Small Business Impact
The rules are not expected to impose significant costs or other adverse impacts on small businesses because the rules address submittal of documentation, and other activities, only by applicants that choose to pursue tax credits for job creation, capital investment, employee training and corporate headquarters.
Initial regulatory flexibility analysis
Types of small businesses that will be affected by the rules.
Businesses and individuals that choose to pursue tax benefits for job creation, capital investment, employee training, and corporate headquarters, as established under sections
560.701
to
560.706
of the Statutes.
Reporting, bookkeeping and other procedures required for compliance with the rules.
A business certified under the rules must enter into a written agreement with the Department that establishes the responsibilities which the business will fulfill with regard to the Department's terms and conditions in allocating a tax credit.
Types of professional skills necessary for compliance with the rules.
No new professional skills are necessary for compliance with the rules.
Rules have a significant economic impact on small businesses?
No.
Small business regulatory coordinator
Any inquiries for the Small Business Regulatory Coordinator for the Department of Commerce can be directed to Sam Rockweiler, Department of Commerce, Division of Environmental and Regulatory Services, P.O. Box 14427, Madison, WI 53707, or at
sam.rockweiler@wi.gov
, or telephone (608) 266-0797.
Environmental Impact
The Department has considered the environmental impact of the proposed rules. In accordance with Chapter
Comm 1
, the proposed rules are a Type III action. A Type III action normally does not have the potential to cause significant environmental effects and normally does not involve unresolved conflicts in the use of available resources. The Department has reviewed these rules and finds no reason to believe that any unusual conditions exist. At this time, the Department has issued this notice to serve as a finding of no significant impact.
Fiscal Estimate
Assumptions used in arriving at fiscal estimate
Although the rules will newly result in review of documentation relating to certifying applicants as eligible to then claim allocated tax credits for job creation, capital investment, employee training, and corporate headquarters, the number of these reviews and allocations is expected to be about the same as in the five development-zone programs that are being replaced by this program. Therefore, the proposed rules are not expected to have any significant fiscal effect on the Department.
The proposed rules are not expected to impose any significant costs on the private sector because the rules address submittal of documentation, and other activities, only by applicants that choose to pursue tax credits for job creation, capital investment, employee training and corporate headquarters.
State fiscal effect
None.
Local government fiscal effect
None.
Long-range fiscal implications
None known.
Agency Contact Person
Todd Jensen, Wisconsin Department of Commerce, Bureau of Business Finance, 201 West Washington Avenue, Madison, WI, 53703; telephone: (608) 266-3074; E-Mail:
Todd.Jensen@commerce.state.wi.us
.
Notice of Hearing
Financial Institutions — Banking
NOTICE IS HEREBY GIVEN That pursuant to ss.
224.72 (7) (bm)
and
(8)
,
224.725 (4) (c)
,
(5) (b)
and
(8)
,
224.73 (3) (a)
, and
227.11 (2)
, Stats., the Department of Financial Institutions, Division of Banking will hold a public hearing to consider a rule to repeal and recreate Chapters
DFI-Bkg 40
,
41
,
42
and
43
; amend s.
DFI-Bkg 44.01 (1) (f)
; create s.
DFI-Bkg 44.01 (1) (g)
; repeal Chapter
DFI-Bkg 45
; and create Chapter
DFI-Bkg 47
, relating to the transition from a registration system to a license system under subch.
III of ch. 224
, Stats., branch offices, mortgage broker agreements, surety bonds and trade names.
Hearing Information
The public hearing will be held at:
September 14, 2009 at 1:00 pm.
Department of Financial Institutions
345 W. Washington Avenue
5
th
floor
Madison, Wisconsin
Copies of Proposed Rule, Submission of Written Comments and Contact Persons
To obtain a copy of the proposed rule or fiscal estimate at no charge, to submit written comments regarding the proposed rule, or for questions regarding the agency's internal processing of the proposed rule, contact Mark Schlei, Deputy General Counsel, Department of Financial Institutions, Office of the Secretary, P.O. Box 8861, Madison, WI 53708-8861, tel. (608) 267-1705, e-mail
mark.schlei@wisconsin.gov
. A copy of the proposed rule may also be obtained and reviewed at the Department of Financial Institution's website,
www.wdfi.org
. Written comments must be received by the conclusion of the department's hearing regarding the proposed rule.
For substantive questions on the rule, contact Michael J. Mach, Administrator, Department of Financial Institutions, Division of Banking, P.O. Box 7876, Madison, WI 53707-7876, tel. (608) 266-0451.
Analysis Prepared by the Department of Financial Institutions, Division of Banking
Statute(s) interpreted
Statutory authority
Related statute or rule
None.
Explanation of agency authority
Summary of proposed rule
The objective of the rule is to repeal and recreate chs.
DFI-Bkg 40
,
41
,
42
and
43
; amend s.
DFI-Bkg 44.01
; repeal ch.
DFI-Bkg 45
; and create ch.
DFI-Bkg 47
. The purpose of this rule is to bring these chapters into conformity with subch. III, ch.
224
, Stats., as mandated and affected by
2009 Wisconsin Act 2
and the Secure and Fair Enforcement for Mortgage Licensing ("S.A.F.E.") Act of 2008 regarding the transition from a registration system to a license system for mortgage bankers, mortgage brokers and mortgage loan originators. Primarily affected are provisions regarding terminology, and licensing requirements and procedures. Because of the numerous changes to terminology and deletion of text, the division proposes to repeal and recreate most of these chapters rather than extensively amend and renumber; otherwise the substance of the text remains largely the same. The purpose of the rule is also to provide clarification regarding branch offices, mortgage broker agreements, surety bonds and trade names.
Comparison with federal regulations
The requirements of
2009 Wisconsin Act 2
stem from the Secure and Fair Enforcement for Mortgage Licensing ("S.A.F.E.") Act of 2008.
Comparison with rules in adjacent states
Illinois, Iowa and Michigan have all adopted or are in the process of adopting the S.A.F.E Act of 2008; Minnesota is not adopting this act.
Summary of factual data and analytical methodologies
The changes are largely ones of terminology and procedure that stem directly from the S.A.F.E. Act of 2008 and
2009 Wisconsin Act 2
. The division applied its own experience in its regulation of mortgage bankers and mortgage brokers regarding the clarifications on branch offices, surety bonds and trade names.
Small Business Impact
The rule reflects changes imposed congressionally by the S.A.F.E. Act of 2008 and legislatively by
2009 Wisconsin Act 2
, and not by the department. Clarifications to matters regarding branch offices, mortgage loan agreements, surety bonds and trade names are already existing obligations for mortgage bankers and mortgage brokers. The rule itself therefore imposes no substantial impact on small businesses.
Fiscal Estimate
The state fiscal effect is an expected increase in costs which may be possible to absorb within the agency's budget; there are no local government costs.
Notice of Hearings
Health Services
Community Services, Chs. DHS 30—
NOTICE IS HEREBY GIVEN that pursuant to ss.
54.15 (7)
and
227.11 (2) (a)
, Stats., the Department of Health Services will hold public hearings to consider
the repeal and recreation of Chapter
DHS 85
, relating to non-profit corporations and unincorporated associations as guardians, and affecting small businesses.
Hearing Information
Date and Time
|
Location
|
October 8, 2009
1:00 PM to 3:00 PM
|
Waukesha State Office Bldg.
141 N. W. Barstow Street
Room 151
Waukesha
,
WI
|
October 14, 2009
11:00 AM to 1:00 PM
|
La Crosse Public Library
800 Main Street
Main Auditorium
La Crosse, WI
|
Accessibility
English
DHS is an equal opportunity employer and service provider. If you need accommodations because of a disability or need an interpreter or translator, or if you need this material in another language or in an alternate format, you may request assistance to participate by contacting Pat Benesh at (608) 264-9896. You must make your request at least 7 days before the activity.
Spanish
DHS es una agencia que ofrece igualdad en las oportunidades de empleo y servicios. Si necesita algún tipo de acomodaciones debido a incapacidad o si necesita un interprete, traductor o esta información en su propio idioma o en un formato alterno, usted puede pedir asistencia para participar en los programas comunicándose con Pat Benesh al número at (608) 264-9896. Debe someter su petición por lo menos 7 días de antes de la actividad.
Hmong
DHS yog ib tus tswv hauj lwm thiab yog ib qhov chaw pab cuam uas muab vaj huam sib luag rau sawv daws. Yog koj xav tau kev pab vim muaj mob xiam oob qhab los yog xav tau ib tus neeg pab txhais lus los yog txhais ntaub ntawv, los yog koj xav tau cov ntaub ntawv no ua lwm hom lus los yog lwm hom ntawv, koj yuav tau thov kev pab uas yog hu rau Pat Benesh ntawm at (608) 264-9896. Koj yuav tsum thov qhov kev pab yam tsawg kawg 7 hnub ua ntej qhov hauj lwm ntawd.
Agency Contact Person
Pat Benesh, Quality Assurance Program Spec-Senior
Division of Quality Assurance
1 West Wilson St., Room 1150
Madison, WI 53701
Phone: 608-264-9896
Fax: 608-267-7119
Submission of Written Comments
Comments may be submitted to the agency contact person that is listed above. The deadline for submitting comments is October 21, 2009.
Analysis Prepared by the Department of Health Services
Statute interpreted
Statutory authority
Explanation of agency authority
Section
54.15 (7)
, Stats., provides the Department with the authority to promulgate rules to specify standards for approval of non-profit corporate guardians or unincorporated associations as guardians of a person or an estate, or both.
Related statute or rule
Plain language analysis
Chapter
DHS 85
establishes standards for the approval of non-profit corporate guardians or unincorporated associations as guardians of a person or an estate.
In this order, the Department proposes to repeal and recreate ch.
DHS 85
as follows:
1. To update the rules to reflect current standards of practice of corporate guardianships in the areas of staff qualifications and training, caregiver background checks, duties and powers of the guardian, adequacy of staff, rights of wards, contacts with wards, wards records, and conflict of interest standards.
2. Require corporate guardians to maintain policies in the areas of abuse and neglect misappropriation of property, grievance procedure for use by wards and interested parties, and complaint and grievance investigation.
3. Reflect the increasing number of adults in need of guardianship and increase in their acuity level.
4. Incorporate provisions limiting the number of wards a corporate guardian may have.
5. Establish standards for approval, changing ownership and closing a corporate guardianship agency and to determine whether a person is fit and qualified to operate as a corporate guardian.
Comparison with federal regulations
There appear to be no existing or proposed federal regulations that address the activities to be regulated by the proposed rule.
Comparison with rules in adjacent states
Illinois
There are no administrative codes governing guardianship services in Illinois.
Iowa
In Iowa, counties provide guardianship services for individuals who do not have a suitable family member or interested person who will act as guardian. The rules governing guardianship are found in probate laws and include general provisions concerning the determination of incompetency of the proposed ward, the petition of appointment of guardian, the notice to the proposed ward and representation of the ward at the hearing. In addition, the rules provide for the notification of guardianship powers including providing for the care of the ward, managing the ward's personal property, assisting the ward in developing self-reliance and receiving professional care, counseling, treatment or services as needed and ensuring that the ward receives necessary emergency medical services. The rule also provides for the appointment of a conservator, temporary conservator, standby conservator and liability of conservators.
Iowa code, 633.551 to 633.701 contains rules governing the provision of guardianships and conservatorships.
Michigan
Michigan has established administrative rule governing the provision of public guardianship services for persons with mental retardation. The rule establishes standards for the determination of the need for guardianship, standards for informed consent and the admission procedures into a facility. The rule provides for emergency guardianship, the circumstances the provision may be applied and the powers of the emergency guardian. The rule also includes standards for a facility or program in guardianship proceeding, guardianship for minors and termination or modification of guardianship orders.
Administrative Code Section: Mich. Adm. Code R. 330.6006 to 330.6031 contains rules governing the provision of guardianship to persons who are designated mentally retarded.
Minnesota
Minnesota has established administrative rule governing the provision of public guardianship services for a person with mental retardation. The rule establishes standards related to the process used to appoint a public guardian, the limitations of the guardian's powers and duties and standards for consent determinations. The duties of the public guardian are outlined in rule and include determining the ward's place of residence consistent with the ward's best interests, making provisions for the ward's care, comfort, medical, social and recreational needs, taking reasonable care of the ward's property and approving or withholding approval of any contract the ward makes. Special duties of the guardian such as visiting the ward at least twice a year, taking action and making decisions encouraging the least restrictive effect on the ward's personal freedom and encouraging maximum self-reliance on the part of the ward are also included in the rule. The rule provides standards related to non-delegated consent, non-delegated consent requiring a court order and the process for modification or termination of public guardianship. No administrative rule could be found for guardians for persons who are not mentally retarded.
Administrative Code Section: Minn. R. 9525.3010 to 9525.3100.
Summary of factual data and analytical methodologies
The Department relied on all of the following sources to draft the proposed rule and to determine the impact on small businesses.
•
The Department formed an advisory committee consisting of representatives from the Disability Rights Wisconsin, Inc., the Wisconsin Guardianship Association, the Coalition of Wisconsin Aging Groups, the Board on Aging and Long Term Care, County Adult Protective Services staff including County Departments of Social Services, Human Services, Community Programs, County Registers in Probate and Department staff. The advisory committee reviewed the initial draft of the rule and provided comments. The rule was revised based upon the comments made by the advisory committee.
•
The Department held four listening sessions with wards in Eau Claire, Fort Atkinson, Green Bay and Milwaukee to gain their perspective on corporate guardianship services. The information obtained from wards was shared with the advisory committee for comment. The views of wards were given the same consideration as the views expressed by other members of the Advisory Committee when drafting rule language. For example, comments from wards related to frequency and location of visits with their guardian, notification of rights and grievance procedure, involvement of wards in decision making and other areas in which wards expressed comment, are reflected in the proposed rules.
•
The 2002 Economic Census – Wisconsin Geographic Series, compiled by the U.S. Census Bureau every 5 years for each year ending in "2" or "7" contains the latest available economic data compiled from businesses located in Wisconsin.
•
Criteria adopted by the Department and approved by the Wisconsin Small Business Regulatory Review Board to determine whether the Department's proposed rules have a significant economic impact on a substantial number of small businesses. Pursuant to the Department's criteria, a proposed rule will have a significant economic impact on a substantial number of small businesses and if operating expenditures, including annualized capital expenditures, increase by more than the prior year's consumer price index or revenues are reduced by more that the prior year's consumer price index. For the purposes of the rulemaking, 2007 is the index year. The consumer price index is compiled by the U. S. Department of Labor, Bureau of Labor Statistics and for 2007 is 4.2 percent.
•
Section
227.114 (1) (a)
, Stats., defines "small business" as a business entity, including its affiliates, which is independently owned and operated and not dominant in its field, and which employs 25 or fewer full-time employees or which has a gross annual sales of less than $5,000,000.
•
The DHS database that contains demographic, program and approval information for non-profit corporate guardians.
Analysis and supporting documents used to determine effect on small business
The North American Industry Classification System (NAICS) includes Corporate Guardianships in the Professional, Scientific, and Technical Services sector (sector 54) and further defined in sub-sector 54119 Other Legal Services. This industry comprises establishments of legal practitioners (except lawyers and attorneys) primarily engaged in providing specialized legal or paralegal services. The 2002 census lists 216 entities with total revenue over $25 million. Corporate guardians are a small portion of this sub-sector.
In November 2006, the Division of Quality Assurance (DQA) conducted a survey of the 72 corporate guardianship agencies operating in Wisconsin at that time. Partnering with the Wisconsin Guardianship Association, Coalition of Wisconsin Aging Groups and Disability Rights Wisconsin, Inc., DQA developed a survey that focused on key sections of the rule that had been identified for possible revision. The survey asked questions about the number and type of wards served, services provided, agency staffing, contact with wards, staff training, criminal background checks conducted by the agency and the operational structure. Over 50 percent of the agencies responded to the survey.
Data from DHS datasets lists 72 corporate guardians in Wisconsin.
Available data implies that most corporate guardians should be considered small business as defined in Section
227.114 (1) (a)
, Stats. Guardianships must be chartered as a non-profit entity authorized to conduct business in Wisconsin. DHS conducted a survey of corporate guardians with more then 50 percent of the agencies responding. DHS approves the number of wards that an agency can serve. The results of the survey reveal that 80 percent of agencies serve less then 100 wards.
Number of Wards Served
|
Percent of Agencies
|
20 Wards or less
|
52.00%
|
21 - 99 Wards
|
30.00%
|
100 or more Wards
|
18.00%
|
Financial data for corporate guardianships is not readily available. Based on an agency with 100 wards and 6 guardian representatives the following potential increased costs from DHS 85 were identified:
•
The proposed rule requires agencies to conduct criminal background checks for all employees who have contact with wards. The cost for the background check and staff time to complete the review is estimated at $22.00 per review. For an agency with 6 guardian representatives the cost will be $132.00 every 4 years (6 x $22) or $33.00 annually. The proposed rule requires background checks on paid staff only, volunteers are exempt. Based on DQA survey results, over half of the responding agencies indicated that background checks are already being performed on paid staff. Some agencies also complete criminal background checks on their volunteers.
•
The proposed rule will require that each new guardian representative receive initial training regarding their job responsibilities including information about the needs and services for wards they are assigned to, information about local resources to meet the needs of wards, prevention and reporting of abuse, neglect and misappropriation of property, ward's rights and the agency's policies and procedures including their grievance procedure. The rule does not require a specific number of hours for this training, however, initial training is estimated to require up to 40 hours. The cost of training is estimated at $28.00 per hour totaling $1,200 for each new guardian representative (40x$28). It is estimated that one new guardian representative will need this training at an average agency each year.
•
The proposed rule will require that each guardian representative complete 20 hours of continuing education training every 24 calendar months. Costs for training are estimated on 10 hours of continuing education training provided each year for 6 guardian representatives. Continuing education training is estimated to cost $56.00 per hour each for 6 guardian representatives totaling $3,360.00 (60x$56) annually. A large number of guardian representatives hold assorted credentials (social workers, attorneys, etc.) and are required by their licensure status to accrue a number of continuing education credits annually. These continuing education credits may be used to meet the requirement for continuing education in the proposed rule. Based on DQA survey results, many agencies already provide between 17-20 hours of training annually, exceeding the proposed rule.
•
The proposed rule will require agencies to have a photograph of each ward in its file. It is estimated that this requirement will cost $3.00 per ward. Options include a digital camera at $100.00, a disposable camera and 24 prints at $15.00, or individual passport photos at $3.00 per photo.
The Wisconsin Guardianship Association (WGA) is planning to offer training and workshops to all nonprofit corporate guardian agencies on meeting the new standards in the proposed rule. This training will include sample policies and procedures that agencies may choose to use and adapt to meet their agency's program. The WGA will also sponsor regular training/educational conferences for guardian representatives to meet the continuing education training requirement.
Many corporate guardians charge fees to wards or to counties for services provided. As costs for providing these services increase, including additional costs from revisions in DHS 85, fees may also be adjusted. It is unknown if the costs identified above will exceed the current consumer price index of 4.2 percent for any given agency, no single requirement appears to exceed this criteria. The fiscal impact of these additional requirements does not appear to be significant and will vary directly with the size of the agency. Agencies have the ability to increase fees charged to the wards or via the county court system; the overall effect of these proposed increases on corporate guardian agencies should be minimal.
Small Business Impact
Data from DHS data sets list 72 Corporate Guardianships in Wisconsin at this time. These entities must be "Nonprofit Corporations" as defined in s.
181.0103 (17)
Stats., namely a corporation, no part of the income which is distributed to its members, officers, or directors. The Department of Financial Institutions also requires Corporate Guardianships to be Non-stock corporations. The fiscal impact of the requirements noted above does not appear to be significant and will vary directly with the size of the agency. Agencies have the ability to increase fees charged to their wards or via the county court system; the overall effect of these proposed increases on corporate guardian agencies should be minimal. It is unknown if the costs identified above will exceed the current consumer price index of 4.2 percent for any given agency, no single requirement appears to exceed this criteria.
Small Business Regulatory Coordinator
Rosie Greer
608-266-1279
Fiscal Estimate
Summary
Available data implies that most corporate guardians should be considered small business as defined in Section
227.114 (1) (a)
, Stats. Guardianships must be chartered as a non-profit entity authorized to conduct business in Wisconsin. DHS conducted a survey of corporate guardians with more then 50 percent of the agencies responding. DHS approves the number of wards that an agency can serve. The results of the survey reveal that 80 percent of agencies serve less then 100 wards.
Number of Wards Served
|
Percent of Agencies
|
20 Wards or less
|
52.00%
|
21 - 99 Wards
|
30.00%
|
100 or more Wards
|
18.00%
|
Financial data for corporate guardianships is not readily available. Based on an agency with 100 wards and 6 guardian representatives the following potential increased costs from DHS 85 were identified:
•
The proposed rule requires agencies to conduct criminal background checks for all employees who have contact with wards. The cost for the background check and staff time to complete the review is estimated at $22.00 per review. For an agency with 6 guardian representatives, the cost will be $132.00 every 4 years (6 x $22) or $33.00 annually. The proposed rule requires background checks on paid staff only; volunteers are exempt. Based on DQA survey results, over half of the responding agencies indicated that background checks are already being performed on paid staff. Some agencies also complete criminal background checks on their volunteers.
•
The proposed rule will require that each new guardian representative receive initial training regarding their job responsibilities including information about the needs and services for wards they are assigned to, information about local resources to meet the needs of wards, prevention and reporting of abuse, neglect and misappropriation of property, ward's rights and the agency's policies and procedures including the their grievance procedure. The rule does not require a specific number of hours for this training, however, initial training is estimated to require up to 40 hours. The cost of training is estimated at $28.00 per hour totaling $1,200 for each new guardian representative (40x$28). It is estimated that one new guardian representative will need this training at an average agency each year.
•
The proposed rule will require that each guardian representative complete 20 hours of continuing education training every 24 calendar months. Costs for training are estimated on 10 hours of continuing education training provided each year for 6 guardian representatives. Continuing education training is estimated to cost $56.00 per hour each for 6 guardian representatives totaling $3,360.00 (60x$56) annually. A large number of guardian representatives hold assorted credentials (social workers, attorneys, etc.) and are required by their licensure status to accrue a number of continuing education credits annually. These continuing education credits may be used to meet the requirement for continuing education in the proposed rule. Based on DQA survey results, many agencies already provide between 17 – 20 hours of training annually, exceeding the proposed rule.
•
The proposed rule will require agencies to have a photograph of each ward in its file. It is estimated that this requirement will cost $3.00 per ward. Options include an inexpensive digital camera at $100.00, a disposable camera and 24 prints at $15.00, or individual passport photos at $3.00 per photo.
The Wisconsin Guardianship Association (WGA) is planning to offer training and workshops to all nonprofit corporate guardian agencies on meeting the new standards in the proposed rule. This training will include sample policies and procedures that agencies may choose to use and adapt to meet their agency's program. The WGA will also sponsor regular training/educational conferences for guardian representatives to meet the continuing education training requirement.
Many corporate guardians charge fees to wards or to counties for services provided. As costs for providing these services increase, including additional costs from revisions in DHS 85, fees may also be adjusted. It is unknown if the costs identified above will exceed the current consumer price index of 4.2 percent for any given agency, no single requirement appears to exceed this criteria. The fiscal impact of these additional requirements does not appear to be significant and will vary directly with the size of the agency. Agencies have the ability to increase fees charged to the wards or via the county court system; the overall effect of these proposed increases on corporate guardian agencies should be minimal.
State fiscal effect
None.
Local government fiscal effect
Indeterminate. Increase costs.
Local government units affected
Counties.
Private sector fiscal effect
Indeterminate. Increase revenues and Increase costs. Costs will not have significant economic impact on a substantial number of small businesses.
Long-range fiscal implications
None anticipated.
Text of Proposed Rule
SECTION 1. Chapter DHS 85 is repealed and recreated to read:
Chapter
DHS 85
Private Non-profit Corporations and Unincorporated Associations as Guardians
Subchapter I — General Provision
s
DHS 85.01 Purpose and authority.
This chapter is promulgated under the authority of s.
54.15 (7)
, Stats., and ch.
227.11 (2) (a)
, Stats., to establish the criteria by which the department determines whether a private nonprofit corporation organized under ch.
181
,
187
, or
188
, Stats., or an unincorporated association is suitable to perform the duties of a guardian of the person, or of the estate, or both, of a proposed ward.
DHS 85.02 Applicability.
This rule applies to private non-profit corporations or unincorporated associations applying to the department for consideration of suitability to perform the duties of guardian of a person or of an estate, or both, of a proposed ward.
DHS 85.03 Definitions.
As used in this chapter:
(1) "Applicant" means a private nonprofit corporation or an unincorporated association that applies to the department for a finding of suitability to perform the duties of a corporate guardian.
(2) "Corporate guardian" or "guardian" means a private nonprofit corporation or an unincorporated association appointed by a court to serve as guardian of the person, or of the estate, or both, of an individual who is found by a court to be in need of a guardian.
(3) "Department" means the Wisconsin department of health services.
(4) "Guardian of the estate" has the meaning given under s.
54.01 (11)
, Stats.,
(5) "Guardian of the person" has the meaning given under s.
54.01 (12)
, Stats.
(6) "Guardianship program" means a system that is established by a corporate guardian to manage the income and assets and provide for the essential requirements for health and safety and the personal needs of its wards under ch.
54
, Stats.
(7) "Guardianship program manager" means an employee designated by a corporate guardian, who is responsible for the management and day–to-day operation of the guardianship program.
(8) "Guardian representative" means an individual assigned by a guardian to perform the functions of the guardian of the person under s.
54.25 (1)
and
(2)
, Stats., or of the estate under s.
54.19
and
54.20
, Stats., or both, of a ward.
(9) "Successor guardian" has the meaning given in s.
54.01 (35)
, Stats.
(10) "Unincorporated association" is an organization organized under ch.
184
, Stats.
(11) "Ward" has the meaning given under s.
54.01(37)
, Stats.
DHS 85.04 Waivers and variances.
(1) DEFINITIONS. In this section:
(a) "Variance" means the granting of an alternate requirement in place of a requirement of this chapter.
(b) "Waiver" means the granting of an exemption from a requirement of this chapter.
(2) REQUIREMENTS FOR WAIVERS AND VARIANCES. The department may grant a waiver or variance of a requirement of this chapter to the corporate guardian
if the department finds that the waiver or variance will not adversely affect the health, safety, or welfare of any ward and that:
(a) Strict enforcement of a requirement would result in unreasonable hardship on the ward.
(b) An alternative to a requirement, including a new concept, method, procedure or technique, other equipment, other personnel qualifications, or the conducting of a pilot project, is in the interests of better care or management.
(3) APPLYING FOR A WAIVER OR VARIANCE. A corporate guardian may apply for a waiver or variance at any time. Each request shall be made in writing to the department and include all of the following:
(a) The rule provision from which the waiver or variance is requested.
(b) The time period for which the waiver or variance is requested.
(c) If the request is for a variance, the specific proposed alternative action.
(d) The reasons for the request.
(e) Justification that a requirement under sub. (2) would be satisfied.
(f) Any other information requested by the department.
(4) DEPARTMENT DECISION
.
(a) The department shall grant or deny each request for waiver or variance in writing. A notice of denial shall contain the reasons for denial. If a notice of denial is not issued within 60 days after the receipt of a complete request, the waiver or variance shall be automatically approved.
(b) The terms of a requested variance may be modified upon agreement between the department and the corporate guardian.
(c) The department may impose conditions on the waiver or variance which it deems necessary.
(d) The department may limit the duration of a waiver or variance.
(5) HEARINGS.
(a) Denial of a request for a waiver or variance may be contested by requesting a hearing as provided by ch.
227
, Stats.
(b) The licensee shall sustain the burden of proving that the denial of a waiver or variance was unreasonable.
(6) REVOCATION
.
The department may revoke a waiver or variance for any of the following reasons:
(a) The department determines that the waiver or variance is adversely affecting the health, safety or welfare of the wards.
(b) The guardian has failed to comply with the waiver or variance as granted.
(c) The licensee notifies the department in writing of the desire to relinquish the waiver or variance and be subject to the requirement previously waived or varied.
(d) Revocation is required by a change in law.
Subchapter II — Approvals
DHS 85.05 Application.
(1) APPLICATION. Only a private nonprofit corporation or an unincorporated association may apply to the department for a determination that the corporation or association is suitable to perform the duties of a guardian. A corporation or association applying for such a determination shall apply to the department on an application form provided by the department. The applicant shall submit the completed application and all of the following to the department:
(a) The filed endorsement of the Articles of Incorporation submitted to the Wisconsin department of financial institutions, if applicable.
(b) A copy of the applicant's written grievance procedure for use by wards and interested parties.
(c) A business plan that includes staffing projections.
(d) Any additional information requested by the department.
DHS 85.06 Criteria for approval.
The department may not approve an applicant until the department determines the applicant is fit and qualified to receive a determination of suitability to perform the duties of a corporate guardian. In determining whether an applicant is fit and qualified, the department may consider all of the following:
(1) Compliance history with Wisconsin's or any other state's licensing requirements and with any federal certification requirements, including any license revocation or denial.
(2) Arrest history and criminal record, including any of the following:
(a) Crimes or acts involving abuse, neglect or mistreatment of a person or misappropriation of property of the person.
(b) Crimes or acts related to the manufacture, distribution, prescription, use, or dispensing of a controlled substance.
(c) Fraud or substantial or repeated violations of applicable laws and rules in the operation of any health care facility or in the care of dependent persons.
(d) A conviction or pending criminal charge which substantially relates to the care of adults or minors, to the funds or property of adults or minors, or to the operation of a residential or health care facility or agency.
(3) Financial stability, including all of the following:
(a) Financial history and financial viability of the owner or related organization.
(b) Outstanding debts or amounts due to the department or other government agencies, including unpaid forfeitures and fines.
DHS 85.07 Change of ownership.
(1) If a corporate guardian sells or otherwise transfers ownership of the corporation or the association, the guardian shall notify each of its wards, the department, the court, designated counties, and all agencies or persons serving the ward in writing at least 30 days before the final transfer of ownership. This notice shall include the name and contact information of the new corporation.
(2) The corporate guardian shall remain responsible for each ward until a successor guardian is appointed by the court.
(3) The corporate guardian shall transfer the original records of its wards to the successor guardian appointed by the court.
DHS 85.08 Corporate guardian closing.
(1) If a guardian is a corporation and the corporation's corporate status is revoked by the department of financial institutions or is voluntarily or involuntarily dissolved, or if the guardian is an unincorporated association and the association's status is voluntarily or involuntarily dissolved by the members or a court, or becomes inactive, the guardian shall notify each of its wards, the department, the court, designated counties, and all agencies or persons serving the ward in writing at least 30 days before the corporation closes.
(2) The corporate guardian shall remain responsible for each ward until a successor guardian is appointed by the court.
(3) The corporate guardian shall transfer the original records of its wards to the successor guardian appointed by the court.
Subchapter III — Personnel
DHS 85.09 Staff.
(1) GUARDIANSHIP PROGRAM MANAGER (a) The guardian shall designate an employee who is 21 years or older and is fit and qualified under s.
50.03 (4)
, Stats., to manage its guardianship program.
(b) The guardianship program manager shall have a high school diploma or equivalency and have at least 3 years of relevant experience.
(c) The guardianship program manager shall be responsible for the ongoing training and competency of all employees.
(d) Any change of guardianship program manager shall be communicated to the department and the county department designated under s.
55.02
, Stats., within 14 days following the effective date of the change.
(
2) OTHER EMPLOYEES. (a) Except at provided in sub. (1) (a) each employee shall have the skills, education and ability to fulfill the employee's job requirements.
(b) An employee that has direct contact with a ward shall be at least 18 years old.
(3) BACKGROUND CHECK. At the time of hire, employment or contract and every four years after, the corporate guardian shall conduct and document a caregiver background check on each employee following the procedures in s.
50.065
, Stats., and ch.
DHS 12
. A guardian may not employ or contract with a person who has been convicted of the crimes or offenses, or has a governmental finding of misconduct found in s.
50.065
, Stats., and ch.
DHS 12
, Appendix
A
, unless the person has been approved under the department's rehabilitation review process as defined in ch.
DHS 12
.
(4) EMPLOYEE RECORDS. A separate record for each employee shall be maintained, kept current, and include all of the following:
(a) A written job description including duties, responsibilities and qualifications required for the employee.
(b) Beginning date of employment.
(c) Educational qualifications, relevant experience.
(d) The results of the background checks required under sub. (3).
(e) Documentation of training.
(5) VOLUNTEERS. The guardian may use volunteers if the volunteer receives the orientation and training necessary to assure the health, safety and welfare of wards.
DHS 85.10 Training.
(1) INITIAL TRAINING. Before performing the duties of a guardian, each guardian representative shall receive training that includes all of the following:
(a) Job responsibilities.
(b) Prevention and reporting of ward abuse, neglect and misappropriation of ward property.
(c) Ward's rights and grievance procedures contained in chs.
54
and
55
, Stats., s.
DHS 85.13
, and ch.
DHS 94
.
(d) Information regarding the needs and services for each ward for whom the guardian representative is responsible.
(e) Information about local resources available to meet the needs of wards.
(f) Agency policies and procedures.
(2) CONTINUING EDUCATION. Each guardian representative shall complete 20 hours of training every 24 calendar months. The training shall be relevant to the guardian representative's job assignment and designed to increase the effectiveness of the employee to meet the needs of the wards served.
DHS 85.11 Staffing.
(1) The guardian shall at all times have an adequate number of staff who are qualified either by training or by experience to meet the needs of its wards, including knowledge of service needs and resources for meeting service needs.
(2) The guardian representative shall be accessible to the ward and to other persons concerned about the ward's well-being.
(3) The corporate guardian shall have staff available at all times to respond to an emergency situation as defined in s.
DHS 94.02 (14)
.
(4) The corporate guardian shall have staff accessible to the local planning agency or interagency mechanism designated under s.
55.02
, Stats.
DHS 85.12 Conflict of interest.
(1) The corporate guardian may not be subject to undue influence from any party.
(2) When the corporate guardian is a part of a larger organization, the corporate guardian shall have designated staff with independent decision-making authority about the guardianship program.
(3) Pursuant to s.
55.03 (1)
, Stats., a guardian may not be a provider of protective services or protective placement for its ward.
(4) No corporate guardian may accept a guardianship from a court in a county in which a member of the corporate guardian's board of directors or any employee or volunteer of the corporate guardian is a member or employee of the community board organized under ss.
46.23
,
51.42
or
51.437
, Stats., or an employee of the county department of social services or human services or community programs or county board of supervisors or department of aging.
(5) A corporate guardian may not profit from their ward.
(6) The guardian shall not commingle personal or corporate funds with the funds of the ward. The guardian may consolidate and maintain wards' funds in accounts with other wards' funds if the guardian keeps separate and complete accounting of each ward's funds.
(7) Pursuant to s.
54.18 (3) (b)
, Stats., the corporate guardian may not lend funds of the ward to another individual or to an entity, unless the court first approves the terms, rate of interest, and any requirement for security.
(8) The corporate guardian may not engage in any financial transaction involving the ward's estate except as permitted under ch.
54
, Stats., and this chapter.
Subchapter IV — Ward Services
DHS 85.13 Rights of wards.
(1) Subject to the provisions of any court order regarding the division of power and authority between the guardian and the ward, and subject to any other provision of law, including ss.
54.18
through
54.25
, Stats., every ward shall have the right to all of the following:
(a) Be treated with respect and dignity by the staff and volunteers of the corporate guardian.
(b) Be free from abuse, mistreatment, neglect and misappropriation of property.
(c) Confidentiality of health and personal information and records.
(d) Be informed of the services provided by the corporate guardian agency.
(e) Be consulted about decisions on the ward's behalf, to the extent the ward is capable.
(f) Have guardianship services provided in a way that constitutes the least restrictive intervention.
(g) Communicate freely with the advocate of the ward's choice.
(h) File a grievance or a complaint without retaliation.
DHS 85.14 Duties.
(1) The guardian representative shall meet with the ward within 14 days of the court appointment as corporate guardian. At the first meeting, the guardian representative shall complete all of the following:
(a) Explain to the ward the role of the guardian.
(b) Explain the guardianship determination and order including the rights addressed by the court. The guardian representative shall be familiar with the provisions of the court order as they relate to limitations on the rights of the ward and those rights which are retained. The guardian representative shall explain to the ward the provisions of the court order as they relate to limitations on the rights of the ward and those rights which are retained.
(d) Explain how to file a grievance and how to obtain a written copy of the grievance procedures for the living arrangement or for a service provider and the guardianship program.
(2) The guardian representative shall notify relevant agencies and individuals of the appointment guardianship and shall provide letters of guardianship to the ward's service providers and others, as necessary.
(3) If a medical evaluation was not completed within the past year, the guardian shall obtain an evaluation of the ward's condition, treatment, and functional status from the ward's treating physician, or appropriate treatment provider.
(4) The guardian representative shall fulfill the duties of a guardian of person pursuant to ss.
54.18 (2)
and
(3)
and
54.25 (1)
, Stats. The guardian representative shall fulfill the powers assigned by the court and shall exercise only those powers granted to them by the court pursuant to s.
54.25 (2)
, Stats. A guardian representative shall be aware of and, if applicable, advocate for the ward's rights under ss.
50.09
and
51.61
, Stats., and shall advocate for the least possible restrictions on the ward's liberty and exercise of constitutional and statutory rights, pursuant to ss.
54.18 (2)
and
54.25 (2) (d) 3.
, Stats.
(5) A guardian representative of the estate shall fulfill the duties of a guardian of the estate pursuant to ss.
54.18 (2)
and
(3)
,
54.19
, and
54.20 (1)
, Stats. A guardian representative shall fulfill the powers assigned by the court pursuant to s.
54.20
, Stats., and shall seek court approval for those powers requiring court approval pursuant to s.
54.20 (2)
, Stats. In seeking compensation or reimbursement from the ward's funds, a guardian representative must ensure that any payments sought or received will not prevent the corporate guardian from providing adequately for the personal needs of the ward from the ward's available assets and income, including any available public benefits.
(6) A corporate guardian must obtain court approval prior to receiving any compensation or reimbursement from the wards funds, pursuant to s.
54.72
, Stats. In seeking compensation or reimbursement from the ward's funds, a corporate guardian must ensure that any payments sought or received will not prevent the corporate guardian from providing adequately for the personal needs of the ward from the ward's available assets and income, including any available public benefits.
(7) For a guardian of person, the guardian representative shall have face-to-face contact with the ward at least once every 3 months and more often as needed to meet the needs of the ward. The guardian representative shall take necessary action to see that the ward receives needed services, and to assure that the ward is well treated, properly cared for, and is provided with the opportunity to exercise legal rights. The guardian representative shall visit the ward in their residence at least annually.
(8) For guardian of estate, the guardian representative shall have personal contact every 3 months and more often as needed to meet the needs of the ward. The guardian representative shall take necessary action to see that the ward receives needed services, and to assure that the ward is well treated, properly cared for, and is provided with the opportunity to exercise legal rights. The guardian representative shall have face-to-face contact with the ward at least annually.
DHS 85.15 Records.
(1) The corporate guardian shall maintain a separate file for each ward including all of the following information and documents as applicable:
(a) Name, date of birth, address, telephone number, and social security number. Guardians of person shall also maintain information regarding the ward's medical coverage, physician, diagnoses, medications, and allergies to medications.
(b) A current photograph of the ward.
(c) All relevant legal documents involving the ward.
(d) Advance directives.
(e) A list of key contacts.
(f) A list of service providers, contact information, a description of services provided to the ward and progress reports as applicable.
(g) Documentation of all ward and collateral contacts, including the date, time, and activity.
(h) Progress notes that are as detailed as necessary to reflect contacts made and work done regarding the ward.
(i) A guardianship inventory, accounts and annual reports as required by statute, including all supporting financial statements, records and financial reports.
(j) Assessments regarding the ward's past and present medical, psychological, and social functioning, including relevant family medical information.
(k) Documentation of the ward's known values, preferences, and wishes regarding medical and other care and services including all advanced directives made prior to guardianship, and financial matters and other services.
(L) A personal and social history of the ward including a family history.
(2) If guardianship is transferred, the corporate guardian shall transfer the original record required in this section to the successor guardian.
Subchapter V — Withdrawal of Approval
DHS 85.16 Actions affecting approval.
(1) If at any time the department determines that a corporate guardian no longer meets the criteria under this chapter, the department may withdraw its approval upon 30 day written notice to all of the following:
(a) Corporate guardian.
(b) All courts that assigned the corporate guardian's guardianships.
(c) The ward.
(d) The ward's family.
(e) Any other interested parties.
(f) The county agency designated under s.
55.02
, Stats.
(2) The corporate guardian shall comply with the provisions in s.
DHS 85.08 (2)
regarding a corporate guardian closing.
DHS 85.17 Appeal of decisions.
Any party adversely affected by a decision of the department about the suitability of a private non-profit corporation or an unincorporated association for corporate guardianship may appeal that decision to the department of administration's division of hearings and appeals under ss.
227.42
and
227.44
to
227.50
, Stats. The request for a hearing shall be filed with the department of administration's division of hearings and appeals within 10 working days after receipt of the notice of denial. The request for hearing is considered filed when the request is received by that division.
Note: To appeal a decision by the department, send a request for a hearing to Division of Hearings and Appeals, P.O. Box 7875, Madison, WI 53707.
Notice of Hearings
Health Services
Health, Chs. DHS 110—
NOTICE IS HEREBY GIVEN that pursuant to ss.
227.11 (2) (a)
,
254.34 (1) (a)
,
254.365 (4)
and
254.37 (3)
, Stats., the Department of Health Services will hold public hearings to consider the proposed creation, repeal, renumbering and amendment of portions of Chapter
DHS 157
, Radiation Protection, relating to the regulation of radiation producing devices and radioactive materials, and affecting small businesses.
Hearing Information
Date and Time
|
Location
|
October 13, 2009
Tuesday
10:00 to 11:30 AM
|
Medical College of Wisconsin
8701 Watertown Plank Rd.
Room H1250
Milwaukee, WI
|
October 14, 2009
Wednesday
10:00 to 11:30 AM
|
Department of Health Services
1 W. Wilson Street
Room B139
Madison, WI
|
Accessibility
English
DHS is an equal opportunity employer and service provider. If you need accommodations because of a disability or need an interpreter or translator, or if you need this material in another language or in an alternate format, you may request assistance to participate by contacting Paul Schmidt at 608 267-4792 or
paul.schmidt@dhs.wisconsin.gov
. You must make your request at least 7 days before the activity.
Spanish
DHS es una agencia que ofrece igualdad en las oportunidades de empleo y servicios. Si necesita algún tipo de acomodaciones debido a incapacidad o si necesita un interprete, traductor o esta información en su propio idioma o en un formato alterno, usted puede pedir asistencia para participar en los programas comunicándose con Paul Schmidt al número 608 267-4792 or paul.schmidt@dhs. wisconsin.gov. Debe someter su petición por lo menos 7 días de antes de la actividad.
Hmong
DHS yog ib tus tswv hauj lwm thiab yog ib qhov chaw pab cuam uas muab vaj huam sib luag rau sawv daws. Yog koj xav tau kev pab vim muaj mob xiam oob qhab los yog xav tau ib tus neeg pab txhais lus los yog txhais ntaub ntawv, los yog koj xav tau cov ntaub ntawv no ua lwm hom lus los yog lwm hom ntawv, koj yuav tau thov kev pab uas yog hu rau Paul Schmidt ntawm 608 267-4792 or
paul.schmidt@dhs.wisconsin.gov
. Koj yuav tsum thov qhov kev pab yam tsawg kawg 7 hnub ua ntej qhov hauj lwm ntawd.
Agency Contact Person
Paul Schmidt, Chief
Radiation Protection Section
P.O. Box 2659
Madison, WI 53701-2659
608-267-4792
Submission of Written Comments
Comments may be submitted to the agency contact person that is listed above. The deadline for submitting comments is October 21, 2009.
Analysis Prepared by the Department of Health Services
Statutes interpreted
Statutory authority
Explanation of agency authority
As specified under s.
254.34 (1)
, Stats., the Department is the state radiation control agency and is required under ss.
254.34 (1) (a)
,
254.365 (4)
, and
254.37 (3)
, Stats., to promulgate rules pertaining to the use of radiation in Wisconsin. Specifically, the Department is required to promulgate and enforce rules pertaining to sources of ionizing radiation and for registration and licensing sources of ionizing radiation, and enforcement as may be necessary to prohibit and prevent unnecessary radiation exposure. The Department's rules for by-product material, source material, and special nuclear material are required to be in accordance with
42 USC 2021
(o) and be otherwise compatible with the requirements under
42 USC 2011
to
2114
and regulations adopted under
42 USC 2011
to
2114
.
Related statute or rule
Chapter
NR 809
incorporates the radioactivity standards for community water systems and the analytical methods established in ss.
DHS 157.95
and
157.96
. The Department of Natural Resources applies these standards to community drinking water systems.
Chapter
DHS 163
establishes requirements for identification, removal and reduction of lead-based paint hazards. Lead in paint analysis requires use of a portable device containing radioactive material which is required to be licensed under ch.
DHS 157
. Section
DHS 157.05 (4)
requires that any person providing training for certified lead inspectors or risk assessors to meet the training requirements of s.
DHS 163.24
(a) 1. and 3. and to complete an additional 8 hours of radiation safety training.
Plain language analysis
Under s.
254.34 (1) (a)
Stats., the Department is responsible for developing and enforcing rules, including registration and licensing of sources of ionizing radiation, to prohibit and prevent unnecessary radiation exposure. The Department is also responsible for maintaining compliance with the Agreement signed by Governor Doyle in 2003 and the Nuclear Regulatory Commission (NRC) that transferred regulatory authority over certain radioactive materials from the NRC to the state. Under the Agreement, the Department is responsible for licensing and inspecting radioactive materials commonly used in medicine, industry, research and education. NRC staff periodically evaluate the state regulatory program.
One of the requirements of this Agreement is Wisconsin's assurance that it will revise the radioactive material portions of ch.
DHS 157
within 3 years of any applicable changes in Title10 Code of Federal Regulations. Title 10 CFR has been revised since ch.
DHS 157
was last revised in 2006. Therefore, the Department proposes to modify the radioactive material requirements in ch.
DHS 157
.
In addition, the Department proposes to revise the portions of ch.
DHS 157
pertaining to x-rays to reflect new diagnostic and therapeutic technologies, experience with implementing the current rule, changes in comparable federal regulations in
21 CFR Part 1020
, and input provided to the Department by an advisory group that included representatives of academic and medical facilities, radioactive materials users, x-ray users and large and small businesses.
The proposed revisions to ch.
DHS 157
accomplish the following:
•
Update the radiation protection and regulatory requirements for radioactive materials to reflect changes in federal regulations in Title 10, Code of Federal Regulations Parts 19, 20, 31, 33-36, 39, 40, 70, 71 and 150 and applicable portions of Title 49 (transportation), Code of Federal Regulations.
•
Incorporate new security requirements for certain radioactive materials, initially implemented nationally under order of the Nuclear Regulatory Commission.
•
Update the radiation safety requirements for x-ray producing devices to reflect new diagnostic and therapeutic technologies, current federal regulation and the input of an ad hoc advisory group representing a cross-section of regulated users.
•
Revise operator qualifications for fluoroscopy machines.
•
Incorporate minor corrections to rule language based on the Department's experience administering the current rule.
•
Incorporate minor revisions to operator qualification, shielding and quality testing requirements.
Comparison with federal regulations
Wisconsin's Agreement with the Nuclear Regulatory Commission requires the Department to incorporate relevant changes to federal radioactive material regulations into its radiation protection rules within 3 years of the effective date of the federal regulations. The proposed changes to ch.
DHS 157
ensure continued compatibility with new federal radioactive material regulations in 10 CFR Pts. 19, 20, 31, 33-36, 39, 40, 70, 71 and 150 and applicable parts of Title 49 CFR relating to transportation as required by s.
254.34 (1)
, Stats.
Comparison with rules in adjacent states
Illinois
Illinois is an Agreement state with the Nuclear Regulatory Commission. As a result, Illinois law contains radiation protection and regulatory requirements very similar to those in ch.
DHS 157
and compatible with equivalent federal regulations in Titles 10 and 49, Code of Federal Regulations.
Iowa
Iowa is an Agreement state with the Nuclear Regulatory Commission. As a result, Iowa law contains radiation protection and regulatory requirements very similar to those in ch.
DHS 157
and compatible with equivalent federal regulations in Titles 10 and 49, Code of Federal Regulations.
Michigan
Michigan is not an Agreement state with the Nuclear Regulatory Commission. However, Michigan has formally declared its intent to become an agreement state with the Nuclear Regulatory Commission. As a result, Michigan law does not contain regulations equivalent to most of ch.
DHS 157
. The Nuclear Regulatory Commission is currently responsible for regulating the majority of radioactive material use in Michigan under Titles 10 and 49, Code of Federal Regulations.
Minnesota
Minnesota is an Agreement state with the Nuclear Regulatory Commission. Minnesota adopted new radiation protection regulations for radioactive materials effective January 1, 2005. As a result, Minnesota law contains radiation protection and regulatory requirements very similar to those in ch.
DHS 157
and compatible with equivalent federal regulations in Titles 10 and 49, Code of Federal Regulations.
Summary of factual data and analytical methodologies
The methods specified in s.
227.114
,
(2)
, Stats., for reducing a rule's impact on small business have not been incorporated in the proposed rules because incorporating any methods may be contrary to the explicit state statutory requirements for radiation control, federal regulatory and statutory requirements for radiation control, Agreement state requirements, and the state's public policy on radiation control stated in s.
254.33
, Stats. Because of the Department's limited use of discretion in developing the content of the proposed rules, the Department has limited its analysis of the proposed rules affect on the small businesses regulated by ch.
DHS 157
to the affect that the proposed revisions in x-ray regulatory requirements will have on those businesses.
The Department referred to all of the following to draft the proposed rules and the small business fiscal impact analysis:
1. The input of an ad hoc rules advisory group that included representatives of academic and medical facilities, radioactive materials users, x-ray users and large and small businesses.
2. An Agreement state rule template called the "Suggested State Regulations for the Control of Radiation" (SSRCR) developed by the Conference of Radiation Control Program Directors, Inc. (CRCPD). The CRCPD is a national organization of primarily state radiation control staff that supports and represents state radiation control programs. The SSRCR is developed with the involvement of federal radiation agencies, such as the Nuclear Regulatory Commission, the Food and Drug Administration and the Environmental Protection Agency. The SSRCR is also continually updated and used by most of the 35 existing Agreement states to help meet federal requirements.
3. Requirements of Titles 10, 21, and 49 of the Code of Federal Regulations; 42 USC; ss.
254.31
to
254.45
, Stats., and the Agreement between Wisconsin and the Nuclear Regulatory Commission.
4. The 2002 Economic Census – Wisconsin Geographic Series, which is compiled by the U.S. census bureau every 5 years for each year ending in "2" and "7". The U.S. census bureau is currently compiling the 2007 census information. This information will not become fully available until 2010. The information provided by the Economic Census includes the North American Industry Classification Codes, information on industries, business revenues, sizes, and employment. The Department used this information to approximate business size and any possible percentage increase in business costs due to the proposed revisions in x-ray regulatory requirements.
5. Criteria adopted by the Department and approved by the Wisconsin Small Business Regulatory Review Board to determine whether the Department's proposed rules have a significant economic impact on a substantial number of small businesses. Pursuant to the Department's criteria, a proposed rule will have a significant economic impact on a substantial number of small businesses if at least 10% of the businesses affected by the proposed rules are small businesses and if operating expenditures, including annualized capital expenditures, increase by more than the prior year's consumer price index (CPI) or reduce revenues by more than the prior year's CPI. For the purposes of this rulemaking, we used 2008 as the index year; the 2008 CPI is estimated to be 3.8%. The consumer price index is compiled by the U.S. Department of Labor, Bureau of Labor Statistics and measures, among other things, the rate of inflation.
6. Section
227.114 (1) (a)
, Stats., which defines "small business" as a business entity, including its affiliates, which is independently owned and operated and not dominant in its field, and which employees 25 or fewer full-time employees or which has gross annual sales of less than $5,000,000.
Analysis and supporting documents used to determine effect on small business
The Department is the state's radiation control agency and is required under ss.
254.34 (1) (a)
,
254.365 (4)
, and
254.37 (3)
, Stats., to promulgate rules pertaining to the use of radiation in Wisconsin. Specifically, the Department is required to promulgate and enforce rules pertaining to sources of ionizing radiation, for registration and licensing sources of ionizing radiation, and to prohibit and prevent unnecessary radiation exposure.
The Department's x-ray registration and inspection program, and radioactive materials licensing and inspection program, are both 100% fee supported by the annual fees authorized under ss.
254.35 (3)
and
254.365 (5)
, Stats. There are no fee increases proposed in this rule revision.
DHS 157.74 (2) (L).
This new subsection requires radiation safety committee oversight of all facilities that have 2 or more therapeutic radiation machines, regardless of the type of device (external or internal) used. The requirement for a radiation safety committee already exists for radioactive materials under s.
DHS 157.61 (1) (e)
. The majority of therapeutic radiation machines currently being used in Wisconsin are used at large medical facilities that do not qualify as small businesses under s.
227.114 (1) (a)
, Stats. and have existing radiation safety committees. In the event that a facility without a radiation safety committee acquires 2 or more therapeutic radiation machines, they can utilize existing staff to form a radiation safety committee required under this section. As a result, the Department expects this new requirement to have minimal impact on any facility, including small business.
DHS 157.76 (11).
Fluoroscopy devices, used to obtain continuous x-ray images of the body, produce very high radiation exposure rates with exposure time directly controlled by the device operator. The Department is aware of fluoroscopy operators receiving substantial exposure from use of fluoroscopic devices, indicating a lack of awareness of safety requirements. As a result, the Department is proposing minimum training for all personnel that operate fluoroscopy devices, regardless of the type of facility. This new requirement will impact the small percentage (less than 10%) of medical clinics, chiropractic and veterinary facilities with fluoroscopy devices, all of which are classified as a small businesses under s.
227.114 (1) (a)
, Stats. The proposed training requirement will also affect all large hospitals and clinics that routinely utilize fluoroscopy by requiring physicians as well as other operators to complete minimum training. The proposed training will take a minimum of 8 hours to complete. This training can be accomplished in a variety of ways, including in house (on site) training and continuing education, and can be rolled into the business' existing training infrastructure. As a result, the Department expects there will be a small cost associated with this training to all facilities using fluoroscopy devices, including small business.
DHS 157.76 (12).
The Department is proposing requiring fluoroscopy units to have their radiation output measured annually by a qualified person on staff or under contract. This is consistent with the recommendations of the Conference of Radiation Control Program Directors (CRCPD) in their suggested state regulations. There is minimal effort required to meet this requirement because fluoroscopy units already have either qualified staff or contractors on hand. As a result, the Department anticipates minimal fiscal impact on any facility, including small business.
DHS 157.80 (2) (a) 2.
The Department is proposing that operators of computed tomography (CT) x-ray systems for veterinary use be qualified or otherwise trained to use the device. This requirement will apply to all veterinary facilities using CT x-ray systems, which is currently a very small percentage of the total facilities statewide (approximately 4 sites). The small number of veterinary facilities impacted by this requirement are classified as a small business. The proposed training can be obtained from a device vendor or other qualified staff. To the Department's knowledge, the few veterinary facilities with CT x-ray systems already meet this requirement. Due to the very small number of impacted facilities and the access to training, the Department anticipates minimal fiscal impact to small businesses.
DHS 157.82 (2) and (5).
These 2 subsections jointly require all electronic brachytherapy users to receive device specific training prior to operating this new technology. The proposed training is consistent with the requirements for other therapeutic radiation machines in ch.
DHS 157
. Currently, this new technology is not being used by any facility classified as a small business under s.
227.114 (1) (a)
, Stats.
DHS 157.85 (13), (14), (16).
These subsections establish quality assurance requirements for electronic brachytherapy devices as recommended by a national organization, the American Association of Physicists in Medicine (AAPM). Currently, this new technology is not being used by any facility classified as a small business under s.
227.114 (1) (a)
, Stats.
Small Business Impact
Pursuant to the foregoing analysis, the Department does not anticipate that the proposed revisions will have a significant economic impact on small businesses.
Small business regulatory coordinator
Rosie Greer
(608) 266-1279
Fiscal Estimate
Summary
Under s.
254.34 (1) (a)
, Stats., the Department of Health Services is responsible for developing and enforcing rules, including registration and licensing of sources of ionizing radiation. Sources of ionizing radiation include x-ray producing devices. The Department is also responsible for maintaining compliance with an agreement between Wisconsin and the federal Nuclear Regulatory Commission (NRC) that transferred regulatory authority over certain radioactive materials from the NRC to the state.
The current rule revision is intended to bring Wisconsin into compliance with the most recent changes to federal radiation protection and regulatory requirements. No fiscal effect is anticipated as a result of the incorporation of new federal standards into DHS 157.
In addition, the Department proposes to update certain radiation safety requirements. Since the last revision of DHS 157 in 2006, new x-ray technologies with potential for significant radiation exposures to operators and patients have become more prevalent in the state. This rule revision proposes operator qualification and safety requirements for these new technologies. The new x-ray technologies are primarily being used by large, medical facilities not classified as a small business under s 227.114 (1) (a), Stats. In a few cases, they are being used by a small subset of veterinary facilities that are classified as a small business. The training needed to become qualified to operate these new technologies is available and may be accomplished in-house by incorporating into existing radiation safety programs. Some facilities are already providing operator training to meet facility requirements. Any additional training cost will vary by facility, but is not expected to be significant for any facility.
The Department is also proposing new quality assurance requirements for the digital x-ray systems that are being increasingly used in medical, dental, chiropractic and podiatric offices within the state. Digital x-ray systems use a digital (i.e., electronic) image receptor that replaces the use of x-ray film. The Department does not expect a significant cost to any facility from these new requirements.
Finally, the Department is proposing minimum training for all operators of fluoroscopy devices, including physicians. Fluoroscopy devices produce a continuous x-ray image of the body with potential for significant radiation exposure to both the patient and medical personnel. Fluoroscopy devices are used by most hospitals, plus a small subset of medical clinics, chiropractic and veterinary facilities. Although there will be a cost to complete the operator qualification training, either thru formal continuing education or in-house training, it is anticipated that there will be only a minimal fiscal impact to any facility.
The proposed changes to x-ray safety requirements are not the result of the changes in federal standards, although the changes are consistent with safety standards recommended by national organizations, specifically the American Association of Physicists in Medicine (AAPM) and the Conference of Radiation Control Program Directors (CRCPD). The new standards can be incorporated into the training required of most occupations that use radiation producing devices and thus is not expected to be a significant additional cost to any facility or individual. The Department is not proposing a fee increase in this rule revision.
State fiscal effect
None.
Local government fiscal effect
None.
Private sector fiscal effect
Increase costs. Will not have significant economic impact on a substantial number of businesses.
Long-range fiscal implications
None known.
Text of Proposed Rule
SECTION 1. DHS 157.03 (5), (6), (32m) (a), (33) (a), and (50) (intro.) and (a) are amended to read:
DHS 157.03 (5) "Accelerator" means any machine capable of accelerating electrons, protons, deuterons or other charged particles in a vacuum and of discharging the resultant particle or other radiation into a medium at energies usually in excess of one MeV.
Particle accelerator is considered an equivalent term.
(6)
"Accelerator-produced
radioactive
material" means any material made radioactive by an accelerator.
(50)
"Byproduct material" means
either
any
of the following:
(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or
utilizing
using
special nuclear material.
SECTION 2. DHS 157.03 (50) (c) to (e), (75r), and (103r) are created to read:
DHS 157.03 (50)
(c) Any discrete source of radium-226 that has been produced, extracted or converted after extraction, for use for a commercial, medical or research activity.
(d) Any material that has been made radioactive by use of a particle accelerator, and is produced , extracted, or converted after extraction, for use for a commercial, medical or research activity.
(e) Any discrete source of naturally occurring radioactive material, other than source material, that the NRC, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security, and is extracted or converted after extraction for use in a commercial, medical or research activity.
(75r)
"Consortium" means an association of medical use licensees and a positron emission tomography (PET) radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility must be located at an educational institution, a federal facility or a medical facility.
(103r)
"
Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.
SECTION 3. DHS 157.03 (191) and (200) are amended to read:
DHS 157.03 (191)
"Licensed practitioner" means a chiropractor, dentist, physician, podiatrist,
physician's assistant, nurse practitioner or radiologist's assistant
licensed in the state of Wisconsin.
(200)
"Low specific activity - III" or "LSA-III material" means solids, such as consolidated wastes or activated materials, excluding powders,
that satisfy the requirements of
10 CFR 71.77
, for which all of the following apply:
SECTION 4. DHS 150.03 (221m) is created to read:
DHS 150.03 (221m) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in Appendix T. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.
SECTION 5. DHS 157.03 (222), (374) (a), (c) and (d), (382), (388), (402m), (407), and (413) are amended to read:
(222)
"NARM" means any naturally occurring or accelerator-produced radioactive material.
It does not include byproduct, source or special nuclear material.
(374)
(a) For capacitor energy storage equipment, peak tube potential in
kV
kilovoltage
and quantity of charge in
mAs
millamperage-seconds (mAs)
.
(c) For CT
x-ray systems
equipment
designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in
mA
millamperes
(mA), x-ray pulse width in milliseconds, and the number of x-ray pulses per scan; or the product of tube current, x-ray pulse width, and the number of x-ray pulses per scan expressed as mAs.
(d) For CT x-ray
systems
equipment
not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent.
(382)
"Therapeutic radiation machine" means x-ray, gamma ray or electron-producing equipment designed and used for external beam
or internal
radiation therapy.
(388)
"Total effective dose equivalent" or "TEDE" means the sum of the
deep
effective
dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.
(402m)
"Unirradiated uranium" means uranium containing not more than 2 X 10
3
Bq of plutonium per gram of uranium-235, not more than 9 X 10
6
Bq of fission products per gram of uranium- 235, and not more than 5 X
10
-3
g of uranium-236 per gram of uranium-235.
(407)
"Useful beam" means the radiation
emanating from
which passes through
the tube housing port
or
the radiation head and passing through
and
the aperture of the beam-limiting device when the exposure
controls are in a mode to cause the system to produce radiation
switch or timer is activated.
(413)
"Waste" means those
materials having a low level of radioactivity containing that are acceptable for disposal in a land disposal facility and are not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in
42
USC 2011
low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in DHS 157.03 (50) (b) to (e)
.
SECTION 6. DHS 157.03 (430m) is created to read:
DHS 157.03 (430m)"X-ray control" means a device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors on an x-ray exposure.
SECTION 7. DHS 157.05 (5) title is created to read:
DHS 157.05
(5)
PHYSICAL CONTROLS.
SECTION 8. DHS 157.09 (2) (a) 2., (c) 2. intro., 3., and (d) title are amended to read:
DHS 157.09 Exemptions. (2)
EXEMPTIONS OF RADIOACTIVE MATERIAL OTHER THAN SOURCE MATERIAL. (a) 2. A manufacturer, processor or producer of a product or material is exempt from the requirements of subch. II if they transfer radioactive material contained in a product or material in concentrations not in excess of those in Appendix A and introduced into the product or material by a licensee holding a specific license issued by the department, the NRC or another agreement state expressly authorizing such introduction.
This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.
(c) 2. Timepieces, hands or dials containing promethium-147
or radium-226
, when measured through 50 milligrams per square centimeter of absorber, not exceeding the following radiation dose rate:
3. Timepieces containing up to 37 kBq (1.0 microcurie) of radium-226 per timepiece acquired prior to the effective date of
August 1, 2002
the effective date of this section
…
.[legislative reference bureau inserts date].
(d) (title)
Self-luminous products containing tritium, krypton-85,
or
promethium-147
or radium-226
.
SECTION 9. DHS 157.09 (2) (d) 4. is repealed.
SECTION 10. DHS 157.09 (2) (f) and (g) 3. are amended to read:
DHS 157.09 (2) (f)
Resins containing scandium-46 and designed for sand-consolidation in oil wells.
A person is exempt from this subchapter to the extent that the person receives, possesses, uses, transfers, owns or acquires synthetic plastic resins containing scandium-46 which are designed for sand consolidation in oil wells. These resins shall have been manufactured or initially transferred for sale or distribution under a specific license issued by the NRC, or shall have been manufactured under the specifications contained in a specific license issued by the department or any agreement state to the manufacturer of the resins
under licensing requirements equivalent to those in 10 CFR 32.16 and 32.17
. This exemption does not authorize the manufacture
or initial transfer for sale or distribution
of any resins containing scandium-46.
(g) 3. Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license according to
s. DHS 157.13 (4) (i)
10 CFR 32.21
.
SECTION 11. DHS 157.11 (2) (b) 3. b., c., g. and h. are amended to read:
DHS 157.11 (2)
(b) 3. b. Ensure that the device is tested for leakage of radioactive material and proper operation of the "on-off" mechanism and indicator, if any, at no longer than 6-month intervals or at such other intervals as are specified in the label, except for devices containing only
krypton,
tritium, not more than 3.7 MBq (100 microcuries) of other beta and gamma-emitting material, or 0.37 MBq (10 microcuries) of alpha-emitting material, and devices held in storage in the original shipping container prior to the initial installation.
Devices containing only krypton need not be tested for leakage of radioactive material.
c. Ensure that
the tests required by this subd. par. b. and
other testing, installation, servicing and removal from installation involving the radioactive material, its shielding or containment, are performed under the instructions provided by the labels, or by a person holding an applicable specific license from the department, the NRC, an agreement state or a licensing state to perform such activities.
g. Except as provided in subd.
3.h.
pars. h. and j.
, transfer or dispose of the device containing radioactive material only by transfer to a specific licensee of the department, the NRC, an agreement state or a licensing state whose specific license authorizes that person to receive the device and within 30 calendar days after transfer of a device to a specific licensee
or export of the device
shall furnish to the department a written report containing identification of the device by manufacturer's
or initial transferer's
name
and
,
model
and serial
number
and
, the name
and
,
address
and license number
of the person receiving the device
, and the date of the transfer
.
No report is required if the device is transferred to the specific licensee to obtain a replacement device
.
h. Transfer the device to another general licensee only where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general licensee, or where the device remains in use at a particular location. In the latter case, the transferor shall give the transferee a copy of sub. (2) (b) and any safety documents identified in the label on the device and within 30 calendar days of the transfer. The licensee shall report to the department the manufacturer's name
and
,
model
and serial
number of device transferred, the name and address of the transferee, and the name
, phone number
and position of an individual who may constitute a point of contact between the department and the transferee.
SECTION 12. DHS 157.11 (2) (b) 3. j. to m. are created to read:
DHS 157.11
(2)
(b) 3. j. Not export the device containing byproduct material except as allowed under
10 CFR Part 110
.
k. Respond to written requests from the department to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within the same time period, request in writing a longer time period and provide written justification why it cannot comply.
L. Appoint an individual responsible for having knowledge of the appropriate requirements of this chapter and the authority for taking required actions to comply with these requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with the appropriate requirements of this chapter. This appointment does not relieve the general licensee of any of its responsibility under this chapter.
m. May not hold devices that are not in use for longer than 2 years. If devices with shutters are not being used, the shutter shall be locked in the closed position. The testing required under this subd. par. b. need not be performed during the period of storage only. When devices are put back into service or transferred to another person, and have not been tested within the required time interval, they shall be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.
SECTION 13. DHS 157.11 (2) (b) 4. is amended to read:
DHS 157.11
(2
)
(b) 4. The general license under this paragraph does not authorize the manufacture
or import
of devices containing radioactive material.
SECTION 14. DHS 157.11 (2) (h) is created to read:
DHS 157.11 (2) (h) G
eneral license relating to certain items and self-luminous products containing radium-226.
1. A general license is issued to own, receive, acquire, possess, use or transfer radium-226 contained in the following products:
a. Antiquities originally intended for use by the general public that were manufactured in the 19
th
and 20
th
centuries, such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts and healing pads.
b. Intact timepieces containing greater than 37 kBq (1 microcurie) of radium-226, nonintact timepieces, and timepiece dials and hands no longer installed in timepieces.
c. Self-luminous items installed in air, marine or land vehicles.
d. All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.
e. Small radium sources, such as discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations, electron tubes, lightning rods, ionization sources or static eliminators, containing no more than 37 kBq (1 microcurie) of radium 226.
2. The general license in this paragraph is exempt from the requirements of subchs. III and X with the exception of ss.
DHS 157.30 (1)
,
157.32 (1)
and
(2)
. This exemption does not apply to any person specifically licensed under this chapter.
3. A person who owns, receives, acquires, acquires, possesses,uses or transfers radium-226 under the general license in subd. 1. shall do all the following:
a. Report to the department under DHS 157.32 any stolen, lost or missing radioactive material.
b. Not abandon the product containing radium-226. The product, and any radioactive material from the product, shall be disposed of according to the requirements of DHS 157.30 (8), by transfer to a person authorized under a specific license to receive the radium-226, or as approved by the department.
c. Not export products containing radium-226 except under
10 CFR 110
.
d. Respond to written requests from the department to provide information relating to the general license within 30 calendar days of the date of the request,or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within the same time period, request in writing a longer time period and provide written justification why it cannot comply.
4. The general license in subd. 1. does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.
SECTION 15. DHS 157.12 (1) is renumbered DHS 157.12 (1) (a) and as renumbered is amended to read:
DHS 157.12
(1) REGISTRATION REQUIREMENT. (a) No person may possess, receive, use, own or transfer a device purchased under a general license that contains at least 370 MBq (10 millicuries) of cesium-137, 3.7 MBq (0.1 millicurie) of strontium-90, 37 MBq (1 millicurie) of cobalt-60,
3.7 MBq (0.1 millicurie) of radium-226
or 37 MBq (1 millicurie) of americium- 241 or any other transuranic unless that person registers annually with the department and pays a fee as prescribed in sub.(6).
Each address for a location of use as described in sub. (3) (d) represents a separate general licensee and requires a separate registration.
SECTION 16. DHS 157.12 (1) (b) is created to read:
DHS 157.12 (1) (b) A person in possession of devices that meet the criteria for registration under par. (a) shall notify the department of bankruptcy as specified in s.
DHS 157.13 (10) (e)
and
(f)
.
SECTION 17. DHS 157.13 (1) (j) is created to read:
DHS 157.13 (1) (j) 1. A request for authorization for the production of PET radionuclides or evidence of an existing license issued by the department, NRC or an agreement state under this chapter or equivalent regulations for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.
2. Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in s.
DHS 157.13 (4) (i)
.
3. Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in s.
DHS 157.68
.
4. Information identified in s.
DHS 157.13 (4) (i) 3.
on the PET drugs to be noncommercially transferred to members of a consortium.
SECTION 18. DHS 157.13 (4) (g) 2. b., d. and e., and (i) (title), (intro.) and 2. a. are amended to read:
DHS 157.13
(4) (g) 2. b. Cobalt-57 in units not exceeding 370
MBq
kBq
(10 microcuries) each.
d. Iodine-125 in units not exceeding 370
MBq
kBq
(10 microcuries) each.
e. Mock Iodine-125 in units not exceeding 1.85
MBq
kBq
(0.05 microcurie) of iodine-129 and 185
MBq
Bq
(0.005 microcurie) of americium-241 each.
(i)
Manufacture, preparation, or transfer for commercial distribution
or noncommercial transfer to medical use licensees in a consortium
of radioactive drugs containing radioactive material for medical use under subchapter VI.
The department shall approve an application for a specific license to manufacture, prepare, or transfer for commercial distribution
or noncommercial transfer to medical use licensees in a consortium
drugs containing radioactive material for use by a person authorized under subchapter VI if all the following conditions are satisfied:
2. a. Registered or licensed with the FDA as
a drug manufacturer
the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding or processing of a drug under 21 CFR 207.20 (a)
.
SECTION 19. DHS 157.13 (4) (i) 2. e. is created to read:
DHS 157.13 (4)
(i) 2. e. Registered with a state agency as a positron emission tomography (PET) drug production facility.
SECTION 20. DHS 157.13 (4) (i) 4. a. and b. and 6. a. are amended to read:
DHS 157.13 (4) (i) 4. a. A label is affixed to each transport radiation shield, whether the shield is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution
or noncommercial transfer to medical use licensees in a consortium
. The label shall include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half life greater than 100 days, the time may be omitted.
b. A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution
or noncommercial transfer to medical use licensees in a consortium
. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container may be correlated with the information on the transport radiation shield label.
6. a. Possess and use instrumentation to measure the radioactivity of the drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha, beta, or photon-emitting drugs prior to transfer for commercial distribution
or noncommercial transfer to medical use licensees in a consortium
.
SECTION 21. DHS 157.13 (4) (i) 4. d. is created to read:
DHS 157.13 (4) (i) 4. d. Measure the concentration of radionuclide contaminant in the first eluate after receipt of a molybdenum-99/technetium-99m or strontium-82/rubidium-82 generator, test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, according to s.
DHS 157.63 (3)
, and retain a record of each measurement under s.
DHS 157.71 (14)
.
SECTION 22. DHS 157.13 (4) (j) (intro.) is amended to read:
DHS 157.13
(4) (j)
Manufacture and distribution of sources or devices containing radioactive material for medical use.
The department shall approve an application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed under subch. VI for use as a calibration,
transmission
or reference source or for the uses listed in ss.
DHS 157.65 (1)
,
157.66 (1)
and
,
157.67 (1)
and 157.70
if all of the following conditions are satisfied:
SECTION 23. DHS 157.13 (17) (b) 4. Note and (c) 2. Note and (19) are created to read:
DHS 157.13 (17) (b) 4. Note: Submit report to the Department via telephone at (608) 267-4797 or via facsimile at (608) 267-3695.
(c) 2. Note: Submit written reports to the Department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659.
(19) SERIALIZATION
OF NATIONALLY TRACKED SOURCES. A licensee who manufactures a nationally tracked source shall assign a unique serial number to each nationally tracked source. Serial numbers shall be composed only of alpha-numeric characters.
SECTION 24. DHS 157.22 (1) (c) 1. is amended to read:
DHS 157.22 Occupational dose limits. (1) (c) 1.
When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent shall be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a method approved by the department.
The assigned deep-dose equivalent shall be for the part of the body receiving the highest exposure. The assigned shallow- dose equivalent shall be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest exposure. The deep-dose equivalent, 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.
SECTION 25. DHS 157.25 (2) (a) 6. is repealed.
SECTION 26. DHS 157.29 (6) (e) 1. is amended to read:
DHS 157.29 (6) (e) 1. Removable radioactive surface contamination exceeds the limits of s.
DHS 157.94 (1) (h)
DHS 157.94 (1) (i)
.
SECTION 27. DHS 157.30 (1) (a) 4. and (6) (b) are amended to read:
DHS 157.30 (1)
(a) 4. Dispose of as authorized under
sub
subs
. (2), (3), (4)
or
,
(5)
or (8)
.
(6)
TRANSFER FOR DISPOSAL AND MANIFESTS. (b) Any licensee shipping radioactive waste
or byproduct material as defined in s.
DHS 157.03 (50) (c)
to
(e)
intended for ultimate disposal at a licensed land disposal facility shall document the information required in Appendix G, Section I and transfer this recorded information to the intended consignee in accordance with the requirements of Appendix G.
SECTION 28. DHS 157.30 (8) is created to read:
DHS 157.30 (8) DISPOSAL OF CERTAIN BYPRODUCT MATERIAL. (a) Licensed byproduct material as defined in DHS 157.03 (50) (c) to (e) may be disposed of under
10 CFR 61
or equivalent agreement state regulations, even though it is not defined as low level radioactive waste. Any licensed byproduct material being disposed of at a facility, or transferred for ultimate disposal at a facility licensed by the NRC under
10 CFR 61
or an agreement state with equivalent regulations shall meet the requirements of
10 CFR 20.2006
.
(b) A licensee may dispose of byproduct material as defined in s.
DHS 157.03 (50) (c)
to
(e)
at a disposal facility authorized to dispose of such material under federal or state solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005.
SECTION 29. DHS 157.32 (9) is created to read:
DHS 157.32 (9) REPORTS OF TRANSACTIONS INVOLVING NATIONALLY TRACKED SOURCES. A licensee who manufactures, transfers, receives, disassembles or disposes of a nationally tracked source shall submit a report to the Nuclear Regulatory Commission that complies with the requirements of
10 CFR 20.2207
.
SECTION 30. DHS 157.42 (1) (a) and (b) are amended to read:
DHS 157.42 (1) (a) An entrance control of the type described in s.
DHS 157.26 (1) (a) 1.
that causes the radiation level upon entry into the area to be reduced.
Entrance control devices that reduce the radiation level upon entry shall be tested monthly.
(b) Both conspicuous visible and audible warning signals to warn of the presence of radiation. The visible signal shall be actuated by radiation whenever the source is exposed or the machine is energized. The audible signal shall be actuated when an attempt is made to enter the installation while the source is exposed or the machine is energized. The alarm system shall be tested for proper operation with a radiation source each day before the installation is used for radiographic operations. The test shall include a check of both the visible and audible signals.
Entrance control devices that reduce the radiation level upon entry shall be tested monthly.
SECTION 31. DHS 157.53 (1) (a) 1. is amended to read:
DHS 157.53 Requirements for personnel safety. (1) (a) 1. Completed
a course recognized by the department, the NRC, another agreement state or a licensing state
training
incorporating the subjects outlined in Appendix J and demonstrated an understanding of the subject matter by successful completion of a written examination.
SECTION 32. DHS 157.61 (10) (a) is amended to read:
DHS 157.61 (10) (a) An individual identified as a radiation safety officer, a teletherapy or
authorized
medical physicist,
an
authorized medical physicist
or a nuclear pharmacist on a department, NRC or another agreement state license, the permit issued by a licensee of broad scope or the permit issued by an NRC master material licensee
before October 24, 2002
need not comply with the training requirements of subs. (7) to (9), respectively.
SECTION 33. DHS 157.61 (10) (b) is renumbered DHS 157.61 (10) (c).
SECTION 34. DHS 157.61 (10) (b) is created to read:
DHS 157.61 (10) (b) An individual identified as a Radiation Safety Officer, an authorized medical physicist, or an authorized nuclear pharmacist on a department, NRC or another agreement state license, the permit issued by a licensee of broad scope or the permit issued by NRC master material licensee between October 24, 2002 and April 29, 2005 need not comply with the training requirements of ss.
DHS 157.61 (7)
,
(8)
or
(9)
.
SECTION 35. DHS 157.62 (1) (b) is amended to read:
DHS 157.62 Technical requirements. (1) (b) A licensee shall calibrate the instrumentation required in par. (a) according to
nationally recognized standards or
the manufacturer's instructions.
SECTION 36. DHS 157.62 (3) (b) 2. c. is created to read:
DHS 157.62 (3) (b) 2. c. A PET radioactive drug producer licensed under s.
DHS 157.13 (1) (j)
or by NRC or another agreement state.
SECTION 37. DHS 157.62 (3) (c) 3. is amended to read:
DHS 157.62 (3) (c) 3. A combination of volumetric measurements and mathematical calculations, based on the measurement made by a manufacturer or preparer licensed under s.
DHS 157.13 (4) (i)
,
a PET radioactive drug producer licensed under s.
DHS 157.13 (1) (j)
,
or equivalent NRC or other agreement state requirements.
SECTION 38. DHS 157.63 (1) (a) is renumbered DHS 157.63 (1) (a) (intro.) and as renumbered is amended to read:
DHS 157.63 (1) (a) Is obtained from
a manufacturer or preparer licensed under s. DHS 157.13 (4) (i) or equivalent NRC or other agreement state requirements.
either of the following:
SECTION 39. DHS 157.63 (1) (a) 1. and 2. are created to read:
DHS 157.63 (1) (a) 1. A manufacturer or preparer licensed under s.
DHS 157.13 (4) (i)
, or equivalent NRC or other agreement state requirements.
2. A PET radioactive drug producer licensed under s.
DHS 157.13 (1) (j)
, or equivalent NRC or other agreement state requirements.
SECTION 40. DHS 157.63 (1) (b) (intro.) is amended to read:
DHS 157.63 (1) (b) (intro.) Is prepared by
, excluding production of PET radionuclides,
any of the following:
SECTION 41. DHS 157.63 (2) (a) is renumbered DHS 157.63 (2) (a) (intro.) and as renumbered is amended to read:
DHS 157.63 (2) (a) Is obtained from
a manufacturer or preparer licensed under s. DHS 157.13 (4) (i) or equivalent NRC or agreement state requirements.
either of the following:
SECTION 42. DHS 157.63 (2) (a) 1. and 2. are created to read:
DHS 157.63 (2) (a)1. A manufacturer or preparer licensed under s.
DHS 157.13 (4) (i)
, or equivalent NRC or other agreement state requirements.
2. A PET radioactive drug producer licensed under s.
DHS 157.13 (1) (j)
, or equivalent NRC or other agreement state requirements.
SECTION 43. DHS 157.63 (2) (b) intro., (3) (a) 1. to 3., (5) (a) 1. and (6) (a) are amended to read:
DHS 157.63 (2)
(b) (intro.) Is prepared by
, excluding production of PET radionuclides,
any of the following:
(3)
(a) 1. 0.15 kilobecquerel
(0.15 microcurie)
of molybdenum-99 per megabecquerel of technetium-99m
(0.15 microcure of molybdenum-99 per 1 millicure of technetium 99m)
.
2. 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection
(0.02 microcurie of strontium-82 per 1 millicurie of rubidium-82 chloride injection)
.
3. 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection
(0.02 microcurie of strontium-85 per 1 millicurie of rubidium-82 chloride injection)
.
(5)
(a) 1. Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for
uptake, dilution, and excretion
imaging and localization
studies that includes the topics listed in par. (c) 1. and 2.
(6)
WRITTEN ATTESTATION. (a)
Unsealed radioactive material for uptake, dilution, and excretion studies for which a written directive is not required.
A licensee shall require an authorized user of unsealed radioactive material for the uses authorized under sub. (1) to have obtained written attestation, signed by a preceptor authorized user who meets the requirements of subs. (4)
and
or
(5), s.
DHS 157.64 (4)
, or equivalent agreement state requirements, that the individual has satisfactorily completed the requirements of sub. (4) (a) 1. or (c) and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under sub. (1).
SECTION 44. DHS 157.64 (1) (a), (b) (intro.) and (5) (b) are amended to read:
DHS 157.64 (1) (a) Obtained from a manufacturer or preparer licensed under s.
DHS 157.13 (4) (i)
, a PET radioactive drug producer licensed under s.
DHS 157.13 (1) (j)
,
or equivalent NRC or other agreement state requirements.
(b)
Prepared
Excluding production of PET radionuclides, is prepared
by any of the following:
(5) (b) Is an authorized user under sub. (4) (a)
and
or
(b) for specified uses of I-131 listed in subs. (4) (b) 2. g., and (6), or equivalent agreement state requirements.
SECTION 45. DHS 157.67 (8) (b) 1. is amended to read:
DHS 157.67 (8) (b) 1. The output within 5%
of the source strength
.
SECTION 46. DHS 157.68 (1) (intro.) and (2) (e) are amended to read:
DHS 157.68 Radioactive drugs for medical use. (1) PREPARATION. A licensee authorized to manufacture, prepare or transfer for commercial distribution
or noncommercial transfer to medical use licensees in a consortium
radioactive drugs shall ensure that any individual preparing the drugs is one of the following:
(2) (e) The state pharmacist licensure, no later than 30 days after the date that the licensee allows
, under sub. (1) (c)1. and 2.,
the individual to work as an authorized nuclear pharmacist.
SECTION 47. DHS 157.72 (1) (c) Note and (d) 3. Note are created to read:
DHS 157.72 (1) (c) Note:
Submit report to the Department via telephone at (608) 267-4797 or via facsimile at (608) 267-3695.
(d) 3. Note:
Submit written reports to the Department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659.
SECTION 48. DHS 157.74 (2) (L) is created to read:
DHS 157.74 (2) (L) A registrant that uses two or more therapy devices for human use shall establish a radiation safety committee consisting of at least three members to oversee the use of all therapeutic radiation machines. The committee shall include an operator authorized by the registrant, a representative of the institution's management, and the radiation safety officer. If the institution has a radiation safety committee established under s.
DHS 157.61(1)(e)
, this committee may be designated to oversee the use of all therapeutic radiation machines, if an operator authorized by the registrant is appointed to this committee.
SECTION 49. DHS 157.74 (3) (title) is amended to read:
DHS 157.74 (3)
(title)
X-RAY
FILM
IMAGE
PROCESSING EQUIPMENT AND PROCESSING PROCEDURES.
SECTION 50. DHS 157.74 (3) (a) title is created to read:
DHS 157.74 (3)
(a)
Film.
SECTION 51. DHS 157.74 (3) (a) to (d) are renumbered DHS 157.74 (3) (a) 1., 2., 3. and 4.
SECTION 52. DHS 157.74 (3) (b) is created to read:
DHS 157.74 (3) (b)
Digital Imaging Systems.
1. Each installation using a digital radiographic x-ray system for human diagnosis or screening shall have available suitable equipment for handling and processing the radiographic digital image according to the manufacturer's instructions.
2. Quality control and maintenance procedures shall be performed on a regular schedule according to the device manufacturer's recommendations. If analysis shows that the image quality has declined, corrective action shall be taken prior to performing patient examinations.
SECTION 53. DHS 157.76 (11), (12) and Note are created to read:
DHS 157.76 (11) EQUIPMENT OPERATIONS. (a) The facility shall ensure that only a licensed practitioner or a radiologic technologist who is trained in the safe use of fluoroscopic x-ray systems shall be allowed to operate these systems. All fluoroscopic x-ray images shall be viewed, directly or indirectly, and interpreted by a licensed practitioner.
(b). The use of fluoroscopic x-ray systems by radiologic technologists shall be performed under the supervision of a licensed practitioner for the purpose of localization to obtain images for diagnostic purposes.
(c) Radiologic technology students may not operate fluoroscopic x-ray systems except under the direct supervision of a licensed practitioner or radiologic technologist.
(d) Fluoroscopic x-ray systems may not be used as a positioning tool for general purpose radiographic examinations.
(e) The registrant shall require the operator of a fluoroscopic x-ray system to meet either of the following requirements:
1. Is certified by the American Board of Radiology or board eligible.
2. Has completed training to include but not limited to the following:
a. Principles and operation of the fluoroscopic x-ray system.
b. Biological effects of x-ray.
c. Principles of radiation protection.
d. Fluoroscopic outputs.
e. High level control options.
f. Dose reduction techniques for fluoroscopic x-ray systems.
g. Applicable state and federal regulations.
(12)
AIR KERMA MEASUREMENTS.
Annual measurements of both typical and maximum air kerma shall be made by a medical physicist or a person approved by a medical physicist.
Note: Materials should be placed in the useful beam to protect the imaging system when conducting these periodic measurements. Air kerma measurements do not include backscatter.
SECTION 54. DHS 157.77 (2) (g) is amended to read:
DHS 157.77 (2) (g)
Exposure control location.
The x-ray exposure control shall be placed so that the operator may view the patient while making any exposure and at least
3 feet
1 meter (3.3 feet)
from the end of the protective barrier.
SECTION 55. DHS 157.79 (2) (c) is amended to read:
DHS 157.79 (2) (c) A
deadman
dead-man
type of exposure switch shall be provided with an electrical cord of sufficient length so that the operator or the assistant, may stand out of the useful beam and at least 2 meters (6.5 feet) from the table during all x-ray exposures. A foot operated exposure switch may be used and this switch may be integrated into the table base or the foot switch may be on a 2 meter (6.5 feet) cord.
SECTION 56. DHS 157.80 (2) (a) is renumbered DHS 157.80 (2) (a) 1. and 3. and amended to read:
DHS 157.80 (2) OPERATING PROCEDURES. (a)
1.
A CT x-ray system
for human use
may only be operated for diagnostic procedures by an American registry of radiologic technologists certified person who has been specifically trained in its operation.
3. Combination systems which are designated as PET/CT shall be operated by a person qualified by training in the safe use of radioactive materials and who meets the training requirements of Appendix L.
SECTION 57. DHS 157.80 (2) (a) 2. is created to read:
DHS 157.80 (2) (a)
2. A CT x-ray system for veterinary use may only be operated for diagnostic procedures by a person who is certified by the American registry of radiological technologists or has completed training equivalent to the requirements of Appendix L and has been specifically trained in its operation.
SECTION 58. DHS 157.81 (1) and (2) are amended to read:
DHS 157.81 Shielding plan review. (1) PLAN REVIEW AND APPROVAL. Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations, utilizing ionizing radiation machines
, including dental CT and dental cephalometric machines,
shall be submitted to the department for review and approval.
(2) EXEMPTIONS. Dental
intraoral and panoramic,
mammography, and bone density devices are exempt from this section.
SECTION 59. DHS 157.81 (3) (c) 7. is created to read:
DHS 157.81 (3) (c) 7. The x-ray exposure control shall be located within the shielded area and at least 1 meter (3.3 feet) from the open end of the protective barrier, excluding mammography units.
SECTION 60. DHS 157.82 (2) (c) and (5) (c) are created to read:
DHS 157.82 (2) (c) A registrant for electronic brachytherapy shall require the authorized user to complete device specific instruction from the manufacturer or individual trained by the manufacturer, and training on procedures required by s.
DHS 157.85(16)(g) 4.
and
5.
(5) (c) A person who will be operating an electronic brachytherapy unit shall complete device specific instruction from the manufacturer or individual trained by the manufacturer, and training on procedures required by s.
DHS 157.85 (16) (g) 4.
and
5.
SECTION 61. DHS 157.82 (6) is amended to read:
DHS 157.82 (6) SAFETY PROCEDURES. Written safety procedures and rules, including any restrictions required for the safe operation of the particular therapeutic radiation machine, shall be developed by a medical physicist and shall be available in the control area of a therapeutic radiation machine. The operator shall be able to demonstrate familiarity with these rules.
Operators, authorized users and medical physicists for electronic brachytherapy shall participate in drills of the emergency procedures, required by s.
DHS 157.85(16)(g) 5.
, initially and at least annually thereafter
.
SECTION 62. DHS 157.83 (1) (a) and (c) are amended to read:
DHS 157.83 (1) (a) Prior to administration, a written directive is prepared for any external beam radiation therapy dose
or electronic brachytherapy dose
. A written revision to an existing written directive may be made
prior to beginning treatment, or prior to delivery of a fractional dose,
provided that the revision is dated and signed by an authorized user
prior to administration of the external beam radiation therapy dose, or the
next external beam radiation therapy fractional dose
. If, because of the patient's condition, a delay to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive shall be acceptable provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by an authorized user within 24 hours of the oral revision.
(c) External beam radiation therapy
or electronic brachytherapy
final plans of treatment and related calculations are according to the respective written directives.
SECTION 63. DHS 157.85 (13) (em) is created to read:
DHS 157.85 (13) (em) Full calibration for electronic brachytherapy units shall include all of the following:
1. Timer accuracy and linearity over the typical range of use.
2. Proper operation of back-up exposure control devices.
3. The output within 2 % of the expected value, if applicable, or determination of the output if there is no expected value.
4. Evaluation that the relative dose distribution about the source is within 5 % of the expected value.
5. Source position accuracy to within 1 millimeter within the applicator.
6. Determination of the proper length of source transfer tubes and applicators.
7. Determination of the operability of the source transfer tubes, applicators and transfer tube-applicator interfaces.
SECTION 64. DHS 157.85 (14) (e) is amended to read:
DHS 157.85 (14) (e) A registrant shall have the medical physicist review and sign the results of each radiation output quality control check
and notify the registrant of results
within 10 working days of the date that the check was performed.
SECTION 65. DHS 157.85 (14) (fm) is created to read:.
DHS 157.85 (14) (fm) If the results of the quality control checks indicate malfunction of any system, the registrant shall prevent clinical use of the system until repaired.
SECTION 66. DHS 157.85 (14) (g) 4. is amended to read:
DHS 157.85 (14) (g) 4. Viewing
and intercom
systems
, if applicable
.
SECTION 67. DHS 157.85 (14) (g) 6. and (gm) are created to read:
DHS 157.85 (14) (g) 6. If applicable, the integrity of all cables, catheters or parts of the device that carry high voltages.
(gm) Daily quality control checks for electronic brachytherapy shall include all the following:
1. The output of the x-ray source falls within 3 % of expected values, which includes output as a function of time or output as a function of setting on a monitor chamber.
2. Verification of the consistency of the dose distribution to within 3 % of that found during calibration.
3. Validation of the operation of positioning methods to assure that the treatment dose exposes the intended location to within 1 mm.
4. Inspection of all treatment components on the day of use.
SECTION 68. DHS 157.85 (16) (g) is created to read:
DHS 157.85 (16) (g) A registrant for electronic brachytherapy shall do all of the following:
1. Ensure the electronic brachytherapy unit is inoperable, either by hardware or password, when unattended by qualified staff or service personnel.
2. Secure the unit, console, console keys and the treatment room when unattended or not in use.
3. Prevent dual operation of more than one radiation producing device in a treatment room, if applicable.
4. Create a written procedure for safe operation of each device.
5. Develop, implement and maintain written procedures for responding to an abnormal situation. The procedure shall include all the following:
a. Instructions for responding to equipment failures and the names of the persons responsible for implementing corrective actions.
b. The names and telephone numbers of the licensed practitioner, the medical physicist, the radiation safety officer and the manufacturer to be contacted if the unit or console operates abnormally.
6. Maintain a copy of the procedures required by subd. 4. and 5. at the unit console.
7. Ensure all of the following is done during treatment:
a. Only individuals approved by the authorized user, radiation safety officer or medical physicist may be present in the treatment room.
b. Protective shielding shall be available for persons in the treatment room.
c. A radiation survey is performed when the unit and/or shielding is portable to verify proper shielding placement immediately upon initiation of treatment.
d. A medical physicist and operator shall be physically present during the initiation and course of patient treatment.
e. A medical physicist or operator shall monitor the position of all persons in the treatment room to prevent unshielded exposure.
f. A medical physicist or operator shall monitor all entrances to prevent entering individuals from unshielded exposure.
g. Only mechanical supporting or restraining devices may be used to hold a patient in position, when applicable.
SECTION 69. DHS 157.88 (3) (a) (intro.) is amended to read:
DHS 157.88 (3) (intro.) NOTIFICATIONS AND REPORTS TO INDIVIDUALS. (a)
Radiation exposure reports.
Every 12 months, a licensee or registrant shall provide a written report of radiation exposure to each employee who is required to be monitored for radiation exposure under s.
DHS 157.25 (2)
if the employee's annual dose exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or tissue
. The report shall include all of the following:
SECTION 70. DHS 157.92 (2) (c) 5. (intro.) and (3) (a) (intro.)and (b) are amended to read:
DHS 157.92 (2) (c) 5. (intro.) Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of two percent by
weight
mass
, provided that all the following conditions apply:
(3)
TRANSPORT OF LICENSED MATERIAL. (a) A licensee who transports licensed material outside the site of usage, as specified in the department license, or on public highways, or who delivers licensed material to a carrier for transport, shall
comply with the applicable requirements of the DOT regulations in
49 CFR 107
,
171
to
180
, and
390
to
397
, appropriate to the mode of transport and
do all the following:
(b) If the regulations of the U.S. department of transportation are not applicable to a shipment of licensed material, a licensee shall comply with the requirements of 49 CFR
170 to 189
107, 171 to 180, and 390 to 397
, appropriate to the mode of transport as if the shipment was subject to the regulations. A request for modification, waiver or exemption from these requirements and any notification referred to in these requirements shall be submitted in writing to the department.
SECTION 71. APPENDIX E, List of Elements (page 439) is amended to read:
List of Elements
Atomic
Name
Symbol
Number
Actinium
Ac
89
Aluminum
A
13
Americium
Am
95
Antimony
Sb
51
Argon
Ar
18
Arsenic
As
33
Astatine
At
85
Barium
Ba
56
Berkelium
Bk
97
Beryllium
Be
4
Bismuth
Bi
83
Bromine
Br
35
Cadmium
Cd
48
Calcium
Ca
20
Californium
Cf
98
Carbon
C
6
Cerium
Ce
58
Cesium
Cs
55
Chlorine
Cl
17
Chromium
Cr
24
Cobalt
Co
27
Copper
Cu
29
Curium
Cm
96
Dysprosium
Dy
66
Einsteinium
Es
99
Erbium
Er
68
Europium
Eu
63
Fermium
Fm
100
Fluorine
F
9
Francium
Fr
87
Gadolinium
Gd
64
Gallium
Ga
31
Germanium
Ge
32
Gold
Au
79
Hafnium
Hf
72
Holmium
Ho
67
Hydrogen
H
1
Indium
In
49
Iodine
I
53
Iridium
Ir
77
Iron
Fe
26
Krypton
Kr
36
Lanthanum
La
57
Lead
Pb
82
Lutetium
Lu
71
Magnesium
Mg
12
Manganese
Mn
25
Mendelevium
Md
101
|
List of Elements (cont.)
Atomic
Name
Symbol
Number
Mercury
Hg
80
Molybdenum
Mo
42
Neodymium
Nd
60
Neptunium
Np
93
Nickel
Ni
28
Niobium
Nb
41
Nitrogen
N
7
Osmium
Os
76
Oxygen
O
8
Palladium
Pd
46
Phosphorus
P
15
Platinum
Pt
78
Plutonium
Pu
94
Polonium
Po
84
Potassium
K
19
Praseodymium
Pr
59
Promethium
Pm
61
Protactinium
Pa
91
Radium
Ra
88
Radon
Rn
86
Rhenium
Re
75
Rhodium
Rh
45
Rubidium
Rb
37
Ruthenium
Ru
44
Samarium
Sm
62
Scandium
Sc
21
Selenium
Se
34
Silicon
Si
14
Silver
Ag
47
Sodium
Na
11
Strontium
Sr
38
Sulfur
S
16
Tantalum
Ta
73
Technetium
Tc
43
Tellurium
Te
52
Terbium
Tb
65
Thallium
Tl
81
Thorium
Th
90
Thulium
Tm
69
Tin
Sn
50
Titanium
Ti
22
Tungsten
W
74
Uranium
U
92
Vanadium
V
23
Xenon
Xe
54
Ytterbium
Yb
70
Yttrium
Y
39
Zinc
Zn
30
|
SECTION 72. APPENDIX O, s. II is amended to read:
II.
a.
For individual radionuclides whose identities are known, but which are not listed in TABLE VI, the determination of the values of A
1
and A
2
requires department approval, except that the values of A
1
and A
2
in TABLE
VII
VIII
may be used without obtaining department approval.
b. For individual radionuclides whose identities are known, but which are not listed in Table VII, the exempt material activity concentration and exempt consignment activity values contained in Table VIII may be used. Otherwise, the licensee shall obtain prior department approval of the exempt material activity concentration and exempt consignment activity values for radionuclides not listed in Table VII, before shipping the material.
c. The licensee shall submit requests for prior approval, described under paragraphs II(a) and II(b) of this Appendix, in writing to the department.
SECTION 73. APPENDIX O, s. IV, par. (a) is amended to read:
(a) For special form radioactive material, the maximum quantity transported in a Type A package
is as follows
:
where B(i) is the activity of radionuclide i and A
1
(i) is the A
1
value for radionuclide I.
SECTION 74. APPENDIX O, s. IV, par. (b) is renumbered and amended to read:
(b) For normal form radioactive material, the maximum quantity transported in a Type A package
is as follows
:
where B(i) is the activity of radionuclide i
and A
1
(i)
and A
2
(i)
are the A
1
and A
2
is the
values
value
for radionuclide
respectively
i
.
(c) Alternatively,
an
the A
1
value for mixtures of special form material may be determined as follows:
where f(i) is the fraction of activity of nuclide
I
(i)
in the mixture and A
1
(i) is the appropriate A
1
value for nuclide i.
(d)
An
Alternatively the A
2
value for mixtures of normal form material may be determined as follows:
where f(i) is the fraction of activity
of nuclide I
for radionuclide (i)
in the mixture
,
and A
2
(i) is the appropriate A
2
value for
nuclide
radionuclide (i)
.
SECTION 75. APPENDIX O s. IV pars. (e) and (f) are created to read:
(e) The exempt activity concentration for mixtures of nuclides may be determined as follows:
where f(i) is the fraction of activity concentration of radionuclide (i) in the mixture, and [A] is the activity concentration for exempt material containing radionuclide (i).
(f) The activity limit for an exempt consignment for mixtures of radionuclides may be determined as follows:
where f(i) is the fraction of activity of radionuclide (i) in the mixture, and A is the activity limit for exempt consignments for radionuclide (i).
SECTION 76. APPENDIX O, TABLE VII (page 534) is amended to read:
TABLE VII
EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND
EXEMPT CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES
Symbol of radionuclide
|
Element and atomic number
|
Activity concentration for exempt material (Bq/g)
|
Activity concentration for exempt material (Ci/g)
|
Activity limit for exempt consignment (Bq)
|
Activity limit for exempt consignment (Ci)
|
Ac-225 (a)
|
Actinium (89)
|
1.0X10
1
|
2.7X10
-10
|
1.0X10
4
|
2.7X10
-7
|
Ac-227 (a)
|
|
1.0X10
-1
|
2.7X10
-12
|
1.0X10
3
|
2.7X10
-8
|
Ac-228
|
|
1.0X10
1
|
2.7X10
-10
|
1.0X10
6
|
2.7X10
-5
|
Ag-105
|
Silver (47)
|
1.0X10
2
|
2.7X10
-9
|
1.0X10
6
|
2.7X10
-5
|
Ag-108m (a)
|
|
1.0X10
1
|
2.7X10
-10
|
1.0X10
6
|
2.7X10
-5
|
Ag-110m (a)
|
|
1.0X10
1
|
2.7X10
-10
|
1.0X10
6
|
2.7X10
-5
|
Ag-111
|
|
1.0X10
3
|
2.7X10
-8
|
1.0X10
6
|
2.7X10
-5
|
Al-26
|
Aluminum (13)
|
1.0X10
1
|
2.7X10
-10
|
1.0X10
5
|
2.7X10
-6
|
Am-241
|
Americium (95)
|
1.0
|
2.7X10
-11
|
1.0X10
4
|
2.7X10
-7
|
Am-242m (a)
|
|
1.0
|
2.7X10
-11
|
1.0X10
4
|
2.7X10
-7
|
Am-243 (a)
|
|
1.0
|
2.7X10
-11
|
1.0X10
3
|
2.7X10
-8
|
Ar-37
|
Argon (18)
|
1.0X10
6
|
2.7X10
-5
|
1.0X10
8
|
2.7X10
-3
|
Ar-39
|
|
1.0X10
7
|
2.7X10
-4
|
1.0X10
4
|
2.7X10
-7
|
Ar-41
|
|
1.0X10
2
|
2.7X10
-9
|
1.0X10
9
|
2.7X10
-2
|
As-72
|
Arsenic (33)
|
1.0X10
1
|
2.7X10
-10
|
1.0X10
5
|
2.7X10
-6
|
As-73
|
|
1.0X10
3
|
2.7X10
-8
|
1.0X10
7
|
2.7X10
-4
|
As-74
|
|
1.0X10
1
|
2.7X1010
-10
|
1.0X10
6
|
2.7X10
-5
|
As-76
|
|
1.0X10
2
|
2.7X10
-9
|
1.0X10
5
|
2.7X10
-6
|
As-77
|
|
1.0X10
3
|
2.7X10
-8
|
1.0X10
6
|
2.7X10
-5
|
At-211 (a)
|
Astatine (85)
|
1.0X10
3
|
2.7X10
-8
|
1.0X10
7
|
2.7X10
-4
|
Au-193
|
Gold (79)
|
1.0X10
2
|
2.7X10
-9
|
1.0X10
7
|
2.7X10
-4
|
Au-194
|
|
1.0X10
1
|
2.7X10
-10
|
1.0X10
6
|
2.7X10
-5
|
Au-195
|
|
1.0X10
2
|
2.7X10
-9
|
1.0X10
7
|
2.7X10
-4
|
Au-198
|
|
1.0X10
2
|
2.7X10
-9
|
1.0X10
6
|
2.7X10
-5
|
Au-199
|
|
1.0X10
2
|
2.7X10
-9
|
1.0X10
6
|
2.7X10
-5
|
Be-7
|
Beryllium (4)
|
1.0X10
3
|
2.7X10
-8
|
1.0X10
7
|
2.7X10
-4
|
Be-10
|
|
1.0X10
4
|
2.7X10
-7
|
1.0X10
6
|
2.7X10
-5
|
Bi-205
|
Bismuth (83)
|
1.0X10
1
|
2.7X10
-10
|
1.0X10
6
|
2.7X10
-5
|
Bi-206
|
|
1.0X10
1
|
2.7X10
-10
|
1.0X10
5
|
2.7X10
-6
|
Bi-207
|
|
1.0X10
1
|
2.7X10
-10
|
1.0X10
6
|
2.7X10
-5
|
Bi-210
|
|
1.0X10
3
|
2.7X10
-8
|
1.0X10
6
|
2.7X10
-5
|
Bi-210m
|
|
1.0X10
1
|
2.7X10
-10
|
1.0X10
5
|
2.7X10
-6
|
Ba-131 (a)
|
Barium (56)
|
1.0X10
2
|
2.7X10
-9
|
1.0X10
6
|
2.7X10
-5
|
Ba-133
|
|
1.0X10
2
|
2.7X10
-9
|
1.0X10
6
|
2.7X10
-5
|
Ba-133m
|
|
1.0X10
2
|
2.7X10
-9
|
1.0X10
6
|
2.7X10
-5
|
Ba-140 (a)
|
|
1.0X10
1
|
2.7X10
-10
|
1.0X10
5
|
2.7X10
-6
|
SECTION 77. APPENDIX O, TABLE IX (page 547) is amended to read:
Table Ix
Activity-Mass Relationships For Uranium
Uranium
Enrichment* wt % U-235 present
|
Specific Activity
|
|
TBq/g
|
Ci/g
|
0.45
|
1.9 x 10
-8
|
5.4
5.0
|
x 10
-7
0.72
|
2.6 x 10
-8
|
7.1 x 10
-7
|
1
|
2.8 x 10
-8
|
7.6 x 10
-7
|
1.5
|
3.7 x 10
-8
|
1.0 x 10
-6
|
5
|
1.0 x 10
-7
|
2.7 x 10
-6
|
10
|
1.8 x 10
-7
|
4.8 x 10
-6
|
20
|
3.7 x 10
-7
|
1.0 x 10
-5
|
35
|
7.4 x 10
-7
|
2.0 x 10
-5
|
50
|
9.3 x 10
-7
|
2.5 x 10
-5
|
90
|
2.1 x 10
-6
|
5.8 x 10
-5
|
93
|
2.6 x 10
-6
|
7.0 x 10
-5
|
95
|
3.4 x 10
-6
|
9.1 x 10
-5
|
Natural thorium
|
8.1 x 10
-9
|
2.2 x 10
-7
|
SECTION 78. APPENDIX P is amended to read:
Quantities of Radioactive Materials Requiring
Consideration of the Need for a Contingency Plan
for Responding to a Releas
e
|
Radioactive Material
1/
Release Fraction
|
Quantity (GBq)
|
|
Quantity (Ci)
|
Actinium-228 4,000
|
0.001
|
|
148,000
|
Americium-241 2
|
|
0.001
|
74
|
Americium-242 2
|
|
0.001
|
74
|
Americium-243 2
|
|
0.001
|
74
|
Antimony-124
|
0.01
|
148,000
|
4,000
|
Antimony-126
|
0.01
|
222,000
|
6,000
|
Barium-133
|
0.01
|
370,000
|
10,000
|
Barium-140
|
0.01
|
1,110,000
|
30,000
|
Bismuth-207
|
0.01
|
185,000
|
5,000
|
Bismuth-210
|
0.01
|
22,200
|
600
|
Cadmium-109
|
0.01
|
37,000
|
1,000
|
Cadmium-113
|
0.01
|
2,960
|
80
|
Calcium-45
|
0.01
|
740,000
|
20,000
|
Californium-252 9
(20 mg)
|
|
0.001
|
333
|
Carbon-14 (Non-CO2) 1,850,000
|
50,000
|
|
0.01
|
Cerium-141
|
0.01
|
370,000
|
10,000
|
Cerium-144
|
0.01
|
11,100
|
300
|
Cesium-134
|
0.01
|
74,000
|
2,000
|
Cesium-137
|
0.01
|
111,000
|
3,000
|
Chlorine-36
|
0.5
|
3,700
|
100
|
Radioactive Material
1/
Release Fraction
|
Quantity (GBq)
|
|
Quantity (Ci)
|
Chromium-51
|
0.01
|
11,100,000
|
300,000
|
Cobalt-60 5,000
|
0.001
|
|
185,000
|
Copper-64
|
0.01
|
7,400,000
|
200,000
|
Curium-242 60
|
0.001
|
|
2,220
|
Curium-243 3
|
0.001
|
|
110
|
Curium-244 4
|
0.001
|
|
148
|
Curium-245 2
|
0.001
|
|
74
|
Europium-152
|
0.01
|
18,500
|
500
|
Europium-154
|
0.01
|
14,800
|
400
|
Europium-155
|
0.01
|
111,000
|
3,000
|
Gadolinium-153 5,000
|
|
0.01
|
185,000
|
Germanium-68 2,000
|
|
0.01
|
74,000
|
Gold-198
|
0.01
|
1,110,000
|
30,000
|
Hafnium-172
|
0.01
|
14,800
|
400
|
Hafnium-181
|
0.01
|
259,000
|
7,000
|
Holmium-166m. 100
|
|
0.01
|
3,700
|
Hydrogen-3
|
0.5
|
740,000
|
20,000
|
Indium-114m.
|
0.01
|
37,000
|
1,000
|
Iodine-125.
|
0.5
|
370
|
10
|
Iodine-131
|
0.5
|
370
|
10
|
Iridium-192 40,000
|
0.001
|
|
1,480,000
|
Iron-55
|
0.01
|
1,480,000
|
40,000
|
Iron-59
|
0.01
|
259,000
|
7,000
|
Krypton-85
|
1.0
|
222,000,000
|
6,000,000
|
Lead-210
|
0.01
|
296
|
8
|
Manganese-56
|
0.01
|
2,220,000
|
60,000
|
Mercury-203
|
0.01
|
370,000
|
10,000
|
Molybdenum-99 30,000
|
|
0.01
|
1,110,000
|
Neptunium-237 2
|
|
0.001
|
74
|
Nickel-63
|
0.01
|
740,000
|
20,000
|
Niobium-94
|
0.01
|
11,100
|
300
|
Phosphorus-32 100
|
|
0.5
|
3,700
|
Phosphorus-33 1,000
|
|
0.5
|
37,000
|
Polonium-210
|
0.01
|
370
|
10
|
Potassium-42
|
0.01
|
333,000
|
9,000
|
Promethium-145 4,000
|
|
0.01
|
148,000
|
Promethium-147 4,000
|
|
0.01
|
148,000
|
Radium-226 100
|
0.001
|
|
3,700
|
Ruthenium-106 200
|
|
0.01
|
7,400
|
Samarium-151
|
0.01
|
148,000
|
,000
|
Scandium-46
|
0.01
|
111,000
|
3,000
|
Selenium-75
|
0.01
|
370,000
|
10,000
|
Silver-110m.
|
0.01
|
37,000
|
1,000
|
Radioactive Material
1/
Release Fraction
|
Quantity (GBq)
|
|
Quantity (Ci)
|
Sodium-22
|
0.01
|
333,000
|
9,000
|
Sodium-24
|
0.01
|
370,000
|
10,000
|
Strontium-89
|
0.01
|
111,000
|
3,000
|
Strontium-90
|
0.01
|
3,330
|
90
|
Sulfur-35
|
0.5
|
33,30
|
900
|
Technetium-99 10,000
|
|
0.01
|
370,000
|
Technetium-99m 400,000
|
|
0.01
|
14,800,000
|
Tellurium-127m 5,000
|
|
0.01
|
185,000
|
Tellurium-129m 5,000
|
|
0.01
|
185,000
|
Terbium-160
|
0.01
|
148,000
|
4,000
|
Thulium-170
|
0.01
|
148,000
|
4,000
|
Tin-113
|
0.01
|
70,000
|
10,000
|
Tin-123
|
0.01
|
111,000
|
3,000
|
Tin-126
|
0.01
|
37,000
|
1,000
|
Titanium-44
|
0.01
|
3,700
|
100
|
Vanadium-48
|
0.01
|
259,000
|
7,000
|
Xenon-133
|
1.0
|
33,300,000
|
900,000
|
Yttrium-91
|
0.01
|
74,000
|
2,000
|
Zinc-65
|
0.01
|
185,000
|
5,000
|
Zirconium-93
|
0.01
|
14,800
|
400
|
Zirconium-95
|
0.01
|
185,000
|
5,000
|
Any other beta-gamma emitter 370,000
|
10,000
|
|
0.01
|
Radioactive Material
1/
Release Fraction
|
Quantity (GBq)
|
|
Quantity (Ci)
|
Mixed fission products 37,000
|
1,000
|
|
0.01
|
Mixed corrosion products 370,000
|
10,000
|
|
0.01
|
Contaminated equipment, beta-gamma 370,000.
|
10,000
|
|
0.001
|
Irradiated material, any form other than solid noncombustible 37,000
|
1,000
|
|
0.01
|
Irradiated material, solid noncombustible 370,000
|
10,000
|
|
0.001
|
Mixed radioactive waste, beta-gamma 37,000
|
1,000
|
|
0.01
|
Packaged mixed waste,
2/
beta-gamma 370,000
|
10,000
|
|
0.001
|
Any other alpha emitter 74
|
2
|
|
0.001
|
Contaminated equipment, alpha 740.
|
20
|
|
0.0001
|
Packaged waste, alpha
2/
740
|
20
|
|
0.0001
|
1/
For combinations of radioactive materials, the licensee is required to consider whether an emergency plan is needed if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material above exceeds one.
2/
Waste packaged in Type B containers does not require an emergency plan.
SECTION 79. DHS 157 APPENDIX T is created to read:
APPENDIX T
NATIONALLY TRACKED SOURCE THRESHOLDS
The Terabecquerel (TBq) values are the regulatory standard. The curie (Ci) values specified are obtained by converting from the TBq value. The curie values are provided for practical usefulness only and are rounded after conversion.
Radioactive material
|
Category 1
(TBq)
|
Category 1
(Ci)
|
Category 2
(TBq)
|
Category 2
(Ci)
|
Actinium-227
|
20
|
540
|
0.2
|
5.4
|
Americium-241
|
60
|
1,600
|
0.6
|
16
|
Americium-241/Be
|
60
|
1,600
|
0.6
|
16
|
Californium-252
|
20
|
540
|
0.2
|
5.4
|
Cobalt-60
|
30
|
810
|
0.3
|
8.1
|
Curium-244
|
50
|
1,400
|
0.5
|
14
|
Cesium-137
|
100
|
2,700
|
1
|
27
|
Gadolinium-153
|
1,000
|
27,000
|
10
|
270
|
Iridium-192
|
80
|
2,200
|
0.8
|
22
|
Plutonium-238
|
60
|
1,600
|
0.6
|
16
|
Plutonium-239/Be
|
60
|
1,600
|
0.6
|
16
|
Polonium-210
|
60
|
1,600
|
0.6
|
16
|
Promethium-147
|
40,000
|
1,100,000
|
400
|
11,000
|
Radium-226
|
40
|
1,100
|
0.4
|
11
|
Selenium-75
|
200
|
5,400
|
2
|
54
|
Strontium-90
|
1,000
|
27,000
|
10
|
270
|
Thorium-228
|
20
|
540
|
0.2
|
5.4
|
Thorium-229
|
20
|
540
|
0.2
|
5.4
|
Thulium-170
|
20,000
|
540,000
|
200
|
5,400
|
Ytterbium-169
|
300
|
8.100
|
3
|
81
|
Notice of Hearings
Revenue
NOTICE IS HEREBY GIVEN That pursuant to ss.
125.03 (1) (b)
and
125.545 (6) (b)
, Stats., the Department of Revenue will hold public hearings to consider emergency rules and the creation of permanent rules revising Chapter
Tax 2
, relating to combined reporting for corporation franchise and income tax purposes.
This proposed rule order will:
•
Reflect the changes in Wisconsin's franchise and income tax laws affected by
2009 Act 2
, and
•
Provide guidance to taxpayers and Department employees so they can properly apply the Wisconsin franchise and income tax laws.
Hearing Information
The hearings will be held:
Date and Time:
|
Location:
|
September 25, 2009
at 9:00 a.m.
|
Events Room
State Revenue Building
2135 Rimrock Road
Madison, Wisconsin
|
October 16, 2009
at 9:00 a.m.
|
Events Room
State Revenue Building
2135 Rimrock Road
Madison, Wisconsin
|
Copies of Proposed Rules
A copy of the full text of the proposed rule order and the full fiscal estimate may be obtained at no cost by contacting the department. See
Agency Contact Person
listed below.
Submission of Written Comments
Interested persons are invited to appear at the hearings and may make an oral presentation. It is requested that written comments reflecting the oral presentation be given to the department at the hearings. Written comments may also be submitted to the
Agency Contact Person
listed below no later than October 16, 2009, and will be given the same consideration as testimony presented at the hearing.
Agency Contact Person
Wendy Miller
Department of Revenue
Mail Stop 6-40
2135 Rimrock Road
P.O. Box 8933
Madison, WI 53708-8933
Telephone: (608) 266-7177
Analysis Prepared by the Department of Revenue:
Statute interpreted
Statutory authority
General rulemaking authority in s.
227.24
, Stats.; specific rulemaking authority granted in s.
71.255
, Stats., as follows:
•
Section
71.255 (6) (b) 2.
and
(c) 2.
, Stats., relating to net business loss carryforwards, credits, and credit carryforwards.
•
Section
71.255 (7) (a)
, Stats., relating to identifying the designated agent.
•
Section
71.255 (11)
, relating to the adoption of federal treasury regulations so that transactions among combined group members are treated consistently with transactions among federal consolidated group members.
Related statute or rule
Sections
71.24 (1)
,
(1m)
, and
(7)
,
71.29
,
71.44 (1)
,
(1m)
, and
(3)
,
71.77
,
71.82
,
71.83
, and
71.84
, Stats.
Plain language analysis
This rule creates eight new rule sections. The purpose of each rule section is provided below:
Section
Tax 2.60
Definitions Relating to Combined Reporting.
Provides
definitions relating to the other rule sections created by this rule order. Those other sections are ss.
Tax 2.61
,
2.62
,
2.63
,
2.64
,
2.65
,
2.66
, and
2.67
.
•
Explains who must use combined reporting.
•
Provides rules for determining whether a corporation is a member of a "commonly controlled group."
•
Explains when a corporation's income is not subject to combination because of the degree of the corporation's activity outside the U.S. ("water's edge" rules).
•
Explains how to compute the combined group's combined unitary income, including the applicability of federal regulations that relate to consolidated groups. The following components of the computation are covered:
•
Intercompany transactions
•
Capital gains and losses
•
Charitable contributions
•
Dividends
•
Stock basis adjustments
•
Earnings and profits
•
Allocation of expenses and deductions
•
Explains how to apportion the combined unitary income and rules that apply to various aspects of the apportionment computation.
•
Provides rules for determining the taxable income of combined groups that are not subject to apportionment.
•
Describes how to apply net business loss carryforwards, including rules relating to the sharing of net business losses.
•
Describes how to apply credits, including rules relating to the sharing of research credits.
•
Explains the concept of a "unitary business" and its relationship to the concept of a "combined group."
•
Enumerates several characteristics that are indicators of a "unitary business."
•
Lists some key U.S. Supreme Court cases which provide further guidance on the extent to which a business enterprise is considered a "unitary business" under the U.S. Constitution. This is significant because the statute provides that "unitary business" shall be construed to the broadest extent permitted by the U.S. Constitution.
•
Provides several presumptions to aid taxpayers in determining whether a unitary business exists.
•
Provides specific rules relating to the inclusion of passive holding companies and pass-through entities in the unitary business.
Section
Tax 2.63
Controlled Group Election.
•
Explains how to make the election and how to renew it after its 10-year duration.
•
Provides rules relating to the department's authority to disregard the election in cases where it has the primary effect of tax avoidance rather than its intended purpose of simplifying the determination of who must be included in the combined report.
Section
Tax 2.64
Alternative Apportionment for Combined Groups Including Specialized Industries.
•
Specifies how and when a qualifying group may file a petition for alternative apportionment and what information must be submitted to the department.
•
Provides that once the department approves the alternative method, that same method must be used for a 7-year period, subject to a limitation that the tax computation under the alternative method cannot be lower than what it would have been if each corporation apportioned its income separately.
Section
Tax 2.65
Designated Agent of Combined Group.
•
Explains how to identify which corporation is responsible to act on behalf of the combined group for matters relating to the combined return.
•
Defines the scope and limitations of the agency relationship.
Section
Tax 2.66
Combined Estimated Tax Payments.
•
Explains when a combined group member may make its own estimated payments, rather than having the designated agent make the payments on its behalf.
•
Provides rules for determining the combined group's required estimated tax payments.
•
Provides rules for applying estimated payments and overpayments of prior year estimated payments.
•
Enumerates the required components of a combined return and explains how to report separate entity items.
•
Explains how to determine the taxable year of a combined return.
•
Provides rules relating to interest, penalties, and statutes of limitations as they relate to combined returns.
Comparison with federal regulations
The rules are very similar to the federal regulations relating to consolidated groups. The federal regulations listed below are specifically referenced or adopted in this rule order, but modified to apply to combined groups instead of federal consolidated groups.
•
Treas. Reg. §
1.1502
-13, relating to intercompany transactions. This federal regulation was actually adopted by statute (s.
71.255 (4) (g)
, Stats.), but is interpreted in this rule order (s.
Tax 2.61 (6) (b)
).
The general purpose of the above federal regulations is to treat the members of a federal consolidated group as if they were divisions of a single corporation. Likewise, the purpose of adopting these rules for Wisconsin purposes is to treat the members of a combined group as if they were divisions of a single corporation.
Comparison with rules in adjacent states
Illinois
Illinois has comprehensive regulations relating to its combined reporting statute. (including IL Regs. 100.2340, 100.2570, 100.5200, 100.5201, 100.5210, 100.5220, 100.5230, 100.5240, 100.5250, 100.5260, 100.5265, 100.5280, and 100.9700). The following aspects of the rules in this rule order were modeled after the Illinois regulations, with some modifications:
•
Adoption of federal consolidated return regulations
•
Combined estimated tax payments
•
Rules relating to the duties of the designated agent
Iowa
Iowa does not have a statute which permits or allows combined reporting. Thus, it has no rules or regulations relating to combined reporting.
Michigan
Michigan adopted combined reporting in 2008, when it enacted its Michigan Business Tax. At the time this rule order was authored, Michigan has not yet promulgated rules or regulations relating to its combined reporting statute. However, Michigan has published an extensive amount of guidance in the form of Frequently Asked Questions.
Minnesota
Like Illinois, Minnesota has rules relating to its combined reporting statute (including Rules 8019.0100, 8019.0300, 8019.0405, and 8019.0500, Minn. Rules). The section of this rule order that provides guidance in determining a "unitary business" (s.
Tax 2.62
) is modeled after Minnesota's rule 8019.0100, with some modifications.
Summary of factual data and analytical methodologies
The department developed these regulations based upon research of the combined reporting laws, rules, regulations, published guidance, and tax form instructions of other states. The Illinois and Minnesota regulations referenced above were frequently used as a resource, in addition to various law journal articles and tax publications.
The combined reporting regulations recently promulgated by Massachusetts (830 CMR 63.32B.2) were heavily relied upon. The Massachusetts combined reporting law (M.G.L. c. 63 §32B), like Wisconsin's, is first effective for taxable years beginning on or after January 1, 2009, and Wisconsin's law has many similarities with the Massachusetts law.
The department also studied the regulations under section
1502
of the Internal Revenue Code, relating to consolidated returns.
Analysis and supporting documents used to determine effect on small business
Combined reporting primarily affects larger corporations, rather than small businesses. Combined reporting is required for regular "C" corporations, but is not required for the types of entities that are more characteristic of small businesses, such as:
•
Sole proprietorships,
•
Partnerships,
•
Limited liability companies taxed as partnerships, and
•
S corporations
Anticipated costs incurred by private sector
This proposed rule does not have a significant fiscal effect on the private sector independently from the statute it interprets.
Small Business Impact
This proposed rule does not have a significant effect on small business.
Fiscal Estimate
The proposed rules create Tax 2.60 through 2.67 to incorporate tax law changes included in
2009 Act 2
and
2009 Act 28
related to combined reporting for commonly controlled groups of corporations.
The fiscal effect from implementation of combined reporting was included in the fiscal effect for Act 2, and the fiscal effect of certain changes to combined reporting that were a part of Act 28 were included in the fiscal effect for the Act. Therefore, the proposed rules have no fiscal effect.
Wisconsin Technical College System Board
The Wisconsin Technical College System Board proposes an order to revise section
TCS 10.03 (3)
, relating to statutory residents. Public hearing and notice are not required under s.
227.16 (2) (b)
, Stats., as the proposed rule amendment brings the existing rule into conformity with s.
38.22 (6)
, Stats.
Analysis Prepared by the Wisconsin Technical College System Board
Statutes interpreted
Statutory authority
Explanation of agency authority
Pursuant to s.
38.22 (4)
, Stats., the Technical College System Board shall establish procedures to determine the residence of students attending district schools.
Related statute or rule
Plain language analysis
The 2009-11 state budget bill,
2009 Wisconsin Act 28
, added new state residency provisions for tuition purposes for persons who are not residents of the state, but who are enrolled in a technical college district and who meet three eligibility requirements: they graduated from a Wisconsin high school or received a Wisconsin HSED; they have been continuously present in the state for the three years following their enrollment in a Wisconsin high school or preceding receipt of a Wisconsin HSED; and upon enrollment in a technical college, they demonstrate proof of filing (or intent to file) for a permanent U.S. resident visa as soon as they are eligible. In addition, previous legislation added s.
38.22 (6) (f)
relating to the residency status for tuition purposes for certain veterans, which was never codified into administrative rule.
Comparison with federal regulations
Not applicable.
Comparison with rules in adjacent states
Not applicable.
Summary of factual data and analytical methodologies
Not applicable.
Text of Rule
SECTION 1. TCS 10.03 (3) (e) and (f) are created to read:
TCS 10.03 (3) (e) Any person who is a citizen of a country other than the United States if that person meets all of the following requirements:
1. The person graduated from a high school in this state or received declaration of equivalency of high school graduation from this state.
2. The person was continuously present in this state for at least 3 years following the first day of attending a high school in this state or immediately preceding receipt of a declaration of equivalency of high school graduation.
3. The person enrolls in a district school and provides the district board with proof that the person has filed or will file an application for a permanent resident visa with U.S. Citizenship and Immigration Services as soon as the person is eligible to do so.
(f) Any person verified by the department of veterans affairs as being a resident of this state under s.
38.24 (8) (a)
, Stats.
Small Business Impact
Not applicable.
Fiscal Estimate
The functions required by this rule can be absorbed within existing staff. Therefore, there is no fiscal effect on the agency.
Contact Person
Questions concerning this rule may be directed to Morna Foy, Executive Assistant, Wisconsin Technical College System, 4622 University Avenue, P.O. Box 7874, Madison, Wisconsin 53707-7874; telephone (608) 266-2449, e-mail
morna.foy@wtcsystem.edu
.