DAR File No. 39017

Environmental Quality, Radiation Control

Rule R313-35

Requirements for X-ray Equipment Used for Non-Medical Applications

Notice of Proposed Rule

(Amendment)

DAR File No.: 39017
Filed: 12/19/2014 09:55:21 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The reason for the change is based on a petition for rulemaking. The petitioner requested that hand-held non-medical X-ray systems be allowed for use by registrants. During a review of the petition, the Utah Radiation Control Board determined that rulemaking proceedings should be initiated to address the petition.

Summary of the rule or change:

The proposed change to Rule R313-35 adds a definition for "forensics x-ray" and a new Section R313-35-105. This section outlines the requirements that apply to the use of hand-held non-medical x-ray equipment. The rule requires that each operator of hand-held non-medical x-ray equipment complete training supplied by the manufacturer and keep records of the training. The rule also specifies that the provision in Subsection R313-35-110(1)(d) is optional.

State statutory or constitutional authorization for this rule:

• Subsection 19-3-104(4)
• Section 19-3-108

Anticipated cost or savings to:

the state budget:

There is no additional cost to the state budget because a registration and radiation safety inspection program exists for all types of x-ray systems. Allowing the use of hand-held non-medical x-ray systems will generate some additional revenue for the registration and inspection of such systems. Because the number of systems to be purchased by businesses is unknown, the amount of this additional revenue is also unknown.

local governments:

Local government agencies may have a need to acquire a hand-held non-medical x-ray system. The cost for registering the system is $35 per year and the inspection cost is $75 per inspection.

small businesses:

The Division of Radiation Control is currently regulating many non-medical facilities that are a small business. If the facility acquires a hand-held non-medical x-ray system, the cost for registering the system is $35 per year and the inspection cost is $75 per inspection.

persons other than small businesses, businesses, or local governmental entities:

The Division of Radiation Control is currently regulating many non-medical facilities that fit within the definition of person. The cost to all persons that acquire a hand-held non-medical x-ray system is $35 per year for registering the system and $75 per radiation safety inspection.

Compliance costs for affected persons:

There is compliance cost for a protective apron. The average cost for a protective apron is $150.

Comments by the department head on the fiscal impact the rule may have on businesses:

There exists a regulatory program within the department to register x-ray machines and to perform a radiation safety inspection of x-ray systems. The annual registration fee is $35 per x-ray tube and the inspection fee is $75 per inspection. Facilities that own a hand-held non-medical x-ray system will be required to pay these fees. A regulated facility with a hand-held non-medical x-ray system will have to obtain protective aprons to protect the operator of the x-ray system. The cost for a protective apron is minimal and is about $150 per apron.

Amanda Smith, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Environmental Quality
Radiation ControlRoom Third Floor
195 N 1950 W
SALT LAKE CITY, UT 84116-3085

Direct questions regarding this rule to:

• Craig Jones at the above address, by phone at 801-536-4264, by FAX at 801-533-4097, or by Internet E-mail at cwjones@utah.gov
• John Hultquist at the above address, by phone at 801-536-4263, by FAX at 801-536-4250, or by Internet E-mail at jhultquist@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

02/17/2015

This rule may become effective on:

03/17/2015

Authorized by:

Rusty Lundberg, Director

R313. Environmental Quality, Radiation Control.

R313-35. Requirements for X-Ray Equipment Used for Non-Medical Applications.

R313-35-2. Definitions.

As used in R313-35:

"Analytical x-ray system" means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials by either x-ray fluorescence or diffraction analysis.

"Cabinet x-ray system" means an x-ray system with the x-ray tube installed in an enclosure, hereinafter termed "cabinet," which, independent of existing architectural structure except the floor on which it may be placed, is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of x-radiation. Included are all x-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad and bus terminals, and similar facilities. An x-ray tube used within a shielded part of a building, or x-ray equipment which may temporarily or occasionally incorporate portable shielding is not considered a cabinet x-ray system.

"Collimator" means a device used to limit the size, shape and direction of the primary radiation beam.

"Direct reading dosimeter" means an ion-chamber pocket dosimeter or an electronic personal dosimeter.

"External surface" means the outside surfaces of cabinet x-ray systems, including the high-voltage generator, doors, access panels, latches, control knobs, and other permanently mounted hardware and including the plane across an aperture or port.

"Fail-safe characteristics" means design features which cause beam port shutters to close, or otherwise prevent emergence of the primary beam, upon the failure of a safety or warning device.

"Forensics x-ray" means the use of x-ray systems in forensic autopsies of deceased humans, police agency use of x-ray systems for evidence identification and testing, or x-ray system use for arson or questionable origin fire investigations.

"Nondestructive testing" means the examination of the macroscopic structure of materials by nondestructive methods utilizing x-ray sources of radiation.

"Non-medical applications" means uses of x-ray systems except those used for providing diagnostic information or therapy on human patients.

"Normal operating procedures" means instructions necessary to accomplish the x-ray procedure being performed. These procedures shall include positioning of the equipment and the object being examined, equipment alignment, routine maintenance by the registrant, and data recording procedures which are related to radiation safety.

"Open-beam configuration" means a mode of operation of an analytical x-ray system in which individuals could accidentally place some part of the body into the primary beam during normal operation if no further safety devices are incorporated.

"Portable package inspection system" means a portable x-ray system designed and used for determining the presence of explosives in a package.

"Primary beam" means ionizing radiation which passes through an aperture of the source housing via a direct path from the x-ray tube located in the radiation source housing.

"Very high radiation area" means an area, accessible to individuals, in which radiation levels could result in individuals receiving an absorbed dose in excess of five Gy (500 rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

"X-ray system" means an assemblage of components for the controlled production of x-rays. It includes, minimally, an x-ray high-voltage generator, an x-ray control, a tube housing assembly, and the necessary supporting structures. Additional components which function with the system are considered integral parts of the system.

 

R313-35-105. Portable, Hand-Held, Non-Medical X-ray Systems.

(1) In addition to compliance to the provisions of Rule R313-35 the following sections are specific to portable, hand-held, non-medical x-ray systems:

(a) Protective aprons of at least 0.5 millimeter lead equivalence shall be provided for the operator to protect the operator's torso and gonads from backscatter radiation while operating the x-ray source;

(b) Each operator of hand-held x-ray systems shall complete a training program supplied by the manufacturer prior to using the x-ray system. Records of training shall be maintained on file for examination by an authorized representative of the Director; and

(c) For hand-held x-ray systems, the provision in Subsection R313-35-110(1)(d) of the length of electrical cord for the dead-man switch is optional.

 

KEY: industry, x-rays, veterinarians, surveys

Date of Enactment or Last Substantive Amendment: [March 19, 2013]2015

Notice of Continuation: March 2, 2012

Authorizing, and Implemented or Interpreted Law: 19-3-104; 19-3-108