VOLUME 48, ISSUE 5

ISSUE DATE: MARCH 7, 2016

RULE ADOPTIONS


ENVIRONMENTAL PROTECTION
AIR QUALITY, ENERGY, AND SUSTAINABILITY
DIVISION OF ENERGY, SECURITY, AND SUSTAINABILITY
COMMISSION ON RADIATION PROTECTION

48 N.J.R. 409(b)

Adopted Amendments: N.J.A.C. 7:28-1.5, 6.1, 24, 58.1, 60.1, and 61.1

Adopted Repeals: N.J.A.C. 7:28-24.10 and 24.11

Adopted New Rules: N.J.A.C. 7:28-1.6, 24.4, 24.6, 24.8, 24.13, 24.14, 24.16, 24.17, and 65

Radiation Protection Programs

Proposed: October 19, 2015, at 47 N.J.R. 2589(a) (see also 47 N.J.R. 2695(a)).

Adopted: February 10, 2016, by Bob Martin, Commissioner, Department of Environmental Protection, and January 20, 2016, the Commission on Radiation Protection, Julie K. Timins, Chair.

Filed: February 11, 2016, as R.2016 d.022, with non-substantial changes not requiring additional public notice and comment (see N.J.A.C. 1:30-6.3).

Authority: N.J.S.A. 13:1B-1 et seq., 13:1D-1 et seq., 26:2D-1 et seq., and 26:2D-24 et seq.

DEP Docket Number: 09-15-09.

Effective Date:     March 7, 2016.

Operative Dates:  March 7, 2016, Adopted Amendments to N.J.A.C. 7:28-24, Adopted New Rules N.J.A.C. 7:28-24.4, 24.6, 24.8, 24.13, 24.14, and 24.17, and Adopted Repeals N.J.A.C. 7:28-24.10 and 24:11; March 19, 2016, Adopted Amendments to N.J.A.C. 7:28-1.5, 6.1, 58.1, 60.1, and 61.1, and Adopted New Rules 7:28-1.6 and 65.

Expiration Date:  May 9, 2020.

The Radiation Protection Act, N.J.S.A. 26:2D-1 et seq., and the Radiologic Technologist Act, N.J.S.A. 26:2D-24 et seq., govern the possession, handling, and use of sources of radiation within the State of New Jersey. The Radiation Protection Act established the Commission on Radiation Protection and vested in that body the power to promulgate rules and regulations as may be necessary to prohibit and prevent unnecessary radiation. The Radiation Protection Act authorizes the Department to establish and charge fees, through the promulgation of rules, for any of the services it performs under the Radiation Protection Act. Therefore, both the Commission and the Department are adopting amendments, repeals, and new rules at N.J.A.C. 7:28, Radiation Protection Programs.

Through the Radiation Protection Act, the Radiologic Technologist Act, and the Radiation Protection Programs rules, New Jersey has a comprehensive radiation protection program encompassing x-ray machines, naturally occurring or accelerator produced radioactive materials (known as NARM), radon, clean-up of radioactively contaminated sites, monitoring around nuclear power plants, emergency preparedness and response to radiological incidents including transportation accidents, and requirements for non-ionizing sources of radiation. The State also regulates facilities through participation in the Agreement State program. As an Agreement State, New Jersey has assumed responsibility for regulation of radioactive materials that are governed under the Atomic Energy Act (AEA) through an agreement with the Nuclear Regulatory Commission (NRC). (See 42 U.S.C. § 2021.) Additionally, the Department's rules contain requirements for licensure and certification of people - radiologic technologists, nuclear medicine technologists, radon testers and mitigators, and qualified medical physicists.

The within adopted amendments, repeals, and new rules create a new license category of fusion imaging CT technology for licensed nuclear medicine technologists, establish the educational and licensing requirements and the scope of practice for this new category, and establish a new fee schedule for examination and licensing. Adopted amendments and new rules incorporate 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material, by reference into the State's rules, amend the provisions incorporating 10 CFR Part 71, Packaging and Transportation of Radioactive Materials, and provide general provisions applicable to all incorporations of the Federal Regulations into the chapter by reference, and that otherwise make the State's rules consistent with the Agreement State rules. The adopted amendments and rules also contain miscellaneous corrections to cross-references, terminology, and the previous incorporations of Federal regulations by reference.

Summary of Public Comments and Agency Responses:

The Commission and the Department accepted comments on the proposal through December 28, 2015. The following individuals provided written comments during the public comment period.

1. Callie Ascione

2. Darlene Baldasarre

3. Evelyn Borny

4. Barbara Bradway

5. Michele Carty

6. Seny Choulang

7. Carol Clark

8. Jason Colloton

9. Ed Campos

10. Jacqueline Crews

11. David Crincoli

12. Jonathan Crincoli

13. Lauren DeStefano

14. Maureen Dickerson

15. Jacob Dubroff

16. Elizabeth Dull

17. Roxanne Fagan

18. Michelle Falance

19. Michael Farwell

20. Liza Felice

21. Stephanie Fiore

22. Janelle Gallagher

23. Maria Gillis

24. Alena Gonzales

25. Shane Granitski

26. Rob H

27. Kayla Hatchell

28. Pamela Henderson, US Nuclear Regulatory Commission

29. Timothy Herbert

30. Roger Jensen, Jr.

31. Randy Jones

32. Dawn Juliana

33. Jamie Kelly

34. Danielle Leshik

35. Briana Lynn

36. Laura MacAulay

37. Mandy Malone

38. Richard Mandis

39. David Mankoff, MD

40. Eleanor Mantel

41. Jocelyn Mattingly

42. Jonathan Mota

43. Ilya Nasrallah

44. Katie Neal, Nuclear Medicine Technologist Certification Board

45. Ruthann Newcomb

46. Sabrina Ortiz-Cadorna

47. Jane Oyer

48. Joan Parks

49. Erica Payne

50. Nicole Petsis

51. Michelle Powelson

52. Daniel Pryma

53. Steve Regn

54. Alexis Rodriguez

55. Ram Shastri

56. Truxell Sherry

57. Irene Sinargridis

58. Kay Sjogren

59. Aaron Scott, Society of Nuclear Medicine and Molecular Imaging - Technologist Section

60. Christina Warner

61. Jessica Williams

62. Nikole Zallie

The comments received and the Commission's and Department's responses are summarized below. The number(s) in parentheses after each comment identify the respective commenter(s) listed above.

Comments Related to Fusion Imaging CT Technology Licensing Provisions

1. COMMENT: Licensed nuclear medicine technologists who will be licensed in fusion imaging computed tomography (CT) technology are not sufficiently trained in radiologic technology to conduct the radiologic technology portion of a Positron Emission Technology/Computed Tomography (PET/CT) or Single Photon Emission Tomography/Computed Tomography (SPECT/CT) procedure. Two years of education in diagnostic radiography is needed. Nuclear medicine technologists do not receive education in cross-sectional anatomy, radiation protection, radiation biology, or CT. These individuals could put patient safety at risk. (1, 9, 11, 12, 14, 22, 25, 30, 31, 50, 60)

RESPONSE: The adopted rules establishing the license category of fusion imaging CT technologist are in response to amendments to the Radiologic Technologist Act, N.J.S.A. 26:2D-27.1, that authorize the Radiologic Technology Board of Examiners to issue additional limited licensure to an already licensed nuclear medicine technologist who has completed additional education and demonstrated competency in CT. The additional licensure provides additional privileges limited to the performance of the CT portion of a fusion imaging procedure (PET/CT or SPECT/CT). Currently, only five CT procedures are commonly performed as part of a fusion imaging procedure.

The Department and Commission have determined that the adopted requirements will ensure patient safety and competency in CT procedures performed as part of fusion imaging procedures by licensed nuclear medicine technologists who are also licensed in fusion imaging CT technology. In order to ensure patient safety, the adopted rules require nuclear medicine technologists seeking licensure to perform fusion imaging CT technology to undergo training specifically related to the non-nuclear portion of a fusion image. Moreover, the curricula of all schools of nuclear medicine technology in New Jersey include instruction in cross-sectional anatomy, radiation protection, radiation biology, and CT imaging.

A nuclear medicine technologist seeking licensing in fusion imaging CT technology can qualify to apply for the additional license in one of three ways. Under the first method, he or she may demonstrate competency by completing the required coursework, including demonstrating clinical experience and competency in performing a minimum of 125 CT procedures, and pass the American Registry of Radiologic Technologists (ARRT) CT certification examination. These are the same requirements already completed by 1,575 New Jersey diagnostic radiologic technologists who are certified by the ARRT in CT. The second method is to complete the required coursework, including demonstrating clinical experience and competency in performing a minimum of 500 hours in CT procedures, and pass the Nuclear Medicine Technologist Certification Board's (NMCTB) CT certification examination. The third method is to complete the required coursework in the five CT content areas at N.J.A.C. 7:28-24.6(a)1, competently perform a minimum of 20 fusion imaging CT procedures as required at N.J.A.C. 7:28-24.6(a)2, and pass the State examination in fusion imaging CT technology. Both ARRT and NMTCB CT certifications are recognized by the Federal government under the 2008 Medicare Improvement for Patients and Providers Act (MIPPA) as evidence of competency in performing CT procedures.

2. COMMENT: The proposed fusion imaging CT technology licensing requirements are appropriate and reasonable and will improve patient care and efficiency while decreasing costs, since only one licensed technologist will be required to perform the entire fusion imaging procedure. (2-8, 10, 13, 15-21, 23, 24, 26, 27, 32-40, 42-45, 47-49, 52-54, 56-59, 61, 62)

RESPONSE: The Department and Commission acknowledge the commenters' support for the adopted rules.

3. COMMENT: Existing technologists who hold licenses in both diagnostic radiologic technology and nuclear medicine technology should be grandfathered under the new license category, so that they may continue to perform the complete fusion imaging procedure. Those individuals who already hold both a nuclear medicine and diagnostic technology license should not be required to obtain another sub-specialty license. The sub-specialty license in fusion imaging CT technology is unnecessarily restrictive and a financial burden. (29)

RESPONSE: Individuals who hold licenses in both nuclear medicine technology and diagnostic radiologic technology have been able to perform a complete fusion imaging procedure, and will continue to be able to conduct the complete fusion imaging procedure under the new rules without additional training, examination, or licensing. Under the new rules, a fusion imaging procedure may be performed by one licensed fusion imaging CT technologist, or a person licensed in nuclear medicine technology and a person licensed in radiologic technology. Under the second option, one person with both a nuclear medicine technology license and a diagnostic radiologic technology license may perform both roles. The new license category does not reduce the pool of professionals who may perform the fusion imaging procedure, but rather expands it.

4. COMMENT: The proposed rule will flood the market, affecting jobs and salary with less experienced personnel. (25, 30)

RESPONSE: The adopted rules creating the new license category of fusion imaging CT technologist will increase the number of licensed technologists who can perform the CT portion of a fusion imaging procedure; however, the licensed fusion imaging CT technologists will not be less experienced in performing fusion imaging procedures. See the Response to Comment 1 for a discussion of the education, experience, and certifications required as prerequisites to licensure. As discussed in the Economic Impact, 47 N.J.R. at 2600, there may be an impact on salaries of licensed radiologic technologists in those facilities that no longer require a radiologic technologist to perform a PET/CT or SPECT/CT, if the facilities do not have other procedures for the radiologic technologists to perform. However, to the extent that the radiologic technologist will be available to perform more radiologic procedures, a facility may be able to increase the number of such procedures it schedules, thereby eliminating any negative impact on the salaries of the radiologic technologists. As stated in the Response to Comment 8, nuclear medicine technologists licensed in fusion imaging CT cannot perform standalone CT procedures for diagnostic purposes.

5. COMMENT: The license in fusion imaging CT technology is a good idea, but why should a nuclear medicine technologist, who has completed CT training as part of his or her education and has passed the NMTCB entry level nuclear medicine examination that included questions on CT, need to pass another examination to be licensed in fusion imaging CT technology? (41)

RESPONSE: The Radiologic Technologist Act at N.J.SA. 26:2D-31.a requires a person to pass a licensing examination in his or her specialty. The NMTCB's Components of Preparedness (www.nmtcb.org/exam/cops.php) is a detailed description of the basic tasks that are tested in the NMTCB examination. The most recent Components of Preparedness contains only limited examination content in CT, which the Department and the Commission find insufficient to ensure competency. The NMTCB also recognized that a more comprehensive examination in CT is needed and, in November 2014, started to offer an advanced skill certifying examination in CT. An individual who has passed the advanced skill certifying examination in CT is eligible to apply for licensing in fusion imaging CT technology.

6. COMMENT: The rule should allow a diagnostic radiologic technologist with proper training be licensed to perform the PET or SPECT portion of a fusion imaging procedure. (25, 46)

RESPONSE: The Radiologic Technologist Act provides that a nuclear medicine technologist with additional training may be licensed to perform the CT portion of a fusion imaging procedure. The Act does not allow a licensed diagnostic radiologic technologist to be licensed in fusion imaging CT technology, unless he or she is also a licensed nuclear medicine technologist.

There are additional reasons to allow only a nuclear medicine technologist with the additional license in fusion imaging CT technology to perform the entire fusion procedure. The American Society of Radiologic Technologists analyzed the educational curricula of schools of diagnostic radiography and nuclear medicine. That analysis revealed that a diagnostic radiologic technologist would need to undergo much more training to competently perform the nuclear medicine tasks associated with PET or SPECT imaging than a nuclear medicine technologist would need in order to competently perform the CT portion of a fusion imaging procedure. Further, there are several radiation hazards involved in the handling and administration of radioactive materials, especially positron emitters such as F-18. Handling and administering these radioactive materials are among the routine tasks of a nuclear medicine technologist. Limiting the handling of nuclear materials to the licensed nuclear medicine technologist reduces the risk of radiation contamination and lessens the risk of unnecessary radiation exposure to technologists, patients, and the public. There are fewer than 100 fusion imaging units in New Jersey, most of which are located in nuclear medicine departments of hospitals. It is not likely that a nuclear medicine department would employ a diagnostic radiologic technologist who holds the limited license that the commenter suggests, since the only nuclear medicine procedures that the person could perform would be the PET or SPECT portion of a fusion imaging procedure.

7. COMMENT: The proposed rules will allow unlicensed persons to operate x-ray equipment. (51, 55)

RESPONSE: The rules related to the new license category of fusion imaging CT technologist do not allow unlicensed people to operate x-ray equipment. In order to perform the CT portion of a fusion imaging procedure, the licensed nuclear medicine technologist must also hold a separate license in fusion imaging CT technology. The fusion imaging CT technology license does not permit a nuclear medicine technologist to perform standalone CT procedures for diagnostic purposes. CT procedures that are not part of a fusion imaging procedure must still be performed by a licensed diagnostic radiologic technologist.

Comments on Agreement State Provisions

8. COMMENT: The language in N.J.A.C. 7:28-1.5(b) requiring that "all communications regarding radioactive materials...be addressed to the New Jersey Department of Environmental Protection..." conflicts with Federal regulations that require communications be addressed to the Nuclear Regulatory Commission (NRC), such as in 10 CFR 37.27(a). Similarly, proposed N.J.A.C. 7:28-1.6(m) replaces any NRC contact information with the Department contact information in N.J.A.C. 7:28-1.5(b). In some cases, the NRC contact information must be retained, such as in 10 CFR 71.97. In contrast, proposed 10 CFR 40.22(c) and 40.55(d)(1) should contain State contact information, rather than the "Director of the Office of Nuclear Material Safety and Safeguards." (28)

RESPONSE: N.J.A.C. 7:28-1.5 is modified on adoption to correct the conflict between the State's rules and 10 CFR 37.27(a). The Federal regulation relates to the requirements for criminal history records checks of individuals granted unescorted access to category 1 or category 2 quantities of radioactive material. As proposed, the rule would direct communication regarding criminal history records checks to the Department, rather than to the NRC. One purpose of the Federal regulation is to enable the NRC to transmit fingerprints of individuals who have unescorted access to category 1 or category 2 quantities of radioactive material to the Federal Bureau of Investigation. N.J.A.C. 7:28-1.5(b) as modified on adoption requires that communications under 10 CFR 37.27 continue to be directed to the NRC, rather than to the Department. New Jersey licensees that are subject to fingerprinting must also send correspondence and checks to the NRC at the NRC addresses and/or emails specified in 10 CFR 37.27(c)(1) and (2). In order to ensure that the State's rules direct correspondence to the NRC where appropriate, adopted N.J.A.C. 7:28-1.6(m) clarifies that if the incorporation by reference replaces "Commission," "Nuclear Regulatory Commission," "NRC," and "U.S. Nuclear Regulatory Commission" with NRC, then the corresponding contact information is also replaced. Consequently, if "Commission," "Nuclear Regulatory Commission," "NRC," and "U.S. Nuclear Regulatory Commission" are not being replaced, then the contact information, if indicated, remains the NRC contact information.

N.J.A.C. 7:28-1.6(i) Table 1 is modified on adoption to add "Director of the Office of Nuclear Material Safety and Safeguards" to the list of terms in the Federal regulations incorporated into the Department's rules by reference that are replaced with the "Bureau of Environmental Radiation at the address specified in N.J.A.C. 7:28-1.5(b)." This modification on adoption will address the commenter's concern with regard to 10 CFR 40.22(c) and 40.5(d)(1), and other regulations that refer to the Director of the Office of Nuclear Material Safety and Safeguards.

9. COMMENT: Proposed N.J.A.C. 7:28-1.6(f) states that if there are inconsistencies between the State's rules and the Federal regulations incorporated by reference, the Federal regulations will prevail unless the State's rules are more stringent. This provision could result in the State's rules regarding provisions designated compatibility category A or B being more stringent than the Federal regulations, which an Agreement State's rules may not be. (28)

RESPONSE: At present, there are no State rules regarding provisions identified as compatibility categories A or B that are more stringent than the Federal regulations. Nevertheless, as an Agreement State, New Jersey may not promulgate rules regarding compatibility categories A or B that are more stringent than the Federal regulations. Accordingly, N.J.A.C. 7:28-1.6(f) is modified on adoption to ensure that the State's rules do not violate the Agreement State requirements as to compatibility categories A or B.

10. COMMENT: Proposed N.J.A.C. 7:29-1.6(h)1 refers to a specific NRC website to determine the compatibility category of a provision of the NRC regulations. If that web address is changed, the State's rules would be incomplete. The correct reference is to the Federal Register. When the NRC promulgates an Agreement State-related regulation, it provides in the Federal Register a table showing each rule provision and the assigned compliance category. Courtesy copies of the tables are provided at the web address in the proposed rules; however, the Federal Register contains the official record. (28)

RESPONSE: N.J.A.C. 7:28-1.6(h)1 is modified on adoption to refer to the Federal Register, rather than the NRC website, in order to prevent the difficulty the commenter raises.

11. COMMENT: Proposed N.J.A.C. 7:28-60.1(a) incorporates Appendix A, 10 CFR Part 70 by reference. The Appendix is compatibility category NRC, which remains within the jurisdiction of the NRC, not the Agreement States. Similarly, proposed N.J.A.C. 7:28-61.1 incorporates 10 CFR 71.85(c) by reference. This provision is also identified as compatibility category NRC, and should not be incorporated into the State's rules. (28)

RESPONSE: As stated in the summary of proposed N.J.A.C. 7:28-1.6, if the NRC regulations identify an item as compatibility category NRC, then the section remains within the jurisdiction of the NRC, and it is not incorporated into N.J.A.C. 7:28 (47 N.J.R. at 2594). N.J.A.C. 7:28-60.1(b)38 is added and N.J.A.C. 7:28-61.1(b)1iii is deleted on adoption to exclude Appendix A of 10 CFR Part 70, and 10 CFR Part 71.85, respectively, as not incorporated by reference.

12. COMMENT: By operation of N.J.A.C. 7:28-1.6(i), the State's rules mistakenly substitute the term "Department" for "NRC" in 10 CFR 71.17, incorporated by reference at N.J.A.C. 7:28-61.1(c)1. Also, at 10 CFR 71.106, incorporated by reference at N.J.A.C. 7:27-61.1, "NRC" should be replaced with "Department." (28)

RESPONSE: As modified on adoption, N.J.A.C. 7:28-61.1(c)1iii identifies 10 CFR 71.17 as a regulation for which "Commission," "Nuclear Regulatory Commission," "NRC," and "U.S. Nuclear Regulatory Commission" are not replaced with "Department." Proposed N.J.A.C. 7:28-61.1(c)1ix would have resulted in the term "Nuclear Regulatory Commission" remaining in the Federal regulation as incorporated by reference. As the commenter states, in this instance the term in the Federal regulation should be replaced with "Department"; accordingly, the rule is modified on adoption to delete N.J.A.C. 7:28-61.1(c)1ix. By operation of N.J.A.C. 7:28-1.6(i), under the adopted rule, "NRC" is replaced with "Department" at 10 CFR 71.106.

13. COMMENT: In the word and term replacements in N.J.A.C. 7:28-1.6(i) Table 1, change the definition of Agreement State in 10 CFR 37.5 so that it does not meet the compatibility category B designation assigned to it. New Jersey should include the definition of Agreement State at 10 CFR 37.5 in the list of regulations in N.J.A.C. 7:28-65.1(c)1 and 3 for which substitutions are not made. (28)

RESPONSE: Adopted N.J.A.C. 7:28-65.1 incorporates by reference the Federal regulations at 10 CFR Part 37. As proposed, the operation of adopted N.J.A.C. 7:28-1.6(i) would replace the terms "Commission," "Nuclear Regulatory Commission," "NRC," and "U.S. Nuclear Regulatory Commission" with "Department," and "Act" with "Radiation Protection Act." The Federal regulation at 10 CFR 37.5 defines "Agreement State" as "any state with which the Atomic Energy Commission or the U.S. Nuclear Regulatory Commission has entered into an effective agreement under subsection 274b of the Act." Replacing "U.S. Nuclear Regulatory Commission" with "Department" and "Act" (meaning the Atomic Energy Act) with "Radiation Protection Act" in the definition would not make sense. Moreover, the definition is one that the NRC has identified as compatibility category B, meaning that with regard to that item the rules of an Agreement State (such as New Jersey) should be essentially identical to those of the NRC. Therefore, N.J.A.C. 7:28-65.1(c)1 and 3 are modified on adoption to indicate the definition of "Agreement State" as an exception to the replacements otherwise applicable under N.J.A.C. 7:28-1.6(i).

14. COMMENT: The Federal regulation at 10 CFR 37.43(d)(1) no longer contains a reference to 10 CFR 37.43(d)(9); therefore, N.J.A.C. 7:28-65.1(c)7, which deletes the phrase "Except as provided in paragraph (d)(9) from the Federal rule incorporated by reference," is unnecessary. (28)

RESPONSE: On adoption, N.J.A.C. 7:28-65.1(c)7 is deleted and the remaining paragraphs are recodified.

15. COMMENT: The definition of "special form radioactive material" at 10 CFR 71.4 refers to past versions of 10 CFR Part 71. These references to 10 CFR Part 71 should not be replaced with N.J.A.C. 7:28-61, as they would be by operation of N.J.A.C. 7:28-1.6(i) Table 1. (28)

RESPONSE: As proposed, N.J.A.C. 7:28-61.1 incorporates by reference 10 CFR Part 71. "Special form radioactive material" is defined at 10 CFR 71.4 as a radioactive material that satisfies three identified conditions. The third condition is that the material "satisfies the requirements of § 71.75. A special form encapsulation designed in accordance with the requirements of § 71.4 in effect on June 30, 1983 (see 10 CFR part 71, revised as of January 1, 1983), and constructed before July 1, 1985; a special form encapsulation designed in accordance with the requirements of § 71.4 in effect on March 31, 1996 (see 10 CFR part 71, revised as of January 1, 1996), and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of § 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition."

By operation of N.J.A.C. 7:27-1.6(i), references in the incorporated Federal regulation to "Part 71" would be replaced with "N.J.A.C. 7:28-61." As the commenter indicates, the substitution would render the third condition in the definition of "special form radioactive material" meaningless. On adoption, N.J.A.C. 7:28-61.1(c) is modified to add paragraph 5, which states that references to past versions of 10 CFR Part 71 in the definition of "special form radioactive material" are not replaced by "N.J.A.C. 7:28-61."

16. COMMENT: In N.J.A.C. 7:28-65.1(c)1ix, New Jersey incorporates 10 CFR 37.77 by reference while maintaining that all references to the "NRC" in 10 CFR 37.77 mean the "U.S. Nuclear Regulatory Commission." However, the notifications required in the introductory paragraph to 10 CFR 37.77 and in 10 CFR 37.77(a)(1), (a)(3), (c)(1), (c)(2), and (d) should be provided to New Jersey, not the NRC. (28)

RESPONSE: As proposed, N.J.A.C. 7:28-65.1(c)1ix would result in references to "NRC" and "U.S. Nuclear Regulatory Commission" in 10 CFR 37.77 remaining as "NRC" and "U.S. Nuclear Regulatory Commission," rather than being replaced with "Department," meaning that the NRC would continue to receive advance notification of shipments of category 1 quantities of radioactive material. New Jersey relied upon the guidance document from the NRC (NUREG 2155 Rev. 1 Interpretation Guidance of Part 37) to interpret 10 CFR 37.77. The guidance document stated that both the NRC and the Agreement State should be provided advanced notification of shipment of category 1 quantities of radioactive materials. The NRC clarified in its comment on the proposal that the NRC need not be notified.

As the commenter indicates, proposed N.J.A.C. 7:28-65.1(c)1ix is incorrect. However, deleting N.J.A.C. 7:28-65.1(c)1ix and relying on the replacements required under N.J.A.C. 7:28-1.6(i) is also incorrect. Not all references in the Federal regulation to "NRC" and "U.S. Nuclear Regulatory Commission" should be replaced with "Department." 10 CFR 37.77(a)(1) uses the terms "NRC" and "U.S. Nuclear Regulatory Commission" in the context of identifying where a licensee may obtain contact information for "the office of each appropriate governor or governor's designee" for purposes of providing advance notice of the shipment of licensed material in a category 1 quantity through or across the boundary of a state. As modified on adoption, N.J.A.C. 7:28-65.1(c)1ix does not replace "NRC" or "U.S. Nuclear Regulatory Commission" with "Department" for purposes of obtaining governors' office contact information. In all other provisions of 10 CFR 37.77, N.J.A.C. 7:28-1.6(i) will result in appropriate replacements.

Federal Standards Statement

Executive Order No. 27 (1994) and N.J.S.A. 52:14B-1 et seq. require State agencies that adopt, readopt, or amend State regulations that exceed any Federal standards or requirements to include in the rulemaking document a Federal standards analysis. Adopted amendments to N.J.A.C. 7:28-24 include the educational and licensing requirements and scope of practice for the new license category in fusion imaging CT technology, which was created pursuant to State law at N.J.S.A. 26:2D-24 et seq. The Federal regulations contain no comparable licensure requirement. Although the United States Department of Health and Human Services regulations at 45 CFR Part 75 require individuals who operate ionizing radiation-producing equipment or perform nuclear medicine procedures at Federally owned or operated facilities to meet certain educational requirements, neither the adopted amendments and new rules nor any of the Department's rules governing ionizing radiation-producing equipment apply to Federal facilities.

Adopted amendments to N.J.A.C. 7:28-61, Packaging and Transportation of Radioactive Materials, are promulgated in order to comply with the Federal requirements for Agreement States. Therefore, they are consistent with and do not exceed Federal standards.

Adopted new N.J.A.C. 7:28-65, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material, is promulgated in order to comply with the Federal requirements for Agreement States. The Federal regulations are incorporated into the Department's rules by reference, and are therefore consistent with and do not exceed Federal standards.

Full text of the adopted amendments and new rules follows (additions to proposal indicated in boldface with asterisks *thus*; deletions from proposal indicated in brackets with asterisks *[thus]*):

SUBCHAPTER 1.    GENERAL PROVISIONS

7:28-1.5   Communications

(a) (No change.)

(b) *[All communications]* *Communications* regarding radioactive materials including byproduct, source, special nuclear materials less than a critical mass, or diffuse naturally occurring radioactive materials *except those communications related to 10 CFR 37.27, Requirements for criminal history records checks of individuals granted unescorted access to category 1 or category 2 quantities of radioactive material,* shall be addressed to the New Jersey Department of Environmental Protection, Bureau of Environmental Radiation, Mail Code 25-01, PO Box 420, Trenton, NJ 08625-0420. Telephone: (609) 984-5400, Fax: (609) 984-5595. The physical location of the office is 25 Arctic Parkway, Ewing, NJ 08638.

(c) All emergency notification of incidents involving sources of radiation in this State shall be immediately reported to either one of the following agencies:

1. Radiation Protection Element

   New Jersey Department of Environmental Protection
   25 Arctic Parkway
   Ewing, NJ 08638
   Telephone: (609) 984-5462
   Hours: 8:00 A.M. to 5:00 P.M. daily, except Saturday, Sunday, and Holidays
   After hours and weekends toll free: 1 (877) 927-6337 (1-877 WARN DEP)

2. (No change.)

7:28-1.6   Incorporation of the Code of Federal Regulations by reference

(a) Portions of this chapter that are incorporated by reference from any portion of the Code of Federal Regulations (CFR) shall be understood in the manner set forth in this section.

(b) Unless specifically excluded by these rules, when a provision of the CFR is incorporated by reference, all notes, appendices, diagrams, tables, and figures are also incorporated by reference.

(c) Supplements, amendments, or other changes including, without limitation, repeals or stays that affect the meaning or operational status of a Federal regulation incorporated by reference, brought about by either judicial or administrative action and adopted or otherwise noticed by the Nuclear Regulatory Commission (NRC) in the Federal Register, shall be paralleled by a similar automatic update to the New Jersey rule so that the New Jersey rule will have the same meaning and status as its Federal counterpart.

(d) Provisions of the CFR that are excluded from incorporation by reference in these rules are excluded in their entirety, unless otherwise specified. If there is a cross-reference to a Federal citation that is specifically entirely excluded from incorporation, the cross-referenced citation is not incorporated by virtue of the cross-reference.

(e) Federal statutes and regulations that are cited in the CFR that are not specifically adopted by reference shall be used to assist in interpreting the Federal regulations.

(f) In the event that there are inconsistencies or duplications in the requirements of the provisions incorporated by reference from the CFR and the rules set forth in this chapter, the provisions incorporated by reference from the CFR shall prevail, except where the rules set forth in this chapter are more stringent. *The foregoing notwithstanding, as to subparts the NRC identifies as compatibility categories A or B, in the event of inconsistencies or duplications, the provisions of the CFR shall prevail.*

(g) Nothing in these provisions incorporated by reference from the CFR shall affect the Department's authority to enforce statutes, rules, permits, licenses, or orders administered or issued by the Commissioner.

(h) The following provisions of the CFR are not incorporated by reference:

1. *[Each subpart that is designated as "NRC" in the compatibility category column of the "Regulation Toolbox: Review Summary Sheets for Regulation Adoption for New Agreement States/Programs (10 CFR_)," http://nrc-stp.ornl.gov/regsumsheets_newregs.html]* *Each subpart that the NRC identifies as compatibility category "NRC."  The compatibility category of a subpart is published in the Federal Register when the regulation is promulgated*;

2. Each section entitled "violations";

3. Each section entitled "communications"; and

4. Each section that includes "information collection requirements" in the heading.

(i) The following words and terms in the CFR shall be replaced as indicated in Table 1 below, except as otherwise indicated in this chapter:

Table 1: Replacement terms for terms in CFR provisions incorporated by reference

Terms in CFR	Replacement Terms
Of this part	Of this subchapter
To this part	To this subchapter
By this subpart	By this subchapter
Subject to this subpart	Subject to this subchapter
Under this subpart	Under this subchapter
In this subpart	In this subchapter
Agreement State or Agreement State	Agreement State or the NRC
agency
Any non-Agreement State	The State of New Jersey, where the
	Department maintains jurisdiction
Commission	Department
NRC
Nuclear Regulatory Commission
U.S. NRC
Act	Radiation Protection Act
Atomic Energy Act
Atomic Energy Act of 1954
Section __ of the Act	the Act
Part 19	N.J.A.C. 7:28-50
Part 20	N.J.A.C. 7:28-6
Part 30	N.J.A.C. 7:28-51
Part 37	N.J.A.C. 7:28-65
Part 40	N.J.A.C. 7:28-58
Part 70	N.J.A.C. 7:28-60
Part 71	N.J.A.C. 7:28-61
Part 150	N.J.A.C. 7:28-62
NRC Operations Center (301-816-5100)	Department of Environmental
	Protection's hotline 1-877 WARNDEP
	(1-877-927-6337)
Written interpretation by the General	Written interpretation signed and
Counsel	approved by the Commissioner of the
	Department
NRC regional office or Director of	Bureau of Environmental Radiation at
the office of Federal and State	the address specified in N.J.A.C.
Materials and Environmental	7:28-1.5(b)
Management Programs *[or]**;*
Director, Division of Security
Policy, Office of Nuclear Security
and Incident Response*; or
Director of the Office of Nuclear
Material Safety and Safeguards*
10 CFR 20.1401	N.J.A.C. 7:28-12
10 CFR 20.1402
10 CFR 20.1403
10 CFR 20.1404
10 CFR 20.1405

(j) Replace each section entitled "criminal penalties" with the sentence, "The Radiation Protection Act of 1958, N.J.S.A. 26:2D-1 et seq., provides for criminal sanctions for violation of any provision of the Act."

(k) In each section entitled "specific exemptions," replace the sentence "The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security, and are otherwise in the public interest" with "The Department, with approval of the Commission on Radiation Protection, may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this subchapter as it determines are authorized in accordance with the provisions of N.J.A.C. 7:28-2.8."

(l) In each section entitled "interpretations," replace "Except as specifically authorized by the Commission in writing, no" with "No."

(m) *[Replace]* *If the incorporation by reference replaces "Commission," "NRC," "Nuclear Regulatory Commission," or "U.S. NRC" with "Department," replace* any NRC contact information with the contact information in N.J.A.C. 7:28-1.5(b).

(n) Unless otherwise specified, all written reports required by a provision of the CFR incorporated by reference shall be sent to the Manager, Bureau of Environmental Radiation at the address specified in N.J.A.C. 7:28-1.5(b).

SUBCHAPTER 6.    STANDARDS FOR PROTECTION AGAINST RADIATION

7:28-6.1   Incorporation by reference

(a) Except as set forth in (b), (c), and (d) below, this subchapter incorporates by reference 10 CFR Part 20, Standards for Protection Against Radiation.

(b)-(e) (No change.)

SUBCHAPTER 24.     NUCLEAR MEDICINE AND FUSION IMAGING COMPUTED TOMOGRAPHY (CT) TECHNOLOGY

7:28-24.1   Purpose, scope, and applicability

(a) This subchapter establishes educational and licensure requirements, as well as delineating the scopes of practice, for persons engaged in the practice of nuclear medicine technology, and for persons engaged in the practice of fusion imaging CT technology. This subchapter further establishes certain responsibilities of authorized users, owners, and registrants of radiation sources used in the practice of nuclear medicine technology or the practice of fusion imaging CT technology. This subchapter also establishes standards for the operation of, and the Department's approval of, educational programs in nuclear medicine technology.

(b) This subchapter shall not be interpreted as precluding persons specializing in nuclear medicine physics, computer science, or engineering from manipulating nuclear medicine data under the supervision of an authorized user pursuant to N.J.A.C. 7:28-55.1.

(c) The following are exempt from the requirement to possess a nuclear medicine technology license:

1. Authorized users;

2. Licensed physicians who are acting under the supervision of an authorized user pursuant to N.J.A.C. 7:28-55.1;

3. Students enrolled in and attending a school of medicine or osteopathy, who are acting within the school's curriculum and under the supervision of an authorized user pursuant to N.J.A.C. 7:28-55.1; and

4. Students enrolled in and attending a Department approved school of nuclear medicine technology, who are acting within the school's curriculum, provided that students are supervised in accordance with N.J.A.C. 7:28-24.13(b)1.

(d) The following are exempt from the requirement to possess a fusion imaging CT technology license:

1. Licensed physicians;

2. Licensed diagnostic radiologic technologists;

3. Students enrolled in and attending a school of medicine or osteopathy, who are acting within the school's curriculum, and are under the direct supervision of a licensed physician or licensed diagnostic radiologic technologist or licensed fusion imaging CT technologist;

4. Students enrolled in and attending a Department approved school of nuclear medicine technology and are acting within the school's curriculum, provided that students are supervised in accordance with N.J.A.C. 7:28-24.13(b)2;

5. Licensed nuclear medicine technologists in accordance with N.J.A.C. 7:28-24.4(e); and

6. Students enrolled in and attending a Board approved school of diagnostic radiologic technology in accordance with N.J.A.C. 7:28-19.1(c)4.

(e) The requirements of this subchapter shall not apply to a licensed radiopharmacy operating within the scope of its Department radioactive materials license and New Jersey Board of Pharmacy license.

(f) Authorized users and owners of nuclear medicine technology equipment must also comply with all other applicable Federal and State radioactive material regulations.

7:28-24.2   Definitions

(a) The following words and terms, when used in this subchapter, shall have the following meanings unless the context clearly indicates otherwise.

"Authorized user" means a licensed physician who is identified as an authorized user on a Department radioactive materials license pursuant to N.J.A.C. 7:28-55.1.

"Board" means the Radiologic Technology Board of Examiners created pursuant to N.J.S.A. 26:2D-24 et seq.

"Clinical education center" means a facility (such as a medical office, hospital, or imaging center) where a person is permitted to engage in the practice of nuclear medicine technology or fusion imaging CT technology for the purposes of clinical education in these disciplines.

. . .

"Direct supervision" means being present in the room with the person to observe and supervise the nuclear medicine or CT procedure.

"Engage" means to perform or assist in the performance of an activity.

"Fusion imaging CT technology" means the use of CT equipment as part of a fusion imaging procedure.

"Fusion imaging procedure" means a medical imaging procedure that utilizes equipment capable of performing two or more types of medical imaging procedures simultaneously or in close sequence and merging the data to form a single composite image. For the purpose of this subchapter, fusion imaging procedures are limited to Positron Emission Tomography/Computed Tomography (PET/CT) and Single-Photon Emission Computed Tomography/Computed Tomography (SPECT/CT).

"Indirect supervision" means being immediately available in the room or adjacent to the room where the person is performing the nuclear medicine procedure.

"Initial application" means the first application submitted by an individual to the Department for a license to practice nuclear medicine technology or fusion imaging CT technology.

"JRCNMT" means the Joint Review Committee on Educational Programs in Nuclear Medicine Technology.

"Licensed diagnostic radiologic technologist" means a person who possesses a valid license in diagnostic radiologic technology issued pursuant to N.J.A.C. 7:28-19.

"Licensed fusion imaging CT technologist" means a licensed nuclear medicine technologist that holds an additional license issued by the Board that permits him or her to engage in the practice of fusion imaging CT technology.

. . .

"Operating CT equipment" means using or manipulating CT equipment in any way that leads to or causes the application of radiation to humans or affects the amount or quality of radiation that is received by a human. The term "operating" includes activating or terminating the radiation exposure, setting or adjusting technical factors, and setting or adjusting the size of the exposure field.

. . .

(b) (No change.)

7:28-24.3   General provisions

(a) No owner, authorized user, person, or business shall cause, allow, or permit any other person to prepare or administer radiopharmaceuticals or to otherwise engage in the practice of nuclear medicine technology or to act as a licensed nuclear medicine technologist unless that other person is an authorized user or possesses a current, validly obtained license as a nuclear medicine technologist, pursuant to this subchapter.

(b) No owner, authorized user, person, or business shall cause, allow, or permit any other person to engage in the practice of fusion imaging CT technology or to act as a licensed fusion imaging CT technologist unless that other person is a licensed physician, licensed diagnostic radiologic technologist, or possesses both a current nuclear medicine technology and a fusion imaging CT technology license pursuant to this subchapter.

(c) No person other than a licensed fusion imaging CT technologist may use the title "licensed fusion imaging CT technologist" or LRT(FCT) after his or her name.

(d) No person shall prepare or administer radiopharmaceuticals or otherwise engage in the practice of nuclear medicine technology or act as a licensed nuclear medicine technologist unless such person is an authorized user or possesses a current, validly obtained license as a nuclear medicine technologist, pursuant to this subchapter.

(e) No person shall engage in the practice of fusion imaging CT technology unless such person is a licensed fusion imaging CT technologist, or is exempt from the licensing requirements in accordance with N.J.A.C. 7:28-24.1(d).

(f) No owner, authorized user, person, or business shall cause, allow, or permit a licensed fusion imaging CT technologist to perform a CT procedure unless it is part of a fusion imaging procedure, or the technologist is authorized to perform the CT procedure in accordance with an appropriate license.

(g) No licensed fusion imaging CT technologist shall perform a CT procedure unless it is part of a fusion imaging procedure, or the technologist is authorized to perform the CT procedure in accordance with an appropriate license.

(h) No person shall use sealed sources composed of radionuclides for purposes of external beam therapy, except for an authorized user or a radiologic technologist as licensed pursuant to N.J.S.A. 26:2D-24 et seq. and N.J.A.C. 7:28-19.

(i) The owner and the holder of a Federal or State radioactive materials license shall be jointly and severally responsible for identifying and documenting the identity of an authorized user for each administration of that radiopharmaceutical. Such authorized user shall be responsible for any administration of such radiopharmaceutical by a licensed nuclear medicine technologist.

(j) The authorized user, the owner, the holder of a Federal or State radioactive materials license, and the licensed nuclear medicine technologist shall be jointly and severally responsible for complying with all license conditions including, but not limited to, recording such information as may be required as a condition of license issued pursuant to this chapter.

(k) A licensed nuclear medicine technologist shall carry out the practice of nuclear medicine technology in a manner consistent with this chapter.

(l) A licensed fusion imaging CT technologist shall carry out the practice of fusion imaging CT technology in a manner consistent with this chapter.

(m) No school of nuclear medicine technology subject to this subchapter shall enroll students unless the school is approved by the Department.

(n) No school subject to this subchapter shall hold itself out to be an approved school of nuclear medicine technology or claim in any way that completion of the school's curriculum will enable students to be eligible for New Jersey examination and/or New Jersey licensure, unless the school is approved by the Department.

(o) No person shall use or permit the use of ionizing radiation-producing equipment or radioactive materials in such a manner as to expose humans to unnecessary ionizing radiation.

(p) No person shall:

1. Engage in the use or employment of dishonesty, fraud, deception, misrepresentation, false promise, or false pretense while engaged in activities relating to nuclear medicine technology or fusion imaging CT technology or in obtaining a license in those categories;

2.-5. (No change.)

6. Engage in the practice of nuclear medicine technology or fusion imaging CT technology while in an intoxicated state or under the influence of narcotics or any drugs which impair or tend to impair consciousness, judgment, or behavior;

7. Engage in negligence, malpractice, or incompetence while practicing nuclear medicine technology or fusion imaging CT technology;

8. Falsify any records, or destroy or steal property or records, relating to the practice of nuclear medicine technology or fusion imaging CT technology;

9. Fail to exercise due regard for safety, life, or health while engaged in the practice of nuclear medicine technology or fusion imaging CT technology;

10. Violate any condition of a radioactive materials license issued by the Department pursuant to this chapter;

11. Violate any condition and restriction that the Department has placed on his or her nuclear medicine technology license or fusion imaging CT technology license; or

12. Fail to display immediately his or her nuclear medicine technology license or fusion imaging CT technology license, or a true copy thereof, upon request of the Department, employer, or any patient.

7:28-24.4      Scopes of practice

(a) Any person who possesses a valid license pursuant to this subchapter shall exercise proper principles of radiation protection with regard to nuclear medicine and CT procedures.

(b) Any person who possesses a valid license to practice nuclear medicine technology issued in accordance with this subchapter may engage in the following activities, which constitute the scope of practice of nuclear medicine technology:

1. Prepare radiopharmaceuticals for administration to humans, administering radiopharmaceuticals to humans;

2. Position patients for examinations that require the administration of radiopharmaceuticals to humans;

3. Set technical factors for examinations that require the administration of radiopharmaceuticals to humans;

4. Operate imaging and/or measuring equipment for examinations that require the administration of radiopharmaceuticals to humans;

5. Acquire and manipulate patient data with or without the use of computers for procedures requiring the administration of radiopharmaceuticals; and

6. Administer pharmaceuticals, provided that the material and its administration comply with the New Jersey State Board of Medical Examiners rule N.J.A.C. 13:35-6.20.

(c) It is not within the scope of practice of a licensed nuclear medicine technologist to:

1. Prescribe or determine the dosage of any form of radionuclide to a human being; or

2. Apply, administer, determine the dosage of, or order the administration of therapeutic doses of any form of radionuclide to a human being.

(d) Any person who possesses a valid license to practice fusion imaging CT technology issued in accordance with this subchapter may engage in the following activities, which constitute the scope of practice of fusing imaging CT technology:

1. Operate CT equipment as part of fusion imaging procedures;

2. Position patients as part of fusion imaging procedures;

3. Set technique factors and make x-ray exposures as part of fusion imaging procedures;

4. Acquire and manipulate the resultant patient imaging data obtained from a fusion imaging procedure; and

5. Perform attenuation correction.

(e) The Board may authorize a licensed nuclear medicine technologist to perform CT procedures for the purpose of gaining competency in CT for New Jersey licensure in Fusion Imaging CT Technology or national certification, provided:

1. The licensed nuclear medicine technologist submits and the Board approves an educational plan, which shall include a list of clinical prerequisites to be completed, the name and address of the clinical education center, a list of the CT equipment to be used, the names and professional credentials of the individuals who will supervise the licensed nuclear medicine technologist while he or she performs CT procedures in accordance with (e)3 below, and a schedule indicating the beginning and ending dates of the period during which the licensed nuclear medicine technologist will perform CT procedures under the educational plan. The plan shall be signed by both the licensed nuclear medicine technologist and the manager or administrator of the clinical education center;

2. The licensed nuclear medicine technologist has fulfilled the requirements at N.J.A.C. 7:28-24.6(a)1;

3. The licensed nuclear medicine technologist performs CT procedures only while under the direct supervision of a licensed physician, licensed diagnostic radiologic technologist, or a licensed fusion imaging CT technologist named in the approved educational plan identified in (e)1 above; and

4. The licensed nuclear medical technologist and clinical education center comply with the terms of the approved educational plan identified in (e)1 above.

7:28-24.5   Examination for licensure of nuclear medicine technologists

(a) Subject to (b) below, the Department shall admit to examination for licensure any applicant who has paid a fee to the Department as specified in N.J.A.C. 7:28-24.11(a) and submitted satisfactory evidence, verified by oath or affirmation, that the applicant:

1.-3. (No change.)

(b) The Department may deny an examination application if the applicant has committed any act or omission specified at N.J.A.C. 7:28-24.12(a).

(c)-(d) (No change.)

7:28-24.6   Examination for licensure of fusion imaging CT technologists

(a) Subject to the conditions in this section, the Board shall admit to examination for licensure any applicant who is of good moral character, has paid a fee to the Department as specified in N.J.A.C. 7:28-24.11(b), is licensed in nuclear medicine technology pursuant to this subchapter, and has submitted satisfactory evidence, verified by oath or affirmation, that the applicant:

1. Has successfully completed didactic content through educational activities, either in person or on line, that are recognized by the Board, in the following areas:

i. Cross sectional anatomy;

ii. X-ray physics, which shall include the production of x-rays, and operator radiation protection and shielding;

iii. Administration of oral and parenteral contrast media and treatment of adverse reactions;

iv. CT scanner design and operation, which shall include the selection of technical factors for both the scout image and patient scan protocols, verification of correct patient positioning on the scout image, setting the start and end scan location, image processing, equipment maintenance, and identification of equipment malfunctions; and

v. Patient safety, which shall include the expected delivered dose for specified procedures, and the technical factors affecting patient dose; and

2. Has competently performed a minimum of 20 fusion imaging CT procedures, including at least two different types of fusion imaging procedures, such as total body, cardiac, or brain.

(b) The Board may deny an examination application if the applicant has committed any act or omission specified at N.J.A.C. 7:28-24.12(b).

(c) An applicant who fails the examination may reapply in accordance with this section.

(d) Any person who has failed the examination three times shall not be permitted to take the examination a fourth time until the person has submitted proof of completion of a remedial course that includes a full review of course material in areas of low performance as identified by the examination.

(e) After the fourth failure, the person may not retake the examination until that person has submitted proof that he or she has recompleted the requirements of (a)1 and 2 above.

(f) Examinations shall be offered at the discretion of the Board.

7:28-24.7   Nuclear medicine technologist licenses

(a) The Department may issue a license to any applicant who is at least 18 years of age and has paid a fee to the Department as specified in N.J.A.C. 7:28-24.11(a) and who has submitted satisfactory evidence, verified by oath or affirmation, that the applicant:

1. Has within three years of the date of application passed a nuclear medicine technology examination administered by the American Registry of Radiologic Technologists, Nuclear Medicine Technology Certification Board or American Society of Clinical Pathologists, or another examination approved by the Commission;

2. Holds a current certificate, registration, or license as a nuclear medicine technologist issued by another state or country or by any of the organizations named in (a)1 above and has engaged in the practice of nuclear medicine technology for at least 1,000 hours during the preceding three years in a manner consistent with this chapter; however, such acceptance shall be conditioned upon the certification, registration, or licensure standards in the other state or country being equivalent and satisfactory to the Commission; or

3. (No change in text.)

(b) The Department may deny a license application if the applicant has committed any act or omission specified at N.J.A.C. 7:28-24.12(a).

7:28-24.8      Fusion imaging CT technologist licenses

(a) The Board may issue a license to any applicant who is of good moral character, licensed in nuclear medicine technology pursuant to this subchapter, has paid a fee to the Department as specified in N.J.A.C. 7:28-24.11(b), and has submitted satisfactory evidence, verified by oath or affirmation, that the applicant:

1. Is currently certified in CT by either the American Registry of Radiologic Technologists or Nuclear Medicine Technology Certification Board;

2. Has passed the CT examination of the American Registry of Radiologic Technologists, the Nuclear Medicine Technology Certification Board, or the Board, or an equivalent examination as determined by the Board, within five years prior to the date of the initial license application. If the applicant passed an approved examination more than five years prior to the application, the applicant must provide documentation that he or she has competently engaged in the practice of fusion imaging CT technology for at least 500 hours during the three years preceding the application; or

3. Holds a current certificate, registration, or license as a fusion imaging CT technologist issued by another state, provided the Board determines that the other state's standards are equivalent to those of the Board.

(b) The Board may deny a license application if the applicant has committed any act or omission as specified in N.J.A.C. 7:28-24.12(b).

7:28-24.9   Conditional and restricted licenses

(a) (No change in text.)

(b) The Board, at its discretion, may issue a conditional or restricted license including, but not limited to, a condition or restriction limiting the scope of practice of a licensed fusion imaging CT technologist.

(c) (No change in text.)

7:28-24.10   License expiration and license renewal

(a) No nuclear medicine technologist shall practice without a valid New Jersey nuclear medicine technology license, and no fusion imaging CT technologist shall practice without a valid New Jersey fusion imaging technology license.

(b) A nuclear medicine technologist or fusion imaging CT technologist shall inform the Department of any change in the address of record within 30 calendar days of the change.

(c) In order to maintain a valid license, a nuclear medicine technologist or fusion imaging CT technologist shall renew his or her license biennially by submitting a renewal application for the applicable license and the required renewal fee specified in N.J.A.C. 7:28-24.11.

(d) (No change.)

(e) A renewal application may be denied if the applicant has committed any act or omission specified in N.J.A.C. 7:28-24.12.

(f) A nuclear medicine technologist or fusion imaging CT technologist who possesses an expired license may renew the license, provided that the license has not been expired for more than five years. An individual who wishes to renew an expired license shall submit a renewal application and the current renewal fee to the Department. Such licenses shall be renewed for a period extending from date of renewal to midnight, December 31 of the next even numbered year.

(g) A nuclear medicine technologist who possesses a license that has been expired for more than five years may not have that license renewed, but may apply for a new license through re-examination and other applicable requirements for initial license applications at N.J.A.C. 7:28-24.5 or, if applicable, at N.J.A.C. 7:28-24.7.

(h) A fusion imaging CT technologist who possesses a license that has been expired for more than five years may not have that license renewed, but may apply for a new license through re-examination and other applicable requirements for initial license applications at N.J.A.C. 7:28-24.6 or, if applicable, at N.J.A.C. 7:28-24.8.

7:28-24.11   Fees

(a) Any person who submits a nuclear medicine technology application for an examination, license, or license renewal to the Department shall include as an integral part of the application a service fee as follows:

1.-3. (No change.)

(b) Any person who submits a fusion imaging CT technology application for an examination, license, or license renewal to the Department shall include as an integral part of the application a service fee as follows:

1. Examination application fee:           $ 75.00;

2. Initial license application fee:          $ 40.00;

3. Biennial license renewal fee:            $ 40.00.

(c) All fees shall be in the form of a check or money order made payable to the Treasurer, State of New Jersey, or any other manner acceptable to the Department, as identified on the relevant application or renewal form.

1. The fees submitted to the Department are not refundable and not transferable.

2.-3. (No change.)

7:28-24.12   Examination application or license application denial, license revocation and suspension, and sanctions

(a) The Department, in addition to any penalties authorized by the Act, may deny any examination or license application, and may revoke or suspend a nuclear medicine technology license, when the applicant or licensed nuclear medicine technologist has:

1. Violated any of the provisions of this subchapter, or the Act;

2.-5. (No change.)

(b) The Board, in addition to any penalty authorized by the Act, may, upon learning of any of the acts or omissions listed in (b)1 through 13 below, deny admission to any examination; deny an application for a license in fusion imaging CT technology; revoke or suspend the license of a fusion imaging CT technologist for a fixed period; and censure, reprimand, or otherwise discipline the technologist in accordance with the provisions and procedures set forth in the Radiologic Technologist Act, N.J.S.A. 26:2D-24 et seq.:

1. Violation of any of the provisions of this subchapter or the Act;

2. Conviction of any crime that reasonably relates to fusion imaging CT technology. For the purpose of this section, a plea of guilty, non vult, no contest, or other such disposition of alleged criminal activity shall be deemed a conviction;

3. Revocation or suspension of a certification, registration, or license to fusion imaging CT technology or censure or reprimand by any other state or certifying agency for reasons consistent with this subchapter;

4. Dishonesty, fraud, deception, misrepresentation, or falsification in:

i. Fusion imaging CT technology or in documenting compliance with the Radiation Protection Act, the Radiologic Technologist Act, or this chapter;

ii. Obtaining a fusion imaging CT technology license, including taking the examination and completing the required education and training;

iii. Statements on any fusion imaging CT technology application for examination or license;

iv. Statements or documentation regarding the status of any national certification relating to the field of computed technology;

v. Statements made to a representative of the Department or Board; or

vi. Any records relating to the practice of fusion imaging CT technology;

5. Altering any fusion imaging CT technology license or examination results;

6. Practicing fusion imaging CT technology or reporting to work as a fusion imaging CT technologist while under the influence of alcohol or a Controlled Dangerous Substance as defined in the New Jersey Code of Criminal Justice, N.J.S.A. 2C:1-1 et seq.;

7. Acting in a negligent or incompetent manner relating to fusion imaging CT technology;

8. Maliciously destroying or stealing property or records relating to the practice of fusion imaging CT technology;

9. Failing to exercise due regard for safety, life, or health while engaged in the practice of fusion imaging CT technology;

10. Violating any term limitation, condition, or restriction that the Board has placed on his or her fusion imaging CT technology license;

11. Failing to comply with any State or Federal law or regulation regarding the confidentiality of a patient's medical or dental information;

12. Impersonating a licensed fusion imaging CT technologist;

13. Discriminating in the practice of fusion imaging CT technology as defined in Section 3 of New Jersey Law Against Discrimination, N.J.S.A. 10:5-3, as supplemented or amended.

(c) There is a rebuttable presumption that a person who has been determined by the Board to have committed an act or omission listed in (b) above or has been convicted of a crime involving moral turpitude does not meet the standard of good moral character. A person may rebut the presumption by demonstrating to the Board's satisfaction that he or she is of good moral character.

(d) (No change in text.)

7:28-24.13   School of nuclear medicine technology; standards

(a) In order to be approved by the Department in accordance with N.J.A.C. 7:28-24.14, a school of nuclear medicine technology shall be accredited by JRCNMT, or by an accreditation agency that the Department determines is equivalent, and shall maintain that accreditation.

(b) The school's curriculum shall comply with JRCNMT's standards, or standards that the Department determines are equivalent, and include a valid plan for competency-based clinical education as follows:

1. Nuclear medicine students shall:

i. Perform nuclear medicine procedures under the direct supervision of a licensed nuclear medicine technologist until a school instructor determines that the student has achieved competency in that procedure; and

ii. Perform nuclear medicine procedures for which the student has demonstrated competency in accordance with (b)1i above under either the direct or indirect supervision of a licensed nuclear medicine technologist, as provided in the school's curriculum.

2. Students who perform CT procedures as part of the school's curriculum shall perform these procedures under the direct supervision of a licensed physician or a licensed diagnostic radiologic technologist, or a licensed fusion imaging CT technologist if the CT procedure is part of a fusion imaging procedure.

(c) Neither the school nor its clinical education centers shall assign students to clinical education rotations in such a manner as to substitute for licensed technologists.

(d) The school shall assign students only to clinical education centers that are approved by the Department.

(e) The school shall not have more than two consecutive calendar years in which the pass rate for students taking the American Registry of Radiologic Technologists or Nuclear Medicine Technology Certification Board examination for the first time is below 75 percent.

(f) The school shall forward to the Department a copy of its annual examination report from the American Registry of Radiologic Technologists or Nuclear Medicine Technology Certification Board within 15 calendar days of receipt of the report.

(g) The school shall inform the Department within 15 calendar days after any change that could adversely affect the school's ability to fulfill its responsibility to provide students with appropriate didactic and laboratory instruction and clinical assignments. Such changes include, but are not limited to, a change in status or loss of any official or faculty member, the loss of a clinical education center, a change in the school's curriculum, the sequencing of courses or length of the program, or a change in the sponsorship of the program.

(h) The school shall notify the Department of any change in its accreditation status and the reason for such change no later than seven calendar days after the school is notified of the change in its accreditation status.

(i) The school shall provide the Department in writing the name and address of each new student enrolled in the school's course of study in nuclear medicine technology no later than 30 calendar days after the student's enrollment. The school shall provide the Department in writing the name and address of each student who has successfully completed the school's course of study in nuclear medicine technology no later than 30 calendar days after the student completes the course of study.

(j) The school shall provide all students with whole body and finger radiation monitoring devices and ensure that the devices are worn during all times when students are in a controlled area. Student exposure to radiation shall not exceed the occupational limits and, if applicable, the embryo-fetus exposure limit prescribed in the standards for protection against radiation at N.J.A.C. 7:28-6.1. In the event that a student or embryo-fetus receives an exposure that exceeds the exposure limit, the school shall, within seven calendar days, notify the Department.

(k) The school, including its clinical education centers, shall:

1. Permit the Department to conduct site inspections;

2. Make available to the Department such information, records, or persons that may be needed to determine compliance with the requirements of this subchapter; and

3. Demonstrate to the satisfaction of the Department that it complies with the requirements of this subchapter.

7:28-24.14   School of nuclear medicine technology; process for approval and termination

(a) In order to be approved by the Department, a school of nuclear medicine technology shall submit to the Department a complete application, which shall include:

1. The name, address, and contact information of the school;

2. The name and credentials of the program director;

3. The name and address of all clinical education centers;

4. A copy of the school's accreditation letter from JRCNMT or an equivalent accreditation agency;

5. Copies of policies governing the supervision of students that comply with N.J.A.C. 7:28-24.13(b);

6. The last three annual examination reports of the school's nuclear medicine technology graduates' first-time examination performance on the American Registry of Radiologic Technologists or Nuclear Medicine Technology Certification Board. A school that has graduated students for less than three years shall submit the most recent annual examination reports, if any; and

7. A written statement permitting Department inspection pursuant to N.J.A.C. 7:28-24.13(k).

(b) The Department shall approve the application if it determines that the school has complied with this subchapter.

(c) Any change to the information contained in school's approved application shall be reported to the Department within 15 calendar days after the change.

(d) A school whose application has been denied shall be notified by letter, via certified mail, which shall contain the findings that resulted in the denial.

(e) Schools that are approved by the Department on or before *[(one day prior to the operative date of the rules)]* *March 6, 2016* are deemed approved.

(f) In order to maintain approval, the school shall comply with the requirements of this subchapter.

(g) A school may have its approval terminated by the Department for failure to comply with this subchapter. The Department shall notify the school via certified mail. The notice shall include the findings that led to the termination and specify the effective date of the termination.

7:28-24.15   List of approved schools

A list of approved schools of nuclear medicine technology and their approval status shall be available from the Department, and may be obtained by contacting the Department. (See N.J.A.C. 7:28-24.11(d)2 for the Department's address.)

7:28-24.16   Adjudicatory hearings

(a) Subject to the limitation on third-party hearing rights at (e) below, an applicant for examination, initial license, or license renewal; a licensed technologist; a school of nuclear medicine technology; or any person aggrieved by any Department or Board finding or administrative order may contest the finding or administrative order and request an adjudicatory hearing. The request shall be made in writing to the Department at the address at (d) below no later than 20 calendar days after receipt of the Department's or Board's findings or administrative order. The person or school requesting the hearing shall include the following information in each hearing request:

1. The name, address, and telephone number of the person or school and any authorized representative;

2. The date the person or school received the Department's or Board's finding;

3. A copy of the finding or administrative order giving rise to the request for a hearing, and a list of all issues being appealed;

4. The defenses to each of the Department's or Board's findings of fact, stated in short and plain terms;

5. An admission or denial of each of the Department's or Board's findings. If the person or school is without knowledge or information sufficient to form a belief as to the truth of a finding, the person or school shall so state and this shall have the effect of a denial. A denial shall fairly meet the substance of the findings denied. When the person or school intends in good faith to deny only a part or a qualification of a finding, the person or school shall specify so much of it as is true and material and deny only the remainder. The person or school may not generally deny all of the findings, but shall make all denials as specific denials of designated findings. For each finding the person or school denies, the person or school shall state the fact or facts as the person or school believes it or them to be;

6. Information supporting the request and specific reference to or copies of other written documents relied upon to support the request;

7. An estimate of the time required for the hearing (in days and/or hours); and

8. A request, if necessary, for a barrier-free hearing location for physically disable*d* persons.

(b) The Department shall deny the hearing request if:

1. The person or school requesting the hearing fails to include all of the information required in (a) above; or

2. The Department does not receive the request in the time specified in (a) above.

(c) The Department shall conduct all adjudicatory hearings in accordance with the Administrative Procedure Act, N.J.S.A. 52:14B-1 et seq., and the Uniform Administrative Procedure Rules, N.J.A.C. 1:1.

(d) Requests for adjudicatory hearings shall be sent to:

   New Jersey Department of Environmental Protection
   Office of Legal Affairs
   Attention: Hearing Request
   401 East State Street, 7th Floor
   Mail Code 401-04L
   PO Box 402
   Trenton, New Jersey 08625-0402; and

   New Jersey Department of Environmental Protection
   Bureau of X-ray Compliance
   Attention: Hearing Request
   Mail Code 25-01
   PO Box 420
   Trenton, New Jersey 08625-0420

(e) Nothing in this section shall be construed to provide a right to an adjudicatory hearing in contravention of N.J.S.A. 52:14B-3.1 through 3.3.

7:28-24.17   Severability

Each section of this subchapter is severable. In the event that any section, subsection or division, or application thereof, is held invalid in a court of law, the remainder of this subchapter shall continue in full force and effect.

SUBCHAPTER 58.     DOMESTIC LICENSING OF SOURCE MATERIAL

7:28-58.1   Incorporation by reference

(a)-(b) (No change.)

(c) In addition to the changes outlined in N.J.A.C. 7:28-1.6, the following provisions of 10 CFR Part 40 are incorporated by reference with the specified changes:

1.-10. (No change.)

11. 10 CFR 40.22(b)(3), replace "§§ 40.1 through 40.10" with "§§ 40.1, 40.2, 40.3, 40.4, 40.6 and 40.7, 40.9 and 40.10," and replace "40.41 (a) through (e)" with "40.41(a) through (c) and (e)(2)";

12.-22. (No change.)

23. 10 CFR 40.36(d)(1)(i)(B), replace "20.1402" with "N.J.A.C. 7:28-12.1," add "or restricted" after "unrestricted," and delete ", provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of 10 CFR 20.1403, the cost estimate may be based on meeting the 10 CFR 20.1403 criteria";

24.-38. (No change.)

(d)-(g) (No change.)

SUBCHAPTER 60.     DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL

7:28-60.1   Incorporation by reference

(a) (No change.)

(b) The following provisions of 10 CFR Part 70 are not incorporated by reference. If there is a cross reference to a Federal citation specifically entirely excluded from incorporation, then the cross referenced citation is not incorporated by virtue of the cross reference:

1.-35. (No change.)

36. 10 CFR 70.91, Violations; *[and]*

37. 10 CFR 70.82, Suspension and operation in war or national emergency*[.]**; and

38. Appendix A.*

(c) In addition to the changes outlined in N.J.A.C. 7:28-1.6, the following provisions of 10 CFR Part 70 are incorporated by reference with the specified changes:

1.-13. (No change.)

14. 10 CFR 70.25(e)(1)(i)(B), replace "20.1402" with "N.J.A.C. 7:28-12.1," add "or restricted" after "unrestricted," and delete ", provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of 10 CFR 20.1403, the cost estimate may be based on meeting the 10 CFR 20.1403 criteria";

15.-26. (No change.)

(d)-(f) (No change.)

SUBCHAPTER 61.     PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIALS

7:28-61.1   Incorporation by reference

(a)-(b) (No change.)

(c) In addition to the changes outlined in N.J.A.C. 7:28-1.6, the following provisions of 10 CFR 71 are incorporated by reference with the specified changes:

1. "Commission," "Nuclear Regulatory Commission," "NRC," and "U.S. Nuclear Regulatory Commission," as used in the provisions of Part 71 of the Code of Federal Regulations that are incorporated by reference, means the Department, except at:

i.-ii. (No change.)

*[iii. 10 CFR 71.85(c), Preliminary determinations;]*

*iii. 10 CFR 71.17;*

iv.-vi. (No change.)

vii. 10 CFR 71.97(c)(1), (c)(3)(iii), and (f), Advance notification of shipment of irradiated reactor fuel and nuclear waste; *and*

viii. 10 CFR 71.101(f), Quality assurance requirements; *[and

ix. 10 CFR 71.106;]*

2.-4. (No change.)

*5. 10 CFR 71.4, in definition of special form radioactive material, N.J.A.C. 7:28-1.6(i) shall not apply to replace references to past versions of Part 71 with N.J.A.C. 7:28-61;*

Recodify existing  5.-15. as *6.-16.* (No change in text.)

(d)-(e) (No change.)

SUBCHAPTER 65.     PHYSICAL PROTECTION OF CATEGORY 1 AND CATEGORY 2 QUANTITIES OF RADIOACTIVE MATERIAL

7:28-65.1   Incorporation by reference

(a) Except as set forth in (b) and (c) below, this subchapter incorporates by reference 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material.

(b) The following provisions of 10 CFR Part 37 are not incorporated by reference. If there is a cross-reference to a Federal citation specifically entirely excluded from incorporation, then the cross-referenced citation is not incorporated by virtue of the cross-reference:

1. 10 CFR 37.11(b).

(c) In addition to the changes in N.J.A.C. 7:28-1.6, the following provisions of 10 CFR Part 37 are incorporated by reference with the specified changes:

1. "Commission," "Nuclear Regulatory Commission," "NRC," and "U.S. Nuclear Regulatory Commission," as used in the following provisions of Part 37 of the Code of Federal Regulations that are incorporated by reference, mean the "U.S. Nuclear Regulatory Commission":

i. 10 CFR 37.5 in definition*s* of *"Agreement State" and* "fingerprint orders";

ii. 10 CFR 37.25(b)(2);

iii. 10 CFR 37.27(a);

iv. 10 CFR 37.27(c)(1) through (3);

v. 10 CFR 37.29(a)(1);

vi. 10 CFR 37.29(a)(7);

vii. 10 CFR 37.29(a)(8);

viii. 10 CFR 37.71; and

ix. 10 CFR 37.77*(a)(1), limited to the NRC website and address for obtaining contact information for the office of each appropriate governor or governor's designee*.

2. "Security Orders," as used in 10 CFR Part 37, means the license conditions imposed in NJ Radioactive Materials licenses that implement NRC's Orders Imposing Fingerprinting (EA-07-305).

3. 10 CFR 37.5 Definitions, "Atomic Energy Act of 1954," or "Act" shall mean "Atomic Energy Act of 1954" in the following instances:

*i. 10 CFR 37.5 in definition of "Agreement State" ;*

*[i.]* *ii.* 10 CFR 37.29(a);

*[ii.]* *iii.* 10 CFR 37.29(a)(7); and

*[iii.]* *iv.* 10 CFR 37.29(b);

4. 10 CFR 37.5, Definitions, in the definition of "fingerprint orders," delete "or the legally binding requirements issued by Agreement States";

5. 10 CFR 37.5, Definitions, in the definition of "license issuing authority," replace "or the appropriate agency of an Agreement State" with "the U.S. Nuclear Regulatory Commission or the appropriate agency of an Agreement State";

6. 10 CFR 37.5, Definitions, in the definition of "person," replace "Government agency" with "state or local government agency" and delete "other than the Commission or the DOE except that the Department shall be considered a person within the meaning of the regulations in 10 CFR chapter I to the extent that its facilities and activities are subject to the licensing and related regulatory authority of the Commission under section 202 of the Energy Reorganization Act of 1974 (88 Stat. 1244), the Uranium Mill Tailings Radiation Control Act of 1978 (92 Stat. 3021), the Nuclear Waste Policy Act or 1982 (96 Stat. 2201), and section 2(b)(2) of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (99 Stat. 1842), and any State or any political subdivision of or any political entity within a State, any foreign government or nation or any political subdivision of any such government or nation, or other entity";

*[7. 10 CFR 37.43(d)(1), delete "Except as provided in paragraph (d)(9)";]*

*[8.]* *7.* 10 CFR 37.77 (a)(1), replace "The notification to the NRC may be made by email to RAMQC_SHIPMENTS@nrc.gov or by fax to 301-816-5151" with "The notification to the Bureau of Environmental Radiation may be made by email to RAMQC@dep.nj.gov or by fax at the number provided at N.J.A.C. 7:28-1.5(b)"; and

*[9.]* *8.* 10 CFR 37.81(g), delete "In addition, the licensee shall provide one copy of the written report addressed to the Director, Division of Security Policy, Office of Nuclear Security and Incident Response, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001."