IOWA ADMINISTRATIVEBULLETIN
Published Biweekly VOLUME XXII NUMBER 15 January
26, 2000 Pages 1109 to 1188
CONTENTS IN THIS ISSUE
Pages 1123 to 1186 include ARC 9611A to ARC
9636A
AGENDA
Administrative rules review committee 1114
ALCOHOLIC BEVERAGES DIVISION[185]
COMMERCE
DEPARTMENT[181]“umbrella”
Notice, Waivers from rules, ch 19 ARC
9621A 1123
ALL AGENCIES
Schedule for rule making 1112
Publication procedures 1113
Administrative rules on CD–ROM 1113
Agency identification numbers 1120
CITATION OF ADMINISTRATIVE RULES 1111
EMERGENCY MANAGEMENT DIVISION[605]
PUBLIC DEFENSE
DEPARTMENT[601]“umbrella”
Notice, Enhanced wireless 911 service plan,
10.7 ARC
9632A 1124
Filed Emergency, Enhanced wireless 911
service plan, 10.7
ARC 9633A 1180
EXECUTIVE COUNCIL[361]
Filed, Disbursement of money from civil
reparations trust
fund, ch 12 ARC 9634A 1182
HUMAN SERVICES DEPARTMENT[441]
Notice, Rent subsidy program, 53.2(2), 53.3(2),
53.4(2)
ARC 9612A 1125
Notice, AEA services under Medicaid, 78.32
ARC
9613A 1126
Notice, Placement and readmission criteria—
highly
structured residential facilities, 114.2,
185.83(4) ARC
9614A 1126
Notice, Rehabilitative treatment and supportive
services
contract—effective date, 152.8,
152.22(6) ARC
9615A 1128
INSPECTIONS AND APPEALS DEPARTMENT[481]
Notice, Uniform waiver and variance rules, ch 6
ARC
9625A 1128
Notice, Food stamp overpayments, 71.6(2)
ARC
9611A 1131
INSURANCE DIVISION[191]
COMMERCE
DEPARTMENT[181]“umbrella”
Filed, Viatical settlement contracts,
50.120 to 50.124
ARC 9616A 1183
LABOR SERVICES DIVISION[875]
WORKFORCE DEVELOPMENT
DEPARTMENT[871]“umbrella”
Notice, Waivers from administrative rules,
1.101 to 1.109
ARC 9631A 1131
Filed Emergency After Notice, General
industry, 10.20
ARC 9619A 1180
Filed Emergency After Notice, Construction
safety and
health, 26.1 ARC 9620A 1181
LOTTERY DIVISION[705]
REVENUE AND FINANCE
DEPARTMENT[701]“umbrella”
Filed, Suspension or revocation of license,
2.12 ARC
9624A 1185
MEDICAL EXAMINERS BOARD[653]
PUBLIC HEALTH
DEPARTMENT[641]“umbrella”
Notice, Supervision of pharmacists who
administer
prescription drugs, 13.3 ARC 9618A 1133
NATURAL RESOURCE COMMISSION[571]
NATURAL RESOURCES
DEPARTMENT[561]“umbrella”
Filed Emergency, Shooting ranges on game
management areas,
51.3(1) ARC 9628A 1181
NATURAL RESOURCES DEPARTMENT[561]
Notice, Waivers or variances from
administrative rules, ch
10 ARC 9627A 1134
PERSONNEL DEPARTMENT[581]
Notice, Uniform rules for waivers and variances,
ch 32
ARC 9626A 1136
PUBLIC FUNDS—AVAILABILITY
Public Health Department[641]
Critical access hospital
grant program 1122
PUBLIC HEALTH DEPARTMENT[641]
Notice of Public Funds Availability 1122
Notice, Radiation, amendments to
chs 38 to 42, 45, 46
ARC 9629A 1138
PUBLIC HEALTH DEPARTMENT[641](Cont’d)
Notice, WIC program, 73.5, 73.8, 73.9,
73.12(1), 73.19,
73.20 ARC 9623A 1165
PUBLIC HEARINGS
Summarized list 1117
PUBLIC SAFETY DEPARTMENT[661]
Public Notice 1174
REVENUE AND FINANCE DEPARTMENT[701]
Filed, Property tax, 71.1, 71.25, 73.1, 73.10,
73.14,
73.27(3), 73.29, 74.4, 75.6, 75.7, 77.1,
78.1(1), 78.4, 79.1, 79.5, 80.2,
80.4, 80.14
ARC 9635A 1185
Filed, Local option sales and service tax;
local option
school infrastructure sales
and service tax, 107.2, 107.8 to
107.10,
107.14, 108.1 to 108.9 ARC 9636A 1186
TRANSPORTATION DEPARTMENT[761]
Notice, Waiver of rules, 10.1(2), ch 11,
112.1(2),
115.1(2), 524.2(2), 529.3 ARC 9617A 1174
Notice, Flashing lights and warning devices
on
slow–moving vehicles, ch 452
ARC 9622A 1176
TREASURER OF STATE
Notice—Public funds interest rates 1177
WORKFORCE
DEVELOPMENT
DEPARTMENT[871]
Notice, Request for waiver of administrative
rule,
23.40(2), ch 41 ARC 9630A 1178
PUBLISHED UNDER
AUTHORITY OF IOWA
CODE SECTIONS 2B.5 AND
17A.6
__________________________________
PREFACE
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:
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KATHLEEN K. BATES, Administrative Code
Editor Telephone: (515)281–3355
STEPHANIE A. HOFF, Assistant
Editor (515)281–8157
Fax: (515)281–4424
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Schedule for Rule
Making
2000
NOTICE SUBMISSION
DEADLINE
|
NOTICE PUB.
DATE
|
HEARING OR COMMENTS 20
DAYS
|
FIRST POSSIBLE ADOPTION
DATE 35 DAYS
|
ADOPTED FILING DEADLINE
|
ADOPTED PUB.
DATE
|
FIRST POSSIBLE
EFFECTIVE DATE
|
POSSIBLE EXPIRATION OF NOTICE 180
DAYS
|
Dec. 24 ’99
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Jan. 12 ’00
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July 26
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PRINTING SCHEDULE FOR IAB
|
ISSUE NUMBER
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SUBMISSION DEADLINE
|
ISSUE DATE
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|
Friday, February 4, 2000
|
February 23, 2000
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|
Friday, February 18, 2000
|
March 8, 2000
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Friday, March 3, 2000
|
March 22, 2000
|
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.
PUBLICATION PROCEDURES
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
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______________________
IOWA ADMINISTRATIVE RULES and IOWA COURT RULES on
CD–ROM
1999 SUMMER EDITION
Containing: Iowa Administrative Code (updated through
June 1999)
Iowa Administrative Bulletins (January 1999 through June
1999)
Iowa Court Rules (updated through June 1999)
For free brochures and order forms contact:
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Telephone:
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AGENDA
The Administrative Rules Review Committee will hold a special
meeting on Friday, February 4, 2000, at9 a.m. in Room 118, State Capitol, Des
Moines, Iowa. The following rules will be reviewed:
Bulletin
AGRICULTURE AND LAND STEWARDSHIP
DEPARTMENT[21]
Prohibit movement of infested bees from
designated states; inspection required for the sale of
bees,
comb, or used equipment, 22.10, 22.11,
Filed ARC 9596A 1/12/00
ALCOHOLIC BEVERAGES DIVISION[185]
COMMERCE
DEPARTMENT[181]“umbrella”
Waivers from rules, ch 19, Notice
ARC 9621A 1/26/00
ECONOMIC DEVELOPMENT, IOWA DEPARTMENT OF[261]
Uniform waiver and variance rules, ch 104,
Notice ARC 9598A 1/12/00
EMERGENCY MANAGEMENT DIVISION[605]
PUBLIC DEFENSE
DEPARTMENT[601]“umbrella”
Enhanced wireless 911 service plan, 10.7,
Notice ARC 9632A, also Filed Emergency ARC
9633A 1/26/00
ENGINEERING AND LAND SURVEYING EXAMINING
BOARD[193C]
Professional Licensing and Regulation
Division[193]
COMMERCE
DEPARTMENT[181]“umbrella”
Land surveys, 2.5(3), 2.6, 2.8, Filed
ARC 9601A 1/12/00
ENVIRONMENTAL PROTECTION COMMISSION[567]
NATURAL RESOURCES
DEPARTMENT[561]“umbrella”
Animal feeding operations, 65.16(3),
65.19(6)“b”(1), Filed Emergency ARC
9599A 1/12/00
EXECUTIVE COUNCIL[361]
Disbursement of money from civil reparations
trust fund, ch 12, Filed ARC 9634A 1/26/00
GENERAL SERVICES DEPARTMENT[401]
Fees paid to newspapers, 5.21, Filed
ARC 9602A 1/12/00
HUMAN SERVICES DEPARTMENT[441]
Waivers of administrative rules, 1.8,
Notice ARC 9597A 1/12/00
Rent subsidy program, 53.2(2), 53.3(2), 53.4(2),
Notice ARC 9612A 1/26/00
Coverage of area education agency services under
Medicaid, 78.32, Notice ARC 9613A 1/26/00
Highly structured juvenile programs, 114.2,
185.83(4), Notice ARC 9614A 1/26/00
Effective date of rehabilitative treatment and
supportive services contract, 152.8, 152.22(6), Notice ARC
9615A 1/26/00
INSPECTIONS AND APPEALS DEPARTMENT[481]
Uniform waiver and variance rules, ch 6,
Notice ARC 9625A 1/26/00
Quality award for nursing facilities, ch 54,
Notice ARC 9610A 1/12/00
Collection of food stamp overpayments, 71.6(2),
Notice ARC 9611A 1/26/00
INSURANCE DIVISION[191]
COMMERCE
DEPARTMENT[181]“umbrella”
Reconstructive surgery; licensure requirement for
health care professionals who are not
medical
professionals; community health management
information system, 35.35, 71.23,
75.17,
76.9(1)“c,” rescind ch 100,
Notice ARC 9594A 1/12/00
Valuation of life insurance policies, ch 47,
Filed ARC 9609A 1/12/00
Viatical settlement contracts, 50.120 to 50.124,
Filed ARC 9616A 1/26/00
LABOR SERVICES DIVISION[875]
WORKFORCE DEVELOPMENT
DEPARTMENT[871]“umbrella”
Waivers from administrative rules, ch 1 division
VI, 1.100, ch 1 division VII, 1.101 to 1.109, Notice ARC
9631A 1/26/00
General industry safety and health, 10.20,
Filed Emergency After Notice ARC 9619A 1/26/00
Construction safety and health, 26.1, Filed
Emergency After Notice ARC 9620A 1/26/00
LOTTERY DIVISION[705]
REVENUE AND FINANCE
DEPARTMENT[701]“umbrella”
Suspension or revocation of a license, 2.12,
Filed ARC 9624A 1/26/00
MEDICAL EXAMINERS BOARD[653]
PUBLIC HEALTH
DEPARTMENT[641]“umbrella”
Uniform waiver and variance; licensure
application waivers, ch 3, 11.9(3), Notice ARC
9605A 1/12/00
Supervision of pharmacists who administer
prescription drugs, 13.3, Notice ARC
9618A 1/26/00
NATURAL RESOURCE COMMISSION[571]
NATURAL RESOURCES
DEPARTMENT[561]“umbrella”
Shooting ranges located on game management areas,
51.3(1), Filed Emergency ARC 9628A 1/26/00
NATURAL RESOURCES DEPARTMENT[561]
Waivers or variances from administrative rules,
ch 10, Notice ARC 9627A 1/26/00
NURSING BOARD[655]
PUBLIC HEALTH
DEPARTMENT[641]“umbrella”
Nursing education programs, 2.1, 2.10, 2.11,
Notice ARC 9607A 1/12/00
PERSONNEL DEPARTMENT[581]
Uniform rules for waivers and variances, ch 32,
Notice ARC 9626A 1/26/00
PROFESSIONAL LICENSURE DIVISION[645]
PUBLIC HEALTH
DEPARTMENT[641]“umbrella”
Dietetic examiners, 80.5(1), 80.5(4), 80.100(4),
80.101(1), 80.101(2)“d,” 80.101(3),
80.101(8),
80.102(1), 80.104, Filed ARC
9606A 1/12/00
PUBLIC HEALTH DEPARTMENT[641]
Radiation, ch 38 title, 38.1(2), 38.2, 38.3(1),
38.8(1)“a,” 38.8(3)“a,” 38.8(6), 38.10, 39.1(3),
39.3(2)“a,”
39.3(3)“d,”
39.3(10)“a,” 39.4(24), 39.4(26)“e,”
39.4(26)“f”(2) and (5), 39.4(27)“e,”
39.4(33)“j”(2),
39.4(33)“k”(3),
39.4(90)“a”(3), 39.5, ch 39 appendices E, H, I, and J, 40.1(5),
40.2(2), 40.10(2),
40.15(1)“b”(1), 40.15(3),
40.20(1), 40.22, 40.36(1)“b”(1), 40.62(2), 40.62(5), 40.75, 40.80,
ch 40 appendix D,
41.1(1), 41.1(2),
41.1(3)“a”(6), 41.1(3)“f”(1)“2,”
41.1(3)“f”(2)“1,” 41.1(3)“f”(4),
41.1(4)“i,” 41.1(6),
41.1(6)“h”(1)“3,”
41.1(7)“c”(5),
41.1(9)“e” to “g,” 41.1(11)“a,”
41.2(14)“c,” 41.2(60)“a”(2)“1” and
“2,” 41.2(62),
41.3(1)“b,”
41.3(2), 41.3(12), 41.3(13),
41.3(17)“a”(1)“3,” 41.3(18)“a”(15),
41.3(18)“e,” 41.3(18)“f”(1) and (3),
41.6(1),
41.6(2)“a”(8),
41.6(2)“c,” 41.6(3), 41.6(4), 41.6(5)“a,”
“c,” “h” to “o,” 41.6(6), 41.6 appendix I,
41.7(1),
ch 41 appendix B“3,”
42.2(2)“f,” 42.3(1)“a”(7), 45.1(2),
45.1(5)“c,” 45.1(7), 45.1(9)“b,”
45.1(10)“b”(1)“2,”
45.1(10)“d,”
45.1(10)“g”(1)“1,” 45.1(11), 45.1(12)“b,”
45.1(13), 45.3(1), 45.3(2)“a,” 45.3(4)“c”(5) and
(8),
45.3(4)“f” and “g,”
45.3(5)“b,” 45.3(6)“a”(9) to (12),
45.3(6)“c,” 45.3(7)“b,” 45.3(9)“a,”
45.3(11), 45.4(2),
45.4(11)“c,” 46.1,
46.5(1)“c,” Notice ARC
9629A 1/26/00
Special supplemental nutrition program for women,
infants, and children (WIC), 73.5, 73.8, 73.8(1),
73.8(2),
73.8(4), 73.8(5), 73.9(2)“c”(1),
73.9(3)“c,” 73.9(3)“d”(4), 73.9(3)“e,”
73.9(3)“f”(3), 73.12(1), 73.19(1),
73.19(2),
73.20, Notice ARC 9623A 1/26/00
REAL ESTATE COMMISSION[193E]
Professional Licensing and Regulation
Division[193]
COMMERCE
DEPARTMENT[181]“umbrella”
Business conduct, 1.1, 1.27(1)“c,”
1.27(15), 1.41,1.42(6)“i” and “j,” Notice
ARC 9600A 1/12/00
REVENUE AND FINANCE DEPARTMENT[701]
Individual income tax and withholding tax,
39.2(4)“b,” 40.18(9), 42.2(6),
42.2(10),
43.8(2)“o,” 46.3(3)“e,”
Filed ARC 9608A 1/12/00
Property tax, 71.1, 71.1(4), 71.1(5),
71.25(2)“c” and “d,” 73.1, 73.10, 73.14, 73.27(3),
73.29, 74.4(2),
74.4(3), 75.6, 75.7, 77.1(1), 78.1(1),
78.4(1), 78.4(1)“e,” 78.4(2) to 78.4(4), 79.1(6), 79.5(6),
80.2,
80.2(1)“a,” 80.2(2)“c,”
“e,” and “g,” 80.4, 80.14, Filed ARC
9635A 1/26/00
Local option sales and service tax; local option
school infrastructure sales and service tax, 107.2, 107.8 to
107.10,
107.14, 108.2(3), 108.2(5), 108.2(6), 108.5,
108.7 to 108.9, Filed ARC 9636A 1/26/00
SECRETARY OF STATE[721]
Election forms and instructions—plan III
supervisor district candidate signatures after a
change
in the number of supervisors, 21.601,
Notice ARC 9604A, also Filed Emergency ARC
9603A 1/12/00
TRANSPORTATION DEPARTMENT[761]
Waiver of rules, 10.1(2), ch 11, 112.1(2),
115.1(2), 524.2(2), 529.3, Notice ARC
9617A 1/26/00
Flashing lights and warning devices on
slow–moving vehicles, ch 452 title, 452.1 to 452.3, Notice
ARC 9622A 1/26/00
Rail assistance program; railroad revolving loan
fund, 830.2(2), 830.3(1), 830.3(2), 830.4(2),
830.4(4)“b,”
830.6(4), 830.6(5), ch 831,
Filed ARC 9593A 1/12/00
VOTER REGISTRATION COMMISSION[821]
State registrar of voters, 1.2, Filed
ARC 9595A 1/12/00
WORKFORCE DEVELOPMENT DEPARTMENT[871]
Extension of contribution surcharge to year 2001;
request for waiver of administrative rule, 23.40(2)“a,” ch
41,
Notice ARC
9630A 1/26/00
ADMINISTRATIVE RULES REVIEW COMMITTEE
MEMBERS
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.
EDITOR’S NOTE: Terms ending April 30,
2003.
Senator H. Kay Hedge
3208 335th Street
Fremont, Iowa 52561
|
Representative Janet Metcalf
12954 Oak Brook Drive
Urbandale, Iowa 50323
|
Senator Merlin E. Bartz
2081 410th Street
Grafton, Iowa 50440
|
Representative Clyde Bradley
835 Blackhawk Lane
Camanche, Iowa 52730
|
Senator Patricia M. Harper
3336 Santa Maria Drive
Waterloo, Iowa 50702
|
Representative Danny Carroll
244 400th Avenue
Grinnell, Iowa 50112
|
Senator John P. Kibbie
P.O. Box 190
Emmetsburg, Iowa 50536
|
Representative Minnette Doderer
2008 Dunlap Court
Iowa City, Iowa 52245
|
Senator Sheldon Rittmer
3539 230th Street
DeWitt, Iowa 52742
|
Representative Geri Huser
213 7th Street NW
Altoona, Iowa 50009
|
Joseph A. Royce
Legal Counsel
Capitol, Room 116A
Des Moines, Iowa 50319
Telephone (515)281–3084
Fax (515)281–5995
|
Brian Gentry
Administrative Rules Coordinator
Governor’s Ex Officio Representative
Capitol, Room 11
Des Moines, Iowa 50319
|
|
|
PUBLIC HEARINGS
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.
AGENCY
|
HEARING LOCATION
|
DATE AND TIME OF HEARING
|
EMERGENCY MANAGEMENT DIVISION[605]
|
|
Enhanced wireless 911 service plan, 10.7 IAB 1/26/00
ARC 9632A (See also ARC 9633A
herein)
|
Conference Room—Level A Hoover State Office
Bldg. Des Moines, Iowa
|
February 15, 2000 10 a.m.
|
INSPECTIONS AND APPEALS DEPARTMENT[481]
|
|
Quality award for nursing facilities, ch 54 IAB 1/12/00
ARC 9610A
|
Director’s Conference Room Second Floor Lucas
State Office Bldg. Des Moines, Iowa
|
February 8, 2000 10 a.m.
|
LABOR SERVICES DIVISION[875]
|
|
Waivers from administrative rules, 1.101 to 1.109 IAB
1/26/00 ARC 9631A
|
Division of Labor Services 1000 E. Grand Ave. Des
Moines, Iowa
|
February 15, 2000 1:30 p.m. (If
requested)
|
MEDICAL EXAMINERS BOARD[653]
|
|
Supervision of pharmacists who administer prescription
drugs, 13.3 IAB 1/26/00 ARC 9618A
|
Auditorium State Historical Building 600 E. Locust
St. Des Moines, Iowa
|
February 15, 2000 1 p.m.
|
NURSING BOARD[655]
|
|
Examinations, 2.10 IAB 1/12/00 ARC
9607A
|
Ballroom Kirkwood Civic Center Hotel 4th and
Walnut Des Moines, Iowa
|
March 1, 2000 7 p.m.
|
PERSONNEL DEPARTMENT[581]
|
|
Uniform rules for waivers and variances, ch 32 IAB
1/26/00 ARC 9626A
|
IPERS 600 E. Court Ave. Des Moines, Iowa
|
February 15, 2000 9 a.m.
|
PUBLIC HEALTH DEPARTMENT[641]
|
|
Radiation, amendments to chs 38 to 42, 45, 46 IAB
1/26/00 ARC 9629A
|
Conference Room—5th Floor South Side 1 Lucas State
Office Bldg. Des Moines, Iowa
|
February 29, 2000 8:30 a.m.
|
PUBLIC HEALTH DEPARTMENT[641] (Cont’d)
|
WIC program, 73.5, 73.8, 73.9, 73.12(1), 73.19,
73.20 IAB 1/26/00 ARC 9623A (ICN Network)
|
ICN Classroom 1, Room 0210 Scott Community College 500
Belmont Rd. Bettendorf, Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
|
ICN Classroom National Guard Armory 2500 Summer
St. Burlington, Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
|
Schindler Education Center 130A UNI Hudson Rd. and 23rd
St. Cedar Falls, Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
|
Jefferson High School 1243 20th St. SW Cedar Rapids,
Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
|
ICN Classroom Clear Lake High School 125 N. 20th
St. Clear Lake, Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
|
ICN Classroom 1 Southwestern Community College 1501 W.
Townline Rd. Creston, Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
|
Room 115, Trade Industry Bldg. Northeast Iowa Community
College 1625 Hwy. 150 Calmar, Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
|
Conference Room—6th Floor Lucas State Office
Bldg. Des Moines, Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
|
Room 22, Library Bldg. Iowa Lakes Community College 300
S. 18th St. Estherville, Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
|
Army Aviation Support Facility 1649 Nelson Ave. Fort
Dodge, Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
|
ICN Room National Guard Armory 2858 N. Court
Rd. Ottumwa, Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
|
Forum Bldg.—2nd Floor Dubuque Community School
District 2300 Chaney Dubuque, Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
|
Individual Learning Center Central Campus 1121 Jackson
St. Sioux City, Iowa
|
February 15, 2000 12 noon to 1 p.m.
|
REAL ESTATE COMMISSION[193E]
|
|
Business conduct, 1.1, 1.27, 1.41, 1.42(6) IAB 1/12/00
ARC 9600A
|
Conference Room—2nd Floor Commerce Bldg. 1918 SE
Hulsizer Ankeny, Iowa
|
February 1, 2000 9 a.m.
|
SECRETARY OF STATE[721]
|
|
Signature requirements for nomination petitions
for supervisor candidates, 21.601 IAB 1/12/00 ARC
9604A (See also ARC 9603A)
|
Office of the Secretary of State Second Floor Hoover
State Office Bldg. Des Moines, Iowa
|
February 1, 2000 1:30 p.m.
|
TRANSPORTATION DEPARTMENT[761]
|
|
Waiver of rules, 10.1(2), ch 11, 112.1(2), 115.1(2),
524.2(2), 529.3 IAB 1/26/00 ARC 9617A
|
Commission Conference Room 800 Lincoln Way Ames,
Iowa
|
February 17, 2000 1 p.m. (If
requested)
|
Flashing lights and warning devices on slow–moving
vehicles, ch 452 IAB 1/26/00 ARC 9622A
|
Commission Conference Room 800 Lincoln Way Ames,
Iowa
|
February 17, 2000 2 p.m. (If
requested)
|
WORKFORCE DEVELOPMENT DEPARTMENT[871]
|
|
Request for waiver of administrative rule, 23.40(2), ch
41 IAB 1/26/00 ARC 9630A
|
Unemployment Insurance Svcs. Div. 1000 E. Grand Ave. Des
Moines, Iowa
|
February 15, 2000 9:30 a.m.
|
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
AGENCY IDENTIFICATION
NUMBERS
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]
BEEF INDUSTRY COUNCIL, IOWA[101]
BLIND, DEPARTMENT FOR THE[111]
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]
EGG COUNCIL[301]
ELDER AFFAIRS DEPARTMENT[321]
EMPOWERMENT BOARD, IOWA[349]
ETHICS AND CAMPAIGN DISCLOSURE BOARD,
IOWA[351]
EXECUTIVE COUNCIL[361]
FAIR BOARD[371]
GENERAL SERVICES DEPARTMENT[401]
HUMAN INVESTMENT COUNCIL[417]
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]
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]
LIVESTOCK HEALTH ADVISORY
COUNCIL[521]
MANAGEMENT DEPARTMENT[541]
Appeal Board, State[543]
City Finance Committee[545]
County Finance Committee[547]
NARCOTICS ENFORCEMENT ADVISORY
COUNCIL[551]
NATIONAL AND COMMUNITY SERVICE, IOWA COMMISSION
ON[555]
NATURAL RESOURCES DEPARTMENT[561]
Energy and Geological Resources Division[565]
Environmental Protection Commission[567]
Natural Resource Commission[571]
Preserves, State Advisory Board[575]
PERSONNEL DEPARTMENT[581]
PETROLEUM UNDERGROUND STORAGE TANK
FUND
BOARD, IOWA COMPREHENSIVE[591]
PREVENTION OF DISABILITIES POLICY
COUNCIL[597]
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]
RECORDS COMMISSION[671]
REGENTS BOARD[681]
Archaeologist[685]
REVENUE AND FINANCE DEPARTMENT[701]
Lottery Division[705]
SECRETARY OF STATE[721]
SEED CAPITAL CORPORATION,
IOWA[727]
SHEEP AND WOOL PROMOTION BOARD,
IOWA[741]
TELECOMMUNICATIONS AND TECHNOLOGY COMMISSION,
IOWA[751]
TRANSPORTATION DEPARTMENT[761]
Railway Finance Authority[765]
TREASURER OF STATE[781]
TURKEY MARKETING COUNCIL,
IOWA[787]
UNIFORM STATE LAWS
COMMISSION[791]
VETERANS AFFAIRS COMMISSION[801]
VETERINARY MEDICINE BOARD[811]
VOTER REGISTRATION
COMMISSION[821]
WORKFORCE DEVELOPMENT DEPARTMENT[871]
Labor Services Division[875]
Workers’ Compensation Division[876]
Workforce Development Board and
Workforce Development
Center Administration Division[877]
NOTICES
ARC 9621A
ALCOHOLIC BEVERAGES
DIVISION[185]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code section 123.21, the
Alcoholic Beverages Division hereby gives Notice of Intended Action to adopt
Chapter 19, “Waivers from Rules,” Iowa Administrative
Code.
The purpose of proposed Chapter 19 is to satisfy the
requirements of Executive Order Number 11 which requires state agencies to adopt
a general waiver rule.
Consistent with Executive Order Number 9, the Division has
considered the regulatory principles identified in this order and finds that
this chapter will serve an important public need in making the rules of the
Division more flexible in application to specific circumstances.
Proposed Chapter 19 provides for the general requirements for
requesting a waiver and describes the procedure the Division will use to grant a
waiver.
The Division will receive written comments on the proposed
chapter until the close of business on February 16, 2000. Comments may be
addressed to Judy K. Seib, Alcoholic Beverages Division, 1918 S.E. Hulsizer
Road, Ankeny, Iowa 50021. Comments may be faxed to Judy K. Seib at
(515)281–7375. Comments may be E–mailed to Judy K. Seib at
Judy.Seib@comm2.state.ia.us.
This chapter is intended to implement Executive Order Number
11.
The following amendment is proposed.
Adopt the following new chapter:
CHAPTER 19
WAIVERS FROM RULES
185—19.1(123) Applicability. This chapter
outlines a uniform process for the granting of waivers from rules adopted by the
division.
19.1(1) Authority. A waiver from rules adopted by the
alcoholic beverages division may be granted in accordance with this chapter
if:
a. The division has exclusive rule–making authority to
promulgate the rule from which a waiver is requested or has final
decision–making authority over a contested case in which a waiver is
requested; and
b. No statute or rule otherwise controls the granting of a
waiver from the rule from which a waiver is requested.
19.1(2) Interpretive rules. This chapter shall not
apply to rules that merely define the meaning of a statute or other provisions
of law or precedent if the division does not possess delegated authority to bind
the courts to any extent with its definition.
185—19.2(123) Compliance with statute. No
waiver may be granted from a requirement that is imposed by statute. Any waiver
must be consistent with statute.
185—19.3(123) Criteria for waiver. The division
may issue an order, in response to a completed petition or on its own motion,
granting a waiver from a rule adopted by the division, in whole or in part, as
applied to the circumstances of a specified person if the division finds
that:
1. Application of the rule to the person at issue would result
in hardship or injustice to that person; and
2. Waiver on the basis of the particular circumstances
relative to that specified person would be consistent with the public interest;
and
3. Waiver in the specific case would not prejudice the
substantial legal rights of any person.
In determining whether a waiver would be consistent with the
public interest under “2,” the division shall consider whether, if
the waiver is granted, the public health and safety will be protected by other
means that are substantially equivalent to full compliance with the
rule.
19.3(1) Division discretion. The decision on whether
the circumstances justify the granting of a waiver shall be made at the sole
discretion of the division, upon consideration of all relevant
factors.
19.3(2) Mandatory waivers. In response to the timely
filing of a completed petition requesting a waiver, the division shall grant a
waiver from a rule, in whole or in part, as applied to the particular
circumstances of a specified person, if the division finds that the application
of all or a portion thereof to the circumstances of that specified person would
not, to any extent, advance or serve any of the purposes of the rule.
19.3(3) Burden of persuasion. The petitioner shall
assume the burden of persuasion when a petition is filed for a waiver from a
division rule.
19.3(4) Special waiver rules not precluded. This
chapter shall not preclude the division from granting waivers in other contexts
or on the basis of other standards if a statute or other division rule
authorizes the division to do so, and the division deems it appropriate to do
so.
19.3(5) Administrative deadlines. When the rule from
which a waiver is sought establishes administrative deadlines, the division
shall balance the special individual circumstances of the petitioner with the
overall goal of uniform treatment of all licensees and license
applicants.
185—19.4(123) Filing of petition. A petition
for a waiver must be submitted in writing to the division as follows:
19.4(1) License application. If the petition relates
to a license application, the petition shall be made in accordance with the
filing requirements for the license in question.
19.4(2) Contested cases. If the petition relates to a
pending contested case, the petition shall be filed in the contested case
proceeding.
19.4(3) Other. If the petition does not relate to a
license application or a pending contested case, the petition may be submitted
to the division administrator.
185—19.5(123) Content of petition. A petition
for waiver shall include the following information where applicable and known to
the requester:
1. The name, address, and telephone number of the person or
entity for whom a waiver is being requested and the license number or case
number of any related contested case.
2. A description and citation of the specific rule from which
a waiver is requested.
3. The specific waiver requested, including the precise scope
and operative period that the waiver will extend.
4. The relevant facts that the petitioner believes would
justify a waiver. This statement shall include a signed statement from the
petitioner attesting to the accuracy of the facts provided in the petition, and
a statement of reasons that the petitioner believes will justify a
waiver.
5. A history of any prior contacts between the division and
the petitioner relating to the regulated activity or license affected by the
proposed waiver, including:
• A description of each
affected license held by the requester.
• Any notices of violation,
contested case hearings, or investigative reports relating to the regulated
activity or license.
6. Any information known to the requester regarding the
division’s treatment of similar cases.
7. The name, address, and telephone number of any public
agency or political subdivision which also regulates the activity in question,
or which might be affected by the granting of a waiver.
8. The name, address, and telephone number of any person or
entity that would be adversely affected by the granting of a petition.
9. The name, address, and telephone number of any person with
knowledge of the relevant facts relating to the proposed waiver.
10. Signed releases of information authorizing persons with
knowledge regarding the request to furnish the division with information
relevant to the waiver.
185—19.6(123) Additional information. Prior to
issuing an order granting or denying a waiver, the division may request
additional information from the petitioner relative to the petition and
circumstances relating to the request for waiver. If the petition was not filed
in a contested case, the division may, on its own motion or at the
petitioner’s request, schedule a telephonic or in–person hearing
between the petitioner and the division administrator.
185—19.7(123) Notice. The division shall
acknowledge a petition upon receipt. The division shall ensure that notice of
the pendency of the petition and a concise summary of its contents have been
provided to all persons to whom notice is required by any provision of law,
within 30 days of the receipt of the petition. In addition, the division may
give notice to other persons. To accomplish this notice provision, the division
may require the petitioner to serve the notice on all persons to whom notice is
required by any provision of law, and provide a written statement to the agency
attesting that notice has been provided.
185—19.8(123) Hearing procedures. The
provisions of Iowa Code sections 17A.10 to 17A.18A regarding contested case
hearings shall apply to any petition for a waiver of a rule filed within a
contested case and shall otherwise apply to division proceedings for a waiver
only when the division so provides by rule or order or is required to do so by
statute.
185—19.9(123) Ruling. An order granting or
denying a waiver shall be in writing and shall contain a reference to the
particular person and rule or portion thereof to which the order pertains, a
statement of the relevant facts and reasons upon which the action is based, and
a description of the precise scope and operative period of the waiver if one is
issued.
19.9(1) Conditions. The division may condition the
granting of the waiver on such reasonable conditions as appropriate to achieve
the objectives of the particular rule in question through alternative
means.
19.9(2) Time for ruling. The division shall grant or
deny a petition for a waiver as soon as practicable but, in any event, shall do
so within 120 days of its receipt, unless the petitioner agrees to a later date.
However, if a petition is filed in a contested case, the division shall grant or
deny the petition no later than the time at which the final decision in that
contested case is issued.
19.9(3) When deemed denied. Failure of the division
to grant or deny a petition within the required time period shall be deemed a
denial of that petition by the division.
19.9(4) Service of order. Within seven days of its
issuance, any order issued under this chapter shall be transmitted to the
petitioner or the person to whom the order pertains, and to any other person
entitled to such notice by any provision of law.
185—19.10(123) Public availability. Subject to
the provisions of Iowa Code section 17A.3(1)“e,” the division shall
maintain a record of all orders granting and denying waivers under this chapter.
All final rulings in response to requests for waivers shall be indexed and
available to members of the public at the division office.
185—19.11(123) Voiding or cancellation. A
waiver is void if the material facts upon which the request is based are not
true or if material facts have been withheld. The division may at any time
cancel a waiver upon appropriate notice and hearing if the division
finds:
1. The facts as stated in the request are not true.
2. Material facts have been withheld.
3. The alternative means of compliance provided in the waiver
have failed to achieve the objectives of the statute.
4. The requester has failed to comply with the conditions of
the order.
185—19.12(123) Violations. Violation of
conditions in the waiver approval is the equivalent of violation of the
particular rule for which the waiver is granted and is subject to the same
remedies or penalties.
185—19.13(123) Defense. After the division
issues an order granting a waiver, the order is a defense within its terms and
the specific facts indicated therein for the person to whom the order pertains
in any proceeding in which the rule in question is sought to be invoked. The
order shall only be effective to the person to whom it is issued.
185—19.14(123) Appeals. Any request for an
appeal from a decision granting or denying a waiver shall be in accordance with
the procedures provided in Iowa Code chapter 17A and the division’s rules.
An appeal shall be taken within 30 days of the issuance of the ruling in
response to the request unless a contrary time is provided by rule or
statute.
These rules are intended to implement Iowa Code chapter
123.
ARC 9632A
EMERGENCY MANAGEMENT
DIVISION[605]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code sections 17A.3 and
34A.7A, the Emergency Management Division proposes to amend Chapter 10,
“Enhanced 911 Telephone Systems,” Iowa Administrative
Code.
The amendments reflect the formal adoption of the Wireless
Enhanced 911 Implementation and Operation Plan, which is required by Iowa Code
section 34A.7A and rule 605—10.7(34A).
Consideration will be given to all written suggestions or
comments on the proposed amendments received on or before February 15, 2000.
Such written materials should be sent to the E911 Program Manager, Emergency
Management Division, Hoover State Office Building, Des Moines, Iowa 50319, or
fax (515)281–7539.
Also, there will be a public hearing on February 15, 2000, at
10 a.m. in the Emergency Management Conference Room, Level A, Hoover State
Office Building, 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
rule.
Any persons who intend to attend the public hearing and have
special requirements such as hearing or mobility impairments should advise the
Emergency Management Division of specific needs.
These amendments are intended to implement Iowa Code chapter
34A.
These amendments were also Adopted and Filed Emergency and are
published herein as ARC 9633A. The content of that submission is
incorporated by reference.
ARC 9612A
HUMAN SERVICES
DEPARTMENT[441]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code section 217.6, the
Department of Human Services proposes to amend Chapter 53, “Rent Subsidy
Program,” appearing in the Iowa Administrative Code.
The rent subsidy program is designed to provide rentassistance
to persons who participate in a home– andcommunity–based service
(HCBS) waiver program and who were discharged from a medical institution in
which they have resided, at risk of institutional placement, or able to leave a
medical institution by use of services provided under an HCBS waiver upon
turning 18 years of age during the last year of their institutional
stay.
An eligible person may receive assistance in meeting rental
expense and, in the initial two months of eligibility, in purchasing necessary
household furnishings and supplies.
These amendments revise policy governing the rent subsidy
program as follows:
• The basis of the maximum
rental assistance payment is increased from 100 percent to 110 percent of the
maximum prevailing fair market rent under guidelines of the applicable United
States Department of Housing and Urban Development (HUD) low–rent housing
program in the area where the person’s residence is located, less 30
percent of the gross income of the individual consumer.
The Department of Housing and Urban Development (HUD)
published interim regulations in the May 14, 1999, Federal Register at 24 CFR
982.503(b) and final regulations in the October 21, 1999, Federal Register
allowing public housing authorities to establish the payment standard amount for
a unit size at any level between 90 percent and 110 percent of the published
Fair Market Rental for that unit size. The Department has decided to use the
maximum guideline established by HUD to establish the amount of the rental
assistance.
This change will, in most cases, result in increased monthly
payments to participants. This increase is the same as would be experienced by
participants in the federal rental assistance program, and makes the
Department’s program consistent with the federal program payment
structure.
• Time–limited policy
regarding eligibility criteria that is no longer in effect is deleted.
• The reference to
one–bedroom homes is clarified.
• Statutory references are
updated.
These amendments do not provide for waivers in specified
situations because they only provide additional benefits, delete an outdated
provision, clarify language, and update statutory references.
Consideration will be given to all written data, views, and
arguments thereto received by the Office of Policy Analysis, Department of Human
Services, Hoover State Office Building, Des Moines, Iowa 50319–0114, on or
before February 16, 2000.
These amendments are intended to implement Iowa Code section
217.6 and 1999 Iowa Acts, chapter 203, section 11, subsection 3.
The following amendments are proposed.
ITEM 1. Amend the parenthetical
implementation following each rule in 441—Chapter 53 as
follows:
(77GA,ch1218 78GA,ch203)
ITEM 2. Amend subrule 53.2(2) as
follows:
53.2(2) Discharged from a medical institution. Except
as provided in subrules 53.2(4) and 53.2(5), the person shall have been
discharged from a medical institution on or after July 1, 1995, and immediately
prior to receiving HCBS services. For a period of 60 days after April
1, 1999, persons who were discharged from a medical institution immediately
prior to entering an HCBS program between July 1, 1995, and June 30, 1996, shall
receive first consideration for eligibility and participation in this program if
they demonstrate a need for rental assistance. These persons shall not replace
anyone who is actively participating in this program at the time of their
application. During this 60–day period, applications may be submitted by
anyone, although first consideration will be given to the persons described
above, whose applications will be acted upon in the order they are received. At
the end of the 60–day period, all applications received during that time
from persons not described above shall be considered in the chronological order
that they were received and, if applicable, participation in the program shall
be approved retroactive to the date that would have been allowed had an
application been processed immediately on receipt.
ITEM 3. Amend subrule 53.3(2) as
follows:
53.3(2) Date of application. The date of the
application shall be the date the application, including written verification of
income and written verification of application to other rental assistance
programs, is received by the division of mental health and developmental
disabilities. Applications received through June 30, 1999, on behalf of
persons who would have met all of the qualifying criteria between July 1, 1998,
and their date of application will be assessed for payment consideration
retroactive to July 1, 1998, or the date between July 1, 1998, and the date of
application on which the applicant would have met all eligibility
criteria.
ITEM 4. Amend subrule 53.4(2) as
follows:
53.4(2) Maximum monthly payment for rent. Assistance
for rent shall be equal to the rent paid, not to exceed 110 percent of
the maximum prevailing fair market rent under guidelines of the applicable
United States Department of Housing and Urban Development (HUD) low–rent
housing program in the area where the person’s residence is located, less
30 percent of the gross income of the individual consumer. The fair market rent
used shall be that for a one–bedroom home or a proportionate
share of rental costs in living units containing more than one
bedroom.
ITEM 5. Amend 441—Chapter
53, implementation clause, as follows:
These rules are intended to implement Iowa Code section 217.6
and 1998 1999 Iowa Acts, chapter 1218
203, section 11, subsection 3.
ARC 9613A
HUMAN SERVICES
DEPARTMENT[441]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code section 249A.4, the
Department of Human Services proposes to amend Chapter 78, “Amount,
Duration and Scope of Medical and Remedial Services,” appearing in the
Iowa Administrative Code.
This amendment expands the coverage of area education agency
services under Medicaid to include social work, nursing, and vision services.
This change was requested by the area education agencies.
This change will not impact the Medicaid budget as the area
education agencies provide the state match for these services. Federal funding
is available for 75 percent of the cost of the services billed.
This amendment does not provide for waivers in specified
situations because the amendment only provides additional benefits.
Consideration will be given to all written data, views, and
arguments thereto received by the Office of Policy Analysis, Department of Human
Services, Hoover State Office Building, Des Moines, Iowa 50319–0114, on or
before February 16, 2000.
This amendment is intended to implement Iowa Code section
249A.4.
The following amendment is proposed.
Amend rule 441—78.32(249A) as follows:
441—78.32(249A) Area education agencies.
Payment will be made for physical therapy, occupational therapy, psychological
evaluations and counseling, psychotherapy,
speech–language therapy, and audiological, nursing, and
vision services provided by an area education agency (AEA). These services
shall be provided by personnel who meet standards as set forth in department of
education rules 281— 41.8(256B,34CFR300) and to
281—41.9(256B,273, 34CFR300) 41.10(256B) to the
extent that their certification or license allows them to provide these
services. Services shall be provided directly by the AEA or through contractual
arrangement with the AEA.
This rule is intended to implement Iowa Code section
249A.4.
ARC 9614A
HUMAN SERVICES
DEPARTMENT[441]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code section 234.6, the
Department of Human Services proposes to amend Chapter 114, “Licensing and
Regulation of All Group Living Foster Care Facilities for Children,” and
Chapter 185, “Rehabilitative Treatment Services,” appearing in the
Iowa Administrative Code.
These amendments revise the placement criteria in Chapter 185
for children to be served in a highly structured residential facility and
establish criteria for readmission to the program. An exception process is also
added for children who do not meet the placement criteria. The definition of
“highly structured juvenile program” in Chapter 114 is revised to
remove duplicative policy.
Highly structured juvenile programs, more commonly known as
boot camps, are programs lasting 90 days, which have a high degree of structure
that stresses discipline, physical activity, and education.
Current policy requires that young men admitted to highly
structured group foster care be 15 to 17 years old; be adjudicated delinquent on
a charge that is at least an aggravated misdemeanor, but is not a forcible
felony; be unable to live in a family situation due to severe social, emotional,
and behavioral disabilities; and not be entering the program within 60 days of
another residential placement.
Young men who do not meet these criteria enter the program by
a Director’s exception to policy as set forth at rule 441—1.8(217).
There has been a substantial volume of admission by exceptions, particularly for
boys who have been adjudicated delinquent for crimes less serious than
aggravated misdemeanors.
These amendments maintain the age criteria. A requirement
that the adjudicated crime be at least a serious misdemeanor has been
substituted for the current requirement ofan aggravated misdemeanor. In
addition, the prohibition against entering the program within 60 days of another
residential setting has been deleted and a requirement is added that youth not
be able to benefit from further community–based services at the time of
placement, but be able to successfully return to the community following
intensive short–term residential treatment.
These amendments also change the process by which exceptions
are granted. Young men who meet the criteria for admission will be deemed part
of the target population for admission. Candidates for admission who are not
part of the target population may be admitted with the approval of a Department
regional administrator or designee. A regional administrator or designee may
delegate this authority to the chief juvenile court officers or designees. The
Department and juvenile court services will be required to keep data on the
children placed who lack one or more of the target population
characteristics.
The proposed target populations better identify the categories
of young men most likely to benefit from the rigor and structure of these
programs. The new process for exceptions to policy will have two benefits: it
will translate into policy current best practice in providing this type of
residential program to those most likely to benefit from it, and it will save
caseworker time in processing exceptions.
The Department has also had several requests for exceptions to
policy to allow readmission to the programs. These amendments provide that
program participants may be readmitted to the program for an additional 30, 60,
or 90 days. A readmission shall be decided upon and processed in the same
manner as the original admission, using the same criteria. A readmission should
be a rare occurrence, used only when troublesome behaviors, diagnoses or
problems arise late in the original placement, and more time in the program will
benefit the child.
The Department and juvenile court services are required to
keep data on the children placed who lack one or more of the target population
characteristics and on the children who are readmitted to a program.
These amendments do provide a process for waiver of the highly
structured program admission criteria by Department regional administrators or
their designees or, if so delegated, by chief juvenile court officers or their
designees. Individuals may request a waiver of other criteria under the
Department’s general rule on exceptions at rule
441—1.8(217).
Consideration will be given to all written data, views, and
arguments thereto received by the Bureau of Policy Analysis, Department of Human
Services, Hoover State Office Building, Des Moines, Iowa 50319–0114, on or
before February 16, 2000.
These amendments are intended to implement Iowa Code sections
234.38 and 237.3.
The following amendments are proposed.
ITEM 1. Amend rule
441—114.2(237), definition of “Highly structured juvenile
program,” as follows:
“Highly structured juvenile program” means a
short–term treatment program for adjudicated delinquent
youth, aged 15 to 17, who are unable to live in a family situation due to severe
social, emotional, and behavioral disabilities, who have not experienced a
residential placement in the last 60 days, have a prior adjudication of
delinquency, have committed a public offense that is an aggravated misdemeanor
or above, and have not committed a forcible felony. These programs
have lasting 90 days and having a high degree of structure that
stresses discipline, physical activity, and education, and are
short–term placements with a length of stay of 90 days. Program
participants are assembled in cohorts (groups of youth adjudicated delinquent as
to the criteria listed above) which are managed by the juvenile court. Each
cohort is a number that is one–third of the program, with a cohort
scheduled to finish the 90–day program every 30 days. Discharge planning
must be started within the first 30 calendar days of placement. Specialized
behavior management techniques are used several times per day. In addition,
youth receiving the highly structured juvenile program shall require and receive
treatment several times daily to enhance their social skills. In addition to
the intensive programming and structure, the youth are provided 24–hour
awake supervision.
These programs must be licensed as either communityresidential
facilities under this chapter or as comprehensiveresidential facilities under
441—Chapter 115 and certifiedto provide rehabilitative treatment services
under 441— Chapter 185. Programs shall have the ability to use a
physically secure setting dependent upon the level of the license.
ITEM 2. Amend subrule 185.83(4) as
follows:
185.83(4) Highly structured juvenile program. A
highly structured juvenile program provides treatment in a facility
licensed under 441—Chapter 114 or 115 for adjudicated delinquent youth
from the ages of 15 to 17 years who are unable to live in a family situation due
to severe social, emotional and behavioral disabilities and who have not
experienced a residential placement in the last 60 days must meet
the following requirements for licensing, admissions, readmission and discharge,
and program and services. The youth require a high degree of
supervision, and a structure that stresses discipline, physical activity,
education, and social skill development due to their aggressive behavior which
includes a prior adjudication of delinquency and commitment of a public offense
that is an aggravated misdemeanor or above, but not a forcible
felony.
a. Licensing. Facilities shall be licensed under
441— Chapter 114 or 115.
b. Admission criteria. Characteristics of the target
population to be served by this program include young men who:
(1) Are aged 15, 16, or 17.
(2) Have been adjudicated delinquent for a public offense
that is a serious misdemeanor or above, but is not a forcible
felony.
(3) Are not able to benefit further from
community–based services at the time of placement, but would be able to
successfully return to the community following intensive short–term
residential treatment.
Regional administrators for the department, in consultation
with juvenile court services, shall have authority to place youth that lack one
or more target population characteristics on a case–by–case basis.
A regional administrator or designee may delegate this authority to the chief
juvenile court officers or their designees. The department and juvenile court
services shall keep data on the children placed who lack one or more of the
target population characteristics.
c. Readmission and discharge. Program participants may be
readmitted to the program for an additional 30, 60, or 90 days. A readmission
shall be decided upon and processed in the same manner as the original
admission, using the same criteria. A readmission should be a rare occurrence,
used only when troublesome behaviors, diagnoses or problems arise late in the
original placement, and more time in the program will benefit the child. The
department and juvenile court services shall keep data on the children
readmitted to the program.
There are no temporary discharges from the highly
structured program to detention or other placement for discipline
purposes.
d. Program and services. This program is a
short–term treatment program with a length of stay of 90 days. Program
participants are assembled in cohorts (groups of youth adjudicated
delinquent as to the criteria listed above that advance through the
program together) which are managed by the juvenile court.
Each cohort is a number that is one–third of the program, with a cohort
scheduled to finish the 90–day program in 30 days. Discharge planning
must be started within the first 30 calendar days of placement.
Specialized behavior management techniques are used
several times per day. In addition, youth receiving the highly structured
juvenile program shall require and receive treatment several times daily to
enhance their social skills. In addition to the intensive programming and
structure, the youth are provided 24–hour awake
supervision.
a. (1) Youth in the highly
structured juvenile program shall receive the following
services: restorative living skills development as needed and social
skill development several times per day.
(2) One hour of therapy and counseling services shall
be provided every week to each youth.
b. (3) The prime programming time
hours and staff–to–client ratio shall meet the treatment and
supervision needs of the youth served as specified in
185.10(8)“c”(4).
c. (4) The payment for the daily rate
shall be calculated based on a 30–day month. If, however, the department
is able to provide payment based on the actual number of days in a month, rates
shall be adjusted accordingly.
d. (5) The unit of service for highly
structured juvenile residential treatment shall be one day.
e. (6) Services shall be provided on a
face–to–face basis with the child.
f. (7) Duration shall not exceed three
calendar months.
(8) Youth shall have supervision 24 hours a day by awake
staff.
ARC 9615A
HUMAN SERVICES
DEPARTMENT[441]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code section 234.6, the
Department of Human Services proposes to amend Chapter 152,
“Contracting,” appearing in the Iowa Administrative Code.
These amendments allow the effective date of a rehabilitative
treatment and supportive services contract to be the day following the final
signing by the Department Director or designee unless a later effective date is
agreed upon by the provider and the Department. Current policy requires the
contract to be effective the first day of the month following
signature.
The Department is seeking to shorten time frames for approving
contracts in order to facilitate access to services. This change may reduce the
time from final signature of a contract by the Director to the effective date by
up to 30 days.
These amendments do not provide for waivers in specified
situations because providers may request a waiver of the contract effective date
under the Department’s general rule on exceptions at rule
441—1.8(217).
Consideration will be given to all written data, views, and
arguments thereto received by the Office of Policy Analysis, Department of Human
Services, Hoover State Office Building, Des Moines, Iowa 50319–0114, on or
before February 16, 2000.
These amendments are intended to implement Iowa Code section
234.6.
The following amendments are proposed.
ITEM 1. Amend rule 441—152.8(234)
as follows:
441—152.8(234) Term of contract. The term of
the contract shall be for not more than two years, effective the
first day of the month following the signature
of the director of the department or the director’s designee, unless
the provider and department agree to a later specified date.
ITEM 2. Amend subrule 152.22(6) as
follows:
152.22(6) Contract effective date. When the
agreed–upon contract conditions have been met, the effective date of
the a new contract, a renewed contract or an
amendment to add a new service code to the contract is the
first day of an agreed–upon month
following signature of the director of the department or the director’s
designee, unless the provider and the department agree to a later specified
date. A contract can only be effective if signed by all parties as required
in subrule 152.22(4).
ARC 9625A
INSPECTIONS AND APPEALS
DEPARTMENT[481]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code chapter 10A and
Executive Order Number 11, the Department of Inspections and Appeals hereby
gives Notice of Intended Action to adopt Chapter 6, “Uniform Waiver and
Variance Rules,” Iowa Administrative Code.
The rules in Chapter 6 describe the procedures for applying
for, issuing or denying waivers and variances from Department rules. The
purpose of these rules is to comply with Executive Order Number 11, which
requires state agencies to adopt a uniform waiver rule.
Public comments concerning the proposed rules will be accepted
until 4:30 p.m. on February 15, 2000. Interested persons may submit written
comments by contactingJennifer Komos, Department of Inspections and Appeals,
Second Floor, Lucas State Office Building, 321 East 12th Street, Des Moines,
Iowa 50319, or fax to (515)242–6863. E–mail may be sent to
jkomos@dia.state.ia.us.
These rules are intended to implement Executive Order Number
11.
The following new chapter is proposed.
CHAPTER 6
UNIFORM WAIVER AND VARIANCE RULES
481—6.1(ExecOrd11) Applicability. This
chapter outlines a uniform process for the granting of waivers or variances from
rules adopted by the department. The intent of this chapter is to allow persons
to seek exceptions to the application of rules issued by the
department.
481—6.2(ExecOrd11) Definitions.
“Attached units” means units attached to the
department and includes the employment appeal board, hospital licensing board,
Iowa citizens foster care review board, racing and gaming commission and state
public defender’s office.
“Department” means the department of inspections
and appeals, authorized by Iowa Code chapter 10A, which is comprised of the
administrative hearings division, audits division, health facilities division,
inspections division and investigations division. Pursuant to Iowa Code section
7E.2(5), five attached units are included in the department.
“Director” means the director of the department of
inspections and appeals or the director’s designee.
“Director/board” means the director, board,
commission or state public defender depending on which one has
thedecision–making authority pursuant to Iowa Code chapter 10A or
7E.
“Person” means an individual, corporation, limited
liability company, government or governmental subdivision or association, or any
legal entity.
481—6.3(ExecOrd11) Interpretive rules. This
uniform waiver and variance rule shall not apply to rules that merely define the
meaning of a statute or other provisions of law or precedent if the department
does not possess delegated authority to bind the courts to any extent with its
definition.
481—6.4(ExecOrd11) Compliance with statute. No
waiver or variance may be granted from a requirement which is imposed by
statute. Any waiver or variance must be consistent with statute.
481—6.5(ExecOrd11) Criteria for waiver or variance.
The director/board may issue an order, in response to a completed petition
or on the department’s own motion, granting a waiver or variance from a
rule adopted by the department, in whole or in part, as applied to the
circumstances of a specified person if the director/board finds that:
1. Application of the rule to the person at issue would result
in hardship or injustice to that person; and
2. Waiver or variance on the basis of the particular
circumstances relative to that specified person would be consistent with the
public interest; and
3. Waiver or variance in the specific case would not prejudice
the substantial legal rights of any person.
In determining whether waiver or variance would be consistent
with the public interest under “2,” the director/board shall
consider whether, if the waiver or variance is granted, the public health and
safety will be protected by other means that are substantially equivalent to
full compliance with the rule.
6.5(1) Director/board discretion. The
decision on whether the circumstances justify the granting of a waiver or
variance shall be made at the discretion of the director upon consideration of
all relevant factors, except for the below–listed programs, for which the
applicable board, commission or state public defender shall make the decision,
upon consideration of all relevant factors:
1. Employment Appeal Board, 486—Chapter 1.
2. Hospital Licensing Board, 481—Chapter 51.
3. Iowa Citizens Foster Care Review Board, 489— Chapter
1.
4. Racing and Gaming Commission, 491—Chapter
1.
5. State Public Defender’s Office, 493—Chapter
1.
6.5(2) Mandatory waivers or variances. In response to
the timely filing of a completed petition requesting a waiver or variance, the
director/board shall grant a waiver or variance from a rule, in whole or in
part, as applied to the particular circumstances of a specified person, if the
director/board finds that the application of all or a portion thereof to the
circumstances of that specified person would not, to any extent, advance or
serve any of the purposes of the rule.
6.5(3) Burden of persuasion. The petitioner shall
assume the burden of persuasion when a petition is filed for a waiver or
variance from a department rule.
6.5(4) Special waiver or variance rules not precluded.
This uniform waiver and variance rule shall not preclude the department from
granting waivers or variances in other contexts or on the basis of other
standards if a statute or other department rule authorizes the department to do
so, and the department deems it appropriate to do so.
6.5(5) Administrative deadlines. When the rule from
which a waiver or variance is sought establishes administrative deadlines, the
director/board shall balance the special individual circumstances of the
petitioner with the overall goal of uniform treatment of all persons similarly
situated.
481—6.6(ExecOrd11) Filing of petition. A
petition for a waiver or variance must be submitted in writing to the Department
of Inspections and Appeals, Office of the Director, Lucas State Office Building,
321 East 12th Street, Des Moines, Iowa 50319. If the petition relates to a
pending contested case, the petition shall also be filed in the contested case
proceeding.
481—6.7(ExecOrd11) Content of petition. A
petition for waiver or variance shall include the following information where
applicable and known to the requester:
1. The name, address, and telephone number of the person or
entity for whom a waiver or variance is being requested, and the case number of
any related contested case.
2. A description and citation of the specific rule from which
a waiver or variance is requested.
3. The specific waiver or variance requested, including the
precise scope and operative period that the waiver or variance will
extend.
4. The relevant facts that the petitioner believes would
justify a waiver or variance. This statement shall include a signed statement
from the petitioner attesting to the accuracy of the facts provided in the
petition, and a statement of reasons that the petitioner believes will justify a
waiver or variance.
5. A history of any prior contacts between the department and
the petitioner relating to the regulated activity, license, appeal, hearing,
audit, investigation, inspection, representation or other assigned function of
the department that would be affected by the proposed waiver or variance,
including a description of each regulated activity, license, appeal, hearing,
audit, investigation, inspection, representation or other assigned function of
the department, any notices of violation, contested case hearings, or
investigative reports relating to the regulated activity, license, appeal,
hearing, audit, investigation, inspection, representation or other assigned
function of the department within the last five years.
6. Any information known to the requester regarding the
department’s treatment of similar cases.
7. The name, address, and telephone number of any public
agency or political subdivision which also regulates the activity in question,
or which might be affected by the grant of a waiver or variance.
8. The name, address, and telephone number of any person or
entity that would be adversely affected by the grant of a petition.
9. The name, address, and telephone number of any person with
knowledge of the relevant facts relating to the proposed waiver or
variance.
10. Signed releases of information authorizing persons with
knowledge regarding the request to furnish the department with information
relevant to the waiver or variance.
481—6.8(ExecOrd11) Additional information.
Prior to issuing an order granting or denying a waiver or variance, the
department may request additional information from the petitioner relative to
the petition and surrounding circumstances. If the petition was not filed in a
contested case, the department may, on its own motion or at the
petitioner’s request, schedule a telephonic or in–person meeting
between the petitioner and the department or department’s
designee.
481—6.9(ExecOrd11) Notice. The department shall
acknowledge a petition upon receipt. The department shall ensure that notice of
the pendency of the petition and a concise summary of its contents have been
provided to all persons to whom notice is required by any provision of law,
within 30 days of the receipt of the petition. In addition, the department may
give notice to other persons. To accomplish this notice provision, the
department may require the petitioner to serve the notice on all persons to whom
notice is required by any provision of law, and provide a written statement to
the department attesting that notice has been provided.
481—6.10(ExecOrd11) Hearing procedures. The
provisions of Iowa Code sections 17A.10 to 17A.18A regarding contested case
hearings shall apply to any petition for a waiver or variance of rule filed
within a contested case, and shall otherwise apply to agency proceedings for a
waiver or variance only when the department so provides by rule or order or is
required to do so by statute.
481—6.11(ExecOrd11) Ruling. An order granting
or denying a waiver or variance shall be in writing and shall contain a
reference to the particular person and rule or portion thereof to which the
order pertains, a statement of the relevant facts and reasons upon which the
action is based, and a description of the precise scope and operative period of
the waiver if one is issued.
6.11(1) Conditions. The director/board may condition
the grant of the waiver or variance on such reasonable conditions as appropriate
to achieve the objectives of the particular rule in question through alternative
means.
6.11(2) Time for ruling. The director/board shall
grant or deny a petition for a waiver or variance as soon as practicable but, in
any event, shall do so within 120 days of its receipt, unless the petitioner
agrees to a later date. However, if a petition is filed in a contested case,
the director/board has the discretion to wait until the contested case is
resolved before entering an order on the petition for waiver or
variance.
6.11(3) When deemed denied. Failure of the
director/board to grant or deny a petition within the required time period shall
be deemed a denial of that petition by the director/board.
6.11(4) Service of order. Within seven days of its
issuance, any order issued under this uniform rule shall be transmitted to the
petitioner or the person to whom the order pertains, and to any other person
entitled to such notice by any provision of law.
481—6.12(ExecOrd11) Public availability.
Subject to the provisions of Iowa Code section 17A.3(1e), the department shall
maintain a record of all orders granting and denying waivers and variances under
this uniform rule. All final rulings in response to requests for waivers or
variances shall be indexed and available to members of the public at the
director’s office.
481—6.13(ExecOrd11) Voiding or cancellation. A
waiver or variance is void if the material facts upon which the request is based
are not true or if material facts have been withheld. The director/board may at
any time cancel a waiver or variance upon appropriate notice and hearing if the
director/board finds that the facts as stated in the request are not true,
material facts have been withheld, the alternative means of compliance provided
in the waiver or variance have failed to achieve the objectives of the statute,
or the requester has failed to comply with the conditions of the
order.
481—6.14(ExecOrd11) Violations. Violation of
conditions in the waiver or variance approval is the equivalent of violation of
the particular rule for which the waiver or variance is granted and is subject
to the same remedies or penalties.
481—6.15(ExecOrd11) Defense. After the
director/board issues an order granting a waiver or variance, the order is a
defense within its terms and the specific facts indicated therein for the person
to whom the order pertains in any proceeding in which the rule in question is
sought to be invoked.
481—6.16(ExecOrd11) Appeals. Any request for an
appeal from a decision granting or denying a waiver or variance shall be in
accordance with the procedures provided in Iowa Code chapter 17A and department
rules. An appeal shall be taken within 30 days of the issuance of the ruling in
response to the request unless a contrary time is provided by rule or
statute.
481—6.17(ExecOrd11) Sample petition for waiver or
variance.
BEFORE THE DEPARTMENT OF INSPECTIONS AND
APPEALS
|
Petition by (insert name of petitioner) for the waiver of
(insert rule citation) relating to (insert the subject matter).
|
}
|
PETITION FOR WAIVER
|
Include the following information in the petition for waiver
where applicable and known:
1. Provide the petitioner’s (the person that is asking
for the waiver or variance) name, address and telephone number.
2. Describe and cite the specific rule from which a waiver or
variance is requested.
3. Describe the specific waiver or variance requested, include
the exact scope and time period that the waiver or variance will
extend.
4. Explain the important facts that the petitioner believes
justify the waiver or variance. Include in your explanation (1) why application
of the rule would result in hardship or injustice to the petitioner; and (2) why
granting a waiver or variance to the petitioner would be consistent with the
public interest; and (3) why granting the waiver or variance would not prejudice
the substantial legal rights of any person.
5. Provide history of prior contacts between the department
and the petitioner relating to regulated activity, license, audit,
investigation, inspection or representation that would be affected by the waiver
or variance. In that history, include a description of each affected regulated
activity, license, appeal, hearing, audit, investigation, inspection,
representation or other assigned function of the department, any notices of
violation, contested case hearings, or investigative reports relating to the
regulated activity, license, appeal, hearing, audit, investigation, inspection,
representation or other assigned function of the department within the last five
years.
6. Provide information known to the petitioner regarding the
department’s treatment of similar cases.
7. Provide the name, address and telephone number of any
public agency or political subdivision which also regulates the activity in
question, or which might be affected by the grant of a waiver or
variance.
8. Provide the name, address and telephone number of any
person or entity that would be adversely affected or disadvantaged by the grant
of the waiver or variance.
9. Provide signed releases of information authorizing persons
with knowledge regarding the request to furnish the department with information
relevant to the waiver or variance.
I hereby attest to the accuracy and truthfulness of the above
information.
Petitioner’s signature Date
These rules are intended to implement Executive Order Number
11.
ARC 9611A
INSPECTIONS AND APPEALS
DEPARTMENT[481]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code section 10A.104(5), the
Department of Inspections and Appeals proposes to amend Chapter 71,
“Overpayment Recovery Unit,” Iowa Administrative Code.
The proposed amendment brings rules into conformity with the
DHS rules by deleting language that permitted unemployment compensation as one
of the methods used for the collection of food stamp overpayments.
The proposed amendment modifies an existing rule and will be
of benefit to the recipients of unemployment compensation. Therefore, it is the
opinion of the Department that a waiver is not necessary.
Interested persons may make written comments or
sug–gestions on the proposed amendment on or before February 15, 2000.
Written materials should be addressed to the Director, Department of Inspections
and Appeals, Lucas State Office Building, East 12th and Grand Avenue, Des
Moines, Iowa 50319–0083, or faxed to (515)242–6863. E–mail
may be sent to csmith@dia.state.ia.us.
This amendment is intended to implement Iowa Code section
10A.402(5).
The following amendment is proposed.
Amend subrule 71.6(2) as follows:
71.6(2) For food stamp overpayments. In addition to
the actions in subrule 71.6(1), the following may be used for the collection of
food stamp overpayments.
a. Federal income tax refund offset in accordance with Iowa
Administrative Code rule 441—11.5(234).
b. Federal payments (i.e., wages) withholding in accordance
with Iowa Administrative Code rule 441—11.5(234).
c. Unemployment compensation withholding in accordance
with Iowa Administrative Code rule 441—11.5(234).
The recovery unit may use one or more of the above actions
listed for any overpayment that has occurred.
ARC 9631A
LABOR SERVICES
DIVISION[875]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code chapter 17A and section
91.6, the Labor Commissioner hereby gives Notice of Intended Action to amend
Chapter 1, “Description of Organization and Procedures before the
Division,” Iowa Administrative Code.
These rules establish procedures for waiver of Division rules
and are being adopted to implement Executive Order Number 11.
If requested no later than February 11, 2000, by 25 interested
persons, a governmental subdivision, the Administrative Rules Review Committee,
an agency, or an association having not less than 25 members, a public hearing
will be held on February 15, 2000, at 1:30 p.m. at 1000 East Grand Avenue, Des
Moines, Iowa. Interested persons will be given the opportunity to make oral
statements and file documents concerning the proposed rules. The facility for
the oral presentations is accessible to and functional for persons with physical
disabilities. Persons who have special requirements should call
(515)242–5869 in advance to arrange access or other needed
services.
Written data, views, or arguments to be considered in adoption
shall be submitted by interested persons no later than February 15, 2000, to
Division of Labor Services, 1000 East Grand Avenue, Des Moines, Iowa
50319–0209.
The Division of Labor Services will issue a regulatory
analysis as provided by 1998 Iowa Acts, chapter 1202, section 10, if a written
request is submitted no later than February 28, 2000, to Division of Labor
Services, 1000 East Grand Avenue, Des Moines, Iowa 50319. The request may be
made by the Administrative Rules Review Committee, the Administrative Rules
Coordinator, at least 25 persons who each qualify as a small business, or an
organization representing at least 25 small businesses. The organization shall
list the names, addresses and telephone numbers of not less than 25 small
businesses it represents.
These rules will not necessitate combined expenditures
exceeding $100,000 by all political subdivisions or agencies and entities that
contract with political subdivisions to provide services.
These rules are intended to implement Executive Order Number
11.
The following rules are proposed.
ITEM 1. Reserve rule
875—1.100 in Division VI.
ITEM 2. Amend 875—Chapter 1 by
adopting the following new Division VII:
DIVISION VII
WAIVERS
FROM ADMINISTRATIVE RULES
875—1.101(17A,91) Scope.
1.101(1) These rules provide general procedures for
waivers from division rules. Specific waiver or variance procedures must be
followed when applicable. No waiver may be granted from a requirement or duty
imposed by statute or when granting a waiver would cause a denial of federal
funds or be inconsistent with federal statute or regulation. Any waiver must be
consistent with statute. These waiver procedures do not apply to rules that
merely define the meaning of a statute or other provision of law unless the
division possesses delegated authority to bind the courts with its
rules.
1.101(2) Waivers of rules may be granted either upon
the division’s own motion, in response to a petition for waiver filed
within a contested case proceeding, or in response to a petition filed in the
absence of a contested case proceeding.
875—1.102(17A,91) Petitions. If the petition
for waiver relates to a pending contested case, the petition shall be filed in
the contested case proceeding. Other petitions must be submitted in writing to
Byron K. Orton, Labor Commissioner, 1000 E. Grand Avenue, Des Moines, Iowa
50319. In either case, the petition shall include the following information
where applicable:
1.102(1) The name, address, case file number or state
identification number, and telephone number of the person requesting the waiver
and the person’s representative, if any.
1.102(2) A description and citation of the specific
rule to which the petition applies.
1.102(3) The specific waiver requested, including the
precise scope and time period for the waiver.
1.102(4) The relevant facts the petitioner believes
justify a waiver.
1.102(5) A description of any prior contacts between
the division and the petitioner relating to the subject matter of the proposed
waiver, including but not limited to a list or description of division licenses,
registrations, or permits held by the petitioner, and any notices of violation,
citations, contested case hearings, or investigative reports relating to the
subject matter of the proposed waiver within the last five years.
1.102(6) The name, address, and telephone number of
any public agency or political subdivision which also regulates the activity in
question or which might be affected by the grant of a waiver.
1.102(7) Any information known to the petitioner
regarding the division’s treatment of similar cases.
1.102(8) The name, address, and telephone number of
all persons inside or outside state government who would be adversely affected
by the grant of the petition or who possess knowledge of relevant
facts.
1.102(9) A signed release of information authorizing
persons with knowledge regarding the request to furnish the division with
information pertaining to the waiver.
1.102(10) A signed statement from the petitioner
attesting to the accuracy of the facts provided in the petition.
875—1.103(17A,91) Notice and acknowledgment.
The division will acknowledge petitions upon receipt. The division shall ensure
that notice of the pendency of the petition and a concise summary of its
contents have been provided to all persons to whom notice is required by any
provision of law within 30 days of receipt of the petition. The division may
require the petitioner to serve the notice and a concise summary on all persons
to whom notice is required by any provision of law, and provide a written
statement to the division attesting that notice has been provided. Notice and a
concise summary may also be provided to others.
875—1.104(17A,91) Review. Discretion to grant
or deny a waiver petition rests with the labor commissioner or the labor
commissioner’s designee. The burden of persuasion shall be upon the
petitioner. The division may request additional information relating to the
requested waiver from the petitioner and may conduct any necessary and
appropriate investigation.
1.104(1) A waiver under these rules may be granted
upon a showing that:
a. Application of the rule to the person at issue would result
in hardship or injustice to that person;
b. Waiver of the rule in the specific circumstances would be
consistent with the public interest; and
c. Waiver of the rule in the specific circumstances would not
prejudice the substantial legal rights, health, or safety of any
person.
1.104(2) A waiver shall be granted in whole or in part
upon a finding that the application of all or a portion of a rule to the
circumstances of the petitioner would not advance or serve any of the purposes
of the rule to any extent.
875—1.105(17A,91) Ruling.
1.105(1) The division shall grant or deny all requests
as soon as practicable, but no later than 120 days from receipt without consent
of the petitioner. However, waiver petitions filed in contested cases shall be
granted or denied no later than the date of the decision in the contested case
proceeding. Failure to grant or deny a petition within the required time period
shall be deemed a denial.
1.105(2) The ruling shall be in writing and shall
include the reasons for granting or denying the petition and, if approved, the
time period during which the waiver is effective. The division may condition
the grant of a waiver on such reasonable conditions as appropriate to achieve
the objectives of the particular rule in question through alternative
means.
1.105(3) Within seven days of issuance of the ruling,
a copy shall be mailed to the petitioner or the petitioner’s
representative, and to any other person(s) entitled to such notice by any
provision of law or rule.
875—1.106(17A,91) Public availability. Subject
to the provisions of Iowa Code section 17A.3(1)“e,” orders granting
and denying waivers shall be indexed by rule and available for public
inspection.
875—1.107(17A,91) Cancellation. The division
may cancel a waiver upon appropriate notice and hearing if the facts alleged in
the petition or supplemental information provided were not true, material facts
were withheld or have changed, the alternative means of compliance provided in
the waiver have failed to achieve the objectives of the statute, the requester
has failed to comply with conditions set forth in the waiver approval, or the
rule or enabling act has been amended.
875—1.108(17A,91) Violations. Violation of
conditions in the waiver approval is the equivalent of violation of the
particular rule for which the waiver is granted and is subject to the same
remedies or penalties.
875—1.109(17A,91) Appeals. Appeal from a
decision granting or denying a waiver shall be in accordance with the procedures
provided in Iowa Code chapter 17A. An appeal shall be taken within 30 days of
the ruling. However, any appeal from a decision on a petition for waiver in a
contested case proceeding shall be in accordance with the procedures for appeal
of the contested case decision.
ARC 9618A
MEDICAL EXAMINERS
BOARD[653]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code sections 147.76 and
272C.3, the Board of Medical Examiners hereby gives Notice of Intended Action to
amend Chapter 13, “Standards of Practice and Professional Ethics,”
Iowa Administrative Code.
The Board approved proposed rule 653—13.3(147),
supervision of pharmacists who administer prescription drugs, during a meeting
held via telephone conference call on January 5, 2000.
The proposed rule permits physicians to prescribe two vaccines
(influenza and pneumococcal) to prepared pharmacists for administration to
adults via written protocol. It forbids physicians from prescribing other drugs
for administration by a pharmacist. The rule defines for the physician the
preparatory process that a pharmacist must complete to be considered prepared.
It also itemizes the elements needed in a written protocol for a physician to
prescribe these two vaccines for pharmacist administration to patients.
Finally, the rule describes the supervisory relationship between a prescribing
physician and an administering pharmacist.
Any interested person may present written comments, data,
views, and arguments on the proposed rule not later than 4 p.m. on February 15,
2000. Such written materials should be sent to Ann E. Mowery, Executive
Director, Board of Medical Examiners, 400 S.W. 8th Street, Suite C, Des Moines,
Iowa 50309–4686.
There will be a public hearing on February 15, 2000, at1 p.m.
in the Auditorium of the new State Historical Building, 600 East Locust Street,
Des Moines, Iowa, at which time persons may present their views either orally or
in writing.
This rule is intended to implement Iowa Code sections 147.76
and 272C.3.
The following rule is proposed.
Adopt the following new rule:
653—13.3(147) Supervision of pharmacists who
administer prescription drugs. A physician may prescribe influenza virus
vaccine and pneumococcal vaccine via written protocol for a prepared pharmacist
to administer to adults if the physician meets the following rules for
supervising the pharmacist. The physician may not prescribe, or delegate the
prescription of, any other prescription drugs for administration by a
pharmacist.
13.3(1) Definitions.
a. “Prepared pharmacist” means an
Iowa–licensed pharmacist who provides to the physician documentation of
successful completion of a 20–hour course on vaccine administration
provided by an ACPE–approved provider that:
(1) Requires documentation by the pharmacist of current
certification in the American Heart Association’s Basic Cardiac Life
Support for Health–Care Providers;
(2) Is an evidence–based course that includes study
material and hands–on training in techniques for administering vaccines,
requires testing with a passing score, meets current Centers for Disease Control
and Prevention training guidelines, and provides instruction and experiential
training in the following content areas:
1. Standards for immunization practices;
2. Basic immunology and vaccine protection;
3. Vaccine–preventable diseases;
4. Recommended immunization schedules;
5. Vaccine storage and management;
6. Informed consent;
7. Physiology and techniques for vaccine
administration;
8. Pre– and post–vaccine assessment and
counseling;
9. Immunization record management; and
10. Management of adverse events, including identification,
appropriate response, documentation, and reporting.
b. “Vaccine” means a specially prepared antigen
which, upon administration to a person, will result in immunity.
c. “Written protocol” means a physician’s
order for one or more patients that contains, at a minimum, the
following:
(1) A statement identifying the individual physician
authorized to prescribe drugs and responsible for the delegation of
administration of influenza virus vaccine and pneumococcal vaccine;
(2) A statement identifying the individual pharmacist
authorized to administer influenza virus vaccine and pneumococcal vaccine as
delegated by the physician;
(3) A statement that forbids the pharmacist from delegating
the administration of influenza virus vaccine and pneumococcal vaccine to anyone
other than a prepared pharmacist or a registered nurse;
(4) A statement identifying by address the location(s) at
which the pharmacist may administer influenza virus vaccine and pneumococcal
vaccine;
(5) A statement identifying the vaccines that may be
administered by the pharmacist, the dosage, and the route of
administration;
(6) A statement identifying the activities the pharmacist
shall follow in the course of administering influenza virus vaccine and
pneumococcal vaccine, including:
1. Procedures for determining if a patient is eligible to
receive the vaccine;
2. Procedures for determining the appropriate scheduling and
frequency of drug administration in accordance with applicable
guidelines;
3. Procedures for record keeping and long–term record
storage;
4. Procedures to follow in the case of life–threatening
reactions; and
5. Procedures for the pharmacist and patient to follow in case
of reactions following administration.
(7) A statement that describes how the pharmacist must report
the administration of influenza virus vaccine and pneumococcal vaccine to the
physician issuing the written protocols and the patient’s primary care
physician within 72 hours, including the content of the report. A standard
protocol may be used or the physician may develop an immunization or vaccination
protocol for an individual patient. If a standard protocol is used, the
physician shall record what deviations, if any, from the standard protocol are
ordered for an individual patient.
13.3(2) Supervision. A physician who prescribes
influenza virus vaccine or pneumococcal vaccine to a pharmacist for
administration shall adequately supervise that pharmacist. Physician
supervision shall be considered adequate if the delegating physician:
1. Ensures that the pharmacist meets the definition of a
“prepared pharmacist” in paragraph 13.3(1)“a”;
2. Provides a written protocol that is updated at least
annually;
3. Is geographically located so as to be easily accessible,
i.e., within 30 miles of the pharmacist administering influenza virus vaccine or
pneumococcal vaccine;
4. Is available through direct telecommunication for
consultation, assistance, and direction or provides physician backup to provide
these services when the physician supervisor is not available; and
5. Receives from the pharmacist a faxed, E–mailed,
voice, or voice–recorded report and any other appropriatefollow–up
on any patient with any problem or complication encountered within two hours of
the pharmacist’s becoming aware of it.
ARC 9627A
NATURAL RESOURCES
DEPARTMENT[561]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code sections
17A.3(1)“b” and 455A.4, the Director of the Department of Natural
Resources hereby gives Notice of Intended Action to adopt a new Chapter 10,
“Waivers or Variances from Administrative Rules,” Iowa
Administrative Code.
The proposed rules implement Executive Order Number 11, signed
by Governor Vilsack on September 14, 1999. The Executive Order establishes
uniform rules for waivers or variances from administrative rules. The other
rule–making agencies within the Department are or will be adopting this
chapter by reference, through concurrent or subsequent rule–making
proceedings.
Any interested persons may make written suggestions or
comments on the proposed amendment on or before February 15, 2000. Written
comments should be directed to Anne Preziosi, Department of Natural Resources,
Air Quality Bureau, 7900 Hickman, Urbandale, Iowa 50322; (515) 281–6243;
fax (515)242–5094. Requests for a public hearing regarding this rule
making must be submitted in writing to the above address by that date.
The Department has determined that the proposed rules will
have a favorable impact on small businesses within the meaning of Iowa Code
section 17A.4A(2)“b.”
The proposed amendment is intended to implement Iowa Code
chapter 17A.
The following new chapter is proposed.
Adopt the following new chapter:
CHAPTER 10
WAIVERS OR VARIANCES
FROM ADMINISTRATIVE
RULES
561—10.1(17A,455A) Applicability. This chapter
outlines a uniform process for the granting of waivers or variances from rules
adopted by the department. As used in this chapter, the term
“director” includes the director’s designee.
561—10.2(17A,455A) Authority. A waiver or
variance from rules adopted by the department may be granted in accordance with
this chapter if:
10.2(1) The department has exclusive rule–making
authority to promulgate the rule from which waiver or variance is requested or
has final decision–making authority over a contested case in which a
waiver or variance is requested; and
10.2(2) No statute or rule otherwise controls the
granting of a waiver or variance from the rule from which waiver or variance is
requested.
561—10.3(17A,455A) Interpretive rules. These
uniform waiver and variance rules shall not apply to rules that merely define
the meaning of a statute or other provisions of law or precedent if the
department does not possess delegated authority to bind the courts to any extent
with its definition.
561—10.4(17A,455A) Compliance with statute. No
waiver or variance may be granted from a requirement imposed by statute. Any
waiver or variance must be consistent with statute.
561—10.5(17A,455A) Criteria for waiver or
variance. The director may issue an order, in response to a petition or on
its own motion, granting a waiver or variance from a rule adopted by the
department, in whole or in part, as applied to the circumstances of a specified
person if the director finds that:
10.5(1) Application of the rule to the person would
result in hardship or injustice to that person;
10.5(2) Waiver or variance on the basis of the
particular circumstances of that specified person would be consistent with the
public interest; and
10.5(3) Waiver or variance in the specific case would
not prejudice the substantial legal rights of any person.
In determining whether waiver or variance would be consistent
with the public interest the director shall consider whether, if the waiver or
variance is granted, the public health and safety will be protected by other
means that are substantially equivalent to full compliance with the
rule.
561—10.6(17A,455A) Discretion. The decision
regarding whether the circumstances justify the granting of a waiver or variance
shall be made at the discretion of the director, upon consideration of all
relevant factors.
561—10.7(17A,455A) Mandatory waivers or
variances. In response to the timely filing of a completed petition
requesting a waiver or variance, the director shall, except to the extent
prohibited by statute, grant a waiver or variance from a rule, in whole or in
part, as applied to the particular circumstances of a specified person, if the
director finds that the application of all or a portion of the rule in question
to the circumstances of that specified person would not, to any extent, advance
or serve any of the purposes of the rule.
561—10.8(17A,455A) Burden of persuasion. The
petitioner shall assume the burden of persuasion when a petition is filed for a
waiver or variance from a department rule.
561—10.9(17A,455A) Special waiver or variance rules
not precluded. This chapter shall not preclude the department from granting
waivers in other contexts or on the basis of other standards if a statute or
other department rule authorizes the director to do so, and the director deems
it appropriate to do so.
561—10.10(17A,455A) Administrative deadlines.
When the rule from which a waiver or variance is sought establishes
administrative deadlines, the director shall balance the special individual
circumstances of the petitioner with the overall goal of uniform treatment of
all persons governed by the particular rule.
561—10.11(17A,455A) Filing of petition. A
petition for a waiver or variance shall be submitted in writing to the
department, as follows:
10.11(1) Contested cases. If the petition relates to
a pending contested case, the petition shall be filed in the contested case
proceeding. The director may elect not to rule on the waiver petition until the
resolution of the contested case proceeding.
10.11(2) Other. If the petition does not relate to a
pending contested case, the petition may be submitted to the director.
561—10.12(17A,455A) Contents of petition. A
petition for waiver or variance shall include the following information when
applicable and known to the petitioner:
10.12(1) The name, address, and telephone number of
the person or entity for whom a waiver or variance is being requested, and the
case number of any related contested case.
10.12(2) A description and citation of the specific
rule from which a waiver or variance is requested.
10.12(3) The specific waiver or variance requested,
including the precise scope and operative period that the waiver or variance
will extend.
10.12(4) The relevant facts that the petitioner
believes would justify a waiver or variance. This statement shall include a
signed statement from the petitioner attesting to the accuracy of the facts
provided in the petition and a statement of reasons that the petitioner believes
will justify a waiver or variance.
10.12(5) A history of any prior contacts between the
department and the petitioner for the past five years, including a description
of each affected permit held by the petitioner, and any notices of violation,
administrative orders, contested case proceedings, and lawsuits involving the
department and the petitioner.
10.12(6) Any information known to the petitioner
regarding the department’s treatment of similar cases.
10.12(7) The name, address, and telephone number of
any public agency or political subdivision of the state or federal government
which also regulates the activity in question, or which might be affected by the
grant of a waiver or variance.
10.12(8) The name, address, and telephone number of
any person or entity who would be adversely affected by the grant of a
petition.
10.12(9) The name, address, and telephone number of
any person with knowledge of relevant facts relating to the proposed waiver or
variance.
10.12(10) Signed releases of information authorizing
persons with knowledge regarding the request to furnish the department with
information relevant to the waiver or variance.
561—10.13(17A,455A) Additional information.
Prior to issuing an order granting or denying a waiver or variance, the director
may request additional information from the petitioner relative to the petition
and surrounding circumstances. If the petition was not filed in a contested
case, the director may, on the director’s own motion or at the
petitioner’s request, schedule a telephonic or in–person meeting
between the petitioner and the director.
561—10.14(17A,455A) Notice. The petitioner
shall serve by certified mail notice of the pending petition and a concise
summary of its contents upon all persons to whom notice is required by any
provision of law, within 30 days of submission of the petition. The petitioner
shall provide a written statement to the department attesting that the required
notice has been provided. The department shall acknowledge a petition upon
receipt and, in addition, the department may give notice to other
persons.
561—10.15(17A,455A) Hearing procedures. The
provisions of Iowa Code sections 17A.10 to 17A.18A regarding contested case
hearings shall apply to any petition for a waiver or variance of rule filed
within a contested case and shall otherwise apply to department proceedings for
a waiver or variance only when the department so provides by rule or order or is
required to do so by statute.
561—10.16(17A,455A) Ruling. An order granting
or denying a waiver or variance shall be in writing and shall contain a
reference to the particular person and rule or portion thereof to which the
order pertains, a statement of the relevant facts and reasons upon which the
action is based, and a description of the precise scope and operative period of
the waiver if one is issued.
561—10.17(17A,455A) Conditions. The director
may condition the grant of the waiver or variance on such reasonable conditions
as appropriate to achieve the objectives of the particular rule in question
through alternative means.
561—10.18(17A,455A) Time for ruling. The
director shall grant or deny a petition for a waiver or variance as soon as
practicable but, in any event, shall do so within 120 days of receipt of the
petition, unless the petitioner agrees to a later date. However, if a petition
is filed in a contested case, the director shall grant or deny the petition no
later than the time at which the final decision in that contested case is
issued.
561—10.19(17A,455A) When deemed denied. Failure
of the director to grant or deny a petition within the required time period
shall be deemed a denial of that petition by the department.
561—10.20(17A,455A) Service of order. Within
seven days of its issuance, any order issued under this chapter shall be
transmitted to the petitioner or the person to whom the order pertains and to
any other person entitled to such notice by any provision of law.
561—10.21(17A,455A) Public availability.
Subject to the provisions of Iowa Code section 17A.3(1)“e,” the
department shall maintain a record of all orders granting and denying waivers
and variances under this chapter. All final rulings in response to requests for
waivers or variances shall be indexed and available to members of the
public.
561—10.22(17A,455A) Voiding or cancellation. A
waiver or variance is void if the material facts upon which the request is based
are not true or if material facts have been withheld. The director may at any
time cancel a waiver or variance if the director finds that the facts as stated
in the request are not true, material facts have been withheld, the alternative
means of compliance provided in the waiver or variance have failed to achieve
the objectives of the statute, or the requester has failed to comply with the
conditions of the order.
561—10.23(17A,455A) Violations. Violation of
conditions of the waiver or variance approval is the equivalent of violation of
the particular rule for which the waiver or variance is granted and is subject
to the same remedies or penalties.
561—10.24(17A,455A) Defense. After the director
issues an order granting a waiver or variance, the order is a defense within its
terms and the specific facts indicated therein for the person to whom the order
pertains in any proceeding in which the rule in question is sought to be
invoked.
These rules are intended to implement Iowa Code chapters 17A,
21, 22, and 455A.
ARC 9626A
PERSONNEL
DEPARTMENT[581]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code sections 19A.9 and
97B.15, the Department of Personnel gives Notice of Intended Action to adopt new
Chapter 32, “Uniform Rules for Waivers and Variances,” Iowa
Administrative Code.
Proposed Chapter 32 outlines a uniform process for the
granting of waivers and variances from rules. Executive Order Number 11 directs
state rule–making authorities to adopt uniform rules regarding waivers and
variances from rules of the authority. These proposed rules are in response to
that order.
Any interested person may present written comments, data,
views, and arguments on the proposed chapter not later than February 15, 2000.
Such written comments should be sent to Michael Prey, Department of Personnel,
East 14th and Grand Avenue, Des Moines, Iowa 50319, or to Kelly Lovell, Iowa
Public Employees’ Retirement System, 600 East Court Avenue, Des Moines,
Iowa 50309. Persons who wish to present their comments orally may contact
Michael Prey at (515)281–4168 or Kelly Lovell at
(515)281–0089.
There will be a public hearing on February 15, 2000, at9 a.m.
at IPERS, 600 East Court Avenue, 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 proposed chapter.
These rules are intended to implement Iowa Code chapters 17A,
19A and 97B.
The following amendment is proposed.
Adopt the following new chapter:
CHAPTER 32
UNIFORM RULES FOR WAIVERS AND
VARIANCES
581—32.1(17A,19A,97B) Applicability. This
chapter outlines a uniform process for the granting of waivers or variances from
rules adopted by the department.
32.1(1) Department authority. A waiver or variance
from rules adopted by the department may be granted in accordance with this rule
if:
a. The department has exclusive rule–making authority to
promulgate the rule from which waiver or variance is requested or has final
decision–making authority over a contested case in which a waiver or
variance is requested; and
b. No statute or rule otherwise controls the grant of a waiver
or variance from the rule for which waiver or variance is requested.
32.1(2) Interpretive rules. This chapter shall not
apply to rules that merely define the meaning of a statute or other provisions
of law or precedent if the department does not possess delegated authority to
bind the courts to any extent with its definition.
32.1(3) Compliance with statute. No waiver or
variance may be granted from a requirement that is imposed by statute. Any
waiver or variance must be consistent with statute.
581—32.2(17A,19A,97B) Criteria for waiver or
variance. The department may issue an order granting a waiver or variance,
as applied to the circumstances of a specified person, if:
1. Application of the rule to that person would result in
hardship or injustice; and
2. Granting the waiver or variance on the basis of the
particular circumstances of that specified person would be consistent with the
public interest; and
3. Granting the waiver or variance in that case would not
prejudice the substantial legal rights of any other person.
In determining whether a waiver or variance would be
consistent with the public interest under paragraph “2,” the
department shall consider whether, if the waiver or variance is granted, the
public interest will be protected by other means that are substantially
equivalent to full compliance with the rule.
32.2(1) The department may condition the grant of a
proposed waiver or variance on such reasonable conditions as are appropriate to
achieve the objectives of the particular rule in question through alternative
means.
32.2(2) This rule shall not preclude the department
from granting waivers or variances in other contexts or on the basis of other
standards if the department deems it appropriate to do so and is not prohibited
by state or federal statute, federal regulations, this rule, or any other rule
adopted under Iowa Code chapter 17A from issuing such waivers or
variances.
32.2(3) The inadvertent granting of a waiver or
variance by the department shall not be deemed to be a waiver or variance to
which the provisions of this rule apply but, depending on the facts and
circumstances, the department may limit enforcement of the affected rule(s) on a
prospective basis.
32.2(4) The petitioner shall bear the burden of proof
when a petition for waiver or variance from a department rule is
filed.
32.2(5) When the rule from which a waiver or variance
is sought establishes administrative deadlines, the department shall balance the
special individual circumstances of the petitioner with the overall goal of
uniform treatment of all similarly situated persons.
581—32.3(17A,19A,97B) Filing of petition. Any
person may file a petition with the department requesting a waiver or variance,
in whole or in part, from a rule of the department on the ground that the
application of the rule to the particular circumstances of that person would
qualify for a waiver or variance.
A petition for a waiver or variance must be submitted in
writing to the administrative rules coordinator of the division of the
department having jurisdiction over the particular issue. For IPERS issues,
such petitions shall be directed to Administrative Rules Coordinator, Iowa
Public Employees’ Retirement System, 600 East Court Avenue, Des Moines
Iowa 50309. For all other department matters, such petitions shall be directed
to Administrative Rules Coordinator, Department of Personnel, East 14th and
Grand Avenue, Des Moines, Iowa 50319. If the request relates to a pending
contested case, the request shall also be filed in the contested case
proceeding. Waiver and variance rulings shall be made by department staff
having jurisdiction over the particular issue and having the authority to issue
final rulings on appeals regarding such issues, provided that the director shall
have final authority with respect to all waiver and variance rulings.
581—32.4(17A,19A,97B) Contents of petition. A
petition for waiver or variance does not have to be in a particular format, but
must contain the following elements.
1. The name, address, social security number, and telephone
number of the petitioner and the name, address, and telephone number of the
petitioner’s representative, if any.
2. The specific rule or rules for which a waiver or variance
is requested.
3. The precise scope and operative period of the waiver or
variance requested, including any alternative means or other condition or
modification proposed to achieve the purposes of the rule.
4. An explanation of the reasons for the waiver or variance,
including all material facts relevant to the waiver or variance in
question.
5. A description of any prior contacts between the department
and the petitioner relating to the proposed waiver or variance including, but
not limited to, a list or description of prior notices, investigative reports,
advice, negotiations, consultations or conferences, contested case rulings, and
penalties relating to the proposed waiver or variance.
6. The name, address, and telephone number of any person
inside or outside of state government who would be adversely affected by or who
possesses material information related to the waiver or variance in
question.
7. Any information known to the petitioner regarding the
department’s treatment of similar cases.
8. The name, address, and telephone number of any person with
knowledge of the relevant facts relating to the proposed waiver or
variance.
9. Any signed releases required to obtain relevant information
from persons with knowledge of such information.
581—32.5(17A,19A,97B) Additional information.
Prior to issuing an order granting or denying a petition for waiver or variance,
the department may request additional information from the petitioner relating
to the petition and surrounding circumstances. If the petition was not filed in
a contested case, the department may, on its own motion or at the
petitioner’s request, schedule a telephonic or in–person meeting
between the petitioner and department representatives.
581—32.6(17A,19A,97B) Notices. Within 30
business days after receipt of a petition for waiver or variance from a rule,
the department shall give notice of the pendency of the petition and a concise
summary of its contents to all persons to whom notice is required by any
provision of law. In addition, the department may give notice to other
persons.
581—32.7(17A,19A,97B) Intervenors. Persons who
qualify as intervenors under any provision of law may intervene in proceedings
for waiver or variance from a rule if they file timely petitions for
intervention according to department rules governing such
intervention.
581—32.8(17A,19A,97B) Hearing procedures. The
provisions of 581—Chapter 26 shall apply to proceedings under this chapter
if the petition for waiver or variance is filed in a contested case proceeding.
Prior to issuing an order granting or denying a proposed waiver or variance, the
department shall determine whether or not the facts alleged in the proposed
waiver are accurate and complete.
581—32.9(17A,19A,97B) Ruling. An order granting
or denying a proposed waiver or variance shall be in writing and shall contain a
reference to the particular person and rule or portion thereof to which the
order pertains, a statement of the relevant facts and reasons on which that
action is based, and a description of the precise scope (including any
conditions) and operative period of the waiver or variance, if one is
granted.
32.9(1) Time for ruling. The department shall grant
or deny a petition for the waiver or variance as soon as practicable but, in any
event, shall do so within 120 days of its receipt, unless petitioner agrees to a
later date or the department, specifying good cause, extends this time period
with respect to a particular petition for an additional 30 days. However, if a
petition for waiver or variance has been filed in a contested case proceeding,
the department shall grant or deny the petition no later than the time at which
the final decision in that contested case is issued.
32.9(2) When deemed denied. Failure of the department
to grant or deny a petition for waiver or variance within the required time
period shall be deemed a denial of that petition by the department.
32.9(3) Service of order. Within seven days of its
issuance, any order issued under this chapter shall be transmitted to the
petitioner or the person to whom the order pertains and to any other person
entitled to such notice by any provision of law.
581—32.10(17A,19A,97B) Defense. After an order
granting a waiver or variance is issued, the order is a defense within its terms
and the specific facts indicated therein for the person to whom the order
pertains in any proceeding in which the rule in question is sought to be
invoked.
581—32.11(17A,19A,97B) Public availability.
Subject to the provisions of Iowa Code section 17A.3(1)“e,” each
division of the department shall maintain a record of all orders granting and
denying waivers or variances under this chapter. All final rulings in response
to requests for waivers or variances shall be indexed and available to members
of the public at the offices of the applicable division of the
department.
581—32.12(17A,19A,97B) Rules from which the
department shall not grant waivers or variances. The department shall not
grant waivers or variances from the following rules, except as otherwise
indicated in the following list.
1. Rules which implement state or federal law, if the waiver
could affect the taxability of pension, tax–sheltered annuity, deferred
compensation, or health and dependent care benefits under the Internal Revenue
Code and regulations thereunder or the Iowa Code and rules adopted
thereunder;
2. Rules which set forth the formulas used to calculate IPERS
monthly retirement benefits, actuarial equivalents, dividends, amounts to be
credited to supplemental accounts of active members, refunds, death benefits,
and service purchase costs;
3. Rules which implement contribution rates set and actuarial
assumptions recommended by the Iowa public employees’ retirement
system’s actuary;
4. Rules which limit the release of confidential
information;
5. Rules which implement contracts between the department and
its vendors (except as permitted in such contracts);
6. Rules governing separations, disciplinary actions and
reductions in force under 581—Chapter 11, and grievances and appeals under
581—Chapter 12 (except as permitted by statute and applicable department
rules).
581—32.13(17A,19A,97B) Voiding or cancellation.
A waiver or variance is void if the material facts upon which the petition is
based are not true or if material facts have been withheld or omitted. The
department may at any time cancel a waiver or variance upon appropriate notice
and hearing if the department finds that the facts as stated in the request are
not true, material facts have been withheld or omitted, the alternative means of
compliance provided in the waiver have failed to achieve the objectives of the
statute, or the petitioner has failed to comply with conditions set forth in the
order.
581—32.14(17A,19A,97B) Violation of conditions.
Violations of the conditions precedent to a waiver’s or variance’s
approval shall be deemed to be violations of the particular rule for which the
waiver or variance was granted and will be subject to the same remedies or
penalties.
581—32.15(17A,19A,97B) Appeals. Appeals of the
department’s decisions regarding proposed waivers or variances shall be
filed in writing within 30 days after notice of the decision is mailed to the
petitioner.
These rules are intended to implement Iowa Code chapters 17A,
19A, and 97B.
ARC 9629A
PUBLIC HEALTH
DEPARTMENT[641]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
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”; 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”;
Chapter 42, “Minimum Certification Standards for Diagnostic Radiographers,
Nuclear Medicine Technologists, and Radiation Therapists”; Chapter 45,
“Radiation Safety Requirements for Industrial Radiographic
Operations”; and Chapter 46, “Minimum Requirements for Tanning
Facilities,” Iowa Administrative Code.
The following itemizes the proposed changes.
Item 1 changes the title of Chapter 38 to clarify that these
general provisions apply to radiation machines and radioactive
materials.
Items 2, 9, 24, 37, and 103 amend the rules to reflect current
federal codes.
Items 3, 25, 39, 40, 56, 64, and 65 move definitions from
Chapter 39 to 45 to Chapter 38 because they apply to and are used in more than
one chapter. Some of the definitions are amended or new definitions are
proposed because of agreements with the Nuclear Regulatory Commission (NRC) and
Food and Drug Administration (FDA) that require that the agency adopt certain
language.
Items 4, 38, 50, 55, 63, 75, and 100 apply language that will
allow the rules to apply to all chapters for which the agency is
responsible.
Item 5 adds fees for food sterilization and bone densitometry
which are new categories. Bone densitometry was previously included in Category
1 of the annual fee schedule. The fee for food sterilization is based on the
time required to review the approval requests and oversee testing.
Item 6 increases examination fees to allow the Bureau of
Radiological Health to recover the cost of administering the
examination.
Item 7 ties certification fees to chapter 42 only.
Items 8, 14, 15, 16, 17, 18, 19, 21, 22, 23, 27, 28, 29, 30,
31, 32, 33, 34, 35, 36, 51, 52, 53, 58, 59, 79, 80, 81, 82, 83, 84, 85, 86, 87,
88, 89, 90, 91, 92, 94, 95, 96, 97, 101, and 102 are amended or proposed because
of an agreement with the NRC that requires that the Bureau adopt certain
language.
Item 10 changes the registration of facilities that are
required to register with the agency from personnel dosimetry services to
processor services. Personnel dosimetry services are already regulated by the
federal government but processor services are not. Many of the problems with
poor quality X–ray films are the result of processors.
Item 11 requires a permanent location with a
non–wireless telephone for persons in order to obtain a registration or
license. The term “non–wireless” is from federal language.
This will allow the department to distinguish between in–state and
out–of–state businesses in order to determine regular versus
reciprocity fees.
Items 12 and 20 change the number of days to match other
references allowing three working days.
Item 13 corrects references and deletes a procedure that has
not been used for several years.
Items 26, 41, 54, 55, and 98 correct language or
references.
Items 42 and 43 have portions stricken because the
manufacturers provide the information required.
Items 44 and 46 are for clarification.
Item 45 places a portion of the law into the rules to allow
easier enforcement.
Items 48, 49, 60, 61, 62, and 76 correct language that is
accepted nationally and published by the Conference of Radiation Control Program
Directors, Inc. (CRCPD) and on which the Bureau’s X–ray compliance
program is based.
Items 66, 67, 68, 69, 70, 71, 72, 73, and 74 are proposed or
amended because of an agreement with the FDA that requires the department to
adopt certain language.
Item 77 adds grounds for discipline to the operator
certification rules when an operator performs exposures that the operator is not
trained or authorized to perform. This is important in preventing unnecessary
patient exposure and misdiagnosis.
Item 78 corrects the name of the national accrediting
body.
In Item 99, a subrule is rescinded because the information
required is included on the application form.
Item 104 adds language that was omitted when the rules were
amended in 1998; it is important that the warnings are read by the customer
annually in order to remind the customer about the possible hazards of
tanning.
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 March 1, 2000.
Such written materials should be directed to Donald A. Flater, Chief, Bureau of
Radiological Health, Department of Public Health, Lucas State Office Building,
Des Moines, Iowa 50319; fax: (515)242–6284; orE–mail:
dflater@idph.state.ia.us.
A public hearing will be held on February 29, 2000, at 8:30
a.m., Conference Room, Fifth Floor South, Side 1, Lucas State Office Building,
Des Moines, Iowa 50319, at which time persons may present their views 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 a public hearing and has
special requirements such as hearing or mobility impairments should contact the
Department of Public Health to advise of specific needs.
These amendments are intended to implement Iowa Code chapter
136C.
The following amendments are proposed.
ITEM 1. Amend the title of
641—Chapter 38 as follows:
CHAPTER 38
GENERAL PROVISIONS FOR RADIATION MACHINES
AND RADIOACTIVE MATERIALS
ITEM 2. 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, 1999
May 10, 2000.
ITEM 3. Amend rule
641-38.2(136C) as follows:
Amend the following definitions:
“Background radiation” means radiation from cosmic
sources,; naturally occurring radioactive materials,
including radon, (except as a decay product of source or
special nuclear material, ); and
including global fallout as it exists in the environment from
the testing of nuclear explosive devices or from past nuclear accidents such
as Chernobyl that contribute to background radiation and are not under the
control of the licensee. “Background radiation” does not
include sources of radiation from radioactive materials regulated by the
agency.
“Beam monitoring system” means a system designed
and installed in the radiation head to detect and measure the radiation
present in the useful beam.
“High radiation area” means an area, accessible to
individuals, in which radiation levels from radiation sources external to the
body could result in an individual’s receiving a dose equivalent in
excess of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from any source of
radiation or 30 centimeters from any surface that the radiation
penetrates.
“Interlock” means a device arranged or
connected such that the occurrence of an event or condition is required before a
second event or condition can occur or continue to occur preventing
the start or continued operation of equipment unless certain predetermined
conditions prevail.
“Irradiation” means the exposure of a living
being or matter to ionizing radiation.
“Misadministration” means the administration
of:
1. to 3. No change.
4. Radiation doses received from teletherapy, linear
accelerator therapy, deep X–ray machine therapy or superficial therapy;
involving the wrong patient or human research subject, wrong mode of treatment
or wrong treatment site;
When the treatment consists of three or fewer fractions
or and the calculated total administered dose differs
from the total prescribed dose by more than 10 percent of the total prescribed
dose;
When the calculated weekly administered dose is 30 percent
greater than the weekly prescribed dose; or
When the calculated total administered dose differs from the
total prescribed dose by more than 20 percent of the total prescribed
dose.
5. and 6. No change.
“Occupational dose” means the dose received by an
individual in the course of employment in which the individual’s assigned
duties involve exposure to radiation from licensed or unlicensed and registered
or unregistered sources of radiation, whether in the possession of the licensee,
registrant, or other person. Occupational dose does not include dose received
from background radiation, as a patient from medical practices,
from any medical administration the individual has received, from exposure to
individuals administered sources of radiation and released in accordance with
41.2(27), from voluntary participation in medical research programs, or as a
member of the public.
“Public dose” means the dose received by a member
of the public from exposure to sources of radiation possessed 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, as a
patient from medical practices, 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.
Adopt the following new definitions in
alphabetical order:
“Barrier” (see “Protective
barrier”).
“Beam axis” means the axis of rotation of the
beam–limiting device.
“Beam–limiting device” means a field
defining collimator, integral to the system, which provides a means to restrict
the dimensions of the X–ray field or useful beam.
“Bone densitometry unit” means a medical device
which uses electronically produced ionizing radiation to determine the density
of bone structures of human patients.
“Critical group” means the group of individuals
reasonably expected to receive the greatest exposure to residual radioactivity
for any applicable set of circumstances.
“Decommission” means to remove a facility or site
safely from service and reduce residual radioactivity to a level that
permits:
1. Release of the property for unrestricted use and
termination of the license; or
2. Release of the property under restricted conditions and
termination of the license.
“Detector” (see “Radiation
detector”).
“Distinguishable from background” means that the
detectable concentration of a radionuclide is statistically different from the
background concentration of that radionuclide in the vicinity of the site or, in
the case of structures, in similar materials using adequate measurement
technology, survey, and statistical techniques.
“Kilovolt (kV)(kilo electron volt (keV))” means
the energy equal to that acquired by a particle with one electron charge in
passing through a potential difference of 1000 volts in a vacuum.
“Lead equivalent” means the thickness of lead
affording the same attenuation, under specified conditions, as the material in
question.
“Leakage radiation” means radiation emanating from
the diagnostic or therapeutic source assembly except for:
1. The useful beam, and
2. Radiation produced when the exposure switch or timer is not
activated.
“Lens dose equivalent (LDE)” applies to the
external exposure of the lens of the eye and is taken as the dose equivalent at
a tissue depth of 0.3 centimeter (300 mg/cm2).
“Light field” means that area of the intersection
of the light beam from the beam–limiting device and one of the set of
planes parallel to and including the plane of the image receptor, whose
perimeter is the locus of points at which the illumination is one–fourth
of the maximum in the intersection.
“mA” means milliampere.
“Mammogram” means an image produced through
radiography of the breast.
“Mammography” means radiography of the
breast.
“Mammography unit” means an assemblage of
components for the production of X–rays for use during mammography,
including, at a minimum: an X–ray generator, an X–ray control, a
tube housing assembly, a beam–limiting device, and the supporting
structures for these components.
“Primary protective barrier” (see
“Protective barrier”).
“Protective barrier” means a barrier used to
reduce radiation exposure. The types of protective barriers are as
follows:
1. “Primary protective barrier” means the
material, excluding filters, placed in the useful beam, for protection purposes,
to reduce the radiation exposure.
2. “Secondary protective barrier” means a barrier
sufficient to attenuate the stray radiation to the required degree.
“Radiation detector” means a device which, in the
presence of radiation, provides a signal or other indication suitable for use in
measuring one or more quantities of incident radiation.
“Radiographic imaging system” means any system
whereby a permanent or semipermanent image is recorded on an image receptor by
the action of ionizing radiation.
“Residual radioactivity” means radioactivity in
structures, materials, soils, groundwater, and other media at a site resulting
from activities under the licensee’s control. This includes radioactivity
from all licensed and unlicensed sources used by the licensee, but excludes
background radiation. It also includes radioactive materials remaining at the
site as a result of radioactive material at the site and previous burials at the
site, even if those burials were made in accordance with the provisions of
641-Chapter 40 or any previous state or federal
licenses, rules or regulations.
“Secondary dose monitoring system” means a system
which will terminate irradiation in the event of failure of the primary dose
monitoring system.
“Secondary protective barrier” (see
“Protective barrier”).
“Shutter” means a device attached to the tube
housing assembly which can intercept the entire cross–sectional area of
the useful beam and which has a lead equivalency not less than that of the tube
housing assembly.
“Simulator (radiation therapy simulation system)”
means any X–ray system intended for localizing the volume to be exposed
during radiation therapy and reproducing the position and size of the
therapeutic irradiation field.
“SSD” means the distance between the source and
the skin entrance plane of the patient (see “Target–to–skin
distance (TSD)”).
“Stray radiation” means the sum of leakage and
scattered radiation.
“Target–to–skin distance (TSD)” means
the distance measured along the beam axis from the center of the front surface
of the X–ray target or electron scattering foil to the surface of the
irradiated object or patient.
“Termination of irradiation” means the stopping of
irradiation in a fashion which will not permit continuance of irradiation
without the resetting of operating conditions at the control panel.
“Tube housing assembly” means the tube housing
with tube installed. It includes high–voltage or filament transformers,
or both, and other appropriate elements when such are contained within the tube
housing.
“Very high radiation area” means an area,
accessible to individuals, in which radiation levels from radiation sources
external to the body could result in an individual’s receiving an absorbed
dose in excess of 500 rad (5 Gy) in 1 hour at 1 meter from a source of radiation
or 1 meter from any surface that the radiation penetrates.
Rescind the following definition:
“Eye dose equivalent” means the external
dose equivalent to the lens of the eye at a tissue depth of 0.3 centimeter (300
mg/cm2).
ITEM 4. Amend subrule 38.3(1) as
follows:
38.3(1) General provision. The agency may, upon
application therefor or upon its own initiative, grant such exemptions or
exceptions from the requirements of these rules the rules in
641-Chapters 38 to 46 as it
determines are authorized by law and will not result in undue hazard to public
health and safety or property. Application for exemptionsor exceptions
should be made in accordance with
641-Chapter 178.
ITEM 5. Amend subrule 38.8(1),
paragraph “a,” as follows:
a. Each registrant shall, at the time of registration and the
anniversary date thereafter, as long as the registrant owns the radiation
machine, remit to the agency a fee sufficient to defray the cost of registering
the equipment with the department. All fees shall be paid annually in the form
of a check or money order made payable to the Iowa Department of Public Health.
The fees to be paid shall be in the amount computed by the following
schedule:
ANNUAL FEE SCHEDULE
|
|
Type of X–ray machine
|
Fee per tube
|
Maximum fee
|
1.
|
Medical
|
$51
|
$1500
|
2.
|
Osteopathy
|
$51
|
$1500
|
3.
|
Chiropractic
|
$51
|
$1500
|
4.
|
Dentistry
|
$39
|
$1000
|
5.
|
Podiatry
|
$39
|
$1000
|
6.
|
Veterinary Medicine
|
$25
|
––
|
7.
|
(Industrial/ Nonmedical Use)
|
$50
|
––
|
8.
|
Food Sterilization
|
$80 $1000
|
––
|
9.
|
Accelerators
|
$100
|
––
|
10.
|
Electron Microscope
|
$20
|
––
|
11.
|
Bone Densitometry
|
$25
|
––
|
ITEM 6. Amend subrule 38.8(3),
paragraph “a,” as follows:
a. A nonrefundable fee of $100 $125
shall be submitted with each application for taking an industrial
radiography examination to become certified by the agency.
ITEM 7. Amend subrule 38.8(6),
introductory paragraph, as follows:
38.8(6) Certification fees. Diagnostic radiographers,
radiation therapists, and nuclear medicine technologists (as defined in
641-Chapter 42), other than
licensed practitioners of the healing arts, are required to pay fees sufficient
to defray the cost of administering 641—Chapter 42. Fees are as
follows:
ITEM 8. Adopt new rule
641-38.10(136C) as follows:
641-38.10(136C)
Deliberate misconduct.
38.10(1) Any licensee, registrant, applicant for a
license or certificate of registration, employee of a licensee, registrant or
applicant; or any contractor (including a supplier or consultant),
subcontractor, employee of a contractor or subcontractor of any licensee or
registrant or applicant for a license or certificate of registration, who
knowingly provides to any licensee, applicant, registrant, contractor, or
subcontractor any components, equipment, materials, or other goods or services
that relate to a licensee’s, registrant’s or applicant’s
activities in this rule, may not:
a. Engage in deliberate misconduct that causes or would have
caused, if not detected, a licensee, registrant, or applicant to be in violation
of any rule, regulation, or order; or any term, condition, or limitation of any
license or registration issued by the agency; or
b. Deliberately submit to the agency, a licensee, registrant,
an applicant, or a licensee’s, registrant’s, or applicant’s
contractor or subcontractor, information that the person submitting the
information knows to be incomplete or inaccurate in some respect material to the
agency.
38.10(2) A person who violates paragraph
38.10(1)“a” or “b” may be subject to enforcement action
in accordance with the procedures in
641-38.9(136C).
38.10(3) For the purposes of paragraph
38.10(1)“a,” deliberate misconduct by a person means an intentional
act or omission that the person knows:
a. Would cause a licensee, registrant, or applicant to be in
violation of any rule, regulation, or order; or any term, condition, or
limitation of any license issued by the agency; or
b. Constitutes a violation of a requirement, procedure,
instruction, contract, purchase order, or policy of a licensee, registrant,
applicant, contractor, or subcontractor.
ITEM 9. 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,
1999 May 10, 2000.
ITEM 10. Amend subrule 39.3(2),
paragraph “a,” as follows:
a. Apply for registration of such facility with the agency
prior to the operation of a radiation machine facility. In order to register
equipment, the person must have a permanent office located in Iowa that has a
non–wireless telephone, employee and equipment, and storage for
records regarding the equipment and operator certification. Application for
registration shall be completed on forms furnished by the agency and shall
include the appropriate fee from 641—38.8(136C).
ITEM 11. Amend subrule 39.3(3),
paragraph “d,” as follows:
d. For the purpose of 39.3(3), services may include but shall
not be limited to:
(1) Installation and servicing of radiation machines and
associated radiation machine components;
(2) Calibration of radiation machines or radiation measurement
instruments or devices;
(3) Radiation protection or health physics consultations or
surveys; and
(4) Personnel dosimetry services.
Processor or processor servicing, or both.
ITEM 12. Amend subrule 39.3(10),
paragraph “a,” introductory paragraph, as follows:
a. Whenever any radiation machine is to be brought into the
state, for any temporary use, the person proposing to bring such machine into
the state shall give written notice to the agency at least two
three working days before such machine is to be used in the state. The
notice shall include:
ITEM 13. Amend subrule 39.4(24) as
follows:
39.4(24) Filing applications for specific
licenses.
a. to d. No change.
e. In the application, the applicant may incorporate
by reference information contained in previous applications, statements, or
reports filed with the agency, provided such references are clear and
specific.
f e. Applications and documents
submitted to the agency may be made available for public inspection except that
the agency may withhold any document or part thereof from public inspection if
disclosure of its content is not required in the public interest and would
adversely affect the interest of a person concerned.
g f. (1) Each application to possess
radioactive materials in unsealed form, on foils or plated sources, or sealed in
glass in excess of the quantities in Appendix G of this chapter, must contain
either:
1. and 2. No change.
(2) One or more of the following factors may be used to
support an evaluation submitted under
39.4(24)“g”(1)“1”
39.4(24)“f”(1)“1” of this subrule:
1. to 7. No change.
(3) An emergency plan for responding to a release of
radioactive material submitted under
39.4(24)“g”(1)“2”
39.4(24)“f”(1)“2” must include the following
information:
1. to 13. No change.
(4) No change.
ITEM 14. Amend subrule 39.4(26),
paragraph “e,” as follows:
e. Each decommissioning funding plan must contain a cost
estimate for decommissioning and a description of the method of assuring funds
for decommissioning from 39.4(26)“f,” including means of adjusting
cost estimates and associated funding levels periodically over the life of the
facility. The decommissioning funding plan must also contain a certification
by the licensee that financial assurance for decommissioning has been provided
in the amount of the cost estimate and a signed original of the financial
instrument obtained to satisfy the requirements of
39.4(26)“f.”
ITEM 15. Amend subparagraph
39.4(26)“f”(2) as follows:
(2) A surety method, insurance, or other guarantee method.
These methods guarantee that decommissioning costs will be paid should the
licensee default. A surety method may be in the form of a surety bond, letter
of credit, or line of credit. A parent company guarantee of funds for
decommissioning costs based on a financial test may be used if the guarantee and
test are as contained in Appendix F of this chapter. A parent company guarantee
may not be used in combination with other financial methods to satisfy the
requirements of this subrule. For commercial corporations that issue bonds,
a guarantee of funds by the applicant or licensee for decommissioning costs
based on a financial test may be used if the guarantee and test are as contained
in Appendix H of this chapter. For commercial companies that do not issue
bonds, a guarantee of funds by the applicant or licensee for decommissioning
costs may be used if the guarantee and test are as contained in Appendix I of
this chapter. For nonprofit entities, such as colleges, universities, and
nonprofit hospitals, a guarantee of funds by the applicant or licensee may be
used if the guarantee and test are as contained in Appendix J of this chapter.
A guarantee by the applicant or licensee may not be used in combination with any
other financial methods used to satisfy the requirements of paragraph
39.4(26)“f”or in any situation where the applicant or licensee has a
parent company holding majority control of the voting stock of the company.
Any surety method or insurance used to provide financial assurance for
decommissioning must contain the following conditions:
ITEM 16. Amend subrule 39.4(26),
paragraph “f,” by adopting new subparagraph
(5) as follows:
(5) When a governmental entity assumes custody and ownership
of a site, an arrangement that is deemed acceptable by such governmental
entity.
ITEM 17. Rescind subrule
39.4(27), paragraph “e,” and adopt the
following new paragraph in lieu thereof:
e. Use of sealed sources in industrial radiography. In
addition to the requirements set forth in 39.4(25), a specific license for use
of sealed sources in industrial radiography will be issued if the application
contains:
(1) A schedule or description of the program for training
radiographic personnel which specifies:
1. Initial training,
2. Periodic training,
3. On–the–job training, and
4. Methods to be used by the licensee to determine the
knowledge, understanding, and ability of radiographic personnel to comply with
agency rules, licensing requirements, and the operating and emergency procedures
of the applicant;
(2) Written operating and emergency procedures, including all
items listed in Appendix D of 641—Chapter 45;
(3) A description of the internal inspection system or other
management control to ensure that radiographic personnel follow license
provisions, rules of the agency, and the applicant’s operating and
emergency procedures;
(4) A list of permanent radiographic installations and
descriptions of permanent storage and use locations. Radioactive material shall
not be stored at a permanent storage location or used at a permanent use
location unless such storage or use location is specifically authorized by the
license. A storage or use location is permanent if radioactive material is
stored at the location for more than 90 days and any of the following applies to
the location:
1. Non–wireless telephone service is established by the
licensee;
2. Industrial radiographic services are advertised for or from
the location;
3. Industrial radiographic operations are conducted at other
sites due to arrangements made from the location;
(5) A description of the organization of the industrial
radiographic program, including delegations of authority and responsibility for
operation of the radiation safety program;
(6) A description of the program for inspection and
maintenance of radiographic exposure devices and transportand storage containers
(including applicable items in 641— subrule 45.1(8) and
641-Chapter 45, Appendix A); and
(7) If a license application includes underwater radiography,
a description of:
1. Radiation safety procedures and radiographer
responsibilities unique to the performance of underwater radiography;
2. Radiographic equipment and radiation safety equipment
unique to underwater radiography; and
3. Methods for gas–tight encapsulation of
equipment;
(8) If a license application includes offshore platform or
lay–barge radiography, a description of:
1. Transport procedures for radioactive material to be used in
industrial radiographic operations;
2. Storage facilities for radioactive material; and
3. Methods for restricting access to radiation
areas.
ITEM 18. Amend subparagraph
39.4(33)“j”(2), introductory paragraph, as follows:
(2) Conduct a radiation survey of the premises where the
licensed activities were carried out and submit a report of the results of this
survey unless the licensee demonstrates that the premises are suitable
for release in some other manner in some other manner that the
premises are suitable for release in accordance with the criteria for
decommissioning in
641-
40.28(136C) through
641-40.31(136C). The licensee
shall, as appropriate:
ITEM 19. Amend subparagraph
39.4(33)“k”(3) as follows:
(3) A radiation survey has been performed which demonstrates
that the premises are suitable for release in accordance with state of
Iowa requirements; or other information submitted by the licensee is
sufficient to demonstrate that the premises are suitable for release in
accordance with state of Iowa requirements the criteria for
decommissioning in
641-
40.28(136C) through
641-40.31(136C).
ITEM 20. Amend subparagraph
39.4(90)“a”(3) as follows:
(3) The out–of–state licensee shall notify the
agency in writing at least three working days prior to engaging in
activities in the state. Such notification shall indicate the location, period,
and type of proposed possession and use within the state, and shall be
accompanied by a copy of the pertinent licensing document initially. If, for a
specific case, the three–day period would impose an undue hardship on the
out–of–state licensee, the licensee may, upon application to the
agency, obtain permission to proceed sooner. The agency may waive the
requirement for filing additional written notifications during the remainder of
the one–year reciprocity period following the receipt of the initial
notification from a person engaging in activities under the general license
provided by 39.4(90)“a.”
ITEM 21. Rescind rule
641-39.5(136C) and adopt the following
new rule in lieu thereof:
641—39.5(136C) Transportation of radioactive
material. All persons who transport radioactive material or deliver
radioactive material to a carrier for transport must comply with the provision
contained in 10 CFR Part 71 as it applies to the state of Iowa.
ITEM 22. Rescind and reserve
641-Chapter 39, Appendix
E.
ITEM 23. Amend 641—Chapter
39 by adopting the following new Appendices H, I and
J:
Appendix H
Criteria Relating to Use of Financial Tests
and Self–Guarantees for Providing Reasonable Assurance of Funds for
Decommissioning
I. Introduction
An applicant or licensee may provide reasonable assurance of
the availability of funds for decommissioning based on furnishing its own
guarantee that funds will be available for decommissioning costs and on a
demonstration that the company passes the financial test of Section II of this
appendix. The terms of the self–guarantee are in Section III of this
appendix. This appendix establishes criteria for passing the financial test for
the self–guarantee and establishes the terms for a
self–guarantee.
II. Financial Test
A. To pass the financial test, a company must meet all of the
following criteria:
1. Tangible net worth at least ten times the total current
decommissioning cost estimate for the total of all facilities or parts thereof
(or the current amount required if certification is used).
2. Assets located in the United States amounting to at least
90 percent of total assets or at least ten times the total current
decommissioning cost estimate for the total of all facilities or parts thereof
(or the current amount required if certification is used).
3. A current rating for its most recent bond issuance of AAA,
AA, or A as issued by Standard and Poor’s (S&P) or Aaa, Aa, or A as
issued by Moody’s.
B. To pass the financial test, a company must meet all of the
following additional requirements:
1. The company must have at least one class of equity
securities registered under the Securities Exchange Act of 1934.
2. The company’s independent certified public accountant
must have compared the data used by the company in the financial test, which is
derived from the independently audited, year–end financial statements for
the latest fiscal year, with the amounts in such financial statement. In
connection with that procedure, the licensee shall inform the agency within 90
days of any matters coming to the attention of the auditor that cause the
auditor to believe that the data specified in the financial test should be
adjusted and that the company no longer passes the test.
3. After the initial financial test, the company must repeat
passage of the test within 90 days after the close of each succeeding fiscal
year.
C. If the licensee no longer meets the requirements of Section
II.A. of this appendix, the licensee must send immediate notice to the agency of
its intent to establish alternate financial assurance as specified in these
rules within 120 days of such notice.
III. Company Self–Guarantee
The terms of a self–guarantee which an applicant or
licensee furnishes must provide that:
A. The guarantee will remain in force unless the licensee
sends notice of cancellation by certified mail, return receipt requested, to the
agency. Cancellation may not occur, however, during the 120 days beginning on
the date of receipt of the notice of cancellation by the agency, as evidenced by
the return receipt.
B. The licensee shall provide alternative financial assurance
as specified in these rules within 90 days following receipt by the agency of a
notice of cancellation of the guarantee.
C. The guarantee and financial test provisions must remain in
effect until the agency has terminated the license or until another financial
assurance method acceptable to the agency has been put in effect by the
licensee.
D. The licensee will promptly forward to the agency and the
licensee’s independent auditor all reports covering the latest fiscal year
filed by the licensee with the Securities and Exchange Commission pursuant to
the requirements of Section 13 of the Securities and Exchange Act of
1934.
E. If, at any time, the licensee’s most recent bond
issuance ceases to be rated in any category of “A” or above by
either Standard and Poor’s or Moody’s, the licensee will provide
notice in writing of such fact to the agency within 20 days after publication of
the change by the rating service. If the licensee’s most recent bond
issuance ceases to be rated in any category of A or above by both Standard and
Poor’s and Moody’s, the licensee no longer meets the requirements of
Section II.A. of this appendix.
F. The applicant or licensee must provide to the agency a
written guarantee (a written commitment by a corporate officer) which states
that the licensee will fund and carry out the required decommissioning
activities or, upon issuance of an order by the agency, the licensee will set up
and fund a trust in the amount of the current cost estimates for
decommissioning.
Appendix I
Criteria Relating to Use of Financial Tests
and Self–Guarantee for Providing Reasonable Assurance of Funds for
Decommissioning by Commercial Companies That Have No Outstanding Rated
Bonds
I. Introduction
An applicant or licensee may provide reasonable assurance of
the availability of funds for decommissioning based on furnishing its own
guarantee that funds will be available for decommissioning costs and on a
demonstration that the company passes the financial test of Section II of this
appendix. The terms of the self–guarantee are in Section III of this
appendix. This appendix establishes criteria for passing the financial test for
the self–guarantee and establishes the terms for a
self–guarantee.
II. Financial Test
A. To pass the financial test, a company must meet the
following criteria:
1. Tangible net worth greater than $10 million, or at least
ten times the total current decommissioning cost estimate (or the current amount
required if certification is used), whichever is greater, for all
decommissioning activities for which the company is responsible as
self–guaranteeing licensee and as parent–guarantor.
2. Assets located in the United States amounting to at least
90 percent of total assets or at least ten times the total current
decommissioning cost estimate (or the current amount required if certification
is used) for all decommissioning activities for which the company is responsible
as self–guaranteeing licensee and as parent–guarantor.
3. A ratio of cash flow divided by total liabilities greater
than 0.15 and a ratio of total liabilities divided by net worth less than
1.5.
B. In addition, to pass the financial test, a company must
meet all of the following requirements:
1. The company’s independent certified public accountant
must have compared the data used by the company in the financial test, which is
required to be derived from the independently audited year–end financial
statement based on United States generally accepted accounting practices for the
latest fiscal year, with the amounts in such financial statement. In connection
with that procedure, the licensee shall inform the agency within 90 days of any
matters that may cause the auditor to believe that the data specified in the
financial test should be adjusted and that the company no longer passes the
test.
2. After the initial financial test, the company must repeat
passage of the test within 90 days after the close of each succeeding fiscal
year.
3. If the licensee no longer meets the requirements of Section
II.A. of this appendix, the licensee must send notice to the agency of intent to
establish alternative financial assurance as specified in these rules. The
notice must be sent by certified mail, return receipt requested, within 90 days
after the end of the fiscal year for which the year–end financial data
show that the licensee no longer meets the financial test requirements. The
licensee must provide alternative financial assurance within 120 days after the
end of such fiscal year.
III. Company Self–Guarantee
The terms of a self–guarantee which an applicant or
licensee furnishes must provide that:
A. The guarantee shall remain in force unless the licensee
sends notice of cancellation by certified mail, return receipt requested, to the
agency. Cancellation may not occur until an alternative financial assurance
mechanism is in place.
B. The licensee shall provide alternative financial assurance
as specified in these rules within 90 days following receipt by the agency of a
notice of cancellation of the guarantee.
C. The guarantee and financial test provisions must remain in
effect until the agency has terminated the license or until another financial
assurance method acceptable to the agency has been put in effect by the
licensee.
D. The applicant or licensee must provide to the agency a
written guarantee (a written commitment by a corporate officer) which states
that the licensee will fund and carry out the required decommissioning
activities or, upon issuance of an order by the agency, the licensee will set up
and fund a trust in the amount of the current cost estimates for
decommissioning.
Appendix J
Criteria Relating to Use of Financial Tests
and Self–Guarantee for Providing Reasonable Assurance of Funds for
Decommissioning by Nonprofit Colleges, Universities, and Hospitals
I. Introduction
An applicant or licensee may provide reasonable assurance of
the availability of funds for decommissioning based on furnishing its own
guarantee that funds will be available for decommissioning costs and on a
demonstration that the applicant or licensee passes the financial test of
Section II of this appendix. The terms of the self–guarantee are in
Section III of this appendix. This appendix establishes criteria for passing
the financial test for the self–guarantee and establishes the terms for a
self–guarantee.
II. Financial Test
A. For colleges and universities to pass the financial test, a
college or university must meet either the criteria in Section II.A.1. or the
criteria in Section II.A.2. of this appendix.
1. For applicants or licensees that issue bonds, a current
rating for its most recent uninsured, uncollateralized, and unencumbered bond
issuance of AAA, AA, or A as issued by Standard and Poor’s (S&P) or
Aaa, Aa, or A as issued by Moody’s.
2. For applicants or licensees that do not issue bonds,
unrestricted endowment consisting of assets located in the United States of at
least $50 million, or at least 30 times the total current decommissioning cost
estimate (or the current amount required if certification is used), whichever is
greater, for all decommissioning activities for which the college or university
is responsible as a self–guaranteeing licensee.
B. For hospitals to pass the financial test, a hospital must
meet either the criteria in Section II.B.1. or the criteria in Section II.B.2.
of this appendix:
1. For applicants or licensees that issue bonds, a current
rating for its most recent uninsured, uncollateralized, and unencumbered bond
issuance of AAA, AA, or A as issued by Standard and Poor’s (S&P) or
Aaa, Aa, or A as issued by Moody’s.
2. For applicants or licensees that do not issue bonds, all
the following tests must be met:
(a) (Total revenues less total expenditures) divided by total
revenues must be equal to or greater than 0.04.
(b) Long–term debt divided by net fixed assets must be
less than or equal to 0.67.
(c) (Current assets and depreciation fund) divided by current
liabilities must be greater than or equal to 2.55.
(d) Operating revenues must be at least 100 times the total
current decommissioning cost estimate (or the current amount required if
certification is used) for all decommissioning activities for which the hospital
is responsible as a self–guaranteeing licensee.
C. In addition, to pass the financial test, a licensee must
meet all the following requirements:
1. The licensee’s independent certified public
accountant must have compared the data used by the licensee in the financial
test, which is required to be derived from the independently audited
year–end financial statements, based on United States generally accepted
accounting practices, for the latest fiscal year, with the amounts in such
financial statement. In connection with that procedure, the licensee shall
inform this agency within 90 days of any matters coming to the attention of the
auditor that cause the auditor to believe that the data specified in the
financial test should be adjusted and that the licensee no longer passes the
test.
2. After the initial financial test, the licensee must repeat
passage of the test within 90 days after the close of each succeeding fiscal
year.
3. If the licensee no longer meets the requirements of Section
I of this appendix, the licensee must send notice to this agency of its intent
to establish alternative financial assurance as specified in these rules. The
notice must be sent by certified mail, return receipt requested, within 90 days
after the end of the fiscal year for which the year–end financial data
show that the licensee no longer meets the financial test requirements. The
licensee must provide alternate financial assurance within 120 days after the
end of such fiscal year.
III. Self–Guarantee
The terms of a self–guarantee which an applicant or
licensee furnishes must provide that:
A. The guarantee shall remain in force unless the licensee
sends notice of cancellation by certified mail, return receipt requested, to the
agency. Cancellation may not occur unless an alternative financial assurance
mechanism is in place.
B. The licensee shall provide alternative financial assurance
as specified in these rules within 90 days following receipt by the agency of a
notice of cancellation of the guarantee.
C. The guarantee and financial test provisions must remain in
effect until the agency has terminated the license or until another financial
assurance method acceptable to the agency has been put in effect by the
licensee.
D. The applicant or licensee must provide to the agency a
written guarantee (a written commitment by a corporate officer or officer of the
institution) which states that the licensee will fund and carry out the required
decommissioning activities or, upon issuance of an order by the agency, the
licensee will set up and fund a trust in the amount of the current cost
estimates for decommissioning.
E. If, at any time, the licensee’s most recent bond
issuance ceases to be rated in any category of “A” or above by
either Standard and Poor’s or Moody’s, the licensee shall provide
notice in writing of such fact to the agency within 20 days after publication of
the change by the rating service.
ITEM 24. 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 July 1,
1999 May 10, 2000.
ITEM 25. Amend subrule 40.2(2),
definitions of “Declared pregnant woman” and “Very high
radiation area,” as follows:
“Declared pregnant woman” means a woman who has
voluntarily informed her employer, 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.
“Very high radiation area” means an area,
accessible to individuals, in which radiation levels could result in an
individual receiving an absorbed dose in excess of 500 rad (5 Gy) in 1 hour at 1
meter from a source of radiation or from any surface that the radiation
penetrates.
ITEM 26. Amend subrule 40.10(2) as
follows:
40.10(2) The licensee or registrant shall use, to the
extent practicable practical, procedures and engineering
controls based upon sound radiation protection principles to achieve
occupational doses and public doses that are as low as is reasonably achievable
(ALARA).
ITEM 27. Amend subparagraph
40.15(1)“b”(1) as follows:
(1) An eye A lens dose equivalent of
15 rem (0.15 Sv), and
ITEM 28. Amend subrule 40.15(3) as
follows:
40.15(3) The assigned deep dose equivalent and shallow
dose equivalent shall be for the portion of the body receiving the highest
exposure determined as follows:
The deep dose equivalent, eye lens
dose equivalent and shallow dose equivalent may be assessed from surveys or
other radiation measurements for the purpose of demonstrating compliance with
the occupational dose limits, if the individual monitoring device was not in the
region of highest potential exposure, or the results of individual monitoring
are unavailable.
ITEM 29. Amend subrule 40.20(1) as
follows:
40.20(1) The licensee or registrant authorizes a
planned special exposure only in an exceptional situation when alternatives that
might avoid the higher exposure dose estimated to result
from the planned special exposure are unavailable or impractical.
ITEM 30. Amend rule
641-40.22(136C) as follows:
641—40.22(136C) Dose equivalent to an
embryo/fetus.
40.22(1) The licensee or registrant shall ensure that
the dose equivalent to an embryo/fetus during the entire pregnancy, due
to occupational exposure of a declared pregnant woman, does not exceed 0.5 rem
(5 mSv). See 40.86(136C) for record–keeping requirements.
40.22(2) No change.
40.22(3) The dose equivalent to an embryo/fetus
shall be taken as the sum of:
a. The deep dose equivalent to the declared pregnant woman;
and
b. The dose equivalent to the embryo/fetus from
radionuclides in the embryo/fetus and radionuclides in the declared pregnant
woman.
40.22(4) If by the time the woman declares pregnancy
to the licensee or registrant, the dose equivalent to the embryo/fetus
has exceeded 0.45 rem, (4.5 mSv), the licensee or registrant shall be deemed to
be in compliance with 40.22(1) if the additional dose equivalent to the
embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the
pregnancy.
ITEM 31. Amend subparagraph
40.36(1)“b”(1) as follows:
(1) Radiation The magnitude and extent of
radiation levels; and
ITEM 32. Amend subrule 40.62(2) as
follows:
40.62(2) Rooms or other areas in hospitals that are
occupied by patients are not required to be posted with caution signs pursuant
to 40.61(136C) provided that the patient could be released from
confinement licensee control pursuant to
641—41.27(136C) 641—subrule
41.2(27).
ITEM 33. Amend rule
641-40.62(136C) by adopting new
subrule 40.62(5) as follows:
40.62(5) Rooms in hospitals or clinics that are used
for teletherapy are exempt from the requirement to post caution signs under
40.61(136C) if:
a. Access to the room is controlled pursuant to 641—
subrule 41.2(53); and
b. Personnel in attendance take necessary precautions to
prevent an inadvertent exposure of workers, other patients, and members of the
public to radiation in excess of the limits established in this
chapter.
ITEM 34. Rescind rule
641-40.75(136C) and adopt the following
new rule in lieu thereof:
641—40.75(136C) Transfer for disposal and
manifests.
40.75(1) Any licensee shipping radioactive waste
intended for ultimate disposal at a licensed land disposal facility must
document the information required on the Uniform Low–Level Radioactive
Waste Manifest and transfer this recorded manifest information to the intended
consignee in accordance with Appendix D of this chapter.
40.75(2) Each shipment manifest must include a
certification by the waste generator as specified in Section II of Appendix D of
this chapter.
40.75(3) Each person involved in the transfer for
disposal and disposal of waste, including the waste generator, waste collector,
waste processor, and disposal facility operator, shall comply with the
requirements specified in Section III of Appendix D of this chapter.
ITEM 35. Amend rule
641-40.80(136C) as follows:
641—40.80(136C) General provisions.
40.80(1) Each licensee or registrant shall use the
special units curie, rad, rem and roentgen, counts per minute (cpm),
disintegrations per minute (dpm), or the SI units becquerel, gray, sievert and
coulomb per kilogram, including multiples and subdivisions, and shall clearly
indicate the units of all quantities on records required by this
chapter.
40.80(2) The licensee or registrant shall make a clear
distinction among the quantities entered on the records required by this
chapter, such as, total effective dose equivalent, total organ dose equivalent,
shallow dose equivalent, eye lens dose equivalent, deep
dose equivalent, or committed effective dose equivalent.
40.80(3) In the records required by this
chapter, the licensee may record quantities in SI units in parentheses following
each of the units specified in 40.80(1). However, all quantities must be
recorded as stated in 40.80(1).
40.80(4) Notwithstanding the requirements of
40.80(1), when recording information on shipment manifests, as required in
641-40.75(136C), information must be
recorded in the International System of Units (SI) or in SI and units as
specified in 40.80(1).
ITEM 36. Rescind
641-Chapter 40, Appendix D, and adopt
new Appendix D as follows:
Appendix D
Requirements for Transfers of Low–Level
Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and
Manifests
As used in this appendix, the following definitions
apply:
“Chelating agent” means amine polycarboxylic acids
(e.g., EDTA, DTPA), hydroxycarboxylic acids, and polycarboxylic acids (e.g.,
citric acid, carbolic acid, and glucinic acid).
“Chemical description” means a description of the
principal chemical characteristics of a low–level radioactive
waste.
“Computer–readable medium” means that the
regulatory agency’s computer can transfer the information from the medium
into its memory.
“Consignee” means the designated receiver of the
shipment of low–level radioactive waste.
“Decontamination facility” means a facility
operating under an Agreement State or Nuclear Regulatory Commission license
whose principal purpose is decontamination of equipment or materials to
accomplish recycle, reuse, or other waste management objectives and, for
purposes of this appendix, is not considered to be a consignee for LLW
shipments.
“Disposal container” means a container principally
used to confine low–level radioactive waste during disposal operations at
a land disposal facility (also see “high integrity container”).
Note that for some shipments, the disposal container may be the transport
package.
“EPA identification number” means the number
received by a transporter following application to the administrator of EPA as
required by 40 CFR Part 263.
“Forms 540, 540A, 541, 541A, 542, and 542A” are
official forms referenced in this appendix. Licensees need not use originals of
these forms as long as any substitute forms are equivalent to the original
documentation in respect to content, clarity, size, and location of information.
Upon agreement between the shipper and consignee, Forms 541 (and 541A) and Forms
542 (and 542A) may be completed, transmitted, and stored in electronic media.
The electronic media must have the capability for producing legible, accurate,
and complete records in the format of the uniform manifest.
“Generator” means a licensee operating under an
Agreement State or Nuclear Regulatory Commission license who (1) is a waste
generator as defined in this appendix, or (2) is the licensee to whom waste can
be attributed within the context of the Low–Level Radioactive Waste Policy
Amendments Act of 1985 (e.g., waste generated as a result of decontamination or
recycle activities).
“High integrity container (HIC)” means a container
commonly designed to meet the structural stability requirements of 10 CFR 61.56,
and to meet United States Department of Transportation requirements for a Type A
package.
“Land disposal facility” means the land, buildings
and structures, and equipment which are intended to be used for the disposal of
radioactive wastes. For purposes of this appendix, a “geologic
repository” as defined in 10 CFR 60 is not considered a land disposal
facility.
“Package” means the assembly of components
necessary to ensure compliance with the packaging requirements of United States
Department of Transportation regulations, together with its radioactive
contents, as presented for transport.
“Physical description” means the items called for
on Form 541 to describe a low–level radioactive waste.
“Residual waste” means low–level radioactive
waste resulting from processing or decontamination activities that cannot be
easily separated into distinct batches attributable to specific waste
generators. This waste is attributable to the processor or decontamination
facility, as applicable.
“Shipper” means the licensed entity (i.e., the
waste generator, waste collector, or waste processor) who offers low–level
radioactive waste for transportation, typically consigning this type of waste to
a licensed waste collector, waste processor, or land disposal facility
operator.
“Shipping paper” means Form 540 and, if required,
Form 540A which includes the information required by United States Department of
Transportation in 49 CFR Part 172.
“Uniform Low–Level Radioactive Waste
Manifest” or “uniform manifest” means the combination of Forms
540, 541 and, if necessary, 542, and their respective continuation sheets as
needed, or equivalent.
“Waste collector” means an entity, operating under
an Agreement State or Nuclear Regulatory Commission license, whose principal
purpose is to collect and consolidate waste generated by others, and to transfer
this waste, without processing or repackaging the collected waste, to another
licensed waste collector, licensed waste processor, or licensed land disposal
facility.
“Waste description” means the physical, chemical
and radiological description of a low–level radioactive waste as called
for on Form 541.
“Waste generator” means an entity, operating under
an Agreement State or Nuclear Regulatory Commission license, who (1) possesses
any material or component that contains radioactivity or is radioactively
contaminated for which the licensee foresees no further use, and (2) transfers
this material or component to a licensed land disposal facility or to a licensed
waste collector or processor for handling or treatment prior to disposal. A
licensee performing processing or decontamination services may be a “waste
generator” if the transfer of low–level radioactive waste from its
facility is defined as “residual waste.”
“Waste processor” means an entity, operating under
an Agreement State or Nuclear Regulatory Commission license, whose principal
purpose is to process, repackage, or otherwise treat low–level radioactive
material or waste generated by others prior to eventual transfer of waste to a
licensed low–level radioactive waste land disposal facility.
“Waste type” means a waste within a disposal
container having a unique physical description (i.e., a specific waste
descriptor code or description; or a waste sorbed on or solidified in a
specifically defined media).
I. Manifest
A waste generator, collector, or processor who transports, or
offers for transportation, low–level radioactive waste intended for
ultimate disposal at a licensed low–level radioactive waste land disposal
facility must prepare a manifest reflecting information requested on applicable
Forms 540 (Uniform Low–Level Radioactive Waste Manifest (Shipping Paper))
and 541 (Uniform Low–Level Radioactive Waste Manifest (Container and Waste
Description)) and, if necessary, on an applicable Form 542 (Uniform
Low–Level Radioactive Waste Manifest (Manifest Index and Regional Compact
Tabulation)). Forms 540 and 540A must be completed and must physically
accompany the pertinent low–level waste shipment. Upon agreement between
shipper and consignee, Forms 541 and 541A and 542 and 542A may be completed,
transmitted, and stored in electronic media with the capability for producing
legible, accurate, and complete records on the respective forms. Licensees are
not required by this agency to comply with the manifesting requirements of this
part when they ship:
(a) LLW for processing and expect its return (i.e., for
storage under their license) prior to disposal at a licensed land disposal
facility;
(b) LLW that is being returned to the licensee who is the
“waste generator” or “generator,” as defined in this
part; or
(c) Radioactively contaminated material to a “waste
processor” that becomes the processor’s “residual
waste.”
For guidance in completing these forms, refer to the
instructions that accompany the forms. Copies of manifests required by this
appendix may be legible carbon copies, photocopies, or computer printouts that
reproduce the data in the format of the uniform manifest.
Forms 540, 540A, 541, 541A, 542 and 542A, and the accompanying
instructions, in hard copy, may be obtained from the Information and Records
Management Branch, Office of Information Resources Management, U.S. Nuclear
Regulatory Commission, Washington, DC 20555, telephone
(301)415–7232.
This appendix includes information requirements of the United
States Department of Transportation, as codified in 49 CFR Part 172.
Information on hazardous, medical, or other waste required to meet Environmental
Protection Agency regulations, as codified in 40 CFR Parts 259, 261, or
elsewhere, is not addressed in this section, and must be provided on the
required EPA forms. However, the required EPA forms must accompany the Uniform
Low–Level Radioactive Waste Manifest required by this chapter.
Information Requirements
A. General Information
The shipper of the radioactive waste shall provide the
following information on the uniform manifest:
1. The name, facility’s address, and telephone number of
the licensee shipping the waste;
2. An explicit declaration indicating whether the shipper is
acting as a waste generator, collector, processor, or a combination of these
identifiers for purposes of the manifested shipment; and
3. The name, address, and telephone number, or the name and
EPA identification number, for the carrier transporting the waste.
B. Shipment Information
The shipper of the radioactive waste shall provide the
following information regarding the waste shipment on the uniform
manifest:
1. The date of the waste shipment;
2. The total number of packages/disposal containers;
3. The total disposal volume and disposal weight in the
shipment;
4. The total radionuclide activity in the shipment;
5. The activity of each of the radionuclides, H–3,
C–14, Tc–99, and I–129 contained in the shipment;
and
6. The total masses of U–233, U–235, and plutonium
in special nuclear material, and the total mass of uranium and thorium in source
material.
C. Disposal Container and Waste Information
The shipper of the radioactive waste shall provide the
following information on the uniform manifest regarding the waste and each
disposal container of waste in the shipment:
1. An alphabetic or numeric identification that uniquely
identifies each disposal container in the shipment;
2. A physical description of the disposal container, including
the manufacturer and model of any high integrity container;
3. The volume displaced by the disposal container;
4. The gross weight of the disposal container, including the
waste;
5. For waste consigned to a disposal facility, the maximum
radiation level at the surface of each disposal container;
6. A physical and chemical description of the waste;
7. The total weight percentage of chelating agent for any
waste containing more than 0.1 percent chelating agent by weight, plus the
identity of the principal chelating agent;
8. The approximate volume of waste within a
container;
9. The sorbing or solidification media, if any, and the
identity of the solidification media vendor and brand name;
10. The identities and activities of individual radionuclides
contained in each container, the masses of U–233, U–235, and
plutonium in special nuclear material, and the masses of uranium and thorium in
source material. For discrete waste types (i.e., activated materials,
contaminated equipment, mechanical filters, sealed source/devices, and wastes in
solidification/stabilization media), the identities and activities of individual
radionuclides associated with or contained in these waste types within a
disposal container shall be reported;
11. The total radioactivity within each container;
and
12. For wastes consigned to a disposal facility, the
classification of the waste pursuant to 10 CFR 61.55. Waste not meeting the
structural stability requirements of 10 CFR 61.56(b) must be
identified.
D. Uncontainerized Waste Information
The shipper of the radioactive waste shall provide the
following information on the uniform manifest regarding a waste shipment
delivered without a disposal container:
1. The approximate volume and weight of the waste;
2. A physical and chemical description of the waste;
3. The total weight percentage of chelating agent if the
chelating agent exceeds 0.1 percent by weight, plus the identity of the
principal chelating agent;
4. For waste consigned to a disposal facility, the
classification of the waste pursuant to 10 CFR 61.55. Waste not meeting the
structural stability requirements of 10 CFR 61.56(b) must be
identified;
5. The identities and activities of individual radionuclides
contained in the waste, the masses of U–233, U–235, and plutonium in
special nuclear material, and the masses of uranium and thorium in source
material; and
6. For wastes consigned to a disposal facility, the maximum
radiation levels at the surface of the waste.
E. Multigenerator Disposal Container Information
This section applies to disposal containers enclosing mixtures
of waste originating from different generators. (Note: The origin of the LLW
resulting from a processor’s activities may be attributable to one or more
“generators” (including “waste generators”) as defined
in this appendix.) It also applies to mixtures of wastes shipped in an
uncontainerized form, for which portions of the mixture within the shipment
originate from different generators.
1. For homogeneous mixtures of waste, such as incinerator ash,
provide the waste description applicable to the mixture and the volume of the
waste attributed to each generator.
2. For heterogeneous mixtures of waste, such as the combined
products from a large compactor, identify each generator contributing waste to
the disposal container and, for discrete waste types (i.e., activated materials,
contaminated equipment, mechanical filters, sealed source/devices, and wastes in
solidification/stabilization media), the identities and activities of individual
radionuclides contained in these waste types within the disposal container. For
each generator, provide the following:
(a) The volume of waste within the disposal container;
(b) A physical and chemical description of the waste,
including the solidification agent, if any;
(c) The total weight percentage of chelating agents for any
disposal container containing more than 0.1 percent chelating agent by weight,
plus the identity of the principal chelating agent;
(d) The sorbing or solidification media, if any, and the
identity of the solidification media vendor and brand name if the media is
claimed to meet stability requirements in 10 CFR 61.56(b); and
(e) Radionuclide identities and activities contained in the
waste, the masses of U–233, U–235, and plutonium in special nuclear
material, and the masses of uranium and thorium in source material if contained
in the waste.
II. Certification
An authorized representative of the waste generator,
processor, or collector shall certify by signing and dating the shipment
manifest that the transported materials are properly classified, described,
packaged, marked, and labeled and are in proper condition for transportation
according to the applicable regulations of the United States Department of
Transportation and this agency. A collector in signing the certification is
certifying that nothing has been done to the collected waste that would
invalidate the waste generator’s certification.
III. Control and Tracking
A. Any licensee who transfers radioactive waste to a land
disposal facility or a licensed waste collector shall comply with the
requirements in paragraphs A.1. through A.9. of this appendix. Any licensee who
transfers waste to a licensed waste processor for waste treatment or repackaging
shall comply with the requirements of paragraphs A.4. through A.9. of this
appendix. A licensee shall:
1. Prepare all wastes so that the waste is classified
according to 10 CFR 61.55 and meets the waste characteristics requirements in 10
CFR 61.56;
2. Label each disposal container (or transport package if
potential radiation hazards preclude labeling of the individual disposal
container) of waste to identify whether it is Class A waste, Class B waste,
Class C waste, or greater than Class C waste, in accordance with 10 CFR
61.55;
3. Conduct a quality assurance program to ensure compliance
with 10 CFR 61.55 and 61.56 (the program must include management evaluation of
audits);
4. Prepare the Uniform Low–Level Radioactive Waste
Manifest as required by this appendix;
5. Forward a copy or electronically transfer the Uniform
Low–Level Radioactive Waste Manifest to the intended consignee so that
either (1) receipt of the manifest precedes the LLW shipment or (2) the manifest
is delivered to the consignee with the waste at the time the waste is
transferred to the consignee. Using both (1) and (2) is also
acceptable;
6. Include Form 540 (and Form 540A, if required) with the
shipment regardless of the option chosen in paragraph A.5. of this
section;
7. Receive acknowledgment of the receipt of the shipment in
the form of a signed copy of Form 540;
8. Retain a copy of or electronically store the Uniform
Low–Level Radioactive Waste Manifest and documentation of acknowledgment
of receipt as the record of transfer of licensed material as required by
641—subrule 39.4(41); and
9. For any shipments or any part of a shipment for which
acknowledgment of receipt has not been received within the times set forth in
this appendix, conduct an investigation in accordance with paragraph E of this
appendix.
B. Any waste collector licensee who handles only prepackaged
waste shall:
1. Acknowledge receipt of the waste from the shipper within
one week of receipt by returning a signed copy of Form 540;
2. Prepare a new manifest to reflect consolidated shipments
that meet the requirements of this appendix. The waste collector shall ensure
that, for each container of waste in the shipment, the manifest identifies the
generator of that container of waste;
3. Forward a copy or electronically transfer the Uniform
Low–Level Radioactive Waste Manifest to the intended consignee so that
either: (1) receipt of the manifest precedes the LLW shipment or (2) the
manifest is delivered to the consignee with the waste at the time the waste is
transferred to the consignee. Using both (1) and (2) is also
acceptable;
4. Include Form 540 (and Form 540A, if required) with the
shipment regardless of the option chosen in paragraph B.3. of this
section;
5. Receive acknowledgment of the receipt of the shipment in
the form of a signed copy of Form 540;
6. Retain a copy of or electronically store the Uniform
Low–Level Radioactive Waste Manifest and documentation of acknowledgment
of receipt as the record of transfer of licensed material as required by
641—subrule 39.4(41);
7. For any shipments or any part of a shipment for which
acknowledgment of receipt has not been received within the times set forth in
this appendix, conduct an investigation in accordance with paragraph E of this
appendix; and
8. Notify the shipper and this agency when any shipment, or
part of a shipment, has not arrived within 60 days after receipt of an advance
manifest, unless notified by the shipper that the shipment has been
canceled.
C. Any licensed waste processor who treats or repackages waste
shall:
1. Acknowledge receipt of the waste from the shipper within
one week of receipt by returning a signed copy of Form 540;
2. Prepare a new manifest that meets the requirements of this
appendix. Preparation of the new manifest reflects that the processor is
responsible for meeting these requirements. For each container of waste in the
shipment, the manifest shall identify the waste generators, the preprocessed
waste volume, and the other information as required in paragraph E.1. of this
appendix;
3. Prepare all wastes so that the waste is classified
according to 10 CFR 61.55 and meets the waste characteristics requirements in 10
CFR 61.56;
4. Label each package of waste to identify whether it is Class
A waste, Class B waste, or Class C waste, in accordance with 10 CFR 61.55 and
61.57;
5. Conduct a quality assurance program to ensure compliance
with 10 CFR 61.55 and 61.56 (the program shall include management evaluation of
audits);
6. Forward a copy or electronically transfer the Uniform
Low–Level Radioactive Waste Manifest to the intended consignee so that
either: (1) receipt of the manifest precedes the LLW shipment or (2) the
manifest is delivered to the consignee with the waste at the time the waste is
transferred to the consignee. Using both (1) and (2) is also
acceptable;
7. Include Form 540 (and Form 540A, if required) with the
shipment regardless of the option chosen in paragraph C.6. of this section;
8. Receive acknowledgment of the receipt of the shipment in
the form of a signed copy of Form 540;
9. Retain a copy of or electronically store the Uniform
Low–Level Radioactive Waste Manifest and documentation of acknowledgment
of receipt as the record of transfer of licensed material as required by
641—subrule 39.4(41);
10. For any shipment or any part of a shipment for which
acknowledgment of receipt has not been received within the times set forth in
this appendix, conduct an investigation in accordance with paragraph E of this
appendix; and
11. Notify the shipper and this agency of any shipment, or
part of a shipment, that has not arrived within 60 days after receipt of an
advance manifest, unless notified by the shipper that the shipment has been
canceled.
D. The land disposal facility operator shall:
1. Acknowledge receipt of the waste within one week of receipt
by returning, as a minimum, a signed copy of Form 540 to the shipper. The
shipper to be notified is the licensee who last possessed the waste and
transferred the waste to the operator. If any discrepancy exists between
materials listed on the Uniform Low–Level Radioactive Waste Manifest and
materials received, copies or electronic transfer of the affected forms must be
returned indicating the discrepancy;
2. Maintain copies of all completed manifests and
electronically store the information required by 10 CFR 61.80(l) until the
license is terminated; and
3. Notify the shipper and this agency when any shipment, or
part of a shipment, has not arrived within 60 days after receipt of an advance
manifest, unless notified by the shipper that the shipment has been
canceled.
E. Any shipment or part of a shipment for which acknowledgment
is not received within the times set forth in this section must:
1. Be investigated by the shipper if the shipper has not
received notification or receipt within 20 days after transfer; and
2. Be traced and reported. The investigation shall include
tracing the shipment and filing a report with this agency. Each licensee who
conducts a trace investigation shall file a written report with this agency
within two weeks of completion of the investigation.
ITEM 37. Amend subrule 41.1(1) as
follows:
41.1(1) Scope. This rule establishes requirements,
for which a registrant is responsible, for use of X–ray equipment by or
under the supervision of an individual authorized by and licensed in accordance
with state statutes to engage in the healing arts or veterinary medicine. The
provisions of this rule are in addition to, and not in substitution for, any
other applicable provisions of these rules. The provisions of Chapter 41 are in
addition to, and not in substitution for, any other applicable portions of
641—Chapters 38 to 42. All references to any Code of Federal Regulations
(CFR) in this chapter are those in effect as of July 1, 1999
May 10, 2000.
ITEM 38. Amend subrule 41.1(2),
introductory paragraph, as follows:
41.1(2) Definitions. For the purpose of this chapter,
the definitions of 641—Chapter Chapters 38 and
40 may also apply. The following are specific to rule
41.1(136C)
641-
Chapter 41.
ITEM 39. Amend subrule 41.1(2) as
follows:
Adopt the following new definitions in
alphabetical order:
“Base density” means the optical density due to
the supporting base of the film alone. The base density of a film is the
optical density that would result if an unexposed film were processed through
the fixer, wash, and dryer, without first passing through the
developer.
“Base plus fog density” means the optical density
of a film due to its base density plus any action of the developer on the
unexposed silver halide crystals. The base plus fog density can be measured by
processing an unexposed film through the entire processing cycle and measuring
the resultant optical density.
“Cassette” means a light–tight case, usually
made of thin, low X–ray absorption plastic, for holding X–ray film.
One or two intensifying screens for the conversion of X–rays to visible
light photons are mounted inside the cassette so that they are in close contact
to the film.
“Control chart” means a chart used to record (and
control) the results of quality control testing as a function of time.
“Control limit” means the range of variation on a
control chart beyond which action must be taken to correct the results of
quality control testing.
“Dedicated mammography equipment” means
X–raysystems designed specifically for breast imaging, providing optimum
imaging geometry, a device for breast compres–sion and low dose exposure
that can generate reproducible images of high quality.
“Densitometer” means an instrument which measures
the degree of blackening (or radiographic density) of film due to radiation or
light by measuring the ratio of the light intensity incident on the film to the
light intensity transmitted by the film.
“Detents” means mechanical settings that limit or
prevent the motion or rotation of an X–ray tube, cassette assembly, or
image receptor system.
“Developer” means a chemical solution (alkaline)
that changes the latent image (exposed silver halide crystals) on a film to a
visible image composed of minute masses of black metallic silver.
“Developer replenishment” means the process,
occurring as film travels past a certain point in the processor, triggering the
activation of a pump, whereby fresh developer is added in small amounts to the
solution in the developer tank of the processor. The purpose is to maintain the
proper alkalinity, chemical activity, and level of solution in the developer
tank.
“Diagnostic mammography” means mammography
performed on an individual who, by virtue of symptoms or physical findings, is
considered to have a substantial likelihood of having breast disease.
“Fixer” means a chemical solution (acidic) which
removes the unexposed and undeveloped silver halide crystals from film so it
will not discolor or darken with age or exposure to light. Fixer also hardens
the gelatin containing the black metallic silver so film may be dried and resist
damage from abrasions.
“Fixer retention” means the inadequate removal of
fixer from the film by the water in the wash tank of the processor. Retained
fixer causes eventual brown discoloration of the radiograph.
“Focal spot size” means the area of the target or
anode that is bombarded by electrons from the cathode of the X–ray tube to
produce X–rays. The smaller the focal spot, the better the limited
spatial resolution of the X–ray system, especially in magnification
mammography.
“Fog” means the density added to a radiograph due
to unwanted action of the developer on the unexposed silver halide crystals or
by light, radiation, chemical, or heat exposure during storage, handling, and
processing.
“Image contrast” means the amount of radiographic
density difference between adjacent areas resulting from a fixed amount of
attenuation difference or light exposure difference.
“Image noise.” See “Radiographic
noise.”
“Image quality” means the overall clarity and
detail of a radiographic image. Limiting spatial resolution (or resolving
power), image sharpness, and image contrast are three common measures of image
quality.
“Image sharpness” means the overall impression of
detail and clarity in a radiographic image.
“Processor” means an automated device which
transports film in a controlled manner by a system of rollers through
specialized sections where developing, fixing, washing, and drying of the film
occur.
“Quality assurance” means the overall program of
testing and maintaining the highest possible standards of quality in the
acquisition and interpretation of radiographic images.
“Quality control” means the actual process of
testing and maintaining the highest possible standards of quality in equipment
performance and the acquisition and interpretation of radiographic
images.
“Radiographic contrast” means the magnitude of
optical density difference between structures of interest and their
surroundings, or between areas of film receiving different amounts of
X–ray or visible light exposure.
“Radiographic noise” means unwanted fluctuations
in optical density on the screen–film image.
“Repeat (or reject) analysis” means a systematic
approach to determine the causes for radiographs being discarded or repeated, or
both.
“Replenishment rate” means the amount of chemicals
added in order to maintain the proper chemical activity of developer and fixer
solutions.
“Safelight” means a source of minimal visible
light in a darkroom, produced at frequencies (colors) to which the film is
insensitive, protecting the film from unwanted exposure (fog) while allowing
personnel to function more efficiently and safely.
“Screen” means microscopic phosphor crystals on a
plastic support and used in conjunction with either single or double emulsion
film; the screen emits visible light when exposed to X–radiation, creating
a latent image on X–ray film.
“Screen–film combination” means a particular
intensifying screen used with a particular type of film. Care must be taken to
match the number of screens (one or two) to the number of emulsions coating the
film and to match the light output spectrum of the screen to the light
sensitivity of the film.
“Screen–film contact” means the close
proximity of the intensifying screen to the emulsion of the film, necessary in
order to achieve a sharp image on the film.
“Sensitometer” means a device used to reproducibly
expose a piece of film to a number of different levels of light
intensity.
“Sensitometric strip” means a sheet of film
exposed by a sensitometer, resulting in a gray scale range. Such strips are
used to measure the range of densities, from minimum to maximum, resulting from
a reproducible set of exposures.
“Sensitometry” means a quantitative measurement of
the response of film to exposure and development. Sensitometry is used to test
the processor setup and stability.
“Viewbox” means a device by which a uniform field
of white light is transmitted through an X–ray so that the image on the
film may be seen.
Amend the following definition:
“X–ray exposure control” means a
device, switch, button or similar means by which an operator initiates or
terminates the radiation exposure. The X–ray exposure control may include
such associated equipment as timers and backup timers.
ITEM 40. Amend subrule 41.1(2) by
rescinding the following definitions: “barrier,”
“beam–limiting device,” “detector,”
“kV,” “lead equivalent,” “leakage
radiation,” “light field,” “mA,” “primary
protective barrier,” “protective barrier,” “radiation
detector,” “secondary protective barrier,”
“shutter,” “SSD,” “stray radiation,”
“termination of irradiation,” and “tube housing
assembly.”
ITEM 41. Amend subparagraph
41.1(3)“a”(6) as follows:
(6) Gonad shielding of not less than 0.25
0.50 millimeter lead equivalent shall be used for human patients, who
have not passed the reproductive age, during radiographic procedures in which
the gonads are in the useful beam, except for cases in which this would
interfere with the diagnostic procedure.
ITEM 42. Amend
41.1(3)“f”(1)“2” as follows:
2. The temperature of solutions in the tanks shall be
maintained within the range of 60°F to
80°F (16°C to
27°C). Film shall be developed in accordance
with the time–temperature relationships recommended by the film
manufacturer or, in the absence of such recommendations, with the
time–temperature chart available from the agency.
ITEM 43. Amend
41.1(3)“f”(2)“1” as follows:
1. Films shall be developed in accordance with the
time–temperature relationships recommended by the film
manu–facturer; in the absence of such recommendations, the film
shall be developed using the chart available from the agency.
ITEM 44. Amend paragraph
41.1(3)“f” by adopting new subparagraph
(4) as follows:
(4) Records shall be maintained to verify that the itemsin
41.1(3)“f” are performed according to the requirements. Records may
be discarded only after an agency inspection has been completed and the facility
determined to be in compliance.
ITEM 45. Amend paragraph
41.1(4)“i” as follows:
i. Locks. All position locking, holding, and
centering devices on X–ray system components and systems shall function as
intended. All X–ray systems shall be maintained in good mechanical
repair and comply with all state and local electrical code
requirements.
ITEM 46. Amend subrule 41.1(6),
catchwords, as follows:
41.1(6) Radiographic systems, including
veterinary, other than fluoroscopic, dental intraoral, or computed
tomography X–ray systems.
ITEM 47. Rescind
41.1(6)“h”(1)“3.”
ITEM 48. Amend subparagraph
41.1(7)“c”(5) as follows:
(5) Each X–ray exposure switch shall be located in such
a way as to meet the following requirements:
1. Stationary X–ray systems shall be required to
have the X–ray exposure switch so that the operator is required to remain
in the protected area during the entire exposure; and Stationary
X–ray systems shall be required to have the X–ray exposure switch
located in a protected area or have an exposure switch cord of sufficient length
to permit the operator to activate the unit while in a protected area, e.g.,
corridor outside the operatory. The procedures required under
41.1(3)“a”(4) must instruct the operator to remain in the protected
area during the entire exposure.
2. Mobile and portable X–ray systems which
are:
• Used for greater than one
week in the same location, i.e., a room or suite, shall meet the requirements of
41.1(7)“c”(5)“1.”
• Used for greater than one
hour and less than one week at the same location, i.e., a room or suite, shall
meet the requirements of the above paragraph or be provided with a 6.5 foot
(1.98 m) high protective barrier or means to allow the operator to be at least 9
feet (2.7 meters) from the tube housing assembly while making
exposure.
ITEM 49. Amend subrule 41.1(9) by
adopting the following new paragraphs:
e. Bone densitometry on human patients shall be conducted only
under a prescription of a licensed physician, a licensed physician assistant as
defined in Iowa Code section 148C.1, subsection 6, or a licensed registered
nurse who is registered as an advanced registered nurse practitioner pursuant to
Iowa Code chapter 152.
f. During the operation of the bone densitometry
system:
(1) The operator, ancillary personnel, and members of the
general public shall be positioned at least one meter from the patient and bone
densitometry system during the examination.
(2) The operator shall advise the patient that the bone
densitometry examination is a type of X–ray procedure.
g. Equipment shall be maintained and operated in accordance
with the manufacturer’s specifications. Records of the maintenance shall
be kept for inspection by the agency.
ITEM 50. Amend subrule 41.1(11),
paragraph “a,” introductory paragraph, as follows:
a. Definitions. In addition to the definitions provided in
641—38.2(136C),
641-40.2(136C), and 41.1(2), the
following definitions shall be applicable to 41.1(11):
ITEM 51. Amend subrule 41.2(14),
paragraph “c,” as follows:
c. When a misadministration involves a diagnostic procedure,
the radiation safety officer shall promptly investigate its cause, make a record
for agency review, and retain the record as directed in 41.2(14)“d.”
The licensee shall also notify the referring physician and the agency in writing
on IDPH Form #588–2608 or equivalent within 15 days if the
misadministration involved the use of radioactive material not intended for
medical use, administration of dosage five–fold different from the
intended dosage, or administration of radioactive material such that the patient
or human research subject is likely to receive an organ dose greater
than 2 rems (0.02 Sv) or a whole body dose greater than 500 millirems (5
mSv) a dose exceeding 5 rem (0.05 Sv) effective dose equivalent or
50 rem (0.5 Sv) dose equivalent to any individual organ. Licensees may use
dosimetry tables in package inserts, corrected only for amount of radioactivity
administered, to determine whether a report is required.
ITEM 52. Amend subparagraph
41.2(60)“a”(2), numbered paragraphs “1”
and “2,” as follows:
1. Radiation levels dose rates in
restricted areas are not likely to cause personnel exposures
any occupationallyexposed individual to receive a dose in excess of the
limits specified in 641—40.15(136C); and
2. Radiation levels dose rates in
controlled or unrestricted areas do not exceed are
not likely to cause any individual member of the public to receive a dose in
excess of the limits specified in 641—40.26(136C).
ITEM 53. Amend subrule 41.2(62),
introductory paragraph, as follows:
41.2(62) Modification of teletherapy unit or room
before beginning a treatment program. If the survey required by 41.2(60)
indicates that an individual in an unrestricted area may be exposed to
levels of radiation any individual member of the public is likely to
receive a dose greater than those permitted by 641—40.26(136C) before
beginning the treatment program the licensee shall:
ITEM 54. Amend subrule 41.3(1),
paragraph “b,” as follows:
b. The use of therapeutic radiation machines shall beby, or
under the supervision of, a physician who meets the training/experience criteria
established by 41.3(4)“c.”
41.3(5).
ITEM 55. Amend subrule 41.3(2),
introductory paragraph, as follows:
41.3(2) Definitions. In addition to the
definitions provided in 641-38.2(136C)
and 641-40.2(136C),
The the following definitions are specific to
641—41.3(136C).
ITEM 56. Amend subrule 41.3(2) by
rescinding the following definitions: “beam axis,” “kilo
electron volt (keV),” “radiation detector,” and
“target–to–skin distance (TSD).”
ITEM 57. Amend subrule 41.3(2),
definition of “filter,” as follows:
“Filter” means material placed in the useful beam
to change beam quality in therapeutic radiation machines subject to
subrule 41.3(6).
ITEM 58. Amend subrule 41.3(12) as
follows:
41.3(12) Records retention. All records required by
641—41.3(136C) shall be retained until disposal is authorized by the
agency unless another retention period is specifically authorized in 41.3(136C).
All required records shall be retained in an active file from at least the
time of generation until the next agency inspection. Any required record
generated before the last agency inspection may be microfilmed or otherwise
archived as long as a complete copy can be retrieved until such time the agency
authorizes final disposal.
ITEM 59. Rescind and reserve subrule
41.3(13).
ITEM 60. Amend subparagraph
41.3(17)“a”(1) by adopting new numbered
paragraph “3” as follows:
3. For each therapeutic machine, the registrant shall
determine, or obtain from the manufacturer, the leakage radiation existing at
positions specified in 41.3(17)“a”(1)“1” and
41.3(17)“a”(1)“2” for the specified operating
conditions. Records on leakage radiation measurements shall be maintained at
the facility for inspection by the agency.
ITEM 61. Amend subparagraph
41.3(18)“a”(15) as follows:
(15) Selection of energy. Equipment capable of generating
radiation beams of different energies shall meet the following
requirements:
1. Irradiation shall not be possible until a selection of
energy has been made at the treatment control panel;
2. The nominal energy value selected shall be displayed at the
treatment control panel before and during irradiation; until
reset manually for the next irradiation. After termination of irradiation, it
shall be necessary to reset the nominal energy value selected before subsequent
treatment can be initiated; and
3. Irradiation shall not be possible until the appropriate
flattening filter or scattering foil for the selected energy is in its proper
location.
ITEM 62. Amend subrule 41.3(18) as
follows:
Amend paragraph “e” as follows:
e. Full calibration measurements.
(1) Full calibration of a therapeutic radiation machine
subject to 41.3(18) shall be performed by, or under the direct supervision of, a
radiation therapy physicist:
1. Before the first medical use following installation or
reinstallation of the therapeutic radiation machine;
2. At intervals not to exceed 12 months;
and
2. Full calibration shall include measurement of all
parameters listed in Appendix D of
641-Chapter 41. Although it shall not
be necessary to complete all elements of a full calibration at the same time,
all parameters (for all energies) shall be completed at intervals not to exceed
12 calendar months, unless a more frequent interval is required by this
agency.
3. No change.
4. Notwithstanding the requirements of
41.3(18)“e”(1)“3”:
• Full
calibration of therapeutic radiation machines with multienergy or multimode
capabilities is required only for those modes or energies that are not within
their acceptable range; and
• If
the repair, replacement or modification does not affect all modes or energies,
full calibration shall be performed on the effected mode/energy that is in most
frequent clinical use at the facility. The remaining energies/modes may be
validated with quality assurance check procedures against the criteria in
41.3(18)“e”(1)“3.”
(2) To satisfy the requirement of
41.3(18)“e”(1), full calibration shall include all measurements
required for annual calibration by Appendix D of 641—Chapter
41.
(3) (2) The registrant shall use the
dosimetry system described in 41.3(16)“c” to measure the radiation
output for one set of exposure conditions. The remaining radiation
measurements required in 41.3(18)“e”(2) may then be
made using a dosimetry system that indicates relative dose rates;
and
(4) (3) The registrant
shall maintain a record of each calibration for the duration of the
registration. The record shall include the date of the calibration, the
manufacturer’s name, model number, and serial number for the therapeutic
radiation machine, the model numbers and serial numbers of the instruments used
to calibrate the therapeutic radiation machine, and the signature of the
radiation therapy physicist responsible for performing the
calibration.
Amend paragraph “f,” subparagraphs
(1) and (3), as follows:
(1) Periodic quality assurance checks shall be performed on
all therapeutic radiation machines subject to 41.3(18) at intervals not
to exceed one week; as specified in Appendix D of
641-Chapter 41;
(3) The registrant shall use a dosimetry system which has been
compared intercompared within the previous 12 months
with the dosimetry system described in 41.3(16)“c”(1) to make the
periodic quality assurance checks required in
41.3(18)“f”(2);
ITEM 63. Amend subrule 41.6(1),
introductory paragraph, as follows:
41.6(1) Definitions. In addition to the definitions
provided in 641-38.2(136C),
641-40.2(136C), and
641- 41.1(136C), the following
definitions shall be applicable to this rule.
ITEM 64. Amend subrule 41.6(1) by
rescinding the following definitions: “base density,” “base
plus fog density,” “cassette,” “control chart,”
“control limit,” “densitometer,” “detents,”
“developer,” “developer replenishment,”
“diagnostic mammography,” “fixer,” “fixer
retention,” “focal spot size,” “fog,”
“half–value layer (HVL),” “image contrast,”
“image quality,” “image sharpness,” “kilovoltage
peak (kVp),” “milliampere (mA) setting,” “milliampere
seconds (mAs),” “phantom,” “physician consultant,”
“processor,” “quality assurance,” “quality
control,” “quality control technologist,” “radiographic
contrast,” “radiographic noise,” “radiographic
sharpness,” “repeat (or reject) analysis,”
“replenishment rate,” “safelight,” “screen,”
“screen–film combination,” “screen–film
contact,” “sensitometer,” “sensitometric strip,”
“sensitometry,” “thermoluminescent dosimeter (TLD),” and
“viewbox.”
ITEM 65. Amend subrule 41.6(1) by
adopting the following new definitions in alphabetical
order:
“Category 1” means medical education activities
that have been designated as Category 1 by the Accreditation Council for
Continuing Medical Education (ACCME), the American Osteopathic Association
(AOA), a state medical society, or an equivalent organization.
“MQSA” means the Mammography Quality Standards Act
of 1992.
“Positive mammogram” means a mammogram that has an
overall assessment of findings that are either “suspicious” or
“highly suggestive” of malignancy.
“Serious complaint” means a report of a serious
adverse event. This means an event that may significantly compromise clinical
outcomes, or an adverse event for which a facility fails to take appropriate
corrective action in a timely manner.
ITEM 66. Amend subrule 41.6(2),
paragraph “a,” by adopting the following new
subparagraph (8):
(8) Provisional authorization. A new facility beginning
operation after September 30, 1994, is eligible to apply for a provisional
authorization. This will enable the facility to perform mammography and to
obtain the clinical images needed to complete the authorization process. To
apply for and receive a provisional certificate, a facility must meet the
requirements of 641-41.6(136C). A provisional
authorization shall be effective for up to six months from the date of issuance
and cannot be renewed. The facility may apply for a 90–day
extension.
ITEM 67. Amend subrule 41.6(2),
paragraph “c,” as follows:
c. Withdrawal or denial of mammography
authorization.
(1) Mammography authorization may be withdrawn with cause if
any facility or machine does not meet one or more of the standards of
these rules, will not permit inspections or provide access to records or
information in a timely fashion, or has been guilty of misrepresentation in
obtaining the authorization.
(2) The facility shall have opportunity for a hearing in
connection with a denial or withdrawal of mammography authorization in
accordance with 641-Chapter
173.
(3) An emergency order withdrawing authorization may be issued
in accordance with 641-173.31(17A)
if the agency finds the radiation unit or facility violates rules that
seriously affect the health, safety, and welfare of the public. An opportunity
for hearing shall be held within five working days after the issuance of the
order. The order shall be effective during the proceedings.
(4) If authorization is withdrawn, the radiation machine shall
not be used for mammography until reinstated.
(5) If a facility’s authorization is revoked, no
person who owned or operated that facility at the time the act occurred may own
or operate a mammography facility within two years of the date of
revocation.
ITEM 68. Amend subrule 41.6(3) as
follows:
41.6(3) Mammography personnel.
a. Physician consultant.
(1) Must be available either on staff or through
arrangement.
(2) Must document in writing annually completion
of:
1. Review of the procedural manuals to determine that
they are adequate.
2. Verification that equipment and personnel meet
applicable state requirements and are performing properly.
3. Verification that the safety procedures are being
followed.
4. Verification that all other requirements of these
rules are being met.
a. Reserved.
b. Interpreting physician. All mammograms must be
interpreted by a radiologist who meets All radiologists qualifying
before October 1, 1994, must meet the requirements in effect as of October 1,
1994. All radiologists qualifying after April 28, 1999, must meet MQSA rules
effective on that date or meet the following certification, experience,
continuing education, and written report requirements:
(1) Be certified in diagnostic radiography by the
American Board of Radiology, the American Osteopathic Board of Radiology, or
Royal College of Physicians and Surgeons of Canada in Radiology or have had at
least two three months of documented full–time
mammographic training from a person recognized by this agency. The
training must include interpretation of mammograms and topics in
mammography, including instructions in radiation physics specific to
mammography, radiation effects and radiation protection. Mammography
interpretation shall be under the direct supervision of a physician who already
meets the requirements as an interpreting physician.
(2) Has interpreted or multi–read an average of
ten or more mammograms per workweek in the prior six months
960 mammograms in the prior 24 months or has completed a radiology
residency within the past two years. The multi–reading shall be under
the direct supervision of an interpreting physician who meets the qualifications
of these rules.
(3) Has successfully completed or taught a minimum of
40 60 hours (includes radiology residency) of
postgraduate instruction in mammography interpretation, basic breast anatomy,
pathology, physiology, technical aspects of mammography, and quality assurance
and quality control in mammography. All 60 of these hours shall be Category 1
and at least 16 of the Category 1 hours shall have been acquired within the last
36 months immediately prior to the date that the physician qualifies as an
interpreting physician. Before beginning to independently interpret
mammograms produced by a new mammographic modality in which the interpreting
physician has not previously been trained, the interpreting physician shall have
at least 8 hours of training in the new mammographic modality.
(4) Has successfully completed or taught a minimum of 15
Category 1 hours of postgraduate instruction in
mammography interpretation every 36 months thereafter. This
training shall include at least 6 Category 1 continuing medical education
credits in each mammographic modality used by the interpreting physician in
practice. Credits earned through teaching a specific course can be counted only
once towards the 15 required even if the course is taught multiple times during
the previous 36 months.
(5) Continues to interpret or multi–read
an average of ten or more mammograms per workweek 960
mammograms in 24 months.
(6) and (7) No change.
(8) Provides a written statement to the patient, either
through a referring physician or designee or, if a referring physician is not
available, directly to the patient. The statement must:
1. to 3. No change.
4. Indicate that the original images of films are being
provided to the mammographic supplier facility, for
inclusion in the patient’s medical record.
(9) Reestablishing qualifications.
1. Interpreting physicians who fail to maintain the
required continuing interpreting experience or continuing education requirements
of 41.6(3)“b”(5) shall reestablish their qualifications before
resuming the independent interpretation of mammograms by:
• Interpreting or
multi–reading at least 240 mammographic examinations under the direct
supervision of an interpreting physician who meets the qualifications of these
rules, or
• Interpreting or
multi–reading a sufficient number of mammographic examinations, under the
direct supervision of an interpreting physician who meets the qualifications of
these rules, to bring the physician’s total up to 960 examinations for the
prior 24 months, whichever is less.
2. The interpretations required shall be done within the 6
months immediately prior to resuming independent interpretation.
3. Interpreting physicians who fail to meet the continuing
education requirements of 41.6(3)“b”(4) shall obtain a sufficient
number of additional Category 1 continuing medical education credits in
mammography to bring their total up to the required 15 credits in the previous
36 months before resuming independent interpretation.
c. Mammography imaging medical physicist. All mammography
imaging medical physicists conducting surveys of mammography facilities and
providing oversight of the facility quality assurance program under the federal
Mammography Quality Standards Act of 1992 (MQSA) shall meet the requirements for
initial qualifications as well as the requirements for continuing
qualifications.
(1) Initial qualifications. All mammography imaging medical
physicists shall be state–approved or and be
certified in diagnostic radiation physics or radiation physics bythe
American Board of Radiology in Radiological Physics/Diagnostic Radiological
Physics, the American Board of Medical Physics in Diagnostic Imaging Physics, or
the Canadian College of Physicists in Medicine as a Fellow in Diagnostic
Radiological Physics or any other body approved by FDA to certify medical
physicists; and
1. Have a master’s or higher degree in a physical
science from a college or university accredited by one of the regional
accreditation bodies of the Commission on Higher Education with not less than
30 20 semester hours or 30 quarter hours or
equivalent of college level physics or radiation science, have two years
of experience in conducting performance evaluations of mammography
facilities, have experience in conducting surveys of at least one
mammography facility and a total of at least ten mammography units (no more than
one survey of a specific unit within a period of 60 days can be counted towards
this requirement), and 20 contact hours of documented specialized
training in conducting performance evaluations of mammography facilities.
Complete surveys of five mammography units shall be equal to one year of
experience. Two or more years of training while pursuing a master’s or
higher degree in medical physics may be accepted in lieu of one year of
experience. After April 28, 1999, the experience shall be acquired
under the direct supervision of a mammography imaging medical physicist who
meets the requirements in 41.6(3)“c”(1) and
41.6(3)“c”(2). , or
2. Prior to October 27, 1997, have a bachelor’s
degree in a physical science from a college or university accredited by one of
the regional accreditation bodies of the Commission on Higher Education with not
less than 15 semester hours or equivalent college level physics or radiation
sciences and five years of experience in conducting performance evaluations of
mammography facilities. The individual shall have surveyed at least five
mammography units in each of the five years and have at least 40 hours of
documented specialized training in conducting performance evaluations of
mammography facilities to comply with the requirements of
MQSA.
2. Have a letter of approval from the FDA.
3. Before a medical physicist may begin independently
performing mammographic surveys of a new mammographic modality other than one
for which the physicist received initial training, the physicist must receive at
least 8 hours of training in surveying units of the new mammographic
modality.
4. Apply and receive approval from this
agency.
(2) Continuing qualifications.
1. Continuing education. After the third anniversary of
completion of the requirements of 41.6(3)“c”(1), the individual
shall have taught or completed at least 15 continuing education units in
mammographic imaging over the three previous years previous
36 months. This shall include training, if available, appropriate to each
mammographic modality evaluated by the mammography imaging medical physicist
during the surveys or oversights of quality assurance programs for which the
medical physicist is responsible. Units earned through teaching a specific
course can be counted only once towards the required 15 units in a
36–month period, even if the course is taught multiple times during the
36–month period.
2. Continuing experience. After the first anniversary of
completion of the requirements of 41.6(3)“c”(1), and each year
thereafter, the individual shall have surveyed at least three Iowa
mammography units facilities within the last 12
months. No more than one survey of a specific facility within a
10–month period or a specific unit within a period of 60 days can be
counted towards the total mammography unit survey requirement. This
requirement does not apply to an individual who is employed full–time at a
single facility as a diagnostic medical physicist.
(3) and (4) No change.
(5) Mammography imaging medical physicists who fail to
maintain the required continuing qualifications stated in
41.6(3)“c”(2) shall reestablish their qualifications before
independently surveying another facility. To reestablish their qualifications,
mammography imaging medical physicists who fail to meet the continuing education
requirement of 41.6(3)“c”(2) must obtain a sufficient number of
continuing education units to bring their total up to the required 15 in the
previous three years. Mammography imaging medical physicists who fail to meet
the continuing experience requirement of 41.6(3)“c”(1) must obtain
experience by surveying one mammography unit for each year of not meeting the
continuing experience requirements under the supervision of a mammography
imaging medical physicist who meets the qualifications stated in
41.6(3)“c”(1) and 41.6(3)“c”(2). After five years of
not meeting the continuing experience requirements, the mammography imaging
medical physicist must requalify under
41.6(3)“c”(1).
(5) Reestablishing qualifications. Medical physicists who
fail to maintain the required continuing qualifications of this subrule shall
obtain a sufficient number of continuing education units to bring their total
units up to the required 15 in the previous 36 months. Those failing to meet
the continuing experience requirements of this subrule must complete a
sufficient number of surveys under the direct supervision of a medical physicist
who meets the qualifications of this subrule to bring the total surveys up to
the required three Iowa facilities in the previous 12 months. No more than one
survey of a specific unit within a period of 60 days can be counted towards the
total mammography unit survey requirement.
d. Equipment operators. Any individual operating mammography
equipment must be a physician as defined in 641—Chapter 38 or must
be credentialed as a general radiographer as set forth in
641—Chapter 42.
(1) Each general radiographer must meet one of the
following:
1. No change.
2. Have successfully completed a formal training program in
radiologic technology that is approved by the Council on Allied Health
Education and Accreditation Joint Review Committee on Education on
Radiologic Technology; or
3. No change.
(2) Each general radiographer must have completed successfully
40 hours of specialized training, approved by the agency, to include a minimum
of one hour of hands–on mammographic positioning
compression, quality assurance/control, technique factor settings,
imaging of patients with breast implants, and other areas pertinent to
mammography prior to the time the individual begins performing mammography.
and an average of five hours of specialized training every 12 months
thereafter to be averaged over no more than a 36–month period.
Training shall include the performance of a minimum of 25 examinations under the
direct supervision of an individual already qualified under this subrule and at
least 8 hours of training in each mammography modality to be used by the
technologist in performing mammography examinations.
Training programs shall be submitted to the agency for
approval and shall include demonstrations and practical evaluation by the
instructor of the student’s performance and documentation describing
training, date and length of training, and evaluation of student’s
performance to be signed and dated by the instructor, and the business address
of the supplier of the training.
(3) Continuing education. Each general radiographer shall
have completed or taught an average of 5 hours of specialized mammographic
training every 12 months thereafter to be averaged over no more than a
36–month period. Units earned through teaching a specific course can be
counted only once towards the 15 required hours even if the course is taught
multiple times during the previous 36 months to a maximum of 7.5 hours.
Beginning April 28, 1999, at least 6 of the continuing education hours shall be
related to each mammographic modality used by the radiographer.
(4) Beginning April 28, 1999, each general radiographer
shall have performed a minimum of 200 mammography examinations during each
24–month period thereafter.
(5) Requalification.
1. General radiographers who fail to meet the continuing
education requirements of this subrule shall obtain a sufficient number of
continuing education hours in mammography to bring their total up to at least 15
in the previous 36 months, at least 6 of which shall be related to each modality
used by the radiographer. The general radiographer may not resume performing
unsupervised mammography examinations until the continuing education
requirements are completed.
2. General radiographers who fail to meet the continuing
experience requirements of this subrule shall perform a minimum of 25
mammography examinations under the direct supervision of a qualified radiologic
technologist before resuming the performance of unsupervised mammography
examinations.
(6) Before a general radiographer may begin independently
performing mammographic examinations using a mammographic modality other than
the one for which the radiographer received training under this subrule, the
radiographer shall have at least 8 hours of continuing education hours in the
new modality.
e. No change.
f. Personnel records. Records must be maintained to indicate
that each employee is qualified for a specific position by means of appropriate
state or other certification, license, training, and experience. Records of
personnel no longer employed by the facility should not be discarded until the
next annual inspection has been completed and it has been determined that the
facility is in compliance.
ITEM 69. Amend subrule 41.6(4) as
follows:
41.6(4) Obtaining and preserving records.
a. No change.
b. The supplier must make, for each patient, a record of the
mammography services it provides, including:
(1) The date the mammography procedure was performed,
and the date of the interpretation, and the name of the
interpreting physician.
(2) The name of the patient and an additional patient
identifier.
(3) The name of the operator of the equipment and the
interpreting physician.
(4) to (6) No change.
(7) The overall final assessment of findings, classified in
one of the following categories:
1. “Negative”: Nothing to comment upon (if the
interpreting physician is aware of clinical findings or symptoms, despite the
negative assessment, these shall be explained).
2. “Benign”: Also a negative
assessment.
3. “Probably benign”: Finding(s) has a high
probability of being benign.
4. “Suspicious”: Finding(s) without all the
characteristic morphology of breast cancer but indicating a definite probability
of being malignant.
5. “Highly suggestive of malignancy”:
Finding(s) has a high probability of being malignant.
(8) In cases where no final assessment category can be
assigned due to incomplete work–up, “Incomplete: Need additional
imaging evaluation” shall be assigned as an assessment, and reasons why no
assessment can be made shall be stated by the interpreting
physician.
(9) Recommendations made to the health care provider about
what additional actions, if any, should be taken. All clinical questions raised
by the referring health care provider shall be addressed in the report to the
extent possible, even if the assessment is negative or benign.
c. Preservation of records.
(1) and (2) No change.
(3) If the supplier should cease to exist before the end of
the 60–month period, the records must be transferred to the patient or
patient’s physician or other mammographic facility.
(4) The supplier shall upon request by, or on behalf of,
the patient, permanently or temporarily, transfer the original mammograms and
copies of the patient’s reports to a medical institution, or to a
physician or health care provider of the patient, or to the patient
directly.
(5) Any fee charged to the patients for providing the
services in subparagraph (4) above shall not exceed the documented costs
associated with this service.
d. Communication of results to the patient. Each facility
shall maintain a system to ensure that the results of each mammographic
examination are communicated to the patient in a timely manner. If assessments
are “Suspicious” or “Highly suggestive of malignancy”
and the patient has not named a health care provider, the facility shall make
reasonable attempts to ensure that the results are communicated to the patient
as soon as possible.
(1) As soon as possible, but no later than 30 days from the
date of the mammography examination, patients who do not name a health care
provider to receive the mammography report shall be sent the report described in
41.6(4)“e”(1) in addition to a written notification of results in
lay terms.
(2) Each facility that accepts patients who do not have a
primary care provider shall maintain a system for referring such patients to a
health care provider when clinically indicated.
e. Communication of results to health care providers. When
the patient has a referring health care provider or the patient has named a
health care provider, the facility shall:
(1) Provide a written report of the mammography
examination, including the items listed in 41.6(4)“b”(7), to the
health care provider as soon as possible, but no later than 30 days from the
date of the examination, and
(2) If the assessment is “Suspicious” or
“Highly suggestive of malignancy,” make reasonable attempts to
communicate with the health care provider as soon as possible or, if the health
care provider is unavailable, to a responsible des–ignee of the health
care provider.
f. Mammographic image identification. Each mammographic
image shall have the following information indicated on it in a permanent,
legible, and unambiguous manner and placed so as not to obscure anatomic
structures:
(1) Name of patient and an additional patient
identifier.
(2) Date of examination.
(3) View and laterality. This information shall be placed
on the image in a position near the axilla. Standardized codes specified by the
accreditation body and approved by FDA shall be used to identify view and
laterality.
(4) Facility name and location. At a minimum, the location
shall include the city, state, and ZIP code of the facility.
(5) Technologist identification.
(6) Cassette/screen identification.
(7) Mammography unit identification, if there is more than
one unit in the facility.
ITEM 70. Amend subrule 41.6(5),
paragraphs “a” and “c,” as
follows:
a. The supplier shall ensure that the facility has an
equipment quality assurance program specific to mammography and covering all
components of the system, to ensure consistently
high–quality images with minimum patient exposure. Responsibility for
the quality assurance program and for each of its elements shall be assigned to
individuals who are qualified for their assignments and who shall be allowed
adequate time to perform these duties.
(1) Lead interpreting physician. The facility shall
identify a lead interpreting physician who shall have the general responsibility
of ensuring that the quality assurance program meets all requirements of these
rules. No other individual shall be assigned or shall retain responsibility for
quality assurance tasks unless the lead interpreting physician has determined
that the individual’s qualifications for, and performance of, the
assignment are adequate.
(2) Interpreting physicians. All interpreting physicians
interpreting mammograms for the facility shall:
1. Follow the facility procedures for corrective action
when the images they are asked to interpret are of poor quality,
and
2. Participate in the facility’s medical outcomes
audit program.
(3) Medical physicist. Each facility shall have the
services of a medical physicist available to survey mammography equipment and
oversee the equipment–related quality assurance practices of the facility.
At a minimum, the medical physicist(s) shall be responsible for performing the
surveys and mammography equipment evaluations and providing the facility with
the applicable reports.
(4) Quality control technologist. Responsibility for all
individual tasks within the quality assurance program not assigned to the lead
interpreting physician or the medical physicist shall be assigned to a quality
control technologist(s). The tasks are to be performed by the quality control
technologist or by other personnel qualified to perform the tasks. When other
personnel are utilized for these tasks, the quality control technologist shall
ensure that the tasks are completed in such a way as to meet the requirements of
41.6(5)“e” through “k.”
c. Under the direction of the lead interpreting
physician consultant, the radiation physicist shall have
responsibility for establishing and conducting the equipment quality assurance
program. The program shall include:
(1) to (3) No change.
ITEM 71. Amend subrule 41.6(5),
paragraph “h,” as follows:
h. Retake analysis program.
(1) A program shall be established as a further aid in
detecting and correcting problems affecting image quality or exposure.
(2) All retakes shall be logged including date,
technologist’s name and reason for retake. A retake analysis shall be
performed every 250 patients or quarterly, whichever comes first.
(3) If the total repeat or reject rate changes from the
previously determined rate by more than 2.0 percent of the total films included
in the analysis, the reason(s) for the change shall be determined. Any
corrective actions shall be recorded and the results of these corrective actions
shall be assessed.
ITEM 72. Amend subrule 41.6(5) as
follows:
Amend paragraph “i” as follows:
i. Medical outcomes audit. Each facility shall establish a
system for reviewing outcome data from all mammography performed, including
follow–up on the disposition of positive mammograms and correlation of
surgical biopsy results with mammogram reports the
interpreting physician’s findings. This program shall be designed
to ensure the reliability, clarity, and accuracy of the interpretation of
mammograms.
(1) Analysis of these outcome data shall be made
individually and collectively for all interpreting physicians at the facility.
In addition, any cases of breast cancer among women imaged at the facility that
subsequently become known to the facility shall prompt the facility to
initiatefollow–up on surgical or pathology results, or both, and review of
the mammograms taken prior to the diagnosis of a malignancy. Responsibility for
each requirement for monitoring shall be assigned to qualified personnel and
documented in the supplier’s records.
(2) Frequency of audit analysis. The facility’s
first audit analysis shall be initiated no later than 12 months after the date
the facility becomes certified, or 12 months after April 28, 1999, whichever
date is the latest. This audit analysis shall be completed within an additional
12 months to permit completion of diagnostic procedures and data collection.
Subsequent audit analyses will be conducted at least once every 12
months.
(3) Reviewing interpreting physician. Each facility shall
designate at least one interpreting physician to review the medical outcomes
audit data at least once every 12 months. This individual shall record the
dates of the audit period(s) and shall be responsible for analyzing results
based on this audit. This individual shall also be responsible for documenting
the results, notifying other interpreting physicians of their results and the
facility aggregate results. If follow–up actions are taken, the reviewing
interpreting physician shall also be responsible for documenting the nature of
the follow–up.
Rescind paragraph “j” and adopt the
following new paragraph in lieu thereof:
j. Quality assurance records. The lead interpreting
physician, quality control technologist, and medical physicist shall ensure that
records concerning employee qualifications to meet assigned quality assurance
tasks, mammography technique and procedures, quality control (including
monitoring data, problems detected by analysis of that data, corrective actions,
and the effectiveness of the corrective actions), safety, and protection are
properly maintained and updated. These quality control records shall be kept
for each test specified in these rules until the next annual inspection has been
completed and the facility is in compliance with the quality assurance
requirements or until the test has been performed two additional times at the
required frequency, whichever is longer.
Adopt new paragraphs “k” to
“o” as follows:
k. Quality assurance—equipment.
(1) Daily quality control tests. Film processors used to
develop mammograms shall be adjusted and maintained to meet the technical
development specifications for the mammography film in use. A processor
performance test shall be performed on each day that examinations are performed
before any clinical films are processed that day. The test shall include an
assessment of base plus fog density, mid–density, and density difference,
using the mammography film used clinically at the facility.
1. The base plus fog density shall be within plus or minus
0.03 of the established operating level.
2. The mid–density shall be within plus or minus 0.15 of
the established operating level.
3. The density difference shall be within plus or minus 0.15
of the established operating level.
(2) Weekly quality control tests. Facilities with
screen–film systems shall perform an image quality evaluation test, using
an FDA–approved phantom, at least weekly.
1. The optical density of the film at the center of an image
of a standard FDA–accepted phantom shall be at least 1.20 when exposed
under a typical clinical condition.
2. The optical density of the film at the center of the
phantom image shall not change by more than plus or minus 0.20 from the
established operating level.
3. The phantom image shall achieve at least the minimum score
established by the accreditation body and accepted by FDA.
4. The density difference between the background of the
phantom and an added test object used to assess image contrast shall be measured
and shall not vary by more than plus or minus 0.05 from the established
operating level.
(3) Quarterly quality control tests. Facilities with
screen–film systems shall perform the following quality control tests at
least quarterly:
• Fixer
retention in film. The residual fixer shall be no more than 5 micrograms per
square centimeter.
(4) Semiannual quality control tests. Facilities with
screen–film systems shall perform the following quality control tests at
least semiannually:
1. Darkroom fog. The optical density attributable to darkroom
fog shall not exceed 0.05 when a mammography film of the type used in the
facility, which has a mid–density of no less than 1.2 OD, is exposed to
typical darkroom conditions for two minutes while such film is placed on the
countertop emulsion side up. If the darkroom has a safelight used for
mammography film, it shall be on during this test.
2. Screen–film contact. Testing for screen–film
contact shall be conducted using 40 mesh copper screen. All cassettes used in
the facility for mammography shall be tested.
3. Compression device performance. A compression force of at
least 25 pounds (111 newtons) for 15 seconds shall be provided. Effective
October 28, 2002, the maximum compression force for the initial power drive
shall be between 25 pounds (111 newtons) and 47 pounds (209 newtons).
(5) Annual quality control tests. Facilities with
screen–film systems shall perform the following quality control tests at
least annually:
1. Automatic exposure control (AEC) performance.
• The AEC shall be capable of
maintaining film optical density within plus or minus 0.30 of the mean optical
density when thickness of a homogeneous material is varied over a range of 2 to
6 centimeters and the kVp is varied appropriately for such thicknesses over the
kVp range used clinically in the facility. If this requirement cannot be met, a
technique chart shall be developed showing appropriate techniques (kVp and
density control settings) for different breast thicknesses and compositions that
must be used so that optical densities within plus or minus 0.30 of the average
under phototimed conditions can be produced.
• After October 28, 2002, the
AEC shall be capable of maintaining film optical density (OD) within plus or
minus 0.15 of the mean optical density when thickness of a homogenous material
is varied over a range of 2 to 6 centimeters and the kVp is varied appropriately
for such thicknesses over the kVp range used clinically in the
facility.
• The optical density of the
film in the center of the phantom image shall not be less than 1.20.
2. kVp accuracy and reproducibility.
• The kVp shall be accurate
within plus or minus 5 percent of the indicated or selected kVp at the lowest
clinical kVp that can be measured by a kVp test device, the most commonly used
clinical kVp, and the highest available clinical kVp.
• At the most commonly used
clinical settings of kVp, the coefficient of variation of reproducibility of the
kVp shall be equal to or less than 0.02.
3. Focal spot condition. Until October 28, 2002, focal spot
condition shall be evaluated either by determining system resolution or by
measuring focal spot dimensions. On and after October 28, 2002, facilities
shall evaluate focal spot condition only by determining the system
resolution.
• Each X–ray system
used for mammography, in combination with the mammography screen–film
combination used in the facility, shall provide a minimum resolution of 11
cycles/millimeters (mm) (line–pairs/mm) when a high contrast resolution
bar test pattern is oriented with the bars perpendicular to the
anode–cathode axis, and a minimum resolution of 13 line–pairs/mm
when the bars are parallel to that axis.
• The bar pattern shall be
placed 4.5 centimeters above the breast support surface, centered with respect
to the chest wall edge of the image receptor, and with the edge of the pattern
within 1 centimeter of the chest wall edge of the image receptor.
• When more than one target
material is provided, the measurement above shall be made using the appropriate
focal spot for each target material.
• When more than one SID is
provided, the test shall be performed at the SID most commonly used
clinically.
• Test kVp shall be set at
the value used clinically by the facility for a standard breast and shall be
performed in the AEC mode, if available. If necessary, a suitable absorber may
be placed in the beam to increase exposure times. The screen–film
cassette combination used by the facility shall be used to test for this
requirement and shall be placed in the normal location used for clinical
procedures.
• Focal
spot dimensions. Measured values of the focal spot length (dimension parallel
to the anode–cathode axis) and width (dimension perpendicular to the
anode–cathode axis) shall be within tolerance limits specified in Table
1.
Table 1
Focal Spot Tolerance Limit
Nominal Focal Spot Size (mm)
|
Maximum Measured Dimensions Width (mm)
|
Length (mm)
|
0.10
|
0.15
|
0.15
|
0.15
|
0.23
|
0.23
|
0.20
|
0.30
|
0.30
|
0.30
|
0.45
|
0.65
|
0.40
|
0.60
|
0.85
|
0.60
|
0.90
|
1.30
|
4. Beam quality and half–value layer (HVL). The HVL
shall meet the specification of 41.1(4) and 41.1(6) for the minimum HVL. These
values, extrapolated to the mammographic range, are shown in Table 2. Values
not shown in Table 2 may be determined by linear interpolation or
extrapolation.
Table 2
X–ray Tube Voltage (kilovolt peak) and Minimum HVL
Designed Operating Range (kV) Below 50
|
Measured Operating Voltage (kV)
|
Minimum HVL (millimeters of aluminum)
|
20
|
0.20
|
25
|
0.25
|
30
|
0.30
|
5. Breast entrance air kerma and AEC reproducibility. The
coefficient of variation for both air kerma and mAs shall not exceed
0.05.
6. Dosimetry. The average glandular dose delivered during a
single cranio–caudal view of an FDA–accepted phantom simulating a
standard breast shall not exceed 0.3 rad (3.0 milligray (mGy)) per exposure.
The dose shall be determined with technique factors and conditions used
clinically for a standard breast.
7. X–ray field/light field/image receptor/compression
paddle alignment.
• All systems shall have
beam–limiting devices that allow the useful X–ray beam to extend to
or beyond the edges of the image receptor but by no more than 2 percent of the
SID at the chest wall side.
• If a light field that
passes through the X–ray beam limitation device is provided, it shall be
aligned with the X–ray field so that the total of any misalignment of the
edges of the light field and the X–ray field along either the length or
the width of the visually defined field at the plane of the breast support
surface shall not exceed 2 percent of the SID.
• The chest wall edge of the
compression paddle shall not extend beyond the chest wall edge of the image
receptor by more than 1 percent of the SID when tested with the compression
paddle placed above the breast support surface at a distance equivalent to
standard breast thickness. The shadow of the vertical edge of the compression
paddle shall be not be visible on the image.
8. Uniformity of screen speed. Uniformity of screen speed of
all the cassettes in the facility shall be tested and the difference between the
maximum and minimum optical densities shall not exceed 0.30. Screen artifacts
shall also be evaluated during this test.
9. System artifacts. System artifacts shall be evaluated with
a high–grade, defect–free sheet of homogeneous material large enough
to cover the mammography cassette and shall be performed for all cassette sizes
used in the facility using a grid appropriate for the cassette size being
tested. System artifacts shall also be evaluated for all available focal spot
sizes and target filter combinations used clinically.
10. Radiation output.
• The system shall be capable
of producing a minimum output of 513 milliRoentgen (mR) per second (4.5 mGy air
kerma per second) when operating at 28 kVp in the standard mammography
(moly/moly) mode at any SID where the system is designed to operate and when
measured by a detector with its center located 4.5 centimeters above the breast
support surface with the compression paddle in place between the source and the
detector. After October 28, 2002, the system, under the same measuring
conditions, shall be capable of producing a minimum output of 800 mR per second
(7.0 mGy air kerma per second) when operating at 28 kVp in the standard
(moly/moly) mammography mode at any SID where the system is designed to
operate.
• The system shall be capable
of maintaining the required minimum radiation output averaged over a 3.0 second
period.
11. Decompression. If the system is equipped with a provision
for automatic decompression after completion of an exposure or interruption of
power to the system, the system shall be tested to confirm that it
provides:
• An override capability to
allow maintenance of compression;
• A continuous display of the
override status; and
• A manual emergency
compression release that can be activated in the event of power or automatic
release failure.
(6) Quality control tests—other modalities. For systems
with image receptor modalities other than screen–film, the quality
assurance program shall be substantially the same as the quality assurance
program recommended by the image receptor manufacturer, except that the maximum
allowable dose shall not exceed the maximum allowable dose for screen–film
systems in 41.6(5)“k”(6).
(7) Mobile units. The facility shall verify that mammography
units used to produce mammograms at more than one location meet the requirements
in 41.6(5)“k.” In addition, at each examination location, before
any examinations are conducted, the facility shall verify satisfactory
performance of such units using a test method that establishes the adequacy of
the image quality produced by the unit.
(8) Use of test results.
1. After completion of the tests specified in
41.6(5)“k,” the facility shall compare the test results to the
corresponding specified action limits; or, for non–screen–film
modalities, to the manufacturer’s recommended action limits; or, for
postmove, preexamination testing of mobile units, to the limits established in
the test method used by the facility.
2. If the test results fall outside of the action limits, the
source of the problem shall be identified, and corrective actions shall be
taken:
• Before any further
examinations are performed or any films are processed using the component of the
mammography system that failed the test, if the failed test was that described
in 41.6(5)“k”(1) through (7);
• Within 30 days of the test
date for all other tests described in 41.6(5)“k.”
(9) Surveys.
1. At least once a year, each facility shall undergo a survey
by a medical physicist or by an individual under the direct supervision of a
medical physicist. At a minimum, this survey shall include the performance of
tests to ensure that the facility meets the quality assurance requirements of
the annual tests described in 41.6(5)“k”(5) and (6) and the weekly
phantom image quality test described in 41.6(5)“k”(2).
2. The results of all tests conducted by the facility in
accordance with 41.6(5)“k”(1) through (7), as well as written
documentation of any corrective actions taken and their results, shall be
evaluated for adequacy by the medical physicist performing the survey.
3. The medical physicist shall prepare a survey report that
includes a summary of this review and recommendations for necessary
improvements.
4. The survey report shall be sent to the facility within 30
days of the date of the survey.
5. The survey report shall be dated and signed by the medical
physicist performing or supervising the survey. If the survey was performed
entirely or in part by another individual under the direct supervision of the
medical physicist, that individual and the part of the survey that individual
performed shall also be identified in the survey report.
(10) Mammography equipment evaluations. Additional
evaluations of mammography units or image processors shall be conducted whenever
a new unit or processor is installed, a unit or processor is disassembled and
reassembled at the same or a new location, or major components of a mammography
unit or processor equipment are changed or repaired. These evaluations shall be
used to determine whether the new or changed equipment meets the requirements of
applicable standards in 41.6(5). All problems shall be corrected before the new
or changed equipment is put into service for examinations or film processing.
The mammography equipment evaluation shall be performed by a medical physicist
or by an individual under the direct supervision of an Iowa–approved
medical physicist.
(11) Facility cleanliness.
1. The facility shall establish and implement adequate
protocols for maintaining darkroom, screen, and viewbox cleanliness.
2. The facility shall document that all cleaning procedures
are performed at the frequencies specified in the protocols.
(12) Calibration of air kerma measuring instruments.
Instruments used by medical physicists in their annual survey to measure the air
kerma or air kerma rate from a mammography unit shall be calibrated at least
once every two years and each time the instrument is repaired. The instrument
calibration must be traceable to a national standard and calibrated with an
accuracy of plus or minus 6 percent (95 percent confidence level) in the
mammography energy range.
(13) Infection control. Facilities shall establish and comply
with a system specifying procedures to be followed by the facility for cleaning
and disinfecting mammography equipment after contact with blood or other
potentially infectious materials. This system shall specify the methods for
documenting facility compliance with the infection control procedures
established and shall:
1. Comply with all applicable federal, state, and local
regulations pertaining to infection control; and
2. Comply with the manufacturer’s recommended procedures
for the cleaning and disinfecting of the mammography equipment used in the
facility; or
3. If adequate manufacturer’s recommendations are not
available, comply with generally accepted guidance on infection control, until
such recommendations become available.
l. Mammography procedures and techniques for mammography of
patients with breast implants.
(1) Each facility shall have a procedure to inquire whether or
not the patient has breast implants prior to the actual mammographic
examination.
(2) Except where contraindicated, or unless modified by a
physician’s directions, patients with breast implants undergoing
mammography shall have mammographic views to maximize the visualization of
breast tissue.
m. Consumer complaint mechanism. Each facility
shall:
(1) Establish a written and documented system for collecting
and resolving consumer complaints;
(2) Maintain a record of each serious complaint received by
the facility for at least three years from the date the complaint was
received;
(3) Provide the consumer with adequate directions for filing
serious complaints with the facility’s accreditation body and any other
appropriate regulatory entity if the facility is unable to resolve a serious
complaint to the consumer’s satisfaction.
(4) Report unresolved serious complaints to the accreditation
body in a manner and time frame specified by the accreditation body.
n. Clinical image quality. Clinical images produced by any
certified facility must continue to comply with the standards for clinical image
quality established by that facility’s accreditation body.
o. Additional mammography review and patient
notification.
(1) If the agency believes that mammography quality at a
facility has been compromised and may present a serious risk to human health,
the facility shall provide clinical images and other relevant information, as
specified by the agency, for review by the accreditation body or other entity
designated by the agency. This additional mammography review will help the
agency to determine whether the facility is in compliance with rule
641—41.6(136C) and, if not, whether there is a need to notify affected
patients, their physicians, or the public that the reliability, clarity, and
accuracy of interpretation of mammograms has been compromised.
(2) If the agency determines that any activity related to the
provision of mammography at a facility may present a serious risk to human
health such that patient notification is necessary, the facility shall notify
patients or their designees, their physicians, or the public of action that may
be taken to minimize the effects of the risk. Such notification shall occur
within a time frame and a manner specified by the agency.
ITEM 73. Amend subrule 41.6(6) as
follows:
41.6(6) Equipment standards. The equipment used to
perform mammography shall meet the following standards:
a. Be specifically designed for mammography. This
prohibits systems that have been modified or equipped with special attachments
for mammography.
b. Meet the Food and Drug Administration (FDA) performance
standards for diagnostic X–ray systems and their major components found in
21 CFR 1020.30 and FDA standards for radiographic equipment in 21 CFR
1020.31
641-
41.1(136C).
c. Have image receptor systems and individual components which
are appropriate for mammography and used according to the manufacturer’s
recommendations.
(1) Systems using screen–film image receptors shall
provide, at a minimum, for operation for image receptors of 18
× 24 centimeters and 24
× 30 centimeters.
(2) Systems using screen–film image receptors shall
be equipped with moving grids matched to all image receptor sizes
provided.
(3) Systems used for magnification procedures shall be
capable of operation with the grid removed from between the source and image
receptor.
d. Have beam limitation which limits the useful beam
so that the X–ray field at the plane of the image receptor does not extend
beyond any edge of the image receptor at any designated source to image receptor
distance (SID). However, the X–ray field may extend beyond the edge of
the image receptor which is adjacent to the chest wall provided it does not
extend beyond this edge by more than 2 percent of the SID.
d. Have beam–limiting devices that allow the useful
beam to extend to or beyond the chest wall edge of the image receptor. For any
system with a light beam that passes through the X–ray beam–limiting
device, the light shall provide an average illumination of not less than 160 lux
(15 foot candles) at 100 centimeters or the maximum source–image receptor
distance (SID), whichever is less.
e. Magnification:
(1) Systems used to perform noninterventional
problem–solving procedures shall have radiographic magnification
capability available for use by the operator.
(2) Systems used for magnification procedures shall
provide, at a minimum, at least one magnification value within the range of 1.4
to 2.0.
e f. Check Shall
check film/screen contact when cassettes are first placed into use and
semiannually thereafter.
f. Have limits to provide kV–target–filter
combinations appropriate for the image receptors which have met the requirements
of 41.6(6)“c.”
g. The focal spot size, magnification factor and source to
image receptor distance (SID) are appropriate for mammography and in the ranges
shown below:
SID
|
Nominal Focal Spot Size
|
> 65 cm
|
< or = to 0.6 mm
|
50 to 65 cm
|
< or = to 0.5 mm
|
< or = to 50 cm
|
< or = to 0.4 mm
|
(1) When more than one focal spot is provided, the system
shall indicate, prior to exposure, which focal spot is selected.
(2) When more than one target material is provided, the
system shall indicate, prior to exposure, the preselected target
material.
(3) When the target material or focal spot, or both, is
selected by a system algorithm that is based on the exposure or on a test
exposure, the system shall display, after the exposure, the target material or
focal spot, or both, actually used during the exposure.
h. Devices Shall have compression
devices parallel to the imaging plane shall be available
and able to immobilize and compress the breast with a force of
at least 25 pounds per square inch and shall be capable of maintaining this
compression for at least three seconds. Effective October 28, 2002, each
system shall provide:
(1) An initial power–driven compression activated by
hands–free controls operable from both sides of the patient;
and
(2) Fine adjustment compression controls operable from both
sides of the patient.
(3) Systems shall be equipped with different sized
compression paddles that match the sizes of all full field image receptors
provided for the system. Compression paddles for special purposes, including
those smaller than the full size of the image receptor (for “spot
compression”), may be provided. Such compression paddles for special
purposes are not subject to 41.6(6)“h”(6) and (7).
(4) Except as provided in 41.6(6)“h”(5), the
compression paddle shall be flat and parallel to the breast support table and
shall not deflect from parallel by more than 1.0 cm at any point on the surface
of the compression paddle when compression is applied.
(5) Equipment intended by the manufacturer’s design
not to be flat and parallel to the breast support table during compression shall
meet the manufacturer’s design specifications and maintenance
requirements.
(6) The chest wall edge of the compression paddle shall be
straight and parallel to the edge of the image receptor.
(7) The chest wall edge may be bent upward to allow for
patient comfort but shall not appear on the image.
i. Shall have the capability for using antiscatter
grids.
j. Shall have the capability of automatic exposure
control.
j. Shall have automatic exposure control such
that:
(1) Each screen–film system shall provide an AEC mode
that is operable in all combinations of equipment configuration provided, e.g.,
grid, nongrid; magnification, nonmagnification; and various target–filter
combinations.
(2) The positioning or selection of the detector shall
permit flexibility in the placement of the detector under the target
tissue.
• The size and
available positions of the detector shall be clearly indicated at the
X–ray input surface of the breast compression paddle.
• The selected
position of the detector shall be clearly indicated.
(3) The system shall provide means for the operator to vary
the selected optical density from the normal (zero) setting.
k. Shall have a control panel that:
(1) Gives a positive indication when X–rays are being
produced.
(2) Gives an audible signal indicating termination of
exposure.
(3) Includes labeled control settings or appropriate
indications that show the physical factors used for exposure such as kilovoltage
potential (kVp), milliampere seconds (mAs), exposure time, and whether exposure
termination is automatic.
(3) Has manual selection of milliampere seconds (mAs) or at
least one of its component parts (milliampere (mA) or time, or
both).
(4) Has the technique factors (peak tube potential in
kilovolts (kV) and either tube current in mA and exposure time in seconds or the
product of tube current and exposure time in mAs) to be used during an exposure
indicated before the exposure begins, except when AEC is used, in which case the
technique factors that are set prior to the exposure shall be
indicated.
(5) Has a system that, following AEC mode use, shall
indicate the actual kilovoltage peak (kVp) and mAs used during the exposure.
The mAs may be displayed as mA and time.
l. Shall indicate, or provide a means of determining, the mAs
resulting from each exposure made with automatic exposure control.
m. The viewbox shall be Shall have a
viewbox that is checked periodically to ensure optimal conditions. When the
mammogram is placed on the viewbox, the area surrounding the film must be masked
to exclude extraneous light which may reduce image contrast.
n. Mobile units and vans.
(1) A phantom image shall be made and processed after
each relocation.
(2) If processing is not available, a check of the
radiation output shall be made.
Equipment shall be recalibrated as necessary to
maintain quality of phantom image.
n. Shall use X–ray film that has been
designated by the film manufacturer as appropriate for mammography and that is
matched to the screen’s spectral output as specified by the
manufacturer.
o. Shall use intensifying screens that have been designated
by the screen manufacturer as appropriate for mammography.
p. Shall use chemical solutions for processing mammography
films that are capable of developing the films in a manner equivalent to the
minimum requirements specified by the film manufacturer.
q. Shall make special lights for film illumination, i.e.,
hot–lights, capable of producing light levels greater than that provided
by the viewbox, available to the interpreting physicians.
r. Shall ensure that film masking devices that can limit
the illuminated area to a region equal to or smaller than the exposed portion of
the film are available to all interpreting physicians interpreting for the
facility.
s. For mobile units and vans.
(1) A phantom image shall be produced, processed, and
evaluated after each relocation.
(2) If processing is not available, a check of the
radiation output shall be made and compared to a preset standard for quality.
Equipment shall be recalibrated as necessary to maintain quality of phantom
image.
ITEM 74. Amend rule
641—41.6(136C), Appendix I, as follows:
RULE 41.6(136C)—APPENDIX I
Normally, the frequency of monitoring for each of the
following should be no longer than the values given on the following table. The
standards of image quality are also given on the table. The surveyor is
expected to measure phantom image quality and calculate dose from a measured
exposure to confirm that the guidelines meet the desired standards of image
quality. The surveyor will determine if the other standards are met by checking
the supplier’s monitoring records.
ITEMS
|
|
FREQUENCY
|
|
STANDARDS OF IMAGE QUALITY
|
Processor
|
|
Daily
|
|
Mid–density step and density difference (contrast) <
?0.1 OD of the optimized operating level and
base + fog deviation ? 0.03 OD
|
HVL
|
|
Annually
|
|
Meas. HVL with compression device in field
? (kVp/100) mm Al and < (kVp/100
+ 0.1 mm Al)
|
Output reproducibility
|
|
*Quarterly
|
|
Coefficient of variation ?
0.05 with 4 exposures at the same technique
|
Output linearity
|
|
*Quarterly
|
|
mR/mAs values at any two consecutive tube current settings
should not vary more than 0.1 times their sum.
|
Automatic exposure control reproducibility
|
|
Annually
|
|
The phantom used for measurements related to this and the two
following automatic control parameters should be either acrylic or BR–12
and consist of at least three 2–cm–thick slabs to provide
thicknesses of 2 cm, 4 cm, and 6 cm (each having linear dimensions of at least 8
× 10 cm). When a fixed kVp is used to produce
four images of the 4–cm–thick phantom, the maximum value for the
coefficient of variation for exposure at the center of the image should be
? 0.05.
|
kVp response of
automatic exposure
|
|
Annually
|
|
Film density maintained to
?0.3 OD of the average optical density at the
center of an exposure control phantom image over the range of kVp used in the
facility. To obtain the average, at least four phantom images should be made,
one each with the highest and lowest kVps commonly used in the facility and the
other two at intermediate values.
|
Thickness response of automatic exposure control
|
|
Annually
|
|
Film density maintained to
?0.3 OD of the average optical density at the
center of a phantom image at each kVp commonly used in the facility. To obtain
the average, images with phantom thickness of at least 2 cm, 4 cm, and 6 cm
should be used.
|
Adequacy of unexposed film storage
|
|
Quarterly
|
|
Increase in base + fog density over storage time
maintained to < 0.02 OD
|
Availability and use of technique charts
|
|
Monthly
|
|
Ensure that charts are available and used
|
kVp/target/filter combination
|
|
Daily
|
|
Must be unchanged from that indicated on the technique
charts
|
Darkroom integrity
|
|
Clean Daily Fog measured when bulbs or filter changed and
semiannually
|
|
Minimum dust particles on film. Fog not greater than 0.05 OD
with 2–minute test
|
Phantom image quality
|
|
At least monthly weekly
|
|
Phantom image scores not less than required ACR MAP (currently
specified only using RMI phantoms) and that should not decrease more than one in
any category between consecutive tests. Also, they should not have decreased by
more than one in any category from the initial baseline phantom image.
|
Dose
|
|
Annually
|
|
See Appendix II
|
*If the supplier can document that the item has remained
within limits for at least three consecutive monitoring periods, it may use a
longer monitoring interval for any parameters except processor performance and
phantom image quality. The period should not be longer than one year in any
case. If during the longer monitoring interval the test results fall outside
the “Standards of Image Quality” criteria, then the test frequency
must revert to the original intervals for at least three consecutive
quarters.
ITEM 75. Amend subrule 41.7(1) as
follows:
41.7(1) Definitions. In addition to the definitions
provided in rule 641-38.2(136C),
641-40.2(136C), and
641-41.1(136C), the following definitions
are applicable to this rule.
ITEM 76. Amend
641-Chapter 41, Appendix
B, “3,” as follows:
3. X–ray control placement:
The X–ray control for the system shall be fixed within
the booth; and
(a) Shall be at least 40 inches (1.02 m) from any point
subject to direct scatter, leakage or primary beam radiation.
(b) Shall allow the operator to use the majority of the
available viewing windows or mirrors.
ITEM 77. Amend subrule 42.2(2) by
adopting new paragraph “f” as
follows:
f. Performing procedures not allowed under the
individual’s current certification.
ITEM 78. Amend subparagraph
42.3(1)“a”(7) as follows:
(7) Clinical experience sufficient to demonstrate competency
in the application of the above as specified in the revised 1990 edition
of the “Essentials and Guidelines of an Accredited Educational Program for
the Radiographer” of the American Medical Association’s Committee on
Allied Health Education and Accreditation.
“Standards for an Accredited Education Program in
Radiologic Sciences” as adopted by the Joint Review Committee on Education
on Radiologic Technology.
ITEM 79. Amend subrule 45.1(2) as
follows:
Adopt the following new definitions in
alphabetical order:
“Annual refresher safety training” means a review
conducted or provided by the licensee for its employees on radiation safety
aspects of industrial radiography. The review may include, as appropriate, the
results of internal inspections, new procedures or equipment, new or revised
regulations, accidents or errors that have been observed, and should also
provide opportunities for employees to ask safety questions.
“Associated equipment” means equipment that is
used in conjunction with a radiographic exposure device to make radiographic
exposures that drives, guides, or comes in contact with the source, e.g., guide
tube, control tube, control (drive) cable, removable source stop,
“J” tube and collimator when it is used as an exposure
head.
“Certifying entity” means an independent
certifying organization meeting the requirements in Appendix E of this chapter
or Agreement State meeting the requirements of Appendix E or the requirements of
Appendix A in 10 CFR Part 34.
“Control (drive) cable” means the cable that is
connected to the source assembly and used to drive the source to and from the
exposure location.
“Control drive mechanism” means a device that
enables the source assembly to be moved to and from the exposure
device.
“Control tube” means a protective sheath for
guiding the control cable. The control tube connects the control drive
mechanism to the radiographic exposure device.
“Exposure head” means a device that locates the
gamma radiography sealed source in the selected working position. (An exposure
head is also known as a source stop.)
“Field station” means a facility where licensed
material may be stored or used and from which equipment is dispatched.
“Guide tube (projection sheath)” means a flexible
or rigid tube (i.e., “J” tube) for guiding the source assembly and
the attached control cable from the exposure device to the exposure head. The
guide tube may also include the connections necessary for attachment to the
exposure device and to the exposure head.
“Hands–on experience” means experience in
all of those areas considered to be directly involved in the radiography
process.
“Independent certifying organization” means an
independent organization that meets all of the criteria of Appendix E to this
chapter.
“Permanent radiographic installation” means an
enclosed shielded room, cell, or vault, not located at a temporary job site, in
which radiography is performed.
“Practical examination” means a demonstration
through practical application of the safety rules and principles in industrial
radiography including use of all appropriate equipment and procedures.
“Radiographer certification” means written
approval received from a certifying entity stating that an individual has
satisfactorily met certain established radiation safety, testing, and experience
criteria.
“Radiographic operations” means all activities
associated with the presence of radioactive sources in a radiographic exposure
device during use of the device or transport (except when being transported by a
common or contract transport), to include surveys to confirm the adequacy of
boundaries, setting up equipment and any activity inside restricted area
boundaries.
“S–tube” means a tube through which the
radioactive source travels when inside a radiographic exposure device.
Amend the following definitions:
“Shielded position” means the location within the
radiographic exposure device or storage container which, by
manufacturer’s design, is the proper location for the sealed source during
storage source changer where the sealed source is secured and
restricted from movement.
“Source assembly” means a component to
which the sealed source is affixed or in which the sealed source is contained.
The source assembly includes the sealed source (pigtail) an assembly
that consists of the sealed source and a connector that attaches the source to
the control cable. The source assembly may also include a stop ball used to
secure the source in the shielded position.
ITEM 80. Amend subrule 45.1(5),
paragraph “c,” as follows:
c. Records of these calibrations shall be maintained for
two three years after the calibration date for
inspection by the agency.
ITEM 81. Amend subrule 45.1(7) as
follows:
45.1(7) Utilization logs.
a. Each licensee or registrant shall maintain
current logs of the use of each sealed source of
radiation. The logs shall include:
(1) A unique identification, such as which
includes the make, model and a serial number
of each radiation machine, of each radiographic exposure
device containing a sealed source, and each sealed source;
(2) The identity of the radiographer using the sealed
source of radiation;
(3) Locations where each sealed source of
radiation is used; and
(4) The date(s) each sealed source of
radiation is removed from storage and returned to storage. For
fixed installations, the date(s) each source of radiation is energized or used
and the number of exposures made.
b. Each registrant shall maintain current logs of the use
of each source of radiation. The logs shall include:
(1) A unique identification, which includes the make, model
and serial number of each source of radiation;
(2) The identity of the radiographer using the source of
radiation;
(3) The date(s) each source of radiation is energized or
used and the number of exposures made.
b c. Utilization logs may be kept on
IDPH Form 588–2693, Utilization Log, or on clear, legible records
containing all the information required by 45.1(7)“a.” Copies of
utilization logs shall be maintained for agency inspection for
two three years from the date of the recorded event.
The rec–ords shall be kept at the location specified by the license or
certificate of registration.
ITEM 82. Amend subrule 45.1(9),
paragraph “b,” as follows:
b. The control device or alarm system shall be tested for
proper operation at the beginning of each day of equipment use. If a control
device or alarm system is operating improperly, it shall be immediately labeled
as defective and repaired before industrial radiographic operations are resumed.
Rec–ords of these tests shall be maintained for inspection by the agency
for two three years from the date of the
event.
ITEM 83. Rescind
45.1(10)“b”(1)“2” and adopt the following
new numbered paragraph “2” in lieu
thereof:
2. Has completed on–the–job training as a
radiographic trainee supervised by one or more radiographic trainers. The
on–the–job training shall be documented on the appropriate agency
form or equivalent and shall include a minimum of two months (320 hours) of
active participation in the performance of industrial radiography utilizing
radioactive material or one month (160 hours) of active participation in the
performance of industrial radiography utilizing radiation machines, or both.
Individuals performing industrial radiography utilizing radioactive materials
and radiation machines must complete both segments of the on–the–job
training (three months or 480 hours). Active participation does not include
safety meetings or classroom training;
ITEM 84. Amend subrule 45.1(10),
paragraph “d,” introductory paragraph, as follows:
d. Radiation safety officer. The radiation safety officer
shall ensure that radiation safety activities are being performed in accordance
with approved procedures and regulatory requirements in the daily operation of
the licensee’s program.
ITEM 85. Amend
45.1(10)“g”(1)“1” as follows:
1. An I.D. card shall be issued to each person who
successfully completes the requirements of 45.1(10)“b” and the
examination prescribed in 45.1(10)“f”(2) or an equivalent
exam examination. Certification by a certifying
entity in accordance with 10 CFR 34.43(a)(1) meets the examination requirements
of 45.1(10)“f”(2) but not the requirements of
45.1(10)“b”(1).
ITEM 86. Rescind subrule 45.1(11) and
adopt the following new subrule in lieu thereof:
45.1(11) Internal audits. Except as provided in
45.1(11)“c,” the RSO or designee shall conduct an inspection program
of the job performance of each radiographer and radiographer trainee to ensure
that these rules, license requirements, and the licensee’s or
registrant’s operating and emergency procedures are followed. The
inspection program must:
a. Include observation of the performance of each radiographer
and radiographer trainee during an actual industrial radiographic operation, at
intervals not to exceed six months; and
b. Provide that, if a radiographer or radiographer trainee has
not participated in an industrial radiographic operation for more than six
months since the last audit, the radiographer or radiographer trainee must
demonstrate understanding of the subjects contained in Appendix A of this
chapter by a practical examination before these individuals can next participate
in a radiographic operation.
c. The agency may consider alternatives in those situations
where the individual serves as both radiographer and RSO.
d. Records of audits shall be maintained by the licensee or
registrant for agency inspection for three years from the date of the
audit.
ITEM 87. Amend paragraph
45.1(12)“b” as follows:
b. When performing industrial radiographic
operations:
(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 the
each individual wears, on the trunk of the body, a combination of
a direct–reading pocket dosimeter, an operating
alarm ratemeter, and either a film badge, an optically stimulated device
(OSD) or a thermoluminescent dosimeter (TLD) at all times during the
radiographic operations. 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.
(3) Pocket dosimeters or electronic personal dosimeters
shall be recharged at the start of each work shift.
(4) Pocket dosimeters or electronic personal dosimeters
shall be read and exposures recorded at least once daily, at the end of each
work shift, and before each recharging.
(5) If an individual’s pocket dosimeter is discharged
beyond its range (i.e., goes “off scale”), or if the electronic
personal dosimeter reads greater than 200 millirem (2 millisievert), and the
possibility of radiation exposure cannot be ruled out as the cause,
industrial radiographic operations by that individual shall cease and the
individual’s film badge or TLD shall be within 24 hours sent for
processing. The individual shall not return to work with sources of radiation
until a determination of the radiation exposure has been made. This
determination must be made by the RSO or the RSO’s designee. The results
of this determination must be included in the exposure records maintained in
accordance with
641-
Chapter 40.
(6) Each film badge, OSD or TLD shall be assigned to
and worn by only one individual.
(7) Film badges, OSDs and TLDs must be replaced at
least monthly. After replacement, each film badge, OSD or TLD must be
returned to the supplier for processing within 14 calendar days of the exchange
date specified by the personnel monitoring supplier.
(8) If a film badge, OSD or TLD is lost or damaged, the
worker shall cease work immediately until a replacement film badge, OSD
or TLD is provided and the exposure is calculated for the time period from
issuance to loss or damage of the film badge, OSD or TLD.
ITEM 88. Amend subrule 45.1(13) as
follows:
45.1(13) Supervision of radiographer trainee.
Whenever a radiographer trainee uses radiographic exposure devices, sealed
sources or related source handling tools or conducts radiation surveys required
by 45.2(5) or 45.3(7) to determine that the sealed source has returned to the
shielded position after an exposure, the radiographer trainee shall be under the
personal supervision of a radiographer instructor. The personal supervision
must include:
a. The radiographer’s physical presence at the site
where the source(s) of radiation is being used;
b. The availability of the radiographer to give immediate
assistance if required; and
c. The radiographer’s direct observation of the
trainee’s performance of the operations referred to in this
subrule.
ITEM 89. Rescind subrule 45.3(1)
and adopt the following new subrule in lieu thereof:
45.3(1) Limits on external radiation levels from
storage containers and source changers. The maximum exposure rate limits for
storage containers and source changers are 200 millirem (2 millisieverts) per
hour at any exterior surface, and 10 millirem (0.1 millisievert) per hour at 1
meter from any exterior surface with the sealed source in the shielded
position.
ITEM 90. Amend subrule 45.3(2),
paragraph “a,” as follows:
a. Each source of radiation shall be provided with a lock or
lockable outer container designed to prevent unauthorized or accidental removal
or exposure of a sealed source and shall be kept locked and, if applicable,
the key removed, at all times except when under the direct surveillance of a
radiographer or radiographer trainee, or as may be otherwise authorized pursuant
to 45.3(6). Each storage container and source changer likewise shall be
provided with a lock and shall be kept locked when containing sealed sources
except when the container is under the direct surveillance of a radiographer or
radiographer trainee.
ITEM 91. Amend subparagraph
45.3(4)“c”(5) as follows:
(5) The guide tube must have passed the crushing tests
for the control tube as specified in ANSI N432 and a kinking resistance test
that closely approximates the kinking forces likely to be encountered during
use be able to withstand a crushing test that closely approximates
the crushing forces that are likely to be encountered during use, and be able to
withstand a kinking resistance test that closely approximates the kinking forces
that are likely to be encountered during use;
ITEM 92. Amend subparagraph
45.3(4)“c”(8) as follows:
(8) The guide tube exposure head connection must be able to
withstand the tensile test for control units specified in ANSI
N432–1980;
ITEM 93. Amend subrule 45.3(4) by
adopting new paragraphs “f” and
“g” as follows:
f. Notwithstanding the requirements of 45.3(4)“a,”
equipment used in industrial radiographic operations need not comply with §
8.9.2© of the Endurance Test in American
National Standards Institute N432–1980, if the prototype equipment has
been tested using a torque value representative of the torque that an individual
using the radiography equipment can realistically exert on the lever or
crankshaft of the drive mechanism.
g. Engineering analysis may be submitted by an applicant or
licensee to demonstrate the applicability of previously performed testing on
similar individual radiography equipment components. Upon review, the agency
may find this an acceptable alternative to actual testing of the component
pursuant to the above referenced standard.
ITEM 94. Rescind paragraph
45.3(5)“b” and adopt the following new
paragraph in lieu thereof:
b. Leak testing.
(1) Each sealed source shall be tested for leakage at
intervals not to exceed 6 months. In the absence of a certificate from a
transferor indicating that a test has been made within the 6–month period
prior to the transfer, the sealed source shall not be put into use until
tested.
(2) Each exposure device using depleted uranium (DU) shielding
and an S–tube configuration must be tested for DU contamination at
intervals not to exceed 12 months. Should the leak test reveal that the
S–tube is worn through, the device may not be used again. DU shielded
devices do not have to be tested for DU contamination while in storage and not
in use. Before using or transferring such a device, however, the device must be
tested for DU contamination if the interval of storage exceeded 12
months.
ITEM 95. Amend paragraph
45.3(6)“a,” subparagraphs (9) and (10), and
adopt new subparagraphs (11) and (12) as
follows:
(9) Maintenance of records; and
(10) The inspection and maintenance of radiographic exposure
devices, source changers, storage containers, and radiation
machines.;
(11) The procedure(s) for identifying and reporting
defects and noncompliance in 10 CFR Part 21; and
(12) Source recovery procedure if the licensee will perform
source recovery.
ITEM 96. Amend subrule 45.3(6),
paragraph “c,” as follows:
c. Each licensee shall provide, as a minimum, two
radiographic personnel when sources of radiation are used for any industrial
radiography conducted other than at a permanent radiographic installation
(shielded room, bay, bunker). Whenever radiography is performed at a
location other than a permanent radiographic installation, the radiographer must
be accompanied by at least one other qualified radiographer or a radiographer
trainee. If one of the personnel is a radiographer trainee, the other shall be
a radiographer trainer authorized by the license. The additional qualified
individual shall observe the operations and be capable of providing immediate
assistance to prevent unauthorized entry. Except for the situation of a
radiographer trainer with a trainee, radiography may not be performed if only
one qualified individual is present.
ITEM 97. Amend subrule 45.3(7),
paragraph “b,” as follows:
b. A survey with a calibrated and operable radiation survey
instrument shall be made after each radiographic exposure to determine that the
sealed source has been returned to its shielded position. The entire
circumference of the radiographic exposure device shall be surveyed. If the
radiographic exposure device has a source guide tube, the survey shall also
include the entire length of the guide tube and collimator. The survey
required by this subrule must be done before exchanging films, repositioning the
exposure head or dismantling the equipment.
ITEM 98. Amend subrule 45.3(9),
paragraph “a,” as follows:
a. Underwater, offshore platform, or lay–barge
radiography shall not be performed unless specifically authorized in a license
issued by the agency in accordance with 45.3(11).
641—paragraph 39.4(27)“e.”
ITEM 99. Rescind and reserve subrule
45.3(11).
ITEM 100. Amend subrule 45.4(2),
introductory paragraph, as follows:
45.4(2) Definitions. For purposes of this subrule,
definitions in 641—Chapter Chapters 38 and 40
and subrule 45.1(2) may also apply. As used in this rule, the following
definitions apply:
ITEM 101. Amend subrule 45.4(2) by
adopting the following new definition:
“Cold pasteurization” means the process of using
radiation for destroying disease–causing microorganisms in commercial
products.
ITEM 102. Amend subrule 45.4(11),
paragraph “c,” as follows:
c. Accelerator facilities registered pursuant to
45.4(3)“a” shall survey for removable contamination at intervals not
to exceed three six months to determine the degree of
contamination.
ITEM 103. Amend rule
641-46.1(136D), first unnumbered
paragraph, as follows:
All references to Code of Federal Regulations (CFR) in this
chapter are those in effect as of July 1, 1999 May 10,
2000.
ITEM 104. Amend subrule 46.5(1),
paragraph “c,” introductory paragraph, as follows:
c. A tanning facility shall provide each consumer with a
written warning statement prior to the consumer’s initial exposure and
annually thereafter which includes at least the following
information:
ARC 9623A
PUBLIC HEALTH
DEPARTMENT[641]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code section 135.11, the
Department of Public Health hereby proposes to amend Chapter 73, “Special
Supplemental Nutrition Program for Women, Infants, and Children (WIC),”
Iowa Administrative Code.
The purpose of amending Chapter 73 is to update the language
and definitions for consistency with the federal guidelines for the Special
Supplemental Nutrition Program for Women, Infants and Children. The amendments
include changes in terminology, clarification of the process for selecting
approved WIC foods, and tougher penalties for vendor abuse and fraud.
Due to rapidly changing technology, there are now many
alternatives to the WIC checks currently being utilized by the Iowa WIC Program
to supply food and formula to participants. The United States Department of
Agriculture (USDA) now uses the term “food instrument” to describe
all devices used to obtain supplemental foods. Chapter 73 has been modified to
reflect this change in terminology.
The process for determining whether a vendor has been
overcharging WIC participants has also been clarified in this revision of
Chapter 73, partly by defining the term “peer group” and explaining
its use. The use of the term “peer group” is not a change in
policy; it is simply a clarification of existing policy.
There has also been a change in the terminology used by
dietitians to describe certain juice products.
“Single–strength” is now used to describe what was previously
known as “fluid” juice, and “frozen” juice is now called
“concentrated” juice. Chapter 73 has been modified to reflect this
change.
Another change in Chapter 73 regards formula and infant cereal
stocking requirements for vendors. Due to a desire to improve participant
services, grocery vendors will now be required to have the capability to supply
participants with requested rebate contract formula within 48 hours, or 72 hours
if a holiday is involved. This is a change from the previous policy, which did
not specify how much time a vendor had to stock formula after a participant
request was received. Also, the new policy will not require vendors to keep
rare, expensive formulas in stock indefinitely, which is expected to attract
more small–town vendors that previously could not meet the formula
stocking requirements.
Chapter 73 is also being revised to clarify the process of
choosing brands of cereal for inclusion in the list of approved foods. The
total number of approved brands remains at 19, and the selection process is not
being modified. The proposed amendments simply specify the steps in the
existing process.
Chapter 73 is also being modified to reflect changes in the
way juices are chosen for inclusion in the approved foods list. The number of
approved brands for each type of juice has been decreased in order to eliminate
confusion at the grocery store, both for the vendors and the participants. This
will also assist staff in the administration of the program. Chapter 73 has
been modified to reflect this policy change.
The USDA has also recently recognized that tougher sanctions
are needed for vendors who commit violations of WIC program rules. The
implementation of mandatory sanctions by the USDA is intended to curb vendor
fraud in the WIC Program and to promote WIC and Food Stamp Program coordination
in the disqualification of vendors who violate Program rules. Chapter 73 has
been modified to implement the mandatory sanctions required by the
USDA.
The Department has provided an opportunity for its local
contractors, Medicaid staff of the Department of Human Services, and internal
staff of the Department of Public Health to review the revised chapter prior to
filing this Notice of Intended Action.
Any interested person may make written or oral suggestions or
comments on the amendments on or before February 15, 2000. Comments should be
directed to Mary L. Weaver, RN, MSN, Division Director, Family and Community
Health, Department of Public Health, Lucas State Office Building, Fifth Floor,
Des Moines, Iowa 50319–0075; telephone (515)281–4910 or fax
(515)242–6384.
There will also be a public hearing on Tuesday, February 15,
2000, from 12 noon to 1 p.m. utilizing the Iowa Communications Network (ICN).
The hearing will be conducted using 13 sites. Please telephone
(515)281–8857 to schedule a time to speak at the hearing. The following
ICN sites have been confirmed for the hearing:
LOCATION
|
ADDRESS
|
CONTACT
|
Scott Community College
ICN Classroom 1 Room 0210
|
500 Belmont Road, Bettendorf, IA
52722
|
Doug Kutzli
(319)441–4137
|
Burlington Nat’l Guard
Armory
ICN Classroom
|
2500 Summer Street, Burlington, IA
52601
|
Ed Glenn
(319)683–9826
|
University of Northern Iowa Schindler Ed.
Ctr.
Schindler 130A
|
Corner of Hudson Rd. and 23rd
Street
Cedar Falls, IA 50614
|
Em Pugh
(319)273–6294
|
Thomas Jefferson High School
|
1243 20th Street S.W. Cedar Rapids, IA
52404
|
Robert Tesar
(319)398–2435
|
Clear Lake
High School
ICN Classroom
|
125 N. 20th St.
Clear Lake, IA 50428
|
Carol Doerges
(515)357–5235
|
Southwestern Comm. College ICN Classroom
1
|
1501 W. Townline Rd.
Creston, IA 52132
|
Stacy Rockhold
(515)342–3531
|
Northeast Iowa Comm. College Trade Industry
Building 115
|
1625 Highway 150 Calmar, IA
52132
|
Deb Hageman
(800)728–2256 ext. 333
|
Department of Public Health
Conference Room Sixth Floor
|
Lucas State Office Building
321 E. 12th Street, Des Moines, IA
50319
|
Tim Lane
(515)281–7833
|
Iowa Lakes
Comm. College
Library Building Room 22
|
300 South 18th Street Estherville, IA
51334
|
Gary Feddern
(712)362–2604 ext. 128
|
Fort Dodge Army Aviation Support
Facility
|
1649 Nelson Ave. (Airport)
Fort Dodge, IA 50501
|
John Graves
(712)732–3901
|
National Guard Armory
ICN Room
|
2858 N. Court Road
Ottumwa, IA 52501
|
Ed Glenn
(515)683–9826
|
Dubuque Comm. School District
Forum Building
|
2300 Chaney
2nd Floor
Dubuque, IA 52001
|
Ann Alba
(319)588–5155
|
Central Campus
Individual
Learning Center
|
1121 Jackson St.,
Sioux City, IA 51105
|
Rick Ironside
(712)279–6072
|
Persons desiring to make oral presentations at the public
hearing should contact Mary Weaver at least one day prior to the date of the
public hearing. 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 hearing and who may have special
requirements, such as hearing or mobility impairments, should contact the
Department of Public Health and advise of specific needs.
These rules are subject to waiver pursuant to the
Department’s variance and waiver provisions contained at 641—
Chapter 178. For this reason, the Department has not provided a specific
provision for waiver of these particular rules.
These amendments are intended to implement Iowa Code section
135.11.
The following amendments are proposed.
ITEM 1. Amend rule
641—73.5(135) by adopting the following new
definitions in alphabetical order:
“Food instrument” means a voucher, check, coupon,
electronic benefits transfer (EBT) card or any other document used to obtain
supplemental foods.
“Peer group” means a system of grouping WIC
vendors according to structure, type, and number of cash registers. Peer groups
are used to establish statistical norms that an individual store may be compared
against and provide the numeric baselines for the process of determining what
may be fraudulent behavior.
ITEM 2. Amend rule 641—73.8(135),
introductory paragraph, as follows:
641—73.8(135) Food delivery. Food delivery
refers to all aspects of the method by which WIC participants receive food
benefits, i.e., printing, distribution, and processing of computerized personal
food checks instruments redeemable through retail food
markets and the statewide banking system. Food delivery shall be uniform
throughout the state as provided for by these rules.
ITEM 3. Amend subrule 73.8(1) as
follows:
73.8(1) Responsibilities of WIC
participants.
a. Prompt redemption of food checks
instruments. A WIC participant has 30 days from the date of issue in
which to cash any WIC check food instrument through a
vendor. The check food instrument becomes invalid after
this time.
b. Claiming food checks instruments.
Enrolled participants are required to appear in person to claim
checks food instruments when they have appointments to
certify or have nutrition education contacts. Missed attendance may entitle
contract agencies to deny that month’s benefit. If a written statement is
provided to the contract agency, a proxy may pick up checks
food instruments not more than twice during a single certification
period. Under limited circumstances, a permanent proxy may be approved by the
contract agency.
c. Adherence to standards for use of the food
check instrument. The WIC participant in using the WIC
check food instrument to obtain the specified foods
shall:
(1) Sign each check food instrument at
the time of receipt in the clinic.
(2) Present the blue ID folder to the vendor at point of
purchase.
(3) Sign each check food instrument a
second time in the appropriate box in the presence of the vendor.
(4) Write in the total amount of the purchase in the
designated space.
(5) Not accept money in exchange for unused
checks food instruments or portions of the food
allotment.
(6) Attempt to redeem checks food
instruments only with a WIC–contracted vendor.
ITEM 4. Amend subrule 73.8(2) as
follows:
73.8(2) Responsibilities of contract
agencies.
a. Loss or theft of checks food
instruments. The contract agency is responsible for any financial loss due
to theft or other loss of food checks instruments from
clinics. Steps for minimizing the chances of theft or loss are followed in
accord with the Iowa WIC Policy and Procedure Manual.
b. Mailing of WIC checks food
instruments. Mailing of checks food instruments to
participants is allowed when inclement weather prevents participants from coming
to a distribution site. Any mailing of WIC checks food
instruments on a clinicwide basis must have prior approval from the
state.
c. Use of manual checks food
instruments. Manually written checks food
instruments shall be issued only when:
(1) Computer checks food instruments
arrive damaged or mutilated, or are lost or stolen after being issued to
participant.
(2) Computer checks food instruments
are not available due to error in entering participant data, delay or loss in
shipping, or a need to change the food package.
d. Training/monitoring of WIC vendors. The contract agency
shall communicate information regarding the Iowa WIC program to vendors, as
instructed by the department. Monitoring and training of vendors and
annual biennial securement of contracts shall be carried
out in accord with department directives outlined in the WIC Policy and
Procedure Manual.
e. Check Food instrument distribution
on nonclinic days. It is the policy of the Iowa WIC program to ensure maximum
accessibility to program benefits by establishing alternate procedures for
distributing WIC checks food instruments to participants
on days other than regularly scheduled clinic days when the participant notified
the contract agency on or before the clinic day of the participant’s
inability to appear at the clinic. Each contract agency shall establish written
guidelines for assessing the adequacy of reasons presented for inability to
appear and shall establish written procedures for alternative means of
check food instrument distribution when a participant
timely presents adequate reasons for inability to appear on a regularly
scheduled clinic day. These written guidelines and procedures shall be subject
to review and approval by the department.
ITEM 5. Amend subrule 73.8(4) as
follows:
73.8(4) Responsibilities of WIC vendors. A potential
vendor shall make application to the Iowa department of public health WIC
program and shall accept the obligations imposed by signing of a WIC Vendor
Agreement prior to acceptance of any WIC check food
instrument. The two categories for which any potential vendor may apply are
grocery vendors and special purpose vendors.
a. Grocery vendor agreement. To qualify for a grocery vendor
agreement with the Iowa WIC program, a retail outlet shall meet all of the
following criteria:
(1) The vendor must be primarily a retailer of groceries
rather than of other merchandise such as gasoline, beverages, or snack foods. A
grocery retailer is defined as a business which stocks at least four of the
following categories of items: fresh produce (e.g., raw fruits and vegetables),
fresh or frozen meats and poultry (prepackaged luncheon meats do not qualify),
canned and frozen vegetables, dairy products, cereals and breadstuffs.
(2) The vendor must maintain regular business hours. This
shall include a minimum of two 4–hour blocks of time on each of five days
per week. Daily operating hours shall be consistent from week to week, and
shall be posted.
(3) The vendor must stock the following varieties and minimum
quantities of WIC approved foods:
1. A minimum of two boxes of each of six varieties of cold,
ready–to–eat cereals and two boxes of one variety of hot cereal from
the current WIC approved food list.
2. A minimum of fifteen 46–ounce containers of 100
percent fruit or vegetable juice and ten 12–ounce containers of
frozen concentrated 100 percent fruit or vegetable juice
from the current WIC approved food list. This shall include an assortment of at
least three approved canned or bottled (plastic only) varieties of orange,
pineapple, grapefruit, apple, grape, vegetable, or tomato, and two
frozen concentrated varieties of orange, pineapple,
grapefruit, grape or apple.
3. A minimum of four gallons of whole fluid milk and four
gallons of either low–fat, reduced fat, or fat–free fluid milk, and
two 1–pound packages each of two approved varieties of
cheese. two pounds each of at least two different varieties of
approved cheese in packages weighing one pound or less.
4. A minimum of two 1–pound bags of edible dried beans
or peas, any variety.
5. A minimum of two containers, 18–ounce size or less,
of 100 percent peanut butter.
6. A minimum of five dozen large fresh eggs, white or
brown.
7. A minimum of four pounds of raw full–size or baby
carrots.
8. A minimum of eight cans of tuna, 6–ounce minimum
size.
9. Upon request by a participant, a minimum of 31 cans
of 13–ounce concentrated infant formula as specified, or the equivalent
amount of powdered formula, plus 24 ounces of dry infant
cereal.
9. A minimum of six cans of any current rebate contract
powdered formula.
10. A minimum of twenty–four 13–ounce cans of
any current rebate contract concentrated formula.
11. A minimum of 24 ounces of WIC approved dry infant
cereal.
The specific brands of products that are included on the WIC
approved food list shall be made available to the vendor at the time of
application and prior to renewal of each agreement.
The variety and quantity in stock are defined as including
both inventory on display and in on–premises storage, but not inventory on
order from suppliers.
(4) A vendor shall charge a price to WIC participants that is
equal to or less than the price charged to all other customers. The prices
charged to WIC participants for the average of all WIC items, as reported on the
application, at the time of on–site review, and throughout the agreement
period, shall not exceed 105 percent of the average prices of all other WIC
vendors in the same city or metropolitan area. For purposes of the
comparison, a metropolitan area is defined as including the principal city or
cities and all contiguous incorporated areas peer group.
The vendor’s average price for any category of WIC items, as reported
on the application, at the time of the on–site review, and throughout the
agreement period, shall not exceed 115 percent of the average for the same
category by all other WIC vendors in the city or metropolitan
area same peer group. Categories refer to the groupings of
items identified in subparagraph (3), “1” to
“9 11.” For purposes of making the price
comparisons, the average price for all other WIC vendors in the
area peer group shall be computed from the most recent
Price Assessment Reports on file from those vendors. If a vendor intends to
comply with this provision by charging WIC participants a lower price than the
price charged to other customers, the WIC price for each approved item must be
identified on the package or shelf front.
(5) There must be a minimum of five current WIC participants
residing in the same ZIP code area as the vendor.
(6) The vendor must not have had a food stamp program
disqualification or civil monetary penalty imposed within the 12 months
preceding the date of the application or reauthorization.
(7) The vendor must not have had a WIC program suspension
imposed or a WIC application denied within the six–month period preceding
the date of the application.
(8) The vendor must accept training on WIC program regulations
prior to signing an agreement and must agree to provide training to all
employees who will handle WIC food checks instruments
prior to accepting any checks food
instruments.
(9) The vendor must agree to adhere to all provisions of the
WIC Grocery Vendor Instructions and Agreement
and Instruction Booklet.
b. Special purpose vendor. To qualify as a special purpose
vendor, a retail outlet shall meet all of the following criteria:
(1) The vendor may be primarily a retailer of any type of
merchandise but shall be authorized to provide only specified infant formula in
exchange for WIC food checks instruments.
(2) The vendor must be able to provide the specified formula
within 48 hours; 72 hours if a weekend or holiday is involved.
(3) The prices charged WIC participants must be equal to or
less than the prices charged all other customers. The average price of each
brand of infant formula sold to WIC participants as reported must not exceed the
average price of the same brands of infant formula charged by all authorized WIC
grocery vendors in the same city or metropolitan area, as defined
above peer group.
(4) The vendor shall meet the criteria in paragraph
“a,” subparagraphs (2), (5), (6), (7), and (8), for
grocery vendors as specified above.
(5) The vendor must agree to adhere to applicable provisions
of the WIC Special Purpose Vendor Instructions and
Agreement and Instruction Booklet.
The department shall review each vendor application within
five working days of receipt and determine if the information provided indicates
that the retail outlet meets the selection criteria. If the application shows
that the vendor does not meet one or more of the criteria, the department shall
deny the application. If the vendor’s application indicates that the
vendor would qualify, the department or contract agency shall make an
on–site visit to verify that the information provided in the application
is correct, to provide training, and sign the agreement. If the department
or contract agency finds that the vendor has two or more types of
out–of–date, stale, or moldy WIC foods in stock during the
on–site visit, the vendor’s application may be denied. If the
contract agency or department determines during the on–site visit that the
vendor does not qualify, the contract agency or department shall not sign the
agreement. Within five working days of disapproving an application or
agreement, the department will advise the vendor in writing of the reasons for
denial of the application and the procedure for appeal. During the
on–site visit, the contract agency representative is acting as an agent of
the department and has the authority to approve or deny an
application.
A vendor that is denied an agreement, either at the
application review level or at the on–site review, is required to wait six
months prior to submitting a new application. The department may, at its
discretion, request a vendor to resubmit an application prior to completing its
review if the application has not been completed to the extent that a
determination of eligibility can be made.
c. Reauthorization. If ownership of an authorized vendor
changes during the agreement period, the agreement becomes void. The new owner
must file an application and be approved prior to accepting WIC
checks food instruments. Vendor agreements are valid
only for the period of time specified, and a vendor may not continue accepting
checks food instruments past the expiration date unless
a new agreement is signed. When a currently authorized vendor makes application
for a subsequent agreement, an agreement shall be signed only if the vendor
has a score of at least 40 review points. A vendor that meets the
minimum qualifications for new vendors is awarded 100 review points. Points
assessed during the previous 24 months for administrative and procedural
violations under 73.19(2)“b” are then subtracted to determine the
final score. has been assessed less than 60 violation points under
paragraph 73.19(2)“b” within the previous 24 months.
Vendors with a current WIC agreement are not required to
complete a new written application each year if the information in their
original application is substantially unchanged. The department may request a
new application from any vendor prior to offering a new agreement if it has
reason to believe the information in the original is no longer correct or the
vendor may no longer be eligible for an agreement.
The department shall send the vendor written notice at least
30 days prior to the expiration of the agreement that it does not intend to
offer the vendor a new agreement if the minimum review points are not met or if
any of the following conditions are in effect:
1. The vendor has failed to submit any of the preceding
year’s Price Assessment Reports by the specified dates.
2. The vendor has not cashed any WIC checks
food instruments for at least two consecutive months. This provision
does not apply to special purpose vendors.
3. Any of the selection criteria listed in
73.8(4)“a” and “b” above are no longer met.
Expiration of a WIC agreement is not subject to appeal. A
vendor who is not offered a new agreement by the department has the right to
file a new application. If that application is denied, the vendor has the right
to appeal.
Contract agencies are responsible for providing training
regarding all changes in program regulations and determining that all of the
selection criteria are still met prior to signing a new agreement. If the
contract agency denies a new agreement, the vendor has the right to appeal
without first submitting an application.
d. Training. Vendors shall accept training in program
policies and procedures at the on–site review prior to becoming an
authorized vendor and shall be responsible for training all employees who will
be handling WIC checks food instruments. The manager
and person responsible for staff training must allow time at this visit for
training; the agreement will not be signed until training is completed. Vendors
shall be responsible for all actions of their employees in conducting WIC
transactions.
If violations of program policies and procedures are
documented, either through on–site monitoring or other indirect means, the
vendor shall implement a corrective action training plan developed jointly by
the vendor and the department or contract agency.
e. Validity of checks food
instruments. The WIC vendor shall be responsible for ensuring
that:
(1) The participant countersignature required on the food
check instrument is completed in the vendor’s
presence, and that both signatures on the food check
instrument match;
(2) The participant presents a WIC identification card prior
to redeeming checks food instruments for
food;
(3) The type and quantity of food to be purchased is as
indicated on the checks food instrument;
(4) The amount of money written onto the
check food instrument for repayment does not exceed the
maximum amount as designated by the department and printed on the
check food instrument;
(5) The expiration date is present on the
check food instrument and is equal to or no later than
the date of usage;
(6) WIC checks food instruments are
never exchanged for cash or credit;
(7) Substitutions of foods different from those listed on the
check food instrument in type or amount are not
made;
(8) Checks Food instruments are
presented to the state’s agent (bank) for payment within 15 days of the
date of receipt;
(9) The costs of foods purchased by WIC participants do not
exceed charges to other customers for the same foods;
(10) The vendor’s authorizing number is stamped with the
state–issued vendor stamp on the face of the check
food instrument prior to its being presented for payment.
f. and g. No change.
ITEM 6. Amend subrule 73.8(5) as
follows:
73.8(5) Vendor monitoring. To maintain program
integrity and accountability for federal or state program funds, the department
and contract agencies shall conduct ongoing monitoring of authorized vendors,
both through on–site visits and through indirect means. A random sample of
10 percent of currently authorized vendors receives on–site
monitoring every year. Vendors that change ownership during the year, or apply
during the contract period, receive an on–site visit prior to signing an
agreement. The types of on–site monitoring are defined as
follows:
a. Routine or representative monitoring is used for vendors
for which there is no record of violations or complaints or other indication of
problems. It may include any or all of the following: use of a
check food instrument or observation of a participant,
educational buys, review of inventory levels, examination of redeemed WIC food
checks instruments on hand, review of store policies on
return items, and review of employee training procedures. The results of the
monitoring are reviewed with the owner or manager on duty, and afollow–up
letter confirming the findings is sent from the department. Routine monitoring
may be performed by the department or by contract agency staff under the
direction of the department. Depending on the nature and severity of violations
noted, the department may schedule additional visits, initiate a compliance
investigation, or apply sanctions.
Educational buy monitoring is a specialized type of routine
monitoring and may include gathering the same information. In addition,
department or contract agency staff attempt to use a WIC check
food instrument to purchase unauthorized types or brands of foods to test
the level of training of store employees. At the conclusion of the transaction,
the results of the buy are discussed with the store owner or manager on duty.
The transaction is then voided, and the merchandise returned to the shelves.
Educational buys are used on authorized vendors, selected by the department. If
unauthorized items are allowed to be purchased, the vendor shall agree to a
corrective action training plan. A follow–up educational buy is scheduled
within 30 to 90 days. A letter is sent from the department documenting the
violation. By signing a WIC agreement, a vendor gives consent for educational
buys by the department or contract agency. Vendors are not notified in advance
that an educational buy is scheduled. The protocol for educational buys,
including procedures, appropriate items to purchase, and forms to be used, is
specified in the Iowa WIC Policy and Procedure Manual.
b. No change.
c. High–risk monitoring is used for vendors that have
a documented record of problems such as previous violations, participant
complaints, or high volume of WIC food check redemption been
identified as high–risk according to the Iowa WIC Policy and Procedure
Manual. It includes, but is not limited to, any or all of the following:
review of inventory levels, examination of redeemed WIC food
checks instruments on hand, examination of electronic
monitoring indicators, volume of WIC redemptions, number of identified errors,
participant complaints, and review of store policies on returned items.
High–risk monitoring may be performed by the department or by contract
agency staff under the direction of the department. Educational buying shall be
included whenever possible.
d. Compliance buys may be used for any vendors. Compliance
buys include covert activities used to document grounds for suspension from the
program and may include purchase attempted
purchases of unauthorized items. Compliance buys may be performed by the
department or another state agency or private company under contract with the
department. The department is responsible for identifying the vendors to be
investigated and for approving the protocol to be used by the other
agency or company during the investigation. Upon completion of
a compliance buy documenting program violations, the department shall issue the
vendor a notice of violation points assessed or suspension.
The department also monitors vendor performance through
in–office review of information. Such information, specifically the total
amount of WIC redemptions, is confidential as provided for in Iowa Code section
22.7(6). This business information could provide an advantage to competitors
and would serve no public purpose if made available.
ITEM 7. Amend subparagraph
73.9(2)“c”(1) as follows:
(1) Administrative adjustments. No sliced, shredded,
or grated, or string cheese is provided due to cost
and possible confusion with imitation or processed cheese products.
Approved fluid single–strength juice shall be
packaged in a 46–ounce container. Approved frozen
concentrated juice shall be packaged in a 11.5–
or 12–ounce container containers.
The food package is adjusted to accommodate the special needs
of homeless and transient participants. Nonrefrigerated orange or grapefruit
juice in small serving containers may be provided. The reason for providing
single–serving containers must be documented in the nutrition care plan.
No tuna in cans containing less than six ounces is allowed due to cost. No
frozen or canned carrots will be allowed in the enhanced food package for
breast–feeding women. Fresh carrots will be provided due to their
widespread availability and acceptability.
ITEM 8. Amend subrule 73.9(3),
paragraph “c,” as follows:
c. Changes to the approved food list are made once a
year biennially, taking effect on October 1 in years when new
vendor contracts are signed. Inquiries from food companies about new and
continuing products must be received annually between November 1
and prior to February 1 of the year vendor contracts
expire to be guaranteed consideration.
ITEM 9. Amend paragraph
73.9(3)“d,” subparagraph (4), as follows:
(4) Ready–to–eat cold cereals are ranked by the
six major distributors to Iowa WIC vendors based on volume of total sales. Hot
cereals are ranked in the same way. Multiple varieties of a single brand of
cereal shall be considered as one brand for the purposes of constructing this
ranking. The state office compiles data from all distributors to develop an
overall ranking or ranked list. The top 19 16
name–brand cold cereals, the top 3 varieties of private–label
(store) brand cold cereals, and the top 2 hot cereals that qualify are
selected. This process includes both name–brand and
private–label cereals.
ITEM 10. Amend paragraph
73.9(3)“e” as follows:
e. Juices shall meet the federal guidelines for vitamin C
content and all of the following conditions:
(1) Juices shall be 100 percent juice and contain no added
sugar, sweeteners or artificial sweeteners.
(2) Fluid Single–strength juice
shall be packaged in a 46–ounce container. Frozen
Concentrated juice shall be marketed in 11.5– or
12–ounce containers.
(3) The brand shall be carried by one of the six largest
distributors in the state. Juices are ranked by the six major distributors
to Iowa WIC vendors based on volume of total sales. The top two name brands of
each flavor of juice (e.g., tomato, orange, grapefruit, grape, apple, or
blended) and form of juice (single–strength or concentrated) that meet the
selection criteria will be approved. Any private–label (store) brands
from the six major distributors that meet the selection criteria will also be
approved.
(4) The product form and marketing approach shall be
consistent with the promotion of good nutrition and education.
(5) If a group of juices from one manufacturer have similar
names and package designs and some do not qualify, the department reserves the
right to not approve those types that would otherwise qualify, to reduce the
potential for confusion by retail vendors and participants.
Canned Single–strength and frozen
concentrated varieties of juice with the same brand name will be
evaluated separately.
(6) Calcium–fortified juices shall not be
approved.
(7) Product shall have been available in retail stores in Iowa
for one year prior to the effective date of inclusion in the approved food
list.
(8) Frozen Concentrated juices must be
single flavors of juice.
ITEM 11. Amend paragraph
73.9(3)“f,” subparagraph (3), as follows:
(3) All brands of natural cheese qualify. The cheese shall be
in block or string form (not shredded, sliced, or grated
or string) and shall have no added flavors (e.g., smoke
flavoring, peppers, or wine).
ITEM 12. Amend subrule 73.12(1) as
follows:
73.12(1) Right of appeal. A local agency or a
vendor shall have a right to appeal when a local agency’s or
vendor’s application to participate is denied. The right to
appeal shall be granted when a local agency’s or a vendor’s
application to participate is denied. The right to appeal shall also be granted
when, during the course of the contract or agreement period, a local agency or
vendor is disqualified or any other action which affects participation is
taken. For participating vendors, a minimum of 30 days’ advance
notice will be given before the effective date of the action. For participating
contract agencies, a minimum of 60 days’ advance notice will be given
before the effective date of the action. The right to appeal shall not be
granted in the following circumstances:
a. When a vendor’s contract expires.
b. When the department makes a determination regarding
participant access.
c. When a vendor is disqualified from the WIC program as a
result of a food stamp program disqualification.
ITEM 13. Amend subrule 73.19(1) by
replacing the word “check” or “checks” with “food
instrument” or “food instruments,” respectively.
ITEM 14. Amend subrule 73.19(2) as
follows:
73.19(2) Vendor violations. There are three types of
sanctions that are applied to vendors for violations of program regulations:
nonpayment of checks food instruments, issuance of
violation points, and suspensions.
a. Nonpayment of checks food
instruments.
(1) As a result of prepayment reviews conducted by the
state’s bank, improperly completed food items are refused payment and
returned to the vendor. Items screened during prepayment are authorized vendor
stamp not present or legible in the “Pay to the Order of:” box on
face of check food instrument, missing or mismatched
signature and countersignature, price exceeds maximum printed on face of
check food instrument.
(2) If the violation can be corrected by applying the
authorized stamp, obtaining the proper countersignature, or reducing the price,
the item may be resubmitted for payment. Federal banking regulations prohibit a
financial instrument from being sent through the federal reserve system more
than twice. If an improperly completed WIC check food
instrument is received by the state’s bank a second time, it is voided
and may not be redeposited.
b. Administrative and procedural violation points.
Administrative and procedural violations are offenses to the provisions of the
WIC vendor agreement that do not rise to the level of fraud against the program
or its participants.
These violations are an indication of a vendor’s
inattention to or disregard of the requirements of a WIC vendor agreement. It
is in the department’s interest to record and consider these violations
when considering whether to continue its contractual relationship with the
vendor.
Vendors are assessed violation points, which are applied as
demerits against the vendor’s score in the subsequent procurement for WIC
vendor agreements in the vendor’s area.
In addition, the accumulation of 45 violation points within
the first year or 90 violation points within a single agreement period is a
major violation subject to a one–year suspension of the WIC agreement for
that vendor.
The assignment of violation points does not limit the
department’s right to effect stronger penalties and sanctions, in cases in
which there is evidence of an intentional or systematic practice of abusing or
defrauding the Iowa WIC program.
Violation
|
Points Per
Event
|
1.
|
Accepting five checks food instruments
over 30 days old within the agreement period.
|
5
|
2.
|
Redeeming five checks food instruments
more than 15 days after receipt within the agreement period.
|
5
|
Violation
|
Points Per
Event
|
3.
|
Accepting five checks food instruments
with no date stamp within the agreement period.
|
5
|
4.
|
Refusal to accept valid WIC checks food
instruments from participants.
|
10
|
5.
|
Abusive or discriminatory treatment of WIC participants, such
as requiring WIC participants to use special checkout lanes or provide extra
identification.
|
10
|
6.
|
Insufficient number of brands or types in a single food
group.
|
5
|
7.
|
Insufficient quantity of a single food group.
|
5
|
8.
|
No stock in a single food group.
|
5
|
9.
|
Insufficient number of brands or types in two food
groups.
|
10
|
10.
|
Insufficient quantity in two food groups.
|
10
|
11.
|
No stock in two or more food groups.
|
10
|
12.
|
Insufficient number of brands or types in three or more food
groups.
|
10
|
13.
|
Insufficient quantity in three or more food groups.
|
15
|
14.
|
No stock in three or more food groups. (For 6 to 14, food
groups are as
defined in 73.8(4)“a”(3).)
|
15
|
15.
|
Failure to carry out corrective action plan developed as a
result of monitoring visit.
|
10
|
16.
|
Allowing the purchase of similar but not approved
foods.
|
10
|
17.
|
Failure to reimburse department for potentially overpaid
check food instrument or provide reasonable explanation
for the cost of the check food instrument.
|
5
|
18.
|
Accepting the return of food purchased with WIC
checks food instruments for cash or credit toward other
purchases.
|
10
|
19.
|
Using a WIC vendor stamp other than the one issued by the Iowa
WIC program.
|
5
|
20.
|
Providing a brand of formula other than the one specified on
the check food instrument.
|
10
|
21.
|
Issuing “rain checks” or credit in exchange for
WIC checks food instruments.
|
10
|
22.
|
Stocking out–of–date, stale, or moldy WIC foods,
per type.
|
10
|
23.
|
Failure to submit vendor price assessment reports as
requested.
|
10
|
24.
|
For vendors that have special WIC prices, failure to post WIC
prices on the shelf or on the package.
|
15
|
25.
|
Failure to complete check food
instrument properly, including filling in correct amount and date of
purchase, and verifying matching signatures.
|
15
|
Violation
|
Points Per
Event
|
26.
|
Contacting WIC participants in an attempt to recover funds not
paid by WIC.
|
15
|
27.
|
Charging prices to WIC participants that are more than 105
percent of the
average prices of all other WIC vendors in the same
city or metropolitan area peer group.
|
15
|
28.
|
Providing false information on the price assessment
report.
|
15
|
29.
|
Failure to train all employees and ensure their knowledge
regarding WIC
program procedures set forth in the vendor’s current
agreement and in the
current publication of the Iowa WIC program’s vendor
instruction booklet.
|
10
|
30.
|
Requiring WIC participant to purchase a particular brand when
other WIC approved brands are available.
|
10
|
31.
|
Not allowing WIC participants to use discount coupons or
promotional
specials to reduce the WIC check food
instrument amount.
|
10
|
32.
|
Requiring other cash purchases to redeem WIC
checks food instruments.
|
15
|
33.
|
Failure to allow purchase of up to the full amount of WIC
foods authorized on the check food instrument if such
foods are available and desired by the WIC participant.
|
20
|
c. Suspensions for chronic violations, fraud, or
abuse. With an administrative finding of the
following violations, the vendor will be suspended for one year.
Items 1 to 6 are Class I offenses and result in a
one–year suspension. Items 7 to 14 are Class II offenses and result in a
two–year suspension. Items 15 to 17 are Class III offenses and result in
a three–year suspension.
1. Accumulation of 45 or more violation points within
the first year or 90 or more violation points within a single agreement
period.
2. Allowing purchase of nonapproved and nonsimilar food items
in exchange for WIC checks food instruments.
3. Failure to provide access to store premises or in any
manner to hinder, impede or misinform authorized WIC personnel in the act of
conducting an on–site education, monitoring or investigation
visit.
4. Loss of Iowa department of inspections and appeals
license.
5. Violation of the rules and provisions of the USDA
Food Stamp Program or other state WIC program, resulting in a loss of vendor
authorization or in a civil monetary penalty. The suspension period for such
offenses shall equal the time period of disqualification from the other USDA
program or one full year, whichever is greater.
6 5. Submitting for payment a WIC
check food instrument redeemed by another authorized
vendor.
7. Charging WIC participants more than non–WIC
customers or charging WIC participants more than the current shelf
price.
8. Charging for items not received by the WIC
participant or for foods provided in excess of those listed on the
check.
9. Allowing purchase of nonfood items with a WIC
check.
10. Receiving, transacting or redeeming WIC checks
outside of authorized channels.
11. Claiming reimbursement for the sale of a quantity
of a specific food item which exceeds the store’s documented inventory of
that food item for a specified period of time.
12. Accepting WIC food checks from unauthorized
persons.
13 6. Threatening or verbally abusing
WIC participants or authorized WIC program personnel in the conduct of
legitimate WIC program transactions.
14. Two or more incidents of Class I violations within
a single agreement period (whether or not the first instance resulted in a
sanction).
15. Trafficking or exchanging cash or credit for WIC
checks.
16. Submission for payment of WIC checks known to have
been lost or stolen.
17. Participation with other individuals including but
not limited to WIC employees, vendors, and participants, in systematic efforts
to submit false claims for reimbursement of improper WIC
checks.
d. With an administrative finding of the following
violations, the vendor will be suspended for three years.
1. A pattern of charging WIC participants more than
non–WIC customers or charging WIC participants more than the current shelf
price.
2. A pattern of charging for items not received by the WIC
participant or for foods provided in excess of those listed on the WIC food
instrument.
3. A pattern of providing credit or nonfood items, except
for alcohol, alcoholic beverages, or tobacco products, in exchange for WIC food
instruments.
4. One incidence of allowing the purchase of alcohol,
alcoholic beverages, or tobacco products with a WIC food
instrument.
5. A pattern of receiving, transacting, or redeeming WIC
food instruments outside authorized channels, including through unauthorized
vendors or persons.
6. A pattern of claiming reimbursement for the sale of a
quantity of a specific food item which exceeds the store’s documented
inventory of that food item for a specified period of time.
7. Submission for payment of WIC food instruments known by
the vendor to have been lost or stolen.
e. With an administrative finding of the following
violations, the vendor will be suspended for six years.
1. One incidence of buying or selling food instruments for
cash (trafficking).
2. Participating with other individuals including but not
limited to WIC employees, vendors, and participants, in systematic efforts to
submit false claims for reimbursement of improper WIC food
instruments.
3. One incidence of selling firearms, ammunition,
explosives, or controlled substances (as defined in Section 102 of the
Controlled Substances Act (21 U.S.C. 802)), in exchange for WIC food
instruments.
f. With a conviction in a criminal court of law for
trafficking in WIC food instruments or selling firearms, ammunition, explosives,
or controlled substances (as defined in Section 102 of the Controlled Substances
Act (21 U.S.C. 802)) in exchange for WIC food instruments, the vendor will be
permanently disqualified from the Iowa WIC program. The department may impose a
civil money penalty (CMP) in lieu of a disqualification when it determines, in
its sole discretion, that:
1. Disqualification of the vendor would result in
inadequate participant access; or
2. The vendor had, at the time of the violation, an
effective policy and program in effect to prevent trafficking; and the ownership
of the vendor was not aware of, did not approve of, and was not involved in the
conduct of the violation.
d g. The following items do not have a
point value, but shall result in or extend a suspension period:
1. Failure to return WIC vendor stamp(s) to the WIC program
within ten days of effective date of suspension, or expiration of agreement
following denial of subsequent application, shall result in a 30–day
extension of a suspension period.
2. Failure to submit a WIC price assessment report
after the second request will result in termination of the
agreement.
3 2. For each month in which a vendor
accepts WIC checks food instruments during a suspension
period, the suspension period shall be extended by 30 days.
e h. The above sanctions
notwithstanding, the state of Iowa reserves the right to seek civil and criminal
prosecution of WIC vendors for any and all instances of dealing in stolen or
lost checks food instruments, trading cash and other
inappropriate commodities for checks food instruments,
or cases in which there exists evidence of a clear business practice to
improperly obtain WIC funds, or other practices meeting the definition of fraud
as defined in 7 CFR 246 or the Iowa Code.
i. A vendor shall not be entitled to receive any
compensation for revenues lost as a result of any suspension or permanent
disqualification.
f j. A minimum of 15 days’
notice is provided prior to all suspensions, except for permanent
disqualifications assessed under paragraph 73.19(2)“f,” which are
effective on the date of receipt of the notice of administrative action.
When the department determines that a Class I, II, or III
an offense has occurred, a suspension letter with supporting
documentation is prepared for the WIC director’s signature. The
suspension letter identifies the specific offense
offenses from paragraph “c” of this subrule
that the vendor is charged with and the procedures for filing an
appeal.
g k. The department is responsible for
issuing all warning and suspension letters. Contract agencies are informed of
all vendor correspondence regarding violations. In situations where participant
violations are also involved, the contract agency is responsible for
follow–up, as detailed in subrule 73.19(1).
h l. Federal food stamp regulations
require automatic disqualification from the food stamp program for vendors
suspended by the WIC program for certain types of violations. When a vendor
is suspended from the WIC program, the suspension letter to the vendor will
include the following statement: “This disqualification from WIC may
result in disqualification as a retailer in the food stamp program. Such
disqualification may not be subject to administrative or judicial review under
the food stamp program.” For offenses numbered 7, 8, 9, 10,
11, 12, and 15 in paragraph “c” above, all vendor
disqualifications from the WIC program, notice will be sent to the United
States Department of Agriculture for appropriate action.
i m. The department shall disqualify a
vendor who has been disqualified from the food stamp program. The
disqualification shall be for the same length of time as the food stamp program
disqualification, may begin at a later date than the food stamp program
disqualification, and shall not be subject to administrative or judicial review
under the WIC program. If the department determines that disqualification of
a vendor would result in inadequate participant access, it will impose a civil
money penalty (CMP) in lieu of disqualification.
j. The department shall permanently disqualify a
vendor convicted of trafficking in food instruments or selling firearms,
ammunition, explosives, or controlled substances (as defined in Section 102 of
the Controlled Substances Act(21 U.S.C. 802)) in exchange for food instruments.
A vendor shall not be entitled to receive any compensation for revenues lost as
a result of such violation. The department may impose a civil money penalty
(CMP) in lieu of a disqualification for this violation when it determines, in
its sole discretion, and documents in accordance with the Federal Register,
Volume 64, Number 52, Thursday, March 8, 1999, paragraph 246.12(k)(8)
that:
(1) Disqualification of the vendor would result in
inadequate participant access; or
(2) The vendor had, at the time of the violation, an
effective policy and program in effect to prevent trafficking; and the ownership
of the vendor was not aware of, did not approve of, and was not involved in the
conduct of the violation.
k n. Civil money penalties.
1. The department When the
department determines that a civil money penalty (CMP) shall be imposed in lieu
of disqualification for reasons specified under paragraph
73.19(2)“f” or 73.19(2)“m,” it shall use the
civil money penalty formula in accordance with the Federal Register,
Volume 64, Number 52, Thursday, March 8, 1999, paragraph 246.12(k)(8)
Title 7 CFR Subpart 246.12(k)(1)(x) to determine the CMP.
2. If a vendor does not pay, only partially pays, or fails
to timely pay a CMP, the department will disqualify the vendor for the length of
the disqualification corresponding to the violation for which the CMP was
assessed. “Failure to timely pay a CMP” includes the failure to pay
a CMP in accordance with an installment plan approved by the
department.
l 3. Money received by the state WIC
agency as a result of civil money penalties or fines assessed against a vendor
and any interest charged in the collection of these penalties and fines shall be
considered as program income.
ITEM 15. Amend rule 641—73.20(135)
as follows:
641—73.20(135) Data processing. All contract
agencies shall comply with the instructions outlined in the Iowa WIC Policy and
Procedure Manual for use of the automated data processing system in provision of
WIC checks food instruments and monitoring of WIC
services. No contract agency is exempted from adherence to any portion of these
instructions.
PUBLIC SAFETY
DEPARTMENT[661]
Public Notice
Pursuant to the authority of Iowa Code section 13.10 and 61
IAC 8.6(13), the Department of Public Safety hereby gives public notice that the
Division of Criminal Investigation Criminalistics Laboratory is prepared to
process samples of DNA collected pursuant to Iowa Code section 13.10 and
61—Chapter 8. Therefore, 61—Chapter 8 is effective immediately upon
publication of this notice in the Iowa Administrative Bulletin, as provided in
61 IAC 8.6(13).
ARC 9617A
TRANSPORTATION
DEPARTMENT[761]
Notice of Intended Action
Notice is also given to the public that the
Administrative Rules Review Committee may, on its own motion or on written
request by any individual or group, review this proposed action under section
17A.8(6) at a regular or special meeting where the public or interested persons
may be heard.
Pursuant to the authority of Iowa Code sections 307.10 and
307.12, the Department of Transportation hereby gives Notice of Intended Action
to amend Chapter 10, “Administrative Rules and Declaratory Orders,”
Chapter 112, “Primary Road Access Control,” Chapter 115,
“Utility Accommodation,” Chapter 524, “For–Hire
Intrastate Motor Carrier Authority,” and Chapter 529,
“For–Hire Interstate Motor Carrier Authority,” and to adopt
Chapter 11, “Waiver of Rules,” Iowa Administrative Code.
These amendments adopt the waiver rule required by Executive
Order Number 11 and make coordinating amendments.
Any person or agency may submit written comments concerning
these proposed amendments or may submit a written request to make an oral
presentation. The comments or request shall:
1. Include the name, address, and telephone number of the
person or agency authoring the comments or request.
2. Reference the number and title of the proposed rule, as
given in this Notice, that is the subject of the comments or request.
3. Indicate the general content of a requested oral
presentation.
4. Be addressed to the Department of Transportation,
Director’s Staff Division, 800 Lincoln Way, Ames, Iowa 50010; fax
(515)239–1639; Internet E–mail address: rules@
iadot.e–mail.com.
5. Be received by the Director’s Staff Division no later
than February 15, 2000.
A meeting to hear requested oral presentations is scheduled
for Thursday, February 17, 2000, at 1 p.m. in the Commission Conference Room of
the Department of Transportation, 800 Lincoln Way, Ames, Iowa.
The meeting will be canceled without further notice if no oral
presentation is requested.
These amendments are intended to implement Iowa Code chapter
17A and Executive Order Number 11, dated September 14, 1999.
Proposed rule–making actions:
ITEM 1. Amend subrule 10.1(2),
definition of “Written criticisms,” numbered paragraph
“2,” as follows:
2. Petitions for waiver of a rule tendered to the department
or granted by the department under 761—Chapter 11.
ITEM 2. Adopt the following
new chapter:
CHAPTER 11
WAIVER OF RULES
761—11.1(17A) Purpose and scope.
11.1(1) The purpose of this chapter is to establish
generally applicable standards for granting waivers of department rules, the
form for petitioning the department to grant waivers using these standards, and
the procedure for acting upon such petitions.
11.1(2) This chapter does not preclude the granting of
waivers using other standards, forms and procedures if a statute or other
department rule so provides. If the rule for which a waiver is sought has a
specific waiver provision of its own, this chapter is applicable only when it is
specifically cited.
11.1(3) This chapter does not apply to contested case
proceedings.
11.1(4) This chapter does not apply to rules that
merely define the meaning of a statute or other provision of law if the
department does not possess the delegated authority to bind the courts to any
extent with its definition.
761—11.2(17A) Standards.
11.2(1) The director of transportation may, on the
director’s own motion, issue an order granting a waiver of a rule, in
whole or in part, for a class of persons if the director finds that the waiver
would confer a benefit or remove a restriction on that class of persons and that
the waiver would be consistent with the public interest.
11.2(2) The director of transportation may, on the
director’s own motion or in response to a written petition, issue an order
granting a waiver of a rule, in whole or in part, as applied to the
circumstances of a specified person, if the director finds that:
a. Application of the rule to that person would result in
undue hardship or injustice to that person,
b. Waiver of the rule on the basis of the circumstances of
that person would be consistent with the public interest, and
c. Waiver of the rule would not prejudice the substantial
legal rights of any person.
11.2(3) In response to a written petition requesting a
waiver, the director of transportation shall issue an order granting a waiver of
a rule, in whole or in part, as applied to the circumstances of a specified
person, if the director finds that application of all or a portion of the rule
to the circumstances of that person would not to any extent advance or serve any
of the purposes of the rule.
761—11.3(17A) Waiver considerations and
limitations.
11.3(1) In determining whether a waiver would be
consistent with the public interest, the director shall consider whether, if the
waiver were granted, the public health and safety will be protected by other
means that are substantially equivalent to full compliance with the
rule.
11.3(2) When the rule for which a waiver is sought
establishes an administrative deadline, the director shall balance the special
individual circumstances of the petitioner with the overall goal of uniform
treatment of all applicants or licensees.
11.3(3) A requirement created or duty imposed by
statute shall not be waived.
11.3(4) Any waiver granted must be consistent with
statute.
11.3(5) A rule may be waived only if the department
has exclusive rule–making authority to promulgate that rule.
761—11.4(17A) Petition for waiver.
11.4(1) Petitioner. A person may petition the
department for waiver of a rule only on the ground that application of that rule
to the circumstances of that person would justify a waiver under subrule 11.2(2)
or 11.2(3). The petitioner must have a real and direct interest in the matter.
The petitioner has the burden of persuasion.
11.4(2) Form of petition.
a. A petition for waiver of a rule must be in writing and
state clearly at the top of the petition that it is a petition for waiver of a
rule.
b. The body of a petition for waiver of a rule shall contain
the following information where applicable and known to the
petitioner:
(1) The name, address and telephone number of the
petitioner.
(2) A description of and citation to the specific rule from
which a waiver is requested.
(3) The specific waiver requested, including its precise scope
and operative period.
(4) The reasons for the requested waiver.
(5) The relevant facts supporting the requested waiver, and a
statement attesting to the accuracy of these facts.
(6) A history of the department’s actions relative to
the petitioner.
(7) Whether the petitioner is currently a party to a
rule–making, declaratory order, contested case or judicial proceeding
related to the requested waiver.
(8) Information regarding the department’s treatment of
similar situations.
(9) The name, address and telephone number of any public
agency or political subdivision that also regulates the activity in question or
that may be affected if the waiver were granted.
(10) The name, address and telephone number of any person or
entity who may be adversely affected if the waiver were granted.
(11) The name, address and telephone number of any person
inside or outside the department who has knowledge of the relevant facts related
to the requested waiver.
(12) The name, address and telephone number of the individual
who is the petitioner’s authorized representative regarding the
petition.
c. A petition for waiver of a rule shall be signed and dated
by the petitioner or the petitioner’s authorized representative.
d. If applicable, a petition for waiver of a rule shall be
accompanied by a separate release signed by the petitioner or the
petitioner’s authorized representative authorizing specific persons with
knowledge of the relevant facts related to the requested waiver to furnish that
information to the department.
11.4(3) Submission of petition. A petition for waiver
of a rule shall be submitted to the Director’s Staff Division, Department
of Transportation, 800 Lincoln Way, Ames, Iowa 50010.
761—11.5(17A) Procedure. Following is the
procedure for granting or denying a waiver upon petition:
11.5(1) The department shall acknowledge receipt of a
petition for waiver of a rule immediately.
11.5(2) Before a waiver is granted or denied, the
department may request a petitioner to furnish additional information related to
the petition.
11.5(3) The director shall issue a written order
granting or denying a waiver within 120 days after the department receives the
petition for waiver unless the petitioner agrees to a later time. However, if
the matter is also the subject of a contested case proceeding, the order need
not be issued until after the final decision in that contested case is
issued.
11.5(4) An order granting or denying a waiver shall
contain:
a. The name of the person to whom the order
pertains.
b. A citation to the rule or portion thereof to which the
order pertains.
c. The relevant facts upon which the decision is
based.
d. The reason(s) for granting or denying the waiver.
e. The precise scope and operative period of the waiver if one
is granted. The director may condition the granting of a waiver upon such
reasonable conditions as are appropriate to achieve the objectives of the rule
in question.
11.5(5) Within seven days after an order is issued,
the department shall transmit it to the petitioner.
11.5(6) Failure to grant or deny a waiver within the
required time is deemed a denial.
11.5(7) The director’s decision on a waiver is
final agency action.
11.5(8) A petition for waiver of a rule is independent
of a contested case proceeding. A petition for waiver of a rule does not delay
the time to request a contested case hearing, to appeal a proposed decision in a
contested case, or to file a petition for judicial review of a final decision in
a contested case.
11.5(9) A petition for waiver of a rule is not
required to exhaust administrative remedies before judicial review of a
department action under Iowa Code section 17A.19.
761—11.6(17A) Validity.
11.6(1) An order granting a waiver is a defense within
its terms for the person to whom the order pertains in any proceeding in which
the rule in question is sought to be invoked.
11.6(2) A waiver is void if the relevant facts upon
which the waiver is based are not true, if relevant facts have been withheld, or
if the petitioner has failed to comply with the conditions set forth in the
order granting the waiver.
761—11.7(17A) Records.
11.7(1) All orders issued under this chapter are open
rec–ords. However, if an order contains personal information that is
confidential, that information shall be deleted before the order is made
available for public inspection.
11.7(2) The department shall retain orders denying
waivers for five years. The department shall retain orders granting waivers for
five years or until there is no longer any need to retain them, whichever is
later. The orders are indexed by rule chapter.
These rules are intended to implement Iowa Code chapter 17A
and Executive Order Number 11, dated September 14, 1999.
ITEM 3. Amend subrule 112.1(2) as
follows:
112.1(2) The department reserves the right
to may make exceptions to these rules this
chapter where the exercise of sound and reasonable judgment indicates that
the literal enforcement of the rules this chapter would
cause an undue hardship to any interested party affected
person, the community or the state. 761—Chapter 11 is not
applicable except for rules 761—11.6(17A) and 761—11.7(17A). When
submitting an application, the applicant may submit a written request for an
exception. The request shall include an explanation of and justification for
the requested exception. The requested exception shall be evaluated as part of
the application.
ITEM 4. Amend subrule 115.1(2) as
follows:
115.1(2) The department reserves the right
to may make exceptions to this chapter where the exercise of
sound and reasonable judgment indicates that the literal enforcement of this
chapter would defeat its objectives. 761—Chapter 11 is not applicable
except for rules 761—11.6(17A) and 11.7(17A). When submitting an
application, the applicant may submit a written request for an exception. The
request shall include an explanation of and justification for the requested
exception. The requested exception shall be evaluated as part of the
application.
ITEM 5. Amend subrule 524.2(2) as
follows:
524.2(2) Waiver of rules. The director of the
motor vehicle division transportation may, in accordance with
761— Chapter 11, waive provisions of this chapter. In lieu of the
standards in rule 761—11.2(17A), the director may issue a waiver if the
director determines after determining that special or
emergency circumstances exist or that the waiver is in the best interest of the
public.
a. “Special or emergency
circumstances” means one or more of the following:
(1) 1. Circumstances where the
movement is necessary to cooperate with cities, counties, other state agencies
or other states in response to a national or other disaster.
(2) 2. Circumstances where the
movement is necessary to cooperate with national defense officials.
(3) 3. Circumstances where the
movement is necessary to cooperate with public or private utilities in order to
maintain their public services.
(4) 4. Circumstances where the
movement is essential to ensure safety and protection of any person or property
due to events such as, but not limited to, pollution of natural resources, a
potential fire or an explosion.
(5) 5. Circumstances where weather or
transportation problems create an undue hardship for citizens of the state of
Iowa.
(6) 6. Circumstances where movement
involvesemergency–type vehicles.
(7) 7. Uncommon and extraordinary
circumstances where the movement is essential to the existence of an Iowa
business and the move may be accomplished without causing undue hazards to the
safety of the traveling public or undue damage to private or public
property.
b. A request for a waiver must be submitted in writing
to the Director of the Motor Vehicle Division, Department of Transportation,
P.O. Box 9204, Des Moines, Iowa 50306– 9204.
c. The request should include the following
information where applicable and known to the requester:
(1) The name, address and motor carrier permit or
certificate number.
(2) The specific rule from which a waiver is
requested.
(3) The specific waiver requested.
(4) The reasons for the request.
(5) The relevant facts supporting the
request.
d. The request shall be acknowledged immediately and
shall be responded to in writing within 60 days of receipt.
e. The decision on the waiver is the final decision of
the department.
ITEM 6. Amend rule 761—529.3(327B)
as follows:
761—529.3(327B) Waiver of rules. The director
of the motor vehicle division transportation may, in
accordance with 761—Chapter 11, waive provisions of this chapter.
In lieu of the standards in rule 761—11.2(17A), the director may issue a
waiver if the director determines after determining that
special or emergency circumstances exist or the waiver is in the best interest
of the public for interstate travel through Iowa.
529.3(1) “Special or emergency
circumstances” means one or more of the following:
a 1. Circumstances where the movement
is necessary to cooperate with cities, counties, other state agencies or other
states in response to a national or other disaster.
b 2. Circumstances where the movement
is necessary to cooperate with national defense officials.
c 3. Circumstances where the movement
is necessary to cooperate with public or private utilities in order to maintain
their public services.
d 4. Circumstances where the movement
is essential to ensure safety and protection of any person or property due to
events such as, but not limited to, pollution of natural resources, a potential
fire or explosion.
e 5. Circumstances where weather or
transportation problems create an undue hardship for citizens of the state of
Iowa.
f 6. Circumstances where movement
involvesemergency–type vehicles.
g 7. Uncommon and extraordinary
circumstances where the movement is essential to the existence of an Iowa
business and the move may be accomplished without causing undue hazard to the
safety of the traveling public or undue damage to private or public
property.
529.3(2) A request for a
waiver must be submitted in writing to the Director of the Motor Vehicle
Division, Department of Transportation, P.O. Box 9204, Des Moines, Iowa
50306–9204.
529.3(3) The request should
include the following information where applicable and known to the
requester:
a. The name, address and motor carrier permit or
certificate number.
b. The specific waiver requested.
c. The reasons for the request.
d. The relevant facts supporting the
request.
529.3(4) The request shall be
acknowledged immediately and shall be responded to in writing within 60 days of
receipt.
529.3(5) The decision on the
waiver is the final decision of the department.
ARC 9622A
TRANSPORTATION
DEPARTMENT[761]
Notice of Intended Action
Notice is also given to the public that the
Administrative Rules Review Committee may, on its own motion or on written
request by any individual or group, review this proposed action under section
17A.8(6) at a regular or special meeting where the public or interested persons
may be heard.
Pursuant to the authority of Iowa Code sections 307.10 and
307.12, the Department of Transportation hereby gives Notice of Intended Action
to amend Chapter 452, “Flashing Lights and Warning Devices on
Slow–Moving Vehicles,” Iowa Administrative Code.
These amendments delete two obsolete rules and adopt a new
rule providing standards for an alternative reflective device for use on
horse– or mule–drawn vehicles. 1999 Iowa Acts, chapter 102, section
2, provides that an alternative reflective device may be used if the individual
operating the horse– or mule–drawn vehicle objects for religious
reasons to using a reflective device that complies with the standards of the
American Society of Agricultural Engineers. The alternative reflective device
must be in compliance with rules adopted by the Department.
The new rule provides for an alternative reflective device of
one–inch–wide reflective strips that outline the rear of the
vehicle. This new rule does not provide a waiver. Rather, the rule implements
a statutory waiver.
Any person or agency may submit written comments concerning
these proposed amendments or may submit a written request to make an oral
presentation. The comments or request shall:
1. Include the name, address, and telephone number of the
person or agency authoring the comments or request.
2. Reference the number and title of the proposed rule, as
given in this Notice, that is the subject of the comments or request.
3. Indicate the general content of a requested oral
presentation.
4. Be addressed to the Department of Transportation,
Director’s Staff Division, 800 Lincoln Way, Ames, Iowa 50010; fax
(515)239–1639; Internet E–mail address: rules@
iadot.e–mail.com.
5. Be received by the Director’s Staff Division no later
than February 15, 2000.
A meeting to hear requested oral presentations is scheduled
for Thursday, February 17, 2000, at 2 p.m. in the Commission Conference Room of
the Department of Transportation, 800 Lincoln Way, Ames, Iowa.
The meeting will be canceled without further notice if no oral
presentation is requested.
These amendments are intended to implement Iowa Code
Supplement section 321.383(2).
Proposed rule–making actions:
ITEM 1. Amend the title of
761—Chapter 452 as follows:
FLASHING LIGHTS AND WARNING
REFLECTIVE DEVICES ON SLOW–MOVING VEHICLES
ITEM 2. Rescind and reserve rules
761—452.1(321) and 761—452.2(321).
ITEM 3. Adopt the following
new rule:
761—452.3(321) Alternative reflective device.
If a person operating a vehicle drawn by a horse or mule objects for religious
reasons to using a reflective device that complies with the standards of the
American Society of Agricultural Engineers, the vehicle may be identified by an
alternative reflective device that is in compliance with the
following:
452.3(1) The alternative reflective device shall
consist of one–inch–wide strips applied to the rear of the vehicle.
The combined length of the strips shall be at least 72 inches. The strips, when
applied, shall approximate the outline of the vehicle.
452.3(2) The reflective material may be black, gray,
silver or white in color, but must reflect white when illuminated by other
vehicles’ headlamps.
452.3(3) The reflective material shall be visible from
a distance of not less than 500 feet from the rear of the vehicle when
illuminated by other vehicles’ headlamps.
452.3(4) The reflective material shall be kept free of
dirt and debris.
This rule is intended to implement Iowa Code Supplement
section 321.383(2).
NOTICE—PUBLIC FUNDS INTEREST
RATES
In compliance with Iowa Code chapter 74A and section 12C.6,
the committee composed of Treasurer of StateMichael L. Fitzgerald,
Superintendent of Credit Unions James E. Forney, Superintendent of Banking
Holmes Foster, and Auditor of State Richard D. Johnson have established today
the following rates of interest for public obligations and special assessments.
The usury rate for January is 8.00%.
INTEREST RATES FOR PUBLIC
OBLIGATIONS AND ASSESSMENTS
74A.2 Unpaid Warrants Maximum 6.0%
74A.4 Special Assessments Maximum 9.0%
RECOMMENDED for 74A.3 and 74A.7: A rate equal to 75%
of the Federal Reserve monthly published indices for U.S. Government securities
of comparable maturities.
The rate of interest has been determined by a committee of the
state of Iowa to be the minimum interest rate that shall be paid on public funds
deposited in approved financial institutions. To be eligible to accept deposits
of public funds of the state of Iowa, a financial institution shall demonstrate
a commitment to serve the needs of the local community in which it is chartered
to do business. These needs include credit services as well as deposit
services. All such financial institutions are required to provide the committee
with a written description of their commitment to provide credit services in the
community. This statement is available for examination by citizens.
New official state interest rates, effective January 11, 2000,
setting the minimums that may be paid by Iowa depositories on public funds are
listed below.
TIME DEPOSITS
7–31 days Minimum 5.00%
32–89 days Minimum 5.20%
90–179 days Minimum 5.40%
180–364 days Minimum 5.50%
One year Minimum 5.60%
Two years or more Minimum 5.90%
These are minimum rates only. The one year and less are
four–tenths of a percent below average rates. Public body treasurers and
their depositories may negotiate a higher rate according to money market rates
and conditions.
Inquiries may be sent to Michael L. Fitzgerald, Treasurer of
State, State Capitol, Des Moines, Iowa 50319.
ARC 9630A
WORKFORCE DEVELOPMENT
DEPARTMENT[871]
Notice of Intended Action
Twenty–five interested persons, a
governmental subdivision, an agency or association of 25 or more persons may
demand an oral presentation hereon as provided in Iowa Code section
17A.4(1)“b.”
Notice is also
given to the public that the Administrative Rules Review Committee may, on its
own motion or on written request by any individual or group, review this
proposed action under section 17A.8(6) at a regular or special meeting where the
public or interested persons may be heard.
Pursuant to the authority of Iowa Code section 96.11, the
Director of the Workforce Development Department hereby gives Notice of Intended
Action to amend Chapter 23, “Employer’s Contribution and
Charges,” and adopt Chapter 41, “Request for Waiver of
Administrative Rule,” Iowa Administrative Code.
Subrule 23.40(2), paragraph “a,” is amended by
extending the contribution surcharge to the year 2001.
871-Chapter 41 is adopted in
compliance with IAPA and Executive Order Number 11.
Interested persons, governmental agencies and associations may
present written comments or statements on the proposed amendments not later than
4:30 p.m., February 15, 2000, to Reynel Dohse, Department of Workforce
Development, Unemployment Insurance Services Division, 1000 East Grand Avenue,
Des Moines, Iowa 50319.
A public hearing will be held at 9:30 a.m., February 15, 2000,
at the above address. The proposed amendments are subject to revision after the
Division considers all written and oral presentations. Persons who want to
convey their views orally should contact Reynel Dohse at (515)281–4986 or
at the above address.
These proposed rules are intended to implement Iowa Code
chapter 17A and Executive Order Number 11.
The following amendments are proposed.
ITEM 1. Amend subrule 23.40(2),
paragraph “a,” as follows:
a. For calendar years 1988 through 1998
2001, each employer except a governmental entity and a 501(c)(3)
nonprofit organization will have an administrative contribution surcharge added
to the contribution rate. The administrative contribution surcharge shall be a
percentage, rounded to the next highest one–hundredth of 1 percent of the
Federal Unemployment Tax Act (FUTA) taxable wage base in effect on the
computation date.
ITEM 2. Adopt the following
new chapter:
CHAPTER 41
REQUEST FOR WAIVER
OF ADMINISTRATIVE
RULE
871—41.1(17A,ExecOrd11) Requests for waiver of
rules. Any person may file a request for waiver of an administrative rule
of the Workforce Development Department[871], Iowa Administrative Code, by
writing a proper request which is received by the Division Administrator,
Division of Unemployment Insurance Services, 1000 East Grand Ave, Des Moines,
Iowa 50319. All requests for waiver of an administrative rule must be in
writing and meet all requirements set out in this chapter. A request is deemed
filed when it is received by the division administrator. The agency shall
provide the requester with a file–stamped copy of the request if the
requester provides the agency an extra copy for this purpose. The request must
be typewritten or legibly handwritten in ink and must substantially conform to
the following form:
IOWA WORKFORCE DEVELOPMENT
|
(Name of person requesting waiver).
|
}
|
Request for waiver of (Specify rule for which waiver is
requested).
|
The petition must provide the following information:
1. The name and address of the person or entity for whom a
waiver is requested.
2. A description and citation of the specific rule for which a
waiver is requested.
3. The specific waiver requested, including the precise scope
and operative period that the waiver will extend.
4. Relevant facts that the requester believes would justify a
waiver. This statement shall include a signed statement from the petitioner
attesting to the accuracy of the facts provided in the petition, and a statement
of reasons the petitioner believes will justify a waiver.
5. A history of the agency’s action relative to the
requester.
6. Any information regarding the agency’s treatment of
similar cases, if known.
7. The name, address and telephone number of any person inside
or outside state government who would be adversely affected by the grant of the
request, or who otherwise possesses knowledge of the matter with respect to the
waiver request.
8. Signed release of information authorizing persons with
knowledge regarding requests to furnish the agency with information pertaining
to the waiver, if necessary.
871—41.2(17A,ExecOrd11) Procedural
requirements.
41.2(1) The department shall acknowledge a request
upon receipt. Within 30 days after receipt of a request for waiver of an
administrative rule, the agency shall ensure that the requester has provided a
copy of the request to all persons who are required to receive one by provision
of law. The agency may also require the requester to give notice to send a copy
of the request to other persons who would have an interest in the subject
matter.
41.2(2) The agency shall grant or deny a request for
waiver of all or a portion of a rule as soon as practical, but in any event,
shall do so within 120 days of its receipt, unless requester agrees to a later
date. However, if a waiver request has been filed in a contested case
proceeding, the agency shall grant or deny the request no later than the time at
which the final decision in that contested case is issued. Failure of the
agency to grant or deny such a request within the required time period shall be
deemed a denial of that request by the agency. If the request for waiver
relates to a time requirement of an administrative rule, the request must be
received before the time specified in the rule has expired. Within seven days
of its issuance, any response issued under this rule shall be transmitted,
normally by depositing it in the mail, to the requester or the person to whom
the response pertains and to any other person entitled to such notice by any
provision of law.
871—41.3(17A,ExecOrd11) Criteria for
waiver.
41.3(1) The director of the workforce development
department shall make a decision as to whether circumstances justify the
granting of a waiver. Waivers are granted at the discretion of the director
after consideration of relevant facts. The requester shall assume the burden of
persuasion with regard to a request for waiver of an administrative rule. The
person requesting the waiver of the rule must provide clear and convincing
evidence that compliance with the rule will create an undue hardship on the
person for whom the waiver is requested; and the waiver of the rule on the basis
of the particular circumstances relevant to that specified person would be
consistent with public interest; and the waiver of the rule in the specific case
would not prejudice the substantial legal rights of any person.
41.3(2) The agency shall deny a request for waiver of
an administrative rule if the request waives any statute in whole or part. The
agency shall deny any request if it does not comply with the provisions of this
rule. The agency may grant waiver of a rule if it finds that application of all
or a portion of the rule to the circumstances of the specified person would not,
to any extent, advance or serve any purposes of the rule. The agency will deny
a request unless there are exceptional circumstances justifying an exception to
the general application of the rule in otherwise similar circumstances. A
waiver shall be denied if the material facts presented in the request are not
true or material facts have been withheld. The agency may request additional
information from the requesting party relative to the application and
surrounding circumstances.
871—41.4(17A,ExecOrd11) Public inspection. All
waiver requests and responses shall be indexed by administrative rule number and
available to members of the public for inspection at the administrative office
of the Workforce Development Department, 1000 East Grand Avenue, Des Moines,
Iowa. Identifying information concerning individuals as unemployment benefit
claimants and taxpayers and other identifying information may be withheld by the
agency in order to protect the confidentiality of parties as required by Iowa
Code chapter 96.
These rules are intended to implement Iowa Code chapter 17A
and Executive Order Number 11.
FILED EMERGENCY
ARC 9633A
EMERGENCY MANAGEMENT
DIVISION[605]
Adopted and Filed Emergency
Pursuant to the authority of Iowa Code sections 17A.3 and
34A.7A, the Emergency Management Division hereby amends Chapter 10,
“Enhanced 911 Telephone Systems,” Iowa Administrative
Code.
The amendments reflect the formal adoption of the Wireless
Enhanced 911 Implementation and Operation Plan, which is required by Iowa Code
section 34A.7A and rule 605—10.7(34A).
In compliance with Iowa Code section 17A.4(2), the Emergency
Management Division finds that notice and public participation are impracticable
because of the immediate need to begin the implementation and operation of an
enhanced wireless 911 phone system.
The Division also finds, pursuant to Iowa Code section
17A.5(2)“b”(2), that the normal effective date of these amendments
should be waived and these amendments should be made effective on February 1,
2000, as they confer a benefit upon the citizens of Iowa, joint E911 service
boards, the Iowa Department of Public Safety, and E911 service
providers.
These amendments are also published herein under Notice of
Intended Action as ARC 9632A to allow for public comment.
These amendments are intended to implement Iowa Code chapter
34A.
These amendments will become effective February 1,
2000.
The following amendments are adopted.
Amend rule 605-10.7(34A) to read as
follows:
605-10.7(34A)
Enhanced wireless 911 service plan. Each joint E911 service board, the
department of public safety, the E911 communications council, and wireless
service providers shall cooperate with the E911 program manager in preparing an
enhanced wireless 911 service plan for statewide implementation of enhanced
wireless 911 phase I and phase II implementation.
10.7(1) Plan specifications. The
enhanced wireless 911 service plan shall include, at a minimum, the following
information:
1. Maps showing geographic area to be served by each PSAP
receiving enhanced wireless 911 telephone calls.
2. A list of all public and private safety agencies within the
enhanced wireless 911 service area.
3. The geographic location of each PSAP receiving enhanced
wireless 911 calls and the name of the person responsible for the management of
the PSAP.
4. A set of guidelines for determining eligible cost for
wireless service providers, wire–line service providers, and public safety
answering points.
5. A statement of estimated charges for the implementation and
operation of enhanced wireless 911 phase I and phase II service, detailing the
equipment operated or needed to operate enhanced wireless 911 service, including
any technology upgrades necessary to provide service. Charges must be directly
attributable to the implementation and operation of enhanced wireless 911
service. Charges shall be detailed showing item(s) or unit(s) of cost, or both,
and include estimated charges from:
• Wireless
service providers.
• Wire–line
service providers for implementation and operation of enhanced wireless 911
service.
• Public
safety answering points.
6. A schedule for the implementation of enhanced wireless 911
phase I and phase II service.
10.7(2) Adoption by reference. The
“Wireless Enhanced 911 Implementation and Operation Plan,” effective
February 1, 2000, and available from the Emergency Management Division, Hoover
State Office Building, Des Moines, Iowa, or at the Law Library in the Capitol
Building, Des Moines, Iowa, is hereby adopted by reference.
[Filed Emergency 1/7/00, effective 2/1/00]
[Published 1/26/00]
EDITOR’S NOTE:
For replacement pages for IAC, see IAC Supplement 1/26/00.
ARC 9619A
LABOR SERVICES
DIVISION[875]
Adopted and Filed Emergency After Notice
Pursuant to the authority of Iowa Code sections 88.5 and
17A.3(1), the Labor Commissioner amends Chapter 10, “General Industry
Safety and Health Rules,” Iowa Administrative Code.
The amendment relates to methylene chloride, CFR correction;
dipping and coating operations; and powered industrial truck operator training,
correction.
Notice of Intended Action was published in the Iowa
Administrative Bulletin on August 25, 1999, as ARC 9288A.
In compliance with Iowa Code section 88.5(1)“b,” a
public hearing was scheduled for September 22, 1999. No comments were
received.
This amendment is identical to the Notice of Intended
Action.
Pursuant to Iowa Code section 17A.5(2)“b”(2) and
(3), this amendment shall become effective upon publication on January 26, 2000.
The Commissioner finds that this amendment confers a benefit on employees by
permitting them to be provided with safety and health equal those found in
states under federal OSHA’s jurisdiction and is necessary because of the
safety and health of employees in this state.
This amendment is intended to implement Iowa Code section
88.5.
The amendment will become effective January 26,
2000.
The following amendment is adopted.
Amend rule 875—10.20(88) by inserting at the end
thereof:
64 Fed. Reg. 13700 (March 22, 1999)
64 Fed. Reg. 13908 (March 23, 1999)
64 Fed. Reg. 22552 (April 27, 1999)
[Filed Emergency After Notice 1/5/00, effective
1/26/00]
[Published 1/26/00]
EDITOR’S NOTE:
For replacement pages for IAC, see IAC Supplement 1/26/00.
ARC 9620A
LABOR SERVICES
DIVISION[875]
Adopted and Filed Emergency After Notice
Pursuant to the authority of Iowa Code sections 88.5 and
17A.3(1), the Labor Commissioner amends Chapter 26, “Construction Safety
and Health Rules,” Iowa Administrative Code.
The amendment relates to a correction to the powered
industrial truck operator training rules previously adopted.
Notice of Intended Action was published in the Iowa
Administrative Bulletin on August 25, 1999, as ARC 9290A.
In compliance with Iowa Code section 88.5(1)“b,” a
public hearing was scheduled for September 22, 1999. No comments were
received.
This amendment is identical to the Notice of Intended
Action.
Pursuant to Iowa Code section 17A.5(2)“b”(2) and
(3), this amendment shall become effective upon publication on January 26, 2000.
The Commissioner finds that this amendment confers a benefit on employees by
permitting them to be provided with safety and health equal those found in
states under federal OSHA’s jurisdiction and is necessary because of the
safety and health of employees in this state.
This amendment is intended to implement Iowa Code section
88.5.
The amendment will become effective January 26,
2000.
The following amendment is adopted.
Amend rule 875—26.1(88) by inserting at the end
thereof:
64 Fed. Reg. 22552 (April 27, 1999)
[Filed Emergency After Notice 1/5/00, effective
1/26/00]
[Published 1/26/00]
EDITOR’S NOTE:
For replacement pages for IAC, see IAC Supplement 1/26/00.
ARC 9628A
NATURAL RESOURCE
COMMISSION[571]
Adopted and Filed Emergency
Pursuant to the authority of Iowa Code subsection 455A.5(6),
the Natural Resource Commission hereby gives Notice of Intended Action to amend
Chapter 51, “Game Management Areas,” Iowa Administrative
Code.
This amendment establishes uniform regulations for shooting
ranges located on game management areas. The language in this amendment was
initially approved by the Natural Resource Commission in a rule making which
became effective January 5, 2000, but was inadvertently omitted from the
amendment as it was filed.
In compliance with Iowa Code section 17A.4(2), the Department
finds that notice and public participation are impracticable because recent rule
making on this same topic was noncontroversial and there was no public
participation. The amendment adds language which does not create a hardship for
the general public or significantly alter the intent of the rule.
The Department also finds, pursuant to Iowa Code section
17A.5(2)“b”(2), that the normal effective date of the amendment
should be waived and this amendment should be made effective upon filing with
the Administrative Rules Coordinator, as it was initially approved in correct
form by the Natural Resource Commission in the rule making which became
effective January 5, 2000.
This amendment is intended to implement Iowa Code section
481A.6.
This amendment became effective January 7, 2000.
The following amendment is adopted.
Amend subrule 51.3(1) as follows:
51.3(1) Restrictions. The use or possession of
firearms on certain game management areas is restricted.
a. Target shooting, for the purposes of this rule, is defined
as the discharge of a firearm for any reason other than the taking of, or
attempting to take, any game birds, game animals, or furbearers. Target
shooting with shotguns shooting shot is not restricted to a specific range,
except as otherwise provided. Target shooters using shotguns with lead shot
cannot discharge the shot over water.
b. to f. No change.
g. No alcoholic beverages are allowed on the shooting range or
adjacent parking area.
h. and i. No change.
j. All requirements listed in this rule
subrule shall apply to the following shooting ranges:
(1) Badger Creek Area – Madison County.
(2) Banner Mine Area – Warren County.
(3) Bays Branch Area – Guthrie County.
(4) Hawkeye Wildlife Area – Johnson County.
(5) Hull Wildlife Area – Mahaska County.
(6) Mines of Spain – Dubuque County.
(7) Ocheyedan Wildlife Area – Clay County.
(8) Princeton Wildlife Area – Scott County.
(9) Spring Run Wildlife Area – Dickinson
County.
k. In addition to the requirements listed, the following
shooting ranges have range has specific
restrictions.
(1) Lake Darling Recreation Area – Washington
County. Hunting, trapping and the use of weapons of any kind, except for the
use of bow and arrow to take rough fish and except as provided in
571—subrule 61.6(3) and 571—Chapter 105, are
prohibited.
(2) McIntosh Wildlife Area – Cerro Gordo County.
The use or possession of firearms, except shotguns shooting shot only, is
prohibited.
(3) Oyens Shooting Range – Plymouth
County. The range is closed to the public except between 9 a.m. and sunset.
Law enforcement firearms training and qualification of local, county, state or
federal officers shall have priority over general public use of the range.
Shotguns shooting birdshot may be fired outside the firing tubes, but within the
designated range area. General shooting by the public shall take place on a
first–come, first–served basis.
l. McIntosh Wildlife Area – Cerro Gordo County. The
use or possession of firearms, except shotguns shooting shot only, is
prohibited.
[Filed Emergency 1/7/00, effective 1/7/00]
[Published 1/26/00]
EDITOR’S NOTE:
For replacement pages for IAC, see IAC Supplement 1/26/00.
FILED
ARC 9634A
EXECUTIVE COUNCIL[361]
Adopted and Filed
Pursuant to the authority of Iowa Code chapter 668A, the
Executive Council hereby adopts Chapter 12, “Disbursement of Money from
Civil Reparations Trust Fund,” Iowa Administrative Code.
These are new rules for the disbursement of money from the
Civil Reparations Trust Fund. The rules create a procedure for notice to the
public of money in the fund and for applications from the public to the
Executive Council for disbursement of the money from the fund.
Notice of Intended Action was published in the October 20,
1999, Iowa Administrative Bulletin as ARC 9438A. Written comments were
due to the State Treasurer’s office by November 9, 1999. No written
comments were received.
Based on further consideration of the proposed rules, the
Executive Council added language to subrule 12.3(3) to allow the agency to waive
the deadline for submission of application for good cause and added language to
rule 12.9(668A) to allow the Executive Council in its discretion to disburse
money while a motion for reconsideration by an applicant is pending to the
extent that resolution of any pending motion could not affect the disbursement
of money to other applicants. The adopted rules have been changed to reflect
these additions.
These rules will become effective March 1, 2000.
These rules are intended to implement Iowa Code chapter 17A as
amended by 1998 Iowa Acts, chapter 1202, and Iowa Code chapters 7D and
668A.
The following new chapter is adopted.
CHAPTER 12
DISBURSEMENT OF MONEY FROM
CIVIL
REPARATIONS TRUST FUND
361—12.1(668A) Eligibility. Money in the civil
reparations trust fund may be disbursed upon application for indigent civil
litigation programs or insurance assistance programs.
361—12.2(668A) Notice of funds. The executive
council shall provide notice of availability of money in the fund in the
following ways:
12.2(1) Iowa Administrative Bulletin. The executive
council shall publish notice of the balance in the fund in the Iowa
Administrative Bulletin semiannually in January and July of each year and within
30 days of the deposit of any amount into the fund exceeding $10,000. If the
deposit of an amount exceeding $10,000 would cause notice within 30 days of the
deposit to be published in January or July, no additional publication is
required.
12.2(2) First–class mail. The executive council
shall maintain a mailing list of those persons who wish to receive notice of the
balance in the fund. Notice shall be sent semi–annually in January and
July of each year and within 30 days of the deposit of any amount into the fund
exceeding $10,000 by first–class mail to all persons on the mailing list.
If the deposit of an amount exceeding $10,000 would cause notice within 30 days
of the deposit to be mailed in January or July, no additional mailing is
required. Any person may be added to the mailing list on request.
In the event that there is no money in the fund in January or
July, no notice will be published or mailed.
361—12.3(668A) Applications. The executive
council shall accept applications for money from the fund for a period of 30
days after notice has been published in the Iowa Administrative Bulletin or sent
by first–class mail. Applications will be not be accepted in advance of
this time period.
12.3(1) Forms. Application forms are available in the
office of the state treasurer.
12.3(2) Filing. Applications shall be filed with the
office of the state treasurer.
12.3(3) Timeliness. An application is timely if it is
postmarked on the thirtieth day after the date of publication in the Iowa
Administrative Bulletin or on the thirtieth day after the date affixed to the
notice sent by first–class mail, whichever is later. The executive
council may accept applications submitted after this deadline only for good
cause upon motion in writing.
361—12.4(668A) Criteria. In determining whether
to grant an application for money from the fund, the executive council shall
consider the following factors:
1. The purpose for which the money will be utilized;
2. The number of people who will be served by the
money;
3. The availability to the applicant of alternative sources of
money;
4. The degree to which the applicant complied with legal
restrictions on the use of the money under any prior applications.
361—12.5(668A) Disposition of applications. The
executive council shall determine the disposition of all pending applications
and notify all applicants of the decision by first–class mail. Notice of
disposition shall be sent to all applicants on the same date.
361—12.6(668A) Motion for reconsideration. Any
applicant who is aggrieved or adversely affected by the disposition of the
applicant’s application must file a motion for reconsideration in the
office of the state treasurer within 15 days of the date affixed to the notice
of disposition. The motion is deemed filed when received and date–stamped
by the treasurer.
361—12.7(668A) Grounds. The motion for
reconsideration must delineate the specific grounds for reconsideration. An
applicant may request a contested case hearing; however, any request for a
contested case hearing must specifically delineate the facts in dispute to be
contested and determined at the hearing.
361—12.8(668A) Procedure. The executive council
shall rule on any pending motion for reconsideration, including a request for a
contested case hearing. In the event that a request for a contested case
hearing is granted, the proceeding shall be conducted as provided in 361 IAC
10.8(17A,68B) et seq. The burden of proof by a preponderance of the evidence
shall be on the requester to establish grounds for reconsideration. The
decision of the executive council shall be defended by the office of the
attorney general.
361—12.9(668A) Disbursement of money. No money
will be disbursed from the fund after disposition of all applications until the
time period for filing a motion for reconsideration has expired. After the time
period for filing a motion for reconsideration has expired but while a motion
for reconsideration by any applicant is pending, the executive council in its
discretion may disburse money from the fund to applicants who have not filed a
motion for reconsideration. Money may be disbursed to applicants while a motion
for reconsideration is pending only to the extent that resolution of any pending
motion could not affect the disbursement of money to other applicants.
361—12.10(668A) Administrative costs. The costs
of administering this fund, including any costs associated with the conduct of
any contested case proceeding challenging the disbursement of money from the
fund and costs for postage and copying, shall be billed to the fund after
approval by the executive council.
These rules are intended to implement Iowa Code chapter 17A as
amended by 1998 Iowa Acts, chapter 1202, and Iowa Code chapters 7D and
668A.
[Filed 1/10/00, effective 3/1/00]
[Published 1/26/00]
EDITOR’S NOTE:
For replacement pages for IAC, see IAC Supplement 1/26/00.
ARC 9616A
INSURANCE DIVISION[191]
Adopted and Filed
Pursuant to the authority of Iowa Code section 502.607, the
Insurance Division hereby amends Chapter 50, “Regulation of Securities
Offerings and Those Who Engage in the Securities Business,” Iowa
Administrative Code.
These rules impose certain advertising, examination, and
disclosure requirements upon issuers and agents who wish to sell viatical
settlement contracts within the state of Iowa. A waiver provision is also
included herein which applies specifically to these rules.
Notice of Intended Action was published in the August 11,
1999, Iowa Administrative Bulletin as ARC 9273A. Comments were received
at a public hearing held on Wednesday, September 8, 1999. Five comments were
received after the hearing. The administrator revised the proposed rules in
light of those comments. The time period for submission of proposed
advertising has been clarified as ten business days. The administrator may deem
advertisements false and misleading.
These rules will become effective on March 1, 2000.
These rules are intended to implement Iowa Code section
502.201 and Iowa Code Supplement sections 502.102 and 502.202.
The following new rules are adopted.
VIATICAL SETTLEMENT CONTRACTS
191—50.120(502) Advertising of viatical settlement
contracts.
50.120(1) Under this rule, the term
“advertisement” includes any written, electronic or printed
communication or any communication by means of recorded telephone messages or
transmitted on radio, television, the Internet, or similar communications media,
including film strips, motion pictures, and videos, published in connection with
the offer or sale of a viatical settlement contract.
50.120(2) The issuer and agent shall file all viatical
settlement contract advertisements with the administrator not less than ten
business days prior to the date of use or a shorter period as the administrator
may permit. The administrator shall mark the advertisements with allowance for
use or expressly disapprove them during this time frame. The advertisements
shall not be used in Iowa until a copy thereof, marked with allowance for use,
has been received from the administrator.
50.120(3) Viatical settlement contract advertisements
should contain no more than the following:
a. The name of the issuer;
b. The address and telephone number of the issuer;
c. A brief description of the security, including minimum
purchase requirements and liquidity aspects;
d. If rate of return is advertised, it must be stated as the
annual average rate of return, with a disclaimer that this is an annual average
rate of return, that individual investor rates of return will vary based upon
the viator’s projected and actual date of death, and that an annual rate
of return on a viatical settlement contract cannot be
guaranteed;
e. The name, address and telephone number of the agent of the
issuer authorized to sell the viatical settlement contracts;
f. A statement that the advertisement is neither an offer to
sell nor a solicitation of an offer to purchase and that any offer or
solicitation may only be made by providing a disclosure document; and
g. How a copy of the disclosure document may be
obtained.
50.120(4) Notwithstanding the provisions of rule
191— 50.25(502), certain viatical settlement advertisements may be deemed
false and misleading on their face by the administrator and are prohibited under
Iowa Code sections 502.401 and 502.602. False and misleading viatical
settlement advertisements include, but are not limited to, the following
representations:
a. “Fully secured,” “100% secured,”
“fully insured,” “secure,” “safe,”
“backed by rated insurance company(ies),” “backed by federal
law,” “backed by state law,” or similar
representations;
b. “No risk,” “minimal risk,”
“low risk,” “no speculation,” “no
fluctuation,” or similar representations;
c. “Qualified or approved for IRA, Roth IRA, 401K, SEP,
403B, Keogh plans, TSA, other retirement account rollovers,” “tax
deferred,” or similar representations;
d. “Guaranteed fixed return,” “guaranteed
annual return,” “guaranteed principal,” “guaranteed
earnings,” “guaranteed profits,” “guaranteed
investment,” or similar representations;
e. “No sales charges or fees,” or similar
representations;
f. “High yield,” “superior return,”
“excellent return,” “high return,” “quick
profit,” or similar representations;
g. “Perfect investment,” “proven
investment,” or similar representations;
h. Purported favorable representations or testimonials about
the benefits of viaticals as an investment, taken out of context from
newspapers, trade papers, journals, radio and television programs, and all other
forms of print and electronic media.
This rule is intended to implement Iowa Code section 502.201
and Iowa Code Supplement sections 502.102 and 502.202.
191—50.121(502) Application by viatical settlement
contract issuers and registration of agents to sell viatical settlement
contracts.
50.121(1) Under this rule, the term “viatical
settlement contract issuer” includes, but is not limited to, any
individual, company, corporation or other entity that offers or sells,
directly or indirectly, viatical settlement contracts to investors.
50.121(2) A viatical settlement contract issuer
employing agents in Iowa must make prior application to the administrator for
this authority. The application shall be made by letter and shall
include:
a. A statement of the issuer’s intent to employ agents
for the sale of its viatical settlement contracts; and
b. Name, address, social security number and proof of
satisfaction of subrule 50.121(3) for each agent.
50.121(3) An applicant for registration as an
Iowa–licensed agent of an issuer of viatical settlement contracts shall
file with the administrator:
a. Proof of obtaining a passing grade on the NASD Series 7
examination;
b. Proof of obtaining a passing grade on the NASD Series 63
examination;
c. An accurate, complete and signed Form U–4;
and
d. A $30 filing fee.
This rule is intended to implement Iowa Code section 502.201
and Iowa Code Supplement sections 502.102 and 502.202.
191—50.122(502) Risk disclosure. Viatical
settlement contract issuers and registered agents of issuers must provide
specific, written disclosures of risk to Iowa investors at the time of the
initial offer to sell a viatical settlement contract. These disclosures must be
preceded by the following caption, which must be in bold, 16–point
typeface:
IMPORTANT RISK DISCLOSURE
INFORMATION—READ BEFORE SIGNING ANY VIATICAL SETTLEMENT
CONTRACT
Certain items must be disclosed including, but not limited to,
the following:
1. That the actual annual rate of return on any viatical
settlement contract is dependent upon (a) an accurate projection of the
viator’s life expectancy, and (b) the actual date of the viator’s
death. An annual “guaranteed” rate of return is not
possible;
2. Whether, after purchasing the viatical settlement contract,
the investor will be responsible for payment of premiums on the contract if the
viator lives longer than projected. If the investor will be responsible for
such premiums, the amount of the premium payment and its negative effect on the
investor’s return must be disclosed to the investor;
3. Whether any premium payments on the contract have been
escrowed. The investor must be provided the date upon which the escrowed funds
will be depleted, informed whether the investor will be responsible for payment
of premiums thereafter, and informed of the amount of such premiums;
4. Whether any premium payments on the contract have been
waived. The investor must be informed whether the investor will be responsible
for payment of the premiums if the insurer who wrote the policy terminates the
waiver after purchase, and informed of the amount of such premiums;
5. Whether the investor is responsible for payment of premiums
on the contract if the viator returns to health, and the amount of such
premiums;
6. Whether the investor is entitled to all or part of the
investor’s investment under the contract if the viator’s underlying
policy is later determined to be null and void;
7. Whether the insurance policy is a group policy and, if so,
the special risks associated with group policies including, but not limited to,
whether the investor is responsible for payment of additional premiums if the
policies are sold or converted;
8. Whether the insurance policy is term insurance and, if so,
the special risks associated with term insurance including, but not limited to,
whether the investor is responsible for additional premium costs if the viator
continues the term policy at the end of the current term;
9. Whether the investor will be the beneficiary or owner of
the insurance policy and, if the investor is the beneficiary, the special risks
associated with beneficiary status;
10. Whether the insurance policy is contestable and, if so,
the special risks associated with contestability including, but not limited to,
the risk that the investor will have no claim or only a partial claim to death
benefits should the insurer cancel the policy within the contestability
period;
11. Who is making the projection of the viator’s life
expectancy, the information this projection is based upon, and the relationship
of the projection maker to the issuer;
12. Who is monitoring the viator’s condition, how often
the monitoring is done, how the date of death is determined, and how and when
this information will be transmitted to the investor;
13. Whether the insurer who wrote the viator’s
underlying policy has any additional rights which could negatively affect or
extinguish the investor’s rights under the viatical settlement contract,
what these rights are, and under what conditions these rights are
activated;
14. That a viatical settlement contract is not a liquid
investment and that there is no established secondary market for resale of these
products by the investor;
15. That the investor will receive no returns (i.e., dividends
and interest) until the viator dies; and
16. That the investor may lose all benefits or receive
substantially reduced benefits if the insurer goes out of business during the
term of the viatical investment.
This rule is intended to implement Iowa Code section 502.201
and Iowa Code Supplement sections 502.102 and 502.202.
191—50.123(502) Duty to disclose. Issuers and
agents equally share an affirmative duty to disclose all relevant and material
information to prospective investors in viatical settlement contracts. The
required disclosure is the registration statement required by Iowa Code section
502.207 which has been reviewed and made effective by the
administrator.
This rule is intended to implement Iowa Code section 502.201
and Iowa Code Supplement sections 502.102 and 502.202.
191—50.124(502) Waivers. The administrator may
grant a waiver of a rule pertaining to issuer and agent applications for
viatical licensure.
50.124(1) No waiver shall be granted from a
requirement imposed by statute. Any waiver must be consistent with statutory
requirements.
50.124(2) A waiver under this subrule may be granted
only upon a showing of all the following:
a. Because of special circumstances, applying the rule would
impose an undue burden or extreme hardship on the requester;
b. Granting the waiver would not adversely affect the public
interest and the protection of investors; and
c. Granting the waiver would provide substantially equal
protection of public health and safety as would compliance with the
rule.
50.124(3) A request for waiver shall be made at any
time within 60 days of the initial application and shall include the following
information:
a. The name, address, and telephone number of the person
requesting the waiver;
b. The specific rule from which a waiver is
requested;
c. The nature of the waiver requested;
d. An explanation of all facts relevant to the waiver request,
including all material facts necessary for the administrator to evaluate the
criteria for granting a waiver as defined in subrule 50.124(2); and
e. A description of any prior communication between the
administrator and the requester regarding the proposed waiver.
50.124(4) The administrator shall rule upon all waiver
requests and transmit the ruling to the requester. The ruling shall include the
reason for granting or denying the request. The administrator’s ruling
shall constitute final agency action for the purposes of Iowa Code chapter
17A.
50.124(5) The administrator may impose reasonable
conditions when granting a waiver to achieve the objectives of the particular
rule being waived.
50.124(6) If at any time the administrator finds the
facts as stated in the waiver request are not true, that material facts have
been withheld, or that the requester has failed to comply with conditions set
forth in the waiver, the administrator may cancel the waiver and seek additional
sanctions against the issuer and agent as provided by this chapter and Iowa Code
chapter 502.
50.124(7) Any request for an appeal from a decision
granting, denying, or canceling a waiver shall comply with the procedures
provided in Iowa Code chapter 17A. An appeal shall be made within 30 days after
the administrator’s ruling in response to the waiver request.
50.124(8) All final rulings in response to waiver
requests shall be indexed and available to members of the public at the
administrator’s office.
This rule is intended to implement Iowa Code section 502.201
and Iowa Code Supplement sections 502.102 and 502.202.
[Filed 1/5/00, effective 3/1/00]
[Published 1/26/00]
EDITOR’S NOTE:
For replacement pages for IAC, see IAC Supplement 1/26/00.
ARC 9624A
LOTTERY DIVISION[705]
Adopted and Filed
Pursuant to the authority of Iowa Code section 99E.9, the Iowa
Lottery Board, for the Lottery Division of the Department of Revenue and
Finance, amends Chapter 2, “Licensing,” Iowa Administrative
Code.
This amendment makes subrule 2.12(1) more readable by breaking
a lengthy list of items in a single paragraph into a series of lettered
paragraphs, and it adds a new provision clarifying and implementing a stepped
penalty process governing penalties for failure to comply with the provisions of
Iowa Code section 99E.18(2) regarding sales of lottery tickets to persons under
21 years of age.
Notice of Intended Action was published in the Iowa
Administrative Bulletin on October 6, 1999, as ARC 9377A. The Lottery
solicited comment by submitting copies of the amended rule, in the form noticed
and ultimately adopted, to law enforcement agencies and associations, retailer
associations and an anti–lottery spokesperson. No comment was received
from any source, and no hearing was scheduled.
This amendment is identical to that published under Notice of
Intended Action.
The Iowa Lottery Board adopted this amendment on December 30,
1999.
This amendment will become effective on March 1,
2000.
This amendment is intended to implement Iowa Code chapter
99E.
EDITOR’S NOTE:
Pursuant to recommendation of the Administrative Rules Review Committee
published in the Iowa Administrative Bulletin, September 10, 1986, the text of
this amendment [2.12] is being omitted. This amendment is identical to that
published under Notice as ARC 9377A, IAB 10/6/99.
[Filed 1/6/00, effective 3/1/00]
[Published
1/26/00]
[For replacement pages for IAC, see IAC Supplement
1/26/00.]
ARC 9635A
REVENUE AND FINANCE
DEPARTMENT[701]
Adopted and Filed
Pursuant to the authority of Iowa Code section 421.14, the
Department of Revenue and Finance hereby adopts amendments to Chapter 71,
“Assessment Practices and Equalization,” Chapter 73, “Property
Tax Credit and Rent Reimbursement,” Chapter 74, “Mobile, Modular and
Manufactured Home Tax,” Chapter 75, “Property Tax
Administration,” Chapter 77, “Determination of Value of Utility
Companies,” Chapter 78, “Property Tax Exemptions,” Chapter 79,
“Real Estate Transfer Tax,” and Chapter 80, “Property Tax
Credits and Exemptions,” Iowa Administrative Code.
Notice of Intended Action was published in IAB Volume XXII,
Number 11, page 872, on December 1, 1999, as ARC 9500A.
The rule changes incorporate the provisions of 1999 Iowa Acts,
Senate Files 53, 136, 392, 462, and 473 and House Files 417, 755, 757, 758, and
769.
These amendments are identical to those published under Notice
of Intended Action.
These amendments will become effective March 1, 2000, after
filing with the Administrative Rules Coordinator and publication in the Iowa
Administrative Bulletin.
These amendments are intended to implement Iowa Code chapters
425, 426A, 427, 428A, 433, 435, 440, 443, 445, 446, 476, and 499B.
EDITOR’S NOTE:
Pursuant to recommendation of the Administrative Rules Review Committee
published in the Iowa Administrative Bulletin, September 10, 1986, the text of
these amendments [71.1, 71.25, 73.1, 73.10, 73.14, 73.27(3), 73.29, 74.4, 75.6,
75.7, 77.1, 78.1, 78.4, 79.1, 79.5, 80.2, 80.4, 80.14] is being omitted. These
amendments are identical to those published under Notice as ARC 9500A,
IAB 12/1/99.
[Filed 1/7/00, effective 3/1/00]
[Published
1/26/00]
[For replacement pages for IAC, see IAC Supplement
1/26/00.]
ARC 9636A
REVENUE AND FINANCE
DEPARTMENT[701]
Adopted and Filed
Pursuant to the authority of Iowa Code section 421.17, the
Department of Revenue and Finance hereby amends Chapter 107, “Local Option
Sales and Service Tax,” and Chapter 108, “Local Option School
Infrastructure Sales and Service Tax,” Iowa Administrative Code.
Notice of Intended Action was published in IAB Volume XXII,
Number 11, page 877, on December 1, 1999, as ARC 9499A.
Item 1 adopts new rule 701—107.2(422B) and Item 11
amends 701—108.5(422E) to provide that the sales of natural gas,
electricity and electrical services that are subject to Iowa use tax are also
subject to local option taxes. The new rule 701—107.2(422B) in Item 1
also restructures the rule and includes new repeal dates and the notice
requirements by the county auditor to the director. Item 2 amends rule
701—107.8(422B) by restructuring the rule and adding a new subrule to
include new nexus requirements for imposition of all local option taxes. Item 3
amends rule 701—107.9(422B) by providing that the sales of natural gas,
electricity, and electrical services that are subject to Iowa use tax are also
subject to local option taxes. This amendment also provides that the sales of
certain equipment to contractors are exempt from local option tax. Items 4 and
13 amend rules 701—107.10(422B) and 701—108.7(422E) by providing the
new date by which an adjustment for local option overpayment must be made. The
amendment of 701— 107.10(422B) in Item 4 also provides that a certified
census may be used in the distribution formula for local option tax. Item 5
amends rule 701—107.14(422B) by setting forth the new requirements of city
residency for a county to qualify for imposing local option tax. Items 14 and
15 amend 701— Chapter 108 by adopting new rules 701—108.8(422E) and
701—108.9(422E) which implement the law governing construction contractor
refunds and the authority granted under Iowa Code chapter 128E agreements,
respectively. Item 8 amends subrules 108.2(3), 108.2(5), and 108.2(6) for the
implementation of repeal dates and notice by county auditor requirements and
sets forth that sales of natural gas, electricity and electrical services that
are subject to Iowa use tax are also subject to local option taxes.
These amendments are identical to those published under Notice
of Intended Action.
These amendments will become effective March 1, 2000, after
filing with the Administrative Rules Coordinator and publication in the Iowa
Administrative Bulletin.
These amendments are intended to implement Iowa Code chapters
422B and 422E as amended by 1999 Iowa Acts, chapters 151 and 156 which relate to
local option taxes.
EDITOR’S NOTE:
Pursuant to recommendation of the Administrative Rules Review Committee
published in the Iowa Administrative Bulletin, September 10, 1986, the text of
these rules [amendments to Chs 107 and 108] is being omitted. These rules are
identical to those published under Notice as ARC 9499A, IAB
12/1/99.
[Filed 1/7/00, effective 3/1/00]
[Published
1/26/00]
[For replacement pages for IAC, see IAC Supplement
1/26/00.]
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