Part 19 Final SS with tables Final_Edits_4-1-2014_ver2

FINAL SUPPORTING STATEMENT

FOR

10 CFR PART 19

"NOTICES, INSTRUCTIONS, AND REPORTS TO WORKERS: INSPECTION

AND INVESTIGATIONS"

(3150-0044)

---

EXTENSION

DESCRIPTION OF THE INFORMATION COLLECTION

Licensees are required to instruct workers on matters related to radiological working conditions. This instruction ranges from a tour of the workplace pointing out hazards to a 1-week intensive course on radiation protection involving the preparation of training material. Workers need to be educated about health risks from occupational exposure to radioactive materials or radiation, precautions or procedures to minimize exposure, worker responsibility to report promptly to the Commission any licensee conditions which may lead to or cause a violation of Commission regulations, and the individual radiation exposure reports which are available to them. The licensee is required to control radiation doses to individuals in restricted areas so that, with the exception of planned special exposures under 10 CFR 20.1206, no one receives an annual dose which exceeds the limits established by 10 CFR 20.1201. The annual limit shall be the more limiting of the total effective dose equivalent being equal to 5 rems or the sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 50 rems. The annual limit to the lens of the eye is 15 rems, and 50 rems to the skin, or to any extremity.

The individual should be informed of the radiation dose he or she receives because: (a) that information is needed by both a new employer and the individual when the employee changes jobs in the nuclear industry; (b) the individual needs to know the radiation dose received as a result of an accident or incident (if this dose is in excess of the 10 CFR Part 20 limits) so that he or she can seek counseling about future work involving radiation, medical attention, or both, as desired; and (c) since long-term exposure to radiation may be an adverse health factor, the individual needs to know whether the accumulated dose is being controlled within NRC limits. Pursuant to 10 CFR 19.16, a worker may notify the Commission about radiological working conditions he believes are in violation of the Atomic Energy Act, the regulations, or license, and the worker may request an inspection. Upon receipt of such notice, the Commission must determine whether the complaint meets certain requirements specified in 10 CFR Part 19, and either request an inspection or determine that an inspection is not warranted and so notify the complainant in writing.

This clearance package incorporates burden from the “Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License and Exemptions” Final Rule, which was approved by OMB on July 2, 2013. This rule did not amend Part 19 rule language, but increased the number of persons specifically licensed under Part 40 and thus subject to Part 19.

1. JUSTIFICATION

1. Need for and Practical Utility of the Collection of Information

10 CFR 19.12 requires NRC licensees to give reports to workers as follows: "All individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 mrem (1 mSv) shall be (1) kept informed of the storage, transfer, or use of radiation and/or radioactive material; (2) instructed in the health protection problems associated with exposure to radiation and/or radioactive material, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed; (3) instructed in, and required to observe, to the extent within the worker's control, the applicable provisions of Commission regulations and licenses for the protection of personnel from exposure to radiation and/or radioactive material; (4) instructed of their responsibility to report promptly to the licensee any condition which may lead to or cause a violation of Commission regulations and licenses or unnecessary exposure to radiation and/or radioactive material; (5) instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation and/or radioactive material; and (6) advised as to the radiation exposure reports which workers may request pursuant to § 19.13. The extent of these instructions shall be commensurate with potential radiological health protection problems present in the work place.”

10 CFR 19.13 - "Notifications and Reports to Individuals," requires NRC licensees to give written reports of exposure to radiation as described in the following subsections from that regulation. The records of exposure to radiation referenced by 10 CFR 19.13 are maintained in accordance with the requirements of 10 CFR Part 20.

10 CFR 19.13(a) - “Radiation exposure data for an individual, and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual, shall be reported to the individual as specified in this section. The information reported shall include data and results obtained pursuant to Commission regulations, orders or license conditions, as shown in records maintained by the licensee pursuant to Commission regulations. Each notification and report shall: be in writing; include appropriate identifying data such as the name of the licensee, the name of the individual, the individual's social security number; include the individual's exposure information; and contain the following statement:

This report is furnished to you under the provisions of the Nuclear Regulatory Commission regulation 10 CFR Part 19. You should preserve this report for further reference."

10 CFR 19.13(b) - "Each licensee shall make dose information available to workers as shown in records maintained by the licensee under the provisions of 10 CFR 20.2106. The licensee shall provide an annual report to each individual monitored under 10 CFR 20.1502 of the dose received in that monitoring year if: (1) The individual’s occupational dose exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or tissue; (2) The individual requests his or her annual dose report.”

10 CFR 19.13(c)(1)(i), (ii) and (2) - "At the request of a worker formerly engaged in licensed activities controlled by the licensee, each licensee shall furnish to the worker a report of the worker's exposure to radiation and/or to radioactive material: (i) as shown in records maintained by the licensee pursuant to § 20.2106 for each year the worker was required to be monitored under the provisions of § 20.1502; and (ii) for each year the worker was required to be monitored under the monitoring requirements in effect prior to January 1, 1994. (2) This report must be furnished within 30 days from the time the request is made or within 30 days after the exposure of the individual has been determined by the licensee, whichever is later. This report must cover the period of time that the worker's activities involved exposure to radiation from radioactive material licensed by the Commission and must include the dates and locations of licensed activities in which the worker participated during this period."

10 CFR 19.13(d) - "When a licensee is required pursuant to §§ 20.2202, 20.2203 or 20.2204 of this chapter to report to the Commission any exposure of an individual to radiation or radioactive material, the licensee shall also provide the individual a report on his or her exposure data included in the report to the Commission. This report must be transmitted at a time not no later than the transmittal to the Commission."

10 CFR 19.13(e) - "At the request of a worker who is terminating employment with the licensee that involved exposure to radiation or radioactive materials, during the current calendar quarter or the current year, each licensee shall provide at termination to each worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee during the current year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose must be provided together with a clear indication that this is an estimate."

10 CFR 19.16(a) - "Any worker or representative of workers who believes that a violation of the [Atomic Energy] Act, the regulations in this chapter, or license conditions exists or has occurred in license activities with regard to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the Administrator of the appropriate Commission Regional Office, or to Commission inspectors. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of workers. A copy shall be provided the licensee by the Regional Office Administrator or the inspector no later than at the time of inspection except that, upon the request of the worker giving such notice, his name and the name of individuals referred to therein shall not appear in such copy or on any record published, released or made available by the Commission, except for good cause shown."

2. Agency Use of the Information

With the exception of 10 CFR 19.12 and 19.16, Part 19 information collections are not provided to the Commission; notices, instructions, and reports required by Part 19 are provided by NRC licensees to individuals participating in licensed activities. Some information collections may require an annual report to the NRC. As stated above, notices received pursuant to 10 CFR 19.16 must be reviewed by the Commission to determine whether the complaint meets certain requirements specified in 10 CFR Part 19. The Commission will then either request an inspection or determine that an inspection is not warranted and so notify the complainant in writing.

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 new automated information technology when it would be beneficial to them. NRC issued a regulation 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 25% of the responses are filed electronically.

4. Effort to Identify Duplication and Use Similar Information

The collection of the information required is not a duplication of other information. There is no similar information available to the NRC. Licensees are required to maintain this information by the provisions of 10 CFR Part 20 and to report exposure information to workers pursuant to 10 CFR Part 19. NRC has in place an ongoing program to examine all information collections with the goal of eliminating all duplication and/or unnecessary information collections.

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

There is no feasible way of reducing the burden on small businesses while still accomplishing the objective of informing individuals of their exposure to radiation. However, the burden is small and should have no significant impact on operating costs.

6. Consequences to Federal Program or Policy Activities if the Collection is Not Conducted or is Conducted Less Frequently

If the information collection were not conducted, workers would not be aware of their total radiation dose.

7. Circumstances which Justify Variation from OMB Guidelines

This action does not vary from OMB guidelines.

8. Consultations Outside the NRC

Opportunity for public comment on the information collection requirements for this clearance package was published in the Federal Register on December 30, 2013 (78 FR 79500). One comment was received on February 28, 2014 from Ellen P. Anderson of the Nuclear Energy Institute, who responded to the four questions posed by the Federal Register Notice soliciting comment on the information collection. As Ms. Anderson’s comments were supportive of the collection and the estimates, the NRC has no formal response. Ms. Anderson’s comments were as follows:

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

RESPONSE: The information collection is reasonable and it supports informing radiation workers of dose received. Data collected and reported via the NRC Radiation Exposure Information and Reporting System (REIRS) is used by some licensees for development of actions plans to further reduce radiation exposure.

2. Is the burden estimate accurate?

RESPONSE: The burden estimate ranges from 80 to 600 hours per year per nuclear power plant, depending on the radiation worker population. This includes REIRS submittals and preparation/mailing letters to individual workers.

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

RESPONSE: We have no enhancements to propose.

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

RESPONSE: We have no additional recommendations to propose. Most nuclear power plant licensees currently use automated dose collection programs that provide for accurate and efficient storage, extraction, compilation and reporting of data with minimum burden.

9. Payment or Gift 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). However, no information normally considered confidential or proprietary is requested.

11. Justification for Sensitive Questions

Not applicable.

12. Estimated Industry Burden and Burden Hour Cost

The regulations in 10 CFR Part 19 establish requirements for notices, instructions, and reports by licensees and regulated entities to individuals participating in NRC-licensed and regulated activities. As such, the majority of the requirements under this Part represent third-party disclosure notifications, in which the licensees are providing information to workers about the dose received. In this renewal, third party disclosure notifications have been captured as such in the burden tables. Previously, third party disclosure burden was captured in the recordkeeping tables.

NRC Licensees

A total of 3,000 NRC licensees respond to the Part 19 information collections. These are licensees in states who are directly regulated by the NRC. Data on the number of NRC licensees is based on data from the agency’s License Tracking System, using the most recent data from 2011. Data from the system show the current number of materials licensees (dockets 30, 40, 70, and 72) plus the number of reactor licensees is approximately 3,000 licensees.

Data on the number of workers receiving third party notifications from these licensees was obtained from the NRC’s Radiation Exposure Information and Reporting System, 2011 data.

The burden for NRC licensees to respond to the collection is shown in Tables 1-4. The total burden for NRC licensees is 52,825.9 hours (0.5 hours reporting + 3,000 hours annual recordkeeping + 1,881 hours one-time recordkeeping + 47,944.4 hours 3^rd party disclosure) at a cost of $14,368,644.80 (52,825.9 hours x $272/hour).

Agreement State Licensees

Section 274 of the Atomic Energy Act of 1954 provides a statutory basis under which NRC relinquishes to the States portions of its regulatory authority to license and regulate byproduct materials (radioisotopes); source materials (uranium and thorium); and certain quantities of special nuclear materials. The mechanism for the transfer of NRC’s authority to a State is an agreement signed by the Governor of the State and the Chairman of the Commission, in accordance with section 274b of the Act. Licensees operating in these “Agreement States” are referred to in this supporting statement as “Agreement State Licensees.” A map of Agreement States and non-Agreement States is located on NRC’s website at http://nrc-stp.ornl.gov/rulemaking.html.

The NRC has established compatibility requirements for Agreement States to implement their own regulations in a manner consistent with NRC regulations. Annually, the Agreement States provide the NRC with an estimate of the total number of licensees within their states. The total number of Agreement State licensees is based on the annual estimate provided by the Agreement States. For this renewal, the NRC used an estimate of 18,000 Agreement State licensees, based on the most recent 2011 data.

The number of Agreement State licensees subject to each individual section within Part 19 is not known, and must be estimated. NRC uses the ratio of the total of NRC licensees (subject to Part 19) to the total number Agreement State licensees to estimate the number of Agreement State respondents for each section. The current ratio, is 1:6 (NRC licensees: Agreement State licensees), based on 3,000 total NRC licensees and 18,000 Agreement State licensees.

The burden for Agreement State licensees to respond to the collection is shown in Tables 5-8. The total burden for Agreement State licensees is 276,447.9 hours (3 hours reporting + 18,000 hours annual recordkeeping + 11,286 hours one-time recordkeeping + 247,158.9 hours third-party disclosure) at a cost of $75,193,828.80 (276,447.9 x $272/hour).

The following table is a summary of the burden:

13. Estimate of Other Additional Costs

NRC has determined that the records storage cost is roughly proportional to the recordkeeping burden cost. Based on a typical clearance, the records storage cost has been determined to be equal to 0.0004 times the recordkeeping burden cost. Therefore, the records storage cost for this clearance is $3,717 (34,167.0 hours x 0.0004 x $272/hr).

14. Estimated Annualized Cost to the Federal Government

There is no cost to the Federal government except for those that involve requests by workers for inspections. Approximately one worker requests an inspection each year pursuant to 10 CFR 19.16. Each request takes an average of 3 hours to resolve. Thus, the estimated annual cost to the Federal government is $816 (1 report/year x 3 hours/report x $272/hour). This cost is fully recovered through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and/or 171.

15. Reasons for Changes in Burden or Cost

Total

The total burden estimate increased from 31,907.80 hours to 329,273.7 hours and the respondents increased from 3,847 to 21,000 (3,000 NRC licensees + 18,000 AS licensees). The primary reason for the increase in the burden is the inclusion of burden for Agreement State licensees, which was not included in previous submissions of this collection. The NRC is seeking to correct this omission in the current submission.

Responses increased from 3,995 responses to 1,426,121.8 responses, partially due to the addition of Agreement State licensee responses. The primary reason for the increase in the number of responses is the separation of 3^rd party disclosure requirements, which were previously included in recordkeeping totals. Previously, only the number of reporting responses plus the number of recordkeepers were counted in the number of responses. Because the current submission is based on third-party disclosures, the number of responses is based on the number of disclosures the licensees must make to their workers. Because of the large number of workers, this dramatically increased the number of responses.

The current submission does not represent any changes in the requirements for licensees; rather, it represents two changes in the way that the NRC estimates the burden under this Part: the inclusion of Agreement State licensees and accounting for third-party disclosures.

The following table is a summary of the change in burden from the 2011 renewal to the current request:

NRC Licensees

The burden estimate for NRC licensees changed from 31,907.80 hours to 52,825.9 hours, an increase of 20,918.10 hours. This increase is attributed to the change in the method used to account for burden. The burden is accounted for as third-party disclosure burden rather than recordkeeping burden. Although the burden assumptions used in previous renewals were used to the extent possible, the burden for some requirements increased when the number of disclosures was taken into account.

Note that the change in burden is not due to an increase in the number of NRC licensees. The previous burden estimates were based on 3,844 licensees, whereas the current request is based on 3,000 licensees. Data on the number of NRC licensees is taken from the NRC’s License Tracking System, which shows the actual number of NRC licensees at any given time.

The estimated number of NRC licensee responses changed from 3,995 responses (124 reporting responses + 3,844 recordkeepers + 27 third-party) to 267,829 responses (1 reporting response + 3,000 recordkeepers + 264,828 third-party disclosure responses), an increase of 263,834 responses. This change is a direct result of accounting for third-party disclosures.

Agreement State Licensees

The current submission corrects an omission in the previous submissions of the Part 19 information collection. Previous submissions of Part 19 did not include estimates of Agreement State licensees’ burden and responses. As a result, all Agreement State licensee burden (276,447.9 hours and 1,158,292.8 responses) is new burden. In addition, the inclusion of Agreement state licensees in the totals adds 18,000 respondents.

Other NRC information collections for which the NRC can relinquish regulatory authority to a state have historically included estimates for Agreement State licensee burden (for example, 10 CFR Parts 32, 32, and 35). The NRC believes it is appropriate to include this burden in Part 19 because of the compatibility requirements for this Part (Agreement State licensees must fulfill the same requirements as NRC licensees). Note that this change does not expand the universe of respondents for this collection; rather, it corrects the methodology used to estimate the number of respondents for the collection.

16. Publication for Statistical Use

NRC does not publish this information for statistical use.

17. Reason for Not Displaying the Expiration Date

The requirement is contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become obsolete would be unduly burdensome and too difficult to keep current.

18. Exceptions to the Certification Statement

Not applicable.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

Not applicable.

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