WSR 08-09-077

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed April 16, 2008, 7:19 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 07-20-037.

Title of Rule and Other Identifying Information: WAC 246-254-070, 246-254-080, 246-254-090, 246-254-100, 246-254-120, Radiation protection -- Fees.

Hearing Location(s): Department of Health, Town Center 3, Room 224, 243 Israel Road S.E., Tumwater, WA 98501, on May 30, 2008, at 1:30 p.m.

Date of Intended Adoption: May 30, 2008.

Submit Written Comments to: Arden Scroggs, Office of Radiation Protection, Radioactive Materials Section, P.O. Box 47827, Olympia, WA 98504-7827, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2255, by May 30, 2008.

Assistance for Persons with Disabilities: Contact Joy A. Redman by May 23, 2008, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The materials program is a fee-supported regulatory program which licenses and inspects approximately 550 facilities in Washington state under RCW 70.98.080. This proposed rule change increases licensing fees for those facilities by approximately 30% to meet the anticipated costs of the materials program including the addition of one inspector. The individual rate of increase per license ranges from 29.4 to 30%. Additionally, this rule making will revise the medical license fee terminology to reflect current terminology and regulatory references, and combine the current two health physics service provider fee categories into a single fee category.

Reasons Supporting Proposal: The department is authorized under RCW 43.20B.020 and 43.70.250 to charge fees that are sufficient to cover the cost of administering the program. The department is also required under RCW 43.70.110 to charge licensing fees to businesses possessing radioactive materials based on the cost of regulating the activity. Also, the regulations pertaining to medical use of radioactive material were recently revised to include new references and language, and the fee rule needs to be revised to reflect that language. This [These] proposed fees are authorized under SBH [SHB] 2687 consistent with Initiative 960.

Statutory Authority for Adoption: RCW 70.98.080, 43.20B.020, 43.70.110, and 43.70.250.

Statute Being Implemented: RCW 70.98.080, 43.20B.020, 43.70.110, and 43.70.250.

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

Name of Proponent: Department of health, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Arden Scroggs, 111 Israel Road S.W., Tumwater, WA, (360) 236-3221.

No small business economic impact statement has been prepared under chapter 19.85 RCW. Under RCW 19.85.025 and 34.05.310 (4)(f), a small business economic impact statement is not required for proposed rules that set or adjust fees or rates pursuant to legislative 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)(vi) exempts rules that set or adjust fees or rates pursuant to legislative standards.

April 16, 2008

Mary C. Selecky

Secretary

OTS-1066.7


AMENDATORY SECTION(Amending WSR 05-24-109, filed 12/7/05, effective 1/7/06)

WAC 246-254-070   Fees for specialized radioactive material licenses.   (1) Persons licensed or authorized to possess or use radioactive material in the following special categories shall forward annual fees to the department as follows:

(a) (($7,050)) $9,164 for operation of a single nuclear pharmacy.

(b) (($12,025)) $15,628 for operation of a single nuclear laundry.

(c) (($12,025)) $15,628 for a license authorizing a single facility to use more than one curie of unsealed radioactive material in the manufacture and distribution of radioactive products or devices containing radioactive material.

(d) (($4,215)) $5,476 for a license authorizing a single facility to use less than or equal to one curie of unsealed radioactive material or any quantity of previously sealed sources in the manufacture and distribution of products or devices containing radioactive material.

(e) (($1,085)) $1,408 for a license authorizing the receipt and redistribution from a single facility of manufactured products or devices containing radioactive material.

(f) (($8,065)) $10,484 for a license authorizing decontamination services operating from a single facility.

(g) (($3,815)) $4,956 for a license authorizing waste brokerage including the possession, temporary storage at a single facility, and over-packing only of radioactive waste.

(h) (($1,700 for a license authorizing equipment servicing involving:

(i) Incidental use of calibration sources;

(ii) Maintenance of equipment containing radioactive material; or

(iii) Possession of sealed sources for purpose of sales demonstration only.

(i) $3,175)) $2,208 for a license authorizing health physics services, leak testing, ((or)) calibration services, equipment servicing, or possession of sealed sources for purpose of sales demonstration only.

(((j) $1,995)) (i) $2,592 for a civil defense license.

(((k) $600)) (j) $780 for a license authorizing possession of special nuclear material as pacemakers or depleted uranium as shielding.

(2) Persons licensed or authorized to possess and use radioactive material in the following broad scope categories shall forward annual fees to the department as follows:

(a) (($23,860)) $31,016 for a license authorizing possession of atomic numbers three through eighty-three with maximum authorized possession of any single isotope greater than one curie.

(b) (($11,030)) $14,336 for a license authorizing possession of atomic numbers three through eighty-three with maximum authorized possession of any single isotope greater than 0.1 curie but less than or equal to one curie.

(c) (($8,865)) $11,520 for a license authorizing possession of atomic numbers three through eighty-three with maximum authorized possession less than or equal to 0.1 curie.

(3) Persons licensed or authorized to possess or use radioactive material which are not covered by any of the annual license fees described in WAC 246-254-070 through 246-254-100, shall pay fees as follows:

(a) An initial application fee of one thousand dollars;

(b) Billing at the rate of (($125)) $162 for each hour of direct staff time associated with issuing and maintaining the license and for the inspection of the license; and

(c) Any fees for additional services as described in WAC 246-254-120.

(d) The initial application fee will be considered a credit against billings for direct staff charges but is otherwise nonrefundable.

(4) Persons licensed or authorized to possess or use radioactive material in a facility for radioactive waste processing, including resource recovery, volume reduction, decontamination activities, or other waste treatment, but not permitting commercial on-site disposal, shall pay fees as follows:

(a) A nonrefundable initial application fee for a new license of sixteen thousand dollars which shall be credited to the applicant's quarterly billing described in (b) of this subsection; and

(b) Quarterly billings for actual direct and indirect costs incurred by the department including, but not limited to, license renewal, license amendments, compliance inspections, a resident inspector for time spent on the licensee's premises as deemed necessary by the department, laboratory and other support services, and travel costs associated with staff involved in the foregoing.

[Statutory Authority: RCW 70.98.080, 43.20B.020, 43.70.110, and 43.70.250. 05-24-109, 246-254-070, filed 12/7/05, effective 1/7/06. Statutory Authority: RCW 43.70.250. 04-12-124, 246-254-070, filed 6/2/04, effective 7/3/04. Statutory Authority: RCW 70.98.080, 43.70.250 and [43.70.]110. 03-14-034, 246-254-070, filed 6/23/03, effective 7/24/03. Statutory Authority: RCW 43.70.250, 43.270.040, and 2001 2nd sp.s. c 7 220. 02-04-025, 246-254-070, filed 1/24/02, effective 2/24/02. Statutory Authority: RCW 70.98.080. 01-14-046, 246-254-070, filed 6/29/01, effective 7/30/01. Statutory Authority: RCW 43.70.250. 00-02-016, 246-254-070, filed 12/27/99, effective 1/27/00; 99-12-022, 246-254-070, filed 5/24/99, effective 6/24/99. Statutory Authority: RCW 43.70.110. 98-11-067, 246-254-070, filed 5/19/98, effective 6/19/98. Statutory Authority: RCW 43.70.110, [43.70.]250 and chapter 70.98 RCW. 96-11-043, 246-254-070, filed 5/8/96, effective 6/28/96; 95-12-004, 246-254-070, filed 5/25/95, effective 6/25/95; 94-11-011 246-254-070, filed 5/5/94, effective 6/5/94; 93-13-019 (Order 372), 246-254-070, filed 6/8/93, effective 7/9/93. Statutory Authority: RCW 43.70.110. 91-22-027 (Order 208), 246-254-070, filed 10/29/91, effective 11/29/91.]


AMENDATORY SECTION(Amending WSR 05-24-109, filed 12/7/05, effective 1/7/06)

WAC 246-254-080   Fees for medical and veterinary radioactive material ((licenses)) use.   (1) ((Persons licensed or)) Licensees authorized ((to possess)) possession or use of radioactive material in the following medical or veterinary categories shall forward annual fees to the department as follows:

(a) (($5,960)) $7,748 for operation of a mobile nuclear medicine program from a single base of operation((.));

(b) (($4,345)) $5,648 for ((a license authorizing groups II and III of WAC 246-235-120 for diagnostic nuclear medicine at a single facility.)) the use of unsealed radioactive material for imaging and localization studies for which a written directive is not required as defined in WAC 246-240-157, at a single facility (diagnostic imaging and localization nuclear medicine);

(c) (($3,765)) $4,892 for ((a license authorizing groups IV and V of WAC 246-235-120 for medical therapy at a single facility.)) the use of unsealed radioactive material for which a written directive is required as defined in WAC 246-240-201 at a single facility (radiopharmaceutical therapy);

(d) (($6,000)) $7,800 for ((a license authorizing groups II or III and groups IV or V of WAC 246-235-120 for full diagnostic and therapy services at a single facility.)) the use of unsealed radioactive material for imaging and localization studies for which a written directive is not required as defined in WAC 246-240-157, the use of unsealed radioactive material for which a written directive is required as defined in WAC 246-240-201, and/or the use of sealed sources for manual brachytherapy as defined in WAC 246-240-251 at a single facility (combination diagnostic nuclear medicine and/or radiopharmaceutical therapy), and/or sealed source (manual or machine) therapy;

(e) (($3,225)) $4,192 for ((a license authorizing group VI of WAC 246-235-120 for brachytherapy at a single facility.)) the use of sealed sources for manual brachytherapy as defined in WAC 246-240-251 at a single facility (manual brachytherapy);

(f) (($1,995)) $2,592 for ((a license authorizing brachytherapy or gamma stereotactic therapy or teletherapy at a single facility.)) the use of sealed sources in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit, as defined in WAC 246-240-351, at a single facility (machine brachytherapy);

(g) (($3,030)) $3,936 for a license authorizing medical or veterinary possession of greater than two hundred millicuries total possession of radioactive material at a single facility((.));

(h) (($2,410)) $3,132 for a license authorizing medical or veterinary possession of greater than thirty millicuries but less than or equal to two hundred millicuries total possession of radioactive material at a single facility((.));

(i) (($1,765)) $2,292 for a license authorizing medical or veterinary possession of less than or equal to thirty millicuries total possession of radioactive material at a single facility((.));

(j) (($1,555)) $2,020 for ((a license authorizing group I as defined in WAC 246-235-120 or in vitro uses of radioactive material at a single facility.)) the use of unsealed radioactive material for uptake, dilution and/or excretion studies for which a written directive is not required, as defined in WAC 246-240-151, at a single facility (diagnostic uptake, dilution, and excretion nuclear medicine);

(k) (($970)) $1,260 for a license authorizing medical or veterinary possession of a sealed source for diagnostic use at a single facility.

(2) ((Persons with licenses authorizing multiple locations of use shall increase the annual fee by fifty percent for each additional location or base of operation.)) The fee for a license authorizing multiple locations shall be increased by fifty percent of the annual fee for each additional location.

[Statutory Authority: RCW 70.98.080, 43.20B.020, 43.70.110, and 43.70.250. 05-24-109, 246-254-080, filed 12/7/05, effective 1/7/06. Statutory Authority: RCW 43.70.250. 04-12-124, 246-254-080, filed 6/2/04, effective 7/3/04. Statutory Authority: RCW 70.98.080, 43.70.250 and [43.70.]110. 03-14-034, 246-254-080, filed 6/23/03, effective 7/24/03. Statutory Authority: RCW 43.70.250, 43.270.040, and 2001 2nd sp.s. c 7 220. 02-04-025, 246-254-080, filed 1/24/02, effective 2/24/02. Statutory Authority: RCW 70.98.080. 01-14-046, 246-254-080, filed 6/29/01, effective 7/30/01. Statutory Authority: RCW 43.70.250. 00-02-016, 246-254-080, filed 12/27/99, effective 1/27/00; 99-12-022, 246-254-080, filed 5/24/99, effective 6/24/99. Statutory Authority: RCW 43.70.110. 98-11-067, 246-254-080, filed 5/19/98, effective 6/19/98. Statutory Authority: RCW 43.70.110, [43.70.]250 and chapter 70.98 RCW. 96-11-043, 246-254-080, filed 5/8/96, effective 6/28/96; 95-12-004, 246-254-080, filed 5/25/95, effective 6/25/95; 94-11-011 246-254-080, filed 5/5/94, effective 6/5/94; 93-13-019 (Order 372), 246-254-080, filed 6/8/93, effective 7/9/93. Statutory Authority: RCW 43.70.110. 91-22-027 (Order 208), 246-254-080, filed 10/29/91, effective 11/29/91.]


AMENDATORY SECTION(Amending WSR 05-24-109, filed 12/7/05, effective 1/7/06)

WAC 246-254-090   Fees for industrial radioactive material licenses.   (1) Persons licensed or authorized to possess or use radioactive material in the following industrial categories shall forward annual fees to the department as follows:

(a) (($7,020)) $9,124 for a license authorizing the use of radiographic exposure devices in one or more permanent radiographic vaults in a single facility.

(b) (($9,410)) $12,232 for a license authorizing the use of radiographic exposure devices at temporary job sites but operating from a single storage facility.

(c) (($4,610)) $5,992 for a license authorizing well-logging activities including the use of radioactive tracers operating from a single storage facility.

(d) (($995)) $1,292 for a license authorizing possession of portable sealed sources including moisture/density gauges and excluding radiographic exposure devices operating from a single storage facility.

(e) (($1,085)) $1,408 for a license authorizing possession of any nonportable sealed source, including special nuclear material and excluding radioactive material used in a gas chromatograph at a single facility.

(f) (($685)) $888 for a license authorizing possession of gas chromatograph units containing radioactive material at a single facility.

(g) (($1,895)) $2,460 for a license authorizing possession of any self-shielded or pool type irradiator with sealed source total quantity greater than one hundred curies at a single facility.

(h) (($10,060)) $13,076 for a license authorizing possession of sealed sources for a walk-in type irradiator at a single facility.

(i) (($8,760)) $11,388 for a license authorizing possession of greater than one gram of unsealed special nuclear material or greater than five hundred kilograms of source material at a single facility.

(j) (($2,805)) $3,644 for a license authorizing possession of less than or equal to one gram of unsealed special nuclear material or five hundred kilograms of source material at a single facility.

(k) (($445)) $576 for a license authorizing possession of static elimination devices not covered by a general license.

(2) Persons with licenses authorizing multiple locations of permanent storage shall increase the annual fee by fifty percent for each additional location.

(3) Depleted uranium registrants required to file Form RHF-20 shall forward an annual fee of (($90)) $116 to the department.

(4) General licensees required to register in accordance with WAC 246-233-020 (3)(k) shall forward an annual fee of (($265)) $344 to the department.

[Statutory Authority: RCW 70.98.080, 43.20B.020, 43.70.110, and 43.70.250. 05-24-109, 246-254-090, filed 12/7/05, effective 1/7/06. Statutory Authority: RCW 43.70.250. 04-12-124, 246-254-090, filed 6/2/04, effective 7/3/04. Statutory Authority: RCW 70.98.050. 04-04-055, 246-254-090, filed 1/30/04, effective 3/1/04. Statutory Authority: RCW 70.98.080, 43.70.250 and [43.70.]110. 03-14-034, 246-254-090, filed 6/23/03, effective 7/24/03. Statutory Authority: RCW 43.70.250, 43.270.040, and 2001 2nd sp.s. c 7 220. 02-04-025, 246-254-090, filed 1/24/02, effective 2/24/02. Statutory Authority: RCW 70.98.080. 01-14-046, 246-254-090, filed 6/29/01, effective 7/30/01. Statutory Authority: RCW 43.70.250. 00-02-016, 246-254-090, filed 12/27/99, effective 1/27/00; 99-12-022, 246-254-090, filed 5/24/99, effective 6/24/99. Statutory Authority: RCW 43.70.110. 98-11-067, 246-254-090, filed 5/19/98, effective 6/19/98. Statutory Authority: RCW 43.70.110, [43.70.]250 and chapter 70.98 RCW. 96-11-043, 246-254-090, filed 5/8/96, effective 6/28/96; 95-12-004, 246-254-090, filed 5/25/95, effective 6/25/95; 94-11-011 246-254-090, filed 5/5/94, effective 6/5/94; 93-13-019 (Order 372), 246-254-090, filed 6/8/93, effective 7/9/93. Statutory Authority: RCW 43.70.110. 91-22-027 (Order 208), 246-254-090, filed 10/29/91, effective 11/29/91.]


AMENDATORY SECTION(Amending WSR 05-24-109, filed 12/7/05, effective 1/7/06)

WAC 246-254-100   Fees for laboratory radioactive material licenses.   (1) Persons licensed or authorized to possess or use unsealed radioactive material in the following laboratory categories shall forward annual fees to the department as follows:

(a) (($4,800)) $6,240 for a license authorizing possession at a single facility of unsealed sources in amounts greater than:

(i) One millicurie of I-125 or I-131; or

(ii) One hundred millicuries of H-3 or C-14; or

(iii) Ten millicuries of any single isotope.

(b) (($2,370)) $3,080 for a license authorizing possession at a single facility of unsealed sources in amounts:

(i) Greater than 0.1 millicurie and less than or equal to one millicurie of I-125 or I-131; or

(ii) Greater than ten millicuries and less than or equal to one hundred millicuries of H-3 or C-14; or

(iii) Greater than one millicurie and less than or equal to ten millicuries of any single isotope.

(c) (($1,995)) $2,592 for a license authorizing possession at a single facility of unsealed sources in amounts:

(i) Greater than 0.01 millicurie and less than or equal to 0.1 millicurie of I-125 or I-131; or

(ii) Greater than one millicurie and less than or equal to ten millicuries of H-3 or C-14; or

(iii) Greater than 0.1 millicurie and less than or equal to one millicurie of any other single isotope.

(d) (($685)) $888 for a license authorizing possession at a single facility of unsealed or sealed sources in amounts:

(i) Less than or equal to 0.01 millicurie of I-125 or I-131; or

(ii) Less than or equal to one millicurie of H-3 or C-14; or

(iii) Less than or equal to 0.1 millicurie of any other single isotope.

(e) (($920)) $1,196 for a license authorizing possession at a single facility of large quantities of naturally occurring radioactive material in total concentration not exceeding 0.002 microcurie per gram.

(2) Persons with licenses authorizing multiple locations of use shall increase the annual fee by fifty percent for each additional location.

(3) Persons registered to perform in vitro testing pursuant to Form RHF-15 shall forward an annual fee of (($90)) $116 to the department.

[Statutory Authority: RCW 70.98.080, 43.20B.020, 43.70.110, and 43.70.250. 05-24-109, 246-254-100, filed 12/7/05, effective 1/7/06. Statutory Authority: RCW 43.70.250. 04-12-124, 246-254-100, filed 6/2/04, effective 7/3/04. Statutory Authority: RCW 70.98.080, 43.70.250 and [43.70.]110. 03-14-034, 246-254-100, filed 6/23/03, effective 7/24/03. Statutory Authority: RCW 43.70.250, 43.270.040, and 2001 2nd sp.s. c 7 220. 02-04-025, 246-254-100, filed 1/24/02, effective 2/24/02. Statutory Authority: RCW 70.98.080. 01-14-046, 246-254-100, filed 6/29/01, effective 7/30/01. Statutory Authority: RCW 43.70.250. 00-02-016, 246-254-100, filed 12/27/99, effective 1/27/00; 99-12-022, 246-254-100, filed 5/24/99, effective 6/24/99. Statutory Authority: RCW 43.70.110. 98-11-067, 246-254-100, filed 5/19/98, effective 6/19/98. Statutory Authority: RCW 43.70.110, [43.70.]250 and chapter 70.98 RCW. 96-11-043, 246-254-100, filed 5/8/96, effective 6/28/96; 95-12-004, 246-254-100, filed 5/25/95, effective 6/25/95; 94-11-011 246-254-100, filed 5/5/94, effective 6/5/94; 93-13-019 (Order 372), 246-254-100, filed 6/8/93, effective 7/9/93. Statutory Authority: RCW 43.70.110. 91-22-027 (Order 208), 246-254-100, filed 10/29/91, effective 11/29/91.]


AMENDATORY SECTION(Amending WSR 05-24-109, filed 12/7/05, effective 1/7/06)

WAC 246-254-120   Fees for licensing and compliance actions.   (1) In addition to the fee for each radioactive material license as described under WAC 246-254-070, 246-254-080, 246-254-090, and 246-254-100, a licensee shall pay a service fee for each additional licensing and compliance action as follows:

(a) For a second follow-up inspection, and each follow-up inspection thereafter, a fee of (($125)) $162 per hour of direct staff time associated with the follow-up inspection, not to exceed (($1,250)) $1,625 per follow-up inspection. Hours are calculated in half-hour increments.

(b) For each environmental cleanup monitoring visit, a fee of (($125)) $162 per hour of direct staff time associated with the environmental cleanup monitoring visit, not to exceed (($3,125)) $4,063 per visit. Hours are calculated in half-hour increments.

(c) For each new license application, the fee of (($200)) $260 in addition to the required annual fee.

(d) For each sealed source and device evaluation, a fee of (($125)) $162 per hour of direct staff time associated with each sealed source and device evaluation, not to exceed (($3,750)) $4,875 per evaluation.

(e) For review of air emission and environmental programs and data collection and analysis of samples, and review of decommissioning activities by qualified staff in those work units, a fee of (($125)) $162 per hour of direct staff time associated with the review. The fee does not apply to reviews conducted by the radioactive materials section staff and does not apply unless the review time would result in a special service charge exceeding ten percent of the licensee's annual fee.

(f) For expedited licensing review, a fee of (($125)) $162 per hour of direct staff time associated with the review. This fee only applies when, by the mutual consent of licensee and affected staff, a licensing request is taken out of date order and processed by staff during nonwork hours and for which staff is paid overtime.

(2) The licensee or applicant shall pay any additional service fees at the time of application for a new license or within thirty days of the date of the billing for all other licensing and compliance actions.

(3) The department shall process an application only upon receipt of the new application fee and the annual fee.

(4) The department may take action to modify, suspend, or terminate the license or sealed source and device registration if the licensee fails to pay the fee for additional licensing and compliance actions billed by the department.

[Statutory Authority: RCW 70.98.080, 43.20B.020, 43.70.110, and 43.70.250. 05-24-109, 246-254-120, filed 12/7/05, effective 1/7/06. Statutory Authority: RCW 43.70.250. 04-12-124, 246-254-120, filed 6/2/04, effective 7/3/04. Statutory Authority: RCW 43.70.250, 43.270.040, and 2001 2nd sp.s. c 7 220. 02-04-025, 246-254-120, filed 1/24/02, effective 2/24/02. Statutory Authority: RCW 70.98.080. 01-14-046, 246-254-120, filed 6/29/01, effective 7/30/01. Statutory Authority: RCW 43.70.110, 43.70.250 and chapter 70.98 RCW. 95-12-004, 246-254-120, filed 5/25/95, effective 6/25/95; 94-11-011, 246-254-120, filed 5/5/94, effective 6/5/94; 93-13-019 (Order 372), 246-254-120, filed 6/8/93, effective 7/9/93. Statutory Authority: RCW 43.70.110. 91-22-027 (Order 208), 246-254-120, filed 10/29/91, effective 11/29/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as 246-254-120, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), 402-70-070, filed 12/11/86; 79-12-073 (Order 1459), 402-70-070, filed 11/30/79, effective 1/1/80.]

Washington State Code Reviser's Office