FINAL OMB SUPPORTING STATEMENT
FOR
NRC FORM 4
CUMULATIVE OCCUPATIONAL DOSE HISTORY
(3150-0005)
EXTENSION
Description of the Information Collection
The purpose of Title 10 of the Code of Federal Regulations Part 20 (10 CFR Part 20) is to establish “Standards for Protection Against Radiation.” 10 CFR Part 20 provides requirements for persons licensed by the U.S. Nuclear Regulatory Commission (NRC) to receive, possess, use, transfer, or dispose of byproduct, source, or special nuclear material or to operate a production or utilization facility under parts 30 through 36, 39, 40, 50, 52, 60, 61, 63, 70, or 72. In addition, 10 CFR Part 20 applies to persons required to obtain a certificate of compliance or an approved compliance plan under 10 CFR Part 76.
Pursuant to 10 CFR 20.1502, licensees are required to monitor exposures to radiation and radioactive material at levels to demonstrate compliance with the occupational dose limits in 10 CFR 20.1201. 10 CFR 20.2104 requires licensees to determine the occupational radiation dose received by an individual who required monitoring under 10 CFR 20.1502 during the current year. To comply with these requirements, the licensee may accept a written signed statement from the individual or from the individual’s most recent employer as a record of the occupational dose that the individual received during the current year. The licensee may also accept an up-to-date NRC Form 4, “Cumulative Occupational Dose History,” or its equivalent as a record of cumulative radiation dose The NRC Form 4 is a summation of the NRC Form 5, “Occupational Dose Record For A Monitoring Period”. The NRC Form 4 should be signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual’s current employer (if the individual is not employed by the licensee).
JUSTIFICATION
Need for and Practical Utility of the Information Collection
10 CFR 20.2104 requires licensees to determine an individual’s prior occupational dose. As specified in Section 20.2104(c), licensees may obtain this information through several methods. Section 20.2104(d) requires licensees to record an individual’s prior occupational dose on an NRC Form 4, or its equivalent, and this record must show each period in which the individual received occupational exposure to radiation or radioactive material and must be signed by the individual who received the exposure. The data contained in NRC Form 4, or its equivalent, can be reviewed by NRC inspectors to determine compliance with the annual dose limits in 10 CFR 20.1201 to ensure the health and safety of licensee employees.
In addition, Section 20.2104(f) requires licensees to retain the NRC Form 4 records, or its equivalent, until the Commission terminates the license.
The NRC Form 4 information collection is based, in part, on Presidential Guidance to Federal Agencies for Occupational Exposure published in the Federal Register on January 27, 1987. NRC Form 4 is a cumulative summary of the information found on NRC Form 5, which is submitted by NRC licensees annually pursuant to 10 CFR 20.2206.
2. Agency Use of Information
The NRC uses the information to ensure that licensees are complying with the appropriate regulations, specified in 10 CFR 20.1502 and 10 CFR 20.2104 and their license conditions in order to protect the health and safety of occupational radiation workers and the public.
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. NRC issued a regulation on October 10, 2003 (68 FR 58791), consistent with the Government Paperwork Elimination Act, which allows its licensees, vendors, applicants, and members of the public the option to make submissions electronically via CD-ROM, e-mail, special Web-based interface, or other means. It is estimated that approximately 95% of the requests for NRC Form 4 information are filed electronically.
The NRC Form 4 is not required to be submitted to the NRC. However, NRC licensees provide this form to their occupational radiation workers who were monitored pursuant to 10 CFR 20.1502.
Regulatory Guide 8.7, Revision 3, (November 2016), “Instructions for Recording and Reporting Occupational Radiation Dose Data,” provides licensees with guidance regarding the recommended format for both paper and electronic submission of occupational radiation dose data. The electronic reporting guidance provided in this document is intended to reduce the reporting burden on licensees. In addition, the NRC-supplied software, Radiation Exposure Management Information Transmittal (REMIT) is available to licensees at no cost. Licensees with Internet access may download this software free of charge from the NRC's Radiation Exposure Information and Reporting System (REIRS) Web site at http://www.reirs.com. This software vastly reduces the burden of collecting and maintaining occupational radiation dose information and allows licensees to generate the NRC Form 4.
In addition, NRC has an automated dose history request form on the REIRS Web site that allows individuals and organizations to request a cumulative dose history report, or NRC Form 4, for individuals monitored at NRC facilities. The automated request form is another paperwork reduction feature. A requestor electronically submits a request and a NRC Form 4 report is sent via an encrypted email.
4. Effort to Identify Duplication and Use Similar Information
No sources of similar information are available. There is no duplication of requirements.
5. Effort to Reduce Small Business Burden
NRC’s development and maintenance of the REMIT software is a direct effort to reduce the burden on small businesses. REMIT is also used by large businesses o help reduce their paperwork burden. NRC provides the REMIT software, at no cost, to all licensees (both small and large firms) to assist them in their recording, reporting, and maintenance of occupational radiation exposure data. In addition, the automated dose history request option, available on the REIRS Web site is particularly beneficial to small businesses that may not have the resources to obtain prior dose histories for their occupational radiation workers. It is not possible to reduce the burden on small businesses any further and still meet the objectives stated in A.1.
6. Consequences to Federal Program Activities if the Collection is not Conducted or is Conducted Less Frequently
If the requirements of 10 CFR 20.2104 were not met by licensees, licensees would not be knowledgeable of an occupational worker’s prior radiation exposure. A lack of knowing this information could lead to an occupational radiation worker receiving a radiation exposure in excess of the limits specified in 10 CFR 20.1201 for the current year. This lack of information could result in non-compliance by a licensee.
7. Circumstances Which Justify Variation from OMB Guidelines
Records associated with the NRC Form 4 must be retained for the life of the NRC license in accordance with Section 20.2104(f).
8. Consultations Outside the NRC
Opportunity for public comment on the information collection requirements for this clearance package has been published in the Federal Register on March 28, 2017 (82 FR 15376). NRC contacted four licensees through email and no comment was received. There was one comment received from the general public.
Commenter: I wish to oppose this existing information collection because it fulfills no useful purpose. Creating paper for inspectors to inspect is not a useful purpose. The NRC does not collect the information and use it for any legitimate purpose.
NRC Response:
It is correct that NRC does not collect the information on the NRC Form 4. The form is provided for licensees to use for the purposes of recording an individual’s cumulative occupational exposure history when required. A cumulative occupational exposure history is required prior to an individual participating in a Planned Special Exposure in accordance with 10 CFR 20.2104.
The individual or the licensee may use a record that is equivalent to Form 4, as long as all of the necessary information is provided.
Commenter: As to your specific questions:
1. ls the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
Commenter: The information is not collected by the NRC. The information has no practical utility and the NRC does not use it for any scientific purpose. One cannot use these data to look at carcinogenesis as a function of cumulative radiation absorbed dose, for example, because it does not include all sources of radiation to which the worker has been exposed. Background radiation and medical radiation are not included, nor is radiation from volunteering in research projects. If this information collection were to be discontinued, the licensee would still have to report occupational radiation overdoses, so the information collection does not contribute to the proper performance of NRC s functions.
NRC Response:
The purpose of the Form 4 is to record the information required by 10 CFR 20.2104 when the cumulative occupational exposure history is required. It is not intended for the other uses indicated here.
The form is for documenting the cumulative occupational exposure history, not other sources of radiation that are non-occupational. “Occupational dose” is defined in 20.1003.
As noted by the commenter, reports of occupational exposures in excess of the limits are required under 20.2203.
2. ls the estimate of the burden of the information collection accurate?
Commenter: I have no information with which to evaluate the burden, but just taking NRC's estimate of 29.350 hours per year of competent radiation scientists’ time for no worthwhile purpose is preposterous and unjustifiably costly.
NRC Response:
The NRC has based the estimate of burden on the time it would take for the NRC Form 4 to be completed if required. A complete breakdown of the estimate of the burden is provided under item 12 in the OMB supporting statement for Form 4.
3. Is there a way to enhance the quality, utility, and clarity of the information collection to be collected?
Commenter: As the information collection has no purpose, its quality, utility, and clarity don’t matter.
NRC Response:
While the information on the Form 4 is not required to be submitted to the NRC, it is required in order for the licensee to satisfy the requirements of 10 CFR 20.1206 (d) prior to an individual being eligible to participate in a Planned Special Exposure.
4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?
Commenter: The burden can be minimized by ending the collection. A burden with no valid purpose is not justifiable. This is a prime example of the sort of junk regulation that the President seeks to end.
NRC Response:
The collection as noted above is still required for a Planned Special Exposure.
Commenter: Thank you for your attention and consideration.
9. Payment or Gifts to Respondents.
Not applicable.
10. Confidentiality of the Information
Confidential and proprietary information is protected in accordance with NRC regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b).
NRC Form 4 specifies the use of the individual's name, social security number or other unique ID, date of birth, and sex. This information is necessary to ensure the proper identification of the individual. There is a Privacy Act System of Records Notice for the NRC’s Radiation Exposure Information and Reporting System (REIRS). The System of Records Notice for REIRS, NRC-27, can be found under http://www.nrc.gov/reading-rm/foia/privacy-act-records.pdf.
11. Justification for Sensitive Questions
This information collection does not involve personally sensitive information.
12. Estimated Burden and Burden Hour Cost
NRC Form 4 is required each time a worker participates in a planned special exposure. The NRC does not anticipate that any workers will participate in a planned special exposure during the clearance period. However, licensees are required to provide each of their employees who have been monitored for radiation exposure, an NRC Form 4 (or equivalent form) at the end of the monitoring year pursuant to 10 CFR 19.13. It takes licensees an estimated 2 minutes (0.03 hours) to print an NRC Form 4 (or equivalent) and provide it to their employees. Therefore, information collected in NRC Form 4 is captured as a third-party disclosure (See Table 1). The estimates presented in Table 1 are based on the 2015 reporting year. Table 1 contains information for 99 reactor sites (licensee data contained in the REIRS database); 96 materials sites (licensee data contained in the REIRS database); and 3,964 materials sites (licensee data not contained in the REIRS database because these licensees are not subject to the reporting requirement in 10 CFR 20.2206(a)). Additionally, copies of an individual’s NRC Form 4 can be requested electronically through the REIRS website--on average, annually 1,550 individuals request records electronically at five minutes per request for a total of 129 hours (at $265/hour) for an additional burden of $34,185.
Below is a breakdown of the numbers presented in Table 1:
Reactors
Number of monitored individuals at 99 reactor sites: 99,427
Number of transient workers at 99 reactor sites: 31,672
Total responses for 99 reactor sites: 131,100
Materials
Number of monitored individuals at 96 materials sites: 10,733
Number of transient workers at 96 materials sites: 246
Total responses for 96 materials sites: 10,979
Materials (not subject to 10 CFR 20.2206(a))
Number of monitored individuals at 3,964 materials sites: 66,237
Number of transient workers at 3,964 materials sites: 8,763
Total responses for 3,964 materials sites: 75,000
In addition to providing an NRC Form 4 (or equivalent) to monitored individuals, licensees continue to complete NRC Form 4 each time a worker changes employment during the year. As a result, the greatest burden is on licensees who employ transient workers. NRC’s Radiation Exposure Information and Reporting System (REIRS) contain information on the number of transient workers at licensee sites that are subject to Section 20.2206(a)1. For the 2015 reporting year, the data show that as of June 2015, 200 sites employed 31,768 transient workers (31,672 transient workers at the 99 reactor sites + 246 transient workers at 96 materials sites). In addition to these sites, some sites are not subject to 20.2206(a) and therefore are not in the REIRS system, but are also voluntarily maintaining NRC Form 4 for their workers. NRC estimates that 3,946 additional materials sites are maintaining NRC Form 4 for 8,763 transient workers. The total number of transient workers at all sites is estimated to be 40,531 (31,768 transient workers at sites with data in the REIRS system + 8,763 transient workers at sites without data in the REIRS system).
With the addition of the new EDEX field, the recordkeeping burden is 0.58 hours to complete, review, and authorize each NRC Form 4. (The previous estimate was .5 hours). The annual burden is 23,508 hours (40,351 workers x 0.58 hours). The annual cost for this requirement is $6,229,615 (at $265/hour). (See Table 2).
The total burden for NRC Form 4, including both third party disclosure, recordkeeping, REIRS website requests is 30,348 hours (23,508 recordkeeping + 6,711 hours third party disclosure + 129 hours for REIRS website retrieval) at a cost of $8,042,220 (30,348 hours x $265/hour).
13. Estimate of Other Additional Cost
The NRC has determined that the quantity of records to be maintained is roughly proportional to the recordkeeping burden and, therefore, can be used to calculate approximate records storage costs. Based on the number of pages maintained for a typical clearance, the records storage cost has been determined to be equal to 0.0004 times the recordkeeping burden cost. Because the recordkeeping burden is estimated to be 23,508 hours, the storage cost for this clearance is $2,492 (23,508 hours x 0.0004 x $265/hour).
14. Estimated Annualized Cost to the Federal Government
NRC cost is incurred by inspectors reviewing the information on NRC Form 4, or its equivalent, and supporting records maintained by licensees. Annually, 99 hours (1 hour/site x 99 reactor sites) of inspection time is spent reviewing such records, at an average of 1 hour for each of the 99 reactor sites. The annual cost for reactor inspectors to review the NRC Form 4, or its equivalent, is $26,235 (99 hours x $265/hour).
There are fluctuations in the number of materials licensees. This fluctuation is mainly due to an increase in the number of Agreement States. Agreement States are those States that have entered into formal agreements with NRC, pursuant to Section 274 of the Atomic Energy Act (AEA), to regulate certain quantities of AEA material at facilities located within their borders. There are currently 37 Agreement States. These 37 Agreement States have regulatory authority over approximately 18,900 materials licensees.
However, NRC is responsible for conducting inspections of NRC Form 4, or its equivalent, and supporting records maintained by 4,042 materials licensees. It is estimated that approximately 404.2 hours (0.1 hour/site x 4,042 materials sites) of inspection time is spent reviewing such records at an average of 0.1 hour for each of the 4,042 materials sites. The annual cost for materials inspectors to review the NRC Form 4 is $107,113 (404.2 hours x $265/hour).
Annually, the total time spent reviewing NRC Form 4, or its equivalent, records is 503.2 hours (99 hours for reactor sites + 404.2 hours for materials sites). The total inspection cost, annually, is approximately $133,348 ($26,235 for reactor inspections + $107,113 for materials inspections) (See Table 3). These costs are fully recoverable through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and 171.
15. Reasons for Change in Burden or Cost
The estimated burden has increased by 12,824 hours from the previous burden of 18,410 hours to 31,234 hours. This increase has three primary reasons: 1) the increase in the number of transient workers, 2) the increase in the burden estimate by 5 minutes based on the inclusion of the EDEX field on the form, and 3) the inclusion of 3rd party disclosure burden for the NRC Form 4.
In addition to the increase in the number of transient workers, licensees provide an NRC Form 4 (or equivalent) to their employees even if the employee has not participated in a planned special exposure (2007 final rule). Licensees provide an NRC Form 4 (or equivalent) to employees pursuant to 10 CFR 19.13.
Due to an increase in the number of transient workers, the number of hours associated with NRC Form 4 is anticipated to be higher in the current renewal cycle than in previous cycles, however, due the shrinking fleet size of licensed reactors this may offset some of these increases.
In the previous clearance (prior to the 2007 final rule), based on REIRS data, NRC estimated that licensees would maintain NRC Form 4, or its equivalent, records for 28,780 transient workers. A review of recent REIRS data shows that as of June 2013, licensees maintained NRC Form 4, or its equivalent, records for an average of 33,518 transient workers annually.
In addition to licensees in the REIRS system, in the current clearance, NRC has included the transient workers employed by 3,946 additional materials licensees. These licensees are not subject to 20.2206(a); therefore, their data is not included in the REIRS system. These licensees were not included in the estimates in the previous clearance; however, NRC inspection findings indicate that these licensees are voluntarily maintaining NRC Form 4 for their workers. The NRC estimates that these licensees are maintaining Form 4 for an additional 8,760 transient workers. The addition of these 3,946 sites to the estimates has greatly increased the estimated number of respondents.
The second reason for the increase in the estimated burden is an increase in the estimated time to complete NRC Form 4, from 30 minutes to 35 minutes. Prior to the 2007 final rule, the estimate to complete NRC Form 4 was 30 minutes. Because it takes less time to complete NRC Form 4 for a planned special exposure, the burden was reduced to 15 minutes. However, because licensees primarily use the NRC Form 4 to record an employee’s cumulative exposure, the burden estimate was changed to 30 minutes. The burden estimate has changed from 30 minutes to 35 minutes to include the new “EDEX” field. The addition of this field is needed so that licensees can comply with the definition of the total effective dose equivalent (TEDE) in 10 CFR 20.1003. The change in TEDE definition was part of the December 2007 final rule on 10 CFR Parts 19, 20, and 50 (72 FR 68043).
Finally, in addition to taking 35 minutes to complete the NRC Form 4, in this renewal, an additional 2 minutes per worker has been added to account for the time spent by licensees to provide a copy of the NRC Form 4 to their workers. The NRC staff estimates that licensees use an additional 2 minutes to print the form (or its equivalent) and provide it to their employees. This resulted in an additional 6,711 hours for this clearance.
It should be noted that the NRC does not anticipate any planned special exposures during the next three years; therefore, all licensees that use the NRC Form 4 for the next three years will be on a voluntary basis.
16. Publication for Statistical Use
NRC Form 4 is not published for statistical use.
17. Reason for Not Displaying the Expiration Date.
The requirement will be contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become out of date would confuse the public.
18. Exceptions to the Certification Statement.
Not applicable.
B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
Statistical methods are not employed in the collection of information.
TABLE 1
THIRD-PARTY DISCLOSURE FOR NRC FORM 4 – RECORD PROVIDED TO MONITORED INDIVIDUALS
NUMBER OF RESPONDENTS |
RESPONSES PER RESPONDENT |
TOTAL RESPONSES |
BURDEN PER RESPONSES (hours) |
TOTAL BURDEN (hours) |
|
Reactors |
99 |
1,324.24 |
131,100 |
0.03 |
3933
|
Materials - data from REIRS |
96 |
114.36 |
10,979 |
0.03 |
329.37 |
Materials - licensees not subject to 20.2206(a), no REIRS data |
3,946 |
19.01 |
75,000 |
0.03 |
2,250 |
REIRS Website Requests |
1550 |
1 |
1550 |
0.083 |
129 |
Totals |
4,146 |
|
223,700 |
|
6,641.37 |
TABLE 2
RECORDKEEPING BURDEN ASSOCIATED WITH NRC FORM 4
NUMBER OF RECORDKEEPERS |
NUMBER OF RECORDS/ RECORDKEEPERS |
NUMBER OF RECORDS |
BURDEN HOURS/ RECORDS |
ANNUAL BURDEN HOURS |
ANNUAL COST@ $265/HR |
|
Reactors |
99 |
304.5 |
30,149 |
0.58 |
17,486.64 |
$4,633,960 |
Materials - data from REIRS |
96 |
2.56 |
246 |
0.58 |
142.68 |
$37,810.20 |
Materials - licensees not subject to 20.2206(a), no REIRS data |
3,946 |
2.22 |
8,763 |
0.58 |
5,082.54 |
$1,346,873.10 |
Totals |
4,141 |
|
39,158 |
|
22,712 |
$6,018,642.90 |
TABLE 3
ESTIMATED ANNUALIZED COST TO THE NRC FOR REVIEW OF REPORTS AND INSPECTIONS ASSOCIATED WITH NRC FORM 4
NUMBER OF RESPONDENTS |
STAFF HOURS PER LICENSEE |
STAFF BURDEN HOURS |
ANNUAL COST@ $265/HR |
|
Reactors |
99 |
1.0 |
99 |
$26,235 |
Materials |
4,042 |
0.1 |
404.2 |
$107,113.40 |
Totals |
4,146 |
|
503.2 |
$133,348.40 |
1 Data in the REIRS system is based on other approved NRC information collections, such as NRC Form 5,
3150-0006
| File Type | application/msword |
| Author | DEL1 |
| Last Modified By | Majeed, Fajr |
| File Modified | 2017-06-30 |
| File Created | 2017-06-30 |