CR_10-112 Notice of proposed rulemaking relating to the scheduling of lisdexamfetamine under ch. 961, Stats., of the Uniform Controlled Substances Act (s. CSB 2.35).  

  • Initial regulatory flexibility analysis
    Types of small businesses that will be affected by the rules.
    Businesses that choose to pursue grants for outsourcing work to rural municipalities, under SECTION 45 (1) (b) of 2009 Wisconsin Act 265 .
    Reporting, bookkeeping and other procedures required for compliance with the rules.
    An application must be submitted to the Department, that includes information enabling the Department to determine the corresponding potential economic impacts of a proposed project.
    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.
    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
    Although the rules will newly result in review of documentation relating to issuing grants to businesses for outsourcing work to rural municipalities, the number of these reviews and grants is expected to be too small to result in significant changes in the Department's costs for administering its business development programs. 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 only voluntary submittal of documentation relating to grants for outsourcing work to rural municipalities
    State fiscal effect
    None.
    Local government fiscal effect
    None.
    Long-range fiscal implications
    None known.
    Agency Contact Person
    Mary Gage, Wisconsin Dept. of Commerce
    Bureau of Business Finance and Compliance
    P.O. Box 7970
    Madison, WI 53707-7970
    Phone: (608) 266-2766
    Notice of Proposed Rulemaking
    (Without Public Hearing)
    Controlled Substances Board
    NOTICE IS HEREBY GIVEN that pursuant to ss. 961.11 (1) and 961.16 , Stats., and according to the procedure set forth in s. 227.16 (2) (e) , Stats., the Controlled Substances Board will adopt the following rule as proposed in this notice, without public hearing unless, within 30 days after publication of this notice on September 30, 2010, the Controlled Substances Board is petitioned for a public hearing by 25 natural persons who will be affected by the rule; a municipality which will be affected by the rule; or an association which is representative of a farm, labor, business or professional group which will be affected by the rule.
    Submittal of Written Comments
    Comments may be submitted to Pamela Haack, Department of Regulation and Licensing, Division of Board Services, 1400 East Washington Avenue, Room 116, P.O. Box 8935, Madison, Wisconsin 53708-8935, or by email at pamela.haack@wisconsin.gov . Comments must be received on or before October 15, 2010 to be included in the record of rule-making proceedings.
    Analysis Prepared by the Department of Regulation and Licensing
    Statutes interpreted
    Sections 961.11 (1) and 961.16 , Stats.
    Statutory authority
    Sections 961.11 (1) and 961.16 , Stats.
    Explanation of agency authority
    The Controlled Substances Board is authorized by s. 961.11 (1) , Stats., to add substances to or delete or reschedule substances listed under schedule II, in s. 961.16 , Stats., pursuant to the rule-making procedures of ch. 227 , Stats.
    Related statute or rule
    21 CFR Sec. 1308.12 (d) (5)
    Plain language analysis
    By final rule of the Drug Enforcement Administration (DEA), adopted effective June 4, 2007, lisdexamfetamine was classified as a schedule II controlled substance under the federal Controlled Substances Act (CSA). Lisdexamfetamine has not been so scheduled under the Wisconsin Controlled Substances Act in ch. 961 , Stats. The objective of this proposed rule-making is to bring the treatment of this drug into conformity with that at the federal level.
    Drugs that are classified as "controlled substances" under federal and state laws are subject to higher civil and criminal penalties for their illicit possession, distribution and use. Health care providers are also subject to greater recordkeeping requirements regarding procuring, prescribing and dispensing of such drugs. This is because certain drugs, like lisdexamfetamine, have a greater likelihood of abuse, addiction and adverse consequences to patient health if utilized inappropriately, than do other drugs.
    Lisdexamfetamine is also known by the trade name Vyvanse TM and has the DEA Drug Code 1205. It will be marketed as a prescription drug product for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
    The DEA found reason to classify Lisdexamfetamine, including its salts, isomers, and salts of isomers, as a schedule II drug based on the following findings:
    (1) Lisdexamfetamine has a high potential for abuse;
    (2) Lisdexamfetamine has a currently accepted medical use in treatment in the United States; and
    (3) Abuse of lisdexamfetamine may lead to severe psychological or physical dependence.
    Comparison with federal regulations
    21 CFR Sec. 1308.12 (d) (5)
    Lisdexamfetamine has been classified as a schedule II controlled substance in the federal Controlled Substances Act since June 4, 2007. This regulation change will make Wisconsin regulations consistent with the federal CSA.
    Comparison with rules in adjacent states
    Illinois:
    Not scheduled. Provisions relating to permit authorization application requirements and renewal : Federal registration is required before activity can occur. Illinois grants an "independent activity" license that expires on December 31 of even-numbered years. A registered person who fails to renew before the expiration date of the registration must apply for a new registration. The registration expires on the date specified. Section 3100, Illinois Rules.
    Iowa:
    Schedule II Controlled Substance. House File 2167, Sec. 2. Provisions relating to permit authorization application requirements and renewal : Iowa's regulations identify who must register and include application requirements. A $100 late renewal fee is assessed if there is a failure to remit payment by the first day of the month following expiration. Grounds for revocation, suspension and denial are specified. Section 657, Iowa Administrative Code.
    Michigan:
    Not scheduled. Provisions relating to permit authorization application requirements and renewal : Michigan requires a research license. Rules deal separately with personal training for euthanasia, thefts and diversion, storage, employees and records. Chapter 338 , Michigan Rules.
    Minnesota:
    As of March 8, 2010, Minnesota classified lisdexamfetamine as a schedule II controlled substance.
    Summary of factual data and analytical methodologies
    The Wisconsin Controlled Substances Board reviewed the federal rule summary and supplemental information for the scheduling of this substance, and agrees with the conclusions therein regarding the potential for abuse.
    Analysis and supporting documents used to determine effect on small business
    Since there is no anticipated impact on small business from this rule, no additional compliance, bookkeeping, reporting, recordkeeping or professional skills are required.
    Section 227.137 , Stats, requires an "agency" to prepare an economic impact report before submitting the proposed rule-making order to the Wisconsin Legislative Council. The Department of Regulation and Licensing is not included as an "agency" in this section.
    Anticipated Costs Incurred By Private Sector
    The department finds that this rule has no significant fiscal effect on the private sector.
    Small Business Impact
    These proposed rules will not have any significant economic impact on a substantial number of small businesses, as defined in s. 227.114 (1) , Stats. The Department's Regulatory Review Coordinator may be contacted by email at hector.colon@wisconsin.gov , or by calling (608) 266-8608.
    Fiscal Estimate
    There is no fiscal impact on the department.
    Agency Contact Person
    Pamela Haack
    Department of Regulation and Licensing
    Division of Board Services
    1400 East Washington Avenue, Room 116
    P.O. Box 8935, Madison, WI 53708-8935
    Telephone: (608) 266-0495
    Text of Proposed Rule
    SECTION 1. CSB 2.35 is created to read:
    CSB 2.35 Addition of lisdexamfetamine to schedule II. (1) Section 961.16 (5) (e) is created to read:
    Section 961.16 (5) (e) lisdexamfetamine, commonly known as "Vyvanse TM."
    Notice of Hearing
    Military Affairs
    NOTICE IS HEREBY GIVEN that pursuant to s. 321.45 (2) , Stats.,the Department of Military Affairs will hold a public hearing on emergency rules and the promulgation of permanent rules to create Chapter DMA 1 , relating to Military Family Financial Aid.
    Hearing Information
    Date:   Wednesday, October 13, 2010
    Time:   1:00 p.m. – 2:00 p.m.
    Location:   MADISON
      Witmer Hall
      2400 Wright St.
      Madison, WI 53704
    The public hearing site is accessible to people with disabilities. If you have special needs or circumstances that may make communication or accessibility difficult at the hearing, please contact Randi Milsap at (608) 242-3072.
    Copies of Proposed Rule
    Copies of the proposed rule will be provided at the public hearing. Copies may also be obtained at no charge by emailing a request to Randi Milsap at randi.milsap@wisconsin.gov
    Submittal of Written Comments
    The public record on this proposed rule making will be held open until close of business the day of the hearing to permit the submission of comments in lieu of public hearing testimony or comments supplementing testimony offered at the hearing. Any such comments should be submitted to Randi Milsap, Department of Military Affairs, 2400 Wright St., P. O. Box 14587, Madison, WI 53708-0587. You may also contact Randi Milsap by phone at (608) 242-3072 or email randi.milsap@wisconsin.gov .
    Analysis Prepared by Department of Military Affairs
    Statute interpreted
    Section 321.45 (2) , Wis. Stats.
    Statutory authority
    Section 321.45 (2) , Chapter 321 , Wis. Stats.
    Explanation of agency authority
    The Department of Military Affairs is charged with promulgating rules to administer Military Family Financial Aid under Wis. Stat. 321.45 (2).
    Related statute or rule
    Section 20.465 (2) (r) , Wis. Stats.
    Plain language analysis
    The proposed rule, DMA 1, is being promulgated under the statutory authority of Wis. Stat. s. 321.45 (2) and is designed to provide the process for application and distribution of funds from the military family relief fund for the payment of financial aid to military families as provided under Wis. Stat. s. 20.465 (2) (r) .
    This rule establishes the eligibility criteria, the amount of financial aid and the application process for military family financial aid. The purpose of the military family financial aid is to provide financial support to service members and their immediate families dealing with emergency situations. The rule requires applicants be a member of the immediate family of a service member, that the service member and the applicant are residents of the state, and that the service member is serving on active duty in the U.S. armed forces.
    The application is available free of charge and the fund administrator will make a decision to approve or deny an application within 14 days of the receipt of a completed application. An applicant has 30 days to appeal any final determination by the fund administrator in writing and an addition 30 days to appeal the administrator's decision to the adjutant general.
    A governing board comprised of military officials and the fund's executive director will provide oversight of the family aid process, and application records will be archived for 5 years.
    Comparison with federal regulations
    Each military branch has its own emergency relief organizations. This rule most closely resembles Army Regulation 930-4, which sets out rules for the administration of Army Emergency Relief (AER) assistance.
    Active Duty service members, their dependents, some retired service members, and surviving spouses and orphans of service members who died on active duty are eligible to receive aid through AER. Military Family Financial Aid funds are available only to service members on active duty and their immediate family members. Both Army Emergency Relief and Military Family Financial Aid are funded through donations. Military Family Financial Aid will be administered by a Fund Administration committee as the Wisconsin Department of Military Affairs. Army Emergency Relief provides loans and grants to service members, whereas Military Family Financial Aid provides only grants. That aside, the substantive provisions of the Military Family Financial Aid Rule were based in large part on Army Emergency Relief.
    Comparison with rules in adjacent states
    Illinois:
    The Illinois Military Family Relief Fund (IMFRF) is authorized by Title 95 Chapter 2 Part 200 of the Illinois Administrative Code and is funded by a voluntary check off on Illinois individual income tax forms.
    The IMFRF provides grants to families of Illinois National Guard members and Illinois residents serving in the U.S. Armed Forces Reserve who are called to active duty as a result of the September 11, 2001 terrorist attacks. IMFRF grants are available to help service members and their families defray the costs of food, housing, utilities, medical services, and other expenses that become difficult to afford when a wage-earner.
    The IMFRF provides three tiers of grants. All status and need based grants are awarded on a first-come, first-served basis. A status based grant of $500 is available for National Guard and Reserve soldiers on active duty for a minimum of 60 days with a pay grade below a moderate amount. Members may reapply for the $500 status based grant for every 6 months of consecutive duty.
    A need based grant of $2,000 is available for National Guard and Reserve soldiers on active duty for a minimum of 60 days with a pay grade below a moderate amount and the service member's military salary must be at least 30% less than his or her civilian salary. Members may reapply for the $2,000 need based grant for every 6 months of consecutive duty. A casualty based grant of $5,000 is available for Active Duty, National Guard and Reserve soldiers who suffer a service-connected injury.
    Iowa:
    The State of Iowa has established a Veterans Trust Fund to provide certain services to veterans under Iowa Administrative Code 801 Chapter 14 . As of 2009 the trust fund is funded by a Joint Veterans Trust Fund and volunteer fire fighter preparedness fund income tax check off. Trust fund expenditures are approved through the Iowa Veterans Commission.
    Funds are used for unemployment or underemployment assistance due to service-related causes, assistance with vision, hearing, dental care, durable medical equipment, and prescription drugs; counseling and substance abuse services; housing repair; and transitional housing in an emergency.
    Disbursements are limited to members with income less than 200% of federal poverty level and less than $15,000 in liquid assets. Interest funds are received monthly and approved applicants are placed on a waiting list based on the date received and approved.
    Michigan:
    The Michigan Military Family Relief Fund is authorized by MI ST 35.1211-35.1216 2004 and is funded by a voluntary check off on Michigan individual income tax forms.
    The fund is available to any member of a reserve component of the United States armed forces based in Michigan or who is a resident of Michigan serving in a reserve component of the United States armed forces based in another state and is called to active duty by the president of the United States or the United States secretary of defense as a result of national response to September 11, 2001 or as a response to a national emergency declared by the president of the United States and for which funds are being spent by the federal government.
    The fund provides financial assistance for clothing, food, housing, utilities, medical services or prescriptions, insurance payments, vehicle payments, or other related necessities of daily living. The fund covers needs that occurred during the time the individual was on active duty or needs that occurred because the individual has incurred a line of duty injury or illness. Michigan limits the fund to $2,000 in one calendar year for each individual.
    Minnesota:
    Minnesota does not have a government administrated military family relief fund.
    Summary of factual data and analytical methodologies
    None.
    Analysis and supporting documents used to determine effect on small business
    Not necessary.
    Small Business Impact
    None.
    Agency Contact Person
    Randi Milsap
    Department of Military Affairs
    2400 Wright Street
    Madison, WI 53708
    Telephone: (608) 242-3072
    Notice of Hearing
    Natural Resources
    Fish, Game, Forestry, etc., Chs. NR 1—
    DNR # ER-35-10 and ER-37-10(E)
    NOTICE IS HEREBY GIVEN that pursuant to ss. 23.09 (2) , 29.604 , 227.11 (2) and 227.24 , Stats., the Department of Natural Resources will hold public hearings on proposed emergency and permanent rules to list four cave bat species as threatened in s. NR 27.03 (3) , Wis. Adm. Code. The hearings will be held concurrently with hearings to list the fungus, Geomyces destructans , as a prohibited invasive species in s. NR 40.04 (2) , Wis. Adm. Code.
    Hearing Information
    The hearings will begin at 11:00 am at the locations listed below. Following a brief informational presentation, public comments and statements will be accepted.
    October 25, 2010   Conference Room 1
      DNR Oshkosh Service Center
      625 E. County Rd. Y
      Oshkosh
    October 26, 2010   Glaciers Edge & Gathering Waters Rms.
      DNR South Central Region Hdqrs.
      3911 Fish Hatchery Road
      Fitchburg
    October 28, 2010   Room 185
      DNR West Central Region Hdqrs.
      1300 W. Clairemont
      Eau Claire
    October 29, 2010   Conference Room 1
      DNR Northern Region Headquarters
      107 Sutliff Avenue
      Rhinelander
    Pursuant to the Americans with Disabilities Act, reasonable accommodations, including the provision of informational material in an alternative format, will be provided for qualified individuals with disabilities upon request. Please call Stacy Rowe at (608) 266-7012 with specific information on your request at least 10 days before the date of the scheduled hearing.
    Copies of Proposed Rules and Submittal of Written Comments
    The proposed rule and fiscal estimate may be reviewed and comments electronically submitted at the following Internet site: http://adminrules.wisconsin.gov . Written comments on the proposed rule may be submitted via U.S. mail to Ms. Stacy Rowe, Bureau of Endangered Resources, P.O. Box 7921, Madison, WI 53707 or by email to stacy.rowe@wisconsin.gov . Comments may be submitted until November 1, 2010 . Written comments whether submitted electronically or by U.S. mail will have the same weight and effect as oral statements presented at the public hearings. A personal copy of the proposed rule and fiscal estimate may be obtained from Ms. Rowe.
    Analysis Prepared by Department of Natural Resources
    Statutory authority
    Sections 23.09 (2) , 29.604 , 227.11 (2) and 227.24 , Stats.
    Plain language analysis
    The proposed changes to Ch. NR 27 , Wis. Admin. Code, will add the four cave bat species in Wisconsin to the Wisconsin threatened species list. The four species include the little brown bat ( Myotis lucifugus ), big brown bat ( Eptesicus fuscus ), northern long-eared bat ( Myotis septentrionalis ), and eastern pipistrelle ( Perimyotis subflavus ).
    Related statute or rules
    Section 29.604 (3) , Wis. Stats., requires the Department to establish an endangered and threatened species list. Chapter NR 27 , Wis. Admin. Code, provides the list of endangered and threatened species.
    Comparison with federal regulations
    Although several species of cave bats are listed federally by the United States Fish and Wildlife Service (USFWS), we are not aware of any listings that have occurred specifically due to white-nose syndrome. However, USFWS has received a petition to list two cave bat species due to white-nose syndrome and is in the process of reviewing the petition.
    Comparison with rules in adjacent states
    Vermont, New York and Massachusetts are in the process of listing several cave bat species due to white-nose syndrome.
    The Minnesota Department of Natural Resources has recently proposed the little brown bat ( Myotis lucifugus ) and big brown bat ( Eptesicus fuscus ) as species of special concern because of the eminent threat of white-nose syndrome in the state. The other two species of cave bats in Minnesota, northern long-eared bat ( Myotis septentrionalis ) and eastern pipistrelle ( Perimyotis subflavus ) are already listed as species of special concern in Minnesota.
    Summary of factual data and analytical methodologies
    The proposed emergency rule is related to the addition of Wisconsin's four cave bat species to the state's threatened species list. The four species include the little brown bat ( Myotis lucifugus ), big brown bat ( Eptesicus fuscus ), northern long-eared bat ( Myotis septentrionalis ), and eastern pipistrelle ( Perimyotis subflavus ).
    The proposed rule change seeks to provide protection to Wisconsin cave bat species, which face the imminent threat of white-nose syndrome. White-nose syndrome has spread across 14 states and 2 Canadian provinces in the last 3 years, spreading up to 800 miles per year. Mortality rates of affected bat colonies reach 100%. The disease was located last spring within 225 miles of Wisconsin's southern boarder and 300 miles from the northern boarder. Because the known dispersal distance of the little brown bat is 280 miles, an affected cave is now located within the dispersal range of Wisconsin little brown bats. Based on the current location and known rate of spread of the disease, we anticipate the presence of white-nose syndrome in Wisconsin as early as January 2011.
    Wisconsin has one of the highest concentrations of cave bat hibernacula in the Midwest and large numbers of cave bats from neighboring states hibernate in Wisconsin. Consequently, Wisconsin's cave bat population, and those of surrounding states, is threatened by this devastating disease. All Wisconsin bat species are among the species fatally affected by the white-nose syndrome.
    Cave bats were assessed for changes in population condition, using the following triggers established by the Bureau of Endangered Resources:
    1.   Significant change in the Natural Heritage Inventory State Rank since 1997.
    2.   Significant change in the Natural Heritage Inventory Global Rank since 1997.
    3.   Change in United States Endangered Species Act status since 1997.
    4.   Is there a need for immediate protection (i.e., new threat).
    5.   Change in other statuses, e.g., International Union for Conservation of Nature (IUCN), Convention on International Trade in Endangered Species (CITES).
    6.   New data on population condition available.
    7.   Recommended for listing/delisting since 1997.
    8.   Taxonomic change.
    9.   For currently listed species, have recovery goals been met.
    All four cave bat species met triggers #1 and #4, and the little brown bat also met trigger #7 (recommended for listing by stakeholders), therefore indicating the need for the emergency rule change.
    Listing these species before white-nose syndrome has been detected in Wisconsin will allow the Department time to work collaboratively with stakeholders to ensure that appropriate conservation measures are developed and in place. Because of the speed of white-nose syndrome, the Department would not have time to develop appropriate conservation measures if listing were delayed until after white-nose syndrome was detected in Wisconsin.
    Analysis and supporting documents used to determine effect on small business
    None.
    Small Business Impact
    Affected constituencies include commercial caves and mines, private cave and mine owners, recreational cavers, wildlife rehabilitators, animal control operators, the agricultural industry, the conservation community, wind utilities, WI Department of Transportation (WDOT) and homeowners. Concerns will likely include how listing the bats will affect current activities. Many of these potential concerns will be addressed through a broad incidental take permit/authorization and voluntary agreements so that the listing does not have a significant economic impact on a substantial number of small businesses.
    A broad incidental take permit/authorization would be created, as provided for under s. 29.604 , Wis. Stats. The broad incidental take permit/authorization would allow for the incidental taking of state listed cave bats that may occur as a result of specific public health concerns, bat removals, building demolitions, forestry activities, bridge demolitions, miscellaneous building repairs and wind energy development projects (see the "Broad Incidental Take Permit/Authorization for Cave Bats" attachment for more information). Some take of bats may still occur as a result of these activities, however take will be minimized by following specific minimization measures and the department has concluded that the projects covered under this permit are not likely to jeopardize the continued existence and recovery of the state population of these bats or the whole plant-animal community of which they are a part; and has benefit to the public health, safety or welfare that justifies the action. This incidental take permit/authorization is only needed when a bat is present or suspected to be present (e.g., Natural Heritage Inventory report of bats in the area, evidence of bat presence).
    Pursuant to s. 227.114 , Stats., it is not anticipated that the proposed rule will have a significant economic impact on small businesses.
    Small business regulatory coordinator
    The Department's Small Business Regulatory Coordinator may be contacted at SmallBusiness@dnr.state.wi.us or by calling (608) 266-1959.
    Environmental Impact
    The Department has made a preliminary determination that this action does not involve significant adverse environmental effects and does not need an environmental analysis under ch. NR 150 , Wis. Adm. Code. However, based on the comments received, the Department may prepare an environmental analysis before proceeding with the proposal. This environmental review document would summarize the Department's consideration of the impacts of the proposal and reasonable alternatives.
    Fiscal Estimate
    Rule summary
    The proposed rule package amends Ch. NR 27 , Wis. Adm. Code to add four species of bats to the endangered and threatened species list. This addition to the invasives list is being proposed as both an emergency rule, ER-37-10 (E), and a permanent rule, ER-35-10.
    State fiscal estimate
    The proposed rule package will require time by DNR staff to prepare the rule and administer rule hearings. Endangered Resources review staff will likely see an increase in time associated with the listing of bats. There will be an increase in the time associated with incidental take permits. It is assumed there will not be a significant increase in staff time, and that this time can be covered by existing appropriations. Staff at the Public Service Commission and the Office of Energy will see an increase in staff time associated with issues surrounding bats and wind farms. These agencies will also see an increase in time associated with incidental permits. It is assumed there will not be a significant increase in staff's time at these agencies.
    Local fiscal estimate
    It is assumed there will be minimal cost increases to local governments as a result of this rule change. As an example of these minimal costs, local public works departments will need to distribute new local construction permits to include the listing of bats.
    Private entities fiscal impact
    It is assumed the Department will be issuing a broad incidental take permit associated with the listing. Many private companies such as pest control operators and construction companies will be covered under this broad incident take permit. The impact to wind farms will be determined by the location. Depending on the impact to bats, wind farms may be required to report damages to bats or to perform a determined mitigation.
    It is assumed the impact to farmers of this rule change will be positive; especially, in light of the fact that if bat populations in the state were to be devastated, the costs to agriculture from pest destruction and pesticide use would increase.
    State fiscal impact
    Indeterminate. Increase costs — May be possible to absorb within agency's budget.
    Local government fiscal impact
    Indeterminate. Increase costs — Permissive.
    Types of local governmental units affected
    Towns, Villages, Cities, Counties.
    Agency Contact Person
    Erin Crain
    Bureau of Endangered Resources
    P O Box 7921
    101 S. Webster Street, ER/6
    Madison, WI 53707-7921
    Phone: (608) 267-7479
    Notice of Hearing
    Natural Resources
    Fish, Game, Forestry, etc., Chs. NR 1—
    DNR # IS-42-10(E) and IS-41-10
    NOTICE IS HEREBY GIVEN that pursuant to ss. 23.09 (2) , 23.22 , 227.11 (2) and 227.24 , Stats., the Department of Natural Resources will hold public hearings on the proposed emergency and permanent rules to list the fungus, Geomyces destructans , as a prohibited invasive species in s. NR 40.04 (2) , Wis. Adm. Code. The hearings will be held concurrently with hearings to list four cave bat species as threatened in s. NR 27.03 (3) , Wis. Adm. Code.
    Hearing Information
    The hearings will begin at 11:00 am at the locations listed below. Following a brief informational presentation, public comments and statements will be accepted.
    October 25, 2010   Conference Room 1
      DNR Oshkosh Service Center
      625 E. County Rd. Y
      Oshkosh
    October 26, 2010   Glaciers Edge & Gathering Waters Rms.
      DNR South Central Region Hdqrs.
      3911 Fish Hatchery Road
      Fitchburg
    October 28, 2010   Room 185
      DNR West Central Region Hdqrs.
      1300 W. Clairemont
      Eau Claire
    October 29, 2010   Conference Room 1
      DNR Northern Region Headquarters
      107 Sutliff Avenue
      Rhinelander
    Pursuant to the Americans with Disabilities Act, reasonable accommodations, including the provision of informational material in an alternative format, will be provided for qualified individuals with disabilities upon request. Please call Ms. Rowe at (608)266-7012 with specific information on your request at least 10 days before the date of the scheduled hearing.
    Copies of Proposed Rules and Submittal of Written Comments
    The proposed rule and fiscal estimate may be reviewed and comments electronically submitted at the following Internet site: http://adminrules.wisconsin.gov . Written comments on the proposed rule may be submitted via U.S. mail to Ms. Stacy Rowe, Bureau of Endangered Resources, P.O. Box 7921, Madison, WI 53707 or by email to stacy.rowe@wisconsin.gov . Comments may be submitted until November 1, 2010 . Written comments whether submitted electronically or by U.S. mail will have the same weight and effect as oral statements presented at the public hearings. A personal copy of the proposed rule and fiscal estimate may be obtained from Ms. Rowe.
    Analysis Prepared by Department of Natural Resources
    Statutory authority
    Sections 23.09 (2) , 23.22 , 227.11 (2) and 227.24 , Stats.
    Plain language analysis
    The proposed changes to ch. NR 40 , Wis. Adm. Code, will add the fungus, Geomyces destructans , to the list of prohibited invasive species, allowing the department to effectively manage its spread and limit human transport.
    Existing rules ban the transportation (including importation), possession, transfer (including sale) and introduction of invasive species that are listed or identified as "prohibited", with certain exceptions. Transportation, possession, transfer and introduction without a permit are exempt if the department determines that the transportation, possession, transfer or introduction was incidental or unknowing, and was not due to the person's failure to take reasonable precautions. Existing rules authorize the department to enter property with the permission of the owner or person in control of the property and, if permission cannot be obtained, to seek an inspection warrant from the Circuit Court. Entry is only for the purpose of inspection, sampling or control of prohibited invasive species.
    The current rules also allow the department to enter into consent orders with persons who own, control or manage property where prohibited invasive species are present to implement approved control measures, and to issue unilateral orders for control purposes unless the person was not responsible for the presence of the prohibited invasive species. If a control order is not complied with and the department undertakes control measures, the current rules allow for cost-recovery by the department for the expenses it incurred.
    Related statute or rule
    Related statutes or rules include but are not limited to the following provisions which, to varying degrees, may apply to the identification, classification, control or other regulation of species that are invasive, or to conduct that may result in the introduction or spread of invasive species:
    Statutory section Title [or subject]
    15.347 (18)   Invasive species council.
    23.24   Aquatic plants.
    29.011   Title to wild animals.
    29.604   Endangered and threatened species
      protected.
    29.614   Scientific collector permit.
    29.885   Removal of wild animals.
    29.924   Investigations; Searches.
    30.07   Transportation of aquatic plants and animals;
      placement of objects in navigable waters.
    94.01   Plant inspection and pest control authority.
    94.02   Abatement of pests.
    94.03   Shipment of pests and biological control
      agents; permits.
    94.69   Pesticides; rules.
    169.04   Possession of live wild animals.
    169.06   Introduction, stocking, and release of wild
      animals.
    169.07   Exhibition of live wild animals.
    169.08   Propagation of wild animals.
    169.10   Sale and purchase of live wild animals.
    169.11   Harmful wild animals.
    Comparison with federal regulations
    We are not aware of any existing or proposed federal regulations that would list the fungus, Geomyces destructans , as an invasive species.
    Comparison with rules in adjacent states
    Wisconsin appears to be unique in taking the approach of listing the fungus, Geomyces destructans , as an invasive species; we are not aware of any other states or provinces that have taken similar actions. We don't know of any other states that have a similar mechanism—an invasive species rule— for listing the fungus. We are also not aware of any existing or proposed federal regulations that would list the fungus, Geomyces destructans , as an invasive species.
    Summary of factual data and analytical methodologies
    White-nose Syndrome (WNS) is a disease responsible for unprecedented mortality in cave hibernating bats and is identified by the white fungus ( Geomyces destructans ) that grows on the nose, ears, and muzzle and/or wing membrane. Infected bats exhibit atypical behavior, such as daytime activity during winter hibernation, which rapidly depletes stored energy reserves. Wing damage and emaciation are also common.
    WNS has been documented in fourteen states and two Canadian provinces, is spreading rapidly from the first affected sites (up to 800 miles per year). The speed at which WNS is spreading necessitates immediate action on the part of the department to list the white-nose fungus as a prohibited invasive species. Based on the current location and known rate of spread of the disease, it is likely that WNS will reach Wisconsin as early as January 2011.
    This rule was developed with the assistance of the Bureaus of Endangered Resources and Legal Services and with input from the Wisconsin Council on Invasive Species (Council). The Bureau of Endangered Resources prepared an Issue Brief for the Council, which provided background on white-nose syndrome, the extent and serious nature of the threat of the disease to Wisconsin's cave bats, and the need for listing Geomyces destructans as a prohibited invasive species.
    Analysis and supporting documents used to determine effect on small business
    Affected constituencies include commercial caves and mines, private cave and mine owners, recreational cavers, property owners, the agricultural industry, and the conservation community. Concerns will likely include how listing the fungus will affect current activities. Many of these potential concerns may be addressed through cost-sharing, technical support, and education provided by the department. Examples include: reviewing proposed research proposals and issuance of scientific research licenses, cost-sharing for installation of bat gates and other conservation actions, providing cave closure signage and decontamination protocols, and providing locations of caves that may be used for recreational caving activities (where bats are known to have been excluded).
    Under NR 40, the department may ask any person who owns, controls, or manages property where a prohibited species is present to control the prohibited species in accordance with a plan approved by the department. While a person who owns, controls or manages property where a prohibited species is present is responsible for controlling the prohibited species that exists on the property, the department will seek funds to assist in the control of prohibited species. Therefore, conducting control measures will not necessarily result in a cost to commercial cave operators. Additionally, commercial caves will have the option to exclude bats from their cave(s) with the help of the department, allowing them to remain open for tourism, and resulting in no loss of tourism dollars.
    Small Business Impact
    Pursuant to s. 227.114 , Stats., it is not anticipated that the proposed rule will have a significant economic impact on small businesses.
    Under s. 227.19 (3m) , Wis. Stats., a final regulatory flexibility analysis is not required.
    Small business regulatory coordinator
    The Department's Small Business Regulatory Coordinator may be contacted at SmallBusiness@dnr.state.wi.us or by calling (608) 266-1959.
    Environmental Impact
    The Department has made a preliminary determination that this action does not involve significant adverse environmental effects and does not need an environmental analysis under ch. NR 150 , Wis. Adm. Code. However, based on the comments received, the Department may prepare an environmental analysis before proceeding with the proposal. This environmental review document would summarize the Department's consideration of the impacts of the proposal and reasonable alternatives.
    Fiscal Estimate
    Assumptions used in arriving at fiscal estimate
    State government
    The proposed rule package will require time by DNR staff to prepare the rule and administer rule hearings. In addition, once the rule is implemented DNR staff time associated with NR 40 will require increased surveillance and treatment. It is assumed all of the increased time will be possible to absorb within the Department's current budget.
    Local government
    It is assumed there will be no increase in local government costs associated with this rule.
    Private entities
    Once the rule is implemented, there will be no costs to private land owners to follow invasives law. As with the existing law, if private land owners do not allow DNR on their land or if they intentionally move the invasive species, there will be an associated penalty cost if NR 40 is not followed.
    State fiscal effect
    Indeterminate. Increase Costs - May be possible to absorb within agency's budget.
    Local government fiscal effect
    None.
    Agency Contact
    Erin Crain
    Bureau of Endangered Resources
    P O Box 7921
    101 S. Webster Street, ER/6
    Madison, WI 53707-7921
    Phone: (608) 267-7479
    Notice of Hearing
    Natural Resources
    Environmental Protection — Water Supply,
    Chs. NR 800—
    DNR # DG-34-10
    NOTICE IS HEREBY GIVEN That pursuant to ss. 227.11 (2) (a) and 281.346 (4s) , (5) , and (9) , Stats., the Department of Natural Resources will hold public hearings on the creation of Chapter NR 860 — Water Use Permitting, relating to the application and permit process for withdrawals of water from the Great Lakes basin.
    Hearing Information
    The hearings will be held on:
    October 13, 2010   DNR Milwaukee SER Headquarters
    Wednesday   Rooms 140-141
    at 2:00 p.m.   2300 N. Dr. Martin Luther King Jr. Dr.
      Milwaukee, WI
    Concurrent sessions will be held at the following two locations:
    October 14, 2010   University of Wisconsin Green Bay
    Thursday   Instructional Services Bldg. Rm. 1034
    at 2:00 p.m.   2420 Nicolet Drive
      Green Bay, WI
    ( http://www.uwgb.edu/team/maps/index.htm#is1034
    October 14, 2010   Wis. Indianhead Tech. College (WITC)
    at 2:00 p.m.   Conference Center Room 306
      2100 Beaser Avenue
      Ashland, WI
    http://www.witc.edu/ashland/map.htm
    Pursuant to the Americans with Disabilities Act, reasonable accommodations, including the provision of informational material in an alternative format, will be provided for qualified individuals with disabilities upon request. Please call James McLimans at (608) 266-2726 with specific information on your request at least 10 days before the date of the scheduled hearing.
    Copies of Proposed Rules and Submittal of Written Comments
    The proposed rule and supporting documents, including the fiscal estimate, may be viewed and downloaded and comments electronically submitted at the following Internet site: http://adminrules.wisconsin.gov . (Search this Web site using the Natural Resources Board Order No. DG-34-10. Written comments on the proposed rule may be submitted via U.S. mail to Ms. Kristy Rogers, Bureau of Drinking Water and Groundwater, P.O. Box 7921, Madison, WI 53707 or by e-mail to Kristy.Rogers@wisconsin.gov . Comments may be submitted until October 31, 2010 . Written comments whether submitted electronically or by mail will have the same weight and effect as oral statements presented at the public hearings. If you do not have Internet access, a personal copy of the proposed rule and supporting documents may be obtained from Kristy Rogers, Bureau of Drinking Water and Groundwater, P.O. Box 7921, Madison, WI 53707 or by calling (608) 266-9254.
    Analysis Prepared by Department of Natural Resources
    Statute interpreted
    Section 281.346 ( 4m), (4s), (5), (5m), (6) and (9), Stats.
    Statutory authority
    Sections 227.11 (2) (a) and 281.346 (4s) , (5) , and (9) , Stats.
    Plain language analysis
    This rule supports the implementation of 2007 Wisconsin Act 227 and the Great Lakes—St. Lawrence River Basin Water Resources Compact (Compact) by defining the process, requirements, and criteria for water use permitting in the Great Lakes basin. Beginning on December 8, 2011, coverage under a general permit or an individual permit is required for all persons who withdraw water from the Great Lakes basin in an amount that averages 100,000 gallons per day or more in any 30-day period. The rule establishes definitions, permit application information requirements, permit review time limits, required permit conditions, criteria for permit issuance, procedures for amending and terminating permits, and standards and procedures for public participation for the water use permitting program.
    Summary of factual data and analytical methodologies
    Information from the Great Lakes-St. Lawrence River Basin Water Resources Council, other Great Lakes states, existing state statutes, and existing department rules and procedures were used to guide the development of the proposed rule.
    Comparison with federal regulations
    There are no comparable federal regulations pertaining to withdrawals of Great Lakes basin water.
    Comparison with rules in adjacent states
    The following table compares permitting requirements for water withdrawals in adjacent states.
    Wisconsin
    Michigan
    Illinois
    Iowa
    Minnesota
    A water use general permit is required for withdrawals from the Great Lakes basin that average 100,000 gallons per day or more in any 30 day period. A water use individual permit is required for withdrawals from the Great Lakes basin that equal at least 1,000,000 gallons per day for any 30 consecutive days.
    Permits are required for new and increased withdrawals of more than 2,000,000 gallons per day, new or increased withdrawals of more than 1,000,000 gallons per day if the withdrawal will have a certain type of impact (Zone C withdrawal), and new or increased intrabasin transfers of more than 100,000 gallons per day average over any 90-day period.
    An allocation permit is required for withdrawals from the Great Lakes basin.
    Water use permits are required of any person or entity that withdraws at least 25,000 gallons in a 24-hour period during any calendar year.
    Water use permits are required for withdrawals greater than or equal to 10,000 gallons per day or 1 million gallons per year from surface or groundwater.
    Analysis and supporting documents used to determine effect on small business
    The department lacks complete data on the number and nature of operations withdrawing water above the thresholds requiring a permit. However, based upon the withdrawal data that does exist (e.g. high capacity well pumpage data), most small businesses are expected to fall within the general permit category with very few needing to obtain an individual permit.
    Small Business Impact
    This rule will affect small businesses that supply their own water with water supply systems that withdraw an average of 100,000 gallons per day. Small businesses, like other entities that are affected by this rule, will have to obtain a permit, measure the amount of water used on a monthly basis, and report that water use annually. Small businesses that receive water solely from a public water supply will not be impacted by this rule. Most small businesses regulated by this rule are expected to fall within the general permit category. The general permit requirements are straightforward and can be accomplished by most individuals with no specific professional background. The application for an individual permit may require the hiring of a professional environmental consultant to assist with the evaluation of impacts from a proposed withdrawal.
    Pursuant to s. 227.114 , Stats., it is not anticipated that the proposed rules will have an economic impact on small businesses.
    Small business regulatory coordinator
    The Department's Small Business Regulatory Coordinator may be contacted at SmallBusiness@wisconsin.gov or by calling (608) 266-1959.
    Environmental Impact
    The Department has made a preliminary determination that this action does not involve significant adverse environmental effects and does not need an environmental analysis under ch. NR 150 , Wis. Adm. Code. However, based on the comments received, the Department may prepare an environmental analysis before proceeding with the proposal. This environmental review document would summarize the Department's consideration of the impacts of the proposal and reasonable alternatives.
    Fiscal Estimate
    A fiscal estimate has been prepared and a full copy can be obtained following the procedures set forth above. The rule is expected to have a minimal fiscal impact on existing withdrawers. New withdrawers and existing withdrawers that wish to increase their withdrawal will be required to apply for a permit. Preparation of the permit application may require the hiring of a consultant. The costs for a consultant will vary depending on the size of the withdrawal and potential impacts. There is little-to-no expected increase in annual costs for withdrawers. In most cases, the withdrawal measurement and annual reporting requirements are consistent with other existing Department requirements.
    Agency Contact Person
    Kristy J. Rogers, Water Supply Specialist
    Wisconsin Department of Natural Resources
    Bureau of Drinking Water & Groundwater
    Phone: (608) 266-9254