PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:

Addition of Subpart 72-1 to Title 10 NYCRR.

Tanning Facilities.

To establish standards for the safer and sanitary operation of Tanning Facilities.

The proposed Subpart contains the following provisions:

The term ‘tanning facility’ is defined and operators are required to obtain a biennial permit to operate from the permit issuing official (PIO) having jurisdiction in the county where the tanning facility is located. This may be the State, or the County or other specified local health officer when such officer requests to be authorized as a PIO. Inspection of facilities and enforcement of the Subpart by the PIO is established by this proposed regulation, as well as specifying operation standards for tanning facilities. The standards include age restrictions for use of ultraviolet radiation devices, requirements for patron identification, warning and consent requirements, operation and maintenance of physical facilities and equipment, use of protective eyewear during tanning and general operator responsibilities.

Nonsubstantive changes were made in sections 72-1.1, 72-1.3, 72-1.4, 72-1.6, 72-1.7, 72-1.8 and 72-1.9.

Katherine Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, (518) 473-7488, email: [email protected]

Statutory Authority:

The Commissioner is authorized by Public Health Law (PHL) Article 35-A Sections 3551 and 3554 to promulgate rules and regulations necessary to effectuate the provisions of the Article.

Needs and Benefits:

In July 1990, Article 35-A of the Public Health Law (PHL) was enacted giving the Department of Health the authority and responsibility to license and inspect ultraviolet radiation devices in tanning facilities, effective July 1991. The legislation established a program that includes biennial licensure and inspection of all commercial non-medical tanning operations. The purpose of this program is to license and inspect commercial tanning facilities with the intent of increasing consumer knowledge of the hazards of ultraviolet tanning and minimizing user injuries.

On August 14, 2006, Chapter 573 of Laws of 2006 amended Article 35-A to prohibit children under 14 years old from using tanning facilities and requiring that children between the ages of 14 and 18 have a parent or legal guardian sign a consent form before the child can use the tanning equipment. Adults must sign a similar statement indicating that they have read the Department's warning materials. The amendments to Article 35-A became effective November 14, 2006. The enacting legislation authorized the Commissioner to promulgate regulations to implement the amendments to the law.

Regulated Parties:

There are approximately 1,800 tanning facilities in New York State. Five counties in New York State have established or are in the process of establishing local regulations which provide performance standards and enable them to permit and inspect tanning facilities. The remaining counties and New York City have not enacted local regulations or established programs to regulate and permit tanning facilities as required by PHL Article 35-A.

Costs to Regulated Parties:

The proposed regulation creates no significant cost to tanning facility operators aside from biennial license and inspection fees established within Article 35-A. Minimal expenses may also be incurred by operators who currently do not provide protective eyewear "free of charge" as required by PHL Article 35-A. In these cases, operators will likely provide inexpensive single use disposable eyewear, which most operators currently sell to patrons for about $1.00 per set of eyewear. This disposable eyewear is readily available through wholesale, retail and internet sales and can be purchased for less than $0.20 per pair.

Some operators may have equipment that requires retrofitting to achieve compliance with the requirements within this regulation for ultraviolet device timer access controls. Research indicates that even the most expensive remote timer systems would cost less than $300 per unit to retrofit ultraviolet radiation devices to meet the requirements of this regulation. A less costly option exists, adding a patron lockout to the existing device timer. Estimates obtained indicate that this option would cost less than $50 per device to achieve compliance with the regulation for those operators whose equipment does not already meet the requirement.

Government:

The printing and distribution of the new regulation and the corresponding program inspection report, warning sign, information sheet, consent and acknowledgement forms will be a minimal State Health Department expense. There will be additional costs for staff time and travel expenses to train and to provide technical guidance to voluntary local health department (LHD) staff. Costs will be offset by additional revenue generated from permit and inspection fees. It is expected that PIOs will use existing staff to manage the workload because of the relatively low number of tanning facilities in any particular jurisdiction. Reimbursement to PIOs will be at the current State Aid rate of 36% for public health programs.

Alternatives Considered:

No alternatives were considered as compliance is mandated by Public Health Law. The proposed regulation meets the requirements established by PHL Article 35-A and would effectuate the provisions of the article as intended.

Compliance Schedule:

The proposed regulation will be effective upon publication of a notice of adoption in the State Register.

Effect on Small Business and Local Government:

There are approximately 1,800 tanning facilities in New York State, most of which are not currently under regulation. It is believed that most of these tanning facilities may be considered small businesses.

Compliance Requirements:

Reporting and Recordkeeping:

Tanning facility operators will be required to report certain patron injuries and illnesses within 24 hours of occurrence, and to maintain written records of such events for a period of two years. Operators must document the age of patrons and obtain a signed acknowledgement form from every adult patron. Operators must obtain parental consent forms for every minor patron from the ages of 14 to 18 years. These forms expire 12 months from the date of signing. Operators will also be required to test the accuracy of tanning device timers annually, and keep records of this activity. They shall also be required to keep equipment maintenance logs and to keep entries in these logs for a period of two years.

Other affirmative acts:

Tanning facility operators are required to obtain a biennial permit to operate from the permit issuing official (PIO) having jurisdiction in the county that the facility is located. Operators must check the identification of every prospective patron, ensuring that it meets the criteria set forth in PHL 35-A. Operators must also ensure that every patron has in their possession a set of adequate protective eyewear for use with ultraviolet radiation devices. For patrons without such eyewear, the operator must provide a set at no additional charge to the patron. Operators must also ensure that all ultraviolet radiation devices are adequately labeled, operated and maintained.

Compliance Costs:

The proposed regulation creates no significant cost to most tanning facility operators aside from biennial license and inspection fees established within Article 35-A. A facility permit fee of $30 and an inspection fee of $50 per ultraviolet radiation device will be assessed biennially.

Some operators may have equipment that requires retrofitting to achieve compliance with the requirements within this regulation for ultraviolet device timer access controls. Research indicates that even the most expensive remote timer systems would cost less than $300 per unit to retrofit ultraviolet radiation devices with a remote access system to meet the requirements of this regulation. Costs depend largely on prevailing rates charged by electrical contractors. A less costly option exists, adding a patron lockout to the existing device timer. Estimates obtained indicate that this option would cost less than $50 per device to achieve compliance with the regulation for those operators whose equipment does not already meet the requirement.

Minimal additional expenses may also be incurred by operators who are not currently providing protective eyewear "free of charge" as required by PHL Article 35-A. In these cases, operators will likely provide inexpensive single use disposable eyewear, which most operators currently sell to patrons for about $1.00 per set of eyewear. This disposable eyewear is readily available through wholesale, retail and internet sales and can be purchased for less than $0.20 per pair.

Operators may incur a minimal expense to obtain and post warning signs as required by the proposed regulations.

Professional Services:

These regulations do not impose any additional burden for professional services.

Economic and Technological Feasibility:

The proposal is technologically feasible because it requires the use of existing technology. The overall economic impact to comply with the requirements of this regulation is expected to be minimal.

Minimizing Adverse Economic Impact:

The proposed regulation establishes standards for operating ultraviolet radiation devices within tanning facilities in such a way as to minimize risk to the public health. Should this regulation have a substantial adverse impact on a particular facility, a waiver of one or more requirements other than those required by Article 35-A of Public Health Law will be considered, so long as alternative arrangements protect public health and safety.

Alternatively, a variance, allowing additional time to comply with one or more requirements, can be granted if the health and safety of the public is not prejudiced by the variance.

Small Business Participation:

During the development of this regulation, Department staff met with representatives of the Indoor Tanning Association, which represents approximately 23 NYS tanning operators, and several small business owners on several occasions and also had numerous telephone conversations to develop a better understanding of tanning facility operations. This information obtained during these outreach activities was incorporated into the proposed regulation. Furthermore, Department staff were invited to observe several small tanning business operations in person, and knowledge gleaned during these on-site observations was critical in the development of the proposed regulations. Small business participation included six operators in Saratoga County and two in Dutchess County.

Types and Estimated Number of Rural Areas:

There are approximately 1800 tanning facilities in New York State. Approximately forty percent are located in rural areas throughout the state, as determined by a survey of all local health departments in November 2006.

Reporting, Recordkeeping and Other Compliance Requirements; and Professional Services:

Reporting and Recordkeeping:

Tanning facility operators will be required to report certain patron injuries and illnesses within 24 hours of occurrence, and to maintain written records of such events for a period of two years. Operators must document the age of patrons and obtain a signed acknowledgement form from every adult patron. Operators must obtain parental consent forms for every minor patron from the ages of 14 to 18 years. These forms expire 12 months from the date of signing. Operators will also be required to test the accuracy of tanning device timers annually, and keep records of this activity. They shall also be required to keep equipment maintenance logs and to keep entries in these logs for a period of two years.

Other affirmative acts:

Tanning facility operators are required to obtain a biennial permit to operate from the permit issuing official (PIO) having jurisdiction in the county that the facility is located. Operators must check the identification of every prospective patron, ensuring that it meets the criteria set forth in PHL 35-A. Operators must also ensure that every patron has in their possession a set of protective eyewear that meets United States Food and Drug Administration standards for use with ultraviolet radiation devices. For patrons without such eyewear, the operator must provide a set at no additional charge to the patron. Operators must also ensure that all ultraviolet radiation devices are adequately labeled, operated and maintained.

Compliance Costs:

The proposed regulation creates no significant cost to most tanning facility operators aside from biennial license and inspection fees established within Article 35-A. A facility permit fee of $30 and an inspection fee of $50 per ultraviolet radiation device will be assessed biennially.

Some operators may have equipment that requires retrofitting to achieve compliance with the requirements within this regulation for ultraviolet device timer access controls. Research indicates that even the most expensive remote timer systems would cost less than $300 per unit to retrofit ultraviolet radiation devices with a remote access system to meet the requirements of this regulation. Costs depend largely on prevailing rates charged by electrical contractors. A less costly option exists, adding a patron lockout to the existing device timer. Estimates obtained indicate that this option would cost less than $50 per device to achieve compliance with the regulation for those operators whose equipment does not already meet the requirement.

Minimal additional expenses may also be incurred by operators who are not currently providing protective eyewear "free of charge" as required by PHL Article 35-A. In these cases, operators will likely provide inexpensive single use disposable eyewear, which most operators currently sell to patrons for about $1.00 per set of eyewear. This disposable eyewear is readily available through wholesale, retail and internet sales and can be purchased for less than $0.20 per pair.

Operators may incur a minimal expense to obtain and post warning signs as required by the proposed regulations.

Professional Services:

These regulations do not impose any additional burden for professional services.

Minimizing Adverse Economic Impact on Rural Areas:

The proposed regulation establishes standards for tanning facilities to minimize risk to the public health. Should this regulation have a substantial adverse impact on a particular facility, a waiver of one or more requirements other than those required by Article 35-A of Public Health Law will be considered, so long as alternative arrangements protect public health and safety. Alternatively, a variance, allowing additional time to comply with one or more requirements, can be granted if the health and safety of the public is not prejudiced by the variance.

Rural Area Participation:

During the development of this regulation, the Department met with industry representatives on several occasions and had numerous telephone conversations to develop a better understanding of tanning facility operation and incorporated the information obtained during these outreach activities into the proposed regulation. Furthermore, Department staff were invited to observe several small tanning business operations in person. Some of these facilities were in rural areas. Knowledge gleaned during these on-site observations was critical in the development of the proposed regulations.

Changes made to the last published rule do not necessitate revision to the previously published JIS.

A total of seventeen (17) letters containing comments were received from tanning facility operators, local health departments (and a county board of supervisors), an industry membership association, and from the director of a not-for-profit entity. A review of the comments has been performed and the following is a summary of the major comments.

Section 72-1.1 Definitions

Comment:

The New York City Department of Health and Mental Hygiene stated that the regulation created an unfunded mandate and impermissible shift of statutory obligations from the State to City and County Health Departments.

They further contend that the only authority in Public Health law Article 35-A for the State Department of Health (DOH) to delegate any of its responsibilities to City and County Health Departments is in Section 3554. Their interpretation is that DOH cannot directly require the implementation of requirements or enforcement of the Public Health Law sections that precede (Licenses, Fees) or 2006 amendments that follow that section (age restrictions, written consent).

One county board of supervisors also submitted a resolution opposing the proposed regulations as an unfunded mandate. One other local health department had a similar comment concerning lack of funding and resources to implement the program.

Response:

Agree. The delegation or authorization of a City or County Health Department is to be made in response to a request by a County or City Health Department to the State Health Commissioner to implement the proposed regulatory program. To address this issue, the Permit Issuing Official (PIO) definition was clarified indicating that when designated by the State Health Commissioner, City and County Health Departments could participate in this optional program. The regulations therefore will not impose any local government mandates. City and County Health Departments that wish to act as the PIO to enforce these regulations can request an approval for authorization from the State Commissioner of Health. The State Department of Health will assume responsibility for program implementation in all other locations.

Section 72-1.4 Permits and Fees

Comment:

Nine operators and an industry tanning association objected to permit and/or inspection fees; several stated that fees were excessive and suggested a cap on inspection fees. Several comments were received from local health departments and NYC regarding inability of current fee structure to support the program. They also contend that PHL Article 35-A requires that any fees collected can only offset costs incurred by the State, that City and County Health Departments cannot collect permit or inspection fees.

Response:

No change. Fees are set in Public Health Law Article 35-A.

Section 72-1

Comment:

Four operators objected to having to provide free protective eyewear to patrons that do not possess their own protective eyewear.

Response:

No Change. Public Health law Article 35-A requires each tanning facility to provide safety goggles and any other safety-related devices to customers without additional charge.

Comment:

A not for profit entity generally supported the regulation but would like to see a total ban on tanning for children under age 18.

Response:

The current age restriction for tanning of minors is established in Public Health Law Article 35-A. A change in the statute or adoption of a more stringent local law would be needed.

Other comments:

Two County Health Departments and the Indoor Tanning Association asked for guidance regarding sanitizing products and procedures.

One operator asked for guidance regarding testing of timer accuracy.

One operator asked for guidance regarding proof that an adult was a parent or legal guardian of a minor.

Several other comments were received relating to general program administration.

Response:

No change. Most of these are technical and procedural questions that can be addressed through guidance documents and fact sheets.