DAR File No. 43812

Environmental Quality, Waste Management and Radiation Control, Radiation

Rule R313-32

Medical Use of Radioactive Material

Notice of Proposed Rule

(Amendment)

DAR File No.: 43812
Filed: 06/14/2019 01:46:28 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of these rule changes are to update the medical use of radioactive material requirements which were last updated in their entirety in 2002. The proposed changes address technological advances, changes to medical procedures, and enhance patient safety. The changes are proposed in order to maintain compatibility with U.S. Nuclear Regulatory Commission (NRC) requirements. To maintain authority to regulate certain licensed radioactive materials in the state of Utah, the state must maintain rules that are compatible with NRC requirements. Recent changes to 10 CFR Part 35 and related NRC requirements were adopted by the NRC and published in the 07/16/2018 Federal Register (83 FR 33046). These proposed rule changes maintain compatibility with the changes published for the requirements in 10 CFR Part 35 by incorporating the 2019 version of 10 CFR Part 35 by reference. An additional change is being requested to Rule R313-32 to allow licensees to hold radioactive wastes with half-lives less than 175 days to be disposed using the decay in storage method so that the materials will not be required to be disposed as low level radioactive waste.

Summary of the rule or change:

These proposed rule changes address the removal of the requirement for a written attestation statement from proposed authorized users who are board certified by approved specialty boards, adds the ability for licensees to have Associate Radiation Safety Officers, clarifies requirements for the use of sealed sources in diagnostic procedures, clarifies training and experience requirements for unsealed radioactive materials requiring the use of a written directive, includes additional requirements for testing and reporting requirements for the use of generators used for obtaining specific isotopes, includes changes to the medical event requirements, and adds specific medical event reporting requirements for permanent brachytherapy implants. In addition to the above changes to adopt the NRC revisions, a change is being proposed to add a new subsection, as stated in Subsection R313-32-2(5), to include specific requirements for holding radioactive waste for "decay-in-storage" (DIS) if the radioactive material has a half-life of greater than 120 days, but less than 175 days. Currently, radioactive waste containing materials with half-lives greater than 120 days is required to be disposed as low-level radioactive waste (LLRW). Recently, a new radioactive drug using Lutetium-177 (Lu-177) was introduced into use at medical facilities in the state of Utah. It has been determined that this drug contains a very small quantity of a radioactive impurity that has a half-life of about 161 days. If the impurity is detected in the radioactive waste, the waste created from the administration of Lu-177 is required to be disposed as LLRW unless a variance from the Board is requested and approved. In anticipation of the increased use of this radioactive drug, the proposed change will allow the Director to approve an amendment for the DIS of radioactive waste containing materials with half-lives greater than 120 days but less than 175 days on a case-by-case basis. For approval, the licensee would be required to demonstrate that the waste will be secured and safely stored, that the additional waste would not exceed the licensee's storage capacity, and that the licensee will meet the survey criteria required for DIS waste with half-lives of 120 days or less.

Statutory or constitutional authorization for this rule:

• Section 19-6-104
• Section 19-3-104

This rule or change incorporates by reference the following material:

• Updates 10 CFR Part 35, published by GPO, 01/01/2019

Anticipated cost or savings to:

the state budget:

The following are very rough estimates of the possible costs and benefits associated with the proposed changes. The implementation of these proposed requirements is dependent on the uses of radioactive materials by each separate licensee. Licensees in the state that use radioactive materials only for diagnostic purposes may not choose or be required to implement any of the proposed changes or may choose to implement just a few of the proposed changes. Licensees using radioactive materials for the therapeutic treatment of patients will be required to implement certain of the proposed changes, but may choose not to implement other proposed changes. Since each licensee is not required to implement all of the proposed rule changes, licensees may choose to avail themselves of some of the proposed requirements that benefit licensees multiple times in a year, may not implement any of the proposed changes or may implement the proposed changes in a myriad of combinations, an estimate of the costs and benefits to licensees and state agencies is difficult to determine. However, rough estimates were made for the proposed changes. For the rough estimates, it was assumed that the 45 medical use licensees could simplistically be separated into businesses that provide both diagnostic and therapeutic treatments with radioactive materials and those licensees that provide only diagnostic services using radioactive materials. It was also assumed that each group would use each of the proposed rule change s possibly applicable to their operations at least once in a year. As an example, it was assumed that businesses performing only diagnostic scans would have no need to add an Associate Radiation Safety Officer (ARSO) to their radioactive materials license since the types of radioactive materials used at these facilities would be limited. Also, since the requirements of Rule R313-32 (incorporating 10 CFR 35.490 or 10 CFR 35.690 by reference) apply only to the therapeutic use of radioactive materials, these requirements would not be applicable to those businesses that only provide diagnostic services. Lastly, for determining the costs or benefits associated with the proposed requirements, all estimates for the number of licensees affected by the proposed requirement was rounded up to the next whole number when calculating the number of impacted licensees. There are currently 45 licensees authorized to medically use radioactive materials pursuant to Rule R313-32. Therefore, the DWMRC provides regulatory oversight for 45 medical use licensees. Of these, four are operated by a state-owned and operated entity. One of these four licensees provides both diagnostic and therapeutic treatments for patients while the other three licensees limit their practices to diagnostic services. There are no fees associated with the proposed rule changes. The proposed rule changes will result in both direct fiscal costs and direct fiscal benefits in the form of personnel costs and savings to the state licensees. Using the NRC's regulatory impact analysis associated with the federal regulatory changes to 10 CFR Part 35 (ML16124B034, Secy-16-0080; Enclosure 2) as guidance and using the assumptions stated above, for the four licensees there may be an estimated direct fiscal cost for the implementation of these requirements of approximately $2,963.96. In addition, the four licensees could experience an annual direct fiscal cost of approximately $1,064.49 and a direct fiscal benefit of approximately $2,102.45. In addition to the direct fiscal costs and benefits, the state may also experience indirect fiscal cost and benefits related to the regulatory oversight of the licensees. These costs and savings are based on personnel costs and savings and are related to the processing of requests to add authorized users and other changes to the radioactive materials licenses, as well as, responses to reports made to the state due to the proposed changes. The state will incur a one-time indirect fiscal cost of about $6,480 to implement the proposed changes and an annual ongoing indirect fiscal cost of about $971.10 for the regulatory oversight of the proposed changes. In addition to the stated indirect fiscal costs, the state could also experience indirect fiscal benefits of about $3,870.00 annually. These licensees will also be impacted by the requirement proposed for the disposal of certain materials. This requirement will result in a direct benefit to the licensees; however, the benefit cannot be analyzed at this time. The radioactive material in question is from a new medical treatment for certain cancers and it is unknown how many facilities will provide this treatment to patients or how much waste will be created from its use. Therefore, this direct fiscal benefit cannot be estimated. In total, the state may experience one-time direct fiscal implementation costs of about $2,963.96 and experience ongoing direct fiscal costs of about $1,064.49. Additionally, the state may experience one-time indirect fiscal implementation costs of about $6,480 and indirect fiscal costs of about $971.10 annually. The state may also experience direct fiscal benefits of approximately $2,102.45 and indirect fiscal benefits of about $3,870 annually.

local governments:

These proposed rule changes are not expected to have any impact on the revenues or expenditures for local governments because it only affects government agencies at a state level. There are no radioactive material licenses for the medical use of radioactive materials issued to a local government entity. Additionally, local governments have no regulatory authority for the possession and use of radioactive materials.

small businesses:

There are 12 small businesses in the state of Utah that have radioactive materials licenses authorizing the medical use of radioactive materials (NAICS # 622111). Of the 12 licensees, 5 of the licensees provide only diagnostic services to their patients. The remaining 7 licensees provide treatment for various cancers and other therapeutic treatments. There are no fees associated with the proposed rule changes. The referenced information and noted assumptions stated under the state budget answer above were also used to develop the analysis for this section. As stated above, licensees may experience both one-time and ongoing (annual) direct fiscal impacts associated with the implementation of the proposed requirements. The 5 licensees limited to providing diagnostic treatments may experience one-time direct fiscal impacts of about $906.75 and ongoing direct fiscal impacts of about $525.92. Additionally, these licensees may experience annual direct fiscal benefits of approximately $1,450.80. The remaining 7 small business licensees, who provide both diagnostic and therapeutic treatments to patients, may incur direct fiscal impacts of about $7,846.12 to implement the proposed changes and annual direct fiscal impacts of about $1,904.18. Licensees providing both diagnostic and therapeutic services using radioactive materials may also experience direct fiscal benefits of about $4,532.30 annually. In total, the licensees considered to be small businesses may experience one-time direct fiscal implementation costs of about $17,846.05 and annual direct fiscal costs of about $2,430.10. The small business licensees may also experience annual direct fiscal benefits of approximately $5,983.10.

persons other than small businesses, businesses, or local governmental entities:

It is difficult to determine how many persons as defined above will be impacted by these proposed rule changes. An individual will only be affected by the proposed rule changes regarding applications to be named on a license as an authorized user or an authorized medical physicist if the individual is board certified and has not previously been named on a radioactive materials license. This information cannot be determined until the information is received. The NRC determined that there is about a 3% turnover rate for licensees, but this includes individuals leaving employment at one facility and beginning practice on a different license. Assuming that each licensee has approximately four unique physicians named on the license and there are eight medical physicists in the state, there are about 200 individuals named on the 45 medical licenses. If a 3% turnover is assumed, 6 of the individuals would leave employment. If those individuals are replaced by physicians that have never been named on a license, it is assumed that 30% of those individuals would be certified by one of the approved specialty boards. Therefore, it is possible that two individuals might benefit from the proposed changes to the requirements. This would be an indirect fiscal benefit in that the individuals will save the time necessary from collecting the written attestation statements that they were provided when completing their schooling and providing it to their new employer (the licensee) for the licensee to request that the individual be added to the license. It is estimated that this would save each individual about one half hour of time spent to locate the paperwork they were previously given. Therefore, each individual may experience a direct fiscal benefit of about $64.25 or a total of about $128.50 for both individuals. Note that this is a one-time benefit unless the individual requests to expand their radioactive material authorizations to add additional radioactive materials approvals for materials that they have not used before.

Compliance costs for affected persons:

Small business licensees providing diagnostic services may incur one-time direct fiscal cost of $181.35 and ongoing (annual) fiscal cost of about $105.18 per licensee to implement the proposed changes. These direct fiscal costs will be offset by the potential direct fiscal benefits of about $290.16 that may be experience by each of these licensees. Small business licensees providing both diagnostic and therapeutic services may experience one-time direct fiscal cost of about $2,419.90 and ongoing (annual) direct fiscal cost of approximately $272.03 per licensee. Additionally, each of these licensees may experience direct fiscal benefit of about $647.47 per license. Non-small business licensees providing diagnostic services may incur one-time direct fiscal cost of $181.35 and ongoing (annual) fiscal cost of about $217.62 per licensee to implement the proposed changes. These direct fiscal costs may be offset by the potential direct fiscal benefit of $435.24 that could be experienced by each of these licensees. Non-small business licensees providing both diagnostic and therapeutic services may experience one-time direct fiscal cost of about $2,419.90 and ongoing (annual) direct fiscal cost of approximately $285.10 per licensee. Additionally, each of these licensees could experience direct fiscal benefit of about $560.97 per license to offset the costs associated with the proposed changes. Individuals who are approved by an authorized specialty board and work for a licensee who wishes to add the individual to the licensee's radioactive materials license may save approximately one half hour of their time to locate the written attestation statement that they were provided upon completion of their training. Therefore, each individual may save about $64.25.

Comments by the department head on the fiscal impact the rule may have on businesses:

The proposed requirements are being adopted to remain compatible with the US Nuclear Regulatory Commission requirements and to include specific requirements for holding radioactive waste for "decay-in-storage" (DIS) if the radioactive material has a half-life of greater than 120 days but less than 175 days. Although rough estimates of the possible costs and benefits to these entities are provided above, the numbers may not be very accurate for each separate licensee. Many of the proposed changes may or may not be implemented by a licensee depending on the types of radioactive materials used. Additionally, many of the proposed requirements could be used many times within a year. For example, if the licensee is adding multiple authorized users for radioactive materials listed in Rule R313-32 (incorporating 10 CFR 35.100 by reference), the licensee may experience the possible direct fiscal benefit associated with the proposed changes for each board approved individual that is being added to their license. It is also possible that the licensee will not experience a benefit from the addition of any individual to the license if the individuals are not board certified or were previously named on another radioactive materials license. Licensees may implement the proposed changes in a myriad of combinations or may not implement any of the proposed changes. Because of this, there is a wide range of potential costs and benefits associated with the proposed changes for each licensee. The reported costs and benefits assume that each licensee would implement the proposed changes applicable to the two main categories of services provided at least once, unless the proposed changes were not applicable to the facilities within the state. For example, although the proposed changes add a requirement to test the breakthrough concentration for each eluate of a Mo-99/Tc-99m medical generator, there are no medical use licensees that possess one of these generators therefore, the costs associate with the testing of the generator were not addressed in the estimate. The possible direct fiscal benefits associated with the addition of the requirement regarding the disposal of certain radioactive waste were also not included in the estimate. The radioactive materials address by the requirement added by the DWMRC are new to the market and there is no data available for its use in Utah.

Alan Matheson, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Environmental Quality
Waste Management and Radiation Control, RadiationRoom Second Floor
195 N 1950 W
SALT LAKE CITY, UT 84116-4880

Direct questions regarding this rule to:

• Gwyn Galloway at the above address, by phone at 801-536-4258, by FAX at 801-533-4097, or by Internet E-mail at ggalloway@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

07/31/2019

This rule may become effective on:

08/09/2019

Authorized by:

Ty Howard, Director

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs	FY 2020	FY 2021	FY 2022
State Government	$9,443.96	$3,166.94	$3,166.94
Local Government	$0	$0	$0
Small Businesses	$20,276.22	$2,430.10	$2,430.10
Non-Small Businesses	$65,805.97	$8,515.89	$8,515.89
Other Person	$0	$0	$0
Total Fiscal Costs:	$95,526.15	$14,112.93	$14,112.93
Fiscal Benefits
State Government	$5,972.45	$5,972.45	$5,972.45
Local Government	$0	$0	$0
Small Businesses	$5,983.10	$5,983.10	$5,983.10
Non-Small Businesses	$16,819.57	$16,819.57	$16,819.57
Other Persons	$128.51	$128.51	$128.51
Total Fiscal Benefits:	$28,903.63	$28,903.63	$28,903.63
Net Fiscal Benefits:	- $66,623	$14,790.70	$14,790.70

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non - Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

There are 32 non-small business entities (NAICS #622110, NAICS # 622111) that hold radioactive materials licenses for use of radioactive materials under the provisions of Rule R313-32 and that are not owned or operated by a state agency. The implementation of these proposed requirements is dependent on the uses of radioactive materials authorized for use by each separate licensee. Those licensees that use radioactive materials only for diagnostic purposes may not implement any of the proposed changes, may implement just a few of the proposed changes or may implement all of the proposed changes that could be applicable to their operations. Licensees using radioactive materials for the therapeutic treatment of patients will be required to implement certain of the proposed changes; however, may not implement all proposed changes. Since each licensee is not required to implement all of the proposed rule changes, may avail themselves of some of the proposed requirements that benefit licensees multiple times in a year, or may choose not to implement any of the proposed changes, an estimate of the costs and benefits to licensees and state agencies is difficult to determine. However, as before, it was assumed that the 32 non-small business medical use licensees could simplistically be separated into businesses that provide therapeutic treatments with radioactive materials and those licensees that perform diagnostic scans using radioactive materials. Although it is quite unlikely, each licensee was assumed to implement all proposed changes that could apply to their operations one time each year. Therefore, the provided estimates are likely to overestimate the costs and benefits that may be experienced by the licensees. As an example, businesses performing only diagnostic scans would have no need to write, document, and implement procedures to verify the post-implant source positions within 60 days from the date that the sources were implanted since this is a therapeutic procedure. However, there are also numerous businesses that provide therapeutic services to patients that are not authorized to permanently implant the sources to which this requirement would apply.

 

Only nine of the 32 licensees qualifying as large businesses restrict their services to diagnostic services while the remaining 23 licensees provide both diagnostic and therapeutic services using radioactive materials. There are no fees associated with the proposed changes and no fees charged for amendments to the radioactive materials licenses. The costs and benefits for each group of licensees are direct fiscal impacts for the licensee and are based on estimated savings and costs due to personnel time that will be used or saved and the average wage for the personnel performing the task or duty delineated by the proposed change. Those licensees providing only diagnostic services may experience an initial one-time direct fiscal impact of about $1,632.15 and ongoing direct fiscal impacts (annual) of about $1,958.59. These licensees may also experience a direct fiscal benefit of about $3,917.16 annually.

 

The remaining 23 licensees of the 32 non-small business licensees provide both diagnostic and therapeutic services using radioactive materials. These licensees may experience an initial one-time direct fiscal impact of approximately $55,657.93 and on-going (annual) direct fiscal impact of about $6,557.30. Additionally, these licensees may experience direct fiscal benefit of about $12,902.41 annually. These licensees will also be impacted by the requirement proposed for the disposal of certain materials.

 

The impact of the requirement proposed by the DWMRC that is not contained in 10 CFR Part 35 was not included in this analysis. This requirement will result in a direct benefit to the licensees; however, the benefit cannot be analyzed at this time. The radioactive material in question is from a new medical treatment for certain cancers and it is unknown how many facilities will provide this treatment to patients or how much waste will be created from its use. Therefore, this direct fiscal benefit cannot be estimated.

 

In total, the non-small business licensees may experience one-time direct fiscal implementation costs of about $57,290.08 and annual direct fiscal costs of about $8,515.89. These licensees may also experience annual direct fiscal benefit of approximately $16,819.57.

 

The Director of the Department of Environmental Quality, Alan Matheson, has reviewed and approved this fiscal analysis.

 

 

R313. Environmental Quality, Waste Management and Radiation Control, Radiation.

R313-32. Medical Use of Radioactive Material.

R313-32-1. Purpose and Authority.

(1) The purpose of this rule is to prescribe requirements and provisions for the medical use of radioactive material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The requirements and provisions of Rule R313-32 are in addition to, and not in substitution for, other sections of Title R313.

(2) The rules set forth herein are adopted pursuant to the provisions of Subsections 19-3-104(4) and 19-3-104(7).

 

R313-32-2. Clarifications or Exceptions.

For the purposes of Rule R313-32, 10 CFR 35.2 through 35.7; 35.10(d) through 35.10(f); 35.11(a) through 35.11(b); 35.12; and 35.13(b) through [35.3067]35.3204 ([2010]2019) are incorporated by reference with the following clarifications or exceptions:

(1) The exclusion of the following:

(a) In 10 CFR 35.2, exclude definitions for "Address of Use," "Agreement State," "Area of Use," "Dentist," "Pharmacist," "Physician," "Podiatrist," and "Sealed Source";[and]

(b) In 10 CFR 35.19, exclude "or the common defense and security";

[(b)](c) In 10 CFR 35.3067, exclude ", with a copy to the Director, Office of Nuclear Material Safety and Safeguards[.]";

(d) In 10 CFR 35.3045(d), 10 CFR 3047(d), 10 CFR 35.3067, and 10 CFR 35.3204(b), exclude "By an appropriate method listed in Sec. 30.6(a) of this chapter,".

(2) The substitution of the following date references:

(a) "May 13, 2005" for "October 24, 2002"; and

(b) ["May 10, 2006" for "April 29, 2005."]"December 31, 2019" for "January 14, 2019";

(3) The substitution of the following rule references:

(a) "Rules R313-32 and R313-15" for reference to " this part and 10 CFR Part 20" in 10 CFR 35.61(a);

(b) "Rule R313-15[or] for reference to "Part 20 of this chapter" in 10 CFR 35.70(a) and 10 CFR 35.80(a)(4);

[(b)](c) "Rules R313-19 and R313-22" for reference to "Part 30 of this chapter" in 10 CFR 35.18(a)(4);

(d) "Rules R313-19 and R313-22 or equivalent Nuclear Regulatory Commission or Agreement State requirements for reference to "10 CFR Part 30 or the equivalent requirements of an Agreement State" in 10 CFR 35.49(c)[except for the reference to "Part 30 of this chapter" found in 10 CFR 35.65(d)];

[(c)](e) "10 CFR Part 30" for reference to "Part 30 of this chapter" as found in 10 CFR 35.65[(d)](a)(4);

[(d)](f) "Rules R313-15[ and], R313-19, and R313-22" for reference to "parts 20 and 30 of this chapter" as found in 10 CFR 35.63(e)(1);

[(e)](g) "Section R313-12-110" for reference to "Sec. 30.6 of this chapter" as found in 10 CFR 35.14(c).[or for reference to "Sec. 30.6(a)" or for reference to "Sec. 30.6(a) of this chapter"];

[(f)](h) "Section R313-15-101" for reference to "Sec. 20.1101 of this chapter" as found in 10 CFR 35.24(a);

[(g)](i) "Subsection R313-15-301(1)(a)" for reference to "Sec. 20.1301(a)(1) of this chapter" as found in 10 CFR 35.310(a)(2)(i) and 10 CFR 35.410(a)(4)(i);

[(h)](j) "Subsection R313-15-301(1)(c)" for reference to "Sec. 20.1301(c) of this chapter" as found in 10 CFR 35.310(a)(2)(ii) and 10 CFR 35.410(a)(4)(ii);

[(i)](k) "Section R313-15-501" for reference to "Sec. 20.1501 of this chapter" as found in 10 CFR 35.652(a);

[(j)](l) "Section R313-18-12" for reference to "Sec. 19.12 of this chapter" as found in 10 CFR 35.27(a)(1), 10 CFR 35.27(b)(1), 10 CFR 35.310, and 10 CFR 35.410;

[(k)](m) " Rules R313-19, R313-22 and Subsection R313-22-75(10) or equivalent U.S. Nuclear Regulatory Commission or Agreement State [regulations]requirements" for reference to " 10 CFR Part 30 and Sec. 32.74 of this chapter or equivalent requirements of an Agreement State[,]" as found in 10 CFR 35.[65(b)]49(a);

[(l)](n) "Subsection R313-22-75(10) or equivalent Nuclear Regulatory Commission or Agreement State requirements" [for reference to "10 CFR 32.74 of this chapter," or for reference to "Sec. 32.74 of this chapter" except for the reference to "Sec. 32.74 of this chapter" found in 10 CFR 35.65(b)]for references to "Sec. 32.74 of this chapter or equivalent Agreement State regulations" found in 10 CFR 35.65(a)(1) and 10 CFR 35.65(a)(2);

[(m)](o) "Rule R313-70" for reference to "Part 170 of this chapter";

[(n)](p) "Subsection R313-19-34(2)" for reference to "Sec. 30.34(b) of this chapter" as found in 10 CFR 35.14(b)(4);

[(o)](q) "[Rule]Section R313-22-50" for reference to "Part 33 of this chapter" in 10 CFR 35.15;

[(p)](r) "Subsection R313-22-50(2)" for reference to "Sec. 33.13 of this chapter" in 10 CFR 35.12(e);

[(q)](s) "Subsection R313-22-75(9)(b)(iv)" for reference to "Sec. 32.72(b)(4)" in 10 CFR 35.2 for the definition of Authorized Nuclear Pharmacist;

[(r)](t) "Subsection R313-22-75(9) or equivalent Nuclear Regulatory Commission or Agreement State requirements[, 10 CFR 32.72, ]" for reference to "Sec. 32.72 of this chapter or equivalent Agreement State requirements" as found in 10 CFR 35.63(b)(2)(i), 10 CFR 35.63(c)(3)(i), 10 CFR 35.100(a)(1), 10 CFR 35.200(a)(1), and 10 CFR 35.300(a)(1);[

(s) "Subsection R313-22-75(9)(b)(v)" for reference to "Sec. 32.72(b)(5)"

(t) "(c)(1) or (c)(2)" for reference to "(c)(1)" in 10 CFR 35.50(d);

(u) "35.600 or 35.1000" for reference to "35.600" in 10 CFR 35.41(b)(1);] and

[(v)](u) "Subsection R313-22-32(9)[, 10 CFR 30.32(j),]or equivalent Nuclear Regulatory Commission or Agreement State requirements" for reference to " Sec. 30.32(j) of this chapter or equivalent Agreement State requirements" as found in 10 CFR 35.63(b)(2)(iii), 10 CFR 35.63(c)(3)(ii), 10 CFR 35.100(a)(2), 10 CFR 35.200(a)(2), or 10 CFR 35.300(a)(2).

(4) The substitution of the following terms:

(a) "radioactive material" for reference to "byproduct material";

(b) ["original" for "original and one copy";]"a Director, a Nuclear Regulatory Commission, or Agreement State" for reference to "an NRC or Agreement State" in 10 CFR 35.63(b)(2)(ii), 10 CFR 35.100(c), 10 CFR 35.200(c), or 10 CFR 35.300(c);

(c) " Director is (801) 536-0200 or after hours, (801) 536-4123" for " NRC Operations Center is (301) 816-5100[951-0550]" as found in the footnote included for 10 CFR 35.3045(c);

(d) "Form DWMRC-01, 'Application for Radioactive Material License[Application]'" for reference to "NRC Form 313, 'Application for Material License'" as found in 10 CFR 35.12(b)(1), 10 CFR 35.12(c)(1)(i) and 10 CFR 35.18(a)(1);

(e) "Form DWMRC-01" for reference to "NRC Form 313" as found in 10 CFR 35.12(c)(1)(ii);

[(e)](f) "[State of Utah radioactive materials]medical use license issued by the Director" for reference to "NRC medical use license" in 10 CFR 35.6(c);

[(f)](g) "[the ]Director, the U.S. Nuclear Regulatory Commission, or an Agreement State" for reference to "[the ]Commission or Agreement State" in 10 CFR 35.2 for the definitions of Authorized Medical Physicist (2)(i), Authorized Nuclear Pharmacist (2)(iii) and Radiation Safety Officer (2)(i), in 10 CFR 35.57(b)(1) (first instance), 10 CFR 35.57(b)(2) (first instance), 10 CFR 35.433(a)(2)(i); or for reference s to "[the ]Commission or an Agreement State" in 10 CFR 35.2 for the definitions of Associate Radiation Safety Officer (2)(i) and Ophthalmic Physicist (2)(i), 10 CFR 35.11(a),in 10 CFR 35.50(a), 10 CFR 35.50(a)(2)(ii)(A), 10 CFR 35.50(c)(1), 10 CFR 35.51(a), 10 CFR 35.51(a)(2)(i), 10 CFR 35.55(a), 10 CFR 35.190(a), 10 CFR 35.290(a), 10 CFR 35.390(a), 10 CFR 35.392(a), 10 CFR 35.394(a), 10 CFR 35.396(a)(3), 10 CFR 35.433(a)(2)(i), 10 CFR 35.490(a), 10 CFR 35.590(a), 10 CFR 35.605(a), 110 CFR 35.605(b), 10 CFR 35.605(c), 10 CFR 35.655(b) and 10 CFR 35.690(a);

[(g)](h) "[an ]Director, [the]a U.S. Nuclear Regulatory Commission, or an Agreement State" for references to "[a ]Commission or Agreement State" in 10 CFR 35.2 for the definitions of Authorized Medical Physicist (2)(iii), Authorized Nuclear Pharmacist (2)(i), Authorized User (2)(i), Authorized User (2)(iii) and Ophthalmic Physicist (2)(ii), in 10 CFR 13(b)(4)(ii), 10 CFR 35.14(a)(2)(second instance), 10 CFR 35.57(a)(1)(second instance), 10 CFR 35.57(b)(1)(second instance), 10 CFR 35.57(b)(2)(second instance), 10 CFR 35.433(a)(2)(ii)(second instance); or for references to "Commission or an Agreement State" in 10 CFR 35.50(c)(2)(second instance);

[(h)](i) ["Equivalent U.S. Nuclear Regulatory Commission or Agreement State]" license issued by the Director, the Nuclear Regulatory Commission, or the Agreement State" for reference to ["equivalent Agreement State]" Commission or Agreement State license" [as found ]in 10 CFR 35. 14(a)(2)(first instance)[63(b)(2)(i), 10 CFR 35.63(c)(3), 10 CFR 35.65(a), 10 CFR 35.100(a), 10 CFR 35.200(a), and 10 CFR 35.300(a)];

[(i)](j) "Director" for reference to "NRC Operations Center" in 10 CFR 35.3045(c),[and] 10 CFR 35.3047(c) , and 10 CFR 35.3204(a);

(k) "license issued by the Director, the Nuclear Regulatory Commission or an Agreement State" for reference to "Commission or Agreement State license" in 10 CFR 35.13(b)(4)(i), 10 CFR 35.14(a)(2)(first instance), 10 CFR 35.50(b)(1)(ii) or for reference to "Commission or an Agreement State license" in 10 CFR 35.50(b)(1)(ii), 10 CFR 35.50(c)(2), and 10 CFR 35.57(a)(2);

[(j) "Utah Division of Waste Management and Radiation Control" for reference to "NRC Operations Center" in Footnote 3 to 10 CFR 35.3045;

] [(k)](l) "Director at the address specified in Section R313-12-110" for reference to "appropriate NRC Regional Office listed in Sec. 30.6 of this chapter" in 10 CFR 35.3045(d), 10 CFR 35.3047(d), 10 CFR 35.3067, and 10 CFR 35.3204(b);

[(l)](m) "[Utah Waste Management and Radiation Control ]Board" for reference to "Commission" in 10 CFR 35.18(a)(3)(second instance) and 10 CFR 35.19;

[(m)](n) "Director" for reference to "Commission" in [10 CFR 35.10(b), ]10 CFR 35.[12(d)(2)]12(d)(4), 10 CFR 35.14(a)[(first instance)], 10 CFR 35.14(b), 10 CFR 35.18(a), 10 CFR 35.18(a)(3)(first instance), 10 CFR 35.18(b), 10 CFR 35.24(a)(1), 10 CFR 35.24(c), 10 CFR 35.26(a), and 10 CFR 35.1000(b);

[(n)](o) "[the ]Director" for reference to "NRC" in [10 CFR 35.13(b)(4)(i), ]10 CFR 35.3045(g)(1), [and ]10 CFR 35.3047(f)(1) , and 10 CFR 35.3204(a)(second instance);

[(o)](p) ["the U.S. Nuclear Regulatory Commission or an Agreement State" for reference to "an Agreement State" in 10 CFR 35.49(a) and 10 CFR 35.49(c)]"Nuclear Regulatory Commission" for reference to "Commission" in 10 CFR 35.67(b)(2);

[(p)](q) ["Director, a U.S. Nuclear Regulatory Commission, or Agreement State]" Director" for reference to ["NRC or Agreement State]"NRC" in 10 CFR 35.[63(b)(2)(ii)]3045(g)(1), 10 CFR 35.[100(c)]3047(f)(1), [10 CFR 35.200(c), ]and 10 CFR 35.[300(c)]35.3204(a)(second instance); and

[(q)](r) [In 10 CFR 35.75(a) "Footnote 1", substitute "The current version of NUREG-1556, Vol. 9" for "NUREG-1556 Vol. 9,]"the Director" for reference to "NRC" in 10 CFR 35.13(b)(4)(i);

(s) "licenses issued by the Director" for reference to "NRC licenses" in 10 CFR 35.57(c);

(t) "Director, the Nuclear Regulatory Commission, or an Agreement State" for reference to "NRC" in 10 CFR 35.13(b)(5), 10 CFR 35.14(a)(2), 10 CFR 35.57(b)(3), and 10 CFR 35.57(a)(4);

(u) "(c)" for reference to "(b)" in 10 CFR 35.92.

(5) The addition of the following to 10 CFR 35.92:

(b) The Director may approve a radioactive material with a physical half-life of greater than 120 days but less than 175 days for decay-in-storage before disposal without regard to its radioactivity on a case by case basis if the licensee:

(1) Requests an amendment to the licensee's radioactive materials license for the approval;

(2) Can demonstrate that the radioactive waste will be safely stored, and accounted for during the decay-in-storage period and that the additional radioactive waste will not exceed the licensee's radioactive waste storage capacity; and

(3) Commits to monitor the waste before disposal as stated in paragraphs (a)(1) and (a)(2) of this section before the waste is disposed."

 

KEY: radioactive materials, radiopharmaceutical, brachytherapy, nuclear medicine

Date of Enactment or Last Substantive Amendment: [October 13, 2010]2019

Notice of Continuation: July 1, 2016

Authorizing, and Implemented or Interpreted Law: 19-3-104; 19-6-107