Office of Radiological Health (ORM) issued several exemptions from various sections of 12VAC5-481 that are not specifically mentioned in the Agency Background Document. The agency has since taken down the website that listed these exemptions. There were several related to the qualifications of the Private Inspector. There was one in particular that I found objectionable. The exemption issued for 12VAC5-481-340 contained an additional condition for the qualifications for the Private Inspector providing services in mammography consisting or an “or” statement that allowed ORH staff to consider other qualifications. The “or” condition is too broad and arbitrary for a regulation and unfair to Private Inspectors who have made the effort to comply with the existing regulation. Therefore, I opposed this exemption.

An exemption issued on May 1, 2021 related to the use of gonadal shielding addressed in 12VAC5-481-1591 (6) which exempts the gonadal shielding requirement for abdominal and pelvic x-rays as this shielding may interfere with the diagnostic area of interest.

The existing regulation states: 12VAC5-481-1591 (6). Gonad shielding of not less than 0.5 mm lead equivalent material shall be used for human patients, who have not passed the reproductive age, during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.

The underlined phrase at the end of the sentence provides the exemption that was requested. Therefore, this exemption was unnecessary. I suggest more than one ORH staffer review a proposed exemption before it is issued. A better approach would have been to address the issue by either a guidance document or a simple statement on the ORH website that the existing regulation is compatible with the National Council of Radiation Protection and Measurements’ position. Note: the Conference of Radiation Control Program Directors (CRCPD), which publishes the Suggest State Regulations issued an identical position paper.

The most objectionable exemption is the one issued on October 22, 2019. ORH approved a request “for an exemption from regulation 12 VAC 5-481-3380 and regulation 12 VAC 5-481-3390 of the Code of Virginia for the Sensus SRT-100”. Note: The exemption stated Code of Virginia, when in fact it is the Virginia Administrative Code.

The exemption allowed Sensus to market its superficial radiation therapy machine (Grenz Ray) to dermatologists in Virginia. Radiation therapy has not been typically used in dermatology and there is the expectation of training and experience to safely use this modality. Such criteria for dermatology does not exist in the current regulations. At least one insurance carrier, Aetna, considers this modality experimental in dermatology. https://www.aetna.com/cpb/medical/data/200_299/0231.html

There are at least three other manufactures of similar equipment that could benefit from such an exemption, i.e. X-cel X-ray Corporation

https://www.xcelxray.com/products/92-product-full-listing/474-grenz-ray-therapy-syste, BEBIG Medical GmbH https://www.bebigmedical.com/ and XSTRAHL https://xstrahl.com/

The issuance of this exemption also created a conflict with another VDH program, i.e. the Certificate of Public Need (COPN) Program. The Code of Virginia § 32.1-102.1:3 A. The following medical care facilities shall be subject to the provisions of this article:

6. Any specialized center or clinic or that portion of a physician's office developed for the provision of outpatient or ambulatory surgery, cardiac catheterization, computed tomographic (CT) scanning, magnetic resonance imaging (MRI), positron emission tomographic (PET) scanning, radiation therapy, stereotactic radiotherapy other than radiotherapy performed using a linear accelerator or other medical equipment that uses concentrated doses of high-energy X-rays to perform external beam radiation therapy, or proton beam therapy.

Note: I underlined radiation therapy for emphasis. Superficial therapy machines are a subset of radiation therapy machines. Facilities are supposed to seek approval under the COPN Program prior to the purchase of the equipment.  Physicians unfamiliar with the COPN requirements in their specialty will find themselves in conflict with these requirements. ORH should be providing the COPN Program with the Reports of Assembly for Diagnostic machines and new registrations for Therapy Radiation machines to ensure compliance with COPN requirements.

To summarize this Exemption provides an unfair advantage to one manufacturer to the disadvantage of at least three others, it did not address the public health considerations, and staff failed to understand its impact on other VDH programs. ORH staff had access for advice from resources such as the US FDA, which regulates the manufacture of radiation therapy machines, CRCPD, and the Radiation Advisory Board. This exemption should never have been issued and in my opinion is tantamount to malfeasance. I strongly oppose efforts to amend this regulation to support the exemption.

Abusive Use of Exemptions

I can confidently state that the VDH Radiation Protection Program had not issued any exemptions during the period 1986-2011. Yet in the past five years, a dozen or so exemptions have been issued. As previously mentioned, none of the exemptions were addressed in the Agency Background Document. One might conclude that VDH is using exemptions as a means of evading the rule making process and public participation as intended in the Administrative Process Act. I acknowledge the Administration may hold up the regulatory process for a lengthy period; however, that is no justification for circumventing the process.

I recommend:

Future exemptions are issued concurrently with a Notice of Intended Regulatory Action. If there are sufficient negative comments, then the agency should promptly terminate the exemption.

Consider publishing a webpage with links to all of the agency’s exemptions.

Consider a standard format that includes name of requestor, background on how the regulation conflicts with requestor’s proposed use of radiation, rationale for deviating from the regulation and impact on other entities and text for amending the regulation. Note: most of the exemptions issued did not provide any background information.

Consider replacing “physical sciences” with “natural sciences” for the degree qualifications for private inspectors in diagnostic X-ray and mammography. One would assume individuals interested in the medical/healthcare field would obtain a degree in biology or one of the life sciences before settling on radiation physics or health physics as a career choice. Natural science includes the physical sciences plus the life sciences.

I assume the Bachelor’s route for private inspectors of mammography equipment is no longer available and will be deleted in the revised regulation.  The existing regulation is cited for reference:

12VAC5-481-340. Private inspector qualifications.

1. Private inspector, diagnostic x-ray (except mammography).

1. Initial qualifications: evidenced by one or more of the following:

b. Bachelor's degree in one of the physical sciences or engineering and three years of full-time experience in radiation safety including at least one year in diagnostic x-ray safety. Advanced degrees in related areas may be substituted for experience on an equal time basis, except that no substitution shall be allowed for the required one year of experience in diagnostic x-ray safety.

2. Private inspector, mammography.

1. Initial qualifications:

Master Route:

b. A master's degree or higher in a physical science with at least 20 semester hours or equivalent of graduate or undergraduate physics; and

Bachelor Route (must have been qualified before April 28, 1999):

a. A bachelor's degree in a physical science with at least 10 semester hours or equivalent of college level physics;

Private inspectors' qualifications must conform with our accrediting bodies and FDA requirements, at the very least.  There is no such a thing as "natural science" as proposed by another commenter.  A bachelor's degree, only, must not qualify an individual for private inspector status.  Board certification must also be a requirement.

Both of these sections must be revised to conform with the advances made in equipment manufacturing.  All sections related to collimation must reflect that we are now dealing with digital image, as collimation testing needs to be redefined and revamped.

Some of the same comments I made in my previous comments for sections 1601 and 1611 apply here, as well.  This is the place to define tests required tests frequency.  I also suggest adding entrance skin exposure reference and tolerance values, as it already done in several states across the country.

This is most poorly written section, in my opinion.  There are too many loose ends, which creates problems for the medical physicist.  Unfortunately, unless it is mandated by regulation and/or accreditation requirements, facilities do not like what we have to say.  The QC program for CT must conform with the ACR accreditation program.  Decision also needs to be made if there should be a different set of requirements for CT units solely used for radiation oncology simulation, only.

This is the place where you need to define all components of a quality assurance program.  I also suggest that QA/QC guides be developed for each modality.  You could adopt NYS model program, minus their required testing frequencies.

This section should state that either the applicable ACR QC program or the mammography unit manufacturer QC program must be adhered to. Each facility must choose one QC program or the other; you cannot mix and match on a per unit basis. 

Given the limitations of available testing equipment and widespread use of digital image receptors leading to a decline in film and CR technology, a practical method needs to be defined for comparing the dimensions of the x-ray field in the plane of the image receptor to the visible area of the image receptor. 

It should be specified that the technique chart requirement is satisfied by pre-programmed settings on the radiographic or CT unit or a technique notebook at the control panel.

There should be a section that covers timelines and required postings for new equipment installations, much like what is found at this link: https://www.vdh.virginia.gov/radiological-health/radiological-health/x-ray-machine-program/medical-x-ray-machines/.

For example:

• how long after installation a unit must be registered and surveyed by a private inspector,
• how long a temporary unit may be used without being registered with VDH, and
• what postings are required at a new installation (e.g., list of operators, notice to employees, technique chart).

Private inspector survey requirements for diagnostic x-ray systems that are transferred between facilities within an institution should also be clarified (i.e., whether to treat it as a new installation or continue on the same schedule of routine surveys the unit was on before transfer) - including whether the requirements are the same for mobile units.

The regulations should more explicitly allow for discontinuing patient shielding as routine practice in accordance with current scientific literature and in consideration of new technology, as referenced in the AAPM position statement found here:

https://www.aapm.org/org/policies/details.asp?id=468

and supporting FAQ document found here:

https://www.aapm.org/org/policies/documents/CARES_FAQs_Patient_Shielding.pdf.

All VDH regulations must conform with federal regulations. For example, FDA regulation states that the coefficient of variation for radiographic air kerma reproducibility measurements must be no greater than 5% (https://www.ecfr.gov/current/title-21/part-1020/section-1020.31#p-1020.31(b)(1)), but the current VDH regulation specifies 10% (https://law.lis.virginia.gov/admincode/title12/agency5/chapter481/section1621/#:~:text=1.%20Coefficient%20of%20variation.%20For%20any%20specific%20combination%20of%20selected%20technique%20factors%2C%20the%20estimated%20coefficient%20of%20variation%20of%20the%20air%20kerma%20shall%20be%20no%20greater%20than%200.10.), exceeding the federally mandated tolerance limit.

7. Request that 12VAC5-481-1890 be revised to allow decay-in-storage for half-lives up to 271 days.  This regulatory requirement has an NRC compatibility of Health and Safey (H&S) which state:

    “Program elements identified by H&S in the Comment column are not required for purposes of           

     compatibility; however, they do have particular H&S significance. Although not required for

     compatibility, the State must adopt program elements in this category, that embody the basic H&S

     aspects of the NRC’s program elements because of particular H&S considerations.”  Other agreement

     states allow licensees to decay-in-storage beyond the 120 days listed in 12VAC5-481-1890.

8. Request that revisions to 12VAC5-481 or a new 12VAC5-482 include language that clarifies that therapeutic medical devices with integrated on-board X-ray based imaging systems used only for non-diagnostic and non-therapeutic purposes such as patient positioning and treatment verification do not require additional qualifications beyond what is required to use the therapeutic system. (For instance, gamma stereotactic radiosurgery systems with integrated on-board x-ray systems do not require qualifications beyond which is required for the gamma stereotactic radiosurgery system in order to operate the x-ray system). This would otherwise cause an undue burden to licensees.
9. Recommend that ORH inform all licensees and registrants when the proposed revisions are submitted to the Town Hall and post the information on the Laws and Regulations webpage.
10. Recommend that ORH have a “town hall” meeting with licensees and registrants to discuss the regulations.  This can be a virtual meeting to lessen the impact/burden.
11. Recommend that these regulation revisions have a public comment period of 90 days.  It will take a vast amount of time to review the entire regulation and formulate comments.

I agree that a substantial revision to Virginia’s radiation protection regulations (12VAC5-481) is needed.  Over time, the regulations governing radiation therapy have accumulated inconsistencies, ambiguities, and provisions that no longer align well with modern clinical practice.

However, it is not yet clear whether a full repeal of 12VAC5-481 and replacement with a new chapter (12VAC5-482) is the most appropriate path forward. Whether repeal-and-replace is justified depends critically on the scope, structure, and clarity of the revised regulations.
If the changes are incremental or limited in scope, a targeted revision may be preferable to a full replacement.

There are numerous issues in the current regulations that warrant correction; the following are provided as a few representative examples.

First, the current regulations incorporate radioactive material (RAM)–style language into therapeutic x-ray requirements. For example, requirements for a “Written Directive” are applied to therapeutic x-ray machines. In clinical radiation oncology practice, treatment is authorized through a physician-approved treatment prescription and treatment plan, not through a RAM-style written directive. Revised regulations should reflect accepted clinical workflows and terminology appropriate to external beam radiation therapy.

Second, the applicability of the current regulations is unclear.  For example, for therapeutic x-rays produced by a medical linear accelerator, it is ambiguous whether both the Part IX “Particle Accelerator” provisions and the Part XV “Therapeutic Radiation Machines” provisions apply simultaneously. This ambiguity leads to inconsistent interpretation and enforcement. Any revised regulations should be explicit regarding scope and applicability, clearly stating which sections apply to which technologies.

Third, the current regulations (12VAC5-481-2230) require therapeutic x-ray vaults to be equipped with an independent radiation monitoring system. This requirement raises significant clinical and operational concerns. Modern treatment vault safety is ensured primarily through door interlocks, in-room radiation indicators, and emergency-off systems, and the regulations should reflect that reality. Forbidding patient treatment when these independent monitoring systems inevitably fail causes far more harm than any potential added safety benefit from such systems. Furthermore, requiring annual calibration of a device whose functional purpose is simply to indicate beam on/off status provides little safety value, while device failure can unnecessarily interrupt patient treatments.

While no substitute regulatory text for 12VAC5-481 has yet been published, it should be noted that direct or near-verbatim adoption of the current CRCPD Suggested State Regulations for the Control of Radiation (SSRCRs) would require careful evaluation, as several unresolved issues remain in the model language.

The examples below are intended to be illustrative rather than exhaustive.

For example, the CRCPD definition of a Quality Management Program differs substantially from widely accepted quality management frameworks (e.g., ISO 9000 series). The CRCPD definition focuses primarily on identifying deficiencies and deviations, rather than on continuous improvement and process control.

Additionally, CRCPD Part X, Section X.7(u), requires that therapeutic treatment facilities either be accredited by an external organization or undergo an audit described in the appendices. The audit process described in the associated materials extends beyond regulatory requirements and functions more like an accreditation checklist.
Any audit requirement included in Virginia regulations should be strictly limited to verifying compliance with explicit regulatory provisions and should not incorporate extra-regulatory expectations.

CRCPD Part X, Section X.3(d), requires professional certification for Qualified Medical Physicists. However, certification boards require clinical experience for eligibility.
Without an explicit grace period or transitional pathway, newly graduated physicists cannot legally practice long enough to obtain the experience required for certification, creating an unintended workforce barrier.

Finally, CRCPD Part X, Section X.8(b), requires calibration at electronic brachytherapy source energies. Such calibration energies are not provided by Accredited Dosimetry Calibration Laboratories (ADCLs), rendering this requirement impractical and unenforceable in its current form.

Given the number of unresolved issues within both the existing regulations and the CRCPD framework, and the inherent challenges associated with revising complex clinical regulations, any proposed replacement regulations should be accompanied by a substantial public comment period prior to adoption. This will help ensure that the final regulations are clear, implementable, and aligned with safe and effective clinical practice.

I agree that the regulations in the current 12VAC5-481 would benefit from significant revision or replacement. The existing regulations have areas which suffer from ambiguities regarding which regulations apply to different areas of clinical/research practice.

Some representative examples:

1. The current regulations appear to apply specific radioactive material definitions to therapeutic x-ray machine uses. (For example, the definitions of "Written Directive", "Medical Event", "Authorized User"). This tends to be a source of confusion for licensees and users of both radioactive material-based and x-ray based equipment.
2. Certain definitions addressing the same concept are inconsistent (for instance, "Medical Event", "Misadministration", and "Reportable Event").
3. The definition of "Radiation Machine" is confusing as it currently excludes devices whose only source of radiation is radioactive material.
4. Proposed revisions/replacement regulations should more clearly state which regulations apply to different categories of devices (radioactive material-based, x-ray based, charged particle based) to resolve current ambiguities.

The current 12VAC5-481 regulations have also fallen behind developments in both clinical radiation oncology practice and preclinical radiation research. In particular:

1. Many clinical treatment devices now include integrated x-ray-based "on-board" imaging systems that are used to verify patient position on the device (i.e. they are non-diagnostic and non-therapeutic). Current regulations are ambiguous in how these non-diagnostic, non-therapeutic x-ray systems should be regulated.  Any revision/replacement of 12VAC5-481 should address these devices and should recognize that as they are an integrated part of a therapeutic treatment system, the positioning/verification x-ray systems should not require qualifications for operation beyond which is required to use the primary therapeutic device. Deciding otherwise could in some cases place an undue burden on operators/licensees. (This is particularly the case for devices that use radioactive material for therapy purposes, and integrated on-board x-rays for treatment positioning and verification).
2. Non-human use, pre-clinical cell-irradiation and animal-irradiation systems are not well-addressed under current regulations. Proposed revisions/replacements should address these devices as a class of devices separate from "analytical x-ray systems".

A revision or replacement of the regulations with attention to consistency and addressing recent developments in radiation delivery technology will lower the cost of compliance for licensees and operators and will ultimately accrue to the benefit of public safety and therapeutic effectiveness.

I agree with previous comment regarding the need for Office of Radiological Health (ORH) staff to engage the regulated community via “town hall” meetings, regulatory information on ORH website and attend professional meetings such as local chapters of the Health Physics Society and American Association of Physicists in Medicine.

The comment regarding the sharing of proposed regulations in the formative stage may have some basis in the Code of Virginia:

§ 32.1-228.1. Department designated state radiation control agency; powers and duties.

B. The Department shall:

c. Establishing and maintaining a file of all agency rules and regulations related to regulation of sources of radiation, pending or promulgated, and proceedings thereon.

I see no reason why the pending regulations cannot be shared with the regulated community as suggested by a previous commenter.

I agree with comment regarding exemptions for certain excreta. There was an outpatient treated with I-125 and the patient had the sniffles. Tissue went into the trash and set off the radiation detector at the municipal landfill. The tissue was traced back to the patient and waste service threatens termination of waste disposal service. Patient was not provided adequate instructions, though not always possible to cover all situations.

I encourage ORH staff refrain from repeal and replace 12VAC-481 for reasons cited by previous commenter. It would also be helpful to use same format and verbiage as the “Suggested State Regulations” published by the Conference of Radiation Control Program Directors, Inc., except in the case of radioactive materials where the U.S. Nuclear Regulatory Commission takes precedence. Uniformity of the regulations were possible would be helpful to those familiar with regulations of other states.