WSR 17-09-071 PROPOSED RULES DEPARTMENT OF HEALTH [Filed April 18, 2017, 12:37 p.m.]
Original Notice.
Title of Rule and Other Identifying Information: WAC 246-221-055 Dose equivalent to an embryo/fetus, revise consistent with United States Nuclear Regulatory Commission (NRC) regulations; WAC 246-222-080 Inspections not warranted—Informal review, update reference to the department of labor and industries (L&I) rules; and WAC 246-225-030 General requirements—Plan review, update reference to national standard.
Hearing Location(s): Department of Health, Town Center 2, Room 145, 111 Israel Road S.E., Olympia, WA 98511, on May 23, 2017, at 11:00 a.m.
Date of Intended Adoption: May 24, 2017.
Submit Written Comments to: Vicki M. Bouvier, Department of Health, P.O. Box 47820, Olympia, WA 98504-7820, email https://fortress.wa.gov/doh/policyreview, by May 23, 2017.
Assistance for Persons with Disabilities: Contact Vicki M. Bouvier by May 16, 2017, TTY (800) 833-6388 or 711.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: This proposed rule making clarifies existing requirements and updates adopted radiation protection national standards, state rules, and federal regulations as follows: WAC 246-221-055 Dose equivalent to an embryo/fetus, revise standards consistent with NRC regulation; WAC 246-222-080 Inspections not warranted—Informal review, update reference to L&I rule; and WAC 246-225-030 General requirements—Plan review, update reference to the most current national shielding standard.
Reasons Supporting Proposal: The proposed rules protect public health by making them consistent with federal regulations, state rules, and national standards intended to protect workers and the public from sources of ionizing radiation.
Rule is necessary because of federal law, 10 C.F.R. 20.1208.
Name of Proponent: Department of health, governmental.
Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Curt Demaris, 111 Israel Road S.E., Tumwater, WA 98511, (360) 236-3223.
No small business economic impact statement has been prepared under chapter 19.85 RCW. Under RCW 19.85.025 and 34.05.310 (4)(c), a small business economic impact statement is not required for proposed rules that adopt or incorporate by reference, without material change, federal statutes or regulations, Washington state law, the rules of other Washington state agencies, or national consensus codes that generally establish industry standards.
A cost-benefit analysis is not required under RCW 34.05.328. The agency did not complete a cost-benefit analysis under RCW 34.05.328. RCW 34.05.328 (5)(b)(iii) exempts rules that adopt or incorporate by reference, without material change, federal statutes or regulations, Washington state law, the rules of other Washington state agencies, or national consensus codes that generally establish industry standards.
April 18, 2017
Clark Halvorson
Assistant Secretary
AMENDATORY SECTION (Amending WSR 01-05-110, filed 2/21/01, effective 3/24/01)
WAC 246-221-055 Dose equivalent to an embryo/fetus.
(1) The licensee or registrant shall ensure that the dose equivalent to an embryo/fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 5 mSv (0.5 rem).
(2) Once pregnancy has been declared, the licensee or registrant shall make every effort to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman in order to satisfy the limit in subsection (1) of this section.
(3) If by the time the woman declares pregnancy to the licensee or registrant, the dose equivalent to the embryo/fetus has exceeded ((4.5)) 5 mSv (((0.45)) 0.5 rem), or is within 0.50 mSv (0.05 rem) of this dose, the licensee or registrant shall be deemed to be in compliance with subsection (1) of this section if the additional dose equivalent to the embryo/fetus does not exceed 0.50 mSv (0.05 rem) during the remainder of the pregnancy.
(4) The dose equivalent to an embryo/fetus shall be taken as the sum of:
(a) The deep dose equivalent to the declared pregnant woman; and
(b) The dose equivalent to the embryo/fetus from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.
(5) The licensee or registrant shall maintain the records of dose equivalent to an embryo/fetus with the records of dose equivalent to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, shall also be kept on file, but may be maintained separately from the dose records.
AMENDATORY SECTION (Amending WSR 14-01-077, filed 12/16/13, effective 1/16/14)
WAC 246-222-080 Inspections not warranted—Informal review.
(1) If the department of health, office of radiation protection determines, with respect to a complaint under WAC 246-222-070 that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the office of radiation protection shall notify the complainant in writing of such determination.
(a) If the complaint resulted from activities concerning naturally occurring or accelerator produced radioactive materials or radiation producing machines: The complainant may obtain review of such determination by submitting a written statement of position to the Assistant Director, Division of Industrial Safety and Health, P.O. Box 4600, Olympia, Washington 98504-4600. Such request for informal review will be processed according to the provisions of WAC ((296-350-460)) 296-900-12015 and the provisions of the interagency agreement between the department of labor and industries and the department of health, office of radiation protection, if any.
(b) If the complaint resulted from activities concerning radioactive material: The complainant may obtain review of such determination by submitting a written statement of position with the Department of Health, Office of Radiation Protection, P.O. Box 47827, Olympia, Washington 98504-7827 (360-236-3300), who will provide the licensee or registrant with a copy of such statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The licensee or registrant may submit an opposing written statement of position with the department of health, office of radiation protection, who will provide the complainant with a copy of such statement by certified mail. Upon the request of the complainant, the department of health may hold an informal conference in which the complainant and the licensee or registrant may orally present their views. An informal conference may also be held at the request of the licensee or registrant, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. After considering all written or oral views presented, the department of health shall affirm, modify, or reverse the determination of the office of radiation protection and furnish the complainant and the licensee or registrant a written notification of the decision and the reason(s) therefore.
(2) If the office of radiation protection determines that an inspection is not warranted because the requirements of WAC 246-222-070(1) have not been met, it shall notify the complainant in writing of such determination. Such determination shall be without prejudice to the filing of a new complaint meeting the requirements of WAC 246-222-070(1).
AMENDATORY SECTION (Amending WSR 94-01-073, filed 12/9/93, effective 1/9/94)
WAC 246-225-030 General requirements—Plan review.
(1) Before construction, the floor plans and equipment arrangement of medical installations (new or modifications of existing installations) utilizing X rays for diagnostic or therapeutic purposes shall be submitted to:
(a) A qualified expert for determination of shielding requirements using National Council on Radiation Protection and Measurements (NCRP) Report No. ((49)) 147, available at the NCRP web site at https://www.ncrppublications.org, or equivalent; and
(b) The department for subsequent review.
Review shall not imply approval.
(2) The review of such plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits required under WAC 246-221-010, 246-221-050, and 246-221-060.
(3) Diagnostic veterinary, podiatric, and dental facilities shall be exempt from submitting shielding calculations and floor plans.
(4) In order for the department to provide an evaluation, technical advice, and official review of the shielding requirements for a medical radiation installation, a floor plan drawn to scale and the following data are required:
(a) The normal location of the X-ray tube, along with an indication of anode-cathode orientation to the cassette holders;
(b) The limits of the tube travel;
(c) The directions in which the tube is pointed;
(d) Window locations;
(e) The location of the control booth or operator's position;
(f) The exposure switch location;
(g) The position of the viewing window, if any;
(h) The composition and thickness of the walls;
(i) If more than one story, the height floor-to-floor;
(j) If more than one story, the composition and thickness of materials in the ceiling or floor;
(k) The make and model of the X-ray machine;
(l) The maximum kVp and mA;
(m) The types of examinations or treatments (for example, chest, spine, general X-ray, or therapy);
(n) The identification and occupancy of areas adjacent to the X-ray room;
(o) The anticipated X-ray workload expressed in number of patients and exposures per week including:
(i) Technique factors used, or milliampere-seconds or milliampere-minutes per week; and
(ii) Estimates of the percentage of the workload expected to occur for a particular beam direction.
(5) For new and modified installations only, the following are minimum design requirements for medical X-ray machine operator booths. These requirements do not apply to dental, podiatry, and veterinary installations. See subsections (6) and (7) of this section for dental panoramic and cephalometric requirements.
(a) The operator shall be allotted 0.7 sq. meters (7.5 sq. ft.) or more of unobstructed floor space in the X-ray booths.
(i) The 0.7 sq. meters (7.5 sq. ft.) of minimum space specified under subsection (5)(a) of this section shall be a geometric configuration where no dimension is less than 61.0 centimeters (2.0 ft.).
(ii) The allotted space shall exclude an encumbrance by the console, such as an overhang, cables, or other similar encroachment.
(iii) An extension of a straight line drawn between any point on the edge of the booth shielding and the nearest vertical edge of a vertical cassette holder, corner of the examination table, or any part of the tube housing assembly shall not impinge on the unobstructed space.
(iv) The booth walls shall be 2.1 meters (7.0 ft.) or more and shall be permanently fixed to the floor or other structure as may be necessary.
(v) When a door or moveable panel is used as the integral part of the booth structure, it must have a permissive device which will prevent an exposure when the door or panel is not closed.
(b) Switch placement. The operator's switch for the radiographic machine shall be fixed within the booth. The switch shall:
(i) Be at least 102 centimeters (forty inches) inside the protected area; and
(ii) Allow the operator to use the available viewing windows.
(c) Viewing system requirements.
(i) Each booth shall have at least one viewing device which shall:
(A) Be placed so the operator can view the patient during exposure; and
(B) Be placed so the operator can have full view of the entries into the room.
(ii) When the viewing system is a window, the following requirements also apply:
(A) The window shall have a visible area of 930 square centimeters (1.0 square foot) or more; and
(B) The glass shall have the same lead equivalence or more as that required in the booth's wall where the glass is mounted.
(iii) When the viewing system is by mirrors, the mirrors shall be located to accomplish the general requirements under subdivision (i) of this subsection.
(iv) When the viewing system is by electronic means (for example, TV):
(A) The camera shall be located to accomplish the general requirements under subdivision (i) of this subsection; and
(B) There shall be an alternate viewing system as a backup for electronic failure.
(d) New or modified facilities shall maintain a copy of the floor plan and shielding calculations required under subsection (1) of this section.
(6) Dimensions of primary beam shielding shall exceed the largest possible beam size by 30.5 centimeters (one foot) or more in every direction. Cephalometric primary beam shielding shall be deemed adequate if, for a maximum workload of twenty films a week, two-pound lead is installed (for occupied areas).
(7) A viewing device shall be present in dental panoramic and cephalometric X-ray installations, so the requirements of subsection (5)(c) of this section are met.
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