No. 27991 (Amendment): R313-16. General Requirements Applicable to the Installation, Registration, Inspection, and Use of Radiation Machines

DAR File No.: 27991
Filed: 06/06/2005, 12:05
Received by: NL

 

RULE ANALYSIS

Purpose of the rule or reason for the change:

The Radiation Control Board observed that renewal of a registration certificate as a Qualified Expert was more rigorous than obtaining an initial certificate. The Board instructed the Division of Radiation Control to propose an amendment to the rule.

 

Summary of the rule or change:

Subsection R313-16-293(3) was added so that the initial requirements to obtain a registration certificate as a Qualified Expert includes the submission of two inspection reports for work performed within the last two years. This is a new requirement for initial applicants and it makes the requirements consistent with the renewal requirements in Section R313-16-296. Subsection R313-16-296(1) was reformatted to include Subsections R313-16-296(1)(a) and R313-16-296(1)(b). An introductory statement was added to clarify that timely renewal of a registration certificate involves completion of both subsections. Subsection R313-16-296(2) was renumbered as R313-16-296(1)(b). This subsection includes a clarification that qualified experts must attach to their renewal applications documentation that they performed the minimum number of inspections in Utah each year the registration certificate was in effect. New requirements were also added so that, if registered individuals did not complete the required inspections in Utah, they could renew their certificates by relying upon inspection work completed in another jurisdiction. In these circumstances, applicants must submit documentation on four inspections. Subsection R313-16-296(2) was added so that there is a clear consequence for failing to renew a registration certificate.

 

State statutory or constitutional authorization for this rule:

Sections 19-3-104 and 19-3-108

 

Anticipated cost or savings to:

the state budget:

The additional regulatory requirements do not affect the records management practices of the Agency. Therefore, the changes will not result in a cost or savings to the State Budget.

 

local governments:

The rules that are being changed do not affect local governments because there are no local governments that employ a Qualified Expert. Therefore, there will be no cost or savings for local governments.

 

other persons:

The changes to the rule only apply to persons registered under Section R313-16-293. Currently, there are ten individuals registered as a Qualified Expert and each registration is valid through January 31, 2008. If they all seek reregistration and the individual cost, as outlined under "Affected persons" below is $10, then the aggregate anticipated cost is $100 every 3 years. The Division of Radiation Control has no way of anticipating the possible number of new applicants, so further refinement of this cost analysis is not possible.

 

Compliance costs for affected persons:

Compliance costs for affected persons will likely be less than $10 every 3 years. The costs are associated with copying and mailing documents to the Agency.

 

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

Inspection services performed by independent consultants, Qualified Experts, are generally owner operated businesses. The fiscal impact the rule may have on businesses is expected to be the same as the compliance costs for affected persons. Dianne R. Nielson, 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 Control
168 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 [e-mail]

 

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:

08/01/2005

 

This rule may become effective on:

08/12/2005

 

Authorized by:

Dane Finerfrock, Director

 

 

RULE TEXT

R313. Environmental Quality, Radiation Control.

R313-16. General Requirements Applicable to the Installation, Registration, Inspection, and Use of Radiation Machines.

R313-16-293. Application for Registration of Inspection Services.

(1) Each qualified expert who is providing or offering to provide inspection services at facilities registered with the Executive Secretary shall complete an application for registration on a form prescribed by the Executive Secretary and shall submit all information required by the Executive Secretary as indicated on the form. A qualified expert must complete the registration process prior to providing services.

(2) Individuals applying for registration under Section R313-16-293 shall personally sign and submit to the Executive Secretary an attestation statement:

(a) that they have read and understand the requirements of these rules; and

(b) that they will document inspection items defined by the Executive Secretary on a form prescribed by the Executive Secretary; and

(c) that they will follow guidelines for the evaluation of x-ray equipment defined by the Executive Secretary; and

(d) that, except for those facilities where a registered qualified expert is a full-time employee, they will limit inspections to facilities with which they have no direct conflict of interest; and

(e) that radiation exposure measurements and peak tube potential measurements will be made with instruments which have been calibrated biennially by the manufacturer of the instrument or by a calibration laboratory accredited in x-ray calibration procedures by the American Association of Physicians in Medicine, American Association for Laboratory Accreditation, Conference of Radiation Control Program Directors, Health Physics Society or the National Voluntary Laboratory Accreditation Program; and

(f) that the calibration of radiation exposure measuring and peak tube potential measuring instruments used to evaluate compliance of x-ray systems with the requirements of these rules will include at least secondary level traceability to a National Institute of Standards and Technology, or similar international agency, transfer standard instrument or transfer standard source; and

(g) that they will make available to representatives of the Executive Secretary documents concerning the calibration of any radiation exposure measuring or peak tube potential measuring instrument used to evaluate compliance of x-ray systems; and

(h) that they or the registrant will submit to the Executive Secretary, within 30 calendar days after completion of an inspection, a written report of compliance or noncompliance; and

(i) that reports of items of noncompliance will include:

(i) the name of the facility inspected, and

(ii) the date of the inspection, and

(iii) the manufacturer, model number, and serial number or Utah identification number of the control unit for the radiation machine, and

(iv) the requirements of the rule where compliance was not achieved, and

(v) the manner in which the facility or radiation machine failed to meet the requirements, and

(vi) a signed commitment from the registrant of the radiation machine facility that the problem will be fixed within 30 days of the date the written report of noncompliance is submitted to the Executive Secretary; and

(vii) that all reports of compliance or noncompliance will contain a statement signed by the qualified expert acknowledging under penalties of law that all information contained in the report is truthful, accurate, and complete; and

(viii) that they acknowledge that they are subject to the provisions of Section R313-16-300.

(3) Individuals applying for registration under Section R313-16-293 shall attach to their application a copy of two inspection reports that demonstrate their work product follows the evaluation guidelines defined by the Executive Secretary pursuant to Subsection R313-16-293(2)(c). The inspection reports shall pertain to inspections performed within the last two years.

 

R313-16-296. Renewal of Registration Certificate for Inspection Services.

(1) Timely renewal of a registration certificate for inspection services is possible when:

(a) the [Q]qualified expert[s] [shall] files an application for renewal of a registration certificate for inspection services 30 days in advance of the registration certificate expiration date and in accordance with Section R313-16-293[.], and

[(2)](b) the qualified expert[Applicants shall] attaches to the application documentation that they performed a minimum of two inspections in Utah under these rules each year the previous registration certificate was in effect. An applicant who did not complete the minimum number of inspections in Utah may, as an alternative, attach to the application documentation that they performed four inspections at facilities in other states. These four inspections shall demonstrate their work product follows the evaluation guidelines defined by the Executive Secretary pursuant to Subsection R313-16-293(2)(c).

(2) A registered qualified expert who allows a registration certificate to expire is no longer a qualified expert and may not perform inspection services that will be accepted by the Executive Secretary. Reapplication may be accomplished pursuant to Section R313-16-293.

 

KEY: x-ray, inspection

[December 14, 2001]2005

Notice of Continuation July 23, 2001

19-3-104