Wisconsin Legislature: CR 12-010

○ electronics - $1,000.

Some ski areas may need to replace signage to conform to the latest ANSI standard requirements. The typical cost of a sign is about $40. Signs are subject to weathering and most ski areas account for replacement in their operating budgets.

The department does not believe that the proposed rules will affect a significant number of existing ski hill operations.

Members of the advisory council are:

• Jim Engel, WI Ski Industries Association (WSIA)

• Sam Geise, Insurance Industry

• Hans Hauschild, WSIA

• Jim Hubing, National Ski Patrol System

• Don McKay, WSIA

• Gren Rudd, Ski Industry At Large

• Rick Schmitz, WSIA

• Dennis Schulz, Ski Industry At Large

• Chris Stoddard, Ski Industry At Large

• Rob Walz, WSIA

Initial Regulatory Flexibility Analysis

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

Businesses affected by the rules include those operations offering downhill skiing, snow boarding and/or tubing where access to the slopes and hills is provided by mechanical means, such as chair lift, surface lifts, rope tows or conveyor systems.

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

No new or addition bookkeeping or other administrative procedures are required for compliance.

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

No new or addition professional skills are required for compliance.

The small business regulatory coordinator for the Department of Safety and Professional Services is Greg Gasper, who may be contacted at telephone (608) 266-8608, or Email at greg.gasper@wisconsin.gov.

Environmental Analysis

Notice is hereby given that the department has considered the environmental impact of the proposed rules. In accordance with Chapter SPS 301, 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.

Agency Contact

James Quast, Program Manager,
jim.quast@wisconsin.gov, (608) 266-9292

STATE OF WISCONSIN DEPARTMENT OF ADMINISTRATION DOA 2049 (R 07/2011) ADMINISTRATIVE RULES FISCAL ESTIMATE AND ECONOMIC IMPACT ANALYSIS
Type of Estimate and Analysis
X Original Updated Corrected
Administrative Rule Chapter, Title and Number
Chapter SPS 333.
Subject
Passenger Ropeways
Fund Sources Affected			Chapter 20 , Stats. Appropriations Affected
GPR FED X PRO PRS SEG SEG-S
Fiscal Effect of Implementing the Rule
X No Fiscal Effect Indeterminate	Increase Existing Revenues Decrease Existing Revenues		Increase Costs Could Absorb Within Agency's Budget Decrease Costs
The Rule Will Impact the Following (Check All That Apply)
State's Economy Local Government Units		Specific Businesses/Sectors Public Utility Rate Payers
Would Implementation and Compliance Costs Be Greater Than $20 million? Yes X No
Policy Problem Addressed by the Rule
Under the authority of s. 101.17, Stats., the Department of Safety and Professional Services has oversight of various mechanical devices and equipment, which includes ski lifts and tows, in order to protect public safety. The current rules of Chapter SPS 333 require passenger ropeways to be designed, constructed, installed, maintained and operated in accordance with the 1999 edition of ANSI B77.1 standard Passenger Ropeways – Aerial Tramways, Aerial Lifts, Surface Lifts, Tows and Conveyors – Safety Requirements. The code was last updated in 2001. Since that time the ANSI standard has been revised twice, the 2011 being the current edition. The technical provisions of Chapter SPS 333 are out of date and no longer reflect current national standards.

Notice of Hearing

Safety and Professional Services

Controlled Substances Board

rulemaking_notices CR 12-010 CR 12-010

NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Controlled Substances Board in sections 227.11 (2) and 961.335 (8), Wis. Stats., and interpreting section 961.335, Wis. Stats., the Controlled Substances Board will hold a public hearing at the time and place indicated below to consider an order to promulgate Chapter CSB 3, Wis. Admin. Code. The proposed rules relate to the requirements and procedures for granting special use authorizations.

Hearing Information

Date: Monday, February 27, 2012

Time: 1:00 P.M.

Location: 1400 East Washington Avenue
Room 121
Madison, WI 53703

Appearances at the Hearing and Submittal of Written Comments

Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions, and argument in writing as well. Facts, opinions, and argument may also be submitted in writing without a personal appearance by mail addressed to the Department of Safety and Professional Services, Division of Board Services, P.O. Box 8935, Madison, Wisconsin 53708 or by email at Kristine1.Anderson@wisconsin.gov.. Written comments must be received at or before the public hearing to be included in the record of rule-making proceedings.

Copies of Rule

Copies of this proposed rule are available upon request to Kris Anderson, Paralegal, Department of Regulation and Licensing, Division of Board Services, 1400 East Washington Avenue, P.O. Box 8935, Madison, Wisconsin 53708, or by email at Kristine1.Anderson@wisconsin.gov.

Analysis Prepared by the Department of Safety and Professional Services

Statutes interpreted

Section 961.335, Stats.

Statutory authority

Sections 227.11 (2), 961.335 (8), Stats.

Explanation of agency authority

Section 227.11 (2), Stats., permits an agency to promulgate rules interpreting the provisions of any statute enforced or administered by the agency if the agency deems such rules necessary to effectuate the purposes of the statute. Section 961.335 (8), Stats., expressly authorizes the Wisconsin controlled substances board to promulgate rules relating to the board's issuance of special use authorization permits (SUA's), including rules regarding the criteria and procedures for obtaining SUA's, records retention and disclosure requirements for permit holders, submissions of protocols, and suspension or revocation of SUA's.

Related statute or rule

Sections 961.41, 961.42, and 941.43, Stats., establish Wisconsin's proscriptions against the unlawful manufacture, distribution, dispensing, delivery, or possession of any controlled substance. Section 961.335, Stats., provides for certain exceptions to those proscriptions. A search of Wisconsin's statutes and administrative code revealed only one reference to s. 961.335, the SUA statute, in s. 961.54 (3), Stats. Such reference is not related to the issuance of SUA's.

Plain language analysis

The proposed administrative code chapter will set forth rules for the issuance of SUA's by the controlled substances board. These rules will include definitions of terms used in the chapter; general requirements for SUA's; procedures and criteria for obtaining an initial permit and an amendment to an initial permit; limitations on drugs and drug quantities for use in training narcotics dogs; requirements for recordkeeping, records retention, and disclosure of records related to SUA's; and acts constituting violations of an SUA permit.

Summary of, and comparison with, existing or proposed federal regulation

The federal laws describing the requirements for manufacturers, distributors, and dispensers of controlled substances, Schedules I-V, are found at 21 U.S.C. ss. 821-830. All persons manufacturing, distributing, dispensing, or possessing for any purpose other than prescribed medical treatment, must obtain federal registration to do so. Id. The application requirements and procedures are set forth in the Code of the Federal Register at 21 C.F.R., Part 1301. There are 10 different categories of business activities, each of which requires separate registration: manufacturing; distributing; reverse distributing; dispensing or instructing; research – Sched. I; research – Sched.'s II-V; narcotic treatment program; importing; exporting; and chemical analysis. 21 C.F.R. s. 1301 (13). Those regulations comprise the federal equivalent of the “special use authorizations" referred to in the new administrative rules proposed herein.

Comparison with rules in adjacent states

Illinois:

Statutes: Under the Illinois Controlled Substances Act, all persons who manufacture, distribute, or dispense any controlled substance, or engage in chemical analysis or instructional activities using controlled substances, or who purchases, stores, or administers euthanasia drugs must obtain a registration issued by the Illinois Department of Financial and Professional Regulation. The Act requires the department to promulgate rules administering the registration function. Section 720 ILCS 570/301. Registered persons may possess, manufacture, distribute, or dispense controlled substances, or administer euthanasia drugs to the extent authorized by their registration and in conformity with the other provisions of the Act. Registration is site-specific, so persons operating at more than one site must have separate registration for each. Sections 720 ILCS 570/302 (a), (b), and (d). The department may deny, refuse to renew, suspend, or revoke a registration upon finding that the applicant or registrant has provided false information on an application, had his or her federal controlled substances registration suspended or revoked, been convicted of certain crimes, failed to take effective preventative measures against diversion, or violated any provision of the Illinois Controlled Substances Act or the Methamphetamine Precursor Control Act, or any of the rules promulgated under those Acts. Sections 720 ILCS 570/304 (a) and (b).
http://www.ilga.gov/legislation/ilcs/ilcs4.asp?DocName=072005700HArt%2E+III&ActID=1941&ChapterID=53&SeqStart=2600000&SeqEnd=5000000.

Administrative rules: The Illinois Administrative Code sets forth rules promulgated by the Department of Financial and Professional Regulation for implementing the provisions of the Controlled Substances Act. Title 77, ch. XV, pt. 3100, Ill. Admin. Code. Among other things, these rules require separate registrations for any of six different types of controlled substances activities deemed independent of each other. The independent-activities rule also describes several exceptions thereto. For instance, the first two of the different types of activities are 1) manufacturing controlled substances, and 2) distributing controlled substances. However, persons registered to manufacture a basic class of controlled substances, or one substance in particular, may distribute the same without a separate distribution registration. Sections 3100.50 a), b), Title 77, Ill. Admin. Code. Other rules provide instructions for registration applicants, and authorize the department to deny, limit, suspend, or revoke any registration upon finding the registrant in violation of any of the statutes or rules regarding controlled substances. Sections 3100.100, .160, Title 77, Ill. Admin. Code.
http://www.ilga.gov/commission/jcar/admincode/077/07703100sections.html.

Comparison of approaches: The Illinois laws regarding registration for use of controlled substances do not address “special uses" in a separate, or stand-alone, section as Wisconsin law does. Similar to Wisconsin though, the Illinois Controlled Substances Act includes a registration requirement, and charges a state agency with the administration of that requirement. The Illinois statutes and rules also contain provisions for certain non-medicinal-related uses that are substantially similar to the provisions of Wisconsin's special use authorization law, s. 961.335, Stats. One exception to the similarity is that, unlike the proposed Wisconsin rules, Illinois law does not specifically reference narcotic dog trainers in either its Controlled Substances Act or administrative code.

While Illinois's approach to controlled substances user registration differs in part from the approach taken by the Wisconsin controlled substances board's proposed rules, the fundamental policy of regulating uses of controlled substances not related to medical treatment is the same. Unlike Wisconsin's controlled substances law, the Illinois law is silent regarding the use of controlled substances for training narcotic dogs. That silence may cause confusion for persons using controlled substances for that purpose. Wisconsin's special use authorization statute provides for uses not specified in the statute by permitting the controlled substances board to approve “other special uses, without restriction because of enumeration." s. 961.335 (1), Stats. Accordingly, in addition to the special uses the Wisconsin statute does specify, the board's proposed rules address other “special," but well-known purposes, such as euthanasia at humane shelters or under municipal animal control laws, and the training of narcotic dogs. The board believes increased clarity will result in less confusion for both permit applicants and administrators.

Iowa:

Statutes: The Iowa statutes require that all persons who manufacture, distribute, or dispense any controlled substance, or who propose to engage in the manufacture, distribution, or dispensing of any controlled substance, obtain and maintain a biennial registration from the Iowa Board of Pharmacy. Registration applies to one site only, so persons operating at more than one site must have separate registrations for each. Registered persons may possess, manufacture, distribute, dispense, or conduct research using controlled substances to the extent authorized by their registration only and in conformity with the other provisions of Iowa's controlled substances registration law. Sections 124.302, 1., 2., 4., Iowa Code. The pharmacy board may suspend, revoke, or restrict a registration to manufacture, distribute, or dispense a controlled substance upon certain findings, including that the registrant has committed such acts as would render the registrant's registration inconsistent with the public interest as determined under s. 124.304 1.d., Iowa Code.
http://www.state.ia.us/ibpe/pdf/IC124.pdf

Administrative rules: Iowa's administrative code contains rules implementing the statutes regarding the use of controlled substances. The rules establish further specifications of who or what entities must register, and seven different types of activities, each of which requires separate registration. In addition, the rules include application instructions and procedures; specific requirements for the approved uses of controlled substances; descriptions of, and requirements for separate registrations of separate sites; requirements and procedures for modifying or terminating a current registration based on several different types of changes; and registration enforcement provisions. Beyond requiring “[m]anufacturers, distributors, reverse distributors, importers and exporters," of controlled substances to register, the list of persons and entities that must register includes all individual medical practitioners, pharmacies, hospitals, animal shelters, care facilities, researchers, dog trainers, analytical laboratories, and teaching institutions. Rules 657—10.1-.12, IAC.
http://www.legis.state.ia.us/aspx/ACODocs/ruleList.aspx?agency=657&chapter=10

Comparison of approaches: Like Illinois, and unlike Wisconsin, Iowa takes an approach to registration for controlled substances use that does not treat non-medicinal-related uses separately. Nevertheless, Iowa's controlled substances laws do require registration of persons using controlled substances for non-medicinal-related purposes, and charges a state agency with administering that requirement. Iowa sets forth comprehensive registration provisions in its administrative rules that are substantially similar to Wisconsin's special use authorization statute. In addition, the scope of Iowa's rules is more consistent with the Wisconsin board's proposed rules than not. Thus, Iowa's approach to administering its “special use" laws is essentially the same as the approach the Wisconsin controlled substances board contemplates in the instant rule-making proposal.

Michigan:

Statutes: Michigan's controlled substances law is set forth in that state's public health code, Act 368 of 1979, Art. 7. The statutes require any person who manufactures, distributes, prescribes, or dispenses a controlled substance in Michigan to obtain a license for such purposes issued by the Michigan Board of Pharmacy or its Administrator. Sections 333.7303, Art. 7, Michigan Compiled Laws (MCL). The administrator is authorized to promulgate rules for controlled substances licensure and the enforcement thereof. Section 333.7301, MCL. License holders may possess, manufacture, distribute, prescribe, dispense, or conduct research with the specified controlled substances to the extent authorized only, and as is consistent with all other provisions of Article 7. Licenses apply to specific sites, so persons operating at more than one site must have separate registrations for each. Persons licensed as pharmacists must also obtain a separate controlled substances license. Sections 333.7303 (1), (2), (5), MCL. The pharmacy board's disciplinary subcommittee may deny, limit, suspend, or revoke a license, or fine or reprimand a licensee, or order the licensee to perform community service or make restitution upon certain specified findings, including that the applicant or licensee has violated, or attempted to violate, any of the statutes in Article 7, or any of the rules promulgated thereunder. Section 333.7311 (1), MCL. The statutes require licensees to keep records of, and to annually inventory all stocked Schedule II-V controlled substances. Licensees must report their annual inventory to the Administrator. Section 333.7321 (2), MCL.
http://www.legislature.mi.gov/(S(nmvaaabic1r5tk45u0orwga0))/mileg.aspx?page=MclPASearch

Administrative rules: Michigan's administrative code specifies the particular type of activities a controlled substances license authorizes. There are six types of activities, and persons engaging in more than one type must obtain separate licenses for each. The list of activity types briefly describes the permissible practices under each license. Rules 338.3132 (1), Mich. Admin. Code. Other rules include provisions regarding the use of controlled substances for animal euthanasia, theft and diversion of controlled substances, storage, record-keeping obligations, and exceptions to the licensure requirement. Rules 338.3137 - .3143, and .3151 - .3153, Mich. Admin. Code.
http://www.state.mi.us/orr/emi/admincode.asp?AdminCode=Single&Admin_Num=33803101&Dpt=&RngHigh=33923405

Comparison of approaches: Similar to the controlled substances laws of Illinois, Iowa, and Wisconsin, Michigan's laws require that any person who uses controlled substances for purposes not related to medical treatment must obtain a license for such purposes from a state agency, in Michigan's case, the Michigan Board of Pharmacy. Unlike Illinois, Iowa, and Wisconsin, Michigan law compels licensed pharmacists to hold a separate license for the use of controlled substances within the scope of their practice. Moreover, Michigan's controlled substances statutes are far more comprehensive with respect to the licensing requirement than the Wisconsin special use authorization statute. The Michigan statutes contain many of the provisions that the Wisconsin controlled substances board proposes to codify as administrative rules. Michigan's approach to regulating controlled substances use thus differs significantly from Wisconsin's, and may ultimately be more onerous to its pharmacists than Wisconsin's approach.

Minnesota:

Statutes: Chapter 151, Minn. Stats., authorizes the Minnesota Board of Pharmacy to regulate the practice of pharmacy, the manufacture, wholesale, and retail sale of drugs within that state, and to license wholesale drug distributors. The pharmacy board is also charged with administering ch. 152, Minn. Stats., which regards scheduling and regulation of controlled substances. Section 152.02, subd. 7, Minn. Stats. Pursuant to s. 151.06, subds. 1. (a) (1), (2), (6), (7), (10), 1. (c), Minn. Stats., the board must promulgate uniform rules for carrying out and enforcing the governing statutes. The statutes require the board to register, on an annual basis, every person engaged in manufacturing drugs, medicines, chemicals, or poisons for medicinal purposes. Section 151.25, Minn Stats. The Minnesota pharmacy and controlled substances statutes do not specifically address uses that are not directly or indirectly related to medical treatment of patients. The pharmacy board may deny, suspend, revoke, or refuse to renew any required registration or license on grounds such as fraud or deception in securing a registration or license, unprofessional conduct or conduct endangering public health, and gross immorality. https://www.revisor.mn.gov/statutes/?id=151

Administrative rules: Chapter 6800 of Minnesota's administrative code pertains to the state's board of pharmacy and its oversight of pharmacists and pharmacies. The code provides for four general types of licenses: pharmacists, pharmacies, drug manufacturers and wholesalers, and controlled substances researchers. Any person engaging in research, teaching, or educational projects involving the use of controlled substances must obtain registration for these uses, renewable annually, from the board. Section 6800.4400, subp. 1., Minn. Admin. Code. Registration requires that the registrant have policies and procedures for effective controls against theft and diversion of all stocked inventory, unauthorized access, substance waste, and returns. Further, registrants must maintain adequate records showing purchases and purchase receipts, use, transfer, and disposal of the controlled substances specified in the registration. To track the effectiveness of the required controls, registrants must inventory stocked controlled substances annually. Section 6800.4400, subpt. 3., Minn. Admin. Code. Disciplinary proceedings against any pharmacy board licensee or registrant are governed by ss. 6800.9100 - .9700, Minn. Admin. Code.
https://www.revisor.mn.gov/rules/?id=6800

Comparison of approaches: By administrative rule, Minnesota registers persons using controlled substances for research or instructional purposes separately from pharmacists and pharmacies. Minnesota's approach to regulating non-medicinal-related uses is, in that sense, similar to Wisconsin's. However, unlike Wisconsin, neither Minnesota's pharmacy or controlled substances statutes, nor its administrative rules address the use of controlled substances in humane shelters or for training narcotic dogs. Moreover, the law regarding research or educational use of controlled substances appears only in Minnesota's administrative code, and not in its statutes. The administrative rule specific to such uses references only persons involved in research or teaching. Finally, the enforcement procedures applicable to alternative use registration are subsumed within the pharmacy board's general enforcement authority, rather than set forth within the context of research or teaching use registration.

Minnesota's rules on controlled substances licensure thus appear to provide very little guidance to persons involved in research or teaching activities. For instance, there are no rules establishing the precise requirements and procedures for registration applications or record-keeping, and none defining violations warranting disciplinary action. The absence of such written requirements and procedures would seem to promote a lack of clarity, and generate numerous inquiries from applicants and current registrants. Inadequate clarity with respect to registration requirements and procedures could also permit more challenges to board decisions on registration issues than may otherwise occur. The rules proposed by the Wisconsin controlled substances board would serve to avoid such potentialities, and in doing so, conserve scarce state resources.

Summary of factual data and analytical methodologies

These proposed rules are for the purpose of clarifying the requirements and procedures regarding SUA permits for both applicants and the controlled substances board, and to establish procedures for the enforcement of an SUA's terms when violations occur. Under s. 961.335 (8), the board “may promulgate rules relating to the granting of special use permits…and suspension or revocation of permits." Pursuant to s. 227.23, Stats., following the enactment of s. 961.335, the board created various forms outlining SUA requirements and procedures. However, the controlled substances board currently has no clear rules covering the enforcement aspect of its authority under s. 961.335. Thus, these proposed rules will not only more clearly delineate the statutory requirements and the administrative procedures for obtaining and amending an SUA, it will also define those actions or the lack thereof that will result in permit suspension or revocation. As these new rules are necessary for both of such purposes, the board had no need to review empirical factual data, nor did it require the use of analytical methodologies in the drafting of this proposal.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact report

Pursuant to s. IV, 3. a., EO # 50, the rules proposed herein were posted on both the state's and the department's administrative rules websites for 14 days to solicit comments regarding the rule's potential economic impact on businesses, business sectors, professional associations, local government units, or potentially interested parties. In addition, e-mails solicitations were sent to several potentially interested parties. No responses to any of the solicitations were received. The economic impact analysis is attached hereto.

Moreover, this proposal constitutes the first implementation of s. 961.335, Stats., the special permit authorization statute, by the Controlled Substances Board. Because the statutory requirements have been in place for several years, any economic or fiscal impact experienced by private businesses or public entities that may have resulted from the enactment of s. 961.335, Stats., has already been absorbed by such entities as a part of routine operations.

Anticipated costs incurred by private sector

The department finds that this rule should have no significant fiscal effect on the private sector.

Fiscal estimate

The department estimates that these proposed rules will have no significant fiscal impact.

Effect on Small Business

The department concludes that the proposed rules will have no economic impact on small businesses. This proposal tracks legislation that has been in effect for several years. The department's Regulatory Review Coordinator may be contacted by email at Greg.Gasper@Wisconsin.gov, or by calling 608-266-8608.

Initial Regulatory Flexibility Analysis or Summary

These proposed rules will affect small businesses that employ persons who use controlled substances for non-medicinal-related purposes in the course of their employment. Such businesses would include, but are not limited to, those conducting scientific research, instructional activities, chemical analysis, drug-detecting animal training, and humane shelters. Special use authorization permits authorize only the uses and amounts of substances specified in the permit. Deviations require an amended permit. Permits must be renewed annually. Persons holding special use authorization will be required to keep current and accurate records of (a) all purchases of controlled substances authorized under a permit; (b) all disbursements, uses, and dispositions of such controlled substances; (c) the total weight of each authorized controlled substance; and (d) inventory discrepancies and investigations thereof. Applying for, and maintaining, a special use authorization permit will require knowledge of the purposes for, substances, and amounts requested. Completing applications, and keeping records could be delegated to clerical personnel by transmitting the required information to clerical staff.

Agency Contact Person

Kris Anderson, Department of Safety and Professional Services, Division of Board Services, 1400 E. Washington Ave., Room 116, P.O. Box 8935, Madison, Wisconsin 53708; telephone: 608-261-2385;
e-mail: Kristine1.Anderson@Wisconsin.gov.

STATE OF WISCONSIN DEPARTMENT OF ADMINISTRATION DOA 2049 (R 07/2011) ADMINISTRATIVE RULES FISCAL ESTIMATE AND ECONOMIC IMPACT ANALYSIS
Type of Estimate and Analysis
X Original Updated Corrected
Administrative Rule Chapter, Title and Number
Chapter CSB 3, Special Use Authorization Permits (creating chapter)
Subject
Authorization from the controlled substances board for non-medicinal uses of controlled substances
Fund Sources Affected			Chapter 20 , Stats. Appropriations Affected
GPR FED PRO PRS SEG SEG-S
Fiscal Effect of Implementing the Rule
X No Fiscal Effect Indeterminate	Increase Existing Revenues Decrease Existing Revenues		Increase Costs Could Absorb Within Agency's Budget Decrease Costs
The Rule Will Impact the Following (Check All That Apply)
State's Economy Local Government Units		X Specific Businesses/Sectors Public Utility Rate Payers
Would Implementation and Compliance Costs Be Greater Than $20 million? Yes X No
Policy Problem Addressed by the Rule
Under s. 961.335, Wis. Stats., the controlled substances board has the discretion to issue permits to persons who manufacture, possess, use, administer, or dispense controlled substances for non-medical purposes. Such purposes include scientific research, instructional activities, chemical analysis, and other special uses as approved by the board. The proposed rules will define the procedures associated with the board's exercise of its permitting authority, as allowed under s. 961.335 (9), Stats. In addition, under the authority granted by the statute, the board in these rules will set forth the acts constituting violations of a special use authorization permit, as well as the potential discipline the board may impose upon a finding of a violation.
Summary of Rule's Economic and Fiscal Impact on Specific Businesses, Business Sectors, Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole (Include Implementation and Compliance Costs Expected to be Incurred)
These proposed rules track legislation that has been in effect for several years. Any economic or fiscal impact experienced by private businesses or public entities due to the creation of s. 961.335, Stats., has long since been absorbed by such businesses and entities as a part of routine operations. The rules promulgated by this proposal will therefore have no current economic or fiscal impact on any of those entities.
Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
The specification of acts constituting violations of special use authorization permits will provide permit holders and enforcement staff clearer notice of the acts that will garner board discipline. This will facilitate the board's ability to protect the public from injury caused by unlawful uses of such permits.
Long Range Implications of Implementing the Rule
Increased public safety through improved board oversight of the actions of permit holders, and decreased violations of permit provisions, both specific and general.
Compare With Approaches Being Used by Federal Government
The federal Controlled Substances Act, codified at ss. 21 U.S.C. 801- 971, is administered by the United States Department of Justice and its Drug Enforcement Administration (DEA). Subchapter I, pt. C of the those statutes contains comprehensive legislation for regulating the use of controlled substances, including a requirement that all persons using controlled substances for any purpose must obtain a registration from the U.S. attorney general. Sections 21 U.S.C. 821-831. The federal statutory registration requirements have served as a model for several of the states' versions of their controlled substances registration laws, whether in their statutes or administrative rules, either or both of which contain provisions substantially similar to those of the federal law. The DEA's rules regarding controlled substances registration are set forth at ss. 21 C.F.R. 1300-1399. It appears that the approach to registration for use of controlled substances in the Wisconsin statutes, and the approach taken by the Wisconsin controlled substances board in its rule-making proposal, is also substantially similar to the federal government's approach. Like several of the states neighboring Wisconsin though, the federal government does not separate registrations for non-medicinal-related uses from any other types of registration. That is because the federal government's regulation requirement applies to all persons using controlled substances in the course of their work, regardless whether they hold a state license or registration for use of controlled substances.
Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota)
Illinois: Statutes: Under the Illinois Controlled Substances Act, all persons who manufacture, distribute, or dispense any controlled substance, or engage in chemical analysis or instructional activities using controlled substances, or who purchases, stores, or administers euthanasia drugs must obtain a registration issued by the Illinois Department of Financial and Professional Regulation. The Act requires the department to promulgate rules administering the registration function. Section 720 ILCS 570/301. Registered persons may possess, manufacture, distribute, or dispense controlled substances, or administer euthanasia drugs to the extent authorized by their registration and in conformity with the other provisions of the Act. Registration is site-specific, so persons operating at more than one site must have separate registration for each. Sections 720 ILCS 570/302 (a), (b), and (d). The department may deny, refuse to renew, suspend, or revoke a registration upon finding that the applicant or registrant has provided false information on an application, had his or her federal controlled substances registration suspended or revoked, been convicted of certain crimes, failed to take effective preventative measures against diversion, or violated any provision of the Illinois Controlled Substances Act or the Methamphetamine Precursor Control Act, or any of the rules promulgated under those Acts. Sections 720 ILCS 570/304 (a) and (b). http://www.ilga.gov/legislation/ilcs/ilcs4.asp?DocName=072005700HArt%2E+III&ActID=1941&ChapterID=53&SeqStart=2600000&SeqEnd=5000000. Administrative rules: The Illinois Administrative Code sets forth rules promulgated by the Department of Financial and Professional Regulation for implementing the provisions of the Controlled Substances Act. Title 77, ch. XV, pt. 3100, Ill. Admin. Code. Among other things, these rules require separate registrations for any of six different types of controlled substances activities deemed independent of each other. The independent-activities rule also describes several exceptions thereto. For instance, the first two of the different types of activities are 1) manufacturing controlled substances, and 2) distributing controlled substances. However, persons registered to manufacture a basic class of controlled substances, or one substance in particular, may distribute the same without a separate distribution registration. Sections 3100.50 a), b), Title 77, Ill. Admin. Code. Other rules provide instructions for registration applicants, and authorize the department to deny, limit, suspend, or revoke any registration upon finding the registrant in violation of any of the statutes or rules regarding controlled substances. Sections 3100.100, .160, Title 77, Ill. Admin. Code. http://www.ilga.gov/commission/jcar/admincode/077/07703100sections.html. Comparison of approaches: The Illinois laws regarding registration for use of controlled substances do not address “special uses" in a separate, or stand-alone, section as Wisconsin law does. Similar to Wisconsin though, the Illinois Controlled Substances Act includes a registration requirement, and charges a state agency with the administration of that requirement. The Illinois statutes and rules also contain provisions for certain non-medicinal-related uses that are substantially similar to the provisions of Wisconsin's special use authorization law, s. 961.335, Stats. One exception to the similarity is that, unlike the proposed Wisconsin rules, Illinois law does not specifically reference narcotic dog trainers in either its Controlled Substances Act or administrative code. While Illinois's approach to controlled substances user registration differs in part from the approach taken by the Wisconsin controlled substances board's proposed rules, the fundamental policy of regulating uses of controlled substances not related to medical treatment is the same. Unlike Wisconsin's controlled substances law, the Illinois law is silent regarding the use of controlled substances for training narcotic dogs. That silence may cause confusion for persons using controlled substances for that purpose. Wisconsin's special use authorization statute provides for uses not specified in the statute by permitting the controlled substances board to approve “other special uses, without restriction because of enumeration." s. 961.335 (1), Stats. Accordingly, in addition to the special uses the Wisconsin statute does specify, the board's proposed rules address other “special," but well-known purposes, such as euthanasia at humane shelters or under municipal animal control laws, and the training of narcotic dogs. The board believes increased clarity will result in less confusion for both permit applicants and administrators. Iowa: Statutes: The Iowa statutes require that all persons who manufacture, distribute, or dispense any controlled substance, or who propose to engage in the manufacture, distribution, or dispensing of any controlled substance, obtain and maintain a biennial registration from the Iowa Board of Pharmacy. Registration applies to one site only, so persons operating at more than one site must have separate registrations for each. Registered persons may possess, manufacture, distribute, dispense, or conduct research using controlled substances to the extent authorized by their registration only and in conformity with the other provisions of Iowa's controlled substances registration law. Sections 124.302, 1., 2., 4., Iowa Code. The pharmacy board may suspend, revoke, or restrict a registration to manufacture, distribute, or dispense a controlled substance upon certain findings, including that the registrant has committed such acts as would render the registrant's registration inconsistent with the public interest as determined under s. 124.304 1.d., Iowa Code. http://www.state.ia.us/ibpe/pdf/IC124.pdf