Title of Regulation: 12VAC5-490. Virginia Radiation Protection Regulations: Fee Schedule (adding 12VAC5-490-50).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: July 14, 2017.

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 annual registration fees for x-ray device private inspectors, not to exceed $150 for such registration. Upon approval of the application, the private inspector will be included on the Commonwealth's list of qualified x-ray machine inspectors published pursuant to § 32.1-228.1 of the Code of Virginia.

Purpose: The Virginia Department of Health, Office of Radiological Health (ORH) proposes to amend 12VAC5-490, Radiation Protection Fee Schedule, by establishing a new section, 12VAC5-490-50, Private inspector registration fees. Radiological Control Program regulations, which already require the registration of individuals who inspect x-ray producing devices in the Commonwealth, do not establish fees for their initial registration or annual renewal. Revenue recovery, as is the practice in other states using x-ray device private inspectors, will help offset administrative costs associated with document collection, review, and approval; the issuance of certificates; and the maintenance of an up-to-date private inspector directory. These fees will help offset such administrative costs that were once supported using general funds allocated to ORH but that have since been abolished.

The purpose of the Commonwealth's X-ray Program is to protect the public from unnecessary radiation due to faulty x-ray equipment or substandard practices, largely identified through inspections. Radiological Control Program regulations require the registration of private inspectors who inspect x-ray producing devices in the Commonwealth. The ORH is proposing fees for the recovery of costs associated with the verification of private inspector academic credentials and professional certifications. This single source verification of private inspector credentials can be considered similar to the licensure procedure for medical professionals and should be performed with no less diligence. These activities require significant attention and expense by ORH staff to confirm private inspector credentials so as to assure public health and worker safety since those individuals inspect and certify x-ray producing devices.

Substance: The proposed amendments establish fees for the registration and annual renewal of registration for individuals who inspect x-ray devices in the Commonwealth.

Issues: The primary advantage of this change to the public and the regulated community is that the establishment of private inspector fees will help offset administrative costs that were once paid using general funds but that have since been abolished. There are no disadvantages to the public in promulgating the proposed fee schedule. Approving the proposed fee structure will allow the Commonwealth to recover more of the costs associated with carrying out the legislative mandate, which will be the primary advantage to the agency and Commonwealth. There are no disadvantages to the agency and Commonwealth in promulgating the proposed fee schedule. Private inspectors of x-ray machines have an interest in ensuring that inspection fees by agency inspectors do not hurt their business 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.

Small Business Impact Review Report of Findings: This proposed regulatory action serves as the report of the findings of the regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.

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 its Virginia Radiation Protection Regulations: Fee Schedule regulation to set a registration fee for x-ray device private inspectors.

Result of Analysis. There is insufficient information to ascertain whether benefits will outweigh costs for this proposed regulation.

Estimated Economic Impact. Since 2008, x-ray device private inspectors have been required to meet the qualifications in 12VAC5-481-340¹ for registration with the Board but have not historically been charged a fee for that registration. Instead, the Board used its general fund appropriations to cover the cost of administering this registration program. In 2015, the General Assembly removed general fund support for this and other Board registration programs. In 2016, the General Assembly approved legislation that allows the Board to charge x-ray device private inspectors a fee not greater than $150 for annual registration.²

The Board now proposes to amend this regulation to require x-ray device private inspectors to pay an annual $150 registration fee. Board staff reports that this fee will cover the costs of staff time spent verifying registrants' education, training and occupational history as well as time spent two times per year maintaining and updating the list of registered inspectors. To the extent that requiring registration of x-ray device private inspectors provides the benefit of additional safety to the public, requiring the payment of fees to support that registration will provide the same benefit. Any benefits would need to be weighed against the additional $150 cost that these inspectors will incur each year to maintain registration.

Businesses and Entities Affected. These proposed regulatory changes will affect the 174 x-ray device private inspectors who are currently registered with the Board, as well as any x-ray device inspectors who may register in the future.

Localities Particularly Affected. No locality is likely to be particularly affected by these proposed regulatory changes.

Projected Impact on Employment. Increasing the cost of entering or remaining in a profession generally will decrease the number of individuals who choose to practice in that profession. Imposing a $150 fee on x-ray device private inspectors may slightly decrease the number of individuals who choose to be inspectors.

Effects on the Use and Value of Private Property. These proposed regulatory changes are unlikely to affect the use or value of private property in the Commonwealth.

Real Estate Development Costs. These proposed regulatory changes are unlikely to affect real estate development costs in the Commonwealth.

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. Board staff reports that all registered x-ray device private inspectors would qualify as small businesses. All of these businesses will incur additional annual costs of $150 per inspector on account of this proposed regulation.

Alternative Method that Minimizes Adverse Impact. There are likely no other available methods that would both meet the Board's goal of having this registration program be self-supporting and further minimize adverse impacts for registrants.

Adverse Impacts:

Businesses. Affected businesses will incur additional annual costs of $150 per inspector on account of this proposed regulation.

Localities. Localities in the Commonwealth are unlikely to see any adverse impacts on account of these proposed regulatory changes.

Other Entities. No other entities are likely to be adversely affected by these proposed changes.

__________________________________

¹ http://law.lis.virginia.gov/admincode/title12/agency5/chapter481/section340/

² http://lis.virginia.gov/cgi-bin/legp604.exe?161+ful+CHAP0685

Agency's Response to Economic Impact Analysis: All users of x-ray machines are required to register with the department prior to the operation of x-ray equipment in the Commonwealth. The application package for this registration can be found at http://www.vdh.virginia.gov/content/uploads/sites/7/2016/10/RH-F-27-PRIVATE-INSPECTOR-APPLICATION-Modified-09-17-2014.pdf.

Further, each registered facility is required to have an inspection performed prior to any operation of x-ray equipment after a new installation or machine relocation.

Individuals who have been qualified by the department in accordance with 12VAC5-481-340, Private inspector qualifications, can perform inspections instead of a department X-Ray Program inspector. Were it not for private inspectors, there could be a delay in the timeliness of inspections as there are only seven department inspectors employed by the Commonwealth, one of whom is the X-Ray Program supervisor. These seven inspectors can accommodate only about 20% of the inspection needs of the Commonwealth, leaving the remaining 80% to the private sector. However, the private inspectors must be qualified and certified to perform and submit the inspections, as described in the above referenced regulation, to ensure a positive safety benefit exists for the public.

It is important to note that medical x-rays cause the majority of the average person's exposure to human-made radiation. The National Academies National Research Council has reported that even low doses of ionizing radiation, such as x-rays, are likely to pose some risk of adverse health effects. State registration and inspection of x-ray equipment is necessary to minimize radiation exposure to the public. The goal and objective of the x-ray program is to ensure that users of x-ray equipment have an effective radiation safety program that reduces the likelihood that individuals receive unnecessary radiation exposure. Effective controls involve the verification of the following by a qualified, certified inspector:

• The x-ray unit performs as designed. This is needed to maintain high quality images and reduce the repeat of x-ray procedures. The result is adequate diagnostic information for appropriate patient care, while minimizing radiation exposure to the patient.

• The training, education, and licensing of x-ray equipment operators are evaluated.

• Surveys of radiation levels in and around the x-ray suite are performed to ensure that regulatory limits are not exceeded. Information is collected to evaluate the potential radiation dose to radiation workers (employees) and the public.

• Radiation dose to patients is evaluated so that medical practitioners can provide patients with information about the dose from an x-ray procedure. Comparing this information between facilities can help practitioners and patients evaluate the risk and benefits of an x-ray procedure.

• Radiation safety procedures concerning a pregnant patient, a pregnant radiation worker, shielding of the patient or staff, and holding or assisting patients can be evaluated.

• Onsite evaluations can help x-ray administrators determine if the cause of poor quality images is due to the performance of the x-ray equipment.

Summary:

The proposed amendments establish fees for the initial registration and subsequent annual renewal of registration for individuals who inspect x-ray devices in the Commonwealth.

12VAC5-490-50. Private inspector registration fees.

A. Individuals included on the Commonwealth's list of qualified inspectors of x-ray machines pursuant to § 32.1-229.1 D 5 of the Code of Virginia as of November 1, 2016, shall pay annually a registration renewal fee of $150 to the Virginia Department of Health X-Ray Program to remain on the list as a qualified inspector of x-ray machines pursuant to 12VAC5-481-340.

B. Individuals requesting to be placed on the Commonwealth's list of qualified inspectors of x-ray machines pursuant to § 32.1-229.1 D 5 of the Code of Virginia shall:

1. Request approval by the Office of Radiological Health to become a qualified inspector of x-ray machines pursuant to 12VAC5-481-340;

2. Pay an initial registration fee of $150 to the Virginia Department of Health X-Ray Program, once approved; and

3. Pursuant to subsection A of this section, pay annually a registration renewal fee of $150 to remain on the list as a qualified inspector of x-ray machines pursuant to 12VAC5-481-340.

FORMS (12VAC5-490)

Application to be Listed as a Private Inspector of X-ray Machines, RH-F-27 (eff. 9/2014)