WSR 99-01-094

PROPOSED RULES

DEPARTMENT OF HEALTH

[Filed December 17, 1998, 9:55 a.m.]



Original Notice.

Preproposal statement of inquiry was filed as WSR 98-06-078.

Title of Rule: Delete unnecessary annual dosimetry reporting requirement.

Purpose: This rule amends WAC 246-221-265 to delete the requirement that certain radioactive materials licensees annually report to the department their results of personnel dosimetry monitoring.

Statutory Authority for Adoption: RCW 70.98.050 and 70.98.080.

Statute Being Implemented: RCW 70.98.050 and 70.98.080.

Summary: In 1994, during a major revision of all radiation rules required by the United States Nuclear Regulatory Commission, a rule requiring certain radioactive materials licensees to annually report the results of personnel dosimetry was inadvertently added to the regulations. The NRC collects and analyzes this data from its own licensees, however, NRC does not require this data from Washington state licensees and there is no reason for the state radiation control agency to demand it from them. Washington state licensees have attempted to comply with this regulation because it exists in WAC. Collecting, copying and sending this information to the state is an unnecessary burden for Washington state licensees and should be deleted from WAC 246-221-265.

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Terry C. Frazee, Tumwater, (360) 236-3221.

Name of Proponent: Division of Radiation Protection, Department of Health, governmental.

Rule is not necessitated by federal law, federal or state court decision.

Explanation of Rule, its Purpose, and Anticipated Effects: This rule deletes an unnecessary requirement for reporting information to the department. The rule relieves licensees of the time and expense of reporting annual dosimetry results for which the department has no immediate use.

Proposal Changes the Following Existing Rules: WAC 246-221-265 (2) through (5) are deleted; thus removing the requirement for certain licensees to annually report to the department the results of individual personnel dosimetry monitoring.

A small business economic impact statement has been prepared under chapter 19.85 RCW.



Small Business Economic Impact Statement

significant legislative rule analysis,

economic impact analysis

and

small business economic impact statement

for

WAC 246-221-265 Special Reports to the Department



Background.

The Division of Radiation Protection regulates the uses of ionizing radiation throughout the state. This includes most radioactive materials as a result of a formal agreement with the United States Nuclear Regulatory Commission (NRC). As part of the agreement, the state must maintain its regulations compatible with specified NRC rules. In 1994, during a major revision of all radiation rules as required by the NRC, a rule requiring certain radioactive materials licensees to annually report the results of personnel dosimetry was inadvertently added to the regulations. While the NRC collects and analyzes this data from some of its own licensees, it does not require this data from Washington state licensees. This rule is not required for compatibility and there is no reason for the division to impose this requirement on its licensees.



A. Clearly state in detail the general goals and specific objectives of the statute that the rule implements.

The department has the authority to "formulate, adopt, promulgate, and repeal codes, rules and regulations relating to control of sources of ionizing radiation" under RCW 70.98.050 and, as a matter of policy, the department is "to institute and maintain a regulatory and inspection program for sources and uses of ionizing radiation so as to provide for (1) compatibility with the standards and regulatory programs of the federal government" (RCW 70.98.010). Furthermore, the department is to reduce "the disproportionate impact of state administrative rules on small business" (RCW 19.85.011). Finally, the legislature intends that a "rule that is no longer necessary because of changed circumstances" be repealed (RCW 34.05.354 (1)(c)). The rule change being proposed will remove a requirement that is not needed for compatibility with the United States Nuclear Regulatory Commission and is an unnecessary cost to our licensees, many of which are small businesses.



B. Determine that the rule is needed to achieve the general goals and specific objectives stated under question A and analyze alternatives to rule making and the consequences of not adopting the rule.

The proposed rule is needed to achieve the legislative goal of removing unnecessary requirements. The alternatives are to periodically inform licensees that compliance is not necessary despite the rule language or to do nothing. Even though the division has generally let it be known that annual reporting of dosimetry results is not expected, some Washington state licensees have attempted to comply with this regulation simply because it exists in WAC. Collecting, copying and sending this information to the division is a small but unnecessary cost for these licensees. For this reason the division proposes to remove this requirement from the rules by amending WAC 246-221-265. The expedited repeal process cannot be used because the section also contains other provisions required for compatibility with the NRC.



C. Determine that the probable benefits of the rule are greater than its probable costs.

The benefit of the current rule, which requires licensees to submit reports on dosimetry, provides the department with early access to dosimetry data. However, the department reviews dosimetry on its regular inspections of licensed facilities (the inspection frequency ranges from every year to every three years). Therefore, annual reporting of dosimetry results provides no additional public health benefit but a cost to the licensees. (Note: This rule does not affect the separate requirement that licensees immediately report overexposures which are then investigated by the department.) Eliminating this reporting requirement provides a cost savings to licensees with no reduction in public health protection.



Economic Impact Analysis.

The division licenses approximately four hundred users of radioactive materials. Of these, about fifteen licensees are required by the existing regulation to submit annual dosimetry results. The cost associated with this reporting requirement consists of:

Activity Approximate Time Cost

(at $30/hr)

Collecting appropriate reports 60 minutes $30
Making copies 20 minutes $10
Preparing cover letter 20 minutes $10
Postage and handling 10 minutes $5 (plus $1 for stamps)
TOTAL $56



The total cost to licensees for compliance with the existing rule is 15 times $56 or approximately $840 per year. The effect of the proposed rule is to eliminate this cost entirely, resulting in a savings of $840 per year.



D. Determine after considering alternative versions of the rule and the analysis required under questions B and C, that the rule being adopted is the least burdensome alternative for those required to comply.

This proposed rule removes a burden placed on certain licensees and is therefore the "least burdensome alternative."



E. Determine that the rule does not require those to whom it applies to violate the requirements of another state or federal law.

The proposed rule will not require the violation of any other state or federal law.



F. Determine that the rule does not impose more stringent performance requirements on private than on public entities unless required to do so by federal or state law.

The proposed rule will not impose more stringent performance requirements on private than on public entities.



G. Determine that if the rule differs from any federal regulation or statute applicable to the same activity or subject matter and, if so, determine that the difference is justified.

The proposed rule will not differ from other state or federal regulations.



H. Coordinate the rule, to the maximum extent practicable, with other federal, state, and local laws applicable to the same activity or subject matter.

The department has conferred with the United States Nuclear Regulatory Commission on this rule.



Small Business Economic Impact Analysis.

Chapter 19.85 RCW, the Regulatory Fairness Act, requires agencies to consider the impact of administrative regulations on small businesses. The proposed rule amendment relieves licensees of the burden of routinely reporting dosimetry results to the division. This rule will provide the same relief to small businesses as it does to any other businesses subject to the reporting requirement. By its very nature this rule will be proportionately a greater benefit to small licensees that would ordinarily be required to report their dosimetry results than to larger businesses which are inherently more capable of absorbing trivial costs. No further analysis of the impact to small businesses is necessary.

This rule eliminates a requirement and is beneficial to the few licensees affected.



A copy of the statement may be obtained by writing to Terry C. Frazee, Supervisor, Radioactive Materials Section, P.O. Box 47827, Olympia, WA 98504-7827, phone (360) 236-3221, fax (360) 236-2255.

Section 201, chapter 403, Laws of 1995, applies to this rule adoption. This rule change falls within the definition of a significant legislative rule.

Hearing Location: Department of Health, Division of Radiation Protection, Airdustrial Center, Building 5, Tumwater, Washington, on January 27, 1999, at 10:00 a.m.

Assistance for Persons with Disabilities: Contact Terry Frazee by January 26, 1999, TDD (800) 833-6388 or fax (360) 236-2255.

Submit Written Comments to: Terry Frazee, fax (360) 236-3221 by January 27, 1999.

Date of Intended Adoption: February 3, 1999.

December 15, 1998

Kristine Van Gorkom

Deputy Secretary

OTS-2025.2

AMENDATORY SECTION (Amending WSR 94-01-073, filed 12/9/93, effective 1/9/94)



WAC 246-221-265  Special reports to the department--Planned special exposures((, individual monitoring results from certain licensees,)) and leaking sources. (1) The licensee or registrant shall submit a written report to the department within thirty days following any planned special exposure conducted in accordance with WAC 246-221-030((, informing)). The written report shall:

(a) Inform the department that a planned special exposure was conducted ((and indicating));

(b) Indicate the date the planned special exposure occurred; and

(c) Provide the information required by WAC 246-221-030.

(2) ((Each licensee in a category listed in subsection (3) of this section shall submit an annual report of the results of individual monitoring carried out by the licensee for each individual for whom monitoring was required by WAC 246-221-090 and 246-221-100 during that year. The licensee may include additional data for individuals for whom monitoring was provided but not required. The licensee shall use department Form RHF-5A or electronic media containing all the information required by department Form 5A.

(3) The requirement to submit individual monitoring results annually applies to each person licensed by the department to:

(a) Possess or use sources of radiation for purposes of industrial radiography pursuant to chapters 246-235 and 246-243 WAC; or

(b) Receive radioactive waste from other persons for disposal pursuant to chapter 246-250 WAC; or

(c) Possess or use at any time, for processing or manufacturing for distribution pursuant to chapter 246-235 WAC, radioactive material in quantities exceeding any one of the following quantities:





Radionuclide Activity
Ci GBq
Cesium-137 1 37
Cobalt-60 1 37
Gold-198 100 3,700
Iodine-131 1 37
Iridium-192 10 370
Krypton-85 1,000 37,000
Promethium-147 10 370
Technetium-99m 1,000 37,000




(4) The department may require as a license condition, or by rule, regulation, or order pursuant to WAC 246-220-100, reports of annual individual monitoring results from licensees processing or manufacturing for distribution radionuclides not on the list in subsection (3)(c) of this section, provided the radionuclides are in quantities sufficient to cause comparable radiation levels to those on the list.

(5) The licensee shall file the report required by subsection (2) of this section, covering the preceding year, on or before April 30 of each year. The licensee shall submit the report to the department.

(6))) The licensee shall file a written report with the department within five days after learning that a sealed source is leaking or contaminated. The report shall describe:

(a) The source((,));

(b) The source holder((,));

(c) The equipment in which the source is installed((,));

(d) The test results; and

(e) The corrective action taken.



[Statutory Authority: RCW 70.98.050. 94-01-073, 246-221-265, filed 12/9/93, effective 1/9/94.]

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