Supporting Statement_NIST 366A - 2023 Final

SUPPORTING STATEMENT

U.S. Department of Commerce

National Institute of Standards and Technology

FORM NIST-366A: REQUEST FOR PERSONAL RADIATION

MONITORING SERVICES

OMB Control No. 0693-0086

SUPPORTING STATEMENT PART A

Abstract

NIST maintains radioactive materials licenses with the US Nuclear Regulatory Commission to support the operations of a research nuclear reactor and various laboratories for use of radioactive materials for calibrations and research and development. The activities with licensed radioactive materials require dose monitoring to ensure compliance with limits established in the US Code of Federal Regulations. The database system used at NIST for the collection of personnel and dose information requires the use of certain information to maintain unique records for each individual.

Justification

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

The National Institute of Standards and Technology (NIST) is required by its radioactive materials licensed and 10 CFR 20.1502 and CFR 20.2106 to monitor individuals who may be exposed to ionizing radiation above specific levels. This form will be used to collect information associated with this monitoring and to determine the type of monitoring required. NIST conducts research on materials, physics, biology, chemistry and other scientific disciplines using radiation sources. Individuals may be exposed to this radiation when conducting their research or as part of support services provided at NIST.

10 CFR 20.1502 Citation:

§ 20.1502 Conditions requiring individual monitoring of external and internal occupational dose.

Each licensee shall monitor exposures to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits of this part. As a minimum—

(a) Each licensee shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under the control of the licensee and shall supply and require the use of individual monitoring devices by—

(1) Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in § 20.1201(a),

(2) Minors likely to receive, in 1 year, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of 0.5 rem (5 mSv);

(3) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv);2 and

(4) Individuals entering a high or very high radiation area.

(b) Each licensee shall monitor (see § 20.1204) the occupational intake of radioactive material by and assess the committed effective dose equivalent to—

(1) Adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable ALI(s) in table 1, Columns 1 and 2, of appendix B to §§ 20.1001-20.2402;

(2) Minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.1 rem (1 mSv); and

(3) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 0.1 rem (1 mSv).

[56 FR 23398, May 21, 1991, as amended at 60 FR 20185, Apr. 25, 1995; 63 FR 39482, July 23, 1998]

Citation of § 20.2106 Records of individual monitoring results:

(a) Recordkeeping requirement. Each licensee shall maintain records of doses received by all individuals for whom monitoring was required pursuant to § 20.1502, and records of doses received during planned special exposures, accidents, and emergency conditions. These records5 must include, when applicable—

(1) The deep-dose equivalent to the whole body, lens dose equivalent, shallow-dose equivalent to the skin, and shallow-dose equivalent to the extremities;

(2) The estimated intake of radionuclides (see § 20.1202);

(3) The committed effective dose equivalent assigned to the intake of radionuclides;

(4) The specific information used to assess the committed effective dose equivalent pursuant to § 20.1204(a) and (c), and when required by § 20.1502;

(5) The total effective dose equivalent when required by § 20.1202; and

(6) The total of the deep-dose equivalent and the committed dose to the organ receiving the highest total dose.

(b) Recordkeeping frequency. The licensee shall make entries of the records specified in paragraph (a) of this section at least annually.

(c) Recordkeeping format. The licensee shall maintain the records specified in paragraph (a) of this section on NRC Form 5, in accordance with the instructions for NRC Form 5, or in clear and legible records containing all the information required by NRC Form 5.

(d) Privacy protection. The records required under this section should be protected from public disclosure because of their personal privacy nature. These records are protected by most State privacy laws and, when transferred to the NRC, are protected by the Privacy Act of 1974, Public Law 93-579, 5 U.S.C. 552a, and the Commission's regulations in 10 CFR part 9.

(e) The licensee shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records.

(f) The licensee shall retain the required form or record until the Commission terminates each pertinent license requiring this record. This includes records required under the standards for protection against radiation in effect prior to January 1, 1994.

5 Assessments of dose equivalent and records made using units in effect before the licensee's adoption of this part need not be changed.

[56 FR 23404, May 21, 1991, as amended at 60 FR 20186, Apr. 25, 1995; 63 FR 39483, July 23, 1998]

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

The information will be collected when individuals begin work with radiation sources at NIST. This can include both NIST employees, guest researchers and contractors using NIST facilities. The information will be used by NIST personnel to assign the appropriate radiation dosimetry and to ensure that measured radiation dose is properly recorded. Information will be collected through an electronic fillable, fileable pdf form, or in some cases, a paper form. The NIST 366-A form is only used at NIST and must be collected by NIST as part of Nuclear Regulatory Commission (NRC) license requirements. The information collected is specific to the operations conducted at NIST.

Additionally, NIST is required by 10 CFR 20.2106 to maintain records of radiation exposure monitoring. This form will be used to ensure the exposure information collected is properly associated with the individual using unique identifiers. In addition, NIST must provide reports to the monitored individuals when requested and to the NRC annually.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

The information may be collected on fillable, fileable pdf form or on a handwritten form. The information is then transcribed into a secure database.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

This form is only used at NIST and must be collected by NIST as part of Nuclear Regulatory Commission (NRC) license requirements. The information collected in specific to the operations conducted at NIST.

5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.

This collection does not involve small businesses or other small entities.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

In order to maintain the NIST license (Per NRC requirements), dosimetry information must be recorded. If not, individuals will not be able to work with radiation sources. Critical research could not be conducted at NIST if this information is not collected.

7. Explain any special circumstances that would cause an information collection to be conducted in a manner: requiring respondents to report information to the agency more often than quarterly; requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it; requiring respondents to submit more than an original and two copies of any document; requiring respondents to retain records, other than health, medical, government contract; grant-in-aid, or tax records, for more than three years; in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study; requiring the use of a statistical data classification that has not been reviewed and approved by OMB; that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or requiring respondents to submit proprietary trade secrets, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

The collection will be conducted in a manner consistent with OMB guidelines.

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments. Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years - even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

A 60-day Federal Register Notice soliciting public comments was published on April 4, 2023 (Vol. 88, Number 64, page 19925-19926). No comments were received.

A 30-Day Federal Register Notice soliciting public comments was published on June 27, 2023 (Vol. 88, Number 122, page 41596.

NIST regularly consults with representatives of those from whom information is obtained.

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

No payments or gifts are provided to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy. If the collection requires a systems of records notice (SORN) or privacy impact assessment (PIA), those should be cited and described here.

The form will include the following Privacy Act Statement:

AUTHORITY: The collection of this information is authorized under 10 CFR 20.1502.

PURPOSE: The National Institute for Standards and Technology’s (NIST) mission is to promote U.S. innovation and industrial competitiveness by advancing

measurement science, standards, and technology in ways that enhance economic security and improve our quality of life. NIST is required by 10 CFR 20.1502 to

monitor individuals who may be exposed to ionizing radiation above specific levels. This form will be used to collect information associated with this monitoring and

to determine the type of monitoring required.

ROUTINE USES: NIST will use this information to conduct necessary government business for monitoring radiation exposure at NIST facilities. Disclosure of this

information is permitted under the Privacy Act of 1974 (5 U.S.C. Section 522a) to be shared among NIST staff for work-related purposes. Disclosure of this

information is also subject to all the published routine uses as identified in the Privacy Act System of Records Notices: NIST 5: Nuclear Reactor Operator Licensees

File; NIST 1: NIST Associates (this has a special section for Facility User Records for NCNR).

DISCLOSURE: Furnishing this information is voluntary, however this information is required in order to obtain authorization to work with or around radiation sources

at NIST. The failure to provide accurate information may delay or prevent you from receiving this access. Submitting voluntary information constitutes your consent

to the use of the information for the stated purpose. When you submit the form, you are indicating your voluntary consent for NIST to use of the information you

submit for the purpose stated. This information may also be retained indefinitely as deemed necessary for the purpose of distributing updates and information.

For additional information, see the NIST Privacy Statement/Security Notice.

The information will stored in accordance with NIST privacy act policies and procedures.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

The form does not include any such information.

12. Provide estimates of the hour burden of the collection of information.

It is estimated that the total burden for collection of the information is 150 hours per year. The form takes approximately 15 minutes to complete and is completed approximately 600 times per year. These estimates are based off of response times for typical dosimetry reading.

13. Provide an estimate for the total annual cost burden to respondents or record keepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected on the burden worksheet).

There is no cost to the respondent.

14. Provide estimates of annualized costs to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies may also aggregate cost estimates from Items 12, 13, and 14 in a single table.

The annualized cost to the federal government to collect the information is approximately $500 per year. A technician takes approximately 10 minutes to process each form and processes approximately 600 forms per year. Technician times is estimated to cost $50 per hour.

15. Explain the reasons for any program changes or adjustments reported on the burden

worksheet.

There are no changes or adjustments to this information collection.

16. For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

The results will not be published.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

NIST will display the OMB control number and expiration date on the form.

18. Explain each exception to the topics of the certification statement identified in “Certification or Paperwork Reduction Act Submissions.”

There are no exceptions to this information collection.