Final Form 4 SS 102810

2

FINAL OMB SUPPORTING STATEMENT FOR

NRC FORM 4

CUMULATIVE OCCUPATIONAL EXPOSURE HISTORY

(3150-0005)

(Clearance Revision)

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 to 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 as a record of cumulative radiation dose an up-to-date NRC Form 4, “Cumulative Occupational Dose History,” or its 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

In November 2007, NRC sent a final rule to OMB titled, “10 CFR Parts 19, 20, and 50, Occupational Dose Records, Labeling Containers, and the Total Effective Dose Equivalent.” Following OMB approval of this rule, on December 4, 2007, NRC published a Federal Register Notice regarding changes to 10 CFR Parts 19, 20 and 50 (72 FR 68043). Specific changes to 10 CFR Part 20 included a change to Section 20.2104(a) that no longer requires licensees to attempt to obtain the records of cumulative occupational radiation dose for each worker requiring monitoring under 10 CFR 20.1502. Since the revision to 10 CFR Part 20 (56 FR 23391; May 21, 1991), the cumulative lifetime dose is no longer used in 10 CFR Part 20, except for cases involving planned special exposures. This revision to Section 20.2104(a) made it unnecessary for licensees to attempt to obtain lifetime exposures for workers who are not participating in a planned special exposure program. The supporting statement for this rule stated that “The final revision will only require a licensee to maintain an NRC Form 4 for a planned special exposure.  It is estimated that 99 percent of the NRC Form 4 documents will not be needed because the NRC Form 4 will only be used to authorize a planned special exposure.”  This reduced the burden for NRC Form 4 from 10,012 hours to 43 hours and 227 responses.

In 2009, the NRC submitted a change request to transfer hours from 3150-0203 (“The NARM Rule”, a final rule that affected a number of NRC information collections). This change increased the hours for NRC Form 4 to 257 respondents and 64 hours.

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 98% of the potential responses 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 2, (November 2005), “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. NRC has in place an ongoing program to examine all information collections with the goal of eliminating all duplication and/or unnecessary information collections.

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 to 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).

7. Consultations Outside the NRC

Opportunity for public comment on the information collection requirements for this clearance package was published in the Federal Register on July 29, 2010 (75 FR 44815). No comments were received.

7. Payment or Gifts to Respondents.

Not applicable.

7. 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).

7. 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.

7. Estimate of Annual Burden

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.

Although licensees are no longer required to use the form in this manner, licensees are continuing 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) system contains information on the number of transient workers at licensee sites that are subject to Section 20.2206(a)¹. These data show that in 2008, 194 sites employed 28,780 transient workers (28,582 transient workers at the 104 reactor sites + 198 transient workers at 90 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 3,654 additional materials sites are maintaining NRC Form 4 for 8,039 transient workers. The total number of transient workers at all sites is estimated to be 36,819 (28,780 transient workers at sites with data in the REIRS system + 8,039 transient workers at sites without data in the REIRS system).

Approximately, 0.50 hours is required to complete, review, and authorize each NRC Form 4. The annual burden is 18,410 hours (36,819 workers x .5 hours). The annual cost for this requirement is $ 4,731,370 (18,410 hours x $257/hour). (See Table 1).

7. 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 $1,893 (18,410 hours x $257/hour x 0.0004).

14. 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 (1 hour/site x 104 reactor sites) of inspection time is spent reviewing such records, at an average of 1 hour for each of the 104 reactor sites. The annual cost for reactor inspections to review of NRC Form 4, or its equivalent, is $26,728 (104 hours x $257/hour).

While the number of reactor sites has been constant, at 104 sites, for the past several years, 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. At the end of 2008, there were 35 Agreement States. These 35 Agreement States have regulatory authority over approximately 18,500 materials licensees.

However, NRC is responsible for conducting inspections of NRC Form 4, or its equivalent, and supporting records maintained by 3,744 materials licensees. It is estimated that approximately 374 hours (0.1 hour/site x 3,744 materials sites) of inspection time is spent reviewing such records at an average of 0.1 hour for each of the 3,744 materials sites. The annual cost for materials inspections to review these forms is $96,118 (374 hours x $257/hour).

Annually, the total time spent reviewing NRC Form 4, or its equivalent, records is 478 hours (104 hours for reactor sites + 374 hours for materials sites). The total inspection cost, annually, is approximately $122,846 ($26,728 for reactor inspections + $96,118 for materials inspections) (See Table 2). These costs are fully recoverable through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and 171.

14. Reasons for Change in Burden

The estimated burden has increased by 18,346 hours from the previous burden of 64 hours to 18,410 hours. This increase is due to the fact that licensees have continued to voluntarily provide NRC Form 4 to their employees, despite a 2007 final rule that eliminated the requirement to provide this information unless the employee was involved in a planned special exposure.

A review of the REIRS data since both rules went into effect shows that NRC licensees are continuing to provide NRC Form 4 to their employees, despite the fact that it is no longer required (unless there is a planned special exposure). As a result, the NRC has not seen a decrease in burden as anticipated.

In fact, 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:

• 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 20,024 transient workers. A review of recent REIRS data shows that as of June 2008, licensees maintained NRC Form 4, or its equivalent, records for an average of 28,780 transient workers annually.

• In addition to licensees in the REIRS system, in the current clearance, NRC has included the transient workers employed by 3,654 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 8,019 transient workers. The addition of these 3,654 sites to the estimates has greatly increased the estimated number of respondents.

The final reason for the increase in the estimated burden is an increase in the estimated time to complete NRC Form 4, from 15 minutes to 30 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 are now primarily using the NRC Form 4 to record an employee’s cumulative exposure, the burden estimate has been changed to 30 minutes. 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.

As a result of these rules, the burden on record for NRC Form 4 is:  15 minutes per response x 257 respondents x 1 response per respondent = 64.25 hours (rounded to 64 hours).

14. Publication for Statistical Use

NRC Form 4 is not published for statistical use.

14. 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.

14. 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 ASSOCIATED WITH NRC FORM 4

NUMBER OF RECORDKEEPERS		NUMBER OF RECORDS/ RECORDKEEPERS	NUMBER OF RECORDS	BURDEN HOURS/ RECORDS	ANNUAL BURDEN HOURS	ANNUAL COST@ $257/HR
Reactors	104	274.83	28,582	0.50	14,291	$3,672,787
Materials - data from REIRS	90	2.2	198	0.50	99	$25,443
Materials - licensees not subject to 20.2206(a), no REIRS data	3,654	2.2	8,039	0.5	4,020	$1,033,140
Totals	3,848		36,819		18,410	$4,731,370

TABLE 2

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@ $257/HR
Reactors	104	1.0	104	$26,728
Materials	3,744	0.1	374	$96,118
Totals	3,848		478	$122,846

1 Data in the REIRS system is based on other approved NRC information collections, such as NRC Form 5,

3150-0006