RULES AND REGULATIONS
Title 25—ENVIRONMENTAL PROTECTION
ENVIRONMENTAL QUALITY BOARD
[25 PA. CODE CH. 218]
Radiological Health Fees
[53 Pa.B. 3324]
[Saturday, June 24, 2023]The Environmental Quality Board (Board) amends Chapter 218 (relating to fees). This final-form rulemaking amends the annual fees for radiation-producing machine registrations, vendor registrations, accelerator licenses, radioactive material licenses and the professional hourly rate.
This final-form rulemaking was adopted by the Board at its meeting of April 11, 2023.
A. Effective Date
This final-form rulemaking will be effective 30 days after publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information contact John Chippo, Chief, Division of Radiation Control, P.O. Box 8469, Rachel Carson State Office Building, Harrisburg, PA 17105-8469, (717) 787-2480, or Nicholas Pistory, Assistant Counsel, Bureau of Regulatory Counsel, P.O. Box 8464, Rachel Carson State Office Building, Harrisburg, PA 17105-8464, (717) 787-9372. Persons with a disability may use the Pennsylvania Hamilton Relay Service, (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This final-form rulemaking is available on the Department of Environmental Protection's (Department) web site at www.dep.pa.gov (select ''Public Participation,'' then ''Environmental Quality Board'' and then navigate to the Board meeting of April 11, 2023).
C. Statutory Authority
This final-form rulemaking is authorized under sections 301, 302 and 401 of the Radiation Protection Act (RPA) (35 P.S. §§ 7110.301, 7110.302 and 7110.401), which direct the Board and the Department to establish fees in amounts at least sufficient to cover the costs of the radiation protection programs mandated by the RPA and review of those fees every 3 years, and under section 1920-A of The Administrative Code (71 P.S. § 510-20), which directs the Board ''. . .to formulate, adopt and promulgate such rules and regulations as may be determined by the board for the proper performance of the work of the Department. . . .''
D. Background and Purpose
The Department's Radiation Protection Program (RPP) was established to carry out the comprehensive program of radiation protection in this Commonwealth as required by the RPA (35 P.S. §§ 7110.101—7110.703). Section 401 of the RPA and section 8 of the Radon Certification Act (63 P.S. § 2008) require that fees be established to cover the Department's RPP costs. Section 302(b) of the RPA (35 P.S. § 7110.302(b)) requires the Board to review the radiation protection fee structure every 3 years.
On February 15, 2022, the Department presented its Three-Year Regulatory Fee and Program Cost Analysis Report (Report) in accordance with § 218.11(l) (relating to registration, renewal of registration and license fees) and Chapter 240, Appendix A (relating to radon certification fee schedule) to the Board. The Report covered the period of 2018—2021 and analyzed costs for three program areas: Accelerator, Radiation-Producing Machines, and Vendors/Service Providers; Radioactive Materials and Decommissioning; and Radon. The Department concluded that fee increases are necessary for the Accelerator, Radiation-Producing Machines, and Vendors/Service Providers Program and for the Radioactive Materials and Decommissioning Program to ensure both program areas are fully funded.
Accelerator, radiation-producing machines and vendors/service providers analysis
Through a staff of 71 located in the Department's central and regional offices, the RPP's Radiation Control Division administers the radiation-producing machine registration and inspection program, the Mammography Quality Standards Act Program, the particle accelerator licensing and inspection program and the vendor/service provider registration program.
The Radiation Control Division is responsible for the registration and inspection of over 11,000 facilities possessing about 33,000 X-ray units. These facilities include hospitals, clinics and medical and dental offices. Users of radiation-producing machines are required to register with the Radiation Control Division, indicate the number and type of units possessed and designate an individual responsible for radiation safety. Users pay registration fees based on the type of facility and the number of X-ray units they have. The fee amounts are listed in § 218.11(a).
Section 354 of the Federal Mammography Quality Standards Act (MQSA) (42 U.S.C. § 263b) was signed into law on October 27, 1992. The MQSA ensures that women and men receive high-quality mammography services for early breast cancer detection through the establishment of a Federal certification and inspection program. The statute authorizes the United States Food and Drug Administration (USFDA) to obtain state and local assistance in enforcing the MQSA requirements, including annual inspections of all certified mammography facilities. The Department, under a $588,000 reimbursement contract with the USFDA, conducts inspections of each of this Commonwealth's more than 300 facilities which perform mammographic X-ray procedures. This contract is modified most years due to the changing number of facilities. The average amount is $575,000.
The Department requires licensing of all particle accelerators within this Commonwealth for industrial use, research or medical purposes. A person who intends to purchase, construct or acquire an accelerator shall notify the Department of this intent by filing the appropriate application for a specific license within 30 days after the initial order is issued to obtain any or all parts of the accelerator. Annual fees for licensed particle accelerators are listed in § 218.11(d). About 150 facilities have approximately 250 licensed accelerators within this Commonwealth.
The Department also administers a registration program for vendors/service providers who sell, lease, install or service, or both, radiation-producing machines. Department regulations require that each vendor/service provider doing business within this Commonwealth must be registered prior to providing these services. To register, each vendor/service provider must complete a registration application and return that application with the associated fee to the Bureau of Radiation Protection. The registration is renewable for 12-month periods following submission of the applicable fee as listed in § 218.11(k).
In analyzing the annual costs and revenue associated with the Accelerator, Radiation-Producing Machines, and Vendors/Service Providers RPP fee category, the Department found that despite substantial increases in personnel and program costs, the Chapter 218 fees, which support the registration of radiation-producing machines and vendors/service providers and the licensing of accelerators, have not been revised since 2009. As a result, the Radiation Protection Fund is decreasing annually in operating reserves, and the fund balance will be negative in Fiscal Year (FY) 2023-2024. Without the fee increase in this final-form rulemaking, the Department would be required to curtail spending for needed equipment, infrastructure upgrades, and training and hiring of qualified personnel.
Radioactive materials and decommissioning analysis
The RPP's Radiation Control Division is also responsible for the regulation, licensing and inspection of radioactive material user operations and, along with the Decommissioning Section of the Decommissioning and Surveillance Division, is responsible for termination of radioactive material licenses (such as for by-product, source and special nuclear material).
Users of all by-product, source and special nuclear material are required to obtain a license from the Department prior to obtaining those radioactive materials. This material is used in hospitals, colleges and industries for medical, research and industrial purposes. The Department issues specific, general and reciprocity licenses for the use of radioactive material in this Commonwealth. The objective of the licensing program is to ensure radioactive material is used safely, disposed of properly and facilities are free from contamination when licensed operations are terminated. Annual license fees for radioactive material are listed in Chapter 218, Appendix A (relating to fees for radioactive material licenses).
The Decommissioning Section performs technical reviews of decontamination and decommissioning (D&D) activities for radioactive materials licensees and non-licensed radiologically contaminated sites in accordance with appropriate Commonwealth regulations. Typical reviews include site characterization plans, health and safety plans, decommissioning plans, survey reports, and the evaluation of decommissioning funding plans and financial assurance mechanisms. The Decommissioning Section also performs onsite reviews and inspections of D&D activities for occupational, public and environmental radiation protection concerns. These activities include performing confirmatory surveys and sampling to ensure the cleanup levels established for the site have been met. The Decommissioning Section would also perform independent oversight and sampling at decommissioning nuclear power plant sites (for example, Three Mile Island Unit 2). This work is performed at full cost recovery.
Fee collections for radioactive material licensing have been trending down since the National economic recession of 2008. Universities and industries that use radioactive material have been consolidating or finding other operational methods that do not require a license. Many licensees have opted to be licensed under a small business fee category at a lower cost, which is specified in Chapter 218, Appendix A. During this same time, actual RPP personnel costs (salaries and benefits) have increased approximately 14% since the last fee increase for this fee area took effect in 2017.
The Department's fiscal analysis showed that with existing reserve funds and current fees, the fund balance will be negative in FY 2024-2025 for the Radioactive Materials and Decommissioning area.
Summary of RPP funding needs
Based on the findings of the Report, this final-form rulemaking is necessary to address the discrepancy between anticipated fees and needed revenue for the Accelerator, Radiation-Producing Machines, and Vendors/Service Providers program area and the Radioactive Materials and Decommissioning program area.
In March 2008, then-Governor Edward Rendell signed an agreement with the Chairperson of the United States Nuclear Regulatory Commission (NRC) for the Commonwealth to become an Agreement State. This allows the Department to oversee and regulate licensure of radioactive materials for entities in this Commonwealth. These duties are funded through the Chapter 218 fees. As part of the agreement, the Commonwealth committed to implementing a radiation protection program comparable to the NRC's program and ensured that Department regulations would be compatible with NRC regulations.
The amendments to the Chapter 218 fees for radiation-producing machines, vendors and accelerators are necessary to ensure adequate funding is available for the Commonwealth to carry out its duties under the RPA. The amendments to the Chapter 218 fees for radioactive material licenses are necessary to ensure adequate funding is available for the Commonwealth to carry out its duties under the NRC's Agreement State program. If the Commonwealth were forced to cede its authority to regulate radioactive materials back to the NRC, the regulated community would experience higher costs per NRC's fee regulations.
To ensure there is adequate funding for these program areas and for the Commonwealth to maintain its status as an NRC Agreement State, the Board is increasing the fees associated with the Accelerator, Radiation-Producing Machines, and Vendors/Service Providers program area by 30% to provide sufficient revenue through FY 2027-2028 and the fees associated with the Radioactive Materials and Decommissioning program area by 10%, except for the full cost recovery hourly rate that is increased by 22% to $275, to ensure sufficient funding through FY 2027-2028.
Outreach
The amendments to the Chapter 218 fees for radiation-producing machines, vendors, and accelerators and for radioactive materials and decommissioning were reviewed with the Department's Radiation Protection Advisory Committee (RPAC). RPAC represents various stakeholders, including radiation-producing machine registrants, radioactive materials licensees and radon service providers, as well as the general public. The Department discussed the need for fee revisions and presented the draft proposed amendments to Chapter 218 to RPAC on March 3, 2022, and RPAC endorsed moving forward with the proposed rulemaking. The Department presented the draft final amendments to Chapter 218 to RPAC on December 9, 2022, and RPAC again endorsed moving forward with this final-form rulemaking.
E. Summary of Final-Form Rulemaking and Changes from Proposed to Final-Form Rulemaking
§ 218.11. Registration, renewal of registration and license fees
In subsection (a), the annual administrative fees and annual fees per X-ray tube or radiation generating device for radiation-producing machines are increased by approximately 30% to provide adequate funding to support the oversight of X-ray machines in hospitals, dental offices, veterinary clinics and other facilities. Additionally, ''Chiropractors'' have been moved out of the ''Other'' fee category and are now added to ''Chiropractors, dentists, podiatrists, veterinarians.'' This change was made because chiropractors' equipment is comparable with the equipment used by dentists, podiatrists and veterinarians.
In subsection (d)(1), the fee amounts for accelerators, below 50 MeV, other than for ion implantation are increased by 30% from $2,100 to $2,730 for the first accelerator at a facility and from $700 to $910 for each additional unit at the facility.
In subsection (d)(2), the fee amounts for accelerators used for ion implantation are increased from $700 to $910 and from $70 to $90 for each additional unit at the same facility.
In subsection (d)(3), the fee amounts associated with accelerators 50 MeV and above are increased by 30%. This includes the hourly rate considered for staff time to review license applications and to conduct inspections being increased from $150 per hour to $195 per hour; the minimum annual fee being increased from $2,100 to $2,730 for the first accelerator at a facility; and the fee for each additional unit being increased from $700 to $910.
In subsection (i), the annual fee amounts for electronic brachytherapy devices are increased by 30% from $1,000 to $1,300 for the first unit at a facility and from $100 to $130 for each additional unit at the facility.
In subsection (k), the annual registration fee for radiation-producing machine service providers is increased by 30% from $140 to $180.
There is no change made to this section from the proposed rulemaking to this final-form rulemaking.
Chapter 218, Appendix A. Fees for radioactive material licenses
The Board proposed to increase the 39 different fee categories for radioactive material licenses by 10% based on the findings of the Report to ensure adequate funding is available for the Commonwealth to carry out its duties under the Agreement State program. In this final-form rulemaking 38 different fee categories for radioactive material licenses are increased by 10%. One fee category, Category 6A—Nuclear Laundry, is being kept at the current rate of $43,200 in this final-form rulemaking and is not increased to $47,520 as originally proposed. There is currently one licensee in this category, who submitted comments on the proposed rulemaking requesting this fee be decreased based on the licensee's comparison of the Commonwealth's fee to the fees charged by other states where the licensee operates. However, these comparison states have other funding streams to help cover their program costs, while the Commonwealth's program is required by statute to be funded solely through the license, registration and certification fees.
Decreasing the fee is not feasible. Regulatory oversight for this license category is different from other categories and requires more Department resources, such as specialized training, more frequent sampling and increased financial assurance. However, the Board has determined that keeping this license category at the current rate for this 3-year fee review cycle is not expected to be detrimental to the RPP at this time, as currently there is only one nuclear laundry license in the Commonwealth. During the next 3-year fee review cycle, the Department will compile more detailed information and understanding of the complexities and uniqueness of this license category, which will allow the Board to assess if an additional adjustment to the nuclear laundry license fee category is appropriate.
Additionally, the full cost recovery fee, identified by the asterisk in this final-form rulemaking, is increased by 22% from $225 per hour to $275 per hour, which is below the NRC's current FY 2022 hourly rate of $290 per hour. This hourly rate is applicable to fee categories 4A (Waste Storage, Processing or Disposal), 5B (Well Logging Field Flood Tracer Studies) and 14 (Decontamination, Decommissioning, Reclamation or Site Restoration). The fee increase is needed to compensate for the increase in Department staff salaries, which have risen more than 22% since the last fee increase in 2017, as well as increases in the costs for infrastructure to support the radiation protection program staff. There was only one change made to this fee section from the proposed rulemaking to this final-form rulemaking to keep the Category 6A—Nuclear Laundry fee at the current rate.
F. Summary of Comments and Responses on the Proposed Rulemaking
The Independent Regulatory Review Commission (IRRC) and a commentator questioned whether the nuclear laundry license fee should be increased. The commentator submitted a comparison of nuclear laundry fees they pay in other states for this license category to explain why they feel an increase is not reasonable for this category. IRRC also asked the Board to explain why this fee and the proposed increase are reasonable and how they comply with the requirement in the RPA.
As noted in the previous section, the Board has declined to make the proposed change to the nuclear laundry fee in this final-form rulemaking and will keep the fee at its current rate. The Board will use the next 3-year fee review cycle to conduct further analysis. A nuclear laundry license is a complex license involving numerous requirements in addition to the inspection, license amendment and review of reports mentioned by the commentator. As discussed in more detail as follows, there are environmental monitoring requirements, financial assurance requirements and special training for RPP staff to review the licenses and perform the monitoring. In addition, there are infrastructure costs that must be maintained independent of the number of operational licenses.
Under license condition, a nuclear laundry is required to perform annual routine monitoring of the environment near and downstream of their wastewater discharge pipe into the river. This monitoring includes sampling of sediment (3 times per year), plant (2 times per year), fish (2 times per year) and clams (1 time per year) to monitor the radiological contaminants that they are discharging to the environment. The radiological results of this sampling must be reviewed by staff with Federally required, specialized training on radiological contaminants in the environment. Annual data is then compiled in a final report and evaluated against public dose limits. That report is also reviewed by this specially trained staff to evaluate their compliance.
Additionally, the RPP periodically collects or obtains split samples from the licensee to perform its own independent analysis. This sampling requires specific equipment to collect and submit samples. Each sample has a cost for radiological analysis.
By Federal regulation at 10 CFR 30.35 (relating to financial assurance and recordkeeping for decommissioning) incorporated by reference in § 217.131 (relating to incorporation by reference), a nuclear laundry is required to maintain financial assurance to ensure funds are available should the licensee become unable to properly maintain the site prior to termination of its license. This financial assurance requires a cost-specific review of what it would take for a third party to come in and properly clean up the facility and the surrounding environment, both surface and subsurface. This cost estimation is required to be submitted at least every 3 years. The cost estimate and associated financial assurance mechanisms require detailed review and approvals and require special training for the individuals who perform those reviews.
At a minimum, the reviews mentioned previously require at least one technical staff and one manager to complete the review for each submission. The financial assurance reviews typically involve at least one additional staff member to make sure the review is thorough. Therefore, two or three RPP staff's time is required for each of these compliance activities.
The RPP maintains a section of staff specifically trained for decommissioning and environmental monitoring. The NRC Agreement State Program requires that this staff receives specialized training to be qualified to implement these decommissioning and environmental monitoring requirements. Currently, the commentator's nuclear laundry facility is the sole license in this Commonwealth requiring environmental monitoring—not just the only license in the nuclear laundry license category but the only license out of all radioactive material license categories. Therefore, the commentator's nuclear laundry facility license fee is the only funding source to support this specialized training.
There is a cost for the infrastructure that must be maintained independent of the number of operational licenses. These infrastructure costs include indirect and administrative services, including rulemaking, maintaining guidance for licensees and maintaining procedures for staff, training and travel, the cost of information management, information technology, security, facilities management, rent, utilities, financial management, acquisitions, human resources and policy support.
The commentator has compared the Commonwealth's license fees with states that are able to supplement their fees with other funds to administer their programs. Section 401 of the RPA states that ''. . .[t]hese fees shall be in an amount at least sufficient to cover the department's costs of administering the programs.'' Consequently, the Commonwealth's RPP is funded entirely through its license, registration and certification fees.
As noted in the funding Report for the RPP and in the preamble to the proposed rulemaking, the Radiation Protection Fund balance will go into the negative in FY 2023-2024. Therefore, the Department cannot afford a delay in promulgating this final-form rulemaking and decreasing the fee is not feasible. However, the Board has determined that keeping this license category at the current rate for this 3-year fee review cycle is not expected to be detrimental to the RPP at this time, as currently there is only one nuclear laundry license in the Commonwealth. During the next 3-year fee review cycle, the Department will compile more detailed information on this unique license category, including but not limited to, training, sampling and staff hours, which will allow the Board to assess if an additional adjustment to the nuclear laundry license fee category is appropriate.
IRRC noted the full cost recovery fee for licenses in categories 4A, 5B and 14 was proposed to be increased by 22% but the Preamble and Regulatory Analysis Form (RAF) stated the fees in Chapter 218, Appendix A are increased by 10% and requested the documents be revised. IRRC also asked the Board to explain why the increase was needed and reasonable. As IRRC noted, the full cost recovery fee is an hourly rate charged for D&D activities performed by Department staff. This fee is rarely utilized because it only applies in two situations. One is the extraordinary circumstance that a non-licensee possesses radioactive material requiring D&D and therefore has not paid any license fee to the Department. The other case is when a licensee requests termination of their operating license and conversion to a decommis- sioning-only license. In this case, the Department would only charge the hourly rate if Program staff had completed enough work to exceed the annual fee paid by the licensee. This allows the Department to recover the full cost of staff time spent on unplanned work that is not included in the Program's revenue projections. In addition to covering personnel salaries, there is a cost for the infrastructure that must be maintained independent of the number of operational licenses, which was discussed in detail previously in this section of the preamble. As this is an hourly professional rate for a license category with an unpredictable number of licensees, the fee increase is needed to compensate for the increase in Department staff salaries and infrastructure costs, which have risen more than 22% since the last fee increase in 2017. The preamble and RAF for this final-form rulemaking have been updated to provide an explanation for the fee increase and the correct percentage increase of 22%.
IRRC noted the estimates of costs to local governments and State government in questions 20 and 21 of the RAF conflict with estimates given for question 23. The responses to questions 20 and 21 are correct, and the response to question 23 has been revised accordingly.
G. Benefits, Costs and Compliance
Benefits
The Chapter 218 fee increases for radioactive material licenses are necessary to ensure that adequate funding is available for the Commonwealth to carry out its duties under the Agreement State program and the RPA. If the Commonwealth were forced to cede its authority to regulate radioactive materials back to the NRC, the regulated community would be subject to higher NRC fees. Radioactive material controls under the Agreement State program guard against the potential for unnecessary public radiation exposure from the use of radioactive material benefitting the health of all residents in this Commonwealth.
The Chapter 218 fees for registration of X-ray facilities, licensing of accelerators and registration of vendors have not been increased since 2009, although costs have steadily increased. These fee increases are necessary to ensure oversight of radiation safety-related activities are not diminished and the replacement of obsolete survey equipment is not delayed, which would reduce the assurance that regulated activities are being conducted safely.
For these reasons, the Department benefits from this final-form rulemaking by having the needed additional revenue to cover the costs of the programs mandated by the RPA, and the general public will benefit from this final-form rulemaking by the continued safety with the use of radioactive materials, the safety of radiation-producing machines and additional quality assurance that will be provided.
Compliance costs
The cost of compliance with the fee amendments for the Accelerator, Radiation-Producing Machines, and Vendors/Service Providers program area are increased by 30% to provide sufficient revenue through FY 2027-2028. The cost of compliance with the fee amendments for the Radioactive Materials and Decommissioning program area are increased by 10% for licensing and 22% for the full cost recovery fee to ensure sufficient funding through FY 2027-2028. Considering increases in inflation since the last time these fee categories were increased (2009 for the Accelerator, Radiation-Producing Machines, and Vendors/Service Providers program area and 2017 for the Radioactive Materials and Decommissioning program area), the cost of compliance is increased in line with inflation rates.
Compliance assistance plan
The Department will notify the regulated community of the increased fees by informing RPAC, issuing an Information Notice to relevant licensees and publishing notification in the Pennsylvania Bulletin.
Paperwork requirements
This final-form rulemaking does not require additional recordkeeping or reporting requirements as a result of the fee increases in Chapter 218.
H. Pollution Prevention
The Federal Pollution Prevention Act of 1990 (42 U.S.C. §§ 13101—13109) established a National policy that promotes pollution prevention as the preferred means for achieving state environmental protection goals. The Department encourages pollution prevention, which is the reduction or elimination of pollution at its source, through the substitution of environmentally friendly materials, more efficient use of raw materials or the incorporation of energy efficiency strategies. Pollution prevention practices can provide greater environmental protection with greater efficiency because they can result in significant cost savings to facilities that permanently achieve or move beyond compliance.
This final-form rulemaking is designed to support the safe and effective use of licensed radioactive materials and radiation-producing machines to protect the health and safety of residents, workers and the environment in this Commonwealth. By increasing fees to keep the Radiation Protection Fund solvent in the coming years, this final-form rulemaking ensures the Department's ability to implement radiological pollution prevention.
I. Sunset Review
The Board is not establishing a sunset date for this final-form rulemaking because it is needed for the Department to carry out its statutory authority. The Department will continue to closely monitor these regulations for their effectiveness and recommend updates to the Board as necessary.
J. Regulatory Review
Under section 5(a) of the Regulatory Review Act (RRA) (71 P.S. § 745.5(a)), on August 10, 2022, the Department submitted a copy of the notice of proposed rulemaking, published at 52 Pa.B. 5500 (August 27, 2022), and a copy of an RAF to IRRC and the Chairpersons of the House and Senate Environmental Resources and Energy Committees for review and comment.
Under section 5(c) of the RRA, IRRC and the Committees were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing this final-form rulemaking, the Department has considered all comments from IRRC, the House and Senate Committees and the public.
Under section 5.1(j.2) of the RRA (71 P.S. § 745.5a(j.2)), on May 17, 2023, this final-form rulemaking was deemed approved by the House and Senate Committees. Under section 5.1(e) of the RRA, IRRC met on May 18, 2023, and approved this final-form rulemaking.
K. Findings of the Board
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P.L. 769, No. 240) (45 P.S. §§ 1201 and 1202), referred to as the Commonwealth Documents Law, and regulations promulgated thereunder at 1 Pa. Code §§ 7.1 and 7.2 (relating to notice of proposed rulemaking required; and adoption of regulations).
(2) A public comment period was provided as required by law, and all comments were considered.
(3) This final-form rulemaking does not enlarge the purpose of the proposed rulemaking published at 52 Pa.B. 5500.
(4) These regulations are necessary and appropriate for administration and enforcement of the authorizing acts identified in section C of this order.
L. Order of the Board
The Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 25 Pa. Code Chapter 218, are amended by amending § 218.11 and Chapter 218, Appendix A to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Chairperson of the Board shall submit this final-form rulemaking 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 final-form rulemaking 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 final-form rulemaking and deposit it with the Legislative Reference Bureau, as required by law.
(e) This final-form rulemaking shall take effect 30 days after publication in the Pennsylvania Bulletin.
RICHARD NEGRIN,
Acting Chairperson(Editor's Note: See 53 Pa.B. 3055 (June 3, 2023) for IRRC's approval order.)
Fiscal Note: Fiscal Note 7-574 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 25. ENVIRONMENTAL PROTECTION
PART I. DEPARTMENT OF ENVIRONMENTAL PROTECTION
Subpart D. ENVIRONMENTAL HEALTH AND SAFETY
ARTICLE V. RADIOLOGICAL HEALTH
CHAPTER 218. FEES
PAYMENT OF FEES § 218.11. Registration, renewal of registration and license fees.
(a) Annual registration fees for radiation-producing machines are the sum of an annual administrative fee and an annual fee for each X-ray tube or radiation generating device and shall be paid as follows:
Type Facility Annual Administrative Fee Annual Fee per X-ray Tube or Radiation Generating Device Chiropractors, dentists, podiatrists, veterinarians $130 $65 Hospitals $940 $65 Other Facilities $455 $65
* * * * * (d) Particle accelerators are licensed under Chapter 228 (relating to radiation safety requirements for particle accelerators). Annual fees are as follows:
(1) Accelerators, below 50 MeV, other than for ion implantation—$2,730 for the first accelerator at the facility plus $910 for each additional unit at that facility.
(2) Accelerators used for ion implantation—$910 plus $90 for each additional unit at the same facility.
(3) Accelerators 50 MeV and above—full cost of staff time to review license applications and conduct inspections as needed. (Hourly rate is $195 per hour). For the purpose of anticipating costs and compliance with subsections (e) and (f), a minimum annual fee of $2,730 for the first accelerator at the facility plus $910 for each additional unit is established. Additional invoices will be issued by the Department at regular intervals at least quarterly when net costs are incurred above the minimum annual fee.
* * * * * (i) Electronic brachytherapy devices are licensed under Chapter 221 (relating to X-rays in the healing arts). The annual fee is $1,300 for the first unit (controller) at the facility plus $130 for each additional unit at that facility.
(j) Emerging technology devices require Department safety review and approval prior to use. The registrant shall pay a fee equal to the full cost of Department staff time, as specified in Appendix A, for the review and approval process.
(k) A radiation-producing machine service provider shall pay an annual registration fee of $180.
(l) The Department will review the adequacy of the fees established in this section at least once every 3 years and provide a written report to the EQB. The report must identify any disparity between the amount of program income generated by the fees and the costs to administer these programs, and must contain recommendations to increase fees to eliminate the disparity, including recommendations for regulatory amendments to increase program fees.
APPENDIX A
Fees for Radioactive Material Licenses
Fee Category5,6 Description Annual
Fee ($)1,2,3,4,71C Special Nuclear Material Sealed Source Gauges (X-Ray Fluorescence) 3,465 1D Special Nuclear Material—Other 9,570 2A(2)(c) Source Material—Metal Extraction 49,610 2A5 Removal of Radioactive Contaminants from Drinking Water 18,480 2B Source Material as Shielding 1,240 2C Source Material—Other (not 11e2) 22,110 3A Manufacturing & Distribution Commercial Broad Scope—10 CFR 30, 33 48,015 3B Manufacturing, Refurbishing & Distribution Commercial Specific License—10 CFR 30 13,695 3C Manufacturing & Distribution Pharmaceuticals—10 CFR 32.72—32.74 19,635 3D Pharmaceuticals—Distribution Only—10 CFR 32.7x 11,220 3E Irradiator—Shielded Source 6,930 3F Irradiator—Unshielded < 10kCi 12,870 3G Irradiator—Unshielded >= 10kCi 51,480 3I Distribution As Exempt—No Review of Device 17,655 3J Distribution—SSD Devices to Part 31 GLs 4,125 3K Distribution—No Review-Exempt Sealed Source 3,135 3L Research & Development Broad Scope 24,915 3M Research & Development 9,240 3N Services other than Leak Testing, Waste Disposal or Calibration 14,025 3O Radiography 23,265 3P Other Byproduct Material 4,455 3Q Generally licensed devices under § 217.143 (relating to certain measuring, gauging or controlling devices) 530 3R1 Greater than the General License Limits in 10 CFR 31.12(a)(3), (4) or (5) but not more than ten times those Limits 3,465 3R2 Greater than ten times the General License Limits in 10 CFR 31.12(a)(3), (4) or (5) 4,455 3S Manufacturing & Distribution Pharmaceuticals—Accelerator Produced Only 19,470 4A Waste Storage, Processing or Disposal Full Cost *
4B Waste Packaging or Repackaging 19,800 4C Waste Receipt of Prepackaged for Disposal 15,180 5A Well Logging & Non Field Flood Tracers 7,260 5B Well Logging Field Flood Tracer Studies Full Cost *
6A Nuclear Laundry 43,200 7A Human Use—Teletherapy 22,605 7B Human Use—Broad Scope (except Teletherapy) 39,875 7C Human Use (except Teletherapy) 8,085 8A Specifically licensed sources used in static eliminators, nonexempt smoke detectors, fixed gauges, dew pointers, calibration sources, civil defense uses or in temporary (2 years or less) storage 3,465 14 Decontamination, Decommissioning, Reclamation or Site Restoration Full Cost * 16 Reciprocity (180 days/year) 2,475 SB15 Small Business—Category 1 3,795 SB26 Small Business—Category 2 825 1 A license may include as many as four noncontiguous sites at the base fee. Sites that are within 5 miles of the main radiation safety office where the license records are kept will be considered contiguous. An additional fee of 25% of the base fee will be added for each noncontiguous site above four.
2 All fees will be effective upon publication of the final rules in the Pennsylvania Bulletin. Existing NARM licenses will be changed to the corresponding category of byproduct material license in Appendix A upon publication of the final rule.
3 Annual fees for categories of NRC licenses that are not included in this table will be calculated as follows: PA Fee = (NRC Annual Fee + 0.10 NRC Application or Renewal fee).
4 Annual fees charged to holders of transferred NRC licenses with multiple sites will not exceed the fees charged by the NRC for the same licenses that are in effect in the year of transfer, provided the number of noncontiguous sites does not increase.
5 Small Businesses Not Engaged in Manufacturing, and Small Not-For-Profit Organizations with Gross Annual Receipts of more than $350,000 and less than $5 million; Manufacturing Entities that have an average of 35—500 employees with Gross Annual Receipts of more than $350,000 and less than $5 million; Small Government Jurisdictions (including publicly supported, nonmedical educational institutions) with a population between 20,000 and 50,000; and nonmedical Educational Institutions that are not State or publicly supported and have 35—500 employees.
6 Small Businesses Not Engaged in Manufacturing, and Small Not-For-Profit Organizations with Gross Annual Receipts of less than $350,000; Manufacturing Entities that have an average of less than 35 employees and less than $350,000 in Gross Annual Receipts; Small Government Jurisdictions (including publicly supported nonmedical educational institutions) with a population less than 20,000; and nonmedical Educational Institutions that are not State or publicly supported and have less than 35 employees.
7 Full cost recovery licensees and licensees required to provide financial assurance for decommissioning are not eligible for reduced fees under category SB1 or SB2.
*Full cost recovery consists of a professional fee, to cover the activities and support of Department personnel, and any other additional incidental charges incurred, such as related contracted services or laboratory costs. The professional fee component (Hourly Rate) is $275 per hour. Other costs are recovered at 100% of actual cost. Invoices shall be issued by the Department at regular intervals but at least quarterly when net costs are incurred.
[Pa.B. Doc. No. 23-815. Filed for public inspection June 23, 2023, 9:00 a.m.]
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