DAR File No. 41181

Environmental Quality, Waste Management and Radiation Control, Radiation

Rule R313-34

Requirements for Irradiators

Five-Year Notice of Review and Statement of Continuation

DAR File No.: 41181
Filed: 01/17/2017 09:57:40 AM

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) creates the Waste Management and 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:

During the period from the previous five-year review, one modification to the rule was made. Comments received for the modification were related to the modification only and no comments were received either expressing support or opposition to the rule during the comment period on the modification or at any other time during the period from the previous five-year review.

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. As an Agreement State, this rule is needed to maintain regulatory compatibility with the U.S. Nuclear Regulatory Commission (NRC).

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

Environmental Quality
Waste Management and Radiation Control, RadiationRoom Third Floor
195 N 1950 W
SALT LAKE CITY, UT 84116-3085

Direct questions regarding this rule to:

• Rusty Lundberg at the above address, by phone at 801-536-4257, by FAX at 801-536-0222, or by Internet E-mail at rlundberg@utah.gov

Effective:

01/17/2017

Authorized by:

Scott Anderson, Director