RULES AND REGULATIONS
Title 25—ENVIRONMENTAL PROTECTION
ENVIRONMENTAL QUALITY BOARD
[ 25 PA. CODE CHS. 215, 217, 230 AND 232 ]
U.S. Nuclear Regulatory Commission (NRC) Consistency Rule
[48 Pa.B. 5723]
[Saturday, September 15, 2018]The Environmental Quality Board (Board) amends Chapters 215, 217, 230 and 232 to exclude specific provisions of 10 CFR 1.1—171.25 (relating to Nuclear Regulatory Commission) from incorporation-by-reference in these Chapters as set forth in Annex A.
Notice of proposed rulemaking is omitted under section 204 of the act of July 31, 1968 (P.L. 769, No. 240) (45 P.S. § 1204), known as the Commonwealth Documents Law (CDL). Section 204(3) of the CDL provides that an agency may omit the notice of proposed rulemaking if ''the agency for good cause finds. . .that the [public notice and comment] procedures specified in sections 201 and 202 are in the circumstances impracticable, unnecessary, or contrary to the public interest.'' The amendments in this final-omitted rulemaking are necessary to exclude Federal provisions that purport to give the Department of Environmental Protection (Department) legal authority that it does not have. The specific provisions that this final-omitted rulemaking addresses have never been enforced by the Department because the enforcement authority resides with the Nuclear Regulatory Commission (NRC). Review and consideration of public comments on the amendments are unnecessary and contrary to the public interest because public comments would delay the required clarification of the Department's proper authority under Federal law. Public comments could not alter the need to make these amendments and there is no need to alter the formatting of the amendments. Finalizing these amendments without public notice and comment is in the public interest to ensure that the Commonwealth's regulations accurately reflect the Department's authority in an expeditious manner. Likewise, finalizing these amendments without public notice and comment is in the interest of those holding radioactive material licenses in the Commonwealth because the amendments clarify the proper authority of the Department and the NRC under the agencies' respective Radioactive Materials Programs (Program). No changes to any radioactive material license will result from this final-omitted rulemaking.
This final-omitted rulemaking was adopted by the Board at its meeting of June 19, 2018.
A. Effective Date
This final-omitted rulemaking will be effective upon publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information, contact John Chippo, Program Manager, Division of Radiation Control, P.O. Box 8469, Rachel Carson State Office Building, Harrisburg, PA 17105-8469, (717) 787-2480; or Robert Schena, Assistant Counsel, Bureau of Regulatory Counsel, P.O. Box 8464, Rachel Carson State Office Building, Harrisburg, PA 17105-8464, (717) 783-8072. Persons with a disability may use the Pennsylvania AT&T Relay Service, (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This final-omitted rulemaking is available on the Department's web site at www.dep.pa.gov (select ''Public Participation,'' then ''Environmental Quality Board (EQB)'').
C. Statutory Authority
This final-omitted rulemaking is being made under the authority of section 301 of the Radiation Protection Act (RPA) (35 P.S. § 7110.301) which designates the Department as the agency of the Commonwealth responsible for regulation and control of radiation. Section 302 of the RPA (35 P.S. § 7110.302) which grants the Board the authority to adopt rules and regulations to accomplish the purposes and carry out the provisions of the RPA. Section 1920-A of the Administrative Code (71 P.S. § 510-20) which grants the Board the authority to adopt rules and regulations for the proper performance of the work of the Department.
D. Background and Purpose
The Commonwealth and the NRC entered into an agreement in 2008 in which the Commonwealth agreed to oversee and regulate most types of radioactive materials used in the Commonwealth. This agreement gave the Commonwealth status as an ''Agreement State.'' As part of that agreement, the Commonwealth's Program must remain compatible with the NRC's Program, under 42 U.S.C.A. § 2021(d)(2) (relating to cooperation with states). The Commonwealth meets this requirement by incorporating the appropriate NRC regulations by reference in 25 Pa. Code Part I, Subpart D, Article V (relating to radiological health). The NRC recently identified provisions of 10 CFR that should be excluded from the Commonwealth's incorporation-by-reference in Chapters 215, 217, 230 and 232. These amendments are necessary for the Commonwealth's program to remain compatible with the NRC Program because the citations to 10 CFR that the Board is excluding can only be implemented by the NRC.
The failure to exclude these sections from the Commonwealth's incorporation-by-reference of select Federal regulations was a mistake in the 2008 rulemaking (38 Pa.B. 2243 (May 17, 2008)) promulgated to support the 2008 agreement with the NRC. Examples of Federal provisions excluded by these amendments are: portions of the definitions of terms such as ''construction'' and ''commencement of construction'' dealing with national defense; provisions involving the sale and distribution of radioactive material in certain industrial devices across state lines; regulations concerning high concentration of radioactive source material or special nuclear material, such as uranium and plutonium; and provisions regarding the transportation and distribution of exempt consumer materials. The Department does not have the authority under the 2008 agreement to implement these sections and has never enforced them. These amendments clarify the proper authority of the Department and the NRC under their respective regulations.
In addition, the amendments add an exception regarding notifications, reports and correspondence to be directed to the Department.
The Department presented this final-omitted rulemaking to the Radiation Protection Advisory Committee (RPAC) at its October 19, 2017, meeting. At that meeting, the RPAC recommended that the Department move forward with this final-omitted rulemaking.
E. Summary of the Final-Omitted Rulemaking
References to the provisions of 10 CFR that are now being eliminated from incorporation-by-reference in Chapters 215, 217, 230 and 232 in this final-omitted rulemaking are outlined, by section, in the following table:
25 Pa. Code Section
Amended
10 CFR Provision
Excluded from Incorporation-by-Reference
§§ 215.1(e)(3) and 217.131(b) Paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 30.4 §§ 215.1(e)(5) and 217.151(b) Sections 32.1(c)(1), 32.30, 32.31 and 32.32 §§ 215.1(e)(9) and 232.2(b) Paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 36.2 § 215.1(e)(12) Sections 40.13(c)(5)(iv), 40.52, 40.53, Part 40 Appendix A Criterion 11 A—F and Criterion 12, and paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 40.4. § 215.1(e)(13) Section 70.74, Part 70 Appendix A, and paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 70.4 § 215.1(e)(14) The definitions of ''certificate holder'' and ''certificate of compliance (CoC)'' in section 71.4. The term ''applicant'' when used in 10 CFR Part 71. § 217.171(b) Sections 40.13(c)(5)(iv), 40.52, 40.53, and paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 40.4 § 217.181(b) Section 70.74, Part 70 Appendix A, and paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 70.4 § 230.3(b) The definitions of ''certificate holder'' and ''certificate of compliance (CoC)'' in section 71.4. The term ''applicant'' when used in 10 CFR Part 71.
In addition, this final-omitted rulemaking amends § 215.1(h)(5) to add an exception in 10 CFR 71.17(c)(3) (relating to general license: NRC-approved package) regarding notifications, reports and correspondence that would otherwise be directed to the Department.
F. Benefits, Costs and Compliance
Benefits
The fundamental benefit of this final-omitted rulemaking is ensuring that the Commonwealth's regulations meet the requirements of the NRC's Agreement State Program, as required by Federal law (42 U.S.C.A. § 2021(d)(2)). If these amendments are not adopted, the Commonwealth will be at risk of losing the authority it assumed as an Agreement State under the 2008 agreement to regulate most types of radioactive materials used in the Commonwealth.
Compliance Costs
The amendments will create no compliance costs. No additional financial, economic or social impact will result from these amendments.
Compliance Assistance Plan
No compliance assistance is necessary for implementation of this final-omitted rulemaking because the regulated community remains subject to the requirements deleted from the Commonwealth's regulations at the Federal level.
Paperwork Requirements
This final-omitted rulemaking will not revise paperwork requirements.
G. Pollution Prevention
Pollution prevention is not applicable to this rulemaking.
H. Sunset Review
The Board is not establishing a sunset date for these amended regulations because the amendments are needed for the regulations to accurately reflect the Department's legal authority and for the Department to meet its obligations under Federal law.
I. Regulatory Review
Under section 5.1(c) of the Regulatory Review Act (71 P.S. § 745.5a(c)), on July 16, 2018, the Department submitted a copy of this final-omitted rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House and Senate Environmental Resources and Energy Committees. On the same date, the regulations were submitted to the Office of Attorney General for review and approval under the Commonwealth Attorneys Act (71 P.S. §§ 732-101—732-506).
Under section 5.1(j.2) of the Regulatory Review Act, on August 15, 2018, the final-omitted rulemaking was deemed approved by the House and Senate Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on August 16, 2018, and approved the final-omitted rulemaking.
J. Findings
The Board finds that:
(1) The amendments as set forth in Annex A are appropriate to remain compatible with the requirements of the NRC's Agreement State program.
(2) Use of the omission of notice of proposed rulemaking procedure is appropriate because the proposed rulemaking procedures specified in sections 201 and 202 of the CDL (45 P.S. §§ 1201 and 1202) are, in this instance, impracticable, unnecessary, or contrary to the public interest.
(3) No radioactive licensees are affected by this final-omitted rulemaking.
(4) These amendments are necessary and appropriate for administration and enforcement of the authorizing acts identified in section C of this preamble and are in the public interest.
K. Order
The Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 25 Pa. Code Chapters 215, 217, 230 and 232, are amended by amending §§ 215.1, 217.131, 217.151, 217.171, 217.181, 230.3 and 232.2 to read as set forth in Annex A, with ellipses referring to the original text of the regulation.
(b) The Chairperson of the Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for review and approval as to legality and form, as required by law.
(c) The Chairperson of the Board shall submit this order and Annex A to IRRC and the Senate and House Environmental Resources and Energy Committees as required by the Regulatory Review Act (71 P.S. §§ 745.1—745.14).
(d) The Chairperson of the Board shall certify this order and Annex A, as approved to legality and form, and deposit them with the Legislative Reference Bureau, as required by law.
(e) This order shall take effect immediately upon publication in the Pennsylvania Bulletin.
PATRICK McDONNELL,
Chairperson(Editor's Note: See 48 Pa.B. 5576 (September 1, 2018) for IRRC's approval order.)
Fiscal Note: 7-550. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 25. ENVIRONMENTAL PROTECTION
PART I. DEPARTMENT OF ENVIRONMENTAL PROTECTION
Subpart D. ENVIRONMENTAL HEALTH AND SAFETY
ARTICLE V. RADIOLOGICAL HEALTH
CHAPTER 215. GENERAL PROVISIONS § 215.1. Purpose and scope.
(a) This article establishes requirements for the protection of public health and safety as related to radiation sources and implements the requirements of the act.
(b) This article, except as otherwise specifically provided in the act, applies to persons who use, manufacture, produce, transport, transfer, receive, acquire, possess, own or dispose of a radiation source.
(c) A person who, when required, fails to register or obtain a license for radiation sources in the possession or control of the person, shall comply with the act or with this article.
(d) This article does not apply to the extent the person is subject to regulation by the NRC.
(e) Title 10 Chapter I (Nuclear Regulatory Commission) Parts 19, 20, 30, 31, 32, 33, 34, 35, 36, 37, 39, 40, 70, 71 and §§ 150.1, 150.2, 150.3, 150.11 and 150.20 of the CFR are incorporated by reference with the exceptions set forth in paragraphs (1)—(14). Notwithstanding the requirements incorporated by reference, nothing in this article relieves or limits a person from complying with the laws of the Commonwealth, including the act and the Low-Level Radioactive Waste Disposal Act (35 P.S. §§ 7130.101—7130.905).
(1) Sections 19.4, 19.5, 19.8, 19.30 and 19.40 are not incorporated.
(2) Sections 20.1006, 20.1009, 20.2206(a)(1), (3), (4) and (5), 20.2401 and 20.2402 are not incorporated.
(3) Sections 30.5, 30.6, 30.8, 30.21(c), 30.34(d) and (e)(1) and (3), 30.41(b)(6), 30.55, 30.63 and 30.64 are not incorporated. Paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 30.4 are not incorporated.
(4) Sections 31.4 and 31.14 are not incorporated.
(5) Sections 32.1(c)(1), 32.8, 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, 32.21, 32.22, 32.23, 32.25, 32.26, 32.27, 32.28, 32.29, 32.30, 32.31, 32.32 and 32.40 are not incorporated.
(6) Sections 33.8, 33.21 and 33.23 are not incorporated.
(7) Sections 34.5, 34.8, 34.121 and 34.123 are not incorporated.
(8) Sections 35.8, 35.4001 and 35.4002 are not incorporated.
(9) Sections 36.5, 36.8, 36.91 and 36.93 are not incorporated. Paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 36.2 are not incorporated.
(10) Sections 37.3(b)(2), 37.13, 37.73(d) and (e), 37.107 and 37.109 are not incorporated.
(11) Sections 39.5, 39.8, 39.101 and 39.103 are not incorporated.
(12) Sections 40.6, 40.8, 40.12(b), 40.13(c)(5)(iv), 40.23, 40.27, 40.28, 40.31(k) and (i), 40.32(d), (e) and (g), 40.33, 40.38, 40.41(d), (e)(1) and (3) and (g), 40.51(b)(6), 40.52, 40.53, 40.64, 40.66, 40.67, 40.81, 40.82 and 10 CFR Part 40 Appendix A Criterion 11 A—F and Criterion 12 are not incorporated. Paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 40.4 are not incorporated.
(13) Sections 70.1(c), (d) and (e), 70.5, 70.6, 70.8, 70.13, 70.13a, 70.20a, 70.20b, 70.21(a)(1), (c), (f), (g) and (h), 70.22(b), (c), (f), (g), (h), (i), (j), (k), (l), (m) and (n), 70.23(a)(6), (7), (8), (9), (10), (11) and (12) and (b), 70.23a, 70.24, 70.25(a), 70.31(c), (d) and (e), 70.32(a)(1), (4), (5), (6) and (7), 70.32(b)(1), (3) and (4), (c), (d), (e), (f), (g), (h), (i), (j) and (k), 70.37, 70.40, 70.42(b)(6), 70.44, 70.51(c), (d) and (e), 70.52, 70.53, 70.54, 70.55(c)(1), (2) and (3), 70.56(c) and (d), 70.57, 70.58, 70.59, 70.62, 70.71, 70.72, 70.74, and 10 CFR Part 70 Appendix A are not incorporated. Paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 70.4 are not incorporated.
(14) Sections 71.2, 71.6, 71.14(b), 71.19, 71.31, 71.33, 71.35, 71.37, 71.38, 71.39, 71.41, 71.43, 71.45, 71.51, 71.55, 71.59, 71.61, 71.63, 71.64, 71.65, 71.71, 71.73, 71.74, 71.75, 71.77, 71.99, 71.100, 71.101 (c)(2), (d) and (e), 71.107, 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123 and 71.125 are not incorporated. The definitions of ''certificate holder'' and ''certificate of compliance (CoC)'' in section 71.4 are not incorporated. The term ''applicant'' when used in 10 CFR Part 71 is not incorporated.
(f) If a provision of the CFR incorporated by reference in this article includes a section which is inconsistent with this title, this title controls to the extent Federal law does not preempt Commonwealth law. If a provision of the CFR incorporated by reference in this article is beyond the scope of authority granted the Department under statute, or is in excess of the statutory authority, the provisions shall be and remain effective only to the extent authorized by the Pennsylvania law.
(g) Appropriate parts of 10 CFR (relating to energy) may be obtained from the following:
(1) The United States Government Printing Office, Book Store, Room 118, Federal Building, 1000 Liberty Avenue, Pittsburgh, Pennsylvania 15222, (412) 664-2721.
(2) The United States Government Printing Office, Book Store, 100 North 17th Street, Robert Morris Building, Philadelphia, Pennsylvania 19103, (215) 597-0677.
(3) The United States Superintendent of Documents, United States Government Printing Office, Washington, D.C. 20402, (202) 783-3238.
(h) To reconcile differences between this chapter and the incorporated sections of Federal regulations and to effectuate their joint enforcement, the following words and phrases shall be substituted for the language of the Federal regulations:
(1) A reference to ''NRC'' or ''Commission'' means Department.
(2) A reference to ''NRC or agreement state'' means Department, NRC or agreement state.
(3) The definition of ''sealed source'' includes NARM.
(4) A reference to ''byproduct material'' includes NARM.
(5) Notifications, reports and correspondence referenced in the incorporated parts of 10 CFR shall be directed to the Department, except as noted in 10 CFR 37.27 (relating to requirements for criminal history records checks of individuals granted unescorted access to category 1 or category 2 quantities of radioactive material) and in 10 CFR 71.17(c)(3) (relating to general license: NRC-approved package).
CHAPTER 217. LICENSING OF RADIOACTIVE MATERIAL § 217.131. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 30 (relating to rules of general applicability to domestic licensing of byproduct material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 30.5, 30.6, 30.8, 30.21(c), 30.34(d), (e)(1) and (3), 30.41(a)(6), 30.55, 30.63 and 30.64 are not incorporated by reference. Paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 30.4 are not incorporated.
§ 217.151. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 32 (relating to specific domestic licenses to manufacture or transfer certain items containing byproduct material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 32.1(c)(1), 32.8, 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, 32.21, 32.22, 32.23, 32.25, 32.26, 32.27, 32.28, 32.29, 32.30, 32.31, 32.32 and 32.40 are not incorporated by reference.
§ 217.171. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 40 (relating to domestic licensing of source material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 40.6, 40.8, 40.12(b), 40.13(c)(5)(iv), 40.23, 40.27, 40.28, 40.31(k) and (i), 40.32(d), (e) and (g), 40.33, 40.38, 40.41(d), (e)(1) and (3) and (g), 40.51(b)(6), 40.52, 40.53, 40.64, 40.66, 40.67, 40.81 and 40.82 are not incorporated by reference. Paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 40.4 are not incorporated.
§ 217.181. Incorporation by reference.
(a) Except as provided in this subchapter, the requirements of 10 CFR Part 70 (relating to domestic licensing of special nuclear material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 70.1(c), (d) and (e), 70.5, 70.6, 70.8, 70.13, 70.13a, 70.20a, 70.20b, 70.21(a)(1), (c), (f), (g) and (h), 70.22(b), (c), (f), (g), (h), (i), (j), (k), (l), (m) and (n), 70.23(a)(6), (7), (8), (9), (10), (11) and (12) and (b), 70.23a, 70.24, 70.25(a), 70.31(c), (d) and (e), 70.32(a)(1), (4), (5), (6) and (7) and (b)(1), (3) and (4) and (c), (d), (e), (f), (g), (h), (i), (j) and (k), 70.37, 70.40, 70.42(b)(6), 70.44, 70.51(c), (d) and (e), 70.52, 70.53, 70.54, 70.55(c)(1), (2) and (3), 70.56(c) and (d), 70.57, 70.58, 70.59, 70.62, 70.71, 70.72, 70.74 and 10 CFR Part 70 Appendix A are not incorporated by reference. Paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 70.4 are not incorporated.
CHAPTER 230. PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL § 230.3. Incorporation by reference.
(a) Except as provided in this chapter, the requirements of 10 CFR Part 71 (relating to packaging and transportation of radioactive material) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, 10 CFR 71.2, 71.6, 71.14(b), 71.19, 71.31, 71.33, 71.35, 71.37, 71.38, 71.39, 71.41, 71.43, 71.45, 71.51, 71.55, 71.59, 71.61, 71.63, 71.64, 71.65, 71.71, 71.73, 71.74, 71.75, 71.77, 71.99, 71.100, 71.101(c)(2), (d) and (e), 71.107, 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123 and 71.125 are not incorporated by reference. The definitions of ''certificate holder'' and ''certificate of compliance (CoC)'' in section 71.4 are not incorporated. The term ''applicant'' when used in 10 CFR Part 71 is not incorporated.
CHAPTER 232. LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS § 232.2. Incorporation by reference.
(a) Except as provided in this chapter, the requirements of 10 CFR Part 36 (relating to licenses and radiation safety requirements for irradiators) are incorporated by reference.
(b) Notwithstanding the requirements incorporated by reference, §§ 36.5, 36.8, 36.91 and 36.93 are not incorporated by reference. Paragraph 2 of the definition of ''commencement of construction'' and paragraph 9(ii) of the definition of ''construction'' in section 36.2 are not incorporated.
[Pa.B. Doc. No. 18-1447. Filed for public inspection September 14, 2018, 9:00 a.m.]
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