Pages 552 to 633 include ARC 2003B to ARC 2047B

Filed, Clarification of board’s conduct of
business; firm name; closing orders, 2.2(1),
2.3, 9.4, 9.7, 13.6(5), 15.10(2) ARC 2028B 624

Administrative rules review committee 542

Schedule for rule making 540

Publication procedures 541

Administrative rules on CD–ROM 541

Agency identification numbers 550

Notice, Iowa capital investment board -
administration; tax credit for investments in
qualifying businesses and community–based
seed capital funds, chs 1, 2 ARC 2042B 552

CITATION OF ADMINISTRATIVE RULES 549

Human Services Department[441]
Offset of county debts owed department—
organizational references and appeal
process, 14.1 to 14.6 Delay 634
Waiver services, 79.1(15)“d”(4) Delay 634

Filed Emergency, Issuance of practitioner’s
licenses and endorsements, rescind
14.1 to 14.34 ARC 2038B 614

Notice, Community college faculty planning,
21.3(4) ARC 2026B 556

Notice, Criteria for and approval of Iowa
teacher intern preparation programs, 77.4,
77.5 ARC 2025B 558

Filed, Charter schools, ch 68 ARC 2027B 624

Notice, Comity applicants experience
requirements; use of digital signatures;
NCEES examination development committee
participation as allowable professional
development activity, 1.1, 4.2(5), 6.1(9),
7.3(1) ARC 2029B 559

Filed, Interim rulings on petitions for
waivers and variances, 1.4 ARC 2024B 624

Filed, Requirements for a licensee requesting
additional examination, 4.3 ARC 2020B 625

Amended Notice, Air quality standards for
concentrated animal feeding operations;
ambient air quality standards, 20.2, 28.1
ARC 2043B 559

Amended Notice, Ambient air sampling
manual, 28.2 ARC 2045B 560

Delay, Offset of county debts owed department—
organizational references and appeal process,
14.1 to 14.6 634

Delay, Waiver services, 79.1(15)“d”(4) 634

Notice, Assessment fee for intermediate care
facilities for the mentally retarded, ch 36,
82.5(13) ARC 2035B 560

Notice, Payment of FIP benefits by direct
deposit or electronic funds transfer, 45.21,
45.24(1)“b”(3) ARC 2036B 561

Notice, Disproportionate share payments for
children’s hospitals, 79.1(5) ARC 2047B 561

Notice, Iowa senior living trust fund—administration
fee allowed for participating nursing facilities,
161.1 to 161.4 ARC 2037B 562

Filed Emergency After Notice, Applications for
FIP, food stamps, or Medicaid, 40.23, 65.1, 65.2,
65.4(2), 65.9, 65.19(2), 65.31, 65.36(4), 76.1
ARC 2032B 614

HUMAN SERVICES DEPARTMENT[441] (Cont’d)

Filed Emergency After Notice, Emergency
assistance program, 58.23 to 58.26, 58.28
to 58.31 ARC 2033B 614

Filed, Medicaid—reimbursement for root canal
treatments, 78.4(14) ARC 2021B 625

Filed Emergency, Disproportionate share
payments for children’s hospitals, 79.1(5)
ARC 2034B 615

Filed Emergency After Notice, Child care centers,
109.1 to 109.3, 109.6(6) ARC 2031B 619

Filed, Reimbursement rates for purchase of
service providers and rehabilitative treatment
and supportive services, 150.3(5)“p,”
185.112(1) ARC 2022B 626

Filed, Iowa hospital trust fund, ch 164
ARC 2023B 626

Objection, Farmers market potentially hazardous
food license, 30.3(4), 30.4(10) 634

Filed, Reporting requirements on licenses,
rescind ch 9 ARC 2017B 627

Notice, Wildlife habitat on private lands
promotion program, 22.1 to 22.4, 22.5(6),
22.7 to 22.9 ARC 2046B 563

Filed, Roofing and enclosure of private docks,
16.1, 16.3(5), 16.4(6), 16.5, 16.8(10), 16.9(3),
16.10 ARC 2044B 627

Filed Emergency After Notice, Wildlife importation,
transportation and disease monitoring, ch 104
ARC 2030B 619

Notice, Definition—unlicensed student, 3.1
ARC 2006B 564

Notice, NCLEX examination candidates—reduction
in time between authorization to test and first
possible test date, 3.4(3), 3.4(4) ARC 2005B 565

Filed, First professional degree; master’s degree,
2.1, 2.3(2), 2.6(2) ARC 2003B 628

Filed, Method for curriculum approval—
dependent adult and child abuse identification
and reporting course, 3.7(3)“e” ARC 2004B 628

Filed, IPERS, 21.4 to 21.6, 21.8, 21.19(1),
21.22(1), 21.27 ARC 2010B 629

Inspections and Appeals Department[481]
Farmers market potentially hazardous food
license, 30.3(4), 30.4(10) 634

Filed, Administrative and regulatory authority
for the board of mortuary science examiners,
ch 99 ARC 2019B 629

Filed, Administrative and regulatory authority
for the board of examiners for massage therapy,
ch 130 ARC 2018B 630

Notice, Practice of tattooing, 22.1 to 22.7
ARC 2016B 565

Notice, Radiation, amendments to chs 38 to 41,
45 ARC 2009B 567

Notice, Childhood lead poisoning prevention
program, ch 72 ARC 2007B 592

Filed, Newborn screening policy; maternal
screening policy; use of portion of metabolic
screening fee to fund special medical formula,
4.3, 4.4 ARC 2008B 630

Summarized list 545

Notice, Department authority to change statutory
thresholds for sales and withholding taxes; deadline
for director to send estimates of local option tax to
jurisdictions, amendments to chs 12, 13, 17, 18,
26, 46, 107, 108 ARC 2041B 594

Notice, Venture capital credits, 42.18, 52.21,
58.11 ARC 2040B 600

Filed, Deferment of income for start–up
companies, 52.1(10) ARC 2039B 631

Notice, Vehicle registration and certificate
of title—vehicle PIN numbers, 400.13, 400.16,
400.17, 400.51 ARC 2013B 601

Notice, Interstate registration and operation of
vehicles, ch 500 ARC 2014B 603

Notice, Interstate motor vehicle fuel permits,
amendments to ch 505 ARC 2015B 607

Filed, Improvements and maintenance on
primary road extensions, 150.1 to 150.4
ARC 2012B 632

Filed, Special permits for operation and
movement of vehicles and loads of excess
size and weight, 511.7 to 511.9, 511.12(2)
ARC 2011B 632

Notice 613

__________________________________

The Iowa Administrative Bulletin is published biweekly in pamphlet form pursuant to Iowa Code chapters 2B and 17A and contains Notices of Intended Action on rules, Filed and Filed Emergency rules by state agencies.
It also contains Proclamations and Executive Orders of the Governor which are general and permanent in nature; Economic Impact Statements to proposed rules and filed emergency rules; Objections filed by Administrative Rules Review Committee, Governor or the Attorney General; and Delay by the Committee of the effective date of filed rules; Regulatory Flexibility Analyses and Agenda for monthly Administrative Rules Review Committee meetings. Other “materials deemed fitting and proper by the Administrative Rules Review Committee” include summaries of Public Hearings, Attorney General Opinions and Supreme Court Decisions.
The Bulletin may also contain Public Funds Interest Rates [12C.6]; Workers’ Compensation Rate Filings [515A.6(7)]; Usury [535.2(3)“a”]; Agricultural Credit Corporation Maximum Loan Rates [535.12]; and Regional Banking—Notice of Application and Hearing [524.1905(2)].

PLEASE NOTE: Italics indicate new material added to existing rules; strike through letters indicate deleted material.

Subscriptions and Distribution Telephone: (515)242–5120

Fax: (515)242–5974

KATHLEEN K. BATES, Administrative Code Editor Telephone: (515)281–3355

STEPHANIE A. HOFF, Assistant Editor (515)281–8157

Fax: (515)281–4424

The Iowa Administrative Bulletin is sold as a separate publication and may be purchased by subscription or single copy. All subscriptions will expire on June 30 of each year. Subscriptions must be paid in advance and are prorated quarterly.

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Single copies may be purchased for $20.85 plus $1.25 sales tax.

The Iowa Administrative Code and Supplements are sold in complete sets and subscription basis only. All subscriptions for the Supplement (replacement pages) must be for the complete year and will expire on June 30 of each year.
Prices for the Iowa Administrative Code and its Supplements are as follows:

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PLEASE NOTE:

Rules will not be accepted after 12 o’clock noon on the Friday filing deadline days unless prior approval has been received from the Administrative Rules Coordinator’s office.

If the filing deadline falls on a legal holiday, submissions made on the following Monday will be accepted.



***Note change of filing deadline

TO: Administrative Rules Coordinators and Text Processors of State Agencies
FROM: Kathleen K. Bates, Iowa Administrative Code Editor
SUBJECT: Publication of Rules in Iowa Administrative Bulletin

The Administrative Code Division uses Interleaf 6 to publish the Iowa Administrative Bulletin and can import documents directly from most other word processing systems, including Microsoft Word, Word for Windows (Word 7 or earlier), and WordPerfect.

1. To facilitate the publication of rule–making documents, we request that you send your document(s) as an attachment(s) to an E–mail message, addressed to both of the following:

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Containing: Iowa Administrative Code (updated through December 2001)
Iowa Administrative Bulletins (July 2001 through December 2001)
Iowa Court Rules (effective February 15, 2002)

For free brochures and order forms contact:

Legislative Service Bureau
Attn: Ms. Stephanie Cox
State Capitol
Des Moines, Iowa 50319
Telephone: (515)281–3566 Fax: (515)281–8027
lsbinfo@legis.state.ia.us

The Administrative Rules Review Committee will hold its regular, statutory meeting on Tuesday, October 8, 2002, and Wednesday, October 9, 2002, at 9 a.m. in Room 116, State Capitol, Des Moines, Iowa. The following rules will be reviewed:

Regular statutory meetings are held the second Tuesday of each month at the seat of government as provided in Iowa Code section 17A.8. A special meeting may be called by the Chair at any place in the state and at any time.

To All Agencies:
The Administrative Rules Review Committee voted to request that Agencies comply with Iowa Code section 17A.4(1)“b” by allowing the opportunity for oral presentation (hearing) to be held at least twenty days after publication of Notice in the Iowa Administrative Bulletin.

CITATION of Administrative Rules

The Iowa Administrative Code shall be cited as (agency identification number) IAC
(chapter, rule, subrule, lettered paragraph, or numbered subparagraph).

441 IAC 79 (Chapter)

441 IAC 79.1(249A) (Rule)

441 IAC 79.1(1) (Subrule)

441 IAC 79.1(1)“a” (Paragraph)

441 IAC 79.1(1)“a”(1) (Subparagraph)

The Iowa Administrative Bulletin shall be cited as IAB (volume), (number), (publication
date), (page number), (ARC number).

IAB Vol. XII, No. 23 (5/16/90) p. 2050, ARC 872A

Due to reorganization of state government by 1986 Iowa Acts, chapter 1245, it was necessary to revise the agency identification numbering system, i.e., the bracketed number following the agency name.

“Umbrella” agencies and elected officials are set out below at the left–hand margin in CAPITAL letters.

Divisions (boards, commissions, etc.) are indented and set out in lowercase type under their statutory “umbrellas.”

Other autonomous agencies which were not included in the original reorganization legislation as “umbrella” agencies are included alphabetically in small capitals at the left–hand margin, e.g., BEEF INDUSTRY COUNCIL, IOWA[101].

The following list will be updated as changes occur:

AGRICULTURE AND LAND STEWARDSHIP DEPARTMENT[21]

Agricultural Development Authority[25]

Soil Conservation Division[27]

ATTORNEY GENERAL[61]

AUDITOR OF STATE[81]

CITIZENS’ AIDE[141]

CIVIL RIGHTS COMMISSION[161]

COMMERCE DEPARTMENT[181]

Alcoholic Beverages Division[185]

Banking Division[187]

Credit Union Division[189]

Insurance Division[191]

Professional Licensing and Regulation Division[193]

Accountancy Examining Board[193A]

Architectural Examining Board[193B]

Engineering and Land Surveying Examining Board[193C]

Landscape Architectural Examining Board[193D]

Real Estate Commission[193E]

Real Estate Appraiser Examining Board[193F]

Savings and Loan Division[197]

Utilities Division[199]

CORRECTIONS DEPARTMENT[201]

Parole Board[205]

CULTURAL AFFAIRS DEPARTMENT[221]

Arts Division[222]

Historical Division[223]

ECONOMIC DEVELOPMENT, IOWA DEPARTMENT OF[261]

City Development Board[263]

Iowa Finance Authority[265]

EDUCATION DEPARTMENT[281]

Educational Examiners Board[282]

College Student Aid Commission[283]

Higher Education Loan Authority[284]

Iowa Advance Funding Authority[285]

Libraries and Information Services Division[286]

Public Broadcasting Division[288]

School Budget Review Committee[289]

ELDER AFFAIRS DEPARTMENT[321]

EXECUTIVE COUNCIL[361]

GENERAL SERVICES DEPARTMENT[401]

HUMAN RIGHTS DEPARTMENT[421]

Community Action Agencies Division[427]

Criminal and Juvenile Justice Planning Division[428]

Deaf Services Division[429]

Persons With Disabilities Division[431]

Latino Affairs Division[433]

Status of African–Americans, Division on the[434]

Status of Women Division[435]

HUMAN SERVICES DEPARTMENT[441]

INFORMATION TECHNOLOGY DEPARTMENT[471]

INSPECTIONS AND APPEALS DEPARTMENT[481]

Employment Appeal Board[486]

Foster Care Review Board[489]

Racing and Gaming Commission[491]

State Public Defender[493]

LAW ENFORCEMENT ACADEMY[501]

MANAGEMENT DEPARTMENT[541]

Appeal Board, State[543]

City Finance Committee[545]

County Finance Committee[547]

NATURAL RESOURCES DEPARTMENT[561]

Energy and Geological Resources Division[565]

Environmental Protection Commission[567]

Natural Resource Commission[571]

Preserves, State Advisory Board for[575]

PERSONNEL DEPARTMENT[581]

PUBLIC DEFENSE DEPARTMENT[601]

Emergency Management Division[605]

Military Division[611]

PUBLIC EMPLOYMENT RELATIONS BOARD[621]

PUBLIC HEALTH DEPARTMENT[641]

Substance Abuse Commission[643]

Professional Licensure Division[645]

Dental Examiners Board[650]

Medical Examiners Board[653]

Nursing Board[655]

Pharmacy Examiners Board[657]

PUBLIC SAFETY DEPARTMENT[661]

REGENTS BOARD[681]

Archaeologist[685]

REVENUE AND FINANCE DEPARTMENT[701]

Lottery Division[705]

SECRETARY OF STATE[721]

TRANSPORTATION DEPARTMENT[761]

Railway Finance Authority[765]

TREASURER OF STATE[781]

WORKFORCE DEVELOPMENT DEPARTMENT[871]

Labor Services Division[875]

Workers’ Compensation Division[876]

Workforce Development Board and
Workforce Development Center Administration Division[877]

Pursuant to the authority of 2002 Iowa Acts, House File 2078, section 3, the Iowa Capital Investment Board hereby gives Notice of Intended Action to adopt Chapter 1, “Iowa Capital Investment Board – Administration,” and Chapter 2, “Tax Credit for Investments in Qualifying Businesses and Community–Based Seed Capital Funds,” Iowa Administrative Code.

These rules are proposed because of 2002 Iowa Acts, House Files 2078, 2271 and 2586.

Item 1 adopts Chapter 1 to set forth the administrative duties of the Iowa Capital Investment Board.

Item 2 adopts Chapter 2 to provide for an investment tax credit administered by the Iowa Capital Investment Board for investments in qualifying businesses and community–based seed capital funds.

These rules are being filed by the Department of Revenue and Finance on behalf of the Iowa Capital Investment Board pursuant to an Administrative Services Agreement between the Department and the Board.

The proposed rules will not necessitate additional expenditures by political subdivisions or agencies and entities which contract with political subdivisions.

Any person who believes that the application of the discretionary provisions of these rules would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any.

The Board has determined that these proposed rules may have an impact on small business. The Board has considered the factors listed in Iowa Code section 17A.4A. The Board will issue a regulatory analysis as provided in Iowa Code section 17A.4A if a written request is filed by delivery or by mailing postmarked no later than November 4, 2002, to the Iowa Capital Investment Board, in care of the Policy Section, Compliance Division, Department of Revenue and Finance, Hoover State Office Building, P.O. Box 10457, Des Moines, Iowa 50306. The request may be made by the Administrative Rules Review Committee, the Administrative Rules Coordinator, at least 25 persons signing that request who each qualify as a small business or an organization representing at least 25 such persons.

Any interested person may make written suggestions or comments on these proposed rules on or before November 1, 2002. Such written comments should be directed to the Iowa Capital Investment Board, in care of the Policy Section, Compliance Division, Department of Revenue and Finance, Hoover State Office Building, P.O. Box 10457, Des Moines, Iowa 50306.

Persons who want to convey their views orally should contact the Board, in care of the Policy Section, Compliance Division, Department of Revenue and Finance, at (515)281– 8036 or at the Department of Revenue and Finance offices on the fourth floor of the Hoover State Office Building.

Requests for a public hearing must be received by October 25, 2002.

These rules are intended to implement Iowa Code chapter 15E as amended by 2002 Iowa Acts, House Files 2078, 2271 and 2586.

The following rules are proposed.

ITEM 1. Adopt the following new chapter:

CHAPTER 1
IOWA CAPITAL INVESTMENT BOARD –
ADMINISTRATION

123—1.1(15E) Mission of the board. The Iowa capital investment board (board) was established by an Act of the general assembly (2002 Iowa Acts, House File 2078). The Iowa capital investment board is created as a state governmental board. The purpose of the board shall be to mobilize venture equity capital for investment that will result in a significant potential to create jobs and to diversify and stabilize the economy of the state of Iowa.

123—1.2(15E) Membership of the board. The Iowa capital investment board shall consist of five voting members and two nonvoting advisory members. The five voting members shall be appointed by the governor and subject to confirmation by the senate. The five voting members shall be appointed to five–year staggered terms that shall be structured to allow the term of one member to expire each year.

One nonvoting member shall be appointed by the majority leader of the senate, and one nonvoting member shall be appointed by the speaker of the house. The nonvoting members shall be appointed for two–year terms which shall expire upon the convening of a new general assembly. Vacancies shall be filled in the same manner as the appointment of the original members.

123—1.3(15E) Powers of the board. The board shall have the power to engage consultants, expend funds, invest funds, contract, bond or insure against loss, or perform any other act necessary to carry out its purpose. However, the board shall not hire employees.

123—1.4(15E) Correspondence and communications. The office of the Iowa capital investment board is maintained in the office of the department of revenue and finance. Correspondence and communications to the board shall be directed in care of the Iowa Department of Revenue and Finance, Hoover State Office Building, Des Moines, Iowa 50319.

123—1.5(15E) Meetings of the board. Meetings of the board are subject to the open meetings provisions of Iowa Code section 21.3.

123—1.6(15E) Duties of the board. The primary duties of the board include the following:

1.6(1) To develop a system for issuance, registration and authorization of tax credits for investments in qualifying businesses and community–based seed capital funds as provided in 2002 Iowa Acts, House File 2271, section 3.

1.6(2) To establish criteria and procedures for the issuance, transfer and redemption of contingent tax credits for investments made to the Iowa fund of funds as provided in 2002 Iowa Acts, House File 2078, section 6.

1.6(3) To establish a system for the issuance and redemption of tax credits for investments in venture capital funds as provided in 2002 Iowa Acts, House File 2586, section 1.

1.6(4) On or before December 31 of the calendar year following the end of the immediately preceding fiscal year, to publish and present to the governor and the general assembly an annual report on the activities conducted pursuant to rule 123—2.1(15E). This report shall include a listing of eligible qualifying businesses and community–based seed capital funds and the number of tax credit certificates and the amount of tax credits issued.

These rules are intended to implement Iowa Code chapter 15E as amended by 2002 Iowa Acts, House Files 2078, 2271 and 2586.

ITEM 2. Adopt the following new chapter:

CHAPTER 2
TAX CREDIT FOR INVESTMENTS IN QUALIFYING
BUSINESSES AND COMMUNITY–BASED
SEED CAPITAL FUNDS

123—2.1(15E) Tax credit for investments in qualifying businesses and community–based seed capital funds. For tax years beginning on or after January 1, 2002, a taxpayer may claim a tax credit against the taxpayer’s tax liability for personal net income tax imposed under Iowa Code chapter 422, division II, for a portion of the taxpayer’s equity investment in a qualifying business. For tax years beginning on or after January 1, 2002, a taxpayer may claim a credit against the taxpayer’s tax liability for personal net income tax imposed under Iowa Code chapter 422, division II, business tax on corporations imposed under Iowa Code chapter 422, division III, taxation of financial institutions imposed under Iowa Code chapter 422, division V, insurance companies tax imposed under Iowa Code chapter 432 or taxation of credit unions imposed under Iowa Code section 533.24, for a portion of a taxpayer’s equity investment in a community–based seed capital fund. Only natural persons shall be eligible for the investment tax credit provided for an investment in a qualifying business. Natural persons and various types of legal entities including, but not limited to, corporations, limited liability companies, partnerships (both general and limited), trusts and estates shall be eligible for the investment tax credit provided for an investment in a community–based seed capital fund. If the taxpayer that is entitled to an investment tax credit for an investment in a community–based seed capital fund is a pass–through entity electing to have its income taxed directly to its individual owners, such as a partnership, limited liability company, S corporation, estate or trust, the pass–through entity shall allocate the allowable credit to each of the individual owners of the entity on the basis of each owner’s pro rata share of the earnings of the entity, and the individual owners may claim their respective credits on their individual income tax returns. An individual shall not separately claim a tax credit for an investment in a qualifying business for any tax credit allocated to such individual by a pass–through entity as described in the immediately preceding sentence.

123—2.2(15E) Definitions. The following definitions are applicable to this chapter:

“Affiliate” means a spouse, child, or sibling of an investor or a corporation, partnership, or trust in which an investor has a controlling equity interest or in which an investor exercises management control. For purposes of these rules, “controlling equity interest” means ownership of more than 50 percent of the outstanding equity interests of a corporation, partnership, limited liability company or trust. “Management control” means holding more than 50 percent voting power on any board of directors or trustees, any management committee or any other group managing a corporation, partnership, limited liability company or trust.

“Board” means the Iowa capital investment board created under 2002 Iowa Acts, House File 2078, section 3.

“Community–based seed capital fund” means a fund that meets the following criteria:

1. Is organized as a limited partnership or limited liability company;

2. Has, on or after January 1, 2002, a total of both capital commitments from investors and investments in qualifying businesses of at least $500,000, but not more than $3 million; and

3. Has no fewer than ten individual investors who are not affiliates, with no single investor and affiliates of that investor together owning a total of more than 25 percent of the ownership interests outstanding in the fund.

“Investor” means an individual making a cash investment in a qualifying business or a person making a cash investment in a community–based seed capital fund. “Investor” does not include a person who is a current or previous owner, member, partner (limited or general) or shareholder in a qualifying business.

“Near equity” means debt that may be converted to equity at the option of the debt holder, and royalty agreements.

“Qualifying business” means a business that meets the following criteria:

1. The principal business operations of the business are located in the state of Iowa;

2. The business has been in operation for 3 years or less from the date of the investment for which a credit is claimed;

3. The business has an owner who has successfully completed one of the following:

• An entrepreneurial venture development curriculum, such as programs developed by a John Pappajohn Entrepreneurial Center, or a holistic training program recognized by the Iowa department of economic development which generally encompasses the following areas: entrepreneurial training, management team development, intellectual property management, market research and analysis, sales and distribution development, financial planning and management and strategic planning;

• Three years of relevant business experience;

• A four–year college degree in business management, business administration or a related field;

• Other training or experience sufficient to increase the probability of success of the qualifying business;

4. The business is not a business engaged primarily in retail sales, real estate or the provision of health care or other professional services;

5. The business shall not have a net worth that exceeds$3 million at the date of the investment for which the credit is claimed; and

6. Within 24 months from the first date on which the equity investments qualifying for investment tax credits have been made, the business shall have secured total equity or near equity financing equal to at least $250,000.

123—2.3(15E) Taxpayers eligible for the investment tax credit. A taxpayer who is a natural person and an investor in a qualifying business or community–based seed capital fund is eligible to apply to the board for an investment tax credit applicable against such taxpayer’s personal net income tax liability imposed under Iowa Code chapter 422, division II. A taxpayer that is a legal entity, such as a corporation, limited liability company, partnership (general or limited), trust or estate, and is an investor in a community–based seed capital fund is eligible to apply to the board for an investment tax credit applicable against such taxpayer’s tax liability under the business tax on corporations imposed under Iowa Code chapter 422, division III, the taxation of financial institutions imposed under Iowa Code chapter 422, division V, the insurance companies tax imposed under Iowa Code chapter 432 or the taxation of credit unions imposed under Iowa Code section 533.24. The taxpayer’s investment must be made in the form of cash to purchase equity in a qualifying business or community–based seed capital fund.

123—2.4(15E) Application for the investment tax credit. A taxpayer that desires to receive an investment tax credit for an equity investment in a qualifying business or community–based seed capital fund must submit an application to the board for approval and provide such other information and documentation as may be requested by the board. Application forms for the investment tax credit may be obtained by contacting the Iowa capital investment board at the Iowa Department of Revenue and Finance, 1305 E. Walnut Street, Hoover State Office Building, Des Moines, Iowa 50319. The telephone number is (515)281–3204. Application forms may also be obtained by contacting a small business development center in the applicant’s geographic location. The board shall coordinate with small business development centers throughout the state to provide uniform application forms to small business development centers and to disseminate information regarding the investment tax credits. The board shall provide a summary of the investment tax credits to small business development centers by either supplying the small business development centers with a copy of these rules or delivering substantially similar information in any other format approved by the board. The board shall make itself accessible to small business development centers for assistance with questions concerning completion of applications or any other questions pertaining to the investment tax credits. Applications shall be submitted to the board in care of the department of revenue and finance at the address identified above. Applications shall be date– and time–stamped by the department of revenue and finance in the order in which such applications are received. Applications for the investment tax credit shall be accepted by the board until March 31 of the year following the calendar year in which the taxpayer’s equity investment was made.

EXAMPLE 1: A taxpayer makes an equity investment in a qualifying business on December 31, 2002. The taxpayer has until March 31, 2003, to apply to the board for an investment tax credit.

EXAMPLE 2: A taxpayer makes an equity investment in a qualifying business on July 1, 2003. The taxpayer has until March 31, 2004, to apply to the board for an investment tax credit.

2.5(1) Qualifying businesses. Within 120 days from the first date on which the equity investments qualifying for investment tax credits have been made (or, for investments made during the 2002 calendar year, by the later of 120 days from the first date on which the investments have been made or March 31, 2003), a qualifying business shall provide to the board the following information as a prerequisite to the board’s issuance of any investment tax credits to investors in such qualifying business:

a. A signed statement, from an officer, director, manager, member, or general partner of the qualifying business, that contains a description of the general nature of its business operations, the location of the principal business operations, the date on which the business was formed, and the date on which the business commenced operations;

b. A balance sheet, certified by the chief executive officer and the chief financial officer of the qualifying business, that reflects the qualifying business’s assets, liabilities and owners’ equity as of the close of the most recent month or quarter;

c. A signed statement, from an owner of the business, that describes the manner in which such owner satisfies one of the training requirements set forth in the definition of a qualifying business under rule 123—2.2(15E);

d. A signed statement, from an officer, director, manager, member or general partner of the qualifying business, that states the names, addresses, taxpayer identification numbers, shares or equity interests issued, consideration paid for the shares or equity interests, and the amounts of any tax credits, of all shareholders or equity–holders who may initially qualify for the tax credits, and the earliest year in which the tax credits may be redeemed. The statement shall contain a commitment by the qualifying business to amend its statement as may be necessary from time to time to reflect new equity interests or transfers in equity among current equity–holders or as any other information on the list may change; and

e. A certificate of existence of a business plan for the qualifying business which details the business’s growth strategy, management team, production/management plan, marketing plan, financial plan and other standard elements of a business plan.

Upon the board’s receipt of the information and documentation necessary to demonstrate satisfaction of the criteria set forth herein, the board shall, within a reasonable period of time, determine whether a business is a qualifying business. If the board verifies that the business is a qualifying business, the board shall register the qualifying business on a registry of such qualifying businesses. The board shall maintain the registry and use it to authorize the issuance of further investment tax credits to taxpayers who make equity investments in qualifying businesses registered with the board. The board shall issue written notification to the qualifying business and the applicant that such business has been registered as a qualifying business with the board for the purpose of issuing investment tax credits but that such registration is subject to removal and rescission under rule 123—2.9(15E) for any failure of the business to continuously satisfy the requirements necessary for verification and registration as a qualifying business.

2.5(2) Community–based seed capital funds. Within 120 days from the first date on which the equity investments qualifying for investment tax credits have been made (or, for investments made during the 2002 calendar year, by the later of 120 days from the first date on which the investments have been made or March 31, 2003), a community–based seed capital fund shall provide to the board the following information as a prerequisite to the board’s issuance of investment tax credits to investors in such community–based seed capital fund:

a. A copy of the fund’s certificate of limited partnership, limited partnership agreement, articles of organization or operating agreement or both certified by the chief executive officer of the community–based seed capital fund.

b. A signed statement, from an officer, director, manager, member or general partner of the fund, that states the total amount of capital contributions or capital commitments from investors and the total number of individual investors that are not affiliates and the ownership interest of each individual investor in the fund.

c. A signed statement, from an officer, director, manager, member or general partner of the fund, that states the names, addresses, taxpayer identification numbers, equity interests issued, consideration paid for the interests and the amounts of any tax credits, of all limited partners or members that may initially qualify for the tax credits, and the earliest year in which the tax credits may be redeemed. The statement shall also contain a commitment by the fund to amend its statement as may be necessary from time to time to reflect new equity interests or transfers in equity among current equity–holders or as any other information on the list may change.

Upon the board’s receipt of the information and documentation necessary to demonstrate a community–based seed capital fund’s satisfaction of the criteria set forth herein, the board shall, within a reasonable period of time, determine whether a fund is a community–based seed capital fund. If the board verifies that the fund is a community–based seed capital fund, the board shall register the community–based seed capital fund on a registry of such community–based seed capital funds. The board shall maintain the registry and use it to authorize the issuance of further investment tax credits to taxpayers that make equity investments in thecommunity–based seed capital funds registered with the board. The board shall issue written notification to thecommunity–based seed capital fund and the applicant that such fund has been registered as a community–based seed capital fund with the board for the purpose of issuing investment tax credits but that such registration is subject to removal and rescission under rule 123—2.9(15E) for any failure of the community–based seed capital fund to continuously satisfy the requirements necessary for verification and registration as a community–based seed capital fund.

123—2.6(15E) Issuance and distribution of investment tax credits. Upon verification and registration by the board of a qualifying business or community–based seed capital fund and approval of the taxpayer’s application, the board shall issue a tax credit certificate to the applicant, provided, however, that such tax credit certificate shall be subject to rescission by the board pursuant to rule 123—2.9(15E). The tax credit certificate shall be in a form approved by the board and shall contain the taxpayer’s name, address, and tax identification number, the amount of credit, the name of the qualifying business or community–based seed capital fund, the year in which the credit may be redeemed and any other information that may be required by the department of revenue and finance. In addition, the tax credit certificate shall contain the following statement:

The Iowa Capital Investment Board has not recommended or approved this investment or passed on the merits or risks of such investment. Investors should rely solely on their own investigation and analysis and seek investment, financial, legal and tax advice before making their own decision regarding investment in this enterprise.

A tax credit shall equal 20 percent of the taxpayer’s equity investment in a qualifying business or community–based seed capital fund. The maximum amount of a tax credit for an investment by an investor in any one qualifying business shall be $50,000. Each year, an investor and all affiliates of the investor shall not claim tax credits under this rule for more than five different investments in five different qualifying businesses. An investor in a community–based seed capital fund shall receive a tax credit pursuant to this rule only for the investor’s investment in the community–based seed capital fund and shall not receive any additional tax credit for the investor’s share of investments in a qualifying business made by the community–based seed capital fund. However, an investor in a community–based seed capital fund may receive a tax credit under this rule with respect to a separate direct investment made by the investor in the same qualifying business in which the community–based seed capital fund invests.

The aggregate amount of tax credits issued pursuant to this rule shall not exceed a total of $10 million. The total amount of tax credits issued during the fiscal year beginning July 1, 2002, shall not exceed $3 million. The total amount of tax credits issued during the fiscal year beginning July 1, 2003, shall not exceed $3 million. The total amount of tax credits issued during the fiscal year beginning July 1, 2004, shall not exceed $4 million. If, during any fiscal year during which tax credits are to be issued under this rule, applications are approved for more than the amount of credits authorized by 2002 Iowa Acts, House File 2271, section 3(4), the applicants shall receive tax credit certificates on a first–come, first–served basis, until the amount of credits authorized for issuance has been exhausted. Any tax credits approved but unissued shall be carried over to the next fiscal year, and the board shall, during the next fiscal year, give priority to applicants’ tax credits carried over from a prior fiscal year by(1) issuing tax credit certificates to the taxpayers for such carryover tax credits before issuing any new tax credits; and (2) applying the aggregate amount of the credits carried over against the total amount of tax credits to be issued during such fiscal year before approving or issuing new tax credits.

123—2.7(15E) Claiming the tax credits. A taxpayer shall not claim the tax credit prior to the third tax year following the tax year in which the investment is made. An investment shall be deemed to have been made on the same date as the date of acquisition of the equity interest as determined by the Internal Revenue Code. An investment made prior to January 1, 2002, shall not qualify for a tax credit under this rule. A tax credit shall not be redeemed during any tax year beginning prior to January 1, 2005. A tax credit shall not be transferable to any other taxpayer. Any tax credit in excess of the taxpayer’s liability for the tax year may be credited to the tax liability for the following five years or until depleted, whichever is earlier. Notwithstanding the foregoing, any tax credit carried over pursuant to rule 123—2.6(15E) and issued for the tax year immediately following the tax year in which the investment was made may be claimed by the taxpayer and credited to the taxpayer’s tax liability for the third tax year following the tax year in which the tax credit is issued. A tax credit shall not be carried back to a tax year prior to the tax year in which the taxpayer redeems the tax credit.

123—2.8(15E) Notification to the department of revenue and finance. Upon the issuance and distribution of investment tax credits for each tax year, the board shall notify the department of revenue and finance by providing copies of the tax credit certificates issued for such tax year to the department of revenue and finance. Such notification shall also include, but not be limited to, the aggregate number and amount of tax credits issued for such tax year.

123—2.9(15E) Rescinding the tax credits. Within 24 months from the first date on which the equity investments qualifying for investment tax credits have been made, a qualifying business shall provide to the board information and documentation sufficient to demonstrate that the business has secured total equity or near equity financing equal to at least $250,000. Examples of sufficient information and documentation include, but are not limited to, corporate, partnership or limited liability company–certified resolutions setting forth the names of individuals or entities making capital contributions and the amounts of such capital contributions or certified corporate, partnership, or limited liability company minutes reflecting the names of individuals or entities making capital contributions and the amounts of such capital contributions. On or by the last day of the 24–month period described herein, a qualifying business shall certify to the board, by a statement signed by an officer, director, member, manager, or general partner of the qualifying business, that it has secured the requisite amount of equity financing required by this rule within the time period prescribed by this rule and shall recertify to the board that the qualifying business continues to meet the requirements set forth in 123—subrule 2.5(1). In the event that a qualifying business fails to meet or maintain any requirement set forth in this rule, including, without limitation, timely filing of the certifications described in the preceding sentence of this rule, the board shall rescind any tax credit certificates issued to those taxpayers and shall notify the department of revenue and finance that it has done so, and the tax credit certificates shall be null and void. In addition, the board shall remove such qualifying business from its registry and shall issue written notification of such removal to the qualifying business and the applicants.

A community–based seed capital fund shall have invested at least 33 percent of its invested capital in no fewer than two separate qualifying businesses on or by the last day of the 36–month period that commences with the fund’s investing activities. On or by the last day of the 36–month perioddescribed under this rule, a community–based seed capital fund shall certify to the board, by a statement signed by an officer, director, member, manager, or general partner of the community–based seed capital fund, that it has met the requirements of this rule, within the time period prescribed by this rule and shall recertify to the board that the community–based seed capital fund continues to meet the require–ments set forth in 123—subrule 2.5(2). In the event that acommunity–based seed capital fund fails to meet or maintain any requirement set forth in this rule, including, without limitation, timely filing of the certifications described in the preceding sentence of this rule, the board shall rescind any tax credit certificates issued to limited partners or members and shall notify the department of revenue and finance that it has done so, and the tax credit certificates shall be null and void. In addition, the board shall remove such community–based seed capital fund from its registry and shall issue written notification of such removal to the community–based seed capital fund and the applicants. Notwithstanding the foregoing, a community–based seed capital fund may apply to the board for a one–year waiver from the requirements of this rule. The board shall, upon review of a community–based seed capital fund’s application for waiver, exercise reasonable discretion in granting or denying such waiver. In the event that the board grants to a community–based seed capital fund a one–year waiver from the requirements of this rule, the board shall defer any rescission of the tax credit certificates until the expiration of such one–year waiver period. If thecommunity–based seed capital fund meets the requirements of this rule by the expiration of such one–year waiver period, the tax credit certificates shall not be rescinded, but the tax credit certificates shall be rescinded at the end of such one–year waiver period if such requirements have not been met.

In the event a taxpayer has claimed an investment tax credit for an investment in a qualifying business under 2002 Iowa Acts, House File 2271, section 3(1)“a,” or for aninvestment in a community–based seed capital fund under 2002 Iowa Acts, House File 2271, section 3(1)“b,” and such tax credit has been rescinded under the provisions of this rule, the department of revenue and finance shall assess a deficiency against the taxpayer for the tax credit claimed upon receipt of written notice of the rescission of such tax credit by the board.

123—2.10(15E) Additional information. The board retains the authority to request additional information and documentation from a qualifying business or community–based seed capital fund regarding the operations, job creation and economic impact of such qualifying business or community–based seed capital fund, and the board may use such information in preparing and publishing any reports to be provided to the governor and the general assembly.

These rules are intended to implement Iowa Code chapter 15E as amended by 2002 Iowa Acts, House File 2271.

Pursuant to the authority of Iowa Code section 256.7(5), the State Board of Education hereby gives Notice of Intended Action to amend Chapter 21, “Community Colleges,” Iowa Administrative Code.

The proposed amendment updates the rules governing community college faculty planning in accordance with 2002 Iowa Acts, House File 2394. House File 2394 eliminates the state licensure requirement for community college faculty in lieu of each college developing a faculty plan to manage faculty qualifications and professional development, as of July 1, 2003. The proposed amendment provides the statutory requirements for a quality faculty plan, additional planning recommendations for the colleges to consider when adopting a plan, and the process that the Department of Education will use to review each plan.

Any interested person may submit oral or written comments on or before Tuesday, October 29, 2002, by addressing them to Beverly Bunker, Administrative Consultant, Iowa Department of Education, Grimes State Office Building, Des Moines, Iowa 50319–0146; telephone (515)281–3615;E–mail beverly.bunker@ed.state.ia.us.

A public hearing will be held on Tuesday, October 29, 2002, from 2:30 to 3:30 p.m. over the Iowa Communications Network. The following sites will be available for persons to attend the public hearing.

The origination site is Department of Education, Grimes State Office Building, 2nd Floor, Des Moines, Iowa 50319.

Additional sites are:

Arrowhead Area Education Agency

330 Avenue M

Library Building, Room Lib 204

Fort Dodge, Iowa

Kirkwood Community College

6301 Kirkwood Blvd.

Building 32B, Kirkwood Farm, Room 32B

Cedar Rapids, Iowa

Iowa Western Community College

2700 College Road

Looft Hall

Council Bluffs, Iowa

This amendment is intended to implement 2002 Iowa Acts, House File 2394.

The following amendment is proposed.

Rescind subrule 21.3(4) and adopt new subrule 21.3(4) as follows:

21.3(4) Quality faculty plan. By October 1, 2002, each community college must establish a quality faculty committee consisting of instructors and administrators to develop a plan for hiring and developing quality faculty. The committee must have equal representatives of arts and science and career and technical faculty with no more than a simple majority of members of the same gender. Faculty must be appointed by the certified employee organization representing faculty, if any, and administrators must be appointed by the college’s administration. If no faculty–certified employee organization representing faculty exists, the faculty will be appointed by administration pursuant to Iowa Code subsection 260C.48(4). The committee must submit the plan to the board of directors for consideration, approval and submittal to the department of education.

a. The plan shall include, at a minimum, the following:

(1) An implementation schedule for the plan. The committee shall submit the plan to the board of directors, which shall consider the plan and, once approved, submit the plan to the department and implement the plan no later than July 1, 2003. It is recommended that an implementation schedule include a needs assessment, and timelines for evaluation, revision, completion and approval dates.

(2) Orientation for new faculty. It is recommended that new faculty orientation be initiated within six months from the hiring date. It is recommended that the orientation of new faculty be flexible to meet current and future needs and provide options other than structured college courses for faculty to improve teaching strategies, curriculum development and evaluation strategies. It is recommended that the college consider developing a faculty mentoring program.

(3) Continuing professional development for faculty. It is recommended that the plan clearly specify required components including time frame for continuing professional development for faculty. It is recommended that the plan include the number of hours, courses, workshops, professional and academic conferences or other experiences such as industry internships, cooperatives and exchange programs that faculty may use for continuing professional development. It is recommended that the plan include prescribed and elective topics such as discipline–specific content and educational trends and research. Examples of topics that may be considered include dealing with the complexities of learners, skills in teaching adults, curriculum development, assessment, evaluation, enhancing students’ retention and success, reaching nontraditional and minority students, improving skills in implementing technology and applied learning, leadership development, and issues unique to a particular college. The plan may be inclusive for all college staff, including adjunct and part–time faculty, and include reciprocity features that may facilitate movement from one college to another.

(4) Procedures for accurate record keeping and documentation for plan monitoring. It is recommended that the plan identify the college officials or administrators responsible for the administration, record keeping and ongoing evaluation and monitoring of the plan. It is recommended that plan monitoring, evidence collected, and records maintained showing implementation of the plan be comprehensive in scope. It is recommended that the plan provide for the documentation that each faculty member appropriately possesses, attains or progresses toward attaining minimum competencies.

(5) Consortium arrangements where appropriate, cost–effective and mutually beneficial. It is recommended that the plan provide an outline of existing and potential consortium arrangements including a description of the benefits and cost–effectiveness. It is recommended that the plan contain an approval process for the quality faculty committee to approve and evaluate the consortium services.

(6) Specific activities that ensure that faculty attain and demonstrate instructional competencies and knowledge in their subject or technical areas. It is recommended that the plan identify faculty minimum competencies and explain the method or methods of evaluating competencies. It is recommended that the plan contain procedures for reporting faculty progress. It is recommended that faculty be notified at least once a year of their progress in attaining competencies. It is recommended that the plan include policies and provisions for length of provisional status for staff who do not meet the minimum standards in Iowa Code section 260C.48 as amended by 2002 Iowa Acts, House File 2394. It is recommended that provisional status of individual faculty members not exceed five years.

(7) Procedures for collection and maintenance of records demonstrating that each faculty member has attained or documented progress toward attaining minimum competencies. It is recommended that the plan specify data collection procedures that demonstrate how each full–time faculty member has attained or has documented progress toward attaining minimum competencies. It is recommended that the plan incorporate the current department of education management information system data submission requirements by which each college submits complete human resources data files electronically as a part of the college’s year–end reporting.

(8) Compliance with the faculty accreditation standards of the North Central Association of Colleges and Schools and with faculty standards required under specific programs offered by the community college that are accredited by other accrediting agencies. It is recommended that the plan provide for the uniform reports with substantiating data currently required for North Central Association of Colleges and Schools accreditation.

b. Between July 1, 2003, and June 30, 2006, the department of education shall review the plan and conduct on–site visits to ensure each community college’s compliance and progress in implementing a quality faculty plan. At a minimum, the department shall visit five community colleges each year until the department has conducted on–site visits at 15 community colleges. The colleges will be given at least a 30–day notice of an on–site visit with a written explanation of materials that will be requested prior to and during the visit. The colleges shall provide additional information deemed necessary by the department. The department shall review the following:

(1) Documents submitted by the college that demonstrate that the plan includes all components required by paragraph 21.3(4)“a.”

(2) Documentation submitted by the college that the board of directors approved the plan.

(3) Documentation submitted by the college that the college is implementing the approved plan, including, but not limited to, evidence that the college is meeting the implementation schedule and time frames outlined in the plan; evidence of plan monitoring, evaluation and updating; evidence that the faculty has attained, or is progressing toward attaining, minimum competencies contained in Iowa Code section 260C.48 as amended by 2002 Iowa Acts, House File 2394; evidence that faculty members have been notified of their progress toward attaining minimum competencies; and evidence that the college meets the minimum accreditation requirements for faculty required by the North Central Association of Colleges and Schools.

(4) Documentation that the college administration encourages the continued development of faculty potential as defined in 2002 Iowa Acts, House File 2394, section 5.

(5) Documentation of the human resources report submitted by the college through the department’s community college management information system.

Following the on–site visit to each community college, the department shall submit a report summarizing the department’s findings to the community college. This report will indicate the college’s compliance and progress in implementing the faculty plan, with any suggested improvements and recommendations. All colleges will have received on–site visits and reports summarizing such visits by July 1, 2006.

Pursuant to the authority of Iowa Code section 256.7, the State Board of Education hereby gives Notice of Intended Action to amend Chapter 77, “Standards for Teacher Intern Preparation Programs,” Iowa Administrative Code.

The proposed amendments will govern approval of practitioner preparation programs at four–year colleges or universities that wish to offer a teacher intern preparation program but do not already have a practitioner preparation program approved by the State Board of Education. The proposed amendments to the rules establish the standards for approval of these teacher intern preparation programs, including a site visit by representatives of the Department and additional documentation as needed. The changes also specify that approval may be granted for a term of five years; however, approval for a lesser term may be granted by the State Board if it determines conditions so warrant.

A public hearing will be held in Conference Room 3 North in the Grimes State Office Building, East 14th and Grand Avenue in Des Moines from 4 to 5 p.m. on October 23, 2002. People may present their views at the public hearing orally or in writing. Persons who wish to make oral presentations may contact Dr. Sandra Renegar, Practitioner Preparation Consultant, Division of Early Childhood, Elementary and Secondary Education, Grimes State Office Building, East 14th and Grand Avenue, Des Moines, Iowa 50319–0147, or at (515)281–3427, prior to the date of the public hearing.

Written comments or suggestions will be accepted until5 p.m., October 23, 2002, and should be addressed to Dr.Sandra L. Renegar, Practitioner Preparation Consultant, Iowa Department of Education, at the above address; fax (515)281–7669; or E–mail Sandra.Renegar@ed.state.ia.us. Any person who intends to attend the public hearing and has special requirements, such as hearing or mobility impairments, should contact the Department of Education prior to the hearing.

These amendments are intended to implement Iowa Code sections 256.7 and 256.16.

The following amendments are proposed.

ITEM 1. Amend rule 281—77.4(256) as follows:

281—77.4(256) Criteria for Iowa teacher intern preparation programs. Each institution seeking approval of its program of teacher intern preparation shall file evidence of the extent to which it meets the standards contained in this chapter by means of a written self–evaluation report and an evaluation conducted by the department. For institutions not already offering practitioner preparation programs approved by the state board, the evaluation process shall include a site visit by representatives of the department and additional documentation as needed. After the state board has approved the teacher intern preparation program filed by an institution, teacher intern candidates who complete the program and are recommended by the authorized official of that institution will be issued the appropriate license and endorsement(s).

ITEM 2. Amend rule 281—77.5(256) as follows:

281—77.5(256) Approval of programs. For initial approval, institutions shall submit written documentation of the teacher intern preparation program’s compliance with the program approval rules in 77.10(256) through 77.16(256). For institutions that do not already have practitioner preparation programs approved by the state board, the evaluation process shall include a site visit by representatives of the department and additional documentation as needed. Approval by the state board of the institutions’ teacher intern preparation programs shall be based on the recommendation of the director after study of the factual and evaluative evidence on record about each program in terms of the standards contained in this chapter. Approval, if granted, shall cover the period of time between initial approval and the institution’s next regularly scheduled state review under rules 281 IAC 79.5(256) and 281 IAC 79.6(256). After the initial approval period, approval of the teacher intern preparation program will be included as part of the institution’s reapplication for approval of its entire practitioner preparation program. Approval, if granted to institutions offering only teacher intern preparation programs, shall be for a term of five years; however, approval for a lesser term may be granted by the state board if it determines conditions so warrant.

If approval is not granted, the applying institution will be advised concerning the areas in which improvement or changes appear to be essential for approval. In this case, the institution shall be given the opportunity to present factual information concerning its programs at the next regularly scheduled meeting of the state board. The institution may also reapply at its discretion when it is ready to show what actions have been taken to address the areas of suggested improvement.

Pursuant to the authority of Iowa Code section 542B.6, the Engineering and Land Surveying Examining Board gives Notice of Intended Action to amend Chapter 1, “Administration,” Chapter 4, “Engineering Licensure,” Chapter 6, “Seal and Certificate of Responsibility,” and Chapter 7, “Professional Development,” Iowa Administrative Code.

These amendments provide the new address and phone number for the Engineering and Land Surveying Examining Board office, correct the wording on the comity applicants experience requirements chart to be consistent with Iowa Code section 542B.14, allow for the use of digital signatures as defined in or governed by Iowa Code chapter 554D, and add National Council of Examiners for Engineers and Surveyors (NCEES) examination development committee participation as an allowable professional development activity.

Any interested person may make written or oral suggestions or comments on these proposed amendments on or before October 22, 2002. Comments should be directed to Gleean Coates, Executive Officer, Iowa Engineering and Land Surveying Examining Board at 1920 SE Hulsizer Road, Ankeny, Iowa 50021, telephone (515)281–7360.

These amendments are intended to implement Iowa Code section 17A.9A and chapters 272C, 542B, and 554D.

The following amendments are proposed.

ITEM 1. Amend subrules 1.1(1) and 1.1(2) as follows:

1.1(1) Administration. Administration of the board has not been separated into panels, divisions, or departments. While the expertise of a board member may be called upon to frame special examinations and evaluate applications for licensing in a specialized engineering branch, the board functions in a unified capacity on all matters that may come before it. The board maintains an office at 1918 1920 SE Hulsizer Road, Ankeny, Iowa 50021, and requests or submissions may be directed to the secretary of the board at that location.

1.1(2) Meetings. Regular meetings of the board are held in Ankeny, Iowa. Information concerning the location and dates for meetings may be obtained from the board’s office at 1918 1920 SE Hulsizer Road, Ankeny, Iowa 50021, or by telephoning (515)281–5602 4126.

ITEM 2. Amend the heading of the second chart in subrule 4.2(5) as follows:

ITEM 3. Amend rule 193C—6.1(542B) by adding the following new subrule:

6.1(9) Digital signatures. A digital signature as defined in or governed by Iowa Code chapter 554D meets the signature requirements of this rule.

ITEM 4. Amend subrule 7.3(1) as follows:

7.3(1) PDH conversion. The following chart illustrates the conversion from other units to PDH:

Pursuant to the authority of Iowa Code section 455B.133, the Environmental Protection Commission hereby gives Notice that a public hearing will be held on November 6, 2002, from 6:30 to 8:30 p.m. at the Davenport Public Library, 321 Main Street, Davenport, Iowa. The purpose of the public hearing is to receive oral or written comments regarding proposed changes to Chapter 20, “Scope of Title—Definitions —Forms—Rules of Practice,” and Chapter 28, “Ambient Air Quality Standards,” for the purpose of establishing ambient air quality standards for hydrogen sulfide and ammonia.

The public comment period stated in the original Notice of Intended Action is hereby extended through November 6, 2002. The original Notice of Intended Action, which included announcements for public hearings to be held at other locations in Iowa, was published in the Iowa Administrative Bulletin on August 21, 2002, as ARC 1876B.

Pursuant to the authority of Iowa Code section 455B.133, the Environmental Protection Commission hereby gives Notice that a public hearing will be held on November 6, 2002, from 6:30 to 8:30 p.m. at the Davenport Public Library, 321 Main Street, Davenport, Iowa. The purpose of the public hearing is to receive oral or written comments regarding proposed changes to Chapter 28, “Ambient Air Quality Standards,” for the purpose of adopting by reference the “Ambient Air Sampling Manual” adopted by the Environmental Protection Commission on August 19, 2002.

The public comment period stated in the original Notice of Intended Action is hereby extended through November 6, 2002. The original Notice of Intended Action, which included announcements for public hearings to be held at other locations in Iowa, was published in the Iowa Administrative Bulletin on September 18, 2002, as ARC 1990B.

Pursuant to the authority of Iowa Code section 217.6, the Department of Human Services proposes to adopt Chapter 36, “Assessment Fee for Intermediate Care Facilities for the Mentally Retarded,” and amend Chapter 82, “Intermediate Care Facilities for the Mentally Retarded,” Iowa Administrative Code.

These amendments implement 2002 Iowa Acts, House File 2625, section 36, which authorizes the Department to assess a fee for intermediate care facilities for the mentally retarded that are not operated by the state. The fee is set at6 percent of the total annual revenue of the facility for the preceding fiscal year and is an allowable cost on a facility’s Medicaid cost report. When the fee is implemented, the Department will adjust the Medicaid reimbursement rates for these facilities to reflect the increased cost. Funds generated from the assessment shall be credited to the state medical assistance appropriation. These funds are then used for Medicaid service payments, which draw down additional federal matching funds.

These amendments do not provide for waivers in specified situations because all affected facilities should be treated uniformly under the law.

Any interested person may make written comments on the proposed amendments on or before October 23, 2002. Comments should be directed to the Office of Policy Analysis, Department of Human Services, Hoover State Office Building, 1305 East Walnut Street, Des Moines, Iowa 50319– 0114. Comments may be sent by fax to (515)281–4980 or by E–mail to policyanalysis@dhs.state.ia.us.

The Department will hold a public hearing for the purpose of receiving comments on these amendments on October 24, 2002, from 9 to 10 a.m. in the First Floor Southeast Conference Room, Side 1, Hoover State Office Building, 1305 East Walnut Street, Des Moines. Comments may be offered at the hearing either orally or in writing. Anyone who intends to attend the hearing and has special requirements, such as hearing or vision impairments, should contact the Office of Policy Analysis at (515)281–8440 and advise of the special needs.

These amendments are intended to implement 2002 Iowa Acts, House File 2625, section 36.

The following amendments are proposed.

ITEM 1. Adopt the following new chapter:

CHAPTER 36
ASSESSMENT FEE FOR INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED

These rules describe the assessment of the fee authorized by the Seventy–ninth General Assembly in 2002 Iowa Acts, House File 2625. The rules explain how the fee is determined and paid, and under what conditions collection of the fee will be terminated.

441—36.1(79GA,HF2625) Assessment of fee. Intermediate care facilities for the mentally retarded (ICF/MRs) licensed in Iowa under 481—Chapter 64 that are not operated by the state shall pay a monthly fee to the department. The fee shall equal 6 percent of the total revenue of the facility for the facility’s preceding fiscal year divided by the number of months of facility operation during the preceding fiscal year.

441—36.2(79GA,HF2625) Determination and payment of fee for facilities certified to participate in the Medicaid program. For facilities certified to participate in the Medicaid program, the fee shall be determined and paid as follows:

36.2(1) The assessment for each facility fiscal year shall be based on the financial and statistical report for the facility’s preceding fiscal year submitted pursuant to rule 441— 82.5(249A), as adjusted pursuant to 441—subrules 82.5(10) and 82.17(1).

36.2(2) The department shall notify each facility of the amount of the fee assessed for each fiscal year following submission of the financial and statistical report for the facility’s preceding fiscal year. The fee is subject to adjustment based on adjustments to the financial and statistical report.

36.2(3) The department shall deduct the monthly amount due from medical assistance payments to the facility. The department shall also deduct from medical assistance payments any additional amount due for past months as a result of an adjustment to the assessment.

441—36.3(79GA,HF2625) Determination and payment of fee for facilities not certified to participate in the Medicaid program. For facilities not certified to participate in the Medicaid program, the fee shall be determined and paid as follows:

36.3(1) Any licensed ICF/MR in Iowa that is not operated by the state and is not certified to participate in the Medicaid program shall submit Form 470–0030, Financial and Statistical Report, as required for participating facilities by rule 441—82.5(249A), for purposes of determining the amount of the assessment. The department may audit and adjust the reports submitted, as provided for participating facilities in 441—subrules 82.5(10) and 82.17(1).

36.3(2) The assessment for each facility fiscal year shall be based on the financial and statistical report for the facility’s preceding fiscal year as submitted and audited pursuant to subrule 36.3(1).

36.3(3) The department shall notify each facility of the amount of the fee assessed for each fiscal year following submission of the financial and statistical report for the facility’s preceding fiscal year. The fee is subject to adjustment based on adjustments to the financial and statistical report.

36.3(4) The facility shall pay the assessed fee to the department on or before the fifteenth day of each month. Any additional amount due for past months as the result of an adjustment to the initial assessment is due 30 days after the department notifies the facility of the additional amount.

441—36.4(217) Termination of fee assessment. If federal financial participation to match the assessed fee becomes unavailable under federal law, the assessment terminates on the date the federal statutory, regulatory, or interpretive change takes effect.

These rules are intended to implement 2002 Iowa Acts, House File 2625, section 36.

ITEM 2. Amend rule 441—82.5(249A) by adopting the following new subrule:

82.5(13) Assessed fee. The fee assessed pursuant to 441—Chapter 36 shall be an allowable cost for cost reporting and audit purposes.

a. For the purpose of implementing the assessment, Medicaid reimbursement rates shall be recalculated effective February 1, 2003, as provided in paragraph “b.”

b. For purposes of rates paid for services rendered after February 1, 2003, each facility’s annual costs for periods before February 1, 2003, shall be increased by an amount equal to 6 percent of the facility’s annual revenue for the preceding fiscal year.

Pursuant to the authority of Iowa Code section 239B.4, subsection (4), the Department of Human Services proposes to amend Chapter 45, “Payment,” Iowa Administrative Code.

These amendments change language regarding payment of benefits under the Family Investment Program to clarify that the Department may (instead of shall) issue benefits by means of direct deposit to a financial institution or by electronic funds transfer. This is consistent with the language in Iowa Code section 239B.3. The Department currently offers direct deposit, but not electronic funds transfer.

These amendments also remove a provision relating to underpayments due to erroneous reporting of the income or resources of an alien’s sponsor. Since the rules requiring deeming of a sponsor’s income and resources have been rescinded, this provision is obsolete.

These amendments do not provide for waivers in specified situations. The first change makes the rules consistent with state law. The second change is a benefit to recipients.

Any interested person may make written comments on the proposed amendments on or before October 23, 2002. Comments should be directed to the Office of Policy Analysis, Department of Human Services, Hoover State Office Building, 1305 East Walnut Street, Des Moines, Iowa 50319– 0114. Comments may be sent by fax to (515)281–4980 or by E–mail to policyanalysis@dhs.state.ia.us.

These amendments are intended to implement Iowa Code section 239B.3.

The following amendments are proposed.

ITEM 1. Amend rule 441—45.21(239B) as follows:

441—45.21(239B) Address. Assistance warrants shall be mailed to the recipient’s current address or, upon request, to a post office box, bank, or to any other address for which the recipient has good reason for the request. Assistance warrants shall be mailed to the protective payee, conservator, or guardian (if applicable) in cases involving said persons. Assistance shall may also be paid by direct deposit to the recipient’s own account in a financial institution or by means of electronic benefits transfer.

ITEM 2. Amend subrule 45.24(1), paragraph “b,” by rescinding subparagraph (3).

Pursuant to the authority of Iowa Code section 249A.4, the Department of Human Services proposes to amend Chapter 79, “Other Policies Relating to Providers of Medical and Remedial Care,” Iowa Administrative Code.

These amendments add conditions for children’s hospitals to qualify for Medicaid disproportionate share payments from the Graduate Medical Education and Disproportionate Share Fund, as directed by 2002 Iowa Acts, House File 2487.

The Graduate Medical Education and Disproportionate Share Fund was created in 1997 to provide a means of directly reimbursing qualifying hospitals for the costs associated with providing medical education and serving a disproportionate share of poor, indigent, nonreimbursed, or nominally reimbursed patients. The Department applies a formula to the cost and utilization data for each hospital qualifying for disproportionate share payments to obtain a dollar value. Each hospital’s dollar value is divided by the total dollar value for all qualifying hospitals, resulting in a percentage, which is applied to the amount allocated for disproportionate share payments for the year to determine the payment to that hospital. Payments are issued in monthly installments.

The amendments allow certain hospitals with distinct areas that provide services predominantly to children to report their costs and Medicaid utilization for those areas separately for purposes of qualifying for disproportionate share payments. To qualify for payment, a children’s hospital must be a voting member of the National Association of Children’s Hospitals and Related Institutions and have Medicaid and low–income utilization rates in the children’s area of1 percent or greater. Under current rules, the whole hospital must qualify, and either the low–income utilization rate must exceed 25 percent or the Medicaid inpatient utilization rate must exceed one standard deviation from the statewide average rate.

These amendments do not provide for waivers in specified situations because all children’s hospitals should be subject to the same formula for disproportionate share payments. Hospitals may request a waiver of any part of the formula under the Department’s general rule on exceptions at rule 441—1.8(217).

The substance of these amendments is also Adopted and Filed Emergency and is published herein as ARC 2034B. The purpose of this Notice is to solicit comment on that submission, the subject matter of which is incorporated by reference.

Any interested person may make written comments on the proposed amendments on or before October 23, 2002. Comments should be directed to the Office of Policy Analysis, Department of Human Services, Hoover State Office Building, 1305 East Walnut Street, Des Moines, Iowa 50319– 0114. Comments may be sent by fax to (515)281–4980 or by E–mail to policyanalysis@dhs.state.ia.us.

These amendments are intended to implement 2002 Iowa Acts, House File 2487, section 1.

Pursuant to the authority of Iowa Code section 249H.4, the Department of Human Services proposes to amend Chapter 161, “Iowa Senior Living Trust Fund,” Iowa Administrative Code.

These amendments clarify that nursing facilities participating in the funding of the Iowa Senior Living Trust Fund are allowed the $5,000 administration fee each state fiscal year. The amendments also correct a Department address that has changed due to restructuring and update the implementation references to reflect the codification of the authorizing legislation, 2000 Iowa Acts, chapter 1004.

These amendments do not provide for waivers in specified situations because the administration fee should be uniform for each participating facility.

Any interested person may make written comments on the proposed amendments on or before October 23, 2002. Comments should be directed to the Office of Policy Analysis, Department of Human Services, Hoover State Office Building, 1305 East Walnut Street, Des Moines, Iowa 50319– 0114. Comments may be sent by fax to (515)281–4980 or by E–mail to policyanalysis@dhs.state.ia.us.

These amendments are intended to implement Iowa Code chapter 249H.

The following amendments are proposed.

ITEM 1. Amend the parenthetical implementation reference for rules 441—161.1(78GA,SF2193) to 441— 161.4(78GA,SF2193) as follows:

(78GA,SF2193 249H)

ITEM 2. Amend subrule 161.4(1) as follows:

161.4(1) Participation agreement. Iowa government–owned nursing facilities participating in the Iowa Medicaid program and wishing to participate in the funding of the senior living trust fund shall contact the Department of Human Services, Division of Medical Services Office of Deputy Director for Policy, Fifth Floor, 1305 E. Walnut Street, Des Moines, Iowa 50319–0114, for information regarding the conditions of participation. Upon acceptance of the conditions of participation, the facility shall sign Form 470–3763, Participation Agreement.

ITEM 3. Amend subrule 161.4(2) as follows:

161.4(2) Reimbursement. Upon acceptance of the participation agreement, the department shall authorize increased reimbursement to the participating facility for nursing facilities services provided under the Medicaid program. The facility shall retain $5,000 of the additional reimbursement received per agreement as a processing payment and during each state fiscal year as an administration fee. The facility shall refund the remainder of the additional reimbursement through intergovernmental transfer to the department for deposit of the federal share (less the $5,000 retained by the facility) in the Iowa senior living trust fund and the nonfederal share of money in the medical assistance appropriation.

ITEM 4. Amend 441—Chapter 161, implementation clause, as follows:

These rules are intended to implement 2000 Iowa Acts, Senate File 2193, sections 4 and 5 Iowa Code chapter 249H.

Pursuant to the authority of Iowa Code section 455A.5, the Natural Resource Commission hereby gives Notice of Intended Action to amend Chapter 22, “Wildlife Habitat on Private Lands Promotion Program,” Iowa Administrative Code.

These rules designate the procedures that will be used to establish wildlife habitat on private lands. This amendment changes the funding source, incorporates the pheasant and quail restoration program, and provides for the collection and distribution of seed from the Wildlife Bureau’s Seed Harvest Program.

Any person may make written suggestions or comments on the proposed amendments on or before October 24, 2002. Such written materials should be directed to the Wildlife Bureau Chief, Department of Natural Resources, Wallace State Office Building, Des Moines, Iowa 50319–0034; fax (515) 281–6794. Persons who wish to convey their views orally should contact the Wildlife Bureau at (515)281–6156, or at the Wildlife Bureau offices on the fourth floor of the Wallace State Office Building.

There will be a public hearing on October 24, 2002,from 1 to 4 p.m. in the Fourth Floor West Conference Room,Wallace State Office Building, Des Moines, Iowa, at which time persons may present their views either orally or in writing. At the hearing, persons will be asked to give their names and addresses for the record and to confine their remarks to the subject of the amendments.

Any persons who intend to attend the public hearing and have special requirements such as those related to hearing or mobility impairments should contact the Department of Natural Resources and advise of specific needs.

These amendments are intended to implement Iowa Code chapters 456A and 483A.

The following amendments are proposed.

ITEM 1. Amend rule 571—22.1(456A,483A) as follows:

571—22.1(456A,483A) Purpose. The purpose of these rules is to designate procedures by which revenues from the sale of wildlife habitat stamps and income tax checkofffund state fish and game protection fund will be used to assist landowners in establishing wildlife habitat on private lands. These rules authorize department staff to work with conservation organizations, educational groups, and private landowners to improve wildlife habitat on private land.

ITEM 2. Amend rule 571—22.2(456A,483A) as follows:

571—22.2(456A,483A) Authority. Iowa Code section 483A.3 authorizes the expenditure of wildlife habitat stamp funds for “the development and enhancement of wildlife lands and habitat areas.” Iowa Code section 456A.16 authorizes an income tax checkoff for habitat development for game and nongame wildlife 456A.19 authorizes that the state fish and game protection fund shall be expended solely in carrying on the activities embraced in the fish and wildlife division. Iowa Code section 483A.25 directs the department to spend 60 percent of the revenue derived from an increase in the hunting license fee to fund a pheasant and quail restoration program. The natural resource commission, hereinafter referred to as the commission, acting through its director, will enter into agreements with landowners and conservation groups to fulfill the requirements of the law.

ITEM 3. Amend rule 571—22.3(456A,483A) as follows:

571—22.3(456A,483A) Project scope. This program will provide cost–sharing assistance to landowners from habitat stamp and tax checkoff revenues. Tax checkoff funds will be used to establish farmstead and feedlot shelterbelts, and habitat stamp funds will be used to provide temporary winter habitat plots, and habitat practices designed to implement the pheasant and quail restoration program throughout the state. Declines in wildlife populations in northern Iowa have been caused in part by the loss of secure food and shelter against winter storms. Shelterbelts will also provide significant energy savings to rural homes. Shelterbelts and habitat plots will demonstrate the value of winter habitat to wildlife in intensively farmed regions of the state. The purpose of these practices is to assist Iowa’s landowners with developing and enhancing wildlife habitat on private lands in cooperation with other state, federal, and county agencies as well as conservation organizations.

ITEM 4. Amend rule 571—22.4(456A,483A) as follows:

571—22.4(456A,483A) Availability of funds. Habitat stamp funds are dependent on stamp sales. Tax checkoff funds depend on voluntary contributions from Iowa taxpayers. The amount of moneys available at any time will be determined by revenues received by the department and by matching contributions from conservation groups. Final stamp sales for each calendar year will be determined by July 1 of the following year. Tax checkoff funds will be available by January 31 of the following calendar year.

22.4(1) Allotments for this program. Funds available for assisting landowners shall be in the department’s budget in accordance with legislative appropriations. Funds will be made available during a fiscal year of July 1 to June 30.

22.4(2) Matching funds. To maximize the amount of wildlife habitat actually established, the department may accept contributions from any governmental or private conservation group to help establish shelterbelts or winter habitat demonstration areas or habitat practices designed to implement the pheasant and quail restoration program. Department funds may also be used to match other funding sources or incentive programs.

ITEM 5. Amend subrule 22.5(6), paragraphs “a,” “b,” “c” and “d,” as follows:

a. Up to $55 $90 per acre for standing corn planted on annual set–aside acres land not being rowcropped.

b. Up to $70 $100 per acre for standing corn left on agricultural ground.

c. Up to $30 $50 per acre for planting forage sorghum and grain sorghum.

d. Up to $50 $70 per acre for planting forage sorghum and corn.

ITEM 6. Renumber rule 571—22.7(456A,483A) as 571—22.8(456A,483A) and adopt new rule 571— 22.7(456A,483A) as follows:

571—22.7(456A,483A) Pheasant and quail restoration practices. This rule delineates eligibility and procedures for establishing pheasant and quail restoration practices.

22.7(1) Eligibility. The program is available statewide. To be eligible for cost assistance, landowners must enter into a written agreement with the department specifying the obligations of both parties.

22.7(2) Applications for assistance. Applications will be accepted only from those who are eligible as noted above.

a. Applications must be submitted on forms furnished by the department.

b. Applications and contracts must be received by June 1 to provide adequate time for site inspection and practice design. The application period may be extended indefinitely, or until all available funds have been committed. Landowners will be notified within 30 days of their acceptance or rejection.

22.7(3) Project review and selection.

a. Projects will be reviewed by the department wildlife biologist, who will then recommend that the commission enter into agreements with the successful applicants.

b. Projects will be selected on the basis of habitat potential, site suitability, priority locations, and other habitat factors, to determine those projects with the greatest chance of benefiting wildlife populations.

22.7(4) Contract agreements. The director is authorized to enter into agreements with landowners to carry out the purposes of this program.

a. Agreement forms will be provided by the department, and shall explicitly state the terms of the agreement including restoration practices.

b. Cost–sharing assistance will not be provided unless an agreement has been signed by both parties.

c. Contracts may be amended by mutual agreement of both parties.

22.7(5) Restoration practices. Pheasant and quail restoration practices will be guided by the Natural Resource Conservation Service (NRCS) field office technical guide (FOTG).

a. Approved practices include: Brush management (314), conservation cover (327), critical area planting (342), early successional development/management (647), forage harvest management (511), pasture and hay planting (312), prescribed burning (338), prescribed grazing (528A), tree/shrub establishment (612), upland wildlife habitat management (645), wetland enhancement (659), wetland restoration (657), wetland wildlife habitat management (644).

b. Deviation from these practices or new practices must be approved by a department wildlife biologist.

ITEM 7. Adopt new rule 571—22.9(456A,483A) as follows:

571—22.9(456A,483A) Wildlife habitat enhancement on public and private lands. The department’s primary goal for the wildlife bureau’s seed harvest program is to provide diverse native plant materials to meet the diverse seeding requirements of state and federal land that is owned or managed by the department.

22.9(1) Private land. The department may enter into an agreement with Pheasants Forever and the Iowa Native Seed Growers Association to meet the challenge of providing native plant materials to conservation groups, educational groups, and private landowners for use in promoting and establishing wildlife habitat and conservation plantings in Iowa. These materials include, but are not limited to, seed and seedlings of prairie plants, grains, and agricultural crop seeds. All native prairie plant materials provided free to Iowa landowners will be purchased through this cooperative agreement.

22.9(2) Public land. The department’s seed harvest program will harvest, process, and distribute native plant ma–terials for the purpose of improving wildlife habitat ondepartment–managed land in Iowa. Native plant materials include prairie grasses and forbs and mast crops from trees. In addition, native plant materials may be provided free to educational groups (schools) or conservation groups who want to carry out educational, environmental or demonstration plantings that will promote prairies and wildlife habitat. These free materials will be limited to $300 or less in value. The department may enter into agreements with conservation partners or governmental agencies to utilize prairie seed and seedlings as a matching source of in–kind value to secure additional funding or land acquisition, providing all seed materials remain on lands owned, managed or to be acquired by the department.

Pursuant to the authority of Iowa Code sections 17A.3 and 147.76, the Board of Nursing hereby gives Notice of Intended Action to amend Chapter 3, “Licensure to Practice—Registered Nurse/Licensed Practical Nurse,” Iowa Administrative Code.

This amendment adds a definition of “unlicensed student” to the rules.

Any interested person may make written comments or suggestions on or before October 22, 2002. Such written materials should be directed to the Executive Director, Iowa Board of Nursing, RiverPoint Business Park, 400 S.W. 8th Street, Suite B, Des Moines, Iowa 50309–4685. Persons who wish to convey their views orally should contact the Executive Director at (515)281–3256, or in the Board office at S.W. 8th Street, by appointment.

This amendment is intended to implement Iowa Code section 152.1.

The following amendment is proposed.

Amend rule 655—3.1(17A,147,152,272C) by adopting the following new definition in alphabetical order:

“Unlicensed student” means a person enrolled in a nursing education program who has never been licensed as a registered nurse or licensed practical/vocational nurse in any U.S. jurisdiction.

Pursuant to the authority of Iowa Code sections 17A.3 and 147.76, the Board of Nursing hereby gives Notice of Intended Action to amend Chapter 3, “Licensure to Practice—Registered Nurse/Licensed Practical Nurse,” Iowa Administrative Code.

These proposed amendments reduce the time between the authorization of NCLEX® examination candidates to test and the first possible test date.

Any interested person may make written comments or suggestions on or before October 22, 2002. Such written materials should be directed to the Executive Director, Iowa Board of Nursing, RiverPoint Business Park, 400 S.W. 8th Street, Suite B, Des Moines, Iowa 50309–4685. Persons who wish to convey their views orally should contact the Executive Director at (515)281–3256 or in the Board office at S.W. 8th Street, by appointment.

These amendments are intended to implement Iowa Code chapters 147 and 152.

The following amendments are proposed.

ITEM 1. Amend subrule 3.4(3), paragraph “b,” subparagraph (6), to read as follows:

(6) Self–schedule the examination at an approved testing center. Applicants who do not test within 95 91 days of authorization are required to submit a new application and fee to the board.

ITEM 2. Amend subrule 3.4(4), paragraph “b,” subparagraph (10), to read as follows:

(10) Self–schedule the examination at an approved testing center. Applicants who do not test within 95 91 days of authorization are required to submit a new application and fee to the board.

Pursuant to the authority of Iowa Code sections 135.37 and 135.38, the Department of Public Health hereby gives Notice of Intended Action to amend Chapter 22, “Practice of Tattooing,” Iowa Administrative Code.

The purpose of these amendments is to clarify and provide additional infection control procedures and to facilitate the performance of inspections by county health officials.

Any interested person may make written suggestionsor comments on the proposed amendments on or beforeOctober 22, 2002. Written comments may be sent to TomNewton, Division of Health Protection and Environmental Health, Department of Public Health, Lucas State Office Building, Des Moines, Iowa 50319–0075, fax (515)281– 4529.

There will be a public hearing on October 22, 2002, at9 a.m. (local Iowa time) over the Iowa Communications Network (ICN) at which time persons may present their views. The sites for the public hearing are as follows:

Department of Public Health

ICN Room, 6th Floor

Lucas State Office Building

321 East 12th Street

Des Moines

Green Valley Area Education Agency 14

Turner Room

1405 N. Lincoln

Creston

Northern Trails Area Education Agency 2

State Room

9184B 265th Street

Clear Lake

Buena Vista University

Spirit Lake Campus

2008 Hill Avenue

Spirit Lake

Dubuque Downtown – Northeast Iowa
Community College

Room 101

700 Main Street

Dubuque

Davenport Public Library

Meeting Room A

321 Main

Davenport

Iowa City Public Library

Meeting Room D

123 South Linn Street

Iowa City

Ottumwa National Guard Armory

2858 N. Court Road

Ottumwa

Any persons who plan to attend the public hearing and have special requirements, such as hearing or mobility impairments, should contact the Department of Public Health and advise of specific needs.

These amendments are intended to implement Iowa Code sections 135.37 and 135.38.

The following amendments are proposed.

ITEM 1. Amend rule 641—22.1(135) as follows:

641—22.1(135) Purpose. The purpose of this chapter is to stipulate the permit and operational requirements for tattoo artists and tattoo establishments.

ITEM 2. Amend rule 641—22.2(135), definition of “tattoo establishment,” as follows:

“Tattoo establishment” means the location building or mobile unit where tattooing is practiced.

ITEM 3. Rescind subrule 22.3(4) and adopt new subrule 22.3(4) in lieu thereof and adopt new subrules 22.3(5) through 22.3(7) as follows:

22.3(4) Tattoo artists and tattoo establishments which are in compliance with Iowa Code section 135.37 and 641— Chapter 22 are not relieved from the requirements of any other applicable state laws or local ordinances.

22.3(5) Tattooing shall be practiced only in facilities that have received a tattoo establishment permit from the department.

22.3(6) Tattooing shall not be practiced in a residence unless the tattoo establishment is completely separated from the living quarters by a solid permanent partition. A solid door leading to the living quarters shall be permitted, provided it remains closed during business hours. A direct outside entrance to the tattoo establishment shall be provided.

22.3(7) Tattoo establishments shall be inspected annually.

ITEM 4. Amend rule 641—22.4(135) as follows:

22.4(1) Tattooing shall not be practiced in a residence unless the tattoo establishment is completely separated from the living quarters by a solid permanent partition. A solid door leading to the living quarters shall be permitted, provided it remains closed during business hours. A direct outside entrance to the tattoo establishment shall be provided. Tables, chairs, and other general use equipment shall be constructed of impervious or smooth and easily cleanable material.

22.4(2) Tattoo establishments shall have potable hot and cold water under pressure. A sink for handwashing supplied with potable hot and cold running water shall be available in or directly adjacent to the tattooing area. Hand–washing facilities shall be supplied with liquid soap and single–use paper towels.

22.4(3) All tattoo establishments shall be equipped with toilet and hand–washing facilities which are connected to water and sewage disposal systems. Hand–washing lavatories shall be supplied with cleansing compound and single towel service. Toilet facilities must be available for employee use or patron use.

22.4(4) to 22.4(6) No change.

22.4(7) All refuse shall be stored in rigid containers with tight–fitting covers plastic liners which are emptied at least once each business day.

22.4(8) Closed cabinets shall be used for the exclusive storage of instruments, dyes, pigments, stencils, tattoo machines, and other equipment. shall be provided for each tattoo artist.

22.4(9) Smoking or consumption of food or drink shall not be allowed in any area where the actual tattoo procedure is being performed.

22.4(10) No change.

ITEM 5. Rescind rule 641—22.5(135) and adopt the following new rule 641—22.5(135) in lieu thereof:

22.5(1) Cups to hold ink or dye shall be for single–patron use.

22.5(2) Any dye or ink in which needles were dipped shall not be used on another person.

22.5(3) All tubes, needle bars, and needles used for the tattoo procedure that are not sterile, for single–patron use and disposable shall be physically cleaned with a detergent according to manufacturers’ recommendations and then steam sterilized or dry–heat sterilized before use on another patron.

22.5(4) Steam sterilization shall be at 250 degrees Fahrenheit (121 degrees Celsius) for 15 minutes at a minimum pressure of 15 pounds per square inch.

22.5(5) Dry–heat sterilization shall be at 350 degrees Fahrenheit (170 degrees Celsius) for one hour.

22.5(6) Sterilizers shall be monitored monthly for spores of Bacillus subtilis and records shall be maintained of results.

22.5(7) Each tattoo establishment shall maintain written procedures to follow in the event of positive spore tests; for example, materials processed in that sterilizer, dating from the sterilization cycle having the positive biological indicator to the next cycle showing satisfactory biologic indicator challenge results, must be considered nonsterile and must be reprocessed before being used.

22.5(8) Each tattoo establishment shall be equipped with a container designated for disposal of used needles and other sharps. A written plan for disposal shall be required.

22.5(9) Any bottles of solution shall be labeled as to contents and used according to manufacturers’ directions.

22.5(10) Use of clippers is recommended for removal of unwanted hair. After use, clippers shall be cleaned with detergent and water and then disinfected with 70 percent ethyl or isopropyl alcohol for ten minutes or with quaternary ammonium compounds as directed on the product label.

22.5(11) Razors shall be for single–patron use and shall be disposable.

22.5(12) Topical ointments shall be for single–patron use.

22.5(13) All equipment shall be maintained in a clean and sanitary condition.

ITEM 6. Amend rule 641—22.6(135) as follows:

22.6(1) and 22.6(2) No change.

22.6(3) Tattoo artists shall wear clean outer garments. It is recommended, but not required, that sterile gloves be worn by the tattoo artists during the tattoo procedure. Gloves shall be changed after each tattoo. Hands shall be washed after gloves are removed.

22.6(4) The skin area to be tattooed shall first be cleansed with a germicidal soap and water. Single–use towels or sponges (gauze) shall be used during the cleansing procedure.

22.6(5) Before placing the tattoo design on the patron’s skin, the tattoo artist shall prepare the skin with an antiseptic such as 70 percent ethyl or isopropyl alcohol or 10 percent iodophor solution. iodophor solution, chlorohexidine gluconate solution, or other antiseptic approved by the department. The solution shall be applied with sterile cotton or sterile gauze.

22.6(6) No change.

22.6(7) After the tattooing is completed, a sterile dressing shall be applied to the tattoo area.

22.6(8) No change.

ITEM 7. Rescind rule 641—22.7(135) and adopt the following new rule in lieu thereof:

22.7(1) No tattoo establishment shall be operated in the state without having a permit to operate issued by the department.

22.7(2) Each person acquiring or establishing a tattoo establishment shall apply for a permit prior to beginning operation.

22.7(3) A permit to operate shall be issued to a new establishment when the department or its representative has successfully completed an on–site inspection. Permits shall be posted in a conspicuous place in the tattoo establishment.

22.7(4) Applications are available upon request fromthe Iowa Department of Public Health, Division of Health Protection and Environmental Health, Tattoo PermitProgram, Lucas State Office Building, Des Moines, Iowa 50319–0075.

22.7(5) An annual, nonrefundable application fee of $25, payable to the Iowa Department of Public Health, shall be remitted with the initial or renewal tattoo establishment application.

22.7(6) The annual fee for each tattoo artist permit shall be $40.

22.7(7) Tattoo artist permits and tattoo establishment permits are nontransferable.

22.7(8) All permits expire on December 31 of each year, regardless of date of issue. Permits shall be renewed annually upon acceptance of a renewal application provided by the department and receipt of the renewal fee.

22.7(9) The owner of the tattoo establishment shall be billed $200 for each tattoo establishment inspection. Tattoo establishments shall be inspected annually. When the tattoo establishment is located within a contracted area of a board of health, the costs billed will be paid to the contracted board of health, or its designee.

Pursuant to the authority of Iowa Code section 136C.3, the Department of Public Health hereby gives Notice of Intended Action to amend Chapter 38, “General Provisions for Radiation Machines and Radioactive Materials”; Chapter 39, “Registration of Radiation Machine Facilities, Licensure of Radioactive Materials and Transportation of Radioactive Materials”; Chapter 40, “Standards for Protection Against Radiation”; Chapter 41, “Safety Requirements for the Use of Radiation Machines and Certain Uses of Radioactive Materials”; and Chapter 45, “Radiation Safety Requirements for Industrial Radiographic Operations,” Iowa Administrative Code.

The following itemize the proposed changes.

Items 1, 3, 9, 21, and 72 amend the rules to reflect current federal regulations.

Item 2 amends the definitions of: “airborne radioactivity area,” to include all airborne radioactive material; “monitoring,” to clarify wording; “prescribed dosage,” to change wording from quantity to activity; “prescribed dose,” to add wording that includes brachytherapy afterloaders; “public dose,” to change wording from radiation possessed to radiation released; “reportable medical event,” to add more descriptive wording and to add wording about exposure from a leaking sealed source or intervention by the patient; “shallow dose equivalent,” to add wording about exposure to the whole body and to delete the average; and “written directive,” to delete wording that is detailed in another rule. Item 2 also adds definitions for “authorized medical physicist” and those related to respirators in order to meet NRC compatibility requirements.

Item 4 adds wording to include registration as well as certificates, both of which the agency currently issues.

Items 5, 30, and 54 expand the wording for clarity and to meet NRC compatibility requirements.

Items 6 and 23 rescind the current subrules and adopt new subrules in order to meet NRC compatibility requirements.

Item 7 changes the requirement to include transfer of devices, adds an effective date for labeling, and adds two new devices to labeling requirements in order to meet NRC compatibility requirements.

Item 8 rescinds a subparagraph and adopts three new subparagraphs in order to meet NRC compatibility requirements. The requirements for reports and records are added.

Item 10 amends the definition of “class” and “declared pregnant woman” to meet NRC compatibility requirements.

Item 11 adds exposure limits for the skin of the whole body. This is an NRC compatibility requirement.

Item 12 clarifies from what portion of the body the exposures must be taken. This is an NRC compatibility requirement.

Item 13 changes wording to include areas not previously regulated and may cause facilities to reevaluate public access areas. This is an NRC compatibility requirement.

Items 14 and 42 adopt new wording to include exposure limits to patient visitors. This is an NRC compatibility requirement.

Item 15 requires prompt processing of dosimetry. This is an NRC compatibility requirement.

Item 16 adds decontamination to the licensee requirements. This is an NRC compatibility requirement.

Items 17, 18, and 19 add wording to include respirators in order to meet NRC compatibility requirements.

Item 20 adds a new rule intended to protect employees from discrimination when they are involved in certain protected activities. The NRC recommended this rule because there is no protection currently.

Item 22 expands the definition of “authorized nuclear pharmacist” and “authorized user” to meet NRC compatibility requirements. The definition includes more ways to become an “authorized nuclear pharmacist” or an “authorized user.” Item 22 also includes a new definition for “authorized medical physicist.” The definition of “radiation safety officer” was added to this chapter because it is expanded from the definition in 641—Chapter 38. This is an NRC compatibility requirement.

Item 24 expands the requirements to include additional items required to be included in the instruction of personnel. This is an NRC compatibility requirement.

Item 25 adds wording to clearly delineate who has authority for control of radioactive material. Item 25 also adds wording for mobile services that is now only found in regulatory guides. This is an NRC compatibility requirement.

Items 26 and 28 add reportable events to the record requirements. This is an NRC compatibility requirement.

Item 27 shortens the time frame for reporting reportable medical events. This is an NRC compatibility requirement.

Item 29 rescinds requirements for written directives from this subrule. These requirements are added in new subrule 41.2(87). Any changes are an NRC compatibility requirement.

Item 31 adds wording to require a more detailed description of equipment in a report that is already commonly submitted. This is an NRC compatibility requirement.

Item 32 allows elimination of certain surveys. This is an NRC compatibility requirement.

Item 33 corrects wording regarding the half–life in terms of days that was in error.

Items 34, 35, and 36 add wording to include common sources of material. This is an NRC compatibility requirement.

Item 37 adds a new category of patients to be discussed in training. This is an NRC compatibility requirement.

Items 38, 42 and 44 add a substitute for the radiation safety officer. This is an NRC compatibility requirement.

Item 39 changes the requirement to allow a semiprivate room if both individuals are being treated. This is an NRC compatibility requirement.

Items 40 and 41 require sealed sources to meet certain requirements. This is an NRC compatibility requirement.

Item 43 requires that emergency equipment be present. This is an NRC compatibility requirement.

Item 45 adds a new paragraph to require accountability for sources. This is an NRC compatibility requirement.

Item 46 is amended to include remote afterloaders. This is an NRC compatibility requirement.

Items 47, 48, 49, 50, 52, 53, 55, and 64 are amended to include remote afterloaders and gamma stereotactic radiosurgery units. This is an NRC compatibility requirement.

Item 51 is amended to require nationally recognized protocols for calibration. This is an NRC compatibility requirement.

Items 54, 56, 58, 59, 60, 61, 62, 63, 65, and 68 rescind the current wording and adopt new wording in order to meet NRC compatibility requirements.

Items 57, 66, and 69 change the date by which authorized individuals will meet the requirements of these rules.

Item 67 adds an omitted cross reference.

Item 70 adds new subrules in order to meet NRC compatibility requirements. It also includes a subrule for written directives which, in Item 29, were rescinded.

Item 71 rescinds a requirement that had been omitted in previous rule making.

Items 73 and 74 add requirements for approved processing services of monitoring devices and clarify wording in order to meet NRC compatibility requirements.

Items 75, 76, 77, 79, 80, 81, 82, and 83 amend or add requirements for well–logging in order to be compatible with NRC requirements.

Item 78 amends record–keeping times, methods, intervals, and reports in order to be compatible with NRC requirements.

These rules are subject to waiver pursuant to the Department’s exemption provision contained at 641-38.3(136C). For this reason, the Department has not provided a specific provision for waiver of these particular rules.

Any interested person may make written suggestions or comments on these proposed amendments prior to the close of business on October 22, 2002. Such written materials should be directed to Donald A. Flater, Chief, Bureau ofRadiological Health, Department of Public Health, 401 SW 7th Street, Suite D, Des Moines, Iowa 50309–4611; fax (515) 725–0318; or E–mail dflater@idph.state.ia.us.

A public hearing will be held on October 22, 2002, at8:30 a.m. in the Conference Room, Department of Public Health, 401 SW 7th Street, Suite D, Des Moines, Iowa, at which time persons may present their views either orally or in writing. At the hearing, persons will be asked to give their names and addresses for the record and to confine their remarks to the subject of the amendments.

Any person who plans to attend the public hearing and has special requirements such as those related to hearing or mobility impairments should contact the Department to advise of specific needs.

These amendments are intended to implement Iowa Code chapter 136C.

The following amendments are proposed.

ITEM 1. Amend subrule 38.1(2) as follows:

38.1(2) All references to Code of Federal Regulations (CFR) in this chapter are those in effect as of July 1, 2002 January 1, 2003.

ITEM 2. Amend rule 641-38.2(136) as follows:

Amend the following definitions:

“Airborne radioactivity area” means a room, enclosure, or area in which airborne radioactive material (composed wholly or partly of licensed material) exists in concentrations(1) in excess of the derived air concentrations (DACs) specified in Appendix A of 641-Chapter 40; or (2) to such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12 DAC–hours.

“Monitoring (radiation monitoring, radiation protection monitoring)” means the measurement of radiation levels, radioactive material concentrations, surface area activities concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these rules, “radiation monitoring” and “radiation protection monitoring” are equivalent terms.

“Prescribed dosage” means the quantity specified activity or range of activity of radiopharmaceutical activity unsealed radioactive material as documented:

1. and 2. No change.

“Prescribed dose” means:

1. For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

2. For teletherapy, particle accelerators and X–ray systems, the total dose and dose per fraction as documented in the written directive; or

3. For manual brachytherapy, either the total source strength and exposure time or the total doses, as documented in the written directive. ; or

“Public dose” means the dose received by a member of the public from exposure to sources of radiation possessed radiation or to radioactive material released by a licensee, registrant, or other person, or to any other source of radiation under the control of a licensee, registrant, or other person. It does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered sources of radiation and released in accordance with 41.2(27) or from voluntary participation in medical research programs.

“Reportable medical event” means the administration of radioactive material for diagnostic medical use that results in the patient’s or human research subject’s receiving medical event, except for an event that results from patient intervention, in which the administration of byproduct material or radiation from byproduct material results in:

1. Greater or less than 20 percent of a prescribed dose The total dose delivered differs from the prescribed dose by 20 percent or more;

2. A dose intended for another individual; or The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or

3. A dose that was not prescribed by an authorized user. The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more.

“Shallow dose equivalent” (H_s), which applies to the external exposure of the skin of the whole body or the skin of an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm²) averaged over an area of 1 square centimeters.

“Written directive” means an order in writing for a specific patient or human research subject, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or by an individual qualified by training and experience to conduct particle accelerator therapy or radiation for X–ray therapy, except as specified in paragraph “6” of this definition, containing the following information:

b. After implantation but prior to completion of the procedure: the radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose) as specified in 41.2(87).

Add the following new definitions:

“Air–purifying respirator” means a respirator with an air–purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air–purifying element.

“Assigned protection factor (APF)” means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

“Atmosphere–supplying respirator” means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied–air respirators (SRAs) and self–contained breathing apparatus (SCBA) units.

“Authorized medical physicist” means an individual who meets the requirements of 641—subrule 41.2(74) and 641— subrule 41.2(77) and is identified as an authorized medical physicist or teletherapy physicist on a specific medical license issued by this agency, the NRC, or an agreement state, a medical use permit issued by the NRC master material licensee, a permit issued by an NRC or agreement state broad scope medical use licensee, or a permit issued by an NRC master material license broad scope medical use permittee.

“Controlled area” means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

“Demand respirator” means an atmosphere–supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

“Disposable respirator” means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end–of–service–life renders it unsuitable for use. Examples of this type of respirator are a disposable half–mask respirator or a disposable escape–only self–contained breathing apparatus (SCBA).

“Filtering facepiece (dust mask)” means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, which is not equipped with elastomeric sealing surfaces and adjustable straps.

“Fit factor” means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

“Fit test” means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

“Helmet” means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

“Hood” means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

“Loose–fitting facepiece” means a respiratory inlet covering that is designed to form a partial seal with the face.

“Negative pressure respirator (tight fitting)” means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

“Positive pressure respirator” means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

“Powered air–purifying respirator (PAPR)” means an air–purifying respirator that uses a blower to force the ambient air through air–purifying elements to the inlet covering.

“Pressure demand respirator” means a positive pressure atmosphere–supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

“Qualitative fit test (QLFT)” means a pass–fail fit test to assess the adequacy of respirator fit that relies on the individual’s response to the test agent.

“Quantitative fit test (QNFT)” means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

“Self–contained breathing apparatus (SCBA)” means an atmosphere–supplying respirator for which the breathing air source is designed to be carried by the user.

“Supplied–air respirator (SRA)” or “airline respirator” means an atmosphere–supplying respirator for which the source of breathing air is not designed to be carried by the user.

“Tight–fitting facepiece” means a respiratory inlet covering that forms a complete seal with the face.

“Treatment site” means the anatomical description of the tissue intended to receive a radiation dose, as described in the written directive.

“User seal check (fit check)” means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

ITEM 3. Amend subrule 39.1(3) as follows:

39.1(3) All references to any Code of Federal Regulations (CFR) in this chapter are those in effect as of July 1, 2002 January 1, 2003.

ITEM 4. Amend subrule 39.4(20), paragraph “a,” as follows:

a. General licenses provided in this chapter are effective without the filing of applications with the agency or the issuance of licensing documents to the particular persons, although the filing of a certificate or registration application with the agency may be required by the particular general license. The general licensee is subject to all other applicable portions of these rules and any limitations of the general license.

ITEM 5. Amend subrule 39.4(22), introductory paragraph, as follows:

39.4(22) General licenses-radioactive material other than source material. This subrule establishes general licenses for the possession and use of radioactive material and a general license for ownership of radioactive material. (Note: Different general licenses are issued in this subrule, each of which has its own specific conditions and requirements.)

ITEM 6. Rescind paragraph 39.4(22)“d” and adopt the following new paragraph in lieu thereof:

d. Certain detecting, measuring, gauging, or controlling devices and certain devices for producing light or an ionized atmosphere.

(1) A general license is hereby issued to commercial and industrial firms and research, educational and medical institutions, individuals in the conduct of their business, and federal, state or local government agencies to acquire, receive, possess, use or transfer, in accordance with the provisions of 39.4(22)“d”(2), (3), and (4), radioactive material contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

(2) The general license in 39.4(22)“d”(1) applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license by this agency issued under 39.4(29)“d”; or an equivalent specific license issued by the NRC or an agreement state or a licensing state, which authorizes distribution of the devices. The devices must have been received from one of the specific licensees described in 39.4(22)“d”(2) or through a transfer made under 39.4(22)“d”(3).

(3) Any person who acquires, receives, possesses, uses or transfers radioactive material in a device pursuant to the general license in 39.4(22)“d”(1):

1. Shall ensure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited are maintained thereon and shall comply with all instructions and precautions provided by such labels;

2. Shall ensure that the device is tested for leakage of radioactive material and proper operation of the on–off mechanism and indicator, if any, at no longer than six–month intervals or at such other intervals as are specified in the label;

However,

• Devices containing only krypton need not be tested for leakage of radioactive material; and

• Devices containing only tritium or not more than 100 microcuries of other beta– or gamma–emitting material or both or 10 microcuries of alpha–emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose;

3. Shall ensure that the test required by 39.4(22)“d”(3) and other testing, installation, servicing, and removal from installation involving the radioactive material, its shielding or containment are performed:

• In accordance with the instructions provided by the labels; or

• By a person holding a specific license pursuant to 641-39.4(136C), the NRC, an agreement state or a licensing state to perform such activities;

4. Shall maintain records showing compliance with the requirements of 39.4(22)“d”(3). The records must show the results of tests. The records also must show the dates of performance of, and the names of persons performing, testing, installing, servicing, and removing from the installation radioactive material and its shielding or containment. The licensee shall retain these records as follows:

• Each record of a test for leakage or radioactive material required by 39.4(22)“d”(3) must be retained for three years after the next required leak test is performed or until the sealed source is transferred or disposed of;

• Each record of a test of the on–off mechanism and indicator required by 39.4(22)“d”(3) must be retained for three years after the next required test of the on–off mechanism and indicator is performed or until the sealed source is transferred or disposed of;

• Each record that is required by 39.4(22)“d”(3) must be retained for three years from the date of the recorded event or until the device is transferred or disposed of;

5. Shall immediately suspend operation of the device if there is a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on–off mechanism or indicator, or upon the detection of 0.005 microcurie (185 Bq) or more removable radioactive material. The device may not be operated until it has been repaired by the manufacturer or other person holding a specific license to repair such devices that was issued by this agency, the NRC, an agreement state or licensing state. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the radioactive material in the device or as otherwise approved by this agency. A report containing a brief description of the event and the remedial action taken, and in the case of detection of 0.005 microcurie (185 Bq) or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be furnished to the agency within 30 days. Under these circumstances, the criteria set out in 641-40.29(136C) may be applicable, as determined by the agency on a case–by–case basis;

6. Shall not abandon the device containing radioactive material;

7. Shall not export the device containing radioactive material except in accordance with 10 CFR Part 110;

8. Shall transfer or dispose of the device containingradioactive material only by export as provided by 39.4(22)“d”(3)“7,” by transfer to another general licensee as authorized in 39.4(22)“d”(3)“9,” to a person authorized to receive the device by a specific license issued by the agency, the NRC, an agreement state or a licensing state whose specific license authorizes the person to receive the device or which authorizes waste collection, or as otherwise approved under 39.4(22)“d”(3):

• Shall furnish a report to this agency within 30 days after the transfer of a device to a specific licensee or export. The report must contain the identification of the device by manufacturer’s (or initial transferor’s) name, model number, and serial number; the name, address and license number of the person receiving the device (license number not applicable if exported); and the date of the transfer;

• Shall obtain written agency approval before transferring the device to any other specific licensee not specifically identified in 39.4(22)“d”;

9. Shall transfer the device to another general licensee only if:

• The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of these rules and any safety documents identified in the label of the device. Within 30 days of the transfer, the transferor shall report to this agency the manufacturer’s (or initial transferor’s) name; the model number and the serial number of the device transferred; the transferee’s name and mailing address for the location of use; and the name, title, and telephone number of the responsible individual identified by the transferee in accordance with 39.4(22)“d”(3)“12” to have knowledge of and authority to take actions to ensure compliance with the appropriate rules and requirements; or

• The device is held in storage, by an intermediate person, in the original shipping container at its intended location of use prior to initial use by a general licensee;

10. Shall comply with the provisions of 641- 40.95(136C) and 641—40.96(136C), but shall be exempt from the other requirements of 641—Chapter 40;

11. Shall respond to written requests from this agency to provide information relating to the general license within 30 calendar days of the date of the request, or other item specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by submitting a letter to the agency and providing written justification as to why it cannot comply;

12. Shall appoint an individual responsible for having knowledge of the appropriate rules and requirements and the authority for taking required actions to comply with appropriate rules and requirements. The general licensee, through this individual, shall ensure the day–to–day compliance with appropriate rules and requirements. This appointment does not relieve the general licensee of any of its responsibility in this regard;

13. Shall register as follows:

• Shall register devices containing at least 10 mCi (370 MBq) of cesium–137, 0.1 mCi (3.7 MBq) of strontium–90,1 mCi (37 MBq) of cobalt–60, 1 mCi (37 MBq) ofamericium–241, .01 mCi (.37 MBq) of radium–226, or any other transuranic (i.e., element with atomic number greater than uranium (92)), or 1000 times the activity indicated in Appendix B of 641—Chapter 39 (excluding hydrogen–3), based on the activity indicated on the label. Each address for a location of use, as described in 39.4(22)“d”(3)“13,” represents a separate general licensee and requires a separate registration and fee;

• If in possession of devices meeting the criteria of 39.4(22)“d”(3)“13,” shall register these devices annually with the agency and shall pay the fee required in 641—paragraph 38.8(2)“c.” Registration must be done by verifying, correcting, and adding to the information provided in a request for registration received from the agency. The registration information must be submitted 30 days from the date of the request for registration or as otherwise indicated in the request. In addition, a general licensee holding devices meeting the criteria of 39.4(22)“d”(3)“13” is subject to the bankruptcy notification requirement of 39.4(32)“e”;

• In registering devices, the general licensee shall furnish the following information and any other information specifically requested by the agency:

—Name and mailing address of the general licensee;

—Information about each device: the manufacturer (or initial transferor), model number, serial number, the radioisotope and activity (as indicated on the label);

—Name, title, and telephone number of the responsible person designated as a representative of the general licensee;

—Address or location at which the device(s) is both used and stored. For portable devices, the address of the primary place of storage;

—Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and check of label information.

—Certification by the responsible representative of the general licensee that the licensee is aware of the requirements of the general license.

• Persons generally licensed by this agency under 39.4(22)“d”(3)“13” or an agreement state are not subject to registration requirements of the NRC if the devices are used in areas subject to NRC jurisdiction for a period of less than 180 days in any calendar year. The NRC will not request registration information from such licensees;

14. Shall report changes to the mailing address for the location of use (including change in name of general licensee) to the agency within 30 days of the effective date of the change. For a portable device, a report of address change is only required for a change in the device’s primary place of storage; and

15. May not hold devices that are not in use for longer than two years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by 39.4(22)“d” need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two–year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.

(4) The general license in 39.4(22)“d”(1) does not authorize the manufacture or import of devices containing radioactive material.

ITEM 7. Amend subrule 39.4(29), paragraph “d,” as follows:

Amend subparagraph (1) as follows:

Amend the introductory paragraph as follows:

(1) An application for a specific license to manufacture or distribute initially transfer devices containing radioactive material, excluding special nuclear material, to persons generally licensed under 39.4(22)“d” or equivalent regulations of the NRC, an agreement state, or a licensing state will be approved if:

Amend numbered paragraph “2,” second bullet point, as follows:

• Under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in any period of 1 calendar quarter one year a dose in excess of 10 percent of the annual limits specified in 641-40.15(136C); and

Amend numbered paragraph “3,” introductory paragraph, as follows:

3. Each device bears a durable, legible, clearly visible label or labels approved by the agency, NRC, or agreement state or licensing state, which contains in a clearly identified and separate statement:

Amend numbered paragraph “3,” third bullet point, as follows:

• The information called for in one of the following statements, as appropriate, in the same or substantially similar form:

The receipt, possession, use and transfer of this device, Model ________, Serial No. _____, (devices licensed prior to January 19, 1975, may bear labels authorized by the rules in effect on January 1, 1975)(the model, serial number, and name of the manufacturer or distributor initial transferor may be omitted from the label provided the information is elsewhere specified in labeling affixed to the device) are subject to a general license or the equivalent and the chapter of the U.S. Nuclear Regulatory Commission or a state with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION-RADIOACTIVE MATERIAL

______________________________

Name of manufacturer or distributor

Adopt new numbered paragraphs “4” and “5” as follows:

4. Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words “Caution—Radioactive Material,” the radiation symbol described in 641—subrule 40.60(1), and the name of the manufacturer or initial distributor; and

5. Each device meeting the criteria of 39.4(22)“d”(3)“13” bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, “Caution—Radioactive Material,” and, if practicable, the radiation symbol described in 641—subrule 40.60(1).

Amend subparagraph (3) as follows:

(3) In the event the applicant desires that the general licensee under 39.4(22)“d,” or under equivalent regulations of the U.S. Nuclear Regulatory Commission NRC, an agreement state, or a licensing state be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the “on–off” mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and bases for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a calendar quarter dose in excessof 10 percent of the annual limits specified in 641- 40.15(136C).

ITEM 8. Rescind subparagraph 39.4(29)“d”(4) and adopt the following new subparagraphs (4), (5), and (6) in lieu thereof:

(4) Information to be provided before transfer.

1. If a device containing radioactive material is to be transferred for use under the general license contained in 39.4(22)“d,” each person that is licensed under 39.4(22)“d” shall provide the information specified to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:

• A copy of the general license contained in 39.4(22), or if 39.4(22)“d”(3)“2,” “3,” or “4” or 39.4(22)“d”(3)“13”does not apply to the particular device, those paragraphs may be omitted;

• A copy of 39.4(20), 39.4(52), 641—40.95(136C), and 641—40.96(136C);

• A list of the services that can only be performed by a specific licensee;

• Information on acceptable disposal options including estimated costs of disposal; and

• An indication that it is the policy of the NRC and this agency to issue high civil penalties for improper disposal.

2. If radioactive material is to be transferred in a device for use under an equivalent general license of an agreement state, each person that is licensed under 39.4(29)“d” shall provide the information specified in this paragraph to each person to whom a device is to be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:

• A copy of the agreement state’s rules equivalent to 39.4(29)“d.” If a copy of the NRC regulations is provided to a prospective general licensee in lieu of the agreement state’s regulations, it shall be accompanied by a note explaining that use of the device is regulated by the agreement state; if certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted;

• A list of the services that can only be performed by a specific licensee;

• Information on acceptable disposal options including estimated costs of disposal; and

• The name or title, address, and telephone number of the contact at the agreement state regulatory agency from which additional information may be obtained.

3. An alternative approach to informing customers may be proposed by the licensee for approval by the agency.

4. Each device that is transferred after February 19, 2002, must meet the labeling requirements in 39.4(29)“d.”

5. If a notification of bankruptcy has been made or the license is to be terminated, each person licensed under 39.4(29)“d” shall provide, upon request, to the NRC and to any appropriate agreement state, records of final disposition.

(5) Transfer reports and records. Each person licensed under 39.4(29)“d” to initially transfer devices to generally licensed persons shall comply with the requirements of this subparagraph.

1. The person shall report all transfers of devices to persons for use under the general license in 39.4(29)“d” and all receipts of devices from persons licensed under 39.4(29)“d” to the NRC, this agency, or another agreement state. The report must be submitted on a quarterly basis in a clear and legible report containing all of the data required in this subrule. The required information for transfers to general licensees includes:

• The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use;

• The name, title, and telephone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate rules and requirements;

• The date of transfer;

• The type, model number, and serial number of the device transferred; and

• The quantity and type of radioactive material contained in the device.

2. If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).

3. For devices received from a general licensee, the report must include the identity of the general licensee by name and address; the type, model number, and serial number of the device received; the date of receipt; and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

4. If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update the required information, the report must identify the general licensee, the device, and the changes to information on the device label.

5. The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

6. The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

7. If no transfers have been made to or from persons generally licensed under 39.4(29)“d” during the reporting period, the report must so indicate.

(6) The person shall maintain all information concerning transfers and receipts of devices that supports the reports required by 39.4(29)“d.” Records required in 39.4(29)“d” must be maintained for three years following the date of the recorded event.

ITEM 9. Amend subrule 40.1(5) as follows:

40.1(5) All references to Code of Federal Regulations (CFR) in this chapter are those in effect on or before May 9, 2001 January 1, 2003.

ITEM 10. Amend subrule 40.2(2), definitions of “class” and “declared pregnant woman,” as follows:

“Class (or lung class or inhalation class)” means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half–times: for Class D, Days, of less than 10 days, for Class W, Weeks, from 10 to 100 days, and for Class Y, Years, of greater than 100 days. For purposes of these rules, “lung class” and “inhalation class” are equivalent terms.

“Declared pregnant woman” means a woman who has voluntarily informed her employer licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

ITEM 11. Amend subrule 40.15(1), paragraph “b,” as follows:

b. The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities which are:

(1) A lens dose equivalent of 15 rem (0.15 Sv); and

(2) A shallow dose equivalent of 50 rem (0.5 Sv) to the skin of the whole body or to the skin of any extremity.

ITEM 12. Amend subrule 40.15(3), introductory paragraph, as follows:

40.15(3) The assigned deep dose equivalent and shallow dose equivalent shall must be for the portion of the body receiving the highest exposure determined as follows: . The assigned shallow–dose equivalent must be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest exposure.

ITEM 13. Amend subrule 40.26(2) as follows:

40.26(2) If the licensee or registrant permits members of the public to have access to restricted controlled areas, the limits for members of the public continue to apply to those individuals.

ITEM 14. Adopt new subrule 40.26(6) as follows:

40.26(6) Notwithstanding the requirements of 40.26(1)“a,” a licensee may permit visitors to an individual who cannot be released under 641—subrule 41.2(27) to receive a radiation dose greater than 0.1 rem (1 mSv) if:

a. The radiation dose received does not exceed 0.5 rem (5 mSv); and

b. The authorized user, as defined in 641—subrule 41.2(2), has determined before the visit that it is appropriate.

ITEM 15. Rescind subrule 40.36(5) and adopt the following new subrule in lieu thereof:

40.36(5) After replacement, each personnel dosimeter must be sent for processing as soon as possible.

ITEM 16. Amend rule 641-40.48(136C) as follows:

641-40.48(136C) Use of process or other engineering controls. The licensee shall use, to the extent practical, proc–ess or other engineering controls, such as containment, decontamination, or ventilation, to control the concentrations of radioactive material in air.

ITEM 17. Amend rule 641-40.49(136C) as follows:

40.49(1) When it is not practical to apply process or other engineering controls to control the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the licensee shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means:

40.49(1) a. Control of access; or

40.49(2) b. Limitation of exposure times; or

40.49(3) c. Use of respiratory protection equipment; or

40.49(4) d. Other controls.

ITEM 18. Amend subrule 40.50(1) as follows:

40.50(1) If the licensee uses assigns or permits the use of respiratory protection equipment to limit intakes pursuant to 40.49(136C):

a. Except as provided in 40.50(1), the The licensee shall use only respiratory protection equipment that is tested and certified or had certification extended by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration. (NIOSH), except as otherwise noted in this subrule.

b. If the licensee wishes to use equipment that has not been tested or certified by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration has not had certification extended by the National Institute for Occupational Safety and Health and the Mine Safety and Health Administration, or for which there is no schedule for testing or certification, the licensee shall submit an application for authorized use of that equipment, including a demonstration by testing, or a demonstration on the basis of reliable test information, that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use.

c. The licensee or registrant shall implement and maintain a respiratory protection program that includes:

(1) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate exposures; and

(2) Surveys and bioassays, as appropriate, to evaluate actual intakes; and

(3) Testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately prior to each use; and

(4) Written procedures regarding selection, fitting, issuance, maintenance, and testing of respirators, including testing for operability immediately prior to each use; supervision and training of personnel; monitoring, including air sampling and bioassays; and record keeping; and monitoring, including air sampling and bioassays; supervision and training of respirator user; fit testing; respirator selection; breathing air quality; inventory and control; storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment; record keeping; and limitations on periods of respirator use and relief from respirator use;

(5) Determination by a physician prior to initial fitting of respirators, and either every 12 months thereafter, or periodically at a frequency determined by a physician, that the individual user is medically fit to use the respiratory protection equipment. that the individual user is medically fit to use respiratory protection equipment: before the initial fitting of a face–sealing respirator; before the first field use of non–face–sealing respirators; and either every 12 months thereafter, or periodically at a frequency determined by a physician; and

e d. The licensee shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.

g. Atmosphere–supplying respirators must be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G–7.1, “Commodity Specification for Air,” 1997, and included in the regulations of the Occupational Safety and Health Administration (29 CFR 1910.134(i)(1)(ii)(A) through (E)). Grade D quality air criteria include:

ITEM 19. Amend subrule 40.50(4) as follows:

40.50(4) Further restrictions.

a. The licensee shall notify the agency in writing at least 30 days before the date that respiratory protection equipment is first used pursuant to either 40.50(1) or 40.50(2).

b. The agency may impose restrictions in addition to those listed in these rules in order to limit individual exposures.:

ITEM 20. Adopt new rule 641-40.117(136C) as follows:

40.117(1) Discrimination by a licensee or registrant, an applicant for a license or registration, or a contractor or subcontractor of a licensee or applicant against an employee for engaging in certain protected activities is prohibited. Discrimination includes discharge and other actions that relate to compensation, terms, conditions, or privileges of employment. The protected activities are established in 641— Chapters 38 to 45, and in general are related to the administration or enforcement of requirements imposed under 641—Chapters 38 to 45.

a. The protected activities include but are not limited to:

(1) Providing the agency or the individual’s employer information about alleged violations of either of the statutes named in this rule or possible violations of requirements imposed under either of those statutes:

(2) Refusing to engage in any practice made unlawful under either of the statutes named in this rule or under these requirements if the employee has identified the alleged illegality to the employer;

(3) Requesting that the agency institute action against the individual’s employer for the administration or enforcement of these requirements;

(4) Testifying in any agency proceeding, or before Congress, or at any federal or state proceeding regarding any provision (proposed provision) of federal statutes or these rules;

(5) Assisting or participating in, or about to assist or participate in, these activities.

b. These activities are protected even if no formal proceeding is actually initiated as a result of the employee’s assistance or participation.

c. This rule has no application to any employee alleging discrimination prohibited by this rule who, acting without direction from the individual’s employer (or the employer’s agent), deliberately causes a violation of any requirement of 641—Chapters 38 to 45.

40.117(2) Any employee who believes that the employee has been discharged or otherwise discriminated against by any person for engaging in protected activities specified in 40.117(1)“a” may seek a remedy for the discharge or discrimination through an administrative proceeding in the U.S. Department of Labor. The administration proceeding must be initiated within 180 days after an alleged violation occurs. The employee may file for the administrative proceeding by filing a complaint alleging the violation with the Department of Labor, Employment Standards Administration, Wage and Hour Division. The Department of Labor may order reinstatement, back pay, and compensatory damages.

40.117(3) A violation of 40.117(1)“a”(1) or 40.117(1)“a”(4) by a licensee or registrant, an applicant for a license or registration, or a contractor or subcontractor of a licensee or applicant may be grounds for:

a. Denial, revocation, or suspension of the license or registration.

b. Imposition of a civil penalty on the licensee, registrant, or applicant.

c. Other enforcement action.

40.117(4) Actions taken by an employer or others which adversely affect an employee may be predicated upon nondiscriminatory grounds. The prohibition applies when the adverse action occurs because the employee has engaged in protected activities. An employee’s engagement in protected activities does not automatically render the employee immune from discharge or discipline for legitimate reasons or from adverse action dictated by nonprohibited considerations.

40.117(5) No agreement affecting the compensation, terms, conditions, or privileges of employment, including an agreement to settle a complaint filed by an employee with the Department of Labor pursuant to 641—Chapters 38 to 45, may contain any provision which would prohibit, restrict, or otherwise discourage an employee from participating in protected activity as defined in 40.117(1)“a” including, but not limited to, providing information to the agency or to the individual’s employer on potential violations or other matters within the agency’s regulatory responsibilities.

ITEM 21. Amend subrule 41.2(1) as follows:

41.2(1) Purpose and scope.

a. This rule establishes requirements and provisions for the use of radionuclides in the healing arts and for issuance of licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The requirements and provisions of this rule are in addition to, and not in substitution for, the applicable portions of 641-Chapters 38 to 40. The requirements and provisions of these rules apply to applicants and licensees subject to this rule unless specifically exempted.

b. All references to any Code of Federal Regulations (CFR) in this chapter are those in effect as of July 1, 1998 January 1, 2003.

ITEM 22. Amend subrule 41.2(2) as follows:

Amend the following definitions:

“Authorized nuclear pharmacist” means a pharmacistwho has met the appropriate requirements of 41.2(77) and 41.2(78) and who is:

a. Is practicing nuclear pharmacy as authorized by a current Iowa radioactive materials license. ; or

“Authorized user” means a physician, dentist, or podiatrist who has met the appropriate requirements of 41.2(67), 41.2(68), 41.2(70), 41.2(71), 41.2(72), or 41.2(73) and who is identified on: uses radioactive materials as authorized by a current medical use Iowa radioactive materials license

4. A permit issued by an NRC master material license broad scope permittee that is authorized to permit medical use of radioactive material.

Adopt the following new definitions:

“Authorized medical physicist” means an individual who:

a. Meets the requirements of 41.2(74) and 41.2(77); or

b. Is identified as an authorized medical physicist or teletherapy physicist on:

1. A specific medical use license issued by this agency, the NRC, or an agreement state;

2. A medical use permit issued by an NRC master material licensee;

3. A permit issued by an NRC or agreement state broad scope medical use licensee; or

4. A permit issued by an NRC master material license broad scope medical use permittee.

“Radiation safety officer” means an individual who, in addition to the definition in 641—38.2(136C), meets the requirements of 41.2(65), 41.2(66), and 41.2(77) and is identified as a radiation safety officer on a specific medical use license issued by Iowa, the NRC, or agreement state or a medical use permit issued by an NRC master material licensee.

ITEM 23. Rescind subrule 41.2(10) and adopt the following new subrule in lieu thereof:

41.2(10) Authority and responsibilities for the radiation protection program.

a. In addition to the radiation protection program requirements of 641-40.10(136C), a licensee’s management shall approve in writing:

(1) Requests for a license application, renewal, or amendment before submittal to this agency;

(2) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and

(3) Radiation protection program changes that do not require a license amendment.

b. A licensee’s management shall appoint a radiation safety officer, who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the radiation safety officer, shall ensure that the radiation safety activities are being performed in accordance with licensee–approved procedures and regulatory requirements.

c. For up to 60 days each year, a licensee may permit an authorized user or an individual qualified to be a radiation safety officer under 41.2(65) or 41.2(66) to function as a temporary radiation safety officer to perform the functions of radiation safety officer, as provided in 41.2(10)“g,” if the licensee takes the actions required in 41.2(10)“b,” “e,” “g,” and “h” and notifies this agency in accordance with 41.2(5).

d. A licensee may simultaneously appoint more than one temporary radiation safety officer in accordance with 41.2(10)“c” if needed to ensure that the licensee has a temporary radiation safety officer who satisfies the requirements to be a radiation safety officer for each of the different types of by–product material permitted on the license.

e. A licensee shall establish the authority, duties, and responsibilities of the radiation safety officer in writing.

f. Licensees that are authorized for two or more different types of uses of radioactive materials or two or more types of units under this rule shall establish a radiation safety committee to oversee all uses of radioactive material permitted by the license.

g. A licensee shall provide the radiation safety officer sufficient authority, organizational freedom, time, resources, and management prerogative to:

(1) Identify radiation safety problems;

(2) Initiate, recommend, or provide corrective solutions;

(3) Verify implementation of corrective actions; and

(4) Stop unsafe operations.

h. A licensee shall retain a record of actions taken under 41.2(10) in accordance with 641-40.80(136C).

ITEM 24. Amend subrule 41.2(11), paragraph “a,” subparagraph (1), as follows:

(1) Instruct the supervised individual in the principles of radiation safety, written directive procedures, rules of this chapter, and license conditions appropriate to that individual’s use of radioactive material;

ITEM 25. Amend subrule 41.2(13) as follows:

Amend paragraph “b” as follows:

b. Mobile nuclear medicine service licensees shall retain for the duration of service a letter signed by the management of each location where services are rendered that authorizes use of radioactive material and clearly delineates the authority of the licensee and client.

Adopt new paragraph “e” as follows:

e. Mobile nuclear medicine service licensees shall also perform the following:

(1) Check instruments used to measure the activity of unsealed radioactive material for proper function before use at each client’s address or on each day of use, whichever is more frequent. At a minimum, the check for proper function required by this rule must include a constancy check;

(2) Check survey instruments for proper operation with a dedicated check source before use at each client’s address;

(3) Before leaving a client’s address, survey all areas of use to ensure compliance with the requirements of 641- Chapters 40 and 41.

ITEM 26. Amend subrule 41.2(14), catchwords and paragraph “a,” as follows:

41.2(14) Records and reports of misadministrations, and reportable events, and written directives.

a. When a misadministration or reportable medical event occurs, the licensee shall notify the agency by telephone. The licensee shall also notify the referring physician of the affected patient or human research subject and the patient or human research subject or a responsible relative or guardian, unless the referring physician agrees to inform the patient or human research subject or believes, based on medical judgment, that telling the patient or human research subject or the patient’s or human research subject’s responsible relative or guardian would be harmful to one or the other, respectively. These notifications must be made within 24 hours after the licensee discovers the misadministration or reportable medical event. If the referring physician, patient or human research subject, or the patient’s or human research subject’s responsible relative or guardian cannot be reached within 24 hours, the licensee shall notify them as soon as practicable. The licensee is not required to notify the patient or human research subject or the patient’s or human research subject’s responsible relative or guardian without first consulting the referring physician; however, the licensee shall not delay medical care for the patient or human research subject because of this notification requirement including remedial care as a result of the misadministration or reportable medical event because of any delay in notification.

ITEM 27. Amend subrule 41.2(14), paragraph “b,” subparagraph (1), as follows:

(1) The licensee shall submit a written report to the agency within 15 days after discovery of the misadministration and 30 days after discovery of a or reportable medical event. The written report must include the licensee’s name, the prescribing physician’s name, a brief description of the event, why the event occurred, the effect on the patient or the human research subject, what improvements are needed to prevent recurrence, actions taken to prevent recurrence, whether the licensee notified the patient or the human research subject or the patient’s or the human research subject’s responsible relative or guardian (this individual will subsequently be referred to as “the patient or the human research subject”), and if not, why not, and if the patient or the human research subject was notified, what information was provided to that individual. The report must not include the patient’s or the human research subject’s name or other information that could lead to identification of the patient or the human research subject.

ITEM 28. Amend subrule 41.2(14), paragraph “b,” subparagraph (2), introductory paragraph, as follows:

(2) If the patient or the human research subject was notified, the licensee shall also furnish, within 15 days after discovery of the misadministration or reportable medical event, a written report to the patient or the human research subject and the referring physician by sending either:

ITEM 29. Rescind subrule 41.2(14), paragraph “f.”

ITEM 30. Amend subrule 41.2(18), paragraph “c,” as follows:

c. To satisfy the requirements of 41.2(18)“b,” the licensee shall consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent and shall conspicuously attach a correction chart or graph to the instrument. A licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20 percent.

ITEM 31. Amend subrule 41.2(21), paragraph “e,” subparagraph (2), as follows:

(2) File a report with the agency within five days of receiving the leak test results. with the agency describing The report shall describe the equipment involved, the model and serial number of the leaking source, the radionuclide and its estimated activity, the test results, the date of the test, and the action taken.

ITEM 32. Amend subrule 41.2(26) by adopting new paragraph “i” as follows:

i. A licensee does not need to perform the surveys required in this subrule in an area where the patient or human research subject is confined and cannot be released under 41.2(27).

ITEM 33. Amend subrule 41.2(30), paragraph “a,” introductory paragraph, as follows:

a. A licensee may hold radioactive material with half–lives of less than 65 120 days, except for Cobalt–57 for decay–in–storage before disposal in ordinary trash and is exempt from the requirements of 641-subrule 40.70(1) if the licensee:

ITEM 34. Amend subrule 41.2(31) as follows:

41.2(31) Use of radiopharmaceuticals for uptake, dilution, or excretion studies. The Except for quantities that require a written directive under 41.2(87), a licensee may use for uptake, dilution, excretion and imaging studies any unsealed by–product material prepared for medical use that is either:

a. No change.

b. Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 41.2(67), or an individual under the supervision of either as specified in 41.2(11). ; or

ITEM 35. Amend subrule 41.2(33) as follows:

41.2(33) Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies. The Except for the quantities that require written directive under 41.2(87), a licensee may use for imaging and localization studies any unsealed by–product material prepared for medical use that is either:

a. Obtained from a manufacturer or preparer licensed pursuant to 641-paragraph 39.4(29)“j” or equivalent U.S. Nuclear Regulatory Commission NRC or agreement state requirements; or

b. Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 41.2(68), or an individual under the supervision of either as specified in 41.2(11). ;

ITEM 36. Rescind subrule 41.2(37) and adopt the following new subrule in lieu thereof:

41.2(37) Use of radiopharmaceuticals for therapeutic use or unsealed by–product material for which a written directive is required. Material must be:

a. Obtained from a manufacturer or preparer licensed by the NRC or an agreement state to manufacture and prepare by–product material for medical use; or

b. Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements of 41.2(68) or 41.2(69), or an individual under the supervision of either as specified in 41.2(11); or

c. Obtained from and prepared by an NRC or agreement state licensee for use in research in accordance with the Investigational New Drug (IND) protocol accepted by FDA; or

d. Prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.

ITEM 37. Amend subrule 41.2(38), paragraph “a,” as follows:

a. A licensee shall provide oral and written radiation safety instruction for all personnel caring for patients or human research subjects undergoing radiopharmaceutical therapy and hospitalized in compliance with 41.2(27). Refresher training shall be provided at intervals not to exceed one year.

ITEM 38. Amend subrule 41.2(38), paragraph “b,” subparagraph (5), as follows:

(5) Notification of the radiation safety officer, radiation safety officer designee, or authorized user in case of the patient’s or human research subject’s death or medical emergency; and

ITEM 39. Amend subrule 41.2(39), paragraph “a,” subparagraph (1), as follows:

(1) Provide a private room with a private sanitary facility or a room, with a private sanitary facility, with another individual who also has received therapy with unsealed radioactive material and who also cannot be released under 41.2(27);

ITEM 40. Rescind subrule 41.2(41) and adopt the following new subrule in lieu thereof:

41.2(41) Use of sealed sources for diagnosis. A licensee shall use only sealed sources for diagnostic medical uses as approved in the Sealed Source and Device Registry.

ITEM 41. Rescind subrule 41.2(43) and adopt the following new subrule in lieu thereof:

41.2(43) Use of sources for brachytherapy. A licensee shall use only brachytherapy sources for therapeutic medical uses:

a. As approved in the Sealed Source and Device Registry; or

b. In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 41.2(15) are met.

ITEM 42. Amend subrule 41.2(44), paragraph “b,” subparagraphs (4) and (5), as follows:

(4) Procedures for visitor control, to include routine visitation of hospitalized individuals in accordance with 641- 40.26(136C) and visitation authorized in accordance with 641- 40.26(136C);

(5) Procedures for notification of the radiation safety officer, radiation safety officer designee, or authorized user if the patient or human research subject dies or has a medical emergency; and

ITEM 43. Amend subrule 41.2(45), paragraph “a,” by adopting new subparagraph (6) as follows:

(6) Have applicable emergency response equipment available near each treatment room to respond to a source dislodged from the patient or lodged within the patient following removal of the source applicators.

ITEM 44. Amend subrule 41.2(45), paragraph “b,” as follows:

b. A licensee shall notify the radiation safety officer, radiation safety officer designee, or authorized user immediately if the patient or human research subject dies or has a medical emergency.

ITEM 45. Amend subrule 41.2(46) by adopting new paragraph “e” as follows:

e. A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use. As soon as possible after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area.

ITEM 46. Amend subrule 41.2(47), paragraph “a,” as follows:

a. Immediately after removing the last temporary implant source from a patient or human research subject, the licensee shall perform a radiation survey of the patient or human research subject with a radiation detection survey instrument to confirm that all sources have been removed and, for remote afterloaders, returned to the safe shielded position. The licensee shall not release from confinement for medical care a patient or human research subject treated by temporary implant until all sources have been removed.

ITEM 47. Rescind subrule 41.2(49) and adopt the following new subrule in lieu thereof:

41.2(49) Use of sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit. A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses as approved in the Sealed Source and Device Registry or in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 41.2(15) are met.

ITEM 48. Rescind subrule 41.2(50) and adopt the following new subrule in lieu thereof:

41.2(50) Installation, maintenance, adjustment, and repair.

a. Only a person specifically licensed by the NRC or an agreement state shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), or the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

b. Except for low–dose–rate remote afterloader units, only a person specifically licensed by the NRC or an agreement state shall install, replace, relocate, or remove a sealed source or source contained in other remote units, teletherapy units, or gamma stereotactic radiosurgery units.

c. For low–dose–rate remote afterloader units, only a person specifically licensed by the NRC or an agreement state or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.

d. A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader teletherapy units and gamma stereotactic radiosurgery units for three years. The record must include the date, description of the service, and the name of the individual who performed the work.

ITEM 49. Rescind subrule 41.2(52) and adopt the following new subrule in lieu thereof:

41.2(52) Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

a. A licensee shall:

(1) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

(2) Permit only individuals approved by the authorized user, radiation safety officer, or authorized medical physicist to be present in the treatment room during treatment with the source;

(3) Prevent dual operation of more than one radiation producing device in a treatment room, if applicable; and

(4) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source in the shielding position, or to remove the patient or human research subject from the field with controls from outside the treatment room. These procedures must include:

1. Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;

2. The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

3. The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the unit or console operates abnormally.

b. A copy of the procedures required by 41.2(52)“a”(4) must be physically located at the unit console.

c. A licensee shall post instructions at the unit console to inform the operator of:

(1) The location of the procedures required by 41.2(52)“a”(4); and

(2) The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the unit or console operates abnormally.

d. A licensee shall provide instruction, initially and at least annually, to all individuals who operate the unit, appropriate to the individual’s assigned duties, in:

(1) The procedures identified in 41.2(52)“a”(4); and

(2) The operating procedures for the unit.

e. The licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of emergency procedures, initially and at least annually.

f. A licensee shall retain a record for three years of individuals receiving instruction required by 41.2(52)“d,” adescription of the instruction, the date of instruction, andthe name of the individual who gave the instruction. A copy of the procedures required in 41.2(52)“a”(4) and 41.2(52)“d”(2) shall be retained for three years.

ITEM 50. Amend subrule 41.2(53) as follows:

Amend the introductory paragraph as follows:

41.2(53) Doors, interlocks, and warning systems. Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

Rescind paragraph “c” and adopt new paragraphs “c” to “g” as follows:

c. A licensee shall require any individual entering the treatment room to ensure, through the use of appropriate monitors, that radiation levels have returned to ambient levels.

d. Except for low–dose–rate remote afterloader units, a licensee shall construct or equip each treatment room with intercom systems to permit continuous observation of the patient or human research subject from the treatment console during irradiation.

e. For licensed activities where sources are placed within the patient’s or human research subject’s body, the licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source.

f. In addition to the requirements specified in 41.2(53)“a” through “e,” a licensee shall:

(1) For medium–dose–rate and pulsed–dose–rate remote afterloader units, require:

1. An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who have been trained in the operation of and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit; and

2. An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who have been trained to remove the source applicator in the event of an emergency involving the unit to be immediately available during continuation of all patient treatments involving the unit.

(2) For high–dose–rate remote afterloader units, require:

1. An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and

2. An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who have been trained in the operation and emergency response for the unit, to be physically present during the continuation of all patient treatments involving the unit.

(3) For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist be physically present throughout all patient treatments involving the unit.

(4) Notify the radiation safety officer, or the radiation safety officer designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

g. A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source remaining in the unshielded position or lodged within the patient following completion of the treatment.

ITEM 51. Amend subrule 41.2(57), paragraph “a,” as follows:

a. A Except for low–dose–rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions shall be met:

(1) The system shall have been calibrated by using a system or source traceable to the National Institute of Standards and Technology and published protocols accepted by nationally recognized bodies, or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The calibration shall have been performed within the previous two years and after any servicing that may have affected system calibration; or

(2) The system shall have been calibrated within the previous four years; 18 to 30 months after that calibration, the system shall have been intercompared at an inter–comparison meeting with another dosimetry system that was calibrated within the past 24 months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine. The intercomparison meeting shall be sanctioned by a calibration laboratory or radiologic physics center accredited by the American Association of Physicists in Medicine. The results of the intercomparison meeting must have indicated that the calibration factor of the licensee’s system had not changed by more than 2 percent. The licensee shall not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be usedfor calibrating cobalt–60 teletherapy units, the licensee shall use a teletherapy unit with a cobalt–60 source. When intercomparing dosimetry systems to be used for calibratingcesium–137 teletherapy units, the licensee shall use a teletherapy unit with a cesium–137 source sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, if applicable, and sources of the same radionuclide as the source used at the licensee’s facility.

ITEM 52. Rescind subrule 41.2(58) and adopt the following new subrule in lieu thereof:

41.2(58) Full calibration measurements on teletherapy units, remote afterloader units, and gamma stereotactic radiosurgery units.

a. Teletherapy units.

(1) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements for each teletherapy unit:

1. Before the first medical use of the unit; and

2. Before medical use under the following conditions:

• Whenever spot–check measurements indicate that the output differs by more than 5 percent from the output of the last full calibration corrected mathematically for radioactive decay;

• Following replacement of the source or following reinstallation of the teletherapy unit in a new location;

• Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

3. At intervals not exceeding one year.

(2) To satisfy the requirements of 41.2(58)“a”(1), full calibration measurements must include determination of:

1. The output within ±3 percent for the range of field sizes and for the distance or range of distances used for medical use;

2. The coincidence of the radiation field and the field indicated by the light beam localizing device;

3. The uniformity of the radiation field and its dependence on the orientation of the useful beam;

4. Timer accuracy and linearity over the range of use;

5. On–off error; and

6. The accuracy of all distance measuring and localization devices in medical use.

(3) A licensee shall use the dosimetry system described in 41.2(57) to measure the output for one set of exposure conditions. The remaining radiation measurements required in 41.2(58)“a”(2)“1” may be made using the dosimetry system that indicates relative dose rates.

(4) A licensee shall make full calibration measurements required by 41.2(58)“a” in accordance with published protocols accepted by nationally recognized bodies.

(5) A licensee shall mathematically correct the outputs determined in 41.2(58)“a”(2)“1” for physical decay for intervals not exceeding one month for cobalt–60, six months for cesium–137, or at intervals consistent with 1 percent of all other radionuclides.

(6) Full calibration measurements required by 41.2(58)“a”(1) and physical decay corrections required in 41.2(58)“a”(5) must be performed by the authorized medical physicist.

(7) A licensee shall maintain a record of each calibration for the duration of the license. The record shall include the date of the calibration; the manufacturer’s name, model number, and serial number for both the unit and the source; tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy; a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device; the measured timer accuracy for a typical treatment time; the calculated “on–off” error; the estimated accuracy of each distance measuring or localization device; and the signature of the authorized medical physicist.

b. Remote afterloader units.

(1) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements for each unit:

1. Before the first medical use of the unit; and

2. Before medical use under the following conditions:

• Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and

• Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

3. At intervals not exceeding one quarter of a year for high–dose–rate, medium–dose–rate, and pulsed–dose–rate remote afterloader units with sources whose half–life exceeds 75 days; and

4. At intervals not exceeding one year for low–dose–rate remote afterloader units.

(2) To satisfy the requirements of 41.2(58)“b”(1), full calibration measurements must include, as applicable, determination of:

1. The output within ±5 percent;

2. Source positioning accuracy to within ±1 millimeter;

3. Source retraction with backup battery upon power failure;

4. Length of the source transfer tubes;

5. Timer accuracy and linearity over the typical range of use;

6. Length of the applicators; and

7. Function of the source transfer tubes, applicators, and transfer tube–applicator interfaces.

(3) A licensee shall use the dosimetry system described in 41.2(57) to measure the output.

(4) A licensee shall make full calibration measurements required by 41.2(58)“b”(1) in accordance with published protocols accepted by nationally recognized bodies.

(5) In addition to the requirements for full calibrations for low–dose–rate remote afterloader units in 41.2(58)“b”(2), a licensee shall perform an autoradiograph of the source to verify inventory and source arrangement at intervals not exceeding one quarter of a year.

(6) For low–dose–rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with 41.2(58)“b.”

(7) A licensee shall mathematically correct the outputs determined in 41.2(58)“b”(2)“1” for physical decay intervals consistent with 1 percent physical decay.

(8) Full calibration measurements required by 41.2(58)“b”(1) and physical decay corrections required by 41.2(58)“b”(7) must be performed by the authorized medical physicist.

(9) A licensee shall retain a record of each calibration in accordance with 41.2(58)“a”(7).

c. Gamma stereotactic radiosurgery units.

(1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:

1. Before the first medical use of the unit;

2. Before medical use under the following conditions:

• Whenever spot–check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

• Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

• Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and

3. At intervals not exceeding one year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

(2) To satisfy the requirement of 41.2(58)“c”(1), full calibration measurements must include determination of:

1. The output within ±3 percent;

2. Relative helmet factors;

3. Isocenter coincidence;

4. Timer accuracy and linearity over the range of use;

5. On–off error;

6. Trunnion centricity;

7. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

8. Helmet microswitches;

9. Emergency timing circuits; and

10. Stereotactic frames and localizing devices (trunnions).

(3) A licensee shall use the dosimetry system described in 41.2(57) to measure the output for one set of exposure conditions. The remaining radiation measurements required in 41.2(58)“c”(2)“1” may be made using a dosimetry system that indicates relative dose rates.

(4) A licensee shall make full calibration measurements required by 41.2(58)“c”(1) in accordance with published protocols accepted by nationally recognized bodies.

(5) A licensee shall mathematically correct the outputs determined in 41.2(58)“c”(2)“1” at intervals not exceeding one month for cobalt–60 and at intervals consistent with1 percent physical decay for all other radionuclides.

(6) Full calibration measurements required by 41.2(58)“c”(1) and physical decay corrections required in 41.2(58)“c”(5) must be performed by the authorized medical physicist.

(7) A licensee shall retain a record of each calibration in accordance with 41.2(58)“a”(7).

ITEM 53. Rescind subrule 41.2(59) and adopt the following new subrule in lieu thereof:

41.2(59) Periodic spot checks for teletherapy units, remote afterloader units, and gamma stereotactic radiosurgery units.

a. Teletherapy units.

(1) A licensee authorized to use teletherapy units for medical use shall perform output spot checks on each teletherapy unit once in each calendar month that include determination of:

1. Timer accuracy and timer linearity over the range of use;

2. On–off error;

3. The coincidence of the radiation field and the field indicated by the light beam localizing device;

4. The accuracy of all distance measuring and localization devices used for medical use;

5. The output for one typical set of operating conditions measured with the dosimetry system described in 41.2(57); and

6. The difference between the measurement made in 41.2(59)“a”(1)“5” and the anticipated output expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).

(2) A licensee shall perform measurements required by 41.2(59)“a”(1) in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot–check measurements.

(3) A licensee shall have the authorized medical physicist review the results of each spot check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the result of each spot check.

(4) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot checks of each teletherapy facility once in each calendar month and after each source installation to ensure proper operation of:

1. Electrical interlocks at each teletherapy room entrance;

2. Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on–off mechanism);

3. Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;

4. Viewing and intercom systems;

5. Treatment room doors from inside and outside the treatment room; and

6. Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

(5) If the results of the spot checks required in 41.2(59)“a”(4) indicate the malfunction of any system, the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(6) A licensee shall retain for three years a record of each spot check required in 41.2(59)“a.” The record must include:

1. The date of the spot check;

2. The manufacturer’s name, model number, and serial number of the teletherapy unit, source and instrument used to measure the output of the teletherapy unit;

3. An assessment of timer linearity and constancy;

4. The calculated on–off error;

5. A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device;

6. The determined accuracy of each distance measuring and localization device;

7. The difference between the anticipated output and the measured output;

8. Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical source exposure indicator light, and the viewing and intercom system and doors; and

9. The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check.

(7) A licensee shall retain a copy of the procedures required by 41.2(59)“b” until the licensee no longer possesses the teletherapy unit.

b. Remote afterloader units.

(1) A licensee authorized to use a remote afterloader unit for medical use shall perform spot checks of each remote afterloader facility and on each unit:

1. Before the first use of a high–dose–rate, medium–dose–rate, or pulsed–dose–rate remote afterloader unit on a given day;

2. Before each patient treatment with a low–dose–rate remote afterloader unit; and

3. After each source installation.

(2) A licensee shall perform the measurements required by 41.2(59)“b”(1) in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot–check measurements.

(3) A licensee shall have the authorized medical physicist review the results of each spot check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot check.

(4) To satisfy the requirements of 41.2(59)“b”(1), spot checks must, at a minimum, ensure proper operation of:

1. Electrical interlocks at each remote afterloader unit room entrance;

2. Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

3. Viewing and intercom systems in each high–dose–rate, medium–dose–rate, and pulsed–dose–rate remote afterloader facility;

4. Emergency response equipment;

5. Radiation monitors used to indicate the source position;

6. Timer accuracy;

7. Clock (date and time) in the unit’s computer; and

8. Decayed source(s) activity in the unit’s computer.

(5) If the results of the spot checks required in 41.2(59)“b”(4) indicate the malfunction of any system, the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(6) A licensee shall retain a record of each spot check required in 41.2(59)“b”(4) and a copy of the procedures required by 41.2(59)“b”(2). The record must include:

1. The date of the spot check;

2. The manufacturer’s name, model number, and serial number for the remote afterloader unit and source;

3. An assessment of timer accuracy;

4. Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit’s computer; and

5. The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check.

(7) A licensee shall retain a copy of the procedures required in 41.2(59)“b”(2) until the licensee no longer possesses the remote afterloader unit.

c. Gamma stereotactic radiosurgery units.

(1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot checks for the gamma stereotactic radiosurgery facility and on each unit:

1. Monthly;

2. Before the first use of the unit on a given day; and

3. After each source installation.

(2) A licensee shall:

1. Perform the measurements required by 41.2(59)“c”(1) in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot–check measurements.

2. Have the authorized medical physicist review the results of each spot check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot check.

(3) To satisfy the requirements of 41.2(59)“c”(1)“1,” spot checks must, at a minimum:

1. Ensure proper operation of treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off; helmet microswitches; emergency timing circuits; and stereotactic frames and localizing devices (trunnions).

2. Determine:

• The output for one typical set of operating conditions measured with the dosimetry system described in 41.2(57);

• The difference between the measurement made in the above bulleted point and the anticipated output expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);

• Source output against computer calculation;

• Timer accuracy and linearity over the range of use;

• On–off error; and

• Trunnion centricity.

(4) To satisfy the requirements of 41.2(59)“c”(1)“2” and “3,” spot checks must ensure proper functioning of:

1. Electrical interlocks at each gamma stereotactic radiosurgery room entrance;

2. Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

3. Viewing and intercom systems;

4. Timer termination;

5. Radiation monitors used to indicate room exposures; and

6. Emergency off buttons.

(5) A licensee shall arrange as soon as possible for the repair of any system identified in 41.2(59)“c”(3) that is not operating properly.

(6) If the results of the spot checks required in 41.2(59)“c”(4) indicate the malfunction of any system, the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(7) A licensee shall retain a record of each spot check required by 41.2(59)“c”(3) and (4) and a copy of the procedures required in 41.2(59)“c”(2). The record must include:

1. The date of the spot check;

2. The manufacturer’s name, model number, and serial number for the gamma stereotactic radiosurgery unit and the survey instrument used to measure the output of the unit;

3. An assessment of timer linearity and accuracy;

4. The calculated on–off error;

5. A determination of trunnion centricity;

6. The difference between the anticipated output and the measured output;

7. As assessment of source output against computer calculations;

8. Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, on–off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and

9. The name of the individual who performed the periodic spot check and the signature of the authorized medical physicist who reviewed the record of the spot check.

(8) A licensee shall retain a copy of the procedures required in 41.2(59)“c”(2) until the licensee no longer possesses the gamma stereotactic radiosurgery unit.

ITEM 54. Rescind subrule 41.2(60), paragraphs “a” and “b,” and adopt in lieu thereof new paragraphs “a” and “b” as follows:

a. In addition to the survey requirements in 641- 40.36(136C), a person licensed under 641-41.2(136C) shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source with the source in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry.

b. The licensee shall make the survey required in 41.2(60)“a” at installation of a new source, and following repairs to the source shielding, the source driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source, or compromise the radiation safety of the source.

ITEM 55. Amend subrule 41.2(64), paragraphs “a” and “c,” as follows:

a. A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during teletherapy source replacement or at intervals not to exceed five years, whichever comes first, to ensure proper functioning of the source exposure mechanism.

c. A licensee shall maintain a record of the inspection and servicing for the duration of the license. The record shall contain the inspector’s name, the inspector’s license number, the date of inspection, the manufacturer’s name and model number and serial number for both the teletherapy unit and gamma stereotactic radiosurgery unit and source, a list of components inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of the inspector.

ITEM 56. Rescind subrule 41.2(65) and adopt the following new subrule in lieu thereof:

41.2(65) Training for radiation safety officer. Except as provided in 41.2(66), an individual fulfilling the responsibilities of the radiation safety officer as provided in 41.2(8) shall be an individual who:

a. Is certified by a specialty board whose certification process includes all of the requirements in 41.2(65)“b” and whose certification has been recognized by this agency, the NRC, or an agreement state; or

b. Has completed a structured educational program consisting of:

(1) 200 hours of didactic training in:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity;

4. Radiation biology; and

5. Radiation dosimetry; and

(2) One year of full–time radiation safety experience under the supervision of the individual identified as the radiation safety officer on an NRC or agreement state license or permit issued by an NRC master material license that authorizes similar types of use of by–product material involving the following:

1. Shipping, receiving, and performing related radiation surveys;

2. Using and performing checks for proper operation of instruments used to determine the activity of dosages and meters, and instruments used to measure radionuclides;

3. Securing and controlling radioactive material;

4. Using administrative controls to avoid mistakes in the administration of radioactive material;

5. Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;

6. Using emergency procedures to control radioactive material; and

7. Disposing of radioactive material; and

(3) Has obtained written certification, signed by a preceptor radiation safety officer, that the individual has satisfactorily completed the requirements of 41.2(65)“b” and has achieved a level of radiation safety knowledge sufficient to function independently as a radiation safety officer for a medical use licensee; or

c. Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the license and has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual has radiation safety officer responsibilities.

ITEM 57. Amend subrule 41.2(66) as follows:

41.2(66) Training for experienced radiation safety officer. An individual identified as a radiation safety officer on an agency, agreement state, licensing state, or U.S. Nuclear Regulatory Commission NRC license on September 1, 1992 January 1, 2003, who oversees only the use of radioactive material for which the licensee was authorized on that date need not comply with the training requirements of 41.2(65).

ITEM 58. Rescind subrule 41.2(67) and adopt the following new subrule in lieu thereof:

41.2(67) Training for uptake, dilution, and excretion studies. Except as provided in 41.2(76), the licensee shall require an authorized user of unsealed by–product material for uses authorized under 41.2(31) to be a physician who:

a. Is certified by a medical specialty board whose certification process includes all of the requirements in 41.2(67)“b” and whose certification has been recognized by the NRC or an agreement state; or

b. Is an authorized user under 41.2(68) or 41.2(69) or equivalent NRC or agreement state requirements; or

c. Has completed 60 hours of training and experience in basic radionuclide handling techniques applicable to medical use of unsealed by–product material for uptake, dilution, and excretion studies. The training and experience shall include:

(1) Classroom and laboratory training in the following areas:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity;

4. Chemistry of by–product material for medical use; and

5. Radiation biology; and

(2) Work experience, under the supervision of an authorized user who meets the requirements in 41.2(67) or 41.2(69) or equivalent NRC or agreement state requirements involving:

1. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

2. Calibrating instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

3. Calculating, measuring, and safely preparing patient or human research subject dosages;

4. Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

5. Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

6. Administering dosages of radioactive drugs to patients or human research subjects; and

(3) Written certification, signed by a preceptor authorized user who meets the requirements in 41.2(68) or 41.2(69), that the individual has satisfactorily completed requirements of 41.2(67)“b” and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 41.2(31).

ITEM 59. Rescind subrule 41.2(68) and adopt the following new subrule in lieu thereof:

41.2(68) Training for imaging and localization studies. Except as provided in 41.2(76), the licensee shall require an authorized user of unsealed by–product material for medical uses as authorized under 41.2(33) to be a physician who:

a. Is certified by a medical specialty board whose certification includes all of the requirements in 41.2(68)“b” and whose certification has been recognized by this agency, the NRC or an agreement state; or

b. Has completed 700 hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed by–product material for imaging and localization studies. The training and experience must include, at a minimum:

(1) Classroom and laboratory training in the following areas:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity;

4. Chemistry of by–product material for medical use; and

5. Radiation biology; and

(2) Work experience, under the supervision of an authorized user, who meets the requirements in 41.2(68) or 41.2(69) or equivalent NRC or agreement state requirements, involving:

1. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

2. Calibrating instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

3. Calculating, measuring, and safely preparing patient or human research subject dosages;

4. Using administrative controls to prevent a medical event involving the use of unsealed by–product material;

5. Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;

6. Administering dosages of radioactive drugs to patients or human research subjects; and

7. Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclide purity, and processing the eluate with reagent kits to prepare radioactive drugs; and

(3) Written certification, signed by a preceptor authorized user who meets the requirements in 41.2(68) or 41.2(69), that the individual has satisfactorily completed the requirements in 41.2(68) and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized in 41.2(31) and 41.2(33).

ITEM 60. Rescind subrule 41.2(69) and adopt the following new subrule in lieu thereof:

41.2(69) Training for therapeutic use of radiopharmaceuticals or use of unsealed by–product material for which a written directive is required.

a. Except as provided in 41.2(66), 41.2(75), and 41.2(79), the licensee shall require the authorized user of unsealed by–product material authorized in 41.2(37) to be a physician who:

(1) Is certified by a medical specialty board whose cer–tification process includes all of the requirements in 41.2(69)“a”(2) and whose certification has been recognized by the NRC or an agreement state; or

(2) Has completed 700 hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed by–product material requiring a written directive. The training and experience must include:

1. Classroom and laboratory training in the following areas: radiation physics and instrumentation; radiation protection; mathematics pertaining to the use and measurement of radioactivity; chemistry of by–product material for medical use; and radiation biology; and

2. Work experience, under the supervision of an authorized user who meets the requirements of 41.2(69)“a”(1) or (2). A supervising authorized user who meets the requirements of 41.2(69)“a”(2) must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status. The work experience must involve:

• Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

• Calibrating instruments used to determine the activity of dosages and performing checks for proper operation of meters;

• Calculating, measuring, and safely preparing patient or human research subject dosages;

• Using administrative controls to prevent a medical event involving the use of unsealed by–product material;

• Using procedures to contain spilled by–product material safely and using proper decontamination procedures;

• Eluting generator systems, measuring and testing the eluate for radionuclide purity, and processing the eluate with reagent kits to prepare radioactive drugs; and

• Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of three cases in each of the following categories for which the individual is requesting authorized user status:

(a) Oral administration of less than or equal to 33 millicuries (1.22 GBq) of sodium iodide I–131;

(b) Oral administration of greater than 33 millicuries (1.22 GBq) of sodium iodide I–131. Experience with at least three cases in this category also satisfies the requirements in (a) above;

(c) Parenteral administration of any beta emitter or aphoton–emitting radionuclide with a photon energy less than 150 keV; or

(d) Parenteral administration of any other radionuclide; and

3. Has obtained written certification that the individual has satisfactorily completed the requirements in 41.2(69)“a”(2)“1” and has achieved a level of competency sufficient to function independently as an authorized user in the medical uses authorized in 41.2(37). The written certification must be signed by a preceptor authorized user meeting the requirements in 41.2(69)“a”(1) or (2), or equivalent NRC or agreement state requirements. The preceptor authorized user who meets the requirements in 41.2(69)“a”(2) must have experience in administering dosages in the same dosage or categories (i.e., 41.2(69)“a”(2)“2,” last bulleted paragraph) as the individual requesting authorized user status.

b. Training for the oral administration of sodium iodide I–131 requiring a written directive in quantities less than or equal to 33 millicuries (1.22 GBq). Except as provided in 41.2(66), 41.2(75), and 41.2(79), the licensee shall requirean authorized user for the oral administration of sodiumiodide–131 requiring a written directive in quantities less than or equal to 33 millicuries (1.22 GBq) to be a physician who:

(1) Is certified by a medical specialty board whose certification process includes all of the requirements in 41.2(69)“b”(3) and whose certification has been recognized by this agency, the NRC, or an agreement state; or

(2) Is an authorized user under 41.2(69)“a”(1) or (2) for uses listed in 41.2(69)“a”(2)“2,” last bulleted paragraph, (a) or (b), or equivalent NRC or agreement state requirements; or

(3) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I–131 for procedures requiring a written directive. The training must include:

1. Radiation physics and instrumentation; radiation protection; mathematics pertaining to the use and measurement of radioactivity; chemistry of by–product material for medical use; and radiation biology; and

2. Work experience, under the supervision of an authorized user who meets the requirement in 41.2(69)“a”(1) or (2) or 41.2(69)“b,” or equivalent NRC or agreement state requirements. A supervising authorized user who meets the requirements in 41.2(69)“a”(2) must have experience in administering dosages as specified in 41.2(69)“a”(2)“2,” last bulleted paragraph. The work experience must involve:

• Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

• Calibrating instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

• Calculating, measuring, and safely preparing patient or human research subject dosages;

• Using administrative controls to prevent a medical event involving the use of by–product material;

• Using procedures to contain spilled by–product material safely and using proper decontamination procedures;

• Administering dosages to patients or human research subjects that includes at least three cases involving the administration of less than or equal to 33 millicuries (1.22 GBq); and

3. Written certification that the individual has satisfactorily completed the requirements in 41.2(69)“b”(3)“2” and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under 41.2(37). The written certification must be signed by a preceptor authorized user who meets the requirements of 41.2(69), or NRC or equivalent agreement state requirements. A preceptor authorized user who meets the requirements of 41.2(69)“a”(2) must have experience in administering dosages specified in 41.2(69)“a”(2)“2,” last bulleted paragraph, (a) and (b).

ITEM 61. Rescind subrule 41.2(70) and adopt the following new subrule in lieu thereof:

41.2(70) Training for therapeutic use of manual brachytherapy sources. Except as provided in 41.2(66), 41.2(75), and 41.2(79), the licensee shall require the authorized user using a manual brachytherapy source authorized in 41.2(43) to be a physician who:

a. Is certified by a medical specialty board whose certification process includes all of the requirements in 41.2(70)“b” and whose certification has been recognized by this agency, the NRC, or an agreement state; or

b. Has completed a structured educational program in basic radionuclide handling techniques applicable to the manual brachytherapy sources that includes:

(1) 200 hours of classroom and laboratory training in the following areas:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity; and

4. Radiation biology; and

(2) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in 41.2(70)“b” or equivalent NRC or agreement state requirements at a medical institution, involving:

1. Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

2. Checking survey meters for proper operation;

3. Preparing, implanting, and removing brachytherapy sources;

4. Maintaining running inventories of material on hand;

5. Using administrative controls to prevent a medical event involving the use of by–product material; and

6. Using emergency procedures to control by–product material; and

(3) Has obtained three years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in 41.2(70) or equivalent NRC or agreement state requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by 41.2(70)“b”(2); and

(4) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in 41.2(70) or NRC or equivalent agreement state requirements, that the individual has satisfactorily completed the requirements in 41.2(70)“b” and has achieved a level of competency sufficient to function independently as an authorized user of manual brachytherapy sources for the medical uses authorized in 41.2(43).

ITEM 62. Rescind subrule 41.2(71) and adopt the following new subrule in lieu thereof:

41.2(71) Training for ophthalmic use of strontium–90. Except as provided in 41.2(66), 41.2(75), and 41.2(79), the licensee shall require the authorized user of strontium–90 for ophthalmic radiotherapy be a physician who:

a. Is an authorized user under 41.2(70) or equivalent NRC or agreement state requirements; or

b. Has completed 24 hours of classroom and laboratory training applicable to the medical use of strontium ophthalmic radiotherapy.

(1) The training must include:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity; and

4. Radiation biology; and

(2) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium–90 for the ophthalmic treatment of five individuals. The supervised training must involve:

1. Examination of each individual to be treated;

2. Calculation of the dose to be administered;

3. Administration of the dose; and

4. Follow–up and review of each individual’s case history; and

(3) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in 41.2(71), that the individual has satisfactorily completed the requirements of 41.2(71)“a” and “b” and has achieved a level of competency sufficient to function independently as an authorized user of strontium–90 for ophthalmic use.

ITEM 63. Rescind subrule 41.2(72) and adopt the following new subrule in lieu thereof:

41.2(72) Training for use of sealed sources for diagnosis. Except as provided in 41.2(66), 41.2(75), and 41.2(79), the licensee shall require the authorized user of a diagnostic sealed source for use in a device authorized in 41.2(41) to be a physician, dentist, or podiatrist who:

a. Is certified by a specialty board whose certification process includes all of the requirements in 41.2(72)“b” and whose certification has been recognized by this agency, the NRC, or an agreement state; or

b. Has had eight hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity;

(4) Radiation biology; and

(5) Training in the use of the device for the uses requested.

ITEM 64. Rescind subrule 41.2(73) and adopt the following new subrule in lieu thereof:

41.2(73) Training for remote afterloader units, teletherapy, and gamma stereotactic radiosurgery units. Except as provided in 41.2(66), 41.2(75), and 41.2(77), the licensee shall require the authorized user of a sealed source specified in 41.2(49) to be a physician who:

a. Is certified by a medical specialty board whose certification process includes all of the requirements in 41.2(73)“b” and whose certification has been recognized by this agency, the NRC, or an agreement state; or

b. Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:

(1) 200 hours of classroom and laboratory training in the following areas:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity; and

4. Radiation biology; and

(2) 500 hours of work experience, under the supervision of an authorized user who meets the requirements of 41.2(73)“b” or NRC or equivalent agreement state requirements at a medical institution, involving:

1. Review of the full calibration measurements and periodic spot checks;

2. Preparing treatment plans and calculating treatment doses and times;

3. Using administrative controls to prevent a medical event involving the use of by–product material;

4. Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;

5. Checking and using survey meters; and

6. Selecting the proper dose and how it is to be administered; and

(3) Has completed three years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements of 41.2(73) or NRC or equivalent agreement state requirements, as part of a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by 41.2(73)“b”(2); and

(4) Has obtained written certification that the individual has satisfactorily completed the requirements of 41.2(73)“b” and has achieved a level of competency sufficient to function independently as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The written certification must be signed by a preceptor authorized user who meets the requirements of 41.2(73) for each type of therapeutic medical unit for which the individual is requesting authorized user status.

ITEM 65. Rescind subrule 41.2(74) and adopt the following new subrule in lieu thereof:

41.2(74) Training for teletherapy physicist or authorized medical physicist. Except as provided in 41.2(66), 41.2(75), and 41.2(77), the licensee shall require the authorized medical physicist to be an individual who:

a. Is certified by a specialty board whose certification process includes all of the training and experience required in 41.2(74)“b” and whose certification has been recognized by this agency, the NRC, or an agreement state for by–product use only; or

b. Holds a master’s or doctor’s degree in physics, biophysics, radiological physics, medical physics, or health physics; and

(1) Has completed one year of full–time training in therapeutic radiological physics and an additional year of full–time work experience, under the supervision of an individual who meets the requirements of a teletherapy physicist or authorized medical physicist at a medical institution, that includes the tasks listed in 41.2(21), 41.2(58), 41.2(59), 41.2(60), and 41.2(85), as applicable; and

(2) Has obtained written certification that the indi–vidual has satisfactorily completed the requirements of 41.2(74)“b”(1) and has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written certification must be signed by a preceptor authorized medical physicist who meets the requirements of 41.2(74) for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.

ITEM 66. Adopt the following new subrule:

41.2(75) Training for experienced authorized users and teletherapy or medical physicists.

a. An individual identified as a teletherapy or medical physicist on an NRC or agreement state license or a permit issued by an NRC or agreement state broad scope licensee or master material license permit or by a master material license permittee of broad scope before January 1, 2003, does not need to comply with the training requirements of 41.2(73).

b. Physicians, dentists, or podiatrists identified as authorized users for the medical use of by–product material issued by this agency, the NRC, or agreement state, a permit issued by an NRC master material licensee, a permit issued by an NRC broad scope permittee before January 1, 2003, who perform only those medical uses for which they were authorized before that date need not comply with the training requirements of 41.2(68), 41.2(69), 41.2(70), 41.2(71), 41.2(72), or 41.2(73).

ITEM 67. Amend subrule 41.2(77) as follows:

41.2(77) Recentness of training. The training and experience specified in 41.2(65) to 41.2(79) and 41.2(81) shall have been obtained within the seven years preceding the date of application or the individual shall have had related continuing education and continuing applicable experience since the required training and experience were completed.

ITEM 68. Rescind subrule 41.2(78) and adopt the following new subrule in lieu thereof:

41.2(78) Training for an authorized nuclear pharmacist. Except as provided in 41.2(79), the licensee shall require the authorized nuclear pharmacist to be a pharmacist who:

a. Is certified as a nuclear pharmacist by a specialty board whose certification process includes all of the requirements of 41.2(78)“b” and whose certification has been recognized by the NRC or agreement state; or

b. Has completed 700 hours in a structured education program consisting of both:

(1) Didactic training in the following areas:

1. Radiation physics and instrumentation;

2. Radiation protection;

3. Mathematics pertaining to the use and measurement of radioactivity;

4. Chemistry of by–product material for medical use; and

5. Radiation biology; and

(2) Supervised practical experience in a nuclear pharmacy involving:

1. Shipping, receiving, and performing related radiation surveys;

2. Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters and, if appropriate, instruments used to measurealpha– or beta–emitting radionuclides;

3. Calculating, assaying, and safely preparing dosages for patients or human research subjects;

4. Using administrative controls to avoid medical events in the administration of by–product material; and

5. Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and

c. Has obtained written certification, signed by a preceptor authorized nuclear pharmacist, that the individual satisfactorily completed the requirements in 41.2(78)“b” and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.

ITEM 69. Rescind subrule 41.2(79) and adopt the following new subrule in lieu thereof:

41.2(79) Training for experienced nuclear pharmacists. An individual identified as a nuclear pharmacist on an NRC or agreement state license or permit issued by an NRC or agreement state broad scope licensee or master material license permit or by a master material license permittee of broad scope before January 1, 2003, need not comply with the training requirements of 41.2(78).

ITEM 70. Adopt new subrules 41.2(83) to 41.2(87) as follows:

41.2(83) Provisions for the protection of human research subjects.

a. A licensee may conduct research involving human research subjects only if the licensee uses the radioactive materials authorized on its specific license for the uses authorized on its license.

b. If the research is conducted, funded, supported, or regulated by another federal agency that has implemented Federal Policy for the Protection of Human Subject (Federal Policy), the licensee shall, before conducting research:

(1) Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy; and

(2) Obtain “informed consent,” as defined and described in the Federal Policy, from the human research subject.

c. If the research will not be conducted, funded, supported, or regulated by another federal agency that has the Federal Policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its medical use license. The amendment request must include a written commitment that the licensee will, before research:

(1) Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy; and

(2) Obtain “informed consent,” as defined and described in the Federal Policy, from the human research subject.

d. Nothing in this subrule relieves a licensee from complying with the other requirements of these rules.

41.2(84) Calibration measurements of brachytherapy sources.

a. Before the first medical use of a brachytherapy source on or after January 1, 2003, a licensee shall have:

(1) Determined the source output or activity using a dosimetry system that meets the requirements of 41.2(57);

(2) Determined the source positioning accuracy within applicators; and

(3) Used published protocols currently accepted by nationally recognized bodies to meet the requirements of 41.2(84)“a.”

b. A licensee may use measurements that are provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine and that are made in accordance with 41.2(84)“a”(1) and (2).

c. A licensee shall mathematically correct the outputs or activities determined in 41.2(84)“a” for physical decay at intervals consistent with 1 percent physical decay.

d. A licensee shall retain a record of each calibration for three years after the last use of the source. The record must include:

(1) The date of the calibration;

(2) The manufacturer’s name, model number, and serial number for the source and the instruments used to calibrate the source;

(3) The source output or activity;

(4) The source positioning accuracy within the applicators; and

(5) The signature of the authorized medical physicist.

41.2(85) Decay of strontium–90 sources for ophthalmic treatment.

a. Only an authorized medical physicist shall calculate the activity of each strontium–90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under 41.2(85).

b. A licensee shall retain a record of the activity of each strontium–90 source in accordance with 41.2(84).

41.2(86) Therapy–related computer systems. The licensee shall perform acceptance testing on the treatment planning system of therapy–related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance must include, as applicable, verification of:

a. The source–specific input parameters required by the dose calculation algorithm;

b. The accuracy of dose, dwell time, and treatment time calculations at representative points;

c. The accuracy of isodose plots and graphic displays;

d. The accuracy of the software used to determine sealed source positions from radiographic images; and

e. The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

41.2(87) Written directives. Each licensee or registrant shall meet the following objectives:

a. Prior to administration, a written directive must contain the patient’s or human research subject’s name and the following information:

(1) For any administration of quantities greater than 30 microcuries of either sodium iodide I–125 or I–131: the dosage;

(2) For a therapeutic administration of a radiopharmaceutical other than sodium iodide I–125 or I–131: the radiopharmaceutical, dosage, and route of administration;

(3) For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose;

(4) For teletherapy, particle accelerator or X–ray: the total dose, dose per fraction, number of fractions, treatment site, and overall treatment period;

(5) For high–dose–rate remote afterloading brachytherapy: the radioisotope, treatment site, and total dose; or

(6) For all other brachytherapy, including low–, medium–, and pulsed–dose–rate remote afterloaders:

1. Prior to implantation: treatment site, the radioisotope, number of sources, and source strengths; and

2. After implantation but prior to completion of the procedure: the radioisotope, treatment site, number of sources, and total source strength and exposure time (or, equivalently, the total dose);

b. Prior to each administration, the patient’s or human research subject’s identity is verified by more than one method as the individual named in the written directive;

c. The final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives;

d. Each administration is in accordance with the written directive through checking both manual and computer–generated dose calculations and through verifying that any computer–generated dose calculations are correctly transferred into the consoles of the medical units authorized by 641—Chapter 41;

e. Any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken;

f. If, because of the emergent nature of the patient’s or human research subject’s condition, a delay in order to provide a written directive jeopardizes the patient’s or human research subject’s health, an oral directive is acceptable. The information contained in the oral directive must be documented as soon as possible in writing in the patient’s or human research subject’s record. A written directive must be prepared within 48 hours of the oral directive; and

g. A copy of the written directive in auditable form shall be retained for three years after the date of administration.

ITEM 71. Amend subrule 41.3(6) by rescinding paragraph “e.”

ITEM 72. Amend subrule 45.1(1) as follows:

45.1(1) Purpose and scope.

a. The rules in this chapter establish radiation safety requirements for using sources of radiation for industrial radiography. The requirements of this chapter are in addition to, and not in substitution for, other applicable requirements of 641-Chapters 38, 39, and 40. The rules in this chapter apply to all licensees or registrants who use sources of radiation for industrial radiography.

b. All references to any Code of Federal Regulations (CFR) in this chapter are those in effect as of July 1, 2002 January 1, 2003.

ITEM 73. Amend subrule 45.1(12), paragraph “b,” subparagraphs (1), (2), (4), and (8), as follows:

(1) No licensee or registrant shall permit an individual to act as a radiographer, radiographer trainee, or radiographer trainer unless at all times during radiographic operations each individual wears, on the trunk of the body, a combination of direct–reading pocket dosimeter, an operating alarm ratemeter, and a film badge, an optically luminescent stimulated device (OSL device) or a thermoluminescent dosimeter (TLD) that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP). For permanent radiographic installations where other appropriate alarming or warning devices are in routine use, the wearing of an alarm ratemeter is not required.

(2) Pocket dosimeters or electronic personal dosimeters shall meet the criteria in ANSI N322–1977 and shall have a range of zero to at least 200 milliroentgens millirems. Electronic personal dosimeters may only be used in place of ion–chamber pocket dosimeters.

(4) Pocket dosimeters or electronic personal dosimeters shall be read and exposures recorded at least once daily, the beginning and at the end of each work shift, and before each recharging.

(8) If an individual monitoring device is lost or damaged, the worker shall cease work immediately until a replacement individual monitoring device is provided and the exposure is calculated for the time period from issuance to loss or damage of the individual monitoring device. The results of the calculated exposure and the time period for which the individual monitoring device was lost or damaged must be included in the records maintained in 45.1(12)“c.”

ITEM 74. Amend subrule 45.1(12), paragraph “c,” as follows:

c. Records of pocket dosimeter readings of personnel exposures and yearly operability checks required in 45.1(12)“d” shall be maintained for two years by the licensee or registrant for agency inspection. If the dosimeter readings were used to determine external radiation dose (i.e., no TLD or film badge exposure records exist), the records shall be maintained until the agency authorizes disposal. Records of estimates of exposures as a result of off–scale personal direct reading dosimeters, or lost or damaged film badges, OSLs, or TLDs, shall be maintained until the agency terminates the license.

ITEM 75. Amend rule 641-45.6(136C), catchwords, as follows:

ITEM 76. Amend subrule 45.6(3) as follows:

Rescind the definition of “mineral–logging.”

Amend the following definitions:

“Logging supervisor” means the individual who uses sources of radiation licensed material or provides direct supervision of the utilization of sources of radiation at the well site. in the use of licensed material at a temporary job site and who is responsible to the licensee for ensuring compliance with the requirements of these rules and the conditions of the license.

“Radioactive marker” means radioactive licensed material placed subsurface or on a structure intended for subsurface use for the purpose of used for depth determination or direction orientation. For purposes of this rule, this term includes radioactive collar markers and radioactive iron nails.

“Source holder” means a housing or assembly into which a radioactive source sealed source is placed for the purpose of facilitating to facilitate the handling and use of the source in well–logging operations.

“Subsurface tracer study” means the release of unsealed licensed material or a substance tagged with radioactive labeled with licensed material in a single well for the purpose of tracing the movement or position of the tagged material or substance in the well–bore or adjacent formation.

“Temporary job site” means a location place where radioactive licensed materials are present for the purpose of performing wireline service operations well–logging or subsurface tracer studies.

“Well–bore” means a drilled hole in which wireline service operations or subsurface tracer studies are well–logging may be performed. As used in this rule, “well” includes drilled holes for the purpose of oil, gas, mineral, groundwater, or geological exploration.

“Well–logging” means all operations involving the lowering and raising of measuring devices or tools which may contain sources of radiation into well–bores or cavities licensed material or are used to detect licensed materials in wells for the purpose of obtaining information about the well or adjacent formations and which may be used in oil, gas, mineral, groundwater, or geological exploration.

Adopt the following new definitions:

“Energy compensation source (ECS)” means a small sealed source, with an activity not exceeding 3.7 MBq (100 microcuries), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool’s calibration when in use.

“Fresh water aquifer” means a geologic formation that is capable of yielding fresh water to a well or spring.

“Personal supervision” means guidance and instruction by the logging supervisor who is physically present at the temporary job site, who is in personal contact with logging assistants, and who can give immediate assistance.

“Safety review” means a periodic review on radiation safety aspects of well–logging provided by the licensee for its employees. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, accidents or errors that have been observed, and opportunities for employees to ask safety questions.

“Surface casing” for protecting fresh water aquifers means a pipe or tube used as a lining in a well to isolate fresh water aquifers from the well.

“Tritium neutron generator target source” means a tritium source used within a neutron generator tube to produce neutrons for use in well–logging applications.

ITEM 77. Rescind subrule 45.6(4) and adopt the following new subrule in lieu thereof:

45.6(4) Agreement with well owner or operator.

a. A licensee may perform well–logging with a sealed source only after the licensee has a written agreement with the employing well owner or operator. This written agreement must identify who will meet the following requirements:

(1) If a sealed source becomes lodged in the well, a reasonable effort will be made to recover it;

(2) A person may not attempt to recover a sealed source in a manner which, in the licensee’s opinion, could result in its rupture;

(3) The radiation monitoring required in 45.6(8) and 45.6(17) will be performed;

(4) If the environment, any equipment, or personnel are contaminated with licensed material, they must be decontaminated before release from the site or release for unrestricted use; and

(5) If the sealed source is classified as irretrievable after reasonable efforts at recovery have been expended, the following requirements must be implemented within 30 days:

1. Each irretrievable well–logging source must be immobilized and sealed in place with a cement plug;

2. There must be a means to prevent inadvertent intrusion on the source, unless the source is not accessible to any subsequent drilling operations; and

3. A permanent identification plaque, constructed of long–lasting material, such as stainless steel, brass, bronze, or Monel, must be mounted at the surface of the well, unless the mounting of the plaque is not practical. The size of the plaque must be at least 17 cm (7 inches) square and 3 mm (1/8–inch) thick. The plaque must contain:

• The word “Caution”;

• The radiation symbol (the color requirement in 641- 40.60(136C) need not be met);

• The date the source was abandoned;

• The name of the well owner or well operator, as appropriate;

• The well name and well identification number(s) or other designation;

• An identification of the sealed source(s) by radionuclide and quantity;

• The depth of the source and depth to the top of the plug; and

• An appropriate warning such as, “Do not reenter this well.”

b. The licensee shall retain a copy of the written agreement for three years after the completion of the well–logging operation.

c. A licensee may apply, pursuant to 641-38.3(136C), for agency approval, on a case–by–case basis, of proposed procedures to abandon an irretrievable well–logging source in a manner not otherwise authorized in 45.6(26)“a”(5).

d. A written agreement between the licensee and the well owner or operator is not required if the licensee and the well owner or operator are part of the same corporate structure or otherwise similarly affiliated. However, the licensee shall still otherwise meet the requirements in 45.6(26)“a”(1) through (5).

ITEM 78. Amend subrule 45.6(9) as follows:

45.6(9) Leak testing of sealed sources.

a. Requirements Testing and record–keeping requirements. Each licensee using sealed sources of radioactive material shall have the sources tested for leakage periodically. Records of leak test results shall be kept in units of microcuries (Bq) and maintained for inspection by the agency for six months after the next required leak test is performed or until transfer or disposal of the sealed source for three years after the leak test is performed.

b. Method of testing. Tests for leakage shall be performed only by persons specifically authorized to perform such tests by the agency, the U.S. Nuclear Regulatory Commission the NRC, an agreement state, or a licensing state. The wipe of a sealed source must be performed using a leak test kit or method approved by the NRC, an agreement state, or a licensing state. The test sample shall be taken from the surface of the source, source holder, or from the surface of the device in which the source is stored or mounted and on which one might expect contamination to accumulate. The wipe sample must be taken from the nearest assessable point to the sealed source where contamination might accumulate. The test sample shall be analyzed for radioactive contamination, and the analysis shall be capable of detecting the presence of 0.005 microcurie (185 Bq) of radioactive material on the test sample.

c. Interval of testing.

(1) Each sealed source of radioactive material (except an energy compensation source (ECS)) shall be tested at intervals not to exceed six months. In the absence of a certificate from a transferor indicating that a test has been made six months prior to the transfer, the sealed source shall not be put into use until tested. If, for any reason, it is suspected that a sealed source may be leaking, it shall be removed from service immediately and tested for leakage as soon as practical.

d. Leaking or contaminated sources.

(1) If the test in 45.6(9)“c” reveals the presence of 0.005 microcurie (185 Bq) or more of leakage or contamination removable radioactive material, the licensee shall immediately withdraw the source from use and shall cause it to be decontaminated, repaired, or disposed of in accordance with these rules by an NRC, agreement state, or licensing state licensee that is authorized to perform these functions. The licensee shall check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of by an NRC, agreement state, or licensing state licensee that is authorized to perform these functions.

(2) A report describing the equipment involved, the test results, any contamination which resulted from the leaking source, and the corrective action taken up to the time of the report shall be filed with the agency within five days of receiving the test results.

e. Exemptions. The following sources are exempted from the periodic leak test requirements of 45.6(9)“a” to “d”:

(1) Hydrogen–3 (tritium) sources;

(2) Sources of radioactive material with a half–life of 30 days or less;

(3) Sealed sources of radioactive material in gaseous form;

(4) Sources of beta– or gamma–emitting radioactive material with an activity of 100 microcuries (3.7 MBq) or less; and

(5) Sources of alpha–emitting radioactive material with an activity of 10 microcuries (0.370 MBq) or less.

ITEM 79. Amend subrule 45.6(12) as follows:

45.6(12) Design, performance, and certification criteria for sealed sources used in downhole well–logging operations.

a. Each sealed source, except those containing radioactive material in gaseous form, used in downhole operations shall be certified by the manufacturer, or other testing organization acceptable to the agency, to meet the following minimum criteria: A licensee may use a sealed source for use in well–logging applications if:

(1) Be of The sealed source is doubly encapsulated construction;

(2) Contain radioactive material whose The sealed source contains chemical and physical forms that are as insoluble and nondispersible as practical; and

(3) Has been individually pressure tested to at least 24,656 pounds per square inch absolute (170 MN/m²) without failure. The sealed source meets the requirements of 45.6(12)“b,” “c,” and “d.”

c b. Each sealed source, except those containing radioactive material in gaseous form, used in downhole operations, shall be certified by the manufacturer, or other testing organization acceptable to the agency, as meeting the sealed source performance requirements for oil well–logging as contained in the American National Standard Institute (ANSI) N542–1977 or United States of America Standards Institute (USASI) N5.10–1968. For a sealed source man– ufactured on or before July 14, 1989, a licensee may use the sealed source for use in well–logging applications if it meets the requirements of USASI N5.10–1968, “Classificationof Sealed Radioactive Sources,” or the requirements in 45.6(12)“c” or “d.”

d. Certification documents shall be maintained for inspection by the agency for a period of two years after source disposal. If the source is abandoned downhole, the certification documents shall be maintained until the agency authorizes disposition. For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source for use in well–logging applications if the sealed source’s prototype has been tested and found to maintain its integrity after each of the following tests:

ITEM 80. Amend subrule 45.6(17), paragraphs “a” and “b,” as follows:

a. No licensee or registrant shall permit any individual to act as a logging supervisor or to assist in the handling of sources of radiation unless each such individual wears, at all times during the handling of licensed radioactive materials, a film badge, OSL device or thermoluminescent dosimeter (TLD) that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP). Each film badge, OSL device or TLD shall be assigned to and worn by only one individual. Film badges must be replaced at least monthly and OSL devices and TLDs replaced at least quarterly. After replacement, each film badge, OSL device or TLD must be promptly processed.

b. Personnel monitoring records and bioassay results shall be maintained for inspection until the agency authorizes disposition.

ITEM 81. Amend subrule 45.6(25), paragraph “c,” subparagraph (2), as follows:

(2) Notify the agency by telephone, giving the circumstances of the loss, and request approval of the proposed abandonment procedures, or specify the implemented abandonment before receiving approval because the licensee believed there was an immediate threat to public health and safety; and

ITEM 82. Amend subrule 45.6(25), paragraph “c,” subparagraph (3), by adopting new numbered paragraph “9” and renumbering numbered paragraphs “9” and “10” as “10” and “11”as follows:

9 10. Any other information, such as a warning statement, contained on the permanent identification plaque; and

10 11. The names of state agencies receiving a copy of this report.

ITEM 83. Adopt new subrules 45.6(27) to 45.6(31) as follows:

45.6(27) Radioactive markers. The licensee may use radioactive markers in wells only if the individual markers contain quantities of licensed material not exceeding the quantities specified in 641—Chapter 39, Appendix B, Exempt Quantities. The use of markers is subject only to the requirements of 45.6(10).

45.6(28) Uranium sinker bars. The licensee may use uranium sinker bars in well–logging applications only if they are legibly impressed with the words “CAUTION—RADIOACTIVE–DEPLETED URANIUM” and “NOTIFY CIVIL AUTHORITIES [or Company name] IF FOUND.”

45.6(29) Use of a sealed source in a well without a surface casing. The licensee may use a sealed source in a well without a surface casing for protecting fresh water aquifers only if the licensee follows a procedure for reducing the probability of the source’s becoming lodged in the well. The procedure must be approved by the NRC or licensing or agreement state.

45.6(30) Energy compensation source. The licensee may use an energy compensation source (ECS) which is contained within a logging tool, or other tool components, only if the ECS contains quantities of licensed material not exceeding 100 microcuries (3.7 MBq).

a. For well–logging applications with a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of 45.6(9) to 45.6(11).

b. For well–logging applications without a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of 45.6(4), 45.6(9) to 45.6(11), 45.6(25), and 45.6(29).

45.6(31) Tritium neutron generator target source.

a. Use of a tritium neutron generator target source that contains quantities not exceeding 30 curies (1110 MBq) and that is in a well with a surface casing to protect fresh water aquifers is subject to the requirements of this rule except subrules 45.6(4), 45.6(12), and 45.6(25).

b. Use of a tritium neutron generator target source that contains quantities exceeding 30 curies (1110 MBq) or that is in a well without a surface casing to protect fresh water aquifers is subject to the requirements of this rule except subrule 45.6(12).

Pursuant to the authority of Iowa Code section 135.102, the Department of Public Health hereby gives Notice of Intended Action to rescind Chapter 72, “Childhood Lead Poisoning Prevention Program,” Iowa Administrative Code, and adopt a new Chapter 72 with the same title.

Iowa Code section 135.102 directs the Department to adopt rules regarding the implementation of the childhood lead poisoning prevention grant program and the standards and program requirements of the childhood lead poisoning prevention grant program pursuant to section 135.103. The Department adopted rules in 1987 and made minor revisions to the rules in 2001.

The proposed rules incorporate the concept of providing funding to “approved” programs as specified in Iowa Code section 135.103 by defining an approved program as a program that is immediately prepared to provide the services outlined in subrule 72.2(3) and by specifying the process by which a local board of health or a group of local boards of health can be granted status as an approved program. The proposed rules specify that an application for status as an approved program must represent a geographic area with a population of at least 15,000. This is necessary to achieve efficiency in data management and in the provision of elevated blood lead (EBL) inspections. The proposed rules also specify that state funds shall be provided to approved programs on the basis of a formula that predicts the burden of childhood lead poisoning in the geographic area of the approved program and that federal funds shall be provided to approved programs on the basis of the same formula unless a different method is mandated by the federal agency providing the funding. The proposed rules are consistent with Action Step 6–8.1 of “Healthy Iowans 2010,” which proposes that the Department initiate additional local childhood lead poisoning prevention programs and continue to support existing programs so that, by January 2005, these programs will be available in all 99 counties.

State funds appropriated for local childhood lead poisoning prevention programs are used to leverage $800,000 of federal funds from the Centers for Disease Control and Prevention (CDC). In the application to CDC for funds, the Department must provide the names of all local agencies that are proposed to receive state and federal funds and the detailed budget and work plan for each local agency. The Department must know by January 1 of each year the names of the local agencies that it proposes will receive funds in order to prepare the application for CDC funds and submit it by the usual deadline of March 15. In order to meet the requirements and timelines for the CDC funding that the Department is eligible to receive for the program year of July 1, 2003, through June 30, 2004, the proposed rules specify that the 73 counties receiving funding for the current program year of July 1, 2002, through June 30, 2003, will be considered approved programs that will receive funding for the program year of July 1, 2003, through June 30, 2004. The current contractors for each county will continue to receive funding for the program year of July 1, 2003, through June 30, 2004, unless the local board requests otherwise by March 1, 2003. For the program year of July 1, 2004, through June 30, 2005, each local board of health that wishes to receive funding must apply for status as an approved program by December 1, 2003. In future years, each local board of health that wishes to receive funding must apply for status as an approved program by December 1 to receive funding for the following program year. The Department will provide a minimal level of childhood lead poisoning prevention services in the counties that do not have status as approved programs. The Department will also provide technical assistance and training to all counties that wish to achieve status as approved programs.

Consideration will be given to all written suggestions or comments on the proposed rules received on or before October 22, 2002. Such written materials should be sent to the Lead Poisoning Prevention Program, Department of Public Health, Lucas State Office Building, Des Moines, Iowa 50319; E–mail to rgergely@idph.state.ia.us; fax (515)281– 4529.

Also, there will be a public hearing on October 22, 2002, at 11 a.m. (local Iowa time) over the Iowa Communications Network (ICN) at which time persons may present their views. The sites for the public hearing are as follows:

North Iowa Area Community College

Room 106, Activity Center

500 College Drive

Mason City

Iowa Valley Community College District

Room 806, Continuing Education Center

3702 South Center Street

Marshalltown

Department of Public Health

ICN Room, 6th Floor

Lucas State Office Building

321 East 12th Street

Des Moines

Green Valley Area Education Agency 14

Turner Room

1405 North Lincoln

Creston

Ottumwa Regional Health Center

Conference Room A

1001 East Pennsylvania

Ottumwa

Great River Area Education Agency 16

3601 West Avenue Road

Burlington

Department of Human Services

5th Floor, Room 550

411 3rd Street SE

Cedar Rapids

Eastern Iowa Community College

Kahl Educational Center, Room 304

326 West 3rd Street

Davenport

Council Bluffs Courthouse

Room 205–207, Federal Building

8 South 6th Street

Council Bluffs

Dubuque Downtown – Northeast Iowa
Community College

Room 101

700 Main Street

Dubuque

These rules are intended to implement Iowa Code sections 135.100 to 135.105.

The following amendment is proposed.

Rescind 641—Chapter 72 and adopt in lieu thereof the following new chapter:

CHAPTER 72
CHILDHOOD LEAD POISONING PREVENTION
PROGRAM

“Approved program” means a program that meets the requirements of subrule 72.2(3) and has been approved by the department.

“Capillary” means a blood sample taken from the finger or heel for lead analysis.

“Certified elevated blood lead (EBL) inspection agency” means an agency that has met the requirements of 641— 70.5(135) and has been certified by the department.

“Certified elevated blood lead (EBL) inspector/riskassessor” means a person who has met the requirements of 641—70.5(135) for certification or interim certification and who has been certified by the department.

“Chelation” means the administration of medication that binds lead so that it can be removed from the body.

“Department” means the Iowa department of public health.

“Elevated blood lead (EBL) child” means any child who has had one venous blood lead level greater than or equal to 20 micrograms per deciliter or at least two venous blood lead levels of 15 to 19 micrograms per deciliter.

“Elevated blood lead (EBL) inspection” means an inspection to determine the sources of lead exposure for an elevated blood lead (EBL) child and the provision within ten working days of a written report explaining the results of the investigation to the owner and occupant of the residential dwelling or child–occupied facility being inspected and to the parents of the elevated blood lead (EBL) child.

“Elevated blood lead (EBL) inspection agency” means an agency that employs or contracts with individuals who perform elevated blood lead (EBL) inspections. Elevated blood lead (EBL) inspection agencies may also employ or contract with individuals who perform other lead–based paint activities.

“Laboratory” means a laboratory satisfactorily participating in the blood lead analysis proficiency testing program of the Centers for Disease Control and Prevention/University of Wisconsin.

“Lead–based paint hazard” means hazardous lead–based paint, a dust–lead hazard, or a soil–lead hazard as defined in 641—Chapter 70.

“Local board” means a county, district, or city board of health.

“Local childhood lead poisoning prevention program” means a program in which the services listed in subrule 72.2(3) are provided by agencies located in a community.

“Venous” means a blood sample taken from a vein in the arm for lead analysis.

72.2(1) An individual local board of health representing a geographic area with a population of at least 15,000 is eligible to apply for status as an approved program. A group of local boards of health representing a geographic area with a total population of at least 15,000 may apply for status as an approved program by designating an individual local board of health to apply on behalf of the group.

72.2(2) A local board wishing to apply for status as an approved program shall make application to the Iowa department of public health by December 1 of each year, beginning on December 1, 2003, for the program year of July 1, 2004, through June 30, 2005. An application for status as an approved program must follow the format which will be made available from the Lead Poisoning Prevention Program, Iowa Department of Public Health, Lucas State Office Building, Des Moines, Iowa 50319–0075. All materials submitted as part of the application for status as an approved program are public records.

72.2(3) A local board applying for status as an approved program must demonstrate that it is prepared to provide the following activities and authority immediately upon the receipt of funding. The application submitted by a local board of health shall specify the name of the agency and of the individual staff member who will be responsible for carrying out each of the following activities:

a. A public education program about lead poisoning and the dangers of lead poisoning to children.

b. An effective outreach effort to ensure the availability of services in the geographic area to be served.

c. A blood lead testing program for children, with an emphasis on children less than six years of age. Blood lead testing should be done in conformance with the department’sstatewide blood lead testing plan, available on request from the department.

d. Provision of laboratory services, in conformance with the above–cited reference.

e. A program to ensure that children identified with blood lead levels greater than or equal to 10 micrograms per deciliter receive services appropriate for the blood lead level including, but not limited to, confirmatory venous blood lead testing, follow–up capillary or venous blood lead testing, nutrition counseling, a home nursing visit, a developmental evaluation, a medical evaluation, and chelation.

f. Elevated blood lead (EBL) inspections in dwelling units associated with an elevated blood lead (EBL) child. Elevated blood lead (EBL) inspections shall be conducted by certified elevated blood lead (EBL) inspector/risk assessors employed by or under contract with a certified elevated blood lead (EBL) inspection agency.

g. Follow–up inspections to ensure that lead–based paint hazards identified in dwelling units associated with an elevated blood lead (EBL) child are corrected.

h. Adoption and enforcement of a local code which provides adequate authority to require control of lead–based paint hazards found in dwelling units associated with an elevated blood lead (EBL) child.

i. Development of a community coalition to address childhood lead poisoning prevention.

j. Management of blood lead and case management data using the Strategic Tracking of Elevated Lead Levels and Remediation (STELLAR) program.

k. A plan of intent to continue the program on a maintenance basis after the grant is discontinued.

72.2(4) By January 1 of each year, the department shall notify each local board of health that has applied for status as an approved program whether the local board of health has been granted status as an approved program, beginning January 1, 2004, for the program year of July 1, 2004, through June 30, 2005.

72.2(5) A county that receives childhood lead poisoning prevention funding from the department for the program year of July 1, 2002, through June 30, 2003, shall have status as an approved program for the program year of July 1, 2003, through June 30, 2004. Unless the local board of health requests otherwise by March 1, 2003, the contractors that provide childhood lead poisoning prevention services in the county for the program year of July 1, 2002, through June 30, 2003, shall continue to serve as contractors for the program year of July 1, 2003, through June 30, 2004.

72.3(1) The department shall develop a formula to allocate funding to approved programs. In the development of the formula, the department shall consider factors that affect the burden of childhood lead poisoning in a geographic area including, but not limited to, the number of children under the age of six years, the percentage of housing built before 1950, the percentage of children in poverty, and the demonstrated prevalence of childhood lead poisoning in the geographic area to be served.

72.3(2) The department shall allocate state funds appropriated to the department for this program according to this formula. Federal funds available to the department for local childhood lead poisoning prevention programs shall be allocated to approved programs according to this formula unless a different method is mandated by the federal agency providing the funding.

72.3(3) The approved program shall provide one dollar for every three dollars of state funding awarded for each of the first two years of funding and then one dollar for each dollar of state funding awarded for the third and subsequent years of funding. Local contributions may be in the form of in–kind matching.

72.3(4) Matching requirements for federal funding allocated to approved programs shall be as mandated by the federal agency providing the funding.10/3/01

72.4(1) Any applicant that has timely filed an application and is aggrieved by the decision made pursuant to these rules regarding the applicant’s status as an approved program may request a reconsideration of the applicant’s proposal by filing a written request for reconsideration with the director of the Iowa department of public health. The request shall be filed within three working days of the date of notification of the decision regarding the applicant’s status as an approved program.

72.4(2) A request for reconsideration must be in writing and clearly state the reasons for reconsideration. The director’s scope of review for requests shall be limited to a finding that the department erred in following the rules or procedures of the approval process as outlined in these administrative rules.

72.4(3) The department shall refrain from allocating any funds until it has received the decision of the director as to any reconsideration. The review shall be conducted as expeditiously as possible so that all funds can be allocated in a timely fashion.

72.4(4) This procedure shall end the review process at the administrative level.

These rules are intended to implement Iowa Code sections 135.100 to 135.105.

Pursuant to the authority of Iowa Code chapter 17A and section 421.17(19), the Department of Revenue and Finance hereby gives Notice of Intended Action to amend Chapter 12, “Filing Returns, Payment of Tax, Penalty and Interest,” Chapter 13, “Permits,” Chapter 17, “Exempt Sales,” Chapter 18, “Taxable and Exempt Sales Determined by Method of Transaction or Usage,” Chapter 26, “Sales and Use Tax on Services,” Chapter 46, “Withholding,” Chapter 107, “Local Option Sales and Service Tax,” and Chapter 108, “Local Option School Infrastructure Sales and Service Tax,” Iowa Administrative Code.

Items 1 and 10 amend rule 701—12.13(422) and 701— subparagraph 46.3(3)“b”(4), respectively, based on 2002 Iowa Acts, House File 2622, sections 6, 11, and 14. These legislative changes provide the Department and the Iowa Department of Management the authority to change the statutory thresholds for sales and withholding taxes by Department rule. The changing of the thresholds allows the Department more flexibility based on Department need, budget and available resources, and provides benefits to various tax filers. In essence, due to budget reductions, the resources may not be available to process the volume of filers and deposit tax revenues as required by statute. Consequently, granting the Department the ability to change the thresholds will allow the number of monthly deposits and returns to be reduced. Conversely, there will be an increase in the number of filers in the semimonthly and quarterly periods. However, the net effect will be a reduction in the overall number of returns filed.

Item 2 amends 701—subrule 13.4(1) to implement 2002 Iowa Acts, Senate File 2305, section 8, which requires a schedule for consolidated sales tax returns and a penalty provision for failure to file a schedule.

Item 3 amends 701—subrule 17.9(1) and adds new 701— subrule 17.9(9) to implement 2002 Iowa Acts, Senate File 335, that classifies farm deer and bison as livestock, provides an exemption for farm deer and bison feed and additives, and allows for a retroactive refund of sales tax previously paid.

Item 4 amends 701—Chapter 17 to add two new rules, 701—17.40(422,423) and 701—17.41(422,423). New rule 701—17.40(422,423) is to implement 2002 Iowa Acts, House File 2622, section 9, to provide an exemption from sales tax for the purchase of tangible personal property and service for use by a community action agency as defined in Iowa Code section 216A.93. This item also adds new rule 701—17.41(422,423) to implement 2002 Iowa Acts, House File 2585, section 1, regarding the sale of items by the Legislative Service Bureau.

Item 5 amends rule 701—18.61(422,423) to implement 2002 Iowa Acts, House File 2305, section 9, to remove the sunset date for electronic and digital transfer of property.

Item 6 amends 701—subrules 26.8(1) and 26.8(2) to implement 2002 Iowa Acts, House File 2622, section 8, regarding the taxability of nonproprietary ATM transactions.

Item 7 amends rule 701—26.38(422,423) to remove the licensing requirement for executive search agencies.

Item 8 amends 701—subrule 26.68(3) to implement 2002 Iowa Acts, House File 2622, section 29, that clarifies thatairport–imposed fees are not part of the taxable gross receipts when renting a vehicle.

Item 9 amends 701—Chapter 26 to add a new rule 701— 26.81(422) to implement Iowa Code section 422.43 as amended by 2001 Iowa Acts, House File 736, section 1, regarding the taxability of bundled services.

Items 11 and 12 amend rules 701—107.10(422B) and 701—108.7(422E) to implement 2002 Iowa Acts, House File 2622, sections 12 and 13, which provide that the director has until August 15 of each fiscal year to send estimates of local option tax to jurisdictions, instead of having to send the estimates out within 15 days of the beginning of each fiscal year.

The proposed amendments will not necessitate additional expenditures by political subdivisions or agencies and entities which contract with political subdivisions.

Any person who believes that the application of the discretionary provisions of these amendments would result in hardship or injustice to that person may petition the Department for a waiver of the discretionary provisions, if any.

The Department has determined that these proposed amendments may have an impact on small business. The Department has considered the factors listed in Iowa Code section 17A.4A. The Department will issue a regulatory analysis as provided in Iowa Code section 17A.4A if a written request is filed by delivery or by mailing postmarked no later than November 4, 2002, to the Policy Section, Compliance Division, Department of Revenue and Finance, Hoover State Office Building, P.O. Box 10457, Des Moines, Iowa 50306. The request may be made by the Administrative Rules Review Committee, the Administrative Rules Coordinator, at least 25 persons signing that request who each qualify as a small business or an organization representing at least 25 such persons.

Any interested person may make written suggestions or comments on these proposed amendments on or before November 1, 2002. Such written comments should be directed to the Policy Section, Compliance Division, Department of Revenue and Finance, Hoover State Office Building, P.O. Box 10457, Des Moines, Iowa 50306.

Persons who want to convey their views orally should contact the Policy Section, Compliance Division, Department of Revenue and Finance, at (515)281–8036 or at the Department of Revenue and Finance offices on the fourth floor of the Hoover State Office Building.

Requests for a public hearing must be received by October 25, 2002.

These amendments are intended to implement Iowa Code sections 422.16 as amended by 2002 Iowa Acts, House File 2622, section 6; 422.42 as amended by 2002 Iowa Acts, Senate File 335; 422.43 as amended by 2001 Iowa Acts, chapter 150, section 1, and 2002 Iowa Acts, Senate File 2305, section 6; 422.45 as amended by 2002 Iowa Acts, Senate File 335, and House File 2622, section 9; 422.51 as amended by 2002 Iowa Acts, Senate File 2305, section 8; 422.54(1) as amended by 2002 Iowa Acts, House File 2622, section 11; 423.13 as amended by 2002 Iowa Acts, House File 2622, section 14; 422B.10 as amended by 2002 Iowa Acts, House File 2622, section 12; 422E.3 as amended by 2002 Iowa Acts, House File 2622, section 13; 516D.13 as amended by 2002 Iowa Acts, House File 2622, section 29; and 2002 Iowa Acts, House File 2585, section 1.

The following amendments are proposed.

ITEM 1. Amend rule 701—12.13(422) as follows:

12.13(1) Prior to January 1, 2003. Iowa Code sections 422.51(4) and 422.52 provide, based on the amount of tax collected, how often retailers file deposits or returns with the department (see rule 12.1(422)).

The department will determine if the retailer’s current filing status is correct by reviewing the most recent four quarters of the retailer’s filing history.

The following criteria will be used by the department to determine if a change in filing status is warranted.

When it is determined that a retailer’s filing status is to be changed, the retailer will be notified and will be given 30 days to provide the department with a written request to prevent the change.

Retailers may request that they be allowed to file less frequently than the filing status selected by the department but exceptions will only be granted in two instances:

1 a. Incorrect historical data is used in the conversion. A business may meet the criteria based on initial information available to the computer, but, upon investigation, the filing history may prove that the business does not meet the dollar criteria because of adjustments, amended returns, or requests for refunds.

2 b. Data available may have been distorted by the fact that it reflected an unusual pattern in tax collection. The factors causing such a distortion must be documented and approved by the excise tax division department.

Exceptions will not be granted in instances where the retailer’s request is based on a decline in business activity, reduction in employees or other potentially temporary business action which will affect current and future reporting.

Retailers will be notified in writing of approval or denial to of their request for reduced filing periods.

Retailers may request that they be allowed to file more frequently than the filing status selected by the department. Approval will be granted based upon justification contained in the retailer’s request.

12.13(2) January 1, 2003, and after. Effective July 1, 2002, the department and the department of management have the authority to change the above–mentioned filing thresholds established by department rule. After review of these filing thresholds, the department has determined that new thresholds are necessary and are to be implemented January 1, 2003. Accordingly, this subrule sets forth the filing thresholds for each filer based on the amount of sales tax collected.

The department and the department of management may perform review of filing thresholds every five years or as needed based on department discretion. Factors the departments will consider in determining if the filing thresholds need to be changed include, but are not limited to: tax rate changes, inflation, the need to maintain consistency with required multistate compacts, changes in law, and migration between filing brackets.

This rule is intended to implement Iowa Code sections 421.14, 422.51, and 422.52, and sections 422.54 as amended by 2002 Iowa Acts, House File 2622, section 11, and 423.13 as amended by 2002 Iowa Acts, House File 2622, section 14.

ITEM 2. Amend rule 701—13.4(422) as follows:

Amend subrule 13.4(1) by adding the following new unnumbered paragraph:

Effective July 1, 2002, in order to file a complete consolidated sales tax return, the taxpayer must file a form entitled Schedule of Consolidated Business Locations with its quarterly sales tax return, and the schedule must include all of the following items: (1) the taxpayer’s consolidated permit number; (2) the permit number for each Iowa location;(3) the amount of state sales tax by business location; and(4) the amount of state sales tax due on goods consumed that are not assigned to a specific business location. Failure by the taxpayer to file a Schedule of Consolidated Business Locations form with a quarterly sales tax return will result in the quarterly return’s being considered incomplete, and the taxpayer will be subject to the penalty provisions set forth in Iowa Code section 421.27.

Amend the implementation clause as follows:

This rule is intended to implement Iowa Code section 422.51 as amended by 1999 Iowa Acts, chapter 156, 2002 Iowa Acts, Senate File 2305, section 8, and Iowa Code section 422.53.

ITEM 3. Amend rule 701—17.9(422,423) by amending the introductory paragraph of subrule 17.9(1), adding new subrule 17.9(9) and amending the implementation clause as follows:

17.9(1) Sales of agricultural breeding livestock. “Livestock” means domestic animals which are raised on a farm as a source of food or clothing, Van Clief v. Comptroller of State of Md., 126 A.2d 865 (Md. 1956) and In the Matter ofSimonsen Mill Inc., Declaratory Ruling of the State Board, Docket No. 211, April 24, 1980. The term includes cattle, sheep, hogs, and goats. On and after July 1, 1995, ostriches, rheas, and emus are livestock and their sales are also exempt from tax. On and after July 1, 1997, fish and any other animals which are products of aquaculture are considered to be livestock as well. Effective March 6, 2002, and retroactively to April 1, 1995, farm deer and bison are also included in the term “livestock.” “Farm deer” are defined as set forth in Iowa Code section 189A.2 and commonly include animals belonging to the cervidae family, such as fallow deer, red deer or elk and sika. However, “farm deer” does not include unmarked free–ranging elk. Their sales Sales of the foregoing are exempt from tax. Excluded from the term are horses, mules, other draft animals, dogs, cats, and other pets. Also excluded from the term are mink, fish (prior to July 1, 1997), bees, or other non–domesticated animals even if raised in captivity and even if raised as a source of food or clothing. Also excluded is any animal raised for racing.

17.9(9) Refunds regarding farm deer and bison. Effective March 6, 2002, and retroactive to April 1, 1995, refunds of tax, penalty or interest may be claimed for sale of feed and feed supplements and additives when used for consumption by farm deer or bison. To be eligible for refund, the sale must have occurred between April 1, 1995, and March 6, 2002, and the refund claim must be filed prior to October 1, 2002. Refund claims are limited to $50,000 in aggregate and will not be allowed if not timely filed. If the amount of claims totals more than $50,000 in aggregate, the department will prorate the $50,000 among all the claimants in relation to the amounts of the claimants’ valid claims.

This rule is intended to implement Iowa Code sections 422.42 as amended by 2002 Iowa Acts, Senate File 335, 422.43, and 423.1 as amended by 1997 Iowa Acts, House File 266 and Senate File 30.