Statement of Scope
Department of
Health Services
Rule No.
:
|
Chapter
s
DHS
161 and 161
A
ppendix A
(Renumbered
chs
. SPS 220 and 220 Appendix A July 1, 2016)
|
Relating to
:
|
Tanning Facilities
|
1. Finding/nature of emergency (Emergency Rule only):
N/A
2
.
Detailed description of the objective of the
proposed
rule
:
2015 Wisconsin Act 55
transferred responsibility for
regulating
tanning facilities from the Department of Health Services (DHS) to the Department of Safety and Professional Services (DSPS), effective January 1, 2016.
The department proposes modifying
ch.
DHS 161
(
ch.
SPS 220
)
, Tanning Facilities, and
its appendix,
DHS 161 Appendix A
(
ch.
SPS 220 Appendix A
)
,
to
align the
se
administrative
rule
s
with DSPS’s licensing and other administrative processe
s
and
modernize the rule
, as needed,
to reflect current practice
for ensuring the safe
and sanitary
use of tanning
devices.
3
.
Description of the existing policies relevant to the rule, new policies proposed to be included in the rule, and an analysis of policy alternatives
:
DHS 161
and 161
A
ppendix A
(
ch.
SPS 220
and
220
Appendix
A
)
implement
statutory requirements found in
s.
255.08
, Stats.
DHS 161
(
ch.
SPS 220
)
includes requirements
for
issuing
, denying, suspending and revoking tanning facility
permits
; requirements that tanning facilities
disp
lay and
provide
certain health information
to customers;
and
requirements
prohibit
ing
the
use of a tanning device by a person under 16 years old
,
as required by law
. The rule
also
outlin
es
procedures for the safe and sanitary use of tanning devices
and
injury reporting procedures
.
DHS 161 Appendix A
(
ch.
SPS 220 Appendix A
)
includes a table describing
sun-reaction for various skin types to be used to determine appropriate exposure times as recommended by the tanning device manufacturer.
The department’s tanning regulations have not been updated since they were first adopted in 1993.
The department issues permits for approximately 1,000 tanning facilities.
2015 Wisconsin Act 55
transfer
s
responsibility for the tanning facility program from DHS to DSPS
effective January 1, 2016
.
Approval of this
scope statement will allow DHS
and
DSPS
,
working
in consultation with industry
and public health
representative
s
,
to begin to
review and
revise DHS 161 and 161
A
ppendix A
(
ch.
SPS 220
and
220
Appendix
A
)
prior to the program’
s transfer
.
If the rule
s
are not
updated
,
they will contain references that are
in
consistent with DSPS administrative processes
after the program is transferred
, potentially causing confusion for
Wisconsin’s
tanning
facility owners and operators and tanning facility users
.
Without revision
, the
rules
also
may
not reflect current practice for protecting public health and safety
in tannin
g facilities.
4
.
Detailed explanation of statutory authority for the rule
(including
the
statutory citation and language):
The department has authority for promulgating rules related to tanning under ss.
255.08 (12)
, and
254.34 (1) (a)
,
Stats.
,
as follows:
255.08(12) - Tanning facilities.
255.08
(12) RULES. The department may promulgate rules necessary to administer this section.
254.34(1
)(
a) – Powers and duties.
254.34(1)
The
department is the state radiation control agency and shall do all of the following:
254.34(1)(a)
(a)
Promulgate and enforce rules, including registration and licensing of sources of ionizing radiation, as may be necessary to prohibit and prevent unnecessary radiation exposure.
5
.
Estimate of amount of time that state employees will spend developing the rule and of other resources necessary to develop the rule
:
160
hours.
6
.
List with description of all entities that
may
be affected by the proposed rule
:
The proposed rule
revision
will
benefit
tanning facility
owner
s
and
operators
by ensuring the rule reflects appropriate licensing and administrative procedures. It will
benefit
consumers by ensuring the rule reflects current information regarding the safe use of tanning devices.
7
.
Summary and preliminary comparison with any existing or proposed federal regulation that is intended to address the activities to be regulated by the proposed rule
:
21 CFR 1040.20
establishes performance standards for sunlamp and sunlamp products
and
inclu
des
equipment requirements
related to radiant power of sunlamps, requirements for timer systems,
and requirements for
protective eyewear
.
A
long with other labeling requirements,
the regulation includes
a requirement for sunlamps to display
a
warning statement
similar to the statement required by s.
255.08 (4)
and
DHS 161.07
. It also
requires
users’ instructions
to
include, among other items, instructions for determining the correct exposure time and schedule for persons according to skin type
, similar to the information provided in DHS 161 Appendix A
.
21 CFR 878.463
regulates sunlamp products and ultraviolet lamps intended for use in sunlamp products. In 2014, the Food and Drug Administration (FDA) revised this rule to reclassify sunlamp and ultraviolet
(UV)
lamps from low-risk (class I) to moderate-risk (class II) devices.
This reclassification placed additional controls on sunlamps and UV lamps to protect public health, such as performance testing, software validation, and demonstration that the device is biocompatible and safe to use.
The rule
requires
that
sunlamp products carry a visible black-box warning
stating
the product should not be used on people under age 1
8.
Finally, i
t
requires
that
user instructions, consumer-directed catalogs, specification sheets, descriptive brochures, and web-pages in which sunlamps or UV lamps are offered for sale
include
warnings that the product should not be used by people under the age of 18, people who have skin lesions or open wounds, people who have or have a history of skin cancer or
by people
who have been regularly evaluated for skin cancer.
8
. Anticipated economic impact of implementing the rule
(note if the rule is likely to have a significant economic impact on small businesses)
:
This rule
is not anticipated to
result in revisions that will
have a
negative
economic impact
on business
. It will
not have a significant economic impact
on small businesses.
Contact:
William
Balke
, Radiation Engineering Specialist Supervisor, Radiation Protection Section, Department of Health Services, 267-4787
