DAR File No. 39046

Environmental Quality, Radiation Control

Rule R313-34

Requirements for Irradiators

Five-Year Notice of Review and Statement of Continuation

DAR File No.: 39046
Filed: 12/31/2014 01:50:11 PM

NOTICE OF REVIEW AND STATEMENT OF CONTINUATION

Concise explanation of the particular statutory provisions under which the rule is enacted and how these provisions authorize or require the rule:

Subsection 19-1-106(1) created the Radiation Control Board within the Department of Environmental Quality. Subsection 19-3-104(4) provides that the Board may make rules necessary for controlling exposures to sources of radiation that constitute a significant health hazard and to meet the requirements of federal law relating to radiation control.

Summary of written comments received during and since the last five-year review of the rule from interested persons supporting or opposing the rule:

This has not been a controversial rule. The Radiation Control Board recommends the continuation of the rule. No written comments have been received from the public.

Reasoned justification for continuation of the rule, including reasons why the agency disagrees with comments in opposition to the rule, if any:

This rule must be continued because it establishes the requirements for the possession and use of sealed sources containing radioactive materials in irradiators. These devices use high levels of gamma radiation to sterilize various products, primarily medical devices and pharmaceutical chemicals. The rule provides for protection of public health and safety by controlling the use of panoramic irradiators that have either dry or wet storage of the radioactive sealed sources; underwater irradiators in which both the source and object being irradiated are under water; and irradiators whose dose rate exceeds 55 rad per hour at one meter from the radioactive source in air or in water. A licensed facility currently operates a panoramic dry-exposure irradiator in Salt Lake County. The facility has been operating safely since January of 1990.

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:

• Mike Givens at the above address, by phone at 801-536-0278, by FAX at 801-533-4097, or by Internet E-mail at mgivens@utah.gov

Effective:

12/31/2014

Authorized by:

Rusty Lundberg, Director