TOPIC 4: Role of Regulatory Agencies

Let’s explore the role of the regulatory agencies.

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The ALARA Concept

We have previously discussed ALARA – As Low As Reasonably Achievable..  Reasonably is the keyword in ALARA. There are three factors used in evaluating the concept of reasonableness: engineering, training, and procedures.

1The first factor is Engineering. Is the engineering in place sufficient to reduce the dose to the workers and the public to an acceptable level? Is it reasonable to install $1,000,000 of engineering controls to reduce the employee’s annual dose by 1 mrem? No. Is placing a lead shield between your desk and the radionuclide storage locker located on the other side of the wall to reduce the exposure rate from 10 mR/hour to 1 mR/hour reasonable? Yes.

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The second factor is Training. How much training is enough? The regulations prescribe the minimum amount of training required for certain types of radiation workers. Industry uses this benchmark and enhances the amount of training to be commensurate with the activities at their facility to include refresher training. If your facility lists additional training or refresher intervals on their radioactive materials license that are more restrictive than the regulations, your facility’s license controls.

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The third factor is Procedures. If the engineering is too costly and the amount of training may be impractical, then having more specific procedures in place can help reduce exposures. Procedures are implemented with a combination of experts, knowledge, and practical wisdom from the workers. Reviewing and modifying procedures should always be a dynamic activity that is constantly enhancing the program at minimal cost to the company and maximum safety to workers, the public and the environment.

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Inspections

With the issuance of a radioactive materials license, regulators will periodically inspect the compliance of the facility and its ability to properly handle and maintain the radioactive material.

There are a variety of items the regulator can inspect, such as labels on the sources, proper signs around the sources, effective dosimetry program, exposure rates around the sources, up-to-date leak test results, accurate inventory and transfer records, training records of the Authorized Users, etc.

The inspector can enter the facility unannounced at any time the facility is open and expect to be met by the RSO or his representative.

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When licensing of radioactive material is required, there is help available from both the USNRC and agreement states. To ensure compatibility of radiation safety programs, the USNRC and the agreement states prepare regulation guides (REGUIDES) to assist the licensee in the handling of radioactive materials in their programs.

For example, in order to obtain a radioactive materials license from a state, there may be a REGUIDE addressing the licensing issues that must be addressed.

These REGUIDES were primarily objective, and generally not prescriptive, meaning they are guides only. Over the last 10 years; however, these REGUIDES have become defacto regulations. In other words, the REGUIDES have become the standard and any deviation from them requires justification or submittal of equivalent procedures.

REGUIDES has the application format, standardized procedures, recordkeeping guidelines, forms that can be replicated and used, and the minimum criteria that will be typically required in order to obtain a license.

Many of these standardized procedures in the REGUIDE may be copied and used in the application.

However, if the applicant intends to have limited use for the radioactive materials or devices, the applicant may be overly committing to procedures that would not be necessary.

In this case, having a customized application format would be less restrictive during the operations.

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Sealed Source & Device Registry (SSDR)

For the regulation of sealed sources, each source and source holder must first be registered with the USNRC in the Sealed Source & Device Registry. This registration includes an application by the manufacturer of the device providing details to the regulator as to the maximum radioactivity of the sealed source that can be used in the device, the only authorized uses, the maintenance schedules, the recommended leak testing frequency, and any special training needed by the user.

Information about a sealed source sold for commercial use can be obtained from the USNRC Sealed Source and Device Registry (SSDR), through the Agreement State, or the manufacturer.

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The SSDR provides detailed drawings of the source within the source holder.

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As an example.  Nuclear density gauges such as these are described on the Sealed Source & Device Registry.  For reference, a nuclear density gauge is used to measure densities of materials or product levels in manufacturing facilities. A common density gauge configuration is shown. There is a hole in the source holder designed to shape the radiation beam into a cone as it is emitted (like a flashlight beam). The equipment is arranged to detect the beam on the other side of the pipe. As radiation travels along any path to the detector, it is “attenuated.” This means that anything the radiation encounters will absorb some of its energy. In essence, the more dense the material, the less radiation is detected on the other side of the pipe.  Therefore, we have an effective method of detecting density in the pipe.  The SSDR provides information about the radiation levels that are anticipated when using these devices.

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Radiation Dose Limits

When handling radioactive material at any facility, regulations identify two types of workers – radiation workers and members of the public (MOP).

A radiation worker is an individual that:

-has received sufficient radiation training as approved by the regulator, and,

-has also been approved by the RSO to work with radioactive materials,

-may have a dosimeter assigned when working with the radioactive material.

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We’ve previously talked about the Notice to Employees and it is worth repeating. All workers at the plant must be able to see the “NOTICE TO EMPLOYEES” posting. The purpose of this posting is to tell any workers at the plant that if they have questions regarding the procedures, the license, or the radiation activities at the site, they can find this information at the designated location stated on the NOTICE. And, if the employee is not satisfied with the information, the employee can call the regulatory agency to obtain answers or ask for an investigation. This is an extremely important posting and is a violation if not posted. It is important to keep it posted and accurate.