WSR 00-21-118

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed October 18, 2000, 11:36 a.m. ]

Supplemental Notice to WSR 00-19-080.

Exempt from preproposal statement of inquiry under RCW 34.05.310(4).

Title of Rule: Requirements for industrial radiography and determination of prior dose.

Purpose: To correct the filing of WSR 00-19-080 and bring radiation protection regulations into conformance with the United States Nuclear Regulatory Commission rules on enforcement action for deliberate misconduct and make other corrections and housekeeping changes.

Statutory Authority for Adoption: RCW 70.98.050.

Statute Being Implemented: RCW 70.98.050.

Summary: The proposed rule clarifies that enforcement action may be taken where deliberate misconduct is involved (WAC 246-220-060) and corrects cross-referencing (WAC 246-235-105).

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Terry C. Frazee, Mailstop 47827, 7171 Cleanwater Lane, Tumwater, (360) 236-3221.

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

Rule is necessary because of federal law, 62 F.R. 63634, 63 F.R. 1890, and 63 F.R. 13773.

Explanation of Rule, its Purpose, and Anticipated Effects: This rule clarifies the categories of persons that are subject to department enforcement action based on deliberate misconduct. These changes are required for compatibility with the United States Nuclear Regulatory Commission. The anticipated effect of these changes is to bring our radioactive materials licensees into conformance with national standards.

Proposal Changes the Following Existing Rules: WAC 246-220-060 is amended to define categories of persons that may be subject to department enforcement action if engaged in deliberate misconduct that caused or would have caused, if not detected, a radioactive materials licensee, applicant, contractor or subcontractor to be in violation of any rule, regulation, license condition or department order; and WAC 246-235-105 is amended to correct cross references.

No small business economic impact statement has been prepared under chapter 19.85 RCW. This rule change is exempt from the small business impact statement requirement under RCW 19.85.025(3) because it adopts federal regulations without material change. This rule includes several federal rule changes for which "Regulatory Flexibility Certifications" were prepared stating that the "rule will not have a significant economic impact upon a substantial number of small entities."

Section 201, chapter 403, Laws of 1995, does not apply to this rule adoption. Under RCW 34.05.328 (5)(b)(iii) and (iv), RCW 34.05.328 does not apply to this rule adoption because this rule adopts federal regulations without material change or clarifies the language of a rule or otherwise makes housekeeping changes. This rule is for conformance with the United States Nuclear Regulatory Commission regulations and is mandatory under our agreement state status with the federal government.

Hearing Location: 7171 Cleanwater Lane, Building 5, Olympia, WA 98504, on November 21, 2000, at 10:00 a.m.

Assistance for Persons with Disabilities: Contact Terry Frazee by November 14, 2000, TDD (800) 833-6388, or fax (360) 236-2255.

Submit Written Comments to: Terry C. Frazee, fax (360) 236-2255, by November 21, 2000.

Date of Intended Adoption: November 21, 2000.

October 16, 2000

Mary C. Selecky

Secretary

OTS-4341.1


AMENDATORY SECTION(Amending Order 121, filed 12/27/90, effective 1/31/91)

WAC 246-220-060
Violations and deliberate misconduct.

(1) An injunction or other court order may be obtained prohibiting any violation of any provision of the act or any regulation or order issued thereunder.

(2) Any person who violates any provision of the act or any regulation or order issued thereunder may be guilty of a gross misdemeanor and upon conviction, may be punished by fine or imprisonment or both, as provided by law.

(3) Any person who knowingly provides to any licensee, applicant, contractor, or subcontractor, components, equipment, materials, or other goods or services, that relate to a licensee's or applicant's activities subject to these regulations, may be individually subject to department enforcement action for deliberate misconduct.

(4) For the purposes of subsection (3) of this section:

(a) Any:

(i) Radioactive materials licensee;

(ii) Applicant for a radioactive materials license;

(iii) Employee of a radioactive materials licensee or applicant; or

(iv) Contractor (including a supplier or consultant), subcontractor, or employee of a contractor or subcontractor of any radioactive materials licensee or applicant for a radioactive materials license;

(b) Who knowingly provides to any licensee, applicant, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's, or applicant's activities in these regulations;

(c) May not:

(i) Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee, or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the department; or

(ii) Deliberately submit to the department, a licensee, an applicant, or a licensee's or applicant's, contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the department.

(5) A person who violates subsections (3) and (4) of this section may be subject to enforcement action for deliberate misconduct described in subsections (1) and (2) of this section.

(6) For the purposes of subsections (3) and (4) of this section, deliberate misconduct by a person means an intentional act or omission that the person knows:

(a) Would cause a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the department; or

(b) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, applicant, contractor, or subcontractor.

[Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-220-060, filed 12/27/90, effective 1/31/91; Order 1095, 402-12-130, filed 2/6/76; Order 1, 402-12-130, filed 1/8/69; Rules (part), filed 10/26/66.]

OTS-4340.1


AMENDATORY SECTION(Amending WSR 98-13-037, filed 6/8/98, effective 7/9/98)

WAC 246-235-105
Manufacture, assembly or distribution of radioactive material exempt from regulation.

(1) Licensing the introduction of radioactive material into products in exempt concentrations. In addition to the requirements set forth in WAC 246-235-020, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under WAC 246-232-010 (((2)(a))) (1) will be issued if:

(a) The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioactive material in the product or material at the time of transfer; and

(b) The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in WAC 246-232-130, Schedule C, that reconstruction of the radioactive material in concentrations exceeding those in WAC 246-232-130, Schedule C, is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to a human being.

(c) Each person licensed under subsection (1) of this section shall file an annual report with the department which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product and material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made pursuant to subsection (1) of this section during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within thirty days thereafter.

(2) Licensing the distribution of certain radioactive material in exempt quantities.*


*Note: Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing source material or byproduct material whose subsequent possession, use, transfer and disposal by all other persons who are exempted from regulatory requirements may be obtained only from the United States Nuclear Regulatory Commission, Washington, D.C. 20555.

(a) An application for a specific license to distribute naturally occurring and accelerator-produced radioactive material (NARM) to persons exempted from these regulations pursuant to WAC 246-232-010 (2)(b) will be approved if:

(i) The radioactive material is not contained in any food, beverage, cosmetic, drug or other commodity designed for ingestion or inhalation by, or application to, a human being;

(ii) The radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

(iii) The applicant submits copies of prototype labels and brochures and the department approves such labels and brochures.

(b) The license issued under paragraph (2)(a) of this section is subject to the following conditions:

(i) No more than ten exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions shall not exceed unity.

(ii) Each exempt quantity shall be separately and individually packaged. No more than ten such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to WAC 246-232-010 (2)(b). The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.

(iii) The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which:

(A) Identifies the radionuclide and the quantity of radioactivity; and

(B) Bears the words "radioactive material."

(iv) In addition to the labeling information required by item (2)(b)(iii) of this section, the label affixed to the immediate container, or an accompanying brochure, shall:

(A) State that the contents are exempt from licensing state requirements;

(B) Bear the words "Radioactive material -- Not for human use -- Introduction into foods, beverages, cosmetics, drugs, or medicinals, or into products manufactured for commercial distribution is prohibited -- Exempt quantities should not be combined"; and

(C) Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage and disposal of the radioactive material.

(c) Each person licensed under paragraph (2)(a) of this section shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under WAC 246-232-010 (2)(b) or the equivalent regulations of a licensing state, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the department. Each report shall cover the year ending June 30, and shall be filed within thirty days thereafter. If no transfers of radioactive material have been made pursuant to subsection (2) of this section during the reporting period, the report shall so indicate.

(3) Licensing the incorporation of naturally occurring and accelerator-produced radioactive material into gas and aerosol detectors. An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under WAC ((246-232-010 (2)(c)(iii))) 246-232-012 will be approved if the application satisfies requirements equivalent to those contained in Section 32.26 of 10 CFR Part 32.

[Statutory Authority: RCW 70.98.050. 98-13-037, 246-235-105, filed 6/8/98, effective 7/9/98.]

Washington State Code Reviser's Office