ML21256A289
| ML21256A289 | |
| Person / Time | |
|---|---|
| Issue date: | 06/22/2022 |
| From: | Caylee Kenny NRC/NMSS/DREFS |
| To: | |
| Kenny C 301-415-7150 | |
| Shared Package | |
| ML21256A288 | List: |
| References | |
| NRC-2015-0017, OMB 3150-0017, RIN 3150-AJ54 | |
| Download: ML21256A289 (6) | |
Text
SUPPORTING STATEMENT FOR INFORMATION COLLECTIONS CONTAINED IN ITEMS CONTAINING BYPRODUCT MATERIAL INCIDENTAL TO PRODUCTION
PROPOSED RULE
10 CFR PART 30
3150-0017
Description of the Information Collection
The regulatory requirements in Title 10 of the Code of Federal Regulations (CFR) Part 30 identify the information required by the U.S. Nuclear Regulator y Commission (NRC) for an individual or other entity to be licensed to possess, use, or d istribute byproduct material. These requirements specify that the individual or other entity must s ubmit an application that contains the information that will permit the NRC to determine whether t he applicant has training, experience, equipment, facilities, and procedures for the use a nd distribution of byproduct material that are adequate to protect public health and safety. There is no required template for applying for a license; however, the NRC published a series of technical reports (NUREG-1556 series, Consolidated Guidance About Materials Licenses) 1, that may assist applicants in developing their submissions. An applicant may file an applica tion on NRC Form 313, Application for Material License, in accordance with the inst ructions in 10 CFR 30.6, Communications.2 The information collections related to NRC Form 313 are captu red under OMB No. 3150-0120.
The NRC is proposing to amend its regulations in 10 CFR Part 30 to add new § 30.23, Items containing byproduct material incidental to production, specif ic to products containing byproduct material that is not part of the intended end use of the product but instead is present as a result of production. This new section would only apply t o processes that unavoidably result in the incidental addition of byproduct material to the final product. The new section in 10 CFR Part 30 would only apply to those products or materials that have an exempt distribution license under 10 CFR 32.33.
A. JUSTIFICATION
- 1. Need for the Collection of Information
The commitments made by the applicant in the application, as we ll as the information provided as part of the application package, are reviewed by th e NRC staff to determine if the applicant has training, experience, equipment, facilitie s, and procedures for the use and distribution of byproduct material that are adequate to pro tect public health and
1 NUREG-1556 is available on the NRC website at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/.
2 NRC Form 313 is available on the NRC website at http://www.nrc.gov/reading-rm/doc-collections/forms/nrc313.pdf and is approved by OMB under clearance number 3150-0120.
safety. In addition, the information is needed by NRC staff to prepare the license. The license will include the quantity and type of byproduct materia l that will be used, the form of the byproduct material, and will identify the types of activ ities that the licensee will be authorized to perform. When issued, the licenses for possessio n, use, and distribution will include conditions in the license or license conditions. License conditions are specific to the licensee as dictated by that licensees particu lar facilities, equipment, or type of use of material. Some license conditions are applied t o most licensees, and some to certain types of licensees based on the category of use of byproduct material (e.g., radiography, medical use for humans, etc.). These are k nown as established standard license conditions. Established standard license con ditions are utilized by NRC and the Agreement States to ensure that provisions for prot ection of public health and safety are imposed consistently among licensees. They are used in conjunction with the requirements in Chapter I of Title 10 of the Code of Federal Regulations (10 CFR) that the licensee commits to when applying for a licen se. A selection of commonly used standard license conditions that contain reportin g or recordkeeping requirements is described in detail under the description of 10 CFR 30.34(e)(4).
The new technology/uses standard license conditions are imposed on individual licensees and groups of licensees engaged in new materials uses or the use of new technologies in established materials uses. New technology/use s standard license conditions will be utilized by the NRC to ensure that provision s for protection of public health and safety are imposed consistently among licensees. Ne w technology/uses standard license conditions, which contain reporting or recordk eeping requirements similar to those in the regulations and established license con ditions, are described in greater detail in 10 CFR 30.34(e)(4).
After the NRC issues a license, the NRC will ensure that licens ees are performing health and safety inspections. Inspections include review of the lice nsee records related to distribution of byproduct material. These records are needed t o ensure that the licensee is using the byproduct material safely and in accordance with a pplicable NRC regulations. It is the licensees responsibility to ensure it continues to maintain the commitments it made in its application to ensure it fulfills th e regulatory requirements in 10 CFR Part 30.
- 2. Agency Use and Practical Utility of Information
The records that 10 CFR Part 30 requires the licensees to maint ain are reviewed during inspections, license renewals, and license amendment reviews to evaluate compliance with NRC radiation safety requirements for possession and use o f byproduct material.
The records of receipt, transfer, and disposal of byproduct mat erial are reviewed by the NRC inspectors to determine that licensees have confined their possession and use of byproduct material to the locations, purposes, receipt, and qua ntities authorized in their licenses. Reports of significant safety events and theft of ra dioactive material are used by the agency in evaluating the protective actions required to avoid exposures to radiation or releases of radioactive materials that could excee d regulatory limits and, therefore, impact public health and safety, the common defense and security, and the environment.
Bankruptcy reports, decommissioning plans, decommissioning fund ing plans, and certifications of financial assurance for decommissioning are r eviewed by the NRC to
2 ensure that a licensee has adequate procedures and funds for an y necessary cleanup efforts before a licensees responsibility for byproduct materi als is terminated and the site is released for unrestricted use.
- 3. Reduction of Burden Through Information Technology
There are no legal obstacles to reducing the burden associated with this information collection. The NRC encourages respondents to use information technology when it would be beneficial to them.
The NRC has issued Guidance for Electronic Submissions to the NRC, which provides direction for the electronic transmission and submittal of docu ments to the NRC.
Electronic transmission and submittal of documents can be accom plished via the following avenues: the Electronic Information Exchange (EIE) p rocess, which is available from the NRCs Electronic Submittals web page, by O ptical Storage Media (e.g., CD-ROM, DVD), by facsimile, or by email. It is estimate d that approximately 80 percent of the potential responses are filed electronically.
- 4. Effort to Identify Duplication and Use Similar Information
No sources of similar information are available. There is no d uplication of requirements.
- 5. Effort to Reduce Small Business Burden
Most items containing byproduct material incidental to producti on (ICBMIP) end users are small businesses and are ex empt from any reporting, recordkeeping, or accounting and control requirements. To the best of our knowledge, approx imately 10 percent of the ICBMIP licensees (manufacturers and distributors) are small businesses.
- 6. Consequences to Federal Program or Policy Activities if the Collection Is Not Conducted or Is Conducted Less Frequently
If the information is not collected, the NRC will have no way t o assess whether this category of licensee is operating within the radiation safety r equirements applicable to the possession, use, or transfer of byproduct material.
The required reports are collected and evaluated on a continuin g basis as events occur.
Applications for new licenses and each individual license amend ment is submitted only once. Applications for renewal of licenses are usually submitt ed every 15 years.
Information submitted in previous applications may be reference d without being resubmitted. The schedule for collecting the information is th e minimum frequency necessary to assure that licensees will continue to conduct pro grams in a manner that will assure adequate protection of public health and safety.
- 7. Circumstances Which Justify Variation from OMB Guidelines
There are no circumstances which vary from OMB guidelines.
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- 8. Consultations Outside the NRC
Opportunity for public comment on the information collection re quirements for this clearance package has been published in the Federal Register. Any comments related to information collection requirements in the proposed rule wil l be addressed at the final rule stage.
- 9. Payment or Gift to Respondents
Not applicable.
- 10. Confidentiality of Information
Confidential and proprietary information is protected in accord ance with NRC regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b). However, no information normally considered confidential is requested except for proprietary information. Some proprietary information may be included when necessary to provide an adequa te response. An application to withhold such information from public disclosure may be made in accordance with the provisions of § 2.390.
- 11. Justification for Sensitive Questions
This regulation does not request sensitive information.
- 12. Estimated Burden and Burden Hour Cost
This supporting statement provides an estimate of the reporting and recordkeeping burden for 10 CFR Part 30 ICBMIP licensees for the 3-year perio d following the effective date of the rule (assumed to be 2023-2026). The proposed rule would apply to persons who submit an application for an ICBMIP possession license if t he application is submitted after the effective date of this rule.
The burden estimates are based on NRC staff knowledge of the in dustry to make projections for the 3-year period following the effective date of the rule. Based on that staff knowledge of the industry, the NRC anticipates approximat ely nine applications annually for an ICBMIP possession license for the 3-year period following the effective date of the rule.
The burden estimates are based on the numbers of applicants for an ICBMIP possession license that are affected by applicable regulations and estimates of the time necessary to comply with these regulations. The cost to licens ees and applicants is calculated at a rate of $288 per hour for professional staff wh o prepare the technical information submitted in response to the additional cost for th e information collection requirements.
Agreement State Licensees:
Under this rulemaking, the NRC will be issuing all exempt distr ibution licenses; however, for those licensees located in an Agreement State, the Agreemen t State would issue the
4 associated 10 CFR Part 30 posse ssion license. The NRC estimates that all licensees will be located in Agreement States.
The total annual reporting burden is estimated to be 540 hours0.00625 days <br />0.15 hours <br />8.928571e-4 weeks <br />2.0547e-4 months <br /> per year for approximately nine Agreement State licensees that applied for p ossession licenses. The total cost for the Agreement State licensees is expected to be $155,520 (540 hours0.00625 days <br />0.15 hours <br />8.928571e-4 weeks <br />2.0547e-4 months <br /> x
$288/hour).
The total annual recordkeeping burden is estimated to be 45 hou rs per year for approximately nine Agreement State licensees for a total cost o f $12,960 (45 hours5.208333e-4 days <br />0.0125 hours <br />7.440476e-5 weeks <br />1.71225e-5 months <br /> x
$288/hour).
The $288 hourly rate used in the burden estimates is based on t he NRCs fee for hourly rates as noted in 10 CFR 170.20, Average cost per professional staff-hour. For more information on the basis of this rate, see the Revision of Fee Schedules; Fee Recovery for Fiscal Year 2021 (86 FR 32146; June 16, 2021).
Annualized Number of Burden Total Section/Form Description Number of Responses per Total Annual Hours per Annual Cost @
Respondents Respondent Responses Response Burden $288/Hour Hours
REPORTING
10 CFR 30.33 Possession licenses 9 1 9 60 540 $155,520
Annualized Number of Burden Total Section/Form Description Number of Responses per Total Annual Hours per Annual Cost @
Respondents Respondent Responses Response Burden $288/Hour Hours
RECORDKEEPING
10 CFR 30.33 Possession licenses 9 1 9 5 45 $12,960
- 13. Estimate of Other Additional Costs
The NRC has determined that the records storage cost is roughly proportional to the recordkeeping burden cost. Based on a typical clearance, the r ecordkeeping storage cost has been estimated to be equal to 0.0004 percent of the re cordkeeping burden.
Therefore, the additional recordkeeping storage savings for 10 CFR Part 30 is estimated to be $5.18 (45 recordkeeping hours x $288 x 0.0004).
- 14. Estimated Annualized Cost to the Federal Government
There are no estimated annualized cost to the Federal Governmen t, because the burden for reviewing possession licensees will be experienced by the A greement States, not the Federal Government.
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- 15. Reasons for Change in Burden or Cost
There is no change in burden or cost.
- 16. Publication for Statistical Use
This information will not be published for statistical use.
- 17. Reason for Not Displaying the Expiration Date
The recordkeeping and reporting requirements for this informati on collection are associated with regulations and are not submitted on instrument s such as forms or surveys. For this reason, there are no data instruments on whi ch to display an OMB expiration date. Furthermore, amending the regulatory text of the CFR to display information that, in an annual publication could become obsolet e, would be unduly burdensome and too difficult to keep current.
- 18. Exceptions to the Certification Statement
There are no exceptions.
B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS
Not applicable.
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