FINAL FORM 4 SS2007.wpd

FINAL FORM 4 SS2007.wpd

NRC Form 4, Cumulative Occupational Exposure History

OMB: 3150-0005

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FINAL OMB SUPPORTING STATEMENT

FOR

NRC FORM 4

CUMULATIVE OCCUPATIONAL EXPOSURE HISTORY”

(3150-0005)


(Clearance Revision)



Description of the Information Collection

Part 20, Title 10 of the Code of Federal Regulations (10 CFR Part 20), provides requirements to licensees who receive, possess, use, transfer, or dispose of byproduct, source, or special nuclear material or who operate a production or utilization facility under parts 30 though 36, 39, 40, 50, 60, 61, 70, 72 or 76 for compliance with "Standards for Protection Against Radiation." One of the requirements stipulates that the occupational radiation exposure must be recorded by all licensees. Certain categories of NRC licensees are subject to the reporting requirements of 10 CFR 20.2206 and must report radiation exposure for individuals monitored to the NRC on an annual basis.

Pursuant to 10 CFR 20.2104 "Determination of Prior Occupational Dose," for each individual who is likely to receive, in a year, an occupational dose requiring monitoring, the licensee shall 1) determine the occupational radiation dose received during the current year, and 2) attempt to obtain the records of cumulative occupational radiation dose. 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 accept as a record of cumulative radiation dose an up-to-date NRC Form 4, or equivalent. 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).

  1. JUSTIFICATION

    1. Need for and Practical Utility of the Information Collection

The information collection was based, in part, on Presidential Guidance to Federal Agencies for Occupational Exposure published in the Federal Register on January 27, 1987. In order to protect the health and safety of workers, 10 CFR Part 20 requires licensees to control, within specified limits, the occupational radiation dose. NRC Form 4 is to be completed and maintained by NRC licensees until their license is terminated by the Commission. The data contained on the form can be reviewed by the NRC inspectors to determine compliance with the dose-limit requirements of the NRC regulations in order to ensure the health and safety of the licensee employees.

The NRC Form 4 is a cumulative summary of the information found on NRC Form 5's submitted annually by all the licensees for individuals for whom monitoring was provided.

  1. Agency Use of Information

The NRC uses the information to ensure that licensees are complying with the appropriate regulations and their license conditions in order to protect the health and safety of the workers and the public.

  1. Reduction of Burden Through Information Technology

The NRC Form 4 is not required to be submitted to the NRC. It is provided to the radiation workers listing their exposure history. The NRC supplied software, Radiation Exposure Management Information Transmittal (REMIT) is available at no cost to licensees. The NRC provides technical support to users of the REMIT software which allows licensees to generate the NRC Form 4. In addition, the NRC has an automated dose history request form on the Radiation Exposure and Information Reporting System (REIRS) web site (www.reirs.com) to allow individuals and organizations to request a dose history using NRC Form 4 for individuals monitored at NRC facilities. The automated request form reduces the amount of paper needed to submit a request, and the report is sent to the requestor as a password protected e-mail attachment, thereby reducing the paper needed to respond to the request.

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 0% of the potential responses are filed electronically.

  1. Effort to Identify Duplication and Use Similar Information

No sources of similar information are available. There is no duplication of requirements. NRC has in place an ongoing program to examine all information collections with the goal of eliminating all duplication and/or unnecessary information collections.

  1. Effort to Reduce Small Business Burden

The information required by NRC Form 4 is needed for the employees of small businesses as well as for employees of larger business firms to ensure that licensees comply with10 CFR Part 20.2104. The REMIT software was designed to reduce the burden to small businesses in generating and exchanging Form 4’s. The automated dose history available on the REIRS web site is particularly beneficial to small businesses who may not have the resources to obtain prior dose histories. It is not possible to reduce the burden on small businesses any further and still meet the objectives stated in A.1.

  1. Consequences to Federal Program Activities if the Collection is not Conducted or is Conducted Less Frequently

The NRC Form 4 is filled in for an individual at the start of each new employment period. Less frequent collection would mean not checking doses received from previous employment. A worker could receive an occupational dose in excess of the limits of 10 CFR Part 20 if the dose from prior employment during the current year is not considered in assessing the dose a worker could receive during current employment.

  1. 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 order to determine a workers prior occupational radiation dose, as required pursuant to 10 CFR 20.2104.

  1. Consultations Outside the NRC

Opportunity for public comment on the information collection requirements for this clearance package was published in the Federal Register on May 7, 2007, (72 FR 25787). The NRC received one comment letter from Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR) dated July 5, 2007.

a. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does it have practical utility?

Comment: CORAR understands that the data collected is not suitable for epidemiology studies. It was not clear what the value of Form 4 is to the NRC since Form 5 should have all the necessary information to ensure compliance. Also, it is not clear what the value of Form 4 is from a previous employer. New employers only need to know the dose received in the current year and this would be on Form 5.

NRC Response: NRC reviewed the comments as to whether it is substantive and within the scope of the FRN, and determined that it is not within the scope, nor the purpose of the FRN. The epidemiology study was considered to be outside of the scope and is not the purpose of the information collection for either Forms 4 and 5. The occupational dose for employees is an annual as well as collective dose. Both forms are needed for total information content. The licensees are responsible for providing these records, not the employees.

b. Is the burden estimate is accurate?

Comment: CORAR believes the burden estimate appears reasonable and the actual time that licensees spend in preparing reports will vary considerably according to whether they use manual or electronic methods.

NRC Response: NRC is in agreement with the commenter regarding the reasonableness of the burden. Burden estimates are averaged and some licensees may take more or less time to complete forms.

c. Is there is a way to enhance the quality, utility, and clarity of the information to be collected?

Comment: CORAR indicated consideration should be made to develop an NRC central dose registry for occupational exposure to facilitate compliance with 10 CFR 20.2104. This system could be modeled after the Canadian Nuclear Safety Commission Program that maintains an effective national dose registry monitoring occupational exposure. However, there would need to be a means of limiting access of records to the individual to avoid concerns over confidentiality.

NRC Response: NRC reviewed the comment as to whether it is substantive and within the scope of the FRN and determined that it is not within the scope, nor the purpose of this FRN. The concerns about developing a central dose registry is not the purpose of the information collections for either Forms 4 and 5.

d. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology?

Comment: CORAR believes the burden of the information collection could be minimized if the dosimeter processor, licensee, and NRC all used the same electronic reporting system. It would be helpful if reporting by use of the REMIT program would allow entry of data for multiple individuals at one time for a single licensed operation.

NRC Response: NRC reviewed the comment as to whether it is substantive and within the scope of the FRN and determined that the same electronic reporting system REMIT is used for entering multiple individuals.

  1. Payment or Gifts to Respondents.

Not applicable.

  1. Confidentiality of Information

Confidential and proprietary information is protected in accordance with NRC regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b).

  1. Justification for Sensitive Questions

NRC Form 4 specifies the use of the individual's name, social security number or other ID, date of birth, and sex. This information is necessary to ensure the proper identification of the individual.

  1. Estimate of Annual Burden

The requirement to obtain and maintain the information specified on NRC Form 4 for each individual for whom monitoring is required extends to the NRC licensees (104 reactors in commercial operation and about 3,890 NRC materials licensees). Since NRC Form 4 is filled out each time a worker changes employment during the year, the greatest burden is on licensees who utilize transient workers. In 2005, licensees required to submit annual occupational radiation exposure reports in accordance with 10 CFR 20.2206(a), utilized 20,024 transient workers. Of these workers, 19,822 worked at the 104 reactor sites. The other 202 transient workers (20,024 -19,822) worked at 114 materials sites. Approximately, 0.50 hours is required to complete, review and authorize each NRC Form 4. Therefore, there is an annual burden of 9,911 hours for reactor sites, (19,822 transient workers x 0.5 hour/transient worker), and 101 hours for materials licensees (202 transient workers x 0.5 hour/transient worker) for a total annual burden of 10,012 hours. The annual cost to reactor sites for this requirement is $2,150,687 (9,911 hours x $217/hour) and $21,917 (101 hours x $217/hour) for materials licensees. The total annual cost to licensees is $2,172,604 (see Table 1).





  1. Estimate of Other Additional Cost.

The quantity of records to be maintained is roughly proportional to the recordkeeeping burden. 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. Therefore the storage cost for this clearance is estimated to be $1,738 (20,024 hours x $217/hour x 0.0004).

  1. Estimated Annualized Cost to the NRC

NRC cost is incurred by inspectors reviewing the information on NRC Form 4, or its equivalent, and supporting records maintained by licensees. Annually, 104 hours of inspection time is spent reviewing such records for reactor licensees, at an average of 1 hour for each 104 sites. In addition, 389 hours of inspection time is spent reviewing these records for material licensees at an average of 0.1 hours for each of the 3,890 materials licensees. Annually, the total time spent reviewing these records is approximately 493 hours. The annual cost for reactor inspections to review these forms is $22,568 (104 hours x $217/hour) and the annual cost for materials inspections to review these forms is $84,413 (389 hours x $217/hour). Annually the total inspection cost is approximately $106,981 (see Table 2). These costs are fully recovered through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and 171.

  1. Reasons for Change in Burden

The estimated burden has decreased by 2,164 hours from 12,176 hours to 10,012 hours due to the decrease of 4,328 transient workers from 24,352 to 20,024. There was a reduction in the number of materials license recordkeepers from 135 to 114, due primarily to a combination of 2 new Agreement States and the merger, acquisition and business failures of existing materials licenses.

  1. Publication for Statistical Use

None.

  1. 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.

  1. Exceptions to the Certification Statement

Not applicable.

    1. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

Statistical methods are not employed in the collection of information.

TABLE 1


RECORDKEEPING BURDEN

NUMBER OF

RECORDKEEPERS

NUMBER OF

RECORDS/

RECORDKEEPERS

NUMBER

OF

RECORDS

BURDEN

HOURS/

RECORDS

ANNUAL

BURDEN

HOURS

ANNUAL

COST@

$217/HR

Reactors

104

190.6

19,822

0.50

9,911

$2,150,687

Materials

114

1.77

202

0.50

101

$21,917

Totals

218


20,024


10,012

$2,172,604

TABLE 2

ESTIMATED ANNUALIZED COST TO THE NRC FOR REVIEW OF

REPORTS AND INSPECTIONS ASSOCIATED W ITH NRC FORM 4



NUMBER OF

RESPONDENTS

STAFF HOURS

PER LICENSEE

STAFF BURDEN

HOURS

ANNUAL COST@

$217/HR

Reactors

104

1.0

104

$22,568

Materials

3,890

0.1

389

$84,413

Totals

3,994


493

$106,981


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