which have been transferred to the generallicensee. The general licensee would verify, correct, and add to the information as necessary, and report on the disposition of devices no longer in the organization's possession. This process would offer greater assurance that a general licensee is informed of his regulatory responsibilities and would provide information from an independent inventory as a mechanism to assist with verifying accountability for devices.

The NRC would make periodic requests (expected to be annual) for verification to remind general licensees of their regulatory responsibilities and to reduce the likelihood that devices containing byproduct material are illegally transferred or inadvertantly discarded.

It should be noted that on December 27,1991 (56 FR 67011), the Commission issued a proposed rule that included similar, though broader, requirements and was approved by OMB. This action replaces the previous proposed rule which is being withdrawn.

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2. Aaency Use of the Information General licensees would be required to verify compliance with certain conditions imposed by the general license. This would better enable the NRC to verify the location, use, and disposition of certain generally licensed devices and reduce the possibility of the devices being improperly transferred or inadvertently discarded, and ultimately avoid unnecessary radiation exposure to the public and unnecessary expense involved in retrieving the items, particularly in the scrap metal stream as well as avoid the contamination of steel mills, metals, and waste products. Also, this would provide the NRC with assurance that the generallicensees are aware of and understand the requirements attendant to the possession of generally licensed devices containing byproduct material.
3. Reduction of Burden Throuah Information Technoloav There are no legal obstacles to reducing the burden associated with this information .

collection requirement through the use of information technology. In fact, the NRC encourages it. However, many licensees typically do not maintain records as required by the regulations on automated equipment. Therefore, the exclusive use of computers for reporting the requested information does not seem practical.

4'. Effort to identifv Duolication and Use Similar Informatign Those licensees covered under 10 CFR Part 32, who initially transfer devices containing byproduct material to generally licensed individuals, are required to submit a written report to the NRC, pursuant to 10 CFR 32.52, identifying each general licensee by name and address, and individual by name and/or position who may constitute a point of contact l between the Commission and the general licensee, the type of the device transferred, and the quantity and type of byproduct material contained in the device. While this is essentially the information that will be requested to be verified and updated by the general licensee, no current requirement would keep the information up to date with changes to location and personnel. Although generallicensees are required to notify the NRC of transfers, they are often not aware of this requirement and do not do so. Also, the registration process is expected to improve general licensees' awareness of responsibilities under this regulation.

5. Effort to Reduce Small Business Burden Because the majority of the general licensees are small businesses, care was taken to require only the minimum amount of information needed in order to assure that the health and safety of the public is being protected. It is not possible to further reduce the burden on small businesses by reducing the information collection or the frequency of the collection.

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6. Consecuences to Federal Proaram or Policy Activities if the Collection is not conducted j or is Conducted Less Frecuentiv

! It is not possible to report less frequently. Should the requested information not be 4

reported on a periodic basis, there would be less assurance that devices containing

. byproduct material are maintained and transferred properly and not inadvertently discarded, resulting in the less likelihood of adequate protection of the health and safety of I the public.

! 7.' Circumstances Which Justifv Variation From OMB Guidelines I

j. There is no variation from OMB guidelines.

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8. Consultation Outside The NRC Comments are being solicited in the Federal Reoister for this proposed rulemaking.
g. Pavment or Gift to Respondents j l

Not applicable.

' 10. Confidentiality of Information i

! .Not applicable. l l-  !

11. . Justification for Sensitive Questions i

I None.

.12. Estimated Burden and Burden Hour Coat -  !

Approximately 6000 general licensees will respond to written requests from the NRC annually. The average burden per response to these written requests is 20 minutes for an overall estimated annual burden of 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br />. It is estimated that an average of approximately 25 general licensees per year will request an extension. The average burden for each extension request is estimated to be 30 minutes, for an overall estimated annual burden of 121/2 hours. In addition, it is estimated that an average of 100 general licensees per year will be required to respond to various information requests in addition to those submitting registration information under this provision. The average burden per response to special requests is about 30 minutes, for an estimated overall annual burden of approximately 50 hours5.787037e-4 days <br />0.0139 hours <br />8.267196e-5 weeks <br />1.9025e-5 months <br />. The total annual burden and annual burden cost to the industry is estimated to be 2062 hours0.0239 days <br />0.573 hours <br />0.00341 weeks <br />7.84591e-4 months <br />, or approximately $249,500 (2062 hours0.0239 days <br />0.573 hours <br />0.00341 weeks <br />7.84591e-4 months <br /> x $121.00 per hour).

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13. Estimated of Other Additional Costs I

There are no other additional costs. I

14. Estimated Annualized Cost to the Federal Government The estimated annualized cost to the Federal Government as a result of the amendment to 10 CFR 31.5(c)(11) is as follows:

Mailing an initial request for verification of devices to general licensees receiving devices and logging the response into the computerized directory or record that verification has been received would be take approximately 300 hours0.00347 days <br />0.0833 hours <br />4.960317e-4 weeks <br />1.1415e-4 months <br /> (6000 requests @3 minutes per request). The annual cost is approximately $36,300 (300 hours0.00347 days <br />0.0833 hours <br />4.960317e-4 weeks <br />1.1415e-4 months <br /> x $121.00 per hour).

During the initial implementation period, it is estimated that approximately 1800 general licensees will call for technical assistance. Approximately 15 minutes of staff time will be required to respond to about 600 of these technical requests, or 150 hours0.00174 days <br />0.0417 hours <br />2.480159e-4 weeks <br />5.7075e-5 months <br />.

Approximately 30 minutes of staff time will be required to respond to the other 1200 technical requests, or 600 hours0.00694 days <br />0.167 hours <br />9.920635e-4 weeks <br />2.283e-4 months <br />, for a total of 750 hours0.00868 days <br />0.208 hours <br />0.00124 weeks <br />2.85375e-4 months <br />, for the first year or two. The  ;

annual cost for the first two years is approximately $90,750 (750 hours0.00868 days <br />0.208 hours <br />0.00124 weeks <br />2.85375e-4 months <br /> x $121.00 per j hour). After the first two years, the technical assistance requests should drop to approximately 600 requests per year and 15 minutes staff time for each request, or 150 hours0.00174 days <br />0.0417 hours <br />2.480159e-4 weeks <br />5.7075e-5 months <br />, and an estimated annual cost of $18,150 (150 hours0.00174 days <br />0.0417 hours <br />2.480159e-4 weeks <br />5.7075e-5 months <br /> x $121.00 per hour). This )

averages out to approximately $66,550 per year over the first 3 year-period. l An average of approximately 100 miscellaneous one-time requests per year for information from general licensees are anticipated. About 30 minutes per request will be required to send out the request and to review the response, or 50 hours5.787037e-4 days <br />0.0139 hours <br />8.267196e-5 weeks <br />1.9025e-5 months <br /> annually. The annual cost is approximately $6,050 (50 hours5.787037e-4 days <br />0.0139 hours <br />8.267196e-5 weeks <br />1.9025e-5 months <br /> x $121.00 per hour) ,

Approximately 25 requests for extensions are expected per year on average. The time needed to process the requests for extensions is estimated to be 30 minutes per request,  ;

or 121/2 hours. The estimated annual cost is approximately $1,513 (121/2 hours x '

$121.00 per hour). )

The total cost to the Federal Govemment on an annual basis for the first three years is approximately $110,400.

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15. Reasons for Chances in Burden or Cost The increase 'results from modifications to 10 CFR Part 31 that will: require general licensees to respond to a written request from the NRC for verification of devices (6000 responses x 20 minutes = 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br />, allow licensaes to request an extension to the written request (25 responses x 30 minutes = 12.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />), and require licensees to

! respond to additionalinformation requests (100 responses x 30 minutes = 50 hours5.787037e-4 days <br />0.0139 hours <br />8.267196e-5 weeks <br />1.9025e-5 months <br />). The l

total increase will be 2062 hours0.0239 days <br />0.573 hours <br />0.00341 weeks <br />7.84591e-4 months <br /> and 6125 responses.

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16. Publication for Statistical Use None.
17. Egason for not Disolavino the Exoiration Date i

i The requirement will be contained in a regulation. Amending the Code of Federal i- Regulations to display information that, in an annual publication, could become obsolete l would be unduly burdensome and too difficult to keep current.

18 Exceotions to the Certification Statement l

l Not applicable.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS l.

Statistical methods are not used in the collection of information.

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