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.