Title of Regulation: 12VAC5-490. Virginia Radiation Protection Regulations: Fee Schedule (amending 12VAC5-490-10, 12VAC5-490-20).

Statutory Authority: § 32.1-229.1 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: November 18, 2016.

Agency Contact: Steve Harrison, Director, Division of Radiological Health, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-8151, FAX (804) 864-8155, or email steve.harrison@vdh.virginia.gov.

Basis: Section 32.1-229.1 of the Code of Virginia authorizes the State Board of Health to set fees for x-ray equipment and requires the State Board of Health to promulgate regulations for the registration, inspection, and certification of x-ray machines by Department of Health personnel (except for audit inspections initiated by the department). Section 32.1-229.2 of the Code of Virginia requires the State Board of Health to set inspection fees to minimize competition with the private sector and include all reasonable costs.

Purpose: The proposed regulatory action addresses two sets of fees levied by the x-ray machine program: x-ray machine registration fees and x-ray machine inspection fees.

Radiological control program regulations currently require the registration of nonmedical x-ray equipment (i.e., baggage, cabinet or analytical, and industrial equipment) but do not establish a fee for registration of this equipment, do not establish a fee for the Office of Radiological Health (ORH) to inspect this equipment, and do not specify associated inspection frequencies. Registration and inspection fees for x-ray equipment not used in the healing arts are charged in other states.

The harmful effects of radiation are well known, as well as the many beneficial applications of radiation in industry and health care. Adequate regulatory controls for the useful application of radiation are necessary to protect the health, safety, and welfare of citizens. The potential exists for accidents associated with this equipment, which have in fact occurred. Accordingly, regulatory attention needs to be applied to promote the safety of nonmedical x-ray equipment. These fees will help offset the cost of administrative activities involved in the registration, inspection, and certification of nonmedical x-ray equipment. These costs were once absorbed from general funds allocated to ORH, but those general funds have since been abolished.

Substance: In 12VAC5-490-10, the fee for each machine and additional tubes that has an inspection frequency of every three years is proposed to increase from $50 to $60, collected every three years.

The following annual registration fees are proposed for all operators or owners of baggage, cabinet or analytical, or industrial x-ray machines capable of producing radiation:

• $20 for each machine used for baggage inspection;

• $25 for each machine identified as cabinet or analytical; and

• $50 for each machine used for industrial radiography.

The amendments to 12VAC5-490-20 add the following inspection fees and required inspection frequencies for operators or owners of baggage, cabinet or analytical, or industrial x-ray machines capable of producing radiation:

• Baggage x-ray unit: $100 per inspection, inspected every five years;

• Cabinet/analytical x-ray unit: $150 per inspection, inspected every three years; and

• Industrial radiography x-ray unit: $200 per inspection, inspected annually.

Issues: The primary advantage of this change to the public and the regulated community is that registering all x-ray machines allows ORH to maintain an accurate database of the devices, track inspections, and ensure that the machines are functioning properly so as to minimize the risk of equipment malfunction and accidental overexposures.

The primary advantage to the public is that the x-ray machine registration and inspection fees rely on owners or operators of the x-ray equipment. There are no disadvantages to the public in promulgating the proposed fee schedule.

The advantage to the agency and Commonwealth is that approving the proposed fee structure will allow the Commonwealth to recover more of the costs associated with carrying out the legislative mandate. There are no disadvantages to the agency and Commonwealth in promulgating the proposed fee schedule. The other pertinent matter of interest to the regulated community is that x-ray machine registrants have an interest in keeping inspection fees as low as possible.

Private inspectors of x-ray machines have an interest in ensuring that inspection fees by agency inspectors do not hurt their businesses by undercutting the private sector pricing, and § 32.1-229.2 of the Code of Virginia requires the agency to establish inspection fees in such a manner so as to minimize competition with the private inspector while recovering costs.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to amend the registration fee for x-ray machines inspected every three years and add three new fee categories for the annual registration and periodic inspection of non-medical x-ray devices.

Result of Analysis. Benefits likely outweigh costs for these proposed changes.

Estimated Economic Impact. Current regulation requires owners of medical use x-ray machines and tubes that need to be inspected every three years to pay a registration fee of $50 every three years. The Board proposes to raise this fee to $60 every three years because costs for administering this program have increased. This change will minimally increase costs for owners of such machines (by about $3 per year per machine and tube) but the costs of this change are likely outweighed by the benefits of periodically ensuring that x-ray machines are in safe working order.

Although all owners of x-ray machines that are located in the Commonwealth, and are not under the auspices of the federal government,¹ are required to register such machines with the Virginia Department of Health (VDH), currently only owners of medical use x-ray machines are required to pay a registration fee and an inspection fee (if VDH is the entity that completes the inspection). The Board proposes to add three categories of registration and inspection fees for VDH inspections that will apply to owners of non-medical use x-ray machines. The Board proposes to require an annual registration fee of $20 for each x-ray machine used for baggage inspection, $25 for each x-ray machine that is identified as cabinet or analytical² and $50 for each x-ray machine used for industrial radiography³.

Additionally, the Board proposes to add inspection fees and required inspection intervals for non-medical x-ray machines. Baggage x-ray units will be required to be inspected every five years and will be subject to an inspection fee of $100 if they are inspected by VDH. Cabinet/analytical x-ray units will be required to be inspected every three years and will be subject to an inspection fee of $150 if they are inspected by VDH. Industrial radiography x-ray machines will be required to be inspected every year and will be subject to an inspection fee of $200 if they are inspected by VDH. Board staff reports that about 85% of medical x-ray machine inspections are completed by private businesses rather than VDH, that they expect that most inspections of non-medical x-ray machines will also be completed privately and that the Board does not have estimates of how private inspection fees will compare to those charged by VDH. However, Board staff also reports that fees for private inspection of medical use x-ray machines are generally higher than those charged by VDH for inspecting any given category of machine.

Owners of non-medical x-ray machines that are not local or state governments⁴ will newly incur annual registration costs on account of this proposal. Owners of non-medical x-ray machines will only newly incur costs for inspections to the extent that they were not already being inspected at intervals newly required by the Board. These costs are likely outweighed by the benefits of periodically ensuring that x-ray machines are in safe working order.

Businesses and Entities Affected. Board staff reports that this proposed regulation will affect all owners or medical use x-ray devices that require inspection every three years as well as all owners of non-medical x-ray machines. Board staff further reports that there are currently 630 non-medical facilities with 1,597 x-ray machines; of these, 190 facilities are state or local government entities, 110 are likely small businesses and the remaining 330 are private businesses that would not qualify as small businesses.

Localities Particularly Affected. No locality will be particularly affected by this regulatory change.

Projected Impact on Employment. This proposed regulatory change is unlikely to have any impact on employment in the Commonwealth.

Effects on the Use and Value of Private Property. This proposed regulation is unlikely to have any impact on the use or value of private property.

Real Estate Development Costs. This proposed regulation is unlikely to affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. Affected non-medical small businesses will incur costs for annual registration, and period inspection, of any x-ray machines that they own. Affected medical small businesses will incur an additional $10 cost every three years for registration of each x-ray machine and additional tube that they own.

Alternative Method that Minimizes Adverse Impact. There are likely no alternative methods that would both satisfy the Board's aim of ensuring x-ray machine safety and further minimize costs.

Adverse Impacts:

Businesses. Affected non-medical businesses will incur costs for annual registration, and period inspection, of any x-ray machines that they own. Affected medical businesses will incur an additional $10 cost every three years for registration of each x-ray machine and additional tube that they own.

Localities. Affected localities will incur costs for required inspections only to the extent that they are not already inspecting these machines at the required intervals proposed in this regulation, but will not incur registration fees.

Other Entities. No other entities are likely to suffer any adverse impact on account of this proposed regulation.

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¹Airports are under federal auspices and are exempt from this regulation.

²Industries that engage in research and development would be one example of this.

³Industrial radiography is a method of inspecting materials for hidden flaws by using the ability of short X-rays and gamma rays to penetrate various materials. Two ways to inspect materials for flaws is to utilize X-ray computed tomography or industrial computed tomography scanning.

⁴State and local governments that have x-ray machines in places like schools, courthouses, jails and prisons are exempt from the Board's proposed registration fees but still must pay for periodic inspections of these machines.

Agency's Response to Economic Impact Analysis: The Virginia Department of Health, Office of Radiological Health concurs with the Virginia Department of Planning and Budget's economic impact analysis.

Summary:

The proposed amendments (i) raise the registration fee for x-ray machines and additional tubes inspected every three years; (ii) add three categories (baggage, cabinet or analytical, and industrial), associated fees, and frequency for the registration of nonmedical x-ray equipment; and (iii) add three categories (baggage, cabinet or analytical, and industrial) and associated fees for the inspection of nonmedical x-ray equipment.

12VAC5-490-10. Registration fees.

A. All operators or owners of diagnostic X-ray x-ray machines used in the healing arts and capable of producing radiation shall pay the following registration fee:

1. $50 for each machine and additional tube(s) that have a required annual inspection, collected annually; and

$50 2. $60 for each machine and additional tube(s) that have a required inspection every three years, collected every three years.

B. All operators or owners of therapeutic X-ray x-ray, particle accelerators, and teletherapy machines used in the healing arts capable of producing radiation shall pay the following annual registration fee:

1. $50 for each machine with a maximum beam energy of less than 500 KVp;

2. $50 for each machine with a maximum beam energy of 500 KVp or greater.

C. All operators or owners of baggage, cabinet or analytical, or industrial x-ray machines capable of producing radiation shall pay the following annual registration fee:

1. $20 for each machine used for baggage inspection;

2. $25 for each machine identified as cabinet or analytical; and

3. $50 for each machine used for industrial radiography.

D. Where the operator or owner of the aforementioned machines is a state agency or local government, that agency is exempt from the payment of the registration fee.

12VAC5-490-20. Inspection fees and inspection frequencies for x-ray machines.

The following table lists the fees that shall be charged for surveys requested by the registrant and performed by a Department of Health inspector, as well as the required inspection frequencies for each type of x-ray machine:

Type	Cost Per Tube	Inspection Frequency
General Radiographic (includes: Chiropractic and Special Purpose X-ray Systems)	$230	Annually
Fluoroscopic, C-arm Fluoroscopic	$230	Annually
Combination (General Purpose-Fluoroscopic)	$460	Annually
Dental Intraoral and Panographic	$90	Every 3 years
Veterinary	$160	Every 3 years
Podiatric	$90	Every 3 years
Cephalometric	$120	Every 3 years
Bone Densitometry	$90	Every 3 years
Combination (Dental Panographic and Cephalometric)	$210	Every 3 years
Shielding Review for Dental Facilities	$250	Initial/Prior to use
Shielding Review for Radiographic, Chiropractic, Veterinary, Fluoroscopic, or Podiatric Facilities	$450	Initial/Prior to use
Baggage X-ray Unit	$100	Every 5 years
Cabinet or Analytical X-ray Unit	$150	Every 3 years
Industrial Radiography X-ray Unit	$200	Annually