Rule-Making Notices (Hearing Notices)

NOTICE IS HEREBY GIVEN that pursuant to ss. 101.02 (1) and 101.17, Stats., the Department of Commerce will hold a public hearing on proposed rules under chapter Comm 34 relating to amusement rides.

Hearing Information

The public hearing will be held as follows:

Date and Time:	Location:
October 15, 2007 Monday	Conference Room 3B Thompson Commerce Center
1:00 p.m.	201 W. Washington Avenue
	Madison

Interested persons are invited to appear at the hearing and present comments on the proposed rules. Persons making oral presentations are requested to submit their comments in writing. Persons submitting comments will not receive individual responses. The hearing record on this proposed rulemaking will remain open until October 25, 2007, to permit submittal of written comments from persons who are unable to attend the hearing or who wish to supplement testimony offered at the hearing. Written comments should be submitted to Jim Quast, at the Department of Commerce, P.O. Box 2689, Madison, WI 53701-2689, or Email at [e-mail].

This hearing is held in an accessible facility. If you have special needs or circumstances that may make communication or accessibility difficult at the hearing, please call [phone] or [phone] (TTY) at least 10 days prior to the hearing date. Accommodations such as interpreters, English translators, or materials in audio tape format will, to the fullest extent possible, be made available upon a request from a person with a disability.

Analysis Prepared by Department of Commerce

Statutes interpreted

Section 101.17, Stats.

Statutory authority

Sections 101.02 (1) and 101.17, Stats.

Related statute or rule

Statutes: Sections 101.19 and 101.12 (1), Stats.

Administrative Rules: Ch. Comm 34, Amusement Rides

Explanation of agency authority

Under the authority of s. 101.17, Stats., the Department of Commerce has oversight of various mechanical devices and equipment, which includes amusement rides, in order to protect public safety. The Department fulfills this responsibility by promulgating the Amusement Ride Code, under chapter Comm 34.

Summary of proposed rules

The proposed rules will require amusement ride owner to acquire and maintain liability insurance in order to operate rides in Wisconsin.

The proposed rules also create safety field attachment or connection redundancy provisions for amusement rides where passengers donning harnesses are elevated.

Comparison with federal regulations

The US Consumer Product Safety Commission under the Consumer Product Safety Act has jurisdiction over portable amusement rides. The commission has not developed any specific standard for portable amusement rides. At times the commission has issued various safety bulletins regarding operation, repair, maintenance or set-up for specific rides.

There are no existing or proposed federal regulations that address the specific issue of this rule.

Comparison with adjacent states

A review of the amusement ride insurance regulations for the states of Illinois, Iowa, Michigan and Minnesota indicated the following liability minimums:

•   Illinois, $100,000 for injury to one person, $1,000,000 in aggregate, $500,000 in aggregate for permanent sites with not more than 5 rides and operating at a height not more than 8 feet.

•   Iowa, $100,000 for injury to one person, $300,000 in aggregate.

•   Michigan, $300,000 in aggregate, $50,000 in aggregate if owner has only one ride designed primarily for children.

•   Minnesota, $1,000,000 in aggregate.

An Internet-based search of the amusement ride regulatory programs for the states of Illinois, Iowa, Michigan and Minnesota found that none of the states have specific rules or standards regarding the field attachment or connection of passengers as addressed by the proposed rules.

Factual data and analytical methodologies

The proposed rules were developed utilizing information gathered during the department's investigation of the recent accident. The department also evaluated the current provisions of the Amusement Ride Code, chapter Comm 34, with respect to industry safety practices that were identified during the department's periodic inspection of rides. The department also reviewed the amusement ride insurance regulations of various states.

Analysis and supporting documents used to determine effect on small business

Currently, approximately 320 amusement ride owners and operators have registered rides with department for 2007. All owners and operators would be required to obtain liability insurance under the proposed rules. The cost of the amusement ride insurance is dependent upon several variables including the size of the operation and the type of rides. An insurance source indicated that the cost for a million dollar policy could range between $30,000 and $100,000 annually. However, it is unknown how many of these owners and operators already are covered by insurance either voluntarily or to satisfy contractual obligations or other state regulations.

Based on a review of the list of 1400 amusement rides registered to operate in Wisconsin for 2007, the department estimates that fewer than 10 rides may fall within the scope of these proposed rules regarding attachment. These rules would not include such amusement rides as bungee jumps, bungee trampolines, and rock walls with mechanical take-up systems.

An economic impact report has not been required to be prepared.

Copy of Rule

The proposed rules and an analysis of the proposed rules are available on the Internet at the Safety and Buildings Division Web site at www.commerce.wi.gov/SB/. Paper copies may be obtained without cost from Roberta Ward, at the Department of Commerce, Program Development Bureau, P.O. Box 2689, Madison, WI 53701-2689, or Email at [e-mail], or at telephone [phone] or [phone] (TTY). Copies will also be available at the public hearing.

Environmental Analysis

NOTICE IS HEREBY GIVEN that 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.

Initial Regulatory Flexibility Analysis

1. Types of small businesses that will be affected by the rules

The rules will affect amusement ride owners and operators.

2. Reporting, bookkeeping and other procedures required for compliance with the rules

Under the proposed rules amusement ride owners and operators will need to keep in place liability insurance will operating in the state.

3. Types of professional skills necessary for compliance with the rules

There are no new types of professional skills necessary for compliance with the rules.

4. Will the rules have a significant economic impact on small businesses?

Yes.

The small business regulatory coordinator for the Department of Commerce is Carol Dunn, who may be contacted at telephone [phone], or Email at [e-mail].

Fiscal Estimate

The proposed rules make permanent emergency rules that clarify the minimum type of attachment or connection of harnessed passengers that are necessary for certain types of amusement rides. The enforcement of the proposed rule will be incorporated into the periodic inspections of department staff. Carabiners which are utilized to make this type of attachment or connection cost between $15 to $25.

The proposed rules would also require amusement ride owners and operators to obtain and keep in place liability insurance while operating in the state. The cost of the amusement ride insurance is dependent upon several variables including the size of the operation and the type of rides. An insurance source indicated that the cost for a million dollar policy could range between $30,000 and $100,000 annually. However, it is unknown how many of these owners and operators already are covered by insurance either voluntarily or to satisfy contractual obligations or other state regulations.

Notice of Hearings

Health and Family Services

(Health, Chs. HFS 110—)

[CR 07-077]

NOTICE IS HEREBY GIVEN that pursuant to ss. 227.11 (2), 252.04 (1), (2), and (10), Stats., and interpreting ss. 252.04 (1) to (7) and (10), Stats., the Wisconsin Department of Health and Family Services proposes to amend ch. HFS 144 relating to the immunization of students and affecting small businesses.

Hearing Information

Date and Time	Location
October 15, 2007 12:00 Noon to 2:00 PM	Waukesha State Office Bldg. 141 N. W. Barstow Street Room 151 Waukesha, WI
October 16, 2007 2:00 PM to 4:00 PM	Lakeview Professional Plaza 1200 Lake View Drive First Floor Dining Room Wausau, WI
October 18, 2007 3:00 PM to 5:00 PM	Dept. of Health and Family Services 1 W. Wilson Street Room B155 Madison, WI

The hearing site is fully accessible to people with disabilities. If you are hearing impaired, do not speak English or have circumstances that might make communication at a hearing difficult; you require an interpreter or a non-English large print or taped version of the proposed rules, contact the person at the address or telephone number given below at least 10 days before the hearing. With less than 10 days notice, an interpreter may not be available.

Submission of Written Comments

Written comments may be submitted at the public hearing or submitted to the contact person listed below. Comments may also be made using the Wisconsin Administrative Rule Website at http://adminrules.wisconsin.gov.

The deadline for submitting comments to the Department is 4:30 p.m. on October 25, 2007.

Analysis Prepared by the Department of Health and Family Services

Under section 252.04 (1), Stats., the Department is responsible for carrying out a statewide immunization program to eliminate mumps, measles, rubella (German measles), diphtheria, pertussis (whooping cough), poliomyelitis, and other diseases that the Department specifies by rule, and to protect against tetanus. To achieve this goal, any student admitted to a day care center, or a nursery, elementary, middle, junior or senior high school is required to present written evidence of having completed the immunizations for each vaccine required for the student's grade. The immunization requirement is waived if the student's parent, guardian or legal custodian submits a written statement to the school or day care center objecting to the immunization for reasons of health, religion or personal conviction. The most recent additions to the list of diseases against which students are to be immunized are hepatitis B (1997) and varicella (chickenpox) (2001). During the past six years, a new vaccine [pneumococcal conjugate vaccine (PCV)] and a new formulation of an existing vaccine [tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap)] have been licensed, a change in the number of doses of a licensed vaccine (varicella vaccine) has been recommended, and the phase-in periods for hepatitis B and varicella vaccine requirements have ended. Therefore, the Department proposes to amend ch. HFS 144, rules governing immunization of students, to accomplish the following:

1.   Add pneumococcal infection to the list of diseases in ch. HFS 144 against which students in day care centers are to be immunized because PCV has been shown to be highly effective in reducing diseases caused by pneumococcus, e.g., pneumonia, bacteremia, sinusitis and acute otitis media (middle ear infection), among children less than 5 years of age. The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) recommended this vaccine for all children 2-23 months of age, and for children 24-59 months of age who attend day care centers, in 2000.

2.   Add Tdap to ch. HFS 144 Table 144.03-A because this vaccine can be given to adolescents. Immunizing older students will prevent pertussis outbreaks in schools and will indirectly protect infants too young to be fully immunized. From 1986 through 2004, Wisconsin had the fifth highest incidence of pertussis in the nation. The ACIP recommended this vaccine for all children at 11-12 years of age in 2005.

3.   Add a second dose of varicella vaccine to ch. HFS 144 Table 144.03-A because two doses of the vaccine have been shown to be more effective than one dose in preventing breakthrough cases. In 2005, the ACIP provisionally recommended two doses of varicella vaccine for all children 1 through 12 years of age and the passage of middle school and high school varicella vaccine requirements.

4.   Remove hepatitis B and varicella vaccine coverage phase-in language because these phase-in time periods have passed and the language is no longer necessary.

In addition, the Department proposes the following to update ch. HFS 144:

5.   Add language stating that the Department may temporarily suspend a vaccine requirement if the Department determines that there is a shortage of the vaccine because a student could not possibly obtain a required vaccine in such circumstances.

6.   Revise the definition of “written evidence of immunization" to include electronic records because immunization registries used by many providers store immunization data that are accessible to schools electronically.

7.   Change the language regarding release of immunization information between vaccine providers and schools or day care centers, and among providers, from discretionary to mandatory to create a clear requirement for disclosure.

The intended goals of the proposed rulemaking are to:

•   Prevent pneumococcal infections, pertussis infections and break-through varicella infections among students;

•   Update the rules by deleting obsolete sections and adding clarifying language; and

•   Create a clear requirement for disclosure of immunization information.

An alternative to regulatory action is promotion of these vaccine recommendations to parents and immunization providers. Allowing time to elapse between licensure of a vaccine and enacting a school requirement has traditionally allowed market forces to increase the number of immunized children. However, coverage achieved through voluntary compliance with vaccine recommendations is always lower than that achieved through regulation. Before states enacted school vaccine requirements, outbreaks of vaccine-preventable diseases continued long after vaccine licensure because vaccine coverage was suboptimal. For example, although an effective measles vaccine was licensed in 1967, measles outbreaks involving thousands of Wisconsin children continued to occur until a school requirement was set in place in 1980.

Initial Regulatory Flexibility Analysis

Approximately 60% of children in Wisconsin have private health insurance. There are 122 direct health and medical insurance carriers in Wisconsin with a total of 23,000 paid employees. The only health care insurers in Wisconsin that meet the definition of a small business in s. 227.114 (1), Stats., are limited scope health plans that, for example, only offer dental or vision coverage. Health care insurers that offer comprehensive coverage for pediatric health care, including immunizations, do not meet the definition of a small business.

Day care centers are organized as small businesses [about 95% of the 2,485 group (9 or more children) day care centers in the state are small businesses, as are all of the 3,122 family (4-8 children) day care centers]. Day care centers will experience some increase in workload in tracking compliance with the requirement for PCV, reporting compliance to the Department, and in referring noncompliant students to the district attorney or corporation counsel for enforcement action. It is not known how much workload will increase or its impact, if any, on costs. However, since 85% of children in Wisconsin have already received PCV, the vast majority of day care center students will be compliant with the requirement when it takes effect and will not require warning letters from day care centers or enforcement action by district attorneys. Additionally, the tracking and reporting burden on day care centers will be mitigated by requiring fewer than the maximum number of doses of PCV. Day care centers for many years have been checking for compliance with required immunizations for school entry. They are part of the system for protecting children against diseases that are preventable through administration of approved vaccines.

Day care centers are the only small businesses that the proposed rules will affect. Pursuant to the foregoing analysis, the Department believes that these rules will not have a significant economic impact on day care centers.

Small Business Regulatory Coordinator

Rosie Greer

[e-mail]

608-266-1279

Fiscal Estimate

This rulemaking requires pneumococcal conjugate vaccine (PCV), a new formulation of diphtheria, tetanus and pertussis (whooping cough) vaccine (Tdap), and a second dose of varicella (chickenpox) vaccine for students. The vaccines the Department provides upon request and without charge to local health departments and private health care providers is purchased by the Department with a line of credit provided by the federal government's Centers for Disease Control and Prevention (CDC) or with GPR funds under s. 20.43 (1) (cm), Stats. Section 20.43 (1) (cm), Stats., authorizes the Department to expend an amount that is equal to the difference between the statutory limit of a $9,000,000 sum sufficient appropriation and the amount of funding the Department receives for the federal Vaccines for Children Program (VFC) and Section 317 of the Public Health Service Act. VFC funds are sum sufficient. Federal 317 funds are not guaranteed to meet actual need but have been sufficient to cover the vaccine costs associated with the Department's implementation of previous vaccine requirements. The total estimated cost for vaccine to implement the proposed requirements in the 2008-09 school year is $22 million; the possible annual cost to the state, in the unlikely event that no 317 funds are available, is $3.6 million.

The following assumptions were used to estimate costs:

•   PCV: The vaccine costs $73.70 in the private sector and $57.59 in the public sector; 85% of children have already received PCV vaccine; 50% of children are enrolled in a day care center; 5% of students' parents will elect to waive the requirement. Thus, of a total annual cohort of 359,000 0-4 year olds, 25,500 students will require vaccine. Private providers will pay 59% of the vaccine cost ($1.6 million); the federal VFC Program will pay 21% of the vaccine cost ($434,000); and federal 317 funds or GPR funds will pay 19% of the vaccine costs ($392,000).

•   Tdap Vaccine: The vaccine costs $36.84 in the private sector and $30.75 in the public sector; 20% of the cohort of 6th, 9th and 12th grade students has already been vaccinated; 5% of the students' parents will elect to waive the requirement. Thus, of a total annual cohort of 228,000 students, 182,000 will require vaccine. Private providers will pay 59% of the vaccine cost ($3.8 million), the federal VFC Program will pay 21% of the vaccine cost ($1.1 million, and federal 317 funds or GPR funds will pay 19% of the vaccine costs ($1 million).