Title 040 | Chapter 012 | Regulation 440REG
PROPOSED
This document is not yet current.
OFFICE OF ATTORNEY GENERAL
Kentucky Office of Regulatory Relief
(New Administrative Regulation)
40 KAR 12:440.Health spas.
Section 1.
Health Spa Registration Statement Application.(1)
The Attorney General must approve a health spa's registration application before a health spa may offer health spa services or facilities at a specific location in the Commonwealth of Kentucky. A health spa shall complete and submit a Health Spa Registration Statement Application, Form HS-1, to the Attorney General's office, and submit:(a)
Payment of the $100 registration fee;(b)
The applicant's certificate of existence, authorization certificate from the Kentucky Secretary of State's office, or other evidence of the applicant's authority to transact business in Kentucky; and(c)
Unless exempted by KRS 367.906(4), a completed Health Spa Surety Bond, Form HS-3.(2)
Applicants shall complete or submit additional information or documents for their application within thirty (30) days of any request by the Attorney General. The Attorney General may deny any application if an applicant fails to timely complete the application by not paying the application fee or not providing requested missing information or required documents.Section 2.
Health Spa Renewal Application.(1)
Health Spa Registrations are valid for a one (1) year period from July 1 to June 30th of the following year.(2)
On or before June 1st of a current registration year, a registered health spa may renew its registration by completing and submitting a Health Spa Registration Renewal Application, Form HS-2, to the Attorney General's office on or before June 1st of a current registration year, and submitting:(a)
Payment of the fifty (50) dollar registration renewal fee; and(b)
Unless exempted by KRS 367.906(4), a completed Health Spa Surety Bond, Form HS-3, when a prior filed bond is not current or the bond amount is insufficient.(3)
Applicants shall complete or submit additional information or documents for their application within thirty (30) days of any request by the Attorney General. The Attorney General may deny any renewal application if an applicant fails to timely complete the application by not paying the renewal application fee or provide requested missing information or required documents.Section 3.
Written Notification of Material Changes. A registered health spa shall notify the Attorney General, in writing, within fourteen (14) days of any material change to information provided in the registrant's original application, any renewal application, or application attachments.Section 4.
Record Requests. A health spa shall make requested records, documents and information readily available to the Attorney General for inspection and copying upon request.Section 5.
Incorporation by Reference.(1)
The following materials are incorporated by reference:(a)
"Health Spa Registration Application", Form HS-1, Nov. 2025;(b)
"Health Spa Registration Renewal Application", Form HS-2, Nov. 2025;(c)
"Health Spa Surety Bond", Form HS-3, Nov. 2025;(2)
This material may be inspected, copied, or obtained, subject to applicable copyright law, at Office of the Attorney General Capital Complex East, 1024 Capital Center Drive, Suite 200, Frankfort, Kentucky 40601, Monday through Friday, between the hours of 8:00 a.m. and 4:30 p.m. This material is also available on the Attorney General's website, https://ag.ky.gov/Pages/default.aspx.STEPHEN B. HUMPHRESS, Executive Director
RUSSELL COLEMAN, Attorney General
APPROVED BY AGENCY: November 13, 2025
FILED WITH LRC: November 13, 2025 at 3:00 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this proposed administrative regulation shall be held on January 27, 2026, at 10:30 a.m. Eastern Time at the Kentucky Office of Attorney General, Office of Consumer Protection, 1024 Capital Center Drive, Room A, Frankfort, Kentucky 40601. Individuals interested in being heard at this hearing shall notify this Office in writing at least five (5) working days prior to the hearing of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who wishes to be heard will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on the proposed administrative regulation. Written comments shall be accepted through 11:59 p.m. on January 31, 2025. Send written notification of intent to be heard at the public hearing or written comments on the proposed administrative regulation to the contact person.
CONTACT PERSON: Stephen B. Humphress, Executive Director, Kentucky Office of Regulatory Relief, Kentucky Office of Attorney General, 1024 Capital Center Drive, Suite 200, Frankfort, Kentucky 40601, phone 502-696-5408, fax (502) 573-8317, email steve.humphress@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Stephen B. Humphress
Subject Headings:
Attorney General; Occupations and Professions; and Bonds
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes a registration statement application form, a registration renewal application form and surety bond form to be used by health spas.
(b) The necessity of this administrative regulation:
This regulation is necessary since it allows the Office of Attorney General, Kentucky Office of Regulatory Relief ("Attorney General") to perform its statutory mandates.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
KRS 15.180 directs the Attorney General to promulgate administrative regulations that will facilitate the performance of duties vested in the Attorney General and the Department of Law by law. KRS 367.150(4) requires the Department of Law to study the operation of all laws, rules, administrative regulations, orders, and state policies affecting consumers and to recommend administrative regulations in the consumers' interest. KRS 367.905 requires a health spa to file registration application statement and a renewal application statement to the Attorney General. KRS 367.906 requires the Attorney General to establish a surety bond form to be used by health spas.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation establishes the registration application form, registration renewal form, and surety bond form to be used by health spas.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
Not Applicable
(b) The necessity of the amendment to this administrative regulation:
Not Applicable
(c) How the amendment conforms to the content of the authorizing statutes:
Not Applicable
(d) How the amendment will assist in the effective administration of the statutes:
Not Applicable
(3) Does this administrative regulation or amendment implement legislation from the previous five years?
No
(4) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
This regulation amendment affects 184 registered health spas, approximately 15 new health spa applicants each year, and the Attorney General.
(5) Provide an analysis of how the entities identified in question (4) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (4) will have to take to comply with this administrative regulation or amendment:
Registered and new health spas will be required to use the new forms incorporated into this regulation. The Attorney General will review the completed forms for compliance with law.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (4):
Registered and new health spas will have no additional costs. They will be able to download the forms from the Attorney General’s website at no cost. The Attorney General will have no additional costs.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (4):
The regulation and forms allow health spas to register and renew registrations easily and the Attorney General to process registrations and renewals without difficulty.
(6) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
There are no costs to implement this administrative regulation.
(b) On a continuing basis:
There are no continuing costs to implement this administrative regulation.
(7) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation or this amendment:
There are no additional costs associated with implementing this administrative regulation.
(8) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
There is no anticipated fee increases or funding necessary for this administrative regulation.
(9) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This administrative regulation does not directly or indirectly establish or increase any fees.
(10) TIERING: Is tiering applied?
No.
FISCAL IMPACT STATEMENT
(1) Identify each state statute, federal statute, or federal regulation that requires or authorizes the action taken by the administrative regulation:
KRS 15.180, 367.150(4), 367.480, 367.484(5)
(2) State whether this administrative regulation is expressly authorized by an act of the General Assembly, and if so, identify the act:
(2) State whether this administrative regulation is expressly authorized by an act of the General Assembly, and is so, identify the act: 1960 Ky. Acts ch. 68, Art. II, sec. 1, effective March 17, 1960; 1972 Ky. Acts ch. 4, sec. 4; and 1988 Ky. Acts ch. 367, sec. 1, effective July 15, 1988.
(3)(a) Identify the promulgating agency and any other affected state units, parts, or divisions:
The Office of Attorney General, Kentucky Office of Regulatory Relief ("Attorney General") is the promulgating agency. The regulation does not affect any other state agencies. (b) Estimate the following for each affected state unit, part, or division in (3)(a):
(b) Estimate the following for each affected state unit, part, or division identified in (3)(a):
1. Expenditures:
For the first year:
There are no expenditures to administer this administrative regulation for the first year.
For subsequent years:
There will be no expenditures to administer the administrative regulation in subsequent years.
2. Revenues:
For the first year:
The administrative regulation will generate no revenues to the Attorney General in the first year. Registration fees referenced in the regulation are established by statute.
For subsequent years:
The administrative regulation will generate no revenues to the Attorney General in subsequent years. Registration fees referenced in the regulation are established by statute.
3. Cost Savings:
For the first year:
In the first year, the Attorney General will have cost savings from efficient and quicker processing of applications which are difficult to estimate at this time but estimated to be de minimis.
For subsequent years:
In subsequent years, the Attorney General will have cost savings from efficient and quicker processing of applications which are difficult to estimate at this time but estimated to be de minimis.
(4)(a) Identify affected local entities (for example: cities, counties, fire departments, school districts):
The administrative regulation will not affect any local entities.
(b) Estimate the following for each affected local entity identified in (4)(a):
1. Expenditures:
For the first year:
This administrative regulation will not cause expenditures by local entities for the first year.
For subsequent years:
This administrative regulation will not cause expenditures by local entities in subsequent years.
2. Revenues:
For the first year:
Local entities will receive no revenues from this administrative regulation for the first year.
For subsequent years:
Local entities will receive no revenues from this administrative regulation in subsequent years.
3. Cost Savings:
For the first year:
Local entities will receive no cost savings from this administrative regulation for the first year.
For subsequent years:
Local entities will receive no cost savings from this administrative regulation for subsequent years.
(5)(a) Identify any affected regulated entities not listed in (3)(a) or (4)(a):
Health spas will be affected by this administrative regulation will be affected by this administrative regulation.
(b) Estimate the following for each regulated entity identified in (5)(a):
1. Expenditures:
For the first year:
This administrative regulation will not cause health spas to have any additional expenditures for the first year.
For subsequent years:
This administrative regulation will not cause health spas to have any additional expenditures for subsequent years.
2. Revenues:
For the first year:
Health spas will not receive any revenues directly from this administrative regulation for the first year.
For subsequent years:
Health spas will not receive any revenues directly from this administrative regulation for subsequent years.
3. Cost Savings:
For the first year:
For the first year, health spas will receive cost savings from quicker processing of applications. These cost savings are difficult to estimate at this time but estimated to be de minimis.
For subsequent years:
For subsequent years, health spas will receive cost savings from quicker processing of applications. These cost savings are difficult to estimate at this time but estimated to be de minimis.
(6) Provide a narrative to explain the following for each entity identified in (3)(a), (4)(a), and (5)(a)
(a) Fiscal impact of this administrative regulation:
This administrative regulation will have no fiscal impact. The new regulation merely creates a registration application form, renewal application form, and surety bond form for use by health spas. The regulation does not affect any other governmental agencies or local governments. The regulation does not establish any fees. For these reasons, the regulation is not expected to have any significant fiscal impact.
(b) Methodology and resources used to reach this conclusion:
The Attorney General used a quantitative methodology analysis based on history of administrative agencies which license or register businesses in a specific subject area and the resulting facts from this regulation. The Attorney General used staff resources in determining the fiscal impact.
(7) Explain, as it relates to the entities identified in (3)(a), (4)(a), and (5)(a):
(a) Whether this administrative regulation will have a "major economic impact", as defined by KRS 13A.010(14):
There is not an expected "major economic impact" from this regulation for the Attorney General, any local entities, or affected regulated entities.
(b) The methodology and resources used to reach this conclusion:
The Attorney General used a quantitative methodology analysis based on history of administrative agencies which license or register businesses in a specific subject area and resulting facts from this regulation. The Attorney General used staff resources in reaching the conclusion that no overall negative or adverse major economic impact results from this administrative regulation.
OFFICE OF ATTORNEY GENERAL
Kentucky Office of Regulatory Relief
(New Administrative Regulation)
40 KAR 12:440.Health spas.
Section 1.
Health Spa Registration Statement Application.(1)
The Attorney General must approve a health spa's registration application before a health spa may offer health spa services or facilities at a specific location in the Commonwealth of Kentucky. A health spa shall complete and submit a Health Spa Registration Statement Application, Form HS-1, to the Attorney General's office, and submit:(a)
Payment of the $100 registration fee;(b)
The applicant's certificate of existence, authorization certificate from the Kentucky Secretary of State's office, or other evidence of the applicant's authority to transact business in Kentucky; and(c)
Unless exempted by KRS 367.906(4), a completed Health Spa Surety Bond, Form HS-3.(2)
Applicants shall complete or submit additional information or documents for their application within thirty (30) days of any request by the Attorney General. The Attorney General may deny any application if an applicant fails to timely complete the application by not paying the application fee or not providing requested missing information or required documents.Section 2.
Health Spa Renewal Application.(1)
Health Spa Registrations are valid for a one (1) year period from July 1 to June 30th of the following year.(2)
On or before June 1st of a current registration year, a registered health spa may renew its registration by completing and submitting a Health Spa Registration Renewal Application, Form HS-2, to the Attorney General's office on or before June 1st of a current registration year, and submitting:(a)
Payment of the fifty (50) dollar registration renewal fee; and(b)
Unless exempted by KRS 367.906(4), a completed Health Spa Surety Bond, Form HS-3, when a prior filed bond is not current or the bond amount is insufficient.(3)
Applicants shall complete or submit additional information or documents for their application within thirty (30) days of any request by the Attorney General. The Attorney General may deny any renewal application if an applicant fails to timely complete the application by not paying the renewal application fee or provide requested missing information or required documents.Section 3.
Written Notification of Material Changes. A registered health spa shall notify the Attorney General, in writing, within fourteen (14) days of any material change to information provided in the registrant's original application, any renewal application, or application attachments.Section 4.
Record Requests. A health spa shall make requested records, documents and information readily available to the Attorney General for inspection and copying upon request.Section 5.
Incorporation by Reference.(1)
The following materials are incorporated by reference:(a)
"Health Spa Registration Application", Form HS-1, Nov. 2025;(b)
"Health Spa Registration Renewal Application", Form HS-2, Nov. 2025;(c)
"Health Spa Surety Bond", Form HS-3, Nov. 2025;(2)
This material may be inspected, copied, or obtained, subject to applicable copyright law, at Office of the Attorney General Capital Complex East, 1024 Capital Center Drive, Suite 200, Frankfort, Kentucky 40601, Monday through Friday, between the hours of 8:00 a.m. and 4:30 p.m. This material is also available on the Attorney General's website, https://ag.ky.gov/Pages/default.aspx.STEPHEN B. HUMPHRESS, Executive Director
RUSSELL COLEMAN, Attorney General
APPROVED BY AGENCY: November 13, 2025
FILED WITH LRC: November 13, 2025 at 3:00 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this proposed administrative regulation shall be held on January 27, 2026, at 10:30 a.m. Eastern Time at the Kentucky Office of Attorney General, Office of Consumer Protection, 1024 Capital Center Drive, Room A, Frankfort, Kentucky 40601. Individuals interested in being heard at this hearing shall notify this Office in writing at least five (5) working days prior to the hearing of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who wishes to be heard will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on the proposed administrative regulation. Written comments shall be accepted through 11:59 p.m. on January 31, 2025. Send written notification of intent to be heard at the public hearing or written comments on the proposed administrative regulation to the contact person.
CONTACT PERSON: Stephen B. Humphress, Executive Director, Kentucky Office of Regulatory Relief, Kentucky Office of Attorney General, 1024 Capital Center Drive, Suite 200, Frankfort, Kentucky 40601, phone 502-696-5408, fax (502) 573-8317, email steve.humphress@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Stephen B. Humphress
Subject Headings:
Attorney General; Occupations and Professions; and Bonds
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes a registration statement application form, a registration renewal application form and surety bond form to be used by health spas.
(b) The necessity of this administrative regulation:
This regulation is necessary since it allows the Office of Attorney General, Kentucky Office of Regulatory Relief ("Attorney General") to perform its statutory mandates.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
KRS 15.180 directs the Attorney General to promulgate administrative regulations that will facilitate the performance of duties vested in the Attorney General and the Department of Law by law. KRS 367.150(4) requires the Department of Law to study the operation of all laws, rules, administrative regulations, orders, and state policies affecting consumers and to recommend administrative regulations in the consumers' interest. KRS 367.905 requires a health spa to file registration application statement and a renewal application statement to the Attorney General. KRS 367.906 requires the Attorney General to establish a surety bond form to be used by health spas.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation establishes the registration application form, registration renewal form, and surety bond form to be used by health spas.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
Not Applicable
(b) The necessity of the amendment to this administrative regulation:
Not Applicable
(c) How the amendment conforms to the content of the authorizing statutes:
Not Applicable
(d) How the amendment will assist in the effective administration of the statutes:
Not Applicable
(3) Does this administrative regulation or amendment implement legislation from the previous five years?
No
(4) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
This regulation amendment affects 184 registered health spas, approximately 15 new health spa applicants each year, and the Attorney General.
(5) Provide an analysis of how the entities identified in question (4) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (4) will have to take to comply with this administrative regulation or amendment:
Registered and new health spas will be required to use the new forms incorporated into this regulation. The Attorney General will review the completed forms for compliance with law.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (4):
Registered and new health spas will have no additional costs. They will be able to download the forms from the Attorney General’s website at no cost. The Attorney General will have no additional costs.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (4):
The regulation and forms allow health spas to register and renew registrations easily and the Attorney General to process registrations and renewals without difficulty.
(6) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
There are no costs to implement this administrative regulation.
(b) On a continuing basis:
There are no continuing costs to implement this administrative regulation.
(7) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation or this amendment:
There are no additional costs associated with implementing this administrative regulation.
(8) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
There is no anticipated fee increases or funding necessary for this administrative regulation.
(9) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This administrative regulation does not directly or indirectly establish or increase any fees.
(10) TIERING: Is tiering applied?
No.
FISCAL IMPACT STATEMENT
(1) Identify each state statute, federal statute, or federal regulation that requires or authorizes the action taken by the administrative regulation:
KRS 15.180, 367.150(4), 367.480, 367.484(5)
(2) State whether this administrative regulation is expressly authorized by an act of the General Assembly, and if so, identify the act:
(2) State whether this administrative regulation is expressly authorized by an act of the General Assembly, and is so, identify the act: 1960 Ky. Acts ch. 68, Art. II, sec. 1, effective March 17, 1960; 1972 Ky. Acts ch. 4, sec. 4; and 1988 Ky. Acts ch. 367, sec. 1, effective July 15, 1988.
(3)(a) Identify the promulgating agency and any other affected state units, parts, or divisions:
The Office of Attorney General, Kentucky Office of Regulatory Relief ("Attorney General") is the promulgating agency. The regulation does not affect any other state agencies. (b) Estimate the following for each affected state unit, part, or division in (3)(a):
(b) Estimate the following for each affected state unit, part, or division identified in (3)(a):
1. Expenditures:
For the first year:
There are no expenditures to administer this administrative regulation for the first year.
For subsequent years:
There will be no expenditures to administer the administrative regulation in subsequent years.
2. Revenues:
For the first year:
The administrative regulation will generate no revenues to the Attorney General in the first year. Registration fees referenced in the regulation are established by statute.
For subsequent years:
The administrative regulation will generate no revenues to the Attorney General in subsequent years. Registration fees referenced in the regulation are established by statute.
3. Cost Savings:
For the first year:
In the first year, the Attorney General will have cost savings from efficient and quicker processing of applications which are difficult to estimate at this time but estimated to be de minimis.
For subsequent years:
In subsequent years, the Attorney General will have cost savings from efficient and quicker processing of applications which are difficult to estimate at this time but estimated to be de minimis.
(4)(a) Identify affected local entities (for example: cities, counties, fire departments, school districts):
The administrative regulation will not affect any local entities.
(b) Estimate the following for each affected local entity identified in (4)(a):
1. Expenditures:
For the first year:
This administrative regulation will not cause expenditures by local entities for the first year.
For subsequent years:
This administrative regulation will not cause expenditures by local entities in subsequent years.
2. Revenues:
For the first year:
Local entities will receive no revenues from this administrative regulation for the first year.
For subsequent years:
Local entities will receive no revenues from this administrative regulation in subsequent years.
3. Cost Savings:
For the first year:
Local entities will receive no cost savings from this administrative regulation for the first year.
For subsequent years:
Local entities will receive no cost savings from this administrative regulation for subsequent years.
(5)(a) Identify any affected regulated entities not listed in (3)(a) or (4)(a):
Health spas will be affected by this administrative regulation will be affected by this administrative regulation.
(b) Estimate the following for each regulated entity identified in (5)(a):
1. Expenditures:
For the first year:
This administrative regulation will not cause health spas to have any additional expenditures for the first year.
For subsequent years:
This administrative regulation will not cause health spas to have any additional expenditures for subsequent years.
2. Revenues:
For the first year:
Health spas will not receive any revenues directly from this administrative regulation for the first year.
For subsequent years:
Health spas will not receive any revenues directly from this administrative regulation for subsequent years.
3. Cost Savings:
For the first year:
For the first year, health spas will receive cost savings from quicker processing of applications. These cost savings are difficult to estimate at this time but estimated to be de minimis.
For subsequent years:
For subsequent years, health spas will receive cost savings from quicker processing of applications. These cost savings are difficult to estimate at this time but estimated to be de minimis.
(6) Provide a narrative to explain the following for each entity identified in (3)(a), (4)(a), and (5)(a)
(a) Fiscal impact of this administrative regulation:
This administrative regulation will have no fiscal impact. The new regulation merely creates a registration application form, renewal application form, and surety bond form for use by health spas. The regulation does not affect any other governmental agencies or local governments. The regulation does not establish any fees. For these reasons, the regulation is not expected to have any significant fiscal impact.
(b) Methodology and resources used to reach this conclusion:
The Attorney General used a quantitative methodology analysis based on history of administrative agencies which license or register businesses in a specific subject area and the resulting facts from this regulation. The Attorney General used staff resources in determining the fiscal impact.
(7) Explain, as it relates to the entities identified in (3)(a), (4)(a), and (5)(a):
(a) Whether this administrative regulation will have a "major economic impact", as defined by KRS 13A.010(14):
There is not an expected "major economic impact" from this regulation for the Attorney General, any local entities, or affected regulated entities.
(b) The methodology and resources used to reach this conclusion:
The Attorney General used a quantitative methodology analysis based on history of administrative agencies which license or register businesses in a specific subject area and resulting facts from this regulation. The Attorney General used staff resources in reaching the conclusion that no overall negative or adverse major economic impact results from this administrative regulation.